Siemens
DCA Vantage Operators Guide Rev B June 2008
Operators Guide
164 Pages
Preview
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© 2008 Siemens Healthcare Diagnostics Inc. 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
Using this Guide Conventions ... 7
1 Overview Intended Use... 9 Hardware Overview... 10 User Interface... 10 Testing and Printing Areas ... 11 Connections and Power ... 11 Memory ... 12 Software Overview ... 12 Screen Components ... 13
2 Operating the System Turning the system off... 15 Overview ... 15 Using the Home Screen ... 15 Viewing Events Notification... 15 System Settings Wizard ... 16 Accessing the System Settings Wizard... 16 Test Sequences... 16 Hemoglobin A1c... 16 Microalbumin/Creatinine Test... 30 Recall Menu ... 43 Accessing Patient Tests ... 43 System Menu ... 49 Control Tests ... 49 Setting Control Test Reminders ... 51 Setting Other Manufacturer Controls ... 52 System Tests... 52 System Settings ... 54 Supervisor ID ... 55 Additional Settings ... 55 Patient Tests... 55 Control Tests ... 60 Supervisor List ... 60 General Setting Menu ... 61 System Access... 63 Setting a Test Lockout... 64 System Settings Wizard ... 65 Deleting Patient and Control Test Data ... 65 Saving Data and Settings... 65 DCA Vantage Operator’s Guide
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Deleting Data ... 66 Restoring Data ... 66 Restoring Settings... 67 Installing Software... 67 Printers Menu... 68 Enabling the Serial Port Menu ... 70 Ethernet Port menu ... 72 Support ID Entry... 76 Patient Test Reports ... 76 Patient Test Graph Report... 76 Control Test Report ... 77 Calibration Data Report... 77 System Setting Report - Full ... 77 System Setting Report - Partial... 77 Report Components ... 77
3 Calibration Overview ... 79 Calibrating for Hemoglobin A1c ... 79 Calibrating for Microalbumin/Creatinine ... 81 Calibration Data ... 82
4 Quality Control Collecting Control Specimens ... 83 Inserting Capillary Holder into the Reagent Cartridge... 85 Running a Control ... 85 Control Level Selection ... 87 Quality Control Errors... 88
5 Maintenance Maintenance Schedule ... 89 Cleaning the Barcode Window... 89 Cleaning the Exterior... 90 Removing and cleaning the cartridge spring... 91 Changing the Air Filter ... 95 Running the Optical Test ... 96 Calibrating the Touchscreen... 99 Changing the Paper ... 99 Replacing the Fuse ... 103 Viewing System Maintenance Status ... 105 Setting Maintenance Reminders ... 105 System Maintenance Log... 106
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6 Troubleshooting General Information ... 107 Errors and Corrective Actions ... 108
7 File Management 8 System Configuration Installation ... 125 Overview ... 125 Unpacking the System ... 125 Installing the System ... 126 Installing Connections ... 128 Installing the External Barcode Reader ... 128 Installing a Roll of Printer Paper... 128 Starting the DCA Vantage System ... 129 Running the Optical Test Cartridge ... 129
Appendix A: Safety Information Protecting Yourself from Biohazards... 131 References... 132
Appendix B: Warranty and Support Information Legal Information ... 133 Siemens Authorized Representative... 133 Warranty Information... 133 Installation Details ... 133 Manufacturer’s Warranty... 133 Support Information... 133 Contact Information ... 134 Pre-service Checklist... 135
Appendix C: Orderable Supplies Accessory Items... 137 Replacement Parts... 137 System Documentation ... 138
Appendix D: Symbols System and Packaging ... 139 User Interface... 142
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Appendix E: Specifications System Specifications ... 145 System Dimensions ... 145 Environmental Specifications... 145 Electrical Requirements ... 146 Regulatory Specifications... 146 Electrical Precautions... 147 Safety Certifications ... 148 Electromagnetic Compatibility (EMC) ... 148
Appendix F: External Barcode Reader General Information ... 149 Installing the External Barcode Reader ... 149 Testing the External Barcode Reader ... 150 Troubleshooting... 150 Specifications... 150 Barcode Formats... 150 Barcode Symbols and Labels ... 150 Maintenance ... 152
Appendix G: Computer Interface (LIS) General Information ... 153 Cable and Pin Specifications – Computer ... 153 Serial Connection... 153 Ethernet Connection ... 154
Appendix H: Glossary Hardware Terms ... 155 Software Terms ... 156 Acronyms... 158
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.
process samples and manage sample results,
Section 2, Operating the System.
learn about calibration and how to print the calibration status,
Section 3, Calibration.
process Quality Control samples,
Section 4, Quality Control.
perform maintenance activities,
Section 5, Maintenance.
investigate and correct system problems,
Section 6, Troubleshooting.
learn about file management,
Section 7, File Management.
install the system or modify system Section 8, System Configuration. parameters, review additional information, such as the glossary or the supplies list,
appendices.
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.
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Convention
Description
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
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Italic type refers to the title of a document or a section title in this manual.
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Overview
The DCA Vantage 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.
Figure 1 DCA Vantage System
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 an operator swipes 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
User Interface By default, 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.
CAUTION
Do not use anything hard or pointed on the touchscreen. It may damage the screen. You can also use a handheld barcode reader to enter certain information into the system. The DCA Vantage system user interface is divided into the following 3 modules: •
Test Sequences
•
Recall
•
System
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DCA Vantage Operator’s Guide
Testing and Printing Areas All testing takes place at the DCA Vantage system.
The barcode reader is used 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.
Figure 2 User Interface, Testing, and Printing Areas 1 2 3 4
Onboard Barcode Reader Printer Display Screen Reagent Cartridge Compartment
Connections and Power The power cord is connected into the power cord receptacle. Turn the system on by pressing the power switch to the on position. You can connect a Universal Serial Bus (USB) flash memory drive, a printer, an ethernet device, and a handheld barcode reader to the system using the interface connectors.
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Overview
The DCA Vantage system consists of 4 functional areas: the reagent cartridge compartment, the onboard barcode reader, the display screen, and the printer.
Overview
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 USB Flash memory drive into the system’s USB port during the Back up sequence. 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 System Configuration‚ page 125. NOTE: You cannot import data from a spreadsheet into a DCA Vantage system.
Figure 3 Power Connection, Power Switch, and Connections 1 2 3
Connections Power Switch Power Cord
Software Overview The DCA Vantage system provides an easy-to-navigate and intuitive user interface. When the system is not in use for more than 30 minutes, the Power Save Mode automatically turns on. Touch any location on the screen to resume operation.
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Screen Components The DCA Vantage system software screens use a consistent layout.
Overview
Figure 4 Screen Components 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
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.
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Operating the System
You can leave the DCA Vantage system on always, except during maintenance and cleaning procedures.
Turning the system off To save power, you can turn the system off when it is not in use.
2. To shut down the system, select Yes. 3. Turn the power switch to the off position when the system shut down is complete.
Overview You can test blood for the percent concentration of HbA1c, and urine for concentrations of microalbumin and creatinine. Results are available in 6 or 7 minutes. NOTE: You can use DCA 2000 and DCA 2000+ cartridges on the DCA Vantage analyzer.
Using the Home Screen The Home screen displays after the DCA Vantage system completes its initialization, refer to System Configuration‚ page 125. The Home screen displays the state of the system and is the starting point for Patient and Control Test Sequences. 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 test cartridge. You can access the Recall menu and the System menu from the Home screen. Notifications or error messages display at the Home screen and provide you with 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 optical control test notification is posted.
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Operating the System
1. At the Home screen, select Turn Off. A message displays asking if you want to shut down the system.
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.
Operating the System
System Settings Wizard The System Settings Wizard is displayed the first time you turn the DCA Vantage system on. The wizard automatically displays the screens that are frequently used to set user preferences. Follow the instructions at the System Settings Wizard screen to set your system preferences. NOTE: You can access the System Settings Wizard after the initial setup.
Accessing the System Settings Wizard 1. Select System Settings from the System menu. The Settings menu displays. 2. Select Additional Settings from the Settings menu. The General Settings menu displays. 3. Select Settings Wizard. The System Settings Wizard runs the next time the system is turned on.
Test Sequences The following sections explain the test sequences you can perform using the DCA Vantage system.
Hemoglobin A1c The following section explains the test sequence for an HbA1c test. Preparing Patient Samples and Controls for Hemoglobin A1c Test Materials Required: •
DCA 2000® or DCA Systems Hemoglobin A1c Reagent Kit (for use with the DCA Vantage system)
•
Patient sample
•
Control Kit or other control
•
Lint-free tissue
•
Clock or timer
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For information on preparing controls, refer to Quality Control‚ page 83. For information on calibrating, refer to Calibrating for Hemoglobin A1c‚ page 79. Opening the Foil Package
CAUTION
1. Remove one foil package (containing a reagent cartridge) from storage. For more information, see Recommended Procedures for Handling Reagent Cartridges in the DCA Systems Hemoglobin A1c Reagent Kit package insert for instructions on how and when to open the foil package. 2. Open the foil package.
Figure 5 Opening Reagent Cartridge Package
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Operating the System
Do not use scissors to cut open the foil package. Scissors can damage the reagent cartridge, the flexible plastic pull-tab on the cartridge, or the desiccant bag.
3. Remove the contents of the package. Inspecting the Contents of the Foil Package The foil package includes the contents displayed below:
CAUTION
Operating the System
When handling the reagent cartridge, do not touch or otherwise contaminate the optical window or erroneous test results may occur.
Figure 6 DCA Systems Hemoglobin A1c Reagent Cartridge Package 1 2 3 4
Flexible Pull Tab Reagent Cartridge Desiccant bag Optical Window
Discard the reagent cartridge if any of the following conditions exist: •
The cartridge is damaged.
•
The flexible pull-tab is loose or missing.
•
The desiccant bag is missing or open.
•
Loose desiccant particles are found inside the foil package.
•
If the foil package is open for more than 60 minutes.
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Performing a DCA Hemoglobin A1c Test BIOHAZARD
Wear personal protective equipment, including safety glasses and gloves. Use universal precautions. Refer to Safety Information‚ page 131, for recommended precautions when working with biohazardous materials. NOTE: You can save unused capillary holders and use them with any lot of
DCA Hemoglobin A1c reagent cartridges.
Operating the System
1. Open the plastic wrap of the capillary holder by tearing the wrap at the serrated edge with the arrow. 2. Inspect the capillary holder for the presence of the following parts: • absorbent pad •
glass capillary
•
latching mechanism
If the capillary holder is missing any of the above parts, discard the capillary holder.
Figure 7 Capillary Holder 1 2 3
Glass Capillary Absorbent Pad Latching Mechanism
Filling the Capillary with Whole Blood When the capillary is filled with the sample, analysis must begin within 5 minutes. Filling the Glass Capillary with Blood from Finger Stick 1. Hold the capillary holder at an angle. DCA Vantage Operator’s Guide
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2. Touch only the tip of the capillary to a small drop of blood on the finger until the capillary fills.
Operating the System
NOTE: 1 µL of blood is required to fill the capillary.
Figure 8 Filling capillary holder with blood from finger stick 1
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Glass Capillary Tip
DCA Vantage Operator’s Guide