Mark Of Fitness MF 46 warranty Basic Product Information, Specifications

BASIC PRODUCT INFORMATION

This manual is intended to assist the user in the safe and efficient operation of the Model MF-46 Digital Blood Pressure Monitor. The product must be used in accordance with the procedures contained in this manual and must not be used for purposes other than those described herein. It is important to read and understand the entire manual. In particular, please read carefully and become familiar with the section entitled “TIPS ON TAKING YOUR BLOOD PRESSURE”.

The user is cautioned that the system may fail to yield specified measurement accuracy if operated or stored in temperature or humidity conditions outside the limits stated in the specifications section of this manual. Also, an inaccurate reading may result if this instrument is used on a child's arm. Consult your physician if you wish to take a child's blood pressure.

Indications for Use

The MF-46 system is intended for the non-invasive measurement of systolic and diastolic blood pressure and determination of heart rate in adult patients, i.e., age 15 and above. The product is recommended for use by patients with labile blood pressure or known hypertension in a home care environment as an adjunct to medical management. The cuff will accommodate an upper arm circumference range of approximately 8.7 to 12.6 inches (22 to 32 centimeters). Pressure is measured over a range of 0 to 300 mmHg and heart rate over a range of 40 to 160 beats/minute.

Method of Measurement

This product employs the oscillometric method for measurement of blood pressure and heart rate. The cuff is connected to the main unit and wrapped around the arm. Circuits within the monitor sense the small oscillations in

pressure against the cuff produced by the expansion and contraction of the arteries in the arm in response to each heart beat. The amplitude of each pressure wave is measured, converted to millimeters of mercury, and displayed on the LCD as a digital value. Memory circuit stores the 30 most recent measurement results for comparison.

Accuracy was evaluated during clinical studies in which results with the MF- 46 system were compared with simultaneous auscultatory measurements obtained with a standard sphygmomanometer. In these studies, the onset of the fourth (or fifth) Korotkoff sound was taken as the diastolic pressure for the purpose of determining overall efficacy. A copy of this study is available from the manufacturer on request. To insure that accuracy is maintained, compare readings obtained with the MF-46 system with values measured by a trained observer using a manual sphygmomanometer at least every 6 months.

Blood pressure measurements determined with this device are equivalent to those obtained by a trained observer using the cuff stethoscope auscultation method, within the limits prescribed by the American National Standard, Electronic or Automated Sphygmomanometers.

The MF-46 system has the ability to function according to its specifications in the presence of common arrhythmias such as atrial or ventricular premature beats or atrial fibrillation.

CAUTION!

Do not use cuffs other than the original cuff included with this product.

SPECIFICATIONS

Model	: MF-46	Power Consumption	: 4W (max.)
Operating Principle	: Oscillometric method	Memory	: 30 measurement results x 2, computation
Indicator	: 13 digits LCD display		of the average of stored Data
Pressure indicating Range : 0 to 300 mmHg (Cuff pressure)		Operating environment	: +50˚F to+104˚F, 15 to 90% relative humidity
Measuring Range	: 50 to 250 mmHg (systolic)	Storage environment	: -4˚F to+122˚F, 15 to 95% relative humidity
	40 to 180 mmHg (diastolic)	Cuff	: Coverage arm circumference ; 8.7 to 12.6 in.
	40 to 160 pulse/min. (pulse rate)		[22 to 32 cm]
Accuracy	: ±3 mmHg (Cuff pressure)	Main Unit	: Weight ; Approx. 13.4 oz. [370 g] (without
	±5% of reading (pulse rate)		batteries)
Inflation	: Automatic inflation		Size ; 6.4 x 7 x 3.2 in [163 x 180 x 83 mm]
			(W x D x H) when CUFF HOLDER attached
Deflation	: Electric control valve
Exhaust	: Automatic exhaust valve
Power Supply	: 4 pcs. 1.5 volt "AA" (R6P/LR6) type batteries	Specifications are subject to change without notice due to improvements
	or AC adapter	in performance.

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