Introduction; Warnings And Precautions; Intended Use; Indications For Use - W&H Osstell IDX Manual De Instrucciones

1) Introduction

Qualifications of the user
This medical device is intended to be used by qualified dentists, doctors, surgeons, or specialist staff appointed
by the responsible clinician.
Responsibilities of the user
Read through the entire instructions for use before using this device.
Observe the Warnings and Precautions.
Any serious incident that has occurred in relation to the medical device should be reported to the manufacturer
and the competent authority!
Responsibility of the manufacturer
The manufacturer can only accept responsibility for the safety, reliability and performance of the medical device
when compliance with the following instructions is ensured:
• The medical device must be used in accordance with these instructions for use.
• Modifications or repairs may only be undertaken by Osstell.
• Unauthorized opening of the unit invalidates all claims under warranty and any other claims.
In addition to unauthorized disassembly, modification or repair of the unit and non-compliance with these
instructions for use, improper use will void the warranty and release Osstell from all other claims.

2) Warnings and Precautions

Warnings
The Probe emits an alternating magnetic field that potentially could interfere with cardiac pacemakers! Keep
the probe away from implanted electronic devices. Do not place the probe on the patient's body.
Use only the power supply provided with the instrument.
The SmartPegs are disposable and should only be used for one or multiple measurements at one treat-
ment 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 aluminium SmartPeg threads. Do not use if the product sterile
barrier system or its packaging is compromised.
The Osstell ISQ Probe and the SmartPeg Mount must be sterilized before use.
Precautions
Do not use the device in the presence of explosive or flammable materials.
To avoid interference with other equipment, the probe should not be held close to electronic devices.
To remove the probe from the instrument, pull gently holding around the probe connector.
Do not pull the cable and do not twist the connector.

3) Intended Use

Osstell IDx is intended for use as a Dental Implant Stability Analyzer.
4) Indication for Use
Osstell IDx is indicated for use in measuring the stability of implants in the oral cavity and maxillofacial region.
Conditions
Surgically placed implants or abutments for which there is space to attach a compatible SmartPeg.
Reasons for use
The Osstell IDx 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.
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