MELAG MELAtherm 10 Evolution User manual

User Manual
MELAtherm® 10 Evolution
Washer-Disinfector
from software version 3.0.20
EN
Dear customer,
We thank you for your confidence demonstrated by the purchase of this MELAG product. As an owner-run and operated
family concern founded in 1951, we have a long history of successful specialization in hygiene products for practice-
based use. Our focus on innovation, quality and the highest standards of operational reliability has established MELAG
as the world’s leading manufacturer in the instrument reprocessing and hygiene field.
You, our customer are justified in your demand for the best products, quality and reliability. Providing “competence in
hygiene” and “Quality – made in Germany”, we guarantee that these demands will be met. Our certified quality 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 .......................................................................................................................................................13
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 tests.....................................................................................................................................................................64
Automatic and manual functional 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
5
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
see Chapter 2 Reference to another text section within this document.
Universal-
Program
Words or phrases appearing on the display of the device are marked as display text.
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.
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 from the manufacturer of the process
agents. Information regarding this topic is provided in the safety data sheets or can be obtained directly from the manu-
facturer 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.

2 Safety
6
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
nThe instrument reprocessing using this washer-disinfector may only be carried out by }competent personnel.
nThe operator must ensure that the users have been trained in the operation and safe handling of the device.
nThe operator must ensure that the users are regularly trained in the operation and safe handling of the device.
Setup, installation and commissioning
nCheck the device after unpacking for any damage suffered during transport.
nThe device should only be setup, installed and commissioned by MELAG authorised persons.
nThe connections for electrical provision and water supply and discharge must be setup by trained personnel.
nThe disconnection device must be freely accessible after installation so that the device can be taken from the elec-
tricity supply at any time.
nDTA 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.
nUsing the optional electronic leak detector (water stop) minimises the risk of water damage.
nThe device is not suitable for operation in explosive atmospheres.
nInstall and operate the device in a frost-free environment.
nThe 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.
nThe documentation media (computer, CF card reader etc.) must be placed in such a way that they cannot come into
contact with liquids.
nObserve all the information contained in the technical manual during commissioning.
Power cable and power plug
nComply with all legal requirements and locally-specified connection conditions.
nNever operate the device if the plug or power cable are damaged.
nThe power cable or plug should only be replaced by }authorised technicians.
nNever damage or alter the power plug or cable.
nNever unplug by pulling on the power cable. Always take a grip on the plug.
nEnsure that the power cable does not become jammed in.
nNever lead the cable along a source of heat.
nNever fix the power cable with sharp objects.
Daily operation
nOnly 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.
nUse only original MELAG accessories or those from other suppliers authorised for use by MELAG.
nWhen using non-MELAG accessories for the mounting of instruments (especially hollow-body instruments) comply
with the information from the manufacturer of the accessories.
nComply 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.

2 Safety
7
nThe fore ventilation slots may not be covered.
nNever 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
nHandle all }process agents with care. The cleaning agents, neutralisers and rinse aids contain irritants and even
caustic substances.
nComply with the safety instructions in the documentation of the process agents and wear the prescribed protective
equipment.
nIn 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
nAvoid 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.
nAvoid strong shocks/vibrations.
Maintenance
nMaintenance should only be performed by }authorised technicians.
nMaintain the specified servicing intervals.
Repair
nNever 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
nShould the device issue the same malfunction message repeatedly, turn off the device and if necessary, inform your
stockist.
nThe device may only be serviced by }authorised technicians.
Notification requirement in the event of serious accidents in the European Economic Area
nPlease 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.

3 Performance specifications
8
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 clin-
ic or medical and dental practices. }ENISO15883-1 and -2 defines it as a washer-disinfector intended for }reprocessing
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 inva-
sive 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 (e.g. MEtherm). 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:
nThermo-unstable instruments e.g. flexible endoscopes
nLaboratory waste requiring disposal
nCrockery
nBedpans
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.

3 Performance specifications
9
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.

3 Performance specifications
10
Process agents
Note the following:
nUse only suitable }process agents. The use of unsuitable process agents can impair the reprocessing result and
material compatibility.
nMELAG recommends using MEtherm process agents. The suitability of the MEtherm process agents for use in
MELAtherm has been proven in comprehensive cleaning effectiveness and material-compatibility tests.
nOther process agents must not be used if their performance and safety for use with the MELAtherm have not been
conformed by the manufacturer of the process agents.
nPlease address all queries relating to the compatibility of process agents with the instruments to the instrument
manufacturer.
nEvery change of a process agent in a validated device necessitates revalidation. Comply with all national
regulations.
Pre-set metering concentration
The pre-set metering concentrations have been harmonised to MEtherm.
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
When using process agents from other manufacturers, it may be necessary to adjust the metering
concentration. Only trained and authorised service technicians are permitted to change the metering
concentration.