RP4WECARDIOUN01ECG Event Recorder

1 ECG EVENT RECORDER User’s Manual for recorder TO USE THE ECG EVENT RECORDER You will need: > A Smartphone or an iPad(with Bluetooth & Wifi/Data on) > The ECG Event recorder > The AIRCardio APP <Note: the smart phone shall support Bluetooth 4.0, Android 4.3+ or IOS> Contact us: BORSAM Biomedical Instruments Co.,Ltd Call: +86 0755 86325336 Fax: +86 0755 86325336 Emial: [email protected] www.bioxtime.com 2 Copyright Declaration: Copyright © BORSAM Biomedical Instruments Co., Ltd. All rights reserved. iPhone, iPad, iPod, iOS and the Apple logo are either registered trademarks or trademarks of Apple Corporation in the United States and/or other countries. BORSAM Biomedical Instruments Co., Ltd., BORSAM logo, and WECARDIO logo and ECG Web Center are trademarks orregistered trademarks of BORSAM Biomedical Instruments Co., Ltd. All other brand names and product names used in this document are trade names, service marks, trademarks or registered trademarks of their respective owners. The information and screens provided in this manual are subject to change without notice. BORSAM Biomedical Instruments Co., Ltd. SHALL NOT BE LIABLE FOR TECHNICAL OR EDITORIAL ERRORS OR OMISSIONS CONTAINED HEREIN; NOR FOR INCIDENTAL OR CONSEQUENTIAL DAMAGES RESULTING FROM THE FURNISHING,PERFORMANCE, OR USE OF THIS MATERIAL. Authorized Representatives: CHINA BORSAM Biomedical Instruments Co., Ltd. Rm. 502, University Innovation PARK Lishan road Xili Town 518055 Shenzhen 86-755-8632 5336 Declaration of Conformity: Conformance to Standards – non-clinical testing demonstrated conformance to voluntary safety IEC60601-1 and to IEC60601-1-2-2014 Class IIa. Warning: Changes or modifications to this unit not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment. NOTE: 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: 3  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 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. BORSAM Biomedical Instruments Co., Ltd.’s Quality System conforms to21 CFR 820 and ISO13485:2012 Danger : Equipment not suitable for use in the presence of flammable anesthetic mixture with air or with Oxygen or Nitrous Oxide. Contraindications: There are no potential adverse effects of the ECG-Event Recorder on health. Description: This guide describes the ECG Event Recorder to use, and related cleaning and maintenance operations. The metal sheets on the side and front is the position of application part. Patients can safely use the ECG signal collection function of the device; The device does not have unsafe functions. Classification: Class II / Internally powered equipment; Type BF applied part; IP22; Continuous operation mode 4 TABLE OF CONTENTS COPYRIGHT DECLARATION ........................................ 2 DECLARATION OF CONFORMITY ................................ 2 DANGER ......................................................................... 3 CONTRAINDICATIONS .................................................. 3 DESCRIPTION ................................................................ 3 CLASSIFICATION ........................................................... 3 OVERVIEW ........................................... ...5 INTENDED USE .............................................................. 5 ACCESSORIES ............................................................... 5 SPECIFICATIONS ........................................................... 5 OPERATING CONDITIONS ............................................ 5 STORAGE AND SHIPPING ............................................ 5 TO GET STARTED .................................. 6 DOWNLISD APP ............................................................. 6 USER LOG IN ................................................................. 6 BULETOOTH PARTING YOUR DEVICE ........................ 6 ARRHYTHMIA CHECK ................................................... 7 ST CHECK ...................................................................... 8 HRV/ANS Check ........................................................... 10 Recording List .............................................................. 10 SETTING ....................................................................... 11 NOTICE ......................................................................... 11 WHO SHOULD USE THE DEVICE ............................... 11 WARNING ..................................................................... 11 REGULATORY COMPLIANCE..................................... 12 MAINTENANCE ..................................... 12 BATTERY ...................................................................... 12 CARING FOR YOUR ECG EVENT RECORDER .......... 12 ENVIRONMENT .....................................................…

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BORSAM Biomedical Instruments Co.,Ltd. Office of Engineering Technology Federal Communications Commission 7435 Oakland Mills Road Columbia, MD 21046 Date: 2020/5/25 Subject; Request for Confidentiality FCC ID: RP4WECARDIOUN01 To Whom It May Concern, Pursuant to the provisions of the Commission’s rules Title 47 Sections §0.457 and §0.459, we are requesting the Commission to withhold the following attachment(s) as confidential documents from public disclosure indefinitely. These documents contain detailed system and equipment descriptions and are considered as proprietary information in operation of the equipment. The public disclosure of these documents might be harmful to our company and would give competitors an unfair advantage in the market. Schematic Diagram Block Diagram Operational Description In additional to above mentioned documents, in order to comply with the marketing regulations in Title 47 CFR §2.803 and the importation rules in Title 47 CFR §2.1204, while ensuring that business sensitive information remains confidential until the actual marketing of newly authorized devices, we request Short Term Confidentiality of the following attachment(s); External Photos Test Setup Photos Internal Photos User Manual For 45 days, pursuant to Public Notice DA 04-1705. OR For 180 days pursuant to KDB 726920 D01. It is our understanding that all measurement test reports, FCC ID label format and correspondence during the certification review process cannot be granted as confidential documents and this information will be available for public review once the grant of equipment authorization is issued. Sincerely, Signature: Name: DingHong Mao Title: Certification Manager

. Letter of Authorization Company: BORSAM Biomedical Instruments Co.,Ltd. Address: Rm. 502, University Innovation PARK Lishan road Xi, Shenzhen, China Product Name: ECG Event Recorder Model Number: WeCardio UN FCC Identifier: RP4WECARDIOUN01 We authorize MiCOM Labs Inc, 575 Boulder Court, Pleasanton, California 94566, USA, to act on our behalf on all matters concerning the above named equipment. Any individual within MiCOM Labs is authorized to act on our behalf and take action on the application. We declare that MiCOM Labs Inc, 575 Boulder Court, Pleasanton, California 94566, USA, is allowed to forward all information related to the approval project to the Federal Communication Commission and to discuss any issues concerning the approval application. Any and all acts carried out by MiCOM Labs on our behalf shall have the same effect as acts of our own. Name: DingHong Mao Date: 2020/5/25 Title: Manager Signature of applicant:

External Photo

Internal Photo BLE ANT

FCC RF Exposure FCC ID: RP4WECARDIOUN01 Applicant: BORSAM Biomedical Instruments Co.,Ltd. Exposure category: General population/uncontrolled environment EUT Type: ECG Event Recorder Device Type: Portable Device FCC Part 2 §2.1093 Evaluation method Accord ing to KDB447498 D01 General RF Exposure Guid ance v06 Sectio n 4.3.1 Standalo ne SAR test exclusio n consid erations:“ Unless specifically required by the publis hed RF exposure KDB procedures, standalo ne 1-g head or body and 10-g extremit y SAR evaluatio n for general population exposure condit ions, by measure ment or numeric al simulatio n, is not required when the correspondin g SAR Test Exclusio n Threshold condit ion, listed below, i s satis fied. These test exclusion condit io ns are based on source-based time-averaged maximum conducted output po wer of the RF channel requiring evaluatio n, adjusted for tune-up tolerance, and the min imum test separatio n dis tance required for the exposure condit io ns.22 The min imum test separatio n dis tance is determin ed by the smallest distance from the antenna and radiatin g structur es or outer surface of the device, accord ing to the host form factor, exposure condit io ns and platform requirements , to any part of the body or extremit y of a user or bystander (see 5) of sectio n 4.1). To quali fy for SAR test exclu sio n, the test separatio n distances appli ed must be fully explained and justif ied by the o peratin g config urations and exposure condit io ns of the transmit ter and appli cable host platform requirements , typicall y in the SAR measurement or SAR analysis report , accord ing to the required publis hed RF exposure KDB procedures. When no other RF exposure tes tin g or report in g is required, a statement of justif ication and complia nce must be in clu ded in the equipment approval, in li eu of the SAR report , to qualify for the SAR test exclu sio n. When required, the devic e specific condit io ns described in the other publis hed RF exposure KDB pr ocedures must be satis fied before a pplyi ng these SAR test exclusion provi sio ns; for example, handheld PTT two-way radios, handsets , l aptops & table ts etc. 23 “[(max. power of channel, in clu ding tune-up tole rance, mW)/ (min . test separatio n distance, mm)] · [√f (GHz)]≤ 3.0 for 1-g SAR and ≤ 7.5 for 10-g extremit y SAR, where: • f (GHz) is the RF channel transmit frequency in GHz • Power and distance are rounded to the nearest mW and mm before calculatio n • The res ult is rounded to one decimal place for comparison • 3.0 and 7.5 are re ferred to as the numeric thres hold s in the step 2 below The test exclusio ns are applicable only when the minimum test separatio n distance is ≤ 50 mm and for transmission frequencies between 100 MHz and 6 GHz. When the minimum test separa tio n distance is <5 mm, a distance of 5 mm accord ing to 5) in sectio n 4.1 is applied to determin e SAR test exclusion. Maximum Conducted Power Results Bluetooth BLE Channel Channel 0 Channel 19 Channel 39 Test Results(dBm) -9.117 -9.620 -6.716 Target (dBm) -10 -10 -7 Tolerance ±(dB) ±1 ±1 ±1 Maximum Evaluation Results Bluetooth Channel Fre.(MHz) Antenna Distance （mm） RF output power (including tune-up tolerance) SAR Test Exclusion Threshold SAR Test Exclusion dBm mW 39 2480 5 -6 0.25 0.079＜3.0 Ye s Conclusion The measurement results comply wit h the FCC Limit per 47 CFR 2.1093 for the uncontrolled RF Exposure and SAR Excl usion Threshold per KDB447498 D01 General RF Exposure Guidance v06.

Report No.:SET2020-04218 CCIC-SET/ TRF:IRF(2019-05-23) Page 1 of 34 RF TEST REPORT Report No.: SET2020-04218 Product Name: ECG Event Recorder FCC ID: RP4WECARDIOUN01 Model No. : WeCardio UN Applicant: BORSAM Biomedical Instruments Co.,Ltd. Address: Rm. 502, University Innovation PARK Lishan road Xi, Shenzhen, China. Dates of Testing: 04/22/2020 —05/06/2020 Issued by: CCIC Southern Testing Co., Ltd. Lab Location: Electronic Testing Building, No. 43 Shahe Road, Xili Street, Nanshan District, Shenzhen, Guangdong, China. Tel: 86 755 26627338 Fax: 86 755 26627238 This test report consists of 34 pages in total. It may be duplicated completely for legal use with the approval of the applicant. It should not be reproduced except in full, without the written approval of our laboratory. The client should not use it to claim product endorsement by CCIC-SET. The test results in the report only apply to the tested sample. The test report shall be invalid without all the signatures of testing engineers, reviewer and approver. Any objections must be raised to CCIC-SET within 15 days since the date when the report is received. It will not be taken into consideration beyond this limit. Report No.:SET2020-04218 CCIC-SET/ TRF:IRF(2019-05-23) Page 2 of 34 Test Report Product Name ...................... : ECG Event Recorder Brand Name ......................... : WeCardio Trade Name .......................... : WECARDIO Applicant .............................. : BORSAM Biomedical Instruments Co.,Ltd. Applicant Address ............... : Rm. 502, University Innovation PARK Lishan road Xi, Shenzhen, China， Manufacturer ........................ : BORSAM Biomedical Instruments Co.,Ltd. Manufacturer Address ........ : Rm. 502, University Innovation PARK Lishan road Xi, Shenzhen, China Test Standards ..................... : 47 CFR Part 15 Subpart C：Radio Frequency Devices ANSI C63.10-2013：American National Standard for Testing Unlicensed Wireless Devices KDB558074 D01 DTS Meas Guidance v05r02 Test Result ........................... : PASS Tested by ............................ : 2020.05.06 Vincent, Test Engineer Reviewed by ......................... : 2020.05.06 Chris You, Senior Engineer Approved by ........................ : 2020.05.06 Shuangwen Zhang, Manager Report No.: SET2020-04218 CCIC-SET/ TRF:IRF(2019-05-23) Page 3 of 34 TABLE OF CONTENTS RF TEST REPORT ....................................................................................................................... 1 1. GENERAL INFORMATION ................................................................................................. 4 1.1. EUT Description .................................................................................................................... 4 1.2. Test Standards and Results ..................................................................................................... 5 1.3. Table for Supporting Units ..................................................................................................... 6 1.4. Facilities and Accreditations .................................................................................................. 7 2. 47 CFR PART 15C REQUIREMENTS ................................................................................. 8 2.1. Antenna requirement .............................................................................................................. 8 2.2. Peak Output Power................................................................................................................. 9 2.3. 6dB Bandwidth .................................................................................................................... 10 2.4. Conducted Band Edges and Spurious Emissions ................................................................. 11 2.5. Power spectral density (PSD) .............................................................................................. 13 2.6. Radiated Band Edge and Spurious Emission ....................................................................... 15 2.7. Conducted Emission ............................................................................................................ 23 3. LIST OF MEASURING EQUIPMENT .............................................................................. 27 4. UNCERTAINTY OF EVALUATION .................................................................................. 28 APPENDIX A ............................................................................................................................... 29 Change History Issue Date Reason for change 1.0 2020.05.06 First edition Report No.: SET2020-04218 CCIC-SET/ TRF:IRF(2019-05-23) Page 4 of 34 1. General Information 1.1. EUT Description EUT Type ECG Event Recorder Frequency Range Bluetooth LE 2402MHz~2480MHz Channel Number Bluetooth LE 40 Bit Rate of Transmitter Bluetooth LE 1Mbps Modulation Type Bluetooth LE GFSK Antenna Type Ceramic Note 1: For a more detailed description, please refer to Specification or User’s Manual supplied by the applicant and/or manufacturer. Note 2: The EUT was programmed to be in continuously transmitting mode and the transmit duty cycle is not less than 98%. Report No.: SET2020-04218 CCIC-SET/ TRF:IRF(2019-05-23) Page 5 of 34 1.2. Test Standards and Results The objective of the report is to perform testing according to 47 CFR Part 15 Subpart C (Bluetooth, 2.4GHz ISM band radiators) for the EUT FCC Certification: No. Identity Document Title 1 47 CFR Part 15 Subpart C 2017 Radio Frequency Devices 2 ANSI C63.10-2013 American National Standard for Testing Unlicensed Wireless Devices Test detailed items/section required by FCC rules and results are as below: No. Section in CFR 47 Description Result 1 15.203 Antenna Requirement PA S S 2 15.247(b) Peak Output Power PASS 3 15.247(a) Bandwidth PASS 4 15.247(d) Conducted Band Edges and Spurious Emission PA S S 5 15.247(e) Power spectral density (PSD) PASS 6 15.207 Conducted Emission …

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15C Setup photo