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Lifescan SureStep Blood Glucose Monitor Operator's Manual

Hospital blood glucose monitoring system
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  • Page 1 ® Hospital Meter Operator’s Guide company...
  • Page 3 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.
  • Page 4 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...

  • Page 5: Table Of Contents

    Table of Contents Preface ......v About this Guide ......vi Here’s What You’ll Find in this Guide .
  • Page 6 Performing a Quality Control Test ..23 Control Solution Results ....28 Linearity Test ......29 Patient Blood Test .

  • Page 7: Preface

    Preface The SureStep Meter is a simple, easy-to-use meter for monitoring blood glucose levels. The SureStep Hospital Blood Glucose Monitoring 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.

  • Page 8: About This Guide

    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.

  • Page 9: Conventions Used In This Guide

    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 NOTE Points out additional information that may be helpful.

  • Page 10: Help

    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). viii...

  • Page 11: Chapter 1: Introduction

    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.

  • Page 12: Learning The Surestep Meter

    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 Meter FRONT Display Shows test results and symbols that guide you through testing.
  • Page 13 1 800 524-7226 STATES: 1 888 353-0800 CANADA: Milpitas, California 95035 C22.2 No. 125; Risk Class 2 © LifeScan Inc. 1999 Test Strip Holder Protects the lens and holds the test strip. The insertion point is where the test strip is inserted.

  • Page 14: Display Symbols

    Carefully check that all symbols and symbol segments shown 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. 4 C h a p t e r 1...
  • Page 15 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). (Example) Code Number The number on the meter display must match the code number on the SureStepPro Test Strip bottle.
  • Page 16 Introduction Apply Blood Sample to the Test Strip This symbol prompts you to apply sample to the center of the pink test square. 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.
  • Page 17 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). (Example) I n t r o d u c t i o n 7...
  • Page 18 Introduction HI Result The meter reads HI in virtually all cases when a result is greater than 500 mg/dL (27.8 mmol/L). 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.
  • Page 19 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. (Example) Remove the Test Strip This symbol indicates that the test strip may have been inserted incorrectly or too quickly.

  • Page 20: Suresteppro Test Strips

    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.
  • Page 21 intensity of the blue is read by the meter—the darker the blue, the higher the blood glucose level. FRONT white tip white pink test square faces up as the test strip is White Tip inserted into the test strip holder. is where you apply the Pink Test Square blood.
  • Page 22 Introduction Confirmation Dot 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. • Use only SureStepPro Test Strips with the SureStep Hospital Meter.
  • Page 23 • 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.

  • Page 24: Precautions

    Introduction Precautions • Unexpected results should be confirmed by a laboratory test. • Various conditions may cause the meter to produce a very low test result (20 mg/dL [1.0 mmol/L] or less). • If the patient has symptoms of low blood glucose, follow your institution’s policy for treatment.
  • Page 25 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.

  • Page 26: Infection Control

    Introduction • Never make significant changes to a medication program or ignore signs and symptoms without consulting a physician. • 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 capable of transmitting...

  • Page 27: Chapter 2: Operation

    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.
  • Page 28 Operation 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. Turn on the meter by pressing the blue power button.
  • Page 29 Match the code numbers. The code number 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.

  • Page 30: Quality Control Test

    Operation the code number on the display matches the code number on the test strip bottle. 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...

  • Page 31: Glucose Control Solution

    • When you open a new bottle of test strips. • If a patient test has been repeated and the blood glucose results are still lower or higher than expected. • After cleaning the meter. • If there are other indications that the system is not working properly.
  • Page 32 Operation • Discard any unused portion 3 months after opening.Write the opened date on the vial when you first open it. • The control ranges printed on the test strip bottle are for SureStepPro Glucose Control Solutions only. • Store the control solution at room temperatures below 30°C (86°F).

  • Page 33: Performing A Quality Control Test

    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.
  • Page 34 Operation CAUTION For accurate results, the code number on the meter must match the code number on the test strip bottle. Apply a drop of control solution to the test strip as follows: CAUTION Applying too much or too little control solution may cause out-of-range results.
  • Page 35 • 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.
  • Page 36 Operation IMPORTANT If you fail to completely insert the test strip, the test may start; however, you may receive an out-of-range result. 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 error message.
  • Page 37 The control solution result appears in approximately 30 seconds. IMPORTANT Do not remove the test strip until the countdown is complete. Compare the control result with the control range printed on the SureStepPro Test Strip bottle, or with your institution’s established range.

  • Page 38: Control Solution Results

    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: •...

  • Page 39: Linearity Test

    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.

  • Page 40: Patient Blood Test

    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.

  • Page 41: Performing A Patient Blood Test

    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.
  • Page 42 Operation CAUTION For accurate results, the code number on the meter must match the code number on the test strip bottle. 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.
  • Page 43 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. CAUTION Avoid applying too much blood when using a syringe, or you may get an inaccurate, high result.
  • Page 44 Operation Pipette Touch the blood emerging from the tip of a narrow-bore pipette to the center of the pink test square. 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 Right Wrong...
  • Page 45 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. Firmly insert the test strip all the way into the test strip holder until it stops (the confirmation dot should be facing down).
  • Page 46 Operation CAUTION If you fail to completely insert the test strip, the test may start; however, you may receive an inaccurate, low result. CAUTION You have up to 2 minutes 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.
  • Page 47 The test result appears in approximately 30 seconds. IMPORTANT Do not remove the test strip until the countdown is complete. Remove the strip and dispose of it according to your institution’s policies and procedures. Record the result. If you are finished testing, you can turn off the meter.

  • Page 48: Patient Results

    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 C h a p t e r 2...

  • Page 49: Chapter 3: Settings And Memory

    Settings and Memory Meter Settings The SureStep Meter has three features which are pre-set but may be modified in set-up mode. Feature Display of last result Glucose units Beep signals CHAPTER 3 Pre-set Alternative mg/dL mmol/L S e t t i n g s a n d M e m o r y 39...
  • Page 50 Settings and Memory Entering Set-up Mode Turn off the meter by pressing the blue power button. Press and hold down the green C button. Press and release the blue power button while continuing to hold the C button. Release the C button. In the set-up mode, the current setting for each of the three changeable features is automatically displayed in sequence.
  • Page 51 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.
  • Page 52 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.
  • Page 53 performed correctly. The meter can detect some, but not all errors in the test procedure. • A single short beep confirms each step in the testing procedure. • A single long beep accompanies error messages, errors detected during the test procedure, and a HI result.

  • Page 54: Meter Memory

    Settings and Memory A three-tone beep sounds 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.

  • Page 55: Recalling All Results In Meter Memory

    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.
  • Page 56 Settings and Memory button. The most recent test number appears (1) followed by the result. Order of test result (most recent result first) Each time the C button is pressed, the next most recent test number will appear (2–10), followed by the result. Order of test result (2nd most recent result) 46 C h a p t e r 3...

  • Page 57: Recalling Most Recent Result After Testing

    If a previous test resulted in an error condition, the error will be stored in memory. Order of test result (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.
  • Page 58 Settings and Memory With the current test result displayed, press and hold the green C button. The previous result will appear. 48 C h a p t e r 3...

  • Page 59: Chapter 4: Cleaning And Maintenance

    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: • Keep the test strip holder and lens area clean. • Keep the meter dry and avoid exposing it to extremes in temperature and humidity.

  • Page 60: Cleaning

    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 results as well as for infection control measures.

  • Page 61: Cleaning The Outside Of The Meter

    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. CAUTION Do not get water inside the meter. Never immerse the meter or hold it under running water because it will damage the meter.

  • Page 62: Cleaning And Maintenance

    Cleaning and Maintenance ammonia to clean the test strip holder or lens area because it will damage the parts. 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.
  • Page 63 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.
  • Page 64 Cleaning and Maintenance 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. Wipe this area even if it doesn’t appear to be dirty.
  • Page 65 firmly in place and does not extend beyond the meter. Turn on the meter. If the following symbol appears after cleaning, check to see if the test strip holder C l e a n i n g a n d M a i n t e n a n c e 55...
  • Page 66 Cleaning and Maintenance was inserted correctly. The test strip holder may be blocking the meter optics. 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.

  • Page 67: Replacing The Batteries

    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.
  • Page 68 Cleaning and Maintenance Remove the battery door. Squeeze the tab and lift up. Remove the old batteries. Gently tap the meter on the palm of your hand. Never tap the meter against a hard surface. 58 C h a p t e r 4...
  • Page 69 Insert new batteries. Insert two new AAA alkaline batteries, matching the + end of each battery with the + signs inside the meter. 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.
  • Page 70 Cleaning and Maintenance 60 C h a p t e r 4...

  • Page 71: Chapter 5: Troubleshooting

    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.

  • Page 72: Troubleshooting

    Take appropriate steps to monitor the patient and provide medical care while awaiting the lab result. LifeScan Healthcare Professional Line: 1 800 524-7226 62 C h a p t e r 5...

  • Page 73: Error Messages

    Symbol Possible Cause The meter detected a problem with the color of the test strip. LifeScan Healthcare Professional Line: 1 800 524-7226 What To Do 1.Repeat test with new test strip, and • Apply blood to pink test square only.
  • Page 74 The meter detected a problem with the color of the test strip. (continued) LifeScan Healthcare Professional Line: 1 800 524-7226 64 C h a p t e r 5 What To Do 3.If you continue to get any error message,...
  • Page 75 Symbol Possible Cause The meter detected a problem with the test strip. LifeScan Healthcare Professional Line: 1 800 524-7226 What To Do 1.Repeat test with new test strip, and • Check test strip expiration date. Do not use expired test strips or test strips beyond discard date.
  • Page 76 Possible Cause The meter detected a problem with the test strip. (continued) LifeScan Healthcare Professional Line: 1 800 524-7226 66 C h a p t e r 5 What To Do 2.If you continue to get any error message, obtain a laboratory result, and •...
  • Page 77 Symbol Possible Cause The meter detected a problem with the position of the test strip. LifeScan Healthcare Professional Line: 1 800 524-7226 What To Do 1.Clean meter, especially contact points in lens area, but NOTE: Before cleaning, compare color of test...
  • Page 78 Symbol Possible Cause The meter detected a temperature problem. LifeScan Healthcare Professional Line: 1 800 524-7226 68 C h a p t e r 5 What To Do 1.Repeat test with new test strip. Make sure meter and test strip are at room temperature.
  • Page 79 Symbol Possible Cause The meter detected a problem with the optical system. LifeScan Healthcare Professional Line: 1 800 524-7226 What To Do 1.Clean meter, especially gray area inside test strip holder, but NOTE: Before cleaning, compare color of test strip confirmation dot to Color Chart on test strip bottle.
  • Page 80 Symbol Possible Cause The meter detected a problem with the electronics. LifeScan Healthcare Professional Line: 1 800 524-7226 70 C h a p t e r 5 What To Do 1.Wipe contact points in lens area with cloth moistened with water to remove residual bleach.

  • Page 81: Helpful Messages

    Not enough sample on test strip, or test strip was inserted too quickly. LifeScan Healthcare Professional Line: 1 800 524-7226 Meaning What To Do Remove test strip. When “Insert test strip” symbol appears, firmly insert...
  • Page 82 Troubleshooting Symbol LifeScan Healthcare Professional Line: 1 800 524-7226 72 C h a p t e r 5 Meaning What To Do If symbol is Replace batteries (see constant, batteries page 57). are low. If symbol is flashing, batteries are dead.

  • Page 83: Meter Specifications

    Specifications The performance of the system has been evaluated under the conditions listed below. See the SureStepPro Test Strip package insert for accuracy and precision data. power supply: result range: display: memory: sample type: calibration: two AAA alkaline batteries 0–500 mg/dL (0–27.8 mmol/L) liquid crystal 10 test results...
  • Page 84 hematocrit range: dimensions: weight: operating temperature: operating humidity: altitude: 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.]...

  • Page 85: Index

    Index applying – blood 32 blood, symbol 6 control solution 24 battery compartment 3 – replacing 57 symbol 10 – beep signals 42 blood application 32 test, performing 31 C button 2 cleaning contact points 54 lens area 54 test strip holder 51 code number 5 checking 23 setting 17...
  • Page 86 display of last result 41 – display symbols 4 error messages 9 glucose control solution See control solution glucose units 42 high result 38 infection control 16 lens area 2 cleaning 54 linearity test 29 – memory 44 messages – error 63 helpful 71 meter...
  • Page 87 – symbols, meter 4 test results 7 control solution 27 high 8 linearity 30 patient 37 test strip holder 3 – cleaning 51 test strip symbol insert 6 remove 9 – test strips 10 Color Chart 13 units, glucose 42...
  • Page 89 AW 050-097-03A ©2002 LifeScan, Inc. 11/02...

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