2ASFFAC027Impala

AliveCor is a registered trademark of AliveCor, Inc. in the United States and other jurisdictions. Instructions for Use (IFU) for Impala System (AC-027) 27LB07.X03 AliveCor, Inc. 189 N. Bernardo Avenue, Ste 100 Mountain View, CA 94043, USA © 2023 AliveCor, Inc. ℞ only CAUTION: Federal law restricts this device to sale by or on the order of a physician. Instructions for Use for Impala System 27LB07.X03 Page 2 of 36 Table of Contents Introduction .................................................................................................................................. 4 Indications For Use ..................................................................................................................... 4 Guide to Parts .............................................................................................................................. 5 Accessories ................................................................................................................................. 6 Warnings ...................................................................................................................................... 8 Cautions ⚠ ................................................................................................................................... 9 Features & Functionality ............................................................................................................. 9 Getting Started ........................................................................................................................... 10 Setting up your Impala for the first time ................................................................................. 10 Recording an ECG ..................................................................................................................... 10 Environmental Specifications .................................................................................................. 13 Expected Service Life ............................................................................................................... 13 Maintenance ............................................................................................................................... 14 Cleaning Impala Device ......................................................................................................... 14 Battery Replacement Instructions .......................................................................................... 15 Electromagnetic & Other Interferences ................................................................................... 16 FCC Compliance ........................................................................................................................ 16 Ingress Protection Marking ...................................................................................................... 16 Essential Performance .............................................................................................................. 17 Applied Parts ............................................................................................................................. 18 Troubleshooting ........................................................................................................................ 19 Electrical Safety ......................................................................................................................... 20 Privacy and Security ................................................................................................................. 24 Security Responsibility .......................................................................................................... 24 Malicious Software Protection ............................................................................................... 24 Equipment Symbols .................................................................................................................. 26 Impala Specifications ................................................................................................................ 27 Physician’s Guide ...................................................................................................................... 29 Introduction ............................................................................................................................ 29 Using the Impala ECG Device ............................................................................................... 31 Configuration of Standard and Reduced ECG Lead Sets ..................................................... 32 Impala ECG Device’s approach to Reduced Lead Set .......................................................... 33 Using Synthesized Leads on the ECG Report ...................................................................... 34 Choosing Between Leadset 1 [I, II, V1, V4] and Leadset 2 [I, II, V2, V4] .............................. 36 Integration of Corvair within Impala and Reference Guide .................................................... 37 Instructions for Use for Impala System 27LB07.X03 Page 3 of 36 Introduction 1. Impala is a portable electrocardiograph that records four leads, derives four leads, and synthesizes four leads to create a 12-lead ECG recording for diagnostic purposes. a. The device consists of the following components: ▪ Impala hardware, which connects to standard gel-based ECG electrodes (off the shelf) to measure and record ECG leads. ▪ Impala app, which provides the user interface and ECG display functions. The Impala app functions on a smart device such as a smartphone or a tablet. 2. The Impala hardware measures and records 4 leads (‘Recorded Leads’). a. The device can record the following sets: i. Leads I, II, V2 and V4 (Default) ii. Leads I, II, V1 and V4 (Alternate) b. The Impala app uses the Recorded Leads to derive the remaining limb leads (i.e. Leads III, aVR, aVL, aVF) using the s…

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189 N Bernardo Ave, Suite 100 T 650.439.1596 Mountain View, CA 94043 F 650.618.2799 AliveCor Confidential alivecor.com Date: 17 th May 2023 Federal Communications Commissions Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, MD 21046 RE: CFR 47 §2.911 (d)(5) Attestation FCC ID: 2ASFFAC027 FRN: 0028200780 1. AliveCor Inc. (“the applicant”) certifies that the equipment for which authorization is sought is not “covered” equipment prohibited from receiving an equipment authorization pursuant to section 2.903 of the FCC rules. 2. AliveCor Inc. (“the applicant”) certifies that, as of the date of the filing of the application, the applicant is not identified on the Covered List as an entity producing “covered” equipment and is not an affiliate or subsidiary of an entity identified on the Covered List. Sincerely yours, Name: Samip Shah Job Title: VP, RA & QA Company Name: AliveCor Inc.

189 N Bernardo Ave, Suite 100 T 650.439.1596 Mountain View, CA 94043 F 650.618.2799 AliveCor Confidential alivecor.com Date: 5/17/2023 Federal Communications Commissions Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, MD 21046 RE: CFR 47 §2.911 (d)(7) Agent Designation Attestation FCC ID: 2ASFFAC027 FRN: 0028200780 To whom it may concern: Samip Shah (grantee) AliveCor Inc. (“the applicant”) as required by section §2.911(d)(7), will also serve as the agent for service of process for the above referenced FCC ID. The applicant acknowledges that they will maintain an agent for no less than one year after the grantee has terminated all marketing and importation or the conclusion of any Commission- related proceeding involving the equipment. The applicant further acknowledges their responsibility under CFR 47 §2.929(c) to inform the FCC whenever the agent information changes. Contact Person: Samip Shah Company Name: AliveCor Inc. FCC FRN: 0028200780 Company US Address: 189 N. Bernardo Avenue, Suite 100, Mountain View, CA 94043 Email: [email protected] Sincerely yours, Contact Person: Samip Shah Company Name: AliveCor Inc. Company Address: 189 N. Bernardo Avenue, Suite 100, Mountain View, CA 94043

189 N Bernardo Ave, Suite 100 T 650.439.1596 Mountain View, CA 94043 F 650.618.2799 AliveCor Confidential alivecor.com Date: 20th March 2023 Federal Communications Commission Equipment Authorization branch 7435 Oakland Mills Road Columbia, MD 21046 To whom it may concern: I, the undersigned, hereby authorize UL Verification Services Inc. to act on our behalf in all manners relating to application for equipment authorization, including signing of all documents relating to these matters. Any and all acts carried out by UL Verification Services Inc. on our behalf shall have the same effect as acts of our own. I, the undersigned, hereby certify that we are not subject to a denial of federal benefits, that includes FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. 853(a). In authorizing UL Verification Services Inc. as our representative, we still recognize that we are responsible to: a) comply with the relevant provisions of the certification program; b) make all necessary arrangements for the conduct of the evaluation, including provision for examining documentation and access to all areas, records (including internal audit reports) and personnel for the purposes of evaluation (e.g. testing, inspection, assessment, surveillance, reassessment) and resolution of complaints; c) make claims regarding certification only in respect of the scope for which certification has been granted; d) do not use our product certification in such a manner as to bring the Certification Division into disrepute and not make any statement regarding our product certification which the Certification Division may consider misleading or unauthorized; e) upon suspension or cancellation of certification, discontinue use of all advertising matter that contains any reference thereto and return any certification documents as required by the Certification Division; f) use certification only to indicate the products are certified as being in conformity with specified standards; 189 N Bernardo Ave, Suite 100 T 650.439.1596 Mountain View, CA 94043 F 650.618.2799 AliveCor Confidential alivecor.com g) endeavor to ensure that no certificate or report nor any part thereof is used in a misleading manner; h) ensure that any reference to our product certification in communication media such as documents, brochures or advertising, complies with the requirements of the Certification Division; i) keep a record of all complaints made known to the us relating to the product’s compliance with requirements of the relevant standard and to make these records available to the when requested; j) take appropriate action with respect to such complaints and any deficiencies found in products or services that affect compliance with the requirements for certification; k) document the actions taken. This authorization is valid until further written notice from the applicant. Sincerely Yours, Samip Shah, VP of RAQA AliveCor Inc. REMARK: 1. This authorization letter will be sent along with your application when filing with UL Verification Services Inc. 2. Please follow the format and type it on company letterhead and send original to us. 3. Authorized signature must be in agreement with grantee code contact in FCC database and Industry Canada contact information.

189 N Bernardo Ave, Suite 100 T 650.439.1596 Mountain View, CA 94043 F 650.618.2799 AliveCor Confidential alivecor.com Date: 27 th December 2023 Federal Communications Commission 7435 Oakland Mills Road Columbia MD 21046 Subject: Request for Confidentiality FCC ID: 2ASFFAC027 To Whom It May Concern: Pursuant to the provisions of Sections 0.457 and 0.459 of the Commission’s rules (47 CFR §§ 0.457, 0.459), we are requesting the Commission to withhold the following attachments as confidential documents from public disclosure indefinitely. Schematic Diagram Block Diagram Theory of Operation Above mentioned document contains detailed system and equipment description are considered as proprietary information in operation of the equipment. The public disclosure of the above documents might be harmful to our company and would give competitor an unfair advantage in the market. In additional to above mentioned documents, pursuant to Public Notice DA 04-1705 of the Commission’s policy, in order to comply with the marketing regulations in 47 CFR §2.803 and the importation rules in 47 CFR §2.1204, while ensuring that business sensitive information remains confidential until the actual marketing of newly authorized devices. We are requesting the commission to grant short-term confidentiality request on the following attachments until 1 st May 2024 External Photos Internal Photos Test Setup Photos User Manual It is our understanding that all measurement test reports, FCC ID label format and correspondent during certification review process cannot be granted as confidential documents and those information will be available for public review once the grant of equipment authorization is issued. 189 N Bernardo Ave, Suite 100 T 650.439.1596 Mountain View, CA 94043 F 650.618.2799 AliveCor Confidential alivecor.com Best Regards Samip Shah VP, Regulatory Affairs and Quality Assurance AliveCor Inc. 27 th December 2023

External Photos Kardia 12L ECG system: Isometric view: Orthographic top: Orthographic front: Orthographic boBom: Orthographic side 1: Orthographic side 2: Orthographic back: Case dimensions (mm):

Exhibit: FCC ID label format and label location FCC ID: 2ASFFAC027 (As shown with red box, FCC ID is laser marked directly into the back bottom side of the main device body)

Internal Pictures Kardia 12L ECG system: PCBA: Parts 1: Parts 2: Drawing dimensions:

TEST REPORT Report Number. : 14554504-E3V1 Applicant : AliveCor Inc. 189 N. Bernardo Avenue, Ste 100 Mountain View, CA, 94043 US Model : AC-027 Brand : Alivecor FCC ID : 2ASFFAC027 IC : 25747-AC027 EUT Description : Impala Test Standard(s) : FCC Part 1 Subpart I FCC Part 2 Subpart J RSS 102 ISSUE 5 Date Of Issue: 2023-04-18 Prepared by: UL VERIFICATION SERVICES 47173 Benicia Street Fremont, CA 94538 U.S.A. TEL: (510) 319-4000 FAX: (510) 661-0888 REPORT NO: 14554504-E3V2 DATE: 2023-06-15 FCC ID: 2ASFFAC027 IC: 25747-AC027 Page 2 of 8 UL VERIFICATION SERVICES INC. FORM NO: CCSUP4701I 47173 BENICIA STREET, FREMONT, CA 94538, USA TEL: (510) 319-4000 FAX: (510) 661-0888 This report shall not be reproduced except in full, without the written approval of . UL Verification Services Inc. Revision History Rev. Issue Date Revisions Revised By V1 2023-04-18 Initial Issue --- V2 2023-06-15 Antenna gain updated Henry Lau REPORT NO: 14554504-E3V2 DATE: 2023-06-15 FCC ID: 2ASFFAC027 IC: 25747-AC027 Page 3 of 8 UL VERIFICATION SERVICES INC. FORM NO: CCSUP4701I 47173 BENICIA STREET, FREMONT, CA 94538, USA TEL: (510) 319-4000 FAX: (510) 661-0888 This report shall not be reproduced except in full, without the written approval of . UL Verification Services Inc. TABLE OF CONTENTS 1. ATTESTATION OF TEST RESULTS ..................................................................................4 2. TEST METHODOLOGY ......................................................................................................5 3. REFERENCES ....................................................................................................................5 4. FACILITIES AND ACCREDITATION ..................................................................................5 5. EQUIPMENT UNDER TEST ................................................................................................6 5.1. DESCRIPTION OF EUT ...............................................................................................6 5.2. MAXIMUM OUTPUT POWER .......................................................................................6 5.3. DESCRIPTION OF AVAILABLE ANTENNAS ...............................................................6 6. STANDALONE SAR TEST EXCLUSION CONSIDERATIONS ...........................................6 6.1. FCC ..............................................................................................................................6 6.2. ISED .............................................................................................................................7 REPORT NO: 14554504-E3V2 DATE: 2023-06-15 FCC ID: 2ASFFAC027 IC: 25747-AC027 Page 4 of 8 UL VERIFICATION SERVICES INC. FORM NO: CCSUP4701I 47173 BENICIA STREET, FREMONT, CA 94538, USA TEL: (510) 319-4000 FAX: (510) 661-0888 This report shall not be reproduced except in full, without the written approval of . UL Verification Services Inc. 1. ATTESTATION OF TEST RESULTS COMPANY NAME: AliveCor Inc. 189 N. Bernardo Avenue, Ste 100 Mountain View, CA, 94043 US EUT DESCRIPTION: Impala MODEL: AC-027 APPLICABLE STANDARDS STANDARD TEST RESULTS FCC PART 1 SUBPART I & PART 2 SUBPART J Complies RSS 102 ISSUE 5 Complies UL Verification Services Inc. tested the above equipment in accordance with the requirements set forth in the above standards. The test results show that the equipment tested is capable of demonstrating compliance with the requirements as documented in this report. The results documented in this report apply only to the tested sample, under the conditions and modes of operation as described herein. It is the manufacturer's responsibility to assure that additional production units of this model are manufactured with identical electrical and mechanical components. All samples tested were in good operating condition throughout the entire test program. Measurement Uncertainties are published for informational purposes only and were not taken into account unless noted otherwise. This document may not be altered or revised in any way unless done so by UL Verification Services Inc. and all revisions are duly noted in the revisions section. Any alteration of this document not carried out by UL Verification Services Inc. will constitute fraud and shall nullify the document. This report must not be used by the client to claim product certification, approval, or endorsement by A2LA, NIST, any agency of the Federal Government, or any agency of the U.S. government. Approved & Released For UL Verification Services Inc. By: Prepared By: Dan Coronia Henry Lau Operations Leader Senior Project Engineer CONSUMER TECHNOLOGY DIVISION CONSUMER TECHNOLOGY DIVISION UL Verification Services Inc. UL Verification Services Inc. REPORT NO: 14554504-E3V2 DATE: 2023-06-15 FCC ID: 2ASFFAC027 IC: 25747-AC027 Page 5 of 8 UL VERIFICATION SERVICES INC. FORM NO: CCSUP4701I 47173 BENICIA STREET, FREMONT, CA 94538, USA TEL: (510) 319-4000 FAX: (510) 661-0888 This report shall not be reproduced except in full, without the written approval of . UL Verification Services Inc. 2. TEST METHODOLOGY All calculations were made in accordance with FCC Parts 1.1310, 2.1091, 2.1093, KDB 447498 D01 v06, KDB 447498 D03 V01, IEEE Std C95.1-2005, IEEE Std C95.3-2002, IC Safety Code 6 and RSS 102 Issue 5. 3. REFERENCES This report contains data provided by the customer which can impact the validity of results. UL Verification Services Inc. is only responsible for the validity of results after the integration of the data provided by the customer. All measurements were made as documented in test report UL Verification Services Inc. Document 14554504-E1 for operation in the 2402 – 2480MHz Band . Output power, Duty cycle and Antenna gain data is excerpted from the applicable test reports and product documentation provided by the applicant. 4. FACILITIES AND ACCREDITATION UL Verification Services is accredited by A2LA, certification #0751.05, for all testing performed within the scope of this report. T…

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TEST REPORT Report Number. : 14554504-E1V4 Applicant : AliveCor Inc. 189 N. Bernardo Avenue, Ste 100 Mountain View, CA, 94043 US Model : AC-027 Brand : Alivecor FCC ID : 2ASFFAC027 IC : 25747-AC027 EUT Description : Impala Test Standard(s) : FCC 47 CFR PART 15 SUBPART C ISED RSS-247 ISSUE 2 ISED RSS-GEN ISSUE 5 + A1 + A2 Date Of Issue: 2023-10-23 Prepared by: UL VERIFICATION SERVICES 47173 Benicia Street Fremont, CA 94538 U.S.A. TEL: (510) 319-4000 FAX: (510) 661-0888 REPORT NO: 14554504-E1V4 DATE: 2023-10-23 FCC ID: 2ASFFAC027 IC: 25747-AC027 Page 2 of 63 UL VERIFICATION SERVICES 47173 Benicia Street, Fremont, CA 94538; USA TEL:(510) 319-4000 FAX:(510) 661-0888 This report shall not be reproduced except in full, without the written approval of UL VERIFICATION SERVICES REPORT REVISION HISTORY Rev. Issue Date Revisions Revised By V1 2023-04-18 Initial Issue -- V2 2023-04-19 Section 7 & 10.5 Updated Henry Lau V3 2023-06-15 Antenna gain updated Henry Lau V3 2023-10-23 Section 11 updated Henry Lau REPORT NO: 14554504-E1V4 DATE: 2023-10-23 FCC ID: 2ASFFAC027 IC: 25747-AC027 Page 3 of 63 UL VERIFICATION SERVICES 47173 Benicia Street, Fremont, CA 94538; USA TEL:(510) 319-4000 FAX:(510) 661-0888 This report shall not be reproduced except in full, without the written approval of UL VERIFICATION SERVICES TABLE OF CONTENTS REPORT REVISION HISTORY ................................................................................................. 2 TABLE OF CONTENTS ............................................................................................................ 3 1. ATTESTATION OF TEST RESULTS ................................................................................. 5 2. TEST RESULTS SUMMARY .............................................................................................. 6 3. TEST METHODOLOGY ..................................................................................................... 7 4. FACILITIES AND ACCREDITATION ................................................................................. 7 5. DECISION RULES AND MEASUREMENT UNCERTAINTY .............................................. 8 5.1. METROLOGICAL TRACEABILITY .............................................................................. 8 5.2. DECISION RULES ....................................................................................................... 8 5.3. MEASUREMENT UNCERTAINTY ............................................................................... 8 5.4. SAMPLE CALCULATION ............................................................................................ 9 6. EQUIPMENT UNDER TEST ..............................................................................................10 6.1. EUT DESCRIPTION ...................................................................................................10 6.2. MAXIMUM OUTPUT POWER.....................................................................................10 6.3. DESCRIPTION OF AVAILABLE ANTENNAS .............................................................10 6.4. SOFTWARE AND FIRMWARE ...................................................................................10 6.5. WORST-CASE CONFIGURATION AND MODE .........................................................10 6.6. DESCRIPTION OF TEST SETUP ...............................................................................11 7. MEASUREMENT METHOD...............................................................................................13 8. TEST AND MEASUREMENT EQUIPMENT ......................................................................14 9. ANTENNA PORT TEST RESULTS ...................................................................................15 9.1. ON TIME AND DUTY CYCLE .....................................................................................15 9.2. 99% BANDWIDTH ......................................................................................................17 9.2.1. BLE (1Mbps) ........................................................................................................18 9.2.2. BLE (2Mbps) ........................................................................................................19 9.3. 6 dB BANDWIDTH ......................................................................................................20 9.3.1. BLE (1Mbps) ........................................................................................................21 9.3.2. BLE (2Mbps) ........................................................................................................22 9.4. OUTPUT POWER.......................................................................................................23 9.4.1. BLE (1Mbps) ........................................................................................................24 9.4.2. BLE (2Mbps) ........................................................................................................25 9.5. AVERAGE POWER ....................................................................................................26 REPORT NO: 14554504-E1V4 DATE: 2023-10-23 FCC ID: 2ASFFAC027 IC: 25747-AC027 Page 4 of 63 UL VERIFICATION SERVICES 47173 Benicia Street, Fremont, CA 94538; USA TEL:(510) 319-4000 FAX:(510) 661-0888 This report shall not be reproduced except in full, without the written approval of UL VERIFICATION SERVICES 9.5.1. BLE (1Mbps) ........................................................................................................27 9.5.2. BLE (2Mbps) ........................................................................................................28 9.6. POWER SPECTRAL DENSITY ..................................................................................29 9.6.1. BLE (1Mbps) ........................................................................................................30 9.6.2. BLE (2Mbps) .................................................................…

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ANTENNA GAIN AND PATTERN MEASUREMENT REPORT For Gain value reference FOR IMPALA PART/MODEL NUMBER: AC-027 DATE ISSUED: January 3, 2024 REPORT NUMBER: 14554504-O1V4 Prepared for AliveCor, Inc 189 N. Bernardo Avenue, Ste 100 Mountain View, California, 94043 U.S.A. Prepared by UL VERIFICATION SERVICES INC. 47173 BENICIA STREET FREMONT, CA 94538, U.S.A. TEL: (510) 319-4000 FAX: (510) 661-0888 REPORT NO: 14554504-O1V4 DATE: January 3, 2024 EUT: Impala PART/MODEL: AC-027 Page 2 of 17 UL VERIFICATION SERVICES INC. 47173 BENICIA STREET, FREMONT, CA 94538, USA TEL: (510) 319-4000 This report shall not be reproduced except in full, without the written approval of UL Verification Services Inc. Revision History Rev. Issue Date Revisions Revised By V1 05/31/2023 Initial Issue V2 06/15/2023 Re-measured data with correct EUT configuration E. Budhbhatti V3 10/25/2023 Corrected Test Freq. on Page 7 to 2402MHz V4 01/03/2024 Revised End Product Description G.Rincand REPORT NO: 14554504-O1V4 DATE: January 3, 2024 EUT: Impala PART/MODEL: AC-027 Page 3 of 17 UL VERIFICATION SERVICES INC. 47173 BENICIA STREET, FREMONT, CA 94538, USA TEL: (510) 319-4000 This report shall not be reproduced except in full, without the written approval of UL Verification Services Inc. TABLE OF CONTENTS 1 ATTESTATION OF TEST RESULTS ............................................................................................. 4 2 TEST METHODOLOGY ................................................................................................................. 5 3 TEST FACILITY ............................................................................................................................. 5 4 TEST AND MEASUREMENT EQUIPMENT ................................................................................... 5 5 DEVICE UNDER TEST INFORMATION ......................................................................................... 6 5.1 END PRODUCT DESCRIPTION ............................................................................................. 6 6 RESULT SUMMARY ...................................................................................................................... 7 6.1 Passive Antenna Pattern ......................................................................................................... 7 7 PLOTS ........................................................................................................................................... 8 7.1 3D PASSIVE- 2402 MHz ......................................................................................................... 8 7.2 3D PASSIVE- 2440 MHz ....................................................................................................... 11 7.3 3D PASSIVE- 2480 MHz ....................................................................................................... 14 8 TEST SETUP ............................................................................................................................... 17 REPORT NO: 14554504-O1V4 DATE: January 3, 2024 EUT: Impala PART/MODEL: AC-027 Page 4 of 17 UL VERIFICATION SERVICES INC. 47173 BENICIA STREET, FREMONT, CA 94538, USA TEL: (510) 319-4000 This report shall not be reproduced except in full, without the written approval of UL Verification Services Inc. 1 ATTESTATION OF TEST RESULTS Company Name and Address AliveCor. 189 N. Bernardo Avenue, Ste 100 Mountain View, California, 94043 U.S.A. EUT Description Impala Part/Model AC-027 Date Tested 06/13/2023 APPLICABLE STANDARDS STANDARD TEST RESULTS Non-standard Test Method* *Reference Section 2 Test Methodology Information Only UL Verification Services Inc. tested the above equipment in accordance with the requirements set forth in the above standards. The test results show that the equipment tested is capable of demonstrating compliance with the requirements as documented in this report. The results documented in this report apply only to the tested sample, under the conditions and modes of operation as described herein. It is the manufacturer's responsibility to assure that additional production units of this model are manufactured with identical elect…

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