Komet Trepan bur 227B Instructions For Use

Manufacturer:
Gebr. Brasseler GmbH & Co. KG
Trophagener Weg 25
32657 Lemgo · Germany
Trepan bur 227B
© 08/2012, Gebr. Brasseler GmbH & Co. KG
304970 - Rev 08/2012
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¿ Order number
Numéro d'ordre
Número de pedido
Oral surgery
Chirurgie maxillo-faciale
Oral surgery
227B.204.040
227B.204.050
227B.204.060
227B.204.070
227B.204.080
227B.204.090
227B.204.100
Tab. 1 Stainless steel | Acier inoxydable | Acero inoxidable
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Trepan burs for extraction of bone cylinders
1. Indication
For extraction of bone transplants from suited donating areas in the oral cavity.
2. Contraindication
If anatomic structures adjacent to the bone extraction site are jeopardized. A safety distance of 3 mm has to be
kept. It has to be ensured that the stability of the extraction site will not be affect ed, this refers especially to the
lower jaw.
3. Clinical sequence/proper use
Select the proper size of the trepan bur and determine the drilling depth.
- Size and drilling depth are to be determined with radiograph (bite-wing radiograph and orthopantomogramme).
- In case of larger extractions a computer tomo graphic examination is recommended in addition to the bite-wing
radiograph and the orthopanto mogramme.
Examination of the adjacent structures
- In order to eliminate any danger to the adjacent structures such as tooth root, mouth floor, maxillary antrum or
nerve canal the area surrounding the extraction site has to be carefully examined.
Local anaesthesia has to be carried out in the extraction site of the bone transplant.
- Cut through mucosa and periost until reaching the bone and expose the extraction site.
- When the extraction site is exposed, place the bur on the bone and take care that the surround ing soft tissue is
not harmed.
Note: Avoid leverage of the trepan bur. If necessary, prepare a groove (for instance with a bone cutter) for
centering. Otherwise there is the risk that the trepan bur may slip from the intended extraction site and may
cause injury. Risk of injury can be eliminated if you place hook retractors or suitable instruments, like periosteal
elevators.
- Drill in an intermittent mode with constant exterior cooling with physiological saline solution. The exterior
cooling prevents thermal damage to the bone tissue and in addition bone chips can be washed off.
- Drilling is carried out with light pressure until the required depth is reached. Speed: 800 - 1.000 rpm, green
contra-angle, reduction 10 : 1 at minimum).
Note: A sterile procedure is of utmost importance because an infection of the marrow would have se vere
consequences.
4. Further treatment
Extraction of the bone transplant
After bone transplant separation
- it can be extracted with extraction forceps/tweezers by a slight turning motion
If the bone transplant remains in the trepan bur
- it can be pushed out with tweezers which are introduced through the openings in the trepan bur.
If the bone transplant is still immobile
- it can be loosened by leveraging with a spatula or other suitable instruments
Take care of proper hemostasia in the donation site, if necessary fill with bone substitute.
The wound must be treated and hermetically sealed against saliva and the periost above the extraction must be
adapted.
5. Recommendations for maintenance
The instruments are supplied in non-sterile condition. Therefore instruments have to be disinfected, cleaned and
sterilized prior to every use.
- Do not allow residues from the operation (blood, secretions, tissue) to dry
Distributor/Importer for USA and Canada:
Komet USA LLC
3042 Southcross Blvd, Suite 101
Rock Hill, SC 29730, USA
Phone: 888-566-3887
Fax: 800-223-7485
info@kometusa.com
www.kometusa.com
CAUTION: U.S. Federal law restricts the device
to sale by or on the order of a licensed dentist.
| LOT number
Numéro de lot
Número de lote
Ø outside Ø inside drilling depth
Ø extérieur Ø intérieur profondeur de forage
Ø exterior Ø interior profundidad de taladro
4,0 mm 2,9 mm 8,0 mm
5,0 mm 3,9 mm 8,0 mm
6,0 mm 4,9 mm 8,0 mm
7,0 mm 5,9 mm 8,0 mm
8,0mm 6,9 mm 12,0 mm
9,0 mm 7,9 mm 12,0 mm
10,0 mm 8,9 mm 12,0 mm
Instructions for use
Please read carefully and retain for future reference.
Conseils d'utilisation
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Consult instructions for use
Se reporter aux instructions
Observe indicaciones
( )
800 –1.000 rpm 6.000 rpm
800 –1.000 rpm 6.000 rpm
800 –1.000 rpm 6.000 rpm
800 –1.000 rpm 6.000 rpm
800 –1.000 rpm 6.000 rpm
800 –1.000 rpm 6.000 rpm
800 –1.000 rpm 6.000 rpm
- Immerse the drills in disinfecting solution immediately after the operation
- Use brushes with metal or nylon bristles for pre-cleaning.
- Disinfect the drills with disinfecting and cleaning agents for rotary instruments. For recommendations for use
(immersion time, concentration, suitability) of the disinfecting and cleaning agents please refer to the
instructions provided by the manufacturer of the agents used.
Disinfecting and cleaning agents must be rinsed off thoroughly with water and the instruments must be dried
carefully (e.g. by air stream). Do not store instruments for a longer period in wet or humid condition. The drills
must not come in contact with each other during the cleaning in the ultrasonic bath. Carry out a visual
inspection of the cleaned instruments. Damaged or blunt instruments must be rejected and their use
discontinued. The same applies to instruments that were subjected to sudden stress (for example by getting
dropped off the table or similar). Do not reuse these instruments, due to increased risk of fracture! Never use
the instrument as a lever! Sterilization of the instruments is carried out using the known methods in an autoclave
at 134°C, according to USP (U.S. Pharmacopeia). The instructions provided by the device manufacturer have to
be observed. After sterilization, check instruments for damage to the surface (increased risk of fracture). The
operator of medical products is responsible for ensuring that proper treatment is carried out by qualified
personnel using the appropriate materials and suited equipment.
6. Safety and liability
Due to cutting on hard bone substance premature dulling of the blades may occur. Therefore, after each use the
burs have to be checked for dull blades or damage and, if necessary, have to be exchanged.
Attention:Risk of accident due to sharp blades of the trepan bur!Risk of accident due to leverage or slipping of
the trepan bur!
See also "Instructions for use and safety recommendations" in the Komet USA LLC catalog.
It is the responsibility of the user to check the products prior to use to ensure that they are suited for the
intended purpose. The user is responsible for the application of the instruments. The manufacturer declines any
liability for possible damage caused in connection with the use of this instrument.
7. Disclaimer of Warranties
ALL WARRANTIES, WHETHER EXPRESS OR IMPLIED, INCLUDING, WITHOUT ALL WARRANTIES, WHETHER
EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, THE IMPLIED WARRANTIES OF MERCHANTABILITY
AND FITNESS FOR A PARTICULAR PURPOSE, ARE EXPRESSLY DISCLAIMED. ALL INCIDENTAL OR
CONSEQUENTIAL DAMAGES, INCLUDING, BUT NOT LIMITED TO, LOST PROFITS, INJURY TO OTHER PROPERTY,
LOSS OF USE OR OTHER COMMERCIAL LOSSES, ARE EXPRESSLY DISCLAIMED. If, not withstanding the
foregoing, consequential and incidental damages cannot be excluded due to operation of law, such damages are
expressly limited in amount to the purchase price of any defective products.
Store out of children's reach.
For dental use only.
The product has been developed solely for use in dentistry. The user is responsible for testing the material for its
suitability and use for any purpose not explicity stated in the instructions. Descriptions and data constitute no
warranty of attributes and are not binding.
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