D-0121151-B – 2018/11
AD528 - Instructions for Use - EN Page 31
5 Technical specifications
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
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
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)
environment:
storage:
Transport temperature:
-20-50 °C
Input/output for computer communication.
Diagnostic Suite, OtoAccess™, NOAH, Audiometric data
HM-E300
Printer language: HP PCL 3/HP PCL3 GUI
Power supply
UES24LCP-
120200SPA
Use only specified power supply unit type
Input: 100-240VAC 50/60 Hz, 500mA
11 x 28 x 36 cm
4.3 x 11 x 14 inches
5 inch high resolution color display 480x272