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Nuvo invu User Manual

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User Manual
User Manual
NV-UMLS-0001
July 2020

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  • Page 1 User Manual User Manual NV-UMLS-0001 July 2020...
  • Page 2 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 affiliates in the United States and/or other countries.
  • Page 3 Accordingly, the content in this user manual does not and will not form part of any contract between Nuvo Group and any user of INVU by Nuvo™. No person has the authority to bind Nuvo Group to any representation or warranty except as either specifically set forth above and/or in the INVU by Nuvo™...
  • Page 4 About this Manual Conventions © 2020 Nuvo Group Ltd. All rights reserved. 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 affiliates in the United States and/or other countries. All other company or product names are the trademarks or registered trademarks of their respective holders.

  • Page 5: Table Of Contents

    Invu by Nuvo™User Manual Table of Contents Table of Contents Introduction .................... 1 Proper Use of INVU by Nuvo™ and this Manual ............. 1 INVU by Nuvo™ Overview ..................1 INVU by Nuvo™ Technology..................2 Labels and Symbols ....................3 Safety ......................
  • Page 6 Table of Contents Maintenance ..................48 Cleaning the INVU Sensor Band™ ................. 48 Repackaging the INVU Sensor Band™ ..............51 Troubleshooting ..................53 Forgot Password ....................53 INVU Sensor Band™ Connectivity Troubleshooting..........53 Monitoring Session Troubleshooting ..............55 General Troubleshooting ..................60 INVU Sensor Band™...

  • Page 7: Introduction

    User Manual. • 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 8: 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 that 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™...

  • Page 9: Labels And Symbols

    Invu by Nuvo™User Manual Introduction Labels and Symbols 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.
  • Page 10 Handle with care Humidity limitation RoHS2 Class II WARNING Identify how different types of CAUTION packaging can be recycled Use by date Do not dry clean Do not wring Do not wash Single Patient – Medical device Multiple usages Nuvo Group Ltd.

  • Page 11: Safety

    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.

  • 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 critical care situations or in laboring patients or those patients hospitalized for or suspected to have preterm labor. •...

  • Page 13: General Warnings And Cautions

    NEVER try to replace the rechargeable battery! • 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

    8.1 which defined the maximum power of the wireless equipment and its minimum distance to the INVU Sensor Band™ at which the INVU Sensor Band™ functionality stays steady. Thus, the minimum distance of 0.3m to some RF communicating device can be recommended as the separation distance for The INVU Sensor Band™.

  • Page 15: 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 device. Always look for the expiration date on the INVU Sensor Band™ Packaging Label. INVU Sensor Band™ Package Contents The following items are included in the INVU Sensor Band™...

  • Page 16: Invu Sensor Band™ Components

    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. 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 17 • 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 18 Know Your INVU Sensor Band™ INVU Sensor Band™ Components 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 19: Charging The Invu Sensor Band™ Battery

    Invu by Nuvo™User Manual Know Your INVU Sensor Band™ 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 20: Standard Operation Duration

    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. The INVU Sensor Band™ can be used until its expiry date is reached or until it reaches its maximum number of sessions; whichever comes first.

  • Page 21: First Time Using Invu By Nuvo

    Google Play. Look for 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 22 First Time Using INVU by Nuvo™ Logging In Press Sign In. The app terms of use screen is displayed. Read carefully and press “accept and continue” to accept the terms of use. After accepting, the app privacy policy screen appears. Read carefully and press “accept and continue” to accept the policy and to continue to the next step.

  • Page 23: Connecting Your Device

    First Time Using INVU by Nuvo™ Connecting Your Device After a short walkthrough process, you will be requested to connect your INVU Sensor Band™ to your account. Connecting your device will be done by scanning the QR code located on your band.

  • Page 24: Connecting Via Qr Code Scan

    Connecting via QR Code Scan 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 25 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 26 First Time Using INVU by Nuvo™ Connecting via QR Code Scan Figure 4-7. System message after pairing completion Note: After the band connection is established, you have fifteen minutes to start a monitoring session. If a monitoring session is not initiated within these fifteen minutes, the band will turn itself off automatically.

  • Page 27: Using The Invu Sensor Band

    ADJUSTING THE BAND TO YOUR SIZE Unlock the front buckles and release the front and back straps. Flip the band over. Note the top and bottom indicators. The INVU by Nuvo™ logo should be at the top front of the strip.
  • Page 28 Using the INVU Sensor Band™ Applying the INVU Sensor Band™ Figure 5-3. Closing the back straps Before letting go, adjust the band by pulling both back straps to the sides simultaneously, then pull each strap separately to tighten. Figure 5-4. Adjusting the back straps Verify the upper strap is placed above the abdomen and below the breasts, and that the lower strip is placed under the abdomen.
  • Page 29 Invu by Nuvo™User Manual Using the INVU Sensor Band™ Figure 5-5. Pulling the front adjustment straps Once the belt is properly fitted, use the front buckles to lock the straps in place. REMOVING THE SENSOR BAND Open the buckle of the back-straps and hold each back strap in separate hands.
  • Page 30 Applying the INVU Sensor Band™ APPLYING GEL Place the INVU Sensor Band™ on a flat surface (like a table), with the sensors facing upwards (see Figure 5-7). Apply the gel provided in the package to all 8 detachable sensors: three on the upper strip of the band, three on the lower strip, and one on each side of the band.
  • Page 31 The lateral units should be located on the sides as backward as possible. ▪ The INVU by Nuvo™ logo is on the upper frontal strip of the INVU Sensor Band™. MOVING TO THE MONITORING POSITION Monitoring sessions are best performed in a comfortable relaxed position while lying down on the back, sitting, or reclining in a quiet room.

  • Page 32: Initiating A Monitoring Session

    INVU Sensor Band™. Figure 5-9. 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 33 Invu by Nuvo™User Manual Using the INVU Sensor Band™ The session will stop automatically after reaching the duration prescribed by your medical care team (up to 5 minutes). NV-UMLS-0001...

  • Page 34: Removing The Invu Sensor Band

    Open the back-buckle straps and hold each back strap in separate hands. Figure 5-10. Opening the band Remove the band from your abdomen. Properly clean the band (see section 7.1.2). Store the INVU Sensor Band™ in its case (see section 7.2) Nuvo Group Ltd.

  • Page 35: The Invu™ App

    INVU™ App is the interface between the INVU by Nuvo™ system and its user—the pregnant woman. It allows the user to log into the INVU™ App, start and control a monitoring session and view its results in near real-time. The session data will be shared with the pregnant woman’s assigned medical supervisor, located remotely.

  • Page 36: App Screens And Features

    The INVU™ App App Screens and Features App Screens and Features The following section describes the operational methodology of the INVU™ App. Main Menu The main menu is accessed from each main screen. Press the main menu icon to open the main menu.
  • Page 37 Invu by Nuvo™User Manual The INVU™ App Home Screen The Home screen is the first screen that is displayed after logging in to the application. Pressing Home opens the home screen, which enables starting a monitoring session and viewing your care plan usage (see section 6.3.5), may display different states: Monitoring session is permitted A monitoring session can be started according to your schedule.
  • Page 38 The INVU™ App App Screens and Features Gestational age is below week 34 Your gestational age is below the prescribed gestational age for monitoring. Blockage reason Grey colored circles Start monitor is disabled Figure 6-4. Home screen (monitoring is blocked) The care plan is completed You’ve completed your care plan! If you wish to extend the plan, please contact your...
  • Page 39 Invu by Nuvo™User Manual The INVU™ App Timeline Pressing Timeline opens the Timeline screen. Date and pregnancy trimester Future days Monitoring session performed today Today pointer Past days Figure 6-6. Timeline screen The timeline is a calendar with all the information related to you and your baby. It includes standard test recommendations, performed monitoring sessions, and blood pressure tests.
  • Page 40 Your care plan is automatically enforced via the INVU app. • Care team – pressing on the care team will display your clinic details and your care team members' details. • Pregnancy trends – presents graph trends of measurements taken via the INVU app. Nuvo Group Ltd.
  • Page 41 • Rescan the band's QR code for pairing with a new band or after a scan failure. Logout Pressing Logout logs out of the INVU™ App. The LOGIN screen appears. The Logout button is enabled from the main menu. Help Pressing Help on the app main menu enables you access to educational materials, such as: •...

  • Page 42: Starting A Monitoring Session

    If the number of sessions reached its limit, a notification that the number of sessions exceeded its limit will be displayed after the INVU™ App and band pairing process. Please contact Nuvo’s customer service in the occurrence of such an event.
  • Page 43 Invu by Nuvo™User Manual The INVU™ App Session Preparation Guidelines Video tutorial - The session preparation guideline starts with a short video tutorial. Watching the video is mandatory for first-time use. Figure 6-10. Video tutorial After watching the video to its end, the “CONTINUE” button becomes enabled. Press “CONTINUE”...
  • Page 44 The abdominal skin surface must be cleaned from oils/ointments/creams before placing the INVU Sensor Band™ on the skin. If a residual cream/oil/ointment remains on the skin in the area of the sensor, there might be difficulties with detecting the heart rate signals.
  • Page 45 Invu by Nuvo™User Manual The INVU™ App Press to view detailed instructions Figure 6-13. Sensor band placement Swipe left to continue to the next instruction. Connect to Wi-Fi network (4 screen) - Verify that your Wi-Fi is turned on and that your mobile device is connected to Wi-Fi.
  • Page 46 Figure 6-15. Find a comfortable position The monitoring session process can start after following the preparation guidelines and applying the INVU Sensor Band™. Press “START SESSION” to start the signal quality check process. Starting the Signal Quality Check The Signal Quality Check process can begin after following the session preparation guidelines and applying the INVU Sensor Band™.
  • Page 47 Invu by Nuvo™User Manual The INVU™ App Note: The signal quality check can take up to 6 minutes and the successful last minute is included in the monitoring session duration. Note: During the Signal quality check and the monitoring session, avoid changing the mobile device localization setting.
  • Page 48 The INVU™ App Starting a Monitoring Session Note: In case of a process failure, see troubleshooting section 8.3 on page 58. Nuvo Group Ltd.
  • Page 49 Invu by Nuvo™User Manual The INVU™ App Monitoring Session At the beginning of the first session, an Indication popup appears, explaining the use of each button. Press to report kicks Press to mute the fetal simulated heartbeat sound Figure 6-18. Monitoring in session screen The following buttons are available: •...
  • Page 50 The INVU™ App Starting a Monitoring Session Figure 6-19 Possible delay in completing a session banner Nuvo Group Ltd.

  • Page 51: Monitoring Cards

    Invu by Nuvo™User Manual The INVU™ App Monitoring Cards The Baby monitoring card displays a numeric value of the Baby heart rate (an average of the entire session excluding minutes that did not pass the signal quality check process) and the session elapsed time (including the last minute collected during the signal quality check process).
  • Page 52 The INVU™ App Monitoring Cards Stopping the Monitoring Session Monitoring sessions are automatically stopped once the session reaches the duration prescribed by your caregiver and according to your care plan (up to 5 minutes). The session can also be manually stopped at any point; however, it is not recommended.
  • Page 53 Invu by Nuvo™User Manual The INVU™ App Session Summary The session summary screen is displayed after a monitoring session ends or is stopped, by pressing SESSION SUMMARY on the Session Completed screen. The session summary screen displays the following information: •...

  • Page 54: Maintenance

    It is very important to clean the band immediately after completing a monitoring session. Avoid accumulation and drying of gel on the band and its sensors. Power OFF the band by a long press on the power button. (see “Powering OFF the INVU Sensor Band™” on page 11).
  • Page 55 Invu by Nuvo™User Manual Maintenance Note: We recommend using at least 4 wipes in each step that requiring wiping with wipes. Clean the inner side of the band (the part facing the abdomen), including the Acoustic sensors and the detachable sensor, with at least 4 CaviWipes™ wipes or equivalent.
  • Page 56 1-800-554-90411-800-554-9041 (USA only). Caution Do not use a hot air blower or machine dryer, and do not place INVU Sensor Band™ on or near hot surfaces. Caution INVU Sensor Band™ does NOT have any user-serviceable parts. Do not open the Controller.

  • Page 57: Repackaging The Invu Sensor Band

    Maintenance 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 7.1 above.
  • Page 58 Maintenance Repackaging the INVU Sensor Band™ 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 (see following section 9.3.1). Nuvo Group Ltd.

  • Page 59: Troubleshooting

    QR Code Scan Failed! Scanned QR code is not an Make sure that you are scanning INVU sensor band QR code the QR code located on the INVU or is corrupted. Sensor Band™. Try to scan the QR code again.
  • Page 60 Settings. Grant the requested permissions (Bluetooth, Location or Camera). Restart the application. Note: If a problem persists, please contact Nuvo Group customer support at support@nuvocares.com or at 1-800-554-9041 (USA only). Nuvo Group Ltd.

  • Page 61: Monitoring Session Troubleshooting

    Press CONTINUE. If this message appears after a failed monitoring attempt: Remove the INVU Sensor Band from your abdomen. Add gel to the detachable sensors. Scrub your full abdominal skin with water and soap and towel dry it.
  • Page 62 The sensor band is not properly attached to the abdomen. INVU Sensor Band Data transfer problem Verify the INVU Sensor Band and Connectivity Problem between the mobile device mobile device are close and and the sensor band during within Bluetooth range: less than the session.
  • Page 63 Invu by Nuvo™User Manual Troubleshooting System Errors Cause Recommended Actions to the server and the session will continue. If the Internet connectivity is not restored within those 5 minutes the session will fail with an error. Server Is Offline or Check your Internet connection.
  • Page 64 If the problem persists, please contact customer support at support@nuvocares.com or 1-800- 554-9041 (USA only). INVU Sensor Band The INVU Sensor Band was Turn the sensor band Off and Internal Error. turned Off due to a back On. technical issue.
  • Page 65 Restart the session. session. If the problem persists, please contact customer support at support@nuvocares.com or 1-800- 554-9041 (USA only). Note: If a problem persists, please contact Nuvo Group customer support at support@nuvocares.com or at 1-800-554-9041 (USA only). NV-UMLS-0001...

  • Page 66: General Troubleshooting

    Enable automatic synchronized. synchronization of date and time on the device. Press TRY AGAIN. Note: If a problem persists, please contact Nuvo Group customer support at support@nuvocares.com or at 1-800-554-9041 (USA only). Nuvo Group Ltd.

  • Page 67: Invu Sensor Band™ Troubleshooting

    The INVU Sensor Improper use/storage/on Contact Nuvo Group customer Band™ is damaged. arrival. support at: support@nuvocares.com or 1-800- 554-9041 (USA only). Note: If a problem persists, please contact Nuvo Group customer support at support@nuvocares.com or at 1-800-554-9041 (USA only). NV-UMLS-0001...

  • Page 68: Service/Call Center

    Troubleshooting Service/Call Center 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). Nuvo Group Ltd.

  • Page 69: 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 70: System Specifications

    Band physical dimensions • Back-strap length: 25– 93 cm (10 –36.5 inches) The INVU Sensor Band™ is a one-size band that fits most Pregnancy size maternity sizes: S, M, L, XL, 1X, 2X, 3X (up to 160 kg or 353 pounds).
  • Page 71 INVU Sensor Band and INVU App do not allow multiple connections on the Bluetooth Interface. The connection between the mobile and the INVU sensor band is one to one and the full bandwidth is dedicated to transmitting the patient data. The Bluetooth interface allows data transmission up to 800kbps for Android devices and up to 250kbps for iAP devices.
  • Page 72 Input signal +0.1 -0.15 range BFEM PGA gain CMRR -120 ADC resolution ADC data rate 1,000 Number of Acoustic sensors sensors Transducer Electret Condenser Microphone type Microphone Acoustic Sensitivity Sensors @1kHz Microphone S/N ratio @1KHz Nuvo Group Ltd.
  • Page 73 Invu by Nuvo™User Manual Specifications Symbol / Parameter Typical Units Notes Function A frequency response below 10Hz is typically Frequency achievable; however, their 1000 range non-constant response and one device can significantly differ one from another. Input signal -0.6 +0.6...
  • Page 74 INVU Sensor Band™ is compliant with IEC 60601-1-2. However, due to the proximity to other equipment compliant with less strict standards, the INVU Sensor Band™ can be the victim of Electro-Magnetic Interference (EMI) which could generate a degradation in the device performance.
  • Page 75 Performance-Collateral—Standard: Electromagnetic disturbances—Requirements and tests. INVU Sensor Band™ is a data acquisition device providing sensory data to the Nuvo Cloud system. The data provided to the Nuvo cloud is MHR and FHR. The device range for MHR is 50 to 210 bpm, and for FHR it is 50 to 250 bpm. For both parameters, the expected error is less than 10%.
  • Page 76 Rubber, Polyester, 80% Polyamide / 20 % elastane, PU, Thermoplastic Polyurethane Ester Grade, TPU composite film, Nylon / AgCl, Silicon, PVC (wire). Maternity Sizes The INVU Sensor Band™ is a one-size band that fits most maternity sizes (S-3X), as defined in the below table. Pregnancy...

  • Page 77: Appendices

    60601-1-2 standards. The INVU by Nuvo™ System is intended for use in the electromagnetic environment specified below. The customer or the user of the INVU by Nuvo™ device should ensure that it is used in such an environment. Table 10-1. System Compliance Information – Electromagnetic Emissions The INVU by Nuvo™...
  • Page 78 The carrier shall be modulated using a 50 % duty cycle square wave signal. c) As an alternative to FM modulation, 50 % pulse modulation at 18 Hz may be used because while it does not represent actual modulation, it would be the worst case. Nuvo Group Ltd.
  • Page 79 The INVU by Nuvo™ system is intended for use in the electromagnetic environment specified below. The customer or the user of the INVU by Nuvo™ Interface should assure that it is used in such an environment. IMMUNITY test Test level Compliance level Electromagnetic environment –...
  • Page 80 The INVU by Nuvo™ system is intended for use in the electromagnetic environment specified below. The customer or the user of the INVU by Nuvo™ Interface should assure that it is used in such an environment. IMMUNITY test Test level Compliance level Electromagnetic environment –...
  • Page 81 Invu by Nuvo™User Manual Appendices Conducted immunity to disturbances induced by radio frequency field Immunity IEC 60601 Test Level Compliance Level Electromagnetic Test Environment Guidance d=0.58 √�� IEC 61000-4-3 Frequency 80–2700 Frequency 80–2700 range: range: d=1.2 √�� d=1.2 √�� 80 MHz to 800...

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