Acon Mission User manual

ⅰ
Mission®Cholesterol Monitoring System
Important Safety Instructions
If the meter is powered by AC adapter, unplug the equipment
immediately after use.
Misuse of electrical equipment can cause electrocution, burns,
fire and other hazards.
Do not place the equipment in liquid, nor put it where it could fall
into liquid. If the equipment becomes wet, unplug it before
touching it.
If the meter is powered by AC adapter, do not leave the equipment
unattended while it is plugged in.
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 where aerosol sprays are being used or
where oxygen is being administered.
Do not use the equipment in direct sun.
Keep these instructions.

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Table of Contents
Section 1 Introduction ...........................................................................1
Section 2 Getting Started ......................................................................2
Section 3 Components ..........................................................................4
Meter........................................................................................................ 4
Test Devices............................................................................................. 7
Control Devices........................................................................................ 9
Control Solution...................................................................................... 10
Section 4 Initial Setup..........................................................................13
Turn on Meter......................................................................................... 13
Coding the Meter.................................................................................... 13
Section 5 Meter Setup and Options....................................................15
Test Number Setup ................................................................................ 15
System Setup......................................................................................... 16
Section 6 Testing .................................................................................22
Specimen Collection............................................................................... 22
Test Processing...................................................................................... 28
Section 7 Coronary Heart Disease (CHD) Risk Evaluation...............31
Section 8 Data/Communication ..........................................................38
Data Transmission ................................................................................. 38
Deleting Data ......................................................................................... 38
Memory/Database.................................................................................. 39
Section 9 Optical System Check ........................................................41
Section 10 Quality Control ..................................................................43
Control Solution Testing ......................................................................... 43
Interpreting Results ................................................................................ 45
Section 11 Maintenance ......................................................................46
General Cleaning ................................................................................... 46
Disinfection Process............................................................................... 47
Replacing the Batteries .......................................................................... 48
Section 12 Precautions........................................................................49
Section 13 Troubleshooting................................................................50
Appendix 1 Meter Specifications........................................................52
Appendix 2 Index of Symbols .............................................................53
Appendix 3 Warranty ...........................................................................54

1
Section 1 Introduction
The Mission®Cholesterol Monitoring System is intended for the quantitative
determination of Total Cholesterol (CHOL), High-Density Lipoprotein
Cholesterol (HDL), Triglycerides (TRIG), calculated Low-Density Lipoprotein
Cholesterol (LDL), and the calculated ratio of CHOL/HDL in capillary and
venous human whole blood, plasma, and serum. Professionals can also
evaluate a patient’s 10-year risk of Coronary Heart Disease with this system.
The easy-to-operate system consists of a portable meter that analyzes the
intensity and color of light reflected from the reagent area of a test device,
ensuring quick and accurate results.
The Mission®Cholesterol Monitoring System provides results in less than 2
minutes. The meter can store up to 200 results and records can be
transferred to a computer for further analysis using the USB port. The meter
can be operated with 4 AAA (1.5V) batteries or an optional AC adapter.
To ensure accurate results:
Read instructions carefully and complete any necessary training before
use.
Use the code chip that is included in each box of test devices.
Only use the Mission®Cholesterol Test Devices with the Mission®
Cholesterol Meter.
For in vitro diagnostic use only. Your blood cholesterol monitoring
system is only to be used outside the body for testing purposes.
For self-testing and professional use.
For professional use: Fresh capillary blood, heparinized or EDTA
venous whole blood, serum and heparinized plasma can be tested. For
self-testing use: Only test fresh capillary blood from the fingertip.
For self-testing, consult your physician or healthcare professional
before making any adjustments to your medication, diet or activity
routines.
Keep out of reach of children.
Note: Throughout this User’s Manual, meter parts or functions will
appear in bold. Items appearing on displays are identified in
bold italics.

2
Section 2 Getting Started
Before testing, read the instructions carefully and learn about all the
components of the Mission®Cholesterol Monitoring System. Depending on
the package type, some of the components may need to be purchased
separately. Please check the list of contents on the outer box for details on
which components are included with your purchase. The following items are
needed to perform a test:
Cholesterol Meter
AAA Batteries
Lancing Device
Capillary Transfer Tube/Dropper
Safety Lancet
Sterile Lancets
Test Device Control Device
Front Back Front Back
Code Chip
Carrying Case
Control Solution

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Cholesterol Meter: Reads the test devices and displays the concentrations
of CHOL, HDL, TRIG, and calculated LDL and CHOL/HDL values.
Test Devices: Part of the system, these are inserted into the meter to
measure the concentrations of CHOL, HDL, and TRIG, from which LDL and
the CHOL/HDL ratio are calculated.
Code Chip: Automatically calibrates the meter with the code number when
inserted into the meter.
Capillary Transfer Tubes/Droppers: Collects capillary blood from fingertip
blood testing for accurate results (10µL for an individual test and 35µL for a
3-in-1 test).
Capillary Transfer Tubes Insert: Provides detailed instructions on using
the Capillary Transfer Tubes.
AAA Batteries: Provides power for the meter.
Carrying Case: Provides portability for testing.
User’s Manual: Provides detailed instructions on using the Cholesterol
Monitoring System.
Quick Reference Guide: Provides a brief overview of the Cholesterol
Monitoring System and its testing procedures.
Test Devices Package Insert: Provides detailed instructions on using the
Cholesterol Test Devices.
Lancing Device: Used with sterile lancets to prick the fingertip for blood
specimen collection. The packaged lancing device has multiple depth
settings, allowing users to adjust the depth of the puncture and minimize
discomfort. It can also eject the used lancets.
Lancing Device Package Insert: Provides detailed instructions on how to
use the lancing device.
Sterile Lancets: Used with the lancing device to draw blood specimens for
individual tests. Sterile lancets are inserted into the lancing device for each
blood draw and discarded after use.
Safety Lancets: Used to draw blood specimens for the 3-in-1 test and
individual tests. Discard after use.
Control Device: Verifies the proper operation of the meter by checking that
the meter can detect a pre-calibrated value.
Control Device Package Insert: Provides detailed instructions on how to
use the Control Devices.
Control Solution: Verifies that the test is being performed correctly and
validates that the test device and meter are working together properly.
Warranty Card: Card included in the package, which should be completed
and returned to the distributor to qualify for the 2-year meter warranty.

4
Section 3 Components
The Mission®Cholesterol Meter reads the test devices and displays the
concentrations of CHOL, HDL, TRIG, the calculated value of LDL and the
ratio of CHOL/HDL. Use the below diagram to become familiar with all the
parts of the meter.
Meter
1 USB Port 7 Device Channel
2 Liquid Crystal Display (LCD) 8 Test Device Holder
3 Code Chip 9 Position Arrows
4 Right Arrow Button ►10 Code Chip Slot
5 On/Off Button 11 Battery Cover
6 Left Arrow Button ◄

5
Meter Display
During testing, the Mission®Cholesterol Meter will display icons showing the
status, options available, and prompts for testing:
1 Battery Icon 8 Memory Indicator
2 Sound Icon 9 Code
3 Date 10 Measurement Units
4 Test Number 11 Te s t I t e m
5 Blood Drop Symbol 12 Systolic Blood Pressure
6 Test Result Area 13 Yes/No Option
7 Test Device Symbol 14 Options for Gender, Smoker
or Non-smoker, and MI
Battery Icon: Appears when the battery should be replaced.
Sound Icon: Appears when the sound is turned on.
Date: Shows the current date or date tested.
Test Number: Indicates the specimen type and assigned test number.
Test Result Area: Displays the test result or menu options.
Memory Indicator (MEM): Appears when a test result is being recalled
from memory.
Code: Shows the code number of the test devices.
Measurement Units: Displays the measurement units of the test result.
Test Device and Blood Drop Symbols: Indicate when to insert test device
or apply specimen.
Test Item: Shows which item is being tested.
Systolic Blood Pressure: Needed for CHD risk analysis. Calculated CHD is
for professional use only.

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Yes/No Option: Displays answer to yes/no questions during CHD risk
analysis. Calculated CHD is for professional use only.
Options for Gender, Smoker or Non-smoker, and MI: Displays answers to
questions regarding gender, smoking status and history of heart attack (MI).
Calculated CHD is for professional use only.
Meter Use and Precautions
Do not get water or other liquids on or inside the meter.
Keep the Device Channel clean.
Keep the meter dry and avoid exposing it to extreme temperatures and
humidity.
Do not drop the meter or get it wet. If the meter is dropped in water or
becomes wet, ensure the meter is working properly by running an
Optical Check. Refer to Optical System Check for details.
Do not take the meter apart. Taking the meter apart will void the
warranty.
Refer to Maintenance for details on cleaning the meter.
Keep the meter and all associated parts out of the reach of children.
Note: Follow proper precautions and all local regulations when
disposing of the meter and used batteries.
All EMC Preventative Warnings for the Cholesterol
Monitoring System
1. This instrument 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 that
may cause erroneous results.
2. This instrument complies with the emission and immunity
requirements described in EN 61326-1 and EN 61326-2-6. Do not
use this instrument in close proximity to sources of strong
electromagnetic radiation, as these may interfere with proper
operation of the meter.
3. For professional use, the electromagnetic environment should be
evaluated prior to operation of this device.

7
Test Devices
The Mission®Cholesterol Test Devices are plastic devices that work with the
Mission®Cholesterol Meter to measure the lipid concentration in whole blood,
plasma and serum.
Test device appears as shown below:
The following test devices are currently available for use with the Mission®
Cholesterol Meter:
3-in-1 Lipid Panel
Total cholesterol (CHOL) individual test device
High-Density Lipoprotein (HDL) individual test device
Triglyceride (TRIG) individual test device
The 3-in-1 Lipid Panel can detect CHOL, HDL and TRIG with one device
simultaneously. Calculated LDL and the ratio of CHOL/HDL can also be
calculated by the meter at the same time.
Insert Arrow: Located on the front of the test device, the arrows indicate the
direction in which the test device should be inserted into the meter.
Specimen Application Area: After the test device is inserted into the Device
Channel, apply the correct specimen volume (10µL for individual test devices
or 35µL for 3-in-1 test devices) to the region in the center of the test device.
Handle: Located on the end of the test device, the handle is used to insert
and remove the test device from the meter.
Test Area: Located on the back of the test device. The meter will detect and
read this area to give results of lipid levels.
Position Arrows:Located in the middle of the specimen application area (of
the test device). When a test device is inserted, the two arrows should be
parallel with the two arrows on the meter holder to make sure the test device is
inserted correctly.

8
Specimen Application
For best results, fill the Specimen Application Area with the correct specimen
volume (10µL for individual test devices or 35µL for 3-in-1 test devices).
Incorrect results may occur if the specimen is not applied correctly or if the
Specimen Application Area is not filled with the correct amount, as shown in
the pictures below.
After applying the specimen, ensure that the Specimen Application Area is
completely covered. The Specimen Application Area should remain covered
throughout the entire test. If the Specimen Application Area is not covered
or if there is too much specimen covering the Specimen Application Area,
repeat the test with a new test device.
Note: If the specimen applied to the Specimen Application Area is not
enough, do not add more specimen to the test device. Instead,
retest with a new device. If the E-5 Error or another error
appears on the display, please discard the used device and
retest with a new device.
Code Number
Printed on each package of test devices is a code number , lot number
, unopened expiration date, and test quantity .

9
Test Device Precautions and Instructions for Use
Test Devices should be stored in their foil pouch to keep them in
working condition.
Do not store test devices outside of their package. Test devices must
be stored in the original package.
Do not transfer test devices to a new package or any other container.
For in vitro diagnostic use. Test devices are to be used only outside
the body for testing purposes.
Use the test device immediately after removing it from the foil pouch.
Do not use test devices that are torn, bent, or damaged in anyway.
Do not reuse test devices.
Before performing a test, make sure that the code number on the
meter display matches the number shown on the test device foil pouch
and on the ink-jet printing on the code chip.
Refer to the test device package insert for more details.
Control Devices
The Mission®Cholesterol CTRL Control Devices are gray and black devices,
which work with the Mission®Cholesterol Meter to ensure the optical system is
working properly. After the control device is inserted into the meter, the
meter’s optical system detects the color intensity of the reference pad in the
control device. The meter displays YES or no to indicate whether the meter
is functioning properly. Refer to Optical System Check for details.
The control device appears as shown below:
Precautions
Store in the closed canister at room temperature or in the refrigerator
within 2-30°C (36 – 86ºF). Avoid exposure to direct sunlight, extreme

10
temperatures, and humidity.
Control devices should be stored in their tightly capped canister to
keep them in working condition.
Do not freeze or refrigerate.
Keep the control devices clean. Do not touch the test area of the
device.
Remove the control device from its canister for immediate use. Put
the control device back and close the canister tightly immediately after
use. Do not use contaminated, discolored, or damaged control
devices.
Do not use after the expiration date.
For in vitro diagnostic use only.
Storage and Handling
Store test devices in a cool, dry place. Store away from heat and
direct sunlight.
Transport and store in its closed canister at a temperature between
2-30ºC (36-86ºF) with less than 90% humidity.
Do not freeze or refrigerate.
Replace the cap on the devices canister immediately after removing a
device. Expired devices may produce incorrect test results.
Note: The expiration date is printed in a Year-Month format.
For example, 2011-01 is January, 2011.
Control Solution
The Mission®Cholesterol Control Solution contains stabilizers, preservatives
and added chemicals. High-density lipoprotein (HDL) and triglyceride (TRIG)
are included in the same control solution. Total Cholesterol (CHOL) is an
individual control solution. To confirm that the test device and meter are
working together properly and that the test is being performed correctly, the
control solution is applied to the specimen well of a Mission®Cholesterol test
device that has been inserted in the meter. Refer to the Quality Control
section in the User’s Manual for more information.

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Note: The Mission®Cholesterol Control Solution is intended for
validating cholesterol testing while using the Mission®
Cholesterol Monitoring System. Both levels of control
solutions must be tested and fall within the assigned values
printed on the bottles.
Refer to the control solution package insert before using the controls. The
control solution bottle is labeled with the acceptable range that is specific for
that lot of control solution. The system is working properly if the control value
displayed by the meter is within the acceptable range printed on the bottle
label. If the value does not fall within the range, refer to the Control Solution
Package Insert for further instructions.
Precautions
Set the specimen type to blood (bL) before testing with the control solution.
Make sure the control solution and all the test materials reach operating
temperature of 20 - 40°C (68 - 104°F) prior to testing. The control solutions
and test materials are only accurate within this temperature range.
Use the control solution before the expiration date shown on the bottle.
Discard the control solution if it appears cloudy.
Use the Mission®Cholesterol Control Solution with the Mission®
Cholesterol meter and test devices.
Make sure the control solution bottle is tightly closed before use.
The used device should be discarded according to local regulations after
testing.
Check the code chip before performing a test. Make sure to use the code
chip that is included with the box of test devices.
HDL/TRIG
Level 2
HDL/TRIG
Level 1
CHOL
Level 1
CHOL
Level 2

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Storage and Handling
• Store the control solution either refrigerated or at room temperature
2 - 30°C (36 - 86°F).
• Do not freeze.
• If the control solution has been refrigerated, allow it to warm up to a
temperature of 20 – 40°C (68 - 104ºF) before use.
• Each control solution will expire 4 months after the bottle is opened for the
first time. Record this expiration date on the bottle label.
Note: The expiration date is printed in a Year/Month format.
For example, 2016-01 is January, 2016.

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Section 4 Initial Setup
Before testing, ensure the following procedures are followed.
Turn on Meter
The meter can be operated using the certified AC Adapter or 4 AAA batteries
(1.5V).
To use the meter with batteries, insert 4 AAA batteries (1.5V) into the battery
compartment on the back of the meter.
To use the meter with a power adapter, use a USB cable to connect the Mini USB
port of the power adapter to the USB port on the top of the meter. Then plug the
adapter into a 100-240V ac, 50-60 Hz primary power outlet.
The meter can also be powered from a personal computer with a USB cable.
The meter will automatically turn on after the batteries are inserted. The
meter will display the date and time setup screen. Refer to Meter Setup and
Options for details. After the date and time have been set, the meter will
automatically turn off.
Press to turn the meter on. The screen will briefly display all of the LCD
symbols. Observe the LCD at startup to ensure all segments and display
elements are turned on. There should not be missing icons or elements. After
startup, ensure that there are no permanently turned on segments or icons.
After the power-on diagnostic check, the Initial Screen will be displayed.
The meter will automatically turn off after 5 minutes of inactivity.
Coding the Meter
Each time a new box of test devices is used, the new code chip included in
the box must be inserted into the meter. Compare the code number on the
OR

14
code chip from the box with the code number printed on the test device foil
pouch. Results may be inaccurate if the two numbers are not identical.
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 a new box of test devices is needed. The code number will
appear on the Initial Screen after startup.
If the code chip is not properly inserted into the code chip slot or if it is
missing, the meter will display three dashes as shown below.

15
Section 5 Meter Setup and Options
With the meter turned off, press and hold for 4 seconds to enter the
Meter Setup mode, shown below.
Press ◄or ►to display several setup sub-modes:
No. SEt Test number setup. The test number can be set from 1 to 99.
CHE Optical Check mode. Refer to Optical System Check.
SEt System setup, including date, time, test number reset, units,
sound, specimen type and CHD.
PC Data Transfer mode. Refer to Data/Communication.
dEL Memory Delete mode. Refer to Data/Communication.
Elt Exit setup modes and save changes when is pressed.
The meter will automatically return to the Initial Screen.
Press to enter the mode when the desired sub-mode is displayed.
Test Number Setup
From the No. SEt screen, press to enter Test Number Setup.
The test number can be set to any number from 1 to 99.

16
Press ◄or ►until the correct test number is displayed. To quickly cycle to
the desired test number, press and hold ◄or ►.
Press to save and return to the Meter Setup screen.
Note: Once the meter reaches test number 99, the next test number
will be 1.
System Setup
From the SEt screen, press to enter the System Setup.
Unit Setup
The first option sets the units to either mg/dL or mmol/L. Press ◄or ►to
switch between the two settings.
OR

17
Hour Setup
The second option sets the clock to either 12 or 24 hour mode. Press ◄or
►to switch between the two settings.
Press to save and advance to Date Setup.
Date Setup
The third option sets the date to Y-M-D, M-D-Y or D-M-Y mode. Press ◄or
►to switch between the three settings.
Press to save and advance to the Year Setup.
Note: The date in the display will be shown in the form of M-D or D-M
according to the mode you select. However, the year will not
be shown on the display due to limited space. The year will
only be shown during data transfer, such as printing or
exporting data to computer.
Year Setup
The year will appear at the top of the display with Yindicating year setup.
Press ◄or ►until the correct year is displayed.
OR