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Lifescan SureStep blood glucose monitoring system User's Manual
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1. Step 3 Insert New Batteries Insert two new AAA alkaline batteries matching the end of each battery with the signs inside the meter 51 Step 4 Close the Battery Door Insert the two hinges into the slots and press down until the tab catches Z m Z gt Z 9 m SETTINGS CHANGING METER SETTINGS Set Up Mode The SURESTEP Meter has been pre set to meet the needs of most users There are three features you can change Be sure you want to change these settings before enter ing the set up mode to avoid having meter settings that do not meet your needs FEATURE PRE SET ALTERNATIVE Automatic display On Off of last result Unit of mg dL mmol L measurement Beep signals On Off during testing 52 Entering Set Up Mode the meter automatically turns off To re enter set up mode begin with Step 2 1 Make sure the meter is off 2 Press and hold down the green C button 3 Press and release the blue power button while holding the C button Display of Last Result The SURESTEP Meter is pre set to automatically display your last test result when you turn on the meter o 4 Release the C button m After you release both the power and E In the set up mode the current set C buttons this symbol will flash on z ting for each of the three changeable the display G features is automatically displayed in sequence Each setting flashes Q
2. The meter is not Allow the meter to warm or within the temperature cool slowly before performing E I U range of 50 95 F another test Do not apply heat 10 350 or cold to the meter or test strips 1 The meter test strip 1 Clean refer to pages 45 49 holder lens area F r 5 and contact points pal are dirty or 2 The test strip holder 2 Slide the test strip holder is not fully in place into the meter until it is or completely inserted 62 ERROR POSSIBLE CAUSE WHAT TO DO Er 3 The test strip was partially inserted before turning the meter on 3 Remove test strip and turn meter off Turn meter on then reinsert test strip when insert test strip symbol appears Erb A possible failure has occurred in the meter Turn meter on Before testing check that the code on your meter matches the code on your test strip package If Erb continues call LifeScan Customer Services at 1 800 227 8862 SPECIFICATIONS Performance Characteristics Calibration Plasma equivalent 9p 2 G ke lt Q D O Lu Q 2 See the SURESTEP Test Strip Hematocrit Range 25 60 package insert for accuracy and precision information Dimensions Length 3 5 inches Width 2 4 inches Height 0 80 Power Supply Two AAA alkaline inches Weight 3 8 ounces with batteries batteries Battery Life Approximately 18 Operating Temperatures 50 95 F months when doing two tests
3. m U Z O oughly Warm water stimulates blood flow to the fingers Hang your arm down for 10 15 seconds before you stick your finger If you use alcohol to clean your finger N make sure you let it dry N Y 21 Hold the PENLET II Sampler firm By holding your hand down and 3 ly against the side of the finger Kneading your palm blood will 7E with the cap resting on the finger flow more quickly and easily to The harder you press the deeper your finger If necessary squeeze the puncture Press the dark gray the finger gently release button Proceed with the blood glucose test For information see pages 24 33 22 Step 4 Remove the Lancet When removing the PENLET II Cap be careful not to prick your self or anyone else After removing the cap grasp the two dark gray prongs located near the release button pointing the lancet down and away from you Pull back on the dark gray sliding barrel until the lancet drops out Another way to remove the lancet is to put the 23 protective disk back on the lancet Place the disk on a hard surface and gently stick the lancet needle into the protective disk Now carefully pull the lancet out Discard the used lancet in a con tainer for sharp objects m U Z O TESTING Step by Step Test Procedure When learning to use
4. SUresStep om Complete Blood Glucose Monitoring System Booklet LIFESCAN afohmonsfohmon company 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 You 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 important role in controlling your diabetes A recent study showed that keeping blood glucose levels close to normal can reduce the risk of complications by up to 60 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 A free instructional videotape is also available by calling LifeScan Customer Services If you have any ques tions please feel free to call the toll free numbers to speak with our Customer Services Department Remember to complete and mail the Warranty Registration Card A complimen tary gift is sent when we receive your Warranty Registration Card Important phone numbers
5. If you get results below 60 mg dL or above 240 mg dL and you do not have symptoms that match your results repeat the test following the guidelines on pages 38 39 to ensure testing accuracy You may also use the Color Chart see pages 32 33 If you have symptoms that match your results or if you continue to get results that fall below 60 mg dL or above 240 mg dL follow the treatment advice of your healthcare professional Record your test result in your LifeScan logbook The logbook allows you to keep a record of your test results along with information on your meals and medication i Kahn R and Weir G Joslin s Diabetes Mellitus 13th ed Philadelphia Lea and Febiger 1994 489 ii Krall L P and Beaser R S Joslin Diabetes Manual 31 Philadelphia Lea and Febiger 1989 261 263 m U Z O TESTING Press the blue power button to turn off the SURESTEP Blood Glucose Meter To save energy the meter automatically turns off three minutes after the meter displays your test result LIFESCAN SureStep 32 Optional Color Chart A Color 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 Color 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 s
6. Meter Serial Number LifeScan Customer Services 24 hours a day 7 days a week USA English 1 800 227 8862 Healthcare professional Espa ol 1 800 381 7226 Pharmacist Diabetes educator 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 recommendations apply to all blood glucose monitoring systems and are supported by the American Association of Diabetes Educators the American Diabetes Association the U S Food and Drug Adminis tration and the Health Industry Manufacturers 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 PENLET II Cap 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 Ifusing a 10 bleach solution to disinfect the meter be sure to completely remove any bleach from the meter and test strip holder with a cloth damp ened with water Bleach will react with the test strips and cause inaccurate results TABLE OF CONTENTS LEARNING THE SYSTEM 1 SURES
7. as a cleaning solution DO NOT swallow or inject control solution or put it in your eyes Control solution contains a dye that stains clothing 13 O x m 2 4 Z G G Y 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 v C Button 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 dirty the meter 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 after 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 K LIFESCAN O x m Q a Z O 15 The control solution result appears Compare the control solution test on average in 30 seconds result with the
8. flu etc Have I been under stress lately 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 40 very low hematocrits below 25 can cause false results 2 Severe dehydration and excessive water loss may cause false low results Severe dehy dration which may lead to many serious medical complications can be caused by Vomiting and diarrhea Prescription drugs e g diuretics 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 healthcare professional Follow the exercise and meal plans recommended by your healthcare professional Take insulin or diabetes medication at your scheduled times Keep in touch with your emotional and physical condition Stress or illness can affect diabetes Watch for symptoms of hypo glycemia low blood glucose and hyperglycemia high blood glucose Review your logbook of test results with your healthcare professional regularly References 41 i American Diabetes Association position state ment on the Diabetes Control and C
9. on the display for five seconds m While it flashes the setting may be LU n changed by pressing the C button After the last feature is displayed 53 SETTINGS If you wish to turn off the auto matic display of your last result press the C button This symbol will flash Q DEF indicating that the automatic display is turned off Then wait for the next feature setting unit of measurement to appear Unit of Measurement The meter is pre set to display test results in milligrams per deciliter mg dL You have the option to select millimoles per liter mmol L the unit of measurement used in Canada and some European countries The mmol L results include a decimal point but mg dL results do not In set up mode the unit of measure ment will be the second feature to flash on the display mg dL 54 If you wish to change the unit of measurement to mmol L press the C button This symbol will flash on the display nmol Then wait for the next feature set ting beep signals to appear Beep Signals The SURESTEP Blood Glucose Meter uses beeping tones to signal various steps in the meter 55 procedures However these tones do not indicate that the procedures are being performed correctly The meter is pre set to emit three differ ent beep signals 1 A single short beep signals each step in the test procedure 2 A single long beep accompanies error messages a Hi result and c
10. sterile lancet every time you test Donot use lancet if protective disk has been removed or damaged Never use a lancet that has been used by someone else If you share a PENLET II each person should always use a new lancet and a new or prop erly disinfected cap a For assistance call LifeScan Customer Services 1800 227 8862 18 Step 1 Insert a Lancet in the PENLET IT Automatic Blood Sampler Remove the PENLET II Cap by pulling it straight off Insert a new sterile lancet into the Hold the lancet firmly and gently lancet holder twist and pull off the protective disk m U Z O Note Save the protective disk for safe removal of the lancet after testing 19 TESTING Choose either the regular or deep Step 2 Cock the PENLET II penetration PENLET II Cap and Sampler slide it back onto the PENLET II Holding the lower portion of the Sampler PENLET II Sampler pull out the dark gray sliding barrel until it clicks If it does not click the PENLET II Sampler may have been cocked when the Regular i lancet was inserted Deep Penetration 20 Step 3 Get a Drop of Blood To avoid soreness choose a site on Wash your hands with soap and the side of your fingertips To avoid warm water and dry them thor calluses choose a different spot each time you test
11. the eyes kidneys and ner vous system by approximately 60 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 medication 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 health care 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 healthcare professional will guide you After you decide when and how often you should test it is important 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 laboratory result by up to 20 due to normal sources of variation Make sure you are follow ing Testing Tips to Ensure Accuracy on pages 38 39 To make an accurate comparison between meter and laboratory results the meter test must be done within 10 to 15 min utes of th
12. CAN B company IES Lancets Inside Tray LIFESCAN Extra Space for Diabetes Supplies and Syringes SURESTEP Blood Glucose Meter Front LIFESCAN DISPLAY 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 C BUTTON Green Codes the meter changes the meter settings and scrolls through the memory POWER BUTTON Blue Turns the meter on and off CONTACT POINTS Sense the position and orientation of the SURESTEP Test Strip X s E U L 5037 ZG 00171 U SureStep BLOOD GLUCOSE METER Toll free customer service UNITED STATES G English 1 800 227 8862 Espa ol 1 800 381 7226 ANADA 1800 663 5521 _ LIFESCAN kerhenn Milpitas CA 95035 022 2 No 125 Risk Class 2 LIFESCAN INC 1 AW 052 178 01A Made i 1998 nus e X TEST STRIP HOLDER Closed Test Strip Insertion Point The cover protects the lens area and the base holds the SURESTEP Test Strip m gt Es zZ zZ e LEARNING SURESTEP Test Strips When blood is applied to the pink test square it is absorbed and a chemical reaction t
13. Strips that are bent torn cut or changed in any way Before testing the confirmation dot should be off white DO NOT use test strip if confirmation dot is darker than the color of an unused test strip shown on the Color Chart included with the test strip package 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 strips For reliable results use only SURESTEP Test Strips made by LifeScan 5 a m gt D Z O LEARNING Display Symbols The SURESTEP Blood Glucose Meter uses symbols to guide you through a test 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 power button All of these symbols should appear Call LifeScan Customer Services at 1 800 227 8862 if any segments are missing Meter Memory Result Your SURESTEP Meter stores up to 10 blood glucose or control solution test results in its memory Every time you turn the meter on it will automatically recall and display your last most recent result Q IUH Example Code Number The number on the display must match the code num ber on your SURESTEP Test Strip package It must b
14. TEP Blood Glucose Meter 3 SURESTEP Test Strips y 4 Display Symbols 6 CODING THE METER cone Three Easy Steps to Coding 10 CHECKING THE SYSTEM SURESTEP Glucose Control Solution 12 Control Solution Test 12 Control Solution Range 17 TESTING YOUR BLOOD CS Getting a Drop of Blood 18 Step by Step Test Procedure 24 Optional Color Chart 32 LifeScan Customer Services 24 hours a day 7 days a week USA English 1 800 227 8862 Espafiol 1 800 381 7226 UNDERSTANDING YOUR RESULTS Overview 34 Comparing Meter and Laboratory Results 35 Expected Test Results Target Range 36 Testing Tips to Ensure Accuracy 38 Health Conditions Causing Out of Range Results 39 Recommendations for Better Diabetes Control 41 RECALLING RESULTS FROM METER MEMORY M Using the Meter for the First Time 42 Recalling All Results in Meter Memory 43 Recalling Your Last Result 44 CARING FOR YOUR METER DS General Care 45 Cleaning the Meter 45 Changing the Batteries 49 LifeScan Customer Services 24 hours a day 7 days a week USA English 1 800 227 8862 Espa ol 1 800 381 7226 CHANGING METER SETTINGS 52 Set Up Mode Entering Set Up Mode 53 Display of Last Result 53 Unit of Measurement mg dL or mmol L 54 Beep Signals 55 SOLVING PROBLEMS Helpful Messages 57 Error Messages Er Erb 59 SPECIFICATIONS Performance Characteristics 64 Guarantee and Warranty 65 QUICK REFERENCE GUIDE 67 LifeSca
15. a day 10 35 C Result Range 0300 mg dL Operating Humidity Range 0 27 8 mmol L Higher results 10 90 relative humidity are displayed as Hi noncondensing Display Liquid crystal Memory 10 test results Blood Source Whole blood 64 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 calling a LifeScan Customer Services Representative at the toll free number within 30 days of purchase After calling LifeScan you will need to return the SURESTEP Meter and a copy of your receipt to receive a refund Three Year Warranty If at any time during the first three 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 three year warranty from the origi nal date of purchase Write your date of purchase here 65 gt J a gt pa lt WARRANTY The Warranty Policy does not This warranty is in lieu of all other apply to the performance of the warranties express or implied SURESTEP Meter when used including any implied warranty of with any t
16. after cleaning Changing the Batteries the meter check to see if you insert The SURESTEP Blood Glucose ed the test strip holder completely Meter comes with two AAA alka and securely The test strip holder may be out of position See pages 59 63 for error descriptions ES Note If using a 10 bleach solution line batteries already installed When this symbol appears Z m Z gt Z C m this message may indicate that you the batteries are low and you have not completely removed the should replace them as soon as bleach residue on the gray area of possible The meter will still the inside of the test strip holder cover Wipe with a cloth dampened with water provide accurate test results with 49 MAINTENANCE low batteries If the symbol is flash ing the batteries are dead and you should replace them immediately You will not be able to do a test when the symbol is flashing Replace both batteries 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 50 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 Use your fingers or gently tap the meter on the palm of your hand Never tap the meter against a hard surface
17. akes place A blue color forms in the confirmation White Tip is inserted into the meter The side where you apply blood must be face up when you insert the test strip FRONT White Tip Pink Test Pink Test Square is Square 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 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 color the higher the blood glucose level Black Tip helps the meter detect that the strip has been BACK Black Tip inserted properly Confirmation Dot on the Confirmation ack of the test strip Dot is where you check to confirm proper blood application 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 86 F 30 C Do not refrigerate place in direct heat or sunlight or leave bottle open a DO NOT use SURESTEP Test Strips beyond the expiration date If using test strips from a bottle write the discard date on the bottle label Discard unused test strips 4 months after first opening the bottle DO NOT use SURESTEP Test
18. control range printed on the SURESTEP Test LIFESCAN Strip package o I m g TU mg dl L SURESTEP ilaga a Control SureStep ian wea Range 06 97 Example Note Do not use the Color Chart Exemplo to verify control solution tests o S O U lt O 16 When the control solution test result is within the control range you are ready to test your blood Your con trol solution test will be stored in the meter memory Record control solution tests in your logbook by placing a C next to the result to indicate a control solution test 17 Control Solution Range If test results fall outside the expected range repeat the test Results that fall outside the expected range may indicate the system is not working properly Some possible causes are If you are unable to resolve the problem call LifeScan Customer Services 1 800 227 8862 Procedural error Expired or contaminated control solution 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 59 95 F 15 35 C O T m Q a Z e G Z La U TESTING YOUR BLOOD 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 Use a new
19. e checked every time you use a new package of test strips and changed if the code num ber is different 2 m gt D Z a CODE d Example LEARNING Apply Blood Sample to Pink Test Square S 4 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 between 0 500 mg dL 0 27 8 mmol L Ina iw mg dL Example HI mg dL In virtually all cases above 500 mg dL 27 8 mmol L the meter reads HI mg dl Example When proper procedures are fol lowed a reading of H means very high blood glucose severe hyperglycemia In extremely rare circumstances the meter will read Er 1 instead of H i above 500 mg dL 27 8 mmol L Compare the color of the test strip confirmation dot with the Color Chart on the test strip package see pages 32 33 Clean Meter and Test Strip Holder ES Replace the Two AAA Alkaline Batteries m gt Es Z Z O CODING CODING THE METER Code numbers are used to calibrate the SURESTEP Test Strip with the SURESTEP Meter for accurate results You must code the met
20. e laboratory test If samples are taken more than 15 minutes apart the two tests could have very different results Blood glucose levels can change significantly over short periods especially if you have recently eaten ES m GH S r sd i RESULTS exercised taken medication or experienced stress In addition if you have eaten recently the blood glucose level from a fingerstick can be up to 70 mg dL higher than 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 com parison tests Factors such as a high or low hematocrit amount of red blood cells in the blood or severe dehydration loss of body fluid may also cause a meter result to be different from a laboratory result For more detail see pages 39 40 36 Expected Test Results Target Range Your test results will vary somewhat from test to test Blood glucose 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 recommended by your health care professional Once you have established your target range you will be able to detect when your results are high or low and can take action with advice from your health care professio
21. er 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 The result from your last blood glucose or control solution test will appear ny IU Example mg dl 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 number on the test strip package v C Button LIFESCAN Q e zZ O Example The code is now set for the package of test strips you are using The meter will retain this code until you change it 11 G Y O Lu I O CHECKING THE SYSTEM The SURESTEP System does not Control Solution Test require a check strip The meter performs an automatic check every ti
22. ert the test strip within two minutes after applying blood to obtain an accurate result UFESCAN m U Z O TESTING 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 Example wy IU mg dL The meter displays results between 0 and 500 mg dL In virtually all cases above 500 mg dL the meter reads HI Note Your meter is designed to give accurate results at temperatures between 50 and 95 F 10 35 C 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 calibrat ed to give plasma values Because most clinical laboratories measure plasma glucose the SURESTEP System enables you to more directly compare meter results with lab results See pages 35 36 to learn how to compare meter and lab results IMPORTANT When proper procedures are followed the meter will display H 1 when your result is above 500 mg dL 27 8 mmol L This indicates very high blood glucose severe hyperglycemia Low and High Blood Glucose Test results below 60 mg dL 3 3 mmol L mean low blood glucose hypoglycemia Test results greater than 240 mg dL 13 3 mmol L mean high blood glucose hyperglycemia
23. ertain mistakes in doing the test procedure 3 A three tone beep sounds when the meter displays a test result and when the meter is in set up mode on the beep signal feature GH m r4 Q 0 SETTINGS If you want the meter to operate without beeps enter the set up mode After the meter displays the memory and unit of measurement features the meter will sound a three tone beep and flash this message Un 56 Press the C button to turn off the beep signals The following display will appear DEF You will hear a three tone beep when UFF is first displayed Then it will flash silently until the meter turns off The meter will continue to use these settings until you change them SOLVING PROBLEMS When any of the following symbols problems but do not appear in all or error messages appear there cases when a problem has occurred may be a problem with the meter In most cases a problem is easy to test strip or the way in which you solve Assistance is available from are doing the procedure These LifeScan Customer Services 24 messages help to identify certain hours a day at 1 800 227 8862 Helpful Messages SYMBOL MESSAGE WHAT TO DO The test strip was not Push the test strip in firmly fully inserted until it stops T E m 77 L gt a m H 57 MESSAGE WHAT TO DO 1 The test strip was inserted before the meter was turned on or before the insert test strip symb
24. est strip other than merchantability or fitness for a SURESTEP Test Strips from particular purpose 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 the toll free number for instructions 66 CODING THE METER Before testing make sure the meter is coded correctly 3 STEP TEST PROCEDURE LIFESCAN Example Meter automatically displays last test result LIFESCAN CODE g Example Example Code number is 4 Press C button until automatically code number on meter displayed matches code number on test strip package Press 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 read result 30 second average test time 3 67 O C7 A I m T m D m Z C7 m UU Z U LC U LL Li LC x O 5 O BLOOD APPLICATION How you can be sure that you have applied the right amount of blood Front Back Ol A fe Pink Test Square White Confirmation Pad Dot Pink test square is where you apply a drop of blood White pad absorbs the excess blood that may extend bey
25. hade for new unused test strips Use the Color Chart in the following two ways Before testing Compare the level is between the values printed confirmation dot on the back of next to the two colors This compar m the new test strip to the shade ison will give you a rough estimate gt marked unused on the chart of your blood glucose level G Do not use the test strip if the confirmation dot is darker than S i the color of an unused test strip m on the Color Chart A After testing Directly after read ing a meter result you can com pare the color of the test strip con firmation dot with the colors on the chart The color of the confir mation dot will either match one of the colors on the chart or fall between two colors When the color of the blue dot falls between two colors your blood glucose Note If your Color Chart reading and meter result do not agree and do not reflect how you feel follow the testing tips for accuracy on pages 38 39 Do not use the Color Chart with control solution tests 33 RESULTS UNDERSTANDING YOUR RESULTS Overview Recent Diabetes Findings In 1993 the National Institutes of Health concluded an extensive long term 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 without diabetes you can reduce the risk of complications involving
26. ically turns off 26 You can apply blood to the pink test square in one of two ways d m 1 Hold the test strip under your OR 2 finger and touch the drop of blood 2 Turn the test strip over and dab 5 to the pink test square the pink test square to the finger You can touch the test strip The pink test square will quickly absorb ay the blood and the confirmation dot will begin changing color 27 TESTING You have applied too much blood to the test strip if the entire white pad is soaked You must begin the test with a new test strip to avoid false results from too much blood Too Much Blood 8 O ra Front e Step 2 Check the Confirmation Dot After a few seconds look at the confirmation dot on the back of the test strip If it is completely blue go on with the test Enough Blood Confirmation Dot Front Back 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 P Not Enough Blood g y AUROR I Caution If you do not insert the test strip properly you may get an inaccurate result 29 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 Ins
27. ilpitas California 95035 05225103A AW 052 251 03A Patents Pending O LIFESCAN INC 1998
28. ip 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 gray 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 Top of Bottom Cover of Base L Inside Cover Base Gray Area Hole clean both sides 47 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 Dry with a soft cloth or tissue that does not contain lint lotion or per fume Do not use abrasive materials such as paper towels pam Contact Points Lens Area SureStep Z m Z gt Z 9 m MAINTENANCE Step 4 Replace the Test Strip Holder Slide the test strip holder into the meter press down and push forward at the 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 meter Note You can clean the outside of the meter by lightly wiping it with a damp cloth Turn on the meter LIFESCAN If this symbol appears
29. me you turn it on Do a control solution test Before testing with the SURESTEP Blood Glucose Meter for the SURESTEP Glucose Control Solution first time Control solution is used instead of blood Every time you open a new pack to tell you that the SURESTEP Blood age of test strips Glucose Meter and SURESTEP Test Whenever you suspect that the Strips are working together properly meter or test strips are not working The control solution contains properly do amoan of glucose When your results do not reflect that reacts with a SURESTEP h E ow you feel Test Strip If you drop the meter SURESTEP Glucose Control Solution IMPORTANT CONTROL SOLUTION TEST INFORMATION Use only SURESTEP Glucose Control Solution Check the expiration date Write the discard date on the vial Do not use if expired Discard the vial 3 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 solution at room temperatures above 86 F 30 C Do not refrigerate or freeze 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 LifeScan Customer Services at 1 800 227 8862 if you need assistance Warnings Control solution is NOT TO BE USED
30. n Customer Services 24 hours a day 7 days a week USA English 1 800 227 8862 Espa ol 1 800 381 7226 LEARNING THE SYSTEM The SURESTEP 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 under stand symbols guide you through the test procedure and help you if any problems arise SURESTEP Test Strips are the only test strips that have been specifical ly designed developed and tested for use with the SURESTEP Meter to ensure consistent quality and accuracy For reliable results and to maintain the manufacturer s complete service support and warranty use only SURESTEP Test Strips made by LifeScan m gt D Z Z e LEARNING SureStep Complete Blood Glucose Monitoring System QUICK REFERENCE BEFORE TESTING See inside for instructions on proper blood application and coding the meter IMPORTANT Read detailed instructions in your SureStep Owner s Booklet before doing a test LIFES
31. nal GLUCOSE RANGES FOR PEOPLE WITHOUT YOUR TARGET DIABETES mg dL RANGES mg dL Before breakfast 70 105 Before lunch or dinner 70 110 1 hour after meals Less than 160 2 hours after meals Less than 120 Between 2 and 4 a m Greater than 70 37 ES m GH E 12 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 medication or stress repeat the test If the result is similar and still outside of your range try these troubleshooting steps Before Testing Wash your hands Use a new sterile lancet Check the expiration date on the test strip package If it has passed discard the unused test strips and open a new package When using test strips from a bottle discard any remaining test strips 4 months after first opening 38 Make sure the confirmation dot on the unused test strip is not darker than the color of an unused test strip shown on the Color Chart Make sure the code on the meter matches the code on the test strip package a Do a test with SURESTEP Glucose Control Solution to verify that the test strip and meter are working properly Make sure the meter test strip holder lens area and contact points are clean Follow instructions on pages 45 49 After Testing Make sure you applied enough blood to the te
32. nserted more than strip Insert it within 2 minutes 2 minutes after after applying blood applying blood or 4 You may have a 4 Do a visual check of the color of very high blood the confirmation dot versus the glucose level Color Chart on the test strip pack possibly exceeding age A color that matches or is 500 mg dL darker than the 350 mg dL color on the chart indicates a high blood glucose level Follow the treatment advice of your health care professional 1 Not enough blood 1 Repeat the test with a aina T was applied to the new test strip Apply a test strip or larger drop of blood to the e pink test square and verify that the confirmation dot on the back of the test strip has turned completely blue 60 ERROR POSSIBLE CAUSE WHAT TO DO 2 The test strip has been altered exposed to air or has passed its expiration date 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 ErJ 1 The test strip was removed or partially removed before the result was displayed or 1 Do not remove the test strip until the meter displays the result 2 The meter contact points are dirty Note If more than two minutes have passed since you applied blood to the test strip repeat the test with a new test strip 2 Clean meter contact points ERROR POSSIBLE CAUSE WHAT TO DO
33. ol appeared or 1 Remove the test strip and reinsert the T strip after this symbol appears t 2 The test strip was inserted incorrectly or 2 Reinsert the test strip tip first with the pink side facing up 3 The test strip was inserted too quickly 3 Reinsert test strip slowly If the symbol is constant the batteries are low If the symbol is flashing the batteries are dead 58 Replace the batteries see pages 49 51 Error Messages The meter gives specific error mes result without producing an error sages when it detects a problem with message or a symbol When error mes its internal functions the test strip sages appear note the error number or the testing procedure However turn off the meter then resolve the improper use may cause an inaccurate error by following these instructions ERROR POSSIBLE CAUSE WHAT TO DO 1 Blood was applied to 1 Clean the meter Repeat the test f Test the wrong side of the with a new test strip applying test strip or blood to the pink test square 2 Not enough blood is 2 Repeat the test with a new test on the test strip or strip Apply a larger drop of blood to the pink test square and Confirmation verify that the confirmation dot on the back of the test strip J has turned completely blue 59 POSSIBLE CAUSE WHAT TO DO 3 The test strip was 3 Repeat the test with a new test i
34. omplications Trial 1993 Clarke W L et al Diabetes Care Vol 10 No 5 1987 622 628 Surwit R S and Feinglos M N Diabetes Forecast 1988 April 49 51 Sacks D B Carbohydrates Burtis C A and Ashwood E R ed Tietz Textbook of Clinical Chemistry Philadelphia W B Saunders Company 1994 959 Krall L P and Beaser R S Joslin Diabetes Manual Philadelphia Lea and Febiger 1989 138 LifeScan data on file Wickham N W R et al Practical Diabetes Vol 3 No 2 1986 100 Cohen F E et al Diabetes Care Vol 9 No 3 1986 320 322 Atkin S H et al Fingerstick glucose determi nation in shock Annals of Internal Medicine Vol 114 1991 1020 1024 20 m 2 Le E L gt oc fe Lu RECALLING RESULTS FROM METER MEMORY The SURESTEP Blood Glucose Meter is pre set to automatically display your last test result when the meter is turned on You can also review your last result immediately after a new test is completed The meter stores your 10 most recent blood glucose or control solution test results in its memory When the memory is full the oldest result is dropped as the newest is added 42 Using the Meter for the First Time The first time you turn on your meter the following symbol will appear briefly showing that there is no test result in the memory Q mg dL This symbol will al
35. ond the pink test square Do not apply blood directly onto the white pad Confirmation dot on back of test strip is where you check to confirm proper blood application Enough Blood ia Front Back Not Enough Blood Back Too Much Blood L L L Front 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 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 strip to avoid false low results 68 If there is no white visible on the white pad you have applied too much blood You must start the test over with a new 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 medications El Folleto para el Propietario del SURESTEP se encuentra disponible en espa ol Para recibir su copia gratuita favor del llamar al n mero gratis 1 800 381 7226 The SURESTEP instructional materials are available in Spanish To receive your free copy please call toll free 1 800 381 7226 LifeScan Customer Services toll free numbers 24 hours a day 7 days a week U S A English 1 800 227 8862 Espa ol 1 800 381 7226 LIFESCAN affohnronfohnsen company M
36. ood Glucose Meter is easy to maintain However to keep it in good operating condi tion follow these simple rules General Care Keep your meter dry and avoid exposing it to extremes in temper ature Do not store your meter or test strips in a car or refrigerator 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 Sensitive parts could be damaged causing false results and voiding the warranty 45 Cleaning the Meter Clean the test strip holder cover and base lens area and contact points with water when there is dirt blood or lint present CAUTION Use only water when cleaning the meter Do not get water inside the SURESTEP Meter Never immerse the meter or hold it under running water Do not use cleansers or glass cleaners with ammonia When disinfecting the meter use a 10 bleach solution 9 parts water 1 part bleach and remove with water 2 E m Z gt Z O m MAINTENANCE Always clean your meter when this symbol appears ES 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 it is working properly Clean the meter using these easy steps 46 Step 1 Remove the Test Strip Holder Press down at the top end near the power button of the test str
37. so 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 Press the green C button to scroll Meter Memory through the memory Each time you To access the meter memory press press the green C button a number the blue power button and hold from most recent 1 to oldest 10 down for five seconds When the will appear telling you the order of display flashes release the blue the test result followed by the result power button You are now in memory mode Your most recent result will appear on the display ji O Q Q 109 mg dL il Order of test result Result d i IS most recent test first Example mg dl Green C Button LIFESCAN m Eq GQ J lt Order of test result Result second most recent Example 43 If a previous test resulted in an error condition the error will be stored in the memory Q Q Order of test result Result third most recent Example gt oc fe Lu 44 Recalling Your Last Result Immediately after completing a test you can also review your previous test result Current result Example In IU E zm L With the current test result displayed press and hold the green C button Your previous result will appear Green C Button Previous result Example CARING FOR YOUR METER Your SURESTEP Bl
38. st strip by inspecting the test strip confirmation dot to be certain it turned completely 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 color of the test strip confirmation dot with the Color Chart on the test strip package see pages 32 33 IMPORTANT If you have followed the tips to ensure accuracy and your blood glucose results are still out of range call your health care 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 following questions How do I feel Do I 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 39 20 m 2 i L RESULTS Do I have symptoms of high blood glucose hyperglycemia fatigue dry mouth and skin increased thirst or hunger blurry vision increased uri nation rapid deep breathing or a fruity smell to the breath What have I eaten How much have l exercised Am I ill common cold
39. the meter for your own diabetes care first do a control solution test When the control solution test result is within the control range you are ready to practice by testing your blood Next you should perform three blood glu cose tests in a row You will know you have applied blood correctly when the confirmation dot turns completely blue and you obtain a glucose result from the meter 24 Choose a clean dry work surface Make sure you have your LIFESCAN Unused S sterile lancet SureStep SURESTEP Blood Glucose Meter SURESTEP PENLET II Test Strip Sampler Before Testing Next the code number appears It Press the blue power button must match the code number on the m SURESTEP Test Strip package If it gt urescan pr does not match change the meter G code number following the instruc tions on pages 10 11 CODE Your last test result will appear l o Q n U Example IL mg dL Example 25 TESTING Then these symbols will alternate Step 1 Apply Blood to the on the display Test Strip Apply a drop of blood to the center S of the pink test square Note Do not add more blood to the first drop Adding more blood may give false results Apply blood to Insert test strip test strip into meter The meter is ready for a test You have two minutes to insert the test strip before the meter automat
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