Principles used by the device to generate device output

The device senses the lead 1 ECG and radial artery pulse by using 3 electrodes (1 as RA, 1 as LA, 1 as RL) and 1 pressure sensor. With the aforementioned bio-signal, the device can get certain parameters, including pulse transmission time (PTT), and calculates SYS and DIA respectively according to a formula. The devices can also calculate heart rate (HR) and indicates irregular heart beat as well.

Intended use of the device
  • The device is used to monitor the blood pressure and is helpful to those with hypertension disease. It may be applied to the population from age 20 to age 80, for both male and female.
  • Since the device has to sense the radial artery pulse, it must be applied to left wrist with handheld by right hand.
  • The device can be measured anytime the users intend to do so, as long as the device is operated correctly.
  • The measurement result (SYS/DIA/HR) is for reference only and cannot be used as diagnosis basis. Users have to consult doctors for further interpretation and treatment.
  • The device will be sold over the counter with no prescription required.
  • How the device interacts with other device or with the user
    The device can be used standalone as a blood pressure monitor, and it can upload the data to a PC/smart-phone via USB/Bluetooth respectively.
    Explanation of the material used in the device
  • ECG electrodes: all 3 are gold-plated or platinum-plated (both are bio-compatible)
  • Pulse sensor: force sensor encapsulated with silicon rubber, which is also a bio-compatible material.
  • Mechanical: It includes a bottom case, a mid-frame, and a top lens.
  • Electronic: PCB with active and passive components powered by a rechargeable battery
  • Display: back-light LCD