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As referenced in this secon, the CENELEC standard EN45502‑2‑1:2003 is equivalent to ANSI/AAMI PC69:2007.
The following is applicable to Canada only:
This device may not interfere with staons operang in the 400.150‑406.000 MHz band in the meteorological
aids, meteorological‑satellite, and earth exploraon‑satellite services and must accept any interference
received, including interference that may cause undesired operaon.
This device complies with Industry Canada license‑exempt RSS standard(s). Operaon is subject to the
following two condions: (1) this device may not cause interference, and (2) this device must accept any
interference, including interference that may cause undesired operaon of the device.
Detecon Performance in the Presence of Electromagnec
Interference
When the Sense Conguraon is set to Bipolar, the Atrial Sensivity seng of 0.2 mV or more sensive
sengs may be more suscepble to electromagnec interference (EMI). The devices comply with the
electromagnec compability requirements of CENELEC standard EN45502‑2‑1
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, clause 27.5, at Atrial
Sensivity sengs of 0.3 mV and less sensive sengs.
When the Sense Conguraon is set to Unipolar, the Atrial and Ventricular Sensivity sengs more sensive
than 2.0 mV may be more suscepble to EMI. The devices comply with the electromagnec compability
requirements of CENELEC standard EN45502‑2‑1, clause 27.5, at Atrial and Ventricular Sensivity sengs of
2.0 mV and less sensive sengs. (CENELEC standard EN45502‑2‑1, clause 27.5.1, requires that the
implantable pulse generator be constructed so that commonly encountered electromagnec signals are
unlikely to be confused with sensed beats and change the therapeuc behavior of the implantable pulse
generator.)
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