GLUCOCARD X-mini plus INT-IVD mmol Operating Manual (83-04345) page 1 FRONT 2.2 What You Need for Each Test Chapter 10 Technical Information 10.1 Specifications Product Model Test item Sample Sample size Test strips Unit of measure Test range Test time Temperature compensation Battery Battery life Power consumption Memory capacity Clock accuracy Operating environment Expected life Dimensions Weight GLUCOCARDTM X-mini plus GT-1960 Blood glucose level Fresh capillary whole blood*1 0.3 μL GLUCOCARDTM X premium Test Strips mmol/L 0.6 to 33.3 mmol/L 5 seconds from blood detection Automatic compensation using built-in thermo sensor a. GLUCOCARDTM X-mini plus (meter) 83-04341 Thank you for choosing the GLUCOCARDTM X-mini plus. We have designed this compact blood glucose meter for faster and easier testing of your blood glucose. We hope our product will help you manage your diabetes. This manual explains how to use your new meter. Before testing, carefully read through this manual and the package inserts that come with the GLUCOCARDTM X premium Test Strips and GLUCOCARDTM X-METER CONTROL. Pay particular attention to listed warnings and cautions. Please keep this manual handy for future reference. If you have any questions, please contact our authorized distributor(s) at the end of this manual. 3 V lithium battery (CR2032) × 2 Approx. 1,000 tests (Actual number of tests may be less under some conditions of use.) 0.02 W (Max.) 500 test results Within ±75 seconds/month Temperature: 10 to 40°C (50 to 104°F) Humidity: 20 to 80% RH (No condensation) 3 years (according to company data) L102 × W33 × 18.5 mm (L4.0 × W1.3 × 0.7 inches) Approx. 46 g (1.49 ounces) Chapter 1 Introduction *1: Although whole blood samples are used for measurement, displayed results are equivalent to plasma glucose levels. 1.1 Intended Use Your GLUCOCARDTM X-mini plus and GLUCOCARDTM X premium Test Strips are for quantitatively measuring the glucose level in fresh capillary whole blood. They are intended for use outside of the body (in vitro diagnostic use) at home or in a clinical setting as an aid to monitor and control blood glucose levels. Do not use them to diagnose diabetes. Also, do not alter treatment based on the test results of this meter without instructions from your doctor or healthcare professional. Store the meter at 0 to 50°C (32 to 122°F). The meter is shipped with the batteries loaded. So, you can start testing immediately. However, the batteries may not satisfy the “Battery life”. Product specifications and appearance are subject to change without notice. 1.2 Measurement Principle Glucose in the blood reacts with the reagent in the test strip and this produces a small electric current. The strength of this current is proportional to the concentration of glucose in the blood. The meter measures this current and calculates your glucose level. 1.3 What’s Included GLUCOCARDTM X-mini plus Carrying case Operating Manual (this manual) Simplified Manual / Information for Users MultiletTM (lancets)* Multi-Lancet DeviceTM (lancing device)* GLUCOCARDTM X premium Test Strips* Some kits do not include the above items with an asterisk (*). Chapter 2 Before Tests 2.1 Important Health-Related Information ( 84-04345 ) WARNING Do not use this meter for your blood glucose testing if you are being tested for galactose tolerance or xylose absorption. You may use this meter if you are taking PAM (1-Methylpyridine-6-carbaldehyde oxime). These treatments may produce higher test results than your actual blood glucose level. Taking unnecessary measures to lower your blood glucose level may induce severe low glucose symptoms such as coma. b. GLUCOCARDTM X premium Test Strips d. Lancet WARNING Keep the meter, test strips and other items away from young children. Small items are choking hazards. 2.3 Cautions on Using the Meter CAUTION For accurate test results, allow the meter to adjust to the surroundings: Temperature: 10 to 40°C (50 to 104°F) Humidity: 20 to 80% RH (Relative Humidity) for 30 minutes before testing your blood glucose. Do not store or use the meter where: • There are sharp temperature fluctuations. • Humidity is high enough to cause condensation (bathrooms, drying rooms, kitchen, etc.). • There is a strong electromagnetic field (microwave oven, cell phone, etc.). Do not use the meter after it has been dropped in liquid or liquids have entered inside, even if dried afterwards. Keep hands away from the test strip slot on the meter. A thermo sensor is housed inside the meter to minimize detection of errors. Do not connect the communication cable to the connection terminal during testing. The meter may be damaged, leading to inaccurate test results. Do not apply blood directly to the test strip slot on the meter. Do not share your meter with anyone to avoid the risk of infection. 2.4 Cautions on Using the Test Strips CAUTION Use only the GLUCOCARDTM X premium Test Strips for testing with the GLUCOCARDTM X-mini plus. Do not use other test strips as it causes inaccurate test results. Do not use test strips beyond their expiration date. The expiration date is written on the test strip bottle next to “Exp.”. For accurate test results, allow test strips to adjust to the surroundings: Temperature: 10 to 40°C (50 to 104°F) Humidity: 20 to 80% RH for 20 minutes before testing your blood glucose. Do not use the test strips if 6 months or more have passed since opening the bottle. The test strips are for single-use only. Do not use test strips that have already absorbed blood or control solution. NOTE Store test strips in their original bottle to maintain quality. Do not transfer them to other containers. 2.5 Meter Parts Strap hole Battery holder Display with backlight Test strip disposal lever Connection terminal Test strip slot with light Insert a test strip here before testing. REV. 2011.09 c. Lancing device Button GLUCOCARD X-mini plus INT-IVD mmol Operating Manual (83-04345) Button Operations This manual uses the following graphic icons to show you how to operate the button. Left Right Press the button once. Twice page 1 REAR Next ... Go to chapter 3 “Blood Sampling”. Draw blood and apply it to the test strip no more than 5 minutes after you insert the test strip into the meter. Double beeps begin to sound 4 minutes and 30 seconds after inserting the test strip. Thirty seconds later, the meter turns itself off. Chapter 8 Control Test Chapter 9 Meter Care This meter checks itself every time you insert a test strip. You do not need to run frequent control tests. Do a control test if: 9.1 Storing Your Meter NOTE In the ECO mode, the blood symbol flashes 2 minutes shorter than otherwise. See chapter 7 “Meter Setup”. Press the button the specified number of times. Slide the button to the right. Chapter 3 Blood Sampling Slide the button to the left. This chapter briefly explains how to get a blood sample using the Multi-Lancet DeviceTM and MultiletTM. If using some other lancing device to sample blood, see the manual for that device. Hold Hold the button in the direction of the arrow until the option you want appears on the screen. Hold for 5 seconds Hold the button in the direction of the arrow for the specified duration of time. 3.1 Lancing Device Parts MultiletTM (lancet) Multi-Lancet DeviceTM (lancing device) Head cap Holder Puncture button Adjustment dial Protective cap 2.6 Display Delete flag Control test flag HYPO flag Special band Band hooks Disposal-and-set lever Strap hole Sound mute symbol After-meal flag Battery symbol Displays the blood symbol, date and time, etc. Clock counter Meal amount flag Decimal point Thermometer symbol 2.7 Inserting Test Strips into the Meter 3.2 Cautions on Using the Multi-Lancet DeviceTM Follow these cautions to reduce the risk of infection by pathogenic microorganisms. CAUTION Wash the puncture site with soap and water. Dry the site thoroughly before sampling blood. Do not share the same lancet or lancing device with anyone to avoid the risk of infection. Always use a new lancet. Lancets are for single-use only. Do not reuse a lancet that you have already used. Start with the following steps to test your blood glucose level. 1. With clean, dry hands, remove 1 test strip from the bottle. Do not bend the test strip. NOTE Tightly close the bottle immediately after taking out a test strip. Do not apply blood to the test strip before inserting it into the meter. 2. Insert the test strip fully into the test strip slot. The meter turns on. Check that a full display appears as in chapter 2.6. After the most recent test result appears, the blood symbol will flash on the screen. If nothing appears on the screen, remove the test strip and insert it back into the test strip slot. NOTE You can turn on the test strip light. The test result that appears right after power turns on is the most recent result without a control test flag or delete flag. If the thermometer symbol appears on the screen, see “If a Message Appears” in the “Information for Users”. If you insert a test strip beyond the expiration date you set, the blood symbol and expiration symbol will alternately flash on the screen. If this occurs, see chapter 6.3. 3.3 Selecting a Sampling Site Alternative site testing (AST): This meter can test the glucose level of blood from your fingertip, palm, forearm or upper arm. However, test results from sites other than the fingertip may differ from a fingertip measurement. Consult your doctor or healthcare professional before testing blood from the palm, forearm or upper arm. Use blood from: If you are going to test: Fingertip, palm, forearm or upper arm Fingertip Before meals Two hours or more after meals Two hours or more after exercise When there is the possibility of blood glucose level changing rapidly (e.g. after meals or exercise) When experiencing symptoms of hypoglycemia such as perspiration, cold sweats, a floating sensation or trembling When immediate testing is needed for suspected hypoglycemia When in poor physical condition such as having a cold, etc. 3.4 Sampling from Your Fingertip 1. Remove the head cap. CAUTION If you cannot test your blood glucose due to a problem with your meter or test strips, promptly contact your healthcare professional and distributor. 2. Insert a new lancet into the holder until it stops. 3. To flag the test result: See step 2 in chapter 5.1. NOTE Use only the control solution, GLUCOCARDTM X-METER CONTROL, to test your meter and test strips CAUTION Do not use control solutions beyond their expiration date. The expiration date is written on the control solution bottles next to “Exp.”. Leave the meter and test strips at 10 to 40°C (50 to 104°F) and 20 to 80% RH, and the control solution at 22 to 28°C (72 to 82°F) for at least 30 minutes before running the control test. Do not drink control solution. It is not for human consumption. Keep control solution away from skin and eyes. Contact may cause inflammation. 1. See steps 1 and 2 in chapter 2.7. Before-meal flag After-exercise flag You suspect the meter or test strips are not working properly. You dropped the meter. You damaged the meter. Your test results do not match how you feel. You want to check performance of the meter and test strips before a blood glucose test. NOTE Use a lancet before its expiration date. 3. Twist off the protective cap on the lancet. Keep the protective cap for disposing of the lancet after the test. 2. Select the control test flag. As an alternative, you can attach the control test flag after the test result appears on the screen. Test results with the control test flag are not part of your result averages. 3. Make sure that the blood symbol is flashing on the screen. 4. Squeeze a drop of control solution to the tip of the test strip. After use, tightly close the caps of the test strip bottle and control solution bottle to maintain their quality. Store your meter, test strips, control solutions and manuals in your carrying case and store it in a dry location. The correct storage temperature is 0 to 50°C (32 to 122°F) for the meter and 1 to 30°C (34 to 86°F) for the test strips and control solutions. Do not freeze. Avoid heat, humidity and direct sunlight. CAUTION To obtain accurate test results: Do not use test strips or control solutions if their bottles are broken or have been left open. Do not use the test strips or control solutions beyond their expiration dates. 9.2 Cleaning Your Meter and Lancing Device Your meter and lancing device do not need special cleaning. If your meter and lancing device get dirty, wipe them with a soft piece of cloth moistened with water. To disinfect these items after cleaning, wipe with a soft cloth moistened with 70% ethanol, 70% isopropanol or diluted household bleach (0.05% sodium hypochlorite solution). 9.3 Changing the Batteries When the battery symbol appears on the screen, the batteries are getting low. Before using your meter, change the batteries. Past results remain in the memory even when the batteries are changed. NOTE Your meter uses two CR2032 3V lithium batteries. This type of batteries is available in many stores. Keep spare batteries handy at all times. The test will not start if you apply your control solution to the check window directly. You do not need to set the date and time if you insert new batteries within 1 minute after removing the old batteries. Even if you change the batteries within 1 minute, your meter’s clock may stop if: The test starts when the meter detects the control solution. The meter counts down from 5 to 1 during the test. The batteries are not replaced soon after the battery symbol appears. The batteries are inserted upside down. You touch the metal parts inside the meter with hands or metal. NOTE Tightly close the control solution bottle. Do not touch the test strip once the meter starts counting down. 1. Make sure the meter is off. 5. Check your test result is within the acceptable range. The acceptable range is shown on the package insert that come with the control solution. If within range, the meter and the test strip are working properly. If out of range, test the control solution again. CAUTION If you still have test results that are out of the acceptable range, stop using your meter, test strips and control solutions, and contact your distributor. 6. Slide the test strip disposal lever to eject the test strip. The meter turns itself off. 2. Grip the strap hole with the tip of your finger and pull open. 3. Remove the batteries. 4. Set the new batteries into the battery holder with the “+” side facing upward. NOTE If the batteries are inserted upside down, the meter will not operate. 5. Close the battery holder. 6. The “SET” screen appears when the time has been reset. If it appears, set the correct time. See the setup mode flowchart in chapter 7. If you do not set the time, all subsequent test results will be stored as 12:00 AM or 00:00. Dispose of old batteries according to your local environmental regulations. GLUCOCARD X-mini plus INT-IVD mmol Operating Manual (83-04345) page 2 FRONT 4. Attach the head cap to the lancing device body. Chapter 7 Meter Setup When you hear a beep, remove the test strip from the blood. The test starts when the meter detects enough amount of blood. The meter counts down from 5 to 1 during the test. Your meter is set up as below at the time of purchase. To change the settings, see the setup mode flowchart. Alarm: Off Result average display: 7d ECO: Off Beeper volume: High (3) Meal amount: Off Test strip expiration: Off Date: Current local date Bar graph: Upper limit 16.7 mmol/L, Lower limit 2.8 mmol/L Time: Current local time HYPO: Off 6. Wash the puncture site with soap and water. Dry thoroughly. Setup mode To go to “SET”: to follow the black arrows ( ). Alarm 1. Make sure the meter is off. Current setting 2. You can make 4 alarm settings. Hold for 5 seconds to follow the gray arrows ( ). Beeper volume Date Time Current setting Current setting Current setting 1. Select a setting. 1. Set the year. 1. Select a time format. 1. Select an alarm number. or A1, A2, A3 or A4 2. Turn on the alarm. to change the settings or numbers. or Hold to scroll through the settings or numbers: on1: Low on2: Normal on3: High oFF: Off To the top of the beeper volume setting. 12h or 24h 2. Set the month. 3. Set the day. 2. Set the hour. 3. Set the minute. 4. Select a date format. To the top of the time setting. 4. Set the minute. To make another alarm setting, repeat steps 1 to 4. To the top of the date setting. If you accidentally press the puncture button before reaching the puncture site, press the disposal-and-set lever until you hear a click. The device is then reset. HYPO (hypoglycemic) Bar graph Meal amount Result average display Current setting Current setting Current setting Current setting Current setting Current setting 1. Turn on the expiration warning. 1. Turn on the ECO mode. 1. Turn on the HYPO flag. 1. Set the upper limit of the graph. 1. Turn on the meal amount flag. 1. Select a setting. You will hear a beep when the test result appears on the screen. The meter stores this test result and the test date in the memory. 8. Obtain as much blood as that shown in “Actual size” on the right. Actual size: Next ... Go to chapter 4 “Testing Your Blood Glucose”. 3.5 Sampling from Your Palm, Forearm or Upper Arm 2. Select a soft, fleshy area on the palm, forearm or upper arm that is free of visible veins, moles and hair and away from bone. 3. Massage the puncture site. The date 6 months from the current date appears. To the top of the ECO mode setting. OK To change the date: See steps 1 to 3 in “Date.” To the top of the expiration setting. 7d, 14d, 30d or 90d 1.1 to 33.3 mmol/L 2. Set the threshold value. 2. Set the lower limit of the graph. 0.6 to 4.4 mmol/L A HYPO flag appears when your test results are below the threshold value. To the top of the HYPO setting. Bar graph Test results The 6 most recent test results appear as a bar graph, with the newest result at the far right. Upper limit Lower limit To switch the bar graph to the current date and time: If you obtained an insufficient amount of blood, rub or warm a new puncture site to increase blood flow. Then, make another puncture. 0.6 to 32.8 mmol/L To the top of the bar graph setting. To the top of the meal amount setting. If test results do not match how you feel: Make sure you performed the test properly as explained in chapters 2 to 4. Then, do a control test to check there are no problems with the meter or test strips. If you tested blood from the palm, forearm or upper arm, repeat the test with blood sample from a fingertip. If test results still do not match how you feel, contact your doctor or healthcare professional. Actual size: Next ... Go to chapter 4 “Testing Your Blood Glucose”. Chapter 4 Testing Your Blood Glucose 1. Make sure that the blood symbol is flashing on the screen. To the top of the result average display setting. 2. Touch the tip of the test strip to the drop of blood. Let the test strip draw up blood until the dark-colored check window is filled with blood. WARNING Test results are shown in mmol/L. You cannot change the unit of measure. If the results appear in mg/dL by any possibility, contact your distributor immediately. Using mg/dL may cause you to misread test results and lead to incorrect treatment. CAUTION If “Lo” or “Hi” appears on the screen: Repeat the test. If “Lo” or “Hi” still appears, contact your doctor or healthcare professional. “Lo” appears if your test result is less than 0.6 mmol/L. “Hi” appears if your test result is more than 33.3 mmol/L. If nothing appears on the screen, remove the test strip and insert it back into the slot. Then, wait until the blood symbol starts flashing. The ECO mode extends battery life. NOTE For accurate test results, touch the test strip to your blood in less than 20 seconds after puncturing. Do not test blood that runs or spreads out from the puncture site. Do not smear blood on the test strip. Do not press the test strip into your puncture site with force. If the meter does not start counting down, touch the test strip to the drop of blood again within 10 seconds. Use a new test strip if more than 10 seconds have passed. Keep your hands away from the test strip once the meter starts counting down. 3. Read your test result. 6. Hold the head cap against the site. Add and reduce pressure to the site repeatedly, one cycle per second, to obtain as much blood as that shown in “Actual size” on the right. Back to “Alarm” NOTE The meter turns itself off if left alone for 3 minutes (ECO mode: 1 minute). Your new settings will be saved. 7. Press the head cap against your fingertip and press the puncture button lightly. If you accidentally press the puncture button before reaching the puncture site, press the disposal-and-set lever until you hear a click. The device is then reset. To the top of the alarm setting. The meter turns off. Deeper 5. Press the head cap hard against the puncture site for about 10 seconds. Press the puncture button lightly. 5. Go to “End”. ECO 1 2 3 4 5 6 7 4. Wash the puncture site with soap and water. Dry thoroughly. d-n: Day-month n-d: Month-day Test strip expiration Level indications 1. See steps 1 to 5 in chapter 3.4. 3. Set the hour. Setup end 5. If needed, adjust the lancing depth by turning the adjustment dial. Do not ignore test results. Do not alter your blood glucose management or treatment without consulting your doctor or healthcare professional. It is important to follow their instructions. NOTE In the ECO mode, the test result appears on the screen 2 minutes shorter than otherwise. See chapter 7 “Meter Setup”. 4. Slide the test strip disposal lever to eject the test strip. The meter turns itself off. CAUTION Point your meter down and away from others when ejecting the used test strip. 5. Remove the used lancet from your lancing device. Accurate test results will not be obtained if you apply your blood to the check window directly. Remove the head cap from the lancing device body. Stab the protective cap with the tip of the lancet. Push the disposal-and-set lever in the direction of the arrow to remove the lancet. Disposal of Biohazardous Waste Test strips and lancets qualify as biohazardous waste once used to test blood glucose. After use, dispose of them according to your local regulations on biohazardous waste. GLUCOCARD X-mini plus INT-IVD mmol Operating Manual (83-04345) page 2 REAR 3. View the test result you want. Chapter 5 Managing Your Test Results Chapter 6 Useful Functions for Your Test To go to the next result: 5.1 Flagging Test Results Flags help you categorize and identify results. 1. Leave the test strip in the meter after the test result appears on the screen. To go back to the previous result: 2. Select the flag you want. To scroll through results: 1. Repeat steps 1 to 3 in “Before Your Meal: Starting the Clock Counter”. 6.1 Using the Alarm The alarm reminds you when to test your blood glucose. You can set the alarm to sound at 4 different times in a day. See chapter 7 “Meter Setup.” Hold To stop the alarm: 6.3 Managing the Expiration Date of Test Strips You can set the expiration date of test strips. The expiration warning then appears if you insert a test strip into the meter after the set date. 5.3 Viewing Result Averages You can view result averages for the set interval (7, 14, 30 or 90 days). Before-meal flag For results obtained before eating Setting the Expiration Date of Your Test Strips 6.2 Using the Clock Counter 1. See steps 1 and 2 in chapter 5.2. You can store after-meal results together with the time elapsed since the beginning of your last meal (up to 180 minutes). 2. View the averages of your glucose test results. After-meal flag For results obtained after eating mmol/L 3. To view the averages with a flag: Checking the Set Expiration Date 1. Make sure the meter is off. mmol/L 2. Go to the “DATE:” screen. 2. View the expiration date. The number of tests included in the calculation of the result average. Meal amount flag When the meal amount setting is on, the meal amount flag appears below the after-meal flag. 50% Select the amount of food you ate from the 3 levels shown on the left. 3. From the “DATE:” screen, go to the “Meal Time” screen. 4. To turn off the meter: Hold for 2 seconds 4. Turn on the clock counter. 5.4 Deleting All Test Results from the Memory You can delete all test results from the memory. Remember that results cannot be retrieved once deleted. After-exercise flag For results obtained after exercise 1. See steps 1 and 2 in chapter 5.2. 3. Slide the test strip disposal lever to eject the test strip. The meter turns itself off. 2. Go to the “AVG (average)” screen. 3. Go to the “ALL CLEAR” screen. 5.2 Reviewing Past Results You can review past results stored in the memory. Your meter stores up to 500 test results. New results beyond the 500th overwrite previously stored results in the order of oldest first. 2. Turn on the meter. The most recent test result appears on the screen. Hold for 2 seconds The meter then turns itself off. mmol/L The 3-digit number following “M:” is the order in which test results are stored, with the most recent result first. The screen also shows the date and time when the test was done. If you forgot to start the clock counter, select the time elapsed since the beginning of your last meal in 15-minute blocks. After the current date and time appear, the meter turns itself off. To view the elapsed time while the meter is off: 4. Select “YES”. 5. Delete the test results from the memory. 1. Make sure the meter is off. 5. When you are about to start your meal, go to step 6 with “0 min” flashing. 6. Start the clock counter. Hold for 5 seconds Hold for 2 seconds Testing after Your Meal: Changing the Elapsed Time 1. After eating, test your blood glucose. When the clock counter setting is on, the elapsed time and after-meal flag appear on the right of the test result. 2. To change (or set) the elapsed time: Select the time. The expiration date appears after the current date and time. Expiration Date Reminder 80% Full Select the earlier date of the following: • Six months from opening the test strip bottle • Date next to “Exp.” on the test strip bottle To set the expiration date, see chapter 7 “Meter Setup”. Before Your Meal: Starting the Clock Counter 1. Make sure the meter is off. Clock counter If the clock counter setting is on, the elapsed time appears on the right of the after-meal flag. See chapter 6.2. 3. Confirm your selection. A series of short beeps sound for 1 minute. Twice Control test flag Control test results. Not part of your result averages. Delete flag For inaccurate results. Not part of your result averages. The delete flag can be attached only after testing. 2. Select “no”. Setting the Alarm When the Alarm Reaches the Set Time 4. To turn off the meter: Stopping the Clock Counter Hold for 2 seconds or Confirm your setting. 3. Slide the test strip disposal lever to eject the test strip. The meter turns itself off and the test result is stored together with the elapsed time. Do not use the inserted test strip and other test strips in the same bottle, if the blood symbol and expiration symbol alternately flash on the screen.