Impulse Sealer hm 460/660 AS-V
The validatable hm 460 AS-V and hm 660 AS-V impulse sealing devices are used for sealing sealable pouches and tubes (SPS). The footswitch-operated and magnetic sealing system makes them ideal for constant use (for example in hospitals and the medical industry). The intuitive control unit on the sealing devices makes menu navigation and data entry especially easy. Alternatively, the devices can also be programmed very easily using a barcode scanner (hawo IntelligentScan).
- Fulfills the requirements of the guideline of the World Health Organisation (WHO) as well as the new guideline of the World Federation for Hospital Sterilisation Sciences (WFHSS)
- Validatable sealing process according to EN ISO 11607-2 and the international guidance ISO/TS 16775Integrated film roll storage and cutting device
- No heat-up time and no energy consumption when not in use
- Interface for process documentation software ProDoc
- Optional tray
- Optional communication module SealCom PRO
- Label printer ValiPrint connectable
Work processes in the preparation of instruments should be as simple and comfortable as possible. The work process is in this way eased and a tray is not necessary. The generous handle is ergonomically angled and guarantees an even contact pressure and thereby the maximum sealing safety as well as reproducible and constant sealing results.
Quickly graspable functions and thought through solutions make perfect operation possible. There is room for up to three roll formats side by side. At insertion, the film roll is automatically and exactly positioned. The cutting blade runs in a guiding profile and is securely parked away from the cutting area. In addition, the device can be fastened to the wall with a special mounting.
The correct reprocessing process of medical devices consists of the steps of washing & disinfection, packaging and sterilisation. The instruments can only be called sterilised when they are packaged before the sterilisation. The single-use (!) packaging, made from laminated poly film and a porous material (Tyvek® or medical grade paper) is permeable for the sterilisation medium (e.g. steam, plasma, Formaldehyde FO or Ethylenoxide ETO), but not for bacteria or microorganisms. Only by following this reprocessing sequence and by using professional heat sealers to seal the instruments as well as professional packaging material can the sterility up to the point of use as well as the aseptic presentation of the instrument be guaranteed.
Medical devices delivered in a sterile state should be packed to ensure that they remain sterile until the point of use. The validation of packaging processes is crucial to ensure that sterile barrier system integrity is attained and will remain so until opened by the users.
The international packaging standard ISO 11607-2 as well as the Technical Specification draft ISO/DTS 16775 explain how packaging processes should be validated. The international packaging validation guideline gives guidance how to validate packaging processes. During the validation of the heat sealing process the optimum sealing temperature of the packaging materials used has to be evaluated and established. At this temperature, the process then has to deliver optimum seal seams that are strong enough and peelable.
Professional heat sealing equipment for closing sealable pouches and reels (preformed sterile barrier systems) are essential for this. Hawo therefore offers sealing devices whose processes can be validated according to ISO 11607-2, the Technical Specification draft ISO/DTS 167751 and in harmony with the international packaging validation guideline. The models marked with ‘V’ feature an integrated function for regulating and monitoring process parameters – the ‘V’ is the key! Sealing devices from Hawo therefore guarantee efficient and reproducible packing, even for large volumes of instruments.
|APPLICATION AND CERTIFICATIONS||hm 460 AS-V||hm 660 AS-V|
|Particularly suitable for use in Life Science, medical industry Life Science, medical industry||x||x|
|Compliance with EN ISO 11607-2:2019||x||x|
|Compliance with CEN ISO/TS 16775||x||x|
|Compliance with DIN 58953-7:2010||x||x|
|Mains connection||230/115 V||230/115 V|
|Mains frequency||50/60 Hz||50/60 Hz|
|Power consumption (only during the packaging process)||2,800 W
(16 A, characteristic curve G (K))
(16 A, characteristic curve G (K))
|Dimensions W x D x H||530 x 330 x 220 mm||700 x 330 x 220 mm|
|Weight||25 kg||25.5 kg|
|Seal seam width||8 mm||8 mm|
|Cutting length||360 mm||540 mm|
|Sealable paper pouches according to EN ISO 11607-1/EN 868-4||x||x|
|Sealable pouches and reels according to EN ISO 11607-1/EN 868-5 made of film and paper according to EN 868-3||x||x|
|Sealable pouches and reels according to ISO EN 11607-1/EN 868-5 made of film and uncoated materials made of polyolefine according to EN 868-9 (e. g. Tyvek®)||x||x|
|Sealable pouches and reels according to ISO 11606-1/ EN 868-5 made of PP fleece or PP nonwoven||x||x|
|All types of laminate, including coated aluminium laminat||x||x|
|Polymer materials (e.g. polyethylene, polypropylene, polyolefins, PVC)||x||X|
|PROCESS VARIABLES AND PARAMETERS|
|Sealing temperature||max. 250°C||max. 250°C|
|Sealing time||0.5 – 10 s||0.5 – 10 s|
|Contact pressure||fix > 80 N||fix > 80 N|
|Cooling temperature||50 – 250°C||50 – 250°C|
|Cooling time||0.5 – 10 s||0.5 – 10 s|
Note: Specifications subject to change without prior notice.
hm 450 T Storage tray for hm 460 AS-V
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