Use Instructions

Page |
15
Analysis and conversion to Canary Medical Gait Parameters for viewing on the Physician
and Patient Dashboards.
The following information describes the Base Station systems.
4.4.1. OR Base Station System
The OR Base Station subsystem is intended to send and receive data to and from the CTE implant
over a wireless communication interface. Data sent to the CTE implant from the OR Base Station
activates the CTE implant on the day of surgery. Data received from the CTE implant is uploaded
to the Canary-supplied computer in the operating room environment and onto the Canary Cloud
platform when connected to it through the Internet.
The surgical team uses the OR Base Station during the TKA surgery to register the patient and
activate the CTE implant so that it will begin collecting data after the patient’s surgery. The
hardware functions are “limited to assisting the following software functions: electronic transfer,
storage, or display of medical device data.”
The OR Base Station subsystem includes an OR software application for perioperative interaction
with the CTE intended to wake up the CTE, prior to implant with no risk to the patient. Following
activation, the firmware embedded in the CTE manages the data collection control aspects of the
implant. The OR software application is a PC-based local application intended for use by
Healthcare Professionals. The OR software application will be loaded onto a Canary Medical
laptop that will be provided to healthcare facilities that offer the CTE implant to their patients.
The OR software application performs the following functions:
Pre-implant – The OR application allows a self-test of the CTE as well as a sensor check to be
performed prior to implantation. The OR Application displays if successful tests have been run
in the last 24 hours (in which case the user can elect to not run the tests). If the user elects to
perform the tests, the OR application displays information to the user if these tests passed
successfully. The CTE implant kinematic data collection is still inactive at this point and is not
needed for performing the self-test.
In OR – The OR application allows self-tests to be performed on the CTE during and after the
implantation procedure. During or after CTE implantation is completed, the OR App can be used
to activate the CTE to initiate its kinematic data collection algorithm via the OR Base Station unit.
Post-implant – After the surgery is completed, the OR application can be used to scan the
barcodes on the labels of the CTE and other implanted TKA components; these data can also be
manually entered. This information can then be submitted by the OR App to the Canary Cloud.
This action associates the particular CTE with the previously registered patient in the Canary
Physician Instructions for Use
DRAFT