Limitation Of Use - Nuvo INVU Quick User Manual

Implanted electronic devices (pacemakers, defibrillator, etc.)
•
• During labor or at the delivery room.
• During critical care situations or in laboring patients or those
patients hospitalized for or suspected to have preterm labor.
• During antepartum monitoring (i.e. non-stress testing).
• Pregnant women with known heart issues such as arrhythmia, etc.
• Known allergy to the:
• Fabric of the band (80% Polyamide and 20% Elastane and TPU
[Polyester-based Thermoplastic Polyurethane]).
• Components of the sensors (Polyamide, Elastomer, Silver,
Polyurethane, and Aluminum).
• Plastic components: PA220 (Nylon12).
• 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.
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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.
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