User Manual

MELAtherm® 10 Evolution
Washer-Disinfector
from software version 3.0.20

EN 0197
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 man-
agement system is subject to close monitoring: one instrument to this end is our annual multi-day audit conducted in ac-
cordance 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.
 Contents

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

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

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

Intended use ........................................................................................................................................................................ 8
User benefits........................................................................................................................................................................ 8
Program sequence .............................................................................................................................................................. 9
Process agents .................................................................................................................................................................. 10

4 Description of the device................................................................................................................................................... 11

Scope of delivery ............................................................................................................................................................... 11
Views of the device............................................................................................................................................................ 11
Symbols on the device....................................................................................................................................................... 14
Operating panel and acoustic signal.................................................................................................................................. 15
Menu structure................................................................................................................................................................... 18
Water softening unit........................................................................................................................................................... 19

5 First steps ........................................................................................................................................................................... 20

Setup and installation ........................................................................................................................................................ 20
Water supply...................................................................................................................................................................... 20
Switching the device on and off ......................................................................................................................................... 21
Video tutorials .................................................................................................................................................................... 21
MELAconnect App ............................................................................................................................................................. 22
Opening and closing the door............................................................................................................................................ 22
Manual door emergency-opening ...................................................................................................................................... 22
Inserting the basis basket .................................................................................................................................................. 23
Filling the regenerating salt................................................................................................................................................ 23
Regenerating the water softening unit ............................................................................................................................... 25
Metering process agents ................................................................................................................................................... 25
Holding process agents ready ........................................................................................................................................... 26
Removing air from the metering system ............................................................................................................................ 28

6 Cleaning and disinfection.................................................................................................................................................. 29

Type of load ....................................................................................................................................................................... 29
Wet/dry storage ................................................................................................................................................................. 29
Preparation and pre-cleaning ............................................................................................................................................ 29
Arranging the load ............................................................................................................................................................. 30
Reprocessing hollow-body instruments ............................................................................................................................. 30
Reprocessing dental transmission instruments ................................................................................................................. 31
Reprocessing ophthalmological instruments ..................................................................................................................... 31
Overview of programs........................................................................................................................................................ 33
Selecting, starting and monitoring the program ................................................................................................................. 34
Manual program abort ....................................................................................................................................................... 35
Authentication and batch approval .................................................................................................................................... 36
Contents

Removing the load after program end ............................................................................................................................... 40

7 Logging ............................................................................................................................................................................... 41
Batch documentation ......................................................................................................................................................... 41
Output media ..................................................................................................................................................................... 41
Outputting logs immediately and automatically ................................................................................................................. 42
Subsequent log output....................................................................................................................................................... 43
Deleting the saved logs ..................................................................................................................................................... 44
Determining the format for the program logs ..................................................................................................................... 44
Finding the logs ................................................................................................................................................................. 47

8 Settings ............................................................................................................................................................................... 48
Settings menu.................................................................................................................................................................... 48
Log settings ....................................................................................................................................................................... 49
Setting the date and time................................................................................................................................................... 54
Setting the display brightness............................................................................................................................................ 55
Setting the idle mode ......................................................................................................................................................... 55
Setting the volume of the signal tone................................................................................................................................. 56
Setting the volume of the key tone .................................................................................................................................... 56
Connectivity ....................................................................................................................................................................... 57
Setting the language.......................................................................................................................................................... 57
Setting the water supply .................................................................................................................................................... 58
Setting the water hardness ................................................................................................................................................ 58
Administrative settings....................................................................................................................................................... 59

9 Function checks ................................................................................................................................................................. 64

Automatic and manual function check ............................................................................................................................... 64
Measuring conductivity ...................................................................................................................................................... 64

10 Maintenance...................................................................................................................................................................... 65
Maintenance intervals........................................................................................................................................................ 65
Regular checks and cleaning............................................................................................................................................. 65
Cleaning on demand.......................................................................................................................................................... 67
Avoiding staining................................................................................................................................................................ 68
Replacing the filter in the drying fan .................................................................................................................................. 68
Maintenance ...................................................................................................................................................................... 69
(Process) Validation........................................................................................................................................................... 69

11 Pause times ...................................................................................................................................................................... 70

Decommissioning .............................................................................................................................................................. 70
Transport within the practice.............................................................................................................................................. 71

12 Malfunctions ..................................................................................................................................................................... 72
Displaying events in MELAconnect ................................................................................................................................... 73
Notifications, warning and malfunction messages............................................................................................................. 73

13 Technical data .................................................................................................................................................................. 87

14 Accessories and spare parts .......................................................................................................................................... 89

15 Documentation and approval .......................................................................................................................................... 90

Glossary ................................................................................................................................................................................. 91
 1 General guidelines

1 General guidelines

Please read this user manual carefully before commissioning the device. The manual includes important safety instruc-
tions. 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 down-
load centre at www.melag.com.

Symbols used
Symbol Explanation
Indicates a dangerous situation, which if not avoided, could entail slight to life-threatening
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 Explanation
Universal- Words or phrases appearing on the display of the device are marked as display text.
Program
Prerequisites for the following handling instruction.

Refer to the glossary or another text section.

Information for safe handling.

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 envi-
ronmentally-friendly disposability and can be recycled. Returning the packaging to the material flow reduces the amount
of waste and saves raw materials.
Dispose of waste from process agents in accordance with the specifications in the safety data sheet. Information regard-
ing this topic is provided in the safety data sheets or can be obtained directly from the manufacturer of the process
agents.
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 contained in
subsequent chapters. Use the device only for the purpose specified in these instructions. Failure to comply
with the safety instructions can result in injury and/or damage to the device.

Qualified personnel
n The instrument reprocessing using this washer-disinfector may only be carried out by }competent personnel.
n The operator must ensure that the users are regularly trained in the operation and safe handling of 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 The disconnection device must be freely accessible after installation so that the device can be taken from the elec-
tricity supply at any time.
n DTA device versions are disconnected from the mains via the on-site main switch. DTB device versions disconnect
from the mains by pulling the mains plug from the socket.
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 unplug by pulling on the power cable. Always take a grip on the plug.
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.
Daily operation
n Only reprocess instruments designed by their manufacturer for automatic }reprocessing in a washer-disinfector.
Comply with the instructions issued by the instrument manufacturer in accordance with }EN ISO 17664. It is espe-
cially important to comply with the specifications from the instrument manufacturer regarding cleaning instruments
for the first time after purchasing new instruments.
n Use only original MELAG accessories or those from other suppliers authorised for use by MELAG.
n When using non-MELAG accessories for the mounting of instruments (especially hollow-body instruments) comply
with the information from the manufacturer of the accessories.
n Comply with the specifications of the national standards and directives pertaining to the reprocessing of instruments,
the instrument manufacturer’s reprocessing instructions and those from the }AKI.

6
 2 Safety

n The fore ventilation slots may not be covered.

n Never operate the device unattended (e.g. overnight). Unsupervised operation of the device can result in damage to
the device or your facility and is performed at your own risk. In such a case, MELAG does not accept any liability.
Process agents
n Handle all }process agents with care. The cleaning agents, neutralisers and rinse aids contain irritants and even
caustic substances.
n Comply with the safety instructions in the documentation of the process agents and wear the prescribed protective
equipment.
n In the case of damage, every type of liquids (e.g. in the drawer, in the device floor trough or liquid issued from the
device) could potentially contain aggressive process agents.
Storage and transport
n Avoid frost or extreme heat during the transport and storage. If this cannot be ensured, unpack the device and store
it at room temperature for at least two hours before installation and commissioning.
n Avoid strong shocks/vibrations.
Maintenance
n Maintenance should only be performed by }authorised technicians.
n Maintain the specified servicing intervals.
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 product (e.g. death or serious dete-
rioration in the state of health of a patient) which were presumably caused by the product, 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 MELAtherm 10 Evolution DTA/MELAtherm 10 Evolution DTB is intended for use in a medical context such as a
clinic or medical and dental practices. }EN ISO 15883-1 and -2 defines it as a washer-disinfector intended for }repro-
cessing medical instruments prior to their re-use or a further reprocessing step such as sterilization in a steam sterilizer.
You can subject thermostable medical instruments (i.e. instruments which are heat resistant to a temperature of 95 °C)
and invasive thermostable instruments to automatic reprocessing as long as they are suitable for this purpose and have
been approved for such treatment by their manufacturer. The cleaning is performed using water in combination with
a }process agent. Subsequent disinfection is thermal disinfection. This device is not intended to be used in a patient
environment.
This device is NOT suitable for the reprocessing of:
n Thermo-unstable instruments e.g. flexible endoscopes
n Laboratory waste requiring disposal
n Crockery
n Bedpans

User benefits
Universal use
The device both cleans and disinfects. The disinfection phase is conceived so as to reach an }A0 value of at least 3000.
This kills vegetative bacteria, fungi and their spores and viruses (incl. HBV, HCV). This means that the }effectiveness
range AB is reached in accordance with the specifications of the Robert Koch Institute.

Active drying
The device is equipped with active drying. An integrated drying fan dries the instruments from outside and in after clean-
ing and disinfection. The HEPA filter guarantees drying with contamination and particle-free air. This protects the instru-
ments against corrosion. Manual subsequent drying is usually not necessary. The geometry of some hollow-body instru-
ments mean that they require additional drying.

Automatic sieve recognition

The device recognises automatically before a program start whether the fine sieve has been inserted in the base of the
washing chamber. The fine sieve avoids a situation in which instrument components enter the opening of the drain pump
or the circulating pump during cleaning, thereby compromising the function of the pumps, rinse arms and the injector rail.

Internal water softening

The device is equipped with an internal water softening unit. The water hardness of the local drinking water is set on the
device. The internal water softening unit then automatically adjusts itself to the most suitable performance. This ensures
best reprocessing results.

Monitoring the rotation speed of the rinse arms

The rotation speed of the rinse arms is subject to permanent monitoring during a program run. This ensures that the
cleaning process proceeds without hindrance and the rinse arms do not become blocked e. g. by protruding instruments
in the washing chamber.

Monitoring the rinsing pressure

The rinse pressure is monitored by a pressure sensor during a program run. This ensures an effective cleaning perfor-
mance. The device aborts a current program if too much foam is generated.

Metering monitoring
The required amounts of cleaning agent and neutraliser are metered using a metering pump. A measuring turbine per-
forms flow monitoring. The rinse aid is metered using a metering pump subject to monitoring for rotation speed.

8
 3 Performance specifications

Drawer for process agents

The drawer for the }process agents is located in the lower area of the device in which the cleaning agent, neutraliser and
rinse aid containers are stored.

Automatic conductivity measurement

If the device is supplied with }DI water in the final rinse, the DI water fed in is subject to automatic internal conductivity
measurement.

Program sequence
The following program steps are indicated on the display during the program run. The program runs will be significantly
defined through the process-relevant parameters (VRP) specified in the technical manual.

Pre-cleaning
The water-soluble soiling will be rinsed roughly with cold water and removed from the device. This prevents protein fixing
from too high a water temperature; the soiling load of the rinse liquor in the following program steps will be reduced con-
siderably. In Intensive-Program, this step is performed twice.

Cleaning
Water is fed into the washing chamber and heated. When the metering temperature has been reached, a mildly-alkaline
or alkaline }cleaning agent will be metered. Once the cleaning temperature has been reached, the holding time begins,
which ensures a reproducible cleaning effectiveness.

Neutralisation
The cleaned instruments will be freed from alkali residue during neutralisation. At the same time, this prevents the devel-
opment of acid-soluble deposits such as limescale and foreign corrosion. To this end, water will be fed into the washing
chamber, a citric acid or phosphoric acid-based }neutraliser will be metered and short circulation will be performed.

Intermediate rinsing
Water is fed into the washing chamber and circulated cold. This rinses off the neutraliser residue. In Ophthalmo-Pro-
gram, this step is performed twice.

Disinfection
The disinfection is the same as the final rinse. The cleaned and rinsed instruments are subject to thermal disinfection.
Water, preferably }DI water is fed into the washing chamber and heated. When the metering temperature is reached,
a }rinse aid is metered in the Quick-Program, Universal-Program and Intensive-Program. Once the disinfection tempera-
ture has been reached, the holding time begins, which ensures a reproducible disinfectant effect.

Drying
Active drying is effected by drawing ambient air through a class H13 }HEPA filter and heating it. The instruments are
dried inside and out with hot, filtered air.

Displaying the batch counter

The display shows the batch number of the last program run and the total batch counter after every program end or the
end of a program abort.

9
 3 Performance specifications

Process agents
Note the following:
n Use only suitable }process agents. The use of unsuitable process agents can impair the reprocessing result and
material compatibility.
n MEtherm process agents are optimally adapted for the }reprocessing with MELAtherm. The suitability has been
proven in comprehensive cleaning effectiveness and material-compatibility tests.
n Please address all queries relating to the compatibility of process agents with the instruments to the instrument
manufacturer.
n Every change of a process agent in a validated device necessitates revalidation. Comply with all national
regulations.

Pre-set metering concentration

The metering concentrations have been harmonised to MEtherm and are factory-set as follows.

Program }Cleaning agent }Neutraliser }Rinse aid

Universal-Program 6 ml/l 1.5 ml/l 0.3 ml/l
Quick-Program 6 ml/l 1.5 ml/l 0.3 ml/l
Intensive-Program 10 ml/l 1.5 ml/l 0.3 ml/l
Ophthalmo-Program 6 ml/l 1.5 ml/l --------

NOTICE
Only trained and }authorised technicians are permitted to change the metering concentration in due
consideration of the recommended user concentration.

10
 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

▪ MELAtherm 10 Evolution Washer-Disinfector
▪ User manual
▪ Technical manual
▪ Record of installation and setup
▪ Manufacturer’s inspection report and declaration of conformity
▪ Warranty certificate
▪ User manual Accessories for MELAtherm
▪ CF card for documentation purposes
▪ Filling funnel for the regenerating salt
▪ Starter package of regenerating salt
▪ Hose bend for outflow
▪ Ø 16-27/9 clamp for outlet hose
▪ Process agent labels
▪ Magnet pocket for device log book

Views of the device

View from front

1 2

4 1 Operating and display panel

2 Cover plate (optional)
5 3 Power switch
4 Cover for card slot and Ethernet data
6 interface (for service technician)
5 Door handle
7 6 Hinged door, opens forwards
7 Ventilation slots for air outlet
8
8 Drawer handle
9 Drawer for }process agents
9
10 Device foot

10

11
 4 Description of the device

Cover card slot open

11 11 Card slot
12 LED
12 13 Ejection button
14 Ethernet data connection

13

14

View from rear

15 Connection for de-ionised water (}DI

water)
16 Connection for cold water
17 Effluent connection
18 Transport rollers
19 Ethernet data connection for permanent
15 network connection
20 Mains cable
20 16

17
19
18

12
 4 Description of the device

View from inside

21

21 Connection tube for injector rails

22 Cold water (CW) inflow and de-ionised
22 water (DI)
23 Salt container
23 24 Lower rinse arm
25 Coarse and fine sieve

25 24

Process agent drawer, open

26 Drying fan pre-filter

27 Assignment of the process agents
28 Container for rinse aid with suction
lance
29 Suction lance bracket
30 Container for neutraliser with suction
lance
31 Container for cleaning agent with
suction lance
31 30 29 28 27 26

13
 4 Description of the device

Symbols on the device

Manufacturer of the product

Date of manufacture of the product

MD Label as medical product

REF Article number of the product

SN Serial number of the product

Observe user manual or electronic user manual

Do not dispose of product in household waste

0197 In affixing this CE mark, the manufacturer declares that this medical product fulfils the basic
requirements of the Medical Device Directive. The four-digit number confirms that this is monitored
by an approved certification agency.

Permissible temperature range of water supply

Permissible pressure of water supply

Electrical connection of the product: Alternating current (AC)

Required fuse protection of the mains connection, specified in amperes [A]

The WaterMark certificate is a seal of quality for plumbing and drainage products in Australia and
New Zealand.
It confirms that a product meets the requirements of the ABCB (Australian Building Codes Board)
and is approved for application.

Symbols on the power switch

Switching on device

Switching off device

14
 4 Description of the device

Operating panel and acoustic signal

Colour touch display
The operating panel consists of a 7.8-inch touch display.

Status bar

Context menu

LED display

Main area

Action bar

Status bar
The status bar is located at the top edge of the display.
The date and time are permanently displayed.
To the right of the time, the navigation path and page numbers (e.g. 1 / 13 = page 1 of 13) are displayed if there are sev-
eral pages in a menu.
In the event of warning and malfunction messages, the serial number of the device and the ID of the event are displayed.
This is the information that can be transmitted via QR code to MELAconnect or manually to the troubleshooting section of
the MELAG website to access context-sensitive troubleshooting help.

Context menu
The context menu displays the submenus, modes and function buttons temporarily and in a context-dependent fashion.

Button Name Description

VALIDATION MODE The button is displayed when the respective program can be executed in
validation mode.
Press the button to switch to validation mode. Validation mode can only be
performed by the person performing the validation with an appropriate PIN.
MAINTENANCE The button is displayed when the respective program can be executed in
MODE maintenance mode.
Press the button to switch to maintenance mode. Maintenance mode can
only be performed by the service technician with an appropriate PIN.
SETTINGS Press the button to switch to the Settings menu.

STATUS Press the button to switch to the Status menu. Device information and
device status regarding switching and sensor states are displayed.

LICENCE The button is displayed in the Status 1 / 14 menu view.

Press the button to call up the licence information for the device.
DELETE The button is displayed in the Log output > All logs menu.
Press the button to delete all logs in the internal log memory.
QR-CODE The button is displayed in the event of a malfunction.
Press the button to open the additional menu for warning and malfunction
messages.

15
 4 Description of the device

LED display and acoustic signals

The LED display to the left and right of the main area indicates operating states by colour.
An acoustic signal is linked to the colour of the LED display and indicates an expected event.

Colour of the LED Description

Blue ▪ Standby
▪ Readiness after starting the device
▪ User action
▪ Program active/video tutorial running
Green ▪ Program successful
▪ Active drying can be terminated prematurely
▪ Measurement successful
Yellow ▪ Notification (e.g. fill salt storage, start the Regeneration program)
▪ Warning message
▪ Software update active
Red ▪ Malfunction message
▪ Program/measurement not successful due to system abort
▪ Program/measurement not successful due to user abort

Main area
On the left-hand side of the main area, a symbol is displayed to indicate programs, additional programs, logs, program
results, messages, menus or PIN-protected areas.
On the right-hand side is the title bar showing menu items, values, statuses of settings or headings of dialogues. The text
field is below the title bar.
Symbol

Title

Text field

Symbol Name Description

Busy indicator Independent activities such as a program run, log output or software updates
are visualised via animated busy indicator in a clockwise fashion.

successful Symbols designating the program result currently displayed

not successful

16
 4 Description of the device

Symbol Name Description

Notification Symbols to indicate the currently displayed message about an event or the
device status

Warning

Malfunction

Documentation Additional markings that indicate the availability of assistance (e.g. in the
user manual, in MELAconnect or on the troubleshooting area in the MELAG
website) regarding the issue with which the current message is concerned
QR code

Action bar

Button Name Description

BACK Press the button to display the previous view or select a lower parameter.

FORWARDS Press the button to display the next view or to select a higher parameter.

LEAVE Press the button to switch to the higher-level menu.

CONFIRM Press the button to confirm the selection or entry.

EDIT Press the button to change the displayed parameter.

UNLOCK Press the button to unlock the door.

DETAILS Press the button to get more information.

SKIP Press the button to skip steps.

17
 4 Description of the device

Menu structure
Universal-Program
Quick-Program
Intensive-Program
Ophthalmo-Program
Rinsing
Emptying
Conductivity measurement DI
Air removal
Regeneration
Time metering 60 s
Log output
Main menu

Output internal log memory

Select output medium:automatic / CF card / MELAprint / Computer
All logs
Last log
All malfunction logs
Last malfunction log
Log selection
Legend log
Status log
System log
CF card formatting
Multimedia > Video tutorials
Settings
Log settings
CF card
Computer
MELAprint
Immediate output
Log format
Network
Graphic logs
Date
Time
Display brightness
Idle mode in min
Signal tone volume
Key tone volume
Connectivity
Language
DI water
Water hardness in °dH
Administration (Log-in with admin PIN)
User
Authentication
Batch approval
Admin PIN
Diagnosis and service

18
 4 Description of the device

Water softening unit

The tap water is processed in the internal water softening unit to produce an optimal cleaning outcome.
u Use coarse-grain regeneration salt (NaCl) to regenerate the water softening unit.

Water hardness conversion table

°dH mmol/l °f °e °dH mmol/l °f °e °dH mmol/l °f °e
1 0.2 2 2 15 2.7 27 19 28 5.0 50 36
2 0.4 4 3 16 2.9 29 20 29 5.2 52 37
3 0.5 5 4 17 3.1 31 22 30 5.4 54 38
4 0.7 7 5 18 3.2 32 23 31 5.6 56 39
5 0.9 9 7 19 3.4 34 24 32 5.8 58 41
6 1.1 11 8 20 3.6 36 25 33 5.9 59 42
7 1.3 13 9 21 3.8 38 27 34 6.1 61 43
8 1.4 14 10 22 4.0 40 28 35 6.3 63 44
9 1.6 16 12 23 4.1 41 29 36 6.5 65 46
10 1.8 18 13 24 4.3 43 31 37 6.7 67 47
11 2.0 20 14 25 4.5 45 32 38 6.8 68 48
12 2.2 22 15 26 4.7 47 33 39 7.0 70 49
13 2.3 23 17 27 4.9 49 34 40 7.2 72 51
14 2.5 25 18

19
 5 First steps

5 First steps

Setup and installation

PLEASE NOTE
Comply with the specifications of the technical manual during setup and installation. This contains all
building-side requirements.

Record of installation and setup

The record of installation and setup 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.

Water supply
The }reprocessing of medical devices requires the use of potable water in accordance with the Drinking Water Ordi-
nance.
The potable water supply is effected on the input side via the house supply.
The quality of the water used for reprocessing influences the value-retention of the }load. Silicate or chloride cannot be
removed by the internal water softening unit and will result in the development of stains and corrosion. Working in con-
sultation with specialist associations (e.g. in Germany }AKI, }DGSV, }DGKH) MELAG recommends performing a final
rinse with demineralised water (DI water).

PLEASE NOTE
The final rinse and the partial cycle Disinfection are the same in MELAtherm.

During installation, it is determined whether DI water is to be used in the final rinse (partial cycle Disinfection). In addition,
depending on customer-specific requirements, the service technician can parametrise the partial cycles pre-cleaning,
cleaning, neutralising and intermediate rinsing to DI water. The DI water supply is effected via a water treatment unit (e.g.
MELAdem 53/53 C).
Increased requirements can be placed on the quality of the }DI water (e.g. a low endotoxin content) for the }reprocess-
ing of certain medical devices such as ophthalmic instruments.
Comply with the following:
n In such cases, an additional filter system is required for the reprocessing of DI water. Comply with the specifications
of the user documentation of your water treatment unit.
n It is possible that the drinking water has been contaminated by the water installation. This includes both the domestic
installation and the entire upstream peripherals.
n Arrange for a check of the drinking water quality at the removal point or request a report (e.g. from the building
management) before setting up and installing the device.
n Further information is available from the corresponding trade associations and their publications. If in doubt, contact
your stockist or the pertinent professional association.

20
 5 First steps

Switching the device on and off

u Switch the device on or off at the power switch.

Video tutorials
The Multimedia menu contains video tutorials which describe the use of this washer-disinfector in a number of operat-
ing situations.

View of the video control

1 4

2 5

3 6

Button Description Button Description

1 Start/pause 4 Close video
2 Fast forward 5 Sound louder
3 Fast reverse 6 Sound quieter

Access a video as described below.

The following must be fulfilled or present:
ü The device is switched on and the display is in the main menu.

1. Repeatedly press FORWARDS/BACK until the Multimedia menu is

displayed.

2. Press CONFIRM to open the menu.

Ê The first tutorial page is displayed.

3. Press FORWARDS/BACK until the desired tutorial is displayed.

21
 5 First steps

4. Press START to start the video.

Ê The started video will play once.

5. Close the video to return to the media library.

MELAconnect App
You can use the MELAconnect app from any location in your practice, to access the device status and program progress
of the MELAG devices incorporated in your practice network.
MELAconnect provides the following functions:
▪ Accessing the device status and program progress.
▪ Accessing the user manuals and video tutorials for using the device.
▪ Locating malfunctions and accessing solutions and assistance immediately.
▪ Performing quick paperless documentation of routine checks of the MELAG sealing device.
▪ Contacting the }authorised technician (contact data must be entered manually).
In order to connect the MELAconnect app with your MELAG device, see the Connectivity [} page 57] section.

Opening and closing the door

The door is automatically closed via a motor. For this reason, it is important that the device is connected to the power
supply and is switched on. The door unlocks automatically after a successful program run. The door cannot be opened
during a power failure. In this case, operate the Manual door emergency-opening [} page 22].

PLEASE NOTE
The door can only be opened during a program run using a program abort.
The door will be unlocked after the program abort has been acknowledged and sufficient cooling has been
performed.

Opening the door

1. Switch on the device at the power switch.
2. Press UNLOCK to unlock the door.
3. Open the door forwards.

Close the door

u Shut the door upwards and press it until the motorised lock sets in.

Manual door emergency-opening

The door can be opened manually via the emergency opening following a power failure or malfunction.
Note the following:
n Escaping steam brings the danger of scalding.
n Never operate the door emergency-opening mechanism during an active program.
n A program aborted by a door emergency-opening is classed as not having been completed successfully. The
instruments must be reprocessed again.
n Wear suitable protective clothes.

22
 5 First steps

Operating the door emergency-opening

1. If the device is still switched on, switch it off at the power switch.

2. Pull out the process agent drawer.

Ê An emergency-opening grip for the door is located in the front
left-hand side of the device.

3. Pull down on the grip until you hear a clicking sound.

4. Pull the door forwards strongly using the grip.

Inserting the basis basket

A fitting for connecting the injector rail or the blind cap is located on the right-hand rear side of the washing chamber of
the washer-disinfector.

u Slide the basis basket with the injector rail opening or the blind cap
leading into the washing chamber until it connects to the fitting.

Filling the regenerating salt

NOTICE
Malfunctions of the water softening unit from unsuitable regenerating salt.
Fine grain regenerating salt can cause device malfunctions. MELAG does not recommend the use of pellets,
as the salt dissolves too slowly.
n Use only special, coarse grain regenerating salt (additive-free NaCl), e.g. regenerating salt for MELAtherm.
n Never use cooking salt, table salt, de-icing salt, cattle salt or road salt. These salts usually contain
insoluble components.

Filling the regenerating salt for the first time

The first filling of the regenerating salt is to be performed by the }authorised technician whilst commissioning the device.

23
 5 First steps

Refilling with regenerating salt

Video tutorial
See also “Refilling Regenerating Salt”.

Insufficient regenerating salt or its absence will result in the display of the corresponding display message.
▪ If the display shows the message There is almost no regenerating salt left. Re-fill the
regenerating salt soon., fill the regenerating salt immediately, or upon the display of the next message at the
latest.
▪ If the display shows the message The regenerating salt is exhausted. Re-fill the regenerating
salt., you must fill the regenerating salt immediately. Otherwise you will be unable to start a further program.
You can refill the regenerating salt at any time without the display message previously having been shown.
u After filling, start the “Rinsing” program manually in order to rinse away any overflown brine or salt residue from the
washing chamber.
Proceed as follows to refill the regenerating salt:
1. Acknowledge the display message with CONFIRM.

2. Open the door.

3. Remove the basis basket.

4. Unscrew the screw cap of the salt container anti-clockwise.

5. Place the filling funnel for the regenerating salt on the opening and
fill the salt container.

24
 5 First steps

6. Remove the filling funnel and any excess salt residue from the
washing chamber.

NOTICE
The salt has a corrosive effect on stainless steel. Salt residue must be removed from the washing
chamber and the screw cap of the salt container be closed tightly to protect the instruments and the
device.
n Salt residue on the sealing ring leads to leaks. Ensure that the sealing ring is clean before screwing on the
screw cap.

7. Screw the screw cap of the salt container tight.

8. Insert the basis basket.

9. Start the “Rinsing” program without (instrument) load.

Regenerating the water softening unit

The internal water softening unit regenerates automatically in certain intervals. The program run time is extended by a
number of minutes. You can regenerate the water softening unit manually after e.g. having filled it with salt without a
warning having previously been issued.
u To do so, start the “Regeneration” program.

Metering process agents

The concentration of the process agents is set once during the initial device setup performed by the services technician
(see technical manual). During a program run, the preset concentration of the relevant process agents is metered auto-
matically.

25
 5 First steps

Holding process agents ready

Video-Tutorial
See also “Replacing Process Agents”.

CAUTION
Danger of chemical burns!
Inappropriate handling of the process agents can lead to chemical burns and injury to health.
n Comply with the information from the manufacturer of the process agents.
n In the case of damage, every type of liquids (e.g. in the drawer, in the device floor trough or liquid issued
from the device) could potentially contain aggressive process agents.
n Protect your eyes, hands, clothing and all surfaces from contact with the process agents.

Note the following:

n Comply with the usage instructions, see Process agents [} page 10].
n Before commissioning or after a container exchange, you must bleed the metering system, see Removing air from
the metering system [} page 28].
n The }process agents may not be allowed to mix when changing the product. Place the suction lances in a container
with water and start the “Air removal” program.
The absence or insufficient filling level of a process agent will trigger the display of the corresponding message. In this
case you must replace or refill the process agents container.

Containers for process agents

Every process agent has its own container and a suction lance with screw-on lid:
▪ }Cleaning agent: 5 l container with a blue suction lance screw-on lid
▪ }Neutraliser: 5 l container with a red suction lance screw-on lid
▪ }Rinse aid: 1 l container with a black suction lance screw-on lid

u Place the container in the drawer in accordance with the process

agent assignment. A container can only be closed correctly if the
colour of the process agent matches that of the suction lance screw-
on lid.

26
 5 First steps

Replacing the containers for cleaning agent and neutraliser

1. Unscrew the suction lance from the container and place it in the
suction lance bracket.

2. Place the new container in the process agents drawer and screw
on the suction lance.
Ê The screw-on lid of the suction lance points forwards.
3. Remove the air from the metering system, see Removing air from
the metering system [} page 28].

Refilling rinse aid

WARNING
When }reprocessing ophthalmologic instruments }rinse aid may not be used, see Reprocessing
ophthalmological instruments [} page 31].

PLEASE NOTE
A streaky instrument surface could be caused by too much rinse aid.

Proceed as follows to fill an empty container with rinse aid:

1. Unscrew the suction lance from the container and place it in the
bracket behind it.

27
 5 First steps

2. Transfer the rinse aid from the original packaging into the MELAG
container.
Ê Fill the container with rinse aid ¾ full, otherwise the rinse aid
will overflow during insertion of the suction lance.
3. Screw the suction lance onto the container.

4. Remove the air from the metering system, see Removing air from
the metering system [} page 28].

Removing air from the metering system

Air must be removed from the metering system during commissioning or after removal of the suction lances. The “Air
removal” function removes all air pockets from the hoses and ensures good metering.
The rinse aid suction lance not used for ophthalmic instruments must be inserted head-first in the suction lance bracket
during the running of the “Air removal” program.
The “Air removal” program must be started after removing the suction lances or before the first reprocessing program.

1. If necessary, place the suction lance of the unused rinse aid head-
first in the suction lance bracket.

2. Repeatedly press FORWARDS/BACK until the “Air removal” program

is displayed.

3. Press START to start the “Air removal” program.

28
 6 Cleaning and disinfection

6 Cleaning and disinfection

Type of load
When loading the device, observe the user manual Accessories for MELAtherm. Only use the loading pattern specified
and approved within the scope of the validation.
This device can clean and disinfect max. 10 kg of the following type of }load:
▪ massive instruments
▪ hollow-body instruments e.g. aspirator tips, which are fixed to injector nozzles or
▪ transmission instruments e.g. handpieces and contra angles by using the adapter
Further accessories may be required when reprocessing ophthalmological instruments (not available from MELAG).
The operator is responsible for validating the procedure in combination with special load accessories. It is especially
important that feed lines to hollow-body instruments are maintained without kinking and as short as possible.

Wet/dry storage

Video tutorial
See also “Preparation of Instruments”.

n Store used instruments in a dry place. Ensure that they are stored protected from light and heat. Keep the storage
duration as short as possible, according to AKI maximum 6 hours.
n Instruments which present organic residue (e.g. blood) after patient treatment could benefit from pre-soaking in a
suitable treatment solution. Check that the process agent chosen for prior soaking is compatible with the washer-
disinfector }process agents. Otherwise, choose dry storage.
n If you perform pre-soaking, rinse the instruments thoroughly with running water before }reprocessing in the washer-
disinfector to prevent the solution from entering the device.
n Instruments may not be soaked overnight in water. Soaking in demineralised/distilled water is also associated with
damage connected with treatment residue (blood etc.).

Preparation and pre-cleaning

n If instruments are to be subject to manual preparation for cleaning, ensure that no media or tools/resources are
deployed which could damage their surface. Never use any aggressive cleaning agents, wire or brass wire brushes
or metal scourers. Information regarding correct instrument reprocessing is available from your instrument
manufacturer.
n Remove water-insoluble treatment substances (e.g. dental cement, root canal disinfectants, alginates or silicones)
directly after use by manual cleaning. Consult the product data sheets of the treatment substances.
n Other substances can also necessitate manual pre-cleaning. These include ultrasound gels and other auxiliary
substances.
n Check hollow bodies (transmission instruments, cannulas, etc.) for free passage. Observe the department-specific
instructions in this manual.
n Disassemble dismountable instruments for reprocessing according to the manufacturer's instructions.
n Remove corroded or defective instruments. Crusted instruments must be subject to a basic cleaning or repair.
n }KRINKO/}BfArM (2012) recommend that instruments of the risk class “Semi-critical B” and “Critical B” are
subjected to pre-cleaning directly after use.
n The complete cleaning and disinfection of surgical aspirators requires manual pre-cleaning of the interior lumen.
Subsequent suction (e.g. using the dental unit) of a minimum of 200 ml water through the surgical aspirator
immediately or 10 min (at the latest) after treatment will achieve sufficient pre-cleaning. A comparable or more
intensive pre-cleaning is permissible.

29
 6 Cleaning and disinfection

Arranging the load

NOTICE
Some brands are only authorised for thermal disinfection after a specific year of manufacture.
n Only reprocess instruments designed by their manufacturer for automatic reprocessing in a washer-
disinfector.
n Comply with the information from the relevant instrument manufacturer.

In order to arrange the }load, the basis basket including insert racks, instrument baskets, wash trays and/or sieve cas-
settes must be used. The basis basket with an injector rail is available for }reprocessing hollow-body instruments.
Further accessories and their user instructions such as insert racks for wash trays, sieve cassettes and instrument bas-
kets etc. are listed in the user manual Accessories for MELAtherm.
Note the following:
n Empty all residual liquids from containers before arranging them in the device. Rinse away any liquids (e.g.
disinfectant solutions) thoroughly.
n Never place any individual instruments directly in the basis basket. Use baskets or trays to this end.
n Ensure that instruments do not protrude from the sides of the instrument basket or the basis basket. Protruding
instruments can damage the seal and the surface of the door or the side walls of the washing chamber. The
instruments can break.
n Place hollow-body instruments in the device in such a way as to ensure safe rinsing. If necessary, use the
accessories developed especially for reprocessing hollow-body instruments such as injector nozzles, Luer
connections, adapters etc. See user manual Accessories for MELAtherm.
n Avoid blockages of the rinse arm from instruments protruding upwards or downwards. The rinse arms must be able
to rotate freely.
n Avoid unwashed areas. A good cleaning outcome depends on the correct arrangement of the instruments.
n Arrange all containers such as kidney dishes etc. with their opening pointing downwards.
n Place components with openings or compressions at an angle, so that the water can run off them.
n Only use thermostable instruments approved by their manufacturer for reprocessing.

Reprocessing hollow-body instruments

WARNING
Danger of contamination from insufficient disinfection
Residue on the hollow-body instruments can hinder water pass through and thus impair their disinfection.
n Check the hollow-body instrument for free passage before reprocessing.

WARNING
Danger of contamination from insufficient disinfection
All openings must be occupied when using multi-way distributors or the injector rail. Only then can a correct
function be guaranteed.
n Seal non-used openings.

WARNING
Danger of contamination from insufficient disinfection
Use a filter insert for hollow-body instruments with an inside diameter ≤ 0.8 mm.
n Do not use the metal filter disc or the Cleanfinity filter in the ophthalmic area.
n Instead, use the ceramic filter disc or the plastic central filter.

30
 6 Cleaning and disinfection

Note the following:

n Comply with the specifications from the instrument manufacturer.
n Rinse all hollow-body instruments after use with patients or before automatic reprocessing.
n Reprocess only those hollow-body instruments which guarantee sufficient and reproducible rinsing. Remove
instruments with a recognisably reduced throughflow.
n Use only MELAG adapters to }reprocess hollow-body instruments on the injector rail. The suitability of a hollow-body
instrument for the respective adapters and the sufficient rinsing can only be proven by validation.
n Check the connection between the adapter and the hollow-body instrument for stability both before and after
reprocessing. Should the connection work loose after reprocessing, the instruments must be reprocessed again.
n Comply with the cleaning and replacement intervals when using filter inserts. The cleaning and replacement intervals
can be found in the user manual Accessories for MELAtherm.
n When reprocessing dental and ophthalmologic transmission instrument, observe and comply with the special
reprocessing instructions in Reprocessing dental transmission instruments [} page 31] and Reprocessing
ophthalmological instruments [} page 31].
Rule for use of filters or filter discs:
Diameter of the inner lumen Application of a filter
≤ 0.8 mm Filter required, e.g. triple distributor incl. ceramic filter disc (art. no. ME73903)
> 0.8 mm No filter required, direct connection of the adapter to the injector rail possible

Reprocessing dental transmission instruments

Note the following:
n Comply with the specifications from the instrument manufacturer.
n The exterior surfaces of the handpieces and contra angles should be free of all water-insoluble residue e.g. dental
cement.
n The air and spray channels must be entirely clear.
n Prevent soiling from drying, especially on and in the handpieces and contra angles.
n Use a citric acid based }neutraliser for the }reprocessing of dental transmission instruments.
n Dry the hollow-body instruments after reprocessing using medical compressed air.

Care of the instruments and adapters

Immediately after successful cleaning and disinfection, re-dry the spray, air and water channels using medical com-
pressed air. Carry out maintenance with suitable care products and oils.
Check the adapters for transmission instruments at regular intervals for possible soiling. If necessary, rinse the individual
parts of the adapters under running water. Rub the silicone inserts of the universal adapters with a damp, non-fuzzing
cloth.

Reprocessing ophthalmological instruments

Comply with national recommendations for the cleaning of medical products under the aspect of decontamination of
infectious prion proteins (CJD).

WARNING
Danger of contamination from biological interactions.
Devices used to reprocess ophthalmologic instruments may only be used exclusively for this purpose.
n Do not reprocess any instruments used in retinal surgery (coming into contact with retinal tissue, subretinal
fluid and the optical nerve).
n Fit these devices with a suitable filter system e.g the ceramic filter disc or the plastic central filter.
n Do not use the metal filter disc or the Cleanfinity filter for the reprocessing of ophthalmological instruments.

31
 6 Cleaning and disinfection

WARNING
Do not use }rinse aid for reprocessing ophthalmic instruments!

1. If present, remove the rinse aid container from the process agents
drawer and hang the black suction lance in the suction lance bracket
so that the screw-on lid is positioned at the top.

2. The process agent hoses only need to be placed head-first in the

suction lance bracket if the metering hoses are to be bled, see
Removing air from the metering system [} page 28].

PLEASE NOTE
Use demineralised water to reprocess ophthalmological instruments.
n To this end, e.g. connect a mixed-bed resin cartridge.

Suitable program
Reprocess ophthalmological instruments in the Ophthalmo-Program. Only this program enables monitoring of the
water }conductivity during the disinfection phase; this ensures a residual conductivity which is uncritical for applications
on both the eye.
Note the following:
n Comply with the specifications from the instrument manufacturer.
n Cleaning should be performed with a mildly-alkaline }cleaning agent. Neutralisation should be performed with a citric
acid based }neutraliser.
n Rinse all hollow-body instruments with }DI water after use with patients or before automatic reprocessing.
n Reprocess only those hollow-body instruments which guarantee sufficient and reproducible rinsing. Remove
instruments with a recognisably reduced throughflow.
n Connect all hollow bodies properly with the adapters provided.
n Ensure that plugs and/or cables from Phaco handpieces are not able to slip through the basis basket, otherwise the
rinse arm can become blocked.
n Try to prevent soiling from drying or encrusting on and in the instruments.
n Dry the ophthalmological instruments after reprocessing using medical compressed air.
n When using rinsing systems, seal individual outlets which are not connected with suitable accessories.

Instrument care
Comply with the manufacturer's instructions regarding the care and maintenance of the instruments / the load accesso-
ries.

32
 6 Cleaning and disinfection

Routine check
Perform a routine check of the }pH value after reprocessing of the hollow-body instruments.
1. Blow through the hollow-body instrument with medical compressed air onto indicator paper (e.g. from Macherey-
Nagel: PEHANON pH 4.0-9.0). The measurement accuracy must amount to or exceed 0.5.
2. Compare the value displayed on the indicator paper with the pH value of the final rinse water from the previous
performance qualification.
3. Should you discover any deviations, contact the customer services.

Overview of programs
Select the program according to the level of soiling of the }load. Comply with the specifications from the validation.
Use the Universal-Program predominantly in everyday general cleaning and disinfection. The Quick-Program is designed
for lightly soiled instruments.
The following table lists the correct program for each load.
Reprocessing Symbol Nature of the instruments / degree of soiling Operating time*)
program without drying time
DTA DTB
Universal-Program1) ▪ For normal to heavily soiled instruments 42 min 63 min

Quick-Program ▪ For unsoiled or lightly soiled instruments 37 min 57 min

Intensive-Program ▪ For especially heavily soiled instruments 54 min 67 min

▪ Like the Universal-Program, but with a longer cleaning
time
Ophthalmo-Program ▪ For ophthalmology instruments 43 min 63 min
▪ Like the Universal-Program, but with a longer cleaning
time, double intermediate rinsing without rinse aid
*) The specified operating times are average values and apply to the recommended running water pressure at a cold
water temperature of 15 °C.

Additional program Symbol Application Operating time*)

Rinsing ▪ For rinsing strongly soiled instruments (e.g. blood) 3 min
A disinfection program must then be started.
▪ To rinse out the washing chamber after filling salt;
without process agents, no disinfection
Emptying ▪ Pumping out residual water from the washing chamber 1 min

Conductivity ▪ For measuring the conductivity of the DI water 2 min

measurement DI

Air removal ▪ After filling / changing the process agents, i.e. product 5 min
change etc.
▪ With decommissioning and commissioning
Regeneration ▪ Regenerating the internal water softening unit 8 min

Time metering 60 s ▪ Only for service technicians --

*) The specified operating times are average values and apply to the recommended running water pressure at a cold
water temperature of 15 °C.

1)
In accordance with the A0 concept from EN ISO 15883-1, thermal disinfection is performed with 90 °C (+ 5 °C, - 0 °C) and an applica-
tion time of 5 min (min. A0-3000).

33
 6 Cleaning and disinfection

Selecting, starting and monitoring the program

Ensure compliance with the following prerequisites in order to secure the optimal rinsing performance before every pro-
gram start:
n The process agents containers are sufficiently full.
n The injector rail nozzles / adapters are clean.
n The rinse arms can be turned freely.
n The load is arranged correctly.
n Baskets and inserts are inserted correctly.

Selecting and starting a program

Video tutorial
See also “Selecting Program”.

1. Select a program in accordance with the program overview

[} page 33].

2. Navigate to the desired program with FORWARDS/BACK.

Ê The display shows the program names and the type of

reprocessing for which the program is suitable.
3. Press START to start the selected program.

Monitoring the program run on the computer

You can monitor the current progress of a program run on every computer in the (practice) network. To do so, an IP
address must be issued for the device and it must be incorporated in the (practice) network.
1. Open a web browser window in the practice PC (Mozilla Firefox or
Internet Explorer / Microsoft Edge is recommended).

2. Enter the device IP address in the address bar of the web browser, Address bar of
e. g. 192.168.70.206 and confirm with Enter. web server

Program
run

Ê The program run and the device information such as e. g. serial number and device software version will be
displayed.

34
 6 Cleaning and disinfection

Manual program abort

NOTICE
Aborting a current program by deactivation at the power switch may cause damage at the device.
n Never abort a program by switching off at the power switch.

Aborting the program during drying

WARNING
Nucleation because of poor drying.
If a program is aborted during drying, residual dampness can remain on the instruments.
n Only abort a current program in exceptional reasons.
n Dry the instruments manually.

CAUTION
Danger of burns from hot instruments and surfaces.
The instruments and chamber can remain hot even after the device has been switched off.
n Allow the device to cool before removing the instruments.
n Wear suitable protective gloves.

If you abort a program during drying, the program is considered as having been ended successfully.
Aborting the program during drying:

1. Wait until Partial cycle: Drying is displayed.

2. Press CANCEL and confirm the abort with YES.

3. Press UNLOCK to open the door.

35
 6 Cleaning and disinfection

Aborting the program before the start of drying

WARNING
Danger of contamination through program abort!
Aborting a program before the drying phase begins means that the load is classed as not having been
disinfected. This endangers the health of the patient and the practice team.

CAUTION
Danger of burns from hot instruments and surfaces.
The instruments and chamber can remain hot even after the device has been switched off.
n Allow the device to cool before removing the instruments.
n Wear suitable protective gloves.

If you want to abort a running program before drying starts, press CANCEL and follow the instructions on the display.

Authentication and batch approval

Authentication
Authentication is used for personalised removal of the }load from the device with or without subsequent batch approval.
If authentication has been activated and the reprocessing program completed successfully, you will automatically be
asked to enter your user PIN. Your user ID is shown in the log.

Batch approval
The batch approval following program end is used to assess and log the outcome of the }reprocessing (batch approved/
not approved). The }batch is assessed by the user on the basis of various criteria (e.g. degree of cleaning and drying,
position of the load, etc.).
In order to be able to carry out batch approval (with or without authentication), this must be activated. You will be auto-
matically requested to perform batch approval after successful completion of the reprocessing program.

Batch assessment and approval with authentication

Once the reprocessing program has been completed successfully, you will automatically be asked to assess the batch
and provide it with approval.
The following must be fulfilled or present:
ü Authentication is activated, see Authentication [} page 62].
ü Batch approval is activated, see Batch approval [} page 63].
ü The reprocessing program has been completed successfully.

1. Press UNLOCK.

Ê The User PIN view is displayed.

36
 6 Cleaning and disinfection

2. Enter your four-digit user PIN and press CONFIRM.

Ê The door is unlocked.

Ê The Approve batch view is displayed.
3. Press DETAILS for information for the batch approval assessment
criteria.

4. Press FORWARDS and read all the assessment criteria carefully.

Check the reprocessed batch using the assessment criteria outlined.

5. Press LEAVE to switch to Approve batch.

6. Press YES if the assessment criteria are met.

Press NO if the assessment criteria are not met.

Ê The log will show User ID: ## and Batch approved: YES or NO.

Batch assessment and approval without authentication

Batch assessment without authentication can only be performed if batch approval is activated and authentication is deac-
tivated. If this is the case, you will not be prompted to enter your user PIN before batch assessment.
The following must be fulfilled or present:
ü Authentication is deactivated, see Authentication [} page 62].
ü Batch approval is activated, see Batch approval [} page 63].
ü The reprocessing program has been completed successfully.

1. Press UNLOCK.

Ê The Approve batch view is displayed.

2. Press DETAILS for information for the batch approval assessment

criteria.

37
 6 Cleaning and disinfection

3. Press FORWARDS and read all the assessment criteria carefully.

Check the reprocessed batch using the assessment criteria outlined.

4. Press LEAVE to switch to Approve batch.

5. Press YES if the assessment criteria are met.

Press NO if the assessment criteria are not met.

Ê The log shows User ID: DEACTIVATED and Batch approved: YES or NO.

Authentication without batch approval

If an automatically documented batch assessment and approval is not desired, then there is the option of an authenticat-
ed removal of the load. In this case, the fact of the reprocessed load having been removed by an authenticated user will
be documented.
The following must be fulfilled or present:
ü Authentication is activated, see Authentication [} page 62].
ü Batch approval is deactivated, see Batch approval [} page 63].
ü The reprocessing program has been completed successfully.

1. Press UNLOCK.

Ê The User PIN view is displayed.

2. Enter your four-digit user PIN and press CONFIRM.

Ê The door is unlocked and can be opened.

Ê The log shows User ID: ## and Batch approved: DEACTIVATED.

38
 6 Cleaning and disinfection

Skip authentication
If both batch approval and authentication have been activated, you will automatically be requested to assess the batch
and provide it with approval after the reprocessing program has been completed successfully. You have the option to
skip the authentication and continue in the process.

PLEASE NOTE
Skipping authentication means that the batch will automatically be evaluated as not having been
approved.
You can document the assessment separately and continue in the prescribed practice process.

The following must be fulfilled or present:

ü Authentication is activated, see Authentication [} page 62].
ü Batch approval is activated, see Batch approval [} page 63].
ü The reprocessing program has been completed successfully.

1. Press UNLOCK.

Ê The User PIN view is displayed.

2. Press SKIP.

Ê The confirmation prompt Skip authentication is

displayed.

3. Press YES.

Ê The door is unlocked.

Ê The Door unlocked view is displayed.
4. Open the door.

Ê The log shows User ID: Skipped and Batch approved: NO.

39
 6 Cleaning and disinfection

Removing the load after program end

CAUTION
Danger of burns from hot instruments and surfaces.
The instruments and chamber can remain hot even after the device has been switched off.
n Allow the device to cool before removing the instruments.
n Wear suitable protective gloves.

PLEASE NOTE
Open the door immediately after the end of the program to prevent the accretion of condensation.
Do not leave any instruments in the washing chamber overnight.

The display message indicates whether and when a program has been completed successfully. The display shows the
last batch number and the total batch counter after every program end or the end of a program abort.

1. Press UNLOCK and open the door.

2. Remove the load whilst complying with all the hygiene and
working safety regulations.

3. Check whether the load has been cleaned successfully.

40
 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 parame-
ters 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.
As delivered, the CF card is set as the output medium. Setting a different output medium or activating the internal log
memory is outlined under Settings [} page 48].

Capacity of the internal log memory

The device is equipped with an internal log memory. This saves all the data regarding the program automatically. The
capacity of the internal log memory is sufficient for 15-20 logs. If the internal log memory is full, the display will show The
internal log memory is full. Please output all logs via log output in the main menu. If this
warning is issued, provide the specified output medium (see Settings [} page 48]) and output the affected log (see Log
settings [} page 49]). If the program is continued, the logs are deleted automatically; the last ten saved logs remain in
the log memory.
MELAG recommends outputting logs immediately.

Output media
You can output the logs of the finished programs via the following output media:
▪ CF card
▪ A computer via the (practice) network (LAN)
▪ MELAprint 42/44 log printer with network adapter
The output media can be combined in any fashion. Thus it is possible both to save logs on the CF card (included in the
scope of delivery) and also to print them on the log printer.

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

Using the CF card as an output medium

Video tutorial
See also “Batch Documentation”.

Inserting the CF card

The card slot for the }CF card is located behind the cover cap on the right, adjacent to the door below the power switch.
When inserting the CF card in the slot, ensure that it is aligned correctly.
1. Open the CF card cover cap.

41
 7 Logging

2. Insert the CF card in the slot with the contacts at the front. The
MELAG lettering on the CF card points towards the LED.

3. Slide the CF card in the card slot until it clicks. Do not use force.
When the CF card has been placed correctly, the red LED will
illuminate shortly.

4. Close the cover cap.

Removing the CF card

NOTICE
Premature removal of the CF card from the card slot or its inappropriate handling can result in data
loss, damage to the CF card or the device.
n Never remove the CF card from the slot whilst it is being written or read.

1. Open the CF card cover cap.

2. Press the ejection button and remove the CF card.
3. Close the cover cap.

Using the computer as an output medium

You can either connect a computer directly to the device or via a network if the following conditions are fulfilled:
n The computer is fitted with a network card with a RJ45 bushing (LAN).
n An FTP server or an FTP service is installed on the computer (when the log is issued via FTP).
n A suitable program, e.g. MELAtrace/MELAview, is installed (when the log is issued via TCP).
Working in the Settings menu, you can perform or change network settings, see Log settings [} page 49].

Outputting logs immediately and automatically

When the device is delivered, the CF card is set as an output medium in the Settings menu and thus the automatic
log output at the end of a program (immediate output = yes) is thus activated. Log output on multiply activated media is
performed successively. You can select or add an alternative output medium for automatic log output, see Log settings
[} page 49].

Text logs
The following requirements must be fulfilled in order to output text logs immediately after the end of a program:
n In the Settings > Log settings > Immediate output is set to yes.
n In the Settings > Log settings a minimum of one output medium has been selected and Immediate
output has been set to yes.
n The activated output medium is available (e.g. the MELAprint 42/44 log printer or CF card).

42
 7 Logging

Graphic logs (optional)

The following requirements must be fulfilled in order to record graphic logs:
n In the Settings > Log settings > Graphic logs at least one output medium is set to yes.
n At least one of the output media selected for graphic logs corresponds to an output medium for the text log. This
means that at least the computer or the CF card must be activated as an output medium for both log types.
n The selected output medium has been connected.

PLEASE NOTE
Graphic logs cannot be saved in the internal log memory and cannot be outputted via the log printer
MELAprint 42/44.
n Save the graphic log on the CF card or the computer.

Note the following:

n The text log is issued on the selected output medium after the end of the program run. At the same time, this text log
is saved in the internal log memory and marked as output.
n If multiple output media have been activated, all activated output media must be connected to the device. Otherwise,
the text logs are saved in the internal memory and are classed as not output.
n If the internal log memory is almost full, the device will register all the text logs which are classed as not output. The
warning message 386 appears after the program start. You can acknowledge this message by pressing CONFIRM
and continue the program run.
n With warning message 372, you must manually output logs that have not yet been output. Only then is a program
start possible. The log memory is deleted automatically after manual issue; the last ten logs remain in the log
memory. The manual outputting of logs is outlines under Subsequent log output [} page 43].

Subsequent log output

The Log output menu provides the option of issuing logs subsequently and independently of the point of the program
end.
1. From the main menu, press FORWARDS/BACK until the Log
output menu is displayed.

2. Press CONFIRM to open the menu.

3. Press FORWARDS until the desired output medium (CF card,

MELAprint, Computer, automatic) is displayed.

If you want to apply the settings from the Log settings menu,
select the output medium automatic.

4. Press CONFIRM to select the displayed output medium.

5. Press FORWARDS until the desired log type, e.g. Last log, All
malfunction logs, is displayed.

6. Press OUTPUT to start the log output.

43
 7 Logging

Deleting the saved logs

1. Save the logs on an output medium before deleting them.

2. From the main menu, press FORWARDS/BACK until the Log

output menu is displayed.

3. Press CONFIRM to open the menu.

4. Press CONFIRM again.

5. If necessary, press FORWARDS/BACK until All logs is

displayed.

6. In the context menu, press DELETE.

Ê The confirmation prompt is displayed Delete all

internal log memory logs?

7. Press YES to delete all logs.

Determining the format for the program logs

The log format enables you to determine which of the data saved in the log memory is to be outputted. You can choose
between the formats 0, 1 and 2. The log format 2 is the standard format. Working in the Settings menu, you can
select the log format for the program log (see Log settings [} page 49]).
You can choose between the following format:

Format Description
0 Short log:
Only the log header is outputted.
1 Short log with program steps:
The log header and the program steps are outputted.
2 Standard log:
In addition to the log header and the program steps, a legend is displayed explaining the individual
program steps.
Logs outputted via the MELAprint log printer always contain a legend row located under the row to
which it refers.

44
 7 Logging

Log types
In addition to logs for successfully completed programs, there are other types of log. These can also be outputted via the
selection list in the Log output menu. You can identify the log type by the ending of its file name.

Ending Stands for Explanation

.PRO Program log Log of a successfully completed program
.GPD Graphic log A log in which the processes are recorded graphically
.STR Malfunction log Log of an aborted program
.STB Malfunction in Log with malfunctions without a program having run
standby
.LOG System log List of all the malfunctions and changes to the system in order of time (log book)
.STA Status log Summary of all the important settings and system states (counter, measured values
etc.) + a list of all process-relevant parameters (VRP)
.LEG Legend log Contains all step abbreviations used in the program log
.DEM Demo log Log of a program simulated as completed in DEMO mode (only for presentation
purposes)
.DES Demo malfunction Log of a program simulated as interrupted (presentation)

45
 7 Logging

Example of a program log for a successfully completed program

--------------------------------------- ----------------------------------------
10 MELAG MELAtherm 10 Evolution DTA 10 Log header: Device name
--------------------------------------- ----------------------------------------
15 Program : Universal-Program 15 Program name
20 TARGET °C min 20 Column heading for 21-28
21 Pre-clean: 22.0 03:30 21 Nominal value temperature and holding time
23 Cleaning : 55.0 10:00 23 Nominal value temperature and holding time
28 Desinfect: 90.0 05:00 28 Nominal value temperature and holding time
30 Date : 19.07.2019 30 Date
35 Batch : Day:10 Total:00071 35 Daily and total batch counter
36 User ID : 1 36 User ID and authentication
37 Batch approved: Yes 37 Status batch approval
===== =====
40 Program successfully completed 40 Control message
====== ======
50 ACTUAL °C +/- K min 50 Column heading for 51-58
51 Pre-clean: 26.9 +1.0/-1.0 03:30 51 Nom. value temp. range and holding time
53 Cleaning : 57.5 +0.3/-0.2 10:00 53 Nom. value temp. range and holding time
58 Desinfect: 92.2 +0.2/-0.2 05:00 4152 58 Nominal value temp. conditions, A0 value
----- ------
60 Conduct. : 7.2 (---) µS/cm 60 DI water conductivity for final rinse in supply line
65 Start : 12:27:59 (---) Final conductivity in the pump sump (only in the
70 End time : 13:35:26 (67:27 min) Ophthlamo-Program)
====== 65 Time at program start
80 SN:201910E-DTA0104 70 Time at program end
====== ======
81 Firmware : V3.013 18.07.2019 80 Device serial number
82 Parameter: V3.010 26.06.2019 ======
83 BO : V3.524 24.05.2019 81 Installed firmware version
85 Release : V3.0.15 25.06.2019 82 Installed parameter version
---------------------------------------- 83 Installed user interface
Step Start End Time °C ml mbar 85 Release version
--> Process start ----------------------------------------
... Step = Program step
--> Pre-cleaning Start = Time at start of partial cycle
... Ende = Time at end of partial cycle
--> Cleaning Time = Time (mm:ss), required by a partial cycle
...
°C = Temperature of the rinse liquor in the washing
--> Neutralization
chamber in degrees Celsius
...
ml = Quantity of cold water and DI water, respective
--> Intermediate rinsing
process agent consumed during a program step
...
mbar = Rinse pressure
--> Disinfection
92 = Up to five warnings
...
95 = Event number upon program abort
--> Drying
...
--> Process end
...
--------------------------------------- ----------------------------------------
>> Never change code in following row << Proof of authenticity:
0100002C1B4802BE0306064C0B3C0AD0130D9610 Must never be changed; permits inference that the data
07BD3EFECA15229618881B257A98850427217323 was created on a MELAG device and has not been
930815C1C892292E3965C071864442576F5F38AC changed.
648A82A3945A3D404141440157A94648AE494AEC
>> Proof of authenticity batch log <<
----------------------------------------
---------------------------------------
Sensor measurement values are displayed following a
Voltage max/min: 225/214
malfunction. The values are helpful for a service
CW:33.0 DI: 7.0
technician.
0.0 0.0 -0.00 0.0
--et1---et2----eps----etu----------END

46
 7 Logging

Finding the logs

PLEASE NOTE
Do not rename the directories, otherwise logs will be stored in both the renamed directory as well as
the device directory which the device generates automatically.

All memory media (CF card or computer) contain a directory with the encoded serial number of the device concerned
following log output. The directory name consists of five characters identical with the first five characters of every log, e.g.
CR0ZH. This directory contains sub-directories with the month of log generation e.g. 01_2020 for January 2020. This
contains all logs generated by the device in this month. The device directory is entered in the main directory on the CF
card.
MELAtherm10

CR0ZH

01_2020

The device checks the memory medium after every type of log output (immediate output after a completed cycle or the
transfer of multiple logs simultaneously). Should a directory not exist, it automatically creates a directory for the device
and the month. If logs are outputted on the same memory medium more than once, a duplicate directory will be created
under the device directory in which these logs will be saved only once.
Given direct log transfer to a computer, set the memory location in the program (FCP, FTP) used on your computer.

47
 8 Settings

8 Settings

Settings menu
In the Settings menu, parameters such as date, time, display brightness, etc. can be set.
The general procedure for making settings is described below.

Opening the menu

1. From the main menu, press FORWARDS/BACK, until the Settings

menu is displayed.

2. Press CONFIRM to open the Settings menu.

Making settings
The following must be fulfilled or present:
ü The desired submenu is opened.
1. Press EDIT in the menu.
Ê The parameter appears in light blue. You can make or change settings.
2. Press CONFIRM to accept the setting.
Ê The parameter appears in dark blue.
Ê The setting is completed.

PLEASE NOTE
Not all settings made are automatically saved immediately, but only when you exit the Settings
menu.
Some settings require a system restart. The restart is carried out automatically after the settings have been
saved.

Exiting the menu

1. Press LEAVE in the menu.

2. Press YES to exit the Settings menu.

3. Press YES to save the settings.

Press NO to discard the settings.

48
 8 Settings

Log settings
You can define settings for automatic logging in the Log settings submenu. Detailed information regarding logging is
provided in chapter Logging [} page 41].

1. From the Settings menu, press FORWARDS/BACK until the Log

settings submenu is displayed.

2. Press CONFIRM to open the submenu.

Selecting the output media

In the Log settings submenu, you have the option to select the output media for automatic logging.
The following example describes how to select a CF card as output medium. The selection of another or further output
medium is done according to the same procedure.
The following must be fulfilled or present:
ü The Settings > Log settings menu is open.

1. Press FORWARDS/BACK until CF card is displayed.

2. The parameter yes indicates that logs are automatically saved on

the CF card.

Press EDIT if the parameter is to be changed.

3. Press FORWARDS/BACK to switch between yes and no.

4. Press CONFIRM to accept the changes.

Immediate output
If you have specified an output medium for logging, you must also activate the immediate output. If the immediate output
is not active, none of the previously determined output media is used for automatic logging.
The following must be fulfilled or present:
ü The Settings > Log settings menu is open.

1. Press FORWARDS/BACK until Immediate output is displayed.

49
 8 Settings

2. Press EDIT if the parameter is to be changed.

3. Press FORWARDS/BACK to switch between yes and no.

4. Press CONFIRM to accept the changes.

Determining log format

The following must be fulfilled or present:
ü The Settings > Log settings menu is open.

1. Press FORWARDS/BACK until Log format is displayed.

2. Press EDIT if the parameter is to be changed.

3. Press FORWARDS/BACK to switch between format 0, 1 and 2.

4. Press CONFIRM to accept the changes.

Detailed information regarding the log formats 0, 1 and 2 is provided in Determining the format for the program logs
[} page 44].

50
 8 Settings

Setting the network

NOTICE
The setting up in the (practice) network will require in-depth understanding of the network technology.
Handling errors of IP addresses can result in malfunctions and data loss in your user network.
n IP addresses may only be set by the (practice) network system administrator.

The network settings for logging can be changed in the Network submenu.
The following must be fulfilled or present:
ü The Settings > Log settings menu is open.

1. Press FORWARDS/BACK until Network is displayed.

2. Press CONFIRM.

Ê Settings can be made for MELAtherm IP, connection type, FTP password, TCP port, computer IP, MELAprint-EDM
IP, gateway IP and subnet mask.

MELAtherm IP, computer IP, MELAprint-EDM IP, gateway IP, subnet mask
The following describes how to set the MELAtherm IP. The other parameters are set according to the same procedure.
The following must be fulfilled or present:
ü The Settings > Log settings > Network menu is open.

1. Press FORWARDS/BACK until MELAtherm-IP is displayed.

2. Press CONFIRM if a change is to be made.

3. Press FORWARDS/BACK to select the digit you want to change. The

open arrow to the left of the digit indicates the current selection.

4. Press EDIT.

5. Press FORWARDS/BACK to change the digit.

51
 8 Settings

PLEASE NOTE
Holding the FORWARDS or BACK button pressed accelerates the increase or decrease.

6. Press CONFIRM to accept the changes.

7. Repeat step 3 to 6 in order to edit more digits.

Type of connection
Working in the Type of connection window, you can choose between an FTP and an FTP/IP connection.
The following must be fulfilled or present:
ü The Settings > Log settings > Network menu is open.

1. Press FORWARDS/BACK until Type of connection is displayed.

2. Press EDIT.

3. Press FORWARDS/BACK to switch between 0 (FTP) and 1 (TCP/IP).

4. Press CONFIRM to accept the changes.

FTP password, TCP port

The following describes how to set the FTP password. The setting of the TCP port can be done the same fashion.
The following must be fulfilled or present:
ü The Settings > Log settings > Network menu is open.

1. Press FORWARDS/BACK until FTP password is displayed.

52
 8 Settings

2. Press EDIT.

3. Press FORWARDS/BACK to change the parameter.

PLEASE NOTE
Holding the FORWARDS or BACK button pressed accelerates the increase or decrease.

4. Press CONFIRM to accept the changes.

PLEASE NOTE
If the device is integrated in the (practice) network via a TCP connection, you will require a suitable
program, e.g. MELAview/MELAtrace.

Outputting graphic logs

In the Graphic logs submenu, you have the option of selecting the output media for the automatic logging of graphic
logs.
The following describes how to set the CF card as the output medium. The selection of another or further output medium
is done according to the same procedure.
The following must be fulfilled or present:
ü The Settings > Log settings menu is open.

1. Press FORWARDS/BACK until Graphic logs is displayed.

2. Press CONFIRM to open the submenu.

Ê Settings can be made for the output medium CF card and

computer.

3. Press EDIT, to change the parameter CF card.

53
 8 Settings

4. Press FORWARDS/BACK to switch between yes and no.

5. Press CONFIRM to accept the changes.

Setting the date and time

Date and time of the device must be correctly set for proper batch documentation.

Setting the date

The following describes how to set the Day parameter. The Month and Year parameters are set according to the same
procedure.
The following must be fulfilled or present:
ü The Settings > Date menu is open.

1. Press CONFIRM to open the submenu.

2. Press EDIT.

3. Press FORWARDS/BACK to change the parameter.

4. Press CONFIRM to accept the changes.

Setting the time

The following describes how to set the Hour parameter. The Minute parameter is set according to the same procedure.
The following must be fulfilled or present:
ü The Settings > Time menu is open.

1. Press CONFIRM to open the submenu.

54
 8 Settings

2. Press EDIT.

3. Press FORWARDS/BACK to change the parameter.

4. Press CONFIRM to accept the changes.

Setting the display brightness

The following must be fulfilled or present:
ü The Settings > Display brightness menu is open.

1. Press EDIT.

2. Press FORWARDS/BACK to change the parameter. The colour bar

gives an impression of the colour contrast.

3. Press CONFIRM to accept the changes.

Setting the idle mode

The following must be fulfilled or present:
ü The Settings > Idle mode in min menu is open.

1. Press EDIT.

2. Press FORWARDS/BACK to change the parameter.

55
 8 Settings

3. Press CONFIRM to accept the changes.

Setting the volume of the signal tone

The following must be fulfilled or present:
ü The Settings > Signal tone volume menu is open.

1. Press EDIT.

2. Press FORWARDS/BACK to change the parameter.

3. Press CONFIRM to accept the changes.

Setting the volume of the key tone

The following must be fulfilled or present:
ü The Settings > Key tone volume menu is open.

1. Press EDIT.

2. Press FORWARDS/BACK to change the parameter.

3. Press CONFIRM to accept the changes.

56
 8 Settings

Connectivity
In the Connectivity submenu, you can connect the device to the MELAconnect app. You can use this app to monitor
instrument reprocessing performed on multiple devices in parallel and to access context-related troubleshooting assis-
tance.

Establishing a connection between the MELAG device and the MELAconnect app
The following must be fulfilled or present:
ü The MELAconnect app is installed on your mobile end device (e.g. smartphone, tablet).
ü The device is connected to the (practice) network, see Setting the network [} page 51].
ü The Settings > Connectivity menu is open.

1. Press CONFIRM.

Ê The QR code is displayed in the place of the symbol in the

main area of the display.
2. Open the MELAconnect app on your mobile device.

3. Scan the QR code using the MELAconnect app on your mobile end
device.

Ê The serial number and the IP address of your device are transmitted to the app.
Alternatively, you can enter the IP address of your device manually in the MELAconnect app. With manual entry of the IP
address: Owners of multiple MELAG devices of the identical type can differentiate between their devices by viewing seri-
al number on the display to check whether MELAconnect has been connected to the correct device.

Setting the language

The following must be fulfilled or present:
ü The Settings > Language menu is open.

1. Press EDIT.

2. Press FORWARDS/BACK to change the parameter.

3. Press CONFIRM to accept the changes.

57
 8 Settings

Setting the water supply

If the device is connected to a }DI water supply e.g. MELAdem 53/MELAdem 53 C or another water treatment unit, this
must be set on the device.
When the device is delivered, the water supply has been set to DI water yes.

PLEASE NOTE
This setting is performed by the service technician during device commissioning.

The following must be fulfilled or present:

ü The Settings > DI water menu is open.

1. Press EDIT.

2. Press FORWARDS/BACK to change the parameter.

3. Press CONFIRM to accept the changes.

Setting the water hardness

PLEASE NOTE
The service technician determines and sets the water hardness during device commissioning.

The following must be fulfilled or present:

ü The Settings > Water hardness in °dH menu is open.

1. Press EDIT.

2. Press FORWARDS/BACK to change the parameter.

3. Press CONFIRM to accept the changes.

58
 8 Settings

Administrative settings
Working in the Administration submenu, the administrator is able to assign user PINs to existing user IDs as well as
activate or deactivate the authentication and batch approval.

Logging in as an administrator
The following must be fulfilled or present:
ü The Settings > Administration menu is open.

1. Press CONFIRM.

2. Enter the admin PIN (factory-set admin PIN: 1000) and press
CONFIRM.

Ê Successful login will result in display of the User submenu. You are logged in as an administrator.

Logging out as an administrator

The following must be fulfilled or present:
ü You are logged in as an administrator.
ü The Settings > Administration menu is open.

1. In any view, press LEAVE until the confirmation prompt to exit the
settings is displayed.

2. Press YES to exit the settings.

3. Press YES or NO to save or discard the settings.

Ê The Settings menu appears. You are logged out as an administrator.

59
 8 Settings

User
In the Settings > Administration > User menu, 20 user IDs are preset. The administrator can assign and edit a
user PIN to each user ID. Every user PIN consists of four digits.

Creating and assigning a new user PIN

When the device is delivered, the user IDs 2 to 20 have not been assigned a PIN. The administrator can create a user
PIN for each of these IDs. User IDs without a user PIN are marked with a dash.

PLEASE NOTE
The PIN 1000 is reserved for the administrator and cannot be assigned to another user ID. This also
applies when the admin PIN has been changed.

The following must be fulfilled or present:

ü You are logged in as an administrator.
ü The Settings > Administration > User menu is open.

1. Press FORWARDS/BACK until a user ID (from 2 to 20) is displayed

without a four-digit PIN.

2. Press EDIT.

3. Select four digits from 0 to 9 to create a user PIN.

4. Press CONFIRM to assign the PIN to the displayed user ID.

User PIN already assigned

If you want to confirm an already existing user PIN, then the message “PIN already assigned!” appears. This PIN
is not assigned to the displayed user ID and must be changed.

1. Working in the action bar, press C until all the digits to be changed
have been deleted.

2. Working in the action bar, select digits from 0 to 9 to change the

four-digit PIN.

3. Press CONFIRM to assign the altered PIN to the displayed user ID.

Ê If the user PIN is not already assigned, the colour of the changed PIN changes from light to dark blue.

60
 8 Settings

Changing an existing admin/user PIN

When the device is delivered, the admin PIN is set to 1000 by default. MELAG recommends that you change the admin
PIN upon commissioning. The admin PIN (user ID 1) can be changed just as a user ID (user ID 2-20).

PLEASE NOTE
If the changed Admin PIN is lost, contact an authorised service or a stockist technician.

The following must be fulfilled or present:

ü You are logged in as an administrator.
ü The Settings > Administration > User menu is open.

1. Press FORWARDS/BACK until the user ID is displayed with the PIN to

be changed.

2. Press EDIT.

3. Working in the action bar, press C until all the digits to be changed
have been deleted.

4. Working in the action bar, select digits from 0 to 9 to create the

four-digit PIN.

5. Press CONFIRM to assign the altered PIN to the displayed user ID.

Deleting the user PIN

The following must be fulfilled or present:
ü You are logged in as an administrator.
ü The Settings > Administration > User menu is open.

1. Press FORWARDS/BACK until the user ID (from 2 to 20) is displayed

with the PIN to be deleted.

2. Press EDIT.

3. Working in the action bar, press C repeatedly until all four digits
have been deleted and a dash is displayed.

61
 8 Settings

4. Press CONFIRM to accept the changes.

Ê The displayed user ID is no longer assigned a user PIN.

Authentication
The administrator can activate or deactivate user authentication. When the device is delivered, authentication is deacti-
vated by default (= inactive).

Activating authentication
The following must be fulfilled or present:
ü You are logged in as an administrator.
ü The Settings > Administration > Authentication menu is open.

1. Press EDIT.

2. Press FORWARDS.

Ê The setting changes from inactive to active.

3. Press CONFIRM to accept the changes.

Ê Authentication is activated. The log shows User ID: ##.

Deactivating authentication
u Deactivating authentication is done in the same way as activating it.
Ê The setting changes from active to inactive.
Ê The log shows User ID: DEACTIVATED.

62
 8 Settings

Batch approval
The administrator can activate or deactivate batch approval. When the device is delivered, batch approval is deactivated
by default (= inactive).

Activating batch approval

The following must be fulfilled or present:
ü You are logged in as an administrator.
ü The Settings > Administration > Batch approval menu is open.

1. Press EDIT.

2. Press FORWARDS.

Ê The setting changes from inactive to active.

3. Press CONFIRM to accept the changes.

Ê Batch approval is activated. The log shows Batch approved: YES or NO.

Deactivating batch approval

u Deactivating batch approval is done in the same way as activating it.
Ê The setting changes from active to inactive.
Ê The log shows Batch approved: DEACTIVATED.

63
 9 Function checks

9 Function checks

Automatic and manual function check

Automatic
The device components are monitored and checked automatically for their functionality and interplay. Should the para-
meter thresholds be exceeded, the device will issue warning messages or malfunction messages. If necessary, it will
abort a program with the relevant notification. The device will also display messages when a program has been complet-
ed.

Manual
You can follow the program run on the display and use the log recorded to check the success of a program. Further infor-
mation is provided in chapter Logging [} page 41].

Measuring conductivity
You can access the water quality of the }DI water on the device display at any time.

1. In the main menu, press FORWARDS/BACK until Conductivity

measurement DI is displayed.

2. Press START to start the program.

64
 10 Maintenance

10 Maintenance

Video tutorial
See also “Regular Checks”.

WARNING
All maintenance work, especially that performed in the washing chamber may only be performed after
a successfully completed reprocessing program.
n Wear suitable personal protective equipment (e.g. gloves).

Maintenance intervals
Interval Measure Device component
Daily Check for soiling, deposits or damage Coarse and fine sieves, rinse arms, door seal
Monthly Check for passage/blockage Injector rail nozzles and adapters
Check for soiling, deposits or damage Accessories, plastic components
As required Cleaning Operating panel, plastic front, washing chamber,
pump sump and non-return valve
After 24 months or 1000 Maintenance Process agent hoses
cycles By the authorised customer services working in
accordance with the maintenance instructions

Regular checks and cleaning

NOTICE
Incorrect cleaning can damage the surfaces and sealing faces. Scratched or damaged surfaces and
leaking sealing faces favour soiling deposits and corrosion in the washing chamber.
n Comply with all information regarding cleaning of the parts affected.

NOTICE
When the coarse and fine sieves are missing, residue may enter the rinsing circuit and impair the
device function.
n Ensure that the coarse and fine sieves are always in place before program start.

Checking the sieves in the washing chamber

A coarse and a fine sieves are fitted in the washing chamber. The sieves are designed to hold back dirt particles or resi-
due e.g. from the instruments. They can become blocked over time.
1. Inspect the coarse and the fine sieves for small components and
soiling which have fallen from the load.

65
 10 Maintenance

2. Turn the grip of the coarse sieve anti-clockwise to its fullest extent
and remove it upwards.

3. Turn the knurled nut on the fine sieve anti-clockwise and remove the
fine sieve upwards.

4. Inspect the coarse and the fine sieves for soiling.

5. Rinse the soiled sieves under running water. Do not use any dish-
washing detergent. Remove any deposits with a soft brush.

Checking the rinse arms

Dirt particles can block the nozzles of the rinse arms. Check both rinse arms regularly and rinse the nozzles under run-
ning water if necessary.
1. Check that the coarse and the fine sieves are installed.

2. Turn the knurled nut on the rinse arm anti-clockwise and remove the
rinse arm.

3. Clean blocked nozzles with a thin pointed object.

4. Return the rinse arms and check their easy and free movement.

Checking the door seal

Check the door seal for impurities, deposits or damage on a daily basis. If necessary, clean the door seal with a moist,
non-fuzzing cloth and conventionally-available neutral liquid cleaning agent.

66
 10 Maintenance

Checking the injector rail nozzles and adapters for free passage
MELAG recommends checking the injector rail nozzles and adapters for free passage on a monthly basis.
To test whether the injector rail nozzles and adapters are blocked, hold them upright under running water. If the water
flows freely through the nozzles or adapters, they are not blocked.

Checking the accessories

Check the accessories used (especially their plastic components e.g. inserts) for damage, deposits and soiling on a
monthly basis, unless the user manual Accessories for MELAtherm indicates otherwise.

Cleaning on demand
Operating unit and plastic front
Note the following:
n Use a soft, non-fuzzing cloth.
n Use a chlorine- and vinegar-free cleaning fluid or a plastics cleaning agent.
n Check the material compatibility before application.
n Never use solvents or benzene.
n Use surface disinfectants which are suitable for plastics. Observe the manufacturer's information on the respective
surface disinfectant.

Washing chamber
Note the following:
n The washing chamber is made of high-alloy stainless steel but its surface is easily scratched.
n Clean it with a commercially-available non-abrasive stainless steel cleaning agent (no scouring scream).
n Remove any streaks remaining on the surface after cleaning with a commercially-available stainless steel polishing
spray.
n Use a soft, non-fuzzing cloth without abrasive elements (no scouring pad).

Pump sump and non-return valve

If the rinsing water has not been removed entirely after a program, the non-return valve must be cleaned.
1. Remove the coarse and fine sieves and remove the residue and
deposits from the pump sump.

2. Remove the non-return valve upwards by pulling on its grip and pull
it out of the pump sump.

3. Clean the non-return valve under running water. Do not use any
dish-washing detergent.

4. Replace the non-return valve and the fine and coarse sieves in
the pump sump.

5. Start the “Rinsing” program.

67
 10 Maintenance

Avoiding staining
Stains on the instruments or the device can develop from poor water quality. In particular, heavy metals or chloride can
result in the development of stains and/or corrosion. To avoid the development of stains and/or corrosion on the instru-
ments or the washing chamber, MELAG recommends a final rinse with demineralised water (DI water). All water-bearing
parts of the device consist of non-rusting material. This rules out the development of stains or rust caused by the device.
Often, a single instrument which drops rust can suffice to cause the development of rust on other instruments or in the
device. Further information is provided in the up-to-date Red Brochure “Instrument Reprocessing - Reprocessing of
Instruments to Retain Value” published by the AKI. See chapter “Surface Changes: Deposits, Discoloration, Corrosion,
Aging, Swelling and Stress Cracks”.

Replacing the filter in the drying fan

Exceeding the permissible level of blockage can result in a worsened drying outcome. For this reason, the device checks
the degree of blockage automatically. Exceeding the tolerances results in the issue of the relevant display message.

PLEASE NOTE
The pre-filter and the HEPA filter are replaced within the scope of the maintenance on hygienic
grounds.

1. Pull the process agent drawer forwards.

2. Undo the screw on the cover cap (pos. a) of the drying fan by hand
and lift up the cover cap.

3. Pull out the pre-filter (pos. c) upwards and replace it.

Pull out the HEPA filter (pos. b) upwards and replace it.

4. Close the cover cap and turn the screw hand-tight.

68
 10 Maintenance

Maintenance

NOTICE
Continuing operation beyond the maintenance interval can result in malfunctions in the device!
n Maintenance should only be performed by trained and authorised technicians.
n Maintain the specified maintenance intervals.

Regular maintenance is vital to ensure reliable operation and value retention of the device. All function and safety-rele-
vant components and electrical units are checked during maintenance and replaced where necessary. Maintenance is
carried out by an authorised technician in accordance with the maintenance instructions. A freely-accessible device has
a maintenance time of approx. 3 h plus test run and any work exceeding the specifications of the regular maintenance
plan.
Carry out maintenance with an original maintenance set prepared by MELAG. Only original MELAG spare parts may be
used.
Maintenance is to be performed after every 1000 cycles or 24 months at the latest.

(Process) Validation
A reproducible cleaning and disinfection outcome can only be ensured via correct operation (incl. use of suitable acces-
sories). The practice operator is responsible for ensuring reproducibility through the use of batch checks, routine checks
and/or periodic inspections (e.g. validation).
This requirement is made (in Germany) by e.g. the Medical Devices Operating Directive (§ 8 Sec. 2 MPBetreibV);
}DGKH, }DGSV and }AKI directives and the recommendations from the }Robert Koch Institute. This
requirement is also made in international regulations. This is based on }EN ISO 15883, which is also valid in Germany.
Please observe all valid national regulations and specifications. In case of doubt, consult the relevant professional asso-
ciation.
▪ Only use the loading pattern specified and approved within the scope of the validation. Changing the loading pattern
and/or accessories requires revalidation.
▪ The use of }process agents that are not recommended by MELAG (see Process agents [} page 10]) may cause an
increased effort for validation / performance requalification.
▪ MELAG cannot provide a guarantee for non-MELAG accessories, even if they are in possession of validation.
▪ The document “Recommendations for the validation of MELAtherm 10 Evolution” (doc. ME_007-22) is available for
download in the MELAG service portal for the person performing the validation and the technical service.

69
 11 Pause times

11 Pause times

Video tutorial
See also “Pause Times”.

Run the “Rinsing” program twice before reprocessing following pause times longer than two days (e.g. after a weekend).
Given an ophthalmic application, run the Ophthalmo-Program without load following pause times of more than two days
in order to obtain the requisite water quality.

Long operating pauses (longer than two weeks)

▪ Decommission the device if you plan to have an immobilisation time of over two weeks.

Decommissioning
Preparation for transport
Decommissioning in preparation for transport outside the practice should only be undertaken by MELAG-authorised per-
sons.

Following longer operating pauses

When decommissioning the device for a long pause (e.g. due to holiday), proceed as described in the following.
The following must be fulfilled or present:
ü The washing chamber is dry.
1. Switch off the device at the power switch.
2. Disconnect the power plug from the socket.
3. Turn off the water inflow.

Recommissioning

NOTICE
Air must be removed from the metering system during commissioning or after removal of the suction
lances. Air removal completely removes air bubbles from the hoses and ensures proper metering.
n Before the first reprocessing program, run the “Air removal” program.
n Then start your usual reprocessing program without a load.

u Comply with the specifications in chapter First steps [} page 20] when performing the recommissioning.

70
 11 Pause times

Transport within the practice

CAUTION
Danger of injury from incorrect carrying.
Lifting and carrying too heavy a load can result in spinal injury. Failure to comply with these provisions can
result in crushing.
n Comply with the safety regulations issued by your professional association.

Note the following:

n Empty the device entirely.
n Remove the inserts and the basis basket.
n Seal the water inlet hoses.
n Close the door before moving the device.
n Avoid strong shocks/vibrations.

Frost protection
Operate the device in a generally frost-free environment. Should any residual fluids freeze in the device, the device
should be held at room temperature for a minimum of two hours so that they can thaw.

Recommissioning after relocation

When recommissioning after a move, proceed as with the first commissioning, see First steps [} page 20].

71
 12 Malfunctions

12 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).

Not all notifications on the display are malfunction messages. Messages are issued on the display with an event number.
This number is used for identification for assistance on the MELAG website, the MELAconnect app and with the author-
ised technician.

Notification
A notification is provided for your information and to assist you in operating the device. Malfunction-free operation of the
device is still possible.

u Example:

Warning message
A warning message helps to ensure malfunction-free operation and recognition of undesirable situations. React to a
warning message quickly to prevent the resulting malfunction.

u Example:

Malfunction message
Malfunction messages are issued when it is not possible to ensure safe operation or cleaning and disinfection. These
can appear on the display shortly after switching on the device or during a program run. If a malfunction occurs during a
program run, the program will be aborted and considered unsuccessful.

u Example:

WARNING
Danger of contamination through program abort!
Aborting a program before the drying phase begins means that the load is classed as not having been
disinfected. This endangers the health of the patient and the practice team.

72
 12 Malfunctions

Displaying events in MELAconnect

You can use the MELAconnect app to access the information you need to remedy a malfunction. A QR code is displayed
in the context menu following warning and malfunction messages.

Transmitting event data

The following must be fulfilled or present:
ü The MELAG device is connected to the MELAconnect app, see Connectivity [} page 57].

1. In the context menu, press QR-CODE.

2. Open the MELAconnect app on your mobile end device and

select the Troubleshooting menu.

3. Scan the QR code on the display of the MELAtherm (to the left of
the event text).

Ê The serial number of the device and the event number are transmitted to the MELAconnect app and context-related
information on the cause and remedy is displayed.
Alternatively, you can enter the displayed event number directly in the MELAconnect app and search for it.
For devices that are already monitored, the MELAconnect app provides a link for further information directly in the dis-
played warning or malfunction message.

Notifications, warning and malfunction messages

The following tables indicate possible causes for certain events and the corresponding operating information for their
remedy. Should you be unable to find the relevant event, or your efforts do not redress the problem, you can contact your
nearest stockist or authorised MELAG customer service provider. Please have the serial number of your device, the
event number and a detailed description of the message ready.

73
 12 Malfunctions

Notifications
Event Possible cause Remedy
Banging or rattling The rinse arm bangs against instruments or 1. Interrupt the program and re-arrange the
noise in the washing containers. The load moves in the washing load.
chamber during a chamber. 2. Start the program again.
program run
White layer on the The internal water softening unit has not been Check the water hardness of the tap water
instruments adjusted correctly. and re-adjust the internal water softening unit
if necessary, see Description of the device
[} page 11].
Water-insoluble, hardened treatment residue Remove the residue manually immediately
(e.g. dental cement or root canal disinfectants) after instrument application.
remain on the instruments.
Residues or precipitates of ultrasound gel may Avoid cleaning agents and disinfectants
have remained on the instruments. based on quaternary ammonium compounds
in the manual pre-cleaning of lubricant gel
residues. Gels containing thickening agents,
especially polyacrylic acid, will precipitate
after contact with quaternary ammonium
compounds. If a change of gel is preferred,
then devices with a cation-compatible
thickening system are suitable. Contact the
manufacturer of the gel or process agents for
more information.
Poor cleaning outcome The basis basket, insert baskets / insert racks Ensure correct arrangement and avoid
are incorrectly loaded or are too full. overloading.
Load results in unwashed areas. Ensure the correct arrangement of the
instruments.
The cleaning agent is unsuitable for this type Use a suitable cleaning agent for automatic
of soiling. cleaning.
Encrusted soiling on the instruments. Do not allow soiling to dry on. Rinse off
soiling immediately.
Rinse arm nozzles or injector rail nozzles Remove blockages, see Maintenance
blocked. [} page 65].
Sieves in the pump sump are soiled. Clean the coarse and the fine sieve, see
Maintenance [} page 65].
Empty display The device is not switched on. Check that the device is connected to the
power supply and is switched on.
The fuse in domestic installation has tripped. Check the fuse in the domestic installation
This can be caused by operating a number of (for the minimum fuse protection, see the
electrical devices at the same time. type plate).
Residual moisture on The basis basket, insert baskets / insert racks Ensure correct arrangement and avoid
and/or in the are incorrectly loaded or are too full. overloading.
instruments The interior structure of the instruments is too Dry the instruments with clean (medical)
complex or the interior volume is insufficient. compressed air.
Display message: The regenerating salt is exhausted. Fill the salt container with regenerating salt.
The regenerating The signal (a tone) informs the operator that
salt is the salt in the salt container has been
exhausted. Re- recognised and that operation can be
fill the continued.
regenerating
salt.

74
 12 Malfunctions

Warning messages
Event Possible cause Remedy
214 The CF card was removed from the slot during a Once the program has been completed, working in
running program and re-inserted. the display, select the Log output and output the
current log. Do not remove the CF card during active
logging. Logging is active when the red LED
illuminates.
215 The CF card is not functioning correctly. 1. Save the logs on an external data carrier.
216 The system does not recognise a CF card or cannot 2. Select the Log output menu on the display
217 read it. and navigate to CF card formatting. For-
mat the CF card in the device, see the technical
manual.
The memory of the CF card is too large (max. 4 GB). Insert a CF card with a memory of up to 4 GB.
During insertion, the MELAG lettering must point to
the right.
MELAG recommends the use of original accessories
only.
218 While reading out the logs via the Log output Press CONFIRM to acknowledge the message. The
menu, an existing log was detected on the CF card. existing log is not overwritten.
219 The CF card is not functioning correctly. 1. Save the logs on an external data carrier.
220 The system does not recognise a CF card or cannot 2. Select the Log output menu on the display
read it. and navigate to CF card formatting. For-
mat the CF card in the device, see the technical
manual.
The memory of the CF card is too large (max. 4 GB). Insert a CF card with a memory of up to 4 GB.
During insertion, the MELAG lettering must point to
the right.
MELAG recommends the use of original accessories
only.
221 The memory space of the CF card is full. No further 1. Save the logs on an external data carrier.
logs can be saved. 2. Select the Log output menu on the display
and navigate to CF card formatting. For-
mat the CF card in the device, see the technical
manual.
222 The CF card is not functioning correctly. 1. Save the logs on an external data carrier.
223 The system does not recognise a CF card or cannot 2. Select the Log output menu on the display
224 read it. and navigate to CF card formatting. For-
mat the CF card in the device, see the technical
225 manual.
226 The memory of the CF card is too large (max. 4 GB). Insert a CF card with a memory of up to 4 GB.
227 During insertion, the MELAG lettering must point to
the right.
MELAG recommends the use of original accessories
only.
228 The CF card is too slow. Either the CF card is no 1. Save the logs on an external data carrier.
longer recognised following a reset or it was inserted 2. Insert a new CF card (max. 4 GB) in the card
in the slot under voltage. slot. During insertion, the MELAG lettering must
point to the right. MELAG recommends using
original accessories only.
229 The CF card was removed from the slot during a If the program has been concluded, working in the
writing action. display, select the Log output menu and output
the current log. Do not remove the CF card during
active logging. Logging is active when the red LED
illuminates.

75
 12 Malfunctions

Event Possible cause Remedy

230 The CF card is not functioning correctly. 1. Save the logs on an external data carrier.
The system does not recognise a CF card or cannot 2. Select the Log output menu on the display
read it. and navigate to CF card formatting. For-
mat the CF card in the device, see the technical
manual.
The memory of the CF card is too large (max. 4 GB). Insert a CF card with a memory of up to 4 GB.
During insertion, the MELAG lettering must point to
the right.
MELAG recommends the use of original accessories
only.
231 The CF card is not functioning correctly. Insert a CF card with a memory of up to 4 GB.
There is no CF card in the slot. During insertion, the MELAG lettering must point to
the right.
MELAG recommends using original accessories
only.
The system does not recognise a CF card or cannot Push the CF card in the card slot until the ejector key
read it. triggers.
232 The CF card is not functioning correctly. Press CONFIRM to acknowledge the message.
233 The CF card is currently being initialised or written.
234 The CF card is not functioning correctly. 1. Save the logs on an external data carrier.
235 The system does not recognise a CF card or cannot 2. Select the Log output menu on the display
236 read it. and navigate to CF card formatting. For-
mat the CF card in the device, see the technical
237 manual.
The memory of the CF card is too large (max. 4 GB). Insert a CF card with a memory of up to 4 GB.
During insertion, the MELAG lettering must point to
the right.
MELAG recommends the use of original accessories
only.
238 The CF card is not functioning correctly and cannot Insert a new CF card (max. 4 GB) in the card slot.
be formatted. During insertion, the MELAG lettering must point to
the right.
MELAG recommends using original accessories
only.
239 The CF card is not functioning correctly. 1. Save the logs on an external data carrier.
240 The system does not recognise a CF card or cannot 2. Select the Log output menu on the display
read it. and navigate to CF card formatting. For-
mat the CF card in the device, see the technical
manual.
The memory of the CF card is too large (max. 4 GB). Insert a CF card with a memory of up to 4 GB.
During insertion, the MELAG lettering must point to
the right.
MELAG recommends the use of original accessories
only.
372 The internal log memory of the device is full. Not all 1. Working in the display, select the Log output
logs have been outputted. menu and output the logs of the internal memo-
ry.
2. Start the program again.
3. If this message is displayed repeatedly, delete
the internal memory.

76
 12 Malfunctions

Event Possible cause Remedy

377 The system does not recognise an output medium. Check the settings in the Settings > Log
The system does not recognise a log printer, even settings menu.
though it is connected.
Working in the Settings > Log settings menu, 1. Working in the display, select the Log output
at least one output is active and Immediate menu and save the log on the CF card or the
output has been set to yes. However, a log printer computer.
is not connected. 2. Open the Settings > Log settings menu
and deactivate Immediate output. The dis-
play changes from yes to no.
386 There are logs in the internal log memory of the 1. Press CONFIRM to acknowledge the message.
device that have not yet been output. The memory is The program starts.
almost full.
2. As soon as the program is finished, select the
Log output menu on the display and output all
logs of the internal memory (CF card or external
data carrier).
394 Not all logs from the internal device memory are Press CONFIRM to acknowledge the message. The
stored on the CF card yet. logs are written to the CF card and saved.
395 Not all logs from the internal log memory of the Press CONFIRM to acknowledge the message. The
device have been output via the EDM printer. logs are output and printed.
396 Not all logs have been loaded from the internal log Press CONFIRM to acknowledge the message. The
memory of the device to the FTP server. logs are output and saved.
397 The system is unable to locate a computer for log 1. Check the network connection to the computer/
output. server.
Even though the device is connected to a computer, 2. Switch on the computer/server.
it is unable to establish a connection for log output. 3. Restart the documentation software.
The device is not connected to a computer, but in the Select the Settings > Log settings menu on
Settings > Log settings menu, the the display and deactivate the Computer
Computer parameter is set to yes (active). parameter. The display changes from yes to no.
414 The rinse aid has been exhausted. 1. Replace the rinse aid container, working in
accordance with the working safety regulations.
Alternatively, refill.
2. Start the “Air removal” program.
NOTICE! Use only process agents which you have
used before.
424 The neutraliser has been exhausted. 1. Replace the neutraliser container, working in
accordance with the working safety regulations.
Alternatively, refill.
2. Start the “Air removal” program.
NOTICE! Use only process agents which you have
used before.
425 The cleaning agent has been exhausted. 1. Replace the cleaning agent container, working in
accordance with the working safety regulations.
Alternatively, refill.
2. Start the “Air removal” program.
NOTICE! Use only process agents which you have
used before.
428 There is almost no regenerating salt left. Fill regenerating salt, see Filling the regenerating salt
[} page 23].
447 The rinse pressure in the washing chamber is too Sort the containers in the device with their openings
low. Large containers with the opening pointing facing downwards.
upwards may have been sorted into the device. This
diverts water from the rinsing process.

77
 12 Malfunctions

Event Possible cause Remedy

450 The water inflow is insufficient. Check the water supply of the device.
Open the water inflow tap completely.
500 The display of the date and time of the system clock Working in the display, select the Settings menu
are incorrect. and set the date and time correctly, see Setting the
date and time [} page 54].
501 The CF card is not functioning correctly. Insert a CF card with a memory of up to 4 GB.
There is no CF card in the slot. During insertion, the MELAG lettering must point to
the right.
MELAG recommends using original accessories
only.
The system does not recognise a CF card or cannot Push the CF card in the card slot until the ejector
read it. button triggers.
502 The system is unable to locate a computer for log Check the network connection to the computer /
output. server.
The network connection has been interrupted.
The computer / server is not switched on. Switch on the computer / server.
The documentation software has not been started. Restart the documentation software.
A computer has not been connected, but in the Working in the display, select the Settings > Log
Settings > Log settings menu, the settings menu and deactivate the Computer
Computer parameter is set to yes (active). parameter. The display changes from yes to no.
533 The temperature in the washing chamber is very CAUTION! The instruments are hot!
high. The door is blocked and cannot be unlocked
PLEASE NOTE: Take appropriate safety measures,
immediately.
e.g. keep a safe distance and wear heat-resistant
gloves, before opening the device.
Press YES to acknowledge the message. The door
can be opened.
534 The temperature in the washing chamber is very CAUTION! Danger of scalding! The instruments
high. The door is blocked and cannot be unlocked are hot.
immediately.
1. Wait until the temperature in the washing cham-
ber falls below the hazardous temperature.
2. Press CONFIRM in the action bar on the display.
549 The conductivity of the DI water is insufficient Replace the MELAdem 53/53 C cartridge.
(greater than 15 µS/cm).
The MELAdem 53/53 C cartridge is exhausted.
The DI water supply is of insufficient quality. Check the DI water supply.
560 The maximum permissible mains voltage (270 V) has Have the connection conditions checked by a
been exceeded. qualified electrician.
561 The minimum permissible mains voltage (190 V) was Have the connection conditions checked by a
undercut. qualified electrician.
562 The maximum permissible mains frequency (63 Hz) Have the connection conditions checked by a
was exceeded. qualified electrician.
563 The minimum permissible mains frequency (45 Hz) Have the connection conditions checked by a
was undercut. qualified electrician.
575 The date and time are invalid. Check the settings in the Settings menu.
622 The maximum permissible maintenance period Arrange for maintenance with an authorised
(24 months) or the maximum permissible number of customer services or a stockist technician. You can
cycles (1000 cycles) has been reached since continue to start the device.
commissioning or the last maintenance.
625 The temperature during pre-cleaning is too high. The Check the water supply to the device.
temperature during the water inflow is higher than
45 °C.

78
 12 Malfunctions

Event Possible cause Remedy

671 Insufficient conductivity (> 15 µS/cm and 1. Close the screw cap of the salt container correct-
< 25 µS/cm) was measured in the washing chamber ly.
during disinfection in the Ophthalmo-Program. 2. Setup the containers in the device with their
This could be caused by carry-over of process openings facing downwards.
agents, regenerating salt or deposits. The program 3. Check the hollow bodies before reprocessing for
successfully completed despite the warning. their free passage and correct position.
4. Clean the filter screen in the instrument connec-
tion equipment.
5. Remove and clean the coarse and fine sieves,
see Regular checks and cleaning [} page 65].
6. Insert the non-return valve in the pump sump
correctly, see Cleaning on demand [} page 67].
7. Check for foreign bodies in the non-return valve.

Malfunction messages
Event Possible cause Remedy
137 The cleaning agent metering pump is not functioning 1. Switch the device off and then on again.
correctly. The metering system may be blocked. 2. Start the program again.
139 The fan of the display is not functioning correctly. 1. Switch the device off and then on again.
2. Start the program again.
140 The fan of the diffuser is not functioning correctly. 1. Switch the device off and then on again.
2. Start the program again.
141 The neutraliser metering pump is not functioning 1. Switch the device off and then on again.
correctly. The metering system may be blocked. 2. Start the program again.
142 The rinse aid metering pump is not functioning 1. Switch the device off and then on again.
correctly. The metering system may be blocked. 2. Start the program again.
143 The solenoid valve for the cold water does not 1. Switch the device off and then on again.
switch. 2. Start the program again.
144 The solenoid valve for the regeneration does not 1. Switch the device off and then on again.
switch. 2. Start the program again.
145 The solenoid valve for the steam condenser does not 1. Switch the device off and then on again.
switch. 2. Start the program again.
146 The solenoid valve of the DI inlet hose does not 1. Switch the device off and then on again.
switch. 2. Start the program again.
147 The solenoid valve of the cold water inlet hose does 1. Switch the device off and then on again.
not switch. 2. Start the program again.
154 The temperature difference between the two 1. Switch off the device and wait approx. 30 min
155 temperature sensors (temperature control and with the door open.
temperature log) in the washing chamber is too high. 2. Switch on the device and restart the program.
156 The temperature sensor for monitoring the drying is 1. Switch off the device and wait approx. 30 min
not functioning correctly. with the door open.
2. Switch on the device and restart the program.
159 The collection tank has not been emptied correctly. 1. Switch the device off and then on again.
2. Start the program again.
160 The coarse or fine sieves are soiled. 1. Switch off the device.
2. Clean the coarse and fine sieves, see Regular
checks and cleaning [} page 65].
3. Switch on the device and restart the program.

79
 12 Malfunctions

Event Possible cause Remedy

161 The washing chamber pressure required for drying 1. Switch the device off and then on again.
has not been reached. 2. Start the program again.
162 The requisite rinse pressure has not been reached. 1. Switch the device off and then on again.
2. Start the program again.
163 The cleaning agent metering pump is not functioning 1. Switch the device off and then on again.
correctly. The metering system may be blocked. 2. Start the program again.
165 The fan of the display is not functioning correctly. 1. Switch the device off and then on again.
2. Start the program again.
166 The fan of the diffuser is not functioning correctly. 1. Switch the device off and then on again.
2. Start the program again.
167 The neutraliser metering pump is not functioning 1. Switch the device off and then on again.
correctly. The metering system may be blocked. 2. Start the program again.
168 The rinse aid metering pump is not functioning 1. Switch the device off and then on again.
correctly. The metering system may be blocked. 2. Start the program again.
169 The solenoid valve for the cold water does not 1. Switch the device off and then on again.
switch. 2. Start the program again.
170 The solenoid valve for the regeneration does not 1. Switch the device off and then on again.
switch. 2. Start the program again.
171 The solenoid valve for the steam condenser does not 1. Switch the device off and then on again.
switch. 2. Start the program again.
172 The solenoid valve of the DI inlet hose does not 1. Switch the device off and then on again.
switch. 2. Start the program again.
173 The solenoid valve of the cold water inlet hose does 1. Switch the device off and then on again.
not switch. 2. Start the program again.
257 The connection to the conductivity sensor has been 1. Switch the device off and then on again.
interrupted. No or an incorrect conductivity 2. Start the program again.
measurement is stated.
410 The rinse aid has been exhausted. 1. Replace the rinse aid container, working in
accordance with the working safety regulations.
Alternatively, refill.
NOTICE! Use only process agents which you
have used before.
2. Start the “Air removal” program.
411 The neutraliser has been exhausted. 1. Replace the neutraliser container, working in
accordance with the working safety regulations.
Alternatively, refill.
NOTICE! Use only process agents which you
have used before.
2. Start the “Air removal” program.
412 The cleaning agent has been exhausted. 1. Replace the cleaning agent container, working in
accordance with the working safety regulations.
Alternatively, refill.
NOTICE! Use only process agents which you
have used before.
2. Start the “Air removal” program.

80
 12 Malfunctions

Event Possible cause Remedy

426 No cleaning agent is being pumped. 1. Replace the cleaning agent container, working in
The cleaning agent container has been exhausted, accordance with the working safety regulations.
air may have been transported. Alternatively, refill.
NOTICE! Use only previously used process
agents!
2. Start the “Air removal” program.
The hose to the suction lance is kinked. 1. Eliminate any kinks or pinch points on the pro-
cess agent hoses.
2. Start the “Air removal” program.
Air bubbles have developed in the metering system Start the “Air removal” program.
after long standstill times.
427 No neutraliser is being pumped. 1. Replace the neutraliser container, working in
The neutraliser container has been exhausted, air accordance with the working safety regulations.
may have been transported. Alternatively, refill.
NOTICE! Use only previously used process
agents!
2. Start the “Air removal” program.
The hose to the suction lance is kinked. 1. Eliminate any kinks or pinch points on the pro-
cess agent hoses.
2. Start the “Air removal” program.
Air bubbles have developed in the metering system Start the “Air removal” program.
after long standstill times.
431 No cleaning agent is being pumped. 1. Replace the cleaning agent container, working in
The cleaning agent container is empty or almost accordance with the working safety regulations.
empty. Alternatively, refill.
NOTICE! Use only previously used process
agents!
2. Start the “Air removal” program.
The hose to the suction lance is kinked. 1. Eliminate any kinks or pinch points on the pro-
cess agent hoses.
2. Start the “Air removal” program.
Air bubbles have developed in the metering system Start the “Air removal” program.
after long standstill times.
432 No neutraliser is being pumped. 1. Replace the neutraliser container, working in
The neutraliser container is empty or almost empty. accordance with the working safety regulations.
Alternatively, refill.
NOTICE! Use only process agents which you
have used before.
2. Start the “Air removal” program.
The hose to the suction lance is kinked. 1. Eliminate any kinks or pinch points on the pro-
cess agent hoses.
2. Start the “Air removal” program.
Air bubbles have developed in the metering system Start the “Air removal” program.
after long immobilization times.
433 Water is in the pump sump after pumping out. Clean the coarse and fine sieves, see Regular
The coarse or fine sieve is soiled. checks and cleaning [} page 65].

The non-return valve in the pump sump is missing or Insert the non-return valve in the pump sump
fitted incorrectly. correctly, see Regular checks and cleaning
[} page 65].
The non-return valve is blocked by a foreign body. Check the non-return valve for foreign bodies and
remove them if you find any.

81
 12 Malfunctions

Event Possible cause Remedy

434 Water is in the pump sump after pumping out. Clean the coarse and fine sieves, see Regular
The coarse or fine sieve is soiled. checks and cleaning [} page 65].

The non-return valve in the pump sump is missing or Insert the non-return valve in the pump sump
fitted incorrectly. correctly, see Regular checks and cleaning
[} page 65].
The non-return valve is blocked by a foreign body. Check the non-return valve for foreign bodies and
remove them if you find any.
The outlet hose is kinked. Check the installation of the outlet hose.
The siphon or outlet hose is blocked. Check the siphon and the outlet hose for blockage.
440 The current program has been terminated Press CONFIRM to acknowledge the message.
prematurely. The load is classed as not cleaned and
disinfected.
449 The rinse pressure in the washing chamber is too Check the water inflow of the device. Open the water
low. inflow tap completely.
Insufficient water inflow.
The basis basket has been inserted incorrectly or not Insert the basis basket in the washing chamber
at all. correctly, see Inserting the basis basket [} page 23].
Too many non-filled apertures on the injector rail. Seal non-filled apertures on the injector rail with a
screw plug.
The coarse or fine sieves are soiled. Remove and clean the coarse and fine sieves, see
Regular checks and cleaning [} page 65].
Large containers with the opening pointing upwards Sort the containers in the device with their openings
may have been sorted into the device. This diverts facing downwards.
water from the rinsing process.
Strong foam generation: The instruments have been Rinse the instruments thoroughly before
pre-cleaned in or placed in a foam-generating reprocessing.
solution and have then been subject to insufficient
rinsing.
Strong foam generation: Strong soiling of the filter Remove and replace the soiled filter disc. Clean the
disc in the universal adapter for transmission reusable filter screen.
instruments.
Strong foam generation: Unsuitable process agents Use only those process agents suitable for the
(rinse aid or cleaning agent) have been used. device.
451 The temperature difference between the two Clean the upper rinse arm and check its ease of
temperature sensors in the washing chamber is too movement.
great. The temperature sensors were not covered
with water sufficiently. The upper rinse arm revolves
too slowly.
462 The water inflow is insufficient. Check the water inflow of the device.
464 The water inflow tap has not been opened Open the water inflow tap completely.
completely.
The sieve in the cold water connection is blocked. Remove and clean the sieve in the cold water
connection.
The cold water inlet hose is kinked. Check the installation of the cold water inlet hose.
466 Insufficient DI water inflow. Check the DI water supply.
The DI water supply has been interrupted. Check the DI water system for its correct function.
The sieve in the DI water connection is blocked. Remove and clean the sieve in the DI water
connection.
The DI water inlet hose is kinked. Check the installation of the DI water inlet hose.

82
 12 Malfunctions

Event Possible cause Remedy

467 The water inflow is insufficient. Check the water inflow of the device.
The water inflow tap has not been opened Open the water inflow tap completely.
completely.
The sieve in the cold water connection is blocked. Remove and clean the sieve in the cold water
connection.
The cold water inlet hose is kinked. Check the installation of the cold water inlet hose.
468 Insufficient DI water inflow. Check the DI water supply.
The DI water supply has been interrupted. Check the DI water system for its correct function.
The sieve in the DI water connection is blocked. Remove and clean the sieve in the DI water
connection.
The DI water inlet hose is kinked. Check the installation of the DI water inlet hose.
471 The door of the device was not locked correctly Switch the device off and then on again.
during the program start.
474 The HEPA filter is not recognised. Insert the HEPA filter.
A HEPA filter has not been inserted.
The HEPA filter for the drying fan has not been Check whether the HEPA filter for the drying fan has
inserted correctly. been inserted correctly.
The cover cap of the drying fan has not been locked Close the cover cap of the drying fan correctly.
correctly.
476 The requisite pressure for the drying has not been Check whether the HEPA filter has been inserted
reached. correctly in the drying fan.
The HEPA filter for the drying fan has not been
inserted correctly.
The cover cap on the drying fan has not been locked Close the cover cap of the drying fan correctly.
correctly.
484 The rinse pressure in the washing chamber is too Check the water inflow of the device. Open the water
low. inflow tap completely.
The water inflow is insufficient.
The basis basket has been inserted incorrectly or not Insert the basis basket in the washing chamber
at all. correctly. The injector rail should be located on the
right-hand side and dock with the blind cap on the
fitting of the rear wall, see Inserting the basis basket
[} page 23].
Too many non-filled apertures on the injector rail. Seal non-filled apertures on the injector rail with a
screw plug.
The coarse or fine sieves are soiled. Remove and clean the coarse and fine sieves, see
Regular checks and cleaning [} page 65].
Large containers with the opening pointing upwards Sort the containers in the device with their openings
may have been sorted into the device. This diverts facing downwards.
water from the rinsing process.
Strong foam generation: the instruments have been Rinse the instruments thoroughly before
pre-cleaned with a foam-generating solution and reprocessing.
have then been subject to insufficient rinsing.
Strong foam generation: strong soiling of the filter Remove and replace the soiled filter disc. Clean the
disc in the universal adapter for transmission reusable filter screen.
instruments.
Strong foam generation: unsuitable process agents NOTICE! Use only those process agents suitable
(rinse aid or cleaning agent) have been used. for this device.
505 The salt storage has been exhausted. No new Fill regenerating salt, see Filling the regenerating salt
regeneration can be performed. [} page 23]. A program can be started if the salt has
dissolved in the water. Do not start the program until
the regenerating salt has been filled and the signal
tone has sounded.

83
 12 Malfunctions

Event Possible cause Remedy

509 Liquid in the device floor trough. CAUTION! Avoid contact with liquids in the floor
trough; they can contain process agents.
1. Switch off the device.
2. Close the water inflow tap.
3. Please contact the authorised technician.
510 During a program run, the water level in the washing 1. Press CONFIRM in the action bar on the display.
chamber was measured to be too high.
2. Close the door and start the program again.
512 The running program was interrupted by a power WARNING! Danger of contamination
failure.
1. Press CONFIRM to acknowledge the message.
2. Start the program again.
524 The door of the device is blocked and cannot be Check the door area for blockages.
closed correctly.
531 The emergency-opening on the door was actuated WARNING! Danger of contamination
during a program run.
1. Press CONFIRM to acknowledge the message.
2. Close and lock the door correctly.
3. Start the program again.
535 The fine sieve has been fitted incorrectly. Insert the fine sieve correctly. The arrow on the fine
sieve must point towards the left-hand corner of the
washing chamber.
536 The upper / lower rinse arm is mechanically blocked. Check the freedom of motion of the upper / lower
537 rinse arm.
The impulse nozzle of the upper / lower rinse arm is Remove and clean the upper / lower rinse arm.
538
blocked.
539
The basis basket has been inserted in the incorrect Insert the basis basket correctly. The injector rail
position or not at all. must dock on to the connection fitting.
Fine deposits in the rinse arm bearing or on the Remove and clean the upper / lower rinse arm.
sliding disc. Clean the sliding disc with a cloth.
The water inflow is not sufficient. Check the water inflow to the device:
1. Remove and clean the sieve in the cold water
connection.
2. Check the installation of the inlet hose.
3. Open the water inflow tap completely.
546 The cartridge of the MELAdem 53/53 C was not 1. Remove the air from the cartridge of the
vented correctly. A sudden flow of water causes MELAdem 53/53 C (see “Commissioning” in the
incorrect readings for a short time. user manual of the water treatment unit).
2. Start the program again.
548 The conductivity of the DI water is insufficient Replace the MELAdem 53/53 C cartridge.
(greater than 60 µS/cm).
The MELAdem 53/53 C cartridge is exhausted.
The DI water supply is of insufficient quality. Check the DI water supply.
571 The program cannot be started as brine is still in the Start the “Regeneration” program.
water softening unit or washing chamber. Only the
“Regeneration” program may be started.
583 The water inflow was interrupted during the active 1. Open the water inflow tap completely.
program. 2. Start the program again.
The water inflow must be ensured during the entire
duration of the active program.

84
 12 Malfunctions

Event Possible cause Remedy

620 Strong foam generation in the washing chamber. Load the instruments into the MELAtherm without
The instruments are precleaned or placed in a foam- precleaning or rinse them thoroughly after placing in
generating solution. a solution.

Non-qualified process agents (rinse aid or cleaning NOTICE! Use only process agents suitable for this
agent) have been used. device.
The metering concentration has been set incorrectly. Check the settings of the metering concentration and
if necessary, arrange for correction by an authorised
technician.
Strong soiling of the filters in the transmission Clean or renew the filters at regular intervals.
instrument adapter.
624 The collection tank is not pumped out. 1. Switch the device off and then on again.
2. Start the program again.
626 The temperature during pre-cleaning is too high. Check the water supply to the device.
632 The coarse or fine sieves are soiled. 1. Remove and clean the coarse and fine sieves,
see Regular checks and cleaning [} page 65].
2. Switch the device off and then on again.
3. Start the program again.
653 The water inflow was interrupted during the active 1. Open the water inflow tap completely.
program. 2. Start the program again.
The water inflow must be secured during the entire
duration of the active program.
660 The power supply for the DTA device version is 1. Check whether the power plug has been insert-
661 insufficient. ed correctly in the socket.
2. Check the fuses in the sub-distribution.
662 The upper rinse arm is soiled. Remove the upper rinse arm and clean the nozzles,
see Regular checks and cleaning [} page 65].
669 The coarse or fine sieves are strongly soiled. 1. Remove and clean the coarse and fine sieves,
see Regular checks and cleaning [} page 65].
2. Switch the device off and then on again.
3. Start the program again.
670 The water inflow was interrupted during the active 1. Open the water inflow tap completely.
program. 2. Start the program again.
The water inflow must be ensured during the entire
duration of the active program.
672 Insufficient conductivity (≥ 25 µS/cm) was measured 1. Close the screw cap of the salt container correct-
in the washing chamber during disinfection in the ly.
Ophthalmo-Program. 2. Setup the containers in the device with their
This could be caused by carry-over of process openings facing downwards.
agents, regenerating salt or deposits. The program 3. Check the hollow bodies before reprocessing for
successfully completed despite the warning. their free passage and correct position.
4. Clean the filter screen in the instrument connec-
tion equipment.
5. Remove and clean the coarse and fine sieves,
see Regular checks and cleaning [} page 65].
6. Insert the non-return valve in the pump sump
correctly, see Cleaning on demand [} page 67].
7. Check for foreign bodies in the non-return valve.
673 The Ophthalmo-Program does not start. A DI 1. Connect the DI water.
connection has not been set in the Settings 2. Working in the display, select the Settings >
menu. DI water menu and set the parameter to yes.

85
 12 Malfunctions

Event Possible cause Remedy

675 Water is in the pump sump after pumping out. Remove and clean the coarse and fine sieves, see
The coarse or fine sieves are soiled. Regular checks and cleaning [} page 65].

The non-return valve in the pump sump is missing or Insert the non-return valve in the pump sump
has been fitted incorrectly. correctly.
The non-return valve is blocked by foreign bodies. Check whether foreign bodies are in the non-return
valve, see Cleaning on demand [} page 67].

86
 13 Technical data

13 Technical data

MELAtherm 10 Evolution DTA/DTB device dimensions

Device types Semi-integrated unit Free standing Top-frame device
Device dimensions 81.8 x 59.8 x 68.1 cm 83.6 x 59.8 x 68.1 cm 124 x 59.8 x 68.1 cm
(H x W x D)2)
Empty weight 88 kg 94 kg 115 kg
Operating weight 122 kg 128 kg 191 kg

Device types MELAtherm 10 Evolution DTA MELAtherm 10 Evolution DTB

Washing chamber (H x W x D) 29 x 45.5 x 42.3 cm
Washing chamber volume 84 l
Electrical connection
Power supply 3N AC 380-415 V, 50 Hz AC 220-240 V, 50 Hz
Max. voltage range 360-440 V 207-253 V
Electrical power 10.3 kW 3.4 kW
Building fuses 3x 16 A, separate power circuit with 1x 16 A, separate power circuit with
Type B 16 A fuse, Additional residual Type B 16 A fuse, Additional residual
current device with 30 mA current device with 30 mA
Overvoltage category Transient overvoltage up to the values of overvoltage category II
Length of the power cable 2m
Degree of air pollution (in accordance Category 2
with EN 61010-1)
Ambient conditions
Installation location Interior of a building
Max. noise emission (Drying) 73 dB(A)
Noise emission median value 66.2 dB(A)
Waste heat (with max. solid load) 0.98 kWh (3.5 MJ)
Ambient temperature 5-40 °C (recommended max. 25 °C)
Air pressure 750-1060 mbar
Relative humidity max. 80 % at temperatures up to 31 °C, max. 50 % at 40 °C (decreasing in a
linear fashion)
Degree of protection (in accordance with IP20
IEC 60529)
Max. altitude 1500 m (it may be necessary to reduce the disinfection temperature
depending on the installation height; see the technical manual)
Cold water
Connection cold water / DI water 3/4“ internal thread (for the connection to a standard 3/4“ connection with
external thread)
Cold water quality Comply with the specifications of the Drinking Water Ordinance (TrinkwV) or
the applicable local specifications
DI water quality (max. permissible from 15 µS/cm warning, from 60 µS/cm malfunction,
conductivity) Ophthalmo-Program: from 25 µS/cm malfunction
Min. flow pressure 1.5 bar at 8 l/min
Netherlands: 2 bar at 8 l/min
Recommended flow pressure 2.5 bar at 8 l/min
Netherlands: 3 bar at 8 l/min
Max. water pressure (static) 10 bar
Cold water temperature 1-26 °C

2)
Appropriate for a 60 cm deep working surface

87
 13 Technical data

Device types MELAtherm 10 Evolution DTA MELAtherm 10 Evolution DTB

Wastewater
Wastewater connection DN21
Max. wastewater temperature 93 °C (< 1 min, approx. 7 l)
Amount of wastewater per hour approx. 38 l (in short intervals)
Capacity of drain pump max. 40 l/min (volume in outlet hose)
Length of the inlet and outlet hose each 1.80 m (extension optionally available)

88
 14 Accessories and spare parts

14 Accessories and spare parts

You can obtain the specified articles together with an overview of further accessories from your stockist. Information
regarding the instrument reprocessing accessories can be found in the current MELAG price list.
Article Art. no.
Optionally available Base cabinet/floor unit (H x W x D) 40 x 59.8 x 59.8 cm ME11021
Stainless steel cover plate (H x W x D) 1.8 cm x 59.8 cm x 59.8 cm ME65310
Water treatment MELAdem 53 with 2 containers (20 l each) ME01038
MELAdem 53 C with 2 containers (15 l each) ME01036
Documentation CF card ME01043
Card reader for CF card ME01048
MELAprint 44 log printer ME01144
Network adapter for MELAprint ME40295
Process agents MEtherm 50 (mildly-alkaline enzymatic cleaning agent) ME11620
MEtherm 55 C (citric acid-based neutraliser) ME11621
MEtherm 56 P (phosphoric acid-based neutraliser) ME11622
MEtherm 61 (rinse aid) ME11627
Rinse aid storage container (1 l) ME60910
Others HEPA filter ME51240
Pre-filter drying fan ME68130
Funnel for salt container ME68200
Regenerating salt for MELAtherm ME80000

89
 15 Documentation and approval

15 Documentation and approval

Video tutorial
See also “Batch Approval”.

P*) D**) B***) Program / Process Process ap- Instrument Remarks Signature
load success- proval? approval?
ful?
yes yes yes
reprocessed on: no no no
-- -- partially
yes yes yes
reprocessed on: no no no
-- -- partially
yes yes yes
reprocessed on: no no no
-- -- partially
yes yes yes
reprocessed on: no no no
-- -- partially
yes yes yes
reprocessed on: no no no
-- -- partially
yes yes yes
reprocessed on: no no no
-- -- partially
yes yes yes
reprocessed on: no no no
-- -- partially
yes yes yes
reprocessed on: no no no
-- -- partially
yes yes yes
reprocessed on: no no no
-- -- partially
yes yes yes
reprocessed on: no no no
-- -- partially
yes yes yes
reprocessed on: no no no
-- -- partially
yes yes yes
reprocessed on: no no no
-- -- partially
) ) )
* personal number | ** device number | *** batch number

90
 Glossary

Glossary
A0-value DGSV
The A0 value represents a standard for the elimination of Abb.: “Deutsche Gesellschaft für Sterilgutverordnung”
microorganisms and the deactivation of viruses in the dis- (German Association for the Sterilized Equipment Ordi-
infection procedure with damp heat. The A0 value depends nance). The DSGV training centres are specified in
on temperature and time. DIN 58946, part 6 as “Requirements of personnel”.

AKI DI water
AKI is the abbreviation for “Arbeitskreis Instrumentenauf- Demineralised water (DI water) is water (H2O) without the
bereitung” (Instrument Reprocessing Working Group) salts found in normal spring and tap water, which are dis-
solved as anions and cations.
Authorised technician
An authorised technician is a person intensively trained Effectiveness range
and authorised by MELAG who has sufficient specific The effectiveness of disinfection measures and agents
device and technical knowledge. to perform maintenance against pathogens is divided by the Robert Koch Institute
and installation work on MELAG devices. Only they may into microbiological effect ranges. The effectiveness rang-
carry out this work. es are identified by the letters A, B, C and D. [see also
RKI]
Batch
The batch is the composition of items which has been sub- EN ISO 15883
ject to the same reprocessing procedure. Standard - Washer-disinfectors

BfArM EN ISO 17664

Abbreviation for “Bundesinstitut für Arzneimittel und Mediz- Standard - Reprocessing of healthcare products - Informa-
inprodukte” (Federal Institute for Drugs and Medical Prod- tion to be provided by the medical device manufacturer for
ucts) in Germany the reprocessing of medical devices

CF card HEPA filter

The CF card is a memory medium for digital data; Com- The HEPA filter is a filter group H filter element (particulate
pact Flash is an official standard, i.e. these memory cards material filter), in accordance with EN 1822-1. This group
can be used in every device fitted with the corresponding is sub-divided into two classes, H13 and H14. Filter ele-
slot. The CF card can be read by every device that sup- ments are classified in accordance with their filter capacity.
ports the standard and where necessary, written on. The HEPA filter is used in medical environments to purify
the air microbiologically from suspended particles.
Cleaning agent
A cleaning agent (e.g. MEtherm 50) is a substance or mix- KRINKO
ture of chemical substances that assist in the cleaning of Abbreviation for “Kommission für Krankenhaushygiene und
medical products. Infektionsprävention” (Commission for Hospital Hygiene
and Infection Prevention) at the Robert Koch Institute in
Competent personnel Germany.
Trained personnel in accordance with national specifica-
tions for the respective area of application (dentistry, medi- Load
cine, podiatry, veterinary medicine, cosmetics, piercing, The load refers to all possible instruments such as basins,
tattoo) with the following contents: knowledge of instru- glassware and other objects which can be reprocessed in
ments, hygiene and microbiology, risk assessment and a washer-disinfector.
classification of medical devices and instrument reprocess-
ing. Neutraliser
The neutraliser is a citric acid-based (e.g. MEtherm 55) or
Conductivity phosphoric acid-based (e.g. MEtherm 56) acidic medium
is the ability of a conductive chemical substance or mixture which can be added to the subsequent rinse water in auto-
of substances to conduct or transfer energy or other sub- matic reprocessing after an alkaline cleaning in order to
stances or particles in space. neutralise the alkalinity in order to assist in the removal of
the cleaning agent.
DGKH
Abbreviation for “Deutsche Gesellschaft für Kranken- pH Value
haushygiene e.V.” (German Society of Hospital Hygiene) The pH value is a measure of the strength of the acid or
alkali effect of a watery solution.

91
 Glossary

Process agent
A process agent is a composition of chemical compounds
for designed for reprocessing purposes e.g. of medical
instruments. Process agents used in a washer-disinfector
consist of a cleaning agent, neutraliser and rinse aid.

Qualified electrician
Person with suitable technical training, knowledge and
experience so that he or she can recognise and avoid haz-
ards that can be caused by electricity [see IEC 60050 or
for Germany VDE 0105-100].

Reprocessing
Reprocessing is a measure to prepare a new or used
healthcare device for its intended purpose. Reprocessing
includes cleaning, disinfection, sterilization and similar pro-
cedures.

Rinse aid
The rinse aid (e.g. MEtherm 61) is a mixture of chemical
substances which can be added to the last subsequent
rinse water used in an automatic reprocessing process to
achieve better and quicker drying. The active agents con-
tained in the subsequent rinse agent reduce the surface
tension of the subsequent rinse water, thereby minimising
the adherent residual moisture.

RKI
Abbreviation for “Robert Koch Institute”. It is one of the
most important bodies for the safeguarding of public health
in Germany.

92
 BA_Evo_10DT_EN.pdf | Rev. 10 - 22/4047 | Modification date: 2022-11-23
MELAG Medizintechnik GmbH & Co. KG
Geneststraße 6-10
10829 Berlin
Germany
Email: [email protected]
Web: www.melag.com
Original instructions

Responsible for content: MELAG Medizintechnik GmbH & Co. KG

We reserve the right to technical alterations

Your stockist