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
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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
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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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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

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Figure 3: Clinic Cart

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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

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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

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

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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.

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5. Contraindications, Warnings, and Precautions
5.1. 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.
WARNING: Do not stack the CanarE and accessories or use them adjacent to other electrical
equipment.
WARNING: Do not immerse the CanarE or accessories in water. Electric shock could result.
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.
5.3. Precautions
CAUTION:Make sure that the system components are not visibly damaged prior to use.
CAUTION:Do not use electrical converters with the CanarE or accessories. They have not
been tested for this application.
CAUTION:Only use cleaning or disinfection solutions listed within this IFU. Other solutions
have not been tested for this application.
CAUTION:Contact your local authorities to determine the proper disposal method of CanarE
Units and accessories as electronics waste or return them to Canary Medical.
CAUTION:Assess patient fall risk relevant to tests available with the Clinic Base Station
System prior to performing the selected test(s) with the CanarE.

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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.
Figure 4: CanarE System Components Within Packaging
Table 3: CanarE System Components
Model or Catalogue Number Description
43-5570-007-14 CanarE
43-5570-007-15 CanarE Charging Cradle
43-5570-007-16 CanarE Straps
43-5570-008-14 Clinic Cart

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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). Anybody connecting additional equipment to medical electrical equipment
configures a medical system and is therefore responsible for ensuring that the system
complies with the requirements for medical electrical systems.
NOTE: Always position equipment so the mains power connection is accessible.

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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. The CanarE straps are single-use,
disposable that are provided non-sterile.
The HCP will attach the CanarE to the patient, then use the Clinic Base Station to perform data
collection from the CanarE while the patient performs a selected test. After testing is complete,
the Clinic Base Station retrieves the data collected from the CanarE to be processed and
reviewed in the Clinic App.
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. Lastly, the CanarE may also be used postoperatively on patients with a CTE implant if
desired.
7.1. The CanarE and Straps
The CanarE is a physical component that the HCP attaches to the patient’s knee with the
provided elastic, nylon, and Velcro Straps or with self-adhesive tape. The CanarE is an external
wearable device intended to mimic a CTE implant, using similar software and electronics
embedded within the device to collect the patient’s functional movement and gait parameter
information. The CanarE collects, stores, and transmits data when queried by the Clinic Base
Station. The collected data from the CanarE is processed by the Clinic Base Station System for
review.
The CanarE and Straps, intact skin contacting, material consists of polycarbonate and
acrylonitrile / butadiene styrene (PC/ABS), Cycoloy, polyester, nylon, and Velcro.
7.2. The CanarE Charger
The CanarE Charger is a wireless charging device that recharges the CanarE internal battery. It
is designed with a cavity to hold the CanarE while charging. The charger includes a power cord
to connect to a power source.
The CanarE Charger, intact skin contacting, material consists of polycarbonate and acrylonitrile
/ butadiene styrene (PC/ABS), Cycoloy and polyvinyl chloride (PVC).
7.3. The Clinic Cart
The Clinic Cart is designed to store, provide a power source, and transport the components of
the Clinic Base Station and CanarE Systems. Figure 5 shows an image of the Clinic Cart. It has
a flat top surface for the Clinic Laptop and provides a working surface, a holder for the Clinic
Base Station, and a drawer to store CanarE devices, a CanarE Charger, and CanarE Straps.

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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.

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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. Getting Started: CanarE
Remove all components from their packaging. See Figure 4.
NOTE: Straps are provided separately.
Make sure that there are no damaged components. If damage is observed do not
use.
Connect the CanarE Charger to power with the supplied power cord and plug
adapter. A USB power supply may also be used without the plug adapter.
NOTE: The Clinic Cart contains a power source for the CanarE Charger.
Place the CanarE flat surface down (logo face up) into the CanarE Charger holder as
shown in Figure 6 and Figure 7. The CanarE contains an LED that will indicate its
charge status while charging, as defined in Table 4.
NOTE: See troubleshooting steps in Section 14 if the CanarE LED is a constant
yellow.
When ready to use the CanarE, remove it from the Charger. The CanarE
automatically powers on.
Figure 6: CanarE Charger
Figure 7: CanarE Charger with CanarE
Charging Indicator

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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. Attaching the CanarE to a Patient
With the patient sitting or standing, palpate the knee to locate the patient’s left or
right tibial tuberosity according to the Test Plan created with the Clinic Base Station
System (Left Knee or Right Knee selected from the Clinic App Patient Test Plan).
NOTE: The CanarE is an external wearable device intended to mimic a CTE implant
by positioning it in the approximate location of a CTE implant as shown in Figure 8.
Figure 8: CanarE Placement Positioned in the Approximate Location of a CTE Implant
Place the CanarE directly onto the patient’s knee with the superior surface of the
CanarE located on the inferior most aspect of the tibial tuberosity as shown in Figure
9.
NOTE: Do NOT place the CanarE over patient clothing. This may cause an
unintended shift of the CanarE during testing, which will affect test result data.
Align the CanarE alignment mark with the axis of the tibia by palpating the patient’s
tibia inferior of the CanarE. Attach the CanarE as shown in Figure 9.

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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.
NOTE: When pulling the strap tight to secure the CanarE to the patient, the
CanarE may slightly shift on the patient’s leg. Make sure that placement of the
CanarE on the patient’s leg has not changed. If the CanarE has shifted,
readjust its position to the correct location. If the position is not corrected, this
may affect the CanarE data collection.
NOTE: Make sure the CanarE and strap are not too tight by asking the
patient.
iv. Check placement and adjust if needed.

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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. If the position is not
corrected, this may affect the CanarE data collection.
Instruct the patient to walk with the CanarE attached to their knee. Observe and
make sure the CanarE is secure and is not shifting position while the patient walks.
Adjust the CanarE as needed.
NOTE: Ask the patient if the CanarE feels uncomfortable or too loose and make
adjustments.
8.3. Performing Data Collections with the CanarE
Enter the CanarE serial number, found on the patient’s device label, into the Clinic
App (see the Clinic Base Station System IFU).
Follow the Clinic Base Station System IFU to perform data collection using the
CanarE.
During data collection, the CanarE LED will indicate when the CanarE is active. The
LED status is defined in Table 5.
NOTE: See troubleshooting steps in Section 14 if the CanarE LED is a constant
yellow.

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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.
CAUTION Do not reuse the Straps; dispose after use.
8.4. Using the Clinic Cart
Assemble the Clinic Cart following the instructions provided in its packaging (K03-
CRT-800000).
Connect the Cart’s power cord to a standard outlet power supply.
NOTE: The Cart’s power supplies will not be active unless the Cart’s power cord is
connected to standard outlet power supply.
The Cart can transport components by releasing the wheel’s brakes, and then
pushing it to the desired location. Once in the desired location, set the brakes to
keep the Cart from moving.
8.4.1. Clinic Laptop Placement and Power Supply
Place the Clinic Laptop in the desired location on the Clinic Cart’s top flat service.
Connect the Clinic Laptop to the Laptop Power Supply as illustrated in Figure 11.
8.4.2. Clinic Base Station Placement and Power Supply
Place the Clinic Base Station in the holder on the Clinic Cart’s top flat service as
illustrated in Figure 11.
Connect the Clinic Base Station to the charging cord as illustrated in Figure 11.
NOTE: The Clinic Base Station will be connected to the Clinic Laptop for use if both
are connected to a power source on the Clinic Cart and powered on.