MELAG Vacuklav 23 B+ User manual

For users and Service personnel
Please read the accompanying User Manual before you start operation of the
autoclave. The instructions contain important safety precautions. Make sure to keep
the Technical Manual together with the User Manual near the autoclave. The
instructions are part of the product.
Technical Manual
Autoclave
Vacuklav®23 B+
Vacuklav®31 B+
as of software version 4.06

Technical Manual Vacuklav®23 B+, Vacuklav®31 B+
MELAG Medical Technology Berlin
Valid for Vacuklav®23 B+, Vacuklav®31 B+
as of software version 4.06
1st Edition October 2007
Responsible for the contents: Engineering Department
MELAG Medical Technology
Geneststraße 7-10
10829 Berlin
Germany
E-mail: [email protected]
www.melag.de
© 2007-2009 MELAG Berlin
Document: TH_2_GB_23B+_31B+.doc/Revision: 3 – 09/1528
Subject to technical changes
Foreword
This manual has been created for the autoclaves Vacuklav®23 B+ and Vacuklav®31 B+. They are identical except
for their chamber depth and device depth.
The device name "autoclave" is used to designate the steam sterilizers Vacuklav®23 B+ and Vacuklav®31 B+.
You also receive a User Manual with the autoclave. It contains important safety instructions and information which
you need to operate the autoclave. Read the User Manual completely through in proper sequence before
beginning operation with the autoclave.
This Technical Manual includes declarations of conformity, suitability statements and recommendations,
instructions for setting up, installing and initial start-up of the autoclave including installation record, extended
technical information on the software and hardware and other technical data. The Technical Manual is meant for
interested persons and service personnel.

Technical Manual Vacuklav®23 B+ and Vacuklav®31 B+
CONTENTS
Foreword ...................................................................................................................................................... II
Device views.......................................................................................................................................................... 9
Installation and setting up.................................................................................................................................. 10
Removal from the packaging...................................................................................................................... 10
Space requirements ................................................................................................................................... 10
Installation surface ..................................................................................................................................... 10
Electrical connections................................................................................................................................. 11
One-way drain............................................................................................................................................ 11
Supply with feed water ............................................................................................................................... 11
Installation material .................................................................................................................................... 11
Installation examples.................................................................................................................................. 12
Record of installation and setting up ................................................................................................................ 15
Please send to MELAG ................................................................................................................................. 15
Device and installation data ....................................................................................................................... 15
Executed work............................................................................................................................................ 16
Program modifications................................................................................................................................ 17
Electromagnetic compatibility............................................................................................................................ 18
Electromagnetic environment..................................................................................................................... 18
Recommended protective distances .......................................................................................................... 19
Technical tables................................................................................................................................................... 20
Nominal value tolerances ........................................................................................................................... 20
Pressure-Time Charts ................................................................................................................................ 20
Quality of the feed water ............................................................................................................................ 23
Brief instructions................................................................................................................................................. 24
Emergency door opening in case of power failure ..................................................................................... 24
Replace device fuses ................................................................................................................................. 25
Program overview : MAIN menu......................................................................................................................... 26
Program overview: SETUP menu: Function...................................................................................................... 27

Technical Manual Vacuklav®23 B+ and Vacuklav®31 B+
4
Declaration of conformity
Vacuklav®23 B+
In accordance with the EC-guidelines for medical devices 93/42/EWG
Manufacturer: MELAG oHG
Address: Geneststraße 9 – 10
10829 Berlin
Country: Germany
Product: Steam sterilizer (autoclave)
Type of device: Vacuklav®23 B+
Classification: Class 2a
We herewith declare that the above designated product conforms to the following
guideline:
Appendix I of the EC-guidelines for medical devices 93/42/EWG.
Notified body: DEKRA Certification Services GmbH
Handwerkstraße 15
70565 Stuttgart
No of registration: 50199-Z3-00
The cited medical device is designated with the CE sign since 25-09-2007.
Berlin, 12-03-2008
……………………………………
General Management
Quality – Made in Germany
Evidence Based Sterilization www.melag.de

Technical Manual Vacuklav®23 B+ and Vacuklav®31 B+
5
Declaration of conformity
Vacuklav®31 B+
In accordance with the EC-guidelines for medical devices 93/42/EWG
Manufacturer: MELAG oHG
Address: Geneststraße 9 – 10
10829 Berlin
Country: Germany
Product: Steam sterilizer (autoclave)
Type of device: Vacuklav®31 B+
Classification: Class 2a
We herewith declare that the above designated product conforms to the following
guideline:
Appendix I of the EC-guidelines for medical devices 93/42/EWG.
Notified body: DEKRA Certification Services GmbH
Handwerkstraße 15
70565 Stuttgart
No of registration: 50199-Z3-00
The cited medical device is designated with the CE sign since 09-08-2007.
Berlin, 12-03-2008
……………………………………
General Management
Quality – Made in Germany
Evidence Based Sterilization www.melag.de

Technical Manual Vacuklav®23 B+ and Vacuklav®31 B+
6
Declaration of conformity
Vacuklav®23 B+
Vacuklav®31 B+
Declaration of conformity according to EN 13060 for small steam sterilizers
Manufacturer: MELAG oHG
Address: Geneststraße 9 – 10
10829 Berlin
Country: Germany
Product: Steam sterilizer (autoclave)
Type of device: Vacuklav®23 B+/ Vacuklav®31 B+
Classification: Class 2a
We herewith declare that the above designated product conforms to the general
requirements set forth in the EN13060 Standard and has successfully passed the
Type tests according to EN 13060
for fulfilling requirements on a device with
“Class B” – Sterilization programs
(B-method)
Berlin, 12-03-2008
…………………………………
General Management
Quality – Made in Germany
Evidence Based Sterilization www.melag.de

Technical Manual Vacuklav®23 B+ and Vacuklav®31 B+
7
Certificate of Suitability
Vacuklav®23 B+
Vacuklav®31 B+
According to the recommendations of the Commission for Hospital Hygiene and
Infection Prevention at the Robert-Koch Institute (of April 2006)
Manufacturer: MELAG oHG
Address: Geneststraße 9 – 10
10829 Berlin
Country: Germany
Product: Steam sterilizer (autoclave)
Type of device: Vacuklav®23 B+/ Vacuklav®31 B+
Classification: Class 2a
We herewith declare, that the above designated sterilizer is suited for sterilization
of
▪Solid instruments (wrapped and unwrapped)
▪Porous goods (wrapped and unwrapped)
▪Hollow bodies-instruments Type A (wrapped and unwrapped)
▪Hollow bodies-instruments Type B (wrapped and unwrapped)
Instructions on load quantities and loading variants are set forth in the User
Manual and must be observed.
Be sure to observe the manufacturer's instructions for medical devices intended
for sterilization according to DIN ISO 17664.
Berlin, 12-03-2008
…………………………………….
General Management
Quality – Made in Germany
Evidence Based Sterilization www.melag.de

Technical Manual Vacuklav®23 B+ and Vacuklav®31 B+
8
Suitable test body
Vacuklav®23 B+
Vacuklav®31 B+
According to the recommendations of the Commission for Hospital Hygiene and
Infection Prevention at the Robert-Koch Institute (of April 2006)
Manufacturer: MELAG oHG
Address: Geneststraße 9 – 10
10829 Berlin
Country: Germany
Product: Steam sterilizer (autoclave)
Type of device: Vacuklav®23 B+/ Vacuklav®31 B+
Classification: Class 2a
We herewith declare that the following test system is suited for testing the above
cited sterilizer:
Product: Helix-Test body system according to EN 867-5
Type designation: MELAcontrol®/ PRO
Berlin, 12-03-2008
…………………………........
General Management
Quality – Made in Germany
Evidence Based Sterilization www.melag.de

Technical Manual Vacuklav®23 B+ and Vacuklav®31 B+
9
Device views
Front side
(1)
(2)
(3)
(4)
(5)
Operating and display field
Door (pivots opens to the left)
Sliding closure grip
Mains switch
Front of the unit (adjustable)
Front side below with opened door
(6) Serial data and printer connection (RS232)
(7)
(8)
(9)
(10)
Device fuses – 2x 16A/ gRl
Reset button for overheating protection
Connection for emptying the storage tank – feed water
Connection for emptying the storage tank – waste water
*hidden behind the white cover
Back side (11) Tank cap
(12)
(13)
(14)
(15)
(16)
(17)
(18)
Slot for optional upgrade with the safeguard combination
EN 1717
Sterile filter
Safety valve
One-way drain (optional)
Emergency overflow hose
Cooler
Purified feed water inlet for MELAdem®, fast screw
connection for hose 8 x1
Figure 1: Device views

Technical Manual Vacuklav®23 B+ and Vacuklav®31 B+
10
Installation and setting up
Warning!
Please read the User Manual of the autoclave and the water
treatment unit before setting up the autoclave.
The autoclave sterilizes on the basis of the fractionated pre-vacuum. A
membraneous pump is used to create the especially deep vacuum. Thus
the autoclave can be immediately put into operation without additional
installation work, apart from providing the necessary power supply. For the
optional connection of the one-way drain and an external water treatment
unit please follow the water main and general information for the proper
installation which must be observed when setting up the device.
Removal from the packaging
Unpack autoclave Lift the autoclave out of the carton with the carrying strap.
Remove carrying strap
To remove the carrying strap, unscrew the four screws on each side of the
housing. Retighten these screws firmly without the washers. Keep the
carrying strap and the washers.
After switching on After switching on the autoclave and before initial start-up, open the door
and remove the trays and the accessories from the chamber.
Space requirements
The space requirements for the autoclave
corresponds to its dimensions plus at least 5 cm on
the side and 10 cm at the back side. The autoclave
should be freely accessible from above, for easy
filling of the storage tank and to ensure proper
ventilation.
The autoclave works with a cooler located at the rear
of the device. The function and service life can be
impaired if the heat dissipation over the cooler is
restricted.
Therefore we do not recommend incorporating the
autoclave; this is only possible if sufficient air
circulation is ensured.
Dimensions of Vacuklav®23 B+/Vacuklav®31 B+
Figure 2: Dimensions Vacuklav®23 B+/ Vacuklav®31 B+
For →Feed water supply
In case of external feed water supply there is additionally required space
for the water treatment unit
MELAdem40 or MELAdem47.
Installation surface
Flat and level
Place the autoclave on a flat and level surface.
Load capacity
The Vacuklav®23 B+ weighs without load and without feed water 50 kg.
The Vacuklav®31 B+ weighs without load and without feed water 45 kg.

Installation and setting up
11
Electrical connections
Power socket 220V - 240V, 50/60Hz,
separate fuse protection 16 A, protection from leakage current 30 mA.
as of software version 4.07 2100 W for VAcuklav®23 B+/31 B+
connected load
software version 4.06 2500 W for Vacuklav®23 B+,
2400 W for Vacuklav®31 B+
Power cable The power cable is 1.35 m long.
Log printer
MELAprint®42
If you want to connect a log printer to the autoclave, you need another
socket for its power supply.
One-way drain
Wall drain o
r
siphon drain
A wall drain, nominal DN40 or a siphon drain (sink drain) is required for the
one-way drain.
Wastewater hose In order to attach the autoclave to the effluent pipe, you can order an
upgrade set (MELAG Art. No. 26695) from MELAG.
A wastewater connection is shown in Example 3 – MELAdem®47.
The drain must be located at least 30 cm beneath the autoclave and be
installed dip-free with continuous descent.
Supply with feed water
Feed water One-way-
system
Since the contamination of feed water in autoclaves using a water
circulation system regularly leads to early damages to the autoclaves and
instruments, the autoclave works in the gentle yet effective one-way water
system.
This means that it uses fresh purified feed water for every sterilization run.
For this purpose the autoclave gets the feed water either from the internal
storage tank, which the practice team has refilled e.g. with distilled water
from the MELAdest®65. Or it gets the feed water fully automatically from
the water treatment unit MELAdem®40 or MELAdem®47.
Qualit
y
of feed wate
r
The Quality of the →distilled or demineralized feed water for the steam
generation must be at least VDE 0510.
Installation material
Additional material, that can be ordered MELAG Art. No.
1 Water connection set for MELAdem®40 09033
1 Water connection set for MELAdem®47 09034
1 upgrade set for connection to the waste water via the one-way drain 26695
1 Surface-mounted siphon with double hose nozzle 37410
1 Double hose nozzle with anti-flooding flap for connection to an available siphon drain 37400
1 Water tap 3/4“ (with safeguard combination) 37310
1 Additional water tap with return flow inhibitor and pipe aerator (to attach to an available angle
valve)
58130
1 Leak monitor (water stop) with shut-off valve and probe 01056
1 feed water filtre MELAdem®48240
1 Safeguard combination, consisting of return flow inhibitor and pipe aerator according to EN
1717
48660

Technical Manual Vacuklav®23 B+ and Vacuklav®31 B+
12
Installation examples
Example 1 – Standard scope of delivery
Direct supply of →feed water from the
internal storage tank
Wastewater is collected in the
wastewater chamber of the storage
tank
No water connection necessary
Figure 3: Direct feed water supply from the internal storage tank
The autoclave is supplied with feed water
directly over a hose from the internal
storage tank. Thus no additional water
connection is required aside from the
power supply line. An integrated float-
actuated level switch in the device notifies
a lack of feed water. A program can be
started only after water is refilled.
The used feed water (wastewater) is
collected in the wastewater chamber of
the internal storage tank and later drained
off manually. A float-actuated level switch
in the wastewater chamber also notifies
that the wastewater chamber is full.
(1) Tank cap
(2) Sterile filter
(3) Safety valve
(4) One-way drain (optional)
(5) Purified feed water inlet
(6) Cooler
(7) Power cable

Installation and setting up
13
Example 2 – MELAdem®40
Supply of →feed water from the Ion
exchanger MELAdem®40
Drain via the wastewater chamberof
the internal storage tank
Connection of the ion exchanger
MELAdem40 with MELAjet®. The
simplest installation is to connect the
MELAdem40 directly to the purified feed
water inlet of the autoclave and thus
generate demineralized water from normal
tap water. The spray pistol MELAjet®is for
the final rinsing of the instruments with
demineralized water before sterilization.
Figure 4: Feed water-supply from the ion exchanger MELAdem40
(1) Autoclave back view
(2) MELAjet®(MELAG Art.-Nr. 30300 – optional)
(3) One-way drain (optional)
(4) Leak monitor (water stop) with shut-off valve and probe (MELAG Art. No. 01056 – optional),
recommended with fixed water connection
(5)
Feedwater inlet fitting for hose 6x1
(6) Water tap (available on-site)
(7) Feedwater filter MELAdem®
(8) MELAdem®40
(9) Safeguard combination, consisting of a return flow inhibitor and pipe aerator according to EN 1717 –
optional
without figure: T-piece for hose 6x1 (MELAG Art. No. 37451 – in scope of delivery)
Before you upgrade from the standard version to one with a water treatment unit, empty both chambers
of the internal storage tank!
To add on the safeguard combination EN 1717, first it is necessary to unscrew the back wall of the autoclave (1).
The water inlet hose of the EN 1717 runs under the back cover of the device. After connecting up the fixture,
remount the back cover on the device.
The device's feed water inlet fixtures (5) with 8x1 must be replaced by the feed water inlet fixtures with 6x1
(MELAG Art. No. 53461), likewise the two Cu-seals (MELAG Art. No. 42360). The water connection set contains
both components.
In this example, the used feed water (wastewater) is collected in the wastewater chamber of the storage tank. The
full wastewater chamber is manually emptied.
When the used feed water is automatically drained off over the one-way drain (see page 14, Example 3 –
MELAdem®47) the use of the leak monitor (water stop) (4) with shut-off valve and probe is recommended for
legal/insurance reasons, since the MELAdem®40 is continually under domestic water pressure.

Technical Manual Vacuklav®23 B+ and Vacuklav®31 B+
14
Example 3 – MELAdem®47
Supply of →feed water from the
reverse osmosis unit MELAdem

47
Drain via one-way drain and double-
chamber wastewater trap
Connection of the reverse osmosis unit
MELAdem®47, which can be directly
attached to the purified feed water inlet
of the autoclave. Other water treatment
units with corresponding water quality
can also be connected after consultation
with MELAG.
Figure 5: Feed water-supply from the reverse osmosis unit MELAdem47
(1) Autoclave back view
(2) One-way drain connection (included in upgrade set MELAG Art. No. 26695)
(3) Leak monitor with shut-off valve and probe (MELAG Art. No. 01056 – optional), recommended with fixed
water connection
(4)
Feed water inlet fitting for hose 6x1
(5) Waster tap (available on-site)
(6) Feedwater filter MELAdem®
(7) One-way drain hose DN15 (included in upgrade set MELAG Art. No. 26695)
(8) Inlet hose feed water
(9) MELAdem®47 with water storage container and tap for purified water
(10) Concentrate drain of MELAdem®47
(11) Double-chamber waste water trap (MELAG Art. No. 26635 – optional)
(12) Double hose nozzle with anti-flooding flap (MELAG Art. No. 37400 – optional)
(13) Safeguard combination, consisting of a return flow inhibitor and pipe aerator according to EN 1717 –
optional
Before you upgrade from the standard version to one with a water treatment unit, empty both chambers
of the internal storage tank!
To add on the safeguard combination EN 1717, first it is necessary to unscrew the back wall of the autoclave (1).
The water inlet hose of the EN 1717 runs under the back cover of the device. After connecting up the fitting,
remount the back cover on the device.
The device's feed water inlet fittings (4) with 8x1 must be replaced by the feed water inlet fittings with 6x1
(MELAG Art. No. 53461), likewise the two Cu-seals (MELAG Art. No. 42360). The water connection set contains
both components.
In this example the wastewater draining is also automated. The waste water is collected in the water storage tank
(waste water side) and flows through the one-way outflow hose (7) off. The one-way outflow hose is connected
with the siphon via the double hoze nozzle (12). The use of the leak monitor (3) with shut-off valve and probe is
recommended for legal/insurance reasons, since the MELAdem®47 is continually under domestic water pressure.

Fax [phone] Tel. [phone]
15
Record of installation and setting up
Please send to MELAG
Dear Madam/Sir,
MELAG Medical Technology
Geneststraße 7 – 10
10829 Berlin
within the scope of Quality Assurance we are
obligated, in cooperation with you, the responsible
specialist MELAG dealer, to install this MELAG
autoclave at the operator's in accordance with good
engineering practice and provide instructions in its
use.
Please copy, fill out and sign this form and send it to
us after the autoclave has been successfully
installed.
The returned form is prerequisite for the
MELAG factory warranty.
Device and installation data
We, hereinafter referred to as specialist MELAG dealer, have today installed, instructed the personnel
and performed the initial start-up of the autoclave Vacuklav®23 B+/31 B+ as described below:
Specialist dealer (name, address, stamp)
………………………………………………………………
Operator (name, address/ stamp)
………………………………………………………………
E-mail-address for software update
………………………………………………………………
E-mail-address for software update
………………………………………………………………
Serial No. Vacuklav®23 B+/31 B+
………………………………………………………………
Remarks
………………………………………………………………
Please place checkmark where applicable:
O First installation O Subsequent
installation
Date
………………………………………………………………
The following persons were present during the instructions for use:
Name, first name (please print in block letters) Signature
From the practice/ clinic: …………………………………………………………… ……………………………………..
…………………………………………………………... …………………………………….
…………………………………………………………… ……………………………………..
…………………………………………………………… ……………………………………..
Name, first name (please print in block letters) Signature
Instructing technician: …………………………………………………………… ……………………………………..
From the company: …………………………………………………………… ……………………………………..

Record of installation and setting up
16
Executed work
Please confirm the respective points with a checkmark after completion of the described task.
Secure feed water supply (depending on installation variant)
O Right feed water chamber of the internal storage tank filled up with feed water
O Water treatment unit MELAdem®40 or MELAdem®47 set up according to installation instructions
O In case of installing a water treatment unit : Autoclave was set in the user menu on „feed water-supply –
extern“
O It was pointed out that demineralized water with a minimum quality according to VDE 0510 must be used as
feed water, and the items to be sterilized must be clean and free of cleanser and disinfectant residues
Install wastewater connection (depending on installation variant)
O Wastewater is collected in the internal storage tank (no wastewater connection)
O One-way drain connected to the existing siphon of the domestic water supply or the double-chamber
wastewater trap from MELAG
Align the autoclave
For fault-free operation, the autoclave must be set up horizontally with the help of a water level located close to the
sterilization-chamber flange. Then depending on the type of autoclave, the front feet of the unit must be unscrewed
by about three or five rotations in order to give the autoclave a slight backwards tilt.
O Vacuklav®23 B+: front feet of the unit screwed out 5 rotations
O Vacuklav®31 B+: front feet of the unit screwed out 3 rotations
Conduct and record vacuum test with empty chamber and Universal-Program with 1.5 kg load
(instruments)
O Vacuumtest performed with empty cold chamber. Leakage rate: ……………..mbar/min.
O Universal-Program successfully executed with about 1.5 kg load (instruments)
O A printout of the program cycle was created with
the log printer MELAprint®42 and pasted into lower
fields provided for this purpose
O No printer available – leakage rate and successful
run of the Universal-Program were recorded in the
fields provided for this purpose
Check the time setting, if necessary reset the time according to instructions in the User Manual
O Time is correct or correctly reset
Reset service meter according to separate instructions
O Service meter is reset O Service meter is not reset
Instructing the operating personnel and handing over the technical documentation
O Operating personnel were instructed
O User Manual was handed over O Technical Manual was handed over
O Chamber certificate was handed over
O MDD Certificate of Conformity was handed over
O Warranty Certificate was handed over
The device was properly installed by the above named technician
O without fault
O with fault: ……………………………………………………………………………………………..
Logs Vacuumtest Universal-Program
Please paste and fold up logs here; if
no printer is available, then enter
leakage rate and successful
completion of the Universal-Program

Technical Manual Vacuklav®23 B+ and Vacuklav®31 B+
17
Program modifications
The autoclave program cycles correspond to the practice-relevant
requirements of fractionation, heating up, sterilization, pressure discharge,
drying and ventilation with their parameters of pressure, temperature and
time.
The standard functions of preheating and additional drying provide two
options for influencing the program cycle.
Further changes to the program cycles are possible in individual cases and
within the scope of the guaranteed sterilization efficiency, but can only be
executed by authorised persons. Please consult your specialist dealer or
contact MELAG.

Technical Manual Vacuklav®23 B+ and Vacuklav®31 B+
18
Electromagnetic compatibility
Electromagnetic environment
Warning!
The autoclave is designed for operation in an environment as described
below. The customer or user must ensure that the autoclave is operated in
such an environment as here described.
The abbreviation HF is used for high frequency in the following tables.
Emitted interference
measurements
Compliance Electromagnetic environment guideline
HF emissions
as per CISPR 11
Group 1 The autoclave uses HF energy exclusively for its
internal function. Consequently, its HF emission is
very slight, and it is unlikely that adjacent
electronic instruments might be disturbed.
HF emissions
as per CISPR 11
Class B
Emissions of harmonics
as per IEC 61000-3-2
Class A
Emissions of voltage fluctuations / flickers
as per IEC 61000-3-3
complies
The autoclave is suited for use in all facilities
including those containing living areas and those
which are directly connected to a public supply
system which likewise serves residential buildings.
Interference
immunity tests
IEC 60601
test level
Compliance level Electromagnetic environment guideline
Electrostatic
discharge (ESD)
as per
IEC 61000-4-2
±6kV contact discharge
±8kV air discharge
±6kV contact discharge
±8kV air discharge
Floors should be made of wood or concrete or laid
with ceramic tiles. If the flooring is furnished with
synthetic material, the relative humidity must be at
least 30%.
Rapid transient
electrical
disturbances/
bursts as per
IEC 61000-4-4
±2kV for mains cables
±1kV for input and output
cables
±2kV for mains cables
±1kV for input and output
cables
The quality of the supply voltage should
correspond to a typical business or hospital
environment.
Surges as per
IEC 61000-4-5
±1kV push-pull voltage
±2kV common-mode
voltage
±1kV push-pull voltage
±2kV common-mode
voltage
The quality of the supply voltage should
correspond to a typical business or hospital
environment.
Voltage drops,
short-term
interruptions and
fluctuations of the
supply voltage as
per
IEC 61000-4-11
<5% UT* (5% sag of the
UT) for ½ period
<40% UT* (60% sag of the
UT) for 5 periods
<70% UT* (30% sag of the
UT) for 25 periods
<5% UT* (95% sag of the
UT) for 5 s
<5% UT* (95% sag of the
UT) for ½ period
<40% UT* (60% sag of the
UT) for 5 periods
<70% UT* (30% sag of the
UT) for 25 periods
<5% UT* (95% sag of the
UT) for 5 s
The quality of the supply voltage should
correspond to a typical business or hospital
environment.
If the autoclave user demands continual
functioning of the device even when there are
interruptions in the energy supply, we recommend
supplying the autoclave from an interruption-free
power supply or a battery.
Magnetic fields
with the supply
frequency (50Hz)
as per
IEC 61000-4-8
3 A/m 3 A/m Magnetic fields with the mains frequency should
correspond to the typical values found in the
business and hospital environment.
* UTis the ac mains supply before the application of the test level

Electromagnetic compatibility
19
Interference
immunity tests
IEC 60601
test level
Compliance level Electromagnetic environment guideline*1
conducted HF
disturbances as
per IEC 61000-4-6
radiated HF
disturbances as
per IEC 61000-4-3
3 Veff
150 kHz to 80 MHz
3 V/m
80 MHz to 2.5 GHz
3 Veff
3 V/m
Portable and mobile radio equipment should not be
placed closer to the autoclave (including hoses and
pipes) than the recommended protective distance
calculated according to the formula for the transmitting
frequency.
(see table below: Recommended protective
distances)
The field intensity of stationary radio transmitters should
be less than the compliance level for all frequencies
according to an on-site*2 investigation*3.
Disturbances are possible in the environment of
devices bearing this symbol.
*1 This guideline might not be applicable in all cases. The dispersion of electromagnetic magnitudes is influenced by the
absorption and reflection of buildings, objects and people.
*2 The field intensity of stationary transmitters, such as e.g. base stations of radio telephones and mobile land radio devices,
amateur radio stations, AM and FM radio broadcasting and TV transmitters are not able to be exactly theoretically determined
beforehand. You should consider conducting a study of the location to determine the electromagnetic environment with respect
to the stationary transmitters. If the measured field intensity at the location where the autoclave is to be used exceeds the
above compliance level, then observe the autoclave carefully to verify its proper functioning. If unusual performance
characteristics are observed, additional measures might be required, such as for instance modifying the alignment or finding
another location for the autoclave.
3Within the frequency range of 150 kHz to 80 MHz, the field intensity should be less than 3 V/m.
Recommended protective distances
Between portable an
d
mobile H
F
telecommunication
devices and the autoclave
The autoclave is designed for operation in an electromagnetic
environment in which the HF disturbances are monitored. The customer or
the user of the autoclave can thus help to avoid electromagnetic
disturbances by complying with the minimum distance required between
portable and mobile HF telecommunication devices (transmitters) and the
autoclave, depending on the power output of the communication device,
as stated below.
For transmitters whose maximum nominal power is not specified in the
following table, the recommended protective distance d in meters (m) can
be determined by using the equation in the respective column, whereby P
is the maximum nominal power of the transmitter in watt (W) according to
the specifications of the transmitter manufacturer.
Protective distance depending on the transmitting frequency [m]
150 kHz to 80 MHz 80 MHz to 800 MHz*800 MHz to 2.5 GHz*
Pd 2.1Pd 2.1Pd 3.2
Nominal power of the transmitter
[W]
d… recommended protective distance in meters
P… maximum nominal power of the transmitter in watt according to information of
the transmitter manufacturer
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
*For 80 MHz and 800 MHz the higher frequency range applies

Technical Manual Vacuklav®23 B+ and Vacuklav®31 B+
20
Technical tables
Nominal value tolerances
Step Press. P Tolerance P Tol. Tol. P Tol. P Tol.
80 + 50/- 20 ◄◄◄◄ ◄ ◄150 ◄Evacuate
1400 + 50/- 30 ◄◄◄◄ ◄ ◄ ◄ ◄ Steam entry
180 + 50/- 20 ◄◄◄◄ ◄ ◄250 ◄Evacuate
1400 + 50/- 30 ◄◄◄◄ ◄ ◄ ◄ ◄ Steam entry
180 + 50/- 20 ◄◄◄◄ ◄ ◄--- --- Evacuate
1400 + 50/- 30 ◄◄◄◄ ◄ ◄--- --- Steam entry
3050 + 70/- 30 ◄◄◄◄2060 ◄◄◄ Heat up
3050 + 70/- 30 ◄◄◄◄2060 ◄◄◄
Sterilization start
3160 + 90/- 90 ◄◄◄◄2150 ◄◄◄ Sterilization
1200 + 30/- 90 ◄◄◄◄ ◄ ◄ ◄ ◄
Pressure release
Prion-Pr. Gentle-Pr. Quick S ◄
means as in Universal- Pr
All values in mbar
1. F.
Fractionation
2. F.
3. F.
Universal-Pr. Quick B
Pressure-Time Charts
Figure 6: Pressure-Time chart for Universal-Program, 134 °C and 2.1 bar