Joe Costello Design
 

Mobile Military

Triage Device

 
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Our team was commissioned to give physicality to an innovative, blood monitoring algorithm that existed on a small set of printed circuit boards. The device would calculate and display heart rate, blood-oxygen (SpO2) and the Compensatory Reserve Index (CRI) using one, simple finger-clip sensor input. CRI is a breakthrough hemodynamic parameter that provides real-time, noninvasive indication of changes in intravascular volume relative to the individual patient’s response to blood loss. Put simply, how much blood is in the patient as a percentage of maximum.

 
 
 
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DESIGN CONSIDERATIONS:

• Design Enclosure

• 2.4” Display

• High Impact Body

• Sterilizable Plastic Materials

• IP33-rated

• MIL-spec

• 2-shot Injection Mold

• Two-button Operation

• One replaceable AA Battery

• Hinged battery door

• Sealed Battery Compartment

• Weatherproof Connectors:
DB9 and Micro USB

• Insert-molded Lanyard Clip

• Possible Secondary Belt Clip

• 2 Color Schemes

 
 
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Context

This device was first targeted for use in a military medevac environment. Several stringent requirements had to be met to endure the testing and approval process.

 
 
 
 

Early Concepts

 
 
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CONCEPT 1

CONCEPT 1

CONCEPT 2

CONCEPT 2

CONCEPT 3

CONCEPT 3

 
 
 

Concept Refinement Phase - cONCEPT a

 
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Concept Refinement Phase - cONCEPT b

 
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Initial Prototype - rEVISION a

 
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20 prototypes of Revision A were built for field testing and manufacturing viability.

 
 
 
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Final Prototype - rEVISION b for Military Testing 

Feedback from Revision A resulted in several changes: battery door sealing strategy, button size, and the addition of a insert-molded lanyard clip.

 
 
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Results:

On July 24, 2018, Flashback Technologies, Inc. was granted 510(k) clearance by the U.S. FDA for this, now dubbed the CipherOx® CRI M1 monitor. The M1 is Flashback’s first commercial CRI product to market and commercial sales of the M1 are expected to begin soon. Read the press release here.