Classification – Welch Allyn EarlySense System 1.0 - Equivalent to model EverOn 1.0 - User Manual User Manual
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Electrical Shock
The system contains no user serviceable parts. Do not open the system covers.
The Bedside Unit is not waterproof. Keep the Bedside Unit dry to avoid electrical shock
or malfunction.
Defibrillation
The system is Defibrillation proof Type BF applied part.
Electric Magnetic Interference
This equipment complies with IEC EN 60601-1-2:2001 for electromagnetic compatibility
for medical electrical equipment and/or systems. This standard is designed to provide
reasonable protection against harmful interference in a typical medical installation.
However, because of the proliferation of radio-frequency transmitting equipment and
other sources of electrical noise in healthcare and other environments, it is possible that
high levels of such interference due to close proximity or strength of a source might
disrupt the performance of this device. Medical electrical equipment needs special
precautions regarding EMC, and all equipment must be installed by qualified service
personnel.
WiFi Communication
The system incorporates an off-the-shelf certified Wifi communication card (complies
with FCC part 15)
Electrical Fire
Avoid placing liquids or food on any part of the System. Do not allow conductive fluids
to leak into the active circuit components of the System as this may cause a short circuit,
which could result in an electrical fire. In such an event, only fire extinguishers approved
for use on electrical fires should be used. The device is not intended for use in the
presence of flammable mixtures.
Classification
Mode 1: The unit is classified as Class I