Lifescan SureStepFlexx Manual

The SureStep®Flexx Meter is for in vitro diagnostic use
for the quantitative measurement of glucose
in venous, capillary, arterial, and neonatal
whole blood samples. It should not be used
for the diagnosis of diabetes.
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This meter may contain a barcode scanner. The label on
the back of the meter indicates if a scanner is installed.
If the meter does not contain a barcode scanner, you
may add one. The scanner will be shipped with a new
battery compartment door that has the appropriate
barcode scanner label. For meters equipped with a
barcode scanner, the following precaution applies:
▲CAUTION: This product contains a barcode scanner.
It is a class II laser which operates at 640–690 nm
and emits 0.2 mW of energy. This product meets 21
CFR (Code of Federal Regulations) 1040.10* and
1040.11* laser light when activated.
Do not stare into the laser beam. Refer to page 10 for
instructions on barcode scanner operation.
©2002, 2000 LifeScan, Inc. All rights reserved.
The system described herein is covered by one or more of the following US
patents: D444,235, D367,109, 5,418,142, 5,515,170, 5,526,120, 5,563,031,
5,605,837, 5,780,304, 5,789,255, 5,922,530, 5,968,836, and 6,335,203.
Use of the system described herein is protected under the US patent
4,935,346. Purchase of the system described herein does not act to grant a
license under these patents. Such a license is granted only when the device is
used with SureStepPro or OneTouch SureStep Test Strips. No test strip supplier
other than LifeScan is authorized to grant such a license, and LifeScan does not
endorse or encourage the use of any strips manufactured by anyone other than
LifeScan.
*Food and Drug Administration (FDA) regulations established
for any product that contains a laser.
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iii
Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vii
About This Guide . . . . . . . . . . . . . . . . . . . . . . . . . viii
What You’ll Find in This Guide . . . . . . . . . . . viii
Conventions Used in This Guide . . . . . . . . . . . . ix
Help . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . x
Chapter 1: Introduction. . . . . . . . . . . . . . . . . . . 1
Meter Configuration . . . . . . . . . . . . . . . . . . . . . . . . . 2
Meter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Test Strip Holder . . . . . . . . . . . . . . . . . . . . . . . . . 5
General Operating Information . . . . . . . . . . . . . . . . . 6
Status Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Main Menu and Quick Keys. . . . . . . . . . . . . . . . . 8
Entering Information . . . . . . . . . . . . . . . . . . . . . . 8
Scanning a Barcode . . . . . . . . . . . . . . . . . . . . . . 10
System Beep Signals. . . . . . . . . . . . . . . . . . . . . . 11
SureStepPro Test Strips . . . . . . . . . . . . . . . . . . . . . . 12
Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Infection Control . . . . . . . . . . . . . . . . . . . . . . . . 15
Chapter 2: Quality Control Test . . . . . . . . . . . 17
When to Perform a Quality Control Test. . . . . . . . . 19
Glucose Control Solutions . . . . . . . . . . . . . . . . . . . . 20
Performing a Quality Control Test . . . . . . . . . . . . . 21
Setting Up the Meter . . . . . . . . . . . . . . . . . . . . . 21
Applying Control Solution to the Test Strip. . . . 25
Inserting the Test Strip . . . . . . . . . . . . . . . . . . . 26
Control Solution Results . . . . . . . . . . . . . . . . . . 27
Contents
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iv
Chapter 3: Patient Test . . . . . . . . . . . . . . . . . . 29
Performing a Patient Test . . . . . . . . . . . . . . . . . . . . 30
Setting Up the Meter . . . . . . . . . . . . . . . . . . . . . 30
Applying Blood Sample to the Test Strip . . . . . . 33
Inserting the Test Strip . . . . . . . . . . . . . . . . . . . 36
Patient Results. . . . . . . . . . . . . . . . . . . . . . . . . . 36
Chapter 4: Data Transfer and Management. . 39
Transferring Data . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Using a Connection Module. . . . . . . . . . . . . . . . 40
Using a Serial Cable . . . . . . . . . . . . . . . . . . . . . . 43
Entering a Receiving Modem Phone Number . . 44
Meter Memory. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Reviewing Data . . . . . . . . . . . . . . . . . . . . . . . . . 45
Chapter 5: Special Tests . . . . . . . . . . . . . . . . . 49
Linearity Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
Unknown Solution Test. . . . . . . . . . . . . . . . . . . . . . 56
In-Service Test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
Chapter 6: Care and Maintenance . . . . . . . . . . 63
General Care . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
When to Clean the Meter. . . . . . . . . . . . . . . . . . 64
Cleaning the Outside of the Meter . . . . . . . . . . . 64
Cleaning the Test Strip Holder and Lens . . . . . . 65
Changing the Batteries . . . . . . . . . . . . . . . . . . . . . . 68
Adjusting the Screen Contrast . . . . . . . . . . . . . . . . . 70
Setting the Date and Time . . . . . . . . . . . . . . . . . . . 71
Changing the Receiving Modem Phone Number. . . 72
Installing a Barcode Scanner . . . . . . . . . . . . . . . . . . 73
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v
Chapter 7: Troubleshooting . . . . . . . . . . . . . . 77
Error Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
Unexpected Messages and Observations. . . . . . . . . . 84
Appendix A: Meter Configuration Options . . 91
Patient Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
Meter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92
Operator and IDs. . . . . . . . . . . . . . . . . . . . . . . . . . . 93
Quality Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94
Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . 97
Meter Specifications. . . . . . . . . . . . . . . . . . . . . . . . . 97
Barcode Specifications . . . . . . . . . . . . . . . . . . . . . . . 98
Cleaning Agents . . . . . . . . . . . . . . . . . . . . . . . . . . 100
Index. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101
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vi
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Preface vii
Preface
SureStepFlexx Professional Blood Glucose
Management System is LifeScan’s integrated system
for testing, tracking, and managing patient and
quality control data.
The SureStepFlexx System offers diabetes caregivers
and patients off-meter blood dosing of the test strip.
This design can help reduce the risk of transmission of
blood-borne pathogens between patients, while
providing accurate and reliable blood glucose results
at the point of patient care.
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viii SureStepFlexx Meter Operator’s Guide
About This Guide
The SureStepFlexx Meter Operator’s Guide provides
detailed instructions on using and maintaining the
SureStepFlexx Meter. Because meter settings may vary
depending on how the meter is configured, you will
benefit by becoming familiar with the configuration
options. For more detailed information on
configuration options, ask your system administrator
or refer to Appendix A, Meter Configuration Options,
for a list of default stand-alone meter options, as well
as options configured at a workstation.
What You’ll Find in This Guide
Chapter 1, Introduction, provides you with an
overview of the system and outlines basic meter
operating instructions.
Chapter 2, Quality Control Test, guides you through
the steps to perform a quality control test.
Chapter 3, Patient Test, guides you through the steps
to perform a patient blood test.
Chapter 4, Data Transfer and Management, covers the
transfer of data between the meters and the
workstation. It also provides information on reviewing
test results stored in meter memory.
Chapter 5, Special Tests, provides instructions for
performing a linearity test, an unknown solution test,
and an in-service test.
Chapter 6, Care and Maintenance, instructs you on
how to clean the meter and test strip holder, change
the batteries, and install a barcode scanner.
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Preface ix
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, Meter Configuration Options, includes a
list of all meter options and the default settings for
meters in stand-alone mode.
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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xSureStepFlexx Meter Operator’s Guide
Text within shaded boxes appears throughout this
guide. This information provides you with the specific
workstation option that may affect how individual
meters operate. In some cases, a brief explanation is
included to describe the option.
If your meter operates in stand-alone mode, these
options were preset before the meter was shipped to
you. For information on stand-alone meters, refer to
“Meter Configuration” on page 2.
For example:
1Enter your operator ID.
For a list of workstation options that are reflected in
the meter, refer to Appendix A, Meter Configuration
Options.
Help
1Read through the section of the guide specific to
the operation you are performing. Refer to the table
of contents and index to locate information.
2See Chapter 7 for error messages and troubleshooting
information.
3Call LifeScan Healthcare Professional Line at:
1 800 524-7226 (USA)
1 888 353-0800 (Canada)
❑Operator ID required for all tests
❑ Maintain ID for ___ min. after power off
If your ID appears at the operator ID screen,
press to confirm it is correct. If the ID is
not correct or does not appear, enter your ID.
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1
Introduction
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2SureStepFlexx Meter Operator’s Guide
The SureStepFlexx 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 test strip is
inserted into the meter. A confirmation dot on the test
strip helps you check that an adequate volume of
sample was applied.
A large touch-sensitive display allows you to manually
enter operator, patient, and reagent information. An
optional barcode scanner is available so that
information can be quickly scanned into the meter.
Meter Configuration
Each meter is shipped with default settings. A meter
that operates with the default settings is referred to as a
stand-alone meter. You may use the meter with the
default configuration, or you may use LifeScan’s
DataLink™ Data Management System software to
customize a configuration for your institution’s specific
needs. For a list of the predefined stand-alone settings,
refer to Appendix A, Meter Configuration Options.
Main Menu
Patient Test
QC Test
Review Data
Special Tests
Setup
Stand-alone mode
Meter is used with
preconfigured settings.
DataLink mode
Meter settings are customized
using DataLink software.
*Computer equipment may vary from that shown.
*
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Chapter 1: Introduction 3
If you are using LifeScan DataLink software to configure
your institution’s meters, your system administrator has
defined a set of options from a central workstation.
The meter stores patient and quality control data in
memory. This information can be recalled and
manually recorded in a log book, if you are using the
meter in stand-alone mode. Or, the data can be
uploaded to the workstation through a bi-directional
data transfer, if you are using the meter in DataLink
mode. During this transfer session, test results are sent
from the meter to the workstation and configuration
settings are sent from the workstation to the meter.
Several communication options are available: serial
connection, modems, or a network. A LifeScan
representative can assist you with information on the
appropriate connectivity solutions for your institution.
The complete SureStepFlexx Professional Blood
Glucose Management System includes a computer
workstation with DataLink Data Management System
software (or equivalent data management software
such as Rals®-Plus or QML™), meters, test strips,
glucose control solutions, glucose linearity kit, and
carrying cases.
For important information on any of these LifeScan
products, refer to the appropriate operator’s guide or
package insert. It is important that you read and
understand all instructions before you operate the
system.
Rals is a registered trademark of MAS, Inc.
QML is a trademark of TELCOR Inc.
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4SureStepFlexx Meter Operator’s Guide
Meter
Power button turns
the meter on and off.
Test strip holder covers the
lens area and holds the test
strip. The holder slides out of
the meter for easy cleaning.
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.
Scanner/Infrared (SIR)
communication port (optional)
enables direct data entry for
operator ID, patient ID, and control
solution and test strip lot numbers
from their respective barcodes.
Communicates with the workstation,
via a DataLink connection module.
Lens area, located under the
test strip holder, contains the
optics that reads the glucose level
on the test strip.
Contact points, located under
the test strip holder, sense the
position and orientation of the
test strip.
FRONT
Serial port (top of meter)
allows for communication
with a workstation.
Quick keys
(See page 8 for
descriptions.)
▲CAUTION: Do not stare into the barcode scanner or
point it towards anyone’s eyes while the laser light is on.
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Chapter 1: Introduction 5
Test Strip Holder
The test strip holder is interchangeable—the same
holder may be used in any SureStep brand meter.
The insertion point is the area
where the test strip is inserted.
The base holds the
test strip in place.
The cover protects the lens.
Closed
Open
Battery Compartment holds
three size AA alkaline batteries.
BACK
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6SureStepFlexx Meter Operator’s Guide
General Operating Information
If your institution uses DataLink software to custom
configure the meter, your system administrator will
select options that will determine how each meter
operates. By familiarizing yourself with the
configuration for the meter you are operating, you
will know what to expect when performing QC and
patient tests. You may request a Location Configuration
Report from your system administrator. This report
lists each option that was selected for all meters within
a selected location of your institution.
If your meter is configured for stand-alone mode and
you wish to change the settings, contact your LifeScan
representative.
Status Screen
When you turn on the meter, a clock briefly flashes,
followed by a screen displaying .
Then the status screen appears. The status screen
provides information about your meter configuration.
The meter serial number and tag are displayed at the
top of the status screen.
L7038XX00114
Battery
QC Due in 12:13
F
E
02/26/99 08:05
Cont
A
M
DataLink inactive
Clinic
L7038XX00115
Battery
QC Due now!
Upload Due: 10day(s)
Last upload passed:
F
E
@ 12/20/99 12:15
12/21/99 08:05
Cont
A
M
A
M
ER
1
2
3
4
5
Status screen for meter in
stand-alone mode.
Status screen for meter
configured by a workstation.
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Chapter 1: Introduction 7
1The first line under the meter serial number
indicates when QC is due.
2The second line indicates when an upload is due.
If the meter is stand-alone, or if configured by a
workstation but no upload lockout was set, this
line is blank.
3The third line displays Last upload passed/
failed: for meters configured by a workstation.
If the meter is in stand-alone mode, DataLink
inactive is displayed.
4The fourth line indicates the date and time of
the last upload. If the meter is in stand-alone
mode, this line is blank.
5The fifth line displays a battery bar which gives
the approximate status of battery power. If there
is insufficient power to perform a test, the meter
displays a warning message.
The current date and time are displayed at the bottom
of the screen. If the meter was configured by a
workstation, the date and time were downloaded from
the workstation. If the meter is in stand-alone mode,
the date and time were set prior to shipping the meter.
You can change the date and time settings for stand-
alone meters from the Setup screen (see “Setting the
Date and Time” on page 71).
Press Cont to advance to the Main Menu. Or, after a
few seconds the meter automatically advances to the
Main Menu. To access the status screen again, you
must turn the meter off, then on again.
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8SureStepFlexx Meter Operator’s Guide
Main Menu and Quick Keys
A Main Menu provides you with five different options.
Entering Information
Select an item from a list by touching the appropriate
area of the screen. If a list does not fit on one screen,
arrow buttons allow you to scroll through the list.
Patient Test allows you to perform a
patient test.
Special Tests allows you to perform
linearity and unknown tests and perform
in-service testing.
Setup allows you to enter a modem
phone number, adjust the LCD contrast,
and set the date/time (stand-alone meter
only).
Review Data displays stored test
results and reagent lot numbers.
QC Test allows you to perform a quality
control test.
Back takes you back to the previous screen.
Menu takes you to the menu that was last displayed.
Ok accepts information entered or displayed.
Quick Keys
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