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The EMMa system is intended for diagnostic evaluation of patients who experience transient symptomatic events that may suggest non-lethal cardiac arthythmia to support and possibly improve an ongoing treatment by the patient's physician. Data received from battery powered ambulatory monitoring devices, triggered by an arrhythmia detection algorithm or manually by the patient, are stored and forwarded to licensed physician for review.

EMMa (Electronic Monitoring Management) is the server part of a telemedical system to receive data from the ambulatory ECG monitors Kate Loop (Event Monitor) and Kate MCT (Mobile Cardiac Telemetry; similar to Loop but with additional functions like trend data and streaming). Physiological data recorded by the ECG monitors are transmitted via their GSM module (cellular telephon network) to the server EMMa. The detection of arrhythmias and other cardiac conditions is done on the ECG monitoring device, not on the EMMA, and is not scope of this 510k. EMMa is provided to be installed in a Telemonitoring Service Centre (TSC). ECG-technicians / Agents working there generate patient reports from physiological data with the aim to send the reports to the patients' physicians. No interpretation of data is performed by the server software. The generated reports support physicians in adapting the therapy. EMMa is not designed for and compatible with iOS and Android.

Diagnostic evaluation of patients with asymptomatic disturbances of cardiac rhythm such as: -Dizziness -Heart race -Palpitation -Syncopesof unknown cause

The ECG monitoring devices are post-event recorders, also called tele-ECG devices, which realize one-channel (100BT) or three- channel (300BT) recordings of short ECG sections, their memorization as well as the preparation of the transmission. Therefore, the purpose of the recorders is the derivation and memorization of an ECG section in combination with a compatible telemedicine system. The recorder provides physicians with information used for the diagnosis of cardiac arrhythmias. The Post Event 300BT device is a modification to Vitaphone's previously cleared Post Event 110BT device cleared pursuant to K100383. The modification consists of the availability of three recording channels rather than one recording channel. There is no change to intended use, patient contact materials or core technology. The hardware of the 100BT and the 300BT is basically the same. The differences between both devices is the activation of the channels by the software. The device supports the transmission of the data. The recorders are battery operated devices. The recorders do not possess a separate on/off switch.

Diagnostic evaluation of patients with asymptomatic and symptomatic disturbances of the cardiac rhythm such as: – Dizziness - Heart race - Palpitations - Syncopes of unknown cause

The Vitaphone 100 BT device is single-channel cardiac event recorder for transmitting multiple ECG recordings via land-line or GSM telephony networks to a compatible ECG receiving system, such as REMOS ECG Receiving Software (510(k) K050670) or compatible ECG receivers. The Vitaphone 100 BT device is intended for patient activated event recordings. It is battery driven and utilizes a Flash memory to store ECG data with an adjustable event time.