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· The System is intended to derive, display and print a derived 12 lead ECG as well as the X, Y, Z leads from the acquisition of just 3 leads (5 electrodes).The System also has the capability to acquire the standard 12 lead ECG using the standard 10 electrodes and convert the ECG signal into a digital format. · The 12 lead interpretive software is a windows-based program intended to interpret electrocardiograms. The software receives, displays and stores a single, three or standard 12 lead simultaneous ECG recording, which is transmitted either locally or transtelephonically from an ECG monitor using a proprietary digital data transmission protocol. The device contains proprietary software algorithms to receive, store, analyze and interpret the 12 lead ECG signal only. · In 5 electrode mode, the System analyzes data from 3 leads (5 electrodes) and produces visual and audible alarms for ECG changes that may be consistent with 12-lead ECG signs of Acute Myocardial Ischemic Injury (AMII), including Acute Myocardial Infarction (AMI).This mode is not intended to be a sole means of diagnosis, but prompts, the user to acquire a standard 12 lead ECG (using 10 electrodes) for interpretation by a physician when the Cardian Electrical Biomarker (CEB®) is 95 or greater. Monitoring patients with a CEB® is only indicated for patients presenting with chest pain or other presumed anginal equivalents. · The interpretation software is only available for the standard 12 lead ECG utilizing the standard 10 electrodes. · The System is intended to be used by healthcare professionals, or trained personnel where ECG monitoring /acquisition is indicated for hospitals and/or clinics. · The System can be used within electro-surgical environments. · Device is for Adult use.

The Universal SmartECG is a device with 10 lead wires attaching to electrodes on a patient's chest and one wire connecting to a computer. The system is able to display, store, and print a 12 lead ECG with 10 electrodes attached to the patient. In addition, The Universal SmartECG incorporates the VectraplexECG software (K102378), to derive up to a 15 lead (standard 12 leads and Frank vector X, Y, and Z leads) ECG from only three measured leads (5 electrodes). The device also monitors, in real-time, ECG changes that may be indicative of acute myocardial ischemic injury, including AMI*, via a displayed index number, the Cardiac Electrical Biomarker (CEB; VectraplexAMI). The system also provides the vector loops. The System's derivation algorithm is able to provide additional information based on geometric principals relating to the placement of electrodes on the body. The Cardiac Electrical Biomarker (CEB) is produced based on an algorithm accounting for the multipolar contributions of the electrical field around the heart, which was FDA cleared via K102378.

• Vectraplex® CMS in a Central Monitoring System intended to transfer information between networked devices (only VectraplexECG Systems), which include hard-wired or wireless devices • The Central Monitoring System can be used for remote monitor management, printing, viewing or otherwise processing of information from VectraplexECG Systems including remote control • The device is intended to be used by qualified medical professionals • The Vectraplex CMS will audibly and visually alarm if the VectraplexECG System's CEB® (VectraplexAMI), Cardiac Electrical Biomarker, reaches an alarm condition. • The Vectraplex CMS' intended use population consists of those patients with certain medical conditions in whom continuous cardiac monitoring is considered to be a medical necessity in the judgment of the ordering healthcare provider. • The Vectraplex CMS is intended for centralized monitoring of patients through a network in hospitals, Emergency Departments and Surgical Centers, doctor's offices, and urgent care facilities. • Not for home use

The Vectraplex CMS is a program that can allow a central monitoring system to view multiple VectraplexECG Systems through either an intranet or internet connection. There are three programs to the central monitoring system: the Monitor Agent, the Device Agent, and the Proxy Agent. The programs require Java version 1.7 or higher prior to installation. The Monitor Agent will remotely display and control another device's screen. The Device Agent (installed on the bedside monitoring device) will allow the Monitor Agent (remote central monitoring system) to access the Device Agent's system and control it on demand. The Proxy Agent is a "behind the scenes" program installed on a computer or server, running Windows 7 operating system, which integrates multiple systems (central monitoring system, bedside monitors) and allows them to communicate. The Monitor and Device Agents connect through the use of the Proxy Agent by utilizing a singular IP address, either through the internet or the intranet. Due to the separation of the Proxy Agent from the other systems, communication may occur over both intranet as well as internet connections. The maximum capacity of the Vectraplex CMS is a total of 16 devices. Each Proxy Agent can withstand a maximum load of 16 devices displayed on 3 different monitors. These 3 monitors are duplicates of the same 16 devices.

- VectraCor's VectraplexECG System with VectraplexAMI analyzes data from 3 leads (5 electrodes) and produces visual and audible alarms for ECG changes that may be consistent with 12-lead ECG signs of acute myocardial infarction. The device does not provide a diagnosis of acute myocardial infarction, but prompts the user to acquire a standard 12 lead ECG (using 10 electrodes) for interpretation by a physician. Monitoring patients with VectraplexAMI is only indicated for patients presenting with chest pain or other presumed anginal equivalents. - The VectraplexECG System is intended to derive, display and print a derived 12 lead ECG as well as the X, Y, Z leads from the acquisition of just 3 leads (5 electrodes). The System also has the capability to acquire the standard 12 lead ECG using the standard 10 electrodes. The interpretation software is only available for the standard 12 lead ECG utilizing the standard 10 electrodes. - VectraplexECG is intended to be used by healthcare professionals, i.e. Physicians, Nurses, Technicians, and Physician Assistants, where 12 lead and X, Y, Z leads are indicated for Hospitals and/or Clinics. - The 12 lead interpretive software is a windows-based program intended to interpret electrocardiograms. The software receives, displays and stores a single, three or standard 12 lead simultaneous ECG recording, which is transmitted either locally or transtelephonically from an ECG monitor using a proprietary digital data transmission protocol. The device contains proprietary software algorithms to receive, store, and interpret the 12 lead ECG signal only. - Device is for Adult use.

The VectraplexECG System will be able to display and print a 12 lead ECG with 10 electrodes attached. In Addition, VectraplexECG will be able to derive up to a 15 fead ECG from only three measured leads (5 electrodes) and monitor the ECG changes that may be consistent with 12 lead ECG signs of acute myocardial infarction, via a displayed index number, VectraplexAMI.