Safety; Indication For Use; Contraindications; Limitation Of Use - Nuvo INVU User Manual

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Safety

2.1

Indication For Use

INVU by Nuvo™ is a maternal-fetal monitor that non-invasively measures and displays fetal
heart rate (FHR), maternal heart rate (MHR) and Uterine Activity (UA).
The INVU Sensor Band™ acquires the fetal heart electrocardiogram and maternal heart
electrocardiogram
phonocardiogram and the maternal phonocardiogram signals from surface acoustic sensors.
The FHR, MHR and UA tracings are derived from these signals and presented.
INVU by Nuvo™ is indicated for use by pregnant women who are in their 32nd week of
gestation (or later), with a singleton pregnancy.
The INVU by Nuvo™ maternal-fetal monitor is intended for use 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 indicated for antepartum fetal surveillance (i.e. non-stress testing).
This system does not prevent the onset of preterm labor nor will it prevent the occurrence
of preterm birth.
2.2

Contraindications

INVU Sensor Band™ should not be used by pregnant people 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
•
Pregnant people with known heart issues such as arrhythmia, etc.
•
Known allergy to the INVU Sensor Band™ materials as listed in section 9.3.7 page 89.
•
It is advised that the user will take all precautions while experiencing any changes in the
device's performance, that are different than the performance described in this manual.
In any such event, the user must not use the device and contact Nuvo Group customer
support.
Note:
A full list of INVU Sensor Band™ material components are listed in section 9.3.7.
2.3

Limitation of Use

•
INVU By Nuvo™ is a prescription-based device.
NV-UMLS-0012
signals from abdominal
Invu by Nuvo™User Manual
surface electrodes
Safety
and the fetal
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