Nuvo INVU User Manual page 94

Specifications
System Specifications
High electromagnetic disturbance could
interrupt the Bluetooth communication
channel between INVU Sensor Band™
and Mobile device running INVU Pro or
INVU app.
High electromagnetic disturbance close
to the sensory band.
Risk of Electrostatic Discharge (ESD).
Electromagnetic Compatibility and Essential Performance
INVU Sensor Band™ meets the electromagnetic compatibility requirements as per IEC
60601-1-2:2014 Medical electrical equipment-Part 1-2: General requirements for basic
safety and essential Performance-Collateral—Standard: Electromagnetic disturbances—
Requirements and tests.
INVU Sensor Band™ is a data acquisition device providing sensory data to the Nuvo Cloud
system. The data provided by the Nuvo cloud is MHR, FHR and UA.
The device range for MHR is 50 to 210 bpm, and for FHR it is 50 to 250 bpm. For both
parameters, the expected error is less than 10%.
For UA the expected error cannot exceed ±20% of the full scale for more than 30 seconds.
88
Risk Effect
Disconnection in the Bluetooth channel can
be generated as a result of RF interference.
In these cases, the session should be
reinitiated. No permanent damage is
expected due to RF Bluetooth interference.
As a result of a high-level of electromagnetic
disturbance, a temporary degradation could
be observed on the device. Identifying and
taking distance from the possible source of
electromagnetic disturbance should help to
return to normal functionality.
As a result of this degradation, FHR
detection could be lost.
No permanent damage is expected due to
EMI to the INVU Sensor Band™.
ESD events can occur during the
manipulation of the INVU Sensor Band™.
During Monitoring Mode, an ESD event can
cause the device to turn off, without
permanent damage. The device will return
to normal functionality by restarting the
device and restarting the session It is
recommended to touch a large metal object
before touching the INVU device.
Nuvo Group Ltd.