Ultra Blood Glucose Monitoring System
Contents
1. 36 i aT ee ee ee eee rd 20 Tancet Disposal 2 3 oet thee pe ERES OP DOO n d 29 LifeScan Interface Cable ies eor repr canes esi eR ERE dae 34 M Buton uisu e quoc rd ien e pq np a DURO d Rr en p e p EN 5 Memory USING iccirco d Wey b n b ja SOROR UA DI CDU CV RR 32 Messages Special ssi 453 4 444 044 4454 0 44 i wha ene p ER haters 46 Meter Display ive ser eer eek hr vad la UENIRE ER FRE 6 Meter Display Checking i once mee e eb ee ree e 414 5405554 10 Meter Maintenance coiere eto ete Yet Ra ERR RC e P Mendes 42 Meter Specifications 14 4 44422 ae cas Loves S n ER POP ODD 56 OneTouch Ultra Blood Glucose Meter LL SK KK KK 5 OneTouch Ultra Blood Glucose Monitoring System 0008 4 OneTouch Ultra Control Solution se n 4 gt 4 s wal eee Eni 15 OneTouch Ultra Test SDS ore itera ht b ab eee 8 i vM ET 10 own MCN MM kote bile Ree Ao der k dk Xelka N ara AMANA 9 OneTouch UltraSoft Sampler Cleaning LL 42 OneTouch UltraSoft Sampler Preparing LL 19 OneTouch UltraSoft Sampler Using L LSS SK 20 Plasma CalibEalion Jesse trente eor RENE bbb D Md edo is iv Problems SOWING s s3 esee e WE A rela eh ert rer E 46 Setting the Time and Date 14 3 lt i lt 4 J485 et CE eret OE ed 38 Step by Step Test Procedure sisis i ak ayy ek el al k kl aa ka orisi kal 26 System2. User Manual to initiate the data transfer command If the command is not received within two minutes the meter will turn itself off Pressing the M button will also turn the meter off To learn more about OneTouch Diabetes Management Software or to obtain a LifeScan Interface Cable separately contact the LifeScan Data Management Line at 1 800 382 7226 or visit us at www LifeScan com 35 36 Comparing Meter and Laboratory Results OneTouch Ultra Meter test results and laboratory test results are both expressed in plasma equivalent units However your meter result may differ somewhat from your laboratory result due to normal variation Meter results can be affected by factors and conditions that do not affect laboratory results in the same way Your OneTouch Ultra Meter glucose value should agree with a laboratory measurement within 20 most of the time under normal conditions A result within that range is considered accurate when testing with the OneTouch Ultra Meter However results can differ by more than 20 in some situations See the OneTouch Ultra Test Strip package insert for typical accuracy and precision data and for important information on Limitations of Procedure To make an accurate comparison between meter and laboratory results follow these guidelines Before going to tbe lab gt Perform a control solution test to make sure the meter is working properly P It is best to fast for at lea
3. Checking the i e cat oo eo 40a tet di d n 13 TES PONE i ab nay n eta ya dia hee te PR aUi santos 34 Test Procedure Step by Step i i ere crm eer eter dakako 26 Test Strip Information Important isses 9 Test Strips OneTouch Ultra ope eres mete ber e ae 8 59 Notes Glucose Ranges Times of Day for People Without Diabetes mg dL Your Target Ranges mg dL Before breakfast or dinner 1 hour 2 hours Between Source Krall L P and Beaser R S Joslin Diabetes Manual Philadelphia Lea and Febiger 1989 138 Meter Serial No Important phone numbers LifeScan Customer Services 24 hours a day 7 days a week English 1 800 227 8862 Espafiol 1 800 381 7226 Healthcare Professional Pharmacist Diabetes Educator Other LifeScan Customer Services toll free numbers 24 hours a day 7 days a week U S A English 1 800 227 8862 Espafiol 1 800 381 7226 Visit the LifeScan Web site www LifeScan com OLifeScan Inc 2002 Milpitas CA 95035 2 03 Patent Nos 5 708 247 and 5 951 836 AW 06017505A
4. and release the C button until the correct n month appears To move faster hold the C button ZIN down With the correct month on the display press the M button and the day segment will start flashing E STEP 6 Set the Day Press and release the C button until the correct day appears To move faster hold the C button down With the correct day on the display press the M button and the current unit of measure will start flashing NOTE The 14 and 30 day averages in the meter memory are calcu lated from results obtained during the 14 and 30 calendar days pre ceding the current date and time settings When the date and time are changed the averages may change 40 41 42 Caring for Your OneTouch Ultra System Meter Your OneTouch Ultra Meter does not require special maintenance or cleaning Take care to avoid getting dirt dust blood control solution or liquids inside the meter through the test port or data port LifeScan recommends that you store the meter in its carrying case after each use A cloth dampened with water and mild detergent can be used to wipe down the outside of the meter Your OneTouch Ultra Meter is a precision instrument Please handle it with care OneTouch UltraSoft Sampler Clean the sampler and caps with soap and water To disinfect the sampler prepare a disinfectant solution of one part household bleach to 10 parts water Dampen a cloth with this soluti
5. pL in volume actual size to fill the confirmation window When the symbol appears on the display touch and hold the drop of blood to the narrow channel in the top edge of the test strip DO NOT Apply sample to the front or back of the test strip gt Push your finger against the test strip D Apply a smeared sample 27 Hold the blood drop to the top edge of the test strip until the confirmation window is full before the meter begins to count down If the confirmation window does not fill completely before the meter begins to count down do not add more blood to the test strip discard the test strip and retest If you have trouble filling the test strip contact LifeScan Customer Services for assistance If the confirmation window is not full you may get an 5 message or an inaccurate test result Good Sample Sample Too Small NOTE If you do not apply a blood sample within two minutes after the symbol appears the meter will turn itself off You must remove the test strip and insert it back into the meter to restart the test procedure STEP 3 Accurate Results in Just 5 Seconds Your blood glucose test result will appear after the meter counts down from 5 to Blood glucose test results are automatically stored in the meter memory You may also record them in the logbook provided with your system Turn the meter off by removing the test strip Dispose of used test stri
6. to problem with the test strip pages 27 28 for informa Possible causes are test strip tion on sample applica damage or an incompletely tion filled confirmation window The zz sign appears on Test results will still be the display with the unit of accurate but replace the measure The power is get battery as soon as possible ting low You can complete about 50 more tests from the time this symbol first appears mg dL The 2 sign appears on Replace the battery at the display by itself The once The meter will power is too low to perform not operate a test 53 MESSAGE WHAT IT MEANS has lost power and entered the setting mode The meter has detected that the temperature is below the system operating range Do not perform a test until the meter and test strips reach a temperature within the operating range of 43 111 F 6 44 C The meter has detected that temperature is above the system operating range Do not perform a test until the meter and test strips reach a temperature within the operating range of 43 111 F 6 44 C 54 ACTION Flashing time means the meter You must reset the time time format and date See Setting the Meter pages 38 41 Repeat the test after the meter and test strips have reached a temperature within the operating range Repeat the test after the meter and test strips have reached a temperature within the operating range If the meter does not display
7. vial label It is very important that you do this simple check routinely to make sure you get an accurate result hral u l s rm Before you use the OneTouch Ultra Meter to test your blood for the first time practice the procedure using control solution When you can do three tests in a row that are within the range you are ready to test your blood 13 14 Important Control Solution Test Information Use only OneTouch Ultra Control Solution Check the expiration date on the control solution vial Record the discard date date opened plus three months on the vial label Do not use after expiration or discard date whichever comes first Control solution meter and test strips should be at room temperature 68 777F 20 25 C before testing D Shake the vial discard the first drop of control solution and wipe off the tip to ensure a good sample and an accurate result gt Store control solution tightly closed at temperatures below 86 F 30 C Do not refrigerate CAUTION The control solution range printed on the test strip vial is for OneTouch Ultra Control Solution only It is not a recommended range for your blood glucose level When to do a control solution test Once a week D When you open a new vial of test strips gt Whenever you suspect that the meter or test strips are not working properly If your blood glucose test results are not consistent with how you feel D After
8. 2 Massage the Fingertip Massaging the fingertip gently will help you obtain a round drop of blood Do not squeeze excessively on the puncture site The blood sample must be at least one microliter 1 pl in volume amp actual size or you may get an E 5 message see page 53 or an inac curate test result Do not smear the blood sam ple Proceed with your blood glucose test Arm Blood Sampling The arm has fewer nerve endings than the fingertip so you may find that obtaining a blood sample from the arm may be much less painful than using the fingertip The technique for arm sampling is different from fingertip sampling Also there are differences between arm samples and fingertip samples that you should understand Please read the important information on page 25 carefully STEP 1 Install the UltraClear Cap To aid in obtaining a blood sample from the arm replace the regular sampler cap P with the UltraClear cap If necessary set the sampler for a deeper puncture STEP 2 Choose the Puncture Site Select a soft fleshy area on your arm that is clean and dry away from bone and free of visible veins and hair 23 24 STEP 3 Massage the Area To increase blood flow to the puncture site massage the area gently For individuals who experience difficulty in getting sufficient blood for a test rubbing the area more vig orously or the brief application of heat may be helpful STEP 4 Positio
9. E You may have a very high blood glucose level exceed ing 600 mg dL mg dL ygan You may have a very low blood glucose level lower than 20 mg dL mg dL 0 30 m5 n A blood glucose test result stored in the memory ILI mg dL id 30 15 ACTION You should recheck your glucose level and if H call your healthcare professional immediately Treat this condition immediately according to your healthcare professional s recom mendations None required 49 MESSAGE WHAT IT MEANS ACTION A control solution test None reguired result stored in the memory There is no test result None reguired stored in this place in the memory Average of the last 14 days No action required 7 B means that 64 tests I were performed within the L period The 30 day average yea Bs appears with a 30 50 MESSAGE WHAT IT MEANS Error message that indicates that there is a problem with the meter Error message could be caused either by a used test strip or a problem with the meter Error message that indicates that the blood or control solution sample was applied before the amp symbol appeared on the display ACTION Do not use the meter Contact LifeScan Customer Services at 1 800 227 8862 for a replacement meter Repeat the test with a new test strip Refer to pages 8 9 for test strip information If the error message persists contact LifeScan Cust
10. ONE TOUCH The Comfort of control x ae eR an m k f i k 1 Du r io m Li kl i j A pei Owner eee a OneTouch Ultra System Owner s Booklet Dear OneTouch Ultra System Owner Thank you for selecting the OneTouch Ultra System This booklet includes everything you need to know about your new blood glucose monitoring system so please take a moment to read it carefully before you begin testing In selecting the OneTouch Ultra System you have chosen one of the best blood glucose monitoring sys tems available Because blood glucose monitoring plays such an important role in diabetes control this system is specifically designed to make testing easier and less painful You now have the freedom to test on your arm as well as your fingertips you ll find it s less painful to test on your arm because it has fewer nerve endings than your fingers What s more the OneTouch Ultra is lightweight needs only a tiny drop of blood displays accurate results in just five seconds and stores up to 150 blood glucose and control solution test results Your OneTouch Ultra System provides you with accurate plasma calibrated test results This feature makes it easier for you and your doctor to compare your meter results with laboratory results If you ve been using another type of meter you may notice that your results with the OneTouch Ultra System are approximately 12 higher
11. To prevent or delay diabetes complications it s important to keep your blood glucose at a normal level Blood glucose levels change according to food intake exercise and medication The key to feeling good is controlling your levels and minimizing the effects of high blood sugar by testing your blood glucose regularly As the maker of OneTouch brand blood glucose monitoring systems LifeScan is dedicated to your health and satisfaction You can count on 24 hour customer service by highly trained professionals who are ready to answer your questions about meter operation self monitoring and diabetes in general LifeScan com offering online access to information about our products and services as well as diabetes care Our OneTouch Gold program providing members with an exclusive toll free customer service line a free subscription to the OneTouch Newsletter and more see the brochure inside your OneTouch Ultra package for details We have included a warranty registration card with your system Please complete and return it promptly to receive a special gift of your choice as well as important information regarding your OneTouch pro duct You may also complete product registration online at www OneTouchWarranty com We care about what you think and want to keep you informed about the latest on better living for people with diabetes If you have any questions about your new OneTouch Ultra System please call LifeScan Customer Service
12. a message after inserting a test strip Need battery Replace the battery No battery or battery Check that the battery is incorrectly installed correctly installed with the positive side up Test strip inserted incor Insert the test strip correctly rectly or incompletely with the contact bars end first and facing up Push it in until it will go no further Defective meter or test strip Call 1 800 227 8862 If the test does not start after applying the sample POSSIBLE CAUSE WHAT TO DO Insufficient blood sample Repeat the test with a new test strip and a larger sample Defective test strip Repeat the test with a new test strip Sample applied after auto Repeat the test with a new test matic shutoff two minutes after last user action strip apply sample only when the appears on the display Defective meter Call 1 800 227 8862 55 56 Specifications Result Range 20 to 600 mg dL Calibration Plasma equivalent Sample Fresh capillary whole blood Sample Size Minimum 1 microliter Test Time 5 seconds Assay Method Glucose oxidase biosensor Power Source One replaceable 3 0 V 2032 or equivalent lithium battery Battery Life 1 000 tests or about one year at three tests per day Glucose Units mg dL Memory 150 blood glucose and control solution tests Automatic Shutoff Two minutes after last user action Size 3 12 x 2 25 x 85 Approximate Weight 1 5 ounces with ba
13. ayed for three seconds The first time you use the meter three dashes will appear meaning that there PER is no code stored in the memory If three dashes appear any other time see page 46 of Code Display Messages and Problem Solving Guide 1 2 STEP 2 Match the Code Numbers Compare the code number on the meter display with the code number on the test strip vial If the two code numbers match you may begin testing If they do not match follow Step 3 11 STEP 3 Code the Meter Press the C button to select the correct code Each time you press and release the C button the number will increase by one To move more quickly press and hold the C button After selecting the correct code number it will flash for three seconds and then appear solid for three seconds Then the symbol will appear with the unit of measure indicating that the OneTouch Ultra System is ready for testing Ouch Ultra Checking the System NOTE Refer to additional information in the OneTouch Ultra Control Solution package OneTouch Ultra Control Solution is used to check that the meter and the test strips are working together as a system and that you are performing the test correctly OneTouch Ultra Control Solution contains a measured amount of glucose that reacts with OneTouch Ultra Test Strips Compare your control solution test results with the range printed on the test strip
14. ck if your meter has not been coded If this message appears at any time after the first time the meter was coded the code number has been lost The test results stored in the meter memory may be out of order r2 ACTION If segments are missing contact LifeScan Customer Services for further action Missing segments can lead to misinterpretation of test results 1 See Coding the Meter pages 10 12 2 Do not rely on the 14 and 30 day averages It is important to call LifeScan Customer Services for assistance m a n m WHAT IT MEANS This is the code number stored in the meter The system is ready to accept a blood sample The system is ready to accept a control solution test sample Five second countdown The meter is calculating the result After the countdown the meter will display the test result ACTION Make sure that this code number matches the code number on the vial of the test strips you are using You may now apply the blood sample You may now apply the control solution None required 47 MESSAGE WHAT IT MEANS ACTION A blood glucose test result None required I r in mg dL LI mg dL 30 15 ketones A blood glucose test result Follow the instructions 1 d with a suggestion to check of your healthcare U your ketone levels professional regarding c ketone testing mg dL 30 tugom MESSAGE WHAT IT MEANS ERE
15. d to enter the setting mode and reset To set the time you must enter the setting mode Start with the meter off Then press and hold the M button for three seconds The meter is now in the setting mode STEP 1 Set the Hour With the hour setting flashing press and release l the C button to advance one hour To move faster leul AM hold the C button down With the correct hour on x the display press the M button and the minutes setting will start flashing Before setting tbe date you must have first set the time STEP 2 Set the Minutes Press and release the C button to advance one minute To move faster hold the C button down With the correct minute on the display press the M IN button and the AM PM 12 hour format setting will start flashing STEP 3 Set the Time Format I The meter can display the time in either an AM PM AM 12 hour format or a 24 00 24 hour format The r n AM PM format is preset in the meter If you wish to display the time in the 24 00 format press the C button With the pre ferred time format on the display press the M button and the year set ting will start flashing STEP 4 Set the Year Press and release the C button to advance one year To move faster hold the C button down With the correct year on the display press the M button and the date will appear on the display with the month segment flashing 39 a STEP 5 Set the Month 4l Press
16. dropping the meter How to do a control solution test STEP 1 Insert Test Strip Insert a test strip contact bars end first and facing up into the test port Push it all the way in until it will go no further The meter will turn on and the display check will appear briefly Then the code number will appear followed by the amp symbol and unit of measure Check that the unit of measure is set correctly Be sure the meter and test strip codes match If they do not code the meter correctly See pages 10 12 Press the C button to mark the test as a con trol solution test in the meter memory ctl will appear on the display If you decide not to do a control solution test press the C button again to remove ctl from the display 15 STEP 2 Apply Control Solution To ensure an accurate result D Shake the vial well D Discard the first drop Wipe the dispenser tip Hold the drop to the narrow channel in the top edge of the test strip When the confirma tion window is full the meter will begin to count down from 5 to second 16 STEP 3 Result Appears in 5 Seconds Compare the control solu tion test result with the range printed on the test strip vial The result should fall within this range NOTE Mark all control solution tests with ctl to distinguish them from blood glucose tests in the meter memory Marked control solution tests will not be included in your averages Compar
17. f the battery is facing up STEP 3 Place the cover Place the cover over the battery compartment a Push down until you hear the tab click into ETT place Hie NOTE D Replacing the battery does not affect previous test results stored in memory However the time and date settings may need to be updated D After replacing the battery turn the meter on by inserting a test strip or pressing the M button If the meter is in setting mode confirm that the time time format and date are set correctly If they are not use the M and C buttons to reset the meter before testing See Setting the Meter pages 38 41 45 46 Display Messages and Problem Solving Guide Following is a summary of all display messages These messages help to identify certain problems but do not appear in all cases when a problem has occurred Improper use may cause an inaccurate result without pro ducing an error message or a symbol In the event of a problem refer to the information under ACTION Assistance is available from LifeScan Customer Services 24 hours a day seven days a week MESSAGE WHAT IT MEANS Display check Appears whenever the meter is turned on To verify that all segments are present on the display press and hold the C button Compare the meter display with page 10 code ctl ketones mem LI IL LI LILI SET mmol L mg dL AM PM 8 88 ava BE 1 This message appears immediately after the display che
18. h laboratory tests If you have been using another type of meter one that provides whole blood results you may notice that your test results with the OneTouch Ultra System are about 12 higher mg dL milligrams deciliter no decimal point U The OneTouch Ultra Blood Glucose Monitoring System consists of the OneTouch Ultra Blood Glucose Meter OneTouch Ultra Test Strips may be sold separately and the OneTouch Ultra Control Solution These products have been designed tested and proven to work together to produce accurate blood glucose results Use no other test strips or control solution with your meter The OneTouch Ultra System is intended for use outside the body in vitro diagnostic use It should be used only for testing fresh capillary whole blood samples for glucose sugar It should not be used for the diag nosis of diabetes or for testing newborns Before using any product to Cu your blood glucose read all instructions and practice the test Do all quality control checks as directed and consult with a diabetes healthcare professional These recommendations apply to all blood glucose monitoring systems and are supported by the American Association of Diabetes Educators the American Diabetes Association the U S Food and Drug Administration and the Advanced Medical Technology Association Important Information D Severe dehydration resulting from excess
19. he C button and the next most recent test result will appear The meter will recall up to your last 150 test results in order from the most recent to the oldest When the memory is full the oldest result is dropped and the newest is added To move through the tests more quickly press and hold the C button ctl will appear with control solution tests STEP 3 Otra Exit the Memory Mode Press the M button to turn off the meter LIFESCAN r JEW A 33 34 Downloading Test Results to a Personal Computer Transferring test results with date and time from the meter memory to your personal computer requires OneTouch Diabetes Management Software with the accompanying LifeScan Interface Cable OneTouch Software is available separately STEP 1 Install OneTouch Software Follow the instructions provided in the OneTouch User Manual STEP 2 Connect the LifeScan Interface Cable Connect the LifeScan Interface Cable to a serial port on the back of your computer and with the meter turned off to the meter data port PE will appear on the meter display when the first command is received indicating that the meter is in the communication mode NOTE While in the communication mode you will be unable to perform a blood glucose test If the meter is in either memory or setting mode it will not respond to computer commands STEP 3 Transfer Data Follow the instructions in the OneTouch
20. ing control solution results If test results fall outside the range printed on the test strip vial repeat the test Out of range results may be caused by one or more of the following gt Error in performing the test Failure to shake the control solution vial well Expired or contaminated control solution The meter test strips or control solution are too warm or too cold Failure to discard the first drop of control solution and wipe the dispenser tip clean gt Improper meter coding Test strip deterioration gt Meter malfunction CAUTION If you continue to get control solution test results that fall outside of the range printed on the vial the system may not be working properly Do not use the meter Call LifeScan Customer Services at 1 800 227 8862 17 Testing Your Blood Read this section and the test strip package insert carefully before testing Make sure you have all items needed to test D Meter D Test Strips gt Sampler gt Optional UltraClear Cap D Sterile Lancet Preparing the OneTouch UltraSoft Sampler Depth Adjustment Knob Puncture Settings Ejection Cocking Control Release Button Lancet with UltraClear Cap I Protective Disk For Arm Sampling Protective Disk i Cap Depth Indicator CAUTION To reduce the chance of infection D Never share a lancet or the OneTouch UltraSoft Sampler with anyone D Always use a new ste
21. is message does not mean I l that the system detected ketones but zm that testing with a ketone test strip _ LI _ may be advisable Consult your mg dL healthcare professional about when I 3n 1j 54 and how to test for ketones 31 Using the Meter Memory Your OneTouch Ultra Meter stores the 150 most recent blood glucose and control solution test results with date and time in its memory It also provides you with 14 and 30 day averages of your blood glucose test results Review the test results in memory with these easy steps STEP 1 Enter the Memory Mode You may enter the memory mode either with the meter turned off or immediately after completing a test Press the M button mem and the 14 day average will appear with the mg dL number of blood glucose tests performed in Have odn this period After three seconds the 30 day average will appear If you are using the meter for the first time indicates there are no test results in memory LI These averages are calculated from the blood glucose results obtained during the last 14 and 30 calendar days AH result will be included I I in your averages as 600 mg dL and a LI result I U E as 20 mg dL Results marked as control solu _ xn tion tests will not be included in your averages mg dL JU ave 13Un 32 STEP 2 Recall Test Results The most recent test result with date and time will appear Press and release t
22. itional information in the OneTouch Ultra Test Strip package WARNING Keep the test strip vial away from children the cap is a choking hazard Also the cap may contain drying agents that are harmful if inhaled or swallowed and may cause skin or eye irritation 10 Before Testing Checking the Meter Display cada ci Ketenes mem Each time you turn on the OneTouch Ultra l1 TY r Meter either by inserting a test strip or axo axze pressing the M button all segments of the display will appear briefly This tells you that LILILI 2 mmol L mg dL the system is performing several self checks to n 0 88 RA OBB AM AVG confirm that the meter is working properly To check that all display segments are working hold the C button down Coding the Meter Code numbers are used to calibrate the OneTouch Ultra Meter with OneTouch Ultra Test Strips for accurate results You must code the meter before using it for the first time and then every time you change to another vial of test strips Each time you test check to be sure that the code number on the meter display matches the code number on the test strip vial CAUTION Failure to code the meter correctly will cause inaccurate test results STEP 1 Enter the Code Mode Insert a test strip to turn on the meter Push it all the way in until it will go no further Avoid bending the test strip The display check will appear Then the code number is displ
23. ive water loss may cause false low results If you believe you are suffering from severe dehydration consult a healthcare professional immediately D Test results below 70 mg dL mean low blood glucose hypoglycemia Test results greater than 240 mg dL mean high blood glucose hyperglycemia If you get results below 70 mg dL or above 240 mg dL and do not have symptoms first repeat the test If you have symptoms or continue to get results that fall below 70 mg dL or above 240 mg dL follow the treatment advice of your healthcare professional gt If you are experiencing symptoms that are not consistent with your blood glucose test results AND you have followed all instructions described in the OneTouch Ultra Owner s Booklet call your healthcare professional D A red blood cell count hematocrit that is either very high above 5596 or very low below 30 can cause false results The Complete OneTouch Ultra Blood Glucose Monitoring System BE CN ONE OUCH Liira ae wap OneTouch Ultra Meter OneTouch UltraSoft Sterile Lancets Owner s Booklet OneTouch Ultra Control Solution Quick Start Guide OneTouch Ultra Test Strips may be sold separately Quick Reference Guide Carrying Case OneTouch UltraSoft Adjustable Blood Sampler Warranty Registration Card Optional UltraClear Cap Logbook OneTouch Ultra Blood Glucose Meter DISPLAY TEST PORT Symbols simple Insert the OneTouch Ultra
24. ly a drop of blood to the narrow channel here in the top edge of the test strip CONFIRMATION WINDOW Check here to confirm if enough blood has been applied CONTACT BARS Insert this end of the test strip contact bars facing up into the meter Push it all the way in until it will go no further Important Test Strip Information gt Store test strip vials in a cool dry place below 86 F 30 C Keep away from direct sunlight and heat Do not refrigerate gt Store test strips in their original vial only To avoid damage or contamination do not transfer test strips to any other place Do not use test strips beyond the expiration date printed on the package since they may cause inaccurate results D After removing a test strip from the vial replace the vial cap immediately and close it tightly With clean dry hands you may touch the test strip anywhere on its surface D Use each test strip immediately after removing it from the vial Count three months from the date you first open a new vial of test strips and write this date on the vial label Throw test strips and vial away after this discard date Apply only OneTouch Ultra Control Solution or a blood sample to the test strip Do not bend cut or modify test strips in any way OneTouch Ultra Test Strips are for single use only Never reuse a test strip that has had either blood or control solution applied to it gt Refer to add
25. messages and test Test Strip here results appear here ONETOUCH Itra mem I TLI Li mg dL Ld J45 LIFESCAN M BUTTON C BUTTON Used to turn meter M C Used to on to enter change date time and gt setting mode code number gt memory mode indicate control solution tests review test results in memory DATA PORT Used to download your test results to a computer OneTouch Ultra Meter Display CTL Indicates a control solution test result CODE Appears with the code number of the test strips BLOOD DROP SYMBOL Tells you when to apply the DECIMAL POINT le SESS Appears in test results only when unit of measure is set to mmol L BATTERY SYMBOL Warns when the battery is low or MMOL L must be replaced Unit of measure used in other parts of the world test result is above 240 mg dL to sug gest ketone testing HOUR MINUTES MEM Indicates a test result stored in memory TEST RESULT AREA Test results are displayed here MG DL Unit of measure Milligrams per deciliter mg dL is the standard in your region OneTouch Ultra Test Strips The OneTouch Ultra System measures the amount of glucose in whole blood Blood is applied to the TOP EDGE of the OneTouch Ultra Test Strip With the FastDraw design of the OneTouch Ultra Test Strip the blood is automatically drawn into the reaction cell where the reaction takes place TOP EDGE App
26. n the Sampler Press and hold the sam pler against the arm for a few seconds Press the release button STEP 5 Allow Blood Drop to Form Continue holding the sampler against the skin for a few seconds until the blood drop forms Allow enough blood to form under the cap until you have a blood sample that is sufficient to fill the confirmation window of the test strip If you must massage the area to obtain more blood do not squeeze the site excessively If bruising occurs you may choose to lance a fingertip instead If you are having difficulty obtaining blood from the arm call LifeScan Customer Services at 1 800 227 8862 for assistance Important information about arm testing Under certain conditions blood glucose test results obtained using samples taken from your arm may differ significantly from fingertip samples P The conditions in which these differences are more likely to occur are when your blood glucose is changing rapidly such as following a meal an insulin dose or associated with physical exercise When blood glucose is changing rapidly fingertip samples show these changes more quickly than arm samples When your blood glucose is falling testing with a fingertip sample may identify a hypoglycemic low blood sugar level sooner than a test with an arm sample P Use arm samples only for testing prior to or more than two hours after meals insulin dose or physical exercise D Testing performed wi
27. omer Services at 1 800 227 8862 Repeat the test with a new test strip Apply blood or control solution sample only after the amp symbol appears on the dis play Refer to pages 27 28 for information on sample application 51 MESSAGE WHAT IT MEANS Error message that indicates one of the following condi tions may be present 1 You may have high glu cose and have tested in an environment near the low end of the system s oper ating temperature range 43 111 F 6 440 There may be a problem with the test strip For example it may have been damaged or moved during testing ACTION 1 If you tested in a cool environment repeat the test in a warmer environ ment with a new test strip If the error mes sage appears again contact LifeScan Customer Services at 1 800 227 8862 2 If you were testing in a normal or warm environ ment repeat the test with a new test strip See pages 8 9 for test strip information If the error message appears again contact LifeScan Customer Services at 1 800 227 8862 MESSAGE WHAT IT MEANS ACTION 3 The sample was 3 If you applied the blood improperly applied incorrectly review pages 27 28 on blood application and repeat the test with a new test strip If the error mes sage appears again contact LifeScan Customer Services at 1 800 227 8862 Error message that indicates Repeat the test with a that the meter has detected a new test strip Refer
28. on and wipe the sampler thoroughly Soak only the cap or caps for at least 30 minutes in the disinfectant solution Do not soak the sampler in liquid Rinse the sampler and cap with water and dry thoroughly Battery Your OneTouch Ultra Meter comes with a pre installed 3 0 V 42032 or equivalent lithium battery The battery will provide you with enough power to perform about 1 000 tests When replacing the battery use only a 3 0 V 2032 or equivalent lithium battery The meter will alert you when the power is getting low by displaying two different messages The symbol appears on the display with the unit of measure when the meter is turned on and all other display mes sages are functional From the time the em symbol first appears there is enough power left for about 50 tests The cx mg dL test results will be accurate but it is time to change the battery 43 When the symbol appears on the display by itself it means that the battery will not provide enough power for a test You must change the battery To replace the battery make sure that the meter is turned off Turn the meter over and locate the battery compartment STEP 1 B Open the battery compartment Push up on the tab and pull the battery compartment cover toward you 44 Pu 2 Remove the old battery Pull upward on the ribbon Insert one 3 0 V 2032 or equivalent lithium battery nw sure the positive side o
29. p in a sealed container Used Lancet Disposal LU TL I Ji 0 30 ims Plasma Calibrated Result It is important to discard the used lancet carefully STEP 1 Remove the Sampler Cap Twist the cap counterclockwise Optional Replace the protective disk on the used lancet by placing it on a hard surface and pushing the lancet tip into the disk 29 STEP 2 Eject the Lancet Point the sampler down and away Push forward on the ejection cocking control and eject the lancet directly into a container for sharp objects Return the ejection cocking control to the middle position Replace the cap Special Messages The OneTouch Ultra Meter displays results between 20 and 600 mg dL If your blood glucose test result is lower than 20 mg dL 1 0 will appear on the meter display This indicates severe hypoglycemia low blood glucose You should treat this condition immediately according to the recommendations of your healthcare professional i your blood glucose test result is above 600 mg dL H will appear on the meter display This indi cates severe hyperglycemia high blood glucose You should recheck your blood glu cose level If Hi again appears on the display call your health care professional immediately Es ketones When your blood glucose test result is above 240 mg dL or reads H ketones will appear on the meter _ Dn display Th
30. rile lancet Lancets are for single use only P Keep the OneTouch UltraSoft Sampler clean 19 STEP 1 Insert a Lancet Turn the cap counterclockwise to remove it Insert the lancet into the lancet holder and push down firmly until it is fully seated Do not twist the lancet Twist the protective disk until it separates from the lancet Replace the OneTouch UltraSoft Cap Turn it clockwise until it is snug Adjust the puncture depth setting if necessary Twist the depth adjustment knob toward the smaller bumps for a shallower puncture or toward the larger bumps for a deeper puncture 20 STEP 2 Cock the Sampler Slide the ejection cocking control back until it clicks If it does not click the sampler may have been cocked when the lancet was inserted The sampler is now ready for use STEP 3 Wash Your Hands and the Puncture Site Use warm soapy water Rinse and dry thoroughly 21 22 Fingertip Blood Sampling The OneTouch Ultra System requires a very small blood drop to per form a test You may obtain it from a fingertip or arm See page 23 for information on obtaining a blood sample from the arm Choose a dif ferent puncture site each time you test Repeated punctures in the same spot may cause soreness and calluses STEP 1 Position the Sampler Hold the OneTouch UltraSoft Sampler firmly against the side of your finger Press the release button STEP
31. s at 1 800 227 8862 or visit our Web site at www LifeScan com Table of Gontents CER EE d About Your New System iv The Complete OneTouch Ultra Blood Glucose Monitoring System 4 OneTouch Ultra Blood Glucose Meter 5 OneTouch Ultra Meter Display 6 OneTouch Ultra Test Strips 8 Before Testing 10 Checking the Meter Display 10 Coding the Meter 10 Checking the System 13 Gm Testing Your Blood 18 Preparing the OneTouch UltraSoft Adjustable Blood Sampler 19 Fingertip Blood Sampling 22 Arm Blood Sampling 23 Step by Step Test Procedure 26 Used Lancet Disposal 29 Special Messages 30 GIOCA GER I pe er Using the Meter Memory 32 Downloading Test Results to a Personal Computer Comparing Meter and Laboratory Results 36 Gru M M J Setting the Meter 38 Caring for Your ONETouc Ultra System 42 Meter 42 OneTouch UltraSoft Sampler 42 Battery 45 el Display Messages and S 23 Problem Solving Guide wn an Specifications Guarantee wn Index wn o About Your New System The OneTouch Ultra System uses the latest blood glucose monitoring technology It measures the glucose content of a blood sample by means of an electrical current produced in the test strip and sent to the meter for measurement Test results are plasma calibrated This makes it easier for you and your diabetes care team to compare your meter results wit
32. st eight hours before doing comparison tests gt Take your meter with you to the lab While at the lab D Make sure that the meter test and the lab test are performed within 15 minutes of each other D Wash your hands before obtaining a blood sample gt Use only fresh capillary blood obtained from the fingertip You may still have a variation from the result because blood glucose levels can change significantly over short periods especially if you have recently eaten exercised taken medication or experienced stress In addition if you have eaten recently the blood glucose level from a fingerstick can be up to 70 mg dL higher than blood drawn from a vein venous sample used for a lab test Therefore it is best to fast for eight hours before doing comparison tests Factors such as the amount of red blood cells in the blood a high or low hematocrit or the loss of body fluid severe dehydration may also cause a meter result to be different from a laboratory result References 1 Surwit R S and Feinglos M N Diabetes Forecast 1988 April 49 51 2 Sacks D B Carbohydrates Burtis C A and Ashwood E R ed Tietz Textbook of Clinical Chemistry Philadelphia W B Saunders Company 1994 959 37 38 Setting the Meter Time and Date The OneTouch Ultra Meter comes with the time date and unit of measure preset However if you need to change the time or if you remove the battery you may nee
33. thin two hours after meals insulin doses or physical exer cise or whenever you feel that your glucose levels may be changing rapidly should be done with a fingertip sample You should also use fingertip testing whenever you have a concern about hypo glycemia insulin reactions such as when driving a car particularly if you suffer from hypoglycemic unawareness lack of symptoms to indicate an insulin reac tion as arm testing may fail to detect hypoglycemia What you should do D Use arm or fingertip samples for testing prior to or more than two hours after meals insulin dose or physical exercise D Routine testing before meals can be done either at the fingertip or the arm P Consult your healthcare professional before you begin using the arm for testing 25 26 Step by Step Test Procedure STEP 1 Insert Test Strip Insert a test strip contact bars end first and facing up into the test port Push it in until it will go no further The meter will turn on and the display check will appear briefly Then the code number will appear followed by the symbol with the unit of measure Check that the unit of measure is set correctly Be sure the meter and test strip codes match If they do not code the meter correctly See pages 10 12 Insert This End STEP 2 Apply Sample Obtain a round drop of blood using the OneTouch UltraSoft Adjustable Blood Sampler The blood sample must be at least 1
34. ttery Operating Ranges Temperature 43 111 F 6 44 C Relative Humidity 10 90 Hematocrit 30 55 Guarantee The makers guarantee that the OneTouch Ultra Meter shall be free of defects in material and workmanship for a period of three years This guarantee is valid from the date of purchase The guarantee extends only to the original purchaser and is not transferable 57 58 Arm Blood Sampling i i lt Qane l eee Re ao ep ERE pac 23 Averages 14 and 30 Day ss isses 32 hoc arotar mcn 43 Blood Sampling ArM e oe eH reb OD es 23 Blood Sampling Fingertip sese 22 C BUllOfh gt eb oett oor eom p ettet p UON HE d eae 5 Checking the Meter Display LL a KK KK KK KK KK k 10 Checking the Syste ree pore ka kilk Wen bel a IO e kerka 13 Coding the Meter ia ca ayna Wale rep Wa an El ore ten se d k 10 Control Solution Checking with 13 Control Solution OneTouch Ultra 2 0 2 0 cece cece eee 15 Control Solution Results Comparing 0 0 kak eee 17 Control Solution Test Information Important sese 14 Data Downloading d oe rte klanan icons ee bL Sah e K eed 34 Data LR mt e ggmo Yaaa 34 Display Messages Problem Solving Guide L LR eee eee 46 Fingertip Blood Sampling ss lt alk qame n salla I 22 reni EE 57 OneTouch Software c A kces cC B b n een 35 Laboratory Results Comparing Meter Results with
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