B40 Non-Invasive Blood Pressure Equivalency Study

Not Applicable

Completed

Brief Summary: The purpose of this study is to demonstrate equivalency of the GE Healthcare B40 Patient Monitor noninvasive blood pressure (NIBP) parameter compared to the reference device.

Detailed Description: Automated non-invasive blood pressure devices have a long history. These devices first made their appearance in the mid-1970's. Since that time, there have been many improvements in the performance of these devices. Specifically, when making changes to the algorithms that control these devices, the goals are: to improve accuracy and precision in the blood pressure (BP) estimates, to reduce the time needed to determine the BP estimates, to increase comfort for the patient, and to work through artifacts and arrhythmias that are often present in the clinical environment.

The purpose of this study is to demonstrate equivalency of the GE Healthcare B40 Patient Monitor noninvasive blood pressure (NIBP) parameter compared to the reference device.

Recruitment & Eligibility

Inclusion Criteria

Ability to provide written informed consent or have a legally authorized representative including a parent or guardian provide written informed consent
Within the age range from older than 3 years old to 75 years old (adult and child)
Ability to maintain proper placement of cuff and/or probe and/or sensor

Exclusion Criteria

Neonates (ages 0-29 days) and infants (30 days to 3 years old) shall be excluded
Any subject deemed too unstable, by clinician's discretion, or for another reason deemed unacceptable for study by the clinician
Known dysrhythmias (when applicable)
Known disease state that compromises circulation to the extremity
Vigorous exercise prior to participating in the study
Excessive movement or excitability causing false values or no determinations
Known allergy to latex when latex products will be in contact with subject
Pregnant females

Arm && Interventions

Group	Intervention	Description
Blood Pressure Reading	Blood Pressure Readings on B40 Patient Monitor	Simultaneous blood pressure readings with DINAMAP PRO1000 and B40 monitor; total of 6 successful readings

Primary Outcome Measures

Name	Time	Method
Difference Between the B40 Monitor and Reference Device DINAMAP PRO1000 on NIBP Measurements	End of each blood pressure reading	The primary endpoints are the difference in systolic, diastolic and mean blood pressure values between the B40 Monitor and PRO1000. The mean of the difference should be no more than 5mmHg and the standard deviation of the difference should be no more than 8mmHg per the AAMI SP-10 standard.

Secondary Outcome Measures