General Technical Specifications; Affinity Compact Hardware - Technical Specifications - Interacoustics Affinity Compact Instructions For Use Manual

5 General technical specifications

5.1 Affinity Compact Hardware - Technical Specifications

Medical CE-mark:
Safety standards
EMC standard
Calibration
PC requirements:
(recommended
minimum)
Operative system:
Compatible software
Input specifications
Output specifications
D-0123234-D – 2020/05
Affinity Compact - Instructions for Use - EN
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 (Third Edition) + CORR. 1:2006 + CORR. 2:2007 +
A1:2012,
AAMI ES60601-1:2005+A2+A1
CSA-C22.2 No.60601-1:14
Class I, Applied parts type B, Continuous operation
IEC 60601-1-2:2014
IEC 60645-1:2017
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 2.0 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. – Talk Forward
Patient respond
AUX
Insitu headset ref.
Insitu headset tube.
Ambient- calibration
mic.
Test box reference
Test box coupler
Wave files
AC headsets 1
240µVrms at max. input gain for 0dB VU-reading
Input impedance : 47.5KΩ
240µVrms at max. input gain for 0dB VU-reading
Input impedance : 47.5KΩ
Switches 3.3V to the logic input.
(The switch current is 1.5mA)
10mVrms at max. input gain for 0dB VU-reading
Input impedance : 68KΩ
Max input level before clipping 220mVrms.
calibration by 94 dB SPL 250Hz or 1kHz.
Input impedance: 68KΩ
Max input level before clipping 3800mVrms.
calibration relative to reference microphone.
Input impedance: 33KΩ
Max input level before clipping 220mVrms.
calibration by 94 dB SPL 250Hz or 1kHz.
Input impedance: 68KΩ
Required that a Interacoustics microphone is used, to
work
Max input level before clipping 220mVrms.
calibration by 94 dB SPL 250Hz or 1kHz.
Input impedance: 68KΩ
Max input level before clipping 3800mVrms.
calibration relative to reference microphone.
Input impedance: 33KΩ
Plays wave file from hard disk drive
Up to 7.0 Vrms by 10 Ω load
70Hz-20kHz ±3dB
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