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The REKA E100 EGG Event Recorder (Cardiac Rhythm Monitor) is intended for use by patients who may be at risk for experiencing transient cardiac symptoms that could suggest cardiac arrhythmia. The device records the patients EGG on demand at any time the patient feels any physical symptoms indicative of a potential heart event. A 30 second single channel ECG is recorded and transmitted to a monitoring center. The monitoring center provides the EGG data to the medical practitioner for evaluation. The Indications for Use are the same as the predicate devices. The device is a handheld, personal electrocardiograph unit, which can measure electrical activities of the heart easily and conveniently. It is immediately available at any time to manually record transient cardiac events, suitable for home health care use, and which can record and store an ECG signal, and then transmit the ECG recording to a hospital or cardiology center for interpretation and review. It is suitable for adult users, who suffer from cardio-vascular diseases, are considered at high risk for potential cardiovascular events or other adult people who are concerned about their heart function and rhythm as they move about during their daily life. This device is not intended for use as a conventional diagnostic tool, but is to be used as a healthcare patient evaluation tool which can provide a doctor with the recorded ECG data as a reference to help detect and analyze heart events that a patient may experience at any time or any place.

The REKA E100 ECG Event Recorder (Cardiac Rhythm Monitor) is designed for on-demand, self-recording of a single channel ECG by patients at almost any place and any time. The recording takes 30 seconds and is transmitted to backend website for analysis and interpretation by medical professionals of the remote Monitoring Center. ECG signals are acquired by the two (2) built-in finger electrode sensors on the device. As an alternative, a better quality ECG can be recorded using the 2-leadwire cable with 2 electrodes pasted on body. The acquired signals are recorded in a build-in NAND flash memory and E100 can store up to 4000 ECG records. The recorded EGG data can be transferred to mobile phone using micro USB cable/ 30-pin cable provided. The ECG then can be transmitted via cellular link or WiFi to an Internet depository when the patient ECG records are filed. The Internet depositories compatible with E100 can be accessed via www.reka.net and www.rekahealth.com. The compatible smart cell/mobile phones that can upload ECG records from E100 include iPhone®, Blackberry®, Symbian® and smart phones running on Android™. These mobile phones will require to install E100 Uploader (Apps) developed by REKA, the user can easily download the Apps from App World, Android Market etc. and install it. Alternatively, the EGG signals stored in E100 can be transmitted to backend website through PC or Laptop with Internet connection by plugging E100 to computer using USB cable. For computer with Windows® & Mac®, user can easily access to the corresponding Uploader apps pre-stored in the device to run it for installation at 1ª time use. After then the Uploader runs automatically once E100 is plugged in. For computer with Linux®, user can directly upload ECG data by clicking the apps, no installation required.