Technical Manual
Steam sterilizer
Vacuklav®41 B+
Vacuklav®43 B+
as of software version 3.055
For users and service personnel
Please read the accompanying User Manual before you start operation of the steam sterilizer. The instructions contain important safety precautions. Make sure to keep the Technical Manual together with the User Manual near the steam sterilizer. The instructions are part of the product.
Foreword
This manual has been created for the steam sterilizers Vacuklav®41 B+ and Vacuklav®43 B+. They are identical except for their chamber depth and device depth.
The device name "steam sterilizer" is used to designate the steam sterilizers Vacuklav®41 B+ and Vacuklav®43 B+.
You also receive a User Manual with the steam sterilizer. It contains important safety instructions and information which you need to operate the steam sterilizer. Read the User Manual completely through in proper sequence before beginning operation with the steam sterilizer.
This Technical Manual among other things includes suitability statements and recommendations, instructions for setting up, installing and initial start-up of the steam sterilizer, 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®41 B+, Vacuklav®43 B+
Responsible for the contents: MELAG Medizintechnik oHG
MELAG Medizintechnik oHG
Geneststraße 6-10
10829 Berlin
Germany
E-Mail: info@melag.de www.melag.de
Document: TH_EN_41B+_43B+_v6.docx/Revision: 6 – 15/1362 Alteration date: 23-07-2015
Subject to technical changes
Technical Manual Vacuklav®41 B+ and Vacuklav®43 B+
CONTENTS |
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Foreword......................................................................................................................................................... |
II |
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............................................................................................................................................................................. |
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2 |
Device views ....................................................................................................................................................... |
3 |
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Installation and setting up ................................................................................................................................. |
4 |
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Removal from the packaging .......................................................................................................................... |
4 |
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Space requirements........................................................................................................................................ |
5 |
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Installation surface.......................................................................................................................................... |
5 |
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Electrical connections ..................................................................................................................................... |
5 |
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One way drain................................................................................................................................................. |
5 |
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Supply with feed water.................................................................................................................................... |
6 |
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Installation material ......................................................................................................................................... |
6 |
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Installation examples ...................................................................................................................................... |
7 |
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Display settings............................................................................................................................................... |
10 |
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Counter readings ............................................................................................................................................ |
10 |
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Program modifications .................................................................................................................................... |
10 |
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Connecting the steam sterilizer to a network .................................................................................................. |
11 |
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Verifying and changing IP addresses.............................................................................................................. |
12 |
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Connection via FTP or TCP ............................................................................................................................ |
13 |
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Electromagnetic compatibility........................................................................................................................... |
14 |
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Electromagnetic environment.......................................................................................................................... |
14 |
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Recommended protective distances ............................................................................................................... |
15 |
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Technical tables.................................................................................................................................................. |
16 |
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Precision and drift behaviour – Sensors ......................................................................................................... |
16 |
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Precision and drift behaviour – Measuring chain ........................................................................................... |
16 |
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Precision and drift after 1 year ........................................................................................................................ |
16 |
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Precision and drift after 5 years ...................................................................................................................... |
16 |
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Nominal value tolerances................................................................................................................................ |
17 |
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Pressure-Time Charts..................................................................................................................................... |
18 |
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Quality of the feed water ................................................................................................................................. |
20 |
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Frequently asked questions (FAQ) about the software .................................................................................. |
21 |
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1 |
How can I open and print a log file? ....................................................................................................... |
21 |
2 |
What do the numerals and letters in the directories and log file name mean? ....................................... |
22 |
3 |
How can I format a CF card at the steam sterilizer itself? ...................................................................... |
22 |
4 |
How is a CF card formatted at the PC so that it is recognized by the steam sterilizer?.......................... |
23 |
5 |
What do the terms DHCP, IP address and subnetwork mean?.............................................................. |
23 |
6 |
How do I ascertain the IP address and network settings of a PC?......................................................... |
24 |
7 |
How do I register the steam sterilizer as a user with MELAG FTP server? ............................................ |
24 |
8 |
How can I verify the version of the steam sterilizer software?................................................................ |
25 |
Certificate of Suitability
According to the recommendations of the Commission for Hospital Hygiene and Infection Prevention at the Robert-Koch Institute (Year 2012)
Manufacturer: |
MELAG Medizintechnik oHG |
Address: |
Geneststraße 6-10 |
|
10829 Berlin |
Country: |
Germany |
Product: |
Vacuklav®41 B+/Vacuklav®43 B+ |
Type of device: |
Steam sterilizer (steam sterilizer) |
Classification: |
Class 2b |
Device type acc. to DIN EN |
Type B |
13060: |
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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 Type A (wrapped and unwrapped)
▪Hollow bodies 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 EN ISO 17664.
We herewith declare that the following test system is suited for testing the above cited steam sterilizer.
▪Helix-Test body according to DIN EN 867-5: MELAcontrol® and MELAcontrol®PRO
Berlin, September 08, 2014
Dr. Steffen Gebauer
(General Management)
Technical Manual Vacuklav®41 B+ and Vacuklav®43 B+
Device views
Front view
(1) |
Slot for the CF Card |
(2) |
Color-touch display |
(3) |
LED status bar |
(4)Door (opens to the left)
(5) Cap for emergency opening of the door
(6) Protective cap for manometer to display the pressure of the double jacket steam generator
(7) Power switch (concealed, accessible from the side)
(8) Ethernet-data connection 1*
(9)Reset button overheating protection*
(10)Quick-fitting connection for emptying the storage tank*
(11)Front foot of the unit (adjustable) *behind covering
Rear view
(12) Tank cover
(13) |
Ethernet-data connection 2 |
(14) |
Ethernet-data connection 3* (can be retrofitted) |
(15) |
Power cable |
(16) |
Safety spring valve, chamber |
(17) |
Sterile filter |
(18) |
Safety spring valve, double jacket |
(19) |
Emergency overflow |
(20) |
One way drain |
(21) |
Pressure release connection |
(22) |
Purified feed water intake (for MELAdem; swiveling |
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threaded fitting for hose 8x1, alternatively straight) |
(23) Rear foot of the unit (fixed)
(24) Cooler
Fig. 1: Front and rear view
3
Installation and setting up
Installation and setting up
Warning
Warning
Please read the User Manual of the steam sterilizer and the water treatment unit before setting up the steam sterilizer.
If the steam sterilizer has already been put into operation, please observe the following before setting up again in case of any eventual transport:
■To transport the steam sterilizer, for instance if the practice moves to a new location, wait until the pressure indicator on the manometer display shows null bar after the steam sterilizer is switched off. Be sure to check the pressure indicator on the manometer before moving the steam sterilizer
■To transport the unit over longer distances, an authorised person must prepare the steam sterilizer beforehand according to
instructions and completely empty the double jacket steam generator. In order to do so, you can use the Draining program.
Failure to observe these guidelines may lead to severe burns and damage to the steam sterilizer as well as malfunctions.
The steam sterilizer sterilizes on the basis of the fractionated vacuum. A membrane pump is used to create the especially deep vacuum. The steam sterilizer can thus come into operation without additional installation other than providing the power supply. Please follow the following important instructions concerning the optional connection of a one way drain and general information for the proper installation which must be observed when setting up the device.
Removal from the packaging
Unpack steam sterilizer Lift the steam sterilizer 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 steam sterilizer and before initial start-up, open the door and remove the trays and the accessories from the chamber.
To do this you must go into door mode as below, immediately following the
appearance of the start screen “Welcome”:
▪ At the start screen image Welcome, press and hold the second button from the right in the action bar until the display changes to the
next window. After, the door can be opened by pressing the 
symbol.
NOTICE!
After 5 seconds of inactivity, the display automatically switches back to the Programs & Tests menu. The steam sterilizer then begins to suck in
the feed water needed for the sterilization, which triggers an error message!
4
Technical Manual Vacuklav®41 B+ and Vacuklav®43 B+
Space requirements
25 (36) cm |
21 cm |
58 (69) cm |
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The space requirements for the steam sterilizer correspond to its dimensions plus at least 5 cm on both sides and 10 cm behind. Above the tank should remain clear, in order to easily fill the storage tank and to provide sufficient ventilation. The steam sterilizer uses a cooling system that has a cooler at the rear of the device.
The function and lifetime can be affected if heat dissipation via the cooler is restricted.
Therefore we do not recommend incorporating the steam sterilizer; this is only possible if sufficient air circulation is ensured.
Dimensions in brackets: Vacuklav®43 B+
Fig. 2: Dimensions of Vacuklav®41 B+/43 B+
For Feed water supply In case of external feed water supply there is additional space required for a water treatment unit MELAdem 40, MELAdem 47.
Installation surface
Flat and level Place the steam sterilizer on a flat and level surface.
Load capacity The Vacuklav®41 B+ weighs 59 kg without load and without feed water.
The Vacuklav®43 B+ weighs 66 kg without load and without feed water.
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Electrical connections |
Power socket |
Electric circuit with 220-240 V (max. voltage range 207-253 V) and |
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50/60 Hz |
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Connected load 3400 W (at least 15 A separate fuse protection) |
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Connected load for UK, Ireland, Malaysia 2760 W (at least 13 A |
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separate fuse protection) |
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Protection from leakage current 30 mA |
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The power socket must be accessible after installation, so that the steam |
Power cable |
sterilizer can be disconnected from the power supply if necessary. |
The power cable is 1.35 m long. |
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Log printer MELAprint®42 |
If you want to connect a log printer to the steam sterilizer, you need |
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another socket for its power supply. |
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One way drain |
Wall drain or siphon drain |
A wall drain, nominal width DN 40 or a siphon drain (sink drain) is required |
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for the one way drain. |
Waste water hose |
A 1 m wastewater hose (MELAG Art. No. 39180) can be ordered from |
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MELAG to directly connect the steam sterilizer to the waste water, i.e. the |
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pressure release goes directly into the siphon of the domestic water |
One way overflow |
supply. |
If you connect the one way overflow hose from the steam sterilizer to the |
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hose to siphon |
siphon of the built in water system, you need a drain hose of 2 meters (Art. |
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No. 36585), which you can also request from MELAG. |
5
Installation and setting up
The drain must be located at least 30 cm beneath the steam sterilizer and be installed dip-free with continuous descent.
Supply with feed water
Feed water one way system Because the steam sterilizer’s feed water becomes dirty in the process of the water cycling, the steam sterilizer functions according to the feed water one way system. That means that it uses fresh feed water for the steam generation for every sterilization. For this purpose the steam sterilizer gets the feed water either from the internal water storage tank or fully automatically from the water treatment unit MELAdem®40 or MELAdem 47.
Quality of feed water The quality of the distilled or demineralized feed water for the steam generation must be at least DIN EN 13060, Appendix C.
Provide the feed water from the internal storage tank
Before the initial start-up of the steam sterilizer, the right chamber of the internal storage tank must be filled with feed water up to the maximum mark.
At the initial start-up of the steam sterilizer, the steam sterilizer requires a one-time filling of 2.5 liters to fill the double jacket. We therefore recommend that the right chamber of the internal storage tank is then immediately refilled.
Installation material
Additional material, that can be ordered |
MELAG Art. No. |
Water connection set MELAdem®40 |
09033 |
Water connection set MELAdem®47 |
09034 |
Water connection set consisting of (contained in Art. No. 09033 and 09034): |
25655 |
Feed water inflow nozzle for 6x1 hose (substitute nozzle for 8x1) |
21140 |
Hollow screw for feed water inflow nozzle |
53430 |
2x Cu seals 1/8“ for Art. No. 53461 |
42360 |
2x Cu seals 1/4“ for Art. No.53471 (for twisting, substitute Art. No. 53471) |
36060 |
Pressure release nozzle (1/4“ – quick connect for 8x1 hose (twist onto the device) |
53471 |
One way drain hose PTFE-pipe 8/6 – cut to size |
39180 |
One way drain hose (overflow hose, 2 m) |
36585 |
Surface mounted siphon with double hose nozzle |
37410 |
Double hose nozzle with anti-flooding flap for connection to existing sink siphon |
37400 |
Water tap 3/4“ (safeguard combination) |
37310 |
Additional water tap with return flow inhibitor and pipe aerator |
58130 |
(to attach to an available angle valve) |
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Safeguard combination, consisting of return flow inhibitor and pipe aerator according to EN |
49600 |
1717 |
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6
Technical Manual Vacuklav®41 B+ and Vacuklav®43 B+
Installation examples
Example 1 – Standard scope of delivery
(1)
(2)
(7)
(3)
(4)
(5)
(6)
Supply of the feed water is from an internal supply tank
Waste water is collected in the waste water chamber of the storage tank
No water connection is required
The steam sterilizer is supplied with feed water directly via a hose from the internal storage tank. Thus, other than power connection, no other connection is needed. A float switch built into the device notifies low feed water. The program starts immediately after filling.
The used feed water (waste water) is collected in the waste water chamber of the internal storage tank and is later drained manually. There is also a float switch for a full waste water chamber.
Fig. 3: Feed water supply from an internal storage tank
(1)Tank cover
(2)Sterile filter
(3)Emergency overflow
(4)One way drain
(5)Pressure release connection
(6)Feed water inflow
(7)Power cable
7
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