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.