cytiva Sterile Tube Fuser - Wet User manual

Sterile Tube Fuser - Wet
Operating Instructions
Original instructions
cytiva.com

Table of Contents
1Introduction ........................................................................................................ 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 Symbols and abbreviations ........................................................................................................................ 20
2.3 Emergency procedures ............................................................................................................................... 23
2.4 Danger zone ..................................................................................................................................................... 25
3 Instrument description ...................................................................................... 26
4 Installation .......................................................................................................... 30
4.1 Site requirements .......................................................................................................................................... 31
4.2 Transport .......................................................................................................................................................... 32
4.3 Unpacking ......................................................................................................................................................... 33
4.4 Electrical connections ................................................................................................................................. 34
4.5 Connecting the printer to Sterile Tube Fuser - Wet (optional) ..................................................... 35
5 Operation ............................................................................................................ 36
5.1 Overview ............................................................................................................................................................ 39
5.2 Cover lock ......................................................................................................................................................... 42
5.3 Fusing tubes ..................................................................................................................................................... 43
5.4 Changing tubing holder ............................................................................................................................... 51
5.5 Inspecting weld quality ................................................................................................................................ 52
5.6 Updating the Tubing Database ................................................................................................................. 54
6 Maintenance ....................................................................................................... 55
6.1 Cleaning before planned service ............................................................................................................. 56
6.2 Cleaning ............................................................................................................................................................ 57
6.3 Regular maintenance .................................................................................................................................. 60
6.4 Replacement of fuses ................................................................................................................................... 61
6.5 Storage .............................................................................................................................................................. 63
7 Troubleshooting ................................................................................................. 64
8 Reference information ....................................................................................... 69
8.1 Specifications .................................................................................................................................................. 70
8.2 Compatible tubing for ................................................................................................................................. 71
8.3 Blade contact materials ............................................................................................................................. 72
8.4 Further information ...................................................................................................................................... 73
8.5 Recycling information .................................................................................................................................. 74
8.6 Regulatory information ............................................................................................................................... 75
8.6.1 Contact information .................................................................................................................................... 76
8.6.2 European Union and European Economic Area .............................................................................. 77
Table of Contents
2 Sterile Tube Fuser - Wet Operating Instructions 29024010 AD

8.6.3 Eurasian Economic Union
Евразийский экономический союз .................................................................................................. 78
8.6.4 Regulations for North America ............................................................................................................... 80
8.6.5 Regulatory statements .............................................................................................................................. 81
8.6.6 Declaration of Hazardous Substances (DoHS) ................................................................................ 82
8.6.7 Other regulations and standards .......................................................................................................... 84
8.7 Health and Safety Declaration Form ...................................................................................................... 85
Index ........................................................................................................................... 87
Table of Contents
Sterile Tube Fuser - Wet Operating Instructions 29024010 AD 3

1 Introduction
About this chapter
This chapter contains important user information about the Sterile Tube Fuser - Wet
instrument, 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 - Wet Operating Instructions 29024010 AD

1.1 About this manual
Purpose of this manual
The Operating Instructions provide you with the instructions needed to handle Sterile
Tube Fuser - Wet 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 - Wet Operating Instructions 29024010 AD 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 install, operate, or perform maintenance on the product in any other way than
described in the user documentation. If you do, you may be exposed or expose others
to hazards that can lead to personal injury and you may cause damage to the equip-
ment.
Intended use of Sterile Tube Fuser -
Wet
Sterile Tube Fuser - Wet is an automated instrument designed to produce sterile joints
of thermoplastic tubings.
Sterile Tube Fuser - Wet shall not be used in any clinical procedures, or for diagnostic
purposes.
Prerequisites
In order to operate Sterile Tube Fuser - Wet 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 Chapter 2 Safety instructions, on page 9
•The instrument must be installed according to the instructions in Chapter 4 Installa-
tion, on page 30.
Definitions
This user documentation contains safety notices (WARNING, CAUTION, and NOTICE)
concerning the safe use of the product. See definitions below.
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.
1 Introduction
1.2 Important user information
6 Sterile Tube Fuser - Wet Operating Instructions 29024010 AD

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 - Wet Operating Instructions 29024010 AD 7

1.3 Associated documentation
Introduction
This section describes the documentation delivered with Sterile Tube Fuser - Wet.
Supplied documentation
In addition to the Operating Instructions, the Sterile Tube Fuser - Wet instrument is
supplied with an Operator Manual:
Document Contents
Sterile Tube Fuser - Wet Operator
Manual (supplied with Sterile Tube
Fuser - Wet)
How to use the system, including
concepts, methodology, operation and
troubleshooting.
These documents are also available as
online help.
1 Introduction
1.3 Associated documentation
8 Sterile Tube Fuser - Wet Operating Instructions 29024010 AD

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.
In this chapter
Section See page
2.1 Safety precautions 10
2.2 Symbols and abbreviations 20
2.3 Emergency procedures 23
2.4 Danger zone 25
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.
2 Safety instructions
Sterile Tube Fuser - Wet Operating Instructions 29024010 AD 9

2.1 Safety precautions
Introduction
Sterile Tube Fuser - Wet is powered by mains voltage and handles 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 instrument
•System operation
•Maintenance
General precautions
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 - Wet Operating Instructions 29024010 AD

WARNING
Hazardous substances. When using hazardous chemical and
biological agents, take all suitable protective measures, such as
wearing protective glasses and gloves resistant to the substances
used. Follow local and/or national regulations for safe operation,
maintenance and decommissioning of the system.
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
Do not operate the product in any other way than described in the
user documentation.
WARNING
Operation and user maintenance of Sterile Tube Fuser - Wet
should be performed by properly trained personnel only.
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.
2 Safety instructions
2.1 Safety precautions
Sterile Tube Fuser - Wet Operating Instructions 29024010 AD 11

NOTICE
This equipment is not intended for use in residential environments
and may not provide adequate protection to radio reception in
such environments.
NOTICE
Only use PTFE coated cutting blades (BLADES-IR/50) specified for
use with Sterile Tube Fuser - Wet. For optimal use, do not reuse
blades.
Personal protection
WARNING
Always use appropriate personal protective equipment during
installation, operation, inspection, maintenance and cleaning of
Sterile Tube Fuser - Wet.
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.
WARNING
Do not attempt to weld two different tube materials. This may lead
to poor weld/no weld and spillage.
WARNING
Do not attempt to access moving parts and heating zone during
welding operation by any means.
2 Safety instructions
2.1 Safety precautions
12 Sterile Tube Fuser - Wet Operating Instructions 29024010 AD

CAUTION
Depending on which tubes that are used to weld in Sterile Tube
Fuser - Wet, hazardous gases may emit due to blade heating and
tube melting. Make sure to use the instrument in a room with
proper ventilation.
NOTICE
High pressures can be generated if the liquid in the tube weld area
has no place to go when it is locked down by the tube holders.
Before locking the tube holders make sure the liquid is displaced
upstream or downstream of weld and then secure external clamps
or plugs.
Using flammable liquids
WARNING
Sterile Tube Fuser - Wet is not designed to handle flammable
liquids.
WARNING
Sterile Tube Fuser - Wet is not approved for work in a potentially
explosive atmosphere.
Installing and moving the instrument
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.
2 Safety instructions
2.1 Safety precautions
Sterile Tube Fuser - Wet Operating Instructions 29024010 AD 13

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.
WARNING
Use lifting handles located on either side of the instrument to lift
Sterile Tube Fuser - Wet. Use personal protective equipment to
avoid any kind of personal injury.
CAUTION
Disconnect all tubing, hoses and external cables before moving the
unit.
CAUTION
Sterile Tube Fuser - Wet has fragile items. Make sure Sterile Tube
Fuser - Wet is always in upright position during transport, move-
ment and storage. Also make sure no weight is kept on the instru-
ment or instrument packaging.
System operation
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.
2 Safety instructions
2.1 Safety precautions
14 Sterile Tube Fuser - Wet Operating Instructions 29024010 AD

WARNING
Inspect all connections and tubing before start and replace any
defective parts.
WARNING
Use external tubing clamps on both tubes to avoid large amount of
liquid spillage and contamination of the complete process batch
incase of poor weld or weld failure.
WARNING
In case of spillage, proper cleaning agents should be used to clean
the instrument, holders and clamps depending on the hazard level
of the process chemicals/biologicals being used.
WARNING
Remove external clamps only after confirming a good weld joint.
WARNING
In setup mode of Sterile Tube Fuser - Wet, 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
Pinch hazard when using Sterile Tube Fuser - Wet. 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 - Wet Operating Instructions 29024010 AD 15

WARNING
Hot surfaces of Sterile Tube Fuser - Wet. The cutting blade
reaches 400°C during the heating cycle. Do not try to open the
protective cover during the welding.
WARNING
Do not touch the blade of Sterile Tube Fuser - Wet 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 -
Wet unlocks the cover lock.
•Do not touch the blade for approximately one minute till it cools
down.
•If there is liquid spillage due to poor weld or no weld, clean the
spillage using proper cleaning agent depending on the hazard
level of the process chemicals/biologicals being used and
continue with tube welding process.
WARNING
The blade must be properly pushed down into its blade holders to
enable the temperature sensor to measure the correct blade
temperature.
WARNING
Visually inspect the weld joint before unlocking the tube holders. In
case of poor weld, no weld or liquid spillage inside the instrument,
switch off the instrument before attempting to remove the tubes.
WARNING
Use external tubing clamps on both tubes to avoid electrical shock
hazard due to large amount of liquid spillage and contamination of
the complete process batch in case of poor weld or weld failure.
2 Safety instructions
2.1 Safety precautions
16 Sterile Tube Fuser - Wet Operating Instructions 29024010 AD

CAUTION
Make sure that the tubes are properly clamped with external
clamps on both sides of the weld. This ensures that the sterility of
the processing fluid is not compromised if any ruptures emerge
during inspection. Make sure that the tubings do not come apart or
start to crack.
CAUTION
Use only tubing that is compatible with the instruments.
CAUTION
The cutting blade of Sterile Tube Fuser - Wet 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
Visually inspect the weld joint for any leakage before loosening
tube holder knob.
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.
2 Safety instructions
2.1 Safety precautions
Sterile Tube Fuser - Wet Operating Instructions 29024010 AD 17

NOTICE
Make sure that the cover lock button is down during the welding
and aligning operation.
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.
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 - Wet, refer to
Section 8.2 Compatible tubing for, on page 71
Maintenance
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.
2 Safety instructions
2.1 Safety precautions
18 Sterile Tube Fuser - Wet Operating Instructions 29024010 AD

WARNING
For continued protection from fire hazard, replace only with same
type and rating of fuse.
Refer to Section 8.1 Specifications, on page 70 for fuse specification.
CAUTION
Change the blade after every cut to avoid sterility issues.
2 Safety instructions
2.1 Safety precautions
Sterile Tube Fuser - Wet Operating Instructions 29024010 AD 19

2.2 Symbols and abbreviations
Introduction
This section describes the information on the system label and other safety or regula-
tory labels that are attached to the product.
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.
System label description
The following symbols may be found on the system label.
Symbol/text Meaning
Sterile Tube
Fuser - Wet
Name of product
29004170 Catalogue number
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.
This symbol indicates that the waste of electrical and elec-
tronic equipment must not be disposed as unsorted munic-
ipal waste and must be collected separately. Please contact
an authorized representative of the manufacturer for infor-
mation concerning the decommissioning of equipment.
2 Safety instructions
2.2 Symbols and abbreviations
20 Sterile Tube Fuser - Wet Operating Instructions 29024010 AD