Instructions for use Isolette 8000 plus SW 5.n 137
Reprocessing
12.3 Classifications for reprocessing
12.3.1 Classification of medical devices
Medical devices and their components are classified according to the way they are
used and the resulting risk.
12.4 Reprocessing list
Classification Explanation
Non-critical Components that come only into contact with skin that is
intact
Components Surface
disinfection
with cleaning
Machine
cleaning with
thermal
disinfection
Special
reprocessing
measures
Hand port gaskets Yes No No
Hose grommets Yes No No
Controller Yes No No
Shell Yes No No
Trolley Yes No No
Condensation management
bracket (if installed)
Yes No No
Sensor module Yes No No
Hood Yes No No
Inner double walls Yes No No
Heater radiator Yes No No
Fan impeller Yes No No
Manifold No Yes No
Heater/impeller cover No Yes No
Duct cover No Yes No
Water reservoir assembly No Yes No
Humidifier Yes No No
Air inlet filter chamber Yes No No
Air inlet filter cover Yes No No
Rail and accessories Yes No No
Drawers Yes No No
Cylinder holder Yes No No
Utility shelf Yes No No
IV pole Yes No No
Mattress Yes No No