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The M5 Recorder is indicated for use on patients who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light headedness, pre-syncope, syncope, fatigue, chest pain and/or anxiety. The M5 Recorder is intended for use by adults and all pediatric subgroups (weighing more than 10 Kg).

The M5 Recorder is a small, lightweight ambulatory electrocardiograph (ECG) recorder that records ECG continuously. The M5 records 1 or 3 channels of ECG up to 21 days. The battery duration of the M5 is dependent on the configured settings of sample rate and channel selection. The device is composed of the ECG recorder that can be utilized with a patch electrode or with a patient cable lead set using off the shelf electrodes intended for long-term monitoring. The device snaps onto the patch electrode or patient cable lead set and automatically begins recording. The recording will continue until either the M5 completes the programmed monitoring session, is removed from the Patch Electrode or patient cable, or the battery is depleted. At the end of the recording, the device can be plugged into a PC via the M5 USB cable. The ECG recording can be transferred to a PC where processing software can transfer the data to a format that can be processed through recording processing software provided by recording processing software manufacturers and analyzed by qualified healthcare providers. The M5 recorder acquires ECG data and does not perform any data processing or arrhythmia analysis of the ECG data. Only the M5 Recorder is part of this 510K application. During the recording period the patient wears the M5 Recorder with the patch electrode on the upper chest near the sternum. If using the M5 Recorder with the patient cable, the patient will wear off the shelf electrodes (2 - 5) positioned on the torso. The M5 Recorder can be worn continuously up to 14 days with the same patch electrode and up to 4 days with the patient cable and same set of off the shelf electrodes. The M5 Recorder consists of a microprocessor, measuring circuit, memory, data storage, light emitting diode (LED), and contacts to the electrode. In addition to that, the M5 Recorder contains firmware to control the collection of the ECG data and allows transfer to the processing software. The M5 Recorder has an internal Bluetooth radio that may be utilized with a host ambulatory ECG analysis system (such as the Global Instrumentation M12A application) to allow the qualified health care provider a view of the patient's ECG immediately following hook-up. The LED on the M5 Recorder will flash. This provides visual confirmation to the professional that the recorder is actively collecting data. The M5 recorder also has a button on the recorder. The primary function of the button is to provide an event feature where the patient presses the button on the recorder when they feel a symptom. The LED will flash to provide feedback to the patient that the event marking has occurred. The button also allows for a battery status check. The associated spare parts that are part of the M5 Recorder system are the M5 Patch Electrode, M5 Patient Cable, M5 USB Cable, and GI Wall Charger.