Canary CanarE System User manual

CanarE System
Page | 1 Instructions for Use
Rev. 4
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.

CanarE System
Page | 2 Instructions for Use
Rev. 4
How to Contact Canary Medical
Customer Assistance Phone: [phone] or 1-833-7CANARY
E-mail: [e-mail]
Internet: www.canarymedical.com
Mail: Canary Medical USA LLC
2710 Loker Ave. West
Suite 350
Carlsbad, CA 92010

CanarE System
Page | 3 Instructions for Use
Rev. 4
TABLE OF CONTENTS
1. Overview ........................................................................................................................... 4
2. References........................................................................................................................ 7
3. Terms and Definitions...................................................................................................... 8
4. Intended Use....................................................................................................................10
5. Contraindications, Warnings, and Precautions ............................................................11
5.1. Contraindications ........................................................................................................11
5.2. Warnings ....................................................................................................................11
5.3. Precautions.................................................................................................................11
6. Packaging Content..........................................................................................................12
7. Device Description ..........................................................................................................14
7.1. The CanarE and Straps ..............................................................................................14
7.2. The CanarE Charger...................................................................................................14
7.3. The Clinic Cart ............................................................................................................14
8. Directions for Use ...........................................................................................................16
8.1. Getting Started: CanarE..............................................................................................16
8.2. Attaching the CanarE to a Patient ...............................................................................17
8.3. Performing Data Collections with the CanarE .............................................................19
8.4. Using the Clinic Cart ...................................................................................................20
8.4.1. Clinic Laptop Placement and Power Supply.........................................................20
8.4.2. Clinic Base Station Placement and Power Supply ...............................................20
8.4.3. CanarE Placement and Power Supply .................................................................21
9. Data Security and Patient Privacy..................................................................................22
10. Component Maintenance................................................................................................23
10.1. Updating a CanarE .....................................................................................................23
10.2. CanarE, CanarE Charger, and Clinic Cart Cleaning....................................................23
10.3. Clinic Cart Maintenance..............................................................................................24
11. Service Life ......................................................................................................................25
12. Servicing..........................................................................................................................26
13. Disposal ...........................................................................................................................27
14. Troubleshooting ..............................................................................................................28
15. Adverse Events ...............................................................................................................29
16. Electrical Safety and Standard .......................................................................................31
16.1. Guidance and Manufacturer’s Declaration – Electromagnetic Immunity......................31
16.2. Electromagnetic Immunity Specifications ....................................................................31
16.3. Electromagnetic Emissions .........................................................................................32
17. Warranty ..........................................................................................................................33
18. Patents and Trademarks.................................................................................................34
19. Symbols Glossary ...........................................................................................................35

CanarE System
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Rev. 4
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 Components
It is intended to be used in conjunction with the Clinic Base Station System, specifically with the
following subsystems:
•Clinic Base Station
•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). When queried by
the Clinic Base Station, it transmits the patient kinematic data to the Clinic Base Station. The
Clinic Base Station, in turn, uploads the data to the Clinic Laptop when connected. Next, that
data is uploaded to the Canary Cloud Data Management Platform (“Cloud”). Figure 2 provides a
schematic overview of the system’s components and interfaces.

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Figure 2: System Component Interfaces

CanarE System
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Figure 3: Clinic Cart

CanarE System
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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

CanarE System
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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”)
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
retrieval and processing. The Cloud also contains the CMCEP
software module that converts the unprocessed kinematic data from
the CTE or CanarE to clinical parameters to be viewed in the Clinic
App
CHIRP™ Canary Health Implanted Reporting Processor
CMCEP
Canary Medical Clinic Evaluation Parameters.
Parameters that summarize the kinematic data collected from a
patient’s CTE implant or CanarE device for a selected test. The
parameters are calculated in the Cloud and displayed in the Clinic
App for physicians to review.
CTE Canturio™ Tibial Extension
EM Electromagnetic
ESD Electrostatic Discharge
FW Firmware
HCP Health Care Professional
IFU Instructions for Use
IMU Inertial Measurement Unit
PC Personal Computer
ROM Range of Motion
RTU Ready-To-Use

CanarE System
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Term Definition
SW Software
TKA Total Knee Arthroplasty
USB Universal Serial Bus

CanarE System
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Rev. 4
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.
The CanarE is not intended for diagnostic or therapeutic uses or in conjunction with
rehabilitation or therapeutic exercise.