EarlySense InSight AME-01350-US, User Manual

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Compliance with Standards
The EarlySense InSight System was tested and found to be in compliance with the following standards:
Standard #
Medical Electrical Equipment – Part 1: General Requirements for Basic Safety
and Essential Performance
IEC 60601-
1:2005+CORR.1:2
—
6+CORR
2:2007+A1:2012
Medical electrical equipment Part 1-6
General requirements for safety - Collateral Standard: Usability
IEC 60601-1-6:2010
+ A1:2013
Medical Electrical Equipment - Part 1: General Requirements for Basic Safety
and Essential Performance; Electromagnetic Compatibility -Requirements and
Tests
IEC 60601-1-2:2014
(Fourth edition)
and 2007+I-SH
01:2010 (third
edition)
Electromagnetic compatibility
and Radio Spectrum Matters (ERM);
Electromagnetic Compatibility (EMC)
standard for radio equipment and services
EN 301 489-1
V1.9.2:11;
EN 301 489-7
V1.3.1:05;
EN 301 489-17
V2.2.1:12
This equipment complies with IEC 60601-1-2 for electromagnetic compatibility for medical electrical
equipment and/or systems, ESD Air Discharge was tested to ± 2kV, ± 4kV, ± 8kV only.
See Appendix A for Manufacturer’s declaration and tables for specific information regarding compliance
with IEC 60601-1-2.
Supplying InSight Unit
The EarlySense InSight Device is shipped in a protective package. The Device should be unpacked and
installed only by an authorized EarlySense Technician.
The EarlySense InSight Device can only be operated by connecting to a Cradle. The Cradle is suppled
separately. For further explanation refer to EarlySense Cradle User Guide.
Supplying Sensors
The EarlySense Bed Sensing Units are supplied in a separate package. Each Sensing Unit is isolated to ensure
safe transport.
The EarlySense InSight System may also be provided with optional Chair Sensing Unit/s.
The EarlySense InSight System should be unpacked and installed only by an authorized EarlySense Technician.