Operator’s Manual

for Healthcare Professionals

 Table of Contents
This Operator's Manual provides basic information about the FreeStyle Precision Pro system. It is organised into three
sections. The 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

Questions? Refer to Page 11-22 For Technical Support Instructions. i

 Table of Contents continued
Battery Compartment.........................................................................................................................................................................2-5
Strip Port Module................................................................................................................................................................................2-6
Optional Wireless Network Connection..........................................................................................................................................2-6
Meter Identification.............................................................................................................................................................................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

Questions? Refer to Page 11-22 For Technical Support Instructions. ii

 Table of Contents continued
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 Proficiency Data...................................................................................................................................................5-12
Data Review for Linearity Data.......................................................................................................................................................5-14
6. Proficiency Test.............................................................................................................................................................. 6
Proficiency Test - Glucose................................................................................................................................................................. 6-1
Proficiency Test - Ketone (Beta-Hydroxybutyrate)........................................................................................................................ 6-7
7. Linearity Test.................................................................................................................................................................. 7
8. Review Setup.................................................................................................................................................................. 8
Meter Configuration...........................................................................................................................................................................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

Questions? Refer to Page 11-22 For Technical Support Instructions. iii

 Table of Contents continued
9. Review Setup for Wireless Communication (Optional)............................................................................................... 9
Meter Wireless Configuration...........................................................................................................................................................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

Questions? Refer to Page 11-22 For Technical Support Instructions. iv

 Table of Contents continued
12. Maintenance................................................................................................................................................................. 12
Cleaning the Exterior Surface..........................................................................................................................................................12-1
Replacing the Strip Port Module.....................................................................................................................................................12-3
Replacing the Batteries.....................................................................................................................................................................12-5
13. Specifications............................................................................................................................................................... 13
FreeStyle Precision Pro Meter..........................................................................................................................................................13-1
Symbols...............................................................................................................................................................................................13-3
Barcode Types....................................................................................................................................................................................13-6

Questions? Refer to Page 11-22 For Technical Support Instructions. v

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

Intended Use
The 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 (fingertip), and of ketone (beta-
hydroxybutyrate) in fresh capillary whole blood samples. The FreeStyle Precision Pro system is for professional use. The system
is not for use in diagnosing diabetes mellitus, but is to be used as an aid in monitoring the effectiveness 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 after collection.
The FreeStyle Precision Pro system simplifies 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.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 1: Overview 1-1
READ THIS BEFORE USING THE 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.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 1: Overview 1-2
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.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 1: Overview 1-3
Automatic Calibration Scanning the barcode label on each test strip foil packet prior to use automatically calibrates the
meter and checks the expiry date, helping ensure reliable and accurate test results. Testing can also
be restricted to approved strip lots.
QC Lock-out The meter can be configured to require periodic testing using control solutions, and to lock out
access to the system if these tests are not completed. QC results can be displayed as pass/fail only,
preventing patient testing while in control test mode.

TrueAccess
Operator Management Access to the meter can be restricted to certified operators, locking out untrained users. A warning
can also be displayed to an operator whose ID is set to expire in the near future.
Results Storage The FreeStyle Precision Pro meter can store up to 2,500 patient test results and 1,000 control
test results, in addition to 20 proficiency test results and 2 linearity panels. All stored data can be
automatically uploaded to the data management system using the docking station (optional), a data
upload cable (optional), or wirelessly (optional) in a WiFi enabled facility when the meter and data
management systems are properly configured.
Network Connectivity FreeStyle Precision Pro meters can upload data via docking station, cable or wirelessly. The
uploaded data can then be configured via a central data management system, across the
organisation’s computer network. This provides a simple and automated way to manage multiple
instruments, meter point-of-care testing, and report test data to the Laboratory Information System
(LIS) or Hospital Information System (HIS) for inclusion in the patient's Electronic Medical Record
(EMR).

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 1: Overview 1-4
Results Transmission The FreeStyle Precision Pro meter allows results transmission via a docking station or upload
cable. If the agreement with Abbott Diabetes Care Inc. includes wireless functionality on the
FreeStyle Precision Pro system and both your data management system and individual meters are
enabled, data will be updated in real-time through your facility’s wireless network. For additional
information about the wireless option refer to the Wireless Set-Up Utility CD (optional).

Notes and Warnings

Information that is of particular relevance to the reader is called out in grey boxes throughout the manual, with an appropriate
icon and warning level.

IMPORTANT: Indicates that inconvenience to the operator or danger to the patient may result if the
instruction is not followed.

Note: Provides or refers the operator to additional or background information that may be helpful to them.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 1: Overview 1-5
Meter Display Icons
Your FreeStyle Precision Pro meter screen may reflect informational icons to indicate system status. Common icons and their
meaning are listed in the table below.
Icons Indication Explanation
For All Meters
Indicates current battery strength of the meter. A completely black
Battery Strength
battery symbol indicates full battery strength.
Progress Status Bar Indicates progress status of an active task such as a download.

For Wireless Enabled Meters Only (optional)

Indicates meter has stored test results that have not yet been transmitted
Data Pending Transmission
to the data management system.
Wireless Enabled Indicates the meter is enabled for wireless transmission.
Indicates active wireless data transmission. Note: The data transmission
Wireless Transmission
icon is animated.

Wireless Hardware Error Indicates a problem with the meter’s wireless hardware module.

Indicates strength of wireless signal. Five vertical bars indicate maximum

Signal Strength
signal strength.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 1: Overview 1-6
Conventions
The glucose unit of measure is set using the data management system. It is not changed via the meter menu. In this manual,
when a meter screen shot shows a glucose test result in one unit of measure (e.g. mmol/L) the equivalent value in the other unit
of measure (e.g. mg/dL) appears below the image. Ketone test results always appear in the mmol/L unit of measure.
  

100 mg/dL

IMPORTANT: Please confirm that the correct unit of measure shows on your meter with every
glucose result.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 1: Overview 1-7
System Components
The FreeStyle Precision Pro meter is part of an overall system designed to simplify point-of-care testing. These components are
purchased separately and some are optional.

FreeStyle Precision Pro System Components

The FreeStyle Precision Pro System includes the following items:
• Meter • Blood Glucose Test Strips • Control Solutions
Optional components for use with the FreeStyle Precision Pro System include:
• Blood Ketone Test Strips • Abbott Single Use Lancet
• Calibration Verification Controls • Docking Station
• FreeStyle Isolation Bags • Data Upload Cable
• Carry Case • Wireless Set-Up Utility CD
• FreeStyle Precision Pro Strip Port Module Replacement • Data Management System

IMPORTANT: Observe caution when using around children. Small parts may constitute a choking
hazard.

IMPORTANT: Use product and accessories only as directed. Failure to operate the product(s) in
accordance with the manufacturer’s documentation may impair product safety.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 1: Overview 1-8
Meter
The FreeStyle Precision Pro meter has many features designed to help simplify testing. It can be used with one hand, either
the left or the right. The display has large text and is backlit to make reading easy. The keypad is similar to a telephone and
each button clicks when pressed. Use of the meter is described in Chapters 2 to 9 of this Operator’s Manual and in the Quick
Reference Guide (available separately).
At the top of the meter is the test strip port module. The strip port Strip Port Module

module is designed to minimise liquid and other potential contaminants

Test Strip Port
entering the meter through the strip port (Chapter 12 provides
instructions for changing the strip port module). Underneath this is the Barcode
Scanner
window for the barcode scanner. On the back of the meter is the battery
compartment (Chapter 12 also provides instructions for changing the Display Serial
batteries). Just above the battery compartment is a label with the unique Number
Meter
serial number of the meter. A unique serial number label of the meter Identification
is inside the battery compartment. On the side of the meter is the meter Space
Battery
identification space. Keypad Compartment
(Serial Number
Label Inside)
Data Port

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 1: Overview 1-9
This untextured area (22 mm wide by 12 mm high) provides a space in which to apply a facility-specific location label. At the
bottom is the data port for connecting the meter to a data upload cable or docking station (Chapter 10 provides information on
uploading data to a data management system).
Each FreeStyle Precision Pro meter is shipped with this Operator’s Manual and two AA batteries.

IMPORTANT: Avoid getting dust, dirt, blood, control solution, water or any other substance in
the meter’s test strip port.

Test Strips
FreeStyle Precision Pro and Precision Xceed Pro Test Strips offer the latest advancements in biosensor technology. The test strips
work by first inserting the contact bars into the meter. Then the sample is applied to the target area, covering both the working
electrode and the reference electrode. This area is coated with active ingredients that react in the presence of glucose or ketone
to make a small electric current. This current is passed through the strip to the contact bars and the meter, which calculates a
glucose or ketone result.
FreeStyle Precision Pro and Precision Xceed Pro Blood Glucose Test Strips use proprietary glucose-specific chemistry that
includes the glucose dehydrogenase enzyme, NAD cofactor and PQ mediator (GDH-NAD). This chemistry is used for testing
glucose because it is not affected by maltose, icodextrin, and other common substances at elevated levels. It also ensures minimal
measurement bias from oxygen and haematocrit.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 1: Overview 1-10
FreeStyle Precision Pro Blood β-Ketone Test Strips and Precision Xceed Pro Blood β-Ketone
Test Strips are also available for use with the FreeStyle Precision Pro system. These test strips
have chemistry to specifically measure β-hydroxybutyrate, the primary ketone produced
when a patient is developing ketoacidosis.
Both glucose and ketone test strips also have exclusive blood application features to ensure
reliable sampling. First, the target area may be filled by applying a drop of sample to the top
of the test strip or by touching the end of the test strip to the sample. Second, the fill trigger Fill Trigger Electrode
electrode ensures that the test will only start once sufficient blood has been applied. Together, Working Electrode
Reference Electrode
these features minimise the possibility of errant results due to sample application technique.

IMPORTANT: Do not apply blood to the test strip when the test strip is out of the meter.
Do not use wet, bent, scratched or damaged test strips.

Each test strip is protected by a foil packet bearing an individual barcode label. The foil packet maintains the integrity of each
test strip by protecting it from exposure to air and moisture and accidental contamination. The barcode label holds information
about the test strip including the lot number, calibration, expiry date, and expected control solution ranges. One quick scan
provides the meter with all this information at the time of the test.

IMPORTANT: Do not scan a packet’s barcode and use a test strip from another packet. Use the test
strip immediately after opening its foil packet. Do not use the test strip if the foil packet
has a puncture or tear in it. Failure to follow instructions can cause incorrect results to
be generated.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 1: Overview 1-11
There are four types of test strips that may be used for testing with the FreeStyle Precision Pro system: the FreeStyle Precision Pro
Blood Glucose Test Strips and Precision Xceed Pro Blood Glucose Test Strips (blue foils) for testing glucose levels in fresh whole
blood, and the FreeStyle Precision Pro Blood β-Ketone Test Strips and Precision Xceed Pro Blood β-Ketone Test Strips (purple
foils) for testing ketone levels in fresh whole blood. Inside each box of test strips is a package insert with detailed instructions for
use.

FreeStyle Precision Pro Precision Xceed Pro Blood FreeStyle Precision Pro Precision Xceed Pro
Blood Glucose Test Strip Glucose Test Strip Blood β-Ketone Test Strip Blood β-Ketone Test Strip

ART21874 Rev. B

ART21875 Rev. B
EXP.
Glucose EXP.
β-Ketone

IMPORTANT: The FreeStyle Precision Pro system will only work with FreeStyle Precision Pro or
Precision Xceed Pro brand test strips. Use of any other test strips will cause erroneous
results.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 1: Overview 1-12
Control Solutions
Control solutions are used to perform regular quality control checks on the meter to ensure it is functioning correctly. Control
testing is further described in Chapter 4. Use MediSense Glucose and Ketone Control Solutions with the FreeStyle Precision Pro
system. These control solutions are available in one, two or three level configurations.
Calibration Verification Controls
Use RNA Medical brand Glucose and β-Ketone Calibration Verification Controls to confirm the calibration and analytical
measurement range of the meter for FreeStyle Precision Pro Blood Glucose or Blood β-Ketone Test Strips. This is called linearity
testing and requires a kit with 5 levels of control solution. Linearity testing is further described in Chapter 7.
Replacement Strip Port Module
A replacement strip port module is available if the system becomes disabled as a result of blood, fluid or other contaminant
entering the strip port. Repeated strip port error messages may also indicate the need for replacement. The strip port module
replacement procedure is described in Chapter 12.
Data Management System
Abbott’s FreeStyle PrecisionWeb Point-of-Care Health Management System (PrecisionWeb) is necessary to upload results from
the FreeStyle Precision Pro meter. Data upload from remote locations requires either terminal servers or networked PCs running
Abbott’s Data Repeater software. Data can also be uploaded through a wireless network when the individual meters and data
management system are properly enabled. Wireless configuration details are described in the optional Wireless Set-Up Utility
CD.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 1: Overview 1-13
FreeStyle Isolation Bag (optional)
FreeStyle Isolation Bags are disposable plastic bags for use with the FreeStyle Precision Pro system. The isolation bag provides a
partial barrier between the point-of-care monitoring device and the patients in isolation for infection control. There is no need
to prep the meter prior to using the bag and the bag does not affect any meter functions. The FreeStyle Precision Pro system is
only compatible with Abbott isolation bags (including the FreeStyle isolation bag). Other isolation bags can not be used with the
FreeStyle Precision Pro system. Note that Abbott isolation bags are not sterilised.
Carry Case (optional)
The carry case holds the meter, test strips, control solutions, the quick reference guide and other
accessories needed for testing. A transparent cover allows you to check supply status without
opening the case.

Docking Station (optional)

The docking station provides a convenient way to upload the data from the meter to the data
management system. When the meter is placed in the docking station, it will automatically upload data to
the data management system and then shut down. Docking the meter also allows you to complete software
upgrades with the PrecisionWeb data management system. Docking the meter for software upgrades is also
required for meters enabled for wireless data upload. Data upload is further described in Chapter 10.

Data Upload Cable (optional)

Alternatively, a data upload cable is available to connect the meter to the computer running the data management system.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 1: Overview 1-14
2. Using the Meter
Barcode Scanner
Data Entry Keypad
Audible Indicator
Data Port
Battery Compartment
Strip Port Module
Optional Wireless Network Connection
Meter Identification
Menu Tree
 Using the Meter

Barcode Scanner
The barcode scanner enables you to scan barcode information, using specified 1D and 2D barcode formats (please refer to
Chapter 13), into the meter instead of manually entering the data using the keypad. Scanning the barcode on the test strip foil
packet automatically enters the test strip information (calibration, control range, lot number and expiry date). The scanner may
also be used to enter Operator ID, Patient ID, control lot number and expiry date, comment code and free text fields. To operate
the meter:

Step 1: Hold the barcode scanner 6-18 cm (2.5-7 inches)

from the barcode to be scanned, and at a 50 to 130 degree
angle to the barcode.
Step 2: Press and hold down the Scan button until a visible 130° 50°

green beam is emitted by the meter.

Note: A scattered red light is emitted by the scanner along with the green beam for
illumination.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 2: Using the Meter 2-1
 Step 3: Slowly move the meter, if needed, so that the green beam is directly over the barcode.
Step 4: The meter will beep in acknowledgement when it accepts the barcode.

Note: If you hold the Scan button for three seconds, the scanner stops. Reposition scanner and try again.
Optimal distance depends on barcode type.

When first learning to use the barcode scanner, some precautions should be taken. It is important that you place the object to
be scanned on a flat surface or hold it by itself. This will prevent other items from being accidentally scanned.
If data has been manually entered, scanning data will erase the manually entered data (unless the Enter key has been selected to
confirm manual entry) and replace it with the scanned data. This entry will be considered scanned. Upon a successful barcode
scan, this system will automatically proceed to the next screen. The scanning beam shuts off in three seconds if nothing is
detected.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 2: Using the Meter 2-2
Data Entry Keypad
The data entry keypad allows you to enter identification numbers and letters (only the 26 letter
English alphabet) or to select an option that appears on the display. The keypad contains a 10 digit
telephone-style keypad with the keys for the numbers 0-9. The 2-9 keys also have letters printed
below the number. The keypad also has six special keys, including a Scan button, On/Off button,
Backlight/Alphanumeric, Clear, Menu and Enter keys.

Scan 
Press this button to operate the barcode scanner. If the audible indicator is enabled, the meter
will beep once a barcode has been successfully scanned. Continuing to hold the Scan button
will display the scanned barcode on the display until the button is released. If no information is
scanned after 3 seconds, the scanner will turn off.

On/Off 
Press this button to turn the meter on. Each time the meter is turned on, the Abbott logo screen will appear in black for a few
seconds and then will appear in grey. This provides an opportunity to ensure that all the pixels are working correctly.
Press and hold this button for 2 seconds to turn the meter off. The meter will automatically shut itself off after 4 minutes to
conserve battery life. The length of time for automatic shut-off can be configured from 4 to 10 minutes following patient tests
only.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 2: Using the Meter 2-3
Backlight/Alphanumeric 
Press and hold this button for about 2 seconds to activate the display backlight.
Press this button while manually entering data to toggle between numeric, uppercase alpha mode
and lowercase alpha mode during manual data entry. When in alpha mode, enter alpha characters
on the screen by pressing the 2 to 9 buttons multiple times to cycle through the characters. Enter a
SPACE character in alpha mode by pressing the 1 key.
The meter displays which mode you are in with a lowercase/uppercase alpha indicator in the lower right side of the display.

Clear 
Press this button to back up one space while entering alphanumeric information on the keypad.
This button is also used to return to a previous screen if necessary.

Menu 
Press this button to switch the meter from Test Mode to Menu Mode. These two modes are described in the next section. When
viewing configuration information in Menu Mode, pressing this button one time will return to the top of the menu tree. Pressing
the button a second time will switch to Test Mode.

Enter 
Press the Enter button after entering data on the keypad to proceed to the next screen.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 2: Using the Meter 2-4
Audible Indicator
The meter has an audible indicator that can be turned on or off. This indicator emits two tones, a high pitched tone to indicate
success and a low pitched tone to indicate a problem. If enabled, the meter will beep to indicate the following actions:
• The operator has successfully scanned a barcode;
• The meter has detected an adequate sample and is starting test analysis;
• The meter is nearing completion of test analysis (3 beeps with final countdown);
• The meter has displayed the test result;
• An error has occurred (see Chapter 11 for troubleshooting information);
• The meter will automatically shut off in thirty seconds (2 beeps);
• The operator has pressed an unexpected button;
• The operator has pressed the On/Off button.

Data Port
The data port is located at the bottom of the meter. This port enables the meter to automatically transfer the data through a cable
or docking station to the data management system. Data may be transferred through a cable or docking station even if the meter
is wireless enabled.

Battery Compartment
The meter holds two AA batteries to power the meter.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 2: Using the Meter 2-5
Strip Port Module
The strip port module should be replaced if the meter becomes disabled as a result of liquid or other contaminant entering the
strip port. Replacement is also indicated in the case of repeated strip port module errors. Chapter 12 provides instructions for
replacing the strip port module.

Optional Wireless Network Connection

If your agreement with Abbott Diabetes Care Inc. includes wireless functionality on the FreeStyle Precision Pro system and both
your data management system and individual meters are enabled, your system is capable of automatic and secure wireless data
transmission. The system uses wireless transmission with diversity to improve signal strength and transfer enabling wireless data
upload even in challenging RF environments. The meter has dual-band coverage which is compatible with IEEE 802.11/a/b/g
wireless (WiFi) bands. The optional wireless function must be configured in your data management system and enabled in each
meter by your system administrator. Wireless specifications are described in the Wireless Set-Up Utility CD (optional).
The Wireless Enabled icon (antenna) is displayed on the meter’s screen whenever the wireless function is enabled.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 2: Using the Meter 2-6
The 802.11a/b/g wireless radio technology in this product is in compliance with the Class B Information Technology Equipment
requirements and other relevant provisions of European Union Radio and Telecommunications Terminal Equipment Directive
1999/5/EC. The limits for Class B equipment were derived for typical residential environments to provide reasonable protection
against interference with licensed communications devices. The internal function is a radio device using the 2.4 GHz frequency
band (2.400GHz - 2.4845 GHz) and 5 GHz frequency band (5.150-5.250 GHz, 5.725-5.825 GHz). It is intended for wireless
communication with other 802.11a/b/g-enabled devices in an indoor environment.
The use of 802.11a/b/g wireless technology in certain countries may be restricted. Before using 802.11x products, please confirm
with the frequency management authority in the country where you plan to use it. Some countries allow indoor use only. In
some situations or environments, the use of 802.11x wireless technology might be restricted by the proprietor of the building or
responsible representatives of the organisation, for example, in aeroplanes, in hospitals or in any other environment where the
risk of interference with other devices or services is perceived or identified as harmful.
If you are uncertain of the policy that applies to the use in a specific organisation or environment, you are encouraged to ask
for authorisation to use 802.11x wireless technology prior to switching it on. Consult your physician or the manufacturer of
personal medical devices (pacemakers, hearing aids, etc.) regarding any restrictions on the use of 802.11x wireless technology.
Changes or modifications made in this device, which are not expressly approved by Abbott Diabetes Care Inc., could void the
user’s authority to operate the equipment.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 2: Using the Meter 2-7
Meter Identification
Each meter has a unique serial number. The FreeStyle Precision Pro meter also features an untextured area on the side of
the device. This 22 mm wide (0.875 inch) x 12 mm (0.483 inch) high area allows a facility to apply a label with information
pertaining to the meter. Please refer to Chapter 1 for an illustration of this feature.

Menu Tree
When using the FreeStyle Precision Pro meter you will navigate between two main menus, Test Mode and Menu Mode. Test
Mode is used to perform patient tests and control tests. Menu Mode is used to review data, perform linearity and proficiency
tests and review the meter’s configuration settings and status (e.g. battery voltage). The configuration options shown in Menu
Mode must be configured using a data management system and the Wireless Set-Up Utility (optional). You can visually verify
existing meter settings, but cannot change them.
The Menu Mode portion of the software is set up like a tree, with various levels of sub-menus. The FreeStyle Precision Pro Menu
Tree, shown below, illustrates the multiple sub-menu layers.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 2: Using the Meter 2-8
 Menu Tree
Test Mode Menu Mode
1. Patient Test 1. Data Review 1. Patient by OperID 4. Control Data
2. Patient by PatID 5. Proficiency Data
3. All Patient Data 6. Linearity Data
2. Control Test
Upload Interval
2. Review Setup 1. Test Setup 1. All Tests Operator ID
Operator ID Truncation
Operator ID Prompt
Glucose Units
2. Test Type Glucose Action Range
Glucose Critical Range
Ketone Action range
Ketone Critical Range
Patient ID
3. Patient Test Patient ID Truncation
Comment Code If In-Range
Comment Code If Out-of-Range
Patient ID Prompt
Repeat Manual ID Entry
Levels
4. Control Test Result
Comment Code If In-Range
Comment Code If Out-of-Range
QC Interval
5. Security Operator ID Not Certified
Strip Lot Not on List
Patient Data Not Confirmed

Questions? Refer to Page 11-22 For Technical Support Instructions.

Confirm Patient Data
Strip Port Quality Control Security

2. System Status
- Battery Power
3. Proficiency Test - Temperature
- Time
- Date
4. Linearity Test - Software Version
- Wireless Timeout

5. Wireless Menu 1. Enable/Disable

2. Network Server
Port
Timeout
DHCP
IP
MASK
GW
MAC

3. Signal Freq
RSS
SNR

4. Security SSID
Authentication
EAP
User Account
Chapter 2: Using the Meter
2-9
3. Patient Test
Operating Guidelines for All Samples
Collecting Blood Samples
How to Obtain a Capillary Blood Sample
(For Glucose or Ketone Testing)
How to Obtain a Venous Blood Sample
(For Glucose or Ketone Testing)
How to Obtain an Arterial Blood Sample
(For Glucose Testing)
How to Obtain a Neonatal Capillary Blood Heel Stick Sample (For Glucose Testing)
Disposing of Waste
Patient Test Procedure - FreeStyle Precision Pro Glucose
Patient Test Procedure - Precision Xceed Pro Glucose
Patient Test Procedure - Ketone
 Patient Test

This chapter describes the steps to be taken to test patient blood glucose or ketone levels in fresh whole blood using the FreeStyle
Precision Pro system. Inside each box of test strips is a package insert with detailed instructions for use.

Operating Guidelines for All Samples

Please follow the recommended guidelines for the most accurate results:
• Always wear gloves and follow your facility’s biohazard safety policies and procedures when performing tests involving
patient blood samples.
• Make sure that the meter and test strips are at room temperature. If the meter is moved to an area that is warmer or cooler
than where it was before, allow the meter to reach the new room temperature before testing.
• Use only control solutions specified in the test strip instructions for use to verify the performance of the FreeStyle Precision
Pro meter.
• Use FreeStyle Precision Pro and Precision Xceed Pro Test Strips with the FreeStyle Precision Pro meter.
• Refer to the test strip package insert for specific directions on storage and use of the test strips.
• Do not use the test strips beyond the expiry date printed on the barcode label and outer box.
• Do not use the test strip if the foil packet has a puncture or tear.
• Do not use test strips that are wet, bent, scratched or damaged. Use the test strip immediately after opening its foil packet.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 3: Patient Test 3-1
 • Do not use test strips if the strip port module is not fully inserted. User will receive an error message if the strip port
module is not secure.
• Use each test strip only once.
• Do not scan a test strip packet's barcode and then use a test strip from a different packet. This may cause inaccurate results.
• Apply a drop of blood to the target area at the end of the test strip. The test results will not be affected if the target area has
been briefly touched with the patient’s finger, a capillary tube, syringe, or pipette.
• After the blood is applied to the test strip and the test countdown begins, do not remove or disturb the test strip.

IMPORTANT: Do not allow blood or other solution to run down the test strip into the meter’s test strip
port. The strip port module should be replaced if the meter becomes disabled as a result
of liquid or other contaminants entering the strip port.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 3: Patient Test 3-2
Collecting Blood Samples
How to Obtain a Capillary Blood Sample (For Glucose or Ketone Testing):
• Only auto-disabling single use lancing devices should be used.
• Use a new pair of clean gloves for each patient.
• Use only fresh whole blood samples.
• Make sure that the sampling site is clean and dry before lancing.
• Collect the capillary blood using an auto-disabling, single use lancing device and an appropriate
technique.
• Apply a drop of blood to the target area at the end of the test strip.
• If necessary, blood can be collected in a capillary tube coated with heparin or EDTA, and then be
applied to the test strip within 30 minutes of collection. Mix the blood specimen well immediately
before applying the sample to the target area of the test strip.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 3: Patient Test 3-3
 How to Obtain a Venous Blood Sample (For Glucose or Ketone Testing):
• Use a new pair of clean gloves for each patient.
• Use only fresh whole blood samples.
• Collect the venous blood sample in a collection tube containing heparin or EDTA. Make sure that
the tube is filled to the stated volume. Do not under fill.
• Do not use collection tubes that contain fluoride or oxalate.
• If the blood is collected from an intravenous line, clear the line before drawing the sample into a
heparinised syringe.
• Use the sample within 30 minutes of collection.
• Invert the tube with the sample several times immediately before removing the sample.
• Use a disposable transfer pipette to obtain a sample from the centre of the collection tube.
• Apply a drop of blood to the target area at the end of the test strip.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 3: Patient Test 3-4
 How to Obtain an Arterial Blood Sample (For Glucose Testing):
• Use a new pair of clean gloves for each patient.
• Use only fresh whole blood samples.
• Clear the arterial line before drawing a blood sample into a heparinised syringe.
• Use the sample within 30 minutes of collection.
• Mix the blood specimen well immediately before applying the sample to the target area of the test
strip.
• Allow a drop of blood to form at the tip of the syringe.
• Apply a drop of blood to the target area at the end of the test strip.

How to Obtain a Neonatal Capillary Blood Heel Stick Sample (For Glucose Testing):
• Use a new pair of clean gloves for each patient.
• Use only fresh whole blood samples.
• Collect the capillary blood using an auto-disabling, single use lancing device and an appropriate
technique.
• Apply a drop of blood to the target area at the end of the test strip.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 3: Patient Test 3-5
 • The blood can be collected in a capillary tube coated with heparin, and then applied to the test
strip. Mix the blood specimen well immediately before applying the sample to the target area of the
test strip.
• Alternately, you can use the heel-to-strip method: Allow a hanging drop of blood to form from the
heel and apply to the target area of the test strip. Results will not be impacted by gently touching the
heel to the test strip.

Disposing of Waste
Observe the following guidelines when disposing of biohazardous waste:
• Dispose of used lancets in an approved sharps container.
• Discard used capillary tubes, disposable transfer pipettes or tips, used strip port modules and test
strips in an approved biohazard container.
• Follow your facility’s biohazard disposal policy.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 3: Patient Test 3-6
Patient Test Procedure - FreeStyle Precision Pro Glucose
Use the following procedure to perform a patient test using the FreeStyle Precision Pro Blood Glucose Test Strip.

Note: The following section illustrates some common settings. Depending on your facility’s specific settings,
some screens will display differently or not at all. If the meter does not display the screens shown,
please refer to Chapter 11, Troubleshooting.

What You See on the Display What You Do Comments

1. Press On/Off to turn on the meter. The Abbott logo screen will appear in
black for a few seconds and then will
appear in grey to ensure that the display is
functioning properly. Next, the software
version will briefly appear.

2. Press 1 to select Patient Test. The meter starts in Test Mode. The Menu
button will toggle the meter to Menu
Mode.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 3: Patient Test 3-7
 What You See on the Display What You Do Comments

3. Press Scan to scan the Operator ID While the Operator ID may be up to 30

barcode or manually enter the Operator digits, not all digits will fit on the display.
ID via the keypad, then press Enter. The meter may also be set to truncate
(ignore) leading, trailing, and/or selected
digits of the barcode.

4. Press Scan to scan the Patient ID While the Patient ID may be up to 30 digits,
barcode or manually enter the Patient not all digits will fit on the display. The
ID via the keypad (if enabled). meter may also be set to truncate (ignore)
selected digits of the barcode.

5. Confirm the Patient ID (if prompted). If you enter the ID manually, you may be
You may see one of the following four required to enter it a second time to ensure
screens: it is correct.
Re-enter the ID using the keypad.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 3: Patient Test 3-8
 What You See on the Display What You Do Comments

Press 2 to Confirm the Patient ID or 1 to

ReEnter the ID.

Enter the year of birth (e.g. enter “63” for Press Clear to re-enter the ID. If numbers
1963; enter “01” for 2001) then press the have been entered, the Clear key will erase
Enter button. those first. Multiple presses of the Clear key
may be required to return to the Patient ID
entry screen in step 4.

Press 2 to Continue testing or 1 to

ReEnter the ID.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 3: Patient Test 3-9
 What You See on the Display What You Do Comments

6. Press Scan to scan the test strip barcode Scanning the barcode identifies the strip
or manually enter the test strip lot type, calibrates the meter, ensures the
number via the keypad, then press expiry date has not passed, records the strip
Enter. lot used, and checks that the lot has been
approved for use by your facility.

7. The Sample Type screen will appear. Use Venous mode only for venous samples
You can select one of the following: that have been in capped tubes and that
Press 1 - Arterial/Capillary, or have not been mixed with air. Use Arterial/
Capillary mode for all other samples.
Press 2 - Venous.
If the Sample Type screen is not seen,
continue with step 8.
8. Make sure your hands or gloves are
clean and dry before opening the foil
packet. Open the foil test strip packet at
the notch and tear down to remove the
test strip.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 3: Patient Test 3-10
 What You See on the Display What You Do Comments

9.  With the contact bars facing up, insert Prior to inserting the test strip, ensure that
the test strip into the test strip port until the strip port module is installed and that it
it stops and Strip Inserted is displayed. is clean and dry. Replace if necessary. The
display will alternate between Insert Strip
and Glucose.

10.  When Apply Sample is displayed, apply When sufficient sample has been applied,
a drop of blood from the patient’s finger, the meter beeps, displays Sample
transfer pipette or syringe to the target Accepted and automatically starts the test.
area of the test strip. For a detailed description of the test strip
target area, refer to the Test Strips section of
Chapter 1.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 3: Patient Test 3-11
 What You See on the Display What You Do Comments

11. Wait for the meter to analyse the sample The meter counts down, then displays the
and display the test result. test result. If an error is detected during
the assay, the assay is terminated and no
result is displayed. Once the assay begins,
all key presses are ignored until the assay is
completed.

12. I f required, scan or manually enter the The meter may be enabled to scan or enter a
comment code and press Enter. 1- to 2-digit comment code.

If there is no prompt to enter a

comment code, skip down to step 13.

100 mg/dL
If prompted, scan or manually enter the free The meter may be enabled to scan or enter
text information and press Enter. the free text information. Up to two free text
fields may appear.

If there is no prompt to enter free text, skip

down to step 13.
100 mg/dL

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 3: Patient Test 3-12
 What You See on the Display What You Do Comments

For out-of-range results, refer to your Your facility may establish an Action
facility’s policy. Range. The meter will display results
outside of this range. A comment code may
be required for results outside the action
range.

288 mg/dL
Above Action Range

For out-of-range results, refer to your Your facility may establish a Critical
facility’s policy. Range. The meter will not display results
outside of this range. A comment code may
be required for results outside the critical
range.

>400 mg/dL
Above Critical Range

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 3: Patient Test 3-13
 What You See on the Display What You Do Comments

13. You can select one of the following The display shows:
options: Patient ID or Name (p: prompt)
Press 1–Next Patient. Comment Code (Number in box)
Press 2–Patient History. Date and Time of test
Press Menu to return to the Test Type (Glucose)
Menu Mode menu. If 1 is selected, the Scan Patient ID screen
100 mg/dL Press On/Off to turn off the meter. will appear. Return to step 4 to continue
Remove the test strip from the meter with testing on the next patient.
and discard it when finished testing. If 2 is selected, the meter will display the last
Follow your facility’s biohazard disposal test result for this patient as well as allow
policy. you to view previous results.
Refer to the section titled Data Review
for Patient by Patient ID in Chapter 5 for
IMPORTANT: further information.
I f the blood glucose result appears to be inconsistent (lower or higher than
expected), and you have ruled out common errors in technique, there may
be a problem with the test strip. Repeat the test using a new test strip.
Results that are incorrect may have serious medical consequences.
Consult the prescribing physician before making any changes to diabetes
medication plans.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 3: Patient Test 3-14
Patient Test Procedure - Precision Xceed Pro Glucose
Use the following procedure to perform a patient test using the Precision Xceed Pro Blood Glucose Test Strip.

Note: The following section illustrates some common settings. Depending on your facility’s specific settings,
some screens will display differently or not at all. If the meter does not display the screens shown,
please refer to Chapter 11, Troubleshooting.

What You See on the Display What You Do Comments

1. Press On/Off to turn on the meter. The Abbott logo screen will appear in
black for a few seconds and then will
appear in grey to ensure that the display is
functioning properly. Next, the software
version will briefly appear.

2. Press 1 to select Patient Test. The meter starts in Test Mode. The Menu
button will toggle the meter to Menu
Mode.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 3: Patient Test 3-15
 What You See on the Display What You Do Comments

3. Press Scan to scan the Operator ID While the Operator ID may be up to 30

barcode or manually enter the Operator digits, not all digits will fit on the display.
ID via the keypad, then press Enter. The meter may also be set to truncate
(ignore) leading, trailing, and/or selected
digits of the barcode.

4. Press Scan to scan the Patient ID While the Patient ID may be up to 30 digits,
barcode or manually enter the Patient not all digits will fit on the display. The
ID via the keypad (if enabled). meter may also be set to truncate (ignore)
selected digits of the barcode.

5. Confirm the Patient ID (if prompted). If you enter the ID manually, you may be
You may see one of the following four required to enter it a second time to ensure
screens: it is correct.
Re-enter the ID using the keypad.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 3: Patient Test 3-16
 What You See on the Display What You Do Comments

Press 2 to Confirm the Patient ID or 1 to

ReEnter the ID.

Enter the year of birth (e.g. enter “63” for Press Clear to re-enter the ID. If numbers
1963; enter “01” for 2001) then press the have been entered, the Clear key will erase
Enter button. those first. Multiple presses of the Clear key
may be required to return to the Patient ID
entry screen in step 4.

Press 2 to Continue testing or 1 to

ReEnter the ID.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 3: Patient Test 3-17
 What You See on the Display What You Do Comments

6. Press Scan to scan the test strip barcode Scanning the barcode identifies the strip
or manually enter the test strip lot type, calibrates the meter, ensures the
number via the keypad, then press expiry date has not passed, records the strip
Enter. lot used, and checks that the lot has been
approved for use by your facility.

7. Make sure your hands or gloves are

clean and dry before opening the foil
packet. Open the foil test strip packet at
the notch and tear down to remove the
test strip.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 3: Patient Test 3-18
 What You See on the Display What You Do Comments

8.  With the contact bars facing up, insert Prior to inserting the test strip, ensure that
the test strip into the test strip port until the strip port module is installed and that it
it stops and Strip Inserted is displayed. is clean and dry. Replace if necessary. The
display will alternate between Insert Strip
and Glucose.

9.  When Apply Sample is displayed, apply When sufficient sample has been applied,
a drop of blood from the patient’s finger, the meter beeps, displays Sample
transfer pipette or syringe to the target Accepted and automatically starts the test.
area of the test strip. For a detailed description of the test strip
target area, refer to the Test Strips section of
Chapter 1.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 3: Patient Test 3-19
 What You See on the Display What You Do Comments

10. Wait for the meter to analyse the sample The meter counts down, then displays the
and display the test result. test result. If an error is detected during
the assay, the assay is terminated and no
result is displayed. Once the assay begins,
all key presses are ignored until the assay is
completed.

11. I f required, scan or manually enter the The meter may be enabled to scan or enter a
comment code and press Enter. 1- to 2-digit comment code.
If there is no prompt to enter a
comment code, skip down to
step 12.

100 mg/dL

If prompted, scan or manually enter the free The meter may be enabled to scan or enter
text information and press Enter. the free text information. Up to two free text
If there is no prompt to enter free text, skip fields may appear.
down to step 12.

100 mg/dL

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 3: Patient Test 3-20
 What You See on the Display What You Do Comments

For out-of-range results, refer to your Your facility may establish an Action
facility's policy. Range. The meter will display results
outside of this range. A comment code may
be required for results outside the action
range.

288 mg/dL
Above Action Range

For out-of-range results, refer to your Your facility may establish a Critical
facility's policy. Range. The meter will not display results
outside of this range. A comment code may
be required for results outside the critical
range.

>400 mg/dL
Above Critical Range

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 3: Patient Test 3-21
 What You See on the Display What You Do Comments

12. You can select one of the following The display shows:
options: Patient ID or Name (p: prompt)
Press 1–Next Patient. Comment Code (Number in box)
Press 2–Patient History. Date and Time of test
Test Type (Glucose)
Press Menu to return to the
Menu Mode menu. If 1 is selected, the Scan Patient ID screen
100 mg/dL will appear. Return to step 4 to continue
Press On/Off to turn off the meter.
with testing on the next patient.
Remove the test strip from the meter
and discard it when finished testing. If 2 is selected, the meter will display the last
Follow your facility’s biohazard disposal test result for this patient as well as allow
policy. you to view previous results.
Refer to the section titled Data Review
for Patient by Patient ID in Chapter 5 for
further information.

IMPORTANT: If the blood glucose result appears to be inconsistent (lower or higher than expected),
and you have ruled out common errors in technique, there may be a problem with the
test strip. Repeat the test using a new test strip.
Results that are incorrect may have serious medical consequences. Consult the
prescribing physician before making any changes to diabetes medication plans.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 3: Patient Test 3-22
Patient Test Procedure - Ketone
Use the following procedure to perform patient tests with the FreeStyle Precision Pro Blood β-Ketone Test Strip and Precision
Xceed Pro Blood β-Ketone Test Strip. The FreeStyle Precision Pro meter recognises the type of test strip based on the scan of the
strip barcode.

Note: The following section illustrates some common settings. Depending on your facility’s specific settings,
some screens will display differently or not at all. If the meter does not display the screens shown,
please refer to Chapter 11, Troubleshooting.

What You See on the Display What You Do Comments

1.  Follow steps 1 to 7 in the last section Prior to inserting the test strip, ensure that
on the Glucose Patient Test. Insert the the strip port module is installed and that it
purple Blood β-Ketone Test Strip into is clean and dry. Replace if necessary. The
the test strip port until it stops and display will alternate between Insert Strip
Strip Inserted is displayed. The meter and Ketone.
will recognise the strip based on the
barcode.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 3: Patient Test 3-23
 What You See on the Display What You Do Comments

2.  When Apply Sample is displayed, When sufficient sample has been applied,
apply a drop of blood from the patient's the meter beeps, displays Sample
finger, transfer pipette or syringe to the Accepted and automatically starts the test.
target area of the test strip. For a detailed description of the test strip
target area, refer to the Test Strips section of
Chapter 1.

3.  Wait for the meter to analyse the sample The meter counts down then displays the
and display the test result. test result. If an error is detected during
the assay, the assay is terminated and no
result is displayed. Once the assay begins,
all key presses are ignored until the assay is
completed.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 3: Patient Test 3-24
 What You See on the Display What You Do Comments

4.  If prompted, scan or manually enter the The meter may be enabled to scan or enter a
comment code and press Enter. 1- to 2-digit comment code.
If there is no prompt to enter a The meter may display out-of-range results
comment code skip down to step 5. similar to those for Glucose if enabled for
ketone testing.
The meter may be also be enabled to scan or
enter up to two free text information fields.
5. You can select one of the following The display shows:
options: Patient ID or Name (p: prompt)
Press 1 – Next Patient. Comment Code (Number in box)
Press 2 – Patient History. Date and Time of test
Test Type (Ketone)
Press Menu to return to Menu Mode
menu. If 1 is selected, the Scan Patient ID screen
will appear. Continue with testing on the
Press On/Off to turn off the meter. next patient.
Remove the test strip from the meter If 2 is selected, the meter will display the last
and discard it when finished testing. test result for this patient as well as allow
Follow your facility’s biohazard disposal you to view previous results.
policy.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 3: Patient Test 3-25
4. Control Test
Operating Guidelines for Control Solution Testing
Control Test Procedure - Glucose
Control Test Procedure - Ketone
 Control Test

This chapter describes the steps for running a control test with control solutions. Control tests verify the performance of the
FreeStyle Precision Pro meter and test strips.
The quality control features of the meter can be customised to fit the requirements of each facility.
The meter can be set to require:
• Tests of low, mid, and high control solutions or a variation depending on the facility’s policy.
• Tests of control solutions at relative times (e.g. every 24 hours) or fixed times (e.g. at 6:00, 14:00, and 22:00).
• Tests of control solutions after strip port module replacement.
• Control test results to appear as numeric value or Pass/Fail.
These quality control features can be set through the data management system.

Operating Guidelines for Control Solution Testing

Observe the following guidelines to obtain optimal quality control results using the FreeStyle Precision Pro system:
• Use only MediSense Glucose and Ketone Control Solutions with compatible test strips to verify the performance of the
FreeStyle Precision Pro meter and test strips.
• When opening a new bottle, write the discard date on the bottle label. Each bottle of control solution is stable for 90 days
after opening or until the expiry date printed on the label, whichever comes first.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 4: Control Test 4-1
 • Do not use control solutions after the expiry date printed on the bottles and the box. After the bottle has been opened, do
not use after the discard date written on the bottle.
• Invert the control solution bottle several times to ensure thorough mixing before use.
• Invert and tap the capped control solution bottle to remove air bubbles from the tip of the bottle.
• Wipe the control solution nozzle with a clean gauze or tissue before and after each test.
• Do not scan one test strip foil packet’s barcode and use a test strip from another foil packet. This may cause incorrect results
to be generated.
• Replace the correct cap on the bottle and tighten the cap immediately after each use.
When To Test with Control Solutions
• As required by your facility’s quality policy or local regulatory requirements.
• To verify the performance of the FreeStyle Precision Pro system.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 4: Control Test 4-2
Workflow
The meter expects to run control tests in the following order. If a control level is disabled, the meter will expect to skip it. If
ketone testing is disabled, the operator will not receive a prompt to perform this test.

1. Low Glucose
2. Mid Glucose
3. High Glucose
4. Low Ketone
5. Mid Ketone
6. High Ketone

IMPORTANT: Do not allow control solution to drip down into meter port.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 4: Control Test 4-3
Control Test Procedure - Glucose
Use the following procedure to perform glucose control tests.

Note: The following section illustrates some common settings. Depending on your facility’s specific settings,
some screens will display differently or not at all. If the meter does not display the screens shown,
please refer to Chapter 11, Troubleshooting.

What You See on the Display What You Do Comments

1. Press On/Off to turn on the meter. The Abbott logo screen will appear in
black for a few seconds and then will
appear in grey to ensure that the display is
functioning properly. Next, the software
version will briefly appear.

2. Press 2 to select Control Test. The meter starts in Test Mode. The Menu
button will toggle the meter to Menu
Mode.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 4: Control Test 4-4
 What You See on the Display What You Do Comments

3. Press Scan to scan the Operator ID While the Operator ID may be up to 30

barcode or manually enter the Operator digits, not all digits will fit on the display.
ID via the keypad, then press Enter. The meter may also be set to truncate
(ignore) leading, trailing, and/or selected
digits of the barcode.

4. Scan or manually enter the low control You can scan or manually enter the
solution lot number via the keypad, information from the control solution’s
then press Enter. barcode. For manual entry, key in the five
numeric digits of the lot number printed on
the control solution bottle. You do not need
to enter the alpha character that appears at
the end of the 5-digit number. The Strip Lot
screen will appear next.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 4: Control Test 4-5
 What You See on the Display What You Do Comments

If the Unexpected Level screen appears, The meter is programmed to expect Low,
you may either: Mid, and High Glucose, then Low, Mid, and
1. Enter 1 to ReEnter the expected level. High Ketone control tests in this order. A
warning message will appear if the controls
2. Enter 2 to Continue. are used in a different order, however you
may still proceed with the test.

5.  Press Scan to scan the test strip barcode Scanning the barcode identifies the strip
or manually enter the test strip lot type, calibrates the meter, ensures the
number via the keypad, then press expiry date has not passed, records the strip
Enter. lot used, programs control solution range
and checks that the lot has been approved
for use by your facility.

Note: Place meter on a flat surface while running control tests to prevent
control solution from dripping into the test strip port.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 4: Control Test 4-6
 What You See on the Display What You Do Comments

6.  Make sure your hands or gloves are

clean and dry before opening the foil
packet. Open the foil test strip packet at
the notch and tear down to remove the
test strip.

7.  With the contact bars facing up, insert Prior to inserting the test strip, ensure that
the test strip into the test strip port until the strip port module is installed and that it
it stops and Strip Inserted is displayed. is clean and dry. Replace if necessary. The
display will alternate between Insert Strip
and Glucose.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 4: Control Test 4-7
 What You See on the Display What You Do Comments

8.  Gently invert the required control When sufficient sample has been applied,
solution bottle 3-4 times. Remove the the meter beeps, displays Sample
cap of the control solution bottle and Accepted and automatically starts the test.
wipe the nozzle with a clean gauze or For a detailed description of the test strip
tissue. Apply a small drop of solution target area, refer to the Test Strips section of
to the test strip target area. Wipe the Chapter 1.
nozzle of the control solution bottle
before replacing the cap.

Note: Do not lift the meter to view the display until after the test strip has been removed. Tipping the meter
while the test strip is inserted may cause the control solution to drip into the strip port, contaminating
the strip port. If the meter becomes disabled as a result of liquid or other contaminants entering the
strip port, the strip port module should be replaced.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 4: Control Test 4-8
 What You See on the Display What You Do Comments

9.  Wait for the meter to analyse the sample The meter counts down then displays the
and display the test result. test result. If an error is detected during
When using FreeStyle Precision Pro the assay, the assay is terminated and no
test strips the countdown will begin at 5 result is displayed. Once the assay begins,
seconds. When using Precision Xceed all key presses are ignored until the assay is
Pro test strips the countdown will begin completed.
at 20 seconds.

10. Note the test result and whether it falls Control test results can appear as numeric
within the acceptable range. or PASS/FAIL, depending on how the test
If required, scan or manually enter the is set up. If numeric, an “X” will appear in
comment code and press Enter. front of a test result that is out-of-range.

If there is no prompt to enter a The meter may be enabled to scan or enter a

comment code skip down to step 11. 1- to 2-digit comment code.
92 mg/dL

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 4: Control Test 4-9
 What You See on the Display What You Do Comments

11.  You may select one of the following: The display shows:
Press 1 – Next Level. Level (Low, Mid, High)
Press 2 – Repeat Test. Comment Code (Number in box)
Test Type (Glucose)
Press Menu to return to the Date and Time of test
Menu Mode menu. Operator ID (o: prompt)
Press On/Off to turn off the meter. Note that test date and time alternates with

Remove the test strip from the meter Operator ID.
and discard it when finished testing. If 1 is selected, the Scan or Enter Control
Follow your facility’s waste disposal Lot screen will appear. Return to step 4 to
policy. perform the Next Level control test.
If 2 is selected, the Scan or Enter Strip
Lot screen will appear. Return to step 5 to
Repeat Test at the same level.

Note: If ketone testing is disabled, then following a complete set of Glucose controls, 1-Next Level becomes
1-Exit.
If ketone testing is enabled and Glucose QC is run first, then following a complete set of Glucose
controls, 1-Next Level becomes 1-QC Ketone.
If ketone testing is enabled and Ketone QC is run first, then following a complete set of ketone controls,
1-Next Level becomes 1-QC Glucose.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 4: Control Test 4-10
Control Test Procedure - Ketone
Use the following procedure to perform ketone control tests if ketone testing is enabled.

Note: The following section illustrates some common settings. If the meter does not display the screens
shown, please refer to Chapter 11, Troubleshooting.

What You See on the Display What You Do Comments

1.  Repeat steps 1 to 6 from the previous Prior to inserting the test strip, ensure that
Glucose Control Test Procedure. Insert the strip port module is installed and that it
the purple Blood β-Ketone Test Strip is clean and dry. Replace if necessary. The
into the test strip port until it stops and display will alternate between Insert Strip
Strip Inserted is displayed. The meter and Ketone.
will recognise the strip based on the
barcode.
2.  Gently invert the required control When sufficient sample has been applied,
solution bottle 3-4 times. Remove the the meter beeps, displays Sample
cap of the control solution bottle and Accepted and automatically starts the
wipe the nozzle with a clean gauze or test. For a detailed description of the test
tissue. Apply a small drop of solution to strip target area, refer to the Test Strips
the test strip target area. Wipe the nozzle section of Chapter 1.
of the control solution bottle before
replacing the cap.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 4: Control Test 4-11
 What You See on the Display What You Do Comments

3.  Wait for the meter to analyse the sample The meter counts down then displays the
and display the test result. test result. If an error is detected during
the assay, the assay is terminated and no
result is displayed. Once the assay begins,
all key presses are ignored until the assay is
completed.

4. Note the test result and whether it falls Control test results can appear as numeric or
within the acceptable range. PASS/FAIL, depending on how the test is set
If required, scan or manually enter the up. If numeric, an "X" will appear in front of a
comment code and press Enter. If there test result that is out-of-range.
is no prompt to enter a comment code The meter may be enabled to scan or enter a
skip down to step 5. 1- to 2-digit comment code.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 4: Control Test 4-12
 What You See on the Display What You Do Comments

5. You may select one of the following: The display shows:

Press 1 – Next Level. Level (Low, Mid, High)
Press 2 – Repeat Test. Comment Code (Number in box)
Test Type (Ketone)
Press Menu to return to the Menu Date and Time of test
Mode menu. Operator ID (o: prompt)
Press On/Off to turn off the meter. Note that test date and time alternates with
Remove the test strip from the meter Operator ID.
and discard it when finished testing. If 1 is selected, the Scan or Enter Control
Follow your facility’s waste disposal Lot screen will appear. Return to step 1 to
policy. perform the Next Level of control test.
If 2 is selected, the Scan or Enter Strip Lot
screen will appear. Repeat the test.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 4: Control Test 4-13
5. Data Review
Data Review for Patient by Operator ID
Data Review for Patient by Patient ID
Data Review for All Patient Data
Data Review for Control Data
Data Review for Proficiency Data
Data Review for Linearity Data
 Data Review

The FreeStyle Precision Pro meter stores the results of up to 2,500 patient tests, 1,000 control tests, 20 proficiency tests and 2
linearity panels. This data can be retrieved by the following categories:
Patient by Operator ID (OperID): This will show test results performed by a particular operator, starting with the most
recent test.
Patient by Patient ID (PatID): This will show test results performed for particular patient, starting with the most
recent test.
All Patient Data: This will display the test results for all patients, starting with the most recent test.
Control Data: This will show control test results, starting with the most recent test.
Proficiency Data: This will show proficiency test results, starting with the most recent test.
Linearity Data: This will show linearity test results, by level and order.

Note: The meter may be configured to require a valid Operator ID to view results. Once authenticated, the
Operator ID will not be displayed on each data review screen.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 5: Data Review 5-1
Follow these steps to access the Data Review menu:

Note: The following section illustrates some common settings. Depending on your facility’s specific settings,
some screens will display differently or not at all. If the meter does not display the screens shown,
please refer to Chapter 11, Troubleshooting.

What You See on the Display What You Do Comments

1.  Press the On/Off button to turn the The Abbott logo screen will appear in
meter on. black for a few seconds and then will
appear in grey to ensure that the display is
functioning properly. Next, the software
version will briefly appear.

2. Press the Menu button. The meter starts in Test Mode. The Menu
button will toggle the meter to Menu
Mode.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 5: Data Review 5-2
 What You See on the Display What You Do Comments

3. Press 1 to select Data Review.

4.  Press Scan to scan the Operator ID While the Operator ID may be up to 30

barcode or manually enter the Operator digits, not all digits will fit on the display.
ID via the keypad, then press Enter. The meter may also be set to truncate
(ignore) leading, trailing, and/or selected
digits of the barcode.

5.  Choose the category of data to review.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 5: Data Review 5-3
Data Review for Patient by Operator ID
Please refer to the beginning of this Data Review chapter for step-by-step instructions to access the Data Review menu.

Note: The following section illustrates some common settings. Depending on your facility’s specific settings,
some screens will display differently or not at all. If the meter does not display the screens shown,
please refer to Chapter 11, Troubleshooting.

What You See on the Display What You Do Comments

1.  Press 1 to select Patient by OperID. The meter shows the result of the most
recent patient test you performed.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 5: Data Review 5-4
 What You See on the Display What You Do Comments

2.  You can select one of the following The number that appears to the right of
options: 1-Previous and 2-Next on the meter
Press 1–Previous indicates the number of tests available for
review. The display also shows:
Press 2–Next
Patient ID or Name (p: prompt)
Selection 2-Next will be displayed only Comment Code (Number in box)
when there is new data for review. Test Type (Glucose or Ketone)
100 mg/dL Operator ID (o: prompt)
When finished reviewing the data, you
can: Date and Time of test
Press Clear to return to the Note that test date and time alternates with
Data Review menu. Operator ID.
Press Menu to return to the
Menu Mode menu.
Press On/Off to turn off the meter.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 5: Data Review 5-5
Data Review for Patient by Patient ID
Please refer to the beginning of this Data Review chapter for step-by-step instructions to access the Data Review menu.

Note: The following section illustrates some common settings. Depending on your facility’s specific settings,
some screens will display differently or not at all. If the meter does not display the screens shown,
please refer to Chapter 11, Troubleshooting.

What You See on the Display What You Do Comments

1.  Press 2 to select Patient by PatID. The meter shows test results for a specific
patient.

2.  Press Scan to scan the Patient ID If you enter the ID manually, you may be
barcode or manually enter the Patient required to enter it a second time to ensure
ID via the keypad (if enabled). it is correct.
While the Patient ID may be up to 30 digits,
not all digits will fit on the display. The
meter may also be set to truncate (ignore)
selected digits of the barcode.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 5: Data Review 5-6
 What You See on the Display What You Do Comments

3.  You can select one of the following The number that appears to the right of
options: 1-Previous and 2-Next on the meter
Press 1–Previous indicates the number of tests available for
review. The display also shows:
Press 2–Next
Patient ID or Name (p: prompt)
Selection 2-Next will be displayed only Comment Code (Number in box)
when there is new data for review. Test Type (Glucose or Ketone)
100 mg/dL Operator ID (o: prompt)
When finished reviewing the data, you
can: Date and Time of test
Press Clear to return to the Note that test date and time alternates with
Patient ID entry screen. Operator ID.
Press Menu to return to the
Menu Mode menu.
Press On/Off to turn off the meter.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 5: Data Review 5-7
Data Review for All Patient Data
Please refer to the beginning of this Data Review chapter for step-by-step instructions to access the Data Review menu.

Note: The following section illustrates some common settings. Depending on your facility’s specific settings,
some screens will display differently or not at all. If the meter does not display the screens shown,
please refer to Chapter 11, Troubleshooting.

What You See on the Display What You Do Comments

1.  Press 3 to select All Patient Data. The meter will show all patient test results,
starting with the most recent results.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 5: Data Review 5-8
 What You See on the Display What You Do Comments

2. You can select one of the following The number that appears to the right of
options: 1-Previous and 2-Next on the meter
Press 1–Previous indicates the number of tests available for
review. The display also shows:
Press 2–Next
Patient ID or Name (p: prompt)
Selection 2-Next will be displayed only Comment Code (Number in box)
when there is new data for review. Test Type (Glucose or Ketone)
100 mg/dL Operator ID (o: prompt)
When finished reviewing the data,
you can: Date and Time of test
Press Clear to return to the Note that test date and time alternates with
Data Review screen. Operator ID.
Press Menu to return to the
Menu Mode menu.
Press On/Off to turn off the meter.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 5: Data Review 5-9
Data Review for Control Data
The meter stores the last 1,000 control test results. Please refer to the beginning of this Data Review chapter for step-by-step
instructions to access the Data Review menu.

Note: The following section illustrates some common settings. Depending on your facility’s specific settings,
some screens will display differently or not at all. If the meter does not display the screens shown,
please refer to Chapter 11, Troubleshooting.

What You See on the Display What You Do Comments

1.  Press 4 to select Control Data. The meter shows the result of the most recent
control test.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 5: Data Review 5-10
 What You See on the Display What You Do Comments

2. You can select one of the following The number that appears to the right of
options: 1-Previous and 2-Next on the meter
Press 1–Previous indicates the number of tests available
for review. The display also shows the
Press 2–Next acceptable range for this test and:
Selection 2-Next will be displayed only Comment Code (Number in box)
when there is new data for review. Level (low, mid, high)
When finished reviewing the data, Range (if numeric)
you can: Test Type (Glucose or Ketone)
Operator ID (o: prompt)
Press Clear to return to the Date and Time of test
Data Review screen.
Press Menu to return to the Note that test date and time alternates with
Menu Mode menu. Operator ID.
Press On/Off to turn off the meter.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 5: Data Review 5-11
Data Review for Proficiency Data
The meter stores the last 20 proficiency test results. Please refer to the beginning of this Data Review chapter for step-by-step
instructions to access the Data Review menu.

Note: The following section illustrates some common settings. Depending on your facility’s specific settings,
some screens will display differently or not at all. If the meter does not display the screens shown,
please refer to Chapter 11, Troubleshooting.

What You See on the Display What You Do Comments

1.  Press 5 to select Proficiency Data. The meter shows the most recent
proficiency test result.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 5: Data Review 5-12
 What You See on the Display What You Do Comments

2. You can select one of the following The number that appears to the right of
options: 1-Previous and 2-Next on the meter
Press 1–Previous indicates the number of tests available for
review. The display also shows:
Press 2–Next
Sample ID (s: prompt)
Selection 2-Next will be displayed only Comment Code (Number in box)
when there is new data for review. Test Type (Glucose or Ketone)
100 mg/dL Operator ID (o: prompt)
When finished reviewing the data,
you can: Date and Time of test
Press Clear to return to the Note that test date and time alternates with
Data Review screen. Operator ID.
Press Menu to return to the
Menu Mode menu.
Press On/Off to turn off the meter.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 5: Data Review 5-13
Data Review for Linearity Data
The meter stores the last linearity panel that includes a maximum of 4 replicates for 5 levels (20 tests). Please refer to the
beginning of this Data Review chapter for step-by-step instructions to access the Data Review menu.

Note: The following section illustrates some common settings. Depending on your facility’s specific settings,
some screens will display differently or not at all. If the meter does not display the screens shown,
please refer to Chapter 11, Troubleshooting.

What You See on the Display What You Do Comments

1.  Press 6 to select Linearity Data. The meter shows linearity tests first by level
(1, 2, 3, 4, 5) then by order within each level.
If no tests are stored for a level, then that
level is skipped. At the top of the display, the
level (1 to 5) and test replicate (1 to 4) are
displayed.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 5: Data Review 5-14
 What You See on the Display What You Do Comments

2. You can select one of the following The number that appears to the right of
options: 1-Previous and 2-Next on the meter
Press 1–Previous indicates the number of tests available for
review. The display also shows:
Press 2–Next
Level (1 to 5), Test replicate (1 to 4)
Selection 2-Next will be displayed only Comment Code (Number in box)
when there is new data for review. Test Type (Glucose or Ketone)
100 mg/dL Operator ID (o: prompt)
When finished reviewing the data,
you can: Date and Time of test
Press Clear to return to the Note that test date and time alternates with
Data Review screen. Operator ID.
Press Menu to return to the
Menu Mode menu.
Press On/Off to turn off the meter.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 5: Data Review 5-15
6. Proficiency Test
Proficiency Test - Glucose
Proficiency Test - Ketone (Beta-Hydroxybutyrate)
 Proficiency Test

Proficiency Test - Glucose

Please use the following procedures to perform a proficiency test. The Proficiency Test menu enables you to perform unknown
sample test challenges if required by your facility's policy. This functionality may or may not be available depending on the
configuration of the meter through the data management system.

Note: The following section illustrates some common settings. Depending on your facility’s specific settings,
some screens will display differently or not at all. If the meter does not display the screens shown,
please refer to Chapter 11, Troubleshooting.

IMPORTANT: Patient testing should be run in patient test mode only.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 6: Proficiency Test 6-1
 What You See on the Display What You Do Comments

1.  Press the On/Off button to turn on the The Abbott logo screen will appear in
meter. black for a few seconds and then will
appear in grey to ensure that the display is
functioning properly. Next, the software
version will briefly appear.

2. Press the Menu button. The meter starts in Test Mode. The Menu
button will toggle the meter to Menu
Mode.

3.  Press 3 to select Proficiency Test.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 6: Proficiency Test 6-2
 What You See on the Display What You Do Comments

4.  Press Scan to scan the Operator ID While the Operator ID may be up to 30

barcode or manually enter the Operator digits, not all digits will fit on the display.
ID via the keypad, then press Enter. The meter may also be set to truncate
(ignore) leading, trailing, and/or selected
digits of the barcode.

5.  Scan or manually enter the Sample ID The meter will prompt for the Sample ID
via the keypad, then press Enter. to be scanned or entered. PROF indicates
proficiency test.

6.  Press Scan to scan the test strip barcode Scanning the barcode identifies the strip
or manually enter the test strip lot type, calibrates the meter, ensures the
number via the keypad, then press expiry date has not passed, records the strip
Enter. lot used, and checks that the lot has been
approved for use by your facility.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 6: Proficiency Test 6-3
 What You See on the Display What You Do Comments

7.  Make sure your hands or gloves are

clean and dry before opening the foil
packet. Open the foil test strip packet at
the notch and tear down to remove the
test strip.

8. With the contact bars facing up, insert Prior to inserting the test strip, ensure that
the test strip into the test strip port until the strip port module is installed and that
it stops and Strip Inserted is displayed. it is clean and dry. Replace if necessary. The
display will alternate between Insert Strip
and Glucose.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 6: Proficiency Test 6-4
 What You See on the Display What You Do Comments

9.  Ensure proficiency survey specimens When sufficient sample has been applied,
are at room temperature. Mix each the meter beeps, displays Sample
specimen well according to instructions Accepted and automatically starts the test.
from the survey provider. Wipe away For a detailed description of the test strip
any specimen on the tip of the vial target area, refer to the Test Strips section of
before squeezing the vial and applying Chapter 1.
a drop to the test strip target area. After
applying the sample, recap the vial
tightly.

10.  Wait for the meter to analyse the sample The meter counts down then displays the
and display the test result. test result. If an error is detected during
When using FreeStyle Precision Pro the assay, the assay is terminated and no
test strips the countdown will begin at 5 result is displayed. Once the assay begins,
seconds. When using Precision Xceed all key presses are ignored until the assay is
Pro test strips the countdown will begin completed.
at 20 seconds.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 6: Proficiency Test 6-5
 What You See on the Display What You Do Comments

11. If required, scan or manually enter the If the comment code option is enabled in
comment code and press Enter. the patient test configuration through the
 If there is no prompt to enter a data management system, the meter will
comment code, skip down to step 12. be enabled to scan or enter a 1 or 2 digit
comment code.

100 mg/dL

12.  You can select one of the following The display shows:
options: Sample ID (s: prompt)
Press 1 – Next Test. Comment Code (Number in box)
Press Menu to return to the Menu Test Type (Glucose)
Mode. Date and Time of test
Operator ID (o: prompt)
Press On/Off to turn off the meter.
100 mg/dL Note that test date and time alternates with
Remove the test strip from the meter Operator ID.
and discard it when finished testing.
Follow your facility’s biohazard disposal If 1 is selected, the Scan or Enter Sample
policy. ID screen will appear. Return to step 5
to perform the Next Test with another
proficiency sample.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 6: Proficiency Test 6-6
Proficiency Test - Ketone (Beta-Hydroxybutyrate)
Please use the following procedures to perform a ketone proficiency test.

What You See on the Display What You Do Comments

1. Follow steps 1 to 8 in the last section on Prior to inserting the test strip, ensure that
the Glucose Proficiency Test. Make sure the strip port module is installed and that it
you use the purple Blood β-Ketone Test is clean and dry. Replace if necessary. The
Strip for the blood Ketone Proficiency display will alternate between Insert Strip
Test. The meter will recognise the strip and Ketone.
based on the barcode.

2.  Ensure proficiency survey specimens When sufficient sample has been applied,
are at room temperature. Mix each the meter beeps, displays Sample
specimen well according to instructions Accepted and automatically starts the test.
from the survey provider. Wipe away For a detailed description of the test strip
any specimen on the tip of the vial before target area, refer to the Test Strips section of
squeezing the vial and applying a drop to Chapter 1.
the test strip target area. After applying
the sample, recap the vial tightly.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 6: Proficiency Test 6-7
 What You See on the Display What You Do Comments

3.  Wait for the meter to analyse the sample The meter counts down then displays the
and display the test result. test result. If an error is detected during
the assay, the assay is terminated and no
result is displayed. Once the assay begins,
all key presses are ignored until the assay is
completed.

4.  If required, scan or manually enter the If the comment code option is enabled in
comment code and press Enter. If there the patient test configuration through the
is no prompt to enter a comment code, data management system, the meter will
skip down to step 5. be enabled to scan or enter a 1 or 2 digit
comment code.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 6: Proficiency Test 6-8
 What You See on the Display What You Do Comments

5. You can select one of the following The display shows:

options: Sample ID (s: prompt)
Press 1 – Next Test. Comment Code (Number in box)
Press Menu to return to Menu Mode Test Type (Ketone)
menu. Date and Time of test
Operator ID (o: prompt)
Press On/Off to turn off the meter.
Note that test date and time alternates with
Remove the test strip from the meter Operator ID.
and discard it when finished testing.
Follow your facility’s biohazard disposal If 1 is selected, the Scan or Enter Sample
policy. ID screen will appear. Return to step 1
to perform the Next Test with another
proficiency sample.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 6: Proficiency Test 6-9
7. Linearity Test
 Linearity Test
®
The Linearity Test menu enables you to verify method linearity using an RNA Medical brand Calibration Verification Control
(CVC) kit. These kits contain assayed materials for use in confirming the calibration and linearity of glucose and ketone at the
upper and lower limits of the reportable range and at three (3) points within the range. CVC kits are designed for specific test
strip types. Please refer to the CVC package insert for compatible test strip types and detailed instructions for use.
Please use the following procedure to perform a Linearity Test. This functionality may or may not be available depending on the
configuration of the meter through the data management system.

Note: This section is only for Point-of-Care Coordinators, not operators. It illustrates some common settings.
Depending on your facility’s specific settings, some screens will display differently or not at all. If the
meter does not display the screens shown, please refer to Chapter 11, Troubleshooting.

IMPORTANT: Patient testing should be run in Patient Test mode only. Results obtained in Linearity
Test mode should only be used to assess system linearity performance.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 7: Linearity Test 7-1
 What You See on the Display What You Do Comments

1.  Press On/Off to turn on meter. The Abbott logo screen will appear in
black for a few seconds and then will
appear in grey to ensure that the display is
functioning properly. Next, the software
version will briefly appear.

2. Press the Menu button. The meter starts in Test Mode. The Menu
button will toggle the meter to Menu
Mode.

3.  Press 4 to select Linearity Test.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 7: Linearity Test 7-2
 What You See on the Display What You Do Comments

4.  Press Scan or manually enter the While the Operator ID may be up to 30

Operator ID via the keypad, then press digits, not all digits will fit on the display.
Enter. The meter may also be set to truncate
(ignore) leading, trailing, and/or selected
digits of the barcode.

Note: You must use the same strip lot for the entire panel when performing a Linearity Test.

5.  Select appropriate Linearity Panel. If ketone testing is disabled, this screen will
not appear.

6.  Scan or manually enter the CVC kit LIN stands for Linearity.
lot number via the keypad, then press
Enter.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 7: Linearity Test 7-3
 What You See on the Display What You Do Comments

7. If the New Panel screen appears you If the CVC kit lot number that was entered
may either: is different from the previous one, the meter
Press 1 – ReEnter Kit Lot. will prompt you to do one of two actions:

Press 2 – Replace Panel. Either re-enter the existing lot number or

replace the existing lot number with the
new lot number.

8.  Select the number of the level of the There can be up to 4 replicates per level.
next test to be run. If you press 6 for a The number in the parentheses indicates
New Panel, the meter will prompt you the number of replicates already run for
to confirm that you wish to replace the that level. When a level is full, the number 4
existing panel. will appear in parentheses, indicating that
all 4 replicates have been completed for this
level. For example 1 - Level 1 (4).

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 7: Linearity Test 7-4
 What You See on the Display What You Do Comments

9.  Press Scan to scan the test strip barcode Scanning the barcode identifies the strip
or manually enter the test strip lot type, calibrates the meter, ensures the
number via the keypad, then press expiry date has not passed, records the strip
Enter. lot used, and checks that the lot has been
approved for use by your facility.

10.  Make sure your hands or gloves are

clean and dry before opening the foil
packet. Open the foil test strip packet at
the notch and tear down to remove the
test strip.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 7: Linearity Test 7-5
 What You See on the Display What You Do Comments

11. With the contact bars facing up, insert Prior to inserting the test strip, ensure that
the test strip into the test strip port until the strip port module is installed and that it
it stops and Strip Inserted is displayed. is clean and dry. Replace if necessary. The
meter will prompt you to apply the sample
to the test strip.

12. Follow the instructions in the CVC kit When sufficient sample has been applied,
package insert. Then apply a drop of the the meter beeps, displays Sample
sample to the target area. Accepted and automatically starts the test.
For a detailed description of the test strip
target area, refer to the Test Strips section of
Chapter 1.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 7: Linearity Test 7-6
 What You See on the Display What You Do Comments

13. Wait for the meter to analyse the sample The meter counts down then displays the
and display the test result. test result. If an error is detected during
When using FreeStyle Precision Pro the assay, the assay is terminated and no
test strips the countdown will begin at 5 result is displayed. Once the assay begins,
seconds. When using Precision Xceed all key presses are ignored until the assay is
Pro test strips the countdown will begin completed.
at 20 seconds.

14.  Note the result. If required, scan or If the comment code option is enabled in
manually enter the comment code and the control test configuration through the
press Enter. data management system, the meter will
If there is no prompt to enter a be enabled to scan or enter a 1 or 2 digit
comment code, skip down to step 15. comment code.

100 mg/dL

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 7: Linearity Test 7-7
 What You See on the Display What You Do Comments

15.  You can select one of the following The display shows:
options: Level (Test level 1 to 5)
Press 1–New Level. Test (Replicate 1 to 4 for that level)
Press 2–Same Level. Comment Code (Number in box)
Test Type (Glucose)
Press the Menu button to return to the Date and Time of test
Menu Mode. Operator ID (o: prompt)
100 mg/dL
Press On/Off to turn off meter. Note that test date and time alternates with
Remove the test strip from the meter Operator ID.
and discard it when finished testing. If 2 is selected, the Scan or Enter Strip
Follow your facility’s biohazard disposal Lot screen will appear. Return to step 8 to
policy. continue linearity testing with the Same
Level.
If 1 is selected, the Select Level screen will
appear. Return to step 7 to perform linearity
tests for a New Level.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 7: Linearity Test 7-8
8. Review Setup
Meter Configuration
Review Setup
Review Test Setup for All Tests
Review Test Setup for Test Type
Review Test Setup for Patient Test
Review Test Setup for Control Test
Review Test Setup for Security
System Status
 Review Setup

Meter Configuration
The FreeStyle Precision Pro meter configuration settings are enabled via the data management system. These settings can be
viewed on the hand-held device, but cannot be changed on it. Settings that are configured through the data management system
are:

Upload Interval
• Length of time between data uploads.
• Whether you can continue to test (“allow test” or “warn”) or not (“lockout”).

Note: Wireless enabled systems will transfer data automatically without user interaction. Non-wireless enabled
systems will require the user to utilise the docking station or cable to transfer data at specified intervals.

Operator ID
• Whether the Operator ID is required, optional, or not used for all tests.
• Define the Operator ID prompt.
• The minimum and maximum number (between 1 and 30) of digits that are acceptable for the Operator ID.
• With manual entry of the Operator ID, determine whether a check digit is required (modulus 10 or 11).

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 8: Review Setup 8-1
 • Decide acceptable formats for the Operator ID barcode. Refer to the Barcode Types in Chapter 13 for available formats.
• The meter can truncate (ignore) the leading digits and/or the last digits of an Operator ID. The meter can be set to select
specific digits of an Operator ID. The number of digits is configured in the data management system.
Patient Tests / Patient ID
• Determine whether the Patient ID is required, optional, or not used for patient tests.
• Define the Patient ID prompt.
• The minimum and maximum number (between 1 and 30) of digits that are acceptable for the Patient ID.
• Permission for manual entry of the Patient ID.
• Determine whether duplicate entry of a manually entered ID is required.
• With manual entry of the Patient ID, determine whether a check digit is required (modulus 10 or 11).
• Decide acceptable formats for the Patient ID barcode. Refer to the Barcode Types in Chapter 13 for available formats.
• The meter can truncate (ignore) the leading digits and/or the last digits of a Patient ID. The meter can be set to select
specific digits of a Patient ID. The number of digits is configured in the data management system.
• Decide whether confirmation of the Patient ID is required.
• Determine how the ID will be confirmed.
• Decide whether to display Patient DOB on Patient ID prompt screen.
• Decide whether comment code is required, optional, or not used for patient tests that are in the acceptable range for the
facility and the test strip.
• Decide whether comment code is required, optional, or not used for patient tests that are outside of the acceptable range for
the facility and the test strip.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 8: Review Setup 8-2
Control Tests
• Set which levels of control solution are required, optional or not used by your facility. The meter can be configured to run
any combination of low, mid and high control solution tests.
• Set whether control solution test results display as numeric or as Pass/Fail.
• Determine whether a comment code is required, optional or not used for control tests that are within the acceptable range
for the facility and the test strip.
• Decide whether a comment code is required, optional or not used for control tests that are outside of the acceptable range
for the facility and the test strip.
QC Interval
• Determine how frequently QC tests need to be run. This can be set to a number of hours or up to three specified times
during the day.
• Decide whether the operator can continue to test (“allow test” or “warn”) or not (“lockout”) when the QC interval is
expired.
• Decide whether the operator can continue to test (“allow test” or “warn”) or not (“lockout”) immediately following strip
port module replacement.
Operator ID
• Decide whether an operator can continue to test (“allow test” or “warn”) or not (“lockout”) when the Operator ID has
expired.
• Decide the number of days before the Operator ID is set to expire that the operator will see a notification on the meter.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 8: Review Setup 8-3
Strip Lot
• Decide whether an operator can continue to test (“allow test” or “warn”) or not (“lockout”) when a strip lot is scanned or
entered to the meter for a lot of strips that is not on the approved strip lot list. The maximum number of strip lots that can
be downloaded to the FreeStyle Precision Pro meter is 36: 18 Glucose and 18 Ketone.
Other
• Decide what additional information to download to a meter through the data management system: lists of operators, lists
of strip lots, or lists of patients.
• Determine whether the meter displays results in mmol/L or mg/dL (Glucose only).
• Decide whether any additional free text comments are stored with a test record. These can be required, optional or not
used.
• Decide whether to configure the meter for proficiency tests.
• Decide whether to configure the meter for linearity tests.
• Determine what language (such as English) displays on the meter.
• Turn the audible indicator off/on.
• Determine whether to use alkaline, lithium or rechargeable batteries in the meter.
• Decide how soon the meter automatically turns off (4 - 10 minutes) after a patient test.
• Decide whether to enable ketone testing.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 8: Review Setup 8-4
 • Date display configuration on the meter. The date can be configured to the following formats:
• mm/dd/yy
• dd/mm/yy
• dd-mm-yy
• mm-dd-yy
• Time display configuration on the meter. The time can be configured to the following formats:
• hh:mm AM/PM
• h:mm AM/PM
• AM/PM h:mm
• hh:mm (24 hour)
Action Range/Critical Range
• Decide whether to set an action range, and what the range will be.
• Decide whether to set a critical range, and what the range will be.

Wireless Settings (for wireless enabled systems only /optional)

• Decide the wireless time-out interval. Decide the number of seconds of inactivity allowed before the meter reverts to
wireless standby to save battery power (wireless time-out interval).

The following features are configured through the optional Wireless Set-Up Utility CD only. Configuration can not be changed
through the data management system. Feature status can be viewed on the FreeStyle Precision Pro meter.
• View wireless network server information
• View signal strength and frequency information
• View wireless security information

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 8: Review Setup 8-5
Review Setup
Note: This section illustrates some representative settings.
If the meter does not display these screens, please refer to Chapter 11, Troubleshooting.

What You See on the Display What You Do Comments

1.  Press On/Off to turn on the meter. The Abbott logo screen will appear in
black for a few seconds and then will
appear in grey to ensure that the display is
functioning properly. Next, the software
version will briefly appear.

2. Press the Menu button. The meter starts in Test Mode. The Menu
button will toggle the meter to Menu
Mode.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 8: Review Setup 8-6
 What You See on the Display What You Do Comments

3.  Press 2 to select Review Setup.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 8: Review Setup 8-7
Review Test Setup for All Tests
Note: This section illustrates some representative settings.
If the meter does not display these screens, please refer to Chapter 11, Troubleshooting.

What You See on the Display What You Do Comments

1. Press 1 for Test Setup.

2. Press 1 for All Tests to continue to the

All Tests Upload Interval screen.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 8: Review Setup 8-8
 What You See on the Display What You Do Comments

3.  Press 1-Next to continue to the All

Tests Operator ID screen.

4.  Press 1-Next to continue to the All

Tests Operator ID Truncation
screen.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 8: Review Setup 8-9
 What You See on the Display What You Do Comments

5.  Press 1-Next to continue to the All

Tests Operator ID Prompt screen.

6.  Press 1-Next to return to the

Test Setup menu.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 8: Review Setup 8-10
Review Test Setup for Test Type

Note: This section illustrates some representative settings.

If the meter does not display these screens, please refer to Chapter 11, Troubleshooting.

What You See on the Display What You Do Comments

1. Press 1 for Test Setup.

2.  Press 2 for Test Type to continue to the

Test Type Glucose Units screen.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 8: Review Setup 8-11
 What You See on the Display What You Do Comments

3.  Press 1-Next to continue to the Test

Type Glucose Action Range screen.

4.  Press 1-Next to continue to the Test

Type Glucose Critical Range screen.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 8: Review Setup 8-12
 What You See on the Display What You Do Comments

5. If Ketone testing is enabled, press

1-Next to continue to the Test Type
Ketone Action Range screen,
otherwise, press 1-Next to continue to
the Test Setup menu.

6.  Press 1-Next to continue to the Test

Type Ketone Critical Range screen.

7.  Press 1-Next to continue to the Test

Setup menu.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 8: Review Setup 8-13
Review Test Setup for Patient Test
Note: This section illustrates some representative settings.
If the meter does not display these screens, please refer to Chapter 11, Troubleshooting.

What You See on the Display What You Do Comments

1. Press 1 for Test Setup.

2.  Press 3 for Patient Test to continue to

the Patient Test Patient ID screen.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 8: Review Setup 8-14
 What You See on the Display What You Do Comments

3.  Press 1-Next to continue to the Patient

Test Patient ID Truncation screen.

4.  Press 1-Next to continue to the Patient

Test Comment Code If In-Range
screen.

5.  Press 1-Next to continue to the Patient

Test Comment Code If Out-of-Range
screen.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 8: Review Setup 8-15
 What You See on the Display What You Do Comments

6.  Press 1-Next to continue to the Patient

Test Patient ID Prompt screen.

7.  Press 1-Next to continue to the Patient

Test Repeat Manual ID Entry screen.

8.  Press 1-Next to return to the Test

Setup menu.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 8: Review Setup 8-16
Review Test Setup for Control Test

Note: This section illustrates some representative settings.

If the meter does not display these screens, please refer to Chapter 11, Troubleshooting.

What You See on the Display What You Do Comments

1. Press 1 for Test Setup.

2.  Press 4 for Control Test to continue

to the Control Test Glucose Levels
screen.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 8: Review Setup 8-17
 What You See on the Display What You Do Comments

3.  Press 1-Next to continue to the Control

Test Glucose Result screen.

4.  If Ketone testing is enabled, press

1-Next to continue to the Control Test
Ketone Levels screen, otherwise, press
1-Next to skip down to step 7.

5.  Press 1-Next to continue to the Control

Test Ketone Result screen.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 8: Review Setup 8-18
 What You See on the Display What You Do Comments

6.  Press 1-Next to continue to the Control

Test Comment Code If In-Range
screen

7.  Press 1-Next to continue to the Control

Test Comment Code If Out-of-Range
screen.

8. Press 1-Next to return to the Test

Setup menu.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 8: Review Setup 8-19
Review Test Setup for Security

Note: This section illustrates some representative settings.

If the meter does not display these screens, please refer to Chapter 11, Troubleshooting.

What You See on the Display What You Do Comments

1. Press 1 for Test Setup.

2.  Press 5 for Security to continue to the

Security Glucose QC Interval screen.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 8: Review Setup 8-20
 What You See on the Display What You Do Comments

3.  If Ketone testing is enabled, press

1-Next to continue to the Security
Ketone QC Interval screen, otherwise,
press 1-Next to skip down to step 5.

4.  Press 1-Next to continue to the

Security Operator ID Not Certified
screen.

5.  Press 1-Next to continue to the

Security Strip Lot Not on List screen.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 8: Review Setup 8-21
 What You See on the Display What You Do Comments

6.  Press 1-Next to continue to the

Security Patient Data Not
Confirmed screen.

7.  Press 1-Next to continue to the

Security Confirm Patient Data
screen.

8.  Press 1-Next to continue to the Strip

Port Quality screen

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 8: Review Setup 8-22
 What You See on the Display What You Do Comments

9.  Press 1-Next to return to the Test

Setup screen

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 8: Review Setup 8-23
System Status

Note: This section illustrates some representative settings.

If the meter does not display these screens, please refer to Chapter 11, Troubleshooting.

What You See on the Display What You Do Comments

1.  Press On/Off to turn on the meter. The Abbott logo screen will appear in
black for a few seconds and then will
appear in grey to ensure that the display is
functioning properly. Next, the software
version will briefly appear.

2. Press the Menu button. The meter starts in Test Mode. The Menu
button will toggle the meter to Menu
Mode.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 8: Review Setup 8-24
 What You See on the Display What You Do Comments

3.  Press 2 to select Review Setup.

4.  Press 2 to continue to the System

Status Battery Power screen.

5.  Press 1-Next to continue to the System

Status Temperature screen.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 8: Review Setup 8-25
 What You See on the Display What You Do Comments

6.  Press 1-Next to continue to the System

Status Time screen.

7.  Press 1-Next to continue to the

System Status Date screen.

8.  Press 1-Next to continue to the

System Status Software Version
and Serial Number screen.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 8: Review Setup 8-26
 What You See on the Display What You Do Comments

9.  Press 1-Next to continue to the The number that appears on your meter
Wireless Communication Timeout may be different from the number that
Menu (optional). appears here.

10. Press 1-Next to return to the Review

Setup screen.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 8: Review Setup 8-27
9. Review Setup for Wireless
Communication (Optional)
Meter Wireless Configuration
 Review Setup for Wireless Communication (Optional)

Meter Wireless Configuration

The FreeStyle Precision Pro meter wireless configuration settings are enabled via the Wireless Set-up Utility (optional). These
settings can be viewed on the hand-held device, but cannot be changed on it except for the Enable/Disable meter wireless
module. Reference the Wireless Setup Utility User’s Guide for the instructions to activate, configure and enable the wireless
module for individual FreeStyle Precision Pro meters.

Note: This section illustrates some representative settings. If the meter does not display these screens, please
refer to Chapter 11, Troubleshooting.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 9: Review Setup for Wireless Communication (Optional) 9-1
 What You See on the Display What You Do Comments

1. Press 5 for Wireless Menu. is displayed when the meter is wireless

enabled.
is displayed when there is stored data in
the meter pending transmission.

2. Press 1 to disable the meter wireless Screen displays the wireless and network
function. information menu. Press 2 for network
setting, press 3 for wireless signal status and
press 4 for wireless security settings.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 9: Review Setup for Wireless Communication (Optional) 9-2
 What You See on the Display What You Do Comments

3. Press 2 for additional network settings. Screen displays the wireless network
settings configured through the Wireless
Set-Up Utility CD. The timeout interval is
set through the data management system.
This value indicates that the meter will
go into wireless stand-by mode to save
energy. Wireless stand-by mode is when the
meter requests a wireless communication
to server and receives no response in 60
seconds.
Reference the Wireless Set-Up Utility user
guide for more detailed information about
the other network settings.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 9: Review Setup for Wireless Communication (Optional) 9-3
 What You See on the Display What You Do Comments

4. Signal status screen. Screen displays the wireless band frequency

(Freq), the received signal strength (RSS)
and the signal noise ratio (SNR) at the time
of the last wireless transmission. Press 1
to refresh the screen for the current signal
status.

5. Security settings screen. Screen displays the security settings

configured through the Wireless Set-Up
Utility CD. If there are additional security
settings, press 1 to go to the next screen.

6. Press 1-Next to continue to the

Wireless Menu screen.

Note: For information on wireless data transfer see the Wireless Transfer
section in the Data Upload chapter.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 9: Review Setup for Wireless Communication (Optional) 9-4
10. Data Upload
Docking Station Upload
Wireless Transfer (if enabled)
Docking Station
Mounting Instructions
Enabling Data Upload
 Data Upload

Once the test results have been collected they can be uploaded into the data management system. Data may be uploaded
remotely utilising the docking station or through use of the optional wireless function if the data management system and meters
are properly enabled. The data management system provides a simple and automated way to collect, report and transfer data.

Docking Station Upload

To start the upload of data, simply place the FreeStyle Precision Pro meter into the docking station. The meter will first turn on if
it isn't already, and then automatically upload data to the data management system.

During communications, the Data Uploading screen appears and the arrows rotate to indicate
that the system is working. The arrows may occasionally pause. During data upload, the meter
cannot be used for testing.
After upload is complete, the meter will display Upload Successful,
Turning Off and then shut down.

Note: If the meter is removed before data transmission is complete, some data may not be uploaded. The
data will be uploaded as part of the next data transmission.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 10: Data Upload 10-1
If a problem occurs with the data upload, an error message may appear on the meter. If the meter is removed from the docking
station while an upload is in process, the meter will display Last upload incomplete, Redock meter, Turning Off. The meter
will then shut down. Error messages are shown in Chapter 11, Troubleshooting. Further troubleshooting information for any
data upload question is provided in the data management user manual.
After a data upload error has occurred, the meter will display a warning each time it is turned on.
The meter may still be used for testing by pressing 1 to Continue. Once the meter has
successfully been docked, the warning will disappear.

Wireless Transfer (if enabled)

If the data management system and meters are properly configured and the wireless function is enabled, data will be uploaded
automatically once the user leaves the test results screen. Active transmission is verifiable via the wireless transmission icon.
Wireless Enabled Icon The meter screen will display the Wireless Enabled icon when the wireless function is
enabled. After each test is performed, the data is stored in the meter database. Wireless
enabled meters will automatically establish communication and transfer stored meter data
wirelessly to the PrecisionWeb data management system. The meter’s wireless module
automatically reverts to power-saving standby mode when not actively transferring data.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 10: Data Upload 10-2
 Wireless Hardware Error The Wireless Hardware Error icon will be displayed when there is a failure of wireless
hardware module. Turn the meter off and back on again to re-establish wireless
connectivity. If the problem persists, contact your local Abbott Diabetes Care Inc. office or
distributor.
The following applies if the optional Wireless Communication is enabled:
When the meter turns off with test results still pending to send (Data Transmission
Pending), it will automatically attempt to send those results. This will occur when the meter
is turned off by pressing and holding the power button for 2 seconds or if it shuts itself off
automatically. The Data Uploading screen shown here will display until the meter completes
transferring pending results and then it will power off automatically. The Operator does
not need to take any action for this to occur. While Data Uploading screen is displayed,
the Operator can turn the meter off immediately by pressing ‘1 - Turn Off ’. If the Operator
does press ‘1 - Turn Off ’, wireless communication will stop and pending results will not be
transmitted. Pending results will be transferred the next time the meter establishes wireless
communication or the meter is docked, whichever comes first.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 10: Data Upload 10-3
Docking Station
The FreeStyle Precision Pro System offers a docking station that provides means for hands-free,
automatic data transfer (upload/download) between the FreeStyle Precision Pro meter and a PC
running the data management application software.
Set up the docking station outside patient vicinity. The docking station has a hinged base that allows it
to sit on a desktop or to be mounted to a wall using the included mounting plate.

Mounting Instructions
The docking station may be mounted vertically if desired. This operation is similar to
mounting a telephone on the wall.

Instructions:
1. Drill the holes to match to the wall mount.
2. Place the wall mount on the wall and insert the four enclosed screws.
3. Align the two holes in the docking station with the two mounting anchors.
4. After aligning the holes, press in and then down to secure the docking station.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 10: Data Upload 10-4
Enabling Data Upload
Data Upload Using Docking Station
The docking station has a data transfer port located on the back. The data transfer port connects the docking station to a
variety of transfer options using the included serial cable.
A connection to the data management system may be established directly, via a networked computer or via a terminal server.
These connections are illustrated in Figures 1 and 2.

Serial Cable

Figure 1
Figure 1 - Data Upload via Direct Connection or Networked Computer
1. Connect the serial cable between the docking station data transfer port and the computer.
2. Ensure that the computer has power, and if desired, a working network connection.
3. Ensure that the local data management system or Abbott Data Repeater (for a networked connection) is operational and
correctly configured. This software and its installation instructions are available separately.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 10: Data Upload 10-5
Figure 2 - Data Upload via Terminal Server AC Adapter
1. Connect the terminal server AC adapter to a power source.
Data Networking Cable
2. Connect the serial cable to the terminal server and to the docking
station data transfer port. Alternatively, connect the data upload cable
to the terminal server and to the data port of the FreeStyle Precision
Pro meter.
Terminal Server
3. Connect the data networking cable to the terminal server and the
network jack.

Figure 2 Data Upload Cable

Note: F or plug-connected equipment where protective earthing is required, plug the equipment into a
supply outlet that has a earth connection.

Data Upload Using Wireless

The optional wireless function allows for automatic data upload throughout a WiFi enabled facility when both the data
management system and meters are properly configured. Wireless function set-up is described in the Wireless Set-Up Utility CD
(optional).

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 10: Data Upload 10-6
11. Troubleshooting
Troubleshooting Patient Test Results
Troubleshooting Out-of-Range Control Test Results
Troubleshooting Out-of-Range Linearity Test Results
Troubleshooting Wireless (if enabled)
Troubleshooting Barcode Scanning
Error Messages
Technical Support Instructions
Returning a Meter
Contacting Abbott for Service
 Troubleshooting

Troubleshooting Patient Test Results

This section describes conditions that can cause erroneous patient test results. Refer to the test strip package insert for
specifications and detailed instructions for use.

Reasons Glucose Results May Be Higher Than Expected:

• Haematocrit is lower than the acceptable limit for the test strips, as indicated on test strip package insert.
• Serum or plasma samples were used instead of whole blood.
• Venous blood is tested in arterial/capillary mode when using FreeStyle Precision Pro test strips.
Reasons Glucose Results May Be Lower Than Expected:
• Haematocrit is higher than the acceptable limit for the test strips, as indicated on test strip package insert.
• Hyperglycaemic-hyperosmolar state (with or without ketosis).
• Severe dehydration, hypotension or shock.
• Water or alcohol remaining on the puncture site.
• Venous or arterial whole blood sample not tested within 30 minutes after collection.
• Arterial or capillary blood is tested in venous mode when using FreeStyle Precision Pro test strips.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 11: Troubleshooting 11-1
Reasons Ketone Results May Be Higher Than Expected:
• Haematocrit is lower than the acceptable limit for the test strips, as indicated on test strip package insert.
• Serum or plasma samples were used instead of whole blood.
Reasons Ketone Results May Be Lower Than Expected:
• Haematocrit is higher than the acceptable limit for the test strips, as indicated on test strip package insert.
• Water or alcohol remaining on the puncture site.
If test results appear higher or lower than expected for reasons not described above, please repeat the test using a new test strip.
If the results still appear higher or lower than expected, contact your local Abbott Diabetes Care Inc. office or distributor.

Troubleshooting Out-of-Range Control Test Results

Repeat the test for that control solution and make sure that the operator meets the conditions in this checklist:
• Eliminate any air bubbles in the control bottle’s tip.
• Wipe the control solution nozzle with a clean gauze or tissue before and after each test. Liquid left on the tip from previous
tests may have a glucose or ketone concentration higher than expected.
• Calibrate the meter using the barcode for the test strip used.
• Scan or enter the correct 5-digit lot number for the control solutions.
• Confirm that control solutions and test strips have been stored within the ranges specified on their respective cartons and
package inserts.
• Check that the temperature conditions in the room where the tests are being performed are within the acceptable
operating range as specified in the test strip package insert.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 11: Troubleshooting 11-2
 • Check that the bottles of control solutions have not been open for more than 90 days and are within the manufacturer’s
expiry date.
• Use a new test strip for each test.
• Use only FreeStyle Precision Pro compatible test strips.
• Use only MediSense Control Solutions.
• Confirm that the control solution tested (low, mid, or high) matches the level requested on the display.
If test results are out-of-range despite meeting the above criteria, please repeat the test using a new box of control solutions and/
or test strips. If the results are still out-of-range, contact your local Abbott Diabetes Care Inc. office or distributor.

Troubleshooting Out-of-Range Linearity Test Results

Repeat the test for that linearity level and make sure that the operator meets the conditions in this checklist:
• Use only the RNA Medical® brand Calibration Verification Control (CVC) kit that is compatible with the type of test strip
being used. Please refer to the package insert in the CVC kit for compatible test strip types and detailed instructions for use.
• Eliminate any air bubbles in the CVC bottle’s tip.
• Calibrate the meter using the barcode for the test strip used.
• Confirm that CVC solutions and test strips have been stored within the ranges specified on their respective cartons and
package inserts. Ensure the vials have come to room temperature and are properly mixed.
• Check that the temperature conditions in the room where the tests are being performed are within the acceptable operating
ranges as specified in the respective test strip and CVC kit package inserts.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 11: Troubleshooting 11-3
 • Check CVC bottle for open bottle expiry date.
• Use a new test strip for each test.
• Use only FreeStyle Precision Pro compatible test strips.
• Confirm that the CVC solution tested (level 1 - 5) matches the level requested on the display.
If test results are out-of-range despite meeting the above criteria, please repeat the test using a new CVC kit and/or test strips. If
the results are still out-of-range, contact your local Abbott Diabetes Care Inc. office or distributor.

Troubleshooting Wireless (if enabled)

You may verify wireless signal strength through the meter’s wireless menu. Turn your meter off then on again if you experience
any of the following:
• Your meter screen does not display the Wireless Enabled icon.
• Your meter screen does not display the Wireless Transmission icon, or the Wireless Hardware Error icon is displayed.
• Data is not correctly uploaded to the data management system.
If the problem persists, contact your system administrator to verify proper configurations. Specifications for the wireless function
are described in the Wireless Set-Up Utility CD (optional).

Troubleshooting Barcode Scanning

If you are using an Abbott isolation bag, it must be pulled taut over the meter’s barcode scan window for proper scanning.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 11: Troubleshooting 11-4
Error Messages
In this section, you will find information relating to error messages that appear on the display when the FreeStyle Precision Pro
meter detects errors.
For each corresponding message, an explanation is given and appropriate responses are described. In many situations, it may be
possible to proceed with some of the functions, at least temporarily, before attending to the problem. (For example, when the
batteries are too low to permit testing, it may be possible to review data for a short time.)
If any problem persists, record the error message displayed, which may include a 4-digit error code, and contact your local
Abbott Diabetes Care Inc. office or distributor.

When You Turn on the Meter, or During Use:

Symptom/Error Message Explanation How To Respond

The meter has little or no power. Verify proper battery installation.

If the problem persists, install new batteries.
See Chapter 12, Maintenance, for more
information.

The display is blank.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 11: Troubleshooting 11-5
 Symptom/Error Message Explanation How To Respond

Battery power is getting low. Testing will be Install new batteries. See Chapter 12,
available for a limited time. Maintenance, for more information.
Press 1 to turn meter off.

The strip port module is not detected by the Re-install strip port module.
meter. If problem persists, replace with a new strip
port module.
See Chapter 12, Maintenance, for more
information.

The strip port module has malfunctioned. Replace with a new strip port module.
See Chapter 12, Maintenance, for more
information.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 11: Troubleshooting 11-6
 Symptom/Error Message Explanation How To Respond

Occurs when any test is selected and the Press 1 to Exit. Turn meter off. Allow the
temperature is outside the meter operating meter to return to room temperature.
temperature range.

The meter is shipped from the factory Use PrecisionWeb or other Abbott-supplied
without configuration. This screen will software to configure the device to your
appear the first time you turn on the meter specific facility’s requirement prior to using
after receiving it. the device.

An error has occurred during last data Place the meter into the docking station to
transfer. This screen will appear when you complete the upload. Once the meter has
turn on the meter. successfully been docked, the warning will
disappear.
Or,
Press 1 to Continue testing.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 11: Troubleshooting 11-7
 Symptom/Error Message Explanation How To Respond

Meter Error The meter may have a problem that 1. Turn off the meter. Turn it on and repeat
prevents it from operating properly. One the function.
of several 4-digit error codes may be
n n n n 2. If the problem persists, place the meter
displayed. These codes provide Abbott in the docking station to update the
additional information about the problem. configuration files.
1-Turn Off
3. If the problem still persists, record the
4-digit error code and contact Abbott
Technical Support.

The test strip was inserted at the wrong Remove the test strip from the test strip
time. The meter will beep if functions are port.
attempted before the strip is removed or if
the test strip is left in when the test calls for
the test strip to be removed.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 11: Troubleshooting 11-8
 Symptom/Error Message Explanation How To Respond

The strip inserted is a Glucose strip, while 1. Press 1.

the meter was expecting a Ketone strip. 2. Remove test strip.
3. Insert new test strip.

If glucose QC is due soon, the message 1. If “Glucose QC Due in xx min.”

“Glucose QC Due in xx min." will is displayed, no action is required.
display on the main screen. The xx is the Glucose testing can proceed.
countdown to expiry. If glucose QC is due 2. If “Glucose QC Due Now” is displayed,
now, the message “Glucose QC Due Now” then Glucose QC testing per your
will display on the main screen. facility’s procedures may be required
before proceeding with a glucose test.
3. Contact your system administrator if
the messages continue to display after
running the required QC tests.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 11: Troubleshooting 11-9
 Symptom/Error Message Explanation How To Respond

If ketone QC is due soon, the message 1. If “Ketone QC Due in xx min.” is

“Ketone QC Due in xx min.” will display on displayed, no action is required. Ketone
the main screen. The xx is the countdown to testing can proceed.
expiry. If ketone QC is due now, the message 2. If “Ketone QC Due Now” is displayed,
“Ketone QC Due Now” will display on the then ketone QC testing per your
main screen. facility’s procedures may be required
before proceeding with a ketone test.
3. Contact your system administrator if
the messages continue to display after
running the required QC tests.

If the meter requires an upload to the data 1. Place the meter in the Abbott Docking
management system, “Upload Due Now” Station and wait for the meter to
will display on the main screen. automatically turn off with the message
“Upload Successful, Turning Off”.
2. Contact your system administrator if
the message continues to display after
docking the meter.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 11: Troubleshooting 11-10
 Symptom/Error Message Explanation How To Respond

If there is a problem with the meter’s wireless 1. Turn the meter off and then on again
module, or the meter’s self test fails, the to reestablish wireless communication.
Wireless Hardware Error icon will appear. If the problem persists contact your
Tests may still be uploaded to the data local Abbott Customer Service Office
management system via docking station or or distributor to troubleshoot the
cable (optional) when the Wireless Hardware wireless function. Wireless function
Error icon is displayed. troubleshooting is described in the
Wireless Set-Up Utility CD.

Note: Check the FreeStyle Precision Pro meter display for proper performance before every test. If at
any time the display screen becomes difficult to read, discontinue use of meter and call your local
Abbott Diabetes Care Inc. office or distributor.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 11: Troubleshooting 11-11
When a Test is Selected:

Symptom/Error Message Explanation How To Respond

The Glucose QC Interval Controls Expired Perform the remaining glucose control tests
option is set to Warn or Lockout and one or indicated in the message.
more control tests is past due.
(The menu item 2–Continue appears only
if this option is set to Warn. If the option is
set to Lockout, each control test shown on
the screen must be performed before the
patient tests start.)

The Upload Interval option is set to Warn 1. Place the meter in the docking station to
or Lockout, and the specified interval has upload the data.
been exceeded. Or,
(The menu item 2–Continue appears only Press 2 to Continue testing.
if this option is set to Warn. If the option
is set to Lockout, data must be uploaded 2. If the problem persists, contact the
before testing starts.) system administrator.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 11: Troubleshooting 11-12
 Symptom/Error Message Explanation How To Respond

The Ketone QC Interval Controls Expired Perform the remaining ketone control tests
option is set to Warn or Lockout and one or indicated in the message.
more control tests is past due.
(The menu item 2–Continue appears only
if this option is set to Warn. If the option is
set to Lockout, each control test shown on
the screen must be performed before the
patient tests start.)

The system cannot confirm the Patient ID. Press 1 to ReEnter the Patient ID.
Or,
Press 2 to Continue testing.

The scanned Patient ID is similar in format 1. Re-enter the Patient ID using the
to the test strip barcode. barcode scanner or keypad.
2. If the problem persists, contact the
system administrator.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 11: Troubleshooting 11-13
During Any Test:

Symptom/Error Message Explanation How To Respond

The barcode just scanned was not accepted. 1. Rescan the barcode or manually enter the
Possible reasons are: ID or lot number.
• The green scanner beam did not pass across 2. Notify the system administrator. The
all the bars of the code. problem may be the printing of the
• The barcode was damaged or poorly barcode or the setup.
printed.
• The barcode was not of the type specified
for this ID or lot number.

The barcode just scanned is from a foil 1. Discard the expired test strips
packet of test strips that has expired. 2. Repeat the scan with a new, unexpired
foil packet of test strips.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 11: Troubleshooting 11-14
 Symptom/Error Message Explanation How To Respond

The ID or lot number just scanned or 1. Verify and re-enter the ID or lot number
entered is too long or too short, according using the barcode scanner or keypad.
to format defined during the setup of this 2. If the problem persists, notify the system
meter. administrator.

The ID or lot number just scanned or 1. Press 1 to ReEnter the ID or lot number
entered is not on the list of acceptable IDs using the barcode scanner or keypad.
or lot numbers defined for this meter. (The Or,
menu item 2 – Continue appears only if Press 2 to Continue testing.
this option is set to Warn.) 2. If the problem persists, notify the system
administrator.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 11: Troubleshooting 11-15
 Symptom/Error Message Explanation How To Respond

The strip inserted is a Ketone strip, while Press 1 to replace with the expected test
the meter was expecting a Glucose strip. strip.
Or,
Press 2 to Exit.

This test strip is not compatible with the Repeat the scan with a FreeStyle Precision
FreeStyle Precision Pro meter. Pro compatible test strip.

The Operator ID just entered is not on the 1. Press 1 to ReEnter the ID using the
list of acceptable Operator IDs defined for barcode scanner or keypad.
this meter. Or,
(The menu item 2–Continue appears only Press 2 to Continue.
if this option is set to Warn.)
2.  If the problem persists, notify the
system administrator.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 11: Troubleshooting 11-16
 Symptom/Error Message Explanation How To Respond

The Operator ID entered is not on the list 1. Press 1 to ReEnter the Operator ID.
of acceptable Operator IDs defined for this 2.  If the problem persists, contact the
meter. system administrator for further
information on operator certification.

The Operator ID entered has expired. 1. Press 1 to ReEnter the ID using the
(The menu items 1 - ReEnter ID and barcode scanner or keypad.
2 - Continue appear only if this option is Or,
set to warn.)
Press 2 to Continue testing.
2.  If the problem persists, notify the
system administrator.

The Operator ID is due to expire. At this 1.  Press 1 to Continue with testing.

time, testing is still allowed. 2.  Contact your manager or the system
administrator for further information
about operator certification.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 11: Troubleshooting 11-17
 Symptom/Error Message Explanation How To Respond

The test result is below the measuring 1.  Repeat the test with a new test strip.
limit of the system. 2. If the result persists, follow your
facility's policy.

<20 mg/dL

The test result is above the measuring 1.  Repeat the test with a new test strip.
limit of the system. 2.  If the result persists, follow your
facility's policy.

The test strip or the test strip port is wet, 1. Remove the old test strip.
defective, contaminated, or the 2.  Press 1 to continue testing with a
wrong test strip was inserted. New Strip.
Or,
Press 2 to Exit to the Test Menu.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 11: Troubleshooting 11-18
 Symptom/Error Message Explanation How To Respond

There may be a problem with the test strip. 1.  Press 1 to repeat the test with a New
One of several 4-digit error codes may be Strip or 2 to Exit.
displayed. These codes provide Abbott
personnel additional information about the
problem. Errors include: 2. If the error occurs again, record the
4-digit error code and contact Abbott
Technical Support.
4327 - The strip was removed during Repeat the test with a new test strip.
testing.
4330 - Blood glucose may be too high to Repeat the test with a new test strip. If the
be read by the system or there may be a error occurs again, confirm the result by
problem with the test strip. performing a laboratory reference test.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 11: Troubleshooting 11-19
 Symptom/Error Message Explanation How To Respond

When a Control Test is Selected:

A control solution lot number has been Press 1 to ReEnter the lot.
entered for a different level of control test Or,
from the one that the meter expected to
run (in the usual low-to-high sequence). Press 2 to run the level of test that matches
The user may choose to enter a different lot the lot number already entered.
number (usually, for the expected level) or
to run the level of test that matches the lot
number entered.

When a Linearity Test is Selected:

A new linearity kit lot number has been Press 1 to ReEnter a different linearity kit
entered, different from the linearity panel lot number (typically, the number of the
currently stored in the meter. Only one previous kit).
panel of data is stored. The kit lot number Or,
may have been entered incorrectly, or the
user may choose to replace the earlier data. Press 2 to proceed and Replace Panel,
using the new kit lot number. The existing
linearity data will be replaced by data from
the new lot.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 11: Troubleshooting 11-20
 Symptom/Error Message Explanation How To Respond

When Data Review is Selected:

There are no stored test results for the type Press 1 to Exit and return to the Data
of data requested. Review Menu.

The meter is not able to recall a previous test Press 1 to view the Previous result.
result. This test result may not have been Or,
uploaded from the meter.
Press 2 to view the Next result.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 11: Troubleshooting 11-21
Technical Support Instructions
When you call, an Abbott representative will address the problem and/or instruct you to return the meter, test strips, control
solution and/or linearity kit. Do not return the FreeStyle Precision Pro meter or any part of the system for repair until you
receive authorisation from an Abbott representative.
To help ensure efficient resolution of the problem, complete the following steps before calling Abbott.
1. Review the troubleshooting information in this section.
2. Obtain the most recent control results and record them below.

Low Mid High

Control Solution
(If used) (If used) (If used)
Results
Expected Range
Test Strip Lot Number
Control Solution Lot Number
Date

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 11: Troubleshooting 11-22
3. Obtain the most recent linearity results and record them below.

Linearity Kit 1 2 3 4 5

Results
Expected Range
Test Strip Lot Number
Linearity Solution Lot Number
Date

4. Enter the date the problem occurred:________________________________________________________________________

5. Describe the problem and the conditions when it occurred:______________________________________________________
______________________________________________________________________________________________________
______________________________________________________________________________________________________
6. Have the FreeStyle Precision Pro meter and testing materials available when calling.

Returning a Meter
You must follow the instructions provided in the return kit when returning used meter.
Note: Do not return any used sharps in the return kit.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 11: Troubleshooting 11-23
Contacting Abbott for Service
Abbott is committed to helping you resolve any problems with the FreeStyle Precision Pro system. For technical assistance, please
contact your local office or distributor listed below.
ASIA EUROPE MIDDLE EAST
Hong Kong Ireland Saudi Arabia
美國雅培製藥有限公司 Abbott Laboratories Ireland, Ltd. Abbott Diabetes Care
香港北角電器道183號友邦廣場20樓 Abbott Diabetes Care Mediserv Co.
電話:2806-4488 Dublin, Ireland Riyadh, Saudi Arabia
1800 77 66 33 800124 1238
United Kingdom
Abbott Laboratories Ltd.
Abbott Diabetes Care
Maidenhead, Berkshire, UK
0500 467 466

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 11: Troubleshooting 11-24
12. Maintenance
Cleaning the Exterior Surface
Replacing the Strip Port Module
Replacing the Batteries
 Maintenance

The FreeStyle Precision Pro meter requires little routine maintenance. During testing, the sample remains outside the meter,
which significantly reduces the possibility of contamination. Follow your facility’s procedures for maintenance and inspection of
the system.
This chapter describes the maintenance tasks for the meter.
• Cleaning the exterior surface of the meter.
• Replacing the strip port module.
• Replacing the batteries.

Cleaning the Exterior Surface

Cleaning the exterior surface of the FreeStyle Precision Pro meter daily is recommended. Follow your facility’s policies and
procedures for infection control, which may require more frequent cleaning.
The meter should be cleaned only with a damp cloth or a sponge and a mild detergent. Acceptable cleaning solutions include
mild soap water, bleach, alcohol and ammonia based cleaners. Recommended solutions are Dispatch®, Sani-Cloth Bleach®,
Sani-Cloth® HB, Sani-Cloth® Plus, Super Sani-Cloth®, Hype-Wipe® and Virox 5®.
Cleaning solutions not listed have not been tested and may damage the meter. Contact your local Abbott Diabetes Care Inc. office
or distributor for the most up-to-date information on cleaning solutions.

IMPORTANT: Abbott Diabetes Care Inc. has not evaluated cleaning solutions for disinfection
purposes.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 12: Maintenance 12-1
Turn off the meter prior to cleaning. Wipe all surfaces until the meter is visibly clear of soil. Do not apply cleaning solution
directly to the meter. If using a pre-packaged wipe, squeeze out excess fluid prior to use. Do not immerse or autoclave the meter
or flood it with any liquid. These steps will help keep liquid from entering the meter and causing damage.

IMPORTANT: Avoid getting dust, dirt, blood, control solution, water or any other substance in the
meter’s test strip port.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 12: Maintenance 12-2
Replacing the Strip Port Module
IMPORTANT: Do NOT replace batteries and strip port module at the same time. Ensure batteries are
installed before replacing strip port module. Rechargeable batteries must be at room
temperature before they are placed in the battery compartment. The docking station
does not charge the batteries.

The strip port module is designed to minimise the potential for liquid or debris to enter the meter through the strip port. Should
blood, liquid or other contaminant enter into the strip port, the strip port module must be replaced. Make sure the area around
the strip port is completely dry prior to installing the replacement strip port module.
Removal
1. Turn the FreeStyle Precision Pro meter off by pressing the On/Off   button
on the keypad.
2. Place the meter, display screen down, on a flat surface. Place one hand on the
handle of the meter to secure it. With the other hand use a small cross head
Figure 1
(Phillips) screwdriver (not included) to remove the single screw on the back of the
strip port module. (Fig. 1)
3. Once the screw is removed, place it aside. Use your hand to carefully slide the
strip port module away from the meter. (Fig. 2)
4. Remove the strip port module entirely. Discard it and the screw in accordance
with your facility’s biohazard disposal policy. Figure 2

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 12: Maintenance 12-3
Replacement
1. Obtain a replacement strip port module.
2. Slide the replacement strip port module into position on the meter. (Fig. 3)
3. Insert strip port module firmly into place. (Fig.4)
Figure 3
4. Use a small cross head (Phillips) screwdriver to insert the new screw. This will
secure the strip port module in place. (Fig. 5)

Figure 4

Figure 5

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 12: Maintenance 12-4
Replacing the Batteries
Use the following procedure to install new batteries in the FreeStyle Precision Pro meter. The
FreeStyle Precision Pro meter requires two (2) AA alkaline, lithium or nickel cadmium (NiCad)
batteries or nickel-metal hydride (NiMH) rechargeable batteries.

1. Turn the FreeStyle Precision Pro meter off by pressing the On/Off button on the keypad.
2. Turn the meter over to remove the battery compartment cover. Figure 1
3. Press down the cover at the finger grip area firmly. Push to slide the cover off, as indicated by
the arrow. (Fig. 1)
4. When slid as far as possible, lift the cover up and away from the meter. (Fig. 2, Fig. 3)

Figure 2

Figure 3

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 12: Maintenance 12-5
5. Pull the tab to remove the batteries. (Fig. 4)
6. Discard the used batteries in compliance with your local government regulations.
7. Insert the new batteries on top of the tab, using the + and - symbols in the battery
compartment to position the new batteries with the correct polarity. (Fig. 5)
8. Align the battery compartment cover with the slots on the FreeStyle Precision Pro meter,
then slide the cover into place. (Fig. 6)
Figure 4

Note: New batteries need to be installed within 24 hours after the old batteries are
removed from the battery compartment to maintain the meter date and time.

Figure 5

The European Battery Directive requires separate collection of spent batteries, aiming
to facilitate recycling and to protect the environment. The batteries in this product
should be removed and disposed in accordance with local regulations for separate
collection of spent batteries. Contact the manufacturer for details.

Figure 6

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 12: Maintenance 12-6
13. Specifications
FreeStyle Precision Pro Meter
Symbols
Barcode Types
 Specifications

FreeStyle Precision Pro Meter

Dimension and Weight Specifications:
Length: 19.94 cm ± 2 mm (7.85 in ± .08 in) Thickness: 4.92 cm ± 2 mm (1.92 in ± .08 in)
Width: 7.45 cm ± 2 mm (2.93 in ± .08 in) Weight: 300 grams ± 15 grams (10.58 ounces ± .51 ounces)
Power Source:
Two standard alkaline, lithium or NiCad AA batteries or nickel-metal hydride (NiMH) rechargeable batteries. Battery
performance is a function of how often the meter is used and the duration time that testing is conducted. The average lithium
battery life is approximately 30 days, based on an average of 9 tests per day and meter being shut off within 2 minutes if it is
not being used (depending on barcode usage).

Memory:
Patient Test Results: 2,500
Control Test Results: 1,000
Operator IDs: 6,000
Test Strip Lots: 36 (18 Glucose, 18 Ketone)
Proficiency Test Results: 20

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 13: Specifications 13-1
Glucose Linearity Test Results: 20 Results (1 panel, 5 levels, 4 replicates per level)
Ketone Linearity Test Results: 20 Results (1 panel, 5 levels, 4 replicates per level)
Patient IDs: 6,000 patient records (name, gender, date of birth)

Environmental Specifications:
Product is intended for indoor use only.
Meter Operating Temperature: 15 °C to 40 °C ± 1°C (59 °F to 104 °F)
Meter Storage Temperature: -20 °C to 50 °C ± 1°C (-4 °F to 122 °F)
Altitude: Refer to the test strip instructions for use.
Humidity: From 10% to 90% ± 3%RH noncondensing
Rated Pollution Degree: 2

Wireless Specifications
The optional wireless function requires a WiFi enabled facility. If your agreement with Abbott Diabetes Care Inc. includes
wireless functionality on the FreeStyle Precision Pro system, your system administrator must enable both the data management
system and the individual meters for wireless functionality. Details for enabling the wireless function are described in the
Wireless Set-Up Utility CD (optional).
See the meter wireless specifications in the FreeStyle Precision Pro Wireless Setup Utility User’s Guide.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 13: Specifications 13-2
Symbols
There are special symbols that appear on the FreeStyle Precision Pro meter, test strips and docking station. Please note: Some
of the symbols listed below will not appear on your FreeStyle Precision Pro system due to differences in local regulatory
requirements.

Indicates a Glucose assay (black text on white).

Indicates a Ketone (β-hydroxybutyrate) assay (white text on purple).

Data Transfer Port.

Medical Equipment with respect to electric shock, fire and mechanical hazards only in accordance with
UL61010-1, and CAN/CSA C22.2 NO.61010-1.

This Way Up.

Temperature Limitation.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 13: Specifications 13-3
 This product must not be disposed of via municipal waste collection.
Separate collection for electrical and electronic equipment waste per Directive 2002/96/EC in the European
Union is required. The European Battery Directive requires separate collection of spent batteries, aiming
to facilitate recycling and to protect the environment. The batteries in this product should be removed
and disposed in accordance with local regulations for separate collection of spent batteries. Contact the
manufacturer for details.

Batch Code.

Use by.

Caution.

Note: Provides or refers the operator to additional or background information that may be helpful to them.

Do not reuse.

Catalogue Number.

CE Mark.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 13: Specifications 13-4
 Manufacturer.

Consult instructions for use.

Recyclable.

In vitro diagnostic medical device.

Contains FCC ID: FCC Registration.

N6C-SXSDCAG,
IC: 4908B-SXSDCAG

Biohazard

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 13: Specifications 13-5
Barcode Types
The FreeStyle Precision Pro system is compatible with both one dimensional (1D) barcodes (Codabar, Code 128, Code 39, Code
93, I 2 of 5, EAN, RSS) and two dimensional (2D) barcodes (Data Matrix, Aztec, PD-417, Micro PDF, QR Code, Maxicode,
CODABLOCK F, RSS Composite).

Note: Control characters and non-alphanumeric characters (e.g. $) are displayed as spaces in the FreeStyle
Precision Pro meter. Some barcodes may contain control characters and non-alphanumeric
characters. The Barcode Type section of the MeterCom screen allows you to set all barcode data entry
options for the Operator ID and Patient ID. The types of barcodes selected determine what codes can
be scanned into the Meter. Refer to the Meter Component Manual for detailed information.

Questions? Refer to Page 11-22 For Technical Support Instructions. Chapter 13: Specifications 13-6
This product(s) and/or its manufacture and/or use are protected by one or more of the
following patents: US5,509,410; US5,628,890; US5,727,548; US6,129,823; US6,736,957;
US6,764,581; US6,939,450; US6,377,894; US6,600,997; US6,773,671; US5,682,884;
US6,591,125; US7,058,437; US7,077,328; US7,504,019; US7,740,581; US7,896,703;
US7,896,704; US7,905,999; US7,922,883; US7,998,337; US8,118,993; US8,182,671;
US8,211,280; US8,221,612; US8,241,485; US8,241,486; USD411,989; EP1,009,850B1;
EP1,119,637B8; EP1,023,455B1; EP1135679B1; EP1457913B1; EP1801229B1;
EP1101111B1; CA2302448C; CA2337019C; CA2346415C; CA2351796C; CA2353670C;
CA2305800C. Additional patents may be issued and/or pending.
FreeStyle and related brand marks are trademarks of Abbott Diabetes Care Inc. in various
jurisdictions. Other trademarks are the property of their respective owners.
©2012 Abbott
ART25413_Rev-A 03/13

Abbott Diabetes Care Ltd.

Range Road
Witney, Oxon
OX29 0YL, UK