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Candidates for Remote Monitoring / Who is an ideal candidate for at-home monitoring?

Who is an ideal candidate for at-home monitoring?

The ideal candidate for at-home monitoring is a pregnant patient carrying a singleton gestation who requires frequent clinically indicated nonstress testing, is interested in remote care, and has access to both Wi-Fi and a smartphone (iOS or Android). While patients of all backgrounds may benefit from remote monitoring, it can be especially beneficial for underserved populations in any setting (both urban and rural) experiencing barriers to care access. At this time, the application and instructions for INVU is only available in English, although we anticipate adding other languages in the future.

 

Additionally, please see the below indications, contraindications, and limitations for use…

 

Indication For Use:

INVU by Nuvo™ is a maternal-fetal monitor that non-invasively measures and displays fetal heart rate (FHR), maternal heart rate (MHR) and Uterine Activity (UA).

 

The INVU Sensor Band acquires the fetal heart electrocardiogram and maternal heart electrocardiogram signals from abdominal surface electrodes and the fetal phonocardiogram and the maternal phonocardiogram signals from surface acoustic sensors. 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.

 

The INVU by Nuvo™ maternal-fetal monitor is intended for use by healthcare professionals in health care facilities and by the patient in the patient’s home, on the order of a physician.

 

The INVU by Nuvo™ is indicated for antepartum fetal surveillance (i.e. non-stress testing).

 

This system does not prevent the onset of preterm labor nor will it prevent the occurrence of preterm birth.

 

Contraindications:

INVU by Nuvo™ should not be used by pregnant people who meet one (or more) of the criteria below:

  • Multiple gestation pregnancy (more than one fetus).

  • BMI ≥45 or ≤15 prior to pregnancy.

  • Fetal anomaly.

  • Uncontrolled hypertension.

  • Medical skin condition (for example, Edema, Erythema or any open wound, irritation and/or any skin infection).

  • Implanted electronic devices (pacemakers, defibrillator, etc.)

  • During labor or at the delivery room.

  • During critical care situations

  • Pregnant people with known heart issues such as arrhythmia, etc.

  • Known allergy to the INVU Sensor Band™ materials.

  • It is advised that the user will take all precautions while experiencing any changes in the device’s performance, that are different than the performance described in this manual. In any such event, the user must not use the device and contact Nuvo Group customer support.

Limitation of Use:

  • INVU Sensor Band™ is a prescription-based device.

  • 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.

  • 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 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.

 

LEGAL DISCLAIMER

No information contained within this FAQ document should be relied upon as professional medical advice, nor shall any information be construed as the practice of medicine or providing medical /advice services by Nuvo. Nuvo does not provide medical advice, diagnosis or treatment, but provisions INVU as a remote patient monitoring device. The information provided in this FAQ document is intended solely as general educational materials even if the information is presented by a licensed medical professional, is not intended to be used for any diagnostic purposes, and is not a substitute for professional medical advice. Readers of this FAQ document should always seek the advice of a physician or other qualified healthcare provider who is familiar with their state of health concerning questions regarding a medical condition, and before starting, stopping or modifying any treatment or medication. Never delay obtaining medical advice or disregard medical advice because of something you have or have not read within this FAQ document. Nuvo makes no warranties or representations as to the accuracy of the information provided within this FAQ document and assumes no responsibility for any consequences relating directly or indirectly to any action or inaction that is taken based upon such information. Readers assume the entire risk of loss in relying upon the information contained within this FAQ document, and should contact their physicians immediately if their health conditions change, and if a Reader requires urgent care, should contact their local emergency services immediately. Neither Nuvo nor its content providers assume any liability or responsibility for damage or injury to you arising from any use of the information, ideas or instructions contained within this FAQ document.

 

USE OF NUVO  Intl GROUP LTD.’S (“NUVO”) INVU PROPRIETARY REMOTE PATIENT MONITORING SOLUTION (“INVU”) IS AT THE USER’S SOLE RISK, AND EACH USER ASSUMES FULL RESPONSIBILITY FOR ALL RISK ASSOCIATED THEREWITH. TO THE FULLEST EXTENT PERMISSIBLE UNDER APPLICABLE LAW, NUVO AND ITS DIRECTORS, OFFICERS, EMPLOYEES AND REPRESENTATIVES (COLLECTIVELY, “AFFILIATES”) HEREBY DISCLAIM ALL REPRESENTATIONS AND WARRANTIES, EXPRESS OR IMPLIED, STATUTORY OR OTHERWISE, INCLUDING BUT NOT LIMITED TO WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NON-INFRINGEMENT, ACCURACY AND/OR SECURITY. WITHOUT LIMITING THE FOREGOING, NUVO AND ITS AFFILIATES MAKE NO WARRANTY AS TO THE RELIABILITY, ACCURACY, REGULATORY COMPLIANCE, TIMELINESS, USEFULNESS, ADEQUACY, COMPLETENESS OR SUITABILITY OF INVU.

 

In addition to the foregoing, Nuvo makes no warranty that INVU will meet a Reader’s or her physician’s requirements, or that the functionality of INVU will be uninterrupted, timely, 100% secure, or error free, or that defects, if any, will be corrected, including loss of data and service interruptions. Nuvo is not responsible for transmission errors or corruption or compromise of data carried over local or interchange telecommunication carriers, although Nuvo will take commercially reasonable precautions to protect against failure of INVU to properly function. Readers acknowledge and agree that data may be lost or corrupted in connection with use of INVU, and while Nuvo may perform regular back-ups of all data stored, it shall have no liability in the event data is lost or destroyed.

 

BY UTILIZING THIS FAQ DOCUMENT, BY PARTICIPATING IN ANY CLINICAL STUDY RELATED TO INVU, AND BY USING INVU, THE READER HEREOF FULLY, VOLUNTARILY AND IRREVOCABLY AGREES TO THE TERMS AND CONDITIONS SET FORTH IN THIS LEGAL DISCLAIMER.