MELAG MELAtherm 10 User Manual
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MELAG MELAtherm 10 User Manual

Washer-disinfector
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User Manual
MELAtherm
Washer-Disinfector
from software version 1.311
EN
Dear doctor,
We thank you for your confidence demonstrated by the purchase of this MELAG product. As an owner-run and operated
family concern founded in 1951, we have a long history of successful specialization in hygiene products for practice-
based use. Our focus on innovation, quality and the highest standards of operational reliability has established MELAG
as the world's leading manufacturer in the instrument treatment and hygiene field.
You, our customer are justified in your demand for the best products, quality and reliability. Providing
hygiene"
and
"Quality – made in
management system is subject to close monitoring: one instrument to this end is our annual multi-day audit conducted in
accordance with ISO 13485. This guarantees that all MELAG products are manufactured and tested in accordance with
strict quality criteria.
The MELAG management and team.
®
10
Germany", we guarantee that these demands will be met. Our certified quality
"competence in

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Summary of Contents for MELAG MELAtherm 10

  • Page 1 1.311 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 guidelines ................................ 5 Symbols used.................................. 5 Formatting rules ................................... 5 Disposal .................................... 5 2 Safety..................................... 6 3 Performance specifications .............................. 8 Intended use .................................. 8 User benefits .................................. 8 Program sequence................................ 9 Approved process agents .............................. 10 4 Description of the device.............................. 12 Scope of delivery................................ 12 Views of the device ................................ 13 Symbols on the device ............................... 15 Operating panel and acoustic signals .......................... 16 Menu structure ................................... 17...
  • Page 4 Contents Deleting the saved logs.............................. 39 Determining the format for the program logs ........................ 39 Finding the logs.................................. 42 8 Settings .................................... 43 SETUP MENU.................................. 43 Setting the water supply.............................. 43 Setting automatic logging.............................. 43 Setting date and time ................................. 44 Setting the display contrast .............................. 45 Selecting the language............................... 46 Setting the water hardness .............................. 46 9 Function tests .................................. 47 Automatic and manual functional check.......................... 47...

  • Page 5: General Guidelines

    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.

  • Page 6: Safety

    DIN EN ISO 17664. It is especially important to observe the manufacturer's information regarding cleaning instruments for the first time whilst purchasing new instruments. 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.
  • Page 7 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 infor- mation, the process agents have a negative effect on the material of the instruments or the device, liability lies with the manufacturer of the process agents.

  • Page 8: Performance Specifications

    3 Performance specifications 3 Performance specifications Intended use In accordance with DIN EN ISO 15883-1 and -2, this device is a washer-disinfector intended for use in a medical context such as clinics and medical and dental practices. You can subject thermostable medical instruments (i.e.

  • Page 9: Program Sequence

    Finally, the process water is pumped out of the washing chamber. Disinfection The actual disinfection is performed after intermediate rinsing. The disinfectant effect of MELAtherm 10 is achieved using thermal disinfection and subsequent drying.

  • Page 10: Approved 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.
  • Page 11 3 Performance specifications Preset metering concentrations PLEASE NOTE The following setting values are effective from software version 1.311. Program Cleaning agent Neutralizer Rinse aid Universal-Program 6 ml/l 1.5 ml/l 0.3 ml/l Quick-Program 6 ml/l 1.5 ml/l 0.3 ml/l Intensive-Program 10 ml/l 1.5 ml/l 0.3 ml/l Ophthalmo-Program...

  • Page 12: Description Of The Device

    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 Washer-Disinfector ▪ User manual ▪ Technical manual ▪ Record of installation and setup ▪...

  • Page 13: Views Of The Device

    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...
  • Page 14 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 inflow (CW) and demineralized water (DI) Salt container Rinse arm down Coarse and fine sieve...

  • Page 15: Symbols On The Device

    4 Description of the device Drying fan pre-filter Assignment of the process agents Suction lance bracket Container for rinse aid with suction lance Container for neutralizer with suction lance Container for cleaning agent with suction lance Fig. 5: Process agent drawer open Symbols on the device Manufacturer of the medical device Date of manufacture of the medical device...

  • Page 16: Operating Panel And Acoustic Signals

    - it must be delivered to the vendor to be disposed of. Operating panel and acoustic signals The operating panel consists of a two-row LED display and four membrane keys. MELAG MELAtherm 10 Fig. 6: 2-row LED display Key functions Function / Explanation 1...2...

  • Page 17: Menu Structure

    4 Description of the device Menu structure MAIN MENU Universal-Program ├ Quick-Program ├ Intensive-Program ├ Ophthalmo-Program ├ Rinsing ├ Emptying ├ Conductivity DI ├ Air removal ├ Regeneration ├ Time metering 60s ├ └ DOCU MENU (Output of a saved log via the following output media) Select output medium Automatic, CF card, MELAprint, PC ├...

  • Page 18: Water Softening Unit

    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. 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 19: First Steps

    Record of installation and setup The record of installation 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 guaran- tee claim.

  • Page 20: Manual Door Emergency-Opening

    5 First steps Manual door emergency-opening CAUTION Danger of scalding from hot steam. Hot steam could be released upon opening the door. Never operate the emergency door opening mechanism during an active program. Wear suitable protective clothes. WARNING Danger of contamination from insufficient disinfection A program aborted by emergency opening is classed as not having been performed.

  • Page 21: Inserting The Basis Basket

    5 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 22: Regenerating The Water Softening Unit

    5 First steps You can refill the regenerating salt at any time without the corresponding display notification. After filling, work manually to start the supplementary "Rinsing" program in order to rinse away any brine or salt resi- due from the washing chamber. In order to refill the regeneration salt, proceed as follows: Acknowledge the display message Please refill salt soon using the...

  • Page 23: 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 absence or insufficient filling level of a certain process agent means will trigger the display of the corresponding display message.
  • Page 24 5 First steps Containers for process agents Every process agent has its own container and a suction lance with screw-on lid: ▪ Cleaning agent: 5 litre container with a blue suction lance screw-on lid ▪ Neutralizer: 5 litre container with a red suction lance screw-on lid ▪...
  • Page 25 Unscrew the suction lance from the container and place it the bracket behind it. Transfer the rinse aid from the original packaging into the MELAG container. Ê Use the container tap (for 5 litre and 10 litre container) included in the scope of delivery for ease of filling.

  • Page 26: Removing Air From The Metering System

    5 First steps Removing air from the metering system The metering system must be vented after filling the container, performing a product change or removing the suction lances. Air removal removes all air pockets from the hoses and ensures good metering. ü...

  • Page 27: 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 lines to hollow-body instruments are maintained without kinking and as short as possible.

  • Page 28: Decontaminating Hollow-Body Instruments

    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.

  • Page 29: Decontaminating Dental Transmission Instruments

    6 Cleaning and disinfection Decontaminating 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.
  • Page 30 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 need only be placed head-first in the suction lance bracket if the metering hoses are to be bled, see Removing air from the metering...

  • Page 31: Overview Of Programs

    6 Cleaning and disinfection Overview of programs Choose 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.

  • Page 32: 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 33: Manual Program Abort

    6 Cleaning and disinfection Enter the device IP address in the address bar of the Adress bar web browser, e.g. 192.168.70.206 and confirm with of web server enter. Program run Ê The program run and the device information such as e.g. serial number, device software version will be shown.

  • Page 34: Removing The Load After Program End

    6 Cleaning and disinfection Aborting the program before the start of drying 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 35 6 Cleaning and disinfection Remove the load whilst complying with all the hygiene and working safety regulations. PLEASE NOTE Do not leave instruments in the washing chamber over night, otherwise this can result in corrosion of the instruments. The load is only classed as having been cleaned and disinfected if all the following points have been met. Otherwise, reprocess the load afresh.

  • Page 36: Logging

    [} page 43]). If the program is continued, 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: ▪...

  • Page 37: Outputting Logs Immediately And Automatically

    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 38: Subsequent Log Output

    7 Logging Graphic logs (optional) The following additional requirements must be fulfilled in order to record graphic logs: In SETUP MENU > Autom. logging > Graphic logs at least one output medium is set to YES. At least one of the output media selected for graphic logs corresponds to an output medium for the text log.

  • Page 39: Deleting The Saved Logs

    7 Logging Press repeatedly to select an output medium. Should you wish to accept the settings from Autom. logging menu, select the option automatic. Press to navigate to the Log type option. Press to chose between the log types, e.g. Last log, Logs of day etc. Press to start log output.
  • Page 40 : V1.310 18.09.2017 Proof of authenticity: must never ---------------------------------------- be changed; permits inference that the data was created on a MELAG device and has not been changed Sensor measurement values are displayed in the case of a malfunction. The values are...
  • Page 41 7 Logging Step Start End Duration °C ml mbar --> Disinfection --> Process start D1E02 36:29 36:29 0:00 23.0 ---- --- 31 Emptying02 S1X01 0:00 0:00 0:00 25.5 ---- --- 01 Start01 D1P01 36:29 36:33 0:04 23.1 ---- --- 32 Pause01 -->...

  • Page 42: Finding The Logs

    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.

  • Page 43: Settings

    8 Settings 8 Settings SETUP MENU The SETUP MENU contains the settings for the date, time and display contrast. Navigate in the SETUP MENU as follows: Press to navigate SETUP MENU in the main menu. Press to open the SETUP MENU. Press to leave the SETUP MENU.

  • Page 44: Setting Date And Time

    8 Settings Working in the SETUP MENU [} page 43] set the output medium as follows: Press to navigate to Autom. logging. Press to open the Autom. logging menu. Ê The selectable output media are displayed consecutively. Press to navigate in the SETUP MENU to CF card YES. Ê...

  • Page 45: Setting The Display Contrast

    8 Settings Press to change the month. Proceed in a similar fashion here. Press to leave the SETUP MENU. Ê The value selected will be saved automatically upon leaving the SETUP MENU. Setting the time Working in the SETUP MENU [} page 43] set the time as follows: Press repeatedly to navigate to Time.

  • Page 46: Selecting The Language

    The value selected will be saved automatically upon leaving the SETUP MENU. Other languages can also be installed. To this end, the corresponding language update file must be down- loaded on the device from the CF card. Please consult your MELAG customer services or stockist for this. Setting the water hardness...

  • Page 47: Function Tests

    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.

  • Page 48: Maintenance

    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.
  • Page 49 10 Maintenance Inspect the coarse and the fine sieves for soiling. Rinse the soiled sieve under running water. Do not use any dish-washing detergent. Remove any deposits with a soft brush. Check the rinse arm Soiling can block the nozzles of the rinse arms. Check both rinse arms regularly and rinse the nozzles if necessary.

  • Page 50: Cleaning On Demand

    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.

  • Page 51: Changing The Filter In The Drying Fan

    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 52: Maintenance

    ▪ 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 validation. ▪ The validator and technical service can download a "Recommendation for validating the...

  • Page 53: Pause Times

    ▪ 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.

  • Page 54: Transport Within The Practice

    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.

  • Page 55: Malfunctions

    12 Malfunctions 12 Malfunctions Not all notifications on the display are malfunction messages. Warnings and malfunction messages are issued on the display with an event number. This number serves identification purposes. Warnings are marked with a W and malfunction messages with an F. Follow all the instructions relating to a warning or malfunction message issued by the device display.

  • Page 56: General Events

    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 57: Warnings

    Format the CF card in the device. The CF card memory is too large (max. Insert a CF card with a memory of up to 4 GB). 4 GB. The MELAG logo must point rightwards during insertion. MELAG recommends using original accessories only.
  • Page 58 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 only.
  • Page 59 The device is not connected to a com- puter, but the option computer has been activated in the SETUP MENU. The MELAG device is not connected to a Working on the display, select SETUP computer, but the option computer is active MENU > Autom.
  • Page 60 Setting date and time [} page 44]. 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.
  • Page 61 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 keys indicated in the display to unlocked immediately. acknowledge the notification. The door can be opened.

  • Page 62: Malfunction Messages

    12 Malfunctions Malfunction messages Event Possible cause Remedy The cleaning agent metering pump is not Switch the device off and then on again. functioning correctly. The metering system Start the program again. may be blocked. The fan of the display is not functioning Switch the device off and then on again.
  • Page 63 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.
  • Page 64 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 air is being transported. NOTICE! Use only process agents which you have used before.
  • Page 65 Remove and replace the soiled filter disc. filter disc in the universal adapter for Clean the reusable filter screen. transmission instruments. Strong foam generation: non-approved NOTICE! Use only MELAG-approved process process agents (rinse aid or cleaning agent) agents. have been used. The temperature difference between the two...
  • Page 66 Strong foam generation: strong soiling of the Remove and replace the soiled filter disc. filter disc in the universal adapter for Clean the reusable filter screen. transmission instruments. Strong foam generation: non-approved NOTICE! Use only MELAG-approved process process agents have been used. agents.
  • Page 67 12 Malfunctions Event Possible cause Remedy The salt store has been exhausted. No further Fill regenerating salt, see Filling the regeneration can be performed. regeneration salt [} page 21]. A program can be started if the salt has dissolved in the water. Do not start the program until the regenerating salt has been filled and the signal tone has sounded.
  • Page 68 The instruments are pre-cleaned or placed in a foam-generating solution. Non-approved process agents (incorrect rinse Use only MELAG-approved process agents. aid or cleaning agent) have been used. The metering concentration has been set Check the settings of the metering incorrectly.
  • Page 69 12 Malfunctions Event Possible cause Remedy The water inflow was interrupted during the Open the water inflow tap completely. active program. Start the program again. The water inflow must be secured during the entire duration of the active program. The power supply for the DTA device version Check whether the power plug has been is insufficient.

  • Page 70: Technical Data

    13 Technical data 13 Technical data Device dimensions MELAtherm 10 DTA/DTB Device type Under-desk unit Free standing Cabinet device Device dimensions 81.8 x 59.8 x 67.8 cm 83.6 x 59.8 x 67.8 cm 124 x 59.8 x 67.8 cm (H x W x D)
  • Page 71 13 Technical data Device type MELAtherm 10 DTA MELAtherm 10 DTB Wastewater Wastewater connection DN21 Max wastewater temperature 93 °C (< 1 min, approx. 5.5 l) Amount of wastewater per hour ca. 30 l (in small intervals) Capacity of drain pump max.

  • Page 72: Accessories

    14 Accessories 14 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 Art. no. Optionally available Floor unit (H x W x D) 40 cm x 59.8 cm x 59.8 cm...

  • Page 73: Documentation And Approval

    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...

  • Page 74: Glossary

    Authorized technician The term “authorized technician” refers to an em- ployee of a customer service provider or stockist who has been trained and authorized by MELAG to perform maintenance and installation work on MELAG devices. Only they may carry out this work.
  • Page 76 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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