MediSense Precision PCx User Manual

Point-of-Care System

MediSense, Precision PCx, Precision and
QC Manager are trademarks of Abbott Laboratories.
© 2002 Abbott Laboratories.

Warning: This manual is protected by copyright law. Unauthorized reproduction or
distribution of this manual or any portion of it may result in severe civil and criminal
penalties, and will be prosecuted to the maximum extent under the law.

Healthcare Professional
Operator’s Manual
for Blood Glucose
Monitoring

Questions? Refer to Page 10-13 For Customer Care Information.

I

Introduction

1. Manual Organization................................................................... 1-1

Precision PCx Menu Tree.......................................................... 1-2

2. Overview: Understanding the Precision PCx

Point-of-Care System .................................................................. 2-1

Test Mode

3. Patient Test.................................................................................... 3-1

Operating Guidelines for all Samples....................................... 3-1

Collecting Blood Samples......................................................... 3-1

Obtaining Capillary Blood Samples ...................................... 3-1

Obtaining Venous Blood Samples.......................................... 3-2

Obtaining Arterial Blood Samples......................................... 3-2

Disposing of Waste .................................................................... 3-3

Test Procedure............................................................................ 3-3

4. Control Test .................................................................................. 4-1

Operating Guidelines for Control Solutions............................. 4-1

Test Procedure............................................................................ 4-2

Menu Mode

5. Data Review................................................................................... 5-1

Patient History ........................................................................ 5-1

Control History..................................................................... 5-15

Proficiency Data ................................................................... 5-25

Linearity Data....................................................................... 5-26

6. Proficiency Test ............................................................................. 6-1

7. Linearity Test ................................................................................ 7-1

8. Review/Change Setup................................................................... 8-1

Test Setup ................................................................................ 8-7

System Setup ........................................................................ 8-34

System Status........................................................................ 8-40

Date and Time....................................................................... 8-43

Edit Lists............................................................................... 8-46

Table of Contents

Questions? Refer to Page 10-13 For Customer Care Information.

II

9. Data Upload................................................................................... 9-1

Docking Station (optional)........................................................ 9-2

10. Troubleshooting.......................................................................... 10-1

Patient Test Results.................................................................. 10-1

Out-of-Range Control Test Results......................................... 10-2

Error Messages ........................................................................ 10-2

Contacting MediSense for Service........................................ 10-13

Returning an Instrument........................................................ 10-16

Limited Warranty................................................................... 10-16

11. Maintenance................................................................................ 11-1

Cleaning the Monitor’s Exterior Surface................................ 11-1

Replacing the Batteries ............................................................ 11-2

Six-Month Maintenance Log .................................................. 11-3

12. Specifications............................................................................... 12-1

Other Information.................................................................... 12-2

Questions? Refer to Page 10-13 For Customer Care Information.

III

Introduction

Welcome to the MediSense Precision PCx™Point-of-Care System,
the portable hospital whole blood testing system. The Precision PCx
System simplifies patient monitoring for point-of-care whole blood
glucose testing by nurses, physicians, diabetes educators, laboratory
staff and other healthcare professionals who need quick, accurate
results. The Precision PCx System includes the following:

Features and Benefits

Hand-Held Monitor The hand-held design of the monitor allows

it to be easily brought to the patient for testing.

Simplified Data Entry The monitor contains a built-in barcode scanner

which allows the operator to enter patient
identification, operator identification, test strip lot
number and other pertinent data by simply scanning
a barcode.

Easy Operation To perform a test, a test strip is inserted into the

monitor’s test strip port, and a small drop of blood
is applied to the target area on the test strip.

Rapid Test Results The monitor automatically begins testing as soon as

the sample is detected on the test strip. Results are
displayed in 20 seconds.

Easy Home Training The monitor’s design and operation are similar to

other MediSense monitors, making it easy to educate
patients on home self-testing procedures.

Infection Control The risk of contamination to operator and patient

is minimized since the blood does not enter the
monitor.

Improved Test Strip The Precision PCx System uses unique biosensor
Technology technology to obtain accurate results over a broad

range of patient hematocrit levels and sample types.
Precision PCx Test Strips and Precision PCx Plus
Test Strips with TrueMeasure

™

Technology are
approved for use with arterial, venous, capillary and
neonatal whole blood samples.

Minimal Maintenance The monitor’s exterior surface needs only to be

wiped down once a day, or as needed, and the
batteries need to be replaced or recharged when
necessary.

MediSense Precision PCx Point-of-Care System

IV

Accurate Calibration The barcode on each test strip packet label ensures

accurate calibration before each test begins.

Built-In Security Options Options in the Precision PCx Monitor enable the

requirement of Patient and Operator IDs, to include
minimum and maximum lengths. Other security
options include:

QC Interval – requires quality control tests
at regular intervals.
Operator Security – limits access to the list
of certified operators.
Strip Lot Security – test only with approved
test strip lots.
Test Security – reports control test as
Pass/Fail only. This is to prevent patient
testing from being performed while the
monitor is in control test mode.

Patient and Quality The Precision PCx Monitor can store up to 4,000
Control Data Management patient tests and 1,000 control tests. All stored data

can be automatically uploaded to the MediSense

®

QC Manager™Data Management System using the
docking station (optional) or serial cable.

Data Networking The QC Manager Data Management System provides

a simple and automated way to collect, report and
send data to the Laboratory Information System
(LIS) or Hospital Information System (HIS).

Battery Power The monitor uses 2 standard alkaline AA batteries,

or the rechargeable MediSense battery pack.

Questions? Refer to Page 10-13 For Customer Care Information.

1-1

The Precision PCx Point-of-Care System Operator's Manual provides
basic information about the Precision PCx Monitor and contains easy­to-follow, step-by-step procedures for using it.

The Precision PCx System operates using menu-driven software. The
software consists of two main menus, Test Mode and Menu Mode. Test
Mode is used to perform Patient Tests and Control Tests. Menu Mode
is used to set up the monitor's options. (See page 1-2).

The menu portion of the software is set up like a tree, with various
levels of sub-menus branching out from the main trunk. The menu
diagram on the next page, called the Precision PCx Menu Tree,
illustrates the multiple sub-menu layers. For ease of understanding in
using the monitor, this manual is organized into sections which follow
the menu.

It is recommended that the Introduction and Overview sections of
this manual be read thoroughly prior to using the monitor for testing.
These sections will acquaint users with the Precision PCx Point-of-Care
System’s features and operating controls so it can be used more
effectiv ely.

Manual Organization

1

1-2

Test Mode

Patient

Test

Control

Test

Menu Mode

1. Data Review

2. Proficiency Test

3. Linearity Test

4. Review / 5.Change
Setup

Upload

Inter

val

Operator ID Format
Patient ID Format

Comment Code
Memory Full

Results Format
Comment Code
Memory Full

QC Interval
Operator ID
Strip Lot

Glucose

Units
Sample Type
Action Range

1. Patient History
sort by:

2. Control History

3. Proficiency Data

4. Linearity Data

1. Test Setup

2. System Setup

3. System Status

4. Date and Time

All T ests
Patient ID
Operator ID
Action Range
Comment Code
Date

All T ests
Operator ID
Outside Range
Comment Code
Date

1. All Tests

2. Patient Test

3. Control Test

4. Security

5. Test Type

1. Operator List

5. Edit Lists

Add
Delete
Change

Add
Delete
Change

sort by:

2. Strip Lot
List

1.

2.

Battery Power
Temperature
Memory Gauge
Software Version

Language
Beeper On/Off
Date Format
Time Format
Password
Factory Settings

Levels

Precision PCx Menu Tree

Questions? Refer to Page 10-13 For Customer Care Information.

2-1

Understanding the Precision PCx Point-of-Care System

The Precision PCx Point-of-Care System is a portable whole blood
testing system which performs tests with quick and accurate results.
This section is intended to provide an overview of the Precision PCx
System's components and basic operations. Use product and
accessories only as directed. Failure to operate the product(s) in
accordance with the manufacturer’s documentation may impair the
product safety.

MediSense Precision PCx Point-of-Care System Components

The MediSense Precision PCx Point-of-Care System includes the
following items:

• The Precision PCx Monitor

• Precision PCx and Precision PCx Plus
Blood Glucose Test Strips

• Accessory / Carry Case (optional)

• Docking Station (optional)

The Precision PCx Monitor includes:

• Test Strip Port

• Large LCD Display

• Barcode Scanner

• Ke ypad

• Data Port

• Audible Indicator

Precision PCx Blood Glucose Test Strips

The Precision PCx and Precision PCx Plus Blood Glucose
Test Strips offer the latest advances in biosensor technology. Each test
strip is wrapped in a foil packet with a barcode label. This label holds
the calibration information about the test strip including the lot number,
the expiration date and expected control solution ranges.

Overview: 2

Precision PCx Test Strips

There are now two types of Precision PCx test strips that may be used
for testing with this system. The target area of the original Precision
PCx biosensor test strip is on the top of the strip. The target area of the
new Precision PCx Plus Test Strip with TrueMeasure™ Technology is
at the end of the strip. Only Precision PCx branded test strips should be
used for testing with this system. Note: For data management, Precision
PCx Plus Test Strips can be used only in conjunction with
QC Manager 3.0.

Inside each carton of test strips are test strip instructions for use. The
instructions contain important information about the test strip such as:
Storage and Handling, Sample Collection and Preparation, Quality
Control and Limitations of the Procedure. The section “Limitations of
the Procedure” contains the operating ranges for the system and the test
strips. Please read the instructions for use carefully.

2-2

Precision PCx
Test Strip

Lot Number

Expiration Date

Control Test Ranges

Barcode number

Barcode

Precision PCx PlusTest
Strip with T rueMeasure
Technology

T arget area:A small green and

white oval where you place a drop
of blood on top of the test strip.

T arget area:A white area where
you place a drop of blood at the
end of the strip. You can apply
blood to the edge of the strip or
on the top of the strip within this
white area.

Contact bars:At the opposite end of both test strips are three black
contact bars to be inserted into the test strip port of the monitor.

Precision PCx PlusT est Strip with
TrueMeasure T echnology
For Use with Precision PCx v2.2 Only

Precision PCx T est Strip
For Use with Precision PCx v2.0,v2.1 and v2.2

Lot Number

Barcode number

Barcode

Expiration Date

Control Test Ranges

Target Area

Contact Bars

Contact Bars

Target Area

Questions? Refer to Page 10-13 For Customer Care Information.

2-3

Accessory / Carry Case (optional)

The light yet rugged accessory/carry case holds the hand-held monitor,
test strips, glucose control solutions and other supplies in a
convenient manner.

A transparent cover allows the operator to check the supply status
without opening the case. The overall form is compact, allowing the
convenient storage of many cases in a small area.

The case holds the Precision PCx Monitor and the
following items:

• Precision PCx or Precision PCx Plus Test Strips

• Single-use Lancing Devices

• Gauze Pads

• Glucose Control Solutions

• Quick Reference Guide

Docking Station (optional)

The optional docking station will
automatically upload the data from the
monitor into a central computer via the
MediSense QC Manager Data
Management System.

To start the upload of data, simply place
the Precision PCx Monitor into the
Precision PCx Docking Station.

2-4

The monitor will automatically upload data to the MediSense QC
Manager Program. Please refer to the QC Manager Operator’s Manual
for more information.

The docking station has an additional role as a recharge station for the
MediSense rechargeable battery pack (optional). The rechargeable
battery pack must be in the monitor to take advantage of this option.

Identifying Monitor Functions

Through the monitor, the operator can view information, make
selections and enter information. The location of all the monitor
functions are shown on the following page.

Test Strip Port

After the operator scans the barcode or manually enters* information
via the monitor keypad, the operator will insert a new test strip into
the test strip port to perform a test.

Display

Here is where menu options, error codes, and test results are viewed.
Press and hold on the keypad to turn on or off the backlight for
the monitor display.

Keypad

The keypad contains the following controls:

On/Off

Press this button to turn the monitor on or off. The monitor will auto­matically turn off after 4 minutes if the monitor is left on but has not
been used.

Scan

Press the Scan button to use the laser barcode scanner. The barcode
scanner enables the operator to scan the information into the monitor
instead of manually entering the data by using the keypad. The scanner
can automatically enter the test strip information (calibration, control
range, lot number and expiration date), as well as the operator ID,
patient ID, and control lot number.

* Manual entry of strip lots with alpha-numeric barcodes is not supported.

Questions? Refer to Page 10-13 For Customer Care Information.

2-5

Numbers

The 10-digit keypad can be used to enter identification numbers
or to select an option that appears on the display.

Clear

The operator can press Clear to perform the following functions:

• To back up one space while entering numbers on the keypad.

• Clear a numerical code from the monitor after pressing Enter.

• Clear a barcode scanned by mistake.

• Return to a previous screen.

• When Clear is pressed two times, all entered numbers shown in the
display will be cleared.

Menu

When the Menu key is pressed, the following functions can be
performed:

• Return to the top of the menu.

• Switch between Test Mode and Menu Mode.

Enter

When the Enter key is pressed, it will confirm the information that was
manually entered.

Barcode Scanner

The Barcode Scanner is used to scan barcode information into the
monitor. The operator will hold the barcode scanner 3-12 inches from
the barcode to be scanned. When first using the barcode scanner, some
precautions should be taken while mastering the device.

2-6

Place the object to be scanned on a flat surface, by itself. This will
prevent other items from being accidentally scanned.

Press and hold down the Scan button to start the barcode scanner. A
visible red beam will be emitted from the monitor. Slowly move this
beam over the barcode on the item to be scanned. When the monitor
accepts the barcode, it will beep in acknowledgement. Without
releasing the Scan button, look down at the monitor. The operator
can view the data that was scanned by the monitor. Release the Scan
button to stop the scan and continue with the next step.

CAUTION: Never look into the barcode scanner beam or point it
toward anyone’s eyes. The beam could cause permanent
damage to the eye.

Class II and IIa Laser Product: Avoid Long Term Viewing of Direct
Laser Light.

Data Port

The Data Port is located at the bottom of the monitor. This port enables
the monitor to automatically transfer the data through a cable connector
to a PC, laptop, Laboratory Information System (LIS), or Hospital
Information System (HIS).

Battery Compartment

The monitor holds two AA alkaline batteries to power the monitor.
A rechargeable battery pack is also available from MediSense. The
rechargeable battery pack can recharge itself while the monitor is in the
optional docking station. To prolong the battery life of the monitor, the
monitor should be turned off when not in use. If the monitor is left on
and has not been used for 4 minutes, it will automatically shut itself off.

Questions? Refer to Page 10-13 For Customer Care Information.

2-7

Audible Indicator (not visible)

The monitor will beep to indicate one of the following:

• A successful barcode entry.

• Sample detection.

• At three seconds before the result is to appear.

• When an error occurs.

• At thirty seconds before automatic shutoff.

Data Port

This section describes the steps to be taken to test patient blood samples
using the Precision PCx Monitor.

Operating Guidelines for All Samples

Please follow the recommended guidelines so the most accurate results
will be obtained.

• Always wear gloves and follow your facility’s biohazard safety
policies and procedures when performing tests involving patient
blood samples.

• Use only control solutions approved for use on the test strip
instructions for use to verify the performance of the
Precision PCx and Precision PCx Plus Test Strips and the
Precision PCx Monitor.

• Use the test strips before their expiration date.

• Do not use test strips that are wet, bent, scratched or damaged. Use
the test strip immediately after opening its foil packet.

• Do not scan a packet’s barcode and use a test strip from another
packet. This may cause incorrect assay results to be generated.

• Cover the entire target area of the test strip with the blood sample.
The test results will not be affected if the target area has been briefly
touched with the patient’s finger, a capillary tube or pipette.

• If the test fails to start, apply a second drop of blood to the target
area within 30 seconds. If the test fails to start after the second drop
is applied, or if more than 30 seconds have passed, discard the used
test strip and repeat the test.

• After the blood is applied to the test strip and the count down begins,
do not remove or disturb the test strip.

• Use a new test strip when repeating a patient test.

• Refer to the instructions for use in the test strip box for specific
directions on storage and use of the test strips.

Questions? Refer to Page 10-13 For Customer Care Information.

3-1

Patient Test 3

3-2

Collecting Blood Samples

How to Obtain a Capillary
Blood Sample:

• Use only fresh whole
blood samples.

• Make sure no water
remains on the
puncture site.

• Collect the capillary
blood using a
lancing device and an
appropriate technique.

• Avoid squeezing the
puncture site excessively.

• Apply the drop of blood directly to the target area of the test strip,
covering the entire area.

• If necessary, the blood can be collected in a capillary tube coated
with sodium heparin,
lithium heparin, or
EDTA, and then applied
to the test strip.

How to Obtain a Venous
Blood Sample:

• Use only fresh whole
blood samples.

• Collect the venous blood
sample in a collection tube
containing sodium
heparin, lithium heparin
or EDTA ensuring that the test tube is completely filled.

• 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 syringe that contains sodium
heparin, lithium heparin or EDTA.

• 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 center
of the collection tube.

Precision PCx PlusT est Strip
with TrueMeasure T echnology
For Use with Precision PCx
v2.2 Only

Precision PCx T est Strip
For Use with Precision PCx
v2.0,v2.1 and v2.2.

Precision PCx PlusT est Strip
with TrueMeasure T echnology
For Use with Precision PCx
v2.2 Only

Precision PCx T est Strip
For Use with Precision PCx
v2.0,v2.1 and v2.2.

• Apply a drop of blood directly to the target area on the test strip,
covering the entire area.

Note: Use VENOUS MODE only for venous samples that have been
in capped tubes and have not been mixed with air. Use CAPILLARY
or ARTERIAL MODE for all other samples.

How to Obtain an Arterial
Blood Sample:

• Use only fresh whole
blood samples.

• Clear the arterial line
before drawing a blood
sample into a syringe that
contains sodium heparin,
or lithium heparin
or EDTA.

• Use the sample within
30 minutes of collection.

• Mix the syringe several
times immediately before applying the sample to the target area
on the test strip.

• Allow a drop of blood to form at the tip of the syringe.

• Cover the entire target area on the test strip with the blood sample.
The syringe can briefly touch the test strip without affecting the
test result.

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
and test strips in an approved biohazard container.

• Follow your facility’s biohazard disposal policy.

Patient Test Procedure

Use the following procedure to perform patient tests.

Note: The word “Strip” on the display always refers to the test
strip. If the monitor displays a message not indicated in these
procedures, please refer to section 10, Troubleshooting.

Questions? Refer to Page 10-13 For Customer Care Information.

3-3

Precision PCx PlusT est Strip
with TrueMeasure T echnology
For Use with Precision PCx
v2.2 Only

Precision PCx T est Strip
For Use with Precision PCx
v2.0,v2.1 and v2.2.

What You See
on the Display

What You Do Comments

3-4

3. Press Scan to scan the

Operator ID barcode,
or manually enter the
Operator ID via the
keypad, then press

Enter.

The display will prompt
for a Patient ID to be
entered, if this setting
has been enabled.

Note: If a Patient ID
prompt is not seen, skip
down to step 5.

1. Press On/Off to turn

on monitor.

The Abbott logo screen
will appear for a few
seconds followed by the
product name, software
version screen and then
the Test Mode menu.

2. Press 1 to select Patient

T est.

After the patient test is
selected, the Operator ID
screen will appear, if this
setting has been enabled.

Note: If an Operator ID
prompt is not seen, skip
down to step 4.

What You See
on the Display

What You Do Comments

Questions? Refer to Page 10-13 For Customer Support Information.

3-5

4. Press Scan to scan the

Patient ID barcode, or
manually enter the
Patient ID via the
keypad, then press
Enter.

After entering the Patient
ID, the test strip lot screen
appears next.

5. Press Scan to scan the

test strip barcode, or
manually enter* the test
strip lot number via the
keypad, then press

Enter.

After the test strip lot
number has been entered,
the Sample Type screen
will appear if this setting
has been enabled. If it
does not appear, skip
down to step 7.

6. The operator can select

one of the following:

Press 1 – Capillary or
Arterial.

Press 2 – Venous.

Note: Use VENOUS
MODE only for venous
samples that have been in
capped tubes and have not
been mixed with air. Use
CAPILLARY or
ARTERIAL MODE for
all other samples.

7. Open the foil test strip

packet at the notch and
tear up or down to
remove the test strip.

* Manual entry of strip lots with alpha-numeric barcodes is not supported.

What You See
on the Display

What You Do Comments

3-6

8. With the contact bars

facing up, insert the
test strip into the test
strip port until it stops.

The Apply Sample screen
will appear.

9. Apply a drop of blood

directly from the
patient’s finger or from
a syringe to the target
area on the test strip.

The monitor beeps when
the sample is accepted.
The Sample Accepted
screen will appear. For
detailed description of the
test strip target area, refer
to page 2-2.

The test starts
automatically, as the
sample is accepted.

10. Wait for the monitor

to analyze the sample
and display the test
result.

The monitor counts down
20 seconds, then displays
the test result.

11. Note the test result

and whether it falls
outside the action
range.

If the test result is above
or below the action range,
an up or down triangle
appears in front of the test
result.

(5.8 mmol/L)

What You See
on the Display

What You Do Comments

Questions? Refer to Page 10-13 For Customer Support Information.

3-7

For Out-of-Range results,
refer to your institution’s
protocol.

NOTE: The Outside
Action Range screen will
appear if the Patient Test
Out-of-Range Comment
Code is enabled and the
following two conditions
are met:

A. The Action Range is

set up.

B. The test result is out of

the Action Range.

The monitor may be
enabled to scan or enter a
1- to 2-digit comment
code. If there is no
prompt to enter a
comment code, skip
down to step 12.

NOTE: The In-Range
Action Range screen will
appear if the Patient Test
In-Range Comment Code
is enabled and the
following conditions are
met:

A. The action range

is defined.

B. The test result is within

the Action Range.

12. Remove the test strip

from the monitor when
finished testing.

(▲21.9 mmol/L)

(5.8 mmol/L)

What You See
on the Display

What You Do Comments

3-8

13. The operator can

select one of the
following options:

Press 1 – Next Patient.
Press 2 – Repeat Test.
Press 3 – Patient History.

If 1 is selected, the Scan
Patient ID screen will
appear. Return to step 4
to continue with testing
on the next patient.

If 2 is selected, the Scan
or Enter Strip Lot screen
will appear. Return to step
5 to repeat the test.

If 3 is selected, the
monitor will display the
last test result for this
patient as well as allow
the operator to view
previous results.

Refer to the section
entitled Data Review for
Patient History for further
information.

(5.8 mmol/L)

Important: If the blood glucose result appears to be inconsistent (lower or
higher than expected), 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 your healthcare professional before making any
changes to diabetes medication plans if:

• The blood glucose results are not consistent with the physical symptoms
AND you have ruled out common errors in technique.

• The blood glucose result is less than 50 mg/dL (2.8 mmol/L) or greater
than 300 mg/dL (16.7 mmol/L).

Questions? Refer to Page 10-13 For Customer Care Information.

4-1

This section describes the steps to be taken to test Control Solutions in
order to verify the performance of the Precision PCx Monitor and
Precision PCx and Precision PCx Plus Test Strips.
The quality control features of the monitor can be customized to fit the
requirements of each facility. The monitor can be set to require:

• Tests of Low, Normal, and High Control Solutions or any variation of
this depending on the facility’s policy

• Tests of Control Solutions at regular times or time intervals, or by
number of patient tests

• Control test results will appear as Numeric or Pass/Fail.

These quality control features can be set through the Menu Mode menu
(Change Setup/Test Setup Menu).

Operating Guidelines for Control Solution Testing

Observe the following guidelines to obtain optimal quality control results
using the Precision PCx System:

• Use only control solutions approved for use on the test strip instructions
for use to verify the performance of the Precision PCx and Precision
PCx Plus Test Strips and the Precision PCx Monitor.

• When opening a new bottle, write the current date on the bottle label.
Each bottle of control solution is stable for 90 days after opening
(replace cap tightly after each use). Discard all unused solutions 90 days
after opening.

• 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 nozzle of the bottle.

• Do not scan one test strip packet’s barcode and use a test strip from
another packet. This may cause incorrect assay results to be generated.

• Replace the correct cap on the bottle and tighten the cap immediately
after each use.

• Store the control solutions at temperatures between 39º and 86ºF
(4º and 30ºC).

• Do not use control solutions after the expiration date printed on the
bottles and the box. The Precision PCx Monitor does not accept control
solutions that have passed their expiration date.

When To Test Control Solutions

• As required by your facility’s quality policy or local regulatory
requirements.

• When you question blood glucose results

• When you open a new lot of test strips

Control Test 4

4-2

What You See
on the Display

What You Do Comments

Control Test Procedure

Use the following procedure to perform control tests.

Note: The word “Strip” on the display always refers to the test
strip. If the monitor displays a message not indicated in these
procedures, please refer to section 10, Troubleshooting.

1. Press On/Off to turn on

the monitor.

The Abbott logo screen
will appear for a few
seconds followed by the
product name, software
version and then the Test
Mode menu.

2. Press 2 – Control Test. After the control test is

selected, the Operator ID
screen may appear, if the
setting has been enabled.

3. Press Scan to scan the

Operator ID barcode, or
manually enter the
Operator ID via the
keypad, then press

Enter.

If the Operator ID is not
required, just press enter.

After the Operator ID is
entered, the Low Level
Solution Lot screen will
appear.

4. Scan or manually enter

the low control solution
lot number via the
keypad, then press

Enter.

The Strip Lot screen will
appear next.

If the Unexpected Level
screen appears, the
operator may either:

1. Enter 1 to ReEnter the
expected level.

2. Enter 2 to continue to
test the unexpected
level.

Questions? Refer to Page 10-13 For Customer Care Information.

4-3

7. With the contact bars

facing up, insert the test
strip into the test strip
port until it stops.

The monitor will prompt
the operator to apply the
desired control solution
to the test strip.

What You See
on the Display

What You Do Comments

5. Scan or manually

enter* the test strip lot
number via the keypad,
then press Enter.

After the test strip lot
number is entered, the
monitor will prompt for
a test strip to be inserted
into the test strip port.

6. Open the foil test strip

packet at the notch and
tear up or down to
remove the test strip.

* Manual entry of strip lots with alpha-numeric barcodes is not supported.

Precision PCx PlusT est Strip
with TrueMeasure T echnology
For Use with Precision PCx
v2.2 Only

Precision PCx T est Strip
For Use with Precision PCx
v2.0,v2.1 and v2.2.

4-4

What You See
on the Display

What You Do Comments

9. Wait for the monitor to

analyze the control
solution and display the
test result.

The monitor counts down
20 seconds then displays
the test result.

The test starts
automatically as the
sample is accepted.

(2.7 mmol/L)

10. Note the test result

and whether it falls
within the acceptable
range.

Control test results can
appear as numeric or
PASS/FAIL, depending on
how the test is setup.

The display also shows
the control level, the
control range, date
and time.

8. Gently invert the

required control
solution bottle 3-4
times then apply a drop
to the target area on the
test strip.

The monitor beeps when
the sample is accepted.
The Sample Accepted
screen will be displayed.
Recap the control solution
bottle tightly.
For a detailed description
of the test strip target
area, refer to page 2-2.

Questions? Refer to Page 10-13 For Customer Care Information.

4-5

14. The operator may

select one of the
following:

Press 1 – Next Level.
Press 2 – Repeat Test
Press Menu to return to

the Menu Mode menu.
Press On/Off to turn off

the monitor.

If 1 is selected, the next
level test will appear. The
operator may perform the
next level control test by
returning to Step 4.

If 2 is selected, the Scan
or Enter Strip Lot screen
will appear.

Return to step 5 to repeat
the test.

What You See
on the Display

What You Do Comments

13. Remove the test strip

from the monitor
when finished testing.

(2.7 mmol/L)

11. Note the test result

and whether it falls
within the acceptable
range.

The display shows the
control level, PASS/FAIL,
date and time.

12. If required, scan or

manually enter the
comment code, and
press Enter .

The monitor may be
enabled to scan or
enter a 1- to 2-digit
comment code. If
there is no prompt to
enter a comment code,
skip down to step 13.

An “X” will appear in
front of a test result that is
Out-of-Range.

(x3.7 mmol/L)

Patient History

The Precision PCx Monitor stores up to 4,000 patient tests that can be
retrieved by the following categories:

All Tests: This option displays all patient test results, starting with

the most recent test results (reverse chronological order).

Patient ID: This will display the test results for a particular patient,

starting with the most recent test.

Operator ID: This will show test results performed by a particular

operator, starting with the most recent test.

Action Range: This will display the test results that fall outside of

the action range.

Comment Code: This shows the test results for all tests tagged with

a specific comment code.

Date: This will display all the test results for a specific date, starting

with the most recent test done on that date.

5-1

Questions? Refer to Page 10-13 For Customer Care Information.

Data Review 5

5-2

What You See
on the Display

What You Do Comments

Data Review:

Follow these steps to access the Data Review menu:
If the monitor displays a message not indicated in these procedures,
please refer to section 10, Troubleshooting.

1. Press the On/Off

button to turn the
monitor on.

The Abbott logo screen
will appear for a few
seconds, followed by the
product name, software
version and then the Test
Mode menu.

2. Press the Menu button. The Menu Mode screen

will appear next.

3. Press 1 – Data Review. The Data Review menu

appears.

At this point, Patient
History, Control History,
Proficiency Data as well
as Linearity Data can be
viewed.

Questions? Refer to Page 10-13 For Customer Care Information.

5-3

Data Review for Patient History by All Tests:

Please refer to page 5-2 of the Data Review section for the step-by-step
instructions to access the Data Review menu.

Note: If no information is stored for the desired category that was
selected, the following message will be displayed on the monitor:
“No Stored Tests”.

Note: If no tests match the criteria specified, this message will be
displayed on the monitor: “No Tests Match Request”. If the
monitor displays a message not indicated in these procedures,
please refer to section 10, Troubleshooting.

What You See
on the Display

What You Do Comments

1. Press 1 – Patient

History.

The Patient History menu
now appears.

2. Press 1 – All Tests. The monitor shows the

most recent patient test
result.

5-4

3. The operator can select

one of the following
options:

Press 1 – Previous, view
the previous test result.

Press 2 – Next, view the
next test result.

The number that appears
to the right of 1-Previous
and 2-Next on the monitor
indicates the number of
tests available for review.

The display also shows:
p: Patient ID
o: Operator ID
12 : Comment Code
ven: Venous Sample

4. When finished

reviewing the data, the
operator can:

Press Clear to return to
the Patient History menu.

Press Menu to return to
the Menu Mode menu.

Press On/Off to turn off
the monitor.

What You See
on the Display

What You Do Comments

(5.8 mmol/L)

(▲21.9 mmol/L)

Questions? Refer to Page 10-13 For Customer Care Information.

5-5

What You See
on the Display

What You Do Comments

Data Review for Patient History by Patient ID:

Please refer to page 5-2 of the Data Review section for the step-by-step
instructions to access the Data Review menu.

Note: If no information is stored for the desired category that was
selected, the following message will be displayed on the monitor:
“No Stored Tests”.

Note: If no tests match the criteria specified, this message will be
displayed on the monitor: “No Tests Match Request”.

If the monitor displays a message not indicated in these procedures,
please refer to section 10, Troubleshooting.

1. Press 1 – Patient

History.

The Patient History menu
now appears.

2. Press 2 – Patient ID. The monitor will prompt

for the Patient ID to be
scanned or entered.

3. Scan or manually enter

the Patient ID via the
keypad, then press

Enter.

5-6

What You See
on the Display

What You Do Comments

5. When finished

reviewing the data, the
operator can:

Press Clear to return to
the Patient ID screen.

Press Menu to return to
the Menu Mode menu.

Press On/Off to turn off
the monitor.

4. The operator can select

one of the following
options:

Press 1 – Previous, view
the previous test result.

Press 2 – Next, view the
next test result.

The number that appears
to the right of 1-Previous
and 2-Next on the monitor
indicates the number of
tests available for review.

The display also shows:
p: Patient ID
o: Operator ID
12 : Comment Code
ven: Venous Sample

(5.8 mmol/L)

Questions? Refer to Page 10-13 For Customer Care Information.

5-7

What You See
on the Display

What You Do Comments

Data Review for Patient History by Operator ID:

Please refer to page 5-2 of the Data Review section for the step-by-step
instructions to access the Data Review menu.

Note: If no information is stored for the desired category that was
selected, the following message will be displayed on the monitor:
“No Stored Tests”.

Note: If no tests match the criteria specified, this message will be
displayed on the monitor: “No Tests Match Request”.

If the monitor displays a message not indicated in these procedures,
please refer to section 10, Troubleshooting.

1. Press 1 – Patient

History.

The Patient History menu
now appears.

2. Press 3 – Operator ID. The monitor will prompt

for the Operator ID to be
scanned or entered.

3. Scan or manually enter

the Operator ID via the
keypad, then press

Enter.

The monitor shows the
result of the operator's
most recent patient test
result.

5-8

What You See
on the Display

What You Do Comments

4. The operator can select

one of the following
options:

Press 1 – Previous, view
the previous test result.

Press 2 – Next, view the
next test result.

The number that appears
to the right of 1-Previous
and 2-Next on the monitor
indicates the number of
tests available for review.

The display also shows:
p: Patient ID
o: Operator ID
12 : Comment Code
ven: Venous Sample

5. When finished

reviewing the data,
the operator can:

Press Clear to return to
the Operator ID screen.

Press Menu to return to
the Menu Mode menu.

Press On/Off to turn off
the monitor.

(5.8 mmol/L)

Questions? Refer to Page 10-13 For Customer Care Information.

5-9

What You See
on the Display

What You Do Comments

Data Review by Patient History for Action Range:

Please refer to page 5-2 of the Data Review section for the step-by-step
instructions to access the Data Review menu.

Note: If no information is stored for the desired category that was
selected, the following message will be displayed on the monitor:
“No Stored Tests”.

Note: If no tests match the criteria specified, this message will be
displayed on the monitor: “No Tests Match Request”.

If the monitor displays a message not indicated in these procedures,
please refer to section 10, Troubleshooting.

1. Press 1 – Patient

History.

The Patient History menu
now appears.

2. Press 4 – Action Range. The monitor displays the

most recent test result that
is outside the action
range.

5-10

What You See
on the Display

What You Do Comments

3. The operator can select

one of the following
options:

Press 1 – Previous, view
the previous test result.

Press 2 – Next, view the
next test result.

The number that appears
to the right of 1-Previous
and 2-Next on the monitor
indicates the number of
tests available for review.

The display also shows:
p: Patient ID
o: Operator ID
12 : Comment Code
ven: Venous Sample

Indicates above
action range

Indicates below action
range

4. When finished

reviewing the data,
the operator can:

Press Clear to return to
the Patient History menu.

Press Menu to return to
the Menu Mode menu.

Press On/Off to turn off
the monitor.

(▲ 20.1 mmol/L)

Questions? Refer to Page 10-13 For Customer Care Information.

5-11

What You See
on the Display

What You Do Comments

Data Review for Patient History by Comment Code:

Please refer to page 5-2 of the Data Review section for the step-by-step
instructions to access the Data Review menu.

Note: If no information is stored for the desired category that was
selected, the following message will be displayed on the monitor:
“No Stored Tests”.

Note: If no tests match the criteria specified, this message will be
displayed on the monitor: “No Tests Match Request”.

If the monitor displays a message not indicated in these procedures,
please refer to the section 10, Troubleshooting.

1. Press 1 – Patient

History.

The Patient History menu
now appears.

2. Press 5 – Comment

Code.

The monitor will prompt
for the comment code to
be scanned or entered.

3. Scan or manually enter

the desired comment
code via the keypad,
then press Enter.

The monitor will show the
most recent test result for
the selected comment
code.

5-12

What You See
on the Display

What You Do Comments

4. The operator can select

one of the following
options:

Press 1 – Previous, view
the previous test result.

Press 2 – Next, view the
next test result.

The number that appears
to the right of 1-Previous
and 2-Next on the monitor
indicates the number of
tests available for review.
The display also shows:

p: Patient ID
o: Operator ID
12 : Comment Code
ven: Venous Sample

5. When finished

reviewing the data,
the operator can:

Press Clear to return
to the Comment Code
screen.

Press Menu to return to
the Menu Mode menu.

Press On/Off to turn off
the monitor.

(5.8 mmol/L)

Questions? Refer to Page 10-13 For Customer Care Information.

5-13

What You See
on the Display

What You Do Comments

Data Review for Patient History by Selected Date:

Please refer to page 5-2 of the Data Review section for the step-by-step
instructions to access the Data Review menu.

Note: If no information is stored for the desired category that was
selected, the following message will be displayed on the monitor:
“No Stored Tests”.

Note: If no tests match the criteria specified, this message will be
displayed on the monitor: “No Tests Match Request”.

If the monitor displays a message not indicated in these procedures,
please refer to the section 10, Troubleshooting.

1. Press 1 – Patient

History.

The Patient History menu
now appears.

2. Press 6 – Date. The monitor will now

prompt for the desired
date to be entered.

3. Enter the desired date

for review then press

Enter.

The operator will enter in
the date using two digits
for month/day/year.
For example, June 8, 2001
becomes 06/08/01.

5-14

What You See
on the Display

What You Do Comments

4. The operator can select

one of the following
options:

Press 1 – Previous, view
the previous test result.

Press 2 – Next, view the
next test result.

The number that appears
to the right of 1-Previous
and 2-Next on the monitor
indicates the number of
tests available for review.

The monitor also shows:
p: Patient ID
o: Operator ID
12 : Comment Code
ven: Venous Sample

5. When finished

reviewing the data,
the operator can:

Press Clear to return to
the Enter Date screen.

Press Menu to return to
the Menu Mode menu.

Press On/Off to turn off
the monitor.

(5.8 mmol/L)

Control History

The Precision PCx monitor can store up to 1,000 control tests that can
be retrieved by the following categories:

All Tests: This shows all control test results in memory starting with

the most recent test result in memory (reverse chronological order).

Operator ID: This shows the control test results that were performed

by a particular operator, starting with the most recent test.

Outside Range: This shows all the control test results that fell

outside of the acceptable ranges.

Comment Code: This shows all the control test results by comment

code.

Date: This shows the control test results performed on a specific

date, starting with the most recent test of the day.

Data Review for Control History for All Tests:

Please refer to page 5-2 of the Data Review section for the step-by-step
instructions to access the Data Review menu.

Note: If no information is stored for the desired category that was
selected, the following message will be displayed on the monitor:
“No Stored Tests”.

Note: If no tests match the criteria specified, this message will be
displayed on the monitor: “No Tests Match Request”.

If the monitor displays a message not indicated in these procedures,
please refer to section 10, Troubleshooting.

Questions? Refer to Page 10-13 For Customer Care Information.

5-15

What You See
on the Display

What You Do Comments

1. Press 2 – Control

History.

The Control History menu
now appears.

2. Press 1 – All Tests. The monitor shows the

result of the most recent
control test.

5-16

What You See
on the Display

What You Do Comments

3. The operator can select

one of the following
options:

Press 1 – Previous, view
the previous test result.

Press 2 – Next, view the
next test result.

The number that appears
to the right of 1-Previous
and 2-Next on the monitor
indicates the number of
tests available for review.

The display also shows
the acceptable range for
this test and:

o: Operator ID
0 : Comment Code

4. When finished

reviewing the data,
the operator can:

Press Clear to return to
the Control History menu.

Press Menu to return to
the Menu Mode menu.

Press On/Off to turn off
the monitor.

(2.3 mmol/L)

Data Review for Control History by Operator ID:

Please refer to page 5-2 of the Data Review section for the step-by-step
instructions to access the Data Review menu.

Note: If no tests are stored for the desired category that was
selected, the following message will be displayed on the monitor:
“No Stored Tests”.

Note: If no tests match the criteria specified, this message will be
displayed on the monitor: “No Tests Match Request”.

If the monitor displays a message not indicated in these procedures,
please refer to section 10, Troubleshooting.

Questions? Refer to Page 10-13 For Customer Care Information.

5-17

What You See
on the Display

What You Do Comments

1. Press 2 – Control

History.

The Control Test History
menu now appears.

2. Press 2 – Operator ID. The monitor will prompt

for the Operator ID to be
scanned or entered.

3. Scan or manually enter

the Operator ID via the
keypad, then press

Enter.

The monitor will display
the Operator's most recent
control test result.

5-18

What You See
on the Display

What You Do Comments

4. The operator can select

one of the following
options:

Press 1 – Previous, view
the previous test result.

Press 2 – Next, view the
next test result.

The number that appears
to the right of 1-Previous
and 2-Next on the monitor
indicates the number of
tests available for review.

The display also shows
the acceptable range for
this test and:

o: Operator ID
0 : Comment Code

5. When finished

reviewing the data,
the operator can:

Press Clear to return to
the Operator ID screen.

Press Menu to return to
the Menu Mode menu.

Press On/Off to turn off
the monitor.

(2.3 mmol/L)

Questions? Refer to Page 10-13 For Customer Care Information.

5-19

Data Review for Control History by Outside Range Results:

Please refer to page 5-2 of the Data Review section for the step-by-step
instructions to access the Data Review menu.

Note: If no tests are stored for the desired category that was
selected, the following message will be displayed on the monitor:
“No Stored Tests”.

Note: If no tests match the criteria specified, this message will be
displayed on the monitor: “No Tests Match Request”.

If the monitor displays a message not indicated in these procedures,
please refer to section 10, Troubleshooting.

What You See
on the Display

What You Do Comments

1. Press 2 – Control

History.

The Control Test History
menu now appears.

2. Press 3 – Outside

Range.

The monitor shows the
most recent control test
result that is outside the
acceptable range.

5-20

What You See
on the Display

What You Do Comments

4. When finished

reviewing the data,
the operator can:

Press Clear to return to
the Control History menu.

Press Menu to return to
the Menu Mode menu.

Press On/Off to turn off
the monitor.

3. The operator can select

one of the following
options:

Press 1 – Previous, view
the previous test result.

Press 2 – Next, view the
next test result.

The number that appears
to the right of 1-Previous
and 2-Next on the monitor
indicates the number of
tests available for review.

The display also shows
the acceptable range for
this test as well as:

o: Operator ID
2 : Comment Code
X: Outside Range

(X3.5 mmol/L)

Questions? Refer to Page 10-13 For Customer Care Information.

5-21

Data Review for Control History by Comment Code:

Please refer to page 5-2 of the Data Review section for the step-by-step
instructions to access the Data Review menu.

Note: If no tests are stored for the desired category that was
selected, the following message will be displayed on the monitor:
“No Stored Tests.”

Note: If no tests match the criteria specified, this message will be
displayed on the monitor: “No Tests Match Request”.

If the monitor displays a message not indicated in these procedures,
please refer to section 10, Troubleshooting.

What You See
on the Display

What You Do Comments

1. Press 2 – Control

History.

The Control Test History
menu now appears.

2. Press 4 – Comment

Code.

The monitor will prompt
for the comment code to
be scanned or entered.

3. Scan or manually enter

the comment code via
the keypad, then press

Enter.

The monitor will display
the result of the most
recent control test for the
specified comment code.

5-22

What You See
on the Display

What You Do Comments

4. The operator can select

one of the following
options:

Press 1 – Previous, view
the previous test result.

Press 2 – Next, view the
next test result.

The number that appears
to the right of 1-Previous
and 2-Next on the monitor
indicates the number of
tests available for review.

The display also shows
the acceptable range for
this test and:

o : Operator ID
2 : Comment Code
X: Outside Range

5. When finished

reviewing the data,
the operator can:

Press Clear to return
to the Comment Code
screen.

Press Menu to return to
the Menu Mode menu.

Press On/Off to turn off
the monitor.

(X3.5 mmol/L)

Questions? Refer to Page 10-13 For Customer Care Information.

5-23

Data Review for Control History for Selected Date:

Please refer to page 5-2 of the Data Review section for the step-by-step
instructions to access the Data Review menu.

Note: If no tests are stored for the desired category that was
selected, the following message will be displayed on the monitor:
“No Stored Tests”.

Note: If no tests match the criteria specified, this message will be
displayed on the monitor: “No Tests Match Request”.

If the monitor displays a message not indicated in these procedures,
please refer to section 10, Troubleshooting.

What You See
on the Display

What You Do Comments

1. Press 2 – Control

History.

The Control Test History
menu now appears.

2. Press 5 – Date. The monitor will prompt

for a specified date to be
entered.

3. Enter a date then press
Enter.

The monitor will display
the most recent control
test result for the specified
date.

5-24

What You See
on the Display

What You Do Comments

4. The operator can select

one of the following
options:

Press 1 – Previous, view
the previous test result.

Press 2 – Next, view the
next test result.

The number that appears
to the right of 1-Previous
and 2-Next on the monitor
indicates the number of
tests available for review.

The display also shows
the acceptable range for
this test and:

o : Operator ID
0 : Comment Code

5. When finished

reviewing the data,
the operator can:

Press Clear to return to
the Enter Date screen.

Press Menu to return to
the Menu Mode menu.

Press On/Off to turn off
the monitor.

(2.3 mmol/L)

Questions? Refer to Page 10-13 For Customer Care Information.

5-25

What You See
on the Display

What You Do Comments

Data Review for Proficiency Data

The monitor stores the last 60 proficiency test results.
Please refer to the beginning of the Data Review for the step-by-step

instructions to access the Data Review menu.

Note: If no tests are stored for the desired category that was
selected, the following message will be displayed on the monitor:
“No Stored Tests”.

If the monitor displays a message not indicated in these procedures,
please refer to section 10, Troubleshooting.

1. Press 3 – Proficiency

Data.

The monitor now shows
the most recent
proficiency test result.

2. The operator can select

one of the following
options:

Press 1 – Previous, view
the previous test result.

Press 2 – Next, view the
next test result.

3. When finished

reviewing the data,
the operator can:

Press Clear to return to
the Data Review screen.

Press Menu to return to
the Menu Mode menu.

Press On/Off to turn off
the monitor.

The number that appears
to the right of 1-Previous
and 2-Next on the monitor
indicates the number of
tests available for review.

The display shows the
following:

s : Sample Type or ID
o : Operator ID
0 : Comment Code

(2.5 mmol/L)

5-26

What You See
on the Display

What You Do Comments

Data Review for Linearity Data

The monitor stores the last linearity panel that includes a maximum
of 4 replicates for 5 levels (20 tests).*

Please refer to the beginning of the Data Review section for the step­by-step instructions to access the Data Review menu.

Note: If no tests are stored for the desired category that was
selected, the following message will be displayed on the monitor:
“No Stored Tests”.

If the monitor displays a message not indicated in these procedures,
please refer to section 10, Troubleshooting.

1. Press 4 – Linearity

Data.

The monitor now shows the
most recent Linearity Test.

At the top of the display
the test level is indicated.
The Level indicates Level
1-5 while Test indicates
1-4 replicates at that level.

2. The operator can select

one of the following
options:

Press 1 – Previous, view
the previous test result.

Press 2 – Next, view the
next test result.

3. When finished

reviewing the data,
the operator can:

Press Clear to return to
the Data Review screen.

Press Menu to return to
the Menu Mode menu.

Press On/Off to turn off
the monitor.

The number that appears
to the right of 1-Previous
and 2-Next on the monitor
indicates the number of
tests available for review.

The display also shows
the following:

o: Operator ID

(15.3 mmol/L)

*It is outside the intended use of the PCx/QCM system to perform a test in linearity mode on a PCx

instrument and change the test result record to a patient result in QCM Data Management System.
Linearity test results outside the test strip assay range should only be used to set linearity
performance on the PCx instrument. The performance of the test strips has not been verified outside
the assay range listed on the test strip instructions for use.

The Proficiency Test menu enables the operator to perform unknown
sample test challenges if required by facility policy.

Use the following procedures to perform a proficiency test.
If the monitor displays a message not indicated in these procedures,

please refer to section 10, T roubleshooting.

6-1

Questions? Refer to Page 10-13 For Customer Care Information.

Proficiency Test 6

What You See
on the Display

What You Do Comments

1. Press the On/Off

button to turn on
the monitor.

The Abbott logo screen
appears for a few seconds,
followed by the product
name, the software
version screen, then the
Test Mode menu.

2. Press Menu. The Menu Mode screen

now appears.

3. Press 2 – Proficiency

T est.

The monitor will prompt
for the Operator ID to be
scanned or entered.

4. Scan or manually enter

the Operator ID via the
keypad, then press

Enter.

The monitor will prompt
for the Sample ID to be
scanned or entered.

5. Scan or manually enter

the Sample ID via the
keypad, then press

Enter.

The monitor will prompt
for the Strip Lot number
to be scanned or entered.

What You See
on the Display

What You Do Comments

6-2

6. Scan or manually

enter* the test strip lot
number via the keypad,
then press Enter.

The monitor will prompt
the operator to insert the
test strip.

7. Open the foil test strip

packet at the notch and
tear up or down to
remove the test strip.

8. With the contact bars

facing up, insert the test
strip into the test strip
port until it stops.

The monitor will prompt
the operator to apply the
sample to the test strip.

* Manual entry of strip lots with alpha-numeric barcodes is not supported.

Precision PCx PlusT est Strip
with TrueMeasure T echnology
For Use with Precision PCx
v2.2 Only

Precision PCx T est Strip
For Use with Precision PCx
v2.0,v2.1 and v2.2.

Questions? Refer to Page 10-13 For Customer Care Information.

What You See
on the Display

What You Do Comments

The test starts
automatically, as the
sample is accepted.

10. Wait for the monitor

to analyze the sample
and display the test
result.

The monitor counts down
20 seconds then displays
the test result.

11. If the operator is

prompted to enter a
comment code,
continue to step 12;
otherwise skip
forward to step 13.

12. Scan or manually

enter the comment
code via the keypad,
then press Enter.

The monitor returns to the
Results menu. The
comment code number
that was entered will
appear in a box to the left
of the test result.

13. The operator will

select one of the
following options:

Press 1 – Next Test.
Press Menu to return to

the Menu Mode.
Press On/Off to turn off

the monitor.

The operator can refer
back to step 5 for the
steps to perform any
additional proficiency
testing at this time.

(14.6 mmol/L)

(14.6 mmol/L)

(14.6 mmol/L)

9. Gently invert the

sample bottle 3-4 times
then apply a drop of the
sample to the target
area on the test strip.

The monitor beeps when
the sample is accepted.
The Sample Accepted
Screen will be displayed.

6-3

The Linearity Test menu enables the operator to verify method linearity
using a Linearity Assessment Kit.*

Please use the following procedures to perform a Linearity Test.
If the monitor displays a message not indicated in these procedures,

please refer to section 10, Troubleshooting.

Questions? Refer to Page 10-13 For Customer Care Information.

1. Press On/Off to turn
on monitor.

The Abbott logo screen
will appear for a few
seconds, followed by the
product name, the
software version, then the
Test Mode menu.

2. Press Menu. The Menu Mode menu

will appear.

3. Press 3 – Linearity
T est.

The monitor will prompt
for the Operator ID to be
scanned or entered.

4. Press Scan or manually
enter the Operator ID
via the keypad, then
press Enter .

The monitor will next
prompt for the Linearity
Kit lot number to be
scanned or entered.

What You See
on the Display

What You Do Comments

*It is outside the intended use of the PCx/QCM system to perform a test in linearity mode on a PCx

instrument and change the test result record to a patient result in QCM Data Management System.
Linearity test results outside the test strip assay range should only be used to set linearity
performance on the PCx instrument. The performance of the test strips has not been verified outside
the assay range listed on the test strip instructions for use.

7-1

Linearity Test 7

What You See
on the Display

What You Do Comments

7-2

5. Scan or manually enter

the linearity kit lot
number via the keypad,
then press Enter. If the
monitor prompts for a
level to be entered, skip
to step 7.

If the linearity kit lot
number that was entered
is different from the
previous one, the monitor
will prompt the operator
to do one of two actions:
either re-enter the existing
linearity kit lot number or
replace the existing
linearity kit lot number
with the new linearity kit
lot number.

6. The operator can

perform one of the
following actions:

Press 1 – ReEnter
Kit Lot.

Press 2 – Replace Panel.

If 1 is pressed, the
monitor will return to the
previous screen so the
operator can scan or enter
the linearity kit lot
number.

The monitor will prompt
the operator to select a
level.

7. Enter the number of

the level of the next test
to be run.

There can be up to 4
replicates per level. The
number in the parenthesis
indicates the number of
replicates already run for
that level. When a level is
full, the menu item (1­Level 1) will no longer
appear.

8. If the operator presses

6 for a new panel, the
monitor will again
prompt the operator to
select a level.

The monitor will
prompt the operator to
scan or manually enter
the test strip lot number.

Questions? Refer to Page 10-13 For Customer Care Information.

What You See
on the Display

What You Do Comments

9. Scan or manually
enter* the test strip lot
number via the keypad,
then press Enter.

The monitor will prompt
for a new test strip to be
inserted into the test strip
port.

10. Open the foil test strip

packet at the notch
and tear up or down to
open the packet, then
remove the test strip.

11. With the contact bars

facing up, insert the
test strip into the test
strip port until it stops.

The monitor will prompt
the operator to apply the
sample to the test strip.

* Manual entry of strip lots with alpha-numeric barcodes is not supported.

Precision PCx PlusT est Strip
with TrueMeasure T echnology
For Use with Precision PCx
v2.2 Only

Precision PCx T est Strip
For Use with Precision PCx
v2.0,v2.1 and v2.2.

7-3

What You See
on the Display

What You Do Comments

7-4

15. Press Scan or

manually enter the
comment code via
the keypad then
press Enter .

The monitor will return
to the results screen. The
comment code number
that was entered will
appear in a box to the
left of where the result
is displayed.

16. The operator can do

one of the following
options:

Press 1 – Next Level.
Press 2 – Same Level.
Press the Menu button to

return to the Menu Mode.
Press On/Off to turn off

monitor.

The operator can press 2
to perform more tests for
the same level (return to
step 9) or press 1 to
perform tests for another
level (return to step 8).

14. Note the result. If the

operator is prompted
to enter a comment
code, continue to step
15, otherwise skip to
step 16.

The display includes the
level and test numbers,
date and time. Level
indicates Level 1-5.
Test indicates replicates
1-4 for that level.

The test starts
automatically, as the
sample is accepted.

(14.6 mmol/L)

(14.6 mmol/L)

(14.6 mmol/L)

13. Wait for the monitor

to analyze the sample
and display the test
result.

The monitor counts down
20 seconds then displays
the test result.

12. Gently invert the

sample 3-4 times then
apply a drop of the
sample to the target
area on the test strip.

The monitor beeps when
the sample is accepted.
The Sample Accepted
Screen will appear.

The Precision PCx Monitor provides setup options to customize the
testing procedures and requirements. These standards promote good
laboratory practices for operators.

Since the steps to review or change setup options are similar, the two
sub-menus are combined in one section. Any operator can review the
setup information; only an administrator (manager) with the password
can change the setup information.

The Review Setup feature enables an operator to review only the
settings for Test Setup, System Setup, System Status and Date and
Time.

The Change Setup feature enables an administrator to review or change
the settings for Test Setup, System Setup, System Status, Date and
Time, and Edit Lists.

The Test Setup menu includes: All Tests, Patient Test, Control Test,
Security and Test Type.

The System Setup menu defines the look or appearance of the data as
it is displayed on the monitor, such as language and formats. The menu
includes: language, beeper on/off, date format, time format, set
password and restore defaults.

The System Status menu allows a review of the current status of the
monitor's operating system: battery power, temperature, memory gauge
and software version.

The Date and Time menu displays the current date and time.
The Edit Lists menu changes the approved Operator ID or Test Strip

Lot lists.
The Precision PCx Menu Tree on the following page will outline the

above menus and the sub-menus.

Questions? Refer to Page 10-13 For Customer Care Information.

8-1

Review / Change Setup

8

8-2

Precision PCx Menu Tree

Test Mode

Patient

Test

Control

Test

Menu Mode

1. Data Review

2. Proficiency Test

3. Linearity Test

4. Review / 5.Change
Setup

Upload

Inter

val

Operator ID Format
Patient ID Format

Comment Code
Memory Full

Results Format
Comment Code
Memory Full

QC Interval
Operator ID
Strip Lot

Glucose

Units
Sample Type
Action Range

1. Patient History
sort by:

2. Control History

3. Proficiency Data

4. Linearity Data

1. Test Setup

2. System Setup

3. System Status

4. Date and Time

All T ests
Patient ID
Operator ID
Action Range
Comment Code
Date

All T ests
Operator ID
Outside Range
Comment Code
Date

1. All Tests

2. Patient Test

3. Control Test

4. Security

5. Test Type

1. Operator List

5. Edit Lists

Add
Delete
Change

Add
Delete
Change

sort by:

2. Strip Lot
List

1.

2.

Battery Power
Temperature
Memory Gauge
Software Version

Language
Beeper On/Off
Date Format
Time Format
Password
Factory Settings

Levels

Moving Around the Review/Change Setup Menu

The Review and Change Setup menu options offer the same additional
sub-menus (as shown in the Precision PCx Menu Tree). The operators
may have to select additional options to access the desired change or
review option.

To access these sub-menus or options in both the Review and Change
Setup menus, the message 1-Next appears at the bottom of the display.
The operator presses 1 to move to the next option. The monitor also
allows the operator to go back to the previous option by pressing Clear.
The current status or selection for the option appears in bold type on the
display .

To change an option, the administrator must access the Change Setup
menu (this is password protected). In addition to the 1-Next message
that appears at the bottom of the option screen, there is the 2-Change
message. The administrator presses 2 to change the option. The active
selection for the option now appears in bold type.

When finished reviewing or changing the options, the operator or
administrator can press Menu once to return to the beginning of Menu
Mode or press Menu twice to go to Test Mode.

In this section the majority of the directions refer specifically to how to
change various settings. However, these same directions can be
followed as well for reviewing settings under its own menu option.

Differentiation is made between the password protected sections in the
Change Setup Menu Option, where only administrators can access the
screens, and the non-password protected sections in the Review Setup
Menu Option, where operators and administrators can access
the screens.

Questions? Refer to Page 10-13 For Customer Care Information.

8-3

What You See
on the Display

What You Do Comments

8-4

Review Setup:

If the monitor displays a message not indicated in these procedures,
please refer to section 10, Troubleshooting.

Use the following steps to access the Review Setup menu:

1. Press On/Off to turn

on the monitor.

The Abbott logo screen
will appear for a few
seconds followed by the
product name, the
software version screen
and then the Test Mode
menu.

2. Press Menu. The Menu Mode menu

will appear.

3. Press 4 for Review

Setup.

The Review Setup Menu
will appear.

The operator can review
Test Setup, System Setup,
System Status and Date
and Time by following the
appropriate steps for these
procedures.

Questions? Refer to Page 10-13 For Customer Care Information.

8-5

What You See
on the Display

What You Do Comments

Change Setup:

If the monitor displays a message not indicated in these procedures,
please refer to section 10, Troubleshooting.

Use these steps to access the Change Setup menu:

1. Press On/Off to turn on

the monitor.

The Abbott logo screen
will appear for a few
seconds followed by the
product name, the
software version screen
and then the Test Mode
menu.

3. Press 5 for Change

Setup.

The display prompts the
operator to enter a
password of up to 8
characters. The password
is displayed as asterisks
on the monitor.

4. Key in the password,
then press Enter. If the
password is entered
incorrectly, the monitor
displays error message:
“Incorrect Password.”
Press Clear twice,
verify the password
then re-enter the correct
password and press

Enter.

The factory set password
is 123. Once in the
Change Setup Mode, it
is suggested that the
administrator change
the password. This can
be done in the System
Setup/Set Password
option.

2. Press Menu. The Menu Mode menu

will appear.

What You See
on the Display

What You Do Comments

8-6

The administrator can
change Test Setup,
System Setup, System
Status, Date and Time and
Edit Lists by following
the appropriate steps for
these procedures.

Questions? Refer to Page 10-13 For Customer Care Information.

8-7

Review/Change Setup for Test Setup

The Review/Change Setup menus enable the operator to review/change
the test settings.

Under the Test Setup Menu, the following options can be viewed or
changed:

• All Tests

• Patient Test

• Control Test

• Security

• Test Type
In the All Tests menu, the following options can be viewed or changed:

• Upload Interval for sending stored data to other systems.

• Establish Operator ID requirements and barcode format.
In the Patient Test menu, the following options can be viewed or

changed:

• Establish Patient ID requirements and barcode format.

• Set the requirement for out-of-range and/or in-range comment codes.

• Management of memory full overwrite.
In the Control Test menu, the following options can be viewed or

changed:

• Enable high, normal and/or low control testing.

• Control test results presented as numeric or Pass/Fail.

• Set the requirement for in-range and/or out-of-range comment codes.

• Management of memory full overwrite.
In the Security menu, the following options can be viewed or changed:

• Set QC interval requirements.

• Set requirements to prevent testing by non-certified operators.

• Set requirements to prevent testing using test strip lots that have not
been qualified for use.

In the Test Type menu, the following options can be viewed or
changed:

• Set units of measurement.

• Set sample type prompts.

• Set action ranges. The action range can also be changed in
QC Manager. Refer to the QC Manager Operator’s Manual for more
information. Note: Default action range is 20-600.

8-8

Review/Change Test Setup for All Tests:

The options that are associated with the Review/Change Test Setup
for All Tests apply to all test types.

Use this menu to review or change these options for all tests.

Upload Interval

The monitor can be set up to warn or lockout a task if the monitor has
not been uploaded at a regularly scheduled interval. The upload interval
options are:

• Allow Test–allows the testing to continue. No message will appear
on the monitor.

• Warn–allows the testing to continue but the operator will receive a
message that the upload interval (as specified below) has expired.

• Lockout–does not allow any testing until the data has been uploaded.
This option is set to designate a required maximum number of hours
or days (from 1 to 99) between data uploads. When a task is selected
and the upload interval has expired, the operator will receive a
message that the Upload Interval has expired. If Upload Interval is
expired, the monitor will prevent an operator from doing other tasks
until the stored data is uploaded.

Operator ID

The Operator ID menu has the following options which can be viewed
or changed:

• Disabled, Optional or Required entry of an Operator ID for all testing.

• Require a minimum and a maximum number of digits for the length
of an Operator ID.

• Allow any combination of five common barcode formats used in
the facility:

I2 of 5 (with or without check digit)
Code 39 (with or without check digit, alphanumeric or

ASCII format)
Code 128
Codabar
Code 93

• Truncate (ignore) leading and/or trailing barcode digits.

Note: The display shows selected options in bold type.

Questions? Refer to Page 10-13 For Customer Care Information.

8-9

What You See
on the Display

What You Do Comments

1. Press 1 for Test Setup. The display shows the

Test Setup menu.

2. Press 1 for All Tests. The display shows the

Upload Interval menu.

3. The administrator will

select one of the
following options:

Press 1 – Next; skip
forward to step 8.

Press 2 – Change.

The display shows the
current settings in bold. If
2 is pressed, the display
shows the Upload Interval
options.

4. The administrator will

select one of the
following options:

Press 1 – Allow T est; skip
forward to step 7.

Press 2 – Warn.
Press 3 – Lockout.

If 2 or 3 is pressed, the
display will show the
upload interval hours
and days option.

5. The administrator will

select one of the
following options:

Press 1 – Hours.
Press 2 – Days.

The display prompts for
the number of days/hours
to be entered.

Review/Change Setup for All Tests:

Refer to the beginning of the Review/Change Setup Section for step-by­step instruction to access the appropriate setup menu.

If the monitor displays a message not indicated in these procedures,
please refer to section 10, Troubleshooting.

What You See
on the Display

What You Do Comments

8-10

6. Enter 1-99 hours or

1-99 days then press

Enter.

The All Tests Upload
Interval screen will be
displayed.

7. Press 1 to continue to

the All Tests Operator
ID screen.

The display shows the All
Tests Operator ID menu.

8. The administrator will

select one of the
following options:

Press 1 – Next, return to
the Test Setup menu.

Press 2 – Change.

The display shows the
Operator ID options.

9. The administrator will

select one of the
following options:

Press 1 – Disabled; skip
forward to step 13.

Press 2 – Optional.
Press 3 – Required.

If Disabled is selected, the
display will not prompt
for Operator ID. If
Optional or Required is
selected, the administrator
can enter a minimum and
maximum number of
digits, between 1-15
digits.

10. The administrator will

enter minimum and
maximum numbers
between 1-15.

Key in the minimum
number of digits for an
operator ID then press

Enter.

Key in the maximum
number of digits for an
operator ID then press

Enter.

The display shows the
Operator ID Barcode
options.

Questions? Refer to Page 10-13 For Customer Care Information.

8-11

What You See
on the Display

What You Do Comments

11. The administrator may
customize I2 of 5 by
pressing 1 if I2 of 5
is bolded (enabled).
Press 1 again to access
the Operator ID
Barcode screen.

Activated barcodes appear
in bold type. More than
one Barcode format can
be active at one time.
Any Barcode can be
deactivated by selecting
the corresponding number.

Note: Only Barcodes
1 and 2 can be
customized.

12. The administrator will

select one of the
following:

1. No Check Digit

2. USS Check Digit

3. OPCC Check Digit

The display returns to
the Operator ID Barcode
screen.

USS or OPCC will
appear after the format,
if selected.

13. The administrator may
customize Code 39 by
pressing 2 if Code 39
is bolded (enabled).
Press 2 again to access
the Operator ID
Barcode screen.

14. The administrator will
select one of the
following:

1. No Check Digit

2. Use Check Digit

The display shows the
Alphanumeric, Full ASCII
screen.

15. The administrator will
select one of the
following:

1. Alphanumeric

2. Full ASCII

The display returns to
the Operator ID Barcode
screen.

C will appear after the
format if Check Digit is
selected.

F will appear if Full
ASCII is selected.

8-12

17. Press Enter twice

for no truncation of
leading or trailing
digits; otherwise enter
the number of leading
and trailing barcode
digits to truncate
(ignore).

The monitor can be set to
ignore a specific number
of leading and/or trailing
barcode digits.

The display returns to the
All Tests, Operator ID
screen.

18. The administrator will

select one of the
following options:

Press 1 – Next, return to
the Test Setup menu.

Press Menu to return to
the Menu Mode.

Press On/Off to turn off
the monitor.

What You See
on the Display

What You Do Comments

16. To access the Truncate
Digits screen, press 6
and continue forward
to step 17.

The display shows the
Operator ID Barcode
Truncate Digits screen.

Questions? Refer to Page 10-13 For Customer Care Information.

8-13

Review/Change Test Setup for Patient Test:

The options set with this menu will apply to all Patient Tests.
The Patient ID option uses a patient identification number to perform

tests. Patient ID uses the following options:

• Disable, Require or make Optional the entry of a Patient ID.

• Require a minimum and maximum number of digits for the length
of the Patient ID.

• Allow any combination of five common barcode formats used in
the facility.

I2 of 5 (with or without check digit)
Code 39 (with or without check digit, alphanumeric or

ASCII format)
Code 128
Codabar
Code 93

• Truncate (ignore) leading and/or trailing barcode digits.

Comment Code option allows the following to be selected:

• Disable the prompt for a Comment Code.

• Prompt for a Comment Code with the option of not requiring it.

• Require a Comment Code for every test result out-of-range and/or
in-range of the action range. (See Test Type setup options).

The Memory Full option will notify the operator that the patient test
memory has reached its limit (4000 tests that have not been uploaded).
Memory Full provides the following options:

• Lockout additional tests until the data is uploaded.

• Prompt the operator to upload data before overwriting old test
results with new ones.

• Automatically overwrite oldest test results with new ones.

8-14

Review/Change Test Setup for Patient Test:

Refer to the beginning of the Review or Change Setup section for
step-by-step instructions to access the appropriate setup menu.

If the monitor displays a message not indicated in these procedures,
please refer to section 10, Troubleshooting.

What You See
on the Display

What You Do Comments

1. Press 1 – Test Setup. The display shows the

Test Setup menu.

2. Press 2 – Patient Test. The display shows the

Patient Test, Patient ID
Barcode screen.

3. The administrator will

select one of the
following options:

Press 1 –

Next; skip

forward to step 14.
Press 2

– Change; to

change Patient ID.

The display shows the
Patient ID options.

4. The administrator will

select one of the
following options:

Press 1 –

Disabled;
(returns to the previous
screen).

Press 2

– Optional.

Press 3 – Required.

If Disabled is selected, the
display will not prompt
for Patient ID. If Optional
or Required is selected,
the operator can enter a
minimum and maximum
number of digits, between
1-15 digits.

Questions? Refer to Page 10-13 For Customer Care Information.

8-15

What You See
on the Display

What You Do Comments

5. The administrator will

enter minimum and
maximum numbers
between 1-15.

Key in the minimum
number of digits for a
Patient ID number then
press Enter .

Key in the maximum
number of digits for a
Patient ID number then
press Enter .

The display returns to the
Patient Test, Patient ID
Barcode Menu.

6. The administrator may
customize I2 of 5 by
pressing 1 if I2 of 5 is

bolded (enabled). Press
1 again to access the

Patient ID Barcode
screen.

Activated barcodes appear
in bold type. More than
one Barcode format can be
active at one time. Any
Barcode can be
deactivated by selecting
the corresponding number.

Note: Only Barcodes
1 and 2 can be customized.

7. The administrator will

select one of the
following:

1. No Check Digit

2. USS Check Digit

3. OPCC Check Digit

The display returns to the
Patient ID Barcode
screen.

USS or OPCC will
appear after the format,
if selected.

8. The administrator may
customize Code 39 by
pressing 2 if Code 39 is
bolded (enabled). Press
2 again to access the
Patient ID Barcode
screen.

9. The administrator will

select one of the
following:

1. No Check Digit

2. Use Check Digit

The display shows the
Alphanumeric, Full ASCII
screen.

8-16

What You See
on the Display

What You Do Comments

12. Press Enter twice

for no truncation of
leading or trailing
digits; otherwise enter
the number of leading
and trailing barcode
digits to truncate
(ignore).

The monitor can be set to
ignore a specific number
of leading and/or trailing
barcode digits.

The display returns to the
Patient Test, Patient ID
Barcode screen.

13. Press 1 – Next;

continue to the next
menu.

The display shows the In­Range Comment Code
screen.

14. The administrator will

select one of the
following options:

Press 1 – Next, and
continue to step 17.

Press 2 – Change, to
change the In-Range
Comment Code.

The display shows the
In-Range Comment Code
options. The Comment
Code options can be set
to Disabled, Optional or
Required for test results
that fall in the action
range.

10. Select one of the

following:

1. Alphanumeric

2. Full ASCII

The display returns to
the Patient ID Barcode
screen.

C will appear after the
format if Check Digit is
selected.

F will appear if Full
ASCII is selected.

11. To access the Truncate

Digits screen, press 6
and continue forward
to step 12.

The display shows the
Patient ID Barcode
Truncate Digits screen.

Questions? Refer to Page 10-13 For Customer Care Information.

8-17

15. The administrator will

select one of the
following options:

Press 1 – Disabled.
Press 2 – Optional.
Press 3 – Required.

The display is returned to
the Patient Test Comment
Code If In-Range screen.

16. Press 1 – Next;

continue to the next
menu.

The display shows the
Out-of-Range Comment
Code menu. The comment
code options can be set to
Disabled, Optional or
Required for test results
that fall outside the action
range.

What You See
on the Display

What You Do Comments

17. The administrator will

select one of the
following options:
Press 1 –

Next, and

continue to step 20.
Press 2

– Change, to

change the Out-of­Range Comment
Code.

The display shows the
Out-of-Range Comment
Code options.

18. The administrator will

select one of the
following options:

Press 1 – Disabled.
Press 2 – Optional.
Press 3 – Required.

The display shows the
Patient Test Comment
Code If Out-of-Range
screen.

8-18

What You See
on the Display

What You Do Comments

19. Press 1 – Next;

continue to the next
menu.

The display shows the
Memory Full screen.

20. The administrator will

select one of the
following:

Press 1 – Next, and
continue to next menu.
Press 2 – Change, to
change Memory Full
option.

The display shows the
Memory Full options.
Once the Patient Test
storage bank is full, the
following can be set by
the monitor: lockout
additional tests; prompt
for overwrite option; or
automatically overwrite
the oldest stored tests.

21. The administrator will

select one of the
following options:

Press 1 – Allow
Overwrite.

Press 2 – Prompt for
Overwrite.

Press 3 – Lockout.

The display is returned to
the Patient Test Memory
Full screen.

22. The administrator will

select one of the
following options:

Press 1 to return to Test
Setup menu.

Press Menu to return to
the Menu Mode.

Press On/Off to turn off
the monitor.

Questions? Refer to Page 10-13 For Customer Care Information.

8-19

Review/Change Test Setup for Control Tests

The options associated with this menu apply to all Control Tests.
Control levels can be any combination of low, normal, and high.

At least one level must be selected.
The Results Format has the following options:

Show test results in a Numeric or Pass/Fail format.
Comment Code prompts have the following options:

• Disable the prompt for a comment code

• Prompt for a comment code with the option of not requiring it

• Require a comment code for every in-range and/or out-of-range test
result.

The Memory Full option can notify the operator that the control test
memory has reached its limit (1000 tests that have not been uploaded).
Memory Full has the following options:

• Lockout additional tests until data is uploaded

• Prompt to overwrite old test results with new ones

• Automatically overwrite oldest test results with new ones.

8-20

Review/Change Test Setup for Control Tests:

Refer to the beginning of the Review or Change Setup section for step­by-step instructions to access the appropriate setup menu.

If the monitor displays a message not indicated in these procedures,
please refer to section 10, Troubleshooting.

What You See
on the Display

What You Do Comments

1. Press 1 – Test Setup. The display shows the

Test Setup menu.

2. Press 3 – Control Test. The display shows the

Control Test Lev e l s screen.
The monitor can be set to
perform any combination
of low, normal and high
control tests.

3. The administrator will

select one of the
following options:

Press 1 – Next, to review
Control Test Result; skip
forward to step 6.

Press 2 – Change, to
change Control Test
Levels option.

The display shows the
Control Test Levels
options.

4. The administrator will

select one or a
combination of the
following options:

Press 1 – Low, to activate
low control.

Press 2 – Normal, to
activate normal control.

Press 3 – High, to activate
high control.

Press 4 – to return to
Control Test Levels screen.

The activated control
level(s) are in bold type.

Questions? Refer to Page 10-13 For Customer Care Information.

8-21

What You See
on the Display

What You Do Comments

5. Press 1 – Next, to

continue to the Control
Test Result menu.

The display shows
the Control Test Result
option. The control
test results can be set
to appear as numeric
or Pass/Fail.

6. The administrator will

select one of the
following options:

Press 1 – Next, to review
In-Range Comment Code;
skip forward to step 9.

Press 2 – Change, to
change the result to
Numeric or Pass/Fail.

The display shows the
Control Test Result menu.

Pass/Fail indicates
whether the control test
result is in-range or out­of-range.

7. The administrator will

select one of the
following options:

Press 1 – Numeric.
Press 2 – Pass/Fail.

The display is returned
to the Control Test Result
menu.

8. Press 1 – Next. The display shows the

Control Test Comment
Code If In-Range screen.

9. The administrator will

select one of the
following options:

Press 1 – Next, to
continue to Control Test
Comment Code If Out-of­Range menu. Skip
forward to step 12.

Press 2 – Change, to
change the In-Range
Comment Code option.

The display shows the
Comment Code If In­Range options.

8-22

What You See
on the Display

What You Do Comments

10. The administrator will

select one of the
following options:

Press 1 – Disabled.
Press 2 – Optional.
Press 3 – Required.

The display returns
to the Control Test
Comment Code If In­Range screen.

11. Press 1 to continue to

the next option.

The display shows the
Control Test Comment
Code If Out-of-Range
screen.

12. The administrator will

select one of the
following options:

Press 1 – Next, to continue
to Memory Full menu.
Skip forward to step 15.

Press 2 – Change, to
change the Comment
Code If Out-of-Range
options.

The display shows the
Comment Code If Out­of-Range options.

13. The administrator will

select one of the
following options:

Press 1 – Disabled.
Press 2 – Optional.
Press 3 – Required.

The display returns
to the Control Test
Comment Code If
Out-of-Range screen.

14. Press 1 – Next, to

continue to the
Memory Full menu.

The display shows the
Control Test Memory Full
options.

Questions? Refer to Page 10-13 For Customer Care Information.

8-23

What You See
on the Display

What You Do Comments

15. The administrator will

select one of the
following options:

Press 1 – Next, return to
the Test Setup menu.

Press 2 – Change, change
the Memory Full options.

Allow Overwrite will
automatically overwrite
the existing data. Prompt
for Overwrite will notify
the operator that the data
will be overwritten, giving
the operator the choice to
overwrite the data or not.
Lockout will lockout the
operator from overwriting
any data until the data has
been uploaded.

16. The administrator will

select one of the
following options:

Press 1 – Allow
Overwrite.

Press 2 – Prompt for
Overwrite.

Press 3 – Lockout.

The display is returned to
the Control Test Memory
Full screen.

17. The administrator will

select one of the
following options:

Press 1 – Next, return to
Test Setup menu.

Press Menu to return to
the Menu Mode.

Press On/Off to turn off
the monitor.

8-24

Review/Change Test Setup for Security

The Test Setup for Security menu enables the monitor to establish that
certain criteria be met before a test can be performed.

• In all situations, the monitor can be set to Allow Test (allow the
operator to test), Warn (tell the operator about the situation and
still test) or Lockout (no testing can be done).

• QC Interval can require control tests to be run at certain time
intervals. For example, every 12 hours, at specified times (7 a.m.,
3 p.m. and 11 p.m.), or after a specified number of patient tests
(1-250).

• The Operator ID can require that the operator ID is on the list of
qualified/certified operators to continue.

• The Strip Lot (Test Strip Lot) can require that the test strip lot
is on the list of qualified test strip lots to continue.

Questions? Refer to Page 10-13 For Customer Care Information.

8-25

Review/Change Test Setup for Security:

Refer to the beginning of the Review or Change Setup section for the
step-by-step instructions to access the appropriate setup menu.

If the monitor displays a message not indicated in these procedures,
please refer to section 10, Troubleshooting.

What You See
on the Display

What You Do Comments

1. Press 1 – Test Setup. The display shows the

Test Setup menu.

2. Press 4 – Security. The display shows the

Security QC Interval
menu.

3. The administrator will

select one of the
following options:

Press 1 – Next, to
continue to Security
Operator ID Not Certified
screen and skip forward to
step 10.

Press 2 – Change, to
change the QC Interval
Controls Expired option.

The display shows the
options for the QC
Interval Controls Expired
menu. The options are to
Allow Test, even if the
QC interval has expired;
Warn the operator that
even though the QC
interval has expired, the
test may continue; or
Lockout the system until
the required control tests
are performed.

8-26

What You See
on the Display

What You Do Comments

4. The administrator will

select one of the
following options:

Press 1 – Allow T est.
Press 2 – Warn.
Press 3 – Lockout.

The display shows
the QC Interval Security
menu. The operator can
choose between QC
intervals. The settings
are:

• Time Interval – QC
Interval based on a set
number of hours
between control tests.

• Time of Day – choose
up to three times
during the day that QC
Interval will take place.

• Number of Patient
Tests – QC Interval
based on the number
of patient tests
specified.

5. The administrator will

select one of the
following options:

Press 1 – Time Interval:
continue to step 6.

Press 2 – Time of Day:
skip to step 7.

Press 3 – Patient Tests:
skip to step 8.

QC Time Interval option,
the Time of Day option,
or the Number of Patient
Tests option.

6. Enter a Time Interval

number between 1-99,
then press Enter. Skip
forward to step 9.

The display returns to
the Security QC Interval
menu.

7. Enter up to 3 times

of the day in
chronological order,
starting at midnight.
Press Enter to confirm
each time. Skip forward
to step 9.

The display returns to
the Security QC Interval
menu.

Questions? Refer to Page 10-13 For Customer Care Information.

8-27

What You See
on the Display

What You Do Comments

10. The administrator will

select one of the
following options:

Press 1 – Next, to
continue; skip forward
to step 13.

Press 2 – Change, to
change Operator ID
Security.

The display shows the
Operator ID Not Certified
options.

11. The administrator will

select one of the
following options:

Press 1 – Allow T est.
Press 2 – Warn.
Press 3 – Lockout.

The display is returned to
the Security Operator ID
Not Certified screen.

12. Press 1 to continue to

the Security Strip Lot
Not on List screen.

The display shows the
Security Strip Lot Not
on List screen.

9. Press 1 to continue to

the Security Operator
ID Not Certified screen.

The display shows the
Security Operator ID Not
Certified screen.

8. Enter number of patient

tests between 1-250,
then press Enter.

The display returns to
the Security QC Interval
menu.

8-28

What You See
on the Display

What You Do Comments

15. The administrator will

select one of the
following options:

Press 1 to return to the
Test Setup menu.

Press Menu to return
to the Menu Mode.

Press On/Off to turn off
the monitor.

14. The administrator will

select one of the
following options:

Press 1 – Allow T est.
Press 2 – Warn.
Press 3 – Lockout.

The display returns to the
Security Strip Lot Not on
List screen.

13. The administrator will

select one of the
following options:

Press 1 – Next, to return
to the Test Setup menu.

Press 2 – Change, to
change the Strip Lot
Not on List options.

The display shows the
Strip Lot Not on List
options.

1.Allow Test – a test strip

lot not on the test strip
lot list.

2.Warn – the test strip lot

is not on the test strip
lot list (operator may
continue with test).

3.Lockout – a test

strip lot that is not
on the test strip lot
list (operator may
not continue).

Review/Change Test Setup for Test Type

The options set with the Review/Change Test Setup for Test Type apply
to different tests that may be performed, such as glucose. Use this menu
to review or change these setups for Test Type:

Units:

Display test results in certain measurement units. The options are:

• mg/dL

• mmol/L

Sample T ype:

Distinguish between different types of blood samples used for patient
tests. The options are:

• Prompt to select the blood sample type for each patient test.

• Default to Capillary or Arterial for all patient tests.

• Default to Venous for all patient tests.

Action Range:

Set the range (low and high) when action should be taken based on the
patient result obtained. The options are:

• Disable the action range.

• Enable and set the action range.

Questions? Refer to Page 10-13 For Customer Care Information.

8-29

8-30

What You See
on the Display

What You Do Comments

Review/Change Test Setup for Test Type:

Refer to the beginning of the Review or Change Setup section for the
step-by-step instructions to access the appropriate setup menu.

If the monitor displays a message not indicated in these procedures,
please refer to section 10, Troubleshooting.

1. Press 1 – Test Setup. The display shows

the Test Setup menu.

2. Press 5 – Test Type. The display shows the

Test Setup, Test Type
menu.

3. Press 1 to continue to

Glucose Units option.

The display shows the
Glucose Units screen.

4. The administrator will

select one of the
following options:

Press 1 – Next, to
continue to Glucose
Sample Type menu; skip
forward to step 7.

Press 2 – Change, to
change the test
measurement units.

The display shows the
Units options.

Questions? Refer to Page 10-13 For Customer Care Information.

8-31

What You See
on the Display

What You Do Comments

5. Choose one of the

following options:

Press 1 – mg/dL.
Press 2 – mmol/L.

The display is returned
to the Glucose Units
screen.

6. Press 1 to continue

to the next menu.

The display shows the
Glucose Sample Type
screen.

7. The administrator will

select one of the
following options:

Press 1 – Next, to
continue to Glucose
Action Range menu; skip
forward to step 10.

Press 2 – Change, to
change Sample Type
prompt.

The display shows the
Sample Type options.

8. The administrator will

select one of the
following options:

Press 1 – Prompt.
Press 2 – Capillary or

Arterial.
Press 3 – Venous.

The monitor can be set to
always prompt for the
sample type or to always
default to either Capillary
or Arterial, or Venous
blood samples.

The display is returned to
the Glucose Sample Type
screen.

9. Press 1 to continue to

the Glucose Action
Range menu.

The display shows the
Glucose Action Range
screen.

(1.1 mmol/L,

-27.8 mmol/L)

Precision PCx Plus Test Strip

8-32

What You See
on the Display

What You Do Comments

10. The administrator will

select one of the
following options:

Press 1 – Next, to return
to Test Setup Test Type.

Press 2 – Change, to
change action range.

If the action range is
disabled, the display is
returned to the Test Setup
Test Type screen. If the
action range is enabled,
the display shows the
action range.

The display shows the
Glucose Action Range
options.

11. The administrator will

select one of the
following options:

Press 1 – Disabled. Skip
forward to step 13.

Press 2 – Enabled.

The display shows the
Action Range screen.

When the action range
is enabled, the display
shows an Action Range
Low and High values
screen. Enter a low action
range value and a high
action range value.

13. Press 1 – Next to

return to the Test
Setup Test Type
Screen.

12. Enter the low value
and press Enter.
Enter the high value
and press Enter.

The display is returned to
the Glucose Action Range
screen.

Refer to test strip
instructions for use for
Action Range.

(1.1 mmol/L,

-33.3 mmol/L)

Precision PCx Test Strip

Questions? Refer to Page 10-13 For Customer Care Information.

8-33

What You See
on the Display

What You Do Comments

14. The administrator will

select one of the
following options:

Press Clear to return to
Test Setup menu.

Press Menu to return to
the Menu Mode menu.

Press On/Off to turn off
the monitor.

8-34

Review/Change Setup for System Setup

System Setup enables the look or appearance of the data shown on the
display to be customized. The monitor can be formatted to present
information in a way that is more comfortable or familiar to work with.
Use this menu to review or change the setup for these features:

Language

This option presents the data in English or another language.

Beeper

This option turns the monitor beeper on or off. (The monitor beeps
to alert the operator of certain functions).

Date Format

This option presents the date in mm/dd/yy, dd/mm/yy, or yy/mm/dd
format. The user can select the punctuation that separates month,
day and year.

Time Format

This option presents time in a 12 or 24-hour clock and separates
numbers with different punctuation.

Set Password

This option allows the password to be changed.

Restore Defaults

This option restores the monitor to factory settings.

Questions? Refer to Page 10-13 For Customer Care Information.

8-35

What You See
on the Display

What You Do Comments

Review/Change Setup for System Setup:

Refer to the beginning of the Review or Change Setup section for the
step-by-step instructions to access the appropriate setup menu.

If the monitor displays a message not indicated in these procedures,
please refer to section 10, Troubleshooting.

1. Press 2 – System Setup. The display shows the

System Setup Language
menu.

2. The administrator will

select one of the
following:

Press 1 – Next, to
continue to System Setup
Beeper menu; skip
forward to step 5.

Press 2 – Change, to
change the language.

The display shows the
Language setup options.

3. The administrator will

select the appropriate
language.

The display returns to the
System Setup Language
menu.

4. Press 1 – Next, to go to

System Setup Beeper.

The display shows the
System Setup Beeper
menu.

5. The administrator will

select one of the
following options:

Press 1 – Next, to go to
System Setup Date
Format menu; skip
forward to step 8.

Press 2 – Change, to
change the beeper setting.

The display shows the
Beeper option.

8-36

What You See
on the Display

What You Do Comments

6. The administrator will

select one of the
following options:

Press 1 – Enabled.
Press 2 – Disabled.

The display returns to
the System Setup Beeper
menu.

7. Press 1 – Next. The display shows the

System Setup Date
Format menu.

8. The administrator will

select one of the
following options:

Press 1 – Next, to
continue to System Setup
Time Format menu. Skip
forward to step 12.

Press 2 – Change, to
change the Date Format
option.

The display shows the
Date Format options. The
date is listed using 2
digits for the month, day
and year. For example,
June 27, 1999 becomes
06 27 99.

9. The administrator will

select one of the
following options:

Press 1 – month/day/year.
Press 2 – day/month/year.
Press 3 – year/month/day.

The display shows the
Date Format Separator
options.

The numbers can be
separated with a slash (/),
dash (-), period (.) or no
punctuation.

10. The administrator will

select one of the
following options:

Press 1 – slash (/).
Press 2 – dash (-).
Press 3 – period (.).
Press 4 – none.

The display is returned to
the System Setup Date
Format menu.

Questions? Refer to Page 10-13 For Customer Care Information.

8-37

What You See
on the Display

What You Do Comments

11. Press 1 to continue to

System Setup Time
Format menu.

The display shows the
System Setup Time
Format menu.

12. The administrator will

select one of the
following options:

Press 1 – Next, to
continue to System Setup
Password; skip forward
to step 19.

Press 2 – Change, to
change the Time Format.

The display shows the
Time Format options. The
four options to use are: 12
hour clock using capital
AM/PM; 12 hour clock
using lowercase am/pm; a
0-24 hour clock; and a
01-24 hour clock.

13. The administrator will

select one of the
following options:

Press 1 – 1-12 AM/PM.
Press 2 – 1-12 am/pm.

The display shows the
Time Format Separator
screen for hours. The 5
options are separators for
hours.

14. The administrator will

select one of the
following options:

Press 1 – colon (:).
Press 2 – period (.).
Press 3 – h.
Press 4 – H.
Press 5 – none.

The display returns to the
System Setup Time
Format screen.

15. If the administrator

selects one of the
following options:

Press 3 – 0-23.
Press 4 – 00-23.

The display shows the
Time Format Separator
screen for hours. The 5
options are separators for
hours.

8-38

What You See
on the Display

What You Do Comments

18. Press 1 to continue to

System Setup
Password.

The display shows the
System Setup Password
screen.

19. The administrator will

select one of the
following options:

Press 1 – Next, to
continue to the System
Setup Change all settings
to Factory Defaults menu.
Skip forward to step 24.

Press 2 – Change, to
change the Password.

The display will prompt
the operator to enter the
current Password.

20. Enter the current

Password, up to 8
digits, then press

Enter.

The display prompts the
operator to enter a New
Password.

16. The administrator will
select one of the
following options:

Press 1 – colon (:).
Press 2 – period (.).
Press 3 – h.
Press 4 – H.
Press 5 – none.

The display shows the
Time Format Units screen
for minutes. The 4 options
are separators for minutes.

17. The administrator will
select one of the
following options:

Press 1 – m.
Press 2 – apostrophe (‘).
Press 3 – h.
Press 4 – none.

The display returns to the
System Setup Time
Format screen.

Questions? Refer to Page 10-13 For Customer Care Information.

8-39

21. Enter the New

Password, then press

Enter.

The display asks the
operator to re-enter the
password to confirm the
New Password, then press

Enter.

22. Re-enter New

Password; press Enter
to confirm.

The display returns to the
System Setup Password
menu.

23. Press 1 to continue to

System Setup Change
all settings to Factory
Defaults menu.

The display shows the
System Setup Change all
settings to Factory
Defaults menu.

What You See
on the Display

What You Do Comments

24. The administrator will

select one of the
following options:

Press 1 – Next, to return
to Change Setup menu.

Press 2 – Change, to
change all settings to
Factory Defaults.

The display shows the
Confirm options.

25. The administrator will

select one of the
following options:

Press 1 – Change to
Factory Defaults.

Press 2 – Don't Change.

The display is returned to
the System Setup Change
all settings to Factory
Defaults menu.

26. The administrator will

select one of the
following options:

Press 1 to return to
Change Setup menu.

Press Menu to return to
the Menu Mode.

Press On/Off to turn off
the monitor.

8-40

Review/Change Setup for System Status

The Review/Change Setup menu allows the operator or administrator to
review important information about the monitor operating status. The
operator scrolls through the various screens, in the order they are listed
below, by pressing 1

– Next.

Battery Power

This option checks the amount of battery power available for a
rechargeable or disposable battery.

Temperature

This option measures the current temperature of the area where the
monitor is.

Memory

This option indicates the percentages of memory available for Patient
Test results and Control Test results.

Software Version

This option displays the software version in the monitor.