DCA Vantage Operators Guide Rev C July 2011

© 2011 Siemens Healthcare Diagnostics. All rights reserved. No part of this manual or the products it describes may be reproduced by any means or in any form without prior consent in writing from Siemens Healthcare Diagnostics. DCA 2000, DCA, and DCA Vantage are trademarks of Siemens Healthcare Diagnostics. Origin: UK

The information in this manual was correct at the time of printing. However, Siemens continues to improve products and reserves the right to change specifications, equipment, and maintenance procedures at any time without notice. If the DCA Vantage® analyzer is used in a manner differently than specified by Siemens, the protection provided by the equipment may be impaired. Observe all warning and hazard statements.

DCA Vantage Operator’s Guide

Contents Using this Guide Conventions ... 10

1 Overview Intended Use... 11 Hardware Overview... 12 Memory ... 13 Connections and Power ... 14 Software Overview ... 15 Screen Components ... 15 Power Save... 15 Menus and Screens ... 16 Home Screen ... 16 Help Menu... 16 Turn Off ... 16 Recall Menu ... 17 System Menu ... 18

2 Installation Hardware Installation... 23 Unpacking the System ... 23 Connect the System Power... 26 Installing the Hardware and External Devices ... 27 Installing the Optional External Barcode Reader ... 27 Installing Printers... 27 Software Setup ... 29 Start Up Tests... 29 Loading Configuration Settings ... 29 Verifying that the DCA Vantage System is Ready ... 30 Configuring Connectivity ... 30 Setting up the Serial Port Connection ... 31 Setting up the Ethernet Port ... 32 Installing Software... 35

3 Operating the System System Access... 37 Operator IDs and Access Codes ... 39 Performing Tests... 41 DCA Vantage Operator’s Guide

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Opening and Inspecting the Reagent Foil Package... 41 Hemoglobin A1c Test ... 44 Microalbumin/Creatinine Test... 58 Recalling Patient Data, Control Tests, and Calibration Data ... 70 Recalling Patient Tests... 71 Reports... 77 Patient Test Reports... 77 Report Components ... 77 Patient Test Graph Report... 78 Control Test Report ... 78 Calibration Data Report... 78 System Setting Report – Full ... 78 System Setting Report – Partial ... 78

4 Calibration Overview ... 79 Calibrating for Hemoglobin A1c ... 79 Calibrating for Microalbumin/Creatinine ... 81 Calibration Data ... 82

5 Quality Control Collecting Control Specimens ... 83 Inserting Capillary Holder into the Reagent Cartridge... 85 Running a Control Test... 85 Quality Control Errors... 87 Setting a Required QC Reminder or Displaying a QC Reminder for New Reagent Lots... 88

6 Maintenance Routine Cleaning... 91 Maintenance Schedule... 91 Turning Off the DCA Vantage System ... 91 Cleaning the Barcode Window... 92 Cleaning the Exterior... 93 Removing and cleaning the cartridge spring and cartridge area... 94 Changing the Air Filter ... 98 Performing Tests... 99 System Tests... 102 User System Test Results ... 104 System Settings ... 104 Loading Paper on the Onboard Printer ... 105 Replacing the Fuse ... 109 Setting Maintenance Reminders ...111 4

DCA Vantage Operator’s Guide

Viewing System Maintenance Status ... 112 System Maintenance Log... 113

7 Troubleshooting System Messages... 115 Troubleshooting the System ... 119 Troubleshooting Reagent Messages ... 123 Errors Codes and Corrective Actions... 123

8 File Management Exporting Patient Data ... 141 Restoring Data ... 141 Saving Data and Settings... 142 Restoring Settings... 142 Deleting Data ... 143

9 Customizing the System Setting Patient Test Options ... 145 Setting Patient Data Entry... 145 Setting Urine Creatinine Units... 145 Setting the HbA1c Reference Range ... 146 Designating the Primary and Secondary HbA1c Reporting Units Algorithm 147 Service Representatives Can Configure the Default HbA1c Algorithm148 Setting User Corrections ... 149 Setting the GFR calculation ... 151 Setting the Patient Recall List Options... 152 Setting Patient and Control Test Delete Options ... 152 Setting Control Test Options ... 152 Setting Control Tests Data Entry ... 153 Setting Control Test Reminders ... 153 Control Test Limits... 154 Setting a Test Lockout... 155 Setting General Options ... 155 Setting the Language ... 155 Volume and Display ... 157 Viewing the Current System Settings ... 158 Customizing Printed Report Headers ... 158

Appendix A: Safety Information Protecting Yourself from Biohazards... 159 References... 160

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Appendix B: Warranty and Support Information Legal Information ... 161 Siemens Authorized Representative... 161 Warranty Information... 161 Installation Details ... 161 Manufacturer’s Warranty... 161 Support Information... 161 Contact Information ... 162 Pre-service Checklist... 163

Appendix C: Orderable Supplies Accessory Items... 165 Replacement Parts ... 165

Appendix D: Symbols System and Packaging ... 167 User Interface... 170

Appendix E: Specifications System Specifications ... 173 System Dimensions ... 173 Environmental Specifications... 173 Electrical Requirements ... 174 Regulatory Specifications... 174 Electrical Precautions... 174 Safety Certifications ... 175 Electromagnetic Compatibility (EMC) ... 175

Appendix F: External Barcode Reader Specifications... 177 Barcode Formats... 177 Barcode Symbols and Labels Specifications ... 177 Installing the External Barcode Reader ... 179 Disabling the External Barcode Reader ... 180 Restoring the Barcode Reader default settings ... 180 Testing the External Barcode Reader ... 180 Maintenance ... 182 Troubleshooting... 182

Appendix G: Computer Interface (LIS)

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General Information ... 183 Ethernet Connections Using POCT1-A... 183 Ethernet Connections Using ASTM ... 184 Serial Connection... 184 Ethernet Connection... 186 Displaying and Printing the MAC address... 186

Appendix H: Glossary Hardware Terms ... 187 Software Terms ... 188 Acronyms... 191

Index

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DCA Vantage Operator’s Guide

Using this Guide The DCA Vantage® Operator’s Guide provides information for physician’s office and laboratory professionals who use the DCA Vantage system. The following table describes how this manual is organized. If you want to . . .

then refer to . . .

learn about the system principles, the hardware, and the operating sequence,

Section 1, Overview.

install the system and configure connectivity,

Section 2, Installation.

process samples, manage sample results, define security, enter Operator IDs and access codes, and manage reference ranges,

Section 3, Operating the System.

learn about calibration and how to print the calibration status,

Section 4, Calibration.

process Quality Control samples,

Section 5, Quality Control.

perform maintenance activities,

Section 6, Maintenance.

investigate and correct system problems,

Section 7, Troubleshooting.

learn about managing data,

Section 8, File Management.

learn about changing the system settings, system configuration, display the software version and system serial number

Section 9, Customizing the System.

review additional information, such Appendices. as the glossary, safety, external barcode reader, or the supplies list,

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Conventions The DCA Vantage Operator’s Guide uses the following text and symbol conventions: Convention

Description

BIOHAZARD

Biohazard statements alert you to potentially biohazardous conditions.

WARNING

Warning statements alert you to conditions that may cause personal injury.

CAUTION

Caution statements alert you to conditions that may cause product damage or loss of data.

NOTE:

Note statements alert you to important information that requires your attention.

Bold

Bold type indicates text or icons on the user interface. For example, if the word save appears as Save, it refers to the Save key on the user interface. System icons are also indicated by words in bold type. For example, the words Next Screen refer to a system icon. A complete list of system icons and their equivalents is in Appendix D, Symbols.

Italic

Italic type refers to the title of a document or a section title in this manual.

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DCA Vantage Operator’s Guide

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Overview

The DCA Vantage system is a semi-automated, benchtop system. It is designed to quantitatively measure the percent of Hemoglobin A1c in blood and low concentrations of albumin in urine (microalbuminuria), creatinine in urine, and the albumin/creatinine ratio in urine. The DCA Vantage system is intended for professional use in a physician’s office or hospital laboratory. Tests performed using the DCA Vantage system are intended for in vitro diagnostic use. As with all diagnostic tests, do not base a definitive diagnosis on the results of a single test. A physician should make a diagnosis after all clinical and laboratory findings are evaluated. The system is a spectrophotometer that analyzes the intensity of the light transmitted through the cartridge optical window and reports the results in clinically meaningful units. No calculations are required by the user. When you swipe a calibration card, the barcode reader reads the card and the system automatically performs the calibration.

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Overview

Intended Use

Hardware Overview Overview

The DCA Vantage system consists of these functional areas: •

reagent cartridge compartment

•

onboard barcode reader

•

display/touchscreen

•

printer

1

Printer Display Screen Reagent Cartridge Compartment Onboard Barcode Reader

2 3 4

Figure 1 DCA Vantage System

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DCA Vantage Operator’s Guide

Interaction with the DCA Vantage system is via an integrated touchscreen. Messages, options, and requests for information display, and responses are made by selecting the appropriate key symbol on the screen.

Overview

CAUTION

Do not use anything hard or pointed on the touchscreen. It can damage the touchscreen. Use the onboard barcode reader to calibrate the system and scan the reagent cartridges and control cards. The reagent cartridges are placed in the reagent cartridge compartment where the tests are run, and when testing is complete, an internal thermal printer prints the test results. You also can use a handheld barcode reader to enter certain information into the system.

Memory The operating system, the system software, the test data, and the system settings for the DCA Vantage system are stored in an onboard (nonremovable) flash memory. You can insert a Universal Serial Bus (USB) Flash memory drive into the system’s USB port to save data and system settings. You can then insert the USB memory drive into another DCA Vantage system and restore the data to the new system. You can transfer patient data from one DCA Vantage system to another using the software backup and restore sequences in system settings, refer to File Management‚ page 141. NOTE: You cannot import data from a spreadsheet into a DCA Vantage system.

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Connections and Power

Overview

Ensure that the power cord connects into the power cord receptacle. Turn the system on by pressing the power switch to the On position. You can connect a USB flash memory drive, a printer, an ethernet device, and a handheld barcode reader to the system using the interface connectors.

1 2 3

External Connections Power Plug Power Switch

Figure 2 Power and External Connections

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DCA Vantage Operator’s Guide

Software Overview The DCA Vantage system provides an easy-to-navigate and intuitive user interface.

Overview

Screen Components The DCA Vantage system software screens use a consistent layout.

1 2 3 4 5 6

Screen Title Module Icon and Title Time and Date Title Bar Content Area Navigation and Contextual Help Button Area

Figure 3 Screen Components

Some options require that you enter information. If selected, a numeric keypad or an alphanumeric keypad displays. An onboard barcode reader is included and reads only barcodes of DCA® cartridges and calibration cards. NOTE: The DCA Vantage system does not support the connection of an external computer keyboard or a mouse to enter data. Refer to Appendix D, Symbols, for a complete list of key symbols used on the DCA Vantage system.

Power Save When the system is not in use for more than 30 minutes, Power Save automatically turns on. The system checks to ensure that no tests are in progress and data is not being imported or exported before entering power save. Touch the screen, open a cartridge compartment door or use the internal barcode scanner to resume operations.

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Menus and Screens Overview

Home Screen The Home screen displays after the DCA Vantage system completes its initialization. The Home screen displays the state of the system and is the starting point for Patient and Control Test Sequences. From the Home screen, you can select: •

Help

•

Turn Off

•

Recall

•

Menu

If the system is in the Not Ready state and you cannot initiate a Patient or Control Test Sequence, an alert message displays explaining why the system is not ready. If the system is in the Ready state, you can start a patient test and scan either an HbA1c or a Microalbumin/Creatinine cartridge. Notifications or error messages display at the Home screen and provide information about the state of the DCA Vantage system. Viewing Events Notification An Event Notification window displays at the Home screen when a maintenance task is due, an error event occurs, or a required or optional control test notification is posted. 1. At the Home screen, select Events. The Events List screen displays the information about the notification. 2. Use the up and down arrows to scroll through the notifications. 3. To return to the Home screen, select Back. NOTE: The Events Notification window closes after you clear all events.

Help Menu The Help menu provides information about the DCA Vantage system. You can also display the software version number at the Help screen. To access the Help menu, select Help from the Home screen.

Turn Off You can leave the DCA Vantage system powered on except during maintenance and cleaning procedures. If you need to power off the system, refer to Turning Off the DCA Vantage System‚ page 91.

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DCA Vantage Operator’s Guide

NOTE: You do not have to reconfigure system settings when turning the

power on, the system stores the saved settings.

The Recall menu provides access to patient test results, control test results, and calibration data. At the Patient Tests screen you can recall patient test data and export to a USB device for backup. To access the Recall menu, select Recall from the Home screen, and select Patient Tests. Table 1 Patient Tests

Select . . .

then . . .

to . . .

HbA1c

View Last 10

see the last 10 results performed.

search by Patient ID or last name. You can graph HbA1c results using the Patient ID search. The sort order is the reverse order in Patient ID/Name which the tests were run. If there is not an entry for a Patient ID or Last Name, the field is blank. You also can delete test results from this screen. Date Range

Comment 1

Results/Range

Graph

DCA Vantage Operator’s Guide

enter a Start and End Date to search patient results during for a specific time frame. search by the first comment of the 8 comments that are available. To perform a wildcard search, use the percent (%) sign at the end the entry. use the Set Lower Limit screen to set the HbA1c search filter value when doing a search by result range. The Lower Search Limit displays in the units of the primary algorithm and cannot be set lower than 2.5% for NGSP, 2.0% for JDS, 1.5% for mono-S, or 4 mmol/mol for IFCC. The search returns any test result that is greater than the lower limit set. display HbA1c results in graph format. After searching by patient ID, narrow the search using a date range. The graph displays. You can print the graph to the external printer.

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Overview

Recall Menu

Select . . .

then . . .

MicroAlbumin View Last 10

to . . . see the last 10 results performed.

Overview

search by Patient ID or last name. The sort order is the reverse order in which the tests Patient ID/Name were run. If a Patient ID or Last Name is not entered for the patient, the field will be blank. You also can delete test results. Date Range

Comment 1 Export

enter a Start and End Date to search patient results during for a specific time frame. search by the first comment of the 8 comments that are available. To perform a wildcard search, use the percent (%) sign at the end the entry. copy data to a USB storage device.

System Menu Select Menu from the Home screen to access Control Tests, System Maintenance, System Settings, and System Tests. You can also schedule and change the configuration of control tests. Table 2 Menu

Select . . .

to . . .

Control Tests

see a read-only status of required and optional Control tests. Select Log to see up to 100 entries.

System Maintenance

view the list of maintenance tasks and the status of each one. A task that has been performed can be selected and marked as complete on this screen. This task also appears on the System Maintenance Log screen.

System Settings

System Tests

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change sound volume, adjust the display contrast, access Additional Settings menu, and view current settings. perform system tests including testing printers, barcode readers, external ports, optical tests, and calibrating the touchscreen.

DCA Vantage Operator’s Guide

Additional Settings Select Additional Settings from the System Settings screen to customize the system and add external devices.

Overview

To access Additional Settings, select Menu from the Home screen, select System Settings, and then Additional Settings. Table 3 Additional Settings

Select . . .

then . . .

Patient Tests Data Entry

Urine Creatinine Units

to . . . specify the data and comments that are entered when a patient test is run such as Sample ID, Patient ID, First Name, Last Name, Comments (1–8), Operator ID. You can also indicate if these are optional or required. set the creatinine results to either mg/dL or mmol/L.

specify the upper and lower reference range Reference Range values for HbA1c results. Display, print, and transmit reference range values

Albumin User Correction

adjust the slope and offset for the HbA1c, Albumin and Creatinine values. adjust the slope and offset for the HbA1c, Albumin and Creatinine values.

Creatinine User Correction

adjust the slope and offset for the HbA1c, Creatinine values

Hb1Ac User Correction

turn the GFR Calculation on or off, and select GFR Calculation the unit of measurement to be used for plasma creatinine. Patient Recall List Options

set the search criteria and display for patient results. When performing a search in Recall, you can search by either Patient ID or Last Name.

Control Tests Data Entry

specify the data and comments that are entered when a control test is run and which data is required or optional.

Reminders

access to the Control Test Log and allows you to view and change the schedule for the Control Tests.

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