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The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population with wrist circumference ranging from 6.3 inches (16.0cm to 19.0cm). The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.

The Omron HEM-6410T-ZM Wrist Blood Pressure Monitor ("HEM-6410T-ZM") is a battery-powered automatic non-invasive blood pressure system intended for home use. HEM-6410T-ZM is intended for use in adult patient population with wrist circumference ranging from 6.3 inches to 7.5 inches (16.0cm to 19.0cm). The device is powered by a rechargeable lithium-polymer battery. An AC adapter is used for charging the device. but the device cannot be operated while charging. The device wrist cuff inflates using an integral pump, and deflates via an electric valve. During inflation, the wrist cuff pressure is monitored and pulse waveform data is extracted. The extracted pulse waveform data is then analyzed by software which determines pulse rate, as well as systolic and diastolic blood pressure. The systolic and diastolic blood pressures are measured using the oscillometric method. The cuff can measure pressure range from 0 to 299mmHz, and the pulse rate range from 40 to 180 beats/min.

The blood pressure reading is displayed in "red" color if the blood pressure recorded is equal to or greater than 130/80 based on the American Heart Association (AHA)/ American College of Cardiology (ACC) High Blood Pressure Clinical Practice Guideline criterion for Stage 1 Hypertension, published in 2017. The device displays the latest blood pressure reading, while up to 100 readings can be stored in memory. The device also detects the appearance of irregular heartbeats during the blood pressure measurement process. An irregular rhythm is defined as the appearance of two (2) or more heartbeat intervals which differ by greater than 25% from the average heartbeat rhythm. Detection of such irregular rhythms would result in an "irregular heartbeat symbol" displayed along with the blood pressure and pulse rate readings.

In addition, the device includes an Advanced Positioning Sensor (APS), known as the Heart Zone Indicator, which aids the user to determine if the wrist cuff is at the correct height in relation to the heart. This determination is based on the reading of an accelerometer (integral to the device) to measure the angle of the arm. The APS feature is similar to that of the predicate device. The operation of the device is intended for home use. Additional functions and other features that are controlled by the end user include applying the wrist cuff to the wrist, powering on/off the system, starting or stopping the blood pressure (BP) and pulse measurement cycle, and charging the battery as needed. As an optional feature, the user can also pair the HEM-6410T-ZM to a smartphone when employing the "Omron connect" app. This app is an optional feature and is only intended to display trend graphs of measured systolic and diastolic blood pressure, and pulse rate. This app does not provide any diagnostic or measurement functions, and does not interpret or analyze the data for medical decision making. Unlimited readings can be stored in the app for archiving and review by the user. Aside from this optional app for smartphones, HEM-6410T-ZM does not connect with other collateral devices.

The provided text describes the OMRON HEM-6410T-ZM Wrist Blood Pressure Monitor and outlines its acceptance criteria and the study conducted to prove it meets them for FDA

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