accu-check aviva meter owners booklet

BLOOD GLUCOSE METER

Owner’s Booklet

Dear ACCU-CHEK ® System Owner,Thank you for choosing the ACCU-CHEK Aviva system!

Congratulations on your decision to take control of your diabetes. We’ve designed your new ACCU-CHEK Avivasystem with comfort, convenience, and control in mind—to help make living with diabetes a little easier.

This booklet will help you get the most from your ACCU-CHEK Aviva system.

To start testing quickly, you can also refer to the First Time Guide.

If you have questions, we’re here to help. Just call the ACCU-CHEK Customer Care Service Center toll-free at1-800-858-8072. We offer assistance 24 hours a day, 365 days a year in many languages. You can also visitwww.accu-chek.com for diabetes management tools and product demonstrations.

Thanks again for choosing the ACCU-CHEK Aviva system.

The ACCU-CHEK® Aviva SystemYour new ACCU-CHEK Aviva meter and accessories work together to measure the amount of sugar (glucose) inyour blood. The system is designed for monitoring blood glucose in the home or healthcare facility by personswith diabetes or by healthcare professionals. The device is intended for professional use and over-the-countersale. When you put a small drop of blood onto the test strip, the meter displays a blood sugar result in fiveseconds. You can take a blood drop from your fingertip, palm, forearm, upper arm, calf, or thigh. We’ve made itas simple as possible. Your meter is easy to use, plus you can adjust the lancet device for your comfort.The system includes:

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• ACCU-CHEK Aviva meter with battery• ACCU-CHEK Aviva test strips and code key* • ACCU-CHEK Aviva control solution*

• ACCU-CHEK Multiclix lancet device* (with a blue cap for fingertip testing and a clearcap for non-fingertip testing)

• ACCU-CHEK Multiclix lancet drum*

Why Regular Blood Sugar Testing Is ImportantTesting your blood sugar regularly can make a big difference in how you manage your diabetes every day.Discussing your results with your doctors and following their advice about medicine, exercise, and food planscan help you better control your diabetes.

*may be sold separately

Need Help?If you have questions, we’re here to help. Just call the ACCU-CHEK Customer Care Service Center toll-free at1-800-858-8072. We offer assistance 24 hours a day, 365 days a year in many languages. You can also visitwww.accu-chek.com for diabetes management tools and product demonstrations.

Please complete your Warranty Card and mail it, so you receive the best customer service possible andproduct update news.

Before You Start TestingAbout the meter and test strips• Carefully read and follow the instructions in the Owner’s Booklet and Package Inserts for the test strips and

control solutions. Not following the instructions may lead to a wrong result or improper treatment, causingyou health problems.

• Set the time and date on your meter before you begin testing.

• Your new meter is designed and can be used for testing fresh capillary whole blood samples (for example,blood from your fingertip or forearm). Use only ACCU-CHEK Aviva test strips.

• Although you always apply whole blood to the test strip, your system has been calibrated to deliverplasma-like values for easier comparison to lab results.

• Inspect the container of test strips before using them for the first time. If you see any damage to thecontainer cap or if anything prevents the cap from closing properly, do not use the test strips. Contact theACCU-CHEK Customer Care Service Center. Damaged test strips can cause inaccurate results, which couldlead to improper treatment.

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• The meter, test strips, and control solutions are only for use outside the body (in vitro). Do not eat the teststrips. Do not swallow or inject control solutions, or use control solutions for any purpose other than testingthe ACCU-CHEK Aviva system.

• The ACCU-CHEK Aviva system has been found to be accurate at altitudes up to 10,150 feet.

• Refer to your Test Strip and Control Solution Package Inserts for additional health-related information.

• It is always a good idea to have a back-up testing method available. Examples of back-up testing methodsinclude a back-up meter or testing by a lab. Ask your doctor or pharmacist about other possible back-upmethods.

About testing yourself or others• Certain substances can interfere with the ACCU-CHEK Aviva blood glucose system and cause falsely high

results. For example, peritoneal dialysis solutions containing icodextrin (such as Extraneal) or certainimmunoglobulin therapies that contain maltose (such as Octagam® 5%), cause inaccurate results. For moreinformation, refer to the Test Strip Package Insert, or ask your doctor.

• If you are very dehydrated or urinating frequently, you may get an inaccurate test result. If you think you aredehydrated, call your doctor right away.

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• Some people with diabetes do not experience symptoms of low blood sugar (hypoglycemia). Others, suchas children or people who are unconscious or have certain disabilities, may not be able to communicatetheir symptoms to caregivers. For these reasons, do not change any treatment without first talking to adoctor.

• Run a control test when you open a new box of test strips or if you think that your test result is incorrect.Running a control test lets you know that the meter and test strips are working properly.

DO NOT CHANGE YOUR TREATMENT BASED ON A SINGLE RESULT THAT DOES NOT MATCH HOW YOU FEELOR IF YOU BELIEVE THAT YOUR TEST RESULT COULD BE INCORRECT.

If your blood sugar result doesn’t match how you feel and you have followed the instructions in thisOwner’s Booklet, follow your doctor’s instructions, or call your doctor.

Special Information for Healthcare Providers and Caregivers• Do not use this device to measure blood sugar in people who are experiencing cardiovascular collapse

(severe shock) or decreased peripheral blood flow.

• Children should be taught how to use the meter and any other medical products appropriately.

ContentsChapter 1: Understanding Your New System ................................................................................8

The ACCU-CHEK Aviva Meter .....................................................................................................8Coding Your Meter ...................................................................................................................10Adjusting the Time and Date—First Time Use..........................................................................12Using ACCU-CHEK Aviva Test Strips .........................................................................................14

Chapter 2: Control Testing ...........................................................................................................16Why Run Control Tests .............................................................................................................16About the Control Solutions......................................................................................................16Running a Control Test.............................................................................................................17Understanding Control Test Results..........................................................................................21

Chapter 3: Testing Your Blood Sugar ..........................................................................................24Using the ACCU-CHEK Multiclix Lancet Device .........................................................................24Inserting a Lancet Drum ..........................................................................................................25Preparing the Lancet Device for Fingertip Testing ....................................................................27Running a Blood Sugar Test with Blood from Your Fingertip .....................................................29Changing the Lancet Drum ......................................................................................................33Running a Blood Sugar Test with Blood from Your Palm, Forearm, Upper Arm, Thigh, or Calf..........35Flagging Test Results ...............................................................................................................44Understanding Test Results......................................................................................................45Comparing Your Meter Result to a Lab Result ..........................................................................47Chapter 4: Meter Memory, Setup, and Downloading ...........................................................48Memory ...................................................................................................................................48

Contents 6

Contents 7

Meter Setup.............................................................................................................................50Setting the Time and Date .......................................................................................................51Setting the Beeper On/Off ........................................................................................................54Setting Test Reminders ............................................................................................................57Setting the Hypoglycemic (Hypo) Indicator ...............................................................................61Downloading Your Results to a Computer.................................................................................64

Chapter 5: Maintenance and Troubleshooting ............................................................................66Changing the Battery ...............................................................................................................66Cleaning Your Meter.................................................................................................................67Maintenance and Testing .........................................................................................................68Cleaning Your Lancet Device....................................................................................................68Screen Messages and Troubleshooting ....................................................................................69

Chapter 6: Technical Information ................................................................................................74Product Limitations..................................................................................................................74Specifications ..........................................................................................................................74Product Safety Information ......................................................................................................76Travel Documentation ..............................................................................................................77Disposing of the Meter.............................................................................................................77Warranty..................................................................................................................................78Limited License .......................................................................................................................80Additional Supplies ..................................................................................................................82Information for Healthcare Professionals..................................................................................83References ..............................................................................................................................84Index .......................................................................................................................................85

Chapter 1: Understanding Your New System*The ACCU-CHEK Aviva Meter

Display –Shows results,messages, andresults stored inmemory.

Right and LeftArrow Buttons –Press to viewmemory, adjustsettings, and scrollthrough results.

Test Strip Slot –Insert test striphere.

Infrared (IR) Window –Used to transfer datafrom the meter to acomputer.

On/Off/Set Button –Turns the meter on or off and sets options.

Battery Door – Flip open the batterydoor by pushing the tab in the direction of the arrow.

Code Key Slot –Insert code keyinto this opening.

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Code Key(for example)

Battery – Insertwith (+) symbolfacing up.

Chapter 1: Your New Meter 9

Test Strip Container Top View

On/Off/SetButton

Infrared (IR) Window

YellowWindow –Touch blooddrop or controlsolution here.

Comfort Dial with Depth Selection

Cap

Lancet Device

Release Button

Plunger

LancetDrum

Clear Cap(for obtaining blood from sites

other than your fingertip)

Test Strip

Golden End –Insert this endof the test stripinto the meter.

Control Solution Bottle

*Some items may be sold separately.

Lancet Counter

Depth Indicator

Chapter 1: Understanding Your New System 10

▲!

Coding Your MeterA new code key is inside each new box of test strips.

1. Make sure your meter is off. 2. Turn the meter over. 3. Remove the old code key (if there is one in the meter)and throw it away.

Change the code key every time you open a new box of test strips!


Notes:• Don’t force the code key into the meter — it is made to go into the meter only one way.• If you see “code” and “- - -” on the display, turn the meter off and reinsert a code key into the meter.

4. Turn the code key over so the code numberfaces away from you. Push it into the meteruntil it stops.

5. Leave the code key in the meter until youopen a new box of test strips. Remember tochange the code key each time you open anew box of test strips.

▲! Be sure the code key matches the code number on the test strip container. If they don’tmatch, you could get inaccurate results.


1. Press and release to turn themeter on. The time and dateappear on the display. “Set” andthe hour flash. If this is thecorrect time and date, press andhold to exit the set mode.

2. Press and release or todecrease or increase the hour.Press and hold or toscroll faster.

3. Press and release to set the hour. The minutes flash.

Adjusting the Time and Date—First Time UseYour new meter comes with a preset time and date. You may need to change the time to your time zone.Having the right time and date in your meter is important if you use the meter memory or if you want todownload your results to a computer. It also helps your healthcare team interpret your results.

decrease increase

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4. Repeat steps 2 and 3 to set theminutes, am/pm, month, day,and year. The flashing field isthe one you are changing.

5. Once you set the year, pressand hold until the flashingtest strip symbol appears.

6. See Chapter 4 “Meter Setup” toset other options.

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Note: When you install a new battery, the meter automatically prompts you to check the time and datewhen you turn it on. If it is correct, press and hold to exit the set mode.

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Using ACCU-CHEK Aviva Test Strips• Only use ACCU-CHEK Aviva test strips.

• Replace the code key and run a control test every time you open a new box of test strips.(See Chapter 2 “Control Testing.”)

• Keep the test strips in their original container. Donot remove test strips from the test strip containerand put them into another container, such as aplastic bag, pocket, purse, wallet, etc.

• Close the container tightly right after you take atest strip out. This helps keep the test strips dry.

• Be sure to check the “Use by” date on the teststrip container. Do not use the test strips after thatdate. If the “Use by” date is missing or cannot beread, do not use the test strips.

• Use the test strip within three minutes after youtake it out of the container.

• Store the test strips at 36 to 90°F. Do notrefrigerate, freeze, or expose strips to heat,moisture, or humidity. Temperatures outside therequired range, as well as moisture and humidity,can damage your test strips and lead toinaccurate results.

• Do not apply blood or control solution to the teststrip before you insert it into the meter. If themeter gives you a result before applying blood orcontrol solution, do not act on that result.

• Do not reuse test strips. Once you have put controlsolution or blood on a test strip, throw it away. Ifyou need to retest, use a new test strip.


▲!DO NOT• Store test strips in extreme temperatures or moisture areas (bathroom, kitchen, laundry

room, car, or garage). Heat and moisture can damage your test strips.• Bend, cut, or alter the test strips.• Get dirt, food, or other material on the test strip.Not following these precautions can lead to inaccurate results.


Chapter 2: Control TestingWhy Run Control TestsRunning a control test lets you know that your meter and test strips are working properly.You should run a control test when:• You open a new box of test strips

• You left the test strip container open or you thinkyour test strips have been damaged

• Your test strips were stored in extremetemperatures or humidity

• You want to check the meter and test strips

• You dropped the meter

• Your test result doesn’t agree with how you feel

• You want to check if you are testing correctly

About the Control Solutions• Only use ACCU-CHEK Aviva control solutions.

• Your meter is designed to recognize the differencebetween a control solution and blood.

• Write the date you open the bottle on the bottlelabel. The control solution is good for three monthsfrom the date the bottle was opened (discard date)or until the “Use by” date on the bottle label,whichever comes first.

• Do not use control solution that is past the “Use by” or discard date.

• The control solution can stain clothing. If you spillit, wash your clothes with soap and water.

• The control solution results are not displayed inmemory.

• Close the bottle tightly after use.

• Store the bottle at 36 to 90°F. Do not freeze.

Chapter 2: Control Testing 17

Running a Control TestYou need the meter, a test strip, and control solution Level 1 or Level 2.The control level is printed on the bottle label.

1. Put a test strip into themeter in the direction ofthe arrow. The meterturns on.

Note: Most people just test the Level 1 control. If you wish,you can also test a Level 2 control. A set of Level 1and Level 2 control solutions is available forpurchase. To order control solutions, talk to yourpharmacist or visit www.accu-chek.com to orderonline. Your meter is designed to recognize thedifference between a control solution and blood. Thecontrol solution results are not displayed in memory.


2. Make sure the code number onthe display matches the codenumber on the test stripcontainer. If you miss seeing thecode number, take the test stripout and reinsert it into the meter.

3. Select the control solution youwant to test. You will enter thelevel later in the test.

4. Place the meter on a flatsurface, like a table.

5. Remove the control bottle capand wipe the tip of the bottlewith a tissue.

OR

Running a Control Test (continued)


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6. Squeeze the bottle until a tiny drop forms at thetip of the bottle. Touch the drop to the tip of theyellow window of the test strip. Do not putcontrol solution on top of the test strip. Whenyou see flash, you have enough controlsolution in the test strip. Wipe the tip of the bottlewith a tissue then cap the bottle tightly.

7. A result appears on the display, along with acontrol bottle symbol and a flashing “L.” Don’tremove the test strip yet. Press once tomark it as a Level 1. If you tested the Level 2control, press a second time.


in rangeexample

out of rangeexample

Running a Control Test (continued)

8. Press to set the level in the meter. 9. The control result and “OK” alternate on thedisplay if the result is in range. The range isprinted on the test strip container label. Thecontrol result and “Err” alternate on the display ifthe result is out of range. Remove the used teststrip and throw it away.


Understanding Control Test Results

Example

The label on your test strip container shows the acceptableranges for both the Level 1 and the Level 2 control solutions.The result you get should be inside this range. Make sure youcompare the result to the correct level of control.

When the control result is inside the range on the test stripcontainer, your test strips and meter are working properly.

Range (mg/dL)Level 1 25–55Level 2 255–345

(This is an example. Refer to the rangeson your test strip container.)

▲!The control ranges apply only to control results.They only indicate that your test strips and meterare working properly. Do not use control results tointerpret blood sugar results.

If your control result is not inside the acceptable range (printed on your test strip container), do not use yourmeter until you solve the problem. Here are some things you can check:

Troubleshooting Checks1. Are the test strips or control solution past

the “Use by” or discard date?

2. Did you wipe the tip of the control solutionbottle with a tissue before and after use?

3. Were the test strip container and controlsolution bottle always closed tightly?

4. Was the test strip out of the container formore than three minutes?

5. Were your test strips and control solutionstored in a cool, dry place?

ActionIf either is past the “Use by” or discard date, throwit away.

Wipe the tip of the bottle with a tissue. Repeat thecontrol test with a new test strip and a fresh dropof control solution.

If you think either may have been uncapped forsome time, replace the test strips or controlsolution.

Repeat the control test with a new test strip.

Repeat the control test with properly stored teststrips or control solutions.



Troubleshooting Checks6. Did you follow all of the testing instructions?

7. Did you choose the correct control solutionlevel, either 1 or 2, when you ran the test?

8. Does the code number on the meter displaymatch the code number on the test stripcontainer?

9. If you are still unsure of the problem…

ActionRead Chapter 2 “Control Testing” and test again.If you still have problems, call the ACCU-CHEKCustomer Care Service Center at 1-800-858-8072.

If you chose the wrong control solution level, youcan still compare the control result to the rangeprinted on the test strip container.

If they don’t match, insert the correct code key inthe meter and test again.

Repeat the control test with a new test strip. Ifyou still have problems, call the ACCU-CHEKCustomer Care Service Center at 1-800-858-8072.

Chapter 3: Testing Your Blood Sugar 24

Chapter 3: Testing Your Blood SugarUsing the ACCU-CHEK Multiclix Lancet Device

Notes:• Testing with blood from sites other than your fingertip

requires the clear cap. This is explained later in thechapter.

• To reduce the risk of infection, never share your lancetdevice with anyone.

• Always use a new lancet with each test.

• The best depth setting is the lowest number that letsyou get enough blood for a test. Try different settings tofind the one that’s right for you. For virtually pain-freetesting, always use a new lancet for every test. With the ACCU-CHEK Multiclix lancet device, you simply change the lancet with a twist.

The clear cap is fortesting other approvedsites on the body, not thefingertip.

The blue cap is forfingertip testing only.

A new drum has a bluering that does not move.

A used drum has two visible redstripes and the blue ring can rotateon the white drum. You cannot inserta used drum into the lancet device.


Inserting a Lancet DrumYou must first load the drum into the lancet device to get it ready for use.

1. Remove the cap by pulling it straight off. It is not atwist cap. The easiest way to do this is to placeyour thumb to the side of the notch as seen in theillustration.

2. Before you insert a drum, be sure that the releasebutton is not yellow, and that no lancets aresticking out of the drum. Insert a new drum, bluering first, until it stops. It clicks into place.


3. Slide the cap on until it stops by aligning thenotch on the cap with the notch on the device.

4. You are now ready to use the first lancet. Thelancet counter on the plunger shows five whitebars, meaning you have five new lancetsremaining.

Inserting a Lancet Drum (continued)


Preparing the Lancet Device for Fingertip Testing

▲! Use a new lancet for each fingerstick to avoid infection and get a virtually pain-free test.

1. Make sure the blue cap is on the lancet device.Do not use the clear cap to do a fingertip test.

2. Adjust the depth by turning the Comfort Dial.The depth indicator shows the current depthselection. The higher the number, the deeper thepenetration. If you have soft skin, we suggeststarting at a depth of 2. If your skin is calloused orthick, try a higher setting.


3. Press the plunger in as far as it will go, like a pen. 4. The release button turns yellow. Do not press therelease button while pressing the plunger. Set thelancet device aside until later in the test.

Preparing the Lancet Device for Fingertip Testing (continued)


Running a Blood Sugar Test with Blood from Your FingertipBefore you run your first blood test, set up your meter correctly and run a control test.You need the meter, a test strip, and a lancet device with a drum loaded to run a blood test.

1. Wash your hands with warmsoapy water and dry. Dirty handscould affect results.

2. Put a test strip into the meter inthe direction of the arrow. Themeter turns on.

3. Make sure the code number onthe display matches the codenumber on the test stripcontainer. If you miss seeing thecode number, remove the teststrip and reinsert it into themeter.

4. When the blood drop symbolflashes, obtain a drop of blood fromyour fingertip.

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Running a Blood Sugar Test with Blood from Your Fingertip (continued)


5. Hold the lancet device firmly against the side of yourfingertip. Remember that the opening where thelancet comes out is not in the center of the cap. Pressthe yellow release button. Make sure that each lancetis fully retracted after use.

6. Gently squeeze your finger to assist the flow ofblood. This helps you get a blood drop. Touch thedrop to the tip of the yellow window of the teststrip. Do not put blood on top of the test strip.

Note: The meter turns itself off five seconds after the test strip is removed.

Yellow releasebutton


Note: Do not twist the plunger when the release button is yellow or when the lancet counter shows nowhite bars. This may damage the device.

7. When you see flash, you have enough bloodin the test strip. If you applied blood but do notsee the flashing you may reapply more bloodwithin five seconds.

8. Your result appears on the display. If you want toflag your test result for a special event, leave thetest strip in the meter. (See “Flagging TestResults.”) Otherwise, throw the used test stripaway.


9. For virtually pain-free testing, we recommend thatyou advance to a new, sterile lancet after eachtest. To load the next lancet, twist the plunger one-quarter turn forward (until it stops), then twist itback all the way.

10. The lancet counter decreases by one white bar.For safety reasons, once you advance to a newlancet, you cannot go back to a used lancet.

Running a Blood Sugar Test with Blood from Your Fingertip (continued)


Changing the Lancet DrumWhen you have used the sixth and last lancet, you should change the drum.

1. Take the blue cap off the lancet device bypulling it straight off. It is not a twist cap. Theeasiest way to do this is to place your thumb tothe side of the notch as seen in the illustration.

2. Hold the drum between your thumb and indexfinger and pull it straight out of the lancetdevice. Two red stripes are visible on the whitepart, indicating that the drum has been used.

OR


Notes: • A used drum cannot be reinserted into the lancet device.• If the ACCU-CHEK Multiclix lancet device or drum is dropped on a hard surface, the lancets may stick out

slightly from the drum and could cause injury. If you drop a drum, always pick it up at the red striped endand dispose in a sharps container.

3. Throw the old drum away. A non-damageddrum may be disposed of in a common wastecontainer.

4. Before you insert a drum, be sure that therelease button is not yellow. Insert a new drum,blue ring first, until it stops. It clicks into place.

Changing the Lancet Drum (continued)

IMPORTANT• Talk to your doctor before you begin using other test sites.


Running a Blood Sugar Test with Blood from Your Palm,Forearm, Upper Arm, Thigh, or Calf (non-fingertip testing)You have the option of testing other sites on your body besides the fingertip. Blood obtained from a fingertip can beused at any time to measure blood sugar. If blood from another site—palm, forearm, upper arm, thigh, or calf—isused, there are certain times when testing is not appropriate (see the next page). This is because your blood sugarlevel changes quicker in your fingertip than in other sites. These differences may cause you to make the wrongtherapeutic decision, producing adverse health effects. Please read the following section before you try testing fromother sites.


▲!

Tests from sites other than your fingertip may be done:• Immediately before a meal• Fasting

Fingertip test only:• Two hours or less after eating• After exercising• If you are sick• If you think your blood sugar is low• If you often don’t notice when your blood sugar 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

Do not change your treatment because of just one result.

NEVER ignore symptoms of high or low blood sugar.

If your blood sugar doesn’t match how you feel, do a fingertip test to confirm your result. If thefingertip result still doesn’t match how you feel, call your doctor.

Running a Blood Sugar Test (non-fingertip) (continued)

You need the meter, a test strip, a lancet device with a drum loaded, and the clear cap from your kit.

1. Remove the blue cap from the lancet deviceby pulling it straight off. It is not a twist cap.The easiest way to do this is to place yourthumb to the side of the notch as seen in theillustration.

2. Put the clear cap on by lining up the notchedsections on the cap and the lancet device.



3. Dial the depth selectionappropriate for your testingsite.

4. Press the plunger in as far asit will go, like a pen. Therelease button turns yellow.Set the lancet device asideuntil later in the test.

5. Put a test strip into the meterin the direction of the arrow.The meter turns on.

Note: We suggest starting at a depth setting of 5 1/2 for forearm, upper arm, thigh, or calf testing, and3 for palm testing. Once you run a successful test, you may want to find the lowest depthsetting that provides enough blood with the least amount of pain.



6. Make sure the code number on the displaymatches the code number on the test stripcontainer. If you miss seeing the code number,remove the test strip and reinsert it into themeter.

7. When the blood drop symbol flashes, obtain ablood drop from the site.

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Yellow releasebutton

8. Press the opening of the clear cap firmly againsta fleshy area on the non-fingertip site. Press thelancet device up and down in a slow pumpingmotion to assist the flow of blood. Rememberthat the opening where the lancet comes out isnot in the center of the cap.

9. Keep steady pressure on the area and press theyellow release button. Don’t be afraid to applypressure to the area with the lancet device toassist the flow of blood. Continue to press thecap against the area for a few seconds to allowblood to come to the surface.

TIP: Rub the skin prior to lancing to increase blood flow.



10. Touch the blood drop to the tip of the yellowwindow of the test strip. Do not put blood ontop of the test strip.

11. When you see flash, you have enough blood inthe test strip. If you applied blood but do not seethe flashing you may reapply more blood withinfive seconds.


12. Your result appears on the display. If you want toflag your test result for a special event, leave thetest strip in the meter. (See “Flagging TestResults.”) Otherwise, throw the used test stripaway.

13. For virtually pain-free testing, we recommend thatyou advance to a new, sterile lancet after each test.To load the next lancet, twist the plunger one-quarter turn forward (until it stops), then twist itback all the way.


14. The lancet counter decreases by one whitebar. For safety reasons, once you advance toa new lancet, you cannot go back to a usedlancet.


Having trouble testing from sites other than your fingertip?If you experience difficulty obtaining a sufficientdrop of blood while testing from a site otherthan your fingertip, please contact the ACCU-CHEK Customer Care Service Center at 1-800-858-8072 for assistance. We will guideyou through the testing procedure step by step.If you continue to have difficulty, we can alsooffer you, free of charge, our ACCU-CHEKSoftclix lancet device. Because the ACCU-CHEKSoftclix lancet has a thicker diameter needlethan the ACCU-CHEK Multiclix lancet, you mayhave better success when trying to test fromsites other than your fingertip.


Flagging Test ResultsYou might want to flag an event such as an after-meal (post prandial) test, exercise or a non-fingertip result. Ifyou wish, you can “flag” your test result with an asterisk ( ) to mark a special result. When you review yourresults in memory, this “flag” can help you remember what was different about the result.

Here is how to flag a result:

1. Run a test.

2. With the test result on the display, and the test strip STILL IN THE METER,press or once. The appears just below the date.

3. Remove and throw the used test strip away.


flag


Understanding Your Test ResultsNormal Blood Glucose ValuesThese test strips are calibrated to deliver plasma-like results. The normal fasting blood sugar range for anadult without diabetes is 74 – 106 mg/dL.1 Two hours after meals, the blood sugar range for an adult withoutdiabetes is less than 140 mg/dL.2 For people with diabetes: please consult your doctor for the blood sugarrange appropriate for you. You should treat your low or high blood sugar as recommended by your doctor.

Blood glucose concentrations may be measured in whole blood or plasma. Although you always apply wholeblood to the test strip, when using these test strips, your meter shows results equivalent to the glucoseconcentrations in plasma.

Unusual Test ResultsIf your blood sugar result doesn’t match the way you feel, follow these steps:

1. Run a control test, Chapter 2, “Control Testing”

2. Repeat a blood sugar test, Chapter 3, “Testing Your Blood Sugar with Blood from Your Fingertip.”

3. If your blood sugar results still don’t match how you feel, follow your doctor’s instructions or call your doctorimmediately.

Note:• Always follow your doctor’s instructions. For example, if your doctor has advised you to immediately treat

a low blood sugar result (such as by eating something), then do that first.


Symptoms of High or Low Blood SugarBeing aware of the symptoms of high or low blood sugar can help you understand your test results anddecide what to do if they seem unusual. Here are the most common symptoms:

High blood sugar (hyperglycemia): fatigue, increased appetite or thirst, frequent urination, blurred vision,headache, general aching, or vomiting.

Low blood sugar (hypoglycemia): sweating, trembling, blurred vision, rapid heartbeat, tingling, or numbnessaround mouth or fingertips.

If you are experiencing any of these symptoms, test your blood sugar. If your blood sugar result isdisplayed as LO or HI and you have symptoms of low or high blood sugar, follow your doctor’sinstructions or contact your doctor immediately. If your blood sugar result does not match how youfeel, follow the steps under “Unusual Test Results.”


Comparing Your Meter Result to a Lab ResultA common question is how the blood sugar results on your meter compare to the lab results. Your blood sugarcan change quickly, especially after eating, taking medication, or physical activity. If you test yourself in themorning, then go to the doctor’s office for a blood sugar test, your results will probably not match, even if youare fasting. This is typically not a problem with your meter, it just means that time has elapsed and your bloodsugar has changed.

If you want to compare your meter result to the lab result, you must be fasting. Take your meter to the doctor’soffice, and test yourself by fingerstick within five minutes of having blood drawn from your arm by a healthcareprofessional. Keep in mind that the lab uses different technology than the meter, and that blood glucosemeters for self testing generally read somewhat lower than the lab result.

If you are fasting and you do a fingerstick test within five minutes of having your blood drawn, here are thegeneral guidelines to compare your meter result to the lab result:

• If your blood sugar is below 75 mg/dL, your results generally should fall within 15 mg/dL of the lab result.

• If your blood sugar is equal to or over 75 mg/dL, your results generally should fall within ±20% of the lab result.

▲! Do not change your therapy based on an individual result in memory.Talk to your doctor before changing therapy based on results in memory.

48

Notes:• 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 4, “Setting 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.

• The control results are stored in memory, but cannot be reviewed on the meter. The stored results must first bedownloaded to a compatible software application. For product availability, please contact Roche Diagnostics.

• Control results are not included in the 7, 14, and 30 day averages.

Chapter 4: Meter Memory, Setup, and DownloadingMemoryStoring Test ResultsYour meter automatically stores up to 500 test results with the time and date of the test. You can review themat any time. Test results are stored from the newest to the oldest. It is very important to have the correct timeand date set in the meter. Having the correct time and date setting helps ensure appropriate interpretation ofblood sugar results by you and your healthcare team.

Chapter 4: Meter Memory, Setup, and Downloading 49

Viewing Test Results1. Press either or to enter memory. Your most recent result appears.

2. Press to view previous results in order.

3. OR, press to look at your 7, 14, or 30 day averages, in that order. You see an “n” with a number in theupper left corner of the display. This tells you how many test results are included in that average.

And so on…7-Day

average14-Day average

30-Day average

Third mostrecent result

Second mostrecent result

Most recent result


Meter SetupUsing the Set ModeBy using the set mode, you can personalize your 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

Test reminders—select 1-4 times a day for a reminder to test

Hypoglycemic (Hypo) indicator—select on or off. If you choose on, choose the blood sugar level for the indicator.

Throughout this section, the purple progress bar helps guide you through the setup process.


Setting the Time and Date

TIME / DATE(hrs, min, am/pm,month, day, year)

BEEPER(on/off)

TEST REMINDERS(A-1, A-2, A-3, A-4)

HYPO(off, on, level)

You are here

1. Press to turn the meter on. The flashingtest strip symbol appears.

2. To enter the set mode, press and hold forabout four seconds. “Set” flashes on thedisplay. The hour flashes.

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Setting the Time and Date (continued)

3. Press and release or to decrease or increase the hour. Press and hold

or to scroll faster.

4. Press and release to set the hour.The minutes flash.

decrease increase


5. Repeat steps 3 and 4 to set the minutes,am/pm, month, day, and year. The flashing field is the one you are changing.

6. If you want to set up more options, press andrelease . If you want to exit, press and hold

until the flashing test strip symbol appears.

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Note: You can press and hold or to scroll faster.

decrease increase

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Setting the Beeper On/OffYour new meter has the beeper preset to “On.” You can set the beeper to “OFF,” if you prefer—this won’taffect your test results.

The beeper is helpful because it prompts you:

• To apply blood or control solution to the test strip

• When enough blood or control solution is drawn into the test strip

• When the test is complete

• When a button is pressed

• When it is time to test (if you set test reminders)

• If an error occurred while testing (even if the beeper is set to “OFF,” it still beeps for an error)

TIME / DATE(hrs, min, am/pm, month,

day, year)

BEEPER(on/off)



You are here


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1. Press to turn the meter on.The flashing test strip symbolappears.

2. To enter the set mode, pressand hold for about fourseconds. “Set” flashes on thedisplay.

3. Press and release repeatedlyuntil you reach the display withthe flashing beeper symbol and“On.”

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4. Press or to select “On” or “OFF.” 5. If you want to set up more options, press andrelease . If you want to exit, press and holduntil the flashing test strip symbol appears.

Setting the Beeper On/Off (continued)


Setting Test RemindersTest reminders are a handy way to remind you to test. You can set 1 to 4 reminders per day. The meter beepsat the time you set, again two minutes later, and two minutes after that unless you insert a test strip or pressany button. You must have the beeper set to “On” for this option. Your meter is preset with the test reminderset to “OFF.” You must turn it on to use this feature.

If you turn A-1, A-2, A-3 and A-4 on, your meter is preset with the following times for your convenience.You can adjust the times to suit your needs.A-1 8:00 am A-3 6:00 pmA-2 12:00 pm (noon) A-4 10:00 pm

Notes:• If you tested within 30 minutes of a test reminder, the reminder does not occur.

• If the meter is on at the test reminder time, the reminder does not occur.

• When the meter beeps for a test reminder, the time, the reminder number (A-1 to A-4), and the flashingbeeper symbol are displayed.

TIME / DATE(hrs, min, am/pm,month, day, year)

BEEPER(on/off)



You are here


1. Press to turn the meter on.The flashing test strip symbolappears.

2. To enter the set mode, press andhold for about four seconds.“Set” flashes on the display.

3. Press and release repeatedlyuntil you reach the display withthe beeper symbol, “OFF,” andthe flashing “set” and “A-1.”When you are setting the timefor test reminders, the beepersymbol remains on the displayand “set” flashes continuously.

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Setting Test Reminders (continued)


4. Press and release or to select “On” or “OFF.” Pressand release to set yourchoice.

5. If you select “On,” the hourflashes. “A-1” remains on thedisplay.

6. Press and release or to select the hour. Press andrelease to set the hour.

7. The minutes flash. Press andrelease or to select00, 15, 30, or 45. These are theonly choices.

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8. Press and release to setminutes. Am or pm flashes onthe display.

9. Press or to switchbetween am and pm. Press andrelease to set am or pm.

10. The next test reminder “A-2”and “set” flash on the displaywith “OFF” and the beepersymbol. You can set additionaltest reminders or press andhold until you see theflashing test strip symbol toexit the set mode.

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Setting Test Reminders (continued)


Setting the Hypoglycemic (Hypo) Indicator

TIME / DATE(hrs, min, am/pm, month,

day, year)

BEEPER(on/off)



You are here

You can set the meter to let you know when your result indicates a possiblelow blood sugar (hypoglycemia). You can also select what blood sugar levelyou want this indicator to have (60 to 80 mg/dL). Before you set theindicator, talk to your doctor to help you decide what blood sugar levelis your hypo level. Your meter is preset to “OFF” for the hypo indicator. Ifyou want to turn it “On,” follow these steps. | |

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1. Press to turn the meteron. The flashing test stripsymbol appears.


2. To enter the set mode, pressand hold for about fourseconds. “Set” flashes on thedisplay.

3. Press and release repeatedlyuntil you reach the display with“OFF” and the flashing “set” and“hypo?”

4. Press and release or to switch between “On” and“OFF.” Press and release toset your choice.

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Setting the Hypoglycemic (Hypo) Indicator (continued)| |

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5. If you select the hypo indicator“On,” “set,” and “hypo?” flash.The display shows 70 mg/dL.

6. Press and release or to select the level between 60to 80 mg/dL. Press and release

to set it.

7. Press and hold until yousee the flashing test stripsymbol to exit the set mode.

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▲! This function is no substitute for hypoglycemia training by your doctor or diabetes team.


Downloading Your Results to a ComputerWe offer a variety of software to help you download your results.For information on ACCU-CHEK software, call the ACCU-CHEK Customer Care Service Center at 1-800-858-8072.

You can transfer your stored results to a computer to track, identify patterns, and print.

Transferring Data Directly to a Computer or PDAUsing Specialized Software and Infrared Cable1. 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 downloadinformation. Make sure the software is ready to accept data from the meter.

3. With the meter off, press and hold both and until two arrows on the display alternately flash.

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.

Infrared (IR)Window


6. Put the meter on a flat surface. Point the two IR windows toward each other. They should be 1 to 4 inches apart.

7. Do not move the infrared cable (computer), PDA, or meter during the transfer.

8. Follow the prompts on the software.

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. If you still have problems, call the ACCU-CHEK Customer

Care Service Center at 1-800-858-8072.

• To make the most of the download feature, you must set the time and date correctly.

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Chapter 5: Maintenance and TroubleshootingChanging the Battery1. 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. It doesn’t snap into place but rests on the metal contact. The door holds the battery down.

3. Put the battery door back in place and snap it closed.

Notes:• The meter uses one 3-volt

lithium battery, coin cell 2032.This type of battery can be foundin many stores. Always keep aspare packaged battery on hand.

• Be sure the battery goes in + side up or facing you.

• After you change the battery,your meter prompts you toconfirm the meter’s time anddate settings. See Chapter 4,“Setting the Time and Date.” Alltest results are saved in memory.

Chapter 5: Maintenance and Troubleshooting 67

Cleaning Your MeterCaring for your ACCU-CHEK Aviva meter is easy - just keep it free of dust. If you need to clean it, follow theseguidelines carefully to help you get the best performance possible:

Do• Make sure the meter is off

• Gently wipe the meter’s surface with a soft clothslightly dampened (wring out any excess liquid)with one of these cleaning solutions:

• 70% rubbing alcohol

• Mild dishwashing liquid mixed with water

• 10% household bleach solution (1 partbleach plus 9 parts water) made the same day

Do Not• Get any moisture in the code key 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

Chapter 1: Your New Meter 68Chapter 5: Maintenance and Troubleshooting 68

Your meter needs little or no maintenance with normal use. It automatically testsits own systems every time you turn it on and lets you know if something iswrong. (See Chapter 5, “Screen Messages” and what to do about them.)

If you drop the meter or think it’s not giving accurate results, make sure that yourtest strips and control solution haven't expired, then run a control test.

Periodically test your display to make sure it is working properly. To test thedisplay, turn off the meter, then press and hold to see the complete display. Allthe segments should be clear and look exactly like the picture to the left. If one ofthe segments is missing or looks different from the picture, do not use the meter.Call the ACCU-CHEK Customer Care Service Center at 1-800-858-8072.

Cleaning Your Lancet DeviceClean the outside of the ACCU-CHEK Multiclix lancet device regularly with 70% isopropyl (rubbing) alcohol.DO NOT place the entire device under water. DO NOT use bleach. At least once a week, disinfect the cap aftercleaning by placing it in 70% rubbing alcohol for 10 minutes. Allow the cap to air-dry after disinfecting.

Maintenance and Testing


▲!

Screen Messages and TroubleshootingNever make treatment decisions based on an error message. If you have any concerns,call the ACCU-CHEK Customer Care Service Center at 1-800-858-8072.

The meter won’t turn on or thedisplay is blank.

• Battery is dead —Insert new battery.

• Display is damaged —Call the ACCU-CHEK CustomerCare Service Center at 1-800-858-8072.

• Extreme temperatures —Move the meter to roomtemperature.

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| The meter is in setmode, waiting foryou to change orconfirm settings.See Chapter 4,“Meter Setup.”

Battery power islow. Change thebattery soon. SeeChapter 5,“Changing theBattery.”

(blank screen)


The meter is ready for you toinsert a test strip.

The meter is ready for a dropof blood or control solution.

Result may be higher than themeasuring range of thesystem. See Chapter 3,“Understanding Your TestResults.”

Result may be lower than themeasuring range of thesystem. See Chapter 3,“Understanding Your TestResults.”

This test result was flagged.See Chapter 3, “Flagging TestResults” for more details.

Result is below the definedhypo (low blood sugar) level.See Chapter 3, “UnderstandingYour Test Results.”

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The meter isn’t coded or thecode key isn’t all the way in.Turn off the meter and recode it.See Chapter 1, “Coding YourMeter.”

The code key is incorrect. Turnoff the meter and insert a newcode key. If this doesn’t fix theproblem, call the ACCU-CHEKCustomer Care Service Centerat 1-800-858-8072.

The temperature is above orbelow the proper range for themeter (43-111°F). Move to anarea between 43 and 111°F,wait five minutes and repeat thetest. Do not artificially heat orcool the meter.

Battery is almost out of power.Change the battery now. SeeChapter 5, “Changing theBattery.”

Your blood sugar may beextremely low, or the test stripmay be damaged or not properlyinserted. If you see this errormessage after you apply bloodto the test strip, see Chapter 3,“Unusual Test Results.” If yousee this error message beforeyou apply blood to the test strip,remove the test strip andreinsert it, or replace it ifdamaged. If the messagereappears, call the ACCU-CHEKCustomer Care Service Center at1-800-858-8072.

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Blood or control solution wasapplied to the test strip before theflashing drop appeared on thedisplay. Discard the test strip andrepeat the test.

The test strips will expire at theend of the current month. Beforethe end of the month, insert a newcode key from a new box of teststrips and ensure the code keynumber matches the code numberon the test strip container. Makesure the time and date in themeter are correct.

The code key is from anexpired lot of test strips.Ensure the code keynumber matches the codenumber on the test stripcontainer. Make sure thetime and date in the meterare correct.

Not enough sample wasdrawn into the test strip formeasurement or samplewas applied after the testhas started. Discard the teststrip and repeat the test.|

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An error occurred during the test.Discard the test strip and repeat thetest. See Chapter 1, “UnderstandingYour New System.”

An electronic error occurred. Turnthe meter off and on. Take thebattery out for a few seconds andreinsert it. If the problem persists,call the ACCU-CHEK Customer CareService Center at 1-800-858-8072.

The time and date settingsmay be incorrect. Make surethe time and date are correctand adjust, if necessary. SeeChapter 4, “Setting the Timeand Date.”

Note: If you see any other error screen, please call the ACCU-CHEK Customer Care Service Center at 1-800-858-8072.

Chapter 6: Technical Information 74

Chapter 6: Technical InformationProduct LimitationsPlease read the literature packaged with your test strips to find the latest information on product specificationsand limitations.

SpecificationsDisplay LCD

Automatic power off 2 minutesPower supply One 3-volt lithium battery (coin cell 2032)

Protection class IIIMeter type The ACCU-CHEK Aviva meter is suitable for continuous

operationBlood volume Refer to the test strip package insert

Measuring range Refer to the test strip package insertSample type Refer to the test strip package insert

Measuring time Refer to the test strip package insertSystem operating conditions Refer to the test strip package insert

Meter storage conditions Temperature: -13 to 158ºFTest strip storage conditions Refer to the test strip package insert

Relative humidity operating range 10 to 90%


Altitude Up to 10,150 feetMemory capacity 500 results with time and date

Dimensions 94 x 53 x 22 mm (LWH)Weight Approx. 60 g (with battery)

Construction Hand-heldLancet device depths 0.80, 0.95, 1.10, 1.25, 1.40, 1.55, 1.70,

1.85, 2.00, 2.15, 2.30 mm

Electromagnetic CompatibilityThis meter meets the electromagnetic immunity requirements as per EN ISO 15197 Annex A. The chosenbasis for electrostatic discharge immunity testing was basic standard IEC 61000-4-2. In addition, it meets theelectromagnetic emissions requirements as per EN 61326. Its electromagnetic emission is thus low.Interference from other electrically driven equipment is not to be anticipated.

Performance AnalysisThe performance data for the ACCU-CHEK Aviva system (ACCU-CHEK Aviva meter with ACCU-CHEK Aviva teststrips) 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 containingvarious levels of glucose. The reference values are obtained using the glucose hexokinase method. For methodcomparison, the results were compared with results obtained using the glucose hexokinase method withdeproteinization (automatic analyzer). The glucose hexokinase method is traceable to an NIST standard.

The ACCU-CHEK Aviva system meets the EN ISO 15197 requirements.


CAUTION

Please refer to safety-related notes in

the manual accompanyingthis instrument.

3-volt battery coincell 2032

The ACCU-CHEK Aviva meter hasbeen listed by Underwriter’s

Laboratories, Inc.©, in accordancewith UL 3101-1 and CAN/CSA

C22.2 No. 1010-1

Store at This product fulfills therequirements of

Directive 98/79/EC onin vitro diagnosticmedical devices.

Measuring PrincipleThe enzyme on the test strip, glucose dehydrogenase, in the presence of the coenzyme (PQQ), converts theglucose in the blood sample to gluconolactone. This reaction creates a harmless DC electrical current that yourmeter interprets for your blood glucose. The sample and environmental conditions are also evaluated using asmall AC signal.

Product Safety Information

Explanation of Symbols

▲! 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.


Travel DocumentationIf you are traveling on a commercial airline, you may be required to provide documentation certifying that thismeter meets environmental conditions and test procedures for Airborne Equipment (RTCA/DO-160E) section 21Emission of Radio Frequency Energy. Please visit www.accu-chek.com or call the ACCU-CHEK Customer CareService Center at 1-800-858-8072 to obtain a copy of the document.

Disposing of the MeterIf you need to throw your meter away:

The European Union has a requirement for improving waste management practices for certain electronicequipment.* This is not a requirement for the U.S.A.; however, please consider these points if you ever need todispose of your blood glucose meter. Any product coming in contact with blood is considered contaminated(potentially infectious).** During normal testing use, any blood glucose meter may come in contact with blood.

Users in professional environments (e.g. healthcare facilities) should follow their existing policies andprocedures that govern disinfection and/or disposal of potentially infectious waste. Consumers should useappropriate caution if they find a need to dispose of their used meter. We suggest that you also remove thebattery before disposing.

*Directive 2002/96/EC—Directive on waste electrical and electronic equipment (WEEE)**29 CFR 1910.1030—Bloodborne pathogens


ACCU-CHEK Aviva 30-day Money-back GuaranteeRoche Diagnostics offers consumer purchases a 30-day money back guarantee. If you are not fully satisfied with your ACCU-CHEK Blood Glucose meter, call the ACCU-CHEK Customer Care Service Center toll-free at 1-800-858-8072 for a fullrefund. Refund will be limited to amount paid by consumer net of any rebates. Consumers covered under Medicare, Medicaid,other federal/state programs, or private insurance are NOT eligible for this money-back offer. Consumers affected by thisexclusion may instead request a different ACCU-CHEK meter/system. You must have a copy of the dated itemized purchasereceipt and the original packaging to obtain this refund.

ACCU-CHEK Aviva Limited 3-Year WarrantyRoche Diagnostics warrants to the original purchaser of the meter that your ACCU-CHEK Aviva meter will be free from defectsin materials and workmanship for 3 years from the date of purchase. If, during this 3-year period, the meter does not workproperly because of a defect in materials or workmanship, Roche Diagnostics will replace it with a new ACCU-CHEK Avivameter or equivalent product free of charge. The warranty on the replacement meter will expire on the date of the originalwarranty expiration or 90 days after the shipment of a replacement system, whichever period is longer. The purchaser’sexclusive remedy with respect to the ACCU-CHEK Aviva meter shall be replacement.

This warranty does not apply to the performance of an ACCU-CHEK Aviva meter that has been damaged by accidentor has been altered, misused, tampered with, or abused in any way. Roche Diagnostics will handle meters that showdamage or abuse according to its Non-Warranty Service Policy described below.

THE ABOVE WARRANTY IS EXCLUSIVE OF ALL OTHER WARRANTIES, AND ROCHE DIAGNOSTICS MAKES NO OTHERWARRANTIES, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION, THE IMPLIED WARRANTY OFMERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. IN NO EVENT SHALL ROCHE DIAGNOSTICS BE LIABLETO THE PURCHASER OR ANY OTHER PERSON FOR ANY INCIDENTAL, CONSEQUENTIAL, INDIRECT, SPECIAL, OR


PUNITIVE DAMAGES ARISING FROM OR IN ANY WAY CONNECTED WITH THE PURCHASE OR OPERATION OF THEMETER OR ITS PARTS. NO WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, IF ANY ISIMPLIED FROM THE SALE OF THE METER, SHALL EXTEND FOR A LONGER DURATION THAN THREE YEARS FROM THEDATE OF PURCHASE.

Some states do not allow limitations on how long an implied warranty will last or the exclusion of incidental orconsequential damages, so the above limitation and exclusion may not apply to you. This warranty gives you specific legalrights, which vary from state to state.

Non-Warranty Service PolicyRoche Diagnostics’ Non-Warranty Service Policy applies to meters where the above warranty has not become effective,has become inapplicable, or has expired. Replacement will be with the same or similar product. Replacement meters willbe warranted for a period of 90 days from shipment under a limited warranty providing for replacement of parts and laborat no charge.

Warranty and Service InstructionsAll requests for return of ACCU-CHEK Aviva meters under the above warranty or service policy must be made to the ACCU-CHEK Customer Care Service Center. You will be mailed a return authorization label, which must be affixed to your cartonfor shipping the system to Roche Diagnostics. Cartons received without this label will be returned to you at your expense.

Customers experiencing difficulties should review the troubleshooting information in Chapter 5 of this booklet. Furtherinquiries should be directed to the ACCU-CHEK Customer Care Service Center.

Be sure to fill out and mail the Warranty Card that comes with the ACCU-CHEK Aviva system.


▲! CAUTION—A RESTRICTED LICENSE LIMITS USE OF THE ACCU-CHEK® AVIVA SYSTEM—READ CAREFULLY THE LIMITATIONS RECITED BELOW.

The ACCU-CHEK Aviva system (meter, including the code key, and test strips) and its use are protected by U.S. Patent Nos.6,645,368; 5,366,609; 5,352,351; 5,053,199; 5,122,244 and Re. 36,268. A license to use the ACCU-CHEK Aviva system is onlygranted when the ACCU-CHEK Aviva meter is used with the ACCU-CHEK Aviva test strips and ACCU-CHEK Aviva code keys.ACCU-CHEK Aviva test strips are provided with a specifically matched ACCU-CHEK Aviva code key. These test strips andcode keys are specifically manufactured for operation with the ACCU-CHEK Aviva meter. Use of other test strips with anunmatched code key or even with the matched code key supplied by another manufacturer may prevent or impair theproper function of the ACCU-CHEK Aviva system.Using the ACCU-CHEK Aviva system indicates your acceptance of the restricted license to use the ACCU-CHEK Aviva systemonly with ACCU-CHEK Aviva test strips and the ACCU-CHEK Aviva code key. Further, if you have purchased an ACCU-CHEKAviva monitoring kit or an ACCU-CHEK Aviva meter that includes this restricted license, then this restricted license appliesregardless of any additional offers found in ACCU-CHEK Aviva test strip packages. If you do not agree to the terms andconditions of the restricted license, you may return, at the place of purchase, the unused ACCU-CHEK Aviva system for a fullrefund. If you have any questions, please call the ACCU-CHEK Customer Care Service Center at 1-800-858-8072.Except where prohibited by statute, all warranties covering the ACCU-CHEK Aviva system are voided by use of the ACCU-CHEK Aviva system with any test strips or code keys other than ACCU-CHEK Aviva test strips or code keys.Patent InformationAspects of the ACCU-CHEK Aviva system, including the meter, code key, and test strips, and their use are covered by one or more of the following United States patents: 5,352,351; 4,999,582; 5,997,817; 5,053,199; Re. 36,268; 5,438,271;5,366,609; 6,645,368; 4,891,319; 6,662,439; 5,122,244; 7,073,246. Additional United States Patents pending. U.S. PatentNo. 4,891,319 is licensed from Quadrant Holdings Cambridge Limited.

CAUTION—A RESTRICTED LICENSE LIMITS USE OF THE ACCU-CHEK® MULTICLIXDEVICE (lancet device and lancet drum). READ CAREFULLY THE LIMITATIONSRECITED BELOW.

The ACCU-CHEK Multiclix device and its use are protected by U.S. Patent Nos. 4,924,879; Re. 35,803; 6,419,661. A license touse the ACCU-CHEK Multiclix device is only granted when ACCU-CHEK Multiclix lancet drums are used with the ACCU-CHEKMulticlix device.

ACCU-CHEK Multiclix lancets are high precision components that are produced to the close tolerances required forsatisfactory operation with the ACCU-CHEK Multiclix device. Use of other lancets with the ACCU-CHEK Multiclix device mayprevent or impair proper function of the ACCU-CHEK Multiclix device.

Using the ACCU-CHEK Multiclix device indicates your acceptance of the restricted license to use the ACCU-CHEK Multiclixdevice only with ACCU-CHEK Multiclix lancet drums. Further, if you have purchased an ACCU-CHEK Multiclix device thatincludes this restricted license, then this restricted license applies regardless of any additional offers found in ACCU-CHEKMulticlix device packages. If you do not agree to the terms and conditions of the restricted license, you may return, at theplace of purchase, the unused ACCU-CHEK Multiclix device for a full refund. If you have any questions, please call the ACCU-CHEK Customer Care Service Center at 1-800-858-8072.

Except where prohibited by statute, all warranties covering the ACCU-CHEK Multiclix device are voided by use of the ACCU-CHEK Multiclix device with any lancet drums other than ACCU-CHEK Multiclix lancet drums.

Patent InformationThe ACCU-CHEK Multiclix device and its use are covered by the following U.S. patents: 4,924,879; Re. 35,803; 6,419,661.Additional U.S. patents pending.

▲!



Additional SuppliesThe following supplies and accessories are available from your authorized Roche Diagnostics diabeteshealthcare center, pharmacies, or your medical/surgical supply dealer:

Test StripsACCU-CHEK Aviva 50 ct test stripsACCU-CHEK Aviva 100 ct test strips

Control SolutionsACCU-CHEK Aviva 2 level control solutions

LancetsACCU-CHEK Multiclix lancet 102 ct drums


Information for Healthcare ProfessionalsHealthcare Professionals: Follow the infection control procedures appropriate for yourfacility.

Decisions about whether to recommend alternative site testing (AST) should take into account the motivationand knowledge level of the patient and his or her ability to understand the considerations relative to diabetesand AST. If you are considering recommending AST for your patients, you need to understand that there is apotential for a significant difference between fingertip and alternative site blood glucose test results. Thedifference in capillary bed concentration and blood perfusion throughout the body can lead to sample site-to-site differences in glucose results. These physiological effects vary between individuals and can vary within asingle individual based upon his or her behavior and relative physical condition. Our studies involving AST ofadults with diabetes show that most persons will find their glucose level changes more quickly in thefingertips’ blood than the alternative sites’ blood.* This is especially important when glucose levels are fallingor rising rapidly. If your patient is used to making treatment decisions based upon fingertip readings, he orshe should consider the delay, or lag-time, affecting the reading obtained from an alternative site.

*Data on file.

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References1. Stedman, TL, Stedman’s Medical Dictionary, 27th Edition, 1999, pg. 2082.

2. American Diabetes Association, “Clinical Practice Recommendations 2003.” Diabetes Care, Vol 26,Supplement 1, pg. S22.

Indexappetite, increased, 46

battery, changing, 66

battery, type, 66

beeper settings, 54

blood sugar, testing, 24

blurred vision, 46

button, on/off, 8

code key, 8, 10

comfort dial 9, 27

computer,connecting your meter to, 64

control solution, 16

control test results,understanding, 21

control test, acceptable range, 21

control test, results, 21

control test, running 17

control test,unacceptable range, 22

dehydration, 4

display check, 68

error messages, 71 – 73

fatigue, 46

frequent urination, 4, 46

high blood sugar, 46

hyperglycemia, 46

hypoglycemia, 5, 46

lancet drum, 9, 24

limited license, 80 – 81

low blood sugar, 46

maintenance, meter, 68

memory, meter, 48

numbness, 46

patent information, 80 – 81

product limitations, 74

product specifications, 74

professional caregivers, 83

rapid heartbeat, 46

screen messages, 69 – 73

settings, meter, 50

supplies, 82

sweating, 46

symbols, 76

technical information, 74 – 77

test results, understanding, 45

test results, unusual, 45

test strips,ACCU-CHEK Aviva, 9, 14

thirst, increased, 46

time and date, setting, 51

tingling, 46

travel, 77

trembling, 46

Index 85

troubleshooting, 69 – 73

use by, 14, 16

warranty, 78 – 79

Index 86

ACCU-CHEK® Aviva

©2007 Roche Diagnostics. All rights reserved. 04447344004-0307Assembled and distributed in the U.S.A. by Roche Diagnostics, Indianapolis, IN.

Roche Diagnostics9115 Hague RoadIndianapolis, IN 46256

ACCU-CHEK, ACCU-CHEK AVIVA, and ACCU-CHEK MULTICLIX are trademarks of Roche.EXTRANEAL is a trademark of Baxter International.OCTAGAM is a trademark of Octapharma.

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