IVD PA20 User Manual Version 1.0 BCA-PA20 SAMSUNG ELECTRONICS CO., LTD. 129, Samsung-ro, Yeongtong-gu, Suwon-si, Gyeonggi-do, Korea Distribution in USA : Nexus Dx, Inc., A Subsidiary of Samsung Electronics Co., Ltd., 6759 Mesa Ridge Road, San Diego, CA 92121 USA / Tel : 858-410-4600, Fax : 858-410-4700, www.nexus-dx.com For proper use of the analyzer, please refer to the product manual.
Copyright © Copyright Reserved 2012 Samsung Electronics Co., Ltd The hardware/software mentioned in this user manual is protected by copyright law. Except for a copy of the User Manual for normal use, making a partial or whole copy of it without written permission by Samsung Electronics is strictly prohibited by copyright law. The content and specifications of this user manual are subject to change without prior notice.
Table of Contents 1. Safety Warnings and Caution ........................7 User’s Manual and Labeled Symbols ................................. 9 Cautions for system installation ....................................... 11 Cautions for system move ................................................. 12 Cautions before use ............................................................ 12 Cautions during use ............................................................ 13 Precautions Before Testing .................
Samsung LABGEO PA20 Table of Contents Disc ......................................................................................... 29 Handling and Storage of the Disc .................................... 30 Adding the sample to the Disc.......................................... 31 4. Analyzing ......................................................35 Analyzing .............................................................................. 36 Turning power on ...............................................
Samsung LABGEO PA20 Table of Contents QC material ........................................................................... 84 Registering QC Material .............................................................................84 Changing QC material ...............................................................................89 Deleting QC material ..................................................................................91 Print settings .....................................................
Samsung LABGEO PA20 Table of Contents Running the LABGEO Data Manager .............................139 Home screen .......................................................................140 Registering a blood analyzer device .................................................. 141 Viewing analysis results ...................................................147 Editing analysis results .....................................................148 Selecting and editing multiple analysis results ...................
1 Safety Warnings and Caution User’s Manual and Labeled Symbols ................................................. 9 Cautions for system installation ....................................................... 11 Cautions for system move ................................................................. 12 Cautions before use ............................................................................ 12 Cautions during use ............................................................................
Safety Warnings and Caution Please follow the safety warnings and cautions in this manual for safe and appropriate use of the product. Repairs and maintenance work not explained in this User Manual are to be performed by a designated Samsung service provider. Any attempt to repair the product by the user may result in injury. Do not use the product in an area with combustible gas or high levels of contamination for an extended period of time.
Samsung LABGEO PA20 Safety Warnings and Caution Ŷ User’s Manual and Labeled Symbols Symbol Explanation Biohazard. A sample as well as a used cartridge containing a sample are potentially hazardous. Handle with care. Caution. In order to safely and properly use this product, safety precautions and cautions in this manual must be followed. Consult instruction for use.
Samsung LABGEO PA20 Safety Warnings and Caution Symbol Explanation ‘New’ waste The bar can be replaced by the date of manufacture Catalog number North American Safety Certification Mark Alternating current Power On Power Off Hot Surface Risk of electronic shock Stand-by switch LASER CLASSIFICATION This Clinical Chemistry and Immunology Analyzer is confirmed as the class 1 laser product in IEC60825-1:2007 - Wavelength: 808 nm - Maximum output of laser radiation: Max. 1.
Samsung LABGEO PA20 Safety Warnings and Caution Ŷ Cautions for system installation Ŷ Keep the analyzer at least 6 inches (15 cm) away from any wall to provide adequate ventilation and prevent overheating. Ŷ Be careful not to expose the analyzer to sources of vibration such as placing it near a centrifuge. Ŷ Do not use the analyzer where liquids or chemicals are used or where gas may be produced.
Samsung LABGEO PA20 Safety Warnings and Caution Ŷ Cautions for system move Ŷ Dropping the product while moving or carrying may cause damage to the product. Ŷ Be careful of impact when moving the product at all times. Ŷ When moving the product by car, please use the original packaging material. When moving the analyzer, first turn off the power and disconnect the power cable from the product.
Samsung LABGEO PA20 Safety Warnings and Caution Ŷ Cautions during use Ŷ This system is for professional use only. The user must be a physician, clinical laboratory personnel, or healthcare professionals. Ŷ Avoid external shock or vibration during analysis. Ŷ Do not use expired discs. Ŷ Do not open the tray while the disc is being analyzed. During the analysis, LED lamp or laser radiation may cause hazard due to improper operation. Ŷ The Analyzer contains UV/Visible LED Light source and laser.
Samsung LABGEO PA20 Safety Warnings and Caution Ŷ Precautions Before Testing Preparing to Test Samples 1 Prepare a disc, sample, and injecting tool (pipette) to be used for the test. 2 Consult Test Instructions for Use. 3 Use a pipette to inject the sample into the disc as described in the Test Instructions for Use. Inlet 4 Inject into the inlet shown in the figure above as described in the Test Instructions for Use.
Samsung LABGEO PA20 Safety Warnings and Caution Ŷ Cautions for storage and maintenance after use Ŷ Do not store the product in humid areas or areas influenced by temperature, humidity or wind. Ŷ Store the device on a flat surface and keep it away from vibration or impact. Ŷ Do not store the product with chemicals or gas.
Samsung LABGEO PA20
2 Introduction Intended Use ........................................................................................ 18 Introduction ......................................................................................... 19 Operating Principle ............................................................................. 20 What’s in the box ................................................................................. 20 Box contents .....................................................................
Introduction Ŷ Intended Use The Samsung LABGEOPA20 provides quantitative in-vitro measurements of clinical chemistry analytes and immunological reactions in lithium-heparinized whole blood, plasma, or serum in a clinical or point-of-care setting. It is designed to use a disposable reagent disc which contains reagents and buffers for a complete test. The Analyzer unit contains the Laser which is for controlling microfluidics. UV LED is light source is for detection chemical reaction.
Samsung LABGEO PA20 Introduction Ŷ Introduction The Samsung LABGEOPA20 is a fully integrated photometric device that can perform both clinical chemistry analyses and immunoassays simultaneously. Innovative laser-actuated microvalves together with the centrifugal microfluidics makes the total process of plasma separation, metering, mixing, incubation, washing, and detection fully automatic.
Samsung LABGEO PA20 Introduction Ŷ Operating Principle The analyzer is equipped with two optical detection modules. One is a photometer and the other is a fluorometer. The photometer can measure absorbance at 10 different wavelengths (340, 405, 450, 500, 550, 570, 600, 630, 660, and 700 nm) to accommodate various chemical and immunological reaction protocols. The measured absorbance is converted into the concentration of the analytes.
Samsung LABGEO PA20 Introduction User Manual Software installation CD Sold separately Pipette tips Disc Control Serum Barcode scanner (optional) t Please check the above contents of the box after purchase. t If any of the contents are missing or damaged. Do not use the product and contact your retailer for a replacement.
Samsung LABGEO PA20 Introduction Ŷ Introduction of features Front (Right) 1 2 3 6 7 4 5 8 9 1. Main Unit 2. Printer 3. Printer feed button 4. 7-inch Color TFT LCD Monitor 5. Tray 6. Power Button: Used to turn the analyzer on or off 7. USB Port: Used to update the software and to back up the analysis results in the USB memory 8. Servicing Hole: For qualified Samsung Technical Support personnel only 9.
Samsung LABGEO PA20 Introduction Front (Left) 1 2 1. Class 1 laser product label 2.
Samsung LABGEO PA20 Back 1 3 4 2 5 6 7 8 9 1. Power Switch: Used to turn the power to the analyzer on or off, turning off this switch completely cuts the power off. 2. Power Input: Connect the Power Cable here : Used to update the software and to back up. The smaller port is provided 3. USB Port for connecting to a computer 4. Ethernet Port : Used to connect to LAN or the Internet 5. Cooling Fan 6. Biological Hazard Warning 7.
3 Installation Installation ............................................................................................ 26 Replacing printer paper ..................................................................... 27 Disc ......................................................................................................... 29 Handling and Storage of the Disc .................................................... 30 Adding the sample to the Disc..........................................................
Installation Ŷ Installation 1 Carefully remove the analyzer from the packaging, and check for any damage that may have occurred during transport. If it is damaged, contact your courier or retailer immediately. Check and make sure that the contents of the box match the contents described in the User Manual. Contact your retailer if any component is missing. 2 Place the analyzer on a level surface near an appropriate AC electrical outlet.
Samsung LABGEO PA20 Installation Ŷ Replacing printer paper 1 Open the paper lid (pull the lid upward by the handle). 2 Remove the used roll. 3 Unwind a new paper roll so that the leading edge comes out from the bottom, facing the user. 4 Gently insert a new roll into the receptacle, and confirm that the paper comes out through the front of the printer while holding the leading edge.
Samsung LABGEO PA20 Installation 5 28 Close the lid and confirm that the paper is positioned between the lid and the front of the printer.
Samsung LABGEO PA20 Installation Ŷ Disc The actual disc may differ from the images shown below. 1 2 4 3 1. Sample injection Hole 2. Reagent 3. Disc Barcode 4. Detection area (gray-colored zone) Care must be taken to keep the detection area clear of fingerprints or other foreign substances. Contamination of the detection area may affect the analysis results.
Samsung LABGEO PA20 Installation Ŷ Handling and Storage of the Disc Handle the discs carefully to avoid damaging them. The disc is a high-technology integrated product but is vulnerable to impacts. Be careful not to bump the disc when transporting, handling or loading it. Do not use the disc if it has been dropped. t Always use powder-free gloves when handling the product. t Store the disc LEVEL between 2 - 8 °C (36 - 46 °F). t Use by the expiry date marked on the disc pouch or the package label.
Samsung LABGEO PA20 Installation Ŷ Adding the sample to the Disc It is advisable to power up the instrument prior to loading the sample on the disc. See page xx. Ŷ Bring the refrigerated, unopened disc to room temperature for at least 10 minutes before opening it. Once opened, the disc must be used within 10 minutes. Load the disc on the Analyzer within 10 minutes after injecting the sample. Discs are fragile — always handle with care. Do not tap discs on the workbench.
Samsung LABGEO PA20 Installation Ŷ SAMPLE INJECTION t Correct injection volume t Insufficient sample volume Analyzer will show message that insufficient sample has been injected. Carefully pipette an additional 100 μL ~ 250 μL into the sample injection hole. Tap Retry on analyzer.
Samsung LABGEO PA20 Installation t Excessive sample injection During analysis, any surplus sample will move into the overflow chamber as shown below: (surplus sample ĺ overflow sample chamber) Injecting more than 750 μL may cause sample chamber to overflow. Ŷ Do not use expired discs. Ŷ Be careful to insert the disc into the analyzer properly. When inserting the disc the blood sample hole should be facing up.
Samsung LABGEO PA20
4 Analyzing Analyzing .................................... 36 QC material ................................. 84 Turning power on ................................. 36 Preparing analysis................................. 40 Canceling analysis in progress ........ 43 Analysis completed ............................. 45 Viewing analysis results ...................... 47 Registering QC Material...................... 84 Changing QC material ........................ 89 Deleting QC material ........................
Analyzing Ŷ Analyzing Turning power on 1 Before beginning analysis, turn the device’s power on. Turn the analyzer’s power on. (Set the power switch in the back to ON, and press the POWER button on the front of the device.) Once the analyzer is turned on, it requires about 2~5 minutes to preheat. If the power doesn’t turn on, refer to page 159 “7. Troubleshooting”.
Samsung LABGEO PA20 Analyzing 2 Once the analyzer is turned on, it performs a hardware check, and the home screen, shown below, is displayed. 1. Results: Select Results menu to view the results of a completed analysis. Please refer to ‘4. Analyzing - Viewing results (page 48)’ for more details.
Samsung LABGEO PA20 Analyzing 2. Analysis Information: Select Run menu to enter analysis information and perform blood analysis. 3. QC Run: This is the start menu of QC Run.
Samsung LABGEO PA20 Analyzing 4. Settings: Select Settings menu to adjust display, volume, analysis, language, peripherals and self-testing options. When logging in as an administrator, you can view the status of locking, network, time, and system settings.
Samsung LABGEO PA20 Analyzing Preparing analysis 1 Press the Run button. Ŷ Up to 5,000 analysis results can be stored on the analyzer. The device shows a backup warning when the available space is less than 100 records. Please refer to ‘4. Analyzing - USB Backup (page 127)’ for instructions on backing up analysis results. 2 Screen for entering Analysis Information is displayed on the LCD. Enter patient information and press the OK button. t To display the keypad, tap on an empty field.
Samsung LABGEO PA20 Analyzing 3 Insert a disc loaded with a sample into the tray when it opens, and press the Run button. The disc tray closes automatically if the Run button is not tapped within 30 seconds after inserting the disc.
Samsung LABGEO PA20 Analyzing 4 As the tray closes, the analyzer performs a disc validity check. 5 After completing the validity check, the test starts while the remaining time and progress is displayed on the screen.
Samsung LABGEO PA20 Analyzing Canceling analysis in progress 1 To cancel a test for Disc Validity Check or during the blood analysis stage, press the Cancel button.
Samsung LABGEO PA20 Analyzing 2 Press the Yes button to cancel, and the No button to resume the analysis. Ŷ When an analysis in progress is canceled, the disc cannot be used again.
Samsung LABGEO PA20 Analyzing Analysis completed 1 When the analysis is completed, an audio notification plays and the analysis results are displayed on the LCD. t Analytes and analysis results are displayed. t If auto-print is turned on, the device automatically prints the analysis results upon completion. 9 For instructions on adjusting auto-print settings, please refer to “Settings – Peripherals” (page 93).
Samsung LABGEO PA20 Analyzing The following symbols are displayed when the results are not within normal values. When results exceed the reference range When results exceed the analyzer’s detection range When QC fails Tip 2 46 The audio notification for completion of the test can be adjusted. To adjust the volume, please refer to Settings – Volume (page 76). Press the button to remove disc from the open tray.
Samsung LABGEO PA20 Analyzing Viewing analysis results 1 Once the analysis is completed, the results are displayed on the LCD. t Analysis results can also be viewed by selecting Results on the home menu. 2 To view detailed results of each analyte, press the Show detail button on the upper right corner. t Press the Up/Down button to select an analyte from the list.
Samsung LABGEO PA20 Analyzing Ŷ Viewing results Press the Result button on the home screen to display the Results. Results are grouped by All, Patient and Material QC.
Samsung LABGEO PA20 Analyzing Ŷ Quality Control 49
Samsung LABGEO PA20 Analyzing Viewing results of patient’s analysis 1 Press the Patient Results button to enter the Simple View screen. 2 To view detailed results of each analyte, press the Show Detail button in the upperright corner.
Samsung LABGEO PA20 Analyzing 3 When you select the patient ID, you can view the patient’s date of birth, gender and operator ID. 4 To switch to the previous or next result screen, press the arrow buttons on the left and right side of the screen.
Samsung LABGEO PA20 Analyzing Viewing QC results 1 Press the QC Results button to switch to the simple view screen. 2 To view detailed results of each analyte, press the Show Detail button on the upper right corner.
Samsung LABGEO PA20 Analyzing 3 To switch between the simple view and show detail screens, press the arrow buttons on the left and right side of the screen. 4 Press each analyte to enter the QC chart screen. 5 QC chart screen displays the QC results of each analyte in a graph.
Samsung LABGEO PA20 Analyzing Searching results 1 Press the Results button on the home screen to display the Results screen. 2 Press the Search button in the upper-right corner to enter the Search Results screen.
Samsung LABGEO PA20 Analyzing 3 Enter an ID or date and press the OK button to see matching results. 4 To print the results, select the results you wish to print and press the Print button. To transfer the results to a PC software (LABGEO Data Manager) or EMR/LIS, select the results you wish to transfer and select the Send button.
Samsung LABGEO PA20 Analyzing Printing results Printing analysis results, including patient ID in certain languages, requires the analyzer’s language setting to be set in that language to print correctly. Printing multiple analysis results 1 From the results screen, check the boxes next to the results you wish to print. 2 To print all the analysis results on the page or all the analysis results stored, check the box in the upper-left corner of the chart.
Samsung LABGEO PA20 Analyzing 3 Select either print range option: Select all within the page or Select all across the pages. 4 When you press the Print button, a pop-up window is displayed. Press the OK button to begin printing. t Press the Cancel button to cancel printing. t Only results requested with the check box will be printed.
Samsung LABGEO PA20 Analyzing 5 Once the data is transferred, the printer prints the results. Printing analysis results by analytes Specific analytes of analysis results can be selectively printed. 1 58 On the Results screen, press Patient Results to enter the simple view screen.
Samsung LABGEO PA20 Analyzing 2 In the Show detail screen, results for each analyte can be selectively printed by checking the boxes. 3 Uncheck the Analyte you wish to exclude, and press the Print button.
Samsung LABGEO PA20 Analyzing 4 A print confirmation pop-up window appears on the display. Press the OK button to begin printing. 5 While the data is printing, the transfer status is shown. Ŷ The analysis results view is displayed again after printing.
Samsung LABGEO PA20 Analyzing Transferring results Results can be sent to PC application(LABGEO DATA MANAGER) and EMR/LIS. 1 Select the results you wish to transfer from the Results screen. Check the boxes next to the results you wish to transfer. t The device must be connected to a PC to transfer results. Please refer to page 133 for instructions on using the PC application. t Please refer to page 116 for instructions on setting the EMR/LIS.
Samsung LABGEO PA20 Analyzing 2 Press the Send button and select the transferring method. t If you select EMR/LIS, only results requested through EMR will be transferred. t To cancel the transfer, press the Cancel button. 3 62 If you select PC and the device is connected to a PC, the transfer will begin. If you select EMR/LIS and the device is connected to EMR, the transfer will begin. To cancel the transfer, press the Cancel button.
Samsung LABGEO PA20 Analyzing Deleting results 1 From the results screen, check the boxes next to the results you wish to delete and press the Delete button. 2 Press OK to begin deleting.
Samsung LABGEO PA20 Analyzing 3 Press Cancel to cancel deleting. Deleted results cannot be restored before you press the Cancel button.
Samsung LABGEO PA20 Analyzing Ŷ Quality control The QC menu is for checking whether the QC results are within a valid range. QC is performed according to the regulations of each analysis lab. QC materials can be registered in the Settings menu. Please refer to page 84 for instructions on registering QC materials. Starting quality control 1 Press the QC button on the home screen.
Samsung LABGEO PA20 Analyzing 2 When the pop-up window requests that you insert a disc, insert a disc into the tray. To cancel QC, press the Cancel button. 3 Select the QC material and press the OK button to begin QC.
Samsung LABGEO PA20 Analyzing 4 To cancel analysis, press the Cancel button. Once canceled, the disc cannot be used again. 5 Once QC completes, the result screen shown on the right is displayed. t If the device is connected to the LABGEO Data Manager, the analysis results are transferred automatically. t If auto-print is turned on, the analysis results are printed automatically. t To print the results, press the Print button. If the results are outside of QC range, is displayed.
Samsung LABGEO PA20 Analyzing 6 68 Press the Disc Out button and remove the disc.
Samsung LABGEO PA20 Analyzing Ŷ Analyzer settings (General User Settings) 1 Press the Setting button on the home screen. 2 General user settings: General user settings can be adjusted by anyone. After entering the Settings screen, the general user settings are displayed.
Samsung LABGEO PA20 Analyzing 3 70 Display Calibration, LCD brightness, screensaver, and LCD off settings can be adjusted. Volume Master volume, booting/ending sound, touch screen, warning/ error sound, and analysis completion sound can be adjusted. Analysis Unit of analytes, printing order, reference range, and QC materials can be adjusted. Peripherals Auto-print and starting point after barcode scanning can be adjusted. Language The analyzer language can be adjusted.
Samsung LABGEO PA20 Analyzing Ŷ Display settings Display settings consist of calibration, LCD brightness, screensaver, and LCD off settings. 1 Press the Setting button on the home screen. 2 Press the Display button. You can cancel any changes by pressing the Back button without pressing the OK button.
Samsung LABGEO PA20 Analyzing Calibration (touch screen calibration) Calibration is performed to adjust settings to improve recognition accuracy of the touch screen. 1 Select Calibration. 2 Press the center of the crosshairs (+) as they appear on the display to calibrate the touch screen recognition. t The crosshairs (+) turn blue after being selected. t If the touch screen recognition is not calibrated accurately after 2-3 calibrations, please contact Samsung Electronics Technical Support.
Samsung LABGEO PA20 Analyzing LCD Brightness The brightness of the LCD can be adjusted. The brightness can be adjusted in 5 levels. 1 Press 2 Press the OK button to set the brightness. You can cancel any changes by pressing the Back button without pressing the OK button. or for the LCD brightness.
Samsung LABGEO PA20 Analyzing Screensaver settings A screensaver is automatically activated after a set period of time to protect the analyzer’s LCD screen. The screensaver can be turned on or off, and the time for activating the screensaver can be adjusted. 1 Press or to select when the Screensaver starts. Never Ź 10 min Ź 20 min Ź 30 min Ź 1 hr. When set to Never, the screensaver is turned off. 2 74 The screensaver (a clock) is activated after the set amount of time has passed without use.
Samsung LABGEO PA20 Analyzing LCD Off settings The LCD Off function protects the analyzer’s LCD screen and saves power by turning the LCD off after a set period of time. 1 Press or to select when the LCD is to be turned Off. Never Ź 30 min Ź 1 hr Ź 2 hrs Ź 3 hrs. When set to Never, the LCD remains on. 2 The LCD turns off automatically after the set amount of time has passed without use.
Samsung LABGEO PA20 Analyzing Ŷ Volume settings 1 Press the Settings button on the home screen. 2 Press the Volume button. 3 Set each volume by pressing 4 Press the OK button to set the volume. Press the Back button to cancel. 76 or .
Samsung LABGEO PA20 Analyzing Ŷ Analysis settings Unit of analytes, printing order, reference range, and QC materials can be adjusted. 1 Press the Settings button on the home screen. 2 After pressing the Analysis button, select Units&Order, Reference Range, and QC Material.
Samsung LABGEO PA20 Analyzing Unit settings The units of analytes displayed in analysis results can be adjusted. 1 Press the Units&Order button. 2 SI and Non-SI (Conventional) can be chosen for each analyte. Check the box on the left to select SI or Non-SI for all analytes.
Samsung LABGEO PA20 Analyzing Conversion between SI and non-SI Units (Non-SI X Factor = SI) NO Abbr. Full Name Conventional Unit Conversion Factor SI Unit 1 ALT Alanine Aminotransferase U/L 1 U/L 2 AST Aspartate Aminotransferase U/L 1 U/L 3 CK Creatine kinase U/L 1 U/L 4 LD Lactate dehydrogenase U/L 1 U/L 5 BUN Blood Urea Nitrogen mg/dL 0.
Samsung LABGEO PA20 Analyzing Change order The order of analytes displayed when viewing analysis results can be adjusted. The changes affect the Results screen and print-outs. 1 Press the Units&Order button. 2 Press the Change Order button in the upper-left corner of the screen.
Samsung LABGEO PA20 Analyzing 3 Select Disc. 4 Select the analyte you wish to change the order of, make your changes by pressing the Up and Down buttons, then press the OK button.
Samsung LABGEO PA20 Analyzing Reference range settings The reference range of analytes can be adjusted. 1 82 Press the Reference Range button.
Samsung LABGEO PA20 Analyzing 2 Press the entry field of the analyte and a number pad appears on the screen. Enter a value for the analyte and press the OK button.
Samsung LABGEO PA20 Analyzing Ŷ QC material QC materials can be set. Registering QC Material 1 Press the QC Material button. 2 Press the Add button in the lower-right corner.
Samsung LABGEO PA20 Analyzing 3 To display the keypad, tap an empty field.
Samsung LABGEO PA20 Analyzing Ŷ Numeric Keypad 4 86 Select the analyte to add and press OK.
Samsung LABGEO PA20 Analyzing 5 To add the selected analyte, press the Add Analyte button. 6 To change the QC rules for the analyte, press the Yes button on the right.
Samsung LABGEO PA20 Analyzing 7 Set the rules and press the OK button. When none of the options have been selected, the minimum and maximum target range can be entered manually. The quality control policy should comply with the Westgard multi-rule. For more details, refer to Other information in Chapter 8. 8 88 Press the OK button after inputting the values. Press the OK button in the pop-up confirmation window, and QC material registration is completed.
Samsung LABGEO PA20 Analyzing Changing QC material 1 Press the QC Material button. 2 Select the Material to change.
Samsung LABGEO PA20 Analyzing 3 Change the material information. The name of the material, level, and Lot. No. cannot be changed. 4 Make changes and press the OK button. Press the OK button in the pop-up confirmation window to save your QC material changes.
Samsung LABGEO PA20 Analyzing Deleting QC material 1 Press the QC Material button. 2 Select a Material to delete.
Samsung LABGEO PA20 Analyzing 3 92 Press the OK button in the pop-up confirmation window to delete the QC material.
Samsung LABGEO PA20 Analyzing Ŷ Print settings Set the auto-print function to automatically print results when an analysis completes. 1 Press the Setting button on the home screen. 2 Press the Peripherals button.
Samsung LABGEO PA20 Analyzing 3 94 Press Print and set the Print Result. Manual The results are not printed automatically when the analysis is completed. To print a result, the user must select the Print button manually from the analysis completion screen or the analysis result viewing screen in the order list. Automatic Analysis results are printed automatically when the analysis completes and the printer is connected.
Samsung LABGEO PA20 Analyzing Ŷ Barcode settings Set the format of input values (Start Point, ID Length) when an ID is entered using a barcode reader. 1 Press the Setting button on the home screen. 2 Press the Peripherals button.
Samsung LABGEO PA20 Analyzing 3 Select the Barcode tab. 4 Set the barcode format (Start Point, ID Length). 96 Start Point Set a valid start point for analysis ID input by the barcode scanner. ID Length Set a valid ID length for analysis ID input by the barcode scanner.
Samsung LABGEO PA20 Analyzing Ŷ Language settings Select the language to be used by the analyzer. 1 Press the Setting button on the home screen. 2 Select the Language button.
Samsung LABGEO PA20 Analyzing 3 98 Select a language from English, Spanish, or Korean, and press the OK button. Press the Back button to cancel.
Samsung LABGEO PA20 Analyzing Ŷ Self-test Tests the hardware status of the analyzer. 1 Press the Setting button on the home screen. 2 Press the Self-Test button.
Samsung LABGEO PA20 Analyzing When performing a self-test without a disc, the home position, barcode and RFID are marked as N/A. 3 Press the Diagnosis button. A pop-up window prompts you for a disc to be inserted. Select Without Disc if you wish to perform the self-test without a disc.
Samsung LABGEO PA20 Analyzing 4 The Self-test runs. 5 A pop-up window prompts you to Remove the Disc when the self-test is completed.
Samsung LABGEO PA20 Analyzing 6 Check the self-test results. Press the Back button to go back to the previous screen.
Samsung LABGEO PA20 Analyzing Ŷ Analyzer settings (Administrator Settings) Enter the analyzer settings in administrator mode. 1 Press the Setting button on the home screen. 2 Press the Admin Login button.
Samsung LABGEO PA20 Analyzing 3 Enter a Password and press the OK button. (The factory default password is “0000”.) 4 The Lock, Network, Time, and System buttons are also displayed among the Settings options.
Samsung LABGEO PA20 Analyzing Ŷ Lock settings Analyzer functions can be locked and new password can be set. Setting security levels for each function 1 Press the Setting button on the home screen. Lock settings only appear in Admin Login mode. 2 Press the Security&Lockout button.
Samsung LABGEO PA20 Analyzing 3 Press the Lock button for the items you wish to lock with a password. You can view locked items after entering the password. 4 Press the OK button to save your changes. Press the Back button to cancel changes.
Samsung LABGEO PA20 Analyzing Locking quality control 1 Press the Setting button on the home screen. Security&Lock out settings only appear in Admin Login mode. 2 Press the Security&Lockout button.
Samsung LABGEO PA20 Analyzing 3 Select the Lockout tab. 4 Change the QC lock settings. If the lock feature is activated for QC, you cannot perform additional tests. Perform QC or deactivate the lock to test additional samples. If the QC lock is engaged for longer than a day without QC being performed, you cannot perform additional tests.
Samsung LABGEO PA20 Analyzing Changing password 1 Press the Setting button on the home screen. Password settings only appear in Admin Login mode. 2 Press the Security&Lockout button.
Samsung LABGEO PA20 Analyzing 3 To change the password, press the Change Password button. 4 Enter a password and press the OK button.
Samsung LABGEO PA20 Analyzing 5 Enter a new password in the Password and the Confirm password fields and press the OK button.
Samsung LABGEO PA20 Analyzing Ŷ Network settings Network selection, IP address, subnet mask, gateway, and DNS servers can be set in Network settings. (These settings are used to connect to the LABGEO Data Manager and EMR/LIS.) Connecting to a network 1 Press the Setting button on the home screen. Network settings only appear in Admin Login mode. 2 Press the Network button.
Samsung LABGEO PA20 Analyzing 3 Ethernet and wireless access point list is displayed. To connect the network, press button. t : The wireless AP needs the password to connect. t signal ( 4 ): The signal strength of wireless AP. Attempts to connect to the network. If the connection is successful, the button is changed .
Samsung LABGEO PA20 Analyzing Setting network connections 1 Select the network. 2 Select Auto or Manual.
Samsung LABGEO PA20 Analyzing 3 4 Enter IP Address, Subnet Mask, Gateway, and DNS Server information. IP Address Choose Auto if the IP address is automatically leased from a DHCP server, and Manual to specify an IP address manually. Subnet Mask Subnet mask can only be changed if the IP address is entered manually. The Factory default setting is 255.255.255.0. The subnet mask can be changed according to your network settings.
Samsung LABGEO PA20 Analyzing Setting EMR/LIS 1 Press the EMR/LIS button. 2 Select EMR/LIS protocol. 3 Enter the server IP address and port. 4 Press the OK button to save connection information and the analyzer can be access to EMR/LIS server program.
Samsung LABGEO PA20 Analyzing Ŷ Lock settings Select the time and date for the analyzer. 1 Press the Setting button on the home screen. Date&Time settings only appear in Admin Login mode. 2 Press the Date&Time button.
Samsung LABGEO PA20 Analyzing 3 Enter the date and time, then press the OK button. Press the Back button to cancel changes. The year can be chosen between 2000 and 2037. Enter HH:MM in 12-hour notation.
Samsung LABGEO PA20 Analyzing Ŷ Changing Date&time format Select the format of the date and time displayed by the analyzer. 1 Press the Setting button on the home screen. Date&Time settings only appear in Admin Login mode. 2 Press the Date&Time button.
Samsung LABGEO PA20 Analyzing 3 Select the Format tab. 4 Select display format by pressing or , then press the OK button. Press the Back button to cancel changes Display format options are as follows. Display formatting does not apply when setting the date. Date YYYY-MM-DD MM-DD-YYYY DD-MM-YYYY e.g.) 2012/10/31 e.g.) 2012/10/31 e.g.) 2012/10/31 Time 12 hour, 24 hour 120 Date Separator / , e.g.) 2012/10/31 e.g.) 2012-10-31 e.g.) 2012, 10, 31 Time Separator : e.g.) 12:30 PM . e.g.) 12.30 PM , e.g.
Samsung LABGEO PA20 Analyzing Ŷ System settings System information checks, updates, and initialization of the analyzer can be performed. 1 Press the Setting button on the home screen. System settings only appear in Admin Login mode. 2 Press the System button.
Samsung LABGEO PA20 Analyzing 3 Check the current system information.
Samsung LABGEO PA20 Analyzing System Reset Initializes the analyzer system. 1 To initialize the system to its factory defaults, press the Initialize button in the upper right corner of the display. 2 Enter the password for the analyzer.
Samsung LABGEO PA20 Analyzing 3 A pop-up window ‘Initialize the device now?’ prompts you to initialize the system. Select your initialization options and press the OK button. Delete all results: Only deletes analysis results. Delete all results and settings: Deletes all saved analysis results and all other settings. 4 Press the Yes button when a pop-up window prompts you to Confirm the initialization. Press the No button to cancel the initialization.
Samsung LABGEO PA20 Analyzing 5 When selecting Delete all results, the home screen is displayed when the initialization completes. When selecting Delete all results and settings, the analyzer reboots when the initialization completes. In this case, the touch screen must be calibrated and the Time and Date, password must be changed.
Samsung LABGEO PA20 Analyzing 126
Samsung LABGEO PA20 Analyzing USB Backup Saves the analysis results saved in the analyzer to a USB memory device. t QC results cannot be backed up. t Results backed up to a USB memory device can be transferred to a PC using the import function in the LABGEO Data Manager. 1 Press the USB Backup button in the lower-left corner of the system display. 2 Press the Yes button when a pop-up window prompts you to Confirm backup. You can check the Delete the internal memory after backup is complete.
Samsung LABGEO PA20 Analyzing 3 Press the Cancel button to cancel the USB backup. 4 When a pop-up window notifies you that the backup has completed, press the OK button, then remove the USB memory device.
Samsung LABGEO PA20 Analyzing System updates Updates the analyzer system. 1 Press the Update button in the lower-right corner of the system display. 2 The system can be updated using a PC, a USB memory device, or online. Select the desired update source. t PC, Internet: The analyzer must be connected to a LAN or USB cable.
Samsung LABGEO PA20 Analyzing 3 The analyzer reboots when the update completes. The system does not reboot when only the disc information(XML) has been updated.
Samsung LABGEO PA20 Analyzing Ŷ Turning off power 1 Press the power button on the right-hand side of the analyzer. 2 Press the OK button in the system shutdown confirmation pop-up window.
Samsung LABGEO PA20
Using the LABGEO Data Manager 5 Introduction to the LABGEO Data Manager .................................134 Installation of the LABGEO Data Manager ...................................135 Running the LABGEO Data Manager .............................................139 Home screen .......................................................................................140 Registering a blood analyzer device .......................................................................141 Viewing analysis results .
Using the LABGEO Data Manager Ŷ Introduction to the LABGEO Data Manager The LABGEO Data Manager connects to the blood analyzer, update server, and printer to provide an easy way to save the blood analyzer’s results, download the latest software updates, and print the analysis results. The features of the LABGEO Data Manager are as follows.
Samsung LABGEO PA20 Using the LABGEO Data Manager Ŷ Installation of the LABGEO Data Manager 1 Insert the installation CD into your computer’s CD/DVD drive; the LABGEO Data Manager installer should begin automatically. If the installation does not begin automatically, run LABGEOSetup.exe in the CD as an administrator (for Windows XP, select Open). 2 Select the language to install and click the Next button.
Samsung LABGEO PA20 Using the LABGEO Data Manager 3 Click the Next button. 4 Check “I agree to end-user license agreement” and click Next.
Samsung LABGEO PA20 Using the LABGEO Data Manager 5 Click Install to start installing the LABGEO Data Manager. 6 Installation begins.
Samsung LABGEO PA20 Using the LABGEO Data Manager When a pop-up window like the one below appears, select “Install this driver anyway” and proceed (in Windows XP, click Continue). 7 Click the Finish button when the installation is finished.
Samsung LABGEO PA20 Using the LABGEO Data Manager Ŷ Running the LABGEO Data Manager 1 Run the LABGEO Data Manager from the shortcut in the desktop or under (All) Programs in the Start Menu. 2 When the program runs, a window for creating a new account is displayed. Enter your ID and a 6 to 12 character password using a combination of letters and numbers, then click the “Add” button. The message, “New account has been added,” is displayed and the program begins.
Samsung LABGEO PA20 Using the LABGEO Data Manager Ŷ Home screen This is the home screen of the LABGEO Data Manager. a d b c e a. Menu bar b. Dropdown selector for results viewing categories: View results for all patients, Only view results without patient information, View QC results (Old), View QC results (New) c. Results list d. Search results menu e. Shortcut buttons f.
Samsung LABGEO PA20 Using the LABGEO Data Manager Registering a blood analyzer device 1 Select “Blood Analyzer Administrator” under the Tools menu. Select the connection type and click the Next button. Local (USB) Choose when the blood analyzer is connected to the PC by a USB cable. Network (LAN) Choose when the analyzer and the PC are connected to the same local area network Input IP address (LAN) Choose when connecting to the analyzer by manually entering the IP address.
Samsung LABGEO PA20 Using the LABGEO Data Manager USB connection settings t When the analyzer is connected to the PC by a USB cable, the following settings are required. a. Select “USB Connection Settings” under the Tools menu. b. Select the model number of the connected blood analyzer, select the adapter connected to the analyzer, and click Apply. If connecting the analyzer via USB does not work, remove the Linux USB Ethernet/RNDIS gadget via the Device Manager (in the Control panel).
Samsung LABGEO PA20 Using the LABGEO Data Manager 2 Click the Next button and a list of available blood analyzers is displayed. Select the blood analyzer to connect with and click Next.
Samsung LABGEO PA20 Using the LABGEO Data Manager If the analyzer does not appear on the list, check the connection between the analyzer and the PC. If the firewall is activated, register LABGEO.exe (as an exception) and try again. 3 When entering an IP address, enter the IP address of the analyzer you wish to connect to see a connection screen similar to .
Samsung LABGEO PA20 Using the LABGEO Data Manager 4 Select the password for the blood analyzer you wish to connect to, designate a letter for identification, and click “Register”.
Samsung LABGEO PA20 Using the LABGEO Data Manager 5 When registration is completed, a list of registered analyzers is displayed, as shown in the figure below. You can use the “Add”, “Delete” and “Refresh” buttons to add, delete or update the connection status of blood analyzers.
Samsung LABGEO PA20 Using the LABGEO Data Manager Ŷ Viewing analysis results You can view the results by double-clicking on the result you wish to view from the analysis results list or select a result and click on the View button. You can sort the analysis results by clicking on the name of each analyte. An analysis results list shows up to 100 results in a single page.
Samsung LABGEO PA20 Using the LABGEO Data Manager Ŷ Editing analysis results 1 To edit one analysis result, select the result and then click on the Edit button on the bottom or click on the Edit Patient Information Tab in the analysis result view screen.
Samsung LABGEO PA20 Using the LABGEO Data Manager 2 To edit multiple analysis results, switch to multiple-edit mode by clicking Edit > Multiple-Edit Mode in the menu or switch the multiple-edit mode on in the upperright corner of the screen to edit the list like a spreadsheet. When editing patient information, chart number and patient name are required information.
Samsung LABGEO PA20 Using the LABGEO Data Manager Selecting and editing multiple analysis results 1 Hold down Ctrl and click individual analysis results you wish to select. Hold down Shift and click to select a group of analysis results. 2 You can also select multiple analysis results by clicking one result, and dragging the cursor.
Samsung LABGEO PA20 Using the LABGEO Data Manager Ŷ Printing analysis results Entering hospital information and insurance codes 1 Hospital information and insurance codes can be added and modified under the Tools > Customization menu.
Samsung LABGEO PA20 Using the LABGEO Data Manager 2 To print the selected results, click the Print button at the bottom or click File > Print in the menu. 3 By clicking File > Print Options in the menu, you can select analytes to include when printing by panel. t By checking Auto-print under File > Print Options, the software automatically prints any new analysis result received from the blood analyzer.
Samsung LABGEO PA20 Using the LABGEO Data Manager Ŷ Removing the LABGEO Data Manager 1 Caution: You must close the program before uninstalling it. Uninstalling the program also erases all the program’s data stored on the PC. 2 To uninstall the LABGEO Data Manager, run LABGEOSetup.exe in the installation CD or go to Control Panel > Add/remove Programs, select the LABGEO Data Manager, and click Remove. When the software uninstallation begins, the following screen is displayed.
Samsung LABGEO PA20 Using the LABGEO Data Manager 3 Click Yes when you see the pop-up as below. 4 Click the Complete button when the uninstallation of the LABGEO Data Manager is completed.
6 Maintenance Maintenance.......................................................................................156 Maintenance ....................................................................................................................156 Cleaning the exterior ....................................................................................................156 Cleaning the Disc Tray ..................................................................................................
Maintenance Ŷ Maintenance No maintenance of the Samsung LABGEOPA20 is required other than cleaning the exterior and disc tray. Maintenance Ŷ Check the analyzer on a regular basis even when it works properly. If you find a problem with the analyzer, stop operating it and contact Samsung Technical Support. Ŷ Clean the analyzer on a regular basis. Cleaning the exterior Cleaning the exterior of the Samsung LABGEOPA20 should be performed whenever necessary.
Samsung LABGEO PA20 Maintenance Cleaning the Disc Tray Ŷ To clean or disinfect the disc tray, tap “Run” on the home screen to open the tray and follow the instructions above. Transportation and Storage Ŷ Do not move the analyzer while the disc is being analyzed. Please be careful with physical impact or vibration when transportation when moving the analyzer. Ŷ The main body should be cleaned up.
Samsung LABGEO PA20
7 Troubleshooting Troubleshooting ................................................................................160 Check before requesting repair ................................................................................160 Restoring factory settings ...........................................................................................160 Error List ..............................................................................................
Troubleshooting Ŷ Troubleshooting Check before requesting repair Ŷ The power switches of the blood analyzer are located on the front and back of the device. The front power switch only responds when the rear power switch is turned on. Please make sure that the rear power switch is turned on fi rst. Ŷ If the power still doesn’t turn on, contact Samsung Electronics Technical Support.
Samsung LABGEO PA20 Ŷ Error List Error Code Message Problem Solution 202001B Setting Error Unable to save settings after making changes. Contact Technical Support. Lack of Storage Space Error Insufficient storage space. Backup analysis results on the device to a USB memory device or a PC, then delete the results from the analyzer. 203002C System Error USB memory device is not compatible or shows a file error in the drive.
Samsung LABGEO PA20 Error Code Message Problem Solution 205102B Data Transfer Error Connection to the PC has connection errors. Check your network connections. 205202B Data Transfer Error Connection to the EMR has connection errors. Check your network connections. 206001A Barcode Read Error The barcode on the disc is contaminated. Try again after replacing the contaminated disc with a new one. 206002A Barcode Error The disc is not for the blood analyzer.
Samsung LABGEO PA20 Error Code Message Problem Solution Out of USB storage space Insufficient space on the external USB memory device connected for backing up data from the analyzer. Delete the files on the USB memory device or use a new USB memory device. USB is Locked The external USB memory device connected to the analyzer is writeprotected. Make sure that the write-protection on the USB memory device is unlocked.
Samsung LABGEO PA20
8 Other Information Quaility control policy ......................................................................166 Westgard multi-rule technique .................................................................................166 System information...........................................................................167 Other information .............................................................................168 Product Service ..................................................................
Other information Ŷ Quaility control policy Westgard multi-rule technique Ŷ Levey-Jenning Approach 1:2S Warning rule: 1 control outside 2SD and 1 control within 2SD. 1:3S Rejection rule (random error): 1 of the controls is outside 3SD. 2:2S Rejection rule (systematic error): 2 consecutive controls are outside 2Sd. The problem should be corrected before running the control again.
Samsung LABGEO PA20 Ŷ System information Category Item Specifications ARM CortexTM-A8 1GHz CPU/Embedded Linux Processor/OS NAND 512MB x 8bit x 1ea (2Gbit) SDRAM 64MB x 16bit x 4ea (2Gbit) Display 7 inch wide, 800 x 480, TFT LCD Touch 7 inch 4-wire panel LED Power Status Key Power, Stop Printer Built-in Thermal Printer (2 inch) Thermal Paper (recommended) HANSOL PAPER 65GSM Paper width (58mm, 2.36’’) Paper roll size : max. 40mm (1.
Samsung LABGEO PA20 Category Item Specifications Type of Installation For Indoor use only Humidity Operating : 0% to 80% Storage & Shipping : 0% to 80% Altitude Operating : 3,048m Storage & Shipping : 10,668m Notes Ŷ Other information Medical Device Name Clinical Chemistry and Immunology Analyzer Model Name Samsung LABGEO PA20 Manufacturer and Address Samsung Electronics Co., Ltd., 129 Samsung-ro, Yeongtong-gu, Suwon-si, Gyeonggi-do Operating System 2.6.32.
Samsung LABGEO PA20 Ŷ Product Service Samsung Electronics Co., Ltd. 129 Samsung-ro, Yeongtong-gu, Suwon-si, Gyeonggi-do Please contact your retailer for service inquiries. License Notification The complete text of the license can be seen in the License.pdf file under the PA20 folder in the installation CD.
Samsung LABGEO PA20 Ŷ Index B I Backup 127 ID 55, 56, 95 Beginning analysis 36 Initialization 123 Installation 25 C Intended use 18 Calibration 72 Introduction of features 23 Canceling analysis 43 Cautions before analyzing 12 L Cautions during use 13 LABGEO Data Manager 133 Cautions for system LCD Brightness 73 installation 14 LCD Off settings 75 Cautions in preparing blood samples 14 P Change language 97 Preheating 36 Changing password 109 Preparing blood for Check before requesting
Samsung LABGEO PA20 S T Safety Warnings and Trouble shooting 159 Caution 8 Touch calibration 72 Screensaver settings 74 Transferring analysis results 61 Searching results 54 Turning power off 131 Security 105 Turning power on 36 Self-test 99 Setting auto-mode 114 U Setting date and time 117 Update 129 Setting network 112 User setting screen 103 Setting viewing method 80 Setting volume 76 V Viewing results 47 Storage and maintenance after use 156 System information 167 System settings 121
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HM68-01006C/2012-07
