When using the Efficia DFM100, electromagnetic compatibility with surrounding devices should be
A medical device can either generate or receive electromagnetic disturbances. Testing for
electromagnetic compatibility EMC with the appropriate accessories has been performed according
to national and international standard for EMC for medical devices.
The EMC standards describe tests for both emitted and received disturbances. Emission tests deal
with electromagnetic disturbances generated by the device being tested.
WARNINGS: Electromagnetic interference coming from other devices may degrade or obstruct the performance of
the Efficia DFM100. The interference may come from signals radiated through the air or it may also
come from signals conducted through wired connections such as power cord, patient connections or
device to device connections such as ECG analog output. Electromagnetic compatibility with
surrounding devices should be assessed prior to using the Efficia DFM100.
When connected to a patient, symptoms of interference may include degraded performance of ECG
signals from pads/paddles or ECG leadsets, unexpected technical alarms, or critical failure status on
the RFU Indicator. Electromagnetic compatibility testing should include both radiated and
conducted immunity. Testing in the presence of potentially interfering surrounding devices should
assess typical Efficia DFM100 usage scenarios including powering on, monitoring and delivering
Fixed, portable, and mobile radio frequency communications equipment could affect the
performance of medical equipment. See
distance between RF communications equipment and the Efficia DFM100.
Reducing Electromagnetic Interference
The Efficia DFM100 and associated accessories may be susceptible to interference from other RF
energy sources and continuous, repetitive, power line bursts. Examples of other sources of RF
interference are medical devices, cellular products, information technology equipment and
radio/television transmission. Should interference be encountered, as demonstrated by error
conditions, artifact on the ECG or dramatic variations in parameter measurement values, attempt to
locate the source. Assess:
Is the interference intermittent or constant?
Does the interference occur only in certain locations?
Does the interference occur only when in close proximity to certain medical devices?
Does the interference occur only when certain medical devices are turned on?
Does the interference occur only when certain medical devices are connected to the same patient
as the Efficia DFM100?
Do parameter measurement values change dramatically when the AC line cord is unplugged?
Once the source is located, attempt to attenuate the EMC coupling path by distancing the
monitor/defibrillator from the source as much as possible or by changing the location or routing of
wired connections. If assistance is needed, call your local service representative.
for the minimum recommended separation