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Abbott Endurity Core - Page 46

Abbott Endurity Core
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5
As referenced in this secon, the CENELEC standard EN4550221:2003 is equivalent to ANSI/AAMI PC69:2007.
The following is applicable to Canada only:
This device may not interfere with staons operang in the 400.150406.000 MHz band in the meteorological
aids, meteorologicalsatellite, and earth exploraonsatellite services and must accept any interference
received, including interference that may cause undesired operaon.
This device complies with Industry Canada licenseexempt RSS standard(s). Operaon is subject to the
following two condions: (1) this device may not cause interference, and (2) this device must accept any
interference, including interference that may cause undesired operaon of the device.
Detecon Performance in the Presence of Electromagnec
Interference
When the Sense Conguraon is set to Bipolar, the Atrial Sensivity seng of 0.2 mV or more sensive
sengs may be more suscepble to electromagnec interference (EMI). The devices comply with the
electromagnec compability requirements of CENELEC standard EN4550221
5
, clause 27.5, at Atrial
Sensivity sengs of 0.3 mV and less sensive sengs.
When the Sense Conguraon is set to Unipolar, the Atrial and Ventricular Sensivity sengs more sensive
than 2.0 mV may be more suscepble to EMI. The devices comply with the electromagnec compability
requirements of CENELEC standard EN4550221, clause 27.5, at Atrial and Ventricular Sensivity sengs of
2.0 mV and less sensive sengs. (CENELEC standard EN4550221, clause 27.5.1, requires that the
implantable pulse generator be constructed so that commonly encountered electromagnec signals are
unlikely to be confused with sensed beats and change the therapeuc behavior of the implantable pulse
generator.)
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