Nuvo INVU Manuale di istruzioni
Quick User Guide
2
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NUVO, NUVO and logo, INVU by Nuvo, INVU by Nuvo and logo, INVU, INVU
Sensor band, INVU Pro are Trademarks and/or Registered Trademarks of
Nuvo Group Ltd. its subsidiaries or aliates in the United States and/or
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expressly granted are reserved.
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ctitious. The information and images do not relate to any persons
either living or deceased.
INVU by Nuvo™ Quick User Guide, NV-UMLS-0002 Rev. 01 July 2020
INVU by Nuvo™ is a prescription-based device.
Document references:
INVU User Manual NV-UMLS-0001 Rev. 01
https://www.nuvocares.com/support
Nuvo Group Ltd.
94 Yigal Alon St.
Tel Aviv 6789155, Israel
Tel: +972-36242266
Email: support@nuvocares.com
Website: http://www.nuvocares.com
Table of Contents
1Introduction 6
1.1 Preface 6
1.2 INVU by Nuvo™ Overview 6
1.3 INVU by Nuvo™ Technology 8
2 Safety 9
2.1 Indication Of Use 9
2.2 Contraindications 9
2.3 Limitation of Use 10
2.4 Adverse Events 11
2.5 General Warnings and Cautions 11
2.6 INVU by Nuvo™ Usage Restrictions 12
2.7 Regulatory Classication 13
2.8 Complying with Standards 13
2.9 Privacy and Security 13
3 Know Your INVU Sensor Band 14
3.1 INVU sensor band™ Package Contents 14
3.2 INVU sensor band™ Components 15
4First Time Using INVU by Nuvo™ 19
4.1 Charging INVU Sensor Band™ 19
4.2 Installing the Application 20
4.3 Logging In 20
4.4 Connecting Your Device 21
4.5 Connecting via QR Code Scan 22
5Using the INVU Sensor Band™ 26
5.1 Applying the INVU sensor band™ 26
5.2 Initiating a Monitoring Session 31
5.3 Removing the INVU Sensor Band™ 34
6 Maintenance 35
6.1 Cleaning the INVU Sensor Band™ 35
6.2 Repackaging the INVU Sensor Band™ 36
7Troubleshooting 39
7.1 INVU Sensor band™ Troubleshooting 39
7.2 Monitoring Session Troubleshooting 40
7.3 Service/Call Center 46
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1 Introduction
1.1 Preface
This Quick User Guide describes the INVU by Nuvo™ system and provides
instructions on how to use the INVU Sensor Band™ and INVU™ App for
performing monitoring sessions of the fetus and the pregnant woman.
For a detailed user manual, kindly refer to:
https://www.nuvocares.com/support and download the complete user
manual.
1.2 INVU by NuvoTM Overview
The INVU by Nuvo™ System is a safe, non-invasive wearable monitoring
system, that provides continuous passive monitoring of vital pregnancy
data of the pregnant woman and her fetus, through the INVU™ App. The
information it provides is:
• Fetal heart rate (FHR)
• Maternal heart rate (MHR)
The system includes a wearable sensory band (INVU Sensor Band™) that
connects wirelessly to the INVU™ App installed on the pregnant woman’s
smartphone.
The system may include additional peripheral devices, such as a blood
pressure measuring device, depending on the care plan prescribed by
the pregnant woman’s medical supervisor. The INVU™ App installed
on the pregnant woman’s smartphone can log the measured blood
pressure.
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The monitored pregnancy data is displayed on the mobile device by the
INVU™ App. The recorded monitored pregnancy data can also be viewed
by an assigned medical supervisor. (or by a remote monitoring medical
service), using the INVU Pro™ web application (not described in this
manual).
Figure 1-1. INVU by Nuvo™ system and applications
Item Description
INVU Sensor Band™
Smartphone with INVU™ App for the pregnant woman and with
INVU Pro™ web application for the clinician
Cloud storage and signal processing
INVU™ end-user (pregnant woman)
INVU Pro™ end-user – Clinician
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1.3 INVU by NuvoTM Technology
The INVU by Nuvo™ Technology includes the processing of signals that
are measured by passive, non-invasive, acoustic and bio-potential
surface sensors which are placed on the intact skin of the maternal
abdomen. The sensors are attached to the pregnant woman’s abdomen
by a uniquely designed band (INVU Sensor Band™), which transmits the
measured data via cloud-based algorithms to a server that processes the
measured data for near real-time pregnancy status monitoring.
INVU by Nuvo™ acquires and displays the FHR and MHR tracing from
bio-potential sensors that pick up the Fetal ECG (fECG) and the maternal
ECG (mECG) signals, and from the acoustic sensors that pick up the
fetal PCG (fPCG; phonocardiogram) and the maternal PCG (mPCG;
phonocardiogram) signals.
1.3.1 Data presented to the pregnant woman
• Average FHR of the entire session.
• Average MHR of the entire session.
• Kicks added by the pregnant woman during the monitoring session.
The pregnant woman monitored data will be shared with her assigned
doctor/medical supervisor.
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2 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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• 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).
• 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.
2.3 Limitation of Use
• INVU Sensor Band™ is a prescription-based device.
• This monitoring system does not prevent the onset of pre-term
labor, nor will it prevent the occurrence of pre-term contractions.
• INVU by Nuvo™ is not intended for use in the delivery room during
laboring.
• Using the INVU by Nuvo™ for unintended purposes or with
incompatible equipment may result in incorrect results and clinical
misinterpretations.
• INVU by Nuvo™ is not to be used during an external defibrillation
process. The device must be removed before defibrillation initiation.
Altri manuali per INVU
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Indice
