User Manual Part 1

INFORMATION FOR USE
WARNINGS
1-7
WARNINGS
General
• Labeling knowledge. Read this manual thoroughly before implanting the
pulse generator to avoid damage to the system. Such damage can result in
patient injury or death.
• Avoid shock during handling. Program the pulse generator Tachy
Mode(s) to Off during implant, explant, or postmortem procedures to avoid
inadvertent high voltage shocks.
• Backup defibrillation prot ection. Always have sterile external and
internal defibrillation protection ava ilab le during implant. If not terminated in
a timely fashion, a n induced ventricular tachyarrhythmia can result in the
patient’s death.
• Resuscitatio n availab ility. Ensure that an external defibrillator and
medical personnel skille d in CPR are pres en t during post-implant device
testing should the patient require external rescue.
• Protected environ m e n ts. Advise patients to seek medical guidance
before entering environment s that could adversely affect the operation
of the active implantable medical device, including areas protected by a
warning notice that prevents entry by patients who have a pulse generator.
• Magnetic Resonance Imaging (MRI) exposure. Do not expose a patient
to MR device scanning. Strong magnetic fields may damage the device
and cause injury to the patient.
•Diathermy.Do not subject a patient with an implanted pulse generator
to diathermy since diathermy may cause fibrillation, burning o f the
myocardium, and irreversible damage to the pulse generator because of
induced currents.
Programming and Device Operations
• Atrial tracking modes. Do not use atrial tracking modes in patients with
chronic refractory atrial tachyarrhythmias. Tracking of atrial arrhythmias
could result in VT or VF.
- DRAFT -