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The Paceart System is intended for use as a 12-lead electrocardiograph, pacemaker artifact analyzer, and transtelephonic ECG receiving station. It also acts as a database for cardiac patients with or without pacemakers or Implantable Cardioverter Defibrillators.

The Medtronic Paceart Optima System Software, Model POS12D, is intended for use with the Medtronic Paceart System, previously cleared per K024278. The Paceart System is a 12-lead electrocardiograph, transtelephonic receiving station, and a clinic management tool that organizes patient, device and programmer information. The Paceart System is designed to integrate data from implanted cardiac device programmers, pacemaker transmitters, cardiac event recorders, and remote data networks, such as the Medtronic CareLink® Network, into a single patient record, enabling clinicians to conduct their daily work through commonly formatted data and clinic workflow tools. Note: The Paceart System will also be marketed and referred to as the Paceart Optima System when using the Paceart Optima System Software. The Paceart System consists of hardware and software. There are no design or process changes to the hardware components of the Paceart System as part of this submission. Therefore, the subject of this 510(k) submission is for the Paceart Optima System Software only and contains only information on the software changes.

- The device is for prescription use only. - The device is intended to be used in a clinic or hospital. - The device is intended for use by the physician (or his/her representative), not by the patient, although one intended use is to record the patient's 12-lead ECG. - The device is intended for use as a : Fully functional ECG/heart rate monitoring system for clinical use. Pacemaker Detection and measurement. A TTM (trans-telephonic) Receiving Station. - In TTM mode, the device is intended for use with landline analog and digital PBX telephone systems only. It is not intended to be used with wireless networks.

Cygnus 12 Lead/TTM ECG module is a fully functional ECG and Pacemaker monitoring system that is powered through a PC USB (Universal Serial Bus) port. Four general parts could be distinguished in the Cygnus 12 Lead/TTM ECG module: - An analog front end. - Digital Signal Processing USB Interface Unit. - TTM Interface for analog phone lines. - TTM Interface for digital phones. The module measures the 12 standard ECG leads on the isolated input, and is capable of acting as an ECG Receiving Station over the phone line for ECG and pacemaker encoded signal with Frequency Modulation (FM).

The Paceart System is intended for use as a 12-lead electrocardiograph, pacemaker artifact analyzer, and transtelephonic ECG monitor. It also acts as a database for pacemaker and implantable cardioverter defibrillator patients.

The Medtronic Paceart® System is a personal computer based pacemaker-testing system, a 12-lead electrocardiograph, and a transtelephonic receiving station. It provides data that can be used to analyze implanted pacemaker performance based on electrocardiographic measurements, either taken directly from the patient or programmer. The system can measure, store, and display any of the 12 standard leads. Reports and charts are available by means of a laser printer. The system also includes a database that collects and stores patient data. Optional software allows the device to function as an unattended transtelephonic receiving station.