Komet MaxilloPrep Bone TRC Instructions For Use

Manufacturer:
Gebr. Brasseler GmbH & Co. KG
Trophagener Weg 25
32657 Lemgo · Germany
MaxilloPrep Bone
© 08/2012, Gebr. Brasseler GmbH & Co. KG
306089 - Rev 08/2012
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¿ Order number
Numéro d'ordre
Número de pedido
Oral surgery
Chirurgie maxillo-faciale
Oral surgery
Centering burs · Fraises de centrage · Fresas de centrado
( 800 - 1.000 rpm
TRC.205.045 6.000 rpm
)
Trepan burs · Trépans · Trépanos
( 800 - 1.000 rpm
TRT.205.045
6.000 rpm
)
Bone chip extractors · Fraises pour le prélèvement des copeaux osseu · Extractores de fragmentos óseos
500 rpm
(
9126.204.042 15.000 rpm
)
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Trepan bur and bone chip extractor for the extraction of bones as developed by Dr. Neumeyer, Germany

1. Indication

For the extraction of bone cylinders and bone chips from suitable donating areas in the oral cavity.

2. Contra-indication

Risk to anatomic structures in vicinity of the bone extraction site. Make sure to observe a clearance distance of
3 mm. Ensure that the stability of the extraction site is not at risk.
This applies particularly to the lower jaw.

3. Clinical sequence/proper use

Select the correct size of the bur and determine the drilling depth, if required.
- Determine the size and the drilling depth by means of radiographs (i.e. bite-wing photograph and
orthopantomogramme, DVT and CT).
- In case of major extractions, a computer tomographic examination is recommended in addition to the bite-
wing photograph and the orthopantomogramme.
Examination of the adjacent structures
- To exclude any danger to adjacent structures such as the root of the tooth, the floor of the mouth, the
maxillary antrum or nerve canals, examine the area surrounding the extraction site carefully.
Administer a local anaesthetic to the site where the bone is to be extracted
- Cut the mucosa and the periosteum to the bone and expose the extraction site
Avoid any risk of injury!
- A sure way of preventing injuries is to place a wound retractor or another suitable instrument, such as a
raspatory.

3.1 Use of the centring bur and the trepan bur

- Once the extraction site has been exposed, apply the centring bur to the bone at the predetermined site,
making sure to avoid injury to the surrounding soft tissue. Note: When applying the centring bur, make sure that
the tip of the bur is securely anchored in the bone in order to avoid jamming of the bur during use.
- Drill until you have created a guide groove with a depth of between 1 and 2 mm.
- Then place the teeth of the trepan bur in the previously prepared guide groove. Do not switch on the dental
drive system until the trepan bur is positioned in the guide groove.
- Drilling takes place in axial direction until the desired depth has been reached. Exert little pressure while
drilling. Make sure to keep soft tissues away from the trepan bur to prevent the perforations of the trepan bur
from inadvertently gripping the soft tissue.

3.2 Use of the bone chip extractor

- Once the extraction site has been exposed, apply the bone chip extractor to the bone
at the predetermined site, making sure to avoid injury to the surrounding soft tissue.
- Drilling takes place in axial direction, exerting little pressure. Drill until the required quantity of bone chips has
been removed from the jaw bone (see point 4.2).

3.3 Drilling procedure

- Drill in intermittent mode, providing constant external cooling with a physiological saline solution.
The external irrigation prevents thermal damage to the bone tissue.
- Drilling takes place with low pressure until the desired depth is reached. Speed: 500 rpm (green contra-angle,
minimum reduction 10 : 1). Note: This type of operation has to be carried out under absolutely sterile conditions.
An infection of the bone marrow can lead to serious damage to the patient's health.

4. Further treatment

4.1 Extraction of the bone cylinder (trepan bur)

Once the bone transplant has been loosened,
- it can be removed with tweezers by either gently turning or shaking the tweezers
If the bone transplant remains in the trepan bur,
- it can be pushed out with tweezers through the perforations of the trepan bur
If the bone transplant is still firmly attached
- it can be loosed from its basis by means of a small raspatory or a papilla elevator and then removed with
tweezers.
- The bone cylinder can be cut into smaller pieces with a suitable instrument, if required
- Ensure that there is absolutely no bleeding at the donating site. Fill with artificial bone material if necessary.
- The wound must be surgically treated and sealed against saliva. Put the periosteum above the extraction site
back into place.

4.2 Removal/collection of bone chips (bone chip extractor)

- The bone chips can be removed and collected with tweezers. Alternatively, the bone chips can also be
collected with a commercially available bone filter system.
- Ensure that there is absolutely no bleeding at the donating site. Fill with artificial bone material if necessary.
- The wound must be surgically treated and sealed against saliva. Put the periosteum above the extraction site
back into place.
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
( 800 - 1.000 rpm
TRC.205.055 6.000 rpm
)
( 800 - 1.000 rpm
TRT.205.055
6.000 rpm
)
Instructions for use
Please read carefully and retain for future reference.
Conseils d'utilisation
A respecter scrupuleusement et garder cette copie
pour une utilisation ultérieure.
Instrucciones de empleo
Leer detenidamente y guardar este ejemplar para
uso más tarde.
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Consult instructions for use
Se reporter aux instructions
Observe indicaciones
( 800 - 1.000 rpm
TRC.205.065 6.000 rpm
)
( 800 - 1.000 rpm
TRT.205.065
6.000 rpm
)
500 rpm
(
9126.204.060 10.000 rpm
)

5. Recommendations for maintenance

All components of the system have to be cleaned manually first, followed by disinfection in the ultrasonic device
with anticorrosive disinfecting and cleaning agents for rotary instruments (e.g. Komet DC1). Observe the
manufacturer's recommendations regarding immersion time, concentration and suitability of the disinfecting
and cleaning agents. Rinse off any trace of disinfecting and cleaning agents with water and dry the instruments
thoroughly (e.g. by air stream). Do not store instruments for a longer period in wet or humid condition. The
instruments must not come in contact with each other during the cleaning in the ultrasonic bath. Examine the
cleaned system components visually. Damaged components and/or blunt instruments must be rejected and
their use discontinued. Sterilization of the instruments takes place in the autoclave at 134°C. The instructions
provided by the device manufacturer have to be observed. Do not reuse corroded components. The operator of
medical products is responsible for ensuring that reprocessing is carried out by qualified personnel using the
appropriate materials and suited equipment. Work instructions with regard to proper reprocessing of
instruments according to DIN EN ISO 17664 (medical devices – instruments with internal cooling – standardised
manual reprocessing) can be downloaded from our web site www.kometusa.com or requested from the
manufacturer Gebr. Brasseler.

6. Safety and liability

Discard any worn or damaged system components and replace with new ones. It is absolutely essential that the
above mentioned instructions for handling and cooling of the instruments be observed. The system components
may only be used for the indicated purpose. Non-observance of the safety recommendations can lead to
damage to the power systems or injury. It is the responsibility of the user to check the products prior to use to
ensure that they are suited for the intended purpose. See also the instructions for use and safety
recommendations in our current dental catalogue and the general information provided on our website
www.kometusa.com. In case of contributory negligence by the user, Gebr. Brasseler partially or totally declines
liability for all resulting damages, particularly due to non-observance of our recommendations for use or
warnings as well as inadvertent misuse by the user.
Warnings: Improper use can lead to damage to the tissue, premature wear, destruction of the instruments and
injury to the operator, patient or third parties.
Cooling!
When using rotary instruments without internal cooling, suffi cient external cooling has to be supplied, otherwise
the instrument blades will get clogged with chips, which leads to increased heat generation and at worst to
irreversible damage to the bone (thermal necrosis). This will also greatly reduce the service life of the
instruments.
Attention: Risk of injury caused by the sharp blades of the drill! Risk of injury due to jamming and slipping of the
drill!
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 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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Stainless Steel
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Stainless Steel
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Stainless Steel
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