GE Hot Lips Tube Sealer User manual

HOT LIPS TUBE SEALER Operator Manual 87-4500-07 AI 3
Contents
1 Introduction .................................................................................5
1.1 Important user information ..........................................................................5
1.2 Regulatory information ..................................................................................7
1.3 Safety precautions ...........................................................................................9
1.4 HOT LIPS TUBE SEALER ................................................................................11
1.5 Features ..............................................................................................................12
1.6 Disclaimer ..........................................................................................................13
2 Principles of operation.............................................................15
3 Operation ...................................................................................17
3.1 Controls ...............................................................................................................17
3.2 Operating procedure ....................................................................................18
3.3 Setting the tubing type and size .............................................................19
3.4 How to load the tubing ................................................................................20
3.4.1 Proper loading of tube......................................................................................22
3.4.2 Improper loading of tube.................................................................................22
3.4.3 Inspecting seal quality......................................................................................23
3.4.4 How to handle filled tubing ............................................................................24
3.4.5 Cutting sealed tubing........................................................................................25
3.4.6 Checking the version number........................................................................26
3.4.7 Setting tube diameter units............................................................................26
4 Troubleshooting........................................................................27
4.1 Operation steps ...............................................................................................27
4.2 General troubleshooting .............................................................................28
5 Specifications.............................................................................29
5.1 Technical specifications ..............................................................................29
5.2 Tubing ..................................................................................................................30
Appendix A Compatible tubing ....................................................31
Appendix B Ordering information ...............................................33

4HOT LIPS TUBE SEALER Operator Manual 87-4500-07 AI

HOT LIPS TUBE SEALER Operator Manual 87-4500-07 AI 5
Introduction 1
Important user information 1.1
1 Introduction
1.1 Important user information
Read this before using HOT LIPS
TUBE SEALER
All users must read the entire STERILE TUBE FUSER - DRY and HOT LIPS TUBE
SEALER Operating Instructions before installing, using or maintaining the
instrument. Always keep the Operating Instructions at hand when using HOT LIPS
TUBE SEALER.
Do not operate HOT LIPS TUBE SEALER in any other way than described in the user
documentation. If you do, you may be exposed to hazards that can lead to personal
injury and you may cause damage to the equipment.
Intended use
HOT LIPS TUBE SEALER is an automated instrument designed to seal thermoplastic
tubing. HOT LIPS TUBE SEALER shall not be used in any clinical procedures, or for
diagnostic purposes.
Safety notices
This user documentation contains WARNINGS, CAUTIONS and NOTICES concerning
the safe use of the product. See definitions below.

1 Introduction
1.1 Important user information
6HOT LIPS TUBE SEALER Operator Manual 87-4500-07 AI
Warnings
Cautions
Notices
Notes and tips
Note: A Note is used to indicate information that is important for trouble-free and
optimal use of the product.
Tip: A tip contains useful information that can improve or optimize your
procedures.
Typographical conventions
Software items are identified in the text by bold italic text. A colon separates menu
levels, thus File:Open refers to the Open command in the File menu. Hardware
items are identified in the text by bold text (e.g., Power switch).
WARNING
WARNING indicates a hazardous situation which, if not avoided, could result
in death or serious injury. It is important not to proceed until all stated
conditions are met and clearly understood.
CAUTION
CAUTION indicates a hazardous situation which, if not avoided, could result
in minor or moderate injury. It is important not to proceed until all stated
conditions are met and clearly understood.
NOTICE
NOTICE indicates instructions that must be followed to avoid damage to the
product or other equipment.

HOT LIPS TUBE SEALER Operator Manual 87-4500-07 AI 7
Introduction 1
Regulatory information 1.2
1.2 Regulatory information
This section lists the directives and standards that are fulfilled by HOT LIPS TUBE
SEALER.
Manufacturing information
The table below summarizes the required manufacturing information. For further
information, see the EC Declaration of Conformity document.
International standards
Requirement Content
Name and address of
manufacturer
GE Healthcare Bio-Sciences AB,
Björkgatan 30,
SE 751 84 Uppsala,
Sweden
Name and ID of notified body INTERTEK SEMKO AB, NB 0413
Standard Description Notes
EN 61010-1,
IEC 61010-1,
UL 61010-1,
CAN/CSA-C22.2 no.
61010-1
Safety requirements for
electrical equipment for
measurement, control and
laboratory use
EN harmonized with
2006/95/EC
EN 61326-1 EMC emissions and
immunity requirements for
measurement, control and
laboratory use
Harmonized with
2004/108/EC
EN ISO 12100:2010 Safety of machinery. General
principles for design. Risk
assessment and risk
reduction.
Harmonized with
2006/42/EC

1 Introduction
1.2 Regulatory information
8HOT LIPS TUBE SEALER Operator Manual 87-4500-07 AI
CE conformity
CE marking
The CE marking and the corresponding Declaration of Conformity is valid for the
instrument when it is:
• used as a stand-alone unit, or
• connected to other CE-marked instruments, or
• connected to other products recommended or described in the user
documentation, and
• used in the same state as it was delivered from GE Healthcare, except for
alterations described in the user documentation or explicitly authorized by
GE Healthcare.
Regulatory compliance of
connected equipment
Any equipment connected to HOT LIPS TUBE SEALER should meet the safety
requirements of EN 61010-1/IEC61010-1 or relevant harmonized standards. Within
the European Union, connected equipment must be CE-marked.
Directive Title
2006/42/EC Machinery Directive (MD)
2006/95/EC Low Voltage Directive (LVD)
2004/108/EC ElectroMagnetic Compatibility
(EMC) Directive

HOT LIPS TUBE SEALER Operator Manual 87-4500-07 AI 9
Introduction 1
Safety precautions 1.3
Recycling
1.3 Safety precautions
All users must read this section and the Safety instructions chapter in STERILE
TUBE FUSER - DRY and HOT LIPS TUBE SEALER Operating Instructions before
using HOT LIPS TUBE SEALER, and observe the safety information at all times
during use.
This symbol indicates that the waste of electrical and electronic
equipment must not be disposed as unsorted municipal waste
and must be collected separately. Please contact an authorized
representative of the manufacturer for information concerning
the decommissioning of equipment.
WARNING
The end user must ensure that all installation, maintenance,
operation and inspection is carried out by qualified personnel who
are adequately trained, understand and adhere to local regulations
and the operating instructions, and have a thorough knowledge of
the entire system and process.
WARNING
Hot surfaces of HOT LIPS TUBE SEALER. The jaws reach over 200°C
during the heating cycle. Do not touch the jaws during operation.
WARNING
Pinch hazard when using HOT LIPS TUBE SEALER. The jaws are moving
during clamping and calibration. Keep away from the jaws when
clamping tubes and during the calibration procedure.
WARNING
Before starting HOT LIPS TUBE SEALER please make sure that no objects/
tubes are kept in between the heating jaws or moving path.

1 Introduction
1.3 Safety precautions
10 HOT LIPS TUBE SEALER Operator Manual 87-4500-07 AI
WARNING
Disconnect power. Always disconnect power from the instrument before
performing any maintenance task.
WARNING
Depending on which tubes that are used, hazardous gases may emit.
Make sure to use the instrument in a room with proper ventilation.
WARNING
Always use appropriate personal protective equipment during operation
and maintenance of HOT LIPS TUBE SEALER.
CAUTION
Only use tubing that is compatible with the instruments. Refer to
Appendix A for a list of tubing types that have been tested.
CAUTION
Do not spill liquid into HOT LIPS TUBE SEALER. This can cause serious
damage and will void the warranty.
NOTICE
This is a class A product, input power > 1 kW, intended for professional
use. In a domestic environment it may cause radio interference, in which
case the user might be required to take appropriate measures.
NOTICE
Leave space around the unit for proper ventilation.

HOT LIPS TUBE SEALER Operator Manual 87-4500-07 AI 11
Introduction 1
HOT LIPS TUBE SEALER 1.4
1.4 HOT LIPS TUBE SEALER
Introduction
The HOT LIPS TUBE SEALER is a fully automated unit designed to seal thermoplastic
tubing. The machine is useful for sealing feed, harvest and sample tubing
connected to bags or other containers, for storage and transportation. The unit is
designed to seal a wide range of tubing diameters. See Appendix A for all approved
tubing. Major uses are in bioprocessing and in aseptic applications.
Main parts
The illustration below shows the main parts of HOT LIPS TUBE SEALER.
.
NOTICE
High pressures can be generated if the liquid in the seal area has no
place to go when it is clamped down by the sealing jaws. Make sure that
the liquid can be displaced up or downstream of the seal and ensure that
the temporary clamps or plugs are secure.
Part Description
1Movingjaw
2 LCD display
3GO button
4LIFT UP TO LOAD TUBE handle (tube loading handle)
2
1
3
4

1 Introduction
1.5 Features
12 HOT LIPS TUBE SEALER Operator Manual 87-4500-07 AI
Rear panel
The illustration below shows the rear panel of HOT LIPS TUBE SEALER.
1.5 Features
• True thermal seal provides tamperproof protection
• 100-120/220-240 V~ (autoswitching)
• Compact, portable
• No compressed air or cooling water needed
• Automated, validatable, 2 to 3 minutes sealing cycle
HOT LIPS TUBE SEALER is a portable unit for heat sealing thermoplastic tubing. The
leakproof and tamper proof seal is ideal for ensuring that inoculum, products,
media or buffers do not leak through tubing clamps, hemostats, or plugs suitable
for shipment, storage and cGMP operations.
Features include keypad selectable programs for virtually all types and sizes of
thermoplastic tubing. No adaptors or accessories are required over the entire size
Part Description
1 Power switch
2 Fuse holder
3 Power connector
4Keylock
5 Data jack
1
2
3
45

HOT LIPS TUBE SEALER Operator Manual 87-4500-07 AI 13
Introduction 1
Disclaimer 1.6
range. The portable lightweight unit has a carrying handle and can be plugged into
any 100-120/220-240 V~ power outlet making it usable anywhere in the plant or
laboratory. No compressed air or cooling water is required.
1.6 Disclaimer
The HOT LIPS TUBE SEALER has been tested to produce seals of sufficient quality
and strength. It is believed to be adequate for the intended application. Under no
circumstances can data in this manual be submitted to any regulatory agency in
support of a clinical product, without specific written permission from the
manufacturer.
The manufacturer is not liable for any loss incurred due to the use of this
equipment.
It is the responsibility of the end user to verify and validate the suitability of this
device for a specific application. Seals should be carefully inspected before use.

1 Introduction
1.6 Disclaimer
14 HOT LIPS TUBE SEALER Operator Manual 87-4500-07 AI

HOT LIPS TUBE SEALER Operator Manual 87-4500-07 AI 15
Principles of operation 2
2 Principles of operation
Introduction
The HOT LIPS TUBE SEALER is used to seal tubing permanently. This is done by
clamping the tubing to be sealed in a precise position between two heated jaws.
The molten tubing is pressed together and cooled under high pressure resulting in
a permanent, leak-proof, butt seal.
Compatible tubing
Only thermoplastic tubes listed in Appendix A can be used for the sealing operation.
See Appendix A for all approved tubing types. It is not possible to seal materials
such as PTFE or silicone as these materials are not thermoplastic.
Sealing method
The HOT LIPS TUBE SEALER can handle various size tubing diameters specified in
Appendix A without the need for any additional holders or adaptors. The machine
squeezes the tubing to be sealed to a precise thickness based on the material of
the tubing and its diameter. The tubing is then melted by heat and cooled under
pressure to form a seal. This unique “mold-free” process permits different sizes and
materials to be sealed without requiring specific dyes. The low thermal mass of the
heated jaws can be readily air-cooled in a matter of minutes eliminating the need
for cooling water or refrigeration.
Safety function
The jaws of the HOT LIPS TUBE SEALER can exert several tons of pressure. During
the clamping operation, the GO button must be pressed and held down until the
jaws have closed completely (indicated by a beep). If the button is released
prematurely, the jaws will immediately go to the full open position. Furthermore,
the jaws will not heat until they are in closed position. In the closed position, it is not
possible to bring anything into contact with the heated jaws.

2 Principles of operation
16 HOT LIPS TUBE SEALER Operator Manual 87-4500-07 AI

HOT LIPS TUBE SEALER Operator Manual 87-4500-07 AI 17
Operation 3
Controls 3.1
3Operation
3.1 Controls
The main power switch is located at the rear of the unit. The operating controls are
located on the front panel of the unit. Functions are accessed using the front
keypad:
Part Description
1 LCD display
2MENU button
Press the Enter button to go to Tubing Selection
Menu. Press MENU button to abort selection and
return to normal display.
3 Cursor up button
Moves up through the selection list.
4 Cursor down button
Moves down through the selection list
5 Enter button
Enter function. Accepts new selection
6READY indicator
7GO button
Advances to next step in the sealing process. Only
active when READY light is lit.
Ready
ME N U
GO
READYREADY
1
32 7
6
54

3 Operation
3.2 Operating procedure
18 HOT LIPS TUBE SEALER Operator Manual 87-4500-07 AI
3.2 Operating procedure
Step User action Response LCD display
1Switch power on. The LCD will show “INITIALIZING” and
sealing jaws will move to the load
position.
2Check that the tubing type
and diameter displayed are
correct. If not, then set to
match the tubing to be
sealed (Steps 2A to C).
When the diagnostic checks are
complete, the unit will prompt you to
insert the tubing and will display the
current tubing setting. The READY light
will come on.
3Lift the tube loading handle
upwards. The red safety
flag will turn to allow you to
insert the tubing. Place the
tubing in between the jaws
resting on the stainless
steel platform. Release the
tube loading handle and
verify that the red safety
flag is on top of the tubing.
Press and hold the GO
button down until a beep is
heard. The GO button may
be released at that point.
The jaws will close to squeeze the
tubing. The READY light will go out.
Once the jaws are closed, the sealing
will begin. The LCD screen will display
progress of the cycle and the time in
seconds for each step.
If the GO button is released before the
jaws have closed to the preset sealing
position, the step will be aborted and
the jaws will open again to the load
position (Step 2).
4Wait for the sealer jaws to
open and release the sealed
tubing. Remove the tubing
and reset the machine for
the next cycle by pressing
the GO button.
Inspect the seal carefully
before use. Allow a few
minutes for the seal to cool
completely to anneal to
maximum strength.
The machine will open to the release
position. The sealing jaws will be cool to
touch. The seal cycle is complete. The
READY light will come on.
Each seal cycle takes about 2 to 3
minutes depending on the tubing type
and diameter.
INITIALIZING
INSERT TUBING
CFLEX 3/8 × 5/8
PLEASE WAIT
Press GO to START
CLOSING
HOLD BUTTON DOWN
HEATING
TEMP = xxx °C
SOAKING
TIME TO GO ......XX s
COOLING ......
TEMP = XXX °C
SEALING......
......................XX s
WAITING ....
RELEASE IN ....XX s
OPENING....
SEAL COMPLETE
REMOVE TUBING
CFLEX 3/8 × 5/8
Press GO to reset

HOT LIPS TUBE SEALER Operator Manual 87-4500-07 AI 19
Operation 3
Setting the tubing type and size 3.3
3.3 Setting the tubing type and size
Step User action Response LCD display
2A Press the MENU button. The LCD will show “SELECT TUBING” with
the current setting displayed.
2B Press the cursor up button
or cursor down button
cursor keys until the
desired tubing type and
diameter are displayed.
The LCD will scroll through all the
available tubing combinations.
2C Press the Enter ( ) button
to select this tubing.
Press the MENU button to
abort the selection and
retain the original setting.
The parameters for the selected tubing
are loaded. A beep will confirm load
complete.
This setting will be retained even when
power is turned off.
SELECT TUBING
CFLEX 3/8 × 5/8
SELECT TUBING
PVC 1/2 × 3/4
Press to
select
INSERT TUBING
PVC 1/2 × 3/4

3 Operation
3.4 How to load the tubing
20 HOT LIPS TUBE SEALER Operator Manual 87-4500-07 AI
3.4 How to load the tubing
Precautions
WARNING
Hot surfaces of HOT LIPS TUBE SEALER. The jaws reach over 200°C
during the heating cycle. Do not touch the jaws during operation.
WARNING
Pinch hazard when using HOT LIPS TUBE SEALER. The jaws are moving
during clamping and calibration. Keep away from the jaws when
clamping tubes and during the calibration procedure.
WARNING
Depending on which tubes that are used, hazardous gases may emit.
Make sure to use the instrument in a room with proper ventilation.
WARNING
Before starting HOT LIPS TUBE SEALER please make sure that no
objects/tubes are kept in between the heating jaws or moving path.
NOTICE
Leave space around the unit for proper ventilation.

HOT LIPS TUBE SEALER Operator Manual 87-4500-07 AI 21
Operation 3
How to load the tubing 3.4
Instructions
1Pull up the tube loading handle. This will cause the red safety flag to move up
and swing out of the way.
2Place the tubing in between the sealer jaws on the stainless steel platform. All
clamps, plugs and so on must be outside the stainless steel platform
3Release the tube loading handle. The red safety flag should rest on top of the
tubing.
4Press and hold down the GO button. The jaws should start to close. Hold the
GO button down until the jaws have closed completely (indicated by a beep). If
the GO button is released prematurely, the jaws will open immediately and you
must start again from step 2.
Moving jaw
Tubing to be sealed
Silicone rubber
retention pads
Seal position (on top of
tubing)
Load (Swung out)
position
Pull up tube loading
position.
safety flag to the load
handle to move red

3 Operation
3.4 How to load the tubing
22 HOT LIPS TUBE SEALER Operator Manual 87-4500-07 AI
3.4.1 Proper loading of tube
Lay the tubing so it rests on the stainless steel platform.
3.4.2 Improper loading of tube
Red safety flag should be on top of tube
Tube loading handle
should be
down
Red safety flag below tube