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intended to measure the diastolic, systolic blood pressures and pulse rate of an adult individual who over the age of 12 in medical facilities or at home by using a non-invasive oscillometric technique with a single upper arm cuff (22-42 cm). The Subject device is not intended to be diagnostic device.

The device has four series : U87Y series (models including U80Y, U81Y, U82Y,U83Y,U86Y U80N, U81NH), U81X series (including U81X, U80X, U82X, U83X, U81D, U82D, U83D, U81RH, U82RH) , U83Z series (including U83Z, U80Z, U81Z, U82Z, U85Z, U86Z and U87Z) and U86E series (including U82E, U80E, U80EH, U81E, U83E, U85E, U80L, U87E ). All of them have same Indications for use and similar technological characteristics. All the models in the same series have the same electrical circuit design, PCB layout, critical components and internal wiring. The differences between the four series are the appearance design, circuit diagram and the PCB layout. All of them have the same working principles, software design and the similar technical specification. Urion Blood Pressure Monitor are designed to measure the systolic and diastolic blood pressure and pulse rate of an individual (at least 12 or above) by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic pressure sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well-known technique in the market called the "oscillometric method". The main components of the Blood Pressure Monitor are the main unit and cuff unit. ABS is used to outer housing of the main unit. The preformed cuff unit, which is applicable to arm circumference approximately between 220 and 420 mm, includes the inflatable bladder and nylon shell. All models of the arm blood pressure monitor use a single size of cuff.

Measure blood pressure (systolic and diastolic) and pulse rate.

Upper Arm Electronic Blood Pressure Monitor, Model U86E and TelliBP01 are designed to measure the systolic and diastolic blood pressure and pulse rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic pressure sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a wellknown technique in the market called the "oscillometric method". The main components of the Upper Arm Electronic Blood Pressure Monitor are the main unit and cuff unit. ABS is used to outer housing of the main unit. The preformed cuff unit, which is applicable to arm circumference approximately 22 cm to 42 cm, includes the inflatable bladder and fabric. The device consists of the main unit and cuff. The product is provided non-sterile, and not to be sterilized by the user prior to use. Model U86E and TelliBP01 in this submission follow the similar software, same measurement principle and similar specifications. The differences existed between different models included in this submission will not affect the safety and effectiveness of the device. The model U86E embed an Bluetooth Wireless network connections module that allows it to send data(systolic blood pressure, diastolic blood pressure, pulse rate) from blood pressure monitor to the Application in the external instruments. The TelliBP01 embed a SIM card, which can send data(systolic blood pressure, diastolic blood pressure, pulse rate) from blood pressure monitor to the Application in the external instruments through 4G network. The wireless functions of U86E and TelliBP01 only have data transmission function, without any control feature.

The U80 Series Upper Arm Electronic Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the upper arm. It can be used at medical facilities or at home. The intended upper arm circumference is 22-36cm.Suitable for adults who over the age of 12.

The proposed device, U80 Series Electronic Blood Pressure Monitor, is a battery driven automatic on-invasive blood pressure monitor. It can automatically complete the inflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult person at upper arm within its claimed range and accuracy via the oscillometric technique. User can select the unit of the measurement: mmHg or kPa. All the models included in this submission follow the same measurement principle and same specifications. The main differences are appearance, data storage and time display. These three differences will not affect the safety and effectiveness of the device.