Limitation Of Use; Adverse Events - Nuvo invu User Manual

Safety

Limitation of Use

•
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.
Note:
A full list of INVU Sensor Band™ material components are listed in section 9.3.7.
2.3 Limitation of Use
•
INVU By Nuvo™ 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 critical care situations or in laboring patients or those
patients hospitalized for or suspected to have preterm labor.
•
INVU by Nuvo™ is not to be used for antepartum monitoring (i.e., non-stress testing).
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:
•
Edema
•
Erythema
•
Irritation
•
Sensitization
6 Nuvo Group Ltd.