Table of Contents

Section 1 Introduction .................................................................... 1

Section 2 Getting Started ............................................................... 2
Section 3 Components ................................................................... 5
Meter ·············································································· 5
Test Strips········································································ 8
Test Devices ···································································· 8
Control Strips or Control Devices ········································ 13
Section 4 Initial Setup................................................................... 15
Turn on Meter ································································· 15
Coding the Meter ···························································· 16
Section 5 Meter Setup and Options ............................................. 17
Test Number Setup ·························································· 18
System Setup ································································· 19
Section 6 Testing .......................................................................... 23
Specimen Collection ························································ 23
Test Processing ······························································ 29
Section 7 Data/Communication.................................................... 34
Data Transmission··························································· 34
Deleting Data ································································· 35
Memory/Database ··························································· 36
Section 8 Optical System Check .................................................. 37
Optical Check ································································· 37
Section 9 Quality Control ............................................................. 39
Section 10 Maintenance ............................................................... 40
Cleaning········································································ 40
Replacing the Batteries ···················································· 42
Section 11 Precautions................................................................. 43
Section 12 Troubleshooting ......................................................... 44
Appendix 1 Meter Specifications ................................................. 45
Appendix 2 Index of Symbols ...................................................... 46
Appendix 3 Warranty .................................................................... 47
 Section 1 Introduction
The Mission® Plus Hb Hemoglobin Testing System is intended for the
quantitative determination of hemoglobin (Hb) and calculated hematocrit
(Hct) in capillary and venous human whole blood. 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 strip or device, ensuring quick
and accurate results.

The Mission® Plus Hb Hemoglobin Testing System provides results in less

than 15 seconds and requires only a single drop of whole blood. The meter
can store up to 1,000 results and records can be transferred to a computer
for further analysis using the USB port. The meter can be operated by 4
AAA (1.5V) batteries or an optional AC adapter.

To ensure accurate results:

 Read instructions and complete any necessary training before use.

 Use the code chip that accompanies each box of test strips or
devices.

 Use only Mission® Plus Hb Hemoglobin Test Strips or Mission® Plus

Hb Hemoglobin Test Devices with the Mission® Plus Hb Hemoglobin
Meter.

 For in vitro diagnostic use only.

 For professional use only.

 Test only whole blood specimens. EDTA or heparin anticoagulants

can be used.

 Keep out of reach of children.

Note: Throughout this user guide, meter parts or functions will

appear in bold. Items appearing on displays are identified
in bold italics.
1
 Section 2 Getting Started
Inspect the kit box, meter and accessories for any visible damage. For US
customers, call customer service toll free at 1-(800)-838-9502 if any visible
damage exists. For customers outside the US, contact your local
distributor. Remove the meter and other packaging contents from the kit
box. The starter kit consists of the following:
For use with test strips:

2
For use with test devices:

3
Hb Meter: Reads the test devices and displays the hemoglobin (Hb)
concentration and calculated hematocrit (Hct) value.
Test Strips or Test Devices: Part of the system and used with the meter
to measure Hb concentration and calculated Hct in blood.
Code Chip: Automatically calibrates the meter with the code number when
inserted into the meter.
Capillary Transfer Tubes or Droppers: Collects 10 µL of capillary blood
for fingertip blood testing and accurate results.
AAA Batteries： Provides power for the meter.
Carrying Case: Provides portability for testing.
User’s Manual: Provides detailed instructions on using the Hb
Hemoglobin Testing System.
Quick Reference Guide: Provides a brief overview of the Hb Hemoglobin
Testing System and testing procedures.
Test Strips or Test Devices Package Insert: Provides detailed
instructions on using the Hb Hemoglobin Test Strips or 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 using
the Lancing Device.
Sterile Lancets: Used with lancing device to draw blood specimens.
Sterile lancets are inserted into the lancing device with each blood draw and
discarded after use.
Control Strip or Control Device: Verifies the proper operation of the
meter by checking that the meter can detect a pre-calibrated value.
Control Strip or Control Device Package Insert: Provides detailed
instructions on using the Hb Hemoglobin Control Strips or Control Devices.
Warranty Card: Should be completed and returned to the distributor to
qualify for the 2-year meter warranty.

4
 Section 3 Components
The Mission® Plus Hb Hemoglobin Meter reads the test strips and displays
the hemoglobin (Hb) concentration and hematocrit (Hct) value. Use this
diagram to become familiar with all the parts of your meter.

Meter
For use with test strips:

For use with test devices:

5
 1 USB Port 6 Left Arrow ◄ Button
2 Liquid Crystal Display (LCD) 7 Strip/Device Channel
3 Code Chip 8 Strip/Device Holder
4 Right Arrow ► Button 9 Code Chip Slot
5 On/Off Button 10 Battery Cover

Meter Display
During testing, the Mission® Plus Hb Hemoglobin Meter will display icons
showing the status, options available and prompts for testing:

Sound Icon: Appears when the sound is turned on.

Battery: Appears when the battery should be replaced.
Test Number: Indicates assigned test number.
Test Result Area: Indicates test result or displays menu options.
Memory: Indicates a test result is being recalled from memory.
Code: Indicates the code number of the test strip or devices.
Measurement Units: Indicates the units for the test result.
Hct Value: Shows calculated Hct value.
Test Strip and Blood Drop Symbols: Indicates when to insert test
strip/device or apply specimen.

6
Meter Use and Precautions
 Do not get water or other liquids inside the meter.
 Keep the Strip/Device Channel clean.
 Keep the meter dry and avoid exposing it to extreme temperatures or
humidity.
 Do not drop the meter or get it wet. If meter is dropped or has gotten
wet, ensure the meter is working properly by running an Optical Check.
Refer to Optical System Check in Section 8 for details.
 Do not take the meter apart. Taking the meter apart will void the
warranty.
 Refer to Section 10 Maintenance for details on cleaning the meter.
 Keep the meter and all associated parts out of reach of children.

Note: Follow proper precautions and all local regulations when

disposing of the meter and used batteries.

All Hb systems preventive warnings with regard to EMC

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 Strips
The Mission® Plus Hb Hemoglobin Test Strips are thin plastic strips which
contain a chemical reagent system which works with the Mission® Plus Hb
Hemoglobin Meter to measure the hemoglobin (Hb) concentration in capillary
and venous whole blood.
Each test strip appears as shown:

Specimen Application Area - After strip is inserted into the Strip Channel,
apply 10 µL of blood to the center of the test strip. The Specimen
Application Area is visible from the front and the back of the test strip.
Insert Arrows - Located on the front of the test strip, the arrows show the
direction in which the test strip should be inserted.

Test Devices
The Mission® Plus Hb Hemoglobin Test Devices are plastic devices, in which a
reagent layer containing a chemical reagent system works with the Mission®
Plus Hb Hemoglobin Meter to measure the hemoglobin (Hb) concentration in
capillary and venous whole blood.
Each test device appears as shown:

8
Insert Arrows - Located on the front of the test device, the arrows indicate the
direction in which the test device should be inserted.
Specimen Application Area - After device is inserted into the Device Channel,
apply 10 µl of blood to the hole 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.

9
Specimen Application
For best results, fill the Specimen Application Area with approximately 10 µL
of blood specimen. Incorrect results may occur if the specimen is not
applied correctly, or if the Specimen Application Area is not filled.

Or

After applying the specimen, ensure 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 strip or device.

Or

10
 Note: Do not add more blood to the test strip or test device if the
specimen applied to the Specimen Application Area is too
little. Error E-5 or a low result may appear on the display.
Discard the used strip/device and retest.

Code Number
Each package of test strips or test devices is printed with a code number
, lot number , unopened expiration date and test quantity .
Whenever a new canister is opened, mark the date on the label. Calculate
the opened expiration date by adding three months. Record this opened
expiration date on the label.

Test Strips or Test Devices Precautions and Instructions

for Use
 Test Strips or Test Devices should be stored tightly capped in their
protective canister to keep them in good working condition.
 Do not store test strips or test devices outside their protective canister.
Test strips or test devices must be stored in the original canister with
the cap tightly closed.
 Do not transfer test strips or test devices to a new canister or any
other container.
 Replace the cap on the test strips or test devices canister immediately
after removing a test strip or test device.

11
  A new canister of test strips or test devices may be used for 3 months
after first being opened. The opened expiration date is 3 months
after the date the canister was first opened. Write the opened
expiration date on the canister label after opening. Discard the
canister 3 months after it is first opened. Usage after this period may
result in inaccurate readings.
 For in vitro diagnostic use. Test strips or test devices are to be used
only outside the body for testing purposes.
 Do not use test strips or test devices that are torn, bent, or damaged
in any way. Do not reuse test strips or test devices.
 Before performing a hemoglobin test, make sure that the code
number on the meter display matches the number shown on the test
strip canister and on the code chip ink-jet printed.

Refer to the test strips or test devices package insert for more details.

12
Control Strips or Control Devices
The Mission® Plus Hb Hemoglobin Control Strips or Control Devices are
plastic strips or devices containing a brown reference pad which works with the
Mission® Plus Hb Hemoglobin Meter to ensure the optical system is working
properly. After the control strip or device is inserted into the meter, the optical
system of meter detects the color intensity of the control strip or device. The
meter displays YES or no to show whether the meter is functioning properly.
Refer to Section 8 Optical Check for details.

The control strip/device appears as shown below:

Or

Precautions
 Store in the closed canister at room temperature within 2-30°C (36 -
86ºF) and avoid exposing it to direct sunlight, extreme temperature or
humidity.
 Control strips or control devices should be stored tightly capped in
their protective canister to keep them in good working condition.
 Do not freeze or refrigerate.
 Keep the control strips or control devices clean and do not bend. Do
not touch the test area of the strip or device.
 Remove the control strip or control device for immediate use. Put
13
 the control strip or control device back and close the canister tightly
immediately after use. Do not use contaminated, discolored, bent or
damaged control strips or control devices.
 Do not use after the expiration date.
 For in vitro diagnostic use only.
Storage and Handling
 Store control strips or control devices in a cool, dry place. Store
away from heat and direct sunlight.
 Transport and store in its closed canister within 2-30 ºC (36-86 ºF),
less than 85% humidity.
 Do not freeze or refrigerate.
 Replace the cap on the control strips or control devices canister
immediately after removing it from container.
 A new canister of control strips or control devices may be used for 1
year after first being opened. The opened expiration date is 1 year
after the date the canister was first opened. Write the opened
expiration date on the canister label after opening. Discard the
canister 1 year after it is first opened. Usage after this period may
result in inaccurate readings.

Note: The expiration date is printed in a Year-Month format.

For example, 2011-01 is January, 2011.

14
 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 located on the back of the meter.
To use the meter with the power adapter, connect the Mini USB port of the power
adaptor to the USB port located on the top of the meter with a USB cable, and
plug the adaptor into a 100-240V ac, 50-60 Hz primary power outlet.
The meter can also be powered from the USB port of a personal computer,
connected by a USB cable.

OR

The meter will turn on automatically after the batteries are inserted. The
meter will display the date and time setup screen. Refer to Section 5 Meter
Setup 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, and there are no missing icons or elements. After
startup, observe there are no permanently turned on segments or icons. After
the power-on diagnostic check, the Initial Screen will be displayed.
The meter will turn off automatically after 8 minutes of inactivity.

15
Coding the Meter
Each time a new box of test strips or test devices is used, the code chip
packaged with the new box of test strips or test devices must be inserted into
the meter. Take the code chip from the test strips or test devices box.
Compare the code number on the code chip with the code number printed
on the canister label. Results may be inaccurate if the two numbers are not
identical. For US customers, immediately call customer service toll free at
1-(800)-838-9502 if the code number on the code chip does not match the
number on the canister label with which it was packaged. For customers
outside the US, contact your local distributor immediately.
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 strips or test devices is needed. The code
number will appear on the Initial Screen after startup.

For US Customers, immediately call customer service toll free at

1-(800)-838-9502 if the code number on the code chip does not match the
number that is displayed on the screen. For customers outside the US,
contact your local distributor immediately.
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.

16
Section 5 Meter Setup and Options
With the meter turned off, press and hold for 4 seconds to enter Meter
Setup mode shown below.

Press ◄ or ► to display several setup submodes:

No. SEt Test number setup. The test number can be set from 1 to 999.
SEt System setup, including date, time, test number reset, units and
sound.
CHE Optical Check mode. Refer to Section 8.
PC Data Transfer mode. Refer to Section 7.
dEL Memory Delete mode. Refer to Section 7.
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 submode is displayed.

17
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 – 999.

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 999, the next test
number will be 1.

18
System Setup
From the SEt screen, press to enter System Setup.

Hour Setup

The first 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 Year Setup.

19
Year Setup

The year will appear at the top of the display. Press ◄ or ► until the
correct year is displayed.

Press to save and enter Month and Date Setup.

Month and Date Setup

The month and date will appear at the top of the display separated by a
single dash (-), with flashing month. Press ◄ or ► until the correct month
is displayed.

Press to save. The day will flash. Press ◄ or ► until the correct day
is displayed, then press to save and proceed to Time Setup.

20
Time Setup

The hour and minutes will appear at the top of the display separated by a
colon, with flashing hour.

Press ◄ or ► until the correct hour is displayed. Press to save and

proceed to Minutes.
Note: The meter will display AM or PM if the 12H time setting is
chosen.
Minutes will flash. Press ◄ or ► until the correct Minutes are displayed.
Press to save and proceed to Test Number Reset Setup.

Test Number Reset Setup

Press ◄ or ► to turn the test number reset ON or OFF. The test number
will reset to 1 for each new day of testing when the test number reset is
turned on. Press to save and proceed to Units Setup.

OR

21
Units Setup

Press ◄ or ► to select either g/dL, g/L or mmol/L.

OR OR

Press to save and proceed to Sound Setup.

Sound Setup

Press ◄ or ► to select sound either ON or OFF. The Sound Symbol will

appear on the display when the sound is turned on. Press to save and
return to the setup screen.

OR

Press ◄ or ► until Elt is displayed and press to exit setup. The

screen will briefly go blank and display the Initial Screen.

22
 Section 6 Testing
Before performing any test, the user should review the Mission® Plus Hb
Hemoglobin meter manual for detailed instructions. The following steps show
how to use each component to measure the hemoglobin concentration.

Specimen Collection
The Mission® Plus Hb Hemoglobin Meter requires a very small specimen
which may be obtained from the whole blood. Fresh or EDTA or
heparin-anticoagulated capillary or venous whole blood may be used.
Before testing, choose a clean, dry work surface. Review the procedure and
make sure all of the items needed to obtain a drop of blood are available.
Venous Blood Testing
For fresh whole blood venous specimens, collect the venous blood in a
closed container with EDTA or heparin anticoagulants. Mix the specimen
well, then collect approximately 10 μL into a plastic syringe or pipette.
Apply it to the center hole of the Specimen Application Area of the
strip/device. Do not touch the test strips or test devices with the pipette.
 Whole Blood must be tested within 8 hours of collection.
 Mix the specimens well before testing in order to ensure the cellular
components are evenly distributed.
 Allow the specimen to come to room temperature (15-30°C or 59-86ºF)
for approximately 15 minutes if the specimen has been refrigerated.
 Anticoagulants other than EDTA and heparin are not recommended
for use.
Note: Refer to NCCLS Documents H3-A6, Collection of Diagnostic
Blood Specimens by Venipuncture.
Fingertip Blood Testing
Wipe away the first drop of blood. Apply light pressure to obtain a second
drop of blood. Collect 10 μL of capillary blood using a Capillary Transfer
Tube or pipette.

23
 Note: Refer to NCCLS Documents H04-A6, Collection of Diagnostic
Blood Specimens by Skin Puncture.
For use with the Capillary Transfer Tube, hold the tube slightly downward
and touch the tip of the Capillary Transfer Tube to the blood drop. Capillary
action will automatically draw the sample to the fill line and stop.

Note： Make sure the blood covers the air vent of the tube or it will
be hard to squeeze blood out. Never squeeze the Capillary
Transfer Tube while sampling.
Align the tip of the Capillary Transfer Tube with the center hole of the
Specimen Application Area of the test strips or test devices to apply the
second drop of blood (approximately 10 μL).

Or

Note： Do not touch the test strips or test devices with the Capillary
Transfer Tube or pipette. The capillary blood should be
tested immediately after collected. Use of a Capillary
Transfer Tube or pipette is recommended for accurate
results.

24
For REF C112-3021/C112-3031:
Blood specimens can also be obtained by using a lancing device. Refer to
the instructions below for details.

For obtaining a drop of blood from the fingertip, adjust the penetration depth
on the lancing device to reduce discomfort.
Unscrew the lancing device cover from the body of the lancing device.
Insert a sterile lancet into the lancet holder and push it until the lancet comes
to a complete stop in the lancet holder.

Hold the lancet firmly in the lancet holder and twist the safety tab of the
lancet until it loosens, then pull the safety tab off the lancet. Save the
safety tab for lancet disposal.

25
Carefully screw the cover back onto the lancing device. Avoid contact with
the exposed needle. Make sure the cover is fully seated on the lancing
device.

Adjust the puncture depth by rotating the lancing device cover. There are a
total of 6 puncture depth settings. To reduce discomfort, use the lowest
setting that still produces an adequate drop of blood.
Use settings 1 and 2 for delicate skin, 3 and 4 for normal skin, and 5 and 6
for calloused or thick skin.

Note: Greater pressure of the lancing device against the finger will
also increase the puncture depth.

Pull the cocking barrel back to set the lancing device. A click may be heard.
The device is now loaded and ready for obtaining a drop of blood.

26
Prior to testing, make sure the patient‘s hand is warm and relaxed before
collecting the capillary blood specimen. Use warm water to increase blood
flow if necessary. Massage the hand from the wrist up to the fingertip a few
times to encourage blood flow.
Clean the testing site with an alcohol swab and then dry the testing site
thoroughly.

Hold the lancing device against the side of the finger to be lanced with the
cover resting on the finger. Push the release button to prick the fingertip.
A click should be heard as the lancing device activates. Gently massage
from the base of the finger to the tip of the finger to obtain the required blood
volume. Avoid smearing the drop of blood. For the greatest reduction in
pain, lance on the sides of the fingertips. Rotation of sites is recommended.
Repeated punctures in the same spot can make the fingers sore and
callused.

Note: Make sure the patient‘s hand is warm and relaxed before
collecting a capillary blood specimen. Use warm water to
increase blood flow if necessary.

27
Disposal of the Lancet

Unscrew the lancing device cover. Place the safety tab of the lancet on a
hard surface and carefully insert the lancet needle into the safety tab.

Press the release button to make sure that the lancet is in the extended
position. Slide the ejection button forward to eject the used lancet. Place
the lancing device cover back on the lancing device.

28
Test Processing
Ensure the meter is set up properly as described in previous sections. 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, and there are no missing icons or elements. The meter will
briefly show a blank display. Observe there are no segments or icons
permanently turned on.

After startup, the Initial Screen will be displayed. Ensure the code chip is
inserted, and compare the number showed in the display with the code
number printed on the canister label. Refer to Section 4 Coding the Meter.
The strip symbol will flash when the meter is ready for the device to be
inserted.

29
Testing

For use with a test strip, insert a test strip into the Strip/Device Channel in
the same direction as the arrows indicate on the strip. Ensure that the test
strip is inserted all the way to the end of the Strip/Device Channel, until the
white edge of the test strip above the black line is no longer visible.

For use with a test device, insert a test device into the Strip/Device Channel
in the same direction as the arrows indicate on the device. Ensure that the
test device is inserted all the way to the end of the Strip/Device Channel,
until the Insert Arrows are parallel with the two arrows on the Device Holder.

30
The blood drop symbol will flash when the meter is ready for the specimen
to be applied. Apply approximately 10 µL of blood to the center hole of the
Specimen Application Area of the test strip or test device.

Or

Note: For testing capillary blood, use the second drop of blood for
accurate results. Refer to Section 6 Fingertip Testing for
details.

31
 The meter will begin testing automatically with three dashes in a line
flashing on the display indicating the test is in progress.

Hb results will be displayed within 15 seconds, with Hct value displayed at

the bottom of the screen.

If the concentration of hemoglobin is less than 4.5 g/dL (45 g/L or 2.8
mmol/L), the meter will display Lo. The meter will display Hi if the
concentration is more than 25.6 g/dL (256 g/L or 15.9 mmol/L).

OR

32
Remove the used test strip or test device. The meter will return to the initial
screen ready for another test strip or test device to be inserted and a test
performed.
Note: Discard all blood specimens, used test strip or test device and
materials carefully. Treat all blood specimens as if they
were infectious materials. Follow proper precautions and
obey all local regulations when discarding blood specimens
and materials.

Perform daily cleaning when testing is completed for the day. Refer to
Section 10 Maintenance.
The meter will automatically turn off after 8 minutes of inactivity, or when
is pressed. If the meter is powered with an AC adaptor, turn off the meter
before removing it from the power outlet. Remove the batteries if the meter
will not be used for an extended period of time.

33
 Section 7 Data/Communication
Data Transmission
Plug the USB cable into the USB port located on the top of the meter and
connect the other end of the USB cable to a suitable PC.

Note: The PC must have suitable software installed to receive and

process the data being transmitted from the meter.

From the Setup screen (refer to Section 5 Meter Setup), press ◄ or ► until
PC is displayed. Press to enable the Data Communication mode,
MEM will be displayed.

Press to transmit data to an external certified PC.

After data transmission is complete, the meter will return to the Setup Menu.

Note: Up to 999 test records are automatically stored in memory.

After 999 test records are stored, the oldest test record will be
replaced by a new record. For example, if 999 records are
stored in memory, the next test result (1,000) will replace the
first result stored in memory.

34
Deleting Data
To delete all data from the meter database, enter the Setup Menu (refer to
Section 5 Meter Setup). Press ◄ or ► until dEL is displayed.

Press to enable data deletion, MEM will be displayed.

Press and hold until the meter returns to the Setup Menu.

35
Memory/Database
From the Initial Screen (refer to Section 5 Meter Setup), press ◄ or ► to
show the first record.

Press ◄ or ► to view each record in date/time sequence. Press and hold

to return to the Initial Screen.

If no data is stored the meter will display one dash (-) and MEM.

36
 Section 8 Optical System Check
Optical Check
Press ◄ or ► from the Setup Screen to select the Optical Check mode as
shown.

Note:
 The control strip or control device is intended for checking the
optical system. Refer to Section 9 Quality Control Test for using
control solutions.
 Allow the control strips or control devices and the meter to reach
room temperature (15-30ºC or 59-86ºF) prior to testing.
 The optical check should be performed under normal lab lighting
conditions. Do not perform under sunlight or extreme lighting
conditions.
Press to enter this mode. The meter will flash the strip symbol as
shown below.

37
Insert a control strip or control device into the Strip/Device Channel in the
same direction as the arrows indicate on the strip or device. Ensure that the
control strip or control device is inserted all the way.
Press to start the optical check. If the meter displays YES, the meter is
normal. If the meter displays no, the meter is not functioning properly.

OR

If the meter displays no, check the control strip for contamination or if it is
bent or damaged. If there are any visible signs of damage or contamination,
discard the control strip or control device and retest using a new strip or
device.
Note: For US customers, call customer service toll free at
1-(800)-838-9502 if the meter displays no again. For
customers outside the US, contact your local distributor to
double check if any Problem with system.

Press to return to the Setup Screen.

38
 Section 9 Quality Control
Each lab should use its own standards and procedures for performance.
Test known specimens/controls at each of the following events in
accordance with local, state, and/or federal regulations or accreditation
requirements.
 Each new day of testing
 A new canister of test strips or test devices is opened
 A new operator uses the analyzer
 Test results seem inaccurate
 After performing maintenance or service on the analyzer

If QC tests do not provide expected results, perform the following checks:

 Ensure the test strips or test devices used are not past their expiration
date.
 Ensure test strips or test devices are fresh from a new canister.
 Ensure the controls are not past their expiration date.
 Repeat the test to ensure no errors were made during the test.

For US customers, call customer service toll free at 1-(800)-838-9502 for

additional information. For customers outside the US, contact your local
distributor.

39
 Section 10 Maintenance
Proper maintenance is recommended for best results.

Cleaning
For best results, the meter should be cleaned after each day of testing.

Meter Surface

A cotton cloth can be used to clean the surface of the meter. Use a damp
cotton cloth if necessary.
A dry, soft cloth may be used to clean the LCD and the sensor area. It is
recommended that the meter be stored in the carrying case after each use.
Take care to avoid getting liquids, residue, or control solutions in the meter
through the Strip Channel, Code Chip Slot or USB Port.

Test Strip Holder

Remove the Test Strip Holder by pressing in on middle of the Test Strip
Holder and sliding it out from the meter. Wipe it with a damp cloth or a mild
detergent and dry it with a dry, soft cloth. Slide the Test Strip Holder back
into the meter by laying it flat on the meter. Firmly press down on two side
of the Test Strip Holder with your thumb and push it in until it clicks into
place.

Or

Note: Do not use organic solvents, such as gasoline or paint thinner.

This will cause damage to the meter.

40
Meter Sensor Area

Remove the Test Strip Holder as described in the previous section. Wipe
down the Meter Sensor Area with a cotton swab. Do not scratch the
transparent window covering the sensor.

Note: Do not use bleach or alcohol to clean the Meter Sensor Area.
This will cause damage to the meter.

41
Replacing the Batteries
When the battery icon is flashing, the battery
is running low and should be replaced as soon as
possible. An E-4 error message will appear if the
battery is too low to perform any more tests. The
meter will not function until the battery is replaced.

Make sure the meter is off before removing the battery. Turn the meter
over to locate the battery cover. Press the battery cover tab on the top and
lift the cover to open it. Remove and discard the old batteries. Insert four
AAA batteries on top of the plastic tape. Make sure the two outside
batteries are aligned with the plus (+) side down, towards the bottom of the
meter, with the middle battery aligned with the plus (+) side facing up,
towards the top of the meter.

Close the battery cover and make sure that it snaps shut. Recheck and
reset the clock setting as necessary after battery replacement to ensure time
is set correctly. Refer to Section 4 Initial Setup.
Note: Do not discard batteries along with household waste. Follow
local regulations for disposal.

42
 Section 11 Precautions
Observe the precautions listed below to ensure accurate results and proper
operation of the analyzer.

 The protection provided by the equipment may be impaired if used in

a manner not defined in this instruction manual.
 Wear gloves to avoid contact with potentially hazardous biological
specimens during testing.
 Avoid storing or operating the meter in direct sunlight, excessive
temperature, or high humidity. Refer to Appendix 1 Meter
Specifications for operating condition requirements.
 Keep the unit clean. Wipe it frequently with a soft, clean and dry
cloth. Use fresh water when needed.
 Do not clean the unit with substances such as gasoline, paint thinner
or other organic solvents to avoid any damage to the meter.
 Do not clean the LCD or sensor area with water. Lightly wipe with a
soft, clean, dry rag.
 The Strip Channel must be kept clean. Lightly wipe with a soft, clean,
dry rag each day. Use water as needed. Refer to Section 10
Maintenance.
 Follow all local regulations when discarding the unit or its accessories.
 Do not use the unit or the devices outside of the operating
temperature ranges listed below.
Analyzer: 10-40 ºC (50-104 ºF) ; ≤90％ RH
Strips: 15-30 ºC (59-86 ºF) ; ≤85％ RH

43
 Section 12 Troubleshooting
Display Causes Solution
Ensure the sensor area is clean and that
The sensor area is damaged, there are no objects covering the sensor
dirty, or blocked at turn-on, such area. Refer to Section 10 Cleaning.
as a used test strip/device left in Restart the meter. Contact your local
the meter. distributor if the sensor area window is
broken.
Test strip/device was removed Repeat the test and ensure the test
during the test. strip/device remains in place.
Specimen was applied to the Repeat the test and apply specimen after
test strip/device too soon. blood drop symbol appears.
Batteries are discharged but
Test results will still be accurate, but replace
have enough power to run 20
the batteries as soon as possible.
more tests.
Batteries have discharged and
meter will not allow more tests Replace the batteries, or connect the meter
until discharged batteries are to the AC Adapter, then repeat the test.
replaced.
Repeat test and apply enough specimen.
Insufficient specimen.
Use around 10 μL of whole blood.
Ensure the test strips/devices are within the
Expired test strips/device.
expiration date printed on the canister label.
Insert proper code chip. Confirm the
Code chip was removed during
code chip matches the test strips/device
testing.
code and repeat the test.
If the specimen was taken from a
The test result is lower than 4.5
specimen container, ensure the specimen
g/dL (45 g/L or 2.8mmol/L).
is mixed well and repeat test.
Insufficient specimen less than Repeat test and apply enough specimen.
1μL Use around 10 μL of whole blood.
The test result is higher than If the specimen was taken from a
25.6 g/dL (256 g/L or 15.9 specimen container, ensure the specimen
mmol/L). is mixed well and repeat test.
Insert the code chip that accompanied the
box of test strips/devices.
No code chip in the meter; If the code chip is damaged, use a new
Code chip is damaged or code chip with the correct code number.
inserted incorrectly. If the code chip is inserted incorrectly,
remove the code chip and insert it into the
code chip slot.
For US customers, call customer service toll free at 1-(800)-838-9502 for details. For
customers outside the US, contact your local distributor.

44
 Appendix 1 Meter Specifications
Feature Specifications

Methodology Reflectance Photometer

Test Time <15 seconds

Measurement Range 4.5-25.6 g/dL, 45-256 g/L, 2.8-15.9 mmol/L

Specimen Whole blood

Specimen Volume 10 μL

4 AAA batteries (1.5V)

Power Source
AC Adapter (Mini USB, 5V dc, 50 mA)

Battery Life 360 hours or 2,700 tests

Units of Measure g/dL, g/L, mmol/L

Memory 1,000 records

Automatic Shut Off 8 minutes after last use

Meter Size 137 mm × 79 mm × 26 mm (5.4” × 3.11” ×1.02”)

Display Size 50 mm × 50 mm (1.97” ×1.97”)

Weight 145g (without batteries)

Meter Storage Conditions 0 - 50 ºC (32 -122 ºF); ≤90％ RH

Operating Conditions 10 - 40 ºC (50 -104 ºF); ≤90％ RH

Meter Connectors USB cable for Data Transfer or Power (optional)

45
Appendix 2 Index of Symbols
Consult instructions for For In vitro
use diagnostic use only

REF Catalog # SN Serial Number

Authorized
Manufacturer
Representative

Lot Number Use by

Store between
Tests per Kit
2-30°C

Sterilized using
Code Number
irradiation

Do not discard along

USB Port
with household waste

Fragile, handle with care This Side Up

Keep away from sunlight

Keep Dry
and heat

Do not reuse

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 Appendix 3 Warranty
Please complete the warranty card included in the packaging. Mail it to your local
distributor to register your purchase within one year of purchase.
For your records, write the purchase date of your starter kit here:

Note: This warranty applies only to the meter in the original purchase. It does not
apply to the other materials included with the meter.
ACON Laboratories, Inc. warrants to the original purchaser that this meter will be free
from defects in materials and workmanship for a period of two years (24 months). The
two years starts from the later of the date of original purchase or installation (except as
noted below). During the stated two years period, ACON shall replace the meter under
warranty with a reconditioned meter or, at its option, repair at no charge a meter that is
found to be defective. ACON shall not be responsible for shipping charges incurred in
the repair of a meter.

This Warranty is subject to the following exceptions and limitations:

This warranty is limited to repair or replacement due to defects in parts or workmanship.
Parts required which were not defective shall be replaced at additional cost. ACON
shall not be required to make any repairs or replace any parts that are necessitated by
abuse, accidents, alteration, misuse, neglect, failure to operate the meter in accordance
with the user’s manual, or maintenance by anyone other than ACON. Furthermore,
ACON assumes no liability from malfunction or damage to meters caused by the use of
strips other than strips manufactured by ACON. ACON reserves the right to make
changes in the design of this meter without obligation to incorporate such changes into
previously manufactured meters.

Disclaimer of Warranties
This warranty is expressly made in lieu of any and all other warranties express or
implied (either in fact or by operation of law) including the warranties of merchantability
and fitness for use, which are expressly excluded, and is the only warranty given by
ACON.
Limitations of Liability
In no event shall ACON be liable for indirect, special or consequential damages, even if
ACON has been advised of the possibility of such damages.
For warranty service, please contact your local distributor.

47