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The use of CardioDirect is indicated when it is desired to record and interpret an electrocardiogram of a patient. This includes a resting electrocardiogram, a rhythm electrocardiogram, or a stress electrocardiogram (such as might be taken during an exercise stress test).

CardioDirect is a 12-lead digital electrocardiograph with interpretation of the electrocardiogram based on a standard personal computer. It can also be used for a stress test if purchased with the proper interfaces. CardioDirect, when used as an electrocardiograph, has a special interface unit between the external connections (ECG electrodes, treadmill and blood-pressure device) and the computer. It permits either manual or automatic interpretation of electrocardiograms.

The Reynolds CardioCollect is a small, portable rechargeable-battery-powered digital electrocardiograph that is intended to be used by technicians to acquire 12-lead ECG's from up to 40 patients, and then print them or store them digitally in the patient's record in a computer (or both). The unit prints by direct connection to a printer. The unit meets all specifications for 12-lead electrocardiographs and has a provision for entry of patient data using its keypad.

CardioCollect is a small, portable rechargeable-battery-powered digital electrocardiograph that is intended to be used by technicians to acquire 12-lead ECG's from up to 40 patients, and then print them or store them digitally in the patient's record in a computer (or both). The unit prints by direct connection to a printer. Typical recording time is ten seconds; all leads are recorded prince. Typical "recording" time "is "is "ifications for 12-lead electrocardiographs. It has a provision for entry of patient data using its keypad. Records include basic data on patients (name, number, and date of birth) as well Records morade basis and these can be printed with the tracing.

The Reynolds Lifecard CF 7-Day Holter recorder is a modification of the Reynolds Lifecard CF Holter Recorder, K001025. It is indicated when it is desired to record the patient's ambulatory electrocardiogram. It is a portable Holter recorder designed to record the patient's ambulatory electrocardiogram for up to seven days.

The device is a portable Holter recorder designed to record the patient's ambulatory electrocardiogram for up to seven days (with the appropriate flashcard and battery). The unit uses a data compression system to store seven days of ECG data in extended mode. In "standard" mode (up to two days of recording) the unit is identical to the predicate device.

The EventStation is intended to be used as a central receiving station for electrocardiograms that are recorded by Patient-Activated cardiac event recorders and then transmitted by telephone to a central station. It can operate in either an automatic "Unattended Mode" or a manual "Attended Mode." It has no ECG analysis capability, and is not intended to be used for this purpose. The system can also download the contents of Reynolds event recorders directly by means of a cable. It is not intended to display pacemaker activity.

The EventStation enables the physician to receive and review ECG recordings transmitted by the patient from a Reynolds CardioCall event recorder and other compatible event recorders. The EventStation consists of a personal computer with voice modem, operating under Windows 98, and special software written by Reynolds Medical Ltd. The computer is assembled by Reynolds from standard components, and has been modified so that the operating system cannot be changed and unauthorized software cannot be loaded.

The event recorder, called the "CardioCall," 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 described to him by his physician. The CardioCall can either operate in the so-called "Looping" mode, in which it is always active, and in which it records a minute of one channel of cardiac activity before and a minute after the depression of the button; or in the "Post-Activation" mode, in which the device records two channels of cardiac activity for one minute after the depression of the record button. The PC computer program, called the "CardioConnect," is indicated when it is desired to transfer the memory of the event recorder into a computer by direct connection, instead of using transtelephonic means. The CardioCall recorder is indicated if it is desired to record the electrocardiogram at the time when a patient experiences intermittent or transient symptoms such as dizziness, palpitations, or shortness of breath, and the patient is capable of activating the recorder at these times.

CardioCall Event Recorder offers the user the choice of a looping cardiac event recorder (records the electrocardiogram both before and after the event) or a post-activation recorder (records the electrocardiogram only after the event). Inserting the patient cable automatically changes the system from post-activation to looping. Embedded electrodes in the case are used for post-activation recording. The unit records one channel in looping mode and two channels in post-activation mode, and has a maximum recording time of 20 minutes. In looping, the unit records ten events with one minute before and one minute after the event. Recordings can either be transmitted transtelephonically to a central station equipped with a standard transtelephonic receiver, or downloaded directly into a PC with the CardioConnect software, available as an option. The unit features a special battery conservation mode, to conserve battery power. While the device is compatible with a number of transtelephonic systems (the requirements are in the instruction book), all transtelephonic testing was done with the PaceArt receiving station.

The Reynolds Pathfinder 700 Holter Analyzer is intended to be used to analyze magnetic tapes of ambulatory electrocardiograms made on compatible Holter Recorders. The system will detect various arrhythmias and will measure ST elevation or depression. The system acts in both an automatic mode (tape analyzed without operator intervention) and in an interactive mode (operator can intervene and affect analysis).

The Pathfinder 700 Holter ECG analyzer is a high-speed Holter cassette analyzer capable of analyzing tapes recorded at 1.47 mm/second and 1.0 mm/second as well as solid-state recorders such as the Reynolds eRAM and the Braemar DL700. It is a successor to the Reynolds Pathfinder 3 analyzer, marketing of which has been approved by the FDA under 510 (k) number K871344. The unit features arrhythmia analysis, ST analysis, pacemaker beat deviation detection, and determination of beat types, in both an automatic and interactive mode. The system uses an icon-based, mousecontrolled, Graphical User Interface ("GUI"), visually similar to those found on the well-known Apple and Windows operating systems. Analysis is performed at 1000 times the recording speed, obtained by using parallel computations and a 188 megabyte random-access memory, in addition to a 1000 megabyte hard disk. Thus a 24 hours lible megabyte hard disk. Thus, a 24 hour Holter tape can be analyzed in approximately 1.5 minutes. A 486 motherboard is used to provide disk control and keyboard/mouse interfacing, while the analysis sections use parallel computing, based on the T400 and T425 transputers, a computer element which forms the basis of many parallel computing systems. Pathfinder system is mouse-controlled, and uses a cathoderay tube display and keyboard. The analysis is based on the Neilson principle or algorithm, which have been used on the previous Reynolds analyzers, and which have received in all approval. The backs and which have received 510(k) approval. The basic principles of the analysis are the same as those used previously by Reynolds; the new features of this system lie principally in its new electronic features, which have led to re-programming the equations and analysis principles.