Clinical Performance of Masimo INVSENSOR00057 for Heart Rate Measurements

Masimo Corporation86 enrolled

Overview

This study is designed to compare the accuracy of a noninvasive measurement of heart rate compared to reference values obtained by a standard of care ECG monitor.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

Masimo INVSENSOR00057DEVICE

Noninvasive wearable health monitoring device

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Subject is 18 to 80 years of age. * Subject is able to read and communicate in English. Exclusion Criteria: * Subject has open wounds, inflamed tattoos or piercings on the area of device placement, and/or has any visible healing wounds that the investigator and/or medical professional determines may place them at an increased risk for participation. * Subject has any medical condition which in the judgment of the investigator and/or study staff, renders them ineligible for participation in this study or subject is deemed ineligible by the discretion of the investigator/study staff.

Locations (1)

Masimo Corporation

Irvine, California, United States

Outcomes

Primary Outcomes

Heart Rate Accuracy of Masimo INVSENSOR00057

Heart rate accuracy was determined by calculating the accuracy root mean-squared (Arms) difference between the measured values from Masimo INVSENSOR00057 (TestHR\_i) to the reference ECG monitor values (RefHR\_i). Arms= √(∑(i=1 to n) ((TestHR\_i-RefHR\_i )\^2 ))/n

Time frame: 1-3 hours

Data from ClinicalTrials.gov

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