Invu By Nuvo™ Usage Restrictions; Regulatory Classification; Complying With Standards - Nuvo invu User Manual

Safety
INVU by Nuvo™ Usage Restrictions
2.6 INVU by Nuvo™ Usage Restrictions
INVU Sensor Band™ must be removed prior to:
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Magnetic Resonance Imaging (MRI) scans
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Computer Tomography (CT) scans
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Direct x-rays
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Defibrillator use
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ECG and EMG connection
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Any other potential exposure to a strong electromagnetic field.
2.7

Regulatory Classification

The INVU by Nuvo™ system, including INVU™ App, is classified as Class II (US).
2.8

Complying with Standards

The INVU Sensor Band™ was approved as per IEC 60601-1-2, which contains tests of
immunity to proximity RF fields of different RF wireless communication equipment. The test
was implemented in accordance with clause 8.1 which defined the maximum power of the
wireless equipment and its minimum distance to the INVU Sensor Band™ at which the INVU
Sensor Band™ functionality stays steady. Thus, the minimum distance of 0.3m to some RF
communicating device can be recommended as the separation distance for The INVU Sensor
Band™.
Per IEC-60601-1-2:2007, the INVU Sensor Band™ was evaluated for recommended
separation distances between portable and mobile RF communications equipment.
Note: Disposal of this device should be performed in accordance with local regulations and
WEEE (Waste of Electrical and Electronic Equipment). Alternatively, the user can send the
device for disposal back to the manufacturer or its local distributor.
8 Nuvo Group Ltd.