Lifescan SureStep User's Manual
Contents
1. p LIFESCAN Shows your test results and symbols that guide you through the test LENS AREA Contains the meter optics that read the glucose level Test strip holder covers the lens area Back SERIAL NUMBER Example BATTERY COMPARTMENT Holds two AAA alkaline batteries L SureStep a C3 SureStep BLOOD GLUCOSE METER Toll free customer service UNITED STATES pee English 1 800 227 8862 e Espa ol eo 1800 381 7226 N CANADA 5 1 800 663 5521 e na cs aia ici a i LIFESCAN Er flnn delen carpa Milpitas CA95oS NT OLIFESCAN INC 1998 E AWO52 178018 Mad USA B1 C BUTTON Green Codes the meter changes the meter settings marks control solution test results and scrolls through the memory POWER BUTTON Blue a Turns the meter on and off accesses the memory and navi gates through the set up mode CONTACT POINTS Sense the position and orientation s of the SureStep Test Strip TEST STRIP HOLDER Closed Test Strip Insertion Point The cover protects the lens area and the base holds the SureStep Test Strip m gt D z z o LEARNING SureStep Test Strips When blood is applied to the pink test square it is absorbed and a chemical reaction takes place A blue colour forms in the confirmation White Tip is inserted int2. 8 6 8 mmoll 406815A 06 98 Example When you can do three control solution tests in a row that are within the control range you are ready to test your blood e I m e Z z o 17 o zZ 4 O W I o Control Solution Range If test results fall outside the expect ed range repeat the test Results that fall outside the expected range may indicate the system is not working properly Some possi ble causes are Procedural error Expired or contaminated control solution m Test strip code and meter code do not match Dirty meter or test strip holder Test strip deterioration Meter malfunction Control solution that is outside of the temperature range 15 35 C 59 95 F If you are unable to resolve the problem call the LifeScan Customer Care Line at 1 800 663 5521 U S A 1 800 227 8862 TESTING YOUR BLOOD Detailed Test Procedure Choose a clean dry work surface Make sure you have all the items needed to test m N z o SureStep Sterile Meter Test Strip Lancet Ejection Cocking Control Cap Release Button Depth Settings e Depth Adjustment Knob Penlet Plus Adjustable Blood Sampler Depth Indicator 19 TESTING Getting a Drop of Blood IMPORTANT Getting an adequate drop of blood is one of the most important steps in getting an accurate result CAUTION To reduce the chance of infection m N
3. Before testing the confirmation dot should be off white DO NOT use test strip if confirmation dot is darker than the colour of an unused test strip shown on the Colour Chart included with the test strip package m Use each test strip immediately after removing it from the package Replace the test strip bottle cap immediately after removing a test strip and close the cap tightly Never transfer test strips to a new bottle or any other container DO NOT use bleach or products containing bleach with the test stri ps For reliable results use only SureStep Test Strips made by LifeScan 5 m gt D z z o LEARNING Display Symbols The SureStep Blood Glucose M eter uses symbols to guide you through atest and to help you determine if something is wrong with your test strip or meter To check that all display symbols are working press and hold down the blue power button All symbols should appear This display check will also appear briefly each time you turn on the meter Call the LifeScan Customer Care Line at 1 800 663 5521 U S A 1 800 227 8862 if any segments are missing Display Check Meter Memory Result Your Code Number The number on SureStep Meter stores up to 150 the display must match the code 4 blood glucose or control solution number on your SureStep Test z test results with their times and Strip package It must be checked 5 dates in its memory Every time you eve
4. In addition to these factors there are other abnormal conditions that can affect your results 1 Extremes in hematocrit the amount of red blood cells in the blood can affect test results Very high hematocrits above 60 and very low hematocrits below 25 can cause false results 2 Severe dehydration and excessive water loss may cause false low results Severe dehydra tion which may lead to many serious medical complications can be caused by Vomiting and diarrhea Prescription drugs e g diuretics m Inability to recognize or respond to thirst sensations Uncontrolled diabetes Shock If you believe you are suffering from severe dehydration consult a health care professional immediately Recommendations for Better Diabetes Control Follow the advice of your health care professional Follow the exercise and meal plans recommended by your healthcare professional Takeinsulin or diabetes medication at your scheduled times Keep in touch with your emotional and physical condition Stress or ilIness can affect diabetes Watch for symptoms of hypo glycemia low blood glucose and hyperg ycemia high blood glucose Review your logbook of test results with your healthcare professional regularly References 43 1 American Diabetes Association position statement on the Diabetes Control and Complications Trial 1993 2 Clarke W L et al Diabetes Care Vol 10
5. 22 Step 2 Cock the Penlet Plus Sampler Slide the ejection cocking control backward until it clicks If it does not click the Penlet Plus Sampler may have been cocked when the lancet was inserted Step 3 Wash Your Hands Use warm soapy water Rinse and dry hands thoroughly To increase blood flow to your fingertips massage the hand from the wrist to the fingertip two or three times without touching the puncture site Step 4 Lance Your Finger Choose a spot on the side of a different finger each time you test Repeated punctures in the same spot may cause soreness and calluses Hold the Penlet Plus Sampler firmly against the side of your finger Press the release button Greater pressure of the device against the finger will also cause a deeper puncture 23 m o z o TESTING Gently massage your finger to obtain Step 5 Remove the Lancet the required blood volume Proceed Remove the cap Twist it counter with your blood glucose test clockwise 24 Optional To replace the protective Always use caution when removing disk on the lancet place the disk on the lancet Point the lancet down a hard surface and push the exposed and away from you Push forward tip into the protective disk on the ejection cocki ng control and eject the lancet directly into y a container for sharp objects LT DE i Ss Return the eje
6. Code numbers are used to calibrate the SureStep Test Strip with the SureStep Meter for accurate results You must code the meter before using it for the first time You must check the code every time you change to another package of test strips Check that the code number on the display matches the code number on the test strip package Caution If the code numbers do not match you may get inaccurate results 10 Three Easy Steps to Coding Step 1 Turn On the Meter Press the blue power button After the display check the result from either your last blood glucose test with date or your last control solution test will D HAAN dog 1 26 e BBP t Example If you are turning on the meter for the first time will appear on the display Next the meter code will appear for a few seconds CODE Example Step 2 Check the Code Numbers The code number on the test strip package will range from 1 to 21 If the number on the display matches the code number on the SureStep Test Strip package begin testing If the two code numbers do not match follow Step 3 to code the meter Example Step 3 Code the Meter After the CODE symbol appears press the green C button Continue pressing until the code number on the display matches the code num ber on the test strip package Green C Button v LIFESCAN Example The code is now set for
7. To change the batteries turn off the meter and turn it over Follow these steps Step 1 Remove the Battery Door Squeeze the tab and lift up Step 2 Remove the Old Batteries Step 4 Close the Battery Door Use your fingers or gently tap the Insert the two hinges into the slots meter on the palm of your hand and press down until the tab catches Never tap the meter against a hard surface Note Remember to reset the time and date after replacing Step 3 Insert New Batteries the batteries Insert two new AAA alkaline batteries matching the end of each battery with the signs inside the meter 53 m gt z 9 m SETTINGS CHANGING METER SETTINGS Set Up Mode The SureStep M eter has been pre set to meet the needs of most users In addition to setting the time and date Be sure you want to change these settings before entering the set up mode to avoid having meter there are six features you can change settings that do not meet your needs FEATURE PRE SET ALTERNATIVE Set time and date Pacific Standard Any Automatic display On Off of last result Unit of mmol L mg dL measurement Beep signals On Off during testing 14 and 30 day On Off test averages Time format AM PM 24 hour Date format Month Day Day Month 54 Entering Set Up Mode 1 Make sure the meter is off 2 Press and hold down the gr
8. and when the meter is in set up mode on the beep signal feature 60 In set up mode when you move to the beep signal feature the meter will sound a three tone beep and flash this message Un If you want the meter to operate without beeps press the green C button to turn off the beep signals Thefollowing display will appear OFF You will hear a three tone beep mark control solution test results when GFF is displayed Press the This will keep them from being blue power button to move to included in your blood glucose test the 14 and 30 day test averages averages see pages 16 and 17 HS If you wish to turn the averages 14 and 30 Day Test Averages off press the green C button The The meter is pre set to display following display will appear 14 day and 30 day averages of m your blood glucose test results in memory mode 4 ec m 5 IH dH n un No average will be displayed in idy memory mode Press the blue power button to move to the To ensure accurate 14 and 30 day time format setting blood glucose test averages you must 61 SETTINGS Time Format The meter is pre set to display the time in the 12 hour AM PM format An alternative 24 hour time format is available man PM ed Press the green C button if you wish to change the setting Press the blue power button to move to the date format setting Date Format The meter is pre set to display the date in the month day format Press the gr
9. Department Remember to complete and mail the Warranty Registration Card Important phone numbers LifeScan Customer Care Line CANADA 1800 663 5521 Healthcare Professional Diabetes Educator Meter Serial Number U S A 1 800 227 8862 Pharmacist Other CAUTION Before using any product to test your blood glucose blood sugar read all instructions and practice the test Do all quality control checks as directed and consult with a diabetes healthcare professional These recom mendations apply to all blood glucose monitoring systems and are supported by the Diabetes Educator Section of the Canadian Diabetes Association IMPORTANT If you have followed the tips to ensure accuracy and your blood glucose results are still out of range call your healthcare professional The SureStep System contains many small parts test strip holder battery door batteries lancets control solution vial test strips test strip bottle cap etc Keep the system out of the reach of small children because these parts may be dangerous if swallowed If using a 1096 bleach solution to disinfect the meter be sure to completely remove any bleach from the meter and test strip holder with a cloth dampened with water Bleach will react with the test strips and cause inaccurate results TABLE OF CONTENTS LEARNING THE SYSTEM 1 SureStep Blood Glucose M eter 3 SureStep Test Strips N 4 Disp
10. cold to the meter or test strips 1 The meter test strip holder E r 5 lens area and contact points are dirty or v 1 Clean refer to pages 47 51 2 The test strip holder is not fully in place or 71 2 Slidethe test strip holder into the meter until it is completely inserted m Qo gt O m 7 POSSIBLE CAUSE 3 The test strip was partially inserted before turning the meter on WHAT TO DO 3 Remove test strip and turn meter off Turn meter on then reinsert test strip when insert test strip symbol appears A possible failure has occurred in the meter 72 Turn meter on Before testing check that the code on your meter matches the code on your test strip package If E 6 continues call the LifeScan Customer Care Line at 1 800 663 5521 U S A 1 800 227 8862 SPECIFICATIONS Performance Characteristics Calibration Plasma equivalent Power Supply Two AAA Hematocrit Range 25 60 alkaline batteries v v m Q a O gt e z o Size 8 9 cm x 6 1 cm x 2 0 cm Battery Life Approxi mately 18 Weight 107 7 grams with batteries months when doing two tests a day Operating Temperatures 10 35 C Result Range 0 27 8 mmol L 50 95 F 0 500 mg dL Higher results u are displayed as Hi Operating Humidity Range 10 90 relative humidity Display Liquid crystal noncondensing Blood Source Whole blood Memory 150 blood
11. glucose and control solution tests 73 WARRANTY Guarantee and Warranty 30 Day Money Back Guarantee If you are not fully satisfied with the SureStep System a full refund may be obtained by callinga LifeScan Customer Services Representative at 1 800 663 5521 Canada within 30 days of pur chase After calling LifeScan you will need to return the SureStep Meter and a copy of your receipt to receive a refund 74 Six Year Warranty If at any time during the first six years after purchase the meter does not work for any reason except for obvious abuse LifeScan will replace it with a new meter or equivalent product free of charge The Warranty Policy applies only to the original purchaser of this meter and does not include the batteries supplied with the meter Please complete the Warranty Registration Card and mail it to LifeScan The SureStep Meter has a full six year warranty from the original date of purchase Write your date of purchase here The Warranty Policy does not apply to the performance of the SureStep Meter when used with any test strip other than SureStep Test Strips from LifeScan or when the SureStep Meter or Test Strips are modified in any way Before you return your meter or any product first call your LifeScan Customer Services Representative at 1 800 663 5521 Canada for instructions This warranty is in lieu of all other warranties express or implied in
12. the test strip if the con firmation dot is darker than the colour of an unused test strip on the Colour Chart 2 After testing Directly after reading a meter result you can compare the colour of the test strip confirmation dot with the colours on the chart The colour of the confirmation dot will either match one of the colours on the chart or fall between two colours When the colour of the blue dot falls between two colours your blood glucose level is between the values printed next to the two colours This comparison will give you a rough estimate of your blood glucose level The Colour Chart is to be used as an additional check to confirm a meter read ing It is NOT a replacement for a SureStep Meter test 35 Note If your Colour Chart reading and meter result do not agree and do not reflect how you feel follow the testing tips for accuracy on pages 40 and 41 Do not use the Colour Chart with control solution tests m o d Z e RESULTS UNDERSTANDING YOUR RESULTS Overview Long Term Diabetes Findings In 1993 the National Institutes of Health concluded an exten sive longterm study of people with Type 1 diabetes This study called the Diabetes Control and Complications Trial DCCT found that by keeping your blood glucose close to the levels of people with out diabetes you can reduce the risk of complications involving the eyes kidneys and nervous system by approximatel
13. will start flashing Press and release the green C button to advance one minute To move faster hold the green C button down With the correct minutes on the dis play press the blue power button and the year setting will appear on the display OC nM CHAM 2O CnAM 9 50 9 502 Note When the time and date are changed the calculated values for the 14 day and 30 day averages may change These averages are calculat ed from the results obtained during the 14 or 30 days preceding the cur rent time and date setti ngs Setting the Year Setting the Month With the year on the display press Press and release the green C button and release the green C button to until the correct month appears To advance one year To move faster move faster hold the green C button hold the green C button down down With the correct month dis played press the blue power button and the day segment will start flashing i m d z o o With the correct year on the display press the blue power button and the NE ru month and day will appear month day format is default on the display with the month segment flashing 57 SETTINGS Setting the Day Press and release the green C button until the correct day appears To move faster hold the green C button down With the correct day on the display press the blue power button and the display of last result setting will appear Display of Last R
14. Colour Chart see pages 34 and 35 If you have symptoms that match your results or if you continue to get results that fall below 3 3 mmol L or above 13 3 mmol L follow the treatment advice of your healthcare professional i Kahn R and Weir G Joslin s Diabetes Mellitus ii Krall L P and Beaser R S Joslin Diabetes Manual 13th ed Philadelphia Lea and Febiger 1994 489 Philadelphia Lea and Febiger 1989 261 263 32 Record your test results in your Press the blue power button to turn LifeScan logbook The logbook off the SureStep Blood Glucose m allows you to keep a record of your Meter To save energy the meter test results along with information automatically turns off three ol on your meals and medication minutes after it displays your test result LIFESCAN i SureStep 33 TESTING Optional Colour Chart A Colour Chart is included with each package of SureStep Test Strips It is useful as an additional check that your meter and test strips are working properly The Colour Chart is NOT a replacement for a SureStep Meter test The chart shows four shades of blue each corresponding to a blood glucose level It also shows an off white shade for new unused test strips Use the Colour Chart in the following two ways 34 1 Before testing Compare the confirmation dot on the back of the new test strip to the shade marked unused on the chart Do not use
15. NADA 1 800 663 5521 U S A 1 800 227 8862 LEARNING THE SYSTEM The SureStep Diabetes Blood Glucose Monitoring System is the next advance in the self monitoring of blood glucose The SureStep System is for people with diabetes who need to check the level of sugar glucose in their blood A drop of blood is taken from the finger and placed on a SureStep Test Strip which is then inserted into the SureStep Blood Glucose Meter The meter measures the blood glucose level and displays the result on average in 30 seconds The system is calibrated to give a plasma value the measurement used by most clinical laboratories Easy to understand symbols guide you through the test procedure and help you if any problems arise SureStep Brand Test Strips arethe only test strips that have been specifically designed devel oped and tested for use with the SureStep Meter to ensure consis tent quality and accuracy For reliable results and to maintain the manufacturer s complete ser vice support and warranty use only SureStep Brand Test Strips made by LifeScan m gt I z z o pr e an easi O rn we nopo m y 00000 IER doigaung uu3533n sni cm Extra Space for Diabetes Supplies SureStep Blood Glucose Meter DATA PORT Allows you to transfer the information stored in the meter s memory to a com puter to view analyze and print DISPLAY Front
16. NGES FOR PEOPLE WITHOUT YOUR TARGET DIABETES mmol L RANGES mmol L Before breakfast 3 9 5 8 Before lunch or dinner 3 9 6 1 1 hour after meals Less than 8 9 2 hours after meals Less than 6 7 Between 2 and 4am Greater than 3 9 39 D m o Cc F o RESULTS Testing Tips to Ensure Accuracy If you have a test result that falls outside of your target range and you cannot link it to diet exercise med ication or stress repeat the test If the result is similar and still outside of your range try these troubl eshoot ing steps Before Testing Wash your hands m Use a new sterile lancet m Check the expiration date on the test strip package If it has passed discard the unused test strips and open anew package When using test strips from a bottle discard any remaining test strips four months after first opening 40 m Make sure the confirmation dot on the unused test strip is not darker than the colour of an unused test strip shown on the Colour Chart Make sure the code on the meter matches the code on the test strip package Do atest with SureStep Glucose Control Solution to verify that the test strip and meter are work ing properly m Make sure the meter test strip holder lens area and contact points are clean Follow instruc tions on pages 47 51 After Testing Make sure you applied enough blood to the test strip by inspect ing the test strip con
17. No 5 1987 622 628 3 Surwit R S and Feinglos M N Diabetes Forecast 1988 April 49 51 4 Sacks D B Carbohydrates Burtis C A and Ashwood E R ed Tietz Textbook of Clinical Chemistry Philadelphia W B Saunders Company 1994 959 5 Krall L P and Beaser R S Joslin Diabetes Manual Philadelphia Lea and Febiger 1989 138 6 LifeScan data on file 7 Wickham N W R et al Practical Diabetes Vol 3 No 2 1986 100 8 Cohen F E et al Diabetes Care Vol 9 No 3 1986 320 322 9 Atkin S H et al Fingerstick glucose determination in shock Annals of Internal Medicine Vol 114 1991 1020 1024 D m o Cc F o gt x O W RECALLING RESULTS FROM METER MEMORY The SureStep Blood Glucose M eter is pre set to display your last test result automatically when you turn on the meter The meter stores your 150 most recent blood glucose or control solution test results with alternating date and time in its memory When the memory is full the oldest result is dropped as the newest is added It also provides you with 14 and 30 day averages of your blood glucose test results Results marked as control solution test results will not be included in your averages 44 Using the Meter for the First Time The first time you turn on your meter the following symbol will appear briefly showing that there are no test results in the memor
18. ONE TOUCH Sur e Ste p Diabetes Blood Glucose Monitoring System Syst me de surveillance de la glyc mie Owners Booklet Manuel du propri taire a NOWVITH d LIFESCAN 150 Test Memory GARDE MAINTENANT afohmonsfohmon company 150 tests en m moire une filiale de Fohurnafohuen ONE TOUCH COMPLETE BLOOD GLUCOSE MONITORING SYSTEM Owner s Booklet The SureStep System is intended 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 Welcome to LifeScan Congratulations Y ou ve chosen a product made by LifeScan a leading company in providing products to help you manage your diabetes SureStep blood glucose monitoring products are widely available without a prescription Blood glucose monitoring plays an impor tant role in controlling your diabetes A long term study showed that keeping blood glucose levels close to normal can reduce the risk of complications by up to 6096 The results you get with the SureStep System can help you and your healthcare professional monitor and adjust your treatment plan to gain better control of your diabetes Everything you need to know about using the SureStep System is included in this booklet If you have any ques tions please feel free to call the toll free numbers to speak with our Customer Services
19. and date will alternate See pages 55 58 to learn how to set the time and date The meter displays results from 0 to 27 8 mmol L 0 500 mg dL In virtually all cases above 27 8 mmol L 500 mg dL the meter reads H1 Note Your meter is desi gned to give accurate results at temper atures from 10 to 35 C 50 95 F At the higher end of this tempera ture range the test time may be as short as 15 seconds At the lower end of this temperature range the test time will be extended The SureStep System is calibrated to give plasma values Because most clinical laboratories measure plasma glucose the SureStep 31 m o d z to TESTING System enables you to more directly results See pages 37 and 38 to learn compare meter results with lab how to compare meter and lab results IMPORTANT When proper procedures are followed the meter will dis play H in virtually all cases when your result is above 27 8 mmol L 500 mg dL This indicates very high blood glucose severe hyperglycemia Low and High Blood Glucose Test results below 3 3 mmol L 60 mg dL mean low blood glucose hypoglycemia Test results greater than 13 3 mmol L 240 mg dL mean high blood glucose hyperglycemia If you get results below 3 3 mmol L or above 13 3 mmol L and you do not have symptoms that match your results repeat the test following the guide lines on pages 40 and 41 to ensure testi ng accuracy You may also use the
20. cations LifeScan Customer Care Line Ligne InfoSoins Monday Friday 9am 8em Eastern Time 6am 5pm Pacific Time Du lundi au vendredi de 9 h 20 h heure de l Est et de 6 h 17 h heure du Pacifique Canada 1 800 663 5521 U S A E U 1 800 227 8862 LIFESCAN IAD UOI tees rues em ee m dicaux LifeScan Canada Lt e V5C 6C6 AW 050 906 01A AW 05090601A LifeScan Inc 1999 Milpitas CA 95035 8 99 www LifeScan can com
21. cluding any implied warranty of merchantability or fitness for a particular purpose 75 gt D D gt lt COMPLIANCE REGULATORY INFORMATION The SureStep Blood Glucose Meter complies with the following standards m CAN CSA C22 2 No 601 1 M90 Medical Electrical Equipment Part 1 General Requirements for Safety Complies with UL 2601 1 CAN CSA C108 6 M91 CISPR 11 1990 Limits and Methods of Measurement of Electromagnetic Disturbance Characteristics of Industrial Scientific and Medical ISM Radio Frequency Equipment Complies with Canadian ICES 001 a Internally powered equipment No patient applied parts a This unitis not suitable for use in the presence of a flammable anesthetic mixture with air oxygen or nitrous oxide 76 CODING THE METER Before testing make sure the meter is coded correctly LIFESCAN Example Press blue Meter automatically power button displays last test result with date LIFESCAN CODE 7 i Example Example Code number is Press green C button automatically until code number on displayed meter matches code number on test strip package 3 STEP TEST PROCEDURE Press blue power button and apply blood to pink test square Check confirma tion dot on back of test strip Firmly insert test strip pink side up until it comes to a complete stop and r
22. ction cocking control to the middle position Replace the cap m o Z o 25 TESTING How to Test Your Blood Next the code number appears It Press the blue power button must match the code number on the SureStep Test Strip package If it does not match change the meter code number following the instruc tions on pages 10 and 11 Example Example 26 These symbols will alternate on Step 1 Apply Blood to the the display Test Strip m Apply a drop of blood to the center z Note Do not add more blood to the A first drop Adding more blood may Apply blood to Insert test strip S of the pink test square give false results test strip into meter Front Back The meter is ready for a test You a have two minutes to insert the test O strip before the meter automatically Pink Test turns off Sate White Confirmation Pad Dot 27 TESTING You can apply blood to the pink test square in one of two ways 1 Turn the test strip over and dab OR the pink test square to the finger 2 Hold the test strip under your You can touch the test strip The finger and touch the drop of blood pink test square will quickly absorb to the pink test square the blood and the confirmation dot will begin changing colour SN b 6 28 You have applied too m
23. e test strip package A colour that matches or is darker than the 19 4 mmol L 350 mg dL colour on the chart indicates a high blood glucose level Follow the treatment advice of your healthcare professional ERROR Era POSSIBLE CAUSE 1 Not enough blood was applied to the test strip or WHAT TO DO L Repeat the test with a new test G strip Apply a larg er drop of blood to the pink test Confirmation square and verify Dot that the confirma tion dot on the back of the test strip has turned completely blue 2 The test stri p has been altered exposed to air or has passed its expiration date 69 2 Check the expiration date on your test strip package Do not store test strips outside of the original bottle Do not alter test strips m Qo gt O m 7 ERROR POSSIBLE CAUSE WHAT TO DO 1 The test strip 1 Do not remove the test strip E r j was removed until the meter displays the or partially result removed before the result was displayed or 2 The meter 2 Clean meter contact points contact points are dirty Note If more than two minutes have passed since you applied blood to the test stri p repeat the test with a new test strip 70 ERROR POSSIBLE CAUSE The meter is not within the Er 4 temperature range of 10 35 C 50 95 F WHAT TO DO Allow the meter to warm or cool slowly before performing another test Do not apply heat or
24. ead result 30 second aver age test time o c ie A D m TI m D m Z m W O Z m tc Li LL LL as x Q 5 O BLOOD APPLICATION How you can be sure that you have applied the right amount of blood Front Back 1 A 09 Pink Test Square White Confirmation Pad Dot Enough Blood l Front Back Not Enough Blood Ole e Back Too Much Blood 4 4 L Front 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 directly onto the white pad Confirmation doton back of test strip is where you check to confirm proper blood application Apply a drop of blood to the pink test square on the front of the test strip The confirmation dot on the back should be completely blue for an accurate test 78 If any white patches or streaks appear on the blue confirmation dot you have not applied enough blood for an accurate test Y ou must start the test over with a new test strip to avoid false low results If there is no white visible on the white pad you have applied too much blood You must start the test over with anew test strip to avoid false high results Be careful not to apply too much blood especially if you tend to bleed easily or are taking blood thinning medi
25. een C button 3 Press and release the blue power button while holding the green C button 4 Release the green C button Green C Button Blue Power Button Each setting flashes on the display until you press the blue power button to move to the next feature While it flashes the setting may be changed by 55 pressing the green C button After the last feature is displayed the meter turns off when you press the blue power button To move quickly through the features press the blue power button repeatedly or press and hold it to scroll Setting the Time and Date The SureStep Meter has an inter nal clock that will record the time and date of each test you perform You may need to change the time setting in your meter to have the correct time and date appear with your test result You also will need to reset the time whenever there is a change to or from daylight saving time The accuracy of your o m z o o SETTINGS test results will not be affected if you do not set the clock to the cor rect time The time and date must be reset every time the batteries are replaced Setting the Time To set the time enter the set up mode The display will show the time with the hour flashing Press and release the green C button to advance one hour To move faster hold the green C button down With the correct hour on the display press the blue power button and the minutes
26. een C button to change the display of date to the day month format Press the blue power button to turn off the meter Exiting the Set Up Mode You may exit the set up mode at any time by simply pressing the blue power button and holding it down until the display is blank 63 m Es d z o 7 SOLVING PROBLEMS When any of the following symbols or error messages appear there may be a problem with the meter test strip or the way you are doing the procedure These messages help to identify certain problems but do Helpful Messages SYMBOL t MESSAGE The test strip was not fully inserted 64 not appear in all cases when a prob lem has occurred In most cases a problem is easy to solve Assis tance is available from the LifeScan Customer Care Line at 1 800 663 5521 U S A 1 800 227 8862 WHAT TO DO Push the test strip in firmly until it stops SYMBOL MESSAGE WHAT TO DO 1 The test strip 1 Remove the test strip and was inserted then reinsert after this before the symbol appears meter was t turned on or before the insert test strip symbol appeared or 2 The test strip 2 Reinsert the was inserted test strip tip first incorrectly or with the pink side facing up 65 SYMBOL MESSAGE WHAT TO DO 3 The test strip 3 Reinsert test was inserted strip slowly d too quickly EE If the symbol is Replace the batteries constan
27. en more than 15 minutes apart the two tests could have very different results 37 D m on Cc F 4 o RESULTS 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 3 9 mmol L higher than that of a venous sample blood drawn from a vein used for a laboratory test Therefore it is best to fast for eight hours before doing the compar ison tests Factors such as a high or low hematocrit amount of red blood cells in the blood or severe dehydra tion loss of body fluid may also cause a meter result to be different from a laboratory result For more detail see pages 41 and 42 38 Expected Test Results Target Range Your test results will vary some what from test to test Blood glu cose levels change throughout the day The types and amounts of food you eat your activity and stress levels and how much insulin or other medication you take affect your blood glucose levels If you are controlling your diabetes well your test results should fall within a personal target range recommend ed by your healthcare professi onal Once you have established your tar get range you will be able to detect when your results are high or low and can take action with advice from your healthcare professional GLUCOSE RA
28. er Note You can clean the outside of the meter by lightly wiping it with a damp cloth Turn on the meter If this symbol appears after clean Changing the Batteries ing the meter check to see if you inserted the test strip holder com pletely and securely The test strip holder may be out of position See pages 67 72 for error descriptions Er 5 M Note If using a 1096 bleach solu tion this message may indicate that you have not completely removed the bleach residue on the grey area of the inside of the test strip holder cover Wipe with a cloth dampened with water and dry thoroughly The SureStep Blood Glucose Meter comes with two AAA alkaline batteries already installed When this symbol appears 2 Z m m z gt z 9 m the batteries are low and you should replace them as soon as possible The meter will still provide accurate test results with low batteries If the symbol starts 51 MAINTENANCE flashing the batteries are now dead and the meter will not operate You will not be able to do a test You should replace both batteries immediately with new AAA alkaline batteries Do not use rechargeable batteries Note Low batteries dead batteries and battery removal will not affect the test results stored in the memory However the time and date must be reset every time the batteries are replaced See pages 55 58 to learn how to set the time and date
29. esult The SureStep Meter is pre set to display your last test result automat ically when you turn on the meter tn 58 If you wish to turn off the automatic display of your last result press the green C button This symbol will flash Q OFF indicating that the automatic display is turned off Then press the blue power button to move to the unit of measurement setting Unit of Measurement If you wish to change the unit of measurement to mg dL press the green C button This symbol will flash on the display The meter is pre set to display test results in millimoles per litre mmol L You have the option to select milligrams per decilitre mg dL the unit of measurement used in the United States The mmol L results include a decimal mg l point but mg dL results do not o m d z 9 o Press the blue power button to move to the beep signals setting mmol L 59 SETTINGS Beep Signals The SureStep Blood Glucose M eter uses beeping tones to signal various steps in the meter procedures However these tones do not indicate that the procedures are being per formed correctly The meter is pre set to emit three different beep signals 1 A single short beep signals each step in the test procedure 2 A single long beep accom panies error messages a Hi result and certain mistakes in doing the test procedure 3 A three tone beep sounds when the meter displays a test result
30. ever share a lancet with another person m Always use a new sterile LifeScan Lancet Lancets are for single use only m Do not use lancet if protective disk has been removed or damaged m The Penlet Plus Sampler should be used by only one person m Avoid getting hand lotion oils dirt or debris in or on the lancets and the Penlet Plus Sampler m For assistance call the LifeScan Customer Care Line at 1 800 663 5521 U S A 1 800 227 8862 20 Step 1 Insert a Lancet into the Penlet Plus Adjustable Blood Sampler Remove the Penlet Plus Cap by twistingit counterclockwise Insert alancet into the lancet holder Push down firmly until the lancet is fully seated in the holder Do not twist the lancet To avoid contamination and to prevent the cap from rolling away set the cap down on a flat surface with its small hole pointing up While the lancet is in the Penlet Replace the Penlet Plus Cap Turn Plus Sampler twist off the protective the cap clockwise until it is snug disk Make two full turns to ensure but not overly tight that the lancet separates from the ie m o pa o protecti ve di sk Ae Wm m MAL 21 TESTING Adjust the puncture depth setting if necessary Twist the knob counter clockwise toward the smaller bumps for a shallower puncture Twist the knob clockwise toward the larger bumps for a deeper puncture TA
31. firmation dot to be certain it turned com pletely blue Make sure you did not apply too much blood to the test strip You have applied too much blood if there is no white visible on the white pad Directly after the meter displays a result compare the colour of the test strip confirmation dot with the Colour Chart on the test strip package see pages 34 and 35 IMPORTANT If you have followed the tips to ensure accuracy and your blood glucose results are still out of range call your healthcare professional Health Conditions Causing Out of Range Results If you are getting results outside your range of expected blood glucose levels and you are certain that the SureStep Meter and SureStep Test Strips are working together properly ask yourself the follow ing questions How do feel Do have symptoms of low blood glucose hypoglycemia slurred speech headache tingling of lips cool sweating rapid heartbeat disorientation weakness dizziness fainting hunger nervousness irritability or tremors 41 D m o Cc F o RESULTS Do have symptoms of high blood glucose hyperg ycemia fatigue dry mouth and skin increased thirst or hunger blurry vision increased urination rapid deep breathing or a fruity smell to the breath What have eaten How much have exercised Am ill common cold flu etc Havel been under stress lately
32. fter applying has turned completely blue to control solution insert the test strip ensure you have applied enough firmly into the test strip holder control solution pink side up until it comes to a complete stop LIFESCAN e I m e Z z o 15 o O Lu I o The control solution result appears on average in 30 seconds LIFESCAN Example Note Do not use the Colour Chart to verify control solution tests 16 Step 4 Mark the Test Result as a Control Solution Test You must mark the test result as a control solution test result so that it will appear in the memory as a control solution test result and not be included in your 14 and 30 day blood glucose test averages Simply press the green C button while the test result is on the display First Cet will replace the test result on the meter display Then the result will again appear on the display with Cet CEL Example nn Wu mmol L roi L CL If you accidentally mark a blood Compare the control solution glucose test result as a control test result with the control range solution test result just press printed on the SureStep Test the green C button to delete Strip package the fet marker Record control solution tests in your logbook by placing a C next to the result to indicate a control solution test SureStep Control Range
33. lay Symbols 6 CODING THE METER CODE Three Easy Steps to Coding 10 CHECKING THE SYSTEM SureStep Glucose Control Solution 12 Control Solution Test 12 Control Solution Range 18 TESTING YOUR BLOOD ex Detailed Test Procedure 19 Getti ng a Drop of Blood 20 How to Test Your Blood 26 Optional Colour Chart 34 LifeScan Customer Care Line CANADA 1 800 663 5521 U S A 1 800 227 8862 UNDERSTANDING YOUR RESULTS Overview 36 Comparing Meter and Laboratory Results 37 Expected Test Results Target Range 38 Testing Tips to Ensure Accuracy 40 Health Conditions Causing Out of Range Results 41 Recommendations for Better Diabetes Control 43 RECALLING RESULTS FROM METER MEMORY Q Using the Meter for the First Time 44 Recalling All Results in Meter Memory 45 Uploading Memory Data 46 CARING FOR YOUR METER General Care 47 Cleaning the Meter 47 Changing the Batteries 51 LifeScan Customer Care Line CANADA 1800 663 5521 U S A 1 800 227 8862 CHANGING METER SETTINGS Set Up Mode 54 Entering Set Up Mode 55 Setting the Time and Date 55 Display of Last Result 58 Unit of Measurement mmol L or mg dL 59 Beep Signals 60 14 and 30 Day Test Averages 61 Time Format 62 Date Format 62 Exiting the Set Up Mode 63 SOLVING PROBLEMS Helpful Messages 64 Error Messages Er 1 Er6 67 SPECIFICATIONS Performance Characteristics 73 Guarantee and Warranty 74 QUICK REFERENCE GUIDE 77 LifeScan Customer Care Line CA
34. o the meter The side where you apply blood must 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 directly onto the white pad White Tip Pink Test Square FRONT White Pad 4 dot on the back of the test strip and is read by the meter to determine the blood glucose level the darker the colour the higher the blood glucose level BACK Black Tip G Confirmation Dot Black Tip helps the meter detect that the strip has been insert ed properly Confirmation Dot on the back of the test strip is where you check to confirm proper blood applica tion When it turns completely blue enough blood has been applied for an accurate test IMPORTANT TEST STRIP INFORMATION Contact with air moisture and light can cause false results Keep test strips sealed in the original moisture resistant light protected package and store in a cool dry place not above 30 C 86 F Do not refrigerate place in direct heat or sunlight or leave bottle open DO NOT use SureStep Test strips beyond the expiration date m f using test strips from a bottle write the discard date on the bottle label Discard unused test stri ps four months after first opening the bottl e m DO NOT use SureStep Test Strips that are bent torn cut or changed in any way
35. our 14 and 30 day averages as 27 8 mmol L The time and date must be reset every time the batteries are replaced 46 CARING FOR YOUR METER Your SureStep Blood Glucose Cleaning the Meter Meter is easy to maintain However to keep it in good operating condi tion follow these simple rules gt z m z z O m Clean the test strip holder cover and base lens area and contact points with water when there is General Care dirt blood or lint present Keep your meter dry and avoid CAUTION exposing it to extremes in temper m Use only water when cleaning ature Do not store your meter or the meter Do not get water test strips in a car or refrigerator inside the SureStep M eter Never immerse the meter or hold it under running water m Do not use cleansers or glass cleaners with ammonia m When disinfecting the meter Dropping the meter could damage its electronics If you drop your meter do a control solution test to ensure it is working properly Do not take the meter apart use a 1096 bleach solution Sensitive parts could be damaged 9 parts water 1 part bleach causing false results and voiding and remove with water the warranty 47 MAINTENANCE Always clean your meter when this symbol appears Er 5 n If you are concerned that your test results do not compare with how you feel clean the meter and do a control solution test to check if itis working properl
36. ry time you use a new package turn the meter on it will automati of test strips and changed if the cally recall and display your last code number is different most recent result with date CODE 7 Example Example LEARNING Apply Blood Sample to Pink Test Square Push the Test Strip Pink Side Up Firmly into the Test Strip Holder Until It Stops t If you fail to completely insert the test strip the test may start However you may receive an inaccurate low result Meter Is Reading Your Result The result appears on average in 30 seconds The clock may flash longer at cooler temperatures or shorter at warmer temperatures Test Result The meter displays results from O to 27 8 mmol L 0 500 mg dL with time and date 5 g 6 Example Y mmol g mmol L l L 0 00 em 17 HI mmol L Clean Meter and Test Strip Holder a In virtually all cases above gt 27 8 mmol L 500 mg dL the 5 E meter reads H E r H I H Replace the Two AAA Alkaline mmol L mmol L B atteri es weeny M1 ILI LJLI PM tt When proper procedures are followed a reading of Hi means very high blood glucose severe hyperg ycemia In extremely rare circumstances the meter will read Er instead of HL above 27 8 mmol L 500 mg dL Compare the colour of the test strip confi rmati on dot with the Colour Chart on the test strip package see pages 34 and 35 CODING CODING THE METER
37. t the see pages 51 53 batteries are low If the symbol is flashing the bat teries are dead 66 Error Messages The meter gives specific error mes sages when it detects a problem with its internal functions the test strip or the testing procedure However improper use may cause ERROR POSSIBLE CAUSE 1 Blood was applied to the wrong side of the test strip or an inaccurate result without producing an error message or a symbol When error messages appear note the error number turn off the meter then resolve the error by following these instructions WHAT TO DO 1 Clean the meter Repeat A the test with a new test 3 Sac strip applying blood to the pink test square 2 Not enough blood is on the test strip or 67 2 Repeat the test with a new test strip Apply a larger e drop of blood to the pink test square and verify that the confirmation dot on the back of the test strip has ton Dot turned completely blue m Qo gt O m o POSSIBLE CAUSE 3 The test strip was inserted more than two minutes after applying blood or WHAT TO DO 3 Repeat the test with anew test strip Insert it within two minutes after applying blood You may have a very high blood glucose level possi bl y exceeding 27 8 mmol L 500 mg dL Do a visual check of the colour of the confirmation dot versus the Colour Chart on th
38. the package of test strips you are using The meter will retain this code until you change it 11 Q fe z Z ol o zZ Xx Oo Lu I Oo CHECKING THE SYSTEM The SureStep System does not require a check strip The meter performs an automatic check every time you turn it on SureStep Glucose Control Solution Control solution is used instead of blood to tell you that the SureStep Blood Glucose M eter and SureStep Test Strips are working together properly The control solution PAS contains a known amount of A glucose that reacts with a SureStep Test Strip ES Ep Dae SureStep Glucose Control Solution Control Solution Test Do a control solution test Before testing with the SureStep Blood Glucose Meter for the first time Every time you open a new package of test stri ps Whenever you suspect that the meter or test strips are not working properly When your results do not reflect how you feel If you drop the meter IMPORTANT CONTROL SOLUTION TEST INFORMATION m Use only SureStep Glucose Control Solution m Check the expiration date Do not use if expired Record the discard date on the control solution vial Discard the vial three months after first opening it The control range printed on the test strip bottle is for SureStep Glucose Control Solution only It is NOT a recommended range for your blood glucose level Do not store the glucose control sol
39. uch blood Step 2 Check the to the test strip if the entire white Confirmation Dot m pad is soaked You must begin the After a few seconds look at the test with a new test strip to avoid confirmation dot on the back of M false results from too much blood the test strip If itis completely blue go on with the test Too Much Blood Enough Blood et Confirmation Dot Front Front Back 29 TESTING If any white patches or white streaks appear on the confirmation dot you have not applied enough blood for an accurate test You must start the test over with a new test strip Not Enough Blood R e Back Caution If you do not insert the test strip properly you may get an inaccurate result 30 Step 3 Insert the Test Strip and Read Result Turn the SureStep Test Strip to the front side and slide it into the test strip holder pink side up Push the test strip in firmly until it stops Insert the test strip within two minutes after applying blood to obtain an accurate result ri X The flashing clock symbol appears while the meter is reading your result You will hear a three tone beep when the meter displays your result Results appear on average in 30 seconds 5 g 5 9 Example mmol L mmol L in mm 471 ILI LILI PM dI The result is displayed first with the time and then with the date time
40. ution at room temperatures above 30 C 86 F Do not refrigerate or freeze m If a control solution test falls outside of the control range do not use the meter to test your blood until you get a control solution test result within the range Call the LifeScan Customer Care Line at 1 800 663 5521 U S A 1 800 227 8862 if you need assistance WARNINGS m Control solution is NOT TO BE USED as a cleaning solution DO NOT swallow or inject control solution or put itin your eyes m Control solution contains a dye that stains clothing 13 fe I m O 2 z o o O Lu I o Follow the test procedure using SureStep Glucose Control Solution instead of blood Before Testing Check the Code After turning the meter on the last result appears followed by the CODE symbol and number If the code on the meter does not match the code on the test strip package press the green C button until the codes match Green C Button LIFESCAN Example 14 Step 1 Apply a Small Drop of Control Solution After shaking the control solution vial apply one drop of control solution to the pink test square Note Applying too much control solution may cause out of range results and make the meter dirty Step 2 Check Confirmation Dot Step 3 Insert the Test Strip Check to see that the confirmation and Read Result dot on the back of the test strip Within two minutes a
41. y Q9 mmol L This symbol will also appear after turning on your meter when your previous test ended in an error and the meter did not display a result Recalling All Results in Meter Memory To access the meter memory press the blue power button and hold down for five seconds When the display flashes release the blue power button You are now in memory mode First the 14 day average will appear The average is calculated from the blood glucose results obtained during the last 14 days When you press the green C button your 30 day average appears Consult your healthcare professional for the appropriate use of these averages Each time you press and release the green C button the meter will recall up to your last 150 test results in order To scroll quickly through the results press and hold the green C button LIFESCAN Green C Button Blue Power Button 53 mmol L ud mmol L iH d9 30 d4 sg gy mmol m gH LLL Examples 45 m O X lt gt x O Lu If a previous test resulted in an Uploading Memory Data error condition the error will be stored in the memory with Test results stored in the memory may be uploaded to a personal Meas computer Call the LifeScan Q Customer Care Line at 1 800 663 5521 U S A 1 800 382 7226 E n 5 for more information FA Example Note A H1 result will be included in y
42. y Clean the meter using these easy steps 48 Step 1 Remove the Test Strip Holder Press down at the top end near the blue power button of the test strip holder and slide it away from the meter Step 2 Clean the Test Strip Holder Remove debris from the test strip holder by wiping gently with a cotton swab or cloth dampened with water Make sure you thoroughly wipe the grey area on the inside cover Wash both sides of test strip holder base carefully clean around the hole Dry the test strip holder completely with a soft cloth or lint free tissue Step 3 Clean the Lens Area and Contact Points Use a cotton swab or a soft cloth dampened with water to wipe the lens area and contact points Be careful not to scratch the lens area z Z m gt z 9 m Top of Base L Bottom of Base Inside Cover Grey Area Hole clean both sides Base Dry with a soft cloth or tissue that does not contain lint lotion or perfume Do not use abrasive materials such as paper towels LIFESCAN Contact Points Lens Area SureStep 49 MAINTENANCE Step 4 Replace the Test Strip Holder 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 firmly in place Make sure it does not extend beyond the met
43. y 60 36 What This Means for You Frequent blood glucose testing is the best means you have for keeping track of how well you are doing with the factors that affect your diabetes medi cation diet exercise and stress management Blood glucose test results can also tell you whether your diabetes is changing in ways that might require an adjustment to your treatment plan Always consult your healthcare professional before making any adjustments Frequency of Testing How often you need to test your blood glucose will vary according to your age the type of diabetes you have the medications you are taking and your physical and emotional health Your health care professional will guide you After you decide when and how often you should test it is impor tant that you make testing part of your daily routine Comparing Meter and Laboratory Results The SureStep System s plasma calibration enables you to more directly compare SureStep Meter results with your lab results because most laboratories measure plasma glucose however your meter blood glucose test result may be different from your labora tory result by up to 20 due to normal sources of variation Make sure you are following Testing Tips to Ensure Accuracy on pages 40 and 41 To make an accurate comparison between meter and laboratory results the meter test must be done within 10 to 15 minutes of the laboratory test If samples are tak
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