User Manual

18 Implantation 
Precautionary Measures while Programming
Precautionary Measures while Programming
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CAUTION
Safety information
The programming of device systems requires special precautions.
Checking the device system • After auto-initialization, perform a follow-up to see if the device system is
functioning properly.
• Perform a pacing threshold test to determine the pacing threshold.
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 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.
• Please carefully take all precautionary measures into account.