User Manual

IMPLANTATION AND DEVICE PROGRAMMING
Use only a MicroPort programmer to communicate with the device.
Replace the device when the RRT (Recommended Replacement Time*) point (defined by
a battery voltage of 2.63 V if Remote monitoring activated or 2.70 V if Remote monitoring
deactivated) is reached.
Lead System
Do not use a lead system other than those with demonstrated compatibility because
undersensing cardiac activity and failure to deliver necessary therapy may result.
Failure to properly insert the torque screwdriver into the perforation at an angle perpendicular
to the connector receptacle may result in damage to the sealing system and its self-sealing
properties.
*corresponds to ERI (Elective Replacement Indicator) previously used.
LEAD EVALUATION AND LEAD CONNECTION
ALIZEA DR has two IS-1 BI connector ports.
ALIZEA SR has one IS-1 connector port.
IS-1 refers to the international standard whereby leads and generators from different
manufacturers are assured a basic fit (ISO 5841-3:2013).
Do not use any lead with this pulse generator without first verifying IS-1 compatibility,
because use with other leads can damage the connector or result in a leaking or intermittent
connection. ALIZEA pacemakers are not compatible with 3.2 mm low profile leads.
Do not use a unipolar lead with ALIZEA SR if minute ventilation rate response is required
because the device’s minute ventilation rate response function will only operate with a bipolar
lead.
For MRI compatibility with ALIZEA SR, the lead shall be bipolar.
Do not use a unipolar atrial lead with ALIZEA DR / ALIZEA SR if atrial autosensing is required,
because atrial autosensing does not operate with a unipolar lead. For MRI compatibility with
ALIZEA DR, both leads shall be bipolar.
Do not enable Ventricular Auto-threshold when using high polarization leads because the
polarization could prevent the pacemaker from assessing ventricular pacing threshold
accurately.
Consider lead maturation in choice of pacing amplitude and sensitivity, because:
― Acute pacing thresholds > 1 V or 2 mA or chronic pacing thresholds > 3 V or 6 mA can
result in loss of capture because thresholds may increase after implantation;
― R wave amplitude < 5 mV or P wave amplitude < 2 mV can result in undersensing
because sensed amplitude may decrease after implantation.
If a unipolar lead is used, program the lead configuration to unipolar prior to implantation.
If the lead configuration is programmed to bipolar with a unipolar lead, pacing will not be
provided.
Do not tie a ligature directly to the lead body, tie it too tightly, or otherwise create excessive
strain at the insertion site as this may damage the lead. Use the lead stabilizer to secure the
lead lateral to the venous entry site.
Do not immerse the leads in mineral oil, silicone oil, or any other liquid.
9.4.
9.5.
9. PHYSICIAN GUIDELINES
ALIZEA – UA10414A 25