Search Results

Arm-type Fully Automatic Digital Blood Pressure Monitors(Model: DBP-62F4L, DBP-62F4B, DBP-61F4, DBP-61F4L, DBP-61D2L, DBP-63D2L, DBP-61D9L, DBP-63D9L) are intended to measure blood pressure (systolic and diastolic) and pulse rate of adults and adolescents over 12 years of age with circumference ranging from 22cm to 42cm.

Arm-Type Fully Automatic Digital Blood Pressure Monitor( Model: DBP-61D2L-P, DBP-63D2L-P, DBP-61D9L-P, DBP-63D9L-P, DBP-61F4-P, DBP-61F4L-P, DBP-62F4L-P, DBP-62F4B-P)are intended to measure blood pressure (systolic and diastolic) and pulse rate of adults and adolescents over 12 years of age with circumference ranging from 22cm to 42cm. The device is also indicated in pregnant women with normotension, gestational hypertension, or preeclampsia with circumference ranging from 22cm to 42cm.

Arm-Type Fully Automatic Digital Blood Pressure Monitor( Model: DBP-61D2L, DBP-63D2L, DBP-61D9L, DBP-63D9L, DBP-62F4L, DBP-62F4B, DBP-61F4, DBP-61F4L,) are intended to measure blood pressure (systolic and diastolic) and pulse rate of adults and adolescents over 12 years of age with circumference ranging from 22cm to 42cm.

Arm-Type Fully Automatic Digital Blood Pressure Monitor( Model:DBP-61D2L-P,DBP-63D2L-P, DBP-61D9L-P, DBP-63D9L-P, DBP-61F4-P, DBP-61F4L-P, DBP-62F4L-P, DBP-62F4B-P)are intended to measure blood pressure (systolic and diastolic) and pulse rate of adults and adolescents over 12 years of age with circumference ranging from 22cm to 42cm. The device is also indicated in pregnant women with normotension, gestational hypertension, or preeclampsia with circumference ranging from 22cm to 42cm.

They are automatic, non-invasive, blood pressure measurement system for over-the-counter (OTC) use at home and clinical environment. The systolic and diastolic pressures are determined using the oscillometric method, where the cuff is inflated with an integral controllable piezoelectric pump and deflates via an electric automatic rapid deflation valve. During inflation measurements, an electric pump within the main unit slowly inflates the arm cuff, generating cuff pressure which is monitored and from which pulse waveform data is extracted. This waveform data is analyzed by software algorithms within the microprocessor to determine pulse rate, systolic pressure, and diastolic pressure. The cuff can measure pressure range from 0 to 299mmHg, and the pulse rate range from 30 to 180 beats/min. The pulse rate measurement is compare the longest and the shortest time intervals of detected pulse waves to mean time interval and displays a warning signal with the reading to indicate the detection of irregular heartbeat when the difference of the time intervals is over 25%.The devices are not intended to detect atrial fibrillation or any other arrhythmias. The Irregular heartbeat indicator is solely intended as a technical error/indicator. Irregular heartbeat rhythm is defined as rhythm that is either 25% slower or faster than the average rhythm detected while measuring systolic blood pressure and diastolic blood pressure.

DBP-62F4L, DBP-62F4B, DBP-62F4L-P, DBP-62F4B-P with bluetooth function can be used as a stand-alone unit to finish the blood pressure measurement or in conjunction with the APP through embed a 2.4GHz BLE module that allow users to connect with nearby BT receiving terminal. Once measurement is over, the LCD display of the device appears results. And the device will start to transmit data to the pair-up terminal automatically.

DBP-63D2L, BP-63D9L, DBP-63D2L-P, DBP-63D9L-P with additional WiFi function can also allow users better receive measurement result on mobile phone.

With the use of software (including APP) and wireless communication module, the wireless software function and hardware function are solely intended to transfer, store, convert formats, or display medical device data and results (blood pressure and pulse rate readings), without controlling or altering the functions or parameters of any connected medical devices, which is not be intended for active patient monitoring, therefore, based on the FDA guidance titled 'Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices' (issued on September 28, 2022.), this software function is belong to Non-device-MDDS, and the hardware function is belong to Device-MDDS, they are not subject to FDA laws and regulations applicable to devices.

N/A

Ask a specific question about this device