Lifescan SureStep Pro manual Type BF Equipment

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The SureStepPro Blood Glucose Bedside Unit complies with the following standards:

•CAN/CSA - C22.2 No. 601.1-94 Medical Electrical Equipment - Part 1: General Requirements for Safety (Complies with UL 2601-1 and IEC 601-1)

•CAN/CSA - C108.6-M91 (CISPR 11:1990) Limits and Methods of Measurement of Electromagnetic Disturbance Characteristics in Industrial, Scientific and Medical (ISM) Radio-Frequency Equipment (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 1010-1)

•CAN/CSA - C22.2 No. 601.1.2-94 Medical Electrical Equipment Part 1: General Requirements for Safety-2. Collateral Standard: Electromagnetic Compatibility - Requirements and Tests (Complies with IEC 601-1-2)

Type BF Equipment

• Internally powered equipment

•No patient-applied parts

•This unit is not suitable for use in the presence of a flammable anaesthetic mixture with air, oxygen, or nitrous oxide.

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Contents Bedside Unit Operator’s Guide Page It should not be used for Diagnosis of diabetes 2002, 1996 LifeScan, Inc. All rights reserved Table of Contents Table of Contents Preface About This Guide PrefaceVii Conventions Used in This Guide Help Preface Introduction Introduction Front Bedside UnitTest Strip Holder General Operating Information Main Menu lets you select from six different functions Page Scanning a Barcode SureStepPro Test Strips Frontback Important Test Strip Information Precautions Page Infection Control Quality Control Test Quality Control Test When to Perform a Quality Control TestGlucose Control Solutions Performing a Quality Control Test Page Select the control level you wish to run for example, High Select the test strip lot Applying Control Solution to Test Strip Page Quality Control Test Page If the result is Failed Page Quality Control Test Performing a Patient Test Patient TestPatient Test Page Patient Test Applying Blood Sample to Test Strip Apply the blood to the test strip as follows Syringe Front Page Critical High indicates a result above the range Page Patient Test Transferring Data to the Workstation Data ManagementData Management Page Using the Connection Module Select Transfer Data from the Main Menu SureStepPro 2.0 Users Ethernet Last Data Transfer mm/dd/yy hhmm Failed Bedside Unit Memory If you select Patient If you select QC/Lin/Unkn Press Menu to proceed, or turn off the bedside unit General Care Care and MaintenanceCleaning the Test Strip Holder and Lens Cleaning the Outside of the UnitContact points Lens area Care and Maintenance Changing the Batteries Care and Maintenance Page Adjusting the Screen Contrast Linearity Test Special TestsSpecial Tests Select Lot # Special Tests Page Special Tests Page Special Tests Unknown Solution Test Special Tests HIGH003 Special Tests Page Do not remove the test strip until the countdown is complete In-Service Test Select In-Service Mode from Special Tests menu Troubleshooting Troubleshooting Error Possible Solution Cause Error MessagesError Possible Solution Clean bedside unit Detected a Make sure test strip With water to remove Unexpected Messages and Observations Message Possible Solution CauseCheck Data Re-enter your ID using New Test Memory full Space Data Shake vial Bedside unit is Patient Results Bedside Unit Configuration OptionsBedside Unit Bedside Unit Configuration OptionsNot need to enter Operator and IDs Quality Control QC Test Period Frequency of performing a Bedside Unit Specifications SpecificationsBarcode Specifications SpecificationsType BF Equipment Cleaning Agents Index Index Unknown solution test Workstation Page For use with bedside units, versions 1.2