Thermo Scientific VARIOKLAV 65 TC User manual

50112712_082007_GB
VARIOKLAVTM
Steam sterilizer 65 TC
Operating manual

1 User considerations
Thermo Scientific 2 50112712_082007_GB
Copyright
© 2007 Thermo Fisher Scientific Inc. all rights reserved
Trademarks
VARIOKLAV is a registered trademark of Thermo Fisher Scientific and of its subsidiary
companies.
All other trademarks mentioned in the operating instructions are the exclusive property
of the respective manufacturers.
CE-Conformance mark
The product is marked to the nameplate with:
0123
Producer:
Thermo Electron LED GmbH
Robert-Bosch-Straße 1
D-63505 Langenselbold
Inland
Phone sales: 0800 1 53 63 76
Phone service: 0800 1 11 21 10
Fax: [phone]
International:
Phone: [phone]
Fax: [phone]
Internet: www.thermo.com
Email: [email protected]
Authorized service:
Hille Technische Dienstleistung GmbH
Lichtenbergstraße 8
D-85748 Garching bei München
Inland
Phone: [phone]
Emergency - Phone: [phone]
Fax: [phone]
International:
Phone: [phone]
Emergency - Phone:[phone]
Fax: [phone]
Internet: www.hille-technik.com
Email: [email protected]

1 User considerations
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Contents
1User considerations......................................................................................5
2Safety considerations...................................................................................7
2.1 In case of emergency........................................................................... 13
2.1.1 Mains circuit breaker..................................................................... 13
2.1.2 TERMINATION program............................................................... 14
2.2 Residual sterilizing risks....................................................................... 15
3Unpacking the sterilizer............................................................................. 16
4Putting the sterilizer into service.............................................................. 17
4.1 Tests..................................................................................................... 20
4.2 Scope of delivery.................................................................................. 21
4.3 Warranty periods.................................................................................. 21
4.4 Installation............................................................................................. 22
4.5 Installation site...................................................................................... 23
4.5.1 Heat emanation............................................................................. 24
4.5.2 Storage and ambient conditions................................................... 24
4.5.3 Mechanical circulation cooler........................................................ 24
4.6 Operator instructions............................................................................ 24
4.6.1 Instructions for daily operation...................................................... 24
4.6.2 Instructions for maintenance......................................................... 25
4.7 Device log............................................................................................. 25
4.8 Controlling the batch............................................................................. 26
5Short operating manual............................................................................. 27
6Equipment description .............................................................................. 28
6.1 Components ......................................................................................... 28
7Function ...................................................................................................... 33
7.1 Safety features...................................................................................... 34
8Preparing for sterilization.......................................................................... 35
8.1 Requirements for operation.................................................................. 36
8.2 Preparing the sterilizing chamber......................................................... 37
8.2.1 Sterilizing programs...................................................................... 38
8.2.2 Sterilization control........................................................................ 43
8.2.3 Daily release of the sterilizer......................................................... 50
8.3 Preparing the sterilization load............................................................. 51
8.3.1 Packaging types pursuant to DIN EN 868-1 (05-97).................... 51
8.3.2 Steel wire baskets......................................................................... 52
8.3.3 Sterilization containers.................................................................. 53
8.3.4 Loading the sterilizing chamber.................................................... 54
9Selecting sterilizing programs.................................................................. 57

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10 Settings ....................................................................................................... 58
10.1 Extending the drying time ................................................................. 58
10.2 Adjusting the removal pressure........................................................ 59
10.3 Setting date, time and timer.............................................................. 59
10.4 Turning the acoustic signal on and off.............................................. 62
10.5 Activating the Preheating key ........................................................... 62
11 Starting and running a program ............................................................... 64
11.1 Batch documentation........................................................................ 65
11.2 Batch documentation evaluation....................................................... 66
12 Program end and removal......................................................................... 68
13 Maintenance information........................................................................... 70
13.1 After-sales service and maintenance................................................ 71
13.2 Important notes................................................................................. 71
13.3 Inserting paper rolls into the integrated printer................................. 72
13.4 Changing the ribbon of the integrated printer................................... 73
14 Troubleshooting......................................................................................... 74
15 Preparations for transport (frost protection) .......................................... 78
15.1 Recommissioning.............................................................................. 80
16 Packing the sterilizer ................................................................................. 81
17 Opening the door without power.............................................................. 82
18 Technical specifications, abridged .......................................................... 83
18.1 Recommended feed water quality according to DIN EN 285:2006.. 83
19 Glossary...................................................................................................... 84

1 User considerations
Thermo Scientific 5 50112712_082007_GB
1 User considerations
This operating manual is directed at users and operators (or their representatives) of
VARIOKLAV Type 65 TC benchtop steam sterilizers. It deals with personal safety
and sterilization reliability and quality.
DANGER
The VARIOKLAV Type 65 TC benchtop sterilizer must only be
operated by skilled or semi-skilled personnel able to ensure its
proper operation. In Germany, its use is subject to the
Regulation for the Operation of Medical Devices
(Medizinprodukte-Betreiberverordnung – MPBetreibV –) of
June 1998.
This audience consists of three target groups:
Target group 1: Skilled hospital hygiene and sterilization staff
Target group 2: Semi-skilled hospital hygiene and sterilization staff
Target group 3: Service technicians skilled for medical units
Operators and target groups 1 and 3 should read the entire operating manual and
its supplements. Chapters 1 through 10 are directed at target group 2.
Correct use
INFORMATION
Thermo will only release load samples in accordance with the
validation documentation as available to the persons
responsible for supply matters.
The VARIOKLAV Type 65 TC benchtop sterilizer is a Class IIa medical device
pursuant to EU Guideline 93/42/EEC. The sterilizer is intended for use in a clinical
environment. Prior to sterilization, all items must be thoroughly cleaned and
disinfected. The items to be sterilized must be packaged in accordance with their
intended use. Sterile packaging must conform to all applicable EN and national
standards. Packaged hollow, solid, or porous items may be sterilized.
The unit can be used as follows:
ÖFor sterilizing solids such as glassware, heat-resistant rubber items, massive
metal items (instruments, bowls).
ÖFor sterilizing and drying porous materials, textiles, or tubes where it is
indicated that these are suitable for steam sterilization.
ÖImplants certified for steam sterilization by the manufacturer and possessing no
lumens or fillings.

1 User considerations
Thermo Scientific 6 50112712_082007_GB
Incorrect use
Liquids must not be sterilized either in open or in pressure-sealed containers.
The following products are not suitable for sterilization:
•Wooden items,
•Bonded parts,
•Plastic materials sensitive to hot water (e.g. screw tops),
•Electrical equipment,
•Food,
•General or hospital waste (e.g. C waste),
•Items containing the CJD pathogen,
•Medical drugs,
•Syringes filled with liquid,
•Metering equipment, unless their suitability for steam sterilization is
specifically mentioned,
•Anhydrous oils, fats and paraffins,
•Pulverized and dust-like matter.
Staff requirements
Routine operating staff
Commissioning and routine operations may be performed only by specially trained
personnel. These must possess the requisite knowledge for correct use (DIN
58946-6) of the sterilizer, including routine evaluation of the sterilization result
(release).
Supervisory and training staff
Supervisory and monitoring tasks are restricted to personnel possessing
comprehensive subject-matter expertise. They must be able to perform tasks
involving responsibility and to make decisions. In addition, they must be able to
train the routine operating staff and to pass on to them the requisite knowledge and
experience. This in turn presupposes suitable training as trainers (cf. DIN 58946-6,
Sterilization, Steam Sterilizers, Section 4.2).
The tasks of the supervisory personnel include:
•Daily release of the sterilizer after evaluating the results of the
mandatory daily tests (see Chapter 8.2.2).
•Deciding on the release of non-approved sterile packs.
•Evaluation of operating situations and process where performance
values lie outside the prescribed limits or threshold limit values and
necessary measures where required.
Conventions
zIndicates a list.
♦Indicates an operating step.
ÖIndicates alternatives.

2 Safety considerations
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2 Safety considerations
For your own safety, you should observe the following safety warning signs.
The warning signs indicate a possible source of danger.
At the same time they contain information on how correct action can avert danger.
You will always find warning signs attached to points of possible danger.
Safety warnings are indicated by the following signs on a grey background:
DANGER
This sign refers to hazardous situations.
Hazards to human life are indicated by the word “Life
Hazard”.
DANGER
This sign refers to explosion hazards.
 DANGER
This sign refers to dangerous voltages.
 CAUTION
This sign indicates danger to equipment and machinery.
INFORMATION
This sign indicates easier working practices.
On the following pages all safety warnings are listed to give you an overview.
Information concerning an easier working practice will appear at the appropriate
places in the text.
LIFE HAZARD
No matter what the problem, never use force when opening or
closing the swing door of the sterilizer. Life hazard!
The system might be damaged!

2 Safety considerations
Thermo Scientific 8 50112712_082007_GB
DANGER
The VARIOKLAV Type 65 TC benchtop sterilizer must only be
operated by skilled or semi-skilled personnel able to ensure its
proper operation. In Germany, its use is subject to the
Regulation for the Operation of Medical Devices
(Medizinprodukte-Betreiberverordnung – MPBetreibV –) of
June 1998.
DANGER
Read the detailed operating manual before switching on the
sterilizer. Keep the manual in a safe place to assist other
operators.
DANGER
Only run the sterilizer for correct use.
DANGER
If problems occur that might be harmful to persons or
property, the unit must be immediately disconnected from the
media supply!
Disconnect the feed water supply where appropriate.
DANGER
Should any anomalies and / or problems occur while the
sterilizer is ready for use or while running a sterilization cycle:
Press the START/STOP key to terminate any ongoing
programs, if necessary.
DANGER
Prior to the first sterilization, the sterilizer must be validated.
DANGER
If a program is interrupted, the load must be re-sterilized for
safety reasons.
DANGER
Hot steam may escape when door (1) is opened.
Scalding hazard!
Step back when opening the sterilizer.
DANGER
You must wear heat-isolating protective gloves and long-
sleeved working clothes when opening and loading the
sterilizing chamber (9) and when removing the sterilized
articles: Watch for hot surfaces and hot steam!

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Thermo Scientific 9 50112712_082007_GB
DANGER
Mobile phones (cell phones) may interfere with the execution
of programs and therefore must be turned off at the installation
site or near the control unit of the sterilizer.
DANGER
Repairs and modifications are restricted to specially
authorized.
DANGER
Take note of all warning signs attached to the sterilizer.
DANGER
Perform repeated checks to assure the quality of sterilization.
The purpose of these checks is to protect both patients and
personnel. Observe the maintenance instructions in the ring
binder supplied with the sterilizer.
DANGER
Pursuant to DIN 58946-6, the sterilizer operator is obliged to
keep a device log to document important parameters and
events.
DANGER
Perform batch documentation and sterilizer release
documentation pursuant to DIN 58946-6 (June 2000).
DANGER
Never use test media (Bowie & Dick simulation test pack, batch
control indicator for helix test) whose shelf life has expired.
DANGER
Perform the Vacuum & Empty and Bowie & Dick test programs
once daily.
This allows you to check sterilizing conditions and sterilization
quality on a daily basis.
DANGER
To ensure uniform testing conditions, it is recommended to
perform the Bowie & Dick test when the sterilizer is hot. To
insure this, execute the Vacuum & Empty program first.

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DANGER
If the indicator strip of the test object with indicator system
(helix test) does not reveal four uniformly blackened bars,
optimal sterilizing conditions are not ensured. In this case,
please contact a service agency without delay and stop using
the sterilizer.
DANGER
If the indicator test sheet of the STERICLIN Bowie & Dick
single-use test pack does not change its colour uniformly and
thoroughly, optimal sterilizing conditions are not ensured.
In this case, please contact a service agency without delay and
stop using the sterilizer.
DANGER
If the Bowie & Dick test program is interrupted for some
reasons, a new test must be performed for safety reasons.
Make sure that the test frame and the test pack are in non-
heated condition and replace the Bowie & Dick indicator test
sheet.
There must be no water droplets inside the rolled-up helix test
tube (i.e. the test object with indicator system).
DANGER
Make sure that no cloth ends dangle from the sterilization
container when the items are wrapped in order to avoid non-
sterile batches.
DANGER
Each time a sterilization container is to be used, the paper filter
in the lid and (where appropriate) the bottom is to be checked.
This will guarantee safe storage conditions. Replace the filter if
necessary.
DANGER
Check the sterilized items for apparent damage. Damaged and
/ or moist packaged items must be considered non-sterile.