cytiva ReadyToProcess STF - Dry User manual

ReadyToProcess™ STF – Dry
Operating Instructions
Original instructions
cytiva.com

Table of Contents
1 Introduction ........................................................................................................ 4
1.1 Important user information ....................................................................................................................... 5
1.2 About this manual ......................................................................................................................................... 6
1.3 Associated documentation ....................................................................................................................... 7
2 Safety instructions ............................................................................................. 8
2.1 Safety precautions ........................................................................................................................................ 9
2.2 Labels and symbols ....................................................................................................................................... 17
2.3 Emergency procedures ............................................................................................................................... 20
2.4 Danger zone ..................................................................................................................................................... 21
3 Instrument description ...................................................................................... 22
4 Installation .......................................................................................................... 24
4.1 Site requirements .......................................................................................................................................... 25
4.2 Transport .......................................................................................................................................................... 26
4.3 Unpacking ......................................................................................................................................................... 27
4.4 Electrical connections ................................................................................................................................. 28
4.5 Connecting the printer to ReadyToProcess STF – Dry (optional) ................................................ 29
5 Operation ............................................................................................................ 30
5.1 Cover lock for ReadyToProcess STF – Dry ............................................................................................ 31
5.2 Tube fusing process ..................................................................................................................................... 32
5.2.1 Operational overview .................................................................................................................................. 33
5.2.2 Fusing tubes ................................................................................................................................................... 35
5.2.3 Inspecting weld quality .............................................................................................................................. 42
5.3 Updating the Tubing Database ................................................................................................................. 43
6 Maintenance ....................................................................................................... 44
6.1 Cleaning before planned service ............................................................................................................. 45
6.2 Cleaning the instrument ............................................................................................................................. 46
6.3 Regular maintenance of ReadyToProcess STF – Dry ........................................................................ 49
6.4 Replacement of fuses ................................................................................................................................... 50
6.5 Storage .............................................................................................................................................................. 52
7 Troubleshooting ................................................................................................. 53
8 Reference information ....................................................................................... 59
8.1 Specifications .................................................................................................................................................. 60
8.2 Compatible tubing for ReadyToProcess STF – Dry ........................................................................... 61
8.3 Blade contact materials for ReadyToProcess STF – Dry ................................................................ 63
8.4 Recycling information .................................................................................................................................. 64
8.5 Regulatory information ............................................................................................................................... 65
8.5.1 Contact information .................................................................................................................................... 66
8.5.2 European Union and European Economic Area .............................................................................. 67
8.5.3 Great Britain ................................................................................................................................................... 68
8.5.4 Eurasian Economic Union (Евразийский экономический союз) .......................................... 69
Table of Contents
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8.5.5 North America ............................................................................................................................................... 71
8.5.6 Regulatory statements .............................................................................................................................. 72
8.5.7 Declaration of Hazardous Substances (DoHS) ................................................................................ 73
8.5.8 Other regulations and standards .......................................................................................................... 75
8.6 Ordering information ................................................................................................................................... 76
8.7 Health and Safety Declaration Form ...................................................................................................... 77
Index ........................................................................................................................... 79
Table of Contents
ReadyToProcess STF – Dry Operating Instructions 29724820 AA 3

1 Introduction
About this chapter
This chapter contains important user information, intended use of ReadyToProcess™
STF – Dry instrument, and lists of associated documentation.
In this chapter
Section See page
1.1 Important user information 5
1.2 About this manual 6
1.3 Associated documentation 7
1 Introduction
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1.1 Important user information
Introduction
This section contains important user information about the product and this manual.
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 the product
ReadyToProcess STF – Dry is an automated instrument designed to produce sterile
joints of thermoplastic tubings.
ReadyToProcess STF – Dry shall not be used in any clinical procedures, or for diagnostic
purposes.
Prerequisites
In order to operate the instrument 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 Oper-
ating Instructions.
•The instrument must be installed according to the instructions in the Installation
chapter of the Operating Instructions.
1 Introduction
1.1 Important user information
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1.2 About this manual
Introduction
This section contains information about the purpose and scope of this manual, notes
and tips, and typographical conventions.
Purpose of this manual
This manual provides information needed to install, operate and maintain the product
in a safe way.
Scope of this manual
This manual is valid for ReadyToProcess STF – Dry. The images and annotations in this
document are for illustrative purposes only.
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.
Typographical conventions
Software items are identified in the text by bold italic text.
Hardware items are identified in the text by bold text.
Tip: The text can include clickable hyperlinks to reference information.
1 Introduction
1.2 About this manual
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1.3 Associated documentation
An installation kit for tube data management is available upon request. The tool helps
ReadyToProcess STF – Dry to support different tubing types and manage the factory
loaded tubing types.
Sterile Tube Fuser - Dry and Hot Lips Tube Sealer Tube Data Management Tool, User
Manual, 28999329 is supplied with an installation kit.
For more information on tubing, see Section 8.2 Compatible tubing for ReadyToProcess
STF – Dry, on page 61.
1 Introduction
1.3 Associated documentation
ReadyToProcess STF – Dry Operating Instructions 29724820 AA 7

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 9
2.2 Labels and symbols 17
2.3 Emergency procedures 20
2.4 Danger zone 21
Important
WARNING
All users must read and understand the entire contents of
this general safety chapter, and the specific safety precau-
tions information in each subsequent chapter of this manual
to become aware of the hazards involved.
2 Safety instructions
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2.1 Safety precautions
Introduction
ReadyToProcess STF – Dry is powered by mains voltage and handles materials that can
be hazardous.
Before installing, operating, or maintaining the product, you must be aware of the
hazards described in this manual.
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.
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.
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.
2 Safety instructions
2.1 Safety precautions
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WARNING
The customer must make sure that all installation, maintenance,
operation, and inspection is carried out according to local regula-
tions by adequately trained personnel.
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.
CAUTION
Do not attempt to connect liquid filled tubing using the product.
This will void the warranty.
2 Safety instructions
2.1 Safety precautions
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NOTICE
Class A product.Class A products 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.
Personal protection
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
WARNING
The product is not designed to fuse tubing containing flammable
fluids.
WARNING
The product is not approved for work in a potentially explosive
atmosphere.
2 Safety instructions
2.1 Safety precautions
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Installing and moving the
instruments
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.
WARNING
Use lifting handles located on either side of the instrument to lift
the product. Use personal protective equipment to avoid any kind
of personal injury.
CAUTION
Disconnect all tubing, hoses and external cables before moving the
unit.
CAUTION
The product has fragile items. Make sure the product is always in
upright position during transport, movement and storage. Also
make sure no weight is kept on the instrument or instrument pack-
aging.
2 Safety instructions
2.1 Safety precautions
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Operation
WARNING
Electrocution risk. 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.
WARNING
Burn and pinch hazard. The instrument can be run with open
cover in setup mode. Use caution in setup mode, with the Program-
ming lock key horizontal, and keep clear of the blade, blade
assembly & movable parts. The blade poses a burn hazard and
movable parts poses a pinch hazard if the weld process is started in
this mode.
WARNING
Hot surface. The cutting blade reaches 400°C during the heating
cycle. Do not try to open the protective cover during the welding.
WARNING
Pinch hazard. 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
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WARNING
Hot surface. Do not touch the blade of the product until it cools
down. Always allow the blade to cool down for 30 seconds before
accessing the blade.
WARNING
Hot surface. In case of power failure and instrument reset, the
product 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
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
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CAUTION
Depending on the tubes used in the product, hazardous gases may
be emitted. Make sure to use the instrument in a room with proper
ventilation.
CAUTION
The cutting blade of the product is a thin piece of stainless steel. It
does not have a sharpened edge but can cause cuts if handled
improperly. Make sure to read and understand the procedure for
installing and removing the blade.
CAUTION
Do not attempt to connect liquid-filled tubing using the product, or
allow liquid to spill into the instrument. Use a clamp to stop liquid
from re-entering.
CAUTION
Holders must not be mounted on the product during initial align-
ment of the instrument.
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
Make sure that the tube type and size matches the type of program
selected. Mismatch in selection can cause damage to the unit and
is not covered under the warranty.
2 Safety instructions
2.1 Safety precautions
ReadyToProcess STF – Dry Operating Instructions 29724820 AA 15

See Section 8.2 Compatible tubing for ReadyToProcess STF – Dry, on page 61 for a list
of tubing types that have been tested for the instrument.
Maintenance
WARNING
Electrical shock hazard. All repairs must 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.
See Section 8.1 Specifications, on page 60 for fuse specification.
CAUTION
Change the blade after every cut to avoid sterility issues.
2 Safety instructions
2.1 Safety precautions
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2.2 Labels and symbols
Introduction
This section describes the nameplate, labels, and other safety and regulatory informa-
tion attached to the product.
Nameplate
The nameplate provides information about the model, manufacturer, and technical
data.
Description of symbols and text
The following symbols and text may be present on the nameplate:
Symbol /
text
Description
Product no. Ordering number for the instrument
Code no Instrument assembly number
Serial
number
Instrument serial number
Mfg. Year Year (YYYY) and month (MM) of manufacture
Voltage Electrical rating:
•Voltage (VAC )
Frequency Electrical rating: Frequency (Hz)
Max. Power Electrical rating: Max. power (VA)
Fuse rating Fuse rating: number of fuses, type F (fast), trip current (A),
maximum voltage (V)
Protection
Class
Degree of protection provided by the enclosure
2 Safety instructions
2.2 Labels and symbols
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Description of safety labels
The safety labels are described in the table below. Make sure that you fully understand
the potential hazards indicated by the labels.
Symbol Description
Warning! Read the user documentation before using the
instrument. Do not open any covers or replace parts unless
specifically stated in the user documentation.
Warning! Read the user documentation before using the
instrument. Do not open any covers or replace parts unless
specifically stated in the user documentation.
Indicates a hot surface and that care must be exercised to
prevent injury.
Indicates a pinch hazard and that care must be exercised
to prevent injury.
2 Safety instructions
2.2 Labels and symbols
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Safety labels on the instrument
The safety labels are located on the instrument as illustrated below. The labels warn
the user of risk of personal injury.
2 Safety instructions
2.2 Labels and symbols
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2.3 Emergency procedures
Introduction
This section describes how to shut down ReadyToProcess STF – Dry in an emergency
situation. The section also describes the result in the event of power failure.
Emergency shutdown of
ReadyToProcess STF – Dry
Switch off the power by pressing the power switch to the "O" position.
The power switch is located at the rear of the instrument, see the illustration below.
Disconnect the power cord from the power outlet.
Power failure
In case of power failure during the welding operation, the tubes may not be welded
completely.
Restart after emergency shutdown or
power failure
When power is restored after a power failure or emergency shutdown, re-initiate the
welding process by following the instructions displayed on the touch screen.
2 Safety instructions
2.3 Emergency procedures
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