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Siemens Healthineers CLINITEK Status Connector User Manual

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CLINITEK Status®
Connector

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Summary of Contents for Siemens Healthineers CLINITEK Status Connector

  • Page 1 CLINITEK Status® Connector...
  • Page 2 If the system is used in a manner differently than specified by Siemens Healthcare Diagnostics, the protection provided by the equipment may be impaired. See warning and hazard statements. Siemens Healthineers Origin GB for: Siemens Healthcare Diagnostics Siemens Healthcare Diagnostics Inc.
  • Page 3 CLINITEK Status® Connector User Guide...

  • Page 5: Table Of Contents

    Contents Chapter 1 Introduction Chapter 5 Troubleshooting About this guide Overview Recording the Warranty Information Intended use Key features Support Information Orderable Supplies What’s in the box Getting to know the Connector Appendix A Specifications and Symbols Setting up the Connector Overview User interface Connector Specifications...

  • Page 7: Chapter 1 Introduction

    Chapter 1 Introduction...

  • Page 8: About This Guide

    ‒ Communication through the Ethernet or a about setting up and using functionality wireless connection provided by the CLINITEK Status Connector. For complete information about using the CLINITEK Wireless only available in certain regions. Status+ analyzer, see the CLINITEK Status+ Contact your Siemens Healthineers Analyzer Operator’s Guide.

  • Page 9: Getting To Know The Connector

    Getting to know the Connector The electromagnetic environment should be evaluated prior to operation of the The CLINITEK Status Connector connects to device. Do not use this device in close the CLINITEK Status+ analyzer by attaching proximity to sources of strong the units and connecting them with two short electromagnetic radiation (e.g.,...

  • Page 10: Using The Start-Up Wizard

    Select. If you do not run your analyzer with a connector, Siemens Healthineers 2. Tap Next. recommends setting the connector to the 3. On the Set Date & Time screen, use the Disabled setting.

  • Page 11: User Interface

    Chapter 1 - Introduction User interface the list of information on the left side of the screen. After the information on the left side of the screen is highlighted, select The CLINITEK Status+ analyzer and connector the appropriate button at the bottom of system provides an easy-to-navigate user the screen.
  • Page 12 Chapter 1 - Introduction...

  • Page 13: Chapter 2 Basic Operations

    Chapter 2 Basic Operations...

  • Page 14: Material Provided

    Chapter 2 - Basic Operations Material Provided Working with Authorized Operators CLINITEK Status Connector This section describes how to set up use of operator IDs and add, edit, or delete the list of operator IDs. The CLINITEK Status+ analyzer Special Materials Required (Not stores 700 operators.
  • Page 15 Chapter 2 - Basic Operations 16. On the Authorized Operator-Operators INSTRUCTIONS list screen, tap Exit. 1. On the Select Ready screen, tap Instrument Set Up. 17. Tap Done 3 times to return to the Select Ready screen. 2. On the Choose Settings screen, use the arrow keys and select Instrument Settings.

  • Page 16: Requiring Scanning Of Patient Information

    Chapter 2 - Basic Operations ‒ Tap Yes to delete the operator and return 3. Tap Select. to the Authorized operator screen. 4. On the Instrument Settings screen, use the ‒ Tap No to return to display the operator arrow keys to select Barcode Settings. details, then tap Done to return to the 5.

  • Page 17: Managing Urine Colors

    Chapter 2 - Basic Operations but barcode label 12345678 would be 5. To navigate to the Sample Appearance- rejected. Select Colors screen: Note: User-defined barcodes for Operator ‒ Tap Next. ID and Patient ID have a 13-character limit. ‒ Tap Next 3 times. ‒...

  • Page 18: Managing The Strip Lot Number And Expiration Date

    Chapter 2 - Basic Operations 7. On the Sample Appearance-Select colors 3. Tap Next. screen 3 of 3, tap Enter custom color 1 The Select Appearance-Test in progress (2, 3, or 4) corresponding to each custom screen 3 of 4 displays. color.

  • Page 19: Entering The Strip Lot Number And Expiration Date

    Chapter 2 - Basic Operations Working with data 6. On the Urinalysis Test Settings screen, you can choose to use the last lot number A CLINITEK Status+ analyzer may contain up to and expiration date: 700 patient test and 200 QC test results, and ‒...
  • Page 20 Chapter 2 - Basic Operations 10. Tap Search. The Recall Results-Search Results screen displays. 11. To view or print the retrieved records, follow these steps: ‒ To print all the records retrieved, tap Print all. Printing all the records may take a long time.

  • Page 21: Chapter 3 Working With Quality Control

    Chapter 3 Working with Quality Control...

  • Page 22: About Qc Tests

    Chapter 3 - Working with Quality Control Overview ‒ Set the instrument to allow patient tests when a reminder QC is due. Quality Control (QC) testing helps assure that ‒ Set the instrument to lock out testing any the reagent strips and cassettes are reacting patient sample until all QC control results correctly and that the instrument is accurately are within the acceptable range.

  • Page 23: Setting Up Qc Strip Tests

    Chapter 3 - Working with Quality Control ‒ Tap Enabled for Enter lot number and 5. Choose a QC pass or fail option: expiration date before each test feature. ‒ To have the instrument determine QC pass ‒ Tap Enabled for Use last lot number and or fail, tap Instrument.
  • Page 24 Chapter 3 - Working with Quality Control ‒ On the Name of Control screen, enter the Each test is included in the QC if the name of this control. corresponding button is filled. Each test is excluded if the corresponding button is To enter text, use the alpha keyboard blank.

  • Page 25: Setting Up Qc For Cassette Tests

    Chapter 3 - Working with Quality Control 5. Use the arrow keys to indicate time of day Using the QC Settings Set Up features, you for each test. can set whether the instrument or operator determines QC pass or fail results. If the 6.
  • Page 26 Chapter 3 - Working with Quality Control ‒ If you are finished making changes, tap The QC Settings-Set QC schedule for Done 4 times to return to the Select cassette test screen displays. Ready screen. 2. Tap Hours and use the arrow keys to ‒...

  • Page 27: Running A Qc Strip Test

    Chapter 3 - Working with Quality Control 6. Tap Days and then Set QC Time. 10. Tap Done. 7. Tap Next. The QC Test-Results Summary screen displays. 8. On the QC Settings-Set QC buffer screen, adjust the buffer time using the arrow Depending on the instrument keys.

  • Page 28: Running A Qc Cassette Test

    Chapter 3 - Working with Quality Control ‒ To pass the test, tap QC PASS. The QC Test-Select PASS or FAIL screen displays. ‒ To fail the test, tap QC FAIL. 9. To select a pass or fail option: 15. Tap Done. ‒...

  • Page 29: Managing The Qc Results

    Chapter 3 - Working with Quality Control 10. To print the results, tap Print. control solution. If the new solution fails again, contact the manufacturer. For more 11. To navigate the pages: information, see the quality control and ‒ To view the next page, tap More. urinalysis strip or cassette instructions for use.
  • Page 30 Chapter 3 - Working with Quality Control Cause Corrective Action CLINITEK Status+ If you cannot analyzer malfunction. successfully complete the quality control procedure, an analyzer malfunction or reagent strip problem may exist. Check the calibration bar for dust, dirt, or scratch marks, or contact your local technical support provider for...

  • Page 31: Chapter 4 Advanced Operations

    Chapter 4 Advanced Operations...

  • Page 32: Overview

    ‒ copying configuration settings communications protocol used to interface ‒ network configuration with your LIS. ‒ customizing printouts Siemens Healthineers recommends you ‒ working with an LIS work with your IT support team when selecting a location for your CLINITEK Copying Configuration Settings Status+ analyzer to ensure adequate wireless coverage is available.
  • Page 33 7. To edit or create the Subnet mask: Ready screen. a. Tap Enter Subnet mask. If you do not run your analyzer with a connector, Siemens Healthineers b. Tap Enter. recommends setting the connector to c. On the Wired Settings screen 2 of 4, tap Disabled setting.

  • Page 34: Connecting To The Lan, Wireless Settings

    Chapter 4- Advanced Operations b. Edit or create the Host port number. a. Tap Enter WEP key. c. Tap Enter. b. Enter the WEP key. The Wired Settings screen 4 of 4 displays. c. Tap Enter. 13. Tap Done. 4. To enter a key index for WEP encryption: The Connectivity screen 2 of 2 displays.

  • Page 35: Managing Printout Settings

    Chapter 4 - Advanced Operations b. Enter the device name. 4. When you complete the settings, tap Next. c. Tap Enter. 5. Select a communication protocol: ‒ If you selected Static, to edit or create the ‒ To use the POCT1 communication IP address: protocol, tap POCT1.

  • Page 36: Working With Barcodes

    Chapter 4- Advanced Operations Working with Barcodes To clear a selected option, tap that option button again. Creating User-defined Barcodes b. Tap Next. You can define barcode formats for Patient ID, The Printer Settings-Included in print-out Operator ID, Control Lot (Strip), and Control Lot screen 2 of 4 displays.

  • Page 37: Working With An Lis

    Working with an LIS Serial Connection The serial transmission between the system You can connect the CLINITEK Status connector and the host is established through the to a host computer or Laboratory Information connector’s rear serial port using a serial System (LIS) using a serial, Ethernet, or cable.

  • Page 38: Communication Protocols

    Chapter 4- Advanced Operations The connector supports the 802.11b and 802.11g wireless network connectivity specifications. Configure the optional wireless connection for wireless transmission between the system and the network. Communication Protocols The CLINITEK Status Connect system can interface with an LIS using either the POCT1A or HL7 communication protocols.

  • Page 39: Chapter 5 Troubleshooting

    Chapter 5 Troubleshooting...

  • Page 40: Overview

    Chapter 5 - Troubleshooting Overview Pre-service Checklist, and in the warranty information printout. If an operational or system problem occurs, an error code or message may display on the Support Information screen with an explanation of the problem. If the problem persists, record the error code, and Legal Information contact your local technical support provider To contact the legal representative for Siemens...

  • Page 41: Orderable Supplies

    Chapter 5 - Troubleshooting Orderable Supplies Part Number Description The orderable supplies have part numbers. 11537775 Operator’s Guide (Portuguese EU) Note The part numbers are subject to change without notice. 11537776 Operator’s Guide (Portuguese Brazilian) Accessory Items 11537777 Operator’s Guide (Danish) The following table lists the accessories available for the connector.
  • Page 42 Chapter 5 - Troubleshooting...

  • Page 43: Appendix A Specifications And Symbols

    Appendix A Specifications and Symbols...

  • Page 44: Connector Specifications

    SELV circuits. specifications for the CLINITEK Status connector. External computing devices connected to the CLINITEK Status connector must comply with You cannot operate the instrument on the standards UL 60950 for US, CAN/CSAC22.2 battery power when using the connector.

  • Page 45: It Security

    This section describes the symbols that can display in the system documentation, the exterior of the CLINITEK Status+ analyzer or CLINITEK Status connector, or on the packaging. The symbols on the system provide you with the location of certain components and with warnings for proper operation.
  • Page 46 Appendix A - Specifications and Symbols Symbol Description This symbol indicates the manufacturer’s authorized representative within the European community. This symbol indicates the name and location of the product manufacturer. This symbol identifies that this electronic information product does not contain any toxic or hazardous substances or elements, and is green and environmental.
  • Page 47 Appendix A - Specifications and Symbols Symbol Description Location of a bar-code scanner port. Location of an Ethernet port. Location of a serial port. Location of the USB port. Input electricity is alternating current. Input electricity is direct current. Do not spray any liquids in this area. Product or container should be oriented in the direction of the arrows.
  • Page 48 Appendix A - Specifications and Symbols...

  • Page 49: Appendix B Barcode Scanner

    Appendix B Barcode Scanner...

  • Page 50: Installing The Optional Barcode Scanner

    Appendix B - Barcode Scanner Overview (available from ASTM, 100 Barr Harbor Dr., West Conshohocken, PA 19428). You can use the barcode scanner to input operator information including Operator ID, Barcode Symbols and Labels Operator Name, patient name, patient ID,strip The connector accepts the data input of lot information, cassette lot information, QC operator-entered information (Patient ID,...

  • Page 51: Barcode Scanner Maintenance

    Appendix B - Barcode Scanner Barcode Description Specification Narrow to Must be within the Wide Ratio specifications for the format being used. This is generally 2.0 to 3.0. Symbol Variable. See Narrow Length Bar Width for more information. Quiet Zone Minimum of 10 times the narrow bar width at each end of the symbol.
  • Page 52 Appendix B - Barcode Scanner...

  • Page 53: Appendix C Glossary

    Appendix C Glossary...

  • Page 54: Hardware Terms

    Appendix C - Glossary Hardware terms Wireless Using the 802.11b or 802.11g specifications to Calibration Bar connect the connector to a LAN. The white calibration bar (on the test table) that Software terms provides traceable calibration. Cassette Alert Message The Clinitest® hCG reagent cassette that is inserted A message that conveys information about the system into the instrument to perform pregnancy tests.
  • Page 55 Appendix C - Glossary Export Screen Title To copy data from the system to a removable data A text label that typically appears in the upper left storage device. corner of a screen which serves as a label for that screen.
  • Page 56 Appendix C - Glossary...
  • Page 57 Revision History Revision History 11537769 Rev. C Chapter/Appendix Description of Changes Table of contents Added headings “Materials Provided”, “Special Materials Required (Not Provided)”, “IT Security”, and “Disposal of the Connector”. Chapter 1: Introduction Added “IVD” symbol and information about the intended user in section “Intended Use”.

  • Page 58: Revision History

    Revision History...

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