Durr Dental Vector Scaler, Инструкция по установке и эксплуатации

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9000-615-32/02 1808V002
29
Usage
Important information!
The reprocessing notes in accordance
with EN ISO 17664 have been independ-
ently tested by Dürr Dental for the prepa-
ration of the device and its components
for their reuse
The person conducing the reprocessing
is responsible for ensuring the reprocess-
ing performed using the equipment, ma-
terials and personnel achieves the de-
sired results This requires validation and
routine monitoring of the reprocessing
process Any deviation from the instruc-
tions described herein by the staff pre-
paring the equipment could lead to lower
effectiveness and possible negative con-
sequences: 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 re-
sponsibility of the person performing the
reprocessing and the operator
The reprocessing procedure was validated as
follows:
– Pre-cleaning
- FD 350 disinfection wipes (Dürr Dental)
- Cleaning brush
– Manual cleaning
- ID 215 enzymatic instrument cleaner (Dürr
Dental)
- Cleaning brush
– Manual disinfection
- ID 213 Instrument disinfection (Dürr Dental)
–
Automatic cleaning and disinfection
Was performed in accordance with EN ISO
15883 with tested efficacy
- Cleaning agent: Neodisher MediClean Forte
- Washer-disinfector: PG 8535 (Miele)
- Programmes: "Cleaning without neutralisa-
tion" and "THERMAL DES"
- Rinsing adapter: Miele 68551101 D
- Cleaning brush
13 Reprocessing
13.1 Risk analysis and
categorisation
A risk analysis and categorisation of medical
products often used in dentistry must be per-
formed before their reprocessing by the opera-
tor Comply with all national directives, stand-
ards and specifications such as e g the "Rec-
ommendations from the Commission for Hospi-
tal 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 affect-
ed skin
Critical medical product:
a medical product which also comes into con-
tact with injured skin and blood
13.2 Reprocessing procedure in
accordance with EN ISO 17664
The reprocessing procedure after each patient
treatment is carried out according to the reproc-
essing procedure established by EN ISO 17664
EN