Brian Hill, Ph.D., brian.hill@roche.com Roche Diagnostics, 9115 Hague Road, Indianapolis, Indiana 46256 USA
Accu-Chek Advantage: Electrochemistry for Diabetes Management
This article discusses the electrochemical principles behind the Accu-Chek glucose meter.

Diabetes

When the body no longer produces insulin, or has a reduced sensitivity to it, diabetes is the result. In Indiana, over 338,000 people (7.4% of the population) have been diagnosed, and another 182,000 are thought to have unidentified diabetes. That is, roughly one in twelve Hoosiers has diabetes. The chronic elevated blood sugar which results from this condition causes long-term damage to numerous tissues and organs. The medical and financial costs to our state, summarized in a recent State Department of Health report (1), are staggering: " Diabetes has caused nearly 40% of end-stage renal disease in Indiana. " Diabetes has blinded 22,000 Hoosiers over age 40 and causes over 1,700 non-traumatic amputations each year in Indiana. " Diabetes roughly doubles a patients risk of death and contributes to over 5,000 deaths in Indiana each year. " Diabetes cost Indiana almost $4.5 billion in 2002. Much of this burden may be reduced or eliminated by early detection and improved self-care. The Diabetes Control and Complications Trial (DCCT) (2), a 10-year nationwide study of 1,441 diabetics, conclusively demonstrated that improved control of blood sugar delayed or prevented many of these complications at least 50% better than with poorly-controlled subjects. Subsequent studies have corroborated this conclusion. This good control is enabled by frequent, consistent and accurate self-testing of blood glucose to optimize therapy.
Accu-Chek Advantage meets these needs by providing accurate and dependable glucose measurement using a tiny drop of blood, for all blood sample types (capillary, arterial, venous and neonatal) over a wide range of hematocrit. It delivers this performance in a matter of seconds at temperatures from 57 to 104 F, and at altitudes to above 10,000 feet. More patients and hospitals worldwide rely on Accu-Chek Advantage than any other glucose measurement system.
How Does the Hand-held Electrochemical System Work? Accu-ChekAdvantage technology uses two components:

Electronic Meter

(measurement, storage and communication device)

Disposable Biosensor

(sample measurement reaction site)

Accu-Chek Advantage

There are several essential elements in a medical device designed for patient self-monitoring. Because these systems are medical devices, used to make medical decisions or avoid potentially life-threatening incidents every day, they must be of very high quality, and the information displayed must be accurate. The sensors must be easily manipulated by sightimpaired users, and the system must be very user-friendly to encourage more frequent testing for better control. In the hospital or physicians office there are additional quality requirements, and the possibility of multiple sample types (e.g., capillary, arterial, venous and neonatal blood).
" Applies potential differences in a programmed sequence to the sensor " Collects biamperometric current data " Records and displays results
" Collects the blood sample " Sample undergoes an enzymatic chemical reaction followed by: " An electrochemical reaction
The patient simply inserts a biosensor into the meter and applies a small drop of blood.
Electrochemistry Basic Principles
Lets begin with basic electrical definitions and concepts and assemble them into a simplified description of the measurement method.

Current Separations

" Current: The rate of electron movement or charge transfer. This is analogous to water flow in a pipe (e.g., gallons per hour for water, amperes for current). " Potential: If current is flow rate, potential is pressure (e.g., pounds per square inch for water, volts for potential). A potential difference represents a difference in the average electron energy at two points. Just as water will flow if a pressure difference exists between two points in a pipe, current will flow if a potential difference exists between two points in a conductor. Similarly, as flow increases with pressure in a pipe, current increases in a conductor as the potential difference is increased. " Electrochemistry Well limit this discussion to particular chemical and electrical interactions between two phases: a chemically inert, electrical conductor (electrode) and a liquid ionic conductor (electrolyte or sample) where chemical reactions occur. " Electrode Although electron energy in ions or molecules is determined by chemical structure, the energy of electrons in an electrode may be easily changed by adjusting the electrode potential. There are two common methods for controlling electrode potential: 1. Electronically using a meter or potentiostat. 2. Chemically. If an electrode can match its electron energy with ions in solution, those ions may define the electrode potential. The Nernst equation defines this relationship.

" Blood is a complex fluid and glucose levels vary widely over time in a single patient. " Many factors besides glucose vary in blood from healthy patients (e.g., hematocrit, oxygen levels, metabolic byproducts, etc.). " Patients with diabetes may have a wide range of other medical problems creating even greater variation in their blood. " Enzymes permit chemical reactions to occur at much faster rates without requiring major modifications to the biological sample (e.g., increased temperature or pressure, dramatic pH changes, addition of highly reactive chemicals, etc.). Unfortunately, enzymes rarely exchange electrons directly with electrodes. The same is true for many other biological molecules, such as glucose. An electrochemical measurement often requires a substance to facilitate (or mediate) this transfer, and such reagents are termed mediators.
Mediators A well-known mediator is potassium ferricyanide. The reaction process is: a) Glucose first reacts with the enzyme glucose dehyrogenase. Glucose is oxidized to gluconic acid and the enzyme is temporarily reduced by two electrons transferred from glucose to the enzyme. b) The reduced enzyme next reacts with Mox, transferring a single electron to each of two mediator ions. The enzyme is returned to its original state, and the two Mox are reduced to Mred:
gluconic acid glucose dehydrogenase 2 ferrocyanide (Mred ) +2H+ 2 ferricyanide (Mox)
ElectronTransfer Reactions Consider the reduction (electron addition) of potassium ferricyanide (Mox) to potassium ferrocyanide (Mred). This is a simple electron transfer reaction:
(shorthand) Fe(CN)63- + e- Fe(CN)64Mox + e- Mred

glucose

Since Mox and Mred each have different electron energies, we use the Nernst equation to define the solution potential (the average energy of electrons in the solution): 0.059 [Mox] log E = E0 + n [Mred]
E = solution potential E0 = formal potential (potential under standardized conditions, [Mox] = [Mred]) [Mox] = concentration of Mox; [Mred] = concentration of Mred n = number of electrons exchanged in redox reaction (in this case, n = 1) [M ] log [M ox ] = base 10 logarithm of the concentration ratio

c) Ferricyanide and ferrocyanide are capable of rapidly transferring electrons with an electrode. The electrons may thus be transferred between glucose and the electrode via enzyme and mediator. Now we have a chemical mechanism for transferring electrons from glucose to the electrode. The biosensor reagent is actually more complex, containing a number of other active ingredients (e.g., stabilizers, processing aids, etc.), but well view it as composed of simply the enzyme and mediator. How is the electrochemical measurement performed?

Amperometry

An extremely useful method is amperometry. This technique sets the electrode potential at a level where every molecule or ion reaching the electrode surface immediately undergoes an electron transfer reaction. The current (rate of electron transfer) is thus limited by how rapidly the reactants arrive a diffusion-controlled current, since diffusion is the primary transport mechanism. Because reactant is being converted (consumed) at the electrode surface, its average concentration will be decreasing in the vicinity of the electrode, so current should decrease with time. We wont go into detail, but the Cottrell equation describes this behavior.

Enzyme Reactions

Enzymes are protein catalysts which accelerate specific chemical reactions. In the plumbing metaphor, enzymes increase pipe diameter by removing a blockage; instead of water trickling past the blockage, it may now flow freely. Enzymes are often highly specific, and this specificity enables organisms to manage a single type of molecule among tens of thousands within a cell or organ. Enzymes offer powerful advantages for biological analysis.
www.currentseparations.com
Cottrell equation: I = (n FA D1/2 C) / (p t)1/2
I = current, in amps n = number of electrons transferred in the reaction (for ferrocyanide, n = 1) F = Faraday constant (the quantity of charge carried by 1 mole of electrons = 96,485 Coulombs/mol) A = electrode area (cm2) D = diffusion coefficient (a measure of how rapidly reactant is transported; for ferrocyanide the diffusion coefficient is ~ 7 x 10-6 cm2/sec at room temperature) C = concentration of reactant (mol/cm3), the model assumes uniform concentration before potential difference applied t = time (seconds)
electron flow rate into the other (counter electrode). " If we oxidize ferrocyanide to measure glucose at the working electrode, we must reduce an equal quantity of something else at the counter electrode. Since we already have ferricyanide in the reagent, this is our best choice. " In biamperometry, the two electrodes are identical. (Accu-Chek Advantage uses palladium electrodes, a noble metal similar to platinum.)

Its easier to visualize this effect if we examine diagrams of the concentration and current changes with time.

Concentration (mol/cm3)

Initial Concentration (C0 at t0)
The Measurement Sequence Itself Consists of Five Time Segments 1. When biosensor is inserted, the meter automatically turns on and performs a series of tests. 2. After all tests are successfully completed, the meter applies a potential difference to detect sample (Drop Detect). 3. Following sample application (Drop Detect), electrode potential difference is removed and enzymatic reaction is permitted to proceed (Incubation Period). 4. After Incubation Period, the meter applies a potential difference and measures current (Measurement Period). 5. Current data are analyzed, the result is recorded and displayed. Measurement Sequence Diagram

Applied Potential (mV)

0 = Electrode Surface
Distance from Electrode Surface (cm)

Drop Detect

Current vs. Time

Current (microamps)

Incubation Period

Measurement Period

Time (s)
" Incubation period: After Drop Detect, glucose dehydrogenase catalyzes a selective electron-transfer reaction between glucose in the sample and Mox (potassium ferricyanide) in the reagent layer:
Time after applied potential (seconds)
" Initially (t0), the reactant has a uniform concentration C0. " When the potential difference is applied, reactant concentration at the electrode surface goes to zero. Over time (t1 t2, t3), consumption of the reactant decreases its concentration, creating a diffusion layer. " The result is a current decreasing with the square root of time.
Putting the Pieces Together
Reviewing The Measurement System Components " An enzyme (glucose dehydrogenase) rapidly transfers electrons from glucose to a mediator, which may transfer them to an electrode. " An electrode potential is imposed on the system. " In any circuit, current must be identical at all points. If we put two electrodes in a circuit, electron flow rate out of one electrode (working electrode) has to equal the
Each molecule of glucose reduces two molecules of ferricyanide, creating two molecules of ferrocyanide. The final ferrocyanide concentration is directly correlated to the sample glucose concentration. " Measurement period: During the measurement period, the meter applies a potential difference between the working and counter electrodes. The counter electrode potential is defined by the ratio of ferricyanide and ferrocyanide at the electrode surface: 0.059 [Mox] log E = E0 + n [Mred] Since the amount of ferrocyanide is small relative to the amount of ferricyanide, the concentration ratio (and hence the

Current (A)

counter electrode potential) is effectively constant. This applied potential difference is sufficient to provide a diffusion-limited current at the working electrode, so the ferrocyanide concentration may be determined by biamperometry. The meter measures working electrode current, which is linked to ferrocyanide concentration by the Cottrell equation. Because the ferrocyanide concentration is coupled to glucose concentration, the current measurement permits calculation of blood glucose.
eFe(CN)3- + e- + K + 6 Fe(CN)4- + K + 6
(Counter electrode reduction of ferricyanide)

(Meter)

(In solution, charge balance is maintained via ion transport.)

Fe(CN)4- + K + 6

Fe(CN)3- + K + + e 6
(Working electrode oxidation of ferrocyanide)
" Because of this, the instrument is a medical management tool improving the lives of millions of diabetes patients across the world. " Accu-Chek Advantage delivers remarkable performance with a wide range of sample types and conditions, performing tens of millions of measurements each year: Glucose measurement range: 10-600 mg/dL Temperature: 10 - 40C Hematocrit: 20-65% for glucose < 200 mg/dL; 20 - 55% for glucose > 200 mg/dL Humidity: up to 85% RH Altitude: up to 10,150 feet Samples: venous, arterial, finger stick capillary, neonate Typical within-lot precision: SD/CV ~ 2 mg/dL or 2% " As electronic technology evolves, so do electrochemical measurement systems. The latest Accu-Chek Aviva (currently pending U.S. Food and Drug Administration 510(k) clearance) will be available soon.

Conclusion

" Accu-Chek Advantage illustrates many fundamental chemical and electrochemical reaction concepts. Although weve only skimmed the science and engineering considerations, the system illustrates elements of enzymatic and charge transfer reactions, potentiometry, amperometry and diffusion. " By carefully optimizing a design based on fundamental principles, this handheld device provides a robust electrochemical system for blood glucose measurement.

References

1. The Burden of Diabetes in Indiana, Ind. State Dept. of Health Diabetes Prevention and Control Prog., April 5, 2004. 2. The Diabetes Control and Complications Trial Research Group, New England J. Med. 329, 977 (1993).

362_24016_Manual_AC_ADV3_Dom

1/28/05

10:16 AM

Page 1

362-24016 03508501003
All images/graphics are 4/C process throughout manual. All unspecified prints black throughout manual. Advantage prints 100c, 69m, 11k.

Owners Booklet

Roche prints 100C, 52M. NOTE: This document may not view or print at actual size.

Page 2

Dear ACCU-CHEK S
Thank you for choosing the

Inside front cover

Congratulations on your de ACCU-CHEK Advantage sys living with diabetes a little
This booklet will help you g you to visit www.accu-ch you manage your diabetes
To start testing quickly, you
If you have questions, wer toll-free at 1-800-858-807 and many other languages
Thanks again for choosing
Dear ACCU-CHEK System Owner,
Thank you for choosing the ACCU-CHEK Advantage system! Congratulations on your decision to take control of your diabetes. Weve designed your new ACCU-CHEK Advantage system 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 Advantage system. We also invite you to visit www.accu-chek.com to find out about services, tools, and information that can help you manage your diabetes. To start testing quickly, you can also refer to the First Time Guide or the Quick Reference Guide. If you have questions, were here to help. Just call the ACCU-CHEK Customer Care service center toll-free at 1-800-858-8072. We offer assistance 24 hours a day, 365 days a year, in Spanish and many other languages. Thanks again for choosing an ACCU-CHEK system.
ACCU-CHEK. and bullets on page print 100c, 69m, 11k. d art at bottom of pages 2 and 3 s 100c, 69m, 11k to white.
The ACCU-CHEK Advantage System*
Your new ACCU-CHEK Advantage meter and accessories work together to measure the amount of sugar (glucose) in your blood to help you and your doctor control your diabetes. The system includes: ACCU-CHEK Advantage Meter ACCU-CHEK Comfort Curve Control Solution* Battery ACCU-CHEK Comfort Curve Test Strips* ACCU-CHEK Softclix Lancets* ACCU-CHEK Softclix Lancet Device* Code key *Items may be sold separately.

Important Informatio

Your blood glucose meter blood taken from fingertips diabetes. Be sure to use only ACCUmeter. Other test strips ma Do the control tests explai Carefully dispose of used t
Why Regular Blood Sugar Testing Is Important
Checking your blood sugar can make a big difference in how well you can manage your diabetes on a daily basis. Weve made it as simple and comfortable as possible. ACCU-CHEK meters are easy to use, and you can adjust the ACCU-CHEK Softclix lancet device to make testing more comfortable.

Health-Related Infor

Being severely dehydrated suffering from dehydration If you have followed all the your test results or if you

Need Help?

Just call the ACCU-CHEK Customer Care service center, 24 hours a day, 365 days a year, at 1-800-858-8072. You can also visit www.accu-chek.com for diabetes management tools and product demonstrations. To make sure you receive the best customer service possible and news about product updates, please complete and mail your warranty card.
ACCU-CHEK Customer Care Service Center 1-800-858-8072

Page 3

Important Information About Your New Meter
e the amount of sugar em includes: ntrol Solution* st Strips* evice* Your blood glucose meter is designed and approved for testing fresh capillary whole blood samples (like blood taken from fingertips) outside the body (in vitro diagnostic use). It should not be used to diagnose diabetes. Be sure to use only ACCU-CHEK Comfort Curve test strips or ACCU-CHEK Advantage test strips with the meter. Other test strips may produce inaccurate results. Do the control tests explained in this booklet to make sure your system is working properly. Carefully dispose of used test strips and lancets.

Health-Related Information
e your diabetes on a daily re easy to use, and you e. a year, at ent tools and product news about product Being severely dehydrated or losing a lot of water may give you false (low) test results. If you think youre suffering from dehydration, call your doctor right away. If you have followed all the instructions in this booklet and still have symptoms that dont seem to match your test results or if you have questions talk to your doctor.
e Service Center 1-800-858-8072

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ontents prints 100c, 69m, 11k. end art at bottom of page prints 100c, m, 11k. to white with Contents versed-out white. hapter 1. reverses-out white of the p most blend of 100c, 30m, 6k. to hite.

Contents

Chapter 1: Understanding Your New System..6 Installing (or Changing) the Battery...8 Setting the Time and Date....9 Setting the Beeper...11 Setting the Hypoglycemic (Hypo) Indicator..12 Coding the Meter....13 Using Your Test Strips...14 Using ACCU-CHEK Comfort Curve Test Strips..15 Using ACCU-CHEK Advantage Test Strips...15 Chapter 2: Control Testing....16 Why Run Control Tests....16 About the Control Solution...16 Running a Control Test...17 Understanding Control Test Results..19 Chapter 3: Testing Your Blood Sugar..21 Preparing the ACCU-CHEK Softclix Lancet Device..21 Running a Blood Sugar Test...23 Flagging Test Results...25 Recording Your Results...25

Contents 4

Storing Your Su Proper Testing C Understanding Y

Chapter 4: Using

Storing Test Res Viewing Test Re Downloading Yo

Chapter 5: Mainte

Cleaning Your M Maintenance an Cleaning Your L Screen Messag

Chapter 6: Techn

hapter 2. reverses-out white of the ddle blend of 100m, 43y, 18k. to hite. hapter 3. reverses-out white of the xt-to-bottom blend of 27m, 100y, 6k. white.
Product Limitat Specifications. Product Safety Warranty. Money-Back Gu Additional Supp Information for Index. Contents

Page 5

.6.8.9..11..12..13..14..15..15..16..16..16..17..19..21..21..23..25..25
Storing Your Supplies....25 Proper Testing Conditions...26 Understanding Your Test Results...26
Chapter 4. reverses-out white of the most blend of 65c, 100m, 15k. to white. Chapter 5. reverses-out white of the middle blend of 100c, 47y, 30k. to white
Chapter 4: Using Your Meters Memory...28
Storing Test Results...28 Viewing Test Results....28 Downloading Your Meter to a Computer....29
Chapter 5: Maintenance and Troubleshooting...30
Cleaning Your Meter....30 Maintenance and Testing....31 Cleaning Your Lancet Device....31 Screen Messages and Troubleshooting...32
Chapter 6: Technical Information...36
Product Limitations...36 Specifications....36 Product Safety Information...37 Warranty....38 Money-Back Guarantee....39 Additional Supplies...42 Information for Professional Caregivers...43 Index....44 Contents 5

Chapter 6. reverses-out white of the next-to-bottom blend of , 44k. to white. Blend art at bottom of page prints 100c, 69m, 11k. to white with Contents reversed-out white.

Page 6

Chapter 1:. is black on a blend of 100c, 30m, 6k. to white.
Chapter 1: Understanding Your New System*
Display Shows blood sugar results, messages, and results stored in memory. Left and Right Arrow Buttons Press to enter memory, adjust settings and scroll through results. On/Off Button Press this button to turn the meter on or off. Computer Port
Arrows with lines print 50k throughout manual.
Test Strip Slot Insert test strip here. Battery Cover Push tab in direction of arrow to remove cover and replace battery.
Code Key in Slot Insert code key through this opening.

Test Strip Vial

Cap wit Dept
*Items may be sold separately.

Page 7

ystem*

Silver-colored bars

Computer Port

Protective Cover

Yellow Window
Code Key in Slot Insert code key through this opening. Test Strip Vial Test Strip Lancet
Cap with Comfort Dial Depth Selection

Release Button

Ejector

Lancet Device

Plunger

Page 8

Installing (or Changing). prints 100c, 30m, 6k.
Installing (or Changing) the Battery
1. Flip open the battery cover by pushing tab toward arrow. 2. Insert the battery with the plus (+) side up or facing you. 3. Replace the battery cover and snap it closed.

Setting the Tim

Setting the time and date is i
Blend in center prints 20c, 6m,1k throughout Chapter 1.

Notes:

The meter uses a 3-volt lithium battery. It is best to use a longlasting lithium battery and to keep an extra on hand. Be sure the battery goes in plus-side up or facing you. Your meter will prompt you to verify the time and date immediately after the battery is inserted. This occurs only if the time and date has been set previously on your meter. If there is no strip in the meter, it turns off automatically after 90 seconds. Chapter 1: Understanding Your New System 8 The battery symbol means the battery is low and should be changed soon. A flashing battery symbol means the battery is almost out of power and must be changed to do a blood test.

Blend at bottom prints 100c, 30m, 6k to white with Chapter 1:. reversing-out white throughout remainder of Chapter 1.
Chapter 1: Understanding Y

Page 9

Setting the Time and Date
Setting the time and date is important if you use the meters memory or connect to a computer.
Setting the Time, Date,. prints 100c, 30m, 6k. Graphics of buttons in copy print 4/c throughout manual.
1. Press and release (On/Off button) to turn on the meter. Wait for the flashing test strip or ---. 2. Press and hold until set appears, and then release it. The word On and the beeper symbol appear. 3. Press and release to see the hour flash in the upper left corner.
battery symbol means the ery is low and should be nged soon. ashing battery symbol means battery is almost out of power must be changed to do a d test.
Chapter 1: Understanding Your New System

Page 10

4. Press and release either or (left or right arrow button) to change the hour. 5. Repeat steps 3 and 4 to set the minutes, month, day and year. (The flashing number is the one that can be changed.) 6. Press and hold down to finish setup. The flashing test strip appears.

Setting the Be

When you first get your m results in any way). It be A strip is inserted.

Blood or control solu

A result is displayed

To turn

1. Pres or -

2. Pres butto 3. Pres

4. Pres appe Chapter 1: Understanding Your New System 10

Page 11

Setting the Beeper
When you first get your meter, the beeper is set to On (but you can turn it off and not affect your test results in any way). It beeps whenever: A strip is inserted. An error occurs while testing. The beeper sounds when an error occurs, even if the Blood or control solution is applied to a strip. beeper is turned off. A result is displayed. Buttons are pushed.
Setting the Beeper, prints 100c, 30m, 6k.

To turn the beeper off:

1. Press and release or --- to appear. to turn on the meter. Wait for the flashing test strip
2. Press and hold down until set appears on the display, then release the button. The word On and the beeper symbol appear. 3. Press and release either 4. Press and hold down appears or ---.

to turn the beeper off.

until set disappears. The flashing test strip

Page 12

Setting the Hypo. prints 100c, 30m, 6k.
Setting the Hypoglycemic (Hypo) Indicator

You may set the meter to warn you when your results indicate hypoglycemia (low blood sugar) anywhere between 60-80 mg/dL. Before you set the hypoglycemic indicator, ask your healthcare professional to help you decide what level is best for you. New meters have the hypo indicator turned off by default. To turn on and set the hypo indicator: 1. Press and release to turn on the meter. Wait for the flashing test strip or ---. 2. Press and hold until set appears on the display, then release. The word On and the beeper symbol will appear. 3. Press repeatedly until Hypo flashes and OFF and set appear. 4. Press and release either turn on the hypo indicator. 5. Press and release. or to

Coding the Me

Change the co
6. Press and release or to adjust the hypo indicator. Hypo will flash for results at or below the number you choose. 7. Press and hold down until set disappears and the flashing test strip or --- appears.
4. Chapter 1: Understanding Your New System 12

Page 13

ow blood sugar) anywhere r healthcare professional dicator turned off by lease either ypo indicator. lease. or to

Coding the Meter

Coding the Meter prints 100c, 30m, 6k. Blend behind warning icon prints 27m, 100y, 6k, with triangle warning icon printing 100m, 43y, 18k. with ! reversed-out white. This blend and the warning Icon appear together throughout the manual.
Change the code key every time you open a new box of test strips.
1. With the meter off, slide the code key into the code key slot. It should easily snap into place.
If --- appears on the display, turn off the meter, make sure the code key is all the way in, then turn on the meter again. Dont force the code key into the meter: it only goes in one way - numbers out and ridges up. If the code number on the display does not match the code number on the test strip vial, call the ACCU-CHEK Customer Care service center at 1-800-858-8072.
lease or to po indicator. Hypo will ults at or below the number old down until set nd the flashing test strip or s.
2. Press and release the meter on.

Example and

Level 2 Testing
Level 1 testing is all you need to do most of the time. If you think your meter or strips may not be working correctly, you may also want to do a Level 2 test. Simply repeat Steps 3 through 6, using Level 2 control solution. If you do not have Level 2 control solution, you can purchase control solutions separately.

Page 19

Understanding Control Test Results
s the test result then OK, r does not show OK, see
Level 1 (LO) Level 2 (HI) Range (mg/dL) 4272 290328
Understanding Control Test. prints 100m, 43y, 18k.

esults on page 19.

When a control test result is within the acceptable range, your test strips and meter are working properly. The label on your test strip vial shows the acceptable ranges for Level 1 and Level 2 test solutions. Your control test results should be within the listed range. You can compare the result to the range for the level of control solution you used (Level 1 or Level 2). If the control result is within the acceptable range, the control test result will alternate with OK on the display. If the control result is NOT within the acceptable range, the control test result will alternate with Err on the display. See the following page to find out why your control result is out of range.
ips may not be working using Level 2 control arately. and

Page 20

Chapter 3: Tes
Blend behind left side of chart prints 20m, 9y, 4k to white.

Troubleshooting Checks

1. Check the expiration dates of the test strips and control solutions. 2. Make sure the caps were tight on the test strip vial and control solution bottles. 3. Check if the code on the meter matches the code on the test strip vial. 4. Make sure you followed all the testing steps. 5. Make sure the temperature was between 57 to 104F (14 to 40C) when you did the test. 6. If none of the above apply.

Action

Replace solution or strips that have expired or solution you opened more than three months ago. If either has been open for a while, replace the test strips or control solution. If not, recode the meter (see page 13). Reread pages 16-18 and test again or ask your healthcare provider for help. Repeat the test within the appropriate temperature range. Repeat the control test with a new test strip. If the result still isnt within the acceptable range, contact the ACCU-CHEK Customer Care service center at 1-800-858-8072. 20

Preparing the ACCU

1. Pull off the cap.
Note: You can refer to the F

Page 21

Running a Blood. prints 27m, 100y, 6k.
hat lets you get enough e one thats right for you. ur lancet device
5. When you see the flashing blood drop, hold the lancet device against the side of your fingertip and press the release button.

Page 24

6. Gently squeeze your fingertip until you get a drop of blood. 7. Touch and hold the blood drop to the edge not the top of the yellow window. Make sure the yellow window fills completely. If you still see yellow, apply another drop of blood within 15 seconds or start over with a new test strip. 8. An hourglass flashes on the screen, and the test result appears. 9. To remove the lancet, take off the lancet device cap and point the lancet end away from yourself. 10. Slide out the ejector to discharge the lancet into a puncture-proof container. For more information about your test results, see page 25.

Flagging Test R

To help you remember specific mark those results. 1. Perform a blood test. 2. While a test result is dis. An asterisk appears

Recording You

Always record your blood su patterns in your blood sugar chances for complications. R

Storing Your Su

Make sure you close the test You can keep all your testing where it wont be exposed to
Chapter 3: Testing Your Blood Sugar 24
Never store te bathroom or la

Page 25

til you get a drop of blood. o the edge not the top e the yellow window fills her drop of blood with a new test strip. een, and the test result e lancet device cap and yourself. e the lancet into a our test results,

Flagging Test Results

To help you remember specific events that might have influenced your results, you can add a flag an asterisk to mark those results. 1. Perform a blood test. or 2. While a test result is displayed and the test strip is still in the meter, press and release either. An asterisk appears on the display in the lower-right corner.
Flagging Test. ,Recording your. , and Storing your., print 27m, 100y, 6k.

Recording Your Results

Always record your blood sugar results after testing. This helps you and your healthcare professional find patterns in your blood sugar results. This information helps you better manage your diabetes, reducing your chances for complications. Record your results in the self-test diary included in your kit or on your computer.

Storing Your Supplies

Make sure you close the test strip vial and control solution bottles tightly after each use. You can keep all your testing supplies in the carrying case. Store the carrying case (and everything in it) where it wont be exposed to heat or moisture. Your bedroom may be a good place.

Page 26

Proper Testing. and Understanding your. print 27m, 100y, 6k.
Proper Testing Conditions
The temperature range must be between 57 to 104F (14 to 40C). At temperatures outside this range, the results are displayed with a thermometer symbol. Humidity must be below 85% so that moisture doesnt condense on or inside the meter. Let the meter return to room temperature and thoroughly dry before turning it on.

Symptoms of H

Being aware of the symptom decide what to do if they see
High blood sugar (hyperglyce headache, or general aching
Understanding Your Test Results
Normal Blood Sugar Ranges
The normal fasting blood glucose range for an adult without diabetes is 74106 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.
Low blood sugar (hypoglycem around mouth or fingertips.
If you are experiencing any or HI, contact your doctor i

Unusual Test R

If your blood sugar result doe 1. Run a control test (see 2. Repeat a blood sugar 3. If your blood sugar res

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Symptoms of High or Low Blood Sugar
ures outside this range, e meter. n. 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. Here are the most common symptoms: High blood sugar (hyperglycemia): fatigue, increased appetite or thirst, frequent urination, blurred vision, headache, or general aching. Low blood sugar (hypoglycemia): sweating, trembling, blurred vision, rapid heartbeat, tingling, or numbness around mouth or fingertips. If you are experiencing any of these symptoms, test your blood sugar. If your result is displayed as LO or HI, contact your doctor immediately. g/dL.1 ss than 140 mg/dL.2 ppropriate for you.
Symptoms of. and Unusual Test. print 27m, 100y, 6k.

Unusual Test Results

If your blood sugar result doesnt match the way you feel, follow these steps: 1. Run a control test (see page 16). 2. Repeat a blood sugar test (see page 21). 3. If your blood sugar results still dont reflect the way you feel, call your doctor immediately.

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Chapter 4:. is black on a blend of 65c, 100m, 15k to white.
Chapter 4: Using Your Meters Memory

Storing Test Results

Your meter automatically stores up to 480 test results, and you can review them at any time. If youve set the time and date on the meter (see page 9), this information is stored and displayed with your test results. If you havent, test results are simply stored in order, from the newest to the oldest. The meter can also display 7, 14, and 30-day averages.

Most Recent Result

Storing Test results. and Viewing test. print 65c, 100m, 15k.

Viewing Test Results

Press and release either or (left or right arrow button) to enter the meters memory. If a code key is installed, the code number appears briefly, followed by the most recent test result stored in the memory. If no code key is installed, code and --- appear. Press and release either or again to enter the memory and view the most recent test result.
Do not change your thera Results stored in memor be prompted to verify tim Once 480 results are in to be deleted.

Downloading Y

Two bold arrows pointing downward to the left/right and vertical rule between screen shots print 100c, 69m, 11k.
to view previous individual results, or
to view in order 7, 14, and 30-day

averages respectively.

You can transfer your stored We offer a variety of software computer or PDA. For a list o Customer Care service cente for more information.

And so on

Third Most Recent Result
Second Most Recent Result

7-Day Average

14-Day Average

30-Day Average

DO NOT RUN A COMPUTER OR USE ONLY ACC DATA PORT.
Chapter 4: Using Your Mete

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se either or (left or right
Do not change your therapy based on an individual result recorded in memory. Results stored in memory will not be lost when you replace the battery, but you will be prompted to verify time and date if previously set. Once 480 results are in memory, adding a new test result causes the oldest one to be deleted.

Maintenance and. and Cleaning your lancet. prints 100c, 47y, 30k.
he code key slot or test lution directly onto the water (or any liquid). eter.
Cleaning Your Lancet Device
To clean the ACCU-CHEK Softclix lancet device, use a mild dishwashing liquid and a soft cloth. DO NOT place the entire device under water. At least once a week, disinfect the cap after cleaning by placing it in 70% alcohol (isopropyl) for 10 minutes. Allow the cap to air-dry after disinfecting. Chapter 5: Maintenance and Troubleshooting 31
Blend at bottom prints 100c, 47y, 30k to white, with Chapter 5:. reversed-out to white throughout remainder of chapter 5.

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Screen Messages. prints 100c, 47y, 30k.
Screen Messages and Troubleshooting

Battery pow battery soo

Never make treatment decisions based on an error message. If you have any concerns, please call the ACCU-CHEK Customer Care service center at 1-800-858-8072, 24 hours a day, 365 days a year.
The meter isnt coded or the code key isnt all the way in. Turn off the meter and recode it. See page 13. The meter is in set mode, waiting for you to change settings. See pages 9-11. The meter is ready for you to put in a test strip.
The meter is ready for a drop of blood to be put on the strip.

Battery is a Change the

The meter is ready for a Level 1 control test. See page 16.
Blood suga measuring See pages
The meter is ready for a Level 2 control test. See page 16.

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Battery power is low. Change the battery soon.
any concerns, please call rs a day, 365 days a year.
Your blood sugar result is below your defined hypo (low blood sugar) level.
r is ready for a drop of be put on the strip.
Battery is almost out of power. Change the battery now.
r is ready for a Level 1 st. See page 16.
Blood sugar is higher than the measuring range of the system. See pages 2627. Blood sugar is lower than the measuring range of the system. See pages 2627.
The meter is being operated outside of the appropriate temperature range. Move to an area where the temperature is appropriate for running a test, wait five minutes and repeat the test. Do not artificially heat or cool the meter. Refer to the test strip package insert for temperature ranges appropriate for the operation of your system. This test result may not be accurate because the test was performed outside the operating temperature range of the system.
r is ready for a Level 2 st. See page 16.

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This test result was flagged. See page 25.
The code key is faulty or was removed while the meter was on. Turn off the meter and reinsert the code key. If this doesnt fix the problem, call the ACCU-CHEK Customer Care service center at 1-800-858-8072.

Some states do not allow limitat consequential damages, so the a legal rights, which vary from sta

We offer a 30-day mo

Money-back offer conditions prescriptions reimbursed by, a t affected by this exclusion may i

Non-Warranty Service

Roche Diagnostics Non-Warran has become inapplicable, or has charge (not to exceed $35). Rep for a period of 90 days from shi

Warranty and Service

All requests for return of ACCU-C ACCU-CHEK Customer Care serv which must be affixed to your c will be returned to you at your e
Customers experiencing difficult Further inquiries should be direc
Be sure to fill out and mail the

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Warranty
HEK Advantage meter will hase. If, during this 3-year anship, Roche Diagnostics charge. The warranty of 0 days after the shipment edy with respect to the meter that has been n any way. Roche n-Warranty Service Policy DIAGNOSTICS MAKES NO HE IMPLIED WARRANTY SHALL ROCHE INCIDENTAL, IN ANY WAY CONNECTED TY OF MERCHANTABILITY F THE METER, SHALL CHASE.
Some states do not allow limitations on how long an implied warranty will last or the exclusion of incidental or consequential damages, so the above elimination and exclusion may not apply to you. This warranty gives you specific legal rights, which vary from state to state.
We offer a 30-day money-back guarantee and a 3-year warranty
Money-back offer conditions and exceptions: This money-back offer is void for persons enrolled in, or for any prescriptions reimbursed by, a third-party payer including public (e.g. Medicare/Medicaid) and private payers. Consumers affected by this exclusion may instead request a different ACCU-CHEK meter/system.
Non-Warranty Service Policy
Roche Diagnostics Non-Warranty Service Policy applies to meters where the above warranty has not become effective, has become inapplicable, or has expired. Roche Diagnostics will replace at its option meters returned to it for a service charge (not to exceed $35). Replacement will be with the same or similar product. Replacement meters will be warranted for a period of 90 days from shipment under a limited warranty providing for replacement of parts and labor at no charge.
Warranty and Service Instructions
All requests for return of ACCU-CHEK Advantage meters under the above warranty or service policy must be made to the ACCU-CHEK Customer Care service center by calling 1-800-858-8072. You will be mailed a return authorization label, which must be affixed to your carton for 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 beginning on page 30 of this booklet. Further inquiries should be directed to the ACCU-CHEK Customer Care service center at 1-800-858-8072. Be sure to fill out and mail the warranty card that comes with the ACCU-CHEK Advantage system.

then this restricted license applies regardless of any additional offers found in ACCU-CHEK Advantage or ACCU-CHEK Comfort Curve test strip packages. If you do not agree to the terms and conditions of the restricted license, you may return, at the place of purchase, the unused ACCU-CHEK Advantage system 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 Advantage system are voided by use of the ACCU-CHEK Advantage system with any test strip or code keys other than ACCU-CHEK Advantage or ACCU-CHEK Comfort Curve test strips or code keys.
This product is covered by one or more of the following U.S. Patent Nos. 4,999,632; 4,999,582; 4,963,814; 5,508,171; 5,352,351; 5,405,511; 5,438,271; 5,997,817; 6,254,736; 6,270,637 (the latter three patents covering ACCU-CHEK Comfort Curve test strips); 5,288,636; 5,627,075; 4,891,319; 5,762,770 (when used with ACCU-CHEK Advantage test strips); 5,053,199; Re. 36,268 (when used with ACCU-CHEK Comfort Curve test strips); and 5,366,609. U.S. Patent No. 4,891,319 is licensed from Quadrant Holdings Cambridge Limited. The ACCU-CHEK Softclix lancet device is covered by U.S. Patent Nos. 4,924,879 and Re. 35,803.

Page 42

Additional Supplies
The following supplies and accessories are available from diabetes healthcare centers, pharmacies, or medical/surgical supply dealers:

Information for

Test Strips
ACCU-CHEK Comfort Curve Test Strips ACCU-CHEK Advantage Test Strips Cat. Nos. 2030365, 2030373, 2030381, 3000141 Cat. Nos. 336, 553, 787, 966
Healthcare Profe facility.

References

Control Solutions
ACCU-CHEK Comfort Curve Control Solutions ACCU-CHEK Advantage Control Solutions Cat. Nos. 2030390, 2030403, 2030411 Cat. Nos. 552, 986, 989
1. Stedman, Thomas Lathro 2. American Diabetes Assoc Supplement 1, p. S21S2

Lancets

ACCU-CHEK Softclix Lancet Device ACCU-CHEK Softclix Lancets ACCU-CHEK Softclix Lancets Cat. No. 957 Cat. No. 971 (100/box) Cat. No. 988 (200/box)