Nuvo INVU Instruction manual

Quick User Guide

2

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Ltd. and/or its aliates or subsidiaries (collectively, “Nuvo”) the United
States and/or in other countries: NUVO, NUVO logo, INVU BY Nuvo, INVU
BY Nuvo logo, INVU, INVU logo, GIVE LIFE A BETTER BEGINNING and
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INVU by Nuvo™ Quick User Guide, NV-UMLS-0013 Rev. 06 November 2021
INVU by Nuvo™ is a prescription-based device.
Document references:
INVU User Manual NV-UMLS-0012 Rev. 06
https://www.nuvocares.com/support
Nuvo Group Ltd.
94 Yigal Alon St.
Tel Aviv 6789155, Israel
Tel: [phone]
Email: [e-mail]
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
1.4 Labels and Symbols 8
2 Safety 11
2.1 Indication Of Use 11
2.2 Contraindications 11
2.3 Limitation of Use 12
2.4 Adverse Events 13
2.5 General Warnings and Cautions 13
2.6 INVU by Nuvo™ Usage Restrictions 14
2.7 Regulatory Classication 15
2.8 Complying with Standards 15
2.9 Privacy and Security 15
3 Know Your INVU Sensor Band 16
3.1 INVU Sensor Band™ Package Contents 16
3.2 INVU Sensor Band™ Components 17
4First Time Using INVU by Nuvo™ 21
4.1 Preparing the Band 21
4.2 Charging INVU Sensor Band™ 21
4.3 Installing the Application 22
4.4 Logging In 23
4.5 Onboarding Process 24

5Using the INVU Sensor Band™ 29
5.1 Applying the INVU Sensor Band™ 29
5.2 Initiating a Monitoring Session 30
5.3 Removing the INVU Sensor Band™ 33
6 Maintenance 34
6.1 Cleaning the INVU Sensor Band™ 34
6.2 Repackaging the INVU Sensor Band™ 35
7Troubleshooting 38
7.1 INVU Sensor Band™ Troubleshooting 38
7.2 Monitoring Session Troubleshooting 39
7.3 Service/Call Center 45

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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)
• Uterine activity (UA)
The system includes a wearable sensory band NV-BTSH-3000 (INVU
Sensor Band™) that connects wirelessly to the INVU™ App installed on
the pregnant woman’s smartphone.
The system NV-INVU-3200 includes a wearable sensory band NV-
BTSH-3000 (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, MHR and MUA 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.
1.4 Labels and Symbols
Conventions:
The following symbols have been inserted on the left-hand side of this
manual for more comprehensive user experience:
Symbol Description
NOTE
Note: Information given in a “note” symbol
provides information that is useful to know, such
as, a supplementary operating procedure, or other
information.

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Symbol Description
CAUTION
Caution: cautions are used to warn you of a
potentially hazardous situation which, if not
avoided, may result in loss of data, or may cause
minor personal injury, equipment/property
damage, or impaired image quality.
Do not proceed beyond a CAUTION message until
you fully understand and observe the indicated
conditions.
WARNING
Warning: warning messages indicate a potential
hazard or unsafe practice which, if not avoided,
could result in misdiagnosis, mistreatment,
equipment damage, death or serious injury.
Do not proceed beyond a WARNING message until
you fully understand the conditions and you have
taken the appropriate preventive action.
The following table shows a list of symbols that may appear throughout
this manual, on accompanying documents, on the packaging or the
actual system parts. An explanation is provided next to each symbol.
Symbol Description Symbol Description
Follow instructions
for use
European Authorized
Representative (when
applicable)
Manufacturer FCC ID:
S9NSPBT30DP2
Catalog number GMDN
Fetal Cardiac
Monitor- 43958 (when
applicable)
Serial number UMDNS
Monitors, Bedside,
Fetal, Antepartum-
18339
18340
(when applicable)
Lot number BT SIG Membership
Number
Lithium battery
caution
CE 2797 (when
applicable)

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Symbol Description Symbol Description
40ºC/104ºF
5ºC/ 41ºF
Operation
Temperature
Limits
Do not use a blade to
open
45ºC/113ºF
0ºC/ 32ºF
Storage
Temperature
Limits
Indicates the total
number of products in
a package
Do not throw away
in regular waste
(WEEE)
Return at end-
of-life
Electronic device of
type BF Class II, BT, UL
1642
Do not use if
the package is
damaged
Prescription-only
Keep away from
sunlight
Degree of protection
against ingress of
water provided
Keep dry Handle with care
90%
5%
Humidity limitation RoHS2
Class II WARNING
Identify how
dierent types of
packaging can be
recycled
CAUTION
Use by date Do not wring
Do not wash Single Patient –
Multiple usages
MD Medical device
MR Unsafe – keep
away from magnetic
resonance imaging
(MRI) equipment