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)
Operating Systems
Compatible software
Input specifications
D-0123672-H – 2022/05
Affinity Compact - Instructions for Use - US
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 – identif ication 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 inf ormation is in the specif ications f or the sof tware modules.
Calibration inf ormation 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 ® 8 (64 bit)
Windows 10 (64 bit)
®
Windows®11 (64 bit)
Noah 4, OtoAccess® and XML compatible.
Talk back
Mic. – Talk forward
Patient respond
AUX
Insitu headset ref.
Insitu headset tube.
Ambient- calibrated
mic.
Test box reference
Test box coupler
Wave files
240µVrms at max. input gain f or 0dB VU-reading
Input impedance: 47.5KΩ
240µVrms at max. input gain f or 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 f or 0dB VU-reading
Input impedance: 68KΩ
Max input level bef ore clipping 220mVrms.
calibration by 94 dB SPL 250Hz or 1kHz.
Input impedance: 68KΩ
Max input level bef ore clipping 3800mVrms.
calibration relative to ref erence microphone.
Input impedance: 33KΩ
Max input level bef ore clipping 220mVrms.
calibration by 94 dB SPL 250Hz or 1kHz.
Input impedance: 68KΩ
Required that an Interacoustics microphone is used,
to work
Max input level bef ore clipping 220mVrms.
calibration by 94 dB SPL 250Hz or 1kHz.
Input impedance: 68KΩ
Max input level bef ore clipping 3800mVrms.
calibration relative to ref erence microphone.
Input impedance: 33KΩ
Plays wave f ile f rom hard disk drive
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