Table of Contents
Summary of Contents for Canary CanarE System
- Page 1 CanarE System CanarE™ System Instructions for Use Read this Instructions for Use carefully. If you have additional questions after reading this Instructions for Use, contact Canary Medical. Page | 1 Instructions for Use Rev. 4...
- Page 2 CanarE System How to Contact Canary Medical Customer Assistance Phone: 1-833-722-6279 or 1-833-7CANARY E-mail: support@canarymedical.com Internet: www.canarymedical.com Mail: Canary Medical USA LLC 2710 Loker Ave. West Suite 350 Carlsbad, CA 92010 Page | 2 Instructions for Use Rev. 4...
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Page 3: Table Of Contents
CanarE System TABLE OF CONTENTS Overview ........................... 4 References ........................7 Terms and Definitions ...................... 8 Intended Use ........................10 Contraindications, Warnings, and Precautions ............11 5.1. Contraindications ......................11 5.2. Warnings ........................11 5.3. Precautions .........................11 Packaging Content ......................12 Device Description ......................14 7.1. -
Page 4: Overview
• Clinic PC and Application The CanarE System is intended to provide objective kinematic data on a patient’s knee function before or after total knee arthroplasty (TKA). This system produces kinematic data intended as an adjunct to the standard of care as directed by the physician. It also collects the patient kinematic data from its internal motion sensors (identical to the CTE implant). - Page 5 CanarE System Figure 2: System Component Interfaces Page | 5 Instructions for Use Rev. 4...
- Page 6 CanarE System Figure 3: Clinic Cart Page | 6 Instructions for Use Rev. 4...
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Page 7: References
CanarE System References Table 1. Reference Documents Reference Title K01-CTE-300004 CTE with CHIRP System – Physician IFU K01-HBS-300003 CTE with CHIRP System – Patient IFU K02-CBS-300003 Clinic Base Station System – IFU K03-CRT-800000 Clinic Cart – Assembly Document Page | 7 Instructions for Use Rev. -
Page 8: Terms And Definitions
TKA surgical procedure. Canary Cloud Data Management Platform. The Cloud is a software environment that collects information from a variety of data sources. The information is then stored in a secure encrypted database for CDMP retrieval and processing. - Page 9 CanarE System Term Definition Software Total Knee Arthroplasty Universal Serial Bus Page | 9 Instructions for Use Rev. 4...
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Page 10: Intended Use
CanarE System Intended Use The CanarE is intended as an accessory for use with the Clinic Base Station System to provide objective kinematic data from an external wearable device to assist the clinician before or after a patient’s TKA surgical procedure. The kinematic data is intended as an adjunct to standard of care and physiological parameter measurement tools applied or used by the physician during patient monitoring and treatment. -
Page 11: Contraindications, Warnings, And Precautions
WARNING: Do not use the CanarE or accessories if they are damaged. Exposure to internal electronics within the device components could result in electric shock. WARNING: The CanarE System components should not be tampered with or modified in any way. Exposure to internal electronics may result in harm. -
Page 12: Packaging Content
CanarE System Packaging Content The CanarE System package contains the following items: • CanarE (wearable device) CanarE Charger with power cord and plug adapter • • CanarE Straps (separate package) – not shown Clinic Cart (separate package) – not shown •... - Page 13 CanarE System NOTE: Connect only items that are specified as part of the device / system. Additional equipment connected to medical electrical equipment must comply with the respective IEC or ISO standards. Furthermore, all configurations shall comply with the requirements for medical electrical systems (see clause 16 of edition 3 of IEC 60601-1, respectively).
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Page 14: Device Description
The CanarE System allows preoperative patient evaluation to establish a patient’s baseline data prior to receiving a CTE implant. Alternatively, the CanarE System may be used postoperatively on patients who receive a non-Canary implant where objective, functional mobility data is desired. - Page 15 CanarE System The Cart has power strips and power cables to provide power to the Clinic Laptop, Clinic Base Station, and CanarE Charger. The Clinic Cart also has wheel brakes to hold its position when needed and can transport all components around the clinic environment.
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Page 16: Directions For Use
CanarE System Directions for Use The following information describes the use of the CanarE System in sequential order. This information is provided from an HCP’s perspective. It is intended to provide directions for HCPs (including surgeons, surgeon’s staff, physicians, and nurses) in using the CanarE System. It is also intended to inform HCPs about their patient’s role in the use of the system to support... -
Page 17: Attaching The Canare To A Patient
CanarE System Table 4: CanarE LED Charging Status LED Status Definition Constant Green Charging: CanarE battery status is between 85% -100% charged Flashing Green Charging: CanarE battery status is between 40-84% charged Flashing Orange Charging: CanarE battery status is between 20-39% charged... - Page 18 CanarE System Figure 9: CanarE Placement on Tibia Use the straps provided or self-adhesive tape to securely attach the CanarE to the patient. a. If using the CanarE Straps, follow the steps below as shown in Figure 10: i. Loop one end of the strap through the lateral slot of the CanarE and secure the Velcro to the strap.
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Page 19: Performing Data Collections With The Canare
CanarE System Figure 10: Attaching CanarE with Strap b. If using the self-adhesive tape: i. Wrap the self-adhesive tape around the CanarE and patient’s knee multiple times with overlap to secure the CanarE. NOTE: When pulling the self-adhesive tape tight to secure the CanarE to the patient, the CanarE may slightly shift on the patient’s knee. -
Page 20: Using The Clinic Cart
CanarE System Table 5: CanarE LED Active Status LED Status Definition Constant Green Active: CanarE battery status is between 85% -100% charged Flashing Green Active: CanarE battery status is between 40-84% charged Flashing Orange Active: CanarE battery status is between 20-39% charged... -
Page 21: Canare Placement And Power Supply
CanarE System Figure 11: Clinic Cart with Clinic Base Station 8.4.3. CanarE Placement and Power Supply The CanarE, CanarE Charger, and Straps can be stored in the Clinic Cart drawer as illustrated in Figure 12. Figure 12: CanarE and CanarE Charger Placement... -
Page 22: Data Security And Patient Privacy
The Canary Medical Cloud Platform is designed for assuring HIPAA compliance. When the Clinic App is set up, a secure connection is established between the Clinic App and the Canary Cloud and is in effect for all communication thereafter. The Clinic Base Station decrypts messages and data from the CanarE, adds the serial number of the CanarE package, and then encrypts the unprocessed data before transmitting that data to the Cloud. -
Page 23: Component Maintenance
CanarE System 10. Component Maintenance 10.1. Updating a CanarE This section describes how to update the CanarE. The Clinic App and Clinic Base Station are required to update the CanarE. Launch and log into the Clinic App as described in the Clinic Base Station System IFU. -
Page 24: Clinic Cart Maintenance
However, lint or dust may get into the USB ports or the ports may become degraded and interfere with power to or communications with the CanarE or accessories. Do not attempt to clean or repair the USB ports. Instead, contact Canary Medical for a replacement. 10.3. Clinic Cart Maintenance Before first use and after periods of non-use, check the Clinic Cart for proper operation. -
Page 25: Service Life
CanarE System 11. Service Life The CanarE and accessories are intended to last for 3 years and can be replaced if they become non-operational. Page | 25 Instructions for Use Rev. 4... -
Page 26: Servicing
If a CanarE or accessory is not working properly or even changes in performance, please see Section 14 for troubleshooting and potential solutions to the problem. If the issue cannot be fixed, please call Canary Medical for instructions on how to further troubleshoot the problem or return the unit for replacement. -
Page 27: Disposal
CanarE System 13. Disposal Contact your local authorities to determine the proper disposal method of CanarE units and accessories as electronics waste or return them to Canary Medical. Page | 27 Instructions for Use Rev. 4... -
Page 28: Troubleshooting
CanarE System 14. Troubleshooting Table 6 lists steps that will generally solve issues encountered on the CanarE System. If the problem persists, contact Canary Medical Support. Table 6: CanarE System Troubleshooting Issue Troubleshooting Steps Make sure the CanarE Charger is connected to power. -
Page 29: Adverse Events
Fault (self-test failure) • Mode of Operation (Continuous): The HCP uses the CanarE System before, during, and after on demand clinic data collection. It is used to perform on demand data collection, as well as transport and store components. The CanarE System consists of a CanarE, CanarE Charger, and Clinic Cart. - Page 30 CanarE System Clinic Cart Specification Safe Working Load 28.7 kg Dimensions 777 x 643 x 524 mm Power Source 120V 60 Hz Class I Temperature: 15°C to 30° C Recommended Operating Conditions Relative Humidity: 10% to 90% (non-condensing) Atmospheric Pressure: 70 kPa – 106 kPa Storage: -18°...
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Page 31: Electrical Safety And Standard
CanarE System 16. Electrical Safety and Standard 16.1. Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The transmitter is intended for use in an electromagnetic environment as specified in Table 8. The customer or the user of the transmitter should make sure that it is used in such an environment. -
Page 32: Electromagnetic Emissions
CanarE System the pins using the rounded tip finger of the ESD generator. The exception is that the only connector pins that are tested are those that can be contacted or touched, under conditions of INTENDED USE, by the standard test finger illustrated in Figure 6 of the general standard, applied in a bent or straight position. -
Page 33: Warranty
CanarE System 17. Warranty Canary Medical (or such other legal entity as may be referred to as manufacturer on the labeling of this device, hereinafter “Canary Medical”) warrants the CanarE (hereinafter “Product”) to the original purchaser of the Product against defects in material and workmanship for a period of one (1) year from the date the Product is purchased. -
Page 34: Patents And Trademarks
CanarE System 18. Patents and Trademarks All trademarks are the exclusive property of Canary Medical and its Subsidiaries with the exception of CaviWipes® which is the property of its respective owner. Page | 34 Instructions for Use Rev. 4... -
Page 35: Symbols Glossary
CanarE System 19. Symbols Glossary Designation Title of the Symbol Meaning Number and Title Symbol in the of Standard Standard Canary Medical Logo ISO 7000 —3082 The name of the Graphical symbols for device’s Manufacturer use on equipment -- manufacturer... - Page 36 CanarE System Designation Title of the Symbol Meaning Number and Title Symbol in the of Standard Standard ISO 14708-1, clause 9.6 and 11.6 Implants for surgery — Active implantable medical Date the device was devices — Part 1: Date of Manufacture...
- Page 37 CanarE System Designation Title of the Symbol Meaning Number and Title Symbol in the of Standard Standard See Table 12 for information to be additional supplied information. ISO 15223-1 clause 5.3.8 Medical devices — Transport and Symbols to be used with...
- Page 38 CanarE System Designation Title of the Symbol Meaning Number and Title Symbol in the of Standard Standard Protected from touch by fingers and objects greater than IEC 60601-1, (IEC 60529) clause 6.3; 12 millimeters, and Degree of protection Table D.3...
- Page 39 Customer Service: 1-833-722-6279 or 1-833-7CANARY This material is intended for health care professionals. Distribution to any other recipient is prohibited. © 2020-2022 Canary Medical . All rights reserved. PN. K03-CNE-300005 Rev. 4 Page | 39 Instructions for Use Rev. 4...