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
Thermo Scientific 3 50112712_082007_GB
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!

2 Safety considerations
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.

2 Safety considerations
Thermo Scientific 10 50112712_082007_GB
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.

2 Safety considerations
Thermo Scientific 11 50112712_082007_GB
DANGER
Should the sterilizer remain unused for more than three hours
and cool down, a renewed sterilization check is recommended.
Perform the Vacuum & Empty and Bowie & Dick test programs.
DANGER
If the safety valve does not react to a higher pressure than the
set nominal pressure1), cease using the sterilizer immediately.
Do not use it again until a new and fully functional safety valve
is installed.
DANGER
For more detailed information concerning maintenance consult
the maintenance instructions in the ring binder supplied with
the sterilizer.
DANGER
Repairs and interventions may only be carried out by our
authorized after-sales service.
DANGER
Any repairs and interventions concerning the sterilizer must be
documented in the device log.
DANGER
If an error message is displayed during the sterilization
process, the load must be considered non-sterile.
DANGER
Only use the emergency unlocking aid to open the sterilizer
door when the sterilizing chamber is not under pressure.
DANGER
The supply voltage and supply frequency must be the same as
given on the type plate.
Only connect the sterilizer to the specified socket.
DANGER
When a fault occurs and for maintenance purposes,
disconnect the steam sterilizer from the mains supply.
Pull the mains plug or neutralize the fuse.
1)See type plate.

2 Safety considerations
Thermo Scientific 12 50112712_082007_GB
CAUTION
A mains circuit breaker with an ELCB switch and the CEE
socket must be installed in the immediate vicinity of the unit.
CAUTION
Be careful when connecting media supply lines.
Danger of water-related damage!
CAUTION
Do not deploy the unit in the direct vicinity of a fire alarm.
Exiting steam could set off the fire alarm.
CAUTION
Take care to ensure that the door seal (7) is:
free from dirt, not sticking to the door (1), and not damaged.
The door seal (7) must sit snugly in the groove.
CAUTION
The equipment must not be operated in hazardous locations!
CAUTION
Before sterilization, check to see whether there is enough feed
water in the feed water tank (5).
Only use deionized water when topping up the feed water.
Do not use tap water!
CAUTION
Only use deionized or distilled water when topping up feed
water. Do not use tap water!
Feed water quality pursuant to DIN EN 285.
CAUTION
For error-free operation and to avoid corrosion damage,
carefully follow the maintenance manual.

2 Safety considerations
Thermo Scientific 13 50112712_082007_GB
2.1 In case of emergency
2.1.1 Mains circuit breaker
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!
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.
CAUTION
A mains circuit breaker with an ELCB switch and the CEE
socket must be installed in the immediate vicinity of the unit.
The sterilizer is disconnected from mains.
♦In emergencies contact the authorized Thermo service:
+49 / 173 / 97 27 74 3

2 Safety considerations
Thermo Scientific 14 50112712_082007_GB
2.1.2 TERMINATION program
DANGER
Should any anomalies and / or problems occur while the
sterilizer is ready for use or while running a sterilization cycle:
Press the green START/STOP key to terminate any ongoing
programs, if necessary.
Examples of possible anomalies or problems:
•Steam escapes from behind the cover or from the disposal area;
•Water dropping from the bottom of the unit;
•Incorrect choice of program with adverse consequences for the items to
be sterilized (e.g. excessive sterilization temperatures).
Pressing the START/STOP key terminates the sterilizing program. The device will
enter a state in which the load can be safely removed.
If you had inadvertently chosen an inappropriate program:
♦Select the correct sterilizing program for your load.
♦Start the newly selected sterilizing program.
In case of anomalies and problems:
♦Contact the authorized service:
DANGER
If a program is interrupted, the load must be re-sterilized for
safety reasons.

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Thermo Scientific 15 50112712_082007_GB
2.2 Residual sterilizing risks
The VARIOKLAV Type 65 TC benchtop sterilizer ensures safe sterilization, when
used as directed and if the appropriate sterilizing program has been chosen for the
load to be sterilized. A complex error management system monitors the unit for
technical problems2) , indicates and documents them, and directs the user to the
correct reaction (troubleshooting, re-sterilization):
Even when all technical prerequisites for safe sterilizations exist, sterility of the load
cannot be guaranteed.
There is always a residual risk, depending in part on the care with which the user and
operator perform their respective tasks:
•Omission of the checks enumerated in the maintenance manual.
•Feed water impurities.
•Using tap water with a high chloride concentration instead of deionized
water
•Insufficient cleaning and disinfection of the load.
•The efficacy of a sterilizing program for the actual user load, even given
a constant consumable supply situation, can only be demonstrated by a
validation process. The manufacturer has only validated the test loads
pursuant to DIN EN 285.
•That a Bowie & Dick test was passed during the daily start-up
procedure only proves that steam penetration was satisfactory at the
time of testing. Any deterioration occurring as the day progresses will
remain unnoticed.
•Damaged and / or moist packaged items must be considered non-
sterile.
•If the sterilizer is deployed in a different place, environment conditions
may change.
2) E.g. deviant process-relevant parameters as per DIN EN 285

3 Unpacking the sterilizer
Thermo Scientific 16 50112712_082007_GB
3 Unpacking the sterilizer
12 1
1a 1d 1e
2 x
1 x
IV
II III
VVI
VII
1b
I
VIII
B
1c
45°
2 x
3
4
12
3
3
A
VIII
11
2
4
1 x
In order to commission the VARIOKLAV Type 65 TC steam sterilizer, please follow the Initial
Commissioning Instructions to the letter.

4 Putting the sterilizer into service
Thermo Scientific 17 50112712_082007_GB
4 Putting the sterilizer into service
DANGER
The supply voltage and supply frequency must be the same as
given on the type plate.
Only connect the sterilizer to the specified electrical sockets.
DANGER
Prior to the first sterilization, the sterilizer must be validated.
CAUTION
A mains circuit breaker with an ELCB switch and the CEE
socket must be installed in the immediate vicinity of the unit.
INFORMATION
Three-phase motor: The vacuum pump requires a mains
connection with a clockwise rotating field. If the rotary field is
incorrect, the message "Check rotary field" appears.
CAUTION
Be careful when connecting tap water and disposal lines.
Danger of water-related damage!
CAUTION
Only use deionized feed water3). Do not use tap water!
CAUTION
Do not deploy the unit in the direct vicinity of a fire alarm.
Exiting steam could set off the fire alarm.
INFORMATION
Consult the Initial Commissioning Instructions for information
on how to set the removal pressure for the jurisdiction in
which the sterilizer is to be deployed.
INFORMATION
The temperature of the cooling water influences the suction
power of the water ring vacuum pump: The colder the cooling
water, the higher the vacuum attained.
3) Recommended values as per DIN EN 285 (1997), Annex B.

4 Putting the sterilizer into service
Thermo Scientific 18 50112712_082007_GB
INFORMATION
The door locking mechanism is electro-mechanically locked as
delivered! Connect to mains to unlock and terminate transport
program.
INFORMATION
You may use a separate condensate collector if the room
climate is not adversely affected by the excess heat, hot
condensate or spent steam generated during sterilization. Do
not use the "tap water" connection as otherwise the collector
may overflow and cause water damage.
Especially in case of contaminated exhaust air, the water in the
collector as well as the collector itself may be infected with
germs. This factor is to be considered when disposing of the
collector content.
The steam sterilizer is marked with a type plate of the manufacturing company.
This type plate lists all the technical specifications required for classification of the
pressure vessel and steam boiler. A spare-parts store for this instrument is
maintained at the manufacturer's factory. Availability of parts is guaranteed for 10
years.
The VARIOKLAV Type 65 TC steam sterilizer has been marked with the four-digit
CE mark and the number of the Notified Body (TÜV), 0123, pursuant to Section
9 of the German Medical Devices Law. It has undergone conformity assessment
pursuant to the EU Guideline 93/42/EEC (Article 11, Annex II). The Declaration of
Conformity is based on a complete quality assurance system pursuant to DIN EN
ISO 9001 (1994).
The sterilizer has been manufactured according to the requirements of EN DIN 285
(02/97).
The steam sterilizer meets the general requirements of and has undergone testing
pursuant to DIN EN 60601 and the threshold limits for electromagnetic
compatibility (EMC) contained therein. This German standard is also a VDE
standard (VDE 0750).
VARIOKLAV Type 65 TC sterilizers are not machines4) pursuant to the EU
Machinery Directive 89/392/EEC (steam boilers, tanks and pressure vessels are
explicitly excluded).
The pressure equipment and steam boiler (double wall) comply with the new
Pressure Equipment Directive 97/23/EC.
The following operating documents are supplied with the delivery (as invoiced):
- Declaration of Conformity for the sterilizer pursuant to the European Guideline
concerning Medical Devices 93/42/EEC
4) Excerpt from the Council Directive ”Machinery” 89/392/EEC:
Article 1
(2) For the purposes of this directive, "machinery" means an assembly of linked parts or components, at
least one of which moves, with the appropriate actuators, control and power circuits, etc., joined
together for a specific application, in particular for the processing, treatment, moving or packaging of a
material. The term "machinery" also covers an assembly of machines which, in order to achieve the
same end, are arranged and controlled so that they function as an integral whole.
(3) The following are excluded from the scope of this Directive:
steam boilers, tanks, and pressure vessels.

4 Putting the sterilizer into service
Thermo Scientific 19 50112712_082007_GB
The unit comes with the following documentation:
- Technical description of the sterilizer;
- Certificate of factory testing as performed by Thermo Electeron
- Description for the required consumables and their quality level as
applicable to steam sterilizers pursuant to DIN 58946 Part 7;
- Operating manual with instructions for first use and error codes for
troubleshooting by the operator;
- Short Operating Manual
- Initial Commissioning Instructions
- Packing instructions;
- Maintenance Manual
- Settings for the automatic control system and pressure, temperature
and time values for all important parts of the sterilization cycle;
- Technical specifications including functional description and flow
diagram (FI diagram);
- Electrical circuit diagrams with legends;
- List of spare parts.
- Calibration logs of the temperature sensor and the pressure sensors
respectively

4 Putting the sterilizer into service
Thermo Scientific 20 50112712_082007_GB
4.1 Tests
Type testing
Type testing consists of a series of tests for confirming the functional data for a
specific type of sterilizer (DIN EN 285:1997).
Type testing was performed by the manufacturer on a representative 65 TC steam
sterilizer following the guidelines laid out in DIN EN 285 (February 1997). The
requisite tests ensure that the values for the physical sterilization parameters are
within the prescribed range, using an independent and calibrated measuring
system. All sterilizing programs are tested without load and with partial and full
loads (see Tables 2, 3 and 4). The unit is also tested for air leaks (vacuum test),
and a Bowie & Dick test is performed.
Factory testing
Factory testing includes a series of tests performed at the manufacturer’s site in
order to demonstrate for each sterilizer that the unit performs in accordance with
applicable specifications (DIN EN 285:1997).
Within the framework of pre-acceptance testing at the factory, each sterilizer is
factory tested. This means that an independent, calibrated measuring system is
used to determine whether or not the sterilization process uses the predetermined
parameters. The Bowie & Dick test program is also tested. A test for air leaks
(vacuum test) is performed as well.
Acceptance test
Acceptance testing consists of a series of checks and tests performed on-site after
deployment of the sterilizer (DIN EN 285:1997). The owner or operator usually lets
the manufacturer or an authorized service agency perform this test.
Any additional tests (such as installation checks and microbiological testing) will
also be agreed between the operator and the manufacturer.
Within the framework of commissioning, each sterilizer is subjected to acceptance
testing. This means that an independent, calibrated measuring system is used to
determine whether or not the sterilization process uses the predetermined
parameters. The Bowie & Dick and Textiles programs are tested with different
loads as representative of the other programs. A test for air leaks (vacuum test) is
performed as well.
Validation
Validation is a documented procedure for obtaining, recording and interpreting data
required to show that a process will consistently comply with predetermined
specifications (see EN 554).
Validation of sterilization processes pursuant to Section 4, paragraph 2 of the
German Regulation for Operators of Medical Devices (MPBetriebV) has to be
applied for by the owner and can only be performed by the operator. Suitable
validating aids are available from Thermo Electron on request.