Use Instructions

IFU-EUA Rev. 01
Date: 01Sep2020
Page 4 of 17
• Incorrect handling, excessive force, or dropping the Cardi/o
®
Sensor may cause malfunction or
permanent damage.
• If the Cardi/o Sensor fails to operate, contact your healthcare provider immediately.
• Dispose of the Cardi/o
®
Sensor per local laws, care facility laws or hospital laws for routine/non-
hazardous electronic waste.
Additional Warnings and Precautions for Emergency Use Authorization
(EUA)
The following additional warning and precautions apply when using the Cardi/o
®
Sensor under the
Emergency Use Authorization for general remote patient monitoring:
• The Cardi/o
®
Remote patient Monitor has neither been cleared or approved for remote monitoring
and detection of vital signs such as heart rate, respiratory rate, and heart rate variability in patients
who are undergoing treatment for COVID-19 or who have pre-existing conditions (such as
hypertension or heart failure). Such remote monitoring may reduce health care personnel to
exposure to SARS-CoV-2, the virus that causes COVID-19;
• The Cardi/o
®
Remote patient Monitor has been authorized for the above emergency use by FDA
under an EUA;
• The Cardi/o
®
Remote patient Monitor has been authorized only for the duration of the declaration
that circumstances exist justifying the authorization of the emergency use of medical devices under
section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or
revoked sooner.
• WARNING: When interpreting the Cardi/o
®
heart rate, respiratory rate and heart rate variability
measurements, data recordings should be reviewed for interference artifacts. Heart rate, respiratory
rate and heart rate variability measurements with the Cardi/o
®
Sensor may be unreliable in the
presence of significant noise or artifacts. Relevant changes in these measurements should be further
investigated using a standard 3-lead or 8-lead ECG.
• WARNING: Heart rate, respiratory rate and heart rate variability measurements with the Cardi/o
®
Sensor may be unreliable in cases of significant motion. Consider taking physiological
measurements when the patient is at rest.
• The accuracy of the Cardi/o
®
Remote Patient Monitor for measuring heart rate, respiratory rate,
heart rate variability and motion has only been tested for accuracy over 30-minute intervals.
• Using the Cardi/o
®
Remote Patient Monitor to measure heart rate, respiratory rate, heart rate
variability and motion has only been tested with the recommended Sensor placements. The
accuracy of these measurement with nonstandard Sensor placement is unknown.