5228BT-M01A1
Rev.date:11/2013
USER GUIDE
Model: 5228B
Explanation of symbols:
Caution (refer to accompanying documents).
Please refer to safety-related notes in the
manual accompanying this instrument.
Consult instructions for use.
Keep away from sunlight.
Authorised representive in the
european community.
Manufacturer
Do not re-use
Use-by date
Batch code
In vitro diagnostic medical device.
Temperature limit
1. Contents
Section Topic Page
1. Contents
2. Introduction
3. Appearance and Key Functions of the meter
4. Alternate Site Testing
5. Safety Information
6. Quick Testing Instructions
Preparing for Testing
7. Installing the Battery
8. Settings (
Date/Time/Alarm/Measuring Unit/
Memory Deletion )
9. Running a Control Solution Test
Blood Testing
10. Running a Blood Glucose Test
11. Recalling the Memory and Viewing the Average
12. Expected Values
13. Transmitting Results
Maintenance
14. Maintenance of Your System
15. Troubleshooting
16. Customer Service
17. Limitations
Important Additional Information
18. Specifications
19. Ordering Supplies
20. Warranty Information
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12-16
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19-21
22-23
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26-27
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NOTE: For information about the name of the manufacturer of
the lancing device and the lancets, please refer to the package
inserts that came with your starter kits.
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2. Introduction to the System
Intended Use / Indications for Use
The SuperCheck Plus Blood Glucose Monitoring System is intended
for use in the quantitative measurement of glucose in fresh capillary
whole blood from the finger and the forearm and venous whole blood.
It is intended for self-testing by people with diabetes mellitus at
home and healthcare professionals as an aid in monitoring the
effectiveness of a diabetes control program.
The SuperCheck Plus Blood Glucose Monitoring System is not
intended for the diagnosis of or screening for diabetes mellitus, nor
for use with neonates.
The alternative site testing (forearm) in this system can only be used
during steady-state blood glucose conditions.
Contents of the System
This User Guide has been prepared to describe the proper use of the
SuperCheck Plus Blood Glucose Monitoring System.
Please read this User Guide and the package insert that comes with
the SuperCheck Plus Glucose Test Strips before testing.The system
is available either as a meter alone or as a kit. If you have a meter only,
you can purchase the system supplies from your system provider.
The starter kit of SuperCheck Plus Blood Glucose
Monitoring System includes the following items:
1. SuperCheck Plus Glucose Meter with 2 AAA batteries
2.U ser Guide
3.L og Book
4.C arrying Case
5. SuperCheck Plus Glucose Test Strips
6. SuperCheck Plus Control Solution (Medium)
7.S terile Lancets
8.L ancing Device
9.P ackage Inserts for Test Strips, Control Solution,
and Lancets/Lancing Device
"A single level control solution (Medium) is provided in the
"Starter Kit," and no control solution is included in the "Meter
Kit". You may purchase any control solutions that you need from
your system provider."
The SuperCheck Plus Glucose Meter uses SuperCheck Plus
Glucose Test Strips. Neither the meter nor the test strips will work when
used with any other brand of glucose products.
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3. Appearance and Key functions
of the meter
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.
1.Test strip slot - When the strip is inserted into the slot, the meter will
automatically turn on.
2. LCD Display - Guide you through the test using symbols and simple messages.
3. M Key - Power ON/OFF, also for memory recalling mode, please refer to
manual for detailed function description.
4. C Key - Setting mode, please refer to manual for detailed function description.
5. RS232 port - Cable connection and data transmitting. The built-in Bluetooth
also supports the data transmitting.
6. Battery Compartment - Where batteries are located.
7. Ejector - Remove used strip.
*If your meter has the backlight feature, it will be on in every operation
to increase the readability in operation, hence help the user to
operate the meter more smoothly.
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4. Alternate Site Testing (AST)
What is AST?
AST is the sampling from anatomical sites (parts of the body)
other than the fingertip (i.e. forearm) to check the blood
glucose levels. This system allows you to test on the forearm
with the equivalent results to fingertip testing.
There are important limitations to AST. Please consult your
healthcare professional before you use AST.
What is the advantage ?
It is more painful feeling when taking blood sample from
fingertips because fingertips have many nerve endings. Other
body sites do not have as many nerve endings, so you will not
feel as much pain as at the fingertip.
When to use AST ?
Medication, stress, illness, food and exercise can affect blood
glucose levels. Capillary whole blood at the fingertip can reflect
test changes faster than capillary blood at other sites of body. If
you test your blood glucose level during or immediately after
a meal, physical exercise or stressful events, take the blood
sample from your fingertip instead of from other sites.
Use AST only:
1. 2 hours or more after taking insulin;
2. 2 hours or more after a meal;
3. 2 hours or more after exercise.
Do not use AST if you are pregnant, or if you are aware that
your glucose level is not as stable as usual, or if you think
you have hypoglycemia (low blood sugar) or hyperglycemia
(high blood sugar).
Do not use AST if you think your blood glucose is low and if
your AST results do not match the way you feel.
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Testing Procedure for AST
1.Please unscrew the lancing device
by turning the end cap counter
clockwise. A clear cap will come
with the package of a meter kit or
a lancing device. The clear cap on
the lancing device will make it easy
for you to get a drop of blood for
AST.
2.Insert a new lancet firmly into the
lancet holder.
3.Twist off the protective top of the
lancet.
4.Close the end cap of the lancing
device and grasp the lancing device
as shown. Slide into locking position.
If necessary, please set the lancing
device for a deeper puncture.
5.Select a soft, fleshy area on your
forearm that is clean and dry, away
from bone and free of visible veins
and hair.
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6.Massage the selected area gently
to increase blood flow to the
puncture site. Clean the test location
with an alcohol wipe or with soap
and water.
7.O pen the test strip vial. Take one
new test strip out of the vial and
quickly recap the vial to keep air
out.
8.Insert the test strip into the meter
while the meter is off. The meter will
turn on automatically. A blinking
blood icon will be displayed on the
screen. If no action is taken in 2
minutes, the meter will turn off
automatically.
9.Press and hold the loaded lancing
device against the forearm for a few
seconds, then press and release the
button.
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10. Wait for a few seconds until the
blood drop forms. Make sure you
have sufficient blood to fill the
small window of the test strip. For
individuals who experience
difficulty in getting sufficient blood
for a test, it may be helpful to rub the
puncture site a little longer before
using the lancing device.
11. Apply your blood to the front
edge (the tip) of the test strip, and
the meter will start counting down
for 5 seconds then display the test
results on the screen.
12. Remove the used strip by hand
or by pushing the ejector button. The
meter will turn off automatically.
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5. Safety Information
Please use this device only for the intended use described
in this user guide.
Before using this system to test your blood glucose
please read instructions thoroughly and practice the test
when you first use this system. Do a quality check on
the system following the instructions and consult
with your healthcare professionals for questions or
problems.
Be aware of the safety of young children or handicapped
persons near you when you conduct a glucose test using
this system.
Please keep the test strip vial away from children. The
test strips and vial cap can present a choking hazard.
Please be cautious when removing the lancet. Take the
lancet out carefully. Always place the protective cap
back on the exposed tip or (if using a twist lancet)
place the cap on a hard surface and push the exposed tip
into the protective cap and discard of properly.
Never try to disassemble the meter in any circumstance.
If your meter is not working properly, or if you need the
Technical Support, please contact your local distributor
for help.
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6. Quick Testing Instructions
1.Insert a new test strip into the meter
while the meter is off. The meter will
turn on automatically. A blinking
blood icon will be displayed on the
screen.
2.Lance the finger and let a blood
drop form.
3.Apply the blood drop to the front
edge of the test strip when the blood
drop icon is still blinking on the
meter. Wait for 5 seconds, and the
meter will display the test result.
4.Remove the used strips by hand or
by pushing the ejector and the meter
will power off.
(For detailed instructions start on page 17 for Control
Solutions and page for Blood Testing.) 19
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7. Installing the battery
1.Turn off the meter by pressing
“M” button and hold for 2 seconds
before replacing the batteries.
Slide down the battery cover on
the back of the meter by pushing
the cover in the direction of the
arrow and put the cover aside.
2.Remove the two used batteries.
3.Insert 2 new batteries with
correct ＋/－ direction.
(Battery:AAA 1.5V 2 Alkaline 24A LR03)
4.Put the battery cover back in
place by pushing the cover in the
opposite direction of the arrow to
close the cover into position.
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Note:
1.I t is suggested that batteries need to be replaced when the battery
icon appears empty. If you keep using the meter, the battery icon
will start flashing and an error message E_3 will appear on the screen.
2.N ote that replacing the battery will not reset the stored testing results.
3 . You need to reset the time and date after the batteries are replaced.
4 .I f there is any unexpected symbol on the display, please follow the
above procedure to replace the batteries again.
5.Please dispose of batteries according to your local ordinances.
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8. Settings (Date / Time / Alarm / Measuring Unit
/ Memory Deletion)
1.Appears with the test result either in mg/dL or in mmol/L.
2.Appears when you recall the memory.
3.Appears when you are in setting mode.
4.Appears for control solution test flag (c).
5.Indicates the meter is ready to take the blood sample when it flashes.
6.Indicates the battery status.
7.Indicates current displayed result is an average.
8.Appears when alarm is on.
9.Month
10.Day
11.Hour
12.Minute
The LCD screen will show as below:
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(1)MeasurementUnits
(6)BatterySymbol
(3)Setting
(2)Memory
(9)Month
(10)Day
(11)Hour
(12)Minute
(4)Testflag
(5)Blooddropicon
(7)DayAverage
(8)Alarm
Reminder
1.
2.
3.
Set the Year - With the meter off, by
pressing the M key and hold for 2
seconds, you will enter the setting
modes, press C key to adjust the year
until the desired year is displayed
and then press the M key to confirm
the year setting. When pressing the C
key, the year will be adjusted in the
range of 2009 to 2029. After the year
setting is confirmed, you will see the
month segment flashing on the screen.
Set the Month - Press C key to adjust
the month until the desired month is
displayed and then press the M key to
confirm the month setting. You will
then see the day segment is flashing
on the screen.
Set the Day - Press C key to adjust
the day until the desired day appears
and then press the M key to confirm
the day setting. You will then see the
hour segment is flashing on the LCD
screen.
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AM
SET
AM
SET
3
AM
SET
Set the Hour - Press C key to adjust the
hour until the desired hour appears on
the screen and then press the M key to
confirm the setting. You will then see
the minute segment is flashing on the
screen.
Set the Minute - Press C key to adjust
the minute until the desired minute
appears on the screen and then press
the M key to confirm the setting. You
will then see an “AL” displayed on the
screen center.
4.
5.
Set the Alarm Reminder - Press C key
to toggle between the alarm reminder
setting and no-setting mode. If you see
the LCD display a small flashing icon
of alarm clock in the lower left corner
with a time segment display, it means
that you are in the alarm setting mode.
If you see only AL without the icon of
the small alarm clock, it means that
you are not in the alarm setting mode.
Press M key to confirm the alarm setting
mode. If you select the alarm setting mode,
alarm clock icon will stop flashing and the
hour of the time segment will start flashing.
Press C key until the desired alarm hour
appears and then press M key to confirm
the hour setting. Then the minute segment
will start flashing. Press C key until the
desired minute appears on the screen and
then press M key to confirm the minute setting.
You will see the measuring unit flashing on the
upper left corner of the LCD display.
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4
PM
SET
5
PM
SET
AM
SET
6.
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Set the measurement unit - Press C
key to toggle between mg/dL and
mmol/L measurement units. Press M
key to confirm the setting. You will
see a “dEL” displayed in the center
of the screen. The unit of
measurement -mmol/L is the
standard unit of measurement in
the Europe. If the meter is to be
sold in the Europe, the unit of
measurement will be set to
mmol/L by default.
Delete Memory - Press C key to
toggle between a flashing “dEL” for
memory deletion and a non-flashing
“dEL”. If you want to delete all
memory, press M key while the
“dEL” is flashing. If you do not
want to delete all memory, press
M key when the “dEL” is not flashing.
7.
8.
Note:
1.When you change the date and time backward, you will not
change the test results in the meter memory.
2.Y ou need to move through the year, month, day, hour, minutes,
alarm, measurement unit, and dEL to save the meter settings and
turn off the meter.
3.T he average readings in the meter memory are calculated from
the results obtained during the 7, 14, 28, 60,and 90 calendar
days preceding the current date and time settings.
Note: Your meter can show results either in “mg/dL” or
“mmol/L”units. It is very important to use the correct unit
of measurement to properly manage your diabetes.
If you live in the Europe, you should use mmol/L; your results will
always have a decimal point. The unit of measurement will be set
to mmol/L by default. If you do not see a decimal point in your test
results, it indicates the measuring unit is in mg/dL.
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9.Running a Control Solution Test
IMPORTANT:
Always make sure you press C key for Control Solution test,
otherwise the control solution test result will be stored in the
memory, and affect yourAVGresults.
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2.Press the C key, and the meter will
display a letter “C” on the upper right
corner of screen, indicating the control
test mode. The test result will not be
stored in the memory.
3.Squeeze a small amount of Control
Solution on a flat surface and apply to
the front edge of the test strip.
4.Wait for 5 seconds, and the meter will
display the result.
5.Remove the used strips by hand or by
pushing the ejector and the meter will
power off.
1. Insert a test strip into the meter while
the meter is off. The meter will turn on
automatically. A blinking blood icon
will be displayed on the screen.
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IMPORTANT!!!
1.You must press 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, the test result will not be
stored in the memory.)
2. Use only SuperCheck Plus Control Solution with
SuperCheck Plus Glucose Meter.
3. SuperCheck Plus 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. SuperCheck Plus Control Solution contains 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.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.
6.Use only for 3 months after first opening. Record the open
date on the Control Solution vial. Discard after 3 months.
7. 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, by shaking
the control solution vial well and carefully following instructions.
Please make sure the test is done within the temperature range.
(2)The Control Solution is expired or contaminated.
(3)The test strips are damaged or outdated.
(4)You may have applied the Control Solution before the blood drop
appears on the screen. This will cause incorrect glucose measurement.
(5)Meter malfunction.
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10.Running a Blood Glucose Test
1.Please unscrew the lancing device
by turning the end cap counter
clockwise.
2.Insert a new lancet firmly into the
lancet holder.
3.Twist off the protective tip of the
lancet.
4.Close the end cap of the lancing
device as shown. Slide into locking
position.
5.Wash your hands in warm, soapy
water. Be sure to rinse and dry well.
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6.Open the test strip vial. Take one
new test strip out of the vial and
recap the vial quickly and firmly.
7.Insert the test strip into the meter
while the meter is off. The meter will
turn on automatically. A blinking
blood icon will be displayed on the
screen. If no action is taken in 2
minutes, the meter will turn off
automatically.
8.Use the adjustable lancing device
or the disposable lancet to take a
blood sample from the fingertip and
let it form a small round blood drop.
To avoid body fluid contamination,
it is recommended that you do not
use the first blood drop for glucose
testing.
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9.Apply a small blood drop to the
front edge of the test strip, and the
blood should be pulled into the
confirmation window before the
meter begins to count down.
Do not push your finger against the
test strip or try to apply a smeared
blood sample.
10.The meter will start counting
down for 5 seconds and your test
result will be displayed on the
screen. Remove the used test strip
by hand or by pushing the ejector
button. The meter will turn off and
the test result is stored auto-
matically.
Important:
1. Never reuse a test strip or a lancet. An “E_5” error
message will be displayed in the center of screen if a
used strip is inserted into the meter.
2. The used strip and lancet will contaminate, please
discard them according to your local ordinances.
3. The used meter should be treated as contaminated
that may carry a risk of infection during measurement.
The battery in this used meter should be removed and
the meter should be disposed in accordance with local
ordinances.
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11. Recalling the Memory and
Viewing the Average
The test results for blood sample will be stored in the memory
automatically. The meter can store up to 500 of the most recent
test results. You can also view the average of test results for
various periods of 7, 14, 28, 60 and 90 days. The control
solution test results will not be stored in the memory.
(Note: Please make sure that you press C key when you
run a Control Solution test, so that the control test result
will not be added to the memory.)
A. Using the Meter Memory
1. With meter off, press M key to turn on the meter. After
a brief full screen display, the meter will display the
total number of test data stored in memory. Then the
screen will display “001” as the sequential number of
the most recent test result in memory. The memorized
test data will be displayed next. If there is no memorized
result in the meter, “---” is displayed. The meter will turn
off after 60 seconds if no action is taken.
2. The screen will display each of the memorized test data
in sequence. Press M and C key to review your test results
in the memory forwards and backwards.
3.T o turn off the meter, press M key for 2 seconds, or the
meter will turn off automatically after 60 seconds if no
activity.
B. Recalling the Test Results from the Meter Memory
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1. To display the average (AVG) test result, please turn meter
off. Press C and M keys at the same time and hold for about 2
seconds, wait for AVG displayed on the screen, then release the
two buttons. The meter will be in the average mode with
“AVG” font displayed.
2.W hen the “AVG” is flashing at the lower left corner of the
screen, the number 7 will be displayed under AVG and the
average of the last 7 days test results will be displayed in the
center of the screen. The number of tests done in the last 7 days
will be also displayed at the lower right corner of the screen.
If you want to see the average of 14, 28, 60 and 90 days, keep
pressing the M key to move the LCD display forward from 7
day average to 90 day average. The average display will move
from 90 days backward to 7 days if you continue to press C
key.
3.P ress the M key and hold for only 2 seconds to exit the recall
mode and turn off the meter, or the meter will automatically
power off after 60 seconds.
4.W hen “---” is displayed, showing that there are no test results
in the memory.
Calculations:
The 7 days average is the average of the last 7 day test results.
The 14 days average is the average of last 14 day test results.
The 28 days average is the average of last 28 day test results.
The 60 days average is the average of last 60 day test results.
The 90 days average is the average of last 90 day test results.
Note:
1.H I/LO results are not stored in the memory.
2.Do not insert the strip into the meter when you want to recall
the test results.
C. Viewing the Average (AVG) of Test Data in Memory
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13.Transmitting Results
1.W ith the meter off, hold the M and C keys down at the same
time for 5 seconds until “PC” is displayed.
2.P ress the C key to start transmitting. The meter will display
a flashing “PC” during the transmission process. When the
“PC” on the screen stops flashing, it indicates the transmission
is completed. The meter will be power off if no action is taken
in 60 seconds or M key is pressed for 2 seconds.
3. Built-in Bluetooth Function
To enable the Bluetooth data transmitting function, press the
C button for 2 seconds when the meter is power off. You'll see
“BLE” on the screen. Then you may work with your APP to
choose either single data transmitting or total data transmitting.
12.Expected Values
1
Reference
SuperCheck Plus meter gives plasma equivalent results.
Before eating < 5.6 mmol/L (100mg/dL)
Two hours after meals < 7.8 mmol/L (140mg/dL)
Blood glucose levels normally will vary from time to time
depending on food intake, medication dosages, health, stress or
exercise. Consult your physician or healthcare professional for
the target glucose value appropriate for you.
Expected plasma blood glucose values for normal, nondiabetic
adults are as follows.
Note:
Glucose Meter allows you to transfer the test
SuperCheck Plus
results stored in its memory to your personal computer. However,
you will need to order software and a Data Download Cable separately
from your distributor."
The software and its data download procedure will come as a CD
in the download cable box. You can also check with your distributor
for the software download option. The meter still keeps the results
in the memory after transmitting.
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Please, treat this meter with proper care, and keep it in
good condition.
1. Store your meter in its case, in a clean dry place at
35.6~86℉(2~30℃).
2. Always clean your meter after use. Wipe and clean
surface of the meter with a soft cloth that has been
slightly dampened with alcohol.
3. Please handle with care and do not drop the meter.
4. If this meter is used by healthcare professional infection
control policies should be strictly followed.
5.The meter has a shelf-life of 2 years.
14.Maintenance of your system
We suggest you should periodically compare the test system
to another test system which is well maintained and monitored
by a healthcare provider .
If there has no response with 90 seconds, the Bluetooth
function will be turned off automatically. For more information,
please refer your APP service.
Note:
1. The meter will not be able to upload data when Bluetooth
function is not turned on.
2. To prevent the accuracy or the interference, the Bluetooth
function will not be able to use during the blood testing.
3. The meter can work with the below APP services:
- Health2sync
- Dr. Cloud
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15.Troubleshooting :
Error messages:
E_1: The temperature is too low.
E_2: The temperature is too high.
E_3: Battery Low.
E_4:Memory damaged.
E_5: The strip is wet or used.
E_6: Error in meter or strip.
E_7:T he blood sample is not sufficient.
HI : The glucose level is too high.
LO: The glucose level is too low.
Following is a summary of all Error Messages. These
messages help to identify certain problems,but do not
appear in all cases when a problem has occurred.
Improper use may cause an inaccurate result without
producing an error message or a symbol.In the event
of a problem,refer to the information in the table
under Solution.
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ProblemPossible CauseSolution
Repeat the test after the
meter and strip are placed in
a warmer environment and
allow the meter to warm up
for a while before retesting.
Test again following the user
guide for correct glucose
measurement process. If you
see HI again, please call your
medical doctor for advice
immediately.
Repeat the test after the
meter and strip are placed in
a cooler environment and
allow the meter to cool down
for a period before retesting.
Please replace the two AAA
batteries.
Please check the test strip to
see if it is damaged or used.
In either case, please discard
the strip and repeat the test
using a new strip.
Repeat the test with a new
test strip. If E_6 continues
to show up on screen, please
call a customer service
representative.
The meter can perform the
glucose measuring without
storing the test results into
the meter's memory. Please
write down the test results
into the data logger before
you call a customer service
representative.
Test again following the user
guide for correct glucose
measurement process. If you
see LO again, please call your
medical doctor for advice
immediately.
The meter is operating
in an ambient
temperature below
10 ℃ or 50℉ which is
the lowest range of
operating temperature.
(1)
The meter displays
an E_1 error
message.
(2)
The meter displays
an E_2 error
message.
The test result is
lower than the
measuring range
of 1.1 mmol/L
(20 mg/dL).
(3) The meter displays
an E_3 error message.
(5)
The meter displays
an E_5 error
message.
(6)
The meter displays
an E_6 error
message.
(8)
The meter displays
HI on screen.
(9)
The meter displays
LO on the screen.
The meter is operating
in an ambient
temperature above
40 ℃ or 104℉ which is
the cap of operating
temperature.
The battery is too low
to operate the meter.
1.If you apply the
sample before blood
drop icon appears on
the screen.
2.The inserted test strip
has been wet or used.
The meter is not
working properly,
either because of a
defective meter or
a defective strip.
The memory chip
of the meter could
be damaged or
malfunctioning.
The test result is
higher than the
measuring range
of 33.3 mmol/L
(600 mg/dL).
(4)
The meter displays
an E_4 error
message.
Please re-test by inserting a
new test strip ensuring an
adequate amount of blood
comes into contact with the
test strip.
(7)
The meter displays
an E_7 error
message.
The blood sample is
not sufficient .
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If you need assistance with your SuperCheck Plus
Glucose Monitoring System, please contact:
Biotest Medical
Corporation
No. 3-2 Chien-kuo Road, TEPZ Tantzu, Taichung 427
Taiwan R.O.C.
TEL: 886-4-2532 6668
E-mail: info@mail.biotestsystems.com
For questions related to your health condition,
please call your doctor or healthcare professional.
16.Customer Service
29
17.Limitations
1. No Neonatal use
Do not use for neonatal blood glucose testing.
2. H ematocrit range
Hematocrit in the range of 20~60% has been shown not to affect the
glucose results. If you do not know your hematocrit level, consult
your healthcare professional.
3. Elevated Cholesterol and Triglycerides
Cholesterol levels up to 12.9 mmol/L (500 mg/dL) and Triglycerides
up to 33.1 mmol/L(1000 mg/dL) has been shown not to affect glucose
results.
4. Interference was observed for therapeutic levels of Glutathione.
5. Constraints
Certain substances occurring in the blood naturally, such as uric acid,
or from normal therapeutic treatments (Ascorbic acid, L-Dopa,
Tolazamide, and Gentisic acid) will not significantly affect results.
However, higher concentrations in blood may cause incorrect results.
6. There are no significant interference in the presence of galactose,
maltose, or fructose observed in blood glucose test.
7. Use only Heparin or EDTA for anticoagulation of fresh capillary or
venous whole blood.
8. Xylose
Do not test blood glucose during or soon after xylose absorption test.
Xylose in the blood can give falsely elevated results.
9. The test strips may be used at altitudes up to 10,744 feet (3,275 m )
without an effect on test results.
10. Persons suffering from severe dehydration should not be tested using
a capillary whole blood sample.
11. Test results below 3.9 mmol/L(70 mg/dL) indicate low blood glucose
(hypoglycemia). Test results greater than 13.3 mmol/L (240 mg/dL)
indicate high blood glucose (hyperglycemia). If you get results below
3.9 mmol/L(70 mg/dL)or above 13.3 mmol/L (240 mg/dL), repeat the
test, and if the results are still below 3.9 mmol/L(70 mg/dL)or above
13.3 mmol/L(240 mg/dL), please consult your healthcare professional
2
immediately.
12. Inaccurate results may occur for individuals experiencing a
hyperglycemic-hyperosmolar state, with or without ketosis.
Critically ill patients should not be tested with a blood glucose meter.
30
18.Specifications
Test: Glucose
Sample: Whole Blood
Principle of the test method: A mperometric,
FAD- glucose dehydrogenase
Test sites: Fingertip, forearm
Measurement time: 5 seconds
Measurement Range: 1 .1~33.3mmol/L ( 20~600 mg/dL).
Batteries: 2 x AAA 1.5 V Alkaline 24A LR03
Operating Condition: 10~40℃(50-104℉)
20~80% RH (non-condensing)
Storage/Transportation Condition:
2~30℃(35.6-86℉), below80% RH
Width: 50 mm
Length: 100 mm
Thickness: 20 mm
Weight: ~72g
Memory: 500 measurement results with date and time
Auto power off after 2 minutes without action when a
strip is inserted, or 60 seconds if there is no strip inserted.
Traceability of glucose monitoring system: The accuracy of
Blood Glucose Monitoring System was
SuperCheck Plus
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 standard: IVD 98/79/EC, EN 61010-1,
EN 61010-2-101, EN 61326-1, EN 61326-2-6, ISO 15197
(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.)
Lancets and lancing device are medical devices under
the Directive 93/42/EEC.
Emergo Europe
Molenstraat 15
2513 BH The Hague
The Netherlands
Manufacturer (Lancets) :
SteriLance Medical (Suzhou) Inc.
No. 68 Litanghe Road, Xiangcheng,
Suzhou 215133, China
31
20. Warranty Information
Your SuperCheck Plus 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 SuperCheck Plus
Glucose Meter or this warranty, please contact:
Biotest Medical Corporation
No.3-2, Chien-kuo Rd., TEPZ Tantzu, Taichung 427,
Taiwan, R.O.C.
E-mail: info@mail.biotestsystems.com
Reference:
1.American Diabetes Association: Diabetes Care, January 2007,
volume 30 (Suppl. 1) S42-S47.
2.American Diabetes Association-Diabetes Forecast
website information :
http://www.forecast. diabetes.org/diabetes-101/hyperglycemia
http://www.forecast.diabetes.org/diabetes-101/ hypoglycemia
To order supplies, please contact the Manufacturer :
Biotest Medical Corporation
No.3-2, Chien-kuo Rd., TEPZ Tantzu, Taichung 427,
Taiwan, R.O.C.
E-mail: info@mail.biotestsystems.com
19.Ordering Supplies
Federal Communication Commission Interference Statement
This equipment has been tested and found to comply with the limits for a
Class B digital device, pursuant to Part 15 of the FCC Rules. These limits
are designed to provide reasonable protection against harmful interference
in a residential installation. This equipment generates, uses and can radiate
radio frequency energy and, if not installed and used in accordance with the
instructions, may cause harmful interference to radio communications.
However, there is no guarantee that interference will not occur in a
particular installation. If this equipment does cause harmful interference to
radio or television reception, which can be determined by turning the
equipment off and on, the user is encouraged to try to correct the
interference by one of the following measures:
-Reorient or relocate the receiving antenna.
-Increase the separation between the equipment and receiver.
-Connect the equipment into an outlet on a circuit different from that
to which the receiver is connected.
-Consult the dealer or an experienced radio/TV technician for help.
FCC Caution: Any changes or modifications not expressly approved by the
party responsible for compliance could void the user's authority to operate
this equipment.
This device complies with Part 15 of the FCC Rules. Operation is subject to
the following two conditions: (1) This device may not cause harmful
interference, and (2) this device must accept any interference received,
including interference that may cause undesired operation.
IMPORTANT NOTE:
Radiation Exposure Statement:
The product comply with the US portable RF exposure limit set forth for an
uncontrolled environment and are safe for intended operation as described
in this manual. The further RF exposure reduction can be achieved if the
product can be kept as far as possible from the user body or set the device to
lower output power if such function is available.
This transmitter must not be co-located or operating in conjunction with any
other antenna or transmitter.
BiotesT Medical Corporation
No. 3-2,Chien-kuo Road,TEPZ Tantzu,
427 Taichung, Taiwan ROC.
Tel : 886-4-25326668
Fax: 886-4-25326528
MEDNET GmbH
Borkstrasse 10,
48163 Münster
Germany
0537
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