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The Welch Allyn ProBP 2000 Digital blood pressure device is intended for use in measuring blood pressure and heart rate in patients at least 3 years of age or older with arm circumferences between 15 cm to 55 cm (approximately 5.9 to 21.7 inches). The Welch Allyn ProBP 2000 automatically measures systolic and diastolic pressure and pulse rate. The device is intended to be used by clinicians and medically qualified personnel. Contraindications: This device is not intended for use on neonates, infants, or children under the age of 3 years. The effectiveness of this device has not been established in pregnant, including pre-eclamptic, patients.

The device is designed to measure the systolic and diastolic blood pressure and heartbeat rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the arm. This device is designed for professional use, in other words, it is a professional BP device that only for trained users such as nurses, clinicians, and medically qualified personnel. The measurement method for determining the systolic and diastolic pressure is similar with the ausculatory 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 heartbeat rate. This well-known technique for measuring blood pressure is called the "Oscillometric method". The device includes the main unit and cuff unit. The main unit consists of the microprocessor, the pressure sensor, the operation key, the pump, the electromagnetic deflation control valve and the LCD. ABS is the plastic used in the outer housing. The device comes with one standard Reusable-11 Welch Allyn FlexiPort cuff. Other size cuffs can be ordered as needed for arm circumferences ranging from 15cm to 55cm. This device is equipped with the same wireless radio (Bluetooth) as supplied with the predicate device cleared in K161886, TMB-1591-A. The subject device does not incorporate any software to support the BT wirelessly transmit function. In other word, ProBP 2000 has BT module but disabled the Bluetooth functionality. And Welch Allyn does not provide an application to receive data utilizing BT The subject device does not have any externally-facing electronic interfaces.