Bayer HealthCare Clinitek Status Operator's Manual
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Bayer HealthCare Clinitek Status Operator's Manual

Bayer HealthCare Clinitek Status Operator's Manual

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Analyzer
Operator's Manual
132387 Rev. D, 2006-06

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  • Page 1 ® Analyzer Operator’s Manual 132387 Rev. D, 2006-06...
  • Page 3 Analyzer Operator’s Manual 132387 Rev. B, 2004-10...
  • Page 4 © 2003 Bayer HealthCare. All rights reserved. Clinitek, Clinitek Status, Multistix, Multistix PRO, Combistix, Uristix, Labstix, Neostix, Clinitest and Chek-Stix are trademarks of Bayer. Precept and Cidex are trademarks of Johnson & Johnson. Theracide is a trademark of Lafayette Pharmaceuticals, Inc.

  • Page 5: Table Of Contents

    Table of Contents A Brief Description ............v Understanding the Symbols and Display Icons ....vii 1 Unpacking & Set Up ..........1-1 Unpacking ..............1-1 Set Up ................1-2 Analyzer Set Up ..........1-2 Plugging Analyzer In ........1-2 Installing Batteries ..........
  • Page 6 5 Instrument Set Up ............. 5-1 Instrument Set Up ............5-1 Language Settings ............5-2 Password ..............5-3 Operator and Patient Information ........5-4 Date and Time Settings ..........5-10 Test Sequence Number ..........5-12 Instrument Settings ............. 5-13 Restore Default Settings ..........5-21 Diagnostics ..............

  • Page 7: A Brief Description

    A Brief Description What does the analyzer do? calibrates. The white calibration bar (on the test table) provides NIST ® traceable calibration. Your Clinitek Status analyzer is a portable instrument for reading ® How does it work? Bayer urinalysis strips and Clinitest immunoassay cassettes.
  • Page 8 A Brief Description How do I get results? the analyzer, use it for your daily Bayer urinalysis and Clinitest Results will be displayed on the immunoassay testing and keep it in touch screen and printed (if good working condition. desired). The results can also be transferred to a computer using a As you read through the 9-pin null modem serial cable and...

  • Page 9: Understanding The Symbols And Display Icons

    Instrument and Labeling Symbols This section describes the symbols that appear on the exterior of the Clinitek Status instrument, the power supply provided with the instrument, the carton in which the instrument was delivered and the supplies of reagent strips and cassettes which you will use with the instrument.
  • Page 10 Understanding the Symbols and Display Icons Indicates a serial port Temperature limitation (18 - 30 C) Contents sufficient for (n) tests (100) Use by YYYY-MM Catalog number Serial number Batch code Biohazard Indicates that this equipment is classified as Waste Electrical and Electronic Equipment under the European WEEE Directive.
  • Page 11 Understanding the Symbols and Display Icons Keep dry Keep away from sunlight and heat VDE Testing and Certification Institute - Germany Manufacturer’s mark (FRIWO) and manufacturing location (Hong Kong) Manufacturer’s mark (FRIWO) and manufacturing location (Geratebau, Germany) Encapsulated safety isolating transformer (short-circuit proof) Positive Temperature Coefficient (PTC) - A thermistor device used to protect the transformer from short-circuits or overload.
  • Page 12 Understanding the Symbols and Display Icons Display Icons The Bayer logo is shown in the top left of the display while some of the system diagnostic tests are being carried out after power-up. There are seven other icons which display in the same position to show the mode of the instrument.

  • Page 13: Unpacking & Set Up

    Check the and check for the following items: carton and instrument for visible signs of damage; if seen, immediately contact the carrier. Appendix A, Local Technical Support Clinitek Status ® analyzer Providers and Distributors). Test table Paper Roll Do not touch the white calibration bar.

  • Page 14: Set Up

    Plugging Analyzer In Plug the appropriate end of the power cord into the power inlet socket located on the rear of the Clinitek Status analyzer. Plug the other end of the power cord into an AC electrical wall outlet. Installing Batteries...

  • Page 15: Inserting Test Strip Table

    Unpacking & Set Up Set Up Inserting Test Strip Table Insert the test strip table into the analyzer by holding it by the end opposite the white calibration bar and with the white bar facing up. Push the test table into the analyzer, pushing it in just over halfway.

  • Page 16: Analyzer Software Upgrades

    Unpacking & Set Up Analyzer Software Upgrades Analyzer Software Upgrades From time to time Bayer HealthCare will add new features and make improvements to the Clinitek Status instrument software. These software updates will be available on an electronic memory card which is inserted into the software update socket.

  • Page 17: Loading The Printer Paper Or Label Roll

    Unpacking & Set Up Set Up Loading the Printer Paper or Label Roll 1. Open the printer cover by pulling up on the tab. 2. Open the paper roll compartment cover by pressing down on its tab and pulling out. 3.

  • Page 18: Warranty Registration

    Unpacking & Set Up Set Up Warranty Registration 1. Lift the printer cover on the instrument and the serial plate with the instrument’s serial number will be visible. 2. Write the serial number and installation date on the Warranty Registration Card. After the instrument has been successfully installed, complete the information on the Warranty Registration Card...

  • Page 19: Powering Up

    Unpacking & Set Up Powering Up Powering Up Press the on/off button located on the front of the instrument. This is the first screen displayed. The analyzer will run an automatic system diagnostic test each time it is turned on. If this is the first time you have turned on the analyzer, you will be led through a Start-Up Wizard, a...

  • Page 20: Powering Down

    Unpacking & Set Up Powering Down Powering Down 1. Before turning the analyzer off, always ensure that there is no strip or cassette on the test table and that the table and insert are clean. 2. Press the on/off button at least 2 seconds.

  • Page 21: Screens

    Interacting with the Touch Screen Screens Screens The touch screen will guide you through the operation of the ® Clinitek Status analyzer. The screen will display messages, instructions and options to which you respond by touching the appropriate area on the screen.
  • Page 22 Interacting with the Touch Screen Screens How to Touch the Screens If a touched area does not The screen needs to be touched respond as expected, slide your lightly in the touch-sensitive area to finger across the appropriate activate a response. selection area.
  • Page 23 Interacting with the Touch Screen Screens Boxed Areas These are areas on the screen enclosed in boxes. Simply touch any area within the box to activate that function. The boxed areas vary in size. The boxes located on the main Select screen are examples of larger areas.

  • Page 24: Keyboards

    Interacting with the Touch Screen Keyboards Keyboards Press to switch to numeric keyboard Using the Alpha-Numeric Back Space/ Keyboard Data Entry Box Erase key When the screen prompts you to enter information for Operator ID, Patient’s Name and/or Patient Identification, a keyboard will appear on the screen.
  • Page 25 Interacting with the Touch Screen Keyboards The maximum number of characters allowed is 20. An audible tone will sound when you have exceeded the maximum number of characters. Once you have finished entering the information, touch Enter (from either keyboard screen). 132387 Rev.
  • Page 26 Interacting with the Touch Screen 132387 Rev. B, 2004-10...

  • Page 27: Start-Up Wizard

    Start-Up Wizard The first time your Clinitek Status ® analyzer is turned on (following an automatic system diagnostic test), it will take you through a quick set up procedure. This procedure will allow you to select the basic functions of the analyzer so you can use the analyzer with your choice of settings.
  • Page 28 Start-Up Wizard 132387 Rev. B, 2004-10...

  • Page 29: Testing

    Testing Quick Tests Quick Tests Urinalysis Strip Test BIOHAZARD Wear personal protective equipment. Use universal precautions. Refer to Appendix H for recommended precautions when working with biohazardous materials. Testing is started from the main Select screen. If you require more information regarding use and storage of test strips, please refer to the strip package insert.
  • Page 30 Testing Quick Tests The next screen that appears is another Prepare Test. This screen prompts you through the steps to prepare the test strip. A timer displays how much time you have remaining to complete the steps. You have 8 seconds to complete the following four steps: Dip the reagent strip into the urine sample, wetting all pads.
  • Page 31 Do not push or pull the test table. ® The Clinitek Status analyzer will perform an automatic calibration each time a test is run. Be sure not to move or bump the table while the instrument is calibrating.
  • Page 32 Testing Quick Tests The Analyzing screen will be displayed when the calibration has been completed and the analysis of the strip has begun. A timer will count down the time remaining in analyzing the strip results. If the analyzer has been set up to automatically print the results, then the Printing screen will be displayed until the print out has...
  • Page 33 Testing Quick Tests The next screen displayed is the Results screen. The first page of the test results are displayed on the screen and the test table and strip are automatically pushed out of the analyzer. To view the remaining test results, touch More on the screen.

  • Page 34: Cassette Test

    Testing Quick Tests Cassette Test BIOHAZARD Wear personal protective equipment. Use universal precautions. Refer to Appendix H for recommended precautions when working with biohazardous materials. Testing is started from the main Select screen. ® Please refer to the Clinitest cassette test package insert for more information regarding use and storage of test cassettes.
  • Page 35 Testing Quick Tests Make sure the test table insert is in position for a cassette test. Remove the test cassette from the foil package and place the cassette on the test table. Once you touch the START button you have 8 seconds to draw the urine sample into the pipette and add the urine sample into the well on the cassette.
  • Page 36 Testing Quick Tests You have 8 seconds to complete the following two steps: Draw the urine sample to the line marked on the pipette (approximately 0.2 mL). Add entire contents of the pipette into the sample well of the test cassette. At the end of the 8 second countdown, the test table and cassette will automatically be pulled...
  • Page 37 Testing Quick Tests The Clinitek Status analyzer will perform an automatic calibration each time a test is run. Be sure not to move or bump the table while the instrument is calibrating. The Analyzing screen will be displayed when the calibration has been completed and the analysis of the cassette has begun.
  • Page 38 Testing Quick Tests If the analyzer has been set up to automatically print the results, the Printing screen will be displayed until the print out has been completed (otherwise the Results screen will appear). The date, time and test sequence number will be printed along with the test results.

  • Page 39: Full Tests

    Testing Full Tests Full Tests Urinalysis Strip Test BIOHAZARD Wear personal protective equipment. Use universal precautions. Refer to Appendix H for recommended precautions when working with biohazardous materials. A Full Strip Test allows you the option to enter an Operator ID, Patient Name and/or Patient ID prior to inserting a strip.
  • Page 40 Testing Full Tests The next screen that appears is Operator ID. There are two options under Operator ID: Last Operator or Enter New Operator ID. Option 1: Last Operator If this option is enabled, the last operator that entered his/her ID will be displayed on the screen in the lower right side of the box.
  • Page 41 Testing Full Tests The next screen displayed is Patient Information. There are two options under Patient Information: Recall Patient or Enter New Patient. Option 1: Recall Patient In order to look up previous patients, touch Recall Patient. If previous patient identification has been entered, a list of up to 200 patient results will appear on the screen.
  • Page 42 Testing Full Tests Option 2: Enter New Patient In order to enter the information for a new patient, touch Enter New Patient button. The next screen displayed is Enter Patient Name. Use the keyboards to enter Patient Name using a maximum of 20 characters.
  • Page 43 Testing Full Tests The next screen displayed is Patient Identification. Use the keyboards to enter Patient Identification using a maximum of 13 characters. Touch Enter when you have finished entering the patient’s ID and to proceed to the next screen. If you require further instruction regarding keyboard usage see Section 2, Interacting with the Touch...
  • Page 44 Testing Full Tests The next screen that appears is Prepare Test. If you require further instruction regarding the procedures for running a Bayer urinalysis strip test see Section 4, Quick Tests. While the strip is being analyzed, a Select Appearance screen will be displayed.
  • Page 45 Testing Full Tests Select the clarity by touching the circle that corresponds to the correct description. Then touch Next. There is a time indicator on the Select Appearance screen that is counting down the time remaining in the analysis of the strip. After color and clarity have been entered the next screen displayed will either be:...
  • Page 46 Testing Full Tests The test results displayed on the screen and the printout will include the following information: Patient Name, ID or both Type of strip used Test date Time Operator Test Number Color Clarity Results If the results are positive, an asterisk* will appear next to the results (if “mark positive results”...

  • Page 47: Cassette Test

    Testing Full Tests Cassette TestsCassette Test BIOHAZARD Wear personal protective equipment. Use universal precautions. Refer to Appendix H for recommended precautions when working with biohazardous materials. A Full Cassette Test allows you the option to enter an Operator ID, Patient Name and/or Patient ID prior to inserting a cassette.
  • Page 48 Testing Full Tests Option 1: Last Operator If this option is enabled, the last operator that entered his/her ID will be displayed on the screen in the lower right side of the box. If you are this operator, then touch the Last Operator button to proceed.
  • Page 49 Testing Full Tests Option 1: Recall Patient In order to look up previous patients, touch Recall Patient. If the previous patient identification has been entered, a list of up to 200 patients will appear on the screen. Use the up and down arrow buttons to scroll through the list of patients.
  • Page 50 Testing Full Tests Option 2: Enter New Patient In order to enter the information for a new patient, touch the Enter New Patient button. The next screen displayed is Enter Patient Name. Use the keyboards to enter Patient Name using a maximum of 20 characters.
  • Page 51 Testing Full Tests The next screen displayed is Enter Patient ID. Use the keyboards to enter Patient Identification using a maximum of 13 characters. Touch Enter when you have finished entering the patient’s ID and are ready to proceed to the next screen.
  • Page 52 Testing Full Tests The next screen that appears is Test Type. If you require further instruction regarding the procedures for running a Clinitest hCG cassette test see Section 4, Quick Tests. The test results displayed on the screen and the printout will include the following information: Patient Name, ID or both Type of Clinitest cassette test...

  • Page 53: Instrument Set Up

    Instrument Set Up Instrument Set Up Instrument Set Up Your Clinitek Status ® analyzer allows you to change settings to suit your workplace requirements. If no customizing is desired, the analyzer will automatically be programmed with default settings (to view default settings please see Appendix D: Instrument Default Settings).

  • Page 54: Language Settings

    Instrument Set Up Language Settings Language Settings Use the up and down arrows to scroll through the list of languages. Touch Select when you have highlighted the desired language. Before changing the language an alert screen will be displayed requesting you to confirm your decision.

  • Page 55: Password

    Instrument Set Up Password Password When a password has been set, no changes can be made to the Instrument Set Up until the password has been entered. Set Password Enter a password into the data entry box using the alphabetic and/ or numeric keyboards (maximum 12 characters).

  • Page 56: Operator And Patient Information

    Instrument Set Up Operator and Patient Information Operator and Patient Information Selecting this option will allow you to choose display options for data entry. The Input Settings screen allows you to select 1 of 3 test sequences. Quick Test A test without any operator or patient information required.
  • Page 57 Instrument Set Up Operator and Patient Information On the Input Settings screen, touch a round button in the box of the preferred test sequence. Then touch Next for test sequence confirmation. Touch Done on the Input Settings screen to return to the Choose Settings screen.
  • Page 58 Instrument Set Up Operator and Patient Information Custom Settings Touch the round button in the Custom Set Up box to customize selections for data entry. Touch Next. The next 5 screens present choices for customizing your testing. Choose settings by touching and highlighting a round button for each category.
  • Page 59 Instrument Set Up Operator and Patient Information Screen 2 of 5 Patient Name – allows you to choose whether patient name will be required for running a test – Enabled (on) or Disabled (off). Patient ID – allows you to choose whether Patient ID will be required for running a test –...
  • Page 60 Instrument Set Up Operator and Patient Information Screen 4 of 5 Choose which to record during a strip test – allows you to select which sample details you would like to be recorded during a strip test – Color and Clarity, Color only, Clarity only or None (no sample information).
  • Page 61 Instrument Set Up Operator and Patient Information Touch the round button next to Enabled (on) to highlight and activate this custom setting. Touch the round button next to Disabled (off) to deactivate the custom setting. Touch Previous to scroll back through custom setting screens to review.

  • Page 62: Date And Time Settings

    Instrument Set Up Date and Time Settings Date and Time Settings The date and time are displayed on the Select screen and are recorded with test results. The format of the date and time are displayed along with specific date and time values.
  • Page 63 Instrument Set Up Date and Time Settings The AM and PM selections will not be available if the time is in the 24-hour format. The Set Date & Time display will show the date and time in the formats selected. Select Set to confirm your choices and return to the Choose Settings screen.

  • Page 64: Test Sequence Number

    Instrument Set Up Test Sequence Number Test Sequence Number The test sequence numbers run from 0001 to 9999 and can be reset. The screen shows the next test number. Touch the Reset to 0001 round button if you would like to reset the numbers to start at 0001 for the next test.

  • Page 65: Instrument Settings

    Instrument Set Up Instrument Settings Instrument Settings This section has a series of screens which control the way in which the Clinitek Status analyzer displays information and operates. There are 5 Instrument Setting items. Results Format System Settings Display Contrast...
  • Page 66 Instrument Set Up Instrument Settings Plus System – select Enabled (on) if you wish to have results shown in the Plus System. You will also see in Appendix B that results can be recorded in the Plus System (which uses “+” symbols) instead of clinical units such as mg/dL (mmol/L).
  • Page 67 Instrument Set Up Instrument Settings System Settings This allows selections regarding the printer, power and sound. System Settings Screen 1 of 2 Printer – allows you to select the preferred printing option by touching the round button. Automatic – Results for each test will be printed automatically when the test is complete.
  • Page 68 Instrument Set Up Instrument Settings Screen 2 of 2 Sound – allows you to adjust the sound by highlighting and selecting a level. Sound on – The instrument will use a range of audible tones. Sound off – No audible tones will be made by the instrument.
  • Page 69 Instrument Set Up Instrument Settings Connectivity This allows you to choose connectivity settings. Allow results to be sent to PC This allows the instrument to transfer patient results to a host computer. If this function is not required, touch Done to return to Instrument Settings screen.
  • Page 70 Touch round button of either Yes or No depending on whether you choose to include the serial number of your Clinitek Status analyzer as part of the patient results sent to the computer. If you have enabled the upload...
  • Page 71 Stop Bits – Touch a round button to select the number of Stop Bits. Select Urinalysis Test This displays a list of some of the Bayer urinalysis strips which can be used with the Clinitek Status analyzer. 5-19 132387 Rev. B, 2004-10...
  • Page 72 Instrument Set Up Instrument Settings Use the up and down arrows to scroll through the list until the type of strip you want to use is highlighted. Touch Select to confirm and return to the Instrument Settings screen. Do not use any reagent strip product other than what is shown on the display.

  • Page 73: Restore Default Settings

    Instrument Set Up Restore Default Settings Restore Default Settings This option lists the analyzer’s original settings. Use the up and down arrows to view the default settings. Touch Restore in order to return the analyzer to the settings listed. Touch Yes to confirm your decision or No to maintain the current settings of your analyzer.

  • Page 74: Diagnostics

    Instrument Set Up Diagnostics Diagnostics This option lists 7 diagnostic tests which can be conducted. Display Touch Screen Printer Test Table Light Source Electronics Check Cassette These diagnostics tests should only be conducted when instructed by a Bayer Customer Service representative. The representative will lead you through the test procedures (see Appendix A for Local Technical...

  • Page 75: System Information

    Instrument Set Up System Information System Information This screen has information about your analyzer. Touch System Configuration to view details of the current system configuration. This screen will show the current settings for all the items which can be changed within the Input Settings and Instrument Settings screens.
  • Page 76 Instrument Set Up System Information This completes the settings and choices within Instrument Set Up. Touch Done to return to the main Select screen. 5-24 132387 Rev. B, 2004-10...

  • Page 77: Recall Results

    Recall Results Patient Results Patient Results In order to look up a patient’s results, return to the main Select screen. Touch Recall Results button. The next screen displayed is Select Test Results. The test results are in chronological order. The most recent test result is displayed at the top of the screen and is highlighted.
  • Page 78 Recall Results Patient Results The first page of the patient’s results is displayed on the screen. If more than one page of results exists for the patient, then the More button will be present on the screen. If you would like to print the results, touch the Print button.

  • Page 79: Sending Data To A Pc

    Recall Results Sending Data to a PC Sending Data to a PC To send data to a computer; if a computer has been connected to the analyzer, all results can be sent to the computer by touching the Send all data button.
  • Page 80 Recall Results 132387 Rev. B, 2004-10...

  • Page 81: Troubleshooting

    If more than one of this Error messages will be displayed to class of error occurs, clearing one help you when the Clinitek Status message will enable the next to be analyzer detects something which displayed in order of importance to needs your attention.
  • Page 82 Troubleshooting Battery Power Icon Dashes may appear next to Color and Clarity on test result printouts. This occurs when the instrument is powered by batteries. Color and The battery icon indicates the Clarity are selected in the power level of the battery. Power Instrument Set Up, but no can be reduced while testing selections have been recorded on...
  • Page 83 Troubleshooting Calling for Assistance For customer support, please If your Clinitek Status analyzer is contact your local technical support displaying corrective actions for a provider or distributor (for contact detected problem, please carry out information please see Appendix A, the displayed instructions before Local Technical Support Providers calling for assistance.

  • Page 84: List Of Errors And Advisory Messages

    Troubleshooting Lists of Errors and Advisory Messages Clinitek Status Analyzer: List of Errors and Advisory Messages Error Code Description Action Low battery power Replace the batteries: a) To view instructions on the display, touch the Error Report selection area, or b) To use the instructions in this manual, see page 9-7, Changing Batteries.
  • Page 85 Troubleshooting Lists of Errors and Advisory Messages Error Code Description Action Printer error Lift the printer cover and push the paper holding arm back into position (see page 1-5, Loading the Printer Paper or Label Roll for location of paper holding arm). Ensure that the strip type selected in Incorrect strip type Instrument Set Up is being used (see 5-19...
  • Page 86 Troubleshooting Lists of Errors and Advisory Messages Error Code Description Action Tilted strip Repeat the test ensuring that the strip is correctly positioned on the test table (see page 4-3). Repeat the test ensuring that the strip has been Dry strip in contact with the sample (see page 4-2).
  • Page 87 Troubleshooting Lists of Errors and Advisory Messages Error Code Description Action E03, E04, Failure of Contact your local Bayer Customer Service E05, E06, computer software and Support Center (contact information is E07, E08, given in Appendix A). E21, E22, E90, E91, E92 or E93 132387 Rev.

  • Page 88: Problem Checklist

    Troubleshooting Problem Checklist Problem Checklist Clinitek Status Analyzer: Serial Number ___________________________ Installation Date___________________________ 1. Have you reviewed the error messages on pages 7-4 to 7-7? 2. Please record any error messages that have been displayed: ________________________________________________________________ ________________________________________________________________ ________________________________________________________________ 3. Does the test table move out to the “load” position when the analyzer is first turned on? 4.
  • Page 89 Troubleshooting Problem Checklist 8. Is the name of the Bayer urinalysis strip or Clinitest immunoassay cassette shown on the display the same as the product being used? 9. Does the display or printout show the correct test names and expected results? 10.
  • Page 90 Troubleshooting 7-10 132387 Rev. B, 2004-10...

  • Page 91: Quality Control Testing

    Quality Control Testing Quality Control Testing The Clinitek Status system is CLIA waived only when used with Bayer branded urinalysis reagent strips. For CLIA waived settings, we recommend that a quality control test be performed with each new reagent bottle opened.

  • Page 92: Information Regarding Clia Waiver

    Quality Control Testing Information regarding CLIA Waiver The Clinitek Status system is CLIA waived for all Bayer branded urinalysis reagent strips. Cassette testing is currently categorized as moderate complexity. Failure to adhere to the instructions for use, including instructions for...

  • Page 93: Cleaning And Maintenance

    Cleaning and Maintenance Cleaning Cleaning The test table insert and the test table should be kept clean if the analyzer is to operate properly. Do not autoclave the test table or test table insert. BIOHAZARD Wear personal protective equipment. Use universal precautions. Refer to Appendix H for recommended precautions when working with biohazardous materials.
  • Page 94 Cleaning and Maintenance Cleaning Dry the test table thoroughly (except for the white calibration bar) with a soft cloth or lint-free tissue. Care should be taken not to scratch the white calibration bar. Instructions for cleaning the white calibration bar are given later in this section.
  • Page 95 Cleaning and Maintenance Cleaning Disinfecting the Test Table and Place the insert and/or test Insert table into the solution, making sure the white calibration bar on Prepare one of the following the test table remains above solutions in a tall, narrow the liquid level.
  • Page 96 Cleaning and Maintenance Cleaning ® To enable your Clinitek Status analyzer to perform as intended and provide reliable test results, it is recommended that you periodically check the white calibration bar on the test table. In normal use, the white calibration bar should not become dirty or discolored.
  • Page 97 Cleaning and Maintenance Cleaning If the white calibration bar is clean and unmarked, replace the table into the analyzer by holding the table at the end opposite the white calibration bar, with the white calibration bar facing upwards. Push the test table firmly but slowly, just over half way into the analyzer.
  • Page 98 Cleaning and Maintenance Cleaning Always keep the outside of the Clinitek Status analyzer clean and free of dust. BIOHAZARD Wear personal protective equipment. Use universal precautions. Refer to Appendix H for recommended precautions when working with biohazardous materials. Turn the analyzer off by pressing the on/off button for 2 seconds.

  • Page 99: Changing Batteries

    Cleaning and Maintenance Changing Batteries Changing Batteries Battery-Powered Operation The Clinitek Status analyzer is designed to let you carry out the maximum number of tests (approximately 100) from a set of batteries. To achieve this, the Power Save feature is always activated when the instrument is powered by batteries.
  • Page 100 Cleaning and Maintenance Changing Batteries Remove the test table from the analyzer. Next, place the analyzer on its side and remove the battery cover by pressing down on the tab and pulling out. Remove current batteries. Place 6 new AA-size batteries into the analyzer.

  • Page 101: Appendices

    Produtos Diagnósticos Sudbury, CO10 2XQ, UK Rua Domingos Jorge 1100 04779-900 – São Paulo – SP Brazil +55-11-5694-5166 Bayer HealthCare LLC Subsidiary of Bayer Corporation Tarrytown, NY 10591-5097 USA Bayer Inc. 77 Belfield Road Bayer Diagnostics Mfg (Sudbury) Ltd Toronto, Ontario...
  • Page 102 Appendices Appendix A: Local Technical Support Providers and Distributors Bayer HealthCare - Diagnostics Divisione Diagnostici Nørgaardsvej 32 Via Grosio 10/4 DK-2800 Kgs. Lyngby, Denmark 20151 Milano, Italia +45-45-23-50-00 +39-2-3978-1 Bayer OY Bayer Medical Ltd. Suomalaistentie 7 Marunouchi Kitaguchi Building FIN 02270 Espoo, Finland...
  • Page 103 Bayer Diagnostics Europe Ltd United Kingdom (sucursal em Portugal) +44 (0) 1635-563000 Rua Quinta do Pinheiro, 5 2795-653 Carnaxide, Portugal Bayer HealthCare LLC +351-21-416-4227 Subsidiary of Bayer Corporation 511 Benedict Avenue Bayer Puerto Rico Inc. Tarrytown, NY 10591-5097 USA Diagnostics Division...

  • Page 104: Appendix B: Tables Of Results

    Appendices Appendix B: Tables of Results Appendix B: Tables of Results Table 1 English – Conv. Units – Conventional Reagent Strip Tests Test Abbreviation Units Reported Results Normal System Plus System Glucose Negative Negative mg/dL >=1000 Trace Bilirubin Negative Moderate Negative Small Large...
  • Page 105 Appendices Appendix B: Tables of Results Test Abbreviation Units Reported Results Normal System Plus System Protein: Normal Creatinine Dilute Abnormal Multistix PRO Normal >500 mg/g No Difference Abnormal Abnormal Cassette Test Test Abbreviation Reported Results Normal System Plus System Human Chorionic hCG Negative hCG Positive Gonadotropin...
  • Page 106 Appendices Appendix B: Tables of Results Table 2 English – S.I. Units – International (S.I.) Reagent Strip Tests Test Abbreviation Units Reported Results Normal System Plus System Glucose Negative Negative mmol/L >=55 Trace Bilirubin Negative Moderate Negative Small Large Ketone Negative Negative mmol/L...
  • Page 107 Appendices Appendix B: Tables of Results Test Reported Results Abbreviation Units Normal System Plus System Protein: Normal Dilute 33.9 Creatinine Abnormal Multistix PRO Normal >56.6 mg/mmol No Difference Abnormal 17.0 Abnormal 33.9 Abnormal Cassette Test Test Abbreviation Reported Results Normal System Plus System Human Chorionic hCG Negative...
  • Page 108 Appendices Appendix B: Tables of Results Table 3 English – Nordic Units – Nordic Plus System Reagent Strip Tests Test Abbreviation Units Reported Results Normal System Plus System Glucose Negative Negative Trace Bilirubin Negative No Difference Ketone Negative Negative Trace Specific <=1.005 1.020...
  • Page 109 Appendices Appendix B: Tables of Results Cassette Test Test Abbreviation Reported Results Normal System Plus System Human Chorionic hCG Negative hCG Positive Gonadotropin No Difference hCG Borderline Repeat in 48-72 hours The results shown in shaded areas will be marked as positives, if “mark positive results”...

  • Page 110: Appendix C: Specifications

    200 Patient details (Patient’s Name Range and/or Patient Identification) 18°C to 30°C (64°F to 86°F) Safety Standards Ambient Operating Humidity The Clinitek Status analyzer is Range classed as a Class A computing 18% to 80% Relative Humidity device in accordance with Part 15 (non-condensing) of FCC Rules.
  • Page 111 Appendices Appendix C: Specifications NOTE: This equipment has been The instrument is certified as tested and found to comply with the meeting the EMC requirements and limits for a Class A digital device, safety specifications of the In Vitro pursuant to Part 15 of the FCC Diagnostic Directive Rules.

  • Page 112: Appendix D: Instrument Default Settings - English

    Appendices Appendix D: Instrument Default Settings – English Appendix D: Instrument Default Settings – English Time Format Password 12 hour Password protection not set Results Format Input Settings Units Selection Quick Test Conventional Operator ID Plus System Disabled Disabled Keyboard Priority Mark Positive Results Alphabetic Disabled...
  • Page 113 Appendices Appendix D: Instrument Default Settings – English Baud Rate 115200 Parity None Stop Bits 1 (one) Urinalysis Test Selected ® Multistix 10 SG 10-13 132387 Rev. A, 2003-07...

  • Page 114: Appendix E: System Overview & Principles

    Appendix E: System Overview & Principles Appendix E: System Overview & Principles Intended Use of Analyzer Light from the LEDs travels along The Clinitek Status ® analyzer is for the light guide and is reflected off in vitro diagnostic use in: the calibration bar, strip or cassette onto the mirror.
  • Page 115 Appendices Appendix E: System Overview & Principles always form whereas the test line Each time a cassette is read, the will only form if hCG is present in instrument positions the table the sample. correctly and checks the electronics and signals. It then takes reference Description of Internal Checks readings of the white calibration bar When the analyzer is first turned...
  • Page 116 Appendices Appendix E: System Overview & Principles instrument optics are capable of detecting certain colors that are masked by or blended with other colors to the human eye. For this reason, exact agreement between visual results and instrument results might not be found.
  • Page 117 Appendices Appendix E: System Overview & Principles 10-17 132387 Rev. A, 2003-07...
  • Page 118 Appendices Appendix E: System Overview & Principles 10-18 132387 Rev. B, 2004-10...
  • Page 119 Appendices Appendix E: System Overview & Principles 10-19 132387 Rev. B, 2004-10...
  • Page 120 Appendices Appendix E: System Overview & Principles 10-20 132387 Rev. B, 2004-10...

  • Page 121: Appendix F: Clia Waiver Performance Characteristics

    Appendices Appendix F: CLIA Waiver Performance Characteristics The Clinitek Status received CLIA waiver status (42 CFR 493) for the entire urinalysis menu in 2005. Clinitek Microalbumin required a separate CLIA Waiver submission for use on the Clinitek Status. All additional tests using new urinalysis chemistries or new immunoassay analytes will require Clinitek Status system CLIA Waiver approval.
  • Page 122 The following analyte test results were derived from a Physician Office Laboratory (POL) study conducted at 3 POL sites and 1 clinical laboratory site. The performance of the Clinitek Status analyzer and Multistix reagent for these analytes met the primary performance criteria that 90% of the results should be within +/- one level of the expected result.

  • Page 123: Appendix G: Training & Educational Materials

    Appendices Appendix G: Training & Educational Materials ® Chek-Stix Positive and Negative control strips are available for use in your training program for routine urine strip testing (for supply information see Appendix A, Local Technical Support Providers and Distributors). Follow the package insert for instruction on preparation and testing.

  • Page 124: Appendix H: Safety Information

    Appendices Appendix H: Safety Information Protecting Yourself from direct contact with superficial Biohazards cuts, open wounds, and other skin conditions that This information summarizes the may permit absorption into established guidelines for handling subcutaneous skin layers laboratory biohazards. This splashes or aerosol contact summary is based on the with skin and eyes guidelines developed by the...
  • Page 125 Appendices Appendix H: Safety Information Keep your hands away from References your face. 1. Centers for Disease Control. Cover all superficial cuts and Update: Universal precautions for wounds before starting any prevention of transmission of work. human immunodeficiency virus, Dispose of contaminated hepatitis B virus and other materials according to your bloodborne pathogens in...
  • Page 126 Appendices 10-26 132387 Rev. D, 2006-06...
  • Page 127 5-16 Calibration, 4-3, 4-9 icons, vii - x error messages, 7-4, 7-6 time outs, 4-5, 4-10 Cassette ® Clinitek Status Check cassette, full test, 4-19 to 4-24 Electrical outlet, 5-15 immunoassay cassette, 4-7, 4-8 Error(s) preparing a cassette, 4-7...
  • Page 128 Index Full test Language cassette test, 4-19 to 4-24 select language, 5-2 set up, 5-4 strip test, 4-11 to 4-18 Mark positive results, 5-14 General information, 7-1H Help cassette test, 4-6 strip test, 4-1 Operator last operator identification, 4-12, 4-19 new operator identification, 4-12, 4-19 Icons...
  • Page 129 Index Power inlet socket, 1-2 Reagent on/off button, 1-7, 1-8 select strip product, 5-20 plugging analyzer in, 1-2 Results save, 5-15 amount of time results displayed supply, 1-1, 1-2 on screen, 4-5, 4-10 Power save choose results format, 5-13 to electrical outlet, 5-15 5-14 batteries, 5-15...
  • Page 130 Index Strip blot strip, 4-3 Units changing strip type, 5-19 conventional units, 5-13 dip strip, 4-2 nordic units, 5-13 full strip test, 4-11 to 4-18 SI units, 5-13 holding channel, 4-3 Unpacking, 1-1 preparing a urine strip, 4-2 Urinalysis test selection, 5-19, quick strip test, 4-1 to 4-5 5-20 select strip type, 5-20...

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