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ISO 13485 and ISO 9001 conducted by the certification agency BSI. This guarantees that all MELAG products are manufactured and tested in accordance with strict quality criteria.
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General Guidelines Please read these operating instructions carefully before commissioning the sealing device. The instructions include important safety information. The functionality and value-retention of this autoclave depend on the care accorded to it. Make sure to keep the Operating Manual near to the device. It represents a component of the product. User Group This manual is targeted at doctors, medical assistants and service.
Contents Contents Chapter 1 – Performance Specifications ..................5 Proper use ..................................5 Chapter 2 – Device Description ....................... 6 Views of the device ................................6 Control lamp status display and acoustic signals ......................7 Chapter 3 – Initial Commissioning ....................8 Transport and storage ..............................
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Never open the housing of the sealing 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 sealing device is opened by anyone other than a member of a MELAG-authorized technical customer service.
MELAfol. Should you wish to use packaging materials other than those specified above, please consult your stockist first or contact MELAG directly. Unsuitable foils and materials Tubular film (double-sided film) is not suitable for use in this sealing device as these types tend to ...
Chapter 2 – Device Description Control lamp status display and acoustic signals Table 1: Explanation of the warning lights and the acoustic signals Warning Possible cause Risk management lights/acoustic signals ● The sealing device is currently Please wait until the pre-set sealing warming up or cooling down temperature has been reached.
Chapter 3 – Initial Commissioning Chapter 3 – Initial 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. ...
Chapter 3 – Initial Commissioning 16.5 cm Insert two rawl plugs (6mm) with round-head screws (Ø3.5 x 45 mm) in the bore holes. Hang the sealing device on the screws. Connecting the sealing device Connecting the sealing device Check the following before connecting the sealing device: The device power switch is off.
Chapter 3 – Initial Commissioning Commissioning Switching on the sealing device Activate the sealing device at the power switch. The LED at the front of the sealing device (Fig. 1/(2)) will illuminate yellow after switching on. As soon as the control lamp is continuously illuminated green, the pre-set sealing temperature has been reached and the sealing device is ready to operate.
Chapter 3 – Initial Commissioning Press the lever forwards to its fullest extent until it clicks. Leave the lever depressed as long as the control lamp flashes green in short intervals (for 3 seconds). When the control lamp is continually illuminated green again, return the leaver to its starting position.
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Chapter 3 – Initial Commissioning Leave the lever depressed as long as the control lamp flashes green in short intervals (for 3 seconds). To cut the film during the sealing process, move the knife handle to the other end of the sealing device quickly.
The sealing temperature is determined by the type of sterilization packaging. When using MELAfol transparent sterilization packaging as provided by MELAG, the rotary knob should point to the middle area marked with “MELAFOL” (corresponds to 180°C).
Chapter 4 – Optional Accessories Chapter 4 – Optional Accessories Reel dispenser “standard” The reel 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.
Chapter 4 – Optional Accessories The reel dispensers “Comfort“ and “Deluxe” are hooked onto the brackets on the rear of the sealing device. Reel dispenser "Comfort"/”Deluxe” (Rear detail view) Wall-mounted reel dispenser Mounted on the wall directly over the sealing device, the wall- mounted roll dispenser saves space.
Chapter 5 – Maintenance Chapter 5 – Maintenance Cleaning and regular controls 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. It should not deposit any oily residue. Observe the following instructions when cleaning: Before every cleaning switch off the sealing device at the power switch and remove the power plug.
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Chapter 5 – Maintenance Return the screws. Replace the unit housing and secure with the Torx screws. Press the fore housing cover against the rear housing cover in order to return the Torx screws. PLEASE NOTE When assembling the sealing device, ensure that the blade is able to move freely from side to side.
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 Annually...
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125.00 € plus V.A.T. (state 01/2015) 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.
DIN Specifications DIN Specifications Terms Sterile barrier system DIN EN ISO 11607-2:2006 replaces the terms "packaging" "final packaging" and immediate 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.
13330 mounted reel dispenser Distance plate (1 pcs) for reel dispenser "Deluxe" 88110 Distance plate for reel dispenser "standard" (2 pcs.) 72330 MELAG seal check 01079 Replacement parts Knife blade 17781 Knife holder black (without blade) 45610 knife handle black...
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MELAG Medizintechnik oHG Geneststraße 6-10 10829 Berlin Germany E-Mail: info@melag.de Web: www.melag.de Responsible for content: Technical Office We reserve the right to technical alterations Your stockist:...
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