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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2
3
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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.)
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8. Using the Check Strip
Check your meter with the check strip when it is new
and whenever you want to perform a quality control
check on the meter.
1.
_ _
Please make sure there is a code key inserted. It does
not matter what code number it is.
2. Insert the “L” side of the check strip as shown below.
The meter will turn on automatically with a beep.
3. After the code number of the code key is displayed,
the meter will start to count down for 15 seconds and
then _ _ will appear with two beeps.
4. Insert the “H” side of the check strip, the meter should
display .
5.This brief test allows you to make sure your
meter is functioning properly.
6.If the meter displays E_4 as an error message,
you may need to wipe and clean the check strip
gently with a soft cloth that has been slightly
dampened with alcohol, and repeat steps 1~4.
Do not get moisture into the test strip slot.
7.If error message E_4 appears again, your meter
is not working correctly. In this case, DO NOT use
the meter for your blood glucose testing.
Contact your local distributor for further assistance.
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PR8898-M01A1
9. Running a Control Test
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2
3
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(1) Insert a strip that has the identical
code with the code key. The code
number of the code key will be
displayed with a beep. Wait until the
blood drop icon appears. Press the C
key, and the meter will display a letter
“C”, on the left hand side of the blood
drop icon, indicating the control test
mode. The test data will not be stored
in the memory.
(2)Squeeze a small amount of Control
Solution on a flat surface and apply
to the front edge of the test strip.
You will hear another beep to let
you know the test is starting.
( )3 Wait for 15 seconds, and the meter
will display the result with two beeps.
IMPORTANT:
Always make sure you press C key for Control Solution test,
otherwise the control solution test result will be memoried and
affect your “AVG” results. Control Test only runs properly
when you use the code key that has the same code number as the
strips. (The strip code number will be printed on the strip vial
label.)
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PR8898-M01A1
Important Control Solution Test Information:
1.You must push the C key to distinguish the control
solution test from the blood glucose test. Do not
perform the blood test in Control Solution mode.
(If you perform the blood test in Control Solution
mode, and the test result will not be memoried.)
2. Use only Smartest Control Solution with Smartest
Glucose Meter.
3.Smartest control solutions are used to check that
the meter and the test strips are working together
as a system and that you are performing the test
correctly.
4.Smartest control solution contain a known amount
of glucose that reacts with Test strips.
The Medium and High level Control Solution are
intended to check the Monitoring system in
different measurement ranges.
5.Control Solution, meter, and test strips should
come to room temperature (20~25℃ or 68~77℉)
before testing.
6.Shake the vial, discard the first drop of control
solution, and wipe off the Dispenser tip to ensure
a good sample and an accurate result.
7. Use only for 90 days after first opening. Record
the discard date (date opened plus 90 days)on the
control solution vial. Discard after 90 days.
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8. Compare your control solution test results with
the expected range printed on the test strip vial
label. If your glucose control results fall outside
the expected range; repeat the test. Results that
repeatedly fall outside the expected range may
indicate:
(1)You may not be doing the test correctly; repeat
the test, carefully following instructions.
(2)Your meter is not coded for the strips you are
using.
(3)The control solution is expired or contaminated.
(4)The test strips are damaged or outdated.
(5)Meter malfunction.
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10. Running a Blood Glucose Test
Unscrew
Insert a new lancet firmly into the
lancet holder.
Twist off the protective top of the
lancet.
the lancing device by
turning the end cap counterclockwise.
Screw the end cap back.
Grasp the lancing device as shown
to twist the dial until you reach your
chosen setting.
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PR8898-M01A1
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Wash your hands in warm, soapy
water. Be sure to rinse and dry well.
Open the test strip vial.
Take one test strip and recap the
vial.
Make sure the code key is inserted,
and the code number of code key is
the same as the code number on the
strip vial. With the meter off, insert
the test strip fully into the meter,
and it will turn on with a beep.
After a “ ” and code number
display, a blood drop icon will be
blinking on the screen.
You are ready to perform a test when
a blood drop icon is flashing.
(The meter will turn off automatically
if no action is taken in about 110
seconds.)
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Note: 1. Never reuse a test strip.
2. Discard the test strip and lancet in a puncture-proof
container with a lid.
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PR8898-M01A1
Prime the lacing device, and press it
firmly against the side of the finger then
push the blue bottom to trigger. Form a
small round drop of blood.
Apply the blood drop at least 1.2
microliter ( actual size) to the front
edge of the test strip, and the blood
should completely fill the confirmation
window before the meter begins to
count down. You will hear another
beep to let you know that the test is
starting.
After 15 seconds, your test result is
displayed with “Mem”. Do not
remove the strip until the result is
displayed. Record the test result
with date in your Daily Log book.
Remove the test strip, the meter
turns off and the test result is stored
automatically.
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11. Using Memory/Recalling Test
Results
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A. Using the Meter Memory
The test result will be stored in the memory automatically
after the reading is displayed.
B. Recalling the Test Results from the Meter Memory
1.Press M key to turn on the meter. After a brief full
display, the last test result is displayed. If there is no
memoried result, “nUL” is displayed and the meter
will turn off after 5 seconds.
2.Press M and C key to review your test results backwards
and forwards.
3.To turn off the meter, press M key for 2 seconds, or the
meter will turn off automatically after 20 seconds.
4.Smartest glucose meter stores the last 1,000 test results
with time and date. When the meter has 1,000 results in
the memory, the oldest result will be deleted
automatically and the newest result is stored as the
first result.
5.To display the average (AVG) test result, while the
meter is off, hold both M and C keys down at the
same time for about 2 seconds, then release.
6.When the AVG is displayed, press the M key to show
the average result for the last 7 days AVG. Continue
pressing the M key to display the prior four 7 days
Average, 7 days Maximum (Max), 7 days Minimum
(Min), 14 days Average and 28 days Average results.
Press C key to view previous results in order.
7.Press the M key for two seconds to exit the recall
mode and turn off the meter.
8.When "nUL" is displayed, there is no data in the
memory.
Calculations:
The 7 days Average is the Average of the last 7 days
test results.
The 14 days Average is the Average of two 7 days
Averages.
The 28 days Average is the Average of four 7 days
Averages.
Note: 1. HI/LO results are stored in the memory, but
are not used in calculating averages.
2. Don't insert the strip into the meter when
you want to recall the test results.
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PR8898-M01A1
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12. Maintenance of your System
This meter should be treated with proper care and kept
it in good condition.
1.Store your meter in the case provided in a clean dry
o o
place at 18~30 C (65~86 F).
2.Always clean the meter after use. Gently wipe and
clean surface of the meter with a soft cloth that has
been slightly dampened with alcohol.
3.Do not drop the meter. If the meter is dropped, please
use the check strip to ensure the meter is working
properly. (Refer to Section 8, Using the Check Strip.)
4.If this meter is used by healthcare professional,
infection control policies should be strictly followed.
13. Troubleshooting
The following is a summary of error messages that
may appear on your meter, as well as a table that
shows possible causes and solutions for certain
problems. Improper use of the system may cause an
inaccurate test result without producing an error
message or symbol. In the event of an error message,
refer to the table below for special problem, causes
and solutions.
Error message
E 1 The meter temperature is below its operating range.
E 2 The meter temperature is above its operating range.
E 3 Low battery. No further tests can be performed.
E_4 The meter is not working properly, or the test strip
is damaged.
HI Test result is higher than 600mg/dL (33.3 mmol/L)
LO Test result is lower than 20mg/dL(1.1mmol/L)
-
-
-
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PR8898-M01A1
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Problem
Possible Cause
The meter will not
turn on when a strip
is inserted.
The meter is defective or
the battery is low.
The meter is defective or
the battery is low.
The meter is defective or
the battery is low.
The test result is below
20 mg/dL (1.1mmol/L).
The meter does not
count down.
The meter display
turns off
abnormally.
"LO" display.
"HI" display.
The control test
result is out of
specified range.
(1) The check strip or
the meter is not
working properly.
(2) The strip is damaged.
The test result is higher
than 600 mg/dL
(33.3mmol/L).
The control solution or
test strip may be
outdated or defective.
The meter displays
"E_4 " as an error
message.
Solution
Replace the battery. If
the meter fails to operate,
Contact your local
distributor.
Call your doctor
immediately and follow
doctor's advice.Test
again.
Call your doctor
immediately and follow
doctor's advice.Test again.
Verify the Control Solution
and strip that have not
expired. If the meter fails
to operate properly, contact
your local distributor.
(1) Wipe and clean the
check strip gently and
try again.
(2) Using the new strip
to perform the test again.
(3) If error message E_4
is still displayed on the
meter, then you can't
perform any more
glucose tests. Please
contact your local
distributor.
Replace the battery. If
the meter fails to operate,
Contact your local
distributor.
Replace the battery. If
the meter fails to operate,
Contact your local
distributor.
14. Customer Service
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PR8898-M01A1
If you need assistance with your
Glucose Monitoring System ,
please contact:
For your health condition related questions, please
call your doctor or healthcare professional.
Smartest
Smart-Code
Progressive Health
Supply & Source Corp.
119 Avenue at the Common, Suite 1
Shrewsbury, NJ 07702
www.progressivehealthsupply.com
TEL:1-888-88PHSSC
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15. Limitations
1.Preservatives
Do not use blood collected in sodium fluoride
tubes.
2.Neonatal use
Do not use for neonatal blood glucose tests.
3.Hematocrit
At normal non-fasting glucose level 70~178
mg/dL (3.9~9.9mmol/L), hematocrit in the
range of 32~56% does not affect the glucose
results.
4.Hemoglobin
Hemoglobin does not affect the glucose test result
at any level tested. Hemoglobin testing was
performed up to 16 g/dL.
5.Elevated Cholesterol and Triglycerides
Cholesterol up to 500 mg/dL (12.9 mmol/L)
and Triglycerides up to 500 mg/dL (5.7 mmol/L)
will not affect glucose result.
6.Medications
Acetylsalicylic acid (Aspirin), ibuprofen and
acetaminophen do not affect the test
results. Dopamine increased the glucose test
result. Ascorbic acid (Vitamin C) decreases the
glucose test result.
Caution:
Persons suffering from severe dehydration should
not be tested using a capillary whole blood sample.
16. Expected Values
The normal fasting glucose range for a non-diabetic adult
in whole blood is 59~99 mg/dL (3.3~5.5 mmol/L). Consult
your physician or healthcare professional for the range
appropriate for you.
If you are experiencing symptoms that are not consistent
with your blood glucose results and you have followed all
instructions in this user guide, call your healthcare
professional. Never ignore symptoms or make significant
changes to your diabetes control programs without speaking
to your healthcare professional.
Test results with Smartest-Smart Code meter are wholeblood-calibrated.
17. Specifications
Test: Glucose
Sample: Whole Blood
Principle of the test method: Amperometric, glucose oxidase.
Measuring Range: 20~600 mg/dL (1.1~33.3mmol/L ).
Measuring Time: 15 seconds
Battery: One CR2032 Button Cell
Operating Range: 10~40℃(50-104℉)
Humidity:20~80% RH
Width: 59 mm.
Length: 88 mm.
Thickness: 25 mm.
Weight:~52g.
Memory: 1000 measurement results with date and time.
Auto power off after 2 minutes without action.
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PR8898-M01A1
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18. Ordering Supplies
To order supplies, please contact your current supplier.
Traceability of glucose monitoring system: The
accuracy of Smartest-Smart Code Blood Glucose
System was assessed by comparing blood results
obtained by patients with those obtained using a
YSI Model 2300 Glucose Analyzer, which is
calibrated by YSI calibrator solution, refer to
NIST SRM (standard reference material) # 917A
Clinical Dextrose.
The device has certified to meet the following
standards:
98/79/EC, EN60601-1+ EN 60601-1-1
ISO15197
(P.S. Please refer to the package insert that came with
your test strips, and you will also find information
on how the system works and on the performance
characteristic reference.)
19. Warranty Information
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PR8898-M01A1
Your Smartest-Smart Code Glucose Meter is warranted
to be free of defects in materials and workmanship for one
year from the date of the original purchase.
This warranty does not cover device failure due to
owner misuse or negligence, or normal wear and tear.
If you have a question about your Smartest-Smart Code
Glucose Meter or this warranty, please contact:
Lancets and Lancing Device are certified by CE 0197
according to EN46002.
Manufacturer :
WuXi XINDA Medical Device Co., Ltd.
No.42 XiXin Rd. ZhangJing. WuXi, P.R. China 214194
SuZhou SPR Medical Devices Development Co., Ltd.
No.32 XinLian Rd., PingJiang, SuZhou. P.R. China 215008
European Representative:
EMDARBV; ljsselburcht 3, Postbus 5486,6802 ElArnhem,
Netherlands.
Tel: +86 (510) 379 3149/ (512) 6721 7661
Progressive Health
Supply & Source Corp.
119 Avenue at the Common, Suite 1
Shrewsbury, NJ 07702
www.progressivehealthsupply.com
TEL:1-888-88PHSSC
Progressive Health
Supply & Source Corp.
119 Avenue at the Common, Suit e 1, S hrewsbury, NJ 07 702
www.progressivehealthsupply.com
TEL:1-888-88PHSSC
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