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INDICATIONS FOR USE/INTENDED USE
The Responder 2000 defibrillator system is intended to be used by personnel who have been trained in its operation.
The Responder 2000 is indicated for the termination of certain fatal arrhythmias, such as ventricular fibrillation and
symptomatic ventricular tachycardia. Delivery of energy in the synchronized mode is a method for treating atrial fibrillation,
atrial flutter, paroxysmal supraventricular tachycardia, and in relatively stable patients, ventricular tachycardia.
The semi-automatic advisory mode is for use in cardiac arrest in patients of at least 8 years of age. The patient must be
unconscious, pulseless, and not breathing spontaneously before using the defibrillator to analyze the patient's ECG
rhythm.
The Responder 2000 3-lead and 5-lead ECG monitoring allows for identification or interpretation of cardiac rhythms or
dysrhythmias and calculation of heart rate.
The Responder 2000 noninvasive pacing as a therapy is indicated for patients with symptomatic bradycardia or asystole.
The Responder 2000 pulse oximetry is intended for the continuous external monitoring of arterial oxygen saturation and
pulse rate and is indicated for use in any patient who is at risk of developing hypoxemia.
CONTRAINDICATIONS FOR USE
CONTRAINDICATIONS FOR MANUAL DEFIBRILLATION THERAPY
Asynchronous defibrillation therapy is contraindicated in patients that exhibit one or any combination of the following:
•
Responsive
•
Spontaneous breathing
•
Palpable pulse
CONTRAINDICATIONS FOR SEMI-AUTOMATIC THERAPY
The semi-automatic shock mode is not be used on patients that exhibit one of any combinations of the following:
•
Responsive
•
Spontaneous breathing
•
Palpable pulse
•
Less than 8 years of age or 55 lbs. (25kg). Therapy should not be delayed to determine patient's exact age or
weight.
CONTRAINDICATIONS FOR NONINVASIVE PACING THERAPY
Noninvasive pacing is contraindicated in the treatment of ventricular fibrillation. Noninvasive pacing in the presence of
severe hypothermia may be contraindicated.
2026116-001 Revision B
Responder™ 2000
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