Accu-Chek Performa Owner's Booklet
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Accu-Chek Performa Owner's Booklet

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BLOOD GLUCOSE METER
Owner's Booklet

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  • Page 1 CCU- ® Performa BLOOD GLUCOSE METER Owner’s Booklet...
  • Page 3 Whether the Accu-Chek Performa Meter is your first blood glucose meter or you have used a meter for some time; please take the time to read this booklet carefully before you use your new meter. To use it correctly and dependably, you need to understand its operation, screen displays, and all individual features.
  • Page 4 Your new Accu-Chek Performa Meter is for quantitative blood glucose testing using Accu-Chek Performa test strips. Suitable for self-testing. The Accu-Chek Performa meter may be used by patients who test their own blood glucose as well as by healthcare professionals for monitoring patients’ blood glucose values. The system includes: •...
  • Page 5 The meter is for outside the body ( in vitro ) use. It should not be used to diagnose diabetes. • This meter requires Accu-Chek Performa Test Strips. Other test strips will give inaccurate results.

  • Page 7: Table Of Contents

    Contents Chapter 1: Understanding Your New System ............7 The Accu-Chek Performa Meter ..............7 Coding Your Meter ..................9 Adjusting the Time and Date—First Time Use..........11 Using the Accu-Chek Performa System............13 Chapter 2: Testing Your Blood Glucose .............14 Performing a Blood Glucose Test..............14 Flagging Test Results ..................18...
  • Page 8 Chapter 4: Control Testing .................44 Why Perform Control Tests................44 About the Control Solutions................45 Performing a Control Test................46 Understanding Control Test Results...............50 Chapter 5: Maintenance and Troubleshooting..........53 Changing the Battery ..................53 Cleaning Your Meter..................55 Maintenance and Troubleshooting..............56 Screen Messages and Troubleshooting ............57 Chapter 6: Technical Information ..............64 Product Limitations ..................64...

  • Page 9: Chapter 1: Understanding Your New System

    Chapter 1: Understanding Your New System The Accu-Chek Performa Meter Infrared (IR) Window – Display – Used to transfer data Shows results, from the meter to a messages, and computer or PDA. results stored in memory. On/Off/Set Button – Turns the meter on or Right and Left off and sets options.
  • Page 10 Golden End – Insert this end of the test strip into the meter. Yellow Window – Touch blood drop or control solution here. Test Strip Test Strip Container Control Solution Bottle Code Chip Battery – Insert with On/Off/Set Infrared (IR) Top View (for example) (+) symbol facing up.

  • Page 11: Coding Your Meter

    Coding Your Meter 1. Make sure the meter 2. Turn the meter over. 3. Remove the old code chip is turned off. (if there is one in the meter) and discard it. ▲ Change the code chip every time you open a new box of test strips!
  • Page 12 4. Turn the code chip over so the code 5. Leave the code chip in the meter number faces away from you. Push until you open a new box of test it into the meter until it stops. strips. Notes: •...

  • Page 13: Adjusting The Time And Date-First Time Use

    Adjusting the Time and Date—First Time Use Having the correct time and date in your meter is important if you use the meter memory or if you want to download your results to a computer. decrease increase 1. Press and release 3.
  • Page 14 decrease increase 4. Press and release 5. Repeat to set am/pm, day, symbol appears. The time month, and year. and date are now set. to adjust the minutes. Press to set the 7. See Chapter 3 “Meter 6. Once you set the year, minutes.

  • Page 15: Using The Accu-Chek Performa System

    Using the Accu-Chek Performa System • Only use Accu-Chek Performa Test Strips. • Be sure to check the expiry date on the test strip container. Do not use the test • Replace the code chip every time you strips after that date.

  • Page 16: Chapter 2: Testing Your Blood Glucose

    Chapter 2: Testing Your Blood Glucose Performing a Blood Glucose Test Before you perform your first blood test, set up your meter correctly. You need the meter, a test strip, and a lancet device with a lancet loaded. CODE 1. Wash and dry your hands. 4.
  • Page 17 Yellow Release Button 5. A test strip and 6. Perform a fingerprick with your lancet device. Blood samples flashing blood drop taken from the palm are equivalent to blood taken from the symbol appear on fingertip. For detailed information on how to obtain blood the display.
  • Page 18 7. Gently squeeze your finger to assist the put blood on top of the test strip. When flow of blood. This helps you get a blood you see flash, you have enough blood drop. in the test strip. If you applied blood but do not see the flashing , you may 8.
  • Page 19 9. Your result appears on the display. If you want to flag your test result for a special event, leave the test strip in the meter (see the next section). Otherwise, discard the used test strip. Note: After a successful test, the meter turns itself off five seconds after the test strip is removed.

  • Page 20: Flagging Test Results

    Flagging Test Results If you wish, you can “flag” your test result with an asterisk ( ) to indicate a special result. You might want to flag an event such as an AST result or exercise. When you review your results in memory, this “flag”...

  • Page 21: Alternative Site Testing (Ast)

    Alternative Site Testing (AST) You have the option of testing other places on your body besides the fingertip. Blood obtained from a fingertip or palm – fleshy part of the hand under the thumb (thenar) and the little finger (hypothenar) – can be used at any time to measure blood glucose. If blood from an alternative site – forearm, upper arm, thigh, or calf - is used, there are certain times when testing is not appropriate (see below).
  • Page 22 You need the meter, a test strip, a lancet device designed for AST, and a lancet. CODE 1. Prepare your lancet device. 3. Make sure the code number on the display matches the code number on 2. Insert a test strip into the meter in the the test strip container.
  • Page 23 4. A test strip and flashing 5. Press the lancet device 6. Trigger the lancet device blood drop symbol firmly against a fleshy while keeping steady appear on the display. area on the alternative pressure on the area. site. Press the lancet Apply pressure to the device up and down in a area with the lancet...
  • Page 24 7. Touch the drop to the front edge of the do not see the flashing , you may yellow window of the test strip. When reapply more blood within five seconds. you see flash, you have enough blood Discard the used test strip. in the test strip.

  • Page 25: Normal Blood Glucose Values

    Normal Blood Glucose Values These test strips are calibrated to deliver plasma-like results. The normal fasting blood glucose range for an adult without diabetes as related to plasma is 4.1–5.9 mmol/L. For people with diabetes: Please consult your diabetes team for the blood glucose range appropriate for you.

  • Page 26: Unusual Test Results

    Read Chapter 2 “Testing Your Blood Glucose” and test again. If you still have problems, call the Accu-Chek Enquiry Line on 1800 251 816. 6. Check that the code number on the meter If they do not match, insert the correct code chip display matches the code number on the test in the meter and test again.

  • Page 27: Symptoms Of High Or Low Blood Glucose

    Symptoms of High or Low Blood Glucose Being aware of the symptoms of high or low blood glucose can help you understand your test results and decide what to do if they seem unusual. Here are the most common symptoms: High blood glucose (hyperglycemia): fatigue, increased appetite or thirst, frequent urination, blurred vision, headache, or general aching.

  • Page 28: Chapter 3: Meter Memory, Setup, And Downloading

    Chapter 3: Meter Memory, Setup, and Downloading Memory Storing Test Results Your meter automatically stores up to 500 test results with the time and date of the test. You can review them at any time. Test results are stored from the newest to the oldest. It is very important to have the correct time and date set in the meter.

  • Page 29: Viewing Test Results

    Viewing Test Results Press either to enter memory. Your most recent result appears. Press to view previous results in order. OR, press to look at your 7, 14, or 30 day averages, in that order.

  • Page 30: Meter Setup

    Meter Setup Using the Set-up Mode By using the set-up mode, you can personalize your meter to suit your lifestyle. Here are the features you can customize— Time and Date—set the time and date Beeper—select “On” or “OFF” Alarm clock—select 1–4 times a day for a reminder to test Hypo alarm—select “On”...

  • Page 31: Setting The Time And Date

    You are here TIME / DATE BEEPER ALARM CLOCK HYPO ALARM (hrs, min, am/pm, (on/off) (A-1, A-2, A-3, A-4) (off, on, level) day, month, year) Setting the Time and Date decrease increase 1. Press to turn the 2. Enter the set-up mode 3.
  • Page 32 decrease increase 4. Press and release to set the hour. 5. Press and release to adjust the minutes. Press to set the The minutes flash. minutes. Note: You can press and hold to scroll faster.
  • Page 33 6. Repeat to set am/pm, day, month, and 7. If you want to set up more options, year. press and release . If you want to exit, press and hold until the flashing test strip symbol appears.

  • Page 34: Setting The Beeper On/Off

    You are here TIME / DATE BEEPER ALARM CLOCK HYPO ALARM (hrs, min, am/pm, (on/off) (A-1, A-2, A-3, A-4) (off, on, level) day, month, year) Setting the Beeper On/Off Your new meter has the beeper preset to “On.” You can set the beeper to “OFF,” if you prefer—this will not affect your test results.
  • Page 35 1. Press to turn the 2. Enter the set-up mode 3. Press and release meter on. The flashing (press and hold repeatedly until you reach test strip symbol appears. about four seconds). the display with the “Set-up” flashes on the flashing beeper symbol display.
  • Page 36 5. If you want to set up more options, 4. Press to select “On” or press and release . If you want to “OFF.” exit, press and hold until the flashing test strip symbol appears.

  • Page 37: Setting The Alarm Clock Function

    You are here TIME / DATE BEEPER ALARM CLOCK HYPO ALARM (hrs, min, am/pm, (on/off) (A-1, A-2, A-3, A-4) (off, on, level) day, month, year) Setting the Alarm Clock Function The alarm clock function is a handy way to remind you to test. You can set 1 to 4 alarms per day.
  • Page 38 When you are setting the time for the alarm clock function, the bell symbol remains on the display and “set-up” flashes continuously. 1. Press to turn the 2. Enter the set-up mode 3. Press and release meter on. The flashing (press and hold repeatedly until you reach test strip symbol appears.
  • Page 39 4. Press and release 5. If you select “On,” the 6. Press and release to select hour flashes. “A-1” and to select the “On” or “OFF.” Press the bell symbol remain on hour. Press and release and release to set the display.
  • Page 40 7. The minutes flash. Press 8. Press and release 9. The next alarm “A-2” and and release set the minutes. “Am” or “set-up” flash on the select 00, 15, 30, or 45. “pm” flashes on the display with “OFF” and These are the only display.

  • Page 41: Setting The Hypoglycemic (Hypo) Alarm Function

    You are here TIME / DATE BEEPER ALARM CLOCK HYPO ALARM (hrs, min, am/pm, (on/off) (A-1, A-2, A-3, A-4) (off, on, level) day, month, year) Setting the Hypoglycemic (Hypo) Alarm Function You can set the meter to let you know when your blood glucose is possibly too low.
  • Page 42 2. Enter the set-up mode 3. Press and release 4. Press and release (press and hold repeatedly until you reach to switch about four seconds). the display with “OFF” between “On” and “OFF.” “Set-up” flashes on the and the flashing “set-up” Press and release display.
  • Page 43 5. If you select the hypo alarm “On,” “set-up” and flash. The display shows 3.9 mmol/L. 6. Press and release to select the level you want. Press and release set it. 7. Press and hold until you see the flashing test strip symbol to exit the set-up mode.

  • Page 44: Downloading Your Results To A Computer Or Pda

    Downloading Your Results to a Computer or PDA You can transfer your stored results to a Infrared (IR) computer to track, identify patterns, and print. Window Transferring Data 1. Turn off your meter. 2. Install the software according to the instructions. 3.
  • Page 45 • If the data did not transfer successfully, try again. If you still have problems, call the Accu-Chek Enquiry Line on 1800 251 816. • To make the most of the download feature, you must set the time and date correctly.

  • Page 46: Chapter 4: Control Testing

    Chapter 4: Control Testing Why Perform Control Tests Performing a control test lets you know that your meter and test strips are working properly to give reliable results. You should perform a control test when: • You open a new box of test strips •...

  • Page 47: About The Control Solutions

    About the Control Solutions • Only use Accu-Chek Performa Control Solutions. • Your meter automatically recognizes the control solution. • The control solution results are not displayed in memory. • Write the date you opened the bottle on the bottle label. The solution is good for three months from that date or until the expiry date on the bottle label, whichever comes first.

  • Page 48: Performing A Control Test

    Performing a Control Test You need the meter, a test strip, and control solution Level 1 and/or Level 2. The control level is printed on the bottle label. CODE 1. Insert a test strip into the meter in the 2. Make sure the code number on the direction of the arrows.
  • Page 49 3. Select the control solution 4. Put the meter on a flat 5. Remove the control bottle you want to test. You will surface, like a table. cap. Wipe the tip of the enter the level later in the bottle with a tissue. test.
  • Page 50 6. Squeeze the bottle until a tiny drop forms 7. A result appears on the display, along with at the tip. Touch the drop to the front a control bottle symbol and a flashing edge of the yellow window of the test “L.”...
  • Page 51 8. Press to set the level in the meter. container label. “Err” and the control result alternate on the display if the 9. “OK” and the control result alternate on result is not in range. Remove the test the display if the result is in range. The strip and discard it.

  • Page 52: Understanding Control Test Results

    Understanding Control Test Results Range (mmol/L) Level 1 1.7–3.4 Level 2 14.4–19.5 Example Example The label on your test strip container shows When the control result is inside the range the acceptable ranges for both the Level 1 on the test strip container, your test strips and the Level 2 control solutions.
  • Page 53 If your control result is not inside the acceptable range, here are some things you can do to solve the problem: Troubleshooting Checks Action 1. Check the expiry date of the test strips If either is past the expiry date, discard and control solution.
  • Page 54 9. If you are still unsure of the Repeat the control test with a new test problem… strip. If you still have problems, call the Accu-Chek Enquiry Line on 1800 251 816.

  • Page 55: Chapter 5: Maintenance And Troubleshooting

    Chapter 5: Maintenance and Troubleshooting Changing the Battery 1. Open the battery door on the back of the 2. Insert the new battery with the + side up. meter by pushing the tab in the direction 3. Put the battery door back in place and of the arrow and pulling the door up.
  • Page 56 Notes: • The meter uses one 3-volt lithium battery, type CR 2032. It is a good idea to have a spare battery available. • Be sure the battery goes in + side up or facing you. • After you change the battery, your meter prompts you to confirm the meter’s time and date settings.

  • Page 57: Cleaning Your Meter

    Cleaning Your Meter Caring for your Accu-Chek Performa Meter is easy - just keep it free of dust. If you need to clean it, follow these guidelines carefully to help you get the best performance possible: Do Not • Make sure the meter is turned off •...

  • Page 58: Maintenance And Troubleshooting

    Your meter needs little or no maintenance with normal use. It automatically tests its own systems every time you turn it on and lets you know if something is wrong. If you drop the meter or think it is not giving accurate results, call the Accu-Chek Enquiry Line on 1800 251 816.

  • Page 59: Screen Messages And Troubleshooting

    ▲ Never make treatment decisions based on an error message. If you have any concerns, please call the Accu-Chek Enquiry Line on 1800 251 816. The meter will not turn on or the display is blank. • Battery is dead—Insert new battery •...
  • Page 60 The meter is ready for you to insert a test strip. Battery power is low. Change the battery soon. The meter is ready for a The meter is in set-up drop of blood or control mode, waiting for you to solution.
  • Page 61 Blood glucose may be This test result was higher than the flagged. See Chapter 2 measuring range of the “Flagging Test Results” system. for more details. Blood glucose may be lower than the measuring range of the system.
  • Page 62 The test strips will Blood glucose expire at the end of the is below the current month. Before defined hypo the end of the month, (low blood insert a new code chip glucose) level. from a new box of test strips and ensure the code chip number matches the code...
  • Page 63 If the message reappears, call the Accu-Chek Enquiry Line. The code chip is Not enough blood or incorrect. Turn off the control solution was meter and insert a new drawn into the test strip code chip.
  • Page 64 Make sure the time and Perform a blood glucose or date in the meter are control test. If the problem correct. persists, call the Accu-Chek Enquiry Line. Blood or control solution The temperature is above was applied to the test...
  • Page 65 Change settings may be the battery now. incorrect. Make sure the time and date are correct and adjust, if necessary. Note: • If you see any other error screen, please call the Accu-Chek Enquiry Line on 1800 251 816.

  • Page 66: Chapter 6: Technical Information

    Chapter 6: Technical Information Product Limitations Please read the literature packaged with your test strips to find the latest information on product specifications and limitations. Specifications Blood volume 0.6 µL Sample type Fresh whole blood Measuring time 5 seconds Measuring range 0.6 to 33.3 mmol/L Test strip storage conditions 2ºC to 32ºC...
  • Page 67 Interference from other electrically driven equipment is not to be anticipated. Performance Analysis The performance data for the Accu-Chek Performa system (Accu-Chek Performa meter with Accu-Chek Performa test strips) were obtained using capillary blood from diabetic patients (method comparison, accuracy), venous blood (repeatability) and control solution (reproducibility).
  • Page 68 Measuring 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. The sample and environmental conditions are also evaluated using a small AC signal.

  • Page 69: Product Safety Information

    Product Safety Information ▲ Strong electromagnetic fields may interfere with the proper operation of the meter. Do not use this meter close to sources of strong electromagnetic radiation. To avoid electrostatic discharge, do not use the meter in a very dry environment, especially one in which synthetic materials are present.

  • Page 70: Explanation Of Symbols

    Explanation of Symbols You may encounter the following symbols on packaging, on the type plate, and in the instructions for your Accu-Chek Performa meter, shown here with their meaning. Please consult instructions for use Caution (refer to accompanying documents). Please refer to safety-related notes in the manual accompanying this instrument.

  • Page 71: Guarantee

    Catalogue number For in vitro diagnostic use. Do not ingest! This product fulfills the requirements of Directive 98/79/EC on in vitro diagnostic medical devices. Listed by Underwriter’s Laboratories, Inc. © in accordance with UL 61010A-1 and CAN/CSA C22.2 No.1010-1. 3V type 2032 Guarantee The statutory guarantee provisions governing the sale of consumer goods in the country of purchase shall prevail.

  • Page 72: Additional Supplies

    Additional Supplies The following supplies and accessories are available from Diabetes Australia, pharmacies, or your surgical supplier: Accu-Chek Performa Test Strips Accu-Chek Performa Control Solutions Accu-Chek Softclix Lancing Device Accu-Chek Softclix Lancets Accu-Chek Multiclix Lancing Device Accu-Chek Multiclix Lancets References 1.

  • Page 73: Information For Healthcare Professionals

    Information for Healthcare Professionals ▲ Healthcare Professionals: Follow the infection control procedures appropriate for your facility. A drop of fresh, whole blood is required to perform a blood glucose test. Fresh venous, capillary, arterial, or neonatal blood may be used. Caution should be taken to clear arterial lines before blood is drawn.
  • Page 74 involving alternative site testing of adults with diabetes show that most persons will find their glucose level changes more quickly in the fingers’/palms’ blood than the alternative sites’ blood.* This is especially important when glucose levels are falling or rising rapidly. If your patient is used to making treatment decisions based upon fingertip/palm readings, he or she should consider the delay, or lag-time, affecting the reading obtained from an alternative site.

  • Page 75: Index

    Index alarm clock function, control test, acceptable high blood glucose, 25 setting, 35 range, 50 hyperglycemia, 25 control test, performing, 46 alternative site testing, 19, 71 hypoglycemia, 25 control test, results, 50 appetite, increased, 25 hypoglycemic alarm function, battery, changing, 53 control test results, setting, 39 understanding, 50...
  • Page 76 25 symbols, 68 technical information, 64 test results, unusual, 24 test strips, Accu-Chek Performa, 8, 13 thirst, increased, 25 time and date, setting, 29 tingling, 25 trembling, 25 troubleshooting, 57–63...
  • Page 79 Australia Patent Nos. 738325 and 591160. Australia Patent No. 591160 is licensed from Quadrant Holdings Cambridge Limited. Distributed by: Roche Diagnostics Australia Pty Ltd 31 Victoria Ave, Castle Hill, NSW 2154, Australia Accu-Chek Enquiry Line 1800 251 816...
  • Page 80 ACCU-CHEK ® Performa Roche Diagnostics GmbH, D-68298 Mannheim, Germany www.accu-chek.com Made in U.S.A. ACCU-CHEK, ACCU-CHEK PERFORMA, SOFTCLIX, and ACCU-CHEK MULTICLIX are trademarks of Roche. ©2006 Roche Diagnostics. All rights reserved. 04861612001-1006...

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