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Table 1 Outline of test conditions/objectives for in vivo DBAC testing

From: Deep Bleeder Acoustic Coagulation (DBAC)—part II: in vivo testing of a research prototype system

 

Milestone

Most challenging problem

Milestone specification

Treatment speed

Device operation

DBAC hemostasis test condition/objective

Slow bleeder injury

Slow bleed in small vessel

5 ml/min

Achieve hemostasis

before 50 % blood loss.

Maximum time limit of 30 min

Full automation: start button, cancel button

Closed-loop system

Minimum of two panels required

Fast bleeder injury

Fast bleed in large vessel

100 ml/min

Depth of penetration

Large, fast, deep bleeder

12.5 cm

Maximum thermal tissue dose

Large, fast, deep bleeder

Thermal lesioning limited to 2-cm sphere centered on the bleed

 

Maximum thermal skin dose

Skin burn

MTSD ≤ 52 °C