T-SEAL
®
Mobile
Portable Battery Sealer
Instructions for Use
Part No. LCT-7010en
2021-04
©Conroy Medical AB
©2021 Terumo BCT, Inc.
T-SEAL is a registered trademark of Terumo BCT, Inc.
Terumo BCT is either a registered trademark or a trademark of Terumo Corporation.
Conroy Medical AB:
Valhallavaegen 1
SE-194 63 Upplands
Vaesby SWEDEN
Distributed by:
Terumo BCT Europe
N.V.
Ikaroslaan 41
1930 Zaventem
Belgium
TERUMOBCT.COM
Every effort has been made to ensure that the information in this document is correct, but we make no
guarantee to this effect and would appreciate any observations regarding the contents of this
document. We may make improvements and alterations to the instrument and these changes will be
incorporated in new issues of this publication when practicable.
Print: Uffe Tryckare, Upplands Väsby, 2021
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Introduction
Contents
1 Introduction ........................................................................................................................................................ 2
2 Symbols/Markings Description ....................................................................................................................... 3
3 Warnings and Cautions ..................................................................................................................................... 5
3.1 Warnings ..................................................................................................................................................... 5
3.2 Caution ........................................................................................................................................................ 6
4 Specifications, Parts and Accessories .............................................................................................................. 7
4.1 Specifications .............................................................................................................................................. 7
4.2 Parts ............................................................................................................................................................. 9
4.3 Accessories................................................................................................................................................ 10
4.4 User-Interchangeable Parts .................................................................................................................... 10
5 Installation. ........................................................................................................................................................ 11
5.1 Unpacking and Inspection ..................................................................................................................... 11
5.2 Environmental Requirements ................................................................................................................ 11
5.3 Installation Procedure ............................................................................................................................. 11
6 Functional Description ................................................................................................................................... 13
6.1 Description of Sealing ............................................................................................................................. 14
6.2 Description of Equipment ..................................................................................................................... 15
6.3 Checking the Battery Unit ...................................................................................................................... 16
6.4 Recharging the Battery ............................................................................................................................ 16
7 Operating Instructions .................................................................................................................................... 17
7.1 Preparation Before Use .......................................................................................................................... 17
7.2 How to Seal Tubes .................................................................................................................................. 17
7.3 If the Sealer Does Not Start ................................................................................................................... 19
7.4 LED Indicators ........................................................................................................................................ 19
8 Troubleshooting ............................................................................................................................................... 20
8.1 Troubleshooting the Battery Unit ......................................................................................................... 20
8.2 Troubleshooting the Hand Unit............................................................................................................ 21
9 Cleaning ............................................................................................................................................................. 24
9.1 Battery Unit .............................................................................................................................................. 24
9.2 Hand Unit ................................................................................................................................................. 25
10 Warranty and Service ....................................................................................................................................... 26
10.1 Warranty .................................................................................................................................................... 26
10.2 Service ........................................................................................................................................................ 26
10.3 Product Disposal ..................................................................................................................................... 27
10.4 Technical support .................................................................................................................................... 27
11 EMC Tables ...................................................................................................................................................... 28
12 Declaration of Conformity ............................................................................................................................. 32
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Introduction
1 Introduction
This document contains a description of and specifications for T-SEAL
®
Mobile, a portable battery sealer
distributed by Terumo Blood and Cell Technologies (Terumo BCT).
T-SEAL Mobile is an automatic system for sealing polyvinyl chloride (PVC) or ethylene vinyl acetate
(EVA) tubes, especially for tubes in blood pack systems. T-SEAL Mobile creates a distinct sealing
pattern, resulting in segments that can be easily pulled apart (PVC) or separated with clean scissors
(EVA) with no damage to the blood inside the tubes. Tubing segments may be formed by inserting the
tubing into the slot at the front of the hand unit to create a series of seals.
T-SEAL Mobile comprises a hand unit and a battery unit that is connected to the hand unit with the
integrated cable. The hand unit includes a built-in sealing head and is ready to operate. The moving
electrode front can be easily removed for cleaning. Different types and sizes of tubes can be used, and the
sealing time differs according to tube types and sizes.
T-SEAL Mobile uses radio-frequency (RF) energy to generate heat for sealing. Users should be cautious
of potential electrical shocks or hazards while handling this sealer.
Symbols/Markings Description
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2 Symbols/Markings Description
The following symbols may appear on the instrument or on labels:
This marking reflects compliance with the Council Directive 2017/745 on Medical
Devices.
Symbol for “MEDICAL DEVICE.”
This marking reflects compliance with national standards for the United States
(ANSI/AAMI ES60601-1:2005) and Canada (CSA C22.2 No. 60601-1).
Symbol for class II battery charger: double insulation during charging.
Symbol indicating that the battery charger is a UL-recognized component for
Canada and the U.S.
Symbol for “catalog number.”
Symbol for “warning.”
Symbol for “follow instructions.”
Symbol for “serial number.”
Symbol for “date of manufacture.”
Symbol for “manufacturer.”
Keep dry.
Fragile, handle with care.
Storage conditions — symbol for “temperature.”
Symbols/Markings Description
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Storage conditions — symbol for “relative humidity.”
Symbol for “non-ionizing radiation.”
Symbol (WEEE 2002/96/EC) — Do not dispose of Product as municipal waste.
Collect Product separately. Use collection and return systems available to you. Product
brought to EU market after 13 August 2005.
Symbol to indicate information about the battery.
Symbol for direct current (DC).
Warnings and Cautions
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3
Warnings and Cautions
The general safety information in these instructions for use (IFU) is intended for operating personnel.
Specific notes, cautions, and warnings are found throughout this IFU where applicable. Please read
this IFU carefully before using T-SEAL Mobile.
Note: Identifies conditions that should be noted carefully.
Caution: Identifies conditions that could result in damage to the equipment.
Warning: Identifies conditions that could result in personal injury or loss of life.
3.1
Warnings
1.
T-SEAL Mobile must be used in compliance with all specifications and operational procedures
listed in this manual.
2.
Only trained personnel should use T-SEAL Mobile.
3.
Cables and accessories other than those specified may result in increased emissions or decreased
immunity of the equipment or system. Use only accessories that are designed for use with T-
SEAL Mobile.
4.
T-SEAL Mobile should not be used adjacent to or stacked with other equipment. If adjacent or
stacked use is necessary, T-SEAL Mobile should be observed to verify normal operation in the
configuration in which it will be used.
5.
If any of the components of T-SEAL Mobile are exposed to blood, they must be cleaned with
an appropriate disinfectant solution and according to your facility’s standard operating
procedures (SOPs).
6.
The T-SEAL Mobile hand unit generates RF energy during the sealing procedure and during
movement of the electrode.
7.
T-SEAL Mobile is not intended for use in an oxygen-rich environment.
8.
T-SEAL Mobile is not intended to be used with flammable anesthetics and is not intended for
use in conjunction with flammable agents.
9.
When sealing EVA tubing, use clean scissors to separate the tubing at the center of the seal.
Warnings and Cautions
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3.2
Caution
1.
ELECTROMAGNETIC INTERFERENCE REGULATIONS
This equipment fulfills EN 60601-1-2:2015 Standards for Electromagnetic Compatibility.
Nevertheless, this equipment uses radio-frequency (RF) energy to generate heat while the tube is
being sealed and can affect other medical electrical equipment. See Table 1 for guidance. If
installation and use is not performed in accordance with this IFU, T-SEAL Mobile may cause
interference with radio, television and instrument communications.
Specifications, Parts and Accessories
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4
Specifications, Parts and Accessories
4.1
Specifications
Specification Type
Value
Terumo BCT catalog number
T5460
Description
T-SEAL Mobile, a complete sealing system, which includes a battery
unit, a hand unit, a battery charger, an adaptor kit, and an IFU.
Type of PVC/EVA tube
T-SEAL Mobile senses the type and size of each tube and adjusts
the sealing time accordingly.
T-SEAL Mobile can seal tubes that meet the following
specifications:
- PVC tubes up to 6.2 mm (0.24 in) in outer diameter with
4.4 mm (0.17 in) inner diameter or 0.9 mm (0.04 in) wall
thickness
- EVA tubes up to 4.15 mm (0.16 in) outer diameter with
3.9 mm (0.15 in) inner diameter or 0.9 mm (0.04 in) wall
thickness
Sealing capacity
Approximately 1,500 seals per charge with PVC tubes up to 5 mm (0.2
in) outer diameter at 20 °C (68 °F).
Approximately 400 seals per charge with EVA tubes up to
4.15 mm (0.16 in) outer diameter at 20 °C (68 °F).
Continuous seal capacity
50
Mode of operation
Operation: 25%, Intermittent: 75%
Sealing time
Average between 0.4 seconds and 3 seconds, but can go up to 10
seconds, depending on the type and size of tubing that is being
sealed.
Intended use
T-SEAL Mobile is an automatic system for sealing PVC and EVA tubes
that are connected to blood bags included either in blood packs or in
apheresis disposable sets. The sealing can be performed when the
donor is still connected to the blood pack or the apheresis disposable
set.
Input power
Charger 100 V AC to 240 V AC/50 to 60 Hz
Battery 28.8 V DC, 2.4 Ah, lithium-ion manganese (LiIonMn)
Consumption
Charger: 30 W, sealer: 150 W max
Fuses
Charger: T2 A 250 V (internal)
Battery: 2 A (input)/10 A (output) (internal)
Specifications, Parts and Accessories
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Specification Type
Value
RF output
80 W max/50 Ω/40.680 MHz
Size (W × H × D) of battery
unit
165 mm × 106 mm × 32 mm (6.5 in × 4.2 in × 1.2 in)
Weight in kg (Ib)
Battery unit: 0.68 kg (1.50 lb)
Hand unit: 0.39 kg (0.86 lb)
Temperature
Operating: 15 °C to 35 °C (60 °F to 95 °F)
Storage: −20 °C to 70 °C (−4 °F to 158 °F)
Humidity
Operating: 10% to 90% Rh (non-condensing)
Storage: 10% to 90% Rh (non-condensing)
Altitude
Operating: Maximum 3,000 meters (9,842 feet)
In compliance with
EN 60601-1: 2006
General Requirements for basic safety and essential performance EN
60601-1-2: 2015
Collateral standards for Electromagnetic Compatibility
Electrical safety
During charging: Class II
During use: Internal power supply
T-SEAL Mobile is used in the same environment as medical equipment
(hospitals and blood banks).
It must be used by highly qualified personnel.
Manufacturer according to the
Medical Device Regulation
(MDR)
Conroy Medical AB:
Valhallavaegen 1
S-194 63 Upplands Vaesby
SWEDEN
Distributor
Terumo BCT Europe N. V.
Ikaroslaan 41
1930 Zaventem
Belgium
Specifications, Parts and Accessories
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4.2
Parts
T-SEAL Mobile comprises the parts listed below.
Description
Hand unit
Battery unit
Battery charger
and primary
adaptors kit
version 2
Primary adaptors
kit version 2
Spare front
electrode
Part Number
546900001
547900001
54410200
64614010
8METSM013
The following tables contain a list of all cables with their maximum lengths, transducers, and other
electrical accessories with which the manufacturer claims compliance (cables and accessories used other
than those listed may impact emission/immunity).
Part
Catalog Number
Specification
Battery charger and
primary adaptors kit
version 2
8METSM003
Input: 100 V AC to
240 V AC/50 to 60 Hz/800 mA
Output: 18 V DC/1.55 A
Primary adaptors kit
version 2
8METSM040
European mains connector
UK mains connector
Australia/New Zealand mains connector
U.S./Canada/Japan mains connector
Specifications, Parts and Accessories
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4.3
Accessories
The following table lists accessories that are available from Terumo BCT for T-SEAL
Mobile.
Description
Holster
Extension cord
1.2 m 5-pol
Catalog
Number
8METSM004
8METSM005
4.4
User-Interchangeable Parts
The following table lists user-interchangeable parts for T-SEAL Mobile and their respective
Terumo BCT catalog numbers.
Description
Hand unit
Battery unit
Battery charger
and primary
adaptors kit v2
Primary adaptors
kit version 2
Front electrode
Catalog
Number
8METSM001
8METSM002
8METSM003
8METSM040
8METSM013
Installation
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5
Installation
This chapter provides information about unpacking the system, required operating conditions, and
installation of the system.
5.1
Unpacking and Inspection
1.
Visually inspect the cardboard box for damage. If the packaging is damaged,
immediately contact your local Terumo BCT representative.
2.
Lift the system out of the cardboard box and place it on a flat surface. The
instrument is shipped in one cardboard box that includes:
I.
One hand unit
II.
One battery unit
III.
One battery charger and primary adaptors kit version 2
IV.
One spare front electrode
V.
One IFU (English)
VI.
One IFU (other languages) on CD-ROM
The above list is subject to change; refer to the packing list for an accurate description of
contents. If any parts are missing or damaged, immediately contact your local Terumo BCT
representative.
3.
Please retain all shipping and packaging materials, as they may be required for later
transportation, at least during the warranty duration.
5.2
Environmental Requirements
Set up T-SEAL Mobile according to the following requirements:
• Place the instrument on a flat surface that is free from dust, solvents, and acidic vapor.
• Use the instrument in an area that is free from vibration and has a room temperature of 15 °C
to 35 °C (60 °F to 95 °F) and a relative humidity of 10% to 90%.
• Handle the components with care in a clean environment.
5.3
Installation Procedure
Prepare the sealer for use.
1.
Fit the correct mains connector to the battery charger.
The primary adaptor kit version 2 includes mains connectors for the European continent,
UK, U.S./Canada/Japan and Australia/New Zealand.
2.
Connect the grey connector on the charger to the combined hand unit/battery charger cable
connector on the battery unit.
3.
Plug the charger into the mains. The charger can be connected to mains voltages between
100 V AC and 240 V AC.
4.
It takes about 4 hours to charge the battery unit completely. When the charge level indicator on
the unit indicates 100% and the recharge indicator flashes, the battery is fully charged.
5.
Fully charge the battery before you use the device for the first time.
6.
Connect the grey connector on the end of the hand unit cable to the hand unit/battery charger
cable connector on the battery unit. The connector will snap into place when it is securely
connected.
7.
Perform a test seal on a tube that is either empty or filled with water to ensure proper
operation.
Installation
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Caution: Use only the T-SEAL Mobile battery charger to charge the battery unit.
Note: Ensure that the hand unit is connected to the battery unit before use.
Note: T-SEAL Mobile can be used after charging the battery unit for at least 3 hours and can
perform 500 to 1,000 seals on PVC tubing.
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6
Functional Description
This chapter describes the T-SEAL Mobile components, including connectors and indicators, and their
functions. The chapter also provides an overview of how T-SEAL Mobile works.
Figure 1: Front view of the battery unit
1. Charge level indicator
2. Recharge indicator
3. Battery test button
4. Hand unit/battery charger cable connector
Figure 2: Rear view of the battery unit
Figure 3: View of the hand unit
1. Seal indicator
2. Tube slot
3. Fixed electrode
4. Moving electrode
5. Spring lock
6. Trigger
7. Electrode removal grip
Operating Instructions
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Figure 4: View of the battery charger
1. Power indicator
1. European continent mains connector
2. Australia/New Zealand mains connector
3. U.S./Canada/Japan mains connector
4. UK mains connector
Figure 5: View of the adaptor kit
6.1
Description of Sealing
The tube to be sealed is placed in the slot of the hand unit, between the electrodes. When the user
presses the trigger on the hand unit, the tube is pressed together and the sealing procedure begins
automatically. The radio frequency (RF) generator starts, and the energy is transferred from the fixed
electrode to the tube, which melts to a sterile welding pattern.
During the whole sealing process, the seal indicator on the front of the hand unit is lit orange. When the
seal indicator turns off, the sealing process is complete and the trigger may be released. The intelligent
sense control in the hand unit detects, controls, and adjusts the necessary sealing activity to give the best
sealing quality for the type of tube that is being sealed.
See section 7.4 for a description of the different LED indicators on the hand unit in case of problems.
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6.2
Description of Equipment
T-SEAL Mobile consists of a battery unit and a hand unit. Below is a short description of each
component.
The hand unit consists of an RF generator with intelligent sense control, an ergonomic hand grip with
trigger, a moving electrode (which can be removed for cleaning), and a cable with a connector. The hand
unit does not draw power from the battery when the trigger is not pressed.
The battery unit consists of the environmentally friendly LiIonMn battery pack, the built-in LED
charge level indicator, and the combined charger/hand unit connector. When fully charged, the battery
unit contains enough power for approximately 1,500 seals.
Operating Instructions
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6.3
Checking the Battery Unit
To check the battery, press the battery test button (see Figure 6 below) and the battery charge level
indicator lights up. The battery charge level indicator shows the charge level of the battery in steps of
twenty percent, from 100% (fully charged) on the left to 0% (fully discharged) on the right. The battery
can be recharged at any time or at least when zero (red) remains. When the battery is fully discharged the
LED indicator on the hand unit will light up red and sealing will not be possible.
6.4
Recharging the Battery
Connect the battery charger to the battery unit and the charger to the mains. The recharge indicator
lights up.
When the recharge indicator starts flashing, the battery is fully charged, and the charge current is
automatically turned off. The charge can be interrupted at any time without damage to the battery unit,
but it is recommended that you fully recharge the battery each time it is charged. Fully charging the
battery takes less than five hours.
Figure 6: Front view of the battery unit with battery level indications
Caution: Always check the seals when the charge level of the battery is low (20% or less).
Section 7.2 shows what the sealing pattern should look like.
Caution: Use only the T-SEAL Mobile battery charger for charging the battery unit.
Note: To guarantee a long life for the rechargeable battery, charge the battery between 5
°C and 35 °C (40 °F and 95 °F).
Note: If the recharge indicator does not light up, check that the battery unit is properly
connected to the battery charger and that the battery charger is properly connected to the
mains.
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7 Operating Instructions
This chapter describes the use of the instrument.
Warning: T-SEAL Mobile uses radio frequency (RF) energy to generate heat for
sealing. Users should be cautious of potential electrical shocks or hazards while
handling this sealer. Always keep your fingers away from the electrodes in the slot.
Never place any object other than the tube between the electrodes.
Warning: The T-SEAL MOBILE system emits a low level of electromagnetic
(non-ionizing) radiation during sealing. It should not be used near high-frequency
sensitive electronic equipment.
See Table 1 for guidance.
Warning: If you are sealing while the donor is still connected, do not allow the
electrodes to come directly in contact with the donor to preclude an RF burn.
Warning: If you are sealing while the donor is still connected, do not perform a
seal within 8 cm (3 in) of the needle to preclude an RF burn at the venipuncture
site.
Caution: Inspect all parts of the instrument for defects before use. Check the sealing
pattern if the hand unit is dropped.
Caution: Always check the seals when the charge level of the battery is low (20% or
less).
7.1
Preparation Before Use
1.
Place the system on a flat surface near where you are working or in the holster.
2.
If desired, push the battery test button on the battery unit to ensure that the battery contains
a sufficient charge level for operation.
3.
Connect the hand unit cable to the combined hand unit/battery charger cable
connector on the battery unit.
Note: Do not connect sealers other than the T-SEAL Mobile hand unit to the T-SEAL
Mobile battery unit.
7.2
How to Seal Tubes
1.
Place the tube in the slot on the hand unit.
2.
Ensure that the tube is positioned between the electrodes in the slot.
3.
Squeeze the trigger to bring the two electrodes closer together until the seal indicator on the
top of the hand unit lights up orange. The trigger will “click” when it is fully engaged. Sealing
normally takes 0.4 seconds to 0.9 seconds. The RF generator will automatically turn off after 10
seconds.
4.
When the seal indicator goes out, the sealing process is complete. Release the trigger and
remove the tubing.
Operating Instructions
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5.
When you seal PVC tubing, the center of the seal is very thin and you can separate the two
sides of the seal by pulling on both sides of the tube. When sealing EVA tubing, use clean
scissors to separate the tubing at the center of the seal.
6.
Check the seal for leakage.
Caution: Multiple seals on the same tube must be at least 1 cm (0.4 in) apart. Making
multiple seals too close together may result in increased pressure in the tube that can cause
microscopic cracks and holes in the seals.
Caution: In case of sealer malfunction (intermittent failure to seal, poor seal quality,
the sealing time seems too long or too short) contact your local Terumo BCT
representative for assistance.
Caution: Periodically check seals for leakage. For an example of a good and a bad sealing
pattern, see below.
Good sealing pattern Bad sealing pattern
Note: To avoid leakage, do not pull the tube while sealing. Keep the trigger fully engaged
until the orange light goes out. If the trigger is released, the sealing process stops.
Note: The tube must be dry on the outside.
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7.3
If the Sealer Does Not Start
T-SEAL Mobile performs self-checks before each seal to verify that the seal can be performed safely
and effectively. The table below describes some common problems and suggests some recommended
actions.
Problem
Recommended Action
Leaky or wet tube
Dry the outside of the tube and try again.
Tiny arcs between the electrodes
Dry the electrodes and try again.
Wet or dirty electrodes
Clean and dry the electrodes and try again.
Low/no capacity in the battery
Check the charge level in the battery and
recharge the battery if necessary.
Overheating (seal indicator on the hand unit is
blinking red)
Wait for the hand unit to cool down and try
again.
Not creating seals
Check the charge level of the battery unit and
ensure that the hand unit is properly connected to
the battery unit.
If the sealer still doesn’t start, see Chapter 8 for further information.
7.4
LED Indicators
Battery unit:
The battery unit includes a row of LED lights across the front to indicate the status of the battery.
• The recharge indicator lights up when the battery unit is connected to power and flashes
when the battery is fully charged.
• When the battery test button is pressed, the charge level indicator lights up to indicate the
battery charge level. Refer to section 6.3 for more information.
Hand unit:
The seal indicator on the top of the hand unit lights up with different colors and patterns to indicate
the status of the hand unit.
• The indicator lights up continuously orange when RF energy is being applied to the fixed
electrode during sealing and turns off when sealing is completed.
• The indicator flashes red when the hand unit has overheated. The system will not perform
a seal until the hand unit cools down.
• The indicator lights red for one second in case of a short circuit. The system will not perform a
seal.
• The indicator lights up continuously red in case of a low charge level in the battery. The
system will not perform a seal.
Troubleshooting
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8 Troubleshooting
Maintenance performed by the user is limited to replacing the battery unit, the battery charger, and the
hand unit. The following information identifies common problems and offers suggested solutions.
8.1
Troubleshooting the Battery Unit
Problem
Possible Cause
Recommended Action
The charge level indicator does
not light up when the battery
test button is pressed.
The battery charge is low.
Charge the battery for 4 hours.
The system has a blown fuse.
Contact your local
Terumo BCT representative.
There is some other cause.
Contact your local
Terumo BCT representative.
The recharge indicator does not
light up while the battery is
charging.
The battery is fully discharged.
Charge the battery for 48
hours.
The system has a blown fuse.
Contact your local
Terumo BCT representative.
There is some other cause.
Contact your local
Terumo BCT representative.
The charge level indicator does
not light up after the battery
has been charged for 48 hours.
The battery unit is defective.
Replace the battery unit, or
contact your local
Terumo BCT representative.
Troubleshooting
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8.2
Troubleshooting the Hand Unit
Problem
Possible Cause
Recommended Action
Sealing does not start when
you squeeze the trigger.
The electrodes in the hand
unit are wet.
Dry the electrodes; see
section 9.2.
The electrodes in the hand
unit are dirty.
Clean the electrodes; see
section 9.2.
The outside of the tube is wet.
Dry the outside of the tube and
the electrodes and try sealing
again.
There are tiny arcs between
the electrodes.
Dry the electrodes and try
sealing again.
The trigger does not fully engage
(does not “click”) when it is
squeezed.
Replace the hand unit, or
contact your local
Terumo BCT representative.
The hand unit is defective.
The battery does not contain a
sufficient charge for sealing.
Charge the battery for at least 3
hours.
The integrated cable on the
hand unit is damaged or
defective.
Contact your local
Terumo BCT representative.
There is some other cause.
Seals are of poor quality.
The charge level of the battery is
low.
Check the charge level of the
battery.
Charge the battery if needed.
The moving electrode does
not move smoothly.
Clean and oil the electrode
shaft; see section 9.2.
The electrodes in the hand
unit are wet.
Dry the electrodes and try
sealing again.
The electrodes in the hand
unit are dirty.
Clean the electrodes and try
sealing again; see section 9.2.
The moving electrode is out of
position.
See section 9.2, assembly of
electrode.
The hand unit is defective.
Replace the hand unit, or
contact your local
Terumo BCT representative.
Troubleshooting
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Problem
Possible cause
Recommended action
There is some other cause.
Contact your local
Terumo BCT representative
The tubing does not come
apart easily after sealing.
The moving electrode does
not move smoothly.
Clean and oil the electrode
shaft; see section 9.2.
The electrodes in the hand
unit are wet.
Dry the electrodes and try
sealing again.
The electrodes in the hand
unit are dirty.
Clean the electrodes; see
section 9.2.
The rim on the moving
electrode is damaged.
Contact your local
Terumo BCT representative.
There is some other cause.
Intermittent sealing.
The hand unit is defective.
Replace the hand unit, or
contact your local
Terumo BCT representative.
The integrated cable on the
hand unit is damaged or
defective.
Contact your local
Terumo BCT representative.
The battery unit is defective.
The seal indicator on the hand
unit stays lit after the trigger is
released.
The hand unit is defective.
Replace the hand unit, or
contact your local
Terumo BCT representative.
The seal indicator on the hand
unit does not light up.
The hand unit is defective.
Contact your local
Terumo BCT representative.
The seal indicator on the hand
unit flickers.
The integrated cable on the
hand unit is damaged or
defective.
Contact your local
Terumo BCT representative.
There is some other cause.
Troubleshooting
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Problem
Possible cause
Recommended action
The moving electrode cannot
be inserted after cleaning.
The trigger was squeezed
during cleaning, causing the
internal spring to come out of
position.
Complete the following steps
to reset the spring to its correct
position:
1.
Pull the blue trigger until
you hear a “click.”
2.
Carefully insert a pin with a
diameter of
3
mm (0.12 in) to
4
mm (0.16 in) and a
length of at least
100 mm (3.94 in) into the
opening on the front of the
hand unit where the
moving electrode is
normally placed.
3. Gently push the pin down to
reset the spring.
Be careful to avoid scratching
the surfaces with the pin. If you
are unable to reset the spring
following these instructions,
contact your local Terumo BCT
representative.
Warranty and Service
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9 Cleaning
This chapter gives information on the procedure and frequency for cleaning the battery unit and the
hand unit. T-SEAL Mobile requires minimal maintenance for efficient operation. Follow the cleaning
procedure below.
Warning: For your own safety, always disconnect the hand unit or battery charger
from the battery unit before cleaning T-SEAL Mobile.
Warning: Blood and blood products must be treated as potentially infectious at all
times. In the event of a blood spill, appropriate protective clothing should be worn
during cleanup procedures.
After residual biological material has been removed, surfaces that have been in contact with blood or
components must be disinfected using an appropriate disinfectant solution, such as isopropyl alcohol
70%. Alternatively, a freshly prepared sodium hypochlorite (household bleach) solution may be used to
disinfect surfaces. The sodium hypochlorite solution should be made by diluting 1 part household
bleach with 10 parts water.
Regardless of the disinfectant solution used, ensure that any residue is removed from surfaces of the
equipment to prevent corrosion or discoloration. Discard all materials that have been in contact with
blood or blood products according to your institution’s standard operating procedure (SOP) for disposal
of biohazardous materials.
Caution: Do not disinfect or sterilize any part of the sealer using an autoclave or ethylene
oxide gas. Doing so will render the sealer unusable and invalidate the warranty.
Caution: Do not use chemicals or abrasive cleaners such as acetone or ammonia to clean
T-SEAL Mobile. Do not use sharp-edged tools to clean T-SEAL Mobile, as these may
cause damage the finish of the units.
Caution: Do not allow any liquids into the electronic parts of the system.
9.1
Battery Unit
Clean the battery unit at least once per month. If any blood or blood product is spilled on the battery
unit, immediately remove the battery unit from use and clean it completely before returning it to use.
To clean the battery unit, wipe down the outside surfaces with a soft, lint-free cloth, virtually lint-free
cloth, or tissue that has been moistened with a mild detergent.
Caution: Do not submerge the battery unit in any kind of liquid under any
circumstances, as this will damage the battery and void the warranty.
Warranty and Service
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9.2
Hand Unit
Clean the handle and both electrodes at least once per month with a soft, lint-free cloth or virtually lint-
free cloth that has been moistened with a mild detergent. If any blood or blood product is spilled on
the hand unit, immediately remove the hand unit from use and clean it completely before returning it to
use.
Complete the following steps to clean the hand unit:
1.
Remove the moving electrode by performing the following actions:
a. Pull the blue trigger until you hear a “click” to release the moving electrode.
b. Push the spring lock forward.
c. First push the moving electrode inward, and then pull the electrode out.
2.
Wipe the handle and both electrodes with a soft, lint-free or virtually lint-free cloth that has
been moistened with a mild detergent. Carefully dry all surfaces. Ensure that the electrodes are
completely dry to prevent sparks.
3.
After cleaning, insert a cotton swab into the electrode shaft. Add a small drop of light machine
oil (spare part: 8METSM012) into the shaft. Twist and carefully move the swab up and down
before removing it.
4.
Inspect the electrodes for any mechanical damage or wear. Do not use parts that are damaged.
5.
Assemble the parts in reverse order.
6.
Ensure that the trigger and the spring lock are both in a fully forward position before you
insert the moving electrode.
7.
Insert the moving electrode, ensuring that it is positioned in parallel with the fixed electrode.
Squeeze the trigger twice and ensure that the moving electrode moves smoothly, is in
position, and is not loose.
Caution: The hand unit is not waterproof. Do not submerge the hand unit in any kind of
liquid under any circumstances. Doing so will generate tiny electric discharges, cause the
device to malfunction, and void the warranty.
Note: After cleaning the hand unit, you can perform some test seals on a tube to ensure
proper operation. Compare the pattern to the picture in section 7.2.
Note: Do not squeeze the trigger after removing the electrode, as this may block the
locking mechanism.
Note: If you are unable to insert the moving electrode after cleaning, the trigger may have
been engaged during cleaning, causing the spring to come out of position. See section 8.2
for instructions on resetting the spring.
Warranty and Service
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10 Warranty and Service
This chapter provides information on the warranty and the service provided by Terumo BCT.
10.1
Warranty
Terumo BCT guarantees that the equipment shall be free from defects in material and workmanship
when delivered to the original purchaser. Terumo BCT´s sole obligation shall be limited to repair or
replacement, at Terumo BCT´s option and expense, of the defective part or unit for a period of two (2)
years following the date of initial delivery to the original purchaser.
The warranty extends only to the original purchaser, is not assignable or transferable, and shall not
apply to auxiliary equipment or disposable accessories.
Terumo BCT guarantees that the equipment is fit for the purposes and indications described in the
labeling when used in accordance with the instructions for use. Unless the equipment is used in
accordance with such instructions, this warranty is void and of no effect. No other expressed or implied
warranty exists, including any warranty of merchantability or appropriateness for a particular purpose.
Terumo BCT’s sole obligation and original purchaser’s exclusive remedy for breach of warranty shall be
limited to repair or replacement at Terumo BCT´s option. Terumo BCT shall not be liable for proximate,
incidental or consequential damages. Modifications, alterations, recalibrations or abuse, and service by
other than a Terumo BCT authorized representative, will void the warranty.
10.2
Service
Service under warranty period
While under Terumo BCT warranty, the instrument must not be opened by unauthorized
personnel.
Contact your Terumo BCT representative for service and repair information for all T-SEAL Mobile
systems.
Preventive Inspection and Maintenance
At least every second year, T-SEAL Mobile should be fully inspected by the qualified service organization
of the original purchaser, or by Terumo BCT or Terumo BCT’s authorized representative.
Interchangeable Parts Replacement (Maintenance Performed by the User)
Maintenance is limited to replacing the hand unit, the battery unit or the battery charger. Chapter 8
provides troubleshooting information for common problems.
Warranty and Service
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10.3
Product Disposal
Please follow the guidelines listed below for disposal of T-SEAL Mobile or any of its components or
accessories at the end of the calculated life cycle of 7 years:
• Do not dispose of T-SEAL Mobile as unsorted municipal waste.
• Collect T-SEAL Mobile separately.
• Use the collection and return systems available to you.
For more information on return, recovery, or recycling of T-SEAL Mobile, please contact your
local Terumo BCT representative.
10.4
Technical support
Toll-free numbers in Europe:
A
0800-293711
B
0800-94410
DK
808-80701
SF
0800-115226
IRL
1800-553224
CH
0800-563694
F
0800-908793
I
800-785891
UK
0800-9179659
D
0800-1808183
NL
0800-0222810
N
0800-12270
GR
00800-3212721
E
900-963251
S
020-791373
From other countries, call +32.16.39.14.00 at international rates.
E-mail: meservice@terumobct.com
EMC Tables
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11 EMC Tables
Table 1: Guidance and Manufacturer’s Declaration — Electromagnetic Emission
The T5460 T-SEAL Mobile Portable Tube Sealer is intended for use in the electromagnetic environment
specified below. The customer or the user of the T5460 T-SEAL Mobile should assure that it is used in
such an environment.
Emission Test
Compliance
Electromagnetic Environment — Guidance
RF emission
CISPR 11
Group2
The T5460 T-SEAL Mobile must emit electromagnetic
energy in order to perform its intended function. Nearby
electronic equipment may be affected.
RF emission
CISPR 11
Class A
The T5460 T-SEAL Mobile is suitable for use in all
establishments other than domestic and those directly
connected to the public low-voltage power supply network
that supplies buildings used for domestic purposes.
Harmonic emission
IEC 61000-3-2
Not applicable
Voltage fluctuations/
Flicker emissions IEC
61000-3-3
Not applicable
EMC Tables
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Table 2: Guidance and Manufacturer’s Declaration — Electromagnetic Immunity
The T5460 T-SEAL Mobile is intended for use in the electromagnetic environment specified below. The
customer or the user of the T5460 T-SEAL Mobile should assure that it is used in such an environment.
Immunity Test
IEC 60601
Test Level
Compliance
Electromagnetic Environment —
Guidance
Electrostatic
discharge
(ESD)
IEC 61000-4-2
± 6kV contact
± 8kV air
6kV
8kV
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative humidity
should be at least 30%.
Electrical fast
transient/burst
IEC 61000-4-4
± 2kV for power
supply lines
± 1kV for
input/ output
lines
2kV
Not applicable
Mains power quality should be that of a
typical commercial or hospital
environment.
Surge
IEC 61000-4-5
± 1kV line(s)
to line(s)
± 2kV line(s)
to earth
1kV
2kV
Mains power quality should be that of a
typical commercial or hospital
environment.
Voltage dips,
< 5% UT
< 5% U
T
Mains power quality should be that of
short
(> 95% dip in UT)
(> 95% dip in U
T
)
a typical commercial or hospital
interruptions
for 0.5 cycle
for 0.5 cycle
environment.
and voltage
variations on
40% U
T
40% U
T
power supply
(60% dip in U
T
)
(60% dip in U
T
)
input lines
for 5 cycles
for 5 cycles
IEC 61000-4-11
70% U
T
70% U
T
(30% dip in U
T
)
(30% dip in U
T
)
for 25 cycles
for 25 cycles
< 5% U
T
< 5% U
T
(> 95% dip in U
T
)
(> 95% dip in U
T
)
for 5 sec
for 5 sec
Power
3 A/m
3 A/m
Power frequency magnetic fields
frequency
should be at levels characteristic of a
(50/60 Hz)
typical location in a typical commercial
magnetic field
or hospital environment.
IEC 61000-4-8
Note: U
T
is the AC mains voltage prior to application of the test level.
EMC Tables
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Table 3: Guidance and Manufacturer’s Declaration — Electromagnetic Immunity
The T5460 T-SEAL Mobile is intended for use in the electromagnetic environment specified be- low.
The customer or the user of the T5460 T-SEAL Mobile should assure that it is used in such an
environment.
Immunity
Test
IEC 60601 Test
Level
Compliance
Level
Electromagnetic Environment — Guidance
Portable and mobile RF communications
equipment should be used no closer to any
part of the T5460 T-SEAL Mobile including
cables than the recommended separation
distance calculated from the equation
applicable to the frequency of the transmitter.
Conducted RF
3 Vrms
3 V
Recommended separation distance
IEC 61000-4-6
150 kHz to
d = 1.17 √P
80 MHz
Radiated RF
3 V/m
IEC 61000-4-3
3 V/m
d = 1.17 √P 80 MHz to 800 MHz
80 MHz to
2.5 GHz
d = 2.33 √P 800 MHz to 2.5 GHz
Where P is the maximum output power rating
of the transmitter in watts (W) according to the
transmitter manufacturer and d is the
recommended separation distance in meters
(m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey,
a
should be less than the compliance level in
each frequency range.
b
Interference may occur in the vicinity of
equipment marked with the following symbol:
Note: At 80 MHz and 800 MHz, the higher frequency range applies.
Note: These guidelines may not apply in all situations. Electromagnetic propagation is affected
by absorption and reflection from structures, objects and people.
a.
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) tele- phones and
land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted
theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured field strength in the location in which the
T5460 T-SEAL MOBILE is used exceeds the applicable RF compliance level above, it should be observed to
verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as
reorienting or relocating the T5460
T-SEAL Mobile.
b.
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
EMC Tables
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Table 4: Recommended separation distance between portable and mobile RF
communications equipment and the T5460 T-SEAL Mobile
The T5460 T-SEAL Mobile is intended for use in the electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the T5460 T-SEAL Mobile can help prevent
electro-magnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the T5460 T-SEAL Mobile as recommended below,
according to the maximum output power of the communications equipment.
Rated
maximum
Output power
of transmitter
W
Separation distance according to frequency of transmitter
m
150 kHz to 80 MHz
d = 1.17 √P
80 MHz to 800 MHz
d = 1.17 √P
800 MHz to 2.5 GHz
d = 2.33 √P
0.01
0.12
0.12
0.23
0.1
0.37
0.37
0.74
1
1.2
1.2
2.3
10
3.7
3.7
7.4
100
11.7
11.7
23.3
For transmitters rated at a maximum output power not listed above, the recommended separation distance d
in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is
the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
Note: At 80 MHz and 800 MHz, the higher frequency range applies.
Note: These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
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Declaration of Conformity
12 Declaration of Conformity
