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Nuvo INVU Instructions For Use Manual

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INVU by Nuvo™Instruction For Use
Table of Contents
Instruction For Use
NV-UMLS-0019
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  • Page 1 INVU by Nuvo™Instruction For Use Table of Contents Instruction For Use NV-UMLS-0019...
  • Page 2 (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.

  • Page 3: Table Of Contents

    2.10 Complying with Standards ..................10 2.11 Privacy and Security ....................10 Know Your INVU Sensor Band ™ ............12 INVU Sensor Band™ Package Contents..............12 INVU Sensor Band™ Components ................. 13 Charging the INVU Sensor Band™ Battery ............17 Standard Operation Duration ................
  • Page 4 Introduction Preface Supported Mobile Devices ..................34 INVU Pro compatibility ..................34 Communication Requirements ................34 Troubleshooting ..................36 INVU Sensor Band™ Troubleshooting ..............36 Service/Call center ....................37...

  • Page 5: Introduction

    Instruction For Use. • Do not use INVU by Nuvo™ for any purpose other than those for which it is intended. The operation of INVU Sensor Band™ for unintended purposes or with incompatible equipment could lead to incorrect results and clinical misinterpretation.
  • Page 6 Introduction INVU by Nuvo™ Overview The monitored pregnancy data is displayed on the mobile device by the INVU™ App accessory. 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 accessory(not described in this manual).

  • Page 7: Invu By Nuvo™ Technology

    Figure 1-1. INVU by Nuvo™ system and applications INVU by Nuvo™ 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 pregnant person’s abdomen. The sensors are attached to the pregnant person’s abdomen by a uniquely designed band (INVU Sensor Band™...

  • Page 8: Labels And Symbols

    An explanation is provided next to each symbol. Symbol Description Symbol Description Follow European Authorized instructions for Representative Manufacturer FCC ID: S9NSPBT30DP2 Fetal Cardiac Monitor - Catalog number GMDN 43958 Serial number UMDNS Fetal monitors- 12610 BT SIG Membership Lot number Number Nuvo Group Ltd.
  • Page 9 Symbol Description Symbol Description lithium battery CE 2797 caution 40°C/104°F Operation Temperature Do not use a blade to open Limits 5°C/41°F 45°C/113°F Storage Indicates the total number Temperature of products in a package Limits 0°C/32°F Do not throw away in regular Electronic device of type BF waste (WEEE) Class II, BT, UL 1642...
  • Page 10 Introduction Labels and Symbols Symbol Description Symbol Description Single Patient – Multiple Do not wash usages MR Unsafe – keep away Medical device from magnetic resonance imaging (MRI) equipment Distributer Manufacturing date Nuvo Group Ltd.

  • Page 11: Safety

    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). 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

    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. Adverse Events There are no known adverse events related to the use of INVU by Nuvo™;...

  • Page 13: General Warnings And Cautions

    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.

  • Page 14: Invu By Nuvo™ Usage Restrictions

    (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 •...
  • Page 15 2. Logout: The INVU app and INVU Pro will automatically log out after 30 minutes of inactivity. Ensure that your application is not left exposed to other users while you are still logged in. 3. Automatic Updates: Our device supports automatic updates to keep your firmware and software secure.

  • Page 16: Know Your Invu Sensor Band

    For protection during shipment and while not in use, INVU Sensor Band™ should be stored in the provided carrying case. Note: Do not use an expired item. Always look for the expiration date on the INVU Kit Packaging Label. INVU Sensor Band™ Package Contents The following items are included in the INVU sensor band™...

  • Page 17: Invu Sensor Band™ Components

    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)
  • Page 18 • 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™.
  • Page 19 Functional indicator (for the On/Off button) Charging port (Charging indicator) Figure 3-4. Controller LEDs location 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. •...
  • Page 20 Know Your INVU Sensor Band ™ INVU Sensor Band™ Components 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.

  • Page 21: Charging The Invu Sensor Band™ Battery

    Note: 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 power it OFF. Remove the band from your body before charging. For additional information see...

  • Page 22: Standard Operation Duration

    The INVU Sensor Band™ has a limited usage duration for standard operation. There is an expiration date mentioned on the INVU by Nuvo™ Packaging Label, and there is a limited number of session hours that the INVU Sensor Band™ can perform.

  • Page 23: First Time Using Invu By Nuvo

    Note: 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 power it OFF. Remove the band from your body before charging as described in section 5.3.
  • Page 24 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. Note: When the LED turns green, it is an indication that the INVU Sensor Band™ is fully charged. Nuvo Group Ltd.

  • Page 25: Installing The Application

    Google Play. Look for the INVU™ App and its logo. The INVU™ App is free-of-charge. Activate the INVU™ App by selecting the icon on your mobile device screen. Logging In Open the application by tapping the INVU™ App icon.

  • Page 26: Onboarding Process

    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 27 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. Power ON the INVU Sensor Band™.
  • Page 28 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 Make sure to complete your training sessions before your first clinical monitoring session. To start training, press Start Training on the app home page. Note: We do not perform any clinical monitoring of you or your baby during training. Note: Once you have completed your first use training, you can initiate additional training sessions from the app's help and support menu.

  • Page 30: 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 31: Initiating A Monitoring Session

    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. Verify your Bluetooth connectivity is enabled on your mobile device and that you have access to the Internet.
  • Page 32 Initiating a Monitoring Session Note: After the band is powered ON, you have twenty five minutes to start a monitoring session. If a monitoring session does not begin within twenty five minutes, the INVU Sensor ™ Band will turn itself off automatically.

  • Page 33: Removing The Invu Sensor Band

    Open the back-buckle straps and hold each back strap in separate hands. Figure 5-4. 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

    Avoid accumulation and drying of gel on the band and its sensors. RINSE DETACHABLE SENSORS Detach the detachable sensors from their connectors. Figure 6-1. Detaching the detachable 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 Note: Every 3 weeks a more extensive cleaning process is required. Please refer to the detailed INVU User Manual located on our website for our full extensive cleaning process https://www.nuvocares.com/help-center Caution: Do not immerse the INVU Sensor Band™ in any liquid. If it is accidentally immersed in liquid, do not power ON the unit.

  • Page 36: Repackaging The Invu Sensor Band

    Repackaging the INVU Sensor Band™ Repackaging the INVU Sensor Band™ To protect the INVU Sensor Band™ and keep it in good operational conditions, repackage the INVU Sensor Band™ after using it and for storage purposes. Clean the band as described in section 6.1 above.
  • Page 37 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: Specifications

    • Internet connection The INVU™ App MUST have access to the Internet, either via a Wi-Fi network and a local router or via a cellular data network and a cellular network operator. It is recommended to use a Wi-Fi network.
  • Page 39 The INVU PRO™ application MUST have access to the Internet, either via a Wi-Fi network and a local router. Notes: In a clinical environment or a large facility, a firewall may block INVU data transmission. Please consult with your local network manager if you fail to use the Wi-Fi communication channel;...

  • Page 40: Troubleshooting

    This section lists issues or observations that you may encounter, the possible cause(s) and recommended actions. Note: 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 https://www.nuvocares.com/help-center. INVU Sensor Band™ Troubleshooting Table 8-1. Band troubleshooting...

  • Page 41: Service/Call Center

    Service/Call center If you experienced any serious incident that has occurred in relation to the medical device Or if you have any questions or issues regarding your INVU Sensor Band™, or using the INVU™ App, please contact Nuvo Group customer support:...

This manual is also suitable for:

Invu-3200Nv-btsh-3000

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