Welch Allyn EarlySense System 1.0 - Equivalent to model EverOn 1.0 - User Manual - Manual (Page 18)

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Compliance with Standards
The EarlySense System was tested and found to be in compliance with the following
standards:
How the Bedside Unit is supplied
The EarlySense System is shipped in a protective package containing the following
components:
• 1 Control Unit (Bedside unit)
• 1 Sensor
The System should be unpacked and installed only by an authorized EarlySense
technician.
STANDARD #
1.
Medical electrical equipment- general requirements
for safety. Part 1: General Requirements for Safety IEC 60601-8
(2006)
2.
Medical Electrical Equipment - Part 1: General
Requirements for Safety; Electromagnetic
Compatibility -- Requirements and Tests EN/IEC 60601-1-2
(2005)