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12.03.2019
Hygiene

Compact and intelligent: the Hygopac View - Sterile product packaging compliant with the relevant legal requirements

According to the applicable German Medical Devices Operator Ordinance (Medizinprodukte-Betreiberverordnung, MPBetreibV), the reprocessing of medical devices must be performed using suitable, validated procedures. The validation of packaging processes is described in the DIN standard EN ISO 11607-2. With the new Hygopac View, the compact and intelligent rotary sealing device, these requirements are reliably satisfied. The functional and intuitive operating concept via the touch display makes sterile product packaging easier than ever before.

Since dental instruments can also penetrate patients’ skin or mucous membranes and come into contact with blood, they need to be classed as critical and must be made available in sterilised form before every treatment. The packaging of sterile instruments requires the utmost care, as this step is a key factor in the reprocessing chain and definitely includes a number of potential sources of errors.

This makes it even more important that every step in the packaging process can be tested within the framework of process controls – and this needs to be as simple and user-friendly as possible. One thing is certain: during stressful everyday work in dental practices, it is important that additional tasks and obligations can be integrated both safely and smoothly into the normal work processes.

The validation concept for the new Hygopac View system from Dürr Dental supports this objective by guiding the operator with the aid of the intuitive touch display in a step-by-step process through the sub-steps of functional qualification and performance qualification, which are vital for the validation. The sealing temperature, contact pressure and sealing speed are continuously recorded, checked and saved to an SD card or to the network via the VistaSoft Monitor software. This allows effortless processing of the data for documentation within a quality management system. In the event of a practice inspection, the information is available immediately.

Day-to-day use in the dental practice was the main focus during the development of the new Hygopac View sealing system. High-quality components guarantee reliable operation, while the intuitive operating concept ensures quick, simple and reliable sealing processes. On top of this, networking via the VistaSoft Monitor software offers great flexibility in terms of process documentation. And, last but not least, the exceptionally compact design also impresses by keeping space requirements in the reprocessing room to an absolute minimum.


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Hygopac View?

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Compact and intelligent – the Hygopac View

Compact and intelligent – the Hygopac View