Lifescan SureStep Pro User Manual

Bedside Unit Operator’s GuideBU.book Page 1 Monday, October 28, 2002 11:14 PM

PrefaceviiiConventions Used in This Guide NOTEPoints out additional information that may be helpful.◆IMPORTANTContains information necessary to succes

Troubleshooting88If you cannot resolve a problem, call LifeScan Healthcare Professional Line: 1 800 524-7226 (USA)1 888 353-0800 (Canada) Invalid Oper

89If you cannot resolve a problem, call LifeScan Healthcare Professional Line: 1 800 524-7226 (USA)1 888 353-0800 (Canada)No Room for New Test DataBed

Troubleshooting90If you cannot resolve a problem, call LifeScan Healthcare Professional Line: 1 800 524-7226 (USA)1 888 353-0800 (Canada) Shake vial a

91APPENDIX ABedside Unit Configuration OptionsFollowing is a list of workstation options configured by your System Administrator. These options apply

Bedside Unit Configuration Options92Bedside UnitCritical Warning MessagesLower Limit ____Upper Limit ____Notes that appear at the patient test result

93Nursing unit to which bedside unit is assignedEach bedside unit is assigned to a particular nursing unit. Do not use the bedside unit outside the de

Bedside Unit Configuration Options94Operator and IDsConfiguration Option Meaning❑ ID required for all tests❑Maintain ID for ____ minutes after power o

95Quality ControlConfiguration Option MeaningGlucose units❍ mg/dL❍ mmol/LThe units selected for displaying and reporting control and blood glucose res

Bedside Unit Configuration Options96QC Test Period❍ Time of day____❍ Elapsed time ____ hoursFrequency of performing a QC test is defined as a set time

97SpecificationsThe performance of the system has been evaluated under the conditions listed below. Refer to the SureStepPro Test Strips package inser

ixHelp1. Read through the section of the guide specific to the operation you are performing. Refer to the table of contents and index to locate inform

Specifications98operating humidity: 30%–70% relativehumidity (noncondensing)altitude: up to 10,000 ft (3048 m)[For more information, read the SureStep

99The SureStepPro Blood Glucose Bedside Unit complies with the following standards:• CAN/CSA - C22.2 No. 601.1-94 Medical Electrical Equipment - Part

Specifications100Cleaning AgentsThe following compounds can be used to clean the exterior only of the bedside unit. Follow the instructions for use on

101aapplyingblood 33–36control solution 22–23bbarcode scanner 3cleaning 56using 8barcode specifications 98barcode specs 98batterieschanging 57–59statu

Index102iIDoperator 7patient 31infection control 14insert test strip 23, 37, 66, 74in-service test 75–76llaser information ii, 4LCD screen 3contrast 6

103ttestin-service 75–76linearity 61–68patient 29–40quality control 18–27unknown solution 69–75test stripblood application 33–36control application 22

BU.book Page 104 Monday, October 28, 2002 11:14 PM

AW 061-296-01A©2002 LifeScan, Inc.For use with bedside units, versions 1.2 and 2.0.09/02BU.book Page 105 Monday, October 28, 2002 11:14 PM

PrefacexBU.book Page x Monday, October 28, 2002 11:14 PM

1CHAPTER 1IntroductionThe SureStepPro Bedside Unit is one component of LifeScan’s professional blood glucose monitoring system. When used with SureSte

Introduction2The bedside unit stores patient and quality control data in internal memory. A bi-directional data transfer, performed with the workstati

3The Bedside Unit▲CAUTIONDo not stare into the barcode scanner or point it towards anyone’s eyes while the laser light is on.Power button turns the un

Introduction4 The insertion point is the area where the test strip is inserted.The base holds the test strip in place.The cover protects the lens.TEST

5General Operating InformationLifeScan recommends that only certified operators in the hospital or clinic perform blood glucose testing using the Sure

Introduction6A Main Menu lets you select from six different functions.Entering InformationSelect an item from a list by touching the appropriate area

7Manually enter IDs or lot numbers by pressing the appropriate characters on the screen. Both alpha and numeric characters are available for data entr

BU.book Page 2 Monday, October 28, 2002 11:14 PM

Introduction8Scanning a Barcode To scan a barcode, hold the barcode label parallel to and approximately 6 to 10 inches from the unit’s scanner. Press

9System Beep SignalsThe SureStepPro Bedside Unit uses beeping signals to indicate various stages in the testing procedure. These signals do not indica

Introduction10sample was applied. The intensity of the blue is read by the bedside unit—the darker the blue, the higher the glucose level. White Tip f

11◆IMPORTANT Test Strip InformationFor detailed information regarding SureStepPro Test Strips, read the package insert.• Use only SureStepPro Test Str

Introduction12• Use each test strip immediately after removing it from the bottle.• Do not use test strips that are bent, torn, cut, or damaged in any

13– If the confirmation dot is completely blue, compare it to the sample color dots on the test strip bottle Color Chart. If the color comparison indi

Introduction14Infection ControlUse universal blood precautions.* All patient samples and materials with which they come in contact are considered bioh

15CHAPTER 2Quality Control TestThree levels of SureStepPro Glucose Control Solution are available to check that the SureStepPro Bedside Unit and SureS

Quality Control Test16 When to Perform a Quality Control Test• As required by your institution’s quality control policy or local regulatory requiremen

17Glucose Control SolutionsUse SureStepPro Glucose Control Solutions with the SureStepPro Bedside Unit and SureStepPro Test Strips only. ◆IMPORTANT Co

iThe SureStep®Pro Bedside Unit is for in vitro diagnostic use for the quantitative measurement of glucose in venous, capillary, arterial, and neonatal

Quality Control Test18Performing a Quality Control TestPress the power button to turn on the unit. A start-up screen appears...followed by the Stat

19Select QC Test from the Main Menu. Enter your operator ID, either by pressing the touch screen or using the barcode scanner. Refer to page 8 for inf

Quality Control Test20Select the control level you wish to run; for example, High.Select the control lot number from the list displayed. The last cont

21Select the test strip lot number (and code) from the list displayed. The last test strip lot number selected appears at the top of the list. Use the

Quality Control Test22The QC Test screen appears with messages prompting you to apply the control to the test strip and then insert the test strip.App

23If the white pad becomes completely saturated, you have applied too much control solution. Repeat the application with a new test strip.• Check the

Quality Control Test24◆IMPORTANTIf you fail to completely insert the test strip, the test may start; however, you may receive an out-of-range result.

25◆IMPORTANTDo not remove the test strip until the countdown is complete. • If the result is PASSED, press Ok, remove the strip, and continue with th

Quality Control Test26• If the result is FAILED, press Enter Notes and choose from 1 to 3 comments. This will be recorded with the failed result. Pres

27 NOTEResults tagged with the comment “Procedure Err” are not included in the statistical calculations for any QC reports generated by the system adm

ii▲CAUTIONThis product contains a barcode scanner. It is a class II laser which operates at 680 nm and uses 0.88 mW of energy. This product meets 21 C

Quality Control Test28BU.book Page 28 Monday, October 28, 2002 11:14 PM

29CHAPTER 3Patient TestLifeScan recommends that only certified operators perform patient blood glucose testing using the SureStepPro System. Follow yo

Patient Test30A start-up screen appears...followed by the Status screen.Check the battery status to ensure adequate power. The battery and memory b

31Enter your operator ID either by pressing the touch screen or using the barcode scanner. Refer to page 8 for information on scanning a barcode.Enter

Patient Test32Select the test strip lot number (and code) from the list displayed. The last test strip lot number selected appears at the top of the l

33The Patient Test screen appears with messages prompting you to apply blood to the strip and then insert the test strip.Applying Blood Sample to Test

Patient Test34Apply the blood to the test strip as follows:Finger StickCarefully touch the center of the pink test square to the drop of blood on the

35SyringeTouch the tip of the syringe to the center of the pink test square. Gently apply pressure to the plunger. As the blood emerges from the tip o

Patient Test36Check 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 com

37▲CAUTIONDo 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

iiiTable of ContentsPreface . . . . . . . . . . . . . . . . . . . . . . . . . . . . vAbout This Guide . . . . . . . . . . . . . . . . . . . viWhat

Patient Test38The test result appears in approximately 30 seconds.◆IMPORTANTDo not remove the test strip until the countdown is complete.If an error m

39• CRITICAL LOW indicates a result below the range.• HIGH indicates a result greater than 500 mg/dL. ◆IMPORTANTWhen the result is greater than 500 mg

Patient Test40Press Enter Notes and choose 1 to 3 comments that correspond to the patient’s current situation. Press Ok.Or press Menu and continue tes

41CHAPTER 4Data ManagementTransferring Data to the WorkstationData transfer is required periodically to exchange information between the workstation a

Data Management42You may transfer data using: • a direct infrared link with the workstation’s infrared port• a connection module that is directly conn

43The bedside unit is ready for the communication link to be established. If the bedside unit has been configured to communicate directly with the wor

Data Management44A series of messages are displayed on the bedside unit screen indicating the status of the transfer. When the transfer is complete, t

45Select Transfer Data from the Main Menu.The bedside unit is ready for the communication link to be established. A message appears instructing you to

Data Management46up to 20 times at 30-second intervals before it times out.Messages appear on the screen indicating the status of the connection. The

47EthernetIf you are transferring data over an Ethernet network using a serial server, the transfer begins immediately. A series of messages are displ

Table of ContentsivCHAPTER 4–Data Management . . . . . . . 41Transferring Data to the Workstation . . . . 41Using a Direct Infrared Port Connecti

Data Management48If the workstation modem phone number was not pre-programmed, enter the phone number, then press Dial. If the phone number appears on

49Bedside Unit MemoryThe bedside unit stores up to 2500 QC and patient test results in its memory. Additionally, the lot IDs for test strips and contr

Data Management50Press Review Data from the Main Menu.Select Patient Results, QC/Lin/Unkn, Test Strip Lots, or Reagent Lots.Lin and Unkn refer to Line

51results marked with the Procedure Err comment will appear as Proc Err. • If you select QC/Lin/Unkn, you may enter an operator ID and see the results

Data Management52• Select Test Strip Lots to see all test strip lot numbers with expiration dates currently entered in the system. The last lot number

53CHAPTER 5Care and MaintenanceGeneral CareTo keep the bedside unit in good operating condition, you must keep it clean and handle it with care.Follow

Care and Maintenance54Cleaning the Outside of the UnitClean the outside of the unit with a cloth moistened with a 10% bleach solution. Follow with a c

55Wipe the test strip holder cover and base with a cotton swab or soft cloth moistened with a 10% bleach solution. Be sure to thoroughly wipe the area

Care and Maintenance56Dry the lens area gently with a clean, soft, lint-free cloth or tissue. Remove any lint.Slide the closed test strip holder into

57Changing the BatteriesThe SureStepPro Bedside Unit is powered by two size C alkaline batteries. Change the batteries when the LOW BATTERY message ap

vPrefaceSureStepPro is LifeScan’s integrated blood glucose management system for testing, tracking, and managing patient and quality control data.The

Care and Maintenance58Press the power button to turn off the bedside unit.Turn the unit over. Use a coin or screwdriver to loosen the screw from the b

59Insert two new size C batteries, matching the positive (+) end of each battery with the + signs inside the battery compartment. NOTEThe battery life

Care and Maintenance60Adjusting the Screen ContrastYou can increase or decrease the LCD screen contrast.Select Setup from the Main Menu.Press the arro

61CHAPTER 6Special TestsThe Special Tests function allows you to perform tests that are not routinely performed, such as a linearity test and an unkno

Special Tests62Select Special Tests from the Main Menu.Select Lin/Unkn Test from the Special Tests menu.Enter your operator ID.123BU.book Page 62 Mo

63Start by selecting Lin 1.Select the Linearity Solution lot number from the list displayed.Alternatively, scan the barcode on the linearity solution

Special Tests64Select the test strip lot number (and code) from the list displayed. The last test strip lot number selected appears at the top of the

65▲CAUTIONTo obtain accurate results, you must enter the correct test strip lot number (and code) for each new test.SureStepPro 2.0 users, press Ok to

Special Tests66• Touch a drop of linearity solution to the center of the pink test square. If the white pad becomes completely saturated, you have app

67◆IMPORTANTIf you fail to completely insert the test strip, the test may start; however, you may receive an out-of-range result.◆IMPORTANTYou have up

PrefaceviAbout This GuideThe SureStepPro Bedside Unit Operator’s Guide provides detailed instructions on using and maintaining the SureStepPro Bedside

Special Tests68If you wish to record additional information with the test result, press Enter Notes and choose a comment from the list. Press Ok.SureS

69Unknown Solution TestPeriodically, you may be asked to perform a proficiency test on a solution for which you do not know the glucose value. This ty

Special Tests70Enter your operator ID.Depending on the configuration option setting, you may or may not be required to enter your operator ID.If your

71Select an option to identify your unknown solution, for example Unkn A.Select the solution lot (or identification) number from the list displayed. D

Special Tests72Select the test strip lot number (and code) from the list displayed. The last test strip lot number selected appears at the top of the

73▲CAUTIONTo obtain accurate results, you must enter the correct test strip lot number (and code) for each new test.Apply the unknown solution to the

Special Tests74Firmly insert the test strip all the way into the test strip holder until it stops (the confirmation dot should be facing down). ◆IMPOR

75Press Ok to display the Lin/Unkn Test screen. Or, if you wish to record additional information with the test result, press Enter Notes and choose a

Special Tests76Select In-Service Mode from the Special Tests menu.Follow the instructions in Chapter 2, Quality Control Test, beginning with step 4. U

77CHAPTER 7TroubleshootingThe SureStepPro Bedside Unit displays prompts and error messages to indicate the system has detected a problem with its inte

viiChapter 5, Care and Maintenance, instructs you on how to clean the bedside unit and test strip holder and change the batteries. Chapter 6, Special

Troubleshooting78If you cannot resolve a problem, call LifeScan Healthcare Professional Line: 1 800 524-7226 (USA)1 888 353-0800 (Canada) ▲ CAUTIONWhi

79If you cannot resolve a problem, call LifeScan Healthcare Professional Line: 1 800 524-7226 (USA)1 888 353-0800 (Canada)Error Messages ERRORPOSSIBLE

Troubleshooting80If you cannot resolve a problem, call LifeScan Healthcare Professional Line: 1 800 524-7226 (USA)1 888 353-0800 (Canada) Error 2 Test

81If you cannot resolve a problem, call LifeScan Healthcare Professional Line: 1 800 524-7226 (USA)1 888 353-0800 (Canada)Error 3 Test StripThe bedsid

Troubleshooting82If you cannot resolve a problem, call LifeScan Healthcare Professional Line: 1 800 524-7226 (USA)1 888 353-0800 (Canada) Error 4 Temp

83If you cannot resolve a problem, call LifeScan Healthcare Professional Line: 1 800 524-7226 (USA)1 888 353-0800 (Canada)Error 5Meter OpticsThe bedsi

Troubleshooting84If you cannot resolve a problem, call LifeScan Healthcare Professional Line: 1 800 524-7226 (USA)1 888 353-0800 (Canada) Error 6Syste

85If you cannot resolve a problem, call LifeScan Healthcare Professional Line: 1 800 524-7226 (USA)1 888 353-0800 (Canada)Unexpected Messages and Obse

Troubleshooting86If you cannot resolve a problem, call LifeScan Healthcare Professional Line: 1 800 524-7226 (USA)1 888 353-0800 (Canada) Check Connec

87If you cannot resolve a problem, call LifeScan Healthcare Professional Line: 1 800 524-7226 (USA)1 888 353-0800 (Canada)Data Memory LowLess than 100