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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 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.

  • 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™ Charging INVU Sensor Band™ Installing the Application Logging In Connecting Your Device Connecting via QR Code Scan...
  • 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 and MHR 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: 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 10: Limitation Of Use

    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.

  • Page 11: Adverse Events

    • 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. • INVU by Nuvo™ is not to be used for antepartum monitoring (i.e., non-stress testing).

  • Page 12: Invu By Nuvo™ Usage Restrictions

    Do not use the INVU Sensor Band™ after its expiration date. • • When the charging LED turns green it is an indication that the INVU Sensor Band™ is fully charged. Avoid leaving the system plugged in for more than 4 hours or when the LED turns green; whichever comes first.

  • Page 13: Regulatory Classification

    • Any other potential exposure to a strong electromagnetic field. Regulatory Classification The INVU by Nuvo™ system, including the INVU™ App, is classified as Class II (US). Complying with Standards The INVU Sensor Band™ was approved as per IEC 60601-1-2, which contains tests of immunity to proximity RF fields of different RF wireless communication equipment.

  • Page 14: Know Your Invu Sensor Band

    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 Description Carrying case INVU Sensor Band™...

  • Page 15: Invu Sensor Band™ Components

    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) Item Description Rear closing strap with a buckle Detachable (bio-potential) sensors (×8)
  • Page 16 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 17 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™. WARNING Functional indicator (for the On/Off button) Charging port (Charging indicator) Figure 3-4.
  • Page 18 Make sure that one of the indicator lights is lit at all times during a monitoring session. NOTE 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™...

  • Page 19: First Time Using Invu By Nuvo

    However, it is recommended recharging to a fully charged battery before first use. 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 20: Installing The Application

    Remove the INVU Sensor Band™ from your body before connecting the cable for charging! Do NOT charge the battery while the INVU Sensor Band™ is worn. WARNING Insert the USB type-C plug of the supplied power supply to the Micro USB charging socket at the side of the plastic controller.

  • Page 21: Connecting Your Device

    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. The INVU™ App requests you to enable Bluetooth and Wi-Fi on your...

  • Page 22: Connecting Via Qr Code Scan

    Press Connect. The Scan QR Code screen appears. 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 23 Power ON the INVU Sensor Band™. The Controller LED lights up in steady green (see Figure 3-4). Press Scan QR on the app screen. Press to close Press to scan the belt QR- code Figure 4-4. Scan QR Code screen A message requesting permission for the QR scanner application to access your camera and location services may appear.
  • Page 24 Figure 4-6. Band QR code Point your mobile device camera at the QR code, located on the plastic cover of the INVU Sensor Band™ controller. QR code location Figure 4-7. QR Code location Make sure the camera is focused on the QR code; if necessary, tap on the screen to enable camera focusing on the QR code.
  • 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: 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 27 Figure 5-2. Positioning the INVU Sensor Band™ (note the logo at the top) Slide your hands along the back strap and secure it by closing the back buckle. You should hear a click sound (see Figure 5-3). 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.
  • Page 28 Verify the upper strap is placed above the abdomen and below the breasts, and that the lower strip is placed under the abdomen. To tighten the band, unlock the front buckles and pull the front adjustment straps until the band is properly attached to the skin and is stable on the abdomen.
  • Page 29 Step 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 30 Now that the band is adjusted to your size you can easily put it on. Hold the band side plastic parts and wear the band, as instructed in STEP 1. When properly positioned on the abdomen, the INVU Sensor Band™ should look as shown below.

  • Page 31: Initiating A Monitoring Session

    • 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™. Step 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 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 (see section 3.2.1 for reference). Verify your Bluetooth connectivity is enabled on your mobile device and that you have access to the Internet.
  • Page 33 The INVU Sensor Band™ transfers data to the mobile application Bluetooth communication. You should be near your mobile device at a distance that does not exceed 5 meters NOTE (about 16 feet), and there should be no walls in between.

  • Page 34: Removing The Invu Sensor Band

    Open the back-buckle straps and hold each back strap in separate hands. Figure 5-11. Opening the Belt 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 35: 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 36: 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 37 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 38 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 39: 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 40: Monitoring Session Troubleshooting

    The band is storage/on support at: support@nuvocares.com damaged. arrival. or 1-800-554-9041 (USA only). 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 41 INVU Press CONTINUE. Sensor If this message appears after Band™ a failed monitoring attempt: Attachment Remove the INVU Sensor Problem. Band™. from your abdomen. Add gel to the detachable sensors. Scrub your full abdominal skin with water and soap and towel dry it.
  • Page 42 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 43 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 44 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 45 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. Disconnect the INVU Sensor Band™ from the charger.

  • Page 46: 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).

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