Komet SF1 Iinstrucciones De Empleo

Manufacturer:
Gebr. Brasseler GmbH & Co. KG
Trophagener Weg 25
32657 Lemgo · Germany
Sonic tips for prophylactic treatment
© 08/2012, Gebr. Brasseler GmbH & Co. KG
307218 - Rev 08/2012
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Numéro d'ordre
Número de pedido
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Prophylaxis
Prophylaxie
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Sonic tips for prophylactic treatment
1. Safety Notice
Please read the instructions for use prior to using sonic tips for prophylactic treatment. Sonic tips may only be
used for their intended purpose according to the general rules for dental treatment, occupational safety and
accident prevention. Sonic tips should only be used if they are in excellent condition. If the indication and use
are unclear, treatment should be suspended until these points have been clarified. These sonic tips should only
be used by qualified personnel with training and experience in prophylactic treatments and the use of sonic tips.
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 these instruments. 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 explicitly stated in the instructions.
Descriptions and data constitute no warranty of attributes and are not binding.
2. Product description
The Komet Sonic tips are designed for oscillating work on teeth within a prophylactic treatment.
3. Indication for use
Used for sub- and supragingival scaling of calculus. Suited for pockets with a depth of up to 2 mm.
4. Applications
The sonic tips SF1, SF2 and SF3 shall be used in combination with the KOMET sonic handpiece SF1LM for
prophylactic treatments.
5. Contraindications
There are no known contraindications.
6. Warnings
The tips are supplied in non-sterile condition. Therefore they must be sterilized prior to the first use on the
patient and immediately after each use. The useful life of the sonic tips is limited. They therefore have to be
used with utmost care. The sonic tips may only be used by dentists and medical personnel sufficiently trained in
the relevant fields of prophylactic treatment. Premature wear! Due to the nature of their range of application,
the functional parts of these sonic tips will always be subject to moderate wear, even when the tips are applied
correctly and according to their intended use. The extent of wear can be determined with the test card
(405444). Excessively worn tips have to be exchanged. Improper use can lead to damage to the tissue,
premature wear, destruction of the instruments and injury to the operator, patient or third parties. Avoid
excessive contact pressure! This can lead to damage to the instruments' working part. At the same time,
extreme heat is generated which increases the risk of thermal necrosis. At worst, breakage of the instrument
can occur if too high contact pressure is applied. Optimal results are achieved at a contact pressure of max.
2.5 N. This can be compared with the pressure which is applied when writing with a fountain pen. Avoid
jamming of the instrument during treatment! Do not use as a lever! Since the sonic tips may fracture without
warning even when used in accordance with their intended use, two sonic tips should always be planned for the
treatment, i.e. one should remain at hand as a reserve so that the planned treatment can still be completed if
one tip has broken. Caution: To avoid injury and infection, wear gloves or finger protection when inserting or
removing the sonic tips from the sonic handpiece. Damaged and deformed instruments cause vibrations and
lead to rough surfaces and damage to the hard dental substance. Very important: Damaged instruments lead to
the user applying higher contact pressure which may result in an increased operating temperature. This may
lead to thermal damage. Damaged instruments therefore have to be discarded immediately.
Safety check:
Fracturing may occur due to the tips being subjected to continuous or sudden stress (for example, if the tips are
dropped on the floor or if the original shape is changed mechanically). Instruments with the following defects
must be discarded:
- Damaged surface
- Deformation (warping, twisting, fracture)
- Surface corrosion
7. Cooling
It is absolutely essential to thoroughly and continuously irrigate the site at all times during the operation.
To this end, at least 50 ml/min of a suitable cooling agent has to be supplied by the dental treatment unit.
8. Precautions/recommendations for maintenance
Important note: Never use the instruments as a lever! It is extremely important to handle all tips with care.
Damage to their surface considerably impairs the performance of these instruments!
The tips are supplied in non-sterile condition. Therefore they have to be disinfected, cleaned and sterilized prior
to first use.
- Do not allow residues from the treatment (blood, secretions, tissue) to dry
- Place sonic tips in a cleaning/disinfection tank filled with suitable detergent/disinfectant immediately after
use in the mouth to prevent drying of residues on the instruments (protein fixation)
- Only use brushes with nylon bristles for pre-cleaning
- Disinfect the sonic tips 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.
Manual pre-cleaning (prior to mechanical and manual reprocessing):
1. Remove sonic tip from cleaning /disinfection tank immediately before reprocessing.
2. Check patency of the cooling passage by guiding the nozzle cleaner through the passage. Replace instrument
if the passage is obstructed.
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
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
Mechanical reprocessing (validated):
1. Rinse sonic tip thoroughly under running water to prevent any residues of the detergent/disinfectant from
getting into the washer/disinfector.
2. Unscrew the nozzle on the injector bar of the washer/disinfector. Then screw the external thread of the rinse
adapter SF1978 in the silicon holders on the injector bar. Now screw the sonic tip in the internal thread at the
top of the rinse adapter (fig. 1). Observe the directions in the instructions for use provided with the SF1978.
3. Put chemical detergent (mild alkaline cleaning agent e.g. Neodisher FA) into the washer/disinfector, following
the indications on the label and the instructions of the manufacturer of the washer/disinfector.
4. Start the Vario TD programme including thermal disinfection. Thermal disinfection takes place allowing for
the A value and observing national provisions.
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5. On completion of the cycle remove sonic tip from the washer/disinfector and dry (preferably with
compressed air). When drying the inside of the instruments, please make sure to hold the compressed air gun
close to the cooling passage, in order to guarantee that sufficient air flows through the sonic tip.
6. Visual examination to ensure that the instrument is clean and undamaged. If after mechanical reprocessing
there are still visible residues of contamination, repeat the cleaning and disinfecting process until no visible
contamination is left.
Manual reprocessing (alternative):
1. Place sonic tip onto a 10ml syringe and rinse with detergent/disinfectant. In case of visible contamination
emerging from the perforations, rinse again with detergent/disinfectant.
2. Remove stubborn contamination with a nylon brush under running water, turning the sonic tip constantly.
3. Rinse sonic tip thoroughly with running water.
4. Visual examination to ensure that the instrument is clean. If there are still visible residues of contamination,
repeat the cleaning process until no visible contamination is left.
5. Place sonic tip in a suitable container into the ultra sonic device or instrument bath filled with detergent/
disinfectant.
6. During chemical disinfection in the ultrasonic device or instrument bath, observe the instructions of the
manufacturer regarding concentration and immersion time. Be sure to observe the full correct immersion time
which does not start until the last tip has been immersed. Attention: do not exceed 45°C (risk of protein
coagulation)!
7. On completion of the immersion time, rinse sonic tip thoroughly with suitable water (preferably with
demineralised water to avoid residues of lime). Rinse the perforation of the sonic tip with at least 10 ml of
demineralised water by means of a cannula, to ensure that no residues of the detergent are left in the cooling
passage.
8. Dry sonic tip (preferably with compressed air). When drying the inside of the instruments, please make sure
to hold the compressed air gun close to the cooling passage, in order to guarantee that sufficient air flows
through the sonic tip.
9. Visual examination to ensure that the instrument is clean and undamaged. If there are still visible residues of
contamination, repeat the cleaning and chemical disinfecting process until no visible contamination is left.
Note: mechanical cleaning is preferable.
Sterilisation in the autoclave:
The sonic tips can be steam-sterilized at 134°C in a suitable device using the vacuum process. The sonic tips
must be unscrewed from the rinse adapter before each sterilization cycle. Prior to sterilization, the sonic tips
must be individually packed in sterilization pouches (to prevent contact corrosion). Alternatively, they can be
placed in a suited sterilization cassette (e.g. Komet 9952) that is packed in sterilization pouch. The pouch must
be sufficiently large to comfortably fit the cassette or tip without strain on the packaging. Sterilization is
effected in an autoclave with fractionated pre-vacuum (type B) or simplified pre-vacuum (type S) with a holding
time of at least 5 minutes (full cycle) and a drying time of at least 10 minutes at 134 °C +1. Alternatively,
sterilization may also be effected in an autoclave with gravitation process at 121°C +1 with a holding time of at
least 30 minutes. Note the range of application indicated in the manufacturer's instructions.
9. Use
The sonic tip is screwed into the Komet sonic handpiece SF1LM with the tip changer SF1980, turning in
clockwise direction. To remove the tip, fit the tip changer over the tip and turn anticlockwise to unscrew it.
Particularly in the case of curved tips, care must be taken to ensure that the working parts protrude into the
half-radius of the tip changer in order to avoid injury and contamination. Also observe the instructions in the
directions for use of the sonic hand piece SF1LM. Power level 1 or 2 is the standard level for this indication in
combination with the SF1LM. Power level 3 can be used for short term treatment.
10. Special patient population
Patients must, as a matter of principle, be suitable for prophylactic treatment.
11. Adverse reactions
All known reactions on dental treatment have to be considered carefully which may include but are not limited to:
- Device failure
- Infection
- Tissue damage as a result of the dental treatment
12. 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..
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