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Nuvo invu Quick User Manual

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Quick User Guide

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  • Page 1 Quick User Guide...
  • Page 3 The following are trademarks or registered trademarks of Nuvo® Group Ltd. and/or its affiliates 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.

  • Page 4: Table Of Contents

    Complying with Standards Privacy and Security Know Your INVU Sensor Band INVU Sensor Band™ Package Contents INVU Sensor Band™ Components First Time Using INVU by Nuvo™ Preparing the Band Charging INVU Sensor Band™ Installing the Application Logging In Onboarding Process...
  • Page 5 Using the INVU Sensor Band™ Applying the INVU Sensor Band™ Initiating a Monitoring Session Removing the INVU Sensor Band™ Maintenance Cleaning the INVU Sensor Band™ 6.2 Repackaging the INVU Sensor Band™ Troubleshooting INVU Sensor Band™ Troubleshooting 7.2 Monitoring Session Troubleshooting 7.3 Service/Call Center...

  • Page 6: Introduction

    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...
  • Page 7 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).

  • Page 8: Invu By Nuvo Technology

    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;...
  • Page 9 Symbol Description 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. CAUTION Do not proceed beyond a CAUTION message until you fully understand and observe the indicated conditions.
  • Page 10 Symbol Description Symbol Description 40ºC/104ºF Operation Do not use a blade to Temperature open Limits 5ºC/ 41ºF 45ºC/113ºF Storage Indicates the total Temperature number of products in Limits a package 0ºC/ 32ºF Do not throw away in regular waste Electronic device of (WEEE) type BF Class II, BT, UL Return at end-...

  • Page 11: Safety

    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.

  • Page 12: Limitation Of Use

    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 •...

  • Page 13: General Warnings And Cautions

    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.

  • Page 14: Invu By Nuvo™ Usage Restrictions

    • 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.

  • Page 15: Complying With Standards

    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.

  • Page 16: Know Your Invu Sensor Band

    3 Know Your INVU Sensor Band™ This section describes the INVU sensor band™ and its accessories. 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...

  • Page 17: Invu Sensor Band™ Components

    Before your monitoring session 8 of the detachable (bio-potential) sensors should be attached. NOTE 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...
  • Page 18 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.
  • Page 19 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.
  • Page 20 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.

  • Page 21: First Time Using Invu By Nuvo

    Power OFF the INVU Sensor Band™. The INVU Sensor Band™ battery can be charged ONLY if the INVU Sensor Band™ power is OFF. Attempting to charge the INVU Sensor Band™ when it is powered ON will automatically NOTE power it OFF.

  • Page 22: Installing The Application

    The band battery status (charging capacity) is displayed on the INVU™ App Home screen. When charging is complete, disconnect the USB type-C plug from the Controller. When the LED turns green, it is an indication that the INVU Sensor Band™ is fully charged. NOTE Installing the Application Download and install the INVU™...

  • Page 23: Logging In

    Activate the INVU™ App by selecting the icon on your mobile device screen. Logging In Open the application by tapping the INVU™ App icon. The LOGIN screen appears. The Email Password fields are mandatory Sign in is available if you have...

  • Page 24: Onboarding Process

    Onboarding process The onboarding process walks you through connecting your band to your INVU App account and learning how to put on and use your band with a training program. The training program is mandatory before your first clinical session- be sure to complete your training before your first monitoring session.
  • Page 25 Press Next. The Scan QR Code screen appears. 4.5.1.1 Connecting via QR Code Scan Before using the INVU Sensor Band™, the band and mobile device need to be paired. Connecting the band is performed by scanning the INVU Sensor Band™ QR code.
  • Page 26 Figure 4-6. Access phone message The INVU™ QR CODE SCAN screen appears. Back to home Band screen code Figure 4-7. Band QR code Point your mobile device camera at the QR code, located on the plastic cover of the INVU Sensor Band™ controller.
  • Page 27 The device automatically scans the QR code once your smartphone camera is positioned properly over the code. When your INVU Sensor Band™ and mobile device are connected, the following ‘We Got It’ screen appears, indicating the band and your account are connected.
  • Page 28 4.5.2 Train with Your INVU Sensor Band™ Training on how to use your INVU Sensor Band™ is part of your first use of INVU by Nuvo™. During training we will walk you through putting on and using your band for optimal monitoring. This process may take up to 15 minutes.

  • Page 29: Using The Invu Sensor Band

    Using the INVU Sensor Band™ Applying the INVU Sensor Band™ Follow INVU App instructions before your monitoring session or training. The instructions flow appears before your monitoring session begins. You can access the instructions at any time via App’s Help screen.

  • Page 30: Initiating A Monitoring Session

    Minimize your movements as much as possible during monitoring. Pay attention to INVU App sounds and notifications during the session. Avoid initiating or answering phone calls or the use of any highly consuming internet bandwidth applications of your smartphone during the session setup and the monitoring itself.
  • Page 31 Controller ON/OFF power button, located on the right side of the INVU Sensor Band™. Figure 5-3. INVU Sensor Band™ power button Once the INVU sensor band™ is powered ON, wait until a steady green light appears on the Controller (see section 3.2.1 for reference).
  • Page 32 Electrostatic Discharge (ESD) events can occur during the manipulation of the INVU Sensor Band™. During Monitoring Mode, an ESD event can cause the device to turn off, without permanent damage. The device will return to normal...

  • Page 33: Removing The Invu Sensor Band

    Open the back-buckle straps and hold each back strap in separate hands. Figure 5-5. Opening the band Remove the band from your abdomen. Properly clean the band (see section 6.1). Store the INVU Sensor Band™ in its case (see section 6.2)

  • Page 34: Maintenance

    Step RINSE DETACHABLE SENSORS Detach the detachable sensors from their connectors. Figure 6-1. Detaching the bio-potential sensors from the INVU sensor band™ Rinse the detached sensors with tap water until no residue of gel is left in the sensor’s cavity.

  • Page 35: Repackaging The Invu Sensor Band

    NOTE https://www.nuvocares.com/support. Do not immerse the INVU Sensor Band™ in any liquid. If it is accidentally immersed in liquid, do not power ON the unit. Contact Nuvo Group customer support for assistance at CAUTION support@nuvocares.com or at 1-800-554-9041 (USA only).
  • Page 36 Clean the band as described in section 6.1 above. Open the INVU Sensor Band™ carrying case zipper and spread its fabric wings. The carrying case has circular cavities below the fabric wings. These cavities are designed to accommodate the band sensors.
  • Page 37 Figure 6-4. Carrying case with all components Close the carrying case with its zipper. Store the INVU Sensor Band™ in its case in a shaded place and at room temperature. Do not expose it to sunlight or excessive heat.

  • Page 38: Troubleshooting

    This section lists issues or observations that you may encounter, the possible cause(s) and recommended actions. For more troubleshooting information regarding your INVU Sensor Band ™ or the INVU™ App please refer to the detailed INVU User Manual located on our website NOTE https://www.nuvocares.com/support.

  • Page 39: Monitoring Session Troubleshooting

    The band is storage/on support at: support@nuvocares.com damaged. or 1-800-554-9041 (USA only). arrival. If a problem persists, please contact Nuvo Group customer support at support@nuvocares.com or at 1-800-554-9041 (USA only). NOTE Monitoring Session Troubleshooting Table 7-2. Monitoring session problems System...
  • Page 40 Press CONTINUE. Sensor If this message appears after a Band™ failed monitoring attempt: Attachment Remove the INVU Sensor Band™. Problem. from your abdomen. Add gel to the detachable sensors. Scrub your full abdominal skin with water and soap and towel dry it.
  • Page 41 There was a problem Detection with the detection of Problem the maternal heart while in- rate for more than session Re-attach the INVU Sensor 1 minute during the mode Band™ to your abdomen as monitoring session. (“Detecting” instructed in section 5.1 message will...
  • Page 42 System Cause Required Action Errors The system enables trying to reconnect to the Internet for up to 5 minutes, then the session will be stopped. To troubleshoot: Turn on your WiFi or cellular connection. Consider switching Internet connection - between Wi-Fi and cellular data plan.
  • Page 43 By User. process. please contact customer support at support@nuvocares.com or at 1-800-554-9041 (USA only). Turn the INVU Sensor Band™ Off and back On. Verify the controller LED light turns steady blue or green. INVU Sensor The INVU Sensor Start the session again.
  • Page 44 System Cause Required Action Errors Turn Off the INVU Sensor Band™. Remove the INVU Sensor Band™ from your abdomen and clean it. Charge it for at least 30 minutes using the INVU Sensor Band™ original charger. The battery level is Disconnect the INVU Sensor Band™...

  • Page 45: Service/Call Center

    1-800-554-9041 (USA only). NOTE Service/Call Center For any questions or issues regarding your INVU Sensor Band™, or using the INVU™ App, please contact Nuvo Group customer support at: Email: support@nuvocares.com or at 1-800-554-9041 (USA only).
  • Page 46 NOTES:...
  • Page 48 ® NV-UMLS-0013 Rev. 06 November 2021...

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