Terumo Penpol TSCD-II USER MANUAL

OPERATING INSTRUCTIONS
Read this manual carefully before use. Use this instrument as instructed.
03/2020
CONTENTS
CONTENTS
IMPORTANT SAFETY INFORMATION ................................................................. 4

1 FEATURES AND SPECIFICATIONS ............................................................... 5
1.1 Features ...................................................................................................................................... 5
1.2 Specifications ............................................................................................................................. 5
1.3 Symbols ....................................................................................................................................... 6
2 PHYSICAL DESCRIPTION ............................................................................ 7
2.1 Front of TSCD®-II ........................................................................................................................ 7
2.2 Clamps......................................................................................................................................... 7
2.3 Rear of TSCD®-II ......................................................................................................................... 8
2.4 Control panel .............................................................................................................................. 9
2.5 Accessories ................................................................................................................................ 9
2.6 Optional Accessories .............................................................................................................. 10
3 OPERATION OF TSCD®-II ............................................................................ 11
3.1 Principles of operation ............................................................................................................. 11
4 GENERAL WARNINGS AND CAUTIONS ...................................................... 12
4.1 General warnings and cautions ............................................................................................ 12
4.2 Storage ...................................................................................................................................... 12
4.3 Cleaning procedure ................................................................................................................ 13
4.4 Periodical maintenance .......................................................................................................... 13
5 PROCEDURE FOR USE ............................................................................... 14
5.1 Operational flow chart ............................................................................................................. 14
5.2 Replacing the wafer cassette ................................................................................................ 18
5.3 Snap on the blood bag support ............................................................................................ 18
5.4 Detachable cover .................................................................................................................... 19
5.5 Wafer disposal ......................................................................................................................... 20
5.6 Cleaning procedure ................................................................................................................ 21
5.7 Replacing the air filter .............................................................................................................. 21
5.8 Parameter setting mode ....................................................................................................... 22
6 TROUBLESHOOTING ................................................................................. 24
6.1 Prompts on the display .......................................................................................................... 24
6.2 Troubleshooting table ............................................................................................................ 28
6.3 Procedure to repair a wafer jam .......................................................................................... 28
7 TECHNICAL SUPPORT ............................................................................... 32
8 DISPOSAL (END OF LIFE) .......................................................................... 33
9 EU DECLARATION OF CONFORMITY ......................................................... 34
3
IMPORTANT SAFETY INFORMATION
IMPORTANT SAFETY INFORMATION

The TSCD®-II Sterile Tubing Welder has been designed for use in the storage and handling of blood
products. If the instrument or procedures are used for purpose over and above the capabilities
specified herein, confirmation of their validity and suitability should be obtained; otherwise the
manufacturer will not guarantee the results and assumes no obligation or liability. It is the user’s
responsibility to follow all procedures outlined in this manual.
NOTES, PRECAUTIONS or CAUTIONS and WARNINGS within the text of this manual are used to
emphasize important and critical instructions.
NOTE • Highlights essential information.
CAUTION • Includes information regarding any special care to be exercised by the

operator for the safe and effective use of the device.
WARNING • Informs the operator of a hazard or an unsafe practice that could

result in personal injury, affect the operator’s health or contaminate the
environment.
WARNINGS • Failure to follow all operating instructions can result in leaking, non-
sterile welds.
• Check each weld carefully. If, for any reason, the weld leaks, the
sterility of your system may be compromised, resulting in
contamination. Handle appropriately.
• The TSCD®-II is an electro-mechanical instrument designed for

reliability. However, electrical or mechanical failures may occur which
could result in leaking, non-sterile welds.
• Wafers can be used only once. Wafers cannot be reused. Be sure to

dispose of all used wafers properly. Treat wafers that have been used
on tubing containing blood products as biological waste, and handle
according to proper infectious disposal procedures.
• Be careful not to spill any liquid into the TSCD®-II. Liquid inside the
instrument can cause irregular operation and/or incomplete welds.
• Do not use any cable other than the included AC power cable.
• Do not touch the clamps during the realignment as the left clamp
moves forward. Fingers may get caught and injured.
4
FEATURES AND SPECIFICATIONS
TROUBLESHOOTING
1 FEATURES AND SPECIFICATIONS

1.1 Features
The Terumo BCT TSCD®-II is a system for automatically connecting two sections of PVC tubing in a
sterile manner.
• The TSCD®-II has a compact design and is portable.

• The system automatically connects two pieces of tubing in three easy steps.
• The system is able to connect two pieces of tubing empty or filled with solution such as blood
or medicine.
• An LCD display indicates operating status, guidance for the operators and error messages.
• Wafers are automatically replaced. Used wafers are automatically disposed of into a disposal
box without any external contact.
• Wafers are packed in cassettes, which assure easy replacement.
1.2 Specifications
Name of product: ...................................... TERUMO STERILE TUBING WELDER TSCD®-II
Product code: ............................................ ME–SC203AH
Tubing material: ......................................... Polyvinyl chloride (PVC)

Tubing associated with: Blood bags
Leukocyte reduction filters
Apheresis Kits
AVF Needles
Tubing sizes: ............................................... Outside diameter: 3.9 - 4.5 mm

Inside diameter: 2.9 - 3.1 mm
Wafer used: ................................................ TSCD® Wafer, model number SC*W017
Operating condition: .................................. Indoor use only

Ambient temperature 10°C to 40°C (50°F to 104°F)
Relative humidity 10% to 80%, non-condensing
Maximum Altitude 2000 m (6562 ft)
Storage/transport condition:.................... Ambient temperature - 10°C to 50°C (14°F to 122°F)

Relative humidity 10% to 95%, non-condensing
Pollution degree: ........................................ 2 (according to IEC 664-1)
Overvoltage category Category II
Power supply: ............................................ AC 100V±10% to AC 240V±10% 50/60 Hz, 3.0 A
Noise level: .................................................. < 65 dBA
External dimension: ................................... W224 x H177 x D342 mm
Weight: ........................................................ Approx. 6.5 kg (14.33 lbs)
Accessories with TSCD -II: ......................

®
AC power cable, 2 bag supports, 2 Fuses (250V 4.0A) Slow Blow,
1 cassette of TSCD® wafers, 1 air filter, 2 wafer jam repair tools,
Operating Instructions, Warranty Card
Communication ports: .............................. RS-232 for TOMEs (Terumo Operational Medical Equipment
software)
5
FEATURES AND SPECIFICATIONS
1.3 Symbols
Product code Serial number
Stacking limit by 3 This way up
Handle with care Keep dry
Attention, see instructions for use EC representative
Temperature limitation Relative humidity limitation
Keep away from heat and sunlight Manufacturer
Separate collection for electrical and electronic equipment (European symbol)
We herewith declare that this product complies with the requirements of EC Directive
2014/30/EU for electromagnetic compatibility in accordance with EN 61326-1, and
those of EC Directive 2006/42/EC for machinery in accordance with EN 61010-1.
6
PHYSICAL DESCRIPTION
TROUBLESHOOTING
2 PHYSICAL DESCRIPTION
2.1 Front of TSCD®-II
Figure 1
• Cover
• Display
• Clamps
• Disposal box
Used TSCD® wafers are automatically
discarded in this box.
2.2 Clamps
Figure 2
• Clamp covers
• Slots
Tubing is placed in these slots.
• Wafer jam repair holes
7
2.3 Rear of TSCD®-II

Figure 3
• Power switch
• AC inlet
• Fuse holders
(Fuse 250V 4.0A Time Lag (2 pieces))
(Fuse type and rated voltage: T4AH250V)
• RS485 connectors
• RS232C Connector
• Handle
WARNINGS • To avoid electric shock, protective grounding conductor in the power

cord must be connected to the ground.
• Do not remove covers. Refer servicing to qualified personnel only.
• Disconnect input power before replacing fuse.
• To avoid fire hazard, replace only with fuse of specified type and rate.
8
TROUBLESHOOTING
2.4 Control panel
Figure 4
• ”ALARM” indicator lamp

Lights up when an alarm occurs.
• LCD DISPLAY
Indicates Operating Status, Error messages
and gives Guidance.
Illuminates when power is on.
• “EJECT” button
Press down this button and the wafer cassette
will be released from its compartment.
• Wafer cassette compartment

Compartment housing the wafer cassette.
• “CLAMPS”
Set tubing in the front and rear slots and lock the
jaws so that the weld cycle can begin. After the
cycle is complete, the tubing in the left front slot is
connected to the tubing in the right rear slot.
• ”RESET” button
Press this button to realign the clamps after a
weld and to automatically replace a wafer.
This button is also used to reset the machine
when the alarm sounds.
• “START” button
Press this button after the tubing has
been locked in the clamps.
2.5 Accessories
• AC power cable
• Bag-support (2 pieces)
• Fuse 4.0A Slow Blow (2 pieces)
• TSCD® wafers (1 cassette)
• Air filter (1 sheet of filter material)
• Operating Instructions
• Warranty card
• Wafer jam repair tool (2 pieces)
9
2.6 Optional Accessories

TOMEs (Terumo Operational Medical Equipment software)
TOMEs is an information system which, when connected to the TSCD®-II, is able to store all
information regarding the welding process and the items being welded.
In order to connect TSCD®-II to TOMEs, following items are needed:
• Accessory kit for TSCD®-II (2ME05TSC001) or Accessory kit PoE for TSCD®-II (2ME05TSC002): 1
needed per connected TSCD®-II.
• TOMEs hardware + software (2METOMES)
or TOMEs software to install on customer server (2METOMESINST).
• TOMEs Stations license (2METOMESSTA): 1 per two stations.
10
OPERATION OF TSCD®-II
TROUBLESHOOTING
3 OPERATION OF TSCD®-II
3.1 Principles of operation
In this system, two lines of tubing, set parallel to each other, are cut with a TSCD® wafer which has
been heated to approximately 300°C (572°F). At this temperature one section of cut tubing is moved
along the heated wafer until it reaches an equal plane with the other section of tubing. Once the two
sections of tubing are directly opposite to each other, the wafer returns to its original position so that it
is no longer between the two tubing sections. With the wafer lowered, the clamps press the ends of
the tubing together and hold them in that position until the PVC has fused, and the joint has cooled
enough to be handled.
1. A TSCD® wafer which has been heated to approximately 300°C (572°F), cuts two sections of
tubing which are held in the clamps (see Figure 5A).
2. The tubing section held in clamp #1, is moved along the wafer until it is aligned directly across the
tubing section held in clamp #2. At this point the wafer is lowered, the clamps are pushed
together, and the two sections of tubing are butted up against each other so that the weld is
completed (see Figure 5B).
Figure 5A
Figure 5B
Clamp #1 Clamp #2
TSCD® Wafer
(heated
to approximately
300°C (572°F))
Clamp #1
Clamp #2
11
GENERAL WARNINGS AND CAUTIONS
4 GENERAL WARNINGS AND CAUTIONS

4.1 General warnings and cautions
WARNINGS • Never use the system on tubing that is connected to a patient.
• Visually check each connection. If a leak is detected, consider the unit

contaminated and handle appropriately.
• Wafers are designed for single use only. Wafers cannot be reused.
CAUTIONS • Do not use this system to connect tubing that does not fall within the
ranges specified under section 1.2 “Specifications”.
• Do not use the TSCD®-II near a high frequency power source.
• Used wafers are considered as biohazard, dispose of them properly

according your local disposal procedures.
• A system failure can occur if any foreign matter (solid or liquid)

comes into contact with the internal components of the TSCD®-II.
If such a situation occurs, have the unit serviced by an authorized
repair service before further use.
• The TSCD®-II is an electro-mechanical instrument designed for

reliability. However, electrical or mechanical failures may occur if the
TSCD®-II is dropped or handled roughly. PLEASE HANDLE WITH
CARE.
• A part of a wafer may stick out of the wafer jam repair holes. Do not
touch the wafer jam repair holes because a wafer can damage your
fingers.
• A used wafer jam repair tool is considered as biohazard and must be

disinfected using medical alcohol or a chlorhexidine gluconate
solution of less than 0.5%.
4.2 Storage
CAUTIONS • Avoid high temperature or humidity during storage. See section 1.2
“Specifications” storage condition.
• Do not store in areas that are subject to vibration, that are excessively
dusty, or where the TSCD®-II could be exposed to corrosive gas.
• Long term exposure to ultra-violet radiation may cause the external

surface to discolor.
12
GENERAL WARNINGS AND CAUTIONS
TROUBLESHOOTING
4.3 Cleaning procedure

The TSCD®-II is designed for minimum care. Always keep the TSCD®-II clean. Surfaces of the instrument
may be cleaned with a damp cloth and a neutral detergent.
WARNINGS • Turn the power off and disconnect the TSCD®-II before cleaning.
• When cleaning the TSCD®-II, be careful not to spill any cleaning

solutions inside the instrument. If this occurs, do not operate the
instrument.
• Professional cleaning and service is required if any liquid (blood,

blood product, cleaning solution or other fluid) is spilled into the
internal components of the machine.
CAUTIONS • Clean the surface of the TSCD®-II with soft clots saturated with
medical alcohol, neutral detergent or a chlorhexidine gluconate
solution of less than 0.5%. Abrasive solutions or organic solvents
shall not be used.
• Clean the clamps of the TSCD®-II with a cotton swab saturated with
chlorhexidine gluconate solution of less than 0.5%.
• Clean the wafer jam repair holes with a cotton swab saturated with
medical alcohol, neutral detergent or a chlorhexidine gluconate
solution of less than 0.5%. Abrasive solutions or organic solvents shall
not be used.
4.4 Periodical maintenance
CAUTIONS • To assure safe, trouble free service, please have your TSCD®-II
serviced once every twelve (12) months or every 20,000 wafers
used.
• If the TSCD®-II is dropped, service is recommended even if there is

no outward sign of damage.
• For servicing, please call Terumo BCT.
13
PROCEDURE FOR USE
5 PROCEDURE FOR USE

Please read « IMPORTANT SAFETY INFORMATION » and
« 4. GENERAL WARNINGS AND CAUTIONS » carefully before use.
5.1 Operational flow chart
1. Turn on TSCD®-II
2. Align clamps (push “RESET” button)
3. Place tubing in clamps
4. Close both clamps simultaneously
5. Start connection (push “START” button)
6. Read barcodes (optional) *
7. Connection completed
8. Check connection
For next connection
* Barcodes can be read before or during connection.
5.1.1 System set-up
1. Connect the system to the power supply. Connect the

AC power cable to the AC inlet at the back of the
TSCD®-II, and then to the earthed AC socket
(see Figure 6).
2. For connection of TOMEs to the TSCD®-II, carefully read

the Instructions for use of TOMEs.
3. Open the cover. The cover can be easily removed (See

section 5.4 “Detachable Cover”).
4. Turn the “POWER" switch on (see Figure 7). When the

TSCD®-II is turned on, the LCD display illuminates, a self Power switch Power cable RS232C
connector
check starts and 3 beeps will sound when the instrument Figure 6
is operating properly. The fan starts. The wafer holder is
warming up to 70°C to shorten the welding time
POWER ON SYSTEM CHECK
(see Figure 8).
Figure 7
14
PROCEDURE FOR USE
TROUBLESHOOTING
5. During warming up of the Wafer Holder portion,

maintenance information appears on the display. Each
message turns at 3-seconds interval.
HOLDER WARM UP
6. After maintenance information, the display shows wafer

holder temperature with increment of “*”. When the wafer
holder temperature reaches 70°C, a beep will sound and
Figure 8
the TSCD®-II is ready for operation.
7. Place the wafer cassette. (See section 5.2 “Replacing the Serial No.
Wafer Cassette”). 00000002
Serial number
Total Welds
CAUTION • Do not block the ventilator on 00000072
the rear (See Figure 9). Total welds
Next Maintenance
NOTES • If the LCD display does not Remain 00019928
illuminate, turn off the unit, Weld count by next maintenance
unplug the AC power cable Next Service

03/12/2005
and check the fuses.
Recommendation of next servicing
• A system failure is indicated if IS Communication

ON
the alarm lamp is flashing or
Communication with TOMEs through TSCD®-II
the buzzer is sounding
Soft Version
continuously. Turn off the unit
S00000
immediately and call Terumo Software version
BCT for servicing.
• If the wafer cassette in the

holder is empty, press the
“EJECT” button, pull out the
old cassette and replace it
with a new one (See section
5.2 “Replacing the Wafer
Cassette”).
• It takes approximately 3
minutes for warming up the Ventilation slits
Wafer Holder starting from
Figure 9
room temperature.
15
PROCEDURE FOR USE
5.1.2 Clamp Alignment
1. Press the “RESET” button.
CAUTIONS • The “RESET” button is not functioning when the wafer holder is
warming up.
• The left clamp realigns with the right clamp. The wafer is replaced at
the same time.
• The clamps shall not realign when they are already aligned.
• Do not press the “RESET” button to align clamps when tubing is

present in the slots.
NOTES • Pressing the “RESET” button with both clamps locked, activates the
buzzer and “OPEN CLAMP” is indicated on the display. The clamps
will not realign until both clamps are opened and tubing is removed
from the slots.
5.1.3 Tube placement
1. Set the tubing in the slots.
NOTE • Tube size: Outside diameter: 3.9 – 4.5 mm
Inside diameter: 2.9 – 3.1 mm
Material PVC (polyvinyl chloride)
CAUTIONS • Only tubing with specifications mentioned above should be used.
• Do not use this system to connect two pieces of tubing, of which

one or both are too short. If the tubing placed in the clamp slots
does not extend beyond the clamps or if the bag is in such a
position as to obstruct the movement of the clamp, the connection
may fail in weld strength or may leak.
2. Close clamp cover(s) completely until they are locked.
CAUTIONS • Failure to lock the clamp

covers may allow them to
open during the welding
process and may result in
tubing welds of inadequate
strength.
• Do not touch the indicated

part with the fingers because
Figure 10
it is hot (See Figure 10).
16
PROCEDURE FOR USE
TROUBLESHOOTING
5.1.4 Starting the Weld cycle
1. Press the “START” button.

After pressing the “START” button, the fan absorbing the smoke will start, and “HEATING
WAFER” will be displayed on the LCD display. When the wafer reaches the setting temperature,
“WELDING” will be displayed and the welding process starts. After a certain time “COOLING” is
displayed, the buzzer sounds, the fan stops and the welding cycle is completed.
CAUTIONS • Do not touch the clamps once the weld cycle has begun, as this
might stop the welding process.
• After pressing the “START” button, the clamps are locked until the
welding cycle is completed. Do not intentionally open the clamps
during welding.
• Do not pull the tubing during welding.
• If “DEFECTIVE WAFER” is displayed after pressing the “START”

button, press the “RESET” button to stop the alarm. Then press the
“RESET” button again to replace the wafer.
2. Open the clamp covers.

When “WELD COMPLETE” is displayed and the buzzer sounds, open the clamp covers and take
the tubing out of both slots.
NOTE • Normally it takes 14 seconds to complete the weld cycle after

pressing the “START” button.
5.1.5 Weld Alignment Inspection
1. To inspect the weld alignment, leave the weld sealed

and rotate the welded tubing 360° and visually inspect
how well the outer diameters of the two tubes are
aligned at the connection (weld).
VIEW A ACCEPTABLE
2. Compare your weld to those illustrated in Figure 11.
Ideally, you should see no misalignment (VIEW A), but
differences in the ACCEPTABLE outer diameters of the
two sections of tubing may produce an apparent
misalignment of the weld. This is acceptable. View B VIEW B UNACCEPTABLE
shows a misaligned weld that may be unacceptable.

Figure 11
Repeated misalignment of welds (VIEW B) could indicate
that service may be necessary.
CAUTION • Misaligned welds may not be complete. Consider that the blood
product has been exposed to air and change the product expiration
accordingly.
17
PROCEDURE FOR USE
5.1.6 Opening the weld
Hold the welded tubing between your fingers with the

flattened side of the weld facing up. Open the seal by
pinching or rolling the tubing until the fluid pathway opens
(See Figure 12).
5.2 Replacing the wafer cassette Figure 12
1. Confirm that the TSCD®-II is not replacing the wafer.

”EJECT” button
2. Press the “EJECT” button (See Figure 13). The far edge of
the cassette will pop up so that it can be seized and
pulled out of the compartment.
3. Position the new cassette so that the label is on top and

facing the operator installing the cassette. Slide the cavity
at the front edge of the cassette onto the metal tab at
the front edge of the compartment. WAFER CASSETTE
Figure 13
4. Push the back edge of the cassette down until it snaps
into place.
5.3 Snap on the blood bag support

1. The Blood Bag support has two tips, one on each end.
Snap the tips carefully into the respective holders on the
TSCD®-II (See Figure 14).
CAUTIONS • DO NOT LIFT THE BAG

SUPPORTS FOR CARRY.
• Do not transport the TSCD®-II

Bag support
with the mounted blood bag
supports. Figure 14
• Place the blood bag softly on

the blood bag support. Do not
drop it onto the blood bag
support.
• Withstand load of each

support is 20 N. For safety
reason, bag support can be
taken off when impact strikes.
18
PROCEDURE FOR USE
TROUBLESHOOTING
2. Pull up the blood bag support to remove it (See Figure 15).
Figure 15
5.4 Detachable cover
1. After opening the cover, it can be detached by pushing it
backwards (See Figure 16). Cover
Figure 16
2. To re-attach the cover, hold it in vertical position and slide

it down into the hinge sockets on the top at the rear side Cover
of the TSCD -II (See Figure 17).

®
Hinge
Figure 17
19
PROCEDURE FOR USE
CAUTION • Do not bring any magnetic

sensitive equipment close to
the parts on the TSCD®-II
where the magnets are
mounted (See Figure 18).
Figure 18
5.5 Wafer disposal

1. Remove the wafer disposal box from the TSCD®-II by
drawing it backwards (See Figure 19).
CAUTIONS • Remove the wafer disposal

box immediately when the
display indicates “DISPOSAL
BOX FULL”. Wafers cannot be
replaced until full wafer
disposal box has been
emptied.
Wafer disposal box
• The wafer disposal box can
Figure 19
be removed any time even if
not full. Check if the TSCD®-II
is not replacing a wafer when
removing a not completely
filled wafer disposal box.
2. Dispose the used wafers by opening and emptying the wafer disposal box.
WARNINGS • Follow proper biohazard handling procedures when disposing the

used wafers. Treat all used wafers as potentially infectious.
• Wafers cannot be reused.
3. Insert wafer disposal box
CAUTIONS • The TSCD®-II has photo sensors on both sides of the wafer
disposal box to detect the filling level of the box. Do not block the
two holes on the wafer disposal box.
• Insert the wafer disposal box correctly into the TSCD®-II. If the
wafer disposal box is incorrectly inserted, wafer jam or incorrect fill
detection may occur.
20
PROCEDURE FOR USE
TROUBLESHOOTING
5.6 Cleaning procedure

The TSCD®-II is designed for minimum care. Always keep the TSCD®-II clean. Surfaces of the
instrument may be cleaned with a damp cloth and a neutral detergent or a disinfectant such as
medical alcohol or an aqueous solution of chlorhexidine gluconate.
1. Turn off the “POWER” switch and unplug the AC power cable from the AC outlet.
2. Clean the surfaces of the instrument with a soft cloth saturated with a neutral detergent or
medical alcohol or an aqueous solution of chlorhexidine gluconate of less than 0.5%.
3. Clean the clamps with a cotton swab saturated with medical alcohol or an aqueous solution of
chlorhexidine gluconate of less than 0.5%.
4. Clean the wafer jam repair holes with a cotton swab saturated with medical alcohol, neutral
detergent or a chlorhexidine gluconate solution of less than 0.5%.
5.7 Replacing the air filter

Periodical replacement of the air filter is recommended and can
be done as follows:
1. Pull out the filter case from the bottom of the TSCD®-II
and take away present filter in the filter case
(See Figure 20).
2. Set new air filter in the filter case. (See Figure 21)
CAUTION • Set the new air filter carefully

and do not bend it or let it
slip out of the filter case. Filter case
Figure 20
3. Insert the filter case in the TSCD®-II.
NOTES • If excessive smoke comes out Filter case

of the TSCD®-II during welding,
replace the air filter.
• It is recommended to
replace the air filter each
2000 welds or after 1 month.
• New air filters and/or more

Craws Air filter
information on filter
replacement is available from Figure 21
Terumo BCT’s personnel.
21
PROCEDURE FOR USE
5.8 Parameter setting mode

When the “S” mark appears on the display, the parameter
setting mode can be selected by pressing the “START” button ADVANCE WAFER
for 2 seconds. Parameters are changed using the “START” and PRESS RESET
“RESET” buttons.
Start SETTING MODE?
5.8.1 Language Start: YES Reset: No
Select language
1. Language
1. Press the “RESET” button and “Language” is indicated on
0. English
the display. The display indicates the current language.
2. Change the language by pressing the “START” button

(English, French, German, Spanish, Italian, Dutch,
Swedish, Danish, Norwegian, Finnish, Portuguese and
Greek are available).
5.8.2 Buzzer volume
Buzzer volume can be selected from 8 levels.
1. Press “RESET” button till “Buzzer Volume” is indicated on

2. Buzzer Volume
the display. Display indicates current volume. [-] >>> [+]
2. Change the volume by pressing the “START” button.
5.8.3 Date format
Select European or American date format.
1. Press “RESET” button till “Date Configuration” is indicated

3. Date Configuration
on the display. The display indicates current date format.
1: MM/DD/YYYY
2. Change the date format by pressing the “START” button.
5.8.4 Information system activation
Select the activation of TOMEs connection.
1. Press “RESET” button till “IS connection” is indicated on

4. IS connection
the display. The display indicates the current status of the
ON
IS (TOMEs) activation.
22
PROCEDURE FOR USE
TROUBLESHOOTING
2. Change the IS (TOMEs) activation status by pressing the

“START” button.
NOTE • When changing parameter of

IS activation, Hardware must
be reset. Turn the power off
after exiting parameter setting
mode and turn the power on
again.
5.8.5 Weld counter
Check or reset the number of welds.
1. Press the “RESET” button till “Counter Reset” is indicated 5. Counter Reset
on the display. The display indicates the current weld 00000019
count.
2. Reset the weld count by pressing “START” button for 2

seconds.
5.8.6 Exit from parameter setting mode
1. Press “RESET” button, then “Exit SETTING MODE?” is Exit SETTING MODE?
shown on the display. Start: YES Reset: No
2. Press “START” button to save all parameters and exit

from Parameter Setting Mode.
23
TROUBLESHOOTING
6 TROUBLESHOOTING
6.1 Prompts on the display
The information in this section was compiled to serve as a reference for the operators during welding
and troubleshooting of the TSCD®-II.
By following the prompts on the LCD the operators will know where in the welding process they are as
well as be able to perform basic troubleshooting routines. If after following the recommended routines
listed below the problem still persist, call Terumo BCT for servicing.
OPERATIONAL PROMPTS
Item Message on
Status Action required
No. display
1 POWER ON Power is turned on. Wait till display change.
2 SYSTEM CHECK The TSCD -II is checked.

®
Wait till display change.
3 HOLDER WARM UP The wafer holder is warming up. Wait till display change.
*****
4 ALIGN CLAMP Clamp is closed and not aligned. Open the clamp and remove the tubes.
OPEN CLAMP
5 ALIGN CLAMP Clamp is not aligned. Press “Reset” button to align the clamp.
PRESS RESET
6 CLAMP ALIGNING Clamp is moving to home Wait till display change.

position.
7 ADVANCING WAFER New Wafer is automatically Wait till display change.

advanced to welding position.
8 DISPOSAL BOX FULL Wafer Disposal Box is full of Discard used Wafers and press “Reset”
DISCARD WAFERS Wafers. button.
9 CASSETTE EMPTY Wafer Cassette is either empty Install new Wafer Cassette.
INSTALL CASSETTE or not installed.
10 PLACE TUBING Clamp is still closed and tubing Open clamp and place tubing.
OPEN CLAMP has to be placed.
11 PLACE TUBING Clamp is open and tubing has to Place tubing and close clamp.
CLOSE CLAMP be placed.
12 WELDING Ready to start welding process. Press “Start” button to start welding
PRESS START process.
13 HEATING WAFER Heating Wafer to welding Wait till display change.

temperature.
14 WELDING Welding process occurs. Wait till display change.
15 COOLING The time allowed for the weld to Wait till display change.
cool down.
16 WELD COMPLETE Weld process is complete. Open Clamp and remove welded tubing
OPEN CLAMP and segments from clamp.
17 OPERATING TEMP The TSCD®-II is unable to Place the TSCD®-II into an environment
OUT OF RANGE stabilize welding temperature that is within the recommended
because it is not within its operating range of 10 - 40°C, 50 - 104°F.
recommended operating range.
18 WAFER JAM Wafer is jammed. See section 6.3

PRESS RESET “Procedure to repair a Wafer jam”
24
TROUBLESHOOTING
TROUBLESHOOTING
Item Message on
Status Action required
No. display
19 DEFECTIVE WAFER 1 Welding with used Wafer. Press “Reset” button once to clear
PRESS RESET error.
Press “Reset” button again to replace
used Wafer.
20 DEFECTIVE WAFER 2 Welding with incorrect Wafer Press “Reset” button once to clear
PRESS RESET not the TSCD® Wafer. error. Install TSCD® Wafer Cassette into
compartment and press “Reset” to
replace SCD Wafer, two times.
21 DEFECTIVE WAFER 3 Wafer is wet during heating to Press “Reset” button once to clear
PRESS RESET welding temperature. error.
wet Wafer.
22 DEFECTIVE WAFER 4 Abnormal current through the Press “Reset” button once to clear
PRESS RESET wafer during heating process. error.
Wafer.
23 DEFECTIVE WAFER 5 Abnormal voltage during Press “Reset” button once to clear
PRESS RESET heating the wafer. error.
Wafer.
24 DEFECTIVE WAFER 6 Wafer initial resistance over Press “Reset” button once to clear
PRESS RESET range. error.
Wafer.
25 DEFECTIVE WAFER 7 Wafer heating power Press “Reset” button once to clear
PRESS RESET continuously high. error.
Wafer.
26 DEFECTIVE WAFER 8 Wafer breaking. Press “Reset” button once to clear

PRESS RESET error.
Wafer.
27 WAFER JAM Wafer is jammed at Clamp See section 6.3

REMOVE WAFER position. “Procedure to repair a Wafer jam”
28 INSTALLATION Recovering from wafer jam. Close the clamps and press “Reset”
CLOSE CLAMP button after taking the wafer away from
clamp portion.
29 ADVANCE WAFER No or used Wafer in welding Press “Reset” button to advance new
PRESS RESET position. Wafer.
30 START RESTORING Turning the power on after shut Press “Reset” button to restart welding.
PRESS RESET down during welding operation.
31 RESTOR COMPLETE Complete recovering from shut Open Clamp and remove welded
OPEN CLAMP down process. tubing and segments from clamp.
32 Retry IS connection? Re-start Communication with Press “Start” to connect to TOMEs

START: yes Reset: TOMEs. Stations.
no Press “Reset” to work offline.
33 IS connection now Re-try to send command. Re-start communication.

connecting
25
TROUBLESHOOTING
RECOVERABLE ERROR
Following errors are recoverable by pressing the “RESET” button. If after following the
recommendations in the table below, the problem still persists, call Terumo BCT for servicing.
Item
Message on display Status Action required
No.
34 SENSOR ERR 0 Technical problem: clamp Press “Reset” to clear. If the problem
PRESS RESET Solenoid still persists, call Terumo BCT for
Sensor is “On”. servicing.
Solenoid still persists, call Terumo BCT for
PRESS RESET
Sensor is “Off”. servicing.
PRESS RESET Solenoid still persists, call Terumo BCT for
servicing.
Sensor is “Off” while the
Clamp Solenoid is “On”.
37 SENSOR ERR 3 Disposal box sensor facing to Press “Reset” to clear. If the problem
PRESS RESET the sun. still persists, call Terumo BCT for
servicing.
38 CAM ERR 0 Technical problem: Cam Press “Reset” to clear. If the problem
PRESS RESET cannot find home position still persists, call Terumo BCT for
when rotation is initialized. servicing.
cannot leave home position still persists, call Terumo BCT for
PRESS RESET
cannot find welding position still persists, call Terumo BCT for
PRESS RESET
PRESS RESET cannot leave welding position still persists, call Terumo BCT for
42 CAM ERR 4 Technical problem: Cam Press “Reset” to clear. If the problem still
PRESS RESET cannot find home position persists, call Terumo BCT for servicing.
when rotation is initialized.
PRESS RESET cannot leave home position persists, call Terumo BCT for servicing.
cannot find welding position persists, call Terumo BCT for servicing.
PRESS RESET
45 CAM ERR 7 Wafer holder cannot reach to Press “Reset” to clear. If the problem still
PRESS RESET the upper limit. persists, call Terumo BCT for servicing.
46 RESET JAM ERR Technical problem: Wafer Press “Reset” to clear. If the problem still
PRESS RESET Shuttle cannot return to persists, call Terumo BCT for servicing.
home position because of
Wafer jam.
47 ENCODER ERR Technical problem: Stepper Press “Reset” to clear. If the problem still
Motor and Encoder are not persists, call Terumo BCT for servicing.
PRESS RESET
synchronized.
48 REPL WF ERR 0 Technical problem: Home Press “Reset” to clear. If the problem still
PRESS RESET Sensor stays activated when persists, call Terumo BCT for servicing.
Wafer Shuttle is in forward
position.
26
TROUBLESHOOTING
TROUBLESHOOTING
Item
No.
49 REPL WF ERR 1 Technical problem: Forward Press “Reset” to clear. If the problem still
Sensor does not activate persists, call Terumo BCT for servicing.
PRESS RESET
when Wafer Shuttle is in
forward position.
50 REPL WF ERR 2 Technical problem: Forward Press “Reset” to clear. If the problem still
PRESS RESET Sensor stays activated when persists, call Terumo BCT for servicing.
Wafer Shuttle is in home
position.
51 REPL WF ERR 3 Technical problem: Home Press “Reset” to clear. If the problem still
PRESS RESET Sensor does not activate persists, call Terumo BCT for servicing.
when Wafer Shuttle is in
home position.
Following errors can only happen if the parameter ’Information System connection’ is activated.
Item
No.
52 COMM ERR 0 Communication problem: Press “Reset” to clear. If the problem still
No Carriage Return. persists, call Terumo BCT for servicing.
PRESS RESET
PRESS RESET No Carriage Command. persists, call Terumo BCT for servicing.
PRESS RESET RX Command Data Length persists, call Terumo BCT for servicing.
Error.
No Comma on RX. persists, call Terumo BCT for servicing.
PRESS RESET
PRESS RESET RX Numeric Code Error. persists, call Terumo BCT for servicing.
Communication Error. persists, call Terumo BCT for servicing.
PRESS RESET
58 COMM ERR 6 On TOMEs Stations, the user Press “Reset” to clear. The connection
PRESS RESET left a process after a Prepare should not be lost and the user can
Weld event was passed but continue using TSCD®-II together with
before its Weld event was TOMEs.
passed. This is not a problem.
Communication problem: Press “Reset” to clear. If the problem still

Communication Error. persists, call Terumo BCT for servicing.
59 COMM ERR 7 Available communication Press “Reset” to clear. If the problem still
receiving AB command. persists, call Terumo BCT for servicing.
PRESS RESET
60 COMM ERR TIME OUT Communication problem. Press “Reset” to clear. Please refer to the
PRESS RESET Instructions for Use of TOMEs.
If there are other kinds of phenomena out of above list, call Terumo BCT for servicing.
27
TROUBLESHOOTING
6.2 Troubleshooting table

The information in this section is compiled so that many common problems can be solved by the
operator. If after following the recommendations in the following table, the problem still persists, call
Terumo BCT for servicing.
Symptom Probable Cause Corrective Action
The display does not light up. 1. Instrument is turned off. 1. Turn the “POWER” switch ON.
2. Instrument is unplugged. 2. Check power cord connection at wall

outlet and back of instrument.
3. The display light is 3. Verify by testing that the left clamp will
broken. align with the right clamp after
completing a weld although the
display light is defective. Continue
using the instrument, but call Terumo
BCT for servicing.
4. Fuses have blown. 4. Replace fuses. If the fuses break

frequently, call Terumo BCT for
servicing.
Continuous beep sounds. Mechanical system is faulty. Call Terumo BCT for servicing.
Excessive smoke is ob- Air filter is blocked. Replace the Air Filter. See Section 5.7
served during the welding “Replacing the Air Filter”.
process.
Solution leakage is observed Tubing being welded is CAUTION: Solution leakage suggests
in the welding part incompatible. that the inside of the tubing
may have been contaminated.
Check size of tubing used. See Section 1.2

“Specifications”.
6.3 Procedure to repair a wafer jam

When the display indicates “WAFER JAM REMOVE WAFER” or
“WAFER JAM PRESS RESET” you have to repair the wafer jam
with the help of the wafer jam repair tool. Do it as follows.
WRONG
CAUTION • Never insert the wafer jam

repair tool into the wafer jam Front
repair holes (both rear and
front holes) towards the rear
direction of the TSCD®-II (see
Figure 22). Doing so could
damage the parts inside the Figure 22
unit causing incomplete
welds.
28
TROUBLESHOOTING
TROUBLESHOOTING
1. Remove the tube, if any, from the slots of the clamps.
2. Insert the wafer jam repair tool through the front wafer
jam repair hole of the TSCD®-II and push the tool straightly
down so that a wafer inside can be dropped into the
wafer disposal box (See Error! Reference source not Front wafer jam
repair hole
found.).
CAUTIONS • For the front wafer jam repair

Figure 23
hole, insert the wafer jam
repair tool vertically.
• For the rear wafer jam repair

repair tool into the slantingly
forward direction.
3. Similarly, insert the wafer jam repair tool through the rear
wafer jam repair hole of the TSCD®-II and push the tool
slantingly forward so that a wafer inside can be dropped
into the wafer disposal box (See Figure 24).
CAUTIONS • A used wafer jam repair tool

is considered as biohazard Rear wafer jam
repair hole
and must be disinfected
using medical alcohol or a
chlorhexidine gluconate
Figure 24
solution of less than 0.5%.
• Keep the wafer jam repair

tool carefully at hand so that
it is always available
• For the front wafer jam repair

repair tool vertically.
• For the rear wafer jam repair

repair tool into the slantingly
forward direction.
• Do not insert any items other

than the wafer jam repair tool
through the wafer jam repair
holes.
29
TROUBLESHOOTING
CAUTIONS • When inserting the wafer jam

repair tool through the wafer
jam repair holes, do not
apply excessive force that
could damage the wafer jam
repair tool and the TSCD®-II.
• In the case of failure in

dropping jammed wafers
into the wafer disposal box,
stop the procedure and call
Terumo BCT for servicing.
4. In the case that the display indicates “WAFER JAM

REMOVE WAFER” push the right clamp to the right to
secure a clearance between the clamps. While pushing
the right clamp to the right, remove the wafer between
the clamps using tweezers or needle nose pliers (See
Figure 25).
CAUTIONS • When removing a wafer,

care must be taken not to Figure 25
damage other parts inside
of the TSCD®-II. It may
cause incomplete welds.
• In the case of the failure to

remove a wafer, stop the
procedure and call Terumo
BCT for servicing.
In the case that the display indicates “WAFER JAM PRESS

RESET” the right clamp cannot be pushed to the right
direction. In this case don’t try to remove the wafer between
the clamps in a forced manner.
5. Visually check that there are not jammed wafers inside

through the wafer jam repair holes.
6. Remove the wafer disposal box and check visually that

there are not jammed wafers inside from the front of
TSCD®-II (See Figure 26). After confirming, return the
wafer disposal box.
Figure 26
30
TROUBLESHOOTING
TROUBLESHOOTING
7. Remove the wafer cassette out of the TSCD®-II. In case

this is not possible, re-insert the wafer cassette. Then,
press the “RESET” button according to the instructions
on the display until the wafer is replaced with a new one.
After the replacement, try to remove the wafer cassette
again.
CAUTION • In the case that a wafer

has been replaced but the
wafer cassette still cannot
be removed, stop the
procedure and call Terumo
BCT for servicing.
8. Visually check whether a wafer still remains in the wafer

cassette holder and confirm that the wafer in the wafer
cassette is not damaged. In the case of a wafer
remaining in the wafer cassette holder, remove it using
tweezers or needle nose pliers (See Figure 27).
CAUTION • In the case of failure to

remove wafer from the
Wafer cassette holder
wafer cassette holder, Figure 27
stop the procedure and
call Terumo BCT for
servicing.
In the case that the wafer cassette taken out from the unit is
found damaged or cracked, don’t use it but replace it with a
cassette without any damages. In the case that the wafer in
the wafer cassette is found deformed or dislocated, don’t
use it but replace it with a cassette without any damages
(See Figure 28).
Wafers are placed correctly
9. Re-insert the wafer cassette.
10. Press the “RESET” and/or “START” button according to

the instructions on the display to continue the welding
process.
Wafers are not placed correctly
CAUTION • In the case of a wafer jam Figure 28
error recurring, discontinue
removal of the jammed
wafer and call Terumo BCT
for servicing.
31
TECHNICAL SUPPORT
7 TECHNICAL SUPPORT
If you experience a system failure, call Terumo BCT 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 on site. Only qualified personnel are authorized to service
the unit and any attempt to repair the TSCD®-II by unqualified personnel will void the warranty and
could increase the cost of the repair.
When sending the unit in for service, please include a completed decontamination certificate.
Technical support - Toll free number from:
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
Other countries call +32 16 39 14 00 at international rates

E-mail: meservice@terumobct.com
32
DISPOSAL (END OF LIFE)
TROUBLESHOOTING
8 DISPOSAL (END OF LIFE)

Electrical and electronic equipment (EEE) and batteries contain materials, components and
substances which can be dangerous to the environment and harmful to human health if waste
electrical and electronic equipment (WEEE) and batteries are not disposed of correctly.
Waste electrical and electronic equipment and batteries must not be disposed of with the remainder of
unseparated waste, but should instead be collected separately. In this way, the environmental impact
associated with disposal of WEEE and batteries is reduced and there will be more opportunity for
reusing, recycling and recovering WEEE and recycling batteries.
At end of life, please dispose of this equipment according to your local regulations. Contact your local
distributor or municipality to know the available collection schemes. The embedded memory back-up
CR2032 battery, collected together with this equipment at end of life as WEEE, is to be removed and
treated by the recycling center.
Terumo Sterile Tubing Welder (TSCD®-II) has a life span of approx. 6 years.
33
EU DECLARATION OF CONFORMITY
9 EU 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 Sterile Tubing Welder (TSCD®-II)
Product Class: The TSCD®-II is classified as active laboratory equipment covered by the
Machinery Directive, 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 Terumo Sterile Tubing Welder (TSCD®-II) catalog number ME-SC203AH,
complies 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 61010-2-010:2014, Safety requirements for electrical equipment for measurement,

control and laboratory use – Part 2-010: Particular requirements for laboratory equipment for
the heating of materials.
EN 61326-1:2013, Electrical equipment for measurement, control and laboratory use - EMC
requirements. General requirements.
34
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36

Terumo Penpol TSCD-II USER MANUAL

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OPERATING INSTRUCTIONS

IMPORTANT SAFETY INFORMATION ................................................................. 4

IMPORTANT SAFETY INFORMATION

NOTE • Highlights essential information.

CAUTION • Includes information regarding any special care to be exercised by the

WARNING • Informs the operator of a hazard or an unsafe practice that could

• The TSCD®-II is an electro-mechanical instrument designed for

• Wafers can be used only once. Wafers cannot be reused. Be sure to

1 FEATURES AND SPECIFICATIONS

• The TSCD®-II has a compact design and is portable.

Product code: ............................................ ME–SC203AH

Tubing material: ......................................... Polyvinyl chloride (PVC)

Tubing sizes: ............................................... Outside diameter: 3.9 - 4.5 mm

Wafer used: ................................................ TSCD® Wafer, model number SC*W017

Operating condition: .................................. Indoor use only

Storage/transport condition:.................... Ambient temperature - 10°C to 50°C (14°F to 122°F)

Pollution degree: ........................................ 2 (according to IEC 664-1)

Overvoltage category Category II

Power supply: ............................................ AC 100V±10% to AC 240V±10% 50/60 Hz, 3.0 A

Noise level: .................................................. < 65 dBA

External dimension: ................................... W224 x H177 x D342 mm

Weight: ........................................................ Approx. 6.5 kg (14.33 lbs)

Accessories with TSCD -II: ......................

Product code Serial number

Stacking limit by 3 This way up

Handle with care Keep dry

Attention, see instructions for use EC representative

Temperature limitation Relative humidity limitation

Keep away from heat and sunlight Manufacturer

Separate collection for electrical and electronic equipment (European symbol)

• Wafer jam repair holes

2.3 Rear of TSCD®-II

WARNINGS • To avoid electric shock, protective grounding conductor in the power

• Do not remove covers. Refer servicing to qualified personnel only.

• Disconnect input power before replacing fuse.

2.4 Control panel

• ”ALARM” indicator lamp

• Wafer cassette compartment

2.6 Optional Accessories

4 GENERAL WARNINGS AND CAUTIONS

WARNINGS • Never use the system on tubing that is connected to a patient.

• Visually check each connection. If a leak is detected, consider the unit

• Do not use the TSCD®-II near a high frequency power source.

• Used wafers are considered as biohazard, dispose of them properly

• A system failure can occur if any foreign matter (solid or liquid)

• The TSCD®-II is an electro-mechanical instrument designed for

• A used wafer jam repair tool is considered as biohazard and must be

• Long term exposure to ultra-violet radiation may cause the external

4.3 Cleaning procedure

• When cleaning the TSCD®-II, be careful not to spill any cleaning

• Professional cleaning and service is required if any liquid (blood,

4.4 Periodical maintenance

• If the TSCD®-II is dropped, service is recommended even if there is

• For servicing, please call Terumo BCT.

5 PROCEDURE FOR USE

5.1 Operational flow chart

2. Align clamps (push “RESET” button)

3. Place tubing in clamps

4. Close both clamps simultaneously

5. Start connection (push “START” button)