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The G5 Automated External Defibrillator (AED) is intended to be used by persons who have been trained in its operation. The user should be trained in basic life support or other physician-authorized emergency medical response. An AED is indicated for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing or not breathing normally. Postresuscitation, if the patient 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 a shock, or for an automatic AED, automatically deliver a shock if needed. When a patient is a child up to 8 years of age, or up to 25kg (55 lbs), the AED should be used with the Pediatric Defibrillation Pads. The therapy should not be delayed to determine the patient's exact age or weight. The optional CPR Device offers CPR performance feedback to aid a trained rescuer by providing compression rate and depth performance feedback through audio prompting. The CPR Device is indicated for use on cardiac arrest patients 8 years of age or older, or who weigh more than 25 kg (55 lbs).

The Powerheart® G5 AED is a portable, battery operated, self-testing defibrillator used to diagnose and treat life threatening ventricular arrhythmias in patients who are unresponsive and not breathing or not breathing normally. This is accomplished by monitoring the patient's ECG and delivering a defibrillation shock if necessary. The AED is intended to be used by a person designated within a community, locale or building who is the first responder to a medical emergency. This typically includes ambulance, police or fire fighting personnel, emergency response team members, security personnel, and lay persons who have been trained in CPR and in the use of the AED. The Powerheart® G5 AED guides the user through a rescue using voice or text prompts. Defibrillation pads are used to monitor and defibrillate patients. Defibrillation pads, meant for patients older than 8 years or heavier than 55 lb, are preconnected to the Powerheart G5 AED and placed in two locations on the patient during a rescue. Pediatric pads are connected to the AED when a pediatric patient is involved and meant for use on those patients 8 years or younger, or 55 lb or lighter. The Powerheart® G5 CPR Device (CPRD), used in conjunction with the G5 AED, is a single use tool that provides CPR performance feedback to aid a CPR trained rescuer in the performance of CPR. The CPRD provides compression rate and depth audio feedback. CPR measurements are recorded for post-event review.

The GS Automated External Defibrillator (AED) is intended to be used by persons who have been trained in its operation. The user should be trained in basic life support or other physician-authorized emergency medical response. An AED is indicated for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing or not breathing normally. Postresuscitation, if the patient 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 a shock, or for an automatic AED, automatically deliver a shock if needed. When a patient is a child up to 8 years of age, or up to 25kg (55 lbs), the AED should be used with the Pediatric Defibrillation Pads. The therapy should not be delayed to determine the patient's exact age or weight.

The Powerheart® G5 AED is a portable, battery operated, self-testing defibrillator used to diagnose and treat life threatening ventricular arrhythmias in patients who are unresponsive and not breathing or not breathing normally. This is accomplished by monitoring the patient's ECG and delivering a defibrillation shock if necessary. The AED is intended to be used by a person designated within a community, locale or building who is the first responder to a medical emergency. This typically includes ambulance, police or fire fighting personnel, emergency response team members, security personnel, and lay persons who have been trained in CPR and in the use of the AED. The Powerheart® G5 AED guides the user through a rescue using voice or text prompts. Defibrillation pads are used to monitor and defibrillate patients. Adult pads, meant for patients older than 8 years or heavier than 55 lb, are preconnected to the Powerheart G5 AED and placed in two locations on the patient during a resoue. Pediatric pads are connected to the AED when a pediatric patient is involved and meant for use on those patients 8 years or younger, or 55 lb or lighter.

The mySense Heart is indicated for use with patients who experience transient symptoms such as syncope, palpitations, shortness of breath or chest pains.

The mySense™ Heart, developed by Cardiac Science Corporation (CSC), is small, lightweight, patch-style cardiac monitor, designed for ambulatory collection of electrocardiographic (ECG) data continuously for up to 24 hours. The device system is composed of 2 main components: - . Recorder - The mySense Heart recorder is about the size of a large band-aid and contains 2 electrodes that are used for sensing and detecting a patient's ECG. The recorder has an adhesive pad so that it can be attached to the patient's skin in the chest region for ECG collection. - Recorder Processing Software (RPS) The RPS is installed on a . computer where the patient's ECG data on the recorder will be downloaded for subsequent analysis by ECG technicians/clinicians.

The Powerheart® AED G3 family of devices 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 ECG rhythm. If a shockable ventricular tachyarrhythmia recurs, the device will change automatically and advise the operator to deliver therapy (G3) or automatically deliver the charge (G3 Automatic). When the 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. Additional information exclusive to the Powerheart® AED G3 Pro, Model 9300P: At the discretion of emergency care personnel, the G3Pro with ECG display enabled can also be used with 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 G3 family of devices (Model numbers 9300A/E, model numbers 9390A/E, and model number 9300P) are portable, battery operated, automatic or semi-automatic, automated external defibrillators (AED). After applying the AED electrodes (pads) to the patient's bare chest, the AED automatically analyzes the patient's electrocardiogram (EGG) and guides the operator through the rescue using a combination of voice prompts, audible alerts, and visible indicators. For the Powerheart® AED G3 Automatic, the AED automatically delivers a shock if needed. For the Powerheart® AED G3 Semi-automatic, the AED uses one button and advises the operator to press the button and deliver a shock if needed. The Powerheart® AED G3 family of devices includes a periodic automatic self-test feature. The focus of this submission is a software modification to enhance the detection capability of the device self-test feature.

The Cardiac Science CareCenter MD is intended to be used by trained operators under the direct supervision of a licensed healthcare practitioner on adult and pediatric populations. The device is designed to acquire, display, process, record, analyze and output 12 lead ECG data during periods of physiological stress, induced through exercise or pharmacological means or during resting ECG testing. In addition, the CareCenter MD provides interfaces for acquiring physiological data from ancillary devices (such as spirometry and blood pressure) and records ECG in real time with and without arrhythmia detection. The system provides automatic interpretation of resting ECG on adult populations. No automatic interpretation of resting ECGs is provided for pediatric populations. Interpretive statements should be overviewed and approved by trained physicians. The CareCenter MD may provide interfaces for the control of external devices such as a treadmill or an ergometer, and for communicating with centralized computer systems via a network. The device is intended to provide non-diagnostic patient data management functions as both a selfcontained, stand-alone application and by interfacing with Electronic Medical Records systems. The device is not intended to be used as a vital signs or long term physiological monitor. The CareCenter MD is not intended to be used as a transport device.

The Cardiac Science CareCenter MD is a medical device system comprised of software and hardware acquisition modules used for acquisition, evaluation and administration of 12-channel electrocardiograph (ECG) from patients both at rest and during exercise (stress testing). The Cardiac Science CareCenter MD software is installed on a customer provided personal computer (PC). CareCenter MD is a diagnostic device capable of ECG monitoring; ST analysis and arrhythmia detection; generation, review, and storage of stress reports; interpretation of resting ECG reports; and treadmill or ergometer control. Approved serial devices such as non-invasive blood pressure measurement are supported by CareCenter MD for stress testing.

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 physicianauthorized emergency medical response. The device is indicated for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing. Postresuscitation, if the victim is breathing, the AED should be left attached to allow for acquisition and detection of 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 the 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 are portable, battery operated, automated external defibrillators (AED). After applying the AED's electrodes (pads) to the patient's bare chest, the AED automatically analyzes the patient's electrocardiogram (ECG) and advises the operator to press the button and deliver a shock if needed. The AED uses one button and guides the operator through the rescue using a combination of voice prompts, audible alerts, and visible indicators. For the Powerheart AED G3 Automatic, the AED automatically delivers a shock if needed. The Cardiac Science G3 AEDs may be used in conjunction with an adaptor cable that allows the use of AAMI DF-80 compliant electrodes other than the Cardiac Science brand. This adaptor cable is provided as an accessory to the Cardiac Science AEDs.

Cardiac Science 9131 Defibrillation Electrodes are single use and intended to be used in conjunction with Cardiac Science automatic external defibrillators (AED) to monitor and deliver defibrillation energy to the patient. Cardiac Science 9133 Defibrillation Electrodes are single use and intended to be used in conjunction with compatible automatic external defibrillators (AED) from Zoll or Physio-Control to monitor and deliver defibrillation energy to the patient, via brand-specific adapters. The brand-specific adapters are available for the AEDs specified in the product labeling. The electrodes are intended for short term use (<8 hours) and must be used before the expiration date listed on the packaging. The AED electrodes are used for emergency treatment of cardiac arrest patients over 8 years of age or greater than 55 pounds. The user assesses the patient's condition and confirms that the patient is unconscious, pulseless and is not breathing prior to applying the electrodes to the skin.

The model 9131 and the 9133 Defibrillation Electrodes consists of a pair (2 each) of hydrogel polymeric self adhesive electrode pads of equal dimension. The outer dimension for each pad is 4.88in (12.4cm) by 4.88in (12.4 cm). Each electrode pad has a conductive hydrogel polymeric area of at least 50cm2 to comply with the AAMI DF-80 (AAMI DF-39) specifications. The total surface area of the two electrodes is greater or equal to 150cm2. The electrodes pads are packaged in such a way that the two conductive hydrogel surfaces are in electrical contact. This feature enables the Cardiac Science AED to run diagnostic checks on the electrodes by checking the inter-electrode impedance when the electrode package is connected to and stored in the device. The Cardiac Science 9133 defibrillation electrodes may be used in conjunction with adaptor cables that allow the electrodes to be used with compliant AEDs other than the Cardiac Science brands. These adaptor cables are provided as accessories to the Cardiac Science defibrillation electrodes.

The device is intended to acquire, process, record, archive, analyze, and output electrocardiographic data during physiologic stress testing. The device may interface with external devices, including a treadmill or ergometer for dynamic exercise evaluation, non-invasive blood pressure equipment, and computer communications equipment. The device is intended for use in a clinical setting by trained personnel under the supervision of a licensed physician. The device is intended for adult populations, typically symptomatic. The device is not intended to be used as a vital signs physiological monitor.

Q-Stress and HeartStride are diagnostic devices capable of ECG monitoring; ST analysis and ventricular ectopic beat detection; generation, review, and storage of stress reports; and treadmill or ergometer control. These devices consist of a patient cable, preamplifier, PC, display, mouse, printer, keyboard, and isolation power supply. Approved serial devices such as non-invasive blood pressure measurement may be supported by these devices. Electrocardiographic data is obtained by the preamplifier and sent to the CPU for processing. The user may generate reports for display or may opt to print results via a printer.

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.

Under the supervision of a qualified physician trained in ECG interpretation, Atria can be used to record the electrical activity of the heart for the purpose of correlating the resultant waveforms with the health of the heart muscle tissue structures. This equipment is not designed to produce a definitive interpretation nor exhaustive evaluation of the patient's heart but rather provide an effective beginning for evaluation of adult and pediatric patients with cardiac abnormalities.

The Atria 3100 and 6100 are 12 lead electrocardiographs designed to record the electrical activity of the heart. They can display, print, electronically send and save ECG recordings. The Atria 6100 features a full alpha numeric keyboard and color display for data entry, waveform review and editing machine settings. The unit provides the ability to store 150 ECGs, print rhythm strips manually or automatically, and provides an optional interpretation. Advanced communications options allow the unit to fax, email and upload results to shared network drives via wired Ethernet, wireless 802.11 and modem. The differences between the Atria 3100 and 6100 are as follows: 1. Screen Size: Atria 3100 = 2 x 40 character display for data entry only (no waveform . viewing) Atria 6100 = 640 x 480 color TFT VGA preview screen for waveform . viewing 2. Storage: . Atria 3100 = 50 records Atria 6100 = 150 records . 3. The Atria 6100 has a slightly different keyboard to accommodate navigation in the User Interface.