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