BIOTRONIK Evity 6 Manuel Technique page 13

Do not interrupt wandless telemetry during a treatment
Disconnecting the SafeSync Module from the programmer can result in interference
with or termination of the SafeSync wandless telemetry.
• Do not disconnect the SafeSync Module from the programmer.
• Do not take the Operation Module off the ICS 3000.
Cancelling telemetry
Programmer interference or interrupted telemetry during performance of temporary
programs (follow-up tests) can result in inadequate pacing of the patient. This is the
case if the programmer can no longer be operated due to a program error or
a defective touch screen and therefore the temporary program cannot be terminated.
Under these circumstances, it is helpful to cancel telemetry, in which case the device
automatically switches to the permanent program.
• In the case of telemetry with PGH: lift the programming head by at least 30 cm.
• In the case of wandless telemetry: switch off and reposition the programmer.
• Turn off possible sources of interference.
Avoiding critical parameter settings
No modes and parameter combinations that pose a risk to the patient should be set.
• Prior to setting rate adaptation, determine the patient's capacity for strain.
• Check compatibility and effectiveness of parameter combinations after making
settings.
Manually setting lead polarity
Due to the risk of an entrance/exit block, bipolar lead polarity (sensing/pacing) should
only be set if bipolar leads are implanted.
Setting sensing
Manually set parameters can be unsafe. For example, unsuitable far-field protection
may impede sensing of intrinsic pulses.
• Use automatic sensitivity control.
Setting the sensitivity
A value set to < 2.5 mV/unipolar for device sensitivity may result in noise caused by
electromagnetic fields.
• Therefore, it is recommended that a value of ≥ 2.5 mV/unipolar be set according to
paragraph 28.22.1 of the EN 45502-2-1 standard. Setting sensitivity values
< 2.5 mV/unipolar requires explicit clinical need. Values like this must only be set
and retained with physician supervision.
Note: Sensitivity in the atrium meets the requirements for electromagnetic compati-
bility as long as it is ≥ 0.3 mV/bipolar. Measures must be taken to assure interference-
free therapy if more sensitive values < 0.3 mV/bipolar are set.
Preventing device-induced complications
BIOTRONIK devices are equipped with several functions to prevent device-induced
complications to the greatest extent possible:
• Measure the retrograde conduction time.
• If the function is not yet automatically set: activate PMT protection.
• Set the VA criterion: The aim is to set a VA criterion that is longer than the longest
measured retrograde conduction time.
Preventing conduction of atrial tachycardia
BIOTRONIK devices are equipped with several functions to prevent conduction of atrial
tachycardia to the ventricle(s):
• Set Mode Switching for indicated patients.
• Set the upper rate and the refractory periods to prevent abrupt ventricular rate
switching.
• Prefer Wenckebach response and avoid 2:1 behavior.
• Set all parameters so as to prevent constant changing between atrial and ventric-
ular-controlled modes.
Phrenic nerve stimulation that cannot be terminated
With LV pacing, chronic phrenic nerve stimulation can in rare cases not be terminated
by reprogramming the available left ventricular pacing configurations or by other
measures.
• Possibly set a right ventricular mode both in the permanent program and for
Mode Switching.
Avoiding risks in the case of exclusive left ventricular pacing
Lead dislodgement in the case of exclusive left ventricular pacing could pose the
following risks: loss of ventricular pacing as well as induction of atrial arrhythmia.
• Consider sensing and pacing parameters with reference to loss of therapy.
• Exclusive left ventricular pacing is not recommended for patients who depend on
the device.
12