Device Class; Applied Standards - otometrics Madsen AccuScreen PRO User Manual

Otoacoustic emissions and automated abr screener
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AccuScreen PRO User Manual
Test levels (diagnostic/multilevel): l1/l2 = 55/45 dB SPL
Measurements per test:
Display:
Result display:
ABR:
Sampling rate:
Evaluation method:
Stimulus:
Click rate:
Frame length:
Amplifier gain:
Amplifier CMRR:
Input impedance:
Input bias current:
Amplifier noise:
Input bandwidth:
Notch filter:
Impedance sense current:
Impedance sense signal:
Impedance test range:
Impedance accepted for test:
Impedance control:
Display:
Electrodes:
15.5

Device class

15.6

Applied standards

GN Otometrics A/S
l1/l2 = 65/55 dB SPL
Screening: 4 frequencies
Diagnostic/multilevel: 4 frequencies x 2 levels
Phase statistics diagram, test progress, noise
PASS/REFER for all tested levels and frequencies
10.2 kHz
Binomial statistics on template-convoluted signal
35, 40 or 45 dB nHL click
Approx. 55 Hz
170 samples/17 ms
2000
> 100 dB
10
Ω || 50 pF
10
< 10 nA
10 nV/
Hz at 1 kHz
70 Hz to 4 kHz
Digital, -40 dB at 50Hz or 60 Hz (user configurable)
5µApp
1 kHz square wave
1 to 99 kΩ
< 12 kΩ
Before test, periodically during test, stimulus continues during
impedance control
Statistical graph, test progress, EEG-level, ABR detection prob-
ability
Disposable hydrogel-electrodes (FDA approved)
II a (according to Council Directive 93/42/EEC Appendix IX)
EN 60601-1 + A1 + A2
EN 60601-1-2
Technical Specifications
93

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