Nuvo invu User Manual page 75

High EMI could interrupt the Bluetooth
communication channel between INVU
Sensor Band™ and Mobile device
running INVU Pro or INVU app.
High EMI 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 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 to the Nuvo cloud is MHR and FHR.
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%.
NV-UMLS-0001
Risk
Invu by Nuvo™User Manual
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 EMI interference, a
temporary degradation could be observed
on the device. Identifying and taking
distance from the possible source of EMI
interference 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 interference 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.
Specifications
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