User Manual

Do not grip the lead with surgical instruments.
Do not use excessive force or surgical instruments to insert a stylet into a lead.
Use ventricular transvenous leads with caution in patients with either a mechanical or
bioprosthetic tricuspid valvular prosthesis.
Use the correct suture sleeve (when needed) for each lead, to immobilize the lead and protect
it against damage from ligatures.
Do not kink leads. Kinking leads may cause additional stress on the leads, possibly resulting
in lead fracture.
Do not insert a lead connector pin into the connector block without first visually verifying that
the setscrew is sufficiently retracted. Do not tighten the setscrew unless a lead connector pin
is inserted because it could damage the connector block.
If a pacing lead is abandoned rather than removed, it must be capped to ensure that it is not
a pathway for currents to or from the heart.
If a header port is unused on the generator, the port must be plugged to protect the generator.
PROGRAMMING AND PACEMAKER OPERATION
Rate adaptive pacing should be used with care in patients unable to tolerate increased pacing
rates.
Minute ventilation rate responsive pacing may be inappropriate for patients who can achieve
respiratory cycles shorter than 1.25 seconds (greater than 48 breaths per minute). Higher
respiratory rates attenuate the impedance signal, which diminishes the MV rate response,
i.e., the pacing rate will drop toward the programmed basic rate.
Do not use the as shipped generator values for pacing amplitude and sensitivity without
verifying that they are appropriate for the patient, because this may result in shortened battery
longevity, improper sensing or loss of capture.
Single chamber ventricular pacing should be used with care in patients who may develop
pacemaker syndrome or who may have a need for maximal atrial contribution.
Abdominal implantation: Do not use combined sensor or minute ventilation sensor-driven
pacing when the pacemaker is implanted abdominally. Accurate measurement of minute
ventilation has not been demonstrated for abdominal placements.
Epicardial leads: Do not use epicardial leads for combined sensor minute ventilation sensor-
driven pacing. Epicardial leads have not been demonstrated to measure minute ventilation.
Rate response should not be enabled before implantation because the sensor will sense
noise resulting in inappropriate rates.
For ALIZEA DR model:
Crosstalk results in atrioventricular (AV) pacing with a 95 ms AV delay. This may be avoided
by appropriate choice of sensitivities.
Slow retrograde conduction, especially with conduction time > 469 ms, may induce
pacemaker-mediated tachycardia.
RATE INCREASES
Twiddler’s syndrome, i.e., patient manipulation of the device after implant, may cause pacing
rate to increase temporarily if the pacemaker is programmed to combined sensor or
accelerometer-only sensor mode.
9.6.
9.7.
9. PHYSICIAN GUIDELINES
26 ALIZEA – UA10414A