steam
sterilizer. The instructions contain important safety precautions. Make sure to keep
the Technical Manual together with the
The
instructions are part of the produc
Technical Manual
Steam sterilizer
Vacuklav®41 B+
®
Vacuklav
as of software version 3.055
43 B+
For users and service personnel
User Manual before you start operation of the
User Manual near the steam sterilizer.
t.
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
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.
®
41 B+ and Vacuklav®43
Technical Manual Vacuklav®41 B+, Vacuklav®43 B+
Responsible for the contents: MELAG Medizintechnik oHG
Technical Manual Vacuklav®41 B+ and Vacuklav®43 B+
CONTENTS
Foreword ......................................................................................................................................................... II
Installation and setting up ................................................................................................................................. 4
Removal from the packaging .......................................................................................................................... 4
Space requirements ........................................................................................................................................ 5
One way drain ................................................................................................................................................. 5
Supply with feed water .................................................................................................................................... 6
Installation material ......................................................................................................................................... 6
Program modifications .................................................................................................................................... 10
Connecting the steam sterilizer to a network .................................................................................................. 11
Verifying and changing IP addresses .............................................................................................................. 12
Connection via FTP or TCP ............................................................................................................................ 13
Precision and drift behaviour – Sensors ......................................................................................................... 16
Precision and drift behaviour – Measuring chain ........................................................................................... 16
Precision and drift after 1 year ........................................................................................................................ 16
Precision and drift after 5 years ...................................................................................................................... 16
Nominal value tolerances ................................................................................................................................ 17
Quality of the feed water ................................................................................................................................. 20
Frequently asked questions (FAQ) about the software .................................................................................. 21
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
Manufacturer:
MELAG Medizintechnik oHG
Address:
Geneststraße 6-10
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
13060:
Type B
Dr. Steffen Gebauer
According to the recommendations of the Commission for Hospital Hygiene and
Infection Prevention at the Robert-Koch Institute (Year 2012)
We herewith declare that the above designated sterilizer is suited for sterilization of
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.
Berlin, September 08, 2014
▪ Solid instruments (wrapped and unwrapped)
▪ Porous goods (wrapped and unwrapped)
▪ Hollow bodies Type A (wrapped and unwrapped)
▪ Hollow bodies Type B (wrapped and unwrapped)
▪ Helix-Test body according to DIN EN 867-5:
MELAcontrol® and MELAcontrol®PRO
(General Management)
10829 Berlin
Technical Manual Vacuklav®41 B+ and Vacuklav®43 B+
Device views
Front view
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)
Slot for the CF
Color
LED status bar
Door (opens to the left)
Cap for emergency opening of the door
Protective cap for manometer to display the pressure of
the double jacket
Power switch (concealed, accessible from the side)
Ethernet
Reset button overheating protection*
Quick
Front foot of the unit (adjustable)
*behind covering
Rear view
(12)
(13)
(14)
(15)
(16)
(17)
(18)
(19)
(20)
(21)
(22)
(23)
(24)
Tank cover
Ethernet
Ethernet
Power cable
Safety spring valve, chamber
Sterile filter
Safety
Emergency overflow
One way drain
Pressure release
Purified f
threaded fitting for hose 8x1, alternatively straight)
Rear foot of the unit (fixed)
Cooler
-touch display
-fitting connection for emptying the storage tank*
Card
steam generator
-data connection 1*
Fig. 1: Front and rear view
-data connection 2
-data connection 3* (can be retrofitted)
spring valve, double jacket
connection
eed water intake (for MELAdem; swiveling
3
Installation and setting up
Installation and setting up
Warning
Please read the User Manual of the steam sterilizer and the water
treatment unit before setting up the
Warning
If the steam sterilizer has already been put into operation, please observe
, for instance if the practice moves to
instructions and completely empty the double jacket steam generator.
damage to the steam sterilizer as well as malfunctions.
The steam sterilizer sterilizes on the basis of the fractionated vacuum. A
membrane
steam sterilizer can thus come into operation without additional installation
other than providing the power supply
important instructions concerning the
drain
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
a
▪
NOTICE!
After 5 seconds of inactivity, the display automatically switches back to the
Program
the feed water needed for the
message!
steam sterilizer.
the following before setting up again in case of any eventual transport:
■To transport the steam sterilizer
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
In order to do so, you can use the Draining program.
Failure to observe these guidelines may lead to severe burns and
pump is used to create the especially deep vacuum. The
. Please follow the following
optional connection of a one way
and general information for the proper installation which must be
ppearance 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.
s & Tests menu. The steam sterilizer then begins to suck in
4
sterilization, which triggers an error
Technical Manual Vacuklav®41 B+ and Vacuklav®43 B+
Space requirements
The space requirements for the
correspond to its dimensions plus at least 5
side
clear, in order to easily fill the s
provide sufficient ventilation.
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 incorpora
steam sterilizer
circulation is ensured.
Dimensions in brackets
For Feed water supply
In case of external feed water supply there is additional space required for
a water treatment unit MELAdem40, MELAdem47.
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
Electrical connections
Power socket
Electric circuit with 220-240 V (max. voltage range 207-253 V) and
The power socket must be accessible after installation, so that the
sterilizer can be disconnected from the power supply if necessary.
Power cable
The power cable is 1.35 m long.
Log printer MELAprint®42
If you want to connect a log printer to the steam sterilizer, you need
another socket for its power supply.
One way
Wall drain or siphon drain
A wall drain, nominal width DN 40 or a siphon drain (sink drain) is required
for the one way drain
Waste water hose
A 1 m wastewater hose (MELAG Art. No. 39180) can be ordered from
MELAG to directly connect the
pressure release goes directly into the siphon of the domestic water
supply.
One way overflow
hose to siphon
If you connect the one way overflow hose from the steam sterilizer to the
siphon of the built in water system, you need a drain hose of 2 meters (Art.
No. 36585), which
21 cm
25 (36) cm
58 (69) cm
steam sterilizer
cm on both
s and 10 cm behind. Above the tank should remain
torage tank and to
The steam sterilizer
.
ting the
; this is only possible if sufficient air
: Vacuklav®43 B+
Fig. 2: Dimensions of Vacuklav®41 B+/43 B+
Vacuklav®43 B+ weighs 66 kg without load and without feed water.
50/60 Hz
Connected load 3400 W (at least 15 A separate fuse protection)
Connected load for UK, Ireland, Malaysia 2760 W (at least 13 A
separate fuse protection)
Protection from leakage current 30 mA
steam
drain
.
steam sterilizer to the waste water, i.e. the
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 one way system
Because the steam sterilizer’s feed water becomes dirty in the process of
the water cycling, t
water one
steam generation for every sterilization. For this purpose the
sterilizer
fully
MELA
Quality of feed water
The quality of the distilled or demineralized feed water for the steam
generation must be at least
Provide the feed water from
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
one
recommend that the right chamber of the internal storage tank is then
immediately refilled.
Installation
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
(to attach to an available angle valve)
58130
Safeguard combination, consisting of return flow inhibitor and pipe aerator according to EN
1717
49600
the internal storage tank
feed water
he steam sterilizer functions according to the feed
way system. That means that it uses fresh feed water for the
steam
gets the feed water either from the internal water storage tank or
automatically from the water treatment unit MELAdem®40 or
dem47.
DIN EN 13060, Appendix C.
-up of the steam sterilizer, the steam sterilizer requires a
-time filling of 2.5 liters to fill the double jacket. We therefore
material
6
Technical Manual Vacuklav®41 B+ and Vacuklav®43 B+
Installation examples
Example 1 – Standard scope of delivery
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
connection, no other connection is needed.
A
low feed water. The program st
immediately after filling.
The
collected in the waste water chamber of
the internal storage tank and is later
drained manually. There is also a
switch for a full
(1) Tank cover
(2) Sterile filter
(3) Emergency overflow
(4) One way drain
(5) Pressure release connection
(6) Feed water inflow
(7) Power cable
(1)
(7)
(3)
(4)
(5)
(6)
(2)
power
float switch built into the device notifies
arts
used feed water (waste water) is
float
waste water chamber.
Fig. 3: Feed water supply from an internal storage tank
7
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