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User Manual

®
MELAtherm 10
Washer-Disinfector
Software version 1.309

Dear Dr.

We should like to extend our thanks for the expression of trust in our company which you have displayed through 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 systems is subject to close monitoring: one instrument to this end is our annual multi-day audit conducted
in accordance with ISO 13485 and ISO 9001 conducted by the certification agency BSI. This guarantees that all MELAG
products are manufactured and tested in accordance with strict quality criteria.

The MELAG management and team.


General Guidelines
Please read this User Manual before you start operation of the device. The manual contains important safety information.
The functionality and value-retention of this autoclave depend on the care accorded to it.
Make sure to keep the User Manual close to the device. It represents a component of the product.

User Group
This manual is targeted at doctors, medical assistants and service.

Validity
This manual applies to the devices MELAtherm 10 DTA and MELAtherm 10 DTB.

About these Instructions


Symbols used
Symbol Explanation
Indicates a dangerous situation which if not avoided could entail slight to life-threatening
injuries.
Indicates a dangerous situation which if not avoided could entail damage to the
instruments, the practice equipment or the device.
Draws your attention to important information.

Marking rules
Symbol Explanation
→HEPA filter Words or phrases marked with an arrow are explained in the glossary. The glossary is
listed alphabetically. It can be found at the end of this manual.
Cleaning Words or phrases appearing on the display of the device are marked as display text.
see Chapter 2 Reference to another text section or a figure within this manual.

Symbols on the device


Symbol Explanation
In affixing the CE mark, the manufacturer declares that this medical product fulfils the
basic requirements of the medical products directive. The four-digit number confirms that
this is monitored by an approved certification agency.
The symbol of the crossed out waste bin identifies a device that must not be disposed in
domestic waste. The vendor is responsible for proper and professional disposal.
By the designation of an apparatus with this symbol, the manufacturer furthermore
declares that he satisfies all requirements of the law concerning the release, redemption
and environmentally sound disposal of electric and electronic appliances.
Contents

Contents
Chapter 1 – Performance Specifications .........6 Chapter 5 – Logging ..................................... 31
Proper use ................................................................... 6 Batch documentation ................................................. 31
User benefits ............................................................... 6 Using the CF card as an output medium .................... 32
Computer as output medium ...................................... 33
Chapter 2 – Device Description.......................8 Log printer as issue medium ...................................... 33
Views of the device ...................................................... 9
Automatic immediate log output ................................. 34
The control panel ........................................................11
Output the logs subsequently ..................................... 35
Acoustic signals ..........................................................11
Determining the format for the program log ............... 35
Overview of menus .....................................................12
Finding Logs .............................................................. 39
Automatic door lock ....................................................13
Emergency release .....................................................13 Chapter 6 – Settings ..................................... 40
Water softening unit ....................................................14 Opening the setup menu ............................................ 40
Water supply .............................................................. 40
Chapter 3 – Initial Commissioning ................. 15 Automatic logging....................................................... 41
Conditions for setting up, installing and starting up ....15
Date and time ............................................................. 41
Requirements to the set-up location ...........................15
Display contrast ......................................................... 42
Set-up variations .........................................................16
Language ................................................................... 43
Space requirements....................................................16
Water hardness .......................................................... 43
Connections required..................................................17
Filling the regeneration salt.........................................17 Chapter 7 – Function Test ............................ 44
Regeneration ..............................................................18 Automatic function test ............................................... 44
Process agents ...........................................................18 Manual function test ................................................... 44
Filling the cleaning agent ............................................19 Testing in daily operation ........................................... 44
Filling the neutralizer...................................................19 Measuring conductivity............................................... 44
Filling the rinse aid ......................................................20
Chapter 8 – Maintenance ............................. 45
Bleeding the metering hoses ......................................20
Daily inspection/cleaning............................................ 45
Metering......................................................................21
Cleaning on demand .................................................. 46
Switching on the device ..............................................21
Changing the HEPA filter in the drying fan ................. 47
Preconditions for commissioning ................................21
Avoid formation of spots............................................. 48
Record of installation and setting up ...........................21
Maintenance .............................................................. 48
Chapter 4 – Cleaning and Disinfection .......... 22 (Process) validation.................................................... 48
The nature of the load.................................................22
Chapter 9 – Operating Pauses ..................... 49
Hollow bodied instruments..........................................22
Pause times ............................................................... 49
Dental transfer instruments.........................................23
Shut-down .................................................................. 49
Ophthalmologic instruments .......................................23
Transport.................................................................... 49
Arranging the load ......................................................25
Re-commissioning after change of locality ................. 50
Observe before the program start ...............................26
Closing the door .........................................................26 Chapter 10 – Errors ...................................... 51
Selecting the program.................................................26 Before you call ........................................................... 51
Starting the program ...................................................27
Appendix A - Accessories ............................. 57
Program run................................................................27
Program ended ...........................................................28 Technical Data ............................................. 58
Manual program termination .......................................29
Removing the load ......................................................30 Glossary ....................................................... 59
Chapter 1 – Performance Specifications

Safety Instructions
When operating the device, please ensure that you observe the following safety instructions as well as
those contained in the following chapters.

Purpose
 Use the device only for the purpose named in the user manual.

Power cable and mains socket


 All legal specifications and electrical operating conditions of the local electricity provider must be
complied with completely.
 Never damage or alter the plug or mains cable.
 Never operate the device if the mains cable or power plug are damaged.
 Never unplug by pulling on the power cable. Always grip the plug itself.

Set-up installation and commissioning


 Only have the device set up, installed, and started up by people →authorised by MELAG.
 Check the device for any damage suffered during transport after unpacking.
 Only operate the device in areas that are not subject to explosion hazards.
 The connections for electrical provision and water supply and discharge must be set-up by trained
personnel.

Daily operation
 Use only those instruments designed by their manufacturer for automatic treatment in a washer
disinfector. Please ensure that you observe the information provided by the instrument
manufacturers according to ISO 17664. It is especially important to observe the manufacturer's
information when treating newly purchased instruments for the first time.
 Use only original MELAG accessories or those from other suppliers authorized for use by
MELAG.
 When using additional accessories to accept instruments, especially hollow-bodied instruments, it
is necessary to observe the information contained in the manufacturer's operating instructions.
 Observe the relevant standards and directives applicable to the treatment of instruments e.g. from
the →RKI, →BfArM, →DGSV, →DGKH etc. as well as the treatment information from the
instrument manufacturer and the →AKI.
 The personnel responsible for instrument treatment must be sufficiently trained and schooled.
 The fore ventilation slits must not be covered.
 Only operate the device with the basis basket provided for this purpose.

Process agents
 Handle all process agents with care. The cleaning, neutralization and rinsing aids contain irritants
and even caustic substances.
 Use only those process agents cleared for use in a washer-disinfector and which MELAG has
approved for use in this device. Observe the operating and safety information of 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.
 Should you have any questions concerning the compatibility of the process agents with the
instruments, 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.
 Any 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.

Maintenance
 Have the maintenance performed only by →authorised persons.

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Chapter 1 – Performance Specifications

Transport and storage


 Install and operate the device in a frost-free environment. Store and transport the device in a
generally frost-free environment.

Malfunctions
 If repeated error messages occur while operating the device, turn the device off and notify your
specialist dealer.
 Only have the device repaired by →authorised persons.

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Chapter 1 – Performance Specifications

Chapter 1 – Performance Specifications


In this chapter you learn
 The purpose for which you can employ the device
 What benefit you can achieve by using it
 The cleaning programs that are available

Proper use
This device is designed for application in a medical context, e.g. clinics and medical and dental practices.
In accordance with DIN EN ISO 15883-1 and -2, this device is a washer-disinfector. You can subject
thermo-stable medical instruments (i.e. instruments which are heat resistant to a temperature of 95 °C) to
automatic cleaning as long as they are suitable for this purpose.
The cleaning is undertaken via the use of water and a chemical cleaning agent.
Subsequent disinfection is performed by thermal disinfection.

This device is not suitable for treatment of:


 Thermo-instable instruments, e.g. flexible endoscopes
 Wastes for disposal and in the lab area

User benefits
Universal use
The device cleans and disinfects. The disinfection phase is conceived so as to reach an A0 value of at
least 3000. This eliminates vegetative bacteria and fungi/fungal spores and disables viruses (inc. HBV,
HCV) thus reaching the effective range AB according to the RKI directive.

Active drying
The device has an active drying facility. This means that after cleaning and disinfection, the instruments
are dried inside (interior lumen) and out via an integrated drying fan. This enables the automatic treatment
of hollow-bodied instruments such as suction cannulas. This protects the instruments from stain accretion
and rusting.
The additionally fitted →HEPA filter guarantees drying with →contamination-free air.
The geometry of some hollow-bodied instruments such as turbines requires additional drying.

Automatic filter recognition


The device recognizes automatically that the fine filter has not been inserted in the base of the washing
chamber before starting. Thus it avoids a situation in which instrument components enter the opening of
the outflow pump or the circulation pump and thus restricting the function of the pumps, rinse arms and the
injector rails.

Internal water softening


The device has an internal softening plant. The water hardness of the local drinking water is set in the
device. The internal water softening unit then automatically adjusts itself to the best solution. This ensures
the optimal rinsing of chlorides.

Monitoring the rotation speed of the rinse arms


The rotation speed of the lower and upper 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 cleaning pressure


The cleaning pressure is monitored during a program run via a pressure sensor. This ensures effective
cleaning. Excess foam generation results in the interruption of the program run.

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Chapter 1 – Performance Specifications

Metering monitoring
The required amounts of cleaning agent and neutralizer are measured out using a hose measuring pump.
A measurement turbine performs flow monitoring. The rinse aid is metered using a hose metering pump
subject to monitoring for rotation speed.

Drawer for process agents


The drawer in the lower area of the device provides storage space for the process agents cleaning agent,
neutralizer and rinse aid.

Automatic conductivity measurement


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

CF card, Ethernet
An integrated CF card slot and Ethernet interface enable secure and easy documentation of the entire
cleaning and disinfection process. This is an important precondition for the clearance process. This
enables the transfer of data from the device to your practice computer.

Display
A program can be started and settings undertaken via the two-line display with four operating keys.

Motorized door lock


The device is equipped with a comfortable locking mechanism which locks the door with an automatic door
lock with a motorized lock.

Emergency release
The door can be opened manually in the case of a loss of power or malfunction using the emergency
release.

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Chapter 2 – Device Description

Chapter 2 – Device Description


In this chapter you learn
 Which components are included in the scope of delivery
 What components the device contains
 What safety devices the device has
 How the operating elements are designed and how you should use them

Scope of delivery
Standard scope of delivery
 Washer-disinfector MELAtherm 10
 User Manual
 Technical Manual
 Record of installation and setting up
 Declaration of conformity
 1 Container, 5 l
 1 container for rinse aid, 1 l
 1 feed funnel for the regeneration salt
 1 starter package of regeneration salt

Optionally
 Stainless steel cover plate (HxWxD 1.8 cm x 59.8 cm x 59.8 cm)
 Floor unit (HxWxD 40 cm x 59.8 cm x 49.8 cm)

Accessories
 According to order

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Chapter 2 – Device Description

Views of the device


Front side
1. Cover plate (optional)
2. Operating and display field
3. Mains switch
4. Cover for CF card slot and Ethernet data
interface
5. Door handle
6. Door, can be opened forwards

7. Drawer handle
8. Drawer for process agents, can be pulled
out
9. Device front feet

Back side

10. Ethernet-Data connection (rear)


11. Mains power cable

12. Connection for de-ionised water


(DI water)
13. Connection for cold water (CW)
14. Effluent connection
15. Transport rollers

Fig. 1: Views of the device

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Chapter 2 – Device Description

Interior view

16. Connection tube for injector rails


17. Water intake cold water (CW) + DI water
18. Salt container
19. Rinse arm
20. Coarse and fine filter
21. Cooling slot (air outlet with active drying)

Fig. 2: Interior view

10
Chapter 2 – Device Description

The control panel


The control panel consists of a two-line alphanumerical LED display and four membrane keys.

Keys 1 2 3 4

Key When to be used? Function/Explanation


e.g. program Takes precedence over navigation BACKWARDS - FORWARDS,
selection to adjust a value: SMALLER - LARGER

To unlock the door or


BACKWARDS, CANCEL, leave menu
ENTER, OK, YES, SELECT, QUIT upon warning or error message

In all display images The system status is constantly displayed in 8 further display
images with information relating to the device e.g. serial number,
software version, daily and total batches etc.
after program QUIT + DOOR, i.e. to clear the program interruption and
interruption unlock the door
in the DOCU menu To delete all logs located in the internal log memory

In Universal-Program Only for technicians (validation mode)

Only for technicians (maintenance mode)

Acoustic signals
The device emits acoustic signals. The signals are designed to attract your attention and serve to inform
the operator. With consecutive signals, the time between two signals amounts to 0.5 seconds.

Signal Meaning
1 x 0.1 Seconds Confirms the correct operation of a key
1 x 0.5 Seconds Warning or message
3 x 0.5 Seconds At indication: Refill the salt soon;
Program interruption; end of interruption reached after interruption of drying
5 x 0.5 Seconds Program completed successfully
10 x 0.5 Seconds Fault

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Chapter 2 – Device Description

Overview of menus
MAIN MENU
├ P01 Universal-Program
├ P02 Quick-Program
├ P03 Intensive-Program
├ P04 Ophthalmo-Program:
├ Z01 Rinsing
├ Z02 Emptying
├ Z03 Reference value measurement DI
├ Z04 Air removal
├ Z05 Regeneration
├ Z06 Time metering 60s
├ M01  DOCU MENU (Output of a saved log via the following output media)
│ └ Select output medium Automatic*, CF card, MELAprint, PC
│ ├ 01 Log list
│ ├ 02 Last log
│ ├ 03 Logs of day
│ ├ 04 Logs of week
│ ├ 05 Logs of month
│ ├ 06 All logs
│ ├ 07 Last malfunction log
│ ├ 08 Malfunction logs of day
│ ├ 08 Malfunction logs of week
│ ├ 10 Malfunction logs of month
│ ├ 11 All malfunction logs
│ ├ 12 Caption log
│ ├ 12 Status log
│ ├ 14 System log
│ └ 15 Format CF card
└ M02  SETUP- MENU
├ 01 DI water
├ 02 Automatic logging
│ └
├ 03 Date
├ 04 Time
├ 05 Display contrast
├ 06 Language
├ 07 Water (hardness) °dH
└ 08 DIAGNOSIS + SERVICE
├ > AC outputs (AC-OUT)
├ > DC outputs (DC-OUT)
├ > Analogue inputs
├ > Counter inputs
├ > Digital inputs
│ SERVICE MENU
│ └
├ Maintenance Counter Date
└ DEMO mode

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Chapter 2 – Device Description

Automatic door lock


The automatic door lock guarantees the safe locking and sealing of the door during the program run. The
door is locked by a motorized lock. The device must be connected to the mains and switched on in order
to open and close the door.
1. In order to close the door of the device, raise the door and press it on firmly until it clicks. You can
let go of the door as soon as the motorized lock activates.
The door is then closed and locked automatically.

2. To open the door, press the key. This unlocks the door which now can be opened. Pull the
door forward using its handle.

NOTE
After the program has begun, the door can only be opened by interrupting the program. Clearing
the program interruption or the end of a program also opens the door.

Emergency release
The door of the device cannot be opened to remove the instruments during a power outage. In such a
case, you can activate the door emergency release. This is located on the left interior in the lower area of
the device:
1. Pull the process agent drawer out forward. A tie rod for opening the door in emergencies is
located in the left front of the device interior.
2. Press the tie rod to its fullest extent until you hear a click. Pull the door open. You will require a
little more force.

DANGER
This could release hot steam when operating the emergency unlocking mechanism. The metal
surfaces are hot.
There may be scalding or burns.
 Never operate the emergency release while a program is active.

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Chapter 2 – Device Description

Water softening unit


The device requires softened water for proper function.
Tap water over a particular hardness (4°dH) must be softened to prevent lime scale deposits on the
instruments and in the interior of the device. A water softening unit is installed to this end. Its design has
been adapted to match the requirements of the device in terms of water quality and performance.
Commercially available regeneration salt (NaCl) is used in the regeneration of the water softening unit, as
in a dish washer.

NOTE
The fitted water softening unit has been optimized for a degree of hardness of 0–40°dH. For
higher degrees of hardness, you will require a dedicated water softening unit.

WARNING
If the hardness is too high, the salt consumption will be higher. Setting too low a degree of
hardness can result in lime scale deposits on the instruments.
 When using a dedicated water softening unit, the residual hardness of the dedicated water
softening unit must also be set in the setup menu.

Table 1: 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

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Chapter 3 – Initial Commissioning

Chapter 3 – Initial Commissioning


In this chapter you learn
 Who is permitted to set up, install and start up the device
 The necessary preconditions for the set-up and installation
 The various set-up variations
 How to fill regeneration salt
 How to fill the process agents
 How to activate the device

Conditions for setting up, installing and starting up


 In accordance with current VDE specifications, the device is unsuitable for operation in areas exposed
to the danger of explosion.
 The device is conceived for use outside patient surroundings.
The device should be located at least 1.5 m away (radius) from the treatment area.
 Observe all the information contained in this chapter during commissioning.

DANGER
Improper installation may lead to a short-circuit and/or fire and/or water damage and/or
electrical shock. This could result in serious injury.
 Only have the device set up, installed, and started up by people →authorised by MELAG.

Requirements to the set-up location

Observe the following requirements:


 The site of setup is dry and dust-protected.
 The humidity is 30 – 60 %.
 The ambience temperature is 15 – 35 °C.
 There are no installations in the area of the rear of the device.

WARNING
Steam escaping from the device may cause damage to the adjacent furniture.
 During installation of the device please ensure that the adjacent base cabinets or other
furniture and fittings are resistant to condensation.

Observe the following safety measures when dealing with the cable and mains plug:
 Never splice or change the mains cable.
 Never bend or twist the mains cable.
 Never pull on the mains cable to take it out of the socket. Always take a grip on the plug.
 Never place any heavy objects on the mains cable.
 Never run the cable over areas in which it could become trapped (e.g. doors or windows).
 Never install the cable along a source of heat.
 Never use any nails, paper fasteners or similar objects to secure the cable.

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Chapter 3 – Initial Commissioning

 Should the cable or plug be damaged, switch off the device. The power cable and plug should only be
replaced by →authorised persons.
 If these points are not observed, the cable or plug can be damaged and/or a fire or electrical shock
might occur. This could result in serious injury.

Set-up variations
You can set up the device in the following manner:
 Free-standing using the optional stainless steel cover plate.
 Next to pre-existing under-desk unit in conjunction with the optional stainless steel plate.
Space requirements amount to a minimum of 60 cm in width and 60 cm depth.
 As under-desk unit in a pre-existing cavity with a work top.
 Free-standing with an additional floor unit and stainless steel cover plate (optional).

Space requirements
The under-desk unit fits into a normal 60 cm cavity next to floor-standing cupboards. The stainless steel
cover plate is not required in this instance. The device is placed under a pre-existing work top.
A C
B1
B2
B3

D
E F
G

Under-desk unit Free standing Top-frame device

Width A 59.8 cm 59.8 cm 59.8 cm

Height B B1 = 81.8 cm B2 = 83.6 cm B3 = 124 cm

Depth C 67.8 cm 67.8 cm 67.8 cm


(with display)
D 8.2 cm 8.2 cm 8.2 cm

(Without display) E 59.1 cm 59.1 cm 59.1 cm

F 28.5 cm 28.5 cm 28.5 cm

G 96.1 cm 96.1 cm 96.1 cm

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Chapter 3 – Initial Commissioning

Connections required

DANGER
Improper electrical connection may lead to a short-circuit, fire, water damage and/or
electrical shock. This could result in serious injury.
 The connections for electrical provision and water supply and discharge must be set-up by
trained personnel.
 Also observe the information on installation and commissioning in the technical manual.

Filling the regeneration salt

WARNING
Unsuitable regeneration salt can result in malfunctions of the water softening unit.
 Use only special, coarse grain regeneration salt (additive-free NaCl). Fine grain regeneration
salt can cause device malfunctions.
 We do not recommend the use of pellets, as the salt dissolves too slowly.
 Never use cooking salt, table salt, de-icing salt, cattle salt or road salt. These salts usually
contain insoluble components.
 Never pour cleaning agent or other process agents in the salt container.

The regeneration salt is fed into the salt container from the salt container during the regeneration process
automatically.
Before the regeneration salt has been used entirely, the display will issue the message Refill salt
soon at the appropriate time. A further 10 washing runs will be possible following this message, depending
on the program selected and the water hardness set.
If salt is not refilled during this period, the display will change to

Salt storage empty


Please refill!

The regeneration salt must be refilled at this point at the latest, or else an error message will be issued.
Then the program can no longer be started. In order to refill the regeneration salt, proceed as follows:

1. Clear the display message with the key.


2. Open the door and remove the load which may have been processed.
3. Open the salt container cap and place the funnel in the opening.

4. Before first commissioning, fill the salt container with water until it flows over so salt can dissolve
in it.
5. Fill the salt container with 1 kg of regenerating salt. If there is insufficient salt in the container, the
device cannot be operated.
6. Clean the edge of the opening of salt residue and any spilled brine.

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Chapter 3 – Initial Commissioning

7. Screw the cap on tightly.


After filling the salt container for the first time, you do not need to add any more water.
To achieve optimal capacity, we recommend always waiting for the display text Refill
salt to show up after program end before refilling the salt.

Also observe the following instructions on refilling the salt:


 It is possible to refill salt at any time, but the automatic regeneration will begin only after a particular
capacity is reached. As a result, it is absolutely necessary to start the additional rinse program
manually after adding salt in order to rinse away any brine or salt residue from the washing chamber.
 Salt residue left in the washing chamber after filling must be removed before rinsing.
 After refilling salt wait about 3 min. before starting a new program so that the salt can dissolve.

Regeneration
The water softening unit must be regenerated completely after specific intervals. This occurs entirely
automatically. The regeneration will be implemented before the program selected has been carried out as
soon as a program has been started and regeneration is necessary. This extends the program time only
marginally.
You can also regenerate the water softening unit manually by starting the regeneration program , for
example, after adding salt without a warning message having been displayed.

Process agents

DANGER
The process agents partially contain irritant or even corrosive substances that may cause
health damage at contact with the skin.
 Protect your eyes, hands, clothing and surfaces from contact with the process agents.
 Every type of fluid (e.g. in the drawer, in the device floor tank or fluid emerging from the
device) issued from the device as the result of damage could potentially contain aggressive
process agents.
 Ensure that you observe the information of the respective process agent manufacturer.

WARNING
Unsuitable process agents can result in damage to the instruments and the washing
chamber.
 Use only those cleaning agents intended for use with this device. Ensure that you observe the
information of the respective process agent manufacturer.
 Use only those process agents approved by MELAG.
 Do not use any domestic dishwasher cleaning agents and rinse aids!
 Never switch suction lances for the individual process agents.
 Ensure that the hoses of the suction lances do not suffer kinking or crushing.

Also observe the following instructions when using the process agents:
 When re-filling, please use the same process agents, set on the device during installation (see the tie-
on label on the can in the drawer).
 Any change in process agent in a validated device during daily operation necessitates revalidation.
 The product must only be changed by a trained and authorised service technician.

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Chapter 3 – Initial Commissioning

Always place the canister in the drawer in such a way that the lids with the suction lances face forwards.

Filling the cleaning agent


Use mild alkali cleaning agents wherever possible on technical, hygienic and ecological reasons.
A 5 litre canister is provided for use with the device. Only this fits in the lower drawer of the device and can
be sealed by the blue screw cap and suction lance.
Procedure for replacing the empty can:
1. Unscrew the suction lance from the empty canister and place it in its bracket.

2. Empty any residual contents into the new canister. Do not over-fill the new canister so that the
cleaning agent is not displaced when screwing the suction lance back on.
3. Screw the relevant suction lance for the cleaning agent to the full canister.
Insufficient levels of cleaning agent trigger a message on the display indicating the necessity of
replacement.

IMPORTANT!
The metering hoses should be bleeded before commissioning (or change of product), see
Bleeding the metering hoses.

Filling the neutralizer


In addition to neutralizing the cleaning agent, the neutralizer serves to protect the instruments and
brightens their stainless steel surface.
Insufficient levels of neutralizer triggers a message on the display indicating the necessity of replacement.
A 5 litre canister is provided for use with the device. Only this fits in the lower drawer of the device and can
be sealed with the red screw cap and suction lance.
Procedure for replacing the empty can:
1. Unscrew the suction lance from the canister and place it in its bracket.
2. Empty any residual contents into the new canister. Do not over-fill the new canister so that the
neutralizer is not displaced when screwing the suction lance back on.
3. Screw the relevant suction lance for the neutralizer on the canister.
Insufficient levels of neutralizer triggers a message on the display indicating the necessity of
replacement of the cleaner.

19
Chapter 3 – Initial Commissioning

IMPORTANT!
The metering hoses should be bleeded before commissioning (or change of product), see
Bleeding the metering hoses.

Filling the rinse aid


The rinse aid serves to rinse the instruments before drying. The rinse aid dries the →load faster and
without stain accretion.

IMPORTANT!
Check that your instruments are compatible for use with rinse aid.

Procedure to fill the 1 litre container:


1. Unscrew the suction lance from the empty container.
2. Transfer the rinse aid from the original packaging into the MELAG 1 litre container. To ease this
process, you can order a transfer spigot from MELAG
3. Screw the relevant suction lance for the rinse aid onto the container.
Insufficient levels of rinse aid triggers a message on the display indicating the necessity of replacement.

If the instrument surfaces are streaky this could be caused by too much rinse aid.

IMPORTANT!
The metering hoses should be bleeded before commissioning (or change of product), see
Bleeding the metering hoses.

Bleeding the metering hoses


The process agent hoses need to be bleeded after filling the canister for the first time or changing a
product, in order to remove any air bubbles from the metering hoses, thus guaranteeing orderly metering.
To do so, start the “Air removal“ program after filling or changing the process agents:
1. Switch on the device at the mains switch.

2. Push the key repeatedly to navigate to Z04 Air removal in the main menu.

3. Start by the program "Air removal" by pushing the key .

Z04 DOOR 3
Air Removal

20
Chapter 3 – Initial Commissioning

Also observe the following notes:


 After first filling, the program "Air removal" must be started twice.
 If not all the process agents are to be used (e.g. no rinse aid), the free suction lance must be placed
head first in the free suction lance bracket before program start (only during the program "Air
removal")!

Metering
The concentration of the process agent is set once during the initial device setup performed by the
customer services technician (see technical manual). After this, metering is performed automatically.
During a program run, the preset concentration of the relevant process agents is metered automatically.

Switching on the device


Activate the device at the mains switch.

Preconditions for commissioning

The following requirements must be fulfilled for first commissioning:


 Water treatment unit is connected.
 The salt container contains sufficient salt.
 The cold water tap is open.
 The device main switch is on.
 The Regeneration program has been started.
 The process agents have been filled.
 The metering hoses have been bleeded.
 The metering has been checked in terms of the rate of supply.
 The basis basket is in place.

Record of installation and setting up


As documentation of proper setting up, installation and setting up as well as for your warranty claim, the
record of installation must be filled out by the person responsible and a copy sent to MELAG.

21
Chapter 4 – Cleaning and Disinfection

Chapter 4 – Cleaning and Disinfection


In this chapter you learn
 What you must be aware of when preparing the load
 How to load the device correctly/arranging the load
 Which program serves which purpose
 How you start a program
 Which stages a program runs through
 How to cancel a program
 How to recognize that a program has been successfully ended
 What you must observe when removing the load

The nature of the load


You can use the device to clean and disinfect that following contents in the →load.
 Massive instruments up to max. 10 kg
 Hollow articles e.g. suction cannulas which can be fixed to the hollow body nozzles or transfer
instruments, e.g. hand pieces using the adapter.

Hollow bodied instruments


Use only the respective matching adapters for hoses and Luer systems from the accessories range of
MELAG for treatment of hollow bodied instruments. They are screwed onto the injector rail and thus
ensure a secure connection to the instrument and sufficient flushing.

PLEASE NOTE
To ensure faultless function when using three-way distributors / an injector rail, all those openings
not connected to an accessory piece must be sealed with a sealing screw.
Treat only those hollow-bodied instruments which guarantee sufficient and reproducible rinsing.

PLEASE NOTE
Ensure that the liquor used to rinse hollow instruments is secured with a filter. The reusable filter
with the Order-No. 80350 may NOT be used in the treatment of ophthalmic instruments.

Rule for use of filters or filter discs:

Diameter of the inner lumen Insert of a filter

≤ 0.8 mm Filter necessary, e.g. three-way distributor with filter disc


> 0.8 mm no filter necessary, direct connection of the adapter to the injector
rail possible
When treating dental and ophthalmologic transfer instrument, observe and comply with the special
treatment notes contained in the following sections.

22
Chapter 4 – Cleaning and Disinfection

Dental transfer instruments

WARNING
In the case of damage or alteration to the hand pieces despite having observed the
manufacturer instructions, the responsibility lies with the instrument manufacturer.
 Use only those turbines and hand pieces designed by their manufacturer for automatic
treatment in a washer-disinfector. Please ensure that you observe the information provided by
the instrument manufacturers.

Suitable program
The cleaning and disinfection of hand pieces in this device must be undertaken in the Universal-Program
or the Intensive-Program.
The Quick-Program is not approved for treatment, since contamination inside cannot be assessed.

The following points must be observed before starting automatic treatment:


 The exterior surfaces of the hand pieces must be free of all residue e.g. dental cement.
 The air and spray channels must be entirely clear.
 Prevent dirt from drying or encrusting on and in the hand pieces.

Suitable process agents


Cleaning must be undertaken with a mildly alkali cleaning agent. Neutralization should be effected with a
citric acid based neutralizer.
Cleaning the adapter for the transfer instruments
The adapter for hand pieces must be checked for dirt at regular intervals. Clean the individual adapter
components under running water where necessary. The silicon inserts can be rubbed with a damp, non-
fuzzing cloth.
When using a filter insert, observe the cleaning or exchange intervals in the separate application notes for
the MELAtherm accessories.

Instrument care
Leading manufacturers recommend drying the spray/air/water channels immediately after cleaning and
disinfection using medical compressed air and then maintenance with suitable maintenance agents/oils.
Please observe all relevant national specifications.

PLEASE NOTE
Do not leave the instruments in the washing chamber overnight. Soiling can become encrusted
even after a rinsing program; this could result in instrument corrosion.

Ophthalmologic instruments

WARNING
In the case of damage or alteration to the instruments despite having observed the
manufacturer instructions, the responsibility lies with the instrument manufacturer.
 Use only those instruments designed by their manufacturer for automatic treatment in a
washer disinfector. Please ensure that you observe the information provided by the instrument
manufacturers.
 Do not treat any instruments which are used for operations of the posterior segment surgery
(contact with retinal tissue, sub-retinal fluid and the optical nerve).
 Devices used to treat ophthalmologic instruments may only be used exclusively for this
purpose. These devices are to be fitted with a suitable filter system.

23
Chapter 4 – Cleaning and Disinfection

Please comply with national recommendations for the cleaning of medical products
under the aspect of decontamination of infectious prion proteins (vCJK).

NOTE
The treatment of ophthalmologic instruments requires de-ionised water e.g. by connecting the ion
exchanger cartridge MELAdem 53.

Suitable program
Cleaning and disinfecting ophthalmologic instruments in this device requires the Ophthalmo-Program. The
Ophthalmo-Program monitors the conductivity of the water from the final rinse in the disinfection phase.
This ensures a defensible residual conductivity.
The following points must be observed with automatic treatment:
 All hollow-bodied instruments should be rinsed using DI water and checked for passage following
patient use / before automatic treatment. Instruments with recognizably reduced through-flow must be
separated.
 All hollow-bodied instruments should be connected with the rinse bar designed for the purpose.
 When using a rinsing system, individual outlets which are not connected must also be sealed with
suitable accessories.
 Ensure that plugs and / or cables from phaco hand pieces are not able to slip through the basis
basket, otherwise the rinse arm can become blocked.
 Prevent dirt from drying or encrusting on and in the instruments.
 Dry the hollow articles with medical compressed air after treatment in order to remove any residual
dampness.

Load
Using the device in combination with a basis basket and an injector rail enables you to treat hollow articles.
You will require additional accessories to treat ophthalmologic instruments, (not available from MELAG).
The operator is responsible for validating the procedure in combination with special load accessories.
Especial attention is to be accorded to the feed line to the hollow-bodied instruments.
Observe the manufacturer's instructions regarding the care and maintenance of the instruments/the load
accessories.

IMPORTANT!
Cleaning should be undertaken with a mildly alkali cleaning agent. Neutralization should be
effected with a citric acid based neutralizer. Never use a rinse aid.

Routine checks
Treatment should be followed up by blowing through the hollow articles resting on indicator paper (e.g.
from Macherey-Nagel: PEHANON ph 4.0-9.0) so as to effect a routine pH value check. The indicator paper
must be graduated in steps of 0.5 pH or less.
In Germany, the "AK Quality: Automatic Treatment of ophthalmic instruments 2005" recommends a pH
value of 5-7.
Please observe all relevant national specifications.
Pause times
Run the "rinse" program twice before treatment following pause times longer than two days e.g. following a
weekend.

24
Chapter 4 – Cleaning and Disinfection

Arranging the load

DANGER
Charging of sharp or pointy instruments may cause injuries at improper procedures.
 Take care when arranging sharp and pointed instruments and do so in a manner that prevents
all danger of injury. Loading should best be performed from back to front. We recommend
wearing protective gloves.
 Baskets and perforated cartridges with wire meshes or other openings do not provide any
protection against penetration by sharp instruments.

To arrange the load, the basis basket should be used as a minimum. This is available with an additional
injector rail for treating hollow bodied instruments.
Other accessories such as an insert rack, and instrument basket, wash trays and perforated cartridges and
instruments are always to be placed in the basis basket.
The basic basket is correctly inserted into the washing chamber when the blind flap or the injector rail is
located on the right side and docked to the connection tube of the rear wall of the washing chamber.

Fig. 3: Look into the washing chamber.

Further accessories and their user instructions such as insert rack for washing trays,
perforated cartridges and instrument baskets etc. are listed in the separate application
notes for the accessories.

Observe the following instructions when classifying the load:


 Empty residual liquids from containers before placing them in the cleaner and wash away any critical
fluids e.g. disinfection solutions.
 Individual instruments must be placed in baskets or trays and never in the basis basket directly.
 Instruments may not be allowed to protrude from the sides of the instrument basket. Otherwise, these
could damage the door seal or side walls of the washing chamber.
 Instruments may not be allowed to hang through the bars of the basket at the base. Otherwise, the
surface of the door could become scratched or parts of instruments could break off.
 Hollow-bodied instruments must be placed in the device so that secure flushing is warranted. If
required, use accessories developed specially for processing of hollow-bodied instruments, e.g.
injector nozzles, Luer connections, etc. See separate application notes for the MELAtherm
accessories.
 Transfer instruments must be set on one of the adapters with silicone insert.
 The rinse arms must be allowed to revolve freely and may not be blocked by protruding or hanging
instruments.
 A good cleaning outcome depends on the correct arrangement of the instruments. Spray shadows are
thus to be avoided.
 Instruments may not be allowed to cover each other.
 All containers such as glasses, basins etc. should be arranged with their opening pointing downwards.
 Components with openings or compressions should be arranged at an angle, so that the water can
run off them.

25
Chapter 4 – Cleaning and Disinfection

 Use only cleanable instruments made of instrument steel in order to avoid corrosion.
 Use plastic components with thermostability up to 95°C.

Observe before the program start

Ensure compliance with the following prerequisites in order to secure the optimal cleaning performance
before every program start.
 The nozzles of the upper and lower rinse arms must be freely accessible and clean (see Chapter
7 – Function Test).
 The →load must be arranged correctly.
 The rinse arms can be turned freely. For reasons for safety, the speed is monitored continually
during the program course.
 The coarse and fine filter is clean or was cleaned on demand.
 The nozzles and adapter of the injector rail must be clean (see Chapter 7 – Function Test).
 The canister with the process agents must be sufficiently full; a warning message could be issued
before the program start indicating the necessity of refilling.

Closing the door


To close the door, fold the door upwards and press it until the motorized lock sets in. The door can be

unlocked and opened at any time before the program start using the key.

Selecting the program


You can switch between the programs using the key.
Choose the program according to the level of soiling of the →load.
The Universal-Program is sufficient for every-day general usage. The Quick-Program is designed for
lightly-soiled instruments.
The following table lists the correct program for each →load.

Program Nature of instrument/soiling Operating time*


(plus drying
time)
DTA DTB
Universal-Program For normal-heavily soiled instruments. This complies with the 36 Min. 53 Min.
90°C, 5 min. general hygiene-related requirements of DIN EN ISO 15883-
1.
Quick-Program For non- or slightly soiled instruments. 30 Min. 47 Min.
90°C, 5 min. As with the Universal-Program but without the pre-wash.
Not suitable for hollow bodied instruments (e.g. extraction
cannulas, hand pieces, turbines, cannulas)
Intensive-Program For particularly heavily soiled instruments 40 Min. 57 Min.
90°C, 5 min. like the Universal-Program, but with a longer cleaning time
Ophthalmo-Program For normally contaminated ophthalmology instruments, 42 Min. 59 Min.
90°C, 5 min. like the universal Universal-Program, but with a longer
cleaning time, double intermediate rinsing without rinse aid
**The operating times represent average values and apply only for the recommended running water pressure at a cold
water temperature of 15 °C.

26
Chapter 4 – Cleaning and Disinfection

Auxiliary programs Application Operating time


Rinse, 3 min, For soaking instruments with encrusted dirt, for rinsing 3 Min.
no disinfection strongly contaminated instruments, e.g. following soaking in
disinfection solutions (to avoid increased foam generation) for
washing out the chamber after salt refill;
without process agents, no disinfection.
Emptying Pumping out residual water in the washing chamber 1 Min.
Reference value For measuring the conductivity of the DI water 2 Min.
measurement DI
Air removal Bleeding the metering hoses upon commissioning, 5 Min.
maintenance, changing the process agents, product change
etc.
Regeneration Regenerating the internal water softening unit 8 Min.
Time metering Only for technicians
**The operating times represent average values and apply only for the recommended running water pressure at a cold
water temperature of 15 °C.

Starting the program

WARNING
The unauthorised operation of this device may cause damage to the device or the facility.
MELAG does not accept any liability for such damage.
 Never operate the device unattended. Unsupervised operation of electrical devices, including
this device at the operator’s risk.

After selecting a program using the key, in addition to the program selected, the display also indicates
the temperature and holding time.

P01 DOOR3 90°C 5min


Universal-Program

To start a program, press the key.

Program run
After starting the program, you can follow the program run in the →display. The program steps are
indicated on the display during the program run.

Pre-cleaning
Pre-cleaning is performed with softened water and without process agents. It is temperature controlled.
Coarse encrusted organic material is subject to mechanical dissolution. All proteins on the instruments
must be removed entirely. It is necessary to avoid → denaturation resulting from too a high water
temperature.

Cleaning
The actual cleaning is performed here. The washing chamber is heated until reaching the program-specific
temperature. This is then held during the holding time.
The cleaning agent is added automatically before the holding time begins.

Neutralization
If neutralization is necessary following cleaning, the neutralizer is added before circulation in order to
reduce the alkalinity and to free the instruments of acid-soluble deposits such as lime scale and
extraneous rust.

27
Chapter 4 – Cleaning and Disinfection

Intermediate rinsing
Intermediate rinsing is a preparatory step to disinfection to reduce the residual concentration of the
process agents.

Disinfection
Thermal disinfection with water takes place here.

Drying
The instruments are then dried by the integrated drying fan from inside and out. This prevents rust
accretion on the instruments. Instruments with a low inner diameter must be subsequently dried.

Follow the program run on the computer


You can follow the current progress of a current cleaning program in a web browser on every computer of
the user network via the website integrated in the device.
The device must be assigned an IP address and is connected to the user network.
1. Open a web browser window (we recommend Mozilla Firefox or Internet Explorer).
2. Enter the address of this device on the user PC in the address bar of the web browser, e.g.
192.168.57.41 and confirm with ENTER.
You can now view the program run or information regarding your device such as the serial
number or device software version.

Fig. 4: Example of a view in the web browser

Program ended
The display message indicates when and whether a program has ended successfully.

Universal-Program
successfully ended

To open the door after the program end, press the key.

28
Chapter 4 – Cleaning and Disinfection

This is how you control the cleaning outcome after the end of cleaning.
 Instruments must be completely clean and dry.
 Hollow body articles are still fixed. If they were not, they would need to be treated again.
 The interior of the hollow bodied instruments (lumen) are still freely accessible.
 The injector rail still sits snugly on the connection tube in the washing chamber.
 The nozzles and connections to the basis basket are still connected.
When all these provisions have been satisfied and the program has run without interruption, or
malfunction, the →load has been cleaned and disinfected.

NOTE
Open the door immediately after the end of the program to prevent the accretion of condensation.

NOTE
Hollow bodied instruments with a narrow internal diameter are to be dried subsequently with air.

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.

Universal-Program
Day: 4 Total: 106

Manual program termination

WARNING
Cancellation of a current program by deactivation at the mains switch may cause damage
at the device.
 Never abort a program by switching off at the mains.

Manual termination during drying

WARNING
If a program is aborted during drying, residual dampness will remain on the instruments.
The instruments should be dried manually.
 You abort a current program only in exceptional cases.

DANGER
The washing chamber and the instruments are still very hot in this program step. There is
a danger of scalding.
 Let the washing chamber cool out a little before removing the instruments. The door can be
opened as of a temperature of < 88°C

If a program is aborted during drying the program is classed as having been ended successfully.

29
Chapter 4 – Cleaning and Disinfection

Proceed as follows to abort the program during drying:


1. Wait until the display shows the following message.

Universal-Program
CANCEL DRYING 4

1. Press the key to abort the program. Confirm the abort with YES.

2. After a short time, you can open the door by pressing the + keys simultaneously. The
display contains information on how to do this.

Manual termination before beginning of drying

WARNING
If a program is interrupted before the start of a drying phase, the program is deemed not
cleaned and disinfected. There may be a danger of contamination.
The program will then need to be restarted.
 You abort a current program in exceptions.
 It is thus important to exercise extreme caution in dealing with instruments.
 The instruments can still be very hot if the door is opened after a program abort.

Press the keys to abort a current program before drying begins and follow the information on the
display.

Universal-Program
CANCEL 4

Removing the load

DANGER
The device may be damaged at improper opening of the door and/or steam may escape
from use of disinfectants.
 Never use force to open the door.

DANGER
Especially massive instruments can be very hot after the program end.
Therefore, there is the danger of scalding or burns.
 Allow the instruments, baskets and insert racks to cool before removing them.

30
Chapter 5 – Logging

Chapter 5 – Logging
In this chapter you learn
 Why and how you document batches
 Which output media you can employ for the batch documentation
 Where you can find the logs for the batch documentation
 How to read logs correctly

Batch documentation
The batch documentation acts as proof of the successful conclusion of the cleaning and disinfection
process and represents an obligatory part of quality assurance (→MPBetreibV).
The data, such as type of program as well as →batch and process parameters of the completed programs,
are stored in an internal log memory of the device.
For the batch documentation you can transfer the internal log memory readout and the data onto diverse
output media. This can be performed at the end of every program or at a later point, such as at the end of
the day.

Internal log memory


The capacity of the internal log memory is sufficient for approx. 30 logs. If the internal log memory
becomes full and at least one log has not been issued via an activated medium, the following warning will
appear on the display: Internal program log is full. Not all logs issued. The appearance of this warning
represents the last possibility to save the unissued log before the oldest logs are deleted and overwritten.
Select the required output medium in the setup menu and issue the relevant log.

Output media
You are able to issue and archive the logs of the completed programs on the following output media:
 MELAflash →CF card
 A computer in a user network (LAN).
®
 Log printer MELAprint 42 with network adapter
Any combination of the output media is possible. Thus it is possible both to save logs on the MELAflash
CF card and print them on the log printer.

As delivered, the MELAflash CF card is set as an output medium in the setup menu and thus the
automatic log issue at the end of a program (Immediate issue = YES) is thus activated. Log issue on
multiply activated media is performed successively.
If you wish to retain this state, following commissioning of the device, the relevant log will be issued on the
CF card and saved there as soon as a program ends (immediate issue = YES). To do this, the CF card
must be inserted in the slot of the device (see the next section Using the CF card as an output medium).

31
Chapter 5 – Logging

Using the CF card as an output medium

WARNING
When the CF card is pulled from the card slot prematurely or if it is treated improperly,
data loss, damage to the CF card, the device and/or its software may occur.
 Never push the CF card in the slot with force.
 Never remove the CF card from the slot whilst it is being written or read. The red →LED next
to the card slot on the right will illuminate red in short irregular intervals during reading and
writing access.

NOTE
The CF card cover cap must remain closed during operation.

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
main switch.
Proceed as follows in order to insert the CF card in the slot.
1. Open the →CF card cover cap (6) downwards

1. Mains switch
2. Card slot for the CF card
3. Ethernet-Data connection
4. LED
5. CF card ejection switch
6. CF card cover cap

Fig. 5: Card slot for the CF card

2. With the raised finger edge pointing leftwards, place the CF card in the card slot (2).
3. Push the CF card in the card slot until it clicks. When the CF card has been placed correctly, the
red →LED (4) to the right adjacent to the card slot will illuminate shortly.

32
Chapter 5 – Logging

Removing the CF card


Proceed as follows in order to remove the CF card from the slot.
1. Watch the →LED to the right of the card slot. The red LED illuminates red in irregular intervals
when a log is being saved on the CF card. If this is the case, wait until the →LED has
extinguished.
2. Press the ejection switch (5) underneath the card slot and remove the CF card.
3. Return the cover cap (6) to its starting position.

Computer as output medium

You can connect a computer to the device directly or over a network when the following prerequisites are
met.
 The computer has a network cared with a RJ45 socket (LAN).
 An FTP server or a FTP service is installed on the computer (when the log is issued via FTP).
 A suitable program, e.g. MELAview, is installed (when the log is issued via TCP).

Log printer as issue medium


®
If you want to use the log printer MELAprint 42 as an output medium, connect it to the device with the
®
network adapter (not in the scope of delivery of the MELAprint 42 – order no. 40295):
1. Plug (1) in the socket.
2. Connect the MELAG network adapter (3) with the supplied cable (2) to an Ethernet data
connection point of the back of the device (see page 9, Fig. 1).
®
3. Plug the MELAG network adapter (3) into the serial connection of the log printer MELAprint 42
(can be screwed).
4. Connect the cable (4) of the adapter (3) to the log printer electricity supply jack.
5. Switch on the device at the mains switch.
6. Now switch on the log printer.
7. Switch the device off and on again now.
In doing so, the device sends the IP address saved in the device as a parameter to the network
adapter and saves it.
1. Power supply
2. Connection cable

3. MELAG-Network adapter
4. Adapter cable

NOTE
If the above steps are unsuccessful, the IP addresses saved in the device and those of the
®
MELAprint 42 probably do not belong to the subnet, since the factory settings were changed.

33
Chapter 5 – Logging

Automatic immediate log output


Text logs
If you want to issue the relevant log automatically immediately after the end of a program, use the option
with immediate output = YES in the SETUP-MENU  02 Automatic Logging.

The following requirements must be fulfilled in order to issue text logs immediately after the end of a
program.
 In the setup menu  02 Automatic logging , immediate output is set to YES.
 In the setup menu  02 Automatic logging, at least one output medium is selected and 02
Automatic logging is thus set to ACTIVE.
®
 The activated output medium has been connected (e.g. log printer MELAprint 42) or the CF card
has been entered.

When automatic log output is not possible, e.g. because the activated output medium is not connected, the
text log is stored in the internal memory. It is not lost. A warning message appears.
The device registers as yet not issued logs for every output medium. It provides the option of issuing this
log at the next possible opportunity.
It is recommended using automatic logging with an immediate log output.
If you want to issue the associated text logs automatically after the end of a program on the output medium
set on 02 Automatic Logging, must be set to YES.
As delivered, the device is set to automatic log output of the text logs via the CF card, immediately after
the program has ended.

Graphics Logs (optional)

The following additional requirements must be fulfilled in order to record graphic logs:
 In the SETUP-MENU  02 Automatic logging  Graphics logs, at least one output medium is set
to YES.
 At least one of the output media selected corresponds to an output medium for the text log.
 The activated output medium is connected, e.g. computer, or the CF card has been plugged in.

Explanation of the possible settings for graphic log recording:

Graphics & CFC


In the menu Graphic Log  Graphic+CFC or Graphic+Comp, select the output media on which the
graphic log is to be saved.
At least on of the two output media must correspond with the medium selected for the output of text logs.

01 Graphic Logs
Graphic+CFC YES

CFC-Interval
CFC interval or PC interval indicates the time intervals in which the program curve is recorded on
the CF card or computer. The smaller the time interval, the more exact the curve. In the example, the time
interval is set at 1 second.
03 Graphic logs
CFC interval 00001

34
Chapter 5 – Logging

PC-backup
PC backup indicates the time interval in which the graphic logs are to be saved on the computer by the
device. In the example, the backup interval is set to 30 seconds.

05 Graphic logs
PC-backup 00030

NOTE
Graphic logs cannot be saved in the internal log memory. If you wish to record optional graphic
logs in addition to the text logs, please always ensure that at least one common output medium
has been set for issuing text and graphic logs. This means that at least the computer or the CF
card should correspond as output medium for both log types.

Output the logs subsequently


The docu menu provides the option of issuing logs subsequently and independently of the point of the
program end. You can use the output media activated for the log automatic in the SETUP MENU  02
Automatic logging or any other output medium.

1. Push or to navigate in the main menu to DOCU-MENU.

2. Push to open the Docu menu.

3. Push repeatedly to select the desired output medium. If you want to assume the settings
from the menu Automatic logging, select the option automatic.

4. Push to get to the option log type.

5. Push to choose between the log types, e.g. last log, log of the day, etc.

6. Push the in order to start the log output.

Delete saved logs


In order e.g. to suppress the warning text Protocol memory full for preset option Immediate
output NO, the saved logs can be manually deleted as follows:

1. Push or to navigate in the main menu to DOCU MENU.

2. Push to open the Docu menu.

3. Push to get to the option log type.

4. Push to navigate to 06 All logs .

5. In order to delete all logs, confirm the query by holding they keys + .

Determining the format for the program log


A log is saved in the internal log memory for every program run. The log format enables you to determine
which of the data saved should be issued. You can choose between the format (0001) and the more
comprehensive format (0002).
The log format (0002) is the standard format. The log format is saved in the program log in the setup menu
(see page Chapter 5 – Logging).

35
Chapter 5 – Logging

Log format

Content 0000 0001 0002*


0000 Header X X X
Program step values X X
0001
Key X
0002 * Standard format

Header
The header comprises lines 15 to 83 and contains
the most important information on the elapsed
program (see Fig. 6). Information on the device, such
as serial number, current software version of the
firmware, parameter and operating interface is
issued as well.

Program steps
During the program, the program steps are recorded
together with the associated values for temperature,
time, consumption of process agents, the cleaning
pressure, the volume of cold water and DI water, the
→conductivity as well as the start and end times.
Upon the incidence of a malfunction, row 92 issues
warnings and error messages.
The end of the log displays the proof of validity and
program-specific values in code.

Key
The key is a component of the log format 0002. It
serves to mark the program steps to which the
values given relate.
In digitally outputted logs (→CF card, PC) the key is
located directly next to the values of the respective
program step.
®
In logs issued via the log printer MELAprint 42, the
row containing the key is always located under the
row to which it refers.

36
Chapter 5 – Logging

Log types
In addition to logs for successfully completed programs, there are many other types of log. These can be
issued via the list in the Docu 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 The log in which the process is 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 faults and changes to the system in order of time (log
book)
STA Status log Summary of all the important settings and system states (counter,
measurement values etc.) + a list of all procedure-relevant parameters
(VRP)
LEG Caption log Contains all step abbreviations used in the program log
DEM Demo log Log of a successfully completed simulated program in DEMO mode
(only for presentation purposes)
DES Demo malfunction Log of a program simulated as interrupted (presentation)

37
Chapter 5 – Logging

----------------------------------------
10 MELAG MELAtherm 10-DTA 10 Name of the device
----------------------------------------
15 Program : Universal-Program 15 Program name
20 TARGET °C min 20
21 Pre-clean: 22.0 01:30 21
23 Cleaning : 55.0 07:00 23 TARGET Value: Temperature and holding time of the partial cycles
28 Disinfect: 90.0 05:00 28
30 Date : 10.06.2013 30 Date
35 Batch : Day:01 Total:03240
35 Day and total charge number
=====
40 Program successfully ended 40 Control message
42= 42 Program abort, if program unsuccessful
======
50 ACTUAL °C +/- K min 50
51 Pre-clean: 27.0 +0.1/-0.1 01:30 51 ACTUAL-value: Temperature (range) in C°, holding time of the partial
53 Cleaning : 57.6 +1.4/-0.6 07:00 53 cycles.
58 Disinfect: 92.1 +0.1/-0.1 05:00 4007 58 ACTUAL value Temperature conditions of the disinfection, A0 value
------
60 Conduct. : 13.6 (---) µS/cm 60 →Conductivity of the DI water for the final rinse

65 Start : 12:56:58 65 Time at the start of the program

70 End time : 13:56:45 (59:47 min) 70 Time at the end of the program (Program length)
======
80 SN:201010-DTA1006 80 Device serial number
======
81 Firmware : V1.309 01.03.2013
82 Parameter: V1.309 25.01.2013 81 installed firmware version
83 BO : V1.305 25.01.2013 82 installed parameter version
---------------------------------------- 83 installed operating interface
Step Start End Time °C ml mbar Program step values and key
--> Process start
S1X01 0:00 0:00 0:00 24.8 ---- ---
Time Time (mm:ss), since the program start
--> Pre-cleaning
V1E01 0:00 0:03 0:03 24.8 ---- --- min: Duration (mm:ss), of a program step
V1P01 0:03 0:07 0:04 24.8 ---- ---
V1S12 0:07 0:13 0:06 24.8 555 --- C° Temperature of the →rinse liquor in the washing chamber in Celsius
V1P06 0:13 0:23 0:10 24.8 ---- ---
. ml Volume of CW/DI water, the process agent consumed during a
. process step.
--> Cleaning
R1E02 4:13 4:16 0:03 27.1 ---- --- mbar Rinse pressure
R1P01 4:16 4:20 0:04 27.1 ---- ---
R1S02 4:20 5:06 0:46 23.4 5555 ---
R1H02 4:20 6:21 2:01 39.8 ---- ---
R1U03 4:20 6:21 2:01 39.8 ---- 295
.
.
--> Neutralizing
N1E01 15:36 15:40 0:04 56.5 ---- ---
N1P01 15:40 15:44 0:04 56.4 ---- ---
N1S03 15:44 16:27 0:43 32.3 5055 ---
.
.
--> Intermediate rinsing
Z1E02 17:54 17:55 0:01 34.0 ---- ---
Z1P01 17:55 17:59 0:04 34.1 ---- ---
Z1S04 17:59 18:41 0:42 23.0 5060 ---
.
.
--> Disinfecting
D1E02 20:01 20:01 0:00 24.4 ---- ---
D1P01 20:01 20:05 0:04 24.4 ---- ---
D1S05 20:05 20:51 0:46 27.0 5055 ---
D1H08 20:05 20:52 0:47 27.1 ---- ---
D1U03 20:05 20:52 0:47 27.1 ---- ---
.
.
--> Drying
T1E01 34:02 34:05 0:03 91.1 ---- ---
T1K07 34:02 34:22 0:20 91.0 131 ---
T1E01 34:22 34:32 0:10 90.8 ---- ---
T1K07 34:22 34:48 0:26 90.2 131 ---
T1E01 34:48 35:00 0:12 90.0 ---- ---
T1T04 34:48 37:57 3:09 82.3 ---- ---
.
--> Process end
E1Z01 59:39 59:47 0:08 40.0 ---- ---

92-------------------------------WARNING 92 Up to a possible 5 warnings


>Event Step Time Hint 95 Fault numbers upon program interruption
---------------------------------------- Proof of authenticity
>> Never change code in following row << May never be altered; indicates that the data was generated on a
530000ED001D000D67EF0E0A030004AD00000000 MELAG device and has not been changed.
>> Proof of authenticity batch log <<
----------------------------------------
Voltage max/min: 238/227 Sensor measurement values are displayed in the case of a
CW:25.4 DI: 5.0
malfunction. The values are helpful for a technician.
0.0 0.0 -0.00 0.0 -0.00
--et1---et2----eps----etu----epx---END--
Fig. 6: Example of a program log for a successful finished Universal-Program

38
Chapter 5 – Logging

Finding Logs
All memory media (→CF card or computer) contain a directory with the encoded serial number of the
device concerned following log output. The folder name consists of five characters identical with the first
five characters of every log, e.g. CR0ZH.
The directory contains sub-directories containing the month of the log generation e.g. 01_2013 for January
2013. These contain all the logs generated by device in this month. The device directory is entered in the
main directory on the CF card.

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 creates one of a
device and a month.
If logs are issued on the same memory medium more than once, a “duplicated" directory will be created
under the device directory in which these logs will be saved only once.

NOTE
If possible, do not rename the directory otherwise logs will be stored in both the renamed
directory as well as the device directory generated automatically by the device.

Direct transfer of the log to a computer via the network and using the MELAG FTP server allows you to
determine directly in the FTP server where on your computer the device directory with log files is to be
saved.
When issuing via TCP and e.g. MELAview, you also determine the filing folder right in the program.

39
Chapter 6 – Settings

Chapter 6 – Settings

Opening the setup menu


1. Push to navigate in the main menu to M02 SETUP MENU.

M02
SETUP MENU

1. Push to open the setup menu.

2. Push to leave the setup menu.

3. Push the in order to save the change or

4. Hold in order to discard the change.

DISCARD 3h
SAVE 4

Water supply
®
If a DI connection is available for the device, e.g. the MELAdem 53 or another water treatment unit is
connected, this must be set on the device.
In its delivery state, the water supply has been set to DI water YES.
To alter this setting, proceed as follows:
1. Open the setup menu as described above.
This display registers the option 01 DI water YES.

01 SETUP MENU
DI water YES

2. Push in order to change the option. The value YES flashes.

3. Push or to switch between YES and NO.

4. Push to save the new value. The value no longer flashes.

5. Push to leave the setup menu (see above).

40
Chapter 6 – Settings

Automatic logging
Menu 02 Automatic logging is used to undertake all settings concerning the issue of logs and which
are to be made only once. Examples include the choice of output media, activating the immediate output,
log format etc. All future program logs will always be issued from the respective output media using the
settings made here.
The display image shows whether the option for log output is ACTIVE or not.

02 SETUP-MENU
Autom. logging ACTIVE

Detailed information on logging is found in Chapter 5 – Logging.

Determining the output medium


In menu 02 Automatic Logging, the selectable output media are displayed one by one, e.g. CF card,
computer, MELAprint, etc.

1. Push repeatedly to navigate in the setup menu to 01 CF-Card YES.

01 Automatic logging
CF card YES

2.
The display of YES indicates that the log is to be saved on the CF card. If a log is not to be saved
on the CF card the setting must be changed to NO.

3. Push to change the value. The value YES flashes.

4. Push or to switch between YES and NO.

5. Push to save the new value. The value no longer flashes.

6. Push to leave the setup menu (see above).


7. Proceed in a similar manner to set a different output medium.

Determining log format


Detailed information on the log formats 0001 and 0002 can be found in Chapter 5 – Logging.

Date and time


Date and time of the device must be correctly set for proper batch documentation. Observe the time re-
settings in autumn and spring ("daylight saving time"), since this is not reset automatically

Setting the date


Set the date and time as follows:

1. Push repeatedly to navigate in the setup menu to 03 Date.

03 SETUP MENU
Date 12.01.2010

41
Chapter 6 – Settings

2. Push to change the date. The display changes to 03 Change date.

03 Change date
Day 12

3. Push repeatedly to choose between day, month and year.

4. Push to alter the parameters selected, e.g. the day. The current value flashes.

5. Push or to reduce or increase the value.

6. Push to save the new value. The value no longer flashes.

7. Push to change the month next. Proceed accordingly.

8. Push to leave the setup menu.

Setting the time


To set the time, proceed as described in the previous section Setting the date.

04 SETUP MENU
Time 13:45

Display contrast
1. Push repeatedly to navigate in the setup menu to 05 Display contrast.

05 SETUP MENU
Display contrast

2. Push to change the contrast.

3. Push or to reduce or increase the contrast.

4. Push to save the settings.

5. Push to leave the setup menu.

42
Chapter 6 – Settings

Language
The device offers a selection of two languages. You can select the language in the setup menu.
Language 1 is usually the local language, Language 2 is English.

1. Push repeatedly to navigate in the setup menu to 06 Language.

06 SETUP MENU
Language 0001

2. Push in order to change the language. The current value flashes.

3. Push to change to language 002.

4. Push to save the settings.

5. Push to leave the setup menu.

If you wish to set a language other than those installed on the device, you must perform
a language update from the CF card with the appropriate language file.
Please consult your MELAG customer services/stockist.

Water hardness
1. Push repeatedly to navigate in the setup menu to 07 Water °dH.

07 SETUP Menu
Water °dH 20.0

2. Push to change the value. The value flashes.

3. Push or to reduce or increase the value.

4. Push to save the new value. The value no longer flashes.

5. Push to leave the setup menu (see above).

You can find a water hardness conversion table on page 14.

43
Chapter 7 – Function Test

Chapter 7 – Function Test


In this chapter you learn
 How the device automatically carries out the function test
 Which possibilities you have for the manual function test
 Which function tests are to be conducted in daily operation
 How to display the water quality

Automatic function test


The monitoring system of the device checks the device components with regard to their functional
reliability and their plausible interaction. If the parameters exceed defined limit values, the device outputs
warning messages or error messages. If necessary, it interrupts the program with a corresponding notice.
If the program was successfully concluded, an appropriate message is issued on the →display.

Manual function test


You can follow the program run on the →display via the values displayed there. You can also use the logs
recorded for every program to determine the success of a program (see page Chapter 5 – Logging).

Testing in daily operation

Check the following items every day before work starts:


 Coarse and fine filter is inserted
 Rinse arms are free
 The interior of the washing chamber and the door seal are undamaged
 Baskets and inserts are inserted correctly

Follow the instructions in Chapter 8 – Maintenance as well.

Measuring conductivity
You can access the water quality of the DI water on the device on the display at any time providing, that it

is switched on. To do so, start the supplementary program “Conductivity DI" with the key.

Z03 DOOR 3 MEASURE 4


Conductivity DI

44
Chapter 8 – Maintenance

Chapter 8 – Maintenance
In this chapter you learn
 How to clean the device
 Which cleaning agents are suitable for this purpose
 How to avoid the formation of spots
 What to observe in device maintenance

Daily inspection/cleaning
Inspection of the filters in the washing chamber
The coarse and fine filter in the base of the washing chamber serves to hold back dirt particles or residue
which has been cleaned from the instruments. As a result, the filters can become blocked over time.
Check the coarse and fine filter on a daily basis and where necessary, clean it under running water:
1. Turn the coarse filter all the way to the left by the handle and remove upwards.
2. Loosen the fine filter by turning the knurled nut, take it out and flush the two filters under running
water if required. Remove deposits with a soft brush if required. Do not use any detergent.

WARNING
When the coarse and fine filter is not inserted, residue may enter the flushing circuit and
impair the device function.
 Ensure that the coarse and fine filters are always in place before program start.

Checking the rinse arms


Fine dirt particles can block the nozzles of the rinse arms.
Therefore, the rinse arms have been taken out and the nozzles may be flushed under running water.
1. Loosen the curled nut by turning and remove the upper and lower rinse arms upwards and
downwards respectively.
2. Clean very blocked nozzles with a thin pointed object.

3. Return the rinse arms and ensure their free movement.

45
Chapter 8 – Maintenance

Checking the door seal


Check the door seal for impurities, deposits or damage on a daily basis.
Clean any impurities with a damp, non-fuzzing cloth and a commercially available neutral liquid cleaning
agent.

Inspection of passage of the nozzles of the injector rail


To test whether the nozzles on the injector rails are blocked, they must be held upright under running
water.
If the water flows through freely, then the nozzles are not blocked.

Cleaning on demand
Outer front of the device
The operating unit and the plastic front of the device should only be cleaned using a damp cloth or a
suitable plastic cleaning agent. Check the material compatibility before application! Never use cleaning
agents or benzene.
When using area disinfectants, observe that they are suitable for plastic. Observe the manufacturer's
information on the respective disinfectant.

Pump pit and non-return valve


Any fine particles having passed through the coarse and fine filter into the water cycle should be removed.
This is observable if the flushing water cannot be pumped away after a program has finished.
1
1. To do so, check the pump pit by removing the coarse and fine filter beforehand. Remove any
residue/deposits.
2. Pull the non-return valve upwards and remove it from the pump pit. If necessary, clean it under
running water.

3. If necessary, start the rinse program to wash away any particles thus removed.

NOTE
Should this occur repeatedly, inform your stockist or MELAG customer services upon the next
maintenance interval.

1
The pump pit is the plastic container below the coarse and fine filter by which the water is recirculated.

46
Chapter 8 – Maintenance

Changing the HEPA 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.
1. Pull the drawer outwards.

2. Loosen the bayonet cap on the cover cap by turning it and lift up the cover cap.

3. Pull out the pre-filter upwards and replace it.


4. Take out the HEPA filter upwards and replace it.

5. Replace the cover cap and fasten the bayonet cap.

DANGER
Careless touching of the HEPA filter may damage the lamellae.
This may impair filter services and recontamination of the disinfected instruments.
 Only touch the HEPA filter by the frame and do not damage the lamellae.

NOTE
The pre-filter and HEPA filter must be changed yearly (e.g. during maintenance).

47
Chapter 8 – Maintenance

Avoid formation of spots


Stains on the instruments or the device can develop from poor water quality.
To avoid the development of stains on the instruments or the washing chamber, we recommend a final
rinse with →deionised water (DI water).
All water-conducting parts of the device are made of non-rusting materials. This excludes the formation of
stains or rust caused by the device.
Should rust stains occur, then we are dealing with third-party rust. Often a rust-producing instrument
already suffices for third-party rust to form on the other instruments or in the washer-disinfector. Poor water
quality containing heavy metal or chloride can result in the development of stains or rust.

Maintenance

WARNING
Malfunctions at the device can occur on continuation of operation despite the servicing
message.
 Maintenance should only be performed by trained customer services technicians, or
specialist dealer technicians. Consult your specialist dealer or the nearest MELAG customer
services point.
 Maintain the specified servicing intervals.

Regular maintenance is indispensable for the retention of value and the reliable practice operation of the
device.
All function and safety-relevant components and electrical units are checked during maintenance and
replaced where necessary. Maintenance is carried out according to the maintenance instructions relevant
for this device.
Arrange for maintenance after every 1000 cycles or once a year. At this point in time, the device issues an
appropriate maintenance reminder message.

(Process) validation
The practice operator is responsible for ensuring excellent operation and a reproducible outcome in the
cleaning and disinfection process.
In Germany, this requirement is anchored in the Medical Devices Operating Directive (§ 4 para. 2
MPBetreibV), the guidelines from the DGKH, DGSV and AKI and the recommendations’ of the Robert
Koch Institute.
This requirement is also made in international regulations. The basis of the requirement is DIN EN ISO
15883, also valid in Germany.
Please observe all valid national regulations and specifications. In case of doubt, please consult the
relevant professional association.
A reproducible cleaning and disinfection outcome can be guaranteed through the use of batch, routine
and/or periodical checks (e.g. a validation).

48
Chapter 9 – Operating Pauses

Chapter 9 – Operating Pauses


In this chapter you learn
 How quickly you can begin consecutive programs
 What you must observe with longer operating pauses
 How to decommission, transport and then recommission the device

Pause times
Pause times between individual programs are not necessary. Instruments can be re-arranged and then
cleaned and disinfected after a program run or interruption.
For operating pauses of a duration of more than two weeks, please ensure that the metering hoses are de-
aerated using drinking water (see Bleeding the metering hoses, p. 20) so as to avoid the deposition of
crystals.
Bleed the metering hoses repeatedly before re-commissioning using process agents and perform the tests
described in Chapter 7 – Function Test.

Shut-down

DANGER
Improper handling of the process agents may cause health damage, e.g. caustic burns.
 Ensure that you observe the information of the respective process agent manufacturer.

If you would like to shut down the device, e.g. during holidays, proceed as follows. The washing chamber
should be dry on the inside:
1. Remove the suction lances from the container and place them in a receptacle of water. The
suction lances should be at least 80% immersed.
2. Run the “air-removal“ program to free the metering system from process agents.
3. Return the suction lances to the process agents and screw them on tightly.
4. The interior of the washing chamber must be dry.
5. Switch off the device at the mains switch.
6. Pull the power plug from the wall socket.
7. Turn off the water feed.

WARNING
Run the „air-removal“ program two times before you start a treatment program .

Transport
Decommissioning in preparation for transport may only be undertaken by MELAG-authorised individuals.

DANGER OF INJURY
Incorrect carrying can result in injury to the spine or pinching.
 Two people are necessary to carry the device.

49
Chapter 9 – Operating Pauses

When transporting the device e.g. during a move, despatch or within the practice, observe the following:
 Empty the device entirely
 Tightly close the water supply hoses.
 Remove the basis basket and inserts.
 Close the door before moving the device.

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

Re-commissioning after change of locality


To recommission the device following relocation, proceed as described in the first commissioning (see
Chapter 3 – Initial Commissioning).

50
Chapter 10 – Errors

Chapter 10 – Errors
In this chapter you learn
 The different types of messages
 How to react to errors
 What you can do before calling the hotline

Messages
A message is not a malfunction. It serves to inform and provides assistance in the operation of the device.

Warning messages
A warning is not a malfunction. It helps to ensure smooth operation and to recognize undesirable
conditions. Observe these warning messages promptly in order to avoid errors.

Error messages
Error 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 while a program is running.
If a malfunction occurs during a program run, the program will be discontinued.

DANGER
If a program is interrupted before the start of a drying phase, the →load is taken as not having
been cleaned and disinfected. Complete cleaning and disinfection is a precondition for use and/or
sterilization.
Incompletely cleaned and disinfected instruments endanger the health of your patients
and the practice team.
 The load must be cleaned and disinfected again at premature cancellation of the program.

Before you call


Warnings are marked by a W and error messages with a F. Follow the operating procedures shown in
connection with a warning text or an error message on the →display of the device. You will find the most
important events in the following table. Possible causes and appropriate operating instructions are listed
for the events.
If you do not find the event in the table below or your efforts do not lead to success, turn to your specialist
dealer or the →authorised MELAG customer service centre in your vicinity. System errors can only be
rectified by an authorised customer services technician. In order for us to help you, keep the serial number
of your device and a detailed error description of the error message ready.

51
Chapter 10 – Errors

Incident Possible cause What you can do

Banging or rattling noise Rinse arm is banging against the Interrupt program, re-pack load and re-
in the washing chamber load start program

White layer on the The water softening unit has not Check tap water hardness. It could be
instruments been programed correctly. necessary to re-program the unit, see
Chapter 2 – Device Description.
Dental cement residue on the Clean the instruments by hand after the
instruments cement has hardened
Stain development on Concentration of the rinse aid set too Increase the concentration of the rinse
the instruments low aid
Poor cleaning outcome Basis basket/insert baskets/ Sort the load correctly and do not
racks loaded incorrectly or too full overload
Load results in a spray shadow Avoid a spray shadow
Cleaners are unsuitable for this kind Use a suitable cleaning agent for
of contamination automatic cleaning
Encrusting too strong Do not allow dirt to dry for longer than 6
hours
Rinse arm nozzles or injector rail Remove blockages, see Chapter 8 –
nozzles blocked Maintenance
Pump pit filter soiled Clean coarse and fine filter, see
Chapter 8 – Maintenance
Device does not start, Device is not switched on Switch on device at mains switch
display empty
Device is not plugged in Plug in at mains
Fuse has tripped Activate fuse (see name plate for
minimum fusing)
Display message: Salt container is empty. Fill regenerating salt into the salt
Salt storage empty Regeneration salt has been container
Please refill! exhausted The signal (a tone) informs the operator
Then wait for signal that the salt in the salt container has
been recognized and that operation can
be continued.
Residual dampness on Basis basket/insert baskets/ Sort the load correctly and do not
the instruments racks loaded incorrectly or too full overload, dry instruments afterwards
Residual dampness in Dry those instruments with a low inner
hollow-bodied diameter with medical compressed air
instruments

52
Chapter 10 – Errors

Warning and error messages


No. Display text Possible cause What you can do

W 397 No connection to the The FTP server program Start the FTP server program
computer has not started
An Ethernet cable is not Connect an Ethernet cable
connected
With a TCP connection: Open program MELAview,
MELAview not started check settings in MELAview.
Incorrect settings in
MELAview
The settings on the Check the network settings on the
device or computer are device and computer
incorrect
F 410 Rinse aid exhausted Process agent Refill with process agent then clear
F 411 Neutraliser exhausted exhausted, program
F 412 Cleaner exhausted does not start with the key and re-start the
program.
W 414 Rinse agent just The process agent has Refill process agent, see Chapter 3 –
exhausted. been consumed Initial Commissioning, section
W 424 Neutralizer just exhausted Process agents

W 425 Cleaner just exhausted


F 426 Air-bubble formation R/ Metering hose kinked, Start Air removal program
Start Air removal tumble hose in the (to avoid malfunction, store the suction
F 427 Air-bubble formation N/ metering pump torn. lances of process agents not used, e.g.
Start Air removal rinse aid, head first in the suction lance
bracket).
If this does not have any effect, inform
supplier/MELAG customer services.
W 428 Please refill salt soon There is almost no Approx. 10 washing runs are possible,
regeneration salt left the salt must be refilled soon
F 431 Min. feed rate R not Minimal feed rate of Start Air removal program.
reached/start Air removal. cleaning agent/ (To avoid malfunction, store the
Min. feed rate N not neutralizer not reached suction lances of process agents not
F 432 reached/start Air removal. used, e.g. rinse aid, head first in the
suction lance bracket).
If this does not have any effect, inform
supplier/MELAG customer services.
F 433 Please see user manual Fine filter in pump pit Remove the fine filter and clean
choked
Non-return valve in the Check whether the non-return valve
pump pit is missing or has been fitted in the pump pit
fitted incorrectly, correctly, check non-return valve in
Foreign objects in the pump pit for soiling
outlet pump
F 434 Please see user manual Outlet hose kinked, Check the effluent hose for kinks or
outlet or outlet hose pinching
blocked
Foreign objects in the Check non-return valve in pump pit for
outlet pump soiling
F 451 Please see user manual Spray shadow from Check the load and restart the program
improper loading. if necessary
Insufficient water comes Upon repeated occurrence, inform your
into contact with the stockist/MELAG customer services
temperature sensor

53
Chapter 10 – Errors

No. Display text Possible cause What you can do

F 464 Check cold water intake Water tap closed, Open water tap, check filter in
Filter blocked in aquastop of intake hose
aquastop of intake hose Check installation of intake hose
Intake hose kinked
during installation
F 465 Please see user manual The option DI water Set the option DI water to NO or check
"YES" has been set in the water treatment unit
the setup menu, but a
water treatment unit is
not connected
F 466 Check DI water intake see F464
F 467 Check cold water intake see F464
F 474 HEPA filter missing or flap HEPA filter or drying fan Check whether HEPA filter has been
open or system flap not inserted or inserted and whether flap has been
closed closed properly
The flap on the drying Check whether the drying fan flap has
fan has not been closed been closed
properly
F 476 Please see user manual Drying pressure too low Check pre-filter and HEPA filter in the
drying fan for clogging
If this does not have any effect, inform
supplier/MELAG customer services.
F 484 Please see user manual The basis basket is Check whether the basis basket has
missing or fitted been fitted correctly
incorrectly
Strong foam generation: Soak instruments in water only or rinse
Instruments were pre- thoroughly
treated (possibly heavily Receptacles with large openings are to
foaming solution) and be placed in the device with their
rinsed insufficiently openings facing downwards
Incorrect rinse aid or Check whether the process agents
cleaner used have been approved by MELAG
Dosage concentration Check dosage concentration
set incorrectly
W 501 CF card not recognized CF card was not inserted Insert the CF card in the device front.
at program begin or log
issue.
W 502 Computer connection not see W 397
recognized
F 505 Salt store empty Salt container empty Refill regenerating salt
Wait for about 3 min. before starting a
new program so that the salt can
dissolve after refilling.
F 509 Emergency overflow Leaks in the device (e.g. Stop water supply!
Stop water supply water, rinse liquor, Inform your stockist/MELAG customer
process agents) services!
If there is any liquid in the device, e.g.
in the bottom trough, this may also be
process agent in case of damage.
Ensure that you observe the
information of the respective process
agent manufacturer.
F 512 Power outage A running program was
Attention! Load interrupted by a power Clear with key. Program must be
NOT disinfected! outage re-started. Disinfection not guaranteed.
Do not switch off the device whilst a
program is running.

54
Chapter 10 – Errors

No. Display text Possible cause What you can do

F 531 Emergency unlocking Emergency unlocking Clear the message, close the door and
activated during a re-start the program
current program
W 533 CAUTION! Temp. high/ The temperature of the WARNING! A high chamber
Open door? washing chamber is a temperature following program end/
minimum of 55°C when abort.
program is finished or is Wait until the washing chamber has
interrupted. cooled. CAUTION! Instruments are
hot.
W 534 Temp. too high Program was interrupted The door remains locked for your
Please wait e.g. by operator, safety until the chamber temperature
message is issued at a has fallen. Then open the door using
min. temperature of
88°C the key. CAUTION! Instruments
are hot.
F 535 Fine filter not recognized Fine filter in pump pit Fit the fine filter, start the program
missing
F 536 Blockage upper rinse arm, Rinse arms blocked by Re-sort load, remove blockage, clean
please clean rinse arm load rinse arms
F 537 Blockage lower rinse arm, Nozzles blocked
please clean rinse arm
F 538 Min. speed Basis basket absent or Check seat of the basis basket (see
upper rinse arm. inserted in the wrong page 25)
Please clean. position, Clean rinse arms, see Chapter 8 –
Nozzles of the rinse Maintenance
F 539 Min. speed
arms clogged
lower rinse arm.
Please clean.
®
F 548 DI water quality insufficient The DI water MELAdem 53
conductivity is too high Mixed-bed resin must be replaced.
(≥ 60 S/cm); mixed-bed Insert a new resin cartridge.
resin in the water Other water treatment systems;
treatment unit is Change the module/resin cartridge in
exhausted accordance with the manufacturer's
operating instructions.
®
W 549 Poor DI water quality The DI water MELAdem 53
conductivity is too high Mixed-bed resin must be replaced.
(≥ 15 S/cm); mixed-bed Insert a new resin cartridge.
resin in the water Other water treatment systems;
treatment unit is Change the module/resin cartridge in
exhausted accordance with the manufacturer's
operating instructions.

F 571 Brine in chamber/ Brine is in the washing Start the “Regeneration" program
start regeneration chamber or water
softening unit. Program
cannot be started.
W 572 Power outage during Device was switched off Switch on device at mains switch and
regeneration at mains switch during re-start the “Regeneration“ program
regeneration
F 583 Please see user manual Cold water intake Check whether the water intake shut-
hindered off valve is open
F 620 Foaming during circulating Metering concentration Restart program.
of the cleaning agent Upon repeated occurrence, inform your
may be incorrect stockist/MELAG customer services
W 622 Maintenance required 1000 programs have Contact a MELAG customer services
been run/a year has provider or your stockist to arrange
elapsed since the last servicing. The device can still be
servicing. started.

55
Chapter 10 – Errors

No. Display text Possible cause What you can do


®
W 671 Poor conductivity/ The DI water MELAdem 53
Final rinse conductivity is too high Mixed-bed resin must be replaced.
(≥ 15 µS and < 25 µS); Insert a new resin cartridge.
mixed-bed resin in the Other water treatment unit:
water treatment unit is Change the module/resin cartridge in
exhausted accordance with the manufacturer's
operating instructions.
®
F 672 Insufficient conductivity/ Conductivity too high MELAdem 53
final rinse during final rinse (= 25 Mixed-bed resin must be replaced.
µS), Insert a new resin cartridge.
Mixed-bed resin in the Other water treatment unit:
water treatment unit is Change the module/resin cartridge in
exhausted, transfer of accordance with the manufacturer's
process agents operating instructions.
If this does not have any effect, inform
supplier/MELAG customer services

56
Appendix A - Accessories

Appendix A - Accessories

Article Order no.

Optionally available Floor unit (HxWxD 40 cm x 59.8 cm x 59.8 cm) 11020


Stainless steel cover plate (HxWxD 1.8 cm x 59.8 cm x 59.8 65310
cm)
Process agents 5 l canister for process agents 64010
1 l container for rinse aid 60910
®
Water treatment MELAdem 53 01038

For documentation: MELAflash CF card 01043


MELAflash Card reader 01048
®
Log printer MELAprint 42 01042
®
MELAG Network adapter for MELAprint 42 40295

Other Pre-filter 68130


HEPA filter 51240
Feed funnel 68200
Transfer spigot for rinse aid 70100

*All articles listed are available via your specialist dealers.

57
Technical Data

Technical Data
® ®
Model name MELAtherm 10 DTA MELAtherm 10 DTB
1) 2)
Electrical connection 3N AC 380-415V , 50Hz, 3x16A AC 220-240 V , 50Hz, 1x16A,
9.3 kW 3.3kW

Under-desk unit Free standing Top-frame device


Device dimensions (HxWxD) 81.8 x 59.8 x 83.6 x 59.8 x 67.8 cm 124 x 59.8 x 67.8 cm
67.8 cm

Washing chamber (HxWxD) 29 x 45.5 x 42.3 29 x 45.5 x 42.3 cm 29 x 45.5 x 42.3 cm


H= max. loading height cm

T= max. loading depth

Volume of the washing chamber 84 Litres

Weight (empty) 79 kg 85 kg 106 kg

Floor loading c. 2,800 N/m² c. 2,800 N/m² c. 4100 N/m²

max. load of the door 15 kg

Max. audibility (cleaning)  62 dBA

Waste heat 0.75 kWh (2.7 MJ)

Surrounding temperature 15 - 35°C

Relative humidity 30 - 60%

Max. set-up height 1500 m (it may be necessary to reduce the disinfection temperature
depending on the installation height. Consult technical manual)

Installation category 2

Air pressure 75 kPa – 106 kPa

Connection CW/DI water 3/4“

Effluent connection DN21

Water quality Drinking water according to 
Drinking Water Ordinance (TrinkW2001)/


observe local specifications

Minimum flow pressure 150 kPa (1.5 bar)

Recommended flow pressure 250 kPa (2.5 bar)

Maximum water pressure 1000 kPa (10 bar)

Minimum rinsing pressure 140 mbar

Max effluent temperature 93 °C (< 1 min.)

Amount of effluent per hour ca. 30 l (in small intervals)

Evacuation drain pump max. 40 l/min. (Volume in effluent hose)

Length of the intake hose and 1.80 m each


outlet hose

Length of power cable 2m

Degree of soiling Category 2

Degree of protection (following IP20


IEC 60529)

CE mark CE 0535
1) Observe the maximum voltage range of 360-440 V
2) Observe the maximum voltage range of 207-253 V

58
Glossary

Glossary
A0-value HEPA filter
The A0-value of a disinfectant procedure is the value, (High Efficiency Particulate Air filter) refers to a particular
indicated in time equivalent in seconds, at a temperature class of filter. Used in medical environments to purify the
of 80 C° transferred to the product referring to micro- air microbiologically from suspended particles.
organisms with a z-value of 10.
LED
A0 =  10(T-80)/z t (A0 is the value where z is 10°C; t is
Abbreviation for Light Emitting Diode: illuminates upon
the selected interval in seconds;
current flow. LEDs are predominantly used in device
T is the temperature in the load in °C)
status displays.
AKI
Load
Arbeitskreis Instrumentenaufbereitung
Designates all possible instruments, e.g. dishes, glass
Authorised persons goods and other objects that can be prepared in this
Medical specialist dealers, technician from depots or with device
customer service designated by MELAG, who were
MPBetreibV
trained by MELAG
Ordinance covering the installation, operation,
BfArM application and maintenance of medical products
Bundesinstitut für Arzneimittel und Medizinprodukte according to § 3 of the Medical Devices Directive with
the exception of medical products for clinical evaluation
BGV A1
or performance evaluation.
Trade association regulations – Principles of Prevention
(Beufsgenossenschaftliche Vorschriften) Network adapter
An adapter to connect the log printer MELAprint®42 to
CF card
the device's Ethernet data connection; the printer
Compact Flash-Card; memory card for digital data with
connection is located on one side, the connection jack
compact size;
for a network cable is located on the other side.
CF is a standard, i.e. this memory cards can be used in
any device with a CF-slot. The CF card can be read and RKI
possibly written by every device that supports the Robert-Koch-Institut
standard.
Software
Conductivity Non-material component of IT systems e.g. a computer
Is the opposite of electrical resistance; measured in program
micro-Siemens/centimetre (µS/cm); the greater the
Solid
amount of dissolute matter in the water, the better it can
Without hollows or spaces; firm, dense, closed
conduct electrical current and thus the higher its
conductivity. TCP
(transmission control protocol) refers to a standard
Contamination
protocol for connecting computers and networks.
(lat. contaminatio = impurification) Impurification through
undesirable outside materials, e.g. microorganisms, VDE
bacteria, blood etc. Verband der Elektrotechnik, Elektronik und
Informationstechnik e.V.
Corrosion
The chemical alteration or destruction of metal materials
by water and process agents.
Denaturising
The structural alteration of bio-molecules, here proteins
through high temperatures.
DGKH
Deutsche Gesellschaft für Krankenhaushygiene e.V.
DGSV
Deutsche Gesellschaft für Sterilgutversorgung (German
Association for the Sterilized Equipment Ordinance). The
DSGV training centres are specified in DIN 58946, part 6
as "Requirements of personnel".
Display
Display device on electronic devices; here: a two row
display
DI-Water
De-ionised water
FTP
(File Transfer Protocol) is a data transmission procedure
serving to transport data from the internet. These data
can contain programs, files or information. Special FTP
programs (FTP clients) serve for uploading any data on a
server.

59
MELAG Medizintechnik oHG
Geneststraße 6-10
10829 Berlin
Germany
E-Mail: info@melag.de
Web: www.melag.de
BA_EN_10DT_v8.docx | Rev.: 8 – 14/1073

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