BIOTRONIK Cardiac Airbag, Technical Manual, Page: 9 / 92

Cardiac Airbag Technical Manual 3
1.4 Warnings and Precautions
ATP (Anti-Tachycardia Pacing) – The Cardiac Airbag ICD
does not provide ATP therapy. Do not implant this ICD in
patients with documented ventricular tachycardias unless high
energy defibrillation is desired for treatment of the ventricular
arrhythmia.
MRI (Magnetic Resonance Imaging) - Do not expose a patient
dvertent arrhythmia
CD lead
ation Availability - Do not perform induction testing
program the VT/VF Detection and
in
1.4.1 Sterilization, Storage, and Handling
device’s
e-sterilize and re-implant explanted
to MRI device scanning. Strong magnetic fields may damage
the device and cause injury to the patient.
Electrical Isolation - To prevent ina
induction, electrically isolate the patient during the implant
procedure from potentially hazardous leakage currents.
Lead Systems - The use of another manufacturer’s I
system may cause potential adverse consequences such as
under sensing of cardiac activity and failure to deliver necessary
therapy.
Resuscit
unless an alternate source of patient defibrillation such as an
external defibrillator is readily available. In order to implant the
ICD system, it is necessary to induce and convert the patient’s
ventricular tachyarrhythmias.
Unwanted Shocks – Always
Therapy status to DISABLED prior to handling the device to
prevent the delivery of serious shocks to the patient or the
person handling the device during the implant procedure.
Rate-Adaptive Pacing – Use rate-adaptive pacing with care
patients unable to tolerate increased pacing rates.
Device Packaging - Do not use the device if the
packaging is wet, punctured, opened or damaged because the
integrity of the sterile packaging may be compromised. Return
the device to BIOTRONIK.
Re-sterilization - Do not r
devices.