Summary of Contents for MELAG MELAtherm 10 Evolution
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3.0.19 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.
Contents Contents 1 General guidelines ................................ 5 Symbols used.................................. 5 Formatting rules ................................... 5 Disposal .................................... 5 2 Safety..................................... 6 3 Performance specifications .............................. 8 Intended use .................................. 8 User benefits .................................. 8 Program sequence................................ 9 Process agents .................................. 10 4 Description of the device.............................. 11 Scope of delivery................................ 11 Views of the device ................................ 12 Symbols on the device ............................... 14 Operating panel and acoustic signal .......................... 15 Menu structure ................................... 18...
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Contents 7 Logging .................................... 41 Batch documentation ................................. 41 Output media.................................. 41 Outputting logs immediately and automatically........................ 42 Subsequent log output ............................... 43 Deleting the saved logs.............................. 44 Determining the format for the program logs ........................ 45 Finding the logs.................................. 47 8 Settings .................................... 48 Menu settings.................................. 48 Log settings.................................. 49 Setting the date and time .............................. 54 Setting the display brightness ............................ 56 Setting the idle mode ................................. 56...
Please store these user manual carefully and in close proximity to your device. It represents a compo- nent of the product. Should the user manual no longer be legible, damaged or lost, please obtain a new copy from MELAG. State the device type and your address in an e-mail.
Use only original MELAG accessories or those from other suppliers authorized for use by MELAG. When using non-MELAG accessories for the mounting of instruments (especially hollow-body instru- ments) comply with the manufacturer’s information.
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Only ever operate the device with the basis basket provided for this purpose. Never operate the device unattended. Unsupervised operation of the device can result in damage to the device or your facility and is performed at your own risk. In such a case, MELAG does not accept any liability.
3 Performance specifications 3 Performance specifications Intended use The MELAtherm 10 Evolution DTA/DTB is intended for use in a medical context such as a clinic or medical and dental practices. EN ISO 15883-1 and 2 defines it as a washer-disinfector intended for reprocessing medical instruments prior to their re-use or a further reprocessing step such as sterilization in a steam sterilizer.
3 Performance specifications Metering monitoring The required amounts of cleaning agent and neutralizer are measured out using a hose metering pump. A measurement turbine performs flow monitoring. The rinse aid is metered using a hose pump subject to monitoring for rotation speed. Drawer for process agents The drawer for the process agents is located in the lower area of the device in which the cleaning agent, neutralizer and rinse aid containers are stored.
4 Description of the device Scope of delivery Please check the scope of delivery before setting up and connecting the device. Standard scope of delivery ▪ MELAtherm 10 Evolution Washer-Disinfector ▪ User manual ▪ Technical manual ▪ Record of installation and setting up ▪...
4 Description of the device Views of the device Operating and display panel Cover plate (optional) Power switch Cover cap for CF card slot and Ethernet data connection (for service technician) Door handle Hinged door, opens forwards Ventilation slots for air egress Grip for the drawer Drawer for process agents Device foot...
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4 Description of the device Demineralized water (DI water) connection Cold water connection Wastewater connection Transport rollers Ethernet data connection for permanent network connection Mains cable Fig. 3: View from rear Injector rail connection fitting Cold water (CW) inflow and demineralized (DI) water Salt container Lower rinse arm Coarse and fine sieve...
- it must be delivered to the vendor to be disposed of. 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...
The serial number of the device and the number (ID) of the event will be displayed following warning and malfunction messages. This is the information that can be transferred to MELAconnect via QR code or which can be transferred manually in the troubleshooting area of the MELAG website, in order to access context-dependent troubleshooting assistance.
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4 Description of the device LED display and acoustic signals The LED display to the left and right of the the main area issues a colour to indicate the operating state. An acoustic signal is associated with the colour of the LED display and indicates an expected event. Colour of the LED Meaning Blue...
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Meaning Documentation Additional markings that indicate the availability of assistance (e.g. in the user manual, in MELAconnect or on the troubleshooting area in the MELAG website) regarding the issue with which the current QR code message is concerned. Action bar...
4 Description of the device Menu structure Main menu Universal-Program Quick-Program Intensive-Program Ophthalmo-Program Rinsing Emptying Conductivity measurement DI Air removal Regeneration Time metering 60 s Log output Output internal log memory Select output medium: automatic / CF card / MELAprint /Computer All logs Last log All malfunction logs...
4 Description of the device Water softening unit The tap water is processed in the internal water softening unit to produce an optimal cleaning outcome. Use coarse-grain regeneration salt (NaCl) to regenerate the water softening unit. Water hardness conversion table °dH mmol/l °f °e...
The record of installation and setting up is to be completed by the responsible stockist and a copy sent to MELAG as proof of the correct set-up, installation and initial commissioning. This is a constituent part of any guarantee claim.
5 First steps Video tutorials The Multimedia menu contains video tutorials which describe the use of this washer-disinfector in a number of operating situations. View of the video control Description Description Start/Pause Close video Fast forward Volume louder Fast rewind Volume lower Access a video as follows: ü...
▪ Locating malfunctions and accessing solutions and assistance immediately ▪ Performing quick paperless documentation of routine checks of MELAG sealing devices ▪ Contacting the service technician (contact data must be entered manually) In order to connect the MELAconnect app with your MELAG device, see the Connectivity [} page 58] sec- tion.
5 First steps Proceed as follows to perform emergency door opening: Pull out the process agent drawer. Ê An emergency opening grip is located in the front left-hand side of the device. Pull down on the grip until you hear a clicking sound. Pull the door forwards strongly using the grip.
5 First steps Filling the regenerating salt CAUTION Danger of injury from insufficient protective measures! Performing work without first taking the corresponding protective measures can result in injuries. Comply with the working safety measures required by the respective tasks. NOTICE Malfunctions of the water softening unit from unsuitable regenerating salt.
5 First steps Open the lid of the salt container by turning it anti- clockwise. Insert the filling funnel for the regenerating salt in the opening. Fill the salt container with regenerating salt using the filling funnel. Clean the edge of the filling opening of salt residue. Remove the filling funnel and screw on the lid of the salt container.
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 absence or insufficient filling level of a certain process agent means will trigger the display of the corresponding display message.
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5 First steps Change the containers for cleaning agent and neutralizer Unscrew the suction lance from the container and place it in the suction lance bracket. Place the new container in the process agents drawer and screw on the suction lance. Ê...
5 First steps Transfer the rinse aid from the original packaging into the MELAG container. Ê Use the container tap (for 5 l and 10 l container) included in the scope of delivery for ease of filling. Ê Fill the container with rinse aid ¾ full, otherwise the rinse aid will overflow during insertion of the suction lance.
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 lines to hollow-body instruments are maintained without kinking and as short as possible.
Reprocess only those hollow-body instruments which guarantee sufficient and reproducible rinsing. Remove instruments with a recognisably reduced throughflow. Use only MELAG adapters (accessories list) for the injector rail to reprocess hollow-body instruments. The suitability of the hollow-body instruments for the respective adapter and the sufficient flushing of the instruments can only be proven by validation.
6 Cleaning and disinfection Reprocessing dental transmission instruments Comply with the following specifications before automatic reprocessing: The exterior surfaces of the handpieces should be free of all residue e.g. dental cement. The air and spray channels must be entirely clear. Avoid the drying-on of soiling, especially on the handpieces.
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6 Cleaning and disinfection If present, remove the rinse aid container from the process agents drawer and hang the black suction lance in the suction lance bracket so that the cover is positioned at the top. The suction lance only needs to be placed head- first in the suction lance bracket if the metering hoses are to be bled, see Removing air from the...
6 Cleaning and disinfection Overview of programs Select the program according to the level of soiling of the load. Comply with the specifications from the validation. The Universal-Program is sufficient for every-day general cleaning and disinfection. The Quick- Program is designed for lightly soiled instruments. The following table lists the correct program for each load.
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.
6 Cleaning and disinfection Manual program abort NOTICE Cancellation of a current program by deactivation at the power switch may cause damage at the device. Never abort a program by switching off at the power switch. Abort the program during drying WARNING Nucleation because of poor drying.
6 Cleaning and disinfection Aborting the program before the start of drying WARNING Danger of infection from program abort. If a program is interrupted before the start of a drying phase, the load is taken as not having been cleaned and disinfected. This endangers the health of the patient and the practice team.
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6 Cleaning and disinfection Enter your four-digit user PIN and press the CONFIRM key. Ê The door will be unlocked. Ê The Approve batch window will be displayed. Press the DETAILS key to obtain Assessment criteria for batch approval. Press the FORWARD key and read the assessment criteria carefully.
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6 Cleaning and disinfection Press the DETAILS key to obtain Assessment criteria for batch approval. Press the FORWARD key and read the assessment criteria carefully. Check the reprocessed batch using the assessment criteria outlined. Press the LEAVE key to return to the Approve batch window.
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6 Cleaning and disinfection Skip authentication If both batch approval and authentication have been activated, you will automatically be requested to evaluate the batch and provide it with approval after the reprocessing program has been completed suc- cessfully. You can skip authentication and proceed in the process. PLEASE NOTE Skipping authentication means that the batch will automatically be evaluated as not having been approved.
6 Cleaning and disinfection 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. Allow the device to cool before removing the instruments. Wear suitable protective gloves.
[} page 49]). If the program is con- tinued, the logs are deleted automatically; the last ten saved logs remain in the log memory. MELAG recommends outputting logs immediately. Output media You can output the logs of the finished programs via the following output media: ▪...
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.
7 Logging In the Settings > Log settings > a minimum of one output medium has been selected and Immediate output has been set to yes. The activated output medium is available (e.g. the MELAprint 42/44 log printer or CF card). Graphic logs (optional) The following requirements must be fulfilled in order to record graphic logs: In the Settings >...
7 Logging Press the FORWARD key, until the desired log type e.g. Last log, All malfunction logs etc. is displayed. Press the OUTPUT key to start log output. Deleting the saved logs Proceed as follows to delete the saved logs: Save the log on an output medium before deleting Working in the main menu, press the FORWARD or BACK key until the Log output menu is displayed.
7 Logging Determining the format for the program logs The log format enables you to determine which of the data saved in the log memory is to be outputted. You can choose between the formats 0, 1 and 2. The log format 2 is the standard format. Working in the Settings menu, you can select the log format for the program log (see Log settings [} page 49]).
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>> Never change code in following row << Proof of authenticity: 0100002C1B4802BE0306064C0B3C0AD0130D9610 Must never be changed; permits inference that 07BD3EFECA15229618881B257A98850427217323 the data was created on a MELAG device and 930815C1C892292E3965C071864442576F5F38AC has not been changed. 648A82A3945A3D404141440157A94648AE494AEC >> Proof of authenticity batch log <<...
7 Logging Finding the logs PLEASE NOTE Do not rename the directories, otherwise logs will be stored in both the renamed directory as well as the device directory which the device generates automatically. All memory media (CF card or computer) contain a directory with the encoded serial number of the device concerned following log output.
8 Settings 8 Settings Menu settings In the Settings menu you can set parameters such as the date, time or display brightness. The following sequence describes general steps for performing settings. Working in the main menu, press the FORWARD or BACK key until the Settings menu is displayed.
8 Settings Press the YES key to save the settings. Press the NO key to discard the settings. PLEASE NOTE Not all the settings made are saved immediately and automatically, but only upon leaving the Settings menu. Pressing the YES key, saves the settings. Pressing the NO key means that the settings are not saved.
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8 Settings Press the FORWARD or BACK key to navigate between yes and no. Press the CONFIRM key to accept the change. Immediate output If you have set an output medium for logging, immdiate output must also be activated. If immdiate output is not active, then none of the output media pre-determined for automatic logging will be used.
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8 Settings Press the EDIT key, if this parameter is to be changed. Press the FORWARD or BACK key to navigate between the formats 0, 1 and 2. Press the CONFIRM key to accept the change. For comprehensive information regarding the log formats 0, 1 and 2, see Determining the format for the program logs [} page 45].
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8 Settings MELAtherm IP, computer IP, MELAprint IP, gateway IP, subnet mask This example demonstrates how to set the MELAtherm IP. The computer IP, MELAprint IP, gateway IP or subnet mask are set in the same fashion. ü The Settings > Log settings > Network menu is open. Working in the Network submenu, press the FORWARD or BACK key until the MELAtherm IP window is displayed.
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8 Settings Press the EDIT key. Press the FORWARD or BACK key to navigate between 0 (FTP) and 1 (TCP/IP). Press the CONFIRM key to accept the change. FTP password, TCP port This example demonstrates how to set the FTP password. The TCP port is set in the same fashion. ü...
8 Settings Outputting graphic logs Working in the Graphic logs submenu, you can select the output medium for automatic logging of graphic logs. The following example describes how to select a CF card as an output medium for graphic logs. The selection of a different or a further output medium is performed in accordance with the same procedure.
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8 Settings Press the CONFIRM key to open the submenu. Press the EDIT key. Press the FORWARD or BACK key to change the parameter. Press the CONFIRM key to accept the change. Setting the time The following example demonstrates the setting of the hour parameter. Proceed in the same fashion to set the minute and second parameters.
8 Settings Press the CONFIRM key to accept the change. Setting the display brightness Proceed as follows to set the display brightness: ü The Settings menu is open. Working in the Settings menu, press the FORWARD or BACK key until the Display brightness parameter is displayed.
8 Settings Press the FORWARD or BACK key to change the parameter. Press the CONFIRM key to accept the change. Setting the volume of the signal tone Proceed as follows to set the volume of the signal tone: ü The Settings menu is open. Working in the Settings menu, press the FORWARD or BACK key until the Signal tone volume is displayed.
Alternatively, you can enter the IP address of your device in the MELAconnect app manually. With manual entry of the IP address: Owners of multiple MELAG devices of the identical type can differentiate between their devices by viewing serial number on the display to check whether MELAconnect has been connected...
8 Settings Setting the language Proceed as follows to set the language: ü The Settings menu is open. Working in the Settings menu, press the FORWARD or BACK key until the Language window is displayed. Press the EDIT key. Press the FORWARD or BACK key to change the parameter.
8 Settings Press the FORWARD or BACK key to change the parameter. Press the CONFIRM key to accept the change. Setting the water hardness PLEASE NOTE The service technician determines and sets the water hardness during device commissioning. Proceed as follows to set the water hardness: ü...
8 Settings Administrative settings Working in the Administration submenu, the administrator can assign user PINs to existing user IDs and can activate or deactivate the authentication and batch approval. Logging on as an administrator Proceed as follows to log on as an administrator: ü...
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8 Settings User Twenty user IDs have been specified in the Settings > Administration > User menu. The administrator can assign a user PIN to every user ID and edit it. Every user PIN consists of four digits. Creating and assigning a new user PIN In its delivery state, the user IDs 2 to 20 have not been assigned a PIN.
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Changing an existing admin/user PIN In its delivery state, the admin PIN is set to 1000 as standard. MELAG recommends that you change the admin PIN upon commissioning. The admin PIN (user ID 1) can be changed just as a user ID (user ID 2-20).
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8 Settings Deleting the user PIN Proceed as follows to delete a user PIN: ü You are working in the Settings > Administration > User menu and are logged on as an administrator, see Administrative settings page 61]. Working in the User submenu, press the FORWARD or BACK key until the user ID (from 2 to 20) is displayed with the PIN to be deleted.
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8 Settings Press the FORWARD key. Ê The setting changes from inactive to active. Press the CONFIRM key to accept the change. Ê Authentication has been activated. The log states User ID: ##. Deactivating authentication Authentication is deactivated in the same way as it is activated. Ê...
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8 Settings Press the CONFIRM key to accept the change. Ê Batch approval has been activated. The log states Approve batch: YES or NO. Deactivating batch approval Batch approval is deactivated in the same way as it is activated. Ê The setting changes from active to inactive.
9 Function tests 9 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.
10 Maintenance 10 Maintenance WARNING All servicing work, especially that performed in the washing chamber may only be performed after a successful disinfection program. Comply with the working safety regulations. Regular 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.
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10 Maintenance Check the rinse arms Soiling can block the nozzles of the rinse arms. Check both rinse arms regularly and rinse the nozzles if necessary. Check that the coarse and the fine sieves are installed. Turn the knurled nut on the rinse arm leftwards and remove the rinse arm.
10 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.
10 Maintenance Changing the 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.
[} page 10]) may cause an increased effort for validation / performance requalification. ▪ We cannot provide a guarantee for non-MELAG accessories, even if they are in possession of validation. ▪ The validator and technical service can download a “Recommendation for validating the MELAtherm 10...
▪ Decommission the device if you plan to have a pause of over two weeks. Decommissioning Preparation for transport Decommissioning in preparation for transport outside the practice should only be undertaken by MELAG- authorized individuals. Following longer operating pauses WARNING Danger of acid burns by irritant substances! Improper handling of the process agents may cause caustic burns and health damage.
11 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 comply with these provisions can result in crushing. Comply with the safety regulations issued by your professional association. Comply with the following provisions pertaining to transport within the practice: Empty the device entirely.
Not all notifications on the display are malfunction messages. Messages are issued on the display with an event number. The number serves identification purposes for obtaining assistance on the MELAG website (Service > Troubleshooting), the MELAconnect app and when communicating with the authorized custom- er services or the stockist technician.
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, the event number and/or a detailed description of the message contained in the notification to hand.
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12 Malfunctions Event Possible cause Remedy White layer on the The internal water softening unit has not Check the water hardness of the tap instruments been programmed correctly. water and reset the internal water softening unit if necessary, see Description of the device [} page 11].
Insert a new CF card (max. 4 GB) in the was inserted in the slot under voltage. card slot. The MELAG logo must point rightwards during insertion. MELAG recommends using original accessories...
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The CF card is not functioning correctly and Insert a new CF card (max. 4 GB) in the card cannot be formatted. slot. The MELAG logo must point rightwards during insertion. MELAG recommends using original accessories only. The CF card does not function correctly.
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Settings menu, the Computer parameter is set to yes (active). The MELAG device is not connected to a Working in the display, select the computer, but in the Settings > Log Settings > Log settings menu and settings menu, the Computer parameter deactivate the Computer parameter.
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Setting the date and time [} page 54]. The CF card does not function correctly. Insert a CF card with a memory of up to 4 GB. The MELAG logo must point There is no CF card in the slot. rightwards during insertion. MELAG recommends using original accessories only.
12 Malfunctions Event Possible cause Remedy The temperature in the washing chamber is CAUTION! The instruments are hot. very high. The door is blocked and cannot be Press the YES key, to acknowledge the unlocked immediately. message. The door can be opened. PLEASE NOTE: Take suitable safety precautions when opening the device, such as standing at a safe distance and wearing...
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12 Malfunctions Event Possible cause Remedy The fan of the display is not functioning Switch the device off and then on again. correctly. Start the program again. The fan of the diffuser is not functioning Switch the device off and then on again. correctly.
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12 Malfunctions Event Possible cause Remedy The rinse aid metering pump is not functioning Switch the device off and then on again. correctly. The metering system may be Start the program again. blocked. The solenoid valve for the cold water does not Switch the device off and then on again.
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12 Malfunctions Event Possible cause Remedy No neutralizer is pumped. Replace the neutralizer container, working in accordance with the working safety The neutralizer container has been exhausted regulations. Alternatively, refill. or is nearly empty. NOTICE! Use only process agents which you have used before. Start the "Air removal"...
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12 Malfunctions Event Possible cause Remedy The temperature difference between the two Clean the upper rinse arm and check its ease temperature sensors in the washing chamber of movement. is too great. The temperature sensors were not covered with water sufficiently. The upper rinse arm revolves too slowly.
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12 Malfunctions Event Possible cause Remedy The rinse pressure in the washing chamber is Check the water inflow of the device. Open the too low. water inflow tap completely. The water inflow is insufficient. The basis basket has been inserted incorrectly Insert the basis basket in the washing or not at all.
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12 Malfunctions Event Possible cause Remedy The emergency release on the door was WARNING! The load of the interrupted actuated during a program run. program has not been cleaned or disinfected. Acknowledge the message with the CONFIRM key. Close and lock the door correctly. Start the program again.
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12 Malfunctions Event Possible cause Remedy The collection tank is not pumped out. Switch the device off and then on again. Start the program again. The temperature during pre-cleaning is too Check the water supply to the device. high. The coarse or fine sieve is soiled. Remove and clean the coarse and fine sieve, see Regular checks and cleaning...
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12 Malfunctions Event Possible cause Remedy Water is in the pump pit after pumping out. Remove and clean the coarse and fine sieve, Regular checks and cleaning [} page 68]. The coarse or fine sieve is soiled. The non-return valve in the pump pit is Insert the non-return valve in the pump pit missing or has been fitted incorrectly.
13 Technical data 13 Technical data MELAtherm 10 Evolution DTA/DTB device dimensions Device type Semi-integrated unit Free standing Top-frame device Device dimensions 81.8 x 59.8 x 68.1 cm 83.6 x 59.8 x 68.1 cm 124 x 59.8 x 68.1 cm...
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13 Technical data Device type MELAtherm 10 Evolution DTA MELAtherm 10 Evolution DTB Wastewater Wastewater connection DN21 Max. wastewater temperature 93 °C (< 1 min, approx. 7 l) Amount of wastewater per hour approx. 38 l (in short intervals) Capacity of drain pump max.
14 Accessories and spare parts 14 Accessories and spare parts You can obtain the specified articles together with an overview of further accessories from your stockist. Information regarding the instrument reprocessing accessories can be found in the current MELAG price list. Article Art.
15 Documentation and approval 15 Documentation and approval Personal number Device number Batch number Program/ Process Process Approval Remarks Signature load successful? approval? instruments? Reprocessed on partially Reprocessed on partially Reprocessed on partially Reprocessed on partially Reprocessed on partially Reprocessed on partially Reprocessed on partially...
The term “authorized technician” refers to an em- ployee of a customer service provider or stockist Process agents who has been trained and authorized by MELAG A process agent is a composition of chemical com- to perform maintenance and installation work on pounds for designed for reprocessing purposes MELAG devices.
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MELAG Medizintechnik oHG Geneststraße 6-10 10829 Berlin Germany Email: info@melag.com Web: www.melag.com Original instructions Responsible for content: MELAG Medizintechnik oHG We reserve the right to technical alterations Your stockist...
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