MELAG MELAtherm 10 User Manual

Washer-desinfector

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Service manual (215 pages)

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Page 1 1.309 Dear doctor, We thank you for your confidence demonstrated by the purchase of this MELAG product. As an owner-run and operated family concern founded in 1951, we have a long history of successful specialization in hygiene products for practice- based use.
Page 3: Table Of Contents
Contents Contents 1 General safety information .............................. 5 2 Scope of delivery.................................. 7 3 General Guidelines................................ 8 User group and validity ................................ 8 Intended use .................................. 8 Symbols used.................................. 8 Formatting rules ................................... 8 Symbols on the device ................................. 9 Disposal .................................... 9 4 Performance specifications .............................. 10 User Benefits.................................. 10 Program sequence................................ 11 Approved process agents .............................. 11 5 Description of the device.............................. 13...
Page 4 Contents Decontaminating ophthalmological instruments......................... 32 Overview of programs ................................ 33 Selecting, starting and following the program ........................ 34 Manual program abort................................ 36 Removing the load after program end.......................... 37 9 Logging .................................... 38 Batch documentation ................................. 38 Output media.................................. 38 Outputting logs immediately and automatically........................ 40 Subsequent log output ............................... 41 Deleting the saved logs.............................. 41 Determining the format for the program logs ........................ 41 Finding the logs.................................. 44...
Page 5: General Safety Information
Handle all process agents with care. The cleaning, neutralization and rinsing aids contain irritants and even caustic substances. Use only those process agents approved by MELAG for this device. Observe the operating and safety information from the process agent manufacturer. If, despite observation of the manufacturer's inform-...
Page 6 The use of process agents not approved by MELAG absolves MELAG of all liability whatsoever for any damage to the device or the instruments.
Page 7: Scope Of Delivery
2 Scope of delivery 2 Scope of delivery Please check the scope of delivery before setting up and connecting the device. Standard scope of delivery ® ▪ Washer disinfector MELAtherm ▪ User manual ▪ Technical manual ▪ Record of installation and set-up ▪...
Page 8: General Guidelines
3 General Guidelines 3 General Guidelines Please read this user manual carefully before commissioning the device. The operating manual includes important safety information. The functionality and value-retention of this device depend primarily on the care accorded to it. Make sure to keep the User Manual close to the device. It represents a component of the product.
Page 9: Symbols On The Device
Disposal MELAG devices are synonymous for long-term quality. When you eventually need to decommission your MELAG device, we offer a special disposal service. Simply contact your stockist. The packaging protects the device against transport damage. The packaging materials have been selected for their environmentally-friendly and recycling properties and can be recycled.
Page 10: Performance Specifications
4 Performance specifications 4 Performance specifications 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 in according to the (German) RKI directive.
Page 11: Program Sequence
The use of process agents not approved by MELAG absolves MELAG of all liability whatsoever for any damage to the device or the instruments. The following combinations of process agents were tested for suitability for use with MELAtherm 10, brought into circulation since 01-07-2012:...
Page 12 4 Performance specifications Manufacturer Cleaner Neutralizer Rinse aid Alpro* TR-3 TR-Neutralizer TR-Clear B. Braun Helimatic cleaner alkaline Helimatic neutralizer C Helimatic rinse neutral Bode Dismoclean 21 clean Dismoclean 25 acid Dismoclean 64 neutra-dry Borer* deconex 28 ALKA ONE-x deconex 25 ORGANACID deconex 64 NEUTRADRY deconex 22 LIQ-x deconex 26 MINERALACID...
Page 13: Description Of The Device
5 Description of the device 5 Description of the device Views of the device Operating and display field Cover plate (optional) Power switch Cover for CF card slot and Ethernet data interface (for service) Door grip Hinged door, opens forwards Drawer handle Drawer for process agents Ventilation slots...
Page 14 5 Description of the device Connection for de-ionised water (DI water) Connection for cold water Effluent connection Transport rollers Ethernet data connection for permanent network connection Mains power cable Fig. 3: View from rear Connection tube for injector rails Cold water inflow (CW) and deionised water (DI) Salt container Lower rinse arm...
Page 15: Operating Panel And Acoustic Signals
Fig. 5: Process agent drawer, open Operating panel and acoustic signals The control panel consists of a two-line LED display and four membrane keys. MELAG MELAtherm 10 Fig. 6: 2-row LED display Table 1: Key functions Function/Explanation 1...2 Navigation: BACKWARDS - FORWARDS...
Page 16: Menu Structure
5 Description of the device Acoustic Signals The device issues acoustic signals for information purposes. Table 2: Acoustic Signals Signal / tone Meaning Confirmation, warning or message Refill with salt soon; program abort; end of the abort after drying abort reached Program completed successfully Malfunction Menu structure...
Page 17: Water Softening Unit
5 Description of the device Water softening unit The tap water is processed in a water softening unit to produce optimal cleaning results. Use coarse-grain regeneration salt (NaCl) to regenerate the water softening unit. NOTICE The fitted water softening unit has been optimized for a degree of hardness of 0–40°dH. For higher degrees of hardness than 40°dH, you will require a dedicated water softening unit.
Page 18: Settings
6 Settings 6 Settings SETUP menu The setup menu contains settings for the date, time and display contrast. Navigate in the setup menu as follows: Press to navigate in the main menu to M02->SETUP-MENU. Press to open the setup menu. Press to leave the setup menu.
Page 19: Setting Date And Time
6 Settings Press to open the menu 02 Automatic logging. Ê The selectable output media are displayed consecutively. Press repeatedly to navigate in the setup menu to 01 CF card YES . Ê The display of YES indicates that the log is to be saved on the CF card. Press if this value is to be changed.
Page 20: Setting The Display Contrast
6 Settings Setting the time Working in the SETUP menu [} page 18] set the time as follows: Press repeatedly to navigate to 04 Time. Press in order to change the language. Ê The display changes to 04 Change date. Press to activate the selected parameters.
Page 21: Setting The Water Hardness
The selected value is automatically saved when leaving the setup menu. Other languages can also be installed. To this end, the corresponding language update file must be downloaded on the device from the CF card. Please consult your MELAG customer services or stockist for this.
Page 22: First Steps
The responsible stockist is to complete the record of installation and setup as proof of the correct setup, installation and commissioning. A copy is to be sent to MELAG oHG and the stockist. This is a constituent part of any guarantee claim.
Page 23: Emergency Release Of The Door
7 First steps Opening the door Switch on the device at the power switch. Press the key. Ê The door is unlocked. Open the door forwards to open. Closing the door Shut the door upwards and press it until the motorized lock sets in. Emergency release of the door CAUTION Danger of scalding from hot steam.
Page 24: Inserting The Basis Basket
7 First steps Inserting the basis basket A port for the connection of the injector rail is located on the right-hand rear side of the washing chamber of the washer-disinfector. Slide the basis basket with the injector rail opening into the washing chamber until it connects to this port. Filling the regeneration salt CAUTION Danger of injury from insufficient protective measures!
Page 25: Regenerating The Water Softening Unit
7 First steps You can refill the regenerating salt at any time without the corresponding display notification. After filling, start the supplementary “Rinse” program to remove overflowing brine and salt residue from the washing chamber. In order to refill the regeneration salt, proceed as follows: Acknowledge the notification Refill with salt soon with the key.
Page 26: Metering Process Agents
NOTICE Damage to instruments and the device from unsuitable process agents! Use only those process agents approved by MELAG for use in this device. Comply with the information from the process agent manufacturer. An insufficient filling level of a certain process agent means will trigger the display of the corresponding display message.
Page 27 7 First steps Containers for process agents Every process agent has its own container and a suction lance with screw-on lid: ▪ Cleaning agent: 5 L container with a blue suction lance screw-on lid ▪ Neutralizer: 5 L container with a red suction lance screw-on lid ▪...
Page 28: Bleeding The Metering Hoses
Unscrew the suction lance from the container and place it in the bracket behind it. Transfer the rinse aid from the original packaging into the MELAG container. Ê Use the drain tap included in the scope of deliv- ery for ease of filling.
Page 29 7 First steps ü The “Air removal” program must be started twice after initial filling of the container. Insert the suction lance of the non-used process agent head-first in the suction lance bracket before the program start. Press the key repeatedly to navigate to Z04 Air removal in the main menu.
Page 30: Cleaning And Disinfection
Further accessories may be required when reprocessing ophthalmological instruments (not available from MELAG). The operator is responsible for validating the procedure in combination with special load accessories It is especially important that feed lines to hollow-bodied instruments are maintained without kinking and as short as possible.
Page 31: Decontaminating Hollow-Bodied Instruments
Treat only those hollow-bodied instruments which guarantee sufficient and reproducible rinsing. Re- move instruments with a recognisably reduced throughflow. Use only MELAG adapters (accessories list) for the injector rail to treat hollow-bodied instruments. The suitability of the hollow-bodied instruments for the respective adapter and the sufficient flushing of the instruments can only be proven by validation.
Page 32: Decontaminating Dental Transfer Instruments
(contact with retinal tissue, sub-retinal fluid and the optical nerve). These devices should be fitted with a suitable filter system: Ophthalmological instruments may only be treated using the filter discs (MELAG art. no. 64375). NOTICE Use only those instruments designed by their manufacturer for automatic treatment in a washer-disinfector.
Page 33: Overview Of Programs
8 Cleaning and Disinfection Suitable program Treat ophthalmological instruments in the Ophthalmo-Program. Only this program enables monitoring of the conductivity during the disinfection phase; this ensures an uncritical residual conductivity. Comply with the following specifications before automatic treatment: Cleaning should be undertaken with a mildly alkali cleaner. Neutralization should be effected with a cit- ric acid based neutralizer.
Page 34: Selecting, Starting And Following The Program
Selecting, starting and following the program NOTICE Unsupervised operation of the device can result in damage to the device or your facility. In such a case, MELAG does not accept any liability. Never operate the device unattended. Unattended operation is performed at the operator’s risk.
Page 35 8 Cleaning and Disinfection Ensure compliance with the following prerequisites in order to secure the optimal cleaning performance before every program start: The process agents containers are sufficiently full. The injector rail nozzles / adaptor are clean. The rinse arms can be turned freely. The load must be arranged correctly.
Page 36: Manual Program Abort
8 Cleaning and Disinfection Manual program abort NOTICE Cancellation of a current program by deactivation at the power switch may cause dam- age at the device. Never abort a program by switching off at the power switch. Abort the program during drying CAUTION Danger of burns from hot instruments and surfaces.
Page 37: Removing The Load After Program End
8 Cleaning and Disinfection Press the key to abort a current program before drying begins and follow the information on the display. Removing the load after program end CAUTION Danger of burns from hot instruments and surfaces. The instruments and chamber can remain hot even after the device has been switched off.
Page 38: Logging
9 Logging 9 Logging Batch documentation The batch documentation acts as proof of the successful conclusion of the sterilization process and represents an obligatory part of quality control. 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.
Page 39 Open the CF card cover cap. Insert the CF card in the slot with the contacts at the front. The MELAG logo on the CF card points towards the LED. Slide the CF card in the card slot until it clicks. Do not use force.
Page 40: Outputting Logs Immediately And Automatically
9 Logging Outputting logs immediately and automatically As delivered, the MELAflash CF card is set as an output medium in the setup menu and thus the automatic log output at the end of a program (immediate output = YES) is thus activated. Log output on multiply activated media is performed successively.
Page 41: Subsequent Log Output
9 Logging 03 Graphic logs PC-backup 00030 Subsequent log output The Docu menu provides the option of issuing logs subsequently and independently of the point of the program end. Proceed as follows: Press to navigate to the DOCU MENU. Press to open the DOCU MENU.
Page 42 9 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. Table 6: Overview of log types Ending Stands for...
Page 43 9 Logging Example of a program log for a successful finished Program ---------------------------------------- 10 MELAG MELAtherm 10-DTA ---------------------------------------- 15 Program: Ophthalmo-Program 20 TARGET °C 21 Pre-clean: 22.0 01:30 23 Cleaning : 55.0 10:00 Header: Device name 28 Disinfect: 90.0 05:00...
Page 44: Finding The Logs
9 Logging Finding the logs PLEASE NOTICE Do not rename the directory, otherwise logs will be stored in both the renamed directory as well as the new device directory generated automatically by the device. All storage media (CF card or computer) contain a directory with the encoded serial number of the device concerned following log output.
Page 45: Function Tests
10 Function tests 10 Function tests Automatic and manual functional check Automatic The device components are monitored and checked automatically for their functionality and interplay. Should the parameter thresholds be exceeded, the device will issue warnings or malfunction messages. If necessary, it will abort a program with the relevant notification.
Page 46: Maintenance
11 Maintenance 11 Maintenance DANGER All servicing work, especially that performed in the washing chamber may only be per- formed after a successful disinfection program. Comply with the working safety regulations. Daily checks and cleaning NOTICE Incorrect cleaning can damage the surfaces and sealing faces. Scratched or damaged surfaces and leaking sealing faces favour soiling deposits and corrosion in the washing chamber.
Page 47 11 Maintenance Rinse the soiled sieve under running water. Do not use any dishwashing detergent. Remove deposits with a soft brush. Checking the rinse arms Dirt particles can block the nozzles of the rinse arms. Check both rinse arms regularly and rinse the nozzles if necessary.
Page 48: Cleaning On Demand
11 Maintenance Cleaning on demand Operating unit and plastic front Comply with the following specifications for cleaning: Use a soft, non-fuzzing cloth. Use a chlorine- and vinegar-free cleaning fluid or a plastics cleaning agent. Check the material compatibility before application! Never use solvents or benzene.
Page 49: Maintenance
Maintenance should only be performed by trained customer services technicians, or special- ist 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.
Page 50: (Process) Validation
Please observe all valid national regulations and specifications. In case of doubt, please consult the relevant professional association. ▪ Only use the loading pattern specified and approved within the scope of the validation. ▪ We cannot provide a guarantee for non-MELAG accessories, even if they are in possession of valida- tion.
Page 51: Pause Times
▪ Decommission the device if you plan to have a pause of over two weeks (see ). Decommissioning Preparation for transport Decommissioning in preparation for transport outside the practice should only be undertaken by MELAG- authorized individuals. Following longer operating pauses DANGER Danger of acid burns by irritant substances! Improper handling of the process agents may cause caustic burns and health damage.
Page 52: Transport Within The Practice
12 Pause times Transport within the practice CAUTION Danger of injury from incorrect carrying. Lifting and carrying too heavy a load can result in spinal injury. Failure to observe these provisions can result in crushing. Two people are necessary to carry the device. Please ensure that you comply with the transport instructions.
Page 53: Malfunctions
Should you be unable to find the relevant event, or your efforts do not redress the problem, you can contact your nearest stockist or authorized MELAG customer service provider. Please have your device serial number and a detailed description of the malfunction contained in the malfunction message to hand.
Page 54: Warnings
13 Malfunctions Incident Possible cause Remedy White layer on the The internal water softening unit has Check the water hardness of the instruments not been programmed correctly. tap water and reset the internal wa- ter softening unit if necessary, see Water-insoluble, hardened treatment Description of the device [} page...
Page 55 13 Malfunctions Warning Incident Possible cause Remedy W386 Progr. log memory ▪ If the batch documenta- Check the automatic logging set- almost full Not all logs tion is activated, un-is- tings after the program run. issued. sued logs are stored in Check whether the set output me- the memory.
Page 56: Malfunction Messages
13 Malfunctions Warning Incident Possible cause Remedy W549 Poor DI water quality The MELAdem cartridge is Start the additional program almost exhausted. The conductivity measurement. If the warning is issued above 15 displayed value is under 15 µS, µS. treatment can continue without any further measures.
Page 57 13 Malfunctions Fault Incident Possible cause Remedy F426 The cleaning agent has Replace the cleaning agent con- Air-bubble formation R been exhausted, air is tainer, working in accordance with Start Air removal being transported. the working safety regulations. NOTE No signal from neutralizer The hose to the suction float switch Start the “Air removal”...
Page 58 13 Malfunctions Fault Incident Possible cause Remedy F451 Consult the user manual One of the washing Check the load and re-sort it if F451 chamber temperature necessary. sensors measures an Then re-start the program. incorrect temperature. F464 Check the inflow tap The water inflow tap Open the cold water inflow tap.
Page 59 Check whether the connected pro- to be placed in the bas- cess agents have been approved ket with the opening fa- by MELAG. cing upwards. Other- Check the settings of the metering wise, they take the wa- concentration and if necessary, ar-...
Page 60 13 Malfunctions Fault Incident Possible cause Remedy F531 Emergency unlocking Emergency unlocking PLEASE NOTE The emergency activated during a current release may only be actuated in an program emergency. Clear with the key "4" and close the door. The program must be restarted as the disinfection is not guaranteed.
Page 61 Check whether the connected pro- rinsing. cess agents have been approved Non-cleared process by MELAG. agents (rinse aid or Check the settings of the metering cleaning agent) were concentration and if necessary, ar- used / the metering...
Page 62: Technical Data
14 Technical Data 14 Technical Data Table 7: Device dimensions MELAtherm 10 DTA/DTB Device type Free standing Under-desk unit Cabinet device Dimensions (HxWxD) 83.6 x 59.8 x 67.83 cm 81.8 x 59.8 x 67.83 cm 124 x 59.8 x 67.83 cm...
Page 63: Accessories And Spare Parts
15 Accessories and Spare Parts Accessories You can obtain the specified articles together with an overview of further accessories from your stockist. Information regarding the instrument decontamination accessories can be found in the current MELAG price list. Article Order no.
Page 64: Documentation And Approval
16 Documentation and approval 16 Documentation and approval Personal number Device number Batch number Program/ Process Process Approval Remarks Signature load successful? approval? instruments? Treated on Partially Treated on Partially Treated on Partially Treated on Partially Treated on Partially Treated on Partially Treated on Partially...
Page 65: Glossary
The A0 value depends on temperature and time. Authorized personnel An authorized personnel can be a medical stock- ists, depot technicians or MELAG-authorized cus- tomer services trained by MELAG. Batch Collection of sterilization material which has been processed together in the same sterilization pro- gram.
Page 66 MELAG Medizintechnik oHG Geneststraße 6-10 10829 Berlin Germany E-Mail: info@melag.com Web: www.melag.com Responsible for content: MELAG Medizintechnik oHG We reserve the right to technical alterations Your stockist...

MELAG MELAtherm 10 User Manual

1 General Safety Information

2 Scope of Delivery

3 General Guidelines

4 Performance Specifications

5 Description of the Device

6 Settings

7 First Steps

8 Cleaning and Disinfection

9 Logging

10 Function Tests

11 Maintenance

12 Pause Times

13 Malfunctions

14 Technical Data

15 Accessories and Spare Parts

16 Documentation and Approval

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Table of Contents