MELAG MELAseal 100+ User Manual

MELAG MELAseal 100+ User Manual

Sealing device
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User Manual
MELAseal
Sealing device
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 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
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.
®
100+
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 100+

  • Page 1 Sealing device 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

    Roll dispenser “comfort” .............................. 17 Roll dispenser “Deluxe”.............................. 18 Wall-mounted roll dispenser............................... 18 9 Manufacturer's recommendation for routine operation .................... 19 Performing the peel test .............................. 20 MELAG seal seam stability test ............................ 20 10 Standard specifications .............................. 21 11 Technical Data .................................. 23 12 Accessories and spare parts ............................ 24...
  • Page 4: General Guidelines

    Store this user manual carefully and in close proximity to your device. It represents a component of the product. Should the user manual no longer be legible, damaged or lost, obtain a new copy from MELAG. State the device type and your address in an e-mail.
  • Page 5: 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-authorized technician.
  • Page 6: Description Of The Device

    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, please consult your stockist or contact MELAG directly. Unsuitable materials Sterilization packaging that is not compatible with the requirements of DIN EN 868-5, is incompatible with this device: ▪...
  • Page 7: Views Of The Device

    3 Description of the device Views of the device View from front Knife handle Control lamp View from rear Brackets for roll dispenser left Brackets for roll dispenser right Power cable connection View from the left Rotary knob for temperature setting Square hole for sealing lever (on both sides)
  • Page 8: Symbols On The Device

    3 Description of the device View from the right Sealing lever Power switch (On/Off) Symbols on the device Manufacturer of the product Date of manufacture of the product Product serial number from the manufacturer Article number of the product Electrical connection of the device: AC current The user manual includes important safety information.
  • Page 9: Status Display And Acoustic Signal

    3 Description of the device Status display and acoustic signal Control lamp / Possible cause Measure acoustic signals LED illuminates The sealing device is in the heating or Wait until the pre-set sealing orange cooling phase. temperature has been reached. LED flashes red, ▪...
  • Page 10: Commissioning

    4 Commissioning 4 Commissioning Requirements of the installation location CAUTION Failure to comply with the set-up conditions can result in injuries, malfunctions and/or damage to the device. Comply with all the specifications of this chapter for initial commissioning. The device is not suitable for operation in explosive atmospheres. The device is only intended for use in interior spaces.
  • Page 11: Connecting The Sealing Device

    4 Commissioning Connecting the sealing device ü The sealing device has been switched off. ü Use the power cable included in the scope of delivery. Connect the rubber connector of the power cable to the rear side of the sealing device and connect the power plug in the mains socket.
  • Page 12: Sealing

    The sealing temperature is determined by the type of sterilization packaging. When using MELAfol transparent sterilization packaging as provided by MELAG, turn the rotary knob to point to the middle of the area marked with “MELAfol” (corresponds to 180 °C).
  • Page 13: Sealing Procedure For Film Rolls

    5 Sealing Press the sealing lever down until it latches. Leave the sealing lever depressed until the control lamp flashes green in short intervals (approx. 4 s). When the control lamp is continuously illuminated green again, return the sealing lever upwards to its starting position.
  • Page 14 5 Sealing Ideally, the film should be cut off during the sealing procedure: Move the knife handle to the other end of the sealing device quickly; the sealing lever should remain depressed. Do not return the knife handle. As soon as the LED control lamp is continuously illuminated green, raise the sealing lever and remove the film bag thus produced.
  • Page 15: Maintenance

    6 Maintenance 6 Maintenance Cleaning and regular controls Comply with the following information when cleaning: Switch off the sealing device at the power switch and remove the power plug before cleaning. The cleaning cloth may never be allowed to become entirely wet in order to prevent water from entering the interior of the sealing device.
  • Page 16: Pause Times

    7 Pause times 7 Pause times Pause times The sealing device can remain switched on over longer operating pauses of many hours. MELAG recom- mends switching off the device during long operating pauses to save energy. Transport and storage NOTICE Damage to the housing and the device interior as a result of using unsuitable transport packaging.
  • Page 17: Optional Accessories

    8 Optional accessories 8 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. Hook the roll dispenser “standard”...
  • Page 18: Roll Dispenser "Deluxe

    8 Optional accessories Roll dispenser “Deluxe” In the roll dispenser “Deluxe”, the rolls of film 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 operating manual.
  • Page 19: Manufacturer's Recommendation For Routine Operation

    ▪ Check for dryness and integrity once again, before using the instruments. Weekly Check the seal seam with Perform a visual control using MELAG Seal Check resources and document the results (e.g. using the MELAconnect app) – for criteria and further information, see the MELAG Seal Check operating manual.
  • Page 20: Performing The Peel Test

    Document the results. MELAG seal seam stability 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 01/2020). After the film test strips have been tested successfully, MELAG will issue a certificate.
  • Page 21: 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 transparent bags on the removal side. This ensures aseptic removal. MELAG recommends a minimum overhang of 10 mm.
  • Page 22 10 Standard specifications Guidelines for the storage duration of sterile medical devices in accordance with DIN 58953-8 This standard applies to the delivery, storage, commissioning, transport and provision (including the pack- aging and labelling of sterile medical devices to be used in healthcare institutions such as hospitals and dental and medical practices).
  • Page 23: Technical Data

    11 Technical Data 11 Technical Data Device type MELAseal 100+ Device dimensions (W x D x H) 41.5 x 24 x 15 cm Weight 5.4 kg Electrical connection Power supply 220-240 V, 50/60 Hz | 100-110 V, 50/60 Hz Electrical power max.
  • Page 24: Accessories And Spare Parts

    Spacer washer (1 pcs.) for wall-mounted roll dispenser 13330 Spacer washer (1 pcs.) for roll dispenser “Deluxe” and “comfort” 89740 Distance plate for roll dispenser “standard” (2 pcs.) 72335 MELAG Seal Check 01079 MELAink Test 01089 Spare parts Lever, black (sealing lever)
  • Page 26 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...

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