Cordiana Medical Informatics AG 0160100 Cordiana Dx16

The VidiStar PACS & DICOM Viewer Software system is a picture archiving and communications system (PACS) intended to be used as a networked Digital Imaging and Communications in Medicine (DICOM) and non-DICOM information and data management system. The VidiStar PACS & DICOM Viewer Software is comprised of modular software programs that run on standard “off-the-shelf” personal computers, business computers, and servers running standard operating systems. VidiStar PACS & DICOM Viewer Software system is an image, data storage and display software that accepts DICOM data from laboratories, which support DICOM standard imaging data and structured reporting transfer(s). The system provides the capability to: organize images generated by OEM vendor equipment, perform digital manipulation, create graphical representations of anatomical areas, perform quantitative measurements, and create DICOM structure reports, all over the Internet.

The HealthView ECG Manager is a computer system, used within a clinical network, which is intended to be used by trained professionals. It provides the ability to retrieve, store, edit, send, and print ECGs and related digitized clinical documents through the use of on-screen measurement and editing tools. The system receives files (such as ECG, Stress, Holter, or PFT) from any compatible device, displaying such data to the clinician for analysis and review.The product does not modify the original ECG waveform and does not provide an automated ECG analysis.

The ECG Cable is an accessory to the PURE EP™ System. The ECG cable Assembly (4.8m) connects to standard ECG patches on the patient’s skin. The cable connects directly to the blue plug on the amplifier (aka MSU - Main System Unit).The PURE EP™ is a system that consists of two main parts: the amplifier (aka MSU - Main System Unit),and the personal computer (PC), which are connected over a highspeedfiber optic cable. The patient is connected to the amplifier viaa set of supplied ECG cables and commercially availableintracardiac (IC) catheters. The amplifier includes hardware andembedded software necessary for acquiring ECG and IC signalsfrom patients. The device is not intended for active patientmonitoring. It consists of one ECG and seven IC modules designedto acquire 12-lead ECG and 56 IC signals and send the digitizeddata to the PC. The PC has preinstalled PURE-EP software and isconnected to display monitors. The pre-installed software providesvisualization of received data from the amplifier on real-time andreview screens. It also includes a signal processing module thatprovides various filter options for real-time and review screens.

The ECG Check is intended for self-testing by patients at home. This 1-leadcardiac monitor allows remote patients to display and transmit their EGG data tomedical professionals via a communication device to a remote server.Specifically, the EGG Check is indicated for patients who are concerned abouttheir heart rhythm and have experienced the following symptoms that aresuggestive of abnormal heart rhythms:* Skipped Beats* Pounding Heart (Palpitations)* Heart Racing or Irregular Pulse* Lightheadedness or Faintness* History of ArrhythmiasPrescription

The VidiStar PACS & DICOM Viewer Software system is a picture archiving and communications system (PACS) intended to be used as a networked Digital Imaging and Communications in Medicine (DICOM) and non-DICOM information and data management system. The VidiStar PACS & DICOM Viewer Software is comprised of modular software programs that run on standard “off-the-shelf” personal computers, business computers, and servers running standard operating systems. VidiStar PACS & DICOM Viewer Software system is an image, data storage and display software that accepts DICOM data from laboratories, which support DICOM standard imaging data and structured reporting transfer(s). The system provides the capability to: organize images generated by OEM vendor equipment, perform digital manipulation, create graphical representations of anatomical areas, perform quantitative measurements, and create DICOM structure reports, all over the Internet.

The HealthView ECG Manager is a computer system, used within a clinical network, which is intended to be used by trained professionals. It provides the ability to retrieve, store, edit, send, and print ECGs and related digitized clinical documents through the use of on-screen measurement and editing tools. The system receives files (such as ECG, Stress, Holter, or PFT) from any compatible device, displaying such data to the clinician for analysis and review.The product does not modify the original ECG waveform and does not provide an automated ECG analysis.

The ECG Cable is an accessory to the PURE EP™ System. The ECG cable Assembly (4.8m) connects to standard ECG patches on the patient’s skin. The cable connects directly to the blue plug on the amplifier (aka MSU - Main System Unit).The PURE EP™ is a system that consists of two main parts: the amplifier (aka MSU - Main System Unit),and the personal computer (PC), which are connected over a highspeedfiber optic cable. The patient is connected to the amplifier viaa set of supplied ECG cables and commercially availableintracardiac (IC) catheters. The amplifier includes hardware andembedded software necessary for acquiring ECG and IC signalsfrom patients. The device is not intended for active patientmonitoring. It consists of one ECG and seven IC modules designedto acquire 12-lead ECG and 56 IC signals and send the digitizeddata to the PC. The PC has preinstalled PURE-EP software and isconnected to display monitors. The pre-installed software providesvisualization of received data from the amplifier on real-time andreview screens. It also includes a signal processing module thatprovides various filter options for real-time and review screens.