SMQSE301EDANElectrocardiograph

I About this Manual P/N: 01.54.456718 MPN: 01.54.456718011 Release Date: July, 2015 © Copyright EDAN INSTRUMENTS, INC. 2015. All rights reserved. Statement This manual will help you understand the operation and maintenance of the product better. It is reminded that the product shall be used strictly complying with this manual. User’s operation failing to comply with this manual may result in malfunction or accident for which EDAN INSTRUMENTS, INC. (hereinafter called EDAN) can not be held liable. EDAN owns the copyrights of this manual. Without prior written consent of EDAN, any materials contained in this manual shall not be photocopied, reproduced or translated into other languages. Materials protected by the copyright law, including but not limited to confidential information such as technical information and patent information are contained in this manual, the user shall not disclose such information to any irrelevant third party. The user shall understand that nothing in this manual grants him, expressly or implicitly, any right or license to use any of the intellectual properties of EDAN. EDAN holds the rights to modify, update, and ultimately explain this manual. Product Information Product Name: Electrocardiograph Model: SE-301, iSE-301 Responsibility of the Manufacturer EDAN only considers itself responsible for any effect on safety, reliability and performance of the equipment if: Assembly operations, extensions, re-adjustments, modifications or repairs are carried out by persons authorized by EDAN, and II The electrical installation of the relevant room complies with national standards, and The instrument is used in accordance with the instructions for use. Upon request, EDAN may provide, with compensation, necessary circuit diagrams, and other information to help qualified technician to maintain and repair some parts, which EDAN may define as user serviceable. Terms Used in this Manual This guide is designed to give key concepts on safety precautions. WARNING A WARNING label advises against certain actions or situations that could result in personal injury or death. CAUTION A CAUTION label advises against actions or situations that could damage equipment, produce inaccurate data, or invalidate a procedure. NOTE A NOTE provides useful information regarding a function or a procedure. III Table of Contents Chapter 1 Safety Guidance ....................................................................................................... 1 1.1 Indications for Use/Intended Use ..................................................................................... 1 1.2 Warnings and Cautions ..................................................................................................... 1 1.2.1 Safety Warnings ........................................................................................................ 2 1.2.2 Lithium Battery Care Warnings ................................................................................ 5 1.2.3 General Cautions ...................................................................................................... 6 1.3 List of Symbols ................................................................................................................. 7 Chapter 2 Introduction ............................................................................................................ 10 2.1 Top Panel ........................................................................................................................ 10 2.2 Bottom Panel ................................................................................................................... 11 2.3 Right Panel ...................................................................................................................... 11 2.4 Back Panel ...................................................................................................................... 11 Chapter 3 Operation Preparations ......................................................................................... 12 3.1 Loading/Replacing Recorder Paper ................................................................................ 12 3.2 Preparing the Patient ....................................................................................................... 13 3.2.1 Instructing the Patient ............................................................................................. 13 3.2.2 Cleaning the Skin .................................................................................................... 13 3.3 Connecting the Patient Cable to the Electrocardiograph and Electrodes ....................... 13 3.4 Attaching Electrodes to the Patient ................................................................................. 14 3.4.1 Reusable Electrodes ................................................................................................ 14 3.4.2 Disposable Electrodes ............................................................................................. 17 3.5 Inspection Before Power On ........................................................................................... 18 Chapter 4 Sampling and Printing ECG ................................................................................. 20 4.1 Entering Patient Information .......................................................................................... 20 4.1.1 Entering Patient Information Manually .................................................................. 20 4.1.2 Entering Patient Information by Acquiring Orders ................................................ 21 4.2 Printing ECG Reports ..................................................................................................... 21 4.3 Sample ECG Reports ...................................................................................................... 22 4.3.1 ECG Reports in the AUTO Mode ...........................................................…

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Model Difference Declaration To: TUV SUD BABT TCB Octagon House Concorde Way Segensworth North Fareham Hamp shire PO15 5RL United Kingdom For our business issue and marketing requirement, we would like to list series model number on the Type Certification and reports, as following: Model No.: iSE-301 List Mode: SE-301 We (EDAN INSTRUMENTS,INC.; Address: 3/F-B, Nanshan Medical Equipment Park, Nanhai Rd 1019#, Shekou, Nanshan Shenzhen, 518067 P.R. CHINA ) declare that all models have the same PCB Layout, circuit theory, construction , critical components and backlight except the model name. Please kindly handle on the project. Thank you! Signature: Name / Title: Xiahuanhuan Company Name: EDAN INSTRUMENTS,INC. Address: 3/F-B,Nanshan Medical Equipment Park,Nanhai Rd 1019#,Shekou,Nanshan Shenzhen,518067 P.R. CHINA TEL: +86-0755-26682507 FAX: +86-0755-26898326 E-Mail: [email protected]

Date (20/07/2015) TUV SUD BABT TCB Octagon House, Segensworth Road, Fareham, Hampshire, PO15 5RL Dear Sir or Madam, We, (EDAN INSTRUMENTS,INC.; Address: 3/F-B, Nanshan Medical Equipment Park, Nanhai Rd 1019#, Shekou, Nanshan Shenzhen, 518067 P.R. CHINA), hereby authorize (John Zhi [TÜV SÜD Certification and Testing (China) Co., Ltd. Shenzhen Branch; Address: Building 12&13, Zhiheng Wisdomland Business Park, Nantou Checkpoint Road 2, Nanshan District, Shenzhen City, 518052, P. R. China Tel. +86 755 8828 6998, Fax: +86 755 8828 5299) to act as our agent in all matters relating to applications for equipment authorization, including the signing of all documents relating to these matters. Type of equipment: Electrocardiograph Model name: SE-301, iSE-301 FCC ID: SMQSE301EDAN This authorization expires on 2016-01-20 Sincerely, Company Officer: EDAN INSTRUMENTS,INC. Telephone Number: 0755-26682547 Email: [email protected]

2015-07-20 TUV SUD BABT TCB Octagon House, Segensworth Road, Fareham, Hampshire, PO15 5RL Confidentiality Request FCC ID: SMQSE301EDAN Pursuant to Sections 0.457(d)(1)(ii) and 0.459 of the Commission’s Rules, (EDAN INSTRUMENTS,INC.) hereby requests permanent confidential treatment of information accompanying this application as outlined below: Schematics Block Diagrams Theory of Operation] (EDAN INSTRUMENTS,INC.) also hereby requests short-term confidential treatment of information accompanying this application as outlined below for a period of (180) days: Internal Photos External Photos User Manual Test Set-up Photographs The above 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. The Applicant understands that pursuant to Rule 0.457(d)(1)(ii), disclosure of this Application and all accompanying materials will not be made before the date of the Grant for this Application. Yours sincerely, Company Officer: Xiahuanhuan Telephone Number: 0755-26682547 Email: [email protected]

APPENDIX B – External of EUT Page 1 of 5 TÜV SÜD Certification and Testing (China) Co., Ltd. Shenzhen Branch Building12&13, Zhiheng Wisdomland Business Park, Nantou Checkpoint Road 2, Shenzhen, China, 518052 APPENDIX B – External of EUT Page 2 of 5 TÜV SÜD Certification and Testing (China) Co., Ltd. Shenzhen Branch Building12&13, Zhiheng Wisdomland Business Park, Nantou Checkpoint Road 2, Shenzhen, China, 518052 APPENDIX B – External of EUT Page 3 of 5 TÜV SÜD Certification and Testing (China) Co., Ltd. Shenzhen Branch Building12&13, Zhiheng Wisdomland Business Park, Nantou Checkpoint Road 2, Shenzhen, China, 518052 APPENDIX B – External of EUT Page 4 of 5 TÜV SÜD Certification and Testing (China) Co., Ltd. Shenzhen Branch Building12&13, Zhiheng Wisdomland Business Park, Nantou Checkpoint Road 2, Shenzhen, China, 518052 Battery View: APPENDIX B – External of EUT Page 5 of 5 TÜV SÜD Certification and Testing (China) Co., Ltd. Shenzhen Branch Building12&13, Zhiheng Wisdomland Business Park, Nantou Checkpoint Road 2, Shenzhen, China, 518052 Adapter View:

APPENDIX C – Internal of EUT Page 1 of 9 TÜV SÜD Certification and Testing (China) Co., Ltd. Shenzhen Branch Building12&13, Zhiheng Wisdomland Business Park, Nantou Checkpoint Road 2, Shenzhen, China, 518052 WIFI Antenna APPENDIX C – Internal of EUT Page 2 of 9 TÜV SÜD Certification and Testing (China) Co., Ltd. Shenzhen Branch Building12&13, Zhiheng Wisdomland Business Park, Nantou Checkpoint Road 2, Shenzhen, China, 518052 APPENDIX C – Internal of EUT Page 3 of 9 TÜV SÜD Certification and Testing (China) Co., Ltd. Shenzhen Branch Building12&13, Zhiheng Wisdomland Business Park, Nantou Checkpoint Road 2, Shenzhen, China, 518052 Antenna Connector APPENDIX C – Internal of EUT Page 4 of 9 TÜV SÜD Certification and Testing (China) Co., Ltd. Shenzhen Branch Building12&13, Zhiheng Wisdomland Business Park, Nantou Checkpoint Road 2, Shenzhen, China, 518052 APPENDIX C – Internal of EUT Page 5 of 9 TÜV SÜD Certification and Testing (China) Co., Ltd. Shenzhen Branch Building12&13, Zhiheng Wisdomland Business Park, Nantou Checkpoint Road 2, Shenzhen, China, 518052 APPENDIX C – Internal of EUT Page 6 of 9 TÜV SÜD Certification and Testing (China) Co., Ltd. Shenzhen Branch Building12&13, Zhiheng Wisdomland Business Park, Nantou Checkpoint Road 2, Shenzhen, China, 518052 APPENDIX C – Internal of EUT Page 7 of 9 TÜV SÜD Certification and Testing (China) Co., Ltd. Shenzhen Branch Building12&13, Zhiheng Wisdomland Business Park, Nantou Checkpoint Road 2, Shenzhen, China, 518052 APPENDIX C – Internal of EUT Page 8 of 9 TÜV SÜD Certification and Testing (China) Co., Ltd. Shenzhen Branch Building12&13, Zhiheng Wisdomland Business Park, Nantou Checkpoint Road 2, Shenzhen, China, 518052 Adapter: APPENDIX C – Internal of EUT Page 9 of 9 TÜV SÜD Certification and Testing (China) Co., Ltd. Shenzhen Branch Building12&13, Zhiheng Wisdomland Business Park, Nantou Checkpoint Road 2, Shenzhen, China, 518052

TÜV SÜD Certification and Testing (China) Co., Ltd. Shenzhen Branch Building 12&13, Zhiheng Wisdomland Business Park, Nantou Checkpoint Road 2, Nanshan District, Shenzhen City, 518052, P. R. China RF exposure Estimation for iSE-301 1. Introduction EUT is a Electrocardiograph, which contain WIFI function inside. 2. Limit and Guidelines on Exposure to Electromagnetic Fields According to§15.247(e)(i) and §1.1307(b)(1), systems operating under the provisions of this section shall be operated in a manner that ensure that the public is not exposed to radio frequency energy level in excess of the Commission’s guideline. According to KDB 447498 D01 Mobile Portable RF Exposure v05r02, no SAR required if power is lower than the flowing threshold: The 1-g and 10-g SAR test exclusion thresholds for 100 MHz to 6 GHz at test separation distances ≤ 50 mm are determined by: [(max. power of channel, including tune-up tolerance, mW)/(min. test separation distance, mm)] [√f(GHz)] ≤ 3.0 for 1-g SAR and ≤ 7.5 for 10-g extremity SAR, where • f(GHz) is the RF channel transmit frequency in GHz • Power and distance are rounded to the nearest mW and mm before calculation25 • The result is rounded to one decimal place for comparison • 3.0 and 7.5 are referred to as the numeric thresholds in the step 2 below The test exclusions are applicable only when the minimum test separation distance is ≤ 50 mm and for transmission frequencies between 100 MHz and 6 GHz. When the minimum test separation distance is < 5 mm, a distance of 5 mm according to 5) in section 4.1 is applied to determine SAR test exclusion. 3. Calculation method [(max. power of` channel, including tune-up tolerance, mW)/(min. test separation distance, mm)] ·[√f(GHz)] ≤ 3.0 Conducted Power + tune up tolerance = 9.33mW (9.7dBm) Distance = 5 mm f = 2.480 GHz TÜV SÜD Certification and Testing (China) Co., Ltd. Shenzhen Branch Building 12&13, Zhiheng Wisdomland Business Park, Nantou Checkpoint Road 2, Nanshan District, Shenzhen City, 518052, P. R. China [9.33/5] * SQRT(2.412) =2.90 2.90 ≤ 3.0 Therefore, excluded from SAR testing. TÜV SÜD Certification and Testing (China) Co., Ltd. Shenzhen Branch Reviewed by: Prepared By: John Zhi/ EMC Project Manager Alan Xiong/EMC Project Engineer Date: 2015-07-27 Date: 2015-07-27

Report Number: 68.930.15.011.01 EMC_SZ_FR_21.00 FCC Release 2014-03-20 TÜV SÜD Certification and Testing (China) Co., Ltd. Shenzhen Branch Building 12&13, Zhiheng Wisdomland Business Park, Nantou Checkpoint Road 2, Nanshan District, Shenzhen City, 518052, P. R. China Tel. +86 755 8828 6998, Fax: +86 755 8828 5299 Page 1 of 40 FCC - TEST REPORT Report Number : 68.930.15.011.01 Date of Issue: July 10, 2015 Model : SE-301, iSE-301 Product Type : Electrocardiograph Applicant : EDAN INSTRUMENTS,INC. Address : 3/F-B, Nanshan Medical Equipment Park, Nanhai Rd 1019#, Shekou, Nanshan Shenzhen, 518067 P.R. CHINA Production Facility : EDAN INSTRUMENTS,INC. Address : 3/F-B, Nanshan Medical Equipment Park, Nanhai Rd 1019#, Shekou, Nanshan Shenzhen, 518067 P.R. CHINA Test Result :  Positive  Negative Total pages including Appendices : 40 TÜV SÜD Certification and Testing (China) Co., Ltd. Shenzhen Branch is a subcontractor to TÜV SÜD Product Service GmbH according to the principles outlined in ISO 17025. TÜV SÜD Certification and Testing (China) Co., Ltd. Shenzhen Branch reports apply only to the specific samples tested under stated test conditions. Construction of the actual test samples has been documented. It is the manufacturer's responsibility to assure that additional production units of this model are manufactured with identical electrical and mechanical components. The manufacturer/importer is responsible to the Competent Authorities in Europe for any modifications made to the production units which result in non-compliance to the relevant regulations. TÜV SÜD Certification and Testing (China) Co., Ltd. Shenzhen Branch shall have no liability for any deductions, inferences or generalizations drawn by the client or others from TÜV SÜD Certification and Testing (China) Co., Ltd. Shenzhen Branch issued reports. This report is the confidential property of the client. As a mutual protection to our clients, the public and ourselves, extracts from the test report shall not be reproduced except in full without our written approval Report Number: 68.930.15.011.01 EMC_SZ_FR_21.00 FCC Release 2014-03-20 TÜV SÜD Certification and Testing (China) Co., Ltd. Shenzhen Branch Building 12&13, Zhiheng Wisdomland Business Park, Nantou Checkpoint Road 2, Nanshan District, Shenzhen City, 518052, P. R. China Tel. +86 755 8828 6998, Fax: +86 755 8828 5299 Page 2 of 40 1 Table of Contents 1 Table of Contents .................................................................................................................. 2 2 Details about the Test Laboratory ......................................................................................... 3 3 Description of the Equipment Under Test .............................................................................. 4 4 Summary of Test Standards .................................................................................................. 5 5 Summary of Test Results ...................................................................................................... 6 6 General Remarks .................................................................................................................. 7 7 Test Setups ........................................................................................................................... 8 8 Systems test configuration .................................................................................................... 9 9 Technical Requirement ....................................................................................................... 10 9.1 Conducted Emission ..................................................................................................... 10 9.2 Conducted peak output power ...................................................................................... 13 9.3 6dB bandwidth .............................................................................................................. 15 9.4 Power spectral density .................................................................................................. 21 9.5 Spurious RF conducted emissions ............................................................................... 22 9.6 Band edge testing ......................................................................................................... 32 9.7 Spurious radiated emissions for transmitter .................................................................. 36 10 Test Equipment List ............................................................................................................ 39 11 System Measurement Uncertainty ...................................................................................... 40 Report Number: 68.930.15.011.01 EMC_SZ_FR_21.00 FCC Release 2014-03-20 TÜV SÜD Certification and Testing (China) Co., Ltd. Shenzhen Branch Building 12&13, Zhiheng Wisdomland Business Park, Nantou Checkpoint Road 2, Nanshan District, Shenzhen City, 518052, P. R. China Tel. +86 755 8828 6998, Fax: +86 755 8828 5299 Page 3 of 40 2 Details about the Test Laboratory Details about the Test Laboratory Test Site 1 Company name: TÜV SÜD Certification and Testing (China) Co., Ltd. Shenzhen Branch Building 12&13, Zhiheng Wisdomland Business Park, Nantou Checkpoint Road 2, Nanshan District, Shenzhen City, 518052, P. R. China FCC Registration Number: 502708 Telephone: 86 755 8828 6998 Fax: 86 755 8828 5299 Report Number: 68.930.15.011.01 EMC_SZ_FR_21.00 FCC Release 2014-03-20 TÜV SÜD Certification and Testing (China) Co., Ltd. Shenzhen Branch Building 12&13, Zhiheng Wisdomland Business Park, Nantou Checkpoint Road 2, Nanshan District, Shenzhen City, 518052, P. R. China Tel. +86 755 8828 6998, Fax: +86 755 8828 5299 Page 4 of 40 3 Description of the Equipment Under Test Product: Electrocardiograph Model no.: SE-301, iSE-301 FCC ID: SMQSE301EDAN Brand Name: EDAN Options and accessories: NIL Rating: Input: AC 100-240V~50/60Hz, 1.1A (Adapter) DC 19.0V, Max 2.53A (Electr…

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APPENDIX A – Photos of Test Setup Page 1 of 2 TÜV SÜD Certification and Testing (China) Co., Ltd. Shenzhen Branch Building12&13, Zhiheng Wisdomland Business Park, Nantou Checkpoint Road 2, Shenzhen, China, 518052 Radio Emission (30MHz-1GHz) Radio Emission (Above 1GHz) APPENDIX A – Photos of Test Setup Page 2 of 2 TÜV SÜD Certification and Testing (China) Co., Ltd. Shenzhen Branch Building12&13, Zhiheng Wisdomland Business Park, Nantou Checkpoint Road 2, Shenzhen, China, 518052 Conducted Emission