Quest Engineering ART-LAP-0008, Инструкция по эксплуатации

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Quest Spectrum® Laparoscopes
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1. Clean laparoscopes thoroughly before sterilizing (see chapter 4 Cleaning/disinfection).
2. Make sure that the entire surface is exposed to the sterilization medium.
3. Avoid any contact with metal surfaces.
4. Make sure that laparoscopes are properly secured in the holders.
5. Do not sterilize laparoscopes still in their protective transport sheaths.
6. Sterilize laparoscopes individually and suitably packaged.
5.2 Sterilization method
 Sterilize laparoscopes and accessories according to generally accepted hospital method.
 Observe manufacturer's indications for auxiliaries.
 Make sure that products are packaged according to ISO 11607 and EN 868 for sterilization.
 Carry out sterilization according to EN 13060/EN ISO 17665-1.
 Observe applicable country-specific requirements.
Table 4 Validated Sterilization method.
Parameters
134 °C / 273°F
Double fore-vacuum 132 °C / 270°F
Double fore-vacuum
Sterilization time 3 – 20 min 4 – 20 min
Packaging
Metal sterilization containers,
paper laminate sterilization bags,
Type Steriking Metal sterilization containers,
paper laminate sterilization bags,
Type Steriking
Note: Exclusively vapor-sterilize laparoscopes marked autoclavable.
CAUTION: Do not accelerate cooling of laparoscopes and accessories. This
will cause damage and reduce the product life.
 Allow laparoscopes and accessories to cool down to room
temperature (23 ± 2 °C).
 Open packages after cooling.
5.3 Storage
After sterilizing, store laparoscopes in a dry, dust-free, and well-aired place (free of corrosive
vapors).
5.4 Information on validation
As prescribed by § 4 MPBetreibV, the treatment using a suitable validated method is approved
by a laboratory accredited by the ZLG (Central Authority of the Länder for Health Protection with
regard to Medicinal Products and Medical Devices in accordance with the directives 93/42/ EWG,
90/385/EWG, and DIN EN ISO/IEC.
The following materials and machines were used for the validation:
 Disinfectant: Korsolex®
 Cleaning agent: Neodisher Mediclean by Dr. Weigert
 Neutralizing agent: Neodisher Z by Dr. Weigert
 Cleaner: Miele G7735
 Sterilizing agent: humid heat
6 Accessories/spare parts
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