We should like to extend our thanks for the expression of trust in our company which you have displayed through
the purchase of this MELAG product.
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 manufacturer 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.
Please read this
. The
instructions contain important safety precautions. Make sure to keep the
Manual
near to the steam sterilizer. The instructions are a part of the product.
For physicians, physician's assistants, and service personnel
User Manual before you start operation of the steam sterilizer
Thank you for deciding to buy this Pro Class MELAG steam sterilizer.
This User Manual describes both the steam sterilizers Vacuklav 24 B+ and
Vacuklav
device depth.
Device name
The device name "steam sterilizer" is used in this User Manual to
designate the steam sterilizers Vacuklav
User Manual
The User Manual contains important safety instructions and information
which you need to operate the
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
Risk to health
Indicates a dangerous situation which if not avoided
Observe
Indicates a dangerous situation which if not avoided
Important
Indicates important information.
Example of emphasis
Meaning
Explanation
Universal program
Software
Words or phrases appearing on the →display of the
Chapter 6 – Logging
Cross-
Reference to another text section within this User
Figure 1/(5)
Cross-
Reference to a detail in a figure – in the example, to
30 B+. They are identical except for their chamber depth and
24 B+ and Vacuklav 30 B+.
steam sterilizer. Read these instructions
.
Danger!
Warning!
without fail
information
citation
reference
reference
could entail slight to life-threatening injuries.
could entail damage to the instruments, the practice
equipment or the steam sterilizer.
steam sterilizer are marked as software citations.
Manual.
Part No. 5 in Figure 1.
Symbols on the device
The manufacturer of the apparatus declares with the accompanying sticker that the
medical device corresponds to the basic requirements of the European Standard EN1717
–
With the CE sign the manufacture
basic requirements of the Ge
means that an approved certification body monitors the product certification.
With the CE sign CE 0035, the manufacturer declares that the medical device
corresponds to the basic requirements of the German Printing Device Guideline. The
four
certification.
Manufacturer of the medical device
Date of manufacture of the medical device
Serial number of the medical device by the manufacturer
Article number the medical device
This User Manual contains important safety informations.
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
sterilizer depends on the care accorded to it. Please store this user manual carefully a
in close proximity to your sterilizer.
The symbol of the struck out trashcan identifies a device that may not be disposed with
domestic waste. An appropriate and competent disposal must be carried out by th
marketing party. With the designation of an apparatus with this symbol, the manufacturer
furthermore declares that he satisfies all requirements of the law concerning the release,
withdrawal and environmentally compatible disposal of electric and electro
MELAG devices are synonymous for long
decommission your MELAG device, we offer a special disposal service.
your stockist.
Indication of the scale of the chamber volume
Op
Operating pressure
Symbols on the device
"Protection of drinking water from contaminants…."
-digit number means that an approved certification body monitors the product
r declares that the medical device corresponds to the
rman Medical Device Guideline. The four-digit number
-retention of this
nd
It represents a component of the product.
e
nic appliances.
-term quality. When you eventually need to
Simply contact
erating temperature of the device
of the device
Safety instructions
Safety instructions
To operate the steam sterilizer, pay attention to the following safety
Instruction
■ Do not sterilize any liquids with this steam sterilizer.
Mains cable and power
■Never damage or change the mains cable or power plug.
ke it out of the socket. Always take
Setting up, installation,
■ Only have the steam sterilizer set up, installed, and commissioned by
Preparation and
sterilization of textiles and
■Follow the instructions of the textile and instrument manufacturers for
up conditions can result in malfunctions
Program termination
■Take heed that when opening the door after terminating a running
program, hot water steam can escape out of the chamber, depending
Depending on the time of the program termination, the load might not
Removal of the items to be
■ Never open the door by force.
Maintenance and service
■ Have the maintenance done only by authorized persons.
Carrying the steam
■ Two people are necessary to carry the steam sterilizer.
Errors
■If repeated error messages occur while operating the steam sterilizer,
instructions given below and in the individual chapters of this User
Manual.
plug
commissioning
instruments
■Never operate the steam sterilizer if the mains cable or power plug
are damaged.
■Never pull on the mains cable to ta
hold of the power plug itself.
people authorised 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.
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
Institute] 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.
■ Only ever operate the steam sterilizer with a sterile filter inserted.
■ Failure to comply with the set-
or damage to the autoclave and/or human injury.
on when the program was terminated.
■
be sterile. Observe the clear instructions shown on the display of the
steam sterilizer. If necessary, sterilize the affected objects after
rewrapping.
sterilized
sterilizer
■Use a tray lifter to remove the tray. Never touch the sterilized items,
the chamber or the door with unprotected hands. The parts are hot.
■Check the wrapping of the sterilized objects for damage when
removing them from the steam sterilizer. If a wrapping is damaged,
wrap the object again and re-sterilize it.
■ The sterilizer may only be serviced by authorized personnel.
■ The sterile filter must be sterilized or replaced following a power
outage suffered in over-pressure or following the incidence of the
malfunction message Malfunction 32.
■Use a suitable carrying strap to transport the steam sterilizer.
turn the device off and notify your specialist dealer.
■Only have the steam sterilizer repaired by authorized persons.
Technical Data .................................................... 60
Appendix A – Accessories................................. 61
Chapter 1 – Performance Specification
Chapter 1 – Performance Specification
In this chapter you learn
Application area
The steam sterilizer is intended for use in the medical field, e.g. in
Sterilization tasks
According to DIN EN 13060 this steam sterilizer is considered a Class B
Observe the following instructions for using the steam sterilizer:
■ Use the steam sterilizer only for the intended purposes outlined in
Universal use
The steam sterilizer sterilizes on the basis of the fractionated pre-vacuum
method. This ensures the complete and effective wetting or penetration
of the items to be sterilized with saturated steam. This method makes it
possible to sterilize all kinds of loads which occur in
practice.
Large quantities
To generate the sterilization steam, the steam sterilizer uses a separate
steam generator. At program start, steam is generated and conducted
into the sterilization chamber. A defined pressure and a prescribed
temperature is thereby given. The sterilization chamber is protected from
overheating and you can conse
instruments or textiles very rapidly and achieve excellent drying results.
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
clinics, and in physician and dental practices.
Danger of burning!
Warning!
sterilizer. It is suited as a universal steam sterilizer for demanding
sterilization tasks. For instance, you can sterilize narrow-bore
instruments and transmission instruments – wrapped or unwrapped –
and larger quantities of textiles.
■Do not sterilize any liquids with this steam sterilizer. It is not
approved for the sterilization of liquids.
In case of non-observance, the consequences could be delayed
boiling, damage to the steam sterilizer and burns.
the related technical documents and only in connection with the
devices and components approved by MELAG.
■The sterilization of instruments and textiles with this steam sterilizer,
like the foregoing instrument preparation, is only to be done by
competent personnel.
■Only use instruments, wrappings and textiles which are suitable for
steam sterilization according to the manufacturer's information.
In case of non-observance the consequences can entail damage to
the steam sterilizer and/or to the items to be sterilized.
User benefit
a physician's medical
Low time expenditure
Overheating protection
No pause times
cutively sterilize large quantities of
7
Chapter 1 – Performance Specification
Automatic pre-heating
The cold chamber is preheated on activation of preheating or can be
maintained at a specific temperature between two s
This shortens the program time periods and reduces the formation of
condensate to give improved drying results.
Clean feed water according
to DIN EN 13060
The steam sterilizer functions according to the feed water one-way
system. This me
sterilization run. The quality of the feed water is monitored via integrated
conductivity measurement. This prevents stains on instruments and
soiling of the
carefully prepared.
Automatic feed water
The feed water supply for the steam production is provided automatically
with an external water storage
treatment unit
Optimal drying for
The drying of the sterilizing materials is carried out with the post-vacuum
method (vacuum drying).
wrapped objects as well
Optimized total operating
The steam sterilizer works with an electronic parameter control. This way
the
depending on the load.
High safety with
The steam sterilizer verifies pressure and temperature in the sterilization
chamber at all times and its door locking system does not permit opening
the door when there is overpressure in the chamber.
A process evaluation system is integrated in the electronics of the
sterilizer
and pressure during a program. It monitors the parameters with respect
to their limit values at activation and control and guarantees a safe and
successful sterilization.
If one or more parameters are above or fall
values, the
necessary
abort, observe the information on the display.
Additional
With the help of the test programs, you can conduct an additional
function check at any time.
Use the vacuum test to check the
system.
With the Bowie & Dick
sufficient steam penetrati
With
feed water.
Effective batch
The steam sterilizer has an internal log memory which can save up to 40
program cycles. All data of the completed 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.
terilizations.
ans that it uses fresh purified feed water for every
steam sterilizer, assuming the instruments have been
supply
wrapped items to be
sterilized
time
extensive
safety devices
function check
container (Art. No. 00244) or a water
(e.g. MELAdem 40, MELAdem 47).
This way you achieve optimal drying results for
.
steam sterilizer optimizes the total operating time of a program
steam
. It monitors the process parameters such as temperature, time
below the determined limit
steam sterilizer outputs a warning or fault messages and, if
, aborts the program. In the event of an automatic program
steam sterilizer for leaks in the steam
-test, you can verify the steam sterilizer for
on of porous sterilizing materials (e.g. textiles).
Conductivity measurement, you can verify the water quality of the
documentation
8
Type tests
Universal-
Quick-
Quick-
Gentle-
Prion-
Program type as per
Type B
Type B
Type S
Type B
Type B
Dynamic pressure test of the
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 instruments
X
Instruments with 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
Overview of sterilization programs
Chapter 1 – Performance Specification
DIN EN 13060
sterilization chamber
(hollow body B)
Program
Program B
Program S
Program
Program
9
Chapter 2 – Device Description
Chapter 2 – Device Description
In this chapter you learn
Scope of delivery
Standard scope of delivery
Vacuklav 24 B+ or Vacuklav 30 B+
As option
Trays
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 What kind of water supply the steam sterilizer needs
User Manual
Technical Manual
Warranty certificate
Manufacturer's inspection report
Pressure device directive certificate
Record of installation and setting up
1 mounting for trays or cassettes
1 waste water hose, PVC fabric, 2 metres
1 pressure hose water feed, 2.5 metres
1 TORX key for removing the carrying strap
1 tank filter key
Guide sleeve
Feed water connection
Dual-chamber siphon
Feed water container with intake hose (if delivered without
MELAdem
Lever for emergency unlocking of the door
10
2 replacement device fuses on the inside door of the steam
sterilizers
Tray lifter
Standard tray cassettes and lifter
Additional tray mounts
Log printer MELAprint 42
MELAflash CF card Printer with CF card and card reader
MELAnet Box
Waste water hose, PVC fabric, 5 metres
Pressure hose water feed, 4.5 metres
)
Chapter 2 – Device Description
Device views
Front side
(1)
(2)
(3)
(4)
(5)
Operating and display field
Door (pivots opens to the left)
sliding closure
Mains switch
Front foot
Front side below with opened door
(6)
Serial data and printer connection (RS232)*
(7)
Cap for emergency switch-on of the vacuum pump
(8)
(9)
2x Device fuses
Reset button for protective motor switch
*hidden behind the white cover
Back side
(10
(11
(12
(13
(14
(14
(15
Safeguard combination according to EN 1717
Safety valve
Sterile filter
Cooling water inlet (3/4" outside thread)
Cooling water outlet
Power cable
Feed water intake for external water storage
MELA
grip
of the unit (adjustable)
Fig. 1: Device views
)
)
)
)
)
)
)
(3/4" outside thread)
dem, swivelling threaded fitting for hose ∅ 6x1
container or
11
Chapter 2 – Device Description
Interior view
(1)
(2)
(3)
(4)
(5)
(6)
Chamber
Mounting to hold trays/ cassettes
Door locking pin
Chamber sealing surface
Blue door seal
Round blank
Effective capacity
Device type
Diameter
Depth
Volume
Vacuklav 24 B+
∅ 25 cm
45 cm
22 litres
Vacuklav 30 B+
∅ 25 cm
35 cm
17 litres
Mountings for the load
The steam sterilizer is always delivered with a mounting to hold
trays or cassettes.
The mounting (A) is standard and can hold either five trays or three
standard tray
The mounting (B) can hold four standard tray cassettes or four
trays.
The mounting (D) can hold two high cassettes (e.g. for implant
cassettes) or four trays rotated by 90°.
Fig. 2: Interior view
Fig. 3: Mounting A
Fig. 4: Mounting B
Fig. 5: Mounting D
12
cassettes rotated by 90°.
Chapter 2 – Device Description
Control panel
The control panel consists of a two-line alphanumerical LED display and four
Initial state
The display switches to the initial state after every switch-on, where the
current time and the chamber p
temperature in °C is displayed.
Supply with feed water
The steam sterilizer requires demineralized or distilled feed water for
steam production according to
provided
treatment unit (e.g. MELA
automatically sucks in the feed water.
Feed water from external
If you employ an external water storage container for the feed water
supply, you must fill
time, the
water according to
Water storage container
The water storage container from MELAG has a capacity of maximum
11.5 litres.
Feed water with water
A water treatment unit is connected to the domestic water supply. It
produces the feed water required for generatin
sterilizer
connected to the water treatment unit.
If you employ a water treatment unit then there is always suffici
water
tank.
Function key (-) and (+)
to select, set and display
print
conductivity, acknowledge erro
for unlocking the door
Program selection button (P)
to select the sterilization programs/ test
programs and select or set options
of the special functions
Start – Stop button (S)
to start programs, terminate
programs /
control of the special
Time (h:min:s)
chamber pressure (bar) and
(steam)
KEY
2-line LED display
for program status display and
parameter display
membrane keys.
- temperature (°C),
(+) for unlocking the door
, date/time, preheating, total batches,
special functions:
r
r, KEY(+)
(submenus)
drying as well as
functions
ressure in bar and the (steam)
DIN EN 13060. The feed water supply is
either by an external water storage container or with a water
dem 40/ MELAdem 47). The steam sterilizer
water storage container
steam sterilizer outputs an appropriate message. Only use
from MELAG
This quantity of feed water suffices for up to 25 sterilizations.
treatment unit
. The feed water intake of the steam sterilizer is directly
available. You no longer have to manually fill the water storage
it manually from time to time. At the given point in
DIN EN 13060 as feed water.
g the steam for the steam
ent feed
13
Chapter 2 – Device Description
Water treatment units
The water treatment units MELAdem 40 and MELAdem 47 produce
optimal feed water quality for the
respective unit depends on the number of sterilizations per day and the
respective
with a water treatment unit.
NOTICE!
Please first consult with MELAG if you would like
treatment units of other manufacturers.
Supply with cooling water
The pump for the vacuum creation is cooled with water.
The cooling water inlet of the
side faucet for this purpose. The used cooling water is disposed of via a
customer
MELAdem 40 and
MELAdem 47
loads. Both MELAG steam sterilizers can be supplemented
steam sterilizer. The selection of the
to employ water
steam sterilizer is connected to a customer-
-side drain.
14
Chapter 3 – Initial start-up
Chapter 3 – Initial start-up
In this chapter you learn
Conditions for setting up, installing and
starting up
■ Only have the steam sterilizer set up, installed, and started up by
■ According to the currently valid VDE standards, this device is not
Set
Location
Set up the steam sterilizer in a dry and dustproof location. The relative
humidity should amount to
fashion up to a relative humidity of
an ambient
■Without fail, keep the specified distance free to the surrounding
shortening of the vacuum pump's service life and result in extended
Distance to the surrounding
The distance above and to the side of the steam sterilizer to the
surrounding surfaces must be at least five centimetres.
Who may set up, install and start up the steam sterilizer Which prerequisites you must create for setting up, installing and starting up the
steam sterilizer
people authorized by MELAG.
Danger!
Warning!
surfaces
suitable for use in areas subject to explosion hazards.
■The steam sterilizer is intended for use outside the patient
environment. The minimum distance to the treatment area must
have a radius of at least 1.5 metres.
Damages to the steam sterilizer and/or injuries can occur in case
this precaution is not observed.
-up location requirements
max. 80% at 31 °C, decreasing in a linear
max. 50% at 40 °C. We recommend
temperature of between 5-40 °C (recommended max. 25 °C).
surfaces at the sides and above the steam sterilizer.
Non-observance can lead to heat accumulation. This could
adversely affect the function of the steam sterilizer and entail the
program times.
15
Chapter 3 – Initial start-up
Space requirements
Vacuklav 24 B+
Vacuklav 30 B+
Width
A= 42.5 cm
A= 42.5 cm
Additional space for
Other than for the steam sterilizer, the external storage container or a
water treatment unit for the feed water supply require space.
Space requirements for
external water storage
The external water storage container can stand next to the steam
sterilizer
The s
centimetres in width, 32 centimetres in heigh
NOTICE:
In no case may you subject the water storage tank to sunlight. This way
you avoid algae formation.
The maximum suction height from the external storage
metres.
Space requirement for
water treatment unit
MELAdem 40
MELA
Water treatment unit
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
Connections required
■ The electric connections and connections for feed water and used
and/or fire and/or water
Height
Depth
feed water supply
. A position above or below the steam sterilizer is also possible.
container
pace requirements for the MELAG water storage container is 19
B= 49 cm
C= 72 cm
D= 43 cm
E= 10 cm
F= 5 cm
t and 23 centimetres in depth.
B= 49 cm
C= 65 cm
D= 32 cm
E= 15 cm
F= 5 cm
container is 1.5
can be directly hung on to the steam sterilizer on the side
The attachment can be next to the steam sterilizer or above or below
the steam sterilizer
dem 47
Attachment next to the steam sterilizer or above or below the steam
sterilizer (e.g. lower cabinet)
delivered with water storage container
Danger of injury!
16
water may only be completed by a specialist technician.
Non-observance could lead to a short-circuit
damage and/or electrical shock. Serious injuries could be the
consequence.
Chapter 3 – Initial start-up
Electrical connection
Provide the following electrical connections for the steam sterilizer:
Connected load
2100 W
Cooling water inlet
A pressure hose is provided for connecting the cooling water inlet to a
customer
NOTICE:
In
leak monitor, e.g. water stop valve from MELAG (Art. No. 01056)
Cooling water discharge
The waste-water hose can be connected as follows:
The drain must be located below the
NOTICE:
The waste
For waste
a fixed laying of HT (high temperature) piping by a specialised installation
firm.
Observe the following precautionary measures when handling the
■ Never splice or modify the mains cable.
Insert power plug into the
Plug the power plug into the socket.
Electric circuit with 220V-240V and 50/60 Hz
16 A separate fuse protection – at least Automat Type B
Protection from leakage current 30 mA
-side faucet.
order to prevent water damage, MELAG recommends the use of a
.
On an existing rinsing drain when using the dual-chamber siphon
(Art. No. 26635) instead of the existing siphon
On a separate drain pipe when using the surface-mounted siphon
from MELAG (Art. No. 37410 – not in the standard scope of delivery)
steam sterilizer.
Danger of injury!
-water hose must be laid dip-free with continuous descent.
-water paths which are longer than two metres we recommend
mains cable and power plug:
■ Never bend or twist the mains cable.
■ Never pull on the mains cable to take it out of the socket. Always
take hold of the power plug itself.
■ Never place any heavy objects on the mains cable.
■ Never run the mains cable over places where it could be squeezed
(e.g. doors or windows).
■ Do not run the mains cable along a heat source.
■ Do not use any nails, staples or similar objects to fixate a cable.
If the mains cable or the power plug is damaged, turn off the steam
sterilizer. Mains cables or power plugs may only be replaced by
authorised persons.
If these points are not observed, the cable or plug can be damaged
and/or a fire or electrical shock might occur. Serious injuries could
be the consequence.
socket
17
Chapter 3 – Initial start-up
Prerequisites for initial start
The following prerequisites must be satisfied for initial start-up:
Record of installation and setting up
NOTICE:
As
as for your warranty claim, the record of installation must be filled out by
the person responsible and a copy sent to
Switch on
Switch on mains
Turn the mains switch on to power the steam sterilizer (page 11, Fig.
1
After switching on
After switching on the steam sterilizer with the mains switch, the
Unlocking door with button (+)
Directly after having switched on the steam sterilizer and before initial
start
-up
The cooling water inlet for the vacuum pump must be open.
The feed water supply must be secured.
The power supply of the steam sterilizer must be assured.
documentation of proper setting up, installation and setting up as well
MELAG.
steam sterilizer
/(4).
display shows in alternation to the initial state the message
, if the door is closed.
-up, remove the trays and accessories from the chamber.
Press the KEY (+) to unlock the door. After pressing the key you can
open the door
18
Chapter 4 – Sterilization
Chapter 4 – Sterilization
In this chapter you learn
Create prerequisites
You create the prerequisites for a smooth and successful sterilization
process as follows:
Provide cooling water
If the spigot for the cooling water inlet of the vacuum pump is closed,
open the tap.
NOTICE:
I
leak monitor, e.g. water stop valve from MELAG (Art. No. 01056)
Provide feed water
If you are employing a water storage container for the feed water and the
filling level lies below the MIN marker on the canister, f
storage
to
If you employ a water treatment unit
and the water feed is closed, turn it on. If the water storage tank of the
MELA
before the sterilization.
Switching on
If the steam sterilizer is still not switched on, switch it at the mains switch
(page
Prepare items to be sterilized
A significant prerequisite for safe disinfection and sterilization of
sterilizing materials is the appropriate preparation, i.e. cleaning and
maintenance of the sterilizing materials according to the manufacturer's
instructions. Furthermore the materials,
procedure employed are of significance.
Which prerequisites should be created for a smoothly-running sterilization What you should observe when preparing the items to be sterilized How to correctly load the steam sterilizer Which programs you should use for what How you start a program Which stages a program runs through How to cancel a program How to recognise when the sterilization is successfully finished What you can do to improve the drying results What you must consider when removing the items to be sterilized
n order to prevent water damage, MELAG recommends the use of a
.
ill up the water
container. The feed water must have a quality at least according
DIN EN 13060 (see page 39, Use qualitatively high-grade water)
, e.g. MELAdem 40 or MELAdem 47,
dem 47 is empty, turn the water feed tap on at least one hour
11, Fig. 1/(5)). (see as of page 18, Switch on steam sterilizer)
cleaning agents and processing
19
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