CONTROLLED COPY CREATED: 3/21/2014 4:59:41 PM
6
Do not rely on the seizure notification feature for delivery of life sustaining medical treatment,
such as administration of rescue medication.
If the Hub loses power, the System may miss seizure detections.
If you experience symptoms of skin irritation or allergic reaction such as redness or swelling with
the use of the Patch, remove immediately. If symptoms do not improve or get worse after
removal of the Patch, please consult your healthcare provider.
The ProGuardian System should not be used while undergoing any diagnostic medical
procedures, such as MRI or X-Ray.
The ProGuardian System should not be used in an oxygen rich environment (e.g., oxygen tent,
hyperbaric chamber).
The ProGuardian System should not be used on an airplane.
The ProGuardian System includes radio frequency technology. For complete FCC compliance
information please see Section 15.
Do not drop the Sensor or Hub. Doing so may damage the ProGuardian System.
Only use the power cord supplied with the Hub.Failing to do so can damage the System and
present a fire hazard.
Only use ProGuardian Patches. Other types of Patches will not work with your System.
Do not expose the Patch to fire or heat sources, as it contains a battery that could explode.
Do not expose the Hub, Sensor, and Patch, to water or any other liquid. Doing so may damage
the ProGuardian System.
Dispose of the lithium coin cell battery in the Patch in accordance with local regulations.
5.
Contraindications – Use Restrictions and Limits
The ProGuardian System should not be used on anyone who is:
Under 5 yearsof age
Implanted with a cardiac management device (e.g., cardiac defibrillator, pacemaker)
6.
Before You Start Using Your ProGuardian System
Read this manual.
To use the System correctly and be most comfortable using it, you need to understand how
it works and be familiar with its screen displays and system features.
Inspect each componentof the System
.
If you see any damage to any system components or if you are missing any component, call
your Customer Care Service Center immediately.
