User Manual Part 1

1-16
INFORMATION FOR USE
PRECAUTIONS
• Radio frequency ablation. Exercise caution when performing radio
frequency ablation procedures in device patients. If the pulse generator
Tachy Mode is programmed to Monitor + Therapy during the procedure,
the device may inappropriately declare a tachycardia episode and deliver
therapy. Pacing therapy may also be inhibited unless the device is
programmed to Electrocautery mode. RF ablation may cause changes in
pacing thresholds; evaluate the patient’s thresholds appropriately.
Minimize risks by following these steps:
• Program the Tachy Mode(s) to Electrocautery Protection to avoid
inadvertent tachycardia detection (sensing) or therapy.
• Monitor the patient and have external defibrillation equipment and
knowledgeable medical personnel available.
• Avoid direct contact between the ablation catheter and the implanted
lead and pulse generator.
• Keep the current path (electrode tip to ground) as far away from the
pulse generator and leads as possible.
• Consider the use of external pacing support for pacemaker-dependent
patients (i.e., using internal or external pacing methods).
• Monitor pre- and post-measurements for sensing and pacing thresholds
and impedances to determine the integrity of the lead-patient function.
Remember to reactivate the pulse generator after turning off the radio
frequency ablation equipment.
• Electrical int erfere n ce. Electrical interference or “noise” from devices
such as electrocautery and monitoring equipment may interfere with
establishing or maintaining telemetry for interrogating or programming the
device. In the presence of such interference, move the programmer away
from electrical devices, and ensure that the wand cord and cables are not
crossing one another. If telemetry is cancelled as a result of interference,
the device should be re-interrogated prior to evaluating information from
pulse generator memory.
- DRAFT -