Suggested BiliChek174; Usage Protocol Access （建议BiliChek174;）.pdf

Suggested BiliChek® Usage Protocol I. Subject: BiliChek® Non-Invasive Bilirubin Analyzer II. Purpose: To outline and define the use of the BiliChek Non-Invasive Bilirubin Analyzer in the hospital setting which may include the Newborn Nursery, Neonatal Intensive Care Unit, Outpatient Clinic, Laboratory, Home Nursing Agency and/or Emergency Department. III. Scope: The BiliChek Non-Invasive Bilirubin Analyzer is approved for use as an accurate predictor of total serum bilirubin (TSB) in infants and neonates. Intended use: • Pre, during and post phototherapy • Gestational age: 27-42 weeks • Post-natal age: 0-20 days • Weight range: 950-4995 grams IV. Clarification Definitions: • The BiliChek Non-Invasive Bilirubin Analyzer device is an alternative to subcutaneous (traditional heel stick TSB) bilirubin testing as correlated to High Performance Liquid Chromatography. Because BiliChek is non- invasive there is no pain, trauma or risk of infection to the patient. • The BiliChek performance has been clinically proven in patients within the following parameters: o Gestational Age: 27 to 42 weeks o Postnatal Age: 0 to 20 days o Weight: 950 to 4995 grams • The BiliChek should not be used in the following situations: o Following exchange transfusion o The measurement site on the forehead contains excessive bruising, birthmarks, hematomas or excessive hairiness at this can produce erroneous results. • Only properly trained hospital personnel should perform BiliChek testing. Such personnel may include: