SkyMed TD-4227 Manuel utilisateur
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 reects 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 signicant inuence 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 signicantly 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
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