MELAG Vacuklav 41-B User manual

Technical Manual
Autoclave
Vacuklav®41-B
Vacuklav®43-B
For Users and Service personnel
Please read the accompanying User Manual before you start operation of the auto-
clave. 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.

Foreword
This manual has been created for the autoclaves Vacuklav®1-B and Vacuklav®3-B. They are identical except
for their chamber depth and device depth.
The device name "autoclave" is used to designate the steam sterilizers Vacuklav®1-B and Vacuklav®3-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, instruc-
tions 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 inter-
ested persons and service personnel.
Technical Manual Vacuklav®41-B Vacuklav®43-B
MELAG Medical Technology Berlin
Valid for Vacuklav®1-B, Vacuklav®3-B
as of software version 2. x
1st Edition February 2008
Responsible for the contents: Engineering Department
MELAG Medical Technology
Geneststraße 7-10
10829 Berlin
Germany
E-Mail: [email protected]
www.melag.de
© 2008-2009 MELAG Berlin
Document: Melag_Vacuklav_ 1B_ 3B_TechnicalManual_v3.doc/Revision: 3 – 09/1793
Subject to technical changes

Technical Manual Vacuklav®1-B and Vacuklav® 3-B
CONTENTS
Foreword.......................................................................................................................................................... 2
Device views......................................................................................................................................................... 8
Device views Flex-Display...................................................................................................................................9
Installation and setting up................................................................................................................................... 10
Removal from the packaging............................................................................................................................ 10
Space requirements.........................................................................................................................................11
Installation surface............................................................................................................................................ 11
Electrical connection......................................................................................................................................... 11
One-way drain..................................................................................................................................................11
Supply with → feed water.................................................................................................................................12
Installation material........................................................................................................................................... 12
Installation examples........................................................................................................................................13
Record of installation and setting up.................................................................................................................16
Please send to MELAG....................................................................................................................................16
Device and installation data.............................................................................................................................. 16
Executed work..................................................................................................................................................17
Contrast setting................................................................................................................................................19
Counter readings.............................................................................................................................................. 19
Program modifications...................................................................................................................................... 19
Electromagnetic compatibility............................................................................................................................20
Electromagnetic environment...........................................................................................................................20
Recommended protective distances................................................................................................................21
Technical tables................................................................................................................................................... 22
Precision and drift behaviour – Sensors .......................................................................................................... 22
Precision and drift behaviour –
Measuring chain...............................................................................................................................................22
Precision and drift after 1 year.......................................................................................................................... 22
Precision and drift after 5 years........................................................................................................................22
Nominal value tolerances.................................................................................................................................23
Pressure-Time-Charts......................................................................................................................................2
Quality of the → feed water..............................................................................................................................26
Frequently asked questions (FAQ) about the software....................................................................................27
Checklist for software update.............................................................................................................................42

Technical Manual Vacuklav®1-B and Vacuklav®3-B
Konformitätserklärung im Sinne der EG Richtlinie über Medizinprodukte 93/ 2/EWG
Declaration of conformity
Vacuklav®41-B
Vacuklav®43-B
In accordance with the EC- guidelines for medical devices 93/ 2/EWG
Manufacturer: MELAG oHG
Address: Geneststraße 9 – 10
10829 Berlin
Country: Germany
Product: Steam sterilizer (autoclave)
Type of device: Vacuklav®1-B/Vacuklav®3-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-Z2-00
The cited medical device is designated with the CE sign since 25-06-200 .
Berlin, 12-03-2008
..............................................
General Management
Quality – Made in Germany
Evidence Based Sterilization www.melag.de
2

Technical Manual Vacuklav®1-B and Vacuklav®3-B
Konformitätserklärung im Sinne der EN 13060 für Dampf-Klein-Sterilisatoren („Bescheinigung“)
Declaration of conformity
Vacuklav®41-B
Vacuklav®43-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®1-B/Vacuklav®3-B
Classification: Class 2a
We herewith declare that the above designated product conforms to the general re-
quirements 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 program
(B-method)
Berlin, 12-03-2008
..............................................
General Management
Quality – Made in Germany
Evidence Based Sterilization www.melag.de
3

Technical Manual Vacuklav®1-B and Vacuklav®3-B
Eignungsbeleg nach den Empfehlungen der KHI am RKI (vom April 2006)
Certificate of Suitability
Vacuklav®41-B
Vacuklav®43-B
According to the recommendations of the Commission for Hospital Hygiene and In-
fection 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®1-B/ Vacuklav®3-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 un-
wrapped)
▪Hollow bodies-instruments Type B (wrapped and un-
wrapped)
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 1766 .
Berlin, 12-03-2008
..............................................
General Management
Quality – Made in Germany
4

Technical Manual Vacuklav®1-B and Vacuklav®3-B
Evidence Based Sterilization www.melag.de
5

Technical Manual Vacuklav®1-B und Vacuklav®3-B
Geeigneter Prüfkörper nach den Empfehlungen der KHI am RKI (vom April 2006)
Suitable test body
Vacuklav®41-B
Vacuklav®43-B
According to the recommendations of the Commission for Hospital Hygiene and In-
fection 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®1-B/Vacuklav®3-B
Classification: Class 2a
We herewith declare that the following test system is suited for testing the above
cited sterilizer:
Product: Helix-Test body according to EN 867-5
Type designation: MELAcontrol®
Berlin, 12-03-2008
..............................................
General Management
Quality – Made in Germany
Evidence Based Sterilization www.melag.de
6

Technical Manual Vacuklav®1-B and Vacuklav® 3-B
Device views
Front side
(1)
(2)
(3)
( )
(5)
(7)
(8)
(9)
(10)
Protective cap for slot of the →CF card
Control panel
Door (pivot opens to the left)
Protective cap for manometer to display the pressure of
the →double jacket steam-generator
Cap for emergency opening of the door
Mains switch (concealed, accessible from the side)
Ethernet-1-Data connection*
Reset button overheating protection*
Front foot of the unit (adjustable)
*behind covering
Back side
(11)
(12)
(13)
(1 )
(15)
(16)
(17)
(18)
(19)
(20)
(21)
(22)
(23)
Tank filler cap
Ethernet-2 data connection
Ethernet-3 data connection (can be retrofitted)
Power cable
Safety valve chamber
Sterile filter
Safety valve double jacket
Emergency overflow
One-way drain
Connection pressure discharge
Purified feed water inlet (for MELAdem®, swivelling
threaded fitting for hose ∅8x1, alternatively straight)
Back foot of the unit
Cooler
Fig. 1:Front- and rear view
7

Technical Manual Vacuklav®1-B und Vacuklav®3-B
Device views Flex-Display
Front side
(1)
(2)
(3)
( )
(5)
(6)
(7)
(8)
(9)
(10)
Protective cap for slot of the →CF card
Control panel
Door (pivot opens to the left)
Protective cap for manometer to display the pressure of
the →double jacket steam-generator
Cap for emergency opening of the door
Mains switch (concealed, accessible from the side)
Ethernet-1-Data connection*
Reset button overheating protection*
Front foot of the unit (adjustable)
*behind covering
Back side
(11)
(12)
(13)
(1 )
(15)
(16)
(17)
(18)
(19)
(20)
(21)
(22)
(23)
(2 )
Tank filler cap
Ethernet-2 data connection
Ethernet-3 data connection (can be retrofitted)
Power cable
Safety valve chamber
Sterile filter
Safety valve double jacket
Emergency overflow
One-way drain
Connection pressure discharge
Purified feed water inlet (for MELAdem®, swivelling
threaded fitting for hose ∅8x1, alternatively straight)
Back foot of the unit
Cooler
8