| all | frequencies |
|
|
|
|
exhibits | applications |
|---|---|---|---|---|---|---|---|
| manuals | photo | label | |||||
| app s | submitted / available | |||||||
|---|---|---|---|---|---|---|---|---|
| 1 |
|
User Manual | Users Manual | 25.25 KiB | July 30 2021 | |||
| 1 |
|
User Manual II | Users Manual | 1.00 MiB | July 30 2021 | |||
| 1 |
|
External Photos | External Photos | 225.74 KiB | July 30 2021 / January 26 2022 | delayed release | ||
| 1 |
|
Label | ID Label/Location Info | 3.26 MiB | July 30 2021 | |||
| 1 |
|
Confidentiality Letter | Cover Letter(s) | 501.90 KiB | July 30 2021 | |||
| 1 |
|
RF Exposure report | RF Exposure Info | 273.07 KiB | July 30 2021 | |||
| 1 |
|
Test Report | Test Report | 1.53 MiB | July 30 2021 | |||
| 1 |
|
Test Setup photos | Test Setup Photos | 1.43 MiB | July 30 2021 / January 26 2022 | delayed release |
| 1 | User Manual | Users Manual | 25.25 KiB | July 30 2021 |
Manufactured for:Canary Medical, LLC.2710 Loker Ave. WestSuite 350Carlsbad, CA 92010www.canarymedical.comE-mail: support@canarymedical.comCustomer Assistance: 1-800-123-9876PN. K01-HBS-300003, Rev2Page | 46US Federal Communications Commission (FCC)•FCC ID: 2AYAJ-BS1•This transmitter is authorized by rule under the Medical Device Radiocommunication Service (in part 95 of the FCC Rules) and must not cause harmful interference to stations operating in the 400.150–406.000 MHz band in the Meteorological Aids (i.e., transmitters and receivers used to communicate weather data), the Meteorological Satellite, or the Earth Exploration Satellite Services and must accept interference that may be caused by such stations, including interference that may cause undesired operation. This transmitter shall be used only in accordance with the FCC Rules governing the Medical Device Radiocommunication Service. Analog and digital voice communications are prohibited. Although this transmitter has been approved by the Federal Communications Commission, there is no guarantee that it will not receive interference or that any particular transmission from this transmitter will be free from interference. This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment.•This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. •IMPORTANT: Changes or modifications to this product not authorized by Canary Medical could void the FCC Certification and negate your authority to operate this product.
| 1 | User Manual II | Users Manual | 1.00 MiB | July 30 2021 |
Physician Instructions for Use
Canary Tibial Extension
with
Canary Health Implanted Reporting Processor
(CHIRP) System
Caution:
Federal law (USA) restricts this device to sale by or on the order of a physician.
Canary Medical, Inc.
TABLE OF CONTENTS
1. OVERVIEW OF THE CANARY TIBIAL EXTENSION WITH CHIRP SYSTEM.................... 5
2. ADDITIONAL REFERENCED DOCUMENTS ................................................................. 6
3. TERMS AND ACRONYMS .......................................................................................... 7
4. DEVICE SYSTEM DESCRIPTION ................................................................................. 9
4.1. The Canary Tibial Extension (CTE).......................................................................... 10
4.2. CTE Template ......................................................................................................... 12
4.3. CTE with CHIRP System Surgical Instrumentation ................................................. 12
4.3.1.
4.3.2.
4.3.3.
4.3.4.
Impaction Sleeve ............................................................................................ 12
Canary Tibia Cut Guide (5 Degree – L/R) ........................................................ 13
Canary Drill Bit ................................................................................................ 13
CTE Provisional ............................................................................................... 14
4.4. Base Station Systems ............................................................................................. 14
4.4.1. OR Base Station System .................................................................................. 15
4.4.2. Home Base Station System ............................................................................. 16
4.4.3.
The Canary Medical Cloud Data Management Platform (Cloud) ................... 17
4.5. Physician Portal ...................................................................................................... 17
4.6. Patient Dashboard ................................................................................................. 20
5.
INTENDED USE ....................................................................................................... 22
5.1. Intended Use .......................................................................................................... 22
5.2. Indications for Use ................................................................................................. 22
5.3. Users and Component Interfaces .......................................................................... 22
Physician Instructions for Use
DRAFT
Page | 1
6.
7.
10.1.
10.2.
LIMITATIONS .......................................................................................................... 26
CONTRAINDICATIONS ............................................................................................ 26
8. MRI Compatibility .................................................................................................. 27
9. GENERAL WARNINGS AND PRECAUTIONS............................................................. 27
9.1. CTE ......................................................................................................................... 27
9.2. Surgical and Home Base Stations and Accessories (including Bar Code Scanners,
Laptops, and cables) ...................................................................................................... 27
10. PRINCIPLES OF OPERATION ................................................................................... 28
Collection, Storage, and Transmission of the CTE Data .................................. 28
Canary Medical Gait Parameters Data Characteristics ................................... 29
11. DIRECTIONS FOR USE ............................................................................................. 30
11.1.
Surgeon’s Office Patient Account Setup ......................................................... 31
11.1.1.
Orthopedic Surgeon .................................................................................... 31
11.1.2.
Surgeon’s Office Staff .................................................................................. 31
11.2.
Patient Registration and Account Setup ......................................................... 33
11.2.1.
Patient ......................................................................................................... 33
11.3.
Home Base Station System Setup................................................................... 33
11.3.1.
Patient ......................................................................................................... 33
11.4.
Day of Surgery ................................................................................................ 34
11.4.1.
Preoperative: CTE Implant Self-Test and Sensor Check ............................. 34
11.4.2.
Intraoperative: Tibia Resection, Preparation, and Trialing ........................ 36
11.4.3.
Intraoperative: Activate the CTE implant .................................................. 37
Physician Instructions for Use
DRAFT
Page | 2
Intraoperative: Connection of Canary CTE to Zimmer Biomet Tibial
11.4.4.
Baseplate and Implantation ......................................................................................... 37
11.4.5.
the Patient 39
Postoperative: Link the CTE implant and Knee Prosthesis Components to
11.5.
HCP.................................................................................................................. 39
11.5.1.
Patient ......................................................................................................... 39
12. ADVERSE EVENTS ................................................................................................... 40
13. COMPATIBILITY WITH OTHER DEVICES .................................................................. 40
14. COMPONENT SPECIFICATIONS .............................................................................. 41
15. DATA SECURITY AND PATIENT PRIVACY ................................................................ 48
16. COMPONENT MAINTENANCE ................................................................................ 48
CTE .................................................................................................................. 48
Base Station Units and Accessories ................................................................ 49
SOFTWARE MAINTENANCE ............................................................................ 49
17. SERVICE LIFE ........................................................................................................... 49
CTE .................................................................................................................. 49
Base Station Units and Accessories ................................................................ 49
18. SERVICING .............................................................................................................. 50
CTE .................................................................................................................. 50
Base Station Units and Accessories ................................................................ 50
19. DISPOSAL................................................................................................................ 51
CTE .................................................................................................................. 51
Canary Medical Surgical Instrumentation ...................................................... 51
Physician Instructions for Use
DRAFT
16.1.
16.2.
16.3.
17.1.
17.2.
18.1.
18.2.
19.1.
19.2.
Page | 3
19.3.
Base Station Units and Accessories ................................................................ 51
20. WARRANTY............................................................................................................. 51
21. PATENTS AND TRADEMARKS ................................................................................. 51
APPENDIX 1 – SYMBOLS GLOSSARY .............................................................................. 53
APPENDIX 2 – DEFINITIONS ........................................................................................... 58
APPENDIX 3 – TROUBLESHOOTING ............................................................................... 60
Physician Instructions for Use
DRAFT
Page | 4
1. OVERVIEW OF THE CANARY TIBIAL EXTENSION WITH CHIRP SYSTEM
Before using this device, carefully read all instructions for use.
The Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) is a
tibial extension implant containing electronics and software. Using internal motion sensors (3-
D accelerometers and 3-D gyroscopes), the CTE collects kinematic data pertaining to a patient’s
gait and activity level following total knee arthroplasty (TKA). The kinematic data produced by
the CTE implant is intended as an adjunct to the TKA post-procedure standard of care, as directed
by the physician. The CTE implant is assembled with the Zimmer Biomet Persona® tibial
baseplate to form a total knee prosthesis. In addition to its data collection capabilities, the CTE
implant provides additional stability to the complete knee prosthesis in the same manner as a
traditional tibial extension.
The CTE with CHIRP System uses external OR and Home “Base Station” units to query the CTE
implant (which has an internal radio and antenna) and upload the data collected by the CTE
implant to the Canary Cloud data management platform (the Cloud). Information from the
implant is processed by the system’s Canary Medical Gait Parameter (CMGP) software into
clinically relevant metrics.
To qualify to receive the CTE with CHIRP System, the Patient must meet the following
requirements in addition to any requirements for TKA surgery as determined by the patient’s
HCPs:
1. The Patient’s anatomy must be capable of accepting the Zimmer Biomet Persona Tibia
Baseplate with Canary Tibial Extension construct sizing. This assessment will be
conducted pre-operatively by the HCP using a CTE Template supplied by Canary Medical.
2. The patient must have access to a computer with a USB connection to set up their Home
Base Station.
3. The Patient must have wireless internet in their domicile.
The CTE with CHIRP System technology package ultimately allows patients and their Health Care
Professionals (HCPs) to view the patient’s functional activity data which is collected and
processed by the system. Patients and HCPs view the information on HCP and Patient
“Dashboards” on the Canary Medical website, which is accessible through the use of the Internet.
Figure 1 shows a schematic of the CTE with CHIRP System.
Physician Instructions for Use
DRAFT
Page | 5
Figure 1: Canary Medical CTE with CHIRP System
2. ADDITIONAL REFERENCED DOCUMENTS
Table 1 lists additional documents relevant to the CTE with CHIRP System which are referenced
in this Instructions for Use (IFU).
Document Title
Location
Table 1
Document
Number
Canary Medical Surgical Technique
K01-CTE-300005
Printed/electronically available
Patient Manual
K01-HBS-300003
www.canarymedical.com
Printed Document Shipped with
Home Base Station
www.canarymedical.com
Patient Quick Start Guide – Home
Base Station Setup
K01-HBS-300006
Printed Document Shipped with
Home Base Station
www.canarymedical.com
Physician Instructions for Use
DRAFT
Page | 6
Document Title
Location
Document
Number
Patient Quick Start Guide –Setting
Up Your Patient Account
K01-HBS-300005
Printed. Provided to patient at
surgeon’s office.
OR Quick Start Guide – OR Base
Station Setup
K01-ORBS-
300003
Printed Document Shipped with OR
Base Station
www.canarymedical.com
www.canarymedical.com
Zimmer Biomet Persona Knee
Surgical Technique
97-5026-001-00
Zimmer Biomet Instructions for Use 87-6204-042-99
3. TERMS AND ACRONYMS
Table 2 lists terms and acronyms used in this document.
Table 2: Terms and Acronyms
Term
Meaning
Circulating Nurse
Canary Health Implanted Reporting Processor
Canary Medical Cloud Based Data Management Platform
Canary Medical Gait Parameter
Canary Tibial Extension
Ethylene Oxide
Health Care Professional
Hertz
Physician Instructions for Use
DRAFT
CN
CHIRP
Cloud
CMGP
CTE
EtO
HCP
Hz
Page | 7
PMMA Cement
Polymethylmethacrylate Bone Cement
Term
Meaning
Instructions for Use
Intramedullary
Inertial Measurement Unit
Microcontroller Unit
Operating Room
Personal Computer
Personal Protective Equipment
Radio Frequency
Restriction of Hazardous Substances
Range of Motion
Ready to Use
Total Knee Arthroplasty
Universal Serial Bus
IFU
IM
IMU
MCU
OR
PC
PPE
RF
RoHS
ROM
RTU
TKA
USB
Page | 8
Physician Instructions for Use
DRAFT
4. DEVICE SYSTEM DESCRIPTION
The Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) is a
system that combines physical components, electronics, software, and user interfaces to collect,
store, analyze, transmit, and display patient data for use by both physicians and patients. Table
3 lists the components and interfaces of the CTE with CHIRP System.
Table 3: CTE with CHIRP System Components
Component or
Interface
Description
CTE Implant
14mm (D) x 58mm (H)
Tibial Extension with internal electronics and
software which allows it to collect kinematic
data in addition to providing stability to the
patient’s knee prosthesis
CTE 14mm x 58mm X-
Ray Template
Used to preoperatively determine if the
patient’s anatomy is appropriate for a CTE
implant
Surgical
Instrumentation
CTE Impaction Sleeve
Model Number or
Catalogue
Number
43-5570-058-14
43-5570-004-14
43-5399-001-14
5 deg Left Tibial Resection Cutting Guide
43-5399-051-05
5 deg Right Tibial Resection Cutting Guide
43-5399-052-05
Drill Bit
43-5399-058-14
CTE Provisional
43-5571-058-14
OR Base Station System OR Base Station unit
Dedicated Laptop PC
43-5570-002-14
43-5570-003-14
Physician Instructions for Use
DRAFT
Page | 9
Component or
Interface
Description
Model Number or
Catalogue
Number
Canary OR Application
TBD
Home Base Station
System
Home Base Station Unit
43-5570-001-14
Barcode Scanner
AC-900001
USB Power and Data Cables
TBD
USB Data and Power Cables
Power Adapter
Base Station Setup Tool (software
application)
AC-900002
AC-900003
TBD
Canary Cloud Data
Management Platform
(Cloud)
Manages and processes patient data that can
be accessed through the patient or physician
portal
Canary Medical Gait
Parameter Software
Facilitates outputs to the Physician
Dashboard and Patient Dashboard user
interfaces. The dashboards allow physicians
and patients, respectively, to view selected
gait and activity metrics collected from the
CTE and processed by the Cloud
NOTE: Patients need their own USB-enabled laptop or PC with at least one USB port and a
wireless Internet connection to connect to their Home Base Station.
NOTE: Both physicians and patients can access their respective dashboards via an Internet
browser.
4.1. The Canary Tibial Extension (CTE)
The Canary Tibial Extension is a physical implant component that is attached by the orthopedic
surgeon or scrub tech to the Zimmer Biomet Persona® tibial baseplate to form the patient’s knee
Physician Instructions for Use
DRAFT
Page | 10
prosthesis. Like a traditional tibial extension, the CTE provides additional stability to the
replacement knee joint. In addition, the software and electronics embedded within the CTE
collect the patient’s functional movement and gait parameter information post-surgery. The CTE
is an implantable device that is provided sterile to the customer. It is sterilized via Ethylene Oxide
(EtO) and is packed in sterile packaging inside a sealed, tamper-proof outer box. For more
information on the Zimmer Biomet Persona® tibial baseplate, refer to the Zimmer Biomet
Persona Knee Surgical Technique (97-5026-001-00) and Instructions for Use (87-6204-042-99) .
Figure 2 is a representation of the CTE implant.
Figure 2: CTE Implant
Figure 3 is a representation of the assembled Canary Medical CTE and Zimmer Biomet Persona®
tibial baseplate devices.
Figure 3: Zimmer Biomet Persona® Tibial Baseplate with Canary Tibial Extension
Physician Instructions for Use
DRAFT
Page | 11
4.2. CTE Template
The CTE Template is a surgical instrument used to assist the surgeon during preoperative
planning. The CTE Template will be used to assess the patient anatomy for the Zimmer Biomet
Persona Tibia Baseplate with Canary Tibial Extension construct sizing.
4.3. CTE with CHIRP System Surgical Instrumentation
All CTE with CHIRP System Surgical Instrumentation is supplied non-sterile in an instrument tray.
The cleaning and sterilization instructions for surgical instruments are found in the Canary
Medical Instrument Care Instructions for Use, document # K01-INT-300019. The surgical
instrumentation for the CTE with CHIRP System includes the Impaction Sleeve, Canary Tibia Cut
Guides (L/R), Canary Drill Bit, and CTE Provisional.
4.3.1.
Impaction Sleeve
The Impaction Sleeve is a single-use (provided non-sterile, see Section 4.3), disposable surgical
instrument used to assist in attaching the CTE implant to the Zimmer Biomet Persona® Tibial
Plate. The Impaction Sleeve protects the implant’s electronic components from impaction forces
that occur during assembly. Figure 4 is a graphical representation of the CTE Impaction Sleeve.
WARNING: The Impaction Sleeve is single-use only. It must be discarded as medical waste after
use.
Figure 4: CTE Impaction Sleeve
Physician Instructions for Use
DRAFT
Page | 12
4.3.2. Canary Tibia Cut Guide (5 Degree – L/R)
The Canary Medical Tibia Resection Cutting Guide (left or right option) is used for tibia
preparation when implanting a Persona Primary Knee with a Canary Tibial Extension (CTE)
Implant. Figure 5 shows the Canary Medical Tibia Resection Cutting Guides.
Left Cutting
Guide
Right Cutting
Guide
Figure 5: Canary Tibia Resection Cutting Guides
4.3.3. Canary Drill Bit
The Canary Drill Bit is used to create the cavity in the patient’s tibial IM canal to fit the CTE implant
and cement mantle. Figure 6 shows the Canary Drill Bit.
Figure 6: Canary Drill Bit
Physician Instructions for Use
DRAFT
Page | 13
4.3.4. CTE Provisional
The Persona Tibial Keel length ranges from 23.4 mm to 40 mm. The Canary Tibial Extension adds
58 mm to the length of the tibial keel nominally when assembled. This CTE Provisional is used to
ensure the fit of the CTE implant within the patient’s anatomy prior to CTE implantation. Figure
7 shows the CTE Provisional.
4.4. Base Station Systems
Figure 7: CTE Provisional
The CTE with CHIRP Base Station subsystems are composed of external base station units and
associated software that facilitate communication with the CTE implant. There are two Base
Station system configurations: an OR Base Station system for use by the Surgical team, and a
Home Base Station system for use by the Patient. The Base Station units query a specified CTE
implant to transmit data to and from that CTE implant and to the Canary Cloud Data Management
Platform for:
Activation of a CTE implant during surgical procedure
Linking of a CTE implant with a patient
Physician Instructions for Use
DRAFT
Page | 14
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
Page | 15
Cloud. The action of associating the CTE with the patient also enables the home base station to
recognize the CTE when the patient returns home after surgery, thus enabling upload of
kinematic data from the CTE to the Canary Cloud without patient intervention. The OR Base
Station System consists of an OR Base Station unit, dedicated laptop PC loaded with the Canary
software application, barcode scanner, and USB cables. Figure 8 shows a schematic of the OR
Base Station System.
Figure 8: OR Base Station System
4.4.2. Home Base Station System
The Home Base Station System is located at the patient’s home, where it is set up by the
patient prior to the date of surgery. The Home Base Station System provides an interface for
communication with the patient’s CTE implant. It consists of a Home Base Station unit, the
patient’s USB-enabled personal computer, the patient’s wireless Internet connection, and a
USB power and data cable. After TKA surgery, the Home Base Station unit begins collecting the
patient’s gait and activity information from the CTE. The Home Base Station unit transmits the
data to the Cloud, and has the capability to store the data for up to forty five days.
Figure 9 shows a schematic of the Home Base Station System communication.
Physician Instructions for Use
DRAFT
Page | 16
Knee Implant
Collects Data
Base Station
Transfers Data
Cloud Processes
Data
Figure 9: Base Station Communication
Dashboards
Display Data to
Doctor and
Patient
4.4.3. The Canary Medical Cloud Data Management Platform (Cloud)
The Canary Cloud Data Management Platform (“Cloud”) allows users to access it through a
browser-based web application. The Cloud subsystem is intended to receive and store all of the
healthcare professional and patient data for pre-operative, day of operation and post-operation
activities, including patient kinematic data from the CTE implant. The post-operation patient
kinematic data will be used by the surgeons, nurses and patients to monitor the patient post-TKA
as an adjunct to the standard of care.
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 CMGP software module that converts the unprocessed kinematic data
from the CTE to gait parameters for reporting to the Physician Dashboard and Patient Dashboard
Users.
4.5. Physician Portal
The Physician Portal is located on the Canary Medical website (www.canarymedical.com) and is
accessible by the patient’s health care providers (HCPs) via an Internet browser. HCPs can log
into the portal with a username and password to view patient information and CMGPs generated
by the patient’s CTE implant. CMGPs are displayed on the Physician Dashboard, and include:
Walking Speed (meters/second)
Step Count
Tibia Range of Motion (degrees)
Functional Knee Range of Motion (degrees)
Stride length (meters)
Distance (kilometers)
Cadence (steps/minute)
Physician Instructions for Use
DRAFT
Page | 17
The CHIRP system is not intended to provide real time data like a smart watch or smart phone.
Rather, it collects data over the course of a day, analyzes it while the patient is asleep, and
presents the previous day’s data for HCP and patient review the following day.
The CTE implant has the ability to store 30 day of data. Therefore, if the patient’s Home Base
Station connection is temporarily lost or they are traveling for less than 30 days without a Home
Base Station, the full amount of data will be uploaded to the Canary Cloud once a connection is
made to the Home Base Station. If there is no connection for periods greater than 30 days, new
data will over-write the oldest data until a connection to the patient’s Home Base Station and
the Canary Cloud is made.
The CTE implant has been programed to collect data using the following schedule.
Time Period
Sampling
Day 0 (surgery) to Day 1
No sampling
Day 2 to Day 365
Daily
Year 2
30 consecutive Days/Quarter
Years 3 and beyond
30 consecutive days commencing on the
anniversary of the patient’s your surgery date
When the CTE is not sampling, it is in a low power mode to conserve battery power. When
viewing a patient’s data, if no values are present during a particular day or period of time, it
simply means during this period the CTE was not collecting data per its program.
Figure 10 shows a screenshot of the Patient Chart on the Physician Dashboard.
Physician Instructions for Use
DRAFT
Page | 18
Figure 10: Screenshot of Patient Chart on Physician Dashboard
Physician Instructions for Use
DRAFT
Page | 19
4.6. Patient Dashboard
The Patient Dashboard is located on the Canary Medical website and is accessible by the patient
via his/her Internet browser. Patients can view selected CMGPs generated by their CTE implant,
including gait information and activity level. Information available to patients includes:
Walking Speed (feet/second)
Step Count
Range of Motion (degrees)
Stride length (feet)
Distance (miles)
Cadence (steps/minute)
Figure 11 shows a screenshot of the Patient Dashboard.
Physician Instructions for Use
DRAFT
Page | 20
Figure 11: Screenshot of Patient Dashboard
Physician Instructions for Use
DRAFT
Page | 21
5.
INTENDED USE
5.1. Intended Use
The CTE with CHIRP System is intended to provide objective kinematic data while providing
additional stability afforded by a traditional tibial extension. The implanted medical device is
used to assist the patient and the physician during a patient’s TKA post-surgical care. The
kinematic data is intended as an adjunct to standard of care and physiological parameter
measurement tools applied or utilized by the physician during the course of patient monitoring
and treatment post-surgery.
5.2. Indications for Use
The Canary Tibial Extension implant is indicated for use with the Zimmer Persona® Personalized
Knee System for total knee arthroplasty (TKA) in patients with severe knee pain and disabilities
due to:
Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis
Collagen disorders, and/or avascular necrosis of the femoral condyle
Post-traumatic loss of joint configuration, particularly when there is patellofemoral
erosion, dysfunction or prior patellectomy
Moderate valgus, varus, or flexion deformities
The salvage of previously failed surgical attempts or for a knee in which satisfactory
stability in flexion cannot be obtained at the time of surgery.
The Canary Tibial Extension with CHIRP System may be used in any instance where additional,
objective, kinematic data on total knee replacement function is beneficial to the implant care
process as determined by the physician.
This device is intended to be used with cemented knee constructs.
5.3. Users and Component Interfaces
The CTE with CHIRP System is intended to provide objective kinematic data on the patient’s
activity level and total knee arthroplasty (TKA) function. The OR Base Station System is used to
set up, test, and activate the CTE Implant before implantation. It is also used to associate the
CTE to the specific patient by recording serial number information for the CTE Implant and
associated Zimmer Biomet Persona® Personalized Knee System components. The OR Base
Station System transmits these data to the Canary Cloud Data Management Platform linked to
the Patient’s account.
Physician Instructions for Use
DRAFT
Page | 22
The implanted CTE collects data from internal motion sensors, and when queried by a Home Base
Station, transmits the CTE motion sensor data to the associated Home Base Station System. The
Home Base Station System then uploads the data to the Canary Cloud Data Management
Platform via the patient’s Internet connection.
Users of the System are the Patient with the CTE with CHIRP System and their designated Health
Care Professional (HCP) with access to the Patient’s CTE data.
Physician Instructions for Use
DRAFT
Page | 23
i
i
s
i
s
e
h
t
s
o
r
p
t
e
m
o
B
r
e
m
m
Z
/
E
T
C
d
e
b
m
e
s
s
a
e
h
t
t
n
a
p
m
l
l
i
y
l
l
a
c
i
g
r
u
S
l
e
t
a
p
e
s
a
b
®
a
n
o
s
r
e
P
r
e
m
m
Z
e
h
t
o
t
E
T
C
e
h
t
h
c
a
t
t
A
i
n
o
i
t
a
r
a
p
e
r
p
d
n
a
n
o
i
t
c
e
s
e
r
l
i
a
b
T
i
A
K
T
g
n
i
r
u
d
e
c
i
v
e
d
t
n
a
p
m
l
i
E
T
C
f
o
n
o
i
t
a
v
i
t
c
a
d
n
a
n
o
i
t
a
t
n
a
p
m
l
i
,
y
l
b
m
e
s
s
a
–
m
a
e
t
l
a
c
i
g
r
u
S
m
a
e
T
l
a
c
i
g
r
u
S
.
t
n
a
p
m
l
i
w
e
n
o
t
e
t
a
m
i
l
c
c
a
d
n
a
y
r
e
g
r
u
s
r
e
t
f
a
e
t
a
t
i
l
i
b
a
h
e
R
–
t
n
e
i
t
a
P
,
t
n
e
i
t
a
P
t
n
a
p
m
l
I
)
E
T
C
(
n
o
i
s
n
e
t
x
E
l
i
i
a
b
T
y
r
a
n
a
C
n
o
i
t
a
t
S
e
s
a
B
R
O
d
n
a
e
r
a
w
t
f
o
s
p
p
A
R
O
e
h
t
h
t
i
w
E
T
C
e
h
t
e
t
a
v
i
t
c
A
m
a
e
T
l
a
c
i
g
r
u
S
l
t
n
a
p
m
I
)
E
T
C
(
n
o
i
s
n
e
t
x
E
l
i
i
a
b
T
y
r
a
n
a
C
s
n
o
i
t
c
a
r
e
t
n
I
s
r
e
s
U
e
c
a
f
r
e
t
n
I
r
e
s
U
/
t
n
e
n
o
p
m
o
C
s
t
n
e
n
o
p
m
o
C
m
e
t
s
y
S
P
R
H
C
h
t
i
I
w
E
T
C
:
4
e
b
a
T
l
.
t
n
e
n
o
p
m
o
c
h
c
a
e
r
o
f
r
e
s
u
d
e
d
n
e
t
n
i
e
h
t
d
n
a
m
e
t
s
y
s
e
h
t
f
o
s
t
n
e
n
o
p
m
o
c
e
h
t
s
t
s
i
l
l
4
e
b
a
T
e
r
a
w
t
f
o
s
p
p
A
R
O
e
h
t
h
t
i
w
E
T
C
e
h
t
e
t
a
v
i
t
c
A
n
o
i
t
a
m
r
o
f
n
i
t
n
e
i
t
a
p
h
t
i
w
N
S
E
T
C
k
n
i
L
E
T
C
n
o
k
c
e
h
c
r
o
s
n
e
s
d
n
a
t
s
e
t
-
f
l
e
s
m
r
o
f
r
e
P
m
a
e
T
l
a
c
i
g
r
u
S
n
o
i
t
c
e
s
e
R
l
i
i
a
b
T
t
f
e
L
g
e
d
5
l
e
v
e
e
S
n
o
i
t
c
a
p
m
I
i
e
d
u
G
g
n
i
t
t
u
C
n
o
i
t
c
e
s
e
R
l
i
i
a
b
T
t
h
g
R
g
e
d
5
i
d
n
a
y
l
b
m
e
s
s
a
d
e
z
i
l
a
i
c
e
p
s
y
r
a
n
a
C
s
t
n
e
n
o
p
m
o
c
n
o
i
t
r
e
s
n
i
i
e
d
u
G
g
n
i
t
t
u
C
t
i
B
l
l
i
r
D
l
i
a
b
T
i
l
a
n
o
i
s
i
v
o
r
P
E
T
C
C
P
p
o
t
p
a
L
d
e
t
a
c
i
d
e
D
n
o
i
t
a
c
i
l
p
p
A
e
r
a
w
t
f
o
S
t
i
n
U
n
o
i
t
a
t
S
e
s
a
B
m
e
t
s
y
S
n
o
i
t
a
t
S
e
s
a
B
R
O
l
s
e
b
a
C
a
t
a
D
d
n
a
r
e
w
o
P
r
e
n
n
a
c
S
e
d
o
C
r
a
B
o
o
o
o
o
e
s
U
r
o
f
s
n
o
i
t
c
u
r
t
s
n
I
n
a
i
c
i
s
y
h
P
T
F
A
R
D
4
2
|
e
g
a
P
y
r
a
n
a
C
d
n
a
,
t
i
n
U
n
o
i
t
a
t
S
e
s
a
B
,
E
T
C
e
h
t
n
e
e
w
t
e
b
n
o
i
t
a
c
i
n
u
m
m
o
c
p
u
t
e
s
o
t
n
o
i
t
a
c
i
l
p
p
a
l
o
o
T
p
u
t
e
S
n
o
i
t
a
t
S
e
s
a
B
d
a
o
n
w
o
D
l
t
e
n
r
e
t
n
I
d
u
o
C
l
s
s
e
e
r
i
l
w
e
m
o
h
d
n
a
e
c
i
v
e
d
g
n
i
t
u
p
m
o
c
l
a
n
o
s
r
e
p
o
t
t
c
e
n
n
o
C
e
m
o
h
s
’
t
n
e
i
t
a
P
n
i
s
t
n
e
n
o
p
m
o
c
n
o
i
t
a
t
S
e
s
a
B
p
u
t
e
S
t
n
e
i
t
a
P
e
r
a
w
t
f
o
S
l
o
o
T
p
u
t
e
S
n
o
i
t
a
t
S
e
s
a
B
l
s
e
b
a
C
a
t
a
D
d
n
a
r
e
w
o
P
n
o
i
t
a
c
i
l
p
p
A
m
e
t
s
y
S
n
o
i
t
a
t
S
e
s
a
B
e
m
o
H
t
i
n
U
n
o
i
t
a
t
S
e
s
a
B
s
n
o
i
t
c
a
r
e
t
n
I
s
r
e
s
U
e
c
a
f
r
e
t
n
I
r
e
s
U
/
t
n
e
n
o
p
m
o
C
l
e
v
e
l
y
t
i
v
i
t
c
a
d
n
a
s
c
i
t
y
l
a
n
a
t
i
a
g
s
’
t
n
e
i
t
a
p
w
e
i
v
e
R
d
r
a
o
b
h
s
a
D
n
a
i
c
i
s
y
h
P
t
i
a
G
l
a
c
i
d
e
M
y
r
a
n
a
C
,
y
t
i
r
u
c
e
s
d
n
a
e
c
n
a
n
e
t
n
a
M
n
o
i
t
a
m
r
o
f
n
i
I
f
f
a
t
S
l
a
c
i
d
e
M
e
r
a
w
t
f
o
S
r
e
t
e
m
a
r
a
P
t
n
e
i
t
a
P
d
n
a
n
a
i
c
i
s
y
h
P
,
n
o
i
t
a
t
S
e
s
a
B
e
m
o
H
,
n
o
i
t
a
t
S
e
s
a
B
R
O
l
m
r
o
f
t
a
P
t
n
e
m
e
g
a
n
a
M
a
t
a
D
d
u
o
C
l
l
e
v
e
l
y
t
i
v
i
t
c
a
d
n
a
n
o
i
t
a
m
r
o
f
n
i
t
i
a
g
s
’
t
n
e
i
t
a
p
w
e
i
v
e
R
d
r
a
o
b
h
s
a
D
t
n
e
i
t
a
P
,
m
a
e
t
l
a
c
i
g
r
u
s
e
r
a
c
y
r
a
m
i
r
p
,
)
P
C
P
(
r
e
d
i
v
o
r
p
l
a
c
i
n
i
l
c
s
’
P
C
P
r
e
h
t
o
,
f
f
a
t
s
,
n
o
e
g
r
u
S
r
o
/
d
n
a
y
l
i
m
a
f
r
e
v
i
g
e
r
a
c
y
r
a
n
a
C
,
t
n
e
i
t
a
P
y
l
b
i
s
s
o
p
s
’
t
n
e
i
t
a
p
s
P
C
H
e
s
U
r
o
f
s
n
o
i
t
c
u
r
t
s
n
I
n
a
i
c
i
s
y
h
P
T
F
A
R
D
5
2
|
e
g
a
P
6. LIMITATIONS
The patient needs to have sufficient intramedullary space to accommodate the increased length
of the CTE implant in order to avoid cortical perforation. Before choosing the CTE implant for a
patient, assess if the patient’s anatomy is appropriate by using the Canary CTE implant X-Ray
Templates.
The patient must have access to a computer with USB connection and home wireless Internet
access in order for their data to be collected, stored, and transmitted by the CTE with CHIRP
System.
7. CONTRAINDICATIONS
The Canary Tibial Extension (CTE) is contraindicated for use in patients who are undergoing
procedures or treatments at or in the proximity of the CTE using ionizing radiation, as these could
damage the CTE.
After a patient receives TKA surgery with the Canary CTE with CHIRP System and Zimmer
Biomet Persona® Personalized Knee System, make the patient aware that electrical currents
conducted or induced into the body from an external source are contraindicated for patients with
an active implantable medical device.
Before performing TKA on any patient, consider the following contraindications.
The Zimmer Biomet Persona® Personalized Knee System is contraindicated for use in patients
who have:
Previous history of infection in the affected joint and/or other local/systemic infection
that may affect the prosthetic joint
Insufficient bone stock on femoral or tibial surfaces
Skeletal immaturity
Neuropathic arthropathy
Osteoporosis or any loss of musculature or neuromuscular disease that compromises the
affected limb
A stable, painless arthrodesis in a satisfactory functional position
Severe instability secondary to the absence of collateral ligament integrity
Total Knee Arthroplasty is contraindicated in patients who have rheumatoid arthritis (RA)
accompanied by an ulcer of the skin or a history of recurrent breakdown of the skin because their
risk of postoperative infection is greater. RA patients using steroids may also have increased risk
of infection. Late infections in RA patients have been reported 24+ months postoperative.
Physician Instructions for Use
DRAFT
Page | 26
8. MRI Compatibility
The CTE implant is expected to be MRI conditional. (Pending completion of MRI safety testing).
WARNING: Pending completion of MRI safety testing.
9. GENERAL WARNINGS AND PRECAUTIONS
9.1. CTE
WARNING: Do not use the CTE implant or other sterile packaged components if the package is
opened or damaged. This could mean the device is no longer sterile. Use of non-sterile implants
or components might result in patient infection, injury, or death.
CAUTION: Do not apply electrocautery directly to or across the CTE implant as this could cause
damage to the device.
WARNING: The CTE implant may heat up during an MRI procedure causing pain or tissue
damage.
WARNING: Do not apply ionizing radiation to or near the CTE implant as this could damage the
implant.
9.2. Surgical and Home Base Stations and Accessories (including Bar Code Scanners, Laptops,
and cables)
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 CTE with CHIRP
System.
WARNING: Plug Base Stations and accessories into standard 110V 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 Base Stations and accessories or use them adjacent to other
electrical equipment.
WARNING: Do not immerse the Base Station or accessories in water. Electric shock could result.
CAUTION: Do not use electrical converters with the Base Stations or accessories. They have not
been tested for this application.
Physician Instructions for Use
DRAFT
Page | 27
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
Page | 28
The CTE has the capability to store up to 30 days of data in memory. If the data contained in the
CTE’s memory cannot be transmitted to the Cloud due to connectivity issues with a Base Station
and the implant has reached its memory limit, new data will overwrite the oldest data first. In
this scenario, data will be lost. The Home Base Station can store up to 45 days of transmitted
data if it is not able to connect to the Cloud but is still able to communicate with the implant
locally.
10.2. Canary Medical Gait Parameters Data Characteristics
The CTE collects raw sensor data that is transferred through a Base Station to the Cloud where it
is processed to generate the Canary Medical Gait Parameters listed in Table 5. These gait
parameters summarize activity metrics for the clinician after a patient undergoes TKA surgery.
The intent of the data is to provide information which is accessible to both the patient and their
clinician and to facilitate the delivery of healthcare to the patient by the clinician.
Table 5: Canary Medical Gait Parameters
Parameter
Description
Units
Walking Speed
Mean sagittal plane distance walked per unit
time. Directly calculated from cadence and
stride length for each gait cycle.
meters
second/s
per
Cadence
Mean steps per minute. Derived from two
consecutive peak angular velocities.
steps per minute
Stride length
Mean distance traveled during one gait cycle.
meters
Knee ROM
Tibia ROM
Mean sagittal plane functional knee joint range
of motion. Difference between maximum and
minimum knee joint flexion.
degrees
Mean sagittal plane range of motion of the tibia
with respect to the floor. Difference between
the minimum and maximum tibia to floor angle.
degrees
Step Count
Number of steps taken during a Sampling Day.
steps
Physician Instructions for Use
DRAFT
Page | 29
Parameter
Description
Units
Distance
Distance traveled. Calculated from step count
and stride length
meters
Cadence, Stride, Tibia ROM, and Knee ROM are statistical values calculated on the collected
sampling day data. The range of motion measurements are schematically illustrated in Figure 12
he angle calculated based on
a combination of tabular hip and femur reference data and the Tibia ROM data.
–
11. DIRECTIONS FOR USE
The following information describes the use of the CTE with CHIRP System in chronological order
of the system’s use. The process starts with the Orthopedic Surgeon/Patient consultation where
the patient decides to receive TKA with the CTE and CHIRP System. It follows through to the post-
operative period when the CTE begins collecting data, and HCPs and Patients can view selected
metrics on their respective Dashboards.
Physician Instructions for Use
DRAFT
Page | 30
This information is provided from a user perspective. It is intended to provide directions for HCPs
(including surgeons, surgeon’s staff, physicians, and nurses) in the use of the CTE with CHIRP
System. It is also intended to inform HCPs about their patients’ role in the use of the system to
support patients’ understanding of their health care needs.
11.1.
Surgeon’s Office Patient Account Setup
11.1.1. Orthopedic Surgeon
Meet with the patient and present the risks and benefits of TKA surgery and the use of the CTE
with CHIRP System. Assess if the patient’s anatomy is appropriate for using the Canary CTE
implant X-Ray Templates.
Ensure the patient has access to a computer with USB connectivity and a home Wireless Internet
connection..
WARNING: The patient needs to have sufficient intramedullary space to accommodate the
increased length of the CTE implant in order to avoid cortical perforation.
When the patient decides on TKA with the CTE and CHIRP System, direct the office staff to
onboard the patient using the Physician Portal.
11.1.2. Surgeon’s Office Staff
1. Create a new patient account by logging into the Canary Physician account. After logging
in, you will see the “Doctor Dashboard” screen in Figure 13. Click on “Patient List.”
Figure 13
Physician Instructions for Use
DRAFT
Page | 31
2. Figure 14 shows a screenshot of the Patient List screen. Click on “Create.”
Figure 14: Patient List Screen
3. Use the “Create Patient” screen (Figure 15) to enter the patient’s information (name,
DOB, email, etc.). Click “Submit.”
Figure 15: Create Patient Screen
Physician Instructions for Use
DRAFT
Page | 32
4. Instruct the patient to watch for an email with a link and directions on how to register
and set up a patient account.
5. Provide the patient with a copy of the Quick Start Guide, Setting Up Your Patient Account,
document # K01-HBS-300005
11.2. Patient Registration and Account Setup
11.2.1. Patient
The patient receives the email and uses the Quick Start Guide, Setting Up Your Patient Account,
document # K01-HBS-300005, to register and set up a patient account. The following are the
steps in this process.
1. The Canary Cloud emails the patient a link to create a patient account.
2. The patient clicks the link and creates a patient account.
a. The patient creates the password for their Canary Patient account and logs in.
b. The patient provides consent for receiving the CTE and data collection by the CTE.
c. The patient accepts the Terms and Conditions for use of the CTE with CHIRP
System
d. The patient enters their personal information
3. Upon successful registration, Canary Medical ships the Home Base Station equipment to
the patient.
11.3. Home Base Station System Setup
11.3.1. Patient
The patient receives the Home Base Station package, which includes a Quick Start Guide, Setting
Up Your Home Base Station Patient Manual. The patient sets up the Home Base Station System
using the Quick Start Guide (document # K01-HBS-300006) and Patient Manual (document # K01-
HBS-300003). The steps to set up the Home Base Station System are summarized below.
1. Receives the shipment of Home Base Station components
Physician Instructions for Use
DRAFT
The Patient:
Page | 33
2. Opens the package, inspects the equipment, and identifies the enclosed Quick Start
Guide and Patient Manual.
3. Turns on the patient’s personal computer with USB connection, opens a web browser,
navigates to the Canary website, and logs into the patient’s account, which was
created previously.
4. Follows the instructions in the Quick Start Guide and Patient Manual to set up the
Base Station.
11.4. Day of Surgery
The following provides instructions on how to set up, test, and activate the CTE implant. It also
tells you how to link the CTE implant and associated Zimmer knee components to the specific
patient.
This information is a summary. For a complete description of this process, including example
screenshots, refer to the Canary Medical Surgical Technique, document # K01-CTE-300005,
provided at www.canarymedical.com.
11.4.1. Preoperative: CTE Implant Self-Test and Sensor Check
NOTE: The OR App will not function and you will not be able to log in without first connecting
the OR Base Station to the Laptop.
1. Turn on the Canary Laptop and ensure it has a Wi-Fi connection
2. Gather a CTE implant, the OR Base Station Unit, Bar Code Scanner, and USB data and power
cables.
a. Check the expiration date on the CTE package to ensure the implant is not expired.
WARNING: To avoid potential patient injury, do not use the CTE implant if it is expired.
NOTE: Do not open the CTE package at this time.
3. Set up the OR Base Station system in or near the OR but outside the sterile field, using the
steps below:
a. Place the Base Station stand on a flat surface. Place the Base Station into the stand
as shown in Figure 16. Insert the provided screw through the groove in the stand into
the Base Station. Tighten the screw with a screw driver.
Physician Instructions for Use
DRAFT
Page | 34
Base Station
Screw
Stand
Figure 16: Base Station in Stand – Rear View
b. Connect the USB cable to the OR Base Station on one end and the Laptop PC on the
other, as shown in Figures 17 and 18.
Figure 17
Figure 18
c. Connect the Barcode Scanner to the Laptop.
d. Plug the Laptop into a power outlet (if needed).
e. Turn on the Laptop. The Canary Operating Room Application (OR App) will launch
automatically.
Physician Instructions for Use
DRAFT
Page | 35
f. Ensure the OR Base Station and Laptop are connected. This is indicated by the green
“Base Station” icon at the top right of the Laptop screen.
g. Ensure an Internet connection has been established and the OR App is connected to
the Internet. This is indicated by the green “Internet” icon at the top right of the
screen. If the OR App is not connected to the Internet, check the time of last sync. If
it has been some time since this has been done, move to a location and attempt to
connect to the Internet.
h. Click on the Canary logo in the center of the screen.
i. Enter your authorized Username and Password and click the “Login” button.
j. On the Main Menu screen, under “Preoperative,” click on “Setup Implant.”
k. Enter or scan the CTE serial number from the implant package and click “OK.”
l.
The Base Station initiates communication with the CTE implant. Click “OK” when this
process is finished.
m. Click on Self-Test.
n. Click on Sensor Check.
o. When the Self-Test and Sensor Check are successful (shown by the “implant status”
indicators on the screen), the CTE implant is ready to be used for the patient’s TKA
surgery. If the Self-Test and Sensor Check have been run successfully within the last
24 hours, the status will reflect that, and the user can elect to not repeat these tests.
11.4.2. Intraoperative: Tibia Resection, Preparation, and Trialing
The tibia resection and preparation is done similarly to the Zimmer Biomet Persona® technique.
However, the CTE with CHIRP System surgical technique deviates from the Persona Knee
Surgical Technique in order to properly place the CTE implant.
Refer to both the Canary Medical CTE with CHIRP System and Zimmer Biomet Persona Knee IFUs
and Surgical Techniques for the detailed technique steps. See Section # 2 of this IFU for
document references.
The steps to complete the tibia resection and preparation are summarized below.
Physician Instructions for Use
DRAFT
Page | 36
CAUTION: Perform the tibia resection using the Canary Medical Tibia Resection Cutting Guide.
The Zimmer Biomet Persona Tibia Resection Cutting Guides have not been tested for use with
the Canary Tibial Extension (CTE).
1. Use the Persona instrumentation to properly align and size the tibia plate
2. Create a pilot hole using the Zimmer Biomet Drill Guide and Persona Tibial Drill Bit. Then
use the Canary Medical Drill Bit and Drill Guide to create a cavity in the IM canal for the
CTE implant and cement mantle.
3. Broach the tibia using the Persona instrumentation to create a cavity for the Persona Tibia
Plate.
4. Assemble the CTE Provisional to the Persona Tibia Plate Provisional and insert the
provisional construct into the prepared tibia to assess the fit of the construct. Confirm
the final implant sizing.
11.4.3. Intraoperative: Activate the CTE implant
After the CTE implant has been introduced into the sterile field, and before assembly with the
Persona tibial plate, activate the CTE implant using the OR PC Application and OR Base Station.
1. Go to the Main Menu screen.
2. Under “Intraoperative,” click on “Activate Implant.”
3. Click in the text box and enter or scan the CTE Serial Number. Click “OK.”
4. Click “Activate.”
5. The Activation Status on the screen will change from “Not Activated” to “Activated.”
11.4.4. Intraoperative: Connection of Canary CTE to Zimmer Biomet Tibial Baseplate and
Implantation
NOTE: In order to attach the Canary CTE to the Zimmer Biomet Persona® Knee tibial plate, the
following Canary Medical instrumentation is required:
Physician Instructions for Use
DRAFT
Page | 37
CTE Impaction Sleeve
CAUTION: Do not attempt to connect the Canary CTE to the Zimmer Biomet Persona® Knee tibial
plate without the Canary Medical instrumentation. Use of different instrumentation may result
in incorrect connection or damage to the implant components.
After preparation of the patient and confirmation of the trial devices, perform the following
steps:
1. Remove and discard the plastic cap on the Zimmer tibial plate.
2. Remove and retain the set screw on the Zimmer tibia plate.
3. Place the CTE implant into the Zimmer tibia plate while aligning the anterior lines on each
component.
4. Place the CTE Impaction Sleeve over the CTE implant and strike the CTE Impaction Sleeve
multiple times with a 2 pound surgical hammer.
5. Tighten the set screw on the Zimmer tibia plate using the torque limiting Zimmer
instrumentation.
6. Remove the CTE Impaction Sleeve.
7. After successful attachment of the CTE implant to the Zimmer tibia plate, discard the
impaction sleeve as medical waste.
CAUTION: Be sure to remove the CTE Impaction Sleeve from the assembled prosthesis. Do not
implant the Impaction Sleeve.
WARNING: The Impaction Sleeve is single use only. After use, discard the Impaction sleeve as
medical waste. Re-use of single use devices can result in serious patient injury, infection, or
death.
8. Optional: A Self-Test can be performed from the OR Base Station to ensure the CTE
implant is still functional after assembly.
9. Mix and apply the PMMA bone cement and apply it to the Zimmer Biomet tibial plate and
10. Place the assembled knee prosthesis into the anatomy and proceed as usual for a TKA
CTE implant.
procedure.
Page | 38
Physician Instructions for Use
DRAFT
11.4.5. Postoperative: Link the CTE implant and Knee Prosthesis Components to the Patient
After the surgery is complete, use the OR PC Application and Bar Code Scanner to link the
patient’s implant components with the patient in the patient’s account using the steps below:
1. Go to the Main Menu screen.
2. Under “Postoperative,” click on “Link Implant – Patient.”
3. Choose the patient’s name from the list or click “Manually Enter Patient” to enter the
patient’s information. A search function is also available at the top of the screen.
4. Choose the implant location (left or right knee) and click “Next.”
5. Click in the text boxes to enter or scan the serial numbers from the labels of the CTE and
other Zimmer Biomet Persona® Personalized Knee System implant components. Ensure
you enter all the required information (denoted by red asterisks), otherwise you will not
be able to submit the information.
6. Click “Submit” to save the information to the patient account.
Dispose of any non-reusable instrumentation as biohazard hospital waste.
11.5. HCP
Remind the patient to verify upon returning home that the Home Base Station System is
located correctly, powered on, and connected to the home wireless Internet connection.
Remind the patient of the availability of the Patient Dashboard to review gait and activity
information.
After Post-Operative day 3, log on to the Canary Medical account to view the patient’s
gait and activity information on the HCP Dashboard. The data presented is for the
previous sample day’s activity.
When the patient returns home, the patient or a caregiver ensures that the Home Base Station
System is functioning by:
Verifying that the Home Base Station System is still connected to their home Wi-Fi by
viewing the status light on the base station and ensuring it is green
Verifying that the Home Base Station Unit is located within 6 feet of the patient’s sleeping
Physician Instructions for Use
DRAFT
11.5.1.Patient
area
Page | 39
The CTE with CHIRP System is designed to operate autonomously. Using its proprietary data
collection and power management algorithms, the CTE implant will collect, store, and transmit
encrypted raw kinematic data from the implant’s triaxial accelerometers and triaxial gyroscopes
via the patient’s home Base Station unit to the Cloud. The data will then be processed, analyzed,
and converted to quantifiable Canary Medical Gait Parameter metrics.
After post-operative day 3, the patient can log on to the previously-established Canary account
to view the Patient Dashboard. The patient can use an Internet browser to view the Patient
Dashboard by following the instructions in the Patient IFU. Gait parameters presented on the
Patient Dashboard are for the previous sample day’s activity.
12. ADVERSE EVENTS
Potential adverse events associated with TKA and/or the Zimmer Biomet Persona® Personalized
Knee System with the CTE with CHIRP System include but are not limited to those listed below:
Infection
Knee-joint infection
Heart attack
Stroke
Blood clots
Bleeding
Slow wound healing
Allergic reaction to the knee implant components
Blood vessel damage
Nerve damage
Stiffness
Poor range of motion
Swelling and joint pain
Knee instability and/or dislocation
Loosening or fracture of the knee implant components
Bone fracture or break during surgery
Leg length discrepancy
13. COMPATIBILITY WITH OTHER DEVICES
The CTE implant is designed to interface with the Tibia Plate of the Zimmer Biomet Persona®
Personalized Knee System. The surgical team attaches the CTE to the Zimmer device to form the
patient’s knee prosthesis. Specialized Canary Medical instrumentation is used during the
attachment process and tibia preparation.
Physician Instructions for Use
DRAFT
Page | 40
The CHIRP System is compatible with a range of computing devices and systems. Table 6 lists
the compatible device types and operating systems, and minimum specifications that will be
required in order for data from the CTE to be accessible from the Canary Medical website to
health care providers and patients.
Table 6. Compatible Device Types and Operating Systems
1024 x 768
Microsoft Edge
Google Chrome
Windows 10 or higher
Minimum supported resolution
Supported browsers and minimum versions
Minimum operating environment for the PC that runs
the Base Station Setup Tool (patient PC)
Minimum number of USB ports for patient PC
1
14. COMPONENT SPECIFICATIONS
Table 7: CTE Specifications
Category
Specification
Weight
25 grams
Dimensions
OAL (w/Antenna Cover attached): 3.063 inches (REF)
OAL (without Antenna Cover): 2.138” [+/- 0.005 inches]
Body OD (Grooved with Canary Medical Imprint): 0.511” [+ 0.000/ -0.004
inches]
Tip OD: 0.285” [+/- 0.004 inches]
Antenna Cover Thread: M10 x .5
Power Source
Battery, Single Cell, Lithium Carbon Monofluoride (Li/CFx) 3.21V (@nom.)
Battery
Case: Ti alloy, Grade 2.
Weight (Battery): 7.6g
Self-Discharge: Less than 0.5%/year.
Physician Instructions for Use
DRAFT
Page | 41
Category
Specification
Long Term Storage: Up to 36 months at 22 +/- 6 degrees C, stored in supplier’s
ambient environment.
Normal Operating Conditions: The battery shall meet all performance
requirements over a temperature range of 35 to 41°C inclusive.
Lowest Usage Current Consumption: < 200 nA
Communication Standby Current Consumption: < 500 nA
Low Resolution Mode Current Consumption: < 15µA.
Medium Resolution Mode Current Consumption: <2000µA
High Resolution Mode Current Consumption: <2000µA
Current
Consumption
Five (5) Modes of Operation for the CTE implant (without patient
involvement):
Mode of Operation
Deep Sleep Mode;
Standby Mode;
Low Resolution Mode (Step count);
High Rate Mode;
Six Degree of Freedom (6DOF) Mode.
Continuous Sampling:
Step Counting and detection of significant motion;
Detection of linear acceleration and angular rate of motion;
Collection of acceleration data at high sampling rates (up to 800 Hz).
Temperature, Storage: 15C to 25C.
Temperature, Transportation Environmental: Per ISTA 3A, method ASTM
D4332.
Relative Humidity, Storage: 10% to 90%.
Relative Humidity, Transportation Environmental: Per ISTA 3A, method
ASTM D4332.
Standard (e.g., 60601-, Type, e.g., BF)
Safe Storage and
Transport
Temperature Range
Safe Storage and
Transport Relative
Humidity
Protection from
Electric Shock
Page | 42
Physician Instructions for Use
DRAFT
Category
Specification
Protection from
Ingress of Liquids
Standard IEC-60601, clause 6.3. [Also identified in ISO-14708-1 and IEC-
60529.]
CTE Impaction
Sleeve
OAL: 63.5 mm
Max OD: 22 mm
ID: 13.08 mm
Material: 17-4 PH SS
Table 6: OR Base Station System Specifications
OR Base Station Unit
Specification
Weight
Dimensions
Power Source
18 cm wide by 18 cm long by 5 cm high.
AC/DC; external mains; USB AC/DC power adapter or
from an external PC.
1 lb.
Battery
Battery
CR1220, coin cell.
Physician Instructions for Use
DRAFT
Page | 43
OR Base Station Unit
Specification
Mode of Operation
Operational Modes:
Power on (w/self-test)
Normal operating
Fault (self-test failure)
Mode of Operation:
The surgical team uses the OR Base Station System
before and during the TKA surgery to register the patient
and initiate the CTE implant so that it will begin
collecting data after the patient’s surgery. The OR Base
Station System consists of an OR Base Station unit,
dedicated laptop PC loaded with the Canary software
application, barcode scanner, and USB cables.
Recommended Operating Conditions
Temperature: +5°C to +40°C;
Relative Humidity: 15% to 93% (non-condensing).
Safe Storage and Transport Temperature
Range
Storage: 15° C to 25° C
Transportation Environment: Per ISTA 3A, method
ASTM D4332.
Safe Storage and Transport Relative Humidity Storage: 10% to 90% (noncondensing).
Transportation Environment: 10% to 95%
(noncondensing).
Protection from Electric Shock
Per IEC 60601-1-11, clause 10.1.3 b
Protection from Ingress of Liquids
Per IEC-60529, OR base station rated as IP21.
Audible Output Levels
None. (Not applicable.)
Physician Instructions for Use
DRAFT
Page | 44
Specification
Specification
Dell
Windows 10
Specification
TBD
OR Base Station Unit
Personal Computer
Manufacturer
Operating System
Canary Software
Version
Manufacturer
Manufacturer
Dimensions
Weight
Dimensions
Page | 45
Bar Code Scanner and Cable
Specification
USB Power and Data Cables
Specification
Aibecy Handheld 2.4G Wireless 1D/2D/QR Barcode
Scanner Bar Code Reader with USB Receiver 4000 Code
Storage Capacity for POS PC Android IOS.
Qualtek 3021084-03 (OR 3ft USB Data cable)
USB 2.0 Cable A Male to Micro B Male, Up Angle 3.00'
(914.4mm) Shielded, USB Data Cable.
Power Source
AC/DC
Table 7: Home Base Station System Specifications
Home Base Station Unit
Specification
1 lb.
18 cm wide by 18 cm long by 5 cm high.
Physician Instructions for Use
DRAFT
Home Base Station Unit
Specification
Power Source
Battery
LED Light Output
Mode of Operation
AC/DC
Battery
CR1220, coin cell.
Red, Green - 78 mW
Blue - 80 mW
Operational Modes:
Power on (w/self-test)
Normal operating
Fault (self-test failure)
Mode of Operation:
Red, Green, Blue (RGB) 625nm Red, 525nm Green,
470nm Blue LED Indication - Discrete 1.9V Red, 3.3V
Green, 3.3V Blue 4-PLCC
The Home Base Station System is located at the
patient’s home, where it is set up by the patient prior
to the date of surgery. The Home Base Station System
provides an interface for communication with the
patient’s CTE implant. It consists of a Home Base
Station unit, the patient’s USB-enabled personal
computer, the patient’s wireless Internet connection,
and a USB power and data cable. After TKA surgery,
the Home Base Station unit begins collecting the
patient’s gait and activity information from the
CTE. The Home Base Station unit transmits the data to
the Cloud, and also has the capability to store the data
for up to thirty days.
Physician Instructions for Use
DRAFT
Page | 46
Home Base Station Unit
Specification
Recommended Operating Conditions
Temperature: +5°C to +40°C;
Relative Humidity: 15% to 93% (non-condensing).
Safe Storage and Transport Temperature
Range
Storage: 15° C to 25° C
Transportation Environment: Per ISTA 3A, method
ASTM D4332.
Safe Storage and Transport Relative Humidity Storage: 10% to 90% (noncondensing).
Transportation
(noncondensing).
Environment:
10%
to
95%
Protection from Electric Shock
Per IEC 60601-1-11, clause 10.1.3 b
Protection from Ingress of Liquids
Per IEC-60529, OR base station rated as IPX1.
Audible Output Levels
None. (Not applicable.)
Personal Computer
Specification
Manufacturer
Patient’s Choice
Operating System
Windows 10
USB Power and Data Cables
Specification
Manufacturer
Molex 687680400 (Home 2m USB cable)
CUI SWM6-5-NH-I38 (Home USB Power Supply)
55.6mm x 27.1mm x 37.2mm (Home USB Power Supply)
Dimensions
Power Source
Page | 47
AC/DC
Physician Instructions for Use
DRAFT
15. DATA SECURITY AND PATIENT PRIVACY
All communication between the CTE implant and the Base Station units employs a unique
communication protocol, with each CTE having a unique radio that is assigned to it in
manufacturing. Base stations can communicate with only one CTE at a time using this radio ID.
NOTE: A patient could potentially have two CTE implants (one in each knee) but would only need
one Base Station in that scenario.
The communication between base stations and CTE is also encrypted (both the data payload and
messaging) with the unique encryption key assignment during the manufacture of the CTE. In
addition, communication integrity as well as data integrity checks are applied on the data
received at both ends.
The Canary Medical Cloud Platform is designed for assuring HIPAA-compliance. When a Home
Base Station is set up by the patient, a secure connection is established between the Base Station
and the Canary Cloud and is in effect for all communication thereafter. The Home Base Station
unit decrypts messages and data from the implant, adds the serial number of the CTE, packages
and encrypts the unprocessed data before transmitting the encrypted unprocessed data to the
Cloud using standard TLS (Transport Layer Security) protocol. The communication and data are
checked for integrity by the Cloud application before it is processed to output the CMGP.
Patients who wish to receive the CTE with CHIRP System must consent to the CTE implant data
collection, storage, analysis, and sharing of their implant and basic personal and health data with
HCP(s) they designate to provide their healthcare. As such, data will be identifiable to their
healthcare providers and authorized administrators of the Canary Medical CTE with CHIRP
System. The patient will have the right to be forgotten and will have the ability to turn off the
kinematic data collection of the device after a minimum required time for data generation. If
the patient does not wish to consent, they can receive a standard of care, non-reporting tibial
extension.
Each HCP and patient user are assigned a unique username and will be prompted to enter a
password at initial login. The unique username and password is needed for logging into their
account thereafter and accessing the physician and patient dashboards, respectively.
16. COMPONENT MAINTENANCE
16.1. CTE
The CTE is an implant that remains in the body indefinitely and therefore cannot be maintained.
Physician Instructions for Use
DRAFT
Page | 48
16.2. Base Station Units and Accessories
Maintain the Base Station Units and Accessories by keeping them clean, dry, and free of
surrounding clutter.
Home Base Station: Dust with a clean, dry, soft cloth.
OR Base Station: The following solutions have been tested for safe cleaning of the OR Base
Station unit, part # 43-5570-002-14 only. Wipe the OR Base Station Unit with a soft cloth
dampened with one of these solutions.
1.
2.
3.
4.
5.
6.
7.
1:10 Bleach Solution
1:10 Mild Detergent Solution
Ammonia Solution (RTU)
70% Isopropyl Alcohol
0.5% Hydrogen Peroxide
Phenolic germicidal detergent solution (RTU)
Iodophor germicidal detergent solution (RTU)
16.3. SOFTWARE MAINTENANCE
All software updates will be initiated by Canary Medical.
17. SERVICE LIFE
17.1. CTE
WARNING: Do not immerse the base stations in water or cleaning agents as this could cause
electrocution.
The service life of the CTE is estimated to be at least ten years based on; a) accelerated discharge
testing of the batteries, b) bench testing of current consumption by the CTE electronics, and c)
assuming no more than 1000 sampling days are programmed into the CTE. However, the CTE is
designed for up to 20 years of service life.
17.2. Base Station Units and Accessories
The Base Station Units and Accessories are intended to last for 3 - 5 years and can be replaced in
case of them being non-operational.
Physician Instructions for Use
DRAFT
Page | 49
18. SERVICING
18.1. CTE
The CTE is an implant, thus, it is unable to undergo service from a mechanical perspective,
however, the CTE can receive software updates initiated from the Canary Cloud.
18.2. Base Station Units and Accessories
If a Base Station Unit or accessory is not working properly, please see Appendix 3,
Troubleshooting, for a potential solution to the problem. If the issue cannot be fixed, please call
Canary Medical for instructions on how to further troubleshoot or return the unit for
replacement.
Physician Instructions for Use
DRAFT
Page | 50
19. DISPOSAL
19.1. CTE
The CTE is a single-use device. If explantation is necessary, do not reuse, reprocess, or resterilize
the CTE. Dispose of the explanted CTE according to your facility policy as biohazard medical
electronics waste. Do not incinerate the explanted CTE.
In the event of the death of a patient who has received the CTE implant, inform end-of-life staff
that the patient has an implant containing a battery.
WARNING: Re-use of single-use components could result in patient infection, injury, or death.
WARNING: The CTE contains a battery. Do not incinerate the CTE by cremation or any other
means. This could result in explosions that damage equipment or cause injury to people.
19.2. Canary Medical Surgical Instrumentation
The Canary Medical instrumentation, except for the CTE Impaction Sleeve, is reusable.
Reprocessing of any of the Canary Medical instrumentation (except the CTE Impaction Sleeve)
must be accomplished according to the Canary Medical Instrument Care Instructions for Use,
document # K01-INT-300019.
The CTE Impaction Sleeve is single-use only and is not reusable. After use, dispose of the CTE
Impaction Sleeve according to your facility policy as biohazard medical waste.
WARNING: Re-use of single-use components could result in patient infection, injury, or death.
19.3. Base Station Units and Accessories
Dispose of Base Station Units and Accessories as electronics waste or return them to Canary
Medical.
The Canary Bird logo (color and black and white) and the following text are pending trademarks
of Canary Medical:
20. WARRANTY
TBD
21. PATENTS AND TRADEMARKS
CANARY MEDICAL
Page | 51
Physician Instructions for Use
DRAFT
CHIRP
CHARM
DIGITAL REFORMULATION
The Zimmer Biomet Persona® Personalized Knee System is a registered trademark of Zimmer
Biomet.
Physician Instructions for Use
DRAFT
Page | 52
d
r
a
d
n
a
t
S
e
h
t
n
i
l
o
b
m
y
S
e
h
t
f
o
e
l
t
i
T
d
r
a
d
n
a
t
S
e
h
t
f
o
e
l
t
i
T
d
n
a
r
e
b
m
u
N
n
o
i
t
a
n
g
i
s
e
D
i
g
n
n
a
e
M
l
o
b
m
y
S
o
g
o
L
l
a
c
i
d
e
M
y
r
a
n
a
C
l
8
e
b
a
T
i
.
s
g
n
n
a
e
m
r
i
e
h
t
d
n
a
t
n
e
m
u
c
o
d
s
i
h
t
n
i
d
e
s
u
s
l
o
b
m
y
s
e
h
t
s
w
o
h
s
8
e
b
a
T
l
Y
R
A
S
S
O
L
G
S
L
O
B
M
Y
S
–
1
X
D
N
E
P
P
A
I
r
e
b
m
u
N
l
a
i
r
e
S
n
o
e
s
u
r
o
f
s
l
o
b
m
y
s
l
a
c
i
h
p
a
r
G
8
9
4
2
—
0
0
0
7
O
S
I
r
e
b
m
u
n
l
a
i
r
e
s
e
u
q
n
u
e
h
T
i
s
l
o
b
m
y
s
d
e
r
e
t
s
i
g
e
R
-
-
t
n
e
m
p
u
q
e
i
y
b
e
c
i
v
e
d
e
h
t
o
t
d
e
n
g
i
s
s
a
e
r
e
H
n
e
p
O
n
o
e
s
u
r
o
f
s
l
o
b
m
y
s
l
a
c
i
h
p
a
r
G
9
7
0
3
—
0
0
0
7
O
S
I
e
h
t
n
o
n
o
i
t
a
c
i
d
n
i
n
A
s
l
o
b
m
y
s
d
e
r
e
t
s
i
g
e
R
-
-
t
n
e
m
p
u
q
e
i
t
i
e
r
e
h
w
e
g
a
k
c
a
p
s
’
e
c
i
v
e
d
e
h
t
y
b
e
c
i
v
e
d
r
e
r
u
t
c
a
f
u
n
a
m
r
e
r
u
t
c
a
f
u
n
a
m
e
h
t
d
e
n
e
p
o
e
b
o
t
s
i
e
z
i
l
i
r
e
t
s
-
e
R
t
o
N
o
D
n
o
e
s
u
r
o
f
s
l
o
b
m
y
s
l
a
c
i
h
p
a
r
G
8
0
6
2
-
0
0
0
7
O
S
I
o
t
t
o
n
r
e
s
u
e
h
t
s
t
c
u
r
t
s
n
I
6
.
2
.
5
e
s
u
a
l
c
1
-
3
2
2
5
1
O
S
I
s
l
o
b
m
y
s
d
e
r
e
t
s
i
g
e
R
-
-
t
n
e
m
p
u
q
e
i
e
c
i
v
e
d
e
h
t
e
z
i
l
i
r
e
t
s
-
e
r
r
e
b
m
u
N
e
u
g
o
a
t
a
C
l
n
o
e
s
u
r
o
f
s
l
o
b
m
y
s
l
a
c
i
h
p
a
r
G
3
9
4
2
—
0
0
0
7
O
S
I
r
e
d
r
o
r
o
e
u
g
o
a
t
a
c
l
e
h
T
s
l
o
b
m
y
s
d
e
r
e
t
s
i
g
e
R
-
-
t
n
e
m
p
u
q
e
i
e
h
t
o
t
d
e
n
g
i
s
s
a
r
e
b
m
u
n
r
e
r
u
t
c
a
f
u
n
a
M
n
o
e
s
u
r
o
f
s
l
o
b
m
y
s
l
a
c
i
h
p
a
r
G
2
8
0
3
—
0
0
0
7
O
S
I
s
’
e
c
i
v
e
d
e
h
t
f
o
e
m
a
n
e
h
T
s
l
o
b
m
y
s
d
e
r
e
t
s
i
g
e
R
-
-
t
n
e
m
p
u
q
e
i
r
e
r
u
t
c
a
f
u
n
a
m
e
s
U
r
o
f
s
n
o
i
t
c
u
r
t
s
n
I
n
a
i
c
i
s
y
h
P
T
F
A
R
D
3
5
|
e
g
a
P
e
d
i
x
O
e
n
e
l
y
h
t
E
g
n
i
s
U
d
e
z
i
l
i
r
e
t
S
n
o
e
s
u
r
o
f
s
l
o
b
m
y
s
l
a
c
i
h
p
a
r
G
1
0
5
2
-
0
0
0
7
O
S
I
e
h
t
t
a
h
t
r
e
s
u
e
h
t
s
l
l
e
T
s
l
o
b
m
y
S
—
s
e
c
i
v
e
d
l
a
c
i
d
e
M
3
2
.
3
e
s
u
a
l
c
1
-
3
2
2
5
1
O
S
I
d
n
a
g
n
i
l
l
e
b
a
l
,
s
l
e
b
a
l
e
c
i
v
e
d
l
a
c
i
d
e
m
h
t
i
w
d
e
s
u
e
b
o
t
d
e
i
l
p
p
u
s
e
b
o
t
n
o
i
t
a
m
r
o
f
n
i
s
l
o
b
m
y
s
d
e
r
e
t
s
i
g
e
R
-
-
t
n
e
m
p
u
q
e
i
h
t
i
w
d
e
z
i
l
i
r
e
t
s
s
i
e
c
i
v
e
d
e
d
i
x
O
e
n
e
l
y
h
t
E
t
n
e
m
p
u
q
E
i
l
a
c
i
r
t
c
e
E
l
l
a
c
i
d
e
M
2
.
7
e
s
u
a
l
c
1
-
1
0
6
0
6
C
E
I
,
s
l
e
b
a
l
e
c
i
v
e
d
l
a
c
i
d
e
m
h
t
i
w
d
e
s
u
e
b
o
t
s
l
o
b
m
y
S
—
s
e
c
i
v
e
d
l
a
c
i
d
e
M
2
.
4
.
5
e
s
u
a
l
c
1
-
3
2
2
5
1
O
S
I
d
e
i
l
p
p
u
s
e
b
o
t
n
o
i
t
a
m
r
o
f
n
i
d
n
a
g
n
i
l
l
e
b
a
l
d
r
a
d
n
a
t
S
e
h
t
n
i
l
o
b
m
y
S
e
h
t
f
o
e
l
t
i
T
d
r
a
d
n
a
t
S
e
h
t
f
o
e
l
t
i
T
d
n
a
r
e
b
m
u
N
n
o
i
t
a
n
g
i
s
e
D
i
g
n
n
a
e
M
l
o
b
m
y
S
e
s
u
-
e
R
t
o
N
o
D
n
o
e
s
u
r
o
f
s
l
o
b
m
y
s
l
a
c
i
h
p
a
r
G
1
5
0
1
-
0
0
0
7
O
S
I
o
t
t
o
n
r
e
s
u
e
h
t
s
t
c
u
r
t
s
n
I
s
l
o
b
m
y
s
d
e
r
e
t
s
i
g
e
R
-
-
t
n
e
m
p
u
q
e
i
e
c
i
v
e
d
e
h
t
e
s
u
-
e
r
—
y
r
e
g
r
u
s
r
o
f
s
t
n
a
p
m
l
I
2
.
1
1
e
s
u
a
l
c
,
1
-
8
0
7
4
1
O
S
I
:
1
t
r
a
P
—
s
e
c
i
v
e
d
l
a
c
i
d
e
m
l
e
b
a
t
n
a
p
m
l
i
e
v
i
t
c
A
r
o
f
d
n
a
g
n
i
k
r
a
m
,
y
t
e
f
a
s
r
o
f
s
t
n
e
m
e
r
i
u
q
e
r
l
a
r
e
n
e
G
r
e
r
u
t
c
a
f
u
n
a
m
e
h
t
y
b
d
e
d
i
v
o
r
p
e
b
o
t
n
o
i
t
a
m
r
o
f
n
i
e
t
a
d
y
b
e
s
U
n
o
e
s
u
r
o
f
s
l
o
b
m
y
s
l
a
c
i
h
p
a
r
G
7
0
6
2
-
0
0
0
7
O
S
I
o
t
t
o
n
r
e
s
u
e
h
t
s
m
r
o
f
n
I
r
o
f
s
t
n
a
p
m
l
I
5
.
1
1
d
n
a
.
7
9
e
s
u
a
l
c
,
1
-
8
0
7
4
1
O
S
I
e
g
a
k
c
a
p
e
h
t
n
o
d
e
t
s
i
l
e
t
a
d
s
l
o
b
m
y
s
d
e
r
e
t
s
i
g
e
R
-
-
t
n
e
m
p
u
q
e
i
e
h
t
r
e
t
f
a
e
c
i
v
e
d
e
h
t
e
s
u
—
s
e
c
i
v
e
d
l
a
c
i
d
e
m
l
e
b
a
t
n
a
p
m
l
i
e
v
i
t
c
A
—
y
r
e
g
r
u
s
g
n
i
k
r
a
m
,
y
t
e
f
a
s
r
o
f
s
t
n
e
m
e
r
i
u
q
e
r
l
a
r
e
n
e
G
:
1
t
r
a
P
d
e
t
t
a
m
r
o
f
s
i
e
t
a
d
e
h
T
e
h
t
y
b
d
e
d
i
v
o
r
p
e
b
o
t
n
o
i
t
a
m
r
o
f
n
i
r
o
f
d
n
a
i
o
t
g
n
d
r
o
c
c
a
D
D
M
M
-
Y
Y
Y
Y
-
r
e
r
u
t
c
a
f
u
n
a
m
1
0
6
8
O
S
I
e
s
U
r
o
f
s
n
o
i
t
c
u
r
t
s
n
I
n
a
i
c
i
s
y
h
P
T
F
A
R
D
4
5
|
e
g
a
P
n
o
i
t
c
u
r
t
s
n
i
o
t
r
e
f
e
R
l
s
r
o
o
c
y
t
e
f
a
S
-
-
s
l
o
b
m
y
s
l
a
c
i
h
p
a
r
G
2
0
0
M
-
0
1
0
7
O
S
I
d
a
e
r
o
t
r
e
s
u
e
h
t
s
t
c
e
r
i
D
t
e
l
k
o
o
b
/
l
a
u
n
a
m
s
n
g
i
s
y
t
e
f
a
s
d
e
r
e
t
s
i
g
e
R
-
-
s
n
g
i
s
y
t
e
f
a
s
d
n
a
e
s
u
r
o
f
s
n
o
i
t
c
u
r
t
s
n
i
e
h
t
s
n
o
i
t
a
t
n
e
s
e
r
p
e
R
—
e
m
i
t
d
n
a
e
t
a
D
1
.
2
A
1
-
1
0
6
8
O
S
I
l
s
e
u
r
c
i
s
a
B
:
1
t
r
a
P
—
e
g
n
a
h
c
r
e
t
n
i
n
o
i
t
a
m
r
o
f
n
i
r
o
f
—
s
e
c
i
v
e
d
l
a
c
i
d
e
m
l
e
b
a
t
n
a
p
m
l
i
e
v
i
t
c
A
—
y
r
e
g
r
u
s
g
n
i
k
r
a
m
,
y
t
e
f
a
s
r
o
f
s
t
n
e
m
e
r
i
u
q
e
r
l
a
r
e
n
e
G
:
1
t
r
a
P
e
h
t
y
b
d
e
d
i
v
o
r
p
e
b
o
t
n
o
i
t
a
m
r
o
f
n
i
r
o
f
d
n
a
r
e
r
u
t
c
a
f
u
n
a
m
.
e
r
u
t
c
a
f
u
n
a
M
f
o
e
t
a
D
r
o
f
s
t
n
a
p
m
l
I
6
.
1
1
d
n
a
.
6
9
e
s
u
a
l
c
,
1
-
8
0
7
4
1
O
S
I
s
a
w
e
c
i
v
e
d
e
h
t
e
t
a
D
d
e
r
u
t
c
a
f
u
n
a
m
d
r
a
d
n
a
t
S
e
h
t
n
i
l
o
b
m
y
S
e
h
t
f
o
e
l
t
i
T
d
r
a
d
n
a
t
S
e
h
t
f
o
e
l
t
i
T
d
n
a
r
e
b
m
u
N
n
o
i
t
a
n
g
i
s
e
D
i
g
n
n
a
e
M
l
o
b
m
y
S
c
i
s
a
b
r
o
f
s
t
n
e
m
e
r
i
u
q
e
r
l
a
r
e
n
e
G
:
1
t
r
a
P
-
t
n
e
m
p
u
q
e
i
l
a
c
i
r
t
c
e
e
l
l
a
c
i
d
e
M
1
-
1
0
6
0
6
C
E
I
3
.
2
.
7
1
-
1
0
6
0
6
C
E
I
e
c
n
a
m
r
o
f
r
e
p
l
a
i
t
n
e
s
s
e
d
n
a
y
t
e
f
a
s
l
y
b
e
a
s
o
t
e
c
i
v
e
d
s
i
h
t
s
t
c
i
r
t
s
e
r
w
a
l
l
a
r
e
d
e
F
:
n
o
i
t
u
a
C
y
l
n
o
e
s
u
n
o
i
t
p
i
r
c
s
e
r
p
r
o
F
.
n
a
i
c
i
s
y
h
p
a
f
o
r
e
d
r
o
e
h
t
n
o
r
o
t
h
g
i
l
n
u
s
m
o
r
f
y
a
w
a
p
e
e
K
n
o
e
s
u
r
o
f
s
l
o
b
m
y
s
l
a
c
i
h
p
a
r
G
4
2
6
0
-
0
0
0
7
O
S
I
r
e
t
r
o
p
s
n
a
r
t
e
h
t
s
t
c
u
r
t
s
n
I
s
l
o
b
m
y
s
d
e
r
e
t
s
i
g
e
R
-
-
t
n
e
m
p
u
q
e
i
o
t
e
g
a
k
c
a
p
e
c
i
v
e
d
e
h
t
f
o
.
y
r
d
p
e
e
K
n
o
e
s
u
r
o
f
s
l
o
b
m
y
s
l
a
c
i
h
p
a
r
G
6
2
6
0
-
0
0
0
7
O
S
I
r
e
t
r
o
p
s
n
a
r
t
e
h
t
s
t
c
u
r
t
s
n
I
s
l
o
b
m
y
s
d
e
r
e
t
s
i
g
e
R
-
-
t
n
e
m
p
u
q
e
i
o
t
e
g
a
k
c
a
p
e
c
i
v
e
d
e
h
t
f
o
,
s
l
e
b
a
l
e
c
i
v
e
d
l
a
c
i
d
e
m
h
t
i
w
d
e
s
u
e
b
o
t
s
l
o
b
m
y
S
—
s
e
c
i
v
e
d
l
a
c
i
d
e
M
4
.
3
.
5
e
s
u
a
l
c
1
-
3
2
2
5
1
O
S
I
d
e
i
l
p
p
u
s
e
b
o
t
n
o
i
t
a
m
r
o
f
n
i
d
n
a
g
n
i
l
l
e
b
a
l
e
g
a
k
c
a
p
e
c
i
v
e
d
e
h
t
p
e
e
k
y
r
d
e
s
U
r
o
f
s
n
o
i
t
c
u
r
t
s
n
I
n
a
i
c
i
s
y
h
P
T
F
A
R
D
5
5
|
e
g
a
P
F
C
e
p
y
T
f
o
o
r
P
-
n
o
i
t
a
l
l
i
r
b
i
f
e
D
t
r
a
P
d
e
i
l
p
p
A
d
e
g
a
m
a
d
e
r
u
s
s
e
r
p
c
i
r
e
h
p
s
o
m
t
A
n
o
i
t
a
t
i
m
i
l
t
i
m
i
l
e
r
u
t
a
r
e
p
m
e
T
1
1
.
9
e
s
u
a
l
c
1
-
8
0
7
4
1
O
S
I
e
g
a
r
o
t
s
d
n
a
t
r
o
p
s
n
a
r
t
n
o
i
t
a
t
i
m
i
l
y
t
i
d
m
u
H
i
1
1
.
9
e
s
u
a
l
c
1
-
8
0
7
4
1
O
S
I
e
g
a
r
o
t
s
d
n
a
t
r
o
p
s
n
a
r
t
1
1
.
9
e
s
u
a
l
c
1
-
8
0
7
4
1
O
S
I
e
g
a
r
o
t
s
d
n
a
t
r
o
p
s
n
a
r
t
s
i
e
g
a
k
c
a
p
f
i
e
s
u
t
o
n
o
D
0
1
e
s
u
a
l
c
1
-
7
0
6
1
1
O
S
I
8
.
2
.
5
e
s
u
a
l
c
1
-
3
2
2
5
1
O
S
I
e
s
u
o
t
t
o
n
r
e
s
u
e
h
t
s
t
c
e
r
i
D
s
i
e
c
i
v
e
d
e
h
t
s
e
t
a
c
i
d
n
I
S
H
o
R
e
h
t
h
t
i
w
t
n
a
i
l
p
m
o
c
e
h
t
n
i
d
n
u
o
f
n
o
i
t
a
u
g
e
r
l
i
e
v
i
t
c
e
r
i
D
n
o
n
U
n
a
e
p
o
r
u
E
C
E
/
5
9
/
2
0
0
2
t
i
m
i
l
e
r
u
t
a
r
e
p
m
e
t
-
0
0
0
7
O
S
I
t
i
m
i
l
y
t
i
d
m
u
h
i
0
2
6
2
O
S
I
t
i
m
i
l
c
i
r
e
h
p
s
o
m
t
a
1
2
6
2
-
0
0
0
7
e
g
a
k
c
a
p
e
h
t
f
i
e
c
i
v
e
d
e
h
t
r
o
d
e
n
e
p
o
n
e
e
b
s
a
h
d
e
g
a
m
a
d
C
E
I
d
n
a
t
r
a
p
d
e
i
l
p
p
a
F
C
l
o
b
m
y
s
6
3
3
5
-
7
1
4
0
6
.
1
5
.
5
.
8
e
s
u
a
l
c
1
-
1
0
6
0
6
C
E
I
e
p
y
t
f
o
o
r
p
-
n
o
i
t
a
l
l
i
r
b
i
f
e
d
e
s
U
r
o
f
s
n
o
i
t
c
u
r
t
s
n
I
n
a
i
c
i
s
y
h
P
T
F
A
R
D
6
5
|
e
g
a
P
d
r
a
d
n
a
t
S
e
h
t
n
i
l
o
b
m
y
S
e
h
t
f
o
e
l
t
i
T
d
r
a
d
n
a
t
S
e
h
t
f
o
e
l
t
i
T
d
n
a
r
e
b
m
u
N
n
o
i
t
a
n
g
i
s
e
D
i
g
n
n
a
e
M
l
o
b
m
y
S
d
e
i
l
p
p
u
s
e
b
o
t
n
o
i
t
a
m
r
o
f
n
i
d
n
a
g
n
i
l
l
e
b
a
l
,
s
l
e
b
a
l
e
c
i
v
e
d
l
a
c
i
d
e
m
h
t
i
w
d
e
s
u
e
b
o
t
s
l
o
b
m
y
S
t
h
g
i
l
n
u
s
m
o
r
f
e
g
a
k
c
a
p
—
s
e
c
i
v
e
d
l
a
c
i
d
e
M
2
.
3
.
5
e
s
u
a
l
c
1
-
3
2
2
5
1
O
S
I
e
c
i
v
e
d
e
h
t
t
c
e
t
o
r
p
e
c
n
a
n
o
s
e
r
c
i
t
e
n
g
a
m
f
o
y
t
e
f
a
s
e
h
t
f
o
t
n
e
m
s
s
e
s
s
A
l
e
b
a
t
n
a
p
m
l
i
e
v
i
t
c
a
n
a
h
t
i
w
s
t
n
e
i
t
a
p
r
o
f
i
g
n
g
a
m
i
4
0
-
8
1
0
2
4
7
9
0
1
R
T
/
O
S
I
e
c
i
v
e
d
l
a
c
i
d
e
m
i
t
n
e
m
p
u
q
e
I
I
s
s
a
C
l
6
.
2
.
7
e
s
u
a
l
c
1
-
1
0
6
0
6
C
E
I
:
n
o
i
t
a
c
i
f
i
s
s
a
l
c
l
a
c
i
r
t
c
e
e
l
d
r
a
d
n
a
t
S
e
h
t
n
i
l
o
b
m
y
S
e
h
t
f
o
e
l
t
i
T
d
r
a
d
n
a
t
S
e
h
t
f
o
e
l
t
i
T
d
n
a
r
e
b
m
u
N
n
o
i
t
a
n
g
i
s
e
D
i
g
n
n
a
e
M
l
o
b
m
y
S
-
7
1
4
0
6
C
E
I
d
n
a
I
I
s
s
a
C
l
l
o
b
m
y
s
2
7
1
5
h
t
i
w
l
a
n
o
i
t
i
d
n
o
C
I
R
M
.
1
1
.
3
.
7
2
0
5
2
F
M
T
S
A
:
l
o
b
m
y
s
l
o
b
m
y
s
n
o
i
t
a
c
i
f
i
t
r
e
c
L
T
R
N
f
o
n
o
i
t
a
r
a
l
c
e
D
C
C
F
y
t
i
m
r
o
f
n
o
C
e
s
U
r
o
f
s
n
o
i
t
c
u
r
t
s
n
I
n
a
i
c
i
s
y
h
P
T
F
A
R
D
7
5
|
e
g
a
P
APPENDIX 2 – DEFINITIONS
Table 12
Term
Definition
Base Station Subsystem
Base Station unit
Cadence
CTE implant
Cloud
transmission
The Base Station subsystem serves as a conduit
between the CTE implant and the Cloud subsystem.
The Base Station subsystem consists of a Base Station
unit and additional components
(i.e. network-
connected PC, PC Application, etc.) to establish an
appropriate
the use
environment.
The Base Station unit is an intermediary receiver /
transmitter that is able to wirelessly communicate with
a CTE implant. The Base Station interfaces with either
software or the Cloud directly to facilitate retrieving
and storing data from the CTE implant for storage and
processing in the Cloud.
The average amount of steps per minute
center
in
The CTE implant is an implantable tibial extension that
collects data and wirelessly transmits data from a
Patient.
Simplified terminology used to refer to the Canary
Closed Cloud System. The Canary Closed Cloud System
is an external database that resides on the Internet and
contains software for driving schedules, settings, and
configuration data reporting for the collection system,
and stores the telemetry collected from the CTE
implant, uploaded via the Base Station system.
Distance
Total distance traveled while walking
Gait
The form of ambulation/locomotion
Physician Instructions for Use
DRAFT
Page | 58
Gait Cycle or Stride
Term
HCP
Kinematic
Processed Data
Range of Motion
Raw Data
Step Count
Stride Length
Walking Speed
Definition
Sequence of movements during locomotion in which
one foot contacts the ground to when that same foot
contacts the ground again
Persons who have education in health care and are
directly related to the provision of health care services
(i.e. surgeons, physicians, physician’s assistants,
nurses, nursing assistants, therapists, technicians)
The geometric mechanics of motion
Analyzed data from the CTE implant, derived from Raw
Data.
The full movement of a joint (i.e. flexion-extension)
Three dimensional Accelerometer and three
dimensional Gyroscopic data that is collected on the
CTE implant
Number of steps taken
Average distance traveled during one gait cycle
Average sagittal plane distance walked per unit time
Physician Instructions for Use
DRAFT
Page | 59
APPENDIX 3 – TROUBLESHOOTING
Table lists some issues you might encounter with the CTE and CHIRP System, as well as some
suggested actions which may resolve the issues. If you have a problem with the system that is
not listed here or that cannot be resolved with the information provided, call Canary Medical.
Table 13
Problem
Action
I can’t reach the Canary Medical
website
Check your Internet connection and make
sure you are connected to the Internet. If
connected and still cannot reach the Canary
Medical website, try again later.
I can’t log in to my Physician Account.
Check your username and password.
I can’t see my Physician Dashboard
patient data information.
You will only see information on the selected
patient the 3rd day after surgery.
If the information is still not on your Physician
Dashboard after surgery, wait 24 hours and
check your Physician Dashboard again.
Physician Instructions for Use
DRAFT
Page | 60
Manufactured for:
Canary Medical, LLC.
2710 Loker Ave. West
Suite 350
Carlsbad, CA 92010
https://canarymedical.com/ Customer Service: 1-760-448-5066
LOMBARD GRAPHICS
Tel: (562) 692-7070
Fax: (562) 699-2123
PLEASE READ THIS PROOF COMPLETELY AND CARE-
FULLY. WE CANNOT ACCEPT RESPONSIBILITY FOR
ANY ERRORS WHICH SHOW ON THIS PROOF AND
ARE NOT CORRECTED. PLEASE SIGN AND RETURN
AS SOON AS POSSIBLE. PROOFS HELD OVER 24
HOURS WILL DELAY PRODUCTION.
OK AS IS
CORRECTIONS NEEDED
SIGNED
DATE
PLEASE FAX BACK TO (562) 699-2123
PROOF #2 7-17-20
This material is intended for health care professionals. Distribution to any other recipient
is prohibited.
Copyright Canary Medical 2020. All rights reserved.
Date of Issue or latest revision of IFU YYYY-MM-DD
Physician Instructions for Use
DRAFT
PN. K01-CTE-300004, Rev. 2
| 1 | Label | ID Label/Location Info | 3.26 MiB | July 30 2021 |
Canturio™ - TE
Tibial Extension 14mm (D) X 58mm (H)
Persona® IQ The Personalized Knee
43-5570-058-14
123456
2020-01-01
2022-12-31
IPX7
(01)00860003118306
(17)221231
(21)123456
FCC ID:
2AYAJ-CTE1
*+H124435570058141M*
*+22365123456A20MS*
(833) 722-6279
K01-CTE-300001 Rev. A
Canturio™ - TE
Tibial Extension
Persona® IQ The Personalized Knee
43-5399-058-14
123456
(01)00860003118306
(17)221231
(21)123456
FCC ID:
2AYAJ-CTE1
*+H124435570058141M*
A
*+22365123456A20MS*
Made in USA
1
3
-
2
1
-
2
2
0
2
1
0
-
1
0
-
0
2
0
2
I
L
A
C
D
E
M
Y
R
A
N
A
C
9
7
2
6
-
2
2
7
)
3
3
8
(
m
o
c
.
l
i
a
c
d
e
m
y
r
a
n
a
c
.
w
w
w
Canturio™ - TE
Tibial Extension
Persona® IQ The Personalized Knee
43-5399-058-14
123456
(01)00860003118306
(17)221231
(21)123456
FCC ID:
2AYAJ-CTE1
*+H124435570058141M*
A
*+22365123456A20MS*
Made in USA
1
3
-
2
1
-
2
2
0
2
1
0
-
1
0
-
0
2
0
2
I
L
A
C
D
E
M
Y
R
A
N
A
C
9
7
2
6
-
2
2
7
)
3
3
8
(
m
o
c
.
l
i
a
c
d
e
m
y
r
a
n
a
c
.
w
w
w
Canturio™ - TE
Tibial Extension 14mm (D) X 58mm (H)
Persona® IQ The Personalized Knee
43-5570-058-14
123456
2020-01-01
2022-12-31
IPX7
(01)00860003118306
(17)221231
(21)123456
FCC ID:
2AYAJ-CTE1
*+H124435570058141M*
*+22365123456A20MS*
(833) 722-6279
K01-CTE-300001 Rev. A
| 1 | Confidentiality Letter | Cover Letter(s) | 501.90 KiB | July 30 2021 |
June 16, 2021
Nemko Canada Inc.
303 River Road
Ottawa, ON Canada
K1V 1H2
1. Test Setup Photographs
2. External Photos
Permanent Confidentiality:
1. Schematics
2. Bill of Materials
3. Block Diagram
4. Operational Description
5.
Internal Photos
REQUEST FOR CONFIDENTIALITY FOR FCC
2710 Loker Ave West, Suite 350
Carlsbad, CA 92010
USA
2AYAJ-BS1, 2AYAJ-CTE
Name of Applicant: Canary Medical USA LLC
Address:
City:
Country:
FCC ID:
Pursuant to Sections 0.457(d) and 0.459 of the commission’s rules and Industry of Canada Regulations,
we hereby request that the following documents be held under long term confidentiality.
Short Term Confidentiality for 180 days
16-JUNE-2021
These Materials contain trade secrets and proprietary information and are not customarily released to
the public. The public disclosure of this information might be harmful to the company and provide
unjustified benefits to our competitors. These devices are available only to trained health care providers
or patients under a doctor’s prescription, and internal circuitry is not accessible to users.
Dated:
Signed: _____________________
Title:
Sr. Vice President, Research & Development
Peter Schiller
Printed:
| 1 | Test Setup photos | Test Setup Photos | 1.43 MiB | July 30 2021 / January 26 2022 | delayed release |
| frequency | equipment class | purpose | ||
|---|---|---|---|---|
| 1 | 2021-07-30 | 402 ~ 405 | TNT - Licensed Non-Broadcast Transmitter Worn on Body | Original Equipment |
| app s | Applicant Information | |||||
|---|---|---|---|---|---|---|
| 1 | Effective |
2021-07-30
|
||||
| 1 | Applicant's complete, legal business name |
Canary Medical USA LLC
|
||||
| 1 | FCC Registration Number (FRN) |
0030229884
|
||||
| 1 | Physical Address |
2710 Loker Ave West Suite 350
|
||||
| 1 |
2710 Loker Ave West
|
|||||
| 1 |
Carlsbad, CA
|
|||||
| 1 |
United States
|
|||||
| app s | TCB Information | |||||
| 1 | TCB Application Email Address |
V******@nemko.com
|
||||
| 1 | TCB Scope |
B2: General Mobile Radio And Broadcast Services equipment in the following 47 CFR Parts 22 (non-cellular) 73, 74, 90, 95, 97, & 101 (all below 3 GHz)
|
||||
| app s | FCC ID | |||||
| 1 | Grantee Code |
2AYAJ
|
||||
| 1 | Equipment Product Code |
CTE1
|
||||
| app s | Person at the applicant's address to receive grant or for contact | |||||
| 1 | Name |
N******** Y********
|
||||
| 1 | Title |
Senior Director RA/QA
|
||||
| 1 | Telephone Number |
76044********
|
||||
| 1 | Fax Number |
76044********
|
||||
| 1 |
n******@canarymedical.com
|
|||||
| app s | Technical Contact | |||||
| n/a | ||||||
| app s | Non Technical Contact | |||||
| n/a | ||||||
| app s | Confidentiality (long or short term) | |||||
| 1 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
| 1 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
| 1 | If so, specify the short-term confidentiality release date (MM/DD/YYYY format) | 01/26/2022 | ||||
| if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
| app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
| 1 | Is this application for software defined/cognitive radio authorization? | No | ||||
| 1 | Equipment Class | TNT - Licensed Non-Broadcast Transmitter Worn on Body | ||||
| 1 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | Med Radio Implant (CTE) | ||||
| 1 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
| 1 | Modular Equipment Type | Does not apply | ||||
| 1 | Purpose / Application is for | Original Equipment | ||||
| 1 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | No | ||||
| 1 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | Yes | ||||
| 1 | Grant Comments | Power Output listed is EIRP. | ||||
| 1 | Is there an equipment authorization waiver associated with this application? | No | ||||
| 1 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
| app s | Test Firm Name and Contact Information | |||||
| 1 | Firm Name |
Element Materials Technology Irvine
|
||||
| 1 | Name |
R**** W********
|
||||
| 1 | Telephone Number |
503-8********
|
||||
| 1 | Fax Number |
503-6********
|
||||
| 1 |
r******@element.com
|
|||||
| Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
| 1 | 1 | 95I | 402.00000000 | 405.00000000 | 0.0000095 | 75.0000000000 ppm | 271KF1D | ||||||||||||||||||||||||||||||||||
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC