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Reference Manual
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 booklet carefully before you use your new meter. To use it correctly and dependably, you need to understand its operation, screen displays, and all individual features. Should you have any questions, please call the Accu-Chek Customer Careline on 0800 701000 (UK) or 1 800 709600 (Ireland).
Any object coming into contact with human blood is a potential source of infection (see: Clinical and Laboratory Standards Institute: Protection of Laboratory Workers from Occupationally Acquired Infections; Approved Guideline Third Edition; CLSI document M29-A3, 2005).
Need Help?
If you have any questions, please call the Accu-Chek Customer Careline on 0800 701000 (UK) or 1 800 709600 (Ireland). Please remember to complete the warranty card and send it by post to Roche Diagnostics, so you receive the best customer service possible and news on product updates.
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The Accu-Chek Multiclix Finger Pricker is intended for patient selfmonitoring by a single person only. It must not be used to collect blood from more than one person as this poses an infection risk. Any object coming into contact with human blood is a potential source of infection (see: Clinical and Laboratory Standards Institute: Protection of Laboratory Workers from Occupationally Acquired Infections; Approved Guideline Third Edition; CLSI document M29-A3, 2005).
Contents
Chapter 1: Understanding Your New System .......................................................8 The Accu-Chek Aviva Meter ..............................................................................8 Coding the Meter ............................................................................................10 Adjusting the Time and Date First Time Use.................................................12 Using the Accu-Chek Aviva System .................................................................14 Chapter 2: Testing Your Blood Glucose ..............................................................15 Performing a Blood Glucose Test ....................................................................15 Flagging Test Results ......................................................................................20 Alternative Site Testing (AST) ..........................................................................21 Chapter 3: Meter Memory, Setup, and Downloading ..........................................29 Memory ..........................................................................................................29 Meter Setup ....................................................................................................31 Setting the Time and Date...............................................................................32 Setting the Beeper On/Off ...............................................................................35 Setting the Alarm Clock Function ....................................................................38 Setting the Hypoglycemic (Hypo) Alarm Function.............................................42 Downloading Your Results to a Computer or PDA ............................................45
6 Chapter 4: Control Testing ..................................................................................47 Why Perform Control Tests..............................................................................47 About the Control Solutions .............................................................................48 Performing a Control Test ...............................................................................49 Understanding Control Test Results .................................................................53 Chapter 5: Testing Blood Glucose in Multiple Patients ......................................56 Testing Blood Glucose .....................................................................................58 Disinfecting the Meter .....................................................................................62 What to Disinfect.............................................................................................62 How to Disinfect ..............................................................................................62 When to Disinfect ............................................................................................63 Suitable Disinfecting/Cleaning Solutions..........................................................63 Chapter 6: Maintenance and Troubleshooting ...................................................64 Changing the Battery.......................................................................................64 Cleaning the Meter ..........................................................................................66 Maintenance and Troubleshooting...................................................................67 Screen Messages and Troubleshooting ...........................................................68
7 Chapter 7: Technical Information .......................................................................75 Product Limitations .........................................................................................75 Specifications..................................................................................................75 Product Safety Information ..............................................................................77 Disposing of the Meter ....................................................................................77 Warranty and Service Instructions ...................................................................80 Additional Supplies..........................................................................................81 Information for Healthcare Professionals Alternative Site Testing (AST) ........82 Chapter 8: The Accu-Chek Multiclix Finger Pricker ...........................................83 Loading a Lancet Drum ...................................................................................85 Taking a Fingertip Blood Sample .....................................................................88 Taking an Alternative Site Blood Sample .........................................................89 Getting a Good Drop of Blood ..........................................................................92 Changing the Lancet Drum..............................................................................95 Caring for Your Finger Pricker .........................................................................96 Index ...............................................................................................................97
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. Battery Door Flip open the battery door by pushing the tab in the direction of the arrow. Code Chip Slot Insert code chip into this opening.
Golden End Insert this end of the test strip into the meter. Yellow Window Touch blood drop or control solution here. Test Strip Test Strip Container Control Solution Bottle
On/Off/Set Button
Top View
3. Remove the old code chip (if there is one in the meter) and discard it.
Inserting the code chip sets the meter to match the test strips. This codes the meter. Change the code chip every time you open a new box of test strips.
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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.
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1. Press and release to turn the meter on. The time and date appear on the display. Set-up and the hour flash.
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decrease
increase
3. Press and release to set the hour. The minutes flash.
2. Press and release or to decrease or increase the hour. Press and hold or down to scroll faster.
Note: When you install a new battery, the meter automatically prompts you to check the
time and date when you turn it on.
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4. Press and release or to adjust the minutes. Press to set the minutes.
5. Repeat to set the day, month, and year. 6. Once you set the year, press and hold until the flashing test strip
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decrease
increase
symbol appears. The time and date are now set. 7. See Chapter 3 Meter Setup to set other options.
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Do not store test strips in high heat and moisture areas (e.g., bathroom or kitchen)! Heat and moisture can damage the test strips.
! !
The Accu-Chek Multiclix Finger Pricker is intended for patient self-monitoring by a single person only. It must not be used to collect blood from more than one person as this poses an infection risk. Any object coming into contact with human blood is a potential source of infection (see: Clinical and Laboratory Standards Institute: Protection of Laboratory Workers from Occupationally Acquired Infections; Approved Guideline Third Edition; CLSI document M29-A3, 2005).
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1. Wash and dry your hands thoroughly. 2. Prepare the finger pricker according to the manufacturers instructions. 3. Insert the test strip into the meter in the direction of the arrows. The meter turns on automatically.
4. Make sure the code number on the display matches the code number on the test strip container. If you miss the code number on the display, remove the test strip and reinsert it into the meter.
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5. A test strip and flashing blood drop symbol appear on the display. 6. Let your arm hang down at your side briefly to allow blood to flow to your fingertips.
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7. Obtain a blood sample with the aid of the finger pricker. Blood samples taken from the palm are equivalent to blood taken from the fingertip. For detailed information on how to obtain blood from the palm, refer to the Alternative Site Testing (AST) section, steps 5 and 6.
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8. With your hand facing downwards, gently squeeze your finger to assist the flow of blood. This helps you get a blood drop.
9. 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.
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Note: After a successful test, the meter turns itself off five seconds after the test strip is removed. Refer to Chapter 8 Getting a Good Drop of Blood for helpful tips on getting a drop of blood. To reduce the risk of infection, change the lancet after each test. Blood glucose results are displayed in mmol/L. If your meter displays mg/dL, call the Accu-Chek Customer Careline on 0800 701000 (UK) or 1 800 7096000 (Ireland). Using the wrong meter can cause misinterpretation of the test result.
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10. 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.
flag
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hypothenar thenar
IMPORTANT
22 Talk to your healthcare professional about Alternative Site Testing.
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/palm test to confirm your result. If the fingertip/palm result still does not match how you feel, call your healthcare professional.
Alternative site testing may be done: Immediately before a meal Fasting DO NOT test from an alternative site: Two hours or less after eating After exercising If you are sick If you think your blood glucose is low If you often dont notice when your blood glucose is low During peak action time of short-acting insulin or rapid-acting insulin analogues Up to two hours after injecting a short-acting insulin or a rapid-acting insulin analogue
To perform AST, you will need the meter, a test strip, a finger pricker designed for AST, and a lancet.
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1. Prepare the finger pricker by attaching the converter cap and following the standard procedure. 2. Insert the test strip into the meter in the direction of the arrows. The meter turns on automatically.
3. Make sure the code number on the display matches the code number on the test strip container. If you miss the code number on the display, remove the test strip and reinsert it into the meter.
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4. A test strip and flashing blood drop symbol appear on the display.
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5. Press the finger pricker firmly against a fleshy area on the alternative site. Press the finger pricker 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 drop.
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6. Trigger the finger pricker while keeping steady pressure on the site. Apply pressure to the site with the finger pricker 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 a blood sample but do not see the flashing , you may reapply more blood within five seconds. Flag the result or remove and discard the used test strip.
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Troubleshooting Checks
1. Check if the test strips were expired. 2. Check if the cap on the test strip container was always closed tightly. 3. Check if the test strip was out of the container for a long time. 4. Check if the test strips were stored in a cool, dry place.
Action
Discard the test strips if they are past the expiry date. Replace the test strips if you think they were uncapped for some time. Repeat the test with a new test strip. Repeat the test with a properly stored test strip.
Troubleshooting Checks
5. Check if you followed the testing steps.
Action
Read Chapter 2 Testing Your Blood Glucose and test again. If you still have problems, call the Accu-Chek Customer Careline on 0800 701000 (UK) or 1 800 709600 (Ireland). If they do not match, insert the correct code chip into the meter and test again. Repeat the test with a new test strip and run a control test. If you still have problems, call the Accu-Chek Customer Careline on 0800 701000 (UK) or 1 800 709600 (Ireland). 27
6. Check if the code number on the meter display matches the code number on the test strip container. 7. If you are still unsure of the problem
If you are experiencing any of these symptoms, test your blood glucose. If your blood glucose result is displayed as LO or HI, call your healthcare professional immediately.
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. Hold or down to scroll through the results faster. Up to 20 control results are stored in memory, but cannot be reviewed on the meter. The stored control results must first be downloaded to a compatible software application. For product availability, please call the Accu-Chek Customer Careline on 0800 701000 (UK) or 1 800 709600 (Ireland). Control results are not included in the 7, 14, and 30 day averages.
Meter Setup
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. Press and release has three functions for the set-up mode: to enter the set-up mode about four seconds until 31
to set the feature you have chosen. for about four seconds
You can exit the set-up mode at any time by pressing and holding until you see the flashing test strip symbol.
You are here TIME / DATE (hrs, min, day, month, year)
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BEEPER (on/off)
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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.
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decrease
increase
or
decrease
increase
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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.
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You are here TIME / DATE (hrs, min, day, month, year) BEEPER (on/off) ALARM CLOCK (A-1, A-2, A-3, A-4) HYPO ALARM (off, on, level)
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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.
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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.
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You are here TIME / DATE (hrs, min, day, month, year) BEEPER (on/off) ALARM CLOCK (A-1, A-2, A-3, A-4) HYPO ALARM (off, on, level)
Notes:
If you tested within 30 minutes of an alarm, the alarm does not occur. If the meter is on at the alarm time, the alarm does not occur. Exposure to cold conditions may disable alarms until the meter is turned on.
When you are setting the time for the alarm clock function, the bell symbol remains on the display and set-up flashes continuously.
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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 bell symbol, OFF, and the flashing set-up and A-1.
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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.
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7. The minutes flash. Press and release or to select 00, 15, 30, or 45. These are the only choices.
to
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.
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You are here TIME / DATE (hrs, min, day, month, year) BEEPER (on/off) ALARM CLOCK (A-1, A-2, A-3, A-4) HYPO ALARM (off, on, level)
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1. Press to turn the meter on. The flashing test strip symbol appears.
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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 .
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4. Press and release or to switch between On and OFF. Press and release to set your choice.
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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.
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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. Make sure the software is ready to accept data from the meter. 3. With the meter off, press and hold both arrows on the display alternately flash. and until two 45
4. Locate the infrared (IR) window on the top of the meter. 5. Locate the IR window on either the infrared cable (computer) or PDA.
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Notes:
If the data did not transfer successfully, try again. If you still have problems, call the Accu-Chek Customer Careline on 0800 701000 (UK) or 1 800 709600 (Ireland). To make the most of the download feature, you must set the time and date in the meter correctly. To find out more about downloading your results and what tools are available, call the Accu-Chek Customer Careline on 0800 701000 (UK) or 1 800 709600 (Ireland).
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1. Insert the test strip into the meter in the direction of the arrows. The meter turns on automatically.
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.
OR
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3. Select the control solution you want to test. You will enter the level later in the test.
5. Remove the control bottle cap. Wipe the tip of the bottle with a tissue.
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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.
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8. Press meter.
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.
Level 1 Level 2
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 resolve the problem:
Troubleshooting Checks
1. Check if the test strip or control solutions were expired.
Action
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. Wipe the tip of the bottle with a tissue. Repeat the control test with a new test strip and a fresh drop of control solution. Replace the test strips or control solutions if you think either was uncapped for some time. Repeat the control test with a new test strip. Repeat the control test with a properly stored test strip or control solution.
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2. Check if you wiped the tip of the control solution bottle before and after use. 3. Check if the caps on the test strip container and the control solution bottle were always closed tightly. 4. Check if the test strip was out of the container for a long time. 5. Check if the test strips and control solutions were stored in a cool, dry place.
Troubleshooting Checks
6. Check if you followed the testing steps.
Action
Read Chapter 4 Control Testing and test again. If you still have problems, call the Accu-Chek Customer Careline on 0800 701000 (UK) or 1 800 709600 (Ireland). If you chose the wrong control solution level, you can still compare the control result to the range printed on the test strip container. If they do not match, insert the correct code chip into the meter and test again. Repeat the control test with a new test strip. If you still have problems, call the Accu-Chek Customer Careline on 0800 701000 (UK) or 1 800 709600 (Ireland).
7. Check if you chose the correct control solution level, either 1 or 2, when you performed the test. 8. Check if the code number on the meter display matches the code number on the test strip container. 9. If you are still unsure of the problem
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Patients and healthcare workers are potentially at risk of becoming infected when the same blood glucose meter is used to test blood glucose in more than one patient. Any patient with an infection or suffering from an infectious disease and any patient who is a carrier of a multi-resistant organism must be assigned his/her own meter. This also applies if a patient is suspected of being one of the above and, for as long as the suspicion exists, the meter must not be used to test any other patient. The Accu-Chek Multiclix Finger Pricker is intended for patient self-monitoring by a single person only. It must not be used to collect blood from more than one person as this poses an infection risk. Any object coming into contact with human blood is a potential source of infection (see: Clinical and Laboratory Standards Institute: Protection of Laboratory Workers from Occupationally Acquired Infections; Approved Guideline Third Edition; CLSI document M29-A3, 2005). 57
Note:
The hypo level may vary from person to person. Therefore we recommend leaving the hypo alarm function turned off when using the meter in a professional setting.
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7. Make sure the code number on the meter display matches the code number on the test strip container. 8. Lance the side of the fingertip. 9. Using gentle pressure, massage the finger towards the fingertip to encourage a drop of blood to form. A proper but nevertheless small drop of blood (approx. 0.6 L) must form.
10. Immediately after the drop of blood has formed, touch the drop to the front edge of the yellow window of the test strip (do not put blood on top of the test strip). 11. The test strip draws up blood.
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60 12. 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, if applied IMMEDIATELY. 13. The result appears on the display. 14. Remove and discard the used test strip.
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Notes:
To test blood glucose approximately 0.6 L of blood is required. Avoid producing large drops of blood on the patients finger. Where the drops of blood are too large, the meter may come into contact with the blood. Wipe off any large drops of blood. Test using the drop of blood that forms again at the puncture site. Residues of water or disinfectant on the skin can dilute the drop of blood producing false results. After a successful test the meter turns itself off 5 seconds after the test strip is removed. Dispose of used lancets, test strips or single-use lancing devices according to local health and safety regulations. The test strip cannot properly draw up blood that has spread over the skin. 61
What to Disinfect
In the unlikely event that the meter becomes contaminated, the following parts of the meter may be disinfected: The area around the test strip slot The display screen The outer casing
How to Disinfect
62 Make sure the meter is off. Gently wipe the meters surface. Cotton buds, wipes and cloths lightly moistened with disinfectant are all suitable for disinfecting the meter. Allow areas you have wiped time to dry thoroughly. Remove any fluff or lint that may remain. Refer to the section Cleaning the Meter for further information.
Notes:
Make sure that no liquid enters the meter. Do not spray anything onto the meter and do not immerse it in liquid. Doing so may damage the meters internal components and stop it from working properly.
When to Disinfect
Each time after you have tested a patients blood glucose: wipe the area around the test strip slot. If you find blood on the cloth, also wipe the test strip slot itself and the display. If there is blood on the meter: wipe the meter. If blood has entered the meter: wipe the area around the test strip slot and the display screen. Allow areas you have wiped time to dry thoroughly. The meter, including the test strip slot and display screen, must be thoroughly cleaned and disinfected at least once a day after use. Carefully check all recesses, grooves and gaps.
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64 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 available. Be sure the battery goes in + side up or facing you. After you change the battery, the meter prompts you to confirm the meters time and date settings. See Chapter 1 Adjusting the Time and Date. All test results are saved in memory.
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Do
Make sure the meter is off Gently wipe the meters surface with a soft cloth slightly dampened (wring out any excess liquid) with one of these cleaning solutions: Super Sani-Cloth 70% isopropyl alcohol 66 Mild washing up liquid mixed with water 10% household bleach solution (1 part bleach plus 9 parts water) made the same day
Do Not
Get any moisture in the code chip slot or test strip slot Spray any cleaning solution directly onto the meter Put the meter under water or liquid Pour liquid into the meter
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Never make treatment decisions based on an error message. If you have any concerns, call the Accu-Chek Customer Careline on 0800 701000 (UK) or 1 800 709600 (Ireland). The meter will not turn on or the display is blank. Battery is dead Insert new battery Display is damaged Call the Accu-Chek Customer Careline on 0800 701000 (UK) or 1 800 709600 (Ireland). Meter is defective Call the Accu-Chek Customer Careline on 0800 701000 (UK) or 1 800 709600 (Ireland). Extreme temperatures Move the meter to a more temperate area
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Battery power is low. Change the battery soon. See Chapter 6 Changing the Battery.
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The meter is in set-up mode, waiting for you to change or confirm settings. See Chapter 3 Meter Setup.
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Blood glucose may be higher than the measuring range of the system.
The test result was flagged. See Chapter 2 Flagging Test Results.
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Blood glucose may be lower than the measuring range of the system.
Blood glucose is below the defined hypo (low blood glucose) level.
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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.
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Note:
If you see any other error screen, please call the Accu-Chek Customer Careline on 0800 701000 (UK) or 1 800 709600 (Ireland).
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Your blood glucose 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 the Accu-Chek Customer Careline on 0800 701000 (UK) or 1 800 709600 (Ireland).
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The code chip is incorrect. Turn the meter off and insert a new code chip. If this does not fix the problem, call the Accu-Chek Customer Careline on 0800 701000 (UK) or 1 800 709600 (Ireland). An error occurred during the test. Discard the test strip and repeat the test. See Chapter 1 Understanding Your New System.
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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.
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Blood or control solution was applied to the test strip before the flashing blood drop symbol appeared on the display. Discard the test strip and repeat the test. An electronic error occurred, or, in rare cases, a used test strip was removed and reinserted. Turn the meter off and on, or take the battery out for 10 seconds and reinsert it. Perform a blood glucose 73 or control test. If the problem persists, call the Accu-Chek Customer Careline on 0800 701000 (UK) or 1 800 709600 (Ireland).
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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.
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The temperature is above or below the proper range for the meter (6C to 44C). Move to an area between 6C and 44C, wait five minutes and repeat the test. Do not artificially heat or cool the meter.
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.
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The battery is almost out of power. Change the battery now. See Chapter 6 Changing the Battery.
Specifications
Blood volume Sample type Measuring time Measuring range Test strip storage conditions Meter storage conditions System operating conditions Memory capacity Automatic power off Power supply Display Dimensions
0.6 L Fresh capillary whole blood 5 seconds 0.6 to 33.3 mmol/L 2C to 32C Temperature: -25C to 70C 6C to 44C 10% to 90% relative humidity 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)
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Weight Construction Protection class Meter type Control solution storage conditions
Approx. 60 g (with battery) Hand-held III The Accu-Chek Aviva Meter is suitable for continuous operation 2C to 32C
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Electromagnetic Compatibility This meter meets the electromagnetic immunity requirements as per EN ISO 15197 Annex A. The chosen basis for electrostatic discharge immunity testing was basic standard IEC 61000-4-2. In addition, it meets the electromagnetic emissions requirements as per EN 61326. Its electromagnetic emission is thus low. Interference from other electrically driven equipment is not to be anticipated. 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. For method comparison, the results were compared with results obtained using the hexokinase method with deproteinization (automatic analyzer). The hexokinase method is traceable to an NIST standard. The Accu-Chek Aviva System meets the EN ISO 15197 requirements. Measuring Principle Blood glucose concentrations may be measured in whole blood or plasma. Although you always apply whole blood to the test strip, the meter displays blood glucose results that relate either to whole blood or plasma. To see whether your blood glucose meter displays results relating to whole blood or plasma, see the package insert that came with your test strips. You will also find information on how the system works, on the test principle and on reference methods.
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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.
Explanation of Symbols
On packaging, on the type plate, 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 Underwriters Laboratories, Inc. in accordance with UL 61010A-1 and CAN/CSA C22.2 No.1010-1. For in vitro diagnostic use This product fulfills the requirements of Directive 98/79/EC on in vitro diagnostic medical devices Dispose in domestic waste 3V type 2032
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STERILE R
Sterilized using irradiation (with at least 25 kGy) This product fulfills the requirements of Directive 93/42/EEC on medical devices
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If you have a claim under this guarantee, please return the Accu-Chek Multiclix Finger Pricker and the original sales receipt to: Customer Services Department, Roche Diagnostics Limited Charles Avenue Burgess Hill West Sussex RH15 9RY Guarantee: The statutory provisions on rights in consumer goods sales in the country of purchase shall apply.
Additional Supplies
Test strips are available from your local Pharmacist only and the control solutions can be obtained via the Accu-Chek Customer Careline only.
Test Strips
Accu-Chek Aviva Test Strips
Control Solutions
Accu-Chek Aviva Control Solutions
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Lancet Drums
Accu-Chek Multiclix Lancet Drums
Healthcare Professionals: Follow the infection control procedures appropriate for your facility.
References
1. Stedman, TL, Stedmans Medical Dictionary, Medical Dictionary, 27th Edition, 1999, p. 2082.
Depth Indicator
Finger Pricker
Priming Button
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The Accu-Chek Multiclix Finger Pricker is intended for patient self-monitoring by a single person only. It must not be used to collect blood from more than one person as this poses an infection risk. Any object coming into contact with human blood is a potential source of infection (see: Clinical and Laboratory Standards Institute: Protection of Laboratory Workers from Occupationally Acquired Infections; Approved Guideline Third Edition; CLSI document M29-A3, 2005). The blue cap is for fingertip testing only. The AST converter cap is for testing alternative sites on the body, not the fingertip.
A used drum has two visible red stripes and the blue ring can rotate on the white drum. You cannot insert a used drum into the finger pricker.
1. Place your thumb to the side of the notch and remove the cap by pulling it straight off. It is not a twist cap. 85
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2. Make sure the release button is not yellow. Insert a new drum, blue ring first, until it clicks into place.
3. Align the notch on the cap with the notch on the device and slide the cap on until it stops.
4. You are now ready to use the first lancet. The lancet counter shows five white bars, meaning you have five new lancets remaining.
5. The depth indicator shows the current depth selection. The higher the number, the deeper the penetration. Twist the comfort dial to adjust the setting. Start at 2 or 3 for soft skin. Try a higher setting if your skin is calloused or thick.
6. Press the priming button like a pen until it clicks. The release button turns yellow. Do not press the release button while pressing the priming button. 87
1. Wash and dry your hands. 2. Press the finger pricker firmly against the side of your fingertip and press the yellow release button. 88
3. Load the next lancet by twisting the plunger one-quarter turn forward (until it stops), then back again. The lancet counter decreases by one white bar. For safety reasons, once you advance to a new lancet, you cannot go back to a used lancet.
1. Place your thumb to the side of the notch and remove the cap by pulling it straight off. It is not a twist cap.
2. Align the notch on the converter cap with the notch on the finger pricker and slide the cap on until it stops.
3. Dial the depth setting to 5 1/2 for forearm, upper arm, thigh, or calf testing. Dial the depth setting to 3 for palm testing.
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4. Press the priming button like a pen until it clicks. The release button turns yellow. Do not press the release button while pressing the priming button. 90
5. Press the finger pricker firmly against a fleshy site and press the yellow release button. Immediately lift the finger pricker off the site. Remove the converter cap by pulling it straight off.
Note:
Once you run a successful test, you may want to find the lowest depth setting that provided enough blood with the least amount of pain.
6. Return the converter cap to the same position over the puncture site. Apply pressure to the site to help the blood drop form properly. Do not allow the cap to touch the blood drop.
7. Load the next lancet by twisting the plunger one-quarter turn forward (until it stops), then back again. The lancet counter decreases by one white bar. For safety reasons, once you advance to a new lancet, you cannot go back to a used lancet.
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thenar
IMPORTANT
Talk to your healthcare professional about Alternative Site Testing.
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Do not change your treatment because of just one result. NEVER ignore symptoms of high or low blood glucose. If your blood glucose 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, call your healthcare professional.
Alternative site testing may be done: Immediately before a meal Fasting DO NOT test from an alternative site: Two hours or less after eating After exercising If you are sick If you think your blood glucose is low If you often dont notice when your blood glucose is low During peak action time of short-acting insulin or rapid-acting insulin analogues Up to two hours after injecting a short-acting insulin or a rapid-acting insulin analogue
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Notes:
A used drum cannot be reinserted into the finger pricker. In rare instances, if a used drum is dropped on a hard surface the lancets may protrude slightly from the drum. If you drop a drum, always pick it up at the red-striped end.
1. Place your thumb to the side of the notch and remove the cap by pulling it straight off. It is not a twist cap.
2. Hold the drum between your thumb and index finger and pull it straight out of the finger pricker. Two red stripes are visible on the white part, indicating that the drum has been used.
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Index
alarm clock function, setting, 38 alternative site testing, (AST), 21, 82, 92 appetite, increased, 28 battery, changing, 64 battery, installing, 64 battery, type, 65, 75, 78 beeper, setting, 35 blood glucose, testing, 15 blurred vision, 28 button, on/off/set, 8 code chip, 9, 10 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, 67 disposing of the meter, 77 error messages, 6874 expiry date, 14, 48 fatigue, 28 flagging test results, 20 frequent urination, 28 high blood glucose, 28 hyperglycemia, 28 hypoglycemia, 28
hypoglycemic alarm function, setting, 42 low blood glucose, 28 maintenance, meter, 64 memory, meter, 29 numbness, 28 product limitations, 75 product specifications, 75 professional caregivers, 82 rapid heartbeat, 28 settings, meter, 31 supplies, 81 sweating, 28 symbols, 7879 technical information, 75 test results, unusual, 26 test strips, Accu-Chek Aviva, 9, 14
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thirst, increased, 28 time and date, setting, 32 tingling, 28 trembling, 28 troubleshooting, 6874 warranty, 80
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Any Questions?
We want to give you the help you need for long and reliable service of your meter. Review your test procedure and make sure that you are performing the steps correctly. If you still have questions, please call the Accu-Chek Customer Careline on 0800 701000 (UK) or 1 800 709600 (Ireland). Please have your Accu-Chek Aviva Meter, Accu-Chek Aviva Test Strips, and Accu-Chek Aviva Control Solutions available when you call. IMPORTANT READ CAREFULLY BEFORE USE GUARANTEE: The statutory provisions on rights in consumer goods sales in the country of purchase shall apply. Roche Diagnostics Limited Charles Avenue Burgess Hill West Sussex RH15 9RY +44 (0) 1444 256000 Accu-Chek Customer Careline* 0800 701 000 (UK) 1 800 709 600 (Ireland) *Calls may be recorded for training purposes 99
The Accu-Chek Aviva System, including the meter, code chip, and test strips, is covered by the following patents: British Patent Nos. 0 505 504 and 2187191, and European Patent No. 0 505 504. British Patent No. 2187191 is licensed from Quadrant Holdings Cambridge Limited. The Accu-Chek Multiclix Finger Pricker is covered by the following patents: European Patent Nos. 1 034 740, 0 565 970, and 0 782 838.
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ACCU-CHEK Aviva
2008 Roche Diagnostics. All rights reserved. 04886046001(02)-0907 Roche Diagnostics GmbH, 68298 Mannheim, Germany www.accu-chek.com ACCU-CHEK, ACCU-CHEK MULTICLIX, and ACCU-CHEK AVIVA are trademarks of Roche. All other product names and trademarks are the property of their respective owners.