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10.7 Mechanical cleaning/disinfection with manual pre-cleaning
Note
As a matter of principle, the efficacy of the cleaning and disinfection device must be certified (e.g. in accordance with
EN ISO 15883).
Note
The cleaning and disinfection machine used for processing must be serviced and checked at regular intervals.
10.7.1 Manual pre-cleaning using a brush
Phase
Step
T
[°C/°F]
I
Cleaning
RT
(cold)
II
Rinsing
RT
(cold)
D–W:
Drinking water
RT:
Room temperature
Phase I
►
Clean the product in the solution using a suitable cleaning brush until no residue is visible on the surface.
►
If applicable, use a suitable cleaning brush to brush any surfaces that are not visible for at least 1 min.
►
Mobilize non-rigid components, such as set screws and hinges, during cleaning.
►
Then flush these areas thoroughly at least five times with the cleaning disinfectant solution using a disposable
syringe (20 ml).
Phase II
►
Rinse/flush the instrument thoroughly (all accessible surfaces) under running water.
►
Mobilize non-rigid components, such as set screws and hinges, during rinsing.
10.7.2 Mechanical alkaline cleaning and thermal disinfection
Type of device: Single-chamber cleaning/disinfection device without ultrasound
Phase
Step
T
[°C/°F]
I
Pre-rinse
<25/77
II
Cleaning
55/131
III
Neutralization
>10/50
IV
Intermediate rinse I
>10/50
V
Intermediate rinse II
>10/50
VI
Thermal disinfection
90/194
VII
Drying
-
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)
►
Open the links and joints before placing the product on the screen basket.
►
Connect the lumens and channels of individual parts directly to the injector unit's special flushing connector.
►
Check visible surfaces for residues after mechanical cleaning/disinfecting.
10.8 Inspection, maintenance and checks
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-
CAUTION
ilization process (e.g. for steam sterilization: Aesculap STERILIT® I oil spray
JG600 or STERILIT® I drip lubricator JG598).
►
Allow the product to cool down to room temperature.
►
After each complete cleaning, disinfecting and drying cycle, check that the instrument is dry, clean, operational,
and free of damage (e.g. broken insulation or corroded, loose, bent, broken, cracked, worn, or fractured compo-
nents).
►
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.
10.9 Packaging
►
Appropriately protect products with fine working tips.
►
Store products with ratchet locks fully opened or locked no further than in the first notch.
►
Close the locks so that the jaw tips just touch each other.
►
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 sterile Aesculap containers).
►
Ensure that the packaging provides sufficient protection against recontamination of the product during storage.
10.10 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 instruments at the same time in a steam sterilizer, ensure that the maximum permitted
load specified by the manufacturer for the steam sterilizer is not exceeded.
10.11 Storage
►
Store sterile products in germ-proof packaging, protected from dust, in a dry, dark, temperature-controlled area.
t
Conc.
Water
Chemicals
[%]
quality
[min]
>15
1
D–W
B. Braun Stabimed® fresh
1
-
D–W
-
1)
t
Water
Chemicals
quality
[min]
3
D–W
-
10
DI–W
Dr. Weigert neodisher® SeptoClean1 %
2)
Working solution
2
FD–W
B. Braun Helimatic® Neutralizer C
Working solution 0.15 %
1
DI–W
-
1
FD–W
-
5
FD–W
-
-
-
In accordance with the program for the
cleaning and disinfecting machine
11.
Technical Service
Risk of injury and/or malfunction!
►
Do not modify the product.
WARNING
►
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:
ats@aesculap.de
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!
TA011117
2020-06
V6
Change No. 60792
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