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1 | Users Manual | Users Manual | 3.18 MiB |
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. 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 office, 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. 2 Table of Contents 1. Safety Warnings and Caution ........................7 Users 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 ................................................ 14 Preparing to Test Samples .........................................................................14 Cautions for storage and maintenance after use .......... 15 2. Introduction .................................................17 Intended Use ........................................................................ 18 Introduction ......................................................................... 19 Operating Principle ............................................................. 20 Whats in the box ................................................................. 20 Box contents...................................................................................................20 Sold separately ..............................................................................................21 Introduction of features ..................................................... 22 Front (Right) ...................................................................................................22 Front (Left) ......................................................................................................23 Back ...................................................................................................................24 3. Installation ....................................................25 Installation ............................................................................ 26 Replacing printer paper ..................................................... 27 3 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 .........................................................................................36 Preparing analysis ........................................................................................40 Canceling analysis in progress ................................................................43 Analysis completed ....................................................................................45 Viewing analysis results .............................................................................47 Viewing results ..................................................................... 48 Viewing results of patients analysis ......................................................50 Viewing QC results .......................................................................................52 Searching results ..........................................................................................54 Printing results ..............................................................................................56 Transferring results ......................................................................................61 Deleting results .............................................................................................63 Quality control ..................................................................... 65 Starting quality control ..............................................................................65 Analyzer settings (General User Settings) ...................... 69 Display settings ................................................................... 71 Calibration (touch screen calibration) ..................................................72 LCD Brightness .............................................................................................73 Screensaver settings....................................................................................74 LCD Off settings ...........................................................................................75 Volume settings .................................................................. 76 Analysis settings ................................................................. 77 Unit settings ...................................................................................................78 Change order .................................................................................................80 Reference range settings ..........................................................................82 4 Samsung LABGEO PA20 Table of Contents QC material ........................................................................... 84 Registering QC Material .............................................................................84 Changing QC material ...............................................................................89 Deleting QC material ..................................................................................91 Print settings ........................................................................ 93 Barcode settings ................................................................. 95 Language settings .............................................................. 97 Self-test ................................................................................. 99 Analyzer settings (Administrator Settings) ..................103 Lock settings ......................................................................105 Setting security levels for each function ........................................... 105 Locking quality control .......................................................................... 107 Changing password ................................................................................. 109 Network settings ...............................................................112 Connecting to a network ........................................................................ 112 Setting network connections .............................................................. 114 Setting EMR/LIS .......................................................................................... 116 Lock settings.......................................................................117 Changing Date&time format ..........................................119 System settings .................................................................121 System Reset .............................................................................................. 123 USB Backup ................................................................................................. 127 System updates ......................................................................................... 129 Turning off power ..............................................................131 5. Using the LABGEO Data Manager .............133 Introduction to the LABGEO Data Manager .................134 Installation of the LABGEO Data Manager ...................135 5 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 .............................. 150 Printing analysis results ...................................................151 Removing the LABGEO Data Manager ..........................153 6. Maintenance ...............................................155 Maintenance .......................................................................156 Maintenance ............................................................................................... 156 Cleaning the exterior ............................................................................... 156 Cleaning the Disc Tray ............................................................................. 157 Transportation and Storage................................................................... 157 7. Troubleshooting .........................................159 Troubleshooting ................................................................160 Check before requesting repair ............................................................ 160 Restoring factory settings ...................................................................... 160 Error List ..............................................................................161 8. Other Information ......................................165 Quaility control policy ......................................................166 Westgard multi-rule technique ............................................................ 166 System information ...........................................................167 Other information .............................................................168 Product Service ..................................................................169 Index ....................................................................................170 6 1 Safety Warnings and Caution Users 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 ................................................................ 14 Preparing to Test Samples ............................................................................................. 14 Cautions for storage and maintenance after use .......................... 15 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. Malfunctions and damage caused by any other use than specified in the User Manual is excluded from the manufacturers warranty. If the equipment is used in a manner not specified by the manufacturer, the protection provided by the equipment may be impaired. 8 Samsung LABGEO PA20 Safety Warnings and Caution
Users 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. Temperature limitation/ Allowed Temperature Range Shows temperature limit for storage or transport Fragile/Fragile contents; handle with care Keep dry/Package should avoid wetting This way up Loading Unit/Avoid loading more than the marked number of units In Vitro diagnostic device Serial number Manufacturer USB port Ethernet port 9 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. 1.5 W 10 Samsung LABGEO PA20 Safety Warnings and Caution
Cautions for system installation
Keep the analyzer at least 6 inches (15cm) away from any wall to provide adequate ventilation and prevent overheating. Be careful not to expose the analyzer to sources of vibration such as placing it near a centrifuge.
Do 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. The analyzer must be used at an operating temperature of 10 - 32 C
(50- 89 F). The analyzer might be affected by:
Condensing humidity and water
Heat and extreme temperature variations
Electromagnetic radiation
Movement of the analyzer during sample processing
Only use the cable provided with the analyzer.
To avoid risk of fire or electric shock, do not use a damaged power cable. Always use the correct voltage supply. Incorrect voltage can cause damage to the analyzer or result in fire. Be sure that the electrical outlet is properly grounded.
Do not attempt to disassemble, repair or modify the analyzer as damage could occur. Opening the unit will void the warranty. Contact Samsung Technical Support.
Do not place any objects on the analyzer.
Do not cover the rear ventilation panel. This may damage the internal parts, resulting in a fire or electric shock.
Do not introduce foreign substances into the servicing hole.
Turn 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.
Do not touch the power plug with wet hands. This may result in an electric shock. 11 Samsung LABGEO PA20 Safety Warnings and Caution
Cautions for system move
Dropping the product while moving or carrying may cause damage to the product. Be careful of impact when moving the product at all times.
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.
Cautions before use
When the blood is not used immediately, be sure to store it appropriately to prevent it from contamination. Check for dust or other impurities on a regular basis. Always install the product in a well-ventilated, clean, and dry area. Keep the product away from heat-emitting products (such as heaters). It may cause deformation of the product, fire, or adversely influence analysis results.
12 Samsung LABGEO PA20 Safety Warnings and Caution
Cautions during use
This system is for professional use only. The user must be a physician, clinical laboratory personnel, or healthcare professionals. Avoid external shock or vibration during analysis.
Do not use expired discs.
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. The 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. Powder-free gloves must be worn when operating the product.
Do not move the analyzer during operation.
When 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. Always use designated power cable. Do not unplug the device in the middle of an analysis. If the product produces smoke or strange odors, discontinue use, unplug the power cord from the outlet, and contact your local distributor for service information. If 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.
Do not turn off the power during analysis. Press Cancel to abort a test if needed. Discard the disc and start over with a new disc. Be careful not to damage the barcode on the disc. If the barcode is damaged, the test will not perform accurately.
Do not use the analyzer where liquids or chemicals are used or where gas may be produced.
Do not allow liquid to spill into the analyzer. If there is any spillage, disconnect power immediately and contact your local distributor. If you wish to stop the analysis in progress without turning the analyzer off , 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. The operating temperature of the analyzer is 10 - 32 C (50 - 89 F); the analyzer automatically maintains an internal temperature of 37C. (The device shuts off automatically if it exceeds normal operating temperature.)
13 Samsung LABGEO PA20 Safety Warnings and Caution
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. Refer to the Test Instructions for Use for the correct sample volume to be injected into the disc. 14 Samsung LABGEO PA20 Safety Warnings and Caution
Cautions for storage and maintenance after use
Do not store the product in humid areas or areas influenced by temperature, humidity or wind. Store the device on a flat surface and keep it away from vibration or impact.
Do not store the product with chemicals or gas.
Operating conditions and temperature: 10 - 32 C (50 - 89 F),
Humidity: 0% - 80%
Storage conditions and temperature: -10C - +40C , Humidity: 0% - 80%
If 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.
When moving or transporting the product, follow the conditions for using and storing the product specified in this manual. Follow all cautions when moving the product.
A 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.
Used discs must be processed using Medical Waste Treatment Laws after use. 15 Samsung LABGEO PA20 2 Introduction Intended Use ........................................................................................ 18 Introduction ......................................................................................... 19 Operating Principle ............................................................................. 20 Whats in the box ................................................................................. 20 Box contents ...................................................................................................................... 20 Sold separately .................................................................................................................. 21 Introduction of features ..................................................................... 22 Front (Right) ....................................................................................................................... 22 Front (Left) .......................................................................................................................... 23 Back ....................................................................................................................................... 24 Introduction
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. 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. 18 Samsung LABGEO PA20 Introduction
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. 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 different kinds of reagents and buffers. 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 identifies 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. 19 Samsung LABGEO PA20 Introduction
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. For endpoint reactions, the final 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 final absorbance. The fluorometer utilizes a time-resolved fluorescence 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 fluorescence intensity is converted into the concentration of the anlayte.
Whats in the box Box contents Analyzer Samsung LABGEO PA20 BCA-PA20 Power Cable A 1.8m long cable used to supply power to the system. The effective voltage range is between 100-240 VAC
(50-60Hz). Printer paper USB Cable 20 Samsung LABGEO PA20 Introduction User Manual Software installation CD Sold separately Pipette tips Disc Control Serum Barcode scanner (optional)
Please check the above contents of the box after purchase.
If any of the contents are missing or damaged. Do not use the product and contact your retailer for a replacement. 21 Samsung LABGEO PA20 Introduction
Introduction of features Front (Right) 1 2 3 4 5 6 7 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. HOT SURFACE label 22 Front (Left) 1 2 1. Class 1 laser product label 2. Monitor tilting button Samsung LABGEO PA20 Introduction 23 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 3. USB Port for connecting to a computer
: Used to update the software and to back up. The smaller port is provided
: Used to connect to LAN or the Internet 4. Ethernet Port 5. Cooling Fan 6. Biological Hazard Warning 7. Displays basic information of the analyzer including product name, manufacturer, manufactured date and serial number 8. Motor Cover: To be removed for maintenance and only by authorized Samsung Technical Support personnel 9. Speaker 24 3 Installation Installation ............................................................................................ 26 Replacing printer paper ..................................................................... 27 Disc ......................................................................................................... 29 Handling and Storage of the Disc .................................................... 30 Adding the sample to the Disc .......................................................... 31 Installation
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. 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. 26 Samsung LABGEO PA20 Installation
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. 27 Samsung LABGEO PA20 Installation 5 Close the lid and confirm that the paper is positioned between the lid and the front of the printer. 28 Samsung LABGEO PA20 Installation
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. 29 Samsung LABGEO PA20 Installation
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.
Always use powder-free gloves when handling the product.
Store the disc LEVEL between 2 - 8 C (36 - 46 F).
Use by the expiry date marked on the disc pouch or the package label. The analyzer detects and rejects a disc that has expired.
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.
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.
Do not expose the open disc to direct sunlight.
Do not expose the disc to temperatures over 32 C (89 F).
Do not use a disc if the pouch is cut or torn as the reagents inside may be damaged by moisture.
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.
Be careful not to leave fingerprints or other contaminants in the detection areas of the disc.
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 GuidelineSecond Edition (GPS-A2) issued by the Clinical and Laboratory Standards Institute (previously known as NCCLS). This can be found at http://clsi.org. 30 Samsung LABGEO PA20 Installation
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.
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. Do not use a disc that has been dropped. Inspect every disc for damage before use. Never use a damaged disc.
Use a pipette to inject 450 L into the sample injection hole. The disc requires a minimum of 450 L, maximum of 750 L. 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. 31 Samsung LABGEO PA20 Installation
SAMPLE INJECTION
Correct injection volume
Insufficient sample volume Analyzer will show message that insufficient sample has been injected. Carefully pipette an additional 100 L ~ 250 L into the sample injection hole. Tap Retry on analyzer. 32 Samsung LABGEO PA20 Installation
Excessive sample injection During analysis, any surplus sample will move into the overflow chamber as shown below:
(surplus sample overflow sample chamber) Injecting more than 750 L may cause sample chamber to overflow.
Do not use expired discs.
Be careful to insert the disc into the analyzer properly. When inserting the disc the blood sample hole should be facing up. 33 Samsung LABGEO PA20 4 QC material ................................. 84 Registering QC Material ...................... 84 Changing QC material ........................ 89 Deleting QC material .......................... 91 Print settings .............................. 93 Barcode settings ....................... 95 Language settings .................... 97 Self-test ....................................... 99 Analyzer settings
(Administrator Settings) .........103 Lock settings ............................105 Setting security levels for each function ..................................................105 Locking quality control ....................107 Changing password ..........................109 Network settings .....................112 Connecting to a network .................112 Setting network connections ........114 Setting EMR/LIS ...................................116 Lock settings.............................117 Changing Date&time format .......................................119 System settings .......................121 System Reset .......................................123 USB Backup ..........................................127 System updates ..................................129 Turning off power ....................131 Analyzing Analyzing .................................... 36 Turning power on ................................. 36 Preparing analysis ................................. 40 Canceling analysis in progress ........ 43 Analysis completed ............................. 45 Viewing analysis results ...................... 47 Viewing results ........................... 48 Viewing results of patients analysis ..................................................... 50 Viewing QC results ............................... 52 Searching results ................................... 54 Printing results ....................................... 56 Transferring results ............................... 61 Deleting results ..................................... 63 Quality control ........................... 65 Starting quality control ....................... 65 Analyzer settings
(General User Settings) ............. 69 Display settings ......................... 71 Calibration
(touch screen calibration) .................. 72 LCD Brightness ...................................... 73 Screensaver settings ............................ 74 LCD Off settings .................................... 75 Volume settings ........................ 76 Analysis settings ....................... 77 Unit settings ........................................... 78 Change order ......................................... 80 Reference range settings .................. 82 Analyzing
Analyzing Turning power on 1 Before beginning analysis, turn the devices power on. Turn the analyzers 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 2~5minutes to preheat. If the power doesnt turn on, refer to page 159 7. Troubleshooting. 36 2 Once the analyzer is turned on, it performs a hardware check, and the home screen, shown below, is displayed. Samsung LABGEO PA20 Analyzing 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. 37 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. 38 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. 39 Samsung LABGEO PA20 Analyzing Preparing analysis 1 Press the Run button.
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.
To display the keypad, tap on an empty field.
You may enter the Patient ID by scanning a barcode with the barcode scanner. 40 3 Insert a disc loaded with a sample into the tray when it opens, and press the Run button. Samsung LABGEO PA20 Analyzing The disc tray closes automatically if the Run button is not tapped within 30seconds after inserting the disc. 41 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. 42 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. 43 Samsung LABGEO PA20 Analyzing 2 Press the Yes button to cancel, and the No button to resume the analysis.
When an analysis in progress is canceled, the disc cannot be used again. 44 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.
Analytes and analysis results are displayed.
If auto-print is turned on, the device automatically prints the analysis results upon completion.
For instructions on adjusting auto-print settings, please refer to SettingsPeripherals (page 93).
If the device is connected to a PC, the analysis results are automatically transmitted to the PC application(LABGEO DATA MANAGER) upon completion.
For more details on the PC software (LABGEO Data Manager), please refer to page 133. If the EMR/LIS settings are correctly set, the analysis results are automatically transmitted to the EMR/LIS server program.
Please refer to page 116 for instructions on setting the EMR/LIS. Glossary HEM (Hemolysis) Specimens level of hematolysis LIP (Lipemia) Specimens level of lipemia ICT (Icterus) Specimens level of icterus 45 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 analyzers detection range When QC fails Tip The audio notification 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. 46 Samsung LABGEO PA20 Analyzing Viewing analysis results 1 Once the analysis is completed, the results are displayed on the LCD.
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.
Press the Up/Down button to select an analyte from the list. 47 Samsung LABGEO PA20 Analyzing
Viewing results Press the Result button on the home screen to display the Results. Results are grouped by All, Patient and Material QC.
All
Patient 48
Quality Control Samsung LABGEO PA20 Analyzing 49 Samsung LABGEO PA20 Analyzing Viewing results of patients 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 upper-
right corner. 50 3 When you select the patient ID, you can view the patients date of birth, gender and operator ID. Samsung LABGEO PA20 Analyzing 4 To switch to the previous or next result screen, press the arrow buttons on the left and right side of the screen. 51 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. 52 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. 53 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. 54 3 Enter an ID or date and press the OK button to see matching results. Samsung LABGEO PA20 Analyzing 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. 55 Samsung LABGEO PA20 Analyzing Printing results Printing analysis results, including patient ID in certain languages, requires the analyzers 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. 56 3 Select either print range option: Select all within the page or Select all across the pages. Samsung LABGEO PA20 Analyzing 4 When you press the Print button, a pop-up window is displayed. Press the OK button to begin printing.
Press the Cancel button to cancel printing.
Only results requested with the check box will be printed. 57 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 On the Results screen, press Patient Results to enter the simple view screen. 58 2 In the Show detail screen, results for each analyte can be selectively printed by checking the boxes. Samsung LABGEO PA20 Analyzing 3 Uncheck the Analyte you wish to exclude, and press the Print button. 59 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.
The analysis results view is displayed again after printing. 60 Transferring results Samsung LABGEO PA20 Analyzing 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.
The device must be connected to a PC to transfer results. Please refer to page 133 for instructions on using the PC application.
Please refer to page 116 for instructions on setting the EMR/LIS. 61 Samsung LABGEO PA20 Analyzing 2 Press the Send button and select the transferring method. If you select EMR/LIS, only results requested through EMR will be transferred.
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. 62 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. 63 Samsung LABGEO PA20 Analyzing 3 Press Cancel to cancel deleting. Deleted results cannot be restored before you press the Cancel button. 64 Samsung LABGEO PA20 Analyzing
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. 65 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. 66 4 To cancel analysis, press the Cancel button. Once canceled, the disc cannot be used again. Samsung LABGEO PA20 Analyzing 5 Once QC completes, the result screen shown on the right is displayed.
If the device is connected to the LABGEO Data Manager, the analysis results are transferred automatically. If auto-print is turned on, the analysis results are printed automatically.
To print the results, press the Print button. If the results are outside of QC range, is displayed. 67 Samsung LABGEO PA20 Analyzing 6 Press the Disc Out button and remove the disc. 68 Samsung LABGEO PA20 Analyzing
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. 69 Samsung LABGEO PA20 Analyzing Display Volume Analysis Peripherals Language Self-Test Calibration, LCD brightness, screensaver, and LCD off settings can be adjusted. Master volume, booting/ending sound, touch screen, warning/ error sound, and analysis completion sound can be adjusted. Unit of analytes, printing order, reference range, and QC materials can be adjusted. Auto-print and starting point after barcode scanning can be adjusted. The analyzer language can be adjusted. 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 Network Functions of analyzer can be locked and a new password can be set. Settings for network connection, server settings for EMR/LIS connection can be set. Date&Time The analyzers date, time, and display settings can be adjusted. System Device information checking, updates, initialization and results backups can be performed. 70 Samsung LABGEO PA20 Analyzing
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. 71 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.
The crosshairs (+) turn blue after being selected.
If the touch screen recognition is not calibrated accurately after 2-3 calibrations, please contact Samsung Electronics Technical Support. 72 LCD Brightness Samsung LABGEO PA20 Analyzing The brightness of the LCD can be adjusted. The brightness can be adjusted in 5 levels. 1 Press for the LCD brightness. or 2 Press the OK button to set the brightness. You can cancel any changes by pressing the Back button without pressing the OK button. 73 Samsung LABGEO PA20 Analyzing Screensaver settings A screensaver is automatically activated after a set period of time to protect the analyzers LCD screen. The screensaver can be turned on or off, and the time for activating the screensaver can be adjusted. 1 Press to select when the Screensaver starts. or Never 10 min 20 min 30 min 1 hr. When set to Never, the screensaver is turned off. 2 The screensaver (a clock) is activated after the set amount of time has passed without use. 74 LCD Off settings Samsung LABGEO PA20 Analyzing The LCD Off function protects the analyzers LCD screen and saves power by turning the LCD off after a set period of time. 1 Press to select when the LCD is to be turned Off. or Never 30 min 1 hr 2 hrs 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. 75 Samsung LABGEO PA20 Analyzing
Volume 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. 76 Samsung LABGEO PA20 Analyzing
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. 77 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. 78 Conversion between SI and non-SI Units (Non-SI X Factor = SI) Samsung LABGEO PA20 Analyzing Conventional Conversion NO Abbr. Full Name 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 ALT Alanine Aminotransferase AST CK LD BUN K TCO2 AMY GGT ALP Na Cl CHOL GLU TRIG TBIL TP DBIL CREA Ca ALB HDL UA LDL Aspartate Aminotransferase Creatine kinase Lactate dehydrogenase Blood Urea Nitrogen Potassium Total CO2 Amylase r-Glutamyltransferase Alkaline Phosphatase Sodium Chloride Total Cholesterol Glucose Triglyceride Total Bilirubin Total Protein Direct Bilirubin Creatinine Calcium Albumin High-density lipoprotein cholesterol Uric Acid Low-density lipoprotein cholesterol 25 HbA1c HbA1c TnI 26 27 CK_MB Myo 28 NT-
BMP 29 Troponin I Creatine Kinase-MB Myoglobin N-terminal pro-Brain Natriuretic Peptide Unit U/L U/L U/L U/L mg/dL mEq/L mEq/L U/L U/L U/L mEq/L mEq/L mg/dL mg/dL mg/dL mg/dL g/dL mg/dL mg/dL mg/dL g/dL mg/dL mg/dL mg/dL
%
ng/ml ng/ml ng/ml ng/ml Factor 1 1 1 1 0.357 1 1 1 1 1 1 1 0.0259 0.0555 0.0113 17.1 10 17.1 88.4 0.25 10 0.0259 59.48 0.0259 SI Unit U/L U/L U/L U/L mmol/L mmol/L mmol/L U/L U/L U/L mmol/L mmol/L mmol/L mmol/L mmol/L mol/L g/L mol/L mol/L mmol/L g/L mmol/L mol/L mmol/L
((%) - 2.15) x 10.929 mmol/mol 1 1 1 1 ug/L ug/L ug/L ug/L 79 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. 80 3 Select Disc. Samsung LABGEO PA20 Analyzing 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. 81 Samsung LABGEO PA20 Analyzing Reference range settings The reference range of analytes can be adjusted. 1 Press the Reference Range button. 82 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. 83 Samsung LABGEO PA20 Analyzing
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. 84 3 To display the keypad, tap an empty field. Samsung LABGEO PA20 Analyzing
Keyboard IME 85 Samsung LABGEO PA20 Analyzing
Numeric Keypad 4 Select the analyte to add and press OK. 86 5 To add the selected analyte, press the Add Analyte button. Samsung LABGEO PA20 Analyzing 6 To change the QC rules for the analyte, press the Yes button on the right. 87 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 Chapter8. 8 Press the OK button after inputting the values. Press the OK button in the pop-up confirmation window, and QC material registration is completed. 88 Samsung LABGEO PA20 Analyzing Changing QC material 1 Press the QC Material button. 2 Select the Material to change. 89 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. 90 Samsung LABGEO PA20 Analyzing Deleting QC material 1 Press the QC Material button. 2 Select a Material to delete. 91 Samsung LABGEO PA20 Analyzing 3 Press the OK button in the pop-up confirmation window to delete the QC material. 92 Samsung LABGEO PA20 Analyzing
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. 93 Samsung LABGEO PA20 Analyzing 3 Press Print and set the Print Result. Manual Automatic 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. Analysis 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. 94 Samsung LABGEO PA20 Analyzing
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. 95 Samsung LABGEO PA20 Analyzing 3 Select the Barcode tab. 4 Set the barcode format (Start Point, ID Length). Start Point ID Length Set a valid start point for analysis ID input by the barcode scanner. Set a valid ID length for analysis ID input by the barcode scanner. 96 Samsung LABGEO PA20 Analyzing
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. 97 Samsung LABGEO PA20 Analyzing 3 Select a language from English, Spanish, or Korean, and press the OK button. Press the Back button to cancel. 98 Samsung LABGEO PA20 Analyzing
Self-test Tests the hardware status of the analyzer. 1 Press the Setting button on the home screen. 2 Press the Self-Test button. 99 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. 100 4 The Self-test runs. Samsung LABGEO PA20 Analyzing 5 A pop-up window prompts you to Remove the Disc when the self-test is completed. 101 Samsung LABGEO PA20 Analyzing 6 Check the self-test results. Press the Back button to go back to the previous screen. 102 Samsung LABGEO PA20 Analyzing
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. 103 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. 104 Samsung LABGEO PA20 Analyzing
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. 105 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. 106 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. 107 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. 108 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. 109 Samsung LABGEO PA20 Analyzing 3 To change the password, press the Change Password button. 4 Enter a password and press the OK button. 110 5 Enter a new password in the Password and the Confirm password fields and press the OK button. Samsung LABGEO PA20 Analyzing 111 Samsung LABGEO PA20 Analyzing
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. 112 3 Ethernet and wireless access point list is displayed. To connect the network, press button. Samsung LABGEO PA20 Analyzing
signal (
: The wireless AP needs the password to connect.
): The signal strength of wireless AP. 4 Attempts to connect to the network. If the connection is successful, the button is changed
. 113 Samsung LABGEO PA20 Analyzing Setting network connections 1 Select the network. 2 Select Auto or Manual. 114 Samsung LABGEO PA20 Analyzing 3 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 Gateway DNS Server 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. When entering an IP address manually, not entering a correct subnet mask may result in connection failures. Gateway 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 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 network To disconnect the connected network, press button. 115 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. 116 Samsung LABGEO PA20 Analyzing
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. 117 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. 118 Samsung LABGEO PA20 Analyzing
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. 119 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 e.g.) 2012/10/31 MM-DD-YYYY e.g.) 2012/10/31 DD-MM-YYYY e.g.) 2012/10/31 Time 12 hour, 24 hour 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.) 12,30 PM 120 Samsung LABGEO PA20 Analyzing
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. 121 Samsung LABGEO PA20 Analyzing 3 Check the current system information. 122 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. 123 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. 124 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. 125 Samsung LABGEO PA20 Analyzing 126 Samsung LABGEO PA20 Analyzing USB Backup Saves the analysis results saved in the analyzer to a USB memory device.
QC results cannot be backed up.
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. 127 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. 128 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.
PC, Internet: The analyzer must be connected to a LAN or USB cable.
USB memory: A USB memory device can be used to update the system by copying the update files to the USB memory device and plugging it into the USB port on the rear of the analyzer. 129 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. 130 Samsung LABGEO PA20 Analyzing
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. 131 Samsung LABGEO PA20 5 Using the LABGEO Data Manager 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 ...................................................................147 Editing analysis results .....................................................................148 Selecting and editing multiple analysis results ...................................................150 Printing analysis results ...................................................................151 Removing the LABGEO Data Manager ..........................................153 Using the LABGEO Data Manager
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 analyzers results, download the latest software updates, and print the analysis results. The features of the LABGEO Data Manager are as follows.
Analysis results management
Transfer analysis results: Receive analysis results transferred from the blood analyzer
Display analysis results: Displays analysis results on the PC screen
Sort analysis results: Sorts analysis results by analytes chosen by the user
Search analysis results: Searches analysis results that meet search criteria
Print analysis results: Prints analysis results
Decide which analytes from analysis results to print: Allows users to print only selected analytes from analysis results
Edit analysis results: Allows users to add and edit patient information to analysis results Import analysis results: Allows users to import and add analysis results from a USB memory device
Blood analyzer and the LABGEO Data Manage updates
Analyzer software update: Downloads the latest software and updates the analyzer software
LABGEO Data Manager update: Updates the LABGEO Data Manager
Other functions
Account management: Create and delete accounts, change passwords
Language selection: Change the language you use
Login/Logout: Login and logout for individual user-controlled access
Auto-print: Automatically prints data received from the analyzer depending on user preferences 134 Samsung LABGEO PA20 Using the LABGEO Data Manager
Installation of the LABGEO Data Manager 1 Insert the installation CD into your computers 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. 135 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. 136 Samsung LABGEO PA20 Using the LABGEO Data Manager 5 Click Install to start installing the LABGEO Data Manager. 6 Installation begins. 137 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. 138 Samsung LABGEO PA20 Using the LABGEO Data Manager
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. 139 d f Samsung LABGEO PA20 Using the LABGEO Data Manager
Home screen This is the home screen of the LABGEO Data Manager. a 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. View next result 140 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) Network (LAN) Choose when the blood analyzer is connected to the PC by a USB cable. 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. 141 Samsung LABGEO PA20 Using the LABGEO Data Manager USB connection settings
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. 142 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.
<USB Connection>
<LAN Connection>
143 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 <Network (LAN)>.
<Enter IP address (LAN)>
144 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.
<USB Connection>
<LAN Connection>
145 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.
<USB Connection>
<LAN Connection>
146 Samsung LABGEO PA20 Using the LABGEO Data Manager
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. 147 Samsung LABGEO PA20 Using the LABGEO Data Manager
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. 148 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 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. 149 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. 150 Samsung LABGEO PA20 Using the LABGEO Data Manager
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.
<Hospital information editing screen>
<Insurance code editing screen>
151 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.
By checking Auto-print under File > Print Options, the software automatically prints any new analysis result received from the blood analyzer. 152 Samsung LABGEO PA20 Using the LABGEO Data Manager
Removing the LABGEO Data Manager 1 Caution: You must close the program before uninstalling it. Uninstalling the program also erases all the programs 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. 153 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. 154 6 Maintenance Maintenance .......................................................................................156 Maintenance ....................................................................................................................156 Cleaning the exterior ....................................................................................................156 Cleaning the Disc Tray ..................................................................................................157 Transportation and Storage .......................................................................................157 Maintenance
Maintenance No maintenance of the Samsung LABGEOPA20 is required other than cleaning the exterior and disc tray. Maintenance
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.
Clean the analyzer on a regular basis. Cleaning the exterior Cleaning the exterior of the Samsung LABGEOPA20 should be performed whenever necessary. Most spills and stains can be removed with water or mild detergent.
Switch the Analyzer off and unplug the power supply when the shutdown procedure is completed.
Clean 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.
To disinfect the exterior of the instrument, first 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 off with a fresh damp cloth.
Allow the Analyzer to air dry.
Plug 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 off and unplugged before cleaning. 156 Samsung LABGEO PA20 Maintenance Cleaning the Disc Tray
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
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.
The main body should be cleaned up. Store and keep in a steady place avoiding the moisture, dust, chemicals, flammable gases and direct sunshine when you do not use this device for a long term. 157 Samsung LABGEO PA20 7 Troubleshooting Troubleshooting ................................................................................160 Check before requesting repair ................................................................................160 Restoring factory settings ...........................................................................................160 Error List ..............................................................................................161 Troubleshooting
Troubleshooting Check before requesting repair
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.
If the power still doesnt turn on, contact Samsung Electronics Technical Support. Restoring factory settings
The analyzers 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. 160 Samsung LABGEO PA20
Error List Error Code Message 202001B Setting Error Problem Unable to save settings after making changes. Solution Contact Technical Support. 203001C 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. Try again or use a compatible 204012B Update Server Connect Error Connection to update server is unstable. Contact Technical Support. 205001C Data Transfer Error Analyzers LAN connection is unstable. 205003C Data Transfer Error Connection between the analyzer and PC is unstable. Make sure that the LAN cable is plugged in securely. If the problem persists, contact Technical Support. Make sure that the LAN cable connection between the analyzer and PC are secure. 205004C Data Transfer Error 205006C Data Transfer Error 205007C Printer Connect Error 205101B Data Transfer Error 205201B Data Transfer Error There are no analysis results to transfer to the PC. Make sure that there are analysis results to backup in the analyzer. There is insufficient storage space on the PC to receive analysis results from the analyzer. Connected to the internal printer is unstable. Check the available space on the PC (HDD and external storage) and make more space available. Contact Technical Support. Response from the PC has timed out. Check your network connections. Response from EMR has timed out. Check your network connections. 161 Samsung LABGEO PA20 Error Code Message 205102B Data Transfer Error 205202B Data Transfer Error 206001A Barcode Read Error 206002A Barcode Error Problem Connection to the PC has connection errors. Solution Check your network connections. Connection to the EMR has connection errors. Check your network connections. The barcode on the disc is contaminated. Try again after replacing the contaminated disc with a new one. The disc is not for the blood analyzer. Replace the disc with a disc for analysis. 206003A Barcode Error The disc has expired. 206004A 206005A Barcode Error 206007A Barcode Error 206008A -
206010A Barcode Error 206020A Barcode Error 206100A-
206103A RFID Error Analyzer is unusable due to disc barcode error. Using disc with new analytes requires a software update. Unable to use the device due to disc barcode error. Unable to use the device due to disc barcode error. Unable to use the device due to RFID error. Replace the disc with one with a valid expiration date and run the analysis again. Contact Technical Support. Contact Technical Support. Contact Technical Support. Contact Technical Support. Contact Technical Support. 207002A Analysis Info Error 207042C Used Disc 208202B Insufficient Sample Analyzer requires new analysis information. Contact Technical Support. The disc has been used before. Try again after replacing the contaminated disc with a new one. The amount of the injected blood sample is insufficient. Make sure that a sufficient amount of blood has been injected. 162 Error Code Message 209001C Out of USB storage space 209002C USB is Locked Problem Insufficient space on the external USB memory device connected for backing up data from the analyzer. The external USB memory device connected to the analyzer is write-
protected. 209003C Not Connected USB The connection to the external Samsung LABGEO PA20 Solution Delete the files on the USB memory device or use a new USB memory device. Make sure that the write-protection on the USB memory device is unlocked. Make sure that a sufficient amount of blood has been injected. 305010A Temperature IC Error 305011A Temperature Error Unable to use the internal temperature IC. Contact Technical Support. Unable 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. 163 Samsung LABGEO PA20 8 Other Information Quaility control policy ......................................................................166 Westgard multi-rule technique .................................................................................166 System information ...........................................................................167 Other information .............................................................................168 Product Service ..................................................................................169 Index ....................................................................................................170 Other information
Quaility control policy Westgard multi-rule technique
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. 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). 166 Samsung LABGEO PA20
System information Category Item Specifications Notes Processor/OS System Memory I/O NAND SDRAM Display Touch LED Key Printer Thermal Paper
(recommended) Barcode Ethernet ARM CortexTM-A8 1GHz CPU/Embedded Linux 512MB x 8bit x 1ea (2Gbit) 64MB x 16bit x 4ea (2Gbit) 7 inch wide, 800 x 480, TFT LCD 7 inch 4-wire panel Power Status Power, Stop Built-in Thermal Printer (2 inch) HANSOL PAPER 65GSM Paper width (58mm, 2.36) Paper roll size : max. 40mm (1.57) USB Barcode Reader (Option) 10/100 Base-T Interface Wireless Lan 802g.11a/b/g/n. Dual band USB Host USB Client USB 2.0 3 port (Front 1ea, Rear 2ea) USB 2.0 1 port Power SMPS Input : 120W, 100-240V~, 50-60Hz Output : DC +24V, +15V, -15V, +5V, +3.3V Light Source LEDs 340nm - 700nm Laser Diode Laser Size Weight Temperature Class IV, 808 nm, Power < 1.5W, Fiber-Coupled Output (NA=0.22) 246mm(W) x 375mm(D) x 289mm(H) 9.2Kg Operating : 10 - 32C Storage & Shipping : -10 - 40 C 167 Samsung LABGEO PA20 Category Type of Installation Humidity Altitude Item Specifications Notes For Indoor use only Operating : 0% to 80%
Storage & Shipping : 0% to 80%
Operating : 3,048m Storage & Shipping : 10,668m
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 2.6.32.9 Maximum Analysis Capability Normal : 5,000 Quality Control : 3,000 PC S/W Operation Environment OS H/W Windows XP, Windows 2000, Windows Vista, Windows 7 Pentium 4 or higher More than 100 MB of available HDD space 168 Samsung LABGEO PA20
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. 169 Samsung LABGEO PA20
Index B C D E Backup 127 Beginning analysis 36 Calibration 72 Canceling analysis 43 Cautions before analyzing 12 Cautions during use 13 Cautions for system installation 14 Cautions in preparing blood samples 14 Change language 97 Changing password 109 Check before requesting repair 160 Cleaning 156 Display settings 64 Error List 161 Executing software 139 I L P Q R ID 55, 56, 95 Initialization 123 Installation 25 Intended use 18 Introduction of features 23 LABGEO Data Manager 133 LCD Brightness 73 LCD Off settings 75 Preheating 36 Preparing blood for analysis 14 Printing analysis results 56 Quality control 84 Registering analyzer 141 Restoring factory settings 160 170 S Safety Warnings and Caution 8 Screensaver settings 74 Searching results 54 Security 105 Self-test 99 Setting auto-mode 114 Setting date and time 117 Setting network 112 Setting viewing method 80 Setting volume 76 Storage and maintenance after use 156 System information 167 System settings 121 Samsung LABGEO PA20 Trouble shooting 159 Touch calibration 72 Transferring analysis results 61 Turning power off 131 Turning power on 36 Update 129 User setting screen 103 Viewing results 47 Whats in the box 21 T U V W 171 Federal Communication Commission Interference Statement
FCC Caution:
IMPORTANT NOTE: FCC Radiation Exposure Statement:
HM68-01006C/2012-07
frequency | equipment class | purpose | ||
---|---|---|---|---|
1 | 2012-09-20 | 2412 ~ 2462 | DTS - Digital Transmission System | Original Equipment |
app s | Applicant Information | |||||
---|---|---|---|---|---|---|
1 | Effective |
2012-09-20
|
||||
1 | Applicant's complete, legal business name |
Samsung Electronics Co Ltd
|
||||
1 | FCC Registration Number (FRN) |
0005810205
|
||||
1 | Physical Address |
19 Chapin Rd., Building D
|
||||
1 |
Pine Brook, New Jersey 07058
|
|||||
1 |
United States
|
|||||
app s | TCB Information | |||||
1 | TCB Application Email Address |
S******@nemko.com
|
||||
1 | TCB Scope |
A4: UNII devices & low power transmitters using spread spectrum techniques
|
||||
app s | FCC ID | |||||
1 | Grantee Code |
A3L
|
||||
1 | Equipment Product Code |
LABGEOPA20
|
||||
app s | Person at the applicant's address to receive grant or for contact | |||||
1 | Name |
J****** C********
|
||||
1 | Title |
General Manager
|
||||
1 | Telephone Number |
973-8********
|
||||
1 | Fax Number |
973-8********
|
||||
1 |
j******@samsung.com
|
|||||
app s | Technical Contact | |||||
1 | Firm Name |
Samsung Electronics Co.,Ltd.
|
||||
1 | Name |
S****** J********
|
||||
1 | Physical Address |
416, Maetan 3-dong, Yeongtong-gu
|
||||
1 |
Suwon-si, 443-742
|
|||||
1 |
South Korea
|
|||||
1 | Telephone Number |
82312********
|
||||
1 | Fax Number |
82312********
|
||||
1 |
S******@samsung.com
|
|||||
app s | Non Technical Contact | |||||
1 | Firm Name |
Samsung Electronics Co.,Ltd.
|
||||
1 | Name |
D**** S******
|
||||
1 | Physical Address |
416, Maetan 3-dong, Yeongtong-gu
|
||||
1 |
Suwon-si, 443-742
|
|||||
1 |
South Korea
|
|||||
1 | Telephone Number |
82312********
|
||||
1 | Fax Number |
82312********
|
||||
1 |
d******@samsung.com
|
|||||
app s | Confidentiality (long or short term) | |||||
1 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 | If so, specify the short-term confidentiality release date (MM/DD/YYYY format) | 03/19/2013 | ||||
if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
1 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 | Equipment Class | DTS - Digital Transmission System | ||||
1 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | Immunology Analyser | ||||
1 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 | Modular Equipment Type | Does not apply | ||||
1 | Purpose / Application is for | Original Equipment | ||||
1 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | No | ||||
1 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | No | ||||
1 | Grant Comments | Output power listed is peak conducted. The antenna(s) used for this transmitter must be installed to provide a separation distance of at least 20 cm from all persons and must not be co-located or operating in conjunction with any other antenna or transmitter. End users and installers must be provided with antenna installation and transmitter operating conditions for satisfying RF exposure compliance | ||||
1 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
app s | Test Firm Name and Contact Information | |||||
1 | Firm Name |
Nemko Korea Co.,Ltd.
|
||||
1 | Name |
H**** K********
|
||||
1 | Telephone Number |
82-31********
|
||||
1 | Fax Number |
82-31********
|
||||
1 |
h******@nemko.com
|
|||||
Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15C | 2412.00000000 | 2462.00000000 | 0.1480000 |
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC