Classifications For Reprocessing; Classification Of Medical Devices; Classification Of Device-Specific Components - Dräger Fabius Tiro SW 3.n Reprocessing Manual

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
Non-critical
Semi-critical
Critical

Classification of device-specific components

Observe the instructions for use for the
components.
The following classification is a recommendation
from Dräger.
Critical
The device does not contain any components
classified as critical.
Non-critical
– Device surface including screen
– Trolley and holders
– Removable parts of the main device
Reprocessing Fabius family
Explanation
Components that come into contact only with skin that is intact
Components that carry breathing gas or come into contact with mucous mem-
branes or pathologically altered skin
Components that penetrate skin or mucous membranes or come into contact with
blood
Semi-critical
– Compact breathing system
– Housing
– Inspiratory valve
– Expiratory valve
– APL valve
– Exhaust port
– Rigid breathing bag arm (option)
– Flexible breathing bag arm (option)
– Absorber container and absorber insert
– Ventilator
– Ventilator lid
– Piston diaphragm
– Ventilator hose
– Screw cap for O sensor housing
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English
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