MELAG MELAseal Pro Operating Manual
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MELAG MELAseal Pro Operating Manual

Rotary sealer
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Operating Manual
®
MELAseal Pro
Rotary sealer
Software version 1.02.02
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 "competence in
hygiene" and "Quality – made in Germany", we guarantee that these demands will be met. Our certified quality
management system is subject to close monitoring: one instrument to this end is our annual multi-day audit conducted in
accordance with ISO 13485 and ISO 9001. This guarantees that all MELAG products are manufactured and tested in
accordance with strict quality criteria.
The MELAG management and team

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Summary of Contents for MELAG MELAseal Pro

  • Page 1 ISO 13485 and ISO 9001. This guarantees that all MELAG products are manufactured and tested in accordance with strict quality criteria.
  • Page 2 General notes Please read these operating instructions carefully before commissioning the sealing device. The functionality and value- retention of this sealing device depend on the care accorded to it. The instructions include important safety information. Please read all the safety instructions carefully before using the sealing device.

  • Page 3: Table Of Contents

    Table of contents Table of contents Concepts ..............22 Chapter 1 – Performance Specifications ..5 General information regarding the packaging and Intended Use ............... 5 sealing procedure............22 Seal seam width ............22 Chapter 2 – Device description ....... 6 Clearance of the seal seam to the cutting edge ..
  • Page 4 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.  The fan in the base of the sealing device must be free at all times and may not be allowed to become blocked or congested.

  • Page 5: Chapter 1 - Performance Specifications

    It was especially developed for the heat sealing of instruments in sterilization packaging and complies with the standards DIN EN ISO 11607-2 and the German DIN 58953 part 7. The MELAseal Pro rotary sealer is not a medical product as defined by the Medical Device Directive.

  • Page 6: Chapter 2 - Device Description

    Chapter 2 – Device description Chapter 2 – Device description Scope of delivery Please check scope of delivery before connecting the sealing device. Standard scope of delivery  MELAseal Pro rotary sealer  Power cable  Operating Manual Views of the device Fig.

  • Page 7: The Control Panel

    Chapter 2 – Device description The control panel Table 1: Meaning of the keys Keys Explanation Temperature setting – to increase or reduce the sealing temperature Reverse key – for removing the sterilization packaging upon a blockage of the conveyor belts. Daily batch counter –...

  • Page 8: Chapter 3 - Commissioning

    Chapter 3 – Commissioning Chapter 3 – Commissioning Transport and storage WARNING The use of unsuitable transport 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 off.  The power cable included in the scope of delivery is used for connecting. 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 10: Sealing Procedure

    ■ If it is not possible to remove the packaging by pressing the reverse key, please consult your stockist or the MELAG customer service department. WARNING! Failure to observe this provision could result in damage to or malfunction of the sealing device.

  • Page 11: Chapter 4 - Settings

    Chapter 4 – Settings Chapter 4 – Settings Changing the language To change the currently set language proceed as follows: Activate the sealing device at the power switch. Press , as soon as the display shows the current software version. Press .

  • Page 12: Changing The Sealing Temperature

    Chapter 4 – Settings Changing the sealing temperature To alter the set sealing temperature proceed as follows: Hold the two keys depressed for approx. 2 seconds until two arrows appear on the right edge of the display. Holding one of the arrows depressed initiates the temperature display. The temperature ranges from 100 °C until 199 °C.

  • Page 13: 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 14: Opening And Printing Log Files On The Computer

    Chapter 5 – Logging PLEASE NOTE The daily log is continued even if the sealing device is switched on and off once; i.e. a new daily log is not started. Opening and printing log files on the computer The log files are simple text files and can be opened with the text editor of the computer. A computer is initially not aware of the extensions of the log files.
  • Page 15 Chapter 5 – Logging Example of a log of multiple sealing procedures: -------------------- MELAG MEDIZINTECHNIK -------------------- 10 MELAG MELAseal Pro Date 06/01/2010 80 SerNr: 2009SPF0001 |Time |Charge|Tmp|Prs|Vel|Limits |CRC |--|-----|------|---|---|---|-----------------------|---- |OK|09:19| 00012|180|098|087|185-175 120-090 120-078|F228(PC) |!!|09:19| 00013|180| + |086|185-175 120-090 120-078|F25D(PC) |OK|09:20| 00014|179|098|086|185-175 120-090 120-078|F25C(PC)

  • Page 16: Chapter 6 - Optional Accessories

    Chapter 6 – Optional Accessories Chapter 6 – Optional Accessories Work table “comfort“ Work table “comfort” is placed directly in front of the sealing device. The work table is fitted with smooth running rollers on which heavy/lengthways wrapped instruments or cartridges can glide easily. This represents the ideal precondition to safe and comfortable sealing.

  • Page 17: Chapter 7 - Maintenance

    Chapter 7 – Maintenance Chapter 7 – Maintenance Cleaning and regular controls Period Cleaning and control after 6 months The outside of the sealing device should be cleaned at least twice a year. Only use a lint-free damp cloth stainless steel-cleaning agent suitable for use with medical products.

  • Page 18: 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 technical support department. PLEASE NOTE If an error message is displayed during a sealing procedure, this must be cleared by pressing the key.
  • Page 19 Use sufficient film so that no instruments are able to enter the sealing device and block the sealing procedure. sealing procedure. The pre-set maximum sealing On repeated occurrence, inform your MELAG force has been mal-adjusted. customer services. TEMP 1 The temperature does not...

  • Page 20: 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 21 125.00 € plus VAT (state 01/2017). After the film test strips have been tested, MELAG will issue verification of testing and if successful, a certificate. This certificate confirms conformity of the seal seam with the standard DIN EN 868-5, Appendix D.

  • Page 22: Din Specifications

    DIN Specifications DIN Specifications Concepts 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 23: 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 from October 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 24: Accessories And Replacement Parts

    Angle adapter for RS232 socket 80210 Device fuses; 3,15 A T 5x20 74320 Technical Data Model name MELAseal Pro Device dimensions (WxDxH) 46 x 29.5 x 15.5 cm Weight 11.4 kg Electrical connection 220 = 9 kW, 50 = 60 Hz Power input max.
  • Page 26 MELAG Medizintechnik oHG Geneststraße 6-10 10829 Berlin Germany E-Mail: info@melag.de Web: www.melag.com Responsible for content: Technical Office We reserve the right to technical alterations Your stockist:...

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