General Technical Specifications - Interacoustics Affinity 2.0 Manual De Instrucciones

5 General technical specifications

Medical CE-mark:
Safety standards
EMC standard
Audiometer standards
Calibration
PC requirements:
Operative
system:
Compatible software
Input specifications
Output specifications
Affinity2.0 – Instructions for Use - EN
Affinity2.0 Hardware - technical specifications
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.
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
IEC 60601-1-2
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 located in the specifications for the software
modules.
Calibration information and instructions are located in the Service manual.
2 GHz Intel i3 processor
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.
Windows 7 (32 and 64 bit)
®
Windows 8 (64 bit)
®
Windows 10 (64 bit)
®
Noah 4, OtoAccess® and XML compatible
Talk Back
Mic. 1/TF & Mic. 2
Pat. Resp. L & R
Inp. Aux. 1 & 2
TB Coupler
TB Coupler - internal TB
(Affinity2.0 only)
.0
Insitu L & R - Probe mic.
CD1 & CD2
TB Ref.
TB Ref – internal TB
(Affinity2.0 .0 only)
Insitu L & R - Ref. mic
Ref.Mic./Ext.
Coupler/Ext.
Wave files
FF1 / FF2
(Terminal Block)
TB Lsp.
FF1/ FF2
Sp 1, Sp 2, Sp 3, Sp 4
330µVrms at max. input gain for 0dB VU-
reading
Input impedance: 47.5KΩ
Switches 3.3V to the logic input.
(The switch current is 33µA)
20mVrms at max. input gain for 0dB VU-
reading
Input impedance : 15KΩ
10mVrms at max input gain for 0dB VU-
reading
Input impedance: 10kΩ
7mVrms at max. input gain for 0dB VU-
reading
Input impedance : 4,3KΩ
Not in use
Plays wave file from hard disk drive
Up to 12.6Vrms by 8 Ω load
70Hz-20kHz ±3dB
Up to 7Vrms by 600Ω load
70Hz-20kHz ±3dB
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