Nuvo INVU Instruction manual

Quick User Guide

2

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The disclosure, duplication, distribution or editing of this document or
utilization and editing of the content herein are not permitted unless
expressly authorized in writing by Nuvo Group. All intellectual property
rights including those created by patent grant or registration of a utility
model or a design, are expressly reserved.
The following are trademarks or registered trademarks of Nuvo® Group
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
Nuvo GIVE LIFE A BETTER BEGINNING logo. All other company or product
names are the trademarks or registered trademarks of their respective
holders.
Nuvo reserves the right to change or improve its products and
accompanying technical literature without specic notice.
All subject information and images used in this document are
ctitious. The information and images do not relate to any persons
either living or deceased.
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

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2 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 BandTM acquires the fetal heart electrocardiogram
and maternal heart electrocardiogram signals from abdominal
surface electrodes and the fetal 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 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
• Pregnant women with known heart issues such as arrhythmia, etc.
• Known allergy to the INVU Sensor Band™ materials as listed in
section 3.2.2 page 20.
• 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.
• INVU by Nuvo™ is not to be used in laboring patients or those
patients hospitalized for or suspected to have preterm labor.
Using the INVU by Nuvo™ for unintended purposes or with incompatible
equipment may result in incorrect results and clinical misinterpretations.
2.4 Adverse Events
There are no known adverse events related to the use of INVU by Nuvo™;
however, there are possible adverse events related to monitoring systems
that involve sensor application on the skin. These include the following:
• Edema

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• Erythema
• Irritation
• Sensitization
2.5 General Warnings and Cautions
WARNINGS:
• NEVER wear the INVU Sensor Band™ while it is being charged!
• NEVER try to replace the rechargeable battery!
• If the INVU Sensor Band™ package, INVU Sensor Band™, or any of its
accessories are damaged or are not intact — do not use the device
and contact Nuvo Group customer support.
• INVU Sensor Band™ contains no user-serviceable components. Do
not try to repair this product or any of its parts. Contact Nuvo Group
customer support.
• Keep the INVU Sensor Band™ away from the reach of children. Do not
leave the device unattended, or at the sole presence of kids or pets
that might unintentionally harm the device.
• Maintain proper storage and usage of the INVU Sensor Band™, and
always keep it dry. Avoid exposing the device to direct sunlight,
liquids, dirt or any other environmental hazard that might damage its
performance.
• INVU Sensor Band™ is a stand-alone device. It does not require
another adjacent or stacked device for normal operation.
• The use of this equipment adjacent to or stacked with other
equipment should be avoided, as it might result in improper operation.
If such use is necessary, this equipment and the other equipment
should be observed to verify that they are operating normally.
• INVU Sensor Band™ power cable must be positioned and/or
restrained to avoid user suffocation of strangulations.
• Do not use the INVU Sensor Band™ if you experienced any contact
related injuries (e.g., skin irritation) as a result of previous use.

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• Portable RF communications equipment (including peripherals
such as antenna cables and external antennas) should be used no
closer than 30 cm (12 inches) to any part of the INVU Sensor Band™.
Otherwise, degradation of the performance of the INVU Sensor Band™
could result. The safety and effectiveness of intrapartum use of the
INVU has not been established.
•
CAUTIONS:
• Do not use the INVU Sensor Band™ after its expiration date.
NOTE
INVU by Nuvo™ will not function if the battery is depleted.
If the INVU Sensor Band™ battery does not charge, contact
Nuvo Group customer support.
2.6 INVU by Nuvo™ Usage Restrictions
INVU Sensor Band™ must be removed prior to:
• Magnetic Resonance Imaging (MRI) scans
• Computer Tomography (CT) scans
• Direct x-rays
• Defibrillator use
• ECG and EMG connection
• Any other potential exposure to a strong electromagnetic field.
2.7 Regulatory Classification
The INVU by Nuvo™ system, including the INVU™ App, is classified as
Class II (US).
2.8 Complying with Standards
The INVU Sensor Band™ was approved as per IEC 60601-1-2:2014, which
contains tests of immunity to proximity RF fields of different RF wireless
communication equipment. The test was implemented in accordance
with clause 8.1 which defined the maximum power of the wireless

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equipment and its minimum distance to the INVU Sensor Band™ at which
the INVU Sensor Band™ functionality stays steady. Thus, Portable RF
communications equipment (including peripherals such as antenna
cables and external antennas) should be used no closer than 30 cm (12
inches) to any part of the INVU Sensor Band™. Otherwise, degradation
of the performance of the INVU Sensor Band™ could result. For EMC and
wireless information, it is recommended to refer to the INVU user manual.
Note: Disposal of this device should be performed in
accordance with local regulations and WEEE (Waste of Electrical
and Electronic Equipment). Alternatively, the user can send
the device for disposal back to the manufacturer or its local
distributor.
2.9 Privacy and Security
INVU™ App was designed with the utmost care for patient privacy.
The application was designed and found to comply with the Health
Insurance Portability and Accountability Act (HIPAA), the organization
that establishes national standards for electronic health care
transactions. Applicable standards for INVU by Nuvo™: HIPAA (45 CFR
Parts 160 & 164).

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3 Know Your INVU Sensor Band™
This section describes the INVU sensor band™ and its accessories.
3.1 INVU Sensor Band™ Package Contents
The following items are included in the INVU sensor band™ packaging:
Figure 3-1. INVU Sensor Band™ package contents
Item Description
Carrying case
INVU Sensor Band™
Medical grade power supply and charging cable
ECG gel (Spectra 360®) (x2)
Cleaning Isopropyl Alcohol Spray (Safetec)
User manual/quick guide
Detachable (bio-potential) sensors (×10)
If you have any questions regarding the contents of the package, or any
of the components is damaged, or missing, please contact Nuvo Group
customer support immediately at [email protected] or at:
1-800-554-9041 (USA only).
Do not attempt to repair the system by yourself.
3.2 INVU Sensor Band™ Components
The INVU Sensor Band™ includes the following main parts:
• Band fabric, with integrated sensors. The fabric is made of Polyamide
and Elastane coated with Thermoplastic Polyurethane (TPU).
• Detachable (bio-potential) sensors.
• Acoustic sensors.
• Two back straps and four frontal adjustment straps.

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• Controller – An electronic module that controls the band. It includes
the On/Off Power button, a rechargeable battery, data storage, and a
Bluetooth communication module.
NOTE
The bio potential sensors arrive in the package detached from
the band. Before your monitoring session 8 of the detachable
(bio-potential) sensors should be attached.
The following pictures depict the INVU Sensor Band™ and its main components.
Figure 3-2. INVU Sensor Band™ interior view (the side facing abdomen skin)
Item Description
Rear closing strap with a buckle
Detachable (bio-potential) sensors (×8)
Acoustic sensors (×4)
Textile band
Rear closing strap with a buckle
WARNING
Do not use any other detachable sensors other than the
ones supplied in the INVU Sensor Band™ package
Figure 3-3. INVU Sensor Band™ exterior view (the outer side)

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Item Description
Rear closing strap
Controller with On/O power button
Lower frontal adjustment straps (×2)
Textile band (upper strip) with logo
Textile band (lower strip)
Upper frontal adjustment straps (×2)
Plastic with the band QR-code
Rear closing strap
3.2.1 Controller
The Controller includes the On/Off power button, LED indicators, and a
rechargeable battery.
The On/Off power-button is located in the center of the controller case.
• INVU Sensor Band™ is powered ON by a short press on the power
button.
• INVU Sensor Band™ is powered OFF by a long press (longer than two
seconds) on the power button.
WARNING
Do not press the power button for more than 6 seconds as
it could switch to a non-operational mode, which will not
allow working with the INVU Sensor Band™.
Functional indicator
(for the On/O
button)
Charging port
(Charging indicator)
Figure 3-4. Controller LEDs location

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The Controller has two LED indicators:
• Functional LED indicator: a 3-color LED, integrated into the On/Off
power button, that is visible from the top and side of the controller.
• Battery charging LED indicator: a 2-color LED, adjacent to the
charging port.
When power is OFF, the LED indicators are turned off. When charging,
the LED indicator near the power socket lights in orange and turns green
when the battery is fully charged.
Indicator
Location
LED
Color
LED
Behavior
State/Functionality
Input power
connector
(battery
status)
Orange Steady Power OFF – Battery
charging
Green Steady Power OFF – Battery is fully
charged
When power is ON, the Controller LED color and state indicate the status
of the device (see Figure 3-4 above).
Indicator
Location
LED
Color
LED
Behavior State/Functionality
On/O
power
button
(status LED)
Green
Steady Standby, Ready to use
Blinking Power up
Blue
Steady Bluetooth connected
Blinking In monitoring session
Red
Steady Malfunction
Blinking Low battery (less than 20%)
Green
Blue
Blinking Firmware over the air upgrade
NOTE
Make sure that one of the indicator lights is lit at all times
during a monitoring session.

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The battery is integrated into the INVU Sensor Band™ Controller and is
charged by the medical-grade power supply through the USB type C
connector. The medical-grade power supply is supplied as part of the
INVU Sensor Band™ package.
• Charging time (from an empty battery to a fully charged battery) is
around two hours.
• Under typical conditions, a fully charged battery will provide ~4.5
hours of continuous monitoring.
NOTE
The INVU Sensor Band™ battery is pre-charged before
shipping. However, it is recommended recharging it before
rst use to a fully charged battery.
3.2.2 Materials
• Fabric of the band- (80% Polyamide and 20% Elastane and TPU
[Polyester-based Thermoplastic Polyurethane]).
• Components of the bio potential sensors- Polycarbonate (PC), TPE -
TM4ADT, Silver Chloride (AgCl), Stainless steel (SS).
• Components of the acoustic sensors- Polyamide, Elastomer, Silver,
Polyurethane, and Aluminum.
• Plastic components: PC Makrolon 2485, TPE - TM4ADT.
• The full materials used in the manufacturing of the INVU Sensor
Band™ are:
• Brass, PC Makrolon 2485, Nylon / Spandex,PA ( FPCBA ),
Monomer Cyanoacrylate, PTEE ( White ), PTEE + polyester, PU,
Al6061, PC / Lexan 8040, Stainless Steel, Synthetic Rubber,
Polyester, 80% Polyamide / 20 % elastane, PU, Thermoplastic
Polyurethane Ester Grade, TPU composite lm, Nylon / AgCl, TPE
- TM4ADT, PVC (wire).