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MELAG

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0% found this document useful (0 votes)
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MELAG

Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 64

User Manual

Euroklav® 23 VS+
Euroklav® 29 VS+
Steam sterilizer
from software version 5.21

EN
Dear customer,
We thank you for your confidence demonstrated by the purchase of this MELAG product. As an owner-run and operated
family concern founded in 1951, we have a long history of successful specialization in hygiene products for practice-
based use. Our focus on innovation, quality and the highest standards of operational reliability has established MELAG
as the world’s leading manufacturer in the instrument reprocessing and hygiene field.
You, our customer are justified in your demand for the best products, quality and reliability. Providing “competence in
hygiene” and “Quality – made in Germany”, we guarantee that these demands will be met. Our certified quality
management system is subject to close monitoring: one instrument to this end is our annual multi-day audit conducted in
accordance with EN ISO 13485. This guarantees that all MELAG products are manufactured and tested in accordance
with strict quality criteria.
The MELAG management and team.

0197
Contents

Contents
1 General guidelines ............................................................................................................................................................... 5
Symbols used ...................................................................................................................................................................... 5
Formatting rules................................................................................................................................................................... 5
Disposal ............................................................................................................................................................................... 5

2 Safety..................................................................................................................................................................................... 6

3 Performance specifications ................................................................................................................................................ 8


Intended use ........................................................................................................................................................................ 8
Sterilization procedure ......................................................................................................................................................... 8
Type of the feed water supply.............................................................................................................................................. 8
Safety equipment................................................................................................................................................................. 9
Performance characteristics of sterilization programs ......................................................................................................... 9
Program sequences........................................................................................................................................................... 10
Overview of programs........................................................................................................................................................ 11

4 Description of the device................................................................................................................................................... 13


Scope of delivery ............................................................................................................................................................... 13
Views of the device............................................................................................................................................................ 14
Symbols on the device....................................................................................................................................................... 15
Operating panel ................................................................................................................................................................. 16
Load mounts ...................................................................................................................................................................... 17

5 First steps ........................................................................................................................................................................... 18


Setup and installation ........................................................................................................................................................ 18
Feed water supply ............................................................................................................................................................. 18
Wastewater connection ..................................................................................................................................................... 19
Switching on the steam sterilizer ....................................................................................................................................... 19
Opening and closing the door............................................................................................................................................ 19
Setting the date and time................................................................................................................................................... 20

6 Sterilization ......................................................................................................................................................................... 21
Preparing the load ............................................................................................................................................................. 21
Loading the steam sterilizer............................................................................................................................................... 22
Selecting the program........................................................................................................................................................ 24
Additional program options ................................................................................................................................................ 25
Starting the program .......................................................................................................................................................... 26
Program run....................................................................................................................................................................... 26
Program end ...................................................................................................................................................................... 27
Manual program abort ....................................................................................................................................................... 27
Removing the sterile material ............................................................................................................................................ 29
Storing sterile material ....................................................................................................................................................... 29

7 Logging ............................................................................................................................................................................... 30
Batch documentation ......................................................................................................................................................... 30
Output media ..................................................................................................................................................................... 31
Outputting logs immediately and automatically ................................................................................................................. 33
Subsequent log output....................................................................................................................................................... 34
Displaying the log memory ................................................................................................................................................ 35
Contents

Deleting logs in the internal log memory............................................................................................................................ 36


Reading logs correctly ....................................................................................................................................................... 36

8 Function checks ................................................................................................................................................................. 38


Automatic functional checks .............................................................................................................................................. 38
Manual functional checks .................................................................................................................................................. 38
Vacuum test....................................................................................................................................................................... 38
Bowie & Dick test............................................................................................................................................................... 39
Checking the quality of the feed water............................................................................................................................... 39
Pre-heating temperature of the sterilization chamber........................................................................................................ 39

9 Maintenance........................................................................................................................................................................ 40
Servicing intervals.............................................................................................................................................................. 40
Cleaning............................................................................................................................................................................. 40
Avoiding staining................................................................................................................................................................ 42
Replacing the door seal ..................................................................................................................................................... 42
Replacing or sterilizing the sterile filter .............................................................................................................................. 43
Cleaning the filter in the sterilization chamber ................................................................................................................... 45
Maintenance ...................................................................................................................................................................... 45

10 Pause times ...................................................................................................................................................................... 46


Frequency of sterilization................................................................................................................................................... 46
Operating pauses .............................................................................................................................................................. 46
Decommissioning .............................................................................................................................................................. 46
Transport ........................................................................................................................................................................... 47
Recommissioning after relocation...................................................................................................................................... 47

11 Malfunctions ..................................................................................................................................................................... 48
Warnings............................................................................................................................................................................ 49
Fault messages ................................................................................................................................................................. 52
Opening the door in an emergency following a power outage........................................................................................... 57
Replacing the device fuses................................................................................................................................................ 58

12 Technical data .................................................................................................................................................................. 59

13 Accessories and spare parts .......................................................................................................................................... 60

Glossary ................................................................................................................................................................................. 61
1 General guidelines

1 General guidelines

Please read this user manual carefully before commissioning the device. The manual includes important
safety instructions. Make sure that you always have access to digital or printed version of the user manual.
Should the manual no longer be legible, is damaged or has been lost, you can download a new copy from
MELAG download centre at www.melag.com.

Symbols used
Symbol Description
Indicates a dangerous situation, which if not avoided, could entail slight to life-threaten-
ing injuries.
Draws your attention to a situation, which if not avoided, could result in damage to the
instruments, the practice fittings or the device.
Draws your attention to important information.

Formatting rules
Example Description
see Chapter 2 Reference to another text section within this document.
Universal- Words or phrases appearing on the display of the device are marked as display text.
Program

Disposal
MELAG devices are synonymous with high quality and a long life-span. When you eventually need to
decommission your MELAG device, the required disposal of the device can take place with MELAG in
Berlin. Simply contact your stockist.
Dispose of accessories and consumption media which you no longer require in the appropriate manner.
Comply with all relevant disposal specification in terms of possibly contaminated waste.
The packaging protects the device against transport damage. The packaging materials have been
selected for their environmentally-friendly disposability and can be recycled. Returning the packaging to
the material flow reduces the amount of waste and saves raw materials.
Dispose of spare parts that are no longer used, e.g. seals, properly.
MELAG draws the operator’s attention to the fact that they are responsible for deleting personal data on
the device to be disposed of.
MELAG draws the operator’s attention to the fact that they may be legally obliged (e.g. in Germany
according to ElektroG) to remove used batteries and accumulators non-destructively before handing over
the device, provided they are not enclosed in the device.

5
2 Safety

2 Safety

When operating the device, comply with the following safety instructions as well as those con-
tained in subsequent chapters. Use the device only for the purpose specified in these instruc-
tions. Failure to comply with the safety instructions can result in injury and/or damage to the
device.
Qualified personnel
n As with the preceding instrument reprocessing, only competent personnel should undertake
sterilization using this steam sterilizer.
n The operator must ensure that the users are regularly trained in the operation and safe handling of the
device.
Carrying the steam sterilizer
n The device should always be carried by two people.
n Use the correct carrying straps to carry the device.
Setup, installation and commissioning
n Check the device after unpacking for any damage suffered during transport.
n The device should only be setup, installed and commissioned by MELAG authorised persons.
n The connections for electrical provision and water supply and discharge must be setup by trained
personnel.
n Using the optional electronic leak detector (water stop) minimises the risk of water damage.
n The device is not suitable for operation in explosive atmospheres.
n Install and operate the device in a frost-free environment.
n The device is conceived for use outside the patient area. The device should be located a minimum of
1.5 m radius away from the treatment area.
n The documentation media (computer, CF card reader etc.) must be placed in such a way that they
cannot come into contact with liquids.
n Observe all the information contained in the technical manual during commissioning.
Power cable and power plug
n Comply with all legal requirements and locally-specified connection conditions.
n Never operate the device if the plug or power cable are damaged.
n The power cable or plug should only be replaced by authorised technicians.
n Never damage or alter the power plug or cable.
n Never bend or twist the power cable.
n Never unplug by pulling on the power cable. Always take a grip on the plug.
n Never place any heavy objects on the power cable.
n Ensure that the power cable does not become jammed in.
n Never lead the cable along a source of heat.
n Never fix the power cable with sharp objects.
n The mains socket must be freely accessible after installation so that the device can be disconnected
from the electrical mains at any time if necessary by pulling the mains plug.
Spring safety valve
n The spring safety valve must be able to move freely and not become stuck or blocked. Position the
device in such a way that the faultless functioning of the spring safety valve is guaranteed.

6
2 Safety

Reprocessing and sterilization


n Follow the manufacturer’s instructions of your textile articles and instruments regarding their
reprocessing and sterilization.
n Comply with the relevant standards and directives applicable to the reprocessing and sterilization of
textiles and instruments (in Germany e.g. from the RKI and DGSV).
n Only ever use packaging material and systems which have been cleared by their manufacturer for
steam sterilization.
Program abort
n Please observe that depending on the time of the program abort, opening the door following a
program abort can lead to hot steam leaving the sterilization chamber.
Removing the sterile material
n Never use force to open the door.
n Use a tray lifter to remove the tray. Never touch the sterilized equipment, the chamber, the mount or
the inside of the door with bare hands. The components are hot.
n Check the packaging on the sterile material for damage when removing it from the steam sterilizer.
Should the packaging be damaged, re-pack the load, and re-sterilize it.
Transport and storage
n Store and transport the device in a frost-free environment.
n The device should always be carried by two people.
n Use suitable carrying straps to carry the device.
Maintenance
n Maintenance should only be performed by authorised technicians.
n Maintain the specified maintenance intervals.
n Only original MELAG spare parts may be used.
Repair
n Never open the device housing. Incorrect opening and repair can compromise electrical safety and
pose a danger to the user. The device may only be opened by an authorised technician who must be
a qualified electrician.
Malfunctions
n Should the device issue the same malfunction message repeatedly, turn off the device and if
necessary, inform your stockist.
n The device may only be serviced by authorised technicians.
Notification requirement in the event of serious accidents in the European Economic Area
n Please note that all serious accidents which occur in connection with the medical device (e.g. death or
serious deterioration in the state of health of a patient) which were presumably caused by the device,
must be reported to the manufacturer (MELAG) and the relevant authority of the member state, in
which the user and/or patient resides.

7
3 Performance specifications

3 Performance specifications

Intended use
The steam sterilizer is intended for use in every kind of general medical field where no sterilization cycles
of type "B" are required for the instruments sterilized and the type of packaging used.
According to EN 13060, this steam sterilizer is performing sterilization cycles of type "S". As an universal
steam sterilizer, it is suited for sterilizing wrapped/unwrapped solid instruments, simple hollow items and
small quantities of textiles. The steam sterilizer is not intended for use on patients or in the patient
environment. Typical users are doctors, instructed practice employees and service technicians.

WARNING
Any attempt to sterilize liquids can result in a delay in boiling. This can result in burns
and damage to the device.
n Never use this device to sterilize fluids. It is not licensed for the sterilization of fluids.

Sterilization procedure
The steam sterilizer sterilizes on the basis of the pre-vacuum method combined with the fractionated flow
procedure.
This guarantees the complete and effective wetting/penetration of the load with saturated steam.
The steam sterilizer uses integrated steam generation to generate sterilizing steam. Steam is generated in
the sterilization chamber upon program start. This establishes a pre-defined pressure and a set
temperature. The sterilization chamber is protected against overheating.
You can sterilize instruments or textiles one after the other in a very short time, achieving excellent drying
results.

Automatic preheating
If preheating is activated, the cold chamber is heated up to the preheating temperature of the particular
program before program start, or this temperature is held between two program runs. This reduces
program times and the accretion of condensation, thus improving drying results.

Type of the feed water supply


The steam sterilizer works with both a one-way feed water system and in accordance with the feed water
circulation system. The one-way feed water system uses fresh demineralized or distilled feed water for
every sterilization procedure. The quality of the feed water is subject to permanent monitoring via
integrated conductivity measurement. If the instruments are prepared carefully beforehand, this serves
largely to prevent stain accretion on the instruments and soiling of the steam sterilizer. When using the
feed water circulation system, the steam sterilizer uses less water, as the feed water is used for multiple
sterilization cycles. Here too, the quality of the feed water is subject to permanent monitoring via integrated
conductivity measurement.
The supply with feed water for steam generation is performed automatically via an internal storage tank or
a water treatment unit (e.g. MELAdem 40, MELAdem 47).
The technical manual provides detailed information regarding connection to a water treatment unit.

8
3 Performance specifications

Safety equipment
Internal process monitoring
A process evaluation system is integrated in the electronics of the steam sterilizer. It compares the process
parameters (such as temperature, time and pressure) during a program run. It monitors the parameters in
terms of their threshold values during control and regulation and guarantees safe and successful
sterilization. A monitoring system checks the device components of the steam sterilizer for their
functionality and interplay. If one or more parameters exceeds pre-determined threshold values, the steam
sterilizer issues warning or malfunction messages and if necessary, aborts the program. In the case of a
program abort, follow the instructions on the display.
The steam sterilizer uses an electronic parameter control. This enables the steam sterilizer to optimise the
total operating time of a program in dependence on the load.

Door mechanism
The steam sterilizer constantly checks pressure and temperature in the sterilization chamber and prevents
the door from being opened when over-pressure has built up.

Quantity and quality of the feed water


The quantity and quality of the feed water is automatically checked before every program start.

Performance characteristics of sterilization programs


The results in this table show which inspections were performed on the steam sterilizer. The marked fields
demonstrate compliance with all the applicable sections of the standard EN 13060.
Type tests Universal- Quick- Gentle- Prion-
Program Program S Program Program
Program type in accordance with Type S Type S Type S Type S
EN 13060
Dynamic pressure test of the sterilization X X X X
chamber
Air leakage 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 -- -- -- --
Simple hollow items X X X X
Product with narrow lumen -- -- -- --
Single wrapping X -- X X
Multiple wrapping 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 2.1 bar 2.1 bar 1.1 bar 2.1 bar
Sterilization time 5:30 min 3:30 min 20:30 min 20:30 min
X = Complies with all applicable sections of the standard EN 13060

9
3 Performance specifications

Program sequences
Regular sterilization program
After program start, you can follow the program run on the display. It shows the chamber temperature and
pressure as well as the time until the end of sterilization and drying.

Program phase Description


1. Pre-vacuum phase Air is evacuated in the pre-vacuum and steam is generated in the sterilization
chamber which produces over-pressure.
2. Air removal phase The fractionated flow procedure removes the air from the chamber through puls-
ing repeated steam injection and removal. Depending on the program selected
and the current chamber temperature upon program start, further fractionation
can also follow.
3. Heating phase The heating phase follows the air removal phase. The pressure and temperature
increase until the program-specific sterilization parameters have been reached.
4. Sterilization phase Once the pressure and temperature correspond to the program-dependent nom-
inal values, the actual sterilization phase begins. The sterilization time is indicat-
ed on the display.
5. Pressure release Pressure is released after the end of the sterilization phase.
6. Drying phase The drying phase begins after the pressure release. This is performed in two
stages: flow drying and vacuum drying (pulsing over-pressure drying).

Vacuum test
The vacuum test measures the leakage rate. No real sterilization is performed. The test is performed with
a cold, dry and unloaded device.

Program phase Description


1. Air removal phase The sterilization chamber is evacuated until the pressure for the vacuum test
(evacuation) has been reached.
2. Equilibration time An equilibration time of 5 min will follow.
3. Measurement time The measuring time is 10 min. The pressure increase within the sterilization
chamber is measured during the measurement time. The evacuation pressure
and the equilibration time or measurement time are shown on the display.
4. Test end The display shows the test result and the batchnumber. The number of the total
batches and the leakage rate can also be displayed.

10
3 Performance specifications

Overview of programs
MAIN menu

Function
Initial state - +
(see next page)

Press 1x
hh:mm:ss AIN6: Conductivity
h - - Press simultaneously to reach the SETUP
0.00 bar 89°C
+
10 µS/cm menu function
Release
P h - Select by holding the '-' key depressed

Press 2x + Unlock the door with the '+' key


Universal-Program AIN4: Temp_pre-heat.
134°C wrapped h - 120°C
Release
S+
Additional drying selected

Program run
P
Abort before
Quick-Program S S
START drying
134°C
S Abort prog.?
---------- Program runs ----------

P 'Stop' key
Gentle-Program
S
121°C
Program
P aborted
Abort during
Pressure release
Prion-Program drying
1.52 bar 112°C
134°C wrapped 20'
Abort end
Immediate removal Abort prog.
P 0.02 bar 88°C
press 'Stop' 'Stop’ key
Acknowledge
Bowie & Dick-Test S
with '-' key
134°C 2.2 bar 3.5' Quick-Program S Drying
completed aborted
-
P
Last batch number x Unlock door with
Vacuum test Acknowledge with '+' '+' key

S+ Press the 'S' and '+’ keys simultaneously

S 'Start-Stop’ key and program abort

P Key 'P' [Program]: enter, confirm, entry

11
3 Performance specifications
SETUP menu - Function
12

hh:mm:ss
Initial state
0.00 bar 89°C 1 No output medium
MELAprint

S - + Press both keys simultaneously MELAflash


MELAnet graphic data (MELAnet Box)
2
SETUP menu Computer Applies only to Vacuklav 23 B+/ 31 B+, Euroklav S+/ VS+, Vacuvet 23 B+,
Function: Modem DAC Professional
3
MELAprint 80 Applies only to Euroklav S+/ VS+

Last Log Autom. Feed water Water system


3
Total batches Date / time 2
batch number: output preheating inflow

S P S P S P S P S P S P S P

Last batch number Total batches Date / time P 1 P


Output medium: No Internal One-way
xx xx Hour: xx S + S +
- -
P P
Yes External Circulation
Date / time Immediate output
= see S
Minute: xx Yes/No
above P P P
P
Date / time
= see Output P
Second: xx
+ above last cycle: No. xx S + -
- Date / time - +
= see P
Day: xx
above Output
S
Date / time stored cycles
= see P + - Selector keys: “Next” (forwards/back) in the menu loop
Month: xx
above Occupied: xx P Program selection: “Enter/confirm/entry”
Date / time Free: xx
= see S Start/Stop key: “Abort/escape/leave”
Year: xx
above Delete S Start/Stop key: “Escape/leave” without saving
S
+ - all cycles
P Page forwards through the main and submenu loop
Test output with the ‘+’ key and backwards with the ‘−’ key. The
S
‘S’ key enables you to leave the menu at any time.
P
+ -
4 Description of the device

4 Description of the device

Scope of delivery
Please check the scope of delivery before setting up and connecting the device.

Standard scope of delivery


▪ Euroklav 23 VS+ or Euroklav 29 VS+
▪ User manual
▪ User manual Accessories for small steam sterilizers
▪ Technical Manual
▪ Warranty certificate
▪ Manufacturer’s inspection report including declaration of conformity
▪ Record of installation and setup
▪ Mount for trays or sterilization containers
▪ Hose for emptying the interior storage tank
▪ Key for the “vacuum / flow” chamber filter
▪ Lever for emergency release of the door
▪ 2x replacement device fuses on the inside of the steam sterilizer door
▪ Tray lifter

13
4 Description of the device

Views of the device


Front

1 Tank lid
4 2 Operating and display panel
3 Door, swings open to the left
4 Slide locking grip
5 Power switch
6 Front device foot (adjustable)

Rear panel

7 Spring safety valve


7
8 Sterile filter
9 One-way outlet
8 10 Feed water inflow via the internal
storage tank
9
11 Hose bridge for internal feed
10 water supply

11 12 Power cable

12

14
4 Description of the device

View of the interior

13 Fixing for MELAdem 40


14 Sterilization chamber
13
15 Door locking pin
14 16 Chamber seal face
17 2 device fuses
15
18 Overheat protection reset button
16 19 Serial data and printer connection
(RS232)*)
20 Connection for emptying the
storage tank - feed water
21 Connection for emptying the
storage tank wastewater
23 22 21 20 19 18 17 22 Door gasket
23 Round blank
*) Concealed by the cover

Symbols on the device


Type plate

Manufacturer of the product

Date of manufacture of the product

MD Label as medical device

Observe user manual or electronic user manual

Do not dispose of product in household waste

CE marking

0035 Identification number of the notified body responsible for conformity assessment accord-
ing to Pressure Equipment Directive 2014/68/EU

0197 Identification number of the notified body responsible for conformity assessment accord-
ing to Regulation (EU) 2017/745 on medical devices

Volume of the sterilization chamber

Working overpressure in sterilization chamber

Operating temperature in sterilization chamber

15
4 Description of the device

Electrical connection of the product: Alternating current (AC)

Front of the device

Bleed valves, internal storage tanks:


1 = Wastewater side 2 = Feed water side

Reset button for the overheat protection of the capillary tube controller

Symbols on the power switch


Switching on device

Switching off device

Operating panel
The operating panel consists of a two-row alphanumerical LC display and four membrane keys.

1 2 3

14:27:12
0,02bar 25 °C

4 5 6

1 2-row LC display
for displaying the program status and parameters
2 Time (h:min:s)
3 Chamber pressure (bar) and (steam) temperature (°C)
4 Function keys '-' and '+'
for the selection, setting and display of special functions: print, date/time, preheating, total batches,
conductivity, acknowledge malfunction, key '+' for unlocking the door
5 Program selection key 'P'
for selecting the sterilization program / test program and selection / setting of the options (submen-
us) of the special functions
6 Start – Stop key 'S'
for starting programs, aborting programs / drying and controlling the special functions

Initial state
Each time the device is switched on, the display changes to the initial state, showing the current time, the
chamber pressure in bar and the (steam) temperature in °C.

16
4 Description of the device

Load mounts
For detailed information about the different mounts, how to combine them with different load holders and
how to use them, please refer to the separate document “User manual Accessories for small steam
sterilizers”.

Mount A Plus
The mount (A Plus) is standard and can accommo-
date either five trays or up to three sterilization con-
tainers when turned 90°.

Mount D
The mount (D) can accommodate two tall steriliza-
tion containers (e.g. 28M) or four trays (when turned
90°).

17
5 First steps

5 First steps

Setup and installation

PLEASE NOTE
For setup and installation, observe the information in the technical manual. This contains
all building-side requirements.

Record of installation and setup


The record of installation is to be completed by the responsible stockist and a copy sent to MELAG as
proof of the correct setup, installation and initial commissioning. This is a constituent part of any guarantee
claim.

Feed water supply


Steam sterilization requires the use of distilled or demineralised water, known as feed water. Annex C of
EN 13060 specifies the guideline values to be observed.
The feed water supply is effected either via the internal storage tank or via a separate water treatment unit
(e.g. MELAdem 40/MELAdem 47). When using the internal storage tank for the feed water supply, it is
necessary to refill it. The steam sterilizer will issue notification at the relevant time. The used feed water, so
called wastewater is either collected in the internal storage tank on the wastewater side (left) and emptied
manually or disposed of automatically via a building-side wastewater connection.
A water treatment unit is connected to the domestic water supply. It produces the feed water which the
steam sterilizer requires for steam generation. The use of a water treatment unit guarantees the availability
of sufficient feed water. You no longer have to manually fill the internal water storage tank.

PLEASE NOTE
Should you wish to use a water treatment unit from another manufacturer, please consult
MELAG.

Using the internal water storage tank


When feed water is supplied via the internal storage tank, this needs to be filled manually from time to
time. The steam sterilizer will issue notification at the relevant time.
The internal storage tank holds max. 4 l. This volume of feed water is sufficient for up to 7 sterilization
runs.
The steam-generating system requires at least 1 l to ensure the feed water supply.
Ensure the following when filling:
u No feed water should be added to the internal storage tank during operation, as steam vapours may
escape from the tank during operation.
u During operation, the surfaces on the tank (e.g. lid) may be hot.
u To fill the storage tank with fresh feed water remove the cover and fill the right-hand chamber of the
storage tank (right) with fresh feed water up to the MAX mark.

18
5 First steps

Setting the feed water supply on the steam sterilizer


The internal function must be set in order to enable feed water supply via the internal storage tank. The
external function must be set in order to enable feed water supply via a water treatment unit.
1. Select the SETUP menu Function by pressing the '+' and '-' keys simultaneously. The display will
show the notification Function: Last batch number.
2. Navigate using the '+' or '-' key until the display shows: Function: Feed water supply.
3. Press the 'P' key. The display shows the option currently set.
4. Press the 'P' key again to change to the desired setting (internal/external).
5. Press the 'S' key to save the setting and to leave the menu.
Repeated pressing of the 'S' key enables you to leave the menu entirely and return to the display basic
state.

Wastewater connection
The wastewater can either be collected in the internal storage tank on the wastewater side (left) and be
removed manually or be let out automatically via the one-way outlet. An upgrade kit can be ordered to
connect the steam sterilizer to the wastewater. Detailed information regarding the connection to the
wastewater is provided in the technical manual.

Switching on the steam sterilizer


ü The steam sterilizer is connected to the electricity supply.
} Switch on the device at the power switch.
The display switches between the initial state and the notification Unlock door with '+' key, as long
as the door is closed.

PLEASE NOTE
The trays and all accessories must be removed from the sterilization chamber directly
after the steam sterilizer having been switched on for the first time and before initial
commissioning.

After device activation, a heating up time of approx. 5 min (Euroklav 23 VS+) or approx. 3 min
(Euroklav 29 VS+) is required. A program will be started only after the target temperature has been
reached.

PLEASE NOTE
When switching off the device via the power switch, wait 3 s before switching it back on.

Opening and closing the door


The door can only be opened when the display shows Acknow. with '+' key / Unlock door with
'+' key.
1. Press the '+' key. You can open the door after hearing an audible click.
2. To shut the door, press it lightly against the device and slide the slide locking grip downwards to its at
the same time.

19
5 First steps

Setting the date and time


Correct batch documentation requires the correct date and time setting on the steam sterilizer. Ensure that
you take into account any clock change, as this is not adjusted automatically. Set the date and time as
follows:
1. Select the Function menu by pressing the '+' and '-' keys simultaneously.
Ê The display will show the message Function: Last batch number.
2. Navigate in the Function menu using the '+' or '-' keys until the display shows:

Function
Date / time

3. Press the 'P' key to confirm.


Ê The current hour is displayed.
4. Choose one of the following setting possibilities using the '+' or '-' key: Hour, minute, second, day,
month, year.
5. To e.g. adjust the hours parameter, press the 'P' key to confirm.
Ê The current value flashes on the display.
6. You can increase or reduce the value using the '+' and '-' keys.
7. Confirm with the 'P' key in order to save the value.
Ê The current value set no longer flashes on the display.
8. Proceed in a similar fashion to alter the other parameters.
9. After completing the settings, press the 'S' key to leave the menu.
Ê The display will show Function: Date / Time.
10. Repeated pressing of the 'S' key enables you to leave the menu and the display returns to its initial
state.

20
6 Sterilization

6 Sterilization

Preparing the load


Always clean and disinfect properly before sterilization. Only in this way is it possible to guarantee the
subsequent sterilization of the load. The materials used, cleaning agents and reprocessing procedure are
of decisive significance.
Comply with the following for safe handling:

NOTICE
Only ever operate the steam sterilizer with a sterile filter inserted.

Reprocessing textiles

WARNING
The incorrect reprocessing of textiles, e.g. a textile package can prevent steam
penetration or produce poor drying results.
The textiles could not be sterilized.

Comply with the following points when reprocessing textiles and placing the textiles in sterile containers:

Without sterilization container


u Comply with both the reprocessing instructions of the textile manufacturer the relevant standards,
guidelines and directives (in Germany e.g. of the RKI and DGSV).
u Arrange the folds in the textiles parallel to each other.
u Fold the textiles in such a way that permits use of the entire tray.

With sterilization container


u Stack textiles vertically wherever possible and not too closely together in the sterile container. This
enables the development of flow channels.
u If textile packages do not remain together, wrap the textiles in sterilization paper.
u Only ever sterilize dry textiles.
u The textiles may not be permitted to come into direct contact with the sterilization chamber; otherwise
they will become saturated with condensate.

Reprocessing instruments
Unwrapped sterile material loses its sterility on contact with ambient air. If you intend to store your
instruments sterilely, wrap them in suitable packaging before sterilization.
When reprocessing used and brand-new instruments, comply with the following:
u Always observe both the instrument manufacturer’s reprocessing instructions and the relevant
standards, guidelines and directives (in Germany, for example, from RKI, DGSV and DGUV
Regulation 1).
u Clean the instruments exceptionally thoroughly e.g. using an ultrasonic device or washer-disinfector.
u Rinse the instruments after washing and disinfecting, where possible with demineralised or distilled
water and then dry the instruments thoroughly with a clean, non-fuzzing cloth.
u Use only those care agents suitable for steam sterilization. Consult the manufacturer of the care
agents. Do not use any water repellent agents or oils impermeable to steam.

21
6 Sterilization

u When using ultrasound devices, care equipment for handpieces and washer-disinfectors, comply with
the manufacturer’s reprocessing instructions.

NOTICE
The presence of residual disinfection and cleaning fluids results in corrosion.
This could result in increased maintenance requirements and a restriction of the steam
sterilizer function.

Loading the steam sterilizer


Effective sterilization and good drying is only possible if the steam sterilizer has been loaded correctly.
Ensure the following during loading:
u Insert trays or sterile containers in the sterilization chamber only with their appropriate mount.

a
b
a a Tray
b
b b Sterile container

u Wherever possible, ensure the separate sterilization of textiles and


instruments in separate sterile containers or sterilization packages.
This leads to better drying results.

u The use of paper tray inserts can result in poor drying results.
u Use perforated trays such as those from MELAG. Only in this way can
condensate drain off. Non-perforated bases or half-shells for holding
the load lead to poor drying results.

Packaging
Only ever use packaging materials and systems (sterile barrier systems) which fulfil the standard
EN ISO 11607-1. The correct use of suitable packaging is important in achieving successful sterilization
results. You can use re-usable rigid packaging systems or soft packaging such as transparent sterilization
package, paper pouches, sterilization paper, textiles or fleece.

Closed sterile containers

WARNING
Risk of contamination due to insufficient steam penetration or poor drying.
n Use only suitable sterile containers.
n Do not cover the perforations when stacking the sterile containers so that the condensate
can drain off.

Please comply with the following when using closed sterile containers:
u Use aluminium sterilization containers. Aluminium retains and conducts heat and thus accelerates
drying.
u Wherever possible, please ensure that sterilization containers are only stacked on top of those with
identical base dimensions, so that the condensate can run down their sides.
u Ensure that the perforations are not covered when stacking the containers.
Tip: MELAG sterile containers fulfil the requirements of EN 868-8 for successful sterilization and drying.
They have a perforated lid and base and are fitted with disposable paper filters.

22
6 Sterilization

Soft sterilization packaging


Soft sterilization packages can be used in both sterile containers and on trays. Please comply with the
following when using soft sterilization packages e.g. MELAfol:
u Arrange soft sterilization packaging in a perpendicular position and at narrow intervals.
u Place transparent sterilization packages on their edge wherever possible and with the paper side
facing downwards.
u Do not place multiple soft sterilization packages flat on top of each other on a tray or in a container.
u If the seal seam tears during sterilization, the packaging could be too small or the sealing pulse too
low. Re-pack the instruments and if necessary, extend the sealing pulse on the film sealing device or
make a double seam. Sterilize the sterilization material again.

Multiple wrapping
The device uses a fractionated flow procedure. This permits the use of multiple wrapping when sterilizing
textiles.

Mixed loads
Please observe the following when sterilizing mixed loads:
u Always place textiles at the top
u Sterile containers at the bottom
u Place unwrapped instruments at the bottom
u Place the heaviest loads at the bottom
u Transparent sterilization packages and paper packages on the top. Exception: At the bottom in
combination with textiles

c
a
a Packages
a
b Heavy loads/instruments
c Textiles
b b

23
6 Sterilization

Loading versions
Example:

Loading versions*) Euroklav 23 VS+ Euroklav 29 VS+


Instruments / textiles Instruments / textiles
)
Max. weight per component 2 kg / 1 kg (0.8 kg** ) 2 kg / 0.8 kg
Maximum total weight***) 4 kg / 1 kg (0.8 kg**)) 3 kg / 0.8 kg
)
* For MELAG mounts, trays, sterilization containers, see Accessories and spare parts [} Page 60]
**) In the Gentle-Program.
***) This applies solid loads (e.g. instruments) including the weights of mounts, trays and sterilization con-
tainers. This applies porous loads (e.g. textiles) excluding the weights of mounts, trays and sterilization
containers.
Loading patterns can be found in the separate document "User manual Accessories for small steam
sterilizers".

Selecting the program


Select by rotating between the initial state and the desired program with the program selection button 'P'.
Now select the sterilization program according to how and whether the sterilization material is wrapped. It
is also necessary to take into account the temperature resistance of the sterilization material.
The following table shows which program is to be selected for which sterilization material.

Universal- Quick- Gentle- Prion-


Program Program S Program Program
Sterilization temperature 134 °C 134 °C 121 °C 134 °C
Sterilization pressure 2.1 bar 2.1 bar 1.1 bar 2.1 bar
Sterilization time 5:30 min 3:30 min 20:30 min 20:30 min
Operating time 22-25 min 12:30-17 min 38-41 min 38-41 min
Euroklav 23 VS+*)
Operating time 20-24 min 11:30-14:30 min 34-36 min 34-39 min
Euroklav 29 VS+*)
Drying approx. 25 min approx. 10 min approx. 25 min approx. 25 min
*) without drying, depending on the load (full load Euroklav 23 VS+: 4 kg / Euroklav 29 VS+: 3 kg) and in-
stallation conditions (such as supply voltage)

Overview of the use of the respective sterilization programs

Program name Packaging Especially suitable for Load*)


23 VS+ 29 VS+
Universal-Program Wrapped Mixed loads; transmission in- 4 kg 3 kg
struments, simple hollow
bodies
Quick-Program S Only unwrapped Single massive instruments; 4 kg 3 kg
(no textiles) simple hollow bodies
Gentle-Program Wrapped Textiles; thermo-unstable Textiles Textiles
items (e.g. plastic, rubber ar- 0.8 kg 0.8 kg
ticles) Thermo-unsta- Thermo-unsta-
ble equipment ble equipment
Good Good
4 kg 3 kg

24
6 Sterilization

Program name Packaging Especially suitable for Load*)


23 VS+ 29 VS+
Prion-Program Wrapped Instruments that may come 4 kg 3 kg
into contact with prion risk
tissue and where cleaning
was no performed in an ex-
plicit prion decontamination
procedure (e.g. Creutzfeldt-
Jakob).**)
*) This applies solid loads (e.g. instruments) including the weights of mounts, trays and sterilization con-
tainers. This applies porous loads (e.g. textiles) excluding the weights of mounts, trays and sterilization
containers.
**) Comply with all relevant national specifications (e.g. in Germany, Appendix 7 Chapter 1.3.1 RKI guide-
lines).

Additional program options

Selecting automatic preheating


Automatic preheating is activated in delivery state.
If preheating is activated, the cold chamber is heated up to the preheating temperature of the particular
program before program start, or this temperature is held between two program runs. This reduces
program times and the accretion of condensation, thus improving drying results.

PLEASE NOTE
The steam sterilizer must remain continually activated for the automatic preheating.
MELAG recommends activating the automatic preheating function.

To alter this setting proceed as follows:


1. Select the Function menu by pressing the '+' and '-' keys simultaneously until the display
shows Function: Last batch number.
2. Navigate using the '+' or '-' key until the display shows:

Function:
autom. preheating

3. Press the 'P' key to confirm.


Ê The display will show the option currently set e.g. Preheating YES.
4. Pressing the 'P' key again makes the display switch to Preheating NO.
Ê The preheating function has been deactivated.
5. Press the 'S' key twice to leave Function: Autom. preheating and return to the initial state.

25
6 Sterilization

Selecting additional drying


The Additional drying function extends the drying time by 50 % to perform difficult drying tasks.
} Press the 'S' and '+' keys simultaneously upon program start.
The display will show:

Additional drying
selected

The program run will now begin.

Starting the program

NOTICE
Unsupervised operation of electrical devices, including this steam sterilizer at the
operator’s risk. MELAG accepts no liability what so ever for any damage resulting from
unsupervised operation.

After having selected a program via the program selection key 'P', the display will show both the selected
program and sterilization temperature as well as whether the program is suitable for wrapped or
unwrapped loads.

Universal-Program
134 °C wrapped

} Press the 'S' key to start the program.


The steam sterilizer checks the feed water supply and its conductivity.

PLEASE NOTE
When the Quick-Program S is started, the warning message Attention: Unwrapped
instruments only appears on the display.
If the load contains exclusively unwrapped instruments, press the 'S' key again to
confirm and to start the program.

Program run
After starting the program, you can follow the program run in the display. It shows the chamber
temperature and pressure as well as the time until the end of sterilization or the drying time which has
passed.

1. Fractionation
-0.085 bar 22 °C

26
6 Sterilization

Sterilization phase
The display enables you to see whether the sterilization phase has already been completed successfully.
The time left in the sterilization phase is shown in the display in alternation with the pressure and
temperature.

Sterilization
2 min, 12 s

Drying phase
The regular drying time is variable for the Quick-Program S approx. 10 min and for all other programs
approx. 25 min. The display will show the corresponding message during the drying phase.

Vacuum drying
since 2' -0.12 bar 60 °C

The steam sterilizer provides excellent drying of the sterile material. If difficult-to-dry items require better
drying, you can undertake the following steps to improve drying:
u Load the steam sterilizer properly. Stand e.g. the transparent and paper sterilization packaging
upright, see Loading the steam sterilizer [} Page 22]. Use the optional package holder if necessary.
u Activate the function Additional drying, see Selecting additional drying [} Page 26].

Program end
When the program has been completed successfully, the display shows:

Universal-Program
run successfully

If immediate output after program end is activated in SETUP menu Function > Last batch number,
then the log of the completed program is output to the activated output media after the door is opened, see
Logging [} Page 30].

Manual program abort


You can abort a current program in all phases. If you abort the program before the end of the sterilization
phase, the load is not sterile.

WARNING
Hot steam can be released from the device when opening the door after a program abort.
This could result in scalding.
n Use a tray lifter to remove the tray.
n Never touch the sterile material, the sterilization chamber or the door with unprotected
hands. The components are hot.

NOTICE
Aborting a running program by switching off the power switch can result in the egress of
hot steam from the sterile filter and will cause the soiling of the sterile filter.
n Never abort a program by switching off at the mains.

27
6 Sterilization

Program abort before the start of drying

WARNING
Danger of contamination as a result of premature program abort
Aborting a program before the drying phase begins means that the load is unsterile.
n Re-pack the load if necessary.
n Repeat the sterilization of the load.

Proceed as follows to abort the program before drying:


1. Press the 'S' key.
2. Confirm the following security query Stop program? by pressing the 'S' key repeatedly.

PLEASE NOTE
The security query will be displayed for approx. 5 s. If the 'S' key is not pressed again,
the program will continue with the usual program run.

Depending on the time of the abort, pressure will be released or the device will be ventilated. A
corresponding display text appears on the display.
After pressure release or ventilation, you will be asked to acknowledge the program abort.
The display will alternate between Stop / End and Acknowledge with '-' key.
3. Press the '-' key.
Ê The display will alternate between Unlock door with '+' key and the program previously
selected.
4. You can open the door after pressing the '+' key.
Ê The log will contain: Program stopped / Load not sterile!

Program abort after the start of drying


You can abort the program during the drying phase via the 'S' key without the steam sterilizer registering a
malfunction.
Should you abort a program after drying has started, the sterilization is having been completed
successfully. The steam sterilizer will not issue a malfunction message. You should expect insufficient
drying, especially in the case of wrapped sterile material and a full load. Sterile storage requires sufficient
drying. To ensure this, allow programs with wrapped sterile material to continue to the end of the drying
phase as far as possible. Unwrapped instruments sterilized in a Quick-Program dry after being removed
from their own warmth.
The drying time completed thus far is indicated on the display during the drying phase. This will alternate
with the display of:

Immediate removal
press 'Stop'

Proceed as follows to abort the program during drying:


1. Press the 'S' key.

PLEASE NOTE
The security query will be displayed for approx. 5 s. If the 'S' key is not pressed
repeatedly, the program will continue with the usual program run.

28
6 Sterilization

2. Confirm the following security query Immediate removal 'Stop' by pressing the 'S' key again.
Ê The display confirms the abort with Drying stopped.
After ventilation of the chamber, the display will show: Universal-Program run successfully in
alternation with:

Last batch no. 46


Quit with button '+'

If a printer or other output medium is connected to the steam sterilizer, and Immediate output is set
to YES, the notification Drying stopped is recorded on the log.

Removing the sterile material

CAUTION
Danger of burns from hot metal surfaces
n Allow the device to cool sufficiently before opening.
n Do not touch any hot metal parts.

CAUTION
Unsterile instruments resulting from damaged or burst packaging. This endangers the
health of your patients and practice team.
n Should the packaging be damaged or have burst after sterilization, wrap the load again and
re-sterilize it.

If you remove the sterile material from the device directly after the end of the program, it is possible that
the instruments can be partially damp. According to the red brochure of the Arbeitskreis für
Instrumentenaufbereitung (AKI), single drops of water (no puddles) that dry off within 15 min are
considered tolerable residual moisture in practice.
Comply with the following specifications when removing the sterile material:
u Never use force to open the door. This could damage the device or result in the emission of hot
steam.
u Use a tray lifter to remove the tray.
u Never touch the sterile material, the sterilization chamber, the mount or the inside of the door with
bare hands. The components are hot.
u Check the packaging of the sterile material for damage when removing it from the device. Should the
packaging be damaged, re-pack the load and re-sterilize it.

Storing sterile material


The maximum storage time is dependent on the packaging and the storage conditions. Please observe the
regulatory requirements for the storage period of sterile materials (in Germany e.g. DIN 58953, Part 8 or
the DGSV guidelines) as well as the following listed criteria:
u Comply with the maximum storage duration in accordance with the packaging type. Comply with the
manufacturer’s information on the packaging.
u Store the sterile material in a dust-protected environment e.g. in a closed instrument cabinet.
u Store the sterile material in an environment protected against moisture.
u Store the sterile material in an environment protected against excess temperature variations.

29
7 Logging

7 Logging

Batch documentation
The batch documentation serves as proof of the successful conclusion of the program and represents an
obligatory part of quality assurance. The device internal log memory saves such data as the program type,
batch and process parameters of all the programs completed.
To obtain the batch documentation, you can output the internal log memory and transfer its data to various
output media. This can be performed immediately at the end of every program or at a later point, such as
at the end of the day.

Capacity of the internal log memory


The capacity of the internal log memory is sufficient for 40 logs. If the internal log memory is full, the oldest
log will be overwritten automatically at the beginning of the next program.
If a printer is connected and the option Immediate output has been set to NO, a security query will be
issued before the saved log is overwritten. For further information about connecting the printer, consult the
user manual of the respective device.

Displaying the daily batch counter


The last batch number of the day is shown on the display after every program run.

Last batch no.


10

You can also arrange for the batch number to be displayed. To do so:
1. Select SETUP menu Function by pressing the '+' and '-' keys simultaneously. The display will show
the notification Function: Last batch number.
2. Press the 'P' key to display the current daily batch number.
3. To return to the basic state, press the 'S' key twice.

Displaying the total batch counter


You can arrange the display of the number of the batches previously run:
1. Select SETUP menu Function by pressing the '+' and '-' keys simultaneously. The display will show
the notification Function: Last batch number.
2. Navigate using the '+' or '-' keys until the display shows:

Total batch
22

3. Press the 'P' key to display the current total batches counter.
4. To return to the basic state, press the 'S' key twice.

30
7 Logging

Output media
You are able to output and archive the logs of the completed programs on the following output media:
▪ MELAflash CF card printer on the CF card
▪ Computer, e.g. with MELAtrace software (optionally with MELAnet Box)
▪ MELAprint 42/44 log printer
▪ MELAprint 80 universal printer
In its delivery state, an option for log output is not set on the steam sterilizer.

PLEASE NOTE
Further information about the printer (e.g. the duration of the readability of the log
printouts) is specified in the associated user manual.

Using a computer as an output medium (without a network connection)


In order to be able to use a computer as an output medium, the computer must be connected to the steam
sterilizer via the serial interface.
You can connect the steam sterilizer to a computer if the following conditions are fulfilled:
ü The computer is either fitted with a serial interface or a USB serial adapter is connected.
ü The documentation software MELAtrace is installed on the computer.

PLEASE NOTE
The MELAnet Box is required for integration in the (practice) network.

1. Open the door of the steam sterilizer.


2. Open the white cover of the serial data and printer connection on the steam sterilizer: To do this, use
a coin to turn the locking slot (pos. a) on the white cover a quarter of a turn.
3. Remove the cover.
4. Push the metal frame (pos. d) downwards slightly until it unlocks and then fold the metal frame
forwards.
5. Push the metal frame (pos. d) downwards slightly until it snaps into place and can no longer fold back
independently.
6. Connect the steam sterilizer to the RS232 interface (pos. c) to the computer with a fitting data
connection cable.

PLEASE NOTE
If the computer is constantly connected to the steam sterilizer, you can insert the serial
cable in the cable guide (pos. b), fold in the metal strap and replace the cover.

a b c d

31
7 Logging

Reading out text logs on the computer


You can use the MELAtrace software to read out the logs.
The following settings are required to register the computer on the steam sterilizer:
1. Switch on the steam sterilizer.
Wait until the display shows the initial state.
2. Select SETUP menu Function by pressing the ‘+’ and ‘−’ keys simultaneously. The display will
show the notification Function: Last batch number
3. Navigate with the ‘+’ or ‘−’ key in the Function menu until the display shows Function: Log
output.
4. Press the ‘P’ key to select the Log output – Output medium sub-menu.
5. Press the ‘P’ key again. If an output medium has yet to be chosen, the display will show the Log
output - No output medium notification.
Navigate using the ‘+’ or ‘−’ key until the display shows:

Output medium
Computer

6. Press the ‘P’ key to confirm. The display switches back to the Log output – Output medium
menu.
7. Press the ‘S’ key to return to the SETUP menu Function: Log output menu.
8. After repeated pressing of the ‘S’ key, the display returns to its initial state.

Opening text logs on the computer


All text logs can be opened and printed using a text editor, a word processing program or a spreadsheet
program.

PLEASE NOTE
Graphic logs can only be displayed with the MELAtrace documentation software.

Each text log (e.g. .PRO, .STR, .STB) must be linked with the text editor to enable the operating system of
your computer to open them automatically with a text editor. The meanings of the endings are outlined in
the section Subsequent log output [} Page 34]. The following examples show how you can link the
Windows 10 editor with a specific text log.
1. In Windows Explorer double click on the log file.

2. If the file ending is unfamiliar, Windows 10 will display


the following message:

3. Select “Try an app on this PC”.

32
7 Logging

4. Mark the editor and confirm with “OK”.

Ê You can then open files with this ending via a double-click in Windows Editor.
Alternatively, you can open all text logs with the documentation software MELAtrace.

Outputting logs immediately and automatically


Text logs
If you want to output the associated text log automatically after the end of a program on an output medium,
use the function Immediate output YES. This is not set in the delivery state.
The following requirements must be fulfilled in order to issue logs immediately after the end of a program:
ü In the menu Function: Log output, immediate output is set to YES.
ü At least one output medium must be selected (computer, e.g. log printer MELAprint 42/44).
ü The activated output medium must be connected and initialised.
1. Switch on the steam sterilizer at the power switch.
2. Select the Function menu by pressing the '+' and '-' keys simultaneously.
The display will show the message Function: Last batch number
3. Navigate using the '+' or '-' key until the display shows: Function: Log output and press the ‘P’
key.
4. Navigate using the '+' or '-' key until the display shows:

Immediate output
YES

5. Press the 'P' key to change between Immediate output NO / YES.


6. Press the 'S' key to save the setting and to leave the menu. The display will show Function: Log
output.
7. Pressing the 'S' key once again enables you to leave the menu and return to the display initial state.

PLEASE NOTE
If immediate output is unable to issue a log, for example, because the output medium
activated is not connected, a warning message will appear. MELAG recommends using
the immediate log output function.

33
7 Logging

Graphic logs
For log output immediately after program end, comply with the following:
u In Function: Log output, MELAnet+graphic data must be selected as the output medium.
u The computer or another medium must be connected and initialised.

Subsequent log output


It is possible to issue logs subsequently and independently of the time of a program end. You can choose
whether selected or all saved logs (up to 40) are to be output. Use the output medium connected for this
task e.g. the log printer.

Printing selected logs


To print the subsequently selected logs of a particular program proceed as follows:
1. Select the menu Function by pressing the '+' and '-' keys simultaneously. The display will show the
message Function: Last batch number.
2. Navigate using the '+' or '-' key until the display shows: Function: Log output and press the 'P'
key.
The Log output – Output medium menu will be displayed.
3. Navigate using the '+' or '-' key until the display shows: Last cycle output: no. 40 (as example
no. 40).
4. Press the 'P' key. The current log number flashes.
5. To output a log or another cycle, navigate to the desired number using the '+' or '-' keys until you have
reached the desired number, e.g. 25.
6. Press the 'P' key in order to start the output of the selected program. The display will show the
message Output.
After a successful output, the display returns to its previous setting and shows:

Last cycle
output: 25

Repeat the last three steps in order to issue further logs.


7. Press the 'S' key to leave the submenu without outputting the log.
8. Press the 'S' key to leave the menu after outputting the log. The display will show the message
Function: Log output.
9. Repeated pressing of the 'S' key enables you to leave the menu entirely and return to the display
initial state.

34
7 Logging

Outputting all saved logs


Proceed as follows to output all the saved logs subsequently:
1. Select the menu Function by pressing the '+' and '-' keys simultaneously.
The display will show the message Function: Last batch number.
2. Navigate using the '+' or '-' key until the display shows Function: Log output and press the 'P'
key.
3. Navigate using the '+' or '-' key until the display shows:

Output
stored cycles

4. Press the 'P' key in order to start the output of the selected program. During the output the message
Output will be displayed.
Ê If output has been performed, the display will show: Output stored cycles.
5. Press the 'S' key to leave the submenu without outputting the log.

PLEASE NOTE
An abort during log output on the log printer is only possible through deactivation of the
device using the power switch or by interrupting the power supply to the printer.
When switching off the device via the power switch, wait 3 s before switching it back on.

6. Press the 'S' key to leave the menu. The display will show the message Function: Log output.
7. Repeated pressing of the 'S' key enables you to leave the menu entirely and return to the display
initial state.

Displaying the log memory


If a printer or other output medium is connected and initialised, you can check how many logs have
already been saved in the steam sterilizer log memory.
Proceed as follows:
1. Select the Function menu by pressing the '+' and '-' keys simultaneously. The display will show the
message Function: Last batch number.
2. Navigate using the '+' or '-' key until the display shows Function: Log output and press the 'P'
key.
3. Navigate using the '+' or '-' key until the display shows the number of logs saved.

Allocated: 26
Free: 14

4. Press the 'S' key twice to leave the menu.

35
7 Logging

Deleting logs in the internal log memory


Delete the saved logs manually to suppress warnings, e.g. Log memory full, while the option
Immediate output is set to NO. The following example shows how to delete all the logs saved.
1. Select the Function menu by pressing the '+' and '-' keys simultaneously. The display will show the
message Function: Last batch number.
2. Navigate using the '+' or '-' key until the display shows Function: Log output and press the 'P'
key.
3. Navigate using the '+' or '-' key until the display shows:

Delete
all cycles

4. Press the 'P' key to delete all logs.


5. To cancel the sub-menu without deleting, press the 'S' key.
6. Press the 'P' key to leave the menu after deletion. The display will show the message Function:
Log output.
7. Repeated pressing of the 'S' key enables you to leave the menu entirely and return to the display
initial state.

Reading logs correctly


Log type File ending Explanation
Text log .PRO Log of a completed program
Malfunction log .STR Log of an unsuccessfully finished program
Graphic log .GPD Program run displayed as a graphic curve
Standby log .STB Log for malfunctions in idle mode
Demo log .DEM Log of a simulated program run.
No real sterilization will be performed!
Demo graphic log .DEG Simulated program run displayed as a graphic curve. No real
sterilization will be performed!

Log header
The header of the program log comprises the general basic information regarding the program run. This
includes e.g. date, the selected program, the daily batch number and the device type.

Program step values


The phases of the program run are recorded whilst it runs and the values for steam pressure, temperature
and time (related to the program start) are recorded.

Summary
The summary states whether the program has been completed successfully. The values of the sterilization
time required, the sterilization temperature and the pressure (including the maximum deviation) are also
displayed.

36
7 Logging

Example for a text log of a successfully completed program

Steam sterilizer type


----------
Started program
Current date
Time at program start
Daily batch number
Serial number

Pre-heating temperature
Feed water conductivity

PROGRAM STEP VALUES

Program run phases with the appendant values for


pressure, temperature and time (relative to the program
start)

SUMMARY
Control message
Median sterilization temperature with max. deviations
Median sterilization pressure with max. deviations
Sterilization time maintained
Time upon program end

Information with total batch counter, factory number and


device software version number

37
8 Function checks

8 Function checks

Automatic functional checks


The electronic parameter control subjects the interaction of the sterilization-relevant parameters pressure,
temperature and time to constant automatic monitoring. The steam sterilizer process evaluation system
compares the process parameters during the program with each other and monitors them in terms of their
threshold values. The steam sterilizer monitoring system checks the device components for their
functionality and their plausible interaction. Should the parameters exceed pre-set threshold values, the
steam sterilizer emits warning or malfunction messages. If necessary, it interrupts the program with
appropriate information. When the program has ended successfully, the corresponding message will be
shown on the display.

Manual functional checks


You can follow the program run on the display via the values displayed there. You can also use the log
recorded for every program to determine its success, see Logging [} Page 30].

Vacuum test
The test detects leaks in the steam sterilizer. This determines the leakage rate at the same time.
Perform a vacuum test in the following circumstances:
▪ Once a week in routine operation
▪ During commissioning
▪ Following longer operating pauses
▪ In the case of a corresponding malfunction (e.g. in the vacuum system)
Perform the vacuum test with the steam sterilizer in a cold and dry state as follows:
1. Switch on the device at the power switch. The display switches to its initial state.
2. Press the 'P' key until the display shows Vacuum test.
3. Close the door.
4. Press the 'S' key to start the vacuum test.
Ê The evacuation pressure and the equilibration time or measurement time are shown on the display. The
sterilization chamber is ventilated after the end of the measuring time. Then the message will be shown
on the display with an indication of the leakage rate. Should the leakage rate be too high i.e. over 1.3
mbar, a corresponding message will appear on the display.
The current daily batch number and Acknow. with '+' key is displayed. You can open the door after
pressing the '+' key.

PLEASE NOTE
If a log printer or another output medium is connected and the setting Immediate
output YES is set, a log printout will be issued at the same time.

38
8 Function checks

Bowie & Dick test


The Bowie & Dick test serves as proof of steam penetration of porous materials such as e.g. textiles.
Specialist stockists provide various test systems for the Bowie & Dick test. Perform the test according to
the test system manufacturer information.

Bowie & Dick test


134°C 2.2 bar 3.5'

How to start the Bowie & Dick test program:


1. Switch on the device at the power switch.
2. Select the Bowie & Dick test by pressing the 'P' key repeatedly.
3. Press the 'S' key to start the Bowie & Dick test.
Following a successful test program, the current batch number of the day is displayed, alternating with
Acknow. with '+' key. You can open the door after pressing the '+' key.

PLEASE NOTE
If a log printer or another output medium is connected and the setting Immediate
output YES is set, a log printout will be issued at the same time.

Evaluation of the indicator following the colour change


Depending on the manufacturer batch, indicators often exhibit differing intensities in the colour change
resulting from different lengths of storage or other influences. Of crucial importance for evaluating the
Bowie & Dick test is not the strength of contrast in the colour change on the test sheet, but the uniformity
of the colour change on the indicator. If the indicator indicates an equal distribution of colour change, the
air removal of the sterilization chamber is without fault. If the indicators are uncoloured or exhibit less
colour in the centre in comparison to the end, air removal was insufficient. In this case, contact the
authorised technician.

Checking the quality of the feed water


You can access the water quality on the display at any time during a current program when the steam
sterilizer is switched on.

AIN6: Conductivity
15 µS/cm

} To do so, hold the '-' key depressed until the display shows Conductivity.
Ê The conductivity is displayed in µS/cm.
Ê As soon as you have released the '-' key, the display returns to its previous state (e.g. initial state).

Pre-heating temperature of the sterilization chamber


} Press the '-' key twice. When pressing the first time, press shortly. When pressing the second time,
hold the key depressed.

AIN4: Temp. preheat.


120°C

Ê The conductivity display disappears and the preheating temperature in the chamber will be
displayed.

39
9 Maintenance

9 Maintenance

Servicing intervals
Interval Measure Device components
Daily Check for soiling, deposits or chamber inc. door seal and chamber seal-
damage ing face, door lock, mount for the load
After 24 months or Maintenance By the authorized customer services work-
1000 cycles ing in accordance with the maintenance
instructions
As required Cleaning the surfaces Housing parts

Cleaning

NOTICE
Inappropriately performed cleaning can lead to the scratching of and damage to surfaces
and the development of leaks in sealing surfaces.
This also favours the development of soiling deposits and corrosion in the sterilization
chamber.
n Comply with all information regarding cleaning of the part affected.
n Do not use any hard objects for cleaning such as a metal saucepan cleaner or a steel brush.

Sterilization chamber, door seal, mount, trays


To maintain the value of your device and to prevent persistent contamination and deposits, MELAG
recommends weekly cleaning of the surfaces.
PLEASE NOTE: Also follow the additional application instructions for Chamber Protect or, if not available,
of the liquid cleaner or spirit.
The following must be fulfilled or present:
ü Chamber Protect (if not available: neutral liquid cleaner or spirits)
ü The door is open.
ü The device has been switched off.
ü The device has been completely cooled.
ü Trays or sterile containers and the associated mount have been removed from the sterilization
chamber.
1. Apply the cleaning agent on a lint-free cloth.
2. Use the lint-free cloth to spread the cleaning agent uniformly on the surfaces to be cleaned.
PLEASE NOTE: You should not allow cleaning fluid to enter the piping coming from the sterilization
chamber.
3. Allow the cleaning fluid to act and evaporate for a sufficient time. This may take a few minutes.
4. Wet a new lint-free cloth with plenty of demineralised water.
5. Wipe the cleaned surfaces thoroughly to remove cleaning residues. Repeat this process as necessary
after wringing out the cloth.
NOTICE! Residues of cleaning agents can ignite or cause deposits on the instruments.
6. Allow the cleaned surfaces to dry completely. This may take a few minutes.
7. Wipe the cleaned surfaces with a dry, lint-free microfibre cloth.

40
9 Maintenance

Housing parts
Where necessary, clean the housing parts with a neutral fluid cleaner or spirit.
Comply with the following specifications when disinfecting the housing parts:
u Use wipe disinfectants and not spray disinfectants. This prevents disinfectant from getting into
inaccessible places or ventilation slots.
u Only use alcohol-based surface disinfectants (ethanol or isopropanol) or alcohol-free disinfectants
based on quaternary ammonium compounds.
u Do not use disinfectants containing secondary and tertiary alkylamines or butanone.

Internal storage tank


Should you use the internal storage tank for the feed water supply, perform regular checks and cleaning.

Interval Measure
Each time you fill up Check the storage tank for soiling. If necessary, clean the storage tank be-
fore filling.
Weekly Replace the feed water completely.
Every 2 weeks Clean the drain side of the storage tank.

Empty the storage tank


1. Open the device door.

2. Connect the drain hose to the bleed valve for feed


water or wastewater. Turn the bleed valve with the
drain hose anti-clockwise as far as it will go.

3. Discharge the water into a container with min.


volume of 5 l.

4. Turn the bleed valve with the drain hose anti-


clockwise as far as it will go.
Ê The bleed valve is closed.
5. Remove the drain hose by pulling it lightly
backwards away from the device.

Clean the supply and wastewater side


ü The device has been completely cooled.
1. Remove the tank lid and the feed funnel.
2. Clean the feed water side (right) and wastewater side (left) with a lint-free cloth and fresh feed water.
3. Return the filling funnel and the tank lid.

41
9 Maintenance

Avoiding staining
Only proper cleaning of the instruments prior to sterilization enables you to avoid residue from being
released from the load under steam pressure during sterilization. Loosened dirt residue can clog the filter,
fittings and valves of the device and deposit themselves on the instruments and in the sterilization
chamber as deposits and stains.
All steam-conducting parts of the device consist of non-rusting material. This rules out the possibility of
stain or rust development being caused by the steam sterilizer. Any rust which develops is always
extraneous rust.
Incorrect instrument reprocessing can result in the accretion of rust even on stainless steel instruments of
leading manufacturers. Often, a single instrument which drops rust can suffice to cause the development
of rust on other instruments or in the device. Remove foreign rust from the instruments using chlorine-free
stainless steel cleaning fluid (see Cleaning [} Page 40]) or send the damaged instruments to the
manufacturer.
The extent of stain accretion on the instruments is also dependant on the feed water used for steam
generation.

Replacing the door seal


The door seal may not be greased or oiled. It should be kept clean and dry. If the door seal becomes worn
or looses form, it must be replaced. Otherwise, this could result in leaks which will enable steam egress, or
can cause too high a leakage rate in the vacuum test. The door seal is only inserted in the groove of the
round blank and can be changed as follows:

1. Open the steam sterilizer door and remove the old


door seal.

42
9 Maintenance

2. Insert the door seal in the groove of the round blank.

PLEASE NOTE
Make sure that the broad seal face faces the sterilization chamber when inserting. The
door can only be shut correctly and the sterilization chamber sealed, if the door seal sits
correctly in the groove.

Replacing or sterilizing the sterile filter


The sterile filter must be replaced regularly within the scope of the maintenance. In the event of
malfunctions and the fault message F32: Power failure/Sterilize sterile filter replace or
sterilize the sterile filter.

Replacing the sterile filter

1. Remove the sterile filter by turning and pulling it from


the holding sockets simultaneously.

2. Replace the sterile filter or sterilize the current


sterile filter, see Sterilizing the sterile filter
[} Page 44].

43
9 Maintenance

3. Exert a little pressure on the sterile filter and turn to


insert it into the holding sockets.

Sterilizing the sterile filter

1. Remove the sterile filter by turning and pulling it from


the holding sockets simultaneously.

2. Slide a into the steam sterilizer and place the sterile


filter vertically on the tray. Ensure that the sterile filter
does not fall over, otherwise the condensate will not
be able to drain away correctly.

3. Start the Gentle-Program.

4. Remove the sterile filter from the device after the


program end and allow it to cool for min. 15 min.

5. Exert a little pressure on the sterile filter and turn to


insert it into the holding sockets.

44
9 Maintenance

Cleaning the filter in the sterilization chamber


1. Unscrew the two fixing screws on the metal cover in
the sterilization chamber (using e.g. a coin) and
remove the metal cover.

2. Unscrew the “condensate return” (pos. a) and


“vacuum / flow” (pos. b) filters anti-clockwise out of
the opening to check and clean.

Use the spanner included in the scope of delivery a


(pos. c) to unscrew the “vacuum / flow” filter.

3. Rinse the filter (pos. a and b) for cleaning with


water.

4. Screw in the “condensate return” filter (pos. a) and


the “vacuum / flow” filter (pos. b) clockwise into the
opening.

5. Fasten the metal cover in the sterilization chamber


with the two fixing screws.

Maintenance
Comply with the following for safe handling:
u Maintain the specified maintenance intervals. Continuing operation beyond the maintenance interval
can result in malfunctions in the device.
u Have maintenance performed only by trained and authorised technicians using the original MELAG
maintenance set.
u If components that are not included in the maintenance set have to be replaced during maintenance,
only original spare parts from MELAG may be used for the replacement.
Regular maintenance is vital to ensure reliable operation and value retention of the steam sterilizer. All
function and safety-relevant components and electrical units must be checked during maintenance and
replaced where necessary. Maintenance is performed in accordance with the maintenance instructions
pertinent to this steam sterilizer.
Arrange for regular maintenance in 24 month intervals or after 1000 program cycles. The steam sterilizer
will issue a maintenance message at the relevant time.

45
10 Pause times

10 Pause times

Frequency of sterilization
Pause times between individual programs are not necessary. After the end/abort of the drying time and
removal of the sterile material, you can load the steam sterilizer again and start a new program.

Operating pauses
Depending on the duration of the operating pauses, the following measures must be maintained:

Duration of the operating pause Measure


Short pauses between two sterilization ▪ Keep the door closed to save energy
processes
Pauses which last longer than an hour ▪ Switch off the steam sterilizer
Longer pauses e.g. over night or the ▪ Switch off the steam sterilizer
weekend ▪ Leave the door ajar to prevent premature wear and the
sticking of the door seal
▪ If present, shut off the water inflow of the water treatment unit
Longer than two weeks ▪ Switch off the steam sterilizer
▪ Leave the door ajar to prevent premature wear and the
sticking of the door seal
▪ If present, shut off the water inflow of the water treatment unit
Upon re-commissioning:
▪ Perform a vacuum test
▪ After a successful vacuum test, perform an empty sterilization
run in Quick-Program S
After pauses, perform the checks described in chapter Function checks [} Page 38] depending on the
length of pause.

Decommissioning
When decommissioning the steam sterilizer for a long pause (e.g. due to holiday or planned transport),
proceed as follows:
1. Empty the storage tank, see Internal storage tank [} Page 41].
2. Switch off the device at the power switch.
3. Disconnect the power plug from the socket.
4. Clean the supply tank, see Internal storage tank [} Page 41].
5. Close the water inflow if you are using a water treatment unit.

46
10 Pause times

Transport

Transport within the practice

NOTICE
Failure to observe these provisions can result in damage to the device and malfunction.

Comply with the following provisions when transporting within a room or the practice:
u When using a water treatment unit and/or an outlet hose, close the water inflow and remove the hose
connections on the rear of the device.
u Should you wish to leave the mount and trays or sterilization containers in the sterilization chamber
during transport, protect the surface of the round blank. To do so, place e.g. some foam or bubble
wrap between the round blank and mount.
u Close the device door before moving the device.

Transport over long distances

NOTICE
Damage to the housing and the device interior as a result of using unsuitable transport
packaging.
n Only transport the device in its original packaging or other suitable packaging.

Comply with the following provisions when transporting the steam sterilizer (e.g. a move or dispatch):
u Before transporting the steam sterilizer over long distances, before dispatch or given the danger of
frost, an authorized technician must prepare the device in accordance with the instructions and empty
the storage tank entirely.

Recommissioning after relocation


When recommissioning after changing the location of the device, proceed as for initial commissioning, see
Technical manual.

47
11 Malfunctions

11 Malfunctions

Troubleshooting online
All messages with current descriptions can be found in the Troubleshooting portal
on the MELAG website (https://www.melag.com/en/service/troubleshooting).

Warnings
Warnings are not malfunction messages. They help to ensure malfunction-free operation and to recognise
undesirable situations. Comply with these warnings early in order to avoid malfunctions.

Malfunction messages
Malfunction messages are issued on the display with an event number. This number serves identification
purposes. Malfunction messages are issued when it is not possible to ensure safe operation or safety of
sterilization. These can appear on the display shortly after activating the steam sterilizer or during a
program run.
If a malfunction occurs during a program run, the program will be aborted.

WARNING
Danger of contamination as a result of premature program abort
Aborting a program before the drying phase begins means that the load is unsterile.
n Re-pack the load if necessary.
n Repeat the sterilization of the load.

Before contacting customer services


Ensure that you have complied with all instructions relating to a warning or malfunction message issued by
the display of the device. The following table contains a summary of the most important events. The
events contain possible causes and the corresponding operator information.
Should the following table not contain the relevant event, or your efforts do not redress the problem, you
can contact your nearest stockist or a local authorised MELAG customer service provider. Please have the
serial number of your device and a detailed description of the message ready.

48
11 Malfunctions

Warnings
Event Possible causes What you can do
Notice: no feed water / There is insufficient feed water in the Check the water level of the feed water in
refill feed water – start internal storage tank. the internal storage tank and refill with feed
not possible water if necessary.
Notice: no feed water/ When using the internal storage tank:
check the feed water The warning message will be dis- Upon repeated incidence, contact an au-
inflow played after a program start. The in- thorised customer services / stockist tech-
stalled flow monitor does not close. nician.
When using a MELAG water treatment unit:
The warning message will be dis- MELAdem 40/53/53 C:
played after a program start. The in- Check the water treatment unit and open
stalled flow monitor does not close. the inflow to the system if necessary. Upon
repeated incidence, contact an authorised
customer services / stockist technician.
MELAdem 47:
Check the water treatment unit and if ne-
cessary, open the inflow to the system.
Perform a new start with an empty pres-
sure storage after approx. 1 hour.
Upon repeated incidence, contact an au-
thorised customer services / stockist tech-
nician.
PLEASE NOTE: This message can be
issued following commissioning/recommis-
sioning, as the pipe system has not been
filled completely. Repeat the start.
Poor feed water/re- The conductivity of the feed water is Start through repeated pressing of the 'S'
place the cartridge or too high. key still possible.
module Conductivity ≥ 40 µS/cm
When using a MELAG water treatment unit:
The mixed-bed resin is exhausted. MELAdem 40:
Replace the mixed-bed resin (art. no.
ME61026), see the user manual of the wa-
ter treatment unit.
The mixed-bed resin in the ion ex- MELAdem 47:
changer (3rd cartridge) is exhausted. Replace the mixed-bed resin (art. no.
ME37470), see the user manual of the wa-
ter treatment unit and check the water
treatment unit.
Following repeated incidence, arrange for
maintenance to be performed by the au-
thorised customer services / stockist tech-
nician. The pre-filter and activated carbon
filter may require changing.
When using a different water treatment unit:
The mixed-bed resin in the reverse Replace the module / resin cartridge in ac-
osmosis unit is exhausted. cordance with the manufacturer's user
manual. Maintenance is required following
repeated incidence.
PLEASE NOTE: Perform a program start
after completing the work outlined above.
This warning can be issued upon the initial
start after maintenance of the water treat-
ment unit, as the inlet hose / the measure-
ment cell have not been completely rinsed
with fresh water.

49
11 Malfunctions

Event Possible causes What you can do


Feed water quality in- Feed water conductivity too high. Start no longer possible.
sufficient / Start not Conductivity ≥ 65 µS/cm See event: Feed water quality bad (Re-
possible place cartridge/module).
Please wait / Preheat- This message appears during the The steam sterilizer starts automatically
ing chamber program start phase. The steam after the starting temperature has been
sterilizer has not yet reached the reached.
starting temperature.
Notice: change the The min./max. pressure is exceed- Replace the sterile filter.
sterile filter ed/undercut during air drying; the PLEASE NOTE: The message is issued at
sterile filter is soiled or torn. the end of the program and in the last line
of the log output.
Output medium is not The steam sterilizer is operating Working in the Log output menu, set
ready without an output medium, but one the option No output medium.
has been registered.
The output medium has not been Check that the data cable has been con-
connected properly. nected to the steam sterilizer and output
medium correctly
The electricity supply to the printer Make sure that the power supply is con-
has been interrupted. nected.
MELAprint 42/44: The red LED “P” on the
printer must be red.
MELAprint 80: The LED on the printer
must be green.
The printer is “offline“. Set the printer to “online”.
MELAprint 42/44: Press the ‘SEL’ key.
The ‘SEL’ LED must be green.
MELAprint 80: The LED on the printer
must be green.
Log memory full The internal log memory of the de- The notification is displayed upon program
vice is full (max. 40 logs possible) start.
Repeated pressing of the 'S' key removes
the message and the program starts. The
oldest log will be deleted in the process.
An output medium has been regis- 1. Set the steam sterilizer to Immediate
tered and the option Immediate output YES see Outputting logs
output NO has been set in the Log immediately and automatically
output menu. [} Page 33].
2. Delete the internal device memory,
see Deleting logs in the internal log
memory [} Page 36]. If necessary,
output all previously saved logs, see
Subsequent log output [} Page 34].
3. Working in the Log output menu,
log off the output medium and set
the No output medium option.
Carry out mainte- The maintenance message is acti- The message is displayed upon every pro-
nance vated. The device has reached the gram start.
set number of batches or the running Repeated pressing of the 'S' key removes
time of 24 months. the message and the program starts.
Retain the message: Press the 'S' key
twice to start.
Arrange for maintenance by the authorized
customer services/stockist technician.
PLEASE NOTE: The maintenance counter
is reset by the customer services.

50
11 Malfunctions

Event Possible causes What you can do


Vacuum test unsuc- The leakage rate determined during 1. Check the door seal and the chamber
cessful the vacuum test lies over the maxi- flange for soiling and clean if
Leakage rate: mum permissible value of 1.3 mbar. necessary.
> 1.3 mbar The door seal and/or chamber 2. Check the door seal for damage and
flange is soiled. change if necessary, see Replacing
the door seal [} Page 42].
3. Repeat the vacuum test with a cold
device, see Vacuum test [} Page 38].
The incline to the steam sterilizer is Check the incline of the steam sterilizer to
too flat. the rear. Complete condensate drainage
from the chamber is only possible with a
sufficient rearwards incline.
Starting from a level position, extend the
foremost device feet for the
Euroklav 23 VS+ by 5 or 3 rotations for the
Euroklav 29 VS+.
The “vacuum / flow” filter is soiled. Unscrew the “vacuum / flow” chamber filter
(in the fore area of the sterilization cham-
ber) and check for soiling. Clean the filter if
necessary, (see Cleaning the filter in the
sterilization chamber [} Page 45]).
The sterilization chamber is too hot. Allow the steam sterilizer to cool and rub
the sterilization chamber dry with a non-
fuzzing cloth.
PLEASE NOTE: The sterilization chamber
must be dry and cold to ensure a success-
ful vacuum test.
Notice! Battery empty Monitoring of the internal battery Have the battery replaced by an authorised
voltage has returned a low value. technician.

51
11 Malfunctions

Fault messages
Event Possible causes What you can do
F01 The door seal and/or the seal face on Check the door seal and the seal face on the sterili-
the sterilization chamber is soiled or the zation chamber for soiling and foreign bodies and
door seal is defective. clean them if necessary. Check the door seal for de-
fects and replace if necessary, see Replacing the
door seal [} Page 42].
The door seal was not inserted correct- Check whether the door seal has been inserted cor-
ly. rectly, see Replacing the door seal [} Page 42]. In-
sert the new door seal in the groove in such a way
that the wider seal face points towards the side of
the sterilization chamber.
The incline to the steam sterilizer is too Check the incline of the steam sterilizer to the rear.
flat. Complete condensate drainage from the chamber is
only possible with a sufficient rearwards incline.
Starting from a level position, extend the foremost
device feet for the Euroklav 23 VS+ by 5 or 3 rota-
tions for the Euroklav 29 VS+.
The pressure release of the sterilization Unscrew the “vacuum/flow” chamber filter (in the
chamber is blocked. fore area of the sterilization chamber) and check for
soiling. Clean the filter if necessary, (see Cleaning
the filter in the sterilization chamber [} Page 45]).
The surrounding temperature of the The ambient temperature must amount to < 40 °C.
steam sterilizer is too hot. We recommend a maximum temperature of 25 °C.
The minimum clearance to the sur- Maintain a minimum clearance to the surrounding
rounding surfaces has not been main- surfaces (see information in the technical manual).
tained. The device may only be installed if sufficient ventila-
tion can be guaranteed.
The outlet opening of the evaporator Check the outlet opening of the evaporator coil as
coil in the left-hand chamber of the stor- follows:
age tank (wastewater side) is impeded. 1. Remove the tank lid from the internal storage
tank.
2. Remove the filling funnel.
3. Check whether the outlet opening of the
evaporator coil at the front underneath the tank
lid is blocked or the rubber panel obscures the
opening.
F02 The overheat protection has tripped. Press the overheat protection reset button on the
fore side of the steam sterilizer at the bottom right-
hand side (behind the panel) back in.
The steam sterilizer is overloaded. Comply with the maximum permissible load quanti-
ties, see Loading the steam sterilizer [} Page 22].
The incline of the steam sterilizer is in- Check the incline of the steam sterilizer to the rear.
correct. Only a correct incline guarantees optimal metering of
the water volume.
Starting from a level position, extend the foremost
device feet for the Euroklav 23 VS+ by 5 or 3 rota-
tions for the Euroklav 29 VS+.
The mains voltage is too low, poor Check the building-side socket / test the steam
building voltage supply (e.g. undersized sterilizer using a different socket or circuit.
installation, defective socket, multiple
devices on a single socket/fuse) so that
the steam generator cannot heat up.

52
11 Malfunctions

Event Possible causes What you can do


F04 The “condensate return” filter is soiled. 1. Unscrew the two fixing screws on the metal
cover in the sterilization chamber with an object
e.g. a coin.
2. Remove the metal cover.
3. Unscrew the “condensate return” filter (in the
rear of the sterilization chamber).
4. Check the “condensate return” filter for soiling
and clean it if necessary, see Cleaning the filter
in the sterilization chamber [} Page 45].
The outlet opening of the evaporator Check the outlet opening of the evaporator coil as
coil in the drain water side of the stor- follows:
age tank (left) is impeded. 1. Remove the tank lid from the internal storage
tank.
2. Remove the filling funnel.
3. Check whether the outlet opening of the
evaporator coil at the front underneath the tank
lid is blocked or the rubber panel obscures the
opening.
F08 The internal device time monitoring is Check the building-side socket / test the steam
defective. sterilizer using a different socket or circuit. Upon re-
peated incidence, arrange for an electrician to check
the electricity supply for electromagnetic disruption.
F09 The door has not been closed correctly Close the door correctly and start the program again.
upon program start. PLEASE NOTE: To shut the door correctly, press it
against the steam sterilizer lightly and slide the slide
locking grip downwards to its fullest extent.
An attempt was made to open the door Do not attempt to open the door during a program
during a program run. run.
F10 The overheat protection of the tubular Allow the steam sterilizer to cool for approx. 2 min
heating element has triggered. and then restart the program.
PLEASE NOTE: This notification can be issued if a
program is started immediately after a malfunction or
a program abort.
The incline of the steam sterilizer is in- Check the incline of the steam sterilizer to the rear.
correct. Only a correct incline guarantees optimal metering of
the water volume.
Starting from a level position, extend the foremost
device feet for the Euroklav 23 VS+ by 5 or 3 rota-
tions for the Euroklav 29 VS+.
F12 The door has not been closed correctly. To shut the door correctly, press it against the steam
sterilizer lightly and slide the slide locking grip down-
wards to its fullest extent.
The locking pin for the door is stiff. Open the door, switch off the steam sterilizer and
press in the locking pin by hand. The pin must be
free-moving. If necessary, clean the locking pin.
F18 Malfunction on the specified sensor in- Upon repeated occurrence, please inform an author-
put ised technician.
With “Malfunction 18 Sensor: 6 Input: 6” Check whether the water used as feed water actual-
an excessively high conductivity of the ly corresponds to the required quality or e.g. tap wa-
feed water supply can be measured. ter has been used. The feed water must fulfil the
quality requirements of EN 13060, Appendix C. If tap
water has been used, restart the steam sterilizer two
to three times so as to flush out the tap water from
the system.
F21 The monitoring time of the preheating Upon repeated incidence, contact an authorized cus-
was exceeded. tomer services/stockist technician.

53
11 Malfunctions

Event Possible causes What you can do


F22 The maximum preheating temperature Upon repeated incidence, contact an authorized cus-
has been exceeded. tomer services/stockist technician.
F23 The pressure release of the sterilization Unscrew the “vacuum / flow” chamber filter (in the
chamber is blocked. fore area of the sterilization chamber) and check for
soiling. Clean the filter if necessary (see Cleaning
the filter in the sterilization chamber [} Page 45]).
The outlet opening of the evaporator Check the outlet of the evaporator coil as follows:
coil in the left-hand chamber of the stor- 1. Remove the tank lid from the internal storage
age tank (wastewater side) is impeded. tank.
2. Remove the filling funnel.
3. Check whether the outlet opening of the
evaporator coil at the front underneath the tank
lid is blocked.
F26 The internal computer signal processing Arrange for an inspection of the building-side instal-
has been interrupted. lation (e.g. automatic circuit breaker) and test the
steam sterilizer at another socket or on another cir-
cuit. Upon repeated incidence, contact an authorized
customer services/stockist technician.
F27 The max. permissible temperature dif- Arrange for an inspection of the building-side instal-
ference has been exceeded. lation (e.g. automatic circuit breaker) and test the
steam sterilizer at another socket or on another cir-
cuit. Upon repeated incidence, contact an authorized
customer services/stockist technician.
F29 Insufficient battery voltage in the device. Arrange for the battery to be replaced by an author-
ized customer services/stockist technician.
1. Acknowledge the malfunction message and then
reset the date and time, see Setting the date
and time [} Page 20].
2. Start the program again.
F31 During the vacuum test, the the permis- Allow the steam sterilizer to cool and rub the sterili-
sible maximum pressure was exceeded zation chamber dry with a non-fuzzing cloth.
after the evacuation pressure had been PLEASE NOTE: The sterilization chamber must be
achieved (serious leak). dry and cold to ensure a successful vacuum test.
The sterilization chamber is too hot or
too damp.
The door seal and/or the seal face on Check the door seal and the seal face on the sterili-
the sterilization chamber is soiled or the zation chamber for soiling and foreign bodies and
door seal is defective. clean them if necessary. Check the door seal for de-
fects and replace if necessary. See Replacing the
door seal [} Page 42].
The door seal was not inserted correct- Check whether the door seal has been inserted cor-
ly. rectly. See Replacing the door seal [} Page 42]. In-
sert the new door seal in the groove in such a way
that the wider seal face points towards the side of
the sterilization chamber.

54
11 Malfunctions

Event Possible causes What you can do


F32 The steam sterilizer was switched off at Replace or sterilize the sterile filter as follows:
the power switch during a program run. 1. Remove the sterile filter from the rear panel of
the steam sterilizer and sterilize it in
the Gentle-Program without continuing
loading.
2. Return the sterile filter to the rear panel.
Never switch off the steam sterilizer at the power
switch during a program run. Always abort a pro-
gram with the 'Start-Stop' key.
The power plug has been disconnected Check whether the power plug is connected, the
or has not been connected correctly in power cable has suffered damage, or a loose con-
the socket. tact or loose plug connections is the cause. Plug the
power plug back into the mains socket.
Power failure in the building supply. Arrange for an inspection of the building-side instal-
lation (e.g. automatic circuit breaker) and test the
steam sterilizer at another socket or on another cir-
cuit.
F33 The control pressure has not been Upon repeated incidence, contact an authorized cus-
achieved. tomer services/stockist technician.
The steam sterilizer is overloaded.
F35 The sterilization temperature on temper- Upon repeated incidence, contact an authorized cus-
ature sensor 1 was exceeded. tomer services/stockist technician.
F36 The required chamber pressure was un- Comply with the maximum permissible load quanti-
dercut during sterilization. ties, see Loading the steam sterilizer [} Page 22]. If
The steam sterilizer may be overloaded. necessary, perform a vacuum test, see Vacuum test
[} Page 38].
The door seal and/or the seal face on Check the door seal and the seal face on the sterili-
the sterilization chamber is soiled or the zation chamber for soiling and foreign bodies and
door seal is defective. clean them if necessary. Check the door seal for de-
fects and replace if necessary. See Replacing the
door seal [} Page 42].
The door seal was not inserted correct- Check whether the door seal has been inserted cor-
ly. rectly. See Replacing the door seal [} Page 42]. In-
sert the new door seal in the groove in such a way
that the wider seal face points towards the side of
the sterilization chamber.
F37 The max. permissible sterilization pres- Upon repeated incidence, contact an authorized cus-
sure has been exceeded. tomer services/stockist technician.
F38 The max. permissible temperature dif- Upon repeated incidence, contact an authorized cus-
ference on temperature sensor 1 has tomer services/stockist technician.
been exceeded.
F39 The internal memory (EEPROM) has 1. Acknowledge the malfunction message and if
suffered data inconsistency or data necessary, reset the date and time, see Setting
loss. the date and time [} Page 20].
2. Start the program again.
F41 see event F23

55
11 Malfunctions

Event Possible causes What you can do


F42 The door seal and/or the seal face on Check the door seal and the seal face on the sterili-
the sterilization chamber is soiled or the zation chamber for soiling and foreign bodies and
door seal is defective. clean them if necessary. Check the door seal for de-
fects and replace if necessary, see Replacing the
door seal [} Page 42].
The door seal was not inserted correct- Check whether the door seal has been inserted cor-
ly. rectly, (see Replacing the door seal [} Page 42]). In-
sert the new door seal in the groove in such a way
that the wider seal face points towards the side of
the sterilization chamber.
The incline to the steam sterilizer is too Check the incline of the steam sterilizer to the rear.
flat. Complete condensate drainage from the chamber is
only possible with a sufficient rearwards incline.
Starting from a level position, extend the foremost
device feet for the Euroklav 23 VS+ by 5 or 3 rota-
tions for the Euroklav 29 VS+.
The sterile filter is soiled. Remove the sterile filter from the rear panel of the
steam sterilizer. Check the sterile filter for soiling and
perform an empty sterilization run without a sterile fil-
ter. If the empty sterilization run is successful, re-
place the sterile filter (see Replacing or sterilizing the
sterile filter [} Page 43]).
F48 Parameter malfunction Switch off the steam sterilizer and back on again and
then restart the program. Upon repeated incidence,
contact an authorized customer services/stockist
technician.
F51 The sterilization temperature on temper- Comply with the maximum permissible load quanti-
ature sensor 2 was undercut. ties, see Loading the steam sterilizer [} Page 22]. If
The steam sterilizer may be overloaded. necessary, perform a vacuum test, see Vacuum test
[} Page 38].
The door seal and/or the seal face on Check the door seal and the seal face on the sterili-
the sterilization chamber is soiled or the zation chamber for soiling and foreign bodies and
door seal is defective. clean them if necessary. Check the door seal for de-
fects and replace if necessary. See Replacing the
door seal [} Page 42].
The door seal was not inserted correct- Check whether the door seal has been inserted cor-
ly. rectly. See Replacing the door seal [} Page 42]. In-
sert the new door seal in the groove in such a way
that the wider seal face points towards the side of
the sterilization chamber.
F52 The sterilization temperature on temper- If necessary, perform a vacuum test, see Vacuum
ature sensor 2 was exceeded. test [} Page 38]. Upon repeated incidence, contact
an authorized customer services/stockist technician.
F53 The max. permissible temperature dif- Upon repeated incidence, contact an authorized cus-
ference on temperature sensor 2 has tomer services/stockist technician.
been exceeded.

56
11 Malfunctions

Opening the door in an emergency following a power outage

WARNING
The steam sterilizer must be completely pressure free.
Failure to observe this provision can result in scalding/injury.
n No steam may be permitted to leave from between the sterile filter and the rear panel of the
steam sterilizer.
n The slide locking grip must be easy to actuate.
n It must be possible to push the door approx. 2 mm to the rear with light pressure.
n It is imperative that you allow the steam sterilizer to cool. Metal parts such as the door and
sterilization chamber can be hot.

If the door cannot be opened, e.g. due to a power failure, please proceed as follows, observing the safety
information provided above:
1. Switch off the steam sterilizer at the mains and
remove the plug from the socket.

2. Position long side of the lever between the door and


the side wall of the steam sterilizer. The curve points
forwards and the lever is at the level of the slide
locking grip.

If the lever is in the guide, pull it forwards with your


right hand. Push the slide locking grip upwards with
your other hand.

Display with door unlocked

3. Open the door.

57
11 Malfunctions

Replacing the device fuses


If the device fuses have tripped, proceed as follows to replace them:
1. Switch off the steam sterilizer at the mains and
remove the plug from the socket.

2. Open the door manually, see Emergency door


opening in case of power failure [} Page 57].

3. Unscrew and remove both caps on the fuse holder on


the lower front of the steam sterilizer with a
screwdriver or coin.

Two replacement fuses are mounted on the inside of


the door (see marking).

4. Remove the defective fuses and insert the new fuses


securely in their holder.

5. Screw the cap of the fuse holder to the lower front


of the steam sterilizer.

6. Reconnect the steam sterilizer plug to the socket


and switch on the steam sterilizer at the power
switch.
Should this trigger repeatedly, inform the authorised customer services / stockist technician.

58
12 Technical data

12 Technical data

Device type Euroklav 23 VS+ Euroklav 29 VS+


Device dimensions (H x W x D) 49 x 42.5 x 70 cm 49 x 42.5 x 62 cm
Empty weight 45 kg 42 kg
1)
Operating weight 56 kg 52 kg
Sterilization chamber
Diameter 25 cm
Depth 45 cm 35 cm
Volume 22.6 l 17 l
Electrical connection
Power supply 220-240 V, 50/60 Hz
Max. voltage range 207-253 V
Electrical power 2300 W 2100 W
Building fuse protection separate power circuit with 16 A fuse, 30 mA RCD protection
Overvoltage category transient overvoltages up to the values of overvoltage category II
(in accordance with EN 61010-1)
Degree of air pollution category 2
(in accordance with EN 61010-1)
Length of the power cable 1.35 m
Ambient conditions
Installation location interior of a building
Noise emission 64 dB(A)
Waste heat (with max. load) 0.9 kWh 0.8 kWh
Ambient temperature 5-40 °C (ideal range 16-26 °C)
Relative humidity max. 80 % at temperatures of up to 31 °C, max. 50 % at 40 °C
(decreasing in linear fashion in-between)
Degree of protection IP20
(in accordance with IEC 60529)
Max. altitude 2000 m
Feed water connection1)
Water quality distilled or demineralized feed water in accordance with EN 13060,
Appendix C (with central demineralization system
max. conductivity 5 µS/cm)
Recommended flow pressure 1.5 bar at 3 l/min
Min. water pressure (static) 2 bar
Max. water pressure (static) 10 bar
Max. water consumption 700 ml 600 ml
Min. filling volume (internal storage 1l
tank, feed water side)
Volume (internal storage tank, 4 l (approx. 7 cycles)
feed water side)
Wastewater connection
Max. water temperature 70 °C2)
Volume (internal storage tank, 3l
waste water side)

1)
When using a water treatment unit.
2)
Optional: automatically via the one-way drain with the MELAG upgrade kit for the tank drain

59
13 Accessories and spare parts

13 Accessories and spare parts

You can obtain the specified articles and an overview of further accessories from your stockist.

Category Article Art. no.


23 VS+ 29 VS+
Chamber Chamber
depth 45 cm depth 35 cm
Mounts Mount A Plus ME82630 ME82620
for 5 trays or 3 sterilization containers
Mount D ME46840
for 2 high cassettes or 4 trays
Sterilization container with 15K (18 x 12 x 4.5 cm) ME01151
disposable paper filters in 15M (35 x 12 x 4.5 cm) ME01152 --
accordance with EN 868-8
15G (35 x 12 x 8 cm) ME01153 --
(depth x width x height)
17K (20 x 14 x 5 cm) ME01171
17M (41 x 14 x 5 cm) ME01172 --
17G (41 x 14 x 9 cm) ME01173 --
23M (42 x 16 x 6 cm) ME01231 --
23G (42 x 16 x 12 cm) ME01232 --
28M (32 x 16 x 6 cm) ME01284
28G (32 x 16 x 12 cm) ME01285
Package holder Package holder (Ø 25 cm) ME22420 ME22410
Trays Tray ME00230 ME00280
Water treatment unit MELAdem 40 ion exchanger ME01049
MELAdem 47 reverse osmosis unit ME01047
MELAjet spray pistol ME27300
For the documentation MELAflash CF-Card-Printer incl. CF card and ME01039
card reader
MELAnet Box ME40296
MELAprint 44 log printer ME01144
MELAprint 80 universal printer ME01108
Serial interface cable, MELAprint 80 ME15823
Other Chamber Protect chamber cleaning set ME01081
Spare parts Water stop (leakage water detector with shut-off ME01056
valve and probe)
Device fuses 20 A gRL ME57589
Door seal ME58512
Sterile filter ME20160
Slide clips for mounts Plus, 10 pcs. ME81235

60
Glossary

Glossary
Air leakage Corrosion
An air leakage is a location through which air can Corrosion is the chemical alteration or destruction
pass in or out without this being desired. The of metallic materials by water and chemical
verification of the leakage serves to prove that the substances.
volume of air ingress in the sterilization chamber
during the vacuum phase does not exceed a value Delay in boiling
which would prevent steam penetration of the load Superheating is the phenomenon that it is possible
and that the air leakage does not cause the under certain circumstances to heat liquids beyond
possible contamination of the load during the their boiling point without them boiling. This
drying phase. condition is unstable. Low-level agitation can
produce a large bubble within the shortest period;
AKI this can expand explosively.
AKI is the abbreviation for “Arbeitskreis
Instrumentenaufbereitung” [Instrument Demineralised water
Reprocessing Working Group]. Demineralised water does not contain minerals
that are found in normal spring or tap water. It is
Authorised technician obtained from tap water by ion exchange and used
An authorised technician is a person intensively as feed water.
trained and authorised by MELAG who has
sufficient specific device and technical knowledge. DGSV
to perform maintenance and installation work on DGSV is the abbreviation for “Deutsche
MELAG devices. Only they may carry out this Gesellschaft für Sterilgutversorgung” [German
work. Society for Sterile Supply]. The training guidelines
of the DGSV are listed in DIN 58946, Part 6 as
Batch requirements for personnel.
The batch is the composition of items which has
been subject to the same reprocessing procedure. DGUV Regulation 1
DGUV is the abbreviation for “Deutsche
Bowie & Dick test Gesetzliche Unfallversicherung” [German Statutory
The Bowie & Dick test is a vapour penetration test Accident Insurance]. The regulation 1 governs the
with standard test package (see EN 285). This test principles of prevention.
is recognised in large-scale sterilization.
DIN 58953
CF card Standard for “Sterilization – Sterile supply”
The CF card is a memory medium for digital data;
Compact Flash is an official standard, i.e. these Distilled water
memory cards can be used in every device fitted Distilled water is largely free of salts, organic
with the corresponding slot. The CF card can be substances, and micro-organisms. It is obtained by
read by every device that supports the standard distillation (evaporation and subsequent
and where necessary, written on. condensation) from normal tap water or pre-
purified water. Distilled water is used as feed
Competent personnel water.
Trained personnel in accordance with national
specifications for the respective area of application Dynamic pressure test
(dentistry, medicine, podiatry, veterinary medicine, The dynamic pressure test serves to prove that the
cosmetics, piercing, tattoo) with the following rate of pressure variations in the sterilization
contents: knowledge of instruments, hygiene and chamber during a sterilization cycle does not
microbiology, risk assessment and classification of exceed a particular value which could result in the
medical devices and instrument reprocessing. damage of the packaging material, see EN 13060.

Condensate Empty chamber test


Condensate is a liquid (e.g. water) that emerges The empty chamber test is a test without a load
from the vapour state when cooled and thus and is performed to assess the performance of the
separates. steam sterilizer without the influence of a load.
This allows the temperatures and pressures
Conductivity obtained to be checked against the intended
Conductivity is the ability of a conductive chemical settings, see EN 13060.
substance or mixture of substances to conduct or
transfer energy or other substances or particles in EN 13060
space. Standard for “Small steam sterilizers”

61
Glossary

EN 13060 L ≤ 1500 mm. The following applies for an article


Standard for “Small steam sterilizers” open on both sides: 2 ≤ L/D ≤ 1500 and L ≤ 3000
mm and which does not correspond to the hollow
EN ISO 11607-1 body B (L = hollow body length, D = hollow body
Standard for “packaging for medical devices to be diameter), see EN 13060.
sterilized in the final packaging – Part 1:
Requirements placed on materials, sterile barrier Qualified electrician
systems, and packaging systems” The qualified electrician has the suitable technical
training, knowledge, and experience to recognise
Feed water and avoid hazards that can be caused by
Feed water is required to generate the water electricity, see IEC 60050 or for Germany
vapour for sterilization; guide values for water VDE 0105-100.
quality in accordance with EN 285 or EN 13060 –
Appendix C. Reprocessing
Reprocessing is a measure to prepare a new or
Heat-up phase used healthcare device for its intended purpose.
The heating time is the time required for the Reprocessing includes cleaning, disinfection,
double-jacket steam generator to heat up after the sterilization and similar procedures.
device has been switched on or after a
reprocessing program has been started before the RKI
sterilization process starts. The duration depends RKI is the abbreviation for “Robert-Koch Institut”
on the sterilization temperature. [Robert Koch Institute]. The Robert Koch Institute
is the central institution for the detection,
Load prevention, and control of diseases, especially
The load includes products, equipment, or infectious diseases.
materials that are reprocessed together in one
operating cycle. Simple hollow bodies
A simple hollow body is either open on one side or
Mixed loads both sides, see EN 13060. The following applies
The load within a batch includes both packed and for an article open on one side: 1 ≤ L/D ≤ 5 and
unpacked products. D ≥ 5 mm. The following applies for an article open
on both sides: 2 ≤ L/D ≤ 10 and D ≥ 5 (L = hollow
Multiple wrapping body length, D = hollow body diameter).
The load is sealed in a double layer of film,
instruments wrapped in foil are additionally planed Single wrapping
in a container or containers wrapped in textiles. The load is wrapped once in a sterile barrier
system (e.g. transparent sterilization package).
Porous The opposite of this is multiple wrapping.
Porous describes the property of materials (e.g.
textiles) to allow water, air, or other liquids to pass Soft sterilization packaging
through. A soft sterilization wrapping is a paper bag or a
transparent sterilization package.
Porous full load
The porous full load specification serves to prove Solid
that the values set at the control satisfy the Solid describes the property of a product that is
necessary sterilization conditions in porous loads made of non-porous material that has no bulges or
with the maximum density for whose sterilization a other design features that offer greater or equal
steam sterilizer is designed to EN 13060. resistance to steam penetration than a simple
hollow body.
Porous partial load
The porous partial load specification serves to Solid load
prove that the values set on the control allow The solid load specification serves to prove that
steam to enter the pre-determined test package the necessary sterilization conditions have been
quickly and equally, see EN 13060. reached within the entire load with the values set in
the control. The load must represent the largest
Process evaluation system weight of solid instruments for whose sterilization a
The process evaluation system monitors itself and steam sterilizer is designed to EN 13060.
compares sensors during running programs.
Sterile barrier system
Product with narrow lumen The sterile barrier system is a minimum level of
A product with narrow lumen is either open on one sealed packaging that prevents the entry of micro-
side or on both sides. The following applies for an organisms (e.g. sealed pouches, sealed reusable
article open on one side: 1 ≤ L/D ≤ 750 and containers, folded sterilization wipes) and allows

62
Glossary

for the aseptic delivery of the product at the point


of use.

Sterile material
Sterile goods are successfully sterilized (i.e. sterile)
goods. Sterile goods are also referred to as
batches.

Sterilization chamber
The sterilization chamber is the part of the steam
sterilizer where the load is sterilized.

63
BA_23VS+_29VS+_EN.pdf | Rev. 18 - 23/2994 | Modification date: 2023-12-20
MELAG Medizintechnik GmbH & Co. KG
Geneststraße 6-10
10829 Berlin
Germany
Email: info@melag.com
Web: www.melag.com
Original instructions

Responsible for content: MELAG Medizintechnik GmbH & Co. KG


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