Intended Use; Indications For Use - W&H Osstell Beacon User Manual

The SmartPegs are disposable and should only be used for one
or multiple measurements at one treatment session, for a single
patient only (to avoid cross-contamination). Repeated re-use may
result in false readings due to wear and tear of the soft aluminum
SmartPeg threads. Do not use if the product sterile barrier system
or its packaging is compromised.
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.
Always charge the instrument, using the supplied Osstell USB-ca-
ble, directly connected to a 5 Volt USB type A port.
Splitter cables must never be used as these can lead to
permanent damage to the device.
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 com-
patible 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.
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25087-03 GB