3.10.2 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 alkaline
►
Check visible surfaces for residues after mechanical cleaning/disinfecting.
3.11
Inspection
►
Allow the product to cool down to room temperature.
►
Dry the product if it is wet or damp.
3.11.1 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 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.
3.11.2 Functional test
CAUTION
The product may become damaged (metal pitting/fretting corrosion) if insufficiently oiled!
►
Oil any moving parts (e.g. joints, spool parts and threaded rods) prior to the functional test using oil suit-
able for the applied sterilization process (e.g. STERILIT® I oil spray JG600 for steam sterilization or
STERILIT® I drip-feed lubricator JG598).
►
Assemble disassembled products, see Assembly.
►
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.
3.12
Assembly
►
Slide the movable measuring arm
a
onto the rod length measuring instrument.
3.13
Packaging
►
Place the product in its holder or on a suitable tray. Ensure that sharp edges are covered.
►
Package trays appropriately for the sterilization process (e.g. in Aesculap sterile containers).
►
Ensure that the packaging provides sufficient protection against contamination of the product during storage.
3.14
Steam sterilization
Note
FW729R: The product may only be sterilized in a disassembled state.
►
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
– Disassemble the product
– Steam sterilization in a fractionated vacuum process
– Steam sterilizer in accordance with DIN EN285 and validated in accordance with DIN EN ISO 17665
– Sterilization in a 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.
3.15
Storage
►
Store sterile products in germ-proof packaging, protected from dust, in a dry, dark, temperature-controlled area.
4.
Technical service
CAUTION
Modifications to medical equipment may result in the voiding of any guarantee/warranty claims and any
approvals.
►
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.
TA014587 2020-03 V6 Change No. 62188
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
-
-
-
In accordance with the program for the
cleaning and disinfecting machine
