EDAN F9 User Manual page 139

F9 and F9 Express Fetal & Maternal Monitor User Manual
and pulse rate (PR) (optional) are measured and displayed.
The blood pressure measurements determined with this device comply with the American
National Standard for Electronic or Automated Sphygmomanometers (ANSI/AAMI/ISO
81060-2:2013) in relation to mean error and standard deviation.
In clinical investigation method with a reference sphygmomanometer, the fifth Korotkoff sound
was used to determine adult diastolic pressure, and the fourth Korotkoff sound was used to
determine pediatric diastolic pressure.
1 Check for any fault of the cuff before start monitoring.
2 Do not perform NIBP measurements on patients with sickle-cell disease or under any
condition where the skin is damaged or expected to be damaged, such as on the arm
on the side of a mastectomy.
3 Pressurization of the cuff can temporarily cause loss of function of simultaneously
used monitor on the same limb.
4 If liquid is splashed on or into the main unit inadvertently, or enters the conduit, stop
using the monitor and contact the manufacturer for service immediately.
5 For a thrombasthemia patient, it is important to determine whether the measurement
of blood pressure shall be done automatically. The determination should be based on
clinical evaluation.
6 Do not apply the cuff to a limb that has an intravenous infusion or catheter in place
frequently. This could cause tissue damage around the catheter when infusion is
slowed or blocked during cuff inflation.
7 Make sure that the air conduit connecting the blood pressure cuff and the monitor is
neither blocked nor tangled.
NOTE:
The monitor is intended to measure NIBP for adults only.
Measurement Limitations -
To different patient conditions, the oscillometric measurement has certain limitations. The
measurement is in search of regular arterial pressure pulse. In those circumstances where the
patient's condition makes it difficult to detect, the measurement becomes unreliable and the
measuring time increases. You should be aware that the following conditions could interfere
with the measurement, making the measurement unreliable or longer to derive. In some cases,
the patient's condition will make a measurement impossible.
1) Patient Movement
Measurements will be unreliable or may not be possible if the patient is moving, shivering or
having convulsions. These motions may interfere with the detection of the arterial pressure
pulses. In addition, the measurement time will be prolonged.
WARNING
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Maternal Monitoring