’s r e n al w O anu M 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.
Blood Glucose Monitoring System OWNER'S MANUAL Dec. 2009 Version 1.
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.
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.
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
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.
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.
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.
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.
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.
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 .
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
NOTE 46
