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This device is indicated for use in stimulation lead system analysis prior or during implantation of an electrical stimulator (pacemaker, pulse generator), for emergency stimulation and for high-rate (burst) stimulation limited to temporary diagnostic and therapeutic application.

PSA™ Series devices are portable pacing system analyzers, which are intended to be used for the evaluation of the integrity and most beneficial placement of stimulation leads. The integrity of a stimulation lead system is characterized by its electrical impedance, the measurement results of which shall meet the specifications of the manufacturer of the lead system. The most beneficial placement of a stimulation lead system is determined by the ability of the PSA Series device to capture the heart rhythm (successful stimulation) and to measure reasonable high amplitudes of P and/or R waves and corresponding slew rates. The PSA™ Series encompasses a single-channel device (PSA 100) and dual-channel device (PSA 200) with each channel employing a differential stimulation output and a differential sensing input. Stimulation leads or extension cables are connected to patented receptacles accommodating pins of 0.9 ... 2 mm or Hypertronics ™ style sockets. In addition to the aforementioned intra-cardiac channels, a PSA Series device offers an additional channel and corresponding terminal for a 5-lead surface ECG. The user interface is divided into a touch screen and an array of four keys dedicated to the functions: On / Off, Emergency, High-Rate, Home. The user monitors device measurements, heart activity and device status through the touch screen and LED indicators. Functions provided by PSA™ series pacing system analyzers are organized into so called applications such as (availability depending on PSA Series model): 1/A (Single-chamber stimulation (Channel 1/A)), 2/RV (Single-chamber stimulation (Channel 2/RV)), DDD (Atrioventricular (dual-chamber) stimulation), UHS (Burst stimulation (Universal Heart Stimulator)). By choosing one application, the (touch) screen displays all functions and information relevant to the specific application. The screen displays with minimal delay a marker signal and up to four signal waveforms all of which a user can select from the group of up to three IEGM signal waveforms (1/A, 2/RV; availability depending on PSA model) and seven surface ECG standard vectors (I, II, III, aVR, aVL, aVF, V). The device provides or facilitates the following measurements: Sensing of intrinsic events of the heart: P/R wave amplitudes and slew rate, Rates (PP, RR interval), Intrinsic AV delay (antegrade conduction time), Retrograde conduction time, Wenckebach point (2:1 conduction). Stimulation of the heart: Capture threshold in up to 2 chambers, Lead impedances, Burst stimulation. During an implantation procedure a PSA™ Series device can temporarily take over the functions of a cardiac pacemaker. Measurement results can be stored to a virtual print-out page, which upon completion of all measurements is transmitted wirelessly to a separate printer or computer. User-configurable settings for general use of the device and individual applications are stored in non-volatile memory. The HIGH-RATE function (dedicated key below the touch screen) provides bust stimulation at rates variable from 70 to 1,000 ppm for terminating atrial and ventricular tachycardia. The (optional) UHS application is special form of the high rate function. Within the UHS application, the user can program a train of burst prior to clinical application, which is also referred to as programmable electrical stimulation (PES). Pressing the EMERGENCY key (dedicated key below the touch screen) immediately initiates an emergency stimulation (VVI, 60 ppm, 7.5 V, 1.0 ms). Pressing the HOME key allows the user to return to the home screen (main menu). The device can operate from line power or the integrated rechargeable battery which provides up to 4 hours of continuous operation. A medical-grade AC power supply is part of the delivery unit. An integrated backup battery maintains stimulation in the unlikely event of a failure of the integrated rechargeable battery or AC power. The robust device enclosure is protected against accidental fluid spill.

The ICON® is intended for noninvasive continuous monitoring of hemodynamic parameters for adult, pediatric, and neonatal patients in hospitals, hospital-type facilities, mobile, and home environments under the care of a physician, nurse or medical technician.

The ICON® is a noninvasive cardiac output monitor, also known as a hemodynamic monitor. By application of an array of adhesive ECG type surface electrode to the body, the ICON® measures thoracic electrical bioimpedance (TEB) and in particular the changes of bioimpedance related to the cardiac cycle. The ICON® determines hemodynamic parameters related to blood flow, contractility and fluid status.

The AESCULON®, AESCULON® CHF Clinic™, AESCULON® Hypertension Clinic® and AESCULON® Pacemaker Clinic Fare intended for noninvasive continuous monitoring of hemodynamic parameters for adult, pediatric, and neonatal patients in hospitals, hospital-type facilities, mobile, and home environments.

The AESCULON® Version C2, including the models CHF Clinic™, Hypertension Clinic™ and Pacemaker Clinic™, is a noninvasive comprehensive cardiovascular monitor, also known as a hemodynamic monitor. By application of an array of adhesive ECG type surface electrode to the body, the AESCULON® measures thoracic electrical bioimpedance (TEB) and in particular the changes of bioimpedance related to the cardiac cycle. The AESCULON® determines hemodynamic parameters with respect to blood flow, vascular system (if the NIBP option is incorporated), contractility and fluid status.

The AESCULON®, AESCULON® CHF Clinic™, AESCULON® Hypertension Clinic™ and AESCULON® Pacemaker Clinic™ are intended for noninvasive continuous monitoring of hemodynamic parameters for adult, pediatric, and neonatal patients in hospitals, hospital-type facilities, mobile, and home environments.

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The PACE 101 / PACE 101H / Model 3077 SSI Temporary Pulse Generator is designed to be used with cardiac pacing lead systems for temporary atrial or ventricular pacing. - When combined with a stimulation lead system, the PACE 101 / PACE 101H / Model 3077 SSI Temporary Pulse Generator can be used whenever temporary atrial or ventricular pacing is indicated. The device can be employed for therapeutic as well as diagnostic purposes or may be used prophylactically. - Specific indications for temporary pacing include, but are not limited to: - . Complete (third-degree) or intermittent heart block; - Symptomatic sinus bradycardia; . - Atrial and/or ventricular ectopic arrhythmia; . - . Sick Sinus Syndrome (SSS); - Atrial tachyarrhythmia; - Acute myocardial infarction-induced heart block; . - Stimulation during ventricular asystole; ● - . Use during the replacement of an implantable pulse generator; - Stimulation and monitoring before the implantation of a cardiac pulse generator; ● - Stimulation and monitoring following heart surgery. .

The PACE 101 / PACE 101H / Model 3077 SSI Temporary Pulse Generator is used for temporary intensive care pacing of the heart in cases of rhythm disturbances and conduction defects, including: • Treatment of bradycardia • Treatment of atrial tachyarrhythmia • Treatment of special causes of acute myocardial infarction • Pre-, intra- and postoperative pacing of the heart. The PACE 101 / PACE 101H / Model 3077 can be used as either an intracardiac signal-inhibited pulse generator or as an asynchronous pulse generator. Pacing rate and amplitude can be adjusted over a wide range, conforming to actual therapeutic requirements. Sensed intrinsic activity and paced pulses are indicated optically by a light-emitting diode (LED). Additionally, acoustic signals for sensing and pacing can be switched on and off. The PACE 101 / PACE 101H / Model 3077 has two modes of high-rate pacing for the treatment of atrial tachycardia. Pacing frequency can easily doubled or quadrupled; the PACE 101 / PACE 101H / Model 3077 will then pace in asynchronous mode. An acoustic signal is automatically emitted during high-rate pacing. Errors that occur during operation are indicated optically and acoustically. A special circuit allows for automatic surveillance of the battery voltage. With the help of an LED and an acoustic signal, complete drainage of the battery can be prevented. The PACE 101 / PACE 101H / Model 3077 has an additional feature - run-away protection. Run-away protection limits the impulse emission to a maximum of 200 ppm and prevents the delivery of too high a pacing rate in the event of a defect in the frequency generator. The XI Series™ Extension Cables support proper connection of the PACE 101 / PACE 101H / Model 3077 to various types of pacing lead systems (accessories). The AS Series™ Arm Straps ensure proper attachment of the PACE 101 / PACE 101H/Model 3077 to the patient's arm (accessory).

The PACE 101 / PACE 101H / Model 3077 SSI Temporary Pulse Generator is designed to be used with cardiac pacing lead systems for temporary atrial or ventricular pacing. When combined with a stimulation lead system, the PACE 101 / PACE 101H / Model 3077 SSI Temporary Pulse Generator can be used whenever temporary atrial or ventricular pacing is indicated. The device can be employed for therapeutic as well as diagnostic purposes or may be used prophylactically. Specific indications for temporary pacing include, but are not limited to: - . Complete (third-degree) or intermittent heart block; - . Symptomatic sinus bradycardia; - Atrial and/or ventricular ectopic arrhythmia; . - . Sick Sinus Syndrome (SSS); - Atrial tachyarrhythmia; ● - Acute myocardial infarction-induced heart block; . - Stimulation during ventricular asystole; ● - Use during the replacement of an implantable pulse generator; . - Stimulation and monitoring before the implantation of a cardiac pulse generator: . - Stimulation and monitoring following heart surgery. .

The PACE 101 / PACE 101H / Model 3077 SSI Temporary Pulse Generator is used for temporary intensive care pacing of the heart in cases of rhythm disturbances and conduction defects, including: • Treatment of bradycardia • Treatment of atrial tachyarrhythmia • Treatment of special causes of acute myocardial infarction • Pre-, intra- and postoperative pacing of the heart. The PACE 101 / PACE 101H / Model 3077 can be used as either an intracardiac signal-inhibited pulse generator or as an asynchronous pulse generator. Pacing rate and amplitude can be adjusted over a wide range, conforming to actual therapeutic requirements. Sensed intrinsic activity and paced pulses are indicated optically by a light-emitting diode (LED). Additionally, acoustic signals for sensing and pacing can be switched on and off. The PACE 101 / PACE 101H / Model 3077 has two modes of high-rate pacing for the treatment of atrial tachycardia. Pacing frequency can easily doubled or quadrupled; the PACE 101 / PACE 101H / Model 3077 will then pace in asynchronous mode. An acoustic signal is automatically emitted during highrate pacing. Errors that occur during operation are indicated optically and acoustically. A special circuit allows for automatic surveillance of the battery voltage. With the help of an LED and an acoustic signal, complete drainage of the battery can be prevented. The PACE 101 / PACE 101H / Model 3077 has an additional feature - runaway protection. Run-away protection limits the impulse emission to a maximum of 200 ppm and prevents the delivery of too high a pacing rate in the event of a defect in the frequency generator. The Series XI Extension Cables support proper connection of the PACE 101 / PACE 101H / Model 3077 to various types of pacing lead systems (accessories). The Series AS Arm Straps ensure proper attachment of the PACE 101 / PACE 101H / Model 3077 to the patient's arm (accessory). The aforementioned devices are stand-alone devices that provide temporary atrial or ventricular demand or asynchronous pacing therapy. The aforementioned devices are battery powered. Indicator lights flash to show atrial and ventricular sensing and atrial and ventricular pacing functions. The PACE 101 / PACE 101H / Model 3077 is equipped with insulated connector terminals matching the protected pins of the Series XI Extension Cables and meets the 21 CFR Part 898 performance standard.

The PACE 203 / PACE 203H / MODEL 3085 external pulse generator / temporary pacemaker is designed to be used with cardiac pacing lead systems for temporary atrial or A-V sequential pacing. The PACE 203 / PACE 203H / MODEL 3085 has applications where such pacing modes are indicated for therapeutic, prophylactic, or diagnostic purposes. Specific indications include, but are not limited to, the following: - Sick Sinus Syndrome; - Bradycardia with congestive heart failure; - Complete heart block; - Acute myocardial infarction complicated by heart block; - Sinus bradycardia; - Cardiac arrest with ventricular asystole; - Atrial and/or ventricular ectopic arrhythmia; - Postoperatively after cardiac surgery; - Temporary application during implantation or exchange of permanent pacemaker. Indication for atrial overdrive stimulation (rapid atrial pacing): - Supra-ventricular tachycardia. The PACE 203 / PACE 203H / MODEL 3085 can be used to measure atrial or ventricular voltage stimulation thresholds and determine the approximate P wave potentials sensed via the atrial pacing lead electrodes and the approximate R wave potentials sensed via the ventricular pacing lead electrodes. The XI.TME and XI.RAC Extension Cables are used with external pulse generators / temporary cardiac pacemakers and pacing system analyzers.

The PACE 203 / PACE 203H / MODEL 3085 is a dual-chamber external cardiac pacemaker with atrial controlled timing for routine temporary heart stimulation. Synchronous and asynchronous modes of atrial, ventricular and A-V sequential stimulation are available for treatment of acute brady-arrhythmia and for pre-, intra-, and post-operative stimulation of the heart. The stimulation parameters are easily adjustable by rotating dials through a wide range of values. The PACE 203 / PACE 203H / MODEL 3085 offers the possibility for atrial overdrive stimulation, or rapid atrial pacing, for terminating supra-ventricular tachycardia. The rate of the overdrive stimulation is adjustable within a wide range and is independent of the selected stimulation rate. The overdrive rate can be determined before and changed during overdrive therapy. If required, overdrive stimulation can be initiated with the touch of a button. The overdrive stimulation is indicated optically and acoustically. The battery operated device can be affixed to the patient's arm by the arm strap included. The housing is protected against accidental liquid spills. The functional design of the PACE 203 / PACE 203H / MODEL 3085 allows safe and easy operation with regards to all requirements of DDD stimulation. The PACE 203 / PACE 203H / MODEL 3085 further offers the following features: • During battery changes, stimulation will be maintained for at least 30 s. • A non-volatile memory keeps any desired stand-by program ready for use, even if the device is shut off. • A standard program, which can be individualized, is available for each primary pacing mode. • An emergency program can be "called up" by pressing an emergency key. • A burst- and a ramp function are available for atrial overdrive-stimulation. • An Unlock/Lock button protects against accidental change of the set parameters. • The set parameters and (error) messages are shown on a liquid crystal display. • The detection of the intrinsic heart activity as well as the emission of stimulation impulses are shown separately by blinking LEDs for both atrium and ventricle. Additionally, a beep-tone can be switched on whenever desired. • System malfunctions that occur are indicated optically and acoustically. • A lead surveillance system indicates interruptions and short circuits. • When a battery change is required, optical and acoustic alerts are provided. • During dual chamber pacing, an automatic mode for adapting A-V delay, maximum tracking rate (MTR), and PVARP is available. • An automatic mode for adjusting the sensitivity in both the atrium and ventricle may be chosen. • A Pause function is available for easy determination and measurement of the patient's intrinsic heart activity. The Series XI Extension Cables support proper connection of the PACE 203 / PACE 203H / Model 3085 to various types of pacing lead systems (accessories). The Series AS Arm Straps ensure proper attachment of the PACE 203 / PACE 203H / Model 3085 to the patient's arm (optional accessory).