MELAG MELAtherm 10 Evolution DTA 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 treatment and hygiene field.
You, our customer are justified in your demand for the best products, quality and reliability. Providing “competence in
hygiene” and “Quality – made in Germany”, we guarantee that these demands will be met. Our certified quality 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 ...............................................................................................................................................................6
Symbols used.......................................................................................................................................................................6
Formatting rules ...................................................................................................................................................................6
Disposal ...............................................................................................................................................................................6
2 Safety.....................................................................................................................................................................................7
3 Performance specifications ................................................................................................................................................9
Intended use ........................................................................................................................................................................9
User benefits ........................................................................................................................................................................9
Program sequence.............................................................................................................................................................10
Process agents ..................................................................................................................................................................11
4 Description of the device...................................................................................................................................................12
Scope of delivery................................................................................................................................................................12
Views of the device ............................................................................................................................................................12
Symbols on the device .......................................................................................................................................................14
Operating panel and acoustic signal ..................................................................................................................................16
Menu structure ...................................................................................................................................................................19
Water softening unit ...........................................................................................................................................................20
5 First steps ...........................................................................................................................................................................21
Setup and installation.........................................................................................................................................................21
Water supply ......................................................................................................................................................................21
Switching the device on and off .........................................................................................................................................22
Video tutorials ....................................................................................................................................................................22
MELAconnect App .............................................................................................................................................................23
Opening and closing the door ............................................................................................................................................23
Manual door emergency-opening ......................................................................................................................................24
Inserting the basis basket ..................................................................................................................................................24
Filling the regenerating salt ................................................................................................................................................25
Regenerating the water softening unit ...............................................................................................................................26
Metering process agents....................................................................................................................................................26
Holding process agents ready............................................................................................................................................27
Removing air from the metering system ............................................................................................................................29
6 Cleaning and disinfection..................................................................................................................................................30
Type of load .......................................................................................................................................................................30
Wet/dry storage..................................................................................................................................................................30
Preparation and pre-cleaning.............................................................................................................................................30
Arranging the load..............................................................................................................................................................31
Reprocessing hollow-body instruments .............................................................................................................................31
Reprocessing dental transmission instruments..................................................................................................................32
Reprocessing ophthalmological instruments......................................................................................................................33
Overview of programs ........................................................................................................................................................34
Selecting, starting and following the program ....................................................................................................................35
Manual program abort........................................................................................................................................................36
Authentication and batch approval.....................................................................................................................................37

Contents
Removing the load after program end................................................................................................................................41
7 Logging ...............................................................................................................................................................................42
Batch documentation .........................................................................................................................................................42
Output media......................................................................................................................................................................42
Outputting logs immediately and automatically..................................................................................................................44
Subsequent log output .......................................................................................................................................................45
Deleting the saved logs......................................................................................................................................................45
Determining the format for the program logs .....................................................................................................................46
Finding the logs..................................................................................................................................................................48
8 Settings ...............................................................................................................................................................................49
Settings menu ....................................................................................................................................................................49
Log settings........................................................................................................................................................................50
Setting the date and time ...................................................................................................................................................56
Setting the display brightness ............................................................................................................................................57
Setting the idle mode .........................................................................................................................................................58
Setting the volume of the signal tone .................................................................................................................................58
Setting the volume of the key tone.....................................................................................................................................59
Connectivity........................................................................................................................................................................59
Setting the language ..........................................................................................................................................................60
Setting the water supply.....................................................................................................................................................61
Setting the water hardness ................................................................................................................................................61
Administrative settings .......................................................................................................................................................62
9 Function tests.....................................................................................................................................................................68
Automatic and manual functional check.............................................................................................................................68
Measuring conductivity.......................................................................................................................................................68
10 Maintenance......................................................................................................................................................................69
Maintenance intervals ........................................................................................................................................................69
Regular checks and cleaning .............................................................................................................................................69
Cleaning on demand ..........................................................................................................................................................71
Avoiding staining ................................................................................................................................................................72
Changing the filter in the drying fan ...................................................................................................................................72
Maintenance.......................................................................................................................................................................73
(Process) Validation ...........................................................................................................................................................74
11 Pause times ......................................................................................................................................................................75
Decommissioning...............................................................................................................................................................75
Transport within the practice ..............................................................................................................................................76
12 Malfunctions .....................................................................................................................................................................77
Displaying events in MELAconnect....................................................................................................................................78
General events...................................................................................................................................................................78
Warnings ............................................................................................................................................................................80
Malfunction messages .......................................................................................................................................................85

Contents
13 Technical data ..................................................................................................................................................................93
14 Accessories and spare parts ..........................................................................................................................................95
15 Documentation and approval..........................................................................................................................................96
Glossary .................................................................................................................................................................................97

1 General guidelines
6
1 General guidelines
Read this user manual carefully before commissioning the device. The user manual includes important
safety information. The functionality and value-retention of this device depends on the care accorded to it.
Store this user manual carefully and in close proximity to your device. It represents a component of the
product.
Should the user manual no longer be legible, damaged or lost, obtain a new copy from MELAG. State the
device type and your address in an e-mail.
The device type is specified on the type plate on the rear of the device.
Should the user manual no longer be legible, is damaged or has been lost, please obtain a new copy from
MELAG. State the device type and your postal address in an e-mail.
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.
Disposal
MELAG devices are synonymous with high quality and a long life-span. When you eventually need to
decommission your MELAG device, we offer a special disposal service. 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 selec-
ted for their environmentally-friendly disposability and can be recycled. Returning the packaging to the
material flow reduces the amount of waste and saves raw materials. Dispose of all non-required packaging
materials at the collection points of the dual system.
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 manufacturer of the process agents.

2 Safety
7
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 per-
sonnel.
Set-up, installation and commissioning
nCheck the device after unpacking for any damage suffered during transport.
nThe device should only be set-up, installed and commissioned by MELAG authorized persons.
nThe connections for electrical provision and water supply and discharge must be set-up by trained per-
sonnel.
nUsing the optional electronic leak detector (water stop) minimizes 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 authorized 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.
nMELAtherm10Evolution DTA is disconnected from the mains via the on-site main switch.
MELAtherm10Evolution DTB disconnects from the mains by removing the mains plug from the
socket.
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 especially important to comply with the specifications from the instrument manu-
facturer regarding cleaning instruments for the first time after purchasing new instruments.
nUse only original MELAG accessories or those from other suppliers authorized for use by MELAG.
nWhen using non-MELAG accessories for the mounting of instruments (especially hollow body instru-
ments) 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
8
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, neutralizers and rinse aids contain irritants
and even caustic substances.
nComply with the safety instructions in the accompanying 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 authorized technicians.
nMaintain the specified servicing intervals.
Malfunctions
nShould the device issue the same malfunction message repeatedly, turn off the device and if neces-
sary, inform your stockist.
nThe device may only be serviced by authorized 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 deterioration 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
9
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 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 invasive thermostable instruments to automatic repro-
cessing 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 environ-
ment.
This device is NOT suitable for the reprocessing of:
uThermo-unstable instruments e.g. flexible endoscopes
uLaboratory waste requiring disposal
uCrockery
uBedpans
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 (inc. HBV, HCV). This
means that the effective 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 cleaning and disinfection. The HEPA filter guarantees drying with contamination and particle-free
air. The automatic reprocessing of hollow-body instruments is also possible. This protects the instruments
against corrosion. Manual subsequent drying is usually not necessary. The geometry of some hollow-body
instruments mean that they require additional drying.
Automatic sieve recognition
The device recognizes 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 circulation 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 performance. The device aborts a current program if too much foam is generated.

3 Performance specifications
10
Metering monitoring
The required amounts of cleaning agent and neutralizer are metered using a hose metering pump. A
measuring turbine performs flow monitoring. The rinse aid is metered using a hose pump subject to moni-
toring for rotation speed.
Drawer for process agents
The drawer for the process agents is located in the lower area of the device in which the cleaning agent,
neutralizer 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 pre-
vents protein fixing from too high a water temperature; the soiling load of the washing liquor in the follow-
ing program steps will be reduced considerably. In Intensive-Program, this step is performed twice.
Cleaning
A new water volume 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.
Neutralization
The cleaned instruments will be freed from alkali residue during neutralization. At the same time, this pre-
vents the development of acid-soluble deposits such as limescale and foreign corrosion. To this end, a
new water volume will be fed into the washing chamber, a citric acid or phosphoric acid-based neutralizer
will be metered and short circulation will be performed.
Intermediate rinsing
A new water volume is fed into the washing chamber and circulated cold. This rinses off the neutralizer
residue. In Ophthalmo-Program, 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. A new water volume, preferably DI water is fed into the washing chamber and heated. Once
the metering temperature has been reached, a rinse aid will be metered in Quick-Program, Universal-
Program and Intensive-Program. Once the disinfection temperature 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 instru-
ments 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 pro-
gram end or the end of a program abort.