Operation Manual PILOT TEST
8504660
Rev.
3
34
06/11/2019
6
Technical Data
This Section offers you important information about
▪
the PILOT TEST hardware specifications
▪
connections
▪
the pin assignment
▪
audiometry calibration values
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electromagnetic compatibility (EMC)
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electrical safety, EMC and associated standards
6.1 PILOT TEST Hardware
The PILOT TEST is an active, diagnostic medical product
according to class IIa of the EU Medical Directive 93/42/EEC.
General Information About Specifications
The performance and specifications of the device can only be guaranteed if it is
subject to technical maintenance at least once per year.
MAICO Diagnostics puts diagrams and service manuals at the disposal of authorized
service companies.
STANDARDS
Medical CE-mark
Yes
Safety Standards
IEC 60601-1:2005/EN 60601-1:2006 + A1: 2012
ANSI/AAMI ES60601-1:2005/(R)2012
CAN/CSA-C22.2 NO. 60601-1:14
Class I, Type B applied parts
EMC Standards
IEC 60601-1-2:2014
Audiometer
Standards
Tone: IEC 60645-1:2017/ANSI S3.6:2010, Type 4
DEVICE SPECIFICATIONS
Mains voltage
100-240 V~ ±10 %, 50/60 Hz
Power consumption Max. 15 VA
Mode of operation
Continuous
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