Thermo Scientific VARIOKLAV 25T User manual

VARIOKLAVTM
Steam sterilizer 25T
Operating Manual
Issue 03/2007

03/2007 2DA0621_a
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Contents
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Contents
1Safety considerations ...........................................................................................7
1.1 In case of emergencies ........................................................................ 10
1.1.1 Disconnecting from mains............................................................. 10
1.1.2 TERMINATION program............................................................... 10
1.2 Residual sterilizing risks ....................................................................... 11
2Short operating manual ..................................................................................... 12
3Equipment description ....................................................................................... 13
3.1 Components ......................................................................................... 13
4Function............................................................................................................. 17
4.1 Options ................................................................................................. 18
4.2 Special programs.................................................................................. 19
4.3 Safety features...................................................................................... 19
4.3.1 Exhaust air filtration (Types FA, FA/FS) ....................................... 19
4.3.2 Thermolock ................................................................................... 20
5Preparing for sterilization................................................................................... 21
5.1 Preparing the sterilizing chamber......................................................... 22
5.2 Preparing the items to be sterilized ...................................................... 22
5.2.1 Rack system.................................................................................. 22
5.2.2 Practical tips for different types of items ....................................... 23
5.2.3 Loading the sterilizing chamber .................................................... 25
6Programs ........................................................................................................... 26
6.1 Selecting a sterilizing program ............................................................. 27
6.2 Setting the sterilizing temperature........................................................ 28
6.3 Setting the sterilizing time..................................................................... 29
6.4 Setting the multiple sterilization number............................................... 29
6.5 Selecting or deselecting options (acoustic signal or integrated printer)30
6.6 Setting the timer.................................................................................... 31
7Starting and running a program......................................................................... 32
7.1 Batch documentation (option) .............................................................. 34
8Program end and removal................................................................................. 36
9Configuring programs........................................................................................ 38
10 Initial commissioning ......................................................................................... 42
10.1 Scope of delivery .............................................................................. 43
10.2 Warranty periods............................................................................... 44
10.3 Legal regulations............................................................................... 44
10.3.1Free movement pursuant to European Pressure Equipment
Directive 97/23/EC .................................................................................. 44
10.3.2Operating the device according to the German Operating Safety
Regulation ............................................................................................... 44
10.4 Installation......................................................................................... 44
10.4.1Connecting the steam sterilizer to the disposal system:............... 45
10.4.2Connecting the steam sterilizer to the supply system: ................. 47
10.5 Commissioning of the options........................................................... 48
10.5.1Type RM fast recooling system .................................................... 48
10.6 Calibration, qualification, validation .................................................. 49

Contents
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11 Maintenance and cleaning ................................................................................ 51
11.1 After-sales service and maintenance................................................ 52
11.2 Important notes ................................................................................. 52
11.3 Inserting paper rolls into the integrated printer ................................. 53
11.4 Changing the ribbon of the integrated printer ................................... 54
12 Troubleshooting................................................................................................. 55
13 Technical specifications .................................................................................... 57
14 Glossary............................................................................................................. 58

User considerations
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User considerations
This operating manual is directed at users and operators (or their representatives) of
VARIOKLAV Type 25 T bench-top steam sterilizers.
This audience consists of three target groups:
Target group 1: Trained laboratory staff
Target group 2: Semi-skilled laboratory staff
Target group 3: Auxiliary staff
Operators and target group 1 should read the entire Operating manual and its
supplements. Chapters 1 through 9 are directed at target groups 2 and 3.
Correct use
The VARIOKLAV Type 25 T benchtop sterilizer is intended for the following
purposes:
ÖSterilizing solid items such as glassware, rubber items, pipette tips, instruments,
filter housings, as well as consumables, waste, and to destroy infectious or
septic materials.
ÖSterilizing liquids such as solutions and culture media in open or slightly closed
vessels, including cooling to a reference temperature below 90 °C to allow safe
removal.
ÖSterilizing food.
ÖSteaming liquids or dissolving agar-agar.
ÖWith Vacuum pump option only: Sterilizing and drying porous materials, fabric,
or tubes.
ÖWith Type ST supporting pressure, Radial fan and Type RM water recooling
system option only: Sterilizing liquids in pressure-sealed vessels (e.g. flasks,
bags).
Incorrect use
Easily combustible or toxic liquids must not be sterilized!
The following products are not suitable for sterilization:
•Wooden items,
•Bonded parts,
•Plastic materials sensitive to hot water (e.g. screw tops),
•Electrical equipment,
•Vessels or instruments made from steel or iron,
•Metering equipment, unless their suitability for steam sterilization is
specifically mentioned.

User considerations
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Pictographs
You will find the following pictographs in this operating manual:
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.
♦Indicates an operating step.
ÖIndicates alternatives.
Abbreviations
You will find a glossary of technical terms and abbreviations in Chapter 14.

1 Safety considerations
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1 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.

1 Safety considerations
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DANGER
Read the detailed operating manual before switching on the
sterilizer. Keep the manual in a safe place to assist other
operators.
DANGER
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
power supply by pulling out the mains plug from the socket!
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.
DANGER
If a program is interrupted, the load must be re-sterilized for
safety reasons.
DANGER
Only run the sterilizer for correct use.
DANGER
Only sterilize waste in open vessels (e.g. metal boat with
closed bottom).
DANGER
Do not open the sterilizing chamber (8) until removal is
signalled.
Watch for hot steam and hot water!
Scalding hazard!
Follow the specified operating steps to the letter.
DANGER
Hot steam may escape when the door is opened.
Scalding hazard!
Step back when opening the sterilizer.
DANGER
You must wear the following protective items when opening
the sterilizing chamber (8) and removing the sterilized articles:
yApron,
yEye protectors,
yHeat-insulated gloves.
Watch for hot surfaces and hot steam!

1 Safety considerations
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DANGER
Do not sterilize pressure-sealed vessels.
Explosion hazard!
Watch for broken glass!
Scalding hazard!
CAUTION
Take note of all warning signs attached to the sterilizer.
CAUTION
The equipment must not be operated in hazardous locations!
CAUTION
When sterilizing liquids:
Do not fill the vessels more than two-thirds full,
as otherwise liquids may boil over.
CAUTION
Only use deionized or distilled water when topping up feed
water. Do not use tap water!
CAUTION
During the heating phase, contaminated exhaust air or waste
water may be emitted from the sterilizer to the on-site disposal
system.
Remedy: Type FA exhaust air filtration expansion option.
CAUTION
Take care to ensure that the door seal (6) is:
free from dirt, not sticking to the door (2), and not damaged.
The door seal (6) must sit snugly in the groove.
CAUTION
Before sterilization, check to see whether there is enough feed
water in the feed water tank (4).
Only use deionized or distilled water when topping up the feed
water.
Do not use tap water!
CAUTION
In order to guarantee smooth operation and prevent corrosion
damage, please follow the checklists for regular maintenance
and care and the maintenance manual to the letter!
CAUTION
Before opening, check to see if the indicated pressure has
dropped below the set removal pressure (factory setting: 110
kPa).

1 Safety considerations
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1.1 In case of emergencies
1.1.1 Disconnecting from mains
DANGER
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!
CAUTION
If problems occur that might be harmful to persons or
property, the unit must be immediately disconnected from the
power supply by pulling out the mains plug from the socket!
INFORMATION
The mains plug socket of the sterilizer must be freely
accessible. In case of failures, it is used to disconnect the
sterilizer from mains.
The sterilizer is disconnected from mains.
Contact the authorized Thermo service:
1.1.2 TERMINATION program
CAUTION
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.
INFORMATION
To deactivate the Preheating program, press the Preheating
key (22).
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 THERMO service:

1 Safety considerations
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CAUTION
If a program is interrupted, the load must be re-sterilized for
safety reasons.
1.2 Residual sterilizing risks
The VARIOKLAV Type 25 T 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
problems, indicates and documents them (bath documentation, option), and directs
the user to the correct reaction (troubleshooting, re-sterilization):
Even when all technical prerequisites for safe sterilization 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 for routine maintenance and care enumerated in
the Maintenance Manual (weekly, monthly, semi-annually and annually).
•Feed water impurities.
•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 only validates the test loads.
•Damaged items must be considered non-sterile.
•If the sterilizer is deployed in a different place, environment conditions
may change.

2 Short operating manual
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2 Short operating manual
INFORMATION
Attach the short operating manual close to the sterilizer.

3 Equipment description
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3 Equipment description
3.1 Components
Figure 1: VARIOKLAV 25 T
12 34
5
6
7
8
9
10
11
12

3 Equipment description
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Figure 2: VARIOKLAV 25 T control panel, detail
Figure 3: Printer control panel, detail
1 Door : Closes the sterilizing chamber.
2 Locking lever (inside the
inner door moulding)
: Lock the door. Two locking levers keep the
closed door tightly locked to the housing anchors
(7).
3 Case : The case contains the control elements and
fittings.
Zyklus Betrieb
Tür Start/Stop
Konfig.
P
1
P
2
P
3
Zeit
Kammer
Mantel
Medium
Kammer
Start
Vakuum
Aufheizen
Sterilisieren
Abkühlen
Trocknen
Zyklus Ende
°C
°C
kPa
kPa
min
Cycle Operation
Door Start/Stop
Config.
P
1
P
2
P
3
Time
Chamber
Jacket
Liquid
Chamber
Start
Vacuum
Heating
Sterilization
Recooling
Drying
End of Cycle
°C
°C
kPa
kPa
min
13 14 15 16 17
18
26
27
25
19
20
21
22
23
24

3 Equipment description
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4 Feed water tank with
glass cover
(optional with spent-
steam condenser)
: The feed water tank contains the feed water
(deionized water) used to generate the sterile
steam. The glass cover protects the feed water
from contamination.
The spent-steam condenser (option)
subsequently condenses the steam, which can
then be disposed of separately or returned to the
feed water tank.
5 Control panel : Keys and switch keys for programming; displays.
6 Door seal : Seals the sterilizer door.
7 Anchors for locking
levers
: This is where the locking levers (2) engage when
the door is closed.
8 Sterilizing chamber : Chamber in which items are sterilized.
9 Rack system (accessory) : Accommodates the insert trays with the items to
be sterilized.
10 Feed water tank drain : Connector for draining the feed water tank. A
piece of hose with a suitable coupling is included.
(The jacket space is emptied using a special
jacket evacuation program; see Maintenance
Manual.)
11 Condensate gutter
(accessory)
: Catches condensate that has formed on the door
or in the chamber.
12 Insert tray : For placing items in the sterilizing chamber.
13 Current values display : Indicates the current conditions prevailing in the
sterilizing chamber
Chamber temperature (in °C)
(additionally, if Media temperature control option
is installed: Media temperature, in °C)
Chamber pressure (in kPa)
(additionally, if Drying option is installed: Jacket
pressure, in kPa)
(additionally, if the Multiple sterilization special
program is installed: Number of remaining
sterilization cycles)
Remaining sterilizing time or drying time (in min)
14 ▲key : Increases values of sterilization parameters.
15 ▼key : Decreases values of sterilization parameters.
16 Cycle display : Shows set temperature, multiple sterilization
number (option), sterilizing time, and the name of
the selected program.
17 Key-operated switch : The software and hardware versions can be
viewed only when the key-operated switch is
turned to the configuration position (“Konfig.”).
18 Program keys : Select the sterilizing program.
19 Green START/STOP key : Turns the sterilizer on and starts the sterilization
process.
20 Door indicator : Indicates the condition of the door:
yellow door closed, locked.
green door open, unlocked.
While the door is being locked or unlocked by the
locking levers, both indicator lights are off.

3 Equipment description
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21 Acoustic signal key : Turns the acoustic signal (buzzer) at program
end on or off.
22 Preheating key : Out of function
23 Timer key : Turns the timer on or off, and for checking the
preset date or time.
24 Sterilization phase
display
: Shows the phases of a sterilization cycle.
25 Printer cover : Covers the printer head, the ribbon, and the
paper roll (option).
26 Printer ON/OFF key : Turns the printer on or off.
27 Paper feed key : Advances the printer paper.
The VARIOKLAV Type 25 T steam sterilizer is a compact benchtop unit with an
electrical heater built into the jacket space:
The feed water is pumped from the feed water tank to the jacket space where it is
heated. The heated feed water then supplies the sterilizing steam. The sterilizing
steam is introduced directly into the sterilizing chamber (8). A rigidly mounted
temperature sensor is measuring the chamber temperature.
The following components are stored in the case (3):
•the sterilizing chamber (8),
•the safety valve,
•the feed water tank (4),
•the control panel (5).
The control panel (5) is used to select sterilization parameters and to start the
sterilizing program. Sterilizing chamber (8) pressure and temperature are shown
on the control panel display.
The built-in timer is used to set a start time for the sterilization cycle.
The sterilizer may include additional expansion options indicated on the front page.
Expansion options are described in Chapter 4.
We highly recommend having the sterilizer serviced regularly by an authorized
service agency. Furthermore, please observe the Maintenance Manual. This will
give you guaranteed trouble-free, safe operation and a long service life.
We offer you a low-priced yearly safety check and benefits such as calibration and
qualification (see Chapter 10.6).

4 Function
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4 Function
VARIOKLAV Type 25 T benchtop sterilizers are used to sterilize and disinfect
various kinds of articles.
Standard Equipment Program Items / Special Notes
Instruments Solid items such as instruments,
filter housings, glassware, rubber
items, pipette tips and food.
Destruction
(Waste)
Used consumables, infectious or
septic materials which need to be
destroyed.
Liquids Liquids in open or slightly closed
vessels.
Expansion Option
Type RM water recooling
system
Liquids RM Liquids in open or slightly closed
vessels; recooling reduces batch
times.
Media temperature control All Liquids
programs
Flexible media temperature sensor:
sterilizing time actuated by media
temperature.
Type FA exhaust air
filtration
All programs Safety feature: sterile air filter.
Water post-feed All programs Sterilization cycles > 40 min.
Batch documentation All programs Sterilization values are logged.
Furthermore, this unit is suitable for non-pressurized steaming of liquids, culture
media and solutions at 98 °C.
The functional description will start by presenting the basic functions of the
VARIOKLAV Type 25 T benchtop sterilizers. In addition, you will find here a
description of the expansion options.
The VARIOKLAV Type 25 T benchtop sterilizer is microprocessor-controlled. This
means that sterilization can proceed without supervision. You must set the desired
sterilizing program on the control panel (5).
The P1, P2, and P3program keys (18) are preset for programs for different types of
sterilizing items. The program settings can only be changed permanently
(configured) when the key-operated switch is turned to the configuration position
(“Konfig.”) (see Chapter 9).
Once the program has started, the sterilizing chamber is first closed automatically.
The control panel (door indicator, 20) indicates the electronic and mechanical door
lock (yellow). Now the sterilizing chamber is sealed with the pneumatic door seal:
the inflatable seal is pressed onto the door using pressurized air.
The sterilizing chamber (8) is automatically heated and deaerated. At a chamber
temperature of 96 °C, the sterilizing chamber (8) is again deaerated for further 3

4 Function
03/2007 18 DA0621_a/
minutes.Once the specified sterilizing temperature has been reached, the
sterilizing time will start running. Then the sterilizer is used as a steam pot (set
temperature of 98 °C), no pressure builds up in the sterilization chamber (8).
When the sterilizing time has run out, the sterilizing chamber (8) cools according to
the selected program:
•Instruments program: rapid pressure release to a removal pressure
below 110 kPa .
•Waste (Destruction) program: delayed pressure release to a removal
pressure below 110 kPa .
•Liquids: slow pressure release. The sterilization cycle is not ended until
the reference temperature has dropped below 90 °C (thermolock).
In the case of the Multiple sterilization special program, the program cycle of
heating, sterilizing, cooling and drying (optional) repeats itself according to the
selected multiple sterilization number.
The sterilization phase display (24) shows the current status of program execution.
When the program has been completed, the acoustic signal will be sound and the
light in the green START/STOP key (19) will flash. Pressing the green
START/STOP key (19) will terminate the program. The door is unlocked, and the
door indicator (20) changes to green again.
The sterilizer is ready for a new cycle immediately after the sterilized items have
been removed and the feed water tank has been filled up (if required) with
deionized water.
4.1 Options
ÖMedia temperature control
With this option, the sterilizer is additionally equipped with a flexible
temperature sensor. The flexible temperature sensor measures the media
temperature in a reference flask. In all Liquids programs, the sterilizing timer
is not actuated until the media has reached the sterilizing temperature. The
program is not terminated until the media temperature has dropped below
90 °C. The thermolock prevents the sterilizer from being opened
prematurely. This allows safe removal of liquid sterilizing articles at the end
of sterilization.
ÖType RM water recooling system
With this option, the sterilizer is additionally equipped with a fast recooling
system. In the Liquids RM program, cooling water is led through a separate
cooling coil within the jacket space during the cooling phase. This cools the
sterilizing chamber from outside, and batch times are shortened.
ÖType FA exhaust air filtration
With this option, the sterilizer is additionally equipped with a sterile air filter
(FA) (see also Chapter 4.3.1). The exhaust air filtration is effective in all
programs. Once commissioned, it can not be decommissioned. In this way
you can exclude the possibility that contaminated materials are sterilized
without exhaust air filtration. The cycle display (16) now also shows the filter
symbol .

4 Function
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ÖWater post-feed
With the Water post-feed option, water is led within the jacket space not only
prior to sterilization, but more water is added as needed from the feed water
tank. In this manner, it is possible to implement sterilizing and steaming
times of up to 10019 minutes.
ÖBatch documentation
With this option, the sterilizer is additionally equipped with an integrated
printer for batch documentation. The integrated printer can operate in
parallel with any program. The printout logs the sterilization process
complete with date, batch number and sterilization parameters, as well as
any errors that have occurred during program execution.
A possible alternative is using the VARIOSOFT PC software for batch
documentation.
4.2 Special programs
ÖClimatic chamber
The benchtop sterilizer can be reprogrammed to serve as climatic chamber
for long-term ageing tests. This requires the presence of certain expansion
options.
The sterilizing time of all available programs must be set to ∞(infinity). Any
program selected and executed must then be terminated manually. The feed
water tank (4) level must be checked at regular intervals.
ÖMultiple sterilization
The benchtop sterilizer can be reprogrammed for multiple sterilization for
testing. This means that the complete sterilization cycle is executed several
times in succession. The number of cycles can be selected. This requires
the presence of certain expansion options. The feed water tank (4) level
must be checked at regular intervals.
4.3 Safety features
The VARIOKLAV Type 25 T benchtop sterilizer has various safety features,
including simple handling thanks to automated program control, which reduces the
number of operator errors, and a sophisticated error management system that
monitors and reports technical problems or defects. The enclosed diagram gives
you an overview over structural and programmed safety features.
4.3.1 Exhaust air filtration (Types FA, FA/FS)
The steam sterilizer may be equipped with a sterile air filter (Type FA expansion
option) as an additional safety feature. The exhaust air filtration system prevents
the escape of micro-organisms from the sterilizer during deaeration. This is
necessary for safe and emission-free sterilization of contaminated materials,

4 Function
03/2007 20 DA0621_a/
especially in maximum-containment laboratories1). The entire filter housing is itself
sterilized during each sterilization cycle and is therefore protected from
contamination.
If another sterilizer expansion option requires a sterile air filter (Types FS, FL), the
sterile air filter will be present in the form of a combination filter Types FA/FS,
FA/FL, or FA/FS/FL. This combination filter serves two functions simultaneously:
sterile venting and exhaust air filtration. Sterile venting prevents pathogens from
entering the sterilizing chamber during pressurized aeration at the end of the
sterilization cycle or during aeration at the end of a vacuum drying phase. The
combination filter is also itself sterilized during each sterilization cycle.
4.3.2 Thermolock
The steam sterilizer is equipped with a thermolock2)) as safety feature. The
thermolock prevents any opening of the sterilizing chamber as long as the
reference temperature remains above 90 °C3). The thermolock is effective in all
Liquids programs. The current values display (13) shows the reference
temperature for checking (instead of the media temperature) during the cooling
phase. During sterilization, by contrast, the reference temperature is not shown (- -
-).
The sterilizer may be equipped additionally with a flexible temperature sensor
(media temperature control expansion option). This flexible temperature sensor
has a pressure-sealed entry point through the back wall of the sterilizing chamber.
In all Liquids programs, the flexible temperature sensor measures media
temperature as the reference temperature. This temperature is the input value for
controlling the thermolock. The media temperature is continuously displayed in the
current values display (13).
The program steps door locking, heating and automatic deaeration, sterilizing, and
cooling are performed automatically. As soon as the liquid temperature drops
below 90 °C, the thermolock is turned off. The program is terminated, and the door
can be opened.
In case of a power failure or if no electrical outlet is available, the thermolock will
always remain switched on. The door is locked. It can only be opened when power
is restored. The door is also locked when the thermolock is active, but the flexible
temperature sensor is defective.
1) Genetic Engineering Safety Regulations dated March 21, 1995 (A II 2.): “For all operations during
which aerosols could be produced, these must be prevented from reaching the work area.”
2) Temperature-controlled safety system for liquids to prevent retardation of boiling in accordance with
TRB 402 (3.2.4.), AD instruction A5, DIN 58 950 and DIN 58 951.