NV-UMLS-0012
May 2022
User Manual
Страница 1: ...NV UMLS 0012 May 2022 User Manual User Manual...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 49: ...Invu by Nuvo User Manual The INVU App NV UMLS 0012 43 Figure 6 18 Signal improved...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 56: ...The INVU App Starting a Monitoring Session 50 Nuvo Group Ltd Figure 6 27 Wear the band instructions...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
