Technical Specifications Of The Ac440 Software - Interacoustics Affinity Compact Instructions For Use Manual

3.2.4 Technical specifications of the AC440 Software

Medical CE-mark:
Audiometer standards:
Transducers & calibration:
Air Conduction
DD45
TDH39
DD65 v2
HDA300
DD450
E.A.R Tone 5A
IP30
Bone Conduction
B71
B81
Free Field
High Frequency
Effective masking
Patient response switch:
Patient communication:
Monitor:
Stimuli:
Tone
Warble tone
Wave file
Masking
Narrow band noise:
White noise:
Speech noise.
Presentation
Intensity
Steps
Accuracy
Extended range
function
Frequency
Distortion (THD)
D-0123672-H – 2022/05
Affinity Compact - Instructions for Use - US
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 – identif ication no. 0123.
Tone: IEC60645-1 2017/ANSI S3.6 2018 Type 1 EHF
Speech: IEC60645-1 2017/ANSI S3.6 2018 Type A or A-E
Calibration inf ormation and instructions are in the Service manual.
Check the accompanying Appendix f or RETSPL levels f or transducers
ISO 389-1 2017, ANSI S3.6 2018
ISO 389-1 2017, ANSI S3.6 2018
PTB 1.61-4091606/18, AAU 2018
PTB report 1.61.4066893/13
ISO 389-8 2004, ANSI S3.6 2018
ISO 389-2 1998, ANSI S3.6 2018
ISO 389-2 1998, ANSI S3.6 2018
Placement: Mastoid
ISO 389-3 2016, ANSI S3.6 2018
ISO 389-3 2016, ANSI S3.6 2018
ISO 389-7 2005, ANSI S3.6 2018
ISO 389-5 2006, ANSI S3.6 2018
ISO 389-4 1994, ANSI S3.6 2018
Handheld push button.
Talk Forward and Talk Back.
Output through external earphone or speaker.
Pure tone, Warble tone, NB, SN, WN, TEN noise, PED noise, Wave
f iles.
125-20000Hz separated in two ranges 125-8000Hz and 8000-20000Hz.
Resolution 1/2-1/24 octave.
1-10 Hz sine +/- 5% modulation
44100Hz sampling, 16 bits, 2 channels
Automatic selection of narrow band noise (or white noise) f or tone
presentation and speech noise f or speech presentation.
IEC 60645-1 2017, ANSI S3.6 2018, 5/12 Octave f ilter with the same
center f requency resolution as pure Tone.
80-20000Hz measured with constant bandwidth
IEC 60645-1 2017, ANSI S3.6 2018. 125-6300Hz f alling 12dB/octave
above 1KHz +/-5dB
Manual or Reverse. Single or multiple pulses. pulse time adjustable f rom
200mS-5000mS in 50mS steps. Simultaneous or alternating.
Check the accompanying Appendix f or maximum output levels
Available Intensity Steps is 1, 2 or 5dB
Sound pressure levels: ± 3 dB.
Vibration f orce levels: ± 4 dB.
If not activated, the Air Conduction output will be limited to 20 dB below
maximum output.
Range: 125Hz to 8kHz (Optional High Frequency: 8 kHz to 20 kHz)
Accuracy: Better than ± 1 %
Sound pressure levels: below 2.5 %
Vibration f orce levels: below 5.5 %.
Headband Static Force 4.5N ±0.5N
Headband Static Force 4.5N ±0.5N
Headband Static Force 11.5N±0.5N
Headband Static Force 8,8N ±0.5N
Headband Static Force 10N ±0.5N
Headband Static Force 5.4N ±0.5N
Headband Static Force 5.4N ±0.5N
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