Download
Share
Print this page
Roche cobas h 232 Operator's Manual
  1. Manuals
  2. Brands
  3. Roche Manuals
  4. Medical Equipment
  5. cobas h232
  6. Operator's manual
Roche cobas h 232 Operator's Manual

Roche cobas h 232 Operator's Manual

Poc system
Hide thumbs Also See for cobas h 232:

Advertisement

Quick Links

Download this manual
cobas h 232 POC system
Operator's Manual

Advertisement

loading
Need help?

Need help?

Do you have a question about the cobas h 232 and is the answer not in the manual?

Questions and answers

Related Manuals for Roche cobas h 232

Summary of Contents for Roche cobas h 232

  • Page 1 232 POC system Operator’s Manual...
  • Page 2 Manual version Revision date Changes Version 1.0 2006-10 New document Version 2.0 2009-09 Minor revisions from internal review Version 3.0 2011-09 Update to SW 03; enhanced error messages Version 4.0 2014-05 Added description of new OTS functionality, miscellaneous minor revisions...
  • Page 3 232 POC system Operator’s Manual Version 4.0 0 4880889001 (04) 2014-05 EN...
  • Page 4 UL 61010A-1:02 and CAN/CSA-C22.2 No.61010-1-04). Laser class 1 according to IEC 60825-1 (applies only to meters with a barcode scanner, meter S/N greater than 200000) The user is fully responsible for the installation, use and upkeep of the cobas h 232 meter.
  • Page 5 Table of Contents Introduction The cobas h 232 meter........................9 Test principle ............................. 10 Contents of the Pack ........................10 1.1 Important safety instructions and additional information............11 Safety information..........................12 Disposal of the system ........................13 General care............................13 Laser scanner ............................
  • Page 6 Table of Contents 5.4 Lockout setup ............................73 Operator lockout..........................74 Quality control (QC) settings ....................... 77 Quality control (QC) lockout ......................79 Instrument quality control (IQC) lockout................. 80 QC result format ..........................81 Custom Range Troponin T ......................82 Reset test parameters........................
  • Page 7 Information about software licenses ..................150 Repairs .............................. 150 Contact Roche..........................150 Warranty Appendix 14.1 Example of barcode symbologies ....................151 14.2 Contact Roche ............................152 Supplement for Observed Test Sequence Observed Test Sequence (OTS) ..................... 159 Using the OTS function....................... 160 Index...
  • Page 8 Table of Contents This page intentionally left blank.
  • Page 9 Readings may be carried out directly where the blood samples are taken. Therefore, the cobas h 232 meter is ideal for use at the point of care in emergency rooms, intensive care units and ambulances, as well as by cardiologists and general practitioners. The cobas h 232 meter is rapid and easy to operate: Insert an unused strip in the meter and apply the sample.
  • Page 10 Two lines (signal and control line) in the detection zone of the test strip indicate whether the analyte to be determined is present in the sample material. These lines are detected by the cobas h 232 meter with the help of an LED (lighting the detection zone) and a camera sensor (imaging the detection zone).
  • Page 11 1.1 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 cobas h 232 Operator’s Manual. Please read these passages carefully. The safety alert symbol alone (without a signal word) promotes aware- ness to hazards which are generic or directs the reader to related safety information.
  • Page 12 Operators need to adhere to Standard Precautions when handling or using the cobas h 232 meter. All parts of this system should be considered potentially infectious and are capable of transmitting blood-borne pathogens between patients and between patients and healthcare professionals.
  • Page 13 Introduction Disposal of the system Infection by a potentially biohazardous instrument The cobas h 232 meter or its components must be treated as potentially WARNING biohazardous waste. Decontamination (i.e., a combination of processes including cleaning, disinfection and/or sterilization) is required before reuse, recycling, or disposal.
  • Page 14 Never run the meter if the electrical power supply or the attached cable is visibly damaged. If there is any visible damage contact your local Roche service for inspections. Electromagnetic interference Do not use the meter near strong electromagnetic fields, which could interfere with the proper operation of the meter.
  • Page 15 Wired network connection If connected to a local area network, the cobas h 232 Handheld Base Unit must be protected against unauthorized access by means of a strong password management. Observe your own...
  • Page 16 The cobas h 232 POC System The cobas h 232 POC System 2.1 Overview of the meter and its accessories Meter CLASS I LASER PRODUCT Complies with 21 CFR 1040.10 and 1040.11 except for deviations pursuant to Laser Notice No. 50, dated July 26, 2001...
  • Page 17 The cobas h 232 POC System Touchscreen Barcode scanner (Laser) Shows results, information, icons and Operator and patient IDs can be read into results saved in the memory. To select an the meter using the integrated barcode option, simply touch the button lightly.
  • Page 18 The cobas h 232 POC System Test strip guide Contacts for Handheld Base Unit Insert the test strip here. Used for power supply and/or charging the handheld battery pack, when the Reset button meter is docked in the Handheld Base Use this button to reset the meter in case Unit.
  • Page 19 The cobas h 232 POC System Test strip Test area Barcode This area is evaluated by the meter via the Assigns the strip to the corresponding camera. code chip. The barcode is automatically read by the meter when the strip is Sample application area inserted into the test strip guide.
  • Page 20 The cobas h 232 POC System Handheld Base Unit Charging contacts Data ports (Ethernet/RJ45 and USB) Used for power supply and/or charging For connecting the device to a Data the handheld battery pack. Management System (DMS). Status indicator Connection socket for the...
  • Page 21 Overview of the Buttons and Icons used on Screen Overview of the Buttons and Icons used on Screen The buttons and icons that appear during normal operation are shown here, along with a general explanation. Error messages and the description of the icons linked to them are provided in a separate chapter.
  • Page 22 Overview of the Buttons and Icons used on Screen Button/Icon Meaning Insert code chip Open test strip guide cover for cleaning Battery status: • If the handheld battery pack still has its full charge, all segments are lit • Individual segments disappear one by one as the handheld bat- tery pack becomes weaker •...
  • Page 23 Putting the Meter into Operation Putting the Meter into Operation Before using the meter for the first time, perform the following steps: Connect the handheld power supply If present, insert the handheld battery pack for recharging (see page 25) Set the current date and time as well as the appropriate display format (see Chapter “Meter Setup”...
  • Page 24 Putting the Meter into Operation Power supply The meter can be operated with either the handheld power supply (adapter/charger) provided, the (optional) Handheld Base Unit or the (optional) handheld battery pack. It is advisable to insert the handheld battery pack even when you use the handheld power supply. This ensures that you do not lose the date and time settings (in case of a power outage or if the local power supply is shut off).
  • Page 25 Putting the Meter into Operation Inserting the handheld battery pack 1 With the meter powered off, hold it so that the tab on the handheld battery pack points upward. 2 Gently press the tab on the battery com- partment cover towards the center of the meter and tilt the cover to the side.
  • Page 26 If the settings for date and time have not yet been set or if they have been lost (because the meter was without power for more than ten minutes), your cobas h 232 meter automatically switches to Setup mode when power is restored. You must enter the date and time, then the meter automatically switches to the Main Menu.
  • Page 27 Putting the Meter into Operation Powering the meter on and off 1 Power the meter on by pressing the button for approximately 1 second. You can also power on the meter directly by connecting the handheld power supply. 2 To power the meter off after use, press the button for approximately 1 second.
  • Page 28 Putting the Meter into Operation This page intentionally left blank.
  • Page 29 Meter Setup Meter Setup Buttons are screen prompts that cause something to happen when touched. The names of all buttons are either shown as bold text or as the icon used on the button (e.g., for OK ). Other screen elements (e.g., Menu titles) are written in italics. These screen elements are not active.
  • Page 30 Meter Setup Settings summary The diagram below gives an overview of the setup areas that can be accessed on the meter. Setup Basics Contrast Language Date/Time Sound Auto Off Data Handling Result Display Connection Result Memory DD Result Unit Mode ID Setup Administrator ID Operator ID...
  • Page 31 Meter Setup Group Subgroup Setting Values * Basics Contrast 0 – 10 (5*) Language Dansk Deutsch English * Español Français Italiano Nederlands Norsk Português Svenska An installable language Date/Time Date 01/01/2011 * Time 12:00 am * Date formats Day.Month.Year (31.12.2011) Month/Day/Year (12/31/2011) * Year-Month-Day (2011-12-31) Time formats...
  • Page 32 Meter Setup Group Subgroup Setting Values * Data Handling Connection Off * Computer Printer Result Memory Result Display Filter All results * Current Op. Res. Result Storage No results deletion * Mode Delete oldest result DD Result Unit μg/mL * ng/mL mg/L μg/L...
  • Page 33 Meter Setup Group Subgroup Setting Values * Lockout Operator Lockout (only if “Operator ID” No * option is enabled) Daily Weekly Monthly Every 3 months Every 6 months Yearly QC Settings QC Lockout New Lot: Yes/No * No * Daily Weekly Monthly IQC Lockout...
  • Page 34 Meter Setup Group Subgroup Setting Values * Optional screens Start Info Enable Disable * Result Login Enable Disable * Result Confirmation Enable Disable * * Default settings are labelled with an asterisk (*).
  • Page 35 Meter Setup 5.1 Basics setup The Basics setup area contains the basic options for changing the user interface. Contrast Use the Contrast menu to adjust the display to your ambient light conditions and make it easier to read. 1 From the Main Menu, touch Setup to 09:15 am Main Menu open the meter settings.
  • Page 36 Meter Setup 4 Touch to change the contrast in a range from 0 to 10. Select Contrast Contrast “0” makes the screen very dark. ■ Contrast “10” makes the screen very light. ■ 5 Touch to save this setting, or: Contrast: (0-10) Touch...
  • Page 37 ■ 04/19/2014 Language Italiano ■ Nederlands Date/Time ■ Norsk ■ Sound Português ■ Auto Off Svenska ■ 04/19/2014 An optional language can be installed upon request (either directly at the plant or later by an authorised Roche Diagnostics service technician).
  • Page 38 Meter Setup 4 Touch to display the lan- guage of choice on the screen. Select Language If the arrow is just an outline , you Français have reached the end of the list in the respec- tive direction. Italiano Nederlands 5 Touch the button to select the language of choice.
  • Page 39 Meter Setup Setting the date Use this menu to set the date of the meter. 1 From the Main Menu, touch Setup to Main Menu 09:15 am open the meter settings. Patient Test 2 From the Setup menu, touch Basics. 3 From the Setup-Basics menu, touch Control Test Date/Time.
  • Page 40 Meter Setup 4 From the Setup-Date/Time menu, touch Setup - Date/Time Date to set the date. Date 5 Touch to set the year, then Set Date Time 2014 the month, then the day. Year: Date/Time Format 6 Touch to save this setting, or: Month: Touch to exit this menu without...
  • Page 41 Meter Setup Setting the time Use this menu to set the time of the meter. 1 From the Main Menu, touch Setup to Main Menu 09:15 am open the meter settings. Patient Test 2 From the Setup menu, touch Basics. 3 From the Setup-Basics menu, touch Control Test Date/Time.
  • Page 42 Meter Setup 4 From the Date/Time menu, touch Time to Setup - Date/Time set the time. Date 5 Touch to set the hours, then Set Time Time the minutes. Hour: Date/Time Format 6 Touch to save this setting, or: Minutes: Touch to exit this menu without saving any changes.
  • Page 43 Meter Setup Setting the display options for date and time Select your preferred format for the date and time display. 1 From the Main Menu, touch Setup to Main Menu 09:15 am open the meter settings. Patient Test 2 From the Setup menu, touch Basics. 3 From the Setup-Basics menu, touch Control Test Date/Time.
  • Page 44 Meter Setup Setup - Date/Time 4 From the Setup-Date/Time menu screen, touch Date/Time Format to set the dis- Date play format. Select Date Format Time Date: DD.MM.YYYY Date/Time Format The current settings are highlighted (white MM/DD/YYYY type on a blue background). You can select one of the following display formats for the YYYY-MM-DD date:...
  • Page 45 Meter Setup Sound The cobas h 232 meter can display information visually and alert you to special circumstances with a beep sound. When the Sound is activated, the meter beeps when: it is powered on ■ it detects a test strip ■...
  • Page 46 Meter Setup 1 From the Main Menu, touch Setup to 09:15 am Main Menu open the meter settings. Patient Test 2 From the Setup menu, touch Basics. 3 From the Setup-Basics menu, touch Control Test Sound. Review Results Setup Setup Basics 04/19/2014 Data Handling...
  • Page 47 Meter Setup Setup - Sound 4 From the Setup-Sound menu, touch Volume to set the volume level of the Volume beeper. Select Volume Key Click The current setting is highlighted (white type on a blue background). You may select from the following options: Medium ■...
  • Page 48 Meter Setup Auto off You can set up your meter so that it powers itself off automatically if it has not been used (no buttons touched or tests run) for a preselected time period. Use this feature to save power and extend the life of the batteries.
  • Page 49 Meter Setup You may select from the following options: Set Auto Off Time Off (meter never powers itself off) ■ Time until meter powers itself off: ■ 1…10, 15, 20, 25, 30, 40, 50, 60 minutes Minutes: 4 Touch to select the time of choice in minutes or to deactivate the feature.
  • Page 50 Meter Setup 5.2 Data Handling setup Connection In the Select Connection menu you can configure the data exchange with external devices. The meter can be connected either to a computer or a printer. 1 From the Main Menu, touch Setup to 09:15 am Main Menu open the meter settings.
  • Page 51 Meter Setup Computer The cobas h 232 meter can connect with a computer or host system running appropriate soft- ware (that is, a DMS must be installed). To use this connectivity feature, however, you need the optional Handheld Base Unit. The connection is established in two steps.
  • Page 52 Meter Setup Printer The meter can connect directly with three different infrared printers. The Handheld Base Unit cannot be used for this purpose. The option to print is displayed in a test result as well as directly after a test and when calling up stored results.
  • Page 53 Meter Setup 4 Touch Printer. Your selection is now Select Connection highlighted. Select Printer 5 Touch to confirm the selection. The Computer next screen allows you to choose the type Citizen CMP-10 Printer of printer you are using. GeBE GPT-437x 6 Touch to save this setting, or: Zebra MZ 320...
  • Page 54 Meter Setup Result memory Result memory settings allow to apply a Result Display Filter and to set the Result Storage Mode (see page 56). All results recorded by the meter (patient results and quality controls) are stored automatically. Use the Sel. Res. Display Filter menu to select whether to display results (when calling up the Memory function) for all existing tests or only those from the current operator.
  • Page 55 Meter Setup Setup - Result Memory 4 From the Setup-Result Memory menu, touch Result Display Filter to select the Result Display Filter results to display. Sel. Res. Display Filter Result Storage Mode The current setting is highlighted (white type All Results on a blue background).
  • Page 56 Meter Setup The Sel. Res. Storage Mode menu tells the meter what to do when the memory is full. The meter memory can store a maximum of 500 patient tests, 500 liquid controls, and 200 instrument quality controls. In case of a full memory, you can choose between: No Result Deletion.
  • Page 57 Meter Setup Result unit The result unit setting applies to the result display of D-Dimer tests only. 1 From the Main Menu, touch Setup to Main Menu 09:15 am open the meter settings. Patient Test 2 From the Setup menu, touch Data Handling.
  • Page 58 Meter Setup Select DD Res. Unit 4 From the Select DD Res. Unit menu, select the unit to be used for the D-Dimer result µg/mL display. ng/mL mg/L The current setting is highlighted (white type on a blue background). You may select from µg/L the following options: μg/mL...
  • Page 59 Meter Setup Result display mode Test results may be displayed either with a static or a flashing display, the latter visually indicat- ing that the measurement process has been finished. Once a result is available, the display starts flashing. Depending on the settings, this may be either a quantitative or qualitative result screen or an operator login screen.
  • Page 60 Meter Setup Select Res. Display Mode 4 From the Select Res. Display Mode menu, select your display mode. Static Flashing The current setting is highlighted (white type on a blue background). You may select from the following options: Static ■ Flashing ■...
  • Page 61 It is not necessary for administrator identification to be activated to use the cobas h 232 meter. However, it might be desired or necessary, depending on the regulatory environment and the site of use.
  • Page 62 If you forget the Administrator ID, the meter setup may be unlocked via the external data man- agement system (e.g., cobas IT 1000). If you don’t use such a system and need to reset the Administrator ID, contact your Roche representative (see Chapter 12).
  • Page 63 Meter Setup If an Administrator ID has not been set up yet: 1 From the Main Menu, touch Setup to 09:15 am Main Menu open the meter settings. Patient Test 2 From the Setup menu, touch ID Setup. 3 From the Setup-ID Setup menu, touch Control Test Administrator ID.
  • Page 64 4 Using the onscreen keypad, enter the Enter Administrator ID Administrator ID of choice (or the pass- ****| word provided by Roche Diagnostics). The ID can consist of up to 20 alpha- numeric characters. Pay close attention to the buttons you press, because the characters are not displayed on the screen.
  • Page 65 Meter Setup 9 Enter the Administrator ID again (the Repeat Administrator ID onscreen keypad is automatically dis- ****| played again) to confirm the first entry. Touch to save this entry, (the Administrator ID is now set), or Touch to exit this menu, the Administrator ID is not set and is therefore still inactive.
  • Page 66 Meter Setup Changing an existing Administrator ID: 1 From the Main Menu, touch Setup to Main Menu 09:15 am open the meter settings. Patient Test 2 From the Setup menu, touch ID Setup. 3 Using the onscreen keypad, enter the Control Test valid Administrator ID.
  • Page 67 Meter Setup Disabling an existing Administrator ID: 1 From the Main Menu, touch Setup to Main Menu 09:15 am open the meter settings. Patient Test 2 From the Setup menu, touch ID Setup. 3 Using the onscreen keypad, enter the Control Test valid Administrator ID.
  • Page 68 Meter Setup Operator ID In the default setting, the Operator login is not activated. You can either activate or deactivate Operator login on the meter. If activated, an Operator has to log in before the Main Menu will be displayed and measurements can be performed. Without a list, operators can log in directly by entering their operator name.
  • Page 69 Meter Setup 6 Select the form for input of the Operator Operator ID You may select from the following options: Alphanum. Alphanum. (alphanumeric) Numeric ■ Enter any combination of letters and numbers, e.g., “J. DOE 3378” Max. Length: Numeric ■ Enter numbers only, e.g., “3387”...
  • Page 70 Meter Setup If you want to create a list of Operator IDs from which you can select an operator, additional software (a data management system) and the Handheld Base Unit are required (for more details see “Data handling”, starting on page 132). With an Operator list being transferred to the meter, the Operator ID options are different from the options in “standalone”...
  • Page 71 Meter Setup Patient ID Patient IDs help you to assign stored results to individual patients. In the default setting, input of Patient IDs is set to No. This means that a consecutive number is assigned to each test. However, you can require that a Patient ID must be entered or make it optional. If you want to create a list of Patient IDs from which you can select a patient for testing, addi- tional software (a data management system) and the Handheld Base Unit are required (see page 132).
  • Page 72 Meter Setup 6 Select the form for input of the Patient ID before each test. Patient ID You may select from the following options: Alphanum. Alphanum. (alphanumeric) Numeric ■ Enter any combination of letters and numbers, e.g., “J. DOE 3378” Max.
  • Page 73 Meter Setup 5.4 Lockout setup The Lockout menu contains the options for quality control tests that the operator is required to perform at specified intervals or based on specific triggers. This is a list of the available lockout options: Operator Lockout ■...
  • Page 74 Meter Setup Operator lockout To perform a test with the meter, the individual steps must be performed properly. Quality control tests can be performed on a regular basis by every operator to ensure these steps are performed properly. By activating the operator lockout, operators are required to perform regular quality control tests.
  • Page 75 Meter Setup 4 Select the time interval of choice in which the required quality control tests must be performed. You may select from the following options: No (deactivated) ■ Daily ■ Weekly ■ Monthly ■ Every 3 or 6 months ■...
  • Page 76 Meter Setup 8 Quality control tests may include one or Select Operator Lockout two levels. Select the number of levels No of Levels which must be performed (not applicable, One Level if you selected No). Two Levels 9 Touch to save this setting, or: Touch to exit this menu without saving any changes.
  • Page 77 Meter Setup Quality control (QC) settings QC Settings define that operator-independent quality control tests must be run on a regular basis. Lockouts may be triggerd by selectable time periods, and lockouts may be triggered by certain events. The QC Settings menu contains the following options: QC Lockout (time-based), with the additional option of a New Lot Lockout (applies every ■...
  • Page 78 Meter Setup 1 From the Main Menu, touch Setup to 09:15 am Main Menu open the meter settings. Patient Test 2 From the Setup menu, touch Lockout. 3 From the Setup-Lockout menu, touch Control Test QC Settings. Review Results Setup Setup Basics Data Handling...
  • Page 79 Meter Setup Quality control (QC) lockout A QC Lockout requires a quality control test to be performed. You may also set the number of levels for this test. You may select from the following options: New Lot: Yes/No (applies every time a new test strip lot is used) ■...
  • Page 80 Meter Setup Instrument quality control (IQC) lockout An IQC Lockout also requires a quality control test with dedicated IQC test strips to be per- formed. You may select from the following options: ■ Daily ■ Weekly ■ Monthly ■ All enabled IQC Lockouts, if the time period has elapsed, are activated at 8:00 a.m. (default set- ting, time can be changed with a DMS).
  • Page 81 Meter Setup QC result format The QC Result format defines the kind of information that is displayed in a QC result screen. You may select from the following options: Display without a value, but with text “Pass” or “Fail” ■ Display a value ■...
  • Page 82 The quality control range for Troponin T can be customized to comply with local guidelines. The Custom Range Trop. T function enables you to narrow the default range. Default Range: The meter displays the quality control range provided by Roche in the ■...
  • Page 83 Meter Setup If you selected Custom Range, the Custom Custom Range Trop. T Custom Range Trop. T Range screen opens and offers you the option of customizing the deviation from target value Deviation from target Default Range value (in %): (percentage value).
  • Page 84 Meter Setup Reset test parameters Under certain circumstances, it may be necessary to delete the test parameters stored in the meter (for example, if a lockout exists for a test strip lot that is no longer available). However, do not use this method for overriding lockouts in general because, after resetting the test parame- ters, the meter may go into a QC lockout (if configured).
  • Page 85 Meter Setup Cleaning lockout Under normal handling conditions, your meter will not be exposed to significant dirt or contami- nation. However, circumstances might require regular checks of the test strip guide and (when necessary) cleaning of the meter. The Cleaning Lockout allows operators to specify time intervals for cleaning.
  • Page 86 Meter Setup STAT test configuration Quality control tests ensure consistent quality and accurate measurements. In emergency situa- tions, however, it may be necessary to perform a test without delay. To override an active lockout for a test parameter, lot or operator, you can allow for STAT Tests (STAT = Short TurnAround Time).
  • Page 87 Meter Setup 1 From the Main Menu, touch Setup to open 09:15 am Main Menu the meter settings. Patient Test 2 From the Setup menu, touch Lockout. 3 From the Setup-Lockout menu, touch Control Test STAT Test Config. Review Results 4 Touch Enable to allow STAT Tests or: Setup Setup...
  • Page 88 Meter Setup 5.5 Optional Screens setup In this screen, you can customise display formats and test procedures. You can choose to display additional information and select from options for managing the result display. 1 From the Main Menu, touch Setup to 09:15 am Main Menu open the meter settings.
  • Page 89 Meter Setup The additional status information is displayed after powering on the meter or after logging off as an operator. This includes information about current lockouts, the number of results not trans- ferred (to the DMS) and the time since the last data transfer. 3 Touch Start Info.
  • Page 90 Meter Setup In some circumstances, it may be useful for operators to confirm the validity of their results. To do so, an option can be enabled that prompts operators to confirm the results of every test. 9 Touch Result Confirmation. Setup - Optional Screens Res.
  • Page 91 The Roche CARDIAC family includes several strips. Always ensure that the disposables you are using (e.g., test strips) are intended for use with the cobas h 232 meter. Some tests might require a minimum software version. Ensure that the software version on the cobas h 232 meter is compatible with the test you are running (refer to the corresponding package insert for details).
  • Page 92 IMPORTANT NOTE: Do not use Roche CARDIAC pipettes for blood sampling from the vein or for injections. Roche CARDIAC pipettes are intended only for drawing the sample from the blood collection tube and applying it to the test strip. See page 106.
  • Page 93 Performing a Test 6.1 Preparing to test 1 Prepare the required test strips (shown here: Roche CARDIAC T Quantitative for testing Troponin T). 2 Make sure that the code chip supplied with these test strips is also at hand. Code chip The code chip provides the meter with important information on the manufacturer-specific parameters of the respective test strip lots.
  • Page 94 Performing a Test Roche recommends keeping the code chip in the meter to protect the contacts from becom- ing dirty. Protect the code chip from moisture and equipment which produces magnetic fields. Once the test strip lot is used up, dispose of the old code chip promptly to prevent mix-ups.
  • Page 95 Performing a Test Test steps (overview) The following illustration shows the steps performed during testing. The steps you actively per- form are displayed with a dark background. Depending on the configuration, the individual steps shown here may include additional actions (e.g., entering a password). Some steps may be dif- ferent, working with or without Operator IDs and Patient IDs.
  • Page 96 Performing a Test Powering on the meter 1 Power the meter on by pressing the button for approximately 1 second. You can also power on the meter directly by connecting the handheld power supply. The meter performs a self-check at startup.
  • Page 97 Performing a Test Logging in The initial steps until the Main Menu is displayed depend on the configuration and are performed as follows: Without operator login required 2 Wait until the main menu is displayed. 09:15 am Main Menu Patient Test Control Test Review Results Setup...
  • Page 98 Performing a Test With operator login (list available) 2 If an operator list exists, wait until this list 09:15 am Select Operator ID is displayed. OP003 Hall, Molly-Jessica 3 Touch to scroll through the OP001 Hughes, Adam list. Select the operator of choice by OP002 touching the corresponding button.
  • Page 99 Performing a Test 4 Enter the password. Password ****| 5 Touch to confirm your entry, or: Touch to display the operator list again. 6 Wait until the main menu is displayed. When the tests are completed or another 09:15 am Main Menu operator wants to perform additional tests, touch Logout to log out.
  • Page 100 Performing a Test 6.2 Performing a test 1 Check the charge level of the handheld 09:15 am Main Menu battery pack. If there are no bars left in the battery icon, you cannot perform any Patient Test more tests. 2 Check that the date and time are correct. Control Test Correct any incorrect settings as Review Results...
  • Page 101 Performing a Test Without patient list 3 Touch Patient Test. 4 If you selected the Patient ID as optional, Patient ID you can enter or scan a Patient ID. PID111SCHULZM457 If you selected the Patient ID as required, you must enter or scan the Patient ID. If you selected no Patient ID (None), the meter automatically proceeds to the next step.
  • Page 102 Performing a Test With patient list 3 Touch Patient Test. Patient lists can only be created on a DMS and must be transferred to the meter. Lists cannot be created on the meter. 4 Touch to scroll through the Select Patient ID list.
  • Page 103 Performing a Test The Patient ID can also be entered via bar- Select Patient ID code (meters with a barcode scanner only). PID001GERTA123 Anders, Gert Touch Scan and hold either PID001BERNDH123 Bernd, Hans a card with the barcode approx. 10 cm ■...
  • Page 104 Performing a Test Inserting a test strip 1 The test strip icon prompts you to insert a Pat. Test - Ins. Strip test strip. Remove the test strip from its Pat: PID111SCHULZM457 SCHULZ, MANFRED foil pouch. JONES, TOM 2 Hold the test strip so that the application and test area is facing up.
  • Page 105 Performing a Test If you use a new test strip lot, you must insert Pat. Test - Ins. Chip the corresponding code chip once. See “Code chip” on page 93. Par: proBNP Depending on the meter setting, you may also Insert Code be required to run a quality control test at this Chip...
  • Page 106 Performing a Test 4 Using the Roche CARDIAC pipette, draw exactly 150 μL (to the blue mark on the pipette) heparinized blood from the blood collection tube. Make sure the sample contains no air bubbles. 5 Apply the entire sample to the sample application area of the test strip.
  • Page 107 Trop T Code: TT 2721 (TnT Elevated) appears under the hourglass icon (see illustration). The quantitative result is displayed when the test is completed. Refer to the Roche 10:20 Min CARDIAC T Quantitative package insert for TnT Elevated more details. 04/19/2014...
  • Page 108 Performing a Test The test result is shown and stored automati- Pat. Test - Result Pat: PID111SCHULZM457 cally. SCHULZ, MANFRED JONES, TOM Par: proBNP Code: PB1234 When interpreting your result, please read the test strip package insert carefully. 01/25/2014 10:17 pg/ml 04/19/2014 Print button:...
  • Page 109 Performing a Test Displaying, confirming or adding comments to results As described in the chapter “Optional Screens setup” starting on page 88, there are many options for displaying results that can be activated: If a new Operator Login is required to display the result: 1 Touch the button for Operator Login.
  • Page 110 Performing a Test If the test result requires a confirmation: Pat. Test - Confi rm. Pat: PID111SCHULZM457 SCHULZ, MANFRED When the result is displayed, touch the ■ JONES, TOM Par: proBNP Code: PB1234 button to select the confirmation of choice. 01/25/2014 10:17 pg/ml You can choose to either...
  • Page 111 Performing a Test You can add up to three comments to a test result. Comments can provide, for example, addi- tional information about the test conditions or the patient. A comment may be up to 20 charac- ters in length. You can open the function for adding comments directly in the results screen. If you want to add a comment, do not remove the test strip.
  • Page 112 Performing a Test STAT tests STAT tests are a limited number of tests that can be performed in emergency situations, see page 86. If the meter is configured to perform STAT tests, you have the option of performing a test by choosing STAT even though a QC Lockout is in place. 1 To perform the measurement without Pat.
  • Page 113 Control Testing and Quality Control Control Testing and Quality Control The cobas h 232 POC system employs several methods to check that the meter and test strips are working properly and that the operator is performing the test correctly. The meter has a number of built-in quality control functions: A self-check of the electronic components and functions every time the meter is powered ■...
  • Page 114 Control Testing and Quality Control Always refer to the package insert provided with the control material for specific handling and testing instructions. Reconstituted control material taken from the refrigerator must be allowed to reach room temperature before use. You can specify the frequency of quality control tests according to your own requirements (see “Meter Setup/Lockout setup”...
  • Page 115 Control Testing and Quality Control 7.2 Performing a quality control test Quality control (QC) 1 Power the meter on by pressing the button for approximately 1 second. You can also power on the meter directly by connecting the handheld power supply. To power the meter off after use, press the button for approximately 1 second.
  • Page 116 Control Testing and Quality Control 3 Touch Control Test. 09:15 am Main Menu 4 In the QC Status screen, touch continue with the quality control test. Patient Test QC Test - QC Status 5 The test strip icon now prompts you to QC Status Control Test insert a test strip.
  • Page 117 Control Testing and Quality Control If you use a new test strip lot and have not inserted the code chip yet, you must do so now. Otherwise you cannot perform a quality control test. As with the test strips, a code chip is also pro- QC Test - Sel.
  • Page 118 Control Testing and Quality Control 9 If the control material box contains more QC Test - Sel. QC Level than one level, select the level of choice Par: proBNP Code: PB1234 PBC014 for this measurement. JONES, TOM Level 1 Level 2 04/19/2014 The thermometer icon shows that the test QC Test - Warming Up...
  • Page 119 Control Testing and Quality Control 10 Using the pipette, draw up the dissolved contents of the vial. 11 Apply the sample (exactly 150 μL) to the application area of the test strip. Always place the meter on a level, vibration- free surface when applying the sample to the sample application area of the test strip.
  • Page 120 Control Testing and Quality Control The time remaining for the test is displayed. QC Test - Measuring Par: proBNP Code: PB1234 PBC014 Level: JONES, TOM Measurement time: The time needed to run a test depends on the test parameter (refer to package insert for details).
  • Page 121 “Pass”, “Fail” or the percentage of remission depending on your settings. “Pass” means that the optical system of the cobas h 232 POC system is functioning properly. If “Fail” appears, the measured reflectance value is outside the confidence interval.
  • Page 122 Control Testing and Quality Control The first steps in this quality control test are identical to the procedure described before, see page 115. The following description therefore starts at the main menu. 3 Touch Control Test. Main Menu 09:15 am 4 Touch in the QC Status screen to Patient Test...
  • Page 123 Control Testing and Quality Control The hourglass icon is displayed and the (inter- QC Test - Measuring Par: Code: IQC702 nal) measurement begins. Level: JONES, TOM 04/19/2014 The result of this IQC quality control test is QC Test - Result Par: Code: IQC702...
  • Page 124 Control Testing and Quality Control This page intentionally left blank.
  • Page 125 Review Results Review Results The cobas h 232 meter can save 500 patient test results as well as 500 quality control tests to memory, together with time, date, lot number and, if applicable, IDs and comments. Reviewing test results 1 Power the meter on by pressing the button for approximately 1 second.
  • Page 126 Review Results From the Main Menu you have access to all stored results, sorted by selectable criteria: Patient History ■ All Results ■ QC Results (Quality Control) ■ IQC Results (Instrument Quality Control) ■ Maintenance History ■ 3 Touch Review Results. Main Menu 09:15 am Review Results...
  • Page 127 Review Results Patient history This memory area contains a list of all patients, sorted by Patient ID. From here, you can call up results for any individual patient. 1 Touch to display the entry of Pat. History - Select ID choice on the screen.
  • Page 128 Review Results All results This memory area contains a list of all tests, sorted chronologically. From here, you can call up results for specific times. 1 Touch to display the entry of All Results choice on the screen. Doe, John 02/15 10:52 Trop-T 2 Touch the patient name whose result you Smith, Adam...
  • Page 129 Review Results Quality control (QC) results This memory area contains all test parameter-specific quality control tests (QC, starting on page 115) that were run, sorted chronologically. The most recent results are at the top of the list. 1 Touch to display the entry of QC Results choice on the screen.
  • Page 130 Review Results Instrument quality control (IQC) results This memory area contains all instrument quality control tests (IQC, starting on page 121) that were run, sorted chronologically. The most recent results are at the top of the list. 1 Touch to display the entry of IQC Results choice on the screen.
  • Page 131 Review Results Maintenance history Maintenance History actually is a list of comments. Whenever routine maintenance or service is done for the meter, this event can be stored in form of a comment. You may use the default preset comments in the meter or enter a custom comment. 1 Touch to display the entry of Maintenance History...
  • Page 132 When used in conjunction with the Handheld Base Unit from Roche (available separately), the cobas h 232 meter can conveniently connect to a data management system (DMS). The main advantages of such a connection between meter and DMS may include: Transferring patient lists, operator lists, and settings from the DMS to the meter.
  • Page 133 Extended Functionalities Computer (Setup option) For initial connection to a DMS, the ability to communicate within a network has to be set up as follows: In the Setup menu, the Connection option must be set to Computer (see page 51). ■...
  • Page 134 Extended Functionalities Operator lists After powering the meter on, an Operator login may be configured. If no list is available, the options described on page 68 apply. Operator is set to Optional or Required: ■ The Operator can either log in via the onscreen keypad or a barcode scan. The use of the meter is not restricted to a predefined Operator group, so Operator IDs are entered via the onscreen keypad or read from the barcode and stored with test results for informational purposes only.
  • Page 135 Extended Functionalities Patient lists When starting a Patient Test, there will be the option of either selecting a Patient ID from a patient list, entering the Patient ID using the onscreen keypad or, if available, of scanning the barcode with the Patient ID. The Patient ID, if entered on the DMS, comes with an additional identification entry.
  • Page 136 Extended Functionalities Barcode scanner Using a DMS, the barcode scanner may be configured to accept only selected barcode symbol- ogies. Furthermore, it is possible to define a barcode mask for Patient ID and Operator ID. With masks being defined, the meter checks a barcode after scanning and rejects it, if it does not match the mask.
  • Page 137 Extended Functionalities The default preset comments in the meter are: Patient and QC Result comments Maintenance comments Symptomatic Meter Cleaned ■ ■ Asymptomatic Samp. App. Area Cl. (Sample Application ■ ■ Area Cleaned) Chest Pain ■ Test Strip Guide Cl. (Test Strip Guide ■...
  • Page 138 Extended Functionalities This page intentionally left blank.
  • Page 139 Cleaning and Disinfecting the Meter 10 Cleaning and Disinfecting the Meter Observe the disinfection guidelines of your institution. ■ Use gloves. ■ NOTICE Follow the procedures below to clean/disinfect the meter. Failure to follow these procedures may cause malfunction of the meter. Make sure the meter is powered off.
  • Page 140 Cleaning and Disinfecting the Meter Recommended cleaning/disinfecting solutions Use only the following solutions for cleaning/disinfecting the meter (housing and the test strip guide cover). Ammonium chloride solution (2 %) ■ Diluted bleach solution (1:10) ■ Mild soapy water ■ Citric acid (2.5 %) ■...
  • Page 141 Cleaning and Disinfecting the Meter Cleaning after contamination due to mispipetting Observe the following precautions to prevent instrument damage Do not move the meter to prevent liquids from creeping and penetrating the meter. ■ Dab away all visible blood (also on the test strip, but not in the application area). ■...
  • Page 142 Cleaning and Disinfecting the Meter Cleaning the test strip guide cover 1 If required, remove the meter from the Handheld Base Unit and place it horizon- tally on a table. 2 Remove the test strip guide cover by pull- ing it forward horizontally (in the direction of the arrow).
  • Page 143 Cleaning and Disinfecting the Meter Cleaning the visible area of the test strip guide 1 Clean the easily accessible and visible pipetting field area of the test strip guide with a moistened cotton swab/bud or tissue. Then dry the test strip guide with a fresh tissue.
  • Page 144 Cleaning and Disinfecting the Meter This page intentionally left blank.
  • Page 145 Troubleshooting 11 Troubleshooting The cobas h 232 meter continually checks its systems for unexpected and unwanted conditions. These may arise for technical reasons (defective components or consumables, environmental factors) or due to handling and procedure errors. Depending on the circumstances, a message may appear on the display of the meter. These...
  • Page 146 Troubleshooting Errors and unusual behavior without error messages Some conditions may arise that have no associated error or status message. Message Description No message or unusual behavior Wait 10 seconds and try powering on the unit again. ■ Meter display does not power on Check that the meter has power.
  • Page 147 General Product Specifications 12 General Product Specifications 12.1 Operating conditions and technical data Technical data Temperature range 18-32 °C Relative humidity 10-85% (no condensation) Maximum altitude 4000 m Position Always place the meter on a level, vibration-free surface when applying the sample to the sample application area of the test strip.
  • Page 148 10 tests for quantitative detection of cardiac 04877772190 (Troponin T) Troponin T Roche CARDIAC Control Troponin T Control set for use with Roche CARDIAC T 04890515190 Quantitative (control set for 2 x 6 quality control checks, level 1/2, and code chip)
  • Page 149 General Product Specifications Item Description Roche CARDIAC Control proBNP Control set for use with Roche CARDIAC proBNP+ 04890493190 (control set for 2 x 6 quality control checks, level 1/2, and code chip) Roche CARDIAC CK-MB 10 tests for quantitative detection of CK-MB...
  • Page 150 Roche representative. If you do not already have contact details, a list of Roche Diagnostics offices is provided in the appendix or visit our website at www.Roche.com. Select “Roche in your country”...
  • Page 151 Appendix 14 Appendix 14.1 Example of barcode symbologies When creating patient or operator barcodes, always adhere to the applicable international IEC/ISO standards for the respective barcode symbology. In particular, ensure that barcode size and print quality (as defined in ISO/IEC 15421) are adequate. Inadequate print size and/or quality may lead to erroneous decoding.
  • Page 152 Roche Diagnostics Canada 201 Armand-Frappier Boulevard Laval, Quebec (Canada) H7V 4A2 Technical Support for Healthcare Institutions: Region of Montreal 450-686-7111 Roche Care Center (toll free) 1-877-273-3433 www.rochediagnostics.ca Roche Diagnostics Central America Central America & The Caribbean & Edificio Capital Plaza, Piso 18...
  • Page 153 Chile Avda. Quilín 3750 Macul, Santiago Tel.: +56 (2) 4413200 China 罗氏诊断产品 （上海）有限公司 Roche Diagnostics (Shanghai) Limited 上海市淮海中路 1045 号淮海国际广场 12 楼 12/F, Huaihai Plaza, No. 1045, Central Huaihai Road Shanghai, 200031, P.R. China Tel. +86 21 2412 1000 Fax +86 21 2412 1188 Productos Roche S.A.
  • Page 154 Roche Diagnostics France 2, Avenue du Vercors, B.P. 59 38242 Meylan Cedex Tel : +33 4 76 76 30 00 www.rochediagnostics.fr Roche Diagnostics Deutschland GmbH Germany Kundenservice Center Sandhofer Straße 116 68305 Mannheim Tel.-Nr. +49 (0) 621 759 4747 Roche Diagnostics (Hellas) A.E.
  • Page 155 Roche Diagnostics Norge AS Norway Brynsengfaret 6B Pb 6610 Etterstad 0607 Oslo, Norge Tel. +47-23373300 www.roche.no Roche Diagnostics Polska Sp. z o.o. Poland ul. Wybrzeże Gdyńskie 6 B 01-531 Warszawa, Polska Tel. +48-22-481 55 55 www.roche.pl Roche Sistemas de Diagnósticos, Lda...
  • Page 156 Divizija za diagnostiko. Vodovodna cesta 109 1000 Ljubljana, Slovenija Telefon Centra za pomoč uporabnikom in servis: 080 12 32 Roche Products (Pty) Ltd. South Africa South Africa Diagnostics Division 9, Will Scarlet Road / Ferndale P.O. Box 1927, Randburg 2125 Telephone +27 -11 504-4600 Roche Diagnostics S.L.
  • Page 157 Appendix Roche Diagnostik Sistemleri Ticaret A.Ş. Turkey Gazeteciler Sitesi – Matbuat Sokak No. 3 34394 Esentepe – Istanbul Türkiye Tel: +90-212-306.06.06 Roche Diagnostics Ltd. United Kingdom Charles Avenue Burgess Hill, RH15 9RY UK Freephone: 0808 100 99 98 Rep. of Ireland Freephone: 1800 509 586 Roche International Ltd.
  • Page 158 Appendix This page intentionally left blank.
  • Page 159 Supplement for Observed Test Sequence 15 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 recommended proce- dures.
  • Page 160 Supplement for Observed Test Sequence Using the OTS function A request for an Observed Test Sequence comes from the DMS. The presence of the icon on the Patient Test button indicates a pending OTS request. Observer: Main Menu 09:15 am 1 Touch Patient Test.
  • Page 161 Supplement for Observed Test Sequence Operator: Pat. Test - OTS 09:15 am Remove Strip 1 Touch Patient Test. OTS enabled Perform the patient test as usual. Once the test is completed, the observer has to com- Observer Login Remove Strip plete the next steps.
  • Page 162 Supplement for Observed Test Sequence This page intentionally left blank.
  • Page 163 Overview ............61 Test strip guide ........143 Infections (safety instructions) ....92 Cleaning lockout ..........85 Infrared interface ........18, 132 cobas h 232 IQC lockout ............80 Contents of the pack ......10 Introduction ...........9 Operating conditions ......147 Language ............37–38 Overview of meter elements ..
  • Page 164 Index Operator lockout ........74–76 Meter setup Optional screens ........88–90 Ordering information ........148 Administrator ID ........ 62–65 Auto off ............48 Overview of meter elements ....16–18 Basics ............ 35–49 Cleaning lockout ........85 Computer ..........50–51 Patient ID ........71–72, 101–103 Contrast ..........
  • Page 165 Index Safety Protection against infection ....12 User qualification ........12 Sample material ........92, 148 Scan (button) ..........98, 103 Self-check (powering on the meter) ..96 Software license ..........150 Sound ............45–47 Specifications ..........147 Start info .............. 89 STAT Test ............
  • Page 166 Index This page intentionally left blank.
  • Page 168 ROCHE CARDIAC, COBAS, COBAS H and IQC are trademarks of Roche. Roche Diagnostics GmbH Sandhofer Strasse 116 68305 Mannheim, Germany www.roche.com www.poc.roche.com...