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Cautions
When an adult patient is monitored, the device may fail in giving the blood pressure
measurement if the pediatric patient type is selected.
Before use of the cuff, empty the cuff until there is no residual air inside it to ensure
accurate measurement.
Do not twist the air tube or put heavy things on it. This may cause inaccurate blood
pressure values.
When unplugging the air tube, hold the head of the connector and pull it out.
The NIBP measurement is affected when the monitor is connected to the patient on whom
the electro-surgical unit and defibrillator are used.
The appearance of arrhythmia in an irregular heartbeat may affect the accuracy of NIBP
measurement. It is recommended to retake the measurement in this case.
The blood pressure measurements determined with this device are equivalent to those
obtained by a trained observer using the cuff/stethoscope auscultatory method, within the
limits prescribed by the American National Standard, manual, electronic, or automated
sphygmomanometers.
The monitor can be used on the patients who are pregnant or pre-eclamptic, but close
attention should be paid to such patients.
The performance of the NIBP function can be affected by the extremes of temperature,
humidity, and altitude; please use it within the appropriate working environment.
Do not apply the cuff and its pressure on the arm at the side of mastectomy or lymph node
clearance.
The cuff pressure may temporarily cause loss of function of simultaneously used
monitoring medical device on the same limb.
The NIBP module of the device was clinically investigated according to the requirements
of ISO 81060-2:2013.
9.3 Measurement Limitations
Serious angiospasm, vasoconstriction, or too weak pulse limit measurement accuracy.
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Measurements are inaccurate when extremely low or high heart rate or severe arrhythmia of the
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patient occurs. Auricular fibrillation leads to unreliable or impossible measurements.
Do not take the measurement when the patient is connected with an artificial heart-lung machine.
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Do not take the measurement when the patient uses diuresis or vasodilator.
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When the patient is suffering from significant hemorrhage, hypovolemic shock, and other
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conditions with rapid blood pressure change or when the patient has too low body temperature,
the reading will not be reliable. Reduced peripheral blood flow leads to reduced arterial pulsation.
Measurements are not accurate on a patient with hyperadiposis.
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