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The clue medical and clue medical BASIC are handheld, battery operated single channel electrocardiographs intended for recording and transmitting ECG data by patients who are concerned about their heart rhythm. The clue medical and clue medical BASIC allow the patient to record their ECG data into the device memory and transmit it for display by healthcare professionals. Specifically, the clue medical and clue medical BASIC are intended for patients that are concerned about their heart rhythm or have experienced the following symptoms that are suggestive of abnormal heart rhythm: Skipped beats Pounding heart (palpitations) History of arrhythmia The clue medical and cluc medical BASIC ECG data is intended to be used by a licensed health care practitioner. These measurements are not intended for any specific clinical diagnosis. The clinical significance must be determined by the physician.

The clue medical is an handheld battery operated single-channel ECG recorder featuring four fixed electrodes on the back of the device, an ECG lead connector, an IrDA and a Bluetooth interface and one single button to record and store up to ten ECG recordings with 30 seconds or two minutes duration. The stored ECG tests are processed into a printable Portable Document Format (PDF) that can be transmitted two ways. The PDF can be transmitted via IrDA or Bluetooth to an IrDa or Bluetooth capable local PC or printer. If the receiving device is not IrDa or Bluetooth capable, an optional IrDA USB stick is provided with the clue medical. The PDF file can then be saved, sent, displayed or printed. Alternatively, the PDF can be transmitted via a Bluetooth capable cell phone directly to the Telovital server for storage. The device requires that a user is mentally and physically capable of reading and understanding the Patient Operating Instructions. The patient must also be physically capable of pressing the record button and holding the device to his/her chest for an adequate reading. The clue medical BASIC is identical to the clue medical in design. The only difference is that the clue medical BASIC does not provide the added capability of sending the ECG data via cell phone directly to the Telovital server, it is only capable of transmission to a local PC or printer. The purpose of this Special 510(k) is to modify the method of wireless data transmission for both the clue medical and clue medical BASIC to include Bluetooth technology.

The clue medical and clue medical BASIC are handheld, battery operated single channel electrocardiographs intended for recording and transmitting ECG data by patients who are concerned about their heart rhythm. The clue medical BASIC allow the patient to record their ECG data into the device memory and transmit it for display by healthcare professionals. Specifically, the clue medical and clue medical BASIC are intended for patients that are concerned about their heart rhythm or have experienced the following symptoms that are suggestive of abnormal heart rhythm: Skipped beats Pounding heart (palpitations) History of arrhythmia The clue medical and clue medical BASIC ECG data is intended to be used by a licensed health care practitioner. These measurements are not intended for any specific clinical diagnosis. The clinical significance must be determined by the physician.

The clue medical is an handheld battery operated single-channel ECG recorder featuring four fixed electrodes on the back of the device, an ECG lead connector, an IrDA interface and one single button to record and store up to ten ECG recordings with 30 seconds or two minutes duration. The stored ECG tests are processed into a printable Portable Document Format (pdf) that can be transmitted two ways. The pdf can be transmitted via IrDA to an IrDA capable local PC or printer. If the receiving device is not IrDA capable, an optional IrDA USB stick is provided with the clue medical. The pdf file can then be saved, sent, displayed or printed. Alternatively, the pdf can be transmitted via an IrDA capable cell phone directly to the Telovital server for storage. The clue medical BASIC is identical to the clue medical in design. The only difference is that the clue medical BASIC does not provide the added capability of sending the ECG data via cell phone directly to the Telovital server, it is only capable of IrDA transmission to a local PC or printer.