2AT6UM5-FSBladder Scanner

Document No.: 1 / 90 Bladder Scanner Model:M5 User Manual Version: M5_V1.0.0.1 Suzhou PeakSonic Medical Technology Co.Ltd. Document No.: 2 / 90 Contents User Manual .................................................................................................................................................................. 1 Version: M5_V1.0.0.1 ................................................................................................................................................... 1 Contents ................................................................................................................................................................. 2 Chapter I Overview ....................................................................................................................................................... 1 1.1 Introduction ..................................................................................................................................................... 1 1.2 Intended Use .................................................................................................................................................... 2 1.3 Carry out Standards ......................................................................................................................................... 2 1.4 Service Life ...................................................................................................................................................... 4 1.5 Operating Environmental Requirement ........................................................................................................... 4 1.6 Statement on Electromagnetic Compatibility .................................................................................................. 5 1.7 Statement of the Manufacturer ........................................................................................................................ 6 1.8 Contraindications ............................................................................................................................................. 7 1.9 Release of the Heat Indexes and Mechanical Indexes ..................................................................................... 7 Chapter II Precautions ................................................................................................................................................... 1 2.1 Inspection before Operation............................................................................................................................. 1 2.2 Safety Check before Operation ........................................................................................................................ 1 2.3 Operating Instructions ..................................................................................................................................... 1 2.4 After Operation ................................................................................................................................................ 2 2.5 Situations to be Avoided .................................................................................................................................. 2 2.6 Cautions during Transportation ....................................................................................................................... 2 2.7 Relocate the Instrument ................................................................................................................................... 3 2.8 Malfunction ..................................................................................................................................................... 3 2.9 Regular Inspection and Maintenance of the Instrument .................................................................................. 3 2.10 Do not Disassemble the Instrument or Probe ................................................................................................ 3 2.11 Startup ............................................................................................................................................................ 3 Chapter III System Introduction .................................................................................................................................... 1 3.1 Appearance ...................................................................................................................................................... 1 3.2 Technical Specifications .................................................................................................................................. 2 3.3 Block Diagram ................................................................................................................................................. 4 3.4 Basic Principle ................................................................................................................................................. 4 3.5 Instrument Components ................................................................................................................................... 6 Chapter IV Installation .................................................................................................................................................. 1 4.1 Unpacking & Initial Inspection........................................................................................................................ 1 4.2 Installation and Disassemble .......................................................................................................................... 1 4.3 Power Supply ................................................................................................................................................... 3 4.3.1 Power Supply by AC ........................................................... 3 4.3.2 Power Supply by Battery ..........................…

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2021-02-07 Nemko Canada Inc 303 River Road Ottawa, Ontario, Canada K1V 1H2 Attn: Director of Certification Authority to Act as Agent On our behalf, I appoint Shenzhen Huatongwei International Inspection Co., Ltd./ 1/F, Bldg 3, Hongfa Hi-tech Industrial Park, Genyu Road, Tianliao, Gongming, Shenzhen, China / Hans Hu,. to act as our agent in the preparation of this application for equipment certification. I certify that submitted documents properly describe the device or system for which equipment certification is sought. I also certify that each unit manufactured, imported or marketed, as defined in the Federal Communications Commission’s regulations will have affixed to it a label identical to that submitted for approval with this application. For instances where our authorized agent signs the application for certification on our behalf, I acknowledge that all responsibility for complying with the terms and conditions for certification, as specified by Nemko Canada Inc, still resides with Suzhou PeakSonic Medical Technology Co.,LTD./ 2A,West Side of Building G4,Kunshan Hi-Tech Medical Device Industrial Park, Qiandeng Town, Kunshan City ,Suzhou City,Jiangsu Prov. Agency agreement expiration date: Feb. 06, 2022 By: Kevin Zhao Signature Printed Title: Finance Manager On behalf of : Suzhou PeakSonic Medical Technology Co.,LTD. Telephone: 17715168702

2021-02-07 Equipment Autorisation Division Federal Communications Commission 7435 Oakland Mills Road Columbia, MD 21046 FCC ID: 2AT6UM5-FS Product Name: Bladder Scanner Request for Confidentiality Pursuant to Sections 0.457 and 0.459 of the commissions rules, we hereby request that the following documents be held confidential:  Schematics  Block diagram  Operation description  BOM These materials contain trade secrets and proprietary information and are not customarily released to the public. The public disclosure of this information might be harmful to the company and provide unjustified benefits to our competitors. By: Kevin Zhao Signature Printed Title: Finance Manager On behalf of : Suzhou PeakSonic Medical Technology Co.,LTD. Telephone: 17715168702

7.EXTERANAL AND INTERNAL PHOTOS External photos of EUT Model:M5

Internal photos of EUT M odel:M5

Page: 1 of 17 TEST REPORT Report Reference No. .................... : CHTEW20120083 Report Verification: Project No.................................： SHT2008000202EW FCC ID ............................................. : 2AT6UM5-FS Applicant’s name ........................... : Suzhou PeakSonic Medical Technology Co.,LTD. Address ............................................. : 2A,West Side of Building G4,Kunshan Hi-Tech Medical Device Industrial Park, Qiandeng Town, Kunshan City ,Suzhou City, Jiangsu Prov. Manufacturer......................................: Suzhou Lischka Medtech Co., Ltd. Address...............................................: 2F,Building G4,Kunshan Hi-Tech Medical Device Industrial Park,No.999 Qu Jia Road,Qiandeng Town,Kunshan City,Jiangsu Prov. Test item description .................... : Bladder Scanner Trade Mark ....................................... : Model/Type reference ....................... : M5 Listed Model(s) ................................. : - Standard ......................................... : 47 CFR FCC Part 15 Subpart B Date of receipt of test sample...........: Dec. 06, 2020 Date of testing..............................: Dec. 07, 2020- Dec. 10, 2020 Date of issue.................................: Dec. 11, 2020 Result .................. ........................: Pass Compiled by ( position+printed name+signature) .. : File administrators Silvia Li Supervised by ( position+printed name+signature) .. : Project Engineer Xiao Cheng Approved by ( position+printed name+signature) .. : RF Manager Hans Hu Testing Laboratory Name ............. : Shenzhen Huatongwei International Inspection Co., Ltd. Address ............................................. : 1/F, Bldg 3, Hongfa Hi-tech Industrial Park, Genyu Road, Tianliao, Gongming, Shenzhen, China Shenzhen Huatongwei International Inspection Co., Ltd. All rights reserved. This publication may be reproduced in whole or in part for non-commercial purposes as long as the Shenzhen Huatongwei International Inspection Co., Ltd. is acknowledged as copyright owner and source of the material. Shenzhen Huatongwei International Inspection Co., Ltd. takes no responsibility for and will not assume liability for damages resulting from the reader's interpretation of the reproduced material due to its placement and context. The test report merely corresponds to the test sample. Report No : CHTEW20120083 Page 2 of 17 Issued: 2020-12-11 Shenzhen Huatongwei International Inspection Co., Ltd. Report Template Version: V01 (2018-01) Contents 1. TEST STANDARDS AND REPORT VERSION ........................................... 3 1.1. Test Standards 3 1.2. Report version information 3 2. TEST DESCRIPTION .................................................................... 4 3. SUMMARY ............................................................................... 5 3.1. Client Information 5 3.2. Product Description 5 3.3. EUT operation mode 5 4. TEST ENVIRONMENT ................................................................... 6 4.1. Address of the test laboratory 6 4.2. Test Facility 6 4.3. Environmental conditions 7 4.4. Statement of the measurement uncertainty 7 4.5. Equipments Used during the Test 8 5. TEST CONDITIONS AND RESULTS ..................................................... 9 5.1. Conducted Emissions Test 9 5.2. Radiated Emissions Test 12 6. TEST SETUP PHOTOS OF THE EUT .................................................. 16 7. EXTERNAL AND INTERNAL PHOTOS OF THE EUT .................................. 17 Report No : CHTEW20120083 Page 3 of 17 Issued: 2020-12-11 Shenzhen Huatongwei International Inspection Co., Ltd. Report Template Version: V01 (2018-01) 1. TEST STANDARDS AND REPORT VERSION 1.1. Test Standards The tests were performed according to following standards: 47 CFR FCC Part 15 Subpart B - Unintentional Radiators ANSI C63.4: 2014 – American National Standard for Methods of Measurement of Radio-Noise Emissions from Low-Voltage Electrical and Electronic Equipment in the Range of 9 kHz to 40GHz 1.2. Report version information Revision No. Date of issue Description N/A 2020-12-11 Original Report No : CHTEW20120083 Page 4 of 17 Issued: 2020-12-11 Shenzhen Huatongwei International Inspection Co., Ltd. Report Template Version: V01 (2018-01) 2. TEST DESCRIPTION Test Item Section in CFR 47 Result Test Engineer Conducted Emissions 15.107(a) PASS Jiongsheng Feng Radiated Emissions 15.109(a) PASS Jiongsheng Feng Note: The measurement uncertainty is not included in the test result. Report No : CHTEW20120083 Page 5 of 17 Issued: 2020-12-11 Shenzhen Huatongwei International Inspection Co., Ltd. Report Template Version: V01 (2018-01) 3. SUMMARY 3.1. Client Information Applicant: Suzhou PeakSonic Medical Technology Co.,LTD. Address: 2A,West Side of Building G4,Kunshan Hi-Tech Medical Device Industrial Park, Qiandeng Town, Kunshan City ,Suzhou City, Jiangsu Prov. Manufacturer: Suzhou Lischka Medtech Co., Ltd. Address: 2F,Building G4,Kunshan Hi-Tech Medical Device Industrial Park,No.999 Qu Jia Road,Qiandeng Town,Kunshan City,Jiangsu Prov. 3.2. Product Description Name of EUT: Bladder Scanner Trade Mark: Model No.: M5 Listed Model(s) - Power supply: DC 11.1V Adapter information: Model:FY1355000 Input: AC100-240V, 50/60Hz, 1.2A Output: 13.5Vdc, 5.0A 67.5W 3.3. EUT operation mode Test mode Describe Working mode Keep working Report No : CHTEW20120083 Page 6 of 17 Issued: 2020-12-11 Shenzhen Huatongwei International Inspection Co., Ltd. Report Template Version: V01 (2018-01) 4. TEST ENVIRONMENT 4.1. Address of the test laboratory Laboratory: Shenzhen Huatongwei International Inspection Co., Ltd. Address: 1/F, Bldg 3, Hongfa Hi-tech Industrial Park, Genyu Road, Tianliao, Gongming, Shenzhen, China Phone: 86-755-26748019 Fax: 86-755-26748089 4.2. Test Facility The test facility is recognized, certified, or accredited by the following organizations: CNAS-Lab Code: L1225 Shenzhen Huatongwei International Inspection Co., Ltd. has been assessed and…

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6.TEST SETUP PHOTOS OF THE EUT Conducted Emissions (AC Mains) Radiated Emissions (30MHz-1GHz) Radiated Emissions (Above 1GHz) Model:M5