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

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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...
  • Page 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. editorial revisions...
  • Page 3 CCU- CCU- Inform II System ® Operator’s Manual Version 4.0 0 4807839001 (04) 2012-11 EN...
  • Page 4 Please send questions or comments about this manual to your local Roche representative. ACCU-CHEK, ACCU-CHEK INFORM, ACCU-CHEK PERFORMA and COBAS are trademarks of Roche. All other trademarks are the property of their respective owners. The Wi-Fi CERTIFIED Logo is a certification mark of the Wi-Fi Alliance.

  • Page 5: Table Of Contents

    Introduction 1.1 Before you start............................11 Intended use ............................11 Important information regarding use ..................11 If you need help ..........................12 Note on the use of “base unit” in this manual..............12 Note on illustrations in this manual ..................12 What can the system do for you? ....................
  • Page 6 Patient Glucose Testing 3.1 Information regarding blood glucose testing ................39 Preparing to test ..........................39 3.2 Performing a patient glucose test...................... 40 Overview of test procedure ......................40 Entering or selecting the patient ID ..................40 Entering the patient ID manually....................42 Selecting the patient ID from a list....................
  • Page 7 Linearity Testing 7.1 Information regarding linearity tests....................83 Linearity testing intervals ......................83 Information stored during linearity testing................84 Linearity test kit ..........................84 Preparing to run a linearity test ....................84 7.2 Performing a linearity test........................85 Overview of test procedure ......................85 Starting a linearity test ........................
  • Page 8 Meter reset ............................141 General Product Information 12.1 Technical data ............................143 12.2 Further Information..........................145 Ordering ............................145 Accu-Chek Inform II Operator’s Manual and Quick Reference Guide..... 146 Reagents and Solutions ......................146 Information about software licenses..................147 Contact Roche..........................147 Appendix A.1 Table of configuration options ......................
  • Page 9 Supplement for Other Test Entry C.1 Before you start............................165 Description ............................165 C.2 Overview of Other Test Entry (OTE) ....................166 Introduction ............................. 166 C.3 Recording Other Patient Tests ......................169 C.4 Recording Other Control Tests ......................176 Introduction ............................. 176 Other Control Testing Intervals....................
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  • Page 11: Introduction

    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 system is indicated for use by healthcare professionals.

  • Page 12: If You Need Help

    (see Chapter 12). In order to expedite troubleshooting, please have ready your Accu-Chek Inform II meter, its serial number, this manual, and all related consumables when you call. If you suspect a com- munication error beyond the meter, also have your Accu-Chek Inform II Base Unit serial number ready to help assist our customer care group in troubleshooting.

  • Page 13: What Can The System Do For You

    Introduction • 1 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- ■...

  • Page 14: Important Safety Instructions And Additional Information

    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 symbol alone (without a signal word) pro- motes awareness to hazards which are generic or directs the reader to related safety information.

  • Page 15: Important Information Regarding Safety

    Operators need to adhere to Standard Precautions when handling or using the Accu-Chek Inform II system. All parts of this system should be considered potentially infectious and are capable of transmitting blood-borne pathogens between patients and healthcare professionals.

  • Page 16: Disposal Of The System

    ■ locally. Disposal of the system Infection by a potentially biohazardous instrument The Accu-Chek Inform II system or its components must WARNING be treated as potentially biohazardous waste. Decontam- ination (i.e., a combination of processes including clean- ing, disinfection and/or sterilization) is required before reuse, recycling, or disposal.

  • Page 17: Product Safety

    Introduction • 1 Product safety Observe the following information to ensure product safety: The system is suitable for continuous operation. ■ NOTICE The system is not protected against the harmful ingress of fluids (IP X0 rating according to IEC 60529). General care NOTICE Clean the system only with the solutions recommended.

  • Page 18: Battery Pack

    Observe the following general safety instructions for handling batteries: Do not dispose of the battery pack with normal domestic waste. As a component of the Accu-Chek Inform II system, it must be deemed as potentially biohazardous. Treat it accordingly. See “Disposal of the system” on page 16.

  • Page 19: Touchscreen

    WARNING laser beam. Electrostatic discharge (ESD) The Accu-Chek Inform II system complies with both the electromagnetic immunity requirements and radio inter- ference immunity requirements at the frequency and test levels according to EN ISO 15197 Annex A. The system also...

  • Page 20: Local Area Network: Protection From Unauthorized Access

    Wired network connection If connected to a local area network, the Accu-Chek Inform II Base Unit or Accu-Chek Inform II Base Unit Hub must be protected against unauthorized access by means of a strong password management that applies the...

  • Page 21: Wireless Network Connection (Rf Card)

    For information about how to temporarily enable or disable this function, see page 35. For a description of the Accu-Chek Inform II meter’s ability to connect to Wireless Local Area Net- works (WLAN, Wi-Fi), see appendix B.

  • Page 22: Radiofrequency Radiation Exposure Information

    Note: The following table provides an overview of the classifications for electromagnetic compliance (EMC, according to CISPR 11) for different combinations of Accu-Chek Inform II system components. Refer to the explanatory texts following the table for more infor- mation on these classifications.
  • Page 23 The Accu-Chek Inform II system complies with FCC radi- ation exposure limits set forth for an uncontrolled envi- ronment. This equipment should be installed and operated with minimum distance of 20 cm (8 inches) between the radiator and your body.
  • Page 24 (1) this device may not cause harmful interference, (2) this device must accept any interference received, including interference that may cause undesired operation. 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 B.

  • Page 25: Note On Systems With Older Hardware

    PC via a cable. Note: The following classification applies if an Accu-Chek Inform II meter (with RF card) with a serial number below UU11030000 is docked in an Accu-Chek Inform II Base Unit with a serial number...
  • Page 26 1 • Introduction 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 the interference.

  • Page 27: System Components

    Introduction • 1 System components The Accu-Chek Inform II system includes the following components and accessories: Meter Code key reader Base unit with power supply Accessory box (shown with consumables, not included) The system can be configured by two different methods:...

  • Page 28: Overview Of The Meter

    1 • Introduction Overview of the meter The meter has the following elements: Test strip port Insert the test strip here. 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, simply touch the button on the screen.

  • Page 29: Overview Of The Code Key Reader

    Introduction • 1 Overview of the code key reader Test strip vials include a code key. 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.

  • Page 30: Overview Of The Base Unit

    The Accu-Chek Inform II Base Unit Light ■ Both versions of the base unit can: charge the meter battery pack. ■ In addition, the Accu-Chek Inform II Base Unit also supports: communication with a data management system. ■ communication with a computer.

  • Page 31: Overview Of The Accessory Box

    Accu-Chek Inform II Test Strips ■ Accu-Chek Performa Control Solutions ■ Accu-Chek Linearity Kit (if required by your facility ■ guidelines) Your facility provides additional consumables such as blood collection supplies. Observe the current rules and safety guidelines for collecting and handling blood samples.

  • Page 32: Instructions For Initial Setup

    1 • Introduction 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 ■...

  • Page 33: Powering Up And Entering An Operator Id

    Powering Up and Entering an Operator ID • 2 Powering Up and Entering an Operator ID Powering up the meter Press and release the On/Off button . The meter is now on. The Power Up screen appears. Check in the Power Up screen whether the date (lower left) and time (upper right) are displayed correctly.

  • Page 34: Adjusting The Display

    2 • Powering Up and Entering an Operator ID 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 ■...

  • Page 35: Enabling/Disabling The Rf Card

    WARNING reassess the appropriateness of continued use of the WLAN functionality of the Accu-Chek Inform II system using the guidelines of your facility. If the RF card is activated, the (RF OFF) icon is dis-...

  • Page 36: Closing Startup

    2 • Powering Up and Entering an Operator ID 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- ■...

  • Page 37: Entering An Operator Id With Barcode Scanner

    Powering Up and Entering an Operator ID • 2 Entering an operator ID with When the screen for entering the operator ID is barcode scanner displayed: Operator ID 12:48 11/19/12 Press and release . The button now appears with a black background (during the scan). Hold the meter so that the window of the barcode scanner is approx.

  • Page 38: Entering The Operator Id Manually

    2 • Powering Up and Entering an Operator ID Entering the operator ID When the screen for entering the operator ID is manually displayed: Operator ID 12:48 Operator ID 12:48 Operator ID 12:48 MARIA MARIA S. 11/19/12 11/19/12 11/19/12 Touch the letters or numbers to enter the ID. Use the following buttons to toggle between ranges of characters: –...

  • Page 39: Patient Glucose Testing

    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. ■ Power Up 12:48 The code file for the test strip lot in use must be ■...

  • Page 40: Performing A Patient Glucose Test

    3 • Patient Glucose Testing 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 ■...
  • Page 41 Patient Glucose Testing • 3 You now have three different options, depending on setup, for assigning the subsequent test to a patient. The patient ID function can be configured by your system administrator to: Enter any combination of up to 20 alphanumeric ■...

  • Page 42: Entering The Patient Id Manually

    3 • Patient Glucose Testing 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. Touch the letters or numbers to enter the ID. Patient ID 12:48 Use the following buttons to toggle between ranges...

  • Page 43: Selecting The Patient Id From A List

    Patient Glucose Testing • 3 Selecting the patient ID from a Choose the patient ID from a list*, if a list has been down- list loaded to the meter (from the data management system). Touch to scroll up or down in the list. Patient ID 12:48 If one of the buttons is hidden, you have reached the top...

  • Page 44: Entering A Patient Id With Barcode Scanner

    3 • Patient Glucose Testing Entering a patient ID with When the screen for entering the patient ID is displayed: barcode scanner Patient ID 12:48 Patient ID 12:48 Keyboard Name: James Doe ID: 2222222222 Name: Jane Doe ID: 3333333333 Name: Jenny Doe ID: 4444444444 Name: John Doe 11/19/12...

  • Page 45: Confirming Or Selecting The Test Strip Lot

    Patient Glucose Testing • 3 Confirming or selecting the test Once you have entered and confirmed the patient ID, you strip lot 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.

  • Page 46: Inserting Test Strips

    Remove the test strip from the test strip vial and close the vial with the cap. Hold the test strip so the lettering “ACCU-CHEK” is facing upward. 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.

  • Page 47: Applying A Blood Sample

    Patient Glucose Testing • 3 Applying a blood sample Once the meter has detected the test strip, you are prompted to apply a blood sample. Patient Test 12:48 Patient 123456789 Strip Lot 545794 11/19/12 When applying the sample, position the meter so that the test strip port is always higher or on the same level as the blood drop.

  • Page 48: Results Screen

    3 • Patient Glucose Testing Results screen The hourglass icon indicates the test is running. When the test is completed and the result is ready, the meter beeps again. Patient Test 12:48 Patient Test 12:48 Patient Test 12:48 Patient 123456789 Patient 123456789 Patient 123456789 Strip Lot 545794...
  • Page 49 (strips and meter) and is the only range which cannot be con- figured. With Accu-Chek Inform II test strips this fixed range is 10 to 600 mg/dL (0.6 to 33.3 mmol/L). If a result falls outside this range, the message HI or LO appears, i.e.
  • Page 50 3 • Patient Glucose Testing 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 threshold, but ■...

  • Page 51: Adding Comments

    Patient Glucose Testing • 3 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. Of these three comments only one can be a custom comment;...
  • Page 52 3 • Patient Glucose Testing Test results are also saved when the meter is powered off in the results screen or automatically powers off after 10 minutes of inactivity (no screen touches). See “Automatic power-off” on page 17. Remove the test strip and dispose of it in accordance with applicable regulations and directives for disposal of potentially infectious samples and materials.

  • Page 53: Glucose Control Testing

    Glucose Control Testing • 4 Glucose Control Testing 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 other working solutions” on page 16.

  • Page 54: Glucose Control Testing Intervals

    4 • Glucose Control Testing 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 a new test strip lot), a warning is displayed when the meter is switched on and when the Glucose Test function is selected.

  • Page 55: Information Stored During Glucose Control Testing

    Glucose Control Testing • 4 Information stored during The following information is stored for every glucose con- glucose control testing trol test using control solution: Glucose control test result ■ Lot number of the control solution ■ Operator ID (if configured) ■...

  • Page 56: Performing Glucose Control Tests

    4 • Glucose Control Testing 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. ■...

  • Page 57: Starting A Glucose Control Test

    Glucose Control Testing • 4 Starting a glucose control test After preparing the meter as described, you can proceed to the steps directly related to control testing: Main Menu 12:48 Control Test 12:48 Patient Test Level 1 (Lo) Control Test Level 2 (Hi) Required Review Results...

  • Page 58: Confirming Or Selecting The Lot Number For Control Solutions

    4 • Glucose Control Testing Confirming or selecting the lot Once you have selected the level, you are asked to con- number for control solutions 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.

  • Page 59: Confirming Or Selecting The Test Strip Lot

    Glucose Control Testing • 4 Confirming or selecting the test Once you have entered and confirmed the lot number of strip lot 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 vial.

  • Page 60: Inserting Test Strips

    Remove the test strip from the test strip vial and close the vial with the cap. Hold the test strip so the lettering “ACCU-CHEK” is facing upward. 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.

  • Page 61: Applying The Control Solution

    Glucose Control Testing • 4 Applying the control solution Once the meter has detected the test strip, you are prompted to apply the control solution. Control Test 12:48 Control L2 (Hi) 123456 Strip Lot 545794 11/19/12 Wait until the flashing drop appears in the display before applying the control solution.

  • Page 62: Results Screen

    4 • Glucose Control Testing Results screen The hourglass icon indicates the test is running. When the test is completed and the result is ready, the meter beeps again. Control Test 12:48 Control Test 12:48 Control Test 12:48 Control L2 (Hi) 123456 Control L2 (Hi) 123456 Control L2 (Hi) 123456 Date 11/19/12 12:48...

  • Page 63: Performing A Stat Test

    Glucose Control Testing • 4 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.
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  • Page 65: Review Results

    Review Results • 5 Review Results Displaying test results from the memory Information stored in data When you retrieve the data record for stored test results, records for test results the following information is displayed. Patient ID, glucose control, or sample ID ■...
  • Page 66 5 • Review Results Glucose Results 12:48 Patient Result 12:48 Glucose Results 12:48 All -- 06/19/12 -- mmol/L ID: 123456789ABCDEFG ID: 123456789ABCDEFG Name: Joe M. Doe Time Rslt Patient -- 06/18/12 -- mmol/L 7:15 4.1 123456789ABC Time Rslt Strip Lot: 400433 5:32 12.7 123456789ABC 7:15...

  • Page 67: Storing Test Strip, Control Solution, And Linearity Solution Information In The Meter

    Storing Test Strip, Control Solution, and Linearity Solution Information in the Meter • 6 Storing Test Strip, Control Solution, and Linearity Solution Information in the Meter Storing information about test strips Each box of test strips contains a code key. Each code key belongs to a single lot number and provides impor- tant information about the lot-specific properties of the...

  • Page 68: Transferring Code Key Information To The Meter

    6 • Storing Test Strip, Control Solution, and Linearity Solution Information in the Meter Transferring code key The following description assumes that the meter is pow- information to the meter ered on and the Main Menu is displayed. Main Menu 12:48 Main Menu 2 12:48...
  • Page 69 Storing Test Strip, Control Solution, and Linearity Solution Information in the Meter • 6 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.

  • Page 70: Editing Test Strip Data

    6 • Storing Test Strip, Control Solution, and Linearity Solution Information in the Meter Information about the expiration date and parameters for Add Strip Lot 12:48 control solutions is subsequently displayed. Strip Lot Confi rmation Touch to store the data for this lot number in D-530: Do you want to the meter without changes, or use the suggested...
  • Page 71 Storing Test Strip, Control Solution, and Linearity Solution Information in the Meter • 6 The parameters for control solutions consist of four sepa- rate values. Strip Expiration 12:48 Control L2 Min 12:48 Control L2 Max 12:48 11/30/12 mmol/L 21.6 mmol/L 11/19/12 11/19/12 11/19/12...
  • Page 72 6 • Storing Test Strip, Control Solution, and Linearity Solution Information in the Meter Once you have finished updating the test strip informa- Control L2 Max 12:48 tion, you can use the next screen to select the lot number 21.6 mmol/L you are currently editing as the current lot number.

  • Page 73: Storing Control Solution Information

    Storing Test Strip, Control Solution, and Linearity Solution Information in the Meter • 6 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 operators to refer to.
  • Page 74 6 • Storing Test Strip, Control Solution, and Linearity Solution Information in the Meter Add Control Lot 12:48 Control Lot 12:48 Control Expiration 12:48 11/30/12 Level 1 (Lo) Level 2 (Hi) 11/19/12 11/19/12 11/19/12 Select the level (L1/Lo or L2/Hi). Use the keypad to enter the lot number.
  • Page 75 Storing Test Strip, Control Solution, and Linearity Solution Information in the Meter • 6 Once you have finished updating the control solution Control Expiration 12:48 information, you can use the next screen to select the lot 11/30/12 number you are currently editing as the current lot number.

  • Page 76: Selecting A Stored Lot Number As The Current Lot Number

    6 • Storing Test Strip, Control Solution, and Linearity Solution Information in the Meter Selecting a stored lot number as You can select any stored lot number as the current lot the current lot number number. Main Menu 12:48 Main Menu 2 12:48 Control Lots 12:48...
  • Page 77 Storing Test Strip, Control Solution, and Linearity Solution Information in the Meter • 6 Control Lots 12:48 Control Lot Details 12:48 Control Lot Details 12:48 Type Exp. Date Lot Num. Control Lot: 777732 Control Lot: 777732 Control Level: 1 Control Level: 1 * QC L2 11/21/12 777678 QC L1...

  • Page 78: Storing Linearity Test Information

    6 • Storing Test Strip, Control Solution, and Linearity Solution Information in the Meter 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 The following description assumes that the meter is linearity test powered on and the Main Menu is displayed.
  • Page 79 Storing Test Strip, Control Solution, and Linearity Solution Information in the Meter • 6 Linearity Lot 12:48 Linearity Expiration 12:48 11/30/12 11/19/12 11/19/12 Use the keypad to enter the lot number. Touch to confirm the entered lot number. Enter the expiration date (use two digits and lead- ing zero, if necessary) and touch to confirm the expiration date you have entered.

  • Page 80: Selecting A Stored Lot Number As The Current Lot Number

    6 • Storing Test Strip, Control Solution, and Linearity Solution Information in the Meter Selecting a stored lot number as You can select any stored lot number as the current lot the current lot number number. Main Menu 12:48 Main Menu 2 12:48 Linearity Lots 12:48...
  • Page 81 Storing Test Strip, Control Solution, and Linearity Solution Information in the Meter • 6 Linearity Lots 12:48 Linear. Lot Details 12:48 Linear. Lot Details 12:48 Type Exp. Date Lot Num. Linearity Lot: 777732 Linearity Lot: 777732 Use by 12/31/12 Use by 12/31/12 * Lin.
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  • Page 83: Linearity Testing

    Linearity Testing • 7 Linearity Testing 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 solutions” on page 16.

  • Page 84: Information Stored During Linearity Testing

    7 • Linearity Testing Information stored during The following information is stored for every linearity test: linearity testing Test result ■ Lot number of the linearity solution ■ Level of linearity solution (L1 to L6) ■ Operator ID (if configured) ■...

  • Page 85: Performing A Linearity Test

    Linearity Testing • 7 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 ■...

  • Page 86: Confirming Or Selecting The Lot Number For Linearity Test Kits

    7 • Linearity Testing Confirming or selecting the lot You are now prompted to confirm or enter the lot number number for linearity test kits of the linearity test kit. Compare the number displayed by the meter to the number on the label of the linearity test kit.

  • Page 87: Inserting Test Strips

    Remove the test strip from the test strip vial and close the vial again with the cap. Hold the test strip so the lettering “ACCU-CHEK” is facing upward. Slide the test strip into the test strip port as far as it will go in the direction indicated by the arrows on the test strip.

  • Page 88: Applying A Linearity Test Sample

    7 • Linearity Testing Applying a linearity test sample Once the meter has detected the test strip, you will be prompted to apply the linearity solution. Linearity Test 12:48 Linearity 12345678 L1 Strip Lot 545794 11/19/12 Wait until the flashing drop appears in the display before applying the solution.

  • Page 89: Results Screen

    Linearity Testing • 7 Results screen The hourglass icon indicates the test is running. When the test is completed and the result is ready, the meter beeps again. Linearity Test 12:48 Linearity Test 12:48 Linearity Test 12:48 Linearity 12345678 L1 Linearity 12345678 L1 Linearity 12345678 Strip Lot 545794...
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  • Page 91: Proficiency Testing

    Proficiency Testing • 8 Proficiency Testing 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 operator performing the test.

  • Page 92: Information Stored During Proficiency Testing

    8 • Proficiency Testing Information stored during The following information is stored for every proficiency proficiency testing test: Test result ■ Sample ID ■ Lot number of the test strips ■ Time and date of test ■ Comments (if applicable) ■...

  • Page 93: Performing A Proficiency Test

    Proficiency Testing • 8 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. ■...

  • Page 94: Entering The Proficiency Sample Id

    8 • Proficiency Testing Entering the proficiency sample You will now be asked to enter the sample ID. Use the keypad to manually enter the sample ID, or Sample ID 12:48 Press and release to read the sample ID from the sample vial via barcode scanner (see page 37).

  • Page 95: Inserting Test Strips

    Remove the test strip from the test strip vial and close the vial with the cap. Hold the test strip so the lettering “ACCU-CHEK” is facing upward. Slide the test strip into the test strip port as far as it will go in the direction indicated by the arrows on the test strip.

  • Page 96: Applying A Proficiency Sample

    8 • Proficiency Testing Applying a proficiency sample Once the meter has detected the test strip, you are prompted to apply the proficiency sample. Profi ciency Test 12:48 Sample 123456789 Strip Lot 545794 11/19/12 Wait until the flashing drop appears in the display before applying the sample.

  • Page 97: Results Screen

    Proficiency Testing • 8 Results screen The hourglass icon indicates the test is running. When the test is completed and the result is ready, the meter beeps again. Profi ciency Test 12:48 Profi ciency Test 12:48 Profi ciency Test 12:48 Sample 123456789 Sample 123456789 Sample 123456789...
  • Page 98 8 • Proficiency Testing This page intentionally left blank.

  • Page 99: Initial Startup

    To ensure continuous safe and reliable operation, use only the power supply unit provided for the Accu-Chek Inform II system (for ordering information see page 145). Slide the base unit upward and remove it from the wall mount (if in use).

  • Page 100: Installing Or Replacing The Battery Pack

    9 • Initial Startup 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.

  • Page 101: Removing The Battery Pack

    Initial Startup • 9 Removing the battery pack If a battery pack is already installed, make sure that the meter is switched off. Place the meter face down on a level surface. Using a Torx screwdriver size T5, remove the two screws holding the battery pack in place.

  • Page 102: Installing The Battery Pack

    9 • Initial Startup Installing the battery pack Loosen the screws on the battery pack until they are protruding about 4-5 mm (2/10 in). Position the battery pack alongside the meter so that the plug connector is level with the socket inside the meter.
  • Page 103 Initial Startup • 9 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.
  • Page 104 9 • Initial Startup 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).

  • Page 105: Docking The Meter

    Note: The following displays appear on the meter when it is docked in an Accu-Chek Inform II Base Unit or an Accu-Chek Inform II Base Unit Light and communicating. The same displays appear whether the meter is transferring data via base unit or via RF card (wireless connection).
  • Page 106 9 • Initial Startup This display is visible when communication is still active Docked 12:48 but the meter is busy processing the data received or waiting for the next data message from the DMS. Busy... 11/19/12 This display is visible when no communication is taking Docked 12:48 place.

  • Page 107: Initial Setup On The Meter

    Initial Startup • 9 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.

  • Page 108: Menu Overview

    9 • Initial Startup 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 –...
  • Page 109 Initial Startup • 9 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 –...
  • Page 110 9 • Initial Startup 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 –...

  • Page 111: Opening The Setup Menu

    Initial Startup • 9 Opening the Setup Menu All settings described here are configured via the Setup Menu. To open the Setup Menu, proceed as follows: Main Menu 2 12:48 Admin Menu 12:48 Setup Menu 12:48 Maintenance Beeper Date / Time Date / Time Reagents Profi...

  • Page 112: Date And Time Format

    9 • Initial Startup Date and time format Use this menu to select the date and time format for the Date/Time Options 12:48 display. You can also choose whether the operator is Date/Time Editing: allowed to edit date and time (optionally with password Allowed required).

  • Page 113: Display Options And Optional Tests

    Initial Startup • 9 Display options and optional tests Use this menu to select the unit of measure for test Test Disp. Options 12:48 results and enable or disable optional tests. Display Strip Limitations Warning Touch the desired option to enable it: Result Units: mg/dL Result Units...

  • Page 114: Options For Test Strips

    9 • Initial Startup Options for test strips This menu allows you to select options for handling lot Reagent Options 12:48 numbers and specify whether the operator is allowed to Reagent Editing: edit the expiration date and limit values on the meter Allowed (optionally with password required).
  • Page 115 Initial Startup • 9 On the second settings screen, you can select options for Reagent Options 12:48 handling lot numbers with glucose control and linearity Control Lot Verifi cation: tests. Display only Confi rmation Touch the desired option to enable it: Lot entry Scan only Control Lot Verification...

  • Page 116: Options For Glucose Control Tests

    9 • Initial Startup Options for glucose control tests This menu contains options that allow you to specify QC Frequency 12:48 whether and at what intervals glucose control tests are Control Frequency: performed. If you require control tests, check your set- Always OK tings for STAT tests (see page 113).

  • Page 117: Value Ranges (Normal, Critical, Reportable)

    Initial Startup • 9 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 institution defined range for reporting patient results.

  • Page 118: 9.11 Options For Operator Id Entry

    9 • Initial Startup 9.11 Options for Operator ID Entry This menu allows you to specify if and how operator login Operator ID Entry 12:48 is performed. Operator Entry: None Touch the desired option to enable it: Prompt Scan only Operator Entry ■...

  • Page 119: 9.12 Patient Id Options

    Initial Startup • 9 9.12 Patient ID options This menu allows you to specify the criteria for entering a Patient ID Options 12:48 patient ID. Patient Entry: Prompt Touch the desired option to enable it: Prompt (numeric only) Scan only Patient Entry ■...

  • Page 120: 9.13 Creating A Setup Password

    9 • Initial Startup 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. Please note that password protection can only be reset or modified after entering the current password.

  • Page 121: 9.14 Setting The Date And Time

    Initial Startup • 9 9.14 Setting the date and time This setting can be hidden or require entry of a password, based on configuration. Main Menu 12:48 Main Menu 2 12:48 Admin Menu 12:48 Maintenance Beeper Date / Time Patient Test Profi...

  • Page 122: 9.15 Beeper Options

    9 • Initial Startup 9.15 Beeper options This setting can be used to set the volume of the beeper. Main Menu 12:48 Main Menu 2 12:48 Beeper Setup 12:48 Beeper Volume: Maintenance Beeper Patient Test Profi ciency Diagnostics Medium Control Test Strip Lots Linearity High...

  • Page 123: 9.16 Diagnostics View

    Initial Startup • 9 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. Main Menu 12:48 Main Menu 2...
  • Page 124 9 • Initial Startup Diagnostics 12:48 Diagnostics 12:48 Diagnostics 12:48 Confi guration: Page 3 Wireless Status: RF activated: Test Operator Validation: Associated: None S/W Version: 03.00.00 Authenticated: Patient Validation: Received IP: 192.168.4.117 BSP Version: 3.7 List - allowed to add new Last Download: 02/26/12 Subnet: Reagent Editing:...

  • Page 125: 9.17 Unlocking A Download Lockout

    Initial Startup • 9 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.
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  • Page 127: 10 Maintenance And Care

    10.1 Conditions for storage and shipping All information given on maintenance and care of the “base unit” in this chapter applies to both the Accu-Chek Inform II Base Unit and the Accu-Chek Inform II Base Unit Light. General operating conditions...

  • Page 128: Storage

    Observe the limits for temperature and humidity ■ when storing and using the meter (see Chapter 12). 10.2 Cleaning/disinfecting the Accu-Chek Inform II system Healthcare professionals should wear gloves and follow their institution’s infection control procedures when handling blood glucose testing equipment. See also safety messages “Protection against infection and blood-...

  • Page 129: Acceptable Cleaning/Disinfecting Agents

    Maintenance and Care • 10 Acceptable cleaning/ Before using a cleaning/disinfecting solution on the disinfecting agents 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- dients are acceptable for use.

  • Page 130: Cleaning/Disinfecting The Meter

    10 • Maintenance and Care 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. Avoid getting liquid into the test strip port! Moisture in the strip port may lead to incorrect blood WARNING glucose results.

  • Page 131: How To Clean/Disinfect

    Maintenance and Care • 10 How to clean/disinfect Remove the meter from the base unit prior to cleaning/disinfecting. Power off the meter. Place the meter on a level surface. Gently wipe over the surfaces (touchscreen, housing) with a soft, lint-free cloth slightly dampened (not wet).

  • Page 132: Cleaning The Barcode Scanner Window

    10 • Maintenance and Care Cleaning the barcode scanner The barcode scanner window should be cleaned periodi- window cally. Use a clean, dry cloth to wipe the barcode scanner window. Cleaning/disinfecting the base Unplug the base unit before cleaning/disinfecting. unit Wipe over the surfaces with a soft lint-free cloth slightly dampened (wring out any excess).

  • Page 133: Cleaning/Disinfecting The Accessory Box

    Maintenance and Care • 10 Cleaning/disinfecting the For cleaning, you may wipe the surfaces with a soft accessory box 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 ingredients for disinfecting the accessory box are: 0.625 % (or less) solution of sodium hypochlorite in...

  • Page 134: 10.3 Logging Maintenance Activities

    10 • Maintenance and Care 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 the meter, proceed as follows: Main Menu...

  • Page 135: 11 Troubleshooting

    Troubleshooting • 11 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 this table for help.
  • Page 136 11 • Troubleshooting Display/symptom Possible solution 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).
  • Page 137 141) – If the error persists, contact your Roche representative. Communication Problems with the Data Management System via RF The Accu-Chek Inform II Meter is – Check whether WLAN is activated on the meter (see Chapter 2) unable to communicate with the Data –...
  • Page 138 11 • Troubleshooting Display/symptom Possible solution 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 described in the following: Power-off after time specified by –...

  • Page 139: Error Messages

    Troubleshooting • 11 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, identifying the mes- sage type, and a number.
  • Page 140 11 • Troubleshooting Sample message type Description Operator ID 12:48 Invalid Scan – 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.

  • Page 141: Meter Reset

    Troubleshooting • 11 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. Place the meter face down on a level surface. Press the reset button in the middle of the battery pack using a tool such as a screwdriver or a paper clip.
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  • Page 143: 12 General Product Information

    5 to 40 °C / 41 to 104 °F at 10 - 85% RH (non-condensing) (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 * Accu-Chek Inform II Base Unit Light: only red, green.
  • Page 144 Supported barcodes Code 128, Code 39, Code 93, EAN 13, Inter- leaved 2 of 5, Codabar, GS1 DataBar Limited * Not applicable to Accu-Chek Inform II Base Unit Light Specification Accessory box Code key reader Height 85 mm / 3.35 in 18.4 mm / 0.72 in...

  • Page 145: 12.2 Further Information

    05404878001 Wall Mount Accu-Chek Inform II Base Unit Hub Equipped with power and connectivity function- 05888760001 ality for the Accu-Chek Inform II Base Unit Light Accu-Chek Inform II Battery Pack 04882326001 Accu-Chek Inform II Code Key Reader 04884671001 Accu-Chek Inform II RF Card Kit...

  • Page 146: Accu-Chek Inform Ii Operator's Manual And Quick Reference Guide

    12 • General Product Information Accu-Chek Inform II Operator’s For additional copies of the Accu-Chek Inform II Manual and Quick Reference Operator’s Manual and Quick Reference Guide or copies Guide in other languages, please contact your local Roche organization. Reagents and Solutions Supplies are available through Roche Diagnostics.

  • Page 147: Information About Software Licenses

    “ROCHE HBU-BU Technical Note.pdf”. 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 148 12 • General Product Information This page intentionally left blank.

  • Page 149: A Appendix

    Appendix • A Appendix 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”...
  • Page 150 A • Appendix Subject/Attribute Range Default Device Custom comments 0: enabled 1: disabled Control lot verification 0: display only 1: yes / no confirmation 2: prompt for entry 3: scan only Control result display 0: value (numeric) 1: PASS / FAIL Critical range display 0: value (numeric) 1: HI / LO...
  • Page 151 Appendix • A Subject/Attribute Range Default Device Linearity lot verification 0: display only 1: yes/no confirmation 2: prompt for lot entry Display Low Power Mode time (only serial num- 0 - 120 sec (0 = Low 30 sec bers ≥ UU11030000) Power Mode off) Contrast 1 - 15...
  • Page 152 A • Appendix Subject/Attribute Range Default Device 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 Operator ID Operator ID entry control 0: None...
  • Page 153 Appendix • A Subject/Attribute Range Default Device Patient ID entry mode 0: Keyboard / Scan 1: List / Keyboard / Scan 2: Scan only 3: Prompt (numeric) Patient ID validation 0: none (Allowed characters: a-z, 0-9, 1: length “.” [period], “-” [hyphen]) 2: list 3: list allowing entry if not on list...
  • Page 154 A • Appendix Subject/Attribute Range Default Device QC time of day 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 Result deletion Result deletion algorithm.
  • Page 155 Appendix • A Subject/Attribute Range Default Device DMS port (the port number to request 0 – 65,535 open socket from the DMS. Roche recom- mends use of port numbers  1024.) 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 –...
  • Page 156 A • Appendix Subject/Attribute Range Default Device WPA Key Type 0: Passphrase 1: Key WPA Key string of 64 characters “0000000000 (HEX) 0000000000 0000000000 0000000000 0000000000 0000000000” WPA pass phrase (Un-encrypted text used 8 – 63 characters “” to generate the 256-bit preshared key.) Subject/Attribute Range Default...
  • Page 157 Appendix • A 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 / 10 charac- 1 - shared ters HEX 1 - WEP 5 - WEP104 0 - open /...

  • Page 158: Example Of Barcode Symbologies

    A • Appendix Operator and patient ID barcode masks 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 are not the same, the scan data is not a valid ID.

  • Page 159: B Appendix

    Access Point, the presence of electromagnetic disturbances, and other potential inter- fering factors, e.g., concrete walls. The Accu-Chek Inform II system is certified by the Wi-Fi Alliance. WLAN is also commonly referred to as wireless LAN or Wi-Fi, RF cards are also commonly called Wi-Fi cards.

  • Page 160: Technical Implementation

    Accu-Chek Inform II meter is using malfunctions or looses service. If the Accu-Chek Inform II meter with RF is used in an area with low signal or interferences, it is recommended to install a connected base unit for redundancy. The redundancy of the con- nected base unit allows immediate transmission of patient results when the meter is docked.

  • Page 161: Location And Type Of Rf Card

    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 supports IEEE 802.11b ■...

  • Page 162: Rf Specific Functionalities And Effective Performance Claims

    Immediately after the operator has initiated the ■ sending of a blood glucose result, the Accu-Chek Inform II meter will attempt to connect to the DMS. In line with the industry communication standard POCT1-A, the DMS must acknowledge the meter’s request for connection and actively query for the result.
  • Page 163 Appendix • B 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.
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  • Page 165: C Supplement For Other Test Entry

    Supplement for Other Test Entry • C Supplement for Other Test Entry 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 insulin type, number of units).

  • Page 166: Overview Of Other Test Entry (Ote)

    C • Supplement for Other Test Entry 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) ■...
  • Page 167 Supplement for Other Test Entry • C 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) ■...
  • Page 168 C • Supplement for Other Test Entry Entering patient test results using the Other Test Entry feature comprises the following steps: Enter the patient ID. ■ This can be done either manually or by using the barcode scanner. Enter the date and time the test was performed. ■...

  • Page 169: Recording Other Patient Tests

    Supplement for Other Test Entry • C 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 ■ the Main Menu screen is displayed. Main Menu 12:48 Patient Test Menu...
  • Page 170 C • Supplement for Other Test Entry Other Patient Tests 12:48 Other Patient Tests 12:48 Other Patient Tests 12:48 Pregnancy Fecal Occult Intermediate-Acting Insulin Visual UA (CS) Gastric Occult Long-Acting Insulin Visual UA (MS) Ketones Insulin Mixtures Rapid Strep Rapid-Acting Insulin Rapid DAT Regular Insulin 11/19/12...
  • Page 171 Supplement for Other Test Entry • C Other Patient Tests 12:48 Patient ID 12:48 Fecal Occult Gastric Occult Ketones Rapid-Acting Insulin Regular Insulin 11/19/12 11/19/12 Enter or select the Patient ID. Touch to pro- ceed to the next screen Date Tested 12:48 Time Tested 12:48...
  • Page 172 C • Supplement for Other Test Entry Fecal Card Lot 12:48 Expiration Date 12:48 131163 12/30/12 11/19/12 11/19/12 Fecal Card Lot 12:48 ID: 150 88 256 11/19/12 9:12 am Use card 131163? 11/19/12 Use the keypad or barcode scanner to enter the Fecal Card Lot number, and touch to proceed to the next screen.
  • Page 173 Supplement for Other Test Entry • C Fecal Developer Lot 12:48 Expiration Date 12:48 12/30/12 11/19/12 11/19/12 Fecal Developer Lot 12:48 ID: 150 88 256 11/19/12 9:12 am Use developer 131163? 11/19/12 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...
  • Page 174 C • Supplement for Other Test Entry Fecal Occult Patient 12:48 Fecal Occult Patient 12:48 Fecal Occult Patient 12:48 ID: 150 88 256 ID: 150 88 256 ID: 150 88 256 Positive Ctrl Negative Ctrl Result Select a positive control Select a negative control Select a Fecal Occult result.
  • Page 175 Supplement for Other Test Entry • C Fecal Occult Patient 12:48 Fecal Occult Patient 12:48 Fecal Occult Patient 12:48 ID: 150 88 256 ID: 150 88 256 ID: 150 88 256 11/19/12 D/T Tested Result negative Result negative 9:12 am 1283 Card Lot # 12/30/12...

  • Page 176: Recording Other Control Tests

    C • Supplement for Other Test Entry 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) ■...
  • Page 177 Supplement for Other Test Entry • C 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). ■...
  • Page 178 C • Supplement for Other Test Entry The following steps must be completed already: The meter is powered on. You have entered your operator ID. You have completed login by selecting the Main Menu screen is displayed. Main Menu 12:48 Control Test Menu 12:48 Other Control Tests...
  • Page 179 Supplement for Other Test Entry • C Pregnancy Ctrl Lot 12:48 Expiration Date 12:48 12/30/12 11/19/12 11/19/12 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. Use the keypad to enter the Pregnancy Ctrl Lot expiration date.
  • Page 180 C • Supplement for Other Test Entry Pregnancy Kit Lot 12:48 Expiration Date 12:48 07/30/13 11/19/12 11/19/12 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. Use the keypad to enter the Pregnancy Kit Lot expiration date.
  • Page 181 Supplement for Other Test Entry • C Pregnancy Control 12:48 Pregnancy Control 12:48 Pregnancy Control 12:48 Positive Liquid Control Positive Liquid Control Positive Liquid Control Control Bar Ctrl Result 11/19/12 D/T Tested 8:30 am Select a Pregnancy control Select a Pregnancy liquid 1283 bar result.

  • Page 182: Warning Messages

    C • Supplement for Other Test Entry 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 information may not be valid or accurate.

  • Page 183: Reviewing Other Test Results

    Supplement for Other Test Entry • C 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: The meter is powered on. You have entered your operator ID.
  • Page 184 C • Supplement for Other Test Entry Other Test Results 12:48 Fecal Occult Patient 12:48 Fecal Occult Patient 12:48 All -- 11/19/12 Page 1/2 Page 2/2 ID: 150 88 256 ID: 150 88 256 Time Type Name: Helen Schneider 12:25 150 88 256 Positive Ctrl acceptable...
  • Page 185 Supplement for Other Test Entry • C Other Test Results 12:48 Other Test Results 12:48 Other Test Results 12:48 All -- 11/19/12 ID: 150 88 256 QC -- 11/19/12 Patient -- 11/19/12 Time Type Time Type 12:25 150 88 256 Time Type 12:15...

  • Page 186: Other Test Entry Configuration Options

    C • Supplement for Other Test Entry 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.

  • Page 187: D Supplement For Observed Test Sequence

    Supplement for Observed Test Sequence • 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 operator during a test to check that the test is being performed according to the recom- mended procedures.

  • Page 188: Using The Ots Function

    D • Supplement for Observed Test Sequence Using the OTS function A request for an Observed Test Sequence comes from the DMS. Main Menu 12:48 Patient Test Menu 12:48 Observer ID 12:48 Observer Login Patient Test Glucose Test Control Test Other Test Review Results 11/19/12...
  • Page 189 Supplement for Observed Test Sequence • D Operator: Touch Glucose Test. Perform the patient test as usual. Once the test is com- pleted, the observer has to complete the next steps. Hand the meter back to the observer. Patient Test - OTS 12:48 Observer Login 12:48...
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  • Page 191: Index

    Index Index Control lots Accessory box Editing control lot data ......73–77 Cleaning/disinfecting ......... 133 Selecting .............58 Overview .............31 Storing information ......... 67–81 Adresses (Roche) ..........147 Control solution Lot number ............58 Automatic power-off ..........17 CR LO/HI ..............50 Critical range ..........50, 117 Backlight ..............34 Barcode Masks ...............
  • Page 192 Index Ordering ..............145 Icons Other Test Entry (OTE) ......165–185 Identification plate ..........4 Packaging ............4 Information service ..........147 Password ..............120 Initial startup ........... 99–124 Patient glucose testing ........39–52 Performing a test ........40–50 Preparing ............39 License (GPL) ............
  • Page 193 Index Sample Applying ........47, 61, 88, 96 Technical data ............143 Screen Telephone number (information service) ..147 Backlight ............34 Test strip lots Contrast ..............34 Storing information ......... 67–81 Setup ..........107–122, 149–158 Test strip options ..........114 Beeper .............. 122 Test strips Date and time ..........
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  • Page 196 ACCU-CHEK, ACCU-CHEK INFORM, ACCU-CHEK PERFORMA and COBAS are trademarks of Roche. Roche Diagnostics GmbH Sandhofer Strasse 116 68305 Mannheim, Germany www.roche.com www.accu-chek.com...

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