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Philips Expression MR400 Instructions For Use Manual Page 394

Mri patient monitoring system.
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Notes
The effectiveness of NIBP has not been established in the presence of any dysrhythmias included in the exclusion
criteria.
The NIBP clinical study was performed on adult and pediatric patients with the following attributes:
– The effectiveness of NIBP has not been established in the presence of any dysrhythmias included in the
exclusion criteria.Gender: 61% male, 39% female.
– No patients less than 29 days of age.
– Patients with limb circumferences ranged from 10.5 cm to 39 cm, with a distribution of 46 percent below
25 cm and 7 percent above 35 cm.
– The arterial systolic pressure ranges from 58 mmHg to 211 mmHg, with an average of 115 mmHg and with
a distribution of 32.7 percent below 100 mmHg and 2.4 percent above 180 mmHg. The arterial diastolic
pressure ranges from 34 mmHg to 131 mmHg, with an average of 65 mmHg and with a distribution of 42.3
percent below 60 mmHg and 3.9 percent above 100 mmHg.
– Patients with any sign of arterial disease were excluded.
– Patients with a heart beat greater than 180 BPM were excluded.
– The radial artery was acceptable as a reference site for all patients but one which used the femoral artery.
– The effectiveness was not validated on pregnant, including pre-eclamptic, patient populations.
The NIBP clinical study was performed on neonatal patients with the following attributes:
– No specified gender.
– All patients 28 days or less if born at term (37 gestation or more); otherwise, up to 44 gestational weeks.
– Patients with limb circumferences ranged from 5.75 cm to 13 cm with an average of 7.9 cm.
– The arterial systolic pressure ranged from 42 mmHg to 89 mmHg, with an average of 57 mmHg. The
arterial diastolic pressure ranged from 20 mmHg to 62 mmHg, with an average of 34 mmHg.
Arterial reference sites included the umbilical, femoral, brachial and radial artery.
A‐26   Specifications   
Non-Invasive Blood Pressure
Expression MR400 Instructions for Use

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