Lifescan SureStep Blood Glucose Monitor Manual

®
company
a
Hospital Meter Operator’s Guide
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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.
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©2002, 1997 LifeScan, Inc. All rights reserved.
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.
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iii
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
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iv
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
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v
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 blood-
borne pathogens between patients, while
providing accurate and reliable blood
glucose results at the point of care.
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vi
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.
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vii
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.
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viii
Help
1Read through the section of the guide
specific to the operation you are performing.
Refer to the table of contents or index to
locate information.
2See Chapter 5 for troubleshooting
information.
3Call LifeScan Customer Service toll free at:
1 800 524-7226 (USA) or
1 888 353-0800 (Canada).
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Introduction 1
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
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Introduction
2Chapter 1
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
C Button (green)
Codes the meter,
changes meter
settings, scrolls
through memory.
Power Button (blue)
Turns meter on and off.
Lens Area
Contains the optics
that reads glucose
level. Test strip holder
covers lens area.
Display
Shows test results and
symbols that guide
you through testing.
Contact Points
Sense position and
orientation of test strip.
FRONT
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Introduction 3
BACK
OPENED
Blood Glucose Meter
1 800 524-7226
1 888 353-0800
Milpitas, California 95035
C22.2 No.125; Risk Class 2
© LifeScan Inc.1999 B1
R
Toll-free customer service:
UNITED
STATES:
CANADA:
Insertion
Point
Test Strip Holder
Protects the lens and
holds the test strip. The
insertion point is where
the test strip is inserted.
CLOSED
Cover
Base
Meter Serial
Number
(Example)
Battery
Compartment
Holds two AAA
alkaline batteries.
■NOTE
The test strip holder is interchangeable—the
same holder can be used in any SureStep brand
meter.
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Introduction
4Chapter 1
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.
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Introduction 5
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).
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)
(Example)
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Introduction
6Chapter 1
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.
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Introduction 7
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)
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Introduction
8Chapter 1
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.
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Introduction 9
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.
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.
(Example)
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Introduction
10 Chapter 1
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
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