Maico easyScreen, Operation Manual

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Operation Manual easyScreen
8508935 Rev. 4 74 04/04/2019
6 Technical Data
This section offers you important information about
▪
the easyScreen hardware specifications
▪
the pin assignment
▪
calibration values
▪
electromagnetic compatibility (EMC)
▪
electrical safety, EMC and associated Standards
▪
screening protocols available via HearSIM
™
6.1 easyScreen Hardware
The easyScreen is an active, diagnostic medical product according to the
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
subjected 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
Device Safety IEC 60601-1, Internally powered, Type B and BF applied parts
IEC 60601-2-40
Cradle Safety IEC 60601-1, Class II
EMC IEC 60601-1-2 (EMC test done with default settings)
Calibration ISO 389-2
ISO 389-6
Test Signal IEC 60645-3
OAE IEC 60645-6, Type 2
3
ABR IEC 60645-7, Type 2
3
OAE Standard is met by transferring IEC protocols from HearSIM™ to the easyScreen. For detailed
information, see section 6.7 of this manual.