Osstell Beacon, Руководство пользователя

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25087-00 ML
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Do not expose the instrument to extreme high temp, e.g. leaving
it in the car dashboard on a warm sunny day.
The Osstell Beacon is not protected from ingress of fluids, e.g.
water, at the USB connector (IP20 classified).
Mains-operated power supplies or USB cable used for charging,
shall not be reachable by the patient.
Precautions:
To avoid interference with other equipment, the instrument
should not be held close to electronic devices.
Only use the acceptable cleaning fluids listed in section 15
when cleaning the instrument.
Do not use the instrument in the presence of explosive or
flammable materials.
See section 4, 5 and 10 for information about approved and
compatible accessories.
3) Intended Use
Osstell Beacon is intended for use as a Dental Implant Stability
Analyzer.
4) Indication for use
Osstell Beacon is indicated for use in measuring the stability of
implants in the oral cavity and craniofacial region.
Conditions
Surgically placed implants or abutments for which there is space
to attach a compatible SmartPeg.
Reasons for use
The Osstell Beacon can add important information to the evaluation
of implant stability and can be used as part of an overall treatment
evaluation program. The final implant treatment decisions are the
responsibility of the clinician.
Contraindications
Osstell Beacon is contraindicated for implant systems to which the
SmartPeg could not be attached for mechanical incompatibility
reasons. See section 10 for more information about SmartPegs.
Osstell Beacon is contraindicated when used together with Pegs not
approved by Osstell. Osstell Beacon is contraindicated where it is
not possible to attach the SmartPeg due to lack of space, or where it
impinges on other artificial or anatomical structures.
5) Description
The Osstell Beacon is a handheld instrument that involves the use
of the non-invasive technique, Resonance Frequency Analysis.
The system involves the use of a SmartPeg attached to the dental
implant or abutment by means of an integrated screw. The Smart-
Peg is excited by a magnetic pulse from the instrument tip.
The resonance frequency, which is the measure of implant stability,
is calculated from the response signal. Results are displayed on the
instrument as the Implant Stability Quotient (ISQ). The ISQ is scaled
from 1 to 100. It is a measurement of the stability of the implant
and is derived from the resonance frequency value obtained from
the SmartPeg. The higher the number, the greater the stability. The
instrument software can be updated by using the Osstell USB cable.