B.Braun Aesculap Ennovate Cervical Mode D'emploi page 4

Phase I
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Clean the product in an ultrasonic cleaning bath (frequency 35 kHz) for 5 min. Ensure that all accessible surfaces
are immersed and acoustic shadows are avoided.
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Do not clean with brushes or other abrasives that would damage the product surface.
Phase II
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Rinse/flush the product thoroughly (all accessible surfaces) under running water.
4.5.2 Mechanical alkaline cleaning and thermal disinfecting
Machine type: single-chamber cleaning/disinfection device without ultrasound
Phase Step T
[°C/°F]
I Prerinse <25/77
II Cleaning 55/131
III Intermediate rinse >10/50
IV Thermal disinfecting 90/194
V Drying -
D–W: 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.
4.6 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.
4.6.1 Visual inspection
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Ensure that all soiling has been removed. In particular, pay attention to mating surfaces, shafts, recessed areas,
drill grooves.
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If the product is dirty: repeat the cleaning and disinfection process.
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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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Immediately put aside damaged or inoperative products and send them to Aesculap Technical Service, see Tech-
nical service.
4.6.2 Functional test
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Check that the product functions correctly.
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Check for compatibility with associated products.
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Immediately put aside inoperative products and send them to Aesculap Technical Service, see Technical service.
4.7 Packaging
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Place the product in its holder or on a suitable tray. Ensure that sharp edges are covered.
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Pack trays appropriately for the sterilization process (e.g. in Aesculap sterile containers).
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Make sure that the packaging will prevent a recontamination of the product during storage.
4.8 Steam sterilization
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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
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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.
4.9 Storage
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Store sterile packed implant components dust-protected in a dry, dark and temperature-controlled room.
4.9.1 Ambient conditions
The following environmental conditions apply to the transport and storage of the product:
Temperature 10 °C to 40 °C
Relative humidity 30 % to 75 %
Atmospheric pressure 700 hPa to 1 060 hPa
5. Technical service
CAUTION
Modifications carried out on medical technical equipment may result in loss of guarantee/warranty rights and
forfeiture of applicable licenses.
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Do not modify the product.
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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.
6. Disposal
WARNING
Risk of infection due to contaminated products!
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Adhere to national regulations when disposing of or recycling the product, its components and its pack-
aging.
TA015777 2020-02 V6
t Water Chemical
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