Interacoustics Affinity Compact - Technical Specifications of the AC440 Software

D-0123234-D – 2020/05
Affinity Compact - Instructions for Use - EN Page 37
3.2.4 Technical specifications of the AC440 Software
Medical CE-mark:
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. 0123.
Audiometer standards:
Tone: IEC60645-1:2017/ANSI S3.6:2018 Type 1
Speech: IEC60645-1:2017/ANSI S3.6:2018 Type A or A-E
Transducers & calibration:
Calibration information and instructions are located in the Service
manual.
Check the accompanying Appendix for RETSPL levels for transducers
Air Conduction
DD45
ISO 389-1 2017, ANSI S3.6-2018 Headband Static Force 4.5N
±
0.5N
TDH39
ISO 389-1 2017, ANSI S3.6-2018 Headband Static Force 4.5N ±0.5N
DD65 v2
PTB 1.61-4091606/18, AAU 2018 Headband Static Force 11.5N±0.5N
HDA300
PTB report 1.61.4066893/13 Headband Static Force 8,8N ±0.5N
DD450
ISO 389-8 2004, ANSI S3.6-2018 Headband Static Force 10N ±0.5N
E.A.R Tone 3A
ISO 389-2 1998, ANSI S3.6-2018
IP30
ISO 389-2 1998, ANSI S3.6-2018
Bone Conduction
Placement: Mastoid
B71
B81
ISO 389-3 2016, ANSI S3.6-2018 Headband Static Force 5.4N ±0.5N
ISO 389-3 2016, ANSI S3.6-2018 Headband Static Force 5.4N ±0.5N
Free Field
ISO 389-7 2005, ANSI S3.6-2018
High Frequency
ISO 389-5 2006, ANSI S3.6-2018
Effective masking
ISO 389-4 1994, ANSI S3.6-2018
Patient response switch:
Handheld push button.
Patient communication:
Talk Forward and Talk Back.
Monitor:
Output through external earphone or speaker.
Stimuli:
Pure tone, Warble tone, NB, SN, WN, TEN noise, PED noise, Wave
files.
Tone
125-20000Hz separated in two ranges 125-8000Hz and 8000-20000Hz.
Resolution 1/2-1/24 octave.
Warble tone
1-10 Hz sine +/- 5% modulation
Wave file
44100Hz sampling, 16 bits, 2 channels
Masking
Automatic selection of narrow band noise (or white noise) for tone
presentation and speech noise for speech presentation.
Narrow band noise:
IEC 60645-1:2017, ANSI S3.6-2018 , 5/12 Octave filter with the same
center frequency resolution as pure Tone.
White noise:
80-20000Hz measured with constant bandwidth
Speech noise.
IEC 60645-1:2017, ANSI S3.6-2018. 125-6300Hz falling 12dB/octave
above 1KHz +/-5dB
Presentation
Manual or Reverse. Single or multiple pulses. pulse time adjustable from
200mS-5000mS in 50mS steps. Simultaneous or alternating.
Intensity
Check the accompanying Appendix for maximum output levels
Steps
Available Intensity Steps is 1, 2 or 5dB
Accuracy
Sound pressure levels: ± 3 dB.
Vibration force levels: ± 4 dB.
Extended range
function
If not activated, the Air Conduction output will be limited to 20 dB below
maximum output.
Frequency
Range: 125Hz to 8kHz (Optional High Frequency: 8 kHz to 20 kHz)
Accuracy: Better than ± 1 %
Distortion (THD)
Sound pressure levels: below 2.5 %
Vibration force levels: below 5.5 %.