Page 1 User Manual User Manual NV-UMLS-0012 May 2022...
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 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 Recording Blood Pressure Readings ..............60 Updating the INVU Sensor Band™ software ............62 Maintenance ..................64 Inspection Before Use ................... 64 Cleaning the INVU Sensor Band™ ................. 65 Repackaging the INVU Sensor Band™ ..............69 Troubleshooting ..................71 Forgot Password ....................
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 pregnant person’s abdomen. The sensors are attached to the pregnant person’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 Identify how different types of CAUTION packaging can be recycled Use by date Do not wring Single Patient – Do not wash Multiple usages MR Unsafe – keep away from magnetic Medical device resonance imaging (MRI) equipment Nuvo Group Ltd.
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: Adverse Events
• 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.
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
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.
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
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 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
Make sure that one of the indicator lights is lit at all times during a monitoring session. 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 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 The Email and Password fields are mandatory Sign in is available if you have an account and fill your Email and Password Figure 4-1. LOGIN screen Note: Set your initial password via the SET PASSWORD link provided in the welcome email sent to you.
Page 23: Onboarding Process
Figure 4-1. Onboarding screen Connecting Your Device After a short walkthrough process, you will be asked 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 The “NEXT” button becomes active only after Bluetooth is enabled. Press “NEXT”. The “Turn On Your Band” screen appears. Power ON the INVU Sensor Band™, the Controller LED lights up in steady green. Figure 4-3. Turn on your band Press “POWER IS ON”. The Scan QR Code screen appears.
Page 25 First Time Using INVU by Nuvo™ 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 band QR code. Press The “READY TO SCAN” on the app screen.
Page 26 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, “connected” indication appears and the Controller LED lights turns steady Blue. Your band is ready for use.
Page 27 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 28 First Time Using INVU by Nuvo™ Onboarding Process Press to initiate training Figure 4-8. Prepare for training See section 6.6 for details on how training is performed. Nuvo Group Ltd.
Page 29: Using The Invu Sensor Band
Using the INVU Sensor Band™ Applying the INVU Sensor Band™ Follow the 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 the App’s Help screen.
Page 30: Initiating A Monitoring Session
INVU Sensor Band™. Figure 5-1. 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 31 Using the INVU Sensor Band™ 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 32: Removing The Invu Sensor Band
Open the back-buckle straps and hold each back strap in separate hands. Figure 5-3. Opening the band Remove the band from your abdomen. Properly clean the band (see section 7.2.2). Store the INVU Sensor Band™ in its case (see section 7.3) Nuvo Group Ltd.
Page 33: The Invu™ App
INVU™ App is the interface between the INVU by Nuvo™ system and its user—the pregnant person. 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 person’s assigned medical supervisor, located remotely.
Page 34: 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 35 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:...
Page 36 The INVU™ App App Screens and Features Figure 6-3. Home screen (monitoring is blocked) No scheduled session right now According to your personalized scheduling, you have no scheduled session right now. Check back during your scheduled session time. Blockage reason...
Page 37 Invu by Nuvo™User Manual The INVU™ App Gestational age is below week 32 Your gestational age is below the prescribed gestational age for monitoring. Blockage reason Grey colored background illustration ’PREPARE FOR MONITORING’ is not available Figure 6-5. 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 care...
Page 38 The INVU™ App App Screens and Features The care plan is no longer active Your care plan is no longer active. Contact your care team for more details. Blockage reason Grey colored ’PREPARE FOR background MONITORING’ is not illustration available Figure 6-7.
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 6-4. 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...
Page 42: Training Session
Training Session Training Session To start training as part of your first use of INVU by Nuvo™ press the “PREPARE FOR TRAINING” button from your Home screen. If the app is disconnected from the band, “Turn on your band” screen will appear. After pressing “POWER ON”...
Page 43 Note: You may initiate additional training sessions from the Help and support menu. If the number of allowed training sessions reaches its limit, a relevant notification is shown. Please contact Nuvo’s customer service if additional training is required. NV-UMLS-0012...
Page 44 The INVU™ App Training Session Tap to open the help center Tap to start a training session Tap to chat with support Figure 6-12. Help and support Nuvo Group Ltd.
Page 45 INVU Sensor Band™ and are described in detail in section 6.5.1. After following the preparation guidelines and applying the INVU Sensor Band™, press “WI- FI ENABLED” on the last session preparation guidelines screen. The “all set” screen is shown and pressing “START TRAINING SESSION”...
Page 46 The INVU™ App Training Session ✓ Avoid initiating or answering phone calls or the use of any highly consuming internet bandwidth applications of your smartphone during the training session. Note: The training session can take up to 15 minutes. Note: To learn how to handle errors occurring during the training session, see the troubleshooting section.
Page 47 Invu by Nuvo™User Manual The INVU™ App Band Signal Testing Results During the training session, we test the signal received from your INVU Sensor Band™. If the band’s signal is good, a “GOOD SIGNAL” message appears and testing of the band signal continues.
Page 48 The INVU™ App Training Session Press “WALK ME THROUGH IT” to view and follow instructions Figure 6-16. Weak signal result Press the buttons to Press “READY TO TRY Swipe left to view view the next AGAIN” to resume the previous...
Page 49 Invu by Nuvo™User Manual The INVU™ App Figure 6-18. Signal improved NV-UMLS-0012...
Page 50 The INVU™ App Training Session Stopping the Training Session The training session is automatically stopped once it reaches the minimum number of minutes with a good band signal. The training session can also be manually stopped at any point. Once successfully completed, the “YOU DID IT!” screen will be shown. Pressing “DONE” will return the user to the home screen with the updated number of the training sessions performed.
Page 51: 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 52 The INVU™ App Starting a Monitoring Session Session Preparation Guidelines The session preparation guidelines will guide you how to prepare and wear your INVU Sensor Band™. The guidelines include step-by-step instructions with animations and voice narration. Note: Make sure your phone’s volume is up, as the session preparation screens include voice narration.
Page 53 Prepare your INVU Sensor Band™ Place the INVU Sensor Band™ on a flat surface and release each strap. Leave the buckles open. Use 8 of the 10 detachable sensors provided and attach them to their spots on the band.
Page 54 It’s important to make the size adjustments before applying the gel to avoid smearing. Hold the INVU Sensor Band™ to your belly and close the back buckle. If the back buckles don’t meet, slide them away from the side plastic pods to loosen the band before buckling it.
Page 55 After watching all the steps, you’ll be asked to put on your band accordingly: Stand up and hold the band by its side plastic pods. Make sure the INVU logo is on the top, in front of the center of your belly, and facing out.
Page 56 The INVU™ App Starting a Monitoring Session Figure 6-27. Wear the band instructions Nuvo Group Ltd.
Page 57 Figure 6-28. Monitoring position instructions Starting a session The monitoring session process can start after following the preparation guidelines and applying the INVU Sensor Band™. Press “START MONITORING SESSION” to start the session setup process. Figure 6-29. All set NV-UMLS-0012...
Page 58 ✓ 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 59 Invu by Nuvo™User Manual The INVU™ App Figure 6-30. Setup in progress In case you encounter a problem during the setup, you can press the help icon and chat with our customer support team. Figure 6-31. In-app support chat When the session setup process completes successfully, a countdown screen appears, ending with the “YOU’RE GOOD TO GO!”...
Page 60 The INVU™ App Starting a Monitoring Session Session elapsed time (including the last minute from the session setup) Total session duration as prescribed by the care team team Figure 6-32. Session setup completed Note: In case of a process failure, see troubleshooting section 8.3 on page 58.
Page 61 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. View Press to contact messages support from your care team Press X to stop the...
Page 62 The INVU™ App Starting a Monitoring Session Tap to open a chat with support Tap to start a new conversation with support Figure 6-34. Chat with support during a monitoring session Note: It is not recommended to manually stop a session. The session ends automatically once it reaches the prescribed duration.
Page 63 Invu by Nuvo™User Manual The INVU™ App 6.5.3.1 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 session setup process) and the session elapsed time (including the last minute collected during the session setup process).
Page 64 The INVU™ App Starting a Monitoring Session 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. The session can also be manually stopped at any point by quitting the session; however, it is not recommended.
Page 65 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 66: Recording Blood Pressure Readings
The INVU™ App Recording Blood Pressure Readings Recording Blood Pressure Readings Blood pressure readings may be recorded following the completion of a session or from the Blood pressure trends screen. Recording is available only if it is part of your care plan prescribed by your provider.
Page 67 Invu by Nuvo™User Manual The INVU™ App Take one blood pressure reading and record your readings. It is recommended to wait at least 1 minute between blood pressure readings. You might be asked to measure it twice. Record Your Blood Pressure Readings Record your first reading by adding the systolic value and then the diastolic value in the proper place.
Page 68: Updating The Invu Sensor Band™ Software
Figure 6-32. Blood pressure trends Updating the INVU Sensor Band™ software The INVU Sensor Band™ software may require an update from time to time to include new features and improvements. When the INVU App™ connects to the INVU Sensor Band™ and detects that a software update is required, “Your sensor band needs a quick update”...
Page 69 The INVU™ App While updating is in progress keep your phone near your sensor band, and don’t close the INVU App™. In the case that the app was closed during the process, load the app again and the update process shall continue.
Page 70: Maintenance
This section describes how to maintain the INVU Sensor Band™. Inspection Before Use 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 71: Cleaning The Invu Sensor Band
Cleaning the INVU Sensor Band™ Cleaning Before Use Wipe the INVU Sensor Band™ with CaviWipes™ wipes or equivalent, removing all gel residues. If an excessive amount of gel was applied on the sensor, wipe the excess gel that overflows the cavity with CaviWipes™ wipes or equivalent.
Page 72 Maintenance Cleaning the INVU Sensor Band™ Power OFF the band by a long press on the power button. (see “Powering OFF the INVU Sensor Band™” in section 3.2.1). Remove the band (see “Removing the INVU Sensor Band™” in section 5.3).
Page 73 If the device does not appear to be clean at the end of this process, repeat the process. Caution 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 via the support chat in the app or at support@nuvocares.com...
Page 74 Maintenance Cleaning the INVU Sensor Band™ 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 75: 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 7.2 above.
Page 76 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 77: 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 78 Grant the requested permissions (Bluetooth, Location or Camera). Restart the application. Note: If a problem persists, please contact Nuvo Group customer support via the support support@nuvocares.com chat in the app or at or at 1-800-554-9041 (USA only). Nuvo Group Ltd.
Page 79: Monitoring Session Troubleshooting
Invu by Nuvo™User Manual Troubleshooting Monitoring Session Troubleshooting Table 8-2. Monitoring session problems System Errors Cause Recommended Actions Poor signal quality One or more of the band If poor signal quality messages issues sensors is not properly appear while monitoring,...
Page 80 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 81 Invu by Nuvo™User Manual Troubleshooting System Errors Cause Recommended Actions exhausted, or there is no Restart your Wi-Fi router or access to Internet check your cellular data plan. connectivity via Wi-Fi. Restart the session. If the problem persists, please contact customer support via the support chat in the app or at support@nuvocares.com...
Page 82 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 83 1-800- 554-9041 (USA only). Note: If a problem persists, please contact Nuvo Group customer support via the support support@nuvocares.com chat in the app or at or at 1-800-554-9041 (USA only). NV-UMLS-0012...
Page 84: General Troubleshooting
Your phone’s battery level If your phone's battery is too low to is too low cannot be low when start a session, charge your phone starting a monitoring so the battery level is higher than session. 50%. Nuvo Group Ltd.
Page 85 Invu by Nuvo™User Manual Troubleshooting Note: If a problem persists, please contact Nuvo Group customer support via the support support@nuvocares.com chat in the app or at or at 1-800-554-9041 (USA only). NV-UMLS-0012...
Page 86: Invu Sensor Band™ Troubleshooting
1-800- 554-9041 (USA only). Note: If a problem persists, please contact Nuvo Group customer support via the support support@nuvocares.com chat in the app or at or at 1-800-554-9041 (USA only). Nuvo Group Ltd.
Page 87: 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: •...
Page 88: 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 89: System Specifications
• Lower strip length: 42–62 cm (16.5-24.5 inches) Band physical dimensions • Back-strap length: 25–109 cm (10 –43 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 90 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 91 Invu by Nuvo™User Manual Specifications Electricity Symbol / Parameter Typical Units Notes Function Battery 1,00 Rechargeable Li-Ion-Po, Battery 1,100 capacity single cell Battery VBATT Dependent operating state voltage At monitoring Power Power on- standby (no consumption 0.33 monitoring) Operating Hrs.
Page 92 1024 IEEE 802.15 Class 2 Bluetooth® Standard Connectivity module with on-board dielectric chip antenna Range Profile Connectivity SPP or iAP2 Data Rate kbps Data collection interval Signal processing time Signal FECG Processing detection threshold FPCG detection threshold Nuvo Group Ltd.
Page 93 INVU Sensor Band™ is compliant with IEC 60601-1-2:2014. However, due to the proximity to other equipment compliant with less strict standards, the INVU Sensor Band™ can be the victim of electromagnetic interference (EMI), resulting in a degradation in device performance..
Page 94 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 by the Nuvo cloud is MHR, FHR and UA. 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 95 Synthetic Rubber, Polyester, 80% Polyamide / 20 % elastane, PU, Thermoplastic Polyurethane Ester Grade, TPU composite film, Nylon / AgCl, TPE - TM4ADT, 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 96: Appendices
60601-1-2:2014 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 97 Invu by Nuvo™User Manual Appendices Table 10-2. System Compliance Information – Enclosure Port Immunity to RF Wireless communications equipment. Services for which the recommended separation distance is 0.3 m (12 inches) Test Immunity Compliance Band Service Modulation Frequency Level Level...
Page 98 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 99 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 100 For this reason, an additional factor of 10/3 has been incorporated into the formulae used in calculating the recommended separation distance for transmitters in these frequency ranges. Nuvo Group Ltd.
Page 101 Invu by Nuvo™User Manual Appendices Radiated immunity to radiofrequency electromagnetic field Immunity IEC 60601 Test Level Compliance Level Electromagnetic Environment Test Guidance IEC 61000-4- 10 V/m 10 V/m d=1.2 √�� 80 MHz to 800 3:2010 80 MHz to 2.7 GHz 80 MHz to 2.7 GHz...
Page 102 Nuvo™ System is operated at least 30 cm away from RFID reader, storage closets and supply units. If an RFID system is placed within close proximity to the INVU by Nuvo™ System and the system is affected by the RFID system, it would be necessary to take mitigating actions such as relocating the RFID system or moving away from the RFID transmitter before starting the operation of the INVU by Nuvo™...
Page 103: Appendix B. Benefit Summary
Invu by Nuvo™User Manual Appendices Appendix B. Benefit Summary Benefit Magnitude Rationale of Benefit a significant improvement over the existing standard of care, with many immediate and critical benefits, Remote pregnancy High monitoring such as the ability to monitor women in remote/rural...
Page 104 While this benefit is important, a remote system can still function without it. Thus the benefit is classified as ‘medium’ Table 10-5. INVU System NV-INVU-3200 Benefit - Summary Nuvo Group Ltd.

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