Goals:

Determine accuracy of SmO2 and pHm values from CareGuide sensors

• To be included in FDA 510(k) submissions
• Blood circulation isolated to muscles being measured by CareGuide
• SmO2 range of 10-85%, pHm range of 6.9-7.5

Roles:

• Surgical protocol development to isolate limb and maintain limb during testing
• Testing protocol development to isolate effects of changing SmO2 or pHm
• Co-author of IACUC and FDA testing protocols
• Tech support of CareGuide systems during studies

Results:

Successful completion of 2 validation studies

• 2 approved FDA 510(k) submissions- one for SmO2, one for pHm
• Paper on validations published in journal Physiological Measurement