Healthy Volunteers
Conditions
Keywords
Patient safety monitors
Brief summary
Use of an investigational oximetry system to evaluate the triggering of the sensor off status with the marketed off-the-shelf sensors.
Detailed description
The Multi-functional Patient Monitoring PCBA is an electronic circuit board in the monitoring system that performs calculations. The study will evaluate the performance of the Sensor Off New Patient Monitoring system by exposing the sensor to an ambient light source, sensor slipping off the finger with the light emitter and detector facing each other or a sensor slipping off under a blanket.
Interventions
None listed
Sponsors
Medtronic - MITG
Study design
Observational model
CASE_ONLY
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Male or female subjects 18 years or older (inclusive) * Subject is able to participate for the duration of the study * Subject is willing to sign an informed consent
Exclusion criteria
* Previous injury or trauma to fingers or hands that may change blood flow or vascular supply and affect our ability to test sensors. * Physiologic abnormalities that prevent proper application of pulse oximetry sensor. * Severe contact allergies that cause a reaction to standard adhesive materials such as those found in medical sensors and electrodes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To validate that the device posts a Sensor Off message within one minute after the sensor is removed at least ninety percent of the time. | The planned duration of the study is 1 month. |
Countries
United States
Outcome results
None listed