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The Ludlow Gradient Edge Adult & Pediatric Multifunctional Electrode is intended for use in defibrillation procedures, cardioversion, pacing, and ECG monitoring. The Ludlow Gradient Edge Adult Multifunctional Electrode is for use on adults (an adult is defined as a patient weighing over 10 Kg). The Ludlow Gradient Edge Adult Multifunctional Electrode is not intended for use on children or infants. The device is non-sterile and single-use only. The Ludlow Gradient Edge Pediatric Multifunctional Electrode is for use on pediatrics (a pediatric is defined as a patient weighing less than 10 Kg). The device is non-sterile and single-use only.

Ludlow Gradient Edge Adult & Pediatric Multifunctional Electrodes

The Katecho external electrodes are indicated for use in external pacing, defibrillation, cardioversion and monitoring applications as a non-sterile, disposable device for single patient use only. The KDP-85 Electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the patient's skin. The electrode is intended for use on adult patients. When a patient requires defibrillation, cardioversion or external pacing, these electrodes will be applied to the patient and connected to the instrument. This device is intended for use on defibrillators whose output is classified as low power (360 joule maximum). The Katecho KDP-85 Defib/Pace Electrodes are designed for, and to be used, with Agilent Technologies defibrillation devices.

Katecho KDP-85 Adult Defib/Pace Multifunction Electrode. The Katecho external electrodes are indicated for use in external pacing, defibrillation, cardioversion and monitoring applications as a non-sterile, disposable device for single patient use only. The KDP-85 Electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the patient's skin.

TZ Medical adult disposable electrodes are used by trained professionals in hospitals, doctors offices and Emergency medical Services for adult low-energy defibrillation, transcutaneous pacing, cardioversion and monitoring.

PadTac Adult Defibrillate/Cardiovert/Pace Pad Fac Addit Dollahilator - TZ Medical Inc.

PadTac Pediatric disposable electrodes are used by trained professionals in hospitals, doctors offices and Emergency Medical Services for pediatric low-energy defibrillation, cardioversion, pacing and monitoring.

PadTac Pediatric Defibrillate/Cardiovert/Pace/Monitoring Electrodes

The PIC is intended primarily for use by trained emergency responders, trained in advanced life support, cardiac care techniques, interpretation of ECG waveforms, and the use of the PIC. The usage may be in an ambulance or at the scene of an emergency. The PIC is also intended for use by (or on the order of) physicians at the scene of an emergency or in a hospital emergency room, intensive care unit, cardiac care unit, or other similar areas of a hospital. It is also intended to be used during the transport of patients between any of the locations mentioned above. The patient population will consist of adults and children (described below), and will consist of patients both with and without heart dysfunction. The PIC will be used primarily on patients experiencing symptoms of cardiac arrest or in a post trauma situation. It may also be used whenever it is required to monitor any of those functions that are included (as options) in the device. Indications for each of the specific functions are discussed below: DEFIBRILLATOR FUNCTION: The defibrillator function of the PIC is used to treat: ventricular fibrillation and pulseless ventricular tachycardia. Patients may range from neo-natal to adult. DEFIBRILLATOR (INTERNAL PADDLE) FUNCTION: With internal paddles, the defibrillator function of the PIC is used for the termination of ventricular fibrillation during cardiac surgery, with the paddles applied directly to the heart. Patients may range from neo-natal to adult. ECG MONITOR FUNCTION: The ECG monitor function of the PIC is used to monitor and/or record ECG waveform and heart rate, and to alarm when heart rate is above or below limits set by the operator. The PIC also provides output signals for the purpose of sending ECG waveforms to a remote monitor via direct connection, telephone, or radio transmission. Patients may range from neo-natal to adult. EXTERNAL TRANSCUTANEOUS PACEMAKER FUNCTION: The external transcutaneous pacing function of the PIC is used for the emergency treatment of hemodynamically compromising bradycardia, bradycardia with escape rhythms that are unresponsive to pharmacologic therapy, refractory tachycardia (supraventricular or ventricular), and bradyasystolic cardiac arrest. Patients may range from pediatric to adult. NON-INVASIVE BLOOD PRESSURE FUNCTION: The non-invasive blood pressure function of the PIC is used to make non-invasive measurements of arterial pressure and heart rate, and to alarm if either parameter is outside of the limits set by the user. Measurements are made using an inflatable cuff on the patient's arm or (occasionally) leg. Patients may range from pediatric to adult. TEMPERATURE MONITOR FUNCTION: The temperature monitor function of the PIC is used to make continuous measurements of rectal, esophageal, or surface temperature, and to alarm if the temperature is outside of the limits set by the user. It is used on patients ranging from neo-natal to adult. PULSE OXIMETER FUNCTION: The pulse oximeter function of the PIC is used to monitor pulse rate and oxygen saturation of arteriolar hemoglobin, and to alarm if either parameter is outside of the limits set by the user. It is used on patients ranging from neo-natal to adult. Measurements are made non-invasively at remote sites such as a finger, toe, ear lobe, bridge of nose, etc. It is used on patients ranging from neo-natal to adult. RESPIRATION RATE MONITOR FUNCTION: The respiration rate monitor function of the PIC is used to continuously monitor respiration rate and to alarm if the rate falls outside of the range set by the operator. The patients range from neo-natal to adult. Because the measurement method actually measures respiratory effort, apnea episodes with continued respiratory effort (such as obstructive apnea) may not be detected. It is not intended to be used as an apnea monitor. It is used on patients ranging from neo-natal to adult.

The PIC is intended primarily for use by trained emergency responders, trained in advanced life support, cardiac care techniques, interpretation of ECG waveforms, and the use of the PIC. The usage may be in an ambulance or at the scene of an emergency. The PIC is also intended for use by (or on the order of) physicians at the scene of an emergency or in a hospital emergency room, intensive care unit, cardiac care unit, or other similar areas of a hospital. It is also intended to be used during the transport of patients between any of the locations mentioned above. The patient population will consist of adults and children (described below), and will consist of patients both with and without heart dysfunction. The PIC will be used primarily on patients experiencing symptoms of cardiac arrest or in a post trauma situation. It may also be used whenever it is required to monitor any of those functions that are included (as options) in the device. Indications for each of the specific functions are discussed below: DEFIBRILLATOR FUNCTION: The defibrillator function of the PIC is used to treat: ventricular fibrillation and pulseless ventricular tachycardia. Patients may range from neo-natal to adult. DEFIBRILLATOR (INTERNAL PADDLE) FUNCTION: With internal paddles, the defibrillator function of the PIC is used for the termination of ventricular fibrillation during cardiac surgery, with the paddles applied directly to the heart. Patients may range from neo-natal to adult. ECG MONITOR FUNCTION: The ECG monitor function of the PIC is used to monitor and/or record ECG waveform and heart rate, and to alarm when heart rate is above or below limits set by the operator. The PIC also provides output signals for the purpose of sending ECG waveforms to a remote monitor via direct connection, telephone, or radio transmission. Patients may range from neo-natal to adult. EXTERNAL TRANSCUTANEOUS PACEMAKER FUNCTION: The external transcutaneous pacing function of the PIC is used for the emergency treatment of hemodynamically compromising bradycardia, bradycardia with escape rhythms that are unresponsive to pharmacologic therapy, refractory tachycardia (supraventricular or ventricular), and bradyasystolic cardiac arrest. Patients may range from pediatric to adult. NON-INVASIVE BLOOD PRESSURE FUNCTION: The non-invasive blood pressure function of the PIC is used to make non-invasive measurements of arterial pressure and heart rate, and to alarm if either parameter is outside of the limits set by the user. Measurements are made using an inflatable cuff on the patient's arm or (occasionally) leg. Patients may range from pediatric to adult. TEMPERATURE MONITOR FUNCTION: The temperature monitor function of the PIC is used to make continuous measurements of rectal, esophageal, or surface temperature, and to alarm if the temperature is outside of the limits set by the user. It is used on patients ranging from neo-natal to adult. PULSE OXIMETER FUNCTION: The pulse oximeter function of the PIC is used to monitor pulse rate and oxygen saturation of arteriolar hemoglobin, and to alarm if either parameter is outside of the limits set by the user. It is used on patients ranging from neo-natal to adult. Measurements are made non-invasively at remote sites such as a finger, toe, ear lobe, bridge of nose, etc. It is used on patients ranging from neo-natal to adult. RESPIRATION RATE MONITOR FUNCTION: The respiration rate monitor function of the PIC is used to continuously monitor respiration rate and to alarm if the rate falls outside of the range set by the operator. The patients range from neo-natal to adult. Because the measurement method actually measures respiratory effort, apnea episodes with continued respiratory effort (such as obstructive apnea) may not be detected. It is not intended to be used as an apnea monitor. It is used on patients ranging from neo-natal to adult.

CardioServ is intended to be used for the emergency resuscitation of cardiac arrest victims and clinical cardiac dysrhythmia. CardioServ is intended to be used by trained operators CardioServ is designed for external and internal defibrillation (including cardioversion) CardioServ is capable of monitoring the heart rate with adjustable alarm limits. CardioServ is designed for external pacing with adjustable current and frequency. The intended use of CardioServ is identical to the intended use of the predicate devices.

CardioServ is a portable defibrillator with ECG monitor, built-in recorder, and the capability of external pacing with adjustable current and frequency.

Responder 2500 is intended to be used in a hospital environment by emergency personnel in evaluating and treating life-threatening arrhythmias. ♦ Responder 2500 is intended to be used by trained operators ♦ Responder 2500 is designed for external and internal defibrillation (including cardioversion) ♦ Responder 2500 is capable of monitoring the heart rate with adjustable alarm limits. ♦ Responder 2500 is designed for external pacing with adjustable current and rate.

Responder 2500 and Cardiac Care System is an emergency cardiac monitor/defibrillator with an external pacing option.