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Blood Glucose Monitoring System

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DCO_06158108A_OUS_OBC_GB  5/6/03  1:13 PM  Page i

Summary of Contents for ONETOUCH ULTRASMART

Page 1: ...Blood Glucose Monitoring System M e t e r a n d E l e c t r o n i c L o g b o o k I n O n e O w n e r s B o o k l e t DCO_06158108A_OUS_OBC_GB 5 6 03 1 13 PM Page i...

Page 2: ...Owner s Booklet UltraSmart Blood Glucose Monitoring System DCO_06158108A_OUS_OB_GB 5 6 03 1 24 PM Page i...

Page 3: ...ii Serial Number Lot Number In Vitro Diagnostic Medical Device Expiration Date Symbol Sterilized by irradiation Symbol SN LOT IVD Symbols DCO_06158108A_OUS_OB_GB 5 6 03 1 24 PM Page ii...

Page 4: ...microlitre and five seconds to provide you with an accurate plasma calibrated test result The OneTouch UltraSmart Meter also has a memory that allows it to function as an electronic logbook Now you ca...

Page 5: ...rovides the user with electronic logbook functions which serve to store such data as insulin and oral medication doses food intake amount of exercise health information such as illnesses and other per...

Page 6: ...3 mmol L and do not have symptoms first repeat the test If you have symptoms or continue to get results that fall below 3 9 mmol L or above 13 3 mmol L follow the treatment advice of your healthcare p...

Page 7: ...Meter 10 Checking the System 12 TESTING YOUR BLOOD 19 Preparing the OneTouch UltraSoft Sampler 20 Fingertip Blood Sampling 23 Arm Blood Sampling Alternate Site 24 Step by Step Test Procedure 28 Used...

Page 8: ...s 62 YOUR METER LOGBOOK 73 Comments 73 Rules for Adding Comments 74 How to Add a Comment 74 Logbook Entries 78 Using the SmartButtons 78 Rules for Logbook Entries 80 Entering the Date and Time 81 Addi...

Page 9: ...viii DCO_06158108A_OUS_OB_GB 5 6 03 1 24 PM Page viii...

Page 10: ...are about 12 higher The OneTouch UltraSmart Blood Glucose Monitoring System consists of three main products the OneTouch UltraSmart Meter OneTouch Ultra Test Strips and OneTouch Ultra Control Solution...

Page 11: ...est strip here DATA PORT Used to download logbook memory to a computer DISPLAY WITH BACKLIGHT Test results messages symbols and other data appear here SmartButtons See pages 4 5 for description and us...

Page 12: ...urn off the meter ARROW BUTTON Scroll through menus code numbers and logbook OK BUTTON BACKLIGHT BUTTON Accept entries and move to next display Press and hold for two seconds to turn on backlight Note...

Page 13: ...iabetes management plan into the large logbook memory There are SmartButtons for exercise health medication and food The FastFacts SmartButtons is used to view the records in the logbook memory You ma...

Page 14: ...FOOD SmartButton Enter meal and snack information FastFacts SmartButton Review test results and logbook memory Note For complete information on using the Exercise Health Medication and Food SmartButt...

Page 15: ...lighter press and hold the Back button and down Arrow button Scroll move up only Scroll down only Scroll up or down Scroll up or down No entry Shows where you are on the display Press OK to accept hi...

Page 16: ...eaction takes place See pages 19 35 Testing Your Blood for complete instructions Contact Bars Insert this end of the test strip contact bars facing up into the meter Push it all the way in until it wi...

Page 17: ...clean dry hands you may touch the test strip anywhere on its surface 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...

Page 18: ...is set at the factory to display results in the English language using millimole per litre mmol L as the unit of measure The time and date are also factory set If you are using the meter for the firs...

Page 19: ...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 Insert a OneTouch Ultra Test Strip to turn on the meter Push it...

Page 20: ...he Code Numbers STEP 3 See the Code Number STEP 2 11 Note The code number appears on the display briefly If you were unable to change the code in time or entered a code number in error press the Back...

Page 21: ...eTouch 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 contai...

Page 22: ...t strips should be at room temperature between 20 and 25 C before testing Shake the bottle discard the first drop of control solution and wipe off the dispenser tip to ensure a good sample and an accu...

Page 23: ...e not consistent with how you feel After dropping the meter Before you use the OneTouch UltraSmart Meter to test your blood for the first time practice the procedure using control solution When you ca...

Page 24: ...t will go no further OneTouch UltraSmart will appear briefly on the display Then Code 9 example Check Code is displayed Be sure the meter and test strip codes match If they do not code the meter corre...

Page 25: ...ay first Use the Arrow button to select Control Solution The meter will automatically identify the test as a control solution test in the logbook There are three choices in test mode Use the Arrow but...

Page 26: ...turn itself off Remove the test strip and insert it back into the test port to restart the test procedure To ensure an accurate result Shake the bottle well Discard the first drop Wipe the dispenser...

Page 27: ...red or contaminated control solution Meter test strips or control solution that are too warm or too cold Failure to discard the first drop of control solution and wipe the dispenser tip clean Improper...

Page 28: ...or arm sampling OneTouch UltraSoft Sterile Lancet 19 CAUTION It is important to learn the correct blood application technique see page 30 If you do not apply blood to the test strip correctly you may...

Page 29: ...Protective Disk Lancet Point Lancet with Protective Disk Depth Indicator Puncture Settings CAUTION To reduce the chance of infection Never share a lancet or the OneTouch UltraSoft Sampler with anyone...

Page 30: ...ncet 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 punct...

Page 31: ...s not click the sampler may have been cocked when the lancet was inserted The sampler is now ready for use Use warm soapy water Rinse and dry thoroughly Cock the Sampler STEP 2 Wash Your Hands and the...

Page 32: ...pler STEP 1 Hold the OneTouch UltraSoft Sampler firmly against the side of your finger Press the release button Fingertip Blood Sampling The OneTouch UltraSmart System requires a very small blood drop...

Page 33: ...e 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 rapi...

Page 34: ...you should do Use arm or fingertip samples for testing prior to or more than two hours after meals insulin doses or physical exercise Routine testing before meals can be done either at the fingertip o...

Page 35: ...usly or applying heat briefly may be helpful Select a soft fleshy area on your arm that is away from bone and free of visible veins and hair Wash and dry the area Choose the Puncture Site STEP 2 Posit...

Page 36: ...te excessively Allow Blood Drop to Form STEP 5 If bruising occurs you may choose to lance a fingertip instead If you are having difficulty obtaining blood from the arm call your local LifeScan Custome...

Page 37: ...r The meter will turn on automatically OneTouch UltraSmart will appear briefly on the display Then the code number will appear Be sure the meter and test strip codes match If they do not code the mete...

Page 38: ...display first If you are testing with a fingertip blood sample proceed to Step 3 If you are testing with a blood sample from the arm use the Arrow button to scroll to Alternate Site Before you test wi...

Page 39: ...ual size to fill the confirmation window Apply Sample STEP 3 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 te...

Page 40: ...ation If the confirmation window is not full you may get an error message or an inaccurate test result Good Sample Sample Too Small Note If you do not apply a blood sample within three minutes the met...

Page 41: ...st you can compare the result with your last test and your average for this time of day by pressing the Arrow button Yourresult 5 8 Previous BefBrkft 6 3 13Sep02 21 55 Avg 14days 5 3 Note If Comment P...

Page 42: ...p Used Lancet Disposal CAUTION It is important to discard the used lancet carefully to avoid injury or illness Follow proper precautions in accordance with local regulations when disposing of all mate...

Page 43: ...mmediately WARNING Below 1 1 mmol L LOW GLUCOSE WARNING Above 33 3 mmol L HIGH GLUCOSE Special Messages The OneTouch UltraSmart Meter displays results between 1 1 mmol L and 33 3 mmol L If your test r...

Page 44: ...set in custom meter set up the meter will prompt you to add a comment When your blood glucose test result is in the range of 13 3 mmol L to 33 3 mmol L Check Ketones will appear on the meter display...

Page 45: ...nder normal conditions A result within that range is considered accurate when testing with the OneTouch UltraSmart Meter However results can differ by more than 20 in some situations See the OneTouch...

Page 46: ...level from a fingerstick can be up to 3 9 mmol L higher than blood drawn from a vein venous sample used for a lab test 2 Therefore it is best to fast for eight hours before doing comparison tests Fac...

Page 47: ...pe down the outside of the meter Your OneTouch UltraSmart Meter is a precision instrument Please handle it with care OneTouch UltraSoft Sampler Clean the sampler and caps with soap and water as needed...

Page 48: ...depending on backlight use When replacing the batteries use only two AAA alkaline batteries The meter will alert you when the power is getting low by displaying two different messages WARNING Low Batt...

Page 49: ...urn the meter over and locate the battery compartment 2 Remove the old batteries Insert two AAA alkaline batteries Plus and minus signs will guide you in placing the batteries 3 Place the battery comp...

Page 50: ...However the date and time settings may need to be updated The first time you turn on the meter after replacing the batteries the meter will go into the Set up mode At this time you may update the date...

Page 51: ...ned on It indicates that the system has performed several self checks to confirm that the meter is working properly ACTION If at any time during the life of the meter these graphics appear to be diffe...

Page 52: ...sing ACTION See Coding the Meter pages 10 12 Make sure that this code number matches the code number on the vial of the test strips you are using Check to be sure the code number on the display matche...

Page 53: ...accept a blood sample from the arm The system is ready to accept a control solution sample ACTION You may now apply the fingertip blood sample You may now apply the arm blood sample You may now apply...

Page 54: ...test result A blood glucose test result in mmol L A test result outside of your target range with a message prompting you to add a comment ACTION None required None required If you wish to add a comm...

Page 55: ...sult is between 1 1 mmol L and 3 9 mmol L Do you need a snack will appear on the display with the test result reminding you that a meal or snack may be necessary ACTION Follow the instructions of your...

Page 56: ...vice office See back cover for contact information 47 MESSAGE WHAT IT MEANS You may have a very low blood glucose level lower than 1 1 mmol L You may have a very high blood glucose level exceeding 33...

Page 57: ...within the operating range To reset the meter you must turn the meter off and enter set up mode see pages 54 57 Reset the language time and date You must also reset the meter code to match the code o...

Page 58: ...ip information If the error message persists contact your local LifeScan Customer Service office See back cover for contact information Repeat the test with a new test strip Apply the blood or control...

Page 59: ...the test in a warmer environment with a new test strip If you were testing in a normal or warm environment repeat the test with a new test strip See pages 7 8 for test strip information If you applied...

Page 60: ...from the time this symbol first appears The power of the batteries is too low to run a test ACTION Repeat the test with a new test strip Refer to pages 30 31 for information on sample application Tes...

Page 61: ...lace the batteries Check that the batteries are correctly installed Insert the test strip correctly with the contact bars end first and facing up Push it in until it will go no further Call your local...

Page 62: ...strip Defective meter WHAT TO DO Repeat the test with a new test strip and a larger sample Repeat the test with a new test strip Repeat the test with a new test strip apply sample only after Apply Blo...

Page 63: ...averages meal schedule target glucose range and hypoglycaemia level Entering Basic Set up Mode To enter Set up mode press and hold down the Back button and the OK button at the same time for three sec...

Page 64: ...gu s Dutch Nederlands To use English press OK OK Selecting Display Language The meter is set at the factory to use English You may choose one of six other languages in Set up mode This message will ap...

Page 65: ...l display the factory set time and date If the date and or time are incorrect follow these steps in Set up mode See page 54 Entering Basic Set up Mode Use the Arrow button to scroll to the correct min...

Page 66: ...ct No use Arrow button and press OK the meter will turn off and continue to use the factory settings OK OK Do you want to customize your meter now Yes No Do you want to customize your meter now Yes No...

Page 67: ...our target glucose range your usual meal times and much more information Set up Menu After completing Basic Set up choose Yes to customize your meter 58 Note If you are starting the custom set up sequ...

Page 68: ...ar on the display with a list of options Settings will be highlighted You should have your OneTouch UltraSmart Owner s Booklet available to refer to while customizing the meter DCO_06158108A_OUS_OB_GB...

Page 69: ...Insulin Pump FACTORY 24 hour DD MM YY Monday mmol L ON Pill A Pill B InsulinA InsulinB OFF CUSTOM AM PM MM DD YY Monday mg dL OFF Pill A to E or Customize with OneTouch Software Rapid Regular Lente N...

Page 70: ...eatures Averages Schedule Glucose Range Before Meal After Meal Hypo Level FACTORY 14 days Pre set see pages 70 71 5 0 7 2 mmol L 3 9 mmol L CUSTOM 7 30 60 90 days Personal Personal Personal Personal D...

Page 71: ...OK to save your settings before turning off the meter or allowing it to turn off automatically You may set your meter to use a 12 hour am pm time format or a 24 hour military time format 24 00 Use the...

Page 72: ...in the test procedure To keep the beeps highlight ON and press OK For silent meter operation highlight OFF and press OK OK OK For record keeping purposes you may begin your week on Sunday or Monday U...

Page 73: ...appear on your pill entry display 64 Using the Arrow button scroll to Diabetes Pill Set up and press OK OK Enter the number of pill types you are taking not the number of tablets you take each time S...

Page 74: ...Software Using the Arrow button scroll down to your choice and press OK Pill 2 will be highlighted automatically To enter a second type of diabetes pill choose Pill B E to describe the second pill and...

Page 75: ...h Software If you do not customize your insulin names the factory settings of Insulin A and Insulin B will appear on your medication entry display 66 Scroll to the number of insulin types you use and...

Page 76: ...s OK on your selection Repeat these steps until all of your insulin types have been selected OK To save your insulin choices use the Arrow button to scroll to Save and press OK OK Rapid Regular Lente...

Page 77: ...uch UltraSmart Meter allows you to store current information about your pump The factory setting will be set as if you do not use a pump Select Yes to use this feature and press OK You can then use th...

Page 78: ...nt to include in your test display average and press OK You can still look at averages for all five time periods by reviewing your meter logbook OK 69 Select Advanced Features as follows Select Advanc...

Page 79: ...OK OK 70 Next the meter will prompt you to select time periods for your usual meal schedule When you set this feature all of your test results will be tagged with the mealtime To view a pre set meal...

Page 80: ...correct and that your medication set up and mealtimes are set according to your personal daily schedule Otherwise some FastFacts information will not be correct You have the option to modify the meal...

Page 81: ...care professional and wish to enter it use the Arrow button to scroll to your target numbers and press OK OK The factory set hypoglycaemia level is 3 9 mmol L If your healthcare professional has advis...

Page 82: ...d DEFINITION COMMENTS ON GLUCOSE RESULTS Comments Information that you store in your meter logbook along with a test result is called a comment Following is a list of comments that you may store Exerc...

Page 83: ...you have stored To remove an entry select from the menu Press and hold the Back button to turn off the meter After one minute of no activity the meter will turn off automatically To go back into the l...

Page 84: ...side of your glucose target range You can however add a comment to a test result whether or not Comment Press OK appears In this example we will comment on a test result with food exercise and health...

Page 85: ...Health Once you select your mealtime Health is automatically highlighted If you are through commenting scroll to Save and press OK If you do not press OK your entries will not be saved OK OK You can...

Page 86: ...ep 02 10 30 Exer Save Health 1 Health 2 Food Stress Bef Lunch Gluc 7 5 Comment 8 Sep 02 10 30 Exer Health 1 Health 2 Food Stress After Save When you have completed making comments scroll to Save and p...

Page 87: ...SmartButtons The SmartButtons allow you to enter information about your diabetes management plan There are SmartButtons for exercise health medication and food To make a logbook entry press the approp...

Page 88: ...1 3 and units Insulin Pump Health Notes Health Checks Mild Moderate Hard Duration enter length of time Stress Feel Hypo Illness Menses Vacation Other Carbs Calories Fats Proteins Ketones HbA1c Microal...

Page 89: ...selected Use the Arrow button to choose either the date and time displayed or Other Time Use the OK button to confirm your choices and the logbook display will appear If no logbook display appears you...

Page 90: ...5 5 12 19 26 6 13 20 27 7 14 21 28 1 8 15 22 29 2 16 23 30 3 10 17 24 Select Entry Date Sep 02 9 What time 22 30 8 Sep 02 Entering the Date and Time If the logbook entry is for the current date and ti...

Page 91: ...e to add an exercise logbook entry at this time Select Other Time if the logbook entry is for some time in the past and press OK OK Note that the date and time is correct for your entry You may rate t...

Page 92: ...5 Sep 02 15 30 Health Notes The exercise logbook entry you recorded will be saved this way in your meter logbook You may also scroll through the logbook to view previous entries Press OK while you are...

Page 93: ...Weight Height Cholesterol Dr Visit Blood Pressure Health Checks are another type of health logbook entry that you can record Health Checks include home and laboratory tests as well as doctors examina...

Page 94: ...are sample entries under Health Checks When you have completed your Health Check entries scroll to Exit Health Checks and press OK Your Health Check entry will be saved in the meter logbook Ketones OK...

Page 95: ...inished with your entries press OK with Exit Health Checks highlighted If you wish to enter other Health Checks use the Arrow button to scroll to the additional menu choice and press OK OK OK 86 Your...

Page 96: ...value will start at the value you last saved Scroll to your selection and press OK OK Tests for haemoglobin A1c also known as HbA1c or A1c can be recorded from 4 to 15 in 1 steps When entering data th...

Page 97: ...h Checks LDL Cholesterol 4 8 Total HDL Trig Note When entering data the value will start at the value you last saved You may enter cholesterol test results in 1 mg dL 0 1 mmol L steps for Total up to...

Page 98: ...To record a foot examination select Enter Foot Exam and press OK OK Foot Exam To record an eye examination select Enter Eye Exam and press OK OK Eye Exam DCO_06158108A_OUS_OB_GB 5 6 03 1 25 PM Page 8...

Page 99: ...o the doctor select Enter Dr Visit Enter your weight in 0 5 kg steps and your height in 0 5 cm steps When entering data the value will start at the value you last saved Weight Height Doctor Visit DCO_...

Page 100: ...A Press the Medication SmartButton to access the menu You may track your diabetes pills insulin types and dosages and insulin pump information Select the current date and time or Other Time See page...

Page 101: ...ry Pump Bolus Pump Daily Total InsulinB Diabetes Pills To enter your diabetes pills select the pill you have taken and press OK OK Enter the number of pills you have taken in 0 5 or one half pill step...

Page 102: ...dosage by highlighting an insulin type and press OK OK Then record the units of insulin The meter was set at the factory to record units in 0 1 increments When entering data the value will start at t...

Page 103: ...lus 8 Sep 02 21 20 Meds Entry 0 1 8 Sep 02 21 20 Meds Entry InsulinA InsulinB Pill B Pump Daily Total Pump Bolus Pill A Insulin Pump You can enter insulin pump information as bolus entries or as a dai...

Page 104: ...s InsulinA InsulinB Pill B Pump Daily Total Pill A 8 Sep 02 21 20 Meds Entry InsulinA InsulinB Exit Meds Entry Pump Daily Total Pill B PillA If you have completed your medication logbook entry select...

Page 105: ...sulinB Pump Bolus InsulinA Use the Arrow button to scroll to the number of units you have taken over the past 24 hours and press OK When entering data the value will start at the value you last saved...

Page 106: ...her Time FOOD LOGBOOK ENTRIES Food and blood glucose levels are closely linked Logbook entries allow you to keep track of important nutritional information for each meal or snack by type of nutrient P...

Page 107: ...s whichever you prefer Calories may be entered in 5 unit steps in the range of 0 to 2550 Use the Arrow button to change the units for each item If you do not wish to enter units for an item select and...

Page 108: ...ook from the FastFacts menu and press OK The most recent entry in your logbook will appear on the display Step 3 Use the Arrow button to scroll through your logbook entries OK Note the location of the...

Page 109: ...have completed editing the comments scroll to Save and press OK OK OK 100 Bef Lunch Gluc 6 9 Comment 8 Sep 02 10 30 Food Exer Health Save To change the mealtime scroll to Food and press OK OK Scroll t...

Page 110: ...way in your meter logbook EDITING OR DELETING LOGBOOK ENTRY Example All logbook entries are edited or deleted in the same way Use the Arrow button to highlight the logbook entry you wish to change and...

Page 111: ...roteins 45 15 Make sure the icon date and time and description are correct If you make an error press the Back button to return to the menu Press OK on the selected mealtime If you wish to change the...

Page 112: ...rom the logbook The edited entry will appear this way in your meter logbook To delete an entry highlight the entry and press OK OK Use the Arrow button to select Delete and press OK OK DCO_06158108A_O...

Page 113: ...oice Enter FastFacts by pressing the FastFacts SmartButton This will put you in the meter memory The FastFacts feature allows you to view charts and graphs of your test results and other logbook infor...

Page 114: ...Exercise Glucose averages before during and after exercise Glucose Range Info Percent of glucose test results within above and below target range before and after meals for the last 7 14 30 60 and 90...

Page 115: ...rds Comments are attached to a test result logbook entries are not GLUCOSE BY MEALS To review test results before and after meals select Glucose by Meals Highlight the desired mealtime and press OK A...

Page 116: ...ith the most recent test result flashing A bold bar above the dates indicates a weekend The two dotted lines indicate the lowest and highest values of your before and after meal glucose ranges see Adv...

Page 117: ...nd will not be able to use the Back button to return to the graph OK OK You may scroll backward or forward in time using the Arrow button to move from one point to another Individual test results will...

Page 118: ...raph it will move by one day Weekends are noted by a bold bar above the dates Average of All Results Test result averages are available for the last 7 14 30 60 and 90 days with the number of tests com...

Page 119: ...ys Before exercise During exercise After exercise 14 3 14 6 9 5 7 6 1 Avg by time of Day 14 Days 5 3 7 5 4 4 7 1 6 9 8 6 14 Bef Brkft 14 14 14 Aft Brkft Bef Lunch Bef Dinner Aft Dinner 7 Night 2 Avera...

Page 120: ...et up mode you may review the percentage of your test results that are above below and within your target ranges Otherwise before meal ranges are factory set at 5 0 7 2 mmol L After meal target ranges...

Page 121: ...e pages 70 71 to change your schedule INSULIN INTAKE Choose insulin intake from the FastFacts Menu The individual insulins in this example Regular and NPH are based on insulins selected in the Set up...

Page 122: ...ber means there has been at least one day in the time period without an entry 6 Syringe Totals To view the total of all individual insulins taken by syringe or insulin pen that you have previously sto...

Page 123: ...the last 7 14 30 60 or 90 days To view your total syringe insulin intake for each day scroll to Daily Totals and press OK OK If you did not record a syringe insulin intake for a particular day will a...

Page 124: ...Day Avg 6 0 8 0 14 Breakfast 6 00 11 00 14 Lunch 11 00 17 00 14 Day Avg Total Daily Pump Insulin 52 3 12 Insulin Intake Pump Bolus will display your average bolus intake for each mealtime Breakfast Lu...

Page 125: ...the last 7 14 30 60 and 90 days is displayed Use the Arrow button to view the other time periods 116 Insulin Intake Pump Daily Totals Pump Daily Totals gives the pump totals you have entered for each...

Page 126: ...will appear on the display OK B P Weight Height Chol Ketones Dr Visit 120 80 68 0 170 0 5 2 4 8 done 3 Sep 02 3 Sep 02 3 Sep 02 3 Sep 02 3 Sep 02 3 Sep 02 Health 3 Sep 02 HbA1c trace FOOD AVERAGES Se...

Page 127: ...loading Transferring test results to your personal computer for home viewing requires OneTouch Diabetes Management Software from LifeScan and a LifeScan Interface Cable OneTouch Software which include...

Page 128: ...d indicating that the meter is in the communication mode You are now ready to transfer all test results with date and time stored in the meter memory to your computer Install OneTouch Software on your...

Page 129: ...cover for contact information 120 Follow the instructions in the OneTouch Diabetes Management Software User s Manual to initiate the data transfer command If the command is not received within one mi...

Page 130: ...out six months at three tests per day one test using backlight Glucose Units mmol L Memory Over 3 000 records Automatic Shutoff Three minutes after inserting a test strip if sample has not been applie...

Page 131: ...336 Blood Glucose Meter Test Strips and Control Solution 0120 Lancets Blood Sampler IVDD 98 79 EC MDD 93 42 EC Authorised Representative LifeScan Regulatory Affairs Europe Division of Ortho Clinical D...

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Page 134: ...ibuted by LifeScan UK A Division of Ortho Clinical Diagnostics Enterprise House Station Road Loudwater High Wycombe Buckinghamshire HP10 9UF United Kingdom LifeScan Inc 2003 Milpitas CA 95035 Rev 04 2...

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