2AZBMIAAF20Fluorimetric Immunoassay Analyzer

Copyright © 2018 GenBody Inc. The hardware and software referred to in this User Manual are protected under the copyright law. Unless used for making a software copy for approved use in accordance with the copyright law, no information contained in this User Manual may be reproduced in whole or in part without the prior written permission of GenBody Inc. The information and specifications in this User Manual are subject to change without notice. GenBody Inc. Page 2 / 28 APPENDIX EXPLANATION OF LABEL SYMBOLS GenBody Inc. Page 3 / 28 APPENDIX The FCC/IC Compliance Statement 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. This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: Reorient or relocate the receiving antenna. Increase the separation between the equipment and receiver. Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. Consult the dealer or an experienced radio/TV technician for help. Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment. GenBody Inc. Page 4 / 28 The IC Compliance Statement This device contains licence-exempt transmitter(s)/receiver that comply with Innovation, Science and Economic Development Canada's licence-exempt RSS(s). Operation is subject to the following two conditions: (1) This device may not cause interference. (2) This device must accept any interference, including interference that may cause undesired operation of the device. Cet appareil contient des emetteurs / recepteurs exempts de licence qui sont conformes aux RSS exempts de licence d'Innovation, Sciences et Developpement economique Canada. Son fonctionnement est soumis aux deux conditions suivantes: (1) Cet appareil ne doit pas provoquer d'interferences. (2) Cet appareil doit accepter toute interference, y compris les interferences qui peuvent provoquer un fonctionnement indesirable de l'appareil. GenBody Inc. Page 5 / 28 Confiscope F20 is used for human diagnosis. Confiscope F20V is used for veterinary diagnosis. -Table of Contents - 1. Warnings and Precaution for Safety 1.1 Warnings and Precaution for Safety 1.2 Precautions for Installation the Product 1.3 Precautions before Use 1.4 Precautions during Use 1.5 Precautions for Storing and Managing the System after Use 2. Product Introduction 2.1 Intended Use 2.2 Principle of Analysis 2.3 Product Components 2.4 Parts Description 3. Installation and Start 3.1 Powering on the system 3.2 Powering off the system 4. Test 4.1 Start the Test 4.2 Reading 4.3 Test Result 5. Data Management 5.1 Test Records 5.2 USB Backup 5.3 Delete 6. Settings 6.1 General Setup 6.1.1 Brightness 6.1.2 Date & Time 6.1.3 Key Sound GenBody Inc. Page 6 / 28 6.1.4 Battery Alarm 6.1.5 Incubation Alarm 6.1.6 Equipment Reset 6.1.7 Sleep Timer 6.2 Device & Update 7. Cleaning 8. Trouble Shooting 9. Other Information 9.1 System Specification 9.2 System Characteristics 9.3 Product Service 1. Warnings and Precaution for Safety 1.1 Warnings and Precaution for Safety 1.1.1 For safety purposes, please ensure to read user manual thoroughly before using this device. 1.1.2 In this user manual, no calibration of the product, repair or maintenance stated. In the event of technical issues, please contact the authorized dealer or GenBody Inc. for service. 1.1.3 Do not disassemble, repair or modify the machine without any permission. 1.1.4 GenBody is not responsible for malfunctions and damage to the product caused by irregular operation that is not mentioned in this manual. 1.2 Precautions for Installation the Product 1.2.1 Do not install in an unsafe place. 1.2.2 Do not install near inflammable objects or contaminated places. 1.2.3 Do not install in areas where moisture is high or exposed to direct sunlight, near heaters or near magnetic objects. 1.2.3 Make sure to use provided AC-DC adapter. 1.2.4 Plug the power cable to the grounded power outlet. Plugging to the ungrounded power outlet may cause device failure as well as electric shock. 1.2.5 Install the outlet in an easily accessible location. In event of technical issues, please disconnect the plug completely to turn off the power. 1.2.6 Do not drop or shock the product when moving. 1.2.7 Be careful as there is a biological risk of cross-infection. 1.3 Precautions before Use GenBody Inc. Page 8 / 28 1.3.1 This analyzer is designated to be used for in vitro diagnosis only. 1.3.2 Read this user manual and reagents manual thoroughly before use. 1.3.3 Please ensure to check the machine regularly for damage or contamination. 1.3.4 Use in well-ventilated and dry areas. 1.3.5 Check the battery percentage before use. If it’s insufficient, please charge the battery in advance. 1.4 Precautions during Use 1.4.1 Do not shock or move when analyzing. 1.4.2 Keep the machine level during analysis. 1.4.3 When installing the testing cartridge into the tray, make sure the cartridge is fully placed on the surface of the tray. 1.4.4 Press the operating button after the tray is c…

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GenBody Inc. 3-18, Eopseong 2-gil, Seobuk-gu, Cheonan-si, Chungcheongnam-do, South Korea Date: 04/21/2021 Timco Engineering, Inc. 849 N.W. State Road 45 P.O. Box 370 Newberry, Florida 32669 USA Letter of Authorization We, the undersigned, hereby authorize Geunki Son of DT&C Co., Ltd. to act on our behalf in all manners relating to application for equipment authorization for FCC ID: 2AZBMIAAF20 including signing of all documents relating to these matters. Any and all acts carried out by Geunki Son of DT&C Co., Ltd. on our behalf shall have the same affect as acts of our own. This authorization is valid until further written notice from GenBody Inc. “I, the undersigned, hereby certify that we are not subject to a denial of federal benefits, that includes FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. 853(a).” Sincerely, Name: Jinsoo Kim Position: CEO

GenBody Inc. 3-18, Eopseong 2-gil, Seobuk-gu, Cheonan-si, Chungcheongnam-do, South Korea Date: 04/21/2021 Timco Engineering, Inc. 849 N.W. State Road 45 P.O. Box 370 Newberry, Florida 32669 USA RE: Request of Confidentiality for FCC ID: 2AZBMIAAF20 To Whom It may Concern: Pursuant to Sections 0.457 and 0.459 of the Commission`s Rules(CFR 47), and Section 552 (b) (4) of the Freedom of Information Act, GenBody Inc. hereby requests confidentiality and treatment of certain information accompanying this application. The materials contain trade secrets and proprietary information not customarily released to the public. The public disclosure of these matters might be harmful to the Applicant and provide unjustified benefits to its competitors. We are also hereby request Short-Term Confidentiality for 180 days after the grant as outlined in Public Notice DA 04-1705. This provision will give GenBody Inc. temporary confidentiality of commercially sensitive information prior to product release. The requested permanent and Short-Term Confidential exhibits are listed as follows: PERMANENT & SHORT-TERM CONFIDENTIAL LIST Exhibit Description PERMANENT 1 Block Diagram 2 Schematics 3 Part Lists 4 Operation Description 5 NA SHORT-TERM 6 Internal Photos 7 External Photos 8 Test-Setup Photos 9 User Manual The Applicant understands that pursuant to Rule 0.457, disclosure of this application and all accompanying documentations, where applicable, will not be public before the date of the Grant for this application. Sincerely, Name: Jinsoo Kim Position: CEO

FCC ID: 2AZBMIAAF20 IC: 27104-IAAF20 Copyright Ⓒ 2021, DT&C Co., Ltd. View 1 FCC ID: 2AZBMIAAF20 IC: 27104-IAAF20 Copyright Ⓒ 2021, DT&C Co., Ltd. View 2 FCC ID: 2AZBMIAAF20 IC: 27104-IAAF20 Copyright Ⓒ 2021, DT&C Co., Ltd. View 3

FCC ID: 2AZBMIAAF20 Copyright Ⓒ 2021, DT&C Co., Ltd. SAMPLE LABEL & LOCATION LABELLING REQUIREMENTS The Label shown shall be permanently affixed at a conspicuous location on the device and be readily visible to the user at the time of purchase <Lobel location - Back side> <Sample Label> - The FCC label shown is representative of the label that will appear on the radio when in production. Other information may also be included on this label.

FCC ID: 2AZBMIAAF20 IC: 27104-IAAF20 Copyright Ⓒ 2021, DT&C Co., Ltd. View 1 FCC ID: 2AZBMIAAF20 IC: 27104-IAAF20 Copyright Ⓒ 2021, DT&C Co., Ltd. View 2 FCC ID: 2AZBMIAAF20 IC: 27104-IAAF20 Copyright Ⓒ 2021, DT&C Co., Ltd. View 3 <Antenna> FCC ID: 2AZBMIAAF20 IC: 27104-IAAF20 Copyright Ⓒ 2021, DT&C Co., Ltd. View 4

FCC ID: 2AZBMIAAF20 IC: 27104-IAAF20 Copyright Ⓒ 2021, DT&C Co., Ltd. View 5 FCC ID: 2AZBMIAAF20 IC: 27104-IAAF20 Copyright Ⓒ 2021, DT&C Co., Ltd. View 6 FCC ID: 2AZBMIAAF20 IC: 27104-IAAF20 Copyright Ⓒ 2021, DT&C Co., Ltd. View 7 FCC ID: 2AZBMIAAF20 IC: 27104-IAAF20 Copyright Ⓒ 2021, DT&C Co., Ltd. View 8 FCC ID: 2AZBMIAAF20 IC: 27104-IAAF20 Copyright Ⓒ 2021, DT&C Co., Ltd. View 9 <battery>

FCC ID: 2AZBMIAAF20 Report No.: DRTFCC2104-0034 IC: 27104-IAAF20 This test report is prohibited to copy or reissue in whole or in part without the approval of DT&C Co., Ltd. TRF-RF-203(09)210316 Pages: 2 / 20 Test Report Version Test Report No. Date Description Revised by Reviewed by DRTFCC2104-0034 Apr. 20, 2021 Initial issue SeungJu Woo JaeJin Lee FCC ID: 2AZBMIAAF20 Report No.: DRTFCC2104-0034 IC: 27104-IAAF20 This test report is prohibited to copy or reissue in whole or in part without the approval of DT&C Co., Ltd. TRF-RF-203(09)210316 Pages: 3 / 20 CONTENTS 1. General Information .................................................................. 4 1.1. Testing Laboratory ................................................................. 4 1.2. Testing Environment .............................................................. 4 1.3. Measurement Uncertainty ..................................................... 4 1.4. Details of Applicant ................................................................ 5 1.5. Description of EUT ................................................................ 5 1.6. Declaration by the applicant / manufacturer .......................... 5 2. Test Methodology ..................................................................... 6 2.1. EUT Configuration ................................................................. 6 2.2. EUT Exercise ........................................................................ 6 2.3. General Test Procedures ....................................................... 6 2.4. Description of Test Mode ....................................................... 6 2.5. Tested frequency ................................................................... 6 3. Antenna requirements .............................................................. 6 4. Test report ................................................................................. 7 4.1. Summary of tests .................................................................. 7 4.2. Transmitter requirements....................................................... 8 4.2.1. 20dB bandwidth & Occupied Bandwidth ........................... 8 4.2.2. In-band emissions ............................................................. 9 4.2.3. Out-of-band emissions ..................................................... 11 4.2.4. Frequency Stability .......................................................... 13 4.2.5. AC Power-Line Conducted Emissions ............................. 14 APPENDIX ................................................................................... 19 FCC ID: 2AZBMIAAF20 Report No.: DRTFCC2104-0034 IC: 27104-IAAF20 This test report is prohibited to copy or reissue in whole or in part without the approval of DT&C Co., Ltd. TRF-RF-203(09)210316 Pages: 4 / 20 1. General Information 1.1. Testing Laboratory DT&C Co., Ltd. The 3 m test site and conducted measurement facility used to collect the radiated data are located at the 42, Yurim-ro, 154beon-gil, Cheoin-gu, Yongin-si, Gyeonggi-do, Korea 17042. The test site complies with the requirements of § 2.948 according to ANSI C63.4-2014. - FCC & IC MRA Designation No. : KR0034 - ISED#: 5740A www.dtnc.net Telephone : + 82-31-321-2664 FAX : + 82-31-321-1664 1.2. Testing Environment Ambient Condition ▪ Temperature +22 °C ~ +24 °C ▪ Relative Humidity 39 % ~ 44 % 1.3. Measurement Uncertainty The measurement uncertainties shown below were calculated in accordance with requirements of ANSI C63.4- 2014 and ANSI C63.10-2013. All measurement uncertainty values are shown with a coverage factor of k = 2 to indicate a 95 % level of confidence. Parameter Measurement uncertainty AC power-line conducted emission 3.6 dB (The confidence level is about 95 %, k = 2) Radiated emission (Below 1 GHz) 4.9 dB (The confidence level is about 95 %, k = 2) FCC ID: 2AZBMIAAF20 Report No.: DRTFCC2104-0034 IC: 27104-IAAF20 This test report is prohibited to copy or reissue in whole or in part without the approval of DT&C Co., Ltd. TRF-RF-203(09)210316 Pages: 5 / 20 1.4. Details of Applicant Applicant Name(FCC) GenBody Inc. Applicant Name(IC) GenBody Inc. Address (FCC) 3-18, Eopseong 2-gil, Seobuk-gu, Cheonan-si, Chungcheongnam-do, South Korea Address (IC) 3-18, Eopseong 2-gil, Seobuk-gu Cheonan-si Chungcheongnam-do 31077 Korea (Republic Of) 1.5. Description of EUT Equipment Class Low Power Communications Device Transmitter (DXX) Product Name Fluorimetric Immunoassay Analyzer Model Name(FCC, IC) Confiscope F20 Add Model Name(FCC, IC) Confiscope F20V Firmware Version Identification Number RFID3021.001 EUT Serial Number Undesignated Power Supply DC 3.7 V Frequency Range 13.558 MHz Modulation Type ASK Antenna Type PCB Pattern Antenna 1.6. Declaration by the applicant / manufacturer N/A FCC ID: 2AZBMIAAF20 Report No.: DRTFCC2104-0034 IC: 27104-IAAF20 This test report is prohibited to copy or reissue in whole or in part without the approval of DT&C Co., Ltd. TRF-RF-203(09)210316 Pages: 6 / 20 2. Test Methodology The tests were performed according to the ANSI C63.10-2013. 2.1. EUT Configuration The EUT configuration for testing is installed on RF field strength measurement to meet the Commissions requirement and operating in a manner that intends to maximize its emission characteristics in a continuous normal application. 2.2. EUT Exercise The EUT was operated in the test mode to fix the TX frequency that was for the purpose of the measurements. According to its specifications, the EUT must comply with the requirements of the FCC and IC rules. 2.3. General Test Procedures Conducted Emissions According to the requirements in Section 6.2 of ANSI C63.10, the EUT is placed on the wooden table, which is 0.8 m above ground plane and the conducted emissions from the EUT are measured in the frequency range between 0.15 MHz and 30MHz using CISPR Quasi-peak and Average detector. Radiated Emissions The EUT is placed on a non-conductive table, which is 0.8 m above ground plane. The turnta…

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FCC ID: 2AZBMIAAF20 IC: 27104-IAAF20 Copyright Ⓒ 2021, DT&C Co., Ltd. Test Setup photographs EUT Position: X-axis EUT Position: Y-axis EUT Position: Z-axis FCC ID: 2AZBMIAAF20 IC: 27104-IAAF20 Copyright Ⓒ 2021, DT&C Co., Ltd. Test Setup Photo of Radiated Measurement (0.009 ~ 30MHz) FCC ID: 2AZBMIAAF20 IC: 27104-IAAF20 Copyright Ⓒ 2021, DT&C Co., Ltd. Test Setup Photo of Radiated Measurement (Below 1GHz) FCC ID: 2AZBMIAAF20 IC: 27104-IAAF20 Copyright Ⓒ 2021, DT&C Co., Ltd. Test Setup Photo of AC Line Conducted Measurement