2AS4N000002Yushan X-ray Flat Panel Detector

1 © InnoCare Optoelectronics CorporaƟon │ X‐Ray Products Yushan Series X‐Ray Flat Panel Detector 玉山X光平板偵檢器(F14C, F14G) Operation Manual InnoCare Optoelectronics Corp. 2 © InnoCare Optoelectronics CorporaƟon │ X‐Ray Products Radiologist or any other practitioners licensed should ensure that they have adequate knowledge of the operation prior using the Yushan X‐Ray Flat Panel Detector. This Operation Manual should be studied and understood before proceeding to operate the equipment on patients; it describes details on how to operate the Yushan X ‐Ray Flat Panel Detector and cautions to be observed when operating it. After reading this manual, store it nearby the Yushan X‐Ray Flat Panel Detector so that you can see it whenever necessary. "Caution: Federal Law restricts this device to sale by or on the order of a radiologist or any other practitioners licensed by the law of the state in which that person practices to use or order the use of the device." _________________________________________________________________________________ Caution This Operation Manual contains confidential and proprietary information of the Manufacturer. Before using the device, please check local regulations. If any local legislation is violated, use cannot be authorized. If additional training or material for training is needed, please directly contact our official dealer or InnoCare Representative. _________________________________________________________________________________ Trademarks Company names described in this manual are the trademarks or registered trademarks of InnoCare Optoelectronics Corp. or their respective holders. Windows is the registered trademark of US Microsoft Corporation in the U.S.A. and other countries. Copyright © 2019 InnoCare Optoelectronics Corporation. All rights reserved. Document Number: INCX_YS_F_OM_ENG_2211_A4 Version: A4 Issued date: 2022/11/25 Phone: +886‐6‐7007238 Website: https://www.innocare‐x.com/ 3 © InnoCare Optoelectronics CorporaƟon │ X‐Ray Products Table of Content Chapter 1 Introduction ........................................................................................................................ 6 1.1 Product Introduction ......................................................................................................... 7 1.2 Product Series .................................................................................................................... 7 1.3 Product Intended Use ........................................................................................................ 7 1.4 Product Significant Performance Characteristics .............................................................. 8 1.5 Product Intended Patient Population ................................................................................ 8 1.6 Product Intended Part of the body or type of tissue applied to or interacted with ......... 9 1.7 Product Intended user profile ........................................................................................... 9 1.8 Product Intended conditions of use ................................................................................ 10 1.9 Product Features .............................................................................................................. 10 1.10 Clinical Guide ................................................................................................................ 11 Chapter 2 Safety and Regulatory ....................................................................................................... 11 2.1 Compliance Standards and Classification ............................................................................ 11 2.1.1 Compliance Standards .............................................................................................. 11 2.1.2 Classification ............................................................................................................. 12 2.2 Contraindications ................................................................................................................. 12 2.3 Power Supply Hazard ........................................................................................................... 13 2.4 Electric Shock Hazard ........................................................................................................... 13 2.5 Abnormalities Hazard .......................................................................................................... 15 2.6 Installation Precautions ....................................................................................................... 15 2.7 Connection Instructions ....................................................................................................... 17 2.8 External Network Connection .............................................................................................. 17 2.9 System Isolation Instructions............................................................................................... 18 2.10 Software Precautions ......................................................................................................... 19 2.11 Disinfection Instructions .................................................................................................... 19 2.12 Charging the Battery Pack .................................................................................................. 20 2.13 Battery Pack Instructions ................................................................................................... 21 2.14 Warnings for Pediatric Use ................................................................................................ 26 2.15 Other Precautions .............................................................................................................. 27 2.16 Disposal of Waste .............................................................................................................. 28 2.17 Product Labels ...…

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1 © InnoCare Optoelectronics CorporaƟon │ X‐Ray Products Yushan Series X‐Ray Flat Panel Detector 玉山X光平板偵檢器 (V14C, V14G, V17C, V17G) Operation Manual InnoCare Optoelectronics Corp. 2 © InnoCare Optoelectronics CorporaƟon │ X‐Ray Products Radiologist or any other practitioners licensed should ensure that they have adequate knowledge of the operation prior using the Yushan X‐Ray Flat Panel Detector. This Operation Manual should be studied and understood before proceeding to operate the equipment on patients; it describes details on how to operate the Yushan X ‐Ray Flat Panel Detector and cautions to be observed when operating it. After reading this manual, store it nearby the Yushan X‐Ray Flat Panel Detector so that you can see it whenever necessary. "Caution: Federal Law restricts this device to sale by or on the order of a radiologist or any other practitioners licensed by the law of the state in which that person practices to use or order the use of the device." _________________________________________________________________________________ Caution This Operation Manual contains confidential and proprietary information of the Manufacturer. Before using the device, please check local regulations. If any local legislation is violated, use cannot be authorized. If additional training or material for training is needed, please directly contact our official dealer or InnoCare Representative. _________________________________________________________________________________ Trademarks Company names described in this manual are the trademarks or registered trademarks of InnoCare Optoelectronics Corp. or their respective holders. Windows is the registered trademark of US Microsoft Corporation in the U.S.A. and other countries. Copyright © 2019 InnoCare Optoelectronics Corporation. All rights reserved. Document Number: INCX_YS_V_OM_ENG_2211_A13 Version: A13 Issued date: 2022/11/25 Phone: +886‐6‐7007238 Website: https://www.innocare‐x.com/ 3 © InnoCare Optoelectronics CorporaƟon │ X‐Ray Products Table of Content Chapter 1 Introduction ....................................................................................................................... 6 1.1 Product Introduction ........................................................................................................ 7 1.2 Product Series ................................................................................................................... 7 1.3 Product Intended Use ....................................................................................................... 7 1.4 Product Significant Performance Characteristics ............................................................. 8 1.5 Product Intended Patient Population .............................................................................. 9 1.6 Product Intended Part of the body or type of tissue applied to or interacted with ........ 9 1.7 Product Intended user profile .......................................................................................... 9 1.8 Product Intended conditions of use ............................................................................... 10 1.9 Product Features ............................................................................................................ 11 1.10 Clinical Guide .............................................................................................................. 11 Chapter 2 Safety and Regulatory ...................................................................................................... 12 2.1 Compliance Standards and Classification........................................................................... 12 2.1.1 Compliance Standards ............................................................................................. 12 2.1.2 Classification ............................................................................................................ 13 2.2 Contraindications ............................................................................................................... 13 2.3 Power Supply Hazard ......................................................................................................... 13 2.4 Electric Shock Hazard.......................................................................................................... 14 2.5 Abnormalities Hazard ......................................................................................................... 16 2.6 Installation Precautions ...................................................................................................... 16 2.7 Connection Instructions ..................................................................................................... 17 2.8 External Network Connection ............................................................................................ 18 2.9 System Isolation Instructions ............................................................................................. 19 2.10 Software Precautions ....................................................................................................... 19 2.11 Disinfection Instructions .................................................................................................. 20 2.12 Charging the Battery Pack ................................................................................................ 21 2.13 Battery Pack Instructions ................................................................................................. 22 2.14 Warnings for Pediatric Use ............................................................................................... 27 2.15 Other Precautions............................................................................................................. 27 2.16 Disposal of Waste ............................................................................................................. 29 2.17 Product Labels ................................…

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Model difference: The only difference is the size of the peripheral Board as marked red colunm in the following figure, 14 series has 14 ROIC, 17 series has 17 ROIC, the rest main PCBA are the same. The following figure is for 17 series with 17 ROIC. Product Model name Width Length (mm) Height (mm) Weight (Kg) 14 series V14C 460 383 15 2.7 V14G 460 383 15 2.7 F14C 460 383 15 2.5 F14G 460 383 15 2.3 17 series V17C 460 460 15 3.2 V17G 460 460 15 3.2

This document cannot be reproduced except in full, without prior written approval of the Company. 本報告未經本公司書面許可，不可部份複製。 Page: 1 / 19 Project No: TM-2211000034P Rev.: 00 APPENDIX 1 - PHOTOGRAPHS OF EUT EXTERNAL PHOTOGRAPHS OF EUT Model: V14C, V14G, F14C, F14G This document cannot be reproduced except in full, without prior written approval of the Company. 本報告未經本公司書面許可，不可部份複製。 Page: 2 / 19 Project No: TM-2211000034P Rev.: 00 This document cannot be reproduced except in full, without prior written approval of the Company. 本報告未經本公司書面許可，不可部份複製。 Page: 3 / 19 Project No: TM-2211000034P Rev.: 00 This document cannot be reproduced except in full, without prior written approval of the Company. 本報告未經本公司書面許可，不可部份複製。 Page: 4 / 19 Project No: TM-2211000034P Rev.: 00 This document cannot be reproduced except in full, without prior written approval of the Company. 本報告未經本公司書面許可，不可部份複製。 Page: 5 / 19 Project No: TM-2211000034P Rev.: 00 Model: V17C, V17G This document cannot be reproduced except in full, without prior written approval of the Company. 本報告未經本公司書面許可，不可部份複製。 Page: 6 / 19 Project No: TM-2211000034P Rev.: 00 This document cannot be reproduced except in full, without prior written approval of the Company. 本報告未經本公司書面許可，不可部份複製。 Page: 7 / 19 Project No: TM-2211000034P Rev.: 00 This document cannot be reproduced except in full, without prior written approval of the Company. 本報告未經本公司書面許可，不可部份複製。 Page: 8 / 19 Project No: TM-2211000034P Rev.: 00 This document cannot be reproduced except in full, without prior written approval of the Company. 本報告未經本公司書面許可，不可部份複製。 Page: 9 / 19 Project No: TM-2211000034P Rev.: 00 Adapter (Mean well / GSM60A24-P1L) This document cannot be reproduced except in full, without prior written approval of the Company. 本報告未經本公司書面許可，不可部份複製。 Page: 10 / 19 Project No: TM-2211000034P Rev.: 00

Product Labels The information of each label can be found in this section and the corresponding location are also presented as the following figure. The following labels are adhered to the Yushan X-Ray Flat Panel Detector. Drawing Yushan V14/F14 series Yushan V17 series

2022/12/22 update Yushan series rating label FCC ID: 2AS4N000002 XXXXXXXXXXXXXX FCC ID: 2AS4N000002 XXXXXXXXXXXXXX

This document cannot be reproduced except in full, without prior written approval of the Company. 本報告未經本公司書面許可，不可部份複製。 Page: 11 / 19 Project No: TM-2211000034P Rev.: 00 INTERNAL PHOTOGRAPHS OF EUT This document cannot be reproduced except in full, without prior written approval of the Company. 本報告未經本公司書面許可，不可部份複製。 Page: 12 / 19 Project No: TM-2211000034P Rev.: 00 This document cannot be reproduced except in full, without prior written approval of the Company. 本報告未經本公司書面許可，不可部份複製。 Page: 13 / 19 Project No: TM-2211000034P Rev.: 00 This document cannot be reproduced except in full, without prior written approval of the Company. 本報告未經本公司書面許可，不可部份複製。 Page: 14 / 19 Project No: TM-2211000034P Rev.: 00 This document cannot be reproduced except in full, without prior written approval of the Company. 本報告未經本公司書面許可，不可部份複製。 Page: 15 / 19 Project No: TM-2211000034P Rev.: 00 This document cannot be reproduced except in full, without prior written approval of the Company. 本報告未經本公司書面許可，不可部份複製。 Page: 16 / 19 Project No: TM-2211000034P Rev.: 00 This document cannot be reproduced except in full, without prior written approval of the Company. 本報告未經本公司書面許可，不可部份複製。 Page: 17 / 19 Project No: TM-2211000034P Rev.: 00 Module & Crystal This document cannot be reproduced except in full, without prior written approval of the Company. 本報告未經本公司書面許可，不可部份複製。 Page: 18 / 19 Project No: TM-2211000034P Rev.: 00 Antenna TAOGLAS / PC143.54.0360A TAOGLAS / PC143.54.0470A This document cannot be reproduced except in full, without prior written approval of the Company. 本報告未經本公司書面許可，不可部份複製。 Page: 19 / 19 Project No: TM-2211000034P Rev.: 00 Battery SIMPLO / X221AW2-B0G

Project No: TM-2211000034P FCC ID: 2AS4N000002 Page: 1 / 33 Report No.: TMWK2211004436KS Rev.: 00 No.11, Wugong 6th Rd., Wugu Dist., New Taipei City , Taiwan /新北市五股區五工六路11號 t:(886-2) 2299-9720 f:(886-2) 2299-9721 www.sgs.com.tw Unless otherwise stated the results shown in this test report refer only to the sample(s) tested and such sample(s) are retained for 90 days only. 除非另有說明，此報告結果僅對測試之樣品負責，同時此樣品僅保留90天。本報告未經本公司書面許可，不可部份複製。 This document is issued by the Company subject to its General Conditions of Service printed overleaf, available on request or accessible at http://www.sgs.com.tw/Terms-and-Conditions and, for electronic format documents, subject to Terms and Conditions for Electronic Documents at http://www.sgs.com.tw/Terms-and-Conditions. Attention is drawn to the limitation of liability, indemnification and jurisdiction issues defined therein. Any holder of this document is advised that information contained hereon reflects the Company’s findings at the time of its intervention only and within the limits of client’s instruction, if any. The Company’s sole responsibility is to its Client and this document does not exonerate parties to a transaction from exercising all their rights and obligations under the transaction documents. This document cannot be reproduced, except in full, without prior written approval of the Company. Any unauthorized alteration, forgery or falsification of the content or appearance of this document is unlawful and offenders may be prosecuted to the fullest extent of the law. Compliance Certification Services Inc. 程智科技股份有限公司 Member of the SGS Group SAR TEST REPORT FCC 47 CFR § 2.1093 IEEE Std 1528-2013 for Yushan X-ray Flat Panel Detector Model Name.: V14C, V14G, F14C, F14G Prepared for: InnoCare Optoelectronics Corp. Rm. B, No. 2, Sec. 2, Huanxi Rd., Southern Taiwan Science Park, Xinshi Dist., Tainan, 741 Taiwan Prepared by Compliance Certification Services Inc. Wugu Lab. No.11, Wugong 6th Rd., Wugu Dist., New Taipei City, Taiwan. Issue Date: December 29, 2022 Note: This document may be altered or revised by Compliance Certification Services Inc. personnel only, and shall be noted in the revision section of the document. The client should not use it to claim product endorsement by TAF, A2LA, NIST or any government agencies. The test results in the report only apply to the tested sample. This document cannot be reproduced except in full, without prior written approval of the Company. 本報告未經本公司書面許可，不可部份複製。 Page 2 / 33 Report No.: TMWK2211004436KS Rev. 00 Revision History Rev. Issue Date Revisions Revised By 00 December 29, 2022 Initial Issue Doris Chu This document cannot be reproduced except in full, without prior written approval of the Company. 本報告未經本公司書面許可，不可部份複製。 Page 3 / 33 Report No.: TMWK2211004436KS Rev. 00 Table of Contents 1 ATTESTATION OF TEST RESULTS ................................................................... 4 2 TEST SPECIFICATION, METHODS AND PROCEDURES .................................. 5 3 DEVICE UNDER TEST (DUT) INFORMATION .................................................... 6 3.1 DUT DESCRIPTION .............................................................................................................. 6 3.2 WIRELESS TECHNOLOGIES ............................................................................................... 7 4 SAR MEASUREMENT SYSTEM .......................................................................... 8 4.1 SYSTEM COMPONENTS ..................................................................................................... 9 4.2 SAR SCAN PROCEDURES ................................................................................................ 12 5 MEASUREMENT UNCERTAINTY ..................................................................... 14 6 RF EXPOSURE CONDITIONS (TEST CONFIGURATIONS) ............................. 15 6.1 STANDALONE SAR TEST EXCLUSION CONSIDERATIONS .......................................... 15 6.2 REQUIRED TEST CONFIGURATIONS .............................................................................. 17 7 DIELECTRIC PROPERTY MEASUREMENTS & SYSTEM CHECK .................. 18 7.1 DIELECTRIC PROPERTY MEASUREMENTS ................................................................... 18 7.2 SYSTEM CHECK ................................................................................................................. 21 8 CONDUCTED OUTPUT POWER MEASUREMENTS ........................................ 23 8.1 WI-FI 2.4GHZ (DTS BAND) ................................................................................................. 23 8.2 WI-FI 5GHZ (U-NII BANDS) ................................................................................................ 24 9 MEASURED AND REPORTED (SCALED) SAR RESULTS ............................. 26 9.1 WI-FI (DTS BAND) ............................................................................................................... 26 9.2 WI-FI (U-NII BAND) ............................................................................................................. 26 10 SAR MEASUREMENT VARIABILITY ................................................................ 27 11 SIMULTANEOUS TRANSMISSION SAR ANALYSIS ........................................ 28 11.1 SUM OF THE SAR FOR WI-FI ............................................................................................ 31 12 EQUIPMENT LIST & CALIBRATION STATUS .................................................. 32 13 FACILITIES ......................................................................................................... 33 14 APPENDIXES ..................................................................................................... 33 This document cannot be reproduced except in full, without prior written approval of the Company. 本報告未經本公司書面許可，不可部份複製。 Page 4 / 33 Report No.: TMWK2211004436KS Rev. 00 1 Attestation of Test Results Applicant Name InnoCare Optoelectronics Corp. Model Name V14C, V14…

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Project No: TM-2211000034P FCC ID: 2AS4N000002 Page: 1 / 33 Report No.: TMWK2211004437KS Rev.: 00 No.11, Wugong 6th Rd., Wugu Dist., New Taipei City , Taiwan /新北市五股區五工六路11號 t:(886-2) 2299-9720 f:(886-2) 2299-9721 www.sgs.com.tw Unless otherwise stated the results shown in this test report refer only to the sample(s) tested and such sample(s) are retained for 90 days only. 除非另有說明，此報告結果僅對測試之樣品負責，同時此樣品僅保留90天。本報告未經本公司書面許可，不可部份複製。 This document is issued by the Company subject to its General Conditions of Service printed overleaf, available on request or accessible at http://www.sgs.com.tw/Terms-and-Conditions and, for electronic format documents, subject to Terms and Conditions for Electronic Documents at http://www.sgs.com.tw/Terms-and-Conditions. Attention is drawn to the limitation of liability, indemnification and jurisdiction issues defined therein. Any holder of this document is advised that information contained hereon reflects the Company’s findings at the time of its intervention only and within the limits of client’s instruction, if any. The Company’s sole responsibility is to its Client and this document does not exonerate parties to a transaction from exercising all their rights and obligations under the transaction documents. This document cannot be reproduced, except in full, without prior written approval of the Company. Any unauthorized alteration, forgery or falsification of the content or appearance of this document is unlawful and offenders may be prosecuted to the fullest extent of the law. Compliance Certification Services Inc. 程智科技股份有限公司 Member of the SGS Group SAR TEST REPORT FCC 47 CFR § 2.1093 IEEE Std 1528-2013 for Yushan X-ray Flat Panel Detector Model Name.: V17C, V17G Prepared for: InnoCare Optoelectronics Corp. Rm. B, No. 2, Sec. 2, Huanxi Rd., Southern Taiwan Science Park, Xinshi Dist., Tainan, 741 Taiwan Prepared by Compliance Certification Services Inc. Wugu Lab. No.11, Wugong 6th Rd., Wugu Dist., New Taipei City, Taiwan. Issue Date: December 29, 2022 Note: This document may be altered or revised by Compliance Certification Services Inc. personnel only, and shall be noted in the revision section of the document. The client should not use it to claim product endorsement by TAF, A2LA, NIST or any government agencies. The test results in the report only apply to the tested sample. This document cannot be reproduced except in full, without prior written approval of the Company. 本報告未經本公司書面許可，不可部份複製。 Page 2 / 33 Report No.: TMWK2211004437KS Rev. 00 Revision History Rev. Issue Date Revisions Revised By 00 December 29, 2022 Initial Issue Doris Chu This document cannot be reproduced except in full, without prior written approval of the Company. 本報告未經本公司書面許可，不可部份複製。 Page 3 / 33 Report No.: TMWK2211004437KS Rev. 00 Table of Contents 1 ATTESTATION OF TEST RESULTS ................................................................... 4 2 TEST SPECIFICATION, METHODS AND PROCEDURES .................................. 5 3 DEVICE UNDER TEST (DUT) INFORMATION .................................................... 6 3.1 DUT DESCRIPTION .............................................................................................................. 6 3.2 WIRELESS TECHNOLOGIES ............................................................................................... 7 4 SAR MEASUREMENT SYSTEM .......................................................................... 8 4.1 SYSTEM COMPONENTS ..................................................................................................... 9 4.2 SAR SCAN PROCEDURES ................................................................................................ 12 5 MEASUREMENT UNCERTAINTY ..................................................................... 14 6 RF EXPOSURE CONDITIONS (TEST CONFIGURATIONS) ............................. 15 6.1 STANDALONE SAR TEST EXCLUSION CONSIDERATIONS .......................................... 15 6.2 REQUIRED TEST CONFIGURATIONS .............................................................................. 17 7 DIELECTRIC PROPERTY MEASUREMENTS & SYSTEM CHECK .................. 18 7.1 DIELECTRIC PROPERTY MEASUREMENTS ................................................................... 18 7.2 SYSTEM CHECK ................................................................................................................. 21 8 CONDUCTED OUTPUT POWER MEASUREMENTS ........................................ 23 8.1 WI-FI 2.4GHZ (DTS BAND) ................................................................................................. 23 8.2 WI-FI 5GHZ (U-NII BANDS) ................................................................................................ 24 9 MEASURED AND REPORTED (SCALED) SAR RESULTS ............................. 26 9.1 WI-FI (DTS BAND) ............................................................................................................... 26 9.2 WI-FI (U-NII BAND) ............................................................................................................. 26 10 SAR MEASUREMENT VARIABILITY ................................................................ 27 10.1 WI-FI (U-NII BAND) ............................................................................................................. 27 11 SIMULTANEOUS TRANSMISSION SAR ANALYSIS ........................................ 28 11.1 SUM OF THE SAR FOR WI-FI ............................................................................................ 31 12 EQUIPMENT LIST & CALIBRATION STATUS .................................................. 32 13 FACILITIES ......................................................................................................... 33 14 APPENDIXES ..................................................................................................... 33 This document cannot be reproduced except in full, without prior written approval of the Company. 本報告未經本公司書面許可，不可部份複製。 Page 4 / 33 Report N…

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Test Laboratory: CCS Taiwan.(R.O.C),Ltd. Wugu Laboratory. Date: 2022/11/26 System Performance Check-D2450V2-727 Frequency: 2450 MHz; Duty Cycle: 1:1; Room Ambient Temperature: 22.1C; Liquid Temperature: 22.4C Medium parameters used: f = 2450 MHz; σ = 1.794 S/m; ε r = 40.307; ρ = 1000 kg/m 3 DASY5 Configuration: - Area Scan Setting: Find Secondary Maximum Within: 2.0 dB and with a peak SAR value greater than 0.0012W/kg - Electronics: DAE4 Sn877; Calibrated: 2022/4/28 - Probe: EX3DV4 - SN3665; ConvF(7.28, 7.28, 7.28) @ 2450 MHz; Calibrated: 2022/8/28 - Sensor-Surface: 2mm (Mechanical Surface Detection) - Phantom: ELI Head/Pin=250mW/Area Scan (81x81x1): Interpolated grid: dx=1.200 mm, dy=1.200 mm Maximum value of SAR (interpolated) = 21.3 W/kg Head/Pin=250mW/Zoom Scan (7x7x7)/Cube 0: Measurement grid: dx=5mm, dy=5mm, dz=5mm Reference Value = 109.9 V/m; Power Drift = 0.06 dB Peak SAR (extrapolated) = 29.0 W/kg SAR(1 g) = 14 W/kg; SAR(10 g) = 6.49 W/kg Smallest distance from peaks to all points 3 dB below = 9 mm Ratio of SAR at M2 to SAR at M1 = 48.6% Maximum value of SAR (measured) = 21.4 W/kg 0 dB = 21.4 W/kg = 13.30 dBW/kg Test Laboratory: CCS Taiwan.(R.O.C),Ltd. Wugu Laboratory. Date: 2022/11/25 System Performance Check-D5GHzV2-1023-5750 Frequency: 5750 MHz; Duty Cycle: 1:1; Room Ambient Temperature: 22.3C; Liquid Temperature: 22.7C Medium parameters used: f = 5750 MHz; σ = 5.309 S/m; ε r = 35.922; ρ = 1000 kg/m 3 DASY5 Configuration: - Area Scan Setting: Find Secondary Maximum Within: 2.0 dB and with a peak SAR value greater than 0.0012W/kg - Electronics: DAE4 Sn877; Calibrated: 2022/4/28 - Probe: EX3DV4 - SN3665; ConvF(5.04, 5.04, 5.04) @ 5750 MHz; Calibrat…

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