Classifications For Reprocessing - Dräger Atlan A300 Instructions For Use Manual

Reprocessing
13.3

Classifications for reprocessing

13.3.1 Classification of medical devices
Medical devices and their components are classified according to the way they are
used and the resulting risk.
Classification
Non-critical
Semi-critical
Critical
13.3.2 Classification of device-specific components
Follow the instructions for use for the components.
The following classification is a recommendation from Dräger.
Non-critical
– Device surfaces
Semi-critical
– Breathing system:
– Upper part of the breathing system, lower part of the breathing system
– Nozzles, flow sensors, APL valve
– Non-return valves (yellow and blue)
– Fresh-gas decoupling valve (black)
– Sensor cap of the O
– Bag elbow
– Absorber container and absorber insert
– Piston diaphragm
– Breathing bag arm (option)
– CLIC adapter (option)
Critical
The device does not contain any components that are classified as critical.
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Explanation
Components that come only into
contact with skin that is intact
Components that carry breathing
gas or come into contact with
mucous membranes or pathologi-
cally altered skin
Components that penetrate skin
or mucous membranes or come
into contact with blood
sensor
2
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Instructions for use Atlan A300, A300 XL, A350, A350 XL SW 1.0n
Reprocessing
Surface disinfection with
cleaning (see page 229)
Machine cleaning with ther-
mal disinfection (see
page 242)
Machine cleaning with ther-
mal disinfection followed by
sterilization