MELAG MELAseal 200 Operating Manual
Bar sealer
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Operating Manual
Operating Manual
®
MELAseal
200
Bar sealer
Software version 1.12
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 sealing device.
Since 1951 MELAG, a medium-sized family-run enterprise, has specialised in the sector of hygiene for medical practices.
In the meantime our company has grown into one of the world's leading producers of sterilization equipment. World sales
of more than 450,000 MELAG devices give testimony to the quality of our products, which we manufacture exclusively in
Germany.
This device was manufactured and checked according to strict quality criteria.
MELAG – management and employees
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Table of Contents
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Summary of Contents for MELAG MELAseal 200
- Page 1 Since 1951 MELAG, a medium-sized family-run enterprise, has specialised in the sector of hygiene for medical practices. In the meantime our company has grown into one of the world's leading producers of sterilization equipment. World sales of more than 450,000 MELAG devices give testimony to the quality of our products, which we manufacture exclusively in Germany.
- Page 2 General notes Please read this operating manual carefully before commissioning the sealing device. The functionality and value- retention of this sealing device depends on the care accorded to it. The instructions include important safety information. Please read the safety information carefully before using the sealing device.
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Page 3: Table Of Contents
Table of contents Table of contents Chapter 1 – Performance Specifications ..5 DIN Specifications ........30 Intended Use ............... 5 Terms ................. 30 General information regarding the packaging and Chapter 2 – Device description ....... 6 sealing procedure............30 Scope of delivery ............ - Page 4 Never open the housing of the sealing device. Incorrect opening and repair can compromise electrical safety and pose a danger to the user. The guarantee and warranty are forfeited as soon as the sealing device is opened by anyone other than a member of a MELAG-authorized technical customer service.
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Page 5: Chapter 1 - Performance Specifications
It is suitable for the heat sealing of instruments in transparent sterilization packaging in accordance with DIN EN 868-5 e.g. MELAfol. Should you wish to use any other packaging materials as those named above, please consult your stockist first or contact MELAG directly. Unsuitable film and materials ... -
Page 6: Chapter 2 - Device Description
Chapter 2 – Device description Scope of delivery Please check the scope of delivery before setting up and connecting the sealing device. Standard scope of delivery 1x MELAseal 200 bar sealer 1x power cable 1x lever ... -
Page 7: Status Display And Acoustic Signals
Switch off the sealing device and then back is taking too long (> 5 min.); the on again. LED illuminates red, sealing device cannot reach the Warn signal sounds pre-set sealing temperature. Upon repeated occurrence, inform your stockist / MELAG customer services. (malfunction) -
Page 8: Chapter 3 - Commissioning
Chapter 3 – Commissioning Chapter 3 – Commissioning Transport and storage WARNING The use of unsuitable packaging can result in damage to the housing and the device interior. The sealing device should only be transported in its original or otherwise suitable packaging. Storage The device should be stored in such a way to protect against humidity. -
Page 9: Commissioning
Chapter 3 – Commissioning Commissioning Connecting the sealing device Check the following points before connecting: The device power switch is on. Use only the network cable included in the scope of delivery. The USB flash drive included in the scope of delivery is plugged into the sealing device. Connect the low-heat power socket of the power cable to the rear side of the sealing device and connect the power plug in the power socket. -
Page 10: Simple Sealing Procedure
Chapter 3 – Commissioning Simple sealing procedure DANGER The sealing bar is heated continuously after the sealing device has been switched on. The surrounding metal components are hot! Contact with the hot metal parts can result in burns. Never touch the metal surfaces on the cutting bar or in the area of the rear and fore paper guide directly. -
Page 11: Sealing Procedure For Roll Stock
Chapter 3 – Commissioning Open The sealing procedure has been completed successfully. If the USB flash drive has been connected, a log will automatically be generated and saved on the USB flash drive. If a USB flash drive has not been connected, the most important sealing parameters will be displayed alternately up to 4 times. - Page 12 Chapter 3 – Commissioning Leave the lever depressed as long as the progress bar in the display completes (for 3 seconds). Ideally, the film should be cut off during the sealing procedure. Move the knife to the other end of the sealing device quickly;...
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Page 13: Seal Seam Width
Chapter 3 – Commissioning WARNING The film side of the packaging must always face upwards. Should the packaging be inserted incorrectly, this could result in the deposit of film residue on the sealing rail. Press the lever forwards to its fullest extent until it clicks. Leave the lever depressed as long as the progress bar in the display completes (for approx. -
Page 14: Chapter 4 - Settings
Chapter 4 – Settings Chapter 4 – Settings Menu structure ├ Standard display output Key: │ └ Display of temperature/time/ready ├ User User │ ├ User 01 User 01 │ ├ User 02 User 02 │ ├ … … │ └ User 10 User 10 ├... -
Page 15: Changing The Sealing Temperature
Chapter 4 – Settings Press to save the settings. The minute display will now flash. Press to change the minutes forwards or backwards. Press to save the settings. The display no longer flashes. repeatedly to leave the menu (press three times start display). Press Date NOTE... -
Page 16: Switching The Signal Tones On And Off
The display returns to the initial state. We recommend that you draw up an overview in your QM documents from which you can find the allocation of each user in MELAseal 200. Example: ® The name of the trained... -
Page 17: Eco Mode And Standby
Chapter 4 – Settings Eco Mode and Standby The MELAseal 200 is equipped with a two-stage energy-saving function. Eco mode: If the lever or keys are not activated within 15 minutes after the sealing device has been activated (Ready Mode), Eco Mode will be activated, i.e. the temperature will be reduced by 40°C. -
Page 18: Chapter 5 - Logging
Chapter 5 – Logging Chapter 5 – Logging DIN EN ISO 11607-2 requires that the sealing process be monitored and documented in order to satisfy the requirement for compliance with the specifications contained in part 2 of the standard. As a result, you are able to record the logs of the seal runs and output and archive them on the following output media: ... -
Page 19: Using The Computer As An Output Medium
The sealing device is connected to the computer via a USB cable (art.-no. 19902, optionally available). Proceed as follows to connect the sealing device to a computer: Install the MELAseal 200 PC driver on your computer. The driver can be downloaded from the download centre on the MELAG Website (www.melag.de/service/download-center/pc- anwendungen/MELAview). -
Page 20: Reading Logs Correctly
The corresponding fault value (e.g. sealing temperature, or force) will, depending on the nature of the fault, be displayed in square brackets or no value will be displayed. Example of a log of multiple sealing procedures -------------------- MELAG MEDIZINTECHNIK -------------------- 10 MELAG MELAseal 200 15 Date: 2014-08-14 20 S/N: 132000901 25 Ver: V1.12... -
Page 21: Chapter 6 - Optional Accessories
Chapter 6 – Optional Accessories Chapter 6 – Optional Accessories Roll dispenser “standard” The roll dispenser "standard“ is placed directly behind the sealing device. The rolls of film are placed into the cavity and held in position using additional spacers located to the left and right. This prevents them from slipping. -
Page 22: Wall-Mounted Roll Dispenser
Chapter 6 – Optional Accessories The roll dispensers “komfort“ and "deluxe" are hooked onto the mounts on the rear of the sealing device. Roll dispenser "comfort" (Detail view of rear side) Wall-mounted roll dispenser Mounted on the wall directly over the sealing device, the wall- mounted roll dispenser saves space. -
Page 23: Chapter 7 - Maintenance
Chapter 7 – Maintenance Chapter 7 – Maintenance Pause times The sealing device can remained switched on over longer operating pauses of many hours. The sealing device automatically switches into Eco Mode (= energy-saving mode) after only 15 minutes and then into standby after a further 15 minutes. See Chapter 4 –... -
Page 24: Cleaning And Regular Controls
Arrange for servicing in two year intervals or after every 50,000 sealing procedures. Validation Your MELAseal 200 sealing device complies with all standard requirements for the validation of the sealing process in accordance with DIN EN ISO 11607-2. Conformity is confirmed with the declaration of conformity included in the scope of delivery. - Page 25 Chapter 7 – Maintenance Press to complete the procedure. The display changes to MELASEAL. Switch off the sealing device and remove the USB flash-drive. Delete the update file from the USB flash drive. Otherwise, an update will be requested after every activation.
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Page 26: Chapter 8 - Malfunctions
To avoid the risk of electrical shocks, never open the housing of the sealing device. The device may only be serviced by a technician authorized by the MELAG customer services. PLEASE NOTICE The warning and fault messages are generally confirmed with... - Page 27 Upon repeated occurrence, inform your stockist/MELAG customer services. Err_07/Tmp_Sens Temperature sensor defective. Switch the sealing device off and then on again. If this is unsuccessful, inform MELAG customer services/your stockist Err_08/Temp_PCB Sealing device overheated, Operate the sealing device only within the ambient temperature too high.
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Page 28: Manufacturer's Recommendation For Routine Operation
Check for dryness and integrity once again, before using the instruments. Weekly Checking the seal Perform a visual control using MELAG seal check and seam with aids document the results - for criteria and further information, see the MELAG seal check operation manual... - Page 29 Manufacturer's Recommendation for Routine Operation MELAG seal seam strength test For validating your sealing processes MELAG provides a seal seam stability test for a cost price of 125.00 € plus V.A.T. (state 01/2015) After the film test strips have been tested, MELAG will issue verification of testing and if successful, a certificate.
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Page 30: Din Specifications
DIN Specifications DIN Specifications Terms Sterile barrier system DIN EN ISO 11607-2:2006 replaces the terms "packaging" "end packaging" and primary packaging" with the single term "sterile barrier system." A sterile barrier system is the minimum level of packaging facilitating successful sterilization, serving as a micro-biological barrier and permitting aseptic provision. -
Page 31: Storage Length For Sterile Medical Products
DIN Specifications Storage length for sterile medical products Guidelines for the storage period of sterile medical products according to DIN 58953- 8:2010: This standard applies to the delivery, storage, commissioning, transport and provision (including the packaging and marking necessary for these ends) of all sterile medical products to be used in healthcare institutions such as hospitals, dental and medical practices. -
Page 32: Accessories And Spare Parts
Spacer washers (1x) for roll dispenser "deluxe" 88110 Distance plate (2x) for roll dispenser „standard“ 72335 MELAG seal check 01079 MELAG USB flash drive (8 GB) for documentation 19901 USB cable, 1.8 m 19902 MELAtrace/MELAview documentation software 21127 Spare Parts... - Page 34 MELAG Medizintechnik oHG Geneststraße 6-10 10829 Berlin Germany E-Mail: info@melag.de Web: www.melag.de Responsible for content: Technical Office Subject to technical alterations Your stockist:...
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