Bilistick System Technical Data Sheet General Description of the System The Bilistick System is a Point-of-Care diagnostic device able to measure Total Serum Bilirubin (TSB) concentration on whole blood of newborn infants. It is composed by the Bilistick Reader, a hand held rechargeable battery reflectance reader; Bilistick Test Strips, test strips with a cell-plasma separator coupled with a nitrocellulose membrane, both encased in a plastic cassette; and Bilistick Sample Transfer Pipettes, used for loading the appropriate volume of blood on the strip. The test requires the collection of a small blood sample (25µL) directly from a heel stick or a tube by using the Bilistick Sample Transfer Pipette, and its application on a Bilistick Test Strip. The later separates the plasma from cells and allows the determination of TSB by reflectance spectroscopy using the Bilistick Reader. The TSB determination by the Bilistick System does not require the use of reagents simplifying the process of measurement. Intended Use The Bilistick System is intended for use in hospitals, clinics, doctor’s offices or family counseling under a physician supervision/direction to assist clinicians in monitoring the bilirubin levels in the blood of newborn infants. The System is not intended as a standalone for diagnosis of hyperbilirubinemia. It is to be used in conjunction with other clinical signs and laboratory measurements. Bilistick System Technical Specifications Sample Features Sample Type Newborn infant whole blood Sample Size Bilistick Reader Units Measure System Photometric based in two wavelength at 465 nm and 570 nm Till 25 mg/dL: Within ± 0.2 mg/dL / 3 µmol/L Over 25 mg/dL: Within ± 0.6 mg/dL / 10 µmol/L Test Time < 2 minutes depending on hematocrit Optical sensor Optical filters Glass protection inside the optical chamber

Standard for periodic calibration Blank self-calibration after Test Strip insertion Automatic system for hemolysis detection Results Report Color display, dimension 36.0 x 29.0 mm Operating Conditions Temperature: 15°C to 40°C Relative Humidity (non-condensing): 5 to 75% Storage Conditions 10 °C to 40 °C low humidity, non-corrosive gas atmosphere. Long-term Storage 1) In case of long-term storage, store the reader at 15-25 °C, low humidity, non-corrosive gas atmosphere. 2) When storing the reader for a period longer than six months, charge the battery at least once six months Power Supply Recommended...

Directives and conformity The Bilistick System has been projected and built in accordance with:           Directive IVD 98/79/EC of the European Parliament and of the council of 27 October 1998 on in vitro diagnostic medical devices UNI CEI EN ISO 13485 Medical devices -- quality management systems -- requirements for regulatory purposes UNI CEI EN ISO 15223-1 Medical devices -- symbols to be used with medical device labels, labelling and information to be supplied -- part 1: general requirements UNI CEI EN ISO 14971 medical devices -- application of risk management to medical devices...