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The ABPM 7100 is an automated, microprocessor controlled ambulatory blood pressure monitor (ABPM) which records, accumulates and stores: heart beat (rate), systolic and diastolic data of an individual patient (in the patient's environment) for a session which may last 24 hours. Ambulatory monitoring is not supported for the 14-20 cm cuff size. It is used with a standard upper-arm cuff for blood pressure measurement. The ABPM 7100 in combination with the Hypertension Management Software (HMS) provides a derived ascending aortic blood pressure wave form and a range of central indices. It is used in those adult patients, where information related to the ascending aortic blood pressure is desired, but in the physician, the risk of cardiac catheterization procedure or other invasive monitoring may outweigh the benefits.

The ABPM 7100 applies the oscillometric principle for blood pressure measurements. The ABPM 7100 consists of the following hardware: - the ABPM 7100 recorder - - the brachial blood pressure cuff - The ABPM 7100 is available with five different cuff sizes to adapt to the patient's arm size. Initially, the device is prepared for a new patient and measurements are started. Measurement data is recorded and stored in the device's memory. The data can then be transmitted to a computer in the physician's office via Bluetooth or cable for storage, presentation and analysis. Central Blood Pressure (CBP) calculation is realized through Pulse Wave Analysis, conducted by the Hypertension Management Software with CBP Upgrade.

The ABPM 7100 is an automated microprocessor controlled ambulatory blood pressure monitor (ABPM) which monitors, accumulates and stores: heart beat (rate), systolic and diastolic data of an individual adult patient (in the patient's environment) for a session which may last 24 hours. The ABPM 7100 in combination with Hypertension Management Software Client Server (HMS-CS) provides a derived ascending aortic blood pressure waveform and a range of central arterial indices. Use of the Augmentation Index AIx only is restricted to patients of age 40 and above. It is used with a standard cuff blood pressure measurement. It is used in those patients where information related to the ascending aortic blood pressure is desired but in the opinion of the physician, the risk of cardiac catheterization procedure or other invasive monitoring may outweigh the benefits.

The ABPM 7100 consist of the following hardware: - the ABPM 7100 monitor - the brachial blood pressure cuff - The ABPM 7100 is available with three different cuff sizes (S, M, L, XL) to adapt to the patient's arm size. Patient data is stored in the device's memory. The data can then be transmitted to a computer in the physician's office via Bluetooth and Cable. The recordings are displayed for the evaluation by the health professional by the application of the Hypertension Management Software Client Server ("HMS CS"). The ABPM 7100 is used together with the application software the Hypertension Management Software Client Server (HMS-CS 4.7-US) as a system.

The Mobil-O-Graph 24h PWA system featuring PWA is an automated microprocessor controlled ambulatory blood pressure monitor (ABPM) which monitors, accumulates and stores: heart beat (rate), systolic and diastolic data of an individual adult patient's environment) for a session which may last 24 hours. The Mobil-O-Graph 24h PWA in combination with Hypertension Management Software Client Server (HMS-CS) provides a derived ascending aortic blood pressure waveform and a range of central arterial indices. Use of the Augmentation Index Alx only is restricted to patients of age 40 and above. It is used with a standard cuff blood pressure measurement. It is used in those patients where information related to the ascending aortic blood pressure is desired but in the opinion of the physician, the risk of cardiac catheterization procedure or other invasive monitoring may outweigh the benefits.

The Mobil-O-Graph 24h PWA is a modified version of the Mobil-O-Graph New Generation (K072446). Hardware, general design and housing are very similar, being different in minor items such as artwork /labeling, etc. Full blood pressure measurement technology, hardware including electrical components, sensors, safety circuits and the cuff are identical to the cleared device. The internal device software (=firmware) algorithms for blood pressure measurement are identical. Minor additions have been made to allow for execution of PWA-measurements. Internal memory has been extended to collect the additional data generated during PWA measurement. Like the predicate Mobil-O-Graph New Generation (K072446), the new device Mobil-O-Graph 24h PWA is used together with the Hypertension Management Software Client-Server (HMS-CS). Full functionality and technology for read-out, storage, evaluation and display of data related to ambulatory blood pressure monitoring (ABPM) is therefore substantially equivalent. Like the predicate device SphygmoCor CvMS (K070795), consisting of data acquisition hardware and associated computer software, the Mobil-O-Graph 24h PWA together with its analysis software Hypertension Management Software Client-Server (HMS-CS) is a computerized tool for the assessment of a range of central indices. The Mobil-O-Graph 24h PWA system featuring PWA measures peripheral (brachial) blood pressure and records the peripheral pulse wave. The software HMS-CS utilizes a general transfer function (GTF) to derive an ascending aortic pulse wave from the readings. Measurements and the pulse wave are used to calculate a range of central arterial indices. The Mobil-O-Graph 24h PWA is used with a standard brachial blood pressure cuff measurement, like the predicate Mobil-O-Graph New Generation. The Mobil-O-Graph 24h PWA is intended for use on those patients where information related to ascending aortic blood pressure is desired. In addition, the Mobil-O-Graph 24h PWA incorporates an option to enable users to carry out and store Pulse Wave Analysis (PWA) over 24 hours, in parallel to regular 24h ambulatory blood pressure measurement. The Mobil-O-Graph 24h PWA is made up of two primary system components: 1) a modified reqular ABPM Mobil-O-Graph New Generation (K072446); 2) proprietary software HMS-CS, current version V4.3. Full data acquisition and storage of measurements for both ABPM and PWA is realized by the Mobil-O-Graph 24h PWA device itself, without any use of the HMS-CS software. Analysis of raw data and calculation of PWA-related parameters is realized through the HMS-CS software. To calculate and display the PWA results, the Mobil-O-Graph 24h PWA must be coupled via Bluetooth to a physician's computer that is currently running HMS-CS Software. For PWA measurements, there are two modes, 1 and 2. Mode 1 is called "practice monitoring". where the patient is at the physician's office and has both blood pressure and PWA measurements started manually. Data transfer is directly after completion of the measurement, via Bluetooth wireless technology. PWA parameters are calculated right away, so the physician can evaluate the result while seeing the patient. Mode 2 is called "24h PWA", where the patient leaves the office and the device takes both measurements in automated mode, over a period of 24 hours. Upon return of the patient (and the device) to the physician, data is transferred completely to the physician's PC for later evaluation. The Mobil-O-Graph 24h PWA system is available with three different cuff sizes (M, L, XL) based on patient's arm size. All measurements may be stored and viewed on a computer which is connected to the Mobil-O-Graph 24h PWA via a standard Bluetooth connection. Patient data can be printed using a reqular installed office printer, preferably with color capability. The device does not generate any real-time alarms. It does not provide diagnosis. Clinical judgment and experience are required to evaluate and interpret the information provided.

The Mobil-O-Graph ABPM system is an automated, microprocessor controlled blood pressure monitor which monitors, accumulates and stores: heart beat (rate), systolic and diastolic data of an individual adult patient (in the patient's environment) for a session which may last 24 to 48 hours.

The Mobil-O-Graph NG ABPM (24 hour Automatic Blood Pressure Monitor) is a fully automatic table model device that measures blood pressure by means of an inflatable cuff on the upper arm. It employs the Oscillometric Principle.

The Stabil-O-Graph Blood Pressure Monitor is intended to be used by adults at home to measure blood pressure (systolic and diastolic) and pulse rate from the upper arm. The I.E.M. Stabil-O-Graph is intended to be used by adults at home to monitor Blood Pressure (systolic and diastolic) and pulse rate from the upper arm with arm circumference ranging from 9.4 inches to 16.5 inches (24 cm to 42 cm).

The Stabil-O-Graph Blood Pressure Monitor is a fully automatic table model device that measures blood pressure in a human being by means of an inflatable cuff on the upper arm. It employs the method of the "Oscillometric Principle".