HEBU medical HF 9928-01, Руководство по эксплуатации

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HEBU reusable APC probe
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EN
8.1 Functional check
A newly purchased product must be subjected to a thorough visual and function check after its
delivery and before each use. If a new product has externally visible defects or does not operate
according to the instructions, contact the manufacturer or his responsible representative immediately.
When used as intended, these products are more or less subject to wear, depending on the intensity
of use. This kind of wear is caused by technical factors and cannot be avoided. Therefore carry out a
thorough visual examination and a function test prior to each application of these products. Carry out
all plug connections only with the compatible articles and plug in the plug completely.
Products must be checked for irregularities. Paying attention to cracks, fractures and the occurrence
of corrosion. Carry out a function check in accordance with the intended application of the product.
Defective products must not be used and must have undergone the complete preparatory treatment
process again before being returned.
9 Sterilization
Prior to sterilization, products must undergo cleaning and disinfection, be rinsed off without residue
using demineralized water and subsequently dried. HEBUmedical recommends using a validated
steam sterilization process (e.g. sterilizer in compliance with EN 285 and validated in accordance with
DIN EN ISO 17665-1).
The validated parameters refer to HF-devices. The validated parameters should also be observed for
the other products described, unless a different procedure is explicitly described.
On using the fractionated vacuum method, sterilization must be performed with at least 134°C (USA
132° C) with a minimum dwell period of 3 minutes. Vacuum drying must then be carried out for at
least 20 minutes.
Parameters used for the validation of steam sterilization
Prevacuum 3 times
Sterilization temperature 132 °C
Sterilization time 1,5 minutes (half cycle method)
Drying time 20 minutes
The vapour must be free of ingredients, recommended limiting values of feed water and vapour
condensate are determined through EN 285.
Other sterilization processes are compatible but not validatet from HEBUmedical.
When loading, observe the recommended total weight. After the sterilization, check the sterile product
packaging for damage, and inspect the sterilization indicators.