Reprocessing
120 Instructions for use Oxylog 3000 plus SW 1.n
Safety information
Information on reprocessing
Follow the national infection prevention policies
and reprocessing regulations.
Follow the infection prevention policies and
reprocessing regulations of the health-care facility
(e.g., concerning the reprocessing cycles).
Classifications for reprocessing
Classification of medical devices
The classification depends on the intended use of
the medical device.
The risk of infection transmission through the
application of the product to the patient without
proper reprocessing is the basis of the Spaulding
classification.
Classification of device-specific components
The following list is a recommendation from Dräger.
Non-critical
– Surface of the device including screen
– Removable components of the basic unit (e.g.,
accessories bag)
WARNING
Risk due to inappropriately reprocessed prod-
ucts
Reusable products must be reprocessed, oth-
erwise there is an increased risk of infection.
– Follow the infection prevention policies
and reprocessing regulations of the
health-care facility.
– Follow the national infection prevention
policies and reprocessing regulations.
– Use validated procedures for reprocess-
ing.
– Reprocess reusable products after every
use.
– Follow the manufacturer's instructions for
cleaning agents, disinfectants, and repro-
cessing devices.
WARNING
Risk of patient injury
Single-use articles have been developed,
tested and manufactured for single use only.
Disposable products must not be reused,
reprocessed, or sterilized.
Reuse, reprocessing or sterilization can lead
to a failure of the accessories and cause inju-
ries to the patient.
CAUTION
Risk due to faulty products
Signs of wear, e.g., cracks, deformation, discolor-
ation, or peeling may occur with reprocessed
products.
Check the products for signs of wear and replace
them if necessary.
Classification Explanation
Non-critical Components that come into con-
tact only with skin that is intact
Semi-critical Components that carry breathing
gas or come into contact with
mucous membranes or patho-
logically altered skin
Critical Components that penetrate skin
or mucous membranes or come
into contact with blood