Clever Choice Auto-Code Pro Owner`s manual

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Distributed by
Simple Diagnostics
P.O. Box 128, Williston Park, NY 11596 USA
24-HOUR TOLL-FREE TELEPHONE ASSISTANCE
1-877-DIABETK 1-877-342-2385
www.SimpleDiagnostics.com
For in vitro diagnostic use only
Read instructions before use
For self-testing
Blood Glucose Monitoring System
OWNER'S
MANUAL
Dec. 2009 Version 1.0
311-4267100-001
Dear CLEVER CHOICE Auto-Code Pro’s System
Owner:
Thank you for purchasing the CLEVER CHOICE Auto-Code Pro
Blood Glucose Monitoring System. This manual provides important
information to help you to use the system properly. Before using this
product, please read the following contents thoroughly and carefully.
Regular monitoring of your blood glucose levels can help you and
your doctor gain better control of your diabetes. Due to its compact
size and easy operation, you can use the CLEVER CHOICE AutoCode Pro Blood Glucose Monitoring System to easily monitor your
blood glucose levels by yourself anywhere, any time.
If you have other questions regarding this product, please contact
the place of purchase, or call our 24-hour toll free number 1-877DIABETK (1-877-342-2385).
IMPORTANT SAFETY PRECAUTIONS
READ BEFORE USE
1. Use this device ONLY for the intended use described in this
manual.
2. Do NOT use accessories which are not specified by the manufacturer.
3. Do NOT use the device if it is not working properly or or if it is
damaged.
4. Do NOT use the equipment in places where aerosol sprays are
being used, or where oxygen is being administered.
5. Do NOT under any circumstances use the device on newborns,
infants, or people who cannot communicate.
6. This device does NOT serve as a cure for any symptoms or
diseases. The data measured is for reference only. Always consult
your doctor to have the results interpreted.
7. Before using this device to test blood glucose, read all instructions
thoroughly and practice the test. Carry out all the quality control
checks as directed.
8. Keep the device and testing equipment away from young children.
Small items such as the battery cover, batteries, test strips, lancets and vial caps are choking hazards.
9. 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.
10. Do not use this instrument in close proximity to sources of strong
electromagnetic radiation, as these may interfere with the proper
operation.
KEEP THESE INSTRUCTIONS IN A SAFE PLACE
TABLE OF CONTENTS
IMPORTANT SAFETY PRECAUTIONS
5
BEFORE YOU BEGIN
8
Important Information
8
Intended Use
9
Test Principle
9
Contents of System
10
Meter Overview
11
Screen Display
12
Test Strip
13
Setting the Meter
14
THE FOUR MEASURING MODES
18
CONTROL SOLUTION TESTING
19
Performing a Control Solution Test
TESTING WITH BLOOD SAMPLE
19
22
Overview of the Lancing Device
22
Setting up the lancing device
23
Preparing the puncture site
24
Alternative Site Testing
26
Performing a blood glucose test
28
METER MEMORY
31
Reviewing Test Results
31
Reviewing Blood Glucose Day Average Results
32
DOWNLOADING RESULTS ONTO A COMPUTER
34
MAINTENANCE
35
Battery
35
Caring for Your Meter
37
Caring for Your Test Strips
37
Important Control Solution Information
38
SYSTEM TROUBLESHOOTING
39
Result Readings
39
Error Messages
40
Troubleshooting
41
DETAILED INFORMATION
42
Reference values
42
Comparing Meter and Laboratory Results
43
SPECIFICATIONS
45
BEFORE YOU BEGIN
Important Information
Severe dehydration and excessive water loss may cause readings
which are lower than actual values. If you believe you are suffering
from severe dehydration, consult a healthcare professional immediately.
If your blood glucose results are lower or higher than usual, and
you do not have symptoms of illness, first repeat the test. If you
have symptoms or continue to get results which are higher or
lower than usual, follow the treatment advice of your healthcare
professional.
Use only fresh whole blood samples to test your blood glucose.
Using other substances will lead to inaccurate results.
If you are experiencing symptoms that are inconsistent with your
blood glucose test results and you have followed all the instructions given in this owner’s manual, contact your healthcare professional.
Inaccurate results may occur in severely hypotensive individuals or
patients who are in shock. Readings which are lower than actual
values may occur for individuals in a hyperglycemic-hyperosmolar
state, with or without ketosis. Please consult your healthcare
professional before use.
8
Intended Use
This system is intended for use outside the body (in vitro diagnostic
use) by people with diabetes at home and by health care professionals in clinical settings as an aid to monitoring the effectiveness
of diabetes control. It is intended to be used for the quantitative
measurement of glucose (sugar) in fresh whole blood samples (from
the finger, palm, forearm, upper arm, calf and thigh).
It should not be used for the diagnosis of diabetes, or testing on
neonates.
Test Principle
Your system measures the amount of sugar (glucose) in whole
blood. The glucose testing is based on the measurement of electrical
current generated by the reaction of glucose with the reagent of the
strip. Your meter measures the current, calculates the blood glucose
level, and displays the result. The strength of the current produced
by the reaction depends on the amount of glucose in the blood
sample.
9
Contents of System
Your new CLEVER CHOICE Auto-Code Pro system kit includes:
Meter
Daily Log Book
Owner’s Manual
Warranty Card
Storage case
Sterile Lancets
Quick Start User Guide
One CR2032 Battery
Quick Start User Guide
Test strip and control solution are not included in the kit (please
check the contents on your product box). They can be purchased
separately. Please make sure you have those items needed for a
blood glucose test beforehand.
NOTE
If any items are missing from your kit or opened prior to use,
please contact local customer services or place of purchase for
assistance.
10
Meter Overview
Top
Left Side
Front
Right Side
Back
Rear
DISPLAY SCREEN
BATTERY COMPARTMENT
M BUTTON
Enter the meter memory and silence
a reminder alarm.
TEST STRIP EJECTOR
TEST SLOT
Insert test strip here to turn the meter
on for testing.
DATA PORT
Download test results with a cable
connection.
Eject the used strip by pushing up this
button.
UP BUTTON &
TON
DOWN BUT-
Select or change information.
S BUTTON
Enter and confirm the meter settings.
11
Screen Display
12
Measurement mode
Day average
Blood drop symbol
Low battery symbol
Test strip symbol
Memory symbol
Error message
Ketone warning
Test result
Control solution mode
Date
Measurement unit
Time
Reminder alarms
Test Strip
Absorbent Hole
Apply a drop of blood here and the blood will be drawn
in automatically.
Confirmation window
Confirm if enough blood has been applied to the absorbent hole of the test strip.
Test Strip Handle
Hold this part to insert the test strip into the slot.
Contact Bars
Insert this end of the test strip into the test slot.
Attention!
Test results might be wrong if the contact
bar is not fully inserted into the test slot.
The front side of the test strip should face
up when inserting the test strip.
Front
Back
NOTE
The CLEVER CHOICE Auto-Code Pro meter should only be
used with CLEVER CHOICE Auto-Code Pro Test Strips. Using
other test strips with this meter can produce inaccurate results.
13
Setting the Meter
Before using your meter for the first time or if you change the meter
battery, you should check and update these settings. Make sure you
complete the steps below and have your desired settings saved.
Entering the setting mode
Start with the meter off (no test strip inserted).
Press and firmly hold for 3 seconds until the
meter turns on.
1. Setting the date
With the year flashing, press
rect year appears. Press .
or
or
With the month flashing, press
rect month appears. Press .
With the day flashing, press
day appears. Press .
14
or
until the cor-
until the cor-
until the correct
2. Setting the time format
Press and release
24h. Press .
or
to select the desired time format --- 12h or
3. Setting the time
With the hour flashing, press
rect hour appears. Press .
With the minute flashing, press
rect minute appears. Press .
or
until the cor-
or
until the cor-
4. Deleting the Memory
With “dEL” and a blinking “ ” symbol on the
display, press and select “no” to keep the results
in memory.
15
If you would like to delete ALL the results, press or and select
“Yes” then press to confirm. “OK” and “ ” are displayed on the
meter, which indicates that all data stored is deleted.
5. Setting the Reminder Alarm
You may set up any or all of the reminder alarms (1-4). The meter
, press or to turn on or turn off to
displays “On” or “OFF” and
set the first reminder alarm.
Press or to select “On”, then press to set the hour. When the
hour is flashing, press or to add an hour. Press to confirm
and go to minutes, press or to add one minute. Press to
confirm and go to the next alarm setting.
16
If you do not want to set an alarm, press
to skip this step.
If you want to turn off an alarm, find the alarm number by pressing
in the setting mode, press or to change from “ON’ to “OFF”.
At the time of your alarm, the meter will beep and automatically turn
on. You can press to silence the alarm and insert a test strip to
begin testing. If you do not press , the meter will beep for 2 minutes then switch off. If you do not want to test at this time, press to
switch off the meter.
Congratulations! You have completed all settings!
NOTE
These parameters can ONLY be changed in the setting mode.
If the meter is idle for 3 minutes during the setting mode, it will
switch off automatically.
17
THE FOUR MEASURING MODES
The meter provides you with four modes for measuring General, AC,
PC and QC.
Modes
Use when
General (displays as “Gen”)
any time of day without regard to time since
last meal
AC
no food intake for at least 8 hours
PC
2 hours after a meal
QC
testing with the control solution
You can switch between each mode by:
1. Start with the meter switched off. Insert a test
strip to turn on the meter, the screen will display
flashing blood drop and “Gen”.
2. Press M to switch between General, AC, PC and QC.
18
CONTROL SOLUTION TESTING
CLEVER CHOICE Control Solution contains a known amount of
glucose that reacts with test strips and is used to ensure your meter
and test strips are working together properly.
Do a control solution test when:
you first receive the meter,
at least once a week to routinely check the meter and test strips,
you begin using a new vial of test strips,
you suspect the meter or test strips are not working properly,
your blood glucose test results are not consistent with how you
feel, or if you think the results are not accurate,
practicing the testing process, or
you dropped or think you have damaged the meter.
Performing a Control Solution Test
1. Insert the test strip to turn on the meter
Insert the test strip into the meter. Wait for the meter to display the
test strip and blood drop symbol.
19
2. Press
tion test
to mark this test as a control solu-
With “QC” displays, the meter will not store your
test result in memory. If you press again, the
“QC” will disappear and this test is no longer a
control solution test.
WARNING
When doing the control solution test, you have to mark it so that
the test result will not be stored in the memory. Failure to do so
will mix up the blood glucose test results with the control solution
test results in memory.
3. Apply Control Solution
Shake the control solution vial thoroughly before
use.
Squeeze out a drop and wipe it off, then squeeze
another drop and place it on the tip of the vial cap.
Hold the meter to move the absorbent hole of test strip to touch the
drop. Once the confirmation window fills completely, the meter will
begin counting down.
To avoid contaminating the control solution, do not directly apply
control solution onto a strip.
20
4. Read and Compare the Result
After counting down to 0, the test result
of control solution will appear on the
display. Compare this result with the
range printed on the test strip vial and
it should fall within this range. If not,
please read instructions again and
repeat the control solution test.
Normal
109~165
Out-of-range results
If you continue to have test results fall outside the range printed on
the test strip vial, the meter and strips may not be working properly.
Do NOT test your blood. Contact the local customer service or place
of purchase for help.
NOTE
The control solution range printed on the test strip vial is for
control solution use only. It is not a recommended range for
your blood glucose level.
See the Maintenance section for important information about
your control solutions.
21
TESTING WITH BLOOD SAMPLE
Overview of the Lancing Device
Lancet Holder
Cocking Control
Release Button
Depth Indicator
3
4
5
A Clear Cap
Arrow
Adjustable Tip
If your lancing device differs from the one shown here, please refer
to the manufacturer’s manual to ensure proper usage.
NOTE
To reduce the chance of infection:
Never share a lancet or the lancing device.
Always use a new, sterile lancet. Lancets are for single use
only.
Avoid getting hand lotion, oils, dirt, or debris in or on the lancets and the lancing device.
22
Setting Up the Lancing Device
Screw off the cap of the lancing device. Insert
a lancet into the lancet holder and push down
firmly until it is fully in place.
Twist the protective disk until it separates from
the lancet.
4 5
23
Replace the lancing device cap. Turn the cap
until it is snug but not too tight.
The adjustable tip offers 5 levels of skin penetration. Twist the adjustable tip in either direction until the number lines up with the arrow:
1-2 for soft or thin skin,
23
4
3 for average skin,
5
Slide the cocking control back until it clicks.
If it does not click the device may have been
cocked when the lancet was inserted.
23 4 5
4-5 for thick or calloused skin.
The lancing device is now ready for use. Set aside for later use.
23
Preparing the Puncture Site
Stimulating blood perfusion by rubbing the puncture site prior to
blood extraction has a significant influence on the glucose value
obtained.
Blood from a site that has not been rubbed exhibits a measurably
different glucose concentration than blood from the finger. When the
puncture site was rubbed prior to blood extraction, the difference
was significantly reduced.
Please follow the suggestions below before obtaining a drop of
blood:
Rub the puncture site for about 20 seconds before penetration.
Use a clear cap (included in the kit) while setting the lancing
device.
Wash and dry your hands before starting.
Select the puncture site either at the fingertips or another body
part (please see section “Alternative Site Testing”(AST) on how to
select the appropriate sites).
Clean the puncture site using cotton moistened with 70% alcohol
and let it air dry.
24
23
4 5
Fingertip testing
Hold the lancing device firmly against the side
of your finger. Press the release button. You
will hear a click, indicating that the puncture is
complete.
Blood from sites other than the fingertip
A clear cap, together with the kit, makes it
easier to get a drop of blood for AST. When you
want to obtain blood from sites other than the
finger, replace the lancing device cap with the
clear cap. Turn the clear cap until it is snug but
not too tight, and then slide the cocking control
back until it clicks.
NOTE
Choose a different spot each time you test. Repeated punctures at the same spot may cause soreness and calluses.
Please consult your health care professional before you begin
AST.
It is recommended to discard the first drop of blood as it might
contain tissue fluid, which may affect the test result.
25
Alternative Site Testing
IMPORTANT:
There are limitations with AST (Alternative Site Testing).
Please consult your health care professional before you perform AST.
What is AST?
Alternative site testing (AST) means
that people use parts of the body other
than the fingertips to check their blood
glucose levels. This system allows you
to test on the palm, the forearm, the
upper arm, the calf or the thigh with
results equivalent to fingertip testing.
What is the advantage?
Fingertips feel pain more readily
because they are full of nerve endings
(receptors). At other body sites, since
nerve endings are not so condensed,
you will not feel as much pain as on
the fingertips.
When to use AST?
Food, medication, illness, stress and exercise can affect blood glucose levels. Capillary blood at fingertip reflects these changes faster
than capillary blood at other sites. Thus, when testing blood glucose
during or immediately after meal, physical exercise, or any other
event, take the blood sample from your finger only.
26
We strongly recommend you perform AST ONLY at the following
times:
In a pre-meal or fasting state (more than 2 hours since the last
meal).
Two hours or more after taking insulin.
Two hours or more after exercise.
Do NOT use AST if:
You think your blood glucose is low.
You are unaware of hypoglycemia
You are testing for hyperglycemia
Your AST results do not match the way you feel.
Your routine glucose results are often fluctuating.
27
Performing a Blood Glucose Test
1. Insert the test strip to turn on the meter
Wait for the meter to display the test strip and blood drop symbol.
2. Select the appropriate measurement mode by pressing
For selecting the measurement mode of AC, PC, or Gen, please
refer to the “THE FOUR MEASURING MODES” on page 16.
3. Obtaining a blood sample
Use the prior set lancing device to puncture
your desired site. After penetration, discard the
first drop of blood with a clean cotton swab.
Gently squeeze the punctured area to obtain
another drop of blood. Be careful NOT to smear
the blood sample.
The volume of blood sample must be at least
0.5 microliter (μL) of volume. ( actual size).
4. Apply the Sample
Hold the blood drop to touch the absorbent hole
of the test strip. Blood will be drawn in and after
the confirmation window is completely filled, the
meter begins counting down.
28
.
NOTE
Do not press your puncture site against the test strip or try to
smear the blood.
If you do not apply a blood sample to the test strip within 3
minutes, the meter will automatically turn off. You must remove
and reinsert the test strip to start a new test.
The confirmation window should be filled with blood before the
meter begins to count down. NEVER try to add more blood to
the test strip after your drop of blood has moved away. Discard
the used test strip and retest with a new one.
If you have trouble filling the confirmation window, please contact your health care professional or the local customer service
for assistance.
5. Read Your Result
The result of your blood glucose test will appear
after the meter counts down to 0. This blood
glucose result will automatically be stored in the
memory.
29
6. Eject the used test strip and remove the
lancet
To eject the test strip, point the strip at a disposal container for sharp objects. The meter will
switch itself off automatically after the test strip
is ejected.
Always use caution when removing the
lancet.
Take the lancet out by hand carefully. Place the
disk on a hard surface and push the exposed
tip into the protective disk.
WARNING
The used lancet and test strip may be biohazards. Please discard them carefully according to your local regulations.
30
METER MEMORY
Your meter stores 450 the most recent blood glucose test results
along with respective dates and times in meter memory. To enter the
meter memory, start with the meter switched off.
Reviewing Test Results
1. Press and release
.
will appear on the display. Press again, and
the first reading you see is the last blood glucose
result along with date, time and the measurement
mode.
2. Press to recall the test results stored in the
meter each time you press.
3. Exit the meter memory
After the last test result, press
meter will be turned off.
again and the
NOTE
If the meter is left idle for more than 5 seconds
after entering the memory mode, the meter then
will display the following message on the LCD.
This indicates that you can insert a test strip and
initiate a blood glucose test.
31
Reviewing Blood Glucose Day Average Results
1. Press and release
When appears on the display, keep pressing for 3 seconds until
the blinking “
” appears. Release and then your 7-day average
result measured in general mode will appear on the display.
2. Press to review 14-, 21-, 28-, 60- and 90- day average results
stored in each measurement modes in the order of Gen, AC, then
PC.
For example:
32
2. Exit the meter memory
Keep pressing
test result.
and the meter will turn off after displaying the last
NOTE
Any time you want to exit the memory, keep pressing for 5
seconds or leave it without any action for 3 minutes. The meter
will switch off automatically.
Control solution results are NOT included in the day average.
If using the meter for the first time, “---“ displays when you
recall the test results or review the average result. It indicates
that there is no test result in memory.
33
DOWNLOADING RESULTS ONTO A
COMPUTER
You can use your meter with a USB cable and the Health Care Software System to view your test results on your personal computer.
To learn more about the Health Care Software System or to obtain a
USB cable separately, please contact local customer services or the
place of purchase for assistance.
1. Obtaining the required cable and installing the software
To download the Health Care Software System, please visit Simple
Diagnostics website at http://www.SimpleDiagnostics.com
2. Connecting to a personal computer
Connect the cable to a USB port on
your computer. With the meter switched
off, connect the other end of the cable
to the meter data port. “PC” will appear
on the meter display, indicating that the
meter is in communication mode.
3. Data transmission
To transmit data, follow the instructions provided with the software.
Results will be transmitted with date and time. Remove the cable
and the meter will automatically switch off.
WARNING
While the meter is connecting to the PC, it will be unable to
perform a blood glucose test.
34
MAINTENANCE
Battery
Your meter comes with one 3V CR2032 lithium battery.
Low Battery Signal
The meter will display one of the messages below to alert you when
the meter power is getting low.
1. The
symbol appears along with display
messages:
The meter is functional and the result remains accurate, but it is time to change the battery.
2. The
low:
symbol appears with E-b, Error and
The power is not enough to do a test. You must
change the battery immediately.
LOW
Replacing the Battery
To replace the battery, make sure that the meter is turned off.
1. Press the edge of the battery cover and lift it up to remove.
2. Remove the old battery and replace with one 3V CR2032 lithium
battery.
3. Close the battery cover. If the battery is inserted correctly, you will
hear a “beep” afterwards.
35
CR2032
CR2032
BATTERY
CR2032
BATTERY
BATTERY
NOTE
Replacing the battery does not affect the test results stored in
the memory.
As with all small batteries, these batteries should be kept away
from small children. If swallowed, promptly seek medical assistance.
Batteries might leak chemicals if unused for a long time. Remove the batteries if you are not going to use the device for an
extended period (i.e. 3 months or more).
Properly dispose of the batteries according to your local environmental regulations.
36
Caring for Your Meter
To avoid the meter and test strips attracting dirt, dust or other contaminants, please wash and dry your hands thoroughly before use.
Cleaning
1. To clean the meter exterior, wipe it with a cloth moistened with tap
water or a mild cleaning agent, then dry the device with a soft and
dry cloth. Do NOT flush with water.
2. Do NOT use organic solvents to clean the meter.
Meter Storage
Storage condition: -4°F~140°F (-20°C~60°C), below 95% relative
humidity.
Always store or transport the meter in its original storage case.
Avoid dropping and strong impact.
Avoid direct sunlight and high humidity.
Caring for Your Test Strips
Storage condition: 39.2°F~104°F (4°C~40°C), below 85% relative
humidity. Do not freeze.
Store your test strips in their original vial only. Do not transfer to
other container.
Store test strip packages in a cool and dry place. Keep away from
direct sunlight and heat.
After removing a test strip from the vial, immediately close the vial
cap tightly.
Touch the test strip with clean and dry hands.
Use each test strip immediately after removing it from the vial.
Write the opening date on strip vial label when you first opened it.
Discard remaining test strips after 3 months.
37
Do not use test strips beyond the expiration date. This may cause
inaccurate results.
Do not bend, cut, or alter a test strip in any way.
Keep the strip vial away from children since the cap and the test
strip may be a choking hazard. If swallowed, promptly see a doctor
for help.
For further information, please refer to the test strip package insert.
Important Control Solution Information
Use only CLEVER CHOICE control solutions with your meter.
Do not use the control solution beyond the expiration date or 3
months after first opening. Write the opening date on the control
solution vial and discard the remaining solution after 3 months.
It is recommended that the control solution test should be done at
room temperature (68°F-77°F/20°C-25°C). Make sure your control
solution, meter, and test strips are at this specified temperature
range before testing.
Shake the vial before use, discard the first drop of control solution,
and wipe off the dispenser tip to ensure a pure sample and an accurate result.
Store the control solution tightly closed at temperatures between
36°F and 86°F (2°C to 30°C). Do NOT freeze.
38
SYSTEM TROUBLESHOOTING
If you follow the recommended action but the problem persists, or
error messages other than the ones below appear, please call your
local customer service. Do not attempt to repair by yourself and
never try to disassemble the meter under any circumstances.
Result Readings
MESSAGE
WHAT IT MEANS
Appears when your result is below measurement limit,
which is less than 20 mg/dL (1.1 mmol/L).
This indicates hypoglycemia (low blood glucose). You
should seek medical assistance immediately.
Appears when your result is equal to or higher than 240
mg/dL (13.3 mmol/L). This indicates the possibility of
ketone accumulation for type 1 diabetes. Please seek
medical assistance immediately.
Appears when your result is higher than the limit of measurement, which is higher than 600 mg/dL (33.3mmol/L).
This indicates hyperglycemia. You should seek medical
assistance immediately.
39
Error Messages
MESSAGE
WHAT DOES
METER SAY?
WHAT IT
MEANS
ACTION
Battery is dead.
Please replace.
Appears when
the batteries
cannot provide
enough power for
a test.
Replace the batteries immediately.
Test strip has
been used.
Please replace.
Appears when a
used test strip is
inserted
Repeat the test
with a new test
strip.
Repeat the test
with a new test
strip.
Problem in operation.
Test strip has
been removed
during testing.
Appears when
test strip is
removed while
counting down.
Repeat the test
with a new test
strip.
Appears when
ambient temperature is below
system operation
range.
System
operation range
is 10°F~40°F
(50°C~104°C ).
Room temperature is out of
range. Thus unable to measure.
40
If the meter still
does not work,
please contact
the customer
service for assistance.
System error.
Appears when
ambient temperature is above
system operation
range.
Repeat the test
after the meter
and test strip are
in the above temperature range.
Troubleshooting
1. If the meter does not display a message after inserting a test strip:
POSSIBLE CAUSE
WHAT TO DO
Battery exhausted.
Replace the battery.
Test strip inserted upside down or
incompletely.
Insert the test strip with contact bars
end first and facing up.
Defective meter or test strips.
Please contact customer services.
2. If the test does not start after applying the sample:
POSSIBLE CAUSE
WHAT TO DO
Insufficient blood sample.
Repeat the test using a new test
strip with larger volume of blood
sample.
Defective test strip.
Repeat the test with a new test strip.
Sample applied after automatically
shutoff (2 minutes after last user
action).
Repeat the test with a new test strip.
Defective meter.
Please contact customer services.
Apply sample only when flashing “ ”
appears on the display.
3. If the control solution testing result is out of range.
POSSIBLE CAUSE
WHAT TO DO
Error in performing the test.
Read instructions thoroughly and
repeat the test again.
Control solution vial was poorly
shaken.
Shake the control solution vigorously and repeat the test again.
Expired or contaminated control
solution.
Check the expiration date of the
control solution.
Control solution that is too warm or
too cold.
Control solution, meter, and test
strips should be at room temperature (68°F-77°F/20°C-25°C) before
testing.
Defective test strip.
Repeat the test with a new test strip.
Meter malfunction.
Please contact customer services.
41
DETAILED INFORMATION
Reference Values
Blood glucose monitoring plays an important role in diabetes control.
A long-term study showed that maintaining blood glucose levels
close to normal can reduce the risk of diabetes complications by up
to 60%*1. The results provided by this system can help you and your
healthcare professional monitor and adjust your treatment plan to
gain better control of your diabetes.
Time of day
Normal plasma glucose range for people
without diabetes (mg/dL)
Fasting and before meal
Less than 100 mg/dL (5.6 mmol/L)
2 hours after meals
Less than 140 mg/dL (7.8 mmol/L)
Source: American Diabetes Association (2008). Clinical Practice Recommendations. Diabetes Care, 31 (Supplement 1): S1-108.
Please work with your doctor to determine a target range that
works best for you.
*1: American Diabetes Association position statement on the Diabetes Control and Complications Trial (1993).
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Comparing Meter and Laboratory Results
The meter provides you with whole blood equivalent results. The
result you obtain from your meter may differ somewhat from your
laboratory result due to normal variation. Meter results can be affected by factors and conditions that do not affect laboratory results
in the same way. To make an accurate comparison between meter
and laboratory results, follow the guidelines below.
Before going to the lab:
Perform a control solution test to make sure that the meter is working properly.
Fast for at least eight hours before doing comparison tests, if possible.
Take your meter with you to the lab.
While staying at the lab:
Make sure that the samples for both tests test are taken and tested
within 15 minutes of each other.
Wash your hands before obtaining a blood sample.
Never use your meter with blood that has been collected in a graytop test tube.
Use fresh capillary blood only.
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You may still have a variation from the result because blood glucose
levels can change significantly over short periods of time, especially if you have recently eaten , exercised, taken medication, or
experienced stress*2. In addition, if you have eaten recently, the
blood glucose level from a finger prick can be up to 70 mg/dL (3.9
mmol/L) higher than blood drawn from a vein (venous sample)
used for a lab test*3. Therefore, it is best to fast for eight hours
before doing comparison tests. Factors such as the amount of red
blood cells in the blood (a high or low hematocrit) or the loss of
body fluid (dehydration) may also cause a meter result to be different from a laboratory result.
References
*2: Surwit, R.S., and Feinglos, M.N.: Diabetes Forecast (1988), April, 49-51.
*3: Sacks, D.B.: “Carbohydrates. “ Burtis, C.A., and Ashwood, E.R.( ed.), Tietz Textbook of
Clinical Chemistry. Philadelphia: W.B. Saunders Company (1994), 959.
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SPECIFICATIONS
Model No.: TD-4267
Dimension & Weight: 90mm(L) x 55mm (W) x 18mm (H),
49g (without battery)
Power Source: one CR2032 lithium battery
Display: LCD
Memory: 450 measurement results with respective date and time
External output: mini USB cable
Auto electrode inserting detection
Auto sample loading detection
Auto reaction time count-down
Auto turn-off after 3 minutes without action
Temperature Warning
Operating Condition: 10°C~40°C, below 85% R.H. (non-condensing)
Storage/Transportation Condition: -20°C~60°C, below 95% R.H.
Measurement Units: mg/dL
Measurement Range: 20~600mg/dL (1.1~33.3 mmol/L)
This device has been tested to meet the electrical and safety requirements of:
IEC/EN 61010-1, IEC/EN 61010-2-101, EN 61326-1, IEC/EN 61326-2-6
Distributed by:
Simple Diagnostics
P.O. Box 128
Williston Park, NY 11596
U.S.A.
24-Hour Toll Free: 1-877-DIABETK (1-877-342-2385)
www.SimpleDiagnostics.com
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NOTE
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