Safety; Indication Of Use; Contraindications - Nuvo invu 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 Sensor Band™ 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).
•
Implanted electronic devices (pacemakers, defibrillator, etc.)
•
During labor or at the delivery room.
•
During critical care situations or in laboring patients or those patients hospitalized for
or suspected to have preterm labor.
•
During antepartum monitoring (i.e. non-stress testing).
•
Pregnant women with known heart issues such as arrhythmia, etc.
•
Known allergy to the:
▪
Fabric of the band (80% Polyamide and 20% Elastane and TPU [Polyester-based
Thermoplastic Polyurethane]).
▪
Components of the sensors (Polyamide, Elastomer, Silver, Polyurethane, and
Aluminum).
▪
Plastic components: PA220 (Nylon12).
NV-UMLS-0001
Invu by Nuvo™User Manual
Safety
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