Komet CeraBur Instructions For Use

Manufacturer:
Gebr. Brasseler GmbH & Co. KG
Trophagener Weg 25
32657 Lemgo · Germany
CeraBur
®
© 08/2012, Gebr. Brasseler GmbH & Co. KG
304892 - Rev 08/2012
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¿ Order number
Numéro d'ordre
Número de pedido
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Oral surgery
Chirurgie maxillo-faciale
Oral surgery
Ceramic · Céramique · Cerámica
( 3.000 - 6.000 rpm
K160A
40.000 rpm
)
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CeraBur – Ceramic bone cutter
®
Komet "CeraBur " are designed, constructed and produced with utmost care. These quality instruments
®
guarantee excellent results and a long service life, provided that they are used in the proper manner. The
following instructions for use and safety recommendations therefore have to be observed.
1. Indication
The present bone cutter is suitable for a wide range of uses in dental alveolar surgery, e.g. for the restoration of
edentulous ridges when removing sharp bone edges, for the extraction of bones for example from the chin or
from the retromolar zone for autogenous bone transplantation, for osteotomy when exposing impacted teeth and
for the treatment of root apexes as surgical measure for the conservation of teeth.
2. Contraindication
Surgical treatments which may lead to jamming of the instruments, as this entails an increased risk of instrument
breakage.
3. Clinical sequence
- Select the required size of the bone cutter
- Determine the size and the exact position of the operation site with the help of radiographs (e.g. bitewing
radiograph, orthopantomogramme or dental film)
- Examine the adjacent structures
- In order to prevent any danger to adjacent structures, carefully check the area surrounding the operation site
- Administer a local anaesthesia to the operation site/jawbone
- Cut the mucosa and periost to the bone and expose the preparation site
- Apply the bone cutter at the chosen position
- Cutting should be carried out exerting low pressure and using constant exterior cooling with sterile
physiological saline solution to prevent thermal damage to the bone tissue and to ensure proper chip removal
Make sure that the cutter neither jams nor gets stuck during use (increased risk of fracture). Prepare at a speed
of 3.000 - 6.000 rpm. The indicated speed should be observed in order to avoid fracture of the instrument.
4. Further treatment
- Prepare the operation site according to the established methods.
5. Recommendations for maintenance
The burs are supplied in non-sterile condition. Prior to first use, the burs must therefore be cleaned, disinfected
and sterilized. Do not allow residues from the operation (blood, secretions, tissue) to dry. Immerse the burs in
disinfecting solution immediately after the operation. Disinfect the burs 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 manufacturers' instructions. Only use brushes with metal-free bristles for
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
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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
pre-cleaning, as these do not leave discolorations caused by abrasion on the instruments. Disinfecting and
cleaning agents must be rinsed off thoroughly with water and the instruments must be dried carefully (e.g. by
airstream). Do not store instruments in wet or damp condition for a longer period of time. The burs should not be
allowed to come in contact with each other during the cleaning in the ultrasonic bath. Examine the cleaned
instruments visually. Damaged or dull instrument 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 continue using these instruments, as there is an increased risk of breakage!
Sterilization is carried out in the autoclave following the usual methods. The instructions provided by the device
manufacturer have to be observed. After sterilization, the instruments have to be examined for surface damages
(cracks). Discontinue the use of damaged instruments (increased risk of breakage).
6. Safety and liability
Due to the cutting of hard bone material and tooth substance premature blunting of the blades may occur.
Therefore, the burs have to be checked for blunt blades or other damages after each use. Exchange if necessary.
Be sure to observe the indicated speed in order to avoid instrument breakage.
Attention: Risk of injury caused by the sharp blades of the bur! Risk of injury due to jamming and slipping of the
bur!
See also "Instructions for use and safety recommendations" in the KOMET USA LLC catalog.
Prior to application, the user undertakes to check whether the product is suited for the intended use. The user is
responsible for the application of the bur. 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 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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