cytiva Sterile Tube Fuser User manual

Sterile Tube Fuser - Dry and Hot
Lips Tube Sealer
Operating Instructions
Original instructions
cytiva.com

Table of Contents
1 Introduction ........................................................................................................ 4
1.1 About this manual ......................................................................................................................................... 5
1.2 Important user information ....................................................................................................................... 6
1.3 Associated documentation ....................................................................................................................... 8
2 Safety instructions ............................................................................................. 9
2.1 Safety precautions ........................................................................................................................................ 10
2.2 Labels ................................................................................................................................................................. 19
2.3 Emergency procedures ............................................................................................................................... 24
2.4 Danger zone ..................................................................................................................................................... 27
3 Instrument description ...................................................................................... 29
3.1 Instrument description of Sterile Tube Fuser - Dry .......................................................................... 30
3.2 Instrument description of Hot Lips Tube Sealer ............................................................................... 32
4 Installation .......................................................................................................... 34
4.1 Site requirements .......................................................................................................................................... 35
4.2 Transport .......................................................................................................................................................... 37
4.3 Unpacking ......................................................................................................................................................... 38
4.4 Electrical connections ................................................................................................................................. 39
4.5 Connecting the printer to Sterile Tube Fuser - Dry (optional) ...................................................... 40
5 Operation ............................................................................................................ 41
5.1 Cover lock for Sterile Tube Fuser - Dry .................................................................................................. 42
5.2 Sterile Tube Fuser - Dry .............................................................................................................................. 43
5.2.1 Operational overview .................................................................................................................................. 44
5.2.2 Fusing tubes ................................................................................................................................................... 46
5.2.3 Inspecting weld quality .............................................................................................................................. 53
5.3 Hot Lips Tube Sealer .................................................................................................................................... 54
5.4 Updating the Tubing Database ................................................................................................................. 61
6 Maintenance ....................................................................................................... 62
6.1 Cleaning before planned service ............................................................................................................. 63
6.2 Cleaning the instrument ............................................................................................................................. 64
6.2.1 Cleaning of Sterile Tube Fuser - Dry .................................................................................................... 65
6.2.2 Cleaning of Hot Lips Tube Sealer .......................................................................................................... 68
6.3 Regular maintenance of Sterile Tube Fuser - Dry .............................................................................. 69
6.4 Maintenance of Hot Lips Tube Sealer ................................................................................................... 70
6.4.1 Tube Restrictor replacement .................................................................................................................. 71
6.4.2 Functional validation and calibration .................................................................................................. 75
6.5 Replacement of fuses ................................................................................................................................... 82
6.6 Storage .............................................................................................................................................................. 84
7 Troubleshooting ................................................................................................. 85
7.1 Sterile Tube Fuser - Dry .............................................................................................................................. 86
7.2 Hot Lips Tube Sealer .................................................................................................................................... 91
Table of Contents
2 Sterile Tube Fuser - Dry and Hot Lips Tube Sealer Operating Instructions 28964139 AG

8 Reference information ....................................................................................... 93
8.1 Specifications .................................................................................................................................................. 94
8.2 Compatible tubing for Sterile Tube Fuser - Dry ................................................................................. 95
8.3 Compatible tubing for Hot Lips Tube Sealer ....................................................................................... 97
8.4 Blade contact materials for Sterile Tube Fuser - Dry ....................................................................... 99
8.5 Ordering information ................................................................................................................................... 100
8.6 Recycling information .................................................................................................................................. 101
8.7 Regulatory information ............................................................................................................................... 102
8.7.1 Contact information .................................................................................................................................... 103
8.7.2 European Union and European Economic Area .............................................................................. 104
8.7.3 Eurasian Economic Union
Евразийский экономический союз .................................................................................................. 105
8.7.4 Regulations for North America ............................................................................................................... 107
8.7.5 Regulatory statements .............................................................................................................................. 108
8.7.6 Other regulations and standards .......................................................................................................... 109
8.7.7 Declaration of Hazardous Substances (DoHS) ................................................................................ 110
8.8 Health and Safety Declaration Form ...................................................................................................... 112
Index ........................................................................................................................... 114
Table of Contents
Sterile Tube Fuser - Dry and Hot Lips Tube Sealer Operating Instructions 28964139 AG 3

1 Introduction
About this chapter
This chapter contains important user information, descriptions of safety notices, regu-
latory information, intended use of the Sterile Tube Fuser - Dry and Hot Lips Tube
Sealer™ instruments, and lists of associated documentation.
In this chapter
Section See page
1.1 About this manual 5
1.2 Important user information 6
1.3 Associated documentation 8
1 Introduction
4 Sterile Tube Fuser - Dry and Hot Lips Tube Sealer Operating Instructions 28964139 AG

1.1 About this manual
Purpose of this manual
The Operating Instructions provide you with the information needed to install, operate
and maintain the product in a safe way.
Typographical conventions
Software items are identified in the text by bold italic text.
Hardware items are identified in the text by bold text.
In electronic format, references in italics are clickable hyperlinks.
Illustrations
The images and annotations in this document are for illustrative purposes only. The
configuration of individual products may vary, and therefore illustrations may not
reflect the actual system delivered.
1 Introduction
1.1 About this manual
Sterile Tube Fuser - Dry and Hot Lips Tube Sealer Operating Instructions 28964139 AG 5

1.2 Important user information
Read this before operating the
product
All users must read the entire Operating Instructions before installing, oper-
ating or maintaining the product.
Always keep the Operating Instructions at hand when operating the product.
Do not operate the product in any other way than described in the user documenta-
tion. 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 of the product
Sterile Tube Fuser - Dry is an automated instrument designed to produce sterile joints
of thermoplastic tubings. Hot Lips Tube Sealer is an automated instrument designed
to seal thermoplastic tubing.
Sterile Tube Fuser - Dry and Hot Lips Tube Sealer shall not be used in any clinical proce-
dures, or for diagnostic purposes.
Prerequisites
In order to operate Sterile Tube Fuser - Dry and Hot Lips Tube Sealer in the way it is
intended:
•The user must be acquainted with the use of general laboratory equipment and with
handling of biological materials.
•The user must read and understand the Safety instructions chapter in the Operating
Instructions.
•The instrument must be installed according to the instructions in the Installation
chapter of the Operating Instructions.
•The user must read Operator Manual (87450021) and Operator Manual (87450007).
Definitions
This user documentation contains safety notices (WARNING, CAUTION, and NOTICE)
concerning the safe use of the product. See definitions below.
1 Introduction
1.2 Important user information
6 Sterile Tube Fuser - Dry and Hot Lips Tube Sealer Operating Instructions 28964139 AG

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.
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 proce-
dures.
1 Introduction
1.2 Important user information
Sterile Tube Fuser - Dry and Hot Lips Tube Sealer Operating Instructions 28964139 AG 7

1.3 Associated documentation
Introduction
This section describes the documentation delivered with Sterile Tube Fuser - Dry and
Hot Lips Tube Sealer.
Supplied documentation
In addition to the Operating Instructions, the Sterile Tube Fuser - Dry and Hot Lips Tube
Sealer instruments are supplied with the respective Operator Manual:
Document Contents
Sterile Tube Fuser - Dry Operator
Manual (supplied with Sterile Tube
Fuser - Dry)
How to use the system, including
concepts, methodology, operation and
troubleshooting.
These documents are also available as
online help.
Hot Lips Tube Sealer Operator Manual
(supplied with Hot Lips Tube Sealer)
Related documentation
Sterile Tube Fuser - Dry and Hot Lips Tube Sealer Tube Data Management Tool User
Manual is supplied with an installation kit (available upon request).
The installation kit enables the user to:
•extend the Sterile Tube Fuser - Dry or Hot Lips Tube Sealer instrument to support
different tubing types.
•manage the factory loaded tubing types.
For more information, see Section 8.2 Compatible tubing for Sterile Tube Fuser - Dry, on
page 95 and Section 8.3 Compatible tubing for Hot Lips Tube Sealer, on page 97.
For ordering information, see Section 8.5 Ordering information, on page 100.
1 Introduction
1.3 Associated documentation
8 Sterile Tube Fuser - Dry and Hot Lips Tube Sealer Operating Instructions 28964139 AG

2 Safety instructions
About this chapter
This chapter describes safety precautions, labels and symbols that are attached to the
equipment. In addition, the chapter describes emergency and recovery procedures,
and provides recycling information.
Important
WARNING
Before installing, operating or maintaining the product, all
users must read and understand the entire contents of this
chapter to become aware of the hazards involved.
In this chapter
Section See page
2.1 Safety precautions 10
2.2 Labels 19
2.3 Emergency procedures 24
2.4 Danger zone 27
2 Safety instructions
Sterile Tube Fuser - Dry and Hot Lips Tube Sealer Operating Instructions 28964139 AG 9

2.1 Safety precautions
Introduction
Sterile Tube Fuser - Dry and Hot Lips Tube Sealer are powered by mains voltage and
handle materials that can be hazardous. Before installing, operating or maintaining the
system, you must be aware of the hazards described in this manual.
Follow the instructions to avoid injury to the operator or other personnel,
damage to samples or other substances handled by the equipment, to the
product, or to other equipment in the area.
The safety precautions in this section are grouped into the following categories:
•General precautions
•Personal protection
•Flammable liquids and explosive environment
•Installing and moving the instruments
•Operation
•Maintenance
General precautions
Sterile Tube Fuser - Dry and Hot Lips Tube Sealer
WARNING
Risk assessment. Perform a risk assessment for any risks due to
the process or process environment. Evaluate the effects the use of
the product and the operational processes may have on the classi-
fication of the hazardous area. The process might cause the area to
increase or the zone classification to change. Implement the risk
reduction measures needed, including use of personal protective
equipment.
WARNING
The customer must make sure 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 product and the entire process.
2 Safety instructions
2.1 Safety precautions
10 Sterile Tube Fuser - Dry and Hot Lips Tube Sealer Operating Instructions 28964139 AG

WARNING
Do not operate the product in any other way than described in the
user documentation.
WARNING
Only properly trained personnel may operate and maintain the
product.
WARNING
Do not attempt to touch the instrument in the power ON condition,
if large amount of liquid spillage (approx. > 50 mL) is found inside
the instrument. Switch off the instrument, disconnect the power
cord and contact Service.
WARNING
Use only approved parts. Only spare parts and accessories that
are approved or supplied by Cytiva may be used for maintaining or
servicing the product.
WARNING
Use appropriate personal protective equipment to prevent inhala-
tion of toxic fumes when heating and treating thermoplastics.
Make sure that the work area is adequately ventilated according to
local regulations.
NOTICE
Sterile Tube Fuser - Dry and Hot Lips Tube Sealer are class A prod-
ucts 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.
Sterile Tube Fuser - Dry
2 Safety instructions
2.1 Safety precautions
Sterile Tube Fuser - Dry and Hot Lips Tube Sealer Operating Instructions 28964139 AG 11

CAUTION
Do not attempt to connect liquid filled tubing using Sterile Tube
Fuser - Dry. This will void the warranty.
Personal protection
Sterile Tube Fuser - Dry and Hot Lips Tube Sealer
WARNING
Always use appropriate Personal Protective Equipment (PPE)
during operation and maintenance of this product.
WARNING
Hazardous substances and biological agents. When using
hazardous chemical and biological agents, take all suitable protec-
tive measures, such as wearing protective clothing, glasses and
gloves resistant to the substances used. Follow local and/or
national regulations for safe operation and maintenance of this
product.
WARNING
Spread of biological agents. The operator must take all neces-
sary actions to avoid spreading hazardous biological agents. The
facility must comply with the national code of practice for
biosafety.
Flammable liquids and explosive
environment
Sterile Tube Fuser - Dry and Hot Lips Tube Sealer
WARNING
Sterile Tube Fuser - Dry and Hot Lips Tube Sealer are not designed
to fuse and seal tubing containing flammable fluids. Sterile Tube
Fuser - Dry and Hot Lips Tube Sealer are not approved for work in a
potentially explosive atmosphere.
2 Safety instructions
2.1 Safety precautions
12 Sterile Tube Fuser - Dry and Hot Lips Tube Sealer Operating Instructions 28964139 AG

Installing and moving the
instruments
Sterile Tube Fuser - Dry and Hot Lips Tube Sealer
WARNING
Power cord. Only use power cords with approved plugs delivered
or approved by Cytiva.
WARNING
Protective ground. The product must always be connected to a
grounded power outlet.
WARNING
Access to power switch and power cord with plug. Do not
block access to the power switch and power cord. The power switch
must always be easy to access. The power cord with plug must
always be easy to disconnect.
CAUTION
Disconnect all tubing, hoses and external cables before moving the
unit.
CAUTION
The product and Hot Lips Tube Sealer have fragile items. Make sure
that the product and Hot Lips Tube Sealer are always in upright
position during transport, movement and storage. Also make sure
no weight is kept on the instrument or instrument packaging.
Sterile Tube Fuser - Dry
WARNING
Use lifting handles located on either side of the instrument to lift
Sterile Tube Fuser - Dry. Use personal protective equipment to
avoid any kind of personal injury.
2 Safety instructions
2.1 Safety precautions
Sterile Tube Fuser - Dry and Hot Lips Tube Sealer Operating Instructions 28964139 AG 13

Operation
Sterile Tube Fuser - Dry and Hot Lips Tube Sealer
WARNING
Do not drop objects into the unit. If an object has been dropped into
the unit, disconnect the power supply before lifting the object out
of the unit.
WARNING
The instrument must never be used if any safety functions are out
of order. Contact your Cytiva service operator for more informa-
tion.
WARNING
Inspect all connections and tubing before start and replace any
defective parts.
CAUTION
Make sure that all tubing, hoses and cables are placed so that the
risk of tripping accidents is minimized.
CAUTION
Remove any spillage on the floor immediately to minimize the risk
for slipping accidents.
CAUTION
Leave space around the unit for proper ventilation.
CAUTION
Use only tubing that is compatible with the instruments.
2 Safety instructions
2.1 Safety precautions
14 Sterile Tube Fuser - Dry and Hot Lips Tube Sealer Operating Instructions 28964139 AG

CAUTION
Depending on which tubes that are used in Sterile Tube Fuser - Dry
or Hot Lips Tube Sealer, hazardous gases may be emitted. Make
sure to use the instrument in a room with proper ventilation.
NOTICE
Improper use of tube data may cause damage to the unit and is not
covered under the warranty.
For a list of tubing types that have been tested for
•Sterile Tube Fuser - Dry refer to Section 8.2 Compatible tubing for Sterile Tube
Fuser - Dry, on page 95
•Hot Lips Tube Sealer refer to Section 8.3 Compatible tubing for Hot Lips Tube Sealer,
on page 97
Sterile Tube Fuser - Dry
WARNING
In setup mode of Sterile Tube Fuser - Dry, with the Programming
lock key horizontal, the instrument can be run with cover open. The
blade poses a burn hazard and movable parts poses a pinch hazard
if the weld process is started in this mode. Use caution when in
setup mode and keep clear of the blade, blade assembly & movable
parts.
WARNING
Hot surfaces of Sterile Tube Fuser - Dry. The cutting blade
reaches 400°C during the heating cycle. Do not try to open the
protective cover during the welding.
WARNING
Pinch hazard when using Sterile Tube Fuser - Dry. There are
movable parts under the protective cover. Do not try to open the
protective cover during the welding.
2 Safety instructions
2.1 Safety precautions
Sterile Tube Fuser - Dry and Hot Lips Tube Sealer Operating Instructions 28964139 AG 15

WARNING
Do not touch the blade of Sterile Tube Fuser - Dry until it cools
down. Always allow the blade to cool down for 30 seconds before
accessing the blade.
WARNING
In case of power failure and instrument reset, Sterile Tube Fuser -
Dry unlocks the cover lock. Do not touch the blade for approxi-
mately one minute till it cools down.
WARNING
The blade must be properly pushed down into its blade holders to
enable the temperature sensor to measure the correct blade
temperature.
CAUTION
The cutting blade of Sterile Tube Fuser - Dry is a thin piece of stain-
less steel. It does not have a sharpened edge but can cause cuts if
handled improperly. Be sure to read and understand the procedure
for installing and removing the blade.
CAUTION
Do not attempt to connect liquid-filled tubing using Sterile Tube
Fuser - Dry, or allow liquid to spill into the instrument.
CAUTION
Holders must not be mounted on the Sterile Tube Fuser - Dry
during initial alignment of the system.
NOTICE
Make sure that the cover lock button is down during the welding
and aligning operation.
2 Safety instructions
2.1 Safety precautions
16 Sterile Tube Fuser - Dry and Hot Lips Tube Sealer Operating Instructions 28964139 AG

NOTICE
Cover must be closed for the instrument to operate. The cover
interlock will only allow it to be opened when it is safe. The cover
lock button pops out to indicate that the cover is released and can
be opened.
Hot Lips Tube Sealer
WARNING
Before starting Hot Lips Tube Sealer please make sure that no
objects/tubes are kept in between the heating jaws or moving path.
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.
CAUTION
If there is liquid in the tubing when using Hot Lips Tube Sealer it will
evaporate as it comes into contact with the heater pads. If the tube
is full of liquid, the liquid can be released during the weld and can
cause a spill in or around the equipment.
NOTICE
Do not spill liquid into Hot Lips Tube Sealer. This can cause serious
damage and will void the warranty.
2 Safety instructions
2.1 Safety precautions
Sterile Tube Fuser - Dry and Hot Lips Tube Sealer Operating Instructions 28964139 AG 17

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
that the temporary clamps or plugs are secure.
Maintenance
Sterile Tube Fuser - Dry and Hot Lips Tube Sealer
WARNING
Electrical shock hazard. All repairs should be done by service
personnel authorized by Cytiva. Do not open any covers or replace
parts unless specifically stated in the user documentation.
WARNING
Disconnect power. Always disconnect power from the instru-
ment before performing any maintenance task.
WARNING
If a fuse requires repeated replacement, do not continue to use the
instrument. Contact an authorized service engineer.
WARNING
For continued protection from fire hazard, replace only with same
type and rating of fuse.
Refer to Section 8.1 Specifications, on page 94 for fuse specification.
CAUTION
Change the blade after every cut to avoid sterility issues.
2 Safety instructions
2.1 Safety precautions
18 Sterile Tube Fuser - Dry and Hot Lips Tube Sealer Operating Instructions 28964139 AG

2.2 Labels
Introduction
This section describes the system label and other safety or regulatory labels that are
attached to Sterile Tube Fuser - Dry and Hot Lips Tube Sealer.
System label
The system label is located on the back of the equipment. The system label identifies
the equipment and shows electrical data, regulatory compliance, and warning
symbols.
Description of symbols on the system
label
The following symbols and text may be present on the system label:
Symbol/text Meaning
Code no Instrument assembly number
Serial no Instrument serial number
Mfg Year Year (YYYY) and month (MM) of manufacture
Voltage
Frequency
Max Power
Max Current
Fuse
Electrical requirements:
•Voltage (VAC )
•Frequency (Hz)
•Max. power (VA)
•Max. current (A)
•Fuse rating
Warning! Read the user documentation before using the
system. Do not open any covers or replace parts unless
specifically stated in the user documentation.
2 Safety instructions
2.2 Labels
Sterile Tube Fuser - Dry and Hot Lips Tube Sealer Operating Instructions 28964139 AG 19

Safety labels on Sterile Tube Fuser -
Dry
The safety labels are located on Sterile Tube Fuser - Dry as illustrated below. The labels
warn the user of risk of personal injury.
2 Safety instructions
2.2 Labels
20 Sterile Tube Fuser - Dry and Hot Lips Tube Sealer Operating Instructions 28964139 AG