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Nuvo INVU User Manual Download Page 10

Introduction 
Labels and Symbols 
 

4 

Nuvo Group Ltd. 

Symbol 

Description 

Symbol 

Description 

 

Do not use if the 
package is damaged 

 

Prescription-only 

 

Keep away from 
sunlight 

IP22 

Degree of protection 
against ingress of water 
provided 

 

Keep dry 

 

Handle with care 

 

Humidity limitation 

 

RoHS3 

 

Class II 

 

WARNING 

 

Identify how 
different types of 
packaging can be 
recycled 

 

CAUTION 

 

Use by date 

 

Do not wring 

 

Do not wash 

 

Single Patient 

–

 

Multiple usages 

 

Medical device  

 

MR Unsafe 

–

 keep 

away from magnetic 
resonance imaging 
(MRI) equipment 

 

Summary of Contents for INVU

Page 1: ...NV UMLS 0012 May 2022 User Manual User Manual...

Page 2: ...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 t...

Page 3: ...in the applicable limited warranty which is contained in the INVU by Nuvo User Agreement or as mandated by applicable law Without limiting the foregoing Nuvo Group makes no warranty of any kind in re...

Page 4: ...ols have been inserted on the left hand side of this manual for more comprehensive user experience Symbol Description Note Information given in a note symbol provides information that is useful to kno...

Page 5: ...Know Your INVU Sensor Band 9 3 1 INVU Sensor Band Package Contents 9 3 2 INVU Sensor Band Components 10 3 3 Charging the INVU Sensor Band Battery 13 3 4 Standard Operation Duration 14 4 First Time Us...

Page 6: ...69 8 Troubleshooting 71 8 1 Forgot Password 71 8 2 INVU Sensor Band Connectivity Troubleshooting 71 8 3 Monitoring Session Troubleshooting 73 8 4 General Troubleshooting 78 8 5 INVU Sensor Band Troub...

Page 7: ...nitoring system that provides continuous passive monitoring of vital pregnancy data of the pregnant person and the fetus through the INVU App The information it provides is Fetal heart rate FHR Matern...

Page 8: ...n by a uniquely designed band INVU Sensor Band which transmits the measured data via cloud based algorithms to a server that processes the measured data for near real time pregnancy status monitoring...

Page 9: ...ative when applicable Manufacturer FCC ID S9NSPBT30DP2 Catalog number GMDN Fetal Cardiac Monitor 43958 when applicable Serial number UMDNS Monitors Bedside Fetal Antepartum 18339 18340 when applicable...

Page 10: ...m sunlight IP22 Degree of protection against ingress of water provided Keep dry Handle with care Humidity limitation RoHS3 Class II WARNING Identify how different types of packaging can be recycled CA...

Page 11: ...This system does not prevent the onset of preterm labor nor will it prevent the occurrence of preterm birth 2 2 Contraindications INVU Sensor Band should not be used by pregnant people who meet one or...

Page 12: ...ternal 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 pr...

Page 13: ...oes not require another adjacent or stacked device for normal operation The use of this equipment adjacent to or stacked with other equipment should be avoided as it might result in improper operation...

Page 14: ...ent RF wireless communication equipment The test was implemented in accordance with clause 8 1 which defined the maximum power of the wireless equipment and its minimum distance to the INVU Sensor Ban...

Page 15: ...ems are included in the INVU Sensor Band packaging Figure 3 1 INVU Sensor Band package contents Item Description 1 Carrying case 2 INVU Sensor Band 3 Medical grade power supply and charging cable 4 EC...

Page 16: ...er button a rechargeable battery data storage and a Bluetooth communication module Note The bio potential sensors arrive in the package detached from the band Before your monitoring session 8 of the d...

Page 17: ...lastic with the band QR code 8 Rear closing strap Controller The Controller includes the On Off power button LED indicators and a rechargeable battery The On Off power button is located in the center...

Page 18: ...tery is fully charged Indicator Location LED Color LED Behavior State Functionality Input power connector battery status Orange Steady Power OFF Battery charging Green Steady Power OFF Battery is full...

Page 19: ...rging it before first use to a fully charged battery 3 3 Charging the INVU Sensor Band Battery Warning Remove the INVU Sensor Band from your body before connecting the cable for charging Do NOT charge...

Page 20: ...ote When the LED turns green it is an indication that the INVU Sensor Band is fully charged Note In normal Monitoring Mode INVU Sensor Band does not have or need any cable for normal functionality Not...

Page 21: ...NVU Sensor Band battery is pre charged before shipping However it is recommended recharging to a fully charged battery before first use See Charging the INVU Sensor Band Battery in section 3 3 4 3 Ins...

Page 22: ...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: ...toring session 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 d...

Page 24: ...XT 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 y...

Page 25: ...is performed by scanning the band QR code Press The READY TO SCAN on the app screen Figure 4 3 Scan QR Code screen A message requesting permission for the QR scanner application to access your camera...

Page 26: ...o enable camera focusing on the QR code Verify you have sufficient lighting on the QR code to enable the scan and try avoiding light reflections Verify your camera is clean before scanning The device...

Page 27: ...de is only required for your initial connection 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...

Page 28: ...First Time Using INVU by Nuvo Onboarding Process 22 Nuvo Group Ltd Figure 4 8 Prepare for training See section 6 6 for details on how training is performed Press to initiate training...

Page 29: ...owel Release all 4 front straps before applying the band Release each strap by opening its buckle and pulling the bottom strap part Leave the buckles open when done Attach the eight detachable sensors...

Page 30: ...one during the session setup and the monitoring itself Turn the INVU Sensor Band ON by shortly pressing on the Controller ON OFF power button located on the right side of the INVU Sensor Band Figure 5...

Page 31: ...s as much as possible during monitoring Press PREPARE FOR MONITORING to begin the monitoring session Follow the session preparation instructions to ensure proper use of the device The monitoring sessi...

Page 32: ...Sensor Band Power OFF the band by a long press on the power button 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...

Page 33: ...e bpm The average Maternal Heart Rate is displayed numerically for example 75 beats minute Fetal kicks The kicks felt by the pregnant person which are manually inserted by the pregnant person during t...

Page 34: ...u The main menu is accessed from each main screen Press the main menu icon to open the main menu Figure 6 1 Main menu Pressing any one of the main menu fields either opens a screen for performing an a...

Page 35: ...ermitted A remote monitoring session can be started according to your personalized appointment schedule and according to the clinic s working hours Figure 6 2 Home screen monitoring is enabled Note Re...

Page 36: ...d No scheduled session right now According to your personalized scheduling you have no scheduled session right now Check back during your scheduled session time Figure 6 4 Home screen monitoring is bl...

Page 37: ...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 team Figure 6 6 Home screen monitoring is blocked Blocka...

Page 38: ...Ltd The care plan is no longer active Your care plan is no longer active Contact your care team for more details Figure 6 7 Home screen monitoring is blocked Blockage reason Grey colored background i...

Page 39: ...d to you and your baby It includes standard test recommendations performed monitoring sessions and blood pressure tests The past days are displayed on the bottom white background going up to future da...

Page 40: ...n menu opens the Care Lobby screen This screen presents information related to your health care Care plan Contains information related to your care instructions provided by your caregiver Your care pl...

Page 41: ...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 enable...

Page 42: ...r pressing POWER ON the app connects to the registered sensor band and the Getting Ready screen is shown Pressing START PREPARATION presents the session preparation guidelines see section 6 4 1 After...

Page 43: ...p home screen as described in section 6 5 Note You will need to wait a while between one training session to another It s recommended to take off the band and start the preparation process again This...

Page 44: ...The INVU App Training Session 38 Nuvo Group Ltd Figure 6 12 Help and support Tap to start a training session Tap to chat with support Tap to open the help center...

Page 45: ...after a good band signal has been detected for a few minutes Note No clinical monitoring of you or your baby is done during training Note For a successful training session please try to minimize your...

Page 46: ...y 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 t...

Page 47: ...ood signal If the band s signal is weak the training session is paused and step by step instructions on how to improve the signal are shown Press WALK ME THROUGH IT and follow the step by step instruc...

Page 48: ...continues If the band s signal is improved a SIGNAL IMPROVED message appears Otherwise the training session is paused and new instructions on how to improve the signal are shown Press WALK ME THROUGH...

Page 49: ...Invu by Nuvo User Manual The INVU App NV UMLS 0012 43 Figure 6 18 Signal improved...

Page 50: ...e home screen with the updated number of the training sessions performed After completing all the training sessions pressing done will return the user to the home screen with the option to initiate a...

Page 51: ...automatically connects to the registered sensor band and the session preparation guidelines are presented see section 6 5 1 Pressing START SESSION on the last session preparation guidelines screen wil...

Page 52: ...hone s volume is up as the session preparation screens include voice narration Listening will help you understand the instructions fully Getting ready Prepare the following items before each session i...

Page 53: ...ointment remains on the skin in the sensor area there might be difficulties with detecting the heart rate signals Prepare your INVU Sensor Band Place the INVU Sensor Band on a flat surface and releas...

Page 54: ...band before buckling it Tighten the band by pulling one back strap and then the other Now that the back strap is your size you can remove the band Figure 6 25 Adjust to your size instructions Note Yo...

Page 55: ...ion will help you avoid smearing the gel later on Use your fingers to gently slide the upper strap as high as possible along your belly It should be placed just below your chest Pull the side plastic...

Page 56: ...The INVU App Starting a Monitoring Session 50 Nuvo Group Ltd Figure 6 27 Wear the band instructions...

Page 57: ...p straight or reclining iii Make sure all 4 front straps are still tight Make sure your phone s Wi Fi is turned on While Wi Fi is best cellular data also works if Wi Fi isn t available Figure 6 28 Mon...

Page 58: ...ing at a comfortable relaxed position sitting reclining or lying on your back Minimize your movements as much as possible during monitoring Pay attention to INVU app sounds and notifications during th...

Page 59: ...ss 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 success...

Page 60: ...Group Ltd Figure 6 32 Session setup completed Note In case of a process failure see troubleshooting section 8 3 on page 58 Session elapsed time including the last minute from the session setup Total s...

Page 61: ...ts the average heart rate of your baby This is a simulated sound of the heartbeat Report a kick Use this button to let your care team know when your baby is kicking Report a contraction It s important...

Page 62: ...splayed according to the selected card You pregnant person card or Baby card Note If a poor Bluetooth or internet connection is detected which may cause a potential delay in session a banner will appe...

Page 63: ...the setup Note Moving between the Baby and the Pregnant person You cards is performed by pressing on the tab display Figure 6 36 Baby monitoring card When you feel a kick contraction tap the Kick Cont...

Page 64: ...anually It will cause deviation of your care plan as prescribed by your care team The session ends automatically once it reaches the prescribed duration After session completion press SESSION SUMMARY...

Page 65: ...ion ends or is stopped by pressing SESSION SUMMARY on the Session Completed screen The session summary screen displays the following information The measurements and self reported events during the se...

Page 66: ...RESSURE button on the Session completion screen or on the Blood pressure trends screen to record your readings Figure 6 23 Session completed Figure 6 24 My blood pressure trends For the first two atte...

Page 67: ...diastolic value in the proper place Figure 6 30 Your reading 1 Figure 6 31 Your reading 2 Enter the diastolic value of the first reading as shown in the blood pressure monitor Enter the systolic value...

Page 68: ...ire 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 quic...

Page 69: ...en green and blue Figure 6 45 Update in progress screen Once the update is completed the INVU App shall reconnect to the INVU Sensor Band and you will be able to continue with conducting the monitorin...

Page 70: ...outer side Item Inspection 2 Controller with On Off power button Press the power ON OFF switch on the control unit to see if the power lamps on the control unit light up Check if the battery has been...

Page 71: ...grade power supply and charging cable Check provided power supply for any damage Do not use any other power supply but the one provided with the kit 7 2 Cleaning the INVU Sensor Band Cleaning Before...

Page 72: ...ge and wipe the spray using a dry lint free cloth Spray the cables with alcoholic based spray provided in the package and wipe the spray using a dry lint free cloth Spray the outer side of the band wi...

Page 73: ...dry lint free cloth Ensure full coverage of the alcoholic spray Let the band parts air dry for 10 min If the device does not appear to be clean at the end of this process repeat the process Caution Do...

Page 74: ...Sensor Band on or near hot surfaces Caution INVU Sensor Band does NOT have any user serviceable parts Do not open the Controller Do not replace the battery In case of malfunction contact Nuvo Group c...

Page 75: ...re designed to accommodate the band sensors Place the INVU Sensor Band center section in the carrying case verifying the band sensors are in the package cavities Figure 7 5 Band center section in carr...

Page 76: ...ce Repackaging the INVU Sensor Band 70 Nuvo Group Ltd 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 sect...

Page 77: ...is not an INVU sensor band QR code or is corrupted Make sure that you are scanning the QR code located on the INVU Sensor Band Try to scan the QR code again If the problem persists please contact cust...

Page 78: ...lease contact customer support via the support chat in the app or at support nuvocares com or 1 800 554 9041 USA only Permission denied error Permissions needed by the application were not granted Pre...

Page 79: ...l during the session Your skin is clean and dry before putting on the band Your monitoring position is either seated reclining or lying on your back The upper and lower straps are placed as far as pos...

Page 80: ...data plan Press CLOSE or CONTINUE If not successful consider switching between Wi Fi and cellular data plan Internet connection Wi Fi or Cellular was turned off during the session The system enables...

Page 81: ...ing or answering calls during the session Close the apps and disconnect the devices taking up your Internet bandwidth Consider switching between Wi Fi and mobile data network Press CONTINUE If this me...

Page 82: ...er error occurred during the session Press the CLOSE button Restart the session If the problem persists please contact customer support via the support chat in the app or at support nuvocares com or 1...

Page 83: ...INVU sensor band from the charger Power On the sensor band Follow session preparation instructions and start a new session If the battery level is at least 20 you can start a new session otherwise a...

Page 84: ...ewall such as medical centers or government facilities it is advised to use a cellular data plan Server Error Server error occurred during the operation Check that your internet connection is working...

Page 85: ...Nuvo User Manual Troubleshooting NV UMLS 0012 79 Note If a problem persists please contact Nuvo Group customer support via the support chat in the app or at support nuvocares com or at 1 800 554 9041...

Page 86: ...m persists contact customer support via the support chat in the app or at support nuvocares com or 1 800 554 9041 USA only INVU Sensor Band does not charge Charger or band malfunction Or No electricit...

Page 87: ...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...

Page 88: ...mend checking this guide before installing a new OS version on your phone Mobile Device Screen Size Resolution Operating System Memory and Space Smartphone 4 7 inches and above Min Resolution 720x 128...

Page 89: ...45 C 32 F 113 F 20 C 68 F Relative Humidity range 5 to 90 non condensing humidity Atmospheric pressure From 70kPa to 106kPa Shelf Life Expected service life 2 000 hours Shelf life 24 months The specif...

Page 90: ...ud service Bluetooth 2 4 GHz Wi Fi 2 4 GHz or 5 GHz through supported Mobile Device LTE Mobile Data transmission optional to Wi Fi through supported Mobile Device Bio Potential Sensing Electrode type...

Page 91: ...g Operating time tOP 4 5 Hrs Charging time tCH 2 Hrs Standby time tSTDBY 168 Hrs Standby power consumption Typ 0 008W Type of sensor Bio potential sensors Biopotential Sensor Number of sensors 8 Numbe...

Page 92: ...rom another Input signal range AFEM 0 6 0 6 V PGA Gain 1 V V ADC resolution 24 b ADC data rate 1 000 Ksps Core frequency MCU 80 MHz Flash memory 1024 KB RAM 128 KB Standard Connectivity IEEE 802 15 Cl...

Page 93: ...ng in accordance with FCC rules The device is SAR compliant according to RF Exposure Procedures and Equipment Authorization Policies for Mobile and Portable Devices by the FCC Due to the low power of...

Page 94: ...k of Electrostatic Discharge ESD 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...

Page 95: ...e manufacturing of the INVU Sensor Band are Brass PC Makrolon 2485 acetal copolymer Nylon Spandex PA FPCBA Monomer Cyanoacrylate PTEE White PTEE polyester PU Al6061 PC Lexan 8040 Stainless Steel Synth...

Page 96: ...is intended for use in the electromagnetic environment specified below The customer or the user of INVU by Nuvo system should assure that it is used in such an environment Emissions test Compliance E...

Page 97: ...9 9 745 780 810 800 960 GSM 800 900 TETRA 800 iDEN 820 CDMA 850 LTE Band 5 Pulse modulation b 18 Hz 28 28 870 930 1 720 1700 1990 GSM 1800 CDMA 1900 GSM 1900 DECT LTE Band 1 3 4 25 UMTS Pulse modulat...

Page 98: ...0 kHz Line description Line 1 Line 2 Line description Line 1 Line 2 Conducted immunity to voltage surges IEC 61000 4 5 2014 AMD1 2017 Applied voltage 0 5 1 0 2 0 kV Applied voltage 0 5 1 0 2 0 kV AC p...

Page 99: ...Electromagnetic environment guidance Phase angle 1 0 45 90 135 180 225 270 315 2 0 3 0 4 0 Phase angle 1 0 45 90 135 180 225 270 315 2 0 3 0 4 0 applied to INVU by Nuvo during the charging mode only D...

Page 100: ...ed from the equation applicable to the frequency of the transmitter Recommended separation distance d 0 58 d 1 2 a The ISM industrial scientific and medical bands between 150 kHz and 80 MHz are 6 765...

Page 101: ...t mobile portable communications equipment could cause interference if it is inadvertently brought into patient areas For this reason an additional factor of 10 3 has been incorporated into the formul...

Page 102: ...ed 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...

Page 103: ...sensitivity in some form in the future 3 Improved signal separation High this is a known problem with the current standard of care which can lead to hazardous results Thus resolving this problem has s...

Page 104: ...ale This ability prevents the user from creating unnecessary tests and putting unnecessary liability on the physician While this benefit is important a remote system can still function without it Thus...

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