LIAISON
®
XS
cod. I0090
USER MANUAL
en-UK - Revision H
02/2026
DISCLAIMER
The information contained herein is based on experience and knowledge relating to the subject matter as
acquired by DiaSorin Italia S.p.A.
DiaSorin is not liable for any loss or damage, including consequential or special damages resulting from the
use and or misuse of the contained information be it negligence or other fault.
This document refers to access at the highest level. Working with lower level access may cause a lack of some
functionalities.
LIAISON
®
XS may only be used by authorized and trained personnel.
This document cannot be considered substitutive of official trainings supported by DiaSorin.
In the event of problems or doubts about using the system, contact the local support.
A document that states the list of LIAISON
®
XS Software Versions that are covered by the present User Manual
revision will be provided separately.
The previous legal manufacturer of LIAISON
®
XS was DiaSorin S.p.A.
DiaSorin Italia S.p.A.
Strada per Crescentino - 13040 Saluggia (Vercelli) - Italy
www.diasorin.com
DiaSorin Italia S.p.A. All rights reserved
AMENDMENT INDEX
Revision
Impacted
chapter/section
Description of Change(s)
H 1.5.3 Update IFU icon description as per EN ISO 15223:2021
H 1.7.2 Remove year from the ISO 14971
H 11.1 Update IFU icon description as per EN ISO 15223:2021
H 11.1.1 New paragraph EMC compliance
H 11.1.2 New paragraph FCC Radio User Manual Guidance
H 11.2.1 New paragraph ISED Canada Radio User Manual Guidance
H 11.3 New Brazilian distributor address
LIAISON
®
XS - User Manual Page I
1 Introduction ......................................................................................1-1
1.1 Description ..........................................................................................................1-1
1.2 Customer Support ..............................................................................................1-1
1.3 Proprietary Statement ........................................................................................1-1
1.4 Authorization and disclaimers about Documentation ....................................1-2
1.5 Messages, Notes and Symbols .........................................................................1-3
1.6 Hazard Instructions ............................................................................................1-6
1.7 Safety residual Risks for User.........................................................................1-15
1.8 Instrument Labeling and Safety Labels..........................................................1-22
1.9 Operational Precautions and limitations........................................................1-39
1.10 Installation of the System ................................................................................1-41
1.11 Removal of the System ....................................................................................1-42
2 PC security measure .......................................................................2-1
2.1 Introduction.........................................................................................................2-1
2.2 Unauthorized local access.................................................................................2-1
2.3 Malware................................................................................................................2-2
2.4 Unauthorized network access ...........................................................................2-3
2.5 System update ....................................................................................................2-3
2.6 Local/network printing .......................................................................................2-4
2.7 Desktop Sharing .................................................................................................2-4
2.8 IoT connection ....................................................................................................2-5
2.9 Privacy .................................................................................................................2-5
2.10 Security Requirements for Operating Environment........................................2-7
Table of Contents
Page II LIAISON
®
XS - User Manual
3 Measuring principle of the LIAISON
®
XS immunoassay..............3-1
3.1 Explanations for Steps of Assays.....................................................................3-1
3.2 Measuring Principle............................................................................................3-3
3.3 Measuring Function Description.......................................................................3-3
3.4 Calibration (quantitative) ...................................................................................3-4
3.5 Calibration (qualitative)......................................................................................3-5
4 System description..........................................................................4-1
4.1 Overview..............................................................................................................4-1
4.2 Use of the Modules.............................................................................................4-9
5 Use of the System............................................................................5-1
5.1 Safety and Hints..................................................................................................5-1
5.2 Typographical Conventions ..............................................................................5-1
5.3 Start up ................................................................................................................5-4
5.4 Check Cuvettes, Disposable Tips, Starter Reagents and Liquid Tanks........5-7
5.5 Load Patient Samples or Controls and Assign Assays ................................5-45
5.6 Integrals, Calibrators, Ancillary reagents.......................................................5-55
5.7 Start Worklist ....................................................................................................5-64
5.8 Results...............................................................................................................5-65
5.9 Routine errors ...................................................................................................5-74
5.10 Unloading ..........................................................................................................5-75
5.11 Shutdown/End of Day Activities......................................................................5-79
6 Software Functions..........................................................................6-1
6.1 Software Startup.................................................................................................6-1
6.2 Login Screen.......................................................................................................6-2
6.3 General ................................................................................................................6-3
6.4 Left header ........................................................................................................6-16
6.5 Main Category Loading ....................................................................................6-21
LIAISON
®
XS - User Manual Page III
6.6 Main Category Results .....................................................................................6-40
6.7 Main Category Events ......................................................................................6-73
6.8 Main Category Definitions ...............................................................................6-78
6.9 Main Category System ...................................................................................6-101
6.10 Main Category Diagnostics............................................................................6-119
6.11 Main Category Maintenance ..........................................................................6-121
6.12 Main Category Status .....................................................................................6-126
7 Maintenance .....................................................................................7-1
7.1 Safety and hints..................................................................................................7-1
7.2 Scheduled Maintenance Tasks..........................................................................7-3
7.3 Preparation of the Cleaning Solution in the cleaning tank.............................7-3
7.4 Short and Long Term Maintenance...................................................................7-4
7.5 Clean the wash buffer and the system liquid tanks ........................................7-4
7.6 Manual Cleaning of the instrument...................................................................7-6
7.7 LIAISON
®
EASY Cleaning Tool..........................................................................7-7
7.8 Automated actions performed by the system..................................................7-8
8 Troubleshooting and error messages ...........................................8-1
8.1 SPOLVRightArm .................................................................................................8-1
8.2 SingleSledgeZ .....................................................................................................8-3
8.3 SingleSledgeY.....................................................................................................8-5
8.4 Pipettor ................................................................................................................8-7
8.5 LWP....................................................................................................................8-11
8.6 Gripper...............................................................................................................8-12
8.7 DualSledgeZ ......................................................................................................8-13
8.8 DualSledgeY......................................................................................................8-14
8.9 AirPipettorLeftArm ...........................................................................................8-16
8.10 ComGenDriver ..................................................................................................8-18
8.11 FrontCoverDriver..............................................................................................8-19
Page IV LIAISON
®
XS - User Manual
8.12 LiquidSupportDriver.........................................................................................8-20
8.13 ReagentSampleBayDriver................................................................................8-21
8.14 MeasurementDriver ..........................................................................................8-22
8.15 WasherDriver ....................................................................................................8-23
8.16 IncubatorDriver .................................................................................................8-24
8.17 ServiceDriver.....................................................................................................8-25
8.18 UserAccessDriver.............................................................................................8-26
8.19 DiTiManager ......................................................................................................8-26
8.20 LoadingManager ...............................................................................................8-27
8.21 Dispatcher .........................................................................................................8-28
8.22 AssayManager ..................................................................................................8-29
8.23 JobManager.......................................................................................................8-31
8.24 FrontCover ........................................................................................................8-33
8.25 WAP ...................................................................................................................8-34
8.26 WasherDispensePump.....................................................................................8-35
8.27 LiquidSupport ...................................................................................................8-37
8.28 LoadingBay .......................................................................................................8-38
8.29 PumpStarter2 ....................................................................................................8-41
8.30 PumpStarter1 ....................................................................................................8-42
8.31 Measurement.....................................................................................................8-44
8.32 Washer...............................................................................................................8-47
8.33 Incubator ...........................................................................................................8-51
8.34 UserAccessPanel..............................................................................................8-52
8.35 PwrCanExtension .............................................................................................8-52
8.36 COP ....................................................................................................................8-53
8.37 QCStat................................................................................................................8-54
8.38 Backup...............................................................................................................8-55
8.39 AutoBackup.......................................................................................................8-56
8.40 DataReduction ..................................................................................................8-57
8.41 TDef....................................................................................................................8-58
LIAISON
®
XS - User Manual Page V
8.42 ICoL....................................................................................................................8-59
8.43 LIS ......................................................................................................................8-60
8.44 Reporting...........................................................................................................8-61
8.45 UI ........................................................................................................................8-62
8.46 Maintenance......................................................................................................8-64
8.47 Waste .................................................................................................................8-66
8.48 TopCover ...........................................................................................................8-67
8.49 StarterLoading ..................................................................................................8-67
8.50 SampleLoading .................................................................................................8-69
8.51 ReagentLoading................................................................................................8-70
8.52 LiquidContainers ..............................................................................................8-73
8.53 Consumables ....................................................................................................8-74
8.54 AncillaryLoading...............................................................................................8-75
8.55 Infrastructure ....................................................................................................8-77
8.56 ProcessControl .................................................................................................8-80
8.57 InstrumentControl ............................................................................................8-89
8.58 Database............................................................................................................8-91
8.59 ComProtocol .....................................................................................................8-92
8.60 Application ........................................................................................................8-93
9 Technical data ..................................................................................9-1
9.1 Power requirements ...........................................................................................9-1
9.2 Laser barcode scanner ......................................................................................9-1
9.3 Computer and connections ...............................................................................9-2
9.4 Dimensions and weight......................................................................................9-2
9.5 System clearance ...............................................................................................9-3
9.6 Environmental conditions..................................................................................9-4
9.7 Noise emission ...................................................................................................9-4
9.8 Temperature Ranges..........................................................................................9-4
9.9 Water quality .......................................................................................................9-5
Page VI LIAISON
®
XS - User Manual
10 Disinfection procedure..................................................................10-1
10.1 Introduction.......................................................................................................10-1
10.2 Hazards..............................................................................................................10-2
10.3 Alcoholic solution specifications....................................................................10-4
10.4 Preparation of sodium hypochlorite solution ................................................10-4
10.5 Disinfection procedure Task ...........................................................................10-5
11 Country Specific Notes .................................................................11-1
11.1 USA ....................................................................................................................11-1
11.2 Canada...............................................................................................................11-4
11.3 Brazil ..................................................................................................................11-4
11.4 China..................................................................................................................11-4
1. Introduction
LIAISON
®
XS - Instruction for use Rev. H Page 1-1
1 Introduction
This manual was created to assist the laboratory user with the utilization of the
LIAISON
®
XS chemiluminescence analyzer. This manual includes specific definitions as
well as handling and maintenance of the instrument.
1.1 Description
The system consists of a robotic instrument, a Panel-PC and software that runs on the
Panel-PC. The software provides the user-interface that gives the operator the ability to
control the system, and the software performs data reduction on the measurement results
(measured by the instrument).
The instrument contains a transport system for plastic cuvettes, a pipetting system with two
pipetting arms (one with a steel needle and one that uses disposable tips), an incubator,
a washer and a luminescence measurement chamber. In addition to that, the instrument
contains modules for loading samples, reagents, tips and cuvettes into the instrument.
Panel-PC and instrument are connected to exchange data.
1.1.1 Intended Use
This manual covers the following products:
• LIAISON
®
XS: Diagnostic System that measures chemiluminescence. It is intended
strictly for professional In-vitro-Diagnostic use. It is to be used only with
Chemiluminescence Immunoassays, authorized by DiaSorin Italia S.p.A. for the
LIAISON
®
XS instrument.
For Professional Use Only.
1.2 Customer Support
If you have any questions about the LIAISON
®
XS Diagnostic System, please contact your
local DiaSorin Italia S.p.A. Customer Support Representative to get answers to your
inquiries.
For EU only: please be aware that any serious incident that has occurred in relation to this
IVD medical device should be reported to DiaSorin and the competent authority of the EU
Member State in which the user and/or patient is established.
1.3 Proprietary Statement
The LIAISON
®
XS System software programs and system documentation are protected by
copyright laws. All rights are reserved. The software and manual were developed solely for
use with the LIAISON
®
XS System and for in vitro diagnostic applications as specified in
the operating instructions.
The information, documents and related graphics published herein (the “Documentation” or
“Document”) are the sole property of DiaSorin Italia S.p.A. Permission to use the
Information is granted, provided that:
• use of the Documentation is for operating DiaSorin Italia S.p.A. products by
DiaSorin Italia S.p.A. trained personnel or informational use only;
• the copyright notice appears on all copies;
• the Documentation is not modified in any way; and
1. Introduction
Page 1-2 LIAISON
®
XS - Instruction for use Rev. H
• no graphics are used separately from accompanying text.
Each person assumes full responsibility and all risks arising from use of the Documentation.
The Documentation may include technical inaccuracies or typographical errors.
DiaSorin Italia S.p.A. reserves the right to make additions, deletions, or modifications to the
Documentation at any time without any prior notification.
1.4 Authorization and disclaimers about Documentation
The information contained herein is based on experience and knowledge relating to the
subject matter as acquired by DiaSorin Italia S.p.A.
This Document refers to access at the highest level. Working with lower level access may
cause a lack of some functionality.
The user manual and the LIAISON
®
XS Chemiluminescence instrument are to be used by
authorized personnel only. Operate the Instrument following the indications and procedures
described in the operating instructions for the LIAISON
®
XS instrument.
Follow all warnings, cautions, and notes indicated on the LIAISON
®
XS instrument and in
the operating instructions. Failure to do this may result in human injuries or damage to
instrument.
No part of this document may be reproduced, stored, retrieved, or transmitted in any form
or by any means without the prior written permission of DiaSorin Italia S.p.A.
All samples, if any (printouts, graphics, displays, screens, etc.), are for information and
illustration purposes only and shall not be used for clinical or maintenance evaluations.
Data shown in sample printouts and screens does not reflect actual patient names or test
results.
The Documentation was developed to be used by DiaSorin Italia S.p.A. trained personnel,
by other persons knowledgeable or experienced with the operation and service of the
product identified, or under the direct supervision and with cooperation from
DiaSorin Italia S.p.A. technical sales or service representatives.
All the Standards mentioned in the present User Manual are intended at their latest
revision, available at the date of the release of the Manual itself.
This Document cannot be considered substitutive of official trainings supported by
DiaSorin Italia S.p.A.
In no event shall DiaSorin Italia S.p.A. or its affiliates be liable for any damages or losses
incurred in connection with or arising from the use of the Documentation by persons not fully
trained by DiaSorin Italia S.p.A. This limitation shall not apply to those persons
knowledgeable or experienced with the operation and service of the product identified, or
under the direct supervision and with cooperation from DiaSorin Italia S.p.A. technical
sales or service representatives.
In the event that any user of the Information should make any questions, comments,
suggestions, ideas or any other kind of oral, written or electronic feedback to
DiaSorin Italia S.p.A., any information submitted therewith shall be considered non-
confidential, and DiaSorin Italia S.p.A. shall be free to reproduce, edit, publish or otherwise
use such information for any purposes whatsoever including, without limitation, the
research, development, manufacture, service, use, or sale of products incorporating such
information and no liability will be borne by DiaSorin Italia S.p.A. in connection with its
content, including its truthfulness and accuracy and its non-infringement of any other
person's proprietary rights.
Updates to the Documentation may be provided in either paper or electronic format. Always
refer to the latest documents for the most current information.
In the event of problems or doubts about using the system, contact your local support
representative.
1. Introduction
LIAISON
®
XS - Instruction for use Rev. H Page 1-3
1.5 Messages, Notes and Symbols
The symbols described hereafter are used in the current manual, on the instrument and on
its packaging.
1.5.1 Display of Warnings and Notes
1.5.2 Used warning symbols
The signal word “Danger” and a relating symbol point to imminent dangers.
The non-observance of a danger warning is imminent and might result in death or at least
serious irreversible injuries. A damage of the system or an adverse effect on the system
function cannot be excluded.
The signal word “Warning” and a relating symbol point to potential dangers.
The non-observance of a warning is potential and can result in death or at least serious
irreversible injuries. A damage of the system or an adverse effect on the system function
cannot be excluded.
The signal word “Caution” and a relating symbol point to potential dangers/
problems.
The non-observance of safety instructions can result in minor injuries. A damage of the
system or an adverse effect on the system function cannot be excluded.
The signal word “Caution” points to potential problems.
The non-observance of a safety instruction can result in damage of the system or an
adverse effect on the system function.
The signal word “Note” points to potential problems.
The non-observance of notes can result in an adverse effect on the system function
(result deterioration).
Caution, risk of danger to person or damage to equipment!
Consult instructions for use!
Biohazard!
Electrical hazard!
Laser hazard!
1. Introduction
Page 1-4 LIAISON
®
XS - Instruction for use Rev. H
First Type
Second Type
Laser hazard and laser information label
Caution, hot surface!
Crush hazard!
Magnetic field
Cut injury hazard!
No heavy load
Disconnect main power connector before servicing
Disconnect main power connector before servicing!
Power Supply characteristics
Grounding label
LAN connection
USB label
1. Introduction
LIAISON
®
XS - Instruction for use Rev. H Page 1-5
1.5.3 Other Symbols
Waste
Shockwatch label
Tiltwatch label
System Liquid Tank
Wash Buffer Tank
Liquid Waste Tank
Cleaning Tank
DI Water tank
Main Switch
Don’t step
Manufacturer
Date of manufacture
In vitro diagnostic medical device
CE mark
Catalogue number
1. Introduction
Page 1-6 LIAISON
®
XS - Instruction for use Rev. H
1.6 Hazard Instructions
1.6.1 General Safety
The following safety instructions must be observed at all times, both before and during
operation of the system.
The Instructions for use is provided for user safety and gives important instructions for the
handling of the system described.
• Before starting use of the LIAISON
®
XS Diagnostic System, read the following
explanations for safety carefully, and understand the contents completely.
User must be trained before being allowed to operate the system.
• Keep the Instructions for use near the system.
• When using reagents or chemicals, a properly well-ventilated room should be the
responsibility of the user. Failure to comply may result in health issues.
• For maintaining safety, do not modify the LIAISON
®
XS Diagnostic System, do not
change the components or accessories, do not use parts either than the specified,
and do not remove the safety devices.
• Installation and service of the system or changes in the installation may never be
performed by non-authorized persons not approved by DiaSorin Italia S.p.A.
Multiple plug sockets different from the one as installed by DiaSorin Italia S.p.A. or
its representative personnel are not allowed.
• Do not perform any operations or functions not described in the operating
instructions. If trouble occurs on the Diagnostic System, contact
DiaSorin Italia S.p.A., or an authorized representative.
• Cautions indicated on the LIAISON
®
XS Diagnostic System and in the operating
instructions are prepared after careful examination; however, phenomenon beyond
prediction may occur. When performing operation and maintenance, it is imperative
to follow the instructions correctly.
Serial number
Restriction of certain Hazardous Substances (RoHS)
in electronic equipment
Certification label of the Nemko GmbH & Co. KG
Consult electronic instructions for use
www.diasorin.com DiaSorin website
Toll free number
Disposal of Electrical and Electronic Equipment
In the European Union, electrical and electronic equipment
must not be disposed of with other household-type waste. It
must be collected separately. Please observe the relevant legal
regulations effective in the respective country.
Caution
1. Introduction
LIAISON
®
XS - Instruction for use Rev. H Page 1-7
• It is mandatory to allow DiaSorin Italia S.p.A. personnel, or an authorized
representative, to perform all scheduled and exceptional interventions on the
LIAISON
®
XS Diagnostic System that have been indicated as necessary to
guarantee the full operational conditions of the system.
• The Instructions for use must be accessible to the user at all times.
1.6.2 Liability
The LIAISON
®
XS Diagnostic System is designed and manufactured in accordance with
the safety requirements for electronic and medical systems. It is the operators’
responsibility to comply with local and national law's regulations and laboratory procedures
for installation and operation of the instrument.
The manufacturer has done everything possible to guarantee that the equipment functions
safely, both electrically and mechanically. The systems are tested by the manufacturer and
supplied in a condition that allows safe and reliable operation.
The information contained herein is based on experience and the best knowledge relating
to the subject matter as acquired by DiaSorin Italia S.p.A.
DiaSorin Italia S.p.A. is not liable for any loss or damage, including consequential or special
damages resulting from the use and or misuse of the contained information be it negligence
or other fault of personnel and/or contractors.
• The instrument may only be used in accordance with its intended use.
• Use only the consumables and accessories described herein (e.g. disposable tips,
cuvettes).
• The manufacturer assumes no liability for any damages, including those to third
parties, caused by improper use or handling of the system.
To guarantee the full operational conditions of the LIAISON
®
XS Diagnostic System, it is
mandatory to allow DiaSorin Italia S.p.A. personnel, or any field service authorized
representative, to perform all scheduled (one preventive maintenance per year) and
unscheduled interventions, whereby required under particular circumstances, including
but not limited to inappropriate use, over extraordinary workloads or any inconsistent use
in respect of DiaSorin Italia S.p.A. guidelines or recommendations. Ordinary instrument
workload is considered up to 180 determinations (assay results) per day.
Failure to adhere to the IFU may result in harm for the user or 3rd party persons,
damage to the system or adversely affect assay result. See section Operational
precautions and limitations.
Improper use of the system may result in wrong assay results, damage of the
system and personal injury.
1. Introduction
Page 1-8 LIAISON
®
XS - Instruction for use Rev. H
1.6.3 Electrical Hazards
The LIAISON
®
XS Diagnostic System does not pose uncommon electrical hazards to
operators if it is installed and operated without alteration and is connected to a power
source that meets required specifications. See Electrical requirements in chapter 9.1.
National rules and local regulations for the safe electrical operation of the system must be
observed.
Basic electrical hazard awareness is essential to the safe operation of any system.
Only qualified personnel should perform electrical servicing.
Elements of electrical safety include, but are not limited to the following:
• Where appropriate, the instrument is installed with additional external switch for
residual current circuit-breakers with over-current protection.
• Where appropriate it is integrated in UPS device.
• Use only connection and extension cables with a protective conductor and
sufficient capacity (performance, power) to connect the system and the peripheral
devices to the mains supply.
• Use a properly grounded electrical outlet of correct voltage and current handling
capability.
• Never interrupt the grounding contacts.
• Grounding of the system and its peripheral devices to the same protective earth
potential must be ensured.
• The multi plug possibly supported can be used only as installed by
DiaSorin Italia S.p.A. or its representative personnel. Do not add any other device
to the supplied multi plug.
• Determine and correct the cause of a blown fuse or thrown circuit breaker before
attempting to resume operation of the system.
• Do not disconnect any electrical connection or service any electrical or internal
components while the power is on.
• Keep liquids away from all connectors of electrical or communication components.
• Do not touch any switches or outlets with wet hands.
• Keep the floor dry and clean under and around the instrument.
• Disconnect the instrument power cord before cleaning major liquid spills.
• Clean spilled fluids immediately.
• Damaged connecting cables must be replaced immediately.
• No objects may be placed on the connecting cables.
• Connecting cables must be routed so that they cannot be squeezed or damaged.
• Connecting cables must be routed so that they do not lie in accessible or drivable
areas.
• Immediately separate the defective system from the mains supply, if a safe usage
is no longer possible.
• Secure the defective system against reconnection.
• Label the defective system clearly as being defective.
• Switch off the system, separate it from the mains supply and protect it against
restarting. When system is secured start cleaning, disinfection, decontamination,
maintenance or repair operations.
• Ensure that the system is free from personnel and that all covers are attached and
closed before reconnecting the system to the mains supply.
1. Introduction
LIAISON
®
XS - Instruction for use Rev. H Page 1-9
• Ensure the positioning of the system during installation is so that the power supply
and mains switch are easily accessible.
1.6.4 Physical Hazards
1.6.4.1 Laser Light Hazards
• The barcode reader is positioned on the right side of the Sample loading bay.
The laser beam exits from an opening positioned on the internal right side of the
sample loading bay. The laser beam is orthogonal to the internal right side surface.
• Never look directly into the laser beam.
• Do not introduce optical devices into the system.
• Remove watches and reflective jewelery before operating the laser.
• Caution during operation and testing the laser (bar-code scanner and handheld
barcode reader) must be taken due to the laser class (class 2).
Electrocution/Fire Hazard!
Non-observance of rules and regulations may cause serious personal injury with lethal
consequences and material damage.
Improper connection of the system and the peripheral devices to mains supply can cause
serious personal injury with lethal consequences and material damage (e.g. fire).
Damaged connecting cables can cause serious personal injury with lethal consequences
and material damage (fire).
Defective systems can result in serious injury with lethal consequences and material
damage (e.g. fire).
In case of accidental spilling or dropping on electrical or electronical parts or connections,
switch off the system and unplug from the mains supply. When the system is secured, call
Service support.
Danger of Electrocution or Mechanical Injury
If the system is not separated from the main supply before maintenance operations,
serious injury with lethal consequences due to electrocution may occur. Additionally, there
is the danger that the system starts and may cause injury (e.g. contusion, cuts etc.) to the
person working with the system.
Danger due to Improper Positioning of Installation
Improper placement of the system can cause accidents with serious injuries with lethal
consequences, fire or serious system damages because the system cannot be switched
off or be separated from the main supply.
Eye Injuries due to Laser Radiation
Laser radiation can cause eye irritations when looking into the laser beam for a long
period of time.
Incorrect usage of operating elements or of adjustments or the non-observance of
processes can cause a dangerous emission of laser radiation.
1. Introduction
Page 1-10 LIAISON
®
XS - Instruction for use Rev. H
1.6.4.2 Heavy Objects
• Use proper lifting techniques when handling full tanks (system liquid, wash, and
waste), the full waste basin and the full waste box.
• Use care when handling the tanks to reduce the risk of injury.
• Use care when handling the waste basin and the waste box, in order to avoid falls
of contaminated materials.
1.6.4.3 Trip Hazards
The LIAISON
®
XS Diagnostic System is equipped with power cords and various computer
connectors. To avoid tripping hazards, ensure cords are properly stowed.
1.6.5 Mechanical Hazards
The LIAISON
®
XS Diagnostic System is an automated system that operates under
computer control. As with most automated equipment, there is potential for injury and bodily
harm from moving mechanical components whenever the system is in operation.
The LIAISON
®
XS Diagnostic System minimizes mechanical hazards by providing guards
to protect against accidental contact with moving components, and encoding the software
with safety features.
During operation of the instrument, user is potentially exposed to the following moving
mechanical components:
• Pipettor arms and probes;
Basic elements of mechanical safety include, but are not limited to:
• Avoid contact with the sharp metal edges.
• Never bypass or override a safety device.
• Keep all protective covers and barriers in place.
• Never perform manual tasks on the work surface of the system.
• Never allow any part of your body to enter a range of mechanical movement during
system operation.
• Do not wear articles of clothing or accessories that could catch on the system.
Do not use the handheld barcode reader for purposes different from reading
bi-dimensional control definitions.
In the event of a damage, prejudice or personal injury occurred in connection with the use
of the LIAISON
®
XS Diagnostic System, the Field Service Engineer shall immediately
contact the local DiaSorin Italia S.p.A. Representative.
Overheating
Improper place of installation/operation of the system may cause fire or serious system
damage in case of overheating.
• Do not block or cover ventilation slots.
• The air shall be able to circulate.
1. Introduction
LIAISON
®
XS - Instruction for use Rev. H Page 1-11
• Keep pockets free of items that could fall into the system.
• The right pipettor probe is sharp and potentially contaminated with infectious
material. Avoid contact with the probe tip.
• Use caution when performing maintenance or cleaning procedures.
• Be aware that, in the event of a system malfunction or an unexpected sequence of
movements, reflex actions could occur, causing injury.
• Select the placement of the system so that the ventilation slots are not blocked or
covered.
• Select the placement of the system so that air can circulate.
• Never cover ventilation slots.
1.6.6 Biological Hazards
Performing the following activities user may be exposed to potentially infectious materials:
• Handling samples, reagents, calibrators, and controls;
• Cleaning spills;
• Handling and disposing of waste;
• Performing maintenance procedures;
• Performing cleaning or decontamination procedures.
The following information will help the user in minimizing the impact of this exposure.
User should consider all clinical samples, reagents, calibrators, controls, pipettor needles,
and used reaction vessels and consumables (e.g. tips, cuvettes) that contain human-
sourced material as potentially infectious. User should consider all system surfaces or
components that have come in contact with human-sourced material as potentially
infectious. No known test method can offer complete assurance that products derived from
human-sourced material will not transmit infection. Therefore, all products derived from
human-sourced materials and system components exposed to human-sourced materials
should be considered potentially infectious.
Precautions include, but are not limited to the following:
• Observe local and national provisions, legislation and laboratory regulations.
• Use appropriate disposable gloves.
• Use an appropriate lab coat.
• Use an appropriate eye protection.
• Avoid contact between skin/mucous membrane and samples/test reagents or parts
of the instrument.
• Do not pipette by mouth.
• Do not eat, drink, smoke, apply cosmetics or handle contact lenses when handling
human-sourced material or contaminated system components.
• Use proper personal protective equipments when interacting with the probe for
maintenance or cleaning procedures.
• Clean, disinfect and decontaminate the system immediately if potentially infectious
material has been spilled.
• Any reagent spills should be washed with a chemical use sodium hypochlorite
solution with 0.5 % active chlorine (e.g. dilution 1:10 of a solution at 5 % active
chlorine) and disposed of as though potentially infectious.
1. Introduction
Page 1-12 LIAISON
®
XS - Instruction for use Rev. H
• All samples, biological reagents and materials used in the assays must be
considered potentially able to transmit infectious agents. They should therefore be
decontaminated and disposed of in accordance with the prevailing regulations and
guidelines of the agencies holding jurisdiction over the laboratory, and the
regulations of each Country.
• Liquid waste must be decontaminated with a chemical use sodium hypochlorite
solution with 0.1 % active chlorine (e.g. dilution 1:50 of a solution at 5 % active
chlorine) for at least half an hour.
• Do not use broken or chipped tubes or bottles.
• Observe the instructions in the package inserts for a correct use of the reagents.
1.6.7 Chemical Hazards
User may be exposed to hazardous chemicals when handling reagents, calibrators and
controls.
Exposure to hazardous chemicals is minimized by following instructions provided in the
assay-specific documentation (such as a package insert) and on product-specific labels,
and product-specific MSDS (Material Safety Data Sheets).
In general, observe the following precautions when handling chemicals:
• Consult MSDS for safe use instructions and precautions.
• Avoid contact with skin and eyes. If contact with material is anticipated, wear
impervious gloves, protective eye wear, and clothing.
• Maintain good housekeeping. Do not eat, drink, or store food and beverages in
areas where chemicals are used.
• Seek medical attention if irritation or signs of toxicity occur after exposure.
1.6.8 Spill clean-up
Clean spills in accordance with established biosafety practices and follow instructions in the
MSDS (Material Safety Data Sheets). In general, safe work practices for cleaning spills
include:
• Wear appropriate personal protective equipment, such as gloves, eye wear and lab
coat.
• Absorb the spill with absorbent material.
• Wipe the area clean with an appropriate disinfectant such as a chemical use
sodium hypochlorite solution with 0.5 % active chlorine (e.g. dilution 1:10 of a
solution at 5 % active chlorine).
Risk of infection!
All internal parts of the system, that are not defined as user interfaces and for which
specific procedures are described, must be treated as being potentially infectious.
Improper handling of infectious parts can cause skin irritations, illnesses and possibly
death.
Disposal of Infectious Waste
Potential infectious material and all parts that may come in contact with potential
infectious material must be disposed according to the local and national provisions,
legislation and laboratory procedures.
1. Introduction
LIAISON
®
XS - Instruction for use Rev. H Page 1-13
1.6.9 Waste handling and disposal
Each facility is responsible for labeling all waste tanks and characterizing its waste stream
to ensure waste is disposed in accordance with the appropriate local regulations.
See the manufacturer's assay-specific documentation (such as a package insert or reagent
application sheet), the product-specific label, or the product-specific MSDS (Material Safety
Data Sheet).
1.6.10 Caution on electromagnetic wave interference
1.6.10.1 Electromagnetic wave interference given by LIAISON
®
XS to other
equipment
The LIAISON
®
XS instrument has been designed and manufactured in compliance to the
applicable EMC standards.
Use the cables attached at the installation for connection between the devices in the
system. The proper use of the specified cables minimizes electromagnetic wave
interference.
Installation and service of the system or changes in the installation may never be performed
by non-authorized persons not approved by DiaSorin Italia S.p.A. Movable multiple plug
sockets different from the one installed by DiaSorin Italia S.p.A. personnel are not allowed.
However, there is no guarantee that the LIAISON
®
XS instrument will not cause
electromagnetic wave interference.
a. When other equipment may be the cause, turn off the power of the equipment and
check the functions of the LIAISON
®
XS instrument.
b. If it is improved, the LIAISON
®
XS instrument probably is the cause.
Misuse of battery
The product may contain an internal lithium manganese dioxide, vanadium pentoxide, or
alkaline battery or rechargeable battery. There is risk of fire and explosions which can lead
to burns if the battery pack is not handled properly.
• Do not attempt to recharge the battery.
• Do not expose to temperatures higher than 60 °C (140 °F).
• Do not disassemble, crush, puncture, short external contacts, or dispose of in fire or
water.
• Spare batteries shall match the values (nominal voltage, nominal current, and type)
specified by the manufacturer.
• Dispose used batteries according to the local and national provisions or legislation.
Disposal of non-contaminated parts
Material out of use (e.g. packaging material) should be properly disposed. Material that
might be used should be kept to avoid future transportation damage.
• Strictly follow the local and national provisions, legislation and laboratory regulations.
• Keep the packaging to allow for safe transportation in case the instrument shall be
shipped at some future date.
1. Introduction
Page 1-14 LIAISON
®
XS - Instruction for use Rev. H
1.6.10.2 Electromagnetic wave interference that may be given to the
LIAISON
®
XS instrument
If the LIAISON
®
XS instrument is used near equipment that generates strong electric and
magnetic field, noises may enter the Instrument to affect the performances and functions.
Use the cables attached at the installation for connection between the devices in the
system. The proper use of the specified cables minimizes electromagnetic wave
interference.
Installation and service of the system or changes in the installation shall be performed only
by authorized persons approved by DiaSorin Italia S.p.A. Movable multiple plug sockets
different from the one installed by DiaSorin Italia S.p.A. personnel are not allowed.
However, there is no guarantee that the LIAISON
®
XS instrument will not be affected by
electromagnetic wave interference.
a. When other equipment may be the cause, turn off the power of the equipment and
check the functions of the LIAISON
®
XS instrument.
b. If they are improved, interference from the equipment is probably the cause.
Try the following to correct the issues.
a. Move the LIAISON
®
XS instrument further away from the equipment that may be
the cause.
b. Connect the power cord of the LIAISON
®
XS instrument to an outlet that is on a
different circuit from the equipment that may be the cause.
c. Check the electromagnetic wave interference does not affect the other equipment,
which is connected with this instrument.
Transient Emissions and Interference Resistance
This instrument meets all requirements described in standard IEC 61326 on transient
emissions and interference resistance.
• This instrument was developed and tested according to CISPR11 Class A. It can cause
radio interference in domestic environments. In this case it may be required to take
action to eliminate such interference.
• Before setup and operation of the instrument, the electromagnetic environment shall be
evaluated.
• Do not use the instrument in the proximity of sources with excessive electromagnetic
radiation (e.g. unshielded, deliberately operated high frequency sources) since they
could interfere with the proper operation of the instrument.
Interference by Mobile Phones
Mobile phones can affect the correct function of the instrument.
• Do not use mobile phones next to a running instrument.
1. Introduction
LIAISON
®
XS - Instruction for use Rev. H Page 1-15
1.6.11 Static magnetic field
Magnets are used in the instrument and clearly identified with labels (see chapter 1.8.19).
Concerning precautionary limits of exposure to magnetic fields, international standards
establish 0.5 mT (5 gauss) as the magnetic flux density threshold level for static magnetic
fields to prevent inadvertent harm to persons with implanted electronic medical devices and
implants containing ferromagnetic material.
The 5 gauss line of all magnets in the instruments are either completely within the
instrument or are exceeding it to an extent which is not expected to have impact on the user
during normal operations.
1.7 Safety residual Risks for User
The aim of this section is to bring to user’s attention the status of residual risks despite the
inherent safe design measures, safeguarding and complementary protective measures
adopted by the Manufacturer to lower the risks to an acceptable level.User must read
carefully this section to understand the residual risks and learn the recommended
instructions to work safely with the LIAISON
®
XS Diagnostic System.If further clarification
should be needed, it is recommended to contact the local DiaSorin Italia S.p.A.
representative.
1.7.1 Definitions
a. “hazard” means a potential source of injury or damage to user’s health;
b. “danger zone” means any zone within and/or around machinery in which a user is
subject to a risk to his/her health or safety;
c. “exposed person” means any user wholly or partially in a danger zone;
d. “user” means the person or persons operating, maintaining and cleaning the
machinery;
e. “risk” means a combination of the probability and the severity of an injury or
damage to health that can arise in a hazardous situation;
f. “guard” means a part of the machinery used specifically to provide protection by
means of a physical barrier;
g. “protective device” means a device (other than a guard) which reduces the risk,
either alone or in conjunction with a guard;
h. “intended use” means the use of machinery in accordance with the information
provided in the instructions for use;
i. “reasonably foreseeable misuse” means the use of machinery in a way not
intended in the instructions for use, but which may result from readily predictable
human behavior.
1. Introduction
Page 1-16 LIAISON
®
XS - Instruction for use Rev. H
1.7.2 Inherent safe design and manufacturing process
The instrument has been designed and manufactured following the applicable regulations
and harmonized standards.
In regards of risk management, the instrument has been designed and manufactured
applying a risk management process, based upon the ISO standard 14971 (Medical
devices – Application of risk management to medical devices). By the application of the
standard, through an iterative process of risk analysis, the manufacturer has:
• Determined the limits of the instrument, which include the intended use and any
reasonably foreseeable misuse;
• Identified the hazards and the associated hazardous situations that can be
generated by the use of the machinery;
• Estimated the risks for hazardous situations, taking into account the severity of the
potential harm (injury or damage to health) and the probability of its occurrence by
the application of an appropriate FMEA (Failure Mode Effect analysis)
methodology;
• Evaluated the risks, with a view of determining whether risk reduction has been
required;
• Reduced the risk for hazardous situations by the identification, implementation and
verification of the effectiveness of appropriate risk control measures.
The above mentioned process will be actively maintained by the Manufacturer until the
retirement of the LIAISON
®
XS Diagnostic System from the market. The Manufacturer has
also established procedures to review post production information in order to ensure the
appropriate safety degree and to maintain the IVD instrument always adequate to the so
called “state of the art” as per, and in compliance with, the European Union Regulation
2017/746/EU related to IVD Medical Devices.
The LIAISON
®
XS Diagnostic System has been designed and constructed so that it is fitted
for its function, and can be operated, adjusted and maintained without putting persons at
risk when these operations are carried out under the conditions foreseen, but also taking
into account any reasonably foreseeable misuse thereof.
The aim of measures taken is to eliminate any risk throughout the foreseeable lifetime of
the machinery including the phases of transport, assembly, dismantling, disabling and
scrapping.
In selecting the most appropriate methods, DiaSorin Italia S.p.A. has applied the following
principles, in the given order:
• to eliminate or to reduce risks as far as possible (inherently safe machinery design
and construction),
• to take the necessary protective measures in relation to risks that cannot be
eliminated,
• to inform users of the residual risks due to any shortcomings of the protective
measures adopted,
• to indicate whether any particular training is required and specify any need to
provide personal protective equipment.
Where possible, the instrument has been designed and constructed to prevent abnormal
use if such use would create a risk.
Where appropriate, the instructions draw the user's attention to ways — if the experience
has shown might occur — in which the machinery should not be used. The instructions have
to be carefully read, paying attention to all warnings, taking into account the way the
instrument has to be operated and which are the abnormal uses forbidden.
1. Introduction
LIAISON
®
XS - Instruction for use Rev. H Page 1-17
The LIAISON
®
XS Diagnostic System is supplied with all the special equipment and
accessories essential to allow safely usage and maintenance. No other tools from the ones
supplied by the Manufacturer must be used; use of unapproved items may endanger user’s
safety and/or health.
1.7.3 Materials and Products
The materials and products of which the instrument is made and the agents and reagents
used on it do not endanger the user’s safety or health, apart from remaining biohazard and
chemical risks and the interference they might cause with electrical and mechanical risks.
In particular, in the areas where biological fluids are used, the instrument has been
designed and constructed to prevent risks due to filling, use, recovery or draining.
1.7.3.1 Waste liquid tank
When user removes the waste liquid tank to empty it, he/she has to disconnect the level
sensor together with the tubing. When user reconnect the waste liquid tank than reconnect
the tubing together with the level sensor.
During a liquid waste tank disconnection, the user has to prevent dripping of infectious
liquid from the tubing waste, when unplugging it. The user has to wear appropriate
protective gloves, lab coat and use paper to dry the tubing. In order to minimize the
possibilities of contamination of cabinet areas, a specific slot of the waste basin shall be
used to position disconnected waste sensors and tubings.
After the tubing and level sensor have been disconnected, the user is asked to carefully
handle the tank to prevent spillage and corner, edge or side shocks.
If an accidental tank shock should occur, before reassembling the tubing and sensor, the
user is asked to accurately check the plastic surface to detect whether any crack or break
occurred. If any crack or break is detected, the tank must not be used and it must be
replaced.
The assessment about residual risks has highlighted that a tank crack generated by a
shock may also not be detected by the user. In this case a basin can prevent the spillage;
because of shape, dimensions and volumes, it does not produce other risks for handling or
mechanical interference.
In no event shall DiaSorin Italia S.p.A. or its affiliates be liable for any damages or losses
incurred in connection with or arising from the use of unapproved items used to operate or
maintain the instrument.
If the waste tank level sensor is not correctly reconnected, the instrument stops using it.
The same occurs if the level sensor is out of order.
The joint connector allows user to manage the insertion/ removal of level sensor and
tubing as a single task. See chapter 5.4.6 for details.
For safe use it is strictly forbidden:
• to alter or modify the level sensor function and/ or use instrument without liquid waste
tank correctly connected to the tubing, apart if a direct drain connection is used for
waste disposal;
• to use cracked or broken tanks.
1. Introduction
Page 1-18 LIAISON
®
XS - Instruction for use Rev. H
1.7.4 Design of instrument to facilitate handling
Where appropriate, according with remaining risks evaluation results, tanks are equipped
with handles in order to facilitate gripping; because of shape, dimensions and volumes, it
does not produce other risks for handling or mechanical interference.
1.7.5 Ergonomics
The LIAISON
®
XS Diagnostic System has been designed taking into account the
ergonomic principles to reduce at minimum discomfort, fatigue, physical and psychological
user’ stress under the intended conditions of use.
1.7.6 Safety and reliability of control systems
Control systems are managed in the instrument control software. A foreseeable fault in the
hardware or in the software of the control system does not lead to hazardous situations.
Software interface of instrument is validated against foreseeable risks: foreseeable errors
in the control system logic do not lead to hazardous situations.
The software is designed to help the user in following the right sequence of operations to
be performed to run the instrument. Reasonably foreseeable human errors during operation
do not lead to hazardous situations. The instrument cannot start un-expectedly because
there are several operations to perform before having it started.
The parameters of the machinery do not change in an uncontrolled way, and may not lead
to hazardous situations: the system set up parameters are not accessible to users.
They are managed by Field Service Engineers only.
If the stop command has already been given, the instrument cannot be prevented from
stopping.
No moving parts of the machinery or pieces held by the instrument can fall or be ejected:
there are no parts that fall as consequence of a stop command.
Where applicable, a tip could be ejected into the appropriate waste solid box as a
consequence of a stop command. It does not lead to risks because it is part of the intended
use of the instrument.
It is strictly forbidden using the instrument with the solid waste bin closed without the EASY
waste box on. A SW counter notifies the user when the solid waste box is full and needs to
be replaced. User is asked to wear gloves when handling the solid waste bin and the EASY
waste box.
1.7.6.1 Main Cover Opening before or during a “moving” status – safe use
The system behaves as follows:
• Whenever the system is in status “initializing” and the main cover will be recognized
as open, then the system stops moving; the consequence will be that, within a few
seconds, the instrument will stop all movements;
• The same would be true if the main cover opening occurs in combination with the
status “maintenance”;
Removing the tube connection from the liquid waste tank or open the solid waste drawer
stops the instrument. The pipettor move in status hold. No start is possible.
1. Introduction
LIAISON
®
XS - Instruction for use Rev. H Page 1-19
• The same would be true if the main cover opening occurs in combination with the
status “running”;
• If the software will not be communicating with the analyzer (e.g. if the PC should be
switched off), then the analyzer will halt itself anyway.
The interlock protective device (i.e the cover sensor) remains fully effective or gives a stop
command also in case is out of order.
1.7.6.2 Emergency stop – safe use
The following conditions may occur and have to be followed after an emergency stop is
given:
• the main switch needs to be turned
• wait few seconds, then push the soft power button
After this the instrument and Panel-PC is turned on and the software can be started.
1.7.7 Failure of the power supply
The interruption, the re-establishment after an interruption or the fluctuation in whatever
manner of the instrument power supply does not lead to dangerous situations.
Particular attention must be paid on the following aspects:
• the instrument does not start unexpectedly: a SW command given by the user is
always necessary to restart movements of the instrument;
• the setting parameters of the instrument do not change in an uncontrolled way in
the case power supply fluctuations or failures should occur, not therefore leading to
hazardous situations; such parameters are not erasable by the electrical power
interruption;
It is strictly forbidden to alter and / or to modify the intended use conditions and functions
of interlocked cover. When open cover condition is ignored, it is strictly forbidden to touch
moving parts while running or getting closed to them with hands, arms, shoulders or face/
head.
No operation must be performed touching moving parts while they are running!
The EMERGENCY STOP can be obtained by cutting energy supply acting on the MAIN
SWITCH.
An emergency stop device would not lower the risk because it would not reduce the
stopping time in comparison with the instrument’s main switch.
The emergency stop function of the main switch is available and operational at any time,
regardless of the operating mode.
1. Introduction
Page 1-20 LIAISON
®
XS - Instruction for use Rev. H
• the instrument is not prevented from stopping if the command has already been
given;
• no moving parts of the instrument or pieces held by it can fall or are ejected in case
of power supply failure;
• automatic or manual stopping of the moving parts, whatever they may be, are
unimpeded;
• the protective devices remain fully effective or give a stop command also in case
they are out of order (please: read also chapter 1.7.6.1).
1.7.8 Protection against mechanical hazards
The durability of the materials used is adequate for the nature of the working environment
foreseen by DiaSorin Italia S.p.A., in particular as regards the phenomena of fatigue, aging,
corrosion and abrasion. To date, there is no evidence of parts showing to be weak.
Insofar as their purpose allows, accessible parts of the instrument have no sharp edges, no
sharp angles and no rough surfaces likely to cause injury.
The moving parts of the instrument are designed and constructed in such a way as to
prevent risks of contact which could lead to accidents or, where risks persist, are fitted with
guards or protective devices or warning signals.
A remaining mechanical hazard is related to moving parts.
Even if the residual mechanical risk is deemed acceptable, the user might be exposed to
biohazard risk in case of minor injury (e.g. cut or scratch).
To prevent mechanical risk, user must not stand close to moving parts of the instrument
when the routine is running. To prevent biohazard risk, user must wear the personal
protective device as per Good Laboratory Practice and according to local regulations.
For safe use it is strictly prohibited:
• to touch moving parts of the instrument while they are running;
• to touch instrument parts, accessories or tools potentially infected without wearing the
personal protective devices;
• to assemble / disassemble tanks tubings without wearing glasses or a protective mask
or visor;
• to handle samples, reagents or any other biological liquid or agent without wearing coat
and gloves;
• to enter the loading bay for sample racks with hand or fingers while the instrument is
running;
• to alter and or to modify fixed or interlocked movable guards;
• to use the instrument in end-user intended use without fixed or interlocked movable
guards.
1. Introduction
LIAISON
®
XS - Instruction for use Rev. H Page 1-21
1.7.9 Protection against electrical hazards
The LIAISON
®
XS Diagnostic System is designed, constructed, equipped and installed in
such a way that all hazards of an electrical nature are or can be prevented. The instrument
is designed and constructed to prevent or limit the build-up of potentially dangerous
electrostatic charges.
Where appropriate, the instrument is installed with additional external switch for residual
current circuit-breakers with over-current protection. Where appropriate it is integrated in
UPS device.
1.7.10 Protection against noise hazards
Instrument is designed and constructed in such a way that risks resulting from the emission
of airborne noise are reduced to the lowest level, taking account of technical progress and
the availability of means of reducing noise, in particular at source. For technical data
regarding noise emission, refer to chapter 9.7.
1.7.11 Protection against electrostatic discharge
National rules and local regulations for the safe electrical operations of the system must
be strictly observed.
The instrument is not designed and constructed to be operated in a potentially explosive
atmosphere. The instrument must not be installed and used in a laboratory with potentially
explosive atmosphere.
End user is responsible to assess that such requirement is respected before allowing
DiaSorin Italia S.p.A. or its affiliates to install the instrument.
For safe use it is strictly prohibited:
• To interrupt the electrical grounding contacts;
• To add any other device to the multi plug supplied with the instrument (if available) with
the exception of those installed by DiaSorin Italia S.p.A. authorized representatives;
• To damage connecting cables or not replacing them if damaged;
• To place objects on the connecting cables;
• To leave connecting cables in accessible or drivable areas where they can become
additional risk;
• To not immediately disconnect the instrument from the main supply, if a safe usage is
no longer possible;
• To cover the switches or have them inaccessible;
• To use the instrument if any switch or controls device is damaged.
The A-weighted emission sound pressure level at workstations does not exceed 70 dB(A).
Electrostatic discharge
Electronic components can be damaged or destroyed by electrostatic discharge.
Use protective measures against electrostatic discharge.
1. Introduction
Page 1-22 LIAISON
®
XS - Instruction for use Rev. H
1.8 Instrument Labeling and Safety Labels
This section provides information on the instrument labeling, with particular focus on the
safety labels.
Safety labels are used on the LIAISON
®
XS system and in the documentation to identify
potentially dangerous conditions. Before starting to use the instrument, user has to identify
these labels and understand the type and degree of potential hazard.
1.8.1 Instrument Serial Label
Instrument Serial Label is placed on the right side of the instrument back panel
Figure 1–1: Instrument label positioning
Missing Warnings
Missing or unreadable warning labels or type labels can result in non-identified dangers.
This can cause serious personal injuries and material damages.
• Check the system on missing or unreadable warning labels and type labels.
• Missing or unreadable warning labels or type labels must be replaced.
1. Introduction
LIAISON
®
XS - Instruction for use Rev. H Page 1-23
1.8.2 Fuse label
Fuse label is positioned on:
Right side of the instrument, above the main switch
Figure 1–2: Fuse label, right side of instrument
1.8.3 Main Switch label
Main Switch label is positioned on:
Right side of the instrument, to the left of main switch
Figure 1–3: Main Switch label, right side of instrument
1. Introduction
Page 1-24 LIAISON
®
XS - Instruction for use Rev. H
1.8.4 LAN label
LAN label is positioned on:
Right side of the instrument, above the LAN port
Figure 1–4: LAN label, right side of the instrument
1.8.5 USB label
USB label is positioned on:
Right side of the instrument, above the USB ports
Figure 1–5: USB label, right side of the instrument
1. Introduction
LIAISON
®
XS - Instruction for use Rev. H Page 1-25
1.8.6 Pull Power plug label
Electrical hazard label: Pull power plug is positioned on:
• Right side of the instrument, left of the main switch behind the right cover
Figure 1–6: Pull power plug label, right side of instrument
1. Introduction
Page 1-26 LIAISON
®
XS - Instruction for use Rev. H
1.8.7 Laser Label
Figure 1–7: Sample Module, laser label
• Sample flap
Figure 1–8: Sample flap, laser label - First Type (A), Second Type (B)
Laser labels are positioned on:
• Sample module, front view
1. Introduction
LIAISON
®
XS - Instruction for use Rev. H Page 1-27
• External barcode reader
Figure 1–9: Barcode reader, laser label
1.8.8 Pipettor label
Figure 1–10: Left pipettor arm
Moving parts labels, together with hot surface label, are positioned on:
• Left pipettor arm
• Right pipettor arm
1. Introduction
LIAISON
®
XS - Instruction for use Rev. H Page 1-29
1.8.10 Liquid Waste label
Figure 1–13: Liquid Waste tank label
1.8.11 Liquid Waste basin labels
Figure 1–14: Liquid Waste basin labels
A biohazard symbol is placed on the front side the liquid waste tank (Figure 1–13),
together with a label indicating the content. These symbols indicate the users the
presence of contaminated liquids inside.
A biohazard symbol is placed on both side of the liquid waste basin (Figure 1–14),
together with labels to don’t step on the basin. These symbols indicate the users the
presence of contaminated liquids inside.
1. Introduction
Page 1-30 LIAISON
®
XS - Instruction for use Rev. H
1.8.12 System liquid label
Figure 1–15: System Liquid tank label
1.8.13 Wash Buffer label
Figure 1–16: Wash Buffer tank label
A symbol, indicating the presence of system liquid inside, is placed on top of the System
liquid tank (Figure 1–15).
For the preparation of the System Liquid solution, refer to the Instruction for Use (IFU)
provided with the System Liquid bottles.
A symbol, indicating the presence of wash buffer solution inside, is placed on top of the
Wash Buffer tank (Figure 1–16).
For the preparation of the wash solution, refer to the Instruction for Use (IFU) provided
with the EASY Wash Buffer bottles.
1. Introduction
LIAISON
®
XS - Instruction for use Rev. H Page 1-31
1.8.14 Cleaning Solution label
Figure 1–17: Cleaning Solution tank label
1.8.15 DI Water label
Figure 1–18: DI Water tank label
1.8.16 Bulk fluid label
Figure 1–19: Bulk fluid area label
A symbol, indicating the presence of cleaning agent inside, is placed on top of the
Cleaning Solution tank (Figure 1–17).
A symbol, indicating the presence of DI Water inside, is placed on top of the DI Water
tank (Figure 1–18).
Caution label is positioned on bulk fluid area.
1. Introduction
Page 1-32 LIAISON
®
XS - Instruction for use Rev. H
1.8.17 Top cover labels
Figure 1–20: Biohazard label, inside left and right top cover
A bio-hazard label informs the user about the possible dangers associated to the contact
with the inner parts of the instrument, are placed on the internal face of the top covers
(Figure 1–20).
Risk of infection!
As indicated by the labels applied to the interior face of the left top cover, all internal parts
of the system, that are not defined as user interfaces and for which specific procedures
are described, must be treated as being potentially infectious. For this reason:
• Open the left top cover only if strictly necessary.
• Wear appropriate protection devices (disposable gloves, lab coat, eye protection)
before coming into contact with the internal parts of the system.
In order to prevent possible hand crushings during the opening/closure of the top covers,
two specific warning labels are placed on the front cover bar, respectively under the left
(Figure 1–21) and the right (Figure 1–22) top covers.
Figure 1–21: “Danger of crushing hands”
left label
Figure 1–22: “Danger of crushing hands”
right label
1. Introduction
LIAISON
®
XS - Instruction for use Rev. H Page 1-33
1.8.18 Flap labels
Figure 1–23: Flap labels - Sample Area - First Type (A), Second Type (B)
Figure 1–24: Flap labels - Reagent Area
No objects shall be put on the flaps of reagent area, sample area and starter area when
they are opened. In order to avoid possible misunderstandings of users, a specific label is
applied to the flaps (Figure 1–23, Figure 1–24 and Figure 1–25).
Bio-hazard labels are also applied to the sample and reagent flaps, informing the user to
pay attention to the possible presence of spills of infectious liquids caused by sample or
reagent improper handling.
1. Introduction
LIAISON
®
XS - Instruction for use Rev. H Page 1-35
1.8.19 Magnet Label
Magnet labels are positioned on:
• Washer module, on top
• System Liquid tank
• Wash Buffer tank
• Cleaning Solution tank
• DI Water tank
• Instrument rear view
• Front cover, re-suspension tool
Figure 1–26: Washer Module, magnet label
Figure 1–27: System Liquid tank, magnet label
1. Introduction
Page 1-36 LIAISON
®
XS - Instruction for use Rev. H
Figure 1–28: Wash Buffer tank, magnet label
Figure 1–29: Cleaning Solution tank, magnet label
Figure 1–30: DI Water tank, magnet label
1. Introduction
LIAISON
®
XS - Instruction for use Rev. H Page 1-37
Figure 1–31: Instrument rear side view
Figure 1–32: Front cover, rear side view
1. Introduction
Page 1-38 LIAISON
®
XS - Instruction for use Rev. H
1.8.20 Shockwatch, Tiltwatch and Temperature label
Shockwatch, Tiltwatch and Temperature label: is positioned on:
• Rear side of the instrument
Figure 1–33: Rear side, Shockwatch, Tiltwatch and Temperature label
1. Introduction
LIAISON
®
XS - Instruction for use Rev. H Page 1-39
1.9 Operational Precautions and limitations
This section describes the operational requirements, precautions, and limitations to ensure
user safety and accurate assay results.
User must follow these requirements to help ensure proper system performance.
Not following the requirements and precautions provided can impact the system and assay
performance and may cause damage to the system or adversely affect assay results.
1.9.1 General requirements
• Ensure the system is out of direct sunlight, heat and drafts, and away from any heat
generating device. Exposure to heat and drafts can interfere with the ability of the
system to maintain an operating temperature that is within the acceptable range.
• Maintain the required space on all sides of the system. For more information about
space requirements, see chapter 9.5. This space buffer is essential for:
○ Accurate temperature control of the system;
○ Adequate cooling of electrical components;
○ Easy access for disconnecting the power cord when required;
○ Easy access for maintenance.
1.9.2 Forbidden foreseeable misuse
The following list includes (but is not exhaustive) a set of forbidden foreseeable misuses
identified by the Manufacturer. The user must carefully read below notes and follow the
indicated safe way to operate to avoid risk of harm.
• Troubleshooting operations to resolve cuvette jamming performed while moving
parts are active. Intended use: operation is allowed when moving parts are inactive.
• Introduce body parts in the hazard area while the instrument is active with moving
parts. Intended use: any needed operation is allowed when moving parts are
inactive.
• Operate the instrument without the EASY waste and the solid waste bin onboard
unless during EASY waste box replacement. Intended use: EASY waste box and
its bin must be onboard unless during EASY waste box replacement.
• Operate the instrument with no liquid waste tank connected. Intended use: a liquid
waste tank must always be connected before operating. This restriction is not
applicable if waste tubing is directly connected to a laboratory drain.
Danger due to Overheating
Improper positioning (installation or operation) of the system or improper environment
may cause fire or serious system damage in case of overheating.
• Leave the system power on continuously unless instructed otherwise in a maintenance
or troubleshooting procedure, or unless an emergency situation occurs.
• Perform maintenance procedures as recommended in chapter 8.
• Do not attempt any maintenance that is not specified in the documentation provided by
DiaSorin Italia S.p.A.
• In case of user injury, keep the potential contaminant agent for a subsequent analysis.
1. Introduction
Page 1-40 LIAISON
®
XS - Instruction for use Rev. H
1.9.3 System operation
1.9.3.1 Precautions and Requirements before operation
Before beginning to operate the system, the user has to:
• Read this manual thoroughly to understand full functionality of the system and
associated hazards.
• Read the sections of the reagent manufacturer's assay-specific documentation that
are associated with:
○ Warnings and precautions;
○ Safety precautions.
• Verify that the solid waste bin is equipped with the appropriate EASY Waste box.
• Verify that the liquid waste tank is not full and correctly positioned.
1.9.3.2 Precautions during operation
• Keep all drawers and covers closed if not unless instructed otherwise in a described
procedure.
• Do not disconnect any electrical connection while the power is on.
• Respond to system warnings during processing.
• Dispose of all waste material according to local regulations.
• Remove all samples and integrals from the system in case of an emergency stop.
1.9.4 Handling of reagents and consumables
See the manufacturer's assay-specific documentation (such as a package insert), the
specific product label, the appendixes of the present manual or the Material Safety Data
Sheet (MSDS) for detailed information, including hazard symbols.
1.9.5 Handling of specimens
Carefully read the reagent manufacturer's assay-specific documentation and the present
manual for information about specimen collection, preparation, and storage.
Consider all system surfaces or components that have been in contact with human-sourced
materials as potentially infectious.
1. Introduction
LIAISON
®
XS - Instruction for use Rev. H Page 1-41
1.9.6 Limitation of result interpretation
Any assay result supplied by the instrument does not aim to be released as medical advice
or service without approval by authorized medical personnel.
Assay results must be used with other clinical data such as patient symptoms, other test
results, patient history, clinical data, information available from clinical evaluation, and other
diagnostic procedures.
The LIAISON
®
XS has been validated for its intended use only. However, errors can occur
due to potential operator errors and LIAISON
®
XS System technology limitations. If assay
results are inconsistent with clinical evidence, additional testing is suggested to confirm the
result.
1.10 Installation of the System
Clot Detection System
Not withstanding the instrument is equipped with a clot detection system, the user is not
authorized by DiaSorin Italia S.p.A. to load consciously on the instrument sample tubes
containing clots. Any default of the system related to a relevant unappropriate use is in the
sole responsibility of the user.
Installation
Please note that the LIAISON
®
XS system may only be installed by authorized service
personnel.
The Analyzer is not designed and constructed to be operated in a potentially explosive
atmosphere. The Analyzer must not be installed and used in a laboratory with potentially
explosive atmosphere.
Customer is responsible to assess that the above requirement is respected before
allowing DiaSorin Italia S.p.A. or its affiliates installing the Analyzer.
Note Technical Data
See chapter “Technical Data” (chapter 9) for power requirements, computer and
connections, installation dimensions, weight and environmental conditions.
After the installation, the user of the LIAISON
®
XS system receives an installation
qualification which documents the proper installation of the LIAISON
®
XS system.
1. Introduction
Page 1-42 LIAISON
®
XS - Instruction for use Rev. H
1.11 Removal of the System
If the system must be shipped to a new location, user shall contact the local DiaSorin field
service representative for assistance.
Removal
The removal of the LIAISON
®
XS system must be performed by authorized service
personnel.
Reinstallation
If the LIAISON
®
XS system moves within the plant, the authorized service personnel must
perform a complete reinstallation. If this reinstallation is omitted, this can cause damage of
the system or irregular pipetting performance.
2. PC security measure
LIAISON
®
XS - Instruction for use Rev. H Page 2-1
2 PC security measure
2.1 Introduction
LIAISON
®
XS software is intended to be used in a controlled environment. Access is
allowed only to trained and authorized users.
Nevertheless, usage of the system may be subject to risk of unauthorized access, leading
to possible data loss, corruption or unauthorized distribution.
Furthermore, updates to the software modules provided with the system (e.g. Operating
System) must be distributed under controlled process, to ensure that the system still
behaves according to its intended use after the update.
This chapter describes the policy followed by DiaSorin and partners regarding how software
environment is kept secure on systems installed in end-user environment.
2.2 Unauthorized local access
2.2.1 Potential issues
Usage of the system is meant only for trained and authorized users, who are supposed to
follow the intended use of the system.
Unauthorized users could access or damage a computer system without the owner's
informed consent. Consequences may be software and data loss, corruption or
unauthorized distribution.
2.2.2 Protection measures
Access to the LIAISON
®
XS software is based on an access rights structure that allows
system operation only to authorized users:
• operating the system, including access to any data, is only possible when typing a
user identifier (made of “user name” and “password”), that is unique for each end-
user;
• “user name” is unique and cannot be re-assigned;
• both “user name” and “password” must be at least 8 characters long;
• for each “user name”, a “password duration” can be set; within the time frame
based on “password duration”, the system will force the user to change the
“password”;
• each user can change his/her own password;
• since, during installation of the system, for every user one default “password” will
be inserted. it will be in the care of DiaSorin and partners personnel to inform the
end-users to modify her/his password at the first usage;
• it’s possible to define a “session expiration time”, i.e. a time interval after which the
system logs-off the current user;
• end-users are logged into Operating System with a restricted account;
• end-users have no means to overcome the LIAISON
®
XS software application,
i.e. they have no access to the Operating System and other applications.
2. PC security measure
Page 2-2 LIAISON
®
XS - Instruction for use Rev. H
2.3 Malware
2.3.1 Potential issues
Usage of LIAISON
®
XS computer could lead to voluntary or involuntary introduction of
malicious software, like viruses, worms, spyware. This malicious software (also called
malware) is designed to infiltrate, damage or steal information from a computer system
without the owner's informed consent.
Consequences may be software and data loss, corruption or unauthorized distribution.
The introduction of such malicious software may occur:
• via network;
• via a local USB device.
2.3.2 Protection measures
The state-of-art, widespread approach is to provide network intrusion protection, with
specific equipment and/or software, and device software protection, with specific anti-
malware products. This approach does not looks adequate for the LIAISON
®
XS computer
for several reasons:
• any network firewall should be installed by network administrators and/or skilled
technical staff who, in this scenario, are end-users in regards to DiaSorin, therefore
DiaSorin has no control on the firewall solution in terms of adequacy;
• any antimalware must be kept up-to-date to be efficient, therefore automatic
frequent updates are necessary; the only mode to guarantee this is to connect the
computer to an update source over the network or the internet but:
○ it cannot be ensured that all computers will be connected and, also for those
connected, connection cannot be guaranteed upfront, while a malware can be
introduced anytime, even without network connection;
○ furthermore, continuous automatic updating of the anti-malware product implies
that the system configuration is frequently updated while DiaSorin could not
guarantee a continuous validation update in a constant changing configuration;
for example, an antivirus could unexpectedly recognize as malware and delete
files that are necessary part of the validated environment, with the consequence
of potential software malfunctioning.
For all these reasons, an alternative integrated approach has been chosen:
• all the Operating System ports, not strictly required by the validated applications,
will be blocked and/or disabled on the computer;
• the Operating System integrated firewall will be activated and configured such as
any remote access to the system is denied (except specific ports needed for
remote access authorized by DiaSorin);
• AutoPlay feature for all USB storage devices will be disabled on the Operating
System;
• it is prohibited to install any external removable media USB device (CD/DVD-Rom
or Floppy Disk);
• introducing infected files from USB devices is prevented by design, as end-users
will have access, on the computer, to the sole features allowed by the
LIAISON
®
XS, i.e. access to the Operating System features is inhibited, and
LIAISON
®
XS will only allow to import files with specific proprietary extensions,
disregarding any file with different extension;
2. PC security measure
LIAISON
®
XS - Instruction for use Rev. H Page 2-3
• system boot order starts from the Operating System disk;
• as additional protection, a specific and defined on-demand malware scan tool,
relying on heuristic detection methods, is installed on LIAISON
®
XS. No other anti-
malware product can be installed on LIAISON
®
XS.
2.4 Unauthorized network access
2.4.1 Potential issues
A LIAISON
®
XS computer connected to a network could be accessed by unauthorized
individuals, causing unpredictable effects on installed software and data. Consequences
may be software and data loss, corruption or unauthorized distribution.
2.4.2 Protection measures
A software firewall is an application which controls network traffic to and from a computer,
allowing or denying communication based on a security policy.
The Operating System integrated firewall is activated and configured to make sure inbound
network access is denied.
Theoretically, only computers connected to a network require a personal firewall, but for the
sake of uniformity all computers provided with Liaison XS will be protected by the Operating
System personal firewall.
2.5 System update
2.5.1 Potential issues
Operating System and other software modules installed on LIAISON
®
XS computer may
require to be updated, from time to time, in order to fix specific issues, in particular security
vulnerabilities.
2.5.2 Protection measures
Continuous change to software modules leads to a technical risk: the more changes are
introduced, and the more frequent they are, the more risks would accumulate in these
regards. The described protection measures against external intrusions are considered
safe enough to mitigate known risks and risks introduced by new vulnerabilities on the
LIAISON
®
XS computer.
For these reasons, the Operating System and other software modules installed on
LIAISON
®
XS computer will be updated only if a change is due to known technical reasons.
2. PC security measure
Page 2-4 LIAISON
®
XS - Instruction for use Rev. H
2.6 Local/network printing
2.6.1 Potential issues
There are two possible printing device types that can be used (only one per system):
• a local printer;
• a network printer.
Usage of a local printer, installed by DiaSorin on LIAISON
®
XS systems as “default printer”,
requires installing printer drivers that could affect the system with consequences like
software and data loss.
Usage of a network printer, configured by DiaSorin on LIAISON
®
XS systems as “default
printer”, requires to install printer drivers, that may be not available for the LIAISON
®
XS
computer, or to rely on Operating System printing service, that could affect the system with
consequences like software and data loss.
2.6.2 Protection measures
Local printer models, installed by DiaSorin on LIAISON
®
XS systems, are validated against
their intended use. No printers that did not pass the validation test will be installed on
LIAISON
®
XS systems.
Usage of a network printer will be supported:
• By installing printer drivers, provided that a printer model validation is carried out
○ through the definition of a predefined set of “standard printer models”
○ via dedicated validation for any additional printer model
or relying on the Operating System printing service, without installing printer drivers.
2.7 Desktop Sharing
2.7.1 Potential issues
LIAISON
®
XS systems may be accessed by DiaSorin support personnel with the purpose
of troubleshooting, customer support, and software update. This will be managed through
a dedicated application that requires software installation on both Liaison XS computer and
support personnel computers.
Remote access may be established through an internet based network connection.
Availability of a network connection may vary depending on countries and specific user
technical infrastructure.
Presence of such application could lead to systems being remotely accessed by
unauthorized subjects, causing unpredictable effects on installed software and data.
These situations could lead to consequences such as software and data loss, corruption or
unauthorized distribution.
2. PC security measure
LIAISON
®
XS - Instruction for use Rev. H Page 2-5
2.7.2 Protection measures
Remote access connection will be established on a secure communication channel,
protected by encryption and authentication to guarantee confidentiality and integrity of data
transmission.
DiaSorin certifies that only authorized personnel are allowed to perform remote connection.
No remote connection session can be initiated without the explicit allowance of an operator
in front of the system who is able, at any time, to interrupt the same session.
2.8 IoT connection
2.8.1 Potential issues
LIAISON
®
XS systems may send to a dedicated cloud system telemetry data for the
purpose of troubleshooting, customer support.
Furthermore the IoT connection can be used to retrieve updated manuals, assay-relevant
files.
This will be managed through a dedicated communication channel that requires activation
on the Liaison XS software and the availability of a network connection with internet access.
The availability of a network connection may vary depending on countries and specific user
technical infrastructure.
Opening of such communication channel could lead to system being accessed by
unauthorized actors, causing unpredictable effects on installed software and data.
These situations could lead to consequences such as software and data loss, corruption or
unauthorized distribution.
2.8.2 Protection measures
The IoT connection will be established on a secure communication channel, protected by
encryption to guarantee confidentiality and integrity of data transmission.
There’s no direct access of any personnel to the systems.
DiaSorin adopts a risk based approach to implement adequate technical measures aimed
to reduce the risk of the described potential issues.
2.9 Privacy
2.9.1 Potential issues
LIAISON
®
XS produces analytical results that refer to the health condition of patients.
Therefore, a potential risk of unauthorized disclosure of sensitive patient data may exist in
regards to:
a. DiaSorin personnel (directly or indirectly involved in technical activities on the
laboratory systems)
b. DiaSorin partners personnel (directly or indirectly involved in technical activities on
the laboratory systems)
c. DiaSorin suppliers personnel (indirectly involved in technical activities on the
laboratory systems).
2. PC security measure
Page 2-6 LIAISON
®
XS - Instruction for use Rev. H
Patient health data could be potentially available to the above mentioned subjects in the
following situations:
1. during a technical intervention on laboratory systems, personnel of type “a” or “b”
may need to access the LIAISON
®
XS software that may contain patient health
data, therefore check such data on the screen or print data as hard copy;
2. personnel of type “a”, “b” or “c” could retrieve patient health data as part of data
exchanged in electronic or paper format, as part of technical troubleshooting or
maintenance activities that involve such personnel.
Furthermore, users different from above listed types could get in contact with patient health
data.
Specific country regulations may require different means to address the listed potential
issues.
2.9.2 Protection measures
The following measures are adopted in order to make the system compatible with the
known regulatory requirements. Measures already listed and described in the present
chapter that are in place to protect the patient health data are not repeated here.
1. Both patient health data and demographics are encrypted;
2. No patient demographic data is exchanged through remote access or IoT;
3. It is possible to manually perform a complete back-up of patient health data;
4. It is possible to schedule automated back-up of patient health data;
5. Sample identifier (SID) as well as patient identifier (PID), are conceived as an
anonymous sequence of alphanumeric characters, that end-users may use in
combination with their laboratory system, in which all patient information are
maintained, and particularly patient demographics;
6. The system can perform all analysis without the need to insert patient
demographics; as such it is recommended that demographic insertion is avoided
both as manual input and LIS transmission;
7. The system allows to fill (either manually or by receiving such information from
the LIS system) the fields “name” and “last name” present in the patient
information,
8. In case the fields “name” and “last name” (patient demographics) are filled:
a. access to such data will be restricted, on the system, to specific users, for whom
the laboratory responsible people will request activation during system set up;
b. such measure regards the on screen display and the printed copies of such
information, either directly from the Personal Computer connected to the system
or from any other Personal Computer on which LIAISON
®
XS software is
installed and where data bases are loaded after exporting from the original
Personal Computer;
c. such measure covers both the direct visualization of information (e.g. on screen
display of health data in combination with demographics) and indirect search
(e.g. the possibility to go back from health data to the SID and from the SID to
the personal data);
d. therefore, not explicitly authorized users will not have the rights to get access to
patient demographics, not even in case the user provided the database
containing patient demographics.
2. PC security measure
LIAISON
®
XS - Instruction for use Rev. H Page 2-7
Regarding end-users responsibilities, where required by local regulations, the end-user is
responsible for the following behavior: on LIAISON
®
XS SID and PID must not refer to the
patient; such traceability shall be kept on the laboratory tracing systems.
In regards to the responsibilities of DiaSorin, where required by local regulations, DiaSorin
responsibility is configured as follows:
a. in case of evidence of a LIAISON
®
XS being operated outside requirements of
local applicable privacy regulation, DiaSorin will solicit compliance;
b. DiaSorin is not liable for improper use of data generated through the LIAISON
®
XS
once such data is outside of the boundaries of the system itself, i.e. after data has
been written, printed, or sent in electronic format to other laboratory systems.
DiaSorin adopts a risk based approach to implement adequate technical measures aimed
to reduce the risk of the described potential issues.
2.10 Security Requirements for Operating Environment
The Operating Environment is defined as the complex of physical and logical/IT
environment interacting with the LIAISON
®
XS during intended operating conditions.
To integrate the LIAISON
®
XS in the Operating Environment according to security
standards and best practices, the Operating Environment shall comply with the following:
1. Applicable data privacy regulations;
2. Adequate security controls including network traffic;
3. Any patch management process shall prevent interoperability/compatibility
issues with the LIAISON
®
XS.
2. PC security measure
Page 2-8 LIAISON
®
XS - Instruction for use Rev. H
3. Measuring principle of the LIAISON
®
XS immunoassay
LIAISON
®
XS - Instruction for use Rev. H Page 3-1
3 Measuring principle of the
LIAISON
®
XS
immunoassay
3.1 Explanations for Steps of Assays
Assays (also defined as “tests”) that run on the LIAISON
®
XS are divided into major
categories:
• 1-step assays
• 2-step assays
• 3-step assays
The numbered steps refer to the required amount of incubation sequences for a test.
An incubation sequence is described as the amount of times a sample must enter the
incubator during the run.
These categories are described in detail below.
3.1.1 Test Procedure 1-Step Assay
A 1-step assay refers to a test or assay that has:
• 1 incubation sequence (the time of
incubation may range depending on the
assay).
• 1 wash sequence (the amount of
washing for this sequence is assay
dependent).
Most assays that are 1-step have an incubation
time of 10 minutes. The figure below is only an
example. Pipetting sequences are also assay
dependent.
Figure 3–1: Example of test procedure “1-step assay”
3. Measuring principle of the LIAISON
®
XS immunoassay
Page 3-2 LIAISON
®
XS - Instruction for use Rev. H
3.1.2 Test Procedure 2-Step Assay
A 2-step assay refers to an assay that has:
• 2 incubation sequences (the time of
incubation may range depending on
the assay).
• 1 or 2 wash sequences (the amount
of washing for each sequence is
assay dependent).
Most assays that are 2-step have an
incubation time of 10 minutes each.
The figure below is only an example.
Pipetting sequences are also assay
dependent.
Figure 3–2: Examples of test procedure “2-step assay”
3.1.3 Test Procedure 3-Step Assay
A 3-step assay refers to an assay that has:
• 3 incubation sequences (the time of incubation may range depending on the
assay).
• 1 to 3 wash sequences (the amount of washing for each sequence is assay
dependent).
3. Measuring principle of the LIAISON
®
XS immunoassay
LIAISON
®
XS - Instruction for use Rev. H Page 3-3
3.2 Measuring Principle
• After the last wash cycle has been completed, the cuvette is transported into the
Reader.
• When the cuvette reaches the position under the first injection head, starter reagent
1 will be injected.
• The cuvette is transported in the position under the second injection head and the
starter reagent 2 will be injected to start the chemiluminescence reaction.
• In this way the pump delay time between the starter 1 and the starter 2 is 2.50 sec
minimum.
• The measuring signal is obtained and integrated over the measuring period
(3.0 sec for most assays).
Figure 3–3: LIAISON
®
XS kinetic curve
3.3 Measuring Function Description
• The chemically emitted light is measured by a selected highsensitive, low-noise
photomultiplier [PMT]. The linear measuring range of the photomultiplier is 300 –
650 nm. The light peak of the chemiluminescence is emitted at a wavelength of
420 nm.
• The PMT is operating as an ultra-fast photon counter. The pulses are amplified by a
rapid electronic amplifier. A circuit, which suppresses the PMT signal-noise is also
implemented in the PMT box.
• Not the number of counts, but the Relative Light Units [RLU] are used as units of
the measurement for the raw data.
3. Measuring principle of the LIAISON
®
XS immunoassay
Page 3-4 LIAISON
®
XS - Instruction for use Rev. H
3.4 Calibration (quantitative)
Data reduction is performed using a
master curve with 2-point
recalibration.
The starting point of data reduction is
the master curve, stored in the
RFTag of each integral of the
assays.
To compensate for differences
between reagent lots, different
analyzers and environmental
conditions, assay calibration must be
run and validated according to the
indications reported in the assay
Instructions for Use (indications may
vary per assays).
The measuring signals of the
calibrators allow the shift of all
master curve points to a working
curve, corresponding with the actual
conditions during measurement.
See the following example.
Figure 3–4: Calibration concept: example
Brief description: • The master curve is generally defined with 10 master curve base points.
• Two calibrators with defined concentration values are measured. These measured
signals (RLU) are compared with the master curve signal of the corresponding
calibrator concentrations.
• The relative difference between the measured RLU and the master RLU of the
calibrators is calculated and a linear extrapolation is performed between the
recalculated RLU (Y-axis) and the logarithmic (Log) concentrations (X-axis).
• Based on appropriate compensation factors, a re-adjustment of the master curve points
is made in order to achieve, by a “cubic spline function”, the working curve.
Wrong Results!
For continuous safety of the diagnostic results, quality control measures are to be
maintained, such as routine controls or calibration issues, which are defined in this
Operating Instruction.
• Safe and intended function of the LIAISON
®
XS Diagnostic System can only be
expected with the use of LIAISON
®
XS controls approved by
DiaSorin Italia S.p.A.
• Observe instructions in IFU of the reagents for Qualiy Control of the assay.
3. Measuring principle of the LIAISON
®
XS immunoassay
LIAISON
®
XS - Instruction for use Rev. H Page 3-5
3.5 Calibration (qualitative)
The calculation of a reference level, the cut off (CO), is performed as a linear combination
of terms, dependent upon system base signal and calibrators’ RLU. Formula applied is the
following:
Analytical result is reported as index, the ratio of the unknown sample signal RLU
sample
vs
the CO:
Two kinds of QCal are possible, depending upon the number of calibrators:
• in one point qualitative, only calibrator 1 is present: coefficients given are a and c
only;
• in two points qualitative, both calibrator 1 and 2 are present: all three coefficients a,
b and c are given.
Validation of calibration is possible if results scored by the calibrator(s) lie within the related
acceptance ranges.
After validation, the cut off is then calculated from the formula above.
3. Measuring principle of the LIAISON
®
XS immunoassay
Page 3-6 LIAISON
®
XS - Instruction for use Rev. H
4. System description
LIAISON
®
XS - Instruction for use Rev. H Page 4-1
4 System description
4.1 Overview
4.1.1 Materials required but not provided
In order to perform immunoassays, the following materials are needed beside specific
assay kits:
• LIAISON
®
Cuvettes on Tray (code X0053).
• LIAISON
®
Disposable Tips (code X0055).
• LIAISON
®
EASY Starter Kit (code 319300).
• LIAISON
®
EASY Wash Buffer (code 319301).
• LIAISON
®
EASY System Liquid (code 319302).
• LIAISON
®
EASY Waste (code X0054).
4. System description
Page 4-2 LIAISON
®
XS - Instruction for use Rev. H
4.1.2 LIAISON
®
XS System
Figure 4–1: LIAISON
®
XS system
Table 4–1: LIAISON
®
XS System
Opening the cover during system operations may result in operation interruption and no
reported results.
No. Description
1) Left side cover
2) Left top cover
3) Right top cover
4) Right side cover
5) Front Module (starter reagents, drawer for disposable cuvette and tip
trays, loading bays for samples, solid waste bin, reagents area and
resuspension tool)
6) Bulk fluid door for Wash Buffer and System Liquid tanks
7) Panel-PC with touch screen
4. System description
LIAISON
®
XS - Instruction for use Rev. H Page 4-3
4.1.3 Outer front view
Figure 4–2: LIAISON
®
XS flaps and drawers
Table 4–2: Instrument overview
No. Description
1) 3 liter Wash Buffer
2) 5 liter System Liquid
3) Top Cover Right
4) Top Cover Left
5) Panel-PC with touch screen
6) Starters reagent flap
7) Disposal tips and cuvettes drawer
8) Sample bay flap
9) Solid waste Bin
10) Status Light
11) Reagent module flap
12) Integrated re-suspension tool
4. System description
Page 4-4 LIAISON
®
XS - Instruction for use Rev. H
4.1.4 Left inside view
Figure 4–3: Instrument inside left side view
Table 4–3: Instrument inside left side view
No. Description
1) Pipettor left arm (Sample & cuvette gripper)
2) Washer
3) Reader
4) Incubator
5) Disposable tips area
6) Cuvettes trays area
7) Samples area
4. System description
LIAISON
®
XS - Instruction for use Rev. H Page 4-5
4.1.5 Right inside view
Figure 4–4: Instrument right inside view
Table 4–4: Instrument right inside view
No. Description
1) Pipettor right arm (SPOLV)
2) Reagent area module
3) Wash station
4) Wash station splash containment
4. System description
Page 4-6 LIAISON
®
XS - Instruction for use Rev. H
4.1.6 Left side view
Figure 4–5: Left side view
Table 4–5: Left side view
The Liquid Waste Tank shall be located below the instrument or on the same stand/table
where the instrument is placed.
No. Description
1) Liquid waste outlet
2) Liquid waste tubing and sensor
3) Liquid Waste Tank
4) Liquid Waste Basin
Wrong placement of the Waste Tank
Too high installation of the Liquid Waste Tank can lead to a liquid drawback!
• It is preferred to place the waste container below the instrument.
4. System description
LIAISON
®
XS - Instruction for use Rev. H Page 4-7
4.1.7 Right side view
Figure 4–6: Right side view
Table 4–6: Right side view
No. Description
1) Main switch
2) LAN connector
3) USB connectors
4) Soft power button
4. System description
Page 4-8 LIAISON
®
XS - Instruction for use Rev. H
4.1.8 Glossary
Ancillary (reagents) Anything that can be introduced by operator into Ancillary Area
rack, including external reagents for some kits and Light Check.
Barcode Reader Assembly to read the sample barcode.
BGW Test to check quality of instrument washing.
Control Rack 8 positions module to host some types of control bottles and
external calibrators.
Cuvette Single cavity plastic module, in which immunometrical reaction
can take place.
CV% Statistical variable that shows dispersion rate of measurements.
EASY Waste Carton disposable box to increase safety during waste disposal.
Gripper Mechanism to handle cuvettes loading from trays, exchange
cuvettes between incubator and washer and move cuvettes from
washer to reader.
Incubator The incubator offers 32 cuvette positions in the outer ring and
25 cuvette positions in the inner ring in which cuvettes are
incubated and pipetted.
Instrument
Part of LIAISON
®
XS system that includes only the LIAISON
®
XS
instrument and tanks, but printer and connection cables.
Integral Reagent cartridge (made up of vials) to be inserted into the
Reagent Area.
Integral Holder Holder used for the handling of integrals outside the instrument.
Up to 16 integrals can be transported together.
Kit Set of reagents used to carry out a specific assay; it may consist
of one or more integrals, external calibrators and ancillary
reagents.
LC-le Test to verify precision of the left dispensing pipettor, carried out
by Light Check solution.
LC-ri Test to verify precision of the right dispensing pipettor, carried out
by Light Check solution.
Light Check Test tool provided as lyophilised material.
Light Check adaptor Plastic adaptor used to insert the Light Check bottles into the
Ancillary Area rack.
Liquid Waste Basin Basin used to collect spillage of contaminated liquid coming from
broken liquid waste tank.
Liquid Waste Tank Tank to collect all the liquid waste of the instrument.
Prime Start-up cycle for individual parts of instrument involved in fluidics,
carried out by using System Liquid, DI Water, Wash Buffer, Starter
Reagents and Cleaning Solution.
Rack Holder 12 positions holder used for the handling of sample and control
racks outside the instrument.
Reader Reading area in which chemical reaction and measurements
occur.
Reagent Area Integral and ancillary loading area.
4. System description
LIAISON
®
XS - Instruction for use Rev. H Page 4-9
Table 4–7: Glossary
4.2 Use of the Modules
In the following chapters, the individual modules and their use are explained.
4.2.1 Touch Screen and On Screen Keyboard
The integrated touch screen is needed to use the system. All inputs are made with a
projected capacitive (PCAP) touch compatible stylus or finger directly on the touch screen.
The usage of an external keyboard or mouse is not supported.
Touch Screen Handling
• Operate with a stylus or finger without applying excessive pressure.
• Avoid using sharp edged or hard articles.
• Keep the surface clean by executing periodic maintenance (see chapter 7.6).
RF-Tag Micro-chip present on integrals, starters and ancillaries to allow
recognition and data storage.
RLU Relative Light Unit (signal measurement unit).
Sample Area Loading area for samples.
Sample Rack 12 positions module to host sample tubes.
Samples Anything that can be introduced by operator into Sample Area
racks, including patient samples, controls and external calibrators.
Solid Waste Bin Container of the system used to host EASY Waste.
SPOLV Right arm non magnetic stainless steel probe.
Starter (reagents) Reagents dispensed during the reading to generate
chemiluminescent signal.
System The complete structure installed in the laboratory.
System Liquid Solution present in the fluidic line of the pipettor, used to wash the
pipettor probe.
Tip Single cavity plastic probe used to aspirate samples with left
pipettor arm.
Tray 96 positions modules for hosting Disposable Tips and 35 positions
modules for hosting cuvettes equipped in the Disposable Tip and
Cuvette drawer.
Vial Container for just one reagent; more vials form an integral.
Wash Buffer Solution (to be diluted 1:10 in distilled H
2
0) used to wash cuvettes.
Wash Station Washing well for right pipettor needle.
Washer Washing area in which cuvettes wash occur.
Improper use could damage the touch screen surface.
4. System description
Page 4-10 LIAISON
®
XS - Instruction for use Rev. H
Use:
• Mouse emulation:
○ Mouse pointer: Touch the screen with a finger or a stylus and the mouse pointer
will follow the moving object.
○ Single mouse click: Touch the screen once.
○ Double mouse click (double click): Touch the screen twice. Do not wait between
the first and the second touch.
• On screen keyboard (alphanumeric inputs, e.g. A - Z, 0 - 9, etc):
The LIAISON
®
XS software provides for input boxes an on screen keyboard to
enter letters or numbers. The on screen keyboard is shown automatically after
touching an input box. A smaller version is provided for numerical input.
The keyboard shows on the top left corner the current edit field content.
Figure 4–7: On screen keyboard
4.2.2 Barcode Reader
A handheld barcode reader is supplied with the system, in order to allow the user to read
bi-dimensional barcodes for control definition.
Please, refer to local representative for suitable device.
Figure 4–8: Example of Handheld barcode reader with integrated support
4. System description
LIAISON
®
XS - Instruction for use Rev. H Page 4-11
4.2.3 Disposable Tips and cuvettes
4.2.3.1 Disposable Tips
The drawer of disposable tips and cuvettes trays can be opened while the system is not
running to allow refill. When the system is running it is also possible to request the system
to suspend accessing the drawer to allow refilling.
The drawer can be filled up to two disposable tip trays with 96 disposable tips each.
The loaded disposable tip trays are recorded by the LIAISON
®
XS software
(see chapter 6.12.2). An automatic consumption meter allows the exact indication of the
disposable tips still present in the instrument.
The loading of the disposable tip trays is described in chapter 5.4.2.
Figure 4–9: Disposable Tips
Only the supplied LIAISON
®
XS handheld barcode reader may be used. The use of
unauthorized handheld barcode reader is prohibited and may cause damage to the
system.
Do not use the handheld barcode reader for purposes different from reading bi-dimensional
control definitions.
See chapter 1.6.4 for Laser Safety. Refer to handheld barcode reader user manual for
safety related instruction.
4. System description
Page 4-12 LIAISON
®
XS - Instruction for use Rev. H
4.2.3.2 Cuvettes
The drawer of disposable tips and cuvettes trays can be opened while the system is not
running to allow refill. When the system is running it is also possible to request the system
to suspend accessing the drawer to allow refilling. The cuvettes must be loaded in four trays
of 35 cuvettes each.
The loading of the cuvettes is described in chapter 5.4.1.
Figure 4–10: Cuvettes
4.2.4 Loading Bay for Sample Racks
The loading bay for sample racks allows continuous loading of the LIAISON
®
XS system
with samples. The samples in the tubes are placed in special racks and loaded in one of
the 4 lanes afterwards.
A distinct identification number must be assigned to every sample in the LIAISON
®
XS
software. This sample ID can be entered either by scanning the bar-code using the barcode
scanner located in the loading bay for sample racks or by typing it manually.
To ensure the bar-code scanner can read the bar-code label correctly, the bar-code label
must be of a good quality, thus meaning it shall match Category A or B (according to
ANSI X3.182 standard) or category 4 and 3 (according to ISO/IEC 15416 standard).
In addition, the following specifics shall be matched:
1. The module width (i.e. the width of the smallest bar or gap in the barcode) shall
be in the range 0.167 mm ≤ width ≤ 0.5 mm.
2. For Codabar and 2/5 Interleaved typologies, a minimum of 6 characters is
recommended; the bar width ratio (i.e. the comparison in bar widths between the
narrow modules and the wide modules) shall be in the range 1:2.5 ≤ ratio ≤ 1:3
(if 0.167 mm ≤ width < 0.2 mm) or in the range 1:2 ≤ ratio ≤ 1:3 (if 0.2 mm ≤ width
≤ 0.5 mm).
See Chapter 1.6.4 for Laser Safety.
4. System description
LIAISON
®
XS - Instruction for use Rev. H Page 4-13
Regarding the positioning, the barcode must be applied to the grey section in the middle of
the tube as shown in Figure 4–11.
Figure 4–11: Barcode Label
Table 4–8: Length of bar-code label
Ensure that the bar-code labels face towards the right (open side of the rack) when loading
otherwise they cannot be properly read.
In addition to the sample racks, racks with calibrators and controls may be loaded in the
loading bay for sample racks.
The loading with racks is described in Chapter 5.5.
4.2.4.1 Sample Racks
A sample rack is a holder to store patient samples (placed in sample tubes) for use on the
instrument. The sample rack (also known as “patient rack” or “rack”) is designed to hold up
to 12 sample tubes (bar-coded or non-bar-coded) and is to be inserted into the instrument
in a way such to be registered by the instrument and supports the sample tubes during
aspiration by the sample pipettor.
The Code 128 is the preferred symbology for use to ensure adequately reliable sample
traceability and recognition. Other symbologies (e.g. 2/5 Interleaved), particularly when
missing a check digit, are less reliable.
Length of tube:
Max. length of bar-code (l
bar code
)
66 mm (2.60 in.) 32 mm (1.26 in.)
75 mm (2.95 in.) 41 mm (1.61 in.)
100 mm (3.94 in.) 66 mm (2.60 in.)
Only the supplied LIAISON
®
XS approved sample racks may be used. The use of
unauthorized rack types is prohibited and may cause damage to the system.
4. System description
Page 4-14 LIAISON
®
XS - Instruction for use Rev. H
All sample racks have the same structure as pictured and described below. The positions
are numbered from 1 through up to 12 with number 1 starting farthest away from the handle.
Figure 4–12: Sample rack
Table 4–9: Sample Rack- Description
4.2.4.2 Control Racks
A control rack is a holder to store some types of control bottles and external calibrators for
use on the instrument. The control rack (also known as C rack) is designed to hold up to
8 bottles (bar-coded or non-bar-coded) and is to be inserted into the instrument in a way
such to be registered by the instrument and supports the bottles during aspiration by the
sample probes.
A set of 2 control racks is provided with each instrument.
Control racks have the structure as pictured and described below. The positions are labeled
from 1 through up to 8 with label 1 starting farthest away from the handle.
No. Description
1) Handle
2) Sample rack identification bar code label
3) Sample tube positions with position bar code label and a clamp for
correct position holding of sample tube
4) Clamp to lock the sample rack into the loading bay for sample racks
Rack ID consists of a string, the rack type, and a digit from 1 to 9. Such digit allows to
differentiate among different physical racks of the same type. The result detail contains
the Rack ID information to support the user in identifying the physical rack where the tube
is/was loaded when the aspiration took place.
Only the supplied LIAISON
®
XS control racks may be used. The use of unauthorized rack
types is prohibited and may cause damage to the system.
4. System description
LIAISON
®
XS - Instruction for use Rev. H Page 4-15
Figure 4–13: Control rack
Table 4–10: Control Racks
4.2.4.3 Rack Types, Tube Diameter and Dead Volume
There are several different types of racks (see the table below). The different types of racks
refer to the inner diameter and the total height of the sample tubes and are important for the
proper management of samples. As can be noticed, together with standard rack types,
4 typologies (Y, Z, G, O) can be directly customized by field service engineers according to
user requirements.
No. Description
1) Handle
2) Control rack identification bar-code label (%C)
3) Bottle positions with position bar-code label and position holding
4) Clamp to lock the control rack into the loading bay of the instrument
Rack
type
Internal diameter of the
sample tubes:
Total height of the
sample tubes:
Dead volume
Q6 mm ≤ 55 mm 150 µL
N7 mm ≤ 55 mm 150 µL
K8 mm ≤ 55 mm 150 µL
J 9 mm 56 mm - 65 mm 150 µL
X 10 mm 66 mm - 75 mm 150 µL
A 10 mm 86 mm - 100 mm 150 µL
I 11 mm 86 mm - 100 mm 200 µL
F 12 mm 86 mm - 100 mm 250 µL
E 13 mm 86 mm - 100 mm 300 µL
W 14 mm 86 mm - 100 mm 350 µL
B 15 mm 86 mm - 100 mm 400 µL
G Request Technical Assistance Request Technical
Assistance
Request Technical
Assistance
O Request Technical Assistance Request Technical
Assistance
Request Technical
Assistance
4. System description
Page 4-16 LIAISON
®
XS - Instruction for use Rev. H
Table 4–11: Rack types and sample tubes parameters
According to the above table, the size of the tubes that may be inserted in the sample racks
ranges from 6 through 15 mm internal diameter.
Dead Volume The dead volume is the amount of liquid left in the sample tube that cannot be pipetted by
the pipettor due to mechanical limitations and calculations. A specific dead volume level
exists for each specific tube type. When an assay is run, the user must have a minimum of
the sample amount needed to run the assay plus the dead volume amount in order to run
the assay effectively.
Example:
A user wants to run 2 tests with one sample. The sample liquid is in a sample tube with
15 mm diameter. According to the assay Instructions for use, the assay requires 20 µL per
test. The user will have to have a total of 440 µL in the tube.
Summary:
Table 4–12: Dead volume
Y Request Technical Assistance Request Technical
Assistance
Request Technical
Assistance
Z Request Technical Assistance Request Technical
Assistance
Request Technical
Assistance
C Use only for DiaSorin Italia S.p.A.
special large vials (i.e. some types of
control bottles or external
calibrators)
H
LIAISON
®
Stool extraction device
(X0034)
Dedicated Adaptor
needed (PN: A0214)
300 µL
L Used only for DiaSorin Italia S.p.A.
glass vials (i.e. some types of control
bottles or external calibrators)
55 ±0.5 mm
M Calprotectin extraction device
(X0043)
P Used only for pediatric tubes
Rack
type
Internal diameter of the
sample tubes:
Total height of the
sample tubes:
Dead volume
Tubes with 15 mm diameter: 400 µL (dead volume)
2 tests with 20 µL: 40 µL (usable sample volume)
Total volume needed: 440 µL
In the case of plasma gel separator containers, the amount of sample should be at least
500 µL plus the volume required to run the test.
4. System description
LIAISON
®
XS - Instruction for use Rev. H Page 4-17
4.2.5 Loading Bay for Reagents (Integrals and Ancillary Reagents)
Figure 4–14: Front view of the loading bay for reagents
Table 4–13: Loading Bay for Reagents
The loading bay for reagents allows a continuous loading of the LIAISON
®
XS system with
reagents in the form of integrals or ancillary reagents.
Integrals:
• Up to 10 integrals can be used at the same time.
• Integrals can be loaded directly into one of the 10 lanes according to the
specifications of the LIAISON
®
XS.
• For the front position of the integral, a stirrer drive is provided. With the stirrer drive,
magnetic particles can be evenly distributed in the reagent.
Ancillary reagents:
• Up to 4 ancillary reagents or reagents can be used at the same time.
• Ancillary reagents must be placed in an ancillary rack with adapters before usage.
Then, the ancillary rack can be loaded in the special lane (on the very left)
according to the specifications of the LIAISON
®
XS software.
Insufficient or Missing Patient Sample Liquid
Insufficient or missing patient sample liquid might create erroneous sample aspirations.
Therefore, a warning message will be given together with an audible signal. The test must
be repeated after a sufficient level of sample has been inserted.
1) Lane for ancillary reagents and additional reagents
2) 10 lanes for integrals
3) Flap
4. System description
Page 4-18 LIAISON
®
XS - Instruction for use Rev. H
Figure 4–15: Ancillary rack
The information included in the integral or ancillary reagent (RFID label) is read and used
in the LIAISON
®
XS software.
The loading bay for reagents is cooled during the complete operation (incl. stand-by mode).
The liquid inside the integrals and ancillary reagents are cooled to 13 °C ±2 °C.
Before using integrals or ancillary reagents, read the IFU (instructions for use) provided in
the reagent package (storage, preparation)!
Observe instructions for a correct re-suspension of magnetic particles.
Always use an ancillary rack in combination with the system it has been provided with.
To avoid temperature errors of the reagent loading bay, the flaps should be opened only
briefly for loading and unloading. The system will beep to remind to close it.
4. System description
LIAISON
®
XS - Instruction for use Rev. H Page 4-19
4.2.5.1 External Reagents
DiaSorin external reagents are delivered in vials separated from the integral, for example
lyophilized kit reagents, or Light Check for troubleshooting.
These vials are of appropriate dimensions made to fit dedicated adaptors for the ancillary
rack. This is the only rack type to be used for these vials.
External kit reagents, that shall be used as part of a test routine, are provided mounted on
a specific non removable adaptor. Reagents like Light Check, that are not to be used as
part of a regular test routine, are to be inserted into adaptors provided with the instrument
or are to be inserted into a suitable sample rack.
The information included in the reagent (RFID label) is read from the system and used in
the LIAISON
®
XS software.
4.2.6 Integrated re-suspension tool
The integrated resuspension tool is a solid state magnetic device which aids in the dispersal
of microparticles prior to placement of a LIAISON
®
XS reagent integral on the
LIAISON
®
XS system.
For a LIAISON
®
XS reagent integral to perform as intended, the microparticles must be
completely and homogeneously re-suspended. The integrated tool is designed to assist in
the preparation of the reagent integral by magnetically drawing the paramagnetic
microparticles away from the bottom of the reagent integral microparticle vial.
With subsequent agitation of the vial automatically performed by the instrument over a
15 minutes time span, the operator is ensured of a properly prepared reagent integral.
4.2.6.1 Use of the integrated re-suspension tool
1. Slide the reagent integral into the slot until it is fully engaged;
2. Allow the reagent integral to remain in the tool for at least 30 seconds;
3. Remove the integral and inspect for the presence of particles at the bottom of the
vial: if microparticles are still present at the bottom, repeat procedure as many
times as needed to have a complete removal;
4. After a complete removal of particles from the bottom of the vial has been
achieved, insert the integral in an available slot in the reagent area and let it
agitate for 15 minutes before starting a run.
4.2.7 Area for Starter Reagents
The area for starter reagents contains the two starter reagents (LIAISON
®
EASY Starter
Kit: Starter 1 and Starter 2). The two starter reagent bottles are provided with removable
screw caps that have to be removed to allow the insertion of the dedicated tubing.
Correct emplacement is ensured by a clamp holding on a reset on the bottle neck. A RFID
in the back of the bottle identifies starter reagents and tracks consumption. Since the starter
reagents are light sensitive, the flap of the area must always be closed.
To prevent confusion, the information included in the starter reagent (RFID label) is read
from the system and used in the LIAISON
®
XS software.
Please read the instructions for use (IFU) concerning the starter reagents
(LIAISON
®
EASY Starter Kit).
4. System description
Page 4-20 LIAISON
®
XS - Instruction for use Rev. H
4.2.8 EASY Waste
A special box for solid waste is used in the Solid Waste Bin.
Refer to chapter 5.4.7 for assembling and use.
4.2.9 Liquid Tank
4.2.9.1 System liquid tank
If the level in the system liquid tank falls below a certain mark, the LIAISON
®
XS software
indicates to refill the tank soon.
Ongoing tests are still completed. New tests can only start if the contents of the tank are
above the switch level.
4.2.9.2 Wash buffer tank
If the level in the wash buffer tank falls below a certain mark, the LIAISON
®
XS software
indicates to refill the tank soon.
Ongoing tests are still completed. New tests can only start if the contents of the tank are
above the switch level.
4.2.9.3 Cleaning solution tank
The system supports a cleaning procedure with a suitable cleaning solution tank.
See chapter 7.
4.2.9.4 DI Water tank
The system supports a cleaning procedure where also DI Water is used, for rinsing
purposes. The Cleaning tank shall be used for the maintenance steps where the use of DI
Water is required; as alternative, a dedicated DI Water tank can be ordered and used for
such steps.
4.2.10 Inside the instrument
4.2.10.1 Incubator
Up to 57 cuvettes are placed in the incubator. The cuvettes are loaded and unloaded from
above by a gripper. There are two loading positions: one for the outer ring with 32 positions
and one for the inner ring with 25 positions. The two rings are separated by a wall to avoid
contamination between rings.
Always keep the starter reagent area closed to avoid light.
4. System description
LIAISON
®
XS - Instruction for use Rev. H Page 4-21
4.2.10.2 Pipettors
The LIAISON
®
XS system is provided with two independent pipettors to distribute samples
and reagents throughout the testing processes. The two pipettors can aspirate variable
liquid volumes of samples or reagents and dispense them into the cuvettes in the incubator.
Left Pipettor for samples
The left pipettor working with disposable tips aspirates liquid from a specified sample,
control or external calibrator and dispenses it into a cuvette. The LIAISON
®
XS software
associates the dispensed sample and the test to be processed to the cuvette.
Additionally, the sample pipettor allows the transfer of liquid from one cuvette to another in
order to perform sample pre-dilutions.The use of disposable tips prevents cross-
contamination between samples, controls or external calibrators.
This pipettor, located on the left side of the system, can only reach the loading bay for
samples during a test routine.
Right Pipettor, for reagents
A stainless steel probe pipettor aspirates liquid from one or more reagent vials (integral or
ancillary reagent) and dispenses it into a cuvette.
The inside and outside of the steel probe is cleaned in the wash station after the process
step, in such a way as to prevent cross-contamination between different reagents.
Checks
To ensure the correct aspiration of liquid, both pipettors are provided with a liquid level
detection system and volume aspiration and dispensing monitoring. The combination of the
two allows for the aspiration of liquid(s) from the appropriate position and for the control of
the accuracy of the dispensation. Additionally, the left pipettor can detect whether there are
clots in a sample.
4.2.10.3 Reader
The dispensing of the two starter reagents and the chemiluminescence measurement are
carried out in the reader, equipped with a high sensitivity photomultiplier. The reader is
sealed from all outside light influences. The two independently controlled injection pumps
for injection of the starter reagents are placed outside the reader: each of them operates
with a constant volume of 200 µL to inject starter reagents into the cuvette. One injection of
each of the two starter reagents (starter 1 and starter 2) is needed in order to develop the
chemiluminescent reaction.
The geometrical arrangement of the injectors in the Reader ensures that the injection of
starter 1 is directed against the wall of the cuvette. Starter 2 is injected straight into the
cuvette. This ensures optimum re-suspension of the magnetic particles. After each
individual measurement and before cuvette disposing, the reaction solution is drawn from
the cuvette by an aspiration needle. Once completed this operation, the cuvette is then
disposed off into the waste box.
4.2.11 Holders
4.2.11.1 Rack Holder
A dedicated holder is available for handling of sample and control racks outside the
instrument. Up to 12 racks can be transported at the same time using this holder.
4. System description
Page 4-22 LIAISON
®
XS - Instruction for use Rev. H
4.2.11.2 Integral Holder
A dedicated holder is available for handling of reagent kits outside the instrument. Up to
16 kits can be transported at the same time using this holder; dedicated positions are
available to host kits composed by 2 integrals.
4.2.12 Status Light
In the front of the LIAISON
®
XS system is a status light that informs about the conditions
of the instrument:
Figure 4–16: Status light
Color
Light
Status Description
Off Off • No Power
• Not Initialized
• Initializing
Blue Slow flashing • Resume
• Running
• Maintenance
Blue Steady • Standby
• Ready
Yellow Fast flashing • Halted
4. System description
LIAISON
®
XS - Instruction for use Rev. H Page 4-23
Table 4–14: Status Light
4.2.13 Printer
An USB printer can be connected to the instrument by authorized DiaSorin Italia S.p.A.
service personnel. Both local and network printers are supported; the printer connected to
the instrument shall be set as “default printer”.
Yellow Slow flashing If a beep of the following type is triggered and the status is
not “halted”, then the status light change as described until
the user mutes the beep or the auto mute is triggered.
• System error
• Info
Color
Light
Status Description
4. System description
Page 4-24 LIAISON
®
XS - Instruction for use Rev. H
5. Use of the System
LIAISON
®
XS - Instruction for use Rev. H Page 5-1
5 Use of the System
In this chapter, the processing of a test from switching on the system to switching off the
system for an user is described in regards to starting a worklist.
All functions of the LIAISON
®
XS software are described in Chapter 6.
5.1 Safety and Hints
5.2 Typographical Conventions
Software
Figure 5–1: Screen
Conditioning time
The system requires 1 hour for temperature conditioning of the incubator and the reagent
loading bay from an off system startup.
See chapter 1.6 for all safety hazards.
5. Use of the System
Page 5-2 LIAISON
®
XS - Instruction for use Rev. H
Table 5–1: Software
1
Main categories
Tap on the respective tab to change the main category.
Example: Tap on the System main category tab.
2
Sub categories:
Tap on the respective tab to show details of the sub category in the
sub category display.
Example: Tap on the Settings sub category tab.
3
Display:
Shows all details of the selected sub category.
Example: The system shows all functions on the Settings sub
category display.
4
Left Header:
Shows information about the system and contains the Stop, Start and
Help buttons.
Example: The system status is shown on the Left Header.
5
Tabs:
Subdivides a sub category into different areas.
Example: Tap on the Language tab.
6
Buttons:
Tap on the respective button to start a special function.
Example: Tap on the Default button.
7
Selection boxes:
Tap on the arrow and select one of the shown entries.
Example: Select the Random Access entry of the Mode selection box.
8
Checkboxes:
Tap on the square or circle box to activate a function or option.
A checkmark in a square box of a checkbox shows an activated
function/option.
A point in a radio button shows an activated function/option.
These types of radio buttons are organized in groups. Only one radio
button for each group can be activated.
Example: Activate the Auto log-off checkbox.
9
Input boxes:
Use the on screen keyboard to write into an input box. If the field has
an highlighted background, it contains a wrong value (e.g. it can be a
mandatory field). See also section Tooltips below.
Example: Enter the new value in the Minutes box.
10
Tooltips:
Tooltips are used to inform the user about wrong values in input
boxes. After entering the correct value, the tooltips disappear.
-
Groups:
Combines functions to groups.
Example: All temperatures are shown in the Temperatures group in
Summary sub-toggle.
5. Use of the System
LIAISON
®
XS - Instruction for use Rev. H Page 5-3
Miscellaneous
Table 5–2: Miscellaneous
Daily activities plan
Table 5–3: Daily activities
Status light Describes signal lamp of the instrument.
SW LEDs Describe the availability of resources (sample racks, integral and
ancillary reagents) on the GUI
Keys Describes special keys of the on screen keyboard.
Example: Press on the Enter key to confirm the entry.
Drives, folders,
and files
Describes special drives (hard disks, USB sticks) of the computer or
special folders and files on the computer.
Example: Choose D:\LiaisonXS\Share as backup path.
Prescribed
parameters
Describes special parameters or values to enter into an input box.
Example: Enter 10 into the shown input box.
Start-up • Switch-on (only if off)
• Log-on
• Respect the conditioning time
chapter 5.3
Check • Check cuvettes, disposable tips, starter
reagents and liquid Tanks
chapter 5.4
Load Integrals and
Ancillary reagents
• Load integrals
• Load ancillary reagents
chapter 5.6
Load Controls and
Calibrators
• Load controls
• Load calibrators
chapter 5.5
chapter 5.6
Calibrate integrals • Calibrate integrals
• Run controls to validate calibrations
chapter 5.6
chapter 5.5
Load Samples and
Assign Assays
• Load patient samples
• Assign assays to the patient samples
chapter 5.5
Start Worklist • Check the upfront estimation
• Start the run
chapter 5.7
Results • Check results chapter 5.8
Errors and Events • Check errors and events chapter 5.8.5
Unloading • Unload unused sample racks
• Unload unused integrals
• Unload unused ancillary reagents
chapter 5.10
Shut Down/End of
Day Maintenance
• Ensure to have the System Liquid on board and
above the availability threshold
• Ensure to solid and liquid waste on board and
below the availability threshold
• If planned for today, perform periodical
maintenance
chapter 5.11
and 6.11
5. Use of the System
Page 5-4 LIAISON
®
XS - Instruction for use Rev. H
5.3 Start up
Procedure Switch on and log-on:
1. Ensure that the cover and the flaps are closed.
2. Ensure that the analyzer main switch is on the “ON” position:
Figure 5–2: Main switch, ON position
5. Use of the System
LIAISON
®
XS - Instruction for use Rev. H Page 5-5
3. Check the soft power button and press it when the light stops blinking:
Figure 5–3: Soft power button
The system starts the operating system and the LIAISON
®
XS software on the integrated
Panel-PC.
4. After system start, the LIAISON
®
XS software shows the Startup display:
Figure 5–4: Startup display
5. Use of the System
Page 5-6 LIAISON
®
XS - Instruction for use Rev. H
Table 5–4: Functions available on Startup display
5. Tap on the LIAISON
®
XS button.
The LIAISON
®
XS software shows the Login display
Figure 5–5: Login
6. Enter the user name into the Username box.
The user name is not case sensitive.
7. Enter the appropriate password into the Password box.
The password is case sensitive.
8. Tap on the Login button.
9. From the STOP menu, initialize the system.
The LIAISON
®
XS software initializes the instrument and shows the Loading
Samples display.
Function Description
Shutdown Shut the PC system software and switch off the computer.
Virus Scan Starts the virus scan software. In case a virus is reported, please
contact local support.
QC Start the long term quality control (QC) application.
Monitor Start the procedure to calibrate the touch screen.
Liaison XS
Start the LIAISON
®
XS software.
There are several security levels of user access rights on the LIAISON
®
XS system.
Some system functions are only available for users with an appropriate access level
(e.g. changing system options, or setting user accounts).
The system spontaneously performs an automated back-up of temporary files upon
starting the LIAISON
®
XS software. This action will improve the Panel-PC performance.
5. Use of the System
LIAISON
®
XS - Instruction for use Rev. H Page 5-7
Conditioning time:
10. Wait for 1 hour. The system requires 1 hour for temperature conditioning of the
incubator and the reagent loading bay from an off system startup.
5.4 Check Cuvettes, Disposable Tips, Starter Reagents
and Liquid Tanks
At the beginning of each run, the filling level of the liquid tanks and the starter reagents must
be checked, as well as sufficient cuvettes and disposable tips available in the instrument.
Procedure 1. Tap on the Status main category tab.
2. Tap on the Summary sub category tab.
Figure 5–6: Summary
System Liquid
Wash buffer
Available Depleted Absent
> 1 l ≤ 1l
Note: if the “Autoresume” option is enabled (see chapter 6.9.5), ensure that the System
Liquid tank is connected and above the availability threshold to successfully prime it.
Note: System Liquid is also used for periodical SPOLV rinsing in Standby or Ready status.
Available Depleted Not Primed Absent
> 1 l ≤ 1l
Note: if the “Autoresume” option is enabled (see chapter 6.9.5), ensure that the Wash
Buffer tank is loaded and above the availability threshold to successfully prime it.
5. Use of the System
Page 5-8 LIAISON
®
XS - Instruction for use Rev. H
Liquid waste
Starter reagents
Cuvettes
Tips
Solid waste
Consumable
group
3. Check the number of cuvettes. If low, refill them (see chapter 5.4.1).
4. Check the number of disposable tips. If low refill them (see chapter 5.4.2).
Available Full Absent
< 7 l ≥ 7l
Available Depleted
Not primed/
Expired
Absent Error
> 4 shots ≤ 4shots
Note: Starters can be reported as depleted even in case they have more than 4 shots left
if the system hasn’t sufficient shots to prime them.
If the “Autoresume” option is enabled (see chapter 6.9.5), ensure that the Starter bottles
are loaded and above the availability threshold to successfully prime them.
Available Depleted Absent (drawer pulled out)
> 2 ≤ 2
Note: Cuvettes threshold is referred to the number of cuvettes in trays.
If the “Autoresume” option is enabled (see chapter 6.9.5), ensure that at least 2 cuvettes
are available in the plastics drawer to successfully prime Wash Buffer and Starters.
Available Full Absent (drawer pulled out)
> 0 0
Available Full Absent
< 178 ≥ 178
See chapter 1.6.6 for Biological Safety.
5. Use of the System
LIAISON
®
XS - Instruction for use Rev. H Page 5-9
Starter
reagents
group
5. Check the levels of the both starter reagent bottles. If low, load the new bottles
(see chapter 5.4.3).
The remaining injection counters of all loaded starter reagents are shown.
The counter decreases after every injection.
System Fluids
group
6. Check the level of Wash Buffer. If low, prepare a new wash buffer
(see chapter 5.4.5) according to the Instruction for Use.
7. Check the level of System Liquid. If low, prepare a new system liquid
(see chapter 5.4.4) according to the Instruction for Use.
Temperatures 8. Check the temperatures.
Table 5–5: Temperatures
Waste group 9. Check the capacity of the liquid waste tank. If full or nearly full, empty and follow
the instructions of chapter 5.4.6.
10. Check the level of the EASY Waste Box. If full or nearly full, close it with its own
cap, dispose of it and load a new one into the solid waste bin (see chapter 5.4.7).
After that, tap on the Reset button .
5.4.1 Refill Cuvettes
Module Temperatures Min. Temperatures Max.
Reaction 35.0 °C 37.0 °C
Reagents 11.0 °C 15.0 °C
Injection 1 33.0 °C 37.0 °C
Injection 2 33.0 °C 37.0 °C
Before starting the handling procedure, consult Instruction for Use (IFU) for Cuvettes.
Always keep user box in an upright position, as indicated in the label (Figure 5-5 (a)
Ref 1).
Always keep the cuvette tray(s) in an upright position.
5. Use of the System
Page 5-10 LIAISON
®
XS - Instruction for use Rev. H
1. Tap on the Status main category tab and check the Cuvettes in the Plastics
group.
Figure 5–7: Cuvettes status
2. Check that it is possible to open the plastics drawer from the Status - Plastics
page: the drawer can be immediately opened in case the page reports that this is
possible. In case the system has programmed any access to the drawer, it is
possible to request the system to suspend the access to the drawer to load tips
and cuvettes. For the procedure, see chapter 6.
3. Open the drawer of the Cuvettes and Disposable Tips.
4. If present remove the empty cuvettes tray(s).
5. Hold the user box in upright position and open the box lid by cutting the label
along the line (Figure 5-5 (a) Ref 2).
6. Unpack the inner plastic bag and remove the cuvettes on tray(s), keeping it/them
by the apposite handle. If the user box is not empty wrap again the plastic bag
on the remaining cuvettes on tray(s) and close the box lid (Figure 5-5 (b)).
5. Use of the System
LIAISON
®
XS - Instruction for use Rev. H Page 5-11
7. Keeping the tray by the handle,slide it in the drawer following the visual help
(laser marking profile) until both front pins are correctly engaged into the proper
holes. Push down the button located on the top of the tray handle until it locks
into place (Figure 5-6).
Figure 5–8: Open and close the user box, unpack and wrap the plastic bag
5. Use of the System
Page 5-12 LIAISON
®
XS - Instruction for use Rev. H
Figure 5–9: Slide, engage and push down the cuvette tray
Make sure that no cuvettes protrude upwards. Otherwise the drawer cannot be closed.
5. Use of the System
LIAISON
®
XS - Instruction for use Rev. H Page 5-13
Figure 5–10: Cuvette stands out, drawer blocks
8. In Status - Plastics page, use the button “Fill Tray”/“Fill Trays” to assign the
loaded cuvette tray(s) (see chapter 6.12.2).
9. Close the drawer.
10. Tap on the Status main category tab and check the Cuvettes number in the
Plastics again.
5.4.2 Refill Disposable Tips
Cuvettes are for single use only.
Before starting the handling procedure, consult Instruction for Use (IFU) for
Disposable Tips.
Always keep user box in an upright position.
Always keep the tip tray(s) in an upright position.
5. Use of the System
Page 5-14 LIAISON
®
XS - Instruction for use Rev. H
Procedure
1. Tap on the Status main category tab and check the Disposable
Tips in the
Consumables.
Figure 5–11: Status Disposable Tips
2. Check that it is possible to open the plastics drawer from the Status - Plastics
page: the drawer can be immediately opened in case the page reports that this is
possible. In case the system has programmed any access to the drawer, it is
possible to request the system to suspend the access to the drawer to load tips
and cuvettes. For the procedure, see chapter 6.
3. Open the drawer of the Cuvettes and Disposable Tips.
4. If present, remove the empty tip plate(s).
5. Take a disposable tip tray from the packaging.
5. Use of the System
LIAISON
®
XS - Instruction for use Rev. H Page 5-15
Figure 5–12: Packaging of the Disposable Tips holder
5. Use of the System
Page 5-16 LIAISON
®
XS - Instruction for use Rev. H
6. Open one side of the folding sleeve by pulling up one of the available flaps
(as indicated by the arrow symbols, Figure 5-10).
Figure 5–13: Folding sleeve opening
5. Use of the System
LIAISON
®
XS - Instruction for use Rev. H Page 5-17
7. Insert the holder in the drawer until it is engaged (Figure 5-11). Push down the
holder until it locks into place (Figure 5-12).
Figure 5–14: Insert the Disposable Tips plate
5. Use of the System
Page 5-18 LIAISON
®
XS - Instruction for use Rev. H
Figure 5–15: Push down the Disposable Tips plate
8. In Status - Plastics page, use the button “Fill Plate”/“Fill Plates” to assign the
loaded tip plate(s) (see chapter 6.12.2).
9. Close the drawer.
10. Tap on the Status main category tab and check the Tips number in the Plastics
again.
5.4.3 Load and Unload the Starter
All disposable tips are for single use only.
The starter reagents also include 4 % sodium hydroxide and a 0.12 % peroxide solution.
If splashes of the NaOH solution or the alkaline peroxide solution get into eye or in contact
with skin, immediate and thorough washing with water or a suitable buffer solution is
recommended. If necessary, a physician should be consulted. See also product related
material safety data sheet.
Starter pooling is prohibited!
Refer to the safety notes (see chapter 1.6).
5. Use of the System
LIAISON
®
XS - Instruction for use Rev. H Page 5-19
The LIAISON
®
EASY Starter Kit should be kept away from direct sunlight.
Please comply with the storage and shelf life information for the starter reagents
(LIAISON
®
EASY Starter Kit).
1. Tap on the Status main category tab in the Summary tab and check both
starters. If one of the starter is “Depleted”, then unload the respective starter
bottle.
2. Ensure that the instrument is not in “running” or “maintenance” status before
unload/load the Starter bottles.
Figure 5–16: Status Starters
5. Use of the System
Page 5-20 LIAISON
®
XS - Instruction for use Rev. H
Unload
Procedure
1. Open the flap for starter reagents.
2. Remove the empty starter reagent bottle by lifting it on the tab.
Figure 5–17: Remove starter reagent bottle
5. Use of the System
LIAISON
®
XS - Instruction for use Rev. H Page 5-21
3. Remove the cap of the empty starter reagent bottle by pressing the brackets.
Figure 5–18: Press the brackets
5. Use of the System
Page 5-22 LIAISON
®
XS - Instruction for use Rev. H
Load
Procedure
1. Remove the locking cap of the new starter reagent bottle.
2. Place the LIAISON
®
XS system cap onto the new starter reagent bottle by
pressing the brackets.
Figure 5–19: Place the cap by pressing the brackets
It is essential to ensure correct connection to Starter 1 and Starter 2.
5. Use of the System
LIAISON
®
XS - Instruction for use Rev. H Page 5-23
3. Insert the new starter reagent bottle into the LIAISON
®
XS system by holding it
on the tab.
Figure 5–20: Holding it on the tab
4. Close the flap for starter reagents.
In case lot numbers change, after the starters have been primed it is necessary to
recalibrate all integrals. The system will disable all valid calibrations.
5. Use of the System
Page 5-24 LIAISON
®
XS - Instruction for use Rev. H
5.4.4 Load and Unload the System Liquid Tank
1. Tap on the Status main category tab and check System Fluids.
2. Ensure that the instrument is not in “running” or “maintenance” status before
disconnecting the System Liquid tank.
Figure 5–21: Status System Fluids - System Liquid
Preparation Before the system liquid preparation, the System Liquid tank must be horizontal, as it is
on-board the instrument, so that the filling line can be used. The lower edge of the filling
line at the opposite side of the tank handle marks the 5 liter level.
Figure 5–22: System liquid tank - 5 liter filling line, lower edge marked in red
5. Use of the System
LIAISON
®
XS - Instruction for use Rev. H Page 5-25
Figure 5–23: Preparation of System Liquid - correct placement of the System liquid tank
For the preparation of the system liquid solution, refer to the instructions for use of the
LIAISON
®
EASY System Liquid.
Before the system liquid is handled or loaded into the LIAISON
®
XS system, the package
information is to be read thoroughly and followed by the user. Use the notches available
on the tank as an aid during the preparation of the system liquid solution.
The System Liquid tank must fulfill the requested ambient operating conditions during
installation and should never be used after defined expiration date for onboard stability.
Incorrect mixed or used solutions in the System Liquid tank
Use of incorrect solutions leads to faulty results and damage to the instrument.
If solutions have been misused, clean the System Liquid tank according to chapter 7.5
before preparing the new system liquid solution. After loading it into the instrument, the
system liquid shall be primed before starting any activities.
For the preparation, the System Liquid tank must be horizontal.
5. Use of the System
Page 5-26 LIAISON
®
XS - Instruction for use Rev. H
Unload
Procedure
1. Open the bulk fluid door.
2. Remove the lower tank by lifting it at the handle.
Figure 5–24: Remove the System Liquid tank.
The back-illumination of the tank turns off automatically if the tank is not connected to the
instrument.
Figure 5–25: Remove tank cap
For the preparation of the system liquid solution, the cap of the tank shall be removed.
5. Use of the System
LIAISON
®
XS - Instruction for use Rev. H Page 5-27
Load
Procedure
1. Ensure that the cap of the tank is closed.
2. Load the tank on the lower position of the bulk fluid area.
3. Close the bulk fluid door.
4. The System liquid will be displayed as “Not Primed”. Before starting any
activities, it shall be primed.
5.4.5 Load and Unload the Wash Buffer Tank
1. Tap on the Status main category tab and check System Fluids.
2. Ensure that the instrument is not in “running” or “maintenance” status before
disconnecting the wash buffer tank.
Figure 5–26: Status System Fluids - Wash Buffer
If the tank is loaded correctly, the back-illumination will turn on again.
5. Use of the System
Page 5-28 LIAISON
®
XS - Instruction for use Rev. H
Preparation 1. Before the wash buffer preparation, the Wash Buffer tank must be horizontal, as
it is on-board the instrument, so that the filling line can be used. The lower edge
of the filling line at the opposite side of the tank handle marks the 2.7 liter level.
Figure 5–27: Wash buffer tank - 2.7 liter filling mark, lower edge marked in red
Figure 5–28: Preparation of Wash buffer - correct placement of the Wash Buffer tank
For the preparation of the wash buffer solution, refer to the instructions for use of the
LIAISON
®
EASY Wash Buffer.
Before the wash buffer is handled or loaded into the LIAISON
®
XS system, the package
information is to be read thoroughly and followed by the user. Use the notches available
on the tank as an aid during the preparation of the wash solution.
5. Use of the System
LIAISON
®
XS - Instruction for use Rev. H Page 5-29
Unload
Procedure
1. Open the bulk fluid door.
2. Remove the upper tank by lifting it at the handle.
The back-illumination of the tank turns off automatically if the tank is not connected to the
instrument.
The wash buffer tank must fulfill the requested ambient operating conditions during
installation and should never be used after defined expiration date for onboard stability.
Freshly prepared or non-degassed wash buffer should not be used in the LIAISON
®
XS
system.
For the preparation, the Wash Buffer tank must be horizontal.
The Wash Buffer tank should be kept away from direct sunlight.
Incorrect mixed or used solutions in the Wash Buffer tank
Use of incorrect solutions leads to faulty results and damage to the instrument.
If solutions have been misused, clean the Wash Buffer tank according to chapter 7.5
before preparing the new wash buffer solution. After loading it into the instrument, the
wash buffer shall be primed before starting any activities.
5. Use of the System
Page 5-30 LIAISON
®
XS - Instruction for use Rev. H
Figure 5–29: Remove tank cap
Load
Procedure
1. Ensure that the cap of the tank is closed.
2. Load the tank on the upper position of the bulk fluid area.
3. Close the bulk fluid door.
4. The Wash Buffer will be displayed as “Not Primed”. Before starting any activities,
it shall be primed.
5.4.6 Connecting and separating the Liquid Waste
1. Tap on the Status main category tab and check the Liquid Waste.
For the preparation of the wash buffer solution, the cap of the tank shall be removed.
If the tank is loaded correctly, the back-illumination will turn on again.
See chapter 1.6.6 for Biological Safety.
5. Use of the System
LIAISON
®
XS - Instruction for use Rev. H Page 5-31
2. Ensure that the instrument is not in “running” or “maintenance” status before
unload/load the waste tank.
Figure 5–30: Status Waste - Liquid Waste
Description The joint connector is used to manage the insertion/ removal of both the tubing and the
connector for the waste sensor as a single task. A membrane element avoids splashing of
liquid when the liquid connector is removed.
Table 5–6: Liquid waste tank with sensor/ liquid joint connector
Item Description
1) Sensor connector
2) Liquid tubing connector
3) Plastic joint
4) Membrane
5) Rubber strip
6) Cap
7) Sensor cable
5. Use of the System
Page 5-32 LIAISON
®
XS - Instruction for use Rev. H
Figure 5–31: Liquid waste tank with sensor/ liquid joint connector
5. Use of the System
LIAISON
®
XS - Instruction for use Rev. H Page 5-33
During the unload phase, the removal of the connector from the waste sensor also implies
a removal of the liquid tubing from the dedicated membrane; the system is designed as the
connector is completely unplugged before the liquid tubing is pulled completely out of the
membrane.
Figure 5–32: When unplugging the connector, the tubing is also pulled out of the
membrane
5. Use of the System
Page 5-34 LIAISON
®
XS - Instruction for use Rev. H
During the load phase the insertion of the liquid tubing into the membrane also implies the
connection of the sensor; the tubing is pushed into the membrane before the connector is
completely plugged (i.e. an audible click is heard when connection is performed).
Figure 5–33: When pushing the tubing into the membrane, the connector is also plugged
into the sensor
5. Use of the System
LIAISON
®
XS - Instruction for use Rev. H Page 5-35
Unload
procedure
1. Unplug the sensor connector (1). Due to the presence of the plastic joint (3),
the liquid tubing connector (2) will be also removed from the membrane (4).
Insert the sensor connector together with the liquid tubing connector inside the
dedicated plastic housing (8) of the Liquid Waste Basin (9) (see figure 5–34).
Figure 5–34: Liquid Waste Basin
2. Before moving the tank from the Liquid Waste Basin of the instrument, close the
sensor connector with its black cap and turn the rubber strip (5) to cover the
membrane (4) by using the available cap (6).
Figure 5–35: Rotation of the rubber strip and closure of the membrane with the cap
5. Use of the System
Page 5-36 LIAISON
®
XS - Instruction for use Rev. H
3. Once the available waste disposal area is reached in the laboratory, empty the
liquid waste tank and preferably add 200 mL of commercial hypochlorite or
bleach.
Load
Procedure
1. Insert the Liquid Waste Tank into the Liquid Waste Basin (see Figure 5–34).
2. Remove the cap (6) from the membrane (4) by turning the rubber strip (5) and
the black cap from the sensor connector. Caps shall be removed only just before
plugging the sensor connector and the liquid tubing.
Figure 5–36: Rotation of the rubber strip and opening of the membrane
In order to prevent splashes of liquid waste from the tank, always close the sensor
connector and the membrane with their own caps before handling the tank.
During the liquid waste disposal, do not remove the caps from the sensor connector and
from the membrane.
5. Use of the System
LIAISON
®
XS - Instruction for use Rev. H Page 5-37
3. Ensure that the sensor cable is oriented to the front. Also ensure that the male &
female grooves are aligned.
Figure 5–37: Sensor connector alignment
4. Push the liquid tubing connector (2) into the membrane (4). Due to the presence
of the plastic joint (3), the insertion of the liquid tubing connector (2) into the
membrane (4) also implies the insertion of the connector into the waste
sensor (1). An audible click is heard when the sensor connection is completed.
Figure 5–38: Insertion of sensor and liquid tubing connectors
5. Use of the System
Page 5-38 LIAISON
®
XS - Instruction for use Rev. H
5. Check the Summary of the Status menu. The LIAISON
®
XS SW must show the
symbol for an empty tank correctly connected.
Figure 5–39: Liquid Waste
5.4.7 Load and Unload the LIAISON
®
EASY Waste
1. Tap on the Status main category tab and check the Solid Waste.
2. Ensure that the instrument is not in “running” or “maintenance” status before
unload/load the solid waste.
Figure 5–40: Solid Waste
Other symbols may indicate bad/ wrong connection status, therefore leading to
malfunctions with consequent risk of spillage of waste liquid.
See chapter 1.6.6 for Biological Safety.
The LIAISON
®
XS system does not monitor the presence of the LIAISON
®
EASY Waste,
therefore the user shall ensure that it is loaded before starting a run.
Do not pre-assemble the Easy waste container.
5. Use of the System
LIAISON
®
XS - Instruction for use Rev. H Page 5-39
LIAISON
®
EASY Waste
Assembling
Instruction
1. Start with the cardboard having the absorbent cloth and with the assembling
instruction on the side down.
2. To ensure an easier assembling, fold all the marked crease.
3. Following the marked crease, fold upwards the two side flaps and fold internally
the two extremities close to the absorbent cloth; pull upward the side over the
absorbent cloth (see Figure 5–41 step A1).
Figure 5–41: LIAISON
®
EASY Waste assembling instruction step A1
4. Remove the two double-sided adhesive tapes from the cardboard raised in
step A1 of the figure 5–41 and glue the two creases folding them on the two side
flaps (see Figure 5–42 step A2). Press the two side flaps in order to ensure the
complete gluing of the adhesive tapes.
Figure 5–42: LIAISON
®
EASY Waste assembling instruction step A2
5. Use of the System
Page 5-40 LIAISON
®
XS - Instruction for use Rev. H
5. Turn the cardboard in front of the side already folded; following the marked
crease, fold upwards the two side flaps, fold internally the two extremities and
remove the two double-sided adhesive tapes; pull upward the side having the
eyelet and glue the two creases folding them on it (see Figure 5–43 step A3).
Press the two side flaps in order to ensure the complete gluing of the adhesive
tapes.
Figure 5–43: LIAISON
®
EASY Waste assembling instruction step A3
6. Place the assembled cardboard on a cleaned surface and take the other
cardboard provided with the EASY waste (cap).
7. Following the marked crease, fold upwards the two side flaps and fold internally
the two extremities; fold the flap against the two extremities and fold it again
down in order to insert it the corresponding holes (see Figure 5–44 step B1).
Figure 5–44: LIAISON
®
EASY Waste assembling instruction step B1
5. Use of the System
LIAISON
®
XS - Instruction for use Rev. H Page 5-41
8. When the EASY Waste in the instrument is full, before dispose it in the biological
waste, insert the un-folded portion of the cap in the dedicated portion of the box
(see Figure 5–45 step C1).
Figure 5–45: LIAISON
®
EASY Waste assembling instruction step C1
9. Insert the eyelet of the Easy Waste box in the hole of the EASY Waste cap
(see Figure 5–46 step C2).
Figure 5–46: LIAISON
®
EASY Waste assembling instruction step C2
5. Use of the System
Page 5-42 LIAISON
®
XS - Instruction for use Rev. H
Figure 5–47: LIAISON
®
EASY Waste instruction
Figure 5–48: assembled LIAISON
®
EASY Waste
5. Use of the System
LIAISON
®
XS - Instruction for use Rev. H Page 5-43
Unload
Procedure
1. Pull the solid waste bin out of the LIAISON
®
XS system.
Figure 5–49: Solid waste Bin with EASY waste box in the instrument
2. Remove the eyelet out of the Solid Waste Bin (see Figure 5–50).
Figure 5–50: Box eyelet out of the Solid Waste Bin
3. Push the cap of the LIAISON
®
EASY Waste onto the EASY waste box
(see Figure 5–46).
Make sure that the un-folded portion of the cap is correctly inserted into the dedicated
portion of the box.
5. Use of the System
Page 5-44 LIAISON
®
XS - Instruction for use Rev. H
4. Insert the eyelet of the box inside the dedicated hole of the cap and lift the EASY
waste box before closing the cap (see Figure 5–51).
Figure 5–51: EASY Waste closing
5. Remove the LIAISON
®
EASY Waste from the Solid Waste Bin of the instrument.
6. Dispose the closed LIAISON
®
EASY Waste in the biological waste once pulled it
out of the drawer.
Load
Procedure
1. Store the cap of the EASY waste box. Keep it available to be used for closing the
EASY Waste box when full.
2. Place a new EASY waste box into the solid waste Bin. When inserting, observe
the direction of the arrow on the box.
Figure 5–52: Arrow direction on the EASY waste box
5. Use of the System
LIAISON
®
XS - Instruction for use Rev. H Page 5-45
3. Insert the solid waste bin with the EASY waste back into the instrument.
4. Check the Summary of the Status menu and tap on the Reset Button.
Figure 5–53: Reset Button in Solid Waste
5.5 Load Patient Samples or Controls and Assign Assays
In this section, it is described how patient samples or controls are loaded into the system
and how they can be assigned to one or several assays.
5.5.1 Load Patient Samples
Sample Preparation
Make sure that eyelet of the box is correctly folded into the solid waste bin.
See Biological safety in chapter 1.6.6.
Traceability of the Diagnostic Results
For maintaining traceability of the diagnostic results, the patient sample should be
handled according to the laboratories quality system as described in the local
requirements.
Samples Handling
For maintaining safety, the samples must fulfill the requested installation and operating
conditions as stated in the assay instruction for use.
Sample Area Flap closure
The sample area flap must be left open only for the time necessary to load sample racks.
Leaving the sample area flap open for more than 5’, the sample barcode reader will be
disabled; in this case, it would be necessary to close the sample area flap and open it to
make it work again.
5. Use of the System
Page 5-46 LIAISON
®
XS - Instruction for use Rev. H
Due to certain mechanical restrictions and safety precautions, the sample to be used on the
LIAISON
®
XS system must have the following characteristics:
• Human serum, urine or plasma may be used (sample matrix depends upon assay
intended use).
• The anticoagulants citrate, EDTA and heparin may be used (allowed anticoagulants
depend upon assay intended use).
• Blood should be collected aseptically by venipuncture, allowed to clot, and the
serum separated from the clot as soon as possible.
• Samples having particulate matter, turbidity, lipaemia, or erythrocyte debris may
require clarification by filtration or by centrifugation before testing.
• Grossly haemolyzed or lipaemic samples as well as samples containing particulate
matter or exhibiting obvious microbial contamination should not be tested.
• Check for and remove air bubbles before testing.
• Check that the sample volume is sufficient to run the required amount of tests
(as described in the “Instructions For Use” on the kits being used).
• In case of plasma gel separator containers, the amount of sample should be at
least 500 µL plus the volume required to run the test.
After all criteria have been observed concerning the sample quality, the samples must be
inserted into tubes and then into sample racks. The following procedure explains in detail
the proper steps for doing so.
Procedure
• Only load and unload racks if explicitly requested to do so.
• Only load and unload racks on the specified lanes.
• Check the correct transfer/input of all sample names.
• Remove all caps from the sample tubes.
Air Bubble Formation or Clotting
Air bubble formation or clotting of the samples must be avoided as these may alter the
liquid detection functionality and hence cause unreliable results. To avoid clots, the
samples should be treated accordingly (e.g. centrifuged) prior to the use in the
LIAISON
®
XS system.
Error at Loading/Unloading of Racks, Reagents and Samples
Improperly loaded or unloaded racks, reagents or samples can cause wrong results due
to incorrect pipetting activities.
Only tubes of the same type may be used for each rack, to avoid problems during the
aspiration of liquids. The tube type must be approved for the relevant rack.
Do not rotate bar-coded sample tubes after placement in sample racks. Rotating tubes
when placed in sample racks may cause damage to the bar-code and render the label
unfit for future usage.
Use only exact modelling of tubes and bottles to ensure correct tracking.
5. Use of the System
LIAISON
®
XS - Instruction for use Rev. H Page 5-47
1. Place the sample tubes in the sample racks.
○ Sample tube diameter:
Use only sample tubes according to the used rack type (see chapter 4.2.4.3).
○ Bar coded patient samples:
Make sure that the bar-code labels on the individual patient samples face right
so that they can be scanned by the bar-code reader when the rack is inserted.
○ Non bar coded patient samples or unreadable bar-code labels:
When using non bar coded sample tubes or tubes with unreadable bar codes,
the sample ID's (SID's) must be entered manually (see below). Note that the
SID manual entry practice is considered not state-of-art as a potential source of
sample mismatch, out of the system control, leading to wrong diagnostic results.
2. Open the sample loading bay flap.
The software will show automatically the Samples sub category tab of the
Loading main category tab. The barcode reader is positioned on the right side of
the Sample loading bay. The laser beam exits from an opening positioned on the
internal right side of the sample loading bay. The laser beam is orthogonal to the
internal right side surface.
3. Insert the first sample rack (carefully to avoid tipping over and spilling of bottles
or tubes) into the sample loading bay on the lane marked by the yellow flashing
SW LEDs on the sample display in the software. Place the rack in front of the
lane and then push evenly up to the limit stop (with the tippet in the contact
opening on the rear panel).
The rack bar codes and the individual sample tube bar codes are read. If the
rack has been inserted properly all the way, the lamp on the screen goes off for
this position, and starts flashing at the next position that can be loaded.
4. If the barcode reader was not able to read any barcode ID, an input box appears:
○ Look at the rack label letter (rack identifier) on the front of the rack.
○ Enter the rack identifier manually.
○ Tap on the OK button.
See Laser safety in chapter 1.6.4.
Always use the rack handle when pushing in the racks into the rack system or pulling
them out again.
Never load more than one rack at a time! For proper bar-code identification the racks must
be loaded one after another.
5. Use of the System
Page 5-48 LIAISON
®
XS - Instruction for use Rev. H
Figure 5–54: Samples Display
Table 5–7: Functions of the Samplessub category
Function Description
1,2,3,4 Lanes of the loading bay for sample racks.
• A SW LED reflects the rack status.
• Tap on a lane to show all samples in the table on the right side.
Controls Opens the control picklist and allow the selection of a control name.
The bar-code ID related to the selected control name is assigned to
the current (empty) SID field.
The Control button is disabled if the SID field is not empty.
Rack log The Rack Log field shows information about a loaded or selected
sample rack.
• Loading errors
• Positions without bar-code or unreadable bar-code
• SID problems (e.g. duplications)
Schedule Shows the Worklist tab to create or edit worklists for samples and
controls.
Standard buttons For standard buttons (e.g. arrow buttons, lock, Print) see chapter 6.3.
5. Use of the System
LIAISON
®
XS - Instruction for use Rev. H Page 5-49
Table 5–8: Columns of the loaded samples table
Column Description
! Shows an exclamation mark for high-priority samples (STAT).
Type Shows an empty cell for samples or a symbol for calibrators and
controls:
• Calibrators
• Controls
• Light check
SID
Shows the patient ID, calibrator ID or control ID. The SID is read via
bar-code scanner or entered by operator (if bar-code not present or
unreadable).
Notes:
The SID must be unique.
Two or more samples with the same SID are not allowed to be loaded
at the same time.
Use only the following characters:
• A - Z (a - z are converted to upper case for patient samples)
• 0 - 9
• blank space ( ), minus (-), dot (.), dollar sign ($), plus (+),
percent sign (%), number sign (#), ampersand (&), equal (=) and
slash (/) for patient ID
• minus (-) and slash (/) for control ID.
A SID may be 3 to 22 characters long and may not contain heading or
trailing spaces.
The SID of external calibrators begins with a predefined prefix
character and contains the assay abbreviation or article number.
The SID of controls may not begin with #.
Note
The SID field is write protected, if any of the following applies:
• the rack is in “Error”
• the SID was read via bar-code (and accepted, i.e. not deleted
because of duplication or illegal character)
• the Control button was pressed for that SID at least once since the
SID was recognized (i.e. un-pressing that button does not allow
typing, it's necessary to unload and reload the rack)
• either a workorder or a patient definition for that SID is present in
the work-database (visible in the sub category All of the main
category Results, see chapter 6.6.1).
Pending If assays are reassigned to the sample: Shows all assays in status
Placed or Failed for the sample.
In Process If assays are assigned to the sample: Shows all started assays in
status Scheduled, Active or Measured for the sample.
5. Use of the System
Page 5-50 LIAISON
®
XS - Instruction for use Rev. H
5. Note the Rack Log field for information about the loaded (or selected) sample
rack. The Rack Log field shows:
○ Loading errors
○ Empty positions (positions without tubes, without bar-coded tubes or with tubes
with unreadable bar-codes)
○ SID problems (e.g. duplications)
6. Tap on the rack shown and check the sample ID's in the SID column of the table.
Table 5–9: Symbols
7. Check all shown SID's of the loaded sample tubes.
An incorrect SID will be replaced by an empty field (check also the Rack Log):
If so:
○ Tap on the affected SID cell.
○ Enter the correct SID.
○ Repeat the steps for all incorrect SID's.
8. Load the other sample racks in the same manner.
9. Close the sample loading bay flap.
Light-Check must be loaded as ancillary reagent for the right pipettor and as sample for
the left pipettor.
Any sample beginning with the special characters (i.e. “#” or “$”) will be displayed as
control (if a control definition is available, otherwise the SID is considered invalid) or
calibrator, no matter if they will be treated as controls or calibrators or patient samples.
Symbol Description
Loaded sample tube with known SID.
Loaded sample tube without bar-code or unreadable bar code,
or
no tube loaded.
The SID is empty.
Sample in process.
Sample off-line, a clot detection or “NoLiquidFound” occurred since
last loading
(If a sample is off-line, unload it, check its status and reload again
when OK.)
A sample error occurred since last loading and at least one scheduled
aspiration has to be completed
A sample error occurred since last loading and no scheduled
aspiration has to be completed
Sample IDs should not contain heading and trailing spaces. The system will deny spaces
if entered manually via the on screen keyboard or read via bar code.
5. Use of the System
LIAISON
®
XS - Instruction for use Rev. H Page 5-51
5.5.1.1 Loading Error
It is possible to obtain an error while loading a sample rack.
Typical problems may include (but are not limited to):
• Damaged bar codes on the sample rack.
• The sample rack is inserted too fast or too slow. Ask local service support for a
tutorial about proper loading speed.
• The bar-code scanner of the sample loading bay is damaged.
Errors with sample racks will appear immediately.
• The Samples display of the LIAISON
®
XS software shows an Error note on the
loaded sample rack picture.
• The affected sample loading bay lane will be identified by a flashing LED on the
screen.
• The Rack Log on the Samples display shows an error message when that lane is
selected.
Troubleshooting:
• Remove the sample rack.
• Check and correct the bar-code labels.
• Insert the sample rack again.
• If the system cannot recognize the rack, check the bar-code scanner of the sample
loading bay with another sample rack, and call service if the error occurs again.
5.5.2 Assign Assays to the Patient Samples
Procedure
1. Tap on the Loading main category tab.
2. Tap on the Samples sub category tab.
3. Select a sample rack containing identified patient samples.
4. Tap on the Schedule button to assign assays to the patient samples.
Table 5–10: Functions
Function Description
Rack lane Shows the lane number of the selected sample rack.
This button serves as Select/ Unselect All button, forces
the Lock button to be closed. Tap on the arrow bottons
next to the Rack lane button to show another available
sample rack, and the sample list will be updated.
Samples list Shows all samples, calibrators, and controls which are
present in the selected rack.
Note: empty positions are not shown.
Standard buttons For standard buttons (e.g. arrow buttons, lock, Print) see
chapter 6.3.
5. Use of the System
Page 5-52 LIAISON
®
XS - Instruction for use Rev. H
Table 5–11: Columns of the rack samples table
Selection Group
The Selection group allows assigning assays (tests) to one or more samples.
Table 5–12: Functions of the Selection group
5. Use the arrows next to the Rack lane button to select the desired sample rack
lane.
6. Check the ! checkbox for all high-priority samples (STAT).
7. Tap on the desired row(s) in the table to select one or more samples.
Use the lock button to change the selection mode:
○ Opened lock: Only one sample entry can be selected (default).
○ Closed lock: It is possible to select more than one sample entry.
Column Description
Position Tube position in the rack.
Type Shows an empty cell for samples or a symbol for
calibrators, controls and light check.
SID Shows the sample ID, calibrator ID and control ID.
! Checkbox to assign high-priority to samples (STAT).
Function Description
Assay Selection in
Group
Assays are organized in groups. First it is necessary to
choose the assay group. After that it is possible to select
one or more assays.
The display of an assay shows its relation to the samples:
• Colour
○ Blue: The assay is assigned to sample(s).
○ Blue and Grey: The assay is assigned to at least
one selected samples
○ Grey: The assay is not assigned to sample(s).
• Shape
○ Solid: An integral for the assay is loaded.
○ Broken with two stripes: An integral for the assay
is not loaded or is not suitable for starting a test.
Profile Selection Enables to select a profile (contains several assays,
see chapter 6.8.5). Use the arrow buttons to show all
available profiles.
See chapter 6 for further details about the Schedule tab.
It is not possible to create a worklist selecting samples of different types.
It is possible to select and work up several patient samples. Additionally tap on the Lock
button to use the multiple selection function.
5. Use of the System
LIAISON
®
XS - Instruction for use Rev. H Page 5-53
8. Select an assay group in the Assay Selection in Group selection box in the
Selection sub tab.
9. Tap on the desired assay button to select one or more assays.
Use the arrows next to the assays to show all assays of the group.
Table 5–13: Assay status
10. Select a profile (contains several assays).
Use the arrows next to the profiles to show all profiles.
11. There is the possibility to assign one or more dilution factors to the assigned
assays in the Dilution group (see chapter 6.5.1.1).
12. There is the possibility to change the number of replicates to the assigned
assays in the Replicates group (see chapter 6.5.1.1).
13. Assign the other samples with assays in the same manner.
14. There is the possibility to specify patient personal information for the selected
patient sample in the Demographics group (see chapter 6.5.1.1).
15. Tap on the Store button to confirm the assignment.
The LIAISON
®
XS software returns to the Samples display and shows the
assigned assays in the Pending column.
Style Description
The assay is:
• currently not loaded on the machine
• not assigned to the selected sample(s)
The assay is:
• currently not loaded on the machine
• not assigned to all selected samples
The assay is:
• currently not loaded on the machine
• assigned to the selected sample(s)
The assay is:
• currently loaded on the machine
• not assigned to the selected sample(s)
The assay is:
• currently loaded on the machine
• not assigned to all selected samples
The assay is:
• currently loaded on the machine
• assigned to the selected sample(s)
As soon as a test is started, the status changes to grey (unselected) and may be assigned
again, even if the previous test is still running.
5. Use of the System
Page 5-54 LIAISON
®
XS - Instruction for use Rev. H
5.5.3 Load Controls and Assign to Assays
Preparation
Before the control is utilized by the user, it must first be prepared. The instruction on the
packaging box must be strictly followed.
• Check that the control volume is sufficient to run the required amount of tests
(as described in the “Instructions For Use” on the kits being used).
• Check the control specific Instruction For Use for control specific preparation.
Definition
Before controls can be used, the LIAISON
®
XS system must recognize the controls.
1. Tap on the Definitions main category tab.
2. Tap on the Controls sub category tab (see chapter 6.8.2).
3. For DiaSorin Italia S.p.A. controls, tap on the Scan button to open the Control
Scan Dialog.
For controls not provided with the 2 dimensional barcode, it is possible to define
the controls manually (see chapter 6.8.2).
4. Scan the bar-code of the control(s) with the provided external bar-code scanner.
5. Tap on the Ok button.
The LIAISON
®
XS system shows the control(s) in the controls table.
Loading
1. Load controls in the same way as patient samples. The upper case conversion is
not performed.
The field Type in the samples table shows a special symbol for controls.
2. When using non bar-coded control tubes or tubes with unreadable bar codes,
the control ID's (SID's)/control name must be chosen manually:
○ Select the desired position in the table.
○ Tap on the Controls button.
Only defined controls may be selected.
Note: in case two controls have been defined with the same name, the system
proposes the control that expires later.
○ Tap on the Add button.
The LIAISON
®
XS system adds the control ID from the chosen control name
automatically to the SID field.
Assigning
3. Assign assays to controls in the same way as patient samples
(see chapter 5.5.2).
Note the safety notes (see chapter 5.6).
Do note remove the external barcode scanner while operating.
If a control ID with no definition available is manually inserted with the #, it is considered
invalid.
Do not mix controls and patient samples at assay assignment.
5. Use of the System
LIAISON
®
XS - Instruction for use Rev. H Page 5-55
5.6 Integrals, Calibrators, Ancillary reagents
See Biological safety in chapter 1.6.6.
Do not use reagents that have not been authorized for the LIAISON
®
XS system!
It is prohibited under any circumstances to change the components of one reagent
to another even if the reagents contain the same lot number.
• Failure to follow instructions “on the box” may result in rapid deterioration of
reagent life or even immediate expiration of reagent components.
• Handling of Reagent Integrals must be followed according to the Assay IFU’s.
• In order to avoid system delays and damage to Disposable Tips all caps must be
removed from the reagent tubes or bottles before introduction into the
instrument.
• In order to avoid tipping over and spilling of bottles or tubes racks must be
inserted carefully.
• Only tubes or bottles of the same type may be used for each rack, to avoid
problems during the aspiration of liquids. The tube or bottle type must be
approved for the relevant rack.
• Always insert or remove the racks/integrals into the rack system with the handle.
• Never load more than one rack or integral at a time! For proper bar-code
identification the racks must be loaded one after the other, as indicated by the
LEDs on the screen.
• Bar-code labels on integrals, ancillary reagents and starters are not used in the
LIAISON
®
XS system.
• Note the Rack Log field for information about a loaded or selected rack
(e.g. errors, empty positions).
5. Use of the System
Page 5-56 LIAISON
®
XS - Instruction for use Rev. H
5.6.1 Load Integrals
Integral Preparation
Before an integral is utilized, it must first be prepared. The instructed markings on the
packaging box of the integrals must be strictly followed.
1. Remove the desired integral from the refrigerator keeping the integral in an
upright position at all times.
2. Open the shipping box containing the integral and remove the integral.
3. Visually inspect the integral vials for leaking at the membrane seals or
elsewhere. If the vials are found to be leaking, the local customer service should
be notified immediately.
4. Visually inspect the integral vials for bubbles. If bubbles are present the integral
can not be immediately used. The integral must either set until all bubbles
resolve, or the bubbles must be removed before usage (If bubbles are removed,
it is important not to cross contaminate vials).
5. Carefully remove the sealing flap of each vial by pulling the tab of the seal across
the membrane in a slow fluid motion (pull only the tab in order to prevent cross-
contamination of the reagent integral vials).
6. Remove all liquid from the surfaces of the membranes to prevent cross
contamination of the reagent integral vials.
7. Prepare the integral according to the related assay Instruction For Use.
Loading
1. Insert the integral into the integrated re-suspension tool and wait 30 seconds
(unless otherwise specified in kit IFU).
2. Open the reagent loading bay flap.
The software will automatically show the Reagents sub category tab of the
Loading main category tab.
Figure 5–55: Sub category Integrals
5. Use of the System
LIAISON
®
XS - Instruction for use Rev. H Page 5-57
Table 5–14: Functions of the Integrals sub category
Integrals Group
Table 5–15: Functions of the Integrals group
Details Group
Function Description
Calibrate Set the calibrator(s) of the selected integral in “Placed”
status.
In case the external calibrator(s) are not loaded, they are
set in “To Do” status.
For assays that share calibration within a kit lot, this
calibration will be available for all integrals of that kit lot,
no matter if loaded on-board or not.
If the integral is offline or disabled, the button is greyed
out.
Calibrations Shows the calibration dialog and selects the valid
calibration for the selected integral, if any.
Reset LLD Resets the liquid level of improperly offline vials for the
integral selected. It is necessary to unload and reload the
integral to allow the system to use it.
Disable/Enable If disabled the system will avoid using that integral. It has
no impact on the resuspension count down.
Info
Opens the Online Help and displays the documents
related to the selected integral.
If for the selected integral the related package is
not available, the download dialog is displayed
(see chapter 6.3.1.1).
Standard buttons For standard buttons (e.g. arrow buttons, lock, Print)
see chapter 6.3.
Function Description
1...10 Shows the integrals in the reagent loading bay lanes.
Tap on a loaded integral to show details.
Function Description
Abbreviation Abbreviation of the assay.
LIS alias Assay name on the LIS system.
Article Number Identification code of the selected integral that allows the
LIAISON
®
XS system to associate the integral to an
assay.
Kit Number Kit No number of the reagent integral.
Lot Number Lot number of the reagent integral.
Integral Layout
Parameter that allows the LIAISON
®
XS system to identify
the geometric characteristics of the integral.
5. Use of the System
Page 5-58 LIAISON
®
XS - Instruction for use Rev. H
Table 5–16: Functions of the Details group
3. Insert the first required integral into an empty lane of the reagent loading bay.
The LIAISON
®
XS software reads the RFID tag of the integral and shows the
information about the integral on the display.
4. Load the other required integrals in the same manner following steps 1-3.
5. Close the reagent loading bay flap.
6. Check all loaded integrals (see chapter 5.6.1).
Master Curve ID The ID of the calibration mastercurve used for this reagent
integral.
Expiry Date Date and time when the reagent integral will expire.
Note: this is the last day when that reagent integral is
allowed to be used.
On-board expiry date The calculated result obtained with that kit after that day
has elapsed will be provided with an indicating flag.
Check the on-board stability in the instruction for use of
each kit.
Integral Status Status of the integral availability:
• Online: The integral is usable
• Offline: The integral cannot be used. The abbreviation is
displayed in grey.
Possible reasons:
○ No liquid found.
○ The expiration date is exceeded.
○ The compatible assay protocol version is not loaded.
○ The integral has been disabled by user.
Calibration Status Status of the calibration (e.g. valid, not valid).
Original Number of
tests
Max. number of tests with a new integral.
Remaining Tests Remaining number of determinations for the selected
integral.
The number is updated (decremented by one) as soon as
the first aspiration event for a determination occurs.
Booked Tests Assigned but not started tests.
Available Tests Difference between Remaining Tests and Booked Tests.
Remaining
Calibrations
Remaining number of calibrations.
Function Description
5. Use of the System
LIAISON
®
XS - Instruction for use Rev. H Page 5-59
5.6.1.1 Check Integrals
Check the loaded integrals to ensure that:
• No load error (RFID reading error) occurred
• Integral to be used has a valid calibration status
• The number of remaining tests is sufficient
Figure 5–56: Integral
Table 5–17: Integral
No. Description
1) Lane number
2)
Assay name or error symbol
3) Calibration status (see table below)
4) Number of remaining tests
5) Agitation countdown time
The agitation countdown time starts with 15:00 min. and stops at
00:00 min. When it reaches 00:00, the integral can be used
(unless otherwise stated in the kit IFU).
5. Use of the System
Page 5-60 LIAISON
®
XS - Instruction for use Rev. H
Table 5–18: Calibration status
5.6.1.2 Particular Aspects of Loading Reagents in Combi-Assays
When inserting the reagent integral of a combi-assay followed by the assignment of this
assay to a sample, more measuring results can be obtained: those of the combi-sons and
the one of the combi-assay.
5.6.1.3 Lot Binding (Lot Locking)
An assay may require more than one integral for a run. The LIAISON
®
XS system shows
the binding between the integrals in the Reagents sub category. When selecting one
integral, the other compatible integrals will be marked with a blue frame.
5.6.1.4 Calibrate Integrals
A calibration cannot be started if any of the following occurs:
• another calibration is in status “Created” or “Ongoing” for the same integral
• another calibration is in status “Created” or “Ongoing” for another integral of the
same lot (if that assay shares the Working Curve)
• the calibrators are external and not present on board
• any required resource is detected as missing or empty; see chapter 6.12.3 to check
whether the available resources are sufficient.
Symbol Description
no symbol No specific symbol is shown if the integral has a valid
calibration.
A calibration is “Created” for the integral.
A calibration is “Ongoing” for the integral.
A red bar indicates that no valid calibration is present.
The symbol shall be considered effective only after the Finish time will be displayed
on the header (see chapter 6.4).
Refer to the safety notes (see chapter 5.6).
5. Use of the System
LIAISON
®
XS - Instruction for use Rev. H Page 5-61
Preparation
Before an integral is utilized, it must first be prepared. The instructed markings on the
packaging box of the integrals must be strictly followed.
1. Remove the desired integral from the refrigerator keeping the integral in an
upright position at all times.
2. Open the box containing the integral and remove the integral.
3. Visually inspect the integral vials for leaking at the membrane seals or
elsewhere. If the vials are found to be leaking, the local customer service should
be notified immediately.
4. Visually inspect the integral vials for bubbles. If bubbles are present the integral
can not be immediately used. The integral must either sit until all bubbles
resolve, or the bubbles must be removed before usage. (If bubbles are removed,
it is important not to cross contaminate vials).
5. Carefully remove the sealing flap of each vial by pulling the tab of the seal across
the membrane in a slow fluid motion (pull only the tab in order to prevent cross-
contamination of the reagent integral vials).
6. Remove all liquid from the surfaces of the membranes to prevent cross
contamination of the reagent integral vials.
7. Prepare the integral according to the related assay Instruction For Use.
Loading
1. Load the integral (see chapter 5.6.1).
2. Load additional calibrators in the same way as patient samples
(see chapter 5.5.1).
The field Type in the samples table shows a special symbol for calibrators.
3. Tap on the Integrals sub category tab of the Loading main category tab.
4. Select the affected integral in the Integrals sub category.
5. Tap on the Calibrate button.
The calibrators are set to “Placed” status.
6. Tap on the Start button.
When the calibration is completed, it will be automatically accepted or rejected.
7. When the calibration is completed, check if the calibration status of the affected
integral is valid.
If not, exchange the integral.
Calibration Report
• Select the affected integral in the Integrals sub category and tap on the Calibrations
button (available only if a valid calibration exists).
or
• Tap on the Calibrations sub category tab of the Results main category tab.
○ All calibrations (valid, failed, expired…) are stored
• A sample test can be performed without a valid calibration: in this case, only RLU
results will be given; the system will automatically assign a dose to all sample
results performed within the last 18 hours that have an RLU and not a dose.
5. Use of the System
Page 5-62 LIAISON
®
XS - Instruction for use Rev. H
5.6.2 Load Ancillary reagents
Preparation
Before the ancillary reagents are utilized by the user, they must first be prepared.
The preparation includes also the pre-storage. The instructed markings on the packaging
box must be strictly followed.
1. Remove the desired ancillary reagent from the refrigerator keeping it in an
upright position at all times.
2. Open the box containing the ancillary reagent and remove it.
3. Visually inspect the ancillary reagent for leaking. If any leaking is found, the local
customer service should be notified immediately.
4. Visually inspect the ancillary reagent for bubbles. If bubbles are present, the
ancillary reagent can not be immediately used. The ancillary reagent must either
set until all bubbles resolve, or the bubbles must be removed before usage.
5. Prepare the ancillary reagent according to the related assay Instruction For Use.
Loading
1. Open the reagent loading bay flap.
The software will show automatically the Integrals sub category tab of the
Loading main category tab.
2. Tap on the Ancillary sub category tab.
Figure 5–57: Sub category Ancillary
Refer to the safety notes (see chapter 5.6).
5. Use of the System
LIAISON
®
XS - Instruction for use Rev. H Page 5-63
Table 5–19: Functions of the Ancillary sub category
Table 5–20: Columns of the Ancillary sub category table
Off-line Status
If an ancillary reagent is off-line, the description text is displayed in grey.
Possible reasons:
• No liquid found
• The expiration date is exceeded.
• The ancillary reagent has a data recognition issue.
• The ancillary has been disabled by user.
3. Remove the ancillary rack (see chapter 4.2.5).
4. Place the ancillary reagent in the ancillary rack.
5. Insert the ancillary rack into the left lane of the reagent loading bay.
The LIAISON
®
XS software reads the RFID tag of the ancillary reagent and
shows the information on the display.
6. Close the reagent loading bay flap.
Function Description
Withdraw If it is necessary to remove the ancillary rack during a run,
press this button to suspend the pipettor access. Re-insert
the used ancillaries as soon as possible.
Note: this could lead to test failures.
Standard buttons For standard buttons (e.g. arrow buttons, lock, Print)
see chapter 6.3.
Column Description
No Position of the ancillary reagent in the ancillary rack.
Name Name of the ancillary reagent.
Art. No. Article number of the ancillary reagent.
Lot No. Lot number of the ancillary reagent.
Serial No. Serial number of the ancillary reagent.
Volume Available liquid volume in the bottle.
Exp. date Date and time when the ancillary reagent will expire.
Use by Onboard stability expiration date.
Status Status of the ancillary availability:
• Online: The ancillary is usable
• Offline: The ancillary cannot be used.
Bound lots If there is an entry, it is possible to use integrals of the
related assay with the reported lot number.
Some fields may be empty for ancillary reagents not to be used during a routine (i.e. Light
Check).
See chapter 5.5.1.1 for details about loading errors.
5. Use of the System
Page 5-64 LIAISON
®
XS - Instruction for use Rev. H
5.7 Start Worklist
After the checking, loading and assigning of all resources, the LIAISON
®
XS system can
start the preparation and evaluation of the samples.
Procedure
1. In Status Needs, tap on Calculate button and check if the needed resources
are available. If not, follow the procedure described in chapter 5.4.
2. Tap on the Start button in the Left Header.
The LIAISON
®
XS system starts with the worklist.
3. Tap on the Loading main category tab.
4. Tap on the Samples sub category tab.
Processed samples are marked with a symbol and the assay names are shown
in the In Process column of the table.
Figure 5–58: Samples display - running worklist
5. Use of the System
LIAISON
®
XS - Instruction for use Rev. H Page 5-65
5.8 Results
On the LIAISON
®
XS system, it is not necessary to wait for the entire processing to be
finished to view the results. As soon as the processing of one patient sample test,
calibration, or control is finished, the system generates the result for it.
The completed results can be accessed via the main category Results as well as its several
sub categories.
Table 5–21: Sub categories of the main category Results featuring completed results.
Sub category Description Procedure
Further
Details
All The sub category All shows all entries of
applied, started, and finished worklists.
- chapter 6.6.1
Worklist The sub category Worklist shows all
entries in “To Do” and “Placed” status
- chapter 6.6.2
Ongoing The sub category Ongoing shows all
entries in “Scheduled”, “Active” and
“Measured” status
- chapter 6.6.3
Done The sub category Done shows only
entries of finished worklists with status
“Done”.
chapter 5.8.1 chapter 6.6.4
Failed The sub category Failed shows only
entries of finished worklists with status
“Failed”.
chapter 5.8.2 chapter 6.6.6
Calibrations The sub category Calibrations shows
only calibration entries (either valid,
expired and failed calibrations).
chapter 5.8.3 chapter 6.6.7
Controls The sub category Controls shows the
results of the controls.
chapter 5.8.4 chapter 6.6.8
5. Use of the System
Page 5-66 LIAISON
®
XS - Instruction for use Rev. H
5.8.1 Results of Sample Tests (Status Done)
Use the sub category Done to show only sample entries of finished tests with status Done.
Procedure
1. Tap on the Results main category tab.
The LIAISON
®
XS software shows the sub category All.
2. Tap on the Done sub category tab.
Figure 5–59: Sub category Done
Function Description
Recalculate Recalculates the currently selected entries, using the most
recent valid calibration for the assigned assay. For Combi
Assays, if a Combi Son is selected, all results of the same
assay family are recalculated.
Delete Deletes one or more entries. The deleted entries are
moved to a separate database. For Combi Assays, if a
Son is selected, a pop-up ask the user to delete the entire
family or revoke the request.
Export Opens the Export display to export one or more entries to
a text file.
Archive Archives the currently selected entries. The archived
entries will be shown in the sub category Archived.
For Combi Assays, if a Son is selected, a pop-up ask the
user to archive the entire family or revoke the request.
Note: This button is available only if automatic archiving is
not enabled.
5. Use of the System
LIAISON
®
XS - Instruction for use Rev. H Page 5-67
Table 5–22: Functions of the Done sub category
Table 5–23: Standard columns of the “Done” samples table
3. Pay attention to the Flags column.
See chapter 5.8.5 for the used flag abbreviations.
Rerun Allows to repeat the test of one or more entries, opening a
selection display (see chapter 6.6.4.2).
For Combi Assays, if a Combi Father is selected, all
results of the same assay family are recalculated;
otherwise, only the selected Combi Son is rerun.
Note: the entries will be set either to “placed” (if the sample
is present on board) or to “to do” (if the sample is not
present on board).
Filter Opens the Select Filter display.
Details Opens the Result Details display for the selected entry.
Standard buttons For standard buttons (e.g. arrow buttons, lock, Print)
see chapter 6.3.
Function Description
The usage of the Recalculate feature may lead to modifications of already reported
results: use it only in accordance with laboratory procedures and local regulations.
Column Description
Sample ID Shows the sample ID.
Assay Shows the assigned assay.
Measured Result date and time.
Dilution Dilution factor for the result (only for diluted tests).
RLU Shows the raw result (in Relative Light Units).
Result Shows the dose result in user units.
Unit User units.
Qualitative Shows the qualitative label for the result (if defined for the
assay).
Flags List of all flags. For details about the flags see
chapter 5.8.5.
Dose calculation will be done automatically by the system as soon as a calibration is
successful performed, provided that the following conditions are met:
• the samples are successfully analysed but without a dose (i.e. in status Measured),
• the samples were run with the same kit (if the curve is not shared) or with the same lot
(if the curve is shared), and
• the samples, that have a RLU result, were run within the last 18 hours.
5. Use of the System
Page 5-68 LIAISON
®
XS - Instruction for use Rev. H
5.8.2 Results of Patient Sample Tests (Status Failed)
Use the sub category Failed to show only patient sample entries of finished tests with status
Failed.
Procedure
1. Tap on the Results main category tab.
The LIAISON
®
XS software shows the sub category All.
2. Tap on the Failed sub category tab.
Figure 5–60: Sub category Failed
Function Description
Recalculate Recalculates the currently selected entries, using the most
recent valid calibration for the assigned assay. For Combi
Assays, if a Combi Son is selected, all results of the same
assay family are recalculated.
Delete Deletes one or more entries. The deleted entries are
moved to a separate database. For Combi Assays, if a
Son is selected, a pop-up ask the user to delete the entire
family or revoke the request.
Archive Archives the currently selected entries. The archived
entries will be shown in the sub category Archive.
For Combi Assays, if a Son is selected, a pop-up ask the
user to archive the entire family or revoke the request.
Note: This button is available only if automatic archiving
is not enabled.
5. Use of the System
LIAISON
®
XS - Instruction for use Rev. H Page 5-69
Table 5–24: Functions of the Failed sub category
Table 5–25: Standard columns of the “Failed” samples table
3. Perform the next steps accordingly to the laboratory processes:
○ Details: Shows details for a selected sample entry.
○ Recalculate: Recalculates the currently selected entries.
○ Rerun: Reruns all or only the selected entry/entries.
5.8.3 Results of Calibrations
Use the sub category Calibrations to show only entries of all calibrations.
Procedure
1. Tap on the Results main category tab.
The LIAISON
®
XS software shows the sub category All.
2. Tap on the Calibrations sub category tab.
3. Pay attention to the Status column!
See chapter 6.6.7 for the used status abbreviations (Created, Ongoing, Failed,
Invalid, Valid, Expired, NotUsed, NotUsedLot, Disabled).
Rerun Reschedules one or more entries. For Combi Assays, if a
Combi Father is selected, all results of the same assay
family are recalculated; otherwise, only the selected
Combi Son is rerun.
Note: the entries will be set either to “placed” (if the sample
is present on board) or to “to do” (if the sample is not
present on board).
Filter Opens the Select Filter display.
Details Opens the Result Details display for the selected entry.
Standard buttons For standard buttons (e.g. arrow buttons, lock, Print)
see chapter 6.3.
Function Description
The usage of the Recalculate feature may lead to modifications of already reported
results: use it only in accordance with laboratory procedures and local regulations.
Column Description
Sample ID Shows the sample ID.
Assay Shows the assigned assay.
Measured Date Result date and time.
Dilution Factor Dilution factor for the result (only for diluted tests).
Flags List of all flags. For details about the flags see
chapter 5.8.5.
5. Use of the System
Page 5-70 LIAISON
®
XS - Instruction for use Rev. H
5.8.4 Results of Controls
Use the sub category Controls to show only entries of all controls.
Procedure
1. Tap on the Results main category tab.
The LIAISON
®
XS software shows the sub category All.
2. Tap on the Controls sub category tab.
3. Pay attention to the Flags column! (see chapter 5.8.5)
5.8.5 List of Flags
Each result flag may belong to one of two tables.
• If a flag from the ”invalidating flags” table is set, then the result is not reported;
• If a flag from the “indicating flags” table is set, then the result is reported.
The column “Applies to” defines to which Result the Flags are applied:
• R: Replicate,
• W: WorkOrder (entire sample test, in case of 2 or more replicates), and
• C: Combi Assay.
The Column “Inherits” defines which result inherits the flag.
Invalidating Flags
A flag on results indicates that something happened during the run that may have affected
the result on this sample.
The system will not report results in case of detected process anomalies.
Reported results may carry flags in order to inform users about the special conditions
under which that result was reported.
Not reported results carry flags in order to describe the process anomalies for which that
result was not reported.
Abbr. Description Explanation Applies to Inherits
*
Mechanical error A mechanical error occurred on the
system.
RW,C
*
Agitation speed out
of range
The magnetic particel agitation was
out of range while pipetted.
RW,C
*
No cuvette available No cuvette was available to process
the job.
RW,C
*
Liquid tank removed Wash Buffer or System Liquid
removed
RW,C
*
Waste tank full Processing aborted due to full waste
Tank.
RW,C
*
Disposable tip not
present
The system did not have disposable
tips available.
RW,C
S
Sample not present The sample was not found (tube not
present or offline).
RW,C
R
Ancillary not present A needed ancillary was not found
(vial not present or offline).
RW,C
5. Use of the System
LIAISON
®
XS - Instruction for use Rev. H Page 5-71
R
Reagent integral
not present
A needed integral was not found
(integral not present or offline).
RW,C
*
Washer aspiration
failure
An aspiration failure was detected in
the washer.
RW,C
*
Incubator
temperature out of
range
Incubator temperature was out of
range when the test was processed. RW,C
*
Starter reagent
temperature out of
range
Starter reagent temperature was out
of range when the test was
processed.
RW,C
*
Job scheduling
failure
A job scheduling failure occurred. RW,C
*
User requested abort The test was aborted as per user
request.
RW,C
*
Starter prime not
performed
System fails to execute priming
cuvette.
RW,C
*
Measurement
chamber error
The system detected an error in the
Reader.
RW,C
*
Starter dispense
control
Starter Volume Check after
Measurement failed
RW,C
*
Starter reagent
depleted
No Starter to perform Measurement
RW,C
*
Pipettor Wash Error An error during reagent pipettor
wash was detected
RW,C
*
Disposable tip pickup
failed
The system could not pick a
disposable tip assumed available.
RW,C
S
Sample integrity error An aspiration or dispense failure was
detected by the sample pipettor.
RW,C
R
Reagent integrity
error
An aspiration or dispense failure was
detected by the reagent pipettor.
RW,C
S
Pip no sample No or Not Enough sample liquid
found
RW,C
R
Pip no reagent No or Not Enough reagent liquid
found
RW,C
S Clot sample probe Clot in Sample RW,C
* Internal error Software Error RW,C
* High background Too high noise in the Reader RW,C
*
No mitigation No successful mitigation was
performed
RW,C
*
Invalid assay
sequence
Assay sequence not valid
RW,C
*
Aspiration plausibility
error
One aspiration did not occur in the
defined time slot.
RW,C
Abbr. Description Explanation Applies to Inherits
5. Use of the System
Page 5-72 LIAISON
®
XS - Instruction for use Rev. H
Table 5–26: List of invalidating flags
Indicating Flags
D
Overdiluted The sample was over diluted.
(Only for samples with sample
specific dilution)
RW,C
Z
Divided by zero For calculation of a combi assay
result a division by zero occurred
C
M
Math error Math error occurred while calculating
dose.
R,W,C W
*
Starter lot change A replicate could not start due to a
starter lot change meanwhile
occurred.
RW,C
X>
Son above assay
range
Any combi son is above the assay
range.
C
X<
Son below assay
range
Any combi son is below the assay
range.
C
XM
Combi Son
mathematical error
Any combi son has a math error in
dose calculation
C
Abbr. Description Explanation ApTo Inher
E
Reagent on board
stability expired
The used integral or ancillary has
the onboard expiration date
overdue.
RW, C
C
No calibration No usable calibration available to
calculate dose
R, W C
<
Below assay range The calculated dose is below the
assay range. If the assay range low
limit is not defined, than the
concentration of the first standard
may be used (unless it is equal to
zero).
R,W,C
>
Above assay range The calculated dose is above the
assay range. If the assay range high
limit is not defined, than the
concentration of the last standard
may be used.
R,W,C
NL
Below normal range The calculated dose is below normal
range (not for calibrators and
controls).
R,W,C
NH
Above normal range The calculated dose is above normal
range (not for calibrators and
controls).
R,W,C
QE
Control expired The control used was expired
(for control samples only)
RW,C
Abbr. Description Explanation Applies to Inherits
5. Use of the System
LIAISON
®
XS - Instruction for use Rev. H Page 5-73
Table 5–27: List of indicating flags
Flag Mask
For reporting purpose some flags mask some other flags, i.e.: the presence of a flag avoids
another flag of lower importance.
For example, a result with flag “S” is not provided with flag “C”, even if a valid calibration
was not available.
Combi Results
For combi assay results some flags reflected the presence of a flag into any combi son
results.
Q
Controls out of
manufacturer range
At least one RVC was not satisfied.
Controls (not defined as RVC)
run before that patient sample have
QH/QL flag. Based on last
performance of any control defined
for that assay.
Only for patient samples.
W,C
QL
QC below
manufacturer range
Controls below the Manufacturer
Range or outside the Assay Range,
if a Manufacturer Range is defined
(for control samples only).
W,C
QH
QC above
manufacturer range
Controls above the Manufacturer
Range or outside the Assay Range,
if a Manufacturer Range is defined
(for control samples only).
W,C
UL
QC below user range Controls below the User Range or
outside the Assay Range, if a
Manufacturer Range is defined
(for control samples only).
W,C
UH
QC above user range Controls above the User Range or
outside the Assay Range, if a
Manufacturer Range is defined
(for control samples only).
W,C
RM
Recalculated The result was recalculated upon
user request.
RW,C
& Caused rerun This result caused a rerun W,C
X&
Son caused rerun Any Combi Son of this Result caused
a rerun
C
X>
Son above assay
range
Any combi son is above the assay
range.
C
X<
Son below assay
range
Any combi son is below the assay
range.
C
XNH
Son above normal
range
A combi son was above the Normal
Range.
C
XNL
Son below normal
range
A combi son was below the Normal
Range.
C
Abbr. Description Explanation ApTo Inher
5. Use of the System
Page 5-74 LIAISON
®
XS - Instruction for use Rev. H
Table 5–28: Combi results flags
5.9 Routine errors
If an error occurs that could compromise the integrity of the system or could fail a significant
amount of results, the run is automatically stopped. A message box with a message
describing the error is displayed. Error messages have to be confirmed
Figure 5–61: Sub category Event Log
All errors and events can be shown in chapter 8.
The flag for a Combi Son... ...becomes the flag for its Combi Father.
Math error Son Math error
Below assay range Son Below assay range
Above assay range Son Above assay range
Below normal range Son Below normal range
Above normal range Son Above normal range
Caused rerun Son Caused rerun
Error messages are described in chapter 8.
If the error reoccurs, please call service.
5. Use of the System
LIAISON
®
XS - Instruction for use Rev. H Page 5-75
5.10 Unloading
It is possible to unload unused sample racks or integrals. The LIAISON
®
XS system shows
unused resources.
5.10.1 Unload Sample Racks
1. Observe the SW LEDS over the sample loading bay lanes on the screen.
2. If there are SW LEDs off, but the lanes are occupied, then open the sample
loading bay flap.
3. Hold the handle of an unused sample rack and push the sample rack against
backside. Note the audible click.
4. Remove the sample rack carefully.
5. Unload other unused sample racks.
6. Close the sample loading bay flap.
Disposal of Infectious Waste
Potential infectious material and all parts that may come in contact with potential
infectious material must be disposed according to the local and national provisions,
legislation and laboratory procedures. Handling of waste shall be done using appropriate
personal protective equipment (see chapter 1.6.6).
Error at Loading/Unloading of Racks and Samples
Improperly loaded or unloaded racks or samples may cause wrong results due to
incorrect pipetting activities.
• Only load and unload racks if explicitly allowed by corresponding SW LEDs on the
screen.
• Only load and unload racks on the specified lanes.
Use of Racks
Remove the racks carefully out to avoid tipping and spilling of bottles or tubes.
Always remove the racks by the handle.
Never unload more than one rack at the same time.
Unload all sample racks before shutting the LIAISON
®
XS system down.
5. Use of the System
Page 5-76 LIAISON
®
XS - Instruction for use Rev. H
Patient Samples:
Controls and Calibrators:
5.10.2 Unload Integrals
If the sample tubes are not empty and will be used at a later date:
• Cover and store the patient sample according to laboratory regulations/specifications.
If the sample tubes are empty:
Discard tubes or bottles in an appropriate manner.
If the control or calibrator is not empty:
• Place the appropriate cap on the control or calibrator.
• Place the control or calibrator in a tray in an upright position (if available).
• Place the tray into the refrigerator (see storage information in the control or calibrator
instruction).
• If a tray is not available, place the control or calibrator bottle into the refrigerator in a
secure upright position.
If the control or calibrator is empty:
• Discard the control or calibrator in an appropriate manner.
Use of Controls and Calibrators
Do not use controls or calibrators that have not been authorized for the LIAISON
®
XS
system environment.
Disposal of Infectious Waste
Potential infectious material and all parts that may come in contact with potential
infectious material must be disposed according to the local and national provisions,
legislation and laboratory procedures. Handling of waste shall be done using appropriate
personal protective equipment (see chapter 1.6.6).
Error at Loading/Unloading of reagent integrals
Improperly loaded or unloaded reagent integrals may cause wrong results due to incorrect
pipetting activities.
• Only load and unload reagent integrals if explicitly allowed by corresponding SW LEDs
on the screen.
Only load and unload reagent integrals on the specified lanes.
Use of Integrals
Remove integrals carefully out to avoid tipping and spilling of integrals.
5. Use of the System
LIAISON
®
XS - Instruction for use Rev. H Page 5-77
5.10.2.1 Proper Storage and Handling of Integrals
Store the integral according to the related Instruction For Use.
Do not remove integrals still in use.
Always remove the integrals by the handle.
• Look at the SW LEDs on the screen.
• If the SW LED is off, but the lane is occupied, then open the reagent loading bay flap.
• Hold the handle of the unused reagent integrals and remove it carefully keeping it in an
upright position.
• Close the reagent loading bay flap.
Never unload more than one integral at a time.
If the integral is not empty:
• Place the integral in an integral tray in an upright position (if available).
• Place the integral tray into the refrigerator (see storage information in the integral
instruction for use manual).
• If an integral tray is not available, place the integral into the refrigerator in a secure
upright position.
If the integral is empty:
Discard the integral in an appropriate manner.
Use of Integrals
Do not use integrals that have not been authorized for the LIAISON
®
XS system
environment.
Use of Integrals
It is prohibited under any circumstances to modify the integral setup.
5. Use of the System
Page 5-78 LIAISON
®
XS - Instruction for use Rev. H
5.10.3 Unload Ancillary Reagents
Disposal of Infectious Waste
Potential infectious material and all parts that may come in contact with potential
infectious material must be disposed according to the local and national provisions,
legislation and laboratory procedures. Handling of waste shall be done using appropriate
personal protective equipment (see chapter 1.6.6).
Error at Loading/Unloading of ancillary reagents
Improperly loaded or unloaded ancillary reagents can cause wrong results due to
incorrect pipetting activities.
• Only load and unload ancillary reagents if explicitly requested to do so.
Use of Ancillary Rack
Pull the ancillary rack carefully out to avoid tipping and spilling of bottles.
Do not remove ancillaries that are still in use.
Always remove the ancillary rack by the handle.
• Look at the SW LED in the ancillary loading page lane (lane “A”).
• If the SW LED is off, but the lane is occupied, then open the reagent loading bay flap.
• Hold the handle of the unused ancillary rack and remove it carefully keeping it in an
upright position.
Close the reagent loading bay flap.
If the ancillary reagent is not empty:
• Place the ancillary or reagent in a tray in an upright position (if available).
• Place the tray into the refrigerator (see storage information in the ancillary or reagent
instruction for use manual).
If a tray is not available, place the ancillary or reagent bottle into the refrigerator in a
secure upright position.
If the ancillary or reagent is empty:
Discard the ancillary reagent in an appropriate manner.
Use of Ancillary Reagents
Do not use ancillary reagents that have not been authorized for the LIAISON
®
XS system
environment.
5. Use of the System
LIAISON
®
XS - Instruction for use Rev. H Page 5-79
5.11 Shutdown/End of Day Activities
5.11.1 Procedure for system Shutdown and Wakeup
The following procedure shall be performed in case of long period of instrument inactivity
(more than 2 weeks).
The LIAISON
®
XS can be left on after the routine completion, paying attention to leave on
board the System Liquid tank above the red phase. The system automatically goes into a
“stand-by” condition after some time of inactivity.
Shutdown might be possible in case of long period of inactivity (more than 2 weeks).
The required procedure for the shutdown and restart of the system from long period is
described in the following paragraph 5.11.1.
Before starting the System Shutdown Maintenance task, 1.5 L of Cleaning Solution shall
be prepared according to chapter 7.3.
System
Shutdown
Maintenance
Task
1. Ensure that the instrument is not in “running” or “maintenance” status before
starting the maintenance;
2. Tap on the Maintenance main category and select the System Shutdown
Maintenance Task;
3. Tap on the “Perform” Button to start the System Shutdown Maintenance Task;
4. Follow the instructions described in the Maintenance Task.
System Wakeup
Maintenance
Task
1. Switch on the instrument according to chapter 5.3;
2. Ensure that the instrument is not in “running” or “maintenance” status before
starting the maintenance;
3. Tap on the Maintenance main category and select the System Wakeup
Maintenance Task;
4. Tap on the “Perform” Button to start the System Wakeup Maintenance Task;
5. Follow the instructions described in the Maintenance Task.
In case a system shutdown via main switch is needed, ensure to keep it unpowered for at
least 1 minute before switching it on again.
In case a forced shutdown is needed, the user shall push the Soft Power button for at
least 3 seconds.
5. Use of the System
Page 5-80 LIAISON
®
XS - Instruction for use Rev. H
6. Software Functions
LIAISON
®
XS - Instruction for use Rev. H Page 6-1
6 Software Functions
In this chapter, the complete LIAISON
®
XS software is described in detail. Hereby, the main
focus is not on the general context and the process but on a complete description of all
functions, buttons, lists etc. This chapter can therefore be considered as a reference book
for the LIAISON
®
XS software
6.1 Software Startup
On startup LIAISON
®
XS software perform a quick database check for data correctness.
There is no communication to or from the instrument until it is initialized the first time
manually with Stop Initialize.
The start screen shows a progress bar below the manufacturer name.
Figure 6–1: Opening the Login Screen
Software functions not described in this chapter are for field service engineers and
developers only. All other users do not have access rights for these special functions.
6. Software Functions
Page 6-2 LIAISON
®
XS - Instruction for use Rev. H
6.2 Login Screen
The Login Screen is displayed when the LIAISON
®
XS Software is started or the user is
logged out.
The Login Screen is displayed in Display Area only, the Left header and the Toggle Area
remain visible but disabled (no interaction possible).
Figure 6–2: Login Screen
Table 6–1: Login Screen
Function Description
Username Name of the user that wants to login
Password Each character is displayed as * and not logged as plain text.
Login Button Checks whether the user name and the password are valid.
• If User does not exist, a hint shall be given.
• If the Password is wrong, a hint shall be given.
• Otherwise the user shall be logged in.
6. Software Functions
LIAISON
®
XS - Instruction for use Rev. H Page 6-3
6.3 General
In this subchapter, functions that can be used in the complete LIAISON
®
XS software are
described.
Table 6–2: General functions
Function Symbol Description
Cancel Dismisses all changes, closes the dialog and
returns to the previous display.
Help Shows the Online Help (see chapter 6.3.1).
Multiselect Activate the multiselect function to select more
than one consecutive/non consecutive entry in a
list.
• Opened lock: Multiselect function is deactivated
(default)
• Closed lock: Multiselect function is activated
Selection of consecutive items is supported by
swiping a finger across them.
OK Confirms/saves all changes and returns to the
previous display.
Print Tap on this button to show the printer dialog
(see chapter 6.3.3).
Scroll buttons Jump to the first/last page (active in case of
multiple page documents).
Scroll buttons Jump to the previous/next page (active in case of
multiple page documents).
Scroll buttons Jump to the previous/next values (active in case of
multiple page documents).
Scroll buttons Jump to the previous/next values (active in case of
multiple page documents).
Search Searches for the entered text and shows the
results in the table (see chapter 6.3.2).
Store Confirms/saves all changes and returns to the
previous display.
Table sort order Sorts the rows of a table in ascending or
descending order.
Tap on a table headline to start the sorting.
After the sorting one of the arrows are shown next
to the headline.
Total records Shows the number of rows in the table.
6. Software Functions
Page 6-4 LIAISON
®
XS - Instruction for use Rev. H
6.3.1 Online Help
The Help button provides access to all operating instructions and information necessary to
run the system.
When selecting the Help button, the system Online help is shown.
Figure 6–3: Online Help
In some cases it is not possible to select another sub or main category. In this case a
function with separate tab (e.g. details) has been selected. Tap on the OK, Store, or
Cancel button to return to the sub category.
During time consuming operations typically involving a relevant amount of data, the
system time (reported on the left header, see chapter 6.4) may be frozen. Once the
operation has been concluded, the system will start again updating the system time.
6. Software Functions
LIAISON
®
XS - Instruction for use Rev. H Page 6-5
Table 6–3: Functions of the Online Help
6.3.1.1 Download
In User Manual, Quick Guide, Glossary and Trouble Shooting tabs:
Figure 6–4: Download dialog
Function Description
Search Searches for the entered text and shows the results.
Only alphanumerical characters are accepted (no special
characters): a-z, A-Z, 0-9
Download To send a request to the DiaSorin online repository for downloading
contents depending on the selected toggle.
• User Manuals for the current software version if the selected
toggle is any among: User Manual, Quick Guide, Glossary and
Trouble Shooting.
• Assay Protocol and accompanying documentation (e.g. IFU)
if the selected toggle is: Assay
• Plastics IFU, if the selected toggle is: Consumable
The DiaSorin online repository will reply to the request by matching
it with the available contents.
Acquire Opens a file selection Dialog and allows the user to import from the
main path of a connected USB device or from a connected network
folder instrument dedicated contents (e.g. packages containing User
Manuals, Assay Protocols) to be retrieved from the DiaSorin web
site.
Print Prints the current document on the default printer of Windows or as
a PDF file.
Back
Closes the Online Help and returns to the LIAISON
®
XS software
main screen.
6. Software Functions
Page 6-6 LIAISON
®
XS - Instruction for use Rev. H
Table 6–4: Download dialog
In Assay and Consumable tabs:
Figure 6–5: Download dialog
Function Description
IFU Language Specifies the User preference for the language of the User Manuals.
Default: the IFU language as defined in the System-Settings
(see chapter 6.9.5).
Note: the provided contents may not match with the specified
language in case it does not match with any of the DiaSorin
approved languages for the involved country.
Download Start the request for downloading the contents.
The system will manage the download of the contents in
background.
A dedicated message will inform that the download completes or in
case of troubles.
Standard Buttons For standard buttons (e.g. arrow buttons, lock, Print) see
chapter 6.3
6. Software Functions
LIAISON
®
XS - Instruction for use Rev. H Page 6-7
Table 6–5: Download dialog
6.3.1.2 Online Help Acquire
Figure 6–6: Online Help- Acquire
Function Description
Article No. Allows to specify the Article Number of the product.
Lot No. Allows to specify the Lot number of the product.
IFU Language Specifies the User preference for the language of the documents.
Default: the IFU language as defined in the System-Settings
(see chapter 6.9.5).
Note: the provided contents may not match with the specified
language in case it does not match with any of the DiaSorin
approved languages for the involved country.
Download Start the request for downloading the contents.
The system will manage the download of the contents in
background.
A dedicated message will inform that the download completes or in
case of troubles.
Standard Buttons For standard buttons (e.g. arrow buttons, lock, Print) see chapter 6.3.
6. Software Functions
Page 6-8 LIAISON
®
XS - Instruction for use Rev. H
Table 6–6: Online Help- Acquire
6.3.1.3 User Manual
The User Manual tab shows the online version of this manual.
6.3.1.4 Quick Guide
Short instructions to use the LIAISON
®
XS system are shown on the Quick Guide tab.
6.3.1.5 Glossary
The Glossary tab opens the User Manual at a given anchor/bookmark.
6.3.1.6 Trouble Shooting
Help regarding issues with the LIAISON
®
XS system is available through the
Troubleshooting tab. Trouble Shooting tab opens the User Manual at a given anchor/
bookmarks.
Function Description
File Selection
Path
Select a file for instrument import on an available path.
Import Import the select file.
Standard Buttons For standard buttons (e.g. arrow buttons, lock, Print) see
chapter 6.3.
6. Software Functions
LIAISON
®
XS - Instruction for use Rev. H Page 6-9
6.3.1.7 Assay
The Assay tab shows information about assays.
Figure 6–7: Online Help- Assay
Function Description
Article No. Article Number
Lot No. When selection changes, then Document and File Selection are
cleared.
Document Type Available values: IFU, MSDS, CoA and Other.
File Selection All files with extension pdf. When selection changes, the selected
file is displayed.
6. Software Functions
Page 6-10 LIAISON
®
XS - Instruction for use Rev. H
6.3.1.8 Consumables
The Consumables tab shows information about consumables.
Figure 6–8: Online Help- Consumables
Function Description
Article No. Article number of the consumables.
Lot No. When selection changes, then File Selection is cleared.
File Selection All files with extension pdf. When selection changes, the selected
file is displayed.
6. Software Functions
LIAISON
®
XS - Instruction for use Rev. H Page 6-11
6.3.1.9 Video
The Video tab allows visualization of video tutorials.
Figure 6–9: Online Help - Video
6.3.2 Sorting and Searching
This function allows the user to sort the table entries or to search for entries.
Table 6–7: General functions
Function Description
Video Selection Allows to select video files to be reproduced.
For Video tutorials availability, please contact your local support representative.
Control tab is currently not provided.
Function Symbol Description
Search Searches for the entered text on the primary sorted column
and shows the results in the table.
Only alphanumeric characters are accepted (no special
characters): a-z, A-Z, 0-9.
Table sort
order
Sorts the rows of a table in ascending or descending order.
Columns that do not support sorting will not show any arrow.
6. Software Functions
Page 6-12 LIAISON
®
XS - Instruction for use Rev. H
Sorting
To view the table contents, it is possible to sort the shown entries.
Procedure:
1. Tap on one of the table headlines to sort the complete table.
2. The entries will be sorted on the basis of the text in the selected column.
3. A small arrow next to the headline shows the sort order:
○ Ascending sort order All entries are sorted from 0 to 9 and A to Z
○ Descending sort order All entries are sorted from Z to A and 9 to 0
Examples
• Unsorted entries:
Table 6–8: Unsorted entries
• Selected: Column 1/ Sort order: Ascending
Table 6–9: Sort order: Ascending
• Selected: Column 1/ Sort order: Descending
Table 6–10: Sort order: Descending
For items where the logical content is more relevant than the alphabetical content, the sort
order may be not alphabetical but logical (e.g. the “Status” column for test results can be
sorted according to a pre-defined non alphabetical order that follows the natural sequence
of status for a test).
The sort function is case insensitive (e.g. the item “Sample_01” is equivalent to the item
“SAMPLE_01”).
Column 1 Column 2
Sec_1_ID_2 Failed
Doc_34_ID_5 Done
Sec_1_ID_5 Failed
Sec_1_ID_22 ToDo
Column 1 Column 2
Doc_34_ID_10 Done
Sec_1_ID_2 Failed
Sec_1_ID_22 ToDo
Sec_1_ID_5 Failed
Column 1 Column 2
Sec_1_ID_5 Failed
Sec_1_ID_22 ToDo
Sec_1_ID_2 Failed
Doc_34_ID_10 Done
6. Software Functions
LIAISON
®
XS - Instruction for use Rev. H Page 6-13
• Selected: Column 2/ Sort order: Ascending
Table 6–11: Sort order: Ascending
Searching
As the system is used the result and events table’s entries will increase. To find particular
entries it is possible to search for these entries.
Figure 6–10: Search entry field
Procedure:
1. Tap on one of the table headlines to select the used column for the search
process.
2. Select the Search field.
3. Enter a text to search for. Note that all search results must begin with this text.
4. Tap on the Enter key to close the keyboard from screen.The LIAISON
®
XS
software shows the first entry of the found entries. If it was already visualized,
nothing on the page changes, otherwise the system scrolls the page to the first
matching entry.
5. Use the scroll buttons to look for the other found entries.
Column 1 Column 2
Sec_1_ID_22 ToDo
Doc_34_ID_10 Done
Sec_1_ID_2 Failed
Sec_1_ID_5 Failed
The search function shows always all entries. The function jumps entirely to the first entry
of the found entries.
According to the sort order, the first found entry is the topmost entry in ascending order.
The last entry is the topmost entry in descending order.
6. Software Functions
Page 6-14 LIAISON
®
XS - Instruction for use Rev. H
Examples
• Entries:
Doc_34_ID_10
Doc_39_ID_2
Sec_1_ID_5
Sec_1_ID_5
Sec_2_ID_7
Sec_2_ID_9
Sec_3_ID_4
• Search text: Sec_
• First entry found: Sec_1_ID_5
• Search text: Sec_2
• First entry found: Sec_2_ID_7
• Search text: (empty)
• First entry found: Doc_34_ID_10
6.3.3 Print Reports
It is possible to print the information (e.g. results, events, or assays) reported by the
LIAISON
®
XS software.
1. Select desired entries.
2. Tap on the Print button.
LIAISON
®
XS software shows an adapted dialog.
Figure 6–11: Print Report dialog (e.g. result report)
3. Select the print options:
• Selected Records: Prints only the selected entries
• All Records: Prints all entries currently present on the page list. If a filter is applied
before the print then the print will be applied the entries matching the filter criteria.
6. Software Functions
LIAISON
®
XS - Instruction for use Rev. H Page 6-15
• Printer Selection:
Allows to select between the “Default Printer” (Windows Default Printer) and
“Portable Document Format Printer”.
If the “Portable Document Format Printer” is selected, the user can select via
“File Selection Dialog” (“...” button) where to print the file.
Figure 6–12: File selection dialog
• Reports allows to select the print layout.
4. Tap on the Print button.
In case the printer queue should be deleted, it is necessary to interact with the printer
itself, as the system does not allow access to the operating system functionalities related
to the management the printer.
6. Software Functions
Page 6-16 LIAISON
®
XS - Instruction for use Rev. H
6.3.4 Available Paths
The system supports the use of local and network paths and USB devices for the following
functionalities:
• results export
• print (in PDF)
• backup copy
• auto-backup
• import Assay Protocols
• import and export of other Definition files (e.g. controls, groups)
• acquire from the Online help
• QC files export
6.4 Left header
Figure 6–13: Left header
Local folder can be accessed only by DiaSorin authorized personnel
6. Software Functions
LIAISON
®
XS - Instruction for use Rev. H Page 6-17
Function Description
Instrument and Company logo
Stop Calls the STOP Menu Dialog with:
• Abort All
• Resume
• Shutdown
• Initialize
Date Shows the current date.
Time Shows the current time.
User Shows the currently logged-in user.
Status Current system status
Start Starts a routine or adds to an ongoing routine. Enabled if the
system is in (Standby, Ready or Running) and jobs can be
started due to system module status.
If Starters and/or Wash Buffer are not primed, then Starters
and/ or Wash Buffer are automatically primed before schedule.
Cycle Shows the total number of operativity cycles for the instrument.
Finish time Estimated finish time of ongoing routine (±20 seconds).
Version
Release version of the LIAISON
®
XS software including
Service Pack, if applicable.
Serial Number Serial number of the instrument.
Indication for the LIS connectivity/activity.
A sign in the right lower corner means:
• Disabled
• Enabled
• Data Transfer
• Data Transfer, Error
6. Software Functions
Page 6-18 LIAISON
®
XS - Instruction for use Rev. H
Table 6–12: Functions of the Left Header
Indication for remote connectivity/activity. A sign in the right
lower corner means:
• Disabled
• Enabled
• Data Transfer
• Data Transfer, Error
Help Gives access to the On-line help.
Function Description
6. Software Functions
LIAISON
®
XS - Instruction for use Rev. H Page 6-19
Status Description
Disconnected/
Not initialized
The system is not initialized or the user has requested the
system to perform a diagnostic task: if the instrument is
connected, the system can be initialized upon pressure of the
Init button from the STOP Menu.
Note: this is a non functional status. As long as the system
stays in this status, there is no guarantee about the system
hardware functionalities, including (but not limited to) reagent
cooling, magnetic particles re-suspension, cuvettes movement.
Initializing The system performs all actions required for mechanical
initialization of all modules (e.g. from un-powered start or by
user request). The database integrity is also checked.
Standby All modules are operational, but no tests are running.
All subsystem temperatures are maintained at specified
temperatures. LIAISON
®
XS software allows starting a new
run: the system will take care of performing the necessary
activities (including primes). In Standby mode the system
supports loading of reagent integrals, ancillaries, samples and
plastic consumables in the drawer.
Maintenance This status is displayed when:
1. The user requested a routine while the system was in
Standby status: the system performs automatically the
priming procedures.
2. The user requested a maintenance task: the system
performs the foreseen maintenance activities.
3. The user requested a Resume: the system performs
automatically the priming procedures and the system
reaches the status Ready.
4. The user pressed the button Fill incubator.
5. The system periodically performs pipettor primes with
System Liquid.
Ready The system is considered ready for assay processing.
The LIAISON
®
XS software allows starting a new run.
The LIAISON
®
XS system returns into Ready mode when the
run is finished and can be started again after test scheduling.
After a predefined timeout, the system will return in Standby
mode.
Running
The LIAISON
®
XS system is performing tests.
New tests can also be started while the system is in Running
mode.
Halted A fatal error occurred and all activities are stopped.
The previous state is not recoverable.
The Halted mode can be reached from all other states.
All ongoing tests will be failed.
Note: this is a non functional status. As long as the system
stays in this status, there is no guarantee about the system
hardware functionalities, including (but not limited to) reagent
cooling, magnetic particles re-suspension, cuvette movement.
6. Software Functions
Page 6-20 LIAISON
®
XS - Instruction for use Rev. H
6.4.1 Stop Menu
Figure 6–14: Stop Menu
Table 6–13: Functions of the STOP Menu
Function Description
Abort All Aborting all jobs shall:
• stop (fail) all ongoing jobs within few cycles
• put all not started (scheduled) jobs to Placed
• allow to start a new routine without Resume
Resume Changes the System Status from Standby to Ready and
performs the priming procedures.
Shutdown Switches off the Software and the Deskshield is prompted.
Initialize
Initializes the System.
Supported smoothly in Ready, Standby, Halted, Not initialized,
Disconnected.
During Initialization the system needs:
• Liquid waste tank
• Solid waste drawer
loaded on-board.
Cancel Closes the STOP Menu and returns without any changes to the
previous display.
While the STOP Menu is in the foreground the run is not stopped.
6. Software Functions
LIAISON
®
XS - Instruction for use Rev. H Page 6-21
6.5 Main Category Loading
With the main category Loading, the LIAISON
®
XS system can be completely loaded and
unloaded with samples, integrals and ancillaries. In addition to the loading/unloading,
samples can be assigned to assays via the subcategory Samples.
The status of each lane (both for samples and reagents bay) is indicated by a SW LED:
Table 6–14: SW LED status
6.5.1 Sub Category Samples
The subcategory Samples allows the loading and unloading of sample racks. For every
sample tube in the racks, there is the possibility to assign a distinct identification number.
This number is either read via bar-code scanner or entered manually. Additionally, one or
more assays can be assigned to every sample. After the starting of these assays/tests, it is
indicated which samples are being processed.
The samples table shows all positions of the selected rack.
Figure 6–15: Sub category Samples
SW LED status Description
ON The resource is currently being used and cannot be removed
OFF • The resource is not used and can be removed
• The lane is empty (flap close)
Slow flashing The lane can be used to load the resource (flap open)
Fast flashing The resource has not been recognized
6. Software Functions
Page 6-22 LIAISON
®
XS - Instruction for use Rev. H
Table 6–15: Functions of the Samples sub category
Figure 6–16: Control pick-list
Risk of wrong test assignment
When Schedule button is pressed, any SIDs selection in the sub category Samples
is not maintained. The SID selection must be repeated in the Schedule Display
(see Figure 6–18).
Improper test assignment may occur!
Function Description
1,2,3,4 Lanes of the loading bay for sample racks.
• A SW LED reflects the rack status.
• Tap on a lane to show all samples in the table on the right side.
Control Opens the control pick-list and allow the selection of one of the
currently defined control names (see figure 6–16). The control ID
associated to the control name with the latest expiry date is
assigned to the current (empty) SID field.
The Control button is disabled if the SID field is not empty.
Rack log The Rack Log field shows information about a loaded or selected
sample rack.
• Loading errors
• Positions without bar-code or unreadable bar-code
• SID problems (e.g. duplications)
Schedule Shows the Worklist tab to create or edit worklists for samples and
controls (see chapter 6.5.1.1 and 6.5.1.2).
6. Software Functions
LIAISON
®
XS - Instruction for use Rev. H Page 6-23
In case of loading errors, the rack lane is displayed with a red exclamation mark:
Figure 6–17: Sample rack in error
6. Software Functions
Page 6-24 LIAISON
®
XS - Instruction for use Rev. H
Table 6–16: Columns of the samples table
Column Description
! Shows an exclamation mark for high-priority samples (STAT).
Type Shows an empty cell for samples or a symbol for calibrators, controls
and light check:
• Calibrators
• Controls
• Light check
SID
Shows the patient ID, calibrator ID or control ID. The SID is read via
bar-code scanner or entered by operator (if bar-code not present or
unreadable).
Notes:
The SID must be unique.
Two or more samples with the same SID are not allowed to be
loaded at the same time.
Use only the following characters:
• A - Z (a - z are converted to upper case for patient samples)
• 0 - 9
• blank space ( ), minus (-), dot (.), dollar sign ($), plus (+), percent
sign (%), number sign (#), ampersand (&), equal (=) and slash (/)
for patient ID
• minus (-) and slash (/) for control ID.
A SID may be 3 to 22 characters long and may not contain heading
or trailing spaces.
The SID of external calibrators begins with a predefined prefix
character and contains the assay abbreviation or article number.
The SID of controls may not begin with #.
Note
The SID field is write protected, if any of the following applies:
• the rack is in “Error”
• the SID was read via bar-code (and accepted, i.e. not deleted
because of duplication or illegal character)
• the Control button was pressed for that SID at least once since
the SID was recognized (i.e. un-pressing that button does not
allow typing, it's necessary to unload and reload the rack)
• either a workorder or a patient definition for that SID is present in
the work-database (visible in the sub category All of the main
category Results, see chapter 6.6.1).
Pending If assays are assigned to the sample: Shows all assays in status
Placed or Failed for the sample.
In Process If assays are assigned to the sample: Shows all started assays in
status Scheduled
, Active or Measured for the sample.
6. Software Functions
LIAISON
®
XS - Instruction for use Rev. H Page 6-25
Table 6–17: Symbols of the samples
6.5.1.1 Worklist Tab- for patient samples
The Worklist tab enables the assignment between samples/controls and assays.
This section describes the assignment for patient samples.
Figure 6–18: Schedule display for patient samples
Symbol Description
Loaded sample tube with known SID.
Loaded sample tube without bar-code or unreadable bar code,
or
no tube loaded.
The SID is empty.
Sample in process.
Sample off-line, a clot detection or “No Liquid Found” occurred since last
loading.
(If a sample is off-line, unload it, check its status and reload again when OK.)
A sample error occurred since last loading and at least one scheduled
aspiration has to be completed.
A sample error occurred since last loading and no scheduled aspiration has
to be completed.
Light check for the left arm must be loaded as sample.
Light check for the right arm must be loaded as ancillary reagent.
6. Software Functions
Page 6-26 LIAISON
®
XS - Instruction for use Rev. H
Table 6–18: Functions of the rack samples table
Table 6–19: Columns of the rack samples table
Function Description
Rack lane Shows the lane number of the selected sample rack.
This button serves as Select/ Unselect All button, forces the
Lock button to be closed. Tap on the arrow buttons next to the
Rack lane button to show another available sample rack, and
the sample list will be updated.
Samples list Shows all samples, calibrators, and controls which are present
in the selected rack.
Note: empty positions are not shown.
Standard buttons For standard buttons (e.g. arrow buttons, lock, Print) see
chapter 6.3.
Column Description
Position Tube position in the rack.
Type Shows an empty cell for samples or a symbol for calibrators,
controls and light check.
SID Shows the sample ID, calibrator ID and control ID.
! Checkbox to assign high-priority to samples (STAT).
It is not possible to create a worklist for patient and control samples at the same time.
Select samples separately from controls.
Use the Lock button to use the multiple selection function (only for patient samples).
6. Software Functions
LIAISON
®
XS - Instruction for use Rev. H Page 6-27
Selection Group
The Selection group allows the user to assign assays (tests) to one or more samples.
Table 6–20: Functions of the Selection group
Table 6–21: Assay status
Function Description
Assay Selection
in Group
Assays are organized in groups. First it is necessary to choose
the assay group. After that it is possible to select one or more
assays.
The display of an assay shows its relation to the samples:
• Colour
○ Blue: The assay is assigned to sample(s).
○ Blue and Grey: The assay is assigned to at least one
selected samples
○ Grey: The assay is not assigned to sample(s).
• Shape
○ Solid: An integral for the assay is loaded.
○ Broken with two stripes: An integral for the assay is not
loaded or is not suitable for starting a test.
Profile Selection Enables to select a profile (contains several assays, see
chapter 6.8.5). Use the arrow buttons to show all available
profiles.
Style Description
The assay is:
• currently not loaded on the machine
• not assigned to the selected sample(s)
The assay is:
• currently not loaded on the machine
• not assigned to all selected samples
The assay is:
• currently not loaded on the machine
• assigned to the selected sample(s)
The assay is:
• currently loaded on the machine
• not assigned to the selected sample(s)
The assay is:
• currently loaded on the machine
• not assigned to all selected samples
The assay is:
• currently loaded on the machine
• assigned to the selected sample(s)
As soon as a test is started, the status changes to grey (unselected) and may be assigned
again, even if the previous test is still running.
6. Software Functions
Page 6-28 LIAISON
®
XS - Instruction for use Rev. H
Demographics Group
The Demographics group allows the user to enter or view detailed information about one
selected sample.
Figure 6–19: Schedule Display Demographics group
Function Description
Sample ID Shows the sample ID (it is not possible to edit the sample ID).
Patient ID ID of the patient.
First name First name of the patient.
Initials Patient name initials.
Last name Family name of the patient.
Date of birth Date of birth of the patient.
Patient location Location of the patient.
Sender Name or code of the doctor. Allows selecting among a pre-
defined list of senders.
Sex Gender of the patient (Female, Male, or Unknown).
Detailed information of the Demographics group is only shown if the user has the access
right Patient Privilege. The visible data to every user are Patient ID, Patient location
and Sender.
Demographic data are not shown and cannot be edited in case for the same sample ID
different data are found among the results which are not in Done or Failed status.
Demographic data cannot be edited in case they are received from LIS.
6. Software Functions
LIAISON
®
XS - Instruction for use Rev. H Page 6-29
Dilutions Group
After having assigned assays to a sample, the Dilutions group allows the user to view and
change dilution work orders for the corresponding sample(s)/assay(s).
Figure 6–20: Schedule Display Dilutions group
Table 6–22: Functions of the Dilutions group
Function Description
Selected Assay(s) Shows all selected assay(s).
Note: for combi assays, the combi fathers or the combi sons will
be shown, depending on specific assays.
Available Dilutions Shows all available dilution factors.
Note: for combi assays, it may be not possible to select more
than one dilution or undiluted.
6. Software Functions
Page 6-30 LIAISON
®
XS - Instruction for use Rev. H
Replicate Group
After having assigned assays to a sample, the Replicate group allows to define a number
of replicates different from the default number (indicated in the assay file), up to 20.
The replicates can only be increased compared to the default value.
Figure 6–21: Worklist tab- Replicates Group
Table 6–23: Functions of the Replicate tab
Column Description
Assay Name of the assay.
Available Replicates Shows all available replicate values.
For combi assays, the system may show either the replicates for the combi father or the
combi sons.
6. Software Functions
LIAISON
®
XS - Instruction for use Rev. H Page 6-31
6.5.1.2 Worklist Tab- for control samples
The Worklist tab enables the assignment between patient samples/controls and assays.
This section describes the assignment for controls.
Figure 6–22: Worklist tab
Table 6–24: Functions
Table 6–25: Columns of the rack samples table
Function Description
Rack lane Shows the lane number of the selected sample rack.
This button serves as Select/ Unselect All button, forces the
Lock button to be closed. Tap on the arrow buttons next to the
Rack lane button to show another available sample rack, and
the sample list will be updated.
Samples list Shows all samples, calibrators, and controls which are present
in the selected rack.
Note: empty positions are not shown.
Standard buttons For standard buttons (e.g. arrow buttons, lock, Print) see
chapter 6.3.
Column Description
Position Tube position in the rack.
Type Shows an empty cell for samples or a symbol for calibrators,
controls and light check.
SID Shows the sample ID, calibrator ID or control ID.
! Checkbox to assign high-priority to samples (STAT).
6. Software Functions
Page 6-32 LIAISON
®
XS - Instruction for use Rev. H
Selection Group
The Selection group allows the user to assign assays to a control.
Table 6–26: Functions of the Selection group
Table 6–27: Assay status
It is not possible to create a worklist for selected samples and controls at the same time.
Select samples separately from controls.
The Lock button to use the multiple selection function is not supported for controls.
Function Description
Assay Selection Assays are organized in groups. First it is necessary to choose
the assay group. After that it is possible to select one or more
assays.
The display of an assay shows its relation to the samples:
• Colour
○ Blue: The assay is assigned to sample(s).
○ Grey: The assay is not assigned to sample(s).
• Shape
○ Solid: An integral for the assay is loaded.
○ Broken with two stripes: An integral for the assay is not
loaded or is not suitable for starting a test.
Control Details The Control Details section shows the Control ID, Control
Name, Control Lot and Expiration Date for the selected control.
Style Description
The assay is:
• currently not loaded on the machine
• not assigned to the selected sample
The assay is:
• currently not loaded on the machine
• assigned to the selected sample
The assay is:
• currently loaded on the machine
• not assigned to the selected sample
The assay is:
• currently loaded on the machine
• assigned to the selected sample
As soon as a test is started, the status changes to grey (unselected) and may be assigned
again, even if the previous test is still running.
6. Software Functions
LIAISON
®
XS - Instruction for use Rev. H Page 6-33
Controls Group
The Control group allows the user to select a particular reagent integral and/or ancillary for
the ordered control tests.
Figure 6–23: Worklist tab - Controls group
6. Software Functions
Page 6-34 LIAISON
®
XS - Instruction for use Rev. H
Table 6–28: Functions of the Control group
Function Description
Sample ID The sample ID (i.e. the content of the bar-code).
Name The name of the control.
Lot No. The control lot number.
Expiry The control expiration date.
Assay The list of all assays that have been assigned to that control in
the Selection Group.
Note: select an assay to use the “These kits/ancillaries” option for
that assay.
Range The expected concentration range in user units.
Any kit/ These kits
Any ancillary/
These ancillaries
When Any kit/ancillary is selected, then the system will decide
which integral to use to run the control.
When These kits/ancillaries is selected, then it is possible to
decide and pick one or more integrals/ancillaries from the integral
list for the assay selected in the Assay list. The selected
integrals/ancillaries will be used to run that control.
If no integral/ancillary is loaded, then Any kit will be selected and
These kits is disabled.
All/None If not all inserted kits/ancillaries are selected, then this button
selects all.
If all are selected, then this button unselects all.
In any case, the option These kits/ancillaries will become
selected.
Lot No. The lot number of each integral/ancillary that is loaded for the
selected assay.
Kit No. The kit number of each integral that is loaded for the selected
assay.
Lane The lane number where each integral is loaded for the selected
assay.
Tests The number of available determinations of each integral that is
loaded for the selected assay.
Article No. The article number of each ancillary that is loaded for the
selected assay.
Serial No. The serial number of each ancillary that is loaded for the selected
assay.
Position The position number where each ancillary is loaded for the
selected assay.
Volume The volume available for each ancillary that is loaded for the
selected assay.
6. Software Functions
LIAISON
®
XS - Instruction for use Rev. H Page 6-35
6.5.2 Sub Category Ancillaries
The sub category Ancillaries shows the ancillary reagents that are currently loaded on the
instrument.
Figure 6–24: Sub category Ancillary
Table 6–29: Functions of the Ancillary sub category
Function Description
Withdraw If it is necessary to remove the ancillary rack during a run, press
this button to suspend the pipettor access (notified by the SW LED
switched off). Re-insert the used ancillaries as soon as possible.
Note: this could lead to test failures. If the ancillary removed was
still necessary to the system, it will be displayed as greyed out.
Disable Sets the selected ancillary not suitable for starting a test
(displayed as greyed out)
Standard buttons For standard buttons (e.g. arrow buttons, lock, Print) see
chapter 6.3
No Position of the ancillary reagent in the ancillary rack.
Name Name of the ancillary reagent.
Art. No. Article number of the ancillary reagent.
Lot No. Lot number of the ancillary reagent.
Serial No. Serial number of the ancillary reagent.
Volume Available liquid volume in the bottle.
Exp. date Date and time when the ancillary reagent will expire.
Use by Onboard stability expiry date.
Status Status of the ancillary availability:
• Online: The ancillary is usable
• Offline: The ancillary cannot be used.
Bound lots If there is an entry, it is possible to use integrals of the related
assay with the reported lot number.
6. Software Functions
Page 6-36 LIAISON
®
XS - Instruction for use Rev. H
Off-line Status
If an ancillary reagent is off-line, the descriptive text is displayed in grey.
Possible reasons:
• No liquid found.
• The expiration date is exceeded.
In case of data recognition issue, the ancillary is displayed with a red exclamation mark:
Figure 6–25: Ancillary in error
6. Software Functions
LIAISON
®
XS - Instruction for use Rev. H Page 6-37
6.5.3 Sub Category Integrals
The sub category Integrals can be divided into the Integrals group (in the right part)
showing the reagent integrals that are currently loaded on the instrument, and into the
Details group displaying detail information for any integral that is currently selected.
Figure 6–26: Sub category Integrals
Table 6–30: Symbols of the Calibration Status
Symbol/Status Description
Invalid calibration
Ongoing calibration
Created calibration
no symbol No specific symbol is shown if the integral has a valid calibration.
6. Software Functions
Page 6-38 LIAISON
®
XS - Instruction for use Rev. H
Table 6–31: Functions of the Integrals sub category
Figure 6–27: Integral disabled
Function Description
Info
Opens the Online Help and displays the documents related to the
selected integral.
If for the selected integral the related package is not available,
the download dialog is displayed (see chapter 6.3.1.1).
Disable/Enable If disabled the system will avoid using that integral
(see Figure 6–27). It has no impact on the resuspension
count down.
Reset LLD Resets the liquid level of improperly offline vials for the integral
selected. It is necessary to unload and reload the integral to allow
the system to use it.
Calibrations Shows the calibration dialog and selects the valid calibration for
the selected integral, if any.
Calibrate Set the calibrator(s) of the selected integral in “Placed” status.
In case the external calibrator(s) are not loaded, they are set in
“To Do” status.
For assays that share calibration within a kit lot, this calibration
will be available for all integrals of that kit lot, no matter if loaded
on-board or not.
If the integral is offline or disabled, the button is greyed out.
Standard buttons For standard buttons (e.g. arrow buttons, lock, Print) see
chapter 6.3.
6. Software Functions
LIAISON
®
XS - Instruction for use Rev. H Page 6-39
A calibration cannot be started if any of the following occurs:
• another calibration is in status “Created” or “Ongoing” for the same integral
• another calibration is in status “Created” or “Ongoing” for another integral of the same
lot (if that assay shares the Working Curve)
• the calibrators are external and not present on board
• any required resource is detected as missing or empty; see chapter 6.12.3 to check
whether the available resources are sufficient.
Function Description
1...10 Shows the integrals in the reagent loading bay lanes. Tap on a
loaded integral to show details.
Abbreviation Abbreviation of the assay.
LIS alias Assay name on the LIS system.
Article No. Identification code of the selected integral that allows the
LIAISON
®
XS system to associate the integral to an assay.
Kit No. Kit No number of the reagent integral.
Kit Lot Lot number of the reagent integral.
Integral Layout
Parameter that allows the LIAISON
®
XS system to identify the
geometric characteristics of the integral
Master Curve ID The ID of the calibration mastercurve used for this reagent
integral.
Shelf Expiry date Date and time when the reagent integral will expire. Note: this is
the last day when that reagent integral is allowed to be used.
On-board Expiry date The calculated result obtained with that kit after that day has
elapsed will be provided with an indicating flag. Check the
on-board stability in the instruction for use of each kit.
Integral Status Status of the integral availability:
• Online: The integral is usable
• Offline: The integral cannot be used. The abbreviation is
displayed in grey.
Possible reasons:
○ No liquid found.
○ The expiration date is exceeded.
○ The compatible assay protocol version is not loaded.
○ The integral has been disabled by user
○ The integral reagent has a data recognition issue.
Calibration Status Status of the calibration (e.g. valid, not valid).
Original No. of Tests Max. number of tests with a new integral.
Remaining Tests Remaining number of determinations for the selected integral.
The number is updated (decremented by one) as soon as the
first aspiration event for a determination occurs.
Booked Tests Assigned but not started tests.
6. Software Functions
Page 6-40 LIAISON
®
XS - Instruction for use Rev. H
Table 6–32: Functions of the Details group
In case of loading errors, the integral lane is displayed with a red exclamation mark:
Figure 6–28: Integral lane in error
6.6 Main Category Results
The results of the sample tests or calibrations can be accessed via the main category
Results as well as its several sub categories.
The following table lists all possible columns that can be found in the table of each result
page; default columns displayed in each page are reported in the specific chapters.
Available Tests Difference between Remaining Tests and Booked Tests.
Remaining
Calibrations
Remaining number of calibrations.
Possible Column Description
Sample ID Shows the sample ID.
Assay Shows the assigned assay.
Measured
Result date and time (expected for those results that are not yet
completed).
Status Shows the status of the entry (see table 6–35).
Function Description
6. Software Functions
LIAISON
®
XS - Instruction for use Rev. H Page 6-41
Table 6–33: Possible Columns in Results pages
Dilution Dilution factor for the result.
RLU Shows the raw results (in Relative Light Units).
Flags List of all flags. For details about the flags, see chapter 5.8.5
Dose Shows the dose result in user units.
User Unit Shows the user unit.
Conversion Shows the conversion factor used to calculate dose.
Label Shows the qualitative label for the result (if defined for the
assay).
Sent to LIS Date and time when the result was sent to LIS.
Control Name Name of the control.
Control Lot The lot number of the control.
Manufacturer Range The low and high limit of this control definition in user unit.
User Range The low and high limit of the reference range for this control,
in user unit.
Control Expiry Shelf expiry date of the control.
Sample Lane
Lane in the loading bay where the sample rack was located.
Sample Position
Tube position in sample rack where the sample was aspirated
from.
Rack Type The rack type of the rack where the sample was aspirated from.
Rack ID The rack ID of the rack where the sample was aspirated from.
Dose CV% Shows the coefficient of variation (%) for the dose result.
RLU CV% Shows the coefficient of variation (%) of the RLU result.
Kit No. Kit number of the used reagent integral.
Kit Lot Kit lot number of the used reagent integral.
Kit Shelf Expiry Shelf expiry date of the used reagent integral.
Kit On-Board Expiry On-board stability expiry date of the used reagent integral.
Starter 1 Lot Lot number of the used starter 1.
Starter 2 Lot Lot number of the used starter 2.
Ancillary Lot Lot number of the used ancillary reagent.
Ancillary No. Serial number of the used ancillary reagent.
Ancillary Shelf Expiry Expiry date of the ancillary.
Ancillary On-Board
Expiry
On-board stability expiry date for the ancillary reagent.
Calibration ID Internal unique ID assigned to this calibration record. This ID
will be not reused even after the calibration has been deleted.
Calibration Expiry Date when the calibration will expire.
Assay Range Shows the low and high limit of the assay range for the assay,
in user defined unit.
Normal Range Shows the low and high limit of the normal range for the assay,
in user defined unit.
Possible Column Description
6. Software Functions
Page 6-42 LIAISON
®
XS - Instruction for use Rev. H
Sorting and Searching
See chapter 6.3.2.
6.6.1 Sub Category All
The sub category All shows all entries of applied, started, and finished worklists. This sub
category does not include calibrations and archived results.
Subcategories Worklist, Ongoing, Done, Failed, Controls are subset of the All page.
The default available columns are: Sample ID, Assay, Measured, Status, Dilution, RLU,
Flags.
Figure 6–29: Sub category All
Table 6–34: Functions of the All sub category
Function Description
Delete Deletes one or more entries (see chapter 6.6.1.3).
Only entries in status To Do, Placed, Measured, Done and
Failed can be deleted.
For Combi Assays, if a Son is selected, a pop-up ask the user to
delete the entire family or revoke the request.
Export Opens the Export display to export one or more entries to a file
(see chapter 6.6.1.1).
Download Sends a query all message to a LIS system to initiate
transmission of workorders. The LIAISON
®
XS software shows
an information dialog.
Filter Opens the Select Filter display (see chapter 6.6.1.4).
Details Opens the Result Details display for the selected entry
(see chapter 6.6.1.2).
Standard buttons For standard buttons (e.g. arrow buttons, lock, Print) see
chapter 6.3.
6. Software Functions
LIAISON
®
XS - Instruction for use Rev. H Page 6-43
Table 6–35: Result status descriptions
6.6.1.1 Export
The Export display allows the exporting of one or more entries to a file.
Figure 6–30: Export display
Selection Group
Table 6–36: Functions of the Selection group
Results Status Description
To do Sample not present on board, not started yet
Placed Sample present on board, not started yet
Scheduled Starting soon
Active Under performance
Measured Completed but no dose received
Done Successfully completed
Failed Unsuccessfully completed
In case a sample test is performed with two or more replicates and its status is “failed”,
and there are some replicates that still need to be started, they may be restarted when a
new routine is started. In this case, the entire sample test would become “active” again.
Function Description
Selected Records Exports only the selected entries from the list.
All Records Exports all entries currently present on the page list. If a filter is
applied before the export then the export will consider also the
filter.
6. Software Functions
Page 6-44 LIAISON
®
XS - Instruction for use Rev. H
Mode Group
Table 6–37: Functions of the Mode Group
File Selection Group
Table 6–38: Functions of the Export Settings group
6.6.1.2 Result Details
The Result Details display is used to display all available information for a test.
Note: the layout may vary depending on the sample and assay characteristics.
Figure 6–31: Result Details display
Table 6–39: Result Details buttons
Function Description
Default Basic set of information (e.g. sample ID, assay, measured date
and time, dose result and accompanying flags).
Enhanced Same as default with additional appended columns
(e.g. reagents information).
Function Description
Path Selection among the available path the file can be exported to.
File Allow to specify file name.
Files list Visualize the entries stored in the selected path.
Function Description
View Event Shows the event associated with the result
Standard buttons For standard buttons (e.g. arrow buttons, lock, Print) see
chapter 6.3.
6. Software Functions
LIAISON
®
XS - Instruction for use Rev. H Page 6-45
Table 6–40: Functions of the Result Details display
Function Description
Sample ID Shows the sample ID.
Sample lane Lane in the loading bay for sample racks where the sample rack
was located.
Sample position Tube position in sample rack where the sample was aspirated
from.
Rack ID The rack ID of the rack where the sample was aspirated from.
Assay Shows the assigned assay.
Dilution Factor Dilution factor for the result.
Status Shows the status of the entry (To Do, Placed, Scheduled,
Active, Measured, Done, Failed).
Measured Date The date when the result was measured or the expected result
time if the test is Scheduled or Active.
Measured Time The time when the result was measured or the expected result
time if the test is Scheduled or Active.
Conversion Factor Reports the conversion factor used to calculate dose.
Example:
• Default unit: g/l
• User defined unit: mg/l
• Conversion factor: 1000
Assay Range Shows the low and high limit of the assay range for the assay, in
user defined unit. Results are compared against the assay range
before being adjusted with the dilution factor. The assay range
value used to report an out of assay range result is not multiplied
by the dilution factor.
When a result falls outside this range, it will be provided with the
corresponding flag; it will be shown as “<” followed by the low
limit or “>” followed by the high limit.
The low limit is included and the high limit is excluded.
If a limit field is empty the LIAISON
®
XS software will handle this
as “do not care”. This allows to support one-sided ranges.
Normal Range The low and high limit of the normal range for the assay, in user
defined unit. When a result falls outside this range, it will be
provided with the corresponding flag. Results are compared
against the normal range after being adjusted with the dilution
factor.
The low limit is included and the high limit is excluded.
If a limit field is empty, the LIAISON
®
XS software will handle this
as “do not care”. This allows to support one-sided ranges.
6. Software Functions
Page 6-46 LIAISON
®
XS - Instruction for use Rev. H
Results Group
Figure 6–32: Results Group
Table 6–41: Functions of the Results group
Table 6–42: Columns of the Results group tables
Function Description
Result (Average) Shows the dose result calculated from the mean RLU result. It is
reported in user units, adjusted with the dilution factor.
Below the mean result, the qualitative label is shown (only for
patient samples, if defined).
Result CV Shows the coefficient of variation (%) for the dose result.
RLU (Average) Shows the mean RLU result (truncated).
RLU CV Shows the coefficient of variation (%) of the RLU result.
Column Description
Flags List of flags per replicate. For details about the flags see
chapter 5.8.5.
Replicate Results List containing all replicate dose results in user units
(calculated and converted for each single replicate RLU result).
Replicate RLU List containing all replicate RLU results.
Flag Summary List of all flags associated to this specific test, displayed
as complete description. For details about the flags see
chapter 5.8.5.
6. Software Functions
LIAISON
®
XS - Instruction for use Rev. H Page 6-47
Depending on the used assay(s) the LIAISON
®
XS software will show the following result
details/values:
Table 6–43: Shown result details/values
Reagents Group
Figure 6–33: Results Details- Reagents Group
Value Regular assay Combi assay
Result (Average) Dose, Qualitative label Dose and/or Qualitative label
Result CV Yes No
RLU (Average) Yes No
RLU CV Yes No
Flags Yes Yes
Replicate Results Yes No
Replicate RLU Yes No
Flag Summary Yes Yes
6. Software Functions
Page 6-48 LIAISON
®
XS - Instruction for use Rev. H
Table 6–44: Functions of the Reagents group
Function Description
Ancillary On-board
Expiry date
On-board stability expiry date for the ancillary reagent
(if present).
Note: ancillaries expire at midnight of the displayed date.
Ancillary Shelf Expiry
date
Shelf expiration date of the used ancillary reagent (if present).
Note: ancillary expire at midnight of the displayed date.
Ancillary Serial No. Serial number of the used ancillary reagent (if present).
Ancillary Reagents
Lot No.
Lot number of the used ancillary reagent (if present).
Calibration Expiry
date
Expiry date of the calibration used for result calculation.
Note: calibrations expire at midnight of the displayed date.
Calibration ID Unique identifier of the calibration used for result calculation.
Kit Shelf Expiry date Shelf expiry date of the used reagent integral.
Note: kits expire at midnight of the displayed date.
Kit Lot Kit lot number of the used reagent integral.
Kit No. Kit number of the used reagent integral.
Kit On-board Expiry
date
On-board stability expiry date of the used reagent integral.
Note: kits expire on-board at midnight of the displayed date.
Starter 1 Lot Lot number of the used starter 1.
Starter 2 Lot Lot number of the used starter 2.
For Combi Assays, this tab contains all the combi sons information.
6. Software Functions
LIAISON
®
XS - Instruction for use Rev. H Page 6-49
Process Group
Figure 6–34: Results Details- Process tab
Table 6–45: Functions of the Process group
Function Description
Rack ID* The rack ID of the rack where the sample was aspirated from.
Archived by Name of the user, who was logged in when the result was
archived.
Archiving time Date and time when the result was archived.
Calculated by* Name of the user, who was logged in when the result calculation
was done.
Calculation Time* Date and time when the result was calculated.
Started by* Name of the user, who was logged in when the test was started.
Note: if a test is started as a consequence of a Rerun Rule,
this field is left empty.
Start Time* Date and time when the first aspiration occurred for the test.
Note: In case of two or more replicates this time refers to the first
replicate.
Sent by Name of the user, who was logged in when the result was sent to
LIS.
Sent to LIS Date and time when the result was sent to LIS.
STAT [y/n]* Shows “Y” for samples with STAT priority, “N” for normal priority
samples.
Deleted time Date and time when the results was deleted (always empty).
Deleted by Name of the user, who was logged in when the results was
deleted (always empty).
6. Software Functions
Page 6-50 LIAISON
®
XS - Instruction for use Rev. H
Patient Group
Figure 6–35: Results Details- Patient tab
Table 6–46: Functions of the Patient group
For the fields marked with *, in case of Combi Assays, this tab contains the information for
each combi son.
Function Description
Name Patient name.
Gender Gender of the patient (Female, Male, or Unknown).
Date of birth Date of birth of the patient.
Pat. ID Unique ID used to identify the patient on a LIS system.
Sender Name or code of the doctor who will analyze the result.
Location Location of the patient provenience.
6. Software Functions
LIAISON
®
XS - Instruction for use Rev. H Page 6-51
Q-Flag (Patient Sample only)
A table indicating which Control Definition and, if applicable, which rule of the related RVC
caused the Q flag (see chapter 6.8.1.2).
Figure 6–36: Result Details - Q-Flags tab
If the Result has no flag, than the table has no entries, but only headers.
If the Control Definition has no RVC or the RVC has no rule and the last performance of
such control was outside ranges, it generates a row without crosses.
Table 6–47: Functions of the Q-Flags
Column Description
Control Name Name of the control
Kit Containing a cross if this rule caused a flag, otherwise empty
Calibration Containing a cross if this rule caused a flag, otherwise empty
Ancillary Containing a cross if this rule caused a flag, otherwise empty
Time Containing a cross if this rule caused a flag, otherwise empty
6. Software Functions
Page 6-52 LIAISON
®
XS - Instruction for use Rev. H
6.6.1.3 Delete Data
Figure 6–37: Delete Data display
Table 6–48: Functions of the Delete Data display
6.6.1.4 Select Filter
The Filter Button opens the Filter Dialog.
Figure 6–38: Select Filter display
An indication if any filter is active is located in the top right corner, near the number of total
records.
Figure 6–39: Filter applied
Function Description
Selected Records Deletes all selected entries from the list.
All Records Deletes all entries currently present on the page list. If a filter is
applied before the deletion then the deletion will be applied the
entries matching the filter criteria.
6. Software Functions
LIAISON
®
XS - Instruction for use Rev. H Page 6-53
Table 6–49: Functions of the Select Filter display
6.6.2 Sub Category Worklist
The sub category Worklist shows only entries of tests with status To do and Placed.
The default available columns are: Sample ID, Assay, Status, Dilution.
Figure 6–40: Sub category Worklist
Function Description
All Records Selects all entries from the list.
Filtered Selects only the entries according to filters.
Today’s Records Selects all entries from this day from the list.
Today refers always to “Measured Date” for Results, “Due” for
Maintenance and “Started” for Test Statistics.
Range 1 Selects only entries with the specified conditions By, From, To
and Contains from the list.
Range 2 Selects only entries with the specified conditions By, From, To
and Contains from the list.
By Options that can be used for filtering (e.g. Assay, Sample ID)
From/To Define the range for the filter. Both limits are included.
Contains Define which value(s) the filtered items shall contain
6. Software Functions
Page 6-54 LIAISON
®
XS - Instruction for use Rev. H
Table 6–50: Functions of the Worklist sub category
6.6.3 Sub Category Ongoing
The sub category Ongoing shows only entries of started worklists with status Scheduled,
Active, and Measured.
The default available columns are: Sample ID, Assay, Measured, Status, Dilution, Flags.
Figure 6–41: Sub category Ongoing
Function Description
Delete Deletes one or more entries, see chapter 6.6.1.3.
For Combi Assays, if a Son is selected, a pop-up ask the user to
delete the entire family or revoke the request.
Download Sends a “query all” message to a LIS system to initiate
transmission of workorders. The LIAISON
®
XS software shows
an information dialog.
Filter Opens the Select Filter display (see chapter 6.6.1.4).
Details Opens the Result Details display for the selected entry
(see chapter 6.6.1.2).
Standard buttons For standard buttons (e.g. arrow buttons, lock, Print) see
chapter 6.3.
6. Software Functions
LIAISON
®
XS - Instruction for use Rev. H Page 6-55
Table 6–51: Functions of the Ongoing sub category
6.6.3.1 Recalculate
Recalculates the currently selected entries, using the most recent calibration for the
assigned assay. For Combi Assays, all results for the same assay family are recalculated.
Figure 6–42: Recalculate
Table 6–52: Recalculate
Function Description
Recalculate Recalculates the currently selected entries, using the most
recent calibration for the assigned assay. For Combi Assays,
all results for the same assay family are recalculated.
Abort Turns the test into Failed and aborts the related processing.
Filter Opens the Select Filter display (see chapter 6.6.1.4).
Details Opens the Result Details display for the selected entry
(see chapter 6.6.1.2).
Standard buttons For standard buttons (e.g. arrow buttons, lock, Print) see
chapter 6.3
Do not use for Active tests.
Function Description
Selected Records Recalculates all selected entries from the list.
All Records Recalculates all entries currently present on the page list. If a
filter is applied before the recalculation then the recalculation will
be applied the entries matching the filter criteria.
6. Software Functions
Page 6-56 LIAISON
®
XS - Instruction for use Rev. H
6.6.4 Sub Category Done
The sub category Done shows only entries of finished worklists with status Done.
The default available columns are: Sample ID, Assay, Measured, Dilution Dose, User
Unit, Label, Flags.
Figure 6–43: Sub category Done
6. Software Functions
LIAISON
®
XS - Instruction for use Rev. H Page 6-57
Table 6–53: Functions of the Done sub category
Function Description
Recalculate Recalculates the currently selected entries, using the most
recent calibration for the assigned assay. For Combi Assays, all
results for the same assay family are recalculated.
Delete
Deletes one or more entries, see chapter 6.6.1.3.
For Combi Assays, if a Son is selected, a pop-up ask the user to
delete the entire family or revoke the request.
Export Opens the Export display to export one or more entries to a file
(see chapter 6.6.1.1).
Archive Allows to archive the currently selected entries, opening a
selection display (see chapter 6.6.4.1). The archived entries will
be shown in the sub category Archived.
For Combi Assays, if a Son is selected, a pop-up ask the user to
archive the entire family or revoke the request.
Note: This button is available only if automatic archiving is not
enabled.
Rerun Allows to repeat the test of one or more entries, opening a
selection display (see chapter 6.6.4.2).
For Combi Assays, if a Combi Father is selected, all results of the
same assay family are recalculated; otherwise, only the selected
Combi Son is rerun.
Note: the entries will be set either to Placed (if the sample is
present on board) or to To Do (if the sample is not present on
board).
Filter Opens the Select Filter display (see chapter 6.6.1.4).
Details Opens the Result Details display for the selected entry
(see chapter 6.6.1.2).
Standard buttons For standard buttons (e.g. arrow buttons, lock, Print) see
chapter 6.3
Dose calculation will be done automatically by the system as soon as a valid calibration is
available, provided that all the following conditions are met:
• the samples are successfully analyzed but without a dose (i.e. in status Measured),
• the samples were tested with the same kit (if the curve is not shared) or with a kit from
the same lot (if the curve is shared),
• the sample RLU results were obtained no more than 18 hours before the calibration.
6. Software Functions
Page 6-58 LIAISON
®
XS - Instruction for use Rev. H
6.6.4.1 Archive
Archives the currently selected entries. The archived entries will be shown in the sub
category Archived.
Figure 6–44: Archive
Table 6–54: Functions of Archive
6.6.4.2 Rerun
Reschedules one or more entries.
Figure 6–45: Rerun
This button is available only if automatic archiving is not enabled.
Function Description
Selected Records Moves all selected entries in the Archived tab.
All Records Moves all entries currently present on the Archived tab page list.
If a filter is applied before the archiving then the archiving will be
applied the entries matching the filter criteria.
6. Software Functions
LIAISON
®
XS - Instruction for use Rev. H Page 6-59
Table 6–55: Functions of Rerun
6.6.5 Sub Category Archived
The sub category Archived shows only archived tests. The shown entries are not present
in the sub category All.
The default available columns are: Sample ID, Assay, Measured, Dilution, Dose, User
Unit, Label, Flags, Sent To LIS.
Figure 6–46: Sub category Archived
Function Description
Selected Records Reruns all selected entries from the list.
All Records Reruns all entries currently present on the page list. If a filter is
applied before the rerun then the rerun will be applied the entries
matching the filter criteria.
Dilution factor Set the dilution factor to be applied (only if one result is selected).
Replicates Set the number of replicates to be processed (only if one result is
selected).
Priority Set the sample priority (only if one result is selected).
The entries will be set either to Placed (if the sample is present on board) or to To Do
(if the sample is not present on board).
6. Software Functions
Page 6-60 LIAISON
®
XS - Instruction for use Rev. H
Table 6–56: Functions of the Archived sub category
6.6.6 Sub Category Failed
The sub category Failed shows only entries of finished tests with status Failed.
The default available columns are: Sample ID, Assay, Measured, Dilution, Flags.
Figure 6–47: Sub category Failed
Function Description
Delete Deletes one or more entries,see chapter 6.6.1.3.
For Combi Assays, if a Son is selected, a pop-up ask the user to
delete the entire family or revoke the request.
Export Opens the Export display to export one or more entries to a file
(see chapter 6.6.1.1).
Upload Transmits the selected entries to the LIS system.
The LIAISON
®
XS software shows an information dialog.
Filter Opens the Select Filter display (see chapter 6.6.1.4).
Details Opens the Result Details display for the selected entry
(see chapter 6.6.1.2).
Standard buttons For standard buttons (e.g. arrow buttons, lock, Print) see
chapter 6.3.
The system can be configured to perform a periodical automatic backup and clean up of
archived results. Those results can be retrieved using the functionality described in the
History page (see chapter 6.6.9).
6. Software Functions
LIAISON
®
XS - Instruction for use Rev. H Page 6-61
Table 6–57: Functions of the Failed sub category
Function Description
Recalculate Recalculates the currently selected entries, using the most
recent calibration for the assigned assay (see chapter 6.6.3.1).
For Combi Assays, all results for the same assay family are
recalculated.
Delete Deletes one or more entries (see chapter 6.6.1.3).
For Combi Assays, if a Son is selected, a pop-up ask the user to
delete the entire family or revoke the request.
Archive Archives the currently selected entries (see chapter 6.6.4.1).
The archived entries will be shown in the sub category Archived.
For Combi Assays, if a Son is selected, a pop-up ask the user to
archive the entire family or revoke the request.
Note: This button is available only if automatic archiving is not
enabled.
Rerun Allows to repeat the test of one or more entries, opening a
selection display (see chapter 6.6.4.2).
For Combi Assays, if a Combi Father is selected, all results of the
same assay family are recalculated; otherwise, only the selected
Combi Son is rerun.
Note: the entries will be set either to Placed (if the sample is
present on board) or to To Do (if the sample is not present on
board).
Filter Opens the Select Filter display (see chapter 6.6.1.4).
Details Opens the Result Details display for the selected entry
(see chapter 6.6.1.2).
Standard buttons For standard buttons (e.g. arrow buttons, lock, Print) see
chapter 6.3.
6. Software Functions
Page 6-62 LIAISON
®
XS - Instruction for use Rev. H
6.6.7 Sub Category Calibrations
The sub category Calibrations shows only calibration entries (in any possible status).
The default available columns are: Calibration ID, Assay, Kit Lot, Kit No., Measured,
Calibration Expiry, Status, Started by.
Figure 6–48: Sub category Calibrations
Table 6–58: Functions of the Calibrations sub category
Function Description
Disable Disables one or more selected calibration entries, i.e. changes
the status of all “Valid” or “Created” calibrations among the
selected ones to “Disabled”.
Note: all related integrals will need to be recalibrated to produce
new dose results.
Export Opens the Export display to export one or more entries to a file
(see chapter 6.6.1.1).
View Reagents Opens the sub category Integrals (see chapter 6.5.3).
Filter Opens the Select Filter display (see chapter 6.6.1.4).
Details Opens the Calibration Details display for the selected entry
(see chapter 6.6.7.1).
Standard buttons For standard buttons (e.g. arrow buttons, lock, Print)
see chapter 6.3.
6. Software Functions
LIAISON
®
XS - Instruction for use Rev. H Page 6-63
Table 6–59: Calibration status descriptions
6.6.7.1 Calibration Details
Figure 6–49: Calibration details display
Status Description
Created The Calibration is just created, not yet measured.
Ongoing The Calibration is scheduled.
Valid The Calibration was successfully measured and calculated.
Expired The Calibration was valid but the expiration period is over.
Invalid The calibrators were processed, but the calibration result has
been rejected by the software.
Not Used A newer calibration is validated.
Not Used Lot The calibration is automatically disabled because of a starter lot
change.
Failed One of the calibrators is failed.
Note: a failed calibrator replicate out of three could be treated as
outlier, and the calibration could result as valid.
Disabled The calibration is manually disabled.
All calibration values are not editable.
6. Software Functions
Page 6-64 LIAISON
®
XS - Instruction for use Rev. H
Table 6–60: Functions
Table 6–61: Functions of the Results group
Function Description
Assay Assay abbreviation.
Kit Lot Lot number of the used reagent integral.
Calibration ID Internal unique ID assigned to this calibration record. This ID will
be not reused even after the calibration has been deleted.
Expiry date Date when the calibration will expire.
Note: calibrations expire at midnight of the displayed date.
Status Shows the status of the entry (Created, Ongoing, Failed,
Invalid, Valid, Expired, Not Used, Not Used Lot, Disabled).
Standard buttons For standard buttons (e.g. arrow buttons, lock, Print) see
chapter 6.3.
Function Description
Calibrator RLU Displays the RLU values of each calibrator replicates.
Mean (RLU) Displays the mean RLU value for calibrator 1 and 2.
CV% (RLU) Displays the percent variation coefficient for RLU results of
calibrator 1 and 2. If the CV% exceeds the max RLU CV%, the
exceeded value is shown in red. In this case, the calibration will
be invalid.
Max CV% (RLU) Displays the assay max RLU CV% for calibrator 1 and 2.
Deviation% (RLU) Displays the percent deviation from the nominal RLU value for
calibrator 1 and 2. If the mean RLU is out of the tolerance range,
the exceeded value is shown in red. In this case, the calibration
will be invalid.
Tolerances% (RLU) The tolerance range for RLU values of calibrator 1 and 2.
Target (RLU) Shows the nominal values of the RLU results of calibrator 1 and 2
(if applicable).
Ratio (Geometric
Curve Check)
The ratio between the RLU values of two given points of the
working curve, when a range is defined.
The range limits are shown in red if the ratio exceeds the
tolerance range. In this case, the calibration will be invalid.
Range (Geometric
Curve Check)
The allowed range for the Ratio field of the Geometric Curve
Check, when defined.
Expected (Dose) Displays the nominal values of the dose of calibrator 1 and 2.
Backfit (Dose) Displays the obtained dose for calibrator 1 and 2 (if applicable).
Cut-off (Dose) Displays the factor used for calculate the calibrator dose
(if applicable).
6. Software Functions
LIAISON
®
XS - Instruction for use Rev. H Page 6-65
Graphics Group
The Graphics group shows the plot of the actual working curve (black) and the acceptance
limits derived from the master curve (green). The concentration values are reported in user
units. The graphic is available only for quantitative calibrations.
The software automatically adjusts the X and Y axis, in order to fit the obtained working
curve.
Figure 6–50: Calibration Details- Graphics
Table 6–62: Functions of the Graphics group
Function Description
Graphic Displays the obtained working curve and the acceptance range.
X-Axis
• Concentration (unit: in user unit depends on assay settings;
scale: logarithmic)
Y-Axis
• RLU (scale: linear)
Master Curve ID The ID of the master curve used for this calibration.
User Unit User unit defined
6. Software Functions
Page 6-66 LIAISON
®
XS - Instruction for use Rev. H
Traceability Group
Figure 6–51: Calibration Details- Traceability
Table 6–63: Functions of the Traceability group
Function Description
Measured time The date and time when the calibrator RLUs were measured.
Started by Name of the user, who was logged in when the calibration was
started.
Start time The date and time when the calibration was started.
Flag list List of relevant result flags obtained for this calibration.
For details about the flags see chapter 5.8.5.
Kit Lot Lot number of the used reagent integral.
Kit No. Kit number of the used reagent integral.
Shelf Expiry date
(Kit)
Shelf expiry date of the used reagent integral.
On-board Expiry date
(Kit)
On-board stability expiry date of the used reagent integral.
Ancillary Lot Lot number of the used ancillary reagent.
Only visible if there are ancilliaries in the reagent setup.
Serial No. Serial number of the used ancillary reagent.
Only visible if there are ancilliaries in the reagent setup.
Shelf Expiry date
(Ancillary)
Shelf expiry date of the used ancillary.
On-board Expiry date
(Ancillary)
On-board stability expiry date of the used ancillary.
Starter lot No. Lot number of the used starter 1 and 2.
6. Software Functions
LIAISON
®
XS - Instruction for use Rev. H Page 6-67
6.6.8 Sub Category Controls
The sub category Controls shows the results of the controls.
The default available columns are: Sample ID, Assay, Dose, User Unit, Flags, Measured,
Control Lot, Control Expiry, Manufacturer Range, User Range, Control Name.
Figure 6–52: Sub category Controls
Table 6–64: Functions of the Controls sub category
Function Description
Delete Deletes one or more entries (see chapter 6.6.1.3).
Export Opens the Export display to export one or more entries to a file
(see chapter 6.6.1.1).
Filter Opens the Select Filter display (see chapter 6.6.1.4).
Details Opens the Result Details display for the selected entry
(see chapter 6.6.8.1).
Standard buttons For standard buttons (e.g. arrow buttons, lock, Print) see
chapter 6.3.
6. Software Functions
Page 6-68 LIAISON
®
XS - Instruction for use Rev. H
6.6.8.1 Control Details
The Result Details display is used to display all available information for a control.
Figure 6–53: Results Control Details display
Function Description
Sample ID Shows the sample ID of the control
Control Name Name of the control
Control Lot The lot of the control
Control Expiry Shelf expiry date of the control
Sample Lane
Lane in the loading bay for where the sample rack was located.
Sample Position Tube position in sample rack where the control was aspirated
from.
Assay Shows the assigned assay.
Status Shows the status of the entry (To do, Placed, Scheduled,
Active, Measured, Done, Failed).
Measured date The date when the result was measured or the expected result
time if the test is Scheduled or Active.
Measured time The time when the result was measured or the expected result
time if the test is Scheduled or Active.
Conversion Factor Reports the conversion factor used to calculate dose.
Example:
• Default unit: g/l
• User defined unit: mg/l
• Conversion factor: 1000
Assay Range The low and high limit of the assay range for the assay, in user
defined unit.
When a control falls outside this range, it will be provided with the
corresponding flag; it will be shown as “<” followed by the low
limit or “>” followed by the high limit.
6. Software Functions
LIAISON
®
XS - Instruction for use Rev. H Page 6-69
Table 6–65: Functions of the Result Details display
Results Group
Table 6–66: Functions of the Result group
Table 6–67: Columns of the Results group tables
Depending on the used assay(s) the LIAISON
®
XS software will show the following result
details/values:
Table 6–68: Shown result details/values
Manufacturer Range The low and high limit of the manufacturer range for the control,
in user defined unit. When a control falls outside this range, it will
be provided with the corresponding flag.
User Range The low and high limit of the user range for the control, in user
defined unit. When a control falls outside this range, it will be
provided with the corresponding flag.
Standard buttons For standard buttons (e.g. arrow buttons, lock, Print) see
chapter 6.3.
Function Description
Result (Average) Shows the dose result calculated from the mean RLU result. It is
reported in user units, adjusted with the dilution factor.
Result CV Shows the coefficient of variation (%) for the dose result.
RLU (Average) Shows the mean RLU result (truncated).
RLU CV Shows the coefficient of variation (%) of the RLU result.
Column Description
Flags List of flags per replicate. For details about the flags see
chapter 5.8.5.
Replicate Result List containing all replicate dose results in user units
(calculated and converted for each single replicate RLU result).
Replicate RLU List containing all replicate RLU results.
Flag Summary List of all flags associated to this specific control, displayed as
complete description. For details about the flags see chapter 5.8.5.
Value Regular assay Combi assay
Result (Average) Dose Dose
Result CV Yes No
RLU (Average) Yes No
RLU CV Yes No
Flag Summary Yes Yes
Replicate Results Yes No
Replicate RLU Yes No
Flags Yes Yes
Function Description
6. Software Functions
Page 6-70 LIAISON
®
XS - Instruction for use Rev. H
Reagents Group
Table 6–69: Functions of the Reagents group
Function Description
Ancillary On-board
Expiry date
On-board stability expiry date for the ancillary reagent
(if present).
Note: ancillaries expire at midnight of the displayed date.
Ancillary Shelf Expiry
date
Shelf expiry date of the used ancillary reagent (if present).
Note: ancillary expire at midnight of the displayed date.
Ancillary Serial No. Serial number of the used ancillary reagent (if present).
Ancillary Reagents
Lot No.
Lot number of the used ancillary reagent (if present).
Calibration Expiry
date
Expiry date of the calibration used for result calculation.
Note: calibrations expire at midnight of the displayed date.
Calibration ID Unique identifier of the calibration used for result calculation.
Kit Shelf Expiry date Shelf expiry date of the used reagent integral.
Note: kits expire at midnight of the displayed date.
Kit Lot Kit lot number of the used reagent integral.
Kit No. Kit number of the used reagent integral.
Kit Onboard Expiry
date
On-board stability expiry date of the used reagent integral.
Note: kits expire on-board at midnight of the displayed date.
Starter 1 Lot Lot number of the used starter 1.
Starter 2 Lot Lot number of the used starter 2.
For Combi Assays, this tab contains all the combi sons information.
6. Software Functions
LIAISON
®
XS - Instruction for use Rev. H Page 6-71
Process Group
Table 6–70: Functions of the Process group
Function Description
Rack ID The rack ID of the rack where the sample was aspirated from.
Archived by Name of the user, who was logged in when the result was
archived.
Archiving time Date and time when the result was archived.
Calculated by* Name of the user, who was logged in when the result calculation
was done.
Calculation Time* Date and time when the result was calculated.
Started by* Name of the user, who was logged in when the test was started.
Start Time* Date and time when the first aspiration occurred for the test.
Note: In case of two or more replicates this time refers to the first
replicate.
Sent by Name of the user, who was logged in when the result was sent to
LIS.
Sent to LIS Date and time when the result was sent to LIS.
STAT [y/n]* Shows “Y” for samples with STAT priority, “N” for normal priority
samples.
Deleted time Date and time when the results was deleted (always empty).
Deleted by Name of the user, who was logged in when the results was
deleted (always empty).
6. Software Functions
Page 6-72 LIAISON
®
XS - Instruction for use Rev. H
6.6.9 Sub Category History
The subcategory History shows, by default, all entries that have been moved, by means of
the auto backup process, from the Archive subcategory (historicized results).
For details about the auto backup, see chapter 6.9.5.
The function Query allows to specify a patient driven query to populate the History page
with all the results matching such query gathered from All, Archive and History.
The default available columns are: Sample ID, Assay, Measured, Status, Dilution, RLU,
Dose, User Unit, Label, Flags.
Figure 6–54: Sub Category History
Table 6–71: Functions of the History
Function Description
Query Opens the Select Query display (see chapter 6.6.9.1).
Export Opens the Export display to export one or more entries to a file
(see chapter 6.6.1.1).
Filter Opens the Select Filter display (see chapter 6.6.1.4).
Standard Buttons For standard buttons (e.g. arrow buttons, lock, Print) see
chapter 6.3.
6. Software Functions
LIAISON
®
XS - Instruction for use Rev. H Page 6-73
6.6.9.1 Query
An indication if any query is applied is located in the top right corner, near the number of
total records.
Figure 6–55: Query applied
Figure 6–56: Select Query
Table 6–72: Select Query
6.7 Main Category Events
In the main category Events, all messages and errors occurred are listed according to their
type.
When the main category Events is opened, then that sub category will be opened too,
which has new content in it, i.e.:
1. the sub category Messages will be opened as long as there are
unacknowledged messages,
2. the sub category Event Log will be opened.
In case of any fatal error or message that requires immediate user attention, a pop up is
automatically displayed.
Sorting and Searching
See chapter 6.3.2.
Function Description
Historicized results Shows all results that have been historicized (default).
Query for Patient
(All, Archived,
Historicized)
Searches the results in databases All, Archive and History
based on the defined query.
By Options that can be used to apply the query:Sample ID, Patient
ID and Patient Name.
Query Applies the defined query.
6. Software Functions
Page 6-74 LIAISON
®
XS - Instruction for use Rev. H
6.7.1 Sub Category Event Log
The sub category Event Log lists in real time, any event that occurs on the system.
This includes errors, log in data, result failures and other information that may help
troubleshooting activities.
Figure 6–57: Sub category Event Log
Table 6–73: Functions of the Event Log sub category
Table 6–74: Columns of the event log table
When the Event Log sub category is opened, the event log table is sorted chronologically
in descending order.
Function Description
Filter Opens the Select Filter display (see chapter 6.6.1.4).
Details Shows details about the selected entry (see chapter 6.7.1.1).
Standard buttons For standard buttons (e.g. arrow buttons, lock, Print) see
chapter 6.3.
Column Description
Message Text Shows the event message.
Date Time Shows the date and time when the event occurred.
Code Shows the code of the message.
Severity Shows the severity level of the event (Message, Warning,
Problem, Critical, Fatal, Catastrophic)
Origin Shows the name of the module which originated the event.
Events are described in chapter 8.
6. Software Functions
LIAISON
®
XS - Instruction for use Rev. H Page 6-75
6.7.1.1 Details Event Log
Figure 6–58: Details Event Log
Table 6–75: Details Event Log
Function Description
Message Text Event description
Date Time Event logging time stamp
Code Event identifier
Severity Severity
Origin A string containing the issuer of the event (module and/ or
submodule) as reported in the code.
User The user account name when the event was logged.
Comment The verbose event description that better details the event.
Corrective Actions The suggested action.
6. Software Functions
Page 6-76 LIAISON
®
XS - Instruction for use Rev. H
6.7.2 Sub Category Messages
The sub category Messages shows all messages that have not yet been acknowledged.
Messages are special events containing information that shall be acknowledged by the
user.
Every result invalidating flag will be shown as an error message.
Figure 6–59: Sub category Messages
Table 6–76: Functions of the Messages sub category
Function Description
Control Displays the sub category Controls. The button is only enabled if
there are a “control out of range” events in the message list or
upon login if such messages are still present. The button is
disabled after it is pressed.
Mute Alarm Switches off the instrument beeper.
Acknowledge To accept a selected message tap on the Acknowledge button.
The message will be removed from the list, but it is still available
in the sub category Event Log.
Filter Opens the Select Filter display (see chapter 6.6.1.4).
Details Opens the Details Event display for the selected message
(see chapter 6.7.1.1).
Standard buttons For standard buttons (e.g. arrow buttons, lock, Print) see
chapter 6.3.
6. Software Functions
LIAISON
®
XS - Instruction for use Rev. H Page 6-77
Table 6–77: Columns of the messages table
When the Messages sub category is opened, the messages table is sorted chronologically
in descending order.
6.7.3 Fatal Errors
Fatal errors are a particular category of events that are given when an error occurs for which
the system is not able to recover and has to stop any activity.
Column Description
Message Text Shows the event message.
Date Time Shows the date and time when the event occurred.
Code Shows the code of the message.
Severity Shows the severity level of the event (Message, Warning,
Problem, Critical, Fatal, Catastrophic).
Origin Shows the name of the module which originated the event.
Error messages are described in chapter 8.
Some events trigger the audible alarm to beep. The emitted noise depends on the severity
of the error. Some events trigger also the status light.
For errors that trigger the alarms repeatedly on, use the button Mute Alarm to turn them
off. Acknowledging a message does not turn the alarms off.
6. Software Functions
Page 6-78 LIAISON
®
XS - Instruction for use Rev. H
6.8 Main Category Definitions
In the main category Definitions, the sub categories are information on assays, controls,
assay groups, rerun rules, profiles and sender which can be accessed. Additionally, there
are several editing possibilities available.
6.8.1 Sub Category Assay
In the subcategory Assay, all assays available in the LIAISON
®
XS system at that moment
are indicated. In the table, the assay names and the article numbers and the assignment to
an assay group are indicated. There is the possibility to access further information on the
individual assays.
Figure 6–60: Sub category Assay
Table 6–78: Functions of the Assay sub category
Function Description
Import Imports one or more assays from a file. This function is only
available if the instrument is not running (see chapter 6.8.1.1).
Details Shows details about a selected assay (see chapter 6.8.1.2).
Standard buttons For standard buttons (e.g. arrow buttons, lock, Print) see
chapter 6.3.
If an already existing assay is imported into the LIAISON
®
XS system, only
those parameters of that assay which are not user editable will be overwritten.
Parameters, which are user editable, will be maintained, unless differently explained
by the system.
6. Software Functions
LIAISON
®
XS - Instruction for use Rev. H Page 6-79
Table 6–79: Columns of the assays table
6.8.1.1 Import
Allows multiple file selection. Disabled in Running.
Figure 6–61: Import
Table 6–80: Import
Column Description
Assay Assay name.
LIS Alias Assay name on the LIS system.
Revision Revision number of the assay.
Article No. Article number of the assay.
Group List of groups the assay belongs to.
Column Description
Path Allows to select a directory.
Article No. Article Number of the assay.
Lot No. Lot number of the assay.
6. Software Functions
Page 6-80 LIAISON
®
XS - Instruction for use Rev. H
6.8.1.2 Assay Details
Figure 6–62: Details display
Function Description
Name Assay name.
LIS Alias Assay name on the LIS system.
Abbreviation Abbreviation property of the assay.
Article No. Article number of the assay.
Creation date Creation date of the assay.
Revision Revision number of the assay. Only integrals compatible with this
revision can be used.
On-Board Stability On-board stability of integral.
Sample Replicates Number of replicates for patient samples, up to 20.
It is only allowed to increase the number of replicates, and after
to decrease but no lower than the default number (provided in the
assay file).
Control Replicates Number of replicates for control samples, up to 20.
It is only allowed to increase the number of replicates, and after
to decrease but no lower than the default number (provided in the
assay file).
Priority Scheduling priority (1 to 200) of the assay. Assays with the
highest priority number (starting from 200) will be scheduled
before assays with lower priority number (up to 1) for samples
within a rack (in case of Random Access mode) or within the
entire sample area (in case of Batch mode).
Groups List of all groups which the assay belongs to.
Standard buttons For standard buttons (e.g. arrow buttons, lock, Print) see
chapter 6.3.
6. Software Functions
LIAISON
®
XS - Instruction for use Rev. H Page 6-81
Calculation Group
Figure 6–63: Details- Calculation Group
Table 6–81: Functions of the Calculation group
Changing an assay priority would trigger changes in the order of assay execution, with the
possible consequence of throughput changes.
Function Description
Default Unit Default unit.
User Unit User defined unit (e.g. mg/l). See Conversion Factor below.
Conversion Factor Conversion factor between default unit and user defined unit.
Example:
• Default unit: g/l
• User defined unit: mg/l
• Conversion factor to be specified: 1000
Digits Shows the number of significant digits to be reported for the
result and related ranges/thresholds.
Send replicates to
host
Selection for the result transmission of the replicates to the host
(Yes, No).
Send to Host Selection for the result transmission to the host (Dose, Label,
Both). Applicable only if the assay is provided with labels.
6. Software Functions
Page 6-82 LIAISON
®
XS - Instruction for use Rev. H
Calibration Group
Figure 6–64: Details- Calibration Group
Table 6–82: Functions of the Calibration group
Changes of the user unit and the conversion factor affect only new results.
All dose-related ranges are shown according to the user units, as the software
automatically converts them.
It is necessary to completely save the changed user unit and the conversion factor and
close the Assay detail page, before changing the Normal Range. Changing the Normal
Range before closing the Assay detail page may result in a successive update of the
Normal Range performed automatically by the system, based on the new user unit and
the conversion factor.
Function Description
Calibrator Replicates Shows the number of replicates to be run for calibration.
Calibration Interval Shows the validity period for calibrations.
Calibration shared
within kit lot
Yes:
• The calibration is valid for kit lot (“Shared Working Curve”
approach).
No:
• The calibration is valid for the specific integral (“Not Shared
Working Curve” approach).
If the default setting is No, it is not allowed to select Yes.
6. Software Functions
LIAISON
®
XS - Instruction for use Rev. H Page 6-83
Ranges Group
Figure 6–65: Details - Ranges Group
Table 6–83: Functions of the Ranges group
Function Description
User Unit User defined unit.
Normal Range The low and high limit of the normal range for the assay, in user
defined unit. When a result falls outside this range, it will be
provided with the corresponding flag. Results are compared
against the normal range after being adjusted with the dilution
factor.
The low limit is included and the high limit is excluded.
If a limit field is empty, the LIAISON
®
XS software will handle this
as “do not care”. This allows to support one-sided ranges.
Assay Range Shows the low and high limit of the assay range for the assay, in
user defined unit. Results are compared against the assay range
before being adjusted with the dilution factor. The assay range
value used to report an out of assay range result is not multiplied by
the dilution factor.
When a result falls outside this range, it will be provided with the
corresponding flag; it will be shown as “<” followed by the low limit
or “>” followed by the high limit.
The low limit is included and the high limit is excluded.
If a limit field is empty the LIAISON
®
XS software will handle this as
“do not care”. This allows to support one-sided ranges.
Overdilution Point Shows the overdilution point for that assay, in user defined unit.
If results get lower than the overdilution point it will be considered
not valid and therefore the results will be failed (i.e. dose not given).
Font/Color Opens the Select Font /Select Color display to pick up a font to be
assigned to the currently selected qualitative label.
6. Software Functions
Page 6-84 LIAISON
®
XS - Instruction for use Rev. H
Table 6–84: Columns of the ranges table
Dilutions Group
Shows all (1...max. 10) sample dilution factors, which are defined for the assay.
Figure 6–66: Details- Dilutions Group
In each field (Dilution 2...Dilution 10) a dilution factor in the range from 1 to 6250000 can be
defined. To delete a dilution factor, it is necessary to press the delete button next to the field.
Column Description
Range, Low Limit and
Range, High Limit
The low and high limit for that corresponding qualitative range,
in user defined units, for up to 5 qualitative settings.
The low limit is included and the high limit is excluded.
If a limit field is empty the LIAISON
®
XS software will handle this
as “do not care”. This allows to support one-sided ranges.
Example:
Low: empty; high: 1; Label: neg
Low: 1; high: 10; Label: eq
Low: 10; high: empty; Label: POS
Label The qualitative label to be applied to results within this range.
The label is displayed using the dedicated font and color defined
for that label.
6. Software Functions
LIAISON
®
XS - Instruction for use Rev. H Page 6-85
RVC Group
RVC (Run Validation Criteria) are rules that can be defined either by the manufacturer or
by the user; if an RVC is violated, this will result in a Q flag for the patient sample
(see chapter 6.6.1.2).
Figure 6–67: Details- RVC Group
Table 6–85: Functions of the RVC group
Function Description
Add Add Run Validation Criteria (RVC).
Delete Delete the selected Run Validation Criteria (RVC).
Standard buttons For standard buttons (e.g. arrow buttons, lock, Print) see
chapter 6.3.
To add RVC, the control needs to be defined (see chapter 6.8.2).
If an RVC is defined by the manufacturer:
• the RVC cannot be deleted
• already enabled criteria cannot be modified
• disabled criteria can be enabled/disabled
6. Software Functions
Page 6-86 LIAISON
®
XS - Instruction for use Rev. H
Table 6–86: Columns of the RVC group table
Audit Trails Group
Shows the history of changes of the:
• LIS Alias
• Sample/Control replicates
• Priority
• User unit/Conversion factor
• Send replicate to host
• Send to host
• Calibration shared within kit lot
• Normal range
• Label font/color
• Dilution factors
• RVC
Column Description
Control Name The name of the Control Definitions for which a control to be
executed and in range is required. If no control is present in the
list no RVC are applied to the assay
Kit Requires the control to be in range and executed on the same kit
as the patient sample.
Calibration Requires the control to be in range and calculated with the same
calibration as the patient sample.
Ancillary Requires the control to be in range and executed on the same
ancillary as the patient sample.
Time Use the latest Control that was calculated no more than 18 hours
ago.
6. Software Functions
LIAISON
®
XS - Instruction for use Rev. H Page 6-87
If the user changes one value out of those, then the Audit Trails group is activated and the
user is prompted to type in a reason for the change. The audit trail will track any successful
import action.
Figure 6–68: Audit Trails Group
Table 6–87: Columns of the Audit Trails Group table
Column Description
User Name of the user who changed an entry.
Date Shows the date when the change was made.
Item Shows the changed field/function.
From Original value.
To New value.
Reason Shows the reason of change.
6. Software Functions
Page 6-88 LIAISON
®
XS - Instruction for use Rev. H
6.8.2 Sub Category Controls
In the sub category Controls, detailed information on the control definitions can be
accessed.
Figure 6–69: Sub category Controls
Table 6–88: Functions of the Control sub category
Function Description
Delete Deletes one or more selected control definitions
(see chapter 6.6.1.3).
Add Adds a new control definition (see chapter 6.8.2.2).
Export Exports a control definition to a file.
Import Imports a control definition from a file.
Scan Enables to scan a 2D bar-code of a control definition with a
handheld bar-code scanner and displays the read data
(see chapter 6.8.2.1). The control will be added to the list.
Details Shows details about a selected control definition
(see chapter 6.8.2.2).
Standard buttons For standard buttons (e.g. arrow buttons, lock, Print),
see chapter 6.3.
6. Software Functions
LIAISON
®
XS - Instruction for use Rev. H Page 6-89
Table 6–89: Columns of the controls table
6.8.2.1 Scan
The Control Scan Dialog guides the user to scan a 2D Barcode of a Control Definitions and
displays the read data.
When scanned, the read characters are displayed after the integrity has been checked.
Figure 6–70: Scan Dialog
Column Description
Name Shows the name of a control definition.
Control ID Shows the bar-code of the control reagents.
Lot No. Shows the lot number of the control reagents.
Expiry date Shows the expiry day of the control reagents.
Note: controls expire at midnight of the displayed date.
Manufacturer Shows the manufacturer of the control reagents.
Assays Shows all associated assays.
6. Software Functions
Page 6-90 LIAISON
®
XS - Instruction for use Rev. H
6.8.2.2 Add Control/ Control Details
Enables user to add a new control to the LIAISON
®
XS system.
The Control Details display shows detailed information about a control definition.
Several fields can be edited.
Figure 6–71: Control Details
Table 6–90: Control Details buttons
Controls can not be defined for logical combi assays: they could not result in a numerical
result, therefore controls for logical combi assays are not supported by the system.
Function Description
Add Opens the Select Assay dialog to associate a new assay to
control.
The dialog shows all the assays that can be associated; already
associated assays are not reported. (Note: Those assays that do
not provide any numerical result are not listed as they cannot be
compared against any range).
Disabled if control was scanned.
Delete Deletes the currently selected assay data control definition from
the database.
Disabled if control was scanned.
Standard buttons For standard buttons (e.g. arrow buttons, lock, Print), see
chapter 6.3.
6. Software Functions
LIAISON
®
XS - Instruction for use Rev. H Page 6-91
Table 6–91: Fields on left side
Control Data Group
Table 6–92: Columns of the controls table
The Manufacturer Range cannot be changed if the control is acquired via 2D barcode.
Function Description
Name Name of the control definition. The control Name in combination
with the Lot Number must be unique. Any sequence of
alphanumeric characters (spaces, “-” and “/” are allowed) can be
entered as a control Name.
Control ID Bar-code of the control.
Lot No. Lot number of the control.
Expiry date Expiration day of the control.
Note: controls expire at midnight of the displayed date.
Manufacturer Manufacturer of the control.
Assay list Shows all associated assays.
The fields on the left side of the Control Details dialog cannot be changed if acquired via
2D barcode.
Column Description
Type To define whether this is an Accuracy or a Precision control.
Manufacturer Range The low and high limit of this control definition in user defined
units (result is expected to be in this range).
User Range The low and high limit of the reference range for this control, in
user unit.
Target CV Contains the target value for the variation coefficient.
Replicates Defines a number of replicates to be used for control samples.
If empty, the Control Replicates for the related assay is used.
Frequency Defines the logic the system will use to automatically start
controls.
• After Calibrations
• Every X Hours
• Every Y Tests
• Integral Begin
• Ancillary Begin
• With STAT
In case the control is not loaded when required by one of these
rules, a message will be issued.
For assays that have an assay range lower limit defined, a control range lower limit set
to 0 would cause the flags QL/UL to be reported whenever the result exceeds the assay
range lower limit. Otherwise, a control range lower limit left empty does not cause a flag.
6. Software Functions
Page 6-92 LIAISON
®
XS - Instruction for use Rev. H
6.8.3 Sub Category Groups
In the subcategory Groups, there is the possibility to include assays in groups. It is
necessary to include an assay in a group to be able to assign manually a patient sample to
such assay.
Figure 6–72: Sub category Groups
Functions Description
Delete Deletes one or more selected assay groups
(see chapter 6.6.1.3).
Add Shows the Group Details display to add a new assay group
(see chapter 6.8.3.1).
Export Exports a group definition to a file.
Import Imports a group definition from a file.
Up/Down Moves the currently selected group one line up/down and
changes the page number accordingly
Details Shows the Group Details display to show or edit the selected
assay group (see chapter 6.8.3.1).
Standard buttons For standard buttons (e.g. arrow buttons, lock, Print) see
chapter 6.3.
6. Software Functions
LIAISON
®
XS - Instruction for use Rev. H Page 6-93
6.8.3.1 Group Details: Details or Add
Figure 6–73: Group Details display
Table 6–93: Functions
Function Description
Assay Selection Shows all available assays (unless they are prevented by
usage). Tap on the assay button to assign it to the group.
Assay Group The Assay Group shows the name of all assigned assays
(upto15).
Group Name Name of the assay group. The assay group name must be
unique.
Page Number Used to display the groups in a specific order in the Group page.
This field is mandatory and must be unique.
Standard buttons For standard buttons (e.g. arrow buttons, lock, Print) see
chapter 6.3.
6. Software Functions
Page 6-94 LIAISON
®
XS - Instruction for use Rev. H
6.8.4 Sub Category Rerun Matrix
In the subcategory Rerun Matrix, there is the possibility to indicate, modify or generate the
rerun rules.
Figure 6–74: Sub category Rerun Matrix
Table 6–94: Functions of the Rerun Matrix sub category
Table 6–95: Columns of the rerun matrix table
Function Description
Delete Deletes one or more selected rerun rules (see chapter 6.6.1.3).
Add Shows the Rerun Rule Details display to add a new rerun rule
(see chapter 6.8.4.1).
Export Exports one or more selected rerun rules to a file.
Import Imports one or more selected rerun rules from a file.
Details Shows the Rerun Rule Details display to show or edit the
selected rerun rule (see chapter 6.8.4.1).
Standard buttons For standard buttons (e.g. arrow buttons, lock, Print) see
chapter 6.3.
Column Description
Rerun Rule Name Shows the name of the rerun rules. The rerun rule name must be
unique.
Assays Shows the assay(s) that shall trigger the rule.
Assay To Run Shows the assay that is launched if the conditions are satisfied.
Dilution Dilution factor assigned to the assay to be run.
Status Shows the status (Enabled or Disabled) of the rerun rule.
6. Software Functions
LIAISON
®
XS - Instruction for use Rev. H Page 6-95
6.8.4.1 Rerun Rule Details: Details or Add
Figure 6–75: Rerun Rule Details display
Table 6–96: Functions
Function Description
Name Name of the rerun rule. The rerun rule name must be unique.
Enabled / Disabled Allows disabling a rerun rule without deleting it.
Standard buttons For standard buttons (e.g. arrow buttons, lock, Print) see
chapter 6.3.
6. Software Functions
Page 6-96 LIAISON
®
XS - Instruction for use Rev. H
Conditions Group
Table 6–97: Functions of the Conditions group
Actions Group
Table 6–98: Functions of the Actions group
Function Description
1
st
Assay
Mandatory assay for the rerun rule.
Assay 1
Tap on the button to open a selection dialog. Pick up an assay in
this dialog.
Range 1
Specifies the low and/or high limit of the condition range. If empty
the LIAISON
®
XS software will treat this as “do not care” and
consider this condition as always true.
Qualitative Label 1
Specifies the qualitative label of the assay. If empty the
LIAISON
®
XS software will treat this as “do not care” and
consider this condition as always true.
2
nd
Assay
Optional assay for the rerun rule.
Assay 2
Tap on the button to open a selection dialog. Pick up an assay in
this dialog.
Range 2
Specifies the low and high limit of the condition range. If empty
the LIAISON
®
XS software will treat this as “do not care” and
consider this condition as always true.
Qualitative Label 2
Specifies the qualitative label of the assay. If empty the
LIAISON
®
XS software will treat this as “do not care” and
consider this condition as always true.
And If both assays are defined, both conditions must be fulfilled.
If both first and second assay are defined, both conditions must be fulfilled.
If the result falls outside the assay range, the assay range limit is used to evaluate the
rerun rule.
Function Description
Dilution Factor Dilution Factor assigned to the assay.
Repetitions Defines the number of times that assay shall be run for that
sample.
Priority Whether the rerun rule is to be scheduled with Normal or STAT
priority.
Assay Tap on the button to open a selection dialog. Pick up an assay
(never run assays are excluded) in this dialog.
6. Software Functions
LIAISON
®
XS - Instruction for use Rev. H Page 6-97
6.8.5 Sub Category Profiles
In the subcategory Profile, there is the possibility to arrange several assays as a profile.
If the user assigns assays to samples, they can select a profile instead of all affected
assays. In this way, it is possible to simplify recurrently test arrangements.
Figure 6–76: Sub category Profiles
Tests that have been started via a Rerun Rule will not be evaluated against any Rerun
Rule.
Samples, that have been erroneously removed while they were displayed as active, may
not trigger a Rerun Rule evaluation even after reloading.
The rerun rule evaluation will not be performed if the result of one of the two conditions is
archived (manually or automatically) before the result of the other condition is done.
The rerun rule is effective only if it was stored as enabled before the start of the involved
tests.
6. Software Functions
Page 6-98 LIAISON
®
XS - Instruction for use Rev. H
Table 6–99: Functions of the Profiles sub category
Table 6–100: Columns of the profiles table
6.8.5.1 Profile Details: Details or Add
Figure 6–77: Profile Details display
Function Description
Delete Deletes one or more selected profiles (see chapter 6.6.1.3).
Add Shows the Profile Details display to add a new profile
(see chapter 6.8.5.1).
Export Opens the Export display to export one or more entries to a file
(see chapter 6.6.1.1).
Import Imports a assay profile from a file.
Details Shows the Profile Details display to show or edit the selected
profile (see chapter 6.8.5.1).
Standard buttons For standard buttons (e.g. arrow buttons, lock, Print) see
chapter 6.3.
Column Description
Profile Name Shows the name of the profile.
Assays Shows all assigned assays.
6. Software Functions
LIAISON
®
XS - Instruction for use Rev. H Page 6-99
Table 6–101: Fields of Profile
6.8.6 Sub Category Senders
In the subcategory Sender, it is possible to store information about the sample source.
Figure 6–78: Sub category Senders
Table 6–102: Functions of the Sender sub category
Function Description
Assays Shows all assigned assays
Profile Name Name of the profile. The assay profile name must be unique.
Standard buttons For standard buttons (e.g. arrow buttons, lock, Print) see
chapter 6.3.
Function Description
Delete Deletes one or more selected sender (see chapter 6.6.1.3).
Add Shows the Sender Details display to add a new sender.
Details Shows the Sender Details display to show or edit the selected
sender.
Standard buttons For standard buttons (e.g. arrow buttons, lock, Print) see
chapter 6.3.
6. Software Functions
Page 6-100 LIAISON
®
XS - Instruction for use Rev. H
Table 6–103: Columns of the sender table
6.8.6.1 Sender Details: Details or Add
Figure 6–79: Sender Details
Table 6–104: Functions
Column Description
Code Code of the doctor.
Name Name of the doctor.
Section Department
City Address of the doctor - city.
Function Description
City Address of the doctor - city.
Code Code of the doctor.
Comment Comment to the entry.
Name Name of the doctor.
Phone Telephone number of the doctor.
Section Department
Street Address of the doctor - street.
Cancel Close the screen.
Add Shows the Sender Details display to add a new sender.
6. Software Functions
LIAISON
®
XS - Instruction for use Rev. H Page 6-101
6.9 Main Category System
The main category System allows the user to adapt the LIAISON
®
XS system to specific
circumstances and needs.
6.9.1 Sub Category Account
The subcategory Account can be used to manage the system accounts to access the
software and its functionalities.
The access (edit/visualize) to specific functionalities and pages depends on the Access
Rights associated to each account.
All privileges available for a given Access Right level are also available to Access Right with
higher level, with the exception of the Patient Privilege (see chapter 6.9.1.2).
The Current User tab enables to change the user’s own password or to log off the
LIAISON
®
XS software.
The Users tab enables to add a new user or to change the rights of a user.
6.9.1.1 Current User
Shows the current user. The password of the current user can be changed here.
Figure 6–80: Sub category Account
6. Software Functions
Page 6-102 LIAISON
®
XS - Instruction for use Rev. H
Figure 6–81: Change Password
Change Password
Table 6–105: Functions of the Change password dialog
Function Description
Name The Name of the currently logged in user.
Access Rights The Access Rights of the currently logged in user
(see chapter 6.9.1.2).
Change Password Opens the Change Password Dialog and allows the user to
change his own password.
Logout Allows current user to log off.
If the user logs out while the instrument is running, the run will
continue. User intervention on the hardware side (covers,
containers...) will be traced, but not associated with a specific
user.
Standard buttons For standard buttons (e.g. arrow buttons, lock, Print) see
chapter 6.3.
Function Description
Change Applies the change of the password.
Enabled only if all the fields have a valid value inserted.
The new and the old password must not be identical.
Old Password Each character is displayed as “*” and not logged as plain text.
New Password Field for the new password. Each character is displayed as “*”
and not logged as plain text.
Password shall be from 8 to 20 characters long, shall only
contain alphanumerical and the following character !”#$%&'()*+,-
./:;<=>?@[\]^_`{|}~
The password is case sensitive.
Confirm Password Field to re-enter the new password.
Each character is displayed as * and not logged as plain text.
Standard buttons For standard buttons (e.g. arrow buttons, lock, Print) see
chapter 6.3.
6. Software Functions
LIAISON
®
XS - Instruction for use Rev. H Page 6-103
6.9.1.2 Users
The purpose of the Users tab is to add a new user or change the rights of users with lower
Access Rights than the user currently logged in.
Figure 6–82: Tab Users
Table 6–106: Functions of the Accounts sub category
Table 6–107: Functions of the User Setup display
Function Description
Delete Deletes the selected users after confirmation popup.
Add Opens the Details Dialog for a new user.
Details Opens the Details Dialog of the currently selected user.
Standard buttons For standard buttons (e.g. arrow buttons, lock, Print) see
chapter 6.3.
Function Description
User Name Name of the user used to login. The user name must be unique.
Any sequence of alphanumeric characters (spaces are not
allowed) can be entered as a user name.
The user name is not case sensitive.
Access Rights Shows privilege level of the user (3 levels).
Patient Privilege Defines, if the user has the privilege (Yes or No) to view patient
demographical data.
Standard button For standard buttons (e.g. arrow buttons, lock, Print) see
chapter 6.3.
6. Software Functions
Page 6-104 LIAISON
®
XS - Instruction for use Rev. H
6.9.1.3 Details Users
Figure 6–83: Details User
Table 6–108: Details User
Function Description
Name Enabled only for new users, disabled if an existing user is
changed.
Expiry Period Time during which the password remains unchanged. After this
interval the password expires and must be changed.
Password never
expires
If checked, the user does not have to change the password
Privilege Level Available values are:
• Lab User
• Lab Supervisor
• Administrator
If the edited user is currently logged in user, then all levels below
and equal to the current user are displayed.
Else, only the levels below the currently logged user are
displayed.
Patient Privilege Gives permissions to the user to see and edit the patient
demographic data.
Standard button For standard buttons (e.g. arrow buttons, lock, Print) see
chapter 6.3.
6. Software Functions
LIAISON
®
XS - Instruction for use Rev. H Page 6-105
6.9.2 Sub Category Applications
The subcategory Applications can be used to start additional applications.
Figure 6–84: Sub category Applications
Table 6–109: Functions of the Applications sub category
Function Description
QC Starts the long term quality control (QCStats) application.
Opens the QCStats Software in the foreground and keeps the
LIAISON
®
XS Software open in the background.
Standard buttons For standard buttons (e.g. arrow buttons, lock, Print)
see chapter 6.3.
6. Software Functions
Page 6-106 LIAISON
®
XS - Instruction for use Rev. H
6.9.3 Sub Category Backup
The sub category Backup provides the option to make a backup of the LIAISON
®
XS
system files (e.g. database and settings files).
Figure 6–85: Sub category Backup
Figure 6–86: Time based filter dialog
The backup function is only available while the LIAISON
®
XS system is in Standby,
Ready, Halted, Disconnected status, otherwise all controls and buttons are disabled.
6. Software Functions
LIAISON
®
XS - Instruction for use Rev. H Page 6-107
Table 6–110: Functions of the Backup sub category
Table 6–111: Columns of the backup table
Function Description
Information line
Shows the status of the LIAISON
®
XS system.
Additionally the software shows a second line with information
about the creation or copying progress (e.g. Backup finished with
success).
Backup Type
Create
Create Allows user to create a new backup.
1. Select the backup type:
• Access_Rights: Saves only files to determine the defined
accounts.
• All: Saves all files relevant for the software (e.g. Databases,
Logs).
• All_Database: Saves all databases for results, events, and
system settings.
• TroubleshootingShort: Saves a selection of files useful for a
general troubleshooting.
• TroubleshootingComplete: Saves all files useful for
troubleshooting activities.
• IoT: Saves a selection of files useful for IoT troubleshhoting.
• LIS: Saves all files generated by host communication and
related settings.
• Results: Saves a file called FinishedJobs.txt that contains the
cumulative history of successfully completed tests.
• QC: Saves a selection of files useful for troubleshooting of QC
Software.
• Pre-SW_Installation: Saves a selection of files useful for
installation troubleshooting.
2. Press on the Create button.
Upon selection of an applicable backup type, the dialog in
figure 6–86 is opened to allow the user to apply a time based filter.
The selected backup type will include files on the basis of the
selected period.
Copy to
Copy
Allows user to copy a backup file on an external storage device,
or a network path.
1. Select the external storage device, or network path in the
Select a Backup to Copy list.
2. Select an existing backup file in the backup file table.
3. Press on the Copy button.
Standard buttons For standard buttons (e.g. arrow buttons, lock, Print) see
chapter 6.3.
Column Description
No. Number of the backup.
Name Name of the backup file.
Size Needed storage space on external device.
6. Software Functions
Page 6-108 LIAISON
®
XS - Instruction for use Rev. H
6.9.4 Sub Category Connectivity
The sub category Connectivity is used to configure the connection between the
LIAISON
®
XS system and LIS and IoT.
The connection between the LIAISON
®
XS system and a LIS enables the interchange of
test requests and test results. Laboratory Information System (LIS) is often called a Host.
Note: For details about the interface protocol ask local service support.
The connection between the LIAISON
®
XS instrument and a IoT allows the transmission
of telemetry data and files to support troubleshooting activities. It also allows to receive,
upon request, instrument dedicated files (e.g. Instructions for Use, Assay Protocols, User
Manual, see chapter 6.3.1).
Figure 6–87: Sub category Connectivity tab
It is recommended to periodically (e.g. weekly) create and copy a Database backup on an
external storage device using the functions from Table 6–110, in order to recover the
database if needed.
Before enabling the interface with IoT, ensure that Internet connection is available,
otherwise a PC reboot may be necessary.
In the associated events (reported in chapter 8), IoT may be reported as DoT, DiaSorin of
Things.
6. Software Functions
LIAISON
®
XS - Instruction for use Rev. H Page 6-109
Table 6–112: Functions of the Connectivity tab
6.9.4.1 IoT Details
Figure 6–88: IoT Details
Table 6–113: Iot details buttons
Function Description
Host Name assigned to the host.
Instrument Name assigned to the instrument. It is used to verify that a
transmission is intended for this instrument.
Enable/Disable
Enables/disables the connection with a host or the interface with
IoT
Details
Shows and allows to customize the details of IoT/LIS connection
Function Description
Cancel Closes the dialog and discard all changes.
Store Closes the dialog and stores all changes.
6. Software Functions
Page 6-110 LIAISON
®
XS - Instruction for use Rev. H
Table 6–114: Iot details options
6.9.4.2 LIS Details
Figure 6–89: LIS Details
Function Description
IoT Enabled:
I am hereby
authorized, through a
valid data process
order being in place,
to connect and
transmit data into the
IoT System.
Switches the State to Enabled/Disabled
Allow outgoing data If enabled, transmission of telemetry data (any kind of data
besides File Transmission) is enabled.
Allow file reception If enabled, the instrument can retrieve files from DiaSorin online
repository (e.g. Instructions for Use, Assay Protocols, Manuals).
Allow file request If enabled, IoT can request files from the instrument, including
troubleshooting collections for a given time frame.
Allow sending
Sample IDs
If enabled, Sample IDs (included in events and telemetry data)
are transmitted. If disabled, the Sample ID is not transmitted.
6. Software Functions
LIAISON
®
XS - Instruction for use Rev. H Page 6-111
Table 6–115: LIS Details
Options
Figure 6–90: Options
Table 6–116: Functions of the Options tab
Function Description
LIS Enabled Switches the state to Enabled/Disabled
Instrument ID Defines the instrument name
Host ID Defines the host name
Connection Serial and TCP/IP
Standard buttons For standard buttons (e.g. arrow buttons, lock, Print) see
chapter 6.3.
Function Description
Timeout (Query) Countdown value for the Download Orders dialog.
Result Flag Style Defines how the flags are transmitted:
• Short: only the symbol is transmitted
• Long: the flag verbose description is transmitted.
Enable Manufacturer
Record
Sends additional information (reagent kit no., reagent expiration
date, reagent lot no., calibration ID, sample rack lane, sample
position in the rack) to the host.
Host Query Mode Scanned and manually entered tube barcodes cause a request
for tests to the host.
Send Results on
Archiving
When a result is archived, it is automatically send via LIS.
Respond to LIS
Query for Results
The instrument responds to queries for results.
6. Software Functions
Page 6-112 LIAISON
®
XS - Instruction for use Rev. H
6.9.5 Sub Category Settings
The sub category Settings is used for run mode definitions, general and localization
settings. The information reported are not editable, to edit them press the button Edit.
Figure 6–91: Sub category Settings
Table 6–117: Function of the sub category Settings
Table 6–118: Groups of the sub category Settings
Function Description
Edit Open the Edit Settings to change settings.
Field Description
Beeper Shows the beeper settings.
Language Shows languages and formats (e.g. time and date format).
Backup Shows the auto-backup options.
Others Shows general settings (e.g. automatic procedure times,
processing mode).
6. Software Functions
LIAISON
®
XS - Instruction for use Rev. H Page 6-113
Beeper
Figure 6–92: Beeper Settings
Table 6–119: Beeper
Function Description
Disable Failed
Results Beeper
Disable the beeper for single occurrence events (e.g. aborted
tests).
Disable System Error
Beeper
Disable the beeper for system error (e.g. resource availability
events).
Disable Fatal Error
Beeper
Disable the beeper for fatal error.
Disable Sample
Loading Beeper
Disable the beeper when loading a sample rack.
Disable Info Beeper Disable the beeper for info events (e.g. offline reagents events).
Auto mute
Interval...minutes
Defines a time span, after which the audible alarm will be
switched off automatically. If set to “0” then the alarms will not be
switched off.
Volume Defines the volume of the audible alarm.
Values: High, Medium, Low.
6. Software Functions
Page 6-114 LIAISON
®
XS - Instruction for use Rev. H
Language
Figure 6–93: Language Settings
Table 6–120: Language
Function Description
Software Language The language of the software.
IFU Language The language preference that is used by the system to download
the IFU.
Note: IFU are provided in the preferred language only if such
language is available for the defined country, otherwise they will
be provided in one of the available languages for the defined
country.
Date Format Date format used in the software, among the following options:
• MM/DD/YYYY
• DD.MM.YYYY
• YYYY-MM-DD
Time Format Date format used in the software, among the following options:
• 24 hrs
• 12 hrs AM-PM
Decimal Point Set the type of the decimal point, either “.” or “,”.
Temperature Unit Temperature information can set in either Celsius or Fahrenheit.
Any change applied in the Language tab becomes effective after the application restart.
The System Country Code is visualized in Language tab and cannot be edited.
6. Software Functions
LIAISON
®
XS - Instruction for use Rev. H Page 6-115
Backup
Figure 6–94: Sub category Settings- Backup
Table 6–121: Backup
Function Description
Auto-Backup If unchecked, all items below are disabled.
Frequency The frequency in days when Auto Backup is performed, i.e. when
old Archived results are moved to the History database and they
are accessible in the History page (see chapter 6.6.9).
Archive Retention
Time
If results have been archived since a number of days equal or
greater than the defined days, they are moved from Archived to
History.
Backup and
Historicization Time
After this time of the day, in the current time settings, the system
creates a backup copy of the Archive and History databases and
then moves the results from Archived to History as soon as the
system is not in Initializing, Running, Maintenance.
If a network path is defined (ask to the authorized service
technicians to define it), the system will save a copy of the same
backup on it.
6. Software Functions
Page 6-116 LIAISON
®
XS - Instruction for use Rev. H
Others
Figure 6–95: Sub category Settings- Others
Table 6–122: Others
Function Description
Mode Shows Random Access or Batch, with the following meaning:
• in Random Access, the system will schedule first all samples
from one rack in order to release it as soon as possible, then
move to the next rack
• in Batch, the system will schedule all sample loaded in the
sample area in order to complete the whole batch as soon as
possible.
Sample Archiving Allows selecting if patient sample/calibrator results are manually
or automatically moved to the Archived page.
Control Archiving Allows selecting if control results are manually or automatically
moved to the Archived page.
Auto log-off
after...minutes
If checked, the auto log-off time field unlocks, allowing setting a
time interval for auto log-off.
After this time is passed without user interaction, the log-in page
will be prompted.
Daily Init Time of the daily initialization.
Autoresume Time at which the system switches from standby to ready and
primes resources (i.e system liquid, starters and wash buffer)
Maintenance Due
Time
Time when a maintenance task becomes due.
It is recommended to set the Autoresume time at least 30 minutes later than the Daily Init
time
6. Software Functions
LIAISON
®
XS - Instruction for use Rev. H Page 6-117
6.9.6 Sub Category Test Statistics
The sub category Test Statistics can be used to get information about which among the
started tests are failed or successfully completed.
Figure 6–96: Sub category Test Statistics
Table 6–123: Functions of the Test Statistics tab
Table 6–124: Columns of the test statistics table
Function Description
Export Exports the test statistics to a file.
Filter Opens the Select Filter display (see chapter 6.6.1.4).
Standard buttons For standard buttons (e.g. arrow buttons, lock, Print) see
chapter 6.3.
Column Description
Assay Name of the assay.
Successful Cals +
Failed Cals
Number of successfully or unsuccessfully performed calibrator
determinations.
Successful Controls
+ Failed Controls
Number of successfully or unsuccessfully performed control
determinations.
Successful Samples
+ Failed Samples
Number of successfully or unsuccessfully performed patient
sample determinations.
6. Software Functions
Page 6-118 LIAISON
®
XS - Instruction for use Rev. H
6.9.7 Sub Category Versions
The sub category Versions is used to inform the user about the LIAISON
®
XS software and
the LIAISON
®
XS instrument firmware versions.
Figure 6–97: Sub category Versions
Table 6–125: Functions of the Versions sub category
Table 6–126: Columns of the version tables
Function Description
Serial Number
Shows the serial number of the LIAISON
®
XS instrument.
LIAISON
®
XS Version Shows the version of the current LIAISON
®
XS software version.
Copyright Button Shows third party copyright.
Generics Version Number of version of the generics.
Dilutions Version Number of version of the dilution.
Standard buttons For standard buttons (e.g. arrow buttons, lock, Print) see
chapter 6.3.
Column Description
PC Software Module
Shows the name of several modules of the current LIAISON
®
XS
software.
Firmware Module
Shows the name of the modules of the LIAISON
®
XS instrument.
Version Shows the module version.
6. Software Functions
LIAISON
®
XS - Instruction for use Rev. H Page 6-119
6.10 Main Category Diagnostics
In the main category Diagnostics and its subcategories, information about the
LIAISON
®
XS system can be found.
6.10.1 Sub Category Options
Figure 6–98: Sub category Options
Perform tasks from Diagnostics only guided by local support.
6. Software Functions
Page 6-120 LIAISON
®
XS - Instruction for use Rev. H
Table 6–127: Functions of the Options sub category
Function Description
Start Barcode
Scanner
Sample bay scanner on standby. May be used to switch on the
scanner if the sample flap sensor is broken.
Read Barcode Scanner ready to read. Clears the field “Internal/external
scanner content” and enables it to accept the data read by the
external barcode scanner.
Internal/external
scanner content
Any Sample Rack insertion disables this field, clears and fills it
with data read in the rack inserted
Fill Incubator It fills the incubator with cuvettes.
Enabled only in Status Ready.
Empty Incubator Starts a command to empty the incubator.
Enabled only in Status Ready.
Low-Level Command Input option for commands to the instrument. Use the Send button
to send the command.
Send Send low level command to the analyzer.
This may bring the system in Not Initialized mode, to initialize the
system press the button Leave.
Printer is online/
offline
Reports the printer status as reported by the operating system.
Standard buttons For standard buttons (e.g. arrow buttons, lock, Print) see
chapter 6.3.
The function “Empty incubator” disposes the cuvettes present in the incubator without
washing them in the Washer.
6. Software Functions
LIAISON
®
XS - Instruction for use Rev. H Page 6-121
6.11 Main Category Maintenance
The main category Maintenance and its subcategories allow performing necessary
maintenance tasks to obtain the system performance.
6.11.1 Sub Category Tasks
In the subcategory Tasks, maintenance tasks can be managed or started. The individual
maintenance tasks can be generated in such a way that they can be started either if
required or on schedule. As soon as a scheduled maintenance task is due, this is indicated
by a flashing Maintenance main category tab or Tasks subcategory tab.
Figure 6–99: Sub Category Tasks
Table 6–128: Functions of the Tasks sub category
Function Description
Perform Opens the Perform Task dialog (see chapter 6.11.1.2) and starts
the selected maintenance task. Follow the instructions on the
dialogue.
The Perform button is disabled if the selected maintenance task
cannot start (e.g. when the system is in Halted)
Filter Opens the Select Filter display (see chapter 6.6.1.4)
Details Shows details about a selected maintenance task
(see chapter 6.11.1.1).
Standard buttons For standard buttons (e.g. arrow buttons, lock, Print) see
chapter 6.3.
6. Software Functions
Page 6-122 LIAISON
®
XS - Instruction for use Rev. H
Table 6–129: Columns of the Tasks table
6.11.1.1 Maintenance Task Details
Figure 6–100: Maintenance Task Details
Table 6–130: Maintenance Task Details
Column Description
Name Name of the maintenance task.
Interval Displays the interval for the maintenance task in days or nothing
(‘As needed’) if there is no interval defined.
Due Date Shows the date when the next run for the maintenance task is
due. The cell is empty if interval is 'As Needed’.
Due Shows if the task is due or not (“Yes” or nothing)
Column Description
Name Name of the maintenance task.
Revision The Revision of the task
Description Description of the task
Time Interval Interval for the maintenance task in days
6. Software Functions
LIAISON
®
XS - Instruction for use Rev. H Page 6-123
6.11.1.2 Perform a Maintenance Tasks
Figure 6–101: Perform Maintenance Tasks
Table 6–131: Functions of the Perform Task display
Table 6–132: Functions of the Perform Task display
Function Description
Accept To accept a selected message by clicking Accept button.
Mute Alarm Switches off the instrument beeper.
Abort Aborts the maintenance task procedure and closes the Perform
Task display.
Done This button is prompted after the last step is finished or in case
maintenance task failed. Allows closing the Perform Task
display.
Function Description
Task The Name and Revision Index of the Task.
Started by The Name of the user who started the Task.
Start The Date and Time when the task was started.
Procedure The complete procedure list.
Perform Task Wizard Shows detailed information about the current performed step,
including the time required to complete the ongoing step and the
complete procedure.
Standard buttons For standard buttons (e.g. arrow buttons, lock, Print) see
chapter 6.3.
6. Software Functions
Page 6-124 LIAISON
®
XS - Instruction for use Rev. H
6.11.2 Sub Category Log
The sub category Log shows a list with all maintenance task entries, either successfully or
unsuccessfully performed.
Figure 6–102: Sub category Log
Table 6–133: Functions of the Log sub category
Function Description
Export Opens the dialog to export one or more selected maintenance
log entries to a text file (see chapter 6.6.1.1).
Filter Opens the Select Filter display (see chapter 6.6.1.4).
Details Open the Details Sub Page of the currently task containing the
following items:
• The Name of the task
• The Revision of the task
• The Date & Time the task was started
• The Status of the selected task
• The User which started the task
In addition the Details page contain per step the list of the
measured replicates if any (see chapter 6.11.2.1).
Standard buttons For standard buttons (e.g. arrow buttons, lock, Print) see
chapter 6.3.
6. Software Functions
LIAISON
®
XS - Instruction for use Rev. H Page 6-125
Table 6–134: Columns of the Log table
6.11.2.1 Log Details
Figure 6–103: Log Details
Table 6–135: Log Details
Column Description
Name Name of the maintenance task.
Revision Revision number.
Date Shows the date and time when the maintenance task was
performed.
Status Shows the result Done or Failed of the maintenance task.
Started by Shows the name of the user who started the maintenance task.
Column Description
Name Name of the maintenance task.
Revision Revision number.
Date Shows the date and time when the maintenance task was
performed.
Status Shows the result Done or Failed of the maintenance task.
Started by Shows the name of the user who performed the maintenance
task.
Step* Maintenance step.
Mean* Mean value
CV* Standard deviation
RLUs* Measurement results.
* filled only if a measure step is performed
6. Software Functions
Page 6-126 LIAISON
®
XS - Instruction for use Rev. H
6.12 Main Category Status
In the main category Status, the filling level of the different containers, bottles and waste
containers can be accessed. Additionally, there is the possibility to check the temperatures
of the individual modules. The loading of the system with cuvettes and disposable tips is
also performed in this main category.
6.12.1 Sub Category Summary
In the sub category Summary, the indication of the temperatures in the individual modules,
the filling level of the different containers, bottles, waste container and the number of
cuvettes and tips available are reported.
If a resource is not available (e.g. Absent, Depleted) main toggle Status and sub toggle
Summary flash.
Figure 6–104: Sub category Summary
6. Software Functions
LIAISON
®
XS - Instruction for use Rev. H Page 6-127
Plastics Group - Cuvettes
Shows the number of cuvettes in the drawer and in the incubator.
Table 6–136: Function Plastics - Cuvettes
Table 6–137: Symbol Consumables Cuvettes
Plastics Group - Tips
Shows the number of disposable tips.
The number is given in brackets if the drawer is not inserted or not assigned.
Table 6–138: Symbol Disposable Tips
Function Description
Drawer Displays the number of cuvettes in the cuvette trays.
The number is given in brackets if the drawer is not inserted or not
assigned.
Incubator Displays the number of not used, clean cuvettes in the Incubator.
Symbol Meaning
• Cuvettes in the drawer and in the incubator are available and
above the availability threshold
• Absent
Not detected by the presence sensor e.g. open drawer
• Depleted, no cuvette available
• Less than the availability threshold of cuvettes available in
the drawer
Availability Threshold Cuvettes = 2
Symbol Meaning
• Tips in the drawer are available and above the availability
threshold
• Absent
Not detected by the presence sensor e.g. open drawer
• Depleted, no tips available
Availability Threshold Disposable Tips
= 0
6. Software Functions
Page 6-128 LIAISON
®
XS - Instruction for use Rev. H
Starters Group
Shows remaining shots of the loaded starter 1 and 2. The counter decreases after every
injection.
The Starters are primed automatically during Resume (or before starting a routine) if they
are Not Primed, one cuvette from the tray is available, Liquid Waste is below red phase
and Solid Waste has enough available space.
If the prime fails, then the Starters stay in Not Primed.
Table 6–139: Symbol Starter
System Fluids Group - Wash Buffer
The Wash Buffer is primed automatically during Resume (or before starting a routine) if it
is Not Primed, one cuvette from the tray is available, Liquid Waste is below red phase and
Solid Waste has enough available space.
If the prime fails, then the Wash Buffer stays in Not Primed.
Table 6–140: Symbols System Fluids-Wash Buffer
Symbol Meaning
• Absent
• RF-Tag not read
• Depleted
• if not primed: the number of remaining shots is not enough to
perform a prime
• if primed: the number of remaining shots is not enough to
start a routine Availability Threshold Starters
= 4
• Not primed
• Expired
If Starters are not primed and the system is in Ready, the main
and sub toggles flash
• Primed
• Above availability threshold
• Error
○ Starter in error
○ Wrong CRC
Symbol Meaning
• Absent
• Not primed
• Successfully primed
• Above red phase
• Depleted
• Usable only for ongoing jobs
6. Software Functions
LIAISON
®
XS - Instruction for use Rev. H Page 6-129
System Fluids Group - System Liquid
The System Liquid is primed automatically during Resume (or before starting a routine) if it
is Not Primed and Liquid Waste is below red phase.
If the prime fails, then the System Liquid stays in Not Primed.
The System Liquid is also used for periodical SPOLV rinsing in Standby or Ready status,
if it is above red phase and the Liquid Waste is not full.
Table 6–141: System Fluids- System Liquid
Waste Group - Liquid Waste
Table 6–142: Used symbols
Waste Group - Solid Waste
Shows the number of cuvettes disposed in the Solid Waste.
Table 6–143: Used symbols
Table 6–144: Functions of the Waste group
Symbol Meaning
• Absent
• Not primed
• Successfully primed
• Above red phase
• Depleted
• Usable only for ongoing jobs
Symbol Meaning
• Absent
• Below red phase
• Full
• Usable only for ongoing jobs
Symbol Meaning
• Absent (solid waste drawer
removed)
• Loaded
• Below availability threshold
• Loaded
• Above availability threshold
Function Description
Reset Sets the number of Cuvettes in the Waste to 0.
6. Software Functions
Page 6-130 LIAISON
®
XS - Instruction for use Rev. H
Temperatures
For the following modules the current temperature and the allowed range are given:
• Reaction
• Reagents
• Injection 1
• Injection 2
• Sample (no allowed ranges displayed)
The main and sub-toggle flash and the temperature is displayed in red if it falls outside its
range.
The values are displayed using the selected unit (see chapter 6.9.5).
6.12.2 Sub Category Plastics
There are four trays for cuvettes and two plates for tips.
In Running mode the system will place one cuvette in the incubator every cycle if a cuvette
from a tray and an empty slot in the outer ring are available.
In the subcategory Plastics, the system can be filled with disposable tips and cuvettes.
Figure 6–105: Sub category Plastics, closed drawer
6. Software Functions
LIAISON
®
XS - Instruction for use Rev. H Page 6-131
Clear and Fill buttons are displayed by opening the drawer for the tips and cuvettes.
The selected Cuvette or Disposable Tip Tray is displayed on the right side.
Clicking on a single slot inverts the occupation (present/not present).
Plastics occupation can be set also by dragging a rectangle over the tray/plate.
Figure 6–106: Sub category Plastics, open drawer
Table 6–145: Functions of the Fill and Clear buttons
Function Description
Fill Trays Fills all 4 Cuvette Trays.
Clear Trays Empties all 4 Cuvette Trays.
Fill Plates Fills all 2 Disposable Tip Plates.
Clear Plates Empties all 2 Disposable Tip Plates.
Fill Tray/Plate Fills the selected tray/plate.
Clear Tray/Plate Empties the selected tray/plate.
Withdraw Visible only if the Drawer is inserted and in use.
When clicked, an indication will be displayed when it is safe to
remove the drawer.
This will unschedule all jobs in Placed status.
6. Software Functions
Page 6-132 LIAISON
®
XS - Instruction for use Rev. H
6.12.2.1 Refill Plastics drawer (while not in use)
Either empty trays/plates can be completely exchanged for full ones or individual places
can be assigned.
1. Select the page Status Plastics: the message “You can open the drawer for
loading” is displayed.
2. Open the drawer of the cuvettes and tips. The buttons Fill Tray/Plate and Clear
Tray/Plate are displayed.
3. Replace the tray/plate.
4. Select the tray/plate that has been filled by tapping it. The selected tray/plate is
also displayed on the right side. If assignment of individual places needs to be
modified, places can be individually selected on the right side.
5. Touch the button Fill Tray/Plate.
6. Close the drawer.
6.12.2.2 Refill Plastics drawer (while in use)
If the system is accessing the drawer, it is possible to suspend the access: the jobs in
“Scheduled” status will return in “Placed” status.
1. Select the page Status Plastics: the message “Do not open the consumable
drawer” is displayed
2. Click on the button Withdraw
3. Wait until the countdown ends and the message “You can open the drawer for
loading” is displayed
4. Open the drawer. The buttons Fill Tray/Plate and Clear Tray/Plate are
displayed.
5. Replace the tray/plate.
6. Select the tray/plate that has been filled by tapping it. The selected tray/plate is
also displayed on the right side. If assignment of individual places needs to be
modified, places can be individually selected on the right side.
7. Touch the button Fill Tray/Plate.
8. Close the drawer.
Note: if jobs were returned to “Placed”, it is necessary to press “Start” to process
them
6.12.2.3 Remove cuvettes trays or tips plates
1. Open the drawer of the cuvettes and tips. The buttons Refill Tray/Plate and
Clear Tray/Plate are displayed.
2. Remove the complete tray/plate.
3. Select the tray/plate by tapping it.
4. Touch the Clear Tray/Plate button.
5. Close the drawer.
6. Software Functions
LIAISON
®
XS - Instruction for use Rev. H Page 6-133
6.12.3 Sub category Needs
The sub category Needs gives an approximated overview of any needed reagent or
consumable, based on system estimations of the currently Placed/ongoing tests.
The page updates when pressing the Start button or pressing the Calculate button.
In case Starters/Wash Buffer/System Liquid are not primed, also the resources necessary
for priming are taken into account.
Figure 6–107: Sub category Needs
Table 6–146: Sub category Needs
Table 6–147: Columns of the Needs table
Function Description
Calculate Pressing the Calculate button updates the display.
Standard buttons For standard buttons (e.g. arrow buttons, lock, Print) see
chapter 6.3.
Column Description
Name Wash Buffer, System Liquid, Liquid Waste, Solid Waste, Starters,
Cuvettes, Tips and Reagents (kits and ancillaries).
Placed Needed for all jobs currently in placed.
Ongoing Needed for all jobs currently in scheduled or active.
Sum Sum of the values reported in Placed and Ongoing columns.
Not Booked The total available amount minus Sum. Negative Numbers are
highlighted and indicate that the resource is not sufficient for the
requested jobs.
For combi assays, in brackets is reported the amount calculated from the determination
available for the sons, considering combi type and the presence of lot locking.
6. Software Functions
Page 6-134 LIAISON
®
XS - Instruction for use Rev. H
Table 6–148: Meaning of Amount
Resource Amount
Ancillary • Each needed Ancillary create a row with Article Number
(no Lot or Serial Number).
• In case a specific Lot and Serial Number is required, an entry
with the needed Article Number, Lot Number and Serial
Number is created.
Cuvettes Number of cuvettes needed. Includes the clean cuvettes from
Incubator.
Tips Number of disposable tips needed.
Integral • Each needed Integral create a row with Assay Abbreviation
(no Lot or Kit Number).
• In case that a specific Lot or Kit number is required, an entry
with Lot and/or Kit Number is created.
Liquid waste Liquid waste volume needed for the required tests.
Solid Waste Available space needed for cuvettes in the solid waste.
Starter reagents Number of starter shots for the required tests.
Wash buffer Needed wash buffer volume for the required tests.
System Liquid Needed System Liquid volume for the required tests.
6. Software Functions
LIAISON
®
XS - Instruction for use Rev. H Page 6-135
6.12.4 Sub Category Inventory
The sub category Inventory shows a list of all loaded and calibrated integrals in the reagent
bay including the combi assays. The dialog is updated in regular intervals.
Disabled, offline, empty and expired reagents are not reported.
Figure 6–108: Sub category Inventory
Table 6–149: Columns of the Inventory table
Column Description
Assay-Lot Assay abbreviation and lot number of the integral.
Determinations Number of remaining determinations.
6. Software Functions
Page 6-136 LIAISON
®
XS - Instruction for use Rev. H
7. Maintenance
LIAISON
®
XS - Instruction for use Rev. H Page 7-1
7 Maintenance
In order to operate correctly, it is essential that the LIAISON
®
XS system is maintained in
accordance with the maintenance plan and procedures described in the instrument
software.
According to given scheduling the system prompts the user when maintenance tasks are
due, and it guides the user through the required procedure.
Carefully observe all required steps in order to ensure proper system functionality.
7.1 Safety and hints
See Biological Safety in chapter 1.6.6.
See Electrical safety in chapter 1.6.3.
Improper Maintenance Actions
Improper maintenance Actions can result in serious personal injuries and material
damage
• Follow all safety instructions in chapter 1.6 and in this chapter.
• Follow the work instructions stated by the software.
• Take off watches and jewelery before performing any maintenance task.
Unapproved or inaccurately performed maintenance actions can result in serious
personal injury and material damage.
• Only perform maintenance actions stated by the software.
• Follow closely the steps contained in the individual instructions.
• For the maintenance actions, only use parts or reagents mentioned in this instruction.
• Tests and maintenance actions specified by the manufacturer must be performed to
ensure the safe operation of the system and the proper functioning of the system.
• All service and maintenance actions which are not described in this instruction must be
performed by qualified and authorized service technicians.
• Any changes made to the instrument that are not authorized by the manufacturer will
lead to the loss of guarantee.
Handling of Decontamination Products
• Pay attention in managing the decontamination products, because they may be
harmful. Read the instructions of the decontamination products before use.
• Do not mix sodium hypochlorite solution (e.g. bleach) or different chlorine cleaning
solution (see chapter 7.3) with alcohol or any other flammable.
7. Maintenance
Page 7-2 LIAISON
®
XS - Instruction for use Rev. H
Danger of Electrocution or Mechanical Injury during Required Maintenance Works
on the Voltage-Carrying System
If the system cannot be separated from the main supply during required maintenance
works, additional precautions must be taken to avoid serious injury with lethal
consequences due to electrocution or injury by the system (e.g. contusion, cuts etc.).
• Only switch on the system if this is explicitly required.
• Only explicitly described protective covers may be opened.
• Perform the maintenance works with highest caution.
• Never touch electrical connecting contacts.
• Please note that mechanical components (e.g. pipettor) can move unexpectedly.
Disposal
The instrument, the packaging material, and all parts that have been replaced must be
disposed according to the applicable local and national provisions, legislation and
laboratory procedures.
Cleaning, Disinfection or Decontamination
Observe the following aspects during cleaning, disinfection or decontamination because
breakdowns or damages can be the result.
• Liquid cleaning, disinfection or decontamination solutions may only be used with a
moistened cleaning tissue. They may not be poured into or sprayed into the system.
• Only cleaning, disinfection or decontamination solutions and procedures stated by the
software are approved.
• Cleaning, disinfection or decontamination solutions must not come into contact with
bearings and guides, as otherwise the greasy film may dissolve!
• Cleaning, disinfection or decontamination solutions must not be used in the vicinity of
circuit boards and light barriers!
Unsuitable Sterilization Method
Containers and components for liquids or waste are seriously damaged by autoclaving.
• Disinfect or decontaminate the containers and components with a suitable disinfection
or decontamination method.
• Comply with procedures stated by the software.
• Disposable materials must be incinerated.
• Liquid waste must be decontaminated with a chemical use sodium hypochlorite solution
with 0.1 % active chlorine (e.g. dilution 1:50 of a solution at 5 % active chlorine) for at
least half an hour.
Handling/Cleaning of Optic Surfaces
Optic surfaces (e.g. scanners, lenses, sensors) must be free of dust and grease.
• Do not touch any optic surfaces.
• Only clean the optic surfaces with a softy and lint-free cloth.
• Do not use any aggressive detergents (e.g. acetone).
7. Maintenance
LIAISON
®
XS - Instruction for use Rev. H Page 7-3
7.2 Scheduled Maintenance Tasks
LIAISON
®
XS system informs user about the need to perform a maintenance task
(see chapter 6.11). Please perform the scheduled maintenance tasks as requested.
Please consult the following sections for procedures.
Local service support may perform or be required to perform maintenance tasks that may
be necessary for specific purposes (e.g. troubleshooting).
Local service support is allowed to perform preventive maintenance according to
DiaSorin Italia S.p.A. procedures.
7.3 Preparation of the Cleaning Solution in the cleaning
tank
The execution of the Short and Long Term maintenance procedures foresees the use of a
cleaning solution that contains a final concentration of 0.1-0.2 % of active chlorine
(e.g.using a dilution 1:50 of a solution at 5-9 % of active chlorine). In the following paragraph
the preparation of the cleaning solution using one example of cleaning agent is described.
7.3.1 Cleaning Solution using sodium hypochlorite solution
Follow the instruction to prepare the Cleaning Solution at 0.1-0.2 % of active chlorine using
sodium hypochlorite solution at 5-9 % of active chlorine.
1. Fill the Cleaning Tank with 1470 mL of distilled water;
2. Add 30 mL of a sodium hypochlorite solution (e.g. bleach) with a 5-9 % content
of active chlorine. In case the available sodium hypochlorite should have a
different titer, please adjust the dilution accordingly;
3. Shake the tank gently to remove residuals.
Touch Screen Cleaning
Improper cleaning could damage the touch screen surface.
• Use soft clothes with neutral detergent or with ethanol to clean the touch screen.
• Do not use any chemical solvent, acidic or alkaline solution.
• Do not allow liquid to soak into the joint of film and glass as it may result in peeling or
malfunctioning.
Organic Solvents
Reagent containers and hoses (water and waste) can be seriously damaged by or
become unusable because of organic solvents.
Never use organic solvents.
Before chlorine cleaning agents are handled, the package information and material safety
data sheet are to be read thoroughly and followed by the user.
In case commercial sodium hypochlorite solutions are used (e.g. bleach), avoid
formulations featuring any fragrance, surfactant, other oxidizer or additive.
7. Maintenance
Page 7-4 LIAISON
®
XS - Instruction for use Rev. H
7.4 Short and Long Term Maintenance
7.5 Clean the wash buffer and the system liquid tanks
Tanks containing system liquid and wash buffer solution shall be cleaned during the
execution of the Long Term Maintenance procedure, as indicate by a dedicate pop-up that
appears during the execution of the task.
Figure 7–1: pop-up of the instruments tanks cleaning
Before starting each Short or Long Term Maintenance tasks, 1.5 L of Cleaning Solution
shall be prepared according to chapter 7.3.
In order to guarantee the correct cleaning of the instrument, ensure that the cleaning tank
is connected to the proper line as indicated in the maintenance task.
See chapter 5.4.4 and 5.4.5 for the load/unload procedure of the tanks.
Short Term
maintenance
7.4.1 Procedure
1. Ensure that the instrument is not in “running” or “maintenance” status before
starting the Short Term maintenance;
2. Click on the Maintenance main category and select the Short Term
Maintenance Task;
3. Tap on the “Perform” Button to start the Short Term Maintenance;
4. Follow the instructions described in the maintenance task.
Long Term
maintenance
7.4.2 Procedure
1. Ensure that the instrument is not in “running” or “maintenance” status before
starting the Long Term maintenance;
2. Click on the Maintenance main category and select the Long Term
Maintenance Task;
3. Tap on the “Perform” Button to start the Long Term Maintenance;
4. Follow the instructions described in the maintenance task.
7. Maintenance
LIAISON
®
XS - Instruction for use Rev. H Page 7-5
The cleaning of tanks shall be performed with 1.5 Liter of cleaning solution at 0.1-0.2 % of
active chlorine. The following paragraph reports the instructions to clean the system liquid
and wash buffer tanks
7.5.1 Procedure
11. If all the required cleaning procedures have been completed, press the “Accept”
button in the pop-up, otherwise continue with the execution of the other cleaning
procedures.
Tanks removal 1. Unload the wash buffer and the system liquid tanks (see chapters 5.4.4 and
5.4.5);
2. Dispose of all residual liquid from the wash buffer and system liquid tanks;
Tanks cleaning 3. Prepare 1.5 Liter of cleaning solution at 0.1-0.2 % of active chlorine in the
system liquid tank (e.g. fill the system liquid tank with 1470 mL of distilled water,
then add 30 mL of a sodium hypochlorite solution with a 5-9 % content of active
chlorine);
4. Prepare 1.5 Liter of cleaning solution at 0.1-0.2 % of active chlorine in the wash
buffer tank (e.g. fill the wash buffer tank with 1470 mL of distilled water, then add
30 mL of a sodium hypochlorite solution with a 5-9 % content of active chlorine);
5. Ensure the complete homogenization of the solution;
6. Gently shake each tank, avoiding spilling and limiting the formation of foam.
7. Carefully empty each tank and rinse it thoroughly with distilled water (to ensure
adequate rinsing, it is recommended to fill each tank at least at half volume).
Water to be used has to be defined according to CLSI guidelines for laboratory
water (“Instrument Feed Water” type);
8. Repeat operation at previous point at least two more times for each tank;
Tanks insertion 9. Fill the system liquid tank with the system liquid, plug the cap and load it into the
system according to chapter 5.4.4;
10. Fill the wash buffer tank with the dedicated solution, plug the cap and load it into
the system according to chapter 5.4.5.
For the preparation of the wash buffer solution, refer to the instructions for use.
For the preparation of the system liquid solution, refer to the instructions for use.
7. Maintenance
Page 7-6 LIAISON
®
XS - Instruction for use Rev. H
7.6 Manual Cleaning of the instrument
Some parts of the instrument shall be cleaned during the execution of the Short and Long
Term Maintenance procedures, as indicated by a dedicated pop-up that appears during the
execution of the task.
Figure 7–2: Short Term Maintenance - Manual Cleaning pop-up
Figure 7–3: Long Term Maintenance - Manual Cleaning pop-up
The following procedure shall be executed to complete the cleaning:
1. Instrument automatically shuts down all modules;
2. Wipe the external side of the covers (top covers, side covers, front covers) with a
tissue saturated with an alcoholic/disinfectant solution (to be executed in the
Long Term Maintenance procedure only);
3. Open the sample area flap and extract the available sample racks;
4. Once sample tubes have been removed, wipe each rack with a tissue saturated
with an alcoholic/disinfectant solution;
5. Wipe the surfaces of the sample module with a tissue saturated with an
alcoholic/disinfectant solution;
6. Push the sample racks back into the sample area and close the flap;
7. Open the reagent area flap and extract the ancillary plate;
8. Wipe the surfaces of the ancillary plate with a tissue soaked with an alcoholic/
disinfectant solution;
9. Wipe the accessible surfaces of the reagent area with a tissue saturated with an
alcoholic/disinfectant solution;
7. Maintenance
LIAISON
®
XS - Instruction for use Rev. H Page 7-7
10. Push the ancillary plate back into the reagent area and close the flap;
11. Open the starter reagent area flap;
12. Remove the starter bottles;
13. Wipe the surfaces of the starter reagent area with a tissue saturated with an
alcoholic/disinfectant solution;
14. Insert starter bottles back into the starter reagent area;
15. Remove the Liquid Waste tank from the Liquid Waste Basin;
16. Wipe the surfaces of the Liquid Waste Basin with a tissue saturated with an
alcoholic/disinfectant solution;
17. Insert the Liquid Waste tank on the Liquid Waste Basin;
18. Remove the EASY Waste from the Solid Waste Bin according to chapter 5.4.7;
19. Wipe the surfaces of the Solid Waste Drawer with a tissue saturated with an
alcoholic/disinfectant solution;
20. Insert the EASY Waste Box on the Solid Waste Bin according to chapter 5.4.7;
21. Open the top covers and wipe the right arm needle and the pipettor wash station
(upper rim) with a tissue soaked with the cleaning solution prepared according to
chapter 7.3;
22. Wipe the right arm needle and the pipettor wash station (upper rim) with a tissue
soaked with DI water;
23. Wipe the right arm needle and the Pipettor wash station (upper rim) with a dry
tissue;
24. If all the required cleaning procedures have been completed, close the top
covers, press the “accept” button and follow the instruction described in the
maintenance task, otherwise continue with the execution of the other cleaning
procedures.
7.7 LIAISON
®
EASY Cleaning Tool
The LIAISON
®
EASY Cleaning Tool (part number 310996) is a DiaSorin Italia S.p.A.
product, useful to improve routine maintenance of the LIAISON
®
XS analyzer. A sodium
hypochlorite solution cleanses the washer needles and tubes and the measurement
chamber. They are rinsed afterwards by the mean of a wash solution.
The LIAISON
®
EASY Cleaning Tool is to be performed once a week after the completion
of a daily routine, as the last operation of the day (prior to possible maintenance sessions)
or as the first operation of the next day, before the daily routine.
Use a new tissue for each part; dispose of used tissues as biological hazardous materials.
Refer to the instruction for use of the LIAISON
®
EASY Cleaning Tool before its use.
Maintenance with LIAISON
®
EASY Cleaning Tool does not replace the short and long
maintenance of the LIAISON
®
XS analyzer.
7. Maintenance
Page 7-8 LIAISON
®
XS - Instruction for use Rev. H
7.8 Automated actions performed by the system
After four hours of rest the system switches from Ready to Standby and set the following
resources to “Not Primed”:
• System Liquid
• Wash Buffer
• Starters
The system automatically performs the following actions at specified times, in order to
improve the system performance:
• initialization
• resume
• automated back-up and clean-up of archived results from the Archived menu.
These times are configurable (see chapter 6.9.5).
While the system is in Standby and Ready it performs an automatic pipettor rinsing with
System Liquid.
Presence of a connected and above red phase System Liquid tank, as well as connected
and below red phase wastes, is necessary to support the periodic pipettor rinsing.
It is recommended to promptly reconnect:
• the System Liquid tank upon refilling
• Liquid and Solid wastes upon emptying.
It is not possible to modify the Cuvettes/Tips assignment in case the system status is
“Maintenance”, including during the automatic pipettor rinsing execution.
Systems working overnight
In case the system works overnight without significant interruptions, the automated back-
up and the initialization are performed as soon as the system switches to “Ready” or
“Standby”.
The resume is not performed if at the due time the system is not in “Standby” status.
8. Troubleshooting and error messages
LIAISON
®
XS - Instruction for use Rev. H Page 8-1
8 Troubleshooting and error
messages
This Chapter describes error messages or information messages and gives instruction on
error recovery.
8.1 SPOLVRightArm
Device ID: 0xFD
8.1.1 Sub assemblies
Table 8–1: Sub assemblies, SPOLVRightArm
If the error reoccurs, please call service.
The system may automatically reschedule replicates failed for a reason that could be
recovered without user intervention.
Meaning
Parameters {...} Some error messages show details about the error. With this
information, the cause or the affected sample may be found. In the
error list these details will be shown as parameters (e.g. {SID}).
Effect Depending on the fault category, the error will be noted differently.
In the error list the notification will be shown in the column effect.
• L: adds an entry to the event log
• M: shows a message
• S: sounds an acoustic signal
ID (dec) ID (hex) Name
17 0x11 General
18 0x12 SctlCU
8. Troubleshooting and error messages
Page 8-2 LIAISON
®
XS - Instruction for use Rev. H
8.1.2 Message list
Message Description Action Effect Event ID
An internal error
occurred
Affected module: Right
Pipettor
Electronics
• If the problem persists call
Service
L M S 253.017.00004
A communication error
occurred
- Electronics
• Initialize the system
• If the problem persists,
Switch-off, restart and
initialize the system
• If the problem persists call
Service
L M S 253.017.00005
Syringe motor overload Affected module: Right
Pipettor
Electronics
• Initialize the system
• If the problem persists call
Service
Mechanics
L M S 253.017.00010
Syringe motor overload Affected module: Right
Pipettor
Electronics
• Initialize the system
• If the problem persists call
Service
Mechanics
L M S 253.018.00010
A communication error
occurred
Affected module: Right
Pipettor
Electronics
• Initialize the system
• If the problem persists,
Switch-off, restart and
initialize the system
• If the problem persists call
Service
L M S 253.017.00033
Initialization of syringe
failed
Affected module: Right
Pipettor
Electronics
• Initialize the system
• If the problem persists,
Switch-off, restart and
initialize the system
• If the problem persists call
Service
Mechanics
L M S 253.017.00035
Syringe motor overload Affected module: Right
Pipettor
Electronics
• If the problem persists call
Service
Mechanics
L M S 253.017.00037
Target position not
reached by syringe
Affected module: Right
Pipettor
Electronics
• Initialize the system
• If the problem persists call
Service
Mechanics
L M S 253.017.00048
8. Troubleshooting and error messages
LIAISON
®
XS - Instruction for use Rev. H Page 8-3
Table 8–2: Message list, SPOLVRightArm
8.2 SingleSledgeZ
Device ID: 0xFD
8.2.1 Sub assemblies
Table 8–3: Sub assemblies, SingleSledgeZ
8.2.2 Message list
Initialization of syringe
failed
Affected module: Right
Pipettor
Electronics
• Initialize the system
• If the problem persists,
Switch-off, restart and
initialize the system
• If the problem persists call
Service
L M S 253.017.00052
Syringe overpressure Affected module: Right
Pipettor
Calibration
• Initialize the system
• If the problem persists call
Service
Consumable
L M S 253.017.00053
Message Description Action Effect Event ID
ID (dec) ID (hex) Name
12 0x0C General
13 0x0D ZDrive1
255 0xFF ZDrive2
Message Description Action Effect Event ID
An internal error
occurred
Affected module: Right
Sledge
Electronics
• If the problem persists call
Service
L M S 253.012.00004
A communication error
occurred
Affected module: Right
Sledge
Electronics
• Initialize the system
• If the problem persists,
Switch-off, restart and
initialize the system
• If the problem persists call
Service
L M S 253.012.00005
8. Troubleshooting and error messages
Page 8-4 LIAISON
®
XS - Instruction for use Rev. H
Z motor overload Affected module: Right
Sledge
Mechanics
• Initialize the system
• If the problem persists call
Service
Electronics
L M S 253.013.00037
Z motor overload Affected module: Right
Sledge
Mechanics
• Initialize the system
• If the problem persists call
Service
Electronics
L M S 253.255.00037
Target position not
reached by Z motor
Affected module: Right
Sledge
Electronics
• Initialize the system
• If the problem persists call
Service
Mechanics
L M S 253.013.00048
Target position not
reached by Z motor
Affected module: Right
Sledge
Electronics
• Initialize the system
• If the problem persists call
Service
Mechanics
L M S 253.255.00048
Initialization of Z motor
failed
Affected module: Right
Sledge
Mechanics
• Initialize the system
• If the problem persists,
Switch-off, restart and
initialize the system
• If the problem persists call
Service
Electronics
L M S 253.013.00050
Initialization of Z motor
failed
Affected module: Right
Sledge
Mechanics
• Initialize the system
• If the problem persists,
Switch-off, restart and
initialize the system
• If the problem persists call
Service
Electronics
L M S 253.255.00050
Initialization of Z motor
failed
Affected module: Right
Sledge
Mechanics
• Initialize the system
• If the problem persists,
Switch-off, restart and
initialize the system
• If the problem persists call
Service
Electronics
L M S 253.013.00051
Message Description Action Effect Event ID
8. Troubleshooting and error messages
LIAISON
®
XS - Instruction for use Rev. H Page 8-5
Table 8–4: Message list, SingleSledgeZ
8.3 SingleSledgeY
Device ID: 0xFD
8.3.1 Sub assemblies
Table 8–5: Sub assemblies, SingleSledgeY
8.3.2 Message list
Initialization of Z motor
failed
Affected module: Right
Sledge
Mechanics
• Initialize the system
• If the problem persists,
Switch-off, restart and
initialize the system
• If the problem persists call
Service
Electronics
L M S 253.255.00051
Message Description Action Effect Event ID
ID (dec) ID (hex) Name
7 0x07 General
8 0x08 Y_Drive
Message Description Action Effect Event ID
An internal error
occurred
Affected module: Right
Sledge
Electronics
• If the problem persists call
Service
L M S 253.007.00004
A communication error
occurred
Affected module: Right
Sledge
Electronics
• Initialize the system
• If the problem persists,
Switch-off, restart and
initialize the system
• If the problem persists call
Service
L M S 253.007.00005
Target position reached
after retry.
Only information Electronics
-
Mechanics
L 253.008.00009
Target position not
reached by Y motor
Affected module: Right
Sledge
Electronics
• Initialize the system
• If the problem persists call
Service
Mechanics
L M S 253.008.00010
8. Troubleshooting and error messages
Page 8-6 LIAISON
®
XS - Instruction for use Rev. H
Table 8–6: Message list, SingleSledgeY
A movement problem
has been detected
Affected module: Right
Sledge
Mechanics
• Initialize the system
• If the problem persists call
Service
Electronics
L M S 253.007.00023
A movement problem
has been detected
Affected module: Right
Sledge
Mechanics
• Initialize the system
• If the problem persists call
Service
Electronics
L M S 253.008.00023
Initialization of Y motor
failed
Affected module: Right
Sledge
Mechanics
• Initialize the system
• If the problem persists,
Switch-off, restart and
initialize the system
• If the problem persists call
Service
Electronics
L M S 253.008.00050
Initialization of Y motor
failed
Affected module: Right
Sledge
Mechanics
• Initialize the system
• If the problem persists,
Switch-off, restart and
initialize the system
• If the problem persists call
Service
Electronics
L M S 253.008.00051
Message Description Action Effect Event ID
8. Troubleshooting and error messages
LIAISON
®
XS - Instruction for use Rev. H Page 8-7
8.4 Pipettor
Device ID: 0xFD
8.4.1 Sub assemblies
Table 8–7: Sub assemblies, Pipettor
ID (dec) ID (hex) Name
0 0x00 General
3 0x03 LeftYMotor
4 0x04 RightYMotor
10x01LeftArm
2 0x02 RightArm
50x05LeftXMain
6 0x06 LeftXMotor
7 0x07 RightXMain
8 0x08 RightXMotor
90x09LeftZMain
10 0x0A LeftZMotor1
11 0x0B LeftZMotor2
12 0x0C RightZMain
13 0x0D RightZMotor1
14 0x0E LeftZspipMain
15 0x0F LeftZspipSctl
16 0x10 LeftZspipHead
17 0x11 RightSpolvMain
18 0x12 RightSpolvSctl
19 0x13 RightSpolvHead
20 0x14 LeftGripper
21 0x15 DrainPump
8. Troubleshooting and error messages
Page 8-8 LIAISON
®
XS - Instruction for use Rev. H
8.4.2 Message list
Message Description Action Effect Event ID
An internal error
occurred
Affected module:
Pipettor
Electronics
• If the problem persists call
Service
L M S 253.000.00004
A communication error
occurred
Affected module:
Pipettor
Electronics
• Initialize the system
• If the problem persists,
Switch-off, restart and
initialize the system
• If the problem persists call
Service
L M S 253.000.00005
Target position reached
after retry.
Only information Electronics
-
Mechanics
L 253.003.00009
Target position reached
after retry.
Only information Electronics
-
Mechanics
L 253.004.00009
Target position not
reached by Y motor
Affected module:
Left Pipettor
Electronics
• Initialize the system
• If the problem persists call
Service
Mechanics
L M S 253.003.00010
Target position not
reached by Y motor
Affected module:
Right Pipettor
Electronics
• Initialize the system
• If the problem persists call
Service
Mechanics
L M S 253.004.00010
A movement problem
has been detected
Affected module:
Left Pipettor
Mechanics
• Initialize the system
• If the problem persists call
Service
Electronics
L M S 253.003.00023
A movement problem
has been detected
Affected module:
Right Pipettor
Mechanics
• Initialize the system
• If the problem persists call
Service
Electronics
L M S 253.004.00023
Initialization of Y motor
failed
Affected module:
Left Pipettor
Mechanics
• Initialize the system
• If the problem persists,
Switch-off, restart and
initialize the system
• If the problem persists call
Service
Electronics
L M S 253.003.00034
8. Troubleshooting and error messages
LIAISON
®
XS - Instruction for use Rev. H Page 8-9
Initialization of Y motor
failed
Affected module:
Right Pipettor
Mechanics
• Initialize the system
• If the problem persists,
Switch-off, restart and
initialize the system
• If the problem persists call
Service
Electronics
L M S 253.004.00034
Initialization of Y motor
failed
Affected module:
Left Pipettor
Mechanics
• Initialize the system
• If the problem persists,
Switch-off, restart and
initialize the system
• If the problem persists call
Service
Electronics
L M S 253.003.00035
Initialization of Y motor
failed
Affected module:
Right Pipettor
Mechanics
• Initialize the system
• If the problem persists,
Switch-off, restart and
initialize the system
• If the problem persists call
Service
Electronics
L M S 253.004.00035
The pipettor is missing
target coordinates.
Affected module:
Left Pipettor
Configuration
• Call Service
L M S 253.001.00048
The pipettor is missing
target coordinates.
Affected module:
Right Pipettor
Configuration
• Call Service
L M S 253.002.00048
Test of the Liquid Level
Detection sensor
system has failed.
Affected module:
Left Pipettor
Electronics
• Call Service
L M S 253.001.00052
Test of the Liquid Level
Detection sensor
system has failed.
Affected module:
Right Pipettor
Electronics
• Call Service
L M S 253.002.00052
Pipettor has lost a
disposable tip.
Affected module:
Left Pipettor
Mechanics
• Call Service
Configuration
L M S 253.001.00055
Gripper has lost a
cuvette
Affected module:
Left Pipettor
Mechanics
• Call Service
Configuration
L M S 253.001.00059
The pipettor wash
pump is not connected
or broken.
Affected module:
Right Pipettor
Electronics
•
Call Service
L M S 253.002.00061
Message Description Action Effect Event ID
8. Troubleshooting and error messages
Page 8-10 LIAISON
®
XS - Instruction for use Rev. H
Table 8–8: Message list, Pipettor
Disposable tip eject
failed
Mechanics
• Empty the solid waste box
• Initialize the system
• If the problem persists call
Service
L M S 253.001.00062
Undefined OLV dead
volume reference value
Affected module:
Right Pipettor
Call Service L 253.002.00096
An internal error
occurred
Affected module:
Pipettor
Calibration
• If the problem persists call
Service
Electronics
L M S 253.000.00176
An internal error
occurred
Affected module:
Pipettor
Configuration
• If the problem persists call
Service
Electronics
L M S 253.000.00180
Message Description Action Effect Event ID
8. Troubleshooting and error messages
LIAISON
®
XS - Instruction for use Rev. H Page 8-11
8.5 LWP
Device ID: 0xFD
8.5.1 Sub assemblies
Table 8–9: Sub assemblies, LWP
8.5.2 Message list
Table 8–10: Message list, LWP
ID (dec) ID (hex) Name
21 0x15 General
Message Description Action Effect Event ID
An internal error
occurred
Affected module: LWP Electronics
• If the problem persists call
Service
L M S 253.021.00004
A communication error
occurred
Affected module: LWP Electronics
• Initialize the system
• If the problem persists,
Switch-off, restart and
initialize the system
• If the problem persists call
Service
L M S 253.021.00005
Motor overload Affected module: LWP Electronics
• Initialize the system
• If the problem persists call
Service
Mechanics
L M S 253.021.00008
Target position reached
after retry.
Only information Electronics
-
Mechanics
L 253.021.00009
Target position not
reached by pump
Affected module: LWP Electronics
• Initialize the system
• If the problem persists call
Service
Mechanics
L M S 253.021.00010
8. Troubleshooting and error messages
Page 8-12 LIAISON
®
XS - Instruction for use Rev. H
8.6 Gripper
Device ID: 0xFD
8.6.1 Sub assemblies
Table 8–11: Sub assemblies, Gripper
8.6.2 Message list
Table 8–12: Message list, Gripper
ID (dec) ID (hex) Name
20 0x14 General
Message Description Action Effect Event ID
An internal error
occurred
Affected module:
Gripper
Electronics
• If the problem persists call
Service
L M S 253.020.00004
A communication error
occurred
Affected module:
Gripper
Electronics
• Initialize the system
• If the problem persists,
Switch-off, restart and
initialize the system
• If the problem persists call
Service
L M S 253.020.00005
Motor overload Affected module:
Gripper
Electronics
• Initialize the system
• If the problem persists call
Service
Mechanics
L M S 253.020.00008
Target position reached
after retry.
Only information Electronics
-
Mechanics
L 253.020.00009
Target position not
reached by gripper
Affected module:
Gripper
Electronics
• Initialize the system
• If the problem persists call
Service
Mechanics
L M S 253.020.00010
An internal error
occurred
Affected module:
Gripper
Calibration
• If the problem persists call
Service
Electronics
L M S 253.020.00176
An internal error
occurred
Affected module:
Gripper
Configuration
• If the problem persists call
Service
Electronics
L M S 253.020.00180
8. Troubleshooting and error messages
LIAISON
®
XS - Instruction for use Rev. H Page 8-13
8.7 DualSledgeZ
Device ID: 0xFD
8.7.1 Sub assemblies
Table 8–13: Sub assemblies, DualSledgeZ
8.7.2 Message list
ID (dec) ID (hex) Name
9 0x09 General
10 0x0A ZDrive1
11 0x0B ZDrive2
Message Description Action Effect Event ID
An internal error
occurred
Affected module: Left
Sledge
Electronics
• If the problem persists call
Service
L M S 253.009.00004
A communication error
occurred
Affected module: Left
Sledge
Electronics
• Initialize the system
• If the problem persists,
Switch-off, restart and
initialize the system
• If the problem persists call
Service
L M S 253.009.00005
Z motor overload Affected module: Left
Pipettor
Mechanics
• Call Service
Electronics
L M S 253.010.00037
Z motor overload Affected module:
Gripper
Mechanics
• Call Service
Electronics
L M S 253.011.00037
Target position not
reached by Z motor
Affected module: Left
Pipettor
Electronics
• Initialize the system
• If the problem persists call
Service
Mechanics
L M S 253.010.00048
Target position not
reached by Z motor
Affected module:
Gripper
Electronics
• Initialize the system
• If the problem persists call
Service
Mechanics
L M S 253.011.00048
8. Troubleshooting and error messages
Page 8-14 LIAISON
®
XS - Instruction for use Rev. H
Table 8–14: Message list, DualSledgeZ
8.8 DualSledgeY
Device ID: 0xFD
8.8.1 Sub assemblies
Table 8–15: Sub assemblies, DualSledgeY
Initialization of Z motor
failed
Affected module: Left
Pipettor
Mechanics
• Initialize the system
• If the problem persists,
Switch-off, restart and
initialize the system
• If the problem persists call
Service
Electronics
L M S 253.010.00050
Initialization of Z motor
failed
Affected module:
Gripper
Mechanics
• Initialize the system
• If the problem persists,
Switch-off, restart and
initialize the system
• If the problem persists call
Service
Electronics
L M S 253.011.00050
Initialization of Z motor
failed
Affected module: Left
Pipettor
Mechanics
• Initialize the system
• If the problem persists,
Switch-off, restart and
initialize the system
• If the problem persists call
Service
Electronics
L M S 253.010.00051
Initialization of Z motor
failed
Affected module:
Gripper
Mechanics
• Initialize the system
• If the problem persists,
Switch-off, restart and
initialize the system
• If the problem persists call
Service
Electronics
L M S 253.011.00051
Message Description Action Effect Event ID
ID (dec) ID (hex) Name
5 0x05 General
6 0x06 Y_Drive
8. Troubleshooting and error messages
LIAISON
®
XS - Instruction for use Rev. H Page 8-15
8.8.2 Message list
Table 8–16: Message list, DualSledgeY
Message Description Action Effect Event ID
An internal error
occurred
Affected module:
Left Sledge
Electronics
• If the problem persists call
Service
L M S 253.005.00004
A communication error
occurred
Affected module:
Left Sledge
Electronics
• Initialize the system
• If the problem persists,
Switch-off, restart and
initialize the system
• If the problem persists call
Service
L M S 253.005.00005
Target position reached
after retry.
Only information Electronics
-
Mechanics
L 253.006.00009
Target position not
reached by X motor
Affected module:
Left Sledge
Electronics
• Initialize the system
• If the problem persists call
Service
Mechanics
L M S 253.006.00010
A movement problem
has been detected
Affected module:
Left Sledge
Mechanics
• Initialize the system
• If the problem persists call
Service
Electronics
L M S 253.005.00023
A movement problem
has been detected
Affected module:
Left Sledge
Mechanics
• Initialize the system
• If the problem persists call
Service
Electronics
L M S 253.006.00023
Initialization of Y motor
failed
Affected module:
Left Sledge
Mechanics
• Initialize the system
• If the problem persists,
Switch-off, restart and
initialize the system
• If the problem persists call
Service
Electronics
L M S 253.006.00050
Initialization of Y motor
failed
Affected module:
Left Sledge
Mechanics
• Initialize the system
• If the problem persists,
Switch-off, restart and
initialize the system
• If the problem persists call
Service
Electronics
L M S 253.006.00051
8. Troubleshooting and error messages
Page 8-16 LIAISON
®
XS - Instruction for use Rev. H
8.9 AirPipettorLeftArm
Device ID: 0xFD
8.9.1 Sub assemblies
Table 8–17: Sub assemblies, AirPipettorLeftArm
8.9.2 Message list
ID (dec) ID (hex) Name
14 0x0E General
15 0x0F SctlCU
Message Description Action Effect Event ID
An internal error
occurred
Affected module:
Left Pipettor
Electronics
• If the problem persists call
Service
L M S 253.014.00004
A communication error
occurred
- Electronics
• Initialize the system
• If the problem persists,
Switch-off, restart and
initialize the system
• If the problem persists call
Service
L M S 253.014.00005
Syringe motor overload Affected module:
Left Pipettor
Electronics
• Initialize the system
• If the problem persists call
Service
Mechanics
L M S 253.014.00010
Syringe motor overload Affected module:
Left Pipettor
Electronics
• Initialize the system
• If the problem persists call
Service
Mechanics
L M S 253.015.00010
A communication error
occurred
Affected module:
Left Pipettor
Electronics
• Initialize the system
• If the problem persists,
Switch-off, restart and
initialize the system
• If the problem persists call
Service
L M S 253.014.00033
8. Troubleshooting and error messages
LIAISON
®
XS - Instruction for use Rev. H Page 8-17
Table 8–18: Message list, AirPipettorLeftArm
Initialization of syringe
failed
Affected module:
Left Pipettor
Electronics
• Initialize the system
• If the problem persists,
Switch-off, restart and
initialize the system
• If the problem persists call
Service
Mechanics
L M S 253.014.00035
Syringe motor overload Affected module:
Left Pipettor
Electronics
• If the problem persists call
Service
Mechanics
L M S 253.014.00037
Target position not
reached by syringe
Affected module:
Left Pipettor
Electronics
• Initialize the system
• If the problem persists call
Service
Mechanics
L M S 253.014.00048
Initialization of syringe
failed
Affected module:
Left Pipettor
Electronics
• Initialize the system
• If the problem persists,
Switch-off, restart and
initialize the system
• If the problem persists call
Service
L M S 253.014.00052
Syringe overpressure Affected module:
Left Pipettor
Calibration
• Initialize the system
• If the problem persists call
Service
Consumable
L M S 253.014.00053
Message Description Action Effect Event ID
8. Troubleshooting and error messages
Page 8-18 LIAISON
®
XS - Instruction for use Rev. H
8.10 ComGenDriver
Device ID: 0xEF
8.10.1 Sub assemblies
Table 8–19: Sub assemblies, ComGenDriver
8.10.2 Message list
Table 8–20: Message list, ComGenDriver
ID (dec) ID (hex) Name
10x01LeftArm
2 0x02 RightArm
Message Description Action Effect Event ID
Tip eject failed Affected module:
Left Pipettor
ProcessControl
• Initialize the system
• If the problem persists call
Service
L M S 239.001.00147
New cuvette pickup
failed
- InstrumentHandling
• Check consumable states
• Perform an initialization
• If the problem persists call
Service
L M S 239.001.00157
OLV sensor calibration
failed
Affected module:
Right Pipettor
ProcessControl
• Initialize the system and
perform the resume
• If the problem persists call
Service
L M S 239.002.00149
OLV dead volume
verification failed
Affected module:
Right Pipettor
ProcessControl
• Initialize the system and
perform the resume
• If the problem persists call
Service
L M S 239.002.00150
DiTi pickup failed
multiple times
ProcessControl L M S 239.001.00174
Pickup of new cuvette
failed multiple times
ProcessControl L M 239.001.00175
8. Troubleshooting and error messages
LIAISON
®
XS - Instruction for use Rev. H Page 8-19
8.11 FrontCoverDriver
Device ID: 0xE9
8.11.1 Sub assemblies
Table 8–21: Sub assemblies, FrontCoverDriver
8.11.2 Message list
Table 8–22: Message list, FrontCoverDriver
ID (dec) ID (hex) Name
0 0x00 General
Message Description Action Effect Event ID
Front Cover is
{FlapDrawerState}
- ProcessControl L 233.000.00048
Consumable drawer is
{FlapDrawerState}.
Only information ProcessControl L 233.000.00049
Starter reagent flap is
{FlapDrawerState}.
Only information ProcessControl L 233.000.00050
Reagent bay flap is
{FlapDrawerState}.
Only information ProcessControl L 233.000.00051
Sample bay flap is
{FlapDrawerState}.
Only information ProcessControl L 233.000.00052
Solid waste drawer is
{FlapDrawerState}.
Only information ProcessControl L 233.000.00053
Reagent bay flap is
open for a too long
time.
- ProcessControl
• Please, close the reagent bay
flap
L M S 233.000.00054
8. Troubleshooting and error messages
Page 8-20 LIAISON
®
XS - Instruction for use Rev. H
8.12 LiquidSupportDriver
Device ID: 0xE8
8.12.1 Sub assemblies
Table 8–23: Sub assemblies, LiquidSupportDriver
8.12.2 Message list
Table 8–24: Message list, LiquidSupportDriver
ID (dec) ID (hex) Name
3 0x03 HeatTube1
4 0x04 HeatTube2
Message Description Action Effect Event ID
Starter 1 (injection)
temperature is out of
range
The system is still
initializing or resuming;
The system was shut
down for a long time;
Hardware defect
• Wait for the temperature to be
back in range
• If the problem persists call
Service
L S 232.003.00161
Starter 2 (injection)
temperature is out of
range
The system is still
initializing or resuming;
The system was shut
down for a long time;
Hardware defect
• Wait for the temperature to be
back in range
• If the problem persists call
Service
L S 232.004.00161
Starter 1 (injection)
temperature is back in
range
Only information - L 232.003.00162
Starter 2 (injection)
temperature is back in
range
Only information - L 232.004.00162
8. Troubleshooting and error messages
LIAISON
®
XS - Instruction for use Rev. H Page 8-21
8.13 ReagentSampleBayDriver
Device ID: 0xE6
8.13.1 Sub assemblies
Table 8–25: Sub assemblies, ReagentSampleBayDriver
8.13.2 Message list
Table 8–26: Message list, ReagentSampleBayDriver
ID (dec) ID (hex) Name
0 0x00 General
1 0x01 Reagent
Message Description Action Effect Event ID
Reagent bay
temperature is out of
range for too long time.
Affected module:
Reagent Bay
Environmental
• Wait for the temperature to be
back in range
• If the problem persists call
Service
Configuration
L M S 230.000.00037
Stirrer rotation
frequency too low
- Electronics
• If the problem persists call
Service
Mechanics
L M S 230.001.00052
8. Troubleshooting and error messages
Page 8-22 LIAISON
®
XS - Instruction for use Rev. H
8.14 MeasurementDriver
Device ID: 0xE5
8.14.1 Sub assemblies
Table 8–27: Sub assemblies, MeasurementDriver
8.14.2 Message list
Table 8–28: Message list, MeasurementDriver
ID (dec) ID (hex) Name
0 0x00 General
1 0x01 BubbleSensor
Message Description Action Effect Event ID
Dark count events
occured
Affected module:
Reader
ProcessControl
• Call Service
Electronics
Mechanics
L M S 229.000.00085
Aspiration failed for 3
consecutive
measurements at
reader port
Affected module:
Reader
ProcessControl
• Perform the Initialization and
then the Bubble Sensor
calibration
• If the problem persists call
Service
L M S 229.001.00145
8. Troubleshooting and error messages
LIAISON
®
XS - Instruction for use Rev. H Page 8-23
8.15 WasherDriver
Device ID: 0xE4
8.15.1 Sub assemblies
Table 8–29: Sub assemblies, WasherDriver
8.15.2 Message list
Table 8–30: Message list, WasherDriver
ID (dec) ID (hex) Name
1 0x01 Probe1
2 0x02 Probe2
3 0x03 Probe3
Message Description Action Effect Event ID
Aspiration failed for
3 consecutive
measurements at
washer port 1
Affected module:
Washer
• Perform the Initialization and
then the Bubble Sensor
calibration
• If the problem persists call
Service
L M S 228.001.00145
Aspiration failed for
3 consecutive
measurements at
washer port 2
Affected module:
Washer
• Perform the Initialization and
then the Bubble Sensor
calibration
• If the problem persists call
Service
L M S 228.002.00145
Aspiration failed for
3 consecutive
measurements at
washer port 3
Affected module:
Washer
• Perform the Initialization and
then the Bubble Sensor
calibration
• If the problem persists call
Service
L M S 228.003.00145
8. Troubleshooting and error messages
Page 8-24 LIAISON
®
XS - Instruction for use Rev. H
8.16 IncubatorDriver
Device ID: 0xE3
8.16.1 Sub assemblies
Table 8–31: Sub assemblies, IncubatorDriver
8.16.2 Message list
Table 8–32: Message list, IncubatorDriver
ID (dec) ID (hex) Name
0 0x00 General
Message Description Action Effect Event ID
Incubator (reaction)
temperature is out of
range.
- Environmental
• Wait for the temperature to be
back in range
• If the problem persists call
Service
Electronics
L M S 227.000.00032
Incubator (reaction)
temperature is back in
range
Only information Environmental
-
L 227.000.00033
Incubator (reaction)
temperature is out of
range for too long.
Affected module:
Incubator
Environmental
• Call Service
Electronics
L M S 227.000.00037
8. Troubleshooting and error messages
LIAISON
®
XS - Instruction for use Rev. H Page 8-25
8.17 ServiceDriver
Device ID: 0xE2
8.17.1 Sub assemblies
Table 8–33: Sub assemblies, ServiceDriver
8.17.2 Message list
Table 8–34: Message list, ServiceDriver
ID (dec) ID (hex) Name
0 0x00 General
Message Description Action Effect Event ID
Prime of {Module}
failed.
- InstrumentHandling
• Ensure that all needed
resources are correctly
loaded
• The system will try to perform
the failed prime before
starting the next routine,
maintenance task or resume
• If the problem persists call
Service
ProcessControl
L M S 226.000.00033
8. Troubleshooting and error messages
Page 8-26 LIAISON
®
XS - Instruction for use Rev. H
8.18 UserAccessDriver
Device ID: 0xE1
8.18.1 Sub assemblies
Table 8–35: Sub assemblies, UserAccessDriver
8.18.2 Message list
Table 8–36: Message list, UserAccessDriver
8.19 DiTiManager
Device ID: 0xD7
8.19.1 Sub assemblies
Table 8–37: Sub assemblies, DiTiManager
8.19.2 Message list
Table 8–38: Message list, DiTiManager
ID (dec) ID (hex) Name
0 0x00 General
Message Description Action Effect Event ID
Soft power button was
pressed.
Only information - L 225.000.00096
ID (dec) ID (hex) Name
0 0x00 General
Message Description Action Effect Event ID
Consumable tray(s)
unlocked for user
access
- ProcessControl L 215.000.00048
8. Troubleshooting and error messages
LIAISON
®
XS - Instruction for use Rev. H Page 8-27
8.20 LoadingManager
Device ID: 0xD6
8.20.1 Sub assemblies
Table 8–39: Sub assemblies, LoadingManager
8.20.2 Message list
Table 8–40: Message list, LoadingManager
ID (dec) ID (hex) Name
0 0x00 General
Message Description Action Effect Event ID
Instrument cover open
while an operation is in
progress
- InstrumentHandling
• Close the cover and initialize
the system
• If the error persists call
Service
L M S 214.000.00042
Solid waste has to be
present while operation
- InstrumentHandling
• Insert the solid waste bin and
initialize the system
• If the error persists call
Service
Electronics
L M S 214.000.00067
Liquid waste has to be
present while operation
- InstrumentHandling
• Plug the connector into the
liquid waste tank and initialize
the system
• If the error persists call
Service
Electronics
L M S 214.000.00068
8. Troubleshooting and error messages
Page 8-28 LIAISON
®
XS - Instruction for use Rev. H
8.21 Dispatcher
Device ID: 0xD4
8.21.1 Sub assemblies
Table 8–41: Sub assemblies, Dispatcher
8.21.2 Message list
Table 8–42: Message list, Dispatcher
ID (dec) ID (hex) Name
0 0x00 General
10x01LeftArm
Message Description Action Effect Event ID
System cycle belated
by {Delay}
- Configuration
• If the problem persists call
Service
Electronics
Mechanics
L M S 212.000.00034
system delay by
{Delay} in worklist
queue {QueueId}
occurred
Only information, a
recoverable delay
occurred
ProcessControl L M 212.000.00035
Pickup of diposable tip
failed
ProcessControl L 212.001.00096
Pressure threshold
exceeded by probe
(ADPM) for JobId
{JobId}
- ProcessControl L M 212.001.00104
8. Troubleshooting and error messages
LIAISON
®
XS - Instruction for use Rev. H Page 8-29
8.22 AssayManager
Device ID: 0xD3
8.22.1 Sub assemblies
Table 8–43: Sub assemblies, AssayManager
8.22.2 Message list
ID (dec) ID (hex) Name
0 0x00 General
Message Description Action Effect Event ID
It was not possible to correctly
handle the Assay protocol
- Configuration
• Call Service
L M 211.000.00032
It was not possible to correctly
handle the Assay protocol
- Configuration
• Call Service
L M 211.000.00033
It was not possible to correctly
handle the Assay protocol
- Configuration
• Call Service
L M 211.000.00034
It was not possible to correctly
handle the Assay protocol
- Configuration
• Call Service
L M 211.000.00035
It was not possible to correctly
handle the Assay protocol
- Configuration
• Call Service
L M 211.000.00036
It was not possible to correctly
handle the Assay protocol
- Configuration
• Call Service
L M 211.000.00037
It was not possible to correctly
handle the Assay protocol
- Configuration
• Call Service
L M 211.000.00038
It was not possible to correctly
handle the Assay protocol
- Configuration
• Call Service
L M 211.000.00039
It was not possible to correctly
handle the Assay protocol
- Configuration
• Call Service
L M 211.000.00040
It was not possible to correctly
handle the Assay protocol
- Configuration
• Call Service
L M 211.000.00041
It was not possible to correctly
handle the Assay protocol
- Configuration
• Call Service
L M 211.000.00042
It was not possible to correctly
handle the Assay protocol
- Configuration
• Call Service
L M 211.000.00043
It was not possible to correctly
handle the Assay protocol
- Configuration
• Call Service
L M 211.000.00044
It was not possible to correctly
handle the Assay protocol
- Configuration
• Call Service
L M 211.000.00045
8. Troubleshooting and error messages
Page 8-30 LIAISON
®
XS - Instruction for use Rev. H
Table 8–44: Message list, AssayManager
It was not possible to correctly
handle the Assay protocol
- Configuration
• Call Service
L M 211.000.00046
It was not possible to correctly
handle the Assay protocol
- Configuration
• Call Service
L M 211.000.00048
It was not possible to correctly
handle the Assay protocol
- Configuration
• Call Service
L M 211.000.00049
It was not possible to correctly
handle the Assay protocol
- Configuration
• Call Service
L M 211.000.00050
It was not possible to correctly
handle the Assay protocol
- Configuration
• Call Service
L M 211.000.00051
It was not possible to correctly
handle the Assay protocol
- Configuration
• Call Service
L M 211.000.00052
It was not possible to correctly
handle the Assay protocol
- Configuration
• Call Service
L M 211.000.00053
It was not possible to correctly
handle the Assay protocol
- Configuration
• Call Service
L M 211.000.00054
It was not possible to correctly
handle the Assay protocol
- Configuration
• Call Service
L M 211.000.00055
It was not possible to correctly
handle the Assay protocol
- Configuration
• Call Service
L M 211.000.00056
Sample pipetting step is used
more than once
- Configuration
• If the problem
persists call Service
L M S 211.000.00057
Message Description Action Effect Event ID
8. Troubleshooting and error messages
LIAISON
®
XS - Instruction for use Rev. H Page 8-31
8.23 JobManager
Device ID: 0xD2
8.23.1 Sub assemblies
Table 8–45: Sub assemblies, JobManager
8.23.2 Message list
ID (dec) ID (hex) Name
0 0x00 General
Message Description Action Effect Event ID
Same start cycle as a
job already
programmed. JobId
{JobIdentifier}
A scheduling error has
occurred.
Configuration
• Start the job again
• If the problem persists call
Service
L M S 210.000.00035
An internal error
occurred while
processing JobId
{JobIdentifier}
Data garbled Configuration
• If the problem persists call
Service
L M S 210.000.00036
An internal error
occurred while
processing JobId
{JobIdentifier}
No assay data Configuration
• Import the Assay Protocol
• Start the job again
• If the problem persists call
Service
L M S 210.000.00038
Required dilution
pipetting sequence not
stored. JobId
{JobIdentifier}
The dilution sequence
is missing
Configuration
• Call Service
L M S 210.000.00039
The number of
resources does not
match to the number
required by the assay.
JobId {JobIdentifier}
Wrong reagent
configuration
Configuration
• Call Service
L M S 210.000.00040
•
Maximum number of
reagents exceeded.
JobId {JobIdentifier}
Wrong reagent
configuration
Configuration
• Call Service
L M S 210.000.00042
•
Maximum number of
pre-treatments
exceeded. JobId
{JobIdentifier}
Wrong assay sequence Configuration
• Call Service
L M S 210.000.00044
8. Troubleshooting and error messages
Page 8-32 LIAISON
®
XS - Instruction for use Rev. H
Table 8–46: Message list, JobManager
Dilution volume out of
range. JobId
{JobIdentifier}
Wrong assay sequence Configuration
• Call Service
L M S 210.000.00045
Schedule conflict:
Phase is still in use.
JobId {JobIdentifier1}
and JobId
{JobIdentifier2}
A scheduling error has
occurred.
Configuration
• Initialize the system
• Start the jobs again
• If the problem persists call
Service
L M S 210.000.00049
Job rejected: Assay
sequence not
plausible. JobId
{JobIdentifier}
Wrong assay sequence Configuration
• Call Service
L M S 210.000.00050
An internal error
occurred while
processing
Invalid assay ID Configuration
• Call Service
L M S 210.000.00052
Message Description Action Effect Event ID
8. Troubleshooting and error messages
LIAISON
®
XS - Instruction for use Rev. H Page 8-33
8.24 FrontCover
Device ID: 0x40
8.24.1 Sub assemblies
Table 8–47: Sub assemblies, FrontCover
8.24.2 Message list
Table 8–48: Message list, FrontCover
ID (dec) ID (hex) Name
0 0x00 General
Message Description Action Effect Event ID
An internal error
occurred
Affected module: Front
Cover
Electronics
• If the problem persists call
Service
L M S 064.000.00004
A communication error
occurred
Affected module: Front
Cover
Electronics
• Initialize the system
• If the problem persists,
Switch-off, restart and
initialize the system
• If the problem persists call
Service
L M S 064.000.00005
8. Troubleshooting and error messages
Page 8-34 LIAISON
®
XS - Instruction for use Rev. H
8.25 WAP
Device ID: 0x35
8.25.1 Sub assemblies
Table 8–49: Sub assemblies, WAP
8.25.2 Message list
Table 8–50: Message list, WAP
ID (dec) ID (hex) Name
0 0x00 General
Message Description Action Effect Event ID
An internal error
occurred
Affected module: WAP Electronics
• If the problem persists call
Service
L M S 053.000.00004
A communication error
occurred
Affected module: WAP Electronics
• Initialize the system
• If the problem persists,
Switch-off, restart and
initialize the system
• If the problem persists call
Service
L M S 053.000.00005
Motor overload Affected module: WAP Electronics
• Initialize the system
• If the problem persists call
Service
Mechanics
L M S 053.000.00008
Target position reached
after retry.
Only information Electronics
-
Mechanics
L 053.000.00009
Target position not
reached by washer
pump
Affected module: WAP Electronics
• Initialize the system
• If the problem persists call
Service
Mechanics
L M S 053.000.00010
8. Troubleshooting and error messages
LIAISON
®
XS - Instruction for use Rev. H Page 8-35
8.26 WasherDispensePump
Device ID: 0x32
8.26.1 Sub assemblies
Table 8–51: Sub assemblies, WasherDispensePump
8.26.2 Message list
ID (dec) ID (hex) Name
0 0x00 General
Message Description Action Effect Event ID
An internal error
occurred
Affected module:
WBDP
Electronics
• If the problem persists call
Service
L M S 050.000.00004
A communication error
occurred
Affected module:
WBDP
Electronics
• Initialize the system
• If the problem persists,
Switch-off, restart and
initialize the system
• If the problem persists call
Service
L M S 050.000.00005
Motor overload Affected module:
WBDP
Electronics
• Initialize the system
• If the problem persists call
Service
Mechanics
L M S 050.000.00008
Target position reached
after retry.
Only information Electronics
-
Mechanics
L 050.000.00009
Target position not
reached by washer
pump
Affected module:
WBDP
Electronics
• Initialize the system
• If the problem persists call
Service
Mechanics
L M S 050.000.00010
Initialization of pump
failed
Affected module:
WBDP
Electronics
• If the problem persists call
Service
Mechanics
L M S 050.000.00032
Initialization of pump
failed
Affected module:
WBDP
Electronics
• If the problem persists call
Service
Mechanics
L M S 050.000.00033
8. Troubleshooting and error messages
Page 8-36 LIAISON
®
XS - Instruction for use Rev. H
Table 8–52: Message list, WasherDispensePump
An internal error
occurred
Affected module: WDP Calibration
• If the problem persists call
Service
Electronics
L M S 050.000.00176
An internal error
occurred
Affected module: WDP Configuration
• If the problem persists call
Service
Electronics
L M S 050.000.00180
Message Description Action Effect Event ID
8. Troubleshooting and error messages
LIAISON
®
XS - Instruction for use Rev. H Page 8-37
8.27 LiquidSupport
Device ID: 0x18
8.27.1 Sub assemblies
Table 8–53: Sub assemblies, LiquidSupport
8.27.2 Message list
Table 8–54: Message list, LiquidSupport
ID (dec) ID (hex) Name
0 0x00 General
1 0x01 BubbleSensor1
2 0x02 BubbleSensor2
50x05RFIDStarter
Message Description Action Effect Event ID
An internal error
occurred
Affected module:
Liquid Support
Electronics
• If the problem persists call Service
L M S 024.000.00004
A communication
error occurred
Affected module:
Liquid Support
Electronics
• Initialize the system
• If the problem persists, Switch-off,
restart and initialize the system
• If the problem persists call Service
L M S 024.000.00005
An Internal error
occurred during
self test
Affected module:
Liquid Support
Electronics
• Initialize the system
• If the problem persists, Switch-off,
restart and initialize the system
• If the problem persists call Service
L M S 024.000.00012
Bubble sensor 1
calibration error
Affected module:
Liquid Support
Calibration
• Initialize the system
• If the problem persists call Service
InstrumentHandling
L M S 024.001.00080
Bubble sensor 2
calibration error
Affected module:
Liquid Support
Calibration
• Initialize the system
• If the problem persists call Service
InstrumentHandling
L M S 024.002.00080
An error occurred
while accessing
RFTag
Affected module:
Starter Reagent
Bay
Consumable
• If the problem persists call Service
L M S 024.005.00130
8. Troubleshooting and error messages
Page 8-38 LIAISON
®
XS - Instruction for use Rev. H
8.28 LoadingBay
Device ID: 0x16
8.28.1 Sub assemblies
Table 8–55: Sub assemblies, LoadingBay
8.28.2 Message list
ID (dec) ID (hex) Name
0 0x00 General
30x03Stirrer
4 0x04 Cooling
1 0x01 Loading
5 0x05 Scanner
2 0x02 RFID
Message Description Action Effect Event ID
An internal error
occurred
Affected module:
Loading Bay
Electronics
• If the problem persists call
Service
L M S 022.000.00004
A communication error
occurred
Affected module:
Loading Bay
Electronics
• Initialize the system
• If the problem persists,
Switch-off, restart and
initialize the system
• If the problem persists call
Service
L M S 022.000.00005
Target position reached
after retry.
Only information Electronics
-
Mechanics
L 022.003.00009
Target position not
reached by stirrer
Affected module:
Stirrer
Electronics
• Initialize the system
• If the problem persists call
Service
Mechanics
L M S 022.003.00010
A movement problem
has been detected
Affected module:
Stirrer
Mechanics
• Initialize the system
• If the problem persists call
Service
Electronics
L M S 022.003.00023
8. Troubleshooting and error messages
LIAISON
®
XS - Instruction for use Rev. H Page 8-39
Actual temperature is
not in allowed range
defined by parameters.
- Environmental
• Check module environment
(temperature, humidity)
• Exchange module
Configuration
• Check instrument
configuration
• Run Instrument Setup
• Call manufacturer
L 022.000.00033
Reagents temperature
is out of range
The system is still
initializing or resuming;
The system was shut
down for a long time;
Hardware defect
Environmental
• Wait for the temperature to be
back in range
• If the problem persists call
Service
Configuration
L S 022.004.00033
Actual temperature is
back in allowed range
defined by parameters.
- Enviromental
• Check module environment
(temperature, humidity)
• Exchange module
ProcessControl
Configuration
• Check instrument
configuration
• Run Instrument Setup
• Call manufacturer
L 022.000.00034
Reagents temperature
is back in range
Only information Environmental
-
ProcessControl
Configuration
L 022.004.00034
Temperature sensor
fails plausibility check
Affected module:
Loading Bay
Electronics
• Initialize the system
• If the problem persists,
Switch-off, restart and
initialize the system
• If the problem persists call
Service
Configuration
L M S 022.000.00035
Temperature sensor
fails plausibility check
Affected module:
Loading Bay
Electronics
• Initialize the system
• If the problem persists,
Switch-off, restart and
initialize the system
• If the problem persists call
Service
Configuration
L M S 022.004.00035
Message Description Action Effect Event ID
8. Troubleshooting and error messages
Page 8-40 LIAISON
®
XS - Instruction for use Rev. H
Seebeck voltage too
low
Affected module:
Loading Bay
Electronics
• If the problem persists call
Service
Mechanics
L M 022.004.00037
Seebeck voltage too
high
Affected module:
Loading Bay
Electronics
• Initialize the system
• If the problem persists,
Switch-off, restart and
initialize the system
• If the problem persists call
Service
Mechanics
L M 022.004.00038
Temperature sensor
fails plausibility check
Affected module:
Loading Bay
Electronics
• If the problem persists call
Service
Configuration
L M S 022.004.00043
Initialization of stirrer
failed
Affected module:
Stirrer
Electronics
• Initialize the system
• If the problem persists,
Switch-off, restart and
initialize the system
• If the problem persists call
Service
Mechanics
L M S 022.003.00048
Initialization of stirrer
failed
Affected module:
Stirrer
Electronics
• Initialize the system
• If the problem persists,
Switch-off, restart and
initialize the system
• If the problem persists call
Service
Mechanics
L M S 022.003.00049
Stirrer motor rotation
error fequency too low
- Electronics
Mechanics
• If the problem persists call
Service
L M S 022.003.00052
Not plausible barcode
read. It may be that
rack insertion took too
long
- InstrumentHandling
• Reload the rack
• If the problem persists,
initialize the system then
reload the rack
• If the problem persists call
Service
L M 022.001.00083
An Internal error
occurred
Affected module:
Barcode Scanner
Electronics
• Initialize the system
• If the problem persists call
Service
L M S 022.005.00096
Message Description Action Effect Event ID
8. Troubleshooting and error messages
LIAISON
®
XS - Instruction for use Rev. H Page 8-41
Table 8–56: Message list, LoadingBay
8.29 PumpStarter2
Device ID: 0x14
8.29.1 Sub assemblies
Table 8–57: Sub assemblies, PumpStarter2
8.29.2 Message list
An Internal error
occurred
Affected module:
Barcode Scanner
Electronics
• Initialize the system
• If the problem persists,
Switch-off, restart and
initialize the system
• If the problem persists call
Service
Configuration
L M S 022.005.00097
Barcode length
exceeds limits
-Consumable
Configuration
L 022.001.00116
An error occurred while
accessing RFTag
Affected module:
Loading Bay
Consumable
• If the problem persists call
Service
L M S 022.002.00130
Message Description Action Effect Event ID
ID (dec) ID (hex) Name
7 0x07 General
Message Description Action Effect Event ID
An internal error
occurred
Affected module:
Starter Pump 2
Electronics
• If the problem persists call
Service
L M S 020.007.00004
A communication error
occurred
Affected module:
Starter Pump 2
Electronics
• Initialize the system
• If the problem persists,
Switch-off, restart and
initialize the system
• If the problem persists call
Service
L M S 020.007.00005
Motor overload Affected module:
Starter Pump 2
Electronics
• Initialize the system
• If the problem persists call
Service
Mechanics
L M S 020.007.00008
8. Troubleshooting and error messages
Page 8-42 LIAISON
®
XS - Instruction for use Rev. H
Table 8–58: Message list, PumpStarter2
8.30 PumpStarter1
Device ID: 0x14
8.30.1 Sub assemblies
Table 8–59: Sub assemblies, PumpStarter1
Target position reached
after retry.
Only information Electronics
-
Mechanics
L 020.007.00009
Target position not
reached by pump
Affected module:
Starter Pump 2
Electronics
• Initialize the system
• If the problem persists call
Service
Mechanics
L M S 020.007.00010
Initialization of pump
failed
Affected module:
Starter Pump 2
Electronics
• If the problem persists call
Service
Mechanics
L M S 020.007.00032
Initialization of pump
failed
Affected module:
Starter Pump 2
Electronics
• If the problem persists call
Service
Mechanics
L M S 020.007.00033
An internal error
occurred
Affected module:
Starter Pump 2
Calibration
• If the problem persists call
Service
Electronics
L M S 020.007.00176
An internal error
occurred
Affected module:
Starter Pump 2
Configuration
• If the problem persists call
Service
Electronics
L M S 020.007.00180
Message Description Action Effect Event ID
ID (dec) ID (hex) Name
6 0x06 General
8. Troubleshooting and error messages
LIAISON
®
XS - Instruction for use Rev. H Page 8-43
8.30.2 Message list
Table 8–60: Message list, PumpStarter1
Message Description Action Effect Event ID
An internal error
occurred
Affected module:
Starter Pump 1
Electronics
• If the problem persists call
Service
L M S 020.006.00004
A communication error
occurred
Affected module:
Starter Pump 1
Electronics
• Initialize the system
• If the problem persists,
Switch-off, restart and
initialize the system
• If the problem persists call
Service
L M S 020.006.00005
Motor overload Affected module:
Starter Pump 1
Electronics
• Initialize the system
• If the problem persists call
Service
Mechanics
L M S 020.006.00008
Target position reached
after retry.
Only information Electronics
-
Mechanics
L 020.006.00009
Target position not
reached by pump
Affected module:
Starter Pump 1
Electronics
• Initialize the system
• If the problem persists call
Service
Mechanics
L M S 020.006.00010
Initialization of pump
failed
Affected module:
Starter Pump 1
Electronics
• If the problem persists call
Service
Mechanics
L M S 020.006.00032
Initialization of pump
failed
Affected module:
Starter Pump 1
Electronics
• If the problem persists call
Service
Mechanics
L M S 020.006.00033
An internal error
occurred
Affected module:
Starter Pump 1
Calibration
• If the problem persists call
Service
Electronics
L M S 020.006.00176
An internal error
occurred
Affected module:
Starter Pump 1
Configuration
• If the problem persists call
Service
Electronics
L M S 020.006.00180
8. Troubleshooting and error messages
Page 8-44 LIAISON
®
XS - Instruction for use Rev. H
8.31 Measurement
Device ID: 0x14
8.31.1 Sub assemblies
Table 8–61: Sub assemblies, Measurement
8.31.2 Message list
ID (dec) ID (hex) Name
0 0x00 General
2 0x02 Rotor
3 0x03 Lift
1 0x01 Measurement
5 0x05 BubbleSensor
Message Description Action Effect Event ID
An internal error
occurred
Affected module:
Reader
Electronics
• If the problem persists call
Service
L M S 020.000.00004
A communication error
occurred
Affected module:
Reader
Electronics
• Initialize the system
• If the problem persists,
Switch-off, restart and
initialize the system
• If the problem persists call
Service
L M S 020.000.00005
Target position reached
after retry.
Only information Electronics
-
Mechanics
L 020.002.00009
Target position reached
after retry.
Only information Electronics
-
Mechanics
L 020.003.00009
Target position not
reached by rotor
Affected module:
Reader
Electronics
• Initialize the system
• If the problem persists call
Service
Mechanics
L M S 020.002.00010
Target position not
reached by lift
Affected module:
Reader
Electronics
• Initialize the system
• If the problem persists call
Service
Mechanics
L M S 020.003.00010
8. Troubleshooting and error messages
LIAISON
®
XS - Instruction for use Rev. H Page 8-45
High Voltage out of
range.
Affected module:
Reader
Electronics
• Call Service
L M S 020.001.00033
An Internal error
occurred
Affected module:
Reader
Mechanics
• Call Service
Electronics
L M S 020.000.00034
An Internal error
occurred
Affected module:
Reader
Electronics
• Call Service
L M S 020.000.00035
Measured High voltage
reference is out of
allowed range
Affected module:
Reader
Electronics
• Call Service
L M S 020.001.00037
Initialization of lift failed Affected module:
Reader
Mechanics
• Initialize the system
• If the problem persists,
Switch-off, restart and
initialize the system
• If the problem persists call
Service
Electronics
L M S 020.003.00048
Initialization of rotor
failed
Affected module:
Reader
Mechanics
• Initialize the system
• If the problem persists,
Switch-off, restart and
initialize the system
• If the problem persists call
Service
Electronics
L M S 020.002.00048
Initialization of lift failed Affected module:
Reader
Mechanics
• Initialize the system
• If the problem persists,
Switch-off, restart and
initialize the system
• If the problem persists call
Service
Electronics
L M S 020.003.00049
Initialization of rotor
failed
Affected module:
Reader
Mechanics
• Initialize the system
• If the problem persists,
Switch-off, restart and
initialize the system
• If the problem persists call
Service
Electronics
L M S 020.002.00049
Target position not
reached by rotor
Affected module:
Reader
Mechanics
• Initialize the system
• If the problem persists call
Service
L M S 020.002.00057
Message Description Action Effect Event ID
8. Troubleshooting and error messages
Page 8-46 LIAISON
®
XS - Instruction for use Rev. H
Table 8–62: Message list, Measurement
Target position not
reached by rotor
Affected module:
Reader
Mechanics
• Initialize the system
• If the problem persists call
Service
L M S 020.002.00059
Detected Fan
frequency out of
allowed range.
- Electronics
• If the problem persists call
Service
L M S 020.000.00065
Detected Fan
frequency is back in
range.
Only information Electronics
-
L 020.000.00066
Detected Fan
frequency is invalid.
- Electronics
• Call Service
L M S 020.000.00067
Target position not
reached by lift
Affected module:
Reader
Mechanics
• Initialize the system
• If the problem persists call
Service
Calibration
L M S 020.003.00083
Bubble sensor can not
be calibrated or still
isn't calibrated.
Affected module:
Reader
Calibration
• Perform the Initialization and
then the Bubble Sensor
calibration
• If the problem persists call
Service
InstrumentHandling
L M S 020.005.00144
Message Description Action Effect Event ID
8. Troubleshooting and error messages
LIAISON
®
XS - Instruction for use Rev. H Page 8-47
8.32 Washer
Device ID: 0x13
8.32.1 Sub assemblies
Table 8–63: Sub assemblies, Washer
8.32.2 Message list
ID (dec) ID (hex) Name
0 0x00 General
1 0x01 Probe1
2 0x02 Probe2
3 0x03 Probe3
4 0x04 Ring
Message Description Action Effect Event ID
An internal error
occurred
Affected module:
Washer
Electronics
• If the problem persists call
Service
L M S 019.000.00004
A communication error
occurred
Affected module:
Washer
Electronics
• Initialize the system
• If the problem persists,
Switch-off, restart and
initialize the system
• If the problem persists call
Service
L M S 019.000.00005
Target position reached
after retry.
Only information Mechanics
-
Electronics
L 019.001.00009
Target position reached
after retry.
Only information Mechanics
-
Electronics
L 019.002.00009
Target position reached
after retry.
Only information Mechanics
-
Electronics
L 019.003.00009
Target position reached
after retry.
Only information Mechanics
-
Electronics
L 019.004.00009
Target position not
reached by probe 1
Affected module:
Washer
Mechanics
• Initialize the system
• If the problem persists call
Service
Electronics
L M S 019.001.00010
8. Troubleshooting and error messages
Page 8-48 LIAISON
®
XS - Instruction for use Rev. H
Target position not
reached by probe 2
Affected module:
Washer
Mechanics
• Initialize the system
• If the problem persists call
Service
Electronics
L M S 019.002.00010
Target position not
reached by probe 3
Affected module:
Washer
Mechanics
• Initialize the system
• If the problem persists call
Service
Electronics
L M S 019.003.00010
Target position not
reached by rotor
Affected module:
Washer
Mechanics
• Initialize the system
• If the problem persists call
Service
Electronics
L M S 019.004.00010
A movement problem
has been detected
Affected module:
Washer
Mechanics
• Initialize the system
• If the problem persists call
Service
Electronics
L M S 019.000.00023
Initialization of probe 1
failed
Affected module:
Washer
Mechanics
• Initialize the system
• If the problem persists,
Switch-off, restart and
initialize the system
• If the problem persists call
Service
Electronics
L M S 019.001.00034
Initialization of probe 2
failed
Affected module:
Washer
Mechanics
• Initialize the system
• If the problem persists,
Switch-off, restart and
initialize the system
• If the problem persists call
Service
Electronics
L M S 019.002.00034
Initialization of probe 3
failed
Affected module:
Washer
Mechanics
• Initialize the system
• If the problem persists,
Switch-off, restart and
initialize the system
• If the problem persists call
Service
Electronics
L M S 019.003.00034
Message Description Action Effect Event ID
8. Troubleshooting and error messages
LIAISON
®
XS - Instruction for use Rev. H Page 8-49
Initialization of rotor
failed
Affected module:
Washer
Mechanics
• Initialize the system
• If the problem persists,
Switch-off, restart and
initialize the system
• If the problem persists call
Service
Electronics
L M S 019.004.00034
Initialization of probe 1
failed
Affected module:
Washer
Mechanics
• Initialize the system
• If the problem persists,
Switch-off, restart and
initialize the system
• If the problem persists call
Service
Electronics
L M S 019.001.00035
Initialization of probe 2
failed
Affected module:
Washer
Mechanics
• Initialize the system
• If the problem persists,
Switch-off, restart and
initialize the system
• If the problem persists call
Service
Electronics
L M S 019.002.00035
Initialization of probe 3
failed
Affected module:
Washer
Mechanics
• Initialize the system
• If the problem persists,
Switch-off, restart and
initialize the system
• If the problem persists call
Service
Electronics
L M S 019.003.00035
Initialization of rotor
failed
Affected module:
Washer
Mechanics
• Initialize the system
• If the problem persists,
Switch-off, restart and
initialize the system
• If the problem persists call
Service
Electronics
L M S 019.004.00035
Target position not
reached by probe 1
Affected module:
Washer
Mechanics
• Initialize the system
• If the problem persists call
Service
Electronics
L M S 019.001.00067
Message Description Action Effect Event ID
8. Troubleshooting and error messages
Page 8-50 LIAISON
®
XS - Instruction for use Rev. H
Table 8–64: Message list, Washer
Target position not
reached by probe 2
Affected module:
Washer
Mechanics
• Initialize the system
• If the problem persists call
Service
Electronics
L M S 019.002.00067
Target position not
reached by probe 3
Affected module:
Washer
Mechanics
• Initialize the system
• If the problem persists call
Service
Electronics
L M S 019.003.00067
Target position not
reached by rotor
Affected module:
Washer
Mechanics
• Initialize the system
• If the problem persists call
Service
Electronics
L M S 019.004.00080
An internal error
occurred
Affected module:
Washer
Calibration
• If the problem persists call
Service
Electronics
L M S 019.000.00176
An internal error
occurred
Affected module:
Washer
Configuration
• If the problem persists call
Service
Electronics
L M S 019.000.00180
Message Description Action Effect Event ID
8. Troubleshooting and error messages
LIAISON
®
XS - Instruction for use Rev. H Page 8-51
8.33 Incubator
Device ID: 0x12
8.33.1 Sub assemblies
Table 8–65: Sub assemblies, Incubator
8.33.2 Message list
Table 8–66: Message list, Incubator
ID (dec) ID (hex) Name
0 0x00 General
Message Description Action Effect Event ID
An internal error
occurred
Affected module:
Incubator
Electronics
• If the problem persists call Service
L M S 018.000.00004
A communication
error occurred
Affected module:
Incubator
Electronics
• Initialize the system
• If the problem persists, Switch-off,
restart and initialize the system
• If the problem persists call Service
L M S 018.000.00005
Motor overload Affected module:
Incubator
Electronics
• Initialize the system
• If the problem persists call Service
Mechanics
L M S 018.000.00008
Target position
reached after retry.
Only information Electronics
-
Mechanics
L 018.000.00009
Target position not
reached by rotor
Affected module:
Incubator
Electronics
• Initialize the system
• If the problem persists call Service
Mechanics
L M S 018.000.00010
An Incubator
movement problem
has been detected
- Electronics
• If the problem persists call Service
Mechanics
L M S 018.000.00043
An internal error
occurred
Affected module:
Incubator
Calibration
• If the problem persists call Service
Electronics
L M S 018.000.00176
An internal error
occurred
Affected module:
Incubator
Configuration
• If the problem persists call Service
Electronics
L M S 018.000.00180
8. Troubleshooting and error messages
Page 8-52 LIAISON
®
XS - Instruction for use Rev. H
8.34 UserAccessPanel
Device ID: 0x11
8.34.1 Sub assemblies
Table 8–67: Sub assemblies, UserAccessPanel
8.34.2 Message list
Table 8–68: Message list, UserAccessPanel
8.35 PwrCanExtension
Device ID: 0x10
8.35.1 Sub assemblies
Table 8–69: Sub assemblies, PwrCanExtension
8.35.2 Message list
Table 8–70: Message list, PwrCanExtension
ID (dec) ID (hex) Name
0 0x00 General
Message Description Action Effect Event ID
An internal error
occurred
- Electronics
• If the problem persists call Service
L M S 017.000.00004
A communication
error occurred
- Electronics
• Initialize the system
• If the problem persists, Switch-off,
restart and initialize the system
• If the problem persists call Service
L M S 017.000.00005
ID (dec) ID (hex) Name
0 0x00 General
Message Description Action Effect Event ID
An internal error
occurred
- Electronics
• If the problem persists call Service
L M S 016.000.00004
A communication
error occurred
- Electronics
• Initialize the system
• If the problem persists, Switch-off, restart
and initialize the system
• If the problem persists call Service
L M S 016.000.00005
8. Troubleshooting and error messages
LIAISON
®
XS - Instruction for use Rev. H Page 8-53
8.36 COP
Device ID: 0x00
8.36.1 Sub assemblies
Table 8–71: Sub assemblies, COP
8.36.2 Message list
Table 8–72: Message list, COP
ID (dec) ID (hex) Name
0 0x00 General
2 0x02 CopCom
Message Description Action Effect Event ID
An internal error
occurred
Affected module: COP Electronics
• If the problem persists call
Service
L M S 000.000.00004
A communication error
occurred
- Electronics
• Initialize the system
• If the problem persists,
Switch-off, restart and
initialize the system
• If the problem persists call
Service
L M S 000.000.00005
An Internal error
occurred during self
test
- Electronics
• Initialize the system
• If the problem persists,
Switch-off, restart and
initialize the system
• If the problem persists call
Service
L M S 000.000.00012
No communication
from PC for too long
time.
- Electronics
• Initialize the system
• If the problem persists,
Switch-off, restart and
initialize the system
• If the problem persists call
Service
Configuration
L M S 000.002.00050
Change to FSE
operation mode to {
Mode }.
Affected module: COP Configuration
• Call Service
Subsequent
L M S 000.000.00160
8. Troubleshooting and error messages
Page 8-54 LIAISON
®
XS - Instruction for use Rev. H
8.37 QCStat
Device ID: 0x202
8.37.1 Sub assemblies
Table 8–73: Sub assemblies, QCStat
8.37.2 Message list
Table 8–74: Message list, QCStat
ID (dec) ID (hex) Name
0 0x00 RulePassed
Message Description Action Effect Event ID
Quality Control {0} for
analyzer '{1}', assay '{2}',
control name '{3}' at {4}.
The rule type was '{5}' with the
comment: '{6}'.
Only information - L M S 514.000.00001
Quality Control {0} for
analyzer '{1}', assay '{2}',
control name '{3}' at {4}.
The rule type was '{5}' with the
comment: '{6}'.
Only information - L M S 514.000.00002
Quality Control gets informed
for analyzer '{0}', assay '{1}',
control name '{2}'.
Only information - L 514.000.00003
Communication error with
Quality Control occurred.
Please check if all controls are
in range.
QC-Stats might be
out-of-sync due to
communication error.
• Please call Customer
Service.
L M 514.000.00004
8. Troubleshooting and error messages
LIAISON
®
XS - Instruction for use Rev. H Page 8-55
8.38 Backup
Device ID: 0x201
8.38.1 Sub assemblies
Table 8–75: Sub assemblies, Backup
8.38.2 Message list
Table 8–76: Message list, Backup
ID (dec) ID (hex) Name
0 0x00 DefinitionFileNotFound
Message Description Action Effect Event ID
The configuration file {0}
containing the backup
definitions was not found.
- • Call Service L M 513.000.00001
The backup operation
failed.
- • Retry to perform the Backup
• If problem persists call
Service
L S 513.000.00002
The backup type {0} is
not found in the backup
definitions file.
- • Call Service L 513.000.00003
The backup of the
database {0} failed.
- L 513.000.00004
Access denied to the
directory {0}
- • Call Service L 513.000.00005
Could not create backup
of database {0}.
An issue during the
access to Database
occured
• If the problem persists call
Service
L 513.000.00006
Could not copy backup
file(s). Error: {0}.
- • Call Service L 513.000.00007
Could not copy backup
file(s). The system
doesn't have permissions
to write in the destination
directory {0}
- • Ensure the system has the
permission to write in the
destination folder.
• If the problem persists call
Service
L 513.000.00008
There is not enough
space on {0} to copy the
file(s).
- • Ensure to have enough space
into the destination folder
• If the problem persists call
Service
L S 513.000.00009
Could not delete the
backup file(s). Error: {0}.
- • Restart the system
• If problem re-occurs call
Service
L M S 513.000.00010
A Low Level Message
was sent.
Only information - L M 515.000.00001
8. Troubleshooting and error messages
Page 8-56 LIAISON
®
XS - Instruction for use Rev. H
8.39 AutoBackup
Device ID: 0x201
8.39.1 Sub assemblies
Table 8–77: Sub assemblies, AutoBackup
8.39.2 Message list
Table 8–78: Message list, AutoBackup
ID (dec) ID (hex) Name
1 0x01 SecondPathDoesNotExist
Message Description Action Effect Event ID
Could not copy
autobackup file {0}.
Target directory {1}
does not exist.
- • Ensure that the destination folder
is available for the system.
• If the problem persists call Service
L M S 513.001.00001
Could not copy
autobackup file {0}.
- • If the problem persists call Service L M S 513.001.00002
Autobackup operation
failed.
- • Check availability of the
destination path (e.g. network
path, USB)
• If the problem persists call Service
L M S 513.001.00003
8. Troubleshooting and error messages
LIAISON
®
XS - Instruction for use Rev. H Page 8-57
8.40 DataReduction
Device ID: 0x200
8.40.1 Sub assemblies
Table 8–79: Sub assemblies, DataReduction
8.40.2 Message list
Table 8–80: Message list, DataReduction
ID (dec) ID (hex) Name
0 0x00 CalibrationSetToInvalidDue
ToKulovic
Message Description Action Effect Event ID
Calibration {0} set invalid
due to internal error
- • Repeat the calibration
• If problem persists call
Service
L S 512.000.00000
Invalidated Calibration
{0} due to max RLU CV.
Only information • Restart the calibration
• If problem persists replace
the kit
L S 512.000.00001
Invalidated Calibration
{0} due to deleted
calibrator result.
Only information - L M S 512.000.00004
Set Calibration {0} to
NotUsed due to
Calibration {1}.
Only information - L 512.000.00020
Set Calibration {0} to
NotUsedLot due to
Starter Lot Switch.
Only information - L 512.000.00021
Set Calibration {0} to
Expired.
Only information - L S 512.000.00022
Set Calibration {0} to
Disabled.
Only information - L 512.000.00023
8. Troubleshooting and error messages
Page 8-58 LIAISON
®
XS - Instruction for use Rev. H
8.41 TDef
Device ID: 0x1FF
8.41.1 Sub assemblies
Table 8–81: Sub assemblies, TDef
8.41.2 Message list
ID (dec) ID (hex) Name
0 0x00 ProcessInputDescriptionEx
ception
Message Description Action Effect Event ID
A communication issue between
PC and instrument e occurred
- • Call Service L 511.000.00001
It was not possible to correctly
handle the Assay protocol
- • Call Service L 511.000.00002
It was not possible to correctly
handle the Assay protocol
- • Call Service L 511.000.00003
It was not possible to correctly
handle the Assay protocol
- • Call Service L 511.000.00004
It was not possible to correctly
handle the Assay protocol
- • Call Service L 511.000.00005
It was not possible to correctly
handle the Assay protocol
- • Call Service L 511.000.00006
It was not possible to correctly
handle the Assay protocol
- • Call Service L 511.000.00010
It was not possible to correctly
handle the Assay protocol
- • Call Service L 511.000.00011
It was not possible to correctly
handle the Assay protocol
- • Call Service L 511.000.00025
It was not possible to correctly
handle the Assay protocol
- • Call Service L 511.000.00026
It was not possible to correctly
handle the Assay protocol
- • Call Service L 511.000.00027
It was not possible to correctly
handle the Assay Protocol
- • Call Service L 511.000.00033
It was not possible to correctly
handle the Assay protocol
- • Call Service L 511.000.00034
It was not possible to correctly
handle the Assay protocol
- • Call Service L 511.000.00035
8. Troubleshooting and error messages
LIAISON
®
XS - Instruction for use Rev. H Page 8-59
Table 8–82: Message list, TDef
8.42 ICoL
Device ID: 0x1FE
8.42.1 Sub assemblies
Table 8–83: Sub assemblies, ICoL
8.42.2 Message list
Table 8–84: Message list, ICoL
It was not possible to correctly
handle the Assay protocol
- • Call Service L 511.000.00037
It was not possible to correctly
handle the Assay protocol
- • Call Service L 511.000.00041
Message Description Action Effect Event ID
ID (dec) ID (hex) Name
0 0x00 UnknownMessage
Message Description Action Effect Event ID
A communication issue between
PC and instrument e occurred
- • Call Service L 510.000.00000
A communication issue between
PC and instrument e occurred
- • Call Service L 510.000.00001
A communication issue between
PC and instrument is occurred
- • Call Service L 510.000.00002
A communication issue between
PC and instrument e occurred
- • Call Service L M S 510.000.00003
A communication issue between
PC and instrument e occurred
- • Call Service L M S 510.000.00004
A communication issue between
PC and instrument e occurred
- • Call Service L M S 510.000.00005
A communication issue between
PC and instrument e occurred
- • Call Service L 510.000.00006
8. Troubleshooting and error messages
Page 8-60 LIAISON
®
XS - Instruction for use Rev. H
8.43 LIS
Device ID: 0x1FD
8.43.1 Sub assemblies
Table 8–85: Sub assemblies, LIS
8.43.2 Message list
Table 8–86: Message list, LIS
ID (dec) ID (hex) Name
0 0x00 NoResponseToQuery
Message Description Action Effect Event ID
No response to query
for workorder for SID
{0} within {1} seconds.
No response is
provided from the host
for that SID until the
timeout
• If the worklist for that SID was
correctly received, ignore it
• If no worklist was provided for
that SID, reload the involved
Sample
• If the problem persists call
Service
L 509.000.00001
Structure error in
received LIS message.
An error with the LIS
protocol is occurred
• Call Service L M S 509.000.00002
Error while transmitting
data to LIS.
An error in the LIS
communication
occurred
• Retry the transmission L M 509.000.00004
Liaison XS LIS module
running.
Only information • If the problem persists, call
service
L 509.000.00006
Liaison XS LIS module
stopped.
Only information - L 509.000.00007
Liaison XS LIS module
could not be started.
- • Make sure the cable between
the PC and the LIS system is
plugged in correctly
• Restart the PC
• If the problem persists call
Service
L M S 509.000.00008
Liaison XS LIS module
could not be stopped.
Only information - L M S 509.000.00009
Liaison XS LIS module
received an invalid
message (unsupported
message type or
structure error).
- • Retry the transmission
• If the problem persists call
Service
L M S 509.000.00010
8. Troubleshooting and error messages
LIAISON
®
XS - Instruction for use Rev. H Page 8-61
8.44 Reporting
Device ID: 0x1FC
8.44.1 Sub assemblies
Table 8–87: Sub assemblies, Reporting
8.44.2 Message list
Table 8–88: Message list, Reporting
ID (dec) ID (hex) Name
0 0x00 PrintError
Message Description Action Effect Event ID
An error occurred while
trying to print the
report.
Only information • Call Service L M S 508.000.00001
The printer settings are
not valid.
An error was detected
with printer
- L M S 508.000.00002
The printer status has
changed to online.
Only information - L 508.000.00003
The printer status has
changed to offline.
Only information - L 508.000.00004
8. Troubleshooting and error messages
Page 8-62 LIAISON
®
XS - Instruction for use Rev. H
8.45 UI
Device ID: 0x1FB
8.45.1 Sub assemblies
Table 8–89: Sub assemblies, UI
8.45.2 Message list
ID (dec) ID (hex) Name
0 0x00 ImportingAssayFile
Message Description Action Effect Event ID
Importing Assay File {0}. Only information - L 507.000.00000
Importing Assay with
Abbreviation {0}.
Only information - L 507.000.00001
Overwriting Assay with
Abbreviation {0} version {1}
with version {2}.
Only information - L 507.000.00002
Importing assay group file '{0}'. Only information - L 507.000.00003
Importing assay profile file '{0}'. Only information - L 507.000.00004
Exporting selected assay
group(s) to file '{0}'.
Only information - L 507.000.00005
Exporting selected assay
profile(s) to file '{0}'.
Only information - L 507.000.00006
Importing dilution sequences
file '{0}'.
Only information - L 507.000.00007
Importing rerun rules file '{0}'. Only information - L 507.000.00008
Exporting rerun rules file '{0}'. Only information - L 507.000.00009
Importing control definitions file
'{0}'.
Only information - L 507.000.00010
Exporting control definitions file
'{0}'.
Only information - L 507.000.00011
Assay '{0}' with article number
'{1}', name '{2}' and LIS alias
'{3}' deleted.
Only information - L 507.000.00012
Importing scanned control
definition '{0}', lot number '{1}',
barcode '{2}'.
Only information - L 507.000.00013
Importing scanned control
definition(s) failed.
- • Scan the control definition
again
• If the problem persists call
Service
L M 507.000.00014
Importing control definitions file
'{0}' failed.
Only information - L 507.000.00015
8. Troubleshooting and error messages
LIAISON
®
XS - Instruction for use Rev. H Page 8-63
Table 8–90: Message list, UI
Resetting User Unit, Normal
Range and Qualitative Labels
for Assay {0}.
Only information - L 507.000.00020
Overwriting Assay Master
Curve Unit from {0} to {1}.
Only information - L M 507.000.00021
Overwriting Assay Sample
Replicates Manufacturer from
{0} to {1}.
Only information - L M 507.000.00022
Overwriting Assay Control
Replicates Manufacturer from
{0} to {1}.
Only information - L M 507.000.00023
Overwriting Assay Assay
Range from {0} to {1}.
Only information - L M 507.000.00024
Overwriting Assay Share
Calibrations within Kit Lot
Manufacturer from {0} to {1}.
Only information - L M 507.000.00025
The Assay {0} is missing for
the Control Analyte Value.
Only information • Import the requested
Assay protocol
L M S 507.000.00030
The Control Definition {0} with
Lot {1} was not imported as no
matching assays was found in
the database
- • Import at least one of the
requested Assay protocols
and re-import the Control
Definition
L M 507.000.00031
Overwrite Control Definition {0}
with Lot {1}.
Only information - L 507.000.00032
Access rights imported. Only information - L 507.000.00040
Message Description Action Effect Event ID
8. Troubleshooting and error messages
Page 8-64 LIAISON
®
XS - Instruction for use Rev. H
8.46 Maintenance
Device ID: 0x1FA
8.46.1 Sub assemblies
Table 8–91: Sub assemblies, Maintenance
8.46.2 Message list
ID (dec) ID (hex) Name
0 0x00 ImportSuccessful
Message Description Action Effect Event ID
Maintenance import
finished successfully.
Only information - L 506.000.00003
An error occurred while
importing the
maintenance file
Only information • Call Service L M 506.000.00004
{0} maintenance task
completed
successfully.
Only information - L M 506.000.00007
Maintenance task {0}
started.
Only information - L 506.000.00011
Insufficient {0} for
starting this
maintenance task.
- • Ensure that the indicated
resource is enough for the
requested task
L M S 506.000.00012
Maintenance task
cannot be started.
Starter temperature is
out of range.
- • Ensure that the working
conditions are respected
• Allow the system to recover
• If the problem persists call
Service
L M 506.000.00013
Maintenance task
cannot be started.
Incubator temperature
is out of range.
- • Ensure that the working
conditions are respected
• Allow the system to recover
• If the problem persists call
Service
L M 506.000.00014
This maintenance task
cannot be started
because the instrument
is not in the correct
state
- - L M 506.000.00017
{0} maintenance task
aborted manually.
Only information - L M 506.000.00019
8. Troubleshooting and error messages
LIAISON
®
XS - Instruction for use Rev. H Page 8-65
Table 8–92: Message list, Maintenance
{0} maintenance task
failed.
- • Ensure all the needed
resources are loaded
• Restart the maintenance task
• If the problem persists call
Service
L M S 506.000.00020
A maintenance step is
not defined or is not
available.
- • Call Service L M 506.000.00024
A maintenance step
parameter was not
found.
- • Call Service L M 506.000.00025
All the parameters of a
maintenance task are
not correctly defined.
- • Call Service L M 506.000.00026
Error in maintenance
task definition.
- • Call Service L M 506.000.00027
Maintenance import
files are not valid xml
files.
- - L M 506.000.00029
Maintenance import file
version incompatible
with current Software.
- - L M 506.000.00030
Maintenance import file
has no XML schema
version specified.
- - L M 506.000.00031
Maintenance
procedure not available
for maintenance task.
Import failed.
- • Call Service L M 506.000.00033
Maintenance Task not
startable because
instrument in {0} state.
Ensure to be in Ready
or Standby
- L M 506.000.00034
Light check left is not
loaded.
Only information • Load the Light Check left and
restart the task
L S 506.000.00040
Light check right is not
loaded.
Only information • Load the Light Check right
and restart the task
L S 506.000.00041
Message Description Action Effect Event ID
8. Troubleshooting and error messages
Page 8-66 LIAISON
®
XS - Instruction for use Rev. H
8.47 Waste
Device ID: 0x1F9
8.47.1 Sub assemblies
Table 8–93: Sub assemblies, Waste
8.47.2 Message list
Table 8–94: Message list, Waste
ID (dec) ID (hex) Name
5 0x05 SolidWasteEmptied
Message Description Action Effect Event ID
Solid waste was
emptied.
Only information - L 505.005.00000
Solid waste is full. Only information • Empty the solid waste L S 505.005.00001
Solid waste was
removed, current level:
{0}.
Only information - L 505.005.00002
Solid waste was
inserted, current level:
{0}.
Only information - L 505.005.00003
Solid waste is nearly
full.
Only information - L M S 505.005.00004
Not enough solid waste
available for priming.
Only information • Empty the solid waste L M S 505.005.00005
Not enough liquid
waste available for
priming.
Only information • Empty the liquid waste L M S 505.005.00006
Not enough liquid
waste available for self
diagnostics.
Only information • Empty the liquid waste L M S 505.005.00007
Prime not possible
because solid waste is
not loaded.
Only information - L M S 505.005.00008
8. Troubleshooting and error messages
LIAISON
®
XS - Instruction for use Rev. H Page 8-67
8.48 TopCover
Device ID: 0x1F9
8.48.1 Sub assemblies
Table 8–95: Sub assemblies, TopCover
8.48.2 Message list
Table 8–96: Message list, TopCover
8.49 StarterLoading
Device ID: 0x1F9
8.49.1 Sub assemblies
Table 8–97: Sub assemblies, StarterLoading
ID (dec) ID (hex) Name
7 0x07 TopCoverOpenForPriming
Message Description Action Effect Event ID
Prime not possible because
top cover is open.
Only information • Close the top cover L M S 505.007.00000
Top Cover closed. Only information - L 505.007.00098
Top Cover opened. Only information - L 505.007.00099
ID (dec) ID (hex) Name
3 0x03 StarterRFIDDataBlockError
8. Troubleshooting and error messages
Page 8-68 LIAISON
®
XS - Instruction for use Rev. H
8.49.2 Message list
Table 8–98: Message list, StarterLoading
Message Description Action Effect Event ID
Starter {0} has wrong
RFID data block size.
- • Remove the Starter in error
and re-load it
• If the problem persists call
Service
L M S 505.003.00000
Starter {0} has wrong
identification: '{1}',
expected: '{2}'.
- • Remove the Starter in error
and re-load it
• If the problem persists call
Service
L M 505.003.00001
Starter {0} has wrong
CRC checksum.
- • Remove the Starter in error
and re-load it
• If the problem persists call
Service
L M 505.003.00002
Starter {0} inserted. Only information - L 505.003.00003
Starter from position {0}
removed.
Only information - L 505.003.00004
Starter in position {0}
shelf expired.
- • Replace the expired Starter
bottle
L M S 505.003.00005
Starter in use from
position {0} removed.
Only information - L M S 505.003.00006
Starter {0} lot has
changed and will
invalidate all
calibrations on prime.
Only information - L M 505.003.00007
Starter {0} lot switched
from {1} to {2}.
Only information - L 505.003.00008
Starter {0} taken offline. Bubbles were detected
in the Starter lines
• If the problem often occurs
call Service
L S 505.003.00009
Not enough Starter {0}
available for prime.
Only information • Replace the Starter bottle L M S 505.003.00010
Starter Flap closed. Only information - L 505.003.00098
Starter Flap opened. Only information - L 505.003.00099
8. Troubleshooting and error messages
LIAISON
®
XS - Instruction for use Rev. H Page 8-69
8.50 SampleLoading
Device ID: 0x1F9
8.50.1 Sub assemblies
Table 8–99: Sub assemblies, SampleLoading
8.50.2 Message list
ID (dec) ID (hex) Name
0 0x00 SampleRackInserted
Message Description Action Effect Event ID
Sample rack in lane {0}
inserted.
Only information - L S 505.000.00000
Sample rack from lane
{0} removed.
Only information - L 505.000.00001
Sample rack from lane
{0} removed while in
use.
A needed sample rack
was no longer available
to the system, either
because manually
removed or due to
instrument failure
• Reload the Sample Rack and
restart the failed jobs
• If problem persists call
Service
L M S 505.000.00002
Sample {0} in lane {1}
taken offline.
The sample tube is
offline; Possible
causes:;- Not enough
sample liquid;- Clot
detected;- Wrong Rack
used for the involved
tube
• Check the Sample integrity
(no foam, enough liquid)
• reload it in the appropriate
Rack
• Restart the job
• If the problem persists call
Service
L M S 505.000.00003
Invalid barcode found
in lane {0} position {1}:
'{2}'.
Only information • Ensure to use a compatible
barcode
• Check the label quality
• If the problem persists call
Service
L M 505.000.00004
Duplicate barcode
found in lane {0}
position {1}: '{2}'. The
same sample is
already loaded in lane
{3} position {4}.
In the loaded racks,
two or more Samples
carry the same ID. The
system kept the first
recognized tube only
• In case also the other tubes
shall be tested.
• Reload such tubes and
ensure that a unique barcode
is attached to each of them.
L M 505.000.00005
Invalid rack inserted
into lane {0}.
The system cannot
recognized the inserted
Rack type
• Call Service L 505.000.00006
RackID '{0}' manually
entered.
Only information - L 505.000.00007
Rack file '{0}' not found. Only information - L 505.000.00008
8. Troubleshooting and error messages
Page 8-70 LIAISON
®
XS - Instruction for use Rev. H
Table 8–100: Message list, SampleLoading
8.51 ReagentLoading
Device ID: 0x1F9
8.51.1 Sub assemblies
Table 8–101: Sub assemblies, ReagentLoading
8.51.2 Message list
Last read position
barcode does not
match the position
defined in the RAC file
in lane {0}.
- - L 505.000.00009
An aspiration error
occurred for sample {0}
in lane {1}
- • Ensure the tube contains the
needed amount of Sample
• Check Sample integrity
• Load the Sample tube in the
appropriate Rack
• Restart the job
• If the problem persists call
Service
LMS 505.000.00011
At least one position
barcode could not be
read in lane {0}.
- - L 505.000.00012
The Barcode {0} was
denied because
Barcode {1} is known in
the database. Case
conflict
- - L 505.000.00010
Sample Flap closed. Only information - L 505.000.00098
Sample Flap opened. Only information - L 505.000.00099
Message Description Action Effect Event ID
ID (dec) ID (hex) Name
1 0x01 IntegralShelfExpired
Message Description Action Effect Event ID
Integral in lane {0} for
assay {1} is shelf
expired.
- • Replace the expired Integral L M S 505.001.00000
Integral in lane {0} for
assay {1} is onboard
expired.
- • Check the product Instruction
For Use
L M S 505.001.00001
8. Troubleshooting and error messages
LIAISON
®
XS - Instruction for use Rev. H Page 8-71
Integral in lane {0} with
Article Number '{1}', Kit
Number '{2}' and Lot
Number '{3}' is already
loaded in the
instrument.
- • Remove the Integral in error
and re-load it in a different
lane.
• If the problem persists call
Service
L M 505.001.00002
Integral in lane {0} has
wrong identification:
'{1}', expected: '{2}'
- • Remove the Integral in error
and re-load it in a different
lane.
• If the problem persists call
Service.
L M S 505.001.00003
Integral in lane {0} has
wrong CRC checksum.
- • Remove the Integral in error
and re-load it in a different
lane.
• If the problem persists call
Service.
L M S 505.001.00004
Integral in lane {0} has
wrong RFID data block
size.
- • Remove the Integral in error
and re-load it in a different
lane.
• If the problem persists call
Service
L M S 505.001.00005
Integral in lane {0} set
offline as LLD is 0 while
remaining volume is
>0.
The system failed to
find the liquid in a vial
of the involved Integral
• If no used vial is exhausted,
check the proper Integral
conditions then use the
'Reset LLD' function.
• If an used vial is exhausted,
replace the Integral.
• If the problem often occurs
call Service.
L M S 505.001.00006
Integral {0} in lane {1}
inserted.
Only information - L 505.001.00010
Integral {0} from lane
{1} removed.
Only information - L 505.001.00011
Onboard stability
expired for integral {0}
in lane {1}.
- • Check the product Instruction
For Use
L M S 505.001.00012
Integral {0} from lane
{1} removed while in
use.
A needed Integral was
no longer available to
the system, either
because manually
removed or due to
instrument failure
• Reload the Integral and
restart the failed jobs.
• If problem persists call
Service.
L M S 505.001.00013
Integral in lane {0} has
wrong calibration block
CRC checksum.
- • Remove the Integral in error
and re-load it in a different
lane.
• If the problem persists call
Service.
L M S 505.001.00020
Message Description Action Effect Event ID
8. Troubleshooting and error messages
Page 8-72 LIAISON
®
XS - Instruction for use Rev. H
Table 8–102: Message list, ReagentLoading
Integral in lane {0} has
wrong combi block
CRC checksum.
- • Remove the Integral in error
and re-load it in a different
lane.
• If the problem persists call
Service
L M S 505.001.00021
Assay {0} has Version
{1}, but integrals needs
{2}.
The version of the
Assay protocol and the
one of the loaded
Integral do not match
• Ensure that the involved
Integral is compatible with the
revision of the loaded Assay.
• If the versions are not
compatible, either use a
compatible Integral kit or
import a compatible Assay
protocol revision.
• If no compatible Assay is
available download or acquire
it, then import it.
• If the error has been given
using compatible versions,
call Service.
L M S 505.001.00022
Integral {0} in lane {1}
taken offline (error in
position {2}).
- - L M S 505.001.00023
Integral {0} in lane {1}
disabled.
Only information - L 505.001.00024
Integral {0} in lane {1}
enabled.
Only information - L 505.001.00025
No Assay loaded for
the Integral in lane {0}
with the Article Number
{1}.
- • Import the needed Assay.
• If the problem persists call
Service.
L S 505.001.00026
Reset Liquid Levels on
Integral {0} in lane {1}.
Please unload and
reload that Integral
The reset of the liquid
levels of the Integral
has been successfully
completed and it is
necessary to unload
and re-load the Integral
to make it effective
- L M 505.001.00030
Rack file '{0}' not found. Only information - L 505.001.00032
Reagent Flap closed. Only information - L 505.001.00098
Reagent Flap opened. Only information - L 505.001.00099
Message Description Action Effect Event ID
8. Troubleshooting and error messages
LIAISON
®
XS - Instruction for use Rev. H Page 8-73
8.52 LiquidContainers
Device ID: 0x1F9
8.52.1 Sub assemblies
Table 8–103: Sub assemblies, LiquidContainers
8.52.2 Message list
Table 8–104: Message list, LiquidContainers
ID (dec) ID (hex) Name
6 0x06 WashBufferRemovedWhileI
nUse
Message Description Action Effect Event ID
Wash buffer was
removed while in use.
Only information - L M S 505.006.00000
Not enough wash
buffer available for
priming.
Only information • Refill the Wash Buffer L M S 505.006.00001
Not enough system
liquid available for
priming.
Only information • Refill the System Liquid L M S 505.006.00002
Not enough System
Liquid available for self
diagnostics.
Only information • Refill the System Liquid L M S 505.006.00003
System Liquid was
removed while in use.
Only information - L M S 505.006.00004
8. Troubleshooting and error messages
Page 8-74 LIAISON
®
XS - Instruction for use Rev. H
8.53 Consumables
Device ID: 0x1F9
8.53.1 Sub assemblies
Table 8–105: Sub assemblies, Consumables
8.53.2 Message list
Table 8–106: Message list, Consumables
ID (dec) ID (hex) Name
4 0x04 DrawerWithdrawRequest
Message Description Action Effect Event ID
Consumables Drawer was
requested to be removed
Only information - L 505.004.00000
Consumables Drawer was
removed while In Use.
Only information - L M 505.004.00001
Not enough cuvettes available
for priming.
Only information • Load Cuvettes L M S 505.004.00002
Warn Level for Cuvettes has
been reached
Only information - L S 505.004.00003
Warn Level for Cuvettes has
been left
Only information - L 505.004.00004
Warn Level for Disposable Tips
has been reached
Only information - L S 505.004.00005
Warn Level for Disposable Tips
has been left
Only information - L 505.004.00006
Consumables Drawer pushed
in.
Only information - L 505.004.00098
Consumables Drawer pulled
out.
Only information - L 505.004.00099
8. Troubleshooting and error messages
LIAISON
®
XS - Instruction for use Rev. H Page 8-75
8.54 AncillaryLoading
Device ID: 0x1F9
8.54.1 Sub assemblies
Table 8–107: Sub assemblies, AncillaryLoading
8.54.2 Message list
ID (dec) ID (hex) Name
2 0x02 AncillaryShelfExpired
Message Description Action Effect Event ID
Ancillary {0} in position
{1} is shelf expired.
- • Replace the expired Ancillary L M S 505.002.00000
Ancillary {0} in position
{1} is onboard expired.
- • Check the product Instruction
For Use
L M S 505.002.00001
Ancillary in position {0}
with Article Number
'{1}', Vial Number '{2}'
and Lot Number '{3}' is
already loaded in
another position.
- • Remove the Ancillary in error
and re-load it in a different
position.
• If the problem persists call
Service
L M 505.002.00002
Ancillary in position {0}
has wrong
identification: '{1}',
expected: '{2}'
- • Remove the Ancillary in error
and re-load it in a different
position.
• If the problem persists call
Service.
L M S 505.002.00003
Ancillary in position {0}
has wrong CRC
checksum.
- • Remove the Ancillary in error
and re-load it in a different
position.
• If the problem persists call
Service.
L M S 505.002.00004
Ancillary in position {0}
has wrong RFID data
block size.
- • Remove the Ancillary in error
and re-load it in a different
position.
• If the problem persists call
Service.
L M S 505.002.00005
Ancillary {0} in position
{1} disabled.
Only information - L 505.002.00006
Ancillary {0} in position
{1} enabled.
Only information - L 505.002.00007
Ancillary {0} in position
{1} inserted.
Only information - L 505.002.00010
Ancillary {0} from
position {1} removed.
Only information - L 505.002.00011
8. Troubleshooting and error messages
Page 8-76 LIAISON
®
XS - Instruction for use Rev. H
Table 8–108: Message list, AncillaryLoading
Needed Ancillary {0}
from position {1}
removed.
A needed Ancillary was
removed before that all
its programmed
aspirations were
completed
• Reload the Ancillary
• Re-start again the not started
jobs
L M S 505.002.00012
Onboard stability
expired for ancillary {0}
in position {1}.
- • Check the product Instruction
For Use
L M S 505.002.00013
Shelf expired for
ancillary {0} in position
{1}.
- • Replace the expired Ancillary L M S 505.002.00014
Ancillary {0} in position
{1} taken offline.
The system failed to
find the liquid in the
involved Ancillary vial
• If the Ancillary vial is not
exhausted and in proper
condition, re-load it for later
usage
• If the ancillary vial is
exhausted replace it
• If the problem persists call
Service
L M S 505.002.00015
Ancillary rack released. Only information - L 505.002.00016
Ancillary rack removed
without release.
Only information - L M S 505.002.00017
Needed Ancillary {0} at
position {1} inserted.
Only information - L M 505.002.00018
Needed Ancillary {0}
from position {1}
removed and not
reinserted.
A needed ancillary was
not reloaded or it was
reloaded but not in the
expected position.
• Relaod the needed ancillary
in the expected position
L S 505.002.00019
Message Description Action Effect Event ID
8. Troubleshooting and error messages
LIAISON
®
XS - Instruction for use Rev. H Page 8-77
8.55 Infrastructure
Device ID: 0x1F8
8.55.1 Sub assemblies
Table 8–109: Sub assemblies, Infrastructure
8.55.2 Message list
ID (dec) ID (hex) Name
0 0x00 VigilantOnlineFieldGateway
ServiceConnected
1 0x01 EventCreationException
2 0x02 DeskShieldLanguageFileN
otFoundException
3 0x03 WindowsTimeChanged
Message Description Action Effect Event ID
Connected to
FieldGateway Service.
Only information - L 504.000.00000
Failed to connect to the
DoT system: The
connection to the
FieldGateway Service
is failed.
- • Disable and Enable the DoT
module
• Restart the PC
• If the problem persists call
Service
L M 504.000.00001
The system has been
disconnected from
FieldGateway Service.
Only information - L 504.000.00002
Connected to DoT
system.
Only information - L 504.000.00003
The system has been
disconnected from DoT
system.
Only information - L 504.000.00004
DoT asked for the files:
{0}.
Only information - L 504.000.00005
DoT asked for the files:
{0} from {1} to {2}.
Only information - L 504.000.00006
Uploaded file {0} to
DoT.
Only information - L 504.000.00007
Connected to DoT
FastTrack service
The service for
downloading
instrument packages
from DiaSorin online
repository is connected
- L 504.000.00008
8. Troubleshooting and error messages
Page 8-78 LIAISON
®
XS - Instruction for use Rev. H
The connection to the
DoT system is
temporarily interrupted.
The DoT services may
be temporarily not
available
• If problem persists, call
Service
L 504.000.00009
Failed to connect to the
DoT system: the
authentication failed.
The DoT services may
be temporarily not
available
• If problem persists, call
Service
L 504.000.00010
Failed to connect to the
DoT system: an
interfacing error
occured
The DoT services may
be temporarily not
available
• If problem persists, call
Service
L 504.000.00011
Failed to connect to the
DoT system:
connection was denied
by the DoT
provisioning service.
The DoT services may
be temporarily not
available
• If problem persists, call
Service
L 504.000.00012
The internet
connection to DoT is
currently interrupted.
The DoT services may
be temporarily not
available
• Disconnect and reconnect the
instrument to DoT from the
System Setting IoT dedicated
page
• If the problem persists, check
the network cable
• If the problem persists,
contact the Laboratory IT to
check network availability
• If the problem persists, call
Service
L 504.000.00013
Failed to connect to the
DoT system: an error
occured at the DoT
Hub.
The DoT services may
be temporarily not
available
• If problem persists, call
Service
L 504.000.00014
Failed to connect to
DoT FastTrack service.
The service for
downloading
instrument packages
from DiaSorin online
repository may be
temporarily not
available
• If problem persists, call
Service
L 504.000.00015
An error occurred
during the connection
to DoT.
The DoT services may
be temporarily not
available
• Try to connect to DoT again
• If the problem persists, check
the network cable
• If the problem persists,
contact the Laboratory IT to
check that the network policy
have been correctly set to
allow the connection for the
DoT services
• If the problem persists, call
Service
L 504.000.00017
Message Description Action Effect Event ID
8. Troubleshooting and error messages
LIAISON
®
XS - Instruction for use Rev. H Page 8-79
Table 8–110: Message list, Infrastructure
Failed to connect to the
DoT system: The
connection to the
FieldGateway Service
is interrupted.
The DoT services may
be temporarily not
available
• If problem persists, call
Service
504.000.00018
The connection to DoT
is available.
Only information - L 504.000.00019
The system has been
disconnected from DoT
Fast Track
Only information. The
service for
downloading
instrument packages
from DiaSorin online
repository has been
disconnected
- L 504.000.00021
The connection to the
DoT Fast Track is
temporarily interrupted.
The service for
downloading
instrument packages
from DiaSorin online
repository may be
temporarily not
available
• If problem persists, call
Service
L 504.000.00022
Registration to DoT
succeeded.
Only information - L 504.000.00030
Registration to DoT
failed
The DoT services may
be temporarily not
available
• If problem persists, call
Service
L 504.000.00031
The requested {0}
download is still
ongoing.
Only information - L 504.000.00032
An error occured
creating Event Log
Entry for {0}.
- • Call Service L M S 504.001.00000
The system could not
find the desktop shield
language file.
The Desktop Shield is
not available in the
selected SW language;
The English one will be
used
• Call Service L 504.002.00000
The system could not
update the desktop
shield language file.
- • Call Service L 504.002.00001
The Windows Time
was changed while
LiaisonXS was
running.
Only information - L 504.003.00000
Trace files up to {0}
deleted.
Only information • If the message re-occurs, call
Service
L M 504.004.00001
Message Description Action Effect Event ID
8. Troubleshooting and error messages
Page 8-80 LIAISON
®
XS - Instruction for use Rev. H
8.56 ProcessControl
Device ID: 0x1F7
8.56.1 Sub assemblies
Table 8–111: Sub assemblies, ProcessControl
8.56.2 Message list
ID (dec) ID (hex) Name
0 0x00 JobScheduled
1 0x01 AbortOngoingJobOnSWSta
rtOrInitialization
Message Description Action Effect Event ID
Scheduled Job {0} {1} for
Cycle {2} with JobId {3}
(Replicate: {4}, Dilution:
{5}, Finish {6}, Integral
Lane {7}).
Only information - L 503.000.00000
Unscheduled Job {0} {1}
{2} {3} for Cycle {4} JobId
{5}.
Only information - L 503.000.00001
Started Job {0} {1} {2} {3}
for Cycle {4} JobId {5}.
Only information - L 503.000.00002
Started Mitigation {0} for
cycle {1} phase {2} JobId
{3}.
Only information - L 503.000.00003
The Start button was
pressed
Only information - L 503.000.00004
Could not schedule Job
{0} {1} (Replicate: {2}
Dilution: {3}), no system
liquid.
Not enough System
Liquid for the
requested job
• Ensure that the System
Liquid tank is primed and its
amount is sufficient for the
requested routine
• Start the job again
• If the problem persists call
Service
L M S 503.000.00009
Start Jobs that were
created by a rerun rule.
Only information - L 503.000.00010
A scheduling error
occurred
- • If the problem persists call
Service
L M S 503.000.00011
8. Troubleshooting and error messages
LIAISON
®
XS - Instruction for use Rev. H Page 8-81
Could not schedule Job
{0} {1} (Replicate: {2}
Dilution: {3}), no wash
buffer.
Not enough Wash
Buffer for the
requested job
• Ensure that the Wash
Buffer tank is primed and its
amount is sufficient for the
requested routine
• Start the job again
• If the problem persists call
Service
L M S 503.000.00012
Could not schedule Job
{0} {1} (Replicate: {2}
Dilution: {3}), no cuvette.
Not enough Cuvettes
for the requested job
• Ensure that the number of
loaded Cuvettes is sufficient
for the requested routine
• Start the job again
• If the problem persists call
Service
L M S 503.000.00013
Could not schedule Job
{0} {1} (Replicate: {2}
Dilution: {3}), no
disposable tip.
Not enough Tips for the
requested job
• Ensure that the number of
loaded Tips is sufficient for
the requested routine
• Start the job again
• If the problem persists call
Service
L M S 503.000.00014
Could not schedule Job
{0} {1} (Replicate: {2}
Dilution: {3}), no solid
waste.
Not enough space in
the solid waste for the
requested job
• Empty the solid waste
• Start the job again
• If the problem persists call
Service
L M S 503.000.00015
Could not schedule Job
{0} {1} (Replicate: {2}
Dilution: {3}), no starter.
Not enough Starters for
the requested job
• Ensure that the Starter
bottles are primed and their
amount is sufficient for the
requested routine
• Start the job again
• If the problem persists call
Service
L M S 503.000.00016
Could not schedule Job
{0} {1} (Replicate: {2}
Dilution: {3}), no integral.
A needed Integral is
not available for the
requested job
• Ensure that the needed
Integral is onboard, online,
with enough remaning
determinations and volume
• Start the job again
• If the problem persists call
Service
L M S 503.000.00017
Scheduled Starter Prime
Job for cycle {0} JobId
{1}.
Only information - L 503.000.00018
No jobs could be
scheduled for start.
Only information - L 503.000.00019
Calibration Data
incorrect.
- • Reload the Integral again
• If the problem persists call
Service
L M 503.000.00020
A needed Dilution
Sequence was not found.
Schedule aborted.
- • Call Service L M S 503.000.00021
Message Description Action Effect Event ID
8. Troubleshooting and error messages
Page 8-82 LIAISON
®
XS - Instruction for use Rev. H
Could not schedule Job
{0} {1} (Replicate: {2}
Dilution: {3}), no ancillary.
A needed Ancillary is
not available for the
requested job
• Ensure that the needed
Ancillary is onboard, online,
with enough remaning
volume
• Start the job again
• If the problem persists call
Service
L M S 503.000.00026
Could not schedule Job
{0} {1} (Replicate: {2}
Dilution: {3}), reagent {4}
depleted.
A needed reagent is
not sufficient for the
requested job
• Ensure that the needed
reagent is onboard, online,
with enough remaning
volume
• Start the job again
• If the problem persists call
Service
L M S 503.000.00027
Could not schedule Job
{0} {1} (Replicate: {2}
Dilution: {3}), no Ancillary
for Mitigation available.
- • Load the needed ancillary
as per product IFU
• If the problem persists, call
Service
L M S 503.000.00028
Needed Control {0} not
available.
- • Load required control
Sample and ensure to run it
as per product Instruction
For Use
L M S 503.000.00030
Prime failed. Only information - L 503.000.00031
Scheduled Job {0} {1} for
Cycle {2} with JobId {3}
(Replicate: {4}, Dilution:
{5}, Finish {6}, Integral
Lane {7}, agitiation time
insufficient).
The agitation time for
the Integral is not
sufficient
• Check the product
Instruction For Use about
resuspension of magnetic
particles
L M S 503.000.00041
Three times in a row
DarkCount Exceeds
Envelop.
An error in the Reader
occurred
• Call Service L M S 503.000.00062
Three times in a row
DarkCount out of Range.
An error in the Reader
occurred
• Call Service L M S 503.000.00063
Rerun Rule {0} did not
create test {1} for {2}
because dilution factor
{3} is not defined in the
assay.
Only information - L 503.000.00067
Rerun Rule {0} did not
create test {1} because
sample {2} has been
unloaded.
Only information - L 503.000.00068
Flagged Result {0} {1}
with 'caused rerun'.
Only information - L 503.000.00069
Result {0} {1} flagged
with QC Above
Manufacturer Range.
- - L M 503.000.00070
Message Description Action Effect Event ID
8. Troubleshooting and error messages
LIAISON
®
XS - Instruction for use Rev. H Page 8-83
Result {0} {1} flagged
with QC Below
Manufacturer Range.
- - L M 503.000.00071
Could not recalculated
Result {0} {1}, undo
changes.
Only information - L M S 503.000.00082
Abort Job {0} {1} {2} {3}
for Cycle {4} JobId {5} on
SW Start or during
Initialization.
The system aborted
the involved job
because of a previous
issue (e.g. because the
SW unexpectedly
close)
• Start again the aborted job
• If the problems persists call
Service
L M S 503.001.00001
An internal error
occurred
- • Call Service L M S 503.001.00002
Aborted Job {0} {1} {2}
{3} for Cycle {4} JobId {5}
due to darkcount
subtraction.
The system aborted
the involved job
because of the
measured signal was
too low
• Start again the aborted job
• If the problems persists call
Service
L M S 503.001.00003
Aborted Job {0} {1} {2}
{3} for Cycle {4} JobId {5}
due to unexpected
Result Cycle.
The system aborted
the involved job
because of a
scheduling error
• Start again the aborted job
• If the problems persists call
Service
L M S 503.001.00004
Aborted Job {0} {1} {2}
{3} for Cycle {4} JobId {5}
due to Overdilution.
The system aborted
the involved job
because the obtained
diluted result is below
the Overdilution
threshold
• Start again the aborted job
• If the problems persists call
Service
L M S 503.001.00005
Aborted Job {0} {1} {2}
{3} for Cycle {4} JobId {5}
due to not plausible
Aspiration.
An error was detected
during the aspiration of
the involved test
• Call Service L M S 503.001.00006
Aborted Job {0} {1} {2}
{3} for Cycle {4} JobId {5}
due to starter prime not
performed.
The system aborted
the involved job
because it was not able
to successfully perform
the needed automatic
prime Cuvette
• Start again the aborted job
• If the problems persists call
Service
L M S 503.001.00007
Aborted Job {0} {1} {2}
{3} for Cycle {4} JobId {5}
due to mitigation not
performed.
The system aborted
the involved job
because it was not able
to successfully perform
the needed mitigation
• Start again the aborted job
• If the problems persists call
Service
L M S 503.001.00008
Message Description Action Effect Event ID
8. Troubleshooting and error messages
Page 8-84 LIAISON
®
XS - Instruction for use Rev. H
Aborted Job {0} {1} {2}
{3} for Cycle {4} JobId {5}
due to divided by zero.
The system aborted
the involved job
because of a
mathematical error
occurred during result
calculation
• Start again the aborted job
• If the problems persists call
Service
L M S 503.001.00009
Aborted Job {0} {1} {2}
{3} for Cycle {4} JobId {5}
due to math error.
The system aborted
the involved job
because of a
mathematical error
occurred during result
calculation
• Start again the aborted job
• If the problem persists call
Service
L M S 503.001.00010
Aborted Job {0} {1} {2}
{3} for Cycle {4} JobId {5}
due to sent too late.
The system aborted
the involved job
because it was sent too
late to instrument
• Start again the aborted job
• If the problem persists call
Service
L M S 503.001.00011
Aborted Job {0} {1} {2}
{3} due to starter lot
switch.
The system aborted
the involved job
because it is no longer
possible to obtain a
result with the same lot
of Starter
• Start again the aborted job
• If the problem persists call
Service
L M S 503.001.00020
Aborted Job {0} {1} {2}
{3} for Cycle {4} JobId {5}
due to Reagent Pressure
Error during pipetting.
- • Restart the job
• If problem persists call
Service
L M S 503.001.00021
Aborted Job {0} {1} {2}
{3} for Cycle {4} JobId {5}
due to Sample Integrity
Error.
An error occurred
during the aspiration of
the Sample
• Ensure the tube contains
the needed amount of
Sample
• Load the Sample tube in
the appropriate Rack
• Restart the job
• If the problem persists call
Service
L M S 503.001.00022
Aborted Job {0} {1} {2}
{3} for Cycle {4} JobId {5}
due to clot detected in
the sample probe
The system aborted
the involved job
because a clot was
detected during the
Sample aspiration
• Ensure the tube contains
the needed amount of
Sample
• Check Sample integrity
• Load the Sample tube in
the appropriate Rack
• Restart the job
• If the problems persist call
Service
L M S 503.001.00023
Aborted Job {0} {1} {2}
{3} for Cycle {4} JobId {5}
due to missing System
Liquid.
The system was not
able to detect the
System Liquid while
processing the
involved test
• Ensure that the System
Liquid tank is loaded,
recognized and primed
• Restart the job
• If the problem persists call
Service
L M S 503.001.00024
Message Description Action Effect Event ID
8. Troubleshooting and error messages
LIAISON
®
XS - Instruction for use Rev. H Page 8-85
Aborted Job {0} {1} {2}
{3} for Cycle {4} JobId {5}
due to missing Cuvette.
The system aborted
the involved job
because not all the
expected Cuvettes
were available
• Ensure the needed
Cuvettes are available and
assigned on the system
• Start again the aborted job
• If the problem persists call
Service
L M S 503.001.00025
Aborted Job {0} {1} {2}
{3} for Cycle {4} JobId {5}
due to missing
Disposable Tip.
The system aborted
the involved job
because not all the
expected Tips were
available
• Ensure the needed Tips are
available and assigned on
the system
• Start again the aborted job
• If the problem persists call
Service
L M S 503.001.00026
Aborted Job {0} {1} {2}
{3} for Cycle {4} JobId {5}
due to Tip Pickup Failure.
The Probe was not
able to pickup a Tip or
to recognize that a Tip
was picked up
• Check the assignment of
the Tips on the SW
• Restart the job
• If the problem persists call
Service
L M S 503.001.00027
Aborted Job {0} {1} {2}
{3} for Cycle {4} JobId {5}
due to missing Starter.
The system aborted
the involved job
because it was not
possible to dispense
the needed Starter
shots;
Possible reasons:
- the system detected
a problem during
Starter aspiration;
- the Starter bottle was
unexpectedly detected
as removed;
- the Starter RF-Tag
contains wrong data
• Ensure the Starter bottle
are loaded and primed
• Check liquid integrity
• In case the reagent was set
offline reset the LLD
• Start again the aborted job
• If the problem persists call
Service
L M S 503.001.00028
Aborted Job {0} {1} {2}
{3} for Cycle {4} JobId {5}
due to missing Wash
Buffer or System Liquid.
The system was not
able to detect the Wash
Buffer or System Liquid
while processing the
involved test
• Ensure that the Wash
Buffer and System Liquid
tanks are loaded
• Recognized and primed
• Restart the job
• If the problem persists call
Service
L M S 503.001.00029
Aborted Job {0} {1} {2}
{3} for Cycle {4} JobId {5}
due to Washer Aspiration
Error at Port {6}.
The Washer aspiration
sensors detected
anomalies during the
aspiration of the
dispensed Wash Buffer
• Restart the job
• If the problem often occurs
perform the dedicated
maintenance tasks
• If the problem persists call
Service
L M S 503.001.00030
Message Description Action Effect Event ID
8. Troubleshooting and error messages
Page 8-86 LIAISON
®
XS - Instruction for use Rev. H
Aborted Job {0} {1} {2}
{3} for Cycle {4} JobId {5}
due to not enough or no
liquid found in sample
tube.
An error occurred
during the aspiration of
the Sample or the
Sample was not
available for the
programmed aspiration
• Ensure the tube contains
the needed amount of
Sample
• Check Sample integrity
• Load the Sample tube in
the appropriate Rack
• Restart the job
• If the problem persists call
Service
L M S 503.001.00031
Aborted Job {0} {1} {2}
{3} for Cycle {4} JobId {5}
due to missing Sample.
An error occurred
during the aspiration of
the Sample or the
Sample was not
available for the
programmed aspiration
• Ensure the tube contains
the needed amount of
Sample
• Check Sample integrity
• Load the Sample tube in
the appropriate Rack
• Restart the job
• If the problem persists call
Service
L M S 503.001.00032
Aborted Job {0} {1} {2}
{3} for Cycle {4} JobId {5}
due to not enough or no
reagent found in the
Integral vial {6}.
An error occurred
during the aspiration of
the reagent or the
Integral was not
available for the
programmed aspiration
• Ensure the needed amount
of reagent is available on
the system
• Check liquid integrity
• In case the reagent was set
offline reset the LLD
• Start again the aborted job
• If the problem persists call
Service
L M S 503.001.00033
Aborted Job {0} {1} {2}
{3} for Cycle {4} JobId {5}
due to missing Reagent
{6}.
An error occurred
during the aspiration of
the reagent or the
Integral was not
available for the
programmed aspiration
• Ensure the needed amount
of reagent is available on
the system
• Check liquid integrity
• In case the reagent was set
offline reset the LLD
• Start again the aborted job
• If the problem persists call
Service
L M S 503.001.00034
Aborted Job {0} {1} {2}
{3} for Cycle {4} JobId {5}
due to not enough or no
reagent found in the
Ancillary vial {6}.
An error occurred
during the aspiration of
the Ancillary reagent or
the Ancillary was not
available for the
programmed aspiration
• Ensure the needed amount
of Ancillary reagent is
available on the system
• Check liquid integrity
• In case the reagent was set
offline unload and reload
• Start again the aborted job
• If the problem persists call
Service
L M S 503.001.00035
Message Description Action Effect Event ID
8. Troubleshooting and error messages
LIAISON
®
XS - Instruction for use Rev. H Page 8-87
Aborted Job {0} {1} {2}
{3} for Cycle {4} JobId {5}
due to missing Ancillary
{6}.
An error occurred
during the aspiration of
the Ancillary reagent or
the Ancillary was not
available for the
programmed aspiration
• Ensure the needed amount
of Ancillary reagent is
available on the system
• Check liquid integrity
• In case the reagent was set
offline unload and reload
• Start again the aborted job
• If the problem persists call
Service
L M S 503.001.00036
Aborted Job {0} {1} {2}
{3} for Cycle {4} JobId {5}
due to starter reagent
temperature out of range.
The starter reagent
temperature was out of
range when the job
was measured
• Wait for the temperature to
be back in range and restart
the job
• If the problem persists call
Service
L M S 503.001.00037
Aborted Job {0} {1} {2}
{3} for Cycle {4} JobId {5}
due to OLV Integrity Error
during dispense.
An error occurred
during the dispensation
of a reagent
• Restart the job
• If the problem persists call
Service
L M S 503.001.00039
Aborted Job {0} {1} {2}
{3} for Cycle {4} JobId {5}
due to Starter Dispense
Verification Check.
The Reader aspiration
sensor detected
anomalies during the
aspiration of the
dispensed Starters
• Restart the job
• If the problem often occurs
perform the dedicated
maintenance tasks
• If the problem persists call
Service
L M S 503.001.00040
Aborted Job {0} {1} {2}
because calibrator can
not be scheduled and its
calibration was already
started.
Rescheduling error
occured
• Restart the job
• If the problem persists call
Service
L M S 503.001.00041
Aborted Job {0} {1} {2}
{3} for Cycle {4} JobId {5}
due to user request.
- - L M S 503.001.00042
Aborted Job {0} {1} {2}
{3} for Cycle {4} JobId {5}
due to OLV Integrity Error
at Integral Lane {6}
Position {7}.
An error occurred
during the aspiration of
a reagent from the
Integral
• Check the Integral reagent
integrity (e.g. no foam,
enough volume)
• Restart the job
• If the problem persists call
Service
L M S 503.001.00043
Aborted Job {0} {1} {2}
{3} for Cycle {4} JobId {5}
due to OLV Integrity Error
at Ancillary Position {6}.
An error occurred
during the aspiration of
the Ancillary reagent
• Check Ancillary reagent
integrity (e.g. no foam,
enough volume)
• Restart the job
• If the problem persists call
Service
L M S 503.001.00044
Aborted Job {0} {1} {2}
{3} for Cycle {4} JobId {5}
due to
DarkCountOutOfRange.
The system aborted
the involved job
because the darkcount
measurement is not
valid
• Start again the aborted job
• If the problem persists call
Service
L M S 503.001.00045
Message Description Action Effect Event ID
8. Troubleshooting and error messages
Page 8-88 LIAISON
®
XS - Instruction for use Rev. H
Table 8–112: Message list, ProcessControl
Aborted Job {0} {1} {2}
{3} for Cycle {4} JobId {5}
due to DarkCount
Average Invalid.
The system aborted
the involved job
because the darkcount
measurement is not
valid
• Start again the aborted job
• If the problem persists call
Service
L M S 503.001.00046
Aborted Job {0} {1} {2}
{3} for Cycle {4} JobId {5}
due to DarkCount
Average Exceeds
Envelop.
The system aborted
the involved job
because the darkcount
measurement is not
valid
• Start again the aborted job
• If the problem persists call
Service
L M S 503.001.00047
Aborted Job {0} {1} {2}
{3} for Cycle {4} JobId {5}
due to too many Spikes
detected.
An error occurred
during the
measurement
• Restart the job
• If the problem persists call
Service
L M S 503.001.00048
Aborted Job {0} {1} {2}
{3} for Cycle {4} JobId {5}
due Pipettor Wash
failure.
- • Restart the job
• If problem persists call
Service
L M S 503.001.00049
Instrument halted due to
too many Pipettor Wash
Errors.
- • Restart the jobs
• If problem persists call
Service
L M S 503.001.00050
Aborted Job {0} {1} {2}
{3} for Cycle {4} JobId
{5}, due to event {6} {7}
- • Call Service L M S 503.001.00100
Message Description Action Effect Event ID
8. Troubleshooting and error messages
LIAISON
®
XS - Instruction for use Rev. H Page 8-89
8.57 InstrumentControl
Device ID: 0x1F6
8.57.1 Sub assemblies
Table 8–113: Sub assemblies, InstrumentControl
8.57.2 Message list
ID (dec) ID (hex) Name
0 0x00 CoordinateFileNotAvailable
Message Description Action Effect Event ID
Coordinate file could
not be loaded.
- • Replace the not working
coordinate file a working one
and teach the system again
• If problem persists call
Service
L M S 502.000.00000
An internal error
occurred
- • Call Service L M S 502.000.00001
One or more
instrument modules did
not initialize properly.
- • Initialize the system
• If the problem persists
• Switch off, restart and
initialize the system
• If the problem persists call
Service
L M S 502.000.00003
Instrument halted! - • Initialize the system
• If the problem persists, switch
off, restart and initialize the
system
• If the problem persists call
Service
L S 502.000.00004
Transparent mode
required by service
software is active.
- • Call Service L M S 502.000.00007
Incompatible firmware
version: {0}. Expected
one of the following:
{1}.
A compatibility issue
with Firmware versions
was detected.
• Call Service L M S 502.000.00008
A communication error
occurred
- • Switch off, restart and
initialize the system
• If the problem persists call
Service
L M S 502.000.00009
A communication error
occurred
- • Switch off, restart and
initialize the system
• If the problem persists call
Service
L M S 502.000.00010
8. Troubleshooting and error messages
Page 8-90 LIAISON
®
XS - Instruction for use Rev. H
A communication error
occurred
- • Switch off, restart and
initialize the system
• If the problem persists call
Service
L M S 502.000.00011
Dynamic coordinates
could not be
downloaded to the
system.
- • Initialize the system
• If the problem persists, switch
off, restart and initialize the
system
• If the problem persists call
Service
L M S 502.000.00012
Too late to transmit Job
with JobID {0}.
A processing error was
detected
• Restart the job
• If the problem often occurs
call Service
L M S 502.000.00013
A scheduling error
occurred
- • Call Service L M S 502.000.00014
The reported incubator
ring status does not
match the internal
status. Incubator ring
will be cleared and
reloaded.
- • If the problem persists call
Service
L M S 502.000.00015
An internal error
occurred
- • Restart the test
• If problem persists call
Service
L M S 502.000.00016
Resource state has
changed: {0} changed
to {1}.
Only information - L 502.000.00017
The ring is completely
cleared as status
Ready was not entered
after Running or
Maintenance.
- • If the problem persists, call
Service
L M S 502.000.00018
The import was
aborted because the
instrument is in
Running.
- • Try the import again when the
system is not running
L S 502.000.00020
System Liquid not
primed because last
Pipettor Wash/Prime
failed.
Only information • Restart the resume
• If problem persists call
Service
L 502.000.00021
Pipettor wash failed. Only information • Restart the job
• If problem persists call
Service
L 502.000.00023
A fatal error occurred
on Instrument.
(EventID: {0})
- • If the problem persists call
Service
L M S 502.000.00050
An internal error
occurred
- • If the problem persists call
Service
L M S 502.000.00051
Message Description Action Effect Event ID
8. Troubleshooting and error messages
LIAISON
®
XS - Instruction for use Rev. H Page 8-91
Table 8–114: Message list, InstrumentControl
8.58 Database
Device ID: 0x1F5
8.58.1 Sub assemblies
Table 8–115: Sub assemblies, Database
8.58.2 Message list
Table 8–116: Message list, Database
FSE Mode disabled. Only information - L M 502.000.00053
FSE Mode enabled. Only information - L M 502.000.00054
Message Description Action Effect Event ID
ID (dec) ID (hex) Name
0 0x00 RepositoryException
Message Description Action Effect Event ID
General database
error.
- • Call Service L M S 501.000.00000
Failed to connect to the
database.
- • Call Service L M S 501.000.00001
No database available
or connection not
possible.
- • Call Service L M S 501.000.00003
The database is not
compatible with the
installed SW version
- • Call Service L M S 501.000.00004
A cycle mismatch
occured. Backup
Cycle: {0} Database
Cycle {1} COP Cycle
{2} new Cycle {3}
Only information - L M 501.000.00010
Database check error
occurred: {0}. Please
call Customer Service.
- - L M 501.000.00012
8. Troubleshooting and error messages
Page 8-92 LIAISON
®
XS - Instruction for use Rev. H
8.59 ComProtocol
Device ID: 0x1F4
8.59.1 Sub assemblies
Table 8–117: Sub assemblies, ComProtocol
8.59.2 Message list
Table 8–118: Message list, ComProtocol
ID (dec) ID (hex) Name
0 0x00 ComProtocolException
Message Description Action Effect Event ID
A communication error
occurred
- • Switch off, restart and
initialize the system
• If the problem persists call
Service
L M S 500.000.00039
8. Troubleshooting and error messages
LIAISON
®
XS - Instruction for use Rev. H Page 8-93
8.60 Application
Device ID: 0x1F4
8.60.1 Sub assemblies
Table 8–119: Sub assemblies, Application
8.60.2 Message list
ID (dec) ID (hex) Name
00x00Started
999 0x3E7 ResearchAndDevelopment
Exception
Message Description Action Effect Event ID
Application started.
Version (product/file):
{0}/{1}
Only information - L 500.000.00000
Application ended. Only information - L 500.000.00001
User {0} logged in at
level {1}.
Only information - L 500.000.00002
User {0} logged off. Only information - L 500.000.00003
File {0} has wrong
format
- • Import the file again
• If the problem persists call
Service
L 500.000.00004
File {0} has wrong
checksum.
The file is corrupted • Import the file again
• If the problem persists retry
with a fresh copy of the
original file
• If the problem persists call
Service
L 500.000.00005
Aborted import of file
{0}.
Import was not
successfully completed
• Import the file again
• If the problem persists call
Service
L 500.000.00006
File export error. Export was not
successfully completed
• Ensure that the export path is
available (e.g. network path,
USB)
• Export the file again
• If the problem persists call
Service
L 500.000.00007
File {0} could not be
exported.
Export was not
successfully completed
• Ensure that the export path is
available (e.g. network path,
USB)
• Export the file again
• If the problem persists call
Service
L 500.000.00008
8. Troubleshooting and error messages
Page 8-94 LIAISON
®
XS - Instruction for use Rev. H
Unexpected software
error. Application must
be closed.
- • Reboot the system and start
the SW again
• If the problem persists call
Service
L M S 500.000.00009
An internal error
occurred
- • Call Service L M S 500.000.00010
An internal error
occurred
- • Call Service L M S 500.000.00011
An internal error
occurred
- • Call Service L M S 500.000.00012
A timeout has been
reached while waiting
for a response from the
instrument
The instrument did not
respond within a
reasonable time
• Check power connection
• Switch off and restart the
system
• If the problem persists call
Service
L M S 500.000.00013
The system failed to
start '{0}'
- • Switch off and restart the
system
• If the problem persists call
service
L M 500.000.00015
Assay with
Abbreviation {0}, Article
Number {1}, Name {2}
LIS alias {3} could not
be imported because of
existing Assay with
Abbreviation {4}, Article
Number {5}, LIS Alias
{7}
- • Ensure that there is not a
conflict between the current
LIS alias and the LIS alias of
the Assay to be imported
• If the problem persists call
Service
L M 500.000.00016
Assay '{0}' with article
number '{1}', name '{2}'
and LIS alias '{3}' could
not be deleted because
it is still referenced by
assay group '{4}'.
Only information • Remove the Assay reference
form the specified group and
retry to delete it
L 500.000.00017
Assay '{0}' with article
number '{1}', name '{2}'
and LIS alias '{3}' could
not be deleted because
it is still referenced by
assay profile '{4}'.
Only information • Remove the Assay reference
form the specified profile and
retry to delete it
L 500.000.00018
Assay '{0}' with article
number '{1}', name '{2}'
and LIS alias '{3}' could
not be deleted because
it is still referenced by
control definition '{4}',
lot number '{5}'.
Only information • Remove the Assay reference
form the specified control
definition and retry to delete it
L 500.000.00019
Message Description Action Effect Event ID
8. Troubleshooting and error messages
LIAISON
®
XS - Instruction for use Rev. H Page 8-95
Assay '{0}' with article
number '{1}', name '{2}'
and LIS alias '{3}' could
not be deleted because
it is still referenced by
rerun rule '{4}'.
Only information • Remove the Assay reference
form the specified rerun rule
and retry to delete it
L 500.000.00020
Assay '{0}' with article
number '{1}', name '{2}'
and LIS alias '{3}' could
not be deleted because
it is still referenced by
one or more browser
results.
Only information • Archive or delete any browser
result related to the involved
Assay and retry to delete it
L 500.000.00021
Generic sequences
import finished
successfully.
Only information - L 500.000.00022
Generic sequences
import failed.
Only information • Import the file again
• If the problem persists retry
with a fresh copy of the
original file
• If the problem persists call
Service
L 500.000.00023
Generic sequences not
loaded.
- • Call Service L 500.000.00024
Dilution sequences
import finished
successfully.
Only information - L 500.000.00025
Dilution sequences
import failed.
Only information • Import the file again
• If the problem persists retry
with a fresh copy of the
original file
• If the problem persists call
Service
L 500.000.00026
A problem occurred
during the archiving of
the old system log files
- • Ensure that the HDD space is
not too low
• If the space is too low free
some disk space
• If the problem persists call
Service
L M 500.000.00027
System Settings import
finished successfully.
Only information - L 500.000.00028
System Settings import
failed.
- • Import the file again
• If the problem persists retry
with a fresh copy of the
original file
• If the problem persists call
Service
L M S 500.000.00029
Message Description Action Effect Event ID
8. Troubleshooting and error messages
Page 8-96 LIAISON
®
XS - Instruction for use Rev. H
System Settings Export
finished successfully.
Only information - L 500.000.00030
System Settings Export
failed.
Only information • Ensure that the export path is
available (e.g. network path,
USB)
• Export the file again
• If the problem persists call
Service
L 500.000.00031
Could not delete
calibration with
Calibration Id {0}. The
calibration is still
referenced by at least
one result.
Only information • Archive or delete any
calibrator browser result
related to the involved
calibration and retry to delete
it
L M 500.000.00032
Assay deletion failed.
The following assays
are still referenced by
other assays: {0}
Only information • Ensure that all fathers of
combi families are deleted
before their combi sons
L 500.000.00040
Online Help
initialization failed.
Could not link the
software views with the
Online Help chapters.
• Try the import again when the
system is not running
• If the problem persists call
Service
L M S 500.000.00041
Deleted reference to
unknown Assay '{0}' in
imported group '{1}'.
- - L 500.000.00042
Group '{0}' has been
overwritten by import.
Only information - L 500.000.00043
Patient database could
not be opened and has
been recreated.
Only information - L 500.000.00044
Removed Rerun Rule
'{0}' with unknown
Assay(s) '{1}' from
import.
Only information - L 500.000.00045
Rerun Rule '{0}' has
been overwritten by
import.
Only information - L 500.000.00046
At least one combi
family was not archived
due to a result not in
Done or Failed status.
Only information - L 500.000.00050
The {0} manuals have
been successfully
downloaded.
Only information - L 500.000.00051
Message Description Action Effect Event ID
8. Troubleshooting and error messages
LIAISON
®
XS - Instruction for use Rev. H Page 8-97
The {0} instrument
package for the
consumable with article
no. {1} and lot no. {2}
has been successfully
downloaded.
Only information - L 500.000.00052
The {0} instrument
package for the assay
with article no. {1} and
lot no. {2} has been
successfully
downloaded.
Only information - L 500.000.00053
The {0} instrument
package for the control
with control name {1}
and control lot {2} has
been successfully
downloaded.
Only information - L 500.000.00054
The {0} manuals could
not be downloaded.
Only information - L 500.000.00055
The {0} instrument
package for the
consumable with article
no. {1} and lot no. {2}
could not be
downloaded.
Only information - L 500.000.00056
The {0} instrument
package for the assay
with article no. {1} and
lot no. {2} could not be
downloaded.
Only information - L 500.000.00057
The {0} instrument
package for the control
with control name {1}
and control lot {2} could
not be downloaded.
Only information - L 500.000.00058
All instrument
packages were
successfully acquired.
Only information - L 500.000.00059
One or more
instrument packages
could not be acquired.
Only information • Try to download and acquire
the instrument package again
• If the problem persists, call
Service
L 500.000.00060
Message Description Action Effect Event ID
8. Troubleshooting and error messages
Page 8-98 LIAISON
®
XS - Instruction for use Rev. H
Table 8–120: Message list, Application
Expected Country
Code {0} but got {1}.
- • In case the file was
downloaded from DiaSorin
online repository, ensure that
the country selected for the
package matches with the
country set in the Main SW
• If the problem persists, call
Service
L 500.000.00061
The instrument
package to be imported
has a wrong structure.
- • Try to download and acquire
the instrument package again
• if the problem persists, call
Service
L 500.000.00062
The connection to the
cloud is currently
interrupted. The
download will start
once the connection is
established.
- • Try to download package
again
• If the problem persists, check
the network cable
• If the problem persists,
contact the Laboratory IT to
check that the network policy
have been correctly set to
allow the connection for the
IoT services
• If the problem persists, call
Service
L 500.000.00063
{0} replicates found in
the Results All page.
Please, archive or
delete Results to
maintain proper
software performance.
- - L M 500.000.00100
Software has to close.
{0}
- • Call Service L M S 500.999.99999
Message Description Action Effect Event ID
9. Technical data
LIAISON
®
XS - Instruction for use Rev. H Page 9-1
9 Technical data
9.1 Power requirements
Table 9–1: Power requirements
9.2 Laser barcode scanner
9.2.1 System laser barcode scanner
Table 9–2: Laser barcode scanner
Specification
Values are achieved under optimal conditions and can vary depending on environmental
conditions, instrument status and processing conditions.
Voltage: 100 V - 240 V ± 10 %
Frequency: 50 - 60 Hz
Power consumption: mean: 200 W (peak: 300 W): 683 BTU/h
(peak: 1024 BTU/h)
Input current range: 4 - 1.7 A
Fuse: primary 250 VAC, T4AH
Class: Class 2 laser product
Available bar-codes: • Code 128/EAN 128 (set as default)
• Codabar (set as default)
• Code 39 (set as default)
• 2/5 Interleaved (to be set)
Please check with local service support the enabling
status of the barcode types of interest.
Barcode types not strictly compliant with this list are not
allowed and must not be used on the system.
Barcodes quality shall match category A or B (according
to ANSI X3.182 standard) or category 4 and 3 (according
to ISO/IEC 15416 standard). In addition:
• 0.167 mm ≤ width ≤ 0.5 mm
• 1:2.5 ≤ ratio ≤ 1:3 (if 0.167 mm ≤ width < 0.2 mm) or
• 1:2 ≤ ratio ≤ 1:3 (if 0.2 mm ≤ width ≤ 0.5 mm)
Maximal output radiation: 85 µW
Maximal pulse duration: 112 µs
Emitted wave length: 660 nm
Standards: IEC 60825-1:2007;
IEC 60825-1:2014, except otherwise noted
Reading distance: 45 - 270 mm
9. Technical data
Page 9-2 LIAISON
®
XS - Instruction for use Rev. H
9.2.2 Handheld barcode reader
Please, refer to handheld barcode reader user manual for technical information.
9.3 Computer and connections
Table 9–3: Computer connections
Table 9–4: Software
9.4 Dimensions and weight
Table 9–5: Dimensions and Weight (including covers)
Panel PC
Processor type:
Intel
®
(or compatible)
Touch screen type: Projected Capacitive Touch Panel
User Access Panel (right hand side of the instrument, see chapter 4.1.7)
Ports: • 1 x RJ-45
• 4 x USB 2.0
Software
Operating system:
Microsoft
®
Windows
®
10 IoT Enterprise (64 bit)
Weight Width Depth Height
Instrument: 137 kg
(302 lb)
1280 mm
(50 in)
750 mm
(29.5 in)
720 mm
(28 in)
9. Technical data
LIAISON
®
XS - Instruction for use Rev. H Page 9-3
9.5 System clearance
Figure 9–1: System clearance, front view
Figure 9–2: System clearance, side view
9. Technical data
Page 9-4 LIAISON
®
XS - Instruction for use Rev. H
9.6 Environmental conditions
The following table shows the range of conditions needed to run the system safely.
Table 9–6: Environmental conditions
9.7 Noise emission
Table 9–7: Noise emission
9.8 Temperature Ranges
Table 9–8: Temperature Ranges
Environmental Conditions: The system is made for Indoor use only.
Temperature: Operating: 15 °C to 32 °C (59 °F to 89.6 °F)
Storage: 5 °C to 40 °C (41 °F to 104 °F)
Transport: -20 °C to 60 °C (-4 °F to 140 °F)
(for no more than 48 hrs)
Humidity: Operating: 20 - 85 % non-condensing
Storage: 20 - 85 % non-condensing
Transport: 10 - 95 % non-condensing
Pollution Degree: 2 (EN 61010-1:2001)
Installation Class: 2 (EN 61010-1:2001)
Limit Class: Class A
(For industrial use. Domestic use restricted)
Sunlight: No direct sunlight.
May mislead optical sensors and affect performance.
Altitude: Up to 3000 m (9843 ft) above mean sea level.
Dust: No excessive dust.
Max value measured at normal user position, with closed cover hood at 1 m distance to
enclosure (39.4 in) is 65 dB(A).
Ambient Temperature: 15 °C - 32 °C (59 °F - 89.6 °F)
Incubating Temperature: 35 °C - 37 °C (95 °F - 98.6 °F), in liquid
Temperature inside the
system:
Ambient temperature ±5 °C (±9 °F)
Reagent Loading Bay
Temperature:
11 °C - 15 °C (51.8 °F - 59 °F)
Sample Loading Bay
Temperature:
Ambient temperature ±3 °C (±5.4 °F)
Starter tubes Temperature: 34 °C - 36 °C (93.2 °F - 96.8 °F)
9. Technical data
LIAISON
®
XS - Instruction for use Rev. H Page 9-5
9.9 Water quality
The water to be used for the dilution and reconstitution of the Liaison XS reagents and
consumables should comply with the definition of “Instrument Feed Water”, according to
CLSI standard “Preparation and Testing of Reagent Water in the Clinical Laboratory;
Approved Guideline – Fourth Edition”.
In particular, the water shall contain the following characteristics:
• pH: 5.0 – 8.0
• conductivity: < 2 µS/cm
• resistivity: > 0.5 M Ohm-cm
• TOC: < 500 ppb
• SiO2: < 1.0 ppm
• Bacteria: < 10 CFU/mL
9. Technical data
Page 9-6 LIAISON
®
XS - Instruction for use Rev. H
10. Disinfection procedure
LIAISON
®
XS - Instruction for use Rev. H Page 10-1
10 Disinfection procedure
10.1 Introduction
Purpose of this procedure is to provide instructions to the users to disinfect the analyzer,
using disinfectant alcoholic solutions or sodium hypochlorite solution at 0.5 - 0.9 % active
chlorine.
The following instructions apply to LIAISON
®
XS.
The scope of the disinfectant procedure is to address decontamination of the instrument
with specific reference to:
• Surfaces or components where the disinfection procedure could be applied.
• Disinfection products to be used.
• Particular directions related to the procedure and the contact time for the
disinfection products.
Therefore, the procedures are intended as an “extraordinary measure” suggested in case
of specific situations (e.g. safety concerns associated to spillage of potentially
biohazardous material or any other specific requirements).
This means that the disinfection procedure is not required to ensure the correct functionality
of the instrument (which instead is ensured by the regular application of periodical
maintenance procedures, prescribed in the chapter 7).
The present procedure describes operations to be executed to make parts of the
instrument, which are accessible to the user under standard operative conditions,
reasonably safe against possible transmission of infectious diseases, being aware that
treatment based on chemical disinfectant does not ensure complete inactivation of all
pathogens.
Sodium hypochlorite solution at 0.5 - 0.9 % active chlorine or alcoholic solutions with
bactericide and virucide high activity shall be used for the scope. Be sure the virucide/
bactericide agents used are active also against non-enveloped viruses such as
(e.g. norovirus, rotavirus, adenovirus, poliovirus).
Disinfection with sodium hypochlorite solution at 0.5 % of active chlorine requires contact
time of at least 10 minutes; for alcohol based disinfectants, the user must refer to the
contact time recommended by the manufacturer for the specific disinfectant.
Activities herein described must be performed by personnel specifically trained in good
laboratory practices, analyzer use and wearing personal protective equipment to prevent
transmission of infectious diseases by contact and droplets.
Fully comply with the present procedure in order to avoid instrument damage or
malfunction.
10. Disinfection procedure
Page 10-2 LIAISON
®
XS - Instruction for use Rev. H
10.2 Hazards
Please refer to paragraph 1.6 of present manual, for a detailed and complete description of
potential hazards involved in instrument use and maintenance.
10.2.1 Biological Hazards
Performing the following activities may expose the user to potentially infectious materials:
• Handling samples, reagents, calibrators, and controls.
• Cleaning spills.
• Handling and disposing of waste.
• Performing maintenance procedures.
• Performing cleaning or disinfection procedures.
The following information will help the user in minimizing the impact of this exposure.
User should consider all clinical samples, reagents, calibrators, controls, and used reaction
vessels and consumables (e.g. tips, cuvettes) that contain human-sourced material as
potentially infectious. User should consider all system surfaces or components that have
come in contact with human-sourced material as potentially infectious. No known test
method can offer complete assurance that products derived from human sourced material
will not transmit infection. Therefore, all products derived from human-sourced materials
and system components exposed to human-sourced materials should be considered
potentially infectious.
Precautions include, but are not limited to the following:
• Observe local and national provisions, legislation and laboratory regulations.
• Use appropriate resistant protective gloves suitable for biological risk.
• Use an appropriate lab coat or other protective clothing.
• Use appropriate eye protection.
• Avoid contact between skin/mucous membrane and samples/test reagents or parts
of the instrument.
• Do not pipette by mouth.
• Do not eat, drink, smoke, apply cosmetics or handle contact lenses when handling
human-sourced material or contaminated system components
• Clean and disinfect the system immediately if potentially infectious material has
been spilled.
• Any reagent spills should be washed with a chemical use sodium hypochlorite
solution with 0.5 % - 0.9 % active chlorine (e.g. dilution 1:10 of a solution at 5 %
active chlorine) and all waste should be disposed of as though potentially
infectious.
• All samples, biological reagents and materials used in the assays must be
considered potentially able to transmit infectious agents. They should therefore be
decontaminated and disposed of in accordance with the prevailing regulations and
guidelines of the agencies holding jurisdiction over the laboratory, and the
regulations of each Country.
• Liquid waste must be decontaminated with a chemical use sodium hypochlorite
solution with 0.1 % active chlorine (e.g. dilution 1:50 of a solution at 5 % active
chlorine) for at least 30 minutes.
• Do not use broken or chipped tubes or bottles.
• Observe the instructions in the package inserts for correct use of the reagents.
10. Disinfection procedure
LIAISON
®
XS - Instruction for use Rev. H Page 10-3
10.2.2 Chemical Hazards
User may be exposed to hazardous chemicals when handling reagents, calibrators and
controls.
Exposure to hazardous chemicals is minimized by following instructions provided in the
assay-specific documentation (such as a package insert) and on product-specific labels,
and product-specific MSDS (Material Safety Data Sheets).
In general, observe the following precautions when handling chemicals:
• Consult MSDS for safe use instructions and precautions.
• Avoid contact with skin and eyes. If contact with material is anticipated, wear
impervious gloves, protective eye wear, and clothing.
• Maintain good housekeeping. Do not eat, drink, or store food and beverages in
areas where chemicals are used.
• Seek medical attention if irritation or signs of toxicity occur after exposure.
10.2.3 Spill clean-up
Clean spills in accordance with established biosafety practices and follow instructions in the
MSDS (Material Safety Data Sheets). In general, safe work practices for cleaning spills
include:
• Wear appropriate personal protective equipment, such as gloves, eye wear and lab
coat.
• Absorb the spill with absorbent material.
• Wipe and clean the area with an appropriate disinfectant such as a chemical use
sodium hypochlorite solution with 0.5 % - 0.9 % active chlorine (e.g. dilution 1:10 of
a solution at 5 % active chlorine) or disinfectant alcoholic based solution at
recommended alcohol concentration of 60-90 %.
Risk of infection!
All internal parts of the system, that are not defined as user interfaces and for which
specific procedures are described, must be treated as being potentially infectious.
Improper handling of infectious parts can cause skin irritations, illnesses and possibly
death.
Disposal of Infectious Waste
Potential infectious material and all parts that may come in contact with potential
infectious material must be disposed of according to the local and national provisions,
legislation and laboratory procedures.
Handling of Disinfectant Products
• Disinfectant products may be harmful. Read all instructions provided with the
disinfectant products before use.
• Do not mix sodium hypochlorite solution (e.g. bleach) with alcohol based disinfectants.
• Observe the proper dilution of chemicals, as stated by the SW (Software)
In case commercial sodium hypochlorite solutions are used (e.g. bleach), avoid
formulations featuring any fragrance, surfactant, other oxidizer or additive.
10. Disinfection procedure
Page 10-4 LIAISON
®
XS - Instruction for use Rev. H
10.2.4 Waste handling and disposal
Each facility is responsible for labeling all waste tanks and characterizing its waste stream
to ensure waste is disposed of in accordance with the appropriate local regulations.
See the manufacturer's assay-specific documentation (such as a package insert or reagent
application sheet), the product-specific label, or the product-specific MSDS (Material Safety
Data Sheet).
10.3 Alcoholic solution specifications
Alcohol based solutions used shall be defined by the manufacturer as high activity
bactericide and virucide. Be sure the virucide/bactericide agents are active also against
non-enveloped viruses such as e.g. norovirus, rotavirus, adenovirus, and poliovirus.
An alcohol concentration of 60-90 % is generally recommended. Refer to manufacturer’s
instruction for safety handling and other technical information.
10.4 Preparation of sodium hypochlorite solution
Instructions to prepare 1 Liter of sodium hypochlorite solution at 0.5-0.9 % of active
chlorine:
1. Fill a graduate cylinder with 0.9 L of water;
2. Add 100 mL of a sodium hypochlorite solution (e.g. bleach) with a 5 - 9 %
content of active chlorine. In case the available sodium hypochlorite should have
a different titer, please adjust the dilution accordingly;
3. Briskly mix.
10. Disinfection procedure
LIAISON
®
XS - Instruction for use Rev. H Page 10-5
10.5 Disinfection procedure Task
Some parts of the instrument shall be cleaned during the execution of the Disinfection
Procedure, as indicated by a dedicated pop-up that appears during the execution of the
task:
1. Quit the Main UI;
2. Switch off the instrument and disconnect it from the main supply.
3. Open the sample area flap and extract the available sample racks; remove the
sample tubes.
4. Open the reagent area flaps and extract the reagent integrals, store them
according to the corresponding IFUs.
5. Open the top cover and move the right and left arms to a position easy to
access.
6. Wipe with a tissue saturated with an alcoholic/disinfectant solution the following
parts/surfaces:
• Sample racks.
• Left arm adapter (wipe downward)
• Sample area interior.
• Reagent area cover.
• Incubator cover.
• Monitor.
7. Repeat step 6 twice.
8. Wipe with a tissue soaked with a sodium hypochlorite solution at 0.5 - 0.9 %
active chlorine the following parts/surfaces:
• Right arm needle.
• Tip drop off mechanism, placed on the lower area of the sample arm.
• Pipettor wash station (upper rim).
9. Repeat step 8 twice.
10. Wipe all previous treated surfaces with a a tissue soaked with DI water
.
Before starting the Disinfection Procedure task, 1.5 L of Cleaning Solution shall be
prepared according to chapter 7.3.
Disinfection
Procedure Task
1. Ensure that the instrument is not in “running” or “maintenance” status before
starting the Disinfection Procedure;
2. Click on the Maintenance main category and select the Disinfection
Procedure Task;
3. Tap on the “Perform” Button to start the Disinfection Procedure;
4. Follow the instructions described in the maintenance task.
Use a new tissue for each part; dispose of used tissues as biological hazardous materials.
Use a new tissue for each part; dispose of used tissues as biological hazardous materials.
10. Disinfection procedure
Page 10-6 LIAISON
®
XS - Instruction for use Rev. H
11. Wipe all previous treated surfaces with a dry tissue.
12. Empty the liquid waste tank following the User manual instructions.
13. Wipe with a tissue saturated with a sodium hypochlorite solution at 0.5 - 0.9 %
active chlorine the following parts/surfaces:
• Exterior surfaces of the tank.
• Joint connector probe and the slot for disconnected waste tubing and sensor
connector.
• Waste basin.
14. Repeat step 13 twice.
15. Wipe all previous treated surfaces with a a tissue soaked with DI water
.
16. Wipe all previous treated surfaces with a dry tissue.
17. Open the solid waste bin.
18. Unload the LIAISON
®
EASY Waste holded in the solid waste Bin according to
LIAISON
®
XS User Manual, paragraph 5.4.7.
19. Wipe the Solid Waste Bin internal surface with a tissue saturated with a sodium
hypochlorite solution at 0.5 - 0.9 % active chlorine.
20. Repeat step 19 twice.
21. Wipe all previous treated surfaces with a a tissue soaked with DI water
.
22. Wipe all previous treated surfaces with a dry tissue.
Use a new tissue for each part; dispose of used tissues as biological hazardous materials.
Use a new tissue for each part; dispose of used tissues as biological hazardous materials.
Use a new tissue for each part; dispose of used tissues as biological hazardous materials.
Use a new tissue for each part; dispose of used tissues as biological hazardous materials.
Use a new tissue for each part; dispose of used tissues as biological hazardous materials.
Use a new tissue for each part; dispose of used tissues as biological hazardous materials.
Use a new tissue for each part; dispose of used tissues as biological hazardous materials.
Use a new tissue for each part; dispose of used tissues as biological hazardous materials.
10. Disinfection procedure
LIAISON
®
XS - Instruction for use Rev. H Page 10-7
23. If the decontamination procedure has been completed, reconnect the instrument
to the main supply and switch it on.
Use a new tissue for each part; dispose of used tissues as biological hazardous materials.
10. Disinfection procedure
Page 10-8 LIAISON
®
XS - Instruction for use Rev. H
11. Country Specific Notes
LIAISON
®
XS - Instruction for use Rev. H Page 11-1
11 Country Specific Notes
11.1 USA
For Customer Service in US and Canada call toll free: 1-800-328-1482
Table in chapter 1.5.3 is integrated by the following:
Symbol Title Standard
Reference
number
Description
Manufacturer
ISO 15223-1: Medical
Devices – Symbols to be
used with medical device
labels, labelling and
information to be supplied
5.1.1
Indicates the medical
device manufacturer, as
defined in EU Directives
90/385/EEC, 93/42/EEC
and EU Regulation
2017/746/EU
Date of
manufacture
ISO 15223-1: Medical
Devices – Symbols to be
used with medical device
labels, labelling and
information to be supplied
5.1.3
Indicates the date when
the medical device was
manufactured.
In vitro
diagnostic
medical
device
ISO 15223-1: Medical
Devices – Symbols to be
used with medical device
labels, labeling and
information to be supplied
5.5.1
Indicates a medical
device that is intended
to be used as in vitro
diagnostic medical
device.
Catalogue
number
ISO 15223-1: Medical
Devices – Symbols to be
used with medical device
labels, labeling and
information to be supplied
5.1.6
Indicates the
manufacturer’s
catalogue number so
that the medical device
can be identified.
Serial number
ISO 15223-1: Medical
Devices – Symbols to be
used with medical device
labels, labeling and
information to be supplied
5.1.7
Indicates the
manufacturer’s serial
number so that a
specific medical device
can be identified
Consult
electronic
instructions
for use
ISO 15223-1: Medical
Devices – Symbols to be
used with medical device
labels, labeling and
information to be supplied
5.4.3
Indicates the need for
the user to consult the
instructions for use
11. Country Specific Notes
Page 11-2 LIAISON
®
XS - Instruction for use Rev. H
11.1.1 EMC Compliance
The LIAISON
®
XS Analyzer has been tested according to the method of IEC 61326-1 and
IEC 61326-2-6 using the threshold reported in the Electromagnetic compatibility (EMC)
standard IEC 60601-1-2:2014+A1:2020 Medical electrical equipment - Part 1-2: General
requirements for basic safety and essential performance - Collateral Standard:
Electromagnetic disturbances - Requirements and tests.
The LIAISON
®
XS Analyzer is intended for use in the electromagnetic environment
specified below. The customer or the user of the LIAISON
®
XS Analyzer should assure that
it is used in such an environment.
Table 11–1: Guidance and Manufacturer's Declaration - Electromagnetic Emission
Caution
ISO 15223-1: Medical
Devices – Symbols to be
used with medical device
labels, labeling and
information to be supplied
5.4.4
Indicates the need for
the user to consult the
instructions for use for
important cautionary
information such as
warnings and
precautions that cannot,
for a variety of reason,
be presented on the
medical device itself.
Emission -tests Compliance
RF emissions CISPR 11 Group 1
RF emissions CISPR 11 Class A
Immunity Test
Compliance Level Against
IEC 60601-1-2:2014+A1:2020
Electrostatic discharge (ESD)
IEC 61000-4-2
Contact: ± 8 kV
Air: ± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV
Radiated Immunity Testing
IEC 61000-4-3
3 V/m 80-2700 MHz 1kHz 80% am
9-28 V/m 385-6000 MHz pulse mode
Electrical fast transient/burst
IEC 61000-4-4
Power Supply Lines at 100 kHz, ± 2.0 kV
Surge
IEC 61000-4-5
Line to Line: ± 1.0 kV
Line to ground: ± 2.0 kV
Conducted Immunity Testing
IEC 61000-4-6
3 V: 0.15 – 80 MHz
6V: In ISM Bands between 0.15 MHz and
80 MHz
80 % AM at 1 kHz
11. Country Specific Notes
LIAISON
®
XS - Instruction for use Rev. H Page 11-3
Table 11–2: Guidance and Manufacturer's Declaration - Electromagnetic Immunity
No essential performance has been identified, loss of clinical function will not result in any
unacceptable risk.
Use of this equipment stacked with another equipment is not allowed.
Avoid using the equipment close to another equipment. If such use is necessary, this
equipment and the other equipment should be observed to verify that they are operating
normally.
Use of cables other than those specified or provided could result in increased
electromagnetic emissions or decreased electromagnetic immunity of this equipment and
result in improper operation.
11.1.2 FCC Radio User Manual Guidance
This equipment has been tested and found to comply with the limits for a Class A digital
device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide
reasonable protection against harmful interference when the equipment is operated in a
commercial environment. This equipment generates, uses, and can radiate radio
frequency energy and, if not installed and used in accordance with the instruction manual,
may cause harmful interference to radio communications. Operation of this equipment in a
residential area is likely to cause harmful interference in which case the user will be
required to correct the interference at his own expense.
Changes or modifications not expressly approved by the party responsible for compliance
could void the user’s authority to operate the equipment.
Voltage dips
IEC 61000-4-11
0% U
T; 0,5 cycle, At 0°, 45°, 90°, 135°, 180°,
225°, 270° and 315°
0% U
T; 1 cycle and 70 % UT; 25/30 cycles
Single phase: at 0°
Voltage interruptions
IEC 61000-4-11
0% U
T; 250/300 cycle
Power frequency (60 Hz) magnetic field
IEC 61000-4-8
30 A/m at 60 Hz
Proximity to Magnetic Fields
IEC 61000-4-39
134.2 kHz and 13.56 MHz
Electromagnetic Interference (EMI)
This equipment has been tested and found to comply with the requirements of
IEC 60601-1-2 for electromagnetic compatibility. However, to help ensure optimal
performance and continued safe operation, avoid placing the device in close proximity to
sources of radio frequency (RF) emissions. These include, but are not limited to:
• Mobile phones and wireless communication devices (including 5G millimeter
wave)
• RFID readers and EAS (Electronic Article Surveillance) systems
• Wireless Power Transfer devices
• Wireless routers and Bluetooth transmitters
Industrial equipment generating strong electromagnetic fields
11. Country Specific Notes
Page 11-4 LIAISON
®
XS - Instruction for use Rev. H
11.2 Canada
Manufactured for DiaSorin Inc., 1951 Northwestern Ave, Stillwater, MN, 55082-0285 USA
For Customer Service in US and Canada call toll free: 1-800-328-1482
11.2.1 ISED Canada Radio User Manual Guidance
This device contains licence-exempt transmitter(s)/receiver(s) that comply with Innovation,
Science and Economic Development Canada’s licence-exempt RSS(s). Operation is
subject to the following two conditions:
1. This device may not cause interference.
2. This device must accept any interference, including interference that may cause
undesired operation of the device.
11.3 Brazil
Distribuído no Brasil por: DiaSorin Ltda – CNPJ 01.896.764/0004-12 – Avenida Caio
Cotrim, 1100 – C-51 – Bairro Itaqui – Itapevi – SP - SAC: 0800 77 16216
email: diasorin@diasorin.com
11.4 China
11.4.1 Introduction
This paragraph is aimed at acting as an official amendment to the LIAISON
®
XS User
Manual (Compliance with ROHS – China).
The reason of this paragraph is to ensure full compliance with Management Methods for
the Restriction of the Use of Hazardous Substances in Electrical and Electronic Products
(ROHS) - Order No. 32 of the China’s Ministry of Industry and Information Technology of
on January 21, 2016.
Producers and importers of electrical and electronic products shall, in accordance with the
national or industry standards for labelling restricted use of hazardous substances in
electrical and electronic products, indicate via labelling the hazardous substances
contained in the electrical and electronic products that they bring to market, indicate the
names and contents of the harmful substances and the components in which they are
located.
Names and contents of hazardous substances shall be specified in the product instructions
by following the format of the China standard SJ/T 11364-2014.
This requirement is effective from July 1, 2016.
11. Country Specific Notes
LIAISON
®
XS - Instruction for use Rev. H Page 11-5
11.4.2 List of components
Names and contents of hazardous substances as required by the Management Methods for
the Restriction of the Use of Hazardous Substances in Electrical and Electronic Products
(ROHS) - Order No. 32 of the China’s Ministry of Industry and Information Technology of on
January 21, 2016 and according to the format of the China standard SJ/T 11364-2014 are
reported here below.
O indicates that this toxic or hazardous substance contained in all the homogenous
materials of this part / system, is below the limit requirement as specified by China RoHS
Regulation
X indicates that this toxic or hazardous substance contained in all the homogenous
materials of this part / system, is above the limit requirement as specified by China RoHS
Regulation
Part Name
Toxic or Hazardous Substances and Elements
Lead
(Pb)
Mercury
(Hg)
Cadmium
(Cd)
Hexavalent
Chromium
(Cr6)
Polybrominate
d Biphenyls
(PBB)
Polybrominated
Diphenyl Ethers
(PBDE)
Washer Module
(ID 10035323)
Xo o o o o
Liquid Distribution
Valve
(10079687)
Xo o o o o
Starter Pump
(10064069)
Xo o o o o
WBDP Pump
(10035808)
Xo o o o o
11. Country Specific Notes
Page 11-6 LIAISON
®
XS - Instruction for use Rev. H
