INSTRUCTIONS FOR USE

09/2017
 INTRODUCTION

2
INTRODUCTION

CONTENTS
1 INTRODUCTION ........................................................................................... 4

2 SYMBOLS AND DEFINITIONS ...................................................................... 5

2.1 Symbols ....................................................................................................................................... 5
2.2 Definitions .................................................................................................................................... 6

3 IMPORTANT SAFETY INSTRUCTIONS ........................................................... 7

4 RADIO FREQUENCY SYSTEM SAFETY CONSIDERATIONS .......................... 8

4.1 RF Effects on Electronic Equipment....................................................................................... 8
4.2 RF Effects in Potentially Explosive Atmospheres ................................................................. 9
4.3 Effects on Human Tissue ......................................................................................................... 9
4.4 RF Effect on Pacemakers ........................................................................................................ 9
4.5 Electrical Safety .......................................................................................................................... 9

5 GENERAL SPECIFICATIONS ....................................................................... 10

5.1 Specifications............................................................................................................................ 10
5.2 Accessories ............................................................................................................................... 11
5.2.1 Standard accessories ...................................................................................................... 11
5.2.2 Optional accessories ........................................................................................................ 11

6 OPERATING PRINCIPLE & FUNCTIONS ...................................................... 12

7 POSITIONING OF THE SPLASH GUARD ...................................................... 14

7.1 Stand-alone set-up (Positioning of the splash guard) ...................................................... 14
7.2 Cascade set-up ....................................................................................................................... 14

8 INSTALLATION/OPERATION INSTRUCTIONS .............................................. 15

8.1 Stand-alone set-up ................................................................................................................. 15
8.2 Cascade set-up ....................................................................................................................... 16

9 CLEANING AND MAINTENANCE ................................................................. 19

9.1 General cleaning ...................................................................................................................... 19
9.2 Cleaning of the sealing head ................................................................................................. 19
9.3 Cleaning the self-adhesive splash guard ........................................................................... 20
9.4 Technical support and service information. ....................................................................... 20

10 DISPOSAL (END OF LIFE) ........................................................................ 21

11 ERROR LED INDICATIONS ...................................................................... 22

12 DECLARATION OF CONFORMITY ........................................................... 23

3
 INTRODUCTION

1 INTRODUCTION
T-SEAL II(+) Terumo Tube Sealing Device is intended to seal PVC tubing by means of a high
frequency dielectric heating system.

The Hand Unit with the integrated cable (accessory) can also be connected with the T-SEAL
II+. It is a complete inbuilt sealing head and ready to operate.

Throughout this manual, information that only applies to T-SEAL II+ will be printed in Italics.
This information doesn’t apply to T-SEAL II.

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SYMBOLS AND DEFINITIONS

2 SYMBOLS AND DEFINITIONS

2.1 Symbols

Catalogue number Serial number

Temperature limitation This way up

Fragile, handle with care Keep dry

Attention, see instructions for use EC representative

Separate collection for electrical and

electronic equipment (European Manufacturer

symbol)

This product complies with the requirements of EC Directive 2014/30/EU for

electromagnetic compatibility in accordance with EN 61326-1 and those of
the EC Directive 2006/42/EC for machinery in accordance with EN 61010-1
for laboratory equipment.

Rx Only

CAUTION • Federal (U.S.A.) law restricts this device to sale by or on the order of
a physician.

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 SYMBOLS AND DEFINITIONS

2.2 Definitions
Definitions following European standard EN 55011 and International standard CISPR 11:
EMC Class A Equipment: Equipment suitable for use in all establishments other than
domestic and those directly connected to a low voltage power supply network which supply
buildings used for domestic purposes.

EMC Group 2 Equipment: ISM (Industrial, Scientific, Medical) equipment in which

radiofrequency energy is intentionally generated and/or used in the form of electromagnetic
radiation for the treatment of material, electro-discharge machining equipment and arc
welding equipment.

Definition following U.S. regulation FCC Part 15:

Class A digital device: A digital device that is marketed for use in a commercial, industrial or
business environment, exclusive of a device which is marketed for use by the general public
or is intended to be used in the home.

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IMPORTANT SAFETY INSTRUCTIONS

3 IMPORTANT SAFETY INSTRUCTIONS

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.

The general safety information in the manual is for operating personnel. Specific notes,
cautions and warnings are found throughout the manual where applicable. Please read the
Instructions For Use (IFU) carefully before use.

If the equipment is not used following the intended use described in this manual, the
manufacturer will not guarantee the results nor the safety of the device and shall not be
liable.
Any changes or modifications to this equipment not expressly approved by the manufacturer
could void the user’s authority to operate this equipment.

WARNINGS • Never use the T-SEAL II(+) or the Hand Unit accessory on blood
bags or tubing that are connected to a donor.

• In order to avoid contamination, the user is recommended to

wear gloves. Refer to your institution’s Standard Operating
Procedures prior to use. When a leakage has occurred, the T-
SEAL II(+) should be cleaned according to the cleaning
procedure in section 9.

• Use of cables and accessories, others than those specified, may

result in increased emission or decreased immunity of the
equipment or system. Only accessories designed for use with T-
SEAL II(+) should be used.

Caution • This equipment is not intended for use in residential environments

and may not provide adequate protection to radio reception in
such environments.

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 RADIO FREQUENCY SYSTEM SAFETY CONSIDERATIONS

4 RADIO FREQUENCY SYSTEM SAFETY CONSIDERATIONS

There are a variety of instruments that incorporate the use of radio frequency (RF) for
sealing, welding, or for thermoplastics. Typical uses include the sealing of blood bag tubing.
When in operation, these RF instruments emit radio frequency energy to people, other
instruments, and equipment located in close proximity. The T-SEAL II(+) Terumo Tube
Sealing Device is an RF instrument that operates at a frequency authorized by the Federal
Communications Commission (FCC) and the International Telecommunications Union (ITU)
for industrial, scientific, and medical (ISM) use.
The following is an advisory regarding RF instrument use and associated safety
considerations.

4.1 RF Effects on Electronic Equipment

• EN 55011/CISPR 11 Class A Notice:
This is a Class A product. In a domestic environment this product may cause radio
interference, in which case the user may be required to take adequate actions.
• ICES-001 Notice:
This ISM equipment complies with the Canadian Interference-Causing Equipment
Standard ICES-001.
• FCC Class A Notice:
The device complies with Part 15 of the FCC Rules. Operation is subject to the
following two conditions:
o This device may not cause harmful interference, and
o This device must accept any interference received, including interference that
may cause undesired operation.

NOTE • This equipment has been tested and found to comply with the
limits for a Class A digital device, pursuant to part 15 of the FCC
Rules. These limits are designed to provide reasonable protection
against harmful interference when the equipment is operated in a
commercial environment. This equipment generates, uses, and
can radiate radio frequency energy and, if not installed and used
in accordance with the instruction manual, may cause harmful
interference to radio communications. Operation of this
equipment in a residential area is likely to cause harmful
interference in which case the user will be required to correct the
interference at his own expense. While most modern electronic
equipment and instruments provide shielding from RF energy,
improperly shielded electronic devices operating in close
proximity to an RF instrument may be affected. If interference is
suspected, appropriate electronic shielding, moving equipment
further away from the RF instrument or operating from a different
electrical circuit may be necessary.

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RADIO FREQUENCY SYSTEM SAFETY CONSIDERATIONS

4.2 RF Effects in Potentially Explosive Atmospheres

Do not operate the T-SEAL II(+) in an area with a potentially explosive atmosphere. It is
possible for the RF electrodes to arc (an electrical discharge from the jaws (electrodes) that
may be seen as a spark), initiating an explosion or fire.

4.3 Effects on Human Tissue

Misuse or direct contact between tissue and RF electrode(s) can result in severe burns.

4.4 RF Effect on Pacemakers

There is no evidence that the T-SEAL II(+) interferes with the function of modern cardiac
pacemakers.

4.5 Electrical Safety

The T-SEAL II(+) meets or exceeds appropriate electrical safety standards, and poses no
electrical shock hazard when used with properly fused and grounded outlets.

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 GENERAL SPECIFICATIONS

5 GENERAL SPECIFICATIONS
5.1 Specifications
Product code ME-TSEAL2B (T-SEAL II)
ME-TSEAL2P (T-SEAL II+)

Tube specification PVC tubing up to 6.0mm OD

Sealing time 0.5 up to 3s depending on tubing

Size (W x H x D) T-SEAL II(+): 70 mm x 215 mm x 335 mm

Weight kg (lb) T-SEAL II: 3.6 kg (7.9 lb)

T-SEAL II+ : 3.7 kg (8.2 lb)

Voltage input 100 – 240 VAC

Voltage output 100 – 240 VAC

CAUTION: Voltage output only to be used for cascade
connection to another T-SEAL II(+)

Voltage output current Max 10 A–240 VAC; max 16 A–100 VAC

Voltage frequency 47-63 Hz

Power consumption Max. 400 VA

RF output 150 W max / 50 Ω / 40.68 MHz

Internal fuses 2 x 4 AT – 250 V

Communication ports 2 x RJ-45 (COM in & COM out)

Communication ports only to be used for cascade connection
to another T-SEAL II(+)

Operating conditions 10 up to 40°C (50 up to 104 °F)

10 up to 80% Rh (non-condensing)

Storage conditions -20 up to +70 °C (-4 up to 158 °F)

10 up to 90% Rh (non-condensing)

Pollution degree 2

Noise level (continuous) None

Degree of protection IPX0

Maximum altitude 2000m

Compliance to Directives / 2006/42/EC (Machinery)

Legislations 2014/30/EU (EMC)

EMC Classification Group 2 (EN 55011/CISPR 11)

Class A (FCC Part 15)

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GENERAL SPECIFICATIONS

Compliance to Standards ICES-001

FCC Part 15 & Part 18
EN 61010-1 / IEC 61010-1
EN 61326-1:2013

Legal manufacturer Terumo BCT Inc.

10811 W. Collins Ave.
Lakewood, CO 80215, USA

WARNING • This is a Class A product. In a domestic environment this

product may cause radio interference, in which case the user
may be required to take adequate actions.

5.2 Accessories

5.2.1 Standard accessories

• AC power cord
• Instructions for use - English
• Instructions for use other languages: on CD-ROM
• Warranty card
• Self-adhesive transparent splash guard.

5.2.2 Optional accessories

• Cascade cable kit (8METSEAL2CAB):

o 1 short power cable
o 1 short communication cable
• Cascade connector kit (8METSEAL2COM):
o 2 communication termination plugs
• Splash guard kit (8METSEAL2SG):
o 5 self-adhesive transparent splash guards
• Hand Unit (8METSM001)
o IFU of accessory inserted in T-SEAL II+ packaging.

WARNING • N ev er use the T-SEAL II+ or the Hand Unit accessory on

tubing or blood bags that are connected to a donor.

NOTE • Do not try to connect other portable sealers than the Terumo BCT
Hand Unit to the T-SEAL II+.

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 OPERATING PRINCIPLE & FUNCTIONS

6 OPERATING PRINCIPLE & FUNCTIONS

The T-SEAL II(+) Terumo Tube Sealing Device is intended to seal different types of PVC
tubing with an outer diameter of max 6.0 mm by means of a high frequency dielectric
heating system.

When tubing is inserted between the electrodes of the sealing head it is optically detected.
The tubing is gripped by tension relief arms in order to prevent any traction on the tube.
Then, the moving electrode from the sealing head goes forward and squeezes the tubing. At
this moment, the high frequency is activated and melts the tubing into two separable parts.
Depending on the kind of tubing, the sealing process will be completed in a time varying
between 0.5 and 3.0 s.

Error LED

Status LED ring

Sealing head

Connector for T-SEAL II(+) • front side

Hand Unit

Tension relief arms

Optical detection
sensor

Moving electrode
T-SEAL II(+) • detail of sealing head with removed front part

NOTE • The front part of the sealing head is the fixed electrode.

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OPERATING PRINCIPLE & FUNCTIONS

Identification label
COM IN

COM OUT On/off switch

Power inlet

Carrying handle
Power outlet

T-SEAL II(+) • back side

Back support wing

Positioning wing

Positioning pins

Front support wing

T-SEAL II(+) • bottom side

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 POSITIONING OF THE SPLASH GUARD

7 POSITIONING OF THE SPLASH GUARD

7.1 Stand-alone set-up (Positioning of the splash guard)
1. Remove the protective film from the back of the self-adhesive splash guard.
2. Attach the splash guard to the front of the T-SEAL II(+) as shown in the picture below.

Self-adhesive transparent
splash guard

7.2 Cascade set-up

1. Remove the protective film from the back of the self-adhesive splash guard.
2. Attach the splash guards to the front of the T-SEAL II(+) devices as shown in the
pictures below.

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INSTALLATION/OPERATION INSTRUCTIONS

8 INSTALLATION/OPERATION INSTRUCTIONS
8.1 Stand-alone set-up

1. Unfold the front and back support wings.

2. Place the T-SEAL II(+) on a flat surface, out of direct sunlight.
3. Connect the T-SEAL II(+) to the power supply by connecting the AC power cord to the
AC power inlet and then to an earthed AC socket.
4. Switch the power switch on the backside of the device to “I”. The device will perform
its self-check and the status LED ring will blink green – off – green.
When the self- check is finished and the device is ready for sealing the LED ring will
continuously illuminate green.
5. Take the tubing and slide it against the front cover of the sealing head into the slit.
6. The tubing will be automatically detected and sealed.
7. During the sealing process, the status LED ring will be orange, indicating RF activation.
When the RF activation is finished, the status LED ring will flicker once in orange. It will
automatically turn green again when the entire process is finished.
8. Remove the tubing from the sealing head.
9. Pull at both ends to separate the seal.

CAUTIONS • Make sure that the tubing and the sealing head are dry before
sealing. Do not stretch the tubing when sliding it into the slit of the
sealing head.

• Do not interchange sealing heads between devices. This may lead

to malfunctioning.

• Do not place the T-SEAL II(+) in direct sunlight. This may lead to
malfunctioning.

• Never touch the area behind the sealing head while a seal is being
made or while the status LED ring is orange.

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 INSTALLATION/OPERATION INSTRUCTIONS

8.2 Cascade set-up

1 2 … 8

1 2 7

1. Unfold the appropriate positioning and support wings based on the amount of
units and according
… to the following table:
segment length
7 & 8 cm 9 & 10 cm 11 cm
front support wing open open open
T-SEAL II(+)
positioning open open open
n°1
back support wing closed open open
T-SEAL II(+) front support wing closed open open
n°2
positioning open open open
-
n°(x-1) back support wing closed open open
front support wing closed open open
T-SEAL II(+)
positioning open open closed
n°x
back support wing open open open
With x = a number with a maximum of 8.

2. Fix the segment length by positioning the T-SEAL II(+) devices in the correct slot
of the positioning wing.
The segment length can be modified in steps of 1 cm. Minimum segment length is
7 cm (first slot position), maximum segment length is 11 cm (last slot position).

Positioning wing

open
Back support wing

open
open

Front support wing

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INSTALLATION/OPERATION INSTRUCTIONS

3. Decide whether the cascade needs to seal from left to right (leader on the left-hand
side) or from right to left (leader on the right-hand side). Sealing should always
proceed towards the bag in order to avoid pressure build-up inside of the tube
segments.
The leader is selected by inserting a communication termination plug into its
COM IN. The last follower should have a communication termination plug into its
COM OUT.
4. Connect the T-SEAL II(+) leader to the power supply by connecting the AC
power cord to the AC power inlet and then to an earthed AC socket.
5. Insert a communication termination plug into the COM IN of the leader.
6. Interconnect the following T-SEAL II(+) device with the leader by utilizing the short
power cable and short communication cable.
Connect the short communication cable from the COM OUT of the leader to the
COM IN of the first follower.
Connect the short power cable from the power out of the leader to the power in
of the first follower.
Make sure the power switch is in the ‘I’ position.

Communication
termination plug in
COM IN indicates
LEADER

Short
Communication
cable

AC power input Short power cable

7. Interconnect also the following followers by connecting the short power cable
and communication cables as described above.
Make sure that all the power switches are in the ‘I’ position.
8. Insert a communication termination plug into the COM out of the last follower.
9. After switching on the T-SEAL II(+) leader, all devices will automatically be powered
on.
10. When the status LED rings are all green and none of the error LED’s are
illuminated, the devices are ready to make segments.
11. Place the tubing against the front covers of the sealing heads and slide the tubing
downwards into the slits. Do this slantingly, in a way the tubing enters last into the
leader. Be careful not to stretch the tubing or to put any stress on it.

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 INSTALLATION/OPERATION INSTRUCTIONS

12. Each sealing head will separately detect its piece of tubing and cascade sealing
will only be activated when all the individual tube sections are detected.
If tubing is not correctly detected in one or more of the sealing heads, the error
LED will be illuminated on the involved devices and on the leader. In this case,
remove the tubing out of all the heads and start over.
13. All the T-SEAL II(+) devices will seal one by one, starting from the leader. A small
delay is programmed in between the sealing of the successive units to minimize
pressure build-up inside of the tubing.
14. During the sealing process the LED rings will turn orange. When the process is
finished, they will turn green again.
15. Remove the tubing when all the LED rings turned green.

WARNING • T-SEAL II(+) 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.

CAUTIONS • Make sure that the tubing and the sealing head are dry before
sealing.

• Do not stretch the tubing when sliding it into the slit of the sealing
head.

• The sealing should always proceed towards the bag to avoid

pressure build-up inside of the tube segments.

• Do not interchange sealing heads between devices. This may lead

to malfunctioning.

• Do not place the T-SEAL II(+) in direct sunlight. This may lead to
malfunctioning.

• Never touch the area behind the sealing head while a seal is being
made or while the status LED ring is orange.

• A cascade set-up of maximum 8 T-SEAL II(+) devices can be

made.

• Do not interchange other devices than T-SEAL II(+) (with or without

a Hand Unit accessory) devices in a cascade set-up.

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CLEANING AND MAINTENANCE

9 CLEANING AND MAINTENANCE

WARNINGS • Before cleaning the T-SEAL II(+) or removing the sealing head,
switch off the power, disconnect the power cord and, if needed,
disconnect the Hand Unit from the T-SEAL II+.

• Never power on the T-SEAL II(+) device, when the sealing head is
not present or is incorrectly positioned.

9.1 General cleaning

Always keep the T-SEAL II(+) clean.
Clean the surface of the T-SEAL II(+) with a soft cloth soaked in mild detergent or a
chlorhexidine gluconate solution of less than 0.5% and well squeezed. When cleaning the T-
SEAL II(+), be careful not to spill any cleaning solution inside the instrument. If this happens,
do not operate the instrument.
If any liquid (blood, blood product, cleaning solution or other fluid) have entered into the
internal components of the machine, please contact technical support and service. Do not
attempt to open the device.

9.2 Cleaning of the sealing head

Keep the sealing head dry. A dirty sealing head or a dirty optical detection sensor can lead to
bad seals and errors in tube recognition. If some liquid or dirt is spilled into the sealing head,
dry and clean the parts immediately with a soft tissue.
To clean the electrodes and the optical detection sensor, remove the sealing head and clean
the optical electrode, the removable electrode and fixed electrode with a cotton swab.

Dot

Reposition:
Remove:
A. Insert head
1. Switch off
B. Turn head right while
2. Push head
pushing until it locks into
3. Turn left
place (audible click).
4. Pull head out
C. Switch on

Remove and reposition front electrode

When the dot is at the top side and the green LED ring lights up, the sealing head is correctly
positioned and the device is ready for sealing.

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 CLEANING AND MAINTENANCE

9.3 Cleaning the self-adhesive splash guard

If any liquid (blood, blood product, cleaning solution or other fluid) is spilled on the splash
guard, wipe it off immediately with a soft cloth soaked in mild detergent or a chlorhexidine
gluconate solution of less than 0.5% and well squeezed.

CAUTIONS • Abrasive solutions such as acetone or ammonia and organic

solvents (except for alcohol) shall not be used!

• Do not dip the units in liquid, as they are not waterproof.

Intruding liquid causes malfunction.

• Do not use sharp edged tools as they can damage the units.

9.4 Technical support and service information.

To assure safe and trouble free operation, please have your T-SEAL II serviced at least every
12 months, depending on the frequency of use. If you experience a system failure, please call
Terumo BCT or your Terumo BCT representative for servicing. When calling for servicing,
please be able to describe the problem and have the serial number available so that faster
handling of the repair will be possible.
Do not attempt to dismantle or repair the unit. Only qualified personnel are authorized to
service the machine.

Technical support – Call number from

A 0800-293711 B 0800-94410 DK 808-80701

SF 0800-115226 IRL 1800-553224 CH 0800-563594

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

USA 877-339-4228 CA 877-722-8411

Other countries call +32 16 39 14 00 at international rates.

E-mail: meservice@terumobct.com

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DISPOSAL (END OF LIFE)

10 DISPOSAL (END OF LIFE)

Electrical and electronic equipment (EEE) contains materials, components and substances
which can be dangerous to the environment and harmful to human health if waste electrical
and electronic equipment (WEEE) is not disposed of separately.

At end of life, please dispose of this device according to your local regulations or contact
your local Terumo BCT office (see above: technical support).

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11 ERROR LED INDICATIONS
By means of the red error LED, a problem with the T-SEAL II(+) device will be indicated. If
after following the corrective actions listed below the problem persists, please call Terumo
BCT for servicing.
Following indications can be given:
Error LED indication
Error LED lights up after switching
on the device.
Error LED lights up during use.
Error LED lights up for 2 seconds.
Error LED lights up for 2 seconds on
leader and follower.
Error LED flashes (7 Hz) for 5 sec.
After switching on the device.
Error LED flashes (1 Hz) 2 times.
Error LED flashes (1 Hz) 3 times.
Error LED lights up after switching
on a follower.
22
Possible cause
No detection of closed electrodes
in the sealing head.
The temperature in the sealing
head is too high.
The thermistor is broken or not
mounted.
The sealing process took longer
than expected and the seal might
be incomplete.
Direct contact or a spark between
the electrodes of the sealing head.
One or more of the followers did
not detect tubing after the seal
command came from the leader.
The device passed the
programmed servicing time
(service counter alarm).
The sealing head and/ or optical
sensor is dirty.
The optical sensor is broken or out
of calibration.
The sealing head is not or is
incorrectly placed.
The optical detection sensor is
broken.
The sealing head magnet is out of
place.
Followers were not switched on
before switching on the leader.
ERROR LED INDICATIONS
Corrective action
1. Remove the tubing from the
sealing head (if present).
2. Clean the electrodes (they might
be dirty).
Wait a few minutes for the unit to
cool down.
Contact Terumo BCT for servicing.
1. Check the tubing for complete
sealing. If the seal is not complete,
don’t pull the ends apart.
2. If the sealer is placed in a cold
environment, move it to a warmer
location.
3. Clean the electrodes and make
sure that these are dry.
1. Check the correct placement of
the tubing in the sealing head.
2. Clean and dry the electrodes.
1. Check the correct placement of
the tubing in the sealing head.
2. Clean the sealing head and the
optical sensor.
Contact Terumo BCT for servicing.
Clean the sealing head and the
optical sensor.
Contact Terumo BCT for servicing.
Place the sealing head correctly.
Contact Terumo BCT for servicing.
Contact Terumo BCT for servicing.
Switch off the leader and switch on all
the followers. Wait 20 seconds and
switch on the leader.
DECLARATION OF CONFORMITY

12 DECLARATION OF CONFORMITY
Legal Entity: Terumo BCT, Inc.

Address of Legal Entity: 10811 West Collins Avenue

Lakewood
Colorado, 80215
USA

Authorized Representative established in the Community

Terumo BCT Europe NV
Ikaroslaan 41
1930 Zaventem
Belgium
Tel: +32.2.715.05.90
Fax: +32.2.721.07.70

Product Name: Terumo tube sealing device (T-SEAL II / T-SEAL II+)

Product Class: The T-SEAL II(+) is classified as active laboratory equipment covered by
the below Machinery and EMC Directives, the Electromagnetic
Compatibility Directives and the Directives on Electrical equipment
designed for use within certain voltage limits.

This declaration of conformity is issued under the sole responsibility of the manufacturer.

We hereby declare that the T-SEAL II catalog numbers ME-TSEAL2A, ME-TSEAL2B and ME-
TSEAL2P, comply with the following European Council Directives:

- European Council Directive 2006/42/EC concerning Machinery

- European Council Directive 2014/30/EU concerning Electromagnetic Compatibility
- European Council Directive 2014/35/EU concerning Electrical equipment designed for use
within certain voltage limits

In addition to the following European Standards:

EN 61010-1:2010, Safety requirements for electrical equipment for measurement, control and
laboratory use – Part 1: General Requirements

EN 61326-1:2013, Electrical equipment for measurement, control and laboratory use - EMC
requirements. General requirements.

23
 DECLARATION OF CONFORMITY

FOR INFORMATION ABOUT TERUMO BCT PRODUCTS

If this product should fail to perform as intended, immediately stop use and contact the
nearest office of TERUMO BCT.

Terumo BCT, Inc. Terumo BCT (Asia Pacific) Ltd.

10811 West Collins Avenue
Lakewood, Colorado 80215-4440
USA
USA Phone: 1.877.339.4228
Phone: +1.303.231.4357
Fax: +1.303.542.5215
Room 3903-3903A, 39/F
ACE Tower, Windsor House
311 Gloucester Road
Causeway Bay, Hong Kong
Phone: +852.2283.0700
Fax: +852.2576.1311

Terumo BCT Europe N.V. Terumo BCT Japan, Inc.

Europe, Middle East and Africa
Ikaroslaan 41
1930 Zaventem
Belgium
Phone: +32.2.715.05.90
Fax: +32.2.721.07.70
Takanawa Park Tower 13F
20-14, 3-chome
Higashi Gotanda, Shinagawa-ku
Tokyo 141-0022, Japan
Phone: +81.3.6743.7890
Fax: +81.3.6743.9800

Terumo BCT Latin America S.A.

La Pampa 1517 – 12th Floor
C1428DZE
Buenos Aires
Argentina
Phone: +54.11.5530.5200
Fax: +54.11.5530.5201

TERUMOBCT.COM

LCT-7011en

Terumo BCT, Inc.

10811 W. Collins Ave.,
Lakewood, CO 80215, USA

®: Registered trademark
©: Copyright 2017 Terumo BCT, Inc. – All rights reserved

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