hm 950 DC-V/VI NanoPak
Validatable rotary sealer with touch screen and printer
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hm 950 DC-V/VI NanoPak
The new heat sealer surpasses all its predecessors, offering smart operation, comprehensive digitisation, networkability and sustainability, reflecting the spirit of industry 4.0.
The design of the NanoPak is based on the award-winning design of hawo’s Generation Easy series. We have designed the devices of this product generation to meet the high standards, in terms of professionalism, aesthetics and solidity, as required in surgeries and SPD (CSSD’s) in hospitals while always conforming to the strictest safety guidelines.
The NanoPak is available in stainless steel, as well as the colours diamond black, white and original orange.The colour ‘original orange’ dates back to the colour of the first hawo sealing devices issued in the first years after the company was founded.
AppCtrl – Touch Screen
NanoPak is hawo’s most powerful heat sealer. Below the lid is a high-end processor to ensure that NanoPak can deliver top results over a long time period. A 4,3 inch touch screen and the Linux operating system together with the AppCtrl user applications, which allow you to call up instrument and programming functions, make operation and validation child’s play.
DocLink – Communikation
Due to the innovative DocLink communication module NanoPak can easily be linked to batch documentation systems. DocLink has USB A/B and RS 232 interfaces. An additional Ethernet interface makes NanoPak network-compatible.
DataMatic – USB Data Transfer
Thanks to DataMatic technology all data can be continuously recorded on a standard USB stick.
SizeMatic – Determining Bag Length
NanoPak is the first rotary sealing device with SizeMatic function. Sterilisation bags that are too long or too short are a thing of the past because the optional scanner and the SizeMatic scale allows you to upload the length of a device. The optimum length of the bag is then automatically calculated and shown on-screen. All normative-relevant safety margins are considered and included in the calculation.
IntelligentScan – Programming
NanoPak can be operated as usual with a scanner. Entering data is now even more convenient and more secure. With hawo IntelligentScan technology you can enter all the relevant device configurations, such as packaging materials, print and personnel data, as well as the print sequences beforehand, via the PC software. hawo IntelligentScan
FontMatic – Printer
NanoPak‘s new printer is capable of not only printing the required text information, but it can also print bar codes.Make your selection via the print application. The FontMatic technology automatically adjusts the font size to match the width of the packaging. hm 950 DC-VI Version comes with an additional new printig unit, which is able to print international language characters (e.g. Chinese) and logos.
SealPeak – Seal Strength
The tried and trusted hawo SealPeak technology for the sealing seam. Hawo SealPeak sealing seams are 12 mm (0,5 inch) wide, flat seams with a so called barrier of extremely high solidity at their centre, the SealPeak. The seal strength increases steadily from the edges towards the SealPeak. The advantage of these soft edges is that the instruments cannot break through the edges, but gently pierce them and are then caught by the SealPeak at the centre. Furthermore SealPeak sealing seams have outstanding peel properties and do not fray, even if the peel direction is disregarded by the user. Obviously NanoPak is suitable for the sealing of all known, sealable, pre-fabricated sterile barrier systems, uncoated Tyvek, as well as polyoefine packaging.
ValiUp – Validation
NanoPak has been fitted with the new system-integrated function to determine the optimum sealing temperature during process validation (ValiUp). This innovative tool complies exactly with the pre-set process of the international Guidance on the application of ISO 11607-1 and ISO 11607-2 (CEN ISO/TS 16775).
GreenTek – Sustainability
Environmental protection and sustainability are not an end unto themselves. With NanoPakwe are consistently focusing on resource-efficient design with our innovative sealing technology, which only needs a fraction of the energy required by similar devices. The heating works with the highly efficient 24 Volt system which reduces any drop in performance to a minimum. The stand-by function and automatic shut-down, when not in use, complete the hawo‘s GreenTek concept. We offer all this without compromising the quality of the sealing result
- Validatable sealing process according to EN ISO 11607-2 and the international guidance ISO/TS 16775
- Integrated printer with FontMatic
- Data transfering on USB-Stick
- Touch screen
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.
- IQ Installation Qualification: essential information is checked according to a checklist (e.g. the sealing device is compliant to ISO 11607-2)
- OQ Operational Qualification: the optimal sealing temperature has to be established
- PQ Performance Qualification: determination of the seal strength at the optimal sealing temperature determined in the OQ (after sterilisation)
hm 950 DC-V/VI NanoPak