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Monitoring of stable patients, not at high risk for life-threatening anthythmias, after discharge from hospital stay, such as patients with compensated congestive heart failure, patients whose myocardial infarction is not recent, or patients with a stabilized heart condition following open heart surgery or coronary artery disease Monitoring of patients in out-of-hospital convalescence settings Monitoring of patients by physicians, clinics, or skilled care facilities Any time a health care professional desires monitoring, measuring or recording of a patient's ECG, SpO2, and/or blood pressure in an out of hospital residence setting The device is not intended to sound real time alarms This device does not replace physician's care

The LifeSigns!™ Cardiac Monitoring System collects vital signs data for diagnostic monitoring of stabilized patients, not at high risk for life-threatening arrhythmias, in an out-of-hospital environment. The monitored vital signs include ECG, SpO2, heart rate, and blood pressure. The LifeSigns System is comprised of a monitor (LifeSigns™Shuttle), a cradle (LifeSigns144 Commander), and central station software (LifeSigns™ Central Station). The Shuttle is a portable device, that acquires the patient ECG (one to 12 leads) using ECG electrodes, and the photometric SpO2 data, and heart rate. The Commander provides the non-invasive oscillometric blood pressure measurement (as an option), and connects the Shurtle to a telephone line. The Central Station software operates on an IBM compatible personal computer, coupled by a DSVD (digital simultaneous voice and data) modem to a telephone line. The software provides support for data collection from the monitor and cradle, and supports display, editing, reporting and management of the collected vital signs data, patient demographics, and other associated data. The DSVD capability allows simultaneous voice and data communications between the patient and the central station personnel and between the cradle and the PC. The device is not intended to sound real time alarms. The LifeSigns System does not replace physician's care.

Transtelephonic monitoring of arrhythmia and/or pacemaker implant patients that do not require emergency medical intervention. In-office acquisition and display of single and/or multi-lead ECG. Collection, storing, reporting, transfer, and management of patient(s) health information.

CardioMagic® 2000 Cardiac Monitoring System Software (CMS) is a productivity enhancing, office automation product. The intended users of CMS are physicians, clinics, and hospitals with cardiac patient follow-up and monitoring practices. CMS is a database software product, intended to involve competent intervention before any impact on health occurs. The software does not analyze the information. Clinical judgment and experience are required to check and interpret the printed reports, as part of the process of evaluating pacemaker performance, or patient ECG rhythms. There are no known contraindications for use of this device. CardioMagic software is installed on an IBM compatible personal computer, which may also be networked to other PC's. An Instromedix LifeSigns Receiving Center™ (LRC) may be attached to the PC, to acquire transmitted data and waveforms from transtelephonic pacemaker monitors and ECG event recorders. CardioMagic provides remote control of the LRC, presents the received waveforms and data on the computer screen, assists in editing, viewing, and organizing the received data, and provides database support for patient and device information, and provide reports.

These devices are intended for use by patients who need to record their ECG during daily activites for subsequent transmission to a clinic, service, or hospital. These patients may have been instructed by their physician to record their ECG for the purpose of documenting transient symptoms which may suggest cardiac arrhythmia. The telephonic use of these devices allows the patient to receive advice based on their ECG and symptoms in a timely manner. These devices are non-invasive, external ambulatory electrocardiographic (ECG) memory monitors. They are designed for evaluation of transient symptoms like dizziness, palpitations, and chest discomfort, and may be incorporated as part of rehabilitation, or medical treatment followup, where such symptoms may be present.

The accelerated transmission protocol may be used by transtelephonic ECG transmitters. This protocol allows the stored ECG data to be sent more rapidly over the communications link to the receiver. Three devices that incorporate the Advanced Transmission Protocol (ATP) are presented in this summary statement. They are the King Of Hearts, Express ATP. the King Of Hearts, Prince ATP, and the HeartCard ATP. These devices are non-invasive, external ambulatory electrocardiographic (ECG) memory monitors. They are designed for evaluation of transient symptoms like dizziness, palpitations, and chest discomfort, and may be incorporated as part of rehabilitation, or medical treatment followup, where such symptoms may be present. Features and functions are identified to the identified predicate devices with the addition of the ATP feature. The Accelerated Transmission Protocol feature does not play any part in the recording of ECGs. It is only active in the transmit mode. The ATP feature accelerates the transmission rate to 3 times the rate the data was acquired. The transmitters convert the data to an FM signal, which is sent to a receiver (LRC 2000 Receiver) designed to receive the ATP protocol. The receiver demodulates the FM signal back to the analog ECG waveform, and expands the received signal to the original scale by using an increased sampling rate (3x) and operating the chart drive at a 3x rate. The result is a chart strip showing the time scale of the original signal acquisition. The edge print on the ECG strip indicates that an accelerated transmission has been received from an Instromedix transmitter.