Use Instructions

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10. PRINCIPLES OF OPERATION

This section provides information describing how the Canary CTE with CHIRP System collects,

stores, transmits, and processes the kinematic data generated by the CTE implant.

The CTE implant performs five different active functions:

1) low resolution event marking (step counting and activity detection),

2) medium resolution acquisition events (for gait analysis),

3) high resolution acquisition events (for gait analysis),

4) data storage to memory, and

5) wireless data transfer to a base station.

When not performing one of these active functions, the CTE remains in a state of ultra-low power

deep sleep. Prior to implantation, the CTE remains constantly in a state of deep sleep until

“woken up” the day of implantation.

After implantation, these active functions are specified to occur for programmed periods of time

during what is defined as a “sampling day.”. A “sampling day” is a 24-hour period in which the

implant spends between 12 to 18 hours in Low-Resolution mode, 30 seconds performing medium

resolution acquisition events, and 3 seconds performing high resolution acquisition events along

with brief periods of data storage and wireless data transfer. On days that are not “sampling

days”, the implant stays in deep sleep for the entire 24 hours to maintain the CTE implant’s real

time clock and non-volatile memory.

After implantation, the CTE implant’s useful life is determined by the battery’s internal self-

discharge rate, power consumption as the implant moves through its active functions on

sampling days, and the number of “sampling days.” The CTE implant is powered by a “primary”

battery so it does not require recharging or any other maintenance during the operational life of

the CTE implant.

10.1. Collection, Storage, and Transmission of the CTE Data

The CTE implant will start collecting data on post-operative day 2, and thereafter, data will be

transmitted to the Cloud on sampling days via the connection to the patient’s Home Base Station.

Physician Instructions for Use

DRAFT