Technical Specifications - Interacoustics AD528 Instructions For Use Manual

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Technical specifications

General
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 no0123
Standards: Safety:
EMC:
Audiometer:
Operation Temperature:
environment:
Relative humidity:
Ambient pressure:
Warm-up time:
Transport & Storage temperature:
storage: Transport temperature:
Rel. humidity:
Internal battery
PC control: USB:
Printer Thermal
(optional): Direct print
UES24LCP-
Power supply
120200SPA
Dimensions H x W x L
AD528 weight
Display
D-0121151-B – 2018/11
AD528 - Instructions for Use - EN
IEC 60601-1 2005/EN 60601-1 2006 and A1 2012
ANSI/AAMI ES60601-1:2005/(R)2012
CAN/CSA-C22.2 No. 60601-1:14
Class II, Type B applied parts
IEC 60601-1-2 (2014)
Tone Audiometer: IEC 60645 -1 (2017), ANSI S3.6 (2010),
Type 2
Speech Audiometer: IEC 60645-1 (2017)/ANSI S3.6 (2010)
type B or B-E.
Auto threshold tests: ISO 8253-1 (2010)
15-35 °C
30-90%
98kPa – 104kPa
1 minute
0°C-50°C
-20-50 °C
10-95%
CR2032 3V, 230mAh, Li
Input/output for computer communication.
Diagnostic Suite, OtoAccess™, NOAH, Audiometric data
interface (ADI).
HM-E300
Printer language: HP PCL 3/HP PCL3 GUI
Use only specified power supply unit type
Input: 100-240VAC 50/60 Hz, 500mA
Output: 12.0 VDC 2.0A
11 x 28 x 36 cm
4.3 x 11 x 14 inches
1.5 kg / 3.3 lb
5 inch high resolution color display 480x272
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