Lifescan SureStepFlexx Manual

The SureStep®Flexx Meter is for in vitro diagnostic use

for the quantitative measurement of glucose

in venous, capillary, arterial, and neonatal

whole blood samples. It should not be used

for the diagnosis of diabetes.

Stealth.book Page i Monday, October 28, 2002 11:20 PM

This meter may contain a barcode scanner. The label on

the back of the meter indicates if a scanner is installed.

If the meter does not contain a barcode scanner, you

may add one. The scanner will be shipped with a new

battery compartment door that has the appropriate

barcode scanner label. For meters equipped with a

barcode scanner, the following precaution applies:

▲CAUTION: This product contains a barcode scanner.

It is a class II laser which operates at 640–690 nm

and emits 0.2 mW of energy. This product meets 21

CFR (Code of Federal Regulations) 1040.10* and

1040.11* laser light when activated.

Do not stare into the laser beam. Refer to page 10 for

instructions on barcode scanner operation.

The system described herein is covered by one or more of the following US

patents: D444,235, 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 the 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.

*Food and Drug Administration (FDA) regulations established

for any product that contains a laser.

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iii

Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vii

About This Guide . . . . . . . . . . . . . . . . . . . . . . . . . viii

What You’ll Find in This Guide . . . . . . . . . . . viii

Conventions Used in This Guide . . . . . . . . . . . . ix

Help . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . x

Chapter 1: Introduction. . . . . . . . . . . . . . . . . . . 1

Meter Configuration . . . . . . . . . . . . . . . . . . . . . . . . . 2

Meter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Test Strip Holder . . . . . . . . . . . . . . . . . . . . . . . . . 5

General Operating Information . . . . . . . . . . . . . . . . . 6

Status Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Main Menu and Quick Keys. . . . . . . . . . . . . . . . . 8

Entering Information . . . . . . . . . . . . . . . . . . . . . . 8

Scanning a Barcode . . . . . . . . . . . . . . . . . . . . . . 10

System Beep Signals. . . . . . . . . . . . . . . . . . . . . . 11

SureStepPro Test Strips . . . . . . . . . . . . . . . . . . . . . . 12

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

Infection Control . . . . . . . . . . . . . . . . . . . . . . . . 15

Chapter 2: Quality Control Test . . . . . . . . . . . 17

When to Perform a Quality Control Test. . . . . . . . . 19

Glucose Control Solutions . . . . . . . . . . . . . . . . . . . . 20

Performing a Quality Control Test . . . . . . . . . . . . . 21

Setting Up the Meter . . . . . . . . . . . . . . . . . . . . . 21

Applying Control Solution to the Test Strip. . . . 25

Inserting the Test Strip . . . . . . . . . . . . . . . . . . . 26

Control Solution Results . . . . . . . . . . . . . . . . . . 27

Contents

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Chapter 3: Patient Test . . . . . . . . . . . . . . . . . . 29

Performing a Patient Test . . . . . . . . . . . . . . . . . . . . 30

Setting Up the Meter . . . . . . . . . . . . . . . . . . . . . 30

Applying Blood Sample to the Test Strip . . . . . . 33

Inserting the Test Strip . . . . . . . . . . . . . . . . . . . 36

Patient Results. . . . . . . . . . . . . . . . . . . . . . . . . . 36

Chapter 4: Data Transfer and Management. . 39

Transferring Data . . . . . . . . . . . . . . . . . . . . . . . . . . 40

Using a Connection Module. . . . . . . . . . . . . . . . 40

Using a Serial Cable . . . . . . . . . . . . . . . . . . . . . . 43

Entering a Receiving Modem Phone Number . . 44

Meter Memory. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

Reviewing Data . . . . . . . . . . . . . . . . . . . . . . . . . 45

Chapter 5: Special Tests . . . . . . . . . . . . . . . . . 49

Linearity Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50

Unknown Solution Test. . . . . . . . . . . . . . . . . . . . . . 56

In-Service Test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61

Chapter 6: Care and Maintenance . . . . . . . . . . 63

General Care . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64

Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64

When to Clean the Meter. . . . . . . . . . . . . . . . . . 64

Cleaning the Outside of the Meter . . . . . . . . . . . 64

Cleaning the Test Strip Holder and Lens . . . . . . 65

Changing the Batteries . . . . . . . . . . . . . . . . . . . . . . 68

Adjusting the Screen Contrast . . . . . . . . . . . . . . . . . 70

Setting the Date and Time . . . . . . . . . . . . . . . . . . . 71

Changing the Receiving Modem Phone Number. . . 72

Installing a Barcode Scanner . . . . . . . . . . . . . . . . . . 73

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Chapter 7: Troubleshooting . . . . . . . . . . . . . . 77

Error Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79

Unexpected Messages and Observations. . . . . . . . . . 84

Appendix A: Meter Configuration Options . . 91

Patient Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91

Meter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92

Operator and IDs. . . . . . . . . . . . . . . . . . . . . . . . . . . 93

Quality Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94

Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . 97

Meter Specifications. . . . . . . . . . . . . . . . . . . . . . . . . 97

Barcode Specifications . . . . . . . . . . . . . . . . . . . . . . . 98

Cleaning Agents . . . . . . . . . . . . . . . . . . . . . . . . . . 100

Index. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101

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Stealth.book Page vi Monday, October 28, 2002 11:20 PM

Preface vii

Preface

SureStepFlexx Professional Blood Glucose

Management System is LifeScan’s integrated system

for testing, tracking, and managing patient and

quality control data.

The SureStepFlexx 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.

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viii SureStepFlexx Meter Operator’s Guide

About This Guide

The SureStepFlexx Meter Operator’s Guide provides

detailed instructions on using and maintaining the

SureStepFlexx Meter. Because meter settings may vary

depending on how the meter 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, Meter Configuration Options,

for a list of default stand-alone meter options, as well

as options configured at a workstation.

What You’ll Find in This Guide

Chapter 1, Introduction, provides you with an

overview of the system and outlines basic meter

operating instructions.

Chapter 2, Quality Control Test, guides you through

the steps to perform a quality control test.

Chapter 3, Patient Test, guides you through the steps

to perform a patient blood test.

Chapter 4, Data Transfer and Management, covers the

transfer of data between the meters and the

workstation. It also provides information on reviewing

test results stored in meter memory.

Chapter 5, Special Tests, provides instructions for

performing a linearity test, an unknown solution test,

and an in-service test.

Chapter 6, Care and Maintenance, instructs you on

how to clean the meter and test strip holder, change

the batteries, and install a barcode scanner.

Stealth.book Page viii Monday, October 28, 2002 11:20 PM

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