•
Do not suture directly over lead.
Do not suture directly over the lead body, as this may cause structural
damage. Use the suture sleeve to secure the lead proximal to the venous entry site to prevent lead
movement.
Device Programming
•
Device communication.
Use only the designated PRM and software application to communicate
with this pulse generator.
•
STAT PACE settings.
When a pulse generator is programmed to STAT PACE settings, it will continue to
pace at the high-energy STAT PACE values if it is not reprogrammed. The use of STAT PACE parameters
will likely decrease device longevity.
•
Biventricular pacing therapy.
This device is intended to provide biventricular pacing therapy.
Programming the device to provide RV-only pacing, or programming the RV pace amplitude below the
pacing threshold (resulting in LV-only pacing), is not intended for the treatment of heart failure. The
clinical effects of LV-only or RV-only pacing for the treatment of heart failure have not been established.
•
Pacing and sensing margins.
Consider lead maturation in your choice of Pacing Amplitude, pacing
Pulse Width, and Sensitivity settings.
•
An acute Pacing Threshold greater than 1.5 V or a chronic Pacing Threshold greater than 3 V can
result in loss of capture because thresholds may increase over time.
•
An R-Wave Amplitude less than 5 mV or a P-Wave Amplitude less than 2 mV can result in
undersensing because the sensed amplitude may decrease after implantation.
•
Pacing Lead Impedance should be greater than the programmed Low Impedance Limit (between
200 and 500
Ω
) and less than the programmed High Impedance Limit (between 2000 and 3000
Ω
).
•
Proper programming of the lead con
fi
guration.
If the Lead Con
fi
guration is programmed to Bipolar
when a unipolar lead is implanted, pacing will not occur.
10