Abbott FreeStyle Precision Pro User manual

Operator’s Manual
for Healthcare Professionals

i
Questions? Refer to Page 11-22 For Technical Support Instructions.
Table of Contents
is Operator's Manual provides basic information about the FreeStyle Precision Pro system. It is organised into three
sections. e overview in Chapter 1 describes the components of the FreeStyle Precision Pro system and the physical
features of the meter. Chapters 2 to 9 give step-by-step procedures to operate the meter. Chapters 10 to 13 provide additional
information to help care for the meter.
1. Overview........................................................................................................................................................................ 1
Intended Use .......................................................................................................................................................................................1-1
Important Safety Instructions ..........................................................................................................................................................1-1
TrueID..................................................................................................................................................................................................1-3
TrueMeasure .......................................................................................................................................................................................1-3
TrueAccess...........................................................................................................................................................................................1-4
Notes and Warnings ...........................................................................................................................................................................1-5
Meter Display Icons............................................................................................................................................................................1-6
Conventions ........................................................................................................................................................................................1-7
System Components...........................................................................................................................................................................1-8
2. Using the Meter............................................................................................................................................................. 2
Barcode Scanner .................................................................................................................................................................................2-1
Data Entry Keypad.............................................................................................................................................................................2-3
Audible Indicator................................................................................................................................................................................2-5
Data Port..............................................................................................................................................................................................2-5

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Questions? Refer to Page 11-22 For Technical Support Instructions.
Battery Compartment ........................................................................................................................................................................2-5
Strip Port Module ...............................................................................................................................................................................2-6
Optional Wireless Network Connection.........................................................................................................................................2-6
Meter Identication............................................................................................................................................................................2-8
Menu Tree............................................................................................................................................................................................2-8
3. Patient Test .................................................................................................................................................................... 3
Operating Guidelines for All Samples .............................................................................................................................................3-1
Collecting Blood Samples..................................................................................................................................................................3-3
How to Obtain a Capillary Blood Sample (For Glucose or Ketone Testing)..........................................................................3-3
How to Obtain a Venous Blood Sample (For Glucose or Ketone Testing) .............................................................................3-4
How to Obtain an Arterial Blood Sample (For Glucose Testing) ............................................................................................3-5
How to Obtain a Neonatal Capillary Blood Heel Stick Sample (For Glucose Testing).........................................................3-5
Disposing of Waste.............................................................................................................................................................................3-6
Patient Test Procedure - FreeStyle Precision Pro Glucose ............................................................................................................3-7
Patient Test Procedure - Precision Xceed Pro Glucose ...............................................................................................................3-15
Patient Test Procedure - Ketone .....................................................................................................................................................3-23
4. Control Test ................................................................................................................................................................... 4
Operating Guidelines for Control Solution Testing.......................................................................................................................4-1
Control Test Procedure - Glucose ....................................................................................................................................................4-4
Control Test Procedure - Ketone................................................................................................................................................... 4-11
Table of Contents continued

iii
Questions? Refer to Page 11-22 For Technical Support Instructions.
5. Data Review................................................................................................................................................................... 5
Data Review for Patient by Operator ID .........................................................................................................................................5-4
Data Review for Patient by Patient ID .............................................................................................................................................5-6
Data Review for All Patient Data......................................................................................................................................................5-8
Data Review for Control Data ........................................................................................................................................................5-10
Data Review for Prociency Data ..................................................................................................................................................5-12
Data Review for Linearity Data ......................................................................................................................................................5-14
6. Prociency Test ............................................................................................................................................................. 6
Prociency Test - Glucose ................................................................................................................................................................ 6-1
Prociency Test - Ketone (Beta-Hydroxybutyrate)....................................................................................................................... 6-7
7. Linearity Test ................................................................................................................................................................. 7
8. Review Setup................................................................................................................................................................. 8
Meter Conguration ..........................................................................................................................................................................8-1
Review Setup.......................................................................................................................................................................................8-6
Review Test Setup for All Tests.........................................................................................................................................................8-8
Review Test Setup for Test Type .....................................................................................................................................................8-11
Review Test Setup for Patient Test..................................................................................................................................................8-14
Review Test Setup for Control Test ................................................................................................................................................8-17
Review Test Setup for Security........................................................................................................................................................8-20
System Status.....................................................................................................................................................................................8-24
Table of Contents continued

iv
Questions? Refer to Page 11-22 For Technical Support Instructions.
9. Review Setup for Wireless Communication (Optional).............................................................................................. 9
Meter Wireless Conguration ..........................................................................................................................................................9-1
10. Data Upload................................................................................................................................................................. 10
Docking Station Upload ..................................................................................................................................................................10-1
Wireless Transfer (if enabled) .........................................................................................................................................................10-2
Docking Station ...............................................................................................................................................................................10-4
Mounting Instructions.....................................................................................................................................................................10-4
Enabling Data Upload......................................................................................................................................................................10-5
11. Troubleshooting ......................................................................................................................................................... 11
Troubleshooting Patient Test Results.............................................................................................................................................11-1
Troubleshooting Out-of-Range Control Test Results..................................................................................................................11-2
Troubleshooting Out-of-Range Linearity Test Results................................................................................................................11-3
Troubleshooting Wireless (if enabled)...........................................................................................................................................11-4
Troubleshooting Barcode Scanning ...............................................................................................................................................11-4
Error Messages..................................................................................................................................................................................11-5
Technical Support Instructions ....................................................................................................................................................11-22
Returning a Meter ..........................................................................................................................................................................11-23
Contacting Abbott for Service ......................................................................................................................................................11-24
Table of Contents continued

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Questions? Refer to Page 11-22 For Technical Support Instructions.
12. Maintenance................................................................................................................................................................ 12
Cleaning the Exterior Surface.........................................................................................................................................................12-1
Replacing the Strip Port Module....................................................................................................................................................12-3
Replacing the Batteries.....................................................................................................................................................................12-5
13. Specications .............................................................................................................................................................. 13
FreeStyle Precision Pro Meter.........................................................................................................................................................13-1
Symbols..............................................................................................................................................................................................13-3
Barcode Types...................................................................................................................................................................................13-6
Table of Contents continued

1. Overview
Intended Use
Important Safety Instructions
TrueID
TrueMeasure
TrueAccess
Notes and Warnings
Meter Display Icons
Conventions
System Components

1-1
Questions? Refer to Page 11-22 For Technical Support Instructions.
Overview
Intended Use
e FreeStyle Precision Pro Blood Glucose and β-Ketone Monitoring System is intended for in vitro (outside the body) diagnostic
use for the quantitative measurement of glucose (D-glucose) in fresh capillary whole blood (ngertip), and of ketone (beta-
hydroxybutyrate) in fresh capillary whole blood samples. e FreeStyle Precision Pro system is for professional use. e system
is not for use in diagnosing diabetes mellitus, but is to be used as an aid in monitoring the eectiveness of diabetes control
programmes.
Healthcare professionals may also use the product for the quantitative measurement of glucose in venous, arterial or neonatal
whole blood and ketone in venous blood, provided the sample is used within 30 minutes aer collection.
e FreeStyle Precision Pro system simplies point-of-care testing for healthcare professionals, providing features that enhance
the reliability of the testing process and that support compliance with point-of-care policies.
Important Safety Instructions
DANGER
• Misuse of electrical equipment can cause electrocution, burns, fire and other hazards.
• Basic safety precautions should always be taken, including all those listed below.
• Close supervision is necessary when equipment is used by, on, or near children, or people with disabilities.
Chapter 1: Overview

1-2
Questions? Refer to Page 11-22 For Technical Support Instructions.
READTHIS BEFORE USINGTHE EQUIPMENT
• Do not place the equipment in liquid, nor put it where it could fall into liquid.
• Use the equipment only for the purpose described in the instructions for use.
• Do not use accessories which are not supplied or recommended by the manufacturer.
• Do not use the equipment if it is not working properly, or if it has suffered any damage.
NOTE: Examples of typical defects include:
 • damage caused by dropping the equipment;
 • damagecausedbydroppingtheequipmentintowaterorsplashingwaterontoit.
• Do not let the equipment come into contact with surfaces which are too hot to touch.
• Do not place anything on top of the equipment.
• Unless specifically instructed to do so by the instructions for use, do not drop or put anything into any opening in the
equipment.
• Do not use the equipment out of doors.
Chapter 1: Overview

1-3
Questions? Refer to Page 11-22 For Technical Support Instructions.
TrueID
Easy Data Entry Choose between the built-in barcode scanner, compatible with one dimensional (1D) and two
dimensional (2D) barcodes, and the alphanumeric keypad for entering data as required by point-
of-care policy. The meter can be configured to accept patient identification, operator identification,
test strip lot number, comment code, and up to two free text fields for other data such as physician
name.
Patient ID Confirmation The meter can display the patient name, date of birth and gender for confirmation, supporting
positive patient identification procedures. Entry of the year of birth also can be required for
confirmation.
Data Integrity Many options are available to help ensure that correct data is collected with each test, including:
specifying the minimum and maximum length of an ID, restricting the types of barcodes to be
accepted, using a check digit to verify the barcode, or requiring repeated entry of data on the
keypad if the barcode scanner is not used. The meter also records the method of patient and
operator identification data entry (scanned versus manually entered on the keypad) to help Point of
Care Coordinators identify and correct errors.
TrueMeasure
Fast, Simple Testing To perform a test, simply insert a strip into the meter’s port, apply a small drop of blood and wait
for the countdown to complete. For convenience, the sample may be applied to either the top or
end of the test strip. The test will not start until adequate sample has been applied. This safeguard is
designed to prevent errors, strip wastage and unnecessary repeat tests due to short-sampling.
Chapter 1: Overview