Accu-Chek Inform II Operator's Manual
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Accu-Chek Inform II Operator's Manual

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Accu-Chek
®
Inform II
BLOOD GLUCOSE MONITORING SYSTEM
Operator's Manual
for meters with a serial
number greater than
or equal to UU14000000

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Summary of Contents for Accu-Chek Inform II

  • Page 1 Accu-Chek ® Inform II BLOOD GLUCOSE MONITORING SYSTEM Operator’s Manual for meters with a serial number greater than or equal to UU14000000...
  • Page 2 Revision History Manual versions 1, 2, 3 and 3.1 are for Accu-Chek Inform II meters with serial number versions UU13000000 to less than UU14000000. Manual versions 4, 5 and 6 are for Accu-Chek Inform II meters with serial number versions greater than or equal to UU14000000.
  • Page 3 CCU- CCU- Inform II System ® Operator’s Manual Version 6.0 08424705001 (01) 2017-04 USA...
  • Page 4 However, Roche Diagnostics reserves the right to make any changes necessary without notice as part of ongoing product development. If you have questions or comments about this manual please contact Accu-Chek Customer Care. ACCU-CHEK, ACCU-CHEK INFORM, ACCU-CHEK PERFORMA and COBAS are trademarks of Roche.
  • Page 5 Australian and New Zealand market. For other WLAN certifications, see label on bottom of battery compartment. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 6: What Is New In Publication Version 6.0? Sw 04.01

    The presentation of safety messages in this manual has been updated throughout. See section 1.2 “Important safety instructions and additional information”. Test principle Description of the test principle used by the meter. See page 18. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 7: Accu-Chek Inform Ii Base Unit

    (REF 05060290001) in this manual. An overview of the legacy Accu-Chek Inform II ■ Base Unit and technical information have been moved to Appendix F. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...
  • Page 8 This page intentionally left blank. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 9: Table Of Contents

    1.7 Overview of the Accu-Chek Inform II Base Unit Hub..............38 1.8 Overview of the accessory box ......................39 1.9 Reagents and consumables......................... 39 1.10 Instructions for initial setup........................40 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...
  • Page 10 Confirming or selecting the test strip lot................. 76 Inserting test strips .......................... 77 Applying the control solution....................... 78 Results screen ........................... 79 Performing a STAT test ........................81 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...
  • Page 11 Entering the proficiency sample ID ..................114 Confirming or selecting the test strip lot................114 Inserting test strips ........................115 Applying a proficiency sample....................116 Results screen ..........................117 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...
  • Page 12 Shipping............................146 Storage .............................. 147 10.2 Cleaning/disinfecting the Accu-Chek Inform II system............147 Guide to cleaning and disinfecting the Accu-Chek Inform II system ....... 148 Cleaning and disinfecting the meter..................148 Acceptable cleaning/disinfecting agents................149 What to clean/disinfect ....................... 150 Technical assistance ........................
  • Page 13 Appendix for Accu-Chek Inform II Base Unit (legacy version) F.1 Overview of the base unit with older hardware................. 235 F.2 Connecting the base unit (legacy version) ................237 F.3 Technical data ............................238 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...
  • Page 14 Limited Warranty ® Accu-Chek Inform II meter LIMITED WARRANTY ............239 Index 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 15: Introduction

    Glucose Monitoring System will consist of: Meter: Accu-Chek Inform II Meter ■ Test Strip: Accu-Chek Inform II Test Strip ■ Controls: Accu-Chek Inform II Control Solutions ■ Linearity: Accu-Chek Linearity Kit ■ 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 16: Important Information Regarding Use

    If dedicating blood glucose meters to a single patient is not possible, the meters must be properly cleaned and disinfected after every use following the guidelines provided in this manual (see section “Maintenance and Care”). 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 17: If You Need Help

    Illustrations in this manual show two different kinds of hands: Hand without glove Hand with glove A dashed arrow between screen illustrations indicates that some screens have been skipped in these illustrations. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 18: What Can The System Do For You

    The sample and environmental conditions are also evaluated using AC and DC signals. For more details, refer to the test strip package insert. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 19: Important Safety Instructions And Additional Information

    Important information that is not safety relevant is presented against a colored background (without a symbol). Here you will find additional information on correct use of the meter or useful tips. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 20: Important Information Regarding Safety

    Laboratories (BMBL)” found at http://www.cdc.gov/ biosafety/publications/bmbl5/ – “CLSI. Protection of Laboratory Workers From Occupationally Acquired Infections”; Approved Guideline - Fourth Edition. CLSI document M29-A4. Wayne, PA: Clinical and Laboratory Standards Institute; 2014. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 21: Disposal Of The System

    The system is suitable for continuous operation. ■ The system is not protected against the harmful ■ ingress of fluids (IP X0 rating according to IEC 60529). 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 22: General Care

    10 minutes of inac- tivity. The result will be flagged with a standard comment (“Result not confirmed”) when it is trans- mitted to the DMS. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 23: Shut Down Meter

    (i.e., one connected to a power supply). NOTICE Use only the specially designed battery pack provided by Roche Diagnostics. Using any other type of battery may damage the system. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...
  • Page 24 Handle and dispose of battery packs with care. Extreme temperatures reduce the charging capacity and usage period of the meter and the battery pack. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...
  • Page 25 On/Off but- ton, this indicates that the battery is empty. Return the meter to the base unit immediately for recharging. See Troubleshooting, “Low power icons” on page 165. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 26: Touchscreen

    08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 27: Electrostatic Discharge (Esd)

    08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 28: Wireless Connectivity

    WLAN but also could be near or at the same frequency and cause interference. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...
  • Page 29 RSS-210 of Industry Canada. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, (2) this device must accept any interference received, including interference that may cause undesired operation. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 30: Local Area Network: Protection From Unauthorized Access

    Base Unit as a PDF file (see page 178 of this manual). Or contact Accu-Chek Customer Care for technical assistance. Observe your own facility guidelines on password management where available, or apply the following rules: 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...
  • Page 31 UHXW13SF contains no lower case letter. ■ uxxxxx7F contains the same character more than ■ four times. x12useridF contains a substring of the user ID ■ longer than four characters. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 32: System Components

    Displays test results from patient tests and control ■ tests Transfers stored data to the data management ■ system via wireless communication (WLAN, optional) or the Accu-Chek Inform II Base Unit (LAN) 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 33: Overview Of The Meter

    These contacts are used to charge the battery pack when the meter is in the base unit. Infrared window Facilitates data communication with code key reader and base unit. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...
  • Page 34 If the meter supports wireless connectivity: This label displays registration numbers that are specific to the meter RF hardware. Interface (For manufacturer’s use only.) Battery pack connector socket Connect battery pack here. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 35: Overview Of The Code Key Reader

    You may get an error message on the meter. The code key is also frequently referred to as a code chip. The terms are synonymous. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 36: Overview Of The Accu-Chek Inform Ii Base Unit

    Inform II Base Unit only) The Accu-Chek Inform II Base Unit Light can support communication with a data management system only when used together with the Accu-Chek Inform II Base Unit Hub. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...
  • Page 37 For instructions on connecting the base unit, see Chapter 9. For an overview of the Base Unit with older hardware (REF 05060290001), see Appendix F, “Appendix for Accu-Chek Inform II Base Unit (legacy version)”. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 38: Overview Of The Accu-Chek Inform Ii Base Unit Hub

    Accu-Chek Inform II Base Unit Hub Operator’s Manual or the “Technical Note” stored on the Accu-Chek Inform II Base Unit as a PDF file (see page 178 of this manual). Or contact Accu-Chek Customer Care for tech- nical assistance.

  • Page 39: Overview Of The Accessory Box

    (L1 to L6). Your facility provides additional consumables such as blood collection supplies. Observe the current rules and safety guidelines for collecting and handling blood samples. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 40: 1.10 Instructions For Initial Setup

    For questions about using data management systems, contact Accu-Chek Customer Care (see Chapter 12). To ensure standardized configuration within a facility, the meter-based Setup Menu may be disabled. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 41: Powering Up And Entering An Operator Id

    . If the battery is nearly empty, the battery icon turns red 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 42: Adjusting The Display

    WLAN functionality of the Accu-Chek Inform II system using the guidelines of your facility. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...
  • Page 43 If this icon persists, contact your system administrator. Ignoring this information may lead to a Download Lockout (if configured, see page 48). 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 44: Closing Startup

    Barcode masking can be used to eliminate any charac- ters not belonging to the Operator ID. See information on “Operator and patient ID barcode masks” on page 192. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 45: Entering An Operator Id With Barcode Scanner

    This delay gives the operator time to position the bar- code scanner and/or the barcode properly, e.g., in case several different barcodes are located very close to each other such as in a list. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 46: Entering The Operator Id Manually

    (if config- ured). Enter the password manually in the same manner as described above for the operator ID. Once all entries are complete, the Main Menu appears. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 47: Patient Glucose Testing

    Wash hands thoroughly with soap and water before ■ putting on a new pair of gloves and performing the next patient test. Use an auto-disabling single-use lancing device for ■ each patient 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 48: Preparing To Test

    WLAN or by docking the meter in a base unit) does not happen within the specified time, the meter is locked (Download Lockout) and cannot be used for testing. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...
  • Page 49 Observe the applicable regulations and directives for ■ hygiene and safety when collecting blood samples. Observe the applicable regulations and directives for ■ disposing of potentially infectious samples and mate- rials. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 50: Performing A Patient Glucose Test

    Confirm that the test strip lot matches the test strips ■ in use (if configured). Perform the test. ■ Optionally a test may be categorized as an ■ Observed Test Sequence (see page 225). 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 51: Entering Or Selecting The Patient Id

    Enter or select the Patient ID as described on the following pages. If the function Patient Confirmation is enabled, verify and confirm the displayed patient informa- tion, after you entered or selected the ID. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...
  • Page 52 192. A list of supported barcode symbologies can be found in Appendix A.2. Depending on the DMS you are using, this feature may be disabled. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 53: Entering The Patient Id Manually

    ■ perform a test on the patient if the ID complies with the configured maximum/minimum length. However, the patient ID will not be automatically added to the list. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 54: Selecting The Patient Id From A List

    Name: Jane Doe ID: 3333333333 Main Menu. Name: Jenny Doe ID: 4444444444 Name: John Doe ID: 123456789 03/17/17 Depending on the DMS you are using, this feature may be disabled. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 55: Entering A Patient Id With Barcode Scanner

    The meter beeps once the barcode has been read suc- cessfully. The barcode information appears in the patient ID field. The barcode scanner turns off after 10 seconds, if a barcode is not scanned. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 56: Confirming Or Selecting The Test Strip Lot

    A glucose control test must always be performed before using a lot for the first time. 545777 Touch to confirm the selected or scanned lot 344654 number. 03/17/17 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...
  • Page 57 ■ (recommended), pick a previously entered lot number from the list, or ■ configure the meter to only display the lot number ■ (without confirmation by the operator). 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 58: Patient Identification Information

    DOB: 12/05/70 Strip Lot 545794 Strip Lot 545794 03/17/17 03/17/17 The DOB is not displayed on the patient test result screens, stored test results, or OTE test screens. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 59: Inserting Test Strips

    The meter beeps. The hourglass icon appears and indi- cates that the meter is checking the test strip. Do not apply blood while it is displayed. 03/17/17 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 60: Obtaining A Blood Sample

    Use an auto-disabling single-use lancing device for each patient. The lancing device must be intended for use by healthcare professionals in a multiple patient setting. Follow the manufacturer's instructions for use. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 61: Applying A Blood Sample

    Once a sufficient blood sample has been detected, the meter beeps and the measurement begins. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 62: Results Screen

    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. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...
  • Page 63 Glucose results within the Normal Range, as ■ defined by the institution, are considered normal and require no therapeutic action. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...
  • Page 64 CR LO or CR HI. All other results exceeding specified limit values will always be displayed as RR LO, RR HI, LO, or HI. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 65: Adding Comments

    You can call up the function for adding comments directly in the results screen. If com- ments are set as required, the meter will not accept an empty comment field. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...
  • Page 66 Use the keypad (as with login) to enter your comment(s). Once you have selected the desired comment(s), touch to return to the results screen. Touch to return to the Main Menu. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 67: Additional Patient Test

    This function is also available for OTS and OTE workflows. mg/dL Range Additional Patient Test D-531: Perform additional Patient Test for Patient ID 123456789? 03/17/17 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...
  • Page 68 This page intentionally left blank. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 69: Glucose Control Testing

    This is called QC Lockout, and the system actually prevents patient and proficiency testing when the control results are not within the accepted range. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 70: Glucose Control Testing Intervals

    STAT tests can be configured in the meter. This option allows the meter to perform a limited number of blood glucose tests, if circumstances require, despite the meter being in QC Lockout (see page 81). 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 71: Information Stored During Glucose Control Testing

    Level of control solution (L1 or L2) ■ Lot number of the test strips ■ Time and date of test ■ Comments (if applicable) ■ Out of range measurements ■ 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 72: Control Solutions

    (see Chapter 6). The proper test strips must be available. ■ An operator ID must be entered (with password, if ■ applicable), if the meter is configured for login. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 73: Performing Glucose Control Tests

    Patient tests can now be performed (again). 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 74: Starting A Glucose Control Test

    QC Lockout. Touch Level 1 (Lo) or Level 2 (Hi) to select the level for the following test. In the example above, Level 2 (Hi) is marked. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 75: Confirming Or Selecting The Lot Number For Control Solutions

    The meter can be configured so that lot numbers are entered via barcode scanner only. For additional information about storing lot numbers for 03/17/17 control solutions, see page 94. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 76: Confirming Or Selecting The Test Strip Lot

    The meter can be configured so that lot numbers can only be selected from a list. For additional information about storing lot numbers for test strips, see page 87. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 77: Inserting Test Strips

    The meter beeps. The hourglass icon appears and indi- cates that the meter is checking the test strip. Do not apply control solution while it is displayed. 03/17/17 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 78: Applying The Control Solution

    The control solution is pulled into the test strip by capillary action. Once sufficient control solution has been detected, the meter beeps and the measurement begins. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 79: Results Screen

    (Range or Out of … Range). Touch this button to display the minimum and maximum target values for the control levels. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...
  • Page 80 10 minutes of inac- tivity/no screen touches (see “Automatic power-off” on page 22). Remove the test strip and dispose of it in accordance with applicable regulations and directives. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 81: Performing A Stat Test

    If the meter is in a Download Lockout status, and no STAT test is available, the meter can be unlocked by a system administrator (see page 157). 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...
  • Page 82 This page intentionally left blank. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 83: Review Results

    Comments entered at the time the test was per- ■ formed Maintenance results (for documentation of maintenance activities) are stored and displayed with date and time only if comments were added. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 84: List Of Results Stored In The Memory

    From the Main Menu screen touch Review Results. All stored test results are displayed in a sequential list. Touch to scroll up or down in the list. The results are grouped by date. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...
  • Page 85 – If you touch Patient in the Patient Result view (middle screen above), the list of test results for this patient will be displayed. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...
  • Page 86 Touch All in the Glucose Results screen to remove the Patient or QC selection and display all results. Touch to return to the previous menu screen, 03/17/17 or touch to return to the Main Menu. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 87: Storing Test Strip, Control Solution, And Linearity Solution Information In The Meter

    Main Menu 2 do not appear. See also Appendix A. The code key is also frequently referred to as a code chip. The terms are synonymous. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 88: Transferring Code Key Information To The Meter

    The code key reader remains ready to send for a few seconds after it has transmitted data. As a result, you can perform the following procedure on multiple meters without having to reinsert the code key. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...
  • Page 89 I-302: Connecting to code I-303: Receiving code key key reader... contents... Place Meter above the Code Key Reader and then press the Right Arrow button to start. 03/17/17 03/17/17 03/17/17 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...
  • Page 90 Continue entering additional lot numbers, or touch the Right Arrow button to Make 'Current' start. to return to the Main Menu. D-314: Do you want to make Strip lot: 545603 the 'current' lot? 03/17/17 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 91: Editing Test Strip Data

    545603? tinue to the value ranges. Use by: 12/10/17 L1(Lo): 43-74 mg/dL L2(Hi): 288-389 mg/dL 03/17/17 Strip Expiration 12:48 pm 05/30/17 03/17/17 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...
  • Page 92 – Maximum limit value for Level 1 – Minimum limit value for Level 2 – Maximum limit value for Level 2 Touch to confirm each separate entry and continue to the next entry. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...
  • Page 93 03/17/17 Continue entering additional lot numbers, or touch to return to the Main Menu. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 94: Storing Control Solution Information

    Admin. 03/17/17 03/17/17 03/17/17 Touch to open the Main Menu 2 screen. Touch Control Lots to open the related menu. Touch Add to enter a new lot number. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...
  • Page 95 Follow the instructions for scanning IDs (see page 45). Use the keypad to enter the expiration date as stated on the control solution bottle. Touch to confirm the entered expiration date. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...
  • Page 96 03/17/17 touch to store the entries without making the lot number the current lot number. Continue entering additional lot numbers, or touch to return to the Main Menu. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 97: Selecting A Stored Lot Number As The Current Lot Number

    Main Menu to open the Main Menu 2 screen. Touch Control Lots to open the related menu. The current lot number is indicated by an asterisk (*). 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...
  • Page 98 The information Current is then also displayed in the detail view. Touch to return to the list of lot numbers, touch to return to the Main Menu. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 99: Storing Linearity Test Information

    Admin. 03/17/17 03/17/17 03/17/17 Touch to open the Main Menu 2 screen. Touch Linearity Lots to open the related menu. Touch Add to enter a new lot number. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...
  • Page 100 03/17/17 touch to store the entries without making the lot number the current lot number. Continue entering additional lot numbers, touch to return to the Main Menu. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 101: Selecting A Stored Lot Number As The Current Lot Number

    Main Menu to open the Main Menu 2 screen. Touch Linearity Lots to open the related menu. The current lot number is indicated by an asterisk (*). 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...
  • Page 102 The Current information is then also displayed in the detail view. Touch to return to the list of lot numbers, touch to return to the Main Menu. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 103: Linearity Testing

    In this case, the respective buttons in Main Menu 2 do not appear. See also Appendix A. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 104: Linearity Testing Intervals

    Level of linearity solution (L1 to L6) ■ Operator ID (if configured) ■ Lot number of the test strips ■ Time and date of test ■ Comments (if applicable) ■ 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 105: Linearity Test Kit

    (see Chapter 6). The proper test strips must be available. ■ An operator ID must be entered (with password, if ■ applicable), if the meter is configured for login. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 106: Performing A Linearity Test

    03/17/17 03/17/17 03/17/17 Touch in the Main Menu to open the Main Menu 2 screen. Touch Linearity to start the linearity test. The Line- arity Test screen opens. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 107: Confirming Or Selecting The Lot Number For Linearity Test Kits

    03/17/17 barcode scanner to enter the lot number (see page 87). Touch to confirm the selected test strip lot number. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 108: Inserting Test Strips

    The meter beeps. The hourglass icon appears and indi- cates that the meter is checking the test strip. Do not apply linearity solution while it is displayed. 03/17/17 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 109: Applying A Linearity Test Sample

    The linearity solution is pulled into the test strip area by capillary action. Once sufficient linearity solution has been detected, the meter beeps and the measurement begins. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 110: Results Screen

    Test results are saved automatically if the meter is pow- ered off or if it powers itself off after 10 minutes of inac- tivity/no screen touches (see “Automatic power-off” on page 22). 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 111: Proficiency Testing

    In this case, the respective buttons in Main Menu 2 do not appear. See also Appendix A. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 112: Information Stored During Proficiency Testing

    (see Chapter 6). The proper test strips must be available. ■ An operator ID must be entered (with password, if ■ applicable), if the meter is configured for login. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 113: Performing A Proficiency Test

    Review Results Control Lots Linearity Lots Admin. 03/17/17 03/17/17 Touch in the Main Menu to open the Main Menu 2 screen. Touch Proficiency to start the proficiency test. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 114: Entering The Proficiency Sample Id

    Use Strip Lot 123456? barcode scanner to enter the lot number (see page 87). 03/17/17 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 115: Inserting Test Strips

    The meter beeps. The hourglass icon appears and indi- cates that the meter is checking the test strip. Do not apply the proficiency sample while it is displayed. 03/17/17 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 116: Applying A Proficiency Sample

    Do not apply the sample to the top of the strip. The sample is pulled into the test strip area by capillary action. Once sufficient sample has been detected, the meter beeps and the measurement begins. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 117: Results Screen

    (see “Automatic power-off” on page 22). Remove the test strip and dispose of it in accordance with applicable regulations and directives for disposal of potentially infectious samples and materials. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...
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  • Page 119: Initial Startup

    Accu-Chek Inform II system (for ordering information see page 175). Accu-Chek Inform II Base Unit: Accu-Chek Inform II Base Unit Light: 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...
  • Page 120 PC with the USB cable. For connecting the Base Unit with older hardware (REF 05060290001), see Appendix F, “Appendix for Accu-Chek Inform II Base Unit (legacy version)”. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 121: Installing Or Replacing The Battery Pack

    Replace the battery pack only in shutdown mode, see page 122. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 122: Removing The Battery Pack

    If you press the On/Off button for too long, a meter reset will be triggered after about 12 seconds (see section “Meter reset” on page 168.) Place the meter face down on a level surface. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...
  • Page 123 Do not dispose of the batteries with normal domestic waste. Dispose of used batteries in accordance with applicable local regulations and directives and your facility’s guidelines on the disposal of electronic waste equipment. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 124: Installing The Battery Pack

    To position the battery pack correctly, always align the ridges on the side of the battery pack with the ridges on the inside of the battery compartment. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...
  • Page 125 03/17/17 tests. After installing a new battery pack, the meter should be AM/PM charged for at least 8 hours (e.g., overnight) in the base unit before testing. 03/17/17 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 126: Docking The Meter

    This display is visible when communication is still active Docked 12:48 pm but the meter is busy processing the data received or waiting for the next data message from the Data Management System (DMS). Busy... 03/17/17 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...
  • Page 127 Main Menu view after a test). If a meter is in standby (but not docked) and commu- ■ nicating wirelessly, this communication is not visible on the display. The display remains blank. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 128: Initial Setup On The Meter

    The option Service Menu (see section 10.7) with the feature “Delete Patient Information” is not available in the preconfigured default setting. The Service Menu can only be activated via DMS. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 129: Menu Overview

    – Enter Control Lot Expiration Date – Select Control Result(s). Review Results Review Glucose Test – Review All Test Results Review Other Test – Review All OTE Results 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...
  • Page 130 Diagnostics – List Software Versions – Test Barcode Scanner – Meter Events Log – Statistics – Configuration – Ranges – Wireless Setup – Wireless Status – Wireless Test 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...
  • Page 131 Service Menu Delete Patient Information – Delete all patient-related data (patient list and results) Touch to confirm and save any changes to the settings. Only if activated via DMS 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 132: Opening The Setup Menu

    Touch Admin. to open the Admin Menu. Touch Setup Menu to open the Setup Menu. Enter the Setup password if requested (see “Creating a setup password” on page 142). 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 133: Date And Time Format

    – dd.mm.yy: The date is displayed in two-digit day/ month/year format Touch to save the settings, touch to exit this menu without saving any changes. The display returns in both cases to the Setup Menu. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 134: Display Options And Optional Tests

    The display returns in both cases to the Setup Menu (after entering the number of STAT tests allowed). 03/17/17 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 135: Options For Test Strips

    – Scan only: Lot numbers can be verified via barcode scanner only. Touch to change to the second screen of options, touch to exit this menu without saving any changes. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...
  • Page 136 – Lot entry: The operator must enter the lot number. Touch to save the settings (for both settings screens), touch to return to the first settings screen. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 137: Options For Glucose Control Tests

    QC Strips 12:48 pm the specified number of tests. When a glucose con- trol test is run successfully, the test strip counter is reset to “0”. 03/17/17 03/17/17 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...
  • Page 138 If the Hours or Strip Count option is enabled, enter the desired number, touch to exit this menu without saving any changes. The display returns in both cases to the Setup Menu. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 139: Value Ranges (Normal, Critical, Reportable)

    Use the keypad to enter the first value. Touch to enter the following value, touch to return to the previous view. After entering the last value, touch to save all the previous settings. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 140: 9.11 Options For Operator Id Entry

    If the Length option is enabled, enter the desired numbers, touch to exit this menu without saving any 03/17/17 changes. The display returns in both cases to the Setup Menu. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 141: 9.12 Patient Id Options

    The display always returns to the Setup Menu (after entering the desired numbers). 03/17/17 03/17/17 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 142: 9.13 Creating A Setup Password

    To disable password protection: Open the Setup Menu (you must enter the current password). 03/17/17 Touch Password. Delete the current password by touching Touch to disable password protection. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 143: 9.14 Setting The Date And Time

    Enter the date first, then time (all values are two- digit with a leading zero, if necessary) by touching If the time format is “12h”, touch am/pm to select the correct time. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 144: 9.15 Beeper Options

    Touch the button with the desired volume. When you touch a button, the meter will beep at the corresponding volume. Touch to save the setting and return to the Main Menu 2 screen. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 145: 10 Maintenance And Care

    – Leaving the meter under a bilirubin light or photo therapy light – Leaving the meter on a bed warmer – Leaving the meter in an isolette See Chapter 12 for operating and storage temperature ranges. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 146: Shipping

    For short distances - example between a facility’s sites - users may transport the battery packs (either installed in the meter or separately) by road without having to meet further requirements. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 147: Storage

    (HICPAC), William A. Rutala, Ph.D., M.P.H., and David J. Weber, M.D., M.P.H. Centers for Disease Control and Prevention, 2008. Guideline for Disinfection and Sterilization in Healthcare Facilities. Atlanta, GA. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 148: Guide To Cleaning And Disinfecting The Accu-Chek Inform Ii System

    (HICPAC), William A. Rutala, Ph.D., M.P.H., and David J. Weber, M.D., M.P.H. Centers for Disease Control and Prevention, 2008. Guideline for Disinfection and Sterilization in Healthcare Facilities. Atlanta, GA. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 149: Acceptable Cleaning/Disinfecting Agents

    NOTE: Roche has tested the approved cleaning and dis- infecting product for a total of 12,045 cycles, which is equal to cleaning and disinfecting after each patient use simulating 3 years of device use. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 150: What To Clean/Disinfect

    ■ on/off button button malfunction ■ clouding of the infrared data port and/or barcode ■ scanner quality control results outside of the specified ■ range 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 151: 10.3 How To Clean And Disinfect The Accu-Chek Inform Ii System

    If solution is allowed to collect in any meter opening, severe damage to the system can occur. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 152: Cleaning The Meter

    Ensure that the meter is thoroughly dried after cleaning (see safety message “Avoid getting liquid into the test strip port!” and NOTICE in this section). 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 153: Disinfecting The Meter

    NOTICE in this section). If further testing is not needed, return the meter to the base unit to charge the battery. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 154: 10.4 Logging Maintenance Activities

    Test screen opens up. Touch to return to Main Menu 2. You can add up to three comments. For details see 03/17/17 section “Adding comments” on page 65. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 155: 10.5 Diagnostics View

    Scan: Admin. 03/17/17 03/17/17 03/17/17 Touch in the Main Menu to open the Main Menu 2 screen. Touch Diagnostics to call up the main screen for this menu. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...
  • Page 156 Completed: 03/17/17 03/17/17 Touch to scroll between screens. Touch Log to display stored error messages. Touch to test the barcode scanner. Touch to return to the Main Menu. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 157: 10.6 Unlocking A Download Lockout

    Since unlocking is a function of the Setup Menu, it is restricted to persons who know the setup password. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...
  • Page 158 Touch Setup Menu to open the Setup Menu. Enter the Setup password if requested. Touch Unlock to reset the lockout timer. The meter shuts down, and is ready for testing after powering up again. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 159: 10.7 Service Menu

    Therefore, always ensure that you have downloaded all relevant patient results before you use this function. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...
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  • Page 161: 11 Troubleshooting

    Follow the instructions in Chapter 9 to avoid data loss when replacing the battery pack. Meter displays an unexpected result Refer to the package insert for the test strips. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...
  • Page 162 – Check that you are performing the test correctly (see Chapter 4). – Repeat the glucose control test with a new test strip. – If the error persists, contact Accu-Chek Customer Care. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...
  • Page 163 – Check the configuration and/or the connection to the Data Management System (DMS). Contact the DMS or IT administrator of your institution. – If the error persists, contact Accu-Chek Customer Care. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...
  • Page 164 – Check that the battery pack is correctly installed and connected. – Replace the defective battery pack. Follow the instructions in Chapter 9 to avoid data loss when replacing the battery pack. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 165: Low Power Icons

    – Redock it by gently pushing it into the base unit to ensure proper contact. Once the meter is properly docked and charging, the battery charging icon stops flashing. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 166: Pop-Up Messages

    12:48 pm Patient 123456789 Date 03/17/17 12:48 pm Range I-502: Normal Range: 70-200 mg/dL – I: Information; touch to confirm. Critical Range: 40-301 mg/dL Reportable Range: 11-600 mg/dL 03/17/17 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...
  • Page 167 – E: Error; touch to confirm. To resolve the problem, E-314: Invalid Scan. The scan returned an entry > take the actions suggested. 20 characters. Please see your System Administrator. 03/17/17 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 168: Meter Reset

    W-1302: D/T settings lost due to meter reset or loss of power. Before performing further tests: Enter D/T manually and synchronize meter. OR: Ask System Admin. for help. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...
  • Page 169 12:48 pm tests. Even if your configuration does not require it, we recommend always performing a QC test after a meter AM/PM reset. 03/17/17 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...
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  • Page 171: 12 General Product Information

    – 5,000 Operator ID records – 4,000 Patient ID records – 300 Predefined comments – 20 Code Files (test strip lots) – 100 Reagent Lots (control, linearity, OTE) – 250 Events 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...
  • Page 172 (Remove battery pack from meter for long-term storage.) Humidity (operating) 10 - 90 % RH (non-condensing) Air pressure 0.7 to 1.06 bar 0.7 to 1.06 bar 70 to 106 kPa 70 to 106 kPa 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...
  • Page 173 * Not applicable to Accu-Chek Inform II Base Unit Light ** EAN 13 barcodes are not recommended for identification of operators and patients 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...
  • Page 174 0.6 μL The performance of this system has not been evaluated in the critically ill. For more information about the Accu-Chek Inform II test strip, refer to the package insert for instructions for use, performance characteristics, and limitations of the system.

  • Page 175: 12.2 Further Information

    Power supply for Base Unit REF 07671717190 07455976190 (North America) Accu-Chek Inform II Base Unit Wall Mount for Base Unit (fits old and new 05404878001 Wall Mount versions)/Base Unit Light 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...
  • Page 176 UU14000000) Accu-Chek Inform II RF Card Kit Wi-Fi card replacement (accessory, for meters 05112699001 with older hardware and serial no. below UU14000000) 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 177: Accu-Chek Inform Ii Operator's Manual And Quick Reference Guide

    Supplies are available through Roche Diagnostics. Contact Accu-Chek Customer Care. Product Limitations Read the information in the package insert supplied with the reagents and solutions for detailed product data and limitations. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 178: Information About Software Licenses

    “ROCHE BU Technical Note UDS5”. You can access these files by connecting the Accu-Chek Inform II Base Unit to a PC with the USB cable. For detailed instructions on how to do this, see the instruction sheet “Setting Up the Base Unit” included in the Accu-Chek Inform II Base Unit Kit.

  • Page 179: Contact Roche

    “Worldwide” to find the appropriate local office contact information. The Accu-Chek Inform II system is manufactured for and distributed by: In the United States: Roche Diagnostics 9115 Hague Road Indianapolis, IN 46256 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...
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  • Page 181: A Appendix

    30 – 3,600 s automatically if no activity)* * Not applicable in measurement mode (see “Automatic power-off” on page 22). Beeper Beeper volume 0: low 1: medium 2: high 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...
  • Page 182 Reportable range HI limit 10 – 600 mg/dL 600 mg/dL 0.6 – 33.3 mmol/L 33.3 mmol/L Reportable range LO limit 10 – 600 mg/dL 10mg/dL 0.6 – 33.3 mmol/L 0.6 mmol/L 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...
  • Page 183 7: Swedish 8: English (USA) 9: Danish 11: Portuguese Glucose result units 0: mg/dL 1: mmol/L * Other languages: For the availability of languages not listed above, contact Roche. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...
  • Page 184 Admin menu “Setup” (if enabled, access to 0: disabled setup screens is possible) 1: enable Setup password 0 – 20 characters “” Reagent editing allowed 1: Allowed 2: Password needed 0: Not allowed 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...
  • Page 185 Patient ID barcode mask (see separate 0 – 300 characters* “” table at the end of this chapter) * The number of characters in the unmasked barcode may not exceed 20. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...
  • Page 186 Patient ID minimum length (used to vali- 0-20 date a patient ID if patient ID validation mode is set to “Length” or “List - allowed to add new”) Patient name length 0-25 characters 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...
  • Page 187 6 POCT1-A data fields 06:00 00:00 – 23:59 09:00 12:00 15:00 18:00 22:00 QC time of day set 6 POCT1-A data fields 1 0 0 0 0 0 0 or 1 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...
  • Page 188 DNS IP (IP address of the DNS-server if 0.0.0.0 – 255.255.255.255 0.0.0.0 DHCP is not used and DNS is configured) Gate IP (static gateway IP address) 0.0.0.0 – 255.255.255.255 0.0.0.0 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...
  • Page 189 0: Passphrase 1: Key WPA Key string of 64 characters “” (HEX) WPA pass phrase (Un-encrypted text used 8 – 63 characters “” to generate the 256-bit preshared key.) 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...
  • Page 190 1: enabled PDF417 0: disabled 1: enabled Aztec 0: disabled 1: enabled PreAimer Delay (in milliseconds) 0 - 9,999 Interleaved 2 of 5 0: disabled checksum validation 1: enabled 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...
  • Page 191 2 - WPA_PSK 3 - AES/TKIP 0 - passphrase - 8-63 characters (WPA2/WPA) 2 - WPA_PSK 3 - AES/TKIP 1 - key 64 charac- (WPA2/WPA) ters HEX 4 - EAP 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...
  • Page 192 ID. If the scan data character is not equal to the mask character following the “^”, the barcode reading is invalid as an ID. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 193: Example Of Barcode Symbologies

    If no operator/patient list can be used, it is recommended that you at least set a minimum length for the respective ID, even if your facility uses IDs of varying length. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...
  • Page 194 For questions about working with barcodes that are not answered in this manual and for best practice guidelines on creating and reading barcodes, contact Accu-Chek Customer Care (see Chapter 12). 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...
  • Page 195 Ensure that your printer can print the module width of the barcode with the required resolution, i.e., that there is no mismatch between print resolution and module width. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...
  • Page 196 GS1 DataBar Limited Interleaved 2/5 Interleaved 2/5 without checksum with checksum PDF417 Aztec Roche Professional Diagnostics Roche Professional Diagnostics DataMatrix QR Code Roche Professional Diagnostics Roche Professional Diagnostics 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 197: B Appendix

    Access Point(s) that are connected to the (wired) Local Area Network and one or more clients, e.g., Accu-Chek Inform II meters along with other clients such as portable computers. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 198: Technical Implementation

    Prior to changing or upgrading the facility wireless network infrastructure, contact Accu-Chek Customer Care for technical assessment and assistance. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...
  • Page 199 USA. (Channels 12-14 are not used by the Accu-Chek Inform II meter.) RF output power is approximately 15 dBm at a data ■ rate of 54 MBPS. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 200: Rf Specific Functionalities And Effective Performance Claims

    As described above, the Accu-Chek Inform II meter supports the 802.11g standard. This translates into the following RF specific performance claims: 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...
  • Page 201 . If the meter is left to power off automatically (see page 22) or powered off manually using the On/Off button the result will be transmitted only after another 10 minutes in the next communication cycle. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...
  • Page 202 DMS. Users should be aware that real- time communication of blood glucose readings cannot be guaranteed by the Accu-Chek Inform II meter. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 203: C Supplement For Other Test Entry

    Test/Other Control Tests) each time. The examples in this manual are for illustration purposes only. Consult the instructions that come with the DMS for details and configuration options. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 204: Overview Of Other Test Entry (Ote)

    The Other Test Entry feature also allows you to add information about prescribed insulin type and number of units: Rapid-Acting Insulin ■ Regular Insulin ■ Intermediate-Acting Insulin ■ Long-Acting Insulin ■ Insulin Mixtures ■ 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...
  • Page 205 Fecal Occult (F Occ) ■ Gastric Occult (G Occ) ■ Ketones (Ket) ■ Rapid-Acting (Rap-I) ■ Regular (Reg-I) ■ Intermediate-Acting (Int-I) ■ Long-Acting (Long-I) ■ Insulin Mixtures (Mix-I) ■ 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...
  • Page 206 Enter the onboard control result(s) if available. ■ Enter the test result(s). ■ Select appropriate comments. ■ Note: The display of date of birth (DOB) is not available for OTE workflows. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 207: Recording Other Patient Tests

    Rapid DAT 03/17/17 03/17/17 03/17/17 From the Main Menu screen touch Patient Test. From the Patient Test Menu touch Other Test. The Other Patient Tests menu list is displayed. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...
  • Page 208 Select the desired test from the display list. If you need to change an entry, touch to return to the previous screen. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...
  • Page 209 For single digit numbers, add a leading zero. Touch to proceed to the next screen. See also section “Entering or selecting the patient ID” in Chapter 3. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...
  • Page 210 Use the keypad to enter the Fecal Card Lot expira- tion date. Touch to proceed to the next screen. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...
  • Page 211 Use the keypad to enter the Fecal Developer Lot expiration date. Touch to proceed to the next screen. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...
  • Page 212 Select the result of the Negative Control as accept- able or not acceptable by touching the appropriate button. Select the patient test result as positive or negative by touching the appropriate button. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...
  • Page 213 Main Menu. Test results are also saved when the meter is powered off in the results screen or automatically powers off. See also section “Adding comments” in Chapter 3. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 214: Recording Other Control Tests

    Operator ID ■ Type of control ■ Date tested ■ Time tested ■ Kit lot number ■ Control lot number ■ Control test result(s) ■ Comment (if applicable) ■ 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...
  • Page 215 The control solution results must fall into the acceptable range indicated on the test kit or reagent packaging, or as defined by your institution, before being considered successful. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...
  • Page 216 Rapid DAT 03/17/17 03/17/17 Select the desired test from the display list. (Pregnancy control will be used as the example.) Select the type (level) of control being used. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...
  • Page 217 Use the keypad to enter the time the test was performed. For single digit numbers, add a leading zero. Touch to proceed to the next screen. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...
  • Page 218 Pregnancy Kit Lot number. Touch to proceed to the next screen. Use the keypad to enter the Pregnancy Kit Lot expiration date. Touch to proceed to the next screen. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...
  • Page 219 (Ctrl Result) as acceptable or not acceptable by touching the appropriate button. Once the results are entered, the Pregnancy Control result screen is displayed. To change an entry or a result, touch the appropriate button. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 220: Warning Messages

    If the result is entered as not acceptable, subse- quent patient results may not be valid due to the invalid control bar result. See also section “Adding comments” in Chapter 3. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 221: Reviewing Other Test Results

    From the Main Menu screen touch Review Results. From the Test Result Menu touch Review Other Test. All stored OTE test results are displayed in a sequential list. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...
  • Page 222 The results are grouped by date. Touch an entry in the list to display the related details. Touch to display all available pages of a test result. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...
  • Page 223 Touch All in the Other Test Results screen to remove the Patient or QC selection and display all results. Touch to return to the previous menu screen, touch to return to the Main Menu. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 224: 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 administrator. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 225: D Supplement For Observed Test Sequence

    The contents of the message is OTS training before you can use the meter. created on the DMS and may vary. The screen message shown here is for illustration purposes only. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 226: Using The Ots Function

    12:48 pm Test button is now available. Observer Login Hand the meter to the operator who can now perform the patient test under supervision. Glucose Test Other Test 03/17/17 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...
  • Page 227 Pass or Fail. Touch , if you want to add a comment. Touch to return to the Main Menu screen. The OTS information is saved together with the test result. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...
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  • Page 229: E Supplement For Enhanced Workflows

    See Appendix A.1, “Table of configuration options”. The activation of these features is only possible via a suitable data management System (DMS). 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 230: Blood Sample Type Selection

    Capillary Use Strip Lot Arterial 123456? Venous Heel Stick 03/17/17 03/17/17 Patient ID 12:48 pm Patient Test 12:48 pm Sample Type: Capillary Arterial Venous Heel Stick 03/17/17 03/17/17 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...
  • Page 231 Slide the test strip into the test strip port as far as it goes in the direction indicated by the arrows on the test strip. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 232: Isolation Room Workflow

    Once a test strip has been removed from the vial, the blood sample must be applied within 3 minutes. Take the meter and the test strip to the isolation room. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...
  • Page 233 However, where this is not possible due to an altered workflow (example: Isolation Room Workflow), studies show that the test strips remain stable for 3 minutes between removing them from the vial and applying a blood sample. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...
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  • Page 235: F Appendix For Accu-Chek Inform Ii Base Unit (Legacy Version)

    – Lights up red: Power supply is connected, applica- tion is starting up – Lights up green: Ready – Flashes red: Error – Lights up blue: Configuration mode 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...
  • Page 236 Removable mount for wall installation Network connection — Ethernet/RJ45 port USB port Jack for the power supply unit 7.5V 1.7A provided USB configuration switch (for System Administrator use only) 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 237: Connecting The Base Unit (Legacy Version)

    Accu-Chek Inform II system. Slide the base unit back onto the wall mount (if in use). For details on configuring the Accu-Chek Inform II Base Unit, contact Accu-Chek Customer Care. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 238: Technical Data

    DC connector IR port Replaceable AC input contacts RJ45 Ethernet USB type B Data transfer rate IR: 9.6K - 115K bps Ethernet: 10 Mbps half-duplex USB: 12 Mbps 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...

  • Page 239: G Limited Warranty

    This warranty gives you specific legal rights, which vary from state to state. 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...
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  • Page 241: Index

    Information service ..........179 Editing control lot data ......94–98 Selecting .............75 Initial startup ..........120–156 Storing information ......87–102 Isolation Room Workflow ........232 License (GPL) ............178 Linearity lots 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...
  • Page 242 Other Test Entry (OTE) ......203–223 Protection against infection ....... 20 User qualification ........... 20 Safety information ........... 21–29 Sample Applying ........61, 78, 109, 116 Select type ............230 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...
  • Page 243 WLAN security ............191 Overview (accessory box) ......39 Overview (base unit hub) ......38 Overview (base unit) ........36 Overview (code key reader) ......35 Overview (meter) ..........33 Technical data ........171, 238 Troubleshooting ........161–169 08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6...
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  • Page 245 Notes...
  • Page 246 Notes...
  • Page 248 ACCU-CHEK, ACCU-CHEK INFORM, and COBAS are trademarks of Roche. Roche Diagnostics GmbH Sandhofer Strasse 116 68305 Mannheim, Germany Manufactured for and distributed in the U.S.A. by: Roche Diagnostics 9115 Hague Road Indianapolis, IN 46256 Rx only https://usdiagnostics.roche.com...

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