Acon Mission Ultra User manual

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Mission®Ultra Hemoglobin Testing System
Hemoglobin is the main component of red blood cells whose main function is
to transport oxygen. The determination of hemoglobin concentration in whole
blood is useful in the clinical diagnosis of diseases such as anemia and
polycythemia.
Welcome and thank you for choosing ACON’s Mission®Ultra
Hemoglobin Testing System.
Intended Use
The Mission®Ultra Hemoglobin Testing System is designed for the
quantitative measurement of Hemoglobin level in fresh whole blood. Since
Hematocrit level is generally proportion to Hemoglobin concentration but
varies with individuals, Hematocrit is also tested and auxiliary for Hemoglobin
test. Venous blood should be collected with a designated anticoagulant.
Fingertip capillary blood should be collected with a lancet and can be tested
directly. It is intended for in vitro diagnostic use and suitable for polycythemia
and anemia management. The system is designed both for self-testing and
professional use and can be used for the intended purpose for adults and
children (≥2 years), but can’t be used for any tests for newborns.
To ensure accurate results
Read instructions in the User’s Manual and conduct any necessary
training before use.
Use the code chip that accompanies each box of test strips.
Use only Mission®Ultra Hemoglobin Test Strips with the Mission®Ultra
Hemoglobin Meter.
Test with fresh whole blood specimens. Do not use serum or plasma
specimen.
When testing with venous blood, collect the specimen with the
recommended anticoagulant listed in the strips package insert.
Verify the test results using clinical laboratory methods before making
any adjustments to your medication, diet or activity routines.
Keep out of reach of children.
Important Safety Instructions
Users should adhere to Standard Precautions when handling or using
this device.
All parts of the Hemoglobin Testing System should be considered
potentially infectious and are capable of transmitting blood-borne
pathogens between patients and healthcare professionals. For more

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information, refer to “Guideline for Isolation Precautions: Preventing
Trans Mission of Infectious Agents in Healthcare Settings 2007”.
http://www.cdc.gov/hicpac/2007ip/2007isolationprecautions.html .
Use the equipment only for the purpose described in the instructions
for use.
Do not use accessories which are not supplied or recommended by the
manufacturer.
Do not use the equipment if it is not working properly or if it has
suffered any damage.
Do not let the equipment or its flexible cord come into contact with
surfaces which are too hot to touch.
Do not use the equipment outdoors.
If the equipment is used in a manner not specified by the manufacturer,
the warranty provided for this equipment will be void.
Do not drop or put anything into any opening in the equipment, or into
any hose or coupling.
Keep in mind the instructions mentioned.
Note: Throughout this user’s manual, meter parts or functions will appear
in bold. Items appearing on displays are identified in bold italics.

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Table of Contents
Getting Started ............................................................................................ 1
Component Descriptions.......................................................................... 2
Mission®Ultra Hemoglobin Meter ............................................................ 3
Meter Display ........................................................................................... 4
Mission®Ultra Hemoglobin Test Strips ..................................................... 6
Mission®Ultra Hemoglobin Control Solution ............................................ 8
Setting up the Meter before Testing .........................................................11
Step 1 - Adjusting Meter Settings ............................................................11
Step 2 - Coding the Meter ...................................................................... 15
Performing a Quality Control Test ........................................................... 17
Performing a Hemoglobin Test ................................................................ 20
Step 1 – Collecting Blood Specimen ...................................................... 20
Step 2 - Testing for Hemoglobin ............................................................. 25
"HI" Messages........................................................................................ 29
Precautions and Limitations ................................................................... 30
Using the Memory ..................................................................................... 31
Viewing Stored Records ......................................................................... 31
Clearing the Memory.............................................................................. 32
Transferring Records.............................................................................. 32
Maintenance .............................................................................................. 34
Replacing Batteries ................................................................................ 34
Cleaning................................................................................................. 35
Suggested Target Goals ........................................................................... 36
Comparing Meter and Laboratory Results.............................................. 37
Troubleshooting Guide............................................................................. 38
Specification.............................................................................................. 40
Warranty..................................................................................................... 41
Index of Symbols ...................................................................................... 42

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Getting Started
Inspect the kit box, meter, and accessories for any visible damage. Remove
the meter and other packaging contents from the kit box. The following items
are needed to perform a test:

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Component Descriptions
Hemoglobin Meter: Conduct the hemoglobin test with whole blood and
display the test results on screen.
Carrying Case: Provides portability for Hemoglobin testing wherever you go.
User's Manual: Provides detailed instructions on how to use your
Hemoglobin Testing System.
Quick Reference Guide: A short set of instructions to get you started testing
with your new Hemoglobin Testing System.
Warranty Card: Should be completed and returned to the distributor to
qualify for the 2-year meter warranty.
Hemoglobin Test Strips: Chemical reagent system strips used with the
meter to measure the Hemoglobin concentration in blood.
Code Chip: Automatically calibrates the meter when inserted into the meter.
Lancing Device: Use with sterile lancets to prick the fingertip for blood
specimen collection. The packaged lancing device has multiple depth
settings which allow users to adjust the depth of the puncture and minimize
discomfort. It can also eject the used lancets.
Sterile Lancets: Use with the lancing device to draw a blood specimen. New
sterile lancets should be inserted into the lancing device for each test and
discarded after use.
Optional Components:
Mission®Ultra Hemoglobin Control Solution: Three levels of known
hemoglobin concentrations: Level 0 Low, Level 1 Middle and Level 2 High
are control solutions that can be purchased separately from the starter kit.
They are intended for use as a quality control check for the Mission®Ultra
Hemoglobin Testing System. Only perform quality control checks when
necessary. Hemoglobin controls are not included in the starter kit. Contact
your local distributor.

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Mission®Ultra Hemoglobin Meter
The Mission®Ultra Hemoglobin Meter conducts the hemoglobin test with
whole blood and displays the test results on screen. Use the diagram below
to become familiar with all parts of your meter.
Battery Cover: Remove battery cover to install two CR2032 coin cell
batteries.
Code Chip: Automatically calibrates the meter when inserted into the meter.
Code Chip Slot: Holds the code chip.
Data Port: Sends information to a computer via an optional data transfer
cable to view, analyze and print stored data in the meter. The data transfer
cable is available as an optional accessory.
Liquid Crystal Display (LCD): Displays test results and guides the testing
process.

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<M> Button: Recalls previous test results from the meter memory.
<S> Button: Selects meter settings.
Strip Port: Test strips are inserted into this area to perform a test.
Strip Ejector: Slide the ejector upward to discard the test strip.
Note: All meter parts and all objects coming in contact with the blood
specimen are deemed as infectious matters. Follow proper precautions and
obey the local regulations when discarding these infectious matters.
Meter Display
During testing, the Mission®Ultra Hemoglobin Meter’s LCD screen will
display icons showing the status, options available, and prompts for testing:
Test number: Indicates the number of test.
Audio symbol: Indicates audio is turned on.
Control Solution Symbol: Indicates a control test is being performed or a
control result.
Finger symbol: Indicates the specimen in the test is a finger blood. If the
finger symbol is not displayed, it indicates the specimen in the test is a
venous blood.
Result Area: Displays the Code Number, Blood test result or Control test
result, Error No.
Blood Drop/Strip Symbol: Indicates the strip is inserted into the meter
correctly and it is ready to add specimen to the tip of the strip to start the test.
Memory: Indicates a test result being recalled from memory.
Month and Date Hour Minutes
A
udio/Control/
Finger Symbol
Blood/Strip
Symbol
HCT Result
Battery Symbol
Unit
Memor
y
Result
A
rea
Code
Te s t
Number

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Measurement Units: Indicates the units for the test result. The measurement
units can be changed by the user.
Battery Symbol: Appears when the batteries need to be replaced.
Code: Indicates the digits displayed in the result area are the code number of
the test strips.
HCT Result: Indicates the hematocrit test result.
Meter Use and Precautions
Do not get water or other liquids inside the meter.
Do not drop the meter. If you drop the meter or get it wet, check the
meter by running a quality control test. Refer to “Performing a Quality
Control Test” for instructions.
Do not take the meter apart. Taking the meter apart will void the
warranty.
Keep the Strip Port area clean.
Keep the meter dry and avoid exposure to extreme temperatures or
humidity, such as in a car.
Refer to” Maintenance” for details on how to clean the meter.
Keep the meter and all associated parts out of the reach of children.
The meter is pre-set to display blood hemoglobin concentration in
either millimoles per liter (mmol/L) or grams per deciliter (g/dL) or
grams per liter (g/L) depending on which unit of measure is standard
in your country.
Note: Follow proper precautions and all local regulations when disposing of
the meter and used batteries.
EMC Warnings
1. This device is tested for immunity to electrostatic discharge as specified
in IEC 61000-4-2. However, use of this instrument in a dry environment,
especially if synthetic materials are present (synthetic clothing, carpets,
etc.), may cause damaging static discharges resulting in erroneous
results.
2. This instrument complies with the emission and immunity requirements
described in EN61326-1 and EN61326-2-6. Do not use this instrument in
close proximity to sources of strong electromagnetic radiation, as this
may interfere with proper operation of the meter.
3. For professional use, the electromagnetic environment should be
evaluated prior to operation of this device.

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Mission®Ultra Hemoglobin Test Strips
The Mission®Ultra Hemoglobin Test Strips are thin strips with a chemical
reagent which works with the Mission®Ultra Hemoglobin Meter to measure
the hemoglobin concentration in fingertip capillary whole blood and venous
blood. Each test strip appears as shown below.
Code Number
Each package of test strips has a printed code number (CODE), lot number
(LOT), unopened expiration date ( ).
Test Strips Storage and Handling
Please review the following storage and handling instructions:
Store test strips in a cool, dry place at 2-30°C temperature range. Store
test strips away from heat or direct sunlight.
Do not freeze or refrigerate.
Do not store or use test strips in a high humidity location.
Do not store the meter, test strips or control solution near bleach or
cleaners that contain bleach.
Replace the cap on the test strip canister immediately after removal of a
test strip.
The test strip should be used immediately after removal from canister.

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Do not use your test strips past the unopened expiration date printed on
the label. Using test strips past the unopened expiration date may
produce incorrect test results.
After inserting the test strip in the strip port, the meter will automatically
turn off in 4 minutes of inactivity.
Note: The expiration date is printed in Year-Month format. 2018-01 means
January 2018.
Special Instructions for Test Strips in the Canister
Do not store test strips outside their protective canister. Test strips must
be stored in the original canister with the cap tightly closed to ensure
proper working conditions.
Do not transfer test strips to a new canister or any other container.
Replace the cap on the test strip canister immediately after removal of a
test strip.
A new canister of test strips can be used for 3 months after initial
opening. Write the opened expiration date on the canister label after
opening. Discard the canister in 3 months after your initial opening,
because usage after this period may result in inaccurate readings.
Test Strips Precautions
For in vitro diagnostic use. Test strips are to be only used outside the
body for testing purposes.
For self-testing and professional use.
Do not use test strips that are torn, bent, or damaged in any way.
Do not reuse test strips.
Use mild disinfectants such as alcohol solutions to clean the skin before
collected blood. Do not use oxidative disinfectants such as iodine
solutions. The remaining oxidative substances on the skin may cause
incorrect results.
Before running a hemoglobin test, make sure the code number on the
meter display matches the number shown on the test strip canister.
Keep the test strip canister away from children and animals.
For self-testers, consult your physician or healthcare professional
before making any changes in your treatment plan based on your blood
hemoglobin test results.
See the test strip insert for more details.

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Mission®Ultra Hemoglobin Control Solution
This control solution is used to confirm that your Mission®Ultra Hemoglobin
Testing System is working properly. The control solution also checks that you
are performing the test correctly. It is important to run a quality control test
regularly to make sure you are getting correct results.
You should run a quality control test:
Before your first use of the meter, familiarize yourself with its operation.
When you suspect that the meter or test strip is not working properly.
When you suspect that your test results are inaccurate, or if they are
inconsistent with how you feel.
When you suspect your meter is damaged.
Refer to “Performing a Quality Control Test” for instructions on how to run a
quality control test.
Storage and Handling
Please review the following storage and handling instructions.
Store the control solution at temperature 2-30°C. Avoid freezing.
If the control solution is cold such as stored in a refrigerator, do not use
until it has been warmed to the same temperature as the meter and the
strips.
Use before the unopened expiration date shown on the vial.
Note: The expiration date is printed in Year-Month format. 2018-01 means
January 2018.
Precautions
For in vitro diagnostic use. The control solution is only for testing
outside the body. Do not swallow or inject.
Shake gently without making bubbles before use.
Control tests are specified to be accurate only when tested between
10-40°C (50-104°F).
The control ranges shown on the control solution bottle are not
recommended ranges for your blood Hemoglobin level. Your personal
blood Hemoglobin target ranges should be determined by your
healthcare professional.
Use only the same brand of control solution that was provided with
your kit.
See the control solution insert for more details.

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Installing the Batteries
When you first receive the meter, batteries may not be preinstalled in the
meter. Two CR2032 coin cell batteries (3V) are required. The batteries can
be found in your carrying case. Install the batteries according to the following
steps:
1. Turn over the meter to locate the battery cover. Press in the direction of
the arrow on the battery cover and lift the cover to open it.
2. Insert two CR2032 coin cell batteries into the battery case, and note
the direction of battery.
3. Close the battery cover and make sure that it snaps shut.
Note: Batteries should be taken out when equipment is not used for an
extended period.
Turn on Meter
The meter will display the date and time setup screen. Refer to “Setting up
the Meter before Testing” for details. After the date and time have been set,
the meter will automatically turn off.
Open the test strip vial and remove one strip from the vial. Close the vial
immediately to protect the remaining strips from moisture damage. Insert a
test strip into the strip port with the contact bars end first and facing up. Insert
the strip in as far as it will go without extra force. This will turn on the meter
and display all the display segments. If the audio option is on, the meter will
beep to signal that the meter is turned on.
Note: Insertion of a new test strip at any time, except during the data
transfer mode (Refer to “Using the Memory”) will cause the meter to

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automatically enter the test mode.
If a strip is inserted into the meter but the meter doesn’t turn on, following the
steps below:
Check if the strip is facing up, same as the meter. If not, remove the
strip and reinsert the strip into the port with the correct side facing up.
Check if the strip is inserted into the port completely. If not, insert the
strip into the port completely.
Check if the strip is damaged. If yes, discard the strip.
If the strip is not damaged and is correctly inserted into the port but the
meter still doesn’t turn on, remove the strip and replace with another
strip.
If the meter still doesn’t turn on, remove the battery cover, check if two
batteries are in the meter. If not, place two batteries in the meter. If yes,
replace with two new batteries.
If you follow all of the steps mentioned above and the meter still doesn’t turn
on, contact your distributor for help.
Insert strip to turn on the meter. The screen will briefly display all of the LCD
symbols. Observe the LCD at this time to ensure all segments and display
elements are turned on, and there are no missing icons or elements. After
startup, observe whether there are any permanently turned on segments or
icons. After the power-on diagnostic check, the initial screen will be displayed
and the meter will automatically turn off after 4 minutes of inactivity.

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Setting up the Meter before Testing
Before using your meter for the first time, you will need to adjust the settings
that are listed in detail below.
Step 1 - Adjusting Meter Settings
1. The meter will automatically enter the setup mode when turned on for
the first time by battery installation. Otherwise, press the <S> Button for
2 seconds to enter the meter setup mode.
2. Clock: Set the clock to either 12 or 24 hour mode. Press the <M>
Button to switch between the two settings. Press the <S> Button to
save the setting.
Note: The clock needs to be reset after every battery replacement.
or
3. Date format: Set the date format to either US or Euro mode. Press the
<M> Button to switch between the two settings. Press the <S> Button
to save the setting.
or
4. Month, Day and Year (US mode): The Month will appear at the top of
the display. Press the <M> Button until the correct Month is displayed
and press the <S> Button to save the setting and proceed to the Day.
Press the <M> Button until the correct Day is displayed, then press the
<S> Button to save the setting and proceed to the Year.

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Press the <M> Button until the correct Year is displayed, then press the
<S> Button to save the setting.
Day, month and Year (Euro mode): The Day will appear at the top of the
display. Press the <M> Button until the correct Day is displayed and
press the <S> Button to save the setting and proceed to the Month.
Press the <M> Button until the correct Month is displayed, then press
the <S> Button to save the setting and proceed to the Year.
Press the <M> Button until the correct Year is displayed, then press the
<S> Button to save the setting.
5. Time: Once the day is set, the hour will appear at the top of the display.
Press the <M> Button until the correct hour is displayed. Press the <S>
Button to save the selection and proceed to set the minutes.
Press the <M> Button to set the minutes. Press the <S> Button to
save the setting and proceed to Audio.

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6. HCT: HCT result is turned on as the initial default. The meter will display
the HCT result when it is turned on. Press the <M> Button to switch
between turning the beep function “On” or “Off”. Press the <S> Button
to save the setting.
7. Unit Set: The meter is pre-set to display blood hemoglobin
concentration in either millimoles per liter (mmol/L) or grams per
deciliter (g/dL) or grams per liter (g/L) depending on which unit is
suitable for you. If you don’t know which unit is suitable, contact your
distributor for help. The initial default unit is g/dL. Press the <M> Button
to switch between g/dL or g/L or mmol/L. Press the <S> Button to
save the setting.
8. Blood Specimen: The meter allows the user to select between finger
blood or venous blood. The initial default blood specimen is finger blood
specimen. Press the <M> Button to switch between displaying the
Finger symbol (finger blood) or off (venous blood). Press the <S>
Button to save the setting.

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Note: The added blood specimen must be the same as the selected
blood type. If venous blood is selected, the meter will allow the user to
select between EDTA K2 and K3. The initial default is K2. Press the
<M> Button to switch between displaying P2 (EDTA K2) or P3 (EDTA
K3). Press the <S> Button to save the setting.
9. Audio: Audio is turned on as the initial default. The meter will give one
short beep when it is turned on, turned off, ready for the addition of
specimen, after specimen detection, and when the result is ready. The
meter will sound three short beeps to sound a warning when an error
has occurred. Press the <M> Button to switch between turning the
beeping function “On” or “Off”. Press the <S> Button to save the
setting.

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Step 2 - Coding the Meter
Every time a new box of test strips is opened, the code chip used with the
meter must be replaced with the new code chip from the test strip box.
1. Take the code chip out of the test strip box to compare the code
number on the code chip with the code number printed on the test
strip canister label. Results may be inaccurate if the two numbers are
not identical. If the code number on the code chip does not match the
number on the test strip canister with which it was packaged, please
contact your local distributor immediately. You will need a new
package of test strips to perform a test.
2. With the meter turned off, insert the new code chip into the code chip
slot of the meter. It should easily snap into place. The code chip
should remain in the meter. Do not take it out until you change to a new
box of test strips.
3. Turn the meter on by inserting a test strip. The code number will
appear on the initial screen after startup. If the code number on the
test strip canister label does not match the number displayed on the
screen, please contact your local distributor immediately.