Interacoustics Affinity2.0 User Manual

D-0004578-R – 2022/05 Page 32
Affinity2.0/Equinox2.0 - Instructions for Use - US
3.2.4 Technical specifications of the AC440 software
Medical CE-mark:
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.
Audiometer standards:
Tone: IEC60645-1 2017/ANSI S3.6 2018 Typ e 1 EHF
Speech: IEC60645-1 2017 /ANSI S3.6 2018 Type A or A-E
Transducers &
calibration:
Calibration information and instructions are 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
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
HDA300
ISO 389-8 2006, ANSI S3.6-2010 Headband Static Force 8,8N ±0.5N
DD450
ANSI S3.6-2018 Headband Static Force 10N ±0.5N
HDA280
PTB report 2004 Headband Static Force 5N ±0.5N
E.A.R Tone
3A/5A
ISO 389-2 1998, ANSI S3.6-2010
IP30
ISO 389-2 1998, ANSI S3.6-2018
Bone
conduction
Placemenet: 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 S3.6-2010
High
frequency
ISO 389-5 2004, ANSI S3.6-2010
Effective
masking
ISO 389-4 1994, ANSI S3.6-2010
Patient response switch:
Handheld push button.
Patient communication:
Talk Forward and Talk Back.
Monitor:
Output through external earphone or speaker.
Stimuli:
Pure tone, Wable tone,NB, SN, WN, TEN noise
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 60645-1:2001, 5/12 Octave filter with the same centre frequency resolution as
pure Tone.
White noise:
80-20000Hz measured with constant bandwidth
Speech Noise.
IEC 60645-1 2017 125-6000Hz f alling 12dB/octave above 1KHz +/-5dB
Presentation
Manual or Reverse. Single or multiple pulses. pulse time adjustable f rom 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: ± 2 dB.
Vibration f orce levels: ± 5 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)

Interacoustics Affinity2.0 Specifications

General

Brand	Interacoustics
Model	Affinity2.0
Category	Hearing Aid
Language	English