Technical Service - Aesculap OL460R Instrucciones De Manejo/Descripción Técnica

Phase III
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Fully immerse the product in the disinfectant solution.
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Mobilize non-rigid components, such as set screws, joints, etc. during rinsing.
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Rinse lumens at least 5 times at the beginning of the exposure time using an appropriate disposable syringe.
Ensure that all accessible surfaces are moistened.
Phase IV
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Rinse/flush the product thoroughly (all accessible surfaces).
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Mobilize non-rigid components, such as set screws, joints, etc. during final rinse.
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Rinse lumens with an appropriate disposable syringe at least five times.
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Drain any remaining water fully.
Phase V
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Dry the product in the drying phase with suitable equipment (e.g. cloth, compressed air), see Validated cleaning
and disinfection procedure.
3.8 Mechanical cleaning/disinfection
Note
The cleaning and disinfection device must be of tested and approved effectiveness (e.g. FDA approval or CE mark
according to DIN EN ISO 15883).
Note
The cleaning and disinfection device used for processing must be serviced and checked at regular intervals.
3.8.1 Mechanical alkaline cleaning and thermal disinfecting
Machine type: single-chamber cleaning/disinfecting machine without ultrasound
Phase Step D
[°C/°F]
I Prerinse <25/77
II Cleaning 55/131
III Intermediate rinse >10/50
IV Thermal disinfecting 90/194
V Drying -
DW: Drinking water
FD–W: Fully desalinated water (demineralized, low microbiological contamination: drinking water quality
at least)
*Recommended: BBraun Helimatic Cleaner alcaline
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Check visible surfaces for residues after mechanical cleaning/disinfecting.
3.9 Inspection
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Allow the product to cool down to room temperature.
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Dry the product if it is wet or damp.
3.9.1 Visual inspection
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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.
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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.
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Check the product for missing or faded labels.
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Check the surfaces for rough spots.
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Check the product for burrs that could damage tissue or surgical gloves.
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Check the product for loose or missing parts.
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Immediately put aside damaged or inoperative products and send them to Aesculap Technical Service, see Tech-
nical service.
3.9.2 Functional test
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OL461R: Assemble disassembled product.
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Check that the product functions correctly.
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Immediately put aside inoperative products and send them to Aesculap Technical Service, see Technical service.
3.10 Packaging
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Place the product in its holder or on a suitable tray.
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Package trays appropriately for the sterilization process (e.g. in Aesculap sterile containers).
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Ensure that the packaging provides sufficient protection against contamination of the product during storage.
3.11 Steam sterilization
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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).
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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
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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: ats@aesculap.de
Other service addresses can be obtained from the address indicated above.
t Water Chemical/Note
quality
[min]
3 D–W -
■
10 FD-W
Concentrate, alkaline:
– pH ~ 13
– <5 % anionic surfactant
■
working solution 0.5%
– pH = 11*
1 FD-W -
5 FD-W -
- - According to the program for cleaning
and disinfection device
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.
TA016022 2021-03 Change No. 63662