Introduction; About This Manual; Bilichek Description; Intended Use - Respironics BiliChek User Manual

BiliChek
user manual

1. Introduction

About This Manual

This User manual has been prepared for both first-time and experienced users of the BiliChek
System. This manual provides basic instructions for use and troubleshooting procedures. To ensure
safe operation of this product the user should read the entire instruction manual before operating
the unit. Save this manual for future reference.

BiliChek Description

The BiliChek provides a numerical measurement of predicted bilirubin count in mg/dL or µmol/L
within a clinically beneficial range that has been correlated with total serum bilirubin concentration
measured by High Pressure Liquid Chromatography (HPLC). The device is intended for use in the
hospital or institutional environment, including clinics, physician's offices, and home nursing agencies, to
assist clinicians in monitoring the status of neonates for the development of hyperbilirubinemia.

Intended Use

The BiliChek Non-Invasive Bilirubin Analyzer is a non-invasive transcutaneous bilirubinometer, which
is intended as an index to predict serum bilirubin levels prior to phototherapy (pre-phototherapy),
during, and post phototherapy in neonates, without regard to gender, gestational age, or body weight.
Neonates whose BiliChek test results are indicative of hyperbilirubinemia are evaluated by their
physician(s) for appropriate patient management.