Table of Contents
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A
C
CCU-
HEK
®
Integra
BLOOD GLUCOSE MONITORING SYSTEM
0088
ACCU-CHEK, ACCU-CHEK INTEGRA and SOFTCLIX
are trademarks of Roche.
Complete
Instructions
Roche Diagnostics Australia Pty Ltd.
31 Victoria Avenue
for Use
Castle Hill, NSW 2154
Accu-Chek Enquiry Line: 1800 251 816
www.accu-chek.com
Roche Diagnostics GmbH
D-68298 Mannheim, Germany
www.accu-chek.com
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Table of Contents
Troubleshooting
Related Manuals for Accu-Chek Integra
Summary of Contents for Accu-Chek Integra
- Page 1 CCU- ® Integra BLOOD GLUCOSE MONITORING SYSTEM 0088 ACCU-CHEK, ACCU-CHEK INTEGRA and SOFTCLIX are trademarks of Roche. Complete Instructions Roche Diagnostics Australia Pty Ltd. 31 Victoria Avenue for Use Castle Hill, NSW 2154 Accu-Chek Enquiry Line: 1800 251 816 www.accu-chek.com...
- Page 2 Instructions for use for the Accu-Chek Softclix lancing device. For in vitro diagnostic use Part 3 Store at Instructions for use for the Accu-Chek Softclix AST cap, used to collect blood from alternative sites (accessory for the Accu-Chek Softclix Use by/Expiry date lancing device).
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Page 3: Table Of Contents
The Accu-Chek Integra meter is intended for use by one person Contents only. Use of the same Accu-Chek Integra meter by more than one person or for performing blood glucose measurements in more than one person poses an infection risk. - Page 4 Contents Contents Using the Accu-Chek Integra meter as an electronic Part 2 Accu-Chek Softclix Lancing Device notebook Instructions for Use 5.1 Memory 5.2 Viewing test results Introduction 5.3 Highest value, lowest value, average 11.1 Your lancing device at a glance 5.4 Downloading data to a PC or handheld computer...
- Page 5 13.2 Important information for users Patents AST testing Local customer support and service 14.1 Preparing for AST testing 19.1 Information and repair 14.2 Measuring blood glucose 19.2 Contact us Cleaning the Accu-Chek Softclix lancing device Alphabetical index and the AST Cap...
- Page 6 Part 1 CCU- ® Integra BLOOD GLUCOSE METER User’s Manual...
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Page 7: Introduction
Introduction Your blood glucose meter at a glance SET button Press this button to enter the Set menu and change the settings. Display window ON/OFF button Press this button only if you want ... - Page 8 1.1 Your blood glucose meter at a glance Battery compartment cover* Type plate Infrared window Battery compartment Batteries: Type AAA, LR 03, AM 4, Micro Test strip guide Control window (shows the number of strips remaining) ...
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Page 9: Main Features
Automatic coding Downloading data to a PC Every test strip drum has its own bar code. The Accu-Chek Integra blood The Accu-Chek Integra blood glucose meter has an infrared interface glucose meter is automatically coded when you insert a new drum,... -
Page 10: About This Manual
About this manual This manual will help you get to know your new Accu-Chek Integra We recommend that you start by familiarizing yourself with all of the meter step by step. It will provide you with all the information you need elements of your Accu-Chek Integra meter shown on pages 10 –... -
Page 11: Initial Steps Before Testing
Blood glucose results can be displayed in two different units (mmol/L or mg/dL). Consequently, Roche sells two different versions of the same Check that your Accu-Chek Integra Blood Glucose Monitoring Kit is com- meter. Check that your meter displays the unit you are accustomed to. -
Page 12: Inserting Or Replacing The Batteries
Inserting or replacing batteries If the meter is on, turn it off. Remove any used batteries. Press lightly on the lid of the battery compartment Insert two batteries (type AAA, LR 03, AM 4 or Micro). Make sure ... - Page 13 2.3 Inserting or replacing batteries Fold the lid of the battery compartment down and slide it closed A new set of batteries provides enough power to carry out a again. minimum of 500 blood glucose tests. There will be an audible CLICK as it closes. Do not use rechargeable batteries.
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Page 14: Performing A Full Display Test
Never throw batteries into a fire. This is dangerous because the display screen of your meter with the one shown below. they may explode. Remove the batteries if your Accu-Chek Integra meter is to remain unused for some time. mmol/L... -
Page 15: Inserting Or Replacing The Test Strip Drum
Inserting or replacing the test strip drum 2.4 Performing a full display test Release the MEMO button. Read the package insert that came with the test strip drums. If the meter is on, turn it off. The standard display test screen that is shown each time the meter Wait for the motor to stop before you open the meter. - Page 16 2.5 Inserting or replacing the test strip drum Slide the release button on the right side of the meter in the To exchange the drum, first tip the meter upright. The old drum drops out. direction indicated by the arrow. The drum compartment opens. You can dispose of used drums with your regular household waste.
- Page 17 2.5 Inserting or replacing the test strip drum Insert the new test strip drum. A dot appears in the small control window on the reverse side of the meter. This dot indicates that you have just inserted a drum. When you Close the drum compartment.
- Page 18 (see Chapter 6 “Checking the Accu-Chek If you do not insert a new test strip drum, the Integra meter”). You may, for instance, wish to stick the peel-off following message will be displayed the next time label in your notebook or diary. When conducting quality con-...
- Page 19 “CTRL” disappears from the display. The drum symbol continues to flash a quality control test in order to check the test strips. Carry out a quality control check (see Chapter 6 “Checking the Accu-Chek Integra meter”). in order to draw attention to the fact that the meter cannot calculate the use-by period.
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Page 20: Basic Settings
Press the SET button to call up the SET menu. The field currently flashing in the menu may now be changed. When you turn on your Accu-Chek Integra meter for the first time, it has Press the MEMO button to change the current setting. ... -
Page 21: Turning The Beep Tone On Or Off
Turning the beep tone on or off With the beep tone turned on, the meter beeps Press the MEMO button to turn off the beep tone. “OFF” appears in the display. when it asks you to apply blood or control solution, ... -
Page 22: Setting The Year
Setting the year If you have a new meter or you have just replaced the batteries, the date If you wish to define the time and date format, leave the meter turned will be set to 00.00.2000, and the time to 00:00 hours (24-hour format) on and proceed to the next section, 3.3. -
Page 23: Changing The Time/Date Format
results that are saved with the time and date will be included displayed. 24-hour format is selected. in the statistics (see Chapter 5 “Using the Accu-Chek Integra The time is set to 00:00. meter as an electronic notebook”). ... -
Page 24: Setting The Time
Setting the time Check the meter is off. Press the SET button again. The minute field flashes. Press the SET button. The meter turns on without advancing a test strip from the drum. Press the SET button repeatedly until the ... -
Page 25: Setting The Date
Setting the date Check the meter is off. Press the SET button again. The day field flashes. 24-hour format: DD-MM Press the SET button. 12-hour format: MM-DD The meter turns on without advancing a test strip from the drum. Press the SET button repeatedly until the month ... -
Page 26: Testing Blood Glucose
Testing blood glucose The Accu-Chek Integra meter is intended for use by one person Wash your hands thoroughly with warm water and soap and dry only. them well. Use of the same Accu-Chek Integra meter by more than one Open the display cover. - Page 27 If you hold it with the test strip cal customer support and service centre. pointing upwards, blood may enter the meter and contaminate Use the Accu-Chek Softclix lancing device to prick the side of a fingertip. Gently squeeze the fingertip to develop a small drop of blood (please turn to Part 2 and read the instructions for using the Accu-Chek Softclix lancing device).
- Page 28 Testing blood glucose Touch the blood drop against the front edge of the test strip near As soon as a sufficient amount of blood has been drawn up, the meter beeps and the test commences automatically. 000 appears in the dis- the black notch without delay.
- Page 29 Testing blood glucose Hold the meter upright over a waste bin. If you do not turn off the meter, it turns off automatically after about 60 seconds. The test strip then remains in the meter. Press the ON/OFF button. ...
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Page 30: Plausible Results
Plausible results Implausible results Your Accu-Chek Integra meter measures blood glucose within a defined If your meter repeatedly displays error messages, or if you have reason range (0.6-33.3 mmol/L). to doubt the validity of a test result, please check the following points. -
Page 31: Using The Accu-Chek Integra Meter As An Electronic Notebook
The meter turns on without advancing a test strip from the drum. The most recent test result and Your Accu-Chek Integra meter has a 100-value memory for saving re- “MEMO” are displayed. sults together with time and date (provided the latter are correctly set). -
Page 32: Highest Value, Lowest Value, Average
Highest value, lowest value, average Your meter can display the highest and lowest blood glucose results and Press the MEMO button again. the average (or mean) of current test results. Statistics are based on the The highest measured test result is displayed test results stored for the last 7 days, as long as they were saved with together with the time and date. -
Page 33: Downloading Data To A Pc Or Handheld Computer
Roche Diagnostics offers a variety of special software programs (e.g. Accu-Chek Compass, Accu-Chek Pocket Compass and Accu-Chek Camit Pro) to expand the memory functions in your Accu-Chek Integra meter. Such programs enable you and your doctor to manage your data more effectively and, through graph and table views, make it easier for you to understand your self-testing data. -
Page 34: Checking The Accu-Chek Integra Meter
The meter automatically downloads all stored blood glucose test results to your computer. The two arrows Do this by running a quality control check using Accu-Chek Integra flash in the display during the download. Control solution (not supplied with the meter): ... -
Page 35: Performing A Quality Control Check
Performing a quality control check Read the package insert that came with the control solutions. You now have approximately 5 minutes in which to apply control solu- tion. After this time the meter automatically turns off. This strip can no Open the display cover. - Page 36 Has the control solution been open for more than three months? Once opened, control solutions are stable for three months. They must not be used after this period. Did you use the correct quality control solution (Accu-Chek Integra Control)?
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Page 37: Cleaning The Accu-Chek Integra Meter
Cleaning the Accu-Chek Integra meter 6.2 Performing a quality control check The Accu-Chek Integra meter utilizes an optical measuring method that If you are unable to identify or eliminate the source of the problem relies heavily on all of its components being clean. Owing to the way the please contact Customer Support (see Chapter 19 for details). - Page 38 Cleaning the Accu-Chek Integra meter Clean the meter carefully, if Clean the small window covering the optical system, its surround- ings and the test strip guide carefully with a lightly moistened cot- the test strip guide has become visibly soiled, ton swab or a soft, lint-free cloth.
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Page 39: Measurement And Storage Conditions
When testing blood glucose, pay close attention to the following points. Make sure that no liquid enters the meter itself and avoid They affect the dependability of your Accu-Chek Integra meter and the scratching the measurement optics, as this will impair the accuracy of your results. -
Page 40: Atmospheric Humidity
Never try to speed up warming or cooling of your Accu-Chek are present. Integra meter artificially (e.g. by placing it on a radiator or in a refrigerator). Doing so can damage your meter and cause it to give incorrect results. Incorrect results can cause the wrong therapeutic decision to be taken and so produce adverse health effects. -
Page 41: Display Messages And Troubleshooting
Display messages and troubleshooting Messages and symbols When you use your Accu-Chek Integra meter, various letters and sym- When symbols and numbers are surrounded by a halo, it indicates that bols will appear on the display and also at times error messages. Some they are flashing in the meter’s display. -
Page 42: Messages And Symbols
9.1 Messages and symbols This message/ This message/ symbol appears ... and means: symbol appears ... and means: The test is in progress. You are requested to run a quality control test. CTRL This is/was a quality control test. CTRL The temperature during testing is at the limits of MEMO indicates a value saved in memory. - Page 43 Accu-Chek When the batteries are so weak that no more Integra Control solution and a new test strip. tests can be performed, the battery symbol ap- Repeat the blood glucose test. If you feel the new pears briefly for 3 seconds in the display.
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Page 44: Troubleshooting
Troubleshooting When symbols and numbers are surrounded by a halo, it indicates that This message/ they are flashing in the meter’s display. symbol appears ... and means: The test strip drum in the meter is empty. If this happens ... it means: Insert a new drum. - Page 45 You changed the batteries without changing ent blood glucose monitoring system. the test strip drum at the same time. Turn the meter off. Insert an Accu-Chek You performed the requested quality control Integra test strip drum. check and flagged it as such.
- Page 46 9.2 Troubleshooting This message/ This message/ symbol appears ... and means: symbol appears ... and means: If you inserted the second or third drum If the message is still displayed, please from a pack, press the SET button. The contact Customer Support (for details meter uses the bar code from the first see Chapter 19).
- Page 47 9.2 Troubleshooting This message/ This message/ symbol appears ... and means: symbol appears ... and means: A test error has occurred. The test strip is stuck in the guide. Turn the meter off and on again. Repeat the test. Turn the meter off. Pull the strip out of the meter. Open the drum compartment and remove the drum.
- Page 48 The two arrows do not start to flash. The meter Clean the optical system (see Chapter 7 turns off after 5 minutes and the computer dis- “Cleaning the Accu-Chek Integra meter”) plays a download-related error message. and repeat the test.
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Page 49: Technical Data
Decrease the distance between the infrared package insert that came with the windows of the two devices to less than Accu-Chek Integra test strip drums. 10 cm. Measuring range 0.6–33.3 mmol/L (10–600 mg/dL) Make sure the two infrared windows are Sample size Approx. - Page 50 Technical data Humidity Electromagnetic compatibility This device meets the electromag- Less than 85 % relative humidity netic immunity requirements as per Memory capacity 100 test results with time and date, ISO 15197 Annex A. The chosen average, highest and lowest blood basis for the immunity tests was glucose reading basic standard IEC 61000-4-2.
- Page 51 Part 2 CCU- ® Softclix Lancing Device Instructions for Use...
- Page 52 Introduction 11.1 Your lancing device at a glance Comfort Dial (for depth selection) Notch Protective cap Lancet Lancet holder Semi-circular cut-out Ejector Transparent release button Priming button...
- Page 53 11.2 About the Accu-Chek Softclix lancing device Using the Accu-Chek Softclix lancing device The Accu-Chek Softclix lancing device is an easy-to-use lancing device 12.1 Inserting or exchanging the lancet that has been specially developed to allow virtually pain-free collection of capillary blood from a fingertip or earlobe.
- Page 54 The penetration depth is set by rotating the Comfort Dial (cap). If you are using the Accu-Chek Softclix lancing device for the first time, set the depth selection dial to 1.
- Page 55 12.4 Cleaning the Accu-Chek Softclix lancing device Clean the Accu-Chek Softclix lancing device weekly using a cloth moist- Gently massage the fingertip or earlobe to encourage a drop of blood to ened with water or 70 % alcohol (available from your pharmacist).
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Page 56: Instructions For Use
Part 3 CCU- ® Softclix AST ACCESSORY Clear plastic AST cap for blood glucose determination with Accu-Chek Integra on alternative sites Instructions for Use... -
Page 57: Introduction
Traditionally, blood samples for blood glucose testing are taken from the the risk of infection. fingertip or from the earlobe. With the Accu-Chek Integra system, you now also have the option of using capillary blood samples from other To avoid infection, use a new lancet each time you take blood. -
Page 58: Important Information For Users
13.2 Important information for users 13.1 A new way to test Before you perform a test with blood from an alternative site, you should Alternative Sites for Testing be aware of the following limitations: Capillary blood from the fingertip responds more quickly to changes in blood glucose levels than blood from alternative sites. - Page 59 13.2 Important information for users If you are considering AST for your glucose measurements, please Pre-test Checklist discuss this first with your healthcare professional. If the displayed blood glucose result does not match how you feel, you should do a fingertip test to check the result. If the fingertip result still does not match how you feel, contact your doctor.
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Page 60: Ast Testing
To obtain a sufficiently large drop of blood from alternative sites, lancing must be deeper than on the finger. 2. Insert a new Accu-Chek Softclix However, these sites are usually less lancet into the lancet holder and sensitive to pain and most patients push it in until it clicks. -
Page 61: Measuring Blood Glucose
14.2 Measuring blood glucose 14.1 Preparing for AST testing 1. Obtain a drop of blood as described 5. Choose a fleshy area of the alterna- above. tive site and wash it with warm, soapy water or use an alcohol wipe. 2. -
Page 62: Cleaning The Accu-Chek Softclix Lancing Device And The Ast Cap
Carefully dispose of used lancets to avoid injuries. BLOOD GLUCOSE MONITORING SYSTEM Never expose the Accu-Chek Softclix lancing device to extreme temperatures (e.g. in a hot car). Appendix Never dip the Accu-Chek Softclix lancing device in water or alcohol. ... -
Page 63: System Components
System components Guarantee With your Accu-Chek Integra meter use only Accu-Chek Integra test strip The statutory guarantee provisions governing the sale of consumer drums. The drums contain 17 test strips. Each drum comes individually goods in the country of purchase shall prevail. -
Page 64: Local Customer Support And Service
Roche Diagnostics Australia Pty Ltd. Information service 31 Victoria Avenue If you have any questions on how to use your Accu-Chek Integra meter Castle Hill, NSW 2154 or Accu-Chek Softclix lancing device or the AST cap, if any of the results... -
Page 65: Alphabetical Index
Alphabetical index Alternative sites ................112 Checking the meter ..............65 ff. Alternative site testing ..............109 ff. Cleaning AST cap ..............117 ff., 120, 122 Meter .................. 71 ff. Lancing device ..............107 Average .................. 60, 86 ff. AST cap ................. 120 Cleaning solution ............ - Page 66 Alphabetical index Electromagnetic interference ............77 Lancet ..............100, 103 f., 106, 122 Error messages ................84 ff. Lancing device ..............100 ff., 122 Expiry date, test strips ..............31 Lot code ................... 88 Lowest result ................. 60 f. Full display test ................. 25 Measurement conditions ...............
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Page 67: Alphabetical Index
Alphabetical index ON/OFF button .................. 10 Sample size ................15, 95 Optical system .................. 10 Service ..................124 f. Optical system, cleaning the optical system ........71 ff. SET button ..................10 Optical system, opening the optical system ........72 SET menu .................. - Page 68 Technical data ................95 ff. Temperature range ..............75 f., 95 Test strip drum, inserting or replacing ........... 27 ff. Test strip Ejection ................54 f. Guide ..................12 Symbol ..................79 Testing blood glucose ..............48 ff. Testing conditions ..............75 ff., 95 Thermometer symbol ................