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3.6
Cleaning/Disinfection
3.6.1
Product-specific safety information on the reprocessing method
Danger to the patient! The product must not be manually reprocessed.
►
Reprocess the product only in a mechanical washer/disinfector.
Damage to the clamping mechanism of the support arm during processing!
►
Do not immerse the support arm in any fluid.
►
Tighten the clamping handle by turning it clockwise.
Damage to or destruction of the product due to inappropriate cleaning/disinfecting agents and/or excessive temper-
atures!
►
Following the manufacturer's instructions, use cleaning and disinfecting agents
– that are approved for plastic material and high-grade steel,
– that do not attack softeners (e.g., in silicone).
►
Observe specifications regarding concentration, temperature and exposure time.
►
Do not exceed the maximum allowable disinfection temperature of 95 °C.
For products with plasma layers (e.g. Noir instruments), the layer is attacked or removed when special cleaning pro-
cedures with the addition of oxidizing chemicals (e.g. hydrogen peroxide H
►
Do not use oxidizing chemicals for cleaning.
3.6.2
Validated cleaning and disinfection procedure
Validated procedure
Specific requirements
■
Mechanical neutral or mild-alka-
Mount jaws protection on the
line cleaning and thermal disinfec-
product.
tion
■
Place the product on a tray that
is suitable for cleaning (avoid
rinsing blind spots).
■
Connect components with
lumens and channels directly to
the rinsing port of the injector
carriage.
■
To flush the product: Use a
flushing nozzle or flushing
sleeve.
■
Keep working ends open for
cleaning.
■
Place the product on the tray
with all product links and joints
open.
3.7
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.
3.7.1
Mechanical neutral or mild 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 neutral
►
Check visible surfaces for residues after mechanical cleaning/disinfecting.
►
Repeat the cleaning/disinfecting process if necessary.
3.8
Inspection
►
Allow the product to cool down to room temperature.
►
Dry the product if it is wet or damp.
3.8.1
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.
O
) are used.
2
2
Reference
Chapter Mechanical cleaning/dis-
infection and subsection:
■
Chapter Mechanical neutral or
mild alkaline cleaning and
thermal disinfecting
t
Water
Chemical
quality
[min]
3
D–W
-
10
FD-W
Neutral:
■
Concentrate:
– pH neutral
– <5 % anionic surfactant
■
0.5 %* working solution
Mildly alkaline:
■
Concentrate:
– pH = 9.5
– <5 % anionic surfactant
■
0.5 % solution
1
FD-W
-
5
FD-W
-
-
-
According to the program for cleaning
and disinfection device
3.8.2
Functional test
CAUTION
Support arm malfunction due to improper maintenance!
►
Do not lubricate with oil the joints of the support arm.
►
Assemble disassembled products, see Assembly.
►
Check that the product functions correctly.
►
Check that all moving parts are working properly (e.g. hinges, locks/latches, sliding parts etc.).
►
Immediately put aside inoperative products and send them to Aesculap Technical Service, see Technical service.
3.9
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.
►
Open the clamping handle of the support arm by turning it counterclockwise as far as it will go.
3.10 Steam sterilization
►
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.
3.11 Storage
►
Store sterile products in germ-proof packaging, protected from dust, in a dry, dark, temperature-controlled area.
4.
Maintenance and service
4.1
Maintenance
This product is maintenance-free.
In cases of damage, stiffness or insufficient clamping force, please contact your national B. Braun/Aesculap agency,
see Technical service.
4.2
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.
4.3
Accessories / spare parts
Art. no.
Designation
FF280R
Flexible fastening element with ball joint
RT090R
Flexible fastening element with tooth rim
FF151R
Rigid fastening element
RT046P
Adapter for endoscope holder
RT060R
NeuroPilot®
RT079R
Adapter for fixation on endoscope body/eyepiece
RT099R
MINOP® TREND adapter for holding arm
RT081R
Adapter for attaching RT055P
RT068R
MINOP® InVent adapter for holding arm
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.
TA011949
2020-11
V6
Change No. 63662
Publicité
