Technical Specifications - Interacoustics ASSR Instructions For Use Manual

ASSR Instructions for Use – English
Date: 2009-09-01 Page 6/10

Technical Specifications

The technical specifications provided here cover the general aspects of the instrument, while more
specific details can be found in the Operation Manual in english.
Standards:
IEC 60601-1 (General safety) Class I, Type BF
IEC 60601-1-1 (Safety of systems) Class I, Type BF
IEC 60601-1-2 (EMC)
IEC 60601-2-26 (Electroencephalographs)
IEC 60645-1/ANSI S3.6 (Audiometers)
IEC 60645-3 (Auditory test signals)
Medical CE-mark:
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.
PC Requirements (PC not included):
Operating System: Windows XP©, Windows 98se, Windows 2000, Vista
Processor: Pentium III, 800Mhz or better
RAM: 256MB
Hard disk: 1GB
Display Resolution: 1024 x 768 or better
USB: 1.1 or higher
System:
Eclipse Black box to connect to your own PC
Safety:
Medical Safety transformer built-in
Optical isolation to PreAmplifier
Optical USB Isolation to PC (optional)
PreAmplifier:
2 channels.
Gain: 80 dB/60 dB.
Frequency Response: 0.5-5 k Hz
Noise:4nV√Hz (0.22µV RMS (0-3kHz))
CMR ratio: Minimum >118 dB. Typical 130 dB <100 Hz
Input impedance: >10MΧ
Power: From main unit
Anti Aliasing Filter:
Analogue 5kHz 24dB / octave (30kHz Sampling rate)