Technical Specifications Of The Ac440 Software - Interacoustics Affinity2.0 Instructions For Use Manual

3.2.4

Technical Specifications of the AC440 Software

Medical CE-mark:
Audiometer Standards:
Transducers &
Calibration:
Air
Conduction
DD45
TDH39
HDA300
DD450
HDA300
DD450
HDA280
E.A.R Tone
3A/5A
IP30
Bone
Conduction
B71
B81
Free Field
High
Freqency
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
Affinity2.0/Equinox2.0 – Instrucções para a utilização - PT
A marca CE junto com o símbolo MD indicam que a Interacoustics A/S atende aos
requisitos dos Regulamentos de Dispositivos Médicos (UE) 2017/745 Anexo I
A aprovação do sistema de qualidade é efetuada pela TÜV – n.º de identificação:
0123.
Tone: IEC60645-1: 2017/ANSI S3.6: 2018 Type 1
Speech: IEC60645-1: 2017/ANSI S3.6: 2018 Type A or A-E
Calibration information and instructions are located in the Service manual.
Check the accompanying Appendix for RETSPL levels for transducers
ISO 389-1 2017, ANSI S3.6-2018 Força estática do arco de cabeça 4.5N ±0.5N
ISO 389-1 2017, ANSI S3.6-2018 Força estática do arco de cabeça 4.5N ±0.5N
Relatório PTB 1.61.4066893/13
ISO 389-8 2004, ANSI S3.6-2018 Força estática do arco de cabeça: 10 N ±0.5N
ISO 389-8 2006, ANSI S3.6-2010 Força estática do arco de cabeça 8.8N ±0.5N
ANSI S3.6-2018
PTB report 2004
ISO 389-2 1998, ANSI S3.6-2010
ISO 389-2 1998, ANSI S3.6-2018
Placemenet: Mastoid
ISO 389-3 1994, ANSI S3.6-2018
ISO 389-3 1994, ANSI S3.6-2018
ISO 389-7 2005, ANSI S3.6-2010
ISO 389-5 2004, ANSI S3.6-2010
ISO 389-4 1994, ANSI S3.6-2010
Hand held push button.
Talk Forward and Talk Back.
Output through external earphone or speaker.
Tom puro, Tom oscilante, NB, SN, WN, Ruído TEN
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) for tone presentation and
speech noise for speech presentation.
IEC 60645-1:2001, 5/12 Octave filter with the same centre frequency resolution as
pure Tone.
80-20000Hz measured with constant bandwidth
IEC 60645-2:1993 125-6000Hz falling 12dB/octave above 1KHz +/-5dB
Manual or Reverse. Single or multiple pulses. pulse time adjustable from 200mS-
5000mS in 50mS steps. Simultaneous or alternating.
Check the accompanying Appendix for maximum output levels
Available Intensity Steps is 1, 2 or 5dB
Sound pressure levels: ± 2 dB.
Vibration force levels: ± 5 dB.
Força estática do arco de cabeça: 8,8 N ±0.5N
Força estática do arco de cabeça 10N ±0.5N
Força estática do arco de cabeça 5N ±0.5N
Força estática do arco de cabeça 5.4N ±0.5N
Força estática do arco de cabeça 5.4N ±0.5N
Page 33