Interacoustics Affinity Compact - 5 General Technical Specifications; Affinity Compact Hardware - Technical Specifications

D-0123234-D – 2020/05
Affinity Compact - Instructions for Use - EN Page 58
5 General technical specifications
5.1 Affinity Compact Hardware - Technical Specifications
Medical CE-mark:
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.
Safety standards
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
EMC standard
IEC 60601-1-2:2014
IEC 60645-1:2017
Calibration
Technical information is located in the specifications for the software modules.
Calibration information and instructions are located in the Service manual.
PC requirements:
(recommended
minimum)
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.
Operative system:
Windows
®
7 (32 and 64 bit)
Windows
®
8 (64 bit)
Windows
®
10 (64 bit)
Compatible software
Noah 4, OtoAccess® and XML compatible.
Input specifications
Talk Back
240µVrms at max. input gain for 0dB VU-reading
Input impedance : 47.5KΩ
Mic. – Talk Forward
240µVrms at max. input gain for 0dB VU-reading
Input impedance : 47.5KΩ
Patient respond
Switches 3.3V to the logic input.
(The switch current is 1.5mA)
AUX
10mVrms at max. input gain for 0dB VU-reading
Input impedance : 68KΩ
Insitu headset ref.
Insitu headset tube.
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
Ambient- calibration
mic.
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
Test box reference
Max input level before clipping 220mVrms.
calibration by 94 dB SPL 250Hz or 1kHz.
Input impedance: 68KΩ
Test box coupler
Max input level before clipping 3800mVrms.
calibration relative to reference microphone.
Input impedance: 33KΩ
Wave files
Plays wave file from hard disk drive
Output specifications
AC headsets 1
Up to 7.0 Vrms by 10 Ω load
70Hz-20kHz ±3dB