Lifescan SureStep Blood Glucose Monitor User's Manual
Contents
1. IMPORTANT Control Solution Test Information Read the SureStepPro Control Solutions package insert for detailed information e Gently shake each vial of control solution before use e Do not use a control solution after the expiration date printed on the vial label Operation 21 Operation e Discard any unused portion 3 months after opening Write the opened date on the vial when you first open it e The control ranges printed on the test strip bottle are for SureStepPro Glucose Control Solutions only e Store the control solution at room temperatures below 30 C 86 F Do not refrigerate or freeze e The control solutions contain dye that stains clothing e The control solutions are not intended for human consumption e Control solution results can be affected at altitudes of 3000 feet or greater Read the SureStepPro Glucose Control Solutions package insert for specific information and correction factors 22 Chapter 2 Performing a Quality Control Test Turn on the meter Check the display and make sure that all symbol segments appear see Display Symbols on page 4 Check the Code When you turn on the meter the last result appears if this option is selected followed by the code number If the code on the meter does not match the code on the test strip bottle press the green C button until the codes match f C Button Make sure code numbers match Operation 23 Operation2. Introduction HI Result The meter reads HI in virtually all cases when a result is greater than 500 mg dL 27 8 mmol L mg dl IMPORTANT When the result is greater than 500 mg dL and proper procedures are followed the meter will display HI in virtually all cases The confirmation dot will also be darker than the 350 mg dL sample color dot on the test strip bottle Color Chart This indicates hyperglycemia Follow your institution s policies for treatment 8 Chapter 1 Error Messages When the meter detects a problem it displays a specific error message Er1 through Er6 Refer to Chapter 5 for more information on error messages Er SS Example Remove the Test Strip This symbol indicates that the test strip may have been inserted incorrectly or too quickly See Chapter 5 for more information me Wo Introduction 9 Introduction Replace the Two AAA Alkaline Batteries When this symbol appears the batteries are low and should be replaced as soon as possible When the symbol is flashing the batteries are dead and should be replaced immediately SureStepPro Test Strips SureStepPro Test Strips should be used with the SureStep Hospital System When blood is applied to the pink test square a chemical reaction takes place A blue color forms in the confirmation dot on the back of the test strip If the confirmation dot is completely blue this indicates that an adequate volume of sample was a
3. A CAUTION For accurate results the code number on the meter must match the code number on the test strip bottle 3 Apply a drop of control solution to the test strip as follows A CAUTION Applying too much or too little control solution may cause out of range results e Gently shake the control solution vial e Touch a drop of control solution to the center of the pink test square If the white pad becomes completely saturated you have applied too much control solution Repeat the application with a new test strip ron aS 24 Chapter 2 e Wipe the control solution vial tip with a lint free cloth or tissue before replacing the cap Check the confirmation dot on the back of the test strip to verify it has turned completely blue indicating an adequate amount of control solution was applied If white patches or streaks are visible you have not applied enough control solution Repeat the application with a new test strip Firmly insert the test strip all the way into the test strip holder until it stops the confirmation dot should be facing down Operation 25 Operation IMPORTANT If you fail to completely insert the test strip the test may start however you may receive an out of range result trescan IMPORTANT You have up to 2 minutes to insert the test strip after applying control solution If you insert the test strip after 2 minutes you may get an out of range result or an e
4. apply blood to the test square using a narrow bore pipette Operation 33 Operation Pipette Touch the blood emerging from the tip of a narrow bore pipette to the center of the pink test square 5 Check the white pad on the front of the test strip and the confirmation dot on the back of the test strip If the white pad becomes completely saturated you have applied too much blood for an accurate result Repeat the application with a new test strip 34 Chapter 2 Right Wrong A FRONT The confirmation dot Right Wrong should be completely b ae blue If white patches or streaks el lo are visible you have not applied enough blood for an accurate result Repeat the BACK application with a new test strip A CAUTION Do not apply additional blood to the test strip or you may get an inaccurate result If white patches or streaks continue to appear after you have repeated the test and used a larger volume of blood call the LifeScan Healthcare Professional Line at 1 800 524 7226 6 Firmly insert the test strip all the way into the test strip holder until it stops the confirmation dot should be facing down Operation 35 Operation A CAUTION If you fail to completely insert the test strip the test may start however you may receive an inaccurate low result urescan SureStep A CAUTION You have up to 2 m
5. capable of transmitting infection Follow proper precautions in accordance with your institution s policies when disposing of all materials Centers for Disease Control Report Guideline for Infection Control in Health Care Personnel Am J Infect Control 1998 26 289 354 16 Chapter 1 CHAPTER 2 Operation Coding the Meter The SureStep Meter is calibrated at the factory Although an internal verification is performed each time the meter is turned on a system calibration meter and test strip is necessary This is achieved at the start of each test when you enter the code number for the current bottle of test strips Each time you test or when you open a new bottle of test strips check that the code number on the meter matches the code number on the test strip bottle If the meter code does not match the code on the test strip bottle change the meter code Operation 17 Operation A CAUTION Match the code number on the meter display to the code number on the test strip bottle If the code numbers do not match the test results may be inaccurate 1 Turn on the meter by pressing the blue power button Check the display and make sure that all symbol segments appear see Display Symbols on page 4 The result from the last blood glucose or control solution test may appear mg dL Example Next the code number appears coRE l Example 18 Chapter 2 2 Match the code numbers The code nu
6. or cloth moistened with a 10 bleach solution 52 Chapter 4 Be sure to thoroughly wipe the gray area on the inside cover Clean both sides of the base Follow with a cotton swab or cloth moistened with water to remove residual bleach Thoroughly dry the test strip holder with a soft cloth or lint free tissue A CAUTION Bleach residue left on the test strip holder may lead to an error message or an inaccurate high result Cleaning and Maintenance 53 Cleaning and Maintenance 2 Clean the lens area and contact points Using a cotton swab or a cloth moistened with a 10 bleach solution wipe the lens area and contact points LIFescan Contact points SureStep Wipe this area even if it doesn t appear to be dirty Use a swab or cloth moistened with water to remove any residual bleach Dry with a soft dry cloth or lint free tissue Be careful not to scratch the lens area or get water inside the meter 3 Replace the test strip holder Slide the closed test strip holder into the meter Push the holder until it clicks into place Make sure the test strip holder is 54 Chapter 4 firmly in place and does not extend beyond the meter LIFescan Surestep If the following symbol appears after cleaning check to see if the test strip holder Cleaning and Maintenance 355 Cleaning and Maintenance was inserted correctly The test strip holder may be blocking the me
7. patient and provide medical care while awaiting the lab result 62 Chapter 5 e Do not use the Color Chart as a replacement for a meter result If you need help resolving an error or you encounter any other problem with the system contact the LifeScan Healthcare Professional Line at 1 800 524 7226 USA or 1 888 353 0800 Canada Error Messages Symbol Possible Cause What To Do lt 7 The meter detected 1 Repeat test with new S a problem with the test strip and Er i color of the test e Apply blood to pink strip test square only 7 e Make sure confir mation dot turns completely blue e Insert test strip within 2 min of applying blood 2 Check that sample hematocrit is within range 25 60 continued LifeScan Healthcare Professional Line 1 800 524 7226 Troubleshooting 63 Troubleshooting Symbol Possible Cause What To Do gt The meter detected 3 If you continue to get S a problem with the any error message H color of the test obtain a laboratory ri strip result and e Compare color of test strip confirmation dot to continued Color Chart on test strip bottle to see if glucose level is very high or very ow e Take appropriate steps o monitor patient and provide medical care while awaiting aboratory result J p Clean meter and repeat est with new test strip 5 Contact LifeScan for help LifeScan Hea
8. 10 followed by the result a gi mg dl Order of test result Test result example 2nd most recent result 46 Chapter 3 If a previous test resulted in an error condition the error will be stored in memory Q Q J Er5 Order of test result Test result example 3rd most recent result Recalling Most Recent Result After Testing Immediately after completing a test the result you obtained from the previous test can be reviewed 90 mg dL Current result Settings and Memory 47 Settings and Memory With the current test result displayed press and hold the green C button The previous result will appear 48 Chapter 3 CHAPTER 4 Cleaning and Maintenance General Care To keep the meter in good operating condition you must keep it clean and handle it with care Follow these simple rules e Keep the test strip holder and lens area clean e Keep the meter dry and avoid exposing it to extremes in temperature and humidity e Do not take apart the meter e If you drop the meter inspect it for obvious damage Press and hold down the blue power button and make sure that all Cleaning and Maintenance 49 Cleaning and Maintenance symbol segments appear see Display Symbols on page 4 Perform a control solution test prior to running a patient blood test Cleaning Proper cleaning is important to keep the meter in good condition and is essential for accurate re
9. CHAPTER 3 Settings and Memory Meter Settings The SureStep Meter has three features which are pre set but may be modified in set up mode Feature Pre set Alternative Display of last result On Off Glucose units mg dL mmol L Beep signals On Off Settings and Memory 39 Settings and Memory Entering Set up Mode 1 Turn off the meter by pressing the blue power button 2 Press and hold down the green C button 3 Press and release the blue power button while continuing to hold the C button 4 Release the C button rT Green C button Blue power button In the set up mode the current setting for each of the three changeable features is automatically displayed in sequence Each setting flashes on the display for 5 seconds While it flashes the setting may be changed by pressing the green C button To move 40 Chapter 3 quickly through the features press the blue power button repeatedly or press and hold it to scroll through the settings The meter will continue to use these settings until they are manually changed Display of Last Result The meter is pre set to automatically display the last test result when you turn on the meter If you wish to turn this option off enter set up mode The first feature displayed is the setting for the display of the last result The default is set to On Press the green C button to turn this feature off Q Q Un DFF Display of last re
10. Surestep Hospital Blood Glucose Monitoring System Hospital Meter Operator s Guide LIFESCAN a folmenafohnren company The SureStep Meter is for in vitro diagnostic use for the quantitative measurement of glucose in whole blood samples It should not be used for the diagnosis of diabetes 2002 1997 LifeScan Inc All rights reserved The system described herein is covered by one or more of the following US patents D371 198 D367 109 5 418 142 5 515 170 5 526 120 5 563 031 5 605 837 5 780 304 5 789 255 5 922 530 5 968 836 and 6 335 203 Use of the system described herein is protected under US patent 4 935 346 Purchase of the system described herein does not act to grant a license under these patents Such a license is granted only when the device is used with SureStepPro or OneTouch SureStep Test Strips No test strip supplier other than LifeScan is authorized to grant such a license and LifeScan does not endorse or encourage the use of any strips manufactured by anyone other than LifeScan Table of Contents Preface 6 isa eee eke Sek a dirias ON v About this Guide o on aannaaien vi Here s What You ll Find in this Guide vi Conventions Used in this Guide vii Help erpai acd ten be hag cea nee oa tet viii Chapter 1 Introduction 1 Learning the SureStep Meter 2 Display Symbols 00 00 0040 4 SureStepPro Test Strips 0005 10 Preca
11. To Do P The meter detected 1 Clean meter especially a problem with the gray area inside test E 5 optical system strip holder but r NOTE Before cleaning X compare color of test strip confirmation dot to Color Chart on test strip bottle If glucose level is very high or very low take appropriate steps to monitor patient and provide medical care e Repeat test with new test strip Make sure test strip holder is fully inserted into meter e Wait for Insert test strip symbol to appear on display before inserting test strip 2 If you continue to get any error message obtain a laboratory result Take appropriate steps to monitor patient and provide medical care while awaiting laboratory result 3 Contact LifeScan for help LifeScan Healthcare Professional Line 1 800 524 7226 Troubleshooting 69 Troubleshooting Symbol Possible Cause What To Do The meter detected 1 Wipe contact points in a problem with the lens area with cloth E 6 electronics moistened with water to cr remove residual bleach Dry thoroughly but NOTE Before cleaning compare color of test strip confirmation dot to Color Chart on test strip bottle If glucose level is very high or very low take appropriate steps to monitor patient and provide medical care e Repeat test with new test strip e Make sure code number entered at meter matches code number on test strip b
12. ed under the conditions listed below See the SureStepPro Test Strip package insert for accuracy and precision data power supply two AAA alkaline batteries result range 0 500 mg dL 0 27 8 mmol L display liquid crystal memory 10 test results sample type whole blood calibration plasma equivalent 73 a hematocrit range dimensions weight operating temperature operating humidity altitude 74 25 60 length 3 5 in 8 9 cm width 2 4 in 6 1 cm height 0 8 in 2 0 cm 3 8 oz with batteries 18 30 C 64 86 F 30 70 relative humidity noncondensing up to 10 000 ft 3048 m For more information read the SureStepPro Test Strip package insert Index A applying blood 32 34 blood symbol 6 control solution 24 battery compartment 3 replacing 57 59 symbol 10 beep signals 42 44 blood application 32 34 test performing 31 37 Cc C button 2 40 cleaning contact points 54 lens area 54 test strip holder 51 53 code number 5 18 19 checking 23 31 32 setting 17 20 Color Chart 13 15 38 62 confirmation dot 12 25 34 contact points 2 cleaning 54 control solution 21 23 applying 24 at high altitudes 22 result 27 28 test performing 23 27 75 a _____ D display of last result 41 display symbols 4 10 E error messages 9 63 70 G glucose control solution See control solution glucose units 42 H high result 38 l
13. er 2 Performing a Patient Blood Test Turn on the meter by pressing the blue power button Check the display and make sure that all symbol segments appear see Display Symbols on page 4 Check the Code When you turn on the meter the last result appears if this option is selected followed by the code number If the code on the meter does not match the code on the test strip bottle press the C button until the codes match k Button Make sure code numbers match Operation 31 Operation A CAUTION For accurate results the code number on the meter must match the code number on the test strip bottle 3 Obtain a drop of blood Obtain capillary blood by puncturing the finger using a lancing device The puncture site should be cleaned and thoroughly dried before obtaining the sample Follow your institution s policy and procedure guidelines 4 Apply blood to the test strip as follows Finger Stick Carefully touch the center of the pink test square to the drop of blood on the patient s finger The test area will quickly absorb the blood 32 Chapter 2 Syringe Touch the tip of the syringe to the center of the pink test square As the blood emerges from the tip of the syringe it is absorbed by the test square A CAUTION Avoid applying too much blood when using a syringe or you may get an inaccurate high result Alternatively dispense the blood from the syringe into a test tube then
14. eter FRONT C Button green Codes the meter changes meter settings scrolls through memory LIFESCAN Power Button blue Turns meter on and off Contact Points Sense position and orientation of test strip SureStep P Display Lens Area Shows test results and Contains the optics symbols that guide that reads glucose you through testing level Test strip holder covers lens area 2 Chapter 1 CLOSED OPENED Test Strip Holder Protects the lens and holds the test strip The insertion point is where the test strip is inserted Base Insertion Point E NOTE The test strip holder is interchangeable the same holder can be used in any SureStep brand meter BACK Meter Serial Number SureStep Example _ Blood Glucose Meter re Toll free customer service 2 UNITED states 1 800 524 7226 D cavava 1 888 353 0800 Battery S UFESCAN Compartment viscas GR e Holds two AAA m sn alkaline batteries lt x Introduction 3 Introduction Display Symbols The SureStep Meter uses symbols to guide you through a test and inform you if it detects a problem with the test strip or meter A display of all symbols appears briefly each time you turn on the meter To check that all display symbols are working press and hold down the blue power button IMPORTANT Carefully check that all symbols and symbol segments s
15. he two hinges into the slots and press down until the tab catches 6 Turn on the meter to verify power Cleaning and Maintenance 59 60 Chapter 4 CHAPTER 5 Troubleshooting The SureStep Meter displays prompts and error messages to indicate the system has detected a problem with its internal function the test strip or the testing procedure These messages help in resolving some common problems that may occur during testing However the meter cannot detect all problems When the meter does detect a problem it may not produce an error message every time the problem occurs In some situations improper use may cause an inaccurate result without producing an error message Troubleshooting 61 Troubleshooting A CAUTION While resolving an error message using the Troubleshooting section keep in mind the following e If patient symptoms indicate the need for treatment provide appropriate medical care before you continue with troubleshooting e If you repeatedly get any error message or you are otherwise unable to obtain a meter result perform a laboratory test Take appropriate steps to monitor the patient and provide medical care while awaiting the lab result e After any test you can compare the test strip confirmation dot to the Color Chart on the test strip bottle If the comparison indicates that the glucose level is very high or very low perform a laboratory test Take appropriate steps to monitor the
16. hown below appear each time you turn on the meter If any segments are missing call the LifeScan Healthcare Professional Line at 1 800 524 7226 t gt mg dl E t amp Chapter 1 Meter Memory Result The meter stores up to 10 blood glucose and control solution test results in memory When you turn on the meter the last most recent result is automatically displayed if this option is selected 93 Example Code Number The number on the meter display must match the code number on the SureStepPro Test Strip bottle Check the code number before every test Change the code number if it does not match the number on the test strip bottle CODE Example Introduction 5 Introduction Apply Blood Sample to the Test Strip This symbol prompts you to apply sample to the center of the pink test square S Insert Test Strip All the Way Into the Meter This symbol prompts you to firmly insert the test strip all the way into the test strip holder Firmly push the test strip until it stops A CAUTION If you fail to completely insert the test strip the test may start however you may receive an inaccurate low result 6 Chapter 1 Meter is Reading the Result The test result appears in approximately 30 seconds The time may vary depending on temperature and glucose level Test Result The meter displays results between 0 500 mg dL 0 27 8 mmol L 90 mg dL Example Introduction 7
17. ide the expected range repeat the test The system may not be functioning properly Do not use the system to test patient blood glucose levels unless the control solution result falls within the expected range If you have problems using the meter to test the control solutions or if the meter malfunctions call the LifeScan Healthcare Professional Line at 1 800 524 7226 Linearity Test A Linearity Solution kit is available from LifeScan The kit contains five levels of glucose solution used to check the linearity of the system Refer to your institution s policy for establishing the linearity of a test method Operation 29 Operation Run a linearity solution test as you would a control solution test Follow the instructions under Performing a Quality Control Test on page 23 testing the linearity levels in replicates as specified by your institution s policy Compare the linearity results with the linearity target values printed on the SureStepPro Test Strip bottle or with your institution s established ranges Linearity solution results can be affected at altitudes of 2000 feet or greater Read the SureStepPro Linearity Test Kit package insert for more information Patient Blood Test LifeScan recommends that only certified operators perform blood glucose testing using the SureStep Hospital Meter Follow your institution s policies for in service training to become a certified operator 30 Chapt
18. infection control 16 L lens area 2 cleaning 54 linearity test 29 M memory 44 48 messages error 63 70 helpful 71 meter care 49 50 76 cleaning 50 56 description 2 3 memory 44 48 settings 39 44 symbols 4 10 patient blood test performing 31 37 result 37 38 power button 2 precautions 14 16 Q quality control test performing 23 27 result 27 28 R results 7 control solution 27 28 high 8 38 linearity 30 patient 37 38 recalling 45 48 S settings 39 44 set up mode 40 symbols meter 4 10 T test results 7 control solution 27 28 high 8 38 linearity 30 patient 37 38 test strip holder 3 cleaning 51 53 test strip symbol insert 6 remove 9 test strips 10 13 Color Chart 13 15 38 62 U units glucose 42 77 LifeScan Healthcare Professional Line United States 1 800 524 7226 Canada 1 888 353 0800 LifeScan Website www LifeScan com www SureStepHospital com LIFESCAN a Gohnrena fohvxen company Milpitas California 95035 Printed in USA AW 050 097 03A 2002 LifeScan Inc 11 02
19. inutes to insert the test strip after applying blood If you insert the test strip after 2 minutes you may get an inaccurate result or an error message Discard the test strip and repeat the test with a new test strip 36 Chapter 2 The test result appears in approximately 30 seconds IMPORTANT Do not remove the test strip until the countdown is complete LIFESCAN BU SureStep 7 Remove the strip and dispose of it according to your institution s policies and procedures 8 Record the result If you are finished testing you can turn off the meter To save power the meter automatically turns off 3 minutes after it displays the result Operation 37 Operation Patient Results The meter displays results between 0 and 500 mg dL 27 8 mmol L The meter displays HI for results greater than 500 mg dL If an error message appears refer to the troubleshooting section for information IMPORTANT When the result is greater than 500 mg dL and proper procedures are followed the meter will display HI in virtually all cases Additionally the confirmation dot will be darker than the 350 mg dL sample color dot on the test strip bottle Color Chart This indicates hyperglycemia Follow your institution s policies for treatment If you have problems using the meter to test patient samples or if the meter malfunctions call the LifeScan Healthcare Professional Line at 1 800 524 7226 38 Chapter 2
20. lthcare Professional Line 1 800 524 7226 64 Chapter 5 Symbol Possible Cause What To Do The meter detected 1 Repeat test with new a problem with the test strip and E r c test strip Check test strip expiration date Do not use expired test strips or test strips beyond discard date Apply sample to pink test square only e Make sure confir mation dot turns completely blue Wait approximately 1 min but not more than 2 min after applying sample before inserting test strip e Do not alter test strips continued LifeScan Healthcare Professional Line 1 800 524 7226 Troubleshooting 65 Troubleshooting Symbol Possible Cause What To Do The meter detected 2 If you continue to get a problem with the any error message c test strip obtain a laboratory r result and e Compare color of test strip confirmation dot to Color Chart on test strip bottle to see if glucose level is very high or very ow e Take appropriate steps o monitor patient and provide medical care while awaiting aboratory result continued Ww Clean meter and repeat est with new test strip 4 Contact LifeScan for help LifeScan Healthcare Professional Line 1 800 524 7226 66 Chapter 5 Symbol Possible Cause What To Do r The meter detected 1 Clean meter especially a problem with the contact points in lens J position of
21. mber on the test strip bottle will range from 1 to 21 If the number on the display matches the code number on the test strip bottle begin testing If the two code numbers do not match follow step 3 to code the meter Code numbers do not match 3 If the code numbers do not match code the meter After the code symbol appears press and release the green C button The code symbol will flash Press and hold the C button until Operation 19 Operation the code number on the display matches the code number on the test strip bottle Button Code numbers match The code is now set for the package of test strips you are using The meter will retain this code until you change it Quality Control Test Three levels of SureStepPro Glucose Control Solutions are available to check that the SureStep Meter and SureStepPro Test Strips are working together properly Perform a control solution test e As required by your institution s quality control policy or local regulatory requirements 20 Chapter 2 e When you open a new bottle of test strips e Ifa patient test has been repeated and the blood glucose results are still lower or higher than expected e After cleaning the meter e If there are other indications that the system is not working properly e If you drop the meter Glucose Control Solution Use SureStepPro Glucose Control Solutions with SureStep brand meters and SureStepPro Test Strips only
22. n it 42 Chapter 1 Replace the test strip bottle cap immediately after removing a test strip and close the cap tightly Do not use test strips that are bent torn cut or damaged in any way Use each test strip immediately after removing it from the bottle Do not transfer test strips to a new bottle or any other container Compare the color of the test strip confirmation dot to the Unused color dot shown on the Color Chart on the test strip bottle label If the color of the test strip confirmation dot is darker than that shown on the Color Chart do not use the test strip The result may be inaccurate You have up to 2 minutes to insert the test strip into the meter after applying blood or control solution If you insert the test strip after 2 minutes you may get an inaccurate result or an error message Introduction 13 Introduction Precautions e Unexpected results should be confirmed by a laboratory test e Various conditions may cause the meter to produce a very low test result 20 mg dL 1 0 mmol L or less e If the patient has symptoms of low blood glucose follow your institution s policy for treatment e If the patient does not have symptoms of low blood glucose check the confir mation dot on the back of the test strip If the confirmation dot has white patches or streaks repeat the test with a new test strip If the confirmation dot is completely blue compare it to the
23. n necessary to successfully perform the test A CAUTION Alerts you to situations that could result in instrument damage failure in a procedure or possible inaccurate results i Help Read through the section of the guide specific to the operation you are performing Refer to the table of contents or index to locate information See Chapter 5 for troubleshooting information Call LifeScan Customer Service toll free at 1 800 524 7226 USA or 1 888 353 0800 Canada CHAPTER 1 Introduction The SureStep Hospital Blood Glucose Meter is one component of LifeScan s professional blood glucose monitoring system When used with SureStepPro Test Strips the meter measures a patient s blood glucose level from a whole blood sample taken at the bedside Blood is applied directly to the test strip before the strip is inserted into the meter A confirmation dot on the test strip helps you check that an adequate volume of sample was applied Meter display symbols guide you through the test procedure For accurate results use only SureStepPro Test Strips with the SureStep Hospital Meter SureStepPro Low Normal and High Glucose Introduction 1 Introduction Control Solutions are available to check that the meter and test strips are working together properly Read the appropriate package insert for information regarding SureStepPro Test Strips and SureStepPro Glucose Control Solutions Learning the SureStep M
24. oring System offers diabetes caregivers and patients off meter blood dosing of the test strip The design can help reduce the risk of transmission of blood borne pathogens between patients while providing accurate and reliable blood glucose results at the point of care So About this Guide The SureStep Hospital Meter Operator s Guide provides detailed instructions on using and maintaining the SureStep Meter Although operating the meter is straightforward it is important that you read the information presented in this manual as well as the SureStepPro Test Strip package insert Here s What You ll Find in this Guide Chapter 1 Introduction provides you with an overview of the meter its display symbols as well as general information about SureStepPro Test Strips Chapter 2 Operation includes instructions for coding the meter and performing a quality control test and a patient test Chapter 3 Settings and Memory provides information on the various meter settings and how you can change them Also included in this chapter is information on meter memory Chapter 4 Care and Maintenance instructs you on how to clean the meter and change the batteries Chapter 5 Troubleshooting lists the error codes that may appear during operation and offers possible solutions to correct a problem Conventions Used in this Guide E NOTE Points out additional information that may be helpful IMPORTANT Contains informatio
25. ottle 2 f you continue to get any error message obtain a laboratory result Take appropriate steps to monitor patient and provide medical care while awaiting laboratory result 3 Contact LifeScan for help LifeScan Healthcare Professional Line 1 800 524 7226 7O Chapter 5 Helpful Messages Symbol Meaning What To Do Test strip was not Remove test strip fully inserted into When Insert test mi test strip holder strip symbol appears firmly insert est strip into test t strip holder until it stops gt Not enough Remove test strip sample on test Check confirmation strip or test strip dot If white patches was inserted too or streaks appear quickly not enough blood was applied for an accurate result Repeat test with new test strip When Insert test strip symbol appears firmly and more slowly insert test strip until it stops LifeScan Healthcare Professional Line 1 800 524 7226 Troubleshooting 71 Troubleshooting Symbol Meaning What To Do If symbol is Replace batteries see constant batteries page 57 are low If symbol is flashing batteries are dead _ Result is greater See HI Result on than 500 mg dL page 8 for more 4 information I mg d LifeScan Healthcare Professional Line 1 800 524 7226 72 Chapter 5 Specifications The performance of the system has been evaluat
26. ounds when OFF is first displayed Then it will flash silently until the meter turns off Exiting Set up Mode You may exit set up mode at any time by pressing the blue power button and holding it down to turn off the meter Meter Memory The SureStep Meter is pre set to automatically display the last test result when the meter is turned on The meter stores the 10 most recent blood glucose and control solution test results in its memory When the memory is full the oldest test result is dropped as the newest is added Using the Meter for the First Time Each time you turn on the meter check that all symbol segments appear on the display see Display Symbols on page 4 The first time you turn on the meter the following 44 Chapter 3 symbol appears briefly showing that there is no test result in the memory This symbol will also appear after turning on the meter when the 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 for 5 seconds When the display flashes release the power Settings and Memory 45 Settings and Memory button The most recent test number appears 1 followed by the result Q Q 15 mg dL Order of test result Test result example most recent result first Each time the C button is pressed the next most recent test number will appear 2
27. pplied The 10 Chapter 1 intensity of the blue is read by the meter the darker the blue the higher the blood glucose level FRONT BACK white tip By black tip ee pink test square confirmation dot White Tip faces up as the test strip is inserted into the test strip holder Pink Test Square is where you apply the blood For detailed information refer to step 4 on page 32 White Pad absorbs any excess blood that may extend beyond the pink test square Do not apply blood directly to the white pad Black Tip faces down and helps the meter determine when the strip has been inserted Introduction 1 Introduction Confirmation Dot is read by the meter to determine the sample s glucose concentration If it turns completely blue this indicates an adequate volume of blood was applied IMPORTANT Test Strip Information For detailed information regarding SureStepPro Test Strips read the package insert e Use only SureStepPro Test Strips with the SureStep Hospital Meter e SureStepPro Test Strips are sensitive to heat light and moisture Keep them tightly sealed in their original bottle and store in a cool dry place below 30 C 86 F Do not refrigerate freeze or place in direct heat or sunlight e Do not use test strips after the expiration date printed on the bottle label Discard any unused test strips 4 months after opening Write the opened date on the bottle when you first ope
28. rror message Discard the test strip and repeat the test with a new test strip 26 Chapter 2 The control solution result appears in approximately 30 seconds IMPORTANT Do not remove the test strip until the countdown is complete LIFESCAN SureStep 6 Compare the control result with the control range printed on the SureStepPro Test Strip bottle or with your institution s established range 7 Remove the strip and dispose of it 8 Record the result Operation 27 Operation Control Solution Results When the control test result falls within the control range the meter has passed the QC check and can be used to test patient blood If the result falls outside the expected range repeat the test Results that fall outside the expected range may indicate e procedural error e control solution is expired contaminated beyond its discard date or inadequately mixed e code number in meter does not match code number on test strip bottle e dirty meter or test strip holder e problem with test strip expired damaged etc e control solution testing temperature outside the range of 18 30 C 64 86 F too much or too little control solution applied to test strip 28 Chapter 2 e testing control solutions at high altitude without applying correction factors read the SureStepPro Glucose Control Solution package insert for more information A CAUTION If the control result falls outs
29. sample color dots on the test strip bottle Color Chart If the color comparison indicates very low blood glucose repeat the test If the result is still lower than expected 14 Chapter 1 perform a quality control test A passing control result indicates the system is working properly A control result that is out of range indicates that the system may not be working properly Do not use the system to test patient blood glucose unless the control solution result falls within the expected range e If patient symptoms are inconsistent with monitoring results and procedural errors are ruled out follow your institution s policies for treating the symptoms and confirm the glucose measurement with a laboratory test e If you repeatedly get any error message obtain a result from a laboratory test Compare the test strip confirmation dot to the colors on the test strip bottle Color Chart and if necessary take appropriate precautions while awaiting the lab result Do not use the Color Chart as a replacement for a meter result Introduction 15 Introduction e Never make significant changes to a medication program or ignore signs and symptoms without consulting a physician e Failure to follow the instructions for use may result in inaccurate results Infection Control Use universal blood precautions All patient samples and materials with which they come in contact are considered biohazards and should be handled as if
30. sult on Display of last result off Settings and Memory 41 Settings and Memory Glucose Units The meter is pre set to display test results in milligrams per deciliter mg dL You may select to display results in millimoles per liter mmol L The mmol L results are displayed with a decimal point the mg dL results are not To change the units enter set up mode Press the blue power button to advance to the glucose units setting When the mg dL symbol appears press the green C button to change to mmol L mg dL mmol L illigrams per deciliter Millimoles per liter Beep Signals The meter uses beeping tones to signal various steps in the testing procedure These tones do not indicate that the procedures are being 42 Chapter 3 performed correctly The meter can detect some but not all errors in the test procedure e A single short beep confirms each step in the testing procedure e A single long beep accompanies error messages errors detected during the test procedure and a HI result e A three tone beep sounds when the meter displays a test result To turn off the beep signal enter the set up mode Press the blue power button to advance to the beep signal setting The meter will sound a three tone beep and flash the On symbol Press the green C button to turn off the beep signals g NFF Eig LI Beep signals on Beep signals off Settings and Memory 43 Settings and Memory A three tone beep s
31. sults as well as for infection control measures When to Clean the Meter e As required by your institution s infection control policies e If dirt blood or lint is present e When an error message appears and the troubleshooting solution indicates cleaning the meter 50 Chapter 4 Cleaning the Outside of the Meter Clean the outside of the meter with a cloth moistened with a 10 bleach solution Follow with a cloth moistened with water to remove residual bleach Dry the meter thoroughly A CAUTION Do not get water inside the meter Never immerse the meter or hold it under running water because it will damage the meter Cleaning the Test Strip Holder and Lens Area Clean the test strip holder cover and base lens area and contact points Use a 10 bleach solution followed by water Dry thoroughly A 10 bleach solution is 1 part bleach 5 25 sodium hypochlorite in 9 parts water A CAUTION Do not use alcohol glass cleaners or any cleansers containing abrasives phenol or Cleaning and Maintenance S Cleaning and Maintenance ammonia to clean the test strip holder or lens area because it will damage the parts 1 Remove the test strip holder Press down on the top of the test strip holder and slide it away from the meter Clean the test strip holder inside cover base clean both sides Remove debris by wiping the test strip holder cover and base with a cotton swab
32. ter optics fs E NOTE This message may also indicate that there is bleach residue on the inside of the test strip holder cover If necessary wipe with a cloth moistened with water to remove any residue then dry completely 5 Perform a quality control test to verify that the result is within the expected range 56 Chapter 4 Replacing the Batteries The SureStep Meter comes with two AAA alkaline batteries installed When this symbol appears the batteries are low and should be replaced as soon as possible If the symbol is flashing the batteries are dead and should be replaced immediately The meter cannot perform a test when the symbol is flashing Do not use rechargeable batteries E NOTE Low batteries dead batteries and battery removal will not affect the test results stored in memory 1 Turn off the meter and turn it over Cleaning and Maintenance 7 Cleaning and Maintenance 2 Remove the battery door Squeeze the tab and lift up 3 Remove the old batteries Gently tap the meter on the palm of your hand Never tap the meter against a hard surface 58 Chapter 4 4 Insert new batteries Insert two new AAA alkaline batteries matching the end of each battery with the signs inside the meter E NOTE The battery life depends on how quickly the meter is powered off after each test Under optimal conditions you can expect approximately 1000 tests 5 Replace the battery door Insert t
33. the test area but r strip NOTE Before cleaning compare color of test strip confirmation dot to Color Chart on test strip bottle If glucose level is very high or very low take appropriate steps to monitor patient and provide medical care e Repeat test with new test strip Do not move test strip after you insert it Remove test strip only when test is complete Etro 2 If you continue to get any error message obtain a laboratory result Take appropriate steps to monitor patient and provide medical care while awaiting laboratory result 3 Contact LifeScan for help LifeScan Healthcare Professional Line 1 800 524 7226 Troubleshooting 67 Troubleshooting Symbol Possible Cause What To Do The meter detected 1 Repeat test with new a temperature test strip Make sure uy problem meter and test strip are r at room temperature e Do not apply heat or cold to meter Operating temperature is 18 30 C 2 If you continue to get any error message obtain a laboratory result and e Compare color of test strip confirmation dot to Color Chart on test strip bottle to see if glucose level is very high or very low e Take appropriate steps to monitor patient and provide medical care while awaiting laboratory result 3 Contact LifeScan for help LifeScan Healthcare Professional Line 1 800 524 7226 68 Chapter 5 Symbol Possible Cause What
34. utions i icoei3h44 358 G68 bo adden baked 14 Infection Control 0 000 eee 16 Chapter 2 Operation 0 17 Coding the Meter 0 00 e eee eee 17 Quality Control Test 0 0 00 00 0040 20 Glucose Control Solution 21 a Performing a Quality Control Test 23 Control Solution Results 28 Linearity Test minei es NE Kaea KE a ends 29 Patient Blood Test 00 00 0005 30 Performing a Patient Blood Test 31 Patient Results 4000 8 ae as Maley ky 38 Chapter 3 Settings and Memory 39 Meter Settings esri a i a beth E 39 Meter Memory 00 ecu ce cence ertr 44 Using the Meter for the First Time 44 Recalling All Results in Meter Memory 45 Recalling Most Recent Result After Testing 47 Chapter 4 Cleaning and Maintenance 49 Cleaning nans maiaa Gass N OSG Oa ase a 50 When to Clean the Meter 50 Cleaning the Outside of the Meter 51 Cleaning the Test Strip Holder and Lens Area 51 Replacing the Batteries 04 57 Chapter 5 Troubleshooting 61 Error Messages 0 cece cece ene ees 63 Helpful Messages 00 000 cece nee 71 Meter Specifications 73 TN e E E A yea ainlints Acetate Mareen 75 Preface The SureStep Meter is a simple easy to use meter for monitoring blood glucose levels The SureStep Hospital Blood Glucose Monit
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