Lifescan SureStep Pro, Operator'S Manual

Page 1: ...Bedside Unit Operator s Guide...

Page 2: ......

Page 3: ...Step Pro Bedside Unit is for in vitro diagnostic use for the quantitative measurement of glucose in venous capillary arterial and neonatal whole blood samples It should not be used for the diagnosis o...

Page 4: ...40 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 o...

Page 5: ...Entering Information 6 Scanning a Barcode 8 System Beep Signals 9 SureStepPro Test Strips 9 Precautions 12 Infection Control 14 CHAPTER 2 Quality Control Test 15 When to Perform a Quality Control Test...

Page 6: ...an the Unit 53 Cleaning the Outside of the Unit 54 Cleaning the Test Strip Holder and Lens 54 Changing the Batteries 57 Adjusting the Screen Contrast 60 CHAPTER 6 Special Tests 61 Linearity Test 61 Un...

Page 7: ...ent and quality control data The SureStepPro System offers diabetes caregivers and patients off meter blood dosing of the test strip This design can help reduce the risk of transmission of blood borne...

Page 8: ...for a list of bedside unit options configured at the workstation What You ll Find in This Guide Chapter 1 Introduction provides you with an overview of the system and outlines basic operating instruc...

Page 9: ...are instructions on in service training when teaching new operators how to use the bedside unit to perform a glucose test Chapter 7 Troubleshooting lists error conditions that may occur or messages t...

Page 10: ...ocedure or possible inaccurate results Text within shaded boxes appears throughout this guide This information describes a specific workstation option and how it may affect bedside unit operation For...

Page 11: ...to the operation you are performing Refer to the table of contents and index to locate information 2 See Chapter 7 for error messages and troubleshooting information 3 Call LifeScan Healthcare Profes...

Page 12: ...Preface x...

Page 13: ...elps you check that an adequate volume of sample was applied The unit is equipped with a barcode scanner and a large touch sensitive display both of which allow you to enter operator patient and reage...

Page 14: ...ivity solutions Following a data transfer session reports can be generated and printed from the workstation The complete SureStepPro Professional Care Blood Glucose Management System includes a comput...

Page 15: ...e level on the test strip Contact points under the test strip holder sense the position and orientation of the test strip LCD screen displays test results andprompts that guide you through QC and pati...

Page 16: ...is inserted The base holds the test strip in place The cover protects the lens TEST STRIP HOLDER Opened The test strip holder is interchangeable the same holder may be used in any SureStep brand meter...

Page 17: ...edside unit and how it operates is determined by choices the system administrator makes within DataLink Data Management software running at the workstation It may be helpful for you to familiarize you...

Page 18: ...llows you to run a patient test Special Tests allows you to run linearity and unknown test solutions and perform in service testing Setup allows you to adjust the bedside unit s LCD contrast Review Da...

Page 19: ...ress Ok when you have completed the entry To delete the last character or characters entered press Del NOTE If left inactive the bedside unit will automatically shut off Press the power button to turn...

Page 20: ...d the bedside unit beeps Press Ok to confirm the entry CAUTION This product contains a laser Do not stare into the laser light or point it towards anyone s eyes while scanning a barcode The bedside un...

Page 21: ...detected in the test procedure as well as CRITICAL HIGH CRITICAL LOW and HIGH results This beep is also used at various times during the test strip insertion stages of the test SureStepPro Test Strip...

Page 22: ...o Applying Blood Sample to Test Strip on page33 White Pad absorbs 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 t...

Page 23: ...d CTL control code are printed on the test strip bottle label The CTL code encodes the test strip expiration date control solution ranges and linearity reference values When entering this information...

Page 24: ...p to 2 minutes to insert the test strip 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 Precautions Unexpecte...

Page 25: ...range 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...

Page 26: ...ntact are considered biohazards and should be handled as if capable of transmitting infection Follow proper precautions in accordance with your institution s policies when disposing of all materials C...

Page 27: ...test strip is necessary This is achieved at the start of each test when you enter the lot number and code for the current bottle of test strips If you are training a new operator on how to use the bed...

Page 28: ...is performed at the designated time a warning or lockout mode was selected Both modes display a message informing you that QC is due The warning mode allows you to continue with a patient test the lo...

Page 29: ...ny unused portion 3 months after opening Write the opened date on the vial when you first open it The control ranges printed on the SureStepPro Test Strip bottle label are for SureStepPro Control Solu...

Page 30: ...creen appears followed by the Status screen Check the battery status to ensure adequate power The battery and memory bars provide the approximate status of battery power and bedside unit memory If the...

Page 31: ...he configuration option setting you may or may not be required to enter your operator ID If your operator ID is required a configuration option may be set to remember your ID for up to 1 hour after th...

Page 32: ...atively scan the barcode on the control vial The control level s you are required to run have been selected by your system administrator They are labeled req d required at the Select QCTest screen Dep...

Page 33: ...a configuration option may have been selected which will allow you to enter a new control solution lot number at the bedside unit If you do not see the lot number in the list and the Enter Control Lo...

Page 34: ...trip and then insert the test strip Applying Control Solution to Test Strip CAUTION Applying too much or too little control solution may cause out of range results Apply the control solution as follow...

Page 35: ...ompletely blue indicating an adequate amount of control was applied If white patches or streaks are visible you have not applied enough control solution Repeat the application with a new test strip Wi...

Page 36: ...up to 2 minutes to insert the test strip after the control solution is applied If you insert the test strip after 2 minutes you may get an out of range result or an error message Discard the test stri...

Page 37: ...inue with the remaining required control levels Or if you wish to record additional information with the test result press Enter Notes and choose 1 to 3 comments from the list Press Ok and remove the...

Page 38: ...ormation on troubleshooting a failed QC test CAUTION If the control solution result fails repeat the test The system may not be functioning properly Do not use the system to test a patient s blood glu...

Page 39: ...ded in the statistical calculations for any QC reports generated by the system administrator If you have problems using the bedside unit to test the control solutions or if the bedside unit malfunctio...

Page 40: ...Quality Control Test 28...

Page 41: ...nly certified operators perform patient blood glucose testing using the SureStepPro System Follow your institution s policies for in service training to become a certified operator Performing a Patien...

Page 42: ...status to ensure adequate power The battery and memory bars provide the approximate status of battery power and bedside unit memory If there is insufficient battery power or memory to perform a test a...

Page 43: ...D is imperative for transferring the correct results to the medical record Depending on the configuration option setting you may or may not be required to enter your operator ID If your operator ID is...

Page 44: ...rate results you must enter the correct test strip lot number and code for each new test Depending on the configuration option setting you may or may not be required to enter the patient s ID A config...

Page 45: ...trip Applying Blood Sample to Test Strip Obtain a drop of blood Capillary blood can be obtained from puncturing the finger or heel using a lancing device The puncture site should be cleaned and thorou...

Page 46: ...llows 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 Heel Stick Carefully touch the center of...

Page 47: ...orbed by the test square 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 app...

Page 48: ...lied too much blood for an accurate result Repeat the application with a new test strip The confirmation dot on the back of the test strip should be completely blue If white patches or streaks are vis...

Page 49: ...y insert the test strip all the way into the test strip holder until it stops the confirmation dot should be facing down CAUTION If you fail to completely insert the test strip the test may start howe...

Page 50: ...p until the countdown is complete If an error message appears refer to Chapter 7 Troubleshooting for information A glucose range may have been defined by your system administrator Results that fall ab...

Page 51: ...s are followed the bedside unit will display HIGH 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...

Page 52: ...bedside unit to test patient samples or if the bedside unit malfunctions call the LifeScan Healthcare Professional Line at 1 800 524 7226 Depending on the configuration option setting you may be requi...

Page 53: ...transferred from the workstation to the bedside unit and QC and patient test results are transferred from the bedside unit to the workstation Your institution will establish a regular schedule for pe...

Page 54: ...serial port a connection module that is connected to a serial server or modem Using a Direct Infrared Port Connection To perform data transfer using a direct link with the workstation s infrared port...

Page 55: ...irectly with the workstation infrared port the message at the right appears Place the bedside unit s infrared communication port approximately 6 to 10 inches 15 to 25 centimeters from the workstation...

Page 56: ...n the bedside units and the workstation By placing the bedside unit in the connection module and dialing the workstation modem data is transferred through a standard analog phone line NOTE If a fax ma...

Page 57: ...tion module SureStepPro 1 2 Users Enter the workstation modem phone number then press Dial Once the phone number is entered it will remain in the bedside unit memory For subsequent sessions simply pre...

Page 58: ...e indicator light on the connection module blinks during transfer A message appears when data transfer is complete Remove the bedside unit from the connection module and press Cont to continue SureSte...

Page 59: ...screen indicating the status of the transfer When the transfer is complete the bedside unit beeps and a message appears Modem If a modem is detected the connection module automatically dials the recei...

Page 60: ...omplete the bedside unit beeps and a message appears Remove the bedside unit from the connection module and press Cont to continue If the bedside unit is off when you remove it from the connection mod...

Page 61: ...ailable the message Data Memory Low appears When the bedside unit memory is full a message appears informing you that there is no room for test data To continue using the bedside unit for testing you...

Page 62: ...Chapter 6 Special Tests If you select Patient Results you may specify a particular patient ID and see only the results for that patient or leave the ID field blank and see the results for all patient...

Page 63: ...ng with the most recently performed test The control solution level L N H is listed next to the QC result An F following the solution type indicates the result failed UA UE is listed next to unknown s...

Page 64: ...Lots to see all control linearity and unknown solution lot numbers with expiration dates currently entered in the system The last lot number used appears at the top of the list The solution type abbr...

Page 65: ...it dry and avoid exposing it to extremes in temperature and humidity Do not take apart the unit If you drop the unit inspect it for obvious damage Perform a quality control test prior to running a pat...

Page 66: ...er because it will damage the unit Cleaning the Test Strip Holder and Lens Clean the test strip holder cover and base lens area and contact points Use a 10 bleach solution followed by water CAUTION Do...

Page 67: ...left on the test strip holder may lead to an error message or an inaccurate high result Dry the test strip holder with a soft cloth or lint free tissue Close the holder and set it aside Using a cotto...

Page 68: ...older into the unit Push the holder until it clicks into place Turn on the bedside unit If an error appears check to make sure you installed the test strip holder correctly If necessary wipe the scann...

Page 69: ...on the screen You may want to change the batteries if the battery bar on the Status screen is low However the unit will continue to function properly until the LOW BATTERY message appears CAUTION Do n...

Page 70: ...f the bedside unit Turn the unit over Use a coin or screwdriver to loosen the screw from the battery compartment door Lift open the door Remove both batteries from the battery compartment and dispose...

Page 71: ...quickly the bedside unit is powered off after each test Under optimal conditions using the barcode scanner to enter information and turning off the bedside unit immediately after test results are disp...

Page 72: ...rrows to increase or decrease the LCD contrast A change occurs each time you press the arrow The gauge in the Low High bar gives you an approximate indication of the current setting When you are satis...

Page 73: ...In Service mode are uploaded to the DataLink workstation and can be viewed in the Datalog Report generated by the system administrator Linearity Test A Linearity Solution kit is available from LifeSc...

Page 74: ...Special Tests 62 Select Special Tests from the Main Menu Select Lin Unkn Test from the Special Tests menu Enter your operator ID 1 2 3...

Page 75: ...may not be required to enter your operator ID If your operator ID is required a configuration option may be set to remember your ID for up to 1 hour after the bedside unit is turned off If your ID app...

Page 76: ...ation option setting you may be required to enter the linearity solution lot number If you are not required to enter the lot number the Select Lot screen will not appear If you are required to enter t...

Page 77: ...he test strip CAUTION Applying too much or too little linearity solution may cause out of range results Gently shake the linearity solution vial A configuration option may have been selected which wou...

Page 78: ...f the test strip to verify it has turned completely blue indicating an adequate amount of solution was applied If white patches or streaks are visible you have not applied enough linearity solution Re...

Page 79: ...ed If you insert the test strip after 2 minutes you may get an out of range result or an error message Discard the test strip and repeat the test with a new test strip The test result appears in appro...

Page 80: ...f level 1 SureStepPro 1 2 Press Ok to display the Lin Unkn Test screen Proceed with the remaining replicates of level 1 SureStepPro 2 0 users press Next Level from the Linearity Level screen to contin...

Page 81: ...form a proficiency test on a solution for which you do not know the glucose value This type of testing may be required by your institution s accreditation organization Select Special Tests from the Ma...

Page 82: ...nter your operator ID If your operator ID is required a configuration option may be set to remember your ID for up to 1 hour after the bedside unit is turned off If your ID appears at the operator scr...

Page 83: ...lect the solution lot or identification number from the list displayed Depending on the configuration option setting you may be required to enter the unknown solution lot number If you are not require...

Page 84: ...cted which would allow you to enter a new unknown solution lot number at the bedside unit If you do not see the lot number in the list and the Enter Unk Lot button appears on the screen press the butt...

Page 85: ...test square If the white pad becomes completely saturated you have applied too much solution Repeat the application with a new test strip Check the confirmation dot on the back of the test strip to ve...

Page 86: ...an inaccurate low result IMPORTANT You have up to 2 minutes to insert the test strip after the solution is applied If you insert the test strip after 2 minutes you may get an inaccurate result or an...

Page 87: ...ment from the list Press Ok In Service Test Use the In Service mode to train and certify operators This mode is identical to the QC Test mode However In Service test results cannot be viewed in Review...

Page 88: ...al Tests menu Follow the instructions in Chapter 2 Quality Control Test beginning with step 4 Use the SureStepPro High Low and Normal Glucose Control Solutions The QC warning or lockout mode does not...

Page 89: ...test strip or the testing procedure These messages help in resolving some common problems that may occur during testing However the bedside unit cannot detect all problems When the unit does detect a...

Page 90: ...atory test Take appropriate steps to monitor the patient and provide medical care while awaiting the laboratory result After any test you can compare the test strip confirmation dot to the Color Chart...

Page 91: ...firmation dot turns completely blue Insert test strip within 2 min of applying blood 2 Checkthat sample hemat ocrit is within range adult 25 60 neonatal25 65 3 If you continue to get any error message...

Page 92: ...sure confirmation dot turns completely blue Wait approximately 1 min but not more than 2 min after applying sam ple before inserting test strip Do not alter test strips 2 If you continue to get any e...

Page 93: ...ip confirmation dot to Color Chart on test strip bottle If glucose level is very high or very low take appropri ate steps to monitor patient and provide medical care Repeat test with new test strip Do...

Page 94: ...and test strip are at room temperature Do not apply heat or cold to unit operating temperature is 18 30 C 2 If you continueto get any error message obtain a laboratory result and Compare color of test...

Page 95: ...Color Chart on test strip bottle If glucose level is very high or very low take appropri ate steps to monitor patient and provide medical care Repeat test with new test strip Make sure test strip hold...

Page 96: ...points compare color of test strip confirma tion dot to Color Chart on test stripbottle If glucose level isvery highor very low take appropriatesteps to monitor patient andprovide medical care Repeat...

Page 97: ...er of pink test square If white pad becomes satu rated you have applied too much blood Repeat application with new test strip If white patches or streaks appear on confirmation dot you have not applie...

Page 98: ...nnectionbetween connection module and modem 3 Contact LifeScan Check Connections at Workstation 1 Workstation modem not turned on 2 Bad connection between modem and wall jack 3 Workstation modem error...

Page 99: ...ppears firmly insert test strip until it stops Internal Communica tion Error Faulty internal communications Retry operation If problem persists do not use bedside unit Contact LifeScan Internal Error...

Page 100: ...mber and re enter it Invalid Strip Lot Number Strip lot number not correct Less than 10 digits were entered or code out of range Check lot number and re enter it Low Battery Battery power low Change b...

Page 101: ...line inspected QC Due for Bedside Unit in Less than Two Hours Unit will be in QC lockout if required QC not performed within 2 hours Perform required QC tests within 2 hours QC Due QCMissedor Failed Q...

Page 102: ...new strip Strip Lot Expired Test strip lot expired Enter and use new test strip lot Discard any remaining expired test strips ThisQC Test Not Required Continue QC solution level was not selected as re...

Page 103: ...within a nursing unit and directly affect how these bedside units function Patient Results Configuration Option Meaning Glucose units mg dL mmol L The units selected for displaying and reporting cont...

Page 104: ...es No If a patient test result falls outside the critical limits you may be required to select a comment which corresponds to the patient s current situation Configuration Option Meaning BU lockout if...

Page 105: ...ted you may enter test strip and control solution lot numbers that have not yet been entered in the system Require Solution LotNumber High Low Normal Unknown Linearity If selected you must select or e...

Page 106: ...een PatientIDrequired for all tests If selected a patient ID is required ID number string format patient and operator A string format was defined for all IDs entered at the bedside unit The string def...

Page 107: ...e label Result Display Numeric Value Pass Fail Only Pass Failavailablefor SureStepPro 2 0 only Determines how quality control test results are displayed QC Enforcement Warning Only Bedside Unit lockou...

Page 108: ...ng a failed QC test These messages allow you to record the steps taken to correct the problem You are required to select at least one message Failed QC Guiding Messages Messages that appear at a QC re...

Page 109: ...acy and precision data Bedside Unit Specifications power supply two size C 1 5 V alkaline batteries result range 0 500 mg dL display liquid crystal sample type whole blood calibration plasma equivalen...

Page 110: ...white only no color background 1 4 in border surrounding barcode symbol optimal Accepts the first 14 alphanumeric characters in a barcode that contains a maximum of 18 characters special characters i...

Page 111: ...ment Complies with Canadian ICES 001 CAN CSA C22 2 No 1010 1 92 Safety Requirements for Electrical Equipment for Measurement Control and Laboratory Use Part 1 General Requirements Complies with IEC 10...

Page 112: ...g Refer to Chapter 5 Care and Maintenance for cleaning precautions and detailed information on cleaning the bedside unit and test strip holder water 10 bleach 70 isopropyl alcohol 12 5 ammonia 10 Bacd...

Page 113: ...d application 33 36 c cleaning agents 100 barcode scanner 56 contact points 55 lens area 55 56 solution 54 test strip holder 54 55 Color Chart 12 13 39 configuration options 91 96 confirmation dot 10...

Page 114: ...ult control test 24 linearity test 67 p patient ID 31 patient results critical values 38 39 displayed 38 39 reviewing 50 patient test 29 40 power button 3 precautions 12 q QC lockout 15 quality contro...

Page 115: ...strip blood application 33 36 control application22 23 general information 9 12 inserting 23 37 66 74 lotnumber 21 32 64 72 test strip holder 3 4 cleaning 54 55 removing 54 transferring data 41 48 tr...

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Page 117: ...AW 061 296 01A 2002 LifeScan Inc For use with bedside units versions 1 2 and 2 0 09 02...