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The Switched Internal Paddles are intended for use with HeartStart defibrillators to defibrillate the heart during open-chest surgical procedures.

The Switched Internal Paddles are used for defibrillation during open-chest (intrathoracic) procedures. These paddles have a shock button located on the right-hand paddle shown in Figure 5-1. This shock button allows the user to deliver a defibrillation shock holding the paddles to discharge the defibrillator remotely. The reusable switched internal paddles are shipped non-sterilized by the health care provider prior to each patient use. These switched internal paddles are accessories to compatible Philips HeartStart Defibrillators as detailed in Table 5-1, and are identified by the M47xxA series model numbers (where "xx" is a variable integer), as listed below in Table 5-1. These paddles can be used on adult and pediatric populations per the indications for use of the compatible defibrillators.

The TEMPUS LS - MANUAL is a multi-function, portable of providing defibrillation therapy, noninvasive external pacing, displaying ECG, and CPR feedback in hospital settings. It is to be used by qualified medical health care professionals trained in the use and operation of the device and qualified by training in advanced cardiovascular life (ACLS) support. Manual Defibrillation: In Manual Defibrillation mode, the TEMPUS LS - MANUAL is indicated for victims of cardiac arrest where there is apparent lack of circulation as indicated by these three conditions: Unconsciousness, Absence of breathing, and Absence of pulse. This product should be used only by qualified medical personnel for terminating ventricular fibrillation and ventricular tachycardia. Defibrillation is indicated for adult and pediatic patients. When a victim is less than 8 years of age, or weighs less than 55 lbs. (25kg), the TEMPUS LS - MANUAL should be used with the Tempus Pediatric Electrodes or in the device's pediatic mode with the Tempus Adult Electrodes. Therapy should not be delayed to determine the patient's exact age or weight. Cardioversion: The TEMPUS LS - MANUAL may be used for synchronized cardioversion to terminate atrial fibrillation (AF) or ventricular tachycardia (VT) by using the R-wave of the patient's ECG as a timing reference. A qualified user trained in the operation of the device must decide when synchronized cardioversion is appropriate. Cardioversion is indicated for adult and pediatric patients. External Pacing: The TEMPUS LS - MANUAL is indicated for temporary external cardiac pacing in conscious or unconscious patients as an alternative to endocardial stimulation. The purposes of pacing include: Resuscitation from standstill or bradycardia of any etiology. As a standby when standstill or bradycardia might be expected. External pacing is indicated for adult and pediatric patients. ECG Display: The TEMPUS LS - MANUAL is intended to display a patient's ECG from a 3- or 4- lead wire ECG patient cable. It is indicated for use in adult or pediatric for attended monitoring of the patient's ECG signal (e.g., before starting demand pacing or after successful defibrillation). CPR Feedback: The TEMPUS LS - MANUAL may be supplied with an optional CPR feedback sensor, which is intended to provide visual and audio feedback to encourage rescuers to perform CPR in accordance with AHA/ERC guidelines for chest compression rate and depth. It is indicated for use on adult and pediatric patients ≥ 8 years of age or weighing ≥ 25 kg / 55 lbs. CPR Feedback is not indicated for use on neonatal and pediatric patients under 8 years of age or weighing less than 25 kg/55 lbs.

The TEMPUS LS – MANUAL is a compact, lightweight, portable electromedical device that contains a direct current (DC) defibrillator capable of delivering up to 200 joules of electrical energy to a patient through selfadhesive external electrode pads. The device is intended for use by advanced cardiac life support (ACLS) trained health care professionals in hospital settings to provide defibrillation therapy, non-invasive external pacing, cardiopulmonary resuscitation (CPR) feedback, and non-alarming electrocardiograph (ECG) monitoring. The device is intended for prescription-use only. The unit is powered by a rechargeable lithium-ion battery which is recharged when connected to a mains power supply. The unit incorporates a color LCD display that displays information related to a clinical intervention. The trained user may select an energy level between 1 - 200 ioules and deliver a shock in either an asynchronous mode of delivery or through synchronized cardioversion using the patient's R-wave as a timing reference for the shock. The device provides non-invasive transcutaneous pacing in either fixed or demand modes of operation through the same self-adhesive pads used in manual defibrillation. In addition, the device incorporates an audible metronome to quide a user as to the correct rate at which chest compressions should be administered in accordance with current American Heart Association (AHA) resuscitation guidelines. The device may be supplied with an optional cardiopulmonary resuscitation (CPR) feedback sensor which assists caregivers during CPR in delivering chest compressions at a rate and depth in compliance with current AHA guidelines. The device may also be paired to a compatible external device via a secure wireless communications protocol called Tempus Data Link (TDL) to export event data (without patient identifiers) at the convenience of the user.

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. 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.

The Sterilizable Internal Defibrillation Paddles is an accessory designed to be used with biphasic LIFEPAK defibrillator/monitors during open heart cardiac surgery. The Sterilizable Internal Defibrillation Paddles are intended for use by highly-trained medical professionals to internally detect electrocardiogram (ECG) rhythm and deliver internal defibrillation and synchronized cardioversion therapy directly to the surgically exposed heart. This accessory consists of metal paddle electrodes, and molded plastic handles with discharge control (located on the right handle) which connects directly to the defibrillator. The Sterilizable Internal Defibrillation Paddles accessory requires sterilization before initial use and after each use, per the Sterilizable Internal Defibrillation Paddles Instructions for Use.

To remove excessive hair prior to placement of defibrillator electrodes.

The Rapid Hair Removal Pads ("RHRP") are intended to be used by medical professionals prior to the placement of DC-Defibrillator, Low Energy electrodes to remove excessive chest and side torso hair from a victim of sudden cardiac arrest. This hair can significantly impede the defibrillator's performance in analyzing the heart's rhythm and delivering an appropriate shock. The primary mechanism of the RHRP is a high-tack adhesive that removes hair from the sites on the chest and side torso on which these electrodes are to be placed, prepping the site for optimal electrode-to-skin contact. RHRP is a single-use product and can be disposed of with other emergency single-use equipment. To use the RHRP, the user removes the pads from the outer packaging, peels the pads sequentially off the non-stick PET liner backing, and places the adhesive side of the pad at two sites—on the chest and side torso-where the defibrillator electrodes will be placed. The user presses the pads on firmly to adhere them to the hair and skin at those sites. The user then pulls the pads quickly away from the skin in the opposite direction of hair growth. The resulting area is left substantially cleared of hair, decreasing impedance and increasing electrode-to-skin contact.

Defibrillator Function: The E Series ALS products contain a DC defibrillator capable of delivering up to 200 joules of energy. It may be used in synchronized mode to perform synchronized cardioversion by using the R-wave of the patient's ECG as a timing reference. The unit uses paddles or disposable, pre-gelled, MFE Pads for defibrillation. The E Series ALS products must be prescribed for use by a physician or medical advisor of an emergency response team. Intended Use — Manual Operation: Use of the E Series ALS products in the Manual mode for defibrillation is indicated on victims of cardiac arrest where there is apparent lack of circulation as indicated by these three conditions: Unconsciousness, Absence of breathing, and Absence of pulse. This product should be used only by qualified medical personnel for converting ventricular fibrillation and rapid ventricular tachycardia to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats. In Manual mode, the E Series ALS unit may also be used for synchronized cardioversion to terminate atrial fibrillation (AF) or ventricular tachycardias (VT) by using the R-wave of the patient's ECG as a timing reference. A qualified physician must decide when synchronized cardioversion is appropriate. Intended Use - CPR Monitoring: The CPR monitoring function provides visual and audio feedback designed to encourage rescuers to perform chest compressions at the AHA/ERC recommended rate of 100 compressions per minute. Voice and visual prompts encourage a minimum compression depth of at least 1.5 (3.8 cm) or 2.0 inches (5.0 cm), depending on the configuration, for adult patients. The CPR monitoring function is not intended for use on patients under 8 years of age. Intended Use - Pacemaker: This product may be used for temporary external cardiac pacing in conscious or unconscious patients as an alternative to endocardial stimulation. Note: This device must not be connected to internal pacemaker electrodes. The purposes of pacing include: Resuscitation from standstill or bradvcardia of any etiology, As a standby when standstill or bradycardia might be expected, Suppression of tachycardia. Pediatric Pacing: Pacing can be performed on pediatric patients weighing 33lbs / 15kg or less using special ZOLL pediatric MFE Pads. Prolonged pacing (in excess of 30 minutes), particularly in neonates, could cause burns. Periodic inspection of the underlying skin is recommended. Monitor Intended-Use Multi-parameter Monitoring: This product may be used for monitoring various patient vital signs, including: electrocardiogram (ECG), Pulse Oximetry (SpO2), Carboxyhemoglobin (SpCO), Methemoglobin (SpMet), End Tidal CO2, 12-Lead ECG, and Non-Invasive Blood Pressure (NIBP). ECG monitoring is performed by connecting the patient to the 3 or 5 lead patient cable, MFE Pads, or through the paddles. SpO2 monitoring is indicated for detecting arterial oxygen saturation of blood and pulse rate for adult, pediatric and neonatal patients who are well or poorly perfusing, during both no motion and patient motion conditions. SpCO monitoring is indicated for detecting carbon monoxide concentration in arterial blood for adult, pediatric and neonatal patients who are well or poorly perfusing, during both no motion and patient motion conditions. SpMet monitoring is indicated for detecting oxidized hemoglobin concentration in arterial blood for adult, pediatric and neonatal patients who are well or poorly perfusing, during both no motion and patient motion conditions. EtCO2 monitoring is indicated for the continuous measurement of end tidal carbon dioxide (EtCO2) and respiration rate for adult, pediatric and neonatal patients. 12 Lead ECG analysis is indicated for the diagnosis and treatment of adult and pediatric patients with acute myocardial infarction or other cardiac arrhythmias. NIBP monitoring is indicated for the measurement of arterial blood pressure for resting adult, pediatric, and neonatal patients.

The predicate ZOLL E Series External Defibrillator/Monitor reviewed and cleared by the FDA (K111594 and K092598) is intended for use by qualified medical personnel who are trained and authorized to respond to medical emergencies, to facilitate the ability to monitor and assess the physiological characteristics of the indicated patients in a critical care environment. It combines the function of a manual defibrillator, noninvasive transcutaneous pacer. ECG monitor, pulse oximeter, end tidal CO2 monitor. 12-Lead EGG monitor, non-invasive blood pressure monitor and CPR performance monitor along with data printing and recording capabilities. Functions are offered as options, and functions can be configured during manufacturing to meet the needs of a particular application. Through a manufacturing configuration option that is already available in the device's software and currently offered for distribution (reviewed and cleared by FDA under K111594), the ECG rhythm analysis (advisory) option can be disabled during the manufacturing of the device. This creates a manual-only/ non-AED configuration of the device which is marketed as E Series ALS and intended to be used by ACLS qualified personnel. On the hardware side, the front panel that is offered with this configuration does not include the analyze button that is used to initiate ECG rhythm analysis.

The Cardio Med Pediatric Radiotranslucent Multifunction Electrodes, Various Models are indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single patient use only. The 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 pediatric patients whose weight is less than 10 kg (22 lbs). 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 (30 joule maximum).

These are single use, non-sterile, self stick defibrillator electrodes packaged in pairs. Effective electrode area = 46.43 cm² (7.1967 in²) They are radiotranslucent. They come in various connector styles to match the specific defibrillator. (See intended use statement below.) The construction and materials employed are identical to the predicate. The patient contact material is a conductive adhesive hydrogel identical to the material used in the predicate devices. These pads meet the AAMI Standard ANSI/AAMI DF80:2003 and the connectors meet the FDA performance standard for touch proof ECG connectors.

EURO DEFI PADS series of disposable multi-function electrodes are indicated for the following clinical applications: - external defibrillation - synchronized cardioversion - cardiac stimulation - ECG monitoring EURO DEFI PADS series of disposable multi-function electrodes provide the conductive interface between the defibrillator and the patient's skin. These devices are available with different connectors compatible for use with different defibrillators. All devices are non-sterile and for single-use only. The pediatric model of EURO DEFI PADS disposable multi-function electrodes is intended for use on pediatric patient under eight years of age, or weighting less than 25 kg, the device is designed to deliver a maximum of 100 joule. The adult model of EURO DEFI PADS disposable multi-function electrodes is intended for use on adult patients and children older than eight years or greater than 25 kg, the device is designed to deliver a maximum of 360 joule. The radio-transparent adult model EURO DEFI PADS disposable multi-function electrodes for adult patient use only, is well suited for certain clinical applications involving radiographic viewing.

FIAB EURO DEFI PADS series of disposable multi-function electrodes are made by a couple of pre-gelled self-adhesive pad-type electrodes consisting of foam backing, laminated metallic substrate, conductive hydrogel, cabling and molded connector. The electrodes are passive devices providing the conductive interface between the defibrillator and the patient's skin. Each couple of electrodes is permanently attached with lead wires that join together in a safety connector suitable for direct connection to devices - both monophasic and biphasic of the main defibrillators brands nowadays present on the market. The products are packaged in pairs inside water-vapor proof, heat sealed, non-transparent, aluminum/PE pouches. FIAB EURO DEFI PADS series of disposable multi-function electrodes are available in the following versions: adult, adult radiotransparent, pediatric.

The Cardio Med DEFIBRILLATION/CARDIOVERSION/MONOPHASIC OR BIPHASIC PACING/ ECG ELECTRODES are indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single patient use only. The 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). Compatible with Cardiac Science (ANDERSON connectors), PHILIPS MEDICAL, PHYSIO-CONTROL, and ZOLL MEDICAL models of monophasic and bi-phasic defibrillators, external pacemakers.

These are single use, non-sterile, self stick defibrillator electrodes packaged in pairs. 104 cm² (16.1 in²) They are radiotranslucent. They come in various connector styles to match the specific defibrillator. (See intended use statement below.) The construction and materials employed are identical to the predicate. The patient contact material is a conductive adhesive hydrogel identical to the material used in the predicate devices. These pads meet the AAMI Standard ANSI/AAMI DF80:2003 and the connectors meet the FDA performance standard for touch proof ECG connectors.

The Cardio Med DEFIBRILLATION/CARDIOVERSION/MONOPHASIC OR BIPHASIC PACING/ ECG ELECTRODES are indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single patient use only. The 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). Compatible with Cardiac Science (ANDERSON connectors), PHILIPS MEDICAL, PHYSIOCONTROL, and ZOLL MEDICAL models of monophasic and bi-phasic defibrillators, external pacemakers.

These are single use, non-sterile, self stick defibrillator electrodes packaged in pairs. Effective electrode area = 98 cm2 (15.2 in2). They are radiotransparent. They come in various connector styles to match the specific defibrillator. The construction and materials employed are identical to the predicate. The patient contact material is a conductive adhesive hydrogel identical to the material used in the predicate devices. These pads meet the AAMI Standard ANSI/AAMI DF80:2003 and the connectors meet the FDA performance standard for touch proof ECG connectors.

The Propaq MD is intended for use by trained medical personnel who are familiar with basic monitoring, vital sign assessment, emergency cardiac care, and the use of the Propaq MD. The Propaq MD 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. The usage may be in an ambulance or at the scene of an emergency. It is also intended to be used during the transport of patients. The Propaq MD will be used primarily on patients experiencing symptoms of cardiac arrest or in 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. The Propag MD unit can be used on pediatric patients (as described in the following table) and on adult patients (21 years of age or older) with and without heart dysfunction. Manual Defibrillation: Use of the Propaq MD in the manual mode for external and internal defibrillation is indicated on victims of cardiac arrest where there is apparent lack of circulation as indicated by: Unconsciousness, Absence of breathing, Absence of pulse. This product should be used only by qualified medical personnel for converting ventricular fibrillation and rapid ventricular tachycardia to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats. The unit can also be used for synchronized cardioversion of certain atrial or ventricular arrhythmias. Qualified medical personnel must decide when synchronized cardioversion is appropriate. ECG Monitoring: The Propaq MD is intended for use to monitor and/or record 3-, 5-, or 12-Lead ECG waveform and heart rate, and to alarm when heart rate is above or below limits set by the operator. External Transcutaneous Pacing: This product can be used for temporary external cardiac pacing in conscious or unconscious patients as an alternative to endocardial stimulation. The purposes of pacing include: Resuscitation from standstill or bradycardia of any etiology; As a standby when standstill or bradycardia might be expected; Suppression of tachycardia; Pediatric pacing. Non-Invasive Blood Pressure Monitoring: The Propag MD is intended for use 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 leg. Temperature Monitoring: The Propaq MD is intended for use to make continuous temperature measurements of rectal, esophageal, or surface temperatures, and to alarm if the temperature is outside of the limits set by the user. Sp02 Monitoring: The Propaq MD is intended for use 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. Measurements are made non-invasively at remote sites such as a finger, toe, ear lobe, bridge of nose, etc. Respiration Monitoring: The Propaq MD is intended for use to continuously monitor respiration rate and to alarm if the rate falls outside of the range set by the operator. 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. CO2 Monitoring: The Propaq MD is intended for use to make continuous noninvasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and breath rate. Invasive Pressure Monitoring: The Propaq MD is intended for use to display and make continuous invasive pressure measurements from any compatible pressure transducer. The primary intended uses are arterial blood pressure, central venous pressure and intracranial pressure monitoring. Any contraindications of the particular transducer selected by the user shall apply.

The ZOLL Propaq MD was cleared by the agency under 510(k) application k100654 as a multi-parameter monitor / defibrillator / external transcutaneous pacer with the following capabilities: 3, 5 and 12-Lead ECG, pulse oximetery, non-invasive blood pressure, invasive blood pressures, CO2, temperature, data recording and printing. The device is designed for use by trained medical personnel in both out-of-hospital and inhospital applications. The proposed modification adds a filter (SmartCuf) to the existing NIBP algorithm that uses the existing ECG QRS detection to qualify the pressure pulses used in the device NIBP measurement.