D-0123234-D – 2020/05
Affinity Compact - Instructions for Use - EN Page 51
3.4.1 HIT440 Software - Technical Specifications
The CE-mark indicates that Interacoustics A/S meets the
requirements of Annex II of the Medical Device Directive
93/42/EEC.
Approval of the quality system is made by TÜV – identification no.
Hearing aid analyzer
standards:
IEC 60118-0:2015, IEC 60118-7:2005, ANSI S3.22:2014
1/3, 1/6, 1/12 and 1/24 octave or 1024-point FFT.
Stimuli
Pure tone
Narrow band noise
Random noise
Pseudo random noise
Pink noise
White noise band limited
Speech noise
ICRA
Real speech
IFFM
IF Noise
/SS/
/SH/
Custom sound files (automatic
FFT:
Resolution 1024 points.
Averaging: 1sec – 1200sec.
Stimulati intensity range:
40-100 dB SPL in 1 dB step.
Intensity accuracy:
200Hz - 8000Hz: < ± 1.5 dB
8000Hz – 16000Hz: < ± 5 dB
Measurement intensity
range:
100Hz – 200Hz: 40-145 dB SPL ± 3 dB
200Hz - 8000Hz: 40-145 dB SPL ± 1.5 dB
8000Hz – 16000Hz: 40-145 dB SPL ± 5 dB
Stimulus distortion:
70 dB SPL: < 0.5%THD
90 dB SPL: < 2 % THD
Battery voltage accuracy:
Battery current accuracy:
Standard and custom types are selectable