Samsung Electronics Co LABGEOPA20 Immunology Analyser User Manual

Samsung Electronics Co Ltd Immunology Analyser

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LABGEOPA20 User Manual

Users Manual

For proper use of the analyzer, please refer to the product manual.PA20User ManualVersion 1.0IVD 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.comBCA-PA20

2 Copyright© Copyright Reserved 2012 Samsung Electronics Co., LtdThe 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 specications of this user manual are subject to change without prior notice.Correct Disposal of This Product (Waste Electrical & Electronic Equipment) (Applicable in countries with separate collection systems)This marking on the product, accessories or literature indicates that the product and its electronic accessories (e.g. charger, headset, USB cable) should not be disposed of with other household waste at the end of their working life. To prevent possible harm to the environment or human health from uncontrolled waste disposal, please separate these items from other types of waste and recycle them responsibly to promote the sustainable reuse of material resources. Household users should contact either the retailer where they purchased this product, or their local government oce, for details of where and how they can take these items for environmentally safe recycling. Business users should contact their supplier and check the terms and conditions of the purchase contract. This product and its electronic accessories should not be mixed with other commercial wastes for disposal.

31. Safety Warnings and Caution ........................7User’s Manual and Labeled Symbols ................................. 9Cautions for system installation ....................................... 11Cautions for system move ................................................. 12Cautions before use ............................................................ 12Cautions during use ............................................................ 13Precautions Before Testing ................................................ 14Preparing to Test Samples .........................................................................14Cautions for storage and maintenance after use .......... 152. Introduction .................................................17Intended Use ........................................................................ 18Introduction ......................................................................... 19Operating Principle ............................................................. 20What’s in the box ................................................................. 20Box contents...................................................................................................20Sold separately ..............................................................................................21Introduction of features ..................................................... 22Front (Right) ...................................................................................................22Front (Left) ......................................................................................................23Back ...................................................................................................................243. Installation ....................................................25Installation ............................................................................ 26Replacing printer paper ..................................................... 27 Table of Contents

4Samsung LABGEO PA20 Table of ContentsDisc ......................................................................................... 29Handling and Storage of the Disc .................................... 30Adding the sample to the Disc .......................................... 314. Analyzing ......................................................35Analyzing .............................................................................. 36Turning power on .........................................................................................36Preparing analysis ........................................................................................40Canceling analysis in progress ................................................................43Analysis completed ....................................................................................45Viewing analysis results .............................................................................47Viewing results ..................................................................... 48Viewing results of patient’s analysis ......................................................50Viewing QC results .......................................................................................52Searching results ..........................................................................................54Printing results ..............................................................................................56Transferring results ......................................................................................61Deleting results .............................................................................................63Quality control ..................................................................... 65Starting quality control ..............................................................................65Analyzer settings (General User Settings) ...................... 69Display settings ................................................................... 71Calibration (touch screen calibration) ..................................................72LCD Brightness .............................................................................................73Screensaver settings....................................................................................74LCD O settings ...........................................................................................75Volume settings .................................................................. 76Analysis settings ................................................................. 77Unit settings ...................................................................................................78Change order .................................................................................................80Reference range settings ..........................................................................82

5Samsung LABGEO PA20 Table of ContentsQC material ........................................................................... 84Registering QC Material .............................................................................84Changing QC material ...............................................................................89Deleting QC material ..................................................................................91Print settings ........................................................................ 93Barcode settings .................................................................95Language settings .............................................................. 97Self-test ................................................................................. 99Analyzer settings (Administrator Settings) ..................103Lock settings ......................................................................105Setting security levels for each function ........................................... 105Locking quality control ..........................................................................107Changing password ................................................................................. 109Network settings ...............................................................112Connecting to a network ........................................................................ 112Setting network connections ..............................................................114Setting EMR/LIS .......................................................................................... 116Lock settings.......................................................................117Changing Date&time format ..........................................119System settings .................................................................121System Reset .............................................................................................. 123USB Backup ................................................................................................. 127System updates ......................................................................................... 129Turning o power ..............................................................1315. Using the LABGEO Data Manager .............133Introduction to the LABGEO Data Manager .................134Installation of the LABGEO Data Manager ...................135

6Samsung LABGEO PA20 Table of ContentsRunning the LABGEO Data Manager .............................139Home screen .......................................................................140Registering a blood analyzer device ..................................................141Viewing analysis results ...................................................147Editing analysis results .....................................................148Selecting and editing multiple analysis results .............................. 150Printing analysis results ...................................................151Removing the LABGEO Data Manager ..........................1536. Maintenance ...............................................155Maintenance .......................................................................156Maintenance ...............................................................................................156Cleaning the exterior ...............................................................................156Cleaning the Disc Tray .............................................................................157Transportation and Storage...................................................................1577. Troubleshooting .........................................159Troubleshooting ................................................................160Check before requesting repair ............................................................ 160Restoring factory settings ......................................................................160Error List ..............................................................................1618. Other Information ......................................165Quaility control policy ......................................................166Westgard multi-rule technique ............................................................ 166System information ...........................................................167Other information .............................................................168Product Service ..................................................................169Index ....................................................................................170

Safety Warnings and Caution1User’s Manual and Labeled Symbols ................................................. 9Cautions for system installation ....................................................... 11Cautions for system move ................................................................. 12Cautions before use ............................................................................ 12Cautions during use ............................................................................ 13Precautions Before Testing ................................................................ 14Preparing to Test Samples ............................................................................................. 14Cautions for storage and maintenance after use .......................... 15

8 Safety Warnings and CautionPlease 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.Malfunctions and damage caused by any other use than specied in the User Manual is excluded from the manufacturer’s warranty.If the equipment is used in a manner not specied by the manufacturer, the protection provided by the equipment may be impaired.

9Samsung LABGEO PA20 Safety Warnings and Caution ŶUser’s Manual and Labeled SymbolsSymbol ExplanationBiohazard. 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.Temperature limitation/ Allowed Temperature Range Shows temperature limit for storage or transportFragile/Fragile contents; handle with careKeep dry/Package should avoid wettingThis way upLoading Unit/Avoid loading more than the marked number of unitsIn Vitro diagnostic deviceSerial numberManufacturerUSB portEthernet port

10Samsung LABGEO PA20 Safety Warnings and CautionSymbol Explanation‘New’ waste The bar can be replaced by the date of manufactureCatalog numberNorth American Safety Certication MarkAlternating currentPower OnPower OHot SurfaceRisk of electronic shockStand-by switchLASER CLASSIFICATION This Clinical Chemistry and Immunology Analyzer is conrmed as the class 1 laser product in IEC60825-1:2007- Wavelength: 808 nm- Maximum output of laser radiation: Max. 1.5 W

11Samsung LABGEO PA20 Safety Warnings and Caution ŶCautions for system installation ŶKeep the analyzer at least 6 inches (15cm) away from any wall to provide adequate ventilation and prevent overheating. ŶBe careful not to expose the analyzer to sources of vibration such as placing it near a centrifuge. ŶDo not use the analyzer where liquids or chemicals are used or where gas may be produced. Insure that no liquids are spilled into the Unit if there is any spillage disconnect mains immediately and return to product for serving. ŶThe analyzer must be used at an operating temperature of 10 - 32 °C (50- 89 °F). The analyzer might be aected by:t Condensing humidity and watert Heat and extreme temperature variationst Electromagnetic radiationt Movement of the analyzer during sample processing ŶOnly use the cable provided with the analyzer. ŶTo avoid risk of re or electric shock, do not use a damaged power cable. ŶAlways use the correct voltage supply. Incorrect voltage can cause damage to the analyzer or result in re. Be sure that the electrical outlet is properly grounded. ŶDo not attempt to disassemble, repair or modify the analyzer as damage could occur. Opening the unit will void the warranty. Contact Samsung Technical Support. ŶDo not place any objects on the analyzer. ŶDo not cover the rear ventilation panel. This may damage the internal parts, resulting in a re or electric shock. ŶDo not introduce foreign substances into the servicing hole. ŶTurn on the power switch at the rear of the Analyzer. (Grounding Proper grounding is required when installing the system. Check the wall outlet ground (Earth) for proper grounding to the facilities electrical ground. If you are unsure of the outlet grounding, contact your facilities engineer to verify the proper outlet ground). Next, turn the power switch on the front of the Analyzer on and check that the program starts normally. ŶDo not touch the power plug with wet hands. This may result in an electric shock.

12Samsung LABGEO PA20 Safety Warnings and Caution ŶCautions for system move ŶDropping the product while moving or carrying may cause damage to the product. ŶBe careful of impact when moving the product at all times. ŶWhen moving the product by car, please use the original packaging material.When moving the analyzer, rst turn o the power and disconnect the power cable from the product. ŶCautions before use ŶWhen the blood is not used immediately, be sure to store it appropriately to prevent it from contamination. ŶCheck for dust or other impurities on a regular basis. ŶAlways install the product in a well-ventilated, clean, and dry area. ŶKeep the product away from heat-emitting products (such as heaters). It may cause deformation of the product, re, or adversely inuence analysis results.

13Samsung LABGEO PA20 Safety Warnings and Caution ŶCautions during use ŶThis system is for professional use only. The user must be a physician, clinical laboratory personnel, or healthcare professionals. ŶAvoid external shock or vibration during analysis. ŶDo not use expired discs. ŶDo 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. ŶThe Analyzer contains UV/Visible LED Light source and laser. The users are not exposed to Optical radiation in normal conditions. Because it is blocked with analyzer cover cabinet. Do not open the tray during analysis. Do not look into the analyzer during analysis. Your vision will be damaged due to UV-lamp. ŶPowder-free gloves must be worn when operating the product. ŶDo not move the analyzer during operation. ŶWhen inserting a disc into the tray, check the orientation of the disc. It must be inserted with the label side up. Consult test Instructions for Use. ŶAlways use designated power cable. Do not unplug the device in the middle of an analysis. ŶIf the product produces smoke or strange odors, discontinue use, unplug the power cord from the outlet, and contact your local distributor for service information. ŶIf operation has been aborted due to abnormal circumstances such as a power outage during operation, discard the disc and start over with a new disc. ŶDo not turn o the power during analysis. Press Cancel to abort a test if needed. Discard the disc and start over with a new disc. ŶBe careful not to damage the barcode on the disc. If the barcode is damaged, the test will not perform accurately. ŶDo not use the analyzer where liquids or chemicals are used or where gas may be produced. ŶDo not allow liquid to spill into the analyzer. If there is any spillage, disconnect power immediately and contact your local distributor. ŶIf you wish to stop the analysis in progress without turning the analyzer o , press the Cancel button and stop the analysis. After stopping an analysis in progress, throw away the cartridge and replace it with a new one. ŶThe operating temperature of the analyzer is 10 - 32 °C (50 - 89 °F); the analyzer automatically maintains an internal temperature of 37°C. (The device shuts o automatically if it exceeds normal operating temperature.)

14Samsung LABGEO PA20 Safety Warnings and Caution ŶPrecautions Before TestingPreparing to Test Samples1 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.Inlet4 Inject into the inlet shown in the gure above as described in the Test Instructions for Use.Refer to the Test Instructions for Use for the correct sample volume to be injected into the disc.

15Samsung LABGEO PA20 Safety Warnings and Caution ŶCautions for storage and maintenance after use ŶDo not store the product in humid areas or areas inuenced by temperature, humidity or wind. ŶStore the device on a at surface and keep it away from vibration or impact. ŶDo not store the product with chemicals or gas. ŶOperating conditions and temperature: 10 - 32 °C (50 - 89 °F), Humidity: 0% - 80% ŶStorage conditions and temperature: -10°C - +40°C , Humidity: 0% - 80% ŶIf there is blood residue from a specimen or any contaminants in the disc tray and the interior or exterior of the analyzer, remove the contaminant using a soft cloth while wearing gloves.Wet the cloth using 30% isopropyl alcohol when removing contaminants.Do not use highly corrosive agents such as benzene or acetone.These agents may damage the analyzer. ŶWhen moving or transporting the product, follow the conditions for using and storing the product specied in this manual. Follow all cautions when moving the product. ŶA specimen may be contaminated with pathogens or viruses that cause infectious illnesses such as Hepatitis B. All specimens must be considered and handled as potential contaminants. ŶUsed discs must be processed using Medical Waste Treatment Laws after use.

Introduction2Intended Use ........................................................................................ 18Introduction ......................................................................................... 19Operating Principle ............................................................................. 20What’s in the box ................................................................................. 20Box contents ...................................................................................................................... 20Sold separately .................................................................................................................. 21Introduction of features ..................................................................... 22Front (Right) ....................................................................................................................... 22Front (Left) .......................................................................................................................... 23Back ....................................................................................................................................... 24

18 Introduction ŶIntended UseThe 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 buers for a complete test. The Analyzer unit contains the Laser which is for controlling microuidics. UV LED is light source is for detection chemical reaction.For use in moderate complexity labs with whole blood, plasma or serum.If the Samsung LABGEOPA20 is used in any way other than described in this manual, the analyzer may not operate as intended, may produce inaccurate or no results, and may pose a safety harzard.Use only Samsung LABGEOPA20 reagent disc with the Samsung LABGEOPA20.

19Samsung LABGEO PA20 Introduction ŶIntroductionThe 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 microuidics makes the total process of plasma separation, metering, mixing, incubation, washing, and detection fully automatic.A lithium-heparinized whole blood, plasma, or serum sample of 450uL is applied directly to a disposable reagent disc and the disc is inserted into the analyzer by an operator. Each reagent disc is self-contained clear plastic with diameter of 12 cm and thickness of 0.8 cm, which consists of dierent kinds of reagents and buers.The entire process is activated once the operator touches the “Run” button on the display. The ‘self-test’ function is initiated, whereby the main power, main motor, laser motor, temperature IC, photometer, laser, heater and barcode reader are checked. The ‘self-test’ function is conducted automatically before each test or control run. This built-in self testing function minimizes maintenance costs. After inserting a reagent disc into a tray, the analyzer automatically detects the disc type and identies the clinical chemistry and immunoassay tests before performing the assays. The analysis is completed in about 12 to 25 minutes depending on the disc type.The results are displayed on the LCD screen along with the reference ranges, can be printed out by an internal thermal printer, and can be transferred to a laboratory information system and electronic medical record systems (LIS/EMR) via an Ethernet and wireless LAN ports. Data storage is up to 5,000 patient results and 3,000 control results in the instrument.The system provides user-friendly and easy interface for analysis that minimizes user manipulation. Handy compact design (246(W) x 375(D) x 289(H) mm3) allows maximized space utilization and the light weight (~ 9.2 kg) provides portability.Compared to conventional blood analyses done in clinical laboratories, the analyzer system is suitable for point-of-care applications because it requires a smaller amount of blood takes less time, and does not require specially trained operators, or expensive instruments to run biochemical assays and immunoassays separately.

20Samsung LABGEO PA20 Introduction ŶOperating PrincipleThe analyzer is equipped with two optical detection modules. One is a photometer and the other is a uorometer. The photometer can measure absorbance at 10 dierent 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.For endpoint reactions, the nal absorbance is used for the calculation of the concentration of the analyte.For kinetic reactions, the absorbance change during a predetermined time is utilized for the calculation of the concentration instead of the nal absorbance.The uorometer utilizes a time-resolved uorescence method to support high-sensitivity immunoassay based on europium nanoparticle lables. A 365 nm LED is used as an excitation light source and a red-sensitive photomultiplier tube is used as a photodetector. The measured uorescence intensity is converted into the concentration of the anlayte. ŶWhat’s in the boxBox contentsAnalyzer Samsung LABGEO PA20BCA-PA20Power CableA 1.8m long cable used to supply power to the system. The eective voltage range is between 100-240 VAC (50-60Hz).Printer paper USB Cable

21Samsung LABGEO PA20 IntroductionUser Manual Software installation CDSold separately Pipette tipsDisc Control SerumBarcode 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.

22Samsung LABGEO PA20 Introduction ŶIntroduction of featuresFront (Right)6245178931. Main Unit2. Printer3. Printer feed button4. 7-inch Color TFT LCD Monitor5. Tray6. Power Button: Used to turn the analyzer on or o7. USB Port: Used to update the software and to back up the analysis results in the USB memory8. Servicing Hole: For qualied Samsung Technical Support personnel only9. HOT SURFACE label

23Samsung LABGEO PA20 IntroductionFront (Left)211. Class 1 laser product label2. Monitor tilting button

24Samsung LABGEO PA20 Back5234167891. Power Switch: Used to turn the power to the analyzer on or o, turning o this switch completely cuts the power o.2. Power Input: Connect the Power Cable here3. USB Port : Used to update the software and to back up. The smaller port is provided for connecting to a computer4. Ethernet Port : Used to connect to LAN or the Internet5. Cooling Fan6. Biological Hazard Warning7. Displays basic information of the analyzer including product name, manufacturer, manufactured date and serial number8. Motor Cover: To be removed for maintenance and only by authorized Samsung Technical Support personnel9. Speaker

Installation3Installation ............................................................................................ 26Replacing printer paper ..................................................................... 27Disc ......................................................................................................... 29Handling and Storage of the Disc .................................................... 30Adding the sample to the Disc .......................................................... 31

26 Installation ŶInstallation1 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.3 Connect the power cable to the power input on the rear panel of the analyzer.4 Plug the power cable into the AC power outlet. The analyzer uses a switching-mode power supply (100-240 V).5 LAN and USB cables are used for PC software (LABGEO Data Manager) connections.

27Samsung LABGEO PA20 Installation ŶReplacing printer paper1 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 conrm that the paper comes out through the front of the printer while holding the leading edge.

28Samsung LABGEO PA20 Installation5 Close the lid and conrm that the paper is positioned between the lid and the front of the printer.

29Samsung LABGEO PA20 Installation ŶDiscThe actual disc may dier from the images shown below.12431. Sample injection Hole2. Reagent3. Disc Barcode4. Detection area (gray-colored zone)Care must be taken to keep the detection area clear of ngerprints or other foreign substances.Contamination of the detection area may aect the analysis results.

30Samsung LABGEO PA20 Installation ŶHandling and Storage of the DiscHandle 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. The analyzer detects and rejects a disc that has expired.t Bring the disc in its unopened pouch to room temperature (18 - 25 °C or 64 - 77 °F) for at least 10 minutes before using it on the analyzer.t The disc can be left at room temperate (18 - 25 °C or 64 - 77 °F) for a total of up to 12 hours if the pouch remains sealed. Do not use the disc if left at room temperature more than 12 hours.t Do not expose the open disc to direct sunlight.t Do not expose the disc to temperatures over 32 °C (89 °F).t Do not use a disc if the pouch is cut or torn as the reagents inside may be damaged by moisture.t Tear open the pouch at the notch located at the top edge. Once the pouch is opened, the disc must be used within approximately 10 minutes or discarded. It cannot be put back in the refrigerator for use at a later time.t Be careful not to leave ngerprints or other contaminants in the detection areas of the disc.t Keep the disc level at all times! BIOHAZARD! Operator health and safety regulations require that Universal Precautions are to be observed whenever handling human blood samples or working with the Samsung LABGEOPA20. For additional information refer to OSHA 29 CFR Part 1910, Standard number 1910.1030 (Toxic and Hazardous Substances: Bloodborne Pathogens”). This can be found on the internet at http://www.osha.gov and going to “1910.1030.” Used discs contain human blood. Care must be taken in handling used discs as the blood may have been infected by microbes that may cause infectious diseases such as hepatitis B. The disc, once used, should be disposed of according to medical waste disposal rules.For additional guidelines on handling and disposing of hazardous medical wastes, refer to “Clinical Laboratory Waste Management, Approved Guideline—Second Edition (GPS-A2) issued by the Clinical and Laboratory Standards Institute (previously known as NCCLS). This can be found at http://clsi.org.

31Samsung LABGEO PA20 Installation ŶAdding the sample to the DiscIt is advisable to power up the instrument prior to loading the sample on the disc. See page xx. ŶBring 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. Do not use a disc that has been dropped. Inspect every disc for damage before use. Never use a damaged disc. ŶUse a pipette to inject 450 µL into the sample injection hole. The disc requires a minimum of 450 µL, maximum of 750 µL. Slowly inject the blood sample into the disc through the sample injection hole.Be careful not to pipette with excessive force or pull back on the plunger when removing the pipette from the hole. Be careful not to inject a bubble into the sample injection hole.

32Samsung LABGEO PA20 Installation ŶSAMPLE INJECTIONt Correct injection volumet Insucient sample volumeAnalyzer will show message that insucient sample has been injected. Carefully pipette an additional 100 µL ~ 250 µL into the sample injection hole. Tap Retry on analyzer.

33Samsung LABGEO PA20 Installationt Excessive sample injectionDuring analysis, any surplus sample will move into the overow chamber as shown below:(surplus sample ĺ overow sample chamber)Injecting more than 750 L may cause sample chamber to overow. ŶDo not use expired discs. ŶBe careful to insert the disc into the analyzer properly. When inserting the disc the blood sample hole should be facing up.

Analyzing4Analyzing .................................... 36Turning power on ................................. 36Preparing analysis ................................. 40Canceling analysis in progress ........ 43Analysis completed ............................. 45Viewing analysis results ...................... 47Viewing results ........................... 48Viewing results of patient’s analysis ..................................................... 50Viewing QC results ............................... 52Searching results ................................... 54Printing results ....................................... 56Transferring results ............................... 61Deleting results ..................................... 63Quality control ........................... 65Starting quality control ....................... 65Analyzer settings (General User Settings) ............. 69Display settings ......................... 71Calibration (touch screen calibration) .................. 72LCD Brightness ...................................... 73Screensaver settings ............................ 74LCD O settings .................................... 75Volume settings ........................ 76Analysis settings .......................77Unit settings ........................................... 78Change order ......................................... 80Reference range settings .................. 82QC material ................................. 84Registering QC Material ...................... 84Changing QC material ........................ 89Deleting QC material .......................... 91Print settings .............................. 93Barcode settings .......................95Language settings .................... 97Self-test ....................................... 99Analyzer settings (Administrator Settings) .........103Lock settings ............................105Setting security levels for each function .................................................. 105Locking quality control ....................107Changing password ..........................109Network settings .....................112Connecting to a network .................112Setting network connections ........114Setting EMR/LIS ...................................116Lock settings.............................117Changing Date&time format .......................................119System settings .......................121System Reset .......................................123USB Backup ..........................................127System updates ..................................129Turning o power ....................131

36 Analyzing ŶAnalyzingTurning power on1 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”.

37Samsung LABGEO PA20 Analyzing2 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.

38Samsung LABGEO PA20 Analyzing2. Analysis Information: Select Run menu to enter analysis information and perform blood analysis.3. QC Run: This is the start menu of QC Run.

39Samsung LABGEO PA20 Analyzing4. 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.

40Samsung LABGEO PA20 AnalyzingPreparing analysis1 Press the Run button. ŶUp 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 eld.t You may enter the Patient ID by scanning a barcode with the barcode scanner.

41Samsung LABGEO PA20 Analyzing3 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.

42Samsung LABGEO PA20 Analyzing4 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.

43Samsung LABGEO PA20 AnalyzingCanceling analysis in progress 1 To cancel a test for Disc Validity Check or during the blood analysis stage, press the Cancel button.

44Samsung LABGEO PA20 Analyzing2 Press the Yes button to cancel, and the No button to resume the analysis. ŶWhen an analysis in progress is canceled, the disc cannot be used again.

45Samsung LABGEO PA20 AnalyzingAnalysis completed 1 When the analysis is completed, an audio notication 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. 9For instructions on adjusting auto-print settings, please refer to “Settings–Peripherals” (page 93).t If the device is connected to a PC, the analysis results are automatically transmitted to the PC application(LABGEO DATA MANAGER) upon completion. 9For more details on the PC software (LABGEO Data Manager), please refer to page 133.t If the EMR/LIS settings are correctly set, the analysis results are automatically transmitted to the EMR/LIS server program. 9Please refer to page 116 for instructions on setting the EMR/LIS.GlossaryHEM (Hemolysis) Specimen’s level of hematolysisLIP (Lipemia) Specimen’s level of lipemiaICT (Icterus) Specimen’s level of icterus

46Samsung LABGEO PA20 AnalyzingThe 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 rangeWhen QC failsTip The audio notication for completion of the test can be adjusted. To adjust the volume, please refer to Settings – Volume (page 76).2 Press the button to remove disc from the open tray.

47Samsung LABGEO PA20 AnalyzingViewing analysis results1 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.

48Samsung LABGEO PA20 Analyzing ŶViewing resultsPress the Result button on the home screen to display the Results.Results are grouped by All, Patient and Material QC. ŶAll ŶPatient

49Samsung LABGEO PA20 Analyzing ŶQuality Control

50Samsung LABGEO PA20 AnalyzingViewing results of patient’s analysis1 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 upper-right corner.

51Samsung LABGEO PA20 Analyzing3 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.

52Samsung LABGEO PA20 AnalyzingViewing QC results1 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.

53Samsung LABGEO PA20 Analyzing3 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.

54Samsung LABGEO PA20 AnalyzingSearching results1 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.

55Samsung LABGEO PA20 Analyzing3 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.

56Samsung LABGEO PA20 AnalyzingPrinting resultsPrinting 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 results1 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.

57Samsung LABGEO PA20 Analyzing3 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.

58Samsung LABGEO PA20 Analyzing5 Once the data is transferred, the printer prints the results.Printing analysis results by analytes Specic analytes of analysis results can be selectively printed.1 On the Results screen, press Patient Results to enter the simple view screen.

59Samsung LABGEO PA20 Analyzing2 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.

60Samsung LABGEO PA20 Analyzing4 A print conrmation 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. ŶThe analysis results view is displayed again after printing.

61Samsung LABGEO PA20 AnalyzingTransferring resultsResults 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.

62Samsung LABGEO PA20 Analyzing2 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 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.

63Samsung LABGEO PA20 AnalyzingDeleting results1 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.

64Samsung LABGEO PA20 Analyzing3 Press Cancel to cancel deleting. Deleted results cannot be restored before you press the Cancel button.

65Samsung LABGEO PA20 Analyzing ŶQuality controlThe 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 control1 Press the QC button on the home screen.

66Samsung LABGEO PA20 Analyzing2 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.

67Samsung LABGEO PA20 Analyzing4 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.

68Samsung LABGEO PA20 Analyzing6 Press the Disc Out button and remove the disc.

69Samsung LABGEO PA20 Analyzing ŶAnalyzer 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.

70Samsung LABGEO PA20 AnalyzingDisplay Calibration, LCD brightness, screensaver, and LCD o 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.Self-Test A self-test of the analyzer can be performed to check whether it is operating normally.3 Administrator settings: Administrator settings require an admin login for security.Lock Functions of analyzer can be locked and a new password can be set.Network Settings for network connection, server settings for EMR/LIS connection can be set.Date&Time The analyzer’s date, time, and display settings can be adjusted.System Device information checking, updates, initialization and results backups can be performed.

71Samsung LABGEO PA20 Analyzing ŶDisplay settingsDisplay settings consist of calibration, LCD brightness, screensaver, and LCD o 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.

72Samsung LABGEO PA20 AnalyzingCalibration (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.

73Samsung LABGEO PA20 AnalyzingLCD Brightness The brightness of the LCD can be adjusted. The brightness can be adjusted in 5 levels.1 Press or for the LCD brightness.2 Press the OK button to set the brightness.You can cancel any changes by pressing the Back button without pressing the OK button.

74Samsung LABGEO PA20 AnalyzingScreensaver settingsA screensaver is automatically activated after a set period of time to protect the analyzer’s LCD screen. The screensaver can be turned on or o, 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 o.2 The screensaver (a clock) is activated after the set amount of time has passed without use.

75Samsung LABGEO PA20 AnalyzingLCD O settings The LCD O function protects the analyzer’s LCD screen and saves power by turning the LCD o after a set period of time.1 Press or to select when the LCD is to be turned O.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 o automatically after the set amount of time has passed without use.

76Samsung LABGEO PA20 Analyzing ŶVolume settings 1 Press the Settings button on the home screen.2 Press the Volume button.3 Set each volume by pressing or .4 Press the OK button to set the volume. Press the Back button to cancel.

77Samsung LABGEO PA20 Analyzing ŶAnalysis 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.

78Samsung LABGEO PA20 AnalyzingUnit settingsThe 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.

79Samsung LABGEO PA20 AnalyzingConversion between SI and non-SI Units (Non-SI X Factor = SI) NO Abbr. Full Name Conventional UnitConversion Factor SI Unit1 ALT Alanine Aminotransferase U/L 1 U/L2 AST Aspartate Aminotransferase U/L 1 U/L3 CK Creatine kinase U/L 1 U/L4 LD Lactate dehydrogenase U/L 1 U/L5 BUN Blood Urea Nitrogen mg/dL 0.357 mmol/L6 K Potassium mEq/L 1 mmol/L7 TCO2 Total CO2 mEq/L 1 mmol/L8 AMY Amylase U/L 1 U/L9 GGT r-Glutamyltransferase U/L 1 U/L10 ALP Alkaline Phosphatase U/L 1 U/L11 Na Sodium mEq/L 1 mmol/L12 Cl Chloride mEq/L 1 mmol/L13 CHOL Total Cholesterol mg/dL 0.0259 mmol/L14 GLU Glucose mg/dL 0.0555 mmol/L15 TRIG Triglyceride mg/dL 0.0113 mmol/L16 TBIL Total Bilirubin mg/dL 17.1 mol/L17 TP Total Protein g/dL 10 g/L18 DBIL Direct Bilirubin mg/dL 17.1 mol/L19 CREA Creatinine mg/dL 88.4 mol/L20 Ca Calcium mg/dL 0.25 mmol/L21 ALB Albumin g/dL 10 g/L22 HDL High-density lipoprotein cholesterol mg/dL 0.0259 mmol/L23 UA Uric Acid mg/dL 59.48 mol/L24 LDL Low-density lipoprotein cholesterol mg/dL 0.0259 mmol/L25 HbA1c HbA1c % ((%) - 2.15) x 10.929 mmol/mol26 TnI Troponin I ng/ml 1 ug/L27 CK_MB Creatine Kinase-MB ng/ml 1 ug/L28 Myo Myoglobin ng/ml 1 ug/L29 NT-BMPN-terminal pro-Brain Natriuretic Peptide ng/ml 1 ug/L

80Samsung LABGEO PA20 AnalyzingChange orderThe order of analytes displayed when viewing analysis results can be adjusted.The changes aect 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.

81Samsung LABGEO PA20 Analyzing3 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.

82Samsung LABGEO PA20 AnalyzingReference range settings The reference range of analytes can be adjusted.1 Press the Reference Range button.

83Samsung LABGEO PA20 Analyzing2 Press the entry eld of the analyte and a number pad appears on the screen.Enter a value for the analyte and press the OK button.

84Samsung LABGEO PA20 Analyzing ŶQC materialQC materials can be set.Registering QC Material1 Press the QC Material button.2 Press the Add button in the lower-right corner.

85Samsung LABGEO PA20 Analyzing3 To display the keypad, tap an empty eld. ŶKeyboard IME

86Samsung LABGEO PA20 Analyzing ŶNumeric Keypad 4 Select the analyte to add and press OK.

87Samsung LABGEO PA20 Analyzing5 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.

88Samsung LABGEO PA20 Analyzing7 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 Press the OK button after inputting the values.Press the OK button in the pop-up conrmation window, and QC materialregistration is completed.

89Samsung LABGEO PA20 AnalyzingChanging QC material 1 Press the QC Material button.2 Select the Material to change.

90Samsung LABGEO PA20 Analyzing3 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 conrmation window to save your QC material changes.

91Samsung LABGEO PA20 AnalyzingDeleting QC material 1 Press the QC Material button.2 Select a Material to delete.

92Samsung LABGEO PA20 Analyzing3 Press the OK button in the pop-up conrmation window to delete the QC material.

93Samsung LABGEO PA20 Analyzing ŶPrint settingsSet 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.

94Samsung LABGEO PA20 Analyzing3 Press Print and set the Print Result.ManualThe 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.AutomaticAnalysis results are printed automatically when the analysis completes and the printer is connected. Results can also be printed manually from the Results screen and the analysis result viewing screen in the order list.

95Samsung LABGEO PA20 Analyzing ŶBarcode 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.

96Samsung LABGEO PA20 Analyzing3 Select the Barcode tab.4 Set the barcode format (Start Point, ID Length).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.

97Samsung LABGEO PA20 Analyzing ŶLanguage settings Select the language to be used by the analyzer.1 Press the Setting button on the home screen.2 Select the Language button.

98Samsung LABGEO PA20 Analyzing3 Select a language from English, Spanish, or Korean, and press the OK button. Press the Back button to cancel.

99Samsung LABGEO PA20 Analyzing ŶSelf-test Tests the hardware status of the analyzer.1 Press the Setting button on the home screen.2 Press the Self-Test button.

100Samsung LABGEO PA20 AnalyzingWhen 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.

101Samsung LABGEO PA20 Analyzing4 The Self-test runs.5 A pop-up window prompts you to Remove the Disc when the self-test is completed.

102Samsung LABGEO PA20 Analyzing6 Check the self-test results. Press the Back button to go back to the previous screen.

103Samsung LABGEO PA20 Analyzing ŶAnalyzer 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.

104Samsung LABGEO PA20 Analyzing3 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.

105Samsung LABGEO PA20 Analyzing ŶLock settings Analyzer functions can be locked and new password can be set.Setting security levels for each function1 Press the Setting button on the home screen.Lock settings only appear in Admin Login mode.2 Press the Security&Lockout button.

106Samsung LABGEO PA20 Analyzing3 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.

107Samsung LABGEO PA20 AnalyzingLocking 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.

108Samsung LABGEO PA20 Analyzing3 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.

109Samsung LABGEO PA20 AnalyzingChanging password 1 Press the Setting button on the home screen.Password settings only appear in Admin Login mode.2 Press the Security&Lockout button.

110Samsung LABGEO PA20 Analyzing3 To change the password, press the Change Password button.4 Enter a password and press the OK button.

111Samsung LABGEO PA20 Analyzing5 Enter a new password in the Password and the Conrm password elds and press the OK button.

112Samsung LABGEO PA20 Analyzing ŶNetwork settingsNetwork 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 network1 Press the Setting button on the home screen.Network settings only appear in Admin Login mode.2 Press the Network button.

113Samsung LABGEO PA20 Analyzing3 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 ( ): The signal strength of wireless AP.4 Attempts to connect to the network. If the connection is successful, the button is changed .

114Samsung LABGEO PA20 AnalyzingSetting network connections 1 Select the network. 2 Select Auto or Manual.

115Samsung LABGEO PA20 Analyzing3 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 MaskSubnet 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. When entering an IP address manually, not entering a correct subnet mask may result in connection failures.GatewayGateway can only be changed if the IP address is entered manually. Enter a gateway according to your network settings. Entering a gateway address is optional.DNS ServerDNS server can only be changed if the IP address is entered manually. Enter a DNS server address according to your network settings. Entering a DNS server address is optional.4 Press the OK button to save your network settings, then go back to the previous screen.If you set the IP address to Automatic, the address may be set incorrectly and may not work with EMR or the LABGEO Data Manager. Set the IP address to Manual to avoid this problem.Disconnecting to a networkTo disconnect the connected network, press button.

116Samsung LABGEO PA20 AnalyzingSetting EMR/LIS1 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.

117Samsung LABGEO PA20 Analyzing ŶLock settingsSelect 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.

118Samsung LABGEO PA20 Analyzing3 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.

119Samsung LABGEO PA20 Analyzing ŶChanging 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.

120Samsung LABGEO PA20 Analyzing3 Select the Format tab. 4 Select display format by pressing or , then press the OK button. Press the Back button to cancel changesDisplay format options are as follows. Display formatting does not apply when setting the date.Date Date SeparatorYYYY-MM-DD e.g.) 2012/10/31MM-DD-YYYY e.g.) 2012/10/31DD-MM-YYYY e.g.) 2012/10/31/ e.g.) 2012/10/31- e.g.) 2012-10-31, e.g.) 2012, 10, 31Time Time Separator12 hour, 24 hour: e.g.) 12:30 PM. e.g.) 12.30 PM, e.g.) 12,30 PM

121Samsung LABGEO PA20 Analyzing ŶSystem 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.

122Samsung LABGEO PA20 Analyzing3 Check the current system information.

123Samsung LABGEO PA20 AnalyzingSystem 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.

124Samsung LABGEO PA20 Analyzing3 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 Conrm the initialization. Press the No button to cancel the initialization.

125Samsung LABGEO PA20 Analyzing5 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.

127Samsung LABGEO PA20 AnalyzingUSB 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 Conrm backup.You can check the Delete the internal memory after backup is complete.

128Samsung LABGEO PA20 Analyzing3 Press the Cancel button to cancel the USB backup.4 When a pop-up window noties you that the backup has completed, press the OK button, then remove the USB memory device.

129Samsung LABGEO PA20 AnalyzingSystem 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.t USB memory: A USB memory device can be used to update the system by copying the update les to the USB memory device and plugging it into the USB port on the rear of the analyzer.

130Samsung LABGEO PA20 Analyzing3 The analyzer reboots when the update completes.The system does not reboot when only the disc information(XML) has been updated.

131Samsung LABGEO PA20 Analyzing ŶTurning o power1 Press the power button on the right-hand side of the analyzer.2 Press the OK button in the system shutdown conrmation pop-up window.

Using the LABGEO Data Manager5Introduction to the LABGEO Data Manager .................................134Installation of the LABGEO Data Manager ...................................135Running the LABGEO Data Manager .............................................139Home screen .......................................................................................140Registering a blood analyzer device .......................................................................141Viewing analysis results ...................................................................147Editing analysis results .....................................................................148Selecting and editing multiple analysis results ...................................................150Printing analysis results ...................................................................151Removing the LABGEO Data Manager ..........................................153

134 Using the LABGEO Data Manager ŶIntroduction to the LABGEO Data ManagerThe 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. ŶAnalysis results managementt Transfer analysis results: Receive analysis results transferred from the blood analyzert Display analysis results: Displays analysis results on the PC screent Sort analysis results: Sorts analysis results by analytes chosen by the usert Search analysis results: Searches analysis results that meet search criteriat Print analysis results: Prints analysis resultst Decide which analytes from analysis results to print: Allows users to print only selected analytes from analysis resultst Edit analysis results: Allows users to add and edit patient information to analysis resultst Import analysis results: Allows users to import and add analysis results from a USB memory device ŶBlood analyzer and the LABGEO Data Manage updatest Analyzer software update: Downloads the latest software and updates the analyzer softwaret LABGEO Data Manager update: Updates the LABGEO Data Manager ŶOther functionst Account management: Create and delete accounts, change passwordst Language selection: Change the language you uset Login/Logout: Login and logout for individual user-controlled accesst Auto-print: Automatically prints data received from the analyzer depending on user preferences

135Samsung LABGEO PA20 Using the LABGEO Data Manager ŶInstallation of the LABGEO Data Manager1 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.

136Samsung LABGEO PA20 Using the LABGEO Data Manager3 Click the Next button.4 Check “I agree to end-user license agreement” and click Next.

137Samsung LABGEO PA20 Using the LABGEO Data Manager5 Click Install to start installing the LABGEO Data Manager.6 Installation begins.

138Samsung LABGEO PA20 Using the LABGEO Data ManagerWhen 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 nished.

139Samsung LABGEO PA20 Using the LABGEO Data Manager ŶRunning the LABGEO Data Manager1 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.

140Samsung LABGEO PA20 Using the LABGEO Data Manager ŶHome screenThis is the home screen of the LABGEO Data Manager.bcefdaa. Menu barb. 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 listd. Search results menue. Shortcut buttons f. View next result

141Samsung LABGEO PA20 Using the LABGEO Data ManagerRegistering a blood analyzer device1 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 networkInput IP address (LAN) Choose when connecting to the analyzer by manually entering the IP address.

142Samsung LABGEO PA20 Using the LABGEO Data ManagerUSB connection settingst 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). Then, reboot the PC and try again.

143Samsung LABGEO PA20 Using the LABGEO Data Manager2 Click the Next button and a list of available blood analyzers is displayed. Select the blood analyzer to connect with and click Next.<USB Connection><LAN Connection>

144Samsung LABGEO PA20 Using the LABGEO Data ManagerIf the analyzer does not appear on the list, check the connection between the analyzer and the PC. If the rewall 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 <Network (LAN)>.<Enter IP address (LAN)>

145Samsung LABGEO PA20 Using the LABGEO Data Manager4 Select the password for the blood analyzer you wish to connect to, designate a letter for identication, and click “Register”.<USB Connection><LAN Connection>

146Samsung LABGEO PA20 Using the LABGEO Data Manager5 When registration is completed, a list of registered analyzers is displayed, as shown in the gure below. You can use the “Add”, “Delete” and “Refresh” buttons to add, delete or update the connection status of blood analyzers.<USB Connection><LAN Connection>

147Samsung LABGEO PA20 Using the LABGEO Data Manager ŶViewing analysis resultsYou 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.

148Samsung LABGEO PA20 Using the LABGEO Data Manager ŶEditing analysis results1 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.

149Samsung LABGEO PA20 Using the LABGEO Data Manager2 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 upper-right corner of the screen to edit the list like a spreadsheet. When editing patient information, chart number and patient name are required information.

150Samsung LABGEO PA20 Using the LABGEO Data ManagerSelecting and editing multiple analysis results1 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.

151Samsung LABGEO PA20 Using the LABGEO Data Manager ŶPrinting analysis resultsEntering hospital information and insurance codes1 Hospital information and insurance codes can be added and modied under the Tools>Customization menu.<Hospital information editing screen><Insurance code editing screen>

152Samsung LABGEO PA20 Using the LABGEO Data Manager2 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.

153Samsung LABGEO PA20 Using the LABGEO Data Manager ŶRemoving the LABGEO Data Manager1 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.

154Samsung LABGEO PA20 Using the LABGEO Data Manager3 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.

6MaintenanceMaintenance .......................................................................................156Maintenance ....................................................................................................................156Cleaning the exterior ....................................................................................................156Cleaning the Disc Tray ..................................................................................................157Transportation and Storage .......................................................................................157

156 Maintenance ŶMaintenanceNo maintenance of the Samsung LABGEOPA20 is required other than cleaning the exterior and disc tray.Maintenance ŶCheck the analyzer on a regular basis even when it works properly. If you nd a problem with the analyzer, stop operating it and contact Samsung Technical Support. ŶClean the analyzer on a regular basis.Cleaning the exteriorCleaning the exterior of the Samsung LABGEOPA20 should be performed whenever necessary. Most spills and stains can be removed with water or mild detergent. ŶSwitch the Analyzer o and unplug the power supply when the shutdown procedure is completed. ŶClean the outside of the Analyzer and the touch display with a clean, lint-free and non-abrasive cloth dampened in water or a mild detergent.t To disinfect the exterior of the instrument, rst remove as much of the spilled material as possible with a cloth dampened in disinfectant (e.g., 30% isopropyl alcohol). The surface of the Analyzer should be exposed to the disinfectant for at least 10 minutes before wiping o with a fresh damp cloth. ŶAllow the Analyzer to air dry. ŶPlug in the power supply and switch on the Analyzer.Do not use any cleaning liquid or equipment other than those recommended above. Do not immerse the Analyzer in water or other liquids. The Analyzer must be switched o and unplugged before cleaning.

157Samsung LABGEO PA20 MaintenanceCleaning the Disc Tray ŶTo clean or disinfect the disc tray, tap “Run” on the home screen to open the tray and follow the instructions above.Transportation and Storage ŶDo not move the analyzer while the disc is being analyzed. Please be careful with physical impact or vibration when transportation when moving the analyzer. ŶThe main body should be cleaned up. Store and keep in a steady place avoiding the moisture, dust, chemicals, ammable gases and direct sunshine when you do not use this device for a long term.

7TroubleshootingTroubleshooting ................................................................................160Check before requesting repair ................................................................................160Restoring factory settings ...........................................................................................160Error List ..............................................................................................161

160 Troubleshooting ŶTroubleshootingCheck before requesting repair ŶThe 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  rst. ŶIf the power still doesn’t turn on, contact Samsung Electronics Technical Support.Restoring factory settings ŶThe analyzer’s factory setting can be restored when it functions abnormally or when settings need to be restored to factory settings. Please refer to System Reset under Settings. You can delete only the stored data or all data and all settings.Select Settings > System > Initialization > Delete all results and settings.

161Samsung LABGEO PA20 ŶError ListError Code Message Problem Solution202001B Setting Error Unable to save settings after making changes.Contact Technical Support.203001C Lack of Storage Space ErrorInsucient 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 ErrorUSB memory device is not compatible or shows a le error in the drive.Try again or use a compatible204012B Update Server Connect ErrorConnection to update server is unstable.Contact Technical Support.205001C Data Transfer Error Analyzer’s LAN connection is unstable.Make sure that the LAN cable is plugged in securely. If the problem persists, contact Technical Support.205003C Data Transfer ErrorConnection between the analyzer and PC is unstable.Make sure that the LAN cable connection between the analyzer and PC are secure.205004C Data Transfer ErrorThere are no analysis results to transfer to the PC.Make sure that there are analysis results to backup in the analyzer. 205006C Data Transfer ErrorThere is insucient storage space on the PC to receive analysis results from the analyzer.Check the available space on the PC (HDD and external storage) and make more space available.205007C Printer Connect ErrorConnected to the internal printer is unstable.Contact Technical Support.205101B Data Transfer Error Response from the PC has timed out.Check your network connections.205201B Data Transfer Error Response from EMR has timed out.Check your network connections.

162Samsung LABGEO PA20 Error Code Message Problem Solution205102B 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.Replace the disc with a disc for analysis.206003A Barcode Error The disc has expired.Replace the disc with one with a valid expiration date and run the analysis again.206004ABarcode ErrorAnalyzer is unusable due to disc barcode error.Contact Technical Support.206005A206007A Barcode ErrorUsing disc with new analytes requires a software update.Contact Technical Support.206008A - 206010A Barcode ErrorUnable to use the device due to disc barcode error.Contact Technical Support.206020A Barcode ErrorUnable to use the device due to disc barcode error.Contact Technical Support.206100A- 206103A RFID ErrorUnable to use the device due to RFID error.Contact Technical Support.207002A Analysis Info Error Analyzer requires new analysis information.Contact Technical Support.207042C Used Disc The disc has been used before.Try again after replacing the contaminated disc with a new one.208202B Insucient SampleThe amount of the injected blood sample is insucient.Make sure that a sucient amount of blood has been injected.

163Samsung LABGEO PA20 Error Code Message Problem Solution209001C Out of USB storage spaceInsucient space on the external USB memory device connected for backing up data from the analyzer.Delete the les on the USB memory device or use a new USB memory device.209002C USB is LockedThe external USB memory device connected to the analyzer is write-protected.Make sure that the write-protection on the USB memory device is unlocked. 209003C Not Connected USB The connection to the externalMake sure that a sucient amount of blood has been injected.305010A Temperature IC Error Unable to use the internal temperature IC.Contact Technical Support.305011A Temperature ErrorUnable to temperature monitoring when analyzing.Contact Technical Support.If the display shows other error code besides listed codes or if you have a question regarding the error codes, contact Samsung Technical Support at XXX-XXX-XXXX.

Other Information8Quaility control policy ......................................................................166Westgard multi-rule technique .................................................................................166System information ...........................................................................167Other information .............................................................................168Product Service ..................................................................................169Index ....................................................................................................170

166 Other information ŶQuaility control policyWestgard multi-rule technique ŶLevey-Jenning Approach1:2S 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.R:4S Rejection rule (random error): 1 control is outside 2SD in one direction 1 control is outside 2SD in the other direction (separating them by 4SD).4:1S Rejection rule (systematic error): 4 consecutive controls exceed the same mean plus or minus 1SD.10:mean Rejection rule (systematic error): 10 consecutive controls fall on one side of the mean (shift).

167Samsung LABGEO PA20 ŶSystem informationCategory Item Specications NotesProcessor/OS ARM CortexTM-A8 1GHz CPU/Embedded LinuxSystem Memory NAND 512MB x 8bit x 1ea (2Gbit)SDRAM 64MB x 16bit x 4ea (2Gbit)I/O Display 7 inch wide, 800 x 480, TFT LCDTouch 7 inch 4-wire panelLED Power StatusKey Power, StopPrinter Built-in Thermal Printer (2 inch)Thermal Paper (recommended)HANSOL PAPER 65GSM Paper width (58mm, 2.36’’) Paper roll size : max. 40mm (1.57’’)Barcode USB Barcode Reader (Option)Interface Ethernet 10/100 Base-TWireless Lan 802g.11a/b/g/n. Dual bandUSB Host USB 2.0 3 port (Front 1ea, Rear 2ea)USB Client USB 2.0 1 portPower SMPS Input : 120W, 100-240V~, 50-60Hz Output : DC +24V, +15V, -15V, +5V, +3.3VLight Source LEDs 340nm - 700nmLaser Laser Diode Class IV, 808 nm, Power < 1.5W, Fiber-Coupled Output (NA=0.22)Size 246mm(W) x 375mm(D) x 289mm(H) Weight 9.2KgTemperature Operating : 10 - 32˚C Storage & Shipping : -10 - 40 ˚C

168Samsung LABGEO PA20 Category Item Specications NotesType of Installation For Indoor use onlyHumidity Operating : 0% to 80% Storage & Shipping : 0% to 80%AltitudeOperating : 3,048m Storage & Shipping : 10,668m ŶOther informationMedical Device Name Clinical Chemistry and Immunology AnalyzerModel Name Samsung LABGEO PA20Manufacturer and AddressSamsung Electronics Co., Ltd., 129 Samsung-ro, Yeongtong-gu, Suwon-si,Gyeonggi-doOperating System 2.6.32.9Maximum Analysis Capability Normal : 5,000Quality Control : 3,000PC S/W Operation EnvironmentOS Windows XP, Windows 2000, Windows Vista, Windows 7H/WPentium 4 or higherMore than 100 MB of available HDD space

169Samsung LABGEO PA20 ŶProduct ServiceSamsung Electronics Co., Ltd.129 Samsung-ro, Yeongtong-gu, Suwon-si, Gyeonggi-doPlease contact your retailer for service inquiries.License NoticationThe complete text of the license can be seen in the License.pdf le under the PA20 folder in the installation CD.

170Samsung LABGEO PA20 BBackup 127Beginning analysis 36CCalibration 72Canceling analysis 43Cautions before analyzing 12 Cautions during use 13 Cautions for system installation 14 Cautions in preparing blood samples 14Change language 97 Changing password 109Check before requesting repair 160 Cleaning 156DDisplay settings 64EError List 161 Executing software 139IID 55, 56, 95Initialization 123 Installation 25Intended use 18Introduction of features 23 LLABGEO Data Manager 133LCD Brightness 73 LCD O settings 75 PPreheating 36Preparing blood for analysis 14 Printing analysis results 56QQuality control 84RRegistering analyzer 141 Restoring factory settings 160 ŶIndex

171Samsung LABGEO PA20 SSafety Warnings and Caution 8Screensaver settings 74 Searching results 54Security 105 Self-test 99Setting auto-mode 114 Setting date and time 117 Setting network 112Setting viewing method 80 Setting volume 76 Storage and maintenance after use 156System information 167System settings 121TTrouble shooting 159Touch calibration 72Transferring analysis results 61 Turning power o 131 Turning power on 36 UUpdate 129User setting screen 103 VViewing results 47WWhat’s in the box 21

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Samsung Electronics Co LABGEOPA20 Immunology Analyser User Manual

Samsung Electronics Co Ltd Immunology Analyser

Users Manual

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