Lifescan Blood Glucose Monitor User Manual

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Hospital Meter Operator’s Guide

The SureStep 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.

The system described herein is covered by one or more of the following US patents: D371,198, 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.

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 SureStep Meter . . . . . . . . . . . . . . . . 2

Display Symbols . . . . . . . . . . . . . . . . . . . . . . . . 4

SureStepPro Test Strips . . . . . . . . . . . . . . . . . . . 10

Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Infection Control . . . . . . . . . . . . . . . . . . . . . . 16

Chapter 2: Operation . . . . . . . . . . . . . . . . .17

Coding the Meter . . . . . . . . . . . . . . . . . . . . . . . . 17

Quality Control Test . . . . . . . . . . . . . . . . . . . . . 20

Glucose Control Solution . . . . . . . . . . . . . . . . 21

iii

Performing a Quality Control Test . . . . . . . . . 23

Control Solution Results . . . . . . . . . . . . . . . . 28

Linearity Test . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Patient Blood Test . . . . . . . . . . . . . . . . . . . . . . . 30

Performing a Patient Blood Test . . . . . . . . . . 31

Patient Results . . . . . . . . . . . . . . . . . . . . . . . 38

Chapter 3: Settings and Memory . . . . . . . .39

Meter Settings . . . . . . . . . . . . . . . . . . . . . . . . . . 39

Meter Memory . . . . . . . . . . . . . . . . . . . . . . . . . 44

Using the Meter for the First Time . . . . . . . . 44

Recalling All Results in Meter Memory . . . . . 45

Recalling Most Recent Result After Testing . 47

Chapter 4: Cleaning and Maintenance . . . 49

Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50

When to Clean the Meter . . . . . . . . . . . . . . . . 50

Cleaning the Outside of the Meter . . . . . . . . . 51

Cleaning the Test Strip Holder and Lens Area 51

Replacing the Batteries . . . . . . . . . . . . . . . . . . . 57

Chapter 5: Troubleshooting . . . . . . . . . . .61

Error Messages . . . . . . . . . . . . . . . . . . . . . . . . . 63

Helpful Messages . . . . . . . . . . . . . . . . . . . . . . . 71

Meter Specifications . . . . . . . . . . . . . . . . . 73

Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . .75

Preface

The SureStep Meter is a simple, easy-to-use meter for monitoring blood glucose levels.

The SureStep Hospital Blood Glucose Monitoring System offers diabetes caregivers and patients off-meter blood dosing of the test strip. The 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.

About this Guide

The SureStep Hospital Meter Operator’s Guide provides detailed instructions on using and maintaining the SureStep Meter. Although operating the meter is straightforward, it is important that you read the information presented in this manual, as well as the SureStepPro Test Strip package insert.

Here’s What You’ll Find in this Guide

Chapter 1, Introduction, provides you with an overview of the meter, its display symbols, as well as general information about SureStepPro Test Strips.

Chapter 2, Operation, includes instructions for coding the meter and performing a quality control test and a patient test.

Chapter 3, Settings and Memory, provides information on the various meter settings and how you can change them. Also 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 additional 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, or possible inaccurate results.

vii

Help

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 Customer Service toll free at:

1 800 524-7226 (USA) or 1 888 353-0800 (Canada).

viii

CHAPTER 1

Introduction

The SureStep® Hospital Blood Glucose Meter is one component of LifeScan’s professional blood glucose monitoring system. When used with SureStepPro 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 accurate results, use only SureStepPro Test Strips with the SureStep Hospital Meter. SureStepPro Low, Normal, and High Glucose

Introduction

Control Solutions are available to check that the meter and test strips are working together properly.

Read the appropriate package insert for information regarding SureStepPro Test Strips and SureStepPro Glucose Control Solutions.

Learning the SureStep Meter

FRONT

Chapter 1

Display

Shows test results and symbols that guide you through testing.

(green)

C Button

Codes the meter, changes meter settings, scrolls through memory.

Power Button

Turns meter on and off.

Contact Points

Sense position and orientation of test strip.

Lens Area

Contains the optics that reads glucose level. Test strip holder covers lens area.

(blue)

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)

Blood Glucose Meter

Toll-free customer service:

UNITED

1 800 524-7226

STATES:

CANADA:

1 888 353-0800

Milpitas, California 95035 C22.2 No. 125; Risk Class 2

Battery Compartment

Holds two AAA alkaline batteries.

Introduction

Display Symbols

The SureStep Meter uses symbols to guide you through a test and inform you if it detects a problem with the test strip or meter. A display of all symbols appears briefly each time you turn on the meter. To check that all display symbols are working, press and hold down the blue power button.

◆ IMPORTANT

Carefully check that all symbols and symbol segments shown below appear each time you turn on the meter. If any segments are missing, call the LifeScan Healthcare Professional Line at 1 800 524-7226.

Chapter 1

Meter Memory Result

The meter stores up to 10 blood glucose and control solution test results in memory. When you turn on the meter, the last (most recent) result is automatically displayed (if this option is selected).

(Example)

Code Number

The number on the meter display must match the code number on the SureStepPro Test Strip bottle. Check the code number before every test. Change the code number if it does not match the number on the test strip bottle.

(Example)

Introduction

Apply Blood Sample to the Test Strip

This symbol prompts you to apply sample to the center of the pink test square.

Insert Test Strip All the Way Into the Meter

This symbol prompts you to firmly insert the test strip all the way into the test strip holder. Firmly push the test strip until it stops.

▲ CAUTION

If you fail to completely insert the test strip, the test may start; however, you may receive an inaccurate, low result.

Chapter 1

Meter is Reading the Result

The test result appears in approximately 30 seconds. The time may vary depending on temperature and glucose level.

Test Result

The meter displays results between 0–500 mg/dL (0–27.8 mmol/L).

(Example)

Introduction

HI Result

The meter reads HI in virtually all cases when a result is greater than 500 mg/dL (27.8 mmol/L).

◆ IMPORTANT

When the result is greater than 500 mg/dL and proper procedures are followed, the meter will display HI in virtually all cases. The confirmation dot will also be darker than the 350-mg/dL sample color dot on the test strip bottle Color Chart. This indicates hyperglycemia. Follow your institution’s policies for treatment.

Chapter 1

Error Messages

When the meter detects a problem it displays a specific error message (Er1 through Er6). Refer to Chapter 5 for more information on error messages.

(Example)

Remove the Test Strip

This symbol indicates that the test strip may have been inserted incorrectly or too quickly. See Chapter 5 for more information.

Introduction

Replace the Two AAA Alkaline Batteries

When this symbol appears, the batteries are low and should be replaced as soon as possible. When the symbol is flashing, the batteries are dead and should be replaced immediately.

SureStepPro Test Strips

SureStepPro Test Strips should be used with the SureStep Hospital System.

When blood is applied to the pink test square, a chemical reaction takes place. A blue color forms in the confirmation dot on the back of the test strip. If the confirmation dot is completely blue, this indicates that an adequate volume of sample was applied. The

Chapter 1

intensity of the blue is read by the meter—the darker the blue, the higher the blood glucose level.

FRONT

white pad

White Tip

white tip

pink test square

faces up as the test strip is

BACK

black tip

confirmation dot

inserted into the test strip holder.

Pink Test Square

is where you apply the blood. For detailed information, refer to step 4 on page 32.

White Pad

absorbs any 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 the meter

determine when the strip has been inserted.

Introduction

Confirmation Dot

is read by the meter to determine the sample’s glucose concentration. If it turns completely blue, this indicates an adequate volume of blood was applied.

◆ IMPORTANT Test Strip Information

For detailed information regarding SureStepPro Test Strips, read the package insert.

• Use only SureStepPro Test Strips with the

SureStep Hospital Meter.

• SureStepPro Test Strips are sensitive to

heat, light, and moisture. Keep them tightly sealed in their original bottle and store in a cool, dry place below 30 °C (86°F). Do not refrigerate, freeze, or place in direct heat or sunlight.

• Do not use test strips after the expiration

date printed on the bottle label.

• Discard any unused test strips 4 months

after opening. Write the opened date on the bottle when you first open it.

Chapter 1

• Replace the test strip bottle cap immediately after removing a test strip and close the cap tightly.

• Do not use test strips that are bent, torn, cut, or damaged in any way.

• Use each test strip immediately after removing it from the bottle.

• Do not transfer test strips to a new bottle or any other container.

• Compare the color of the test strip confirmation dot to the “Unused” color dot shown on the Color Chart on the test strip bottle label. If the color of the test strip confirmation dot is darker than that shown on the Color Chart, do not use the test strip. The result may be inaccurate.

• You have up to 2 minutes to insert the test strip into the meter 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.

Introduction

Precautions

• Unexpected results should be confirmed by a laboratory test.

• Various conditions may cause the meter to produce a very low test result (20 mg/dL [1.0 mmol/L] or less).

• If the patient has symptoms of low

blood glucose, follow your institution’s policy for treatment.

• If the patient does not have symptoms

of low blood glucose, check the confirmation dot on the back of the test strip.

– If the confirmation dot has white patches or streaks, repeat the test with a new test strip.

– 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 indicates very low blood glucose, repeat the test. If the result is still lower than expected,

Chapter 1

perform a quality control test. A passing control result indicates the system is working properly. A control result that is out of range indicates that the system may not be working properly. Do not use

the system to test patient blood glucose unless the control solution result falls within the expected 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 with a laboratory test.

• If you repeatedly get any error message, obtain a result from a laboratory test. Compare the test strip confirmation dot to the colors on the test strip bottle Color Chart, and if necessary, take appropriate precautions while awaiting the lab result.

Do not use the Color Chart as a replacement for a meter result.

Introduction

• Never make significant changes to a medication program or ignore signs and symptoms without consulting a physician.

• Failure to follow the instructions for use may result in inaccurate results.

Infection Control

Use universal blood precautions.* All patient samples and materials with which they come in contact 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.

* Centers for Disease Control Report. Guideline for Infection Control in Health Care Personnel. Am J Infect Control. 1998;26:289–354.

Chapter 1

CHAPTER 2

Operation

Coding the Meter

The SureStep Meter is calibrated at the factory. Although an internal verification is performed each time the meter is turned on, a system calibration (meter and test strip) is necessary. This is achieved at the start of each test when you enter the code number for the current bottle of test strips.

Each time you test or when you open a new bottle of test strips, check that the code number on the meter matches the code number on the test strip bottle. If the meter code does not match the code on the test strip bottle, change the meter code.

Operation

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