RX only ON-POINT LAM301-01 User manual

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

Instructions For Use
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IFU-3M001-EN-00 (2021.03.05)
LOAA(Lab on An Array) Real-Time PCR Instrument
Table of Contents
I. Intended Use of LOAA Analyzer ...................................................................................................................................... 4
II. Features of LOAA Analyzer ............................................................................................................................................. 4
III. Customer and Technical Support Team .......................................................................................................................... 4
IV. Safety Warnings and Precautions ........................................................................................................................... 4
V. Indicators of LOAA Analyzer ........................................................................................................................................... 5
A. Safety indicator attached on LOAA Analyzer ........................................................................................................... 5
B. Electric indicator of LOAA Analyzer ......................................................................................................................... 5
C. Environmental indicator of LOAA Analyzer .............................................................................................................. 5
VI. Safety Warnings and Precautions of LOAA Analyzer .............................................................................................. 6
A. Precautions for using the equipment ....................................................................................................................... 6
B. Precautions for electrical environment .................................................................................................................... 6
C. Precautions on the operating environment .............................................................................................................. 7
D. Warnings and Precautions on the equipment installation ....................................................................................... 7
E. Warnings and Precautions for operating the equipment ......................................................................................... 7
F. Warnings and Precautions for using and maintaining the product .......................................................................... 8
G. Precautions when moving the equipment ............................................................................................................... 8
H. Warnings on Biological and Chemical Hazard Safety ............................................................................................. 8
VII. FCC Statement ........................................................................................................................................................ 9
1. Introduction of LOAA Analyzer ...................................................................................................................................... 10
1.1. Intended use of LOAA Analyzer .......................................................................................................................... 10
1.2. Use restrictions ................................................................................................................................................... 10
1.3. Dr. PCR Cartridge ............................................................................................................................................... 10
1.4. LOAA Analyzer Software .................................................................................................................................... 11
2. Installation of LOAA Analyzer for Cartridge System ...................................................................................................... 12
2.1. Installation requirements ..................................................................................................................................... 12
2.2. LOAA Analyzer System Components ................................................................................................................. 12
2.3. Appearance of LOAA Analyzer ........................................................................................................................... 13
2.4. Appearance of LOAA Sample Loader (Model name: POSTMAN) ..................................................................... 13
2.5. Installation of LOAA Analyzer System ................................................................................................................ 14
2.6. LOAA Analyzer Device status ............................................................................................................................. 15
3. Operating Principles ...................................................................................................................................................... 16
3.1. Basics of PCR ..................................................................................................................................................... 16
4. Technical Data ............................................................................................................................................................... 17

Instructions For Use
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5. 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. Test Procedure .................................................................................................................................................... 22
5.5. LOAA Analyzer record menu .............................................................................................................................. 27
5.6. LOAA Analyzer device setup .............................................................................................................................. 30
5.7. LOAA Analyzer Application termination .............................................................................................................. 35
6. Precautions in advance during work using LOAA Analyzer .......................................................................................... 36
6.1. Laboratory safety and biological risks................................................................................................................. 36
6.2. Decontamination and cleaning procedures ........................................................................................................ 36
7. Prevention Maintenance and Troubleshooting .............................................................................................................. 39
7.1. Introduction ......................................................................................................................................................... 39
7.2. General maintenance ......................................................................................................................................... 39
7.3. Device setup and management .......................................................................................................................... 39
7.4. Error reporting tool .............................................................................................................................................. 39
7.5. Troubleshooting when an error occurs ............................................................................................................... 40
8. Quality Guarantee ......................................................................................................................................................... 45
8.1. Limited warranty and exclusion .......................................................................................................................... 45
8.2. Request for warranty service .............................................................................................................................. 45
9. Symbols ......................................................................................................................................................................... 46

Instructions For Use
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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. This device is limited to professional use only.
II. Features of LOAA Analyzer
LOAA Analyzer is a diagnostic device to detect specific genes (DNA or RNA) of various target diseases by analyzing PCR
reaction data from the CMOS photo sensor-based cartridge. It is equipped with a thermal controller to perform thermal
cycling of PCR reaction, processing blocks and software to control the workflows of raw data acquisition from PCR reaction,
raw data analysis, result calculation for diagnosis. It is also equipped with 5.5-inch touch LCD display for user to
control/check the device operations and USB port, WiFi module to communicate with other devices.
III. Customer and Technical Support Team
Website: www.optolane.com
E-mail: [e-mail]
Address: 6F, 20, Pangyoyeok-ro 241 beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do, 13494, Republic of Korea
Phone: [phone]
Fax: [phone]
For customers outside of Republic of Korea, please contact your local sales representative or authorized distributors first
for customer and technical support.
IV. Safety Warnings and Precautions
1) This device is a medical device and is not intended for any purposes other than in vitro diagnosis.
2) This document should only be used for the purpose of operating the LOAA Analyzer.
3) Before using this device, be sure to read the formal manual carefully and check the components included in the product.
4) No part of this document may be reproduced or transmitted in any form or by any means, electronic or mechanical, for
any purpose, without the express written permission of OPTOLANE Technologies, Inc.
5) Keep the device in the specified working sequence. If the device is used in a manner not specified by OPTOLANE
Technologies, Inc, the protective function of the device may be impaired.
6) Disposable cartridges used in the experiment should be handled in accordance with the instructions for use and be
disposed of in the manner prescribed by law.
7) All test procedures should follow the safety rules of each testing laboratory.

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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.
Warning; Hot surface
To warn of a hot surface
B. Electric indicator of LOAA Analyzer
Symbol and indicator
Description
Indicates the ‘ON/OFF’ switch of the main power.
C. Environmental indicator of LOAA Analyzer
Symbol and indicator
Description
Do not dispose of LOAA Analyzer as unsorted waste.
In order to minimize the environmental impact of wasted
electric and electronic equipment, please comply with
applicable laws and regulations on wastes.

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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. Precautions for using the equipment
(1) Check whether the power cord is connected to the external power source (100-240V~, 50/60Hz), and
whether it is properly installed in the equipment. Incorrect connection of the power cord may cause damage
or failure of the equipment when the equipment is turned on.
(2) This equipment is used for nucleic acid amplification, so please use it for the proper purpose.
(3) Do not turn off the power or unplug the power cable when the equipment is running. An error may occur,
causing equipment to fail or affecting the results of the experiment.
(4) Install the equipment on a flat surface.
(5) Do not drive the equipment with wet hands as it may cause electric shock or equipment failure. When
touching the power cord, work with water-free hands as well.
(6) If the user makes a mistake, including the use of inappropriate accessories, or if the equipment is forcibly
stopped during normal use, the equipment may be stopped.
(7) Do not place anything on the front and back of the equipment. Blocking the airflow of the cooling fan may
reduce the cooling performance of the equipment.
(8) Do not insert foreign objects into the ventilation openings on the front, rear, or life side of the equipment.
The performance of the cooling fan may be deteriorated due to foreign objects, causing the equipment to
overheat and causing a fire.
B. Precautions for electrical environment
(1) Do not use the equipment with a damaged power cord. Overheating the power cord may cause electric
shock or fire.
(2) Do not connect multiple devices to one external power source. Overheating may cause fire.
(3) When connecting or disconnecting the power cord from an external power source, make sure that your
hands are dry. Moisture may cause electric shock.
(4) Use only the power cord supplied by the company.
(5) The socket outlet should be installed at least 1.5 m from the sink or basin.
(6) Do not repair the power outlet with insulating tape. Moisture can penetrate into the tape.
(7) If you use a power cord other than that supplied by the company, you must use the one that meets the
rated voltage and current.
(8) The plug must be suitable for the socket outlet.
(9) To prevent fire due to overheating, disconnect the power cord from LOAA Analyzer when not using it for a
long time.
(10) Use of improper high-voltage power may damage the wiring system of the equipment, which causes fire.
Before applying power to the equipment, make sure that the power supplied to the laboratory matches the
power of the equipment.

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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.
(5) Do not install the equipment near corrosive or flammable gases. If a corrosive or flammable gas leaks, do
not touch the power cord, but open the window for ventilation. Sparks on the power cord may cause fire
and explosion.
(6) Do not disassemble or modify the equipment in any way. It may cause fire, electric shock or equipment
failure, and in this case, the equipment cannot be guaranteed.
D. Warnings and Precautions on the equipment installation
(1) Do not install this equipment in a place exposed to direct sunlight.
(2) Please install the equipment on a stable flat surface.
(3) When installing the equipment, install it at least 15 cm from the nearest wall.
E. Warnings and Precautions for operating the equipment
(1) Remove dust around the power plug and connect it securely so that the plug does not shake. Incomplete
connections may cause fire.
(2) Operate the equipment at a temperature between 15℃~30℃(59~86℉). Exposure of the equipment at
high temperature may affect the equipment, causing inaccurate results.
(3) Operate the equipment in the recommended humidity range (20 ~ 80 %, free of moisture condensation).
Moisture may cause equipment corrosion or failure.
(4) Do not place anything on the side or back of the equipment. It may cause equipment failure.
(5) This equipment contains precision machined parts. Do not drop or shake it violently. It may break and
damage the safety of the equipment.
(6) If the equipment is not used for a long time, please turn off the power of the equipment and block the
external power supply. Otherwise, there is a risk of overheating and fire.
(7) It may cause burns to your hands or body. Do not manually open the cover during operation.
(8) If you touch ventilation openings or parts of equipment in operation, be careful as your hands may be
pushed, torn or subjected to static electricity shock.

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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.
(4) When using the touch LCD screen, do not use your fingernails or other sharp materials as they may
cause damage to the product.
(5) Do not use a strong surfactant or solvent to clean the surface of the equipment. The color of the
equipment may change. If this kind of material spills onto the equipment, wipe it off with soft cloth
immediately.
(6) Do not store the equipment in a humid place. If stored in such a place, it may be damaged by
moisture, and the damaged equipment cannot be guaranteed. In this case, repair may not be
possible.
(7) If the equipment is disassembled or remodeled, it cannot be guaranteed, and the service may be
refused.
(8) Do not disconnect the power cord while using the equipment. It may cause equipment failure.
(9) If there is a burning smell or if the equipment in operation is very hot, stop operating the equipment
immediately and contact customer service or your sales representative.
(10) Do not drop the equipment or apply any impact on it. The equipment may be damaged directly and
may not be guaranteed.
G. Precautions when moving the equipment
Improper lifting of the equipment may cause serious and permanent injuries to the waist. Depending on the
weight, more than two people may be required to move the equipment.
H. Warnings on Biological and Chemical Hazard Safety
(1) Biological samples such as tissues, body fluids and blood derived from human body may potentially carry
infectious diseases. Be sure to follow the regulations in your area and country. Wear safety goggles,
laboratory gowns and gloves during the experiment.
(2) Before handling chemicals, be sure to read the Material Safety Data Sheets (MSDS) issued by the
manufacturer carefully and check the relevant precautions.
(3) Before making changes to the contents of equipment components and reagents, always check which
chemicals have been used. Wear appropriate safety goggles, laboratory gowns and gloves when using
the equipment.
(4) Minimize contact with chemicals. Wear personal protective equipment when handling chemical
substances.

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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. These limits are designed to provide reasonable protection against harmful interference when the equipment
is operated in a commercial environment. This equipment generates, uses, and can radiate radio frequency energy and, if
not installed and used in accordance with the instruction manual, may cause harmful interference to radio communications.
Operation of this equipment in a residential area is likely to cause harmful interference in which case the user will be required
to correct the interference at his own expense.
 This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device
may not cause harmful interference, and (2) this device must accept any interference received, including interference
that may cause undesired operation.
 FCC Caution: Any changes or modifications not expressly approved by the party responsible for compliance could void
the user’s authority to operate this equipment.
 For product available in the USA/Canada market, only channel 1~11 can be operated. Selection of other channels is
not possible.
 This device is going to be operated in 5.15~5.25GHz frequency range, it is restricted in indoor environment only.
 IMPORTANT NOTE:
FCC Radiation Exposure Statement:
LOAA Analyzer complies with FCC radiation exposure limits set forth for an uncontrolled environment.
LOAA Analyzer should be installed and operated with minimum distance 20cm between the radiator & your body.
LOAA Analyzer and its antenna(s) must not be co-located or operation in conjunction with any other antenna or transmitter.

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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. This device is limited to professional use only.
Figure 1. Appearance of LOAA Analyzer (Model name: On-Point)
1.2. Use restrictions
• This product can only use LOAA cartridges.
• For in vitro diagnostic medical devices only
• Use only the supplied adapter when connecting the device to a power source
• Do not reuse cartridges related to errors, incomplete tests or invalid results
1.3. Dr. PCR Cartridge
LOAA PCR Cartridge (Figure 2) is a disposable and closed-system product containing primers and probes required for
amplification and detection of target nucleic acid samples. The cartridge mainly consists of a CMOS photosensor with a
well array where nucleic acid is amplified, and fluorescence is detected, a microfluidic component where PCR mixture
solution is delivered into each well, and a solid plastic body. Real-time gene amplification (including reverse transcription
PCR) and results analysis are performed through a reader system called LOAA Analyzer. Since all the information for a
diagnostic item and the PCR protocol is written inside the CMOS semiconductor chip, by simply loading the cartridge in the
analyzer real-time PCR can start without any handy PCR parameter setting.
Figure 2. Dr. PCR Cartridge

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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. PCR cartridge should be loaded into LOAA Sample Loader (Model name: POSTMAN) in order
to deliver appropriated amount of sample solution into the well array. Put the liquid reagent prepared with the purified nucleic
acid and PCR reagents into the cartridge injection port using a disposable pipette. When you press the activating button on
the LOAA Sample Loader (Model name: POSTMAN), the sample mixture automatically enters the individual well inside the
cartridge and the operation stops automatically when the injection is complete.
1.3.2. Interaction between LOAA Analyzer and cartridge
The mixture of purified nucleic acid and sample master mix amplifies both the control material and the target identified by
the cartridge. Cartridge and equipment perform reverse transcription and/or thermal cycling (heating and cooling of the
solution) for PCR reaction. Thermal cycle control parameters are set appropriately according to the associated test protocol
for each specific reagent cartridge and sample type.
1.3.3. PCR reaction analysis
To identify the target in a positive PCR reaction, LOAA performs a fluorescence amplification curve analysis. During each
PCR cycle, multiple images of PCR well array are captured and fluorescence levels of valid wells are calculated and
fluorescence amplification curve is generated at each PCR cycle by the software installed in LOAA. Based on this curve, if
it turns out to be a valid PCR reaction through PCR control reaction result analysis, PCR reaction result that which targets
are detected in the sample is delivered to user. Validation of proper operation of the optical system included in LOAA
Analyzer is monitored through device self-check operation and cartridge PCR control reactions.
1.4. LOAA Analyzer Software
LOAA Analyzer software provides the system controls the operation of LOAA Analyzer. The software also collects, analyzes,
and archives data generated by the device. The analysis results are presented in the test result table. Detailed information
on the features and operation of LOAA Analyzer software is provided in Chapter 5.

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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 Analyzer complies with the emission and immunity requirements of IEC 61326-1. It is recommended that you evaluate
the electromagnetic environment before operating the device.
Caution!
Do not position the LOAA Analyzer and LOAA Sample Loader in such a way that it is difficult to disconnect
the power adapter and cord set from the devices.
2.2. LOAA Analyzer System Components
Each system is provided with devices, Instructions For Use, DC adapter and cord. The contents of each box are shows in
Figure 3.
Figure 3.LOAA Analyzer Components
Note The LOAA Sample Loader (Model name: POSTMAN) is delivered separately in its own box. USB-A to USB-C power
cable is provided and any USB power adaptor with output power rating of 5V, 1A or more can be used as a power supply
for LOAA Sample Loader (Model name: POSTMAN).

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2.3. Appearance of LOAA Analyzer
Front
Back
No.
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
Cartridge loader door Cover for cartridge loading area
④
Power button Equipment power ON/OFF button
⑤
Right-side vent Inhale external air for cooling module
⑥
Cartridge loader Tray to install cartridge and move to/from inside of the
device
⑦
Back-side vent Exhausting warm air from cooling module
⑧
Eject Button / Reset button Buttons for cartridge manual eject / device reset
⑨
USB port USB memory connection port for data export or software
update
⑩
Ethernet port RJ45 ethernet cable connection port
⑪
DC adapter port 24 V DC power input for the device
⑫
Main power switch Control main power supply to the device
2.4. Appearance of LOAA Sample Loader (Model name: POSTMAN)
Front
Back
No.
Name
Description
①
Lid Dust protection cover
②
Operation switch Equipment operation switch
③
USB C-Type power supply plug hole Equipment power terminal
④
Power switch Equipment power ON (I) / OFF (O) switch
①
②
④
③

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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.
5) Set up the initial environment settings such as language, network configuration, date/time, brightness, volume,
administrator password, user password, and general information. You need to set it up once at the beginning.
※ Initial environment settings can be reconfigured later in the setting menu. (See Section 5.6)
6) When the LOAA Analyzer is powered on, the login screen (Figure 4) is displayed and you can go to the main
screen after entering correct user password (Figure 5, Figure 6). User password has been set in initial configuration
step.
Figure 4. Login screen of LOAA Analyzer (Network connection OFF)
※ For how set a password, refer to Section 5.6.
※ For network setting method, refer to Section 5.6.

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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.
2.6. LOAA Analyzer Device status
The status is displayed on the front LED light of the LOAA Analyzer.
- Rainbow color random flashing: device is not in PCR operation
- Green flashing: device is in PCR operation
Please keep the packing materials and the box as the equipment may be shipped to the OPTOLANE Technologies, Inc. for
A/S.
Before requesting A/S, be sure to check Chapter 7 preventative maintenance and troubleshooting described in the
Instructions For Use.
If the problem is not solved, please contact our Customer Support Team ([phone]) or your sales representative.

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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.
Users of LOAA Analyzer system install the cartridge to the LOAA Sample Loader POSTMAN, inject the extracted nucleic
acid sample to the cartridge, place it on the device and start the test.
LOAA Analyzer interacts with a cartridge to amplify the RNA or DNA sequence of the pathogens in the sample under
examination. The resultant PCR products are automatically measured and analyzed by LOAA Analyzer to display the test
results.
3.1. Basics of PCR
Polymerase chain reaction (PCR) is a process that produces billions of copies of DNA. If the target is RNA, reverse
transcription is performed at 50°C to synthesize cDNA. Then DNA double strand is split into two single strands at 95°C and
the probe is bound to the specific gene sequence at 60°C. While duplicating a specific gene sequence, the fluorescence
level will increase and it is measured in real time. While temperature cycle changes alternately between 95°C and 60°C,
fluorescence measurement is performed periodically at the specific step during each cycle.

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4. Technical Data
Specification Item
Specification
Performance
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℃ to 95℃
Cooling ramp rates (max.) 5℃/sec from 95℃ to 60℃
Temperature accuracy Within ±0.5℃
Maximum power consumption Less than 90 W
Operating conditions
• Temperature: 15℃~30℃
• Relative humidity: 20 to 80% (noncondensing)
• Ambient pressure: 700hPa to 1,060hPa
• Indoor use only
Storage conditions
• Temperature: 2℃ to 50℃ (35.6℉ to 122℉) in manufacturer’s package
• Relative humidity: 20% to 80% humidity
• Ambient pressure: 700hPa to 1,060hPa
Transport conditions
• Temperature: -10℃ to 50℃ (14℉ to 122℉) in manufacturer’s package
• Relative humidity: 10% to 85% humidity
• Ambient pressure: 700hPa to 1,060hPa
Power requirements • 100-240V~ 50~60Hz 1.3A input, 24 Vdc. output, 3.75A, 90W
Dimensions and weight
• 242 x 253 x 206 mm (H x D x W)
• Total weight: 4.1 Kg
- Analyzer: 3.2 Kg (With adaptor: 3.7 Kg)
- LOAA Sample Loader (Model name: POSTMAN) 0.34 Kg
EMC requirements LOAA Analyzer system complies with the emission and immunity requirements of IEC 61326-
1: 2012 (Class A).
CPU Cortex-A53 Octa core 1.4 GHz
Storage and Memory
• 2GB DDR3
• 8GB eMMC
• 1TB HDD
Interface and peripherals
• One Ethernet network interface
• 2 USB ports for storage (Located on the lower back)
• Wi-Fi antenna: 5Ghz/2.4Ghz
Display
5.5” TFT LCD with touch
• 68.04x120.96mm active area
• 1920x1080 FHD resolution
• multi-touch support
Operating system Android 7.1 (Nougat)
Software version 3.0.0
Overvoltage category II
Pollution degree 2

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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).
2) Install the Cartridge to the LOAA Analyzer and operate the device.
3) Check the PCR results.
5.1. Dr. PCR Cartridge Kit
Each kit contains the reagents and cartridges needed for PCR test to be performed in LOAA Analyzer. Components vary
depending on the kit type. Please refer to the Instructions For Use or Quick Guide for specific preparation and test
procedures.
Note. Cartridge may vary depending on the kit type.
Caution:
Do not use the components of one LOAA cartridge kit to prepare another type of LOAA cartridge. Components
are specific to each LOAA cartridge.
5.2. Preparation before PCR test
5.2.1. General precautions
It is recommended that the handling of potentially infected samples be carried out in a biological safety cabinet or hood, or
behind a protective shield. Overall procedure starts with DNA/RNA extraction and purification using commercially available
prep kit. Recommended samples for LOAA Diagnosis are nucleic acids extracted from whole blood, plasma and serum.
The mixed solution is loaded into cartridge by using sample loader. Finally, the sample loaded cartridge is inserted in the
analyzer and starts test. The detail steps starting from the sample loading is addressed below.
One of the most important guidelines related to tests using PCR is to prevent contamination.
The followings are some of important rules.
1) Sample collection, cartridge injection, cartridge loading and LOAA Analyzer device operation must be performed
in separate locations or work areas.
2) Do not leave the work area or return to the previous work area without completing the decontamination procedure
at first (cleaning the area and changing protective clothes and gloves).
3) Prepare only one cartridge at a time.
4) Always dispose of used cartridges or cartridges in contact with samples in biological hazardous waste containers.
Replace gloves after handling used cartridges.
LOAA cartridges are stored in individually packed pouches. Always check the availability and operation of LOAA Analyzer
device before removing the individual package to install the cartridge.
5.2.2. Preparation of the LOAA Analyzer and LOAA Sample Loader
LOAA Analyzer and LOAA sample loader should be ready for PCR test by following the operation steps described in 3.4.

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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).
Figure 7. Plating description 1
3) Fully seat the cartridge on POSTMAN by pressing it down until it clicks.
4) While holding the top of the cartridge lid with both hands, turn the lid in the clockwise direction shown in Figure 8
until it clicks. If it is done correctly, the lid will be locked, and will not rotate in counterclockwise direction. Also,
check that the logo ( ) at the top of the cartridge lid is aligned with the black arrow (▼) at the top center of
POSTMAN.
Figure 8. Plating description 2
5) Open the red rubber at the cartridge inlet. Inject the sample to test into the cartridge (Figure 9 for injection hole
location) using a disposable pipette and close the red rubber.
Figure 9. Dr. PCR Cartridge inlet location
6) Press the activating button (red circle in Figure 10) on the LOAA Sample Loader (POSTMAN) for about 1 second.
Then, activating button will turn into solid red color and pump operation sound will be heard.

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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. PCR Cartridge
10) Hold the cartridge with both hands and lock it in place by pressing the top and bottom cases in various directions
as shown in Figure 12.
Figure 12. Dr. PCR Cartridge Lock direction
5.2.4. Starting to operate LOAA Analyzer
LOAA software includes:
1) Guides the user to place the cartridge in the LOAA Analyzer
2) Checking the problems of the cartridge installed and,
3) Depending on cartridge types, importing cartridge information from the memory inside the cartridge or input the
information from user. To start test, touch New Test on the home screen.