Use Instructions

16
other sources of electrical noise in the health-care environments, it is possible that high levels
of such interference due to proximity or strength of the source may result in the disruption of
performance of the Novii system.
Risks and Characterization associated with Electro Magnetic Interferences:
Risk
EMI characterization
High EMI interrupting
the Bluetooth
transmission
between the Novii
POD and Novii
Interface
This will present as a simultaneous gap in the FHR, MHR and UA
data to the user
The Bluetooth connection can be interrupted intermittently or
constantly. The Bluetooth communication interruptions will create
gaps on the tracing of the Maternal/Fetal Monitor attached to the Novii
System. In the event of such interference these gaps will typically
occur simultaneously on the FHR, MHR and Uterine Activity tracing
even if the patient is in close proximity of the Novii Interface.
High EMI present on
the inputs of the
Novii POD
This will present to the user as gaps in FHR data only
On some occasions, the electromagnetic interference will not disrupt
the Bluetooth transmission of all signals simultaneously, but gaps will
occur in the FHR tracing only since the Novii System will stop
detecting the FHR if the noise in the abdominal recording is too high
to detect signals accurately.
Electrostatic
Discharge (ESD)
present on the Novii
System (either POD
or Interface)
ESD present on the Novii System could create artifacts. Specifically,
this artifact will present as transient changes to the FHR trace,
appearing as deflections on the FHR trace of 35 BPM maximum (e.g.
from a reading of 120 BPM down to 85 BPM). These FHR deflections
are very short in duration and would appear to the user as a spike on
the FHR trace.
Once the source of ESD interference has been removed the Novii
System will go on working as normal, there will be no permanent
damage to the system.
If you suspect your Novii System is affected by electromagnetic interference from another
electrical device, it may be necessary to take mitigation measures, such as re-orienting or
relocating the Novii Interface or the device creating the interference. In general, the further away
the Novii System is from the interfering device, the lower the interference will be (please follow
guide lines of Warning G below for minimum distances with other electrical equipment). If the
device creating interference is not in use, it is advised to turn it off. Turning equipment in the
vicinity off and on can help to isolate the offending equipment.
WARNING: A) The Novii system is medical electrical equipment and needs special precautions
regarding EMC: it needs to be installed and put into service according to the EMC
information provided in this section.
WARNING: B) Portable and mobile RF communications equipment can affect medical electrical
equipment.