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.
LOAA(Lab on An Array) Real-Time PCR Instrument Instructions For Use Table of Contents I. Intended Use of LOAA Analyzer...................................................................................................................................... 4 II. Features of LOAA Analyzer ............................................................................................................................................. 4 III. Customer and Technical Support Team ...................................
LOAA(Lab on An Array) Real-Time PCR Instrument Instructions For Use 5. 6. 7. 8. 9. Instructions for Use of LOAA Analyzer .......................................................................................................................... 18 5.1. Dr. PCR Cartridge Kit .......................................................................................................................................... 18 5.2. Preparation before PCR test ......................................................
LOAA(Lab on An Array) Real-Time PCR Instrument Instructions For Use I. 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.
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. Be careful when open and close the door. Do not force open or close the door. WARNIG! Risk of electrical shock! Do not disassemble the equipment. There is a risk of electric shock.
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. A.
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. There is a risk of fire. (4) Do not install the equipment near water or damp places. It may cause electric shock, fire or equipment failure.
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. (3) Do not modify or delete the equipment-related information displayed on the equipment.
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.
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.
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. 1.3.1. LOAA Sample Loader (Model name: POSTMAN) and Dr. PCR Cartridge Interaction Before starting the test, Dr.
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. • Keep space of at least 15 cm between the product and the wall. • Power specifications: 100~240 Vac, 50/60Hz 1.3A (Output: 24 Vdc, 3.75A) use a rated adaptor.
LOAA(Lab on An Array) Real-Time PCR Instrument Instructions For Use 2.3. Appearance of LOAA Analyzer Front No.
LOAA(Lab on An Array) Real-Time PCR Instrument Instructions For Use 2.5. Installation of LOAA Analyzer System 1) Unpack the equipment and place it on a solid, flat surface. 2) Connect the equipment power adapter to the DC connector on the back of the equipment (dashed rectangle). 3) Turn on the main power switch at the bottom of the equipment rear panel. 4) Start the LOAA Analyzer by pressing the power button on the front center for about 4 seconds.
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) 7) For LOAA sample loader POSTMAN, connect provided DC adaptor to USB-C port at the one side of the device (③ in section 2.4). Turn on the power switch at the same side with USB-C ports (④ in section 2.4). Once power is supplied, activating button at the top surface (② in section 2.4) will light in green color. 2.
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.
LOAA(Lab on An Array) Real-Time PCR Instrument Instructions For Use 4. Technical Data Specification Item Specification Performance Performance Item sample processing Light source Heating ramp rates (max.) Specification 1 test at a time per LOAA, 1 sample / test 460nm LED Cooling ramp rates (max.) 5℃/sec from 95℃ to 60℃ Temperature accuracy Maximum power consumption Within ±0.
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. 1) Inject and dispense the sample mixture into cartridge using LOAA Sample Loader (Model Name: POSTMAN).
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.
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. (it takes about 60 seconds) 9) Press the cartridge guide toward the center to release the cartridge from POSTMAN (Figure 11). Figure 11. Separate Dr.
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. There are two main buttons (①, ②) on the home screen. Table 1. Home screen components LOAA touch screen OSD (On-Screen Display) No. Name Description ① Start test (New Test) It is used to start PCR test.
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. Test Procedure 5.4.1. Enter sample ID Figure 13. Enter Sample ID Screen Enter sample ID HOME>New Test 1) When touch New test, sample ID entering menu will appear. 2) On the screen, there are 5 input boxes where user can enter ID’s of samples.
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. The cartridge must be locked and there must not be a gap between the top/bottom parts of the cartridge case and the red rubber ring at the center when viewed from the side.
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. 2) It automatically checks the cartridge status (completed within about 30 seconds).
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> Stop button to terminate the test in the middle of run. The intermediate result of the stopped test will be deleted. Test Result Test Result Screen Figure 18.
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). Target name, well information and item information are displayed at the top center of the screen.
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. If you select OK, it is saved to the USB memory (Figure 22). Result Result Screen>Back Figure 23.
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” part or the magnifying glass icon button, the input keyboard is displayed on the screen.
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.
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. Setting Screen Setting Home>Setting>Language 1) A screen for selecting the desired language is displayed. 2) Press the language button you want to set and press OK button.
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. - Organization - Instrument Name - Admin E-mail 2) Press >X button to move to Home screen. Figure 34.
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. 3) If you select DHCP, IP, Gateway, DNS1 and DNS 2 text boxes are disabled and the result of connection attempt is displayed as a message.
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. 3) Press the Update button on the right to start update.
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.
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. Figure 36. Power Off Screen Page 35 / 47 IFU-3M001-EN-00 (2021.03.
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. 1) Follow all safety instructions printed or attached to the LOAA Analyzer devices.
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. Biological risk: If the cartridge contains potentially infectious substance, there is a risk of biological contamination as well as sample contamination. 6.2.1.
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. b. Dispose of used cotton swabs with care not to contaminate elsewhere. c. Do not disassemble the equipment or immerse it in water or cleaning solution. Also, do not clean it with water or other solutions.
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. 7.2.
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.
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. Symptom Barcode scan performed not • • • Available solution Reposition the barcode and then scan again. Clean the barcode scanner.
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.
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 UC_00004 UC_00005 UC_00006 UC_00007 UC_00008 UC_00009 UM_00010 UM_00011 UM_00012 UM_00013 UM_00014 UM_00015 UM_00016 UM_00017 UR_00020 UR_00021 UR_00022 UR_00023 UR_00024 UR_00025 UR_00026 UR_00027 UR_00028 UD_00101 UD_00102 UD_00103 UD_00104 UD_00105 UD_00106 UD_00107 UD_00108 UD_00109 UD_00110 UD_00111 UD_00112 UD_00113 UD_00114 UD_00115 UD_00116 UD
LOAA(Lab on An Array) Real-Time PCR Instrument Instructions For Use UD_00126 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 UP_00212 UP_00213 UP_00214 UP_00215 UP_00216 UP_00217 UP_00218 UP_00219 UP_00220 UP_00221 UH_00301 UH_00302 UH_00303 US_1005 US_1006 US_1010 US_1011 US_1012 US_1013 US_1014 US_1015 US_1016 US_1017 US_1018 US_1022 No results found. Please, contact the technical support team for assistance.
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. If defects occur after the warranty period, shipping and handling costs may be charged by OPTOLANE Technologies, Inc.
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; Operating instructions In vitro diagnostic medical device CE Marking (IVD, RED) FCC Logo EU Representative NEMKO listing mark for Canada and the USA Caution: Federal Law restricts this device to sale by or on the order of a licensed practitioner(U.
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.
