Adverse Events; General Warnings And Cautions - Nuvo INVU Quick User Manual

• 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
•
2.5

General Warnings and Cautions

WARNINGS:
• If the INVU Sensor Band™ package, INVU Sensor Band™, or any of its
accessories are damaged or are not intact — do not use the device
and contact Nuvo Group customer support.
• INVU Sensor Band™ contains no user-serviceable components. Do
not try to repair this product or any of its parts. Contact Nuvo Group
customer support.
• NEVER wear the INVU Sensor Band™ while it is being charged!
• NEVER try to replace the rechargeable battery!
• Keep the INVU Sensor Band™ away from the reach of children. Do
not leave the device unattended, or at the sole presence of kids or
pets that might unintentionally harm the device.
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