ADDITIONAL INFORMATION FOR CLINICIANS*
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Below you’ll find an overview of Canary Clinician Services and answers to questions you might have.
What are Canary Clinician Services?
What elements does Canary Clinician Services consist of?
• The canturio®te device is integrated into the tibial extension (te) of Persona IQ® prosthetic knee implanted in the patient during TKA surgery. This collects data from accelerometers and gyroscopes in the device and then transmits that day’s data to the patient’s Home Base Station located in their bedroom while they sleep.
• The Canary Home Base Station is a small black box with LED lights that the patient will set up and connect to their home Wi-Fi prior to surgery. After surgery, the canturio®te device will communicate activity and gait data to the Home Base Station while they sleep, which then securely transfers that data to a secure server for analysis and viewing.
• The O.R. Base Station is what the OR Staff and/or the Zimmer Biomet Representative will use the day of surgery to “wake up” canturio®te device(s), test and verify their function before, during, and after surgery.
• canturio®te surgical instruments and instructions are specifically designed for use with the canturio®te system together with the Persona IQ® surgical instruments during Persona IQ® Total Knee Arthroplasty.
• Canary™ Cloud is where patient-specific data is analyzed on the Charm™ platform and converted to gait metric activities that matter to you and your patients.
• The Clinician Dashboard is your web-based application for initiating patient account setup, pairing devices with patients and is also where you will view patient data. Access to Canary Remote Patient Care Charm™ platform will be provided separately and may be used by the HCP to help comply with CMS documentation requirements for Remote Patient Monitoring (RPM).
Canary Canturio® tibial extension (te) is used with the Persona IQ® The Smart Knee® Total Knee Arthroplasty.
canturio®te contains sophisticated sensors that generate detailed data on your patient’s activity level between office visits during TKA post-surgical care. Because canturio®te is implanted, patient compliance is virtually 100%, which means you can count on having data to inform your care.
This objective kinematic data helps you and your patient manage their recovery. Canary Medical also provides practice management to meet the requirements to make your remote patient monitoring reimbursable by Medicare CPT Codes.
canturio®te virtually guarantees patient compliance, delivers unprecedented data to inform your care, and enables new workflow efficiencies for your practice.
Data collection and security
When is data collected?
• canturio®te collects data over the course of the day and uploads it to our HIPAA-compliant servers while the patient sleeps for additional processing. The following day, you and your patient will be able to see your patient’s activity and gait data in your respective dashboards.
• Up to 30 days of data can be stored by the canturio®te. This means that your patient may be away from their Home Base Station for several nights without losing data.
Is the Canturio® system always on?
• canturio®te implant has been programed to collect data according to the following schedule:
• When canturio®te is not collecting data, it is in a low power mode to conserve the battery.
What data is collected?
• The canturio®te device collects data from a 3D accelerometer, 3D gyroscope, and a pedometer inside the implant. This raw data is converted into information specific to the patient’s implant and recovery by Canary algorithms. You and your patient view data on your respective dashboards.
• For the Persona IQ® knee application of the canturio®te technology, patient raw data is used to provide you and your patient with metrics on activity such as step count and distance traveled and metrics on gait including range of motion, average walking speed, cadence, stride length.
Is patient data secure?
• Yes. Data from canturio®te implants and the Home Base Station are transmitted over a secure and encrypted connection and stored securely in the Canary Medical database, which uses secure, HIPAA-compliant servers.
• The patient, you and your qualified staff can view patient health information from your respective password-protected Canary accounts.
What you and patients can expect before, during and after surgery
What can you and patients expect before surgery?
• Prior to implanting the canturio®te technology, there are few relatively easy steps clinicians can take. These include:
• Create a Canary Clinic account and clinician sub-accounts prior to the first canturio®te surgery.
• Setting up your clinician account will allow you to enter patients, surgical dates, hospital information, etc.
• First confirm the patient has access to a computer with USB connection and home wireless Internet access. If so:
• Entering a patient and surgical date sends an account setup email to the patient.
• Prior to getting an implant with the canturio®te technology, there are few relatively easy steps patients can take. These include:
• Create their Canary patient account
• Patient account setup will be initiated by you, the clinician.
• When you enter a patient and scheduled surgery into your clinician account, an automated email will be sent to the patient to initiate their respective account setup.
• Patients can use the Canary Quick Start Guide – Patient Account Setup to finish setting up their account prior to surgery.
• Set up their Home Base Station
• The patient will receive a Home Base Station at the clinician’s office to connect to their home WiFi prior to surgery.
• This is covered by the Canary Quick Start Guide – Home Base Station Setup document.
What can you expect during surgery?
• Relative to the Persona® The Personalized Knee® system prosthesis, the overall TKA surgery is relatively unchanged for the Zimmer Biomet Persona IQ® prosthetic.
• The operating room (OR) tooling kit used to implant a canturio®te is shown below and contains the special instruments and instructions for use to support TKA surgeries using the Persona IQ® prosthetic knee implant.
• Minor additional steps specific to the Persona IQ® knee include:
• During pre-operative preparation you’ll use the O.R. Base Station to wake and test canturio®te sensors.
• During surgery, you’ll use the O.R. Base Station to activate the canturio®te implant after it is inserted into the Patient’s tibia. This step ensures the implanted device is active and will be transmitting patient data following surgery.
• For more information on the pre-op and intra-op steps that use the O.R. Base Station and associated software please refer to the Operating Room Base Station QuickStart Guide.
What can you and patients can expect after surgery?
• Beginning day two after surgery, canturio®te will begin collecting patient activity and gait data. This data will be uploaded at night by the Patient’s Home Base Station, processed in Canary Medical’s secure cloud, and will be displayed a day in arrears on the patient and clinician dashboards.
• As a clinician, you will automatically get patient data, without any actions on your patient’s part.
• Because the Canary canturio®te device is implanted and uses a battery that can supply power for up to 20 years, you are almost guaranteed, effortless adoption by patients. Unlike a wearable that requires patient buy-in and behavioral adoption, the Canary canturio®te provides unbiased data, automatically, so you can count on knowing you’ll have the data to help critically evaluate how your patient is recovering and can personalize your care plan to keep them on track.
• Regarding patient compliance of wearable vs. implanted monitoring technology… a 2017 study by Kuwik, et al. measured compliance of a wearable monitoring device for TKA. They found that over the first 90 days about 25% patients logged no data at all, about 25% collected data on 80 or more days, the remaining 50% collected data on some days with compliance falling off over time. The Canary sensor is embedded, which means it goes everywhere the patient goes and is all but guaranteed to generate a meaningful set of patient data.
• Your Clinician Dashboard, allows you to monitor patient activity level and gait after surgery. This data will provide visibility to patient kinematics that will help you know if their movement is aligned with your post-operative expectations.
• Specifically, you’ll be able to see:
• Step Count – the number of steps the patient takes
• Distance – the distance the patient has walked
• Functional Knee Range of Motion – how much their knee bends and straightens relative to the ground
• Tibial Range of Motion – the angle of their tibia relative to the ground
• Walking Speed – how fast they walk
• Stride Length – The amount of distance they cover between the time when one foot hits the ground and then the same foot hits the ground again
• Cadence – how many steps they take per minute
• You’ll have newfound visibility to clinically-relevant data on implant function and patient recovery. You’ll be able to monitor your patient’s recovery and rehabilitation remotely, but without compromise. You’ll be able to use data to inform your care plan to help affect patient recovery and long-term health.
• Patients can also access their data, if they chose to. They don’t have to, but it could be helpful in monitoring and affecting their own recovery.
Canary data, now and in the future
What data does canturio®te collect?
• canturio®te collects raw data from accelerometers and gyroscopes in the device, which is part of the Persona IQ® implant.
• Raw data from a canturio®te device is sent to the Canary Cloud where proprietary algorithms convert this raw data to the activity and gait metrics you and patients see on your respective dashboards.
• Step count is captured directly by the sensor. To generate the other, more human-friendly metrics, we use our algorithms to translate raw inertial measurement unit (IMU) data into Canary Medical Gait Parameters.
• Your Clinician Dashboard will show you an average of a given day’s metrics for a selected patient. Again, these include:
• Step Count – the number of steps the patient takes
• Distance – the distance the patient has walked
• Functional Knee Range of Motion – how much their knee bends and straightens relative to the ground
• Tibial Range of Motion – the angle of their tibia relative to the ground
• Walking Speed – how fast they walk
• Stride Length – The amount of distance they cover between the time when one foot hits the ground and then the same foot hits the ground again
• Cadence – how many steps they take per minute
• We believe that more insights and metrics can be derived from canturio®te raw data than is currently displayed on Patient and Clinician Dashboards. As the cumulative Canary data set grows for any one type of implant, Canary will be looking to derive and pursue FDA commercial market clearance to share more data-derived insights with clinicians.
Practice management support
What can you and patients can expect after surgery?
• While the COVID-19 pandemic has made remote patient monitoring more common, we realize that this is still somewhat new territory for many clinicians, especially surgeons.
• Canary Clinician Services makes it easy for clinicians to actually use the remotely acquired data as an integral part of patient monitoring and care.
In addition to unprecedented patient data, Canary provides practice management services through its Canary™ Charm™ platform that include reports designed to support clinical decision making and reimbursement based on the remote patient monitoring (RPM) data.
• The Center for Medicare/Medicaid Services (CMS) has published codes that allow clinicians to be reimbursed for RPM services.
• The Canary solution helps you intelligently navigate incorporation of these RPM CPT billing codes into your workflow to get reimbursed for the monitoring and care you and your staff are providing your patients.
• You’ll be able to use the patient data, visible on your Clinician Dashboard, to create a personalized care plan that is tied to billable CPT codes.
• You’ll know if your patients are doing their PT and progressing as they should, and you’ll also know if they’re not by reviewing their activity and gait data. You can adjust and customize your care plan accordingly and utilize the billing codes to get reimbursed for your remote patient care delivery.
STILL HAVE QUESTIONS?
* WARNING – The kinematic data from this device has not been demonstrated to have clinical benefit. It is not intended to be utilized for clinical decision-making, and no data has been evaluated by FDA regarding clinical benefits.