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.