MELAG MELAseal 200 Operating Manual
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MELAG MELAseal 200 Operating Manual

Sealing device
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Operating Manual
MELAseal
Sealing device
from software version 2.22
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
management system is subject to close monitoring: one instrument to this end is our annual multi-day audit conducted in
accordance with 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
"competence in

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Summary of Contents for MELAG MELAseal 200

  • Page 1 2.22 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

    Documenting the sealing process ............................ 17 Using the USB flash drive as an output medium........................ 17 Computer as output medium.............................. 18 Structure of the log files .............................. 18 7 Function tests .................................. 20 Function test with MELAG seal check.......................... 20 8 Settings .................................... 22 Access settings menu ................................ 22 Time .................................... 22 Date.................................... 23 Sealing temperature................................ 23...
  • Page 4 Contents 11 Optional accessories ............................... 30 Roll dispenser “standard” .............................. 30 Roll dispenser “comfort” .............................. 30 Roll dispenser "Deluxe“.............................. 31 Wall-mounted roll dispenser............................... 31 12 Malfunctions .................................. 32 13 Manufacturer's Recommendation for Routine Operation .................... 35 14 DIN Specifications ................................ 37 15 Accessories and spare parts ............................ 39 16 Technical Data .................................. 40...

  • Page 5: General Guidelines

    1 General guidelines 1 General guidelines Please read this operating manual carefully before commissioning the product. The instructions include important safety information. The functionality and value-retention of this device depend primarily on the care accorded to it. Make sure to keep the Operating Manual near to the device. It represents a component of the product.

  • Page 6: Safety

    Never open the housing of the 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 device is opened by anyone other than a member of a MELAG-authorized technical customer service.

  • Page 7: 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 as those named above, please consult your stockist first or contact MELAG directly. Unsuitable materials ▪...

  • Page 8: Views Of The Device

    3 Description of the device Views of the device 1 Knife handle 2 Display with control lamp Fig. 1: Front view 3.1 Bracket for roll dispenser 3.2 Bracket for roll dispenser 4 Socket for power cable 5 USB interface (type B) for connection to the computer Fig. 2: View from rear 6 USB interface for the USB flash...

  • Page 9: Menu Structure

    User 02 ├ ├ User... User... │ └ User 10 User 10 ├ Seal chk Function test with MELAG seal check │ ├ Approve? Performing function test with seal check │ └ Reminder Activate reminder for seal check │ ├...

  • Page 10: Status Display And Acoustic Signals

    3 Description of the device Pressing the keys repeatedly enables navigation to the ring menu. Pressing returns you to the next highest menu level. Status display and acoustic signals Table 1: The meaning of the control lamps and signal tones Control lamp/ Possible cause Measure acoustic signal...

  • Page 11: Commissioning

    The device must be protected against blows or vibration. Space requirements Fig. 5: View from the front and right Table 2: Space requirement and the clearance to be maintained from the surrounding surfaces Dimensions MELAseal 200 Width 36.5 cm Width including lever 40.5 cm...

  • Page 12: 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 network 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 13: Sealing Procedure

    5 Sealing procedure 5 Sealing procedure Sealing procedure with pre-finished film bags 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 cutting bar or in the area of the rear and fore paper guide directly.

  • Page 14: Sealing Procedure For Film Rolls

    5 Sealing procedure Leave the lever depressed as long as the progress bar in the display completes and the control lamp flashes green in short intervals. When the display switches to Open and the control lamp is continually illuminated green again, return the lever to its starting position.
  • Page 15 5 Sealing procedure 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;...
  • Page 16 5 Sealing procedure Press the lever forwards to its fullest extent until it snaps. Leave the lever depressed as long as the progress bar in the display completes and the control lamp flashes green in short intervals. When the display switches to Open and the control lamp is continually illuminated green again, return the lever to its starting position.

  • Page 17: Logging

    6 Logging 6 Logging Documenting the sealing process 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 18: Computer As Output Medium

    Firmware 1.12 requires MELAview Doku/MELAtrace version 3.0.15.1. ü Firmware 2.10 and above requires MELAview Doku/MELAtrace from version 3.6.2.1. Install the MELAseal 200 PC driver on your computer. The driver can be downloaded 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 19 6 Logging Key: Row 10 - Description of the sealing device Row 15 – Date of sealing procedure Row 20 – Serial number of the sealing device Row 25 – Installed software version Row 30 – Total operating hours Row 35 – Date of the next maintenance ---------- -------------- Stat...

  • Page 20: Function Tests

    7 Function tests Function test with MELAG seal check The MELAG seal check serves to check the function of the seal seam produced by your sealing device. Given daily operation, we recommend performing a function test on a weekly basis.
  • Page 21 Ê The display changes to seal chk and flashes. Prepare the MELAG seal check test strips with the transparent sterilization packaging in accordance with the relevant operating manual and perform a test seal. Ê The sealing log will display the corresponding information "seal chk" in the row above the test seal.

  • Page 22: 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 issued on the display. Press repeatedly in order to navigate to Settings. Press to navigate to the Settings menu.

  • Page 23: Date

    8 Settings Press , to change between On and Off. Ê On = The time is automatically changed to summer or winter time (CET). Ê Off = The time must be changed manually from summer to winter time (CET). Press to save the settings.

  • Page 24: Signal Tones

    8 Settings Signal tones In order to switch off the signal tones where necessary, proceed as follows: ü You are in the menu Settings → Tone. Press to confirm. The display flashes. Press to switch the signal tones on or off. Press to save the settings.
  • Page 25 8 Settings Proceed as follows to set the waiting time until the activation of Eco mode: ü You are in the menu Settings → Eco mode. Press to confirm. Ê The display changes to On/Off. Press to navigate to the Wait Eco option. Press to confirm.

  • Page 26: Force Calibration

    8 Settings Force calibration When the malfunction messages Err_05/Force_Lo or Err_06/Force_Hi are displayed, before contacting the service technician, you may be able to solve the problem by performing a force calibration. This recalibrates the device by setting to a pre-set tolerance range. It is only necessary to summon the authorized customer services / stockist technician if this tolerance range is exceeded.

  • Page 27: Maintenance

    A software update is performed by service technicians during maintenance. If necessary, you can perform an update yourself: Contact your stockist/MELAG customer services to obtain the current software version. Copy the update files into the main directory of the USB flash drive. The USB flash drive is included in the scope of delivery.
  • Page 28 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.

  • Page 29: Pause Times

    10 Pause times 10 Pause times Pause times The sealing device can remained 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, see Eco Mode and Standby [} page 24].

  • Page 30: Optional Accessories

    11 Optional accessories 11 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 31: Roll Dispenser "Deluxe

    11 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 32: Malfunctions

    Incorrect opening of the housing cover can compromise electrical safety and pose a danger to the user. Never open the sealing device housing cover without authorization. The device may only be serviced by a technician authorized by the MELAG technical support department. The warning and malfunction messages are generally confirmed with...
  • Page 33 (FAT 32, no quick formatting). Rename the USB flash drive on the If necessary, replace the USB flash drive. MELAG recommends the use of a MELAG USB flash drive. There is no connection between the Check the device manager of your sealing device and the PC.
  • Page 34 The maximum time or number of Check the date in the log header If the date sealing procedures since initial is correct, then arrange for a MELAG commissioning or the last stockist or customer services technician to maintenance has been reached.

  • Page 35: 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 control using MELAG seal check with resources and document the results - for criteria and further information, see the MELAG seal check operation...
  • Page 36 MELAG seal seam strength test For validating your sealing processes MELAG provides a seal strength test for a cost price of 125.00 € plus V.A.T. (state 01/2017). After the film test strips have been tested, MELAG will issue a certificate. This certificate confirms conformity of the seal seam with the standard DIN EN 868-5, Appendix D.

  • Page 37: Din Specifications

    14 DIN Specifications 14 DIN Specifications Explanation of terms Term Explanation 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 38 14 DIN Specifications Guidelines for the storage period of sterile medical products according to DIN 58953-8 This standard applies to the delivery, storage, commissioning, transport and provision (including the packaging and marking of all sterile medical products to be used in healthcare institutions such as hospitals and dental and medical practices.

  • Page 39: Accessories And Spare Parts

    Spacer washers (1 pcs.) for roll dispenser "Deluxe" 88110 Distance plate for roll dispenser "standard" (2 pcs.) 72335 MELAG seal check 01079 MELAG USB flash drive (8 GB) for documentation 19901 USB cable, 1.8 m 19902 MELAtrace documentation software 21138...

  • Page 40: Technical Data

    16 Technical Data 16 Technical Data Device type MELAseal 200 Device dimensions (WxDxH) 40.5 x 24 x 15 cm Weight 5.4 kg Electrical connection 200-240 V~, 50/60 Hz* Electrical power 300 W Fuses 1x 2A Max. altitude 2000 m Ambient temperature 5-40 °C...
  • Page 42 MELAG Medizintechnik oHG Geneststraße 6-10 10829 Berlin Germany email: info@melag.com Web: www.melag.com Responsible for content: MELAG Medizintechnik oHG We reserve the right to technical alterations Your stockist...

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