SAFETY WARNINGS
20 MultiConnect
®
rCell 100 MTR-EV3 User Guide
Interference with Pacemakers and Other Medical Devices
Potential interference
Radio frequency energy (RF) from cellular devices can interact with some electronic devices. This is
electromagnetic interference (EMI). The FDA helped develop a detailed test method to measure EMI of implanted
cardiac pacemakers and defibrillators from cellular devices. This test method is part of the Association for the
Advancement of Medical Instrumentation (AAMI) standard. This standard allows manufacturers to ensure that
cardiac pacemakers and defibrillators are safe from cellular device EMI.
The FDA continues to monitor cellular devices for interactions with other medical devices. If harmful interference
occurs, the FDA will assess the interference and work to resolve the problem.
Precautions for pacemaker wearers
If EMI occurs, it could affect a pacemaker in one of three ways:
Stop the pacemaker from delivering the stimulating pulses that regulate the heart's rhythm.
Cause the pacemaker to deliver the pulses irregularly.
Cause the pacemaker to ignore the heart's own rhythm and deliver pulses at a fixed rate.
Based on current research, cellular devices do not pose a significant health problem for most pacemaker wearers.
However, people with pacemakers may want to take simple precautions to be sure that their device doesn't cause
a problem.
Keep the device on the opposite side of the body from the pacemaker to add extra distance between the
pacemaker and the device.
Avoid placing a turned-on device next to the pacemaker (for example, don’t carry the device in a shirt or
jacket pocket directly over the pacemaker).
Antenna
The antenna intended for use with this unit meets the requirements for mobile operating configurations and for
fixed mounted operations, as defined in 2.1091 and 1.1307 of the FCC rules for satisfying RF exposure compliance.
If an alternate antenna is used, consult user documentation for required antenna specifications.
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