General Safety Information - Anthogyr 10400X Instrucciones De Uso

The following situations:
• Inappropriate use,
• Lack of maintenance,
• Use of removable accessories or parts not approved by Anthogyr,
• Using accessories from other devices on this MD,
• Change or addition to a MD not validated by Anthogyr.
Relieve Anthogyr of all guarantee obligations or other claims.
These MDs comply with the Community Directive 93/42/CEE as amended by
the 2007/47/CEE directive.
III.GENERAL SAFETY INFORMATION
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Prior to use, check that the device has not been damaged in any way
and that no parts are missing.
Wear appropriate protection, especially gloves, a mask and glasses.
Do not use the MD and inform your distributor or Anthogyr After-Sales (AS)
in the following situations :
• visible failure or damage,
• non-existent or insufficient irrigation (at least 50 ml/min, correctly
tempered and oriented in an optimum manner),
• scratch or damage to the emitting side of the LED.
Risk of damage to the device and injury, wait until the motor has completely
stopped to:
• connect/disconnect the MD from the motor,
• turn the assembly/disassembly system on,
• turn the locking/unlocking system for the rotary instrument on,
• handle the rotary instrument.
Assess the risk of septic substances penetrating tissue if used with a central
air cooling motor (refer to the motor manufacturer's leaflet).
Warning : this MD has a ball bearing system.
The power is maintained :
• For motors having a torque calibration system (like the IMPLANTEO
must calibrate the contra-angle as directed by the manufacturer. The motor
must have been calibrated for the used contra-angle.
• For any other motors: make sure that the displayed torque values are
right.
A tapping or a screwing torque which is too high (above 35N.cm) may
increase risks of necrosis or of bone fissuring. Furthermore, the implant
and the instrument may be damaged: implant manufacturer's prescriptions
have to be respected.
Risk of burning and injury :
• Apply pressure to the MD with a rotary instrument (refer to the
manufacturer's instructions) without exceeding 2N (about 200g).
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