The MELAG MELAseal 100+ is a sealing device designed for heat sealing instruments in sterilization packages within medical contexts, such as clinics and dental practices. It complies with EN ISO 11607-2 and German standard DIN 58953-7. While the MELAseal 100+ is not classified as a medical device under the Medical Device Regulation, it plays a crucial role in maintaining hygiene standards by creating secure, sterile barriers for instruments.
Function Description:
The primary function of the MELAseal 100+ is to create strong, consistent seal seams on transparent sterilization packages. This is achieved through an infinitely variable temperature control system, managed by a rotary knob on the left side of the device. The sealing temperature is crucial and depends on the type of sterilization packaging used. For MELAfol reels and pouches, a temperature range of 170-190 °C is recommended, with MELAG suggesting 180 °C (corresponding to the middle of the "MELAfol" marked area on the rotary knob). The device features a heated sealing rail and a sealing lever that, when depressed, initiates the sealing process. An integrated knife handle allows for cutting film reels to the desired length during the sealing procedure.
The device's operational status is indicated by a control lamp and acoustic signals. An orange light signifies heating or cooling, while a flashing red light with a warning signal indicates the sealing lever is depressed during heating or that the pre-set temperature has not been reached. A continuous green light indicates the device has reached the pre-set sealing temperature and is ready for operation. A flashing green light signifies that the pre-set sealing duration (4 seconds) has been reached and the sealing procedure is complete. Malfunctions, such as early release of the sealing lever or prolonged heating, are indicated by a red light and warning signals.
Important Technical Specifications:
- Device Type: MELAseal 100+
- Device Dimensions (W x D x H): 41.5 x 24 x 15 cm
- Weight: 5.4 kg
- Power Supply: 220-240 V, 50/60 Hz | 100-110 V, 50/60 Hz
- Electrical Power: max. 300 W, average 100 W
- Overheat Protection: > 240 °C
- Length of Power Cable: 2 m
- Installation Location: Interior of a building
- Max. Altitude: 2000 m
- Ambient Temperature: 5-40 °C (ideal range 16-26 °C)
- Relative Humidity: max. 80% at 31 °C, max. 50% at 40 °C (decreasing linearly in-between)
- Sealing Temperature Range: 140-195 °C
- Sealing Force: Factory settings, fixed
- Heating Duration (from 25 °C to 180 °C): approx. 200 s
- Sealing Duration: min. 4 s (factory settings, fixed)
- Seal Seam Width: 10 mm
- Seal Seam Length: max. 27.5 cm
Usage Features:
The MELAseal 100+ supports sealing with both pre-finished film pouches and film reels.
- Connecting and Switching On: The device is connected to the power supply via an IEC plug. The sealing lever can be inserted into a square hole on either the right or left side. Once switched on, the control lamp illuminates yellow during the heating phase and turns continuously green when ready for operation.
- Sealing Procedure with Pre-finished Film Pouches: The packaging, with the film side facing upwards, is inserted into the paper guide between the pressure and sealing rails. It's crucial to ensure adequate clearance between the instrument and the seal seam (minimum 3 cm from the instrument to the seal seam and 1 cm from the seal seam to the cutting edge). The sealing lever is then pressed down until it latches. After the control lamp flashes green for approximately 4 seconds and then illuminates continuously green, the lever is raised, and the pouch is removed. A visual inspection of the seal seam is recommended after each procedure.
- Sealing Procedure for Film Reels: For film reels, the end of the reel is guided along the device's rear panel into the lower paper guide (paper side downwards). The film is then slid forward to the desired length. The sealing lever is depressed, and after the green light sequence, the film can be cut using the knife handle while the lever remains depressed. This creates a pouch that can then be filled and sealed on the open side following the same procedure as for pre-finished pouches.
- Suitable Materials: Transparent sterilization packages conforming to EN 868-5, such as MELAfol reels and pouches, are suitable.
- Unsuitable Materials: Pure hose film (double-sided), polyethylene, soft PVC, hard PVC, polyamide, and polypropylene films are not suitable as they can adhere to the sealing rail and impair functionality.
- Installation: The device can be placed on a table or wall-mounted using optional accessories. Wall mounting requires removing perforated panels, drilling boreholes, inserting rawl plugs, and hooking the device onto screws.
Maintenance Features:
Regular cleaning and checks are essential for the device's longevity and proper functioning.
- Cleaning: Before cleaning, the device must be switched off, and the power plug removed. The exterior of the sealing device should be cleaned with a dry or damp, non-fuzzing cloth. For persistent soiling, a neutral fluid cleaner or spirit can be used, or a mild stainless steel cleaning agent with a pH value between 5 and 8. It is critical to prevent water from entering the device's interior.
- Regular Checks: Cleaning should be performed when necessary and every 6 months.
- Pause Times: The device can remain switched on for long operating pauses, but MELAG recommends switching it off to save energy during extended non-use.
- Transport and Storage: The device should be transported and stored in its original or suitable packaging, frost-free, protected against strong shocks/vibrations, and moisture.
- Peel Test: A peel test should be performed routinely. This involves sealing a transparent sterilization package, visually checking the seal seam for consistency and absence of paper residue (no bigger than 10 mm), processing it in a sterilization cycle, and then slowly pulling the seal seam apart by hand. The seal seam should offer noticeable resistance and the paper should not tear. Results should be documented.
- MELAG Seal Seam Stability Test: MELAG recommends an annual seal seam stability test for validation. This involves testing film strips, and successful tests result in a certificate of conformity with EN 868-5 standard, Appendix D. Application forms are available from the MELAG website.
Optional Accessories:
MELAG offers several optional accessories to enhance the sealing process:
- Reel Dispenser Standard: Placed directly behind the sealing device, it holds film reels in position with spacers.
- Reel Dispenser Comfort: Enables space-saving storage of film reels above the sealing device, held in position with lateral spacers.
- Reel Dispenser Deluxe: Stores film reels above the sealing device and features an integrated feeding device with a hand wheel for easy film feeding.
- Wall Mounted Reel Dispenser: Mounted directly over the sealing device to save space.
- MELAcontrol Seal Check and Ink Test: Tools for verifying seal seam integrity.
- Separating Plate for Reel Dispenser Standard: For organizing film reels.
- Spacer Washers: For various reel dispensers to ensure proper reel positioning.
- Sealing Lever (black): A spare part for the MELAseal 100+/200.
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