MELAG MELAseal 200 User Manual
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MELAG MELAseal 200 User Manual

Sealing device
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User Manual
MELAseal
Sealing device
from software version 2.28
EN
Dear customer,
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 reprocessing and hygiene field.
You, our customer are justified in your demand for the best products, quality and reliability. Providing
hygiene"
and
"Quality – made in
agement system is subject to close monitoring: one instrument to this end is our annual multi-day audit conducted in ac-
cordance with EN ISO 13485. This guarantees that all MELAG products are manufactured and tested in accordance with
strict quality criteria.
The MELAG management and team.
®
200
Germany", we guarantee that these demands will be met. Our certified quality man-
"competence in

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Summary of Contents for MELAG MELAseal 200

  • Page 1 2.28 Dear customer, 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 Description of the device.............................. 7 Intended use .................................. 7 Scope of delivery ................................. 7 Views of the device................................ 8 Symbols on the device................................. 9 Menu structure................................... 10 Status display and acoustic signals ........................... 11 4 Commissioning................................... 12 Requirements of the installation location ........................... 12 Space requirements................................ 12...
  • Page 4 Reel dispenser Deluxe............................... 32 Wall mounted reel dispenser ............................. 32 12 Malfunctions .................................. 33 13 Manufacturer's recommendation for routine operation .................... 36 Performing the peel test.............................. 36 MELAG seal seam stability test ............................ 36 14 Standard specifications .............................. 37 15 Technical Data .................................. 38 16 Accessories and spare parts ............................ 39...

  • Page 5: General Guidelines

    Make sure that you always have access to digital or printed version of the user manual. Should the manual no longer be legible, is damaged or has been lost, you can download a new copy from MELAG down- load centre at www.melag.com.

  • Page 6: Safety

    Never open the device housing. 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 device is opened by anyone other than a MELAG- authorised technician.

  • Page 7: Description Of The Device

    German standard DIN  58953-7. The bar sealing device MELAseal 200 is not a medical device as defined by the Medical Device Regulation. Suitable materials For the heat sealing of transparent sterilization packages in accordance with EN 868-5 e.g. MELAfol reels and pouches are suitable.

  • Page 8: Views Of The Device

    3 Description of the device Views of the device View from front 1 Knife handle 2 Display with control lamp View from rear 3 Bracket for reel dispenser 4 Power cable connection 5 USB interface (type B) for connection to the computer View from left 6 USB interface for the USB flash drive...

  • Page 9: Symbols On The Device

    3 Description of the device View from right 8 Power switch (On/Off) 9 Sealing lever 10 Operating keys Symbols on the device Type plate Manufacturer of the product Date of manufacture of the product Article number of the product Serial number of the product Observe user manual or electronic user manual Do not dispose of product in household waste CE marking...

  • Page 10: Menu Structure

    3 Description of the device Menu structure ├ Standard display output │ └ 180°C/User 1/Ready Temperature/User/Operational readiness ├ User User │ ├ User 01 User 01 │ ├ User 02 User 02 ├ ├ User... User... │ └ User 10 User 10 ├...

  • Page 11: Status Display And Acoustic Signals

    3 Description of the device Status display and acoustic signals Control lamp/acoustic Possible cause What you can do signal The sealing device is in the heating or Wait until the pre-set sealing temperature has cooling phase. been reached. LED illuminates orange The sealing lever is depressed during Acknowledge the message with and wait...

  • Page 12: Commissioning

    Ensure that the sealing device is located away from direct sunshine and outside the range of other sources of heat. Set-up the device protected against blows or vibrations. Space requirements View from the front and right Device dimensions MELAseal 200 Width 36.5 cm Width including sealing lever 41.5 cm...

  • Page 13: Connecting The Sealing Device

    4 Commissioning Connecting the sealing device ü The sealing device has been switched off. ü The power cable, delivered in the scope of delivery, is present. Connect the IEC plug of the power cable to the rear side of the sealing device and connect the power plug in the power socket.

  • Page 14: Sealing

    5 Sealing 5 Sealing Video tutorial See also “Wrapping Instruments”. Sealing procedure with pre-finished film pouches CAUTION Danger of burns from hot metal parts. The sealing rail is heated continuously when the sealing device is switched on. Never touch the metal surfaces on the sealing rail or in the area of the rear and fore paper guide. NOTICE Inserting the packaging inverted can result in the adhesion of film residue to the sealing rail.

  • Page 15: Sealing Procedure For Film Reels

    5 Sealing Leave the sealing lever depressed as long as the progress bar in the display completes and the control lamp flashes green at short intervals (approx. 3 s). When the display switches to Open and the control lamp is continuously illuminated green, raise the sealing lever to its starting position.
  • Page 16 5 Sealing Leave the sealing lever depressed as long as the progress bar in the display completes and the control lamp flashes green at short intervals (approx. 3 s). Cut of the film roll during the sealing procedure. Leave the sealing lever depressed and move the handle of the knife to the other end of the sealing device quickly.
  • Page 17 5 Sealing Press the sealing lever down until it latches. Leave the sealing lever depressed as long as the progress bar in the display completes and the control lamp flashes green at short intervals (approx. 3 s). When the display switches to Open and the control lamp is continuously illuminated green, raise the sealing lever to its starting position.

  • Page 18: Logging

    6 Logging 6 Logging Documenting the sealing process Video tutorial See also “Documentation and User Administration”. EN ISO 11607-2 requires that the sealing process is 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 sealing procedures, to output and archive them on the following output media: ▪...

  • Page 19: Computer As Output Medium

    ü Firmware 2.10 and above requires MELAview Docu/MELAtrace from version 3.6.2.1. Install the MELAseal 200 PC driver on your computer. Download the driver from the MELAG website (Service/Download Center). Connect the type B USB cable to the rear panel of the sealing device and connect the other end to the computer.
  • Page 20 6 Logging Example of a log with several sealing procedures: Key: Row 10 - Designation of the sealing device Row 15 - Date of sealing procedure Row 20 - Serial number of the sealing device Row 25 - Software version installed Row 30 - Total operating hours Row 35...

  • Page 21: Function Checks

    7 Function checks Function check with MELAcontrol Seal Check The MELAcontrol Seal Check serves to check the function of the seal seam produced by your sealing device. MELAG recommends performing this function check once a day during operation. The device is fitted with a reminder function which reminds e.g. at the daily seal check. Alternatively the seal check can be performed manually.
  • Page 22 7 Function checks Confirm the display with the key Ê The display changes to Seal chk and flashes. Prepare the MELAcontrol Seal Check test strip with the transparent sterilization package in accordance with the applicable instructions for use and perform a test seal. Ê...

  • Page 23: Settings

    8 Settings 8 Settings Access settings menu Proceed as follows to reach the settings menu and the desired submenu: Switch on the sealing device and wait until the temperature is displayed. Press repeatedly in order to navigate to Settings. Press to navigate to the Settings menu.

  • Page 24: Date

    The sealing temperature is determined by the type of sterilization packaging. The sealing temperature for MELAfol reels and pouches is 170-190 °C. MELAG recommends a sealing temperature of 180 °C. When using MELAfol transparent sterilization package retain the works setting sealing temperature of 180 °C. When using sterilization packages from oth- er manufacturers, comply with their specifications.

  • Page 25: Signal Tones

    Ê The display returns to the initial state. PLEASE NOTE MELAG recommends drawing up an overview in your QM documents from which you can find the allocation of each user for the sealing device. Example of a user overview Name of the instructed employee...

  • Page 26: Eco Mode And Standby

    8 Settings Eco Mode and Standby Video tutorial See also “Sealing Temperature and Eco Mode”. The sealing device is equipped with a two-stage energy-saving function. 1. Waiting time: Eco Mode If with a sealing device ready for operation (Ready mode) the sealing lever or keys are not activated within a certain time, the Eco Mode will be activated.

  • Page 27: Force Calibration

    8 Settings Switching off Eco mode and Standby PLEASE NOTE Eco mode and Standby are always switched off together. It is not possible to switch off Eco mode or Standby separately. Proceed as follows to switch off Eco mode and Standby: ü...

  • Page 28: Maintenance

    Continuing operation beyond the maintenance interval can result in malfunctions in the device! Maintenance should only be performed by trained and authorised technicians. Maintain the specified maintenance intervals. Carry out maintenance with an original maintenance set prepared by MELAG. Only original MELAG spare parts may be used. Validation Your sealing device complies with all standard requirements for the validation of the sealing procedure in accordance with EN ISO 11607-2.
  • Page 29 9 Maintenance Press to complete the procedure. Ê 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. Ê...

  • Page 30: Pause Times

    10 Pause times 10 Pause times Pause times The sealing device can remain switched on over longer operating pauses of many hours. The sealing device switches into Eco mode (= energy-saving mode) after a user-defined time and then into standby following a further waiting time, Eco Mode and Standby [} page 26].

  • Page 31: Optional Accessories

    11 Optional accessories 11 Optional accessories Reel dispenser Standard The reel dispenser Standard is placed directly behind the sealing device. The film reels are placed into the cavity and held in position using additional spacers located to the left and right. This prevents them from slipping.

  • Page 32: Reel Dispenser Deluxe

    11 Optional accessories Reel dispenser Deluxe When using the reel dispenser Deluxe, the film reels are stored above the sealing device, thus saving space. The integrated feeding device enables easy feeding of the film via a hand wheel. Further information regarding assembly and operation is specified in the appendent user manual.

  • Page 33: Malfunctions

    12 Malfunctions Troubleshooting online All messages with current descriptions can be found in the Troubleshooting portal on the MELAG website (https://www.melag.com/en/service/troubleshooting). WARNING Improper opening of the housing cover brings the danger of an electric shock. Never open the sealing device housing cover without authorisation.
  • Page 34 Rename the USB flash drive on the computer. If necessary, replace the USB flash drive. MELAG recommends the use of a MELAG USB flash drive. There is no connection between the Working in the device manager of your computer, sealing device and the computer.
  • Page 35 USB flash drive. The maximum time or number of sealing Check the date in the log header If the date is procedures has been reached. Perform correct, then arrange for a MELAG authorised maintenance of the sealing device technician to perform maintenance.

  • Page 36: Manufacturer's Recommendation For Routine Operation

    MELAG offers a seal seam stability test for the validation of your sealing processes. After testing the film test strips, you will receive a certificate from MELAG stating the conformity of the seal seams with the EN 868-5 standard, Appendix D, if the seal seam stability test is successful.

  • Page 37: Standard Specifications

    Maintain the clearance between seal seam and cutting edge as prescribed in the standard: DIN 58953-7 requires the maintenance of a sufficient overhang between the seal seam and the cutting edge when working with film pouches on the removal side. This ensures aseptic removal. MELAG recommends a minimum overhang of 10 mm.

  • Page 38: Technical Data

    15 Technical Data 15 Technical Data Device type MELAseal 200 Device dimensions (W x D x H) 41.5 x 24 x 15 cm Weight 5.4 kg Electrical connection Power supply 200-240 V, 50/60 Hz Electrical power max. 300 W, average 100 W...

  • Page 39: Accessories And Spare Parts

    ME13330 Spacer washer reel dispenser Comfort/Deluxe (white) ME89740 Separating plate for reel dispenser Standard (2 pcs.) ME72335 Calibration box for MELAseal 200 (without thermometer and scale) ME10121 Suspension scale with calibration certificate ME87500 Thermometer with sensor and calibration certificate ME87580...
  • Page 40 MELAG Medizintechnik GmbH & Co. KG Geneststraße 6-10 10829 Berlin Germany Email: info@melag.com Web: www.melag.com Original instructions Responsible for content: MELAG Medizintechnik GmbH & Co. KG We reserve the right to technical alterations Your stockist...

This manual is also suitable for:

Melaseal 100+

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