172 Instructions for use Babyleo TN500 SW 1.0n
Reprocessing
11.4 Classification for reprocessing
11.4.1 Classification of medical devices
Medical devices and their components are classified according to the way they are
used and the resulting risk.
11.4.2 Classification of device-specific components
The entire device must be reprocessed. Observe the following classification and the
instructions for use for the components.
11.5 Recommendations for reprocessing
11.5.1 Validated reprocessing procedure
The effectiveness of the reprocessing procedures listed has been validated by
independent laboratories certified to ISO 17025.
At the time of validation, the following reprocessing procedures showed good
material compatibility and effectiveness:
Surface disinfection
Surface disinfection using the following surface disinfectant is suitable for the
device and all components (non-critical and semi-critical):
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
Classification Device-specific components
Non-critical – The entire device and all components that can be dis-
mantled (e.g., the mattress tray, fan impeller, hood,
hose grommets)
– The heated mattress (option) and the SoftBed mat-
tress
Semi-critical -
Critical -
Class of active
ingredient
Product name Manufacturer Contact
time
Concentra-
tion
Oxygen-releasing
agents
Dismozon plus BODE Chemie 15 min 1,6 %
To Next Page
Loading...
