SkyMed TD-4227 User manual

Owner’s Manual
Ver. 1 12/2013
311-4223500-XXX
Blood Glucose
Monitoring System

Dear SureTest System Owner:
This manual contains important information you must know about the system.
Please read it thoroughly and carefully.
The greatest feature of this system is its Bilingual Speaking Function , which
is an acoustic aid for users especially with visual disability. Please note that this
function is optional. If the meter does not have , it will not provide speaking
function.
Another unique feature is its SureTest function which means there is no need to
calibrate your meter, and allows you to easily monitor your blood glucose at home.
The system is intended for use outside the body (in vitro diagnostic use). It should
be used only for testing glucose (sugar) and only with fresh capillary whole blood
samples.The system is intended for use in the home and in clinical settings. It
should not be used for the diagnosis of diabetes or the testing of newborns.
An audio version of the owner’s manual is available on the enclosed CD or
on our website at or by calling one of our friendly
representatives at
2

3
IMPORTANT SAFETY INSTRUCTIONS
PLEASE READ THIS BEFORE USING
The following basic safety precautions should always be taken.
1. Close supervision is necessary when the device is used by, on, or near children,
or handicapped persons.
2. Use the device only for the intended use described in this manual.
3. Do not use strips and control solutions which are not supplied by
the manufacturer.
4. Do not use the device if it is not working properly, or if it has suffered any
damage.
5. Before using any product to test your blood glucose, read all instructions
thoroughly and practice the test. Do all quality control checks as directed and
consult with a diabetes healthcare professional.
KEEP THESE INSTRUCTIONS

TABLE OF CONTENTS
IMPORTANT SAFETY INSTRUCTIONS 03
IMPORTANT INFORMATION 06
ABOUT ATERNATIVE SITE TESTING (AST) 07
INTRODUCTION OF THE SYSTEM 09
Intended Use 09
Principle of Measurement 09
Contents of the System 10
Appearance and Key Function of the Meter 11
Meter Display Segments 12
Speaking Function 13
Appearance of the Test Strip 14
PREPARATION BEFORE USE 15
Battery Replacement 16
Setting the Meter and Deleting the Memory 17
BEFORE TESTING 22
Checking with SureTest Control Solutions 22
Important Control Solution Information 23
Performing a Control Solution Test 24
TESTING YOUR BLOOD 27
Testing Procedure 28
Expected Test Results 34
COMPARING METER AND LABORATORY RESULTS 35
USING THE METER MEMORY 37
Viewing Results on the Meter 37
Viewing Results on a Personal Computer 41
4

CARING FOR YOUR METER AND TEST STRIPS 43
Cleaning 43
Storage 43
PROBLEM-SOLVING GUIDE 46
Result Indicator 47
Error Message 48
Problem in Operation 49
SPECIFICATIONS 51
WARRANTY/CUSTOMER CARE 52
5

IMPORTANT INFORMATION
• Severe dehydration and excessive water loss may cause false low results. If you
believe you are suffering from severe dehydration, consult a healthcare
professional immediately.
• Test results below 3.3 mmol/L*1mean low blood glucose (hypoglycemia).Test
results greater than 13.3 mmol/L*2mean high blood glucose (hyperglycemia).
If you get results below 3.3 mmol/L or above 13.3 mmol/L, and do not have
symptoms, rst repeat the test. If you have symptoms or continue to get results
that fall below 3.3 mmol/L or above 13.3 mmol/L, follow the treatment advice
of your healthcare professional.
• Apply only capillary whole blood sample to the absorbent hole. Applying other
substances to the absorbent hole will cause inaccurate results.
• If you are experiencing symptoms that are not consistent with your blood
glucose test results and you have followed all instructions described in this
owner’s manual, call your healthcare professional.
• Inaccurate results may occur in severely hypotensive individuals or patients
in shock. Inaccurate low results may occur for individuals experiencing
a hyperglycemic-hyperosmolar state, with or without ketosis. Critically ill
patients should not be tested with blood glucose meters.
• Please refer to the test strip package insert for additional important information.
*1:Kahn, R., and Weir, G.: Joslinís Diabetes Mellitus, 13th ed. Philadelphia: Lea and Febiger (1994), 489.
*2:Krall, L.P., and Beaser, R.S.: Joslin Diabetes Manual. Philadelphia: Lea and Febiger (1989), 261-263.
6

ABOUT ALTERNATIVE SITE TESTING (AST)
7
When to use AST?
Food, medication, illness, stress and exercise can affect blood glucose levels.
Capillary blood at ngertip reects these changes faster than capillary blood at
other sites. Alternative site results may be different from ngertip results when
glucose levels are changing rapidly (e.g., after a meal, after taking insulin, or during
or after exercise).Therefore when testing blood glucose during or immediately
after a meal, physical exercise, or after taking insulin, take blood sample from
your nger only.
We strongly recommend you do AST ONLY in the following intervals:
• 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.
Important: There are limitations for doing AST.
Please consult your healthcare professional before
you do AST.
What is AST?
Alternative site testing (AST) means that people
use parts of the body other than ngertips 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
the equivalent results to ngertip testing.
What’s 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 concentrated,
you will not feel as much pain as at the ngertip.

Do NOT use AST if:
• You think your blood glucose is low.
• You are unable to notice symptoms of hypoglycemia.
• Your AST results do not match the way you feel.
• You are testing for hyperglycemia.
• Your routine glucose results are often uctuating.
• You are or may be pregnant.
How to increase the accuracy?
Stimulating blood perfusion by rubbing the puncture site prior to blood
extraction has a signicant inuence on the glucose value obtained. Blood from
the site without rubbing exhibits a measurably different glucose concentration
than blood from the nger. When the puncture site was rubbed prior to blood
extraction, the difference was signicantly reduced.
NOTE: We suggest that you rub the puncture site for about 20 seconds before
taking your sample.
8

INTRODUCTION OF THE SYSTEM
Intended Use
The system is intended for use outside the body (in vitro diagnostic use). It should
be used only for testing glucose (sugar) and only with fresh capillary whole blood
samples taken from the nger and the alternative sites including the palm, the
forearm, the upper arm, the calf and the thigh. The system is intended for home
use. It should not be used for the diagnosis of diabetes or
for the testing of newborns.
Principle of Measurement
The test is based on the measurement of electrical current generated by
the reaction of glucose with the reagent of the strip. The meter measures the
current and displays the corresponding blood glucose level. The strength of the
current produced by the reaction depends on the amount of glucose in the blood
sample.
9

Contents of the System
The system should be used with three main products: the blood glucose meter,
test strips, and a control solution.These products have been designed, tested, and
proven to work together as a system to produce accurate blood glucose test
results. Use only the SureTest test strips and SureTest or SureTest control solution
with your SureTest meter.
Your system includes:
1. A meter 2. Your rst time using guide 3. Test strips (sold separately)
4. Lancing Device with clear cap 5. 10 Sterile lancets
6. Control solution (Optional) 7. Owner’s manual 8. Sporty carrying case
9. Warranty card
PLEASE NOTE
• Check your system to be sure that it is unopened prior to use and that it
contains all parts listed above. If either of these conditions occurred, please
return your system to the place of purchase.
• Please note that strips and control solutions are optional.Those are not included
in the standard kit. Please ask your local agent or call toll free
for help.
10
first time user guide

Appearance and Key Function of the Meter
TEST SLOT
The test slot is where you
insert the test strip for test-
ing. The meter will turn on
automatically when you insert
a test strip.
DISPLAY
Your test results are
displayed here. The large,
easy-to-read display guides
you through the test using
symbols and simple mes-
sages.
SET BUTTON
(in the back)
Set the date, time and
unit, located in the
battery
compartment.
MAIN BUTTON
The main button in front of
the meter is used to set up
the meter, enter the memory
mode, change the value of
“date time”, unit setting,
memory deletion and turning
the meter on and off.
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TALKING SYMBOL
Indicates that the meter
contains speaking function.
DATA PORT
Located at the side, is for cable
connection to the computer.

Meter Display Segments
Test Result Area
Test results are displayed here.
Blood Drop Symbol
This symbol tells you when
to apply the sample.
Test Strip Symbol
Appears when the meter is on.
Date
Time
Battery Symbol
Appears when the battery is low.
Memory Symbol
Appears when you
review the memory.
Temperature Symbol
Appears with ambient
temperature after inserting
a test strip.
CTL Symbol
Appears when performing
a control solution test and
indicates that the result will
not be stored in the memory.
Measurement unit
Appears with the test result
in mmol/L.
12
Voice Symbol
Indicates speaking function is
on/off.
Day Average
Indicates that the displayed
test result is an average.
Ketone Warning
Appears when the test
result is equal or higher than
13.3mmoI/L.

Speaking Function
When the talking symbol is on the meter, it means that the meter provides
speaking function. It “speaks” step by step and leads you through a blood glucose
test.The following table tells you when and what the meter “speaks”.
“The blood glucose is out of range,
thus unable to measure.”
When the test result is outside
measurement range, which is 1.1
to 33.3 mmol/L.
“Your blood glucose is (number)
Millimole per Liter”
When the test is completed.
(The result appears on display).
When the meter is ready to test.
( “ ”symbol appears on display) “Please apply blood into the strip.”
“Room temperature is out of range,
thus unable to measure.”
When room temperature is outside
operating range.
When room temperature is detected. “The room temperature is (number)
degree Celsius/ Fahrenheit.”
Welcome music plays.
“Thank you for using this product.
Please relax during measurement.”
When meter is turned on.
13
WHEN
does the meter say?
WHAT
does the meter speak?

Appearance of the Test Strip
Your system measures the amount of sugar (glucose) in whole blood. Blood
is applied to the absorbent hole of the test strip and is automatically drawn into
the reaction cell where the reaction takes place.
The test strip consists of the following parts:
Contact Bars
Insert this end of the test strip into the meter.
Push it in rmly until it will go no further.
Test Strip Handle
Hold this part to insert the test strip into the slot.
Conrmation Window
This is where you conrm if enough blood
has been applied to the absorbent hole of the strip.
Absorbent Hole
Apply a drop of blood here.
The blood will be drawn automatically.
See pages 27~33,Testing Your Blood, for complete instructions.
14

15
PREPARATION BEFORE USE
Battery Replacement
Your meter comes with two 1.5V AAA size alkaline batteries.
The meter will alert you when the power is getting low by displaying two different
messages:
1.The symbol appears together with other
display messages: the meter is functional
and the result remains accurate, but it is
time to change the batteries.
2.The symbol appears with the ashing
E-b symbol and “low”: the batteries can not
provide enough power to do a test. You
must change the batteries immediately.
PLEASE NOTE
• Replacing the batteries does not affect the meter’s memory (previous test results
stored in memory). However, the time and date settings may need to be updated.
• Batteries might leak chemicals if not used 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).

16
To replace the batteries, make sure that the meter
is turned off.
1. Press the buckle on battery cover and lift up to remove cover.
2. Remove the old batteries and replace with two new 1.5V AAA size alkaline
batteries.
3. Close the battery cover. If the batteries are inserted correctly, you will hear
a “beep”.
WARNING
1. 2. 3.
As with all small batteries, the batteries should be kept away from small children
who still put things in their mouths. If they are swallowed, promptly see a doctor
for help.

17
Setting the Meter and Deleting the Memory
Year, month, date, time, unit of temperature, memory deletion, speaking volume and
language selection preset. However if you replace the batteries, you may need to
reset the settings of the meter.
Start with the meter off. Then
press the Set button located
in the battery compartment.
The meter is now in the setting
mode. You can start to set up
the meter.
STEP 1 Set the Year.
The year will appear rst, with the year
segment ashing. Press and release the
button to advance one year. To
move faster, keep pressing the
button until the desired number
appears. With the correct year on
the display, press the Set button and
then the month segment ashes.

18
STEP 2 Set the Month
Press and release the button until the
correct month appears. To move faster,
hold the button down. With the correct
month on the display, press the Set button
and then the date segment ashes.
STEP 3 Set the Date
Press and release the button until the
correct day appears. To move faster, hold
the button down.With the correct day
on the display, press the Set button and then
the hour segment ashes.
STEP 4 Set the Hour
Press and release the button to advance
one hour.To move faster, hold the
button down. With the correct hour on the
display, press the Set button and then the
minute segment ashes.

19
STEP 5 Set the Minutes.
Press and release the button to advance
one minute. To move faster, hold the
button down. With the correct minute on
the display, press the Set button and then the
current unit of temperature starts ashing.

20
STEP 6 Delete the Memory
When “dEL” and blinking “ ” symbol is displayed, if you do not want to delete memory,
press the Set button again to skip this step. If you would like to delete ALL memory, press
button, both “dEL” and “ ” will ash. Press the button again to delete ALL
memory.“---”and “ ” are displayed on the meter, following “ ” means that all data
stored are deleted. The memory of this meter is empty now.
PLEASE NOTE
• The above settings can ONLY be changed in the setting mode.
Therefore, when you perform a glucose testing, those parameters are not possible to be
changed.
• Your meter displays 7-, 14-, 21-, 28-, 60- and 90-day averages which you can access from the
meter memory.These averages are calculated from results obtained during the 7-, 14-, 21-,
28-, 60- and 90-day preceding the current date and time settings.When the date and time are
changed, the 7-, 14-, 21-, 28-, 60- and 90-day averages may change.
• While the meter is in the setting mode, if no button is pressed for 3 minutes, the meter will
turn off automatically.
The memory of this meter is now empty.