Blood Glucose Monitoring System OWNER'S MANUAL Version 1.
Dear UltraTRAK Ultimate System Owner: Thank you for purchasing the UltraTRAK Ultimate 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 the device only for the intended use described in this manual. 2. Do not use accessories which are not supplied by the manufacturer. 3. Do NOT use the device if it is not working properly 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 on newborns or infants. 6. This device does NOT serve as a cure for any symptoms or diseases.
TABLE OF CONTENTS IMPORTANT SAFETY PRECAUTIONS 3 BEFORE YOU BEGIN 6 Important Information 6 Intended Use 7 Test Principle 7 Contents of System 8 Meter Overview 9 Display Screen 10 Test Strip 11 Setting the Meter 12 THE FOUR MEASURING MODES 15 BEFORE TESTING 16 Control Solution Testing 16 Performing a Control Solution Test 16 GETTING A BLOOD SAMPLE 19 Overview of the Lancing Device 19 Setting up the Lancing Device 19 Preparing the Puncture Site 21 Performing a Blood Gluc
Battery 29 Caring for Your Meter 31 Caring for Your Test Strips 31 Important Control Solution Information 32 SYSTEM TROUBLESHOOTING 33 Result Readings 33 Error Message 34 Troubleshooting 35 DETAILED INFORMATION 36 Reference Values 36 Comparing Meter and Laboratory Results 37 SPECIFICATIONS 39
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 any 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 monitor 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. It should not be used for the diagnosis of diabetes, or testing on newborns.
Contents of System Your new UltraTRAK Ultimate system kit includes: Meter Daily Log Book Owner’s Manual Protective Wallet Warranty Card 2 x 1.5V AAA Alkaline Batteries Quick Start User Guide For replacing test strips, control solutions, and sterile lancets please contact your place of purchase for assistance. NOTE If any items are missing from your kit or opened prior to use, please contact your local customer services or place of purchase for assistance.
Meter Overview Top SET Left Side Front Right Side Back TEST STRIP EJECTOR Eject the used strip by pushing this button up. DISPLAY SCREEN M BUTTON Enter the meter memory and silence a reminder alarm. TEST SLOT Insert test strip here to turn the meter on for testing. DATA PORT Download test results with the cable connection. SET BUTTON Enter and confirm the meter settings.
Display Screen Test Result Test Strip Symbol Ketone Warning Low Battery Symbol Error Message Memory Mode Symbol Control Solution Mode Measuring Mode Blood Drop Symbol 10 Measurement Unit Reminder Alarm Day Average Time
Test Strip Absorbent Hole Apply a drop of blood here. The blood will be automatically absorbed. Confirmation Window This shows 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 meter. Push it in firmly until it will go no further. 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. To Enter the Setting Mode Start with the meter off (no test strip inserted). Press SET to turn on the meter. 1. Setting the date With the year flashing, press and release the M button to choose the correct year. Press SET.
2. Setting the time format Press the M button to select the desired time format --- 12h or 24h. Press SET. 3. Setting the time With the hour flashing, press and release the M button to choose the correct hour. Press SET. With the minute flashing, press and release the M button to choose the correct minute. Press SET. 4. Deleting the Memory. ” symbol on the display, press With “dEL” and a flashing “ the M button and select “No” to keep the results in memory then press SET to skip.
5. Setting the reminder alarm You may set up any or all of the reminder alarms (1-4). The meter displays “On” or “OFF” and , press the M button to turn on or turn off to set the first reminder alarm. Press the M button to select “On”, then press SET to set the hour. When the hour is flashing, press the M button to add an hour. Press SET to confirm and go to minutes, press the M button to add one minute. Hold the M button longer to add faster. Press SET to confirm and go to the next alarm setting.
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, regardless of 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.
BEFORE TESTING Control Solution Testing UltraTRAK 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 correctly.
2. Press the M button to mark this test as a control solution test. If you press the M button again, the “QC” will disappear and this test is no longer a control solution test. 3. Apply Control Solution. Shake the control solution vial thoroughly before use. Squeeze out a drop and wipe it off, then squeeze another drop and place it on the tip of the vial cap. Hold the meter to move the absorbent hole of the test strip to touch the drop.
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, as it should fall within the printed range. If not, please read instructions again and repeat the control solution test. 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.
GETTING A BLOOD SAMPLE Overview of the Lancing Device Lancet Holder Ejector Cap Adjustable Tip Depth Indicator Release Button Cocking Control Arrow If your lancing device differs from the one shown above, 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.
3. Twist the protective disk off the lancet. 4. Replace the cap by aligning the arrow on the cap with the release button. 5. Select the depth of penetration by turning the adjustable tip in either direction so that the arrow on the cap points to the desired depth. 6. Pull the cocking control back until it clicks. You will see a colour change inside the release button when it is ready. The lancing device is now ready for use. Set aside for later use.
Preparing the Puncture Site. Stimulating blood perfusion by rubbing the puncture site before blood extraction has a significant influence on the glucose value obtained. Please follow the suggestions below before obtaining a drop of blood: * Wash and dry your hands before starting. * Select the puncture site at fingertips. * Clean the puncture site using cotton moistened with 70% alcohol and let it air dry. * Rub the puncture site for about 20 seconds before penetration.
Performing a Blood Glucose Test 1. Insert the Test Strip to Turn on the Meter Wait for the meter to display the test strip symbols with Gen preset. and blood drop 2. Select the appropriate measuring mode by pressing the M button. For selecting the measuring mode, please refer to the “FOUR MEASURING MODES” section. 3. Obtain a Blood Sample Use the pre-set lancing device to puncture the desired site. After penetration, discard the first drop of blood with a clean cotton swab.
4. Apply the Sample Hold the blood drop to touch the absorbent hole of the test strip. Blood will be drawn in and after the confirmation window is completely filled, the meter begins counting down. NOTE Do not press the 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.
5.Read the Result The result of your blood glucose test will appear after the meter counts to 0. This reading will automatically be stored in the memory. 6.Eject the Used Test Strip and Remove the Lancet To eject the test strip, point the strip at a sharp disposal container. The meter will turn itself off automatically after the test strip is ejected Always follow the instructions in the lancing device insert when removing the lancet. WARNING The used lancet and test strip may be biohazardous.
METER MEMORY The meter stores the 1000 most recent blood glucose test results along with respective dates and times in its memory. To enter the meter memory, start with the meter off. Reviewing Test Results 1. Press and release the M button. will appear on the display. Press the M button again, and the first reading you see is the last blood glucose result along with date, time and the measuring mode. 2. Press the M button to recall the test results stored in the meter with each press. 3.
Reviewing Blood Glucose Day Average Results 1. Press and release the M button appears on the display, keep pressing the M button for 3 When seconds until the flashing “ ” appears. Release the M button and then your 7-day average result measured in general mode will appear on the display. 2. Press the M button to review 14-, 21-, 28-, 60- and 90- day average results stored in each measuring mode in the order of Gen, AC, then PC.
2. Exit the meter memory Keep pressing the M button and the meter will turn off after displaying the last test result. NOTE Any time you wish to exit the memory, keep pressing the M button 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.
Downloading Results onto a Computer You can use the 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 your local customer service or the place of purchase for assistance. 1. Obtaining the required cable and installing the software For downloading Health Care Software System, please visit the Vertex Diagnostics, http://www.vertexdiagnostics.
MAINTENANCE Battery Your meter comes with two1.5V AAA size alkaline batteries. Low Battery Signal The meter will display one of the below messages 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 batteries. 2. The symbol appears with E-b, error message and low: The power is not enough to do a test. Please change the batteries immediately.
NOTE Replacing the batteries does not affect the test results stored in 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). Properly dispose of the batteries according to your local environmental regulations.
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 rinse the meter 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 expiry 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 UltraTRAK control solutions with your meter. Do not use the control solution beyond the expiry date or 1.
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). Appears when your result is equal to or higher than 240 mg/dL (13.3 mmol/L).
Error Messages MESSAGE WHAT IT MEANS WHAT TO DO Appears when the batteries cannot provide enough power for a test. Replace the batteries immediately. Appears when a used test strip is inserted. Repeat with a new test strip. Repeat the test with a new test strip. Problem in operation. Appears when test strip is removed while counting down, or insufficient blood volume. Appears when ambient temperature is below system operation range. Appears when ambient temperature is above system operation range.
Troubleshooting 1. If the meter does not display a message after inserting a test strip: POSSIBLE CAUSE WHAT TO DO Batteries are exhausted. Replace the batteries. 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 plasma equivalent results. The result you obtain from your meter may differ somewhat from your laboratory result due to normal variation. Meter results may 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.: UTUBGM Dimension & Weight: 96 (L) x 61 (W) x 26 (H) mm, 67.2 g Power source: Two 1.5V AAA alkaline batteries Display: LCD Memory: 1000 measurement results with respective date and time External output: USB Cable Auto electrode inserting detection Auto sample loading detection Auto reaction time count-down Auto shutdown after 3 minutes of idleness Temperature Warning Operating condition: 50°F to 104°F (10°C to 40°C), below 85% R.H.
MEMO 40
