Acon On Call Vivid Quick Start Manual
Blood Glucose Control SolutionPackage InsertREF G125-122 EnglishPRINCIPLE AND INTENDED USEThe On Call® Vivid Control Solution contains a known concentration of glucose. It is used to confirm thatyour On Call® Vivid Test Strips and On Call® Vivid or On Call® Vivid Pal Blood Glucose Meter areworking together properly and that you are performing the test correctly.You should perform a quality control test:• Before you first use your meter to familiarize yourself with its operation.• Before using a new vial of test strips.• When you suspect that the meter or test strips are not working properly.• When you suspect that your test results are inaccurate, or if they are inconsistent with how you feel.• If you suspect your meter is damaged.• At least once a week.• After cleaning your meter.Three levels of control solution are available labeled Control Solution 0, Control Solution 1 and ControlSolution 2. Control Solution 1 is sufficient for most all self-testing needs. If you think your meter or stripsmay not be working correctly, you may also want to do level 0 or level 2 test.COMPOSITIONControl solution 0 contains less than 0.1% glucose (active ingredient), Control solution1 contains lessthan 0.2% glucose (active ingredient) and Control Solution 2 contains less than 0.4% glucose (activeingredient), all with preservatives in an aqueous based mixture.STORAGE AND HANDLING• Store the control solution at room temperature, 2-30°C (36-86°F).• Do not refrigerate or freeze.• If the control solution is cold, do not use until it has warmed to room temperature.• Use before the unopened expiration date that is shown on the bottle.Note: All expiration dates are printed in Year-Month format. 2013-01 indicates January, 2013.• Each bottle of control solution can be used for 6 months after you first open it. The control solutionwill expire 6 months after the bottle is opened for the first time. Record this opened expiration dateon the bottle label.PRECAUTIONS• For in vitro diagnostic use. The control solution is for testing only outside the body. Do not swallow orinject. For self-testing and professional use.• Shake well before using.• Control solution tests are specified to be accurate only when tested between 10 and 40°C(50-104°F).• The control ranges shown on the test strip vial are not a recommended range for your blood glucoselevel. Your personal blood glucose target ranges should be determined by your diabetes healthcareprofessional.• Do not touch the end of the test strip to the control solution bottle. This could cause contaminants toenter the control solution bottle.• Use only On Call® Vivid brand control solution with your On Call® Vivid or On Call® Vivid Pal brandmeter and On Call® Vivid Test Strips.MATERIALS PROVIDED• Control Solution • Package InsertMATERIALS REQUIRED BUT NOT PROVIDED• Meter • Test StripsINSTRUCTIONS FOR USE1. Insert a new test strip to turn on the meter. Refer to your meter’s User’s Manual details on how torecord the result as a quality control test and for further details on operating the meter.2. Shake the control solution bottle thoroughly.3. Squeeze the control solution bottle gently and discard the first drop. If the tip clogs, tap the tip gentlyon a clean, hard surface, shake again, and then use.4. Squeeze out a second small drop on a clean nonabsorbent surface. Touch the sample tip of the teststrip to the control solution drop and ensure the strip get sufficient sample.Notes: Do not apply control solution to the test strip directly from the bottle.If the control solution sample does not completely fill the check window, do not add a seconddrop. Discard the test strip and start over with a new test strip.5. Read the result from the meter display.EXPECTED RESULTSControl solution test results should be within the control range. The ranges for CTRL 0, CTRL 1 andCTRL 2 are displayed on the test strip vial (or on the foil pouch). For confirmation of results, ControlSolution 0 tests should fall within the CTRL 0 range, Control Solution 1 tests should fall within the CTRL1 range, and Control Solution 2 tests should fall within the CTRL 2 range. If the test results with controlsolution fall within the specified control range, it indicates your Blood Glucose Monitoring System isworking properly and you are performing the procedure correctly.If the control solution test results do not fall within the respective ranges:• Check the expiration date of the test strip and control solution. Make sure that neither the test stripvial nor the control solution bottle has been opened for more than 6 months. Discard any expired teststrips or control solution.• Confirm the temperature in which you are testing is between 10 and 40°C (50-104°F).• Make sure that the test strip vial and the control solution bottle have been tightly capped.• Confirm that you are using On Call® Vivid brand control solution.• Make sure that you followed the test procedure correctly.After checking all of the conditions listed above, repeat the control solution test with a new test strip. Ifyour results still fall outside the range indicated on the test strip vial label or on the foil pouch, your metermay not be working properly. DO NOT use the system to test blood. Contact your distributor for help.For complete instructions, please refer to the User’s Manual included with your meter. For additionalquestions or issues with this product, please contact your distributor for help.INDEX OF SYMBOLSConsult instructions foruse Use by AuthorizedRepresentativeFor in vitro diagnostic useonly Lot Number Control RangeStore between 2-30°C(36-86°F) Manufacturer REF Catalog #Number: 1150741201Effective date: 2014-03-03MDSS GmbHSchiffgraben 4130175 Hannover, Germany0123ACON Laboratories, Inc.10125 Mesa Rim RoadSan Diego, CA 92121, USAwww.acondiabetescare.com |
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