Adverse Events - Nuvo INVU User Manual

Safety

Adverse Events

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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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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.
2.4 Adverse Events
There are no known adverse events related to the use of INVU by Nuvo™; however, there
are possible adverse events related to monitoring systems that involve sensor application
on the skin. These include the following:
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Edema
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Erythema
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Irritation
•
Sensitization
6 Nuvo Group Ltd.