BIOTRONIK Reocor D Manual Tecnico página 11

8
Interference •
resistance
•
— The set energy should not be higher than necessary
for defibrillation.
— The distance between the leads of the cardiac defi-
brillator and the leads of Reocor D should be at least
10 cm.
— After a defibrillation, Reocor D must be switched off
and then on again so that the device can perform a
complete self-test.
Additionally, after defibrillation the pacemaker function
and pacing threshold must be checked and monitored for
a sufficient period of time.
Reocor D is protected against interference due to elec-
tromagnetic radiation, electrostatic discharge and
against transferred interference. The radiation emitted by
Reocor D has also been minimized. Thus, the device
meets the requirements of IEC 60601-1-2. However, it
still is possible that strong electromagnetic fields which
can occur (e.g., in the direct vicinity of electric motors,
transformers, power lines, and other electric devices)
may impair the function of Reocor D.
Electromagnetic interference can lead to the following
errors:
— Unexpected reset (self-test is executed).
— Cardiac events are sensed but do not appear on the
ECG monitor.
— Reocor D exhibits unexpected behavior.
Measures to restore proper function of Reocor D:
— Check the connection between device and temporary
pacing leads and adjust, if necessary.
— Correctly adjust the sensitivity of the Reocor D: Often,
the sensitivity safety margin is half the average
intrinsic signal amplitude.
— Turn off all electric devices in the vicinity of Reocor D
if they can cause electromagnetic interference and
their operation is not absolutely necessary.
— Move the interference source to a location where the
interference cannot have an affect on the Reocor D.
— If safe to do: Switch Reocor D off and then on again to
reset the pacemaker to interference-free operation.
— If the technical failure persists, please contact
BIOTRONIK.
If the atrial sensitivity is set to a value less than 1 mV,
interference from electromagnetic fields could result.
Thus, if possible sensitivity values higher than 1 mV
should be programmed. Programming sensitivity values
to less than 1 mV requires explicit medical necessity.
Values like this can only be set and retained with physi-
cian supervision.