MELAG MELAtherm 10 Manual de usuario
User Manual
MELAtherm® 10
Washer-Disinfector
from software version 1.311
EN
Dear doctor,
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
management system is subject to close monitoring: one instrument to this end is our annual multi-day audit conducted in
accordance with ISO13485. 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
Approved process agents ..................................................................................................................................................10
4 Description of the device...................................................................................................................................................12
Scope of delivery................................................................................................................................................................12
Views of the device ............................................................................................................................................................13
Symbols on the device.......................................................................................................................................................15
Operating panel and acoustic signals ................................................................................................................................16
Menu structure ...................................................................................................................................................................17
Water softening unit ...........................................................................................................................................................18
5 First steps ...........................................................................................................................................................................19
Setup and installation.........................................................................................................................................................19
Switching the device on and off .........................................................................................................................................19
Opening and closing the door ............................................................................................................................................19
Manual door emergency-opening ......................................................................................................................................20
Inserting the basis basket ..................................................................................................................................................21
Filling the regeneration salt................................................................................................................................................21
Regenerating the water softening unit ...............................................................................................................................22
Metering process agents....................................................................................................................................................23
Holding process agents ready............................................................................................................................................23
Removing air from the metering system ............................................................................................................................26
6 Cleaning and disinfection..................................................................................................................................................27
The type of load .................................................................................................................................................................27
Arranging the load..............................................................................................................................................................27
Decontaminating hollow-body instruments ........................................................................................................................28
Decontaminating dental transmission instruments.............................................................................................................29
Decontaminating ophthalmological instruments.................................................................................................................29
Overview of programs........................................................................................................................................................31
Selecting, starting and following the program ....................................................................................................................32
Manual program abort........................................................................................................................................................33
Removing the load after program end................................................................................................................................34
7 Logging ...............................................................................................................................................................................36
Batch documentation .........................................................................................................................................................36
Output media......................................................................................................................................................................36
Outputting logs immediately and automatically..................................................................................................................37
Subsequent log output .......................................................................................................................................................38
Contents
Deleting the saved logs......................................................................................................................................................39
Determining the format for the program logs .....................................................................................................................39
Finding the logs..................................................................................................................................................................42
8 Settings ...............................................................................................................................................................................43
SETUP MENU....................................................................................................................................................................43
Setting the water supply.....................................................................................................................................................43
Setting automatic logging...................................................................................................................................................43
Setting date and time .........................................................................................................................................................44
Setting the display contrast................................................................................................................................................45
Selecting the language.......................................................................................................................................................46
Setting the water hardness ................................................................................................................................................46
9 Function tests.....................................................................................................................................................................47
Automatic and manual functional check.............................................................................................................................47
Measuring conductivity.......................................................................................................................................................47
10 Maintenance......................................................................................................................................................................48
Regular checks and cleaning.............................................................................................................................................48
Cleaning on demand..........................................................................................................................................................50
Avoiding staining................................................................................................................................................................50
Changing the filter in the drying fan ...................................................................................................................................51
Maintenance.......................................................................................................................................................................52
(Process) Validation...........................................................................................................................................................52
11 Pause times ......................................................................................................................................................................53
Decommissioning...............................................................................................................................................................53
Transport within the practice..............................................................................................................................................54
12 Malfunctions .....................................................................................................................................................................55
General events...................................................................................................................................................................56
Warnings............................................................................................................................................................................57
Malfunction messages .......................................................................................................................................................62
13 Technical data ..................................................................................................................................................................70
14 Accessories ......................................................................................................................................................................72
15 Documentation and approval..........................................................................................................................................73
Glossary .................................................................................................................................................................................74
1 General guidelines
5
1 General guidelines
Please read this user manual carefully before commissioning the device. The user manual includes impor-
tant safety information. The functionality and value-retention of this device depends on the care accorded
to it. Please store these user manual carefully and in close proximity to your device. It represents a compo-
nent of the product.
Should the user manual no longer be legible, damaged or lost, please 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.
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
selected for their environmentally-friendly disposability and can be recycled. Returning the packaging to
the material flow reduces the amount of waste and saves raw materials. Dispose of 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
6
2 Safety
When operating the device, please ensure that you observe the following safety
instructions as well as those contained in the following 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.
Set-up, installation and commissioning
nCheck the device for any damage suffered during transport after unpacking.
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
personnel.
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
1.5m 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.
Daily operation
nUse only those instruments designed by their manufacturer for automatic reprocessing in a washer-
disinfector. Comply with the instructions issued by the instrument manufacturer in accordance with
DINENISO17664. It is especially important to observe the manufacturer's information regarding
cleaning instruments for the first time whilst 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 manufacturer’s information.
nComply with the specifications of the national standards pertaining to the decontamination of instru-
ments and directives, the manufacturer’s decontamination instructions and those from the AKI.
nInstrument decontamination may only be performed by trained personnel.
nThe fore ventilation slits may not be covered.
2 Safety
7
nOnly ever operate the device using with the basis basket provided for this purpose.
nNever operate the device unattended. Unsupervised operation of the device can result in damage to
the device or your facility. In such a case, MELAG does not accept any liability.
Process agents
nHandle all process agents with care. The cleaning, neutralization and rinsing aids contain irritants and
even caustic substances.
nUse only those process agents approved by MELAG for this device. Observe the operating and safety
information from the process agent manufacturer. If, despite observation of the manufacturer's infor-
mation, the process agents have a negative effect on the material of the instruments or the device,
liability lies with the manufacturer of the process agents.
nThe use of process agents not approved by MELAG absolves MELAG of all liability whatsoever for
any damage to the device or the instruments.
nShould you have any questions concerning the compatibility of the process agents with the instru-
ments, please consult the manufacturer. MELAG provides information for the application of the
process agents in the device but does not take any responsibility for their effects on the instruments.
nAny fluids in the drawer and the floor tank underneath can also contain process agents in case of
damage. Ensure that you observe the information of the respective process agent manufacturer.
Transport and storage
nStore and transport the device in a frost-free environment.
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 necessary, inform your stockist.
nThe device may only be serviced by authorized technicians.
3 Performance specifications
8
3 Performance specifications
Intended use
In accordance with DIN EN ISO 15883-1 and -2, this device is a washer-disinfector intended for use in a
medical context such as clinics and medical and dental practices. You can subject thermostable medical
instruments (i.e. instruments which are heat resistant to a temperature of 95 °C) to automatic reprocessing
as long as they are suitable for this purpose and have been approved for such treatment by their manufac-
turer. The cleaning is undertaken via the use of water and a chemical cleaning agent. Subsequent disin-
fection is thermal disinfection. This device is not intended to be used in a patient environment.
This device is NOT suitable for the decontamination of:
▪ Thermo-unstable instruments e.g. flexible endoscopes
▪ Laboratory waste requiring disposal
▪ Crockery
▪ 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 is achieved. This kills vegetative bacteria, fungi and their spores and viruses (inc. HBV, HCV)
so 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 additionally fitted HEPA filter guarantees drying with contamination-
free air. The automatic decontamination of hollow body instruments is also possible. This protects the
instruments from stain accretion and rusting. The geometry of some hollow body instruments mean that
they require additional drying.
Automatic filter recognition
The device recognizes 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 decontamination results.
Monitoring the speed of the rinse arm
The rotation speed of the rinse arms is subject to permanent monitoring during a program run. This en-
sures 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 the program run. This ensures an effective
cleaning performance. The device aborts a current program if too much foam is generated.
3 Performance specifications
9
Metering monitoring
The required amounts of cleaning agent and neutralizer are measured out using a hose metering pump. A
measurement turbine performs flow monitoring. The rinse aid is metered using a hose pump subject to
monitoring 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 is subject to automatic internal con-
ductivity measurement.
Manual door emergency-opening
The door can be opened manually in an emergency via the emergency opening following a power outage
or malfunction.
Program sequence
The following program steps are indicated on the display during the program run.
Pre-cleaning
Pre-cleaning is performed with cold (min. 22 °C), softened or de-ionized water without process agents.
Instrument soiling and contamination (proteins and/or coarse organic deposits) will be mechanically
removed to avoid denaturation from excessively-high water temperatures.
Cleaning
The pre-cleaning is followed by the actual cleaning phase with warm process water and the addition of a
mildly-alkaline cleaning agent. As part of the cleaning process, a defined volume of process water is let
into the washing chamber and heated to 40 °C. The mildly-alkaline cleaning agent is automatically
metered to the process water as soon as the set temperature has been reached. The temperature is main-
tained (holding time). This is followed by the actual cleaning.
The process water is heated further for the actual cleaning process. Any soiling or organic deposits still on
the instruments are removed at a temperature of 55 °C.
Neutralization
The main wash is followed immediately by neutralization. Neutralization reduces the alkalinity introduced
during cleaning and removes acid-soluble deposits such as limescale and extraneous rust etc.
A metered amount of neutralizer is added during this phase. The neutralized process water is subject to
continual circulation for a defined period. Finally, the process water is pumped out of the washing chamber
completely.
Intermediate rinsing
Intermediate rinsing is the preparatory step for thermal disinfection in which the instruments are rinsed
without process agents. The rinsing serve to reduce the residual process agents to a defensible level. In
this phase, a metered amount of cold process water is let into the washing chamber and subject to con-
tinual circulation for a defined period. Finally, the process water is pumped out of the washing chamber.
Disinfection
The actual disinfection is performed after intermediate rinsing. The disinfectant effect of MELAtherm 10 is
achieved using thermal disinfection and subsequent drying.
A rinse aid added to the process water at a temperature of 70 °C. The actual thermal disinfection is per-
formed via continual circulation and heating of the process water to 90 °C and a holding time at this tem-
perature of min. five minutes. Following the disinfection, the process water is pumped out of the washing
chamber completely.
3 Performance specifications
10
Drying
Drying is effected by drawing ambient air through a class H 13 HEPA filter. The instruments are dried
inside and out with hot, filtered air. This prevents rust accretion on the instruments.
Displaying the batch counter
The display shows the last batch number run and the total batch counter after a program end or the end of
a program abort.
Approved process agents
NOTICE
Only use process agents of the same manufacturer. Process agents from different
manufacturers may not be mixed. Any change to another authorized combination may
only be performed by trained service technicians. The metering concentration must be
adapted to local conditions. This is to be performed by the service technician during
setup in accordance with the manufacturer's information.
NOTICE
Observe the operating and safety information from the process agent manufacturer. If,
despite observation of the manufacturer's information, the process agents have a
negative effect on the material of the instruments or the device, liability lies with the
manufacturer of the process agents. The use of process agents not approved by MELAG
absolves MELAG of all liability whatsoever for any damage to the device or the
instruments.
The following combinations of process agents were tested for suitability for use with devices (compatibility
with material of the components) brought into circulation on or after 1.7.2012:
Manufacturer Cleaning agent Neutralizer Rinse aid
MELAG MEtherm 50 - Mildly-alkaline
cleaning agent
MEtherm 55 - Neutralizer C
MEtherm 56 - Neutralizer P
MEtherm 60 - Rinse aid
MEtherm 61 - Rinse aid
Alpro TR-3 TR-Neutralizer TR-Clear
B. Braun Helimatic cleaner alkaline Helimatic neutralizer C Helimatic rinse neutral
Bode Dismoclean 21 clean Dismoclean 25 acid Dismoclean 64
neutra-dry
Borer deconex 28 ALKA ONE-x
deconex 22 LIQ-x
deconex 25 ORGANACID
deconex 26 MINERALACID
deconex 64 NEUTRADRY
Dr. Schumacher Thermoton Cleaner Thermoton N Thermoton clear
Dr. Weigert neodisher MediClean forte
neodisher MediClean Dental
neodisher N
neodisher Z
neodisher N dental
neodisher Z dental
neodisher MediKlar
neodisher MediKlar dental
neodisher MediKlar
special
Schülke & Mayr thermodent alka clean
thermosept RKF
thermosept alka clean forte
thermosept Xtra
thermodent neutralizer
thermosept NKP
thermosept NKZ
Thermodent clear
Thermosept BSK
Henry Schein Eurosept Thermo Cleanser
Eurosept Plus Thermo
Cleanser
Eurosept Thermo Neutralizer
Eurosept Plus Thermo
Neutralizer
Eurosept Thermo Rinse
Eurosept Plus Thermo
Rinse
Otros manuales para MELAtherm 10
7
Tabla de contenidos
Otros manuales de Arandela de MELAG
