Page 1
Dear doctor,
We thank you for your confidence demonstrated by the purchase of this autoclave.
Since 1951, MELAG began as a medium-sized family-run enterprise to specialise in the manufacture of
sterilization equipment for medical practices. In the meantime our company has grown into one of the
world's leading producers of sterilization equipment. Verification of it success has been the sale of
more than 450,000 MELAG units worldwide, attesting to the high quality of our sterilizers, which are
exclusively made in Germany.
This autoclave has also been manufactured and tested according to the most stringent quality criteria.
Nevertheless, please read the User Manual carefully before the initial start-up of the device. The longterm serviceability and the retention of value of your autoclave depend primarily on the careful
preparation of the instruments and the regular maintenance of the device.
MELAG - General Management and employees
User Manual
Autoclave
Euroklav®23 VS+
Euroklav
®
29 VS+
as of software version 4.06
Page 2
User Manual of Euroklav®23 VS+, Euroklav®29 VS+
Valid for Euroklav®23 VS+, Euroklav®29 VS+
as of software version 4.06
1st Edition October 2007
Responsible for the contents: Engineering Department
MELAG Medizintechnik oHG
Geneststraße 6-10
10829 Berlin
Germany
E-mail: info@melag.de
www.melag.de
© 2013
Document: BA_2_GB_23VS+_29VS+_v7.docx/ Revision: 7 – 12/0429
Subject to technical changes
For physicians, physician's assistants, and service personnel
P
lease read this User Manual
before you start operation of the autoclave. The
instructions contain important safety precautions. Make sure to keep the User Manual
near to the autoclave. The instructions are a part of the product.
Page 3
Foreword
Thank you for deciding to buy this MELAG autoclave.
This User Manual describes both the autoclaves Euroklav®23 VS+ and
Euroklav
®
29 VS+. They are identical except for their chamber depth and
device depth.
Device name
The device name "autoclave" is used in this User Manual to designate the
steam sterilizers
Euroklav®23 VS+ and Euroklav®29 VS+.
User Manual
The User Manual contains important safety instructions and information
which you need to operate the autoclave. Read these instructions carefully
and thoroughly in proper sequence.
Avoid dangers
Please read all the safety instructions attentively before using the
autoc
lave.
About this manual
Symbol
Meaning
Explanation
Danger!
Risk to health
Indicates a dangerous situation which if not avoided
could entail slight to life-threatening injuries.
Warning!
Observe
without fail
Indicates a dangerous situation which if not avoided
could entail damage to the instruments, the practice
equipment or the autoclave.
Important
information
Indicates important information.
Example of emphasis
Meaning
Explanation
→Conductivity
measurement
Glossary entry
Words or phrases marked with an arrow are
explained in the glossary. The glossary is listed
alphabetically. It can be found at the end of this
manual.
Universal program
Software
citation
Words or phrases appearing on the →display of the
autoclave are marked as software citations.
Chapter 6 – Logging
Cross-
reference
Reference to another text section within this User
Manual.
Figure 1/(5)
Cross-
reference
Reference to a detail in a figure – in the example, to
Part No. 5 in Figure 1.
Page 4
Safety instructions
Safety instructions
To operate the autoclave, pay attention to the following safety instructions
given below and in the individual chapters of this User Manual.
Instruction
■ Do not sterilize any liquids with this autoclave.
Mains cable and power
plug
■ Never damage or change the mains cable or power plug.
■ Never operate the autoclave if the mains cable or power plug are
damaged.
■
Never pull on the mains cable to take it out of the socket. Always take
hold of the power plug itself.
Setting up, installation,
commissioning
■ Only have the autoclave set up, installed, and commissioned by
people authorised by MELAG.
■ Only operate the autoclave 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.
Preparation and
sterilization of textiles and
instruments
■ Follow the instructions of the textile and instrument manufacturers for
preparing and sterilizing textiles and instruments.
■ Observe the relevant standards and directives for the preparation
and sterilization of textiles and instruments, e.g. →RKI [Robert Koch
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.
Program termination
■ Take heed that when opening the door after terminating a running
program, hot water steam can escape out of the chamber, depending
on when the program was terminated.
■ D
epending on the time of the program termination, the load might not
be sterile. Observe the clear instructions shown on the →display of
the autoclave. If necessary, sterilize the affected →objects after
rewrapping.
Removal of the items to be
sterilized
■ Never open the door by force.
■ Use a tray lifter to remove the tray. Never touch the →sterilized
items, the chamber or the door with unprotected hands. The parts are
hot.
■ Check the wrapping of the sterilized objects for damage when
removing them from the autoclave. If a wrapping is damaged, wrap
the object again and re-sterilize it.
Maintenance
■ Have the maintenance done only by →authorized persons.
Carrying the autoclave
■ Two people are necessary to carry the autoclave.
■ Use a suitable carrying strap to transport the autoclave.
Errors
■ If repeated error messages occur while operating the autoclave, turn
the device off and notify your specialist dealer.
■ Only have the autoclave repaired by →authorized persons.
Page 5
Contents
Chapter 1 – Performance Specification .............. 6
Proper use .............................................................. 6
User benefit ............................................................ 6
Overview of sterilization programs .......................... 8
Chapter 2 – Device Description ........................... 9
Scope of delivery .................................................... 9
Device views......................................................... 10
Effective capacity .................................................. 11
Mountings for the load .......................................... 11
Control panel ........................................................ 12
Supply with feed water ......................................... 12
Chapter 3 – Initial start-up ................................. 14
Conditions for setting up, installing and starting up
............................................................................. 14
Set-up location requirements ................................ 14
Connections required ........................................... 15
Prerequisites for initial start-up ............................. 17
Record of installation and setting up ..................... 17
Switch on autoclave .............................................. 17
Chapter 4 – Sterilization ..................................... 18
Create prerequisites ............................................. 18
Select feed water supply ...................................... 18
Prepare items to be sterilized ............................... 19
Load the autoclave ............................................... 20
Close the door ...................................................... 22
Select program ..................................................... 22
Select automatic pre-heating ................................ 23
Select additional drying ........................................ 24
Start program........................................................ 24
Program is running ............................................... 24
Manually terminate program ................................. 25
Sterilization phase is finished ............................... 26
Drying phase ........................................................ 26
Program is finished ............................................... 27
Display batch number ........................................... 27
Remove sterilized items ....................................... 27
Storage of sterilized items .................................... 28
Chapter 5 – Logging ........................................... 29
Batch documentation ............................................ 29
Set date and time ................................................. 29
Use printer as output medium............................... 30
Employing MELAflash as output medium ............. 31
MELAnet Box as output medium .......................... 32
Computer as output medium ................................ 32
Automatic immediate log output ........................... 32
Output the logs subsequently ............................... 33
Display protocol memory ...................................... 34
Read log files correctly ......................................... 34
Chapter 6 – Maintenance ................................... 36
Cleaning ............................................................... 36
Avoid formation of spots ....................................... 37
Use qualitatively high-grade feed water ................ 38
Exchange the door seal ........................................ 38
Maintenance ......................................................... 38
Chapter 7 – Operating pauses ........................... 40
Sterilization frequency .......................................... 40
Pause times .......................................................... 40
Shut-down ............................................................ 41
Transport .............................................................. 41
Re-startup after change of locality ........................ 41
Chapter 8 – Function test................................... 42
Automatic function test ......................................... 42
Manual function test ............................................. 42
Testing in daily operation ...................................... 43
Vacuum test.......................................................... 43
Bowie & Dick test .................................................. 43
Display water quality ............................................. 44
Chapter 9 – Errors .............................................. 45
A warning is not an error ...................................... 45
Warning messages ............................................... 45
Error message ...................................................... 45
Before you call ...................................................... 46
No display on the screen ...................................... 52
Too large feed water consumption ....................... 52
Bad drying results ................................................. 52
Glossary .............................................................. 54
Appendix A – Accessories................................. 57
Appendix B – Symbols on the autoclave ......... 58
Page 6
6
Chapter 1 – Performance Specification
In this chapter you learn
Under which conditions and for which purpose you should use this autoclave
What benefit you can achieve by using this autoclave
Which sterilization programs you can use
Proper use
Application area
The autoclave is intended for use in every kind of general medical area
where no Class B autoclave is required due to the instruments used and
type of packaging.
Sterilization tasks
According to →DIN EN 13060 this autoclave is considered a Class S
sterilizer. As a universal autoclave, it is suited for sterilizing
unwrapped/
wrapped massive instruments,
simple hollow body instruments
(Hollow Body B) and smaller quantities of textiles.
Danger of burning!
Observe the following instructions for using the autoclave:
■ Do not sterilize any liquids with this autoclave. It is not approved for
the sterilization of liquids.
In case of non-observance, the consequences could be →delayed
boiling, damage to the autoclave and burns.
Warning!
■ Use the autoclave only for the intended purposes outlined in the
related technical documents and only in connection with the devices
and components approved by MELAG.
■ The sterilization of instruments and textiles with this autoclave, like
the foregoing instrument sterilization, 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 autoclave and/or to the →items to be sterilized.
User benefit
Universal use
The autoclave sterilizes on the basis of the →pre-vacuum method
combined with the →fractionated
flow method.
These methods ensure the
complete and effective wetting or penetration of the items to be sterilized
with saturated steam. The procedure can also be used to safely and
quickly sterilize wrapped instruments or textiles.
Low time expenditure,
overheating protection
To generate the sterilization steam, the autoclave uses an →integrated
steam generator. The sterilizer chamber is protected from overheating and
you can sterilize instruments and small quantities of textiles in a short time.
Automatic pre-heating
The cold chamber is preheated on activation of preheating or can be
maintained at a specific temperature between two sterilizations. This
shortens the program time periods and reduces the formation of
condensate to give improved drying results.
Page 7
Chapter 1 – Performance Specification
7
Internal feed water supply
in one-
way and circulatory
flow system
The autoclave works both according to the feed water one-way system as
well as the feed water circulatory flow system.
In the one
-way system, it uses fresh purified feed water for every
steriliz
ation run. The quality of the feed water is constantly monitored via
integrated conductivity measurement. This prevents stains on instruments
and soiling of the autoclave, provided the instruments have been carefully
prepared. In the feed water circulatory flow system, the autoclave works in
a more water-conserving manner, since the feed water is used for several
sterilization runs. The quality of the feed water is constantly monitored via
integrated conductivity measurement here as well.
Automatic feed water
supply
The →feed water for generating the steam is automatically supplied via
an internal water storage tank or a water treatment unit (e.g. MELA
dem®
40, MELA
dem® 47).
Optimal drying for
wrapped items to be
sterilized
The sterilized items are dried with the →pulsating overpressure and
vacuum drying method. This way you achieve optimal drying results for
wrapped objects as well.
Optimized total operating
time
The autoclave works with an →electronic parameter control. This way the
autoclave
optimizes the total operating time of a program depending on
the load.
High safety with
extensive
safety devices
The autoclave 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
autoclave. It monitors the process parameters such as tempera
ture, time
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 below the determined limit
val
ues, the autoclave outputs a warning or fault messages and, if
necessary
, aborts the program. In the event of an automatic program
abort, observe the information on the display.
Additional
function check
With the help of the test programs, you can conduct an additional
function check at any time.
With the
→Bowie & Dick-test, you can verify the autoclave for sufficient
steam penetration of porous sterilizing materials (e.g. textiles).
With
→Conductivity measurement, you can verify the water quality of the
feed water.
Effective batch
documentation
The autoclave 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.
Page 8
Chapter 1 – Performance Specification
8
Overview of sterilization programs
Type tests
Universal-
Program
Quick-
Program S
Gentle-
Program
Prion-
Program
Program type as per
→DIN EN 13060
Type S
Type S
Type S
Type S
→Dynamic pressure test of the sterilization
chamber
X X X
X
→Air leak X X X X
→Empty chamber test
X X X
X
→Solid load
X X X
X
→Porous partial load
X X
X
→Porous full load
→Hollow body B
X X X
X
→Hollow body A
→Simple wrapping
X X X
X
→Multiple wrapping
X X X
X
Drying →solid load
X X X
X
Drying →porous load
X X
X
Sterilization temperature
134°C
134°C
121°C
134°C
Sterilization pressure
2 bar
2 bar
1 bar
2 bar
Sterilization time
5.5 min.
3.5 min.
20.5 min.
20.5 min.
X = Conformity with all applicable sections of the standard →DIN EN 13060
Page 9
9
Chapter 2 – Device Description
In this chapter you learn
Which components are included in the standard scope of delivery
Which components the autoclave contains
What safety devices the autoclave 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 autoclave needs
Scope of delivery
Standard scope of delivery
Euroklav®23 VS+ or Euroklav®29 VS+
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 hose for draining the internal storage tank
1 TORX wrench for removing the carrying strap
1 lever for emergency unlocking of the door
1 tank filter key
2 replacement device safeguards on the inside door of the
autoclaves
As option
Trays
Tray lifter
Standard tray cassette and lifter
Additional tray mounts
Log printer MELAprint®42
MELAflash CF card writer with CF card and card reader
MELAnet Box
Page 10
Chapter 2 – Device Description
10
Device views
Front side
(1)
(2)
(3)
(4)
(5)
Operating and display field
Door (pivots opens to the left)
sliding closure
grip
Mains switch
Front foot of the unit (adjustable)
Front side below with opened door
(6)
Serial data and printer connection (RS232)*
(7)
(8
)
Device fuses – 2x 16A/ gRl
Reset button for overheating protection
(9)
Connection for emptying the storage tank feed water
(10)
Connection for emptying the storage tank waste water
*hidden behind the white cover
Back side
(11)
Tank cap
(1
2)
(13)
(14)
(15)
(16)
(17)
Safety
valve
Sterile filter
One
-way drain
Purified feed water inlet via internal storage tank
Hose bridge for internal feed water supply
Power cable
Fig. 1: Device views
Page 11
Chapter 2 – Device Description
11
Interior view
(1)
(2)
(3)
(4)
(5)
(6)
Chamber
Mounting to hold trays/ cassettes
Door locking pin
Chamber sealing surface
Blue door s
eal
Door plate
Fig. 2: Interior view
Effective capacity
Device type
Diameter
Depth
Volume
Euroklav®23 VS+
∅25 cm
45 cm
22 litres
Euroklav®29 VS+
∅ 25 cm
35 cm
18 litres
Mountings for the load
The autoclave 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
cassettes rotated by 90°.
Fig. 3: Mounting A
The mounting (B) can hold four standard tray cassettes or four
trays.
Fig. 4: Mounting B
The mounting (D) can hold two high cassettes (e.g. for implant
cassettes) or four trays rotated by 90°.
Fig. 5: Mounting D
Page 12
Chapter 2 – Device Description
12
Control panel
The control panel consists of a two-line alphanumerical LED display and four
membrane keys.
Initial state
The display switches to the initial state after every switch-on, where the
current time and the chamber pressure in bar
and the (steam)
temperature in °C is displayed.
Supply with feed water
The autoclave requires →demineralized or →distilled →feed water for
steam production according to
→VDE 0510. The feed water supply is
provided
either by an external water storage tank or with a water
treatment unit (e.g. MELA
dem®40/ MELAdem® 47). The autoclave
automatically sucks in the feed water.
Feed water with internal
storage tank
If you employ the internal storage tank for the feed water supply, you
must fill it manually from time to time. At the given point in time, the
autoclave outputs an appropriate message. Only use water according to
→VDE 0510 as →feed water.
Internal storage tank
The internal storage tank holds maximum 5 litres. This quantity of →feed
water suffices for up to 7 sterilizations.
Distilling unit MELAdest®65
With the MELAdest®65 distilling unit, you can produce →feed water in
the practice cost
-effectively.
Feed water via water
treatment system
A water treatment unit is connected to the domestic water supply. It
produces the →feed water required for generatin
g the steam for the
autoclave.
The purified feed water connection for the autoclave is directly
connected to the water treatment uni
t.
If you use a water treatment unit, then there is always su
fficient feed
water available.
You no longer have to manually fill the water storage
tank.
The waste water can either be collected in an internal storage tank and
manually emptied or automatical
ly drained via the one-way drain.
Function key (-) and (+)
to select, set and display special functions:
print
, date/time, preheating, total batches,
conductivity, acknowledge error
, KEY (+)
for unlocking the door
Program selection button (P)
to select the sterilization programs/ test
programs and select or set options
(submenus)
of the special functions
Start – Stop button (S)
to start programs, terminate
programs / drying as well as
control of the special
functions
Time (h:min:s)
chamber pressure (bar) and
(steam)-
temperature (°C)
2-line LED display
for program status display and
parameter display
Page 13
Chapter 2 – Device Description
13
Water treatment units
MELAdem®40 and
MELAdem®47
The water treatment units MELAdem®40 and MELAdem®47 produce the
optimal purified feed water quality for the autoclave. The selection of the
respective unit depends on
the number of sterilizations per day and the
respective loads. Both MELAG autoclaves can be supplemented with a
water treatment unit.
NOTICE:
Please first consult with MELAG if you would like to employ water
treatment units of other manufacturers.
Page 14
14
Chapter 3 – Initial start-up
In this chapter you learn
Who may set up, install and start up the autoclave
Which prerequisites you must create for setting up, installing and starting up the
autoclave
Conditions for setting up, installing and
starting up
■ Only have the autoclave set up, installed, and started up by people
→authorized by MELAG.
Danger!
■ According to the currently valid VDE standards, this device is not
suitable for use in areas subject to explosion hazards.
■ The autoclave 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 autoclave and/or injuries can occur in case this
precaution is not observed.
Set
-up location requirements
Location
Set up the autoclave in a dry and dustproof location. The air humidity
should be 30% to 60% and the ambient temperature 16° to 26 °C.
Warning!
■ Without fail, keep the specified distance free to the surrounding
surfaces at the sides and above the autoclave.
Non-observance can lead to heat accumulation. This could
adversely affect the function of the autoclave and entail the
shortening of the vacuu
m pump's service life and result in extended
program times.
Distance to the surrounding
surfaces
The distance to the surrounding surfaces must be at least 10 centimetres
on both sides and 10
centimetres at the back side. The autoclave should
be freely accessible from above, so that the built
-in storage tank can be
filled and a good ventilation is guaranteed.
Page 15
Chapter 3 – Initial start-up
15
Space requirements
Euroklav®23 VS+
Euroklav®29 VS+
Width
Height
Depth
A= 42.5 cm
B= 48.5 cm
C= 69 cm
D= 43.5 cm
E= 9 cm
F= 10 cm
G= 10 cm
A= 42.5 cm
B= 48.5 cm
C= 61 cm
D= 32 cm
E= 12 cm
F= 10 cm
G= 10 cm
maximum acoustic power for Euroklav®23 VS+ and Euroklav®29 VS+: < 52 dB (A)
Additional space for
feed water supply
Other than for the autoclave, the water treatment unit for the feed water
supply require space.
NOTICE:
In no case may you subject the water storage ta
nk to sunlight. This way
you avoid algae formation.
The maximum suction height from the external storage tank is 1.5
metres.
Space requirement for
water treatment unit
MELAdem®40
can be directly hung on to the autoclave on the side
The attachment can be next to the autoclave or above or below the
autoclave
MELA
dem®47
Attachment next to the autoclave or above or below the autoclave
(e.g. lower cabinet)
delivered with water storage tank
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
Danger of injury!
■ The electric connections and connections for feed water and used
water may only be completed by a specialist technician.
Non-observance could lead to a short-
circuit and/or fire and/or water
damage and/or electrical shock. Serious injuries could be the
consequence.
Page 16
Chapter 3 – Initial start-up
16
Electrical connection
Provide the following electrical connections for the autoclave:
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
Connected load for
Euroklav® 23 VS+
2300 W as of software version 4.10
2600 W with software version 4.07
3000 W with software version 4.06
Connected load for
Euroklav®29 VS+
2100 W as of software version 4.07
2400 W with software version 4.06
NOTICE:
In order to prevent water damage, MELAG recommends the use of a
leak monitor, e.g. water stop valve from MELAG (Art. No. 01056)
.
Waste-water drain
The autoclave is connected to the drain via the one-way drain (see page
10
, Fig. 1/ (14)).
The connection must be located below the autoclave.
The one
-way drain hose can be connected as follows:
To an existing sink drain
To a separate drain pipe when using the surface-mounted siphon
from MELAG (Art. No. 37410 – not in the standard scope of delivery)
You can reorder a 2
-m long hose (Art. No. 36585) for the one-way drain
hose.
NOTICE:
The waste
-water hose must be laid dip-free with continuous descent.
For waste
-water paths which are longer than two metres we recommend
a fixed laying of HT (high temperature) piping by a specialised installation
firm.
Observe the following precautionary measures when handling the
mains cable and power plug:
Danger of injury!
■ Never splice or modify the mains cable.
■ 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 autoclave.
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.
Insert power plug into the
socket
Plug the power plug into the socket.
Page 17
Chapter 3 – Initial start-up
17
Prerequisites for initial start-up
The following prerequisites must be satisfied for initial start-up:
The feed water supply must be secured.
The power supply of the autoclave must be assured.
Record of installation and setting up
NOTICE:
As documentation of proper setting up, installation and setting up as well
as for your warranty claim, the record of installation must be filled out by
the person responsible and a copy sent to MELAG.
Switch on autoclave
Switch on mains
Turn the mains switch on to power the autoclave (page 10, Fig. 1/(4)).
After switching on
After switching on the autoclave with the mains switch, the →display
shows in alternation to the initial state the message Unlocking
door with button (+)
, if the door is closed.
Directly after having switched on the autoclave and before initial start-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
Page 18
18
Chapter 4 – Sterilization
In this chapter you
learn
Which prerequisites should be created for a smoothly-running sterilization
How to switch between internal and external feed water supply
How to switch between the one-way and circulatory feed water system
What you should observe when preparing the items to be sterilized
How to correctly load the autoclave
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
Create prerequisites
Create the prerequisites for a smooth and successful sterilization process
as
follows:
Provide feed water
If you use an internal storage tank for the feed water supply, fill this
with feed water of the respective quality (see page 38, Use
qualitatively high-grade feed water ). You can use the removable
funnel insert to conveniently fill fresh feed water into the right
chamber of the storage tank up to the MAX mark. Simply remove the
filter for cleaning.
If you employ a water treatment system, e.g. MELAdem®40,
MELAdem
®
47, and the water feed is closed, then open it up. If the
water storage tank of the MELAdem®47 is empty, turn the water feed
tap on at least one hour before the sterilization..
Switching on
If the autoclave is still not switched on, switch it at the mains switch
(page 10, Fig. 1/(4)). (See as of page 17, Switch on autoclave).
Select feed water supply
Switch between internal and
external feed water supply
Depending on whether the feed water should be supplied from the
internal s
torage tank or whether you employ a water treatment unit for
the feed water supply, select the appropriate setting on the display.
Select the setup menu by simultaneous brief pressing of the K
EYS
(+) and (-). The display shows Function: Last batch
number..
Navigate with the KEY (+) or (-), up to the display
Function: Feed water–supply.
Press the KEY (P). The currently set option appears on the display,
e.g.
Feed water-supply – intern.
To set the value to Feed water-supply – extern, press the
KEY (P) again.
In order to save the setting and to leave the menu, press the KEY
(S).
Page 19
Chapter 4 – Sterilization
19
By again pressing the Key (S), you completely leave the menu and
return to the starting position of the display.
At initial delivery, the
Feed water-supply is set to intern.
Choose the one-way feed
water or circulatory system
You can choose the one-way feed water or circulatory system for your
feed water supply from the internal storage tank. To do so, you must
change the setting on the display before starting a program:
Select the SETUP Menu 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: Water system is displayed.
Press the KEY (P). The currently set option appears on the display,
e.g.
Water system – one-way.
To set the value to Water system – circle, press the KEY (P)
again.
In order to save the setting and to leave the menu, press the KEY
(S).
By again pressing the
KEY (S), you completely leave the menu and return
to the starting position of the display.
NOTICE:
If the autoclave is supplied with feed water via a water treatment unit, you
cannot select the menu Function: Water system
.
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, cleaning agents and processing
procedure employed are of significance.
NOTICE:
If possible, sterilize textiles and instruments separately from each other in
separate sterilization contain
ers or sterilization packages.
This way you achieve improved drying results.
Textiles
Observe the following instructions for treating textiles and putting
the textiles into sterilization containers:
Danger!
■ Comply with the instructions of the textile manufacturer for treatment
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. Unsterile
textiles
could be the consequence. This could mean endangering the health
of the patient and the practice team.
Program
Start-Stop
Page 20
Chapter 4 – Sterilization
20
Instruments
Observe the following instructions for treating used and brand new
instruments:
Danger of infection!
■ Follow without fail the instructions of the instruments manufacturer
for treatment and sterilization, and observe the relevant standards
and directives of your country.
■
Clean the instruments very thoroughly, for instance with the help of a
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
autoclaves 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.
When using the following devices, observe without fail the preparation
instructions of the instrument manufacturer:
Ultrasonic units
Maintenance appliances for hand pieces and angle pieces
Cleaning and disinfection devices (e.g. thermal disinfector)
Load the autoclave
Only if the autoclave is properly loaded can the sterilization be effective
and the drying deliver good results.
NOTICE:
Use perforated trays,
such as the trays from MELAG. Only this way can
→
condensate run off. If you use closed materials or shell halves to bear
the items to be sterilized, you risk bad drying resu
lts. Please note that the
use of tray insertions made of paper can perhaps likewis
e lead to worse
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
systems), which satisfy the DIN EN IS0 11607-1 Standard.
You can employ reusable rigid packaging such as standard tray
cassettes or soft packaging such as clear
-plastic sterilization packages,
paper bags, sterilization paper, textiles, fleece.
Closed sterilization -
containers
Preferably use sterilization containers made of aluminium. Aluminium
conducts heat we
ll and thus accelerates drying.
Page 21
Chapter 4 – Sterilization
21
When using closed sterilization containers, observe the following
instructions for holding the
→sterilizing materials:
Warning!
■ Closed sterilization containers must be equipped at least on one side
– possibly below – with perforations or valves.
Non-
observance leads to insufficient steam penetration which could
make the sterilization ineffective. Furthermore the condensate
drainage is prevented, and bad drying results are the consequence.
This can ultimately lead to unsterile instruments and thereby to
endangering the health of the patient and the practice team.
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
containers
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.
Danger!
■ When stacking the sterilization containers, take care that the
perforations are not covered.
In case of non-observance, the condensate cannot drip off to the
vessel bottom. It would soak sterilizing materials lying underneath.
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.
Soft sterilization wrapping
→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 MELAfol®, observe the
following instructions:
Warning!
■ Arrange the →soft sterilization packages standing vertically at small
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
instruments an
d sterilize them once again. The packaging should be
filled to ¾ or the spacing for the sealing seam at 3 cm.
■
If the welding seam tears open during sterilization, extend the sealing
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.
Multiple wrapping
The autoclave functions on the →fractionated pre-vacuum method. This
permits the use of
→multiple wrapping.
Mixed loads
For sterilizing mixed loads, observe the following instructions:
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
The heaviest loads at the bottom
Stack transparently wrapped 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.
Page 22
Chapter 4 – Sterilization
22
Loading variants
Euroklav®23 VS+
Euroklav®29 VS+
Instruments
Textiles
Instruments
Textiles
Greatest weight per single
piece
2 kg
1 kg
2 kg
0.8 kg
Loading variant
mounting A*
max. 5 trays, depth 420 mm
max. 6 sterilization containers 15K
max. 3 sterilization containers 15M
max. 2 sterilization containers 15G
max. 6 sterilization containers 17K
max. 3 sterilization containers 17M
max. 1 sterilization containers 17G
max. 3 swab drums 17R
max. 1 sterilization container 23G
max. 2 sterilization containers 23M
max. 2 swab drums 23R
max. 2 sterilization containers 28M
max. 1 sterilization containers 28G
max. 3 standard tray cassettes
max. 5 trays, depth 290 mm
max. 3 sterilization containers 15K
max. 3 sterilization containers 17K
max. 3 swab drums 17R
max. 2 swab drums 23R
max. 2 sterilization containers 28M
max. 1 sterilization container 28G
max. 3 standard tray cassettes
Maximum total weight
4 kg
1 kg
3 kg
0.8 kg
*Mountings, trays, sterilization containers, norm-tray cassettes from MELAG, see Appendix A – Accessories
Close the door
When closing the door of the autoclave, observe the following
instructions:
Close the door with light pressure against the chamber flange and
simultaneously press down the sliding-closure grip.
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.
Furthermore, consider the resistance to high
temperature of the items to
be sterilized.
The following table shows which program to use for which items to be
sterilized.
Page 23
Chapter 4 – Sterilization
23
Programs
Wrapping
Especially
suitable for
Sterilization
at
Operatin
g time*
Drying
Load
23 VS+/29 VS+
Universal-
Program
→single and
→
multiple
wrapping
→mixed loads;
long, simple hollow
bodies
134 °C 25 min 25 min 4/3 kg
Quick-
Program S
only
unwrapped
(no textiles)
simple →solid
instruments,
transmission
instruments; simple
hollow bodies
134 °C 15 min 10 min 4/3 kg
Gentle-
Program
→single and
→
multiple
wrapping
textiles
thermo-instable goods
(e.g. plastic, rubber
articles)
→Mixed loads
121 °C 40 min 25 min
Textiles
1 /0.8 kg
Thermo-instable
Goods
4/3 kg
Prion-
Program
→single and
→
multiple
wrapping
instruments where a
danger of infection by
pathologically-modified
proteins is suspected
(e.g. Creutzfeld-Jacob,
BSE)
134 °C 40 min 20 min 4/3 kg
* without drying (full load in the Euroklav®23 VS+ 4 kg and Euroklav®29 VS+: 3 kg) and depending on the load
and installation conditions (such as supply voltage)
Select automatic pre
-heating
With the automatic pre-heating, the chamber of the autoclave before a
program start is kept to the program
-specific pre-heating temperature or
maintained at this temperature between two program runs.
Prerequisite is that the autoclave remains continuously switched on.
The condensate formation at the chamber wall is reduced and drying is
supported. The cycle times shorten.
The automatic pre
-heating is activated in the factory settings.
In order to change this setting if desired, proceed as follows:
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
preset option, e.g.
Pre-heating Yes.
Press the KEY (P) once again, switch the display to Pre-heating
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.
NOTICE:
MELAG recommends the activation of automatic pre
-heating.
Page 24
Chapter 4 – Sterilization
24
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:
When starting the program, simultaneously press the KEY (S)
AND KEY (+).
The display shows
Supplement drying selected. Then the
program sequence begins.
Start program
If you have selected a program with the program selection button, in
addition to the selected program the sterilization temperature is displayed
and whether the respective program for packaged or unpacked sterilizing
materials is suitable.
Press the KEY (S), in order to start the program.
The autoclave checks the transport of the →feed water and its
→
conductivity.
If the Quick
-Program S is started, the warning text Warning only
unwrapped instruments
is shown on the display.
If the load exclusively contains unwrapped instruments, press the
K
EY (S) once again to confirm and start the program.
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.
Pre-vacuum
In the →Pre-vacuum the air is sucked out by evacuation and steam is
conducted into the chamber until a program
-dependent pressure up to a
slight overpressur
e is reached.
Evacuation phase
In the subsequent evacuation phase the →fractionated flow method with
pulsating, repeated steam entry and outlet sucks the air out of the
chamber and conducts saturated steam into the chamber.
Depending on selected program and the current chamber temperature at
program start, additional
→fractionations are connected.
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 reached.
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 pressure discharge with a corresponding display is carried out at the
end of the sterilization phase.
Drying phase
The drying phase begins after the pressure discharge.
This runs in two stages, the flow drying and the vacuum drying.
A program can be terminated during the →flow drying as well as during
Program
Start-Stop
Program
Start-Stop
Program
Start-Stop
Program
Start-Stop
Page 25
Chapter 4 – Sterilization
25
the →vacuum drying ( = pulsating overpressure drying) without resulting
in an error message being shown on the display.
The regular drying time is 10 minutes for the Quick-Program S, 20
minutes
for the Gentle-Program and for the Universal program and the
Prion
program 25 minutes.
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
-observance, an error message of power loss is displayed
when the autoclave is switched back
on.
Danger of burning!
■ Take heed that when opening the door after terminating a running
program, hot water steam can escape out of the chamber,
depending on when the program was terminated.
■ 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.
Manual termination before
beginning of drying
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:
Press the KEY (S).
Confirm the following prompt Stop program? Repeatedly press
"Stop"
with the KEY (S).
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
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 acknowledgement
of the program termination.
The screen alternately displays
Stop/ End and Ackknowledge with
button
’-’.
Press KEY (-).
The message
Unlocking door with button ’+’ is displayed in
alternation with the previously
-selected program.
After pressing the
KEY (+) you can open the door.
A reference to
Program stopped/ load not sterile is issued to
the logging printout.
Manual termination
during drying
In the drying phase you can cancel the program with the KEY (S).
Program
Start-Stop
Program
Start-Stop
Page 26
Chapter 4 – Sterilization
26
You must then expect insufficient drying, especially for wrapped
→
sterilized items. Sufficient drying is a prerequisite for sterile storage.
Therefore, if possible, always let sterilization programs with wrapped
items continue up to the end of the drying
phase.
In a
Quick program, sterilized unwrapped instruments dry from their own
heat after removal from the autoclave.
In the drying phase, the expired drying time is shown in alternation with
the message
Immed. Removal Press "Stop" is displayed.
To term
inate the program, carry out the following steps:
Press the KEY (S).
Confirm the following prompt Stop program? Repeatedly press
"Stop" with the KEY (S).
The termination is confirmed with
Drying stopped on the display.
NOTICE:
The confirmation prompt
is shown for about 5 seconds on the display. If
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
Universal-Program run successfully follows in
alternation with
Last batch number. xx and quit with ’+’.
If a printer or another output medium is connected to the autoclave and
the
Immed. Output is set to yes, a reference to Drying stopped is
issued to the logging printout.
Sterilization phase is finished
Sterilization phase
successfully finished
You can recognize on the display whether the sterilization phase has
successfully
completed.
The remaining time of the sterilization phase is displayed in alternation
with the
specification of the pressure and temperature.
Sterilization not successfully
finished
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 is terminated by the operator, a warning text appears. If
the program is aborted by the system, an error message is displayed.
Drying phase
The autoclave does an excellent job of drying the items to be sterilized.
In the event of difficult drying tasks it might however be necessary to take
the following measures to further improve drying:
Improve drying results
Load the autoclave correctly for drying. Place items wrapped in
sterilized clear plastic or paper upwards like filing cards.
Observe Section Load the autoclave on page 20. Possibly employ
the package holder.
Activate the function Supplement Drying. Observe the Section
Select additional dryingon page 24.
Page 27
Chapter 4 – Sterilization
27
Program is finished
The chamber pressure is adapted to the ambient pressure at the end of a
program
. If 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 immediate
output (see page 29, Chapter 5 –
Logging
).
Display
batch number
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:
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.
In order to reach the starting position again, press the
KEY (S) twice.
Display total batch number
You can allow the display of the number of total →batches.
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 (-), up to the display where the
submenu
Batch counter is shown.
Press the KEY (P).
You see t
he current counter reading of the total batch number on the
display
In order to reach the starting position again, press
the K
EY (S) twice.
Remove sterilized items
Danger of burning!
After the end of a program observe the following instructions for removing
the →sterilized items:
■ Never open the door by force. The autoclave 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.
Danger
■ Check the wrapping of the sterilized objects for damage when
removing them from the autoclave.
■ If a wrapping is damaged, wrap the object again and re-sterilize it.
Non-
observance can result in unsterile instruments. This endangers
the health of the patient and the practice team.
Open door
After the end of a program, the request Quit with button ’+’ is
displayed. Press the
KEY (+) to unlock the door. After unlocking the door
audible, you can open the door and remove the sterilized items.
For connected output medium and Immediate output Yes a logging
Page 28
Chapter 4 – Sterilization
28
printout is additionally carried out (see page 32, Automatic immediate
log output.
Condensate residues on the
sterilized items
If you remove the →sterilized items from the autoclave directly after the
end of the program, it can happen that slight quantities of condensate
moisture are found on the sterilized items.
S
maller quantities of water which may be are found on the upper side of
the paper bag
s and clear plastic sterilization packages are
unobjectionable if they dry out within 30 minutes after removal from the
autoclave.
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
■
Protected from damage on smooth surfaces
■
Protected from excessive fluctuations in temperature
■
Protected from moisture (e.g. alcohol, disinfectant)
Storage duration in accordance with the type of package wrapping
Storage time
The maximum storage life depends on the packaging and the storage
conditions.
For →sterilized items which have been wrapped in
compliance with the standards (dust
-protected storage is assumed) – this
time period is up to six months.
Page 29
29
Chapter 5 – Logging
In this chapter you learn
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 autoclave
Batch documentation
The batch documentation is indispensable as documentation for the
successfully completed sterilization process and as an obligatory
measure of quality assurance (
→Medical Devices Operator Ordinance).
The data, such as type of program as well as
→batch and process
parameters of the completed programs, are stored in an in
ternal log
memory of the autoclave.
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
log memory
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 immediate
output
is set to No (see also Page 32, Automatic immediate log
output
), a confirmation prompt appears before the saved record is
overwritten. For additional information on connecting the printer, see
page
30, Connect printer .
Output media
You can store the logs of the completed programs on the following output
media and archive them accordingly.
Log printer MELAprint®42
MELAflash CF Card Writer on CF card
Computer, e.g. with software MELAwin®/ MELAview®
MELAnet Box
Modem
State on initial delivery
No option for the output of the logs is set in the initial delivery state of the
autoclave. You can read below how to output the logs on the cited media.
Set date and time
Observe time re-settings
Date and time of the autoclave must be correctly set for proper batch
documentation.
Observe the time re-settings in autumn and spring
("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
of the KEYS (+) and (-).
The display shows
Function: Last batch number.
Navigate with the KEY (+) or (-) in the Menu Function, up to the
display Function: date/ time are displayed.
Page 30
Chapter 5 – Logging
30
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.
The 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).
The current preset value on the display no longer blinks
In orde
r to adjust the other parameters, proceed analogously.
After finishing the settings, press the KEY (S) in to leave the menu
On the display, the
Function: Date/Time are again displayed
By pressing the key (S) again you leave the menu completely and the
display again shows its starting position.
Use printer as output medium
If you want to employ the
log printer MELAprint®42 as the output
medium, connect it to the autoclave as follows:
Data connection
from the autoclave
Open the white cover of the serial data- and printer connection (see page
10
, Fig. 1/ (6)):
(1)
(2)
Turn a coin by a quarter-revolution inserted in the locking slot (1) on
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
autoclave.
If the printer or a computer is continually connected to the autoclave, the
data connect
ion cable of the log printer is laid in the cable ducts (2), the
metal casing retracted and the cover is closed again. This provides a
comfortable external cable connection to the printer.
Close the log printer MELA
print®42 according to the pertinent operating
manual.
Connect printer
Initialisation of the log
printer
MELAprint
®
42
In order to be able to print out logs on the connected log printer, you
must initialise MELA
print®42 once by making the following setting at the
autoclave:
If the autoclave is still not switched on, switch it on.
Wait until the display shows the basic settings (page 12, 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
Page 31
Chapter 5 – Logging
31
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 confirm and return to the menu
Function: Batch output.
After renewed pressing of the KEY (S) the display again shows the
initial state.
Test outputs on the
log printer
MELAprint®42
In order to verify the functional reliability of the log printer MELAprint®42
and its communication wit
h the autoclave, a test output can be carried
out:
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.
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
EY (S). The display shows Function:
Batch output.
By again pressing the KEY (S), you completely leave the menu and
return to the starting position of the display.
Employing MELA
flash as output medium
The MELAflash CF Card Writer serves for storage of sterilization logs on
the MELA
flash CF card. The readout of the logs from the CF card to the
practice computer is carried out with the MELAflash card reader.
Additionally you can use the software MELA
view® for processing the
logged data.
TIP
You can download a current version of the software on the internet page
of MELAG
on www.melag.de in the download area.
Connect the MELA
flash CF Card Writer with the serial interface like the
log printer MELA
print®42 (see page 30). and set at the autoclave as
output medium
MELAflash in the SETUP Menu.
You will find detailed information in the operating manual for the
MELAflash CF Card writer itself.
NOTICE:
Naturally you can also allow the MELA
flash CF Card Writer to be
connected permanently to the autoclave like the log printer
MELA
print®42.
Page 32
Chapter 5 – Logging
32
MELA
net Box as output medium
The MELAnet Box enables the connection of the autoclave 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 MELAnet Box on the computer.
In the MELA
net Box there runs a small webserver program, which
displays status information of the c
onnected autoclave and settings for
the MELA
net Box via a webbrowser. Thus you can allow the display 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
print®42 (see page 30) and set at the autoclave as output medium
MELAnet
in the SETUP Menu Function.
You will find detailed information in the operating
manual for the
MELA
net Box itself.
Computer as output medium
Initialisation of the
computer
In order to be able to employ a computer as output medium, the
computer must be connected with the serial interface to the autoclave.
Additionally the
software MELAview® can be installed for the log readout.
In order to register the computer at the autoclave, proceed as described
on page
30, Initialisation of the Log Printer.
Observe that for the output medium in the SETUP Menu
Function you
must set at the autoclave as output medium
Computer.
Automatic immediate lo
g 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
Immediate output Yes. This is not preset in the initial
delivery state.
Prerequisite for
automatic
immediate output of the logs
after the end of the program
The following prerequisites must be satisfied for the immediate log output
after the end of a program:
As output medium the computer, the log printer MELAprint®42 or the
MELAflash CF Card Writer must be connected and initiated.
This sets the option for an immediate output of the logs after the end of
the program:
Switch the autoclave 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.
In order to save the setting and to leave the menu again, press the
KEY
(S). The display shows
Function: Batch output.
Page 33
Chapter 5 – Logging
33
By again pressing the KEY (S), you leave the menu completely and
return back to the initial state.
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
message appears. MELAG recommends that you employ the
immediate output of logs.
Output the logs
subsequently
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:
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).
The Menu Batch output – Output medium is displayed.
Navigate with the KEY (+) or (-) until the display
Last cycle output: No. 40 is shown (as example No. 40).
Press the KEY (P). The current report number blinks.
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.
After finished printout, the display changes again to its previous setting
Last cycle output: No. 25
.
In order to output additional logs, repeat the last three steps.
In order to leave the submenu without outputting, press
the KEY (S).
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.
Print all saved logs
In order to subsequently output all saved logs, proceed as follows:
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.
After finishing the output the display again shows
Output stored
cycles
.
In case you would like to leave the submenu without printing, press
the K
EY (S).
Page 34
Chapter 5 – Logging
34
NOTICE:
A termination
during the output on the log printer is only possible by
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
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.
Delete stored logs
In order e.g. to suppress the warning text Protocol memory full for
preset option
Immediate output No, the saved logs can be manually
deleted.
In the following example you can read how you can delete all saved logs.
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 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
Function: Batch output.
By again pressing the KEY (S), you completely leave the menu and
return to the starting position of the display.
Display protocol
memory
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
autoclave.
Proceed as follows:
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 (-), 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.
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 autoclave type.
Values of the program steps
During the program the program sequence phases are recorded with the
accompanying values for stea
m pressure, temperature and time (relative
to the program start).
Summary
The summary states whether the program was successfully concluded.
Furthermore the values of the required sterilization time, the sterilization
temperature and the pressure includi
ng its maximum deviations are
displayed.
Program
Start-Stop
Program
Start-Stop
Page 35
Chapter 5 – Logging
35
------------------------------------------
MELAG Euroklav 23V-S
------------------------------------------
Header
Program : Universal program
134°C wrapped
Started program
Date 18.10.2007
Time 08:46:39 (Start)
Batch No.: 5
Current date
time at program start
daily batch number
Pre-heating 96.8 °C
Conductivity 7 µS/ cm
Preheating temperature
→conductivity of the →feed water
Start 0.01 29.1 00:00
Pre-vacuum
Evacuation -0.75 29.2 01:37
Steam entry 0.01 83.6 03:15
1.Fractionation
Steam entry 1.01 113.8 04:40
Press. release 0.18 102.1 05:04
2.Fractionation
Steam entry 1.01 117.9 06:03
Press. release 0.19 103.6 06:33
3.Fractionation
Steam entry 1.01 119.7 07:29
Press. release 0.19 105.2 08:03
4.Fractionation
Steam entry 1.01 120.2 09:01
Press. release 0.19 105.6 09:38
5.Fractionation
Steam entry 1.01 120.0 10:34
Press. release 0.19 105.6 11:13
Heat up 2.04 134.1 13:22
Steriliz.begin. 2.04 134.1 13:22
Steriliz.end 2.17 135.7 18:52
Press. release 0.49 116.2 19:23
Current-drying
Drying begin. 0.49 116.2 19:23
Drying current 0.39 108.8 19:42
Drying pumping 1.21 110.4 20:22
Vacuum-drying
Drying begin. 1.20 103.7 34:04
Drying sub atm. -0.51 96.4 35:14
Drying pumping 0.61 102.7 36:12
Drying end 0.60 102.5 43:52
End 0.02 100.4 44:14
Values of the program steps
Program sequence phases with
the accompanying
values for pressure, temperature and time (relative
to the program start)
------------------------------------------
Summary
Program properly executed!
Control message
Temperature : 135.8 +0.6 /-0.6 °C
Pressure : 2.19 +0.06/-0.05 bar
Sterilizate time: 5 min 30 s
Time of day : 09:30:53 (End)
==========================================
Mean sterilization temperature with max.
deviations
Mean sterilization pressure with max. deviations
Sterilization time maintained
Time at the end of the program
7 200703054 4.06 4.06
CRC: 0x1EB3 V1.30A
Information with total-cycle counter, factory serial
number and instrument software version no.
Page 36
36
Chapter 6 – Maintenance
In this chapter you learn
How to clean the autoclave and which cleaning agents are suitable
How to avoid the formation of spots
How to exchange the door seal
What to observe in autoclave maintenance
Cleaning
Weekly inspection of
chamber, door seal,
mounting, chamber sealing
surface
Examine the chamber including door seal and chamber sealing surface
and the mounting for loading (page
20, Load the Autoclave) once
weekly for contaminants, deposits or damage.
In case of contaminations
If you determine any contaminations, draw the existing trays or cassettes
and the associated mounting forwards out of the chamber. Clean the
contaminated parts.
Door seal
The door seal must not be greased or oiled. It should be kept clean and
dry.
Warning!
When cleaning the chamber, the loading mounting, the chamber
sealing surface and the door seal, observe the following:
■
Switch the autoclave 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.
■
First drench the cloth with cleaning alcohol or methylated alcohol and
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
autoclave 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.
Housing parts
Clean the housing parts with neutral liquid cleaners or methylated
alcohol.
Internal storage tank for feed
water
If you provide the feed water supply manually via the internal storage
tank, check for soiling when you refill the feed water. If necessary,
clean
the tank with a cloth and fresh feed water before refilling.
Page 37
Chapter 6 – Maintenance
37
Notice:
Make sure to wipe up and remove any soiling or impurities from the tank
with a cloth without leaving any residues. If dirt particles are only
detached but not actually
removed, they can get into the dirt particle filter
integrated into the drain hose while emptying the wastewater tank.
Non
-observance could impair the service life of the dirt particle filter
and make it necessary to exchange the filter at short notice.
Clean the left side of the water storage tank ( waste water) every two
weeks.
The both chambers are emptied as follows:
Attach the drain hose on a quick-fitting connection (left of the waste-
water tank, to the right of the feed-water tank), until this perceptibly
engages
Drain off the water into a container with at least 5 litres holding
capacity.
To remove the drain hose again, press the grey release knob at the
quick
-fitting connection. The hose detaches itself automatically from the
connec
tion.
To remove the drain hose again, press the grey release knob at the
quick
-fitting connection. The hose detaches itself automatically from the
connection.
Warning!
Please observe the following when removing the quick-fitting
connection:
■ When draining the storage chambers, stand to the side of the
connection
■ Be sure to hold the hose tight with the other hand while pressing on
the grey release button of the quick-fitting connection in order to
arrest the spring tension of the connection.
Non-observance can lead to injuries.
Repeat the procedure for the other chamber if necessary.
Operation with feed water
circulatory system
If the autoclave is operated in the feed water circulatory system, the feed
water must be changed every week.
Avoid
formation of spots
Formation of spots due to
improperly cleaned
instruments
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
sure during the sterilization. Detached dirt
residues (e.g. residues of disinfectants) can clog the filter, nozzles and
valves of the autoclave and deposit as stains, spots or discolorations on
the instruments and in the chamber (
see page 19, Prepare items to be
sterilized
).
Formation of spots due to
third-party rust
All steam-conducting parts of the autoclave are made of non-rusting
materials.
This excludes the formation of rust caused by the autoclave.
Should rust stains occur, then we are dealing with third
-party rust.
If the instruments have been incorrectly prepared, rust can form even on
stainless steel inst
ruments of leading manufacturers. Often a single rust-
producing instrument already suffices for third
-party rust to form on the
other instruments or in the autoclave.
Remove third
-party rust from the instruments with a chlorine-free
→
stainless steel cleaning agent (see page 36, Cleaning) or send the
damaged instruments to the m
anufacturer for reconditioning.
Page 38
Chapter 6 – Maintenance
38
Formation of spots due to
inade
quate quality of the
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
-grade feed water
Warning!
Observe the following when using →feed water for the steam sterilization:
■ Use only →demineralized or distilled water according to →DIN EN
13060, Appendix C (VDE 0510).
In case of non-observance, stains or damage on the instruments
can arise and the functional readiness of the autoclave can be
adversely affected.
Water according to VDE
0510
You can also use distilled or demineralized water from do-it-yourself
markets, pharmacies or service stations as
→feed water, if the →VDE
0
510 is explicitly noted on the label of the packaging.
NOTICE:
→
Feed water which you can inexpensively produce with the osmosis
processes with MELA
dem®40 or with the ions exchanger MELAdem®47
or by distillation with MELA
dest®65, satisfies the requirements on the
feed water.
Exchange the door seal
If the door seal shrinks or is wavy, it is necessary to exchange the door
seal.
The consequence can be
poorly sealed areas which can lead to the
leakage of steam or cause
a too high leakage rate in the vacuum test.
Open the door of the autoclave and take the old door seal out. The door
seal is only inserted in the groove of the door plate (page
11, Fig. 2/(5)).
Set the new
door seal (Art. No. 58510) in the groove in such a way, that
the
wider sealing surface shows toward the chamber side.
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.
Maintenance
Warning!
■ Have maintenance carried out only by trained field service
technicians or technicians of the specialist trade. Turn to your
specialist dealers or MELAG customer service in your vicinity.
■ Comply with the predetermined maintenance intervals.
Malfunctions at the autoclave can occur on continuation of
operation despite the servicing message.
For retention of value and
Regular maintenance is indispensable for the retention of value and the
reliable practice operation of the autoclave.
Page 39
Chapter 6 – Maintenance
39
functional reliability
During maintenance, all functional and safety-relevant components and
electrical facilities are chec
ked, and replaced if necessary.
The m
aintenance is carried out according to the maintenance instructions
which are relevant for this autoclave.
Maintenance intervals
Regularly allow for maintenance after each 1000 program cycles or two
years.
NOTE
National pressure vessel requirements
may ask the user of pressure
vessel, such as autoclaves, to carry out safety inspections. Please check
the download area from our web
site and find our recommendation in
accordance with German requirements. Fore more information ask you
r
local authorities
.
Page 40
40
Chapter 7 – Operating pauses
In this chapter you learn
How quickly you can start sterilization programs in sequence
What you must observe for longer operating pauses
How to put the autoclave out of operation, transport it and re-start it
Sterilization frequency
No pause times
required
Pause times between the individual programs are not necessary. After
the expiration or termination of drying and removal of the items to be
sterilized, you can immediately re
-load the autoclave and start a
program.
Continuous operation can result in an increased development
of steam from the internal storage tank.
The steam is not harmful to the autoclave provided that the minimum
clearance distances of the autoclave were maintained on site at
installation.
To minimise the development of steam we recommend
that you maintain
a pause of 20 min between every two batches.
Pause times
Longer operating pauses
Switch the autoclave off for longer operating pauses, e.g. overnight or on
the wee
kend, and leave the door ajar. The door seal is relieved and
protected
from premature wear. Furthermore it prevents the sticking of
the door seal.
Close
, if available, the water feed of the water treatment unit.
After operating pauses which last longer than two weeks, carry out a
vacuum test and thereafter an empty sterilization with the Quick Program
(see page
42, Chapter 8 – Function test)
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 pellets for a MELAdem® unit.
Door cannot be opened
Door seal is sticking to the
sealing surface
Switch the autoclave on and pull vigorously at
the door to open it.
Function test after pauses
After pauses, carry out the tests described in Chapter 8 – Functional
Tests
, depending on the pause duration.
Page 41
Chapter 7 – Operating pauses
41
Shut-down
If you would like to shut down the autoclave (put it out of operation) for a
longer period of time, for instance because of
holidays or a planned
transport, proceed as follows:
Switch the autoclave off at the mains switch.
Pull the power plug from the wall socket.
Empty both chambers of the storage tank
Close, if available, the water feed of the water treatment unit.
Transport
Danger of injury!
Observe the following when carrying the autoclave:
■ Two people are necessary to carry the autoclave.
■ Use a suitable carrying strap to transport the autoclave.
Observe that the spacing between the underside of the housing floor
plate of the autoclave and the footprint is small.
In case of non-
observance spine damage and contusions can result.
Warning!
Observe the following when transporting the autoclave, e.g. when
moving or shipping the autoclave or for the transport within the
practice:
■ Empty both chambers of the storage tank
■
When using a water treatment unit, close the water feed and removal
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 autoclave before you move the device.
In case of non-observance, damages to the a
utoclave and errors can
occur.
Re
-startup after change of locality
At re-startup of the autoclave after a change of locality, proceed as for an
initial start
-up (see page 14, Chapter 3 – Initial start-up).
Page 42
42
Chapter 8 – Function test
In this chapter you learn
How the autoclave 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 display the water quality
Automatic function test
Process evaluation and
monitoring system
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 autoclave compares the process
parameters with each other during the program and monitors them with
respect to their limit values.
The monitoring system of the autoclave checks the device components
with regard to their functional reliability and their plausible interaction. If
the p
arameters exceed defined limit values, the autoclave outputs
warni
ng messages or error messages. If necessary, it 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
29,
Chapter
5 – Logging).
Page 43
Chapter 8 – Function test
43
Testing in daily operation
Vacuum test
Weekly in routine operation,
at initial start-
up, after
pauses longer than two
weeks and in case of error
Conduct a vacuum test in the following situations:
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)
The test serves to determine leaks in the autoclave.
The leakage rate is determined.
Conduct the vacuum test with a cold and dry autoclave as follows:
Switch the device on at the mains switch. The display switches into
its initial state.
Press the KEY (P) until the menu Vacuum test is shown in the
display.
Close the door. This is confirmed with the appropriate display Door
closed.
Press the KEY (S), in order to start the vacuum test.
The chamber is
→evacuated until the pressure for the vacuum test is
achieved.
An equilibration time of five minutes and a measurement time
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 ≤ 1.3
mbar, an appropriate message appears on the display.
B
esides the display shows in alternation with the current batch number of
the day and
Quit with button ’+’. After pressing the KEY (+) you
can open the door.
NOTICE:
For connected log printer or another output medium and the setting
Immediate output Yes
logging is carried out with simultaneous
printout.
Bowie & Dick test
The →Bowie & Dick test serves the verification of the steam penetration
of porous materials such as
textiles.
For this purpose, use the test program
→Bowie & Dick test.
Diverse test systems are offered by specialist dealers for the
→Bowie &
Dick test.
Conduct the test according to the manufacturer's instructions of
the test system.
Start the program Bowie & Dick test as follows:
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.
After successful completion of the program the display shows in
Page 44
Chapter 8 – Function test
44
alternation with the current batch number of the day and Quit with
button ’+’
. After pressing the KEY (+) you can open the door.
Display water quality
You can at all times have the display of water quality shown on the
switched on the autoclave, also during a running program.
To do this keep the
KEY (-) pressed until the display shows the
→
Conductivity. The conductivity is stated in µS/ cm.
As soon as you release the
KEY (-) the display returns to its previous
status (e.g. initial state).
Pre-heating temperature of
the chamber
If you press the KEY (-) twice shortly and the second time keep it pressed,
the pre
-heating temperature of the chamber is shown instead of the
→
Conductivity.
Page 45
45
Chapter 9 – Errors
In this chapter you learn
Which type of messages exist
What 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
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
autoclave or while a program is running.
The program is aborted if a malfunction occurs during a program run.
Danger of infection!
■ If a program is aborted during the sterilization phase, the load is
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.
The error message is then shown on the display. in alternation with the
current program phase (
Pressure release, Ventilation or End)
After the program abort or termination, the error message is shown on
the display in alternation with the
message Acknowledge with
button
"-" and Program stopped. In order to delete the error
message, press the
KEY (-).
Page 46
Chapter 9 – Errors
46
Before you call
Follow the operating procedures shown in connection with a warning text
or an error message on the
→display of the autoclave. You will find the
most important
events in the following table. Possible causes and
appropriate operating instructions are listed
for the events.
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 number of y
our autoclave and a detailed fault description of the
fault report ready.
Warning message
Possible causes
What you can do
Warning: Door open /
No start possible
Door switch is not closed on
start
Push the sliding closure grip downwards until
the stop. Correct display: Door closed
Warning: No feed water/
Refill feed water – No start
possible
Only if feed water supply from
internal storage tank:
not enough feed water in the
internal storage tank
Check feed water level in the internal storage
tank check, if necessary refill feed water
Warning: No feed water/
Check feed water quality
The warning message appears
after program start. The built-in
flow monitor doesn't close
Feed water supply from internal storage
tank:
If the message appears repeatedly, have the
unit checked by the MELAG customer service
Feed water supply from MELAdem
®
40
Check water treatment unit, possibly open
inflow to the unit.
If the message appears repeatedly, have the
unit checked by the MELAG customer service
Feed water-supply from MELdem
®
47
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-start-up, this
message can occur once since the piping
system is still not completely filled: restart
Attention – empty the
wastewater tank / No start
possible
left chamber of the storage tank
(wastewater side) is full
Empty the left chamber of storage tank
(wastewater side), see page36, Chapter 6 –
Maintenance
Feed water quality bad/
exchange cartridge/ module
Conductivity of the feed water
too high
Conductivity ≥ 40 µS
Still possible to start by repeatedly pressing
the KEY (S):
Feed water-supply from internal storage
tank:
with one-way-system:
Empty the right chamber of the storage tank,
clean, rinse with fresh feed water and fill fresh
feed water of thr respective quality into the
chamber up to the MAX mark.
Page 47
Chapter 9 – Errors
47
Warning message
Possible causes
What you can do
with circulatory system:
Empty both of the chambers of the storage
tank, clean, rinse with fresh feed water and fill
fresh feed water of the respective quality into
the chamber up to the MAX mark.
Feed water supply from the water treatment
unit:
Mixed-bed resin pellets
consumed
MELAdem®40:
Switch the mixed-bed resin pellets (Art. No.
61026) ,see Operating Manual for the water
treatment unit MELAdem
®
40
Mixed-bed resin pellets in the
after ion exchanger
(3rd cartridge) consumed
MELAdem®47:
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.
Mixed-bed resin pellets in
reverse osmosis facility
consumed
For another water treatment unit:
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 maintenance of the water treatment unit,
this warning text can appear once again since
the inlet hose/ measuring cell are still not
completely flushed with fresh water
Feed water quality
insufficient/ No start
possible
Conductivity of the feed water
too high
Conductivity ≥ 65 µS
Start no longer possible:
See warning message: Feed water quality bad/
switch cartridge/ module
Please wait
Preheating chamber
Message is displayed during
program start phase. The
autoclave has not reached the
starting temperature yet.
The autoclave starts automatically after
reaching the starting temperature.
Warning/ Exchange sterile
filter
min. / max. pressure on
ventilation drying is too low/
high
Sterile filter polluted or torn
Exchange sterile filter (Art. No. 20160)
NOTICE: Message comes at the end of the
program and in last row on logging printouts.
Output medium is not ready
The autoclave is operated
without output
medium although
a output medium is registered
Select the option in the menu Batch output
No output medium ( see page 30,
Initialization of the log printer)
Page 48
Chapter 9 – Errors
48
Warning message
Possible causes
What you can do
Output medium is not correctly
connected
Correct connection of the data cable to the
autoclave and test at the output medium.
Electric power supply of the
printer is interrupted
Printer is "offline"
Ensure electric power supply, the red LED "P"
at the log printer MELAprint®42 must light red
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 allocated (max. 40 logs
possible).
The message is shown at the start of a
program.
Repeatedly press the KEY (S) to delete the
message, and the program starts. The oldest
log is then deleted.
An output medium is registered
and in the menu Batch
output the option
Immediate
output No is set.
Set printer to Immediate output Yes (see
page 32, Automatic immediate log output)
Delete printer memory (see Page 34, Delete
stored logfiles, possibly output all stored logs
beforehand (see page 33, Print all saved logs
)
Log off the output medium in the menu batch
output output medium
and set the option
no output medium.
Please carry out
maintenance
The maintenance message is
activated, the device has
reached the prescribed batch
number
The message is shown at program start.
Repeatedly press the KEY (S) to delete the
message, and the program starts.
Retain the message: press the (S) key twice to
start
Carry out maintenance with MELAG customer
service or service of the specialist trade
NOTICE: Service counter is reset by the
customer service
Test not successful
Leakage rate: 3.2
The leakage rate determined by
the vacuum test lies above the
maximum permissible value of
1.3 mbar.
Door seal, chamber flange is
contaminated
Check door seal and chamber flange for
cleanliness, possibly clean
Check door seal for damage, possibly
exchange, see page 11
Repeat vacuum test with completely cold
device
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
internal battery voltage has
determined a too low voltage
value.
The battery must be exchanged by MELAG
customer service or service of the specialist
trade
Page 49
49
Error message
Possible causes
What you can do
Error 1: Vacuum system
Door seal, sealing surface at
the chamber is polluted or
defective
Check door seal and sealing surface at the
chamber for contamination and clean it;
Check door seal for defects, possibly
exchange, see page 11
Door seal wrongly inserted
Check door seal for correct seating
Check the correct set-up of the autoclave.
Check the autoclave for fallen instruments, filter
paper etc. which might be lying on the chamber
floor
Error 2: Steam generator
autoclave is overloaded
Decreased heating power, since
supply voltage too low
Pay attention to the correct loading quantities
(see page 20, Load autoclave)
Check building-side electrical Installation,
operate device on a trial basis on another
electric circuit.
Avoid water collecting in the items to be
sterilized; bowls, cups and glasses upside
down
Cassettes perforated on one side must be
placed with the perforate side downwards.
Press the reset button for overheating
protection (Fig. 1/(8) and start the QuickProgram S without any load.
If problem persists, notify specialist dealers
Error 4: Pressure release
Pressure release filter is soiled
Check whether the pressure-release filter is
clogged (in chamber bottom in the rear area).
Beforehand, unscrew the filter.
On repeated occurrence notify your specialist
dealer
Error 8:Time-base
Maximum difference between
the program cycle time and the
internal computer clock is
exceeded
On repeated occurrence notify your specialist
dealer
Error 9: Door open!
The locking sliding handle was
pushed upwards during a
running program
Push the sliding closure grip downwards until
the stop. Correct display: Door closed
On repeated occurrence notify your specialist
dealer
Error 10: Overheat Steam
generator
Capillary tube regulator "level
control" is opened at program
start (error message
immediately after start) or
during a program run (until the
end of the sterilization) the
monitoring time until the
capillary tube regulator is
switched back (with water feed
from feed water) is exceeded
After program termination and immediate start,
this error message can be repeated after a
pause time of two minutes
On repeated occurrence notify your specialist
dealer
Page 50
Chapter 9 – Errors
50
Error message
Possible causes
What you can do
Error 12: Door locking
Locking pin of the door is stiff
Check the smooth running of the door locking
pin
On repeated occurrence notify your specialist
dealer
Error 14: No feed water
see warning text Warning no feed water,
however this error appears after the start of a
program
Error 18: Sensor: ...Input:
…
The device-internal inspection
of 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
On repeated occurrence notify your specialist
dealer
Error 21: Preheating
The monitoring time from
switching on the pre-heating
until the achievement of the
respective pre-heating
temperature was exceeded
On repeated occurrence select option
Automatic pre-heating No ( see page
23) and notify specialist dealers
Error 22: Overheat
Preheating
The maximum preheating
temperature was exceeded
On repeated occurrence select option
Automatic pre-heating No ( see page
23, Select automatic pre-heating) and notify
specialist dealers
Error 23: Current
Monitoring time for the pressure
release
in the outflow procedure
during fractionations was
exceeded
Flow filter soiled
Check flow filter lower front in the chamber floor
On repeated occurrence notify your specialist
dealer
Error 26: A/D converting
The maximum admissible
deviation of the computerinternal signal conditioning (A/D
converting) was exceeded
On repeated occurrence notify your specialist
dealer
Error 27: Temp.Sens. def
1.2
The maximum admissible
deviation between the two
temperature sensors for the
steam temperature was
exceeded
On repeated occurrence notify your specialist
dealer
Error 31:System leak
During the program vacuum test
the permitted pressure
maximum was exceeded (very
large leak) after achieving the
evacuation pressure
Repeat vacuum test,
if renewed error message, notify specialist
dealers
Error 32: Power loss /
Sterilize sterile filter
The loss of the operating
voltage occurred after the start
of a program
The error message occurs after the operating
voltage is again available
Check building-side installation, If no defects
are detectable, notify MELAG customer service
In the event of power failure after a program
Page 51
Chapter 9 – Errors
51
Error message
Possible causes
What you can do
has been started in overpressure, an additional
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
autoclave,
sterilize the filter in the Quick Program,
after the expiration of the program, plug in the
filter again
Disconnection of the autoclave
during a running program
Only terminate a running program with KEY (S)
(see also page 25, Manually terminate
program )
Error 33: Pressure drop
The maximum switch-on time of
the steam generator for
achieving the control pressure
was exceeded
On repeated occurrence notify your specialist
dealer
Error 34: Sterilization TU1
Shortfall of the minimum
permissible sterilization
temperature
(temperature sensor 1)
Operate device with smaller load, possibly
carry out vacuum test
Check door seal for wear
On repeated occurrence notify your specialist
dealer
Error 35: Sterilization TO1
Exceeding the maximum
permissible sterilization
temperature
(temperature sensor 1)
Carry out vacuum test
On repeated occurrence notify your specialist
dealer
Error 36: Sterilization PU
Shortfall of the minimum
sterilization pressure
Operate device with smaller load, possibly
carry out vacuum test
Check door seal for wear
On repeated occurrence notify your specialist
dealer
Error 37: Sterilization PO
Exceeding the maximum
permissible sterilization
pressure
On repeated occurrence notify your specialist
dealer
Error 38: Sterilization TD1
Maximum permitted difference
between theoretical
temperature, quoted from the
pressure signal, and the
temperature measured at the
temperature senor 1 was
exceeded
On repeated occurrence notify your specialist
dealer
Error 41: Current drying
Flow filter soiled
Check flow filter lower front on the chamber
(right behind the door)
On repeated occurrence notify your specialist
dealer
Page 52
Chapter 9 – Errors
52
Error message
Possible causes
What you can do
Error 42: Drying press.
pump
Sterile filter soiled
Check sterile filter, exchange if necessary
On repeated occurrence notify your specialist
dealer
Error 43: Drying vacuum
pump
Flow filter soiled
Check flow filter lower front on the chamber
(right behind the door)
On repeated occurrence notify your specialist
dealer
Error 51: Sterilization TU2
Shortfall of minimum
permissible sterilization
temperature (temperature
sensor 2)
Operate device with smaller load, possibly
carry out Vacuum test.
Check door seal for wear.
On repeated occurrence notify your specialist
dealer.
Also see Error 34
Error 52: Sterilization TO2
Exceeding the maximum
permissible sterilization
temperature (temperature
sensor 2)
Carry out vacuum test
On repeated occurrence notify your specialist
dealer.
Also see Error 35
Error 53: Sterilization TD2
Maximum permitted difference
between theoretical
temperature, quooted 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 38
No display on the screen
After switching on the autoclave the display remains empty.
What you can do
Check whether the power plug is correctly in the socket.
Check the supply voltage at the socket.
If necessary, switch the instrument securing at the lower front of the
autoclave (see page
10, Fig. 1/(7))off. Follow the instructions in the
technical manual in Exchange device fuses.
Too
large feed water consumption
The feed water consumption is dependent upon the program and the
loading of the autoclave.
What you can do
Check the correct set-up of the autoclave.
The floor of the vessel must be free. Where applicable, remove
fallen instruments, filter paper, etc.
Bad drying results
Apart from a proper device function, the drying process depends
decisively on the correct setting up and loading of the autoclave.
What you can do
Check the correct set-up of the autoclave.
The floor of the vessel must be free. Where applicable, remove
Page 53
Chapter 9 – Errors
53
fallen instruments, filter paper, etc.
The tank filter is clogged. If necessary, check and clean it.
Pay attention to the correct loading of the autoclave (see page 20
Load the autoclave).
Do not overload the autoclave. Pay attention that textiles have no
direct contact with the chamber wall and floor.
Activate the pre-heating (see page 23,Select automatic pre-
heating)
Employ the function Additional Drying (see page 24, Additional
Drying).
Page 54
54
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
Bowie & Dick test
Steam penetration test with standard testing packet;
described in →DIN EN 285; test is recognised for largescale 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 (
µS/cm); the
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
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
sterilization; typical values for the water quality according
to →DIN EN 285 or →DIN EN 13060 – Appendix C, at
least however battery water according to →VDE 0510
Page 55
Glossary
55
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 flow method
Overpressure method in which the air is expelled from the
chamber and the items to be sterilized by alternating
between steam entry and steam outlet.
Heating-up period
After switching on the autoclave 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 bodies A
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 diam
Hollow bodies B
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]
Initialization
Creation of a certain initial state of the →software at startup
Integrated steam generation
The steam generator is located directly on the floor of the
sterilization chamber
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
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)
Pre-vacuum method
iIn contrast to the fractionated vacuum method, a vacuum
is created only once to remove the air from the sterilization
chamber; not so suitable for complicated hollow bodies
such as Type A
Process evaluation system
Also self-monitoring system – observes itself, acts during
the programs, compares sensors with each other
Pulsating overpressure drying
Drying method which removes moisture from the chamber
and the items to be sterilized by alternating between air
entry and discharge.
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 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
[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
Page 56
Glossary
56
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
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)
VDE 0510
Standard of the →VDE – Provisions for accumulators and
battery units
Page 57
57
Appendix A – Accessories
Article
Order number*
Euroklav®23 VS+
Euroklav®29 VS+
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
Sterilization containers
with single-use paper
filters according to DIN
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
Swab drums with filter
cloth
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
00289
without filter cloth
00286
Trays
tray
00230
00280
Water treatment units
MELAdem®40 ion exchanger
01049
MELAdem®47 reverse-osmosis unit
01047
For the
documentation
MELAflash CF Card printer incl. MELAflash CF
card and card reader
01039
MELAnet Box
40296
MELAprint®42 log printer
01042
Other
Water stop valve
01056
Surface-mounted siphon
37410
Device fuses 16A/ gRl
57592
*All specified articles are available at the specialist dealers
Page 58
58
Appendix B – Symbols on the
autoclave
The manufacturer of the apparatus declares with the accompanying
sticker that the medical device corresponds to the basic requirements of
the European Standard EN1717
– "Protection of drinking water from
contaminants…."
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 the marketing party.
With the designation of an apparatus with this symbol, the manufacturer
furthermore declares th
at he satisfies all requirements of the law
concerning the release, withdrawal and environmentally compatible
disposal of electric and electronic appliances.
With the CE sign, the manufacturer declares that the medical device
corresponds to the basic requirements of the German Medical Device
Guideline. The four
-digit number means that an approved certification
body
monitors the product certification.
With the CE sign, the manufacturer declares that the medical device
corresponds to the basic requirements of the German Printing Device
Guideline. The four
-digit number means that an approved certification
body
monitors the product certification.
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