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It should not be used for the diagnosis of diabetes. ^ CAUTION This 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 CFR (Code of Federal Regulations) 1040.10* laser light when activated. Do not stare into the laser beam. Refer to page 8 of this guide for information and instructions on barcode scanner operation. ©2002, 1996 LifeScan, Inc. All rights reserved. The system described herein is covered by one or more of the following US patents: D392,740, 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. *A Food and Drug Administration (FDA) regulation established for any product that contains a laser. Table of Contents Preface .. ... ...... . . . . . . . . . . . . . . . . . v AboutThisGuide . .. ... .. . . . . . . . . . . . vi What You’ll Find in This Guide. . . . . . . vi Conventions Used in This Guide . . . . . . . viii Help . . . ... ..... . . . . . . . . . . . . . . . . . . ix CHAPTER 1–Introduction . . . ... . . . . . . . 1 The Bedside Unit . .. ... ... . . . . . . . . . . . . 3 General Operating Information . . . . . . . . . . 5 Entering Information . . . . . . .. . . . . . . . . 6 Scanning a Barcode . . . . . . . . . . . . . . . . . 8 SystemBeep Signals.. ... . .. . . . . . . . . . 9 SureStepProTestStrips . . . . . . .. . . . . . . . . 9 Precautions . . . . . . .. .. . . . . . . . . . . . . . . 12 InfectionControl .. ... .. . . . . . . . . . . . 14 CHAPTER 2–Quality Control Test . . . . . . 15 When to Perform a Quality Control Test . . 16 Glucose Control Solutions . . . . . . . . . . . . . 17 Performing a Quality Control Test . . . . . . . 18 Applying Control Solution to Test Strip. 22 CHAPTER 3–PatientTest ..... . . . . . . . . 29 Performing a PatientTest . . . . . . . . . . . . . 29 Applying Blood Sample to Test Strip . . . 33 Table of Contents CHAPTER 4–DataManagement . .. .. . . 41 Transferring Data to the Workstation . . . . 41 Using a Direct Infrared Port Connection 42 Using the Connection Module. . . . . . . . 44 Bedside UnitMemory... ... .. . . . . . . . . 49 Accessing Memory to Review Data . . . . 49 CHAPTER 5–Care and Maintenance . . . . 53 General Care .. ........ . . . . . . . . . . . . . 53 When toClean 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 LinearityTest .. ...... .. . . . . . . . . . . . . 61 Unknown Solution Test . . . . . . . . . . . . . . 69 In-Service Test . . . . . . .. .. . . . . . . . . . . . 75 CHAPTER 7–Troubleshooting . . . . . . . . 77 ErrorMessages .. ...... .. . . . . . . . . . . . 79 Unexpected Messages and Observations . . 85 APPENDIX A–Bedside Unit ConfigurationOptions .. ..... . . . . . . 91 Specifications . . . . . . .. .. . . . . . . . . . . . 97 Bedside UnitSpecifications.. ..... . . . . . 97 Barcode Specifications... ... .. . . . . . . . . 98 CleaningAgents ....... . . . . . . . . . . . . 100 Index ...... ... . . . . . . . . . . . . . . . . . . 101 Preface SureStepPro is LifeScan’s integrated blood glucose management system for testing, tracking, and managing patient 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 pathogens between patients, while providing accurate and reliable blood glucose results at the point of patient care. Preface About This Guide The SureStepPro Bedside Unit Operator’s Guide provides detailed instructions on using and maintaining the SureStepPro Bedside Unit. Because bedside unit settings will vary depending on how the unit is configured, you will benefit by becoming familiar with the configuration options. For more detailed information on configuration options, ask your system administrator or refer to Appendix A, Bedside Unit Configuration Options, 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 instructions. Chapter 2, Quality Control Test, guides you through the steps of performing a quality control test. Chapter 3, Patient Test, guides you through the steps of performing a patient blood test. C...