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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.
Page | 14
Instructions for Use
Rev. 4
CanarE System
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