Advocate Meters TD-4223 A/B User Manual

Dear Advocate™ TD-4223 A/B System Owner:
You have chosen one of the best blood glucose monitoring systems. 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 speaking function (with a talking symbol on the meter), 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 internal established code. Not only does it simplify the glucose test, it also provides you and your doctor with more precise and accurate test results. 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.
PLEASE NOTE
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. These recommendations apply to all blood glucose
monitoring systems and are supported by the Diabetes Educator
Section of the Canadian Diabetes Association.
IMPORTANT SAFETY INSTRUCTIONS 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, handicapped persons or invalids.
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. Do not use the device near a mobile phone or microwave
oven, or it may cause inaccurate results.
KEEP THESE INSTRUCTIONS
1
TABLE OF CONTENTS
IMPORTANT SAFETY INSTRUCTIONS 1
IMPORTANT INFORMATION
ABOUT ATERNATIVE SITE TESTING (AST)
INTRODUCTION OF THE SYSTEM 8
Intended Use 8
Principle of Measurement 8
Contents of the System
Appearance and Key Function of the Meter
Meter Display Segments
Speaking Function 12
Appearance of the Test Strip 13
PRERPARATION BEFORE USE 14
Battery Replacement 14
Setting the Meter and Deleting the Memory
BEFORE TESTING
Checking the Display
Calibration
Checking with Advocate™ Control Solution
Important Control Solution Information
Doing a Control Solution Test 26
TESTING YOUR BLOOD
Testing Procedure 30
Expected Test Results 36
10
11
16
21
21
21
23
25
29
4
6
9
2
COMPARING METER AND LABORATORY RESULTS 37
USING THE METER MEMORY 39
Viewing Results on the Meter
Viewing Results on a Personal Computer
39
43
CARING FOR YOUR METER AND TEST STRIPS 45
Cleaning 45
Storage 45
PROBLEM-SOLVING GUIDE 48
Result Indicator 49
Error Message 50
Problem in Operation 51
SPECIFICATIONS
SYMBOL INFORMATION
WARRANTY/CUSTOMER CARE
53
54
55
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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 60 mg/dL* (3.3 mmol/L) mean low
blood glucose (hypoglycemia). Test results greater
240 mg/dL* (
than
2
13.3 mmol/L) mean high blood
1
glucose (hyperglycemia). If you get results below 60 mg/dL or above
240 mg/dL, and do not have symptoms, first repeat the test. If you have symptoms or continue to get results that fall below 60 mg/dL or above 40 mg/dL, 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.
A red blood cell count (hematocrit) that is very high (above 60%) or very low (below 20%) can cause false results.
4
The following WILL NOT affect results:
Elevated blood triglyceride, reducing substances
such as uric acid and ascorbic acid when occurring in expected blood concentration, or acetaminophen, dopa, methyldopa, L-dopa and tolbutamide occurring in expected blood concentrations.
feet
This system may be used at altitudes up to 10,742
(3,275 m) without an effect on test results.
*1. Kahn, R., and Weir, G,: Joslin’s 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.
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ABOUT ALTERNATIVE SITE TESTING (AST)
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 fingertips to check their blood glucose levels. This system provides you to test on the pam, the forearm, the upper arm, the calf, or the l thigh with the equivalent results to fingertip 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 were not so condensed, you will not feel as much pain as at the
fingertip.
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. Therefore when testing blood glucose during or immedi­ately after meal, physical exercise, or any other events,
take blood samples from your finger only.
6
We strongly recommend you do AST ONLY in the fol - lowing 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.
Do NOT use AST if:
You think your blood glucose is low. If you are awareness of being hypoglycemia. Your AST results do not match the way you feel. You are testing for hyperglycemia. Your routine glucose results are often fluctuating. If you are pregnant.
How to increase the accuracy?
Stimulating blood perfusion by rubbing the puncture site prior to blood extraction has a significant influence on the glucose value obtained. Blood from the site without rubbing exhibits a measurably different glucose concen ­tration than blood from the finger. When the puncture site was rubbed prior to blood extraction, the difference was significantly reduced.
If you would like to obtain blood from sites other than the finger, replace the lancet device cap with the clear cap. The clear cap for AST is an optional accessory, please contact your local customer service.
NOTE: We suggest that before getting a drop of blood rub
the pucture site about 20 seconds before penetration.
7
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. The system is intended for use in the home and in clinical settings. 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.
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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 Advocate
test strips and Advocate control solution with your
Advocate TD-4223 A/B Monitor.
TM
Your system includes:
1. A Meter
2. Owner’s manual
3. Sporty carrying case
4. Quick reference guide
5. Warranty Card
TM
TM
TD-4223
TD-4
CODE
CODE
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.
Advocate Glucose Meter
W
ARRANTY CARD
9
Appearance and Key Function of the Meter
TEST SLOT
Is where you insert the test strip. The meter will turn on automatically after insertion.
LCD DISPLAY
Guides you though the test using symbols and simple messages.
CODE BUTTOM
Located in front of the meter, is for code selection.
TD-4223
CODE
SET BUTTON
(in the back) located in the battery com­partmen, is used to set up the meter.
MAIN BUTTOM
Located in front of the meter with “ ” on it, is used to turn on the meter, enter the memory mode and control steps of setting.
m
TALKING SYMBOL
Indicate that the meter contains speaking function.
10
DATA PORT
Located at the side, is for cable connection.
Meter Display Segments
TEST STRIP SYM­BOL
Appears when the meter is turned on.
BLOOD DRO P SYMBOL
Flashes when it is ready to apply the sample.
CODE
Appears with the code number cur ­rently in use.
TEMPERATURE SYMBOL
Appears when ambi ­ent temperature is outside operating temperature .
CTL SYMBOL
Appears when doing a control test and indicates that the result will not be stored in the memory .
DAY AVERAGE
Indicates that the displayed test result is an average .
MEMOR Y SYMBOL
Appears when you review the memor y.
TIME
DATE
VOICE SYMBOL
Indicates speaking
function is on/o ff.
TEST RESU LT AREA
Displays glucose results. A decimal point appears when the measurement unit is mmol/L .
LOW BA TTER Y SYMBOL
Appears when the bat-
tery power is lo w.
FACE SYMBOL LOW/HIGH SYM ­BOL
Both are result indica­tors. They appear together with the test result which exceeds the reference range .
MEASUREMENT UNI T
Appears with the test result either in mmol/L or in mg/dL.
KET ONE W ARNING
Appears when the test result is equal or higher than 240mg/dL (13.3mmol/ L).
SMILE SYMBOL
Appears when the test result is within refer­ence range.
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Speaking Function
When a 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”. Those messages can also be found in the end section of this manual “SUMMARY OF OPERATION”.
WHEN
does the meter speak?
When meter is turned on
When room temperature is detected.
When room temperature is
outside operating range.
After inserting test strip and completing code selection.
When the meter is ready to test. ( “ ” symbol appears on display)
When the test is completed. (The result appears on display)
When the test result is outside measurement range, which is 20-600 mg/dL.
When turn off the meter.
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WHAT
does the meter speak?
A welcome music plays. Thank you for using this product. Please relax during measurement .
The room temperature is (number) degree Celsius/ Fahrenheit.
Room temperature out of range, unable to measure.
The code number is (number)
Please apply blood into the strip.
The blood glucose is (number) Milligram Per Deciliter/ Millimole Per Liter.
The blood glucose out of range, unable to measure.
An ending music plays.
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 firmly until it will go no further.
Test Strip Handle
Hold this part to insert the test strip into the slot.
Confirmation Window
This is where you confirm 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 sucked in automatically.
Please see pages 29-35, “Testing Your Blood”, for com­plete instructions.
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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 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 (previ -
ous 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 battery if you are not going to use the device for an extended
period (i.e., months or more)
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To replace the batteries, 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 batteries and replace with two
1.5V AAA size alkaline batteries. Make sure that the positive “+” side is facing up.
3. Close the battery cover. If the batteries are inserted correctly, you will hear a "beep".
1
WARNING
As with all small batteries, the batteries should be kept away from
small children who still put things in their mouths. If they are swal -
lowed, promptly see a doctor for help.
2
3
15
Setting the Meter and Deleting the Memory
Your meter comes with the time, date, unit of measurement and unit of temperature preset. However if you replace the batteries, you may need to reset the setting 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 setting up the meter.
STEP 1. Set the Year
The year will appear first, with the year setting flashing. 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 flashes.
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