2AZC7FA5001Quantitative Immunoassay Analyzer

Intellectual Property © 2004-2021 Genrui Biotech Inc. All rights reserved. Genrui Biotech Inc. (hereinafter called Genrui) owns the intellectual property rights to this product and this manual. Without prior written consent of Genrui, any person or entity is strictly forbidden to use, disclose or allow others to obtain any information in this manual by any means, and any materials contained in this manual shall not be photocopied, reproduced or translated into other languages. Genrui reserves the right to modify and update this manual without prior notice. Genrui reserves the right of final interpretation for this manual. , are registered trademarks of Genrui. Statement Genrui shall be liable for product safety, reliability and performance provided that the following requirements are met: 1）All installation operations, expansions, changes, modifications and repairs of this product are conducted by Genrui authorized personnel. 2）All replaceable parts involved in maintenance as well as the related accessories and comsumables are original or approved by Genrui. 3）Any associated electrical equipment complies with national standards and the requirements of this manual. 4）Use and operation of this product are performed in strict accordance with this manual. Warranty Genrui warrants that Genrui’ products meet the labeled specifications of the products and will be free from defects in materials and workmanship that occur within warranty period. The warranty is void in cases of: ◼Damage caused by accidents. ◼Damage caused by mishandling during shipping. ◼Malfunction or damage caused by force majeure such as fire and earthquake. ◼Malfunction or damage caused by unstable or out-of-range power input. ◼Malfunction or damage caused by improper operation or repair by unauthorized service people. ◼Malfunction of the analyzer whose serial number is not legible enough. ◼Others not caused by instrument itself. If a product covered by this warranty is determined to be defective because of defective materials, components or workmanship, and the warranty claim is made within the warranty period, Genrui will, at its discretion, repair or replace the defective part(s) free of charge. Customer Service Department Manufacturer: Genrui Biotech Inc. Address: 4-10F, Building 3, Geya Technology Park, Guangming District, 518106, Shenzhen, China Website URL: www.genrui-bio.com E-mail Address: [email protected] Tel: +86 755 26835560 Fax: +86 755 26678789 ⚫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. Changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment. 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. ⚫This analyzer can only be operated by test professionals, doctors or laboratory technicians who have been trained by Genrui or its distributors. ⚫It is important for the hospital or organization that employs this equipment to carry out a reasonable service/maintenance plan. Neglect of this may result in machine breakdown or injury of human health. ⚫Be sure to operate the analyzer under the situation specified in this manual; otherwise, the analyzer will not work normally and the test results will be unreliable, which would damage the analyzer components and cause personal injury. This operation manual is written for the following laboratory professionals: 1.Daily system operator. 2.Personnel for system maintenance and troubleshooting. 3.Learners for system operation. Commented [G1]: Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. FA50 Operation Manual i Introduction We would like to sincerely thank you for choosing to purchase Genrui product. Please read this manual carefully in order to ensure correct use of the product. After carefully reading this manual, please keep it safely stored so that you can refer to it when necessary. Product Name: Quantitative Immunoassay Analyzer Model: FA50 Product Composition: The analyzer is mainly composed of the host, which includes microprocessor, detection system, LCD screen and printer. Scope of Product Application: The analyzer is used to quantitatively test human samples with particular dry reagents, which are based on the immunofluorescence technique. Manufacturer: Genrui Biotech Inc. Registered Address: 4-10F, Building 3, Geya Technology Park, Guangming District, 518106, Shenzhen, China Error! Use the Home tab to apply 标题 1 to the text that you want to appear here. ii FA50 Operation Manual Date of Manufacture: See the nameplate of the instrument Manual Preparation Date: August 22, 2019 Manual Revision Date: January 7, 2021 Item No.: P01.91.300417-02 FCC ID：2AZC7FA5001 51000001 Commented [G2]: Error! Use the Home tab to ap…

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SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch Page: 1 of 5 External Photos for SZEM2012012742CR FCC ID: 2AZC7FA5001 SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch Page: 2 of 5 1 EUT Constructional Details SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch Page: 3 of 5 SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch Page: 4 of 5 SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch Page: 5 of 5

SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch Page: 1 of 11 Internal Photos for SZEM2012012742CR FCC ID: 2AZC7FA5001 SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch Page: 2 of 11 1 EUT Constructional Details SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch Page: 3 of 11 SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch Page: 4 of 11 SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch Page: 5 of 11 SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch Page: 6 of 11 SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch Page: 7 of 11 SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch Page: 8 of 11 NFC Antenna SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch Page: 9 of 11 SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch Page: 10 of 11 SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch Page: 11 of 11

SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch Report No.: SZEM201201274202 Page: 1 of 29 Keny Xu EMC Laboratory Manager TEST REPORT Application No.: SZEM2012012742CR Applicant: Genrui Biotech Inc. Address of Applicant: 4-10F, Building 3, Geya Technology Park, Guangming District, 518106, Shenzhen, China Manufacturer: Genrui Biotech Inc. Address of Manufacturer: 4-10F, Building 3, Geya Technology Park, Guangming District, 518106, Shenzhen, China Factory: Genrui Biotech Inc. Address of Factory: 4-10F, Building 3, Geya Technology Park, Guangming District, 518106, Shenzhen, China Equipment Under Test (EUT): EUT Name: Quantitative Immunoassay Analyzer Model No.: FA50, VF10   Please refer to section 2 of this report which indicates which model was actually tested and which were electrically identical. Trade Mark: GENRUI FCC ID: 2AZC7FA5001 Standard(s) : 47 CFR Part 15, Subpart C 15.225 Date of Receipt: 2020-12-10 Date of Test: 2020-12-11 to 2021-01-04 Date of Issue: 2021-01-05 Test Result: Pass* * In the configuration tested, the EUT complied with the standards specified above. SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch Report No.: SZEM201201274202 Page: 2 of 29 Revision Record Version Chapter Date Modifier Remark 01 2021-01-05 Original Authorized for issue by: Damon Su/Project Engineer Eric Fu/Reviewer SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch Report No.: SZEM201201274202 Page: 3 of 29 2 Test Summary Radio Spectrum Technical Requirement Item Standard Method Requirement Result Antenna Requirement 47 CFR Part 15, Subpart C 15.225 N/A 47 CFR Part 15, Subpart C 15.203 Pass Radio Spectrum Matter Part Item Standard Method Requirement Result 20dB Bandwidth 47 CFR Part 15, Subpart C 15.225 15.225 ANSI C63.10 (2013) Section 6.9 47 CFR Part 15, Subpart C 15.215 Pass Conducted Emissions at Mains Terminals (150kHz-30MHz) 47 CFR Part 15, Subpart C 15.225 15.225 ANSI C63.10 (2013) Section 6.2 47 CFR Part 15, Subpart C 15.207 Pass Emission Mask 47 CFR Part 15, Subpart C 15.225 15.225 ANSI C63.10 (2013) Section 6.4 47 CFR Part 15, Subpart C 15.225(a)&(b)&(C ) Pass Frequency tolerance 47 CFR Part 15, Subpart C 15.225 15.225 ANSI C63.10 (2013) Section 6.8 47 CFR Part 15, Subpart C 15.225(e) Pass Radiated Emissions (30MHz-1GHz) 47 CFR Part 15, Subpart C 15.225 15.225 ANSI C63.10 (2013) Section 6.5 47 CFR Part 15, Subpart C 15.225(d) & 15.209 Pass Radiated Emissions (9kHz-30MHz) 47 CFR Part 15, Subpart C 15.225 15.225 ANSI C63.10 (2013) Section 6.4 47 CFR Part 15, Subpart C 15.225(d) & 15.209 Pass Remark: Model No.: FA50, VF10 Only the model FA50 was tested, since according to the declaration from the applicant, the electrical circuit design, layout, components used, internal wiring and functions were identical for all the above models, with only difference on appearance color. SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch Report No.: SZEM201201274202 Page: 4 of 29 3 Contents Page 1 COVER PAGE ............................................................................................................................................ 1 2 TEST SUMMARY ....................................................................................................................................... 3 3 CONTENTS ................................................................................................................................................ 4 4 GENERAL INFORMATION ........................................................................................................................ 6 4.1 DETAILS OF E.U.T. ............................................................................................................................... 6 4.2 DESCRIPTION OF SUPPORT UNITS ......................................................................................................... 6 4.3 MEASUREMENT UNCERTAINTY .............................................................................................................. 6 4.4 TEST LOCATION .................................................................................................................................... 7 4.5 TEST FACILITY ...................................................................................................................................... 7 4.6 DEVIATION FROM STANDARDS ............................................................................................................... 7 4.7 ABNORMALITIES FROM STANDARD CONDITIONS ..................................................................................... 7 5 EQUIPMENT LIST ...................................................................................................................................... 8 6 RADIO SPECTRUM MATTER TEST RESULTS ..................................................................................... 10 6.1 20DB BANDWIDTH .............................................................................................................................. 10 6.1.1 E.U.T. Operation .......................................................................................................................... 10 6.1.2 Test Mode Description ................................................................................................................. 10 6.1.3 Test Setup Diagram ..................................................................................................................... 10 6.1.4 Measurement Procedure and Data............................................................................................. 10 6.2 CONDUCTED EMISSIONS AT MAINS TERMINALS (150KHZ-30MHZ) ........................................................ 12 6.2.1 E.U.T. Operation .......................................................................................................................... 12 6.2.2 Test Mode Description ......................................................................................…

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SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch Page: 1 of 3 Setup Photos for SZEM2012012742CR FCC ID: 2AZC7FA5001 SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch Page: 2 of 3 1 Photographs Conducted Emissions at Mains Terminals (150kHz-30MHz) SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch Page: 3 of 3 Radiated Emissions (30MHz-1GHz) Radiated Emissions (9kHz-30MHz)