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Table of Contents
Section 1 Introduction .............................................................................. 1
Intended Use ............................................................................................ 1
About Prothrombin Time (PT) Testing ...................................................... 2
About International Normalized Ratio (INR) Values ................................. 2
Test Principle ............................................................................................ 2
Section 2 System Components ............................................................... 4
Component Descriptions: ......................................................................... 5
Mission® PT/INR Meter ............................................................................ 6
Mission® PT/INR Test Strip ....................................................................... 6
Code Chip ................................................................................................ 6
Meter Display ........................................................................................... 7
Section 4 Initial Setup .............................................................................. 9
Code # ..................................................................................................... 9
Section 5 Meter Setup and Options .......................................................11
Memory Review ...................................................................................... 11
Deleting Stored Readings ....................................................................... 11
Setting the Display Contrast ................................................................... 12
Setting the Date ..................................................................................... 12
Setting the Time ..................................................................................... 13
Sound ..................................................................................................... 15
Meter Information ................................................................................... 15
Display Language .................................................................................. 16
INR Display ............................................................................................ 16
Password ............................................................................................... 17
Section 6 Testing .................................................................................... 19
Fingertip Testing (For Professional and Self-Testing Use) ..................... 19
Specimen Collection............................................................................... 23
Optional Testing Methods ....................................................................... 26
Venous Blood Testing (For Professional Use Only) ................................ 27
Section 7 Quality Control ....................................................................... 28
Electronic Calibrator ............................................................................... 28
Liquid Control Test ................................................................................. 30
Section 8 Maintenance ........................................................................... 34
Replacing the Batteries .......................................................................... 34
Disinfection Process ............................................................................... 35
General Maintenance ............................................................................. 36
Section 9 Precautions ............................................................................ 38
Meter Use and Precautions .................................................................... 38
Test Strip Use and Precautions .............................................................. 39
Section 10 Troubleshooting ................................................................... 40
Appendix 1 Meter Specifications........................................................... 42
Appendix 2 Index of Symbols ................................................................ 43
Appendix 3 Warranty .............................................................................. 47
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Section 1 Introduction
Intended Use
The Mission® PT/INR Monitoring System is intended for self-testing and
professional use for the monitoring of oral anticoagulant therapy by
quantitative prothrombin time (PT) testing. The Mission® PT/INR Test Strips
work with fresh capillary or non-anticoagulated venous whole blood
specimens from patients on Coumarin-type (e.g. Warfarin) anticoagulation
therapy. The device is not intended to be used for screening purposes.
The easy-to-operate system consists of a portable meter and individual test
strips that analyze the clotting time. A programmed code chip with strip
parameters is provided with each box of strips to ensure proper coding of the
meter. The Mission® PT/INR Monitoring System provides results as
International Normalized Ratio (INR) or INR+PT values in about 2 minutes
and requires only a single drop of whole blood.
The meter can store up to 200 results and can be operated by 4 AA (1.5V)
batteries or the included AC adapter.
Note: It is required that the healthcare professional follows the Mission®
PT/INR Monitoring System Training Manual to train the self-testing
patient before the patient uses the Mission® PT/INR Monitoring
System at home. The self-testing patient must complete the
training and practice running a test on the meter with a health care
professional. To review these training files, visit ACON website
at www.aconlabs.com. Click on International Clinical Chemistry,
select PT/INR Coagulation, and then click on Download.
To ensure accurate results:
Read the instructions in the User’s Manual and complete any
necessary training before use.
Use the code chip that is included in each box of test strips.
Only use Mission
®
PT/INR Test Strips with the Mission® PT/INR Meter.
For in vitro diagnostic use only.
For self-testing and professional use.
Test with fresh fingertip capillary or venous whole blood specimens.
Verify the testing results using clinical laboratory methods before
making any adjustments to your medication, diet, or exercise routines.
Do not use accessories that are not supplied or recommended by the
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manufacturer.
Use the equipment only for the purpose described in the instructions for use.
Keep out of reach of children.
Note: Buttons on the meter are represented in this manual by text in
bold italics. Other display items on the screen are listed in
bold.
About Prothrombin Time (PT) Testing
PT testing is the standard method of monitoring patients on oral
anticoagulants. The Mission® PT/INR Monitoring System is designed to
monitor patients on oral Coumarin-type anticoagulants, such as Warfarin
(Coumadin® or Marevan®), Phenprocoumon (Marcumar®) or Acenocoumarol
(Sintrom®). These anticoagulants require regular monitoring, as many things
can interfere with or enhance their effects. These can include:
Small changes in patient dosing
Diet
Exercise
Alcohol consumption
Other medications
The Mission® PT/INR Monitoring System can report results as INR or
INR+PT values in just a few minutes by simply taking a specimen of blood
from a fingertip. This information can then be used to adjust the
anticoagulant dosage or to determine if further testing is needed.
About International Normalized Ratio (INR) Values
INR values reflect a method of converting PT test results into a common
scale that has been adopted internationally. This practice allows medical
practitioners throughout the world to report Prothrombin Time test results in
a consistent manner. The Mission® PT/INR Monitoring System displays
results as INR or INR+PT values.
Test Principle
When used as directed, the Mission® PT/INR Monitoring System will
accurately and reliably measure blood INR levels. Specimens used for
testing can either be fingertip capillary or venous whole blood and are
applied directly to the test strip.
It is a simple procedure to perform the test. Insert the code chip, which is
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provided with each box of test strips, into the slot on the meter. This
provides lot specific calibration data to the meter. Then insert a test strip into
the meter detection area under the strip holder. After a brief warm-up time,
the specimen can be added to the test strip specimen application area.
When the specimen is added, the meter detects the specimen application
and initiates the test. During the test, a reaction initiating clot formation
begins.
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Section 2 System Components
The figures below are labeled to identify the major components of the
Mission® PT/INR Monitoring System.
PT/INR Mete
r
Code Chip
Control Solution
AA Batteries
Plastic Clamp
Capillary Transfer Tube
Carrying Case
AC Adapte
r
Plug
Safety Lancet
Test Strip
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Component Descriptions:
PT/INR Meter: Reads the test strips and displays PT and INR values.
Test Strip: Single use strip with a sample application well where blood
samples or control solutions are applied. These are inserted into the meter
to measure PT and INR values.
Code Chip: Provided in each box of test strips. This provides lot specific
calibration data to the meter when inserted into the meter.
Safety Lancet: Used to draw blood specimens for testing. Discard after use.
Capillary Transfer Tube: Collects capillary blood from fingertip blood
testing for accurate results. Ensures the collection of 15 µL of specimen.
Control Solution: Two levels of predetermined ranges: Level 1 (Normal)
and Level 2 (High). They are intended for use as a quality control check to
verify that the PT/INR Monitoring System is working properly.
Plastic Clamp: Provided in each box of control solutions. Used to break the
glass ampoule inside the plastic control solution vial to release the water.
AA Batteries: Provides power for the meter.
AC Adapter: For prolonged or continuous use, an AC adapter may be used,
instead of batteries, to power the meter.
Carrying Case: Provides portability for testing and meter protection.
User’s Manual: Provides detailed instructions on using the PT/INR
Monitoring System.
Quick Reference Guide: Provides a brief overview of the PT/INR
Monitoring System and its testing procedures.
Test Strips Package Insert: Provides detailed instructions on using the
Mission
®
PT/INR Test Strips.
Control Solution Package Insert: Provides detailed instructions on using
the Mission
®
PT/INR Control Solutions.
Warranty Card: Card included in the package, which should be completed
and returned to the distributor to qualify for the 2-year meter warranty.
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Section 3 Getting Started
Mission® PT/INR Meter
Mission
®
PT/INR Test Strip
The arrows on the test strip indicate the direction to insert the strip into the
meter. The specimen well is the circular target area where the blood
specimen is applied.
Code Chip
A code chip is provided in each box of test strips. The code
chip needs to be inserted into the meter code chip slot each
time a new box of test strips is opened. The code number is
printed on the outside of the code chip.
Caution: The code chip provided with the box of strips must be used or
an incorrect INR measurement may result.
A
C Adapter
Printer Connection
Port
USB Port
Liquid Crystal
Display (LCD)
Code Chip Slot
Power Button
Code Chip
Optics Cover
Specimen Well
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Meter Display
1. Date: Shows the current date
2. Time: Shows the current time
3. Battery: Shows battery status or AC Adapter connection
4. Function Labels: Helps navigate between functions and confirm selections
5. Selection Box: Indicates which function is selected
6. Menu Selection: Lists setup options and functions
During testing, the Mission® PT/INR meter will display icons showing the
status, options available, and prompts for testing. At the bottom of the
display are three function labels representing options which can be selected
by pressing one of the three keys directly below each of the display labels
(programmable key functions). These three programmable keys are used to
move through the meter menus for setting and selecting options for the
operation of the meter. Each key represents the function indicated by the
label at the bottom of the display, directly above the button.
All display functions are represented by English labels, icons, or numbers.
The “Icons” function is an alternative setting from the setup menu showing
all display items as icons, with minimal use of English labeling.
Throughout this User’s Manual, the label shown on the display will be used
to indicate the button to press to set or implement a function.
When the meter is turned on by pressing the power button (far-right button),
the first screen will show the available setup options. From this screen, all
meter settings can be changed, with their functions described below.
Pressing ◄Prev or Next► will move the selection box to the previous or
next function, indicating which function is selected. In the example above,
Code # is selected and the next function is Data Log. As ◄Prev or Next►
is pressed, the labels will shift to the left or right, revealing additional
functions. The selected function will be shown with a box around it.
1 2 3
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Pressing OK will show the submenu for the function selected.
The available functions are shown in order below.
After the last function is selected, the display will cycle through and return to
the first again. The purpose of each function is shown below.
Code #
Displays the Code Chip Number
Data Log
To review previous test results
Contrast
Adjusts the display contrast
Date
Sets the meter date
Time
Sets the meter time
Audio On/Off
Turns the meter sound on or off
/
Meter Info
Displays the meter serial number and software version
number
English
Displays meter messages in English or as Icons
INR/INR+PT
Allows Prothrombin Time to be shown in addition to INR
values
Password
Password protects patient data in the meter
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Section 4 Initial Setup
Before turning the meter on, insert the code chip (found inside the box of test
strips) into the code chip slot on the right side of the meter. This is shown
below. This will transfer the test strip testing parameters into the meter.
Note: Ensure the code number printed on the code chip is the same as
that printed on the test strip box and the same as the number
shown on the meter test screen when a test strip is inserted.
Code #
Press the power button (right button) to turn the meter on. The Setup
menu will be displayed after the power-on diagnostics test screen. The
Code # will be highlighted when the meter is turned on. Press OK to view
the current Code # from the code chip. The code chip number is also
displayed when a test strip is inserted, after the meter is turned on and
patient ID has been entered.
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If there is no code chip in the meter when a test strip is inserted or there is a
code chip error, the following screen will be shown.
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Section 5 Meter Setup and Options
Memory Review
Select Data Log and press OK to review previous PT/INR Meter test results.
The following screen will be shown.
The last test result will be displayed showing the test INR or INR+PT value,
date, time, its test number and corresponding patient ID. Pressing Down will
show the previous result, if any. Pressing Up will move to the oldest test in
the test result list.
To print the data log(s), connect the printer to the RS232 printer connection
port at the top of the meter and press PRT/EX. The next screen will show the
printing options of one log or ten logs. One means printing the current
displayed log, while Ten means printing 10 consecutive logs starting from
the current log. Press Exit to quit the print screen and to go back to the Data
Log screen. When finished reviewing the test results, press and hold down
the PRT/EX button until the display returns to the previous menu selection
screen.
Deleting Stored Readings
When reviewing stored readings in the section above, all readings can be
deleted by momentarily pressing both the Up and Down buttons at the same
time. This will display the Delete Log screen below, with Delete Log?
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flashing.
Press OK to delete all stored data in the memory or Exit to exit without
deleting the stored data and return to the previous data screen.
Once all data is deleted, the memory review function will show only dashes
for the stored data.
Setting the Display Contrast
Select Contrast as shown in the screen below to adjust the display contrast.
Press the Up or Down buttons to increase or decrease the display contrast.
Press OK to save the setting and exit to the previous menu selection screen.
Setting the Date
Select Date to change the date format. The first screen shows the date
format selections. Press Down to move the selection box to the desired
format, then press OK to save the chosen format.
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The next screen will show the current date, with the first selection flashing. In
the screen below, the month is flashing. If the date format selection is
MM-DD-YY, the first number highlighted will be the month. Press Up or
Down to increase or decrease the current setting until the correct month is
shown.
Press OK to move the highlight to the day. Press Up or Down to increase or
decrease the setting until the correct day is shown.
Press OK to move the highlight to the year. Press Up or Down to increase
or decrease the setting until the correct year is shown.
Press OK to accept the new date and exit to the previous menu selection
screen.
Setting the Time
Select Time to choose the time format. Press Next► to move the selection
box between the 12 hour and 24 hour format. You may press Exit at any
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