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.

Smart Pix

DEVICE READER

Users Manual

Accu-Chek Smart Pix Users Manual Date of issue: April 2009 2009, Roche Diagnostics GmbH All rights reserved ACCU-CHEK, ACCU-CHEK AVIVA, ACCU-CHEK AVIVA COMBO, ACCU-CHEK AVIVA NANO, ACCU-CHEK AVIVA EXPERT, ACCU-CHEK GO, ACCU-CHEK INTEGRA, ACCU-CHEK MOBILE, ACCU-CHEK PERFORMA, ACCU-CHEK SPIRIT, ACCU-CHEK SPIRIT COMBO, ACCU-CHEK SMART PIX, ADVANTAGE, CAMIT, COMBO, DISETRONIC, D-TRONPLUS, PERFORMA COMBO, PERFORMA EXPERT, PERFORMA NANO, VOICEMATE and LIVE LIFE. THE WAY YOU WANT. are trademarks of Roche. Other brand or product names are trademarks of their respective holders.
Product safety information This device is designed according to the International Standard IEC 60950 Safety of Information Technology Equipment and it was in perfectly safe condition when it left the factory. This product meets the requirements of EU Council Directive 2004/108/EC of December 15, 2004 on the approximation of the laws of the Member States relating to electromagnetic compatibility. Conformity with the aforementioned directive is certified by the CE mark on the device. The device may only be operated via the USB port of a suitable computer. The Accu-Chek Smart Pix system is installed, used and maintained by the user and is the user's sole responsibility.

Accu-Chek Smart Pix

Contents

Version note......I-4

Accu-Chek Smart Pix System overview.....1-1
1.1 1.2 1.3 1.4 Printed symbols......1-3 Overview of the Accu-Chek Smart Pix system....1-4 Overview of the Accu-Chek Smart Pix status indicator signals...1-5 Overview of the Accu-Chek Smart Pix user interface...1-6
Installing the Accu-Chek Smart Pix system...2-1
2.1 2.2 2.3 2.4 What you require for using the Accu-Chek Smart Pix system...2-1 Connecting the Accu-Chek Smart Pix device....2-2 Note about security settings in the Internet browser....2-3 Final preparations.....2-4 Configuring the Accu-Chek Smart Pix system....2-5 Selecting a language......2-7 Display options.....2-8 Personal Setup......2-9 Report Setup...... 2-11 Completing configuration..... 2-14
Preparing the devices.....3-1
3.1 3.2 3.3 3.4 3.5 3.6 3.7 3.8 3.9 3.10 3.11 3.12 3.13 3.14 3.15 3.16 3.17 Accu-Chek Active......3-4 Accu-Chek Aviva/Aviva Nano.....3-5 Accu-Chek Aviva Combo/Aviva Expert....3-6 Accu-Chek Compact/Integra.....3-7 Accu-Chek Compact Plus......3-8 Accu-Chek Go......3-9 Accu-Chek Mobile..... 3-10 Accu-Chek Sensor/Advantage..... 3-11 Accu-Chek Comfort..... 3-12 Accu-Chek Performa/Performa Nano..... 3-13 Accu-Chek Performa Combo/Performa Expert.... 3-14 Accu-Chek Pocket Compass software.... 3-15 Accu-Chek Voicemate Plus..... 3-16 Insulin pump Accu-Chek D-TRONplus (and Disetronic D-TRONplus).. 3-17 Accu-Chek Spirit insulin pump..... 3-18 Accu-Chek Spirit Combo insulin pump.... 3-19 Note on time settings for the Accu-Chek insulin pumps.... 3-20
Accu-Chek Smart Pix user's manual
Accu-Chek Report...... 4-1
4.1 4.2 Printing reports...... 4-2 Blood glucose: general information about the reports.... 4-3 Types of report..... 4-3 Evaluated data...... 4-4 Report Styles..... 4-5 Graphic elements of the reports..... 4-6 Blood glucose: content of the report.... 4-10 Trend Graph...... 4-10 Day Graph...... 4-12 Week Graph...... 4-14 Metabolic Control..... 4-16 Distribution..... 4-18 Logbook...... 4-19 Overview..... 4-21 Record List..... 4-23 Insulin pump: general information about the reports.... 4-24 Types of report..... 4-24 Graphic elements of the reports.... 4-25 Insulin pump: content of the report..... 4-27 Trend Graph...... 4-27 Day Graph...... 4-28 Week Graph...... 4-28 Basal Rates..... 4-29 Basal Bolus..... 4-30 Long Term Overview..... 4-31 Lists...... 4-32 Blood glucose and insulin pump: combined report... 4-33 Types of report..... 4-34 Graphic elements of the reports.... 4-34 Trend Graph...... 4-35 Day Graph...... 4-35 Week Graph...... 4-36 Overview..... 4-36 Record List..... 4-40 Analysing data in external applications.... 4-41 Literary references for reports..... 4-43 Low/High BG Index...... 4-43

4.7 4.8

Error signals and troubleshooting.....5-1
5.1 5.2 Errors without error signals.....5-1 Error signals on the device.....5-2

Maintenance......6-1

6.1 6.2 Cleaning the Accu-Chek Smart Pix system....6-1 Disposal......6-1

Appendix......7-1

7.1 7.2 7.3 7.4 Abbreviations......7-1 Technical data......7-1 Information about advice and the repair service....7-2 Roche Diagnostics addresses.....7-3

Version note

Version note This users manual applies to software version 3.0 of the Accu-Chek Smart Pix system. You can check the software version of your Accu-Chek Smart Pix system on the user interface (browser window) at any time. The version number is shown in the left corner of the menu bar. For the latest software version of the Accu-Chek Smart Pix system (as an installable update), contact your local Roche Diagnostics office.
Chapter 1, Accu-Chek Smart Pix System overview
Accu-Chek Smart Pix System overview
The Accu-Chek Smart Pix system is used to easily and automatically analyse blood glucose levels and therapy data from various Accu-Chek meters and insulin pumps. The analyses are displayed on a computer in the form of various, specifiable reports using a standard Internet browser. As a result the reports can also be printed on a connected printer. In many clinics and doctors' practices, such reports are used successfully (often together with the software products Accu-Chek Camit Pro or Accu-Chek Compass) to facilitate and speed up assessment of the metabolic situation. The Accu-Chek Smart Pix system features similar functionality. However, operator control is reduced to a simple activity which has since become everyday routine: just a few mouse clicks on a computer are sufficient to see the finished report on the monitor or get a hardcopy of it.
The procedure is as simple as it could possibly be: Prepare the meter for data transfer Place the meter in front of the Accu-Chek Smart Pix device The report is created automatically and can be viewed and printed on a computer using an Internet browser
On the following pages, you will find more detailed information about the various components, their application and the content of the reports compiled with the Accu-Chek Smart Pix system. Please read all these pages carefully. To be able to use your new system successfully, you should know everything that is explained here. If you have any additional questions, you will find some helpful information in the appendix, along with addresses of offices to contact in order to get the answers you require.
Printed symbols Some passages in this manual are highlighted by symbols. Please read these passages very carefully! There are more symbols on the type plate of the device and/or the packaging.

Symbol

Name Warning
Description On the type plate: Refer to accompanying documents. Please refer to safety-related notes in the manual accompanying this instrument. In the users manual: Indicates important health or safety information. This symbol draws attention to important information. Manufacturer

Warning

REF SN
Catalogue number Serial number This product fulfils the requirements of EC Directive 2004/108/EC. This product fulfils the legal requirements of the Peoples Republic of China on the use of certain substances in electronic products. US patent pending (US 2007/0055799)
Overview of the Accu-Chek Smart Pix system The system consists of the following components, which are described in brief below.
Accu-Chek Smart Pix Device: The central component of the system. This device is the interface to various Accu-Chek meters and insulin pumps, and it contains the electronics as well as the programs to process the data and results which are read in. The analyses created are temporarily stored in the device and can be viewed with an Internet browser. USB connector for hooking up to the computer. Status indicator, showing operating status. (see page 1-5). Infrared window for communication with Accu-Chek meters and insulin pumps. On the back of the device, there is a holder for an Accu-Chek IR Key. This accessory can be safely stored here to save space when it is not required. The Accu-Chek IR Key allows infrared data transfer with Accu-Chek meters which do not have a built-in infrared port (Accu-Chek Sensor and Accu-Chek Comfort). In the devices indicated, it is used for data transfer in place of the code chip. The Accu-Chek IR Key is available as an accessory (REF 0 3307778190) if you have not already received it from your dealer or Roche Diagnostics.
Not illustrated: 6 Users manual (this document)
Overview of the Accu-Chek Smart Pix status indicator signals The Accu-Chek Smart Pix system indicates various operating states on the status indicator on top of the device. The following signals can appear on this indicator: 7 Off: The Accu-Chek Smart Pix device is not connected to a computer, or the computer is not switched on. 9
Centre of status indicator Lit continuously: report is ready on the computer, idle state. Flashing slowly: error Top/bottom dots Flashing simultaneously about once a second: device is ready for operation and is actively searching for meters or insulin pumps. Flashing fast simultaneously: data transfer Left/right dots Flashing slowly simultaneously: processing report data Software updates for the Accu-Chek Smart Pix system can be installed via the computer. While such an update is being installed, the centre of the status indicator 8 and (simultaneaously) the dots 9 and 10 flash alternately.
Overview of the Accu-Chek Smart Pix user interface The Accu-Chek Smart Pix system has a user interface which is displayed in standard Internet browsers. You do not require an Internet connection if you wish to use the Accu-Chek Smart Pix system. The relevant pages are stored in the device itself where they can be called up. The user interface is optimised for a screen resolution of at least 1024 x 768 pixels. 13

If you can follow the above procedure on your computer, the Accu-Chek Smart Pix system is ready to read data from a meter or an insulin pump. However, you should first perform the configuration described below in order to customise the reports properly. If you have not been able to complete this brief check successfully (e.g. if the removable disk is not shown), see Chapter 5 for information about possible sources of error.
Configuring the Accu-Chek Smart Pix system The Accu-Chek Smart Pix system enables you to customise the appearance and default parameters (e.g. language, default setting English) of the reports to suit your requirements. To perform this configuration (before using the system for the first time) open the user interface of the Accu-Chek Smart Pix system, which is stored in the START.HTM file on the removable disk. Open the START.HTM file with a double click. The default Internet browser on your computer is launched and, at the same time, the Accu-Chek Smart Pix user interface is loaded. Click (once, as is usual in browsers) on the Settings button. The Accu-Chek Smart Pix device now quits search mode (the centre of the status indicator is lit continuously).
You will now see the page showing a Summary of the current settings (on the right) and the navigation bar with the links to the various setup areas (on the left). The following setup options are available Language Display Options for setting up display formats and year Personal Setup for name and time blocks Report Setup
The following pages provide detailed descriptions of the various setup areas. First of all you should set the language you prefer so that the user interface for all other settings is displayed in that language.
Note about saving the settings: The response to saving the following setting may vary according to the operating system and browser you are using: Changed settings (e.g. Personal Setup) may not immediately be displayed. In this case, reload the page (using the appropriate browser button). Additional browser windows may open during the setup process. Simply close them when you have completed all your settings.
Selecting a language On the navigation bar, click on the Language link. The display pane now shows a drop-down list with all available languages, the default setting being English. Select the language which you want to be used both on the browser screen and for printouts. Click on the arrow pointing down to open the selection list. Click on the desired language to select it. If you have changed the selection, click the Save button to send the new selection to the Accu-Chek Smart Pix system. In the next dialog box, confirm the change to the new language.

If you leave this page (e.g. by clicking on another link or closing the browser) without saving your selection, any change you have made will have no effect.
Display options On the navigation bar, click on the Display options link. The display pane now shows the options for the various formats. Select the following settings here: Date and time format. Weekend days, usually non-working days. These are highlighted in some analyses. Current year (only for the analysis of data from meters which do not allow you to set the year).
The selection procedure is identical for all options: Click on the arrow pointing down to open the selection list. Click the desired setting to select it. When you have completed all your settings on this page, click the Save button to send the new selection made to the Accu-Chek Smart Pix system.
Personal Setup On the navigation bar, click on the Personal Setup link. The display pane now shows the available options. Input fields for personalising the printouts (here you can enter, for example, the name of a doctor's practice or pharmacy). This is where you can enter whatever text you want. The length of each text is limited. Therefore use abbreviations or another line for your entries. Setting the time ranges. By setting time ranges, you divide a 24-hour day into eight periods which are determined by important regular events (e.g. main meals). For each period, you can specify the start time while the end time is automatically given with the start time set for the next period.
The time ranges set here are used in reports to structure them visually and chronologically in case there is no relevant information from the meter or insulin pump. The time ranges can be set in 30-minute increments. Click on the arrow pointing up (next to the display on the right of a start time) in order to set it to a later time. Click on the arrow pointing down (next to the display on the right of a start time) in order to set it to an earlier time. When you have completed all your settings on this page, click on the Save button.
These settings, unlike any other settings, must be saved immediately in a text file on the removable disk (Accu-Chek Smart Pix), as described below. If you leave this page (e.g. by clicking on another link or closing the browser) without saving your selection, any change you have made will have no effect.
As soon as you click on the Save button in the Personal Setup window, another window opens in the browser showing text which contains your settings for this area. Now proceed as follows: Click the Save link beneath the text or select the Save as command from the File menu
In the next dialog box, select the storage location, the name and other file attributes: Select removable disk (Accu-Chek Smart Pix) as storage location. The following settings are defaults and must not be changed (if displayed): Name Settings File type Text file (*.txt) Code Unicode (UTF-8) If all entries are correct, click on the Save button and close the text window via the close box (top right of the window).

3.11 Accu-Chek Performa Combo/Performa Expert The Accu-Chek Performa Combo/Performa Expert meter has a built-in infrared port for data transfer. In order to read data from these devices, proceed as follows: Place the device no more than 10 cm away from the infrared window on the Accu-Chek Smart Pix device. Both infrared windows must be facing one another.
If you use the Accu-Chek Performa Combo meter together with an Accu-Chek Spirit Combo insulin pump, you should always read data from both devices at the same time in order to get information that is as complete as possible (especially concerning bolus quantities and basal rates).
3.12 Accu-Chek Pocket Compass software
Accu-Chek 10:05 am 3/20/05
Data Transfer Diary Reports Health Management Options

Data Transfer 3/20/05

The Accu-Chek Pocket Compass software uses the infrared port of a handheld computer for data transfer. In order to read data from the handheld computer, proceed as follows: Place the handheld computer no more than 10 cm away from the infrared window on the Accu-Chek Smart Pix device. Both infrared windows must be facing one another. Turn the handheld on and start the Accu-Chek Pocket Compass software. On the main menu screen, touch Data Transfer. Then touch Export Data. Data transfer starts automatically.
Import Data Export Data Sync. Devices Information Menu
Export Data Transferring data.

Cancel

3.13 Accu-Chek Voicemate Plus The Accu-Chek Voicemate Plus voice unit has a built-in infrared port for data transfer. In order to read data from these devices, proceed as follows: Place the device no more than 10 cm away from the infrared window on the Accu-Chek Smart Pix device. Both infrared windows must be facing one another. On the Accu-Chek Voicemate Plus voice unit, the infrared port is located on the right side of the device near the numeric keypad. Switch on the voice unit, press the 0 key once and the 3 key twice (Data transfer menu, Transfer data to PC via IR). Data transfer starts automatically.
3.14 Insulin pump Accu-Chek D-TRONplus (and Disetronic D-TRONplus) The Accu-Chek D-TRONplus (Disetronic D-TRONplus) insulin pump has a built-in infrared port for data transfer. In order to read data from these devices, proceed as follows: Place the device no more than 10 cm away from the infrared window on the Accu-Chek Smart Pix device. Both infrared windows must be facing one another.
Make sure that your Accu-Chek (Disetronic) DTRONplus insulin pump is in STOP mode and that the key lock (KeyLock) is deactivated or unlocked. Press the button 4 times to select the Data Transfer function.
Confirm the selection with the button. The built-in infrared port is now activated, and data transfer starts automatically.

In this case, the Accu-Chek Smart Pix system may not be able to analyse the stored insulin pump data. Therefore, only change the time set in your insulin pump if it is in STOP mode. If you want to reset the time programmed in your Accu-Chek insulin pump (e.g. at the end of the summer time or due to time zone changes when travelling to Western directions) and to analyse the existing data using the Accu-Chek Smart Pix system:
Before changing the time, read the existing data from your Accu-Chek insulin pump. The next time data is read, the Accu-Chek Smart Pix system only analyses the insulin pump data which was stored after the time was reset.
If you use your insulin pump together with a blood glucose meter and want to analyse the data of both devices using the Accu-Chek Smart Pix system, always change the time for all devices at once. This ensures that the information represented in the reports is assigned correctly. Combined reports are only created for devices having the same date and time settings.
Chapter 4, Accu-Chek Report

Accu-Chek Report

If you have initiated the transfer of data from a meter, an insulin pump or the Accu-Chek Pocket Compass software, as described in the previous chapter, the following now occurs: The top/bottom dots on the status indicator flash quickly during the data transfer. Make sure not to move the devices during this process, so as not to interfere with the data transfer. When the data has been transferred, the Accu-Chek Smart Pix system prepares the reports. The two left/ right dots on the status indicator flash (more slowly) during this process. When the reports have been completed, the centre of the status indicator is lit continuously. This means the reports are now available on the computer and the device search has been switched off (standby mode).
The data stored in the meter or insulin pump is not deleted after data transfer. The Accu-Chek Smart Pix system creates reports (Accu-Chek Report) with various graphic and statistical analyses. All the elements of a report are always available on the screen. Your decision on which report elements to print out can be made on a case-by-case basis.
Printing reports All the reports displayed on the screen can also be printed out. Do not use the integrated print function of the browser to print one or more reports after data transfer, instead use the special print functions offered by the Accu-Chek Smart Pix system. In any view of the report, click on the Create Report button on the menu bar. Select the reports you want to prepare for printing. Now click on the Create Report button at the bottom of the screen. In the preview that is now displayed, click on the Print button. In the next dialog box, you can select the printer and configure it if necessary. Click on the Print button when you want to start printing the report on the printer you have selected. Close the window showing the print preview.

If you only wish to print the currently displayed analysis, use the Print Page button below the relevant report.
Blood glucose: general information about the reports Types of report The Accu-Chek Smart Pix system creates single-page or multi-page reports for defined periods (e.g. the last 2 or 4 weeks). The period of time and the style of the report have been set during configuration. A (blood glucose) report can generally contain any of the following elements: [1] [2] [3] [4] [5] [6] [7] [8] Trend Graph Day Graph Week Graph Metabolic Control Distribution Logbook Overview Record List
The illustration on the left shows examples of the printed version of the report.
Evaluated data During creation of the individual analyses, the data read is checked by the Accu-Chek Smart Pix system. The following data is not included in the statistical analysis: Test results outside the period selected Test results saved without date and time Tests with control solution Invalid/deleted tests Tests outside the measuring range (marked Hi/Lo)
You will find some of this information summarized in the overview (e.g. number of Hi/Lo results) or in the logbook and the record list (e.g. results without a date or time, tests with control solution). Existing target range definitions are only adopted from the Accu-Chek Pocket Compass software. Apart from that, the settings made during configuration of the Accu-Chek Smart Pix system apply. Please note the following when using the Accu-Chek Smart Pix system with several meters: To ensure that the report belonging to a particular meter is displayed, compare the serial number on the meter with the serial number displayed in the report.
Report Styles For some analyses a style is defined, either Detailed , during configuration of the Accu-Chek or Trends Smart Pix system. These two styles offer different types of presentation for identical information. You can choose from these styles for each of the following analyses individually: Trend Graph Day Graph Week Graph
Detailed These analyses are represented in linear form. Each test result is plotted along the time axis according to the time when the test was performed. Test results performed within a 10 hour period are connected by a line. This creates (angular) curves which, together with the actual test result entry, make it possible to obtain a detailed analysis of individual results and trends. Insulin and carbohydrate amounts (displayed in the upper and lower edge of the report, if transferred by the device) can only be displayed in this report style. Trends These analyses are time block-related, i.e. all the test results within a certain period are assigned to a single time block. The figures displayed are the mean value, the variance, the minimum and the maximum of those test results. A selective analysis of individual results is not possible, but it is easier to make statements about general trends within certain periods of time (time blocks/days/ weekdays).

Trends: Here you will find the mean level for each individual day from the selected time range, in the form of a single block (black box containing a horizontal line) for the respective date. The standard deviation, minimum levels and maximum levels, etc. are plotted according to the symbols on page 4-8. When you position the mouse cursor over a value bar, a tooltip (help text) will appear at this place after a short period of time which displays the related figures. These figures are: n: Number of analysed test results. MBG: Mean value of all analysed results. SD: Standard deviation or variance of the analysed results.
Day Graph This analysis is used to make it easier to recognise patterns repeated daily. For this purpose, all the data is placed on a 24-hour grid. As a result all the tests performed at (approximately) the same time of day are shown at the same position on the time axis. If these time blocks are defined in the meter, the information will be evaluated when the time axis is set out. If they are not, the time block settings in the Accu-Chek Smart Pix configuration will be used. The analysis can be displayed in two different styles of presentation. The one which appears on your report is defined during configuration. Detailed: All the blood glucose levels are plotted at the relevant time of day according to the time when the test was performed. Levels that have been determined within a period of 10 hours are connected by a black line in chronological order. A (thicker) blue curve represents the development of the mean level (in intervals of one hour if a test result falls in each interval). Time block boundaries are represented by vertical grey lines. This is also where you will find a display of insulin doses (if stored in the meter). Each insulin dose is plotted on the chart from the top downwards and you can read the relevant levels off the upper area of the right-hand y-axis. At the lower edge of the analysis, carbohydrate amounts are shown (if stored in the meter). In the lower area of the righthand y-axis, you will find the scale for the carbohydrate amounts.
Trends: All the blood glucose levels are assigned to one of eight time blocks according to the time when the test was performed. In this way eight areas are created within which you are shown the average (black box containing a horizontal line), the standard deviation (blue bar), the minimum level and the maximum level. The start and end of the time blocks are plotted on the x-axis. When you position the mouse cursor over a value bar, a tooltip (help text) will appear at this place after a short period of time which displays the related figures. These figures are: n: Number of analysed test results. MBG: Mean value of all analysed results. SD: Standard deviation or variance of the analysed results.

If there are levels without any indication of date or time, they are also displayed on a separate list (sorted according to their order in the device memory). The level measured last is in the top left position. In such a case, the statistical analyses can only be displayed for all the levels because it is not possible to assign them to time blocks.
Overview The report element Overview contains general and statistical information about the levels processed for the time range selected. Here you will find the following information (in the order shown here): Report title Report period: Period (according to configuration) with the most recent date. Meter(s) (symbol): Displays the meter used and its serial number. If you are using several meters (see page 2-13), the symbol is displayed with all read serial numbers.
Report Report period: Period (according to configuration) with the most recent date. Evaluated results Number of evaluated blood glucose results in the period selected. Maximum/Mean BG/Minimum: Highest and lowest blood glucose level which was measured in the period selected, and the average of all the levels measured. SD: Standard deviation or variance of the analysed results. BG Test Frequency: Average number of blood glucose tests per day for each day of the period selected. In addition, the statistical information also contains the value (in brackets) for those days only on which a test was performed at least once. Target Range: The target range used for evaluation.
Hypo limit: Blood glucose levels below this threshold are marked as hypoglycemia. High/low BG index: These figures represent the frequency and the resulting risk of blood glucose levels being too low or too high (see literary references on page 4-43). Figures should be as low as possible. Hi/Lo: Number of test results above (Hi) and below (Lo) the measuring range. Controls: Number of tests with control solution.
Device: Serial number: Serial number of the meter. Date/Time: Time setting of the meter when the report is created.
If you are using several meters, this information is repeated for each meter. Stored Results: Total number of test results in the device(s), with timeframe details (from. to).
Additional information This information is only displayed if required: Values without Date/Time: Number of test results which were stored without date or time information. Values with warnings: Number of test results which were stored with temperature warning, expiry note, etc.
Record List The record list shows the test results sorted by date and time of the test. You can specify whether this list is sorted in ascending or descending order under settings, (see page 2-12). All the blood glucose results are shown in chronological order together with additional information (events, insulin, etc.) The example opposite has been shortened. At the bottom you will find statistical analyses of all the test results plotted. The number of tests, the blood glucose average and the standard deviation are determined. In addition the minimum and maximum results, the high/low BG index and the number of test results above (Hi) and below (Lo) the measuring range are displayed. If the meter transfers the blood glucose result information before meal or after meal , an advanced statistical analysis will appear. Mean values and standard deviations are calculated separately for test results before and after meals. The average change of the blood glucose test result for paired values is also calculated. Such a paired value is the result of a test being performed before the meal and a second test being performed after the meal and following the first test within a period of one to two hours. If the evaluated period contains blood glucose levels which are marked with the event User-defined, a separate statistic is calculated and displayed for these. In addition, levels without date and time information as well as levels which were determined using control solution are each listed in separate statistics.

Insulin pump: general information about the reports Types of report The Accu-Chek Smart Pix system creates single-page or multi-page reports for defined periods (e.g. the last 1 or 2 weeks). The period has been defined in configuration. An (insulin pump) report can contain any of the following elements: [1] [2] [3] [4] [5] [6] [7] Trend Graph Day Graph Week Graph Basal Rates Basal Bolus Long Term Overview Lists (Bolus, Basal, Events)
Graphic elements of the reports On all reports, you will find legends explaining the meaning of individual elements. Here are detailed explanations of the various elements. Symbols On the insulin pump reports, you will find the following symbols: Basal rates (represented in the Trend Graph) Mean total basal amount per day (Basal Bolus) Basal profile Changes to the basal rate (Basal Bolus) Changes to the basal rate (with designation, Trend Graph) Temporary increase in basal rate Temporary decrease in basal rate Active basal rate (Long Term Overview) Switch to a named basal profile (e.g. A) Switch from a named basal profile (e.g. A) to another named basal profile (e.g. B)
Total of basal insulin + bolus insulin per day Standard bolus, represented in charts from the top downwards Scroll bolus, represented in charts from the top downwards Extended bolus, represented in charts from the top downwards ; the width of the bar shows the duration of the delivery Multiwave bolus, represented in charts from the top downwards ; the width of the bar shows the duration of the extended portion Bolus Advice; always appears in combination with one of the four bolus type symbols described above. These boluses have been calculated with a bolus calculator (from a respective meter). Bolus advice is only displayed if the bolus has been delivered and is thus stored in the pump. Prime infusion set Return of piston rod (cartridge change) Insulin pump run Insulin pump stop
Insulin pump: content of the report Trend Graph This analysis shows the trend in insulin dosage over the time range selected. You will find the days and months along the horizontal (x) axis and the respective amounts of insulin delivered along the vertical (y) axis. The basal rate chart is at the bottom, and the individual boluses are shown at the top. Therefore, you will find the basal rate scale along the left-hand y-axis (from the bottom upwards) and the scale for the boluses along the right-hand y-axis (from the top downwards). In addition to the actual insulin dose, various events are also shown. These are:
Pump events (in this case: black symbols on the chart) Switch of basal profile (in this case: blue flag symbolises a switch to basal profile 1) Changes in basal rate (in this case: basal profile 3)
You will find the meanings of the various symbols in brief in the legend and in detail on page 4-25. As in the blood glucose analysis, the days that are usually non-working days (weekends) are marked with an additional green bar on the horizontal axis.

Long Term Overview The Long Term Overview report element contains general and statistical information about the figures imported. The time range of this analysis may be different from that of other analyses because longer periods (up to 12 weeks) are analysed. Here you will find the following information (in the order shown here): Report title Report period: Period (according to configuration) with the most recent date. Insulin pump (symbol): Displays the insulin pump used and its serial number.
Device: Serial number: Serial number of the insulin pump. Date/Time: Date and time on the insulin pump at the time of data transfer. Remaining Use Time: Remaining time of use for this insulin pump. BR Profile Selections: The frequency (per week) with which the insulin pump was switched over to a different basal profile. Time and Date Settings: The time and date information was re-entered this number of times (e.g. on account of summer time, transcontinental flights, etc.)
The table shows the percentage of certain basal profiles (and times when the insulin pump was in STOP). The currently active basal profile is marked with a tick. Additional information This information contains error messages and warnings (and their number) which were stored in the insulin pump.
Lists The three groups of information, Bolus, Basal and Events are also output in the form of lists. You can specify whether this list is sorted in ascending or descending order under settings, (see page 2-12). On these lists, you will find detailed documentation of each individual event stored in the insulin pump, including date and time. Boluses which have been delivered using bolus advice are flagged with the corresponding symbol. To see all the lists, please use the scroll bar on the right-hand side. The examples opposite have been shortened.
Blood glucose and insulin pump: combined report If you analyse data from a blood glucose meter together with data from an insulin pump, combined analyses of the simultaneously obtained information can provide useful indications for therapy. In addition to the individual blood glucose and insulin pump analyses a combined report is therefore available.

Record List The combined record list shows the test results and insulin pump information, sorted by date and time. You can specify whether this list is sorted in ascending or descending order under settings, (see page 2-12). All the blood glucose results are shown in chronological order together with any recorded carbohydrate and insulin pump information. The example opposite has been shortened. Blood glucose and insulin pump information that is chronologically close is highlighted with a yellow background. This makes it easier to identify insulin doses that were delivered in direct relation to blood glucose tests. Boluses which have been delivered using bolus advice are flagged with the corresponding symbol.
Analysing data in external applications You can also open and evaluate data read from meters and insulin pumps in other applications. Whenever data is transferred, XML files are also created in addition to the graphical and tabular analyses (for blood glucose meters and insulin pumps separately, including related XSL style sheets for formatting purposes). These files can be read by other suitable applications. The following example shows how to import an XML file into Microsoft Excel (as from version 2002). Start Microsoft Excel and choose the command File > Open. In the file selection dialogue, navigate to the SmartPix drive and from there go to the REPORT / XML folder to display the contents saved there. If no file is displayed there, you must first select the file type XML in the file selection dialogue, if not already done.
If you have read in data from a meter as well as an insulin pump, you will find two XML files. The first letter of the file name indicates what data is contained: Gxxxxxxx.XML: glucose results from meter Ixxxxxxx.XML: data from insulin pump Select the desired file and click Open.
In the following dialogue box, select to import the XML data using the related style sheet. This additional file prepares and formats the data records in a legible way.
Be careful to select the correct style sheet for the chosen XML file: ACSPIXMT.XSL is the style sheet for meter data (MT = meter). ACSPIXIP.XSL is the style sheet for insulin pump data (IP = insulin pump).