Boule H50V Veterinary Hematology System User Manual

Original instructions

H50V User Manual

Table of Content

Medical

iv

Table of Content

1 Introduction ........................................................................................................... 7

1.1 Warranty Limitations .............................................................................. 7

1.2 Contact Details ........................................................................................ 8

1.3 Intended Purpose ..................................................................................... 9

1.4 Analyzer Overview ............................................................................... 10

1.5 Consumables Overview ......................................................................... 12

1.5.1 H50V Reagents ........................................................................ 12

1.5.2 H50V Detergent ....................................................................... 12

1.5.3 H50V Probe cleaner ................................................................ 13

1.5.4 Analyzer Control and Calibrator ............................................. 13

1.5.5 FCC Declaration of Conformity .............................................. 13

2 Safety Information .............................................................................................. 15

2.1 Emergency Procedures .......................................................................... 15

2.2 Alerts used in this Manual .................................................................... 15

2.3 Signs on Equipment .............................................................................. 16

2.4 Signs on Consumables .......................................................................... 18

2.4.1 Hazard Information on Consumables ...................................... 19

2.5 Safety Requirements ............................................................................. 21

2.5.1 Special Requirements ............................................................. 21

2.5.2 General Requirements ............................................................ 21

2.5.3 Limitations .............................................................................. 21

2.5.4 Infection Prevention ................................................................ 21

2.5.5 Electromagnetic Compatibility (EMC) Information .............. 22

2.5.6 Laser ........................................................................................ 22

2.5.7 Installation .............................................................................. 23

2.5.8 Operation ................................................................................ 23

2.5.9 Maintenance ............................................................................ 23

2.5.10 Consumables ........................................................................... 24

3 System and Function ........................................................................................... 26

3.1 Specification ......................................................................................... 26

3.2 Performance .......................................................................................... 27

3.3 Analysis Parameters .............................................................................. 28

3.4 System parts ........................................................................................... 29

3.5 User Interface ........................................................................................ 29

3.6 Test Interface ......................................................................................... 29

4 Installation .......................................................................................................... 33

4.1 Overview ............................................................................................... 33

4.1.1 Installation Checklist ............................................................... 33

4.2 Unpacking and Inspection ..................................................................... 34

Table of Content

Medical

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4.3 Space Requirements .............................................................................. 35

4.4 Power Supply Requirements ................................................................. 35

4.5 Environment Requirements ................................................................... 36

4.6 Waste Requirements .............................................................................. 36

4.7 Tubing Installation ................................................................................ 37

4.8 Changing Reagent .................................................................................. 38

4.9 Printer Setup ......................................................................................... 39

4.10 Date and Time ....................................................................................... 40

4.11 Adding User ........................................................................................... 40

4.12 Changing Language .............................................................................. 40

4.13 Transport and Storage Condition .......................................................... 41

5 Principles of Operation ....................................................................................... 42

5.1 Overview ............................................................................................... 42

5.2 Sample Aspiration .................................................................................. 42

5.3 WBC Test Principle .............................................................................. 43

5.3.1 Laser based Flow Cytometry .................................................. 43

5.3.2 Interpreting Scatter diagrams .................................................. 44

5.4 Test Principle of Hemoglobin Concentration ........................................ 45

5.4.1 Colorimetry Principle ............................................................. 45

5.5 RBC /PLT Test Principle ....................................................................... 46

5.5.1 Electrical Impedance Principle ................................................ 46

5.5.2 Volumetric Metering ................................................................ 47

5.5.3 RBC Parameters ...................................................................... 47

5.5.4 PLT Parameters ....................................................................... 48

5.6 WOC, WIC functions and RRBC mode ................................................ 49

5.7 Principles of Reticulocyte Analysis ....................................................... 49

5.7.1 RETIC_ABS ........................................................................... 50

5.7.2 IRF ........................................................................................... 50

6 Daily Operation .................................................................................................. 51

6.1 Overview ............................................................................................... 51

6.2 Preparations ........................................................................................... 52

6.3 Startup ................................................................................................... 52

6.3.1 Background Test ..................................................................... 53

6.4 Quality Control ..................................................................................... 54

6.5 Collection of Blood Samples ................................................................. 54

6.5.1 Whole blood collection ........................................................... 54

6.5.2 Pre-dilute sample preparation ................................................. 54

6.5.3 Blood tube mixer ..................................................................... 55

6.6 Data input .............................................................................................. 55

6.7 Running a Sample test ........................................................................... 57

6.7.1 Sample mode ........................................................................... 57

Table of Content

6.7.2 Animal settings ........................................................................ 57

6.7.3 Limit ........................................................................................ 58

6.7.4 Counting and Analysis ............................................................ 59

6.8 Data Query ............................................................................................ 59

6.8.1 Data Query .............................................................................. 60

6.8.2 Data Selection .......................................................................... 60

6.8.3 Data Export ............................................................................. 61

6.8.4 Data Deletion ........................................................................... 61

6.9 Reticulocyte Analysis ............................................................................ 62

6.9.1 Preparation of Reticulocyte samples ....................................... 62

6.9.2 Reticulocyte background test .................................................. 63

6.9.3 Reticulocyte test ...................................................................... 63

6.10 CV Value and Trend graph .................................................................... 64

6.11 Shutdown and Logout ........................................................................... 65

7 Quality Control ................................................................................................... 66

7.1 Overview ............................................................................................... 66

7.2 Quality Control Options ....................................................................... 67

7.3 Levey-Jennings QC ............................................................................... 68

7.3.1 L-J QC Setup ........................................................................... 68

7.3.2 L-J QC Graph .......................................................................... 71

7.3.3 L-J QC List ............................................................................. 72

7.4 X-B QC ................................................................................................. 72

7.4.1 X-B QC Edit ............................................................................ 72

7.4.2 X-B QC Run ............................................................................ 73

7.4.3 X-B QC Review ...................................................................... 73

7.5 X-R QC ................................................................................................. 74

7.5.1 X-R QC Setup ......................................................................... 74

7.5.2 X-R QC Graph ......................................................................... 75

7.5.3 X-R QC List ............................................................................ 76

7.6 X QC ...................................................................................................... 76

7.6.1 X QC Setup ............................................................................. 76

7.6.2 X QC Graph ............................................................................ 77

7.6.3 X QC List ................................................................................ 77

8 Calibration .......................................................................................................... 78

8.1 Overview ............................................................................................... 78

8.2 Calibration Frequency ........................................................................... 79

8.3 Handling of Calibrator and Control ....................................................... 79

8.3.1 Summary and Principle ........................................................... 79

8.3.2 Indication of deterioration ....................................................... 79

8.3.3 Mixing and handling of Calibrator and Control ..................... 79

8.4 Preparation ............................................................................................. 80

8.5 Calibration Modes ................................................................................ 81

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Medical

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8.5.1 Principles of the new Calibration coefficient .......................... 81

8.5.2 Validation of Calibration coefficient ....................................... 81

8.5.3 Manual Calibration .................................................................. 81

8.5.4 Standard Calibration ................................................................ 83

8.5.5 Blood Calibration .................................................................... 84

9 Maintenance ........................................................................................................ 86

9.1 Routine Maintenance ............................................................................ 86

9.1.1 Maintenance Procedures ......................................................... 87

9.1.2 Maintenance Setup .................................................................. 89

9.2 Intermittent maintenance ...................................................................... 90

9.2.1 Prime Reagent ......................................................................... 91

9.2.2 Cauterize Aperture .................................................................. 91

9.2.3 Flush Aperture ......................................................................... 91

9.2.4 Soak Impedance Transducer .................................................... 92

9.2.5 Prepare Shipping ..................................................................... 92

9.2.6 Other Maintenance Functions ................................................. 93

9.3 Maintenance by Service technician ....................................................... 93

9.3.1 Components Maintenance ....................................................... 93

9.3.2 Components Replacement ....................................................... 93

9.4 Disposal Information ............................................................................. 93

10 Advanced Setup ............................................................................................ 95

10.1 Parameter ............................................................................................... 95

10.2 Display .................................................................................................. 95

10.3 Transmit ................................................................................................ 95

10.4 Version .................................................................................................. 96

10.5 Service .................................................................................................. 96

10.6 System log ............................................................................................. 96

11 Troubleshooting ............................................................................................ 97

11.1 Troubleshooting Guidance .................................................................... 97

11.2 Troubleshooting ..................................................................................... 97

11.3 Obtaining Technical Assistance .......................................................... 100

11.4 Abnormal Results ................................................................................ 101

12 Appendix .................................................................................................... 107

12.1 Appendix A: Components and Consumables ...................................... 107

Section 1 Introduction

1 Introduction

This user manual contains instructions for the operation of the H50V Veterinary

Hematology System. Read this manual before installing, operating, handling, or

performing maintenance on the analyzer. Unauthorized personnel must not operate the

analyzer. This manual is intended for those installing, operating, handling, or

performing maintenance on the analyzer.

1.1 Warranty Limitations

• Service must be performed by Boule authorized service personnel.

• Use only Boule authorized reagents, cleaners, controls, and calibrators. If

these products are substituted, it may void the warranty.

• Operators and laboratory supervisors are responsible that Boule products are

operated and maintained according to the procedures described in manuals and

control inserts.

• Each H50V Veterinary Hematology System is tested using recommended

reagents, controls, calibrators, and cleaners. All performance claims are

generated as part of this complete system.

H50V Veterinary Hematology System

Product Code Product Name

1440101 H50V

Current Software Version

Software version V5.18.230523B001_ 196_024 or later.

Section 1 Introduction

1.2 Contact Details

Head Office:

Boule Diagnostics AB

DOMNARVSGATAN 4

163 53 Spånga, Sweden

Representative Companies:

(Manufacturer)

Boule Medical AB

DOMNARVSGATAN 4

163 53 Spanga, Sweden

USA

Clinical Diagnostic Solutions Inc.

1800 NW 65th Avenue

Plantation, FL 33313, USA

E-mail:

info@boule.com

Russia

Boule Medical LLC

142153, Moscow region

Podolsk, Novoselki village. Technopark area,

h. 13, bld. 2, office 4, room 107, Russia

Website:

boule.com

Distributor and Technical Support:

Contact Boule for information.

For distributor contact details, seeboule.com/boule-worldwide/.

Section 1 Introduction

1.3 Intended Purpose

Analyzer

H50V Veterinary Hematology System is intended for veterinary diagnostic use under

laboratory conditions. The analyzer uses multi-angle laser scattering flow cytometry to

differentiate between the 5 types of white blood cells (WBC). To analyze red blood cells

(RBC) and platelets (PLT), the analyzer uses the Coulter principle. Hemoglobin (HGB)

concentration is determined using colorimetry.

NOTE

Read this manual carefully before operation, especially the safety information.

Keep this manual in a safe place for later use.

Follow the instructions in this manual when operating the analyzer. Not following

the instructions could lead to erroneous analysis results, harm to the operator and/or

damage to the analyzer. It will also void any warranty.

Any changes to the procedures described in this manual, for example attempts to

shorten the analysis time, are likely to have negative impact on the precision of the

instrument.

Reagents

The H50V Veterinary Hematology Analyzer is interlocked with system specific Boule

reagents; H50V Diluent, H50V Lyse, H50V Sheath, and H50V Reticulocyte stain.

Cleaners

Specified Boule cleaners are intended for the cleaning and maintenance ofthe H50V

system; H50V Detergent and H50V Probe cleaner.

Calibrator

The Calibrator is used for the calibration ofthe H50V Veterinary Hematology

System.

Control

The Control is used to monitor the performance ofthe H50V Veterinary Hematology

System.

Section 1 Introduction

1.4 Analyzer Overview

Figure 1-1: Analyzer Front View

Part

Description/Function

1. Display

TFT-LCD Touch screen, which displays patient and QC

data and allows operator to enter the menu interface. Refer

to Section 6 for menu choices.

2.

Sample probe Aspirates sample and dispenses diluent.

3. Start plate Press to begin sample aspiration.

4.

Sample mixer Uniformly mixes samples before analysis.

1.

2.

3.

4.

Section 1 Introduction

1.

2.

3.

4.

5.

6.

7.

Figure 1-2: Analyzer cable and interface connections

Part

Description/Function

1. PS/2 port Keyboard/mouse.*

2. PS/2 port Keyboard/mouse.*

3. USB host ports Connects analyzer to USB devices.

4. LAN port

Connects analyzer directly to network.

5.

Parallel port Standard IEEE- 1284.

6. Serial port RS-232, disabled by default.

7.

Power Switch Switches power On or Off.

*Restart system after plugging in device.

Section 1 Introduction

1.5 Consumables Overview

1.5.1 H50V Reagents

H50V Veterinary Hematology System reagents are configured specifically for the

H50V system to provide optimal system performance. Non-compatible reagents may

affect the analyzer performance, result in serious mistakes, or accidents. In this manual,

any mention of a reagent refers to the Boule reagents intended for use with the H50V

system.

H50V- Lyse, Diluent, Detergent, Sheath, and Probe Cleaner should be kept between

15℃ and 30℃ after opening. Once opened and connected to the instrument, the product

shelf life is 60 days.

NOTE

Always read the Safety Data Sheet (SDS) of the reagent before use.

Reagents must be stored according to the recommendations to ensure optimal

performance. Protected from direct sunlight, undercooling, and overheating during

storage.

The reagent inlet tubes have a cap attached that minimizes evaporation and

contamination. Close the cap tightly.

Ensure all reagents are used before expiration date.

To ensure open container shelf life, do not keep bottles in dusty environment.

H50V Diluent

Diluent is a transparent isotonic fluid used for diluting the blood sample to enable blood

cell counting and classification.

H50V Lyse

Lyse lyses RBC and forms a stable complex with the released hemoglobin (HGB),

allowing the absolute count of WBC and the HGB concentration to be determined.

H50V Sheath

Sheath is used together with Lyse and Diluent for determining the WBC cell content,

allowing the 5-part differential to be performed on animal blood.

H50V Reticulocyte stain

Reticulocyte stain is used to stain red blood cells, so they can be counted and classified

based on their morphology and structure.

1.5.2 H50V Detergent

Detergent is an onboard cleaning function used to clean WBC cups, RBC cups, and

liquid system. It also reduces the risk of clogs in the system.

Section 1 Introduction

1.5.3 H50V Probe cleaner

Probe cleaner is used as an external system cleaner, aspirated through sample probe.

CAUTION

Detergent and Probe cleaner are alkaline cleaning agents.

(1) Avoid contact of reagent with skin and eyes.

(2) If in contact with skin, rinse with water.

(3) If in contact with eyes, rinse with water and seek medical treatment immediately.

(4) If ingested, induce vomiting, and seek medical treatment immediately.

1.5.4 Analyzer Control and Calibrator

Control and Calibrator are intended for monitoring analyzer performance and for

calibrating the analyzer, respectively.

1.5.5 FCC Declaration of Conformity

NOTE

This equipment has been tested and found to comply with the limits for a Class B

digital device, pursuant to part 15 of the FCC Rules. These limits are designed to

provide reasonable protection against harmful interference in a residential

installation. This equipment generates, uses and can radiate radio frequency energy

and, if not installed and used in accordance with the instructions, may cause

harmful interference to radio communications. However, there is no guarantee that

interference will not occur in a particular installation. If this equipment does cause

harmful interference to radio or television reception, which can be determined by

turning the equipment off and on, the user is encouraged to try to correct the

interference by one or more of the following measures:

Reorient or relocate the receiving antenna.

Increase the separation between the equipment and receiver.

Connect the equipment into an outlet on a circuit different from that to which

the receiver is connected.

Consult the dealer or an experienced radio/TV technician for help.

This device complies with part 15 of the FCC Rules. Operation is subject to the

following two conditions:

(1) This device may not cause harmful interference, and

Section 1 Introduction

(2) this device must accept any interference received, including interference that

may cause undesired operation.

Any changes or modifications not expressly approved by the party responsible for

compliance could void the user's authority to operate the equipment.

RF Exposure Statement

The device has been evaluated to meet general RF exposure requirement. The device

can be used in fixed exposure condition without restriction.

Section 2 Safety Information

2 Safety Information

This section includes information about safety symbols and signs on equipment.

2.1 Emergency Procedures

If there are any obvious signs of malfunction, such as smoke or liquid leaking out of

the analyzer, proceed as follows:

Disconnect the main power supply immediately by pulling out the power cord

from the main supply outlet and contact your authorized distributor.

2.2 Alerts used in this Manual

Symbol Indicates

Indicates a hazardous situation that, if not avoided, could result

in death or serious injury.

Indicates a hazardous situation that, if not avoided, could

result

in minor or moderate injury. Also used for activities interfering

with proper function of the analyzer.

Indicates information considered important but not hazard

related.

Indicates potential biohazard.

Indicates a laser hazard which, if non-compliance with

procedures or engineering controls, may result in laser damage

to eyes.

NOTE

WARNING

CAUTION

Section 2 Safety Information

2.3 Signs on Equipment

Signs placed on the instrument define areas that need special attention or areas that

contain danger. See Figure 2- 1.

Figure 2-1 Signs present on Analyzer front and back

If any sign comes off, it needs to be replaced by a new one. To obtain new signs, contact

your local Boule representative.

Caution. Refer to the

accompanying document

Caution. Hot surface

Laser Hazard

Protective earthing

Caution. Electric shock

Biohazard

Caution, may cause

personal injury

Power on

Section 2 Safety Information

Power off

Serial number

WEEE

Consult instructions for

use

Keep dry

Handle with care

CE mark of Conformity

Atmospheric pressure

limit

Date of Manufacture

Catalogue number

Manufacturer

Keep away from heat

and radioactive source

This side up

Do not roll

Stacking limit by

number

Relative humidity limit

Temperature limit

FCC mark of

Conformity

Figure 2-2 Symbols Analyzer

Section 2 Safety Information

2.4 Signs on Consumables

Temperature limit

Manufacturer

Use by

Catalogue number

Single use

Radio-frequency

identification

Calibrator

Control

Corrosive

Consult instructions for

use

Batch code

This side up

Stacking limit by

number

Keep dry

Do not roll

Content

Electronic instructions

for use

boule.com

Environmental hazard

Warning

Figure 2-3 Symbols Consumables

Caution

Section 2 Safety Information

2.4.1 Hazard Information on Consumables

Hazard Identification, H50V Diluent, H50V Sheath, H50V Detergent.

Hazard pictogram Not applicable.

Signal word

Not applicable.

Hazard code and statement

Not applicable.

Precautionary statements

Not applicable.

Supplemental information

Not applicable.

Hazard Identification, H50V Reticulocyte stain.

Hazard pictogram

Not applicable.

Signal word

Not applicable.

Hazard code and statement

Not applicable.

Precautionary statements

Not applicable.

Supplemental information

EUH210 Safety data sheet available on request.

Hazard Identification, H50V Lyse.

Hazard pictogram

Signal word

Hazard code and statement

Danger

H315 Causes skin irritation.

H318 Causes serious eye damage.

H411 Toxic to aquatic life with long lasting effects.

Precautionary statements

P273 Avoid release to the environment.

P280 Wear protective gloves, protective clothing and eye

or face protection.

P305+P351+P338 IF IN EYES: Rinse cautiously with

water for several minutes. Remove contact lenses, if

present and easy to do. Continue rinsing.

P310 Immediately call a POISON CENTER.

P391 Collect spillage.

P501 Dispose of contents and container to authorized

waste disposal facility.

Supplemental information

Contains: DODECYLTRIMETHYLAMMONIUM

CHLORIDE

Section 2 Safety Information

Hazard pictogram

Signal word

Hazard code and statement

Precautionary statements

Supplemental information

Danger

H314 Causes severe skin burns and eye damage.

H412 Harmful to aquatic life with long lasting effects.

P264 Wash hands thoroughly after handling.

P273 Avoid release to the environment.

P280 Wear protective gloves, protective clothing and eye

or face protection.

P303+P361+P353 IF ON SKIN (or hair): Take off

immediately all contaminated clothing. Rinse skin with

water.

P305+P351+P338 IF IN EYES: Rinse cautiously with

water for several minutes. Remove contact lenses, if

present and easy to do. Continue rinsing.

P310 Immediately call a POISON CENTER.

Contains: SODIUM HYDROXIDE

Hazard Identification, H50V Probe cleaner.

Section 2 Safety Information

2.5 Safety Requirements

This section includes the safety requirements for installing, handling, operating, and

performing maintenance on the analyzer. Read this section carefully before use.

2.5.1 Special Requirements

• Do not use the analyzer for other purposes than described in this manual, or by

Boule technical bulletin covering an application.

• Only use the consumables mentioned in this manual.

2.5.2 General Requirements

• For all procedures and activities, for example starting the analyzer, follow the

instructions in the manual. Not doing so may cause erroneous analysis results,

damage to the analyzer, or personal injury.

• Keep long hair, fingers, and clothes at a safe distance from rotating parts.

• Do not spill sample, reagents, or other liquids on the analyzer in such a way that

it can leak through the analyzer casing.

• Do not drop or place objects on the analyzer.

• Do not touch the circuit.

• The analyzer must be connected to a receptacle with correct voltage, and

grounding at the same time.

• Avoid damaging the power cord. Do not put any device upon the power cord.

Do not pull the power cord.

• Turn off the power before connecting other devices (host computer, printer).

• Only use the AC adapter provided by Boule. Using other AC adapters may cause

erroneous analysis results.

• Do not remove the casing of the H50V analyzer. High voltages inside the

analyzer present a risk of electrical shock.

• Do not attempt to modify or rebuild the H50V analyzer. Doing so will void your

warranty. Boule takes no responsibility for any personal or material damage

resulting from such actions.

2.5.3 Limitations

• Boule products do NOT make diagnoses on patients. Boule products (systems,

software, and hardware) are intended for professional use in medical practices,

hospitals, and clinical laboratories to support medical diagnoses. This data, in

conjunction with other diagnostic information and the evaluation of the patient’s

condition, can be used by a trained clinician to establish a patient’s diagnosis

and to define a clinical treatment.

2.5.4 Infection Prevention

• As there is no assurance of the absence of HIV, Hepatitis B or C viruses or other

infectious agents in animal blood samples, controls, calibrators and waste, these

Section 2 Safety Information

products should be handled as potentially biohazardous. Refer to local

regulations and established laboratory protocol for handling biohazardous

materials. This should include use of gloves, lab coat and eye protection.

• All the components and the surface of the analyzer are potentially infectious.

• The sharp sample probe contains residues of clinical specimens, controls, or

calibrators. Consider the sample probe as infectious and avoid direct contact.

• Wear protective clothing and rubber gloves during operation, maintenance,

service, or repair. Wash hands with disinfectant after work.

• Do not touch the waste and its components without proper protection.

• If you accidentally come into contact with infectious material, immediately

wash with water and then sterilize the affected part according to laboratory

disinfection procedures.

2.5.5 Electromagnetic Compatibility (EMC) Information

• Evaluate the electromagnetic environment prior to installation.

• Do not use this device in close proximity to sources of strong electromagnetic

radiation (e.g., unshielded intentional RF sources),as these can interfere with

proper operation and result in erroneous analysis results.

2.5.6 Laser

• The analyzer is equipped with a semiconductor laser of wavelength λ 529-535

nm. Class 3B laser product with 11 mW of maximum power output. Do not

remove the protective cover of the laser. Only trained maintenance personnel

should open the cover. Avoid direct eye exposure to the laser beam.

CAUTION. ELECTRIC SHOCK

The analyzer has transport protection inserts which should be removed before

installation.

Transport protection must be removed, and analyzer closed before connecting the

analyzer to the main power supply.

Section 2 Safety Information

2.5.7 Installation

• The analyzer must be installed in a dry and dust-free place. Pollution degree 2

according to standard IEC 61010- 1.

• Installation site must be well ventilated.

• Only use the analyzer indoors and connect it to a grounded mains supply

providing correct voltage.

• Do not expose the analyzer to large temperature differences, or direct sunlight.

• Do not spill liquid on the analyzer.

• Avoid vibration. The analyzer should be put into a Styrofoam box to prevent

damage during storage and transport. Improper package may lead to abnormal

operation of the instrument.

• The analyzer does not produce ionizing radiation. Placing the analyzer near

other equipment that generate strong ionizing radiation, such as X-ray, or γ-

ray, may cause erroneous results.

• The equipment should not be installed in a place that stores chemicals or

generates gas.

• The applied frequency and voltage should be consistent with that stated in the

instruction for use. The analyzer should be equipped with precision power

supply or Uninterruptible Power Supply (UPS) as specified.

• The analyzer is heavy. Use two-person lift, proper tools and follow relevant

safety code when moving the analyzer.

• Improper use of reagents or incorrect operation may cause erroneous results.

2.5.8 Operation

• H50V Veterinary Hematology System must be operated by well-trained

personnel exclusively. Unqualified operators may cause risks of personal

injuries and property damage.

• Failing to operate in accordance with the instructions may damage the analyzer

and result in erroneous results.

• Maintenance should be carried out by authorized technicians. Non-standard

maintenance performed by unauthorized technicians will cause erroneous test

results.

• Invalid hardware or software affects the accuracy of test results. The operator

needs to contact a Boule local distributor or an authorized service technician as

soon as possible.

2.5.9 Maintenance

• Maintenance is necessary for normal operation. Clean the analyzer regularly to

avoid erroneous results and to minimize the risk of contamination.

• To prevent infection, electric shock and burn, the operator must wear rubber

gloves in maintenance work. Wash hands with disinfectant after work.

• If the analyzer is not used for a long time, empty the liquid system according to

Section 2 Safety Information

the procedure before disuse. Refer to Section 9.2.5 Prepare Shipping.

• Always replace with fuses ofthe same rating.

2.5.10 Consumables

• Check the labels on the packaging.

• Read the relevant Safety Data Sheets (SDSs) available at boule.com before

handling reagents and cleaners.

• Reagents should only be used by technically qualified personnel.

• Avoid direct contact with reagents, it may irritate eyes, skin, and mucous

membranes.

• If a reagent comes in contact with skin, immediately rinse with plenty of water.

• If a reagent comes in contact with the eye, immediately rinse with plenty of

water and seek medical advice.

• Follow established emergency measures in the laboratory.

• Protect the reagents from contaminants.

• Reagents must be used before stated expiration date.

• Handle reagents properly to prevent bubbles forming. Do not shake. Do not use

the reagent immediately after transport. Let reagents equilibrate to room

temperature, according to stated temperature limits before use.

• Do not spill reagents. If it happens, wipe away with a cloth.

• If you accidentally swallow reagents, immediately seek medical attention.

• Diluent is a good conductor. Spilling Diluent next to an electrical cord or an

electrical device may result in electric chock. If this happens, turn off the power

switch, unplug the power cord, and clean up the Diluent.

• Probe cleaner is strongly alkaline. Do not let it contact the skin or clothes. If this

happens, rinse the skin and clothes immediately with plenty of water.

• The Probe cleaner contains sodium hypochlorite and can corrode the analyzer

surface. If the cleaner spills on the analyzer, immediately wipe away with a cloth.

• Place the reagents on the same level as the analyzer, or lower.

• Disposal of residual reagents, cleaning agents, and waste must comply with

local laws and regulations.

Section 3 System and Function

3 System and Function

3.1 Specification

Physical

Size (Analyzer) HWL ≤ 410 x 270 x 510 mm

Weight (Analyzer)

≤ 26 kg

Communication interface ports

4 USB ports/1 LAN port that supports

LIS/HIS communication through HL7

protocol

Operating Environment

Temperature

15°C – 35°C

Relative humidity

≤85%

Barometric pressure

80kPa – 106kPa

Storage Environment

Temperature

-20°C – 55°C

Relative humidity

≤95%

Barometric pressure

50kPa – 106kPa

Electrical

Fuse specifications

250V/T3.15AL

Overvoltage category

Class II

Maximum sound pressure

65 dBA

Measuring Principles

WBC, 5Diff

Laser

HGB

Colorimetry

RBC, PLT

Electrical impedance

MCV, HCT, RDW_CV, RDW_SD,

MPV, PDW, MCH, MCHC and PCT

Obtained by calculation

Performance

Aspirated sample volume (Whole

blood)

20 µL

Aspirated sample volume (Pre-dilute)

20 µL

Number of samples per hour

Up to 60 / h

Analysis time

<1 min

QC capabilities

Mean, SD, CV%, Levey-Jennings, X-bar

System Information Indicators on

parameter abnormalities

Yes

Section 3 System and Function

3.2 Performance

Precision

Parameter

·

Precision Range

CV%

WBC

3.5×10

9

/L - 15.0×10

9

/L

≤3.0%

RBC

3.00×10

12

/L - 6.00×10

12

/L

≤2.0%

HGB

100 g/L - 180 g/L

≤2.0%

PLT

100×10

9

/L - 149×10

9

/L

150×10

9

/L - 500×10

9

/L

≤6.0%

≤5.0%

HCT

35% - 50%

（

HCT

）

≤2.0%

MCV

70fL - 120fL

（

MCV

）

≤1.0%

Carryover

Parameter Carryover (%)

WBC

RBC

HGB

PLT

≤0.5%

≤0.6%

≤1.0%

Displayed Range

Parameter

Displayed Range

WBC

0 – 999 × 10

9

/L

RBC

0 – 99 × 10

12

/L

HGB 0 – 35 g/dL

HCT

0 – 99%

PLT

0 – 5000 × 10

9

/L

Linearity

Parameter

Linear Range

Correlation (r)

WBC

0 – 400 ×10

9

/L

≥0.990

RBC

0 – 8 ×10

12

/L

≥0.990

HGB

0 – 25 g/dL

≥0.990

PLT

0 – 5000 ×10

9

/L

≥0.990

Background Count

Parameter

·

Acceptable Range

WBC

≤0.20×10

9

/L

RBC

≤0.02×10

12

/L

HGB

≤0.1g /dL

PLT

≤10.0×10

9

/L

Section 3 System and Function

3.3 Analysis Parameters

The analyzer will automatically analyze and arrange sample data to show the RBC

count, PLT count and the WBC five-part differential. H50V Hematology Analyzer

generates up to 34 test parameters including two histograms and two scatter diagrams.

Abbreviation

Full Name

Unit

WBC White Blood Cell Count

10

9

/L

LYM% Lymphocyte Percent %

MON%

Monocyte Percent

%

NEU%

Neutrophil Percent

%

EOS%

Eosinophil Percent

%

BASO%

Basophil Percent

%

LYM#

Lymphocyte Count

10

9

/L

MON#

Monocyte Count

10

9

/L

NEU#

Neutrophil Granulocyte Count

10

9

/L

EOS#

Eosinophil Granulocyte Count

10

9

/L

BASO#

Basophil Granulocyte Count

10

9

/L

RBC

Red Blood Cell Count

10

12

/L

HGB

Hemoglobin

g/L

HCT

Hematocrit (relative volume of erythrocytes)

%

MCV

Mean Corpuscular Volume

fL

MCH

Mean Corpuscular Hemoglobin

pg

MCHC

Mean Corpuscular Hemoglobin

Concentration

g/dL

RDW_CV Red Blood Cell Distribution Width repeat %

precision

RDW_SD

Red Blood Cell Distribution Width STDEV

fL

PLT

Platelet Count

10

9

/L

MPV

Mean Platelet Volume

fL

PDW * Platelet Distribution Width fL

PCT *

Plateletcrit

%

P_LCR

Large Platelet Percent

%

P_LCC Large Platelet Count

10

9

/L

ALY% * Abnormal Lymphocyte Percent %

ALY# * Abnormal Lymphocyte Count

10

9

/L

LIC% * Large Immature CellPercent %

LIC# * Large Immature CellCount

10

9

/L

NRBC% * Nucleated Red Blood CellPercent %

NRBC# * Nucleated Red Blood CellCount

10

9

/L

RETIC-ABS *

Reticulocyte absolute value

10

12

/L

Section 3 System and Function

Abbreviation

Full Name

Unit

RETIC * Reticulocyte %

IRF *

Immature Reticulocyte Fraction

%

* PCT, PDW, ALY%, ALY#, LIC%, LIC#, NRBC% and NRBC# are the inferred

parameters. They and RETIC parameters are for research use. The number of reported

parameters may vary according to the animal species. RETIC parameters measurement

using Retic mode and Retic reagents may not be locally available. Contact your local

supplier for more info.

3.4 System parts

The analyzer consists of analysis part, information management part, result output, and

external printer (optional). The analysis part is mainly composed of laser parts,

automatic sampler, A/D converter, central control panel, WBC measurement unit, flow

system, and screen display.

CAUTION

The analyzer is heavy. Use two-person lift, proper tools and follow relevant safety

code when moving the analyzer.

Unpack the analyzer and check that the appearance is intact. Ensure that there is no

damage during transport.

WARNING

Do not open the protective cover of the laser. Only trained maintenance personnel

should open the cover. Avoid direct eye exposure to the laser beam.

3.5 User Interface

Turn on the power switch located on the left side, the analyzer program starts and enter

the startup interface. Refer to Section 6.3 Startup for details on how to log in.

3.6 Test Interface

After initialization, the operator may choose to log in as a user or as an administrator.

The administrator account is default and gives access to all enabled features. A basic

Section 3 System and Function

user can for example not delete data, use the export function, or calibrate the analyzer.

After logging into the administrator account, the analyzer enters the Test interface. See

Figure 3- 1.

Figure 3-1 Test Interface

This interface can be divided by functions into the following areas:

1. Function button area Displays function buttons.

2. Parameter information display area Displays results of each parameter.

3. Information prompt area Displays image of active animal profile

and analyzer warnings.

4. Running mode and Analysis mode Displays the running mode:

Whole Blood or Pre-dilute.

Displays the Analysis mode:

CBC+5DIFF or CBC+5DIFF+RRBC.

5. Prompt area of abnormal results Displays abnormal results.

6. Graphic display area Displays the scatter diagrams (Size and

Diff) and histogram.

7. System status area Displays time, date, operator, next serial

number, and printer status.

There are three sets of function buttons.

1.

2.

3.

4.

5.

6.

4—

7

.

1.

Section 3 System and Function

The first set:

Figure 3-2 Function Button 1

Test: enter Test interface to perform sample measurement.

Data: enter Data interface and search sample results.

QC: enter the QC interface to perform quality control.

Cal: enter the Cal interface to perform calibration.

Setup: enter the Setup interface to set system parameters.

The second set:

Figure 3-3 Function Button 2

Next sample: add and edit new sample information.

Mode switch: switch the test mode between Background, Whole Blood or Pre-dilute

sampling mode. Switch the analysis mode between CBC+5DIFF or

CBC+5DIFF+RRBC.

Animal: switch profile settings.

Soak: perform soak cleaning.

Dispense: dispense sheath fluid from sample probe.

Prime: enable new liquid in the liquid system.

The third set:

Figure 3-4 Function Button 3

Pre. record: view the previously recorded sample. The button is gray if the current

sample is the first one.

Next record: view the next record. The button is gray if the current sample is the last

one.

Audit/Cancel Audit: toggles between Audit and Cancel Audit. Only available with

administrator account. Can be used to mark results as approved.

Edit result: Only available with administrator account. Used to modify individual

parameter results if adjustment needed after verification by other method. Tap Recover

to restore original results.

Print: print sample results.

Transmit: transmit sample data.

Section 4 Installation

4 Installation

4.1 Overview

CAUTION

Environment Requirements

Temperature: 15℃ – 35℃

Relative humidity: ≤ 85%

Place the analyzer on a smooth and stable surface.

Do not expose the analyzer to large temperature differences, or direct sunlight.

Use a separate AC receptacle and install a stabilized voltage supply or a UPS

(Uninterruptible Power Supply).

CAUTION

Installation of the analyzer by unauthorized personnel could result in personal

injury, and is not covered by the warranty. Never attempt to install or operate the

analyzer without an authorized representative.

The analyzer has been thoroughly tested before delivery. It should be carefully packed

before transport to avoid damage. Check the package thoroughly to reveal any physical

damage at arrival. If damaged, immediately contact the local distributor.

4.1.1 Installation Checklist

Follow the quick Installation Checklist step by step for best installation results.

Unpack and check components.

Verify analyzer placement and environment instructions.

Remove all transport protection. See included instructions.

Connect all accessories.

Connect all reagents.

Connect waste tubing.

Connect power cord and start the analyzer.

After initialization, prime the system to ensure the liquid system is filled.

Verify the background count.

Section 4 Installation

Perform quality control and calibrate if needed. Refer to Section 8,

Calibration.

After initial setup, it is recommended to make a backup of the analyzer

database and keep for personal records.

4.2 Unpacking and Inspection

Take out analyzer and accessories from the shipping carton. Keep the packing material

for future transport or storage. Check the following:

• Leakage or soakage

• Mechanical damage and bare leads

• Included instructions and inserts

• Quantity of accessories

Contact the local distributor if any problem occurs.

The following items are included *:

Part Quantity

H50V 5-Part-Diff Auto Hematology Analyzer 1

H50V User Manual 1

H50V User Manual translation 1

H50V Quick Reference Guide 1

Installation checklist 1

Transport protection removal instruction 1

Quality certificate 1

Power Cord 1

Ground Wire 1

Waste Sensor Cable 1

Reagent bottle tray 1

Lyse inlet tubing (500 mL) 1

Lyse inlet tubing (200 mL) 1

Diluent inlet tubing 1

Sheath inlet tubing 1

Detergent inlet tubing 1

Waste outlet tubing 1

Waste container 1

Reagent cap wrench 1

Reagent Barrel Cover support 3

Plastic Test Tube – Predilution 200

Plastic Test tube – Probe cleaner 1

Keyboard 1

Section 4 Installation

A set of touch pen 1

Network Cable 1

Filter 2

O-ring 22X3.5 2

O-ring 18X5 1

Fuse 2

*Local variations may apply. Note that some documents such as SDS, translated SDS

and User Manual translations may only be available digitally.

4.3 Space Requirements

Make sure that there is enough space for operation, maintenance, and replacement of

reagents.

• Place the analyzer on a clean, stable, and non-vibrating horizontal surface.

• Indoor Use near a grounded mains supply.

• Leave 20 cm of free space behind the analyzer for ventilation.

• Leave 50 cm of free space above analyzer and allow 50 cm on either side of

analyzer to be cleared for service access.

• Leave enough space for Reagent bottle tray on the right side of the analyzer.

The reagent bottle tray is used only with 1.9 L reagent containers.

• Ensure that there is sufficient space beneath the analyzer for placing reagent and

waste containers.

4.4 Power Supply Requirements

Make sure that the H50V system is placed at the desired location before connecting

power.

Optimal Voltage

Voltage Range

Frequency

AC 220V

100V

–

240V

~

50 – 60 Hz

Section 4 Installation

WARNING

Use a ground connection to ensure the accuracy of the analyzer and the safety of

the operator.

A fluctuating voltage could impair the performance and reliability of the analyzer.

Proper precautions, such as installation of a voltage stabilizer (not provided by the

manufacturer), should be taken before operation.

Frequent power failure may damage or seriously decrease performance and

reliability of the analyzer. Proper precautions, such as use of an Uninterruptible

Power Supply (UPS, not provided by the manufacturer), should be taken before

operation.

4.5

Environment Requirements

•

Ambient Temperature: 15℃ – 35℃ (Optimal temperature is 25℃).

•

Professional laboratory use, indoor use only.

•

Avoid using the analyzer at extremely high or low temperatures.

•

Keep the analyzer away from direct sunlight.

•

Choose a well-ventilated place.

•

Pollution degree 2 according to standard IEC 61010-1.

•

Evaluate the electromagnetic environment prior to installation. Do not place the

analyzer in an environment containing high energy sources.

•

Electromagnetic compatibility design for class B.

•

Keep the analyzer away from communication equipment which may interfere

by producing high frequency electric waves.

CAUTION

Do not use this device near sources of strong electromagnetic radiation (e.g.,

unshielded intentional RF sources), as these can interfere with proper operation and

result in erroneous results.

4.6 Waste Requirements

Always follow the local guidelines for open drain.

• Place the instrument close to a waste container or a drain suitable for disposal

of used reagents.

• Check that the drainage is suitable for disposal of chemical and biological waste.

Section 4 Installation

WARNING

Follow the established biohazard protection barrier of your lab. This should include

gloves, lab coat and eye protection.

To prevent environmental pollution, follow local guidelines for waste disposal and

open drain.

4.7 Tubing Installation

There are five liquid interfaces on the back panel: DETERGENT, DILUENT, LYSE,

SHEATH and WASTE. See Figure 4-1. Each of them is wrapped with a cap to avoid

contamination before delivery. Uncover and set the caps aside for further use, if needed.

Figure 4-1 Reagent and Waste Interface, back panel

NOTE

After installation, all tubes should be in a relaxed state and without distortion.

Using tools for tubing installation is prohibited. Only install by hand.

The reagent bottle cannot be used if damaged, leaking, expired, or if other

anomalies exist. Contact your local distributor.

Place the reagents on the same level as the analyzer or lower. The reagent bottle

tray intended for 1.9 L reagent containers should be placed next to the analyzer.

Place the end of the waste tube at least 50 cm lower than the analyzer.

Section 4 Installation

Reagent Tubing Installation

1. Connect the Lyse inlet tube to the yellow LYSE interface on the back panel.

2. Connect the Diluent inlet tube to the red DILUENT interface on the back panel.

3. Insert the Detergent inlet tube to the blue DETERGENT interface on the back panel.

4. Connect the Sheath inlet tube to the green SHEATH interface on the back panel.

5. Connect each reagent tube assembly into the corresponding reagent container and

fasten the cap properly.

Waste Tubing Installation

1. Connect the Waste outlet tube with black faucet to the black WASTE interface on

the back panel.

2. Insert the BNC connector to the SENSOR outlet on the back panel.

3. Properly fasten the waste tubing in your depressurized waste container. Make sure

the waste tubing length is maximum 200 cm and the end of the waste tube is placed

at least 50 cm lower than the analyzer.

4.8 Changing Reagent

NOTE

The reagent container lids may be difficult to open. Use the wrench key provided

with the analyzer.

1. Insert the reagent inlet tubing into the reagent container. Ensure that the color coding

of inlet and reagent corresponds correctly.

2. Tighten the cap. Use cap intended for the size of reagent container used.

3. Select Setup to enter Setup interface, see Figure 4-2.

Section 4 Installation

Figure 4-2 Setup Interface

4. In the Setup interface, select Reagent. A popup dialogue appears.

Activation date, total amount, lot, valid period, and remaining amount are shown

for the respective reagents.

5. To change reagent, select Replace for the corresponding reagent type. A popup

dialogue appears.

6. Select Activate to activate the new reagent. A 15 second countdown starts.

7. Scan the RFID card corresponding to the reagent with the RFID reader. A tick

sound will indicate a successful card reading.

8. Enter LOT number and verify the expiry date for the open container.

9. A successful activation is displayed in a dialogue box.

10. Perform a background test. Ensure that results are within the recommended range.

CAUTION

To ensure precision and obtain reliable test results, perform quality control after a

reagent has been replaced.

4.9 Printer Setup

To set up a new printer:

1. In the Setup interface, select Service.

2. Enter password = printer.

3. Connect the printer and search for the correct driver for the connected printer.

Section 4 Installation

When a printer has been connected:

1. In the Setup interface, select Print.

2. Choose Printer type: USB printer (A5), USB printer (A4), Recorder, or External

Recorder.

3. Choose Print format: print with histogram or print without histogram.

4. Set Auto print to On or Off. If turned on, test result will automatically be printed

after counting. If turned off, printing is done manually.

5. Choose Color: Color or Grayscale.

6. Top Margin: enter a number if you want to have a top margin.

7. Choose Suffix: PDF or PNG.

8. Set Remark to On or Off.

9. Select OK to save the settings.

4.10 Date and Time

1. Enter the Setup interface and select Time.

There are three different formats to choose between: YYYY-MM-DD, MM-DD-

YYYY and DD-MM-YYYY. Y indicates Year, M indicates Month and D indicates

Day.

2. Select OK to save the settings.

4.11 Adding User

An administrator can perform modifications in user accounts. Modifications include

adding or deleting user accounts and administrating passwords.

To add a new User, do the following:

1. In the Setup interface, select User.

2. Select Add to enter a new user into the system.

3. Enter Username, Name, Password, and Confirm password.

4. Select User Group: Basic user or Administrator.

The basic user and the administrator are given different permissions. The administrator

has full access to all enabled functions. The basic user cannot for example delete data

or edit results.

5. Select OK to save settings.

4.12 Changing Language

It is possible to change the language settings.

1. In the Setup interface, select Service.

Section 4 Installation

2. Enter password lan.

3. Select the desired language from the drop-down menu.

4. Select OK to save settings.

5. Restart analyzer to activate the new language.

For requests to have the software interface in an additional language, contact your sales

representative.

4.13 Transport and Storage Condition

It is important that the H50V system is emptied and cleaned to avoid reagent

crystallization in the fluid system tubing. If this is not done it may lead to complicated

and expensive repairs.

Perform the Prepare Shipping operation when:

• the analyzer will be transported.

• the analyzer will not be used for one week or longer.

The following steps gives an overview of the procedure. For detailed instructions, refer

to Section 9.2.5 Prepare Shipping.

1. From the Setup interface, enter the Maintenance interface and select Prepare

Shipping.

2. Remove all reagent inlet tubes from the reagent containers and allow the liquid

system to be emptied.

3. Place all reagent inlet tubes into a bottle of distilled water.

4. Repeat step 1 to allow the liquid system to be filled with distilled water.

5. Repeat step 1 and remove reagent inlet tubes from the water bottle.

6. The analyzer empties the liquid system.

7. Turn off the analyzer.

8. Remove reagent tubing from the back of the analyzer and keep them intact and well

stored.

9. The analyzer is now ready for transport or storage.

NOTE

Storage temperature: -20℃ – 55℃

Relative Humidity: ≤ 95%

Atmospheric pressure: 50kPa – 106kPa

Before shipping, perform external disinfection

Section 5 Principles of Operation

5 Principles of Operation

5.1 Overview

Measurement methods used in the 5-Part H50V analyzer are:

• Electrical impedance method to detect the amount and the volume distribution

of RBC and PLT. Also used for total WBC.

• Transmission spectrophotometry for determining HGB.

• Laser-based flow cytometry for total white blood cell (WBC) count, and the

five-part differential count of WBC.

During each analysis cycle the sample is aspirated, diluted, and mixed before each

parameter is detected.

The analyzer will flag individual parameters that are outside of specific reference ranges,

as well as provide sample pathology indicators for specific conditions where manual

review by blood smear is recommended.

5.2 Sample Aspiration

The 5-Part H50V analyzer supports Whole blood sampling mode and Pre-diluted

sampling mode.

Sampling Mode

Aspiration volume

Whole Blood

Pre-dilute

20µL

The whole blood sample is aspirated into the analyzer by a precision stepper motor and

distributed into different measuring channels.

Section 5 Principles of Operation

5.3 WBC Test Principle

5.3.1 Laser based Flow Cytometry

a. Blood suspension

(sample)

b. Sheath flow

c. Laser

d. Light scatter

detectors

Figure 5-1 Laser Flow Cytometry Principle

The H50V use a laser-based flow cytometry method for total white blood cell (WBC)

count, and differential count of the subpopulations— neutrophils (NEU), lymphocytes

(LYM), monocytes (MONO), eosinophils (EOS), and basophils (BASO).

For detection, a laser beam is passed through the sample. See Figure 5- 1. When cells

pass through the detection zone, the light is scattered and measured by a photoconductor

that converts the light into an electrical impulse. The number of generated impulses

correlates with the number of cells, whereas the light scatter is used to determine cell

granularity and shape.

The measurements are based on cell size and complexity (granularity) and detected

using three angles: Small Angle (SA), High Angle (HA) and Super Wide Angle

(SWA). See Figure 5-2.

Figure 5-2 Detection Angles

Section 5 Principles of Operation

SA detects cell volume, HA cellular complexity, and SWA takes the cellular

granularity into account. The analyzer displays the results in two scatter diagrams

referred to as “Size” and “Diff”. For example, see Figure 3-1.

The Scatter diagram “Size” show scattered light detected by SA (cell volume) on the Y-

axis, and HA (cellular complexity) on the X-axis. See Figure 5-3. The Scatter diagram

“Diff” show a projection of scattered light detected from all three angles by comparing

signals from SWA and HA on the Y-axis, to the signals from SA and HA on the X-axis.

See Figure 5-4.

Figure 5-3 Size Scatter diagram

Figure 5-4 Diff Scatter diagram

5.3.2 Interpreting Scatter diagrams

The scatter diagrams provide a snapshot of cellular morphology that complement the

numerical results. They can be a valuable tool for a quick interpretation of sample

quality, sample results, and the health status of the patient.

Each event in the scatter diagrams represents a particle that has passed through the laser

beam. The events come together to form clusters in the scatter diagrams, where each

cluster represents a population of cells. The density of the clusters indicates the number

of cells in each population. See Figure 5-2 and Figure 5-3.

The analyzer classifies five White Blood Cell (WBC) subpopulations:

Neutrophils (NEU) — are the primary defense against infection and generally the

largest of the white blood cell populations. They are found to the right of the

monocytes in the scatter diagrams. Depicted in Blue.

Lymphocytes (LYM) — make up a relatively large portion of the white blood cells.

They are an essential part of the immune system producing antibodies and cytokines.

LYM can vary in size but are generally found far down on the y-axis. Depicted in

Green.

Section 5 Principles of Operation

Monocytes (MONO) — are phagocytes involved in the inflammatory response. They

are typically larger and more complex than LYM and found above and to the right of

these. Depicted in Pink.

Eosinophils (EOS) — are associated with allergic disease and parasitic infection and

they are often placed high or to the right in the scatter diagrams. However, the

granularity of EOS can differ significantly between different species which affects the

scatter of light, and their position can vary. Depicted in Red.

Basophils (BASO) — are the smallest of the major white blood cell populations that

are classified by the analyzer. They are typically found to the right of the monocytes

and below the neutrophils. Depicted in Black.

Gray events represent ghost cells that appear when the RBCs dissolve into pieces on

the scatter diagram.

Increased or decreased density of a cluster can indicate an abnormality that may require

further investigation. Distinct clusters mean the analyzer can classify the cells correctly.

A slight overlap is normal but if the clusters significantly overlap there is a risk for

misclassification. In such cases, it is recommended to take a new sample or confirm

results with a manual blood smear count.

5.4 Test Principle of Hemoglobin Concentration

5.4.1 Colorimetry Principle

To determine HGB concentration, the RBCs are lysed so that HGB is released and can

be measured using transmission spectrophotometry. Light emitted by a LED lamp is

allowed to pass the flow chamber and transmitted light is detected by an optical sensor

mounted on the opposite side. Hemoglobin concentration is proportional to the

absorbance at 540 nm wavelength.

Figure 5-5 HGB detection

Solution Filter Photodiode

LED lamp

Section 5 Principles of Operation

5.5 RBC /PLT Test Principle

5.5.1 Electrical Impedance Principle

The H50V analyzer uses an impedance method for obtaining red blood cell (RBC) and

platelet (PLT) counts. With impedance, each cell that passes through the aperture causes

a drop in the electrical current, a pulse. The number of generated pulses correlates with

the number of cells that passes the aperture, whereas the amplitude of the pulse is related

to the size of the cell. See Figure 5-6.

a. Electrode

b. Diluted sample

c. Aperture

d. Negative pressure

e. Voltage source

f. Sensing zone

g. Voltage

h. Pulse

i. Time

Figure 5-6 Electrical Impedance Method

RBC and PLT counts are displayed in histograms. The x-axis shows cell size and the y-

axis number of counted cells. See Figure 5-7. Histograms can be used to interpret

measurement results and assess sample quality.

Figure 5-7 RBC and PLT Histograms

Section 5 Principles of Operation

5.5.2 Volumetric Metering

The volumetric metering unit controls the sample size that pass the aperture during

counting to obtain the exact counts in quantitative samples. The volumetric metering

unit includes the metering tube and two photoelectric sensors. See Figure 5-8.

Figure 5-8 Volumetric Metering

The metering tube is emptied before testing. The analyzer starts counting when the

liquid level passes the start detector, and an electrical signal is generated. The counting

stops when the liquid level reach the stop detector. The analyzer will indicate if bubbles

or other abnormalities appear in the flow system, by display of the "Bubble" or "Clog"

alarm. Refer to Section 10 Troubleshooting.

5.5.3 RBC Parameters

• RBC Count

The analyzer obtains the number of red blood cell (RBC) by directly measuring the

corresponding number of electrical pulses. The unit is 10

12

/L.

• MCV

The mean corpuscular volume (MCV) is the average volume of individual red blood

cells. The MCV is derived from the RBC size distribution data. The unit is fL.

• HCT

The hematocrit (HCT) is the ratio of red blood cells to plasma. It is expressed as a

Section 5 Principles of Operation

percentage of the whole blood volume. The HCT is calculated from the RBC count and

the MCV as follows.

• MCH

The mean corpuscular hemoglobin (MCH) is the average amount of hemoglobin in the

red blood cell and being expressed in pg. The MCH is calculated from the RBC and the

HGB as follows.

• MCHC

The mean corpuscular hemoglobin concentration (MCHC) is the ratio of the weight of

hemoglobin to the volume of the average red blood cell. It is expressed in g/dL and

calculated from the HGB and the HCT as follows.

• RBC Distribution Width

The RBC Distribution Width (RDW), which is obtained from the RBC histogram, is

the geometric standard deviation of RBC volume distribution (10 GSD).

• RDW-CV

The RDW-CV is derived from the RBC histogram and being expressed in percent.

• RDW-SD

The RDW-SD is the width of the RBC distribution histogram excluding 20% of the

peak value. The unit is fL.

5.5.4 PLT Parameters

• PLT Count

The analyzer obtains the number of platelet (PLT) by measuring the corresponding

electrical pulses of RBC directly. The unit is 10

9

/L.

Section 5 Principles of Operation

• MPV

The mean platelet volume (MPV) is derived from the PLT histogram after the PLT count

has been determined. The unit is fL.

• PDW

The platelet distribution width (PDW) is a measure of the heterogeneity of the PLT

population. It is expressed as the PLT volume distribution. (10 GSD).

• PCT

The PCT is calculated as follows. The unit of PLT is 10

9

/L. The unit of MPV is fL.

5.6 WOC, WIC functions and RRBC mode

The H50V analyzer determines the total white blood cell count using both impedance

(WIC) and laser-based flow cytometry (WOC). By default, the WOC optical channel is

used in all animal profiles, which means that the two scatter diagrams “Size” and “Diff”

are shown on the display. See Section 3.6 Test Interface.

For each measurement the analyzer compares between WIC and WOC counts. If a

significant difference is detected, the analyzer will flag it as a possible presence oflyse-

resistant red blood cells (RBCs). If this happens the sample should be re-analyzed in

RRBC mode, which involves a longer mixing time with Sheath reagent. See Section

6.7.1.

5.7 Principles of Reticulocyte Analysis

Reticulocytes are immature RBCs that exist in transition between nucleated RBCs and

mature RBCs. In contrast to mature RBCs, reticulocytes contain ribosomal RNA. The

RNA in the immature RBCs can be detected by laser after treatment with a dedicated

staining solution.

Illuminated with the polarized light, the stained precipitate will strengthen the scattered

light on a wide-angle direction. Reticulocytes are visualized in two scatter plots by

detecting signals in super wide angle compared to small and high angle.

In Figure 5-9, Red events represent red blood cells (RBC), Black events represent white

blood cells (WBC) and Green events represent reticulocytes (RET). When

reticulocytes are present, they appear as a cluster above the mature RBCs.

Section 5 Principles of Operation

Figure 5-9 RETIC scatter plot

5.7.1 RETIC_ABS

RETIC_ABS is the concentration of RETIC. It corresponds to the ratio of the RETIC

to the RBC multiplied by the RBC concentration.

RETIC_ABS = RET × RBC

5.7.2 IRF

IRF (Immature Reticulocyte Fraction) contain more RNA than mature reticulocytes,

which result in a stronger light scatter signal. The immature reticulocytes are reported

as a fraction (or percent) ofthe reticulocytes.

IRF = (IRFPo int s /RETICPo int s) × 100%

NOTE

The reticulocyte test mode might not be available in all analyzer models or relevant

in all animal profiles. Contact your local Boule representative for more information.

When enabled in the H50V analyzer the RETICS method can be used as guideline

in anemia investigations. If elevated reticulocyte counts are detected, it is

recommended to confirm with manual blood smear count.

Section 6 Daily Operation

6 Daily Operation

6.1 Overview

This section describes the procedures of daily operation from Startup to Shutdown

and explains the process of different modes of sample analysis in detail.

Daily Operation Flow Chart as follows:

CAUTION

Operator must have basic laboratory skills and be aware of good laboratory

practice.

Preparations

Startup

Quality Control

Sample Preparation

Data Input

Sample Measurement

Result Query and Output

Statistical Analysis

Shutdown

Section 6 Daily Operation

6.2 Preparations

Check the analyzer for the following steps before startup.

Check the Waste Container

• The waste should be processed properly and cleaned up before startup every day.

Check Reagents, Tubing and Power connection

• Ensure that Diluent, Lyse, Detergent and Sheath meet the test requirements.

• Ensure that the tubing of reagents and waste are properly connected, and in a

relaxed state.

• Ensure that the power connection of the analyzer and computer are reliable.

Check the Printer

• Ensure that installation is proper, and that paper is stocked.

6.3 Startup

1. Turn On the power switch located on the left side of the analyzer. The status

indicator on the front panel turns orange.

The analyzer program starts and enters the startup interface. The components of the

system are checked, and the liquid system is rinsed. The automatic sequence lasts about

four minutes. The status indicator on the start plate turns green after initiation.

2. Enter Username and Password using the virtual popup keyboard.

Default account and password with all user rights is admin. To log in with another

account enter the Setup interface and select Log off.

3. After Startup the Test interface opens. See Figure 6- 1.

Section 6 Daily Operation

Figure 6-1 Test Interface

6.3.1 Background Test

When startup is complete, perform a background test to make sure that the analyzer

and reagents are within range.

1. In the Test interface, select Mode Switch.

2. Set Counting Mode to BackGround.

3.

Select OK.

4. Run a Background test and confirm that the test results are within the acceptable

range.

Background Count

Parameter

Acceptable range

WBC

≤0.20×10

9

/L

RBC

≤0.02×10

12

/L

HGB

≤0.1g /dL

PLT

≤10.0×10

9

/L

If the Background test results are above the limits, repeat the above procedure until it

is within range, before proceeding with clinical samples.

The background test can be set to run automatically after startup, refer to Section 9.1.2

Maintenance Setup for details.

Section 6 Daily Operation

6.4 Quality Control

Perform Quality Control before proceeding with clinical samples to ensure accurate

results. Refer to Section 7 Quality Control.

6.5 Collection of Blood Samples

WARNING

As there are no assurance of the absence of HIV, Hepatitis B or C viruses or other

infectious agents in animal blood samples, controls, calibrators and waste, these

products should be handled as potentially biohazardous. Refer to local regulations

and established laboratory protocol for handling biohazardous material. This

should include use of gloves, lab coat and eye protection.

CAUTION

Blood collection and disposal should be performed according to local and national

environmental regulations or the laboratory’s requirements.

Ensure that the full procedure of blood collection is clean and contamination-free.

Venous blood samples should be collected in EDTA-K

2

·2H

2

O tubes in sufficient

quantity and be gently mixed after sampling to obtain accurate results. Follow the

recommendation of the EDTA tube supplier.

Do not shake the sample tube vigorously.

The sample should be kept at room temperature. Excessive cold or heat could cause

erroneous results.

Samples drawn in an open tube or vacuum tube should be analyzed between 15

minutes and 4 hours after sampling for most accurate results.

6.5.1 Whole blood collection

Collect whole blood samples by venipuncture and store them in clean sample tubes

which contains EDTA-K

2

·2H

2

O (1.5 – 2.2mg/mL). EDTA-K

2

·2H

2

O maintain WBC

and RBC configuration and inhibits PLT aggregation. Gently turn the tube around 5-10

times to ensure the sample is well mixed.

6.5.2 Pre-dilute sample preparation

1 ．In the Test interface, select Mode Switch.

2 ．Set Counting Mode to Rout. Blood.

Section 6 Daily Operation

3 ．Set Blood Mode to Pre-dilute.

4 ．Set Analysis Mode to CBC+5Diff.

5 ．Place a clean test tube under the sample probe and select Dispense.

The system automatically drains 500μL diluent from aspiration probe. It is

recommended to put the test tube close to the sample probe, to avoid bubbles or spill.

6 ．Add 20uL peripheral blood into the test tube filled with diluent and mix well.

CAUTION

Prevent the collected diluent from being contaminated by dust as it may cause

analytical error.

Let the mixture of peripheral blood and diluent stand for 3 minutes, mix again and

only thereafter analyze the sample.

Analyze the sample within 30 minutes after dilution, to ensure reliable analysis

results.

Each laboratory should evaluate the stability of the results in diluent mode

according to their own established laboratory protocol.

6.5.3 Blood tube mixer

The H50V analyzer comes with a mixer that uniformly mixes samples before analysis.

1. In the Setup interface, select Maint.Set.

2. Select Sample Mixer: On and then OK. The mixer starts to rotate.

3. Select Sample Mixer: Off and then OK. The mixer will stop.

6.6 Data input

Sample information can be added either before or after sample analysis.

Before sample analysis:

4. In the Test interface, select Next sample to add sample information.

5. Select desired input box and use the virtual keyboard to add information.

After sample analysis:

1. In the Data interface, choose Sample ID and select Edit Info to access the

dialogue box to edit the sample information.

2. Select OK to save the edit or Cancel to abandon the edit.

When a sample is under audit it cannot be edited. To edit, cancel the audit first.

Section 6 Daily Operation

If needed, connect an external PS2 or USB interface keyboard to enter information. The

following data fields are available:

ID: only accepts numbers. If left blank, the analyzer automatically creates a new Serial

number (SN) by increasing the last digit in the SN by one.

Case ID: case number.

BarCode: barcode number.

Pat.Name: name of patient.

Master: name of owner.

Age: year, month, day, and hour can be selected.

Tel.: phone number of owner.

Sampling time: blood sample collection time.

Gender: male or female, the default is blank if not selected.

Sender: name or code of sender.

Sending time: time of sending sample to the department.

NOTE

SN 0 is used for the background test. Do

samples.

not enter 0

when processing clinical

CAUTION

Each sample has a corresponding identification number. Keep track.

Section 6 Daily Operation

6.7 Running a Sample test

6.7.1 Sample mode

1. In the Test interface, select Mode Switch.

2. Set Counting Mode to Rout.blood to perform a routine blood test.

3. Set Blood Mode to Whole blood or Pre-dilute depending on how the blood

sample was prepared.

4. Set Analysis Mode to CBC+5Diff.

Only use CBC+5Diff+RRBC if the analyzer displays a warning for Resistant red blood

cells (RRBC) after performing a test in CBC+5Diff mode.

NOTE

CBC+5Diff can be chosen for both Whole Blood and Pre-dilute samples.

CBC+5Diff+RRBC is used to eliminate the interference from resistant red blood

cells. When RRBC alarm appears, switch analysis mode to CBC+5Diff+RRBC

and repeat the sample test. If WBC total number is far less compared with the

first count, it shows that this specimen contains resistant red blood cells.

6.7.2 Animal settings

The analyzer comes with predefined profile settings for several animal species. These

include Dog, Cat, Horse, Rat, Mouse, Rabbit, Monkey, Cow, Pig, Buffalo, S heep,

Camel and Goat, Cus 1, Cus 2 and SYS. SYS is used for Quality Control and

Calibration.

1 ．In the Test interface, select Animal.

2 ．Choose animal species and select OK to confirm.

3 ．Proceed to sample testing.

Section 6 Daily Operation

6.7.3 Limit

The analyzer comes with predefined profile settings for several animal species,

indicating normal reference range for healthy animals. The settings can be modified and

saved to suit local requirements.

1 ．In the Setup interface, select Limit. See Figure 6-2.

Figure 6-2 Limits

2 ．In the Limit interface, select Animal to choose profile settings.

3 ．Select OK to confirm patient group.

4 ．Select the desired value under Lower or Upper to change the limits for individual

parameters.

5 ．Use backspace to remove the former value and type in the new value.

6 ．Select Save to save the new setting for the chosen patient group.

Other functions in the Limit interface:

• To revert to the factory settings, select the intended group and then select

Default.

• To export current group limits, select Export.

• To print current group limits, select Print.

• Select Return to go back to Setup interface.

Section 6 Daily Operation

6.7.4 Counting and Analysis

WARNING

The sharp sample probe contains residues of clinical specimens, controls, or

calibrators. Consider the sample probe as infectious and avoid direct contact.

CAUTION

Use recommended vacuum blood tubes, centrifuge tubes, capillary tubes and other

disposable products when collecting the blood sample.

NOTE

Do not reuse disposable items.

Ensure that the entered ID number corresponds to the sample.

1. Ensure that the sample is well mixed.

Gently invert the blood sample 10- 15 times or use the sample mixer, refer to Section

6.5.3 for details. If an Eppendorf or micro tube is used for sampling, flick the tube

with a finger to mix.

2. Hold the sample under the sample probe in an upright position.

3. Press the start plate to aspirate sample.

The sample probe will move up when sample aspiration is finished. Do not remove

sample before aspiration is complete. Incomplete aspiration will cause erroneous

results.

4. Results are automatically saved.

6.8 Data Query

After each run, results are automatically saved in a database that can store

approximately 200 000 sample measurements including results, scatter diagrams and

two histograms per sample. All results, scatter diagrams and histograms stored in the

database can be reviewed through query and statistics.

Section 6 Daily Operation

6.8.1 Data Query

1. In the Data interface, select Query. See Figure 6-3.

Figure 6-3 Data Interface

2. The Query dialogue box opens.

3. Choose between a Quick query or a Conditional query.

For a Quick query choose to display current Unaudited samples, Unprinted samples

or select No transmitted to view not transmitted samples.

Use the Conditional query to search for a specific run by entering the specified ID,

Master, Case ID or Pat.Name. A query can also be limited to a range of Sample

number or Test date. The conditional query can be further tailored by using Sample

State.

6.8.2 Data Selection

1. Enter the Data interface.

2. Tap the screen to select a sample to view. Selected samples will have an * in front

of the sample ID. See Figure 6-3.

3. In the Data interface, select Graph Review to view detailed data and graphs. See

Figure 6-4.

Use Pre. record and Next record to scroll between samples in the Graph Review

interface.

Section 6 Daily Operation

Figure 6-4 Graph Review

6.8.3 Data Export

1. In the Data interface, select Export to access the Export dialogue box.

2. Set Range to either Chosen record or All records, tick relevant items in Content.

3. Insert the USB stick before exporting. Select OK to start the export. The exported

data is in Excel format. Select Cancel to cancel the export.

6.8.4 Data Deletion

1. In the Data interface, select individual samples or multiple samples for deletion.

2. Select Delete to permanently remove data stored in the analyzer.

NOTE

Be aware that once the data is deleted, it can NOT be recovered. Operate with

caution.

Section 6 Daily Operation

6.9 Reticulocyte Analysis

The H50V Analyzer includes an optional mode to analyze presence of immature red

blood cells, reticulocytes, in blood samples. The retic mode measurement function may

not be locally available or need to be enabled by an authorized service technician prior

to use. Contact your local Boule representative for further information.

Reticulocyte samples are prepared from blood samples diluted and dyed with the

reticulocyte staining reagent, refer to Section 6.9.1. The test result of a reticulocyte

sample is Reticulocyte rate, Reticulocyte absolute value and IRF.

6.9.1 Preparation of Reticulocyte samples

Prepare a sample for Retics analysis from a fresh blood sample, maximum 8 hours after

collection, refer to Section 6.5.

1 ． Gently invert the blood sample 10-15 times. If an Eppendorf or micro tube is used

for sampling, flick the tube with a finger to mix.

2 ．Add 20µL of whole blood directly into the liquid of one tube of H50V Reticulocyte

stain.

3 ．Place the H50V Reticulocyte stain tube containing the sample, in a dry incubator

with a temperature of 37℃ for 15 minutes.

4 ．Take out the sample and gently invert it 10-15 times before analysis.

5 ．Analyze the sample in Retics test mode, within 10 minutes.

Section 6 Daily Operation

6.9.2 Reticulocyte background test

1. In the Test interface, select Mode Switch.

2. Set Counting Mode to Retic back. See Figure 6-5.

Figure 6-5 Reticulocyte Background

3. Perform a Retic background test to get the numerical value of the background

before proceeding with measurements of samples.

If the Retic background results are above 0.5 × 10

9

/L repeat the above procedure until

it is within range before proceeding with measurements of samples.

6.9.3 Reticulocyte test

A reticulocyte measurement can be performed and saved on its own, or by adding the

reticulocyte measurement result to a corresponding sample already collected in regular

CBC-5Diff mode.

To collect a Retics sample, do the following:

1. In the Test interface, select Mode Switch.

2. Set Counting Mode to Retic test to enter the reticulocyte test interface See Figure

6-6.

3. Aspirate a Retics sample by pressing the Start plate.

4. Enter a new ID and RBC value. The RBC value is used for calculating Retics%

Section 6 Daily Operation

Figure 6-6 Reticulocyte Test interface

To collect and add Retics data to an existing sample, do the following:

1. In the Test interface, select Mode Switch.

2. Set Counting Mode to Retic test to enter the reticulocyte test interface See Figure

6-6.

3. In Data interface, select a sample previously collected in CBC-5Diff mode.

4. Select Graph review.

5. Press the Start plate. A pop-up dialogue box opens.

6. The pop-up dialogue box shows the ID and RBC value of the chosen CBC-5Diff

mode measurement. Make sure the correct sample is selected. Data can be

overwritten.

7. Select OK. Sample is aspirated and measurement values added to the chosen

sample.

NOTE

Avoid contact of skin and clothes with Reticulocyte staining reagent. New

methylene blue contained in the reagent can result in skin, clothes, and other

surfaces pollution.

The reticulocyte test mode might not be available in all analyzer models or relevant

in all animal profiles.

6.10 CV Value and Trend graph

1. To check the Coefficient of Variation (CV) value, repeat a Sample test with the

Section 6 Daily Operation

control material or the same blood sample 11 times.

2. In the Data interface, remove the first test result and select the remaining 10

results.

3. In the Data interface, select CV to see the CV value or select Trend graph to see

the trend graph of the parameters.

6.11 Shutdown and Logout

The Shutdown procedure should be performed before turning off the power to clean

sample cups and tubing. The Shutdown procedure should be performed as a minimum

once per week.

Shutdown Procedure

1. In the Setup interface, select Shutdown and OK.

2. The analyzer asks if soaking shall be performed. Select OK or Cancel.

Soaking, also referred to as Probe Cleaning with Soak, is a cleaning procedure

performed by aspirating H50V Probe Cleaner. Perform soaking after processing 25

samples, or as a minimum once a week if less samples are analyzed. See Section 9

Maintenance.

3. Shut off the analyzer or leave it in Standby mode.

4. Alternatively, in the Setup interface, select Logout and select OK.

Log out Procedure

1. In the Setup interface, select Logout and OK.

2. Enter new username and password.

3. Select OK to log in.

CAUTION

Failing to complete the Shutdown procedure properly may result in data loss

and abnormal boot.

Section 7 Quality Control

7 Quality Control

7.1 Overview

Perform Quality Control (QC) regularly to maintain the analyzer precision and

eliminate system errors. The analyzer provides four QC methods, which are Levey-

Jennings (L-J) QC mode, X-B QC mode, X-R QC mode and X QC mode.

L-J QC mode is the default mode accessed via the QC interface while remaining QC

methods are accessed via the Setup interface.

Perform Quality Control with the recommended control materials when:

• the daily startup procedure is completed.

• the reagent lot number changes.

• the analyzer has been calibrated.

• a maintenance has been performed or components have been replaced.

• the laboratory or the clinical QC protocol recommend it.

• abnormal parameter values are suspected.

WARNING

As there are no assurances ofthe absence of HIV, Hepatitis B or C viruses or other

infectious agents in animal blood samples, controls, calibrators and waste, these

products should be handled as potentially biohazardous. Refer to local regulations

and established laboratory protocol for handling biohazardous materials. This

should include use of gloves, lab coat and eye protection.

CAUTION

Only use controls authorized by Boule.

The operator should be thoroughly familiar with the analyzer and the control

procedure before analyzing the control.

Follow the instructions for use and storage of the control.

Ensure that the control container is undamaged before use.

Ensure that the control is brought to room temperature and properly mixed before

use.

Do not use the control beyond the stated expiration date.

Do not use the control if deterioration is suspected.

Do not pre-mix the control on a mechanical mixer.

Section 7 Quality Control

Wipe the aspiration probe with a clean, dry lint-free absorbent cloth before

each control run. Not following this technique will impact control accuracy.

Check the value difference by comparing the current batch and the previous batch

of control material.

7.2 Quality Control Options

L-J QC

L-J QC (Levey-Jennings graph) is a visual QC method with which the operator can plot

a QC value directly in a graph after getting the Mean, Standard Deviation (SD) and

Coefficient of Variation (CV).

__

The Mean ( X ), SD and CV are derived from the following formulas.

X-B QC

X-B QC is a moving average method. It is based on the principle that, the RBC count

varies due to blood concentration, blood pathology, and technical factors, while the

hemoglobin content, expressed as g/L, is hardly affected. Accordingly, the quality

control of samples is performed by examining the value of Mean Cell Volume (MCV),

Mean Cell Hemoglobin (MCH) and Mean Cell Hemoglobin Concentration (MCHC).

X-R QC

In X-R QC method, X indicates the mean value, R indicates the range of values. The X

graph is mainly used to judge if the mean value reaches the required level. The R graph

is mainly used to judge if the value range reaches the required level.

X QC

X QC is a variant ofthe X-R QC. The difference is that the control datapoint in the X

graph indicates the mean value of two results rather than one result, and based on this

calculates the Mean, the SD and the CV.

Section 7 Quality Control

7.3 Levey-Jennings QC

7.3.1 L-J QC Setup

1. Select the QC interface to enter the L-J QC interface. See Figure 7-1.

Figure 7-1 L-J QC Interface

2. Select Setup to enter the L-J QC setup interface. See Figure 7-2.

There are 14 different QC group sets available. The operator can set several groups if

needed. Select Edit to make changes to a selected group, select Delete to delete the

selected group, select Emptied to delete all groups.

Section 7 Quality Control

Figure 7-2 L-J QC Setup

3. Select New to set up a new group of QC. See Figure 7-3.

Figure 7-3 New QC Group

The L-J QC method is based on QC control material. Enter the relevant information.

Information that can be edited is Lot number, QC material type, QC case ID, Level,

Runaway mode, Valid period, Reference, and SD. Enter the SD values under

Limit(#).

Section 7 Quality Control

The Reference is the standard value of the QC count. The SD provides the allowed

deviation range. Note that the SD cannot be greater than the reference, or it cannot be

saved in the database.

NOTE

Control Assay sheets provides WBC reference values using both WOC and WIC

counting methods. The H50V analyzer is set to use WOC counting, hence enter the

WOC reference and SD values in QC control.

4. Select Limit setup to set up the SD. Choose to have SD calculated either as an

absolute value or as a percentage.

5. Select Return and then OK in the popup dialogue box.

To run a QC test:

1. In the QC interface, select Setup.

2. Select one QC group and select Return to go back to the QC interface to run a QC

test.

3. Ensure that the control sample is well mixed and handled according to the

manufacturer’s instructions, refer to Section 8.3.3 for details.

4. Hold the sample under the sample probe in an upright position.

5. Press the start plate to aspirate sample.

The sample probe will move up when sample aspiration is finished. Do not remove

the control before aspiration is complete. Incomplete aspiration will cause erroneous

results.

Section 7 Quality Control

7.3.2 L-J QC Graph

QC measurements are viewed in the L-J QC graph.

1. In the QC interface, select QC Graph, to view the results. See Figure 7-4.

Figure 7-4 L-J QC Graph

2. If a data point is not within the control range, choose this data point and select

Outlier. Identify the reason for the outlier and select OK to save your settings.

QC Graph features

• Each screen displays the QC chart for two parameters at a time, with the Mean, SD

and CV of each parameter shown on the right-hand side. Use the arrows to scroll

through the parameters.

• The graph displays the number of runs of the QC count on the horizontal axis and

the measured result values of the QC count on the vertical axis.

• Every parameter graph displays 20 data points. Use the arrows to scroll through

the data points.

• The center line of the graphs corresponds to the Reference value for that parameter.

• The upper and lower line on every parameter graph corresponds to the Reference

value ± SD.

If a control value/data point falls in the area between the upper and the lower limits of

the corresponding graph, it means that the data point is within the control range. If not,

the data point is outside the control range. Each QC graph can accommodate up to 100

data points.

Section 7 Quality Control

7.3.3 L-J QC List

1. In the QC interface, select QC list to view the test sample data. See Figure 7-5.

Figure 7-5 L-J QC List

All generated QC test results are saved in the QC list. Use the arrows to navigate

between the test results. A maximum 100 QC test results can be reviewed in the QC

list. Limit(#), represent SD. Note that the values for Reference and Limit(#), shown

in the QC list interface are the values that were entered during set up.

7.4 X-B QC

X-B QC is different to the other QC methods. That is, QC control material is not used,

and only three parameters, the MCV, MCH and MCHC are managed in this method.

7.4.1 X-B QC Edit

1. In the Setup interface, select X-B QC. A popup dialogue box opens.

2. Select XB setup to edit the setup.

3. Choose the number of samples to be used in Sample number. The available range

is between 20 and 200.

4. Manually enter the Reference and the SD values of MCV, MCH and MCHC in the

corresponding Reference and Limit(#) columns.

5. Manually enter the Sample validity of RBC, MCV, MCH and MCHC in the Lower

and Upper columns. This provides the range where the SD of the RBC, MCV,

MCH and MCHC are valid.

Section 7 Quality Control

The Reference is the standard value of the QC count. The Limit(#) corresponds to SD

and indicates the allowable deviation range. Note that the Limit cannot be greater than

the reference, otherwise, the new SD cannot be saved in the database.

6. Select Limit setup in the XB Setup interface to choose Absolute value or

Percentage.

7. When setup is complete select Return and OK to save the settings in the popup

dialogue.

7.4.2 X-B QC Run

X-B QC is a QC method that does not use QC control materials. The basic method for

measuring the X-B QC is the floating mean method.

1. In the Setup interface, select the X-B QC and then select XB setup. Use the option

On to start the X-B QC run, and Off to stop the X-B QC run.

2. Select On to run the X-B QC.

Sample number controls the number of samples in one group. For example, if there

are 20 samples in one group, the analyzer will perform X-B QC testing 20 times.

7.4.3 X-B QC Review

Review the QC results of the three parameters through the QC graph review, and the

QC list review.

QC graph review

1. In the Setup interface, select the X-B QC and then select XB graph.

Data points of the MCV, MCH and MCHC are plotted in the QC graph after a set of

samples have been tested. The X-B QC result is automatically calculated and displayed

in the graph.

The three graphs display MCV, MCH and MCHC. The graphs are automatically

updated after each set of QC counting. Use the arrows to navigate between the test

results. Each data point in a graph has the corresponding date and time. The displayed

date and time are subject to the date and time of final data within one group.

QC Graph features

• The screen displays QC charts for three parameters, with the Mean, SD and CV of

each parameter on the right-hand side.

• The graph displays the number of runs of the QC count on the horizontal axis, and

the obtained result value of the QC count on the vertical axis.

• Every parameter graph displays 20 data points. Use the arrows to scroll through

the data points.

Section 7 Quality Control

• The center line of the graphs corresponds to the Reference value for that parameter.

• The upper and lower line on every parameter graph correspond to the Reference

value ± SD.

If a control value falls in the area between upper and lower limit of the corresponding

graph, it means that the data point is within the control range. If not, the data point is

outside the control range.

QC list review

1. In the Setup interface, select the X-B QC.

2. Select X-B Graph and then QC list.

The average of a set of data is saved after testing. Use the arrows to navigate between

the test results. The Reference and the Limit(#) values shown in this interface are the

values entered during setup.

Select Delete to delete selected test results. Select Emptied to delete all results. Select

Export to export all data. Select Return to go back to the X-B graph interface.

7.5 X-R QC

X-R QC method, or the mean-range QC method, uses QC control material. The analyzer

creates an alarm when the QC count result is invalid when a background test is run.

7.5.1 X-R QC Setup

1. In the Setup interface, select X-R QC interface. A popup dialogue box opens.

2. In the X-R QC interface, select Setup to enter the QC Setup interface.

The functions in the X-R QC Setup interface are:

• New to create a new QC set.

• Delete to delete selected test results.

• Emptied to delete all results.

• Edit to modify QC information which has already been set up.

3. Select New to create a new QC set. A popup dialogue box will open.

4. Enter QC control material information related to Lot, QC material type, QC Case

ID, Level and Valid period.

5. Select OK to save the information.

6. Select Return to go back to the X-R QC interface to perform the QC test.

To run a QC test:

1. In the X-R QC interface, select Setup.

Section 7 Quality Control

2. Select one QC group and select Return to go back to the X-R QC interface to run

a QC test.

3. Ensure that the control sample is well mixed and handled according to the

manufacturer’s instructions, refer to Section 8.3 for details.

4. Hold the sample under the sample probe in an upright position.

5. Press the start plate to aspirate sample.

The sample probe will move up when sample aspiration is finished. Do not remove the

control before aspiration is complete. Incomplete aspiration will cause erroneous results.

A maximum of 100 sets of QC data can be tested. The QC run interface displays two

QC test results separately, and automatically calculates twice the mean and the range

after finishing the second QC count. The mean of the two QC test data is one set of data.

7.5.2 X-R QC Graph

1. In the Setup interface, select X-R QC and then select QC graph, see Figure 7-9.

Use the arrows to navigate between the test results. Select Return to go back to the X-

R QC interface.

In the X-R QC Graph interface, there are two different graphs for each parameter, the

X graph, and the R graph. The X graph displays the mean value results while the R

graph displays the range results. If the Level Normal is selected during setup and the

QC test is performed twice, the data point in the X graph will correspond to that level.

The data points for the range are shown in the corresponding R graph.

X-R graph features

• The graph displays the number of runs of the QC count on the horizontal axis and

the measured result values of the QC count on the vertical axis.

• Each parameter graph can display 100 data points. Use the arrows to scroll through

the data points.

• The center line of each parameter X graph corresponds to X, the overall mean value

of the QC results.

• The upper line of each parameter X graph corresponds to X Upper limit ＝X＋A×R.

• The lower line of each parameter X graph corresponds to X Lower limit ＝X -

A×R.

• The center line of each parameter R graph corresponds to R, the mean value of the

QC result range.

• The upper line of each R parameter graph corresponds to R upper limit ＝B×R.

• The lower line of every R parameter graph corresponds to R lower limit ＝C×R.

If a control data point falls in the area between the upper and the lower lines, it means

that the data point is within the control range. If not, the data point is outside the control

range.

Section 7 Quality Control

7.5.3 X-R QC List

1. In the X-R QC interface select Setup.

2. In the Setup interface, select one QC group and select Return.

3. In the X-R QC interface, select QC list. The displayed data is the selected QC data.

A maximum of 100 data results can be reviewed in the QC list. Use the arrows to

navigate between test results. The QC data is updated after running two new controls.

The data displayed in the QC list is the average of the two QC count results.

The difference between X-R QC and L-J QC Query is that the X-R QC interface

displays three QC results that includes the mean value and the range. First page of the

first two columns is the total mean and average range in the X-R QC test.

7.6 X QC

The X QC method is used with QC control material. It is possible to generate up to 24

QC parameters depending on need. The method provides QC documents for high,

normal, and low Control material for saving.

7.6.1 X QC Setup

1. In the Setup interface, select X QC and then select Setup.

The functions in the X QC Setup interface are:

• New to create a new QC set.

• Delete to delete selected test results.

• Emptied to delete all results.

• Edit to modify QC information which has already been set up.

2. Select New to create a new QC set and enter the relevant information.

Information that can be edited is Lot number, QC material type, QC case ID, Level,

Runaway mode, Valid period, Reference, and S D. S D values are e ntered under

Limit(#).

3. Select Limit setup to choose to present SD with the Absolute value or the

Percentage value method.

The QC run interface displays two QC test results separately and automatically

calculates twice the mean and the range after finishing the second QC count. The mean

of two QC test data is one set of data.

Section 7 Quality Control

7.6.2 X QC Graph

1. In the X QC interface, select QC Graph.

The results of up to 24 parameters can be viewed via the QC graph. The difference

between X QC and L-J QC is that the data point on the X QC Graph indicates the mean

value of two QC results.

QC graph features

• The graph displays the number of runs of the QC count on the horizontal axis, and

the obtained result value of the QC count on the vertical axis.

• Each parameter graph can display 100 data points. Use the arrows to scroll through

the data points.

• The center line of the graphs corresponds to the Reference value for that parameter.

• The upper and lower line on every parameter graph correspond to the Reference

value ± SD.

If a control result falls in the area between the upper and the lower lines, it means the

data point is within the control range. If not, the data point is outside the control range.

7.6.3 X QC List

1. In the X QC interface, select Setup.

2. In the Setup interface, select a QC group and then select Return.

3. In the X QC interface, select QC list. The displayed data is the selected QC data

Select Delete to delete selected test results. Select Emptied to delete all results. Select

Edit to modify QC information which has already been set up.

Section 8 Calibration

8 Calibration

8.1 Overview

Calibration is used to establish a reference point that assists the analyzer to produce

accurate results. The H50V analyzer has been factory calibrated prior to shipment.

However, good laboratory practice requires regular checks, and recalibration of measured

parameters if needed. Only authorized operators with an Administrator account can update

or change calibration factors.

The analyzer provides three calibration modes: Standard, Blood and Manual.

Standard calibration mode is recommended when using a Calibrator to calibrate all

animal profiles with same adjustments. Blood calibration mode can be used to calibrate

each profile individually, should there be a need for it. Use Manual calibration mode

to manually set adjustment, to all or each profile separately.

WARNING

As there are no assurances ofthe absence of HIV, Hepatitis B or C viruses or other

infectious agents in blood samples, controls, and calibrators these products should

be handled as potentially biohazardous. Refer to local regulations and established

laboratory protocol for handling biohazardous materials.

CAUTION

Only use calibrators authorized by Boule.

Only adjust user calibration, do not adjust factory set Calibration factors.

The operator should be thoroughly familiar with the analyzer and the calibration

procedure before performing calibration.

Follow the instructions for use and storage of the calibrators.

Ensure that the calibrator container is undamaged before use.

Ensure that the calibrators are brought to room temperature and properly mixed

before use.

Do not use the calibrators beyond the stated expiration date.

Do not use the calibrator if deterioration is suspected.

Do not pre-mix the calibrator on a mechanical mixer.

Wipe the aspiration probe with a clean, dry lint-free absorbent cloth before

each calibrator run. Not following this technique will impact the accuracy.

Ensure that the analyzer is in good working condition and that the precision meets

the requirements before calibration.

Do not use the analyzer for clinical samples unless all the parameters are accurately

Section 8 Calibration

calibrated.

8.2 Calibration Frequency

To ensure precision and obtain reliable test results, the parameters (WBC, RBC, PLT,

HGB and MCV) should be calibrated in the following situations:

• The working environment has significantly changed.

• Test results of one or multiple parameters are not accurate.

• A major component that affects the measurement is replaced.

• If the analyzer is not used for a long time.

• If the laboratory or the clinical protocol requires it.

• Quality control present deviating results.

MCV and HCT are parameters relative to each other, thus one can be obtained from a

given value of the other. Only MCV can be calibrated by the analyzer. Usually, the

manufacturer provides the value for MCV and HCT at the same time.

8.3 Handling of Calibrator and Control

8.3.1 Summary and Principle

The Calibrator and Control are stable whole blood preparations that can be used to

verify and adjust calibration ofthe H50V veterinary hematology analyzer.

8.3.2 Indication of deterioration

After mixing, Calibrator and Control should be similar in appearance to fresh whole

blood. In unmixed vials, the supernatant may appear cloudy and reddish; this is normal.

Other discoloration, very dark red supernatant, or unacceptable results may indicate

deterioration. Do not use the Calibrator or Control if deterioration is suspected.

8.3.3 Mixing and handling of Calibrator and Control

1. Remove the vials from the refrigerator and allow to warm to room temperature (15

– 30°C) for 15 minutes before mixing.

2. To mix, hold the vial horizontally between the palms ofthe hands. Do not pre-mix

on a mechanical mixer.

a) Roll the vial back and forth for 20 – 30 seconds; occasionally invert the vial.

Mix vigorously but do not shake.

b) Continue to mix in this manner until the red cells are completely suspended.

Vials stored for a long time may require extra mixing.

c) Gently invert the vial 8 – 10 times immediately before running each sample.

3. After sampling, carefully wipe the vial rim and cap with a lint-free tissue and

replace the cap.

4. Return the vials to the refrigerator within 30 minutes of use.

Section 8 Calibration

8.4 Preparation

Before calibration, check the following:

1. Ensure that reagents are sufficient, uncontaminated, and not past the expiration

date.

2. Verify that analyzer maintenance and cleaning is current. Refer to Section 9.

3. Run a background test, refer to Section 6.3.1 for details. Make sure that results are

within the acceptable range.

Background Count

Parameter

Acceptable range

WBC

≤0.20x10

9

/L

RBC

≤0.02x10

12

/L

HGB

≤0.1g /dL

PLT

≤10.0x10

9

/L

4. Verify the precision by checking the Coefficient of Variation (CV) value.

a) Repeat a Sample test with the control material 11 times with the SYS profile.

b) In the Data interface, remove the first test result and select the remaining 10

results.

c) In the Data interface select CV to see the CV value or select Trend graph to

see the trend graph of parameters.

d) Make sure that CVs are within the acceptable range.

Coefficient of Variation (CV) value

Parameter

Range

CV

WBC

4.0 ×10

9

/L – 15.0×10

9

/L

≤3.0%

RBC

3.00 ×10

12

/L – 6.00×10

12

/L

≤2.0%

HGB

100 g/L – 180 g/L

≤2.0%

PLT

100 ×10

9

/L – 149×10

9

/L

150 ×10

9

/L – 500×10

9

/L

≤6.0%

≤5.0%

HCT /

35% – 50%

≤2.0%

MCV

70 fL – 120 fL

≤1.0%

Section 8 Calibration

8.5 Calibration Modes

8.5.1 Principles of the new Calibration coefficient

• Mean value = the sum of the values/the count of the values

• New calibration value = (reference value/mean value) × former calibration value

• If the new calibration value is <70%, consider it equal to 70%, if the new

calibration value is >130%, consider it equal to 130%

For example, if the reference value of PLT of the calibrator is 220, the former

calibration value is 103% and the mean value is 230, then the new calibration value is

New calibration value =103%×220/230=98.52%

8.5.2 Validation of Calibration coefficient

Follow these steps to validate the Calibration coefficient after calibration.

1. Run the calibrator three times, and check that the results are within the acceptable

range. Compare the mean value for each parameter to the assigned value. If the

difference is within range, calibration is optimal. If the difference is not within

range, recalibration may be needed.

2. It is recommended to run a minimum of three replicas of a control. Check that the

results are within the acceptable range.

NOTE

The acceptable range for the Calibration coefficient is 70% – 130%. If results

exceed the limit, then the maximum value in the limit range should be selected as

the new coefficient for calibration. If this occurs, the operator should identify the

reason and recalibrate. If the problem persists, contact your local Boule

representative.

8.5.3 Manual Calibration

1. Select Manual in the Cal interface. See Figure 8-1.

2. The analyzer will automatically switch the profile to SYS.

3. For each parameter enter its reference value under Reference and the average

obtained value under Test value.

4. Select New Cal% and the new Calibration coefficient is automatically calculated

for the corresponding parameter.

5. When leaving the Manual interface, the Select pop up menu will open.

6. Choose which profiles to update and select OK to save the new Calibration

coefficient.

Section 8 Calibration

If the Calibration coefficient has already been obtained simply type in the value for

each parameter under Cal% and select OK to save it. Refer to Section 8.5.1 for details.

Figure 8-1 Manual Calibration

NOTE

The analyzer can calibrate a selected parameter or all parameters ofWIC，WOC，　

RBC ，HGB ，MCV ，MPV, RDW_CV, RDW_SD, PLT and PDW.

Remember to save the calibration value before exiting the Cal interface.

7. Validate the Calibration coefficient after calibration. Refer to Section 8.5.2.

Section 8 Calibration

8.5.4 Standard Calibration

1. Select Standard in the Cal interface. See Figure 8-2.

2. The analyzer will automatically switch the profile to SYS.

Figure 8-2 Standard Calibration

3. Enter the Lot number according to the Assay sheet provided with the calibrator

under Lot.

4. Enter the reference value according to the Assay sheet provided with the calibrator

under Reference.

Reference values of parameters that do not need to be calibrated are left blank.

5. Hold the well-mixed calibrator under the sample probe and press the button on the

front to aspirate the calibrator.

The maximum number of tests that can be performed is 10. I t is recommended to

analyze at least three to five times. Make sure the sample is mixed between

measurements, refer to Section 8.3.3.

7. Deselect any unwanted calibrator tests in the list. Always deselect the first run.

The analyzer will automatically calculate the mean value from the chosen

calibrator tests.

8. The new Calibration coefficient is automatically calculated according to the

Section 8 Calibration

reference value of the calibrators and the computed mean value.

9. When leaving the Standard interface, the Select popup menu will open.

10. Choose which profiles to update and select OK to save the new Calibration

coefficient.

11. Select Print to print or select Export to export a backup of the calibration

coefficient data.

12. Validate the Calibration coefficient after calibration, refer to Section 8.5.2.

8.5.5 Blood Calibration

1. Select Blood in the Cal interface. See Figure 8-3.

2. The analyzer will automatically switch the profile to SYS.

Figure 8-3 Blood Calibration

2. Prepare five normal whole blood samples.

3. Obtain a mean value to be used as reference value by running each of the prepared

samples at least five times on other analyzers or by other reference method.

4. Select the Case ID1 sample and perform sample test on the H50V analyzer. Repeat

the counting between five to ten times to get the mean value. Continue in the same

manner with the Case ID2 sample, and so on. As a minimum, run five tests for

each sample.

5. The analyzer adds the measured values and calculates the average of the

parameters. The system automatically calculates a new Calibration coefficient

based on the reference value, the mean value, and the former Calibration

coefficient.

Section 8 Calibration

6. Select OK to save the new calibration coefficient.

7. When leaving the Blood interface, the Select pop up menu will open.

8. Choose which profiles to update and select OK to save the new Calibration

coefficient.

9. Select Print to print or select Export to export a backup of Calibration coefficient

data

10. Validate the Calibration coefficient after calibration, refer to Section 8.5.2.

NOTE

Remember to save the results before exiting the Cal interface.

Section 9 Maintenance

9 Maintenance

Routine care and regular maintenance are essential to keep the analyzer at its best,

extend its lifetime, and to minimize system problems.

Routine maintenance should be performed by the operator daily to weekly. Intermittent

maintenance should be performed by the operator when needed. Additional yearly

maintenance should be performed by trained service engineer.

WARNING

As there are no assurances ofthe absence of HIV, Hepatitis B or C viruses or other

infectious agents in animal blood samples, controls, calibrators and waste, these

products should be handled as potentially biohazardous. Refer to local regulations

and established laboratory protocol for handling biohazardous materials. This

should include use of gloves, lab coat and eye protection.

CAUTION

Maintain and follow cleaning procedures. Failing to do so could result in erroneous

results.

9.1 Routine Maintenance

The table below summarizes the routine maintenance procedures that should be done

by the operator.

Type of maintenance

Recommended frequency

Startup Daily to weekly

Probe Cleaning with Soak

Daily to weekly

Shutdown

Daily to weekly

Surface Maintenance

When needed

Sample Probe Cleaning (exterior) When needed

To minimize system problems:

• Perform Shutdown and Startup as a minimum once a week.

• Turn Auto Soak on. The system will automatically ask for Probe Cleaning with

Soak to be performed after processing a specified number of samples. 25 is the

recommended number of cycles. See Section 9.1.2 Maintenance Setup.

• Perform Probe Cleaning with Soak, as a minimum once a week and when prompted

by the system.

Section 9 Maintenance

• Some specimens, for example feline, are more prone to form clots. Adjust

maintenance intervals according to the local laboratory protocol.

9.1.1 Maintenance Procedures

Startup

The analyzer goes through an automatic self-test and cleaning procedure. For details,

refer to Section 6.3 Startup.

WARNING

Probe cleaner is strongly alkaline. Do not let it contact the skin or clothes. If this

happens, rinse the skin and clothes immediately with plenty of water.

Probe Cleaning with Soak

Cleaning with H50V Probe Cleaner aspirated through sample probe. The function is

also referred to as Soak. When prompted by software, aspirate H50V Probe Cleaner

through sample probe. If the volume in the Probe Cleaner bottle is too low for the needle

to aspirate, transfer the Probe Cleaner into a smaller tube.

It is recommended to perform Probe Cleaning with Soak in any of these three ways:

• In combination with Shutdown. When asked by interface to perform Soak, select

OK.

• When prompted by system. Perform Probe Cleaning with Soak, once a week or

when 25 samples have been processed. When asked by interface to perform Probe

Cleaning with Soak, select OK.

• From Test interface lower function buttons, select Soak, to perform a soaking of

the whole system.

Auto Prime

The analyzer includes an auto prime cleaning program. The frequency of the Auto

prime can be adjusted depending on number of samples analyzed, refer to Section 9.1.2

Maintenance Setup. After the Auto prime, before proceeding with clinical samples,

perform a background test. Refer to Section 6.3.1 Background Test. Prime can also be

performed manually from Test interface lower function buttons, select Prime.

Shutdown

To prevent measurement errors caused by sample residues, it is necessary to clean the

counting chambers and to rinse the liquid system. Shutting down the analyzer also

reboots the system. It is recommended to perform Shutdown as a minimum once a week.

When selecting Shutdown, the analyzer asks if soaking should be performed. It is

Section 9 Maintenance

recommended to perform Probe Cleaning with Soak, once a week or when 25 samples

have been processed. To proceed with soaking, select OK and aspirate H50V Probe

Cleaner through sample probe. For detailed instructions, refer to Section 6.11 Shutdown

and Logout.

Surface Maintenance

Clean the analyzer surface carefully with a soft cloth and DI water. Remove possible

traces of salt crystals and blood on the sample probe, to prevent protein deposition and

mildewing. Wipe the surrounding area of probe with a paper tissue moistened with a

70% alcohol solution.

Sample Probe Cleaning

Clean the sample probe with paper tissue moistened with a 70% alcohol solution. Wipe

dry and ensure no alcohol solution is left on the probe before analyzing next sample.

CAUTION

Never use corrosive acids, alkaline, or volatile organic solvents (such as acetone,

ether and chloroforms) to wipe the outside of the analyzer. Only use water and a

mild soap.

Section 9 Maintenance

9.1.2 Maintenance Setup

1. In the Setup interface, select Maint. Set. See Figure 9- 1.

Figure 9-1 Setup Interface

2. A popup dialogue called Maint. Set appears with several different settings.

The settings are explained below:

Auto blank:

Select On or Off. Select OK to save settings. If Auto blank is set to On, the analyzer

will automatically perform a background test after Startup of the analyzer.

Pre-dilute alarm:

Select On or Off. Select OK to save settings.

Soak and exit:

Select On or Off. Select OK to save settings. If On is selected, the analyzer will ask if

soaking should be performed before shutting down. Aspirate Probe cleaner via the

sample probe to clean the system. Shut down the analyzer after soaking.

Audible alarm:

Select On or Off. When set to On, the alarm sounds when an error code appears, and

when aspiration of sample probe is done.

Section 9 Maintenance

Auto prime:

If Auto prime is set to Off, no automatic prime cleaning is performed. Select the

desired number of analyzed samples before the analyzer automatically repeats the prime

cleaning. Select Off, 50, 75, 100, 125, or 150 cycles.

Auto sleep:

The analyzer automatically enters the dormant state after inactivity for a certain time if

a time interval has been chosen. Select Off, 20, 40, 60, 80, 100, or 120 min.

Auto soak:

If Auto soak is set to Off, no automatic probe cleaning is prompted. Select the desired

number of analyzed samples (25 is recommended) before the analyzer automatically

repeats the soaking. Select Off, 25, 50, 75, 100, or 125 cycles.

Sample Mixer

Selecting Sample Mixer On, the mixer starts to rotate. When you want to turn off the

mixer, select Sample Mixer Off. Refer to Section 6.5.3.

9.2 Intermittent maintenance

There are several maintenance functions that should be done when needed.

1. In the Setup interface, select Maintenance. See Figure 9- 1.

2. The Maintenance interface appears, see Figure 9-2.

Each function is described in detail below.

Figure 9-2 Maintenance Interface

Section 9 Maintenance

9.2.1 Prime Reagent

This function is a priming function, enabling new liquid in the tubing. Perform the

priming in the Prime Lyse/Diluent/Detergent, or S heath reagents i n the f ollowing

situations:

• Bubbles are present in reagent tubing.

• Reagent tubing is contaminated.

• Reagent has expired.

• Reagent has been replaced.

To perform the priming:

1. Select either Prime Lyse, Prime Diluent, Prime Detergent, or Prime Sheath.

2. The analyzer executes the operation. All buttons turn gray.

3. Priming is completed, and all buttons return to normal.

WARNING

Refer to local regulations and established laboratory protocol for handling

biohazardous materials. This should include use of gloves, lab coat and eye

protection.

NOTE

Do not shake the reagent. Let it stand to equilibrate before use to ensure it is stable.

Always perform a background test after replacing a reagent to ensure the

background values are within the acceptable range.

9.2.2 Cauterize Aperture

To prevent and eliminate blockage, the Aperture is cauterized with a high voltage to

clear protein and dust that adhere or block the aperture.

1. Select Cauterize Aperture in the Maintenance interface.

2. The analyzer executes the operation. All buttons turn gray.

3. When the operation is completed, buttons return to normal.

4. It is recommended to Flush Aperture.

9.2.3 Flush Aperture

The Aperture is flushed to clean it from debris. This prevents and eliminates clogging

together with the Cauterize Aperture function.

1. Select Flush Aperture in the Maintenance interface.

2. The analyzer executes the operation. All buttons turn gray.

3. When the operation is completed, buttons return to normal.

Section 9 Maintenance

9.2.4 Soak Impedance Transducer

The impedance transducer is soaked in Probe cleaner.

Select Soak impedance transducer in the Maintenance interface.

1. The analyzer executes the operation. All buttons turn gray.

2. Put probe cleaner under the sample probe when prompted by the analyzer.

3. When the operation is completed, buttons return to normal.

If the aperture is severely clogged, select Soak impedance transducer, and put Probe

cleaner under the sample probe. The analyzer will automatically aspirate Probe cleaner

into the transducer to soak the aperture.

CAUTION

Probe cleaner contains sodium hypochlorite and is corrosive. Immediately wipe up

any spill. Wear protective clothing and rubber gloves.

9.2.5 Prepare Shipping

Perform the Prepare Shipping operation when:

• the analyzer will be transported.

• the analyzer will not be used for a week or longer.

It is very important to perform the Prepare Shipping operation to avoid

crystallization, which can cause complicated and expensive repairs ofthe system.

1. In the Setup interface, select Maintenance.

2. Select Prepare Shipping.

3. Select OK in popup dialogue box.

4. Remove all reagent inlet tubes from the containers. The analyzer empties the liquid

system, the procedure will take a few minutes.

5. When the operation is complete, put all reagent inlets into a bottle of distilled water.

6. Repeat Steps 1-3. The analyzer fills the liquid system with distilled water.

7. When system is filled, repeat Steps 1-3, and remove the reagent tubes from the

water bottle.

8. The analyzer empties the liquid system.

9. When system is empty, turn off the analyzer.

10. Remove all tubes from the back of the analyzer.

11. Keep the tubes intact and well stored.

12. Keep the remaining reagents in their containers and store them as recommended

(refer to Section 1.5 Consumables Overview).

13. The analyzer is now ready for transport or storage.

Section 9 Maintenance

9.2.6 Other Maintenance Functions

There are four other maintenance functions.

Soak sheath flow regulator: Sheath flow regulator is soaked in Probe cleaner.

Empty transducer: liquid is emptied from the transducer.

Rinse impedance channel: impedance channel is cleaned.

Rinse optics channel: optics channel is cleaned.

9.3 Maintenance by Service technician

9.3.1 Components Maintenance

Maintenance on the following components by a service technician is required

annually.

• Reagent syringes

• Mechanical parts

• Syringe module

• Sample injection mechanism

• Sample cup/Transducer

• Sheath regulator

• Waste filters (should be visually inspected and replaced if needed).

9.3.2 Components Replacement

Replacement of the following components should be performed by service technician

every year:

• Probe wiper

• Syringe seals

• Waste filters (should be visually inspected and replaced if needed).

9.4 Disposal Information

Operators are advised to be knowledgeable of applicable local, state, and federal

requirements, and the content of effluent streams, before disposing of waste in public

sewer systems or recycling decontaminated equipment.

Disposal Material

• Used reagents

• Reagents mixed with potentially biohazardous material

• Instrument and instrument components

• Controls and calibration material

• Li-Ion battery

Section 9 Maintenance

Manufacturer Guidelines for Waste Products

• Place the instrument close to a waste container or drain suitable for disposal of

used reagents.

• Check that the drainage is suitable for disposal of chemical and biological waste.

• Check that the waste tube is securely fastened in the drain.

Always follow local guidelines for open drain.

Decontamination and Disposal

The European Directive 2012/19/EU on Waste Electric and Electronic Equipment

(WEEE) aims to minimize the impact on the environment by prevention of waste. The

H50V veterinary hematology analyzer has been labeled with the WEEE symbol, and

there is a procedure to allow waste collection and recycling of the equipment at the end

of its life cycle.

• The instructions for decontamination and disposal, including reagents, can be

found at boule.comunder Product documents.

• If there are any question on how to follow this procedure, contact your local

distributor for more information.

• The analyzer should be considered as infected, and the end user must follow a

decontamination procedure before it is safe to hand over to a recycler.

Section 10 Advanced Setup

10 Advanced Setup

10.1 Parameter

To change parameter units, do the following:

1. In the Setup interface, select Param.

2. Choose unit for the listed parameters (WBC, RBC, PLT, HGB/MCHC, IRF,

HCT and MCH).

3. Select OK to save the settings.

To modify the reaction time for lysing RRBC, do the following:

1. In the Setup interface, select Param.

2. In RRBC reaction time, adjust the lysing time.

3. Select Default to revert to factory settings.

4. Select OK to save the settings.

10.2 Display

The Display function is used to customize which parameters are shown in the Parameter

display area. For details on analysis parameters, see Section 3.3.

1. In the Setup interface, select Display.

2. Choose which parameters to be displayed.

3. Select OK to save the settings.

10.3 Transmit

The Transmit interface is used to set up the communication between the H50V analyzer

and a computer with LIS.

1. In the Setup interface, select Transmit.

2. In Ethernet port setup, enter the IP address of the instrument as Local IP. Enter

the IP address of the computer as Server IP. Enter the port number of the

computer for the LIS to receive data. Local mask and local gateway can typically

be left with default values.

3. In Transmission setting, set Auto Trans to On or Off to control automatic data

transmission.

4. Select Save to save settings.

The Serial Port setting is used for connection between the instrument and computer

with serial cable instead of ethernet.

Section 10 Advanced Setup

10.4 Version

To view current version information, do the following:

1. In the Setup interface, select Version.

2. Select Return to go back to Set up interface.

10.5 Service

To enter the Service interface, do the following:

1. In the Setup interface, select Service.

2. Under Password enter appropriate command and select OK.

Only Boule authorized service engineers can enter the Service interface for

maintenance.

10.6 System log

This function is used to export instrument data useful for Service.

1. In the Setup interface, select System log.

2. Choose which file or files to export. Use the arrows to navigate the list.

3. Insert a USB memory stick into the analyzer.

4. Select Export. The chosen files will be downloaded to the USB memory stick.

Section 11 Troubleshooting

11 Troubleshooting

This section gives instructions for identifying system problems and how to solve them.

If the malfunction cannot be solved according to the instructions, or if more detailed

information is needed, contact your local distributor or authorized service technician.

WARNING

Refer to local regulations and established laboratory protocol for handling

biohazardous materials. This should include use of gloves, lab coat and eye

protection.

11.1 Troubleshooting Guidance

Troubleshooting guidance is used to assist the operator in identifying and resolving

analyzer problems. The first step in the process i s to understand normal an alyzer

operation, and the importance of performing routine maintenance. Good knowledge of

the analyzer is essential for identifying and resolving operational problems.

Follow these three steps to troubleshoot:

1) Problem Confirmation

Confirm what the problem is and compare it to how it should be in normal

circumstances. It is important to accurately identify the problem, to identify the proper

solution.

2) Problem Classification

Problems are divided into three types.

• Hardware-related failures

• Software-related failures

• Failures of sample measurements

3) Troubleshooting

Address sample measurement problems using this guide. If no corrective action can be

done, or if the problem is not corrected, contact your local distributor or authorized

service technician.

11.2 Troubleshooting

Common error codes, probable causes, and corrective actions are listed below. If the

problems cannot be corrected, or if technical assistance is needed, contact your local

distributor or authorized service technician.

Section 11 Troubleshooting

Some motor functions in analyzer are equipped with transport locking, make sure that

these locks have been removed before operating the analyzer.

During troubleshooting, the operator might be recommended to select Fault clearing.

The function Fault clearing means that the analyzer will automatically take action to

resolve the issue. The actions taken depend on the problem. For example, if a WBC or

RBC Clog is the cause the analyzer will perform a series of cleaning cycles. Once

corrected, the error code will disappear.

Error code

Probable Cause

Corrective Action

•

MA motor fault

•

MB motor fault

•

MC motor fault

•

MD motor fault

•

MG motor fault

•

MH motor fault

1. Poor contact on motor

signal line.

2. Optocoupler limit.

3. Motor fault.

4. Motor drive circuit

fault.

5. Motor power fault.

6. Motor guide rod is

not lubricated enough.

1. Check that all transport locks

have been removed.

2. Select Fault clearing to clear

faults automatically.

3. If the problem persists,

contact

your local distributor or

authorized service technician.

•

Expired Diluent

•

Expired Sheath

•

Expired Lyse

•

Expired Detergent

Reagent has expired.

1. Change reagent (refer to

Section 4.8).

2. Select Fault clearing to clear

faults automatically.

3. If the problem persists,

contact

your local distributor or

authorized service technician.

•

Diluent Empty

•

Sheath Empty

•

Lyse Empty

•

Detergent Empty

1. Reagent is empty.

2. Tube joint leakage or

bubble.

3. Connecting tubes are

bent or clogged.

1. Check if the reagent has run

out.

2. If finished, change reagent

(refer to Section 4.8).

2. Tighten the tube joint.

3. Neaten and unchoke tubes.

4. Select Fault clearing to clear

faults automatically.

5. If the problem persists,

contact

your local distributor or

authorized service technician.

Section 11 Troubleshooting

Error code

Probable Cause

Corrective Action

•

WBC Clog

•

RBC Clog

1. Aperture is clogged.

2. Tubes are bent.

3. Reagent replacement

error.

4. Solenoid valve

problem.

1. Select Fault clearing to clear

faults automatically.

2. Clean impedance chamber

with H50V Probe cleaner. In

Maintenance interface, select

Setting and perform Soak

impedance transducer. Once

prompted, aspirate H50V Probe

Cleaner through sample probe.

3. If the problem persists,

contact

your local distributor or

authorized service technician.

•

WBC Bubble

•

RBC Bubble

1. Insufficient liquid in

sample cup front

chamber/ after chamber.

2. Tube joint is leaking.

3. Reagent replacement

error.

4. Solenoid valve

problem.

1. Select Fault clearing to clear

faults automatically.

2. If the problem persists,

contact

your local distributor or

authorized service technician.

HGB Blank voltage

low

HGB blank voltage is

low.

1. Select Fault clearing to clear

faults automatically.

2. If the problem persists,

contact

your local distributor or

authorized service technician.

HGB Blank voltage

high

HGB blank voltage is

high.

1. Select Fault clearing to clear

faults automatically.

2. If the problem persists,

contact

your local distributor or

authorized service technician.

Low vacuum

1. Vacuum tank is

leaking.

2. Tubes are leaking.

1. Select Fault clearing to clear

faults automatically.

2. If the problem persists,

contact

your local distributor or

authorized service technician.

Optical pressure

Abnormity

1. Pressure tank is

leaking.

2. Tubes are leaking.

1. Select Fault clearing to clear

faults automatically.

2. If the problem persists,

contact

your local distributor or

authorized service technician.

Section 11 Troubleshooting

Error code

Probable Cause

Corrective Action

Low temperature

Temperature is below

15°C.

1. Check if indoor temperature is

too low.

2. If indoor temperature is

normal, but alarm still rings,

restart the analyzer.

3. If the problem persists,

contact

your local distributor or

authorized service technician.

High temperature

Temperature is over

35°C.

1. Check if indoor temperature is

too high.

2. If indoor temperature is

normal, but alarm still rings,

restart the analyzer.

3. If the problem persists,

contact

your local distributor or

authorized service technician.

Waste full

1. Waste container is

full.

2. Waste sensor is

faulty.

1. Empty waste container or

replace it.

2. If the problem persists,

contact

your local distributor or

authorized service technician.

Optical

communication

error

Optical communication

is abnormal. Cannot

receive and send data.

1. Select Fault clearing to clear

faults automatically.

2. If the problem persists,

contact

your local distributor or

authorized service technician.

Printer is not

responding

1. Connecting line not

working.

2. Printer error.

1. Check the if the printer power

cord and USB cable contacts

well. Re-plug USB cable and

power cord and restart the

printer.

2. If the problem persists,

contact

your local distributor or

authorized service technician.

11.3 Obtaining Technical Assistance

Contact your local distributor for orders and support. Have the product number ready

for orders. For technical or other assistance, contact your local Boule service

representative. Be prepared to provide the following information:

Section 11 Troubleshooting

• Analyzer model.

• Serial number and version number.

• Description of the problem and surroundings, including status and operation.

• Lot numbers of reagents (Sheath, Diluent, Lyse, etc.).

• Related data and report of the problem.

• Pictures and videos may be asked for by the Boule service representative.

11.4 Abnormal Results

Alarm information Interpretation Measures

Abnormal WBC scatter

diagram

WBC scatter diagram is

abnormal.

Check the data and repeat the

analysis or examine in

accordance with the protocol

of your laboratory.

Neutropenia

Neu# < 1.00×10

9

/L

Low Neu count

Check the data and repeat the

analysis or examine in

accordance with the protocol

of your laboratory.

Neutrophilia

Neu# > 11.00×10

9

/L

High Neu count

Check the data and repeat the

analysis or examine in

accordance with the protocol

of your laboratory.

Lymphopenia

Lym# < 0.80×10

9

/L

Low Lym count

Check the data and repeat the

analysis or examine in

accordance with the protocol

of your laboratory.

Lymphocytosis

Lym# > 4.00×10

9

/L

High Lym count

Check the data and repeat the

analysis or examine in

accordance with the protocol

of your laboratory.

Monocytosis

Mon# > 1.50×10

9

/L

High Mon count

Check the data and repeat the

analysis or examine in

accordance with the protocol

of your laboratory.

Eosinophilia

Eos# > 0.70×10

9

/L

High Eos

Check the data and repeat the

analysis or examine in

accordance with the protocol

of your laboratory.

Basophilia

Baso# > 0.20×10

9

/L

High Bas

Check the data and repeat the

analysis or examine in

accordance with the protocol

of your laboratory.

Section 11 Troubleshooting

Alarm information

Interpretation

Measures

Leukopenia

WBC < 2.50×10

9

/L

Low WBC count

Check the data and repeat the

analysis or examine in

accordance with the protocol

of your laboratory.

Leukocytosis

WBC > 18.00×10

9

/L

High WBC count

Check the data and repeat the

analysis or examine in

accordance with the protocol

of your laboratory.

NRBC increase

NRBC：Nucleated red

blood cells.

The following conditions

may cause NRBC alarm:

•

WIC count>WOC

count

NRBC suspected to exist.

Re-analyze the samples in

CBC+5DIFF+RRBC mode.

Review the smear for

abnormal cell morphology

(abnormal RBC and

NRBCs). If NRBCs are

present, they should be

quantified and excluded from

WBC count in accordance

with your laboratory’s

policy.

Immature erythrocyte

Immature erythrocytes

might exist.

Examine the peripheral

smear for the presence of

abnormal RBC morphology.

Report any clinically

significant finding according

to individual laboratory

guidelines.

RRBC appears

RRBC：Refractory red

blood cells.

The following conditions

may cause RRBC alarm:

•

WOC count >WIC

count

RRBC suspected to exist.

Re-analyze the samples in

CBC+5DIFF+RRBC mode.

Review the smear for

abnormal cell morphology

(abnormal RBC and

NRBCs). If NRBCs are

present, they should be

quantified and excluded from

WBC count in accordance

with your laboratory’s

policy.

Section 11 Troubleshooting

Alarm information

Interpretation

Measures

Abnormal WBC results WBC sign indicates

WBC result is abnormal.

1.WBC exceeds linearity

range.

2. There is a clinical

difference between WIC

value and WOC value,

and accurate WBC value

cannot be determined by

algorithm.

1. Dilute the sample (eg

1:10) with Diluent. Re-

analyze the samples in

CBC+5DIFF. Multiply

WBC, RBC and HCT by the

dilution factor and determine

MCV and MCH directly

from the dilution. PLT is

determined from the

undiluted sample.

2. Perform a manual WBC

differential according to your

laboratory’s policy.

Abnormal WBC

differential count

DFLT：Leukocyte

categories abnormal

(NLMEB：N ＝NEU, L

=LYM, M ＝MON,

E=EOS, B ＝BASO).

The following conditions

may cause a DFLT

alarm:

1. The two cell

populations areas

overlap.

2. The number of cells in

a specific subgroup is

abnormally low. Such as

WBC increase &

decrease, neutrophil

increase & decrease,

lymphocytes increase &

decrease, eosinophils

increase & decrease,

basophils increase &

decrease.

Perform a manual WBC

differential

according to your

laboratory’s policy.

Parasitic infected RBC?

RBC might be infected

with parasites.

Examine the peripheral

smear to evaluate RBC

morphology. Report any

clinically significant finding

according to individual

laboratory guidelines.

Section 11 Troubleshooting

Alarm information

Interpretation

Measures

Abnormal LYM?

There might be abnormal

LYM.

Perform a manual WBC

differential

according to your

laboratory’s policy.

Left shift? Histogram shifts left.

Perform a manual WBC

differential

according to your

laboratory’s policy.

Atypical LYM?

There might be atypical

LYM.

Perform a manual WBC

differential

according to your

laboratory’s policy.

Abnormal RBC size

distribution

Height of histogram at

parting line is over 20.

Histogram between

parting lines distributes

double peaks.

Examine the peripheral

smear for the presence of

abnormal RBC morphology.

Report any clinically

significant finding according

to individual laboratory

guidelines.

Bimodal RBC

distribution

Histogram between

parting lines distributes

double peaks.

Examine the peripheral

smear for the presence of

abnormal RBC morphology.

Report any clinically

significant finding according

to individual laboratory

guidelines.

Abnormal RET

distribution

Scatter histogram

distribution is abnormal.

Perform the reticulocyte

count by an alternative

method.

RETIC increase RET% > 5%

or RET# > 0.2×10

12

/L

High RET count

Perform the reticulocyte

count by an alternative

method.

Anisocytosis RDW-SD > 65fL or

RDW-CV > 20%

Anisocytosis

No actions.

Microcytic RBC

MCV < 70fL

Small RBC

No actions.

Macrocytic RBC

MCV > 110fL

Large MCV

No actions.

Hypochromic

MCHC < 296g/L

Low pigment

No actions.

Section 11 Troubleshooting

Alarm information

Interpretation

Measures

Anemia

HGB < 100g/L

Anemia

No actions.

Polycythemia

RBC > 6.5×10

12

/L

RBC increase

No actions.

RBC aggregation?

RBC < 3.5×10

12

/L and

MCH > 34 pg

Might be due to

Macrocytic RBC or

Abnormal RBC size

distribution

Examine the peripheral

smear for the presence of

abnormal RBC morphology.

Report any clinically

significant finding according

to individual laboratory

guidelines.

Chylemia affects HGB? MCHC > 400g/L Examine the plasma for

lipemia, hemolysis or icterus.

If sample is lipemic or

icteric, perform a plasma

replacement, or a dilution to

obtain accurate HGB.

Iron deficiency? MCV < 73fL and

MCH < 21pg and

MCHC < 320g/L

Maybe hypoferric

anemia

No actions.

Abnormal HGB? MCV < 75fL and

MCH < 25pg and

RDW-SD < 45fL

Maybe HGB anomaly or

interference factors exist.

No actions.

Fragmented RBC?

Abnormal output sign of

PLT size distribution,

and microcyte alarm.

Doubt erythroclasis.

Examine the peripheral

smear for the presence of

abnormal RBC morphology.

Report any clinically

significant finding according

to individual laboratory

guidelines.

Light β- thalassemia？

Judge by original signal

and test results.

Maybe anemia

Examine the peripheral

smear for the presence of

abnormal RBC morphology.

Report any clinically

significant finding according

to individual laboratory

guidelines.

Section 11 Troubleshooting

Alarm information

Interpretation

Measures

Sideroblastic anemia？

Judge by original signal

and test results.

Maybe anemia

Examine the peripheral

smear for the presence of

abnormal RBC morphology.

Report any clinically

significant finding according

to individual laboratory

guidelines.

Megaloblastic anemia?

Judge by original signal

and test results.

Maybe anemia

Examine the peripheral

smear for the presence of

abnormal RBC morphology.

Report any clinically

significant finding according

to individual laboratory

guidelines.

Abnormal PLT size

distribution

Abnormal PLT size

distribution

Examine the peripheral

smear for the presence of

abnormal PLT morphology.

Perform a manual platelet

estimate to ensure the count

is accurate.

Thrombocytopenia

PLT < 60×10

9

/L

Thrombocytopenia

Examine the peripheral

smear for the presence of

PLT aggregation. Perform a

manual platelet estimate to

ensure the count is accurate.

Thrombocytosis

PLT > 600×10

9

/L

Thrombocytosis

Examine the peripheral

smear for the presence of

abnormal PLT morphology.

Perform a manual platelet

estimate to ensure the count

is accurate.

PLT aggregation?

Results might be affected

by aggregated PLT.

Examine the peripheral

smear for the presence of

PLT aggregation.

NOTE

If there is a request to adjust the limits related to an alarm, contact your local Boule

representative.

Appendix

12 Appendix

12.1 Appendix A: Components and Consumables

This appendix provides additional information about Boule components and

consumables. For ordering information, contact your local Boule representative.

Analyzer system

Article name

Article number

H50V Veterinary Hematology System

1440101

Documentation

Article name

Article number

User Manual

1504672

Quick Reference Guide

1504673

Decl. of Conformity H50V

1504647

Installation checklist H50V

1504532

Transport protection removal instruction 1440203

Consumables

Article name

Article number

H50V Diluent 10 L, RFID

1440102

H50V Diluent 5 L, RFID

1440103

H50V Diluent 1.9 L, RFID

1440104

H50V Detergent 5 L, RFID

1440105

H50V Detergent 1.9 L, RFID

1440106

H50V Sheath 5 L, RFID

1440107

H50V Sheath 1.9 L, RFID

1440108

H50V Lyse 500 mL, RFID

1440109

H50V Lyse 200 mL, RFID

1440110

H50V Probe Cleaner, 100 ml

1440111

H50V Reticulocyte stain, 50 x 4 ml

1440112

For further information on which consumables you require for your analyzer, contact

your local Boule representative.

Appendix

Produced by Boule Medical AB

DOMNARVSGATAN 4, 163 53 Spanga, Sweden

FCC ID: 2BPEL1440101

Boule H50V Veterinary Hematology System

Product's Documents

User Manual

Specifications

Boule H50V Questions and Answers

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