beautypg.com

Classification – Welch Allyn EarlySense System 1.0 - Equivalent to model EverOn 1.0 - User Manual User Manual

Page 11

background image

5

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