Pack Insert
Contents
1. gt 9 Hb Hemoglobin Control Strip S Package Insert REF C121 3035 English For checking the performance of the Insight Hb Hemoglobin Meter optical system For in vitro diagnostic use only INTENDED USE The Insight Hb Hemoglobin Control Strip is a firm plastic strip onto which a brown reference pad is affixed on the back of the strip for checking the performance of the optical system of the Insight Hb Hemoglobin Meter The Insight Hb Hemoglobin Control Strip reference pad provides a standardized reflectance value as a reference for the optical system After the control strip is inserted into the meter the meter will compare the reflectance value to the pre calibrated value stored in the meter software The meter will display YES if the optical system is working properly or no if the optical system is not working properly Contact your local distributor for more details PRECAUTIONS For in vitro diagnostic use only The strip should remain in the closed canister until use Do not use after the expiration date Keep the control strip clean Do not touch the brown reference pad on the back of the strip Do not bend the control strip Do not use a contaminated discolored bent or damaged control strip STORAGE AND STABILITY Store as packaged in the closed canister at room temperature 2 30 C Keep out of direct sunlight extreme temperature and humidity Remove the strip for immediate use and put it back into the canister w2. ith which it was packaged after each use Close the canister immediately MATERIALS Materials Provided e Control strip s e Package insert Materials Required But Not Provided e Hb Hemoglobin Meter e User s manual DIRECTIONS FOR USE Allow the Insight Hb Hemoglobin Control Strips and Meter to reach room temperature 15 30 C prior to testing Refer to the Hb Hemoglobin Testing System User s Manual for detailed instructions 1 Remove a Insigh Hb Hemoglobin Control Strip from the closed canister Immediately close the canister tightly after removing the strip 2 Enter the Optical Check submenu from the Setup Screen Note Refer to the Instruction Manual for detailed test procedures 3 Wait for the meter to flash the strip symbol Insert the Control Strip completely into the Strip Channel in the same direction as the arrows printed on the strip Note Ensure the strip is inserted completely for accurate results 4 Press the middle button to start the Optical Check 5 If the meter displays YES the optical system is working properly Refer to the User s Manual for performing specimen testing as usual If the meter displays no the optical system is not working properly Repeat the test using a new Control Strip that has not been contaminated bent damaged or discolored 6 If the meter displays no after performing the test again contact your local distributor for further assistance LIMITATIONS 1 This Optical Check should be perf
3. ormed under normal lab lighting conditions 2 Do not perform this test under extreme overhead lighting conditions Index of Symbols Consult instructions ac BEY for use gg Use by REF Catalog E K Store between 2 30 C For in vitro diagnostic Contains sufficient for use only LOT Lot Number R ie taste taal Manufacturer ACON Laboratories Inc 10125 Mesa Rim Road MDSS GmbH San Diego CA 92121 USA Schiffgraben 41 30175 Hannover Germany Number 1150566201 Effectived date 2010 06 25
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