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Performing standard tests and monitoring the patient
Critical conditions can occur for the patient even during standard tests due to
inadequate parameter settings or interrupted telemetry.
• Ensure sufficient patient care even during tests.
• After the threshold test, check to determine whether the threshold is clinically and
technically justifiable.
• Continuously monitor the ECG and the patient's condition.
• Cancel testing if necessary.
Do not interrupt 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 RF 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 triggered mode
Triggered modes perform pacing regardless of intrinsic cardiac events. To prevent
undersensing due to electromagnetic interference in special cases, a triggered mode
can be displayed.
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 can only be set
and retained with physician supervision.
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.
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.
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