DECLARATON OF CONFORMITY „CE“
In accordance to the following directives
97 / 23 / EG for equipment under pressure
used modul: A
Type and model of products;
Autoclave Type : KL – 5 - 3
Autoclave Type : KL – 7 - 3
Autoclave Type : KL – 12 - 2
It is declared that the above mentioned products in conception and
type of construction, also in the mode of design traded by us, meet the
above directives.
This declaration is going to loose its validity in case of changes not
agreed by us.
Used harmonised regulations:
DIN EN 10028 - 7
Used national regulations/technical specifications:
AD – Merkblatt A 2
ADOLF WOLF SANOclav
Bad Überkingen , 07.01.2003
Adolf Wolf .
Directing Manager
Table 8: Survey of the inspection, maintenance and cleaning work
Inspection Maintenance Cleaning
Visual inspection be-
Rubber gasket of the
vessel lid
Valves
Heater
Autoclave
Sterilizationprocess
* Please contact us in the event of uncertainty. We will be happy to supply you with
any information required.
for each sterilization
process:
Ensure that the
gasket is intact
before starting!
Visual inspection befor each sterilization
process:
Watch for grime!
Monthly visual inspection:
Watch for scaling!
The autoclave must
be checked every
2-3 years by the
manufacturer!
Recalibrate the temperature and pressure indicator yearly.
Check effectiveness* in conformity
with DIN 58946-8
every 6 month.
The rubber gasket is
a wearing part.
It must be renewed
in the event of damage or wear.
For safety reasons
the lid must be
returned to the
manufacturer when
the valve has become
clogged.
Eco-friendly descaling
with vinegar at a moderate temperature.
After sterilization
autoclaves must be
stored in an open
condition.
Carefully remove
grime with water.
Do not try to
clean yourself!
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Monthly cleaning
of the inside depending upon the
frequency of use.
Do not use a
scouring agent!
Check of Temperature and pressure indicator:
The autoclave is to heat up to 1 bar and 2 bar. Than the following data have to appear:
Pressure: 1bar Temperature: 121°C
Pressure: 2bar Temperature: 134°C
If there are any deviations the autoclave has to be checked by
the manufacturer or, pressure -, respectively temperatureindicator has to be replaced.
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4 Optional extras: Media sensor
The media sensor can only be used in conjunction with the
MCS control (see fig.2 page 23)
WARNING: Do not open the exhaust steam valve after
the sterilization of liquids (media) due to the danger of
delayed boiling. Allow the autoclave to cool down naturally.
Only open the autoclave, when
⇒ the chamber temperature has cooled down to at
least 70°C
⇒ the autoclave has no remaining pressure (0 bar)
The media sensor is used to establish the actual temperature of
a liquid (medium) that is to be sterilized during the heating-up
and cooling-down stages. The sensor is directly immersed in
the medium (reference container).
1. Activation of the media sensor (see fig. 2 page 23)
a) To activate the media sensor press the "E" key before
the autoclave is started with the "F" key. The LED indicator (6) lights up to confirm that the media sensor has
been switched on.
b) Press the "E" key to call the media temperature during
the sterilization process.
c) NOTE: When a media sensor is being used the sterili-
zation time only commences when the medium has
reached the setpoint temperature.
An additional sterilization time as described under chapter
2.6.2 therefore is not necessary.
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1 Safety Instructions
„SANOclav" stands for state-of-the-art small-batch autoclaves (small
sterilizers). All safety-technical aspects, in so far as they are within
the manufacturer's sphere of control, have been taken into account.
The series KL and TKL autoclaves are insufficiently equipped
for sterilisation of medical products within the meaning of the
European Guideline 93/42/CCE and are therefore not suitable.
For causes outside the manufacturer's sphere of control, no responsibility is accepted for consequential damage, injury to the
sterilization product, device, appliance or the surrounding area.
The basic prerequisite for operation ensuring freedom of hazard
to a great degree is that:
• the devices are only used by persons who can offer the
guarantee for proper handling on the basis of their training
or their knowledge and practical experience.
• These Operating Instructions, as well as any other appropriate additional documents, must be made available to the
operating personnel at all times for their work. Operating
personnel are obliged to observe these Operating Instructions and other documents.
• Unqualified personnel are not allowed to work at the autoclaves or be in their vicinity.
• The autoclaves most not be technically changed in any
manner without previously consulting the manufacturer.
2.7.1 Trouble shooting for the MCS control
Table 7: Reason for error message and possible cause
Display Description Cause
Err 1
Err 2
Err 3
Err 4
Err 5
- - -
F
F
- - -
Table 8: Action after an error message
Display Acti on
Err 1
Err 2
Err 3
Err 4
Err 5
- - -
F
F
- - -
Operation was aborted during the
heating-up stage
Operation was aborted during the
sterilization period
Operation was interrupted Defective (broken) chamber sensor
Operation was interrupted Defective (broken) media sensor
Operation was interrupted
Arises when the device is switched
on or after Err 3 and Err 4
Arises when the device is switched
on or after Err 3 and Err 4
Repeat sterilization. Consult manufacturer if message reappears.
Repeat sterilization. Consult manufacturer if message reappears.
Autoclave must be repaired by the manufacturer
Autoclave must be repaired by the manufacturer
Check rubber gasket for proper seat in the lid and then repeat sterilization. Consult manufacturer if message reappears.
Autoclave must be repaired by the manufacturer
Autoclave must be repaired by the manufacturer
for example: Power failure
for example: Power failure
The chamber or media temperature
dropped by more than 2°C below the
setpoint temperature during a sterilization period of more than 2 minutes
Broken chamber sensor
Short-circuited chamber sensor
These safety instructions do not claim to be complete. In the
event of queries and problems please consult our specialists who
will be happy to help you and supply corresponding information.
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All error messages must be confirmed with the "F" key. This
resets the autoclave to its initial state. The messages "Err 3",
"Err 4" and "F---" cannot be followed by another operation. The
messages "F
---
" or "F
" appear when the "F" key (device
---
ON/OFF) is depressed.
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WARNING: Transport and installation:
1. Ensure that the room is well illuminated (at least 300
Lug). Incorrectly read measured values can result in
damage to the sterilization product or inadequate results.
2. To avoid damage due to radiated heat, autoclaves of
the KL and TKL series must be spaced by at least
0.5 m from heat sensitive walls. The base must be
heat-proof.
3. Unsuitable (sensitive to heat) wall panelling can be
damaged in the event of uncontrolled emission of hot
steam. We recommend the use of our condense
collecting container (see Chapter 3 "Accessories").
4. There is a danger of autoclaves toppling over if
they are placed on a sloping or soft base.
5. The risk of short circuits is greatly increased if moisture-sensitive devices (PC, meters, etc.) are set up in
the same room as the autoclaves.
6. The vapours of aggressive media (e.g. acids, lees,
various solvents, etc.) can corrode the autoclaves.
1. Fill the vessel with at least 1½ litre of water, but never more
than ¾ of the specified maximum vessel volume. The autoclave must never run dry.
2. Charge and close the autoclave in the manner described in
Chapters 2.6.1-1.
3. Open the exhaust steam valve right up to its stop point to
ensure proper venting during the heating-up stage. The
autoclave can now be switched on with its mains switch.
4. Setting the sterilization temperature ("C" key) and time ("D"
key): Press the given setpoint key (see fig. 1) and adjust the
required value with the edit keys. The actual temperature is
displayed after the settings have been completed.
5. Start the sterilization process by pressing the "F" key.
WARNING: Renewed depression of the "F" key terminates
the sterilization process (e.g. in the event of an incorrect entry).
B: During operation
WARNING: Please observe the "Safety Instructions"
and "Acceptable Risks" (Chapters 1. and 1.2), but
particularly the section "During Operation".
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6. The autoclave is adequately vented when a strong jet
steamis emitted by the pressure control valve (approx. 4
minutes at 99-100°C thermometer display). Close the
exhaust steam valve.
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8. In case of sterilization of adhesive fluids an Operating Test
of the Safety Valve has do be made before and after the
sterilization (see chapter 6.2)
9. In case of sterilization of fluids (in open containers) we recommend the use of a media sensor (see chapter 4)
2.7 Operation of small-batch autoclaves,
type „TKL-MCS“
WARNING: During operation:
1. An autoclave without MCS control must be constantly supervised during the sterilization process. It
may be necessary to readjust the steam pressure
control valve to avoid a short-fall or transgression of
the operating pressure.
2. Inadequate venting of the autoclave prior to sterilization will result in inadequate sterilization results.
Please refer to the corresponding details in these
Operating Instructions.
3. A short-fall of the operating temperature will result in
inadequate sterilization, while an excessive operating
temperature can damage the product being sterilized. Consequently, it must be ensured that autoclaves that do not feature an MCS control must
never be operated unattended.
4. The autoclave lid and walls become very hot during
operation. Contact with the autoclave in this condition can result in burns (except for the plastic handles).
5. To achieve the required sterilizing effect, the sterilization period for liquids must be extended by the additional time listed in table 6 page 19.
6.
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Steam release valve
Safety valve
Pressure gauge
Manometer main switch microcomputer
Fig. 1 TKL – Autoclave with MCS-controller
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B: After sterilizing liquids:
1. Let the autoclave cool down to at least 70°C
chamber temperature.
Liquid sterilization products will boil over on
account of delayed boiling and cause serious
burns if the steam pressure is vented instead of
allowing the autoclave to cool down slowly.
Only open the autoclave, when
⇒ the chamber temperature has cooled down
to at least 70°C
⇒ the autoclave has no remaining pressure (0 bar).
2. In case of sterilizing adhesive fluids an Operating Test of
the Safety Valve is necessary before and after the sterilization.(see chapter 6.2)
After a result of delayed boiling adhesive fluid can clog
up the valves. In such an event the autoclave lid must be
sent to the manufacturer so that the valves can be
checked.
Continued operation with clogged valves can result
in the explosion of the pressure vessel.
⇒Risk to Life !
C: After sterilization
WARNING: Please observe the "Safety Instructions"
and "Acceptable Risks" (Chapters 1. and 1.2), but
particularly the section "After Sterilization".
1. Do not vent the steam when sterilization has been completed
but rather allow the autoclave to cool down slowly to at least
70°C. Liquid sterilization products will boil over on account of
delayed boiling if the steam pressure is vented. In unfortunate circumstances such effect can gravely scald attending
operators.
2. Consequently, as a result of the delayed boiling effect, the
autoclave must only be opened after
⇒ it has cooled down to below 70°C.
⇒ there is no remaining pressure in it (0 bar)
3. In case of sterilizing adhesive fluids an Operating Test of the
Safety Valve is necessary before and after the sterilization.
(see chapter 6.2)
After a result of delayed boiling adhesive fluid can clog up the
valves. In such an event the autoclave lid must be sent to the
manufacturer so that the valves can be checked.
Continued operation with clogged valves can result in the
explosion of the pressure vessel.
⇒ Risk to Life!
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WARNING: Electromagnetic compatibility:
0
1. To guarantee proper sterilization after a mains
failure, the sterilization must be repeated for the
set time when the power has returned.
2. Do not complete any changes (e.g. a different
power supply cable) without previously consulting
the manufacture as this can adversely influence
the autoclave's immunity to malfunctions.
2 Details concerning use
2.1 Fields of application
The autoclaves of type „KL + TKL..“ are for:
Sterilization in high-pressure steam
C: After sterilization
WARNING: Please observe the „Safety Instructions“
and „Acceptable Risks“ (chapter 1 and 1.2), but particularly the section „After Sterilization“.
• Turn off the heater when the sterilization time has ended
• The steam pressure control valve can now be carefully
opened and the pressure slowly vented until there is no remaining pressure in the chamber (manometer = 0 bar)
• Let the autoclave cool down to at least 80°C
• Before opening the lid check again if there is no pressure
remaining in the chamber
• Now you can open the autoclave and take off the sterilization products.
2.6.2 Sterilization of liquids
A: Preparation for operation
Do not sterilize in those autoclaves:
⇒ packed solids
⇒ liquids in closed containers
⇒ further the following dangerous liquids:
• explosive
• high inflammatory
• easy inflammatory
• inflammatory (if the maximum allowed temperature
is above the flamepoint)
• very toxic
• toxic
• effective for burning
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WARNING: Please observe the "Safety Instructions" and "Acceptable Risks" (Chapters 1. and 1.2), but particularly the section "Preparations for Operation".
The same preparations are required as described in Section
2.6.1 A, except that the following additional and modified pre-
paratory work is necessary:
1. Do place the container holding the liquid to be sterilized deep
but not directly on the autoclave base.
CAUTION: Do not use closed containers. Closed containers
may lead to a retardation of ebullition (delayed boiling).
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2.2 Transport and installation
WARNING: Please observe "Safety Instructions" and
"Acceptable Risks" (Chapters 1. and 1.2), but particularly the section "Transport and Installation".
The following ambient conditions must be fulfilled to ensure
optimal autoclave operation:
• Ensure good lighting conditions.
• The base must be level, firm and resistant to heat.
• Ensure effective ventilation.
• TKL-MCS autoclaves must be connected to a socket with
earthed conductor (see Table 3 "Technical Data").
•
Maintain the following ambient parameters for TKL-MCS
autoclaves:
Table 2: Ambient conditions
Ambient conditions
Altitude for operation
Ambient temperature
Voltage fluctuations
Pollution
only indoors
up to maximum 2000 m
mean sea level
from 5°C to 40°C
maximum ±10% of rated
value
maximum Pollution Severity
Degree 2 acc. to IEC 664
2.6.1 Sterilization of solids
A: Preparations for operation
WARNING: Please observe the "Safety Instructions"
and "Acceptable Risks" (Chapters 1. and 1.2), but
particularly the section "Preparations for Operation".
1. The autoclave's lid must only be opened when the device is
in a pressureless state.
• If necessary, open the steam pressure valve. The closing
ever can be raised to a vertical position as soon as no
more steam is being emitted by the valve. This releases
the lid as it is lowered into the vessel.
• Turn the lid by 90° with its closing lever and then tilt
towards the valve side. The lid can then be removed.
2. Fill the vessel with at least 1,5 litre of water, but never more
than 3/4 of the specified maximum vessel volume.
The autoclave must never run dry.
The inserts are selected according to the products that are to
be sterilized: Sieve tray, sieve basket and test tube rack (see
Chapter 3 "Accessories").
3. The pressure vessel is closed by returning the lid in the
same manner.
• Turn the lid by 90° so that the cross bracing is inserted
precisely in the recessions in the edge of the vessel.
• Adjust the closing lever to its horizontal closing position. An
accurately inserted lid must be uniformly seated on the
vessel opening.
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Do not complete any changes (e.g. a different power supply cable)
without previously consulting the manufacture as this can adversely influence the autoclave's immunity to malfunctions.
2.5 General details concerning sterilization
with high-pressure steam
Table 4a
Field of application Requirements
concerning Emitted interference Interference immunity
Living area* EN 55011 EN 50082-1
Industrial area EN 55011 EN 50082-2
* Living area: Office rooms, workshops and laboratories, small enterprises
Table 4b: Details concerning severity with regard to interference immunity
Details on electromagnetic compatibility Inspection values
Interference immunity towards static
electricity discharges
Tested acc. to IEC 801-2, EN 61000-4-2 Air discharge:
Interference immunity towards transientinterference
voltage (burst)
Coupling to the power supply line of the device:
Tested acc. to IEC 801-4, prEN 61000-4-4
Interference immunity towards surge voltage
Coupling to the power supply line of the device:
Tested acc. to IEC 801-5, draft VDE 0843-5
Interference immunity towards voltage dip, brief
interruptions and voltage fluctuations
Voltage dip with 60% reduction for more than 100 ms;
angle in 45° increments
Voltage dip with 30% reduction for more than 10 ms;
angle in 45° increments
±
Voltage reduction
Tested acc. to IEC 801-11, EN 61000-4-11:
10% for more than 30 s
Contact discharge:
L - N:
L - PE:
N - PE:
No interference
No interference
No interference
8 kV
4 kV
2 kV
2 kV
4 kV
4 kV
WARNING: Always check whether sterilization
with high-pressure steam is suitable and which
temperature and sterilizing time is required to
determinate the given product.
Prior to each sterilization process it is necessary to check
whether the selected sterilization method is suitable to kill off
the germs. It is also necessary to establish whether the product
that is to be sterilized will withstand the sterilization conditions.
For instance, instruments with rubber or plastic parts can be
significantly damaged by a temperature of e.g. 143°C (3 bar).
The subsequent Table 5 can function as a guideline for the operation of an autoclave. The specified values are purely for orientation and merely relate the sterilization time to temperature
and pressure.
Table 5: Ratio between sterilization time and steam pressure and steam temperature
Sterilization time* in minutes 20 15 12 10 6 3 1
Stream pressure: bar 0,5 1,0 1,5 2,0 2,5 3,0 (4)
Stream temperature: °C 110 120 127 133 138 143 (151)
The steam temperature depends upon the steam pressure. The
temperature display is significant for sterilization, and pressure
display for the operating conditions inside the autoclave.
Interference immunity towards high-frequency radiation
Acc. to IEC 801-3, prEN 55024-3
3 V/m
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