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RX only ON-POINT LAM301-01 Instructions For Use Manual

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LOAA(Lab on An Array) Real-Time PCR Instrument
Instructions For Use
LAM301-01
LOAA Analyzer
For in vitro Diagnostic (IVD) Use
Page 1 / 47
IFU-3M001-EN-00 (2021.03.05)

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Summary of Contents for RX only ON-POINT LAM301-01

  • Page 1 LOAA(Lab on An Array) Real-Time PCR Instrument Instructions For Use LAM301-01 LOAA Analyzer For in vitro Diagnostic (IVD) Use Page 1 / 47 IFU-3M001-EN-00 (2021.03.05)

  • Page 2: Table Of Contents

    LOAA(Lab on An Array) Real-Time PCR Instrument Instructions For Use Table of Contents Intended Use of LOAA Analyzer ............................4 Features of LOAA Analyzer ............................. 4 III. Customer and Technical Support Team .......................... 4 Safety Warnings and Precautions ........................... 4 Indicators of LOAA Analyzer ............................
  • Page 3 LOAA(Lab on An Array) Real-Time PCR Instrument Instructions For Use Instructions for Use of LOAA Analyzer .......................... 18 5.1. Dr. PCR Cartridge Kit ............................18 5.2. Preparation before PCR test ..........................18 5.3. PCR test using LOAA Analyzer ........................... 21 5.4.

  • Page 4: Intended Use Of Loaa Analyzer

    LOAA(Lab on An Array) Real-Time PCR Instrument Instructions For Use Intended Use of LOAA Analyzer LOAA Analyzer is Real-time PCR instrument which is an in vitro diagnostic (IVD) medical device used to amplify specific genes (DNA or RNA) designed for use with LOAA Dr. PCR cartridges. PCR reaction data is automatically analyzed by the dedicated software installed in the device and results are delivered to users through on-screen display or export to external memory for further processing.

  • Page 5: Indicators Of Loaa Analyzer

    LOAA(Lab on An Array) Real-Time PCR Instrument Instructions For Use V. Indicators of LOAA Analyzer A. Safety indicator attached on LOAA Analyzer Safety symbol Description CAUTION! Do not operate at low temperature. It may occur malfunction due to condensed water vapor. Warning! Pay attention to the door operation.

  • Page 6: Safety Warnings And Precautions Of Loaa Analyzer

    LOAA(Lab on An Array) Real-Time PCR Instrument Instructions For Use VI. Safety Warnings and Precautions of LOAA Analyzer Warnings and precautions are for proper use and safe operation of the equipment. Users who handle the equipment should observe all the following matters for safety. OPTOLANE Technologies, Inc is not responsible for any failure to comply with the following safety warnings and precautions.

  • Page 7: Precautions On The Operating Environment

    LOAA(Lab on An Array) Real-Time PCR Instrument Instructions For Use C. Precautions on the operating environment (1) Do not place anything near the equipment. (2) Do not install the equipment in a dusty place. Excessive dust may cause equipment failure or damage. (3) Do not install the equipment near a heat source.

  • Page 8: Warnings And Precautions For Using And Maintaining The Product

    LOAA(Lab on An Array) Real-Time PCR Instrument Instructions For Use F. Warnings and Precautions for using and maintaining the product (1) Please use this product for nucleic acid amplification purpose. Do not use the equipment for any purpose other than those specified in the Instructions For Use. (2) Use only the supplied accessories and recommended cartridges.

  • Page 9: Fcc Statement

    LOAA(Lab on An Array) Real-Time PCR Instrument Instructions For Use VII. FCC Statement  15.105 (a) For a Class A digital device or peripheral, the instructions furnished the user shall include the following or similar statement, placed in a prominent location in the text of the manual: LOAA Analyzer has been tested and found to comply with the limits for a Class A digital device, pursuant to part 15 of the FCC Rules.

  • Page 10: Introduction Of Loaa Analyzer

    LOAA(Lab on An Array) Real-Time PCR Instrument Instructions For Use 1. Introduction of LOAA Analyzer 1.1. Intended use of LOAA Analyzer LOAA Analyzer (Model name: On-Point) is Real-time PCR instrument which is an in vitro diagnostic (IVD) medical device used to amplify specific genes (DNA or RNA) designed for use with LOAA Dr. PCR cartridges. PCR reaction data is automatically analyzed by the dedicated software installed in the device and results are delivered to users through on- screen display or export to external memory for further processing.

  • Page 11: Loaa Analyzer Software

    LOAA(Lab on An Array) Real-Time PCR Instrument Instructions For Use Fluorescence intensity at each well is detected by the CMOS photosensor chip at each thermal cycle during PCR amplification. The fluorescence intensity real-time curve is generated and analyzed by the LOAA software in the analyzer to determine if targets are detected at each well.

  • Page 12: Installation Of Loaa Analyzer For Cartridge System

    LOAA(Lab on An Array) Real-Time PCR Instrument Instructions For Use 2. Installation of LOAA Analyzer for Cartridge System 2.1. Installation requirements Choose a location for LOAA Analyzer system with a clean, well-ventilated flat table where you can place LOAA Analyzer. •...

  • Page 13: Appearance Of Loaa Analyzer

    LOAA(Lab on An Array) Real-Time PCR Instrument Instructions For Use 2.3. Appearance of LOAA Analyzer Front Back Name Description ① Bar code scanner 1D/ 2D bar code scanner to read sample ID ② LCD touch screen LCD display with multi-touch function ③...

  • Page 14: Installation Of Loaa Analyzer System

    LOAA(Lab on An Array) Real-Time PCR Instrument Instructions For Use 2.5. Installation of LOAA Analyzer System Unpack the equipment and place it on a solid, flat surface. Connect the equipment power adapter to the DC connector on the back of the equipment (dashed rectangle). Turn on the main power switch at the bottom of the equipment rear panel.

  • Page 15: Loaa Analyzer Device Status

    LOAA(Lab on An Array) Real-Time PCR Instrument Instructions For Use Figure 5. Home screen of LOAA Analyzer (wireless network OFF) Figure 6. Home screen of LOAA Analyzer (Ethernet network ON) For LOAA sample loader POSTMAN, connect provided DC adaptor to USB-C port at the one side of the device (③...

  • Page 16: Operating Principles

    LOAA(Lab on An Array) Real-Time PCR Instrument Instructions For Use 3. Operating Principles LOAA Analyzer is an in vitro diagnostic system that diagnoses targets in the clinical sample by using multiplex real-time PCR to synthesize cDNA from nucleic acids extracted from whole blood, plasma, serum or urine, and to amplify the synthesized cDNA as template.

  • Page 17: Technical Data

    LOAA(Lab on An Array) Real-Time PCR Instrument Instructions For Use 4. Technical Data Specification Item Specification Performance Item Specification sample processing 1 test at a time per LOAA, 1 sample / test Light source 460nm LED Heating ramp rates (max.) 10℃/sec from 60℃...

  • Page 18: Instructions For Use Of Loaa Analyzer

    LOAA(Lab on An Array) Real-Time PCR Instrument Instructions For Use 5. Instructions for Use of LOAA Analyzer Note Cartridge preparation may vary depending on the cartridge type. For specific preparation steps, refer to the Instructions for Use for each Dr. PCR cartridge kit. There are three main steps to take when using LOAA Analyzer system.
  • Page 19 LOAA(Lab on An Array) Real-Time PCR Instrument Instructions For Use 5.2.3. Sample loading into Dr. PCR Cartridge 1) Take the cartridge out from the box and remove the protective sticker on the window. 2) While pressing the cartridge guide at the center of LOAA Sample Loader (POSTMAN) in the direction of the arrow shown in Figure 7 (left image), insert the cartridge into POSTMAN by matching the three grooves at the bottom edge of the LOAA cartridge with the three protrusions at the edge of the POSTMAN top plate (right image).
  • Page 20 LOAA(Lab on An Array) Real-Time PCR Instrument Instructions For Use Figure 10. Operating LOAA Sample Loader 7) The sample is automatically loaded so that uniform volume is injected into the wells in the cartridge. 8) When the sample loading is finished, the LOAA Sample Loader (POSTMAN) automatically stops running and the button will blink in random colors.

  • Page 21: Pcr Test Using Loaa Analyzer

    LOAA(Lab on An Array) Real-Time PCR Instrument Instructions For Use 5.3. PCR test using LOAA Analyzer 5.3.1. ‘Home’ screen of User Interface The LOAA Analyzer's home screen is the main starting point for interacting with the features built into the LOAA Analyzer Graphical User Interface.

  • Page 22: Test Procedure

    LOAA(Lab on An Array) Real-Time PCR Instrument Instructions For Use Table 2. Fuction icons in Record Screen Function icon Description Export report in PDF format Delete test result Sort test results by date and product name Search for product name 5.4.
  • Page 23 LOAA(Lab on An Array) Real-Time PCR Instrument Instructions For Use Loading the cartridge HOME>New Test>Sample ID>Next 1) When entering sample ID operation is done, LOAA Analyzer's front-side shutter opens to load the cartridge, and the cartridge loader comes forward. 2) Place the locked cartridge in the cartridge loader. Note.
  • Page 24 LOAA(Lab on An Array) Real-Time PCR Instrument Instructions For Use 5.4.2. Validating well structures inside the Dr. PCR Cartridge Figure 15. Verifying Cartridge Screen Figure 16. Analyzing Cartridge Screen Cartridge analysis HOME>New Test>Sample ID>Next>Next 1) When you press Next button on the screen, the loader automatically moves back in the equipment and the door is closed.
  • Page 25 LOAA(Lab on An Array) Real-Time PCR Instrument Instructions For Use 2) Press the Fluo. button on the Temperature and Process Cycle screens to switch to the Fluorescent Graph screen during the test†. ※ Fluorescence graph does not appear in “Stage 1” during PCR stage. 3) Press the>...
  • Page 26 LOAA(Lab on An Array) Real-Time PCR Instrument Instructions For Use Figure 20. CH2 Digital PCR Result Screen 7) Press Ch 1 to display the real-time PCR result corresponding to the green channel (Figure 19). Target name, well information and item information are displayed at the top center of the screen. 8) Press Ch 2 to display the real-time PCR result corresponding to the red channel (Figure 20).

  • Page 27: Loaa Analyzer Record Menu

    LOAA(Lab on An Array) Real-Time PCR Instrument Instructions For Use Result Result Screen>Export PDF 1) If you want to save the report, first press the Export PDF button with the USB memory plugged into the USB port on the back of the instrument. 2) A message appears asking if you want to save the test result report to USB memory.
  • Page 28 LOAA(Lab on An Array) Real-Time PCR Instrument Instructions For Use Test history Home>Record>test result Figure 25. Test Result Screen 1) Press the graph view button (①) to switch to the graph view screen. Test history Home>Record>Product name search Figure 26. Product Name Search Screen 1) If you press the “Product Name”...
  • Page 29 LOAA(Lab on An Array) Real-Time PCR Instrument Instructions For Use Test history Home>Record>Align Figure 28. Record Align Screen 1) If you click the sort button, the test history is displayed in ascending or descending order by date and product name. 2) If you press the date and product name button, the arrow changes up/down and is displayed in ascending or descending order.

  • Page 30: Loaa Analyzer Device Setup

    LOAA(Lab on An Array) Real-Time PCR Instrument Instructions For Use 5.6. LOAA Analyzer device setup Setting Home>Setting If a user of LOAA Analyzer presses 'Setting' button on the Home screen, the user can change settings such as hardware setting, language and password. Figure 30.
  • Page 31 LOAA(Lab on An Array) Real-Time PCR Instrument Instructions For Use Setting Home>Setting> Brightness & Sound You can adjust the brightness of LCD screen and the level of speaker sound. Figure 33. Setting Screen – Brightness & Sound Setting Home>Setting>General Info 1) General information set by the administrator is displayed.
  • Page 32 LOAA(Lab on An Array) Real-Time PCR Instrument Instructions For Use Network settings Network>Ethernet 1) On the network setting screen, icon to set Wi-Fi or Ethernet is displayed on the top right. 2) If you select Ethernet, select DHCP or static IP mode on the setting screen.
  • Page 33 LOAA(Lab on An Array) Real-Time PCR Instrument Instructions For Use Setting Home>Settings>Update USB cartridge / report information update 1) Enter the settings on the 'Home' screen and press the Update button on the left. 2) Insert the USB memory containing LOAA cartridge information and/or report information update files into the USB port on the back of the LOAA Analyzer.
  • Page 34 LOAA(Lab on An Array) Real-Time PCR Instrument Instructions For Use 2) After entering information on organization, instrument name of the device and e-mail address of administrator to be changed, press Apply button to save the changes. 3) Press >Close button to move to Home screen. Setting Home>Settings>Administrator mode>Change administrator password 1) Press Administrator password button to move to Change administrator password screen.

  • Page 35: Loaa Analyzer Application Termination

    LOAA(Lab on An Array) Real-Time PCR Instrument Instructions For Use 5.7. LOAA Analyzer Application termination Exit screen If you press power button on the front side of LOAA Analyzer for more than 5 seconds, an exit message box will appear. Press OK to proceed power off sequence of the LOAA Analyzer.

  • Page 36: Precautions In Advance During Work Using Loaa Analyzer

    LOAA(Lab on An Array) Real-Time PCR Instrument Instructions For Use 6. Precautions in advance during work using LOAA Analyzer 6.1. Laboratory safety and biological risks 6.1.1. General precautions LOAA Analyzer device do not have biological risks of their own, but according to the standard for non-clinical test control, it is recommended that all wasted materials be treated as a substance with potential biological risk.
  • Page 37 LOAA(Lab on An Array) Real-Time PCR Instrument Instructions For Use through people's normal activities. Thus, very small amounts (molecules) can be also amplified by PCR in subsequent operation, which may be identified to be positive in LOAA Analyzer device. Handle all broken cartridges as if they could contaminate the work area.
  • Page 38 LOAA(Lab on An Array) Real-Time PCR Instrument Instructions For Use 6.2.4. Decontamination of devices 1) Decontamination of cartridge loaders a. Wear latex gloves on both hands and wipe the inside of the cartridge loader with a clean, soft cotton swab. Be careful not to touch the measuring part.

  • Page 39: Prevention Maintenance And Troubleshooting

    LOAA(Lab on An Array) Real-Time PCR Instrument Instructions For Use 7. Prevention Maintenance and Troubleshooting 7.1. Introduction This chapter provides step-by-step guidelines for users to perform basic maintenance, updates and troubleshooting for LOAA Analyzer. Caution: Before performing the regular cleaning steps on the LOAA Analyzer, wear appropriate personal protective equipment, switch off the device and unplug the power cable.

  • Page 40: Troubleshooting When An Error Occurs

    LOAA(Lab on An Array) Real-Time PCR Instrument Instructions For Use 7.5. Troubleshooting when an error occurs [Hardware troubleshooting] The following table shows solutions to resolve potential symptoms and problems with LOAA Analyzer hardware. If the problem persists after applying the recommended solution, please contact the technical support team for assistance. If there is any error message popped up, please, refer to [Diagnostic error] section for recommended further actions.
  • Page 41 LOAA(Lab on An Array) Real-Time PCR Instrument Instructions For Use [Barcode scanner] The barcode scanner is pre-programmed to read the cartridge test items and etc. If the problem persists even after applying the recommended solutions listed in the table below, please contact the technical support team for assistance.
  • Page 42 LOAA(Lab on An Array) Real-Time PCR Instrument Instructions For Use [Diagnostic error] Diagnostic errors are often used by technical support representatives to resolve device problems. The table below lists potential error messages and possible solution. If the error persists even after applying the recommended solution, contact the technical support team for assistance.
  • Page 43 LOAA(Lab on An Array) Real-Time PCR Instrument Instructions For Use OM_00533 OM_00534 OM_00535 OM_00536 OM_00537 OS_00600 OS_00601 UC_00001 UC_00002 UC_00003 Please, update the cartridge information file with the latest version. UC_00004 UC_00005 UC_00006 UC_00007 Please, contact the technical support team for assistance UC_00008 UC_00009 UM_00010...
  • Page 44 LOAA(Lab on An Array) Real-Time PCR Instrument Instructions For Use UD_00126 No results found. UD_00127 UD_00128 UP_00201 UP_00202 UP_00203 UP_00204 UP_00205 UP_00206 UP_00207 UP_00208 UP_00209 UP_00210 UP_00211 Please, contact the technical support team for assistance. UP_00212 UP_00213 UP_00214 UP_00215 UP_00216 UP_00217 UP_00218 UP_00219...

  • Page 45: Quality Guarantee

    LOAA(Lab on An Array) Real-Time PCR Instrument Instructions For Use 8. Quality Guarantee We, OPTOLANE Technologies, Inc. warrants the materials and the defects during the production process for 1-year warranty period from the date when the customer takes over the product. Accessories are considered as a consumable, so quality is guaranteed for only 3 months.

  • Page 46: Symbols

    LOAA(Lab on An Array) Real-Time PCR Instrument Instructions For Use 9. Symbols Symbol Meaning Symbol Meaning Direct current Catalog number Date of manufacture Serial Number Manufacturer Caution WEEE Symbol Keep away from rain Operator's manual; In vitro diagnostic medical device Operating instructions CE Marking FCC Logo...
  • Page 47 LOAA(Lab on An Array) Real-Time PCR Instrument Instructions For Use OPTOLANE Technologies, Inc. 6F, 20, Pangyoyeok-ro 241beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do, 13494, Republic of Korea Tel: +82-31-881-9600 / Fax: +82-31-881-9611 / Email: mkt@optolane.com / Website: www.optolane.com Page 47 / 47 IFU-3M001-EN-00 (2021.03.05)

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