D-0004578-R – 2022/05 Page 41
Affinity2.0/Equinox2.0 - Instructions for Use - US
3.3.1 REM440 software - technical specifications
The CE-mark in combination with MD symbol indicates that
Interacoustics A/S meets the requirements of the Medical Device
Regulation (EU) 2017/745 Annex I
Approval of the quality system is made by TÜV – identification no. 0123.
Real Ear Measurement
standards:
IEC 61669 2015, ANSI S3.46 2013
Warble Tone, Pure Tone, Random noise, Pseudo random noise, Band
limited white noise, Chirp, ICRA, Real Speech, any other sound file
(automatic calibration available).
Measurement intensity range:
Probe microphone 40-145 dB SPL ± 2 dB.
1/3, 1/6, 1/12, 1/24 octave or 1024-point FFT.
Cross talk in the probe and probe tube will alter the obtained results with
less than 1 dB at all frequencies.
REUG
REIG
RECD
REAR
REAG
Input – Output
FM Transparency
Ear Level, FM only
Directionality
Visible speech mapping
Noah 4, OtoAccess® and XML compatible