B.Braun Aesculap DX646T Mode D'emploi page 5

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Note the information on appropriate cleaning brushes and disposable syringes, see Validated cleaning and dis-
infection procedure.
Phase I
►
Clean the product in an ultrasonic cleaning bath (frequency 35 kHz) for at least 15 min. Ensure that all accessible
surfaces are immersed and acoustic shadows are avoided.
►
Clean the product with a suitable cleaning brush in the solution until all discernible residues have been removed
from the surface.
►
If applicable, brush through non-visible surfaces with an appropriate cleaning brush for at least 1 min.
►
Mobilize non-rigid components, such as set screws, links, etc. during cleaning.
►
Thoroughly rinse through these components with the cleaning disinfectant solution (at least five times), using a
disposable syringe.
Phase II
►
Rinse/flush the product thoroughly (all accessible surfaces) under running water.
►
Mobilize non-rigid components, such as set screws, joints, etc. during rinsing.
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 alkaline
►
Check visible surfaces for residues after mechanical cleaning/disinfecting.
Inspection, maintenance and checks
Note
Not applicable for implants.
Damage (metal seizure/friction corrosion) to the product caused by insufficient
lubrication!
►
Prior to function checks, lubricate moving parts (e.g. joints, pusher compo-
nents and threaded rods) with maintenance oil suitable for the respective ster-
CAUTION
ilization process (e.g. for steam sterilization: Aesculap STERILIT® I oil spray
JG600 or STERILIT® I drip lubricator JG598).
►
Allow the product to cool down to room temperature.
►
After each complete cleaning, disinfecting and drying cycle, check that the product is dry, clean, operational, and
free of damage (e.g. broken insulation or corroded, loose, bent, broken, cracked, worn, or fractured components).
►
Dry the product if it is wet or damp.
►
Repeat cleaning and disinfection of products that still show impurities or contamination.
►
Check that the product functions correctly.
►
Immediately put aside damaged or inoperative products and send them to Aesculap Technical Service, see Tech-
nical Service.
►
Check for compatibility with associated products.
Packaging
►
Place the product in its holder or on a suitable tray. Ensure that all cutting edges are protected.
►
Pack trays appropriately for the intended sterilization process (e.g. in Aesculap sterile containers).
►
Ensure that the packaging provides sufficient protection against recontamination of the product during storage.
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 fractionated 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 or as per locally approved pol-
icies and procedures
►
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.
Storage
►
Store sterile products in germ-proof packaging, protected from dust, in a dry, dark, temperature-controlled area.
t Water Chemical
quality
[min]
3 D–W -
■
10 FD-W
Concentrate, alkaline:
– pH = 13
– <5 % anionic surfactant
■
0.5 % working solution
– pH = 11*
1 FD-W -
5 FD-W -
- - According to the program for cleaning
and disinfection device
Application
Risk of implant malfunction due to incorrect application!
►
Pre-drill the screw holes, observing the correct burr hole dimensions.
►
Take care that the screwdriver movement causes as little libration (wobble) of
the screw as possible when inserting the bone screws.
WARNING
►
Drive in the screw on the screwdriver axis. Do not tilt the screw.
►
Remove the screws as soon as the healing process is complete.
Injury to the digestive tract/dyspnea caused by swallowing/aspiration of bone
screws!
►
Use the screw holding sleeve.
►
Take care to ensure that the bone screw does not drop from the screwdriver
WARNING
blade while guiding it into the operating field.
Note
The following warning notices apply for spiral drills DX629R to DX631R.
Risk of injury and material damage due to inappropriate use of tools!
►
Always follow the safety advice and information given in the instructions for
use.
►
When coupling/uncoupling, handle tools with cutting edges with care.
WARNING
Risk of burns to skin and tissue caused by blunt tools!
►
Use tools only if they are in perfect condition.
►
Replace blunt tools.
WARNING
Risk of injury to patients and users caused by tools bent or broken during opera-
tion!
►
Avoid overstraining (e.g. bending) of tools during operation.
WARNING
Burr hole dimensions
∅ 1.2 mm (gray magazine)
Screw system
∅ 1.0 mm
Pilot hole in the bone fragment/jaw
bone
(blue marking)
∅ 1.25 mm
Slide hole in the bone fragment
(yellow marking)
The following conditions must be fulfilled prior to application:
■
All requisite implant components are ready to hand
■
The implantation instruments, including the special Aesculap implant system instruments, are complete and in
working condition.
■
Appropriate clinical training as well as a theoretical and practical command of all the required operating tech-
niques, including the use of this product, are prerequisites for the successful use of this product.
■
Information has been obtained from the manufacturer in the event of an ambiguous preoperative situation and
if implants are present in the area to be treated
The surgical procedure and following information has been explained to the patient, and the patient's consent has
been documented:
■
The implant components must not be overloaded by extreme strains, hard physical labor, or sports.
■
The patient must be informed about the limits of allowable strain on the implant, and be given appropriate
behavior guidelines. The risks of transgressing these rules must be explained to the patient. The patient must
undergo a regular medical follow-up examination.
Pre-drill the bone fragment and the jaw bone with a pilot burr (∅ 1.0 mm or ∅1.25 mm).
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Drill out the pre-drilled bone fragment with a slide hole burr (∅ 1.25 mm or ∅ 1.5 mm).
►
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Fixate the bone fragment with bone screws.
Further information on implant systems is available from B. Braun/Aesculap or the appropriate B. Braun/Aesculap
office.
Technical Service
Risk of injury and/or malfunction!
►
Do not modify the product.
WARNING
►
For service and repairs, please contact your national B. Braun/Aesculap agency.
Modifications carried out on medical technical equipment may result in loss of guarantee/warranty rights and for-
feiture of applicable licenses.
Service addresses
Aesculap Technischer Service
Am Aesculap-Platz
78532 Tuttlingen / Germany
Phone: +49 (7461) 95-1602
Fax: +49 (7461) 16-5621
E-Mail: ats@aesculap.de
Other service addresses can be obtained from the address indicated above.
Disposal
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Adhere to national regulations when disposing of or recycling the product, its components and its packaging!
TA-Nr. 012829 2018-11 V6 Änd.-Nr. 59339
∅ 1.5 mm (yellow magazine)
∅ 1.25 mm
(yellow marking)
∅ 1.5 mm
(red marking)