Operation Manual easyTone
8529689 Rev. 2
54
10/05/2022
6 Technical Data
This section offers you important information about
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the easyTone hardware specifications
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connection ans pin assignment
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calibration values and maximum levels
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electromagnetic compatibility (EMC)
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electrical safety, EMC and associated standards
6.1 easyTone Hardware and Software
The easyTone is an active, diagnostic medical product according to the
class IIa of the Medical Device Regulation (EU) 2017/745.
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 every 12 months.
MAICO Diagnostics puts diagrams and service manuals at the disposal of authorized
service companies.
STANDARDS
Safety Standards
IEC 60601-1: 2005 + Corr. 1:2006 + Corr. 2:2007 + AM1:2012/
ANSI/AAMI ES60601-1:2005 + A2:2010/
CAN/CSA-C22.2 No. 60601-1:14
Type B applied parts, USB powered
EQUIPMENT with means of connection to a SUPPLY MAINS
complied with CLASS I or CLASS II ME EQUIPMENT
requirements when so connected, and when not connected to
SUPPLY MAINS with INTERNALLY POWERED ME
EQUIPMENT requirements.
EMC Standard
IEC 60601-1-2:2014 + AMD1:2020
Audiometer
Standards
Tone: IEC 60645-1:2017/ANSI/ASA S3.6-2018, Type 4
Summary of Contents for easyTone
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