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The TX3 Cardiac Event Recorder, called the TX3, is intended to be worn by the patient and to record a short period of electrocardiogram when the patient detects symptoms indicated to him by his physician. It is indicated when such recordings are required for diagnosis, prognosis, and management of transient symptoms such as dizziness, syncope, palpitations, and arrhythmias.

The TX3 Cardiac Event Recorder is intended to record samples of a patient's electrocardiograph (ECG) when indicated by the patient, store the ECGs in a temporary storage, and then to be transmitted to a central station by the patient, by telephone. The unit has two modes: Post-event and Arrhythmia, or "Looping.". In post-event mode, the unit records a period of ECG following the pressing of a button by the patient. The unit can also determine the pulse duration of implanted pacemakers in Post-Event mode. In arthythmia mode, the unit is a so-called "looping recorder." it is always active, and thus records a sample of ECG both before and after the "patient event." The unit records a 3-lead ECG, using four electrodes. Normally, the unit records the limb leads. The Central Station unit is the Paceart WINCPTS 86-12 system (K915632). The physician can program the unit and set the number of recordings and the duration of the recording that can be made before they must be transmitted to the central station.

The HomeTrak Plus Cardiac Twelve-Lead Event Recorder is a patient-activated ambulatory cardiac event monitor and associated central-station receiving equipment which are to be used for recording infrequent and elusive heart arrhythmias and transmitting them by telephone at a later time to a central analysis center, with the ability to record three electrocardiographic leads or to derive 12 electrocardiographic leads from the three transmitted.

The HomeTrak Plus Cardiac Twelve-Lead Event Recorder is a patient-activated ambulatory cardiac event monitor and associated central-station receiving equipment which are to be used for recording infrequent and elusive heart arrhythmias and transmitting them by telephone at a later time to a central analysis center. It records three electrocardiographic leads and derives 12 electrocardiographic leads from the three transmitted. When the five electrodes are attached to the patient in the special configuration shown in the manual and the PaceArt WINCPTS central-station software with 12-lead option is used, the physician can either record a twelve-lead electrocardiogram or a three-lead electrocardiogram at the analysis center. The system for derivation of the 12-lead electrocardiogram from the five-electrode recording is called the "EASI" system. There are two elements to the Home Trak Plus system: a "looping" cardiac event recorder, and a special central-station program.

The event recorder, called the "Heart Access Plus," is intended to be worn by the patient and to record a short period of electrocardiogram when the patient depresses a button upon sensing symptoms indicated to him by his physician. The unit is intended to be used in the patient's home, place of work, or when traveling. Recordings are then to be transmitted telephonically to a central receiver, where they are printed as received and then can be interpreted by a physician. The unit also has a voice diary so that the patients can record notes of the circumstances when the event was recorded. The Heart Access Plus operates in the so-called "Looping" mode, in which it is always active, and in which it records an interval of one channel of cardiac activity before and an interval after the depression of the button; durations of the intervals are programmable. The intended patient population is patients experiencing intermittent and unexpected cardiac events and arrhythmias.

The Paceart "Heart Access Plus"™ combines a "looping" cardiac event recorder and a voice diary. The feature permits the device to record a sample of the electrocardiogram both before and after the patient senses a symptom of a cardiac event and presses the "activator" button, unlike many other recorders which only record the ECG for a period after the sensing of the symptom. The voice diary permits a patient to record the circumstances which led to his making a recording. The number and duration of events are programmable by the physician. The device can record up to 270 seconds of electrocardiogram. Each event can be programmed for 5 to 50 seconds of "pre-history" ECG (ECG before the activator button is pressed) and 5 to 95 seconds of "post-history" ECG (after the activator button is pressed). There can be one or two channels (two electrodes per channel, placed as desired) and up to six events: the total duration of all of the events for all of the channels is limited by the total record time of 270 seconds. The device will not permit programming more events than can be stored, and once the memory is full no more electrocardiograms can be recorded. The voice diary permits recording up to 90 seconds of notes.

Paceart Wrist Electrodes are intended to be used for home monitoring of pacemaker patients via telephone monitoring systems.

Paceart Wrist Electrodes are metallic electrodes with elastic wristbands intended for electrocardiographic monitoring. Physically the device consists of a flat metallic electrode fastened to a familiar metallic expansion band of the type commonly used with wrist watches. Ordinarily, the patient would have one electrode and band on each wrist. Each electrode has attached to it a single cable, attached to a connector with an oversized pin. The cable is used to provide the connection to the monitor. No gel or other skin preparation is indicated, and in general is not necessary: the patient slips on the bracelet so that the electrode is on the inside of the wrist, and connects the cable connector to a jack on the monitor. The plug is of sufficiently large diameter so that it will not fit into a power outlet. The wrist electrode is used for home telephonic monitoring purposes, and in general will be in contact with the skin for a maximum of five minutes; it is not intended for use as a general-purpose electrocardiographic electrode or for long-term monitoring.