D-0004578-R – 2022/05 Page 53
Affinity2.0/Equinox2.0 - Instructions for Use - US
5 General technical specifications
Affinity2.0/Equinox2.0 Hardware - technical specifications
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 – identification no. 0123.
IEC 60601-1: 2005 + CORR. 1:2006 + CORR. 2:2007 + A1:2012
ANSI/AAMI ES60601-1:2005 + A2:2010 + A1:2012
CAN/CSA-C22.2 No. 6061-1:14
Class I, Applied parts type B
Tone Audiometer: IEC 60645 -1, ANSI S3.6, Type 1
Speech Audiometer: IEC 60645-1, ANSI S3.6 Type B or B-E.
Technical information is in the specif ications for the software modules.
Calibration inf ormation and instructions are in the Service manual.
4GB Ram
2.5 GB available disk space
1024x768 resolution (1280x1024 or higher recommended)
Hardware accelerated DirectX/Direct3D graphics card.
One or more USB ports, version 1.1 or higher.
system:
Windows
®
7 (32 and 64 bit)
Windows
®
8 (64 bit)
Windows
®
10 (64 bit)
Noah 4, OtoAccess® and XML compatible
330µVrms at max. input gain for 0dB VU-
reading
Switches 3.3V to the logic input.
(The switch current is 33µA)
20mVrms at max. input gain f or 0dB VU-
reading
Input impedance : 15KΩ
TB Coupler - internal TB
(Affinity2.0
Insitu L & R - Probe mic.
10mVrms at max input gain for 0dB VU-
reading
7mVrms at max. input gain for 0dB VU-
reading
Input impedance : 4,3KΩ
TB Ref – internal TB
(Affinity2.0
.0
Plays wave file from hard disk drive
FF1 / FF2
(Terminal Block)
Up to 12.6Vrms by 8 Ω load
70Hz-20kHz ±3dB
Minimum speaker impedance: 4
Ω