Quest Engineering ART-LAP-0008, Инструкция по эксплуатации

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Quest Spectrum® Laparoscopes
10
7 Standards/Directives
All laparoscopes are manufactured in accordance with the following directives:
o
Medical device directive 93/42 EWG last changed by 2007/47/EG
o
EN ISO 13485
o
Series of standards IEC 60601
o
Series of standards ISO 8600
o
FDA regulations (FDA Quality System Regulation 21 CFR Part 820) other product and
material-specific standards and regulations
8 Disposal
8.1 General Remarks
For the disposal, mind the following:
 Dispose of the packaging and used parts in accordance with the country-specific regulations.
 Protect the device from access by unauthorized persons.
8.1.1 Wet Disposal
 Use cleaning-active disinfectants.

Completely immerse endoscopes and accessories in a non-corrosive, non-fixing disinfection bath
that is changed daily.
 Leave endoscopes and accessories in disinfection bath for a maximum of 8 hours.
 Before machine cleaning and disinfection, rinse endoscopes and accessories thoroughly under
clear running water.
8.1.2 Dry Disposal

Machine-clean endoscopes and accessories.
For the disposal, mind the following:
 Dispose of the packaging and used parts in accordance with the country-specific regulations.
 Protect the device from access by unauthorized persons.
9 Product Life cycle
Life cycle of medical device: 2 years or 400 cycles
After end of life cycle:
 Check Laparoscopes for: cleanliness, proper functioning, and damage, e.g. insulation, loose,
bent, broken, cracked, worn, missing parts etc.
 If necessary, have Laparoscopes treated by Quest Medical Imaging.
 If necessary, dispose of Laparoscopes correctly (see chapter 8)