2AS4N000003Ridge X-ray Flat Panel Detector

1 © InnoCare Optoelectronics Corporation │ X-Ray Products Ridge Series X-Ray Flat Panel Detector Operation Manual F14C InnoCare Optoelectronics Corp. 2 © InnoCare Optoelectronics Corporation │ X-Ray Products Radiologist or any other practitioners licensed should ensure that they have adequate knowledge of the operation prior using the Ridge 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 Ridge X-Ray Flat Panel Detector and cautions to be observed when operating it. After reading this manual, store it nearby the Ridge 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_2210_A1 Version: A1 Issued date: 2022/10/31 3 © InnoCare Optoelectronics Corporation │ 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 ............................................................... 7 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 ................................................................................... 9 1.9 Product Features ............................................................................................................... 10 1.10 Clinical Guide ................................................................................................................. 10 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 ........................................................................................................ 18 2.8 External Network Connection ............................................................................................... 18 2.9 System Isolation Instructions ............................................................................................... 19 2.10 Software Precautions .......................................................................................................... 20 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 ............................................................................................................... 28 2.16 Disposal of Waste ................................................................................................................ 30 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 Dimension (W x L x H) (mm) Weight 14 series Ridge F14C 460 x 383 x 15 2.8 Kg Ridge V14C 460 x 383 x 15 2.8 Kg Ridge F14G 460 x 383 x 15 3.0 Kg 17 series Ridge F17C 460 x 460 x 15 3.2 Kg Ridge V17C 460 x 460 x 15 3.0 Kg Ridge F17G 460 x 460 x 15 3.2 Kg

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 / 24 Project No: TM-2209000309P Rev.: 00 APPENDIX 1 - PHOTOGRAPHS OF EUT EXTERNAL PHOTOGRAPHS OF EUT Model: Ridge V14C, Ridge F14C, Ridge 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 / 24 Project No: TM-2209000309P 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 / 24 Project No: TM-2209000309P 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 / 24 Project No: TM-2209000309P 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 / 24 Project No: TM-2209000309P Rev.: 00 Model: Ridge F17C, Ridge V17C, Ridge F17G 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 / 24 Project No: TM-2209000309P 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 / 24 Project No: TM-2209000309P 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 / 24 Project No: TM-2209000309P 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 / 24 Project No: TM-2209000309P 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 / 24 Project No: TM-2209000309P Rev.: 00

30 © InnoCare Optoelectronics Corporation │ X-Ray Products 2.17 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 Ridge X-Ray Flat Panel Detector. 2.17.1 Identification Label Ridge F14C Ridge F14G 31 © InnoCare Optoelectronics Corporation │ X-Ray Products Ridge F17C Ridge F17G Ridge V14C 32 © InnoCare Optoelectronics Corporation │ X-Ray Products Ridge V17C 2.17.2 Battery Polarity Label 33 © InnoCare Optoelectronics Corporation │ X-Ray Products 2.17.3 Battery Label 2.17.4 Packing Carton Label 2.17.5 Adapter Specification Label 34 © InnoCare Optoelectronics Corporation │ X-Ray Products 2.17.6 DROC Label 2.17.7 Charger Label 2.17.8 Charger SN Label 35 © InnoCare Optoelectronics Corporation │ X-Ray Products 2.17.9 Adapter Specification Label (Charger) 2.17.10 Safety Symbols The following safety symbols are used in the labels or on its body. 36 © InnoCare Optoelectronics Corporation │ X-Ray Products

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 / 24 Project No: TM-2209000309P 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 / 24 Project No: TM-2209000309P 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 / 24 Project No: TM-2209000309P 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 / 24 Project No: TM-2209000309P 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 / 24 Project No: TM-2209000309P 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 / 24 Project No: TM-2209000309P 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 / 24 Project No: TM-2209000309P 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: 18 / 24 Project No: TM-2209000309P 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: 19 / 24 Project No: TM-2209000309P 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: 20 / 24 Project No: TM-2209000309P 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: 21 / 24 Project No: TM-2209000309P 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: 22 / 24 Project No: TM-2209000309P Rev.: 00 Module & Crystal NFC 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: 23 / 24 Project No: TM-2209000309P Rev.: 00 Antenna NFC Antenna 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: 24 / 24 Project No: TM-2209000309P Rev.: 00 Battery

INPAQ TECHNOLOGY CO., LTD 2020/09/02 UNLESS OTHER SPECIFIED TOLERANCES ON ： INPAQ TECHNOLOGY CO., LTD. X＝ ＝＝ ＝± ±± ± X . X＝ ＝＝ ＝± ±± ± X . X X＝ ＝＝ ＝ A N G L E S＝ ＝＝ ＝± ±± ± H O L E D I A＝ ＝＝ ＝± ±± ± SCALE： ：： ：N/A UNIT： ：： ：mm THIS DRAWINGS AND SPECIFICATIONS ARE THE PROPERTY OF INPAQ TECHNOLOGY CO.,LTD.AND SHALL NOT BE REPRODUCED OR USED AS THE BASIS FOR THE MANUFACTURE OR SALE OF APPARATUS OR DEVICES WITHOUT PERMISSION DRAWN BY： ：： ：涂正憲 涂正憲涂正憲 涂正憲 CHECKED BY： ：： ：鄭榮謀 鄭榮謀鄭榮謀 鄭榮謀 DESIGNED BY： ：： ：高嘉朋 高嘉朋高嘉朋 高嘉朋 APPROVED BY： ：： ：許博凱 許博凱許博凱 許博凱 TITLE： ：： ：NF-C-F9-R0-02-005 Specification DOCUMENT ENS000140800 SPEC REV. NO. P0 PAGE 1 OF 3 NF-C-F9-R0-02-005 Specification 1. Applications： ：： ： Near Filed Communication (NFC)、RFID 2. Explanation of Part Number： ：： ： (1) (2) (3) (4) (5) (6) (1) Product type：Near Field Communication (2) Material：PCB + Ferrite (3) Substrate：F9-Ferrite Type (4) Frequency ：R0-13.56MHz (RFID, HF Band) (5) Cable color：Black (6) Suffix：005 N F C F R 0 0 0 5 90 2 INPAQ TECHNOLOGY CO., LTD 2020/09/02 UNLESS OTHER SPECIFIED TOLERANCES ON ： INPAQ TECHNOLOGY CO., LTD. X＝ ＝＝ ＝± ±± ± X . X＝ ＝＝ ＝± ±± ± X . X X＝ ＝＝ ＝ A N G L E S＝ ＝＝ ＝± ±± ± H O L E D I A＝ ＝＝ ＝± ±± ± SCALE： ：： ：N/A UNIT： ：： ：mm THIS DRAWINGS AND SPECIFICATIONS ARE THE PROPERTY OF INPAQ TECHNOLOGY CO.,LTD.AND SHALL NOT BE REPRODUCED OR USED AS THE BASIS FOR THE MANUFACTURE OR SALE OF APPARATUS OR DEVICES WITHOUT PERMISSION DRAWN BY： ：： ：涂正憲 涂正憲涂正憲 涂正憲 CHECKED BY： ：： ：鄭榮謀 鄭榮謀鄭榮謀 鄭榮謀 DESIGNED BY： ：： ：高嘉朋 高嘉朋高嘉朋 高嘉朋 APPROVED BY： ：： ：許博凱 許博凱許博凱 許博凱 TITLE： ：： ：NF-C-F9-R0-02-005 Specification DOCUMENT ENS000140800 SPEC REV. NO. P0 PAGE 2 OF 3 3. Dimensions： ：： ： 外觀標準 需完整無破損，不可有變形、髒污、毛邊、 翹曲、裂縫、褶疊等情形。 工程圖上號為重點尺寸標註指示 工程圖上號為量測尺寸標註指示 只需量測重點尺寸 Drawing Rev.P4 Unit: mm INPAQ TECHNOLOGY CO., LTD 2020/09/02 UNLESS OTHER SPECIFIED TOLERANCES ON ： INPAQ TECHNOLOGY CO., LTD. X＝ ＝＝ ＝± ±± ± X . X＝ ＝＝ ＝± ±± ± X . X X＝ ＝＝ ＝ A N G L E S＝ ＝＝ ＝± ±± ± H O L E D I A＝ ＝＝ ＝± ±± ± SCALE： ：： ：N/A UNIT： ：： ：mm THIS DRAWINGS AND SPECIFICATIONS ARE THE PROPERTY OF INPAQ TECHNOLOGY CO.,LTD.AND SHALL NOT BE REPRODUCED OR USED AS THE BASIS FOR THE MANUFACTURE OR SALE OF APPARATUS OR DEVICES WITHOUT PERMISSION DRAWN BY： ：： ：涂正憲 涂正憲涂正憲 涂正憲 CHECKED BY： ：： ：鄭榮謀 鄭榮謀鄭榮謀 鄭榮謀 DESIGNED BY： ：： ：高嘉朋 高嘉朋高嘉朋 高嘉朋 APPROVED BY： ：： ：許博凱 許博凱許博凱 許博凱 TITLE： ：： ：NF-C-F9-R0-02-005 Specification DOCUMENT ENS000140800 SPEC REV. NO. P0 PAGE 3 OF 3 ITEM DESCRIPTION MATERIAL SPECIFICATION QUAN- TITY UNIT 1 PCB (NPG-151)(Surface block) L50*W40*T0.8mm 1 PCS 2 Cable Φ1.13, Black 1 PCS 3 Tube Shrink Tube,EVA,OD3.0*20mm 1 PCS 4 Connector I-PEX MHF Connector I-PEX Equivalent(compatible) 1 PCS 5 Adhesive 3M-8010 1 PCS 6 Ferrite L49.7*W39.7*T0.08mm 1 PCS

Project No: TM-2209000309P FCC ID: 2AS4N000003 Page: 1 / 29 Report No.: TMWK2209003824KR 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 FCC 47 CFR PART 15 SUBPART C TEST REPORT For Ridge X-ray Flat Panel Detector Model No.: Ridge F17C, Ridge V14C, Ridge V17C, Ridge F14C, Ridge F14G, Ridge F17G Trade Name: INCX Issued to InnoCare Optoelectronics Corp Rm. B, No. 2, Sec. 2, Huanxi Rd., Southern Taiwan Science Park, Xinshi Dist., Tainan, 741 Taiwan Issued by Compliance Certification Services Inc. Wugu Laboratory No.11, Wugong 6th Rd., Wugu Dist., New Taipei City, Taiwan. Issued Date: November 30, 2022 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 / 29 Report No.: TMWK2209003824KR Rev.: 00 Revision History Rev. Issue Date Revisions Effect Page Revised By 00 November 30, 2022 Initial Issue ALL 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 / 29 Report No.: TMWK2209003824KR Rev.: 00 TABLE OF CONTENTS 1. TEST RESULT CERTIFICATION ....................................................................................4 2. EUT DESCRIPTION ........................................................................................................5 3. TEST METHODOLOGY ..................................................................................................6 3.1 EUT CONFIGURATION ..........................................................................................6 3.2 FCC PART 15.205 RESTRICTED BANDS OF OPERATIONS .................................6 3.3 DESCRIPTION OF TEST MODES ..........................................................................7 4. TEST SUMMARY ............................................................................................................8 5. INSTRUMENT CALIBRATION ........................................................................................9 5.1 MEASURING INSTRUMENT CALIBRATION ..........................................................9 5.2 MEASUREMENT EQUIPMENT USED ....................................................................9 5.3 MEASUREMENT UNCERTAINTY ........................................................................ 10 5.4 FACILITIES AND TEST LOCATION ...................................................................... 10 6. SETUP OF EQUIPMENT UNDER TEST ....................................................................... 11 6.1 SETUP CONFIGURATION OF EUT ...................................................................... 11 6.2 SUPPORT EQUIPMENT ....................................................................................... 11 7. FCC PART 15.225 REQUIREMENTS ........................................................................... 12 7.1 OCCUPIED BANDWIDTH(99%) AND 20 DB BANDWIDTH ................................... 12 7.2 FUNDAMENTAL AND RADIATED EMISSIONS .................................................... 14 7.3 FREQUENCY STABILITY ..................................................................................... 23 7.4 POWERLINE CONDUCTED EMISSIONS ............................................................. 27 APPENDIX A PHOTOGRAPHS OF TEST SETUP ........................................................... A-1 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 / 29 Report No.: TMWK2209003824KR Rev.: 00 1. TEST RESULT CERTIFICATION Applicant: InnoCare Optoelectronics Corp Rm. B, No. 2, Sec. 2, Huanxi Rd., Southern Taiwan Science Park, Xinshi Dist., Tainan, 741 Taiwan Manufacturer: InnoCare Optoelectronics Corp Rm. B, No. 2, Sec. 2, Huanxi Rd., Southern Taiwan Science Park, Xinshi Dist., Tainan City 741, Taiwan, R.O.C. Equipment Under Test: Ridge X-ray Flat Panel Detector Trade Name: INCX Model No.: Ridge F17C, Ridge V14C, Ridge V17C, Ridge F14C, Ridge F14G, Ridge F17G Date of Test: October 7 ~ 17, 2022 APPLICABLE STANDARDS STANDARD TEST RESULT FCC 47 CFR Part 15 Subpart C Compliance Statements of Conformity Determination of compliance is based on the results of the compliance measurement, not taking into account measurement instrumentation uncertainty. We hereby certify that: The above equipment was tested by Compliance Certification Services Inc. The test data, data evaluation, test procedures, and equipment configurations shown in this report were made in accordance with the procedures given in ANSI C63.10: 2013 an…

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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: A-1 / A-4 Report No.: TMWK2209003824KR Rev.: 00 APPENDIX A PHOTOGRAPHS OF TEST SETUP CONDUCTED EMISSION SETUP PHOTOS 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: A-2 / A-4 Report No.: TMWK2209003824KR Rev.: 00 Radiated Emission Set up Photos 9kHz ~ 30MHz 30MHz ~ 1GHz 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: A-3 / A-4 Report No.: TMWK2209003824KR Rev.: 00 Conduction 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: A-4 / A-4 Report No.: TMWK2209003824KR Rev.: 00