2AYAJ-BS1OR Base Station

Patient Manual Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. Canary Tibial Extension with CHIRP System Patient Manual Read this manual carefully. If you have additional questions after reading this manual, contact your doctor. How to Contact Canary Medical Customer Assistance Phone: 1-800-123-9876 Fax: 1-800-789-1234 E-mail: [email protected] Internet: www.canarymedical.com Mail: Canary Medical, LLC. 2710 Loker Ave. West Suite 350 Carlsbad, CA 92010 Page | 3 Your Knee Implant Information (Your health care provider can provide this information.) TypeZimmer Persona and Canary Tibial Extension with CHIRP System Model Number CTE 1 Serial Number Implant Date Your CanaryMedical Patient Registration Information Website Username Password Page | 4 TABLE OF CONTENTS GLOSSARY...................................................................................................................................................... 5 INTRODUCTION ............................................................................................................................................. 7 SETTING UP YOUR PATIENT ACCOUNT ......................................................................................................... 9 YOUR KNEE IMPLANT WITH CANARY TIBIAL EXTENSION & CHIRP SYSTEM ............................................... 19 HOW TO SET UP YOUR CHIRP HOME BASE STATION.................................................................................. 21 YOUR PATIENT DASHBOARD ....................................................................................................................... 35 MAINTAINING YOUR CTE WITH CHIRP SYSTEM .......................................................................................... 38 TROUBLESHOOTING .................................................................................................................................... 39 FREQUENTLY ASKED QUESTIONS (FAQS) .................................................................................................... 41 Page | 5 GLOSSARY CADENCE The steps you take per minute, as measured by the CHIRP System CAREGIVER An adult family member, friend, or personal assistant who can help you with your care and who you allow to have access to your personal and health information. CHIRP This stands for Canary Health Implanted Reporting Processor. This is the software and electronics found within your CTE knee implant. The software and electronics collect information on your activity level and quality of movement after you receive your new knee. CTE Canary Tibial Extension DISTANCE This is how far you have walked in miles on a given day as measured by the CHIRP System. EHR Electronic Health Record. This is the medical information stored electronically by your doctor’s office and in your Patient Account. You have the right to access this information. GAIT Refers to the manner or way in which a person walks. HOME BASE STATION The unit placed in your home which collects activity information from your CTE knee implant and sends it to a website, where you and your doctor view it. PATIENT DASHBOARD Your page where you log in on the Canary Medical website to view information collected by the CTE and CHIRP System. Please note that the data collected each day will not be available on the dashboard until the following day. PROSTHESIS Medical term for your knee implant. RANGE OF MOTION This is a measure of how much your knee can bend and straighten. Page | 6 STEP COUNT The number of steps you take during the most active part of your day. STRIDE The amount of distance covered between the time when one foot hits the ground and then the same foot hits the ground again. USB CABLE A cable shipped with your Home Base Station that allows it to connect with your computer. TKA Total Knee Arthroplasty Also called total knee replacement. This is the replacement of your natural knee joint with an implant (prosthesis). WALKING SPEED This is a measure of how far you walk over a period of time. Page | 7 INTRODUCTION With the help of your doctor, you have decided to have a procedure called a total knee arthroplasty (TKA). TKA is also called total knee replacement. The TKA procedure replaces diseased or damaged parts of your natural knee joint with an implant (prosthesis) device. The implant you will receive is a Zimmer Biomet Persona® Personalized Knee System with a Canary™ Tibial Extension (CTE). The CTE is a part of the knee implant that will help to stabilize your new knee. It also contains software and electronics that will collect information about your activity level and how well you walk immediately after surgery and over a long period of time. The software and electronics are part of a technology package called the Canary Health Implanted Reporting Processor (CHIRP). CHIRP allows information about how you are walking to be collected from your CTE implant. The data is processed and transmitted to a secure website where both you and your doctor will be able to view information about your activity level on your respective Dashboards. This helps you and your doctor to monitor your activity level, without the need for an office visit. This may help you and your doctor do a better job of monitoring the health of your knee. There are several steps in the process of receiving your knee implant and using your CHIRP System. They are generally outlined below: 1. Meet with your doctor and decide to go forward with TKA surgery, including the CTE implant. 2. Use the Quick Start Guide your doctor’s office gave you, and this manual, to create a patient account. You must create an account prior to surgery to receive the Canary CTE Implant. 3. Receive a Home Base Station and connection accessories shipped from Canary Medical. Along with your knee implant, this equipment is part of the CHIRP System. 4. Set up your Home Base Station using the instructions in this manual and a Quick Start Guide shipped…

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Manufactured for: Canary Medical, LLC. 2710 Loker Ave. West Suite 350 Carlsbad, CA 92010 www.canarymedical.com E-mail: [email protected] Customer Assistance: 1-800-123-9876 PN. K01-HBS-300003, Rev2 Page | 46 US Federal Communications Commission (FCC) •FCC ID: 2AYAJ-BS1 •This transmitter is authorized by rule under the Medical Device Radiocommunication Service (in part 95 of the FCC Rules) and must not cause harmful interference to stations operating in the 400.150–406.000 MHz band in the Meteorological Aids (i.e., transmitters and receivers used to communicate weather data), the Meteorological Satellite, or the Earth Exploration Satellite Services and must accept interference that may be caused by such stations, including interference that may cause undesired operation. This transmitter shall be used only in accordance with the FCC Rules governing the Medical Device Radiocommunication Service. Analog and digital voice communications are prohibited. Although this transmitter has been approved by the Federal Communications Commission, there is no guarantee that it will not receive interference or that any particular transmission from this transmitter will be free from interference. This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment. •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. •IMPORTANT: Changes or modifications to this product not authorized by Canary Medical could void the FCC Certification and negate your authority to operate this product. FCC RF Exposure statement

June 16, 2021 Nemko Canada Inc. 303 River Road Ottawa, ON Canada K1V 1H2 REQUEST FOR CONFIDENTIALITY FOR FCC Name of Applicant: Canary Medical USA LLC Address: 2710 Loker Ave West, Suite 350 City: Carlsbad, CA 92010 Country: USA FCC ID: 2AYAJ-BS1, 2AYAJ-CTE Pursuant to Sections 0.457(d) and 0.459 of the commission’s rules and Industry of Canada Regulations, we hereby request that the following documents be held under long term confidentiality. Short Term Confidentiality for 180 days 1. Test Setup Photographs 2. External Photos Permanent Confidentiality: 1. Schematics 2. Bill of Materials 3. Block Diagram 4. Operational Description 5. Internal Photos 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. These devices are available only to trained health care providers or patients under a doctor’s prescription, and internal circuitry is not accessible to users. Dated: 16-JUNE-2021 Signed: _____________________ Printed: Peter Schiller Title: Sr. Vice President, Research & Development

External Photos

IP22 (833) 722-6279 A Made in Canada FCC ID: 2AYAJ-BS1 For Use with Canturio™ - TE Canturio™ - TE Home Base Station (01)00860003118320 (21)123456 *+H124435570001141A* *+$123456A20A.*

ONE WORLD  OUR APPR OVAL www.nemko.com 1. Declaration of RF exposure MPE calculations FCC ID: 2AYAJ-BS1 Model number: BS1 Manufacturer: Canary Medical 2. Attestation ATTESTATION: I attest that the testing was performed or supervised by me; that the test measurements were made in accordance with the above-mentioned departmental standard(s), and that the radio equipment identified in this application has been subject to all applicable test conditions specified in the departmental standards and all of the requirements of the standards have been met. Signature: Date: January 11, 2021 Name: Martha Espinoza Test report cover sheet - MPE

This report must not be used to claim product certification, approval, or endorsement by NVLAP, NIST, or any agency of the U.S. Government. This Report shall not be reproduced, except in full without written approval of the laboratory. Canary Medical CTE with CHIRP System (Base Station) FCC 15.249:2020 2400 - 2483.5 MHz Transceiver Report: CAAL0013.2, Issue Date: November 23, 2020 NVLAP LAB CODE: 200676-0 CERTIFICATE OF TEST 2018-09-14 Product compliance is the responsibility of the client; therefore, the tests and equipment modes of operation represented in this report were agreed upon by the client, prior to testing. The results of this test pertain only to the sample(s) tested. The specific description is noted in each of the individual sections of the test report supporting this certificate of test. This report reflects only those tests from the referenced standards shown in the certificate of test. It does not include inspection or verification of labels, identification, marking or user information. As indicated in the Statement of Work sent with the quotation, Element’s standard process is to always use the latest published version of the test methods even when earlier versions are cited in the test specification. Issuance of a purchase order was de facto acceptance of this approach. Otherwise, the client would have advised Element in writing of the specific version of the test methods they wanted applied to the subject testing. Last Date of Test: October 12, 2020 Canary Medical EUT: CTE with CHIRP System (Base Station) Radio Equipment Testing Standards Specification Method FCC 15.249:2020 ANSI C63.10:2013 Results Method Clause Test Description Applied Results Comments 6.2 Powerline Conducted Emissions Yes Pass 6.5, 6.6 Field Strength of Harmonics and Spurious Radiated Emissions Yes Pass 6.6 Field Strength of Fundamental Yes Pass 7.5 Duty Cycle Yes Pass Deviations From Test Standards None Approved By: Victor Ratinoff, Operations Manager Report No. CAAL0013.22/28 REVISION HISTORY 2018.07.17 Revision Number Description Date (yyyy-mm-dd) Page Number 00 None Report No. CAAL0013.23/28 ACCREDITATIONS AND AUTHORIZATIONS 2019.03.08 United States FCC - Designated by the FCC as a Telecommunications Certification Body (TCB). Certification chambers, Open Area Test Sites, and conducted measurement facilities are listed with the FCC. A2LA - Accredited by A2LA to ISO / IEC 17065 as a product certifier. This allows Element to certify transmitters to FCC and IC specifications. NVLAP - Each laboratory is accredited by NVLAP to ISO 17025 Canada ISED - Recognized by Innovation, Science and Economic Development Canada as a Certification Body (CB) and as a CAB for the acceptance of test data. European Union European Commission – Within Element, we have a EU Notified Body validated for the EMCD and RED Directives. Australia/New Zealand ACMA - Recognized by ACMA as a CAB for the acceptance of test data. Korea MSIT / RRA - Recognized by KCC’s RRA as a CAB for the acceptance of test data. Japan VCCI - Associate Member of the VCCI. Conducted and radiated measurement facilities are registered. Taiwan BSMI – Recognized by BSMI as a CAB for the acceptance of test data. NCC - Recognized by NCC as a CAB for the acceptance of test data. Singapore IDA – Recognized by IDA as a CAB for the acceptance of test data. Israel MOC – Recognized by MOC as a CAB for the acceptance of test data. Hong Kong OFCA – Recognized by OFCA as a CAB for the acceptance of test data. Vietnam MIC – Recognized by MIC as a CAB for the acceptance of test data. SCOPE For details on the Scopes of our Accreditations, please visit: https://www.nwemc.com/emc-testing-accreditations Report No. CAAL0013.24/28 FACILITIES 2019.03.08 California Labs OC01-17 41 Tesla Irvine, CA 92618 (949) 861-8918 Minnesota Labs MN01-10 9349 W Broadway Ave. Brooklyn Park, MN 55445 (612)-638-5136 Oregon Labs EV01-12 6775 NE Evergreen Pkwy #400 Hillsboro, OR 97124 (503) 844-4066 Texas Labs TX01-09 3801 E Plano Pkwy Plano, TX 75074 (469) 304-5255 Washington Labs NC01-05 19201 120 th Ave NE Bothell, WA 98011 (425)984-6600 NVLAP NVLAP Lab Code: 200676-0 NVLAP Lab Code: 200881-0 NVLAP Lab Code: 200630-0 NVLAP Lab Code:201049-0 NVLAP Lab Code: 200629-0 Innovation, Science and Economic Development Canada 2834B-1, 2834B-3 2834E-1, 2834E-3 2834D-1 2834G-1 2834F-1 BSMI SL2-IN-E-1154R SL2-IN-E-1152R SL2-IN-E-1017 SL2-IN-E-1158R SL2-IN-E-1153R VCCI A-0029 A-0109 A-0108 A-0201 A-0110 Recognized Phase I CAB for ISED, ACMA, BSMI, IDA, KCC/RRA, MIC, MOC, NCC, OFCA US0158 US0175 US0017 US0191 US0157 Report No. CAAL0013.25/28 MEASUREMENT UNCERTAINTY TMU.2015.07.10 Measurement Uncertainty When a measurement is made, the result will be different from the true or theoretically correct value. The difference is the result of tolerances in the measurement system that cannot be completely eliminated. To the extent that technology allows us, it has been our aim to minimize this error. Measurement uncertainty is a statistical expression of measurement error qualified by a probability distribution. A measurement uncertainty estimation has been performed for each test per our internal quality document QM205.4.6. The estimation is used to compare the measured result with its "true" or theoretically correct value. The expanded measurement uncertainty (K=2) can be found included as part of the applicable test description page. Our measurement data meets or exceeds the measurement uncertainty requirements of the applicable specification; therefore, the test data can be compared directly to the specification limit to determine compliance. The calculations for estimating measurement uncertainty are based upon ETSI TR 100 028 (or CISPR 16-4-2 as applicable), and are available upon request. The following table represents the Measurement Uncertainty (MU) budgets for each of the tests that may be contained in this report. Test + MU - MU Frequency Accuracy 0.0007% -0.0007% Amplitude Accuracy (dB) 1.2 dB -1.2 d…

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POWERLINE CONDUCTED EMISSIONS WTD.2020.03.25.0 , POWERLINE CONDUCTED EMISSIONS WTD.2020.03.25.0 , photo PSA-ESCI 2020.06.24.2 BETA photos PSA-ESCI 2020.06.24.2 BETA SEB FFB (1).JPG SEB FFB (2).JPG FFB (2) FIELD STRENGTH of HARMONICS and SPURIOUS RADIATED EMISSIONS photo PSA-ESCI 2020.06.24.2 BETA photos PSA-ESCI 2020.06.24.2 BETA SEB FFB (3).JPG SEB FFB (4).JPG FFB (4) FIELD STRENGTH of HARMONICS and SPURIOUS RADIATED EMISSIONS photo PSA-ESCI 2020.04.03.0 photos PSA-ESCI 2020.04.03.0 SEB FFB (1).JPG SEB FFB (2).JPG FFB (2) FIELD STRENGTH OF FUNDAMENTAL photo PSA-ESCI 2020.04.03.0 photos PSA-ESCI 2020.04.03.0 SEB FFB (3).JPG SEB FFB (4).JPG FFB (4) FIELD STRENGTH OF FUNDAMENTAL XMit 2020.03.25.0 IMG_0527.JPG IMG_0528.JPG DUTY CYCLE XMit 2020.03.25.0 IMG_0529.JPG DUTY CYCLE