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Product catalog summary

Introduction

The OneTouch® SureStep® Hospital Meter is a device for measuring glucose levels in whole blood samples, intended for in vitro diagnostic use. It is part of LifeScan’s professional blood glucose monitoring system and should be used with OneTouch® Pro™ Test Strips. The system supports off-meter blood dosing to minimize pathogen transmission risks.

Specifications and Usage

The meter guides users with symbols and alerts for potential issues, storing up to 150 test results with date and time. It requires coding to match the test strip bottle before each test. Test strips are sensitive to environmental factors and must be stored properly.

Operation

Instructions cover coding the meter, performing quality control tests, and conducting patient tests. Results are displayed within 30 seconds, ranging from 0–500 mg/dL. A 'HI' result indicates glucose levels above 500 mg/dL, suggesting hyperglycemia.

Precautions

Unexpected results should be confirmed with laboratory tests. If low glucose levels are detected, the confirmation dot on the test strip should be checked. Persistent discrepancies require a quality control test to ensure accuracy.

Maintenance

Regular cleaning and battery replacement are necessary. The meter should be cleaned according to guidelines, and batteries replaced when indicated.

Troubleshooting

Error messages (Er1 through Er6) are detailed with solutions for common issues.

Infection Control

All samples and materials should be treated as biohazards, following institutional disposal policies.

Specifications and Features

The meter includes customizable features such as time and date settings, glucose units, beep signals, and test averages. It stores up to 150 test results and displays the last result automatically when turned on.

Changing Settings

Settings can be modified by entering set-up mode. Changes include time, date, glucose units, beep signals, and test averages.

Memory and Data Management

The meter stores the most recent 150 test results and calculates 14-day and 30-day averages, excluding control solution tests.

Cleaning and Maintenance

Regular cleaning with a 10% bleach solution is essential. Avoid alcohol or abrasive cleaners. Special care is needed for the test strip holder and lens area.

Battery Replacement

The meter uses two AAA alkaline batteries. Replace them promptly when the battery symbol appears. Battery replacement requires resetting the date and time but does not affect stored results.

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Catalog excerpts

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Operator's Guide Blood Glucose Monitoring System

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SS.book Page 90 Monday, July 17, 2006 10:44 AM

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SS.book Page 1 Wednesday, December 13, 2006 10:55 AM The OneTouch® SureStep® Hospital 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.

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SS.book Page 2 Wednesday, December 13, 2006 10:55 AM ©2006 LifeScan, Inc. All rights reserved. Contents covered by one or more of the following U.S. patents: 5,515,170, 5,526,120, 5,780,304, 5,968,836, 6,335,203, D367,109, and D371,198. Use of the monitoring device included herein and associated test strips is protected under the following U.S. patents: 4,935,346, 5,789,255, and 6,491,870. Purchase of this device does not act to grant a use license under these patents. Such a license is granted only when this device is used with OneTouch® Pro™ Test Strips. No test strip supplier other than LifeScan,...

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SS.book Page iii Wednesday, December 13, 2006 10:55 AM Table of Contents Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . .v About this Guide . . . . . . . . . . . . . . . . . . . . . . . . vi Here’s What You’ll Find in this Guide . . . . . . vi Conventions Used in this Guide . . . . . . . . . . . vii Help . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . viii Chapter 1: Introduction . . . . . . . . . . . . . . . 1 Learning the OneTouch® SureStep® Meter . . . . . 2 Display Symbols . . . . . . . . . . . . . . . . . . . . . . . . 4 OneTouch® Pro™ Test Strips . . . ....

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SS.book Page iv Wednesday, December 13, 2006 10:55 AM Linearity Test . . . . . . . . . . . . . . . . . . . . . . . . . . 33 Patient Blood Test . . . . . . . . . . . . . . . . . . . . . . . 34 Performing a Patient Blood Test . . . . . . . . . . 35 Patient Results . . . . . . . . . . . . . . . . . . . . . . . 43 Chapter 3: Settings and Memory . . . . . . . 45 Changing Settings . . . . . . . . . . . . . . . . . . . . . . . 45 Meter Memory . . . . . . . . . . . . . . . . . . . . . . . . . 55 Using the Meter for the First Time . . . . . . . . 56 Recalling All Results in Meter Memory . . . . . 56 Chapter...

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SS.book Page v Wednesday, December 13, 2006 10:55 AM Preface The OneTouch® SureStep® Hospital Meter is a simple, easy-to-use meter for monitoring blood glucose levels. The OneTouch® SureStep® Hospital Blood Glucose Monitoring System offers diabetes caregivers and patients off-meter blood dosing of the test strip. This design can help reduce the risk of transmission of bloodborne pathogens between patients, while providing accurate and reliable blood glucose results at the point of care. Preface v

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SS.book Page vi Wednesday, December 13, 2006 10:55 AM Preface About this Guide The OneTouch® SureStep® Hospital Meter Operator’s Guide provides detailed instructions on using and maintaining the OneTouch® SureStep® Hospital Meter. Although operating the meter is straightforward, it is important that you read the information presented in this manual, as well as the OneTouch® Pro™ Test Strip package insert. Here’s What You’ll Find in this Guide Chapter 1, Introduction, provides you with an overview of the meter and its display symbols, as well as general information about OneTouch® Pro™ Test Strips....

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SS.book Page vii Wednesday, December 13, 2006 10:55 AM included in this chapter is information on meter memory. 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 information that may be helpful. ◆ IMPORTANT: Contains information necessary to successfully perform the test. ▲ CAUTION: Alerts you to situations that could result in instrument damage, failure in a procedure,...

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SS.book Page viii Wednesday, December 13, 2006 10:55 AM Preface Help 1 Read through the section of the guide specific to the operation you are performing. Refer to the table of contents or index to locate information. 2 See Chapter 5 for troubleshooting information. 3 Call LifeScan Healthcare Professional Line at: 1 800 524-7226 (USA) or 1 888 353-0800 (Canada). viii

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SS.book Page 1 Wednesday, December 13, 2006 10:55 AM CHAPTER 1 Introduction The OneTouch® SureStep® Hospital Blood Glucose Meter is one component of LifeScan’s professional blood glucose monitoring system. When used with OneTouch® Pro™ Test Strips, the meter measures a patient’s blood glucose level from a whole blood sample taken at the bedside. Blood is applied directly to the test strip before the strip is inserted into the meter. A confirmation dot on the test strip helps you check that an adequate volume of sample was applied. Meter display symbols guide you through the test procedure. For...

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SS.book Page 2 Wednesday, December 13, 2006 10:55 AM Introduction Read the appropriate package insert for information regarding OneTouch® Pro™ Test Strips and OneTouch® Pro™ Glucose Control Solutions. Learning the OneTouch® SureStep® Meter Data Port allows you to transfer test results and other information to a computer.* FRONT C Button (green) Codes the meter, marks control solution results, changes meter settings, scrolls through memory. Power Button (blue) Turns meter on and off, accesses memory, scrolls through set-up mode. Contact Points Sense position of test strip. Display Shows test results...

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SS.book Page 3 Wednesday, December 13, 2006 10:55 AM CLOSED OPENED Test Strip Holder Protects the lens and holds the test strip. The insertion point is where the test strip is inserted. Cover Base Insertion Point ■ NOTE: The test strip holder is interchangeable—the same holder can be used in any SureStep® brand meter. BACK Meter Serial Number (Example) Battery Compartment Holds two AAA alkaline batteries. Introduction 3

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.