SAFETY WARNINGS
20 MultiConnect
®
rCell 100 MTR-LTE Hardware Guide
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).
Notice regarding Compliance with FCC, EU, and Industry Canada
Requirements for RF Exposure
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 of the FCC rules for satisfying RF exposure compliance. This device
also meets the European RF exposure requirements of EN 62311. If an alternate antenna is used, consult user
documentation for required antenna specifications.
Compliance of the device with the FCC, EU and IC rules regarding RF Exposure was established and is given with
the maximum antenna gain as specified above for a minimum distance of 20 cm between the devices radiating
structures (the antenna) and the body of users. Qualification for distances closer than 20 cm (portable operation)
would require re-certification.
Wireless devices could generate radiation. Other nearby electronic devices, like microwave ovens, may also
generate additional radiation to the user causing a higher level of RF exposure.
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