Technical Data; Easyscreen Hardware - Maico easyScreen Operation Manual

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
Device Safety
Cradle Safety
EMC
Calibration
Test Signal
OAE
ABR
OAE Standard is met by transferring IEC protocols from HearSIM™ to the easyScreen. For detailed
3
information, see section 6.7 of this manual.
8508935 Rev. 4
Operation Manual easyScreen
Yes
IEC 60601-1, Internally powered, Type B and BF applied parts
IEC 60601-2-40
IEC 60601-1, Class II
IEC 60601-1-2 (EMC test done with default settings)
ISO 389-2
ISO 389-6
IEC 60645-3
IEC 60645-6, Type 2
IEC 60645-7, Type 2
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74 04/04/2019