10.8.2 Mechanical alkaline cleaning and thermal disinfection
Type of device: Single-chamber cleaning/disinfection device without ultrasound
1)
D–W:
Drinking water
DI–W:
Deionized water
1)
The cleaning and disinfection devices listed below were used to verify cleanability: Miele 7836 CD
2)
Prion-deactivating detergent (see Specifications Dr. Weigert neodisher® SeptoClean)
►
Place the product in a tray that is suitable for cleaning (avoiding rinsing blind spots)
►
Place instruments in the tray with their hinges open.
►
Connect components with lumens and channels directly to the rinsing port of the injector carriage.
►
Check visible surfaces for residues after mechanical cleaning/disinfecting.
10.9
Inspection, maintenance and checks
►
Allow the product to cool down to room temperature.
►
After each complete cleaning, disinfecting and drying cycle, check that the product is dry, clean, operational, and
free of damage (e.g. broken insulation or corroded, loose, bent, broken, cracked, worn, or fractured components).
►
Dry the product if it is wet or damp.
►
Repeat cleaning and disinfection of products that still show impurities or contamination.
►
Check that the product functions correctly.
►
Immediately put aside damaged or inoperative products and send them to Aesculap Technical Service, see Tech-
nical Service.
►
Assemble dismountable products, see Assembling.
10.10 Packaging
►
Appropriately protect products with fine working tips.
►
Place the product in its holder or on a suitable tray. Ensure that all cutting edges are protected.
►
Pack trays appropriately for the intended sterilization process (e.g. in Aesculap sterile containers).
►
Ensure that the packaging provides sufficient protection against recontamination of the product during storage.
10.11 Steam sterilization
Note
The product can be sterilized either in disassembled or in assembled condition.
►
Check to ensure that the sterilizing agent will come into contact with all external and internal surfaces (e.g. by
opening any valves and faucets).
►
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 fractional vacuum process at 134 °C, holding time 18 minutes for prion inactivation
►
When sterilizing several products at the same time in a steam sterilizer, ensure that the maximum load capacity
of the steam sterilizer specified by the manufacturer is not exceeded.
10.12 Storage
►
Store sterile products in germ-proof packaging, protected from dust, in a dry, dark, temperature-controlled area.
11.
Technical Service
►
For service and repairs, please contact your national B. Braun/Aesculap agency.
Modifications carried out on medical technical equipment may result in loss of guarantee/warranty rights and for-
feiture of applicable licenses.
Service addresses
Aesculap Technischer Service
Am Aesculap-Platz
78532 Tuttlingen / Germany
Phone:
+49 (7461) 95-1602
Fax:
+49 (7461) 16-5621
E-Mail:
Other service addresses can be obtained from the address indicated above.
12.
Disposal
►
Adhere to national regulations when disposing of or recycling the product, its components and its packaging!
TA010327 2020-06 V6 Change No. 60792
Phase
Step
T
[°C/°F]
t
[min]
Water
quality
Chemicals
I
Pre-rinse
<25/77
3
D–W
-
II
Cleaning
55/131
10
FD–W
Dr. Weigert neodisher® SeptoClean 1 %
Working solution
2)
III
Neutralization
>10/50
2
DI–W
B. Braun Helimatic® Neutralizer C
Working solution 0.15 %
IV
Intermediate rinse I
>10/50
1
FD–W
-
V
Intermediate rinse II
>10/50
1
DI–W
-
VI
Thermal disinfection
90/194
5
FD–W
-
VII
Drying
-
-
-
In accordance with the program for the
cleaning and disinfecting machine
CAUTION
Damage (metal seizure/friction corrosion) to the product caused by insufficient
lubrication!
►
Prior to function checks, lubricate moving parts (e.g. joints, pusher compo-
nents and threaded rods) with maintenance oil suitable for the respective ster-
ilization process (e.g. for steam sterilization: Aesculap STERILIT® I oil spray
JG600 or STERILIT® I drip lubricator JG598).
WARNING
Risk of injury and/or malfunction!
►
Do not modify the product.
