PHSS Smartest Smart Code User manual

Blood Glucose Monitoring System
PR8898-M01A1
USER GUIDE

Explanation of symbols:
Do not re-use
Use by / Expiry date
Lot number
For in vitro diagnostic use.
Do not ingest!
This product fulfills the requirements
of Directive 98/79/EC on in vitro diagnostic
medical devices.
Temperature limitation
Caution (refer to accompanying documents).
Please refer to safety-related notes in the
manua accompanying this instrument.
LOT
IVD

1. Contents
Section Topic Page
01. Contents
02. Introduction
03. Smartest-Smart Code Glucose Meter
04. Quick Testing Instructions
Preparing for Testing
05. Installing the Battery
06. Setting the Time/Date/Memory Deletion
07. Coding the Meter
08. Using the Check Strip
09. Running a Control Solution Test
Blood Testing
10. Running a Blood Glucose Test
11. Using Memory / Recalling Test Results
Maintenance Problem-Solving
12. Maintenance of your System
13. Troubleshooting
14. Customer Service
15. Limitations
Important Additional Information
16. Expected Values
17. Specifications
18. Ordering Supplies
19. Warranty Information
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11-13
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PR8898-M01A1
2. Introduction
Why test for glucose?
lucose test system is intended to measure
glucose in whole blood.This glucose measurement is used in
self-monitoring of glucose levels and is intended for use outside
the body, i.e.,for in vitro diagnostic use only.
If you are diagnosed with diabetes, your doctor will let you
know what you should do to manage your diabetes. Your
doctor may suggest glucose monitoring. You can use the
information from glucose testing to help follow your doctor's
instructions.
Blood glucose results less than 50mg/dL (2.8 mmol/L) or more
than 250 mg/dL (13.9 mmol/L) indicate that there may be a
serious health problem. In these cases, contact your doctor and
make sure you follow his or her advice. It is important to make
no changes in your diet or medication except on your doctor's
advice.
This User Guide has been prepared to describe the proper use
of Blood Glucose Monitoring System.
Please read this User Guide and the package insert that comes
with Smartest Glucose Test Strips carefully before testing.
To begin testing, you will need the following items:
1. Glucose Meter
2. Battery
3. Smartest Glucose Test Strips with Code Key
4. Check Strip
5. Lancets and Lancing Device
6. Smartest Control Solution
Glucose Meter uses Smartest Test Strips.Neither
the meter nor the test strips will work when used with any other
brand of glucose testing products.
Smartest-Smart Code G
Smartest
Smartest-Smart Code
Smartest-Smart Code
(Smartest-Smart Talk & Smart Code meters can only be used with
Smartest Test Strip with Code Key.)

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3. Glucose MeterSmartest-Smart Code
(6)Battery
(7)Code Key Slot
(1)Test Strip Slot
(2)Display
(3)Advance Button
(4)Memory/Enter Button
The principle of the method
When glucose reacts with the reagents on the test strips, an electrical current is
produced, which is proportional to the glucose concentration in the blood sample.
The glucose concentration is calculated by the meter and based on the current
measured.

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4. Quick Testing Instructions
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(The detailed instructions start on page 11 for Control Solution
Testing and Blood Testing are shown on page 14 & page 16.)
(1) Inserting the code key sets the
meter to match the test strips.
(Please check if the code number
of the code key and test strip vial
are identical. Remember to change
the code key every time you open a
new box of test strip.)
(2) Insert a new strip into the meter
when it is off. The meter will turn on
with a beep. After a brief “ ”
display,the code number of the code
key will be displayed after 4 seconds.
A blinking blood drop icon will appear
on the screen.
(3) Place the cocked lancing device or
single use disposable lancet against
the side of the finger and press the
trigger.
(4) Apply the blood drop to the front
edge of the test strip when “ “ symbol
appears on the meter, and you will hear
another beep to let you know that the
test is starting.
Wait for 15 seconds, and the meter
will display the result with two beeps.
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PR8898-M01A1

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5. Installing the Battery
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1.
2.
3.
4.
5.
Turn off the meter by pressing
“M” button for 2 seconds before
replacing the battery.
Open the battery cover on the back
of the meter by pushing the tab in
the direction of the arrow and
pulling the cover up.
Remove the old battery.
Insert the new battery with + side up.
Put the battery cover back in place
and snap it closed.
Note:
1. Always turn off the meter before you
replace the battery.
2.Note that replacing the battery will not
reset the stored testing results or the
setting of the meter EXCEPT time and date.
3.
4.If there is any unexpected symbol on the
display, please follow the above procedure
to replace the battery again.
5.Please dispose of meter battery according
to your local ordinances.
Remember to reset the time and date after
replacing the battery.

Blood drop
icon
Units
Test
Result
Battery
Symbol Setting
Code
Number
Memory
Month
Hour Minute
Day
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6. Setting the Time / Date / Memory
Deletion
PR8898-M01A1
The M key is used to set the display. The C key is used to
adjust or change the display. Press C key to adjust until
the display is as desired, then press M to set.
1.To enter the initial display, press the M key and hold for
three seconds until hour is flashing on the right bottom
corner . The meter is now in the SET mode.
2..When the hour is displayed :
a.Adjust Hour-Press C key to adjust, then M key to set.
b.Adjust Minute-Press C key to adjust, M key to set.
c.Adjust Time/Mode (24:00/am pm)-Press C to adjust,
M key to set.
d.Adjust Year-Press C key to adjust, M key to set.
e.Adjust Month-Press C key to adjust, M key to set.
f.Adjust Date-Press C key to adjust, M key to set.
g.Adjust Unit of Measure(mg/dL,mmol/L)-press C key
to adjust, M key to set.
h.When “dEL” appears on the display, press M key
to finish Time and Date setting.

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Note:
1. When you change the date and time to an
advance date and time, all the test results
including average readings in the meter memory
will be deleted. The meter will only display the
latest test results after date and time are changed.
2.When you change the date and time to a
backward date and time, all the test results in the
meter memory will not be changed.
3.
4.The average readings in the meter memory
are calculated from the results obtained during
the 7, 14 and 28 calendar days preceding the
current date and time settings.
You need to move through the hour, minute,
time format, year, month, day, unit of measure,
dEL, and the software version to save the meter
settings and turn off the meter.
3.Memory Deletion : When “dEL” appears on the
display, press C key to start Memory deletion.
“dEL” and “Mem” will start to flash. Press M key
to delete all the memory records. If you don't want
to delete all the memory records, press C key to stop
“dEL” and “Mem” flashing, and press M key to leave.
4. After Time/Date/Unit of Measure/Memory Deletion
is done, the software version of this meter will be
displayed on the right bottom corner (e.g. 7:00).
The meter will turn off automatically after 2 seconds.

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7. Coding the Meter
PR8898-M01A1
Important:
To code the meter by inserting the code key that comes
with the test strips or starter kits to set the meter to
match the test strip. Remember to change the code key
every time you open a new box of test strip.
If there is a code key in the meter, remove it.
3.Find the new Code key in the strip box or starter kit.
4.Insert the code key into the meter (as picture).
5.Make sure that the code number on the meter display
matches the code number on the test strip vial.
Failure to code the meter correctly will cause
inaccurate test results.
6.Leave the code key in the meter until you open the
next new box of test strips.
7.Once the code is set, you may begin testing. (Refer
to page 11 for Control Solution Testing and page
14~16 for Blood Glucose Testing.)
1.Make sure the meter is off.
2.
(Note:If you see a code “ ” with date and time on
the display, plese insert a code key into the meter.)