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| 1 2 | User Manual | Users Manual | 1.49 MiB | July 30 2021 |
Canary Tibial Extension
with
CHIRP System
Patient Manual
Read this manual carefully. If you have additional
questions after reading this manual, contact your doctor.
Patient Manual
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
How to Contact Canary Medical
Customer Assistance Phone: 1-800-123-9876
Fax: 1-800-789-1234
E-mail: support@canarymedical.com
Internet: www.canarymedical.com
Mail: Canary Medical, LLC.
2710 Loker Ave. West
Suite 350
Carlsbad, CA 92010
Your Knee Implant Information
(Your health care provider can provide this information.)
Type
Zimmer Persona and Canary Tibial Extension with CHIRP System
Your Canary Medical Patient Registration Information
Model Number
CTE 1
Serial Number
Implant Date
Website
Username
Password
Page | 3
TABLE OF CONTENTS
GLOSSARY...................................................................................................................................................... 5
INTRODUCTION ............................................................................................................................................. 7
SETTING UP YOUR PATIENT ACCOUNT ......................................................................................................... 9
YOUR KNEE IMPLANT WITH CANARY TIBIAL EXTENSION & CHIRP SYSTEM ............................................... 19
HOW TO SET UP YOUR CHIRP HOME BASE STATION.................................................................................. 21
YOUR PATIENT DASHBOARD ....................................................................................................................... 35
MAINTAINING YOUR CTE WITH CHIRP SYSTEM .......................................................................................... 38
TROUBLESHOOTING .................................................................................................................................... 39
FREQUENTLY ASKED QUESTIONS (FAQS) .................................................................................................... 41
Page | 4
GLOSSARY
CAREGIVER
CADENCE
The steps you take per minute, as measured by the CHIRP System
An adult family member, friend, or personal assistant who can help you with your care
and who you allow to have access to your personal and health information.
CHIRP
This stands for Canary Health Implanted Reporting Processor. This is the software and
electronics found within your CTE knee implant. The software and electronics collect
information on your activity level and quality of movement after you receive your new
knee.
CTE
Canary Tibial Extension
DISTANCE
This is how far you have walked in miles on a given day as measured by the CHIRP
System.
EHR
Electronic Health Record. This is the medical information stored electronically by your
doctor’s office and in your Patient Account. You have the right to access this
information.
GAIT
Refers to the manner or way in which a person walks.
HOME BASE STATION
The unit placed in your home which collects activity information from your CTE knee
implant and sends it to a website, where you and your doctor view it.
PATIENT DASHBOARD
Your page where you log in on the Canary Medical website to view information
collected by the CTE and CHIRP System. Please note that the data collected each day
will not be available on the dashboard until the following day.
PROSTHESIS
Medical term for your knee implant.
RANGE OF MOTION
This is a measure of how much your knee can bend and straighten.
Page | 5
STEP COUNT
The number of steps you take during the most active part of your day.
STRIDE
The amount of distance covered between the time when one foot hits the ground and
then the same foot hits the ground again.
USB CABLE
A cable shipped with your Home Base Station that allows it to connect with your
computer.
TKA
Total Knee Arthroplasty
Also called total knee replacement. This is the replacement of your natural knee joint
with an implant (prosthesis).
WALKING SPEED
This is a measure of how far you walk over a period of time.
Page | 6
INTRODUCTION
With the help of your doctor, you have decided to have a procedure called a total knee
arthroplasty (TKA). TKA is also called total knee replacement. The TKA procedure
replaces diseased or damaged parts of your natural knee joint with an implant
(prosthesis) device.
The implant you will receive is a Zimmer Biomet Persona® Personalized Knee System with
a Canary™ Tibial Extension (CTE).
The CTE is a part of the knee implant that will help to stabilize your new knee. It also
contains software and electronics that will collect information about your activity level
and how well you walk immediately after surgery and over a long period of time.
The software and electronics are part of a technology package called the Canary Health
Implanted Reporting Processor (CHIRP). CHIRP allows information about how you are
walking to be collected from your CTE implant. The data is processed and transmitted to
a secure website where both you and your doctor will be able to view information about
your activity level on your respective Dashboards. This helps you and your doctor to
monitor your activity level, without the need for an office visit. This may help you and
your doctor do a better job of monitoring the health of your knee.
There are several steps in the process of receiving your knee implant and using your CHIRP
System. They are generally outlined below:
1. Meet with your doctor and decide to go forward with TKA surgery, including the
CTE implant.
2. Use the Quick Start Guide your doctor’s office gave you, and this manual, to create
a patient account. You must create an account prior to surgery to receive the
Canary CTE Implant.
3. Receive a Home Base Station and connection accessories shipped from Canary
Medical. Along with your knee implant, this equipment is part of the CHIRP
System.
4. Set up your Home Base Station using the instructions in this manual and a Quick
Start Guide shipped with the Home Base Station.
5. Have your TKA surgery.
6. Return home from the hospital or rehabilitation center.
Page | 7
7. Confirm your Home Base Station is still working correctly by checking the green
light on the unit.
8. After you return home, the Home Base Station will automatically start collecting
and sending information from your CTE implant to the secure Canary Medical
website.
9. View your activity on your Patient Dashboard, located on the Canary Medical
website. You can start viewing data on the third day after your procedure.
10. Follow up with your doctor as directed.
The Quick Start Guide and this manual show you how to create your patient account and
set up your Home Base Station so your CTE implant can start to collect information on day
two after your surgery.
This manual also describes how to use the Internet to view the data collected by your
implant.
Finally, this manual answers other questions you may have about your knee implant with
the CHIRP system.
Please read this information carefully. If you have additional questions about your knee
replacement procedure, your knee implant with CTE, or the CHIRP system, please contact
your doctor.
Page | 8
SETTING UP YOUR PATIENT ACCOUNT
Before you have your TKA surgery, follow the steps and screen shots below to set up your
patient account. After you complete your account setup, a Home Base Station and
connection accessories will be shipped to your home.
1. After leaving your doctor’s office, check your email for a message containing
instructions on how to set up your patient account.
2. In the e-mail, click on the link, as circled in the screen shot example below.
Page | 9
3. As shown in the screen shot example below, your username should already be
filled in for you. If it is not, enter your email address. Your email address is your
username.
Create your password. Your password must be a minimum of 8 and a maximum of
15 characters.
It must include at least 1 upper case letter, 1 lower case letter, 1
number, and 1 special character. Click “Save.”
NOTE: Save your username and password for future login. There is a space on page
3 of this manual to write it down. You will need it to set up your Home Base Station
and view your Patient Dashboard.
4. You will then see a screen that looks like the one below. Enter the username and
the password you just created. Click “Login.”
Page | 10
5. You should now be at the Terms and Conditions page, as shown in the screen shot
example below. Read the Terms and Conditions for receiving a CTE with CHIRP.
To continue with registration, you must Agree to the Terms and Conditions.
You are not required to agree. You can click “Disagree” and your doctor can
provide you with a standard knee implant without the CTE and CHIRP System.
You can also change your mind at any time before having your surgery.
If you agree to the Terms and Conditions, click “Agree.”
Page | 11
6. You should now be at the Patient Consent page, as shown in the example screen
shot below. To continue with registration, you must provide your consent to the
sharing of your personal health information with Canary Medical and authorized
health care personnel.
You are not required to consent. You can click “Cancel” and your doctor can
provide you with a standard knee implant without the CTE and CHIRP System.
You can also change your mind at any time before having your surgery.
If you wish to give your consent, click the “Yes” buttons next to “Canary Medical”
and “Practice.” Then click “Accept.”
Page | 12
7. You should now be at the “My Profile” Welcome screen as seen in the screen shot
below. Read the information and click “Next.”
Page | 13
8. You should now be at the Personal Information screen. There are 3 areas on this
screen where you need to fill in your information, as shown in the example screen
shots below. They are Patient (you) Details, Emergency Contact, and Caregiver
Details.
If you are under 18 years of age, your parent or guardian will need to
NOTE:
complete this information.
Each field with a red asterisk next to it is required information that must be added
before you can move on to the next screen. Click on each tab and provide the
required information. Then click “Save & Next.”
Page | 14
Page | 15
9. You should now be at the General Information screen as shown in the example
screen shots below. Fill out the information in the boxes. When you are finished,
click “Save & Next.”
Page | 16
You should now be at the Confirmation screen as shown in the example screen shot
below. Click on the arrows on each tab to review all of the information you have input to
confirm it is correct. When you are finished, click “Save & Next”
Click on down arrows
to review information.
Page | 17
10. You should now be at the Patient Dashboard screen as shown in the example
screen shot below. This confirms your patient account has successfully been
created, and Canary Medical will ship a Home Base Station to the address you
provided. Click “OK.” You are finished setting up your account.
Please note: At this point, it is normal for the screen to display “No Data Found”
as you have not yet had your surgery. Data will be available on your Patient
Dashboard starting on day 3 after your surgery.
Page | 18
YOUR KNEE IMPLANT WITH CANARY TIBIAL EXTENSION & CHIRP
SYSTEM
During your surgery, your surgeon will replace your natural knee joint with a knee
implant (prosthesis). Your prosthesis will include a Canary Tibial Extension (CTE) with
CHIRP system. The CTE with CHIRP System does the following:
Helps to stabilize your new knee joint
Collects mobility data to help you and your doctor remotely monitor your
progress in recovery and long-term knee health.
The software and electronics inside the CTE, along with an exterior Home Base Station
unit, collects movement information from your implant. This information helps you and
your doctor monitor your activity level after surgery. You can view information about
your activity level by going on the Internet and viewing your Patient Dashboard. Your
doctor can view the Physician Dashboard.
YOUR KNEE IMPLANT WITH CTE & CHIRP COMPONENTS
The picture below shows how the CTE connects to the Zimmer Biomet Persona
Personalized Knee System’s tibial plate component.
CTE
Zimmer Biomet
tibial plate
CHIRP system software,
electronics, and battery
are located in the
interior of the CHIRP
TKA Assembly.
Page | 19
YOUR CHIRP HOME BASE STATION
To enable transmission of your CTE data to the Canary Cloud for analysis and display to
you and your Doctor, a Home Base Station, USB Data and Power Cable, and Wall Plug
Adapter will be shipped to you after you set up your patient account. Instructions for
setting up your Home Base Station are on the following pages.
Page | 20
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1. Use the USB Cable to connect the Home Base Station to your computer as shown below:
USB
Connection
Page | 22
2. On your computer, go to the Canary Medical Website (www.canarymedical.com).
3. Select the “Login” button.
4. The Canary Patient Portal Login screen will appear.
5. Log in using your Canary Username (your email) and Password.
Reminder: You set up your username and password when you set up your Canary account.
6. Click “Setup Base Station” as circled in the picture below.
Page | 23
7. You should be at the Microsoft App Store as shown in the picture below. Click “Get” to
download the free Base Station Setup Tool App.
8. You will see the following screen. Click “Open Microsoft Store.”
Page | 24
9. You will see the screen below. You do not need to create an account. Click the “x” as circled in
the picture below.
10. Click “Install” as shown in the picture below.
Page | 25
11. You will see the following screen while the Base Station Setup Tool is downloading.
12. When the download is finished, you will see the following screen. Click “Launch.”
Page | 26
13. You should be at the screen below. Enter your username and password.
Page | 27
14. You will see the following screen. Read the information and click “Next.”
Page | 28
15. You will see the following screen. Read the directions and ensure you have connected your
equipment correctly. Click “Next.”
Page | 29
16. Enter your home Wi-Fi Network Name (SSID) and Wi-Fi Password and click “Next” as shown in
the picture below.
Page | 30
17. When you see the screen below, your Base Station is successfully connected. Click “Next.”
Page | 31
18. Disconnect the USB end of the Cable from your computer. Leave the other end plugged into
the Base Station.
Follow the instructions on the screen as shown in the screen shot below.
If you need help, the pictures on the following pages show you how to make the connections
described on the screen.
When you have completed all the steps, click “Finish.” You’re all set!
Page | 32
This photo shows how to plug the USB end of the Cable into the Wall Plug Adapter.
Plug USB
into Wall
Adapter
Place the Home Base Station, connected as shown below, in a location within 6 feet
of your sleeping area and plug it into a wall outlet.
Plug into a wall outlet within 6
feet of where you sleep
Page | 33
The light on the front of the Home Base Station will be yellow as it establishes the connection
with your Wi-Fi and the Canary website and will turn to a solid green when it is successfully
connected.
OPERATING YOUR HOME BASE STATION
Make sure your Home Base Station is correctly located in its permanent location within 6 feet of your
typical sleep location, plugged in to a wall outlet, and connected to your home Internet system. That’s
all you need to do.
Your CHIRP System with Home Base Station will operate automatically without further input from you.
After your surgery, your system will collect, store, and transmit information from your implant. Your
doctor will be able to view information about your activity levels beginning the third day after surgery,
and so will you. Just go to your Patient Dashboard on the Canary Medical website.
Page | 34
YOUR PATIENT DASHBOARD
Your new knee implant with CHIRP System allows you to monitor your activity level after
your surgery. You can use your computer to go on the Internet and view your Patient
Dashboard. Just log in to your account with the username and password you set up
earlier, and you will see your Patient Dashboard.
You will be able to see the following information:
The number of steps you take (your Step Count)
The distance you have walked (your Distance)
How much your knee bends and straightens (your Range of Motion)
How fast you walk (your Walking Speed)
The amount of distance you cover between the time when one foot hits the
ground and then the same foot hits the ground again (Your Stride)
How many steps you take per minute (your Cadence)
The CHIRP system is not intended to provide real time data like a smart watch or your
smart phone. Rather, it collects information over the course of a day and analyzes it
while you are asleep. The following day, you and your doctor will be able to see the
information on your dashboards.
Your CTE implant has the ability to store 30 days of data. Therefore, if your Home Base
Station connection is temporarily lost or you are traveling for less than 30 days without
a Home Base Station, the full amount of data will be uploaded 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 your Home Base Station and the Canary Cloud is made.
Your CTE implant has been programed to collect data according to the following
schedule:
Time Period
Data Collection
Day of surgery and day after surgery
No data collection
Day 2 to Day 365
Data is collected daily
Page | 35
Time Period
Data Collection
Year 2
30 consecutive Days/Quarter
Years 3 and beyond
30 consecutive days starting on the anniversary of
your surgery date
When the CTE is not collecting data, it is in a low power mode to conserve battery
power. When viewing your 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.
The picture on the following page shows an example view of a Patient Dashboard.
Page | 36
Page | 37
MAINTAINING YOUR CTE WITH CHIRP SYSTEM
Cleaning
Storing
Once a week, wipe the surface of the Base Station unit with a dry, soft cotton cloth. Do
not use wet cloths or paper towels and do not immerse the Base Station unit in water.
There are no special storage instructions for the Base Station. The Base Station should
remain plugged in within 6 feet of where you typically sleep so it can regularly receive
activity information from your implant.
What to do if your CHIRP System equipment stops working
If your equipment shows errors that you cannot fix by using the information in this
manual, or if it stops working completely, contact Canary Medical at the phone number
below:
1-800-123-9876.
How to Dispose of the CHIRP System equipment
Do not dispose of the Base Station in household trash. Call Canary Medical at the phone
number below for instructions:
1-800-123-9876.
Page | 38
TROUBLESHOOTING
The table below lists some problems you might have with your CHIRP System and
suggested actions you can take to try to fix the problem. If you have a problem with the
system that is not listed here or that cannot be fixed with the information provided, call
your doctor or Canary Medical.
If the problem you are experiencing is with your health (such as pain or limited mobility)
and not with the operation of your CHIRP System, call your doctor.
If you are experiencing a health emergency, call 911.
Problem
Action
The light on the Base Station is
not lit.
I can’t reach the Canary Medical
website.
I can’t log in to my Patient
Account.
I can’t see my Patient Dashboard
information.
The light on the Base Station is
solid red.
Make sure the USB Power and Data Cable is
connected to the Base Station and Wall Plug
Adapter. Make sure the Base Station is plugged
into the wall outlet.
Check your home Internet and make sure you are
connected to the Internet. If connected and still
can’t reach the Canary Medical website, try again
later and/or contact Canary Medical at:
1-800-123-9876
Check your username and password.
You will only see information on your Patient
Dashboard beginning 3 days after your surgery.
If your information is still not on your Patient
Dashboard at this timepoint, check your Base
Station to make sure the light is solid green. If the
light on your Base Station is green, check your
Patient Dashboard information again in 24 hours.
Unplug the Base Station, wait 5 seconds, and plug
it back in. If the light remains solid red, contact
Canary Medical at :
1-800-123-9876.
Page | 39
Problem
Action
The light on the Base Station is
solid yellow.
Check your home Wi-Fi signal to make sure it is
operating. This can be done by checking your
smart phone’s Wi-Fi signal in your bedroom next
to your Home Base Station.
Wait 24 hours and recheck the light on the Home
Base Station.
If it is still solid yellow, reconnect the Home Base
Station to your computer, and go through the
Base Station Setup Process starting on page 22 of
this manual.
Make sure your home Internet is working. Reset
your Wi-Fi router if needed. Wait 24 hours and re-
check the light on the Home Base Station. If it is
still blinking yellow, contact Canary Medical at
1-800-123-9876
The light on the Base Station is
blinking yellow.
Page | 40
FREQUENTLY ASKED QUESTIONS (FAQS)
How do I know my CHIRP System is connected to the Internet?
Check to make sure the green light on the Base Station unit is lit. This shows that your
system is connected to the Internet.
How do I know my CTE system is transmitting?
Log in to your Patient Dashboard after surgery. If the information being displayed is
from the past 24 hours, you can be sure your CTE is transmitting.
How long will my CHIRP system collect information from my implant?
At least ten years.
What if my Internet connection goes down or is interrupted?
Ensure your Internet is re-established and working properly. Check to make sure the
green light on the Base Station unit is lit. This shows that your system is connected to
the Internet.
What if I get a new computer?
A new computer will not affect your CTE with CHIRP System. Navigate to the Canary
Medical website and login to your Patient Dashboard with your Username and
Password.
Will my system stop working if I fall or injure the knee that has the implant?
After the fall or injury, wait 24 hours and log in to your Patient Dashboard. If the
information being displayed is from the past 24 hours, you can be sure your CTE is still
working properly. If you are concerned or in pain, call your doctor.
How do I get help if I have questions about my implant?
If you have questions about your TKA surgery or the knee that has the implant, call your
doctor.
Page | 41
How do I get help if I have questions about my Home Base Station?
Contact Canary Medical.
Who can view my personal health information that is transmitted by the implant?
Your doctor and their qualified staff can view your personal health information
transmitted by the implant. You can also view your information on your Patient
Dashboard, located on the Canary Medical website. For your security, don’t share your
username and password with anyone you don’t want to be able to view your personal
health information.
Is my health information secure?
Yes, the information from your implant is transmitted over a secure and encrypted
connection and stored securely in the Canary Medical database.
Page | 42
WHO SHOULD NOT GET TKA SURGERY?
The following people should not get TKA surgery:
People who have had a previous infection, either in the affected knee or in another
part of the body, that could affect the new implant
People whose bone structure cannot support the new implant. This can be due to
osteoporosis, bone loss, bones that are not fully formed, degeneration of the knee
joint, etc.
The Zimmer Biomet Persona Personalized Knee System is not 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
Patients who have rheumatoid arthritis (RA) accompanied by an ulcer of the skin or a
history of recurrent breakdown of the skin should not get TKA 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.
WHO SHOULD NOT GET THE CANARY TIBIAL EXTENSION?
You should not receive the CTE if you are undergoing procedures or treatments using
ionizing radiation. These treatments or procedures could damage the CTE.
The CTE Implant is longer than some other knee implants. Some patients can’t get the
CTE because they don’t have enough space inside their bones for the implant to fit. The
implant must fit properly to avoid bone damage. Your doctor will take measurements
to ensure the CTE will work with your body.
Page | 43
DOES KNEE IMPLANT SURGERY HAVE RISKS?
All surgery has risks. Before your surgery, your doctor will explain the risks and benefits
of your total knee replacement.
HOW CAN KNEE IMPLANT SURGERY HELP ME?
Knee implant surgery may help you to move and walk better. After recovery, you may
have less pain, since your damaged or injured knee joint will be replaced with a new
implant.
WHAT TO EXPECT AFTER YOUR TKA SURGERY WITH CANARY TIBIAL EXTENSION
The CTE with CHIRP System will provide you and your doctor with information about
your activity levels after your surgery. The activity level may help you and your doctor
to know if your movement is what is anticipated by your doctor.
If you have questions about recovering after TKA surgery, such as how much pain to
expect, how long it will take you to get better, and what medications you might need,
talk to your doctor.
WILL MY IMPLANT HAVE TO BE REPLACED?
Knee implants do eventually wear out for some patients, and there is always the
possibility that your knee implant will have to be replaced. Talk to your doctor if you
have questions or concerns about how long your implant should last.
CARING FOR YOUR HEALTH AFTER YOUR TKA
After your TKA procedure, it’s important to continue to take care of yourself. Do the
following to be as healthy as possible and give yourself the best chance for a successful
recovery:
Follow your post-surgery instructions about diet, medications, and exercise.
Keep a regular schedule of rehabilitation exercises as directed by your surgeon or
your doctor.
Make sure you keep up with all of your follow-up appointments with your
surgeon or your doctor.
Get regular general health checkups.
Page | 44
Before having any medical or dental tests or treatments, tell your care providers
that you have a Canary implant.
Some medical procedures use medical equipment that introduces electrical
currents into your body. These procedures may not be safe with the Canary
Medical CTE implant. After your surgery, make sure you carry your implant card.
Inform your health care provider that you have a Canary Medical CTE implant
before any medical procedures using medical equipment.
CAN I TRAVEL WITH MY CTE AND CHIRP SYSTEM?
You can travel with your CTE and CHIRP System.
Metal Detectors and Security Systems
Many knee implants will set off the metal detector at airports and other secure
buildings. Tell the security agent that you have a knee implant before passing through
the metal detector. It’s also a good idea to carry your implant ID card with you.
Your Home Base Station
Your CTE stores thirty days of information within the implant itself, so you don’t have to
worry about taking your Home Base Station with you on most trips. When you get
home, the CTE and Home Base Station will transmit the stored information to your
doctor and your Patient Dashboard.
If you are going to be traveling for more than thirty days, the implant will keep collecting
information. However, it will start to overwrite information that is more than thirty
days old. Make a note of your travel dates, so you will know why your Patient
Dashboard will not show information during that time period.
If you spend part of the year away from home, for instance, if you have a second
summer or winter home, simply take your Home Base Station and accessories with you
to your new location. Repeat the setup steps in this manual and you are all set. Your
CTE implant will transmit as usual.
What if I Move?
If you move, just take your Home Base Station and accessories with you to your new
home. Repeat the setup steps in this manual and you are all set. Your CTE implant will
transmit as usual.
Page | 45
Manufactured for:
Canary Medical, LLC.
2710 Loker Ave. West
Suite 350
Carlsbad, CA 92010
www.canarymedical.com
E-mail: support@canarymedical.com
Customer Assistance: 1-800-123-9876
PN. K01-HBS-300003, Rev2
Page | 46
| 1 2 | User Manual II | Users Manual | 32.30 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.FCC RF Exposure statement
| 1 2 | External Photos | External Photos | 147.78 KiB | July 30 2021 / January 26 2022 | delayed release |
| 1 2 | Label | ID Label/Location Info | 628.81 KiB | July 30 2021 |
Canturio™ - TE Home Base Station
For Use with Canturio™ - TE
IP22
FCC ID:
2AYAJ-BS1
(01)00860003118320
(21)123456
*+H124435570001141A*
*+$123456A20A.*
(833) 722-6279
A
Made in Canada
| 1 2 | 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 2 | Test Setup photos | Test Setup Photos | 1.29 MiB | July 30 2021 / January 26 2022 | delayed release |
| frequency | equipment class | purpose | ||
|---|---|---|---|---|
| 1 | 2021-07-30 | 2402 ~ 2480 | DXX - Part 15 Low Power Communication Device Transmitter | Original Equipment |
| 2 | 402 ~ 405 | TNB - Licensed Non-Broadcast Station Transmitter |
| app s | Applicant Information | |||||
|---|---|---|---|---|---|---|
| 1 2 | Effective |
2021-07-30
|
||||
| 1 2 | Applicant's complete, legal business name |
Canary Medical USA LLC
|
||||
| 1 2 | FCC Registration Number (FRN) |
0030229884
|
||||
| 1 2 | Physical Address |
2710 Loker Ave West Suite 350
|
||||
| 1 2 |
2710 Loker Ave West
|
|||||
| 1 2 |
Carlsbad, CA
|
|||||
| 1 2 |
United States
|
|||||
| app s | TCB Information | |||||
| 1 2 | TCB Application Email Address |
V******@nemko.com
|
||||
| 1 2 | TCB Scope |
A2: Low Power Transmitters (except Spread Spectrum) and radar detectors operating above 1 GHz
|
||||
| 1 2 |
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 2 | Grantee Code |
2AYAJ
|
||||
| 1 2 | Equipment Product Code |
BS1
|
||||
| app s | Person at the applicant's address to receive grant or for contact | |||||
| 1 2 | Name |
N******** Y****
|
||||
| 1 2 | Title |
Senior Director RA/QA
|
||||
| 1 2 | Telephone Number |
76044********
|
||||
| 1 2 | Fax Number |
76044********
|
||||
| 1 2 |
n******@canarymedical.com
|
|||||
| app s | Technical Contact | |||||
| n/a | ||||||
| app s | Non Technical Contact | |||||
| n/a | ||||||
| app s | Confidentiality (long or short term) | |||||
| 1 2 | 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 2 | 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 2 | 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 2 | Is this application for software defined/cognitive radio authorization? | No | ||||
| 1 2 | Equipment Class | DXX - Part 15 Low Power Communication Device Transmitter | ||||
| 1 2 | TNB - Licensed Non-Broadcast Station Transmitter | |||||
| 1 2 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | OR Base Station | ||||
| 1 2 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
| 1 2 | Modular Equipment Type | Does not apply | ||||
| 1 2 | Purpose / Application is for | Original Equipment | ||||
| 1 2 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | Yes | ||||
| 1 2 | 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 2 | Grant Comments | Power Output listed is EIRP. The antenna(s) used for this transmitter must be installed to provide a separation distance of at least 20 cm from all persons and must not be co-located or operating in conjunction with any other transmitter, except in accordance with FCC multi-transmitter product RF exposure procedures. | ||||
| 1 2 | Is there an equipment authorization waiver associated with this application? | No | ||||
| 1 2 | 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 2 | Firm Name |
Element Materials Technology Irvine
|
||||
| 1 2 | Name |
R**** W****
|
||||
| 1 2 | Telephone Number |
503-8********
|
||||
| 1 2 | Fax Number |
503-6********
|
||||
| 1 2 |
r******@element.com
|
|||||
| Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
| 1 | 1 | 15C | 2402.00000000 | 2480.00000000 | |||||||||||||||||||||||||||||||||||||
| Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
| 2 | 1 | 95I | 402.00000000 | 405.00000000 | 0.0000046 | 52.0000000000 ppm | 245KF1D | ||||||||||||||||||||||||||||||||||
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