MELAG Vacuklav 40 B+ Evolution User manual

Dear Dr.
We should like to extend our thanks for the expression of trust in our company which you have dis-
played through the purchase of this MELAG device.
As an owner-run and operated family concern founded in 1951, we have a long history of successful
specialization in hygiene products for practice-based use. Our focus on innovation, quality and the
highest standards of operational reliability has established MELAG as the world’s leading manufactu-
rer in the instrument treatment and hygiene field.
You, our customer are justified in your demand for the best products, quality and reliability. Providing
"competence in hygiene" and "Quality – made in Germany", we guarantee that these demands
will be met. Our certified quality management systems is subject to close monitoring: one instrument
to this end is our annual multi-day audit conducted in accordance with ISO 13485 and ISO 9001. This
guarantees that all MELAG products are manufactured and tested in accordance with strict quality
criteria.
The MELAG management and team.
User Manual
Steam sterilizer
Vacuklav®40 B+
Vacuklav®44 B+
as of software version 3.098

User Manual Vacuklav®40 B+ and Vacuklav®44 B+
Responsible for the contents: MELAG Medizintechnik oHG
MELAG Medizintechnik oHG
Geneststraße 6–10
10829 Berlin
Germany
E-mail: [e-mail]
www.melag.de
Document: BA_EN_40B+_44B+_v10.docx/ Revision: 10 – 16/1394
Alteration date: 28-06-2016
Subject to technical changes
For physicians, physician's assistants, and service personnel
Please read this User Manual b
efore you start operation of the steam sterilizer
. The
instructions contain important safety precautions. Make sure to keep the User Manual
near the steam sterilizer. The instructions are a part of the product.

Foreword
Thank you for deciding to buy this premium class MELAG steam sterilizer.
This User Manual describes both the steam sterilizers Vacuklav®40 B+
and Vacuklav
®44 B+. They are identical except for their chamber depth
and device depth.
Device name
The device name "steam sterilizer" is used in this User Manual to desig-
nate the steam sterilizers Vacuklav
®40 B+ and Vacuklav®44 B+.
User Manual
The User Manual contains important safety instructions and information
which you need to operate the
steam sterilizer. Read these instructions
carefully and thoroughly in proper sequence.
Avoid dangers
Please read all the safety instructions attentively before using the steam
sterilizer
.
About this manual
Symbol
Meaning
Explanation
Danger!
Risk to health
Indicates a dangerous situation which, if not avoided,
could entail slight to life-threatening injuries.
Warning!
Observe with-
out fail
Indicates a dangerous situation which, if not avoided,
could entail damage to the instruments, the practice
equipment or the steam sterilizer.
Notice
Important
information Indicates important information.
Table 1: Meaning of the symbols used in this User Manual
Example of emphasis
Meaning
Explanation
Universal-program
Software cita-
tion
Words or phrases appearing on the colour-touch dis-
play of the steam sterilizer are marked as software
citations.
Chapter 6 – Logging
Cross-reference
Reference to another text section within this User
Manual.
Fig. 1/(5)
Cross-reference
Reference to a detail in a figure – in the example, to
Part No. 5 in Figure 1.
Table 2: Meaning of the emphasized text within this User Manual

Symbols on the steam sterilizer
Symbols on the steam sterilizer
Symbol
Explanation
Manufacturer of the medical device
Date of manufacture of the medical device
Serial number of the medical device by the manufacturer
Article number of the medical device
Indication of the scale of the chamber volume
Operating temperature of the device
Operating pressure of the device
This User Manual contains important safety information. Failure to comply of the safety
instructions could result in human and material damage.
Please read this user manual carefully before commissioning the device. The manual
includes important safety information. The functionality and value-retention of this steriliz-
er depends on the care accorded to it. Please store this user manual carefully and in
close proximity to your sterilizer. It represents a component of the product.
The symbol of the crossed out waste bin identifies a device that must not be disposed in
domestic waste. The vendor is responsible for appropriate disposal of the device - it must
be delivered to the vendor to be disposed of. With the designation of an apparatus with
this symbol, the manufacturer furthermore declares that he satisfies all requirements of
the law concerning the release, redemption and environmentally sound disposal of elec-
tric and electronic appliances. MELAG devices are synonymous for long-term quality.
When you eventually need to decommission your MELAG device, we offer a special dis-
posal service. Simply contact your stockist.
In affixing the CE mark, the manufacturer declares that this medical product fulfils the
basic requirements of the medical products directive. The four-digit number confirms that
this is monitored by an approved certification agency.
In affixing this CE mark, the manufacturer declares that this medical product fulfils the
basic requirements of the pressure device directive. The four-digit number confirms that
this is monitored by an approved certification agency.
Indicates that operation of the steam sterilizer should follow according to the safety in-
structions in the User manual.
The manufacturer of the apparatus declares with the accompanying sticker that the medi-
cal device corresponds to the basic requirements of the European Standard EN1717 –
"Protection of drinking water from contaminants…."

Safety instructions
Safety instructions
To operate the steam sterilizer, pay attention to the following safety in-
structions given
below and in the individual chapters of this User Manual.
Instruction
■Do not sterilize any liquids with this steam sterilizer.
Power cable and power plug
■Never damage or change the main cable or power plug.
■
Never operate the steam sterilizer if the main cable or power plug are
damaged.
■
Never pull on the main cable to take it out of the socket. Always take
hold of the power plug itself.
Double jacket steam genera-
tor
■The steam sterilizer remains under pressure after being switched off.
Check the pressure display of the manometer located on the steam
sterilizer lower front side.
Setting up, installation,
commissioning
■Only have the steam sterilizer set up, installed, and commissioned by
people authorized by MELAG.
■
Only operate the steam sterilizer in areas which are not subject to
explosion hazards.
■
The electric connections and connections for feed water and used
water may only be completed by a specialist technician.
■
Documentation media (computer, CF card reader etc.) must be
placed in such a way that they cannot come into contact with liquids.
Preparation and sterilization
of textiles and instruments
■Follow the instructions of the textile and instrument manufacturers for
preparing and sterilizing textiles and instruments.
■
Observe the relevant standards and directives for the preparation and
sterilization of textiles and instruments, e.g. RKI [Robert Koch Insti-
tute] and DGSV [German Society for Sterile Supply].
■
Only use wrapping materials and systems which are suitable for
steam sterilization according to the manufacturer's information.
Program termination
■Take heed that when opening the door after terminating a running
program, hot water steam can escape out of the chamber, depending
on when the program was terminated.
■
Depending on the time of the program termination, the load might not
be sterile. Observe the clear instructions shown on the display of the
steam sterilizer. If necessary, sterilize the affected objects after re-
wrapping.
Removal of the items to be
sterilized
■Never open the door by force.
■
Use a tray lifter to remove the tray. Never touch the sterilized items,
the chamber or the interior of the door with unprotected hands. The
parts are hot.
■
Check the wrapping of the sterilized objects for damage when remov-
ing them from the steam sterilizer
. If a wrapping is damaged, wrap the
object again and re-sterilize it.
Maintenance
■Have the maintenance done only by authorized persons.
■
Comply with the predetermined maintenance intervals.
Carrying the steam sterilizer
■Two people are necessary to carry the steam sterilizer.
■
Use a suitable carrying strap to transport the steam sterilizer.
Errors
■If repeated error messages occur while operating the steam sterilizer,
turn the device off.
■
Only have the steam sterilizer repaired by authorized persons.

Contents
Contents
Symbols on the steam sterilizer.......................... II
Chapter 1 – Performance Specification.............. 3
Proper use.............................................................. 3
User benefit ............................................................ 3
Overview of sterilization programs.......................... 5
Chapter 2 – Device Description........................... 6
Scope of delivery.................................................... 6
Equipment views .................................................... 7
Effective capacity.................................................... 8
Mountings for the load ............................................ 8
The control panel.................................................... 9
LED status bar...................................................... 10
Supply with feed water ......................................... 11
Supply with cooling water ..................................... 11
Turning on the steam sterilizer ............................. 12
After turning on the device.................................... 12
Closing the door ................................................... 13
Chapter 3 – Initial commissioning .................... 14
Conditions for setting up, installing and
commissioning...................................................... 14
Set-up location requirements................................ 14
Connections required ........................................... 16
Prerequisites for initial commissioning.................. 16
Record of installation and setting up..................... 16
Chapter 4 – Sterilization..................................... 17
Create prerequisites ............................................. 17
Prepare items to be sterilized ............................... 17
Load the steam sterilizer ...................................... 18
Select program ..................................................... 21
Start program........................................................ 23
Program is running ............................................... 23
Sterilization phase is finished ............................... 25
Drying phase ........................................................ 25
Program is finished............................................... 25
Release process................................................... 26
Remove sterilized items ....................................... 26
Storage of sterilized items .................................... 27
Chapter 5 – Logging........................................... 28
Batch documentation............................................ 28
CF card as output medium ................................... 29
Using the PC as output medium ........................... 29
Using the log printer as output medium................ 30
Using the label printer as output medium ............. 30
Immediate automatic log output............................ 30
Subsequent output of stored logs......................... 31
Determine format for program log files ................. 33
Reading log files correctly .................................... 34
Finding logs .......................................................... 36
Chapter 6 – Settings........................................... 37
Setting date and time............................................ 37
User administration............................................... 37
Setting up the log printer as the standard printer.. 38
Setting up the label printer as a standard printer.. 39
Energy saving mode............................................. 39
Screensaver ......................................................... 40
Chapter 6 – Function test................................... 41
Automatic function test ......................................... 41
Manual function test ............................................. 41
Vacuum test.......................................................... 41
Bowie & Dick-Test ................................................ 42
Chapter 7 – Maintenance ................................... 43
Cleaning ............................................................... 43
Avoid formation of spots ....................................... 44
Use qualitatively high-grade feed water................ 44
Oil door spindle..................................................... 44
Maintenance......................................................... 45
Chapter 8 – Operating pauses........................... 46
Sterilization frequency .......................................... 46
Pause times.......................................................... 46
Decommissioning ................................................. 47
Transport .............................................................. 47
Re-commissioning after change of locality ........... 48
Chapter 10 – Errors ............................................ 49
A warning is not an error ...................................... 49
Messages ............................................................. 49
Warning messages............................................... 49
Error messages .................................................... 49
Before you call...................................................... 50
Bad drying results................................................. 53
Technical Specifications.................................... 54
Appendix A – Accessories................................. 55
Glossary .............................................................. 56

Chapter 1 – Performance Specification
3
Chapter 1 – Performance Specification
In this chapter you
learn

under which conditions and for which purpose you should use this steam sterilizer

what benefit you can achieve by using this steam sterilizer

which sterilization programs you can use
Proper use
Application area
The steam sterilizer is intended for use in the medical field, e.g. in general
physician and dental practices.
Sterilization tasks
According to DIN EN 13060 this steam sterilizer is considered a Class B
sterilizer. It is
designed as a universal steam sterilizer for demanding steri-
liz
ation tasks. For instance, you can sterilize narrow-bore instruments and
transmission instruments
– wrapped or unwrapped – and larger quantities
of textiles.
Danger
Observe the following instructions for using the steam sterilizer:
■Do not sterilize any liquids with this steam sterilizer
. It is not approved
for the sterilization of liquids.
Failure to observe these instructions may lead to delayed boiling,
damage to the steam sterilizer and burns.
Warning
!
■Use the steam sterilizer only for the intended purposes outlined in the
related technical documents and only in connection with the devices
and components recommended by MELAG.
■The sterilization of instruments and textiles with this steam sterilizer,
like the foregoing instrument sterilization, is only to be done by com-
petent personnel.
■Only use instruments, wrappings and textiles which are suitable for
steam sterilization according to the manufacturer's information.
Failure to observe these instructions may lead to damage and/or
safety of operation.
User benefit
Universal use
The steam sterilizer sterilizes on the basis of the fractionated vacuum
method. This ensures the complete and effective wetting or penetration of
the items to be sterilized with saturated steam. This method makes it po
s-
sible to sterilize all kinds of loads which occur in a ph
ysician's medical
practice.
Large quantities
Small time expenditure
No pause times
Overheating protection
To generate the sterilization steam, the steam sterilizer uses a double
jacket steam generator. Once heated up, it provides permanent steam.
The walls of the
sterilization chamber thus have a defined temperature.
The
sterilization chamber is protected from overheating and you can con-
secutively sterilize large qu
antities of instruments or textiles very rapidly
and achieve excellent drying results.

Chapter 1 – Performance Specification
4
Clean feed water
The steam sterilizer works with a one-way feed water system. This means
that it uses fresh purified feed water for every
sterilization run. The quality
of the feed water is constantly monitored via integrated conductivity mea
s-
urement. This prevents stains on instruments and soiling of the
steam
sterilizer
, assuming the instruments have been carefully prepared.
Automatic feed water supply
The supply with purified feed water for the steam production is automati-
cally supplied via an external water storage
container
or a water treatment
unit (e.g. MELAdem
®
40, MELAdem
®
47).
Optimal drying for wrapped
items to be sterilized
The items to be sterilized are dried by the vacuum (vacuum drying). This
way you achieve optimal drying results for wrapped objects as well.
Optimized total
operating time
The steam sterilizer works with an electronic parameter control. This way
the
steam sterilizer optimizes the total operating time of a program de-
pending on the load.
High degree of safety by
extensive safety devices
The steam sterilizer checks the pressure and temperature in the steriliza-
tion
chamber at all times and does not permit the door to be opened in
case of overpressure in the chamber. The motor
-operated automatic door
lock slowly opens the door by turning the locking spindle and holds the
door while it opens. Pressure compensation takes place even if there is
any difference in pressure until the door
is completely opened.
The quantity and quality of the feed water is checked.
A process evaluation system is integrated in the electronics of the
steam
sterilizer
. During a program it compares such process parameters as tem-
peratures, times and pressures with each other. It monitors the parameters
with respect to their limit values at activation and control and guarantees a
safe and successful
sterilization.
A monitoring system checks the device components of the
steam sterilizer
with respect to their functi
onal reliability and their plausible interaction.
If one or more parameters exceed defined limits, the
steam sterilizer is-
sues warnings or error messages, and if necessary aborts the program. In
the event of an automatic program abort, observe the informat
ion on the
display.
Additional function check
You can conduct an additional function check at any time with the help of
test programs.
Use the vacuum test to check the
steam sterilizer for leaks in the steam
system.
Use the Bowie & Dick test to check
whether there is sufficient steam pene-
tration for porous material to be sterilized (e.g. textiles).
Effective batch
documentation
The steam sterilizer has an internal log memory. All data of the completed
sterilization
programs are automatically stored here.
You can read out the internal log memory immediately after the end of the
program, or at a later time. You determine whether the logged data are
issued to one or several different output media (e.g. log printer
MELAprint
®42, MELAflash CF card, computer).

Chapter 1 – Performance Specification
5
Overview of sterilization programs
Type tests
Universal-
Program
Quick-
Program B
Quick-
Program S
Gentle-
Program
Prion-
Program
Program type as per DIN EN 13060
Type B
Type B
Type S
Type B
Type B
Dynamic pressure test of the sterili-
zation chamber
X
X
X
X
X
Air leak
X
X
X
X
X
Empty chamber test
X
X
X
X
X
Solid load
X
X
X
X
X
Porous partial load
X
-
-
X
X
Porous full load
X
-
-
X
X
Simple hollow items (Hollow body B)
X
X
X
X
X
Narrow lumen (Hollow body A)
X
X
X
X
Simple wrapping
X
X
X
X
Multiple wrapping
X
X
X
Drying solid load
X
X
X
X
X
Drying porous load
X
-
-
X
X
X = Conformity with all applicable sections of the standard DIN EN 13060
Table 4: Overview of sterilization programs

Chapter 2 – Device Description
6
Chapter 2 – Device Description
In this chapter you learn

which components are included in the standard scope of delivery

which components the steam sterilizer contains

what safety devices the steam sterilizer has

how the operating elements are designed and how you should use them

how the menus of the user interface are structured

which acoustical signals the steam sterilizer emits

what kind of water supply the steam sterilizer needs
Scope of delivery
Standard scope of delivery
Vacuklav®40-B+ or Vacuklav®44-B+

User Manual

Certificate of conformity with the Medical Device Directive

Certificate of conformity with Pressure Equipment Devices Directive

Warranty certificate

Technical manual

Installation and assembly report

Mounting for the load

Tray lifter

Waste water hose, PVC fabric, 2 meters

Pressure hose water feed, 2.5 meters

Allen key wrench for emergency opening of the door

Torx wrench to remove the carrying strap

Guide sleeve

Feed water connection

Dual-chamber wastewater trap

Feed water container with intake hose (if delivered without
MELAdem®)
Optionally
Trays

Standard tray cassettes and lifter

MELAstore-Trays

MELAstore-Boxes

Additional tray mounts

MELAflash CF card

MELAflash CF card reader

Waste water hose, PVC fabric, 5 meters

Pressure hose water feed, 4.5 meters

Chapter 2 – Device Description
7
Equipment views
Front view
(1)
(2)
(3)
(4
)
(5
)
(6
)
(7
)
(8
)
(9
)
(10
)
(11
)
(12
)
Slot for the
CF card
C
olour-touch display
LED
status bar
Door (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
Cap for emergency switch
-on of the vacuum pump
Mains
switch (concealed, accessible from the side)
Ethernet
-1 data connection*
Reset button protective motor switch*
Reset button overheating protection*
Front foot of the unit (adjustable)
*behind covering
Rear view
(13
)
(14
)
(15
)
(16
)
(17
)
(18
)
(19
)
(20
)
(21
)
(22
)
(
23)
(24
)
Fan
Ethernet
-2 data connection
Ethernet
-3 data connection* (can be retrofitted)
Power cable
O
ptional connection for a Flex Display
Cavitation protection valve
Safety
spring valve chamber
Sterile filter
Safety
spring valve, double jacket
Cooling water
inlet (3/4" outside thread)
Feed water intake (for external water storage
container
or MELAdem
®; swivelling threaded fitting for hose 6x1,
alternatively straight)
Cooling water outlet (3/4" outside thread)
Fig. 1: Front and rear view

Chapter 2 – Device Description
8
Interior view
(
1)
(
2)
(
3)
(
4)
(
5)
(
6)
(
7)
Chamber
Mounting to hold the load
Door spindle
Threaded bushing
Chamber sealing surface
Door seal
Door plate
Fig. 2: Interior view
Effective capacity
The steam sterilizers Vacuklav®40 B+ and Vacuklav®44 B+ differ only with
respect to the respective depth of the units. As a result, their effective
capacities are different.
Diameter
Depth
Vacuklav®40 B+
25 cm
35 cm
Vacuklav®44 B+
25 cm
45 cm
Table 1: Dimensions of the effective capacity
Mountings for the load
The
steam sterilizer is always delivered with a mounting to hold trays or
cassettes.
The mounting (C) is standard and can hold either six trays
or three
MELAstore-Boxes 100 rotated by 90˚.
Fig. 3: Mounting C
The mounting (B) can hold four standard tray cassettes or four trays.
Fig. 4: Mounting B
The mounting (D) can hold two high cassettes (e.g. for implants), two
MELAstore
-Boxes 200 or - rotated by 90°- four trays.
Fig. 5: Mounting D

Chapter 2 – Device Description
9
The control panel
The control panel consists of a coloured 5 inch Touch Display.
Symbols in the status bar
Meaning
Programs/Tests
Indicates a program is running
Immediate output
Indicates whether immediate output is activated/deactivated
Supplemental drying
Indicates whether supplemental drying is activated/deactivated
Graphic logs
Indicates whether recording of graphic logs is activated/deactivated
Energy saving mode
Indicates whether steam sterilizer is in energy saving mode
Service area
Indicates whether a service technician is logged in to the service area
CF card Status
Indicates whether a CF card is inserted and whether read or write access
is in place
Status bar
Menu bar
Action bar
Main display

Chapter 2 – Device Description
10
Symbols in the menu bar
Meaning
Programs/Tests
all sterilization programs and tests are found here, e.g. vacuum test,
Bowie & Dick Test, etc.
Log output
the entire log list, logs from a defined time period, e.g. daily, monthly, etc
or specific log types can be found here such as the option to delete logs
Settings
various settings can be made, e.g. date and time, brightness etc. In
addition, Standard log settings for log output can be set here
Info-/
Status window
indicates information regarding software version and device dates, e.g.
batch lot, maintenance meter, log settings, log memory and other tech-
nical values
Service area
only for technicians
Help menu
depending on the selected window and control status, gives information
for control or function of the actual window
Symbols in the action bar
Meaning
Door open
opens the steam sterilizer door
Back
changes to the previous window
Forward
changes to the next window
Terminate/
go back without
saving
returns to the superior menu, closes the window without saving
Zoom (+)
indicates additional details, e.g. additional values after the end of a pro-
gram run
Pre-selection
start time
changes to the “Pre-selection start time” menu
Delete
deletes logs from the internal log memory / deletes the log printer or
label printer stored as standard
Find
finds the label printer(s)/log printer(s)
LED
status bar
The status bar located on the border of the display indicates colours for
various situations, e.g. in Standby during the running of a
program or for
warning or malfunction messages
.
blue
- Standby, program is running, drying has not yet begun
gr
een– drying is running, program completed successfully.
yellow
– for warning messages, during software update.
red – for malfunction messages, program not completed successfully.

Chapter 2 – Device Description
11
Supply with feed water
The steam sterilizer requires demineralized or distilled feed water for gen-
erating steam. The feed water supply is provided either with an external
water storage
container or with a water treatment unit (e.g.
MELA
dem®40 / MELAdem®47). The steam sterilizer
automatically sucks in
the feed water.
Feed water from external
water storage container
If you deploy an external water storage container for the feed water sup-
ply, you must fill it manually from time to time. Employ only water available
on the market according to
DIN EN 13060, Appendix C as feed water.
Water storage container
from MELAG
The water storage container from MELAG has a capacity of maximum
11.5 litters. This quantity of feed water is enough for up to 25
sterilizations.
Distilling unit MELAdest®65
With the MELAdest®65 distilling unit, you can produce feed water cost
effectively for all practices.
Feed water with water
treatment unit
A water treatment unit is connected to the drinking water grid. It produces
the feed water required for generating the steam for the
steam sterilizer.
The purified feed water connection for the
steam sterilizer is directly con-
nected to the water treatment
unit.
If you use a water treatment unit, then there is always sufficient feed water
available. You no longer need to fill the water storage
container.
Water treatment units
MELAdem®
40 and
MELAdem®47
The water treatment units MELAdem®40 and MELAdem®47 produce the
optimal purified feed water quality for the
steam sterilizer. The selection of
the respective unit depends on the number of
sterilizations per day and
the respective loads. Every MELAG
steam sterilizer can be supplemented
with a water treatment unit.
NOTICE!
Please first consult with MELAG if you would like to use water treatment
units from other manufacturers.
Supply with cooling water
The pump for the vacuum creation is cooled with water.
The cooling water inlet is connected with a customer
-side faucet for this
purpose. The used cooling water is disposed of in a customer
-side drain.

Chapter 2 – Device Description
12
Turning on the
steam sterilizer
Danger
Observe the following safety measures when handling the main
power cable and the power plug:
■Do not splice or alter the power cable.
■Do not bend or twist the power cable.
■Do not tug on the power cord to remove the plug from the outlet.
Always grasp the plug directly.
■Do not place heavy objects on the power cable.
■Do not lay the power cable over objects in which it may get caught
(e.g. doors or windows).
■Do not lay the power cord across a heat source.
■Do not use nails, staples or other such objects to affix the cable
■If the power cable or plug becomes damaged, do not use the steam
sterilizer. The power cable or plug should only be replaced author-
ised persons.
Failure to observe these measures may lead to damage to the cable
or plug and/or to fire or electrical shock. Severe injuries may result.
Place the power plug into the
power outlet
If the steam sterilizer is not connected to the power supply, place the pow-
er plug into the power outlet.
Turn on the steam sterilizer
Turn on the steam sterilizer using the power switch.
After turning on the
device
The display will indicate Welcome. The software of the steam sterilizer will
initialis
e and the device components will be tested.
The water level of
the feed water in jacketed steam generator will be test-
ed automatically and
fixed if necessary during the feed process (feed
pump will run).
The feed water will be heated for the steam generation.
Set-up time
After the steam sterilizer is turned on using the power switch, a one-time
warm
-up period is required to heat the jacketed steam generator. For nor-
mal use, this takes:

Vacuklav®40 B+: 9 minutes

Vacuklav®44 B+: 13 minutes
The display indicates the program menu each time the machine is turned
on.
The default setting is the Universal-Program.

Chapter 2 – Device Description
13
Closing the door
Warning
When closing the door of the steam sterilizer, observe the following
instructions :
■Do not press the door too hesitantly against the steam sterilizer hou
s-
ing.
■Hold the door pressed closed for at least 3 seconds.
■Under no circumstances should you slam the door shut.
Failure to observe these instructions may impair the functional reli-
ability of the door lock mechanism.
The steam sterilizer has an automatic motor-driven door lock with thread-
ed spindle.
In order to lock the door, press it tightly closed.
The door locks pressure
-proof once the program is started.
Locked door
Inputs at the display of the steam sterilizer are only possible when the
steam sterilizer door is locked.
NOTICE!
Leave the door open only for loading and unloading the
steam sterilizer. If
you keep the door closed, you will save energy.

Chapter 3 – Initial commissioning
14
Chapter 3 – Initial commissioning
In this chapter you learn

who may set up, install and commission the steam sterilizer

which prerequisites you must create for setting up, installing and commissioning
the steam sterilizer

where you will find additional information
Conditions for set
ting up, installing and
commissioning
Danger
■Only have the steam sterilizer set up, installed, and commissioned by
people authorized by MELAG.
■According to the currently valid VDE standards, this device is not
suitable for use in areas subject to explosion hazards.
Failure to observe this precaution may lead to damages to the
steam
sterilizer and/or injuries.
Warning
■The steam sterilizer is intended for use outside the patient environ-
ment. The minimum distance to the treatment area must have a radi-
us of at least 1.5 meters.
Failure to observe this precaution may lead to damages to the
steam
sterilizer and/or injuries.
Set
-up location requirements
Location
Set up the steam sterilizer in a dry and dustproof location. The air humidity
should be 30% to 60% and the ambient temperature 16° to 26˚C.
Warning
■Without fail, keep the specified distance free to the surrounding sur-
faces at the sides and above the steam sterilizer.
Failure to observe these guidelines may lead to heat accumulation.
This could adversely affect the function of the steam sterilizer.
Distance to the surrounding
surfaces
The distance above and to the side of the steam sterilizer to the surround-
ing surfaces must be at least five centimetres.

Chapter 3 – Initial commissioning
15
Space requirements
Vacuklav®40 B+
Vacuklav®44 B+
Width
A
47 cm
47 cm
Hight
B*
56.5* cm
56.5* cm
Depth
C
59 cm
69 cm
C1
25 cm
36 cm
C2
23.5 cm
18 cm
D1
5 cm
5 cm
D2
14 cm
14 cm
E
5 cm
5 cm
G
5 cm
5 cm
* with Flex Display B=50 cm (dimensions to upper edge of the steam sterilizer without display)
Additional space for feed
water supply
Other than the space for the steam sterilizer, you will require space for the
external water storage
container or for a water treatment unit for the feed
water supply.
Space requirements for
external water storage
container
The external water storage container can stand next to the steam steriliz-
er
. A position above or below the steam sterilizer is also possible.
The
space requirements for the MELAG water storage container is 19
centimetres in width, 32 centimetres in height and 23 centimetres in depth,
as well as additional space
above for the tube connections.
NOTICE!
In no case may you subject the water storage
container to sunlight. This
way you avoid algae formation.
The maximum suction height for an external water storage
container
is 1.5
meters.
Space requirements for a
water treatment unit
MELAdem®40

Can be directly attached to the steam sterilizer

The attachment can be next to the steam sterilizer or above or below
the steam sterilizer
MELA
dem®47

Attachment next to the steam sterilizer or above or below the steam
sterilizer (e.g. lower cabinet)

is delivered with water storage container
Width
Height
Depth
Diameter
MELAdem®40
32 cm
35 cm
15 cm
MELAdem®47 module housing
39 cm
47 cm
15 cm
MELAdem®47 water storage tank
51 cm
24 cm
Table 2: MELAdem®Space requirements

Chapter 3 – Initial commissioning
16
Connections required
Danger
■The electric connections and connections for feed water and used
water may only be completed by a specialist technician.
Failure to observe this caution may lead to a short-circuit and/or fire
and/or water damage and/or electrical shock. Serious injuries may
result.
Electrical connection
Provide the following electrical connections for the steam sterilizer:

Electric circuit with 220-240 V (max. voltage range 207-253 V) and
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 sepa-
rate fuse protection)

Protection from leakage current 30 mA
Cooling water inlet
A pressure hose is provided for the connection of the cooling water inlet at
a customer
-side faucet.
NOTICE!
In order to prevent water damage, MELAG recomm
ends the use of a leak
monitor
.
Cooling-water discharge
The waste water hose can be connected as follows:

On an existing rinsing drain when using the dual-chamber siphon
instead of the existing siphon.

on a separate discharge pipe when using the surface-
mounted siphon
from MELAG (Art.-no. 37410 which is not in the standard scope of de-
livery). The drain must be located below the steam sterilizer.
NOTICE!
The waste water hose must be able to be laid with a continuous dip
-free
descent.
For wastewater paths which are longer than two meters, MELAG reco
m-
mends a fixed lay
out of HT (high temperature) pipe carried out by a spe-
cialized installation firm.
Prerequisites for initial commissioning
The following prerequisites must be satisfied for initial commissioning:

The cooling water inlet for the vacuum pump must be open.

The feed water supply must be secured. For the first-filling of the
steam generating system the steam sterilizer requires about three li-
tres feed water.

The power supply of the steam sterilizer must be assured.

If available, the MELAflash CF card should be plugged in the card
slot.
Record of installation and setting up
NOTICE!
As documentation of proper setting up, installation and commissioning as
well as for your warranty claim, the record of installation must be filled out
by the person responsible and a copy send to MELAG.