Bedside Unit Operator’s Guide
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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.
ii
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Table of Contents
What You’ll Find in This Guide. . . . . . . vi
Conventions Used in This Guide . . . . . . . viii
The Bedside Unit . . . . . . . . . . . . . . . . . . . . . 3
General Operating Information . . . . . . . . . . 5
Entering Information . . . . . . . . . . . . . . . . 6
System Beep Signals . . . . . . . . . . . . . . . . . 9
SureStepPro Test Strips . . . . . . . . . . . . . . . . 9
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
iii
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Table of Contents
CHAPTER 4–Data Management . . . . . . . 41
Accessing Memory to Review Data . . . . 49
CHAPTER 5–Care and Maintenance . . . . 53
General Care . . . . . . . . . . . . . . . . . . . . . . . 53
When to Clean the Unit . . . . . . . . . . . . 53
CHAPTER 6–Special Tests . . . . . . . . . . . . 61
Linearity Test . . . . . . . . . . . . . . . . . . . . . . 61
Unknown Solution Test . . . . . . . . . . . . . . 69
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
iv
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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.
v
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Preface
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.
vi
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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.
vii
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Preface
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:
1
Enter your operator ID.
Depending on the configuration option setting,
you may or may not be required to 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.
viii
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Help
1. Read through the section of the guide
specific to the operation you are performing.
Refer to the table of contents and index to
locate information.
2. See Chapter 7 for error messages and
troubleshooting information.
3. Call LifeScan Healthcare Professional Line at:
1 800 524-7226 (USA)
1 888 353-0800 (Canada)
ix
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CHAPTER 1
Introduction
The SureStepPro Bedside Unit is one
component of LifeScan’s professional blood
glucose monitoring system. When used with
SureStepPro Test Strips, the bedside unit
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 bedside unit. A confir-
mation dot on the test strip helps you check
that an adequate volume of sample was applied.
The unit is equipped with a barcode scanner
and a large touch-sensitive display, both of
which allow you to enter operator, patient, and
reagent information.
Before use, each bedside unit must be
configured by your institution’s system
administrator. Your administrator has defined a
set of options from a central workstation
running DataLink™ Data Management System
software (or compatible data management
software). This configuration process provides
the flexibility to customize a blood glucose
testing protocol that meets the needs of your
institution.
1
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Introduction
The bedside unit stores patient and quality
control data in internal memory. A bi-directional
data transfer, performed with the workstation,
sends test results from the bedside unit to the
workstation and the latest configuration infor-
mation from the workstation to the bedside unit.
LifeScan’s DataLink System for modems or
network provides you with choices for connec-
tivity solutions. Following a data transfer session,
reports can be generated and printed from the
workstation.
The complete SureStepPro Professional Care
Blood Glucose Management System includes a
computer workstation and software, bedside
units, test strips, glucose control solutions,
glucose linearity kit, and carrying case.
*
*Computer products may vary from those shown.
For important information on any of these
LifeScan products, refer to the appropriate
operator’s guide or reagent package insert. It is
important that you read and understand all
instructions before you operate the system.
2
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The Bedside Unit
FRONT
Power button turns
the unit on and off.
Test strip holder
covers the lens area and
holds the test strip. The
holder slides out of the
unit for easy cleaning.
The lens area, located
under the test strip
holder, contains the
optics that reads the
glucose level on the
test strip.
Contact points, under
the test strip holder,
sense the position and
orientation of the test
strip.
LCD screen displays
test results and prompts
that guide you through
QC and patient testing.
The touch-sensitive
screen allows you to
select options and enter
information by simply
touching an area of the
screen.
Barcode scanner enables
direct data entry for operator ID,
patient ID, and control solution
and test strip lot numbers from
their respective barcodes.
Infrared communication port
communicates with the
workstation, via the connection
module.
▲ CAUTION
Do not stare into the barcode scanner or point it
towards anyone’s eyes while the laser light is on.
3
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Introduction
TEST STRIP HOLDER
The test strip holder is interchangeable—the
same holder may be used in any SureStep brand
meter.
Closed
The insertion point is the area
where the test strip is inserted.
Opened
The base holds the test
strip in place.
The cover protects the lens.
BACK
Battery Compartment holds
two size C alkaline batteries.
4
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General Operating Information
LifeScan recommends that only certified
operators in the hospital or clinic perform
blood glucose testing using the SureStepPro
System.
Before you can operate the bedside unit, it must
be configured. Your system administrator will
perform this function after completing the
initial system setup.
The configuration of a bedside unit and how it
operates is determined by choices the system
administrator makes within DataLink Data
Management software running at the
workstation. It may be helpful for you to
familiarize yourself with the exact
configuration for the bedside unit you are
operating. This will prepare you for what to
expect when performing QC and patient tests.
You may request a Location (or Nursing Unit)
Configuration Report from your system
administrator. This report lists each option
that was selected for all bedside units within a
selected nursing unit.
5
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Introduction
A Main Menu lets you select from six different
functions.
Patient Test allows you to run a
patient test.
QC Test allows you to run a quality
control test.
Transfer Data transfers data
between bedside unit and workstation.
Review Data displays stored test
results and reagent lot numbers.
Special Tests allows you to run
linearity and unknown test solutions
and perform in-service testing.
Setup allows you to adjust the
bedside unit’s LCD contrast.
Last Upload displays the date and time of the
last successful data transfer session (SureStepPro
2.0 only).
Entering Information
Select an item from a list by touching the
appropriate area of the screen. If a list is too
long to fit on one screen, arrow buttons allow
you to scroll through the list.
6
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Manually enter IDs or lot numbers by pressing
the appropriate characters on the screen. Both
alpha and numeric characters are available for
data entry. Use the A–Z and 0–9 buttons to
switch between alpha and numeric modes.
Press Ok when you have completed the entry.
To delete the last character or characters
entered, press Del.
▲ NOTE
If left inactive, the bedside unit will
automatically shut off. Press the power button
to turn it back on. If you entered your operator
ID before the unit was turned off, it can remain
in memory for up to 1 hour.
A configuration option may be set to maintain
your ID for up to 1 hour after the bedside unit
is turned off.
7
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Introduction
Scanning a Barcode
The bedside unit’s barcode scanner must be
enabled at the workstation. If the scanner is
enabled, the Scanner field at the Status screen
reads ON when you turn on the unit, and the
Scan button appears on data entry screens. If the
scanner is not enabled, the field reads OFF and
the Scan button does not appear on the screens.
To scan a barcode, hold the barcode label
parallel to and approximately 6 to 10 inches
from the unit’s scanner. Press and release the
Scan button on the screen. Scanning begins
when your thumb is lifted from the screen.
After a successful scan, the information appears
in the display field and the bedside unit beeps.
Press Ok to confirm the entry.
Press
Release
▲ CAUTION
This product contains a laser. Do not stare into
the laser light or point it towards anyone’s eyes
while scanning a barcode.
8
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System Beep Signals
The SureStepPro Bedside Unit uses beeping
signals to indicate various stages in the testing
procedure. These signals do not indicate that
the procedure is being performed correctly.
The unit can detect some, but not all, errors in
the test procedure.
• A single short beep sounds each time a
selection is made or a button is pressed on
the screen.
• Three short beeps sound when a test result is
displayed.
• A single, long beep accompanies error
messages and errors that are detected in the
test procedure, as well as CRITICAL HIGH,
CRITICAL LOW, and HIGH results. This
beep is also used at various times during the
test strip insertion stages of the test.
A configuration option may be set to turn Off
most beeps except error beeps and the touch
screen feedback beep.
SureStepPro Test Strips
SureStepPro Test Strips are the only test strips
specifically designed, developed, and tested for
use with the SureStepPro Bedside Unit.
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
9
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Introduction
sample was applied. The intensity of the blue is
read by the bedside unit—the darker the blue,
the higher the glucose level.
BACK
FRONT
black tip
white tip
pink test square
confirmation dot
white pad
White Tip faces up as the test strip is inserted
into the test strip holder.
Pink Test Square is the area where the blood
must be applied. For detailed information,
refer to “Applying Blood Sample to Test Strip”
on page33.
White Pad absorbs 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 unit
determine when the strip has been inserted.
Confirmation Dot is read by the bedside unit
to determine the sample’s glucose concentration.
If it turns completely blue, this indicates that an
adequate volume of blood was applied.
10
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▲ IMPORTANT Test Strip Information
For detailed information regarding
SureStepPro Test Strips, read the package
insert.
• Use only SureStepProTest Strips with the
SureStepPro Blood Glucose Bedside Unit.
• 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.
• A lot number and CTL (control) code are
printed on the test strip bottle label. (The
CTL code encodes the test strip expiration
date, control solution ranges, and linearity
reference values.) When entering this
information, always get the lot number and
CTL code from the test strips currently in use.
• Do not use the 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.
• Replace the test strip bottle cap immediately
after removing a test strip and close the cap
tightly.
• Do not transfer test strips to a new bottle or
any other container.
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Introduction
• Use each test strip immediately after
removing it from the bottle.
• Do not use test strips that are bent, torn, cut,
or damaged in any way.
• Compare the color of the confirmation dot
from an unused test strip 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 test result may be inaccurate.
• You have up to 2 minutes to insert the test
strip 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.
Precautions
• Unexpected results should be confirmed by a
laboratory test.
• Various conditions may cause the bedside
unit 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.
12
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– 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, 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 laboratory
result. Do not use the Color Chart as a
replacement for a bedside unit result.
• 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.
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Introduction
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.
14
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CHAPTER 2
Quality Control Test
Three levels of SureStepPro Glucose Control
Solution are available to check that the
SureStepPro Bedside Unit and SureStepPro
Test Strips are functioning properly.
The SureStepPro bedside units are calibrated at
the factory. Although an internal verification is
performed each time the bedside unit is turned
on, a system calibration (bedside unit and test
of each test when you enter the lot number and
code for the current bottle of test strips.
If you are training a new operator on how to
use the bedside unit, use the glucose control
solutions and perform the testing in the
In-Service mode. Refer to “In-Service Test” on
page 75, for more information.
The number of control levels and frequency of
running a QC test have been programmed by your
system administrator. High, Low, and Normal
control levels are available—any one control level
or a combination of levels may have been selected.
15
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Quality Control Test
To ensure that a required QC test is performed at
the designated time, a warning or lockout mode
was selected. Both modes display a message
informing you that QC is due. The warning mode
allows you to continue with a patient test; the
lockout mode prevents you from using the bedside
unit for a patient test until QC is successfully
performed.
A second lockout mode prevents the operator who
has not performed QC testing within the
designated number of days from using the bedside
unit to test patient blood.
If a lockout mode was selected and QC is due, a
message appears when you start the bedside unit.
You cannot proceed with patient testing until the
required QC tests have been successfully
performed.
When to Perform a Quality Control Test
• As required by your institution’s quality
control policy or local regulatory requirements.
• When you open a new bottle of test strips.
• If a patient test has been repeated and the
blood glucose results are still lower or higher
than expected.
• After cleaning the bedside unit.
• If there are other indications that the system
is not working properly.
• If you drop the bedside unit.
16
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Glucose Control Solutions
Use SureStepPro Glucose Control Solutions
with the SureStepPro Bedside Unit and
SureStepPro Test Strips only.
▲ IMPORTANT Control Solution Information
Read the SureStepPro Control Solutions
package insert for more information.
• Gently shake each vial of control solution
before use.
• Do not use a control solution after the
expiration date printed on the vial label.
• Discard any unused portion 3 months after
opening. Write the opened date on the vial
when you first open it.
• The control ranges printed on the
SureStepPro Test Strip bottle label are for
SureStepPro Control Solutions only.
• Store the control solution at room
temperature below 30°C (86°F). Do not
refrigerate or freeze.
• The control solutions contain dye that
stains clothing.
• The control solutions are not for human
consumption.
• Control solution values can be affected at
altitudes of 3000 feet or greater. Read the
SureStepPro Glucose Control Solutions
package insert for specific information and
correction factors.
17
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Quality Control Test
Performing a Quality Control Test
1
Press the power button to turn on the unit.
A start-up screen appears...
...followed by the Status screen.
2
Check the battery status to ensure adequate
power. The battery and memory bars provide
the approximate status of battery power and
bedside unit memory. (If there is insufficient
battery power or memory to perform a test, a
warning message appears.) Press Cont. to
continue.
18
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3
Select QC Test from the
Main Menu.
4
Enter your operator ID,
either by pressing the
touch screen or using the
barcode scanner. Refer to
page 8 for information on
scanning a barcode.
Depending on the configuration option setting,
you may or may not be required to enter your
operator ID.
If your operator ID is required, a configuration
option may be set to remember your ID for up to
1 hour after the bedside unit is turned off. If
your ID appears at the operator ID screen, press
Ok to confirm it is correct. If the ID is not
correct, simply enter your ID and it will replace
the existing ID.
19
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Quality Control Test
5
Select the control level you
wish to run; for example,
High.
Select QC Test
High
(req.d)
(req.d)
(req.d)
Low
Normal
Menu
The control level(s) you are required to run have
been selected by your system administrator. They
are labeled req.d (required) at the Select QCTest
screen.
6
Select the control lot
number from the list
displayed. The last control
lot selected appears at the
top of the list. Use the
arrows to scroll through the
list, if necessary.
Alternatively, scan the
barcode on the control vial.
Depending on the configuration option setting,
you may or may not be required to enter the
control lot number. If you are not required to
enter the control lot number, the Select Lot #
screen will not appear.
20
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If you are required to enter the control lot
number, a configuration option may have been
selected which will allow you to enter a new
control solution lot number at the bedside unit.
If you do not see the lot number in the list and
the Enter Control Lot # button appears on the
screen, press the button and manually enter the
control solution lot number and expiration date.
7
Select the test strip lot
number (and code) from the
list displayed. The last test
strip lot number selected
appears at the top of the list.
Use the arrows to scroll
through the list, if necessary.
Alternatively, scan the
barcode on the test strip
bottle label.
A configuration option may have been selected
which would allow you to enter a new test strip
lot number at the bedside unit. If you do not see
the lot number in the list and the Enter Strip Lot
button appears on the screen, press the button
and manually enter the test strip lot number and
CTL code.
▲ CAUTION
To obtain accurate results, you must enter the
correct test strip lot number (and code) for each
new test.
21
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Quality Control Test
The QC Test screen appears with messages
prompting you to apply the control to the test
strip and then insert the test strip.
Applying Control Solution to Test Strip
▲ CAUTION
Applying too much or too little control
solution may cause out-of-range results.
8
Apply the control solution as follows:
• Gently shake the control solution vial.
• Touch a drop of control solution to the center
of the pink test square.
22
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If the white pad becomes completely saturated,
you have applied too much control solution.
Repeat the application with a new test strip.
• Check the confirmation dot on the back of
the test strip to verify it has turned
completely blue, indicating an adequate
amount of control was applied.
If white patches or streaks are visible, you have
not applied enough control solution. Repeat
the application with a new test strip.
• Wipe the control solution vial tip with a
lint-free cloth or tissue before replacing the
cap.
9
Firmly insert the test strip all the way into the
test strip holder until it stops (the
confirmation dot should be facing down).
23
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Quality Control Test
▲ IMPORTANT
If you fail to completely insert the test strip,
the test may start; however, you may receive an
out-of-range result.
▲ IMPORTANT
You have up to 2 minutes to insert the test
strip after the control solution is applied. If
you insert the test strip after 2 minutes, you
may get an out-of-range result or an error
message. Discard the test strip and repeat the
test with a new test strip.
10 The QC test result appears in approximately
30 seconds. The time may vary depending on
the temperature and glucose level.
24
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▲ IMPORTANT
Do not remove the test strip until the
countdown is complete.
Depending on the configuration option setting,
the QC result will be displayed as either a
numeric value or Passed/Failed.
• If the result is PASSED,
press Ok, remove the strip,
and continue with the
remaining required control
levels.
Or, if you wish to record
additional information
with the test result, press
Enter Notes and choose
1 to 3 comments from the
list. Press Ok and remove
the test strip.
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Quality Control Test
• If the result is FAILED,
press Enter Notes and
choose from 1 to 3
comments. This will be
recorded with the failed
result. Press Ok, remove
the test strip, and repeat
the QC test.
Or, if the Menu button is
displayed at the Failed QC
screen, you may press Menu
to repeat the test without recording any
comments with the test result.
Read the SureStepPro Test Strip package
insert for information on troubleshooting a
failed QC test.
▲ CAUTION
If the control solution result fails, repeat the
test. The system may not be functioning
properly. Do not use the system to test a
patient’s blood glucose level unless the control
solution result falls within the expected range.
A configuration option was selected which may
require you to select comments when a QC test
fails. If Enter Notes is the only option available
at the failed QC Result screen, you are required
to select at least one comment.
The comments that appear at the Select Comment
screen have been selected by your system
administrator.
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▲ NOTE
Results tagged with the comment
“Procedure Err” are not included in the
statistical calculations for any QC reports
generated by the system administrator.
If you have problems using the bedside unit to
test the control solutions, or if the bedside unit
malfunctions, call the LifeScan Healthcare
Professional Line at 1 800 524-7226.
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CHAPTER 3
Patient Test
LifeScan recommends that only certified
operators perform patient blood glucose
testing using the SureStepPro System.
Follow your institution’s policies for in-service
training to become a certified operator.
Performing a Patient Test
1
Press the power button to turn on the unit.
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Patient Test
A start-up screen appears...
...followed by the Status screen.
2
Check the battery status to ensure adequate
power. The battery and memory bars provide
the approximate status of battery power and
bedside unit memory. (If there is insufficient
battery power or memory to perform a test, a
warning message appears.) Press Cont. to
continue.
3
Select Patient Test from the
Main Menu.
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4
Enter your operator ID either
by pressing the touch screen
or using the barcode scanner.
Refer to page 8 for
information on scanning a
barcode.
Depending on the configuration option setting,
you may or may not be required to enter your
operator ID.
If your operator ID is required, a configuration
option may be set to remember your ID for up to
1 hour after the bedside unit is turned off. If
your ID appears at the operator ID screen, press
Ok to confirm it is correct. If the ID is not
correct, simply enter your ID and it will replace
the existing ID.
5
Enter the patient’s ID, either
by pressing the touch screen
or using the barcode scanner.
▲ NOTE
Carefully enter the ID. An
accurate patient ID is
imperative for transferring
the correct results to the
medical record.
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Patient Test
Depending on the configuration option setting,
you may or may not be required to enter the
patient’s ID.
6
Select the test strip lot
number (and code) from the
list displayed. The last test
strip lot number selected
appears at the top of the list.
Use the arrows to scroll
through the list, if necessary.
Alternatively, scan the
barcode on the test strip
bottle label.
A configuration option may have been selected
which would allow you to enter a new test strip
lot number at the bedside unit. If you do not see
the lot number in the list and the Enter Strip Lot
button appears on the screen, press the button
and manually enter the test strip lot number and
CTL code.
▲ CAUTION
To obtain accurate results, you must enter the
correct test strip lot number (and code) for each
new test.
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The Patient Test screen appears with messages
prompting you to apply blood to the strip and
then insert the test strip.
Applying Blood Sample to Test Strip
Obtain a drop of blood. Capillary blood can be
obtained from puncturing the finger or heel
using a lancing device. The puncture site
should be cleaned and thoroughly dried before
obtaining the sample. Follow your institution’s
policy and procedure guidelines for blood
collection.
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Patient Test
7
Apply the blood to the test strip as follows:
Finger Stick
Carefully touch the center of the pink test
square to the drop of blood on the patient’s
finger. The test area will quickly absorb the
blood.
Heel Stick
Carefully touch the center of the pink test
square to the drop of blood on the heel.
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Syringe
Touch the tip of the syringe to the center of the
pink test square. Gently apply pressure to the
plunger. As the blood emerges from the tip of
the syringe, it is absorbed by the test square.
▲ CAUTION
Avoid applying too much blood when using a
syringe or you may get an inaccurate, high
result.
Alternatively, dispense the blood from the
syringe into a test tube, then apply blood to
the test square using a narrow-bore pipette.
Pipette
Touch the drop of blood emerging from the tip
of a narrow-bore pipette to the center of the
pink test square.
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Patient Test
8
Check the white pad on the front of the test
strip and the confirmation dot on the back of
the test strip.
• If the white pad becomes completely
saturated, you have applied too much blood
for an accurate result. Repeat the application
with a new test strip.
FRONT
• The confirmation dot on the back of the test
strip should be completely blue.
confirmation
dot
BACK
FRONT
If white patches or streaks are visible on the
blue confirmation dot, you may not have
applied enough blood for an accurate result.
Repeat the application with a new test strip.
BACK
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▲ CAUTION
Do not apply additional blood to the test strip
or you may get an inaccurate result.
If white patches or streaks continue to appear
after you have repeated the test with a new
test strip and a larger sample volume, call the
LifeScan Healthcare Professional Line at
1 800 524-7226.
9
Firmly insert the test strip all the way into the
test strip holder until it stops (the
confirmation dot should be facing down).
▲ CAUTION
If you fail to completely insert the test strip,
the test may start; however, you may receive an
inaccurate, low result.
▲ CAUTION
You have up to 2 minutes to insert the test
strip after the blood is applied. If you insert the
test strip after 2 minutes, you may get an
inaccurate result or an error message. Discard
the test strip and repeat the test with a new
test strip.
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Patient Test
The test result appears in
approximately 30 seconds.
▲ IMPORTANT
Do not remove the test strip
until the countdown is
complete.
If an error message appears,
refer to Chapter 7,
Troubleshooting, for
information.
A glucose range may have been defined by your
system administrator. Results that fall above or
below the limits of this range appear as follows:
• CRITICAL HIGH
indicates a result above
the range.
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• CRITICAL LOW
indicates a result below
the range.
• HIGH indicates a result
greater than 500 mg/dL.
▲ IMPORTANT
When the result is greater than 500 mg/dL and
proper procedures are followed, the bedside
unit will display HIGH in virtually all cases.
Additionally, the confirmation dot will 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.
10
Remove the test strip and dispose of it
according to you institution’s policies and
procedures.
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Patient Test
11
Press Enter Notes and choose
1 to 3 comments that
correspond to the patient’s
current situation. Press Ok.
Or press Menu and continue
testing.
Ok
Depending on the configuration option setting,
you may be required to select comments when a
patient test result falls outside the limits of the
range. If Enter Notes is the only option available
at the Patient Result screen, you are required to
select at least one comment.
The comments that appear at the Select Comment
screen have been selected by your system
administrator.
▲ NOTE
Results tagged with the comment “Procedure
Err” are not included in any patient reports
generated by the system administrator.
If you have problems using the bedside unit to
test patient samples, or if the bedside unit
malfunctions, call the LifeScan Healthcare
Professional Line at 1 800 524-7226.
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CHAPTER 4
Data Management
Transferring Data to the Workstation
Data transfer is required periodically to
exchange information between the workstation
and the bedside unit. Configuration information
is transferred from the workstation to the
bedside unit, and QC and patient test results are
transferred from the bedside unit to the
workstation.
Your institution will establish a regular
schedule for performing data transfer sessions.
Depending on the configuration option
setting, the bedside unit may be disabled from
testing if a data transfer session is not
performed within a designated number of days.
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Data Management
You may transfer data using:
• a direct infrared link with the workstation’s
infrared port
• a connection module that is directly
connected to the workstation’s serial port
• a connection module that is connected to a
serial server or modem.
Using a Direct Infrared Port Connection
To perform data transfer using a direct link
with the workstation’s infrared port, the
bedside unit must be situated next to the
workstation. DataLink Data Management
System software must be running on the
workstation.
1
Select Transfer Data from
the Main Menu.
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The bedside unit is ready
for the communication
link to be established. If
the bedside unit has been
configured to communicate
directly with the workstation
infrared port, the message at
the right appears.
2
Place the bedside unit’s infrared
communication port approximately 6 to
10 inches (15 to 25 centimeters) from the
workstation’s infrared port.
Data transfer begins immediately. The time to
transfer data depends on the amount of
information being exchanged.
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Data Management
A series of messages are
displayed on the bedside
unit screen indicating the
status of the transfer. When
the transfer is complete, the
bedside unit beeps and a
message appears.
Data Transfer
Data Transfer
Complete
Cont.
Using the Connection Module
The connection module, used with a modem,
provides a remote communication link
between the bedside units and the workstation.
By placing the bedside unit in the connection
module and dialing the workstation modem,
data is transferred through a standard analog
phone line.
▲ NOTE
If a fax machine is sharing the same analog line
as the connection module modem, do not
transfer data while a fax is being sent or received.
▲ NOTE
SureStepPro 2.0 users – If you are transferring
data over an Ethernet network, MeterLink
software must be running on the workstation.
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1
Select Transfer Data from
the Main Menu.
The bedside unit is ready for
the communication link to
be established. A message
appears instructing you to
dock the bedside unit.
Data Transfer
Awaiting Link
Dock the
Bedside Unit
Menu
2
Place the bedside unit in the connection module.
SureStepPro 1.2 Users
Enter the workstation
modem phone number, then
press Dial. (Once the phone
number is entered, it will
Enter Phone #
9236699
remain in the bedside unit
memory. For subsequent
1
4
2
5
3
6
sessions, simply press Dial.)
7
8
0
9
Del
Clear
The modem begins dialing.
If the line is busy, the
Menu Wait Dial
connection module will retry
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Data Management
up to 20 times at 30-second intervals before it
times out.
Messages appear on the
screen indicating the status
of the connection. The
indicator light on the
connection module blinks
during transfer. A message
appears when data transfer is
complete.
3
Remove the bedside unit
from the connection module
and press Cont. to continue.
SureStepPro 2.0 Users
Refer to instructions in the following Ethernet
and Modem sections for details.
Direct connection with workstation connection module
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Connection module connected to serial server or modem
Ethernet
If you are transferring data
over an Ethernet network
using a serial server, the
transfer begins immediately.
A series of messages are
displayed on the bedside
unit screen indicating the
status of the transfer. When
the transfer is complete, the
bedside unit beeps and a
message appears.
Modem
If a modem is detected, the connection module
automatically dials the receiving modem. If
the line is busy, the connection module will
retry up to 20 times at 30-second intervals
before it times out.
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Data Management
If the workstation modem
phone number was not pre-
programmed, enter the
phone number, then press
Dial. If the phone number
appears on the screen, simply
press Dial.
Enter Phone #
9236699
1
4
2
5
3
6
7
8
0
9
Del
Clear
Menu Wait Dial
A series of messages are
displayed on the screen
indicating the status of the
transfer. When the transfer
is complete, the bedside unit
beeps and a message appears.
3
Remove the bedside unit
from the connection module
and press Cont. to continue.
If the bedside unit is off when you remove it
from the connection module, you can check to
see that the transfer was successful by turning
on the bedside unit. If an error occurred during
transfer, the following message appears after
the Status screen:
Last Data Transfer mm/dd/yy hh:mm Failed.
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Bedside Unit Memory
The bedside unit stores up to 2500 QC and
patient test results in its memory. Additionally,
the lot IDs for test strips and control, linearity,
and unknown solutions are also stored in
memory. This information can be accessed by
selecting Review Data from the Main Menu.
When bedside unit memory is low (less than
100 tests available), the message Data Memory
Low appears.
When the bedside unit memory is full, a
message appears informing you that there is no
room for test data.To continue using the
bedside unit for testing, you must perform a
data transfer session to upload the data to the
workstation and free the bedside unit’s memory.
Accessing Memory to Review Data
You may review patient, QC, linearity, and
unknown solution test results. In-Service test
results are not available for review.You may
also review a list of test strip lot numbers and
reagent lot numbers.
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Data Management
1
Press Review Data from
the Main Menu.
2
Select Patient Results, QC/
Lin/Unkn, Test Strip Lots, or
Reagent Lots.
Lin and Unkn refer to Linearity
and Unknown Solutions. For
more information, see Chapter
6, Special Tests.
• If you select Patient
Results, you may specify a
particular patient ID and
see only the results for that
patient, or leave the ID
field blank and see the
results for all patients for
the last 30 days, beginning
with the most recently
performed patient test.
Results for each day are
preceded by a header, which includes the date
and number of test results for that day.Test
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results marked with the Procedure Err
comment will appear as Proc Err.
• If you select QC/Lin/Unkn,
you may enter an operator
ID and see the results for
the QC, linearity, and
unknown tests a particular
operator has run, or leave
the operator ID field blank
and see the results for all
QC, linearity, and
unknown tests for the last
30 days, beginning with
the most recently performed test.
The control solution level (L, N, H) is listed
next to the QC result. An F following the
solution type indicates the result failed.
UA–UE is listed next to unknown solution
results. L1–L5 is listed next to linearity
solution results. Results for each day are
preceded by a header, which includes the date
and the number of test results for that day.
▲ NOTE
Test results appearing as HIGH indicate
patient, QC, and unknown solution results
greater than 500 mg/dL or linearity solution
results greater than 766 mg/dL.
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Data Management
• Select Test Strip Lots to see
all test strip lot numbers
with expiration dates
currently entered in the
system. The last lot
number used appears at
the top of the list.
• Select Reagent Lots to see
all control, linearity, and
unknown solution lot
numbers with expiration
dates currently entered in
the system. The last lot
number used appears at
the top of the list.
The solution type abbreviation is listed next
to the lot number.
Abbreviation
Solution Type
L
Low
N
Normal
H
High
UA–UE
L1–L5
Unknown A–Unknown E
Linearity Solutions 1–5
3
Press Menu to proceed, or turn off the bedside
unit.
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CHAPTER 5
Care and Maintenance
General Care
To keep the bedside unit in good operating
condition, you must keep it clean and handle
it with care.
Follow these simple rules:
• Keep the test strip holder and lens area clean.
• Keep the unit dry and avoid exposing it to
extremes in temperature and humidity.
• Do not take apart the unit.
• If you drop the unit, inspect it for obvious
damage. Perform a quality control test prior
to running a patient blood glucose test.
When to Clean the Unit
• If dirt, blood, or lint is present.
• When an error message appears and the
troubleshooting solution indicates cleaning
the unit.
• As defined by your institution’s infection
control policies.
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Care and Maintenance
Cleaning the Outside of the Unit
Clean the outside of the unit with a cloth
moistened with a 10% bleach solution. Follow
with a cloth moistened with water to remove
residual bleach. Dry the unit thoroughly.
▲ CAUTION
Do not get water inside the unit. Never im-
merse the unit or hold it under running water
because it will damage the unit.
Cleaning the Test Strip Holder and Lens
Clean the test strip holder (cover and base),
lens area, and contact points. Use a 10% bleach
solution followed by water.
▲ CAUTION
Do not use alcohol, glass cleaners, or any
cleansers containing abrasives, phenol, or
ammonia to clean the test strip holder or lens
area because it will damage the parts.
1
Press down on the left side of the test strip
holder (the end closest to the power button).
This releases the holder, allowing you to
slide it from the unit.
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2
Wipe the test strip holder cover and base with
a cotton swab or soft cloth moistened with a
10% bleach solution. Be sure to thoroughly
wipe the area on the inside cover. Clean both
sides of the base. Follow with a swab
moistened with water to remove residual
bleach.
▲ CAUTION
Bleach residue left on the test strip holder may
lead to an error message or an inaccurate, high
result.
3
Dry the test strip holder with a soft cloth or
lint-free tissue. Close the holder and set it aside.
4
Using a cotton swab or soft cloth moistened
with a 10% bleach solution, wipe the lens area
and contact points. Wipe this area even if it does
not appear to be dirty. Use a swab or cloth
moistened with water to remove residual bleach.
Be careful not to scratch the lens area.
contact points
lens area
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Care and Maintenance
5
Dry the lens area gently with a clean, soft, lint-
free cloth or tissue. Remove any lint.
6
Slide the closed test strip holder into the unit.
Push the holder until it clicks into place.
7
8
Turn on the bedside unit. If an error appears,
check to make sure you installed the test strip
holder correctly.
If necessary, wipe the scanner with a soft cloth
moistened with water.
9
Perform a quality control test to verify that the
result is within the expected range.
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Changing the Batteries
The SureStepPro Bedside Unit is powered by two
size C alkaline batteries. Change the batteries
when the LOW BATTERY message appears on
the screen. You may want to change the batteries
if the battery bar on the Status screen is low.
However, the unit will continue to function
properly until the LOW BATTERY message
appears.
▲ CAUTION
Do not use rechargeable batteries.
▲ NOTE
Neither the LOW BATTERY message nor the
removal of batteries affects the test results
stored in the bedside unit’s memory.
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Care and Maintenance
1
Press the power button to turn off the
bedside unit.
2
Turn the unit over. Use a coin or screwdriver to
loosen the screw from the battery compartment
door. Lift open the door.
3
Remove both batteries from the battery
compartment and dispose of them according to
your institution’s guidelines.
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4
Insert two new size C batteries, matching the
positive (+) end of each battery with the +
signs inside the battery compartment.
▲ NOTE
The battery life depends on how quickly the
bedside unit is powered off after each test.
Under optimal conditions—using the barcode
scanner to enter information and turning off
the bedside unit immediately after test results
are displayed and recorded—you can expect
approximately 1000 tests.
5
Replace the battery compartment door and
tighten the screw.
6
Turn on the unit to verify the power.
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Care and Maintenance
Adjusting the Screen Contrast
You can increase or decrease the LCD screen
contrast.
1
Select Setup from the Main
Menu.
2
Press the arrows to increase
or decrease the LCD
contrast. A change occurs
each time you press the
arrow. The gauge in the
Low/High bar gives you an
approximate indication of
the current setting.
3
When you are satisfied with the setting, press
Ok to save the setting and proceed to the Main
Menu. Or, press Menu to ignore any changes
and proceed to the Main Menu.
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CHAPTER 6
Special Tests
The Special Tests function allows you to
perform tests that are not routinely performed,
such as a linearity test and an unknown solution
test. Special Tests also features an In-Service
mode, which allows you to use the bedside unit
for training new operators. Test results obtained
while operating in the In-Service mode are
uploaded to the DataLink workstation and can
be viewed in the Datalog Report generated by
the system administrator.
Linearity Test
A Linearity Solution kit is available from
LifeScan. The kit contains five levels of glucose
solution used to check the linearity of the
system. Linearity solution results can be
affected at altitudes of 2000 feet or greater.
Read the SureStepPro Linearity Test Kit
package insert for information.
Refer to your institution’s policy for
establishing the linearity of a test method.
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Special Tests
1
2
3
Select Special Tests from the
Main Menu.
Select Lin/Unkn Test from
the Special Tests menu.
Enter your operator ID.
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Depending on the configuration option setting,
you may or may not be required to enter your
operator ID.
If your operator ID is required, a configuration
option may be set to remember your ID for up
to 1 hour after the bedside unit is turned off. If
your ID appears at the operator screen, press Ok
to confirm it is correct. If the ID is not correct,
simply enter your ID and it will replace the
existing ID.
4
Start by selecting Lin 1.
5
Select the Linearity Solution
lot number from the list
displayed.
Select Lot
Linearity
#
1
LIN4001
Alternatively, scan the
barcode on the linearity
solution vial.
LIN4002
Enter Lin 1
Lot #
Menu Scan
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Special Tests
Depending on the configuration option setting,
you may be required to enter the linearity
solution lot number. If you are not required to
enter the lot number, the Select Lot # screen
will not appear.
If you are required to enter the linearity
solution lot number, you may be allowed to
enter a new linearity lot number at the bedside
unit. If you do not see the lot number in the list
and the Enter Lin Lot # button appears on the
screen, press the button and manually enter the
linearity solution lot number and expiration
date.
6
Select the test strip lot
number (and code) from the
list displayed. The last test
strip lot number selected
appears at the top of the list.
Use the arrows to scroll
through the list, if necessary.
Alternatively, scan the
barcode on the test strip
bottle label.
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A configuration option may have been selected
which would allow you to enter a new test strip
lot number at the bedside unit. If you do not
see the lot number in the list and the Enter
Strip Lot button appears on the screen, press
the button and manually enter the test strip lot
number and CTL code.
▲ CAUTION
To obtain accurate results, you must enter the
correct test strip lot number (and code) for each
new test.
7
SureStepPro 2.0 users, press
Ok to perform the test for the
linearity level and replicate
indicated.
8
Apply the linearity solution to the test strip.
▲ CAUTION
Applying too much or too little linearity
solution may cause out-of-range results.
• Gently shake the linearity solution vial.
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Special Tests
• Touch a drop of linearity solution to the
center of the pink test square.
If the white pad becomes completely
saturated, you have applied too much
linearity solution. Repeat the application
with a new test strip.
• Check the confirmation dot on the back of
the test strip to verify it has turned
completely blue, indicating an adequate
amount of solution was applied.
If white patches or streaks are visible, you
have not applied enough linearity solution.
Repeat the application with a new test strip.
• Wipe the linearity solution vial tip with a
lint-free cloth or tissue before replacing the
cap.
9
Firmly insert the test strip all the way into the
test strip holder until it stops (the
confirmation dot should be facing down).
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▲ IMPORTANT
If you fail to completely insert the test strip,
the test may start; however, you may receive an
out-of-range result.
▲ IMPORTANT
You have up to 2 minutes to insert the test
strip after the linearity solution is applied. If
you insert the test strip after 2 minutes, you
may get an out-of-range result or an error
message. Discard the test strip and repeat the
test with a new test strip.
The test result appears in
approximately 30 seconds. The
time may vary depending on
the temperature and glucose
level.
▲ IMPORTANT
Do not remove the test strip
until the countdown is
complete.
▲ NOTE
The bedside unit can display linearity results
up to 766 mg/dL.
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Special Tests
If you wish to record additional information
with the test result, press Enter Notes and
choose a comment from the list. Press Ok.
10
SureStepPro 2.0 – Press Ok at
the Linearity Level Result
screen to display the Lin Level
screen. Press Ok to proceed
with the remaining replicates
of level 1.
SureStepPro 1.2 – Press Ok
to display the Lin/Unkn Test
screen. Proceed with the
remaining replicates of level 1.
11
SureStepPro 2.0 users – press Next Level
from the Linearity Level screen to continue
with the remaining linearity solution levels
(2 through 5).
SureStepPro 1.2 users – continue with the
remaining levels.
When the testing of all five levels is complete,
perform a data transfer to upload the linearity
test results to the workstation so a linearity
report can be generated.
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Unknown Solution Test
Periodically, you may be asked to perform a
proficiency test on a solution for which you do
not know the glucose value. This type of
testing may be required by your institution’s
accreditation organization.
1
Select Special Tests from
the Main Menu.
2
Select Lin/Unkn Test from
the Special Tests menu.
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Special Tests
3
Enter your operator ID.
Depending on the configuration option setting,
you may or may not be required to enter your
operator ID.
If your operator ID is required, a configuration
option may be set to remember your ID for up
to 1 hour after the bedside unit is turned off. If
your ID appears at the operator screen, press Ok
to confirm it is correct. If the ID is not correct,
simply enter your ID and it will replace the
existing ID.
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4
Select an option to identify
your unknown solution, for
example Unkn A.
5
Select the solution lot (or
identification) number
from the list displayed.
HIGH003
Depending on the configuration option setting,
you may be required to enter the unknown
solution lot number. If you are not required to
enter the lot number, the Select Lot # screen
will not appear.
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Special Tests
If you are required to enter the unknown
solution lot number, a configuration option
may have been selected which would allow you
to enter a new unknown solution lot number at
the bedside unit. If you do not see the lot
number in the list and the Enter Unk Lot #
button appears on the screen, press the button
and manually enter the unknown solution lot
number and expiration date.
6
Select the test strip lot
number (and code) from the
list displayed. The last test
strip lot number selected
appears at the top of the list.
Use the arrows to scroll
through the list if necessary.
Alternatively, scan the
barcode on the test strip
bottle label.
A configuration option may have been selected
which would allow you to enter a new test strip
lot number at the bedside unit. If you do not
see the lot number in the list and the Enter
Strip Lot button appears on the screen, press
the button and manually enter the test strip lot
number and CTL code.
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▲ CAUTION
To obtain accurate results, you must enter the
correct test strip lot number (and code) for each
new test.
7
Apply the unknown solution to the test strip.
• Touch the drop of solution to the center of
the pink test square.
If the white pad becomes completely
saturated, you have applied too much
solution. Repeat the application with a
new test strip.
• Check the confirmation dot on the back
of the test strip to verify it has turned
completely blue, indicating an adequate
amount of solution was applied.
If white patches or streaks are visible, you
have not applied enough solution. Repeat
the application with a new test strip.
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Special Tests
8
Firmly insert the test strip all the way into the
test strip holder until it stops (the
confirmation dot should be facing down).
▲ IMPORTANT
If you fail to completely insert the test strip,
the test may start; however, you may receive an
inaccurate, low result.
▲ IMPORTANT
You have up to 2 minutes to insert the test
strip after the solution is applied. If you insert
the test strip after 2 minutes, you may get an
inaccurate result or an error message. Discard
the test strip and repeat the test with a new test
strip.
The test result appears in
approximately 30 seconds.
Unkn
A
Result
mg/dL
▲ IMPORTANT
Do not remove the test strip
until the countdown is
complete.
Enter
Notes
Menu
Ok
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9
Press Ok to display the Lin/Unkn Test screen.
Or, if you wish to record additional
information with the test result, press Enter
Notes and choose a comment from the list.
Press Ok.
In-Service Test
Use the In-Service mode to train and certify
operators. This mode is identical to the QC
Test mode. However, In-Service test results
cannot be viewed in Review Data mode.
In-Service results are uploaded to the DataLink
workstation and appear in the All Datalog
Report.
1
Select Special Tests from the
Main Menu.
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Special Tests
2
Select In-Service Mode from
the Special Tests menu.
Menu
3
Follow the instructions in Chapter 2, Quality
Control Test, beginning with step 4. Use the
SureStepPro High, Low, and Normal Glucose
Control Solutions.
The QC warning or lockout mode does not
affect tests performed in the In-Service mode.
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CHAPTER 7
Troubleshooting
The SureStepPro Bedside Unit displays
prompts and error messages to indicate the
system has detected a problem with its internal
function, the test strip, or the testing
procedure. These messages help in resolving
some common problems that may occur during
testing. However, the bedside unit cannot
detect all problems. When the unit does detect
a problem, it may not produce an error
message every time the problem occurs. In
some situations, improper use may cause an
inaccurate result without producing an error
message.
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Troubleshooting
▲ CAUTION
While trying to resolve an error message using
the Troubleshooting section, keep in mind the
following:
• If patient symptoms indicate the need for
treatment, provide appropriate medical care
before you continue with troubleshooting.
• If you repeatedly get any error message or
you are otherwise unable to obtain a bedside
unit result, perform a laboratory test. Take
appropriate steps to monitor the patient and
provide medical care while awaiting the
laboratory result.
• After any test, you can compare the test strip
confirmation dot to the Color Chart on the
test strip bottle. If the comparison indicates
that the glucose level is very high or very
low, perform a laboratory test. Take
appropriate steps to monitor the patient and
provide medical care while awaiting the
laboratory result.
• Do not use the Color Chart as a replacement
for a bedside unit result.
If you need help resolving an error or you
encounter any other problem with the system,
contact the LifeScan Healthcare Professional
Line at:
1 800 524-7226 (USA)
1 888 353-0800 (Canada)
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Error Messages
POSSIBLE
CAUSE
ERROR
SOLUTION
Error 1
Sample
The bedside unit
1.Repeat test with new test
detected a problem strip and:
Application with the color of
the test strip.
• Apply blood to pink test
square only.
• Make sure confirmation
dot turns completely blue.
• Insert test strip within
2 min of applying blood.
2. Check that sample hemat-
ocrit is within range: adult
25–60%, neonatal 25–65%.
3.If you continue to get any
error message, obtain a
laboratory result, and
• Compare color of test
strip confirmation dot to
Color Chart on test strip
bottle to see if glucose
level is very high or very
low.
• Take appropriate steps
to monitor patient and
provide medical care while
awaiting laboratory result.
4.Clean bedside unit and
repeat test with new test
strip.
5.Contact LifeScan for help.
If you cannot resolve a problem, call LifeScan Healthcare Professional Line:
1 800 524-7226 (USA)
1 888 353-0800 (Canada)
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Troubleshooting
POSSIBLE
CAUSE
ERROR
SOLUTION
Error 2
Test Strip
The bedside unit
1.Repeat test with new test
detected a problem strip and:
with the test strip.
• Check test strip expira-
tion date. Do not use
expired test strips or test
strips beyond discard date.
• Apply sample to pink
test square only.
• Make sure confirmation
dot turns completely blue.
• Wait approximately
1 min but not more than
2 min after applying sam-
ple before inserting test
strip.
• Do not alter test strips.
2.If you continue to get any
error message, obtain a
laboratory result, and
• Compare color of test
strip confirmation dot to
Color Chart on test strip
bottle to see if glucose
level is very high or very
low.
• Take appropriate steps
to monitor patient and
provide medical care while
awaiting laboratory result.
3.Clean bedside unit and
repeat test with new test
strip.
4.Contact LifeScan for help.
If you cannot resolve a problem, call LifeScan Healthcare Professional Line:
1 800 524-7226 (USA)
1 888 353-0800 (Canada)
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POSSIBLE
CAUSE
ERROR
SOLUTION
Error 3
Test Strip
The bedside unit
1.Clean bedside unit,
detected a problem especially contact points in
withtheposition of lens area, but
the test strip.
NOTE: Before cleaning,
compare color of test strip
confirmation dot to Color
Chart on test strip bottle. If
glucose level is very high
or very low, take appropri-
ate steps to monitor
patient and provide
medical care.
• Repeat test with new
test strip.
• Do not move test strip
after you insert it. Remove
test strip only when test is
complete.
2.If you continue to get any
error message, obtain a
laboratory result. Take
appropriate steps to
monitor patient and
provide medical care while
awaiting laboratory result.
3.Contact LifeScan for help.
If you cannot resolve a problem, call LifeScan Healthcare Professional Line:
1 800 524-7226 (USA)
1 888 353-0800 (Canada)
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Troubleshooting
POSSIBLE
CAUSE
ERROR
Error 4
SOLUTION
The bedside unit
Temperature detected a
1.Repeat test with new test
strip. Make sure bedside
unit and test strip are at
room temperature.
Range
temperature
problem.
• Do not apply heat or
cold to unit (operating
temperature is 18°–30°C).
2.If you continue to get any
error message, obtain a
laboratory result, and
• Compare color of test
strip confirmation dot to
Color Chart on test strip
bottle to see if glucose
level is very high or very
low.
• Take appropriate steps
to monitor patient and
provide medical care while
awaiting laboratory result.
3.Contact LifeScan for help.
If you cannot resolve a problem, call LifeScan Healthcare Professional Line:
1 800 524-7226 (USA)
1 888 353-0800 (Canada)
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POSSIBLE
CAUSE
ERROR
Error 5
SOLUTION
The bedside unit
Meter Optics detected a problem especially gray area inside
1.Clean bedside unit,
with the optical
system.
test strip holder, but
NOTE: Before cleaning,
compare color of test strip
confirmation dot to Color
Chart on test strip bottle. If
glucose level is very high
or very low, take appropri-
ate steps to monitor
patient and provide
medical care.
• Repeat test with new
test strip.
• Make sure test strip
holder is fully inserted into
bedside unit.
• Wait for “Insert Strip” to
appear on display before
inserting test strip.
2.If you continue to get any
error message, obtain a
laboratory result. Take
appropriate steps to
monitor patient and
provide medical care while
awaiting laboratory result.
3.Contact LifeScan for help.
If you cannot resolve a problem, call LifeScan Healthcare Professional Line:
1 800 524-7226 (USA)
1 888 353-0800 (Canada)
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Troubleshooting
POSSIBLE
CAUSE
ERROR
Error 6
SOLUTION
The bedside unit
1.Wipe contact points in lens
System Error detected a problem area with cloth moistened
with the electronics. with water to remove
residual bleach. Dry
thoroughly, but
NOTE: Before cleaning
contact points, compare
color of test strip confirma-
tion dot to Color Chart on
test strip bottle. If glucose
level is very high or very low,
take appropriate steps to
monitor patient and provide
medical care.
• Repeat test with new
test strip.
• Make sure test strip lot
number (and code)
entered at bedside unit
matches number on test
strip bottle.
2.If you continue to get any
error message, obtain a
laboratory result. Take
appropriate steps to
monitor patient and
provide medical care while
awaiting laboratory result.
3.Contact LifeScan for help.
If you cannot resolve a problem, call LifeScan Healthcare Professional Line:
1 800 524-7226 (USA)
1 888 353-0800 (Canada)
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Unexpected Messages and Observations
POSSIBLE
CAUSE
MESSAGE
SOLUTION
Apply Blood Bedside unit is
ready for blood
Obtain a drop of capillary
blood and apply it to center
of pink test square.
application.
• If white pad becomes satu-
rated, you have applied
too much blood. Repeat
application with new test
strip.
• If white patches or streaks
appear on confirmation
dot, you have not applied
enough blood. Repeat
application with new test
strip.
Bedside Unit Bedside unit
Contact system
administrator for current
status of bedside unit.
Disabled
deleted from
system or
unassigned.
Bedside Unit Initial data transfer Transfer data.
Needs is required. Or,
Configuration configuration is
corrupted.
If you cannot resolve a problem, call LifeScan Healthcare Professional Line:
1 800 524-7226 (USA)
1 888 353-0800 (Canada)
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Troubleshooting
POSSIBLE
CAUSE
MESSAGE
SOLUTION
Check
1.Bedside unit was 1.Do not remove bedside
Connections
at Bedside
Unit
removed from
connection
unit from connection
module until link is
established and data are
transferred.
module before
connection was
established.
2. Bad connection 2.Checkconnectionbetween
between modem
and connection
module.
connection module and
modem.
3.Connection
module or
modem error.
3.Contact LifeScan.
Check
1. Workstation
modem not
turned on.
1.Turn on workstation
modem.
Connections
at
Workstation
2. Bad connection 2.Check modem connection
between modem
and wall jack.
at wall jack.
3. Workstation
modem error.
3.Contact LifeScan.
Check Phone 1.Bedside unit
1.If fax is being used by same
phone line as connection
module modem, wait for
fax machine and retry
connection.
Line
modem phone
line being used
by fax machine.
Connections
at Bedside
Unit
2. Bad connection 2.Check modem connection
between modem
and wall jack.
at wall jack.
3.Faulty phone line. 3.Inspect phone line.
If you cannot resolve a problem, call LifeScan Healthcare Professional Line:
1 800 524-7226 (USA)
1 888 353-0800 (Canada)
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POSSIBLE
CAUSE
MESSAGE
SOLUTION
Data
Less than 100 test Transfer data to free memory
Memory Low records can be
generated.
space.
DataTransfer Bedside unit/
Retry data transfer.
Error
workstation
communication
error.
Enter
High, low, or
Check ranges. Make sure min
value is less than max.
Narrower
normal control
Range(s) or range error.
Min<Max
Min>Max.
Insert Strip
Test strip not fully Remove test strip. When
appears after inserted into test “Insert Strip” appears, firmly
youinserttest strip holder.
strip.
insert test strip until it stops.
Internal
Faulty internal
Retry operation. If problem
Communica- communications. persists, do not use bedside
tion Error
unit. Contact LifeScan.
Internal Error System Error.
Power Down
Turn off bedside unit.
Contact LifeScan.
Invalid
Conflicting option Contact system
Configuration set, or
administrator to review
configuration settings.
Transfer data.
configuration
corrupted.
Invalid
Control
Value
Value
Re-enter correct control
>500 mg/dL was value.
entered.
Invalid CTL Expiration date not Check CTL code on control
Code
correct, or CTL code solution vial and re-enter it.
format invalid.
Invalid
Expiration
Date
Invalid month or Check expiration date and
year. Or, date
entered already
expired.
re-enter it.
If you cannot resolve a problem, call LifeScan Healthcare Professional Line:
1 800 524-7226 (USA)
1 888 353-0800 (Canada)
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Troubleshooting
POSSIBLE
CAUSE
MESSAGE
SOLUTION
Invalid
Operator ID format Re-enter your ID using
Operator ID not correct.
barcode scanner or
alphanumeric touch screen.
Invalid
Patient ID
Patient ID format Re-enter patient ID using
not correct.
barcode scanner or
alphanumeric touch screen.
Invalid
Phone
Number
Phone number not Re-enter phone number.
entered or more
than four pause
characters entered.
Invalid
Reagent lot
Check lot number and
Reagent Lot number not correct re-enter it.
Number
or field left blank.
Invalid Strip Strip lot number
Lot Number not correct. Less
than 10 digits were
Check lot number and
re-enter it.
entered, or code
out of range.
Low Battery Battery power low. Change batteries.
Modem Not Bedside unit
Check with your LifeScan
Supported by modem model not representative for modem
SureStepPro supported by
models supported.
System
software.
New
Reagent
Entry at
A workstation
option is set to
You cannot enter new
reagent from bedside unit.
allow reagent entry Use reagent from list, or ask
Workstation at workstation
Only only.
administrator to allow
reagent entry at bedside
unit.
No Room for There are five new Transfer data and validate
New (non-validated) new reagent lots.
Reagent Lot reagent lots in
bedside unit list.
If you cannot resolve a problem, call LifeScan Healthcare Professional Line:
1 800 524-7226 (USA)
1 888 353-0800 (Canada)
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POSSIBLE
CAUSE
MESSAGE
SOLUTION
No Room for Bedside unit
New Test
Data
Transfer data to free memory
space.
memory full.
No Room for There are five new Transfer data and validate
New Test
Strip Lot
(non-validated)
test strip lots in
bedside unit list.
new test strip lots.
Phone Line 1. Workstation
1.Workstation modem’s
phone line must be a
dedicated line. Do not
share line with a fax
machine.
Busy at
modem phone
line being used
by fax machine.
Workstation
2.Faulty telephone 2.Have phone line inspected.
line.
QC Due for Unit will be in QC Perform required QC tests
Bedside Unit lockout if required within 2 hours.
in Less than QC not performed
Two Hours within 2 hours.
QC Due:
QCMissedor test failed.
Failed
QC overdue or QC Successfully perform all
required QC tests.
Reagent Lot Reagent (solution) Enter and use new reagent
Expired
lot expired.
lot. Discard any remaining
expired reagent.
Remove Strip Not enough
Remove test strip. Check
confirmation dot. If white
patches or streaks appear, not
enough blood was applied for
an accurate result. Repeat test
with new test strip.
appears after sample on test
you insert
test strip.
strip or test strip
inserted too
quickly.
When “Insert Strip” appears,
firmly and more slowly insert
test strip until it stops.
If you cannot resolve a problem, call LifeScan Healthcare Professional Line:
1 800 524-7226 (USA)
1 888 353-0800 (Canada)
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Troubleshooting
POSSIBLE
CAUSE
MESSAGE
SOLUTION
Shake vial
and apply
(High,
Bedside unit is
Gently shake vial. Touch a
ready for control drop of solution to center of
solution
application.
pink test square.
Normal,
• If white pad becomes satu-
rated, you have applied
too much solution. Repeat
application with new strip.
• If white patches or streaks
appear on confirmation
dot, you have not applied
enough solution. Repeat
application with new strip.
Low) control
Strip Lot
Expired
Test strip lot
expired.
Enter and use new test strip
lot. Discard any remaining
expired test strips.
This QC Test QC solution level Do not perform QC test using
Not Required was not selected as this level unless you
required test by
administrator.
understand that if test is
performed and failsand QC
lockout mode was selected,
bedside unit will lock out
users until this test and all
required QC tests are
Continue?
performed and pass.
Upload
Overdue
Data transfer not Transfer data.
performed within
specified time.
Wrong
Reagent
Type
Type of reagent
Check reagent type (low,
(solution) entered normal, high, linearity, or
does not match
test type.
unknown) and re-enter
information.
If you cannot resolve a problem, call LifeScan Healthcare Professional Line:
1 800 524-7226 (USA)
1 888 353-0800 (Canada)
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APPENDIX A
Bedside Unit
Configuration Options
Following is a list of workstation options
configured by your System Administrator.
These options apply to all bedside units within
a nursing unit and directly affect how these
bedside units function.
Patient Results
Configuration Option
Meaning
Glucose units
▲ mg/dL
The units selected for
displaying and reporting
control and blood glucose
results.
▲ mmol/L
Patient Messages
Notes that appear at the
patient test result screen.
These notes allow you to
record a particular
situation with a test result.
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Bedside Unit
Configuration Options
Configuration Option
Meaning
Critical Warning
Messages
Notes that appear at the
patient test result screen
Lower Limit ____ when the test result falls
Upper Limit ____ outside the critical limits.
The notes are intended to
offer suggestions for
abnormal results.
The upper and lower limits
of the range for patient
results as defined by your
institution.
Patient Message
If a patient test result falls
Entry Required (for outside the critical limits,
results outside
critical limits)
▲ Yes
you may be required to
select a comment which
corresponds to the patient’s
current situation.
▲ No
Bedside Unit
Configuration Option
Meaning
▲ BU lockout if no If selected, the bedside
upload in ____
days
unit cannot be used for
testing if a data transfer
session has not been
performed within the
specified number of days
(maximum of 60 days).
▲ Bedside unit
beeper on
If selected, optional
bedside unit beeps are
enabled.
▲ Enable barcode
scanner
If selected, the bedside
unit barcode scanner is
enabled. If not selected,
you must enter all ID and
lot number information
manually.
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Configuration Option
Meaning
Nursing unit to
Each bedside unit is
which bedside unit assigned to a particular
is assigned
nursing unit. Do not use
the bedside unit outside
the designated nursing
unit.
▲ Reagent Entry at If selected, you must
Workstation Only choose an existing test
strip or control lot number
from the list displayed.
If not selected, you may
enter test strip and control
solution lot numbers that
have not yet been entered
in the system.
▲ Require Solution
If selected, you must select
LotNumber(High, (or enter) valid control and
Low, Normal,
Unknown,
Linearity)
linearity solution lot
numbers when performing
those tests.
Modem Dialing
Information
The workstation modem
phone number can be
preprogrammed. If
(option available for
preprogrammed, you do
SureStepPro 2.0 only) not need to enter the
phone number when
transferring data.
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Bedside Unit
Configuration Options
Operator and IDs
Configuration Option
Meaning
▲ ID required for all If selected, all operators are
tests
▲ Maintain ID
required to enter their IDs
for each test.
for ____
minutes after
power off
If Maintain ID is selected,
the last ID entered remains
in memory for 1 to 60
minutes from the time the
unit is turned off until it is
turned on again. Operators
need only confirm their ID
if it appears at the operator
ID screen.
▲ Patient ID required If selected, a patient ID is
for all tests
required.
ID number string
A string format was
format (patient and defined for all IDs entered
operator)
at the bedside unit. The
string defines the number
and type of characters
allowed (for example, five
alphanumeric characters).
Operator
Recertification
The period is the frequency
at which each operator
Period, ___months must be re-certified. Test
and test settings
settings define the number
of patient tests as well as
low, normal, and high QC
tests an operator must run
(test settings
available for
SureStepPro 2.0 only) within the re-certification
period to be eligible for
re-certification.
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Quality Control
Configuration Option
Meaning
Glucose units
▲ mg/dL
The units selected for
displaying and reporting
control and blood glucose
results.
▲ mmol/L
Required QC tests
▲ High
▲ Low
Three glucose controls are
available. Any combination
may be selected.
▲ Normal
Control solution
ranges (high, low,
The passing range for each
control solution level has
normal) for specified been defined. This range
test strip
may be the same as or
different from the range
found on the test strip
bottle label.
Result Display
Determines how quality
▲ Numeric Value control test results are
▲ Pass/Fail Only displayed.
(Pass/Failavailablefor
SureStepPro 2.0 only)
QC Enforcement
An option to ensure QC is
▲ Warning Only successfully completed as
▲ Bedside Unit
lockout
scheduled. Warning Only
displays a message but
▲ Operator
allows you to perform a
patient test. Bedside Unit
lockout displays the same
message but does not allow
you to perform a patient
test. Operator Lockout
Lockout
prevents the operator who
has not successfully per-
formed QC testing within
(Time period for
Operator Lockout is the designated time period
24 hours for
SureStepPro 1.2)
(1 to 365 days) from
performing a patient test.
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Bedside Unit
Configuration Options
Configuration Option
Meaning
QC Test Period
Frequency of performing a
▲ Time of day____ QC test is defined as a set
▲ Elapsed time
time each day or an elapsed
time between 6 and 24
hours.
____ hours
QC Action Messages Messages displayed in the
bedside unit following a
failed QC test. These
messages allow you to
record the steps taken to
correct the problem.You
are required to select at
least one message.
Failed QC Guiding Messages that appear at a
Messages
QC result screen when the
test fails. These messages
offer possible reasons why
the test failed.
Failed QC Message If a QC test result fails, you
Entry Required
▲ Yes
▲ No
may be required to select a
comment that corresponds
to the failed test result.
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Specifications
The performance of the system has been
evaluated under the conditions listed below.
Refer to the SureStepPro Test Strips package
insert for typical accuracy and precision data.
Bedside Unit Specifications
power supply:
two size C, 1.5-V
alkaline batteries
result range:
display:
0–500 mg/dL
liquid crystal
whole blood
sample type:
calibration:
plasma equivalent
hematocrit range: 25–60%
(neonatal 25–65%)
meter size:
height 18.9 cm (7.4 in)
width 8.8 cm (3.5 in)
depth 6.5 cm (2.6 in)
meter weight:
1.2 lb
operating
temperature:
18°–30°C (64°–86°F)
97
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Specifications
operating humidity: 30%–70% relative
humidity
(noncondensing)
altitude:
up to 10,000 ft (3048 m)
[For more information,
read the SureStepPro Test
Strip package insert.]
class II laser:
barcodes:
680 nm
Barcode 39
Barcode 128
Example of Code 39
Example of Code 128
Barcode Specifications
• Black and white only; no color background.
• 1/4-in border surrounding barcode symbol
(optimal).
• Accepts the first 14 alphanumeric characters
in a barcode that contains a maximum of 18
characters; special characters include: (space)
(-) (\) (/) (:) (;) (,) (_) (.)
• Medium density (X dimension of 0.012
inches) or high density (X dimension of
0.0075 inches), where density is the number
of characters per inch and X dimension is the
width of the narrowest element in the symbol.
98
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The SureStepPro Blood Glucose Bedside Unit
complies with the following standards:
• CAN/CSA - C22.2 No. 601.1-94 Medical
Electrical Equipment - Part 1: General
Requirements for Safety (Complies with UL
2601-1 and IEC 601-1)
• CAN/CSA - C108.6-M91 (CISPR 11:1990)
Limits and Methods of Measurement of
Electromagnetic Disturbance Characteristics
in Industrial, Scientific and Medical (ISM)
Radio-Frequency Equipment (Complies with
Canadian ICES-001)
• CAN/CSA - C22.2 No. 1010.1-92 Safety
Requirements for Electrical Equipment for
Measurement, Control, and Laboratory Use,
Part 1: General Requirements (Complies
with IEC 1010-1)
• CAN/CSA - C22.2 No. 601.1.2-94 Medical
Electrical Equipment Part 1: General
Requirements for Safety-2. Collateral
Standard: Electromagnetic Compatibility -
Requirements and Tests (Complies with
IEC 601-1-2)
Type BF Equipment
• Internally powered equipment
• No patient-applied parts
• This unit is not suitable for use
in the presence of a flammable
anaesthetic mixture with air, oxygen,
or nitrous oxide.
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Specifications
Cleaning Agents
The following compounds can be used to clean
the exterior only of the bedside unit. Follow the
instructions for use on the product’s packaging.
Refer to Chapter 5, Care and Maintenance, for
cleaning precautions and detailed information
on cleaning the bedside unit and test strip
holder.
• water
• 10%bleach
• 70% isopropyl alcohol
• 12.5% ammonia
®
• 10% Bacdown
®
• 30% Cavicide
®
• Cidex (glutaraldehyde)
®
• Cidex Plus
• Progard™
• Softgard™
®
• Hibiclens
®
• 22% Lysol
• Sanicloth™
®
• Staphene
• 5.5% WEX-Cide™
Product names may be trademarks of their
respective owners.
100
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Index
lens area 55–56
solution 54
a
applying
blood 33–36
control solution 22–23
test strip holder 54–55
Color Chart 12, 13, 39
confirmation dot 10, 23
contact points 3
b
barcode scanner 3
cleaning 56
using 8
cleaning 55
barcode specifications 98
barcode specs 98
batteries
changing 57–59
status 18, 30, 57
bedside unit
control (CTL) code 11
control solution 17
applying 22–23
at high altitudes 17
out-of-range result 24
results 24–26
batteries 4, 57
CTL code 11, 21
data transfer 41–48
description 1, 3–4
memory 49
d
data
reviewing 49–52
transferring 41–48
operation 5–9
screen contrast 60
specifications 97–99
beep signals 9
e
entering
information 6–8
error codes 79–84
blood application 33–36
c
cleaning
g
agents 100
barcode scanner 56
contact points 55
glucose control solution 17
glucose range 38
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Index
i
p
ID
operator 7
patient 31
patient ID 31
patient results
critical values 38–39
displayed 38–39
reviewing 50
infection control 14
insert test strip 23, 37, 66, 74
in-service test 75–76
patient test 29–40
power button 3
precautions 12
l
laser information ii, 4
LCD screen 3
contrast 60
q
QC lockout 15
quality control results
displayed 24–26
reviewing 51
lens area 3
cleaning 55–56
linearity test 61–68
result 67
upper limit 67
lockout
quality control solution
applying 22–23
data transfer 41
operator 15
QC 15
lot numbers
reviewing 52
quality control test 18–27
r
results
critical 38–39
linearity 67
m
patient 38–39
quality control 24–26
unknown solution 74
reviewing data 49–52
main menu 6
memory, bedside unit 49
messages
error 79–84
unexpected 85–90
s
scanning a barcode 8
screen contrast 60
special tests
o
operator
ID 7
in-service 75–76
linearity 61–68
unknown solution 69–75
Status screen 18, 30, 57
system administrator 1, 5
system beep signals 9
lockout 15
out-of-range result
control test 24
linearity test 67
102
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t
test
in-service 75–76
linearity 61–68
patient 29–40
quality control 18–27
unknown solution 69–75
test strip
blood application 33–36
control application 22–23
general information 9–12
inserting 23, 37, 66, 74
lotnumber 21, 32, 64, 72
test strip holder 3, 4
cleaning 54–55
removing 54
transferring data 41–48
troubleshooting
error messages 79–84
unexpected messages 85–90
u
unknown solution test 69–75
w
workstation 1–2
103
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For use with bedside units, versions 1.2 and 2.0.
AW 061-296-01A
©2002 LifeScan, Inc.
09/02
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