ivWatch Model 400: Device Validation for Non-Infiltrated Tissues

Experimental: Non-Infiltrated Tissue

The ivWatch Model 400 monitored a common peripheral IV site over a 24 hour observation period.

Dispositivo: ivWatch Model 400

The ivWatch Model 400 monitored tissue at common IV sites over a 24 hour period.

Normal Tissue Red Notification Rate

The ivWatch Model 400 issues red notifications to communicate the need for a clinician to check an IV site. A red notification suggests an increased likelihood that an IV infiltration may be occurring, with a greater likelihood relative to a yellow notification. This measure describes the average number of red notifications issued by the ivWatch device in a given day when monitoring normal, non-infiltrated tissues. The 95% confidence interval for the red notification rate was calculated using the Clopper-Pearson method.

Normal Tissue Yellow Notification Rate

The ivWatch Model 400 issues yellow notifications to communicate the need for a clinician to check an IV site. A yellow notification suggests an increased likelihood that an IV infiltration may be occurring, although at a lower likelihood relative to a red notification. This measure describes the average number of yellow notifications issued by the ivWatch device in a given day when monitoring normal, non-infiltrated tissues. The 95% confidence interval for the yellow notification rate was calculated using the Clopper-Pearson method.

Significant Skin Irritation or Disruption to Skin Integrity

The number of IV sites with significant skin irritation or disruption to skin integrity assessed at the end of the study. The Clopper-Pearson method was used for estimating the binomial proportion confidence interval.