Safety; Indication Of Use; Contraindications - Nuvo INVU Quick User Manual

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Safety

2.1

Indication Of Use

INVU by Nuvo™ is a maternal-fetal monitor that non-invasively measures
and displays fetal heart rate (FHR) and maternal heart rate (MHR).
The INVU Sensor Band™ acquires and displays the FHR and MHR
tracings from abdominal surface electrodes that pick up the fetal heart
biopotential and maternal heart biopotential signals, and from surface
acoustic sensors that pick up the fetal PCG (fPCG; phonocardiogram) and
the maternal PCG (mPCG; phonocardiogram) signals.
INVU by Nuvo™ is indicated for use by pregnant women who need
documentation of fetal heart rate activity, and who are in their 32nd
week of gestation (or later), with a singleton pregnancy. INVU by Nuvo™ is
intended to be used for a maximum of five minutes.
The INVU by Nuvo™ maternal-fetal monitor is intended for use in the
antepartum period by healthcare professionals in health care facilities
and by the patient in the patient's home, on the order of a physician.
The INVU by Nuvo™ is not intended for use in critical care situations or in
laboring patients or those patients hospitalized for or suspected to have
preterm labor.
INVU by Nuvo™ is not intended to be used for antepartum monitoring
(e.g., non-stress testing).
2.2

Contraindications

INVU by Nuvo™ should not be used by pregnant women who meet one
(or more) of the criteria below :
• Multiple gestation pregnancy (more than one fetus).
• BMI ≥45 or ≤15 prior to pregnancy.
Fetal anomaly.
•
• Uncontrolled hypertension.
Medical skin condition (for example, Edema, Erythema or any open
•
wound, irritation and/or any skin infection).
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