Intended Use
The Sterilizable Internal Defibrillation Paddles are intended for use with LIFEPAK defibrillators to
internally detect ECG rhythm and provide defibrillation or synchronized cardioversion directly to
the surgically exposed heart within a sterile use environment.
Indications
Defibrillation is indicated for the termination of certain potentially fatal arrhythmias, such as
ventricular fibrillation and symptomatic ventricular tachycardia.
Synchronized cardioversion is indicated for the treatment of atrial fibrillation, atrial flutter,
paroxysmal supraventricular tachycardia, supraventricular tachycardia, and in relatively stable
patients, ventricular tachycardia.
Contraindications
Defibrillation is contraindicated in the treatment of Pulseless Electrical Activity (PEA), such as
idioventricular or ventricular escape rhythms, and in the treatment of asystole.
Synchronized cardioversion is contraindicated in the treatment of Pulseless Electrical Activity
(PEA) such as idioventricular or ventricular escape rhythms, asystole, and ventricular fibrillation.
Operator Training
This product should be used only by medical professionals with appropriate training, in a
hospital setting.
Safety Information
The following terms are used in this manual to describe potential hazards:
Danger: Immediate hazards that will result in serious personal injury or death.
Warning: Hazards or unsafe practices that may result in serious personal injury or death.
Caution: Hazards or unsafe practices that may result in minor personal injury, product
damage, or property damage.
Sterilizable Internal Defibrillation Paddles Instructions for Use
English
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