Steam Sterilization; Technical Service - Braun AESCULAP 63662 Instructions For Use/Technical Description

3.6 Mechanical cleaning/disinfection
3.6.1 Mechanical neutral or mild-alkaline cleaning and thermal disinfection
Machine type: single-chamber cleaning/disinfecting machine without ultrasound
Phase Step D
[°C/°F]
I Pre-rinse <25/77
II Cleaning 55/131
III Intermediate rinse >10/50
IV Thermal disinfection 90/194
V Drying -
DW: Drinking water
FD–W: Fully desalinated (demineralized) water
►
Check visible surfaces for residues after mechanical cleaning/disinfecting.
►
Repeat the cleaning/disinfection process if necessary.
Note
Temperatures of up to 120 °C are permitted for machine drying with hot air.
3.7 Inspection
►
Allow the product to cool down to room temperature.
►
Dry the product if it is wet or damp.
3.7.1 Visual inspection
►
Remove the reusable filter.
►
Ensure that all contamination has been removed.
►
If the product is dirty: repeat the cleaning and disinfection process.
►
Check the product for damage, e.g. cracked, worn and severely scratched components.
►
Check the product for missing or faded labels.
►
Set aside the product if it is damaged.
3.7.2 Functional test
►
Check for compatibility with associated products.
►
Set aside the product if it is damaged.
3.8

Steam sterilization

►
Validated sterilization process
– Steam sterilization using fractional vacuum process
– Steam sterilizer according to DIN EN 285 and validated according to DIN EN ISO 17665
– Sterilization using fractionated vacuum process at 134 °C/holding time 5 min
►
If several devices are sterilized at the same time in the same steam sterilizer: Ensure that the maximum permitted
load according to the manufacturers' specifications is not exceeded.
4.

Technical service

CAUTION
Modifications carried out on medical technical equipment may result in loss of guarantee/warranty rights and
forfeiture of applicable licenses.
►
Do not modify the product.
►
For service and repairs, please contact your national B. Braun/Aesculap agency.
Service addresses
Aesculap Technischer Service
Am Aesculap-Platz
78532 Tuttlingen / Germany
Phone: +49 7461 95-1601
Fax: +49 7461 16-2887
E-Mail: ats@aesculap.de
Other service addresses can be obtained from the address indicated above.
5. Disposal
WARNING
Risk of infection due to contaminated products!
►
Adhere to national regulations when disposing of or recycling the product, its components and its pack-
aging.
Note
The user institution is obliged to reprocess the product before its disposal, see Validated reprocessing procedure.
TA013138 2021-01 V6 Change No. 63662
t Water Chemistry
quality
[min]
3 D–W –
10 FD–W Neutral:
■
B. Braun Helimatic Cleaner neutral
– pH neutral
– Working solution 0.5 %
Mildly alkaline:
■
Concentrate:
– pH = 9.5
– <5 % anionic surfactant
– Working solution 0.5 %
Alkaline:
Reprocessing is possible up to pH 10.5,
provided the cleaning agent is manu-
facturer-approved for cleaning alumi-
num or plastic sterile containers.
1 FD–W –
5 FD–W Other process parameters may be fea-
sible with agreement by the hospital
hygienist.
- - According to mechanical cleaning pro-
gram