Instructions for use | Oxylog VE300 SW 1.n 101
Reprocessing
12.2 Information on reprocessing
The instructions for reprocessing meet the requirements of ISO 17664.
12.2.1 Information on disinfectants
Use disinfectants that are nationally approved and are suitable for the respective
reprocessing procedure.
12.3 Safety information
WARNING
Risk due to inappropriately reprocessed products
Reusable products must be reprocessed, otherwise there is an increased risk of
infection.
► Observe the hygiene regulations and reprocessing regulations of the healthcare
facility.
► Observe national hygiene regulations 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.
WARNING
Risk of patient injury
Disposable products have been developed, tested, and manufactured for single use
only. Disposable products must not be reused, reprocessed, or sterilized.
► Reuse, reprocessing, or sterilization may lead to a failure of the accessory and
may cause injury to the patient.
CAUTION
Risk due to faulty products
Signs of wear, e.g., cracks, deformation, discoloration, or peeling, may occur with
reprocessed products.
► Check the products for signs of wear and replace them if necessary.
12.4 Classification for reprocessing
12.4.1 Classification of medical devices
Medical devices and their components are classified according to the way they are
used and the resulting risk.
Classification Definition
Non-critical Components that come into contact with intact skin only
Semi-critical Components that carry breathing gas or come into con-
tact with mucous membranes or pathologically altered
skin
Critical Components that penetrate skin or mucous membranes
or come into contact with blood
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