MELAG MELAseal 100+ Operating Manual
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MELAG MELAseal 100+ Operating Manual

MELAG MELAseal 100+ Operating Manual

Sealing device
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Operating Manual
MELAseal
Sealing device
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
agement system is subject to close monitoring: one instrument to this end is our annual multi-day audit conducted in ac-
cordance with 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 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

    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 DIN Specifications ................................ 21 11 Technical Data .................................. 23 12 Accessories and spare parts ............................ 24...

  • Page 4: General Guidelines

    Reference to another text section within this document MELAconnect App The MELAconnect app provides the following functions for MELAG sealing devices integrated in your practice network from any location in the practice. ▪ Access to user manuals and video tutorials for using the device.

  • 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 sealing 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 Knife handle Control lamp Fig. 1: Front view Bracket for roll dispenser (left) Bracket for roll dispenser (right) Socket for power cable Fig. 2: View from rear Rotary knob for temperature adjustment Square hole for lever (on both sides) Fig. 3: Fore left view Lever...

  • Page 8: Symbols On The Device

    Device fault: The heating phase is taking Upon repeated occurrence, too long (> 5 min); the sealing device does inform your stockist/MELAG not reach the pre-set sealing temperature. customer services. PLEASE NOTE If further status displays or acoustic signals occur, contact the MELAG customer service/ service technician.

  • Page 9: 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 10: Connecting The Sealing Device

    4 Commissioning Connecting the sealing device Check the following points before connecting: ü The sealing device has been switched off. ü Use only the power cable included in the scope of delivery. Connect the one end of the power cable with the port on the rear of the sealing device and the other end with a mains socket with an approved voltage supply.

  • Page 11: 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 12: Sealing Procedure For Film Rolls

    5 Sealing Press the lever forwards to its fullest extent until it snaps. Leave the lever depressed as long as the control lamp flashes green in short intervals (for approx. four seconds). When the control lamp is continually illuminated green again, return the lever upwards to its starting position.
  • Page 13 5 Sealing Ideally, the film should be cut off during the sealing procedure: Move the knife to the other end of the sealing device quickly; the lever should remain depressed. Do not return the knife handle. As soon as the control lamp is continuously illuminated green, raise the lever and remove the film bag thus produced.
  • Page 14 5 Sealing When the control lamp is continually illuminated green again, return the lever upwards to its starting position. Perform a visual inspection of the film after every successful sealing procedure. Ê The sealing procedure has been completed successfully.

  • Page 15: Maintenance

    6 Maintenance 6 Maintenance Cleaning and regular controls Frequency Action Every 6 months Clean the exterior of the sealing device with a dry or damp, non-fuzzing cloth and a stainless steel-cleaning agent suitable for use with medical devices. It should not deposit any oily residue.

  • Page 16: Pause Times

    7 Pause times 7 Pause times Pause times The sealing device can remained switched on over longer operating pauses of many hours. We re- commend that the device remain switched off during long operating pauses so as to save energy. Transport and storage NOTICE Damage to the housing and the device interior as a result of using unsuitable transport...

  • 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 Checking the seal seam Perform a visual check using MELAG seal check with resources and document the results (e.g. with the MELAconnect App) - for criteria and further information, see the MELAG seal check operation 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 01/2019). After the film test strips have been tested successfully, MELAG will issue a certificate.

  • Page 21: Din Specifications

    10 DIN Specifications 10 DIN Specifications Explanation of terms Term Explanation Sterile barrier system DIN EN ISO 11607-2 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 which prevents the penetration of micro-organisms and permits aseptic provision of the product at the location of use.
  • Page 22 10 DIN Specifications which are to be handled in such a manner so as that their quality is maintained until coming to aseptic ap- plication. According to DIN 58953-8 section 7.1.1, responsibility for compliance with the specified storage requirements and period lies with the operator of the institution. According to section 7.2, loss of sterility is dependent less on the length of the storage time as from external influences during storage, as well as transport and handling.

  • 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 Electrical connection 220-240 V, 50/60 Hz | 100-110 V, 50/60 Hz Electrical power max.

  • Page 24: Accessories And Spare Parts

    00106 Spacer washer (x1) for wall-mounted roll dispenser 13330 Spacer washer (x1) 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 77000...
  • Page 26 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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