IS20A46 2002-06-10 15:04 Page 1 GLASS ENCAPSULATED CALIBRATOR SOLUTION FOR SWEAT-CHEKª CONDUCTIVITY ANALYZER For In Vitro Diagnostic Use Intended Use WescorÕs CALIBRATOR solution is for calibration of the Sweat-Chek Sweat Conductivity Analyzer. Product Description WescorÕs CALIBRATOR solution is liquid, ready to use, and requires no reconstitution or dilution. Each ampule contains 0.75 mL of NaCl solution, at 90 mmol/L molarity. Warnings and Precautions No special precautions are required in handling the product other than those routinely used in the laboratory. Storage and Stability 1. CALIBRATOR should be stored at room temperature. 2. Each ampule contains 0.75 mL of solution. This volume adequately mitigates evaporative concentration for a few hours after the ampule is broken. Ampules are intended for one-time use only. Instructions for Use 1. Invert gently to ensure homogeniety of the contents. 2. Before opening, flip the neck of the ampule or tap the ampule bottom against a hard surface to clear solution from the neck. 3. Place the ampule in the ampule breaking position of the organizer. 4. Place the safety sleeve over the neck of the ampule. 5. Holding ampule organizer down against the counter, grasp the neck of the ampule firmly between thumb and forefinger and snap the neck off. 6. Sample directly from the ampule, using a fresh Sweat-Chek take up tube to avoid contamination of the solution. 7. Follow procedures in UserÕs Manual to assay CALIBRATOR solution. Expected Values The Sweat-Chek conductivity cell has an extremely stable response characteristic that is virtually linear through the critical range from 75 to 110 mmol/L. The main purpose of calibration is to ascertain that the conductivity cell temperature is within the correct range and that the electronics are otherwise functioning normally. If the conductivity cell is free of residual salt or water, a reading within ± 2 of the labeled value of 90 mmol/L indicates overall performance to a very high level of confidence. If the reading falls outside of this range, follow the instructions listed in the UserÕs Manual for calibrating the instrument. Catalog Number SS-140 Wescor, Inc 459 South Main Street, Logan, Utah 84321 USA 800 453 2725 435 752 6011 Fax: 435 752 4127 IS20A46