User's Manual

2 Cardiac Airbag Technical Manual
The Cardiac Airbag and Cardiac Airbag-T have two DF-1
defibrillation / cardioversion and one IS-1 pacing/sensing header
ports. IS-1 refers to the international standard whereby leads
and generators from different manufacturers are assured a basic
fit [Reference ISO 5841-3:1992]. DF-1 refers to the international
standard for defibrillation lead connectors [Reference ISO
11318:1993].
External devices that interact with and test the implantable
devices are also part of the ICD System. These external devices
include the TMS 1000
PLUS
Tachyarrhythmia Monitoring System
and the EPR 1000
PLUS
Programming and Monitoring System.
These programmers are used to interrogate and program the
ICDs. In addition, the programmer software is used to perform
the interrogation and programming of the ICDs during implant
and follow-up testing.
1.2 Indications and Usage
The Cardiac Airbag Implantable Cardioverter Defibrillators
(ICDs) are intended to provide ventricular defibrillation for
automated treatment of life-threatening ventricular arrhythmias.
1.3 Contraindications
Do not use the Cardiac Airbag Implantable Cardioverter
Defibrillators (ICDs) in patients:
• Whose ventricular tachyarrhythmias may have transient
or reversible causes including:
- acute myocardial infarction
- digitalis intoxication
- drowning
- electrocution
- electrolyte imbalance
- sepsis
- hypoxia
• Patients with incessant VT of VF
• Patients with unipolar pacemaker
• Patients whose only disorder is brady arrhythmia or
atrial arrhythmia