1150591402 OCP US User`s manu
Contents
1. On Call Plus Blood Glucose Monitoring System UIE ETU EN Distributed by CLIA walvedcom 11578 Sorrento Valley Road Suite 25 26 San Diego CA 92121 888 882 7739 2010 ACON Laboratories Inc OnCall Plus 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 ACON 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 On Call Plus Blood Glucose Monitoring System The On Call Plus Blood Glucose Monitoring System will give you accurate blood glucose results in just a few simple steps To ensure accurate results from your On Call 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 On Call Plus Blood Glucose Test Strips with the On Call Plus Blood Glucose Meter e 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 On Call Plus Blood Glucose Test Strips and Meter e For self testers consult your physician or di2. 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 Drop 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 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 e The meter is pre set to display blood glucose concentration in either millimoles per liter mmol L or milligrams per deciliter mg dL depending on which unit of measure is standard in your country This unit of measure cannot be adjusted The meter will be set to mg dL by default when sold in the United States 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
3. THI and LO MESSAGES anrcsin 24 Using the Meter Memory ccccsecceesseeeeeeseeeeeeeeeeeeneeeeeeeeneeneeeeeeneees 26 VIEWING Stored IRECOLS c sscrcccostencenssaccereisconcencennspcensgursendencenoans 26 Clearing the MEMORY sictscnsntoetintesar at ndessaeneamaavaciitess 27 Maintenance asusin seenasuiacrcanaivasiaatnaans cxdtadancisaains ime ncdendeneitaataasaarnns 28 Replacing the Battery soseste iE 28 Caring for Your On Call Plus Blood Glucose Monitoring System 0 eee eects 28 Suggested Testing Times and Target Goals cccessceeeeeeeeeeee 29 Comparing Meter and Laboratory Results ccccsseeesseeeeeseee 30 Troubleshooting Guile sissi 31 Specifications 222 2 i5 coe ne a ee a aaia ar ieaiaia 33 WaT EE E setcneepaancusedsoasuvsesssvaseessersscuaaucenees 34 INDO aA E EEEE EE EEEE 35 Getting Started Descriptions Before testing read the instructions carefully and learn about all the 1 Blood Glucose Meter Reads the test strips and displays the blood components of your On Call Plus Blood Glucose Monitoring System glucose concentration Depending on the On Calle 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 che
4. 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 EOR Correct Incorrect CODE 135 CTRL 1 4 5 6 7 mmol L 81 121 mgdL G133 114 Contents 10 Test Strips Lot 2990001 IMPORTANT Before using these test strips Carefully read the Package Insert andor EXP 2008 01 a User s Manual for your meter ACON Laboratories Inc 10125 Mesa Rim Road San Diego CA92121 USA 14 9 19 8 mmol L Store at 5086F Customer Support 1 800 838 9502 268 356 mg dL Each package of test strips is printed with a code number CODE lot number LOT unopened expiration date g4 and control range CTRL1 and CTRL 2 E Storage and Handling Please review the following storage and handling instructions Store test strips in a cool dry place at room temperature 59 86 F 15 30 C 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 Repl
5. 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 e 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 On Call Plus Glucose Test Strips The On Call Plus Blood Glucose Test Strips are thin strips with a chemical reagent which work with the On Call 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 as o 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 gt e Correct
6. glucose monitoring system and testing procedures This small guide can be kept in your carrying case a Sterile Lancet Control Solution 11 Quick Start Guide A short set of instructions to get you started testing with your new system 12 Logbook Allows users to record their blood glucose data and get a better picture of their broader trends 13 Warranty Card Should be completed and returned to the warranty center to qualify for the 5 year meter warranty Carrying Case 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 CH Code Chip Code Chip Slot M Button M S 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
7. 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 Fasting and Before Meals 70 100 3 9 5 6 2 Hours after Meals Less than 140 Less than 7 8 Talk to your diabetes healthcare professional to set your own daily target ranges Waking up Fasting level Before meals 2 hours after meals Bedtime 2 AM to 3 AM Other Note 1 mmol L 18 mg dL 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 2010 29 Your On Calle 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 This is expected but the difference under normal operating conditions should be no greater than 20 Users should make accurate comparisons periodically between meters and laboratory results Fol
8. mgg enter the test mode The display will show the TERNA date and time and the strip icon with the blood 7 sample icon blinking The code number will be displayed in the center of the screen Make sure that the code number that appears on the display matches the code number CODE CODE on the test strip vial or on the foil pouch 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 4 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 out a second small drop on a clean nonabsorbent surface 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 not apply control solution to the test strip directly from the bottle If the c
9. setup mode The meter will automatically enter the setup mode when turned on for the first time by any method 2 First 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 CHH icH 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 cogs il f 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 eB ik e8 tt OR Minutes Minutes 28 Sa 0 28 iS OR 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 applie
10. the side Control Solution Precautions facing Hpi 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 59 and 104 F 15 40 C The control ranges shown on the test strip vial or on the foil 3 pouch are not recommended ranges for your blood glucose f level Your personal 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 Please contact Customer Support at 1 800 838 9502 for more information on obtaining the control solution kit See the control solution insert for more details Meter Setup Before Testing 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 or on the foil pouch and the number printed on the code chip You can easily fi
11. 11 Meter Use and Precautions 5 S BUMON aiiis 3 Set the CIOCK cece 12 Specifications 33 35 Procedure Precautions and Limitations 24 Testing Your Blood 17 Quality Control Test Control Solution nd How to RUM ci scciss0 cece cectsesies 14 Results Blood Glucose 23 Control Solution 15 Meter vs Lab Results 30 Target Goals 29 Unit of Measure 15 29 Suggested Testing Times 29 Test Strip cece 5 COG O EEEE 6 Expiration 7 Precautions cc cccsececccceseeetaits 8 Testing Your Blood 00 Get a Drop of Blood Test Blood Glucose Troubleshooting ceeeeee 31 Viewing Stored Record 26 Warranty sivcicccedeetecttacs 2 34
12. CTRL 2 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 please contact Customer Support at 1 800 838 9502 for help Please contact Customer Support at 1 800 838 9502 for more information on obtaining the On Call Plus control solution kit which contains Control Solution 1 and Control Solution 2 16 Testing Your Blood The following steps show how to use the meter test strips lancing device and sterile lancets together to measure your blood glucose concentration Step d Getting The On Calle 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 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 i Clear Cap Cocking Barrel Lancet Holder esi ieeting on forcaim Sterile Lancet and palm i mats am prolly Safety Tab
13. Release Button Puncture Depth Lancing Device Settings Cover 17 B 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 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 18 produces an adequate drop of blood E Forearm or Palm at the base of the thumb Testing Adjustment 1and 2 for delicate skin 3 for normal skin 4and5 for calloused or thick skin Note Greater pressure of the lancing device 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
14. 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 8 28 So og mg dL ghigand EO Messages The meter can accurately measure blood glucose concentrations between 1 1 to 33 3 mmol L 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 33 3 mmol L 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 still 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 1 1 mmol L 20 mg dL The test should be
15. abetes healthcare professional before making any adjustments to your medication diet or activity routines Keep out of reach of children e For help with any additional questions or issues please contact Customer Support at 1 800 838 9502 By following the instructions outlined in this User s Manual you will be able to use your On Call Plus Blood Glucose Monitoring System to monitor your blood glucose and better manage your diabetes Table of Contents Getting State wcsezsvcsssecsvcereewcateevecascescandenveneanedesseneedeceusndeueciseeserveseerse 1 Component DESCMPLONS srair iai i 2 On Call Plus Blood Glucose Meter c ccccceseeeeeseteeeeeees 3 Meter DISPIAY cteccccenceeyccncetecvescesiensemecicarcee iae 4 On Call Plus Blood Glucose Test Strips escceeeseseeeeeteees 5 On Call Plus Glucose Control Solution cceeseceeeseeeeees 8 Install the Battery siizicsccacciesaceternivczivateesnasascatasereseoden tees cariomandselewnas 10 Meter Setup Before Testing ccsscsssesssssssesssesseesssessseesneesesenees 11 Step T Coding the Meter i cctbecassisteneeeeress cevseestestesecatinenncs 11 Step 2 Adjusting the Meter Settings Performing a Quality Control Test we 14 Testing Your BIOOG siscisies sostsincses nsces eps scceseeims fuer A 17 Step 1 Getting a Drop Of BlOOd ssiscticcssciscavaneesscsnsiecssize sean 17 step 2 Testing Blood GIUCOSE snini 22
16. ace 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 2008 01 means January 2008 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 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 E Special Instructions for Test Strip in Foil Pouch Tear the pouch carefully starting from the tear gap Avoid damaging or bending the test strip Use test strip immediately after removing it from the pouch Test Strip Precautions For in vitro diagnostic use Test strip
17. d 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 59 and 104 F 15 40 C Make sure that the test strip vial and control solution bottle have been tightly capped Make sure code number on the strip vial label or on the foil pouch matches the code number 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 or on the foil pouch your meter may be defective Please contact Customer Support at 1 800 838 9502 for help Two levels of control solution are available labeled Control Solution 1 and Control Solution 2 Control Solution 1 is sufficient for most all self testing needs If you think your meter or strips may not be working correctly you may also want to do a level 2 test The ranges for both CTRL 1 and CTRL 2 are displayed on the test strip vial or on the foil pouch Simply repeat step 4 through 6 using Control Solution 2 For confirmation of results Control Solution 1 tests should fall within the CTRL 1 range and Control Solution 2 tests should fall within the
18. d to the test strip and when the result is ready The meter will sound three short beeps to sound a warning 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 Aud c0 R ud oa MECC x M urr un 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 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 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 E G o m PAA mmol L mg dL MEM CODE B 88 ave dB BB ew Check the display to confirm that all the display segments turn on see display illustration above Following this display check the system will 0 28
19. draw blood from these 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 Rotation of sites is recommended Repeated punctures in the same spot can make your fingers sore and callused 19 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 You should talk to your healthcare professional before doing forearm or plam glucose testing When blood levels are changing rapidly such as a
20. er share lancets or the lancing device with other people to prevent possible infections 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 lotion oils dirt or debris For AST testing if current lancet is not obtaining enough blood due to skin or other conditions please contact Customer Support at 1 800 838 9502 for information on different lancet options 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 DO 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 Specimen collection and preparation by healthcare professionals Please refer to test strip insert if applicable 21 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 mark 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
21. fter 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 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 2 Screw the clear cap onto the lancing device 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 and 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 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 2 Testing Blood Glucose Note Insertion of a new test strip at any time except while in the data transfer mode detailed on page 28 will cause the meter to automatically ente
22. hold both the L MEM M and S buttons for two seconds 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 meter The battery carrier should be easily opened with you finger 3 Remove and discard the old battery Replace f it with a new CR 2032 3 0V coin cell battery Make sure it is aligned with the side facing up in the battery carrier 4 Close the battery carrier and make sure that it snaps shut 5 Recheck and reset the clock setting as necessary after battery replacement to ensure time is set correctly To set the meter clock see Meter Setup Before Testing on page 11 Blood Glucose ED Blood Glucose Meter Your On Call Plus Blood Glucose Meter does not require s
23. low the guidelines below 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 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 Battery may be damaged Temperature is below the Move to a warmer environment tests until replacement with a new battery mn j LUE ap ae soe peratire and repeat the test 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 E 6 meter does not allow more Replace the battery and repeat the test No code chip in the meter Insert the code chip that accompanied the box of
24. mical reagent system used with the meter to measure glucose concentration 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 Call Plus The packaged lancing device has multiple depth settings allowing Monessa eet e users to adjust the depth of the puncture and minimize discomfort Lenin m 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 each blood draw and discarded after use 7 Control Solution Verifies the proper operation of the blood glucose monitoring system by checking the test strips and meter against a precalibrated control solution Control Solution 1 is all you need Code Chip most of the time Control Solution 2 is also available if you want to do a level 2 test The two levels of control solution Control 1 and Control 2 are available in the On Call Plus Glucose Control a i ARA Solution package which is sold separately i m 8 Carrying Case Provides portability for blood glucose testing Lancing Device Clear Cap wherever you go Blood Glucose Meter 9 User s Manual Provides detailed instructions on using the blood glucose monitoring system 10 Quick Reference Guide Provides a brief overview of the blood
25. nd a code chip in your starter kit box This code chip is used with the test strip packed in your carrying case 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 or on the foil pouch 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 or foil pouch of strips with which it was packaged please contact Customer Support at 1 800 838 9502 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 CODE 135 135 Note If a test strip is inserted and no strip code is stored in memory the display will flash CODE 11 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
26. nd shown to work properly up to 8 516 ft 2 595 meters Severely ill persons should not run the glucose test with the On Call 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 not been tested and are not recommended for testing with On Call Plus Blood Glucose Monitoring System Dispose of blood samples and materials carefully Treat all blood samples as if they are infectious materials Follow proper precautions when disposing of materials 25 Using the Meter Memory The meter automatically stores up to 300 test records Each record includes the test result time and date If there are already 300 records in memory the oldest record will be erased to make room for a new one The meter will also calculate the average values of records from the last 7 14 and 30 days To view stored records 1 Press the M button to turn the meter on and enter memory mode The most recent value and the word MEM will appear on the display Records eB iso HG mg dL If you are using the meter for the very first time the meter 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
27. 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 AVG 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 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 AVG will also appear in the display we Lin ig mg dL 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 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 l E D 2 To clear the memory press and
28. ontrol 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 CTRL1 printed on the test strip vial or on the foil pouch This means that your blood glucose monitoring system is working properly and that you are performing the procedure correctly 8 26 Sa g Dee ipso g q 81 121 mgidL m 81 121 mgd Test results are displayed either in mmol L or mg dL depending on the unit of measure most common in your country The meter will be set to mg dL by default when sold in the United States 15 7 Remove and discard the test strip The display should also show a pound sign indicating the test is a control 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 Control Solution 1 results should be matched to the CTRL 1 range printed on the test strip vial or on the foil pouch e Check the expiration date of the test strip and control solution Make sure that the test strip vial an
29. ower 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 either millimoles per liter mmol L or milligrams per deciliter mg dL depending on the standard of your country The meter will be set to mg dL by default when sold in the United States Glucose Units of Measure 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 41 113 F 5 45 C Operating Relative Humidity 20 90 non condensing Hematocrit Range 30 55 Averaging Resulfts 00 26 Battery Replacing the 28 Carrying Case 1 Clearing the Memory 27 Data POterio vein it viens 3 Date Format 7 9 Guidelines ccsecesceseeseeeeees i Hematocrit ccccceeeeeee 24 33 Install the Battery 10 Lancing Device 1 17 28 Lancets 1 17 LOQDOOK cesseceseeeeeeeeeeeeee 2 29 Maintenance and Disposal 5 28 Measure Unit of 4 15 IMG teh s 20 2ccecesccccssicceccescepecieestzeese 3 Audio feature 13 GleaninG eiiean 28 Code Chipisacsceceni eens 2 Displays ioiii 4 Error Messages HI and LO Messages 24 M BURON eitis 3 MEMON ciecnrorisasirisnresana 26 Meter Code cececeeeeeeeees 11 Meter Setup eeseeseeees
30. pecial 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 On Call 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 28 Suggested Testing Times and Target Goals Comparing Meter and Laboratory Results 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 Before breakfast 1 2 hours after breakfast Before lunch 1 2 hours after lunch Before or after exercise Before dinner 1 2 hours after dinner Before bedtime After a snack At2or3A if taking insulin You may need to test more often whenever You add or adjust your medication for diabetes You think your blood glucose levels
31. r the test mode di has formed 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 E Disposal of the Lancet the audio option is on the meter will beep signaling the meter is turned on 1 Unscrew the lancing device cover Place the safety tab of the lancet on a hard surface and Make sure that the code number that carefully insert the lancet needle into the appears on the display matches the code safety tab number CODE on the test strip vial or on 0 28 a5 the foil pouch If not make sure to locate ae and insert the code chip that came with the gpm box of strips If the codes still do not match do not perform a test You will need a new 2 Press the release button to make sure that package of test strips to perform a test as the lancet is in the extended position Pull the lancet straight out of the lancet holder and SODE discard it in an appropriate container Place 2 The blinking test strip and blood drop icon the lancing device cover back on the lancing will indicate that the test strip is inserted device correctly and a drop of blood can be added Lancet Precautions Do not use the lancet if the safety tab is missing or loose when 3 Touch the blood sample to the sample tip at 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 Nev
32. 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 id 28 2 50 Hi 0 28 1 50 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 Abnormally high levels of Vitamin C ascorbic acid Acetaminophen Uric Acid L Dopa Tolazamide or other reducing substances will produce falsely high blood glucose measurements Fatty substances Triglycerides up to 3 000 mg dL or Cholesterol up to 500 mg dL have no major effect on blood glucose test results The On Call Plus Blood Glucose Monitoring System has been tested a
33. s 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 e 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 or on the pouch Keep the test strip vial or the foil pouch away from children and animals e Consult your physician or healthcare professional before making any changes in your treatment plan based on your blood glucose test results e Not intended for the diagnosis of or screening for diabetes mellitus Not for use on neonates When testing alternative sites test when in steady state only such as before eating before taking medication before exercising or 2 hours after eating See the test strip insert for more details T contains a known concentration of glucose It is used to confirm that your On Calle 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 are getting correct results You should run a quality control test On Glucose Control Solution he On Call Plus Glucose Control Solution Control Solution i n de Control Before you first use your meter to familiarize yourself with its operation ae Before using a new box of test strips When you suspect that the meter or
34. sts contact customer 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 Sample was applied to the pak E J test strip too soon after blood drop test strip icon appears E 4 Test strip is contaminated Repeat test with a new test strip or used Repeat test and apply enough E 5 Insufficient sample sample to fill the test strip check window Temperature has exceeded F HEE the operating temperature Move to a cooler environment and repeat the test 31 For help with any additional questions or issues please contact Customer Support at 1 800 838 9502 32 Specifications Warranty Feature Specification Please complete the warranty card that came with this product and mail it to the following address Measurement Range 20 to 600 mg dL On Call Plus Warranty Center 10125 Mesa Rim Road Result Calibration Plasma equivalent San Diego CA 92121 2915 USA Sample Fresh capillary whole blood 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 Minimum Sample Size 1 uL your product here Date of purchase test tine 10 seconds Note This warranty applies only to the meter in the original purchase and does not apply to the battery supplied with the meter P
35. test strips Damaged code chip or the code chip was removed during a test 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 confirm the code chip matches the test strip code and repeat the test E 8 E 9 Meter electronics failure Incorrect code chip inserted in the meter If the problem persists contact customer support Indicates an incorrect code chip was inserted in the meter Please make sure you use the On Call Plus brand of test strips with the On Call Plus Blood Glucose Meter If the problem persists contact customer support Communications failure There is an error in transferring data to the PC See the package insert included with the Data Management Kit for troubleshooting of the system or not be charged Replace battery Meter If meter has been exposed to fails to or stored in cold conditions turn on Meter is too cold wait 30 minutes to allow meter to reach room temperature then repeat test Remove battery for 30 seconds and then put battery back and E E Power On self check error turn meter on again If problem persists contact customer support If a cell phone radio frequency source or a high power electrical ts source is nearby place more E I ia calibration check distance between the meter and 9 any of these sources then retest If the problem persi
36. 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 b diagnostic use onl b 86 F Refer to Quality Control Test on page 14 for instructions on running a quality control test P lease review the following storage and handling instructions 8 a Storage and Handling Install the Battery Store the control solution at room temperature 59 86 F 15 30 C Do not refrigerate or freeze e 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 The expiration date is printed in Year Month format 2008 01 means January 2008 e 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 label Battery may not be preinstalled in the meter One CR 2032 3 0V coin cell battery is required Please find the battery in your carrying case and install it according to following steps 1 Pull the battery carrier on the left side of the meter The battery carrier should be easily opened with your finger 2 Place a new CR 2032 3 0V coin cell battery Make sure it is aligned with
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