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The HeartCheck ECG Pen with GEMS Home is a telemedicine based solution that is intended to enable adult patients to record, store, transfer and display single channel ECG waveforms while involved in everyday activities anywhere. The HeartCheck ECG Pen combined with GEMS Home enables the person to send their ECG recordings to a medical service for review and interpretation by a qualified health service professional such as a physician. GEMS Home use is not intended to substitute for a hospital diagnostic ECG test. The software and hardware are not intended for recording and transmission of user's ECG signal simultaneously. Patients with implanted pacemaker or defibrillator are not recommended to use this device. GEMS Home is a simple software user interface with ECG trace viewing function.

The applicant device HeartCheck ECG Pen is a handheld device, which can record cardiac event data and display the data in a clear and precise waveform. The ECG Monitor is made up of signal input unit, signal amplify unit, CPU, Display unit, power unit and storage chip. They are all in one PCB that is designed and made by our manufacturing partner Beijing Choice Electronic Technologies. The HeartCheck ECG Pen is activated by the user whenever symptoms are experienced. The recorded data serves as reliable evidence and are later shown to physicians or other health care professionals for confirmation of these symptoms. When a user feels that a cardiac event is occurring, the utilization of HeartCheck ECG Pen has the feature of recording this real time data that is normally difficult to capture. The applicant device has a "data upload" function which is controlled by hardware; it can transmit the data measured by the device to a computer via the USB port. The GEMS Home software is used to store and review the data collected by the HeartCheck ECG Pen Monitor. The GEMS Home software is installed onto the computer from a CD ROM by the user. The GEMS Home software CD ROM is an accessory of the applicant device. The applicant device has low battery voltage indication function. 2 AAA batteries supply the power for the monitor.

The HeartCheck™ Pen Handheld device with GEMS Home software is an over-thecounter device intended to record, store, transfer single channel Heart Rhythm signals and, for users under a physician's care, display Heart Rhythm waveforms. The HeartCheck™ Pen Handheld device along with GEMS Home software is not intended to substitute a hospital diagnostic ECG device. The device is not intended for simultaneously recording and transmitting a user's Heart Rhythm. Users with an implanted pacemaker or a defibrillator are not recommended to use this device. GEMS Home is a simple software user interface for managing Heart Rhythm recordings and associated data.

The applicant device of HeartCheck Pen is a handheld device. which can record cardiac event data. As delivered to the end user. Heart Rhythm recordings are made on the HeartCheck™ Pen Heart Rhythm device and uploaded to GEMS Home, but the Heart Rhythm Waveform itself is not visible to or accessible by the user. GEMS Home allows the user to manage their personal information, their Heart Rhythm recordings and upload their Heart Rhythm recordings for Physician Review. Once the end user is under the guidance of a qualified Health Care Professional (e.g. Physician. Trained Technician. etc.), the Health Care Professional can use the access-controlled "Physician Review" section of the existing CardioComm Solutions Rx Only devices to initiate a process to "unlock" the GEMS Home Software and the HeartCheck™ Pen Heart Rhythm device to allow the end user to see their Heart Rhythm Waveforms in the GEMS Home software and on the device. Access to the "Physician Review" component of the existing CardioComm Solutions Rx Only devices is restricted to Health Care Professionals. The "unlock" feature is not accessible to anyone other than qualified Health Care Professionals and can only be initiated once the user has uploaded their collected HR Data from the GEMS Home. The Heart Rhythm Monitor is made up of signal input unit, signal amplify unit. CPU. Display unit, power unit and storage chip. They are all in one PCB that is designed and made by our manufacturing partner Beijing Choice Electronic Technologies. The HeartCheck™ Pen Heart Rhythm device is activated by the user whenever symptoms are experienced. The recorded data serves as reliable evidence and can be later uploaded for review by qualified Health Care Professionals for confirmation of these symptoms. The applicant device has a "data upload" function which is controlled by hardware; it can transmit the data measured by the device to a computer via the USB port. The "GEMS Home" software is used to store and review the data collected by the HeartCheck Pen Heart Rhythm Monitor. The "GEMS Home" software is installed onto the computer from a CD ROM by the user. The "GEMS Home" software CD ROM is an accessory of the applicant device. The applicant device has low battery voltage indication function. 2 AAA batteries supply the power for the monitor.