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10/29/20 1:52:12 PM – IFU
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Contraindications:
The device is not intended for use on patients who have implanted defibrillator or
pacemaker.
The device is not intended as a stand-alone diagnostic monitor, but the data can
be used to diagnose health status.
Warnings:
Depending on wireless connectivity, a temporary interruption of data
transmission is possible, which may impact continuous or real-time monitoring.
Data will be stored on sensor device or gateway for transfer once connectivity is
reestablished.
The nature of hydro-gel silicone or hydrocolloid adhesives may cause adverse
skin reactions. Healthcare providers should advise patients to seek medical
attention if either of the following occurs:
•
Allergic reaction that persisting beyond 24 Hours
Relative contraindications:
•
Histories of skin allergic reactions irritations should be considered before placing
the patch on a patient.
•
Do not place device on broken skin.
•
This device is not intended to replace appropriate medical supervision and safe
practices.
•
Clinical validation has not been performed on patients who are pregnant or
breastfeeding.
Warnings:
•
This device is not intended to replace appropriate medical supervision and safe
practices.
•
Do not use this device during an MRI scan or in a location where it will be
exposed to strong electromagnetic forces.
