with drugs that contain or break down into maltose, you should not use the ACCU-CHEK Aviva test strip. It will cause inaccurate results. Ask your doctor about alternative testing methods. See the Limitations section. This system has been tested at altitudes up to 10,150 feet.
You dropped the meter Your blood sugar result doesnt agree with how you feel You want to check if you are testing correctly

STEP 4 Your results

Whats a normal blood sugar result?
These test strips are calibrated to deliver plasma-like results. The normal fasting blood glucose range for an adult without diabetes is 74 - 106 mg/dL.1 Two hours after meals, the blood glucose range for an adult without diabetes is less than 140 mg/dL.2 For people with diabetes: please consult your doctor for the blood glucose range appropriate for you. Blood glucose concentrations may be measured in whole blood or plasma. Although you always apply whole blood to the test strip, when using these test strips, your meter will show results equivalent to the glucose concentrations in plasma.
Testing from sites other than your fingertip
You have the option of testing other sites on your body besides the fingertip. Blood obtained from a fingertip can be used at any time to measure blood sugar. If blood from another sitepalm, forearm, upper arm, thigh, or calfis used, there are certain times when testing is not appropriate (see below). This is because your blood sugar level changes quicker in your fingertip than in other sites. These differences may cause you to make the wrong therapeutic decision, producing adverse health effects. Please read the following section before you try testing from other sites.
How to run a control test
Follow the directions found in the control solution box or the meter Owners Booklet. If you need control solutions, talk to your pharmacist or visit www.accu-chek.com to order online.
Test Strips and 1 Code Key
Storing and handling the test strips
Keep the test strips in their original container with the cap closed. Close the container tightly right after you take a test strip out. This helps keep the test strips dry. Moisture can damage the test strips and lead to a wrong result. The temperature symbol means to keep the container of test strips at room temperature between 36 F and 90 F (2 C and 32 C). Do not freeze.
PERSONAL USE Important Information
If you are currently using drug therapies that contain or break down into maltose or galactose, DO NOT use the ACCU-CHEK Aviva test strip to test your blood sugar. Certain therapies can elevate the levels of maltose or galactose in your blood, leading to falsely elevated blood sugar test results.
For example: Peritoneal dialysis solutions containing icodextrin (e.g., Extraneal) Certain types of intravenous immunoglobulin therapies (e.g., Octagam 5 %) Intravenous solutions containing maltose as a means for patient hydration Note: The list of drugs mentioned above is not intended to be all inclusive and may not include recently introduced, new drugs; therefore, always consult the drug package insert to determine whether it contains or breaks down into maltose or galactose.

What the results mean

Compare the result you get to the range on the test strip container label.
If your control result is inside the range, you know the meter and test strips are working properly. You can now test your blood. If the control result is NOT within the range Check this list to see what may be causing the problem: Are the test strips or control solution past the Use by or discard date? Did you wipe the tip of the control solution bottle with a tissue before and after use? Were the test strip container and control solution bottle closed tightly? Was the test strip out of the container for more than three minutes? Were the test strips and control solutions stored in a cool, dry place? Did you follow all of the testing instructions? Did you choose the correct control solution level, either 1 or 2, when you ran the test? Does the code number on the meter display match the code number on the test strip container? For more information, check the Control Solution Package Insert or your Owners Booklet. If you still have problems, help is available 24 hours a day, 7 days a week. Call the ACCU-CHEK Customer Care Service Center at 1-800-858-8072.

IMPORTANT

Talk to your doctor before you begin using other test sites. Tests from sites other than the 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 dont notice when your blood sugar is low during peak action time of short-acting insulin or rapidacting 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 doesnt match how you feel, do a fingertip test to confirm your result. If the fingertip result still doesnt match how you feel, call your doctor. For more information on testing from sites other than your fingertip, call the ACCU-CHEK Customer Care Service Center at 1-800-858-8072.
Symptoms of high or low blood sugar
Being aware of the symptoms of high or low blood sugar can help you understand your test results and decide what to do if they seem unusual. 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 numbness around your mouth or fingertips. If you are having any of these symptoms, test your blood sugar. If your blood sugar result is displayed as HI or LO, and you have symptoms of high or low blood sugar, follow your doctors instructions or contact your doctor. For example, if your doctor has advised you to immediately treat a low blood sugar result (such as by eating something), then do so. Follow the advice of your doctor before you change your therapy!
Problems or Questions? Consumers: Call the ACCU-CHEK Customer Care Service Center at 1-800-858-8072, 24 hours a day, 365 days a year.

Purpose

The test strips are used with the ACCU-CHEK Aviva meter. The test strips, when used with this meter, tell you how much blood sugar (glucose) is in your blood with a small drop of blood. The ACCU-CHEK Aviva system is designed for monitoring glucose in the home or in healthcare facilities. Testing sites include traditional fingertip site along with palm, forearm, upper arm, thigh, and calf. Professionals may use test strips to test capillary, venous, arterial, and neonatal blood; home use is limited to capillary whole blood testing. For in vitro diagnostic use.

Do not expose the test strips to heat, moisture, or humidity. Temperatures outside the required range, as well as moisture and humidity, can damage the test strips and lead to inaccurate results. Use the test strips at temperatures between 43 F and 111 F (6 C and 44 C) and between 10 % to 90 % relative humidity. Humidity is the amount of dampness in the air. Do not keep the container in rooms where the air is humid such as a kitchen, laundry room, or bathroom. Throw the test strips away if they are past the Use by date on the test strip container. If the Use by date is missing or cannot be read, do not use the test strips. You must use the test strip within three minutes after you take it out of the container or your result may be wrong, and you will have to repeat your test. Do not apply blood or control solution to the test strip before inserting it into the meter. If a result appears before applying blood or control solution, do not act on that result. Do not reuse test strips. Once blood or control solution has been applied to a test strip, discard it. If a retest is necessary, use a new test strip.
Professionals: 1-800-440-3638 Visit our web site at www.accu-chek.com.

Unusual test results

If your blood sugar result doesnt match the way you feel, follow these steps: 1. Run a control test. 2. Review the test procedure and test yourself again with a new test strip. 3. If your blood sugar still doesnt match how you feel, follow your doctors instructions or contact your doctor immediately.
STEP 3 Testing your blood
You are now ready to test your blood. First, wash and dry your hands. Read the Getting a good drop of blood section of this insert if you have problems or are new to testing.

Technical Information

How the Test Works: Blood from your fingertip works with the chemicals in the test strip to make a small electrical current in the test strip. Your meter reads the current and gives you the blood sugar result. Contents of the test strip: See other side Performance Characteristics: See other side
STEP 1 Getting ready to test
1. Get your supplies together. You need the meter, a test strip, the code key, a lancing device, and lancet. 2. Get the lancing device ready to use. See the Owners Booklet for directions.

Introduction

Testing your blood sugar regularly helps you better manage your diabetes, which can prevent or delay further health problems. Your doctor can tell you what your healthy blood sugar range is. It is very important to stay in your healthy range. If your blood sugar is too low, you may experience sweating, blurred vision, rapid heartbeat, or numbness/ tingling of your fingertips or mouth. If your blood sugar is too high, you may have fatigue, frequent urination, thirst, belly pain, vomiting, trouble breathing or a headache. Caution: Do not eat the test strips. They are only for use outside the body (in vitro).

Procedure

1. Put the test strip into the meter in the direction of the arrows. The meter turns on. 2. Make sure the code number on the display matches the code number on the test strip container. If you miss seeing the code number, take the test strip out and reinsert it into the meter. If the code numbers dont match, refer to the Owners Booklet to get directions on how to change the code key. 3. A test strip and flashing blood drop symbol appear on the display. 4. Use the lancing device to get a drop of blood. 5. Touch the drop to the tip of the yellow window of the test strip. Do not put blood on the 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. 6. Your blood sugar result appears on the display. 7. Take the test strip out of the meter. Put the lancet and test strip in a puncture-proof container, such as a biohazard container.
Getting a good drop of blood
If you have trouble getting a good drop of blood, here are some tips: Fingertip testing Wash your hands in warm, soapy water, then rinse and dry thoroughly. (Warming your fingers can increase blood flow.) If you use an alcohol wipe, be sure the testing site is dry before getting a drop of blood. Let your hand hang by your side. (This increases blood flow.) Squeeze your finger at the knuckle for three seconds, then let go. Repeat. Prick your finger, then squeeze at the knuckle to form a drop of blood. Dont squeeze too hard. Non-fingertip testing Rub the skin prior to lancing to increase blood flow.
STEP 2 Running a control test
(Skip to step 3 if you have already done this for your container of test strips.)

Additional Information

The Owners Booklet contains more information. If you need help, call the ACCU-CHEK Customer Care Service Center at 1-800-858-8072, 24 hours a day, 365 days a year.
What control solution to use
Use the ACCU-CHEK Aviva control solutions.

References

1. Stedman, TL. Stedmans Medical Dictionary, 27th Edition, 1999, p. 2082. 2. American Diabetes Association, Clinical Practice Recommendation Guidelines 2003, Diabetes Care, Vol. 26. Supplement 1, p. S22

Before you start testing

Carefully read and follow all instructions in the package insert when testing your blood sugar. Your hematocrit (blood count) should be between 20 % and 70 %. Ask your doctor if you do not know your hematocrit. If you have poor circulation, testing your own blood sugar may not be right for you. Ask your doctor. If you are undergoing peritoneal dialysis with fluids that contain icodextrin, an active ingredient that breaks down to maltose in the bloodstream or are receiving treatment
How the control solution works
The control solution contains a known amount of sugar and acts like blood when you apply it to the test strip. Running a control test lets you know that the meter and test strips are working properly.

When to run a control test:
You open a new box of test strips You left the test strip container open or you think the test strips have been damaged The test strips were stored in extreme temperatures or humidity You want to check the meter and test strips
PROFESSIONAL USE Important Information
Patients receiving peritoneal dialysis using solutions containing icodextrin (e.g. Extraneal, Icodial) should not be tested with the ACCU-CHEK Aviva test strip. The dialysis solution may falsely elevate blood glucose results.
To minimize the effect of glycolysis, blood glucose determination with venous or arterial blood must be performed within 30 minutes of sample collection. Avoid air bubbles with the use of pipettes. Fresh venous blood specimens containing the anticoagulants EDTA or heparin (lithium or sodium) are acceptable. Iodoacetate or fluoridecontaining anticoagulants are not recommended. Refrigerated samples should be brought to room temperature slowly prior to testing.
diabetic ketoacidosis or due to hyperglycemic, hyperosmolar non-ketotic coma, hypotension, shock, decompensated heart failure NYHA Class IV, or peripheral arterial occlusive disease.
Performance Characteristics
The system is designed for monitoring blood glucose in the home or healthcare facility by persons with diabetes or by healthcare professionals. The device is intended for professional use and over-the-counter sale. Sample size: 0.6 L Test time: 5 seconds System measurement range: 10 to 600 mg/dL Hematocrit range: 20 % to 70 % Altitude: up to 10,150 feet Accuracy: Studies were conducted at one physician site for capillary blood samples with the following results:
N = 212 Y = 0.984x + 2.2 R = 0.996 Range = mg/dL
If the blood glucose result does not reflect the patients clinical symptoms, or seems unusually high or low, run a control test. If the control test confirms that the system is working properly, repeat the blood glucose test. If the repeated blood glucose result still seems unusual, follow facility guidelines for further action. Discard used test strips and blood collection devices per facility infection control policy.
Problems or Questions? Professionals: 1-800-440-3638 Consumers: Call the ACCU-CHEK Customer Care Service Center at 1-800-858-8072, 24 hours a day, 365 days a year.
Visit our web site at www.accu-chek.com.
Information for Healthcare Professionals
Specimen Collection and Preparation
Always wear gloves and follow your facilitys infection control procedures when handling blood-contaminated items. Always adhere to the recognized procedures for handling objects that are potentially contaminated with human material. Follow the hygiene and safety policy of your laboratory or institution. Prepare the selected blood collection site per facility policy. A drop of fresh whole blood is required to perform a blood glucose test. Capillary blood may be used. Venous, neonatal, or arterial blood may be used only if drawn by healthcare professionals.

Test Principle

The enzyme on the test strip, glucose dehydrogenase, in the presence of the coenzyme (PQQ), converts the glucose in the blood sample to gluconolactone. This reaction creates a harmless DC electrical current that your meter interprets for your blood glucose result. The sample and environmental conditions are also evaluated using a small AC signal. Contents of the test strip Minimum at time of manufacture.
Mediator Glucose dehydrogenase* Buffer Stabilizer Nonreactive ingredients 6.42 % 2.87 % 11.53 % 3.37 % 75.80 %
Consumer Blood Study: Studies were conducted where capillary blood sample results obtained by untrained patients from three physician offices gave the following results:
N = 97 Y = 0.957x + 2.7 R = 0.982 Range = mg/dL
Precision: Within-run precision using control solutions and blood was excellent at all levels tested:
Control Solutions N Mean SD CV Blood N mean SD CV Low (mg/dL) 1.1 -1.6 -Mid (mg/dL) 2.4 1.143 3.7 2.6 High (mg/dL) 5.0 1.341 7.5 2.2
*from A. calcoaceticus, recombinant from E. coli

Limitations

WARNING: Patients receiving peritoneal dialysis using solutions containing icodextrin (e.g. Extraneal, Icodial) should not use the Accu-Chek Aviva test strip. The dialysis solution may falsely raise blood glucose results. The injection or infusion of solutions containing galactose or maltose (present in some human immunoglobulin preparations, e.g. Octagam 5 %) may cause overestimation of blood glucose results. Blood concentrations of galactose >10 mg/dL or maltose >13 mg/dL will cause overestimation of blood glucose results. The Accu-Chek Aviva test strips are for testing fresh capillary, venous, arterial, or neonatal whole blood. Do not use the ACCU-CHEK Aviva system during a xylose absorption test. Lipemic samples in excess of 4800 mg/dL may produce elevated results. If peripheral circulation is impaired, collection of capillary blood from the approved sample sites is not advised as the results might not be a true reflection of the physiological blood glucose level. This may apply in the following circumstances: severe dehydration as a result of
These studies show that the ACCU-CHEK Aviva system compares well with a plasma lab method.

Patent Information

U.S. Patent Nos. 5,122,244; 5,997,817, 6,662,439; 7,073,246; 7,386,937.
Roche Diagnostics 9115 Hague Road Indianapolis, IN 46256 Assembled in U.S.A. www.accu-chek.com ACCU-CHEK and ACCU-CHEK AVIVA are trademarks of Roche. All other product names and trademarks are the property of their respective owners. 2008 Roche Diagnostics. All rights reserved. 04473345006-0608
Venous or Arterial Samples
The following criteria need to be met when performing a blood glucose test on venous or arterial samples. Caution should be taken to clear arterial lines before blood is drawn. The system has been tested with neonatal blood (capillary, cord blood). As a matter of good clinical practice, caution is advised in the interpretation of neonate glucose values below 50 mg/dL. Please follow the recommendations for follow-up care that have been set by your institution for critical glucose values in neonates. Results for neonates exhibiting symptoms of galactosemia should be confirmed by laboratory tests.

Chapter 1: Understanding Your New System*
The ACCU-CHEK Aviva Meter
Display Shows results, messages, and results stored in memory. Right and Left Arrow Buttons Press to view memory, adjust settings, and scroll through results. Test Strip Slot Insert test strip here. Infrared (IR) Window Transfers data from the meter to a computer or PDA. Code Key Slot Insert code key into this opening.
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 Key (for example)
Battery Insert with (+) symbol facing up.
Golden End Insert this end of the test strip into the meter. Yellow Window Touch blood drop or control solution here.
*Some items may be sold separately. On/Off/Set Button Infrared (IR) Window

Test Strip

Test Strip Container

Control Solution Bottle

Top View
Comfort Dial with Depth Selection Cap Clear Cap (for obtaining blood from sites other than your fingertip) Release Button Lancet Counter

Lancet Drum

Depth Indicator 9

Lancing Device

Plunger
Chapter 1: Your New Meter

Coding the Meter

A new code key is inside each new box of test strips.
1. Make sure the meter is off.

2. Turn the meter over.

3. Remove the old code key (if there is one in the meter) and discard it.
Change the code key every time you open a new box of test strips! For accurate results, it is important to be sure the code key matches the code number on the test strip container.
Chapter 1: Understanding Your New System

Notes:

Dont 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 number faces away from you. Push it into the code key slot until it stops.
5. Leave the code key in the meter until you open a new box of test strips. Remember to change the code key each time you open a new box of test strips.
Adjusting the Time and DateFirst Time Use
Your 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 to download your results to a computer. It also helps your healthcare team interpret your results.

decrease

1. Press and release to turn the meter on. The time and date appear on the display. Set-up and the hour flash. If this is the correct time and date, press and hold to exit the set-up mode.

increase

3. Press and release to set the hour. The minutes flash.
or to 2. Press and release decrease or increase the hour. Press and hold or 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. If it is correct, press and hold

to exit the set-up mode.

4. Repeat steps 2 and 3 to set the minutes, am/pm, month, day, and year. The flashing field is the one you are changing.
5. Once you set the year, press and hold until the flashing test strip symbol appears.
6. See Chapter 4, Meter Setup to set other options.
Using ACCU-CHEK Aviva Test Strips
Only use ACCU-CHEK Aviva test strips. Using other test strips with this meter can produce inaccurate results. Replace the code key and run a control test every time you open a new box of test strips. See Chapter 2, Control Testing. Store the unused test strips in their original container. Do not remove test strips from the test strip container and put them into another container, such as a plastic bag, pocket, purse, wallet, etc. Close the container tightly right after you take a test strip out. This helps keep the test strips dry. Be sure to check the Use by date on the test strip container. Do not use the test strips after that date. See Chapter 5, Screen Messages and Troubleshooting for the error code for expired strip. If the Use by date is missing or cannot be read, do not use the test strips and call the ACCU-CHEK Customer Care Service Center at 1-800-858-8072. Chapter 1: Understanding Your New System 14 Use the test strip within three minutes after you take it out of the container. Store the test strips at 36 F to 90 F. Do not, freeze. Allow the test strips to warm to the operation temperature (43 F 111 F) prior to use. Do not apply blood or control solution to the test strip before you insert it into the meter. If the meter gives you a result before applying blood or control solution, do not act on that result. Do not reuse test strips. Once you have put control solution or blood on a test strip, discard it. If you need to retest, use a new test strip.

Inserting a Lancet Drum

You must first load the drum into the lancing device to get it ready for use.
1. Remove the cap by pulling it straight off. It is not a twist cap. The easiest way to do this is to place your thumb to the side of the notch as seen in the illustration.
2. Before you insert a drum, be sure that the release button is not yellow, and that no lancets are sticking out of the drum. Insert a new drum, blue ring first, until it stops. It clicks into place.
Chapter 3: Testing Your Blood Sugar
3. Slide the cap on until it stops by aligning the notch on the cap with the notch on the device.
4. You are now ready to use the first lancet. The lancet counter on the plunger shows five white bars, meaning you have five new lancets remaining.
Preparing the Lancing 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 lancing 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 depth selection. The higher the number, the deeper the penetration. If you have soft skin, we suggest starting at a depth of 2. If your skin is calloused or thick, try a higher setting. 27
3. Press the plunger in as far as it will go, like a pen.
4. The release button turns yellow. Do not press the release button while pressing the plunger. Set the lancing device aside until later in the test.
Running a Blood Sugar Test with Blood from Your Fingertip
Before 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 lancing device with a drum loaded to run a blood test.
1. To make sure the display is working 2. Wash your hands with warm soapy 5. Make sure the code number on properly, turn off the meter, then water and dry thoroughly. Dirty or the display matches the code press and hold to see the wet hands could affect results. number on the test strip complete display. All segments container. If you miss seeing the 3. Prepare the lancing device. should be clear and look exactly like 4. Insert the test strip into the meter code number, remove the test the picture. If any segments are strip and reinsert it into the in the direction of the arrows. The missing from the display, there may meter. meter turns on. be a problem with the meter. Call the ACCU-CHEK Customer Care Service Center at 1-800-858-8072.

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

Yellow release button

6. When the blood drop symbol 7. Hold the lancing device firmly flashes, obtain a drop of blood from against the side of your fingertip. your fingertip. Remember that the opening where the lancet comes out is not in the center of the cap. Press the yellow release button. Make sure that each lancet is fully retracted after use. Chapter 3: Testing Your Blood Sugar 30
8. Gently squeeze your finger to assist the flow of blood. This helps you get a blood drop. Touch the drop to the tip of the yellow window of the test strip. Do not put blood on top of the test strip.
9. 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.
10. The result appears on the display. If you want to flag your test result for a special event, leave the test strip in the meter. See Chapter 3, Flagging Test Results. Otherwise, throw the used test strip away.
If mg/dL does not appear with the test result call the ACCU-CHEK Customer Care Service Center at 1-800-858-8072. Use of the wrong unit of measure may cause misinterpretation of your actual blood glucose level, and may lead to incorrect treatment.
Note: Do not twist the plunger when the release button is yellow or when the lancet counter shows no white bars. This may damage the device.
11. For virtually pain-free testing, we recommend that you 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 it back all the way.
12. 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.

Changing the Lancet Drum

When you have used the sixth and last lancet, you should change the drum.
1. Take the blue cap off the lancing device by pulling it straight off. It is not a twist cap. The easiest way to do this is to place your thumb to the side of the notch as seen in the illustration. Chapter 3: Testing Your Blood Sugar 33
2. Hold the drum between your thumb and index finger and pull it straight out of the lancing device. Two red stripes are visible on the white part, indicating that the drum has been used.
Notes: A used drum cannot be reinserted into the lancing device. If the ACCU-CHEK Multiclix lancing 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 end and dispose in a sharps container.
3. Throw the old drum away. Always dispose in accordance with local regulations.

4. Before you insert a drum, be sure that the release button is not yellow. Insert a new drum, blue ring first, until it stops. It clicks into place. 34