Komet H254 Series Instructions For Use

Manufacturer:
Gebr. Brasseler GmbH & Co. KG
Trophagener Weg 25
32657 Lemgo · Germany
H254E – H254LE
© 09/2015, Gebr. Brasseler GmbH & Co. KG
304971 - Rev 09/2015
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¿ Order number
Numéro d'ordre
Número de pedido
Oral surgery
Chirurgie maxillo-faciale
Oral surgery
80,000 rpm
(
H254E.FG.012 160,000 rpm
)
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Tungsten carbide instrument H254E/H254LE
1. Indication
- Minimally invasive combination instrument for conservative preparation of bone tissue and hard tooth
substance
- Removal of impacted wisdom teeth
- Apical ectomy
The instrument is used for tissue-friendly pre pa ra tion of bone or bone lids which can be repositioned after
removal of impacted wisdom teeth or after apical ectomy and for definite removal of surrounding bone tissue.
Due to its efficient cutt ing ability the instrument is also suited for cutt ing hard tooth substance, in particular for
separating tooth roots.
2. Contraindication
- Treatments where the instrument is used as a lever (e.g. for loosening and removing of pre pared bone or
wisdom teeth)
- Not suited for cutting root posts
- Insufficient external cooling (less than 50 ml/min)
3. Proper use
For removal of impacted wisdom teeth or apical ectomy and for treatment of bone surfaces
- Expose the jaw bone according to the known procedure
- Prepare the contour of the bone transplant with the combination instrument considering its shape and position
or re duce the sur round ing bone, applying sufficient external cooling (at least 50 ml/min.). For axial pre paration,
move the instrument circularly in order to avoid jamming. On one hand the external cooling prevents the bone
tissue from being exces sively heated and on the other hand it facilitates evacuation and rins ing of bone chips.
- The preparation is carried out with low contact pressure (≤ 2N) to the required depth. Care should be taken
that the cutting surfaces are sufficiently exposed to coolant.
- Use suction to remove bone chips and lift the loosened bone transplant with tweezers.
- Separate tooth or root with the combination instrument; with sufficient external coolant, at least 50 ml/min)
and remove the fragments, for instance with forceps or tweezers.
- Treat the wound according to the generally practised procedure and if indicated reposition the bone transplant
and close the mucosa.
Note: The instrument shall not be used as a lever - risk of accident. The H254E.FG/H254LE.FG is designed to be
used in the micromotor (red contra-angle) and not in the turbine.
4. Recommendation 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
- Immerse the drills in disinfecting solution immediately after the operation
- Use brushes with metal or nylon bristles for pre-cleaning.
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
80,000 rpm
(
H254LE.FG.012 100,000 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
40,000 rpm
(
H254E.HP.012 100,000 rpm
)
- 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 manu facturer of the agents used.
Disinfecting and cleaning agents must be rinsed off thoroughly with water and the in struments 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.
5. Safety and liability
Worn and damaged instruments must be rejected immediately and replaced by new ones. The instructions for
handling, cooling and contact pres sure have to be strictly observed. The in stru ments should only be used for the
indi cated purpose. Non-observance of these safety instructions may lead to damage of the handpiece or injuries.
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.
6. 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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