BLOOD GLUCOSE METER / GLYCOMÈTRE User’s Manual Manuel de l'utilisateur
Whether the Accu-Chek Aviva Meter is your first blood glucose meter or you have used a meter for some time; please take the time to read this manual carefully before you use your new meter. To use it correctly and dependably, you need to understand its operation, screen displays, and individual features. This User’s Manual may tell you a lot of what you already know, but it will also introduce many new features.
2 The Accu-Chek® Aviva System The Accu-Chek Aviva Meter is for quantitative blood glucose testing using Accu-Chek Aviva Test Strips. The Accu-Chek Aviva Meter may be used by patients who test their own blood glucose as well as by healthcare professionals for monitoring patients' blood glucose values. Suitable for self-testing.
Need Help? Call Accu-Chek Customer Care at 1-800-363-7949. Our address: Roche Diagnostics 201, Boulevard Armand Frappier Laval, Québec (CANADA) H7V 4A2 Please complete the warranty card and mail it to the address above, so you receive the best customer service possible and product update news. Important Information About Your New Meter • Your new meter is designed for testing fresh capillary whole blood samples (for example, blood from your fingertip or forearm).
4 Contents Chapter 1: Understanding Your New System ........................................................6 The Accu-Chek Aviva Meter ..............................................................................6 Coding the Meter ..............................................................................................8 Adjusting the Time and Date—First Time Use .................................................10 Using the Accu-Chek Aviva System ......................................................
Chapter 4: Control Testing ..................................................................................47 Why Perform Control Tests ..............................................................................47 About the Control Solutions .............................................................................48 Performing a Control Test ................................................................................49 Understanding Control Test Results .........................................
Chapter 1: Understanding Your New System The Accu-Chek Aviva Meter 6 Infrared (IR) Window – Transfers data from the meter to a computer or PDA. On/Off/Set Button – Turns the meter on or off and sets options. Display – Shows results, messages, and results stored in memory. Code Chip Slot – Insert code chip into this opening. Right and Left Arrow Buttons – Press to enter memory, adjust settings, and scroll through results.
Golden End – Insert this end of the test strip into the meter. 7 Yellow Window – Touch blood drop or control solution here. Test Strip On/Off/Set Button Top View Infrared (IR) Window Test Strip Container Code Chip (for example) Control Solution Bottle Battery – Insert with (+) symbol facing up.
Coding the Meter 8 1. Make sure the meter is off. ▲ ! 2. Turn the meter over. 3. Remove the old code chip (if there is one in the meter) and discard it.
9 4. Turn the code chip over so the code number faces away from you. Push it into the code chip slot until it stops. 5. Leave the code chip in the meter until you open a new box of test strips. Notes: • Do not force the code chip into the meter—it is designed to go into the meter only one way. • If you see a code “- - -” on the display, insert a code chip into the meter.
Adjusting the Time and Date—First Time Use Setting the correct time and date in the meter is important if you use the meter memory or if you want to download your results to a computer. 10 decrease 1. Press and release to turn the meter on. The time and date appear on the display. “Set-up” and the hour flash. increase 2. Press and release or to decrease or increase the hour. Press and hold or down to scroll faster. 3. Press and release to set the hour. The minutes flash.
Note: When you install a new battery, the meter automatically prompts you to check the time and date when you turn it on. 11 decrease increase 4. Press and release or to adjust the minutes. Press to set the minutes. 5. Repeat to set the am/pm, month, day, and year. 6. Once you set the year, press and hold until the flashing test strip symbol appears. The time and date are now set. 7. See Chapter 3 “Meter Set-up” to set other options.
Using the Accu-Chek Aviva System • Only use Accu-Chek Aviva Test Strips. 12 • Change the code chip every time you open a new box of test strips. • Store the unused test strips in their original container. • Close the container tightly immediately after you take a test strip out. This helps keep the test strips dry. • Use the test strip immediately after you take it out of the container. ! ▲ • Be sure to check the expiry date on the test strip container. Do not use the test strips after that date.
Chapter 2: Testing Your Blood Glucose Performing a Blood Glucose Test Before you perform your first blood glucose test, set up the meter correctly. You need the meter, a test strip, a lancing device, and a lancet. 13 1. Wash and dry your hands. 2. Prepare the lancing device. 3. Insert the test strip into the meter in the direction of the arrow. The meter turns on.
Performing a Blood Glucose Test (continued) 14 4. Make sure the code number on the display matches the code number on the test strip container. If you miss seeing the code number, remove the test strip and reinsert it into the meter. 5. A test strip and flashing blood drop symbol appear on the display.
15 6. Poke your fingertip with the lancing device. 7. Gently squeeze your finger to assist the flow of blood. This helps you get a blood drop.
Performing a Blood Glucose Test (continued) 16 8. Touch the blood drop to the front edge of the yellow window of the test strip. Do not put blood on top of the test strip. When you see flash, you have enough blood in the test strip. If you applied blood but do not see the flashing , you may reapply more blood within five seconds.
Note: After a successful test, the meter turns itself off five seconds after the test strip is removed. 17 9. The result appears on the display. If you want to flag the test result for a special event, leave the test strip in the meter. (See the next section.) Otherwise, remove and discard the used test strip.
Flagging Test Results If you wish, you can “flag” your test result with an asterisk ( ) to mark a special result. For example, you might want to flag an event such as an AST result or exercise. When you review the results in memory, this “flag” can help you remember what was different about the result. Here is how to flag a result: 18 1. Perform a test. 2. With the test result on the display, and the test strip STILL IN THE METER, press or once. The appears in the lower right corner. 3.
Alternate Site Testing (AST) You have the option of testing other sites on your body besides the fingertip. Blood obtained from a fingertip can be used at any time to measure blood glucose. If blood from an alternate site— palm, forearm, upper arm, thigh, or calf—is used, there are certain times when testing is not appropriate (see next page). This is because your glucose level changes quicker in your fingertip than in the alternate sites.
! ▲ 20 Do not change your treatment because of just one result. NEVER ignore symptoms of high or low blood glucose. If your blood glucose result does not match how you feel, perform a fingertip test to confirm your result. If the fingertip result still does not match how you feel, see Chapter 2 “Unusual Test Results.
You need the meter, a test strip, a lancing device designed for AST, and a lancet. 21 1. Prepare the lancing device. 2. Insert the test strip into the meter in the direction of the arrow. The meter turns on. 3. Make sure the code number on the display matches the code number on the test strip container. If you miss seeing the code number, remove the test strip and reinsert it into the meter.
Alternate Site Testing (AST) (continued) 22 4. A test strip and flashing blood drop symbol appear on the display. 5. Press the lancing device firmly against a fleshy area on the alternate site. Press the lancing device up and down in a slow pumping motion to assist the flow of blood.
Note: If the blood drop is too small, reapply pressure to get a sufficient blood drop. 23 6. Trigger the lancing device while keeping steady pressure on the site. Apply pressure to the site with the lancing device to assist the flow of blood. 7. Touch the blood drop to the front edge of the yellow window of the test strip. When you see flash, you have enough blood in the test strip. If you applied blood but do not see the flashing , you may reapply more blood within five seconds.
Normal Blood Glucose Values These test strips are calibrated to deliver plasma-like results. The normal fasting blood glucose range for an adult without diabetes as related to plasma is 4.1–5.9 mmol/L.1 For people with diabetes: Please consult your diabetes team for the blood glucose range appropriate for you. 24 You should treat your low or high blood glucose as recommended by your healthcare professional.
Unusual Test Results If your blood glucose result does not match how you feel, follow these steps: Troubleshooting Checks Action 1. Check if the test strips were expired. Discard the test strips if they are past the expiry date. 2. Check if the cap on the test strip container was always closed tightly. Replace the test strips if you think they were uncapped for some time. 3. Check if the test strip was out of the container for a long time. Repeat the test with a new test strip. 4.
26 Troubleshooting Checks Action 5. Check if you followed the testing steps. Read Chapter 2 “Testing Your Blood Glucose” and test again. If you still have problems, call Accu-Chek Customer Care at 1-800-363-7949. 6. Check if the code number on the meter display matches the code number on the test strip container. If they do not match, insert the correct code chip into the meter and test again. 7.
Symptoms of High or Low Blood Glucose Being aware of the symptoms of high or low blood glucose can help you understand your test results and decide what to do if they seem unusual. Here are the most common symptoms: High blood glucose (hyperglycemia): fatigue, increased appetite or thirst, frequent urination, blurred vision, headache, or general aching. Low blood glucose (hypoglycemia): sweating, trembling, blurred vision, rapid heartbeat, tingling, or numbness around mouth or fingertips.
Chapter 3: Meter Memory, Set-up, and Downloading Memory Storing Test Results The meter automatically stores up to 500 blood glucose test results with the time and date of the test. You can review them at any time. Test results are stored from the newest to the oldest, so it is very important to set the correct time and date in the meter. Having the correct time and date setting helps ensure appropriate interpretation of stored blood glucose results 28 by you and your healthcare team.
Notes: • Do not change your therapy based on one individual result in memory. • The memory is not lost when you replace the battery. You do need to check that the time and date are correct after you replace the battery. See Chapter 1 “Adjusting the Time and Date.” • Once 500 results are in memory, adding a new result causes the oldest one to be deleted. or down to scroll through the results faster. • Hold • Up to 20 control results are stored in memory, but cannot be reviewed on the meter.
Viewing Test Results Press either or to view the memory. The most recent result appears. Press to view previous results in order. OR Press to look at the 7, 14, or 30 day averages, in that order.
Meter Set-up Using the Set-up Mode By using the set-up mode, you can personalize the meter to suit your lifestyle. Here are the features you can customize— Time and Date—set the time and date. Beeper—select on or off. Alarm clock—select on or off. If you choose on, select 1 to 4 times a day for a reminder to test. Hypo alarm—select on or off. If you choose on, choose the blood glucose level for the alarm. Using the set-up mode is easy. The • With the meter on, press and hold “set-up” flashes on the display.
You are here TIME / DATE (hrs, min, am/pm, month, day, year) BEEPER (on/off) ALARM CLOCK (A-1, A-2, A-3, A-4) HYPO ALARM (off, on, level) Setting the Time and Date 32 decrease 1. Press to turn the meter on. The flashing test strip symbol appears. 2. Enter the set-up mode (press and hold for about four seconds). "Set-up” and the hour flash on the display. increase 3. Press and release or to decrease or increase the hour.
Note: Press and hold or down to scroll faster. decrease increase 33 4. Press and release The minutes flash. to set the hour. or 5. Press and release adjust the minutes. Press minutes.
Setting the Time and Date (continued) 34 6. Repeat to set the am/pm, month, day, and year. 7. If you want to set up more options, press and release . If you want to exit, press and hold until you see the flashing test strip symbol.
You are here TIME / DATE (hrs, min, am/pm, month, day, year) BEEPER (on/off) ALARM CLOCK (A-1, A-2, A-3, A-4) HYPO ALARM (off, on, level) Setting the Beeper On/Off Your new meter has the beeper pre-set to “On.” You can set the beeper to “OFF,” if you prefer—this will not affect your test results.
Setting the Beeper On/Off (continued) 36 1. Press to turn the meter on. The flashing test strip symbol appears. 2. Enter the set-up mode (press and hold for about four seconds). “Set-up” and the hour flash on the display. 3. Press and release repeatedly until you reach the display with the flashing beeper symbol and “On” or “OFF.
37 4. Press or “On” or “OFF.” to switch between 5. If you want to set up more options, press and release . If you want to exit, press and hold until you see the flashing test strip symbol.
You are here TIME / DATE (hrs, min, am/pm, month, day, year) BEEPER (on/off) ALARM CLOCK (A-1, A-2, A-3, A-4) HYPO ALARM (off, on, level) Setting the Alarm Clock Function The alarm clock function is a handy way to remind you to test. You can set up to four alarms per day. The meter beeps every two minutes—up to three times. You can turn the alarm off by inserting a test strip or pressing any button. You must have the beeper set to “On” for the 38 alarm to sound.
When you are setting the time for the alarm clock function, the bell symbol remains on the display and “set-up” flashes continuously. 39 1. Press to turn the meter on. The flashing test strip symbol appears. 2. Enter the set-up mode for (press and hold about four seconds). “Set-up” and the hour flash on the display. 3. Press and release repeatedly until you reach the display with the bell symbol, “OFF,” and the flashing “set-up” and “A-1.
Setting the Alarm Clock Function (continued) 40 4. Press and release or to switch between “On” or “OFF.” Press and release to set your choice. 5. If you select “On,” the hour flashes. “A-1” and the bell symbol remain on the display. 6. Press and release or to select the hour. Press and release to set the hour.
41 7. The minutes flash. Press and release or to select 00, 15, 30, or 45. These are the only choices. 8. Press and release to set the minutes. “Am” or “pm” flashes on the display. Press or to switch between am and pm. Press and release to set am or pm. 9. The next alarm “A-2” and “set-up” flash on the display with “OFF” and the bell symbol. You can either set a second alarm or press and hold until you see the flashing test strip symbol to exit the set-up mode.
You are here TIME / DATE (hrs, min, am/pm, month, day, year) BEEPER (on/off) ALARM CLOCK (A-1, A-2, A-3, A-4) HYPO ALARM (off, on, level) Setting the Hypoglycemic (Hypo) Alarm Function You can set the meter to let you know when your blood glucose is possibly too low. You can also select what blood glucose level you 42 want this alarm to have (3.3 to 4.4 mmol/L). Before you set the hypo alarm, talk to your healthcare professional to help you decide what blood glucose level is your hypo level.
43 2. Enter the set-up mode (press and hold for about four seconds). “Set-up” and the hour flash on the display. 3. Press and release repeatedly until you reach the display with “OFF” and the flashing “set-up” and . 4. Press and release or to switch between “On” and “OFF.” Press and release to set your choice.
Setting the Hypoglycemic (Hypo) Alarm Function (continued) 44 5. If you select “On,” “set-up” and flash. The display shows 3.9 mmol/L. ! ▲ 6. Press and release or to select the level you want. Press and release to set it. 7. Press and hold until you see the flashing test strip symbol to exit the set-up mode. This function is no substitute for hypoglycemia training by your healthcare professional.
Downloading Your Results to a Computer or PDA You can transfer your stored results to a computer to track, identify patterns, and print. Infrared (IR) Window Transferring Data Directly to a Computer or PDA Using Specialized Software and Infrared Cable 1. Install the software according to the instructions. To transfer the results to a computer, connect the infrared meter cable according to the instructions. 2. Run the software program and follow the instructions about how to download information.
Downloading Your Results to a Computer or PDA (continued) 6. Put the meter on a flat surface. Point the two IR windows toward each other. They should be 3 to 10 cm apart. 7. Do not move the infrared cable (computer), PDA, or meter during the transfer. 8. Follow the prompts on the software. 46 9. The software program may shut off the meter automatically when the data transfer is complete. Notes: • If the data did not transfer successfully, try again.
Chapter 4: Control Testing Why Perform Control Tests Performing a control test lets you know that the meter and test strips are working properly to give reliable results.
About the Control Solutions • Only use Accu-Chek Aviva Control Solutions. • The meter automatically recognizes the Accu-Chek Aviva Control Solution. • The control solution results are not displayed in memory. • Write the date you opened the bottle on the bottle label. The solution is good for three months from that date or until the expiry date on the bottle label, whichever comes first. • Do not use control solution that is past the expiry date. • The solution can stain clothing.
Performing a Control Test You need the meter, a test strip, and control solution Level 1 or Level 2. The control level is printed on the bottle label. 49 1. Insert the test strip into the meter in the direction of the arrow. The meter turns on. 2. Make sure the code number on the display matches the code number on the test strip container. If you miss seeing the code number, remove the test strip and reinsert it into the meter.
Performing a Control Test (continued) or 50 3. Select the control solution you want to test. You will enter the level later in the test. 4. Put the meter on a flat surface, like a table. 5. Remove the control bottle cap. Wipe the tip of the bottle with a tissue.
51 6. Squeeze the bottle until a tiny drop forms at the tip. Touch the drop to the front edge of the yellow window of the test strip. When you see flash, you have enough control solution in the test strip. Wipe the tip of the bottle with a tissue, then cap the bottle tightly. 7. The result appears on the display, along with the control bottle symbol and flashing “L.” Do not remove the test strip yet. Press once to mark the result as a Level 1. If you tested the Level 2 control, press a second time.
Performing a Control Test (continued) 52 8. Press meter. to set the control level in the 9. “OK” and the control result alternate on the display if the result is in range. The range is printed on the test strip container label. “Err” and the control result alternate on the display if the result is not in range. Remove and discard the used test strip.
Understanding Control Test Results Level 1 Level 2 Range (mmol/L) 1.4–3.1 14.2–19.1 Example 53 The label on the test strip container shows the acceptable ranges for both the Level 1 and Level 2 control solutions. The result you get should be inside this range. Make sure you compare the result to the correct level of control. When the control result is inside the range on the test strip container, the test strips and meter are working properly.
If the control result is not inside the acceptable range, here are some things you can do to solve the problem: 54 Troubleshooting Checks Action 1. Check if the test strips or control solutions were expired. Discard the test strips or control solutions if either is past the expiry date. If the control solution was opened more than three months ago, discard it. 2. Check if you wiped the tip of the control solution bottle before and after use. Wipe the tip of the bottle with a tissue.
Troubleshooting Checks Action 6. Check if you followed the testing steps. Read Chapter 4 “Control Testing” and test again. If you still have problems, call Accu-Chek Customer Care. 7. Check if you chose the correct control solution level, either 1 or 2, when you performed the test. If you chose the wrong control solution level, you can still compare the control result to the range printed on the test strip container. 8.
Chapter 5: Maintenance and Troubleshooting Changing the Battery 56 1. Open the battery door on the back of the meter by pushing the tab in the direction of the arrow and pulling the door up. Remove the old battery. 2. Insert the new battery with the + side up. 3. Put the battery door back in place and snap it closed.
Notes: • The meter uses one 3-volt lithium battery, type 2032. This type of battery can be found in many stores. It is a good idea to have a spare battery on hand. • Be sure the battery goes in + side up or facing you. • After you change the battery, the meter prompts you to confirm the meter’s time and date settings. See Chapter 1 “Adjusting the Time and Date.” All test results are saved in memory.
Cleaning the Meter Caring for the Accu-Chek Aviva Meter is easy—just keep it free of dust.
Maintenance and Troubleshooting The meter needs little or no maintenance with normal use. It automatically tests its own systems every time you turn it on and lets you know if something is wrong. (See Chapter 5 on “Screen Messages and Troubleshooting.”) If you drop the meter or think it is not giving accurate results, call Accu-Chek Customer Care at 1-800-363-7949. To make sure the display is working properly, turn the meter off, then press and hold to see the complete display.
Screen Messages and Troubleshooting ! ▲ Never make treatment decisions based on an error message. If you have any concerns, call Accu-Chek Customer Care at 1-800-363-7949. The meter will not turn on or the display is blank.
Battery power is low. Change the battery soon. See Chapter 5 “Changing the Battery.” The meter is ready for you to insert a test strip. The meter is in set-up mode, waiting for you to change or confirm settings. See Chapter 3 “Meter Set-up.” The meter is ready for a drop of blood or control solution.
62 Blood glucose may be higher than the measuring range of the system. The test result was flagged. See Chapter 2 “Flagging Test Results.” Blood glucose may be lower than the measuring range of the system. Blood glucose is below the defined hypo (low blood glucose) level.
The meter is not coded or the code chip is not inserted. Turn off the meter and recode it. See Chapter 1 “Coding the Meter.” The test strips expire at the end of the current month. Before the end of the month, insert a new code chip from a new box of test strips and ensure the code chip number matches the code number on the test strip container. Make sure the time and date in the meter are correct.
64 Your blood glucose level may be extremely low, or the test strip may be damaged or not properly inserted. If you see this error message after you applied blood to the test strip, see Chapter 2 “Unusual Test Results.” If you see this error message before you applied blood to the test strip, remove the test strip and reinsert it, or replace it if damaged. If the message reappears, call Accu-Chek Customer Care. The code chip is incorrect. Turn the meter off and insert a new code chip.
Not enough blood or control solution was drawn into the test strip for measurement or was applied after the test had started. Discard the test strip and repeat the test. The code chip is from an expired lot of test strips. Ensure the code chip number matches the code number on the test strip container. Make sure the time and date in the meter are correct. Blood or control solution was applied to the test strip before the flashing blood drop symbol appeared on the display.
The temperature is above or below the proper range for the meter (6°C to 44°C). Move to an area between 6°C and 44°C, wait five minutes and repeat the test. Do not artificially heat or cool the meter. 66 The battery is almost out of power. Change the battery now. See Chapter 5 “Changing the Battery.” The time and date settings may be incorrect. Make sure the time and date are correct and adjust, if necessary. See Chapter 3 “Setting the Time and Date.
Chapter 6: Technical Information Product Limitations Please read the literature packaged with your test strips to find the latest information on product specifications and limitations. Specifications Blood volume Sample type Measuring time Measuring range Test strip storage conditions Meter storage conditions System operating conditions Relative humidity operating range 0.6 µL Fresh capillary whole blood 5 seconds 0.6–33.
Memory capacity Automatic power off Power supply Display Dimensions Weight Construction Protection class Meter type Control solution storage conditions 500 blood glucose and 20 control results with time and date 2 minutes One 3-volt lithium battery (type 2032) LCD 94 x 53 x 22 mm (LWH) Approx.
Performance Analysis The performance data for the Accu-Chek Aviva System (Accu-Chek Aviva Meter with Accu-Chek Aviva Test Strips) were obtained using capillary blood from diabetic patients (method comparison, accuracy), venous blood (repeatability) and control solution (reproducibility). The system is calibrated with venous blood containing various levels of glucose. The reference values are obtained using the hexokinase method.
Product Safety Information ! ▲ ! ▲ Strong electromagnetic fields may interfere with the proper operation of the meter. Do not use this meter close to sources of strong electromagnetic radiation. To avoid electrostatic discharge, do not use the meter in a very dry environment, especially one in which synthetic materials are present. Disposing of the Meter During blood glucose measurement, the meter itself may come into contact with blood. Used meters therefore carry a risk of infection.
Explanation of Symbols On packaging, on the back of meter, and in the instructions for your Accu-Chek Aviva Meter, you may encounter the following symbols, shown here with their meaning. Consult the instructions for use Caution (refer to accompanying documents). Please refer to safety-related notes in the manual accompanying this instrument. Store at Manufacturer Catalogue number Listed by Underwriter's Laboratories, Inc.© in accordance with UL 61010A-1 and CAN/CSA C22.2 No.1010-1.
Warranty and Service Roche Diagnostics warrants the meter against any material and manufacturing defects that may arise during proper use of the instrument. For precise terms and conditions please see the warranty card in the box. This warranty does not affect any statutory or other rights. The warranty ceases to apply if the instrument has been misused or tampered with. Roche undertakes to replace faulty components free of charge or, at their discretion, to provide fault-free replacement meter.
Additional Supplies The following supplies and accessories are available from your authorized Roche Diagnostics Diabetes Healthcare Center, pharmacies, or your medical/surgical supply dealer: Test Strips Accu-Chek Aviva Test Strips Control Solutions Accu-Chek Aviva Control Solutions Catalogue numbers Accu-Chek Aviva Care Kit 04422058164 Accu-Chek Aviva Test Strips (10ct) 04454316164 Accu-Chek Aviva Test Strips (50ct) 04454308164 Accu-Chek Aviva Test Strips (100ct) 04538412164 Accu-Chek Aviva Cont
Information for Healthcare Professionals ! ▲ Healthcare Professionals: Follow the infection control procedures appropriate for your facility. WARNING: Patients receiving peritoneal dialysis using solutions containing Icodextrin (e.g. Extraneal, Icodial) should not use the Accu-Chek Aviva Test Strip. It could cause an overestimation of glucose results.
Index alarm clock function, setting, 38 alternate site testing, 19, 74 appetite, increased, 27 battery, changing, 56 battery, installing, 56 battery, type, 57 beeper, setting, 35 blood glucose, testing, 13 blurred vision, 27 button, on/off/set, 6, 7 code chip, 7, 8 computer, connecting the meter to, 45 control solution, 48 control test results, understanding, 53 control test, acceptable range, 53 control test, performing, 49 control test, results, 53 control test, unacceptable range, 53 display check, 59 e
test results, unusual, 25 test strips, Accu-Chek Aviva, 7, 12 thirst, increased, 27 time and date, setting, 32 tingling, 27 trembling, 27 troubleshooting, 60–66 warranty, 72 76
