Technical Manual: Euroklav 23 VS+ Euroklav 29 VS+
Technical Manual: Euroklav 23 VS+ Euroklav 29 VS+
Technical Manual: Euroklav 23 VS+ Euroklav 29 VS+
Autoclave
Euroklav23 VS+
Euroklav29 VS+
as of software version V4.06
Foreword
This manual has been created for the autoclaves Vacuklav 23 VS+ and Vacuklav 29 VS+. They are identical
except for their chamber depth and device depth.
The device name "autoclave" is used to designate the steam sterilizers Vacuklav 23 VS+ and Vacuklav 29 VS+.
You also receive a Technical Description with the autoclave. It contains important safety instructions and
information which you need to operate the autoclave. Read the Technical Description 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.
CONTENTS
Foreword ...................................................................................................................................................... II
Declaration of conformity according to the EC-guide lines for medical devices 93/42/EWG ......................... 4
Device views .......................................................................................................................................................... 5
Installation and setting up .................................................................................................................................... 6
Removal from the packaging........................................................................................................................ 6
Space requirements ..................................................................................................................................... 6
Installation surface ....................................................................................................................................... 6
Electrical connections................................................................................................................................... 7
One-way drain .............................................................................................................................................. 7
Supply with feed water ................................................................................................................................. 7
Installation material ...................................................................................................................................... 7
Installation examples.................................................................................................................................... 8
Record of installation and setting up ................................................................................................................ 12
Device and installation data ....................................................................................................................... 12
Executed work............................................................................................................................................ 13
Program modifications................................................................................................................................ 14
Electromagnetic compatibility............................................................................................................................ 15
Electromagnetic environment ..................................................................................................................... 15
Recommended protective distances .......................................................................................................... 16
Technical tables................................................................................................................................................... 17
Nominal value tolerances ........................................................................................................................... 17
Pressure-Time-Charts ................................................................................................................................ 17
Quality of the feed water ............................................................................................................................ 19
Brief instructions................................................................................................................................................. 20
Emergency door opening in case of power failure ..................................................................................... 20
Replace device fuses ................................................................................................................................. 21
Program overview : MAIN menu......................................................................................................................... 22
Program overview: SETUP menu: Function...................................................................................................... 23
Declaration of conformity according to the EC-guide lines for medical devices 93/42/EWG
Declaration of conformity
Euroklav23 VS+
Euroklav29 VS+
In accordance with the EC-guidelines for medical devices 93/42/EWG
Manufacturer:
Address:
Country:
Product:
Type of classification:
Classification:
MELAG oHG
Geneststrae 9 10
10829 Berlin
Germany
Steam sterilizer (autoclave)
Euroklav23 VS+/ Euroklav29 VS+
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:
No. of registration:
50199-Z3-00
The cited medical device is designated with the CE sign since 19-10-2007.
Berlin, 19-10-2007
General Management
www.melag.de
Device views
Front side
(1) Tank cap
(2) Operating and display field
Back side
After switching on
Lift the autoclave out of the carton with the 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 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 10 cm on
both sides.
The autoclave should be freely accessible from
above, or easy filling of the storage tank and to
ensure proper ventilation.
The autoclave is not suitable for incorporation
into existing furnishings.
Installation surface
Flat and level
Load capacity
The Euroklav 29 VS+ weighs without load and without feed water 42 kg
Electrical connections
Power socket
connected load
Power cable
Log printer
MELAprint42
One-way drain
Wall drain or
siphon drain
Wastewater hose
A wall drain, nominal DN40 or a siphon drain (sink drain) is required for the
one-way drain.
A wastewater hose with a length of 2 metres (MELAG Art. No. 36585) can
be ordered from MELAG to connect the autoclave to the waste water.
The drain must be located at least 30 cm beneath the autoclave and be
installed dip-free with continuous descent.
Quality of
feed water
The autoclave works both according to the feed water one-way system as
well as the feed water circulatory flow system. In the one-way system, it
uses fresh purified feed water for every sterilization run. In the feed water
circulatory flow system, the autoclave works in a more water-conserving
manner, since the feed water is used for several sterilization runs.
provided the instruments have been carefully prepared, that means
cleaned and rinsed (e.g. in a thermal disinfector).
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
MELAdest65. Or it gets the feed water fully automatically from the water
Installation material
Additional material, that can be ordered
36585
37410
1 Double hose nozzle with anti-flooding flap for connection to an available siphon drain
37400
37310
1 Additional water tap with return flow inhibitor and pipe aerator (to attach to an available angle
valve)
58130
01056
48240
1 Safeguard combination, consisting of return flow inhibitor and pipe aerator according to EN
1717
48660
Installation examples
Example 1 Standard scope of delivery
(1)
Safety valve
(2)
(3)
(4)
(5)
Power cable
(6)
Sterile filter
Figure 4: Direct feed water supply, wastewater drained off via one-way drain
(3)
(4)
(5)
(6)
(7)
Power cable
Example 2 MELAdem40
Supply of feed water from the Ion
exchanger MELAdem 40
Connection of the ion exchanger
10
(1)
Safeguard combination, consisting of a return flow inhibitor and pipe aerator according to EN 1717
optional
(2)
(3)
Leak monitor (water stop) with shut-off valve and probe (MELAG Art. No. 01056 optional),
recommended with fixed water connection
(4)
(5)
(6)
(7)
(8)
(9)
Double hose nozzle with anti-flooding flap (MELAG Art. No. 37400 optional)
(10)
(11)
Power cable
(12)
MELAdem40
(13)
Example 3 MELAdem47
Supply of feed water from the
reverse osmosis unit MELAdem47
Drain via the dual-chamber siphon
Connection of the reverse osmosis unit
Figure 6: Feed water supply from the reverse osmosis unit MELAdem47
(1)
Safeguard combination, consisting of a return flow inhibitor and pipe aerator according to EN 1717
optional
(2)
(3)
Leak monitor (water stop) with shut-off valve and probe (MELAG Art. No. 01056 optional),
recommended with fixed water connection
(4)
(5)
(6)
(7)
(8)
(9)
Double hose nozzle with anti-flooding flap (MELAG Art. No. 37400 optional)
(10)
MELAdem47
(11)
(12)
(13)
Power cable
(14)
11
and performed the initial start-up of the autoclave Euroklav 23 VS+/29 VS+ as described below:
Specialist dealer (name, address, stamp)
Remarks
Date
First installation
Subsequent
installation
The following persons were present during the instructions for use:
Name, first name (please print in block letters)
Signature
..
... .
..
..
12
Signature
Instructing technician:
..
..
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 MELAdem40 or MELAdem47 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 Euroklav23 VS+: front feet of the unit screwed out 5 rotations
O Euroklav29 VS+: front feet of the unit screwed out 3 rotations
Conduct and record a Vacuumtest with empty cold chamber and an Universal-Program with practice
relevant load (instruments)
O Universal-Program successfully executed with practice relevant load (instruments)
O Vacuumtest performed with empty cold chamber. Leakage rate: ..mbar/min.
O A printout of the programcycle was created with O No printer available leakage rate and successful
the log printer MELAprint 42 and pasted into lower
run of the Universal-Program were recorded in the
fields provided for this purpose
fields provided for this purpose
Check the time setting, if necessary reset the time according to instructions in the Technical Description
O Time is correct or correctly reset
Reset service meter according to separate instructions
O Service meter is reset
O
Instructing the operating personnel and handing over the technical documentation
O Operating personnel were instructed
O Technical Description was handed over
O Technical Manual was handed over
O Chamber certificate was handed over
O MPG 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
13
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.
14
Electromagnetic compatibility
Electromagnetic environment
Warning!
Emitted interference
measurements
Compliance
HF emissions
as per CISPR 11
Group 1
HF emissions
as per CISPR 11
Class B
Emissions of harmonics
as per IEC 61000-3-2
Class A
Interference
IEC 60601
immunity tests test level
Compliance level
Electrostatic
discharge (ESD)
as per
IEC 61000-4-2
Rapid transient
electrical
disturbances/
bursts as per
IEC 61000-4-4
Surges as per
IEC 61000-4-5
2kV common-mode
voltage
2kV common-mode
voltage
Voltage drops,
short-term
interruptions and
fluctuations of the
supply voltage as
per
IEC 61000-4-11
Magnetic fields
3 A/m
with the supply
frequency (50Hz)
as per
IEC 61000-4-8
3 A/m
15
Interference
IEC 60601
immunity tests test level
3 Veff
conducted HF
disturbances as
150 kHz to 80 MHz
per IEC 61000-4-6
radiated HF
3 V/m
disturbances as
per IEC 61000-4-3 80 MHz to 2.5 GHz
Compliance level
3 Veff
*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.
3
Within the frequency range of 150 kHz to 80 MHz, the field intensity should be less than 3 V/m.
d = 1 .2 P
d = 1 .2 P
d = 2 .3 P
16
0.01
0.12
0.12
0.23
0.1
0.38
0.38
0.73
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 tables
Nominal value tolerances
1. F.
2. F.
3. F.
4. F.
5. F.
Universal-Program
Press P Tolerance
250 + 50/- 20
2000 + 50/- 30
1200 + 30/- 50
2000 + 50/- 30
1200 + 30/- 50
2000 + 50/- 30
1200 + 30/- 50
2000 + 50/- 30
1200 + 30/- 50
2000 + 50/- 30
1200 + 30/- 50
2000 + 50/- 30
3050 + 70/- 30
3050 + 70/- 30
3170 + 90/- 90
1500 + 30/- 50
Quick-Pr. S
P
Tol.
500
Gentle-Pr.
P
Tol.
2060
2060
2170
Evacuate
Steam entry
Steam entry
Steam entry
Steam entry
Steam entry
Steam entry
Heat up
Sterilization start
Sterilization
Pressure release
Fractionation
Step
PreVacuum
Pressure-Time-Charts
17
18
10
mg/L
Silcon, SiO2
mg/L
Iron
0.2
mg/L
Cadmium
0.005
mg/L
Lead
0.05
mg/L
0.1
mg/L
Chlorides
mg/L
Phosphate
0.5
mg/L
ph value
57
Colour
Hardness
0.02
mmol/L
Minimum requirements to the quality of the feed water following the EN 13060, Appendix C
19
Brief instructions
Emergency door opening in case of power
failure
Warning!
Figure 11
On the left you can see how you can push the lever directly into the
groove of the grey plastic covering on the inside door of the autoclave
in order to reach the door lock.
Figure 12
When the lever is lying in the groove, pull the lever forward with your
right hand. With the other hand, push the sliding- closure grip
upwards.
Now you can open the door.
Figure 13
20
Figure 14
In the unlikely event that the device fuses (see page 5, Figure 1 /(8)) a are
triggered, replace them as follows:
Switch the autoclave off at the mains switch (see page 5, Figure 1/
(5)) and pull the power plug from the wall socket.
Due to the power failure which occurs when the device fuses are
triggered, you have to open the door with the help of the delivered
lever for emergency unlocking the door. Follow the instructions on
page 20, Emergency door opening in case of power failure.
Unscrew both screw caps of the fuse holder (page 5, Figure 1/(8)) at
the lower front of the autoclaves with a screwdriver or a coin.
There are two replacement fuses mounted on the inside of the
autoclave door (see figure on the left). Pull out the defect fuses and
insert the new fuses tightly into the fuse holder.
Screw the caps of the fuse holders back on at the lower front of the
autoclave.
Reconnect the power plug of the autoclave to the socket and switch
on the autoclave again at the mains switch.
If the fuses are triggered again, inform the MELAG customer service or
the customer service of your specialist dealer.
21
Initial state
Function
see next page
hh:mm:ss
0.00 bar 89C
h
P
AIN6: Conductivity
10 S/cm
Release
2nd time Press
Universal-Program
134C wrapped
h
Release
AIN4: Temp.preheat.
120C
Quick-Program B*
134C wrapped
S+
Supplement drying
selected
Program sequence
Quick-Program S
P
134C unwrapped
Manually terminate
before drying
START
Stop program?
button Stop
P
S
Program
stopped
Program runs
Gentle-Program
121C wrapped
Prion-Program
134C wrapped 20
pressure release
1.52 bar 112C
Stop/ End
0.02 bar 88C
Manually terminate
during drying
Stop program
button Stop
Immed. removal
press STOP
Bowie & Dick test
134C 2,2 bar 3.5
S
Drying stopped
Quick-Program S
run successfully
Vacuumtest
Acknowledge
with button -
Unlocking door
with button +
KEY
Program: "Enter/Confirm/Input
hh:mm:ss
0,00 bar 89C
Initial state
SETUP menu
Function:
Last
batch number
P
Last batch number
xx
Batch counter
Date/ Time
Date/ Time
Hour: xx
S
P
P
Immediate output
Yes/ No
= s. o.
2
S
No
Intern
One-way
Yes
Extern
circle
3)
Date/ Time
Second: xx
= s. o.
Date/ Time
Day: xx
= s. o.
Date/ Time
Month: xx
= s. o.
Date/ Time
Year: xx
Water system*
Feed water2)
supply*
autom.
Preheating
Output medium*1)
S
Date/ Time
Minute: xx
Batch output
Batch counter
xx
2
S
P
Stored cycles
output
2
S
P
Allocated: xx
Open: xx
= s. o.
All cycles
delete
2
S
P
Test output
2
S
KEY
Program: "Enter/Confirm/Input"
KEY
KEY
Main and submenus can be selected by KEY (+) next and KEY
(-) previous and you can always leave them with KEY (S).