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The Powerheart ECD defibrillator system is intended to be used by personnel who have been trained in its operation. The Powerheart ECD 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 Powerheart ECD 3-lead and 5-lead ECG monitoring allows for identification or interpretation of cardiac rhythms or dysrhythmias and calculation of heart rate. The Powerheart ECD noninvasive pacing as a therapy is indicated for patients with symptomatic bradycardia or asystole. The Powerheart ECD 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.

The Powerheart® ECD is a defibrillator/monitor/pacemaker intended for use by personnel trained in its operation. The device is lightweight, portable, easy to use and reliable. It incorporates a 320 x 240 transmissive TFT color display for wide viewing angles in all light conditions. The device operates using either an AC power supply or internal rechargeable Li-Ion battery. The device provides continuous ECG monitoring and three types of therapies: defibrillation, cardioversion and external pacing. Defibrillation can be applied manually or semi-automatically. Pacing therapy can be either fixed or demand. The device employs patented RHYTHMx® software which provides ECG rhythm analysis. STAR® Biphasic waveform delivers impedance-compensated energy ranging from 2-270 Joules. Features and options include external paddles, spoons, disposable pads, 3- and 5-lead ECG, pulse oximetry (SpO2), built-in 60 mm thermal printer, internal storage of event history and remote synchronization to bedside monitor.

The Powerheart® AED G3 and the Powerheart® AED G3 Automatic devices are intended to be used by personnel who have been trained in its operation. The user should be qualified by training in basic life support or other physician-authorized emergency medical response. The device is indicated for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing. Post-resuscitation, if the victim is breathing, the AED should be left attached to allow for acquisition and detection of the ECG rhythm. If a shockable ventricular tachyarrhythmia recurs, the device will charge automatically and advise the operator to deliver therapy (G3) or automatically deliver the charge (G3 Automatic). When a patient is a child or infant up to 8 years of age, or up to 55 lbs (25kg), the device should be used with the Model 9730 Pediatric Attenuated Defibrillation Electrodes. The therapy should not be delayed to determine the patient's exact age or weight.

The Powerheart® AED G3 and G3 Automatic devices are portable, battery-operated, automated external defibrillators (AED) indicated for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing. The devices were modified to provide enhanced voice prompts.

The Powerheart® AED G3 Pro, model 9300P, is intended to be used by personnel who have been trained in its operation. The user should be qualified by training in basic life support or other physician-authorized emergency medical response. The device is indicated for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing. Post-resuscitation, if the victim is breathing, the AED should be left attached to allow for acquisition and detection of the ECG rhythm. If a shockable ventricular tachyarrhythmia recurs, the device will charge automatically and advise the operator to deliver therapy. When a patient is a child or infant up to 8 years of age, or up to 55 Ibs (25kg), the Powerheart AED G3 Pro should be used with the Model 9730 Pediatric Attenuated Defibrillation Electrodes. The therapy should not be delayed to determine the patient's exact age or weight. At the discretion of emergency care personnel, the G3Pro with ECG display enabled can also be used with the Model 5111 ECG Patient Cable to display the rhythm of a responsive or breathing patient, regardless of age. The G3Pro and ECG Patient Cable system provides a non-diagnostic display for attended patient monitoring. While connected the G3Pro ECG Patient Cable, the G3Pro evaluates the patient's ECG and disables its shock capability.

The Powerheart® AED G3Pro is a portable, battery-operated, semi-automatic, low power DC defibrillator. The device is designed to diagnose and monitor the patient's cardiac rhythm and deliver the shock energy as required. The Powerheart@ AED G3Pro also has an ECG display and manual override for advanced users. The device in this submission is equivalent to the current Powerheart® ABD and accessories in commercial distribution that was cleared under premarket 510(k) notifications K022929, K011901, K982710 and K031987. The reason for this premarket notification is to introduce the semi-sutomatic

The Powerheart® AED G3A is intended to be used by personnel who have been trained in its operation. The user should be qualified by training in basic life support or other physician-authorized emergency medical response. The device is indicated for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing. Post-resuscitation, if the victim is breathing, the AED should be left attached to allow for acquisition and detection of the ECG rhythm. If a shockable ventricular tachyarrhythmia recurs, the device will charge automatically and advise the operator to deliver therapy. When the patient is a child or infant up to 8 years of age, or up to 55 lbs (25kg), the Powerheart® AED G3A should be used with the Model 9730 Pediatric Attenuated Defibrillation Electrodes. The therapy should not be delayed to determine the patient's exact age or weight.

The Powerheart® AED G3A is a portable, battery-operated, fully-automatic, low power DC defibrillator. The device is designed to diagnose and monitor the patient's cardiac rhythm and deliver the shock energy as required. The Powerheart® AED device in this submission is equivalent to the current Powerheart® AED and accessories in commercial distribution that was cleared under premarket 510(k) notifications K022929, K011901, K 982710 and K031987. The reason for this premarket notification is to introduce a fully -automation version of the device.

The Powerheart AED is intended for use by personnel who have been trained in its operation. The user should be qualified by training in basic life support or other physician-authorized emergency medical response. The device is indicated for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing. Post-resuscitation, if the victim is breathing, the AED should be left attached to allow for acquisition and detection of the ECG rhythm. If a shockable ventricular tachyarrythmia recurs, the device will charge automatically and advise the operator to deliver therapy. When the patient is a child or infant is up to 8 years of age, or up to 55 lbs (25kg), the Powerheart AED should be used with the Model 9730 Pediatric Attenuated Defibrillation Electrodes. The therapy should not be delayed to determine the patient's exact age or weight.

The Powerheart AED is a portable, battery-operated, semi-automatic, low power DC defibrillator. It will diagnose the patient's cardiac rhythm and advise the operator if and when to deliver the shock energy. The Model 9730 Pediatric Attenuated Defibrillation Electrodes are specially designed electrodes for operation with only the Powerheart AED biphasic waveform. The Model 9730 pediatric electrode has been designed to reduce the energy delivered to the patient from a standard biphasic defibrillation waveforms generated by the Powerheart AED to levels applicable for use on children and infants up to 8 yrs of age or weighing less than 55 lbs (25 kg). This is performed though the use of an attenuating circuit that absorbs the excess energy during defibrillation without adversely affecting the electrode's performance during ECG monitoring. The Model 9730 pediatric electrode is designed as a single use device and is intended for use to defibrillate and monitor of children.

be used for defibrillation, synchronized cardioversion, ECG monitoring and external pacing.

The Multifunctional Electrodes consist of a pair of single-use, hydrogel polymeric selfadhesive electrode pads of equal dimension intended to be used for defibrillation, synchronized cardioversion, ECG monitoring and external pacing. The Multifunctional Electrodes are for use with the Powerheart® Cardiac Rhythm Module and the Powerheart® Automatic External Cardiac Defibrillator (AECD). The electrodes are packaged in a pouch to prevent the gel from drying out. The Model 9640 contains an additional small right leg drive (RLD) electrode on the sternum pad. The RLD electrode is used to eliminate the voltage potential between the patient and defibrillator's ground reference. Inside each electrode connector is an electrode ID chip. The ID chip allows the defibrillator to read the electrode specific information contained in the ID chip.

The Powerheart Cardiac Rhythm Module (CRM) is intended to acquire the ECG rhythm for the detection of, and to provide treatment for, ventricular tachyarrhythmias of patients who are at risk of sudden cardiac arrest. The device is intended to be used in medically supervised environments by trained personnel, in which patients are under the direct care of physicians and/or medical persons authorized by the state, province or country regulations in which they practice. The Powerheart CRM can be used in three modes: fully automatic mode, advisory mode or manual mode and includes a pacer which allows an operator to deliver external stimuli for temporary transcutaneous cardiac pacing. The Powerheart has previously undergone clinical testing on adults which support the safety and effectiveness of using the device on patients at risk of sudden cardiac arrest who are at least 8 years of age. The device is not classified as a wearable external defibrillator and is not intended for use in the home environment.

The Powerheart Cardiac Rhythm Module (CRM) is a compact, lightweight, automatic external cardioverter defibrillator. It incorporates essential circuitry and software to provide a detection/analysis/defibrillation/pacing system, in a single device, for monitoring and providing therapy to patients at risk for Sudden Cardiac Arrest.

The Powerheart AECD is intended to acquire the electrocardiograph rhythm for the detection of, and to provide treatment for, ventricular tachyarrhythmias of in-hospital patients who are at risk of Sudden Cardiac Arrest.

The Powerheart monitors a patient's cardiac electrical activity and detects and treats ventricular tachyarrhythmias. The patient is connected to the device by a patient cable which is attached to both a set of ECG electrodes and a set of defibrillation electrodes. The defibrillation electrodes can be positioned on the patient sternum- apex or anterior-posteriorly. The operator can program the device during set up to use either the ECG electrodes or the defibrillator electrodes to sense ECG. The Powerheart uses a combination of rate and, if programmed by the physician, morphology to determine the presence of shockable arrhythmias. When a shockable arrhythmia is detected, the system delivers cardioversion and/or defibrillation energy through defibrillator electrodes to restore normal cardiac rhythm. Should the arrhythmia continue, the Powerheart will deliver additional electrical countershocks after each subsequent evaluation and programmed delay. Depending upon the programmed parameters as prescribed by the physician, the Powerheart may deliver a maximum of nine pulse sequences. In the event that nine pulse sequences have been delivered, the Powerheart will not automatically deliver any further therapy until: 1) a new shockable rhythm is detected after 60 consecutive seconds of non-shockable rhythm is presented, or 2) the device is reset manually. The energy levels for each individual countershock are also programmed into the device per the physician's prescription.

The AECD Arrhythmia Detection Software, when loaded into the Powerheart AECD is intended to acquire the electrocardiograph rhythm for the detection of, and to provide treatment for, ventricular tachyarrhythmias of in-hospital patients who are at risk of Sudden Cardiac Arrest.

The Cardiac Science, Inc., AECD Arrhythmia Detection Software is simply the "arrhythmia detector" software program which is the primary component of the unmodified Powerheart AECD (K970741). This is a computer software program which analyzes the patient's ECG waveform and determines whether the patient exhibits a non-shockable rhythm, based upon the physician programmed parameters for the patient. This software is not a standalone medical software device. The AECD Arrhythmia Detection Software will be marketed as a component intended to enhance the performance of defibrillators and/or patient monitors by adding this functionality to those products.

The Powerheart® Automatic External Cardioverter Defibrillator (AECD)® system is intended to acquire the electrocardiograph rhythm for the detection of, and to provide treatment for, ventricular tacharrhythmias of in-hospital patients who are at risk of Sudden Cardiac Arrest.

The Powerheart Automatic External Cardioverter Defibrillator monitors a patient's cardiac electrical activity and treats ventricular tacharrhythmias. The Powerheart senses the ECG signal using one set of electrodes, and delivers cardioversion and/or defibrillation energy through another set of electrodes. The cardioversion/defibrillation electrodes are positioned on the patient either transchest or anterior-posteriorly . The Powerheart uses a combination of rate and (if programmed by the physician) morphology to determine the presence of shockable arrhythmias. When a shockable arrhythmia is detected, the system selects the appropriate (i.e., as pre-set by the patient's physician) electrical countershock for delivery attempt restoring normal cardiac rhythm. Should the arrhythmia continue, the Powerheart will proceed with subsequent delivery of energy (as pre-set by the patient's physician) after each additional evaluation and charging period. Depending upon the physician programmed parameters, the Powerheart may deliver a maximum of eight pulse sequences. Then, the Powerheart will deliver no further therapy automatically until 60 seconds of consecutive non-shockable rhythm is presented or the device is reset manually.