Device Handling And Operation; Measurement Safety; 8-Technical Data - Resonance R07A Benutzerhandbuch

7.2 Device handling and operation

The device should be checked once daily, as per operations described on paragraph 6.
The device is designed to be handled and operated by trained personnel like Audiologist, ENT doctors
or personnel with similar qualifications ONLY.

7.3 Measurement Safety

As a manufacturer, we recommend to perform an annual inspection and calibration in order to ensure
safety and quality of the measurement.
The annual check-up can be performed only by RESONANCE distributor or authorised service center.
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 audiometer is strictly prohibited.
Reference standard:
Safety:
EMC:
Medical CE Marks:
Inputs:
Outputs:
Attenuator:
Tone presentation:
Talk Forward:
Auto Threshold:
Store function:
Modulation:
46
EN 60645-1/ANSI S3.6, Type 4
EN 60601-1
EN 60601-1-2
The Manufacturer's Quality Management System complies to the Annex
II of Medical Device Directive 93/42/EEC. The notification body IMQ,
Identification No. 0051, has approved the Quality System.
Medical approved Power supply; Patient pushbutton
AC Left and Right
-10 to 100 dB HL in 1, 2 or 5 dB steps
Manual or Reverse (selected in Setup menu); Pulsed at 0.5, 1, 2 Hz (select-
ed in Setup menu); Manual On/Off; Pure tone or Warble
Built-in talk forward microphone 50 - 100 dB SPL adjustable
Patient controlled Hughson Westlake procedure according to ISO 8253-1
Soft key store button and internal memory for 50 patients and related
tests results. Stored measurements can be viewed on the build in display.
Warble +/- 5% 5 Hz.
8. Technical data