3.8.2
Mechanical alkaline cleaning and thermal disinfecting
Machine type: single-chamber cleaning/disinfection device without ultrasound
D–W:
Drinking water
FD–W:
Fully desalinated water (demineralized, low microbiological contamination: drinking water quality
at least)
*Recommended: BBraun Helimatic Cleaner alcaline
►
Check visible surfaces for residues after mechanical cleaning/disinfecting.
3.9
Inspection
►
Allow the product to cool down to room temperature.
►
Dry the product if it is wet or damp.
3.9.1
Visual inspection
►
Ensure that all soiling has been removed. In particular, pay attention to mating surfaces, hinges, shafts, recessed
areas, drill grooves and the sides of the teeth on rasps.
►
If the product is dirty: repeat the cleaning and disinfection process.
►
Check the product for damage, e.g. insulation or corroded, loose, bent, broken, cracked, worn or severely
scratched and fractured components.
►
Check the product for missing or faded labels.
►
Check the products with long, slim shapes (in particular rotating instruments) for deformities.
►
Check the product for damage to the spiral element.
►
Check the cutting edges for continuity, sharpness, nicks and other damage.
►
Check the surfaces for rough spots.
►
Check the product for burrs that could damage tissue or surgical gloves.
►
Check the product for loose or missing parts.
►
Immediately put aside damaged or inoperative products and send them to Aesculap Technical Service, see Tech-
nical service.
3.9.2
Functional test
CAUTION
Damage (metal cold welding /friction corrosion) to the product caused by insufficient lubrication!
►
Prior to function checks, lubricate moving parts (e.g. joints, pusher components and threaded rods) with
maintenance oil suitable for the respective sterilization process (e.g. for steam sterilization: STERILIT® I oil
spray JG600 or STERILIT® I drip lubricator JG598).
►
Check that the product functions correctly.
►
Check that all moving parts are working property (e.g. hinges, locks/latches, sliding parts etc.).
►
Check for compatibility with associated products.
►
Immediately put aside inoperative products and send them to Aesculap Technical Service, see Technical service.
3.10
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 sharp edges are covered.
►
Ensure that the packaging provides sufficient protection against contamination of the product during storage.
3.11
Steam sterilization
Note
To avoid breakage due to stress crack corrosion, sterilize the instruments with the lock fully open or locked no further
than on the first ratchet tooth.
►
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 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.
3.12
Storage
►
Store sterile products in germ-proof packaging, protected from dust, in a dry, dark, temperature-controlled area.
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:
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.
WARNING
Risk of injury due to sharp-edged and/or pointed products!
►
When disposing of or recycling the product, ensure that the packaging prevents injury by the product.
Note
The user institution is obliged to reprocess the product before its disposal, see Validated reprocessing procedure.
TA013977 2020-06 V6 Change No. 62764
Phase
Step
T
[°C/°F]
t
[min]
Water
quality
Chemical
I
Prerinse
<25/77
3
D–W
-
II
Cleaning
55/131
10
FD-W
■
Concentrate, alkaline:
–
pH = 13
–
<5 % anionic surfactant
■
working solution 0.5%
–
pH = 11*
III
Intermediate rinse
>10/50
1
FD-W
-
IV
Thermal disinfecting
90/194
5
FD–W
-
V
Drying
-
-
-
According to the program for cleaning
and disinfection device