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Blood

Glucose

Monitoring

System

Owner's Booklet

Eas

Easy to Handle, 

y to Handle, Eas

Easy to Read

y to Read

Simple Blood Application

Simple Blood Application

Confirm

Confirms 

s Enough 

Enough Blood I

Blood Is Applied

s Applied

DCO_05074503A_OT_SS_OB_US  6/19/03  11:59 AM  Page C

Summary of Contents for ONETOUCH SURESTEP (WITH DATA PORT)

Page 1: ...s Booklet Eas Easy to Handle y to Handle Eas Easy to Read y to Read Simple Blood Application Simple Blood Application Confirm Confirms s Enough Enough Blood I Blood Is Applied s Applied DCO_05074503A...

Page 2: ...DCO_05074503A_OT_SS_OB_US 6 19 03 11 59 AM Page D...

Page 3: ...ded for use outside the body in vitro diagnostic use It should be used only for testing purposes and only with fresh whole blood samples It should not be used for the diagnosis of diabetes DCO_0507450...

Page 4: ...PORTANT If you have followed the tips to ensure accuracy and your blood glucose results are still out of range call your Healthcare Professional The OneTouch SureStep System kit contains many small pa...

Page 5: ...p Test Strips 8 Optional Color Chart 9 Display Symbols 10 Coding 13 Coding the Meter 13 Checking 15 Checking the System 15 Understanding Control Solution Results 20 Testing 22 Testing Your Blood 22 Te...

Page 6: ...ge Results 40 Maintenance 41 Caring for Your Meter 41 General Care 41 Cleaning the Meter 41 Changing the Batteries 44 Storage Instructions 47 Troubleshooting 48 Error Messages 48 Symbols 56 Symbols 56...

Page 7: ...Format 64 Date Format 64 Exiting the Set Up Mode 64 Memory 65 Background Information on Meter Memory 65 Getting All Results from Meter Memory 65 First Time Turning on Meter 67 Uploading Memory Data 6...

Page 8: ...o know about using the OneTouch SureStep System is included in this owner s booklet and in the test strip package insert that comes in each box of test strips It is important that you read both this b...

Page 9: ...s not used in the United States except on your doctor s recommendation You can easily determine if the meter has been accidentally reset to the wrong unit of measure Simply turn on the meter The unit...

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Page 12: ...nd Compli cations Trial DCCT This was a long term study of people with type 1 diabetes This study found that you should keep your blood glucose close to the levels of people with out diabetes You can...

Page 13: ...that range is considered clinically accurate when testing with the OneTouch SureStep Meter However results can differ by more than 20 in some situations See Comparing Meter and Laboratory Results for...

Page 14: ...harmful if inhaled or swallowed It may also cause skin or eye irritation Do not use the test strips after the expi ration date printed on the bottle label or more than 4 months after first opening th...

Page 15: ...disposing of used lancets and test strips NOTE Blood glucose monitoring requires the help of a Healthcare Professional Work with your Healthcare Professional to set your own target blood glucose value...

Page 16: ...tteries installed Owner s Booklet Quick Reference Guide OneTouch SureStep Control Solution OneTouch Penlet Plus Automatic Blood Sampler OneTouch FinePoint Lancets Carrying Case Logbook OneTouch SureSt...

Page 17: ...C BUTTON Green Codes the meter changes the meter settings marks control solution test results and scrolls through the memory LENS AREA Contains the meter optics that reads the glucose level Test strip...

Page 18: ...t be face up when you insert the test strip Pink Test Square is where you apply a drop of blood White Pad absorbs the excess blood that may extend beyond the pink test square Do not apply blood direct...

Page 19: ...50 mg dL level and a very high blood glucose 350 mg dL level It also shows an off white shade for new unused test strips Important The sample color dots are only approximate They can give you an indic...

Page 20: ...er To check that all display symbols are working press and hold down the blue power button This display check also appears briefly each time you turn on the meter Call LifeScan Customer Services 1 800...

Page 21: ...ch SureStep Test Strip bottle Example Check that the pink side of the test strip faces up and firmly push the test strip into the test strip holder until it stops Insert the test strip tapered end fir...

Page 22: ...irtually all cases Example Example Replace the two AAA alkaline batteries Clean the meter and test strip holder The meter displays your test result in mg dL or mmol L together with the date and time o...

Page 23: ...ber on the test strip bottle label you may get inaccurate results 1 Press the blue power button to turn on the meter Make sure there is not a test strip in the meter when you turn it on Display Check...

Page 24: ...is code until you change it NOTE If the meter advances past the code number before you are able to change it continue pressing the green button until the code number appears CAUTION Your meter has bee...

Page 25: ...our blood for the first time Every time you open a new bottle of test strips If you drop the meter To check that the meter and test strips are working together properly If your results do not reflect...

Page 26: ...ove a test strip from the bottle and replace the bottle cap Close it tightly Check the expiration date and discard date Do not use the test strips after these dates Compare the color of the confirmati...

Page 27: ...the control solution bottle write the discard date on the label in the space provided The discard date for control solution is 3 months from the date you first open the bottle Check expiration date a...

Page 28: ...t firmly insert the test strip into the meter until it stops you may get an inaccurately low result IMPORTANT Immediately insert the test strip after applying the control solution If you do not insert...

Page 29: ...rk the test result as a control solution result CTL in meter memory Marking the control result prevents it from being included in the 14 and 30 day blood glucose averages Example NOTE Pressing the gre...

Page 30: ...control solution test Understanding Control Solution Results Control solution test results should fall within the printed range on the test strip bottle label If a control solution test result falls...

Page 31: ...performed outside of the temperature range 59 95 F 15 35 C you have applied too much control solution If your control solution result falls outside the printed range repeat the control solu tion test...

Page 32: ...ol Depth Adjustment Knob Cap Depth Settings Depth Indicator Lancing Device Meter OneTouch SureStep Test Strip Sterile Lancet Choose a clean dry work surface Make sure you have all the items needed for...

Page 33: ...rmation dot on the test strip is darker than the Unused color do not use the test strip Make sure the code on the meter display matches the code on the test strip bottle label Do a test with OneTouch...

Page 34: ...cet is seated in the lancet holder CAUTION Never share a lancet with another person Lancets are for single use only Always use a new sterile lancet 2 Carefully remove the lancet s protective cover Rep...

Page 35: ...em thoroughly To increase blood flow to the fingertips massage your hand two or three times from wrist to fingertips 6 Press the blue power button to turn on the meter The display check appears briefl...

Page 36: ...er on the test strip bottle If they do not match press the green C button until the codes match These two symbols will alternate on the display The meter is now ready to perform a test The meter will...

Page 37: ...not use the test strip The result may be inaccurate CAUTION Use a test strip as soon as possible after removing it from the bot tle Prolonged exposure to moisture light or heat can cause inaccurate re...

Page 38: ...ase button If needed gently massage your finger from base to tip to help obtain the needed volume of blood 10 Apply one drop of blood to the center of the pink test square in one of the ways shown Nev...

Page 39: ...r your finger and touch the drop of blood to the center of the pink test square Be careful not to apply too much blood especially if you tend to bleed easily or are taking blood thinning medications T...

Page 40: ...rmation dot you have not applied enough blood to obtain an accurate test You must start over with a new test strip If there is no color or if white patches or streaks appear after you have repeated th...

Page 41: ...the meter is reading your result Your glucose result appears in about 30 seconds Do not remove strip until countdown is com plete The wait may be shorter or longer depending upon the current temperat...

Page 42: ...can quickly check to see if your glucose is very low 50 mg dL or very high 350 mg dL prior to troubleshooting the error message To quickly see if your glu cose is very low 50 mg dL or very high 350 m...

Page 43: ...ureStep meter test result Do not use Color Chart to verify control solution tests 13 Record your test result in your logbook If a test result falls outside of the target range that you and your Health...

Page 44: ...ick carefully follow the lancet and lancing device instructions for safe removal and disposal of used lancets 19 Return the lancing device to its original position following the lancing device instruc...

Page 45: ...o diet exercise medication or stress repeat the test If the result is similar and still outside of your range review Testing Tips for Accurate Results If you get an error message instead of a number a...

Page 46: ...sult is very low 20 mg dL or less and you do not have symptoms of low blood glucose remove the test strip from the meter and look at the con firmation dot on the back of the test strip You should do o...

Page 47: ...color will also be darker than the 350 mg dL sample color dot on the test strip bottle label This indicates very high blood glucose severe hyperglycemia Follow the advice of your Healthcare Profession...

Page 48: ...ay Your meter glucose result should agree with a laboratory result within 20 most of the time under normal conditions A result with in that range is considered accurate when testing with the OneTouch...

Page 49: ...or high relative humidity or some other extreme environmental con dition If you test under these conditions repeat the meter test in a climate con trolled place as soon as possible The operating tempe...

Page 50: ...feel Do I have symptoms of low blood sugar hypoglycemia slurred speech headache tingling of lips cool sweating rapid heartbeat disorientation weakness dizziness fainting hunger nervousness irritabilit...

Page 51: ...so void your warranty Cleaning the Meter CAUTION Use water to clean the meter Do not get water inside the meter case Never immerse the meter or hold it under running water Do not use alcohol glass cle...

Page 52: ...the hole Dry the test strip holder com pletely with a soft cloth or lint free tis sue M A I N T E N A N C E 42 1 Press down at the top end near blue power button of the test strip holder and slide it...

Page 53: ...aterials such as paper towels 4 Slide the test strip holder into the meter press down and push forward at the test strip insertion point until you hear a click Make sure the test strip holder is firml...

Page 54: ...water and dry thoroughly Failure to remove the excess bleach may result in an error message or an inaccurately high result Note Clean the outside of the meter by gently wiping it with a cloth dampene...

Page 55: ...ries and battery removal will not affect test results stored in meter memory However the current time and date will be lost and must be reset each time you change the battery See Changing Meter Settin...

Page 56: ...nges into the slots and press down gently until the tab catches 6 Set the current time and date in the meter as described in Changing Meter Settings M ilp ita s C A 9 4 0 3 5 C 22 2 N o 12 5 R is k C...

Page 57: ...before testing your blood Store your OneTouch SureStep Test Strips in a cool dry place in the original moisture resistant light protected bot tle The storage temperature should not exceed 86 F 30 C D...

Page 58: ...For those problems the meter can detect it may not produce an error message every time the problem occurs When an error message appears note the error number turn off the meter and then resolve the e...

Page 59: ...you continue to get any error message com pare the color of the test strip confirmation dot to the Color Chart on the test strip bottle If the glucose level is very low 50 mg dL or very high 350 mg dL...

Page 60: ...e with an alternate method While awaiting results Compare the color of the test strip confirmation dot to the Color Chart on the test strip bottle label If the glucose level is very low 50 mg dL or ve...

Page 61: ...inserting the test strip into the meter Do not alter the test strips Note If you continue to get any error message compare the color of the test strip confirmation dot to the Color Chart on the test s...

Page 62: ...he meter compare the color of the test strip confirmation dot to the Color Chart on the test strip bottle If the glucose level is very low 50 mg dL or very high 350 mg dL follow the advice of your Hea...

Page 63: ...y heat or cold to the meter Note If you continue to get any error message compare the color of the test strip confirmation dot to the Color Chart on the test strip bottle If the glucose level is very...

Page 64: ...ip confirmation dot to the Color Chart on the test strip bottle If the glucose level is very low 50 mg dL or very high 350 mg dL follow the advice of your Healthcare Professional Make sure the test st...

Page 65: ...y result in an error message or an inaccurately high result Recheck the code number entered in the meter and make sure it matches the code number on the test strip package Note If you continue to get...

Page 66: ...ossible to push the test strip into the test strip holder too fast If this happens the meter displays the Remove Test Strip symbol Remove Test Strip Firmly push the test strip into the test strip hold...

Page 67: ...the code on the bottle See p 16 Result is over 500 mg dL See p 36 IMPORTANT Result from meter memory See p 65 67P SYMBOL WHAT IT MEANS Meter is reading your result See p 31 Meter and or test strip hol...

Page 68: ...ition to the date and time F E A T U R E P R E S E T A L T E R N A T I V E S E E P A G E Set time and date Pacific Standard Any 59 Automatic display of last result On Off 61 Unit of measurement mg dL...

Page 69: ...ess and hold it down to scroll Setting the Date and Time The OneTouch SureStep Meter records the time and date of each glucose test you per form You may have to change the time and date for example wh...

Page 70: ...tes on the display press the blue power button and the year setting will appear on the display Note Calculated 14 day and 30 day aver ages may change if you change the date and time The averages are c...

Page 71: ...button and the display of last result setting will appear Display of Last Result Unit of Measurement The meter is preset to display test results in milligrams per deciliter mg dL the unit of measureme...

Page 72: ...etting Beep Signals The OneTouch SureStep Meter uses beep ing tones to signal certain steps in the proce dure However these beep signals do not mean that the step was performed correctly Three types o...

Page 73: ...our blood glucose test averages If you wish to turn the averages off press the green button The following display will appear No averages will be displayed in memory mode Press the blue power button t...

Page 74: ...rmat setting Date Format The meter is preset to display the date in month day format An alternate day month format is available To change the display of the date to the day month format press the gree...

Page 75: ...cluded in your averages Getting All Results from Meter Memory To get the results stored in the meter s memory 1 Press the blue power button and hold it down for about 5 seconds 2 When the display flas...

Page 76: ...If the test result was marked as a control solution result CTL appears under the result 6 To scroll quickly through the results press and hold the green C button 7 If a test resulted in an error messa...

Page 77: ...ol after you turn on your meter when your last test ended in an error and the meter did not display a glucose result Uploading Memory Data Test results stored in the memory may be uploaded to a person...

Page 78: ...onths when doing two tests per day Result Range 0 500 mg dL 0 27 8 mmol L Higher results are virtually always displayed as HI Display Liquid crystal Blood Source Whole blood Calibration Plasma equival...

Page 79: ...s express or implied including any implied warranty of merchantability or fit ness for a particular purpose Three Year Warranty The OneTouch SureStep Meter has a full 3 year warranty from the date of...

Page 80: ...C button until the code number on the meter matches the code number on the test strip bottle P E R F O R M I N G A T E S T 4Firmly push the test strip into the test strip holder with the tapered end f...

Page 81: ...tely blue for an accu rate test If any white patches or streaks appear on the blue confirmation dot you have not applied enough blood for an accurate test You must start the test over with a new test...

Page 82: ...ter settings 58 64 Marking control solution result 19 Changing Batteries 44 46 Code numbe14 Meter settings 58 64 Checking Code number 16 26 Confirmation dot 18 30 System 15 21 Cleaning Contact points...

Page 83: ...1 Format 64 Discard date Control solution 4 17 Test strip 4 16 23 27 Display Of last result 61 Screen 7 Symbols 10 12 E Error message Instead of blood glucose result 32 33 35 Troubleshooting 48 57 Exp...

Page 84: ...ying blood 28 29 Applying control solution 17 Plasma glucose value 35 38 Power button 7 16 25 Precautions 4 5 R Result 14 and 30 day averages 19 63 Blood glucose 31 33 Comparing to lab result 3 38 40...

Page 85: ...ions of the Diabetes Control and Complications Trial Position Statement Diabetes Care 1988 21 Supplement 1 S88 S90 2 Wickham NWR et al Practical Diabetes Vol 3 No 2 1986 100 3 Cohen FE et al Diabetes...

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Page 88: ...5 789 255 5 922 530 5 968 836 6 045 567 6 156 051 6 197 040 6 335 203 and 6 491 870 Use of the monitoring device described herein is protected under the U S patents 4 935 346 Purchase of the monitori...

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