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The ivWatch Model 400 is indicated for the detection of subcutaneous infiltrations and extravasations of 10cc or less of optically clear infusates, as an adjunctive device to the clinical evaluation in the healthcare setting of adults and pediatrics with peripherally-inserted catheters (PIVs).
The device is indicated to assess patients for subcutaneous infiltrations and extravasations but should not serve as a substitute for regular clinician assessment of the PIV site. The ivWatch Model 400 is intended for use by healthcare practitioners who have been trained in the use of the device.
The ivWatch Model 400 is intended to aid in the detection of infiltrations and extravasations during peripheral IV infusion therapy in pediatric and adult patients. The user profile is healthcare practitioners who are experienced in IV administration and management and located at hospitals and similar medical care facilities.
The ivWatch Model 400 is not intended for use with power injectors. The ivWatch Model 400 may have reduced sensitivity if used with dark, colored or cloudy fluids.
USE OF THE DEVICE AS AN AID TO DETECTION OF SUBCUTANEOUS IV INFILTRATION
The ivWatch Model 400 must only be used as an adjunct to regular assessments of IV placement by clinicians.
The device cannot serve as a substitute for regular clinician assessment, and should not be used in the absence of standard clinical supervision and procedures that are typically utilized (i.e. when the device is not used) for detection of subcutaneous infiltrations and extravasations.