Lifescan SureStep Pro Manual

Bedside Unit Operator’s Guide
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The SureStep®Pro Bedside Unit 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.
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▲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 SureStepTest 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.
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Table of Contents
Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . v
About This Guide . . . . . . . . . . . . . . . . . . . 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
System Beep Signals . . . . . . . . . . . . . . . . . 9
SureStepPro Test Strips . . . . . . . . . . . . . . . . 9
Precautions . . . . . . . . . . . . . . . . . . . . . . . . 12
Infection Control . . . . . . . . . . . . . . . . . . 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–Patient Test . . . . . . . . . . . . . 29
Performing a Patient Test . . . . . . . . . . . . . 29
Applying Blood Sample to Test Strip . . . 33
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Table of Contents
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CHAPTER 4–Data Management . . . . . . . 41
Transferring Data to the Workstation . . . . 41
Using a Direct Infrared Port Connection 42
Using the Connection Module. . . . . . . . 44
Bedside Unit Memory . . . . . . . . . . . . . . . . 49
Accessing Memory to Review Data . . . . 49
CHAPTER 5–Care and Maintenance . . . . 53
General Care . . . . . . . . . . . . . . . . . . . . . . . 53
When to Clean 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
Linearity Test . . . . . . . . . . . . . . . . . . . . . . 61
Unknown Solution Test . . . . . . . . . . . . . . 69
In-Service Test . . . . . . . . . . . . . . . . . . . . . 75
CHAPTER 7–Troubleshooting . . . . . . . . 77
Error Messages . . . . . . . . . . . . . . . . . . . . . 79
Unexpected Messages and Observations . . 85
APPENDIX A–Bedside Unit
Configuration Options . . . . . . . . . . . . . 91
Specifications . . . . . . . . . . . . . . . . . . . . . 97
Bedside Unit Specifications . . . . . . . . . . . . 97
Barcode Specifications . . . . . . . . . . . . . . . . 98
Cleaning Agents . . . . . . . . . . . . . . . . . . . 100
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . 101
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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.
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Preface
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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.
Chapter 4, Data Management, covers the
bedside unit/workstation data transfer session.
Details for this procedure can be found in the
DataLink System Administrator’s Guide. Chapter
4 also provides information on reviewing test
results stored in bedside unit memory.
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Chapter 5, Care and Maintenance, instructs
you on how to clean the bedside unit and test
strip holder and change the batteries.
Chapter 6, Special Tests, provides instructions
for performing a linearity test and an unknown
solution test. Also included are instructions on
in-service training, when teaching new
operators how to use the bedside unit to
perform a glucose test.
Chapter 7, Troubleshooting, lists error
conditions that may occur or messages that
may appear during operation and offers
solutions to correct the problems.
Appendix A, Bedside Unit Configuration
Options, includes a list of all bedside unit
options that have been configured (selected by
your system administrator) at the workstation.
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Preface
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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.
Text within shaded boxes appears throughout
this guide. This information describes a
specific workstation option and how it may
affect bedside unit operation.
For example:
Enter your operator ID.
For a list of workstation options that are
reflected in the bedside unit, refer to
Appendix A, Bedside Unit Configuration
Options.
Depending on the configuration option setting,
you may or may not be required to enter your
operator ID.
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