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5 General Technical Specifications
Standards:
Meets or exceeds EN 60645-1 type 4 and ANSI S3.6
Safety Standard: EN 60601-1, Class II, type B.
EMC: EN 60601-1-2
Calibration:
PTB/DTU report 2009 (DD45)
ISO 389-1 1998, ANSI S3.6-2010 (TDH39)
ISO 389-2 1994, ANSI S3.6-2010 (E.A.R Tone 3A/5A)
ISO 389-2 (EAR-Tone 3A and 5A)
PTB Report 1.61-64/04 (HDA280).
PTB Report 1.61-4039503/09 (DD65)
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. TÜV Product Service, Identification No. 0123, has approved the
quality system.
Frequencies and Intensities:
Freq. Hz.
Inputs: Tone
Warble Tone ±5%, 5Hz (true sine wave frequency modulation).
Outputs: Left and Right.
Tone Presentation:
Manual or Reverse (chosen in Setup Menu).
Multiple pulses 250 or 500msec (chosen in Setup Menu.).
Talk Forward:
Auto Threshold:
Store Function:
D-0127810-A – 2020/05
AS608 - Instructions for Use - US
AC, dB HL
125
70
250
90
500
100
750
100
1000
100
1500
100
2000
100
3000
100
4000
100
6000
100
8000
90
Built in talk forward microphone. 0-110dB SPL. Continuously adjustable on
operation panel.
Patient controlled Hughson Westlake procedure according to ISO 8253-1.
Soft key (F-key) store button and internal memory for AC L/R. Stored
Measurements can be viewed on the build in display or transferred to the PC
using the Diagnostic Suite Audiogram software module.
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