Durr Dental 2032-50, Инструкция по установке и эксплуатации

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13 Reprocessing
13.1 Risk analysis and categorisa-
tion
A risk analysis and categorisation of medical
products often used in dentistry must be per-
formed before their reprocessing by the operator.
Comply with all national directives, standards and
specifications such as e. g. the "Recommenda-
tions from the Commission for Hospital Hygiene
and Infection Prevention".
Accessories of the medical device are also sub-
ject to reprocessing.
Classification recommendation given intended
use of the product:
semi-critical B to critical B
Semi-critical medical product:
A medical product which comes into contact
with mucous membrane or pathologically affec-
ted skin.
Critical medical product:
a medical product which also comes into contact
with injured skin and blood.
13.2 Preparation process in
accordance with ISO 17664
Carry out the procedure for reprocessing after
every treatment in accordance with the prepara-
tion process set out in ISO 17664.
Important information!
The reprocessing notes in accordance
with ISO 17664 have been independently
tested by Dürr Dental for the preparation
of the device and its components for their
reuse.
The person conducing the reprocessing is
responsible for ensuring the reprocessing
performed using the equipment, materials
and personnel achieves the desired
results. This requires validation and rou-
tine monitoring of the reprocessing proc-
ess. Any deviation from the instructions
described herein by the staff preparing
the equipment could lead to lower effec-
tiveness and possible negative conse-
quences: these lie solely with the staff
responsible.
Frequent reprocessing has little effect on
the device components. The end of the
product life cycle is especially influenced
by the amount of wear and tear or dam-
age resulting from its use.
The use of soiled, contaminated and
damaged components is at the sole
responsibility of the person performing the
reprocessing and the operator.
Usage
32 9000-615-32/02 2012V003
EN