AG50E OWNER’S MANUAL BLOOD GLUCOSE MONITORING SYSTEM
AG50E BLOOD GLUCOSE MONITORING SYSTEM OWNER’S MANUAL 311-4227000-005 Ver 1.0 , 2010.
Dear AccurateCheck AG50E 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 feature of this system is its no code. Not only 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).
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 higher or lower than usual, follow the treatment advice of your healthcare professional.
TABLE OF CONTENTS IMPORTANT INFORMATION 05 ABOUT ALTERNATIVE SITE TESTING(AST) 08 GETTING STARTED 10 Contents of the System 10 Appearance and Key Function of the Meter 11 Meter Display Segments 12 Test Strip 13 Important Test Strip Information 14 BEFORE TESTING 15 Display Self-Checks 15 About the Control Solution 15 Important Control Solution Test Information 16 TESTING YOUR BLOOD SUGAR 17 Getting a Drop of Blood 17 Step-by-Step Test Procedure 20 USING THE METER MEMORY 22 VIE
SETTING THE METER AND DELETING THE MEMORY 27 TAKING CARE OF YOUR METER 31 Maintenance 31 Battery Replacement 31 PROBLEM-SOLVING GUIDE 33 Result indicator 34 Error Message 35 Operational problem 36 SPECIFICATIONS Performance Characteristics 38 38 EXPECTED TEST RESULTS 39 SYMBOLS INFORMATION 40 SUMMARY OF OPERATION 41 7
ABOUT ALTERNATIVE SITE TESTING (AST) Important: AST results serve as references only. Please consult your healthcare professional before you begin 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 your forearm, upper arm, calf, or thigh with the equivalent results to fingertip testing.
We strongly recommend you do AST 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. Do NOT use AST if: you think your blood glucose is low. you are unawareness of hypoglycemia. your AST results do not match the way you feel. you are testing for hyperglycemia. your routine glucose results are often fluctuating.
GETTING STARTED Contents of the System The system consists of three main products: a 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 same brand-name test strips and a control solution with the blood glucose meter.
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 SCREEN guides you through the test using symbols and simple messages. SET BUTTON (in the back) located in the battery compartment, is used to set up the meter. MAIN BUTTON located in front of the meter with “M” on it, is used to turn on the meter, enter the memory mode and navigate through settings. DATA PORT located at the side, is for cable connection.
Meter Display Segments TEST STRIP SYMBOL Appears when the meter is turned on. TEST RESULT AREA Displays glucose results. A decimal point appears when the measurement unit is mmol/L. BLOOD DROP SYMBOL Flashes when it is ready to apply the sample. LOW BATTERY SYMBOL Appears when the battery power is low. FACE SYMBOL LOW/HIGH SYMBOL TEMPERTURE SYMBOL Appears when ambient temperature is outside operating temperature.
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.
Important Test Strip Information Store test strip packages in a cool, dry place at 4-40˚C (39.2-104˚F). Keep away from direct sunlight and heat. Do not refrigerate. Store your test strips in their original vial only. Do not transfer them to a new bottle or any other container. After removing a test strip from the vial, immediately replace the vial cap and close it tightly.
BEFORE TESTING Display Self-Checks Each time you insert a test strip, the meter displays “CH” and “ ”. This tells you that the system is performing several self-checks. About the Control Solutions Our control solutions contain a known amount of glucose that reacts with test strips.
Whenever you suspect that the meter or test strips are not working properly. When your blood glucose test results are not consistent with how you feel, or when you think your results are inaccurate. When your test strips are exposed to extreme environmental conditions (See Important Test Strip Information section of this manual). When you want to practice running the test. If you drop the meter. Important Control Solution Test Information Use only our control solutions.
TESTING YOUR BLOOD SUGAR Getting a Drop of Blood STEP 1 Insert a Lancet in the Adjustable Lancing Device Pull off the cap of the lancing device. Insert a lancet into the lancet holder and push down firmly until it is fully secured. Twist the protective disk off the lancet. WARNING ! To reduce the chance of infection: Never share a lancet or the Lancing Device with anyone. Always use a new, sterile lancet. Lancets are for single use only.
When obtain blood from sites other than the fingertip A clear cap, together with the kit, makes you easier to get a drop of blood for AST. When you want to obtain blood from sites except the finger, replace the clear cap instead of the lancing device cap. Screw the clear cap until it is snug but not too tight, and then go to step 2. STEP2 Cock the Lancing Device Pull the cocking control back until it clicks. You will see a color change inside the release button when it is ready.
WARNING ! The system requires a very small blood drop to perform a test. You can obtain it from a fingertip. Choose a different spot each time you test. Repeated punctures at the same spot may cause soreness and calluses. Before you decide to do palm testing, please consult your health professional first. STEP 5 Gently Massage the area Do not smear the blood sample. To obtain best accurate results, it is recommended that the first drop of blood should be discarded with a clean tissue paper or cotton.
Step-by-Step Test Procedure STEP 1 Insert the Test Strip Fully insert test strip face up with contact bars end first, into the test slot. The meter will turn on automatically and display the following in sequence: “CH” and “ ” room temperature flashing “ ”. STEP 2 Apply Sample Obtain a drop of blood using the adjustable Lancing Device. The blood sample must be at least 0.7 microliter in volume ( actual size) or you may get an inaccurate test result.
STEP 3 Obtain an Accurate Result in 7 Seconds Your blood glucose test result will appear after the meter counts down to 0. This blood glucose result will automatically be stored in the meter memory. Turn the meter off by removing the test strip. Discard the used test strip carefully to avoid contamination. NOTE ! If you do not apply a blood sample within 1 minutes, the meter will automatically turn off. You must remove the test strip and insert it back again to restart the test procedure.
USING THE METER MEMORY Your meter stores the 450 most recent blood glucose test results along with their respective dates and times in its memory. It also provides you with 7-, 14-, 21-, 28-, 60- and 90-day averages of your blood glucose test results. You can review these averages test results in memory through these easy steps. STEP 1 Enter the Memory Mode With the meter turned off, press the M button twice. The 7-day average will appear, indicating that you are in the memory mode.
The 14- day average is calculated from the blood glucose results obtained during the last 14 days. It, too, indicates how many blood glucose tests have been performed, e.g., 28 (28 tests in the last 14 days). The same follows for the 21-, 28-, 60- and 90- day average. STEP 2 Recall Test Results After the 90- day average, the most recent test result and its date and time will be displayed. Press the M button once and the next most recent test result will appear.
VIEWING RESULTS ON A PERSONAL COMPUTER Results in memory can be transmitted to a personal computer. Health Care System Software and an interface cable are required before installation. The software can be downloaded from the home page of TaiDoc Technology Corp. The interface cable is an optional accessory. To learn more about Health Care System Software or to obtain an Interface Cable separately, please contact your local customer service.
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. (See test strip package insert for typical accuracy and precision data, and for important information on Limitations.
You may still have a variation from the result because blood glucose levels can vary significantly over short periods of time, especially if you have recently eaten, exercised, taken medication, or experienced stress1. In addition, if you have eaten recently, the blood glucose level from a finger prick can be up to 70mg/dL (3.9 mmol/L) higher than blood drawn from a vein (venous sample ) used for a lab test². Therefore, it is best to fast for eight hours before doing comparison tests.
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 need to change the time, or if you replace the batteries, you may need to enter the setting mode and reset. Please set the time, date, unit of measurement and temperature or delete memory according to the follow-up steps. To set the time, you must first enter the setting mode. Start with the meter off.
STEP 3 Set the Date Press and release the M button until the correct date appears. To move faster, hold the M button down. With the correct day on the display, press the set button and the time will appear on the display with the hour segment flashing. STEP 4 Set the Hour Press and release the M button to advance one hour. To move faster, hold the M button down. With the correct hour on the display , press the set button and the minutes setting will start flashing.
NOTE ! Day averages are calculated from results obtained during the 7, 14, 21, 28, 60 and 90 days 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. Your meter can display test results in millimoles per litre (mmol/L) or milligrams per deciliter (mg/dL). The mmol/L unit is standard in Canada. The mg/dL unit is standard in the United States.
Set-up is all completed. Press the set button to turn off the meter. “OFF” will be displayed before shut down.
TAKING CARE OF YOUR METER Maintenance Your meter does not require special maintenance. As no blood or control solution comes in contact with the meter, there is no special cleaning required. Take care to avoid getting dirt, dust, blood, control solution or water inside the meter through the test port or data port. Store the meter in its carrying bag after each use. A cloth dampened with water and mild detergent can be used to wipe down the outside of the meter . You meter is a precision instrument.
To replace the battery, make sure that the meter is turned off. STEP1 Press the buckle on battery cover and lift up to remove cover. STEP2 Remove the old battery and replace with two 1.5V AAA alkaline batteries. STEP3 Close the battery cover. NOTE ! Replacing the batteries does not affect the meter’s memory ( previous test results stored in memory ). However, the time, date and units settings may need to be updated. As with all small batteries, the batteries should be kept away from small children.
PROBLEM-SOLVING GUIDE The following is a summary of various display messages and symbols. These messages help to identify certain problems but do not always 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 under action. If you follow the action recommended but the problem still persists, please call the dealer for service.
Result Indicator Special symbols and messages appear together with your test result. Message What it means appears when your result is at reference range from 70 to 119 mg/dL (3.9 and 6.6 mmol/L). appears when your result is between 20 and 69 mg/dL (1.1 and 3.8 mmol/L). It indicates that the result is below reference range. appears when your result is below measurement limit, which is less than 20 mg/dL (1.1 mmol/L). “Lo” or “ ” symbol indicates hypoglycemia (low blood glucose.
Error Message Message What it means Action Appear when the battery can not provide enough power for a test. Replace the battery immediately. Appear when inserting a used test strip. Test with a new test strip. Appear when environmental temperature is below system operation System operation range is range. 10~40°C (50~104°F).Repeat the test after the meter Appear when environmental tem- and test strip have reached the above temperature. perature is above system operation range.
Operational Problem Situation: The meter does not display a message after inserting a test strip. PROBABLE CAUSE Battery exhausted. WHAT TO DO Replace the battery. Battery incorrectly installed Check that the battery is coror absent. rectly installed. Test strip inserted upside- Insert the test strip correctly down or incompletely. with the contact bars end first and facing up. Defective meter. Please call the dealer for service. Situation: The test does not start after applying the sample.
Situation: If the control solution test result is out of range. PROBABLE CAUSE WHAT TO DO Error in performing the test. Read the instruction thoroughly and repeat the test again. Control solution poorly shak- Shake the control solution en. vigorously and repeat the test again. Expired or contaminated Check the expiration date control solution. or the discarded date of the control solution. Control solution that is too Control solution, moniwarm or too cold.
SPECIFICATIONS Model no.:TD-4202 Dimension&Weight: 96mm(L)x45mm(W)x23mm(H), 76.15g Power source: two 1.5V AAA alkaline batteries Display: LCD Memory: 450 measurement results with respective dates and times Auto electrode inserting detection Auto sample loading detection Auto reaction time count-down Auto shutdown after 3 minutes of idleness Temperature warning Operating condition: 10°C~40°C, below 85% R.H. (noncondensing) Meter Storage/Transportation condition: -20°C to 60°C, below 95%R.H.
EXPECTED TEST RESULTS 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.
SYMBOLS INFORMATION Symbol Referent For in vitro diagnostic use only Do not reuse Read instructions before use Keep away from sunlight Keep dry Temperature limitation Use by Batch code Manufacturer Serial number Caution, consult accompanying documents Authorized representative in the European Community CE mark Do not use if package is damaged 3M Use within 3 months after opening Sterilized using irradiation 40
SUMMARY OF OPERATION This summary is intended for quick reference only. It is not a substitute for the owner’s manual. Please read the entire manual before you begin testing. STEP 1 Insert Test Strip The meter will automatically turn on and display room temperature followed by the flashing “ ”. STEP 2 Apply Sample Touch and hold the drop of blood to the absorbent hole of test strip until confirmation window is completely filled. STEP3.
Biocare Corporation 4F, NO.12, Lane 5, Sec 2, Nanshan Rd., Lujhu Township, Taoyuan County 33852, Taiwan TEL: +886 3 261 6678 FAX: +886 3 261 6679 Web site: www.biocare.com.tw MedNet GmbH Borkstrasse 10, 48163 Muenster – Germany Tel:+49 251 322660 Fax:+49 251 32 26622 For self-testing.