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The intended use of the device is to acquire and record the 3 different types of heart bio-signals (ECG, PCG, and MCG) and combine the results into a contiguous presentation as an aid to diagnostic interpretation by a Physician in a clinical setting. The indication for use is as ... a. a Standard 12 Lead Diagnostic ECG b. an aid to identify events in the cardiac cycle c. an aid to detect S1 & S2 hearts sounds and murmurs. Any diagnostic interpretation is only significant when used in conjunction with physician over-read as well as consideration of all other relevant patient data. The Cardio-TriTest is on a prescription basis by a Certified Medical Practitioner.

The Cardio-TriTest v6.5 (CTT) is three devices in one; combining a 12-Lead Electrocardiograph (ECG), a 4 Lead Phonocardiograph and a 4 lead Mechanocardiograph. The device will acquire all three types of bio-signals during the same non-invasive test procedure. The three types of signals are synchronized and outputted on the same timeline making it easier for general practitioners to visually determine a patient's current heart health. The ECG component is a Standard 12-Lead ECG, conformant with EN IEC 60601-2-25 standards. The CTT v6.5 device uses approved Standard 12-Lead FDA/CE cables. The CTT includes 4 Kombi-Sensors that include combine PCG/MCG functionality. The PCG component consists of 4 electronic stethoscopes into one Phono recording device. PCG sensors are equipped with diaphragms and non-chill rings. The MCG component consists of 4 MCG recording devices integrated into the Kombi-Sensor housing (PCG and MCG in same Sensor Housing). The PCG and MCG signal verification can be found in Annex E - Signal Testing. The PCG and MCG sensors are housed in common sensor housing, Kombi-Sensor, this allows the Kombi-sensor of being positioned/located in one of the 4 standard auscultation points on the thoracic wall. The combined PCG/MCG sensors record their signals when positioned on the four primary auscultation points on the thoracic wall.

The intended use of this device is to acquire and record 3 different types of heart bio-signals (ECG, PCG, MCG) and combine the results into a contiguous presentation as an aid to diagnostic interpretation by a Physician in a clinical setting. The indication for use is as ... a. a Standard 12 Lead Diagnostic ECG b. an aid to identify events in the cardiac cvcle c. an aid to detect S1 & S2 hearts sounds and murmurs. Not intended for use in pediatrics. Not intended for patients in the intensive care units. Intended population: Males and females greater than or equal to 20 years of age. Any diagnostic interpretation is only significant when used in conjunction with physician over-read as well as consideration of all other relevant patient data. The Cardio-TriTest is on a prescription basis by a Certified Medical Practitioner.

The Cardio-TriTest is three devices in one, combining a 12-Lead Electrocardiograph (ECG), a Phonocardiograph and a Mechanocardiograph. The device will acquire all three types of bio-signals during the same non-invasive test procedure. The three types of signals are synchronized and outputted on the same timeline making it easier and more visual for general practitioners to visually determine a patient's current heart symptoms. The ECG component is a Standard 12-Lead ECG, conformant with IEA60601-2-25 standards. The Cardio-TriTest device for catching ECG signals uses Standard 12-Lead FDA/CE approved ECG cables by Sino-Hero Company. The PCG component consists of 4 electronic stethoscopes combined into one Phono recording device. PCG/MCG sensors are with FDA/CE approved diaphragms and soft non chill rings manufactured by the Riester Company from Germany. The MCG component consists of 4 MCG recording devices. The MCG signal validation is in the Annex B of this application. The PCG and MCG sensors are housed in common sensor housing for the purpose of being positioned/located on the thoracic wall in the same four (4) primary and standard auscultation points. The combined PCG/MCG sensors are correctly positioned on the four primary auscultation points on the thoracic wall via a purpose designed harness.