Dräger Infinity M300 series - Reprocessing of Device-Specific Components; Safety Information; Classification of Medical Devices for Reprocessing

Reprocessing of device-specific components
42 Supplement – Infinity M300 and M300+ Series – VG2.4
Reprocessing of device-specific components
This section provides information for the reprocessing of M300 and M300+ device-specific components
and accessories. Keep this supplement with the instructions for use.
Safety Information
Classification of medical devices for reprocessing
Medical devices and their components are classified according to the way they are used and the resulting
risk.
WARNING
Risk due to inappropriately reprocessed products
Reusable products must be reprocessed, otherwise there is an increased risk of infection.
– Observe the infection prevention policies and reprocessing regulations of the healthcare
facility.
– Observe national infection prevention policies and reprocessing regulations.
– Use validated procedures for reprocessing.
– Reprocess reusable products after every use.
– Observe the manufacturer's instructions for cleaning agents, disinfectants, and reprocessing
devices.
CAUTION
Risk due to faulty products
– Signs of wear, e.g., cracks, deformation, discoloration, or peeling, may occur with reprocessed prod-
ucts.
– Check the products for signs of wear and replace them if necessary.
Classification Explanation
Non-critical Components that come only into contact with skin that is intact
Semi-critical (A, B) Components that carry breathing gas or come into contact with mucous
membranes or pathologically altered skin
Critical (A, B, C) Components that penetrate skin or mucous membranes or come into contact with
blood