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  5. Operator's Manual

Accu-Chek Inform II Operator's Manual

Manual is about: In-Service Plan for Blood Glucose Testing

Summary of Inform II

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    Accu-chek ® inform ii blood glucose monitoring system operator’s manual.

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    2 revision history manual version revision date changes version 1.0 2008-01 new document version 2.0 2009-08 update, new sw version 02.00 version 3.0 2010-09 update, new sw version 03.00 version 4.0 2012-11 update, new sw version 03.04 (ots, ote), revision cleaning/disinfection section; misc. Editor...

  • Page 3: Operator’S Manual

    0 4807839001 (04) 2012-11 en operator’s manual version 4.0 aa ccu- ccu- c hek hek ® inform ii system.

  • Page 4: Ivd

    4 © 2008-2012, roche diagnostics. All rights reserved. The contents of this document, including all graphics, are the property of roche diagnostics. No part of this document may be reproduced or transmitted in any form or by any means, electronic or mechanical, for any purpose, without the express w...

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    5 1 introduction 11 1.1 before you start......................................................................................................................................... 11 intended use .............................................................................................................

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    6 3 patient glucose testing 39 3.1 information regarding blood glucose testing ................................................................................ 39 preparing to test ..........................................................................................................................

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    7 7 linearity testing 83 7.1 information regarding linearity tests................................................................................................. 83 linearity testing intervals ............................................................................................................

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    8 10 maintenance and care 127 10.1 conditions for storage and shipping ............................................................................................. 127 general operating conditions ................................................................................................... 12...

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    9 c supplement for other test entry 165 c.1 before you start...................................................................................................................................... 165 description ............................................................................................

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    10 this page intentionally left blank..

  • Page 11: Introduction

    Introduction • 1 11 1 introduction 1.1 before you start intended use the accu-chek ® inform ii system is intended for in vitro diagnostic use in the quantitative determination of blood glucose levels in venous, capillary, arterial, and neonatal whole blood samples for monitoring blood glucose. The s...

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    1 • introduction 12 if you need help information about using the system, the screen menus and performing a test can be found in this operator's manual. Error messages that appear on-screen include informa- tion or instructions on how to correct the error. For all questions about the accu-chek inform...

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    Introduction • 1 13 what can the system do for you? The accu-chek inform ii system has the following features and properties: ■ perform patient blood glucose tests and glucose control tests with control solution. ■ automatically record all relevant data for the appli- cation, which includes: – time ...

  • Page 14: 1.2

    1 • introduction 14 1.2 important safety instructions and additional information this section explains how safety-related messages and information related to the proper handling of the system are presented in the accu-chek inform ii manual. Please read these passages carefully. The safety alert symb...

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    Introduction • 1 15 important information regarding safety operator qualification only trained healthcare professionals may operate the accu-chek inform ii system. Operators must also have received comprehensive instruction in the operation, quality control, and care of the accu-chek inform ii syste...

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    1 • introduction 16 disposal of the system caution allergy or injury caused by reagents and other working solutions direct contact with reagents, detergents, cleaning/disin- fection solutions, or other working solutions may cause skin irritation or inflammation. ■ always use protective gloves. ■ obs...

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    Introduction • 1 17 product safety observe the following information to ensure product safety: ■ the system is suitable for continuous operation. General care accessory box meter ■ dispose of the meter in accordance with applicable laws and regulations. See “disposal of the system” on page 16. Autom...

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    1 • introduction 18 battery pack the meter contains a rechargeable battery pack that begins charging as soon as it is placed in an active base unit (i.E., one connected to a power supply). Observe the following general safety instructions for handling batteries: ■ when storing or disposing of the ba...

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    Introduction • 1 19 touchscreen laser scanner the built-in barcode scanner emits a laser beam when activated. The built-in barcode scanner is a class 1 laser, according to iec 60825-1/a2:2001. Electrostatic discharge (esd) the accu-chek inform ii system complies with both the electromagnetic immunit...

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    1 • introduction 20 electrostatic discharge (esd) is an electrical charge at rest, most commonly known as static electricity. If the accu-chek inform ii meter experiences a form of esd before or after running a blood glucose test, the test result will be stored in the meter memory and transmitted wh...

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    Introduction • 1 21 characteristics of strong passwords ■ passwords must not contain the user’s account name or parts of the user’s full name that exceed two consecutive characters. ■ passwords must be at least eight characters in length. ■ passwords must contain characters from at least three of th...

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    1 • introduction 22 radiofrequency radiation exposure information no operating limitations apply to meters without an rf card or to meters with an rf card that are not docked. Glossary: ■ “fcc” stands for “federal communications com- mission” (usa). ■ “rss” stands for “radio standards specification”...

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    Introduction • 1 23 the industrial, scientific and medical (ism) frequencies (802.11b and 802.11g use 2.4 ghz) may contain emis- sions from microwave ovens, heaters, and other noncom- munication devices. While these types of devices usually pose no threat of interference as they are low-powered devi...

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    1 • introduction 24 this device complies with part 15 of the fcc rules and with rss-210 of industry canada. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that...

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    Introduction • 1 25 note on systems with older hardware warning possibility of electromagnetic interference under certain conditions, a specific combination of hard- ware equipment may emit electromagnetic radiation of such high energy that it can interfere with the proper functioning of other elect...

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    1 • introduction 26 the accu-chek inform ii system complies with the emission and immunity requirements described in en 61326-2-6. It has been designed and tested to cispr 11 class a. In a domestic environment it may cause radio interference, in which case, you may need to take measures to mitigate ...

  • Page 27: 1.3

    Introduction • 1 27 1.3 system components the accu-chek inform ii system includes the following components and accessories: a meter b code key reader c base unit with power supply d accessory box (shown with consumables, not included) the system can be configured by two different methods: 1 configur...

  • Page 28: 1.4

    1 • introduction 28 1.4 overview of the meter the meter has the following elements: 1 test strip port insert the test strip here. 2 touchscreen (touch-sensitive display) this screen allows you to perform patient tests, per- form controls tests, and review results. To select any of these functions, s...

  • Page 29: 1.5

    Introduction • 1 29 1.5 overview of the code key reader test strip vials include a code key. 1 this code key is read by the code key reader and the data is sent to the meter. For additional information about the code key reader, see chapter 6. The code key reader has the following elements: 11 code ...

  • Page 30: 1.6

    1 • introduction 30 1.6 overview of the base unit to provide flexibility in line with customer requirements, two versions of the base unit are available. ■ the accu-chek inform ii base unit ■ the accu-chek inform ii base unit light both versions of the base unit can: ■ charge the meter battery pack....

  • Page 31: 1.7

    Introduction • 1 31 electrical connections are located on the back of the base unit (for a better view the removable wall mount is shown as transparent). For instructions on connecting the base unit, see chapter 9. 1.7 overview of the accessory box the accessory box provides an area for storing and ...

  • Page 32: 1.9

    1 • introduction 32 1.9 instructions for initial setup the meter must be configured prior to initial use. During this setup, the following parameters are configured: ■ date and time format ■ input mode for patient id ■ input mode for operator id ■ glucose controls: type and schedule ■ results screen...

  • Page 33: 2.1

    Powering up and entering an operator id • 2 33 2 powering up and entering an operator id 2.1 powering up the meter 1 press and release the on/off button . The meter is now on. 2 the power up screen appears. 3 check in the power up screen whether the date (lower left) and time (upper right) are displ...

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    2 • powering up and entering an operator id 34 adjusting the display using the display options, you can adjust display param- eters to your needs: ■ adjust the display contrast to the ambient light conditions. ■ set the time interval for activating the low power mode , which reduces the display cont...

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    Powering up and entering an operator id • 2 35 enabling/disabling the rf card if the unit is equipped with an rf card, you can temporar- ily enable or disable this functionality as required. The rf card is automatically reactivated the next time you power on the meter. You can then disable it again ...

  • Page 36: 2.2

    2 • powering up and entering an operator id 36 closing startup once you have completed all the necessary changes, ■ touch to proceed to the screen used to enter the operator id, or ■ wait 5 seconds and the meter automatically pro- ceeds to the screen used to enter the operator id. 2.2 entering the o...

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    Powering up and entering an operator id • 2 37 entering an operator id with barcode scanner when the screen for entering the operator id is displayed: 1 press and release . The button now appears with a black background (during the scan). 2 hold the meter so that the window of the barcode scanner is...

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    2 • powering up and entering an operator id 38 entering the operator id manually when the screen for entering the operator id is displayed: 1 touch the letters or numbers to enter the id. 2 use the following buttons to toggle between ranges of characters: – for letters a-o – for letters p-z – for nu...

  • Page 39: Patient Glucose Testing

    Patient glucose testing • 3 39 3 patient glucose testing 3.1 information regarding blood glucose testing preparing to test the following requirements must be met before you can perform a test: ■ the accu-chek inform ii test strips are available. ■ the code file for the test strip lot in use must be ...

  • Page 40: 3.2

    3 • patient glucose testing 40 3.2 performing a patient glucose test overview of test procedure a patient glucose test comprises the following steps: ■ enter the patient id. This can be done either man- ually or by using the barcode scanner. ■ confirm that the test strip lot matches the test strips ...

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    Patient glucose testing • 3 41 you now have three different options, depending on setup, for assigning the subsequent test to a patient. * depending on the dms you are using, this feature may be disabled. The patient id function can be configured by your system administrator to: ■ enter any combinat...

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    3 • patient glucose testing 42 entering the patient id manually use the displayed keypad to enter the patient id. You can select characters in the same manner as when entering an operator id. 1 touch the letters or numbers to enter the id. 2 use the following buttons to toggle between ranges of char...

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    Patient glucose testing • 3 43 selecting the patient id from a list choose the patient id from a list*, if a list has been down- loaded to the meter (from the data management system). 1 touch or to scroll up or down in the list. If one of the buttons is hidden, you have reached the top or bottom of ...

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    3 • patient glucose testing 44 entering a patient id with barcode scanner when the screen for entering the patient id is displayed: 1 press and release . The button now appears with a black background (during the scan). 2 hold the meter so that the window of the barcode scanner is approx. 10-20 cm (...

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    Patient glucose testing • 3 45 confirming or selecting the test strip lot once you have entered and confirmed the patient id, you are asked to choose the lot number for the test strips. Compare the number displayed by the meter to the number on the label of the test strip vial. 1 select the lot numb...

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    3 • patient glucose testing 46 inserting test strips after confirming the test strip lot, you are prompted to insert the test strip. 1 remove the test strip from the test strip vial and close the vial with the cap. 2 hold the test strip so the lettering “accu-chek” is facing upward. 3 slide the test...

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    Patient glucose testing • 3 47 applying a blood sample once the meter has detected the test strip, you are prompted to apply a blood sample. 1 wait until the flashing drop appears in the display before applying the blood. The meter beeps again. 2 apply the drop of blood to the front edge (yellow dos...

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    3 • patient glucose testing 48 results screen the hourglass icon indicates the test is running. When the test is completed and the result is ready, the meter beeps again. When the result is displayed, a message or warning may also appear (depending on system configuration) notify- ing you if the res...

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    Patient glucose testing • 3 49 the results screen contains a button that changes its name based on the result ( range or out of ... Range ). Touch this button to display the configured limit values. ■ the system measurement range refers to the measurement range of the system itself (strips and meter...

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    3 • patient glucose testing 50 the following messages may appear in addition to the standard test result: ■ cr lo (below the critical range threshold, but within the reportable range) ■ cr hi (above the critical range threshold, but within the reportable range) ■ rr lo (below the reportable range th...

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    Patient glucose testing • 3 51 adding comments you can add up to three comments to a test result. Comments can provide, for example, additional information about the test conditions or the patient. The meter can be configured so that comments are always required, required depending on the result ran...

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    3 • patient glucose testing 52 remove the test strip and dispose of it in accordance with applicable regulations and directives for disposal of potentially infectious samples and materials. Test results are also saved when the meter is powered off in the results screen or automatically powers off af...

  • Page 53: Glucose Control Testing

    Glucose control testing • 4 53 4 glucose control testing 4.1 information regarding glucose control tests observe the applicable regulations and directives of the responsible regulatory agencies when performing glu- cose control tests. See also safety message “allergy or injury caused by reagents and...

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    4 • glucose control testing 54 glucose control testing intervals intervals between running glucose control tests are determined by your facility. These intervals are entered when the system is configured. At the end of the speci- fied interval (or after a specific event such as starting to test with...

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    Glucose control testing • 4 55 information stored during glucose control testing the following information is stored for every glucose con- trol test using control solution: ■ glucose control test result ■ lot number of the control solution ■ operator id (if configured) ■ level of control solution (...

  • Page 56: 4.2

    4 • glucose control testing 56 4.2 performing glucose control tests overview of test procedure a glucose control test using control solution comprises the following steps: ■ select the desired level of control solution for the test. ■ check the lot number of the control solution. ■ check the lot num...

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    Glucose control testing • 4 57 starting a glucose control test after preparing the meter as described, you can proceed to the steps directly related to control testing: 1 from the main menu screen touch control test . In the control test screen, the levels available for the control solution are disp...

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    4 • glucose control testing 58 confirming or selecting the lot number for control solutions once you have selected the level, you are asked to con- firm or enter the lot number of the control solution. Com- pare the number displayed by the meter to the number on the label of the control solution. 1 ...

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    Glucose control testing • 4 59 confirming or selecting the test strip lot once you have entered and confirmed the lot number of the control solution, you are asked to choose the lot number for the test strips. Compare the number dis- played by the meter to the number on the label of the test strip v...

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    4 • glucose control testing 60 inserting test strips after confirming the test strip lot, you are prompted to insert the test strip. 1 remove the test strip from the test strip vial and close the vial with the cap. 2 hold the test strip so the lettering “accu-chek” is facing upward. 3 slide the test...

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    Glucose control testing • 4 61 applying the control solution once the meter has detected the test strip, you are prompted to apply the control solution. 1 wait until the flashing drop appears in the display before applying the control solution. 2 apply a drop of glucose control solution to the front...

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    4 • glucose control testing 62 results screen the hourglass icon indicates the test is running. When the test is completed and the result is ready, the meter beeps again. Depending on configuration, the result is displayed either as a value or only as a qualitative result pass or fail . Your system ...

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    Glucose control testing • 4 63 performing a stat test the meter can be configured to allow a stat patient glu- cose test to be run even if the meter is in qc lockout or download lockout. This option is to be used in situations with critical patients. The system administrator can allow control tests ...

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    4 • glucose control testing 64 this page intentionally left blank..

  • Page 65: Review Results

    Review results • 5 65 5 review results 5.1 displaying test results from the memory information stored in data records for test results when you retrieve the data record for stored test results, the following information is displayed. ■ patient id, glucose control, or sample id ■ the test result ■ th...

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    5 • review results 66 3 touch an entry in the list to display the related details. 4 touch patient , if you wish to display results for a specific patient only. – if you touch patient from the full list view, you will be asked to enter the patient id manually or via bar- code scanner. The list now c...

  • Page 67: 6.1

    Storing test strip, control solution, and linearity solution information in the meter • 6 67 6 storing test strip, control solution, and linearity solution information in the meter 6.1 storing information about test strips each box of test strips contains a code key. 1 each code key belongs to a sin...

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    6 • storing test strip, control solution, and linearity solution information in the meter 68 transferring code key information to the meter the following description assumes that the meter is pow- ered on and the main menu is displayed. 1 touch to open the main menu 2 screen. 2 touch strip lots to o...

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    Storing test strip, control solution, and linearity solution information in the meter • 6 69 5 place the code key reader on a level surface such as a bench. Hold the meter 10-15 cm (4-6 in) above the code key reader so that a connection can be made between the two infrared windows. 6 touch to begin ...

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    6 • storing test strip, control solution, and linearity solution information in the meter 70 information about the expiration date and parameters for control solutions is subsequently displayed. 1 touch to store the data for this lot number in the meter without changes, or 2 touch to modify the data...

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    Storing test strip, control solution, and linearity solution information in the meter • 6 71 the parameters for control solutions consist of four sepa- rate values. 5 use the keypad to enter the desired values one after another: – minimum limit value for level 1 – maximum limit value for level 1 – m...

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    6 • storing test strip, control solution, and linearity solution information in the meter 72 once you have finished updating the test strip informa- tion, you can use the next screen to select the lot number you are currently editing as the current lot number. 7 touch to confirm that you want this l...

  • Page 73: 6.2

    Storing test strip, control solution, and linearity solution information in the meter • 6 73 6.2 storing control solution information glucose control solution lot information can be entered before testing, if lot editing has been allowed at the meter level in the setup, and appears in a list for ope...

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    6 • storing test strip, control solution, and linearity solution information in the meter 74 4 select the level (l1/lo or l2/hi). 5 use the keypad to enter the lot number. Touch to confirm the entered lot number, or 6 press and release to read the lot number from the control solution bottle via barc...

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    Storing test strip, control solution, and linearity solution information in the meter • 6 75 once you have finished updating the control solution information, you can use the next screen to select the lot number you are currently editing as the current lot number. 9 touch to confirm that you want th...

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    6 • storing test strip, control solution, and linearity solution information in the meter 76 selecting a stored lot number as the current lot number you can select any stored lot number as the current lot number. 1 touch in the main menu to open the main menu 2 screen. 2 touch control lots to open t...

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    Storing test strip, control solution, and linearity solution information in the meter • 6 77 3 touch the lot number you wish to select as the cur- rent lot number. This opens the related detail view. 4 touch make current to make the lot number the current lot number. The information current is then ...

  • Page 78: 6.3

    6 • storing test strip, control solution, and linearity solution information in the meter 78 6.3 storing linearity test information observe the applicable regulations and directives of the responsible regulatory agencies when performing linearity tests. Entering the lot number of the linearity test ...

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    Storing test strip, control solution, and linearity solution information in the meter • 6 79 4 use the keypad to enter the lot number. 5 touch to confirm the entered lot number. 6 enter the expiration date (use two digits and lead- ing zero, if necessary) and touch to confirm the expiration date you...

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    6 • storing test strip, control solution, and linearity solution information in the meter 80 selecting a stored lot number as the current lot number you can select any stored lot number as the current lot number. 1 touch in the main menu to open the main menu 2 screen. 2 touch linearity lots to open...

  • Page 81

    Storing test strip, control solution, and linearity solution information in the meter • 6 81 3 touch the lot number you wish to select as the cur- rent lot number. This opens the related detail view. 4 touch make current to make this lot number the current lot number. The current information is then...

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    6 • storing test strip, control solution, and linearity solution information in the meter 82 this page intentionally left blank..

  • Page 83: Linearity Testing

    Linearity testing • 7 83 7 linearity testing 7.1 information regarding linearity tests observe the applicable regulations and directives of the responsible regulatory agencies when performing glu- cose control tests. See also safety message “allergy or injury caused by reagents and other working sol...

  • Page 84

    7 • linearity testing 84 information stored during linearity testing the following information is stored for every linearity test: ■ test result ■ lot number of the linearity solution ■ level of linearity solution (l1 to l6) ■ operator id (if configured) ■ lot number of the test strips ■ time and da...

  • Page 85: 7.2

    Linearity testing • 7 85 7.2 performing a linearity test overview of test procedure a linearity test comprises the following steps: ■ check the lot number of the linearity solutions. ■ check the lot number of the test strips. ■ perform the test with a minimum of three linearity solutions. Starting a...

  • Page 86

    7 • linearity testing 86 confirming or selecting the lot number for linearity test kits you are now prompted to confirm or enter the lot number of the linearity test kit. Compare the number displayed by the meter to the number on the label of the linearity test kit. 3 if you want to use the preselec...

  • Page 87

    Linearity testing • 7 87 in the linearity test menu, the levels available for the linearity test are displayed. 5 touch l1 to start the subsequent test with this (first) level. Inserting test strips after selecting the level, you are prompted to insert the test strip. 1 remove the test strip from th...

  • Page 88

    7 • linearity testing 88 applying a linearity test sample once the meter has detected the test strip, you will be prompted to apply the linearity solution. 1 wait until the flashing drop appears in the display before applying the solution. 2 apply a drop of the linearity solution to the front edge o...

  • Page 89

    Linearity testing • 7 89 results screen the hourglass icon indicates the test is running. When the test is completed and the result is ready, the meter beeps again. You can add comments to a test result (as with blood glucose tests, see page 51). If you do not wish to add a comment to the test resul...

  • Page 90

    7 • linearity testing 90 this page intentionally left blank..

  • Page 91: Proficiency Testing

    Proficiency testing • 8 91 8 proficiency testing 8.1 information regarding proficiency tests observe the applicable regulations and directives of the responsible regulatory agencies when performing proficiency tests. Blood glucose proficiency tests are run on samples whose values are unknown to the ...

  • Page 92

    8 • proficiency testing 92 information stored during proficiency testing the following information is stored for every proficiency test: ■ test result ■ sample id ■ lot number of the test strips ■ time and date of test ■ comments (if applicable) ■ operator id (if configured) preparing a proficiency ...

  • Page 93: 8.2

    Proficiency testing • 8 93 8.2 performing a proficiency test overview of test procedure a proficiency test comprises the following steps: ■ enter a sample id for the proficiency sample. ■ check the lot number of the test strips. ■ perform the actual test with the proficiency sample. Starting a profi...

  • Page 94

    8 • proficiency testing 94 entering the proficiency sample id you will now be asked to enter the sample id. 1 use the keypad to manually enter the sample id, or 2 press and release to read the sample id from the sample vial via barcode scanner (see page 37). Make sure in this case that the proficien...

  • Page 95

    Proficiency testing • 8 95 inserting test strips after confirming the test strip lot, you will be prompted to insert the test strip. 1 remove the test strip from the test strip vial and close the vial with the cap. 2 hold the test strip so the lettering “accu-chek” is facing upward. 3 slide the test...

  • Page 96

    8 • proficiency testing 96 applying a proficiency sample once the meter has detected the test strip, you are prompted to apply the proficiency sample. 1 wait until the flashing drop appears in the display before applying the sample. 2 apply a drop of sample to the front edge of the test strip. Do no...

  • Page 97

    Proficiency testing • 8 97 results screen the hourglass icon indicates the test is running. When the test is completed and the result is ready, the meter beeps again. The result is displayed as a numerical value, unless it falls outside the system measurement range. In this case, the message hi or l...

  • Page 98

    8 • proficiency testing 98 this page intentionally left blank..

  • Page 99: Initial Startup

    Initial startup • 9 99 9 initial startup 9.1 connecting the base unit 1 slide the base unit upward and remove it from the wall mount (if in use). 2 connect the power cord to the proper outlet. 3 if you want to connect the accu-chek inform ii base unit in a wired environment: connect the ethernet (rj...

  • Page 100: 9.2

    9 • initial startup 100 9.2 installing or replacing the battery pack when shipped, the battery pack is not installed in the accu-chek inform ii meter. After installing a new battery pack, the meter should be charged for three hours in the base unit before testing. Whenever the meter is in the base u...

  • Page 101

    Initial startup • 9 101 removing the battery pack 1 if a battery pack is already installed, make sure that the meter is switched off. 2 place the meter face down on a level surface. 3 using a torx screwdriver size t5, remove the two screws holding the battery pack in place. 4 carefully remove the ba...

  • Page 102

    9 • initial startup 102 installing the battery pack 1 loosen the screws on the battery pack until they are protruding about 4-5 mm (2/10 in). 2 position the battery pack alongside the meter so that the plug connector is level with the socket inside the meter. 3 plug the connector plug into the socke...

  • Page 103

    Initial startup • 9 103 5 place the tapering end of the battery pack on the small ledge of the opening and push down like a lid to close (as shown in the illustration below). Make sure that the plug connector wires slide into the groove provided for them on the battery pack. Gently pushing down the ...

  • Page 104

    9 • initial startup 104 8 place a ruler across the back of the meter to check that the battery pack is properly positioned. The ruler should lie completely flat, touching both sides of the meter on the left and right of the battery pack (see left image above). If this is not the case (as shown in th...

  • Page 105: 9.3

    Initial startup • 9 105 9.3 docking the meter docking the meter in the base unit allows you to charge the battery. When docked, the meter shows different messages according to the current meter status. The following displays are visible while the meter con- nects to the data management system and tr...

  • Page 106

    9 • initial startup 106 this display is visible when communication is still active but the meter is busy processing the data received or waiting for the next data message from the dms. This display is visible when no communication is taking place. This display is visible when software updates are be...

  • Page 107: 9.4

    Initial startup • 9 107 9.4 initial setup on the meter there are two ways to customize the setup of the meter: directly on the meter (see the following menu overview) or via the data management system (see appendix a). The two methods differ according to the range of options available. The meter is ...

  • Page 108

    9 • initial startup 108 menu overview the following tables contain a brief overview of the menu structure. The menus can be used to operate the meter fully and enter the most important basic settings. Main menu patient test observer login – enter observer id – enter observer password glucose test – ...

  • Page 109

    Initial startup • 9 109 main menu 2 maintenance – add comment – maintenance result proficiency – enter sample id – verify test strip lot – insert test strip – apply sample – view test results – add comments strip lots – view lot list – add lot – enter expiration date – set control ranges – view lot ...

  • Page 110

    9 • initial startup 110 admin menu admin – language – date/time – setup language – german – french – spanish – italian – dutch – swedish – english – danish – portuguese date/time – enter current date – enter current time setup menu date/time options – date/time editing – time format – date format te...

  • Page 111: 9.5

    Initial startup • 9 111 9.5 opening the setup menu all settings described here are configured via the setup menu . To open the setup menu , proceed as follows: 1 touch in the main menu to open the main menu 2 screen. 2 touch admin. To open the admin menu . 3 touch setup menu to open the setup menu ....

  • Page 112: 9.6

    9 • initial startup 112 9.6 date and time format use this menu to select the date and time format for the display. You can also choose whether the operator is allowed to edit date and time (optionally with password required). 1 touch the desired option to enable it: ■ date/time editing – allowed : e...

  • Page 113: 9.7

    Initial startup • 9 113 9.7 display options and optional tests use this menu to select the unit of measure for test results and enable or disable optional tests. 1 touch the desired option to enable it: ■ result units – mg/dl – mmol/l ■ enable tests – stat : stat tests may be performed. When this op...

  • Page 114: 9.8

    9 • initial startup 114 9.8 options for test strips this menu allows you to select options for handling lot numbers and specify whether the operator is allowed to edit the expiration date and limit values on the meter (optionally with password required). 1 touch the desired option to enable it: ■ re...

  • Page 115

    Initial startup • 9 115 on the second settings screen, you can select options for handling lot numbers with glucose control and linearity tests. 1 touch the desired option to enable it: ■ control lot verification – display only : the lot number is shown on-screen but the operator cannot confirm it o...

  • Page 116: 9.9

    9 • initial startup 116 9.9 options for glucose control tests this menu contains options that allow you to specify whether and at what intervals glucose control tests are performed. If you require control tests, check your set- tings for stat tests (see page 113). 1 touch the desired option to enabl...

  • Page 117

    Initial startup • 9 117 9.10 value ranges (normal, critical, reportable) this menu allows you to set limit values for results as normal , critical, or reportable . Results outside these limits will be flagged to alert you of this event. The reportable range allows the system administrator to set an ...

  • Page 118

    9 • initial startup 118 9.11 options for operator id entry this menu allows you to specify if and how operator login is performed. 1 touch the desired option to enable it: ■ operator entry – none : the meter can be used without operator login. – prompt or prompt (numeric only) : operator login is re...

  • Page 119: 9.12 Patient Id Options

    Initial startup • 9 119 9.12 patient id options this menu allows you to specify the criteria for entering a patient id. 1 touch the desired option to enable it: ■ patient entry – prompt or prompt (numeric only): the patient id can be entered manually via keypad or via barcode scanner. – scan only : ...

  • Page 120

    9 • initial startup 120 9.13 creating a setup password this screen allows you to create a password for all the settings described in this chapter. The password ensures that only authorized persons can make changes to the setup. 1 use the keypad to enter the password. 2 touch to save the password and...

  • Page 121

    Initial startup • 9 121 9.14 setting the date and time this setting can be hidden or require entry of a password, based on configuration. 1 touch in the main menu to open the main menu 2 screen. 2 touch admin. To open the admin menu . 3 touch date/time to begin entering the date. 4 enter the date fi...

  • Page 122: 9.15 Beeper Options

    9 • initial startup 122 9.15 beeper options this setting can be used to set the volume of the beeper. 1 touch in the main menu to open the main menu 2 screen. 2 touch beeper to set the volume. 3 touch the button with the desired volume. When you touch a button, the meter will beep at the correspondi...

  • Page 123: 9.16 Diagnostics View

    Initial startup • 9 123 9.16 diagnostics view under diagnostics you can find information about the system, such as software version, number of data records stored, and settings. Use this menu to display stored error messages and test the barcode scanner. 1 touch in the main menu to open the main men...

  • Page 124

    9 • initial startup 124 3 touch or to scroll between screens. 4 touch log to display stored error messages. 5 touch to test the barcode scanner. 6 touch to return to the main menu . Diagnostics 11/19/12 12:48 pm test authenticated: rf activated: associated: received ip: ip: subnet: gateway: dns: con...

  • Page 125

    Initial startup • 9 125 9.17 unlocking a download lockout when using a data management system for configura- tion, a download lockout can be configured. This lockout prevents a meter from being used for testing, if the meter data have not been downloaded for a defined period of time. If a download l...

  • Page 126

    9 • initial startup 126 this page intentionally left blank..

  • Page 127: 10 Maintenance and Care

    Maintenance and care • 10 127 10 maintenance and care 10.1 conditions for storage and shipping general operating conditions please observe the following points to ensure the reliable operation of your system over the long term: ■ handle the meter and its system components with care. Avoid dropping i...

  • Page 128

    10 • maintenance and care 128 storage ■ store the system and test strips in the same envi- ronment in which they are used. ■ do not store the meter in direct sunlight or under extreme temperature conditions. ■ observe the limits for temperature and humidity when storing and using the meter (see chap...

  • Page 129

    Maintenance and care • 10 129 acceptable cleaning/ disinfecting agents before using a cleaning/disinfecting solution on the meter, base unit, code key reader, or accessory box refer to the product labeling for required contact time for cleaning/disinfecting and to ensure that the active ingre- dient...

  • Page 130

    10 • maintenance and care 130 cleaning/disinfecting the meter ■ clean the meter to remove visible soil and organic material for safe handling and/or prior to disinfecting. ■ disinfect the meter when it is soiled and per your facility’s guidelines. Warning avoid getting liquid into the test strip por...

  • Page 131

    Maintenance and care • 10 131 how to clean/disinfect 1 remove the meter from the base unit prior to cleaning/disinfecting. 2 power off the meter. 3 place the meter on a level surface. 4 gently wipe over the surfaces (touchscreen, housing) with a soft, lint-free cloth slightly dampened (not wet) . If...

  • Page 132

    10 • maintenance and care 132 cleaning the barcode scanner window the barcode scanner window should be cleaned periodi- cally. Use a clean, dry cloth to wipe the barcode scanner window. Cleaning/disinfecting the base unit 1 unplug the base unit before cleaning/disinfecting. 2 wipe over the surfaces ...

  • Page 133

    Maintenance and care • 10 133 cleaning/disinfecting the accessory box for cleaning, you may wipe the surfaces with a soft cloth slightly dampened (not wet) with 70 % (or less) solution of isopropyl alcohol in water or with 70 % isopropyl alcohol, full strength. For disinfection: acceptable active in...

  • Page 134

    10 • maintenance and care 134 10.3 logging maintenance activities cleaning, disinfecting, and other maintenance activities can be logged in the meter. Make sure that all cleaning activities are complete and the system is thoroughly dry before switching on the meter. To store cleaning information in ...

  • Page 135: 11 Troubleshooting

    Troubleshooting • 11 135 11 troubleshooting the accu-chek inform ii meter continually checks its sys- tems for unexpected and unwanted conditions. A troubleshooting table follows that will help you when the system is not performing as expected. Most concerns can be resolved quickly by referring to t...

  • Page 136

    11 • troubleshooting 136 test result lo/hi the glucose result may be below (lo) or above (hi) the measurement range of the system. – refer to the package insert for the test strips. – check that you are performing the test correctly (see chapter 3). – run a glucose control test with a new test strip...

  • Page 137

    Troubleshooting • 11 137 meter displays glucose error detection of an unexpected hardware error – repeat the test or proceed according to the requirements of your facility. – run a glucose control test with a new test strip (see chapter 4). – press the on/off button on the top of the meter. – reset ...

  • Page 138

    11 • troubleshooting 138 automatic shutdown (power-off) the meter powers off after a configurable time without activity (e.G., pressing a key, touching the screen) to conserve energy. In addition, the meter may power off auto- matically for the reasons listed below. Reactivate the meter/ screen as d...

  • Page 139

    Troubleshooting • 11 139 error messages all error messages displayed by the system are accompa- nied by a description of the error and a possible solution. Take the action suggested on screen to resolve the problem. All messages, including purely informative messages, are preceded by a letter, ident...

  • Page 140

    11 • troubleshooting 140 – e : error; touch to confirm. To resolve the problem, take the actions suggested. – w : warning; touch to confirm. Sample message type description 1 2 3 operator id 12:48 pm 11/19/12 e-314: invalid scan. The scan returned an entry > 20 characters. Please see your system adm...

  • Page 141

    Troubleshooting • 11 141 meter reset a meter reset can be performed to correct a number of unspecified errors (e.G., “frozen” screen, etc.). Use the fol- lowing steps to perform a meter reset. 1 place the meter face down on a level surface. 2 press the reset button in the middle of the battery pack ...

  • Page 142

    11 • troubleshooting 142 this page intentionally left blank..

  • Page 143: 12.1 Technical Data

    General product information • 12 143 12 general product information 12.1 technical data * accu-chek inform ii base unit light: only red, green. Specification meter base unit power supply unit height 44 mm / 1.73 in (max.) 110 mm / 4.33 in (max.) 35 mm / 1.38 in + ac plug (28-40 mm / 1.1-1.6 in) widt...

  • Page 144

    12 • general product information 144 * not applicable to accu-chek inform ii base unit light specification meter base unit power supply unit battery voltage/type 3.7 volt rechargeable (lithium technology) n/a n/a input voltage +7.5 v dc +7.5 v dc 100 to 240 v ac input frequency dc dc 50 to 60 hz inp...

  • Page 145: 12.2 Further Information

    General product information • 12 145 12.2 further information ordering item description ref/catalog number accu-chek inform ii meter meter only 05060311001 accu-chek inform ii meter meter, equipped with rf card 05060303001 accu-chek inform ii base unit equipped with charging and connectivity functio...

  • Page 146

    12 • general product information 146 accu-chek inform ii operator’s manual and quick reference guide for additional copies of the accu-chek inform ii operator’s manual and quick reference guide or copies in other languages, please contact your local roche organization. Reagents and solutions supplie...

  • Page 147

    General product information • 12 147 information about software licenses this product incorporates software modules developed under open source licenses. The source code of this soft- ware can be requested on a standard data exchange medium from the manufacturer at the following address roche diagno...

  • Page 148

    12 • general product information 148 this page intentionally left blank..

  • Page 149: Appendix

    Appendix • a 149 a appendix a.1 table of configuration options this section provides an overview of all the settings available. The two rightmost columns describe the accessibility of a configuration parameter on the device ( setup menu ) and via the data management system (dms). “y” (yes) means, th...

  • Page 150

    A • appendix 150 custom comments 0: enabled 1: disabled 0 n y control lot verification 0: display only 1: yes / no confirmation 2: prompt for entry 3: scan only 1 y y control result display 0: value (numeric) 1: pass / fail 0 n y critical range display 0: value (numeric) 1: hi / lo 0 n y critical ra...

  • Page 151

    Appendix • a 151 linearity lot verification 0: display only 1: yes/no confirmation 2: prompt for lot entry 1 y y display low power mode time (only serial num- bers ≥ uu11030000) 0 - 120 sec (0 = low power mode off) 30 sec y y contrast 1 - 15 7 y y formats and language date format 1: mm/dd/yy 2: dd.M...

  • Page 152

    A • appendix 152 admin menu “setup” (if enabled, access to setup screens is possible) 0: disabled 1: enable 1 y y setup password 0 – 20 characters “” y y reagent editing allowed 1: allowed 2: password needed 0: not allowed 1 (y) y operator id operator id entry control 0: none 1: prompt 2: scan only ...

  • Page 153

    Appendix • a 153 patient id entry mode 0: keyboard / scan 1: list / keyboard / scan 2: scan only 3: prompt (numeric) 0 y y patient id validation (allowed characters: a-z, 0-9, “.” [period], “-” [hyphen]) 0: none 1: length 2: list 3: list allowing entry if not on list 4: length if numeric 0 y y patie...

  • Page 154

    A • appendix 154 qc time of day 6 poct1-a data fields 00:00 – 23:59 06:00 09:00 12:00 15:00 18:00 22:00 n y qc time of day set 6 poct1-a data fields 0 or 1 1 0 0 0 0 0 n y result deletion result deletion algorithm. Automatic or first in first out. 0: automatic 1: fifo 1 n y result retention time (nu...

  • Page 155

    Appendix • a 155 dms port (the port number to request open socket from the dms. Roche recom- mends use of port numbers 1024.) 0 – 65,535 0 n y dns ip (ip address of the dns-server if dhcp is not used and dns is configured) 0.0.0.0 – 255.255.255.255 0.0.0.0 n y gate ip (static gateway ip address) 0.0...

  • Page 156

    A • appendix 156 wpa key type 0: passphrase 1: key 0 n y wpa key string of 64 characters (hex) “0000000000 0000000000 0000000000 0000000000 0000000000 0000000000” n y wpa pass phrase (un-encrypted text used to generate the 256-bit preshared key.) 8 – 63 characters “” n y subject/attribute range defa...

  • Page 157

    Appendix • a 157 allowed combinations of cipher and security type security_type cipher_type wep_auth_type wep_key wpa_key_type wpa_key wpa_passphrase 0 - open 0 - none - - - - - 1 - wep 4 - wep40 0 - open / 1 - shared 10 charac- ters hex - - - 1 - wep 5 - wep104 0 - open / 1 - shared 26 charac- ters...

  • Page 158: A.2

    A • appendix 158 operator and patient id barcode masks a.2 example of barcode symbologies barcode mask character definition a-z, 0-9 if not preceded by the caret (“^”), the scan data character must be the same as the mask character. This character is not saved as part of the id. If the characters ar...

  • Page 159: Appendix

    Appendix • b 159 b appendix b.1 option: wireless network (wlan) preliminary note appendix b has been developed to explain the wireless communication protocols of the accu-chek inform ii system 1 . The connectivity specifications described in this section are designed to assist your facility’s inform...

  • Page 160

    B • appendix 160 the accu-chek inform ii meter uses a burst-like commu- nication protocol that will only consume bandwidth if there is actually data to be transferred. Compared to other applications, such as voice over internet protocol (voip) or multi-media applications, the meter’s band- width con...

  • Page 161

    Appendix • b 161 the current rf card consists of an antenna and a wlan system-on-chip (soc) along with other components. The wlan system-on-chip is the core of the wlan system. The rf card used in the accu-chek inform ii specifically adheres to the following specifications: ■ its wlan system-on-chip...

  • Page 162

    B • appendix 162 rf specific functionalities and effective performance claims the accu-chek inform ii system includes an optional module for wireless network connectivity (rf card). This module can only be configured by a data management system (dms), which enables the meter’s wireless com- municati...

  • Page 163

    Appendix • b 163 ■ an accu-chek inform ii meter with an rf card and wireless enabled will communicate results after every test or, when the meter is idle; it will automat- ically attempt to communicate with the dms every 10 minutes. A typical range for direct connection between the accu-chek inform ...

  • Page 164

    B • appendix 164 this page intentionally left blank..

  • Page 165: C.1

    Supplement for other test entry • c 165 c supplement for other test entry c.1 before you start description the other test entry (ote) feature is designed to allow the professional user to document patient test results from certain off-meter tests or other related information (e.G., prescribed insuli...

  • Page 166: C.2

    C • supplement for other test entry 166 c.2 overview of other test entry (ote) introduction the other test entry (ote) feature allows you to enter patient results for the following tests: ■ pregnancy ■ visual urinalysis (ua) ■ rapid streptococcus ■ rapid drugs of abuse tests (dat) ■ fecal occult ■ g...

  • Page 167

    Supplement for other test entry • c 167 in the review results listing, the test names for the above tests and insulin information will be abbreviated as follows: ■ pregnancy (preg) ■ visual ua (vua) ■ rapid strep (strep) ■ rapid dat (dat) ■ fecal occult (f occ) ■ gastric occult (g occ) ■ ketones (ke...

  • Page 168

    C • supplement for other test entry 168 entering patient test results using the other test entry feature comprises the following steps: ■ enter the patient id. ■ enter the date and time the test was performed. ■ enter or confirm the test strip, kit and/or other reagent lot numbers. ■ enter the test ...

  • Page 169: C.3

    Supplement for other test entry • c 169 c.3 recording other patient tests the following steps must be completed already: ■ the meter is powered on. ■ you have entered your operator id. ■ you have completed login by selecting and the main menu screen is displayed. 1 from the main menu screen touch pa...

  • Page 170

    C • supplement for other test entry 170 3 touch or to scroll up or down in the list. 4 select the desired test from the display list. Other patient tests 12:48 pm 11/19/12 pregnancy visual ua (ms) visual ua (cs) rapid strep rapid dat other patient tests 12:48 pm 11/19/12 intermediate-acting insulin ...

  • Page 171

    Supplement for other test entry • c 171 5 enter or select the patient id . Touch to pro- ceed to the next screen 1 . 6 use the keypad to enter the date the test was per- formed. For single digit numbers, add a leading zero. Touch to proceed to the next screen. 7 use the keypad to enter the time the ...

  • Page 172

    C • supplement for other test entry 172 8 use the keypad or barcode scanner to enter the fecal card lot number, and touch to proceed to the next screen. Or, if configured: ■ touch to confirm that you want to use the preselected lot number displayed by the meter. ■ touch to enter a new lot number, if...

  • Page 173

    Supplement for other test entry • c 173 10 use the keypad or the barcode scanner (if a bar- code is available) to enter the fecal developer lot number, and touch to proceed to the next screen. Or, if configured: ■ touch to confirm that you want to use the preselected lot number displayed by the mete...

  • Page 174

    C • supplement for other test entry 174 12 select the result of the positive control as accepta- ble or not acceptable by touching the appropriate button. 13 select the result of the negative control as accept- able or not acceptable by touching the appropriate button. 14 select the patient test res...

  • Page 175

    Supplement for other test entry • c 175 once the result(s) are entered, the fecal occult pat. Result screen is displayed. 15 to change an entry or a result, touch the appropriate button. To add comments 1 : 16 in the result screen, touch . 17 select the desired predefined comment from the display li...

  • Page 176: C.4

    C • supplement for other test entry 176 c.4 recording other control tests introduction the other control tests feature allows you to enter liquid control results for the following ote tests: ■ pregnancy (preg) ■ visual ua (vua) ■ rapid strep (strep) ■ rapid dat (dat) running controls ensures that yo...

  • Page 177

    Supplement for other test entry • c 177 entering control test results using the other control tests menu comprises the following steps: ■ select the type of control to be recorded. ■ enter the date tested (if required). ■ enter the time tested (if required). ■ enter or confirm the kit or test strip ...

  • Page 178

    C • supplement for other test entry 178 the following steps must be completed already: 1 the meter is powered on. 2 you have entered your operator id. 3 you have completed login by selecting and the main menu screen is displayed. 1 from the main menu screen touch control test . 2 from the control te...

  • Page 179

    Supplement for other test entry • c 179 5 use the keypad or the barcode scanner (if a bar- code is available) to enter the pregnancy ctrl lot number. Touch to proceed to the next screen. 6 use the keypad to enter the pregnancy ctrl lot expiration date. Touch to proceed to the next screen. 7 use the ...

  • Page 180

    C • supplement for other test entry 180 9 use the keypad or the barcode scanner (if a bar- code is available) to enter the pregnancy kit lot number. Touch to proceed to the next screen. 10 use the keypad to enter the pregnancy kit lot expiration date. Touch to proceed to the next screen. 1 2 3 4 5 6...

  • Page 181

    Supplement for other test entry • c 181 11 select the result of the control bar test as accepta- ble or not acceptable by touching the appropriate button. 12 select the result of the liquid control test (ctrl result) as acceptable or not acceptable by touching the appropriate button. Once the result...

  • Page 182

    C • supplement for other test entry 182 warning messages the meter may display error or warning messages when you enter other patient tests and other control tests . These error or warning messages occur when the validity of the recorded result is questionable. These messages caution that test infor...

  • Page 183: C.5

    Supplement for other test entry • c 183 c.5 reviewing other test results the other test results screen displays all stored ote results. Results can be viewed in three ways: all , patient , or qc . The following steps must be completed already: 1 the meter is powered on. 2 you have entered your opera...

  • Page 184

    C • supplement for other test entry 184 3 touch or to scroll up or down in the list. The results are grouped by date. 4 touch an entry in the list to display the related details. 5 touch or to display all available pages of a test result. Other test results 11/19/12 12:48 pm patient qc all -- 11/19/...

  • Page 185

    Supplement for other test entry • c 185 6 touch patient , if you wish to display results for a specific patient only. – if you touch patient from the full list view, you will be asked to enter the patient id manually or via bar- code scanner. The list now contains only the results for the selected p...

  • Page 186: C.6

    C • supplement for other test entry 186 c.6 other test entry configuration options other test entry options can only be configured using a dms. The availability of configuration options will thus vary according to the data management software utilized by your institution. Consult your system adminis...

  • Page 187

    Supplement for observed test sequence • d 187 d supplement for observed test sequence observed test sequence (ots) the observed test sequence (ots) function allows an observer (supervisor) to assess and record an operator’s performance (e.G., for recertification purposes). The observer monitors an o...

  • Page 188

    D • supplement for observed test sequence 188 using the ots function a request for an observed test sequence comes from the dms. Observer: 1 touch patient test . In the patient test menu , the glucose test button is grayed out (disabled) until the observer has logged in. 2 touch observer login . 3 w...

  • Page 189

    Supplement for observed test sequence • d 189 operator: 1 touch glucose test . Perform the patient test as usual. Once the test is com- pleted, the observer has to complete the next steps. 2 hand the meter back to the observer. Observer: 3 touch to log in again. 4 after you enter your password, touc...

  • Page 190

    D • supplement for observed test sequence 190 this page intentionally left blank..

  • Page 191: Index

    Index 191 index a accessory box cleaning/disinfecting ................................. 133 overview .............................................................31 adresses (roche) ................................................. 147 automatic power-off ...............................................

  • Page 192

    Index 192 i icons identification plate ............................................4 packaging ............................................................4 information service .............................................. 147 initial startup ...................................................99 – ...

  • Page 193

    Index 193 sample applying ....................................... 47 , 61 , 88 , 96 screen backlight ............................................................34 contrast ..............................................................34 setup .............................................107 – 122 ,...

  • Page 194

    Index 194 this page intentionally left blank..

  • Page 195

    195.

  • Page 196

    0 4807839001 (04) 2012-11 en c accu-chek, accu-chek inform, accu-chek performa and cobas are trademarks of roche. M roche diagnostics gmbh sandhofer strasse 116 68305 mannheim, germany www.Roche.Com www.Accu-chek.Com.