e-LinkCare ACCUGENCE PM900 User manual

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Multi-Monitoring System
Thank you for choosing ACCUGENCE® Multi-Monitoring System (Model: PM900).
You now have a very simple and accurate way to test your Blood Glucose, β-Ketone
and Uric Acid from fresh whole blood samples in just a few simple steps anytime,
anywhere.
Attention: ACCUGENCE® Blood Glucose Test Strips with ACCUGENCE® Multi-
Monitoring System are intended for in-vitro diagnostic self-testing by people with
diabetes and healthcare professionals in clinical settings. ACCUGENCE® Blood
Ketone Test Strips and ACCUGENCE® Uric Acid Test Strips with ACCUGENCE® Multi-
Monitoring System are intended for in-vitro diagnostic for self-testing and
professional use.
To ensure accurate results from your ACCUGENCE® Multi-Monitoring System,
please follow these guidelines carefully:
• Read instructions before use.
• ACCUGENCE® Multi-Monitoring system is intended for in- vitro diagnostic use
only. It is intended to be used with ACCUGENCE® Blood Glucose Test Strips,
ACCUGENCE® Blood β-Ketone Test Strips, and ACCUGENCE® Uric Acid Test
Strips to quantitatively measure glucose, β-hydroxybutyrate (β-ketone), and
uric acid from whole blood sample.
Note: There are two types of ACCUGENCE® Blood Glucose Test Strips available,
ACCUGENCE® Blood Glucose Test Strips using Glucose Oxidase (GLU GOD) and
ACCUGENCE® Blood Glucose Test Strips using Glucose Dehydrogenase FAD-
dependent (GLU GDH).
• ACCUGENCE® Multi-Monitoring Meter with ACCUGENCE® Blood Glucose Test
Strips are intended for use by people with diabetes mellitus at home and by
healthcare professionals in clinical settings as an aid to monitor the
effectiveness of diabetes control. It is not intended for use in the diagnosis of
or screening for diabetes mellitus.
Note: When ACCUGENCE® Blood Glucose Test Strips (Glucose Oxidase) are used,
only fresh capillary whole blood is allowable to be used for testing. When
ACCUGENCE® Blood Glucose Test Strips (Glucose Dehydrogenase FAD-
dependent) are used, fresh capillary whole blood or venous whole blood is
allowable to be used for testing, but venous whole blood testing is limited for
professional use only.
• ACCUGENCE® Multi-Monitoring Meter with ACCUGENCE® Blood Ketone Test
Strips are intended for use for the quantitative measurement of β-
hydroxybutyrate (β-ketone) in fresh capillary whole blood or venous whole

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blood. It should NOT be used to diagnose DKA, and venous whole blood testing
is for professional use only.
• ACCUGENCE® Multi-Monitoring Meter with ACCUGENCE® Uric Acid Test Strips
are intended for use for the quantitative measurement of uric acid in fresh
capillary whole blood or venous whole blood but venous whole blood testing is
for professional use only.
• The device should not be used for patients who are dehydrated, in shock,
critically ill or in a hyperosmolar state.
• Use the assorted calibration chip that accompanies each type of test strip when
tests are applied. Used with single-use, auto-disabling lancing device.
• Test only whole blood samples with the assorted ACCUGENCE® brand Blood
Glucose Test Strips, Blood β-Ketone Test Strips and Uric Acid Test Strips along
with ACCUGENCE® Multi-Monitoring Meter.
• For self-testers, consult your physician or healthcare professional before
making any adjustments to your medication, diet or activity routines.
• Keep out of reach of children.
By following the instructions outlined in this User’s Manual, you will be able to use
your ACCUGENCE® Multi-Monitoring System to monitor your blood glucose, β-
ketone and uric acid and better manage your healthcare.

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Table of Contents
Table of Contents ............................................................................................... iii
Getting Started .................................................................................................... 1
Components Descriptions ...................................................................... 2
ACCUGENCE® Multi-Monitoring Meter ................................................... 3
Meter Display ......................................................................................... 5
ACCUGENCE® GLU GOD/GLU GDH/KET/UA Test Strips ........................... 8
ACCUGENCE® GLU/KET/UA Control Solution ........................................ 11
Installing Batteries ............................................................................................ 13
Meter Setup Before Testing ............................................................................... 14
Coding the Meter .............................................................................................. 21
Performing a Quality Control Test ...................................................................... 23
Test ing Your B loo d ............................................................................................. 28
Step 1 – Getting a Drop of Blood .......................................................... 28
Step 2 – Test ing Your Blood .................................................................. 32
Testing Yo ur Blo od Glu cos e ................................................................... 32
Testing Yo ur Blo od β-Ketone ................................................................. 40
Testing Yo ur Uric Acid ........................................................................... 42
Recall the Meter Memory .................................................................................. 45
Viewing Stored Records ........................................................................ 45
Clearing the Memory ............................................................................ 49
Transferring Records ............................................................................. 50
Maintenance ..................................................................................................... 52
Replacing the Batteries ......................................................................... 52
Caring for Your ACCUGENCE® Multi-Monitoring System ....................... 53
Suggested Testing Times and Target Goals ......................................................... 54
Comparing Meter and Laboratory Results .......................................................... 56
Troubleshooting Guide ...................................................................................... 57
Specifications .................................................................................................... 59
Index of Symbols ............................................................................................... 61
Warranty Card ................................................................................................... 62

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Getting Started
Before testing, read the instructions carefully and learn about all the components
of your ACCUGENCE® Multi-Monitoring System. Please note that some of the
components may need to be purchased separately from your local distributor.
Please check the list of contents on the outer box for details on which components
are included with your purchase.
Lancing Device Sterile Lancet
Carrying Case
Test Strips
Control Solution
Meter
Calibration Chip

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Components Descriptions
1. ACCUGENCE® Multi-Monitoring Meter: Reads the test strips for blood glucose,
β-ketone, uric acid and displays each concentration.
2. Test Strips: Strips with a chemical reagent system used with the meter to
measure glucose, β-ketone or uric acid concentration in blood.
3. Calibration Chip: Automatically calibrates the meter with the type of test strips
a patient wants to perform once inserted into the meter.
4. Lancing Device: Used with sterile lancets to prick the fingertip for blood sample
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.
5. Sterile Lancet: Single-use, sterile lancet is used with the lancing device to
obtain blood samples. Discard it after a single use.
6. Control Solution: Verifies the proper operation of the ACCUGENCE® Multi-
Monitoring System by checking the test strips and meter against a pre-
calibrated control solution, which are available in the ACCUGENCE® Multi-
Monitoring System Control Solution package which is sold separately.
Note: For Glucose and β-Ketone control solution, there are three levels with
Level 1, Level 2 and Level 3. For Uric Acid, there are two levels with Level 1 and
Level 2.
7. Carrying Case: Provides portability for testing wherever you go.
8. User’s Manual: Provides detailed instructions on using the ACCUGENCE® Multi-
Monitoring System.

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ACCUGENCE® Multi-Monitoring Meter
The meter reads the test strips of blood glucose, β-ketone and uric acid and displays
each concentration. Please read diagrams below to become familiar with all the
parts of your meter.
Strip Ejector
Start/Power
Strip/Calibration
Chip Port
Liquid Crystal
Display (LCD)
Down Button
Up Button
Battery
Cover
SN Label
Data Transfer Port

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Strip Port: Test strips are inserted into this area to perform a test / Coding the meter
by inserting the calibration Chip.
Strip Ejector: Slide the ejector forward to discard the used test strip.
Liquid Crystal Display (LCD): Shows your test results, and helps you through the
testing process.
Start/Power: Enter setting model and confirm the setting, when the meter is in PC
and Memory mode, press Start/Power button, the meter will turn off.
Up Button: Selects meter settings and performs other menu selection functions.
Down Button: Recalls previous test results from the meter memory and performs
other menu selection functions.
Battery Cover: Remove the battery cover to install two CR2032 coin cell batteries.
Data Transfer 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 for order as an optional add-on.
Attention: Dispose of blood samples and materials carefully. Treat all blood samples
as if they are infectious materials. Follow proper precautions and obey all local
regulations when disposing of blood samples and materials.

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Meter Display
Number
Symbol
Indicator
Means
1
Date
Indicates the testing date in month/day format.
2
MEM
Average
Average glucose in 7, 14, 30, 60 and 90-days.
3
Time
Indicates the time of 24H format or 12H format.
4
Low Power
Icon
Warns you when you should replace the battery.
5
Strip Icon
Blood Drop / Strip Icon will appear before applying
the sample and during the time of meter
reminding. These two symbols appear at the same
time.
6
Blood Drop
Icon
Blood Drop / Strip Icon will appear before applying
the sample and during the time of meter
reminding. These two symbols appear at the same
time.
7
Code Icon
Indicates the test strip calibration code number.

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8
GLU GOD /
GLU GDH
or KET or
UA
Strip
type or
Test
Paramet
er
Indicates different strip type or test parameter.
GLU GOD / GLU GDH means the meter is currently
performing the glucose test with strip of either
GOD or GDH enzyme. KET means blood β-ketone
test, UA stands for uric acid test.
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Test Result
Area
Indicates the test result and calibration code
number.
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Measure-
ment Unit
Measurement units differ from different test
parameter, mg/dL and mmol/L are for Glucose,
mmol/L are for β-Ketone, mg/dL and μmol/L are
for Uric Acid.
Note
：
When glucose testing is performed, only
one unit of measure will be displayed on your
meter and it cannot be adjusted.
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Before
Meal Icon
Appears when before-meal test results are
displayed.
After Meal
Icon
Appears when after-meal test results are displayed.
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QC Icon
Indicates a test result when running quality
control.
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Invalid
Value Icon
Appears if mark the value is invalid, and also will
be displayed together with control solution value.
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Glucose
Target
Range
Up Arrow Symbol appears when the blood glucose
concentration is above the “Hyperglycemia” (high
blood sugar level) target level that you have set.
Down Arrow Symbol: Appears when the blood glucose
concentration is below the “Hypoglycemia” (low
blood sugar) target level that you have set.
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Blood
Ketone
Reminder
Symbol
Appears when the blood glucose concentration is
above 16.7 mmol/L (300 mg/dL). This simply suggests
that a β-Ketone test is recommended. Consult your
healthcare professional about testing for β-Ketones.
Note: This symbol does not mean that the system
has detected β-Ketones. It recommends that a β-
Ketone test should be taken.
16
MEM
Shows a test result stored in memory.
17
Test
Remind
Icon
This icon appears to remind you to test your blood
glucose.
18
Sound Icon
This icon appears when the sound is turned off.

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Meter Use and Precautions
• Wait for the Blood Drop / Strip Symbol to appear before applying the sample.
• The meter is pre-set to display depending on which unit of measure is standard
in your country. Blood glucose concentration in either millimole per liter
(mmol/L) or milligrams per deciliter (mg/dL), uric acid concentration in either
milligrams per deciliter (mg/dL) or micromole per liter (μmol/L). This unit of
measure cannot be adjusted.
• The meter will shut off automatically 2 minutes after inactivity.
• Do not get water or other liquids inside the meter.
• Keep the strip port area clean.
• Keep your meter dry and avoid exposing it to extreme temperatures or
humidity. Do not leave it in your car.
• Do not drop the meter or get it wet. If you do drop the meter or get it wet,
check the meter by running a quality control test.
• Do not take the meter apart. Taking the meter apart will void the warranty.
• 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 battery.
All Systems Preventive Warnings with Regard to EMC:
• 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.
• 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 these may
interfere with proper operation of the meter.
• For professional use, the electromagnetic environment should be evaluated
prior to operation of this device.

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ACCUGENCE® GLU GOD/GLU GDH/KET/UA Test Strips
The ACCUGENCE® GLU GOD/GLU GDH/KET/UA Test Strips are thin strips with a
chemical reagent which works with the ACCUGENCE® Multi-Monitoring Meter to
measure the glucose, β-ketone or uric acid concentration in whole blood
respectively. After the strip is inserted into the meter, blood is applied to the sample
tip of the test strip. The blood is then automatically absorbed into the reaction cell
where the reaction takes place. A transient electrical current is formed during the
reaction and the blood glucose, β-Ketone, uric acid concentration is calculated based
on the electrical current detected by the meter. The result is shown on the meter
display. The meter is calibrated to display plasma equivalent results.
Example of a blood glucose test strip using glucose oxidase (GOD):
IMPORTANT: Apply the sample only to the sample tip of the test strip. Do not apply
blood or control solution to the top of the test strip as this may result in an inaccurate
reading.
Contact Bars
Insert this end of the test strip
into the meter until it stops.
Sampling Tip
Apply blood or control
solution area.
Check Window
Check to confirm that a sufficient
sample has been applied.
Direction Arrow
Insert strips following
the arrow direction.

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Hold the blood drop to the sample tip of the test strip until the check window is
completely full and until the meter begins to count down. If you applied blood but
do not see the starting of the count down, you may reapply a second drop of blood
within 3 seconds. If the check window does not fill and the meter starts to
countdown, then do not add more blood to the test strip. If you do, then you may
get an E-5 message or an inaccurate test result. In this case, if the meter begins to
countdown and the check window does not fill, discard the strip and begin the test
again with a new test strip.
Code Number
Each package of test strips is printed with a code number (CODE), lot number (LOT),
unopened expiration date ( ) and control range. Please make sure that the
calibration code number printed on the package of each test strip matches with the
code inside of the package.
Storage and Handling
Please review the following storage and handling instructions:
• Store test strips in a cool, dry place, 2 - 35°C (36 - 95°F) for glucose strips and
ketone strips, 2 - 30°C (36 - 86°F) for uric acid strips. Store them away from heat
and direct sunlight.
• Do not freeze or refrigerate.
• Do not store or use test strips in a humid place such as a bathroom.
• Do not store the meter, the test strips or control solution near bleach or
cleaners that contain bleach.
• The test strip should be used immediately after removing it from the container.
• Repeated insertion and removal of a test strip into the meter strip port may
result in reading errors.
• 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.
Correct
Incorrect
Correct
Incorrect

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Note: The expiration date is printed in Year-Month format. 2019-01 means
January, 2019.
Special Instructions for Test strip in the Vial
• Test strips must be stored in the original vial with the cap tightly closed. This
keeps them in good working condition.
• Do not transfer test strips to a new vial or any other container.
• Close tightly the cap on the test strip vial immediately after removing a test
strip.
• A new vial of test strips may be used for 6 months after being first opened.
Write the opened expiration date on the vial label after opening. Discard the
vial 6 months after you first open it. Usage after this period may result in
inaccurate readings.
Note: Uric Acid Test Strips may only be used for 3 months after being first
opened.
Special Instructions for Test Strip in the Foil Pouch
• Tear the pouch carefully from the tear gap. Avoid damaging or bending the test
strip.
• Use the test strip immediately after removing it from the pouch.
Test Strip Precautions
• For in vitro diagnostic use. Test strips are to be used only outside the body for
testing purposes.
• Do not use test strips that are torn, bent, or damaged in any way. Do not reuse
test strips.
• Keep the test strips vial or the foil pouch away from children and animals.
• Consult your physician or healthcare professional before making any changes
in your treatment plan based on your test results.
See the Test Strip Insert for more details.

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ACCUGENCE® GLU/KET/UA Control Solution
The ACCUGENCE® GLU/KET/UA Control Solution contains a known concentration of
glucose, β-ketone and uric acid respectively. It is used to confirm that your
ACCUGENCE® Multi-Monitoring Meter and test strips are working together properly
and 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 you first use your meter, to familiarize yourself with its operation.
• Before using a new box of test strips.
• When you suspect that the meter or test strips are 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.
• After cleaning your meter.
• At least once a week.
Refer to the Section Quality Control Test for instructions on running a quality
control test.
Storage and Handling
Please review the following storage and handling instructions:
• Store the glucose and β-ketone control solution at 2 - 35°C (36 - 95°F), and store
uric acid control solution at 2 - 30°C (36 - 86°F).
• Do not refrigerate or freeze.
• If the control solution is cold, do not use until it has warmed to room
temperature.
• Use before the unopened expiration date that is shown on the bottle.
Note: The expiration date is printed in Year-Month format. 2019-01 means
January, 2019.
• Each bottle of control solution can be used for 6 months after you first open it.
Record the opened and the resulting expiration dates on the bottle label.
Note: Uric acid control solution may only be used for 3 months after being first
opened.
Control Solution Precautions
• For in vitro diagnostic use. The control solution is for testing only outside the
body. Do not swallow or inject.
• Shake well before using.
• Glucose and β-Ketone control solution tests are designed to be accurate only
when tested between 5 - 45°C (41 - 113°F), while uric acid control solution tests
are safe to perform between 10 - 40°C (50 - 104°F).

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• The control ranges shown on the test strip vial (or on the foil pouch) are not
recommended ranges for your blood glucose/ β-ketone /uric acid level. Your
personal blood glucose/ β-ketone / uric acid target ranges should be
determined by your healthcare professional.
• Do not touch the test strip with the tip of the control solution bottle directly.
• 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 Batteries
The batteries may not be preinstalled in the meter. Two CR2032 3.0V coin cell
batteries are required. Please find the batteries in your carrying case and install
them according to the following steps:
1. Turn over the meter and slide the battery cover in the direction of the arrow
to open it.
2. Place two fresh CR 2032 3.0V coin cell batteries. Make sure they are aligned
with the plus (+) side facing up in the battery carrier.
3. Close the battery cover and make sure that it snaps shut.

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Meter Setup Before Testing
Before using your meter for the first time, you will need to adjust the settings that
are listed in detail below:
1. Meter Setup Mode: Press the Power button for 2 seconds. The meter will
automatically enter the setup mode for the first time by any method. Please
double check the battery level. Replacing with new batteries may also enable
this mode.
2. Clock: Set the clock to 12 or 24-hour mode. Press the Up or Down button to
switch between the two settings, then press the Power button to save your
choice and then start setting the year, month and date.
Note: The clock needs to be reset after replacing the batteries.
3. Date: The year will appear at the top of the display. Press the Up or Down
button to select the proper year. Once you have selected the correct year,
press the Power button to save your choice and start setting the month. Press
the Up or Down button to select the proper month. Then press the Power
button to save your choice and start setting the date. Press the Up or Down
button to select the proper date. Then press the Power button to save your
choice and start setting the time.
OR

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4. Time: The hour will appear at the top of the display. Adjust the hour with the
Up or Down button until the correct hour is displayed. Press the Power button
to save your choice and set the minutes. Press the Up or Down button to
change to the correct minute. Pressing and holding can help with faster time
adjustment. Press the Power button to save your choice and move to set the
audio.
5. Audio Feature: The meter comes with the meter audio feature enabled. Press Up
or Down button to switch between ON and OFF. The meter will give one short beep
when it is turned on, after sample detection and when the result is ready. The
meter will sound three short beeps to indicate a warning when an error has
occurred. Please check the error number on the display to confirm what kind of
error has occurred.
Year
Month
Date
Hours
Minutes

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6. Meal Marker: The meter comes with the meal marker feature disabled. The
meter allows the user to enable or disable the meal marker option. The words
“On” or “Off” will be displayed on the large center segments of the display and
the before meal icon together with the after-meal icon will be displayed as
shown below.
Press the Up or Down button to switch between turning the meal marker “On”
and “Off”. Press the Power button to confirm your selection.
7. Ketone Indicator: The meter comes with the ketone indicator feature disabled.
Press the Up or Down button to switch between turning the ketone indicator
“On” and “Off”. Press the Power button to confirm your selection.
OR
OR
OR

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When the ketone indicator is enabled, if the test result is higher than 16.7
mmol/L (300 mg/dl) the symbol of "ketone?" will appear on the display.
8. Range Indicator: The meter comes with the Range indicator feature disabled.
Press the Up or Down button to turn the Range indicator “On” or “Off”. Press
the Power button to confirm your selection. When the Range indicator is “Off”,
pressing the Power button (to select) will lead you to the Alarm set up.
When the Range indicator is “On”, pressing the Power button will lead you to level
set up. There are 4 levels of ranges you can set up, it is strongly recommended to
consult with your healthcare specialist to select the ranges. At the level set up,
press the Up or Down button to adjust the level then press the Power button to go
to the Alarm set up mode.
OR