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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.
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...
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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...
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.
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.
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 ▪...
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...
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 │ ├...
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...
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...
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.
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.
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.
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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;...
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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.
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: ▪...
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.
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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...
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.
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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.
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.
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.
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.
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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.
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.
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.
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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.
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].
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"...
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.
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...
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(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.
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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.
▪ 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...
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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.
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.
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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.
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...
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...
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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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