Komet CeraTip Instructions For Use

Manufacturer:
Gebr. Brasseler GmbH & Co. KG
Trophagener Weg 25
32657 Lemgo · Germany
CeraTip™
© 08/2012, Gebr. Brasseler GmbH & Co. KG
305482 - Rev 08/2012
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Numéro d'ordre
Número de pedido
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Oral surgery
Chirurgie maxillo-faciale
Oral surgery
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CeraTip™
1. Indication
Suitable for use in various sectors of mucosa surgery, the tissue trimmer CeraTip™ constitutes an ideal alternative
to electrotomes, curettes and scalpels when it comes to treating the gingiva. Possible applications:
- Modelling and conservative reaming of the gingiva, even in hard–to–reach areas
- Exposing intra–osseous implant sites
- Exposing impacted teeth
- Exposing deep cavities in the neck of the tooth
- Papillectomy/Removal of hyperplastic gingiva
- Dilation of the sulcus following a crown core preparation
2. Contraindication
- Any type of treatment that may cause jamming of the instrument.
3. Clinical sequence/appropriate use
- Establish the exact position of the site of the treatment.
- In order to prevent any danger to adjacent structures, carefully check the area surrounding the treatment site.
- Anaesthetise the site where the instrument is to operate/jaw bone, if required.
- Clean and dry the site prior to the treatment. Remove all residues such as blood, secretions and tissue and dry
the area by air stream.
- Apply the tip of the CeraTip™ at the required position and model the tissue by carrying out gentle, consistent
movements.
- The tissue can be modelled without hardly any bleeding thanks to the thermal coagulation caused by the
rotational energy of the CeraTip™.
- Prepare in the turbine without cooling up to the desired position, exerting little pressure and observing a speed
of 300.000 – 450.000 rpm. Make sure to stick to the indicated speed to avoid fracture of the instrument. Use
tissue trimmer in intermittent mode.
4. Cleaning, disinfection and sterilization
Only use brushes with metal-free bristles for pre-cleaning (9873). 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
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.
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Instructions for use
Please read carefully and retain for future reference.
Conseils d'utilisation
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Instrucciones de empleo
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Consult instructions for use
Se reporter aux instructions
Observe indicaciones
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 instruments must not come in contact with each other during the cleaning in the ultrasonic
bath. Carry out a visual control of the 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, as there is an increased risk of fracture! Never
use the instrument as a lever! Sterilization of the instruments is carried out using the known methods with
autoclave. Minimum hold times: for 30 minutes at 121°C or for 4 minutes at 134°C. The above indicated times
are hold times only, running times are longer and may vary from unit to unit. 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 appropriate materials and suited equipment.
5. Safety and liability
The user is responsible for the application of the instruments. In case of contributory negligence by the user, the
manufacturer 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.
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.
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.
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