canary BS1 OR Base Station Instruction Manual

BS1 OR Base Station
Instruction Manual

Canary Tibial Extension with CHIRP System

Patient Manual

Read this manual carefully. If you have additional questions after reading this manual, contact your doctor.

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.)

Your Canary Medical Patient Registration Information

Website|
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Username|
Password|

GLOSSARY

CADENCE
The steps you take per minute, as measured by the CHIRP System
CAREGIVER
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 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 login on to 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
The medical term for your knee implant.
RANGE OF MOTION
This is a measure of how much your knee can bend and straighten.
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 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.

INTRODUCTION

With the help of your doctor, you have decided to have a procedure called 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 bout 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 does 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.
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.

SETTING UP YOUR PATIENT ACCOUNT

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 screenshot example below./
   

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.”
   

5. You should now be at the Terms and Conditions page, as shown in the screenshot 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.”

6. You should now be at the Patient Consent page, as shown in the example screenshot 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.”

7. You should now be at the “My Profile” Welcome screen as seen in the screenshot below. Read the information and click “Next.”

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 screenshots below. They are Patient (you) Details, Emergency Contact, and Caregiver Details.
   NOTE: If you are under 18 years of age, your parent or guardian will need to 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.”

   ---

9. You should now be at the General Information screen as shown in the example screenshots below. Fill out the information in the boxes. When you are finished, click  “Save & Next.”
   You should now be at the Confirmation screen as shown in the example screenshot 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”

10. You should now be at the Patient Dashboard screen as shown in the example screenshot 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.
    

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 a 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, collect 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 a 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.

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.

HOW TO SET UP YOUR CHIRP HOME BASE STATION

Make sure your package contains the items shown below.

You must have a computer with at least one USB connection port as shown in the picture below.

You must also have the following

• Windows 10 or higher operating system
• A wireless Internet connection
• Microsoft Edge or Google Chrome browser
• Your home Wi-Fi Network Name (SSID) and Wi-Fi Password
• Your Canary Username and Password that you set up when you created your patient account

1. Use the USB cable to connect the Home Base Station to your computer as shown below:
   

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.

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.”

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.
    

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.”

13. You should be at the screen below. Enter your username and password.

14. You will see the following screen. Read the information and click “Next.”

15. You will see the following screen. Read the directions and ensure you have connected your equipment correctly. Click “Next.”
    

16. Enter your home Wi-Fi Network Name (SSID) and Wi-Fi Password and click “Next” as shown in the picture below.

17. When you see the screen below, your Base Station is successfully connected. Click “Next.”

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 screenshot 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!
    This photo shows how to plug the USB end of the Cable into the Wall Plug 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.
    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 into 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.

YOUR PATIENT DASHBOARD

Your new knee implant with the 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 do you take per minute (your Cadence)

The CHIRP system is not intended to provide real-time data like a smartwatch or your smartphone. 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 overwrite the oldest data until a connection to your Home Base Station and the Canary Cloud is made.
Your CTE implant has been programmed to collect data according to the following schedule:

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.

MAINTAINING YOUR CTE WITH CHIRP SYSTEM

Cleaning
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.

Storing
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 on the phone the number below for instructions: 1-800-123-9876.

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.

Cable is connected to the Base Station and Wall Plug Adapter. Make sure the Base Station is plugged into the wall outlet.
I can’t reach the Canary Medical website.| 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
I can’t log in to my Patient Account.| Check your username and password.
I can’t see my Patient Dashboard information.| 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.
The light on the Base Station is solid red.| 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.

to make sure it is operating. This can be done by checking your smartphone’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.
The light on the Base Station is blinking yellow.| Make sure your home Internet is working. Reset your Wi-Fi router if needed. Wait for 24  ours and recheck the light on the Home Base Station. If it is still blinking yellow, contact
Canary Medical at 1-800-123-9876

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.

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.

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 an 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 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.

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.
• 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 SYSTEMS?

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 The 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.

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

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