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.
Page 2
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.
Page 4
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
Page 5
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
Page 7
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
Page 8
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
Page 9
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
Page 10
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
)
Page 11
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
Page 12
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°.
Page 13
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
Page 14
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
Page 15
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
Page 16
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.
Page 17
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
Page 18
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
Page 19
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
Page 20
Chapter 4 – Sterilization
NOTICE:
If possible, sterilize textiles and instruments separately from each other in
separate sterilization contain
This way you achieve improved
Textiles
Observe the following instructions for treating textiles and putting
the textiles into sterilization containers:
■ Comply with the instructions of the textile manufacturer for treatment
Unsterile textiles
could be the consequence. This could mean endangering the health
Instruments
Observe the following instructions for treating used and brand new
instruments:
■Follow without fail the instructions of the instruments manufacturer
Clean the instruments very thoroughly, for instance with the help of a
ers or sterilization packages.
drying results.
Danger!
Danger of infection!
and sterilization and observe relevant standards and directives.
■ Adjust the folds of the textiles parallel to each other.
■ Stack the textiles in the sterilization containers vertically if possible,
and not too closely together, so that flow channels can form.
■Retain the vertical stacking method when you pack the textiles in
sterilization containers.
■If textile packages do not stay together, wrap the textiles in
sterilization paper.
■ Sterilize only dry textiles.
■ The textiles may have no direct contact to ground and walls of the
sterilization chamber, otherwise they absorb condensate.
in case of non-observance, the steam penetration of the textiles can
be obstructed and/or bad drying results can result.
of the patient and the practice team.
for treatment and sterilization, and observe the relevant standards
and directives of your country.
■
thermal disinfector.
■After disinfection and cleaning, rinse the instruments if possible with
demineralized or distilled water and subsequently thoroughly dry the
instruments with a clean, non-fuzzing cloth.
■Employ only cleaning materials which are suitable for steam
sterilization. Ask the manufacturer about the cleaning materials.
In case of non-observance, residual dirt can possibly be loosened
up during sterilization in the steam pressure. Rests of the
disinfection and cleaning agents lead to corrosion. Increased
maintenance requirements and impairment of the function of the
steam sterilizers can be the consequence.
Unsuitable cleaning materials, e.g. water-rejecting cleaning
materials or steam-impermeable oils, can result in unsterile
instruments. This endangers your health and the health of your
patients.
20
Page 21
Chapter 4 – Sterilization
When using the following devices, observe without fail the preparation
instructions of the instrument manufacturer:
Load the
Only if the steam sterilizer is properly loaded can the sterilization be
effective and the drying deliver good results.
NOTICE:
Use perforated
condensate run off.
items to be sterilized, you risk bad drying resu
use of tray insertions made of paper can perhaps li
drying results.
Wrapping
The correct use of suitable wrapping is important for the success of the
sterilization.
Warning!
Employ only packaging materials and -systems (sterile barrier
You can employ reusable rigid packaging such as standard tray
cassettes or soft packaging such as clear
paper bags, sterilization paper, textiles, fleece.
Closed sterilization -
Preferably use sterilization containers made of aluminium. Aluminium
conducts heat we
When using closed sterilization containers, observe the following
instructions for holding the sterilizing materials:
■Closed sterilization containers must be equipped at least on one side
observance leads to insufficient steam penetration which could
ge is prevented, and bad drying results are the consequence.
The sterilization containers from MELAG satisfy all requirements
according to DIN EN 868 for successful sterilization and drying. They are
perforated in the lid and floor and are equipped with disposable paper
filters.
Stack sterilization
Stack on top of each other, if possible, only sterilization containers of the
same size, where the condensate can run off on the side at the walls.
Ultrasonic units
Maintenance appliances for hand pieces and angle pieces
Cleaning and disinfection devices (e.g. thermal disinfector)
steam sterilizer
containers
Warning!
systems), which satisfy the DIN EN IS0 11607-1 Standard.
– possibly below – with perforations or valves.
Nonmake the sterilization ineffective. Furthermore the condensate
draina
This can ultimately lead to unsterile instruments and thereby to
endangering the health of the patient and the practice team.
trays, such as the trays from MELAG. Only this way can
If you use closed materials or shell halves to bear the
lts. Please note that the
kewise lead to worse
-plastic sterilization packages,
ll and thus accelerates drying.
containers
21
Page 22
Chapter 4 – Sterilization
■When stacking the sterilization containers, take care that the
vessel bottom. It would soak sterilizing materials lying underneath.
Soft sterilization packages
Soft sterilization packages can be sterilized both in sterilization
containers on trays or standing when using a package holder. When
using soft sterilization packages such as MELA
following instructions:
■Arrange the soft sterilization packages standing vertically at small
instruments and sterilize them once again. The packaging should be
g
Multiple wrapping
The steam sterilizer functions on the fractionated pre-vacuum method.
This permits the use of multiple wrapping.
Mixed loads
For sterilizing mixed loads, observe the following instructions:
Danger!
Warning!
perforations are not covered.
in case of non-observance, the condensate cannot drip off to the
The consequence would be bad drying results. This can ultimately
lead to unsterile instruments and thereby to endangering the health
of the patient and the practice team.
fol , observe the
intervals to each other.
■Do not place several soft sterilization packages flat on top of each
other on a tray or in a container.
■If the welding seam tears open during sterilization, then it might be
that the wrapping was too small. If this is the case, re-wrap the
filled to ¾ or the spacing for the sealing seam at 3 cm.
■If the welding seam tears open during sterilization, extend the sealin
cycle of the package sealing device or weld a double seam.
Non-observance can ultimately lead to unsterile instruments and
thereby to endangering the health of the patient and practice team.
Always place textiles on the top
sterilization containers at the bottom
unwrapped instruments at the bottom
Transparently wrapped sterilization packages and paper packaging
on the top – exception: in combination with textiles on the bottom
Stack clear plastic sterilization packages if possible edgewise in
such a way that alternately paper side lies on paper side and foil
side on foil side; if this is not possible, then with the paper side
facing downwards.
22
Page 23
Loading variants
Vacuklav 24 B+
Vacuklav 30 B+
Instruments
Textiles
Instruments
Textiles
Greatest weight per
2 kg
2 kg
2 kg
2 kg
Loading variant
max. 5 trays, depth 420 mm
max. 3 standard tray cassettes
max. 5 trays, depth 290 mm
max. 3 standard tray cassettes
Maximum total weight
7 kg
2.5 kg
5 kg
2 kg
*Mountings, trays, sterilization containers, norm-tray cassettes from MELAG, see Appendix A – Accessories
Close the door
When closing the door of the steam sterilizer, observe the following
instructions:
Select program
Select by rotating between the initial state and the desired program with
the program selection button (P).
Select the sterilization program according to how the items to be
sterilized are wrapped.
temperature of the items to be sterilized.
The following table shows which program to use for which items to be
steriliz
With the automatic pre-heating, the chamber of the steam sterilizer
before a program start is kept to the program
temperature or maintained at this temperature between two program
runs.
Prerequisite is that the
The condensate formation at the chamber
supported. The cycle times shorten.
The automatic pre
In order to change this setting if desired, proceed as follows:
134 ˚C134 °C 134 ˚C121 ˚C134 ˚C
Sterilization pressure 2.1 bar 2.1 bar 2.1 bar 1.1 bar 2.1 bar
Sterilization time 5.5 min. 5.5 min. 3.5 min. 20.5 min. 20.5 min.
Operating times
Operating time* 30 min. 28 min. 15 min. 40 min. 45 min.
Drying 20 min. 10 min. 5 min. 20 min. 20 min.
* without drying (full load) and depending on the load and installation conditions (such as the cooling water
temperature and supply voltage)
long, narrow-bore hollow bodies
instruments; simple hollow bodies
Prion-Program
7 kg/5 kg
1.5 kg
---
unwrapped
7 kg/5 kg
7 kg/5kg
Select the SETUP Menu Function by brief simultaneous pressing
of the KEYS (+) and (-).
The display shows Function: Last batch number.
Navigate with the KEY (+) or (-), up to the display
Function: autom. Pre-heating is displayed.
For confirmation press the KEY (P). The display shows the current
by pathologically-modified proteins is
suspected (e.g. Creutzfeld-Jacob, BSE)
-specific pre-heating
steam sterilizer remains continuously switched on.
wall is reduced and drying is
-heating is activated in the factory settings.
2.5 kg (24 B+)
2 kg (30 B+)
Goods
7 kg/5 kg
7 kg/5 kg
Page 25
Chapter 4 – Sterilization
Press the KEY (P) once again, switch the display to Pre-heating
NOTICE:
MELAG recommends the activation of automatic pre
Select additional drying
For difficult drying tasks you can extend the drying time of a program by
50% with the function Additional Drying.
For this proceed as follows:
The display shows
program sequence begins.
Start program
If you have selected a program with the program selection button, in
addition to
and whether the respective program for packaged or unpacked sterilizing
materials is suitable.
Unsupervised operation of electrical devices, including this
sterilizer at the
so ever for any damage resulting from unsupervised operation.
Press the KEY (S), in order to start the program.
The steam sterilizer checks the transport of the feed water and its
conductivity.
If
unwrapped instruments
Program is running
After the start of the program you can track the program steps on the
display. Chamber temperature and pressure as well as the duration until
the end of sterilization or the expired drying time is displayed.
Evacuation phase
In the Evacuation Phase (fractionation) air is evacuated repeatedly until a
program
the inflow of steam up to a slight overpressure.
Depending on selected program and the current chamber temperature at
program
Heating-up phase
The heating-up phase follows after the evacuation phase. The pressure
and the temperature climb with continual steam introduction in the
chamber until the sterilization parameters are reac
Program
Start-Stop
No. The pre-heating is deactivated.
In order to end the menu Function: autom. Pre-heating
and return to the initial state, press the K
EY (S) twice.
-heating.
When starting the program, simultaneously press the KEY (S) AND
KEY (+).
Supplement drying selected. Then the
WARNING
the selected program the sterilization temperature is displayed
operator’s risk. MELAG accepts no liability what
the Quick-Program S is started, the warning text Warning only
is shown on the display.
If the load exclusively contains unwrapped instruments, press the
Key (S) once again to confirm and start the program.
-dependent pressure is reached. This occurs in alternation with
start, additional fractionations are connected.
hed.
25
Page 26
Chapter 4 – Sterilization
Sterilization phase
After achieving the sterilization parameters of pressure and temperature,
the sterilization phase begins.
In alternation with pressure and temperature the remaining time of the
sterilization phase is also displayed.
A
end of the sterilization phase.
Drying phase
The drying phase begins after the pressure discharge.
The chamber is ventilated with simultaneous pressure compensation at
the end of th
The regular drying t
minutes
programs.
Manually terminate program
You manually terminate a running program in any of the phases.
IMPORTANT!
Do not interrupt a running program by disconnecting the power plug! In
case of non
when the
■Take heed that when opening the door after terminating a running
Manual termination before
If you terminate a program before the beginning of drying, then the items
to be sterilized are still unsterile.
To terminate the program, carry out the following steps:
"Stop"
NOTICE:
The confirmation prompt is shown for about 5 seconds on the display. If
the key is not pressed again, the program continues with the normal
process.
Depending on the point in time of the termination, a pressure discharge
or ventilation of the instrument is carried out. An appropriate display is
shown on the screen.
After the pressure discharge or ventilation is carried out, there is a
request for an
The screen
button
The message
alternation with the previously
Program
Start-Stop
pressure discharge with a corresponding display is carried out at the
e drying cycle.
ime is 10 minutes for the Quick-Program S is 5
, 10 for the Quick-Program B and 20 minutes for the all other
Danger of burning!
beginning of drying
-observance, an error message of power loss is displayed
steam sterilizer is switched back on.
program, hot water steam can escape out of the chamber,
depending on when the program was terminated.
■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.
■To remove tray cassettes, use a tray-lifter or gloves. The parts are
hot.
In case of non-observance, you can suffer burns.
Press the KEY (S).
Confirm the following prompt Stop program? Repeatedly press
with the KEY (S).
alternately displays Stop End and acknowledge with
’-’.
Press the KEY (-)
26
acknowledgement of the program termination.
Unlocking door with button ’+’ is displayed in
-selected program.
Page 27
Chapter 4 – Sterilization
After pressing the
(-) you can open the door.
A reference to
the logging printout.
Manual termination
In the drying phase you can cancel the program with the KEY (S).
You must then expect insufficient drying, especially for wrapped sterilized
items.
possible, always let sterilization programs with wrapped items continue
up to the end of the drying p
In a quick program, sterilized unwrapped instruments dry from their own
heat after removal from the
In the drying phase, the expired drying time is shown in alternation with
the message
To
The termination is confirmed with
NOTICE:
The confirmation
the key is not repeatedly pressed, the program continues with the normal
process.
After the ventilation of the chamber with a corresponding display text the
message
alternation with
If a printer or another output medium is connected to the
and the
stopped
Sterilization phase is finished
Sterilization phase
You can recognize on the display whether the sterilization phase has
successfully
The remaining time of the sterilization phase is displayed in alternation
with the specification of the pressure and temperature.
Sterilization not successfully
The sterilization is not successful if it was terminated by the operator or
aborted by the system in the event of an error.
Program abort by the system
At a system abort, the system puts the chamber into a pressureless
state.
NOTICE:
If the program
the program is aborted by the system, an error message is displayed.
KEY
Program stopped/ load not sterile is issued to
during drying
Sufficient drying is a prerequisite for sterile storage. Therefore, if
hase.
steam sterilizer.
Immed. Removal Press "Stop" is displayed.
terminate the program, carry out the following steps:
Press the KEY (S).
Confirm the following prompt Stop program? Repeatedly press
"Stop" with theKEY (S).
Drying stopped on the display.
successfully finished
finished
prompt is shown for about 5 seconds on the display. If
Universal-Program run successfully follows in
Last batch number. xx and quit with ’+’.
steam sterilizer
Immed. Output is set to yes, a reference to Drying
is issued to the logging printout.
completed.
is terminated by the operator, a warning text appears. If
27
Page 28
Chapter 4 – Sterilization
Drying phase
The steam sterilizer does an excellent job of drying the items to be
sterilized.
necessary to take the following measures to further improve drying:
Improve drying results
Load the steam sterilizer correctly for drying. Place items wrapped in
Program is finished
The chamber pressure is adapted to the ambient pressure at the end of a
program.
the program was successfully finished, an appropriate notification
appears on the display.
Immediate printout
The report of the completed program is issued to the selected output
medium for activated
Logging
Display
Display last batch number
After every completed program you automatically see on the display the
last batch number of the day. This is also shown if the program was
terminated by the operator or aborted by the system.
You can also allow the display of the last batch number whenever
necessary:
In order to reach the starting position again, press the
You can allow the display of the number of total batches.
Select the SETUP Menu Function by short simultaneous pressing
You see the current counter reading of
display
In the event of difficult drying tasks it might however be
sterilized clear plastic or paper upwards like filing cards.
Observe Section
employ the package holder.
Activate the function Supplement Drying. Observe the Section
Select additional drying on page 25.
An appropriate display message Ventilation is shown. If
Load the steam sterilizer on page 21. Possibly
immediate output (see page 30, Chapter 5 –
).
batch number
Select the SETUP Menu Function by short simultaneous pressing
of the KEYS (+) and (-). The display shows Function: Last batch number.
Press the KEY (P) to display the current batch number of the day.
KEY (S) twice.
of the KEYS (+) and (-). The display shows Function: Last batch number.
Navigate with the KEY (+) or (-), up to the display where the
submenu Batch counter is shown.
Press the KEY (P).
the total batch number on the
In order to reach the starting position again, press
EY (S) twice.
the K
28
Page 29
Chapter 4 – Sterilization
Remove sterilized items
After the end of a program observe the following instructions for removing
■Check the wrapping of the sterilized objects for damage when
observance can result in unsterile instruments. This endangers
Open door
After the end of a program, the request Quit with button ’+’) is
displayed. Press the
audible, you can open the door and remove the sterilized items.
For connected printer and
is addit
output
Condensate residues on the
If you remove the sterilized items from the steam sterilizer directly after
the end of the program, it can happen that slight quantities of condensate
moisture are found on the sterilized items.
S
the paper bags and clear plastic sterilization packages are
unobjectionable if they dry out within 30 minutes after removal from the
steam sterilizer
Storage of sterilized items
Exclusively employ packaging which complies to standards for the
sterilized materials. Do not store sterilized items in the preparation room.
For the storage of the sterilized items, observe the criteria mentioned
below.
Storage conditions
■ Sealed against dust e.g. in a closed instrument cabinet
■
■
■
Storage duration in accordance with the type of package wrapping
Storage time
The maximum storage life depends on the packaging and the storage
conditions.
with the standards (dust
is up to six months.
the sterilized items:
Danger of burning!
Danger
■Never open the door by force. The steam sterilizer could be
damaged and/or hot steam could escape.
■ 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.
In case of non-observance, you can suffer burns.
removing them from the steam sterilizer.
■If a wrapping is damaged, wrap the object again and re-sterilize it.
Nonthe health of the patient and the practice team.
sterilized items
KEY (+) to unlock the door. After unlocking the door
Immediate Output Yes a logging printout
ionally carried out (see page 34, Automatic immediate log
.
maller quantities of water which may be are found on the upper side of
.
Protected from damage on smooth surfaces
Protected from excessive fluctuations in temperature
Protected from moisture (e.g. alcohol, disinfectant)
For sterilized items which have been wrapped in compliance
-protected storage is assumed) – this time period
29
Page 30
Chapter 5 – Logging
Chapter 5 – Logging
In this chapter you learn
Batch documentation
The batch documentation is indispensable as documentation for the
successfully completed sterilization process and as an obligator
measure of
The data, such as type of program as well as batch and process
parameters of the completed programs, are stored in an internal log
memory of the
For the batch documentation you can transfer the internal log memory
readout and the data onto diverse output media. This can take place
immediately after every completed program or subsequently, e.g. at the
end of a work day in the practice.
Capacity of the internal
The capacity of the internal storage suffices for about 40 logs.
If the internal log memory is full, when starting the next program the
respectively oldest report is automatically overwritten.
If you have connected a printer and additionally the option
output
output
overwritten. For additional information on connecting the printer, see
page
Output media
You can store the logs of the completed programs on the following output
media and archive them accordingly.
Log printer MELAprint 42
*
For
duration
instructions.
State on initial delivery
No option for the output of the logs is set in the initial delivery state of the
steam sterilizer
media.
Why and how you document batches Which output media you can employ for the batch documentation in which way How to read the logs correctly How to set the date and time at the steam sterilizer
y
quality assurance.
log memory
steam sterilizer.
immediate
is set to No (see also Page 34, Automatic immediate log
), a confirmation prompt appears before the saved record is
31, Connect printer.
MELAflash CF card Printer on CF card
Computer, e.g. with software MELAtrace/MELAview* MELAnet Box
From device version 5.11 is the software version MELAview 3 required.
further information of the protocoll printer (for example for the
of for the log printouts) please refer to the respective operating
30
. You can read below how to output the logs on the cited
Page 31
Chapter 5 – Logging
Set date and time
Observe time re-settings
Date and time of the steam sterilizer must be correctly set for proper
batch documentation.
("daylight saving time"), since this is not reset automatically. Set date
and time as described below:
Select the SETUP Menu Function by short simultaneous pressing
The display shows
The
The current preset value on the display no longer blinks
In order to adjust the other parameters,
On the display, the
By pressing the key (S) again you leave the menu completely and the
display again shows its starting pos
Use printer as output medium
If you want to employ the printer MELA
connect it to the
Data connection
Open the white cover of the serial data- and printer connection (see page
11
(1)
(2)
Turn a coin by a quarter-revolution inserted in the locking slot (1) on
If the printer or a computer is continually connected to the
sterilizer
ducts (2), the metal casing retracted and the cover is closed again. This
provides a comfortable external cable connection to the printer.
Connect printer
Observe the time re-settings in autumn and spring
of the KEYS (+) and (-).
Function: Last batch number.
Navigate with the KEY (+) or (-) in the Menu Function, up to the
display Function: date/ time are displayed.
Press the KEY (P) in order to confirm. The current hour is displayed.
Select between the following setting possibilities with the KEY (+)
or (-): Hour, minute, second
Day, month, year
In order to adjust the hour parameter, press the KEY (P) for the
confirmation.
current value on the display blinks.
The value can be increased or reduced with the KEYS (+) and (-).
In order to store the value, confirm with the KEY (P).
proceed analogously.
After finishing the settings, press the KEY (S) in to leave the menu
Function: Date/Time are again displayed
from the steam sterilizer
, Fig. 1/ (6)):
the white cover.
Take cover off and fold the interior metal casing to the left.
Press the metal casing somewhat downwards until it engages and
no longer can automatically flip back.
Connect the cables of the log printer to the printer connection at the
steam sterilizer.
, the data connection cable of the log printer is laid in the cable
ition.
print 42 as the output medium,
steam sterilizer as follows:
steam
31
Page 32
Chapter 5 – Logging
Close the log printer MELAprint 42 according to the pertinent operating
manual.
Initialisation of the log
In order to be able to print out logs on the connected log printer, you
must initialise MELA
steam sterilizer
Test outputs on the
In order to verify the functional reliability of the log printer MELAprint 42
and its communication with the
carried out:
Select the SETUP Menu Function by short simultaneous pressing
printer
MELAprint
42
log printer
MELAprint 42
print 42 once by making the following setting at the
:
If the steam sterilizer is still not switched on, switch it on.
Wait until the display shows the basic settings (page 13, Control
Panel)
Select the SETUP Menu Function by short simultaneous pressing
of the
KEYS (+) and (-).
The display shows Function: Last batch number.
Navigate with the KEY (+) or (-) until the display Function: Batch
output is shown.
Press the KEY (P). to select the submenu Batch output –
Output medium.
Press the KEY (P) again. The display shows Output medium – No
Output medium, in case no printer was yet selected.
Navigate with the KEY (+) or (-), until the display
shows as output medium MELAprint.
For confirmation press the KEY (P). The display changes back to the
menu Batch output – Output medium.
Press the KEY (S), in order to return to the menu Function:
Batch output.
After renewed pressing of the KEY (S) the display again shows the
initial state.
steam sterilizer, a test output can be
of the keys (+) and (-).
The display shows Function: Last batch number.
Navigate with the KEY (+) or (-) until on the display Function:
Batch output is shown.
Press the KEY (P) to select the submenu Batch output –
Output medium is displayed and press the KEY (P) for
confirmation.
Navigate with the KEY (+) or (-) until the display Test output is
shown.
In order to start the output, press the KEY (P).
An appropriate display with Test output appears.
In order to break cancel the test output or leave the menu after
finished printout, press the K
Batch output.
By again pressing the KEY (S), you completely leave the menu and
return to the starting position of the display.
32
EY (S). The display shows Function:
Page 33
Chapter 5 – Logging
Employing
The MELAflash CF card Printer serves for storage of sterilization logs on
the MELA
practice computer is carried out with the MELA
Additionally you can use the software MELA
logged data.
TIP
You can download a current version of the software on the internet page
of MELAG
Connect the MELA
log printer MELA
output medium
You will find detailed information in the operating manual for the
MELA
NOTICE:
Naturally you can also allow the MELA
connected permanently to the
MELA
MELA
The MELAnet Box enables the connection of the steam sterilizer with a
real ethernet interface to the computer network of the practice or clinic.
The logs which are created during a program run can be saved by means
of a FTP server or over TCP via the MELA
In the MELA
displays status information of the connected
for the MELA
of the current progress of a program cycle or current measured values.
Connect the MELAnet Box with the serial interface like the log printer
MELA
medium
You will find detailed information in the operating manual for the
MELA
Computer as output medium
Initialisation of the
In order to be able to employ a computer as output medium, the
computer must be connected with the serial interface to the
sterilizer
readout.
In order to register the computer at the steam sterilizer, proceed as
described on page
Observe that f
must make the setting
MELAflash as output medium
flash CF card. The readout of the logs from the CF card to the
flash card reader.
view for processing the
on www.MELAG.de in the download area.
flash CF card Printer with the serial interface like the
print 42 (see page 31). and set at the steam sterilizer as
MELAflash in the SETUP Menu.
flash CF card Printer itself.
steam sterilizer like the log printer
print 42.
flash CF card Printer to be
net Box as output medium
net Box on the computer.
net Box there runs a small webserver program, which
steam sterilizer and settings
net Box via a webbrowser. Thus you can allow the display
print 42 (see page 31) and set at the steam sterilizer as output
MELAnet in the SETUP Menu Function.
net Box itself.
computer
. Additionally the software MELAview can be installed for the log
or the output medium in the SETUP Menu Function you
steam
32, Initialisation of the Log Printer.
Computer.
33
Page 34
Chapter 5 – Logging
Automatic immediate log output
If you immediately would like to output the associated report
automatically on an output medium after the end of a program, use the
function
delivery state.
Prerequisite for
The following prerequisites must be satisfied for the immediate log output
after the end of a program:
This sets the option for an immediate output of the logs after the end of
the program:
In order to save the setting and to leave the menu again, press the
(S). The display shows
NOTICE:
If it is not possible to output a log report for the immediate output
because for example the activated output medium is not connected, a
warning
immediate output of logs.
Output the logs
You also have the option of outputting the logs subsequently and
independently from the time of the end of the program. You can select
whether selected or all saved logs (up to 40 logs) should be printed.
For this, use the connected output medium, e.g. the log printer.
Print selected logs
In order to subsequently print selected logs of certain programs, proceed
as follows:
Immediate output Yes. This is not preset in the initial
automatic
immediate output of the logs
after the end of the program
As output medium the computer, the log printer MELAprint 42 or
another output medium must be connected and initiated.
Switch the steam sterilizer on with the power switch.
Select the SETUP Menu Function by short simultaneous pressing
of the KEYS (+) and (-). The display shows Function: Last
batch number.
Navigate with the KEY (+) or (-) until on the display Function:
Batch output is shown and press the KEY (P).
Navigate with the KEY (+) or (-) until on the display the submenu
Immediate output Yes/No is shown.
Press the KEY (P), in order to switch between Immediate output
No and Immediate output Yes.
In order to output logs immediately, Immediate printout Yes
must be set.
KEY
Function: Batch output.
By again pressing the KEY (S), you leave the menu completely and
return back to the initial state.
message appears. MELAG recommends that you employ the
34
Select the SETUP Menu Function by short simultaneous pressing
Navigate with the KEY (+) or (-) until on the display Function:
The Menu Batch output – Output medium is displayed.
Navigate with the KEY (+) or (-) until the display
of the keys (+) or (-). The display shows Function: Last batch
number.
Batch output is shown and press the KEY (P).
Last cycle output: No. 40 is shown (as example No. 40).
subsequently
Page 35
Chapter 5 – Logging
Press the KEY (P). The current report number blinks.
After finished printout, the display changes again to its previous setting
Last cycle output: No. 25
Output all saved logs
In order to subsequently output all saved logs, proceed as follows:
After finishing the output the display again shows
cycles
NOTICE:
A termination
disconnecting the instrument at the mains switch or interrupting the
power supply of the printer.
In order to leave the menu, likewise press the KEY (S). The display
Delete stored logs
I n order e.g. to suppress the warning text Protocol memory full for
preset option
deleted.
In the following example you can read how you can delete all saved logs.
Select the SETUP Menu Function by short simultaneous pressing
Function: Batch output
Program
Start-Stop
In order to output a log of another cycle, navigate with the KEYS (+)
or (-) up to the desired number, here e.g. 25.
Press the KEY (P) in order to start the output of the selected
program. The display shows Output.
.
In order to output additional logs, repeat the last three steps.
In order to leave the submenu without outputting, press
EY (S).
the K
In order to leave the menu after the output, press the KEY (S). The
display shows the menu Function: Batch output.
By again pressing the KEY (S), you completely leave the menu and
return back to the basic position of the display.
Select the SETUP Menu Function by short simultaneous pressing
of the keys (+) or (-). The display shows Function: Last batch
number.
Navigate with the KEY (+) or (-) until on the display Function:
Batch output is shown and press the KEY (P).
Navigate with the KEY (+) or (-), until the display
Output stored cycles is displayed.
Press the KEY (P) in order to start the printout of the selected
program. The display shows Output.
Output stored
.
In case you would like to leave the submenu without printing, press
EY (S)
the K
during the output on the log printer is only possible by
shows the setup menu Function: Batch output.
By again pressing the KEY (S), you completely leave the menu and
return to the starting position of the display.
Immediate output No, the saved logs can be manually
of the keys (+) and (-).
The display shows Function: Last batch number.
Navigate with the KEY (+) or (-) until on the display Function:
Batch output is shown and press the KEY (P).
Navigate with the KEY (+) or (-) until on the display All cycles
delete is shown.
Press the KEY (P) in order to delete all logs now.
In order to cancel the submenu without deleting, press the KEY (S).
In order to leave the menu after deletion, press the KEY (P). The
display shows
.
35
Page 36
Chapter 5 – Logging
By again pressing the KEY (S), you completely leave the menu and
Display
With a connected and initialised printer or another output medium you
can verify how many logs are already saved in the log memory of the
steam sterilizer
Proceed as follows:
Read log files correctly
Header
The head of the program listing includes the general fundamental
information for the completed program such as for example current date,
the selected program, the daily batch number and the
type.
Values of the program steps
During the program the program sequence phases are recorded with the
accompanying values for steam pressure, temperature and time (relative
to the program start).
Summary
The summary states whether the program was successfully concluded.
Furthermore the values of the
temperature and the pressure including its maximum deviations are
displayed.
Program
Start-Stop
return to the starting position of the display.
protocol memory
.
Select the SETUP Menu Function by short simultaneous pressing
KEYS (+) and (-). The display shows Function: Last
of the
batch number.
Navigate with the KEY (+) or (-) until on the display Function:
Batch output is shown and press the KEY (P).
Navigate with the KEY (+) or (-), up to the display for the Storage
Occupancy (see left Display Figure) are shown.
In order to leave the menu again, press the KEY (S) twice.
steam sterilizer
required sterilization time, the sterilization
36
Page 37
Chapter 5 – Logging
------------------------------------------
------------------------------------------
Header
Program : Universal program
134°C Packaged
Started program
Date : 27.03.2015
Current date
Start 0.00 25.2 00:00
Values of the program steps
Program sequence phases with the accompanying
values for pressure, temperature and time (relative
------------------------------------------
Summary
Program properly executed!
Control message
Temperature : 135.8 +0.4 /-0.3 °C
Mean sterilization temperature with max.
26 201501150 5.15 5.05
Information with total-cycle counter, factory serial
MELAG Vacuklav 24-B
Time of day : 08:36:39 (Start)
Batch number: 10
SN : 201524-B1150
Time at program start
Daily batch number
Serial number
Preheating temperature
conductivity of the feed water
to the program start)
Pressure : 2.17 +0.03/-0.03 bar
Sterilizate time: 5 min 30 s
Time of day : 09:19:06 (End)
==========================================
deviations
Mean sterilization pressure with max. deviations
Sterilization time maintained
Time at the end of the program
number and instrument software version no.
37
Page 38
Chapter 6 – Maintenance
Chapter 6 – Maintenance
In this chapter you learn
Cleaning
Weekly inspection of
Examine the chamber including door seal and chamber sealing surface
and the mounting for loading (page
weekly for contaminants, deposits or damage.
In case of contaminations
If you determine any contaminations, draw the existing trays or cassettes
and the
contaminated parts.
Door seal
The door seal must not be greased or oiled. It should be kept clean and
dry.
When cleaning the chamber, the loading mounting, the chamber
First drench the cloth with cleaning alcohol or methylated alcohol and
Housing parts
Clean the housing parts with neutral liquid cleaners or methylated
alcohol.
External water storage
Regularly clean the external water storage container depending on the
light incidence, ambient temperature and consumption. In order to
prevent microbe and algae contamination, this cleaning should be done
at least once per month.
Empty the container and clean it with about three litres of warm tap
water,
brush. Rinse with abundant tap water at least twice.
How to clean the steam sterilizer and which cleaning agents are suitable How to avoid the formation of spots How to exchange the door seal What to observe in steam sterilizer maintenance
chamber, door seal,
mounting, chamber sealing
surface
associated mounting forwards out of the chamber. Clean the
Warning!
sealing surface and the door seal, observe the following:
■Switch the steam sterilizer off before cleaning and pull the power
plug from the wall socket.
■ Make sure that the chamber is not hot.
■ Use a soft and lint-free cloth.
■ Use chlorine- and vinegar-free cleaning agents.
■
try to wipe off the contamination.
■In case of persistent soiling of the chamber, mounting or chamber
sealing surface, employ only a mild stainless steel cleaning agent
with a pH value between 5 and 8.
■ Employ neutral liquid cleaning agents to clean the door seal.
■ No cleaning agents may get into the piping system which exits the
steam sterilizer chamber.
■Do not use any rough objects such as pot cleaners made of metal or
steel brushes.
In case of non-observance the cleaned surface could become
scratched or damaged and the sealing surfaces not tight. This
would promote dirt deposits and corrosion in the sterilization
chamber.
21, Load the Steam sterilizer) once
container for feed water
38
to which you add a neutral cleaning agent, and use a suitable
Page 39
Chapter 6 – Maintenance
To conclude the cleaning, rinse the water storage container without fail
with a litre of feed water.
Avoid formation of spots
Formation of spots due to
Only if you correctly clean the instruments before sterilization can you
avoid the detachment of residues resulting from loading or instrument
preparation under steam pres
residues (e.g. residues of disinfectants) can clog the filter, nozzles and
valves of the
discolorations on the instruments and in the chamber (
Prepare items to be sterilized
Formation of spots due to
All steam-conducting parts of the steam sterilizer are made of non-rusting
materials. This excludes the formation of rust caused by the
sterilizer
rust.
If the instruments have been incorrectly prepared, rust can form even on
stainle
producing instrument already suffices for third
other instruments or in the
Remove third
s
damaged instruments to the manufacturer for reconditioning.
Formation of spots due to
feed water
The extent of the formation of spots on the instruments also depends on
the quality of the feed water employed for steam production.
Use qualitatively high
Observe the following when using feed water for the steam sterilization:
DIN EN 13060,
NOTICE:
Feed water which you can produce with the osmosis
with the ion
feed water.
improperly cleaned
instruments
third-party rust
inadequate quality of the
Warning!
sure during the sterilization. Detached dirt
steam sterilizer and deposit as stains, spots or
see page 19,
).
steam
. Should rust stains occur, then we are dealing with third-party
ss steel instruments of leading manufacturers. Often a single rust-
-party rust to form on the
steam sterilizer.
-party rust from the instruments with a chlorine-free
tainless steel cleaning agent (see page 38, Cleaning) or send the
-grade feed water
■Use only demineralized or distilled water according to
appendix C.
In case of non-observance, stains or damage on the instruments
can arise and the functional readiness of the steam sterilizer can be
adversely affected.
exchanger MELAdem 40, satisfies the requirements on the
unit MELAdem 47 or
39
Page 40
Chapter 6 – Maintenance
Replacing
The door seal may not be greased or oiled. It should be kept clean and
dry. If the door seal becomes worn and looses form, it must be replaced.
Otherwise, this could result in leaks which will enable steam egress, or
too high a leakage rate in the vacuum t
Proceed as follows to replace the door seal:
IMPORTANT!
Observe without fail the different widths of the sealing surface. Only
with correct seating in the groove is a proper closing of the door
guaranteed and the chamber tight.
Aligning the
Long periods of storage with the door closed can result in the sealing lips
of the door seal becoming stuck. Align the sealing lips to prevent leaks.
Proceed as follows:
Remove the door seal.
the door seal
est.
Open the sterilizer door and remove the old door seal. The door seal
is now inserted in the groove of the round blank (Fig. 2/(6)). Insert
the new door seal in the groove in such a way that the wider seal
face points towards the chamber side.
door seal sealing lip
40
Page 41
Chapter 6 – Maintenance
Press your thumb between the two sealing lips and separate the
PLEASE NOTICE
Note the differences in the widths of the sealing surfaces
the door seal. The door can only be shut correctly and the chamber
sealed, if the door seal sits correctly in the groove.
Changing
Remove the sterile filter by turning and pulling it from the holding
sealing lips once around with your thumb.
Insert the door seal into the groove. The wide sealing surface points
towards the chamber.
sockets simultaneously.
when inserting
the sterile filter
41
Page 42
Chapter 6 – Maintenance
Sterilizing the sterile filter
Replace the sterile filter or sterilize the current sterile filter as
described under the point "Sterilizing the sterile filter".
Exert a little pressure on the sterile filter and turn to insert it into the
holding sockets.
Remove the sterile filter by turning and pulling it from the holding
sockets simultaneously.
Slide a perforated tray into the steam sterilizer and place the sterile
filter vertically on the tray. Ensure that the sterile filter does not fall
over, otherwise the condensate will not be able to drain away
correctly.
Start the Gentle-Program.
Remove the sterile filter from the device after the program end and
allow it to cool for min.
15 minutes.
Exert a little pressure on the sterile filter and turn to insert it into the
holding sockets.
42
Page 43
Chapter 6 – Maintenance
Cleaning the filter in the chamber
Unscrew and remove the filter (anti-clockwise) from the opening to
Fig.
(a) Condensate reflux filter
(b) Chamber filter
(c) Wrench for the chamber filter
Maintenance
■ Have maintenance carried out only by trained field service
For retention of value and
Regular maintenance is indispensable for the retention of value and the
reliable practice operation of the
During maintenance, all functional and safety
electrical facilities are checked, and replaced if necessary. The
maintenance is carried out according to the maintenance instructions
which are relevant for this
Maintenance intervals
Regularly allow for maintenance after each 1000 program cycles or two
years.
PLEASE NOTE
National pressure vessel requirements may ask the user of pressure
vessel, such as
check the download area from our website and find our recommendation
in accordanc
local authorities.
a b c
check and clean it.
Rinse the filter with water to clean.
Screw in the filter into the opening in a clockwise direction.
Unscrew the chamber filter (Fig. 6/(6)) using the chamber filter
wrench included in the scope of delivery.
6: View of the interior of the chamber
technicians or technicians of the specialist trade. Turn to your
Warning!
functional reliability
specialist dealers or MELAG customer service in your vicinity.
■Comply with the predetermined maintenance intervals.
Malfunctions at the steam sterilizer can occur on continuation of
operation despite the servicing message.
steam sterilizer.
-relevant components and
steam sterilizer.
e with German requirements. For more information ask your
steam sterilizers, to carry out safety inspections. Please
43
Page 44
Chapter 7 – Operating pauses
Chapter 7 – Operating pauses
In this chapter you learn
Sterilization frequency
No pause times
Pause times between individual programs are not required, since the
sterilization chamber is permanently maintained at the required
temperature.
After the expiration or termination of the drying time and removal of the
items to be sterilized, you can imme
and start a program.
Pause times
Longer operating pauses
Switch the steam sterilizer off for longer operating pauses, e.g. overnight
or on the wee
protected from premature wear. Furthermore it prevents
the door seal.
Close the cooling water inlet and, if available, the water feed of the water
treatment unit.
After operating pauses which last longer than two weeks, carry out a
vacuu
(see page
The following situations can occur after longer pauses:
Event
Possible cause
What you can do
conductivity too high
Bad feed water
Change the feed water or the mixed-bed-resin
Door cannot be opened
Door seal is sticking to the
Switch the steam sterilizer on and pull
Warning text:
Liquid seal pump faulty
It is necessary to turn the vacuum pump.
Function test after pauses
After pauses, carry out the tests described in Chapter 8 Functional Tests,
depending on the pause duration.
How quickly you can start sterilization programs in sequence What you must observe for longer operating pauses How to put the steam sterilizer out of operation, transport it and re-start it
required
Warning no cooling water/
check tap water
m test and thereafter an empty sterilization with the Quick Program
sealing surface
diately re-load the steam sterilizer
kend, and leave the door ajar. The door seal is relieved and
the sticking of
46, Chapter 8 – Function test)
pellets for a MELAdem unit.
vigorously at the door to open it.
Follow the instructions in the Technical Manual.
44
Page 45
Chapter 7 – Operating pauses
Shut-down
If you would like to shut down the steam sterilizer (put it out of operation)
for a longer period of time, for instance because of holidays or a planned
transport, proceed as follows:
Transport
Observe the following when carrying the steam sterilizer:
Observe the following when transporting the steam sterilizer, e.g.
When using a water treatment unit, close the water feed and removal
Re-startup after change of locality
At re-startup of the steam sterilizer after a change of locality, proceed as
for an initial start
Switch the steam sterilizer off at the mains switch.
Pull the power plug from the wall socket.
Close the cooling water inlet and, if available, the water feed of the
water treatment unit.
Danger of injury!
Warning!
■ Two people are necessary to carry the steam sterilizer.
■ Use a suitable carrying strap to transport the steam sterilizer.
Observe that the spacing between the underside of the housing floor
plate of the steam sterilizer and the footprint is small.
In case of non-observance spine damage and contusions can result.
when moving or shipping the steam sterilizer or for the transport
within the practice:
■
the hose connections at the rear of the device.
■If you would like to leave the mounting and the trays or cassettes in
the chamber during transport, protect the surface of the door plate.
Lay a piece of foam plastic or bubble wrap between the door plate
and mounting.
■Close the door of the steam sterilizer before you move the device.
In case of non-observance, damages to the steam sterilizer and
errors can occur.
-up (see page 15, Chapter 3 – Initial start-up)
45
Page 46
Chapter 8 – Function test
Chapter 8 – Function test
In this chapter you learn
Automatic function test
Process evaluation and
The interaction of the sterilization-relevant parameters of pressure,
temperature and time are continually automatically monitored by the
electronic parameter control.
The process evaluation system of the
process parameters w
them with respect to their limit values.
The monitoring system of the
components with regard to their functional reliability and their plausible
interaction. If the paramet
sterilizer
aborts the program with a corresponding notice.
If the program was successfully concluded, an appropriate message is
issued on the display.
Manual function test
You can track the program sequence based on the values shown on the
display. Furthermore on the basis of logs made for every program, you
can logically reconstruct whether a program was successful (see page
Chapter
How the steam sterilizer automatically carries out the function test Which possibilities you have for the manual function test Which function tests should be conducted in daily operation Why and how you should conduct a vacuum test Why and how you should conduct a Bowie & Dick test How you carry out batch-related tests How you display the water quality
monitoring system
steam sterilizer compares the
ith each other during the program and monitors
steam sterilizer checks the device
ers exceed defined limit values, the steam
outputs warning messages or error messages. If necessary, it
30,
5 – Logging).
46
Page 47
Chapter 8 – Function test
Testing in daily operation
Vacuum test
Weekly in routine operation,
Conduct a vacuum test in the following situations:
The test serves to determine leaks in the
The leakage rate is determined.
Conduct the vacuum test with a cold and dry steam sterilizer as follows:
Switch the device on at the mains switch. The display switches into
Press the KEY (P) until the menu Vacuum test is shown in the
The chamber is evacuated until the pressure for the vacuum test is
achieved. An equilibration time of five minutes and a meas
of ten minutes follow. The rise in pressure in the chamber is measured
within the measurement time.
The evacuation pressure and the equilibration time or measurement time
are shown on the display.
After the expiration of the measurement time, the chamber is ventilated
(appropriate display message).
Subsequently the message with specification of the leakage rate is
shown on the display. If the leakage rate is too high, i.e. above
mbar, an appropriate message appears on the display.
Besides the display shows in alternation with the current batch number of
the day and
can open the door.
NOTICE:
For connected log printer or another output medium and the setting
Immediate output Yes
printout
Bowie & Dick test
The Bowie & Dick test serves the verification of the steam penetration of
porous materials such as
Diverse test systems are offered by specialist dealers for the
Dick test.
the test system.
Start the program Bowie & Dick test as follows:
at initial start-up, after
pauses longer than two
weeks and in case of error
Once weekly in routine operations
At initial start-up
After longer operating pauses
In case of a respective error (e.g. in the vacuum system)
steam sterilizer.
its initial state.
display.
Close the door. This is confirmed with the appropriate display Door
closed.
Press the KEY (S), in order to start the vacuum test.
urement time
Quit with button ’+’. After pressing the KEY (+) you
.
Conduct the test according to the manufacturer's instructions of
Switch the device on at the mains switch. The display switches into
its initial state.
Select the Bowie & Dick test with the KEY (P).
Press the KEY (S) to start the Bowie & Dick test.
≤ 1.3
logging is carried out with simultaneous
textiles.
Bowie &
47
Page 48
Chapter 8 – Function test
After successful completion of the program the display shows in
Quit with
button ’+’
Helix test
Batch-related tests
The test specimen system MELAcontrol /PRO is an indicator and batch
monitoring system which satisfies the standard DIN EN 867
of a test specimen, the helix, and an indicator strip.
If you sterilize instruments of the category "Critical B", the MELA
/PRO
sterilization cycle.
Independent of this you can at all times conduct a steam penetration test
with the MELA
The proper use of the Helix test body as directed can nevertheless
in a discoloratio
no influence on the functional capability of the Helix test body.
Display water quality
You can at all times have the display of water quality shown on the
switched on the
To do this keep the
Conductivity. The conductivity is stated in µS/ cm.
As soon as you release the
status (e.g. initial state).
Pre-heating temperature of
If you press the KEY (-) twice shortly and the second time keep it pressed,
the pre
Conductivity.
alternation with the current batch number of the day and
. After pressing the KEY (+) you can open the door.
body system MELAcontrol /PRO
-5. It consists
control
test specimen should be included as a batch control for every
control / PRO in the universal program.
result
n of the plastic surface. However, this discoloration has
steam sterilizer, also during a running program.
KEY (-) pressed until the display shows the
KEY (-)the display returns to its previous
the chamber
-heating temperature of the chamber is shown instead of the
48
Page 49
Chapter 9 – Errors
In this chapter you learn
A warning is not an error
Not all messages which appear on the display are error messages.
Warning messages
Warning messages are displayed when necessary. Warning messages
are not error messages. They help to ensure smooth operation and to
recognize undesirable conditions. Observe these warning messages
promptly in order to avoid errors.
Error message
Error messages are displayed if safe operation or sterilization security is
not guaranteed.
These can appear on the display shortly after switching on the
sterilizer
The program is aborted if a malfunction occurs during a program run.
■If a program is aborted during the sterilization phase, the load is
The error message is then shown on the display. in alternation with the
current program phase (
End
on the display in alternation with the
button
’
press the
Which type of messages existWhat you should do in case of errors What you can do before calling the Hotline What you can do if no display appears What you can do when the feed water consumption is too high What you can do if there are bad drying results
Chapter 9 – Errors
Danger of infection!
steam
or while a program is running.
unsterile. Repackage and repeat the sterilization for the respective
items to be sterilized.
Non-observance endangers the health of your patients and the
practice team.
pressure discharge, Ventilation or
) After the program abort or termination, the error message is shown
message acknowledge with
-’ and Program stopped. In order to delete the error message,
KEY (-).
49
Page 50
Chapter 9 – Errors
Before you call
Follow the operating procedures shown in connection with a warning text
or an error message on the display of the
the most important events in the following table. Possible causes and
appropriate operating instructions are
If you do not find the event in the table below or your efforts do not lead
to success, turn to your specialist dealer or the authorised MELAG
customer service centre in your vicinity. In order to help you, keep the
serial numbe
the fault report ready.
Warning message
Possible causes
What you can do
Warning: Door open /
Door switch is not closed on start
Push the sliding closure grip until the stop
Warning: No cooling
Faucet not opened
Check cooling water inlet, open faucet
Warning: No feed
Feed water supply from external storage
steam sterilizer. You will find
listed for the events.
r of your steam sterilizer and a detailed fault description of
No start possible
water/ Check tap water
water/
check feed water supply
Water pressure provided by the
customer too low
Protective motor switch has
triggered
Vacuum pump seized after longer
idle time
Too little or no water in the
storage container
Intake hose bent
Suction level too high (max.
suction height 1.5 m from the
bottom of the external water
storage container to the intake
stub of the steam sterilizer
Suction filter of the external water
storage container clogged
downwards. Correct display: Door closed
Check cooling water pressure, (install increase in
pressure, e.g. house waterworks)
Press the reset button of the motor circuit breaker
(Fig. 1 Reset button of overheating protection)
again
Turn vacuum pump (see Technical Manual)
container
Check filling level, possibly top up of the feed
water
Check kink-free laying of the intake hose
Check the position of the suction nozzle on the
floor of the water storage container
Clean suction filter
Feed water-supply from
MELAdem
Check water treatment unit, possibly open inflow
to the unit. When the pressure reservoir is empty
about 1 h after restart and the message is
repeated, have the water treatment unit checked
by the MELAG customer service
Notice! At the first start-up or re-startup, this
message can occur once since the piping system
is still not completely filled with feed water: restart
47
50
Page 51
Chapter 9 – Errors
Warning message
Possible causes
What you can do
Feed water quality bad/
Conductivity of the feed water too
Still possible to start by repeatedly pressing
Mixed-bed resin pellets consumed
MELAdem 40:
Mixed-bed resin pellets in the after
MELAdem 47:
Mixed-bed resin pellets in reverse
Other water treatment unit:
Feed water quality
Conductivity of the feed water too
Start no longer possible:
Please wait
Message is displayed during
The steam sterilizer starts automatically after
Warning/ Exchange
min./max. pressure on ventilation
exchange cartridge/
module
high
Conductivity ≥ 40 µS
ion exchanger
(3rd cartridge) consumed
the KEY (S):
Feed water-supply off
External storage container:
Empty container, clean, rinse with fresh feed
water and fill with water of corresponding quality
according to DIN EN 13060
Switch the mixed-bed resin pellets (Art. No.
61026) ,see Operating Manual for the water
treatment unit MELAdem 40
Switch mixed-bed resin pellets (Art. No. 37470),
see Operating Manual for the water treatment unit
MELAdem 47 and examine the unit
On repeated occurrence, have maintenance
carried out by MELAG customer service or
service of the specialist trade. Possibly the preand activated carbon filter must be exchanged in
addition.
osmosis facility consumed
insufficient/ No start
possible
Preheating Chamber
sterile filter
high
Conductivity ≥ 65 µS
program start phase. The steam
sterilizer has not reached the
starting temperature yet.
drying is too low/ high
Sterile filter polluted or torn
Exchange module/ resin cartridge according to
the operating manual of the manufacturer
On repeated occurrence, carry out maintenance
NOTICE: Initiate program start after completion
of the above-mentioned work. On the first start
after changing the water in the external storage
container or after maintenance on the water
treatment, this warning text can appear once
again since the inlet hose/ measuring cell are still
not completely flushed with fresh water.
See warning text: Feed water quality bad/ switch
cartridge/ module.
reaching the starting temperature.
Exchange sterile filter (MELAG Art. No. 20160)
NOTICE: Message comes at the end of the
program and in last row on logging printouts
51
Page 52
Chapter 9 – Errors
Warning message
Possible causes
What you can do
Output medium is not
The steam sterilizer is operated
Select the option in the menu Batch output No
Output medium is not correctly
Correct connection of the data cable to the steam
Electric power supply of the printer
Ensure electric power supply, the red LED "P" at
Printer is "offline"
Set printer to "online" (press key "SEL" at the
MELAprint 42, LED "SEL" must light green)
Protocol memory full
The device-internal log memory is
The message is shown at the start of a program.
An output medium is registered
Set printer to Immediate output Yes (see
Please carry out
The maintenance message is
The message is shown at program start.
Test not successful
The leakage rate determined by
1.3 mbar.
Door seal, chamber flange is
Check door seal and chamber flange for
see page 38, Chapter 6 – Maintenance
Door seal wrongly inserted
Check door seal for correct seating
Repeat vacuum test with completely cold device
Warning! Battery empty
The monitoring of the device's
The battery must be exchanged by MELAG
ready
without output medium although a
output medium is registered
connected
is interrupted
allocated (max. 40 logs possible).
and in the menu Batch output
the option Immediate output
No is set.
output medium (see page 32, Initialisation of
the log printer).
sterilizer and test at the output medium.
the log printer MELAprint 42 must light red
Repeatedly press the KEY (S) to delete the
message, and the program starts. The oldest low
is then deleted.
page 34, Automatic immediate output logfiles
Delete protocol memory (see page Fehler!
Textmarke nicht definiert., Delete stored
logfiles), possibly output all saved logs
beforehand (see page Fehler! Textmarke nicht
definiert., Print all stored logfiles
Log off the output medium in the menu batch
output output medium and set the option
no output medium..
maintenance
Leakage rate: 3.2
activated, the device has reached
the prescribed batches or number
of years has expired
the vacuum test lies above the
maximum permissible value of
contaminated
internal battery voltage has
determined a too low voltage
value.
Repeatedly press the KEY (S) to delete the
message, and the program starts.
Carry out maintenance with MELAG customer
service or service of the specialist trade
NOTICE: Service counter is reset by the
customer service
cleanliness, possibly clean
Check door seal for damage, possibly exchange,
customer service or service of the specialist trade
52
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Chapter 9 – Errors
Error message
Possible causes
What you can do
Error 1: Vacuum system
Door seal, sealing surface at the
Check door seal and sealing surface at the
Door seal wrongly inserted
Check door seal for correct seating
Error 2: Steam generator
steam sterilizer is overloaded
Pay attention to the correct loading quantities
Error 4: Pressure release
Waste water hose is bent or
Check correct laying of the drain hose from
Error 6: Ventilation
The sterile filter is polluted,
Exchange sterile filter
Error 8: Time-base
Maximum difference between
On repeated occurrence, notify specialist
Error 9: Door open
The sliding closure grip was
Push the sliding closure grip downwards until
Error 10: Overheat Steam
Capillary tube regulator "level
start (error message immediately
After program termination and immediate
Error 12: Door locking
Locking pin of the door is stiff
Check the smooth running of the locking pin
Error 13: No cooling water
See warning text Warning no cooling
Error 14: No feed water
see warning text Warning no feed water,
Error 18: Sensor: ...Input: …
The device-internal inspection of
On repeated occurrence notify your specialist
chamber is polluted or defective
Decreased heating power, since
supply voltage too low
installed with a large droop
beforehand appropriate warning
text appears
the program expiring date and
the internal computer clock is
exceeded
chamber for contamination and possibly clean
Check door seal for defects, possibly switch,
see page 12
(see page 21Load the steam sterilizer , Load
the steam sterilizer)
Check building-side electrical Installation,
operate device on a trial basis on another
electric circuit.
If problem persists, notify specialist dealers
the cooling water (with continuous gradient
and kink-free)
dealers
generator
pushed upwards during a
running program
control" is opened at program
after start) or during a program
run (until the end of the
sterilization) the monitoring time
the capillary tube regulator is
switched back (with water feed
from feed water) is exceeded
the sensors for temperature,
pressure or conductivity resulted
in a too large deviation, the
message can occur when the
device is switched on or during a
program
the stop. Correct display: Door closed
On repeated occurrence notify your specialist
dealer
start, this error message can be repeated
after a pause time of two minutes
On repeated occurrence notify your specialist
dealer
On repeated occurrence notify your specialist
dealer
water
however this error appears after the start of a
program
dealer
53
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Chapter 9 – Errors
Error message
Possible causes
What you can do
Error 21: Preheating
The monitoring time from
until
On repeated occurrence select option
Error 22: Overheat
The maximum preheating
On repeated occurrence set option
Error 26: A/D converting
The maximum admissible
On repeated occurrence notify your specialist
Error 27: Temp.Sens. def
The maximum admissible
On repeated occurrence notify your specialist
Error 31: System leak
During the program vacuum test
the permitted pressure maximum
Repeat vacuum test,
Error 32: Power loss /
The loss of the operating voltage
The error message occurs after the operating
In the event of power failure after a program
Disconnection of the steam
Only cancel a running program with KEY (S)
Error 33: Pressure drop
The maximum switch-on time of
On repeated occurrence notify your specialist
Error 34: Sterilization TU1
Shortfall of the minimum
Operate device with smaller load
Preheating
1.2
Sterilize sterile filter
switching on the pre-heating
the achievement of the
respective pre-heating
temperature was exceeded
temperature was exceeded
deviation of the computerinternal signal conditioning (A/D
converting) was exceeded
deviation between the two
temperature sensors for the
steam temperature was
exceeded
was exceeded (very large leak)
after achieving the evacuation
pressure
occurred after the start of a
program
Automatic pre-heating No ( see page
24) and notify specialist dealers
Automatic pre-heating No ( see page
24) and notify specialist dealers
dealer
dealer
if renewed error message, notify specialist
dealers
voltage is again available
Check building-side installation, If no defects
are detectable, notify customer service
sterilizer during a running
program
the steam generator for
achieving the control pressure
was exceeded
permissible sterilization
temperature
(temperature sensor 1)
has been started in overpressure, an
additionally request appears to sterilize the
sterile filter, since this has become damp and
is possibly contaminated with microbes.
Exchange sterile filter at the back side of the
steam sterilizer,
sterilize the filter in the Quick Program,
after the expiration of the program, plug in the
filter again
(see also Page 26, Manually terminate
program)
dealer
Carry out vacuum test
Check door seal for wear
On repeated occurrence notify your specialist
dealer
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Chapter 9 – Errors
Error message
Possible causes
What you can do
Error 35: Sterilization TO1
Exceeding the maximum
Carry out vacuum test
Error 36: Sterilization PU
Shortfall of the minimum
Carry out vacuum test
Error 37: Sterilization PO
Exceeding the maximum
On repeated occurrence notify your specialist
Error 38: Sterilization TD1
Maximum permitted difference
between theoretical temperature,
On repeated occurrence notify your specialist
Error 51: Sterilization TU2
Shortfall of minimum permissible
Operate device with smaller load, possibly
Error 52: Sterilization TO2
Exceeding the maximum
Carry out vacuum test
Error 53: Sterilization TD2
Maximum permitted difference
between theoretical temperature,
On repeated occurrence notify your specialist
permissible sterilization
temperature
(temperature sensor 1)
sterilization pressure
permissible sterilization pressure
quoted from the pressure signal,
and the temperature measured
at the temperature senor 1 was
exceeded
sterilization temperature
(temperature sensor 2)
Check door seal for wear
On repeated occurrence notify your specialist
dealer
Operate device with smaller load
On repeated occurrence notify your specialist
dealer
dealer
dealer
carry out Vacuum test.
Check door seal for wear.
On repeated occurrence notify your specialist
dealer.
Also see Error 34
permissible sterilization
temperature
(temperature sensor 2)
quoted from the pressure signal,
and the temperature measured
at the temperature senor 2 was
exceeded
On repeated occurrence notify your specialist
dealer.
Also see Error 35
dealer.
Also see Error 38
55
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Chapter 9 – Errors
No display on the screen
After switching on the steam sterilizer the display remains empty.
What you can do
Check whether the power plug is correctly in the socket.
Too
The feed water consumption is dependent upon the program and the
loadin
What you can do
Check the correct set-up of the steam sterilizer.
Bad drying results
Apart from a proper device function, the drying process depends
decisively on the correct setting up and loading of the
What you can do
Check the correct set-up of the steam sterilizer. If necessary
Check the supply voltage at the socket.
If necessary, switch the instrument securing at the lower front of the
steam sterilizer (see page11, Fig. 1/(8))off. Follow the instructions in
the technical manual in Exchange device fuses.
large feed water consumption
g of the steam sterilizer.
The floor of the vessel must be free. Where applicable, remove
fallen instruments, filter paper, etc.
steam sterilizer.
increase the tilt by further screwing out the front feet of the unit of
maximum 2 rotations.
The floor of the vessel must be free. Where applicable, remove
fallen instruments, filter paper, etc.
The tank filter is clogged. If necessary, check and clean it.
Pay attention to the correct loading of the steam sterilizer (see page
21 Load the steam sterilizer)
Do not overload the steam sterilizer. Pay attention that textiles have
no direct contact with the chamber wall and floor.
Activate the pre-heating (see page 24,Select automatic pre-
heating)
Employ the function Additional Drying (see page 25, Additional
Drying)
56
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Glossary
Glossary
Air leakage – checking the air leakage
Air leakage is a poorly sealed location through which
unwanted air can enter or escape;
Checking the air leakage serves to verify that the volume
of the air leak in the sterilization chamber during the
vacuum stages does not exceed a value where it would
prevents the intrusion of steam into the sterilizer load, and
that the air leakage is not a possible cause of a renewed
contamination of the sterilizer load during drying
aqua dem
→demineralized water
aqua dest
→distilled water
Authorized persons
Medical specialist dealers, technician from depots or with
customer service designated by MELAG, who were trained
by MELAG
Batch
Collection of the items to be sterilized that together passed
through one and the same sterilization program
BGV A1
Trade association regulations – Principles of Prevention
Bowie & Dick test
Steam penetration test with standard testing packet;
described in DIN EN 285; test is recognised for large-scale
sterilizations
CF card
Compact Flash Card;
Memory card for digital data of compact model size;
CF is a normed standard, i.e. this memory card can be
employed in every device with a CF slot. The CF card can
be read and possibly written by every device that supports
the standard,
Condensate
A liquid (e.g. water), which forms upon cooling from the
vaporous state and thereby separates
Conductivity
is the reciprocal value of the electrical resistance; unit of
measurement in microsiemens/centimetre (
more materials are dissolved in water, the better it
conducts electrical current and the higher is its
conductivity.
distilled water ideally has the conductivity zero
µS/cm); the
Conductivity measurement
Measurement of the conductivity
Contamination
here: Soiling of the sterilized load with unwanted or
harmful materials
Corrosion
Chemical change or destruction of metallic materials by
water and chemicals
Delayed boiling
This is the phenomenon that in certain conditions liquids
can be heated beyond their boiling point without boiling;
this state is unstable; a slight shock can cause a very rapid
formation of a large gas bubble which expands like an
explosion
Demineralized water
Also designated as aqua dem; water to a large extent
without the minerals which occur in normal mineral or tap
water; is obtained by ion exchange from normal tap water.
It is employed here as →feed water
DIN EN 867-5
European standard: non-biological systems for use in
sterilizers – Part 5: Stipulations of indicator systems and
testing bodies for performance tests of small sterilizers of
Type B and Type S
DIN EN 868
European standard: Packaging materials and systems for
medical devices to be sterilized
DIN EN ISO 11140-1
European standard – Sterilization of products for health
care – chemical indicators – Part 1: General requirements
DIN EN ISO 11607-1
Standard – Requirements on materials, sterile barrier
systems and packaging systems; this standard is a
harmonization of the DIN EN 868 Part 1 and the
international standard DIN EN ISO 11607.
DIN EN 13060
European standard –Small steam sterilizers
DIN EN 285
European standard – sterilization – steam sterilizers –
large sterilizers
Display
Display device on electronic devices; here: Graphic display
of the control panel
Distilled water
From lat. aqua destillata; also designated as aqua dest;
water, which is largely freely of salts, organic materials and
microorganisms, is obtained by distillation (evaporation
and subsequent condensation) from normal tap water or
pre-cleaned water. It is employed here as →feed water
Dynamic pressure test of the sterilization
chamber
Serves to verify that the rate of the change of pressure
occurring in the sterilization chamber during a sterilization
cycle does not exceed a certain value, which could lead to
damage of the wrapping material
[
→DIN EN 13060]
Empty chamber test
Test without load; carried out in order to evaluate the
performance of the sterilizer without the influence of the
load; permits checking the maintained temperatures and
pressures with respect to the intended settings
[→DIN EN 13060]
Evacuation
Creation of a vacuum in a vessel
Feed water
is required for the creation of water steam for the
57
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Glossary
sterilization; typical values for the water quality according
to DIN EN 285 or DIN EN 13060
FTP
(engl.: File Transfer Protocol) is a data communication
method which serves for the transmission of data from the
internet. These data can contain programs, files or
information. Special FTP programs (FTP clients) serve for
uploading any data on a server.
Fractionated pre-vacuum method
Technical methods of steam sterilization;
the repeated evacuation of the sterilization chamber
alternating with steam intake
Heating-up period
After switching on the steam sterilizer or after starting a
sterilization program, it is the time required for heating up
the steam generator before the sterilization process starts;
duration depends on the temperature of the sterilizing
process
Hollow body A
→Instruments with narrow lumen
Hollow body B
→Simple hollow instruments
Initialization
Creation of a certain initial state of the software at start-up
Items to be sterilized
Unsterile objects, materials still to be sterilized
LED
Abbreviation for Light Emitting Diode; Semiconductor
diode which lights up when powered by current. LEDs are
predominantly employed for status displays in devices, for
example to display hard disk access.
Lubricants
Instrument oil or instrument milk
Mixed load
Wrapped and unwrapped materials to be sterilized within
one load
Multiple wrapping
e.g.
instruments doubly sealed in foil or wrapped in foil are
additionally found in one container or in a textile wrapped
container
Instruments with narrow lumen
One-sided open bodies, for which applies:
1 = L/D = 750 and L = 1500 mm or
a double-sided open body for which applies:
2 = L/D = 1500 and L = 3000 mm and which does not
correspond to the hollow body B
L…hollow body length
D…hollow body diameter
Porous
Pervious to liquids and air, e.g. textiles
Porous full load – Check of porous full load
Serves to verify that for the values set on the control, the
required sterilization conditions are achieved in porous
loads with the maximum mass for their sterilization in a
sterilizer designed according to DIN EN 13060
[DIN EN 13060]
Porous partial load – Check of porous
partial load
Serves to verify that for the values set on the control, the
steam quickly and uniformly penetrates into the defined
test packet
[→DIN EN 13060]
Porous small parts
Made of materials which can absorb fluids (e.g. liquids)
Process evaluation system
Also self-monitoring system – observes itself, acts during
the programs, compares sensors with each other
RKI
Robert Koch Institute
Self-Monitoring-system
→Process evaluation system
Separate steam production
The steam generator is located outside the sterilization
chamber. The sterilization chamber is protected from
overheating in this way.
Simple hollow instruments
One-sided open bodies, for which applies:
1 = L/D = 5 and L = 5 mm or
a double-sided open body for which applies:
2 = L/D = 10 and D = 5
L…hollow body length
D…hollow body diameter
[→DIN EN 13060]
Simple wrapping
Wrapped once, e.g. instruments sealed in a foil. –
contrasted to: Multiple wrapping
Software
non-material components of a EDP system; e.g. computer
programs
Soft sterilization package
e.g. paper bags or clear-plastic sterilization packages
Solid
Without hollows or spaces; firm, dense, closed
Solid load – check of solid load
Serves to verify that for the values set on the control, the
required sterilization conditions were achieved within the
entire load. The load must represent the maximum
measurements of solid instruments for whose sterilization
a sterilizer has been designed according to DIN EN 13060
Stainless steel cleaning agent
e.g. Sidol
Standards-compliant
Conformity with all the relevant standards
Sterile barrier systems
Closed minimum packaging which prevent the occurrence
of microorganisms, e.g. bags closed with sealing, closed
reusable containers, folded sterilization cloths
Sterilized items
also designated as batch, if already successfully sterilized:
sterile goods
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Sterilization chamber
Interior of a sterilizer
Takes up the items to be sterilized
TCP
(engl. transmission control protocol) designates a
standard-protocol for a connection between computers
and networks
Vacuum
colloquially: Space free of matter
in the technical sense: Volume with reduced gas pressure
(usually air pressure)
Vacuum drying
Gentle drying; the drying goods are exposed to an
underpressure which reduces the boiling point and thereby
also at low temperatures leads to a vaporizing of the water
VDE
Verband der Elektrotechnik, Elektronik und
Informationstechnik e.V. (Association of German
Electricians)
Glossary
Water ring pump
Pump which creates the vacuum for the sterilization,
cooled with water
59
Page 60
Technical Data
Device type
Vacuklav 24 B+
Vacuklav 30 B+
Device dimensions (HxWxD)
49 x 42,5 x 72 cm
49 x 42,5 x 65 cm
Sterilization chamber (diam x
Ø 25 cm | 45 cm
Ø 25 cm | 35 cm
Volume of the sterilization
22.6 litres
17 litres
Weight (empty)
48 kg
45 kg
Electrical power
2100 W
Electrical connection
220-240V circuit (max. voltage range
220-240V circuit (max. voltage range
Noise emission
Sound pressure level @1 m space < 63 dB(A)
Waste heat (with max. solid load)
0,6 kWh / 2,0 MJ
Max. altitude
2000 m
Ambient temperature
5-40 °C (recommended max. 25 °C)
Relative humidity
max. 80% at 31 °C, decreasing in a linear fashion up to a relative humidity of
Length of power cable
1.35 m
Feed water quality
Distilled or demineralized feed water in accordance with
Cooling water quality
Drinking water
Required flow pressure
>1,2 bar at 3 l/min.
CE-mark
CE 0197, CE 0035
Degree of protection (following
IP 20
Technical Data
depth)
chamber
207-253V), 50/60Hz, building-side
recommended: separate circuit with
16 A fuse, an additional FI switch 30
mA
max. 50% at 40 °C
DIN EN 13060.
207-253V), 50/60Hz, building-side
recommended: separate circuit with
16 A fuse, an additional FI switch 30
mA
IEC 60529)
60
Page 61
Appendix A – Accessories
Article
Order number*
Vacuklav 24 B+
Vacuklav 30 B+
Tray mounts
A for 5 trays or 3 standard-tray cassette
40244
40233
B for 4 standard-tray cassettes
40224
40234
D for 2 high cassettes or 4 trays
46840
EN 868-8
15K depth/ width/ height in cm: 18/ 12/ 4,5
01151
15M depth/ width/ height in cm. 35/ 12/ 4,5
01152
15G depth/ width/ height in cm: 35/ 12/ 8
01153
17K depth/ width/ height in cm: 20/ 14/ 5
01171
17M Depth/ width/ height in cm: 41/ 14/ 5
01172
17G depth/ width/ height in cm: 14/ 14/ 9
01173
23M depth/ width/ height in cm: 42/ 16/ 6
01231
23G depth/ width/ height in cm: 42/ 16/ 12
01232
28M depth/ width/ height in mm: 32/ 16/ 6
01284
28G depth/ width/ height in mm: 32/ 16/ 12
01285
17R diameter/ height in cm: 13/ 10,5
00174
23R diameter/height in mm: 18/ 14
00233
Package Holder
for chamber ∅ 25 cm X 45 or 35 cm
22420
22410
Standard tray cassette
Perforated, depth/width/height in mm: 29/ 19/ 4
with filter cloth
without filter cloth
Trays
tray
00230
00280
MELAcontrol consisting of helix test body and
250 indicator strips
MELAcontrol /PRO consisting of helix test
body and 40 indicator strips