Evaluation Of The GE Monitor Product Line

Study Overview
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Brief Summary
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This investigation is a multi-center study that will demonstrate that the GE Monitor meets equivalency and/or accuracy and/or performance criteria. This investigation will compare the test device(s) to itself, or one of the reference parameters, or a combination of parameters, including NIBP, temperature, SpO2, respirations, and ECG.

Official Title
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Evaluation Of The GE Monitor Product Line

Conditions
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Non-invasive Blood Pressure, Temperature, SpO2, Respiration, ECG

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent from subject and/or guardian Ability to maintain proper placement of cuff and/or probe and/or sensor Presence of atrial fibrillation or other irregular heart rhythm (when applicable) Ability to single or dual monitor NIBP, ECG, and/or SpO2, whether or not already being monitored for any or all of these parameters (SuperSTAT development study only) Exclusion Criteria: 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 or medical condition that A) compromises circulation to the extremity, B) compromises musculo-skeletal integrity, or C) otherwise contraindicates use of a NIBP cuff and/or SpO2 sensor on an extremity or ECG patches on skin 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 Subjects who have eaten, drank, smoked or chewed gum in the preceding half hour (temperature parameter only) Nasal/septal defects, cold and/or allergies that would not allow the subject to breathe through their nose (temperature parameter only) Subjects with whom flammable anesthetics will be used. Adult/pediatric subjects,(greater than 1 year of age) who, at the clinician's discretion, could not tolerate approximately 12, but no more than 25 blood pressures on each extremity Pediatric/neonatal subjects,(less than 1 year of age) who, at the clinician's discretion, could not tolerate approximately 10, but no more than 12 blood pressures on each extremity Presence of pacemaker which makes the atrial fibrillation rhythm indistinguishable Subject's limb circumference is outside of the manufacturer's recommended cuff range Subject has Korotkoff sounds that persist to nearly zero (when applicable)

Ages Eligible for Study
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Minimum Age: 1 Minute

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Neonates<br>Subjects ages birth to 30 days | |
| Infants<br>Subjects aged >30 days to 2 years | |
| Adults<br>Subjects aged 18 years of age or older | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| This investigation will compare values from the test device(s) to itself, or one of the reference parameters, or a combination of parameters, including NIBP, temperature, SpO2, respirations, and ECG. |  | unlimited | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-invasive Blood Pressure (NIBP), GE Monitor, Temperature, SpO2, Respiration, ECG