Classification For Reprocessing; Recommendations For Reprocessing - Dräger Babyleo TN500 Instructions For Use Manual

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.
Classification
Non-critical
Semi-critical
Critical
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.
Classification
Non-critical
Semi-critical
Critical
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):
Class of active
ingredient
Oxygen-releasing
agents
172
Definition
Components that come into contact with intact skin only
Components that carry breathing gas or come into con-
tact with mucous membranes or pathologically altered
skin
Components that penetrate skin or mucous membranes
or come into contact with blood
Device-specific components
– 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
Product name Manufacturer
Dismozon plus BODE Chemie 15 min
Instructions for use Babyleo TN500 SW 1.0n
-
-
Contact Concentra-
time tion
1,6 %