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.
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.
CanarE System TABLE OF CONTENTS 1. Overview ........................................................................................................................... 4 2. References ........................................................................................................................ 7 3. Terms and Definitions ...................................................................................................... 8 4. Intended Use...................................................
CanarE System 1. Overview Before using this device, carefully read all instructions for use. The CanarE System includes three components as shown in Figure 1 below: • CanarE (wearable device) with Straps (not shown) • CanarE Charger • Clinic Cart Figure 1.
CanarE System Figure 2: System Component Interfaces Page | 5 Instructions for Use Rev.
CanarE System Figure 3: Clinic Cart Page | 6 Instructions for Use Rev.
CanarE System 2. 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.
CanarE System 3. Terms and Definitions Table 2: Terms and Definitions Term Definition Base Station Device used to communicate and collect data from the CTE implant or CanarE device CanarE™ An external wearable device that provides objective kinematic data to assist the clinician before and after a patient’s TKA surgical procedure. CDMP (“Cloud”) CHIRP™ Canary Cloud Data Management Platform. The Cloud is a software environment that collects information from a variety of data sources.
CanarE System Term Definition SW Software TKA Total Knee Arthroplasty USB Universal Serial Bus Page | 9 Instructions for Use Rev.
CanarE System 4. 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.
CanarE System 5. 5.1. Contraindications, Warnings, and Precautions Contraindications None known. 5.2. Warnings WARNING: Use only cables and accessories supplied by Canary Medical. Use of other cables and accessories may result in increased emissions or decreased immunity of the CanarE System. WARNING: Plug CanarE and accessories into standard 110V-120VAC wall outlets only. Attempting to connect these items to a non-standard electricity source could cause injury or cause damage to the equipment.
CanarE System 6. 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 Table 3 lists all the CanarE components and their model or catalogue numbers.
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).
CanarE System 7. Device Description The CanarE System combines physical components, electronics, software, and user interfaces to collect, store, and transmit patient kinematic data for physician review. Table 3 lists the CanarE System components and interfaces. All physical components of the CanarE System, except the straps, are reusable and supplied non-sterile. The cleaning and disinfecting instructions for components can be found in Section 10.2.
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. Figure 5: Clinic Cart The Clinic Cart, intact skin contacting, material consists of high-density polyethylene (HDPE) and glass fiber reinforced nylon. Page | 15 Instructions for Use Rev.
CanarE System 8. 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 patients’ understanding of their health care needs. 8.1.
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 Constant Orange Charging: CanarE battery status is between 0-19% charged 8.2.
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. ii. Wrap the other end of the strap around the patient’s leg then through the other lateral slot of the CanarE. iii. Pull the strap tight and use the Velcro to secure it.
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. Make sure the CanarE placement on the patient’s knee has not changed. If the CanarE has shifted, readjust its position to the correct location.
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 Constant Orange Active: CanarE battery status is between 0-19% charged Remove the CanarE from the patient’s knee when testing is complete. Dispose of the Straps or self-adhesive tape.
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 | 21 Instructions for Use Rev.
CanarE System 9. Data Security and Patient Privacy All communication between the CanarE and the Clinic Base Station employs a unique communication protocol, with each CanarE having a unique Radio ID that is assigned to it in manufacturing. A Clinic Base Station can communicate with only one CanarE at a time using this Radio ID. The communication between the Clinic Base Station and CanarE device is also encrypted with the unique encryption key assigned during the manufacture of the CanarE.
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. NOTE: Internet connection is required to download CanarE updates. Connect the Clinic Base Station to the Clinic Laptop and power it on as described in the Clinic Base Station System IFU.
CanarE System 3. Allow to remain visibly wet for 2 minutes, per CaviWipes manufacturer recommendation. 4. Allow to air dry at ambient temperature. The following solutions have been tested for safely cleaning the CanarE, CanarE Charger, and Clinic Cart. Wipe the devices after each use with a soft cloth dampened with one of these solutions: 1. 1:10 Bleach Solution 2. 1:10 Mild Detergent Solution 3. Ammonia Solution (RTU) 4. 70% Isopropyl Alcohol 5. 0.5% Hydrogen Peroxide 6.
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.
CanarE System 12. 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 | 26 Instructions for Use Rev.
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.
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. LED is not on while CanarE is charging LED on the CanarE is yellow Clinic Cart is not providing power Page | 28 If using the Clinic Cart power source, make sure the Cart is connected to a power outlet.
CanarE System 15. Component Specifications CanarE and Charger Table 7: CanarE System Specifications Specification Weight CanarE: 50 g CanarE Charger: < 280 g Dimensions CanarE: 25.6 x 53.3 x 87.1 mm CanarE Charger: 30.9 x 91.8 x 128.
CanarE System Clinic Cart Specification Safe Working Load 28.
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.
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. Capacitive coupling shall be used.
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.
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.
CanarE System 19. Symbols Glossary Symbol Meaning Designation Number and Title of Standard Title of the Symbol in the Standard Canary Medical Logo The name of the device’s manufacturer The catalogue or order number assigned to the device by the manufacturer The unique serial number assigned to the device by the manufacturer Computer-tocomputer exchange of business documents in standardized formats Indicates the need for the user to consult the instructions for use.
CanarE System Symbol Meaning Date the device was manufactured Directs the user to read the instructions for use For prescription use only Instructs the transporter of the device package to keep the device package dry Instructs the transporter of the device package to protect the device package from sunlight Transport and storage temperature limits Page | 36 Designation Number and Title of Standard Title of the Symbol in the Standard ISO 14708-1, clause 9.6 and 11.
CanarE System Symbol Meaning See Table 12 for additional information. Designation Number and Title of Standard information to be supplied Title of the Symbol in the Standard ISO 15223-1 clause 5.3.8 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied Humidity limitation ISO 15223-1 clause 5.2.8 ISO 11607-1 clause 10 Do not use if package is damaged ISO 15223-1 clause 5.4.
CanarE System Symbol Meaning Protected from touch by fingers and objects greater than 12 millimeters, and Protected from water spray less than 15 degrees from vertical.
CanarE System Manufactured for: Canary Medical USA LLC 2710 Loker Ave. West Suite 350 Carlsbad, CA 92010 www.canarymedical.com 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.
