1150490802 DTG Clarity plus Blood Glucose manual-En
Contents
1. Rotation of sites is recommended Repeated punctures in the same spot can make your fingers sore and calloused 19 eS Forearm or Palm at the base of the thumb Testing The forearm and palm areas have fewer nerve endings than the fingertip so you may find that obtaining blood from these sites is less painful than from the fingertip The technique for forearm and palm sampling is different You need the clear cap to draw blood from these sites The clear cap is not adjustable for puncture depth IMPORTANT There are important differences between forearm palm and fingertip samples that you should know Important information about forearm and palm glucose testing e When blood levels are changing rapidly such as after a meal insulin dose or exercise blood from the fingertips may show these changes more rapidly than blood from other areas Fingertips should be used if testing is within 2 hours of a meal insulin dose or exercise and any time you feel glucose levels are changing rapidly e You should test with the fingertips anytime there is a concern for hypoglycemia or you suffer from hypoglycemia unawareness Please refer to Fingertip Testing to insert the lancet and load the lancing device 1 Screw the clear cap onto the lancing device 2 Choose a puncture site on the forearm or palm Select a soft fleshy area of the forearm that is clean and dry away from bone and free of visible veins and2. This is expected but the difference under normal operating conditions should be no greater than 20 To ensure a reasonable comparison follow these guidelines Before you go to the lab Bring your meter test strip and control solution with you to the lab Make sure your meter is clean Perform a quality control test to make sure the meter is working properly Comparisons will be more accurate if you do not eat for at least four hours preferably eight hours before testing At the lab e Wash your hands before obtaining a blood sample Obtain blood samples for a laboratory test and for your meter within 10 minutes of each other This will ensure an accurate comparison of results Never use your meter with blood that has been placed in test tubes containing fluoride or other anticoagulants This will cause falsely low results 30 Troubleshooting Guide The meter has built in messages to alert you of problems When error messages appear note the error number turn off the meter and then follow these instructions Causes Solution Battery may be damaged or not be charged Repiace paltery if meter has been exposed to or stored in cold conditions wait 30 Meter is too cold minutes to allow meter to reach room temperature then repeat test Remove battery for 30 seconds and then put battery back and turn meter on again If problem persists If problem persists contact Clarity Customer Technical suppor
3. are getting correct results You should run a quality control test Before you first use your meter to familiarize yourself with its operation Before using a new box 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 When you suspect your meter is damaged After cleaning your meter At least once a week Refer to Quality Control Test on page 14 for instructions on running a quality control test E Storage and Handling Install the Battery Please review the following storage and handling instructions 4 Battery may not be preinstalled in the meter One CR 2032 3 0V coin y ToN spon ales arse at room temperature 15 30 C 59 86 F cell battery is required Please find the battery in your carrying case and BIRR eer ena MIGAS a install it according to following steps Ifthe control solution is cold do not use until it has warmed to room temperature P Use before the unopened expiration date that is shown on the t er oh ee siesta pats bottle A Note The expiration date is printed in Year Month format 2010 01 opened WEY YOU ORG means January 2010 Each bottle of control solution can be used for 3 months after you first open it The control solution will expire 3 months after the bottle is opened for the first time Record this opened expiration date on the bottle l
4. display will show three dashed lines the word MEM and the unit of measure This shows that no data have been stored in memory mg dL MEM 2 The date and time will be displayed together with the results stored in memory A pound sign indicates records that will be omitted from the 7 14 and 30 day averages 3 Press the M button to go through the stored records 4 Press the S button to view the data averages The words DAY AVE will appear on the screen Note If you do not wish to view your average glucose measurements you can press the S button again to turn off the display 25 26 5 While in memory mode press the M button to switch between the 7 14 and 30 day averages The meter will calculate the average that you selected The number of records used in the DAY AVE will also appear in the display 6 If there are fewer than 7 14 or 30 days in memory all the unmarked readings currently stored in memory will be averaged instead If you are using the meter for the very first time no value will appear on the display This means that no records have been stored in memory 7 Press the S button to turn off the display Note Results from quality control tests will not be included in the averages When viewing results in memory these values are marked with a pound sign to show that they will not be included in the 7 14 and 30 day averages Clearing the Memory Extreme caution should be
5. lancets together to measure your blood glucose concentration Step 1 Getting a Drop of Blood The Clarity Plus Blood Glucose Monitoring System requires a very small sample of blood which may be obtained from the fingertip palm at the base of the thumb or forearm See page 20 for information on obtaining a blood sample from the palm or forearm Before testing choose a clean dry work surface Familiarize yourself with the procedure and make sure you have all the items needed to obtain a drop of blood IMPORTANT Prior to testing wipe the test site with an alcohol swab or soapy water Use warm water to increase blood flow if necessary Then dry your hands and the test site thoroughly Make sure there is no cream or lotion on the test site Cocking Barrel Lancet Holder Clear Cap for testing on Sterile Lancet forearm and palm reri Safety Tab Release Button Puncture Depth Lancing Device Settings Cover 17 G Fingertip Testing For fingertip sampling adjust the depth penetration to reduce the discomfort You do not need the clear cap for fingertip sampling 1 Unscrew the lancing device cover from the body of the lancing device Insert a sterile lancet into the lancet holder and push it until the lancet comes to a complete stop in the lancet holder 2 Hold the lancet firmly in the lancet holder and twist the safety tab of the lancet until it loosens then pull the safety tab off the lancet Save the safety
6. tab for lancet disposal 3 Carefully screw the cover back onto the lancing device Avoid contact with the exposed needle Make sure the cover is fully sealed on the lancing device 4 Adjust the puncture depth by rotating the lancing device cover There are a total of 5 puncture depth settings To reduce the discomfort use the lowest setting that still produces an adequate drop of blood Adjustment 18 1 and 2 for delicate skin 3 for normal skin 4and5 for calloused or thick skin Note Greater pressure of the lancing device against the finger will also increase the puncture depth Pull the cocking barrel back to set the lancing device You may hear a click The device is now loaded and ready for obtaining a drop of blood Prior to testing wipe your hand with an alcohol swab or wash your hands with soap Use warm water to increase blood flow in your fingers if necessary Then dry your hands thoroughly Massage the hand from the wrist up to the fingertip a few times to encourage blood flow Hold the lancing device against the side of the finger to be lanced with the cover resting on the finger Push the release button to prick your fingertip You should hear a click as the lancing device activates Gently massage from the base of the finger to the tip of the finger to obtain the required blood volume Avoid smearing the drop of blood For the greatest reduction in pain lance on the sides of the fingertips
7. used when clearing the memory This is not a reversible operation To clear the memory 1 With the meter powered off press and hold the M button for three seconds This will turn on the meter and enter the delete mode K D 2 To clear the memory press and hold both the L M and S buttons for two seconds a 3 The display will show MEM and the meter will clear its memory and after a moment turn itself off 4 If you entered the delete mode but want to exit without deleting the recorded data press the S button This will turn the meter off without deleting any data 27 Maintenance Proper maintenance is recommended for best results Replacing the Battery When the battery icon appears it means the battery is running low and you should replace the battery as soon as possible An E 6 error message will appear if the battery is too low to perform any more blood glucose tests The meter will not function until the battery is replaced Instructions 1 Make sure the meter is off before removing the battery 2 Pull the battery carrier on the left side of the o meter The battery carrier should be easily opened with you finger Remove and discard the old battery Replace it with a fresh CR 2032 3 0V coin cell battery Make sure it is aligned with the side facing up in the battery carrier Close the battery carrier and make sure that it snaps shut Recheck and reset the clock setting as necessary af
8. 22 Hi and LO M6SSages vache eset tenner 24 Using the Meter Memory cccssccssscceeeeeeceeeseeeeesseeeseseeeeeeseeeesneees 26 Viewing Stored ReECOMMS csore enea Ea aA AEAEE 26 Cleaning the Memory soassa ee A EEEE 27 Maintenance ccccccccceeceeeseeeeeeeeseeeseeessceeseeesaceeseeeseeeseneeeenesneesasenees 28 Replacing the Battery sisiring Anaia 28 Caring for Your Clarity Plus Blood Glucose Monitoring System c ccceeeeeeeeeeeeeeteeeeteeees 28 Suggested Testing Times and Target Goals ccccceseceeseeeeeeee 29 Comparing Meter and Laboratory Results ccsccessseeeeseeeeeeeee 30 Troubleshooting Guide cccsesccsccessessececeesnecseasenesesseecssansecene 31 Specifications 33 Warranty 34 Index 35 Getting Started lt Before testing read the instructions carefully and learn about all the Blood Glucose Meter Reads the test strips and displays the blood components of your Clarity Plus Blood Glucose Monitoring System glucose concentration Depending on the Clarity Plus product you purchase some of the components may need to be purchased separately Please check the list of contents on the outer box for details on which components are included with your purchase 3 Code Chip Automatically calibrates the meter with the code number when inserted into the meter 2 Test Strips Strips with a chemical reagent system used with the meter to measure glucose concentr
9. Clanty Diagnostics LLC Boca Raton Flonda 33487 Tech Support 1 877 485 7877 www claritydiagnostics cont Glarity Diagnostics LLC All rights reserved Manufactured for Clarity Diagnostics LLC Made in China Number ti Eftnetive dat 2014307 Blood Glucose Monitoring System Self monitoring of blood glucose SMBG is an integral part of diabetes care but the high cost of testing can make this impossible At Clarity our goal is to provide high quality glucose monitoring at a price that allows you to test as often as necessary Together we can better manage your diabetes and help you live a longer and healthier life Welcome and thank you for choosing the Clarity Plus Blood Glucose Monitoring System The Clarity Plus Blood Glucose Monitoring System will give you accurate blood glucose results in just a few simple steps To ensure accurate results from your Clarity Plus Blood Glucose Monitoring System please follow these guidelines Read instructions before use Use the code chip that accompanies each box of test strips Use only Clarity Plus Blood Glucose Test Strips with the Clarity Plus Blood Glucose Meter For in vitro diagnostic use only Your blood glucose monitoring system is to be used only outside the body for testing purposes For self testing and professional use Test only whole blood samples with the Clarity Plus Blood Glucose Test Strips and Meter For self testers consult your physician
10. L Test Time 10 seconds Power Source One 1 CR 2032 3 0V coin cell battery Battery Life 12 months or approximately 1 000 tests The meter is pre set to milligrams per Glucose Units of Measure deciliter mg dL Memory Up to 300 records with time and date Meter Size 85mm x 54mm x 20 5mm Display Size 35mm x 32 5mm Weight Approximately 49 5 g with battery installed Operating Temperature 5 45 C 41 113 F Operating Relative Humidity 20 90 non condensing Hematocrit Range 30 55 Averaging Resullts 0 26 Battery Replacing the 28 Carrying CaSe 1 Clearing the Memory 27 Data Port cesses 3 Date Format cs cccsseee 7 9 Guidelines ccceseseeeeeeeeees i Hematocrit cscceeee 24 33 Install the Battery 00 10 Lancing Device 1 17 28 Lancet cccssesessseeeesstees 1 17 LOQDOOK cei cceicers cece ince 2 29 Maintenance and Disposal 5 28 Measure Unit of 4 15 Meter ccesicsitscdccenssstssscsassccavisssrsasnis 3 Audio feature 13 ClaN eiiieaen 28 Code GRID ersen 2 Display Error Messages 31 HI and LO Messages 24 M Button eee 3 MOM OM erana 26 Meter code 0 0 cc ee 11 Meter Setup c ccccceeees 11 Meter Use and Precautions 5 S BUON siiiu 3 Set the Clock Specifications 35 Procedure Prec
11. Solution 12 Warranty Card Should be completed and returned to Clarity Diagnostics to qualify for the 5 year meter warranty Carrying Case r Clarity Plus Blood Glucose Meter The meter reads the test strips and displays the blood glucose concentration Use this diagram to become familiar with all the parts of your meter Strip Port Battery Carrier Liquid Crystal Display LCD m Code Chip Code Chip Slot j 16 88 2 06 08 a M Button S Button Data Port Liquid Crystal Display LCD Shows your test results and helps you through the testing process M Button Recalls previous test results from the meter memory and performs other menu selection functions S Button Selects meter settings performs other menu selection functions Strip Port Test strips are inserted into this area to perform a test Battery Carrier The battery carrier is located on the back of the meter Code Chip Slot Insert the code chip here Code Chip For coding the meter A new code chip comes with every box of test strips Data Port Not Currently Available for Use Meter Display Pound Sign Control Solution Symbol Appears with the control solution Indicates a control test result A test result or when you mark an pound sign will also be invalid result to prevent it from displayed when control solution being included in the averages symbol appears Month Day Hour Minutes Test Strip and Blood D
12. abel 2 Place a fresh CR 2032 3 0V coin cell battery Make sure it is aligned with the side Control Solution Precautions facing up in the battery carrier For in vitro diagnostic use The control solution is for testing only outside the body Do not swallow or inject Shake well before using Control solution tests are specified to be accurate only when tested between 15 and 40 C 59 104 F The control ranges shown on the test strip vial are not recommended ranges for your blood glucose level Your personal 3 blood glucose target ranges should be determined by your diabetes healthcare professional Do not touch the test strip with the tip of the control solution bottle Use only the same brand of control solution that was provided with your kit Close the battery carrier and make sure that it snaps shut See the control solution insert for more details Before testing the following steps should be followed Step 1 Coding the Meter Simply insert the code chip to code the meter Every time you change to a new box of test strips you need to insert the code chip packed with the new box of test strips You can see the code number appears on the meter Make sure this number matches the code number printed on the test strip vial label and the number printed on the code chip You can easily find a code chip in your starter kit box This code chip is used with the test strip packed in your carrying cas
13. ances will produce falsely high blood glucose measurements Using the Meter Memory e Fatty substances Triglycerides up to 3 000 mg dL or Cholesterol up The meter automatically stores up to 300 test records Each record to 500 mg dL have no major effect on blood glucose test results includes the test result time and date If there are already 300 records in The Clarity Plus Blood Glucose Monitoring System has been tested memory the oldest record will be erased to make room for a new one and shown to work properly up to 8 516 ft 2 595 meters The meter will also calculate the average values of records from the last e Severely ill persons should not run the glucose test with the Clarity 7 14 and 30 days Plus Blood Glucose Monitoring System Blood samples from patients in shock or with severe dehydration or from patients in a hyperosmolar state with or without ketosis have Viewing Stored Records not been tested and are not recommended for testing with Clarity Plus Blood Glucose Monitoring System Dispose of blood samples and materials carefully Treat all blood To view stored records samples as if they are infectious materials Follow proper 1 Press the M button to turn the meter on and enter memory mode precautions when disposing of materials The most recent value and the word MEM will appear on the display eB tsa mit CLs JEM mg dL If you are using the meter for the very first time the meter
14. arning when an error has occurred Please check the error number on the display to confirm what kind of error has occurred Press the M button to switch between turning the meter beep On and Off Press the S button to confirm your selection Pressing S at this point will end the setup mode and power off the meter R ud oa Aud 10 ME Eio M WV UA 13 Performing a Quality Control Test The quality control test confirms that the test strips and meter are working together properly and that you are performing the test correctly It is important to perform this test Before you first use your meter to familiarize yourself with its operation Before using a new box 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 When you suspect your meter is damaged After cleaning your meter At least once a week Insert a test strip into the strip port contact bars end first and facing up to turn on the meter and display all the display segments If the audio option is on the meter will beep signaling the meter is turned on IETSIE LI 00 0 mmol L mg dL MEM CODE Check the display to confirm that all the display segments turn on see display illustration above Following this display check the system will 1 38 0 50 au enter t
15. at the test strip vial and control solution bottle have been tightly capped Make sure code number on the strip vial label matches the code number that appears on the meter display Confirm that you are using the same brand of control solution that was provided with your kit Make sure that you followed the test procedure correctly After checking all of the conditions listed above repeat the quality control test with a new test strip If your results still fall outside of the control range shown on the test strip vial your meter may be defective Contact Clarity Customer Technical Support at 1 877 485 7877 Two levels of Control solutions are available labeled Low Control and High Control The ranges for both Low and High Control are displayed on the test strip vial For confirmation of results Low Control results should fall within the Low control range and High control results should fall within the High control value range If the control solution test results do not fall within the respective ranges DO NOT use the system to test blood as the system may not be working properly If you cannot fix the problem contact Clarity Customer Technical support at 1 877 485 7877 Please contact Clarity for information on ordering the Clarity Plus Glucose Control Solution Kit which contains Low and High Controls 16 Testing Your Blood The following steps show how to use the meter test strips lancing device and sterile
16. ation in blood 4 Lancing Device Used with sterile lancets to prick the fingertip palm at the base of the thumb or forearm for blood sample collection The packaged lancing device has multiple depth settings allowing users to adjust the depth of the puncture and minimize discomfort 5 Clear Cap Used with the lancing device and sterile lancet to draw blood sample from the forearm and palm 6 Sterile Lancets Used with the lancing device to draw a blood sample Sterile lancets are inserted into the lancing device with Test Strips each blood draw and discarded after use 7 Control Solution Verifies the proper operation of the blood glucose D monitoring system by checking the test strips and meter against a precalibrated control solution The two levels of control solution Blood Glucose Meter Code Chip Low Control and the High Control are available in the Clarity Plus Glucose control solution package sold seperately 8 Carrying Case Provides portability for blood glucose testing le wherever you go 9 User s Manual Provides detailed instructions on using the blood Lancing Device Clear Cap glucose monitoring system 10 Quick Reference Guide Provides a brief overview of the blood glucose monitoring system and testing procedures This small guide can be kept in your carrying case ame 11 Logbook Allows users to record their blood glucose data and get a better picture of their broader trends Sterile Lancet Control
17. autions and Limitations 24 Testing Your Blood 0 17 Quality Control Test 14 Control Solution 8 HOW tO RUN eiiis 14 Results Blood Glucose 23 Control Solution 15 Meter vs Lab Results 30 Target Gols 29 Unit of Measure 0 0 15 29 Suggested Testing Times 29 Test Sth pistcicsrtresrcctere eave 5 Oo AEE TETTI EET 6 Expiration T Precautions 8 Testing Your Blood 17 Get a Drop of Blood 17 Test Blood Glucose 22 Troubleshooting 31 Viewing Stored Records 26 Warranty rosee 2 34
18. d Glucose Looe larity Plus Test Strips Lot 390001 Exp 2010 01 Contents 50 Test Strips Eoch wep contains Glucose oxidase Clarity Diagnostics LEC CTRL High from aspergis Each package of test strips is printed with a code number CODE lot number Lot unopened expiration date Exp and Low and High Control E Storage and Handling Please review the following storage and handling instructions Store test strips in a cool dry place at room temperature 15 30 C 59 86 F Store them away from heat and direct sunlight Do not freeze or refrigerate Do not store or use test strips in a humid place such as a bathroom Do not store the meter the test strips or control solution near bleach or cleaners that contain bleach Replace the cap on the test strip vial immediately after removing a test strip The test strip should be used immediately after removing it from container Do not use your test strips past the unopened expiration date printed on the label Using test strips past the unopened expiration date may produce incorrect test results Note The expiration date is printed in Year Month format 2010 01 means January 2010 B Special Instructions for Test Strip in the Vial Test strips should be stored tightly capped in their protective vial to keep them in good working condition Do not store test strips outside their protective vial Test strips must be stored in the original vial with the cap
19. e when you first open the carrying case If there is already one code chip inserted remove it and insert the new code chip 1 Take the code chip from the test strip box Compare the code number on the code chip with the code number printed on the test strip vial label If the two numbers are not identical you may get inaccurate results If the code number on the code chip does not match the number on the vial of strips with which it was packaged please contact Clarity Diagnostics immediately 2 With your meter turned off insert the new code chip into the code chip slot of the meter It should easily snap into place The code chip should remain in the meter do not take it out until you change to another new box of test strips 135 CODE 135 CTRL High N Note If a test strip is inserted and no strip code is stored in memory the display will flash CODE 11 Step 2 Adjusting the Meter Settings Adjust the meter settings to set the clock ensuring that results stored in the memory are shown with the correct date and time You can also turn the meter audio feature on or off You need to adjust the meter settings before you first use your meter You will need to set the clock settings after replacing the battery 1 Press the S button to enter the meter setup mode The meter will automatically enter the setup mode when turned on for the first time by any method 2 First
20. fore or after exercise e Before dinner 1 2 hours after dinner Before bedtime e After a snack At2 or 3 AM if taking insulin You may need to test more often whenever e You add or adjust your medication for diabetes e You think your blood glucose levels may be too low or too high You are ill or feeling uncomfortable over long periods of time Expected blood glucose levels for people without diabetes Time Range mg dL Fasting and Before Meals 70 100 2 Hours after Meals Less than 140 Time of Day Your Target Range Waking up Fasting level Before meals 2 hours after meals Bedtime 2 AM to 3AM Other Use the logbook to record your blood glucose measurements and related information Bring the logbook with you when visiting your physician so that you can determine how well your blood glucose is being controlled This can help you and your health care professional make the best decisions about your glucose control plan 1 Jennifer Mayfield and Stephen Havas Self Control A Physician s Guide to Blood Glucose Monitoring in the Management of Diabetes An American Family Physician Monograph 2 ADAClinical Practice Recommendations 2003 29 and Laboratory Results Your Clarity Plus Blood Glucose Monitoring System and laboratory results both report the glucose concentration in the serum or plasma component of your blood However the results may differ somewhat due to normal variation
21. h work with the Clarity Plus Blood Glucose Meter to measure the glucose concentration in whole blood After the strip is inserted into the meter blood is applied to the sample tip of the test strip then automatically absorbed into the reaction cell where the reaction takes place A transient electrical current is formed during the reaction and the blood glucose concentration is calculated based on the electrical current detected by the meter then the result is shown on the meter display The meter is calibrated to display plasma equivalent results Sample Tip Apply blood or control solution here E a Check Window Contact Bars Check to confirm that sufficient Insert this end of the test strip sample has been applied into the meter until it stops IMPORTANT Apply sample only to the sample tip of the test strip Do not apply blood or control solution to the top of the test strip as this may result in an inaccurate reading lt 7 Correct Incorrect Hold the blood drop to the sample tip of the test strip until the check window is full and until the meter begins to count down If the check window does not fill do not add more blood to the test strip You may get an E 5 message or an inaccurate test result Discard the strip and retest Even if the meter begins to countdown but the check window does not fill discard the strip and begin the test again with a fresh test strip Correct Incorrect E Code Number Oo Bloo
22. hair To bring fresh blood to the surface of the puncture site massage the puncture site vigorously for a few seconds until you feel it getting warm 20 3 Place the lancing device against the puncture site Press and hold the clear cap against the puncture site for a few seconds Press the release button of the lancing device but do not immediately lift the lancing device from the puncture site Continue to hold the lancing device against the puncture site until you can confirm a sufficient blood sample has formed B Disposal of the Lancet 1 Unscrew the lancing device cover Place the safety tab of the lancet on a hard surface and carefully insert the lancet needle into the safety tab 2 Press the release button to make sure that the lancet is in the extended position Pull the lancet straight out of the lancet holder and discard it in an appropriate container Place the lancing device cover back on the lancing device Lancet Precautions Do not use the lancet if the safety tab is missing or loose when you take the lancet out of the bag Do not use the lancet if the needle is bent Use caution whenever the lancet needle is exposed Never share lancets or the lancing device with other people In order to reduce the risk of infection from prior use of the instrument always use a new sterile lancet Do not reuse lancets Avoid getting the lancing device or lancets dirty with hand l
23. he test mode The display will show the e date and time and the strip icon with the blood sample icon blinking The code number will be J r displayed in the center of the screen Make I sure that the code number that appears on the display matches the code number CODE CODE on the test strip vial If not make sure to locate and insert the code chip that came with the box of strips If the codes still do not match do not perform a test You will need a new package of test strips to perform a test The blinking test strip and blood drop icon indicates that the test strip is inserted correctly and a drop of control solution can be added Note If the test strip has been inserted incorrectly the meter will not turn on 14 Press the M button to mark the test as a control solution test Once the M button is pressed the control solution symbol will appear on the display 5 Shake the control solution bottle well then squeeze it gently and discard the first drop If the tip clogs tap the tip gently on a clean hard surface shake again and then use Squeeze the vial again to get another drop and place the drop on your finger tip or other clean non absorbent surface first Then apply the drop to the sample tip of the test strip or touch the sample tip of the test strip to the control solution drop If the audio option is turned on the meter will beep to indicate a sufficient sample has been applied Notes Do n
24. ill consistently measured as HI it indicates severe hyperglycemia high blood glucose You should contact your healthcare professional immediately If LO appears on the display the measured concentration value is below 20 mg dL The test should be retaken to ensure that no mistake was made in the procedure If you are certain the meter is functioning properly and no mistakes were made in the procedure and your blood glucose is still consistently measured as LO it may indicate severe hypoglycemia low blood glucose You should treat yourself for hypoglycemia immediately as recommended by your healthcare professional Precautions and Limitations 28 050 Hi eB iSo v1 L L The meter test strips and other components have been designed tested and proven to work together effectively to provide accurate blood glucose measurements Do not use components from other brands Use only with whole blood Do not use with serum or plasma samples Do not use for testing newborns Do not use the meter in any manner not specified by the manufacturer Otherwise the protection provided by the meter may be impaired Very high above 55 and very low below 30 hematocrit can cause false results Talk to your healthcare professional to find out your hematocrit level 24 e Abnormally high levels of Vitamin C ascorbic acid Acetaminophen Uric Acid L Dopa Tolazamide or other reducing subst
25. k invalid results and to prevent them from being included in the 7 14 and 30 day averages press the M and S buttons together A pound sign will appear on the display to show that the result will not be included when calculating the 7 14 and 30 day averages If a result is marked by accident press the M and S buttons again to unmark the result After marking the invalid result run the test again with a new test strip If an error message appears on the display refer to the Troubleshooting Guide on page 31 If a HI or LO error appears on the display refer to HI and LO messages below 5 After inspection record valid results in your logbook with the date and time and compare them to the target goals set by your healthcare professional Refer to Suggested Testing Times and Target Goals on page 29 and your logbook for more details on your target blood glucose concentration goals 6 Remove and discard the test strip 23 eg tsa UO mg dL HI and LO Messages The meter can accurately measure blood glucose concentrations between 20 to 600 mg dL HI and LO messages indicate results outside of this range If HI appears on the display the measured concentration value is above 600 mg dL The test should be retaken to ensure that no mistake was made in the procedure If you are certain the meter is functioning properly and no mistakes were made in the procedure and your blood glucose is st
26. nfirm the code chip matches the test strip code and repeat the test If problem persists contact Clarity Customer Technical support If problem persists contact Meter electronics failure Clarity Customer Technical support Indicates an incorrect code chip was inserted in the meter Please make sure you use the Incorrect code chip Clarity Plus brand of test strips inserted in the meter with the Clarity Plus Blood Glucose Meter If problem persists contact Clarity Diagnostics Customer Technical support There is an error in transferring data to the PC Communications failure See the package insert included with the Data Management Kit for troubleshooting Damaged code chip or the code chip was removed during a test 32 Specifications Warranty Please complete the warranty card that came with this product and mail Feature Specification s it to Clarity Diagnostics to register your purchase Measurement Range 20 to 600 mg dL If the meter fails to work for any reason other than obvious abuse within the first five 5 years from purchase we will replace it with a new meter free of charge For your records also write the purchase date of Result Calibration Plasma equivalent your product here Date of purchase Note This warranty applies only to the meter in the original purchase Sample Fresh capillari ae Hous and does not apply to the battery supplied with the meter Minimum Sample Size 1 u
27. or diabetes healthcare professional before making any adjustments to your medication diet or activity routines Keep out of reach of children For help with any additional questions or issues please contact Customer Technical support at 1 877 485 7877 By following the instructions outlined in this User s Manual you will be able to use your Clarity Plus Blood Glucose Monitoring System to monitor your blood glucose and better manage your diabetes Table of Contents Getting States a ccccseic cccinccccecacerssetccceneesenssncessepeieeseasizeienseschacnncessanss 1 Component Descriptions sissi a 2 Clarity Plus Blood Glucose Meter cececeeceteeteeeeeees 3 Meter DIS NAY e aenea r E EE 4 Clarity Plus Blood Glucose Test Strips 5 Clarity Plus Glucose Control Solution cceeeeeeeeeeees 8 Installithe Battery siiceisicccccicetectsaseccstbcccesctusteesecenststeccctusteassreecasttecreeats 10 Meter Setup Before Testing ccccsseceseseeeeeseeeeeeseeeeeeeeeeeseseeeeeees 11 Step 1 Coding the Meter w c toec cece ria 11 Step 2 Adjusting the Meter Settings c cceeeeeeeeeeeeeees 12 Performing a Quality Control Test ccc ccceeeseeeseeneeeeeeeeneeeeneeeee 14 Testing Your Blood miii sa viecis tlie eirieeehsardhiiee 17 Step 1 Getting a Drop of Blood 00 cceeeeceeeeeeeeeeeeeeeeteeeeteeees 17 Step 2 Testing Blood GIUCOSE ceeeeceeeteeececteeeeeteeeeeeeeeeteaee
28. ot apply control solution to the test strip directly from the bottle Ifthe control solution sample does not fill the check window do not add a second drop Discard the test strip and start over with a new test strip 6 Once sufficient sample has been applied the meter display will count down from 9 to 1 and then display the result The control solution test results should be within the control range CTRL Low printed on the test strip vial This means that your blood glucose monitoring system is working properly and that you are performing the procedure correctly Test results are displayed in mg dL 15 7 Remove and discard the test strip The display should also show a pound sign indicating the test is a contro solution test This shows that the number will not be counted in the 7 14 and 30 day averages The pound sign will also be displayed when reviewing the results stored in memory If the result falls outside the indicated control range Confirm you are matching the correct range Low Control results should be matched to the Control Low range printed on the test strip vial Check the expiration date of the test strip and control solution Make sure that the test strip vial and control solution bottle have not been opened for more than 3 months Discard any test strips or control solution that has expired Confirm the temperature in which you are testing is between 15 and 40 C 59 104 F Make sure th
29. otion oils dirt or debris 21 Step 2 Testing Blood Glucose Note Insertion of a new test strip at any time except while in the data transfer mode will cause the meter to automatically enter the test mode Insert a test strip into the strip port contact bars end first and facing up to turn on the meter and display all the display segments If the audio option is on the meter will beep signaling the meter is turned on Make sure that the code number that appears on the display matches the code number CODE on the test strip vial If not make sure to locate and insert the code chip that came with the box of strips If the codes still do not match do not perform a test You will need a new package of test strips to perform a test The blinking test strip and blood drop icon will indicate that the test strip is inserted correctly and a drop of blood can be added Touch the blood sample to the sample tip at the end of the test strip If the audio option is turned on the meter will also beep to indicate the sample is sufficient and the measurement has started pO NOT Apply sample to the front or back of the test strip Smear the blood drop onto the test strip Press your finger against the test strip Apply a second drop of blood 22 4 The meter will count down from 9 to 1 and then display the measurement results The meter will also beep to indicate that measurement is complete To mar
30. rop Symbols These two symbols appear at the same time to tell you when to apply the sample Battery Symbol Warns when you should replace the battery CODE Appears with the code number of the Test Result Area test strips Indicates code number and test result Measurement Unit Only one unit will be displayed on your meter and cannot be adjusted MEM Shows a test result stored in memory Meter Use and Precautions The meter is pre set to display blood glucose concentration in milligrams per deciliter mg dL This unit of measure cannot be adjusted Do not get water or other liquids inside the meter Keep the strip port area clean Keep your meter dry and avoid exposing it to extremes in temperature or humidity Do not leave it in your car Do not drop the meter or get it wet If you do drop the meter or get it wet check the meter by running a quality control test Refer to Quality Control Test on page 14 for instructions Do not take the meter apart Taking the meter apart will void the warranty Refer to the Caring for Your Meter section on page 28 for details on cleaning the meter Keep the meter and all associated parts out of reach of children Note Follow proper precautions and all local regulations when disposing of the meter and used batteries Clarity Plus Blood Glucose Test Strips The Clarity Plus Blood Glucose Test Strips are thin strips with a chemical reagent whic
31. set the clock for either 12 or 24 hour mode Press the M button to switch between the two settings then press the S button to save your choice and start setting the year month and date 24H 2H 3 The year will appear at the top of the display Press the M button until the correct year is displayed Once you have selected the correct year press the S button to save your choice and start setting the month Press the M button until the correct month is displayed then press the S button to save your choice and start setting the date Press the M button until the correct date is displayed then press the S button to save your choice and start setting the time Year Month Date coos id 0 28 4 The hour will appear at the top of the display Adjust the hour with the M button until the correct hour is displayed Press the S button to save your choice and set the minutes Press the M button to change to the correct minute Press the S button to save your choice and move to set the audio feature 12 Hour Hour reo 0 fee OR Minutes Minutes 8 28 So 0 28 Sd OR 5 Audio Feature The meter comes with the meter audio feature enabled The meter will give one short beep when it is turned on after sufficient sample has been applied to the test strip and when the result is ready The meter will sound three short beeps to sound a w
32. t Internal calibration check any of these sources then retest If the problem persists contact Clarity Customer Technical support E 2 Test strip was removed Repeat the test and ensure test during the test strip remains in place Repeat test and apply sample after blood drop test strip icon appears y Test strip is contaminated Repeat test with a new test strip or used Repeat test and apply enough Insufficient sample sample to fill the test strip check window Sample was applied to the test strip too soon Temperature has exceeded the operating temperature Move to a cooler environment and repeat the test of the system 31 For help with any additional questions or issues Please contact Clarity Diagnostics Customer Technical support at 1 877 485 7877 Causes Solution Temperature is below the operating temperature of the system Battery is discharged but Test results will still be accurate has enough power to run but replace the battery as soon 10 more tests as possible Battery has discharged and meter does not allow more Replace the battery and repeat tests until replacement with the test a new battery Move to a warmer environment and repeat the test Insert the code chip that No code chip in the meter accompanied the box of test strips If the code chip is damaged use a new code chip with the correct code number and run the test If the chip is removed during a test co
33. ter battery replacement to ensure time is set correctly To set the meter clock see Meter Setup Before Testing on page 11 Caring for Your Clarity Plus Blood Glucose Monitoring System D Blood Glucose Meter Your Clarity Plus Blood Glucose Meter does not require special maintenance or cleaning A cloth dampened with water and a mild detergent solution can be used to wipe the outside of the meter Take care to avoid getting liquids dirt blood or control solution into the meter through the strip or data ports It is recommended that you store the meter in the carrying case after each use The Clarity Plus Blood Glucose Meter is a precision electronic instrument Please handle it with care E Lancing Device Use mild soap and warm water to clean with a soft cloth as required Carefully dry the device thoroughly Do not immerse the lancing device Please refer to the lancing device insert for more details pa oe 28 Suggested Testing Times Comparing Meter and Target Goals Tracking your blood glucose concentration through frequent testing is an important part of proper diabetes care Your diabetes health care professional will help you to decide the normal target range for your glucose levels They will also help you determine when and how often to test your blood glucose Some suggested times are When you wake up fasting level e Before breakfast 1 2 hours after breakfast Before lunch e 1 2 hours after lunch Be
34. tightly closed Do not transfer test strips to a new vial or any other container Replace the cap on the test strip vial immediately after removing a test strip A new vial of test strips may be used for 3 months after first being opened The opened expiration date is 3 months after the date the vial was first opened Write the opened expiration date on the vial label after opening Discard the vial 3 months after you first open it usage after this period may result in inaccurate readings Test Strip Precautions For in vitro diagnostic use Test strips are to be used only outside the body for testing purposes Do not use test strips that are torn bent or damaged in any way Do not reuse test strips Before running a blood glucose test make sure that the code number on the meter display matches the number shown on the test strip vial Keep the test strip vial away from children and animals Consult your physician or healthcare professional before making 7 any changes in your treatment plan based on your blood glucose test results See the test strip insert for more details Clarity Plus Glucose Control Solution The Clarity Plus Glucose Control Solution contains a known concentration of glucose It is used to confirm that your Clarity Plus Blood Glucose Meter and Test Strips are working together properly and that you are performing the test correctly It is important to run a quality control test regularly to make sure you
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