TECO Diagnostics Uritek TC-201 Operator's Manual
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TECO Diagnostics Uritek TC-201 Operator's Manual

Urine analyzer
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Uritek TC-201 Urine Analyzer
Operator's Manual
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Summary of Contents for TECO Diagnostics Uritek TC-201

  • Page 1 Uritek TC-201 Urine Analyzer Operator's Manual EXPORT USE ONLY...

  • Page 2: Table Of Contents

    Uritek TC-201 Urine Analyzer Operator's Manual INTRODUCTION ..............................Intended Use ............................... Getting Started ..............................Unpacking the Uritek TC-201 ........................Uritek TC-201 Hardware Overview ......................Assembling the Uritek TC-201 ........................Loading the printer roll ..........................Powering On/Off ............................Accessing the Main Menu ..........................
  • Page 3 Weekly Cleaning of Strip Bed ........................Cleaning the Analyzer Case........................Cleaning Touch Screen ..........................APPENDIX A. URITEK TC-201 ANALYZER SPECIFICATIONS ................APPENDIX B. URITEK TC-201 ANALYZER DEFAULT SETTINGS ..............APPENDIX C. URITEK TC-201 ANALYZER UNIT CONVENTION TABLE ............APPENDIX D. SYMBOLS ............................Rev. 01/2024...

  • Page 4: Introduction

    The Uritek TC-201 Urine Chemistry Test System is CLIA waived when labeled “For CLIA Waived Use” and only to be used with Teco Diagnostics Urine Reagent (URS-10) Strips. This test is waived under CLIA ’88 regulations. This test is only waived for urine specimens.

  • Page 5: Uritek Tc-201 Hardware Overview

    Uritek TC-201 Urine Analyzer Operator's Manual Uritek TC-201 Hardware Overview Uritek TC-201 consists of the following hardware components: � Touch Screen Display � Test strip bed � Printer � Power cord � Connection ports Figure 1. Uritek TC-201 1. Touch Screen Display 4.

  • Page 6: Assembling The Uritek Tc-201

    Operator's Manual Assembling the Uritek TC-201 1. Place the Uritek TC-201 analyzer on a level surface away from sources of heat and liquids. The Uritek TC-201 analyzer performs optimally between 18 – 30 °C. 2. Plug in the power supply USB-C into the back of the analyzer unit.

  • Page 7: Accessing The Main Menu

    Uritek TC-201 Urine Analyzer Operator's Manual Accessing the Main Menu After turning on Uritek TC-201 analyzer, followed by System diagnostics, Main Manu screen will appear. Figure 3. Uritek TC-201 Main Menu From the Main Menu, you may select: 1. Test Strip This will bring you to the urine sample test.

  • Page 8: Uritek Tc-201 User Interface

    Uritek TC-201 User Interface The Uritek TC-201 analyzer uses a touch screen to display user options, results, settings and diagnostics. All user input occurs via touch screen, though a barcode reader attachment may also be enabled for identifying test strip bottles (see Section 4.2 Advanced Settings).

  • Page 9: Operations

    Uritek TC-201 Urine Analyzer Operator's Manual Operations By pressing Test Strip button in the Main Menu, you can either perform a Quick Test (for use in CLIA waived settings) or a Full Test (for use in moderate complexity settings only) based on pre-set configuration.

  • Page 10: Preparing A Urinalysis Strip Quick Test

    In the meantime, press the Start button. 2. After pressing the Start button, the Uritek TC-201 starts 10 seconds of self-calibration. During this time, touch the long edge of the strip onto a paper towel to remove the excess urine and place the strip on the strip bed with the test pads facing up.

  • Page 11: Viewing The Urinalysis Strip Quick Test Result

    Uritek TC-201 Urine Analyzer Operator's Manual Viewing the Urinalysis Strip Quick Test Result 1. After the countdown ends, the analyzer displays the test result on the screen. 2. Press Results button to access the stored results or press Next Test button to perform another test.

  • Page 12: Preparing A Urinalysis Strip Full Test

    In the meantime, press the Start button. 2. After pressing the Start button, the Uritek TC-201 starts 10 seconds of self-calibration. During this time touch the long edge of the strip onto a paper towel to remove the excess urine and place the strip on the strip bed...

  • Page 13: Viewing The Urinalysis Strip Full Result

    Be sure that the test strip is inserted fully to the back of the strip bed. The dipping step should not exceed 10 seconds. 3. When calibration is completed, the Uritek TC-201 retracts the strip bed along with the strip and starts analyzing the strip.

  • Page 14: Test Results Management

    Uritek TC-201 Urine Analyzer Operator's Manual Test Result Management (For Use in both – CLIA waived and moderate complexity settings) Press the Results button on the Main Menu screen to access up to 2000 previously stored results. You may search results by ID or test Date and delete all results.
  • Page 15 Uritek TC-201 Urine Analyzer Operator's Manual 1. On Result screen, select Delete to delete all the stored test results. 2. Select Delete All and press Confirm to confirm the deletion. 3. You can select Cancel to return to the Result main menu.

  • Page 16: System Configuration

    Note: For CLIA-waived users the device will be default set for testing Teco Diagnostics URS-10 strips only 1. On Settings screen, press Strip Type button to review the current setting. The Uritek TC-201 is only compatible with Teco Diagnostics' proprietary strips.

  • Page 17: Printer Setting

    2. On Settings screen, press Restore Default Settings button to restore device settings to those preset by the manufacturer. Please see Appendix B for the default settings of Uritek TC-201 Analyzer. 3. Press Confirm to confirm the restoration.

  • Page 18: Advanced Settings

    Uritek TC-201 Urine Analyzer Operator's Manual Advanced Settings Press the Advanced button on the Main Menu screen to access the Advanced Settings menu. From this menu, it is possible to add or remove authorized operators, change operator permissions, select test mode, perform quality control testing, perform strip bed maintenance and perform system diagnostics on analyzer hardware.

  • Page 19: Test Mode

    Product Barcode Function (for use in moderate complexity settings only) The Uritek TC-201 is compatible with a barcode reader which is used to identify only Teco Diagnostics' test strip. Scan the barcode format (17)XXXXXX(10)XXXXXX, which is located on the Teco Diagnostics' test strip bottle.

  • Page 20: Quality Control

    Hence, to ensure the accuracy and performance of Uritek TC-201 Test System, quality control procedure is incorporated in the TC-201 analyzer. The purpose of including quality control procedures is to evaluate the reliability of the test system by assaying a stable quality control material that resembles patient samples.
  • Page 21 Be sure that the test strip is inserted fully to the back of the strip bed. 15. When calibration is completed, the Uritek TC-201 retracts the strip bed along with the strip and starts analyzing the strip.
  • Page 22 Uritek TC-201 Urine Analyzer Operator's Manual View and change QC Settings (for use in moderate complexity settings only) QC Prompt Setup 1. On the Advanced screen, select Quality Control. 2. On the Quality Control screen, select QC Settings. 3. Enter administrator password and press ENT to log into QC Settings screen.

  • Page 23: Device Diagnostics

    • Light Source Selecting Light Source initiates an internal check. If performing as expected, the Uritek TC-201 will display a message on the screen to notify the user that the light source is performing as expected. •...

  • Page 24: Troubleshooting

    Your Uritek TC-201 analyzer will function properly if you follow the instructions provided in this manual and maintain the instrument. If Uritek TC-201 detects a problem or an issue with the analyzer, error messages will be displayed on the LCD screen to alert the user.
  • Page 25 Uritek TC-201 Urine Analyzer Operator's Manual Use of improperly stored The user is alerted with 'Strip Quality Issue' error message and suggested strips/humidity compromised to use a new strip from unexpired bottle. strips If QC tests were performed with humidity compromised strips, then the user is alerted with the 'QC Fail' message generated after the Quality Control Test.

  • Page 26: Failure Mode Error Message And Corrective Action

    Note: If you cannot troubleshoot an error or when an error continues to occur after the corrective action is taken, please contact Teco Diagnostics Technical Support at 714-463-1111 (M-F 8am-5pm PST) or you can reach us at hello@tecodiagnostics.com.

  • Page 27: Maintenance

    (For Use in both – CLIA waived and moderate complexity settings) Careful maintenance of Uritek TC-201 analyzer is important for it to operate properly. Routine cleaning of Uritek TC-201 analyzer helps to prevent contamination and bacterial growth. It is recommended that you clean the analyzer weekly or more frequently if necessary.

  • Page 28: Cleaning The Analyzer Case

    Uritek TC-201 Urine Analyzer Operator's Manual Cleaning the analyzer case 1. Power off the analyzer. 2. Wipe the exterior plastic casing of the analyzer with a damp (not wet) cloth. 3. Dry the analyzer case with a clean cloth. Cleaning the touch screen 1.

  • Page 29: Appendix A. Uritek Tc-201 Analyzer Specifications

    Uritek TC-201 Urine Analyzer Operator's Manual Appendix A Analyzer Specifications Methodology Reflectance Photometer Calibration Method Automatic; white reflective check area Entered Parameters Urine color and clarity, operator ID, and patient ID PC Port USB, Standard RS232C Interface Ports User Interface...

  • Page 30: Appendix B. Uritek Tc-201 Analyzer Default Settings

    Uritek TC-201 Urine Analyzer Operator's Manual Appendix B. Analyzer Default Settings Date Format YYYY-MM-DD Product Barcode Enable Urine Color Disable Authorized Operator Disable Operator Access to Urine Clarity Disable Enable Strip Test Operator Access to Strip Selection Automatic Enable Recall Result...

  • Page 31: Appendix C. Uritek Tc-201 Analyzer Unit Convention Table

    Uritek TC-201 Urine Analyzer Operator's Manual Appendix C. Unit Convention Table Parameter Value (C1) Value (C2) Value (S1) Value (S2) Negative Negative Negative Negative Trace Trace Ca 15 Leu/uL Trace �� Small �� 1+ �� 1+ Ca 70 Leu/uL Leukocytes ��...
  • Page 32 Uritek TC-201 Urine Analyzer Operator's Manual Negative Negative Negative Negative Trace Trace Trace Trace �� 15 mg/dL �� 1+ �� 1.5 mmol/L �� 1+ Ketone �� 40 mg/dL �� 2+ �� 3.9 mmol/L �� 2+ �� ≥80 mg/dL �� 3+ ��...

  • Page 33: Appendix D. Symbols

    Uritek TC-201 Urine Analyzer Operator's Manual Appendix D. Symbols This section indicates the symbols that appear on the exterior packaging of the Uritek TC-201 Urine Analyzer, the analyzer itself, the power adapter and the urine reagent strips. Manufacturer European authorized representative...

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