Lifescan SureStep Pro Manual

Bedside Unit Operator’s Guide
BU.book Page 1 Monday, October28, 2002 11:14 PM

BU.book Page 2 Monday, October28, 2002 11:14 PM

i
The SureStep®Pro Bedside Unit is for in vitro
diagnostic use for the quantitative
measurement of glucose in venous, capillary,
arterial, and neonatal whole blood samples.
It should not be used for the
diagnosis of diabetes.
BU.book Page i Monday, October 28, 2002 11:14 PM

ii
▲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.
BU.book Page ii Monday, October 28, 2002 11:14 PM

iii
Table of Contents
Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . v
About This Guide . . . . . . . . . . . . . . . . . . . vi
What You’ll Find in This Guide. . . . . . . vi
Conventions Used in This Guide . . . . . . . viii
Help . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ix
CHAPTER 1–Introduction . . . . . . . . . . . . . 1
The Bedside Unit . . . . . . . . . . . . . . . . . . . . . 3
General Operating Information . . . . . . . . . . 5
Entering Information . . . . . . . . . . . . . . . . 6
Scanning a Barcode . . . . . . . . . . . . . . . . . 8
System Beep Signals . . . . . . . . . . . . . . . . . 9
SureStepPro Test Strips . . . . . . . . . . . . . . . . 9
Precautions . . . . . . . . . . . . . . . . . . . . . . . . 12
Infection Control . . . . . . . . . . . . . . . . . . 14
CHAPTER 2–Quality Control Test . . . . . . 15
When to Perform a Quality Control Test . . 16
Glucose Control Solutions . . . . . . . . . . . . . 17
Performing a Quality Control Test . . . . . . . 18
Applying Control Solution to Test Strip. 22
CHAPTER 3–Patient Test . . . . . . . . . . . . . 29
Performing a Patient Test . . . . . . . . . . . . . 29
Applying Blood Sample to Test Strip . . . 33
BU.book Page iii Monday, October 28, 2002 11:14 PM

Table of Contents
iv
CHAPTER 4–Data Management . . . . . . . 41
Transferring Data to the Workstation . . . . 41
Using a Direct Infrared Port Connection 42
Using the Connection Module. . . . . . . . 44
Bedside Unit Memory . . . . . . . . . . . . . . . . 49
Accessing Memory to Review Data . . . . 49
CHAPTER 5–Care and Maintenance . . . . 53
General Care . . . . . . . . . . . . . . . . . . . . . . . 53
When to Clean the Unit . . . . . . . . . . . . 53
Cleaning the Outside of the Unit . . . . . . . 54
Cleaning the Test Strip Holder and Lens . . 54
Changing the Batteries . . . . . . . . . . . . . . . 57
Adjusting the Screen Contrast . . . . . . . . . . 60
CHAPTER 6–Special Tests . . . . . . . . . . . . 61
Linearity Test . . . . . . . . . . . . . . . . . . . . . . 61
Unknown Solution Test . . . . . . . . . . . . . . 69
In-Service Test . . . . . . . . . . . . . . . . . . . . . 75
CHAPTER 7–Troubleshooting . . . . . . . . 77
Error Messages . . . . . . . . . . . . . . . . . . . . . 79
Unexpected Messages and Observations . . 85
APPENDIX A–Bedside Unit
Configuration Options . . . . . . . . . . . . . 91
Specifications . . . . . . . . . . . . . . . . . . . . . 97
Bedside Unit Specifications . . . . . . . . . . . . 97
Barcode Specifications . . . . . . . . . . . . . . . . 98
Cleaning Agents . . . . . . . . . . . . . . . . . . . 100
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . 101
BU.book Page iv Monday, October 28, 2002 11:14 PM

v
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.
BU.book Page v Monday, October28, 2002 11:14 PM

Preface
vi
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.
BU.book Page vi Monday, October28, 2002 11:14 PM

vii
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.
BU.book Page vii Monday, October28, 2002 11:14 PM

Preface
viii
Conventions Used in This Guide
■NOTE
Points out additional information that may be
helpful.
◆IMPORTANT
Contains information necessary to successfully
perform the test.
▲CAUTION
Alerts you to situations that could result in
instrument damage, failure in a procedure, or
possible inaccurate results.
Text within shaded boxes appears throughout
this guide. This information describes a
specific workstation option and how it may
affect bedside unit operation.
For example:
Enter your operator ID.
For a list of workstation options that are
reflected in the bedside unit, refer to
Appendix A, Bedside Unit Configuration
Options.
Depending on the configuration option setting,
you may or may not be required to enter your
operator ID.
1
BU.book Page viii Monday, October 28, 2002 11:14 PM

ix
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)
BU.book Page ix Monday, October 28, 2002 11:14 PM

Preface
x
BU.book Page x Monday, October28, 2002 11:14 PM

1
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.
BU.book Page 1 Monday, October28, 2002 11:14 PM

Introduction
2
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.
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.
*Computer products may vary from those shown.
*
BU.book Page 2 Monday, October28, 2002 11:14 PM

3
The Bedside Unit
▲CAUTION
Do not stare into the barcode scanner or point it
towards anyone’s eyes while the laser light is on.
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.
FRONT
BU.book Page 3 Monday, October28, 2002 11:14 PM

Introduction
4
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.
TEST STRIP HOLDER
Opened
The test strip holder is interchangeable—the
same holder may be used in any SureStep brand
meter.
Closed
BACK
Battery Compartment holds
two size C alkaline batteries.
BU.book Page 4 Monday, October28, 2002 11:14 PM

5
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.
BU.book Page 5 Monday, October28, 2002 11:14 PM

Introduction
6
A Main Menu lets you select from six different
functions.
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.
Patient Test allows you to run a
patient test.
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.
Review Data displays stored test
results and reagent lot numbers.
Transfer Data transfers data
between bedside unit and workstation.
QC Test allows you to run a quality
control test.
Last Upload displays the date and time of the
last successful data transfer session (SureStepPro
2.0 only).
BU.book Page 6 Monday, October28, 2002 11:14 PM

7
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.
BU.book Page 7 Monday, October28, 2002 11:14 PM

Introduction
8
Scanning a Barcode
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.
▲CAUTION
This product contains a laser. Do not stare into
the laser light or point it towards anyone’s eyes
while 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.
Press Release
BU.book Page 8 Monday, October28, 2002 11:14 PM