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The BPro system is intended for use on patients who are eighteen (18) years and older and who have a palpable radial pulse. The BPro system is intended only for measurement, recording, and display. It makes no diagnosis.

HealthSTATS BPro® Ambulatory Blood Pressure Monitoring System with BProSOft CASP® PC software is a noninvasive ambulatory blood pressure monitoring system based on arterial tonometry at the radial artery of the wrist. The system consists of three main elements: . BPro wrist-mounted tonometric monitor (listed device K060315), . BProSoft CASP report management software, a PC-based computer program (new/added measurement function). . BPCalibrator MC3000 oscillometric blood pressure monitor [listed device, K051546] for calibration of BPro monitors. Once the BPro is calibrated using the BPcalibrator oscillometric device, it is capable of measuring and recording systolic pressure, diastolic pressure and pulse rate over a period of 24 hours. Arterial pulse waveforms obtained over the 24 hour period are used by the BProSoft CASP PC software to calculate central aortic systolic pressure (CASP).

The A-PULSE CASPal+ and MC3100+ Monitors are intended for use on patients who are eighteen (18) years and older, and for the CASPal+, have a palpable radial pulse. Brachial Blood pressure, CASP and pulse rate readings obtained using the A-PULSE CASPal+ and MC3100+ Monitors are intended for use by qualified healthcare personnel as an aid to diagnosis and treatment.

The HealthSTATS A-PULSE CASPal® and MC3100™ are standalone noninvasive blood pressure monitors which are designed to measure (1) conventional oscillometric blood pressure with a brachial cuff and (2) Central Aortic Systolic Pressure (CASP) and other indices based on arterial tonometry at the radial artery of the wrist. The CASPal®+ Monitor is comprised of four main elements: - System embedded processing unit. - Integrated oscillometric blood pressure module for calibration (identical to the BPCalibrator [listed device K041546], also cleared iin CASPal device K101002). - Wrist sensor module for acquistion of central aortic systolic pressure (CASP) via radial arterial tonometry at the wrist [cleared accessory and method K101002]. - Bluetooth® wireless communications module. The MC3100™* is a reduced feature set of the CASPal®* which only offers the oscillometric blood pressure measurement and not the CASP measurement, but is otherwise identical. my-BP™ PC software may be used with either device to store and display blood pressure and pulse rate measurements on a suitably equipped computer.

The A-PULSE CASPro/CASPal Monitors are intended to measure systolic and diastolic blood pressure and pulse rate, and to utilize the radial pulse waveform to derive central aortic systolic pressure (CASP) and other waveform indices. Cardiovascular disease remains among the leading causes of death worldwide. Hypertension assessment is one of the primary factors in the evaluation of cardiovascular disease. Assessment of CASP may improve the stratification and management of patients with elevated cardiovascular risk. The A-PULSE CASPro/CASPal Monitors are compact standalone monitors that combine two methods of blood pressure measurement: - Conventional oscillometric blood pressure via a brachial cuff on the upper arm, and - Radial arterial pulse acquisition via a wrist-mounted tonometer sensor. The A-PULSE CASPro/CASPal Monitors first measure systolic and diastolic blood pressure and pulse rate via the oscillometric method, and then acquire the radial arterial pulse waveform to derive the Central Aortic Systolic Pressure (CASP) non-invasively. The A-PULSE CASPro monitor has a graphical display that displays the arterial pulse waveform as well as a range of other pulse indices. The A-PULSE CASPal monitor has a numeric display. Both models have a nonvolatile memory to store and recall measurements. Brachial Blood pressure, CASP and pulse rate readings obtained using the A-PULSE CASPro/CASPal Monitors are intended for use by qualified healthcare personnel as an aid to diagnosis and treatment. The A-PULSE CASPro/CASPal Monitors are intended for use on patients who are eighteen (18) years and older and who have a palpable radial pulse. Caution: Federal law (U.S.A.) restricts this device to sale by or on the order of a physician or other licensed practitioner.

HealthSTATS A-PULSE CASPro/CASPal Monitors are standalone noninvasive blood pressure monitors which are designed to measure (1) conventional oscillometric blood pressure with a brachial cuff and (2) Central Aortic Systolic Pressure (CASP) and other indices based on arterial tonometry at the radial artery of the wrist. The CASPro/CASPal Monitors are comprised of four main elements: - Integrated oscillometric blood pressure module for calibration . (identical to the BPCalibrator [listed device K041546]). - . Wrist sensor module based on the technology of the BPro® monitor device [listed device K060315]. - Software algorithm for radial arterial blood pressure measurement . and calculation of CASP based on the A-PULSE PC Software [listed device K072593]. - A-PULSE CASPro®, A-PULSE CASPal® main processing unit. . Two functionally equivalent monitors are offered in this 510(k), the A-PULSE CASPro Monitor and the A-PULSE CASPal Monitor: - . The CASPro Monitor device is equipped with a full featured color TFT LCD panel to display blood pressure readings and radial arterial pulse waveforms. The device also has a real time calendar clock for time-stamped stored readings. - The A-PULSE CASPal Monitor device is equipped with a simplified . monochrome LCD panel to provide numeric blood pressure readings and a pulse bar to display radial arterial pulsations. The operation sequence of both A-PULSE CASPro and CASPal Monitors is the same and both devices use identical hardware and software alqorithms to measure and report conventional systolic and diastolic blood pressure readings (BP), Central Aortic Systolic Pressure (CASP), and pulse rate (PR).

The A-Pulse™ Arterial Pulse Waveform Analysis System consists of A-Pulse PC Software, the BPro® Blood Pressure monitor, and the BPCalibrator Oscillometric monitor. A-Pulse PC software is used in conjunction with the HealthSTATS BPro Blood Pressure monitor to provide data to qualified medical personnel for the purpose of assessing the patient's cardiac health via blood pressure waveforms measured at the radial artery. Before each measurement session, the BPro wrist-mounted tonometric device is calibrated using the BPCalibrator oscillometric monitor. Once calibrated, A-Pulse PC Software is capable of acquiring and displaying arterial blood pressure waveforms from the BPro wrist device. A-Pulse PC software is intended to measure systolic and diastolic blood pressure and pulse rate, and to utilize the radial pulse waveform to derive central aortic pressure (CAP), radial augmentation index (rAl), and a range of other indices. A-Pulse PC Software is intended for use on patients who are eighteen (18) years and older and who have a palpable radial pulse.

HealthSTATS BPro® is a noninvasive arterial waveform analysis system system based on arterial tonometry at the radial artery of the wrist. The system consists of three main elements: - A-Pulse PC Software for radial arterial pulse waveform analysis, a PC-. based computer program [new device]. - BPro® wrist-mounted tonometric monitor [listed device K060315]. . - BPCalibrator MC3000 oscillometric blood pressure monitor [listed . device, K051546] for calibration of the BPro monitor .. Once calibrated using the BPCalibrator oscillometric device, A-Pulse PC Software is capable of acquiring and displaying arterial blood pressure waveforms from the BPro wrist device. The BPro monitor is applied to the wrist with a pressure transducer placed over the radial artery. The monitor has a size and weight similar to a sports type wrist watch. An embedded microcontroller supervises the actions of the monitor including scheduled measurements, on-demand measurements, and serial data communication with the host PC. The A-Pulse PC Software measures arterial waveforms in real time, calculates blood pressure parameters and indices on selected waveforms. and stores and prints reports.

The BPro system is intended for use on patients who are eighteen (18) years and older and who have a palpable radial pulse. The BPro system is intended only for measurement, recording, and display. It makes no diagnosis.

HealthSTATS BPro® is a noninvasive ambulatory blood pressure monitoring system based on arterial tonometry at the radial artery of the wrist. The system consists of three main elements: - BPro/BPal wrist-mounted tonometric monitor. - BProSoft report management software, a PC-based computer program. - BPCalibrator MC3000 oscillometric blood pressure monitor [listed . device, K051546] for calibration of BPro/BPal monitors. Once the BPro is calibrated using the BPcalibrator oscillometric device, it is capable of measuring and recording systolic pressure, diastolic pressure and pulse rate over a period of 24 hours.

The BPCalibrator™ MC3000/MC3100 is an oscillometric blood pressure monitor for measuring systolic pressure, diastolic pressure and pulse rate. The device is intended for use at home or in doctor's office settings on patients who are eighteen (18) years and older and who do not have common arrhythmias, such as atrial or ventricular premature beats or atrial fibrillation. The arm circumference range shall be between 8.3 inches (21 cm) and 16.5 inches (42 cm). The BPCalibrator™ MC3000 has a communication port that enables blood pressure and pulse rate readings to be transmitted to other electronic devices designed to communicate with it. Blood pressure and pulse rate readings obtained using the device are intended for use by qualified healthcare personnel as an aid to diagnosis and treatment.

The BPCalibrator™ MC3000/MC3100 is an oscillometric blood pressure monitor for measuring systolic pressure, diastolic pressure and pulse rate at home or in clinical settings. A cuff is applied to the upper arm before measurement. When a measurement is initiated, the cuff is inflated to a pressure higher than the systolic pressure and then deflated. Pressure pulses measured from the cuff during deflation are used to calculate blood pressure and pulse rate using the oscillometric method.