Safety Regulations; Electrical Safety; Device Handling And Operation; Measurement Safety - Resonance R16M Mode D'emploi

12. Safety regulations

12.1 Electrical Safety

The device applied parts comply to type BF of IEC 60601-1, in any case, the device is not
intended to be used in environments dealing with explosive material or equipment.

12.2 Device handling and operation

The device should be checked once daily, as per operations described on section 11.
The device is designed to be handled and operated by trained personnel such as Audiologist, ENT
doctors or personnel with similar qualifications ONLY.

12.3 Measurement Safety

As a manufacturer, we recommend to perform an annual inspection and calibration in order to ensure
safety and quality of the measurement.
Annual calibration and maintenance should only be carried out by RESONANCE authorized personnel.
M.R.S. will not be liable for any failure to comply with the specified inspection date, according to the
Medical product law. The use of uncalibrated and uninspected device is strictly prohibited
5. Make sure the 3 channels are completely free from
any kind of debris.
6. Place the transparent probe tip back making sure the
recess on the tip is properly matched with the
corresponding tooth on the front part of the probe.
Please note that in case the tip is inaccurately
positioned, closing the probe is not possible.
7. Place the front part of the probe tip back into place
making sure it is perfectly coupled to its body and
both plastic brackets are hooked.
R16M User's Manual – Page 136