FAQ

When is the Corsano CardioWatch available?

• It’s available now! Please contact us  today if you would like to discuss using the Corsano CardioWatch in your study.

In what countries is the Corsano CardioWatch available?

• Corsano CardioWatch is CE-MDR Certified in Europe. For certificates and registration, please see https://corsano.com/knowledge-base/certificates/. FDA 510(k) is pending. CardioWatch is available in most of the rest of world as an Investigational Device.

What is the battery life of the Bracelet and how long does it take to recharge?

• Corsano CardioWatch 287-2 has a battery life of up to 15 days. The type and number of sensors used, the sampling frequency, and the duration of data collection do impact battery life. Your Corsano account manager can provide a more accurate estimate of battery life based on your study protocolrequirements and corresponding sensor needs.

   In addition, when the Bracelet battery is low, the solution switches to Low Power Mode to help extend Bracelet use as much as possible. The Corsano App will indicate when the Bracelet has entered Low Power Mode. A depleted Bracelet battery takes approximately 3 hours to fully recharge. Corsano Users / Trial Participants can recharge the bracelet at home via a magnetic charger that self-aligns and is USB block compatible. Corsano may also deliver compatible USB chargers.

   Note: Data collection is suspended while the Bracelet is being recharged.

What is the memory storage of the Bracelet?

• CardioWatch 287-2 has an internal memory capacity of up to 8MB. Based on your study protocol, our team will work with you to ensure that wireless data transfers are scheduled at sufficient intervals to capture the data you need.

What are the physical characteristics of the Corsano CardioWatch (thickness, weight, etc.)?

• The Corsano CardioWatch Bracelet weighs 18 grams and measures 24.4 x 40.4 x 9.8 mm. Full specifications can be found in the Leaflet and in the Bracelet IFU .

Can the Corsano CardioWatch be used in adult and youth populations?

• Yes. While CE-MDR Certification has been obtained for use with an adult population, Corsano CardioWatch can be used in adolescent and youth population as an Investigational Device. Various band / strap sizes and strap materials  (e.g., rubber, cloth) are available. Corsano’s Account Manager can assist you with the design and deployment of the Corsano CardioWatch Solution in your clinical trial.

Can sensors be programmed to turn on and turn off at preset times during the study?

• Yes, sensors can be turned On or Off via the Vital Parameters settings for each study in the Research Portal.

   Sensor modes enable a sensor in the bracelet to be turned on at certain time(s) with predetermined data collection configurations and then be turned off again to conserve battery life.

What Vital Parameters are available?

• Pulse Rate, HRV, SpO₂, Respiration Rate, Core Body Temperature, NIBP, Sleep, Activity are currently available.  Please see https://corsano.com/solutions/clinical-information/ for details on specific vtal parameters, sensors, wear positions, and validations.

What Raw Date is available?

• The following Raw Data is available for export in the Research Portal: ACC, PPG G, PPG G/R/iR and BIOZ.

Is the PPG sensor able to obtain accurate measurements on a range of skin types?

• Yes, Pulse Rate, SpO₂ and Respiration Rate were measured using the Multi Wavelength PPG sensor on CardioWatch and were tested on all skin types (Fitzpatrick I to VI). No significant difference in SpO₂ and Respiration Rate accuracy was seen between skin types.

How can I access raw data collected by the Bracelet?

• Raw data is available to researchers in the Corsano Research Portal and via the Corsano Data Access API. Extensive information on the Corsano API can be found at https://developer.corsano.com/rest/intro.

  Need to link Data Access API, Rest API  etc, FAQ Question is where do I access the info on how to transfer data easily?

Will raw data be available for export?

• Data from the bracelet can be transferred / exported securely either via the Corsano App or the Corsano Gateway.

  Note: In many cases, implementing the Corsano SDK in third party applications is also possible. The optimal implementation approach, including timelines and fees can be discussed further with a Corsano Account Manager.

What algorithms are currently available on the Corsano CardioWatch Solution?

• The following algorithms are currently CE-MDR certified:

   

  • Pulse Rate
  • HRV, (Heart rate variability)
  • SpO₂, (Saturation of peripheral oxygen, or oxygen saturation)
  • Respiration Rate
  • Core Body Temperature
  • NIBP, (Non-invasive blood pressure)
  • AF PPG, (via Happitech)
  • AF ECG, (via CardioLyse)
  • Sleep, and
  • Activity

  In Q1 2024 we are planning to add the following algorithms:

  • Gait,
  • EDA (electrodermal activity), and Frailty

Which monitoring intervals are available?

• 1/sec
• 1/10sec
• 1/min
• 1/30min

What continuous raw data is available?

• ACC
• PPG
• BIOZ

Which sampling frequencies are available?

• 25Hz
• 32Hz
• 64Hz
• 128Hz

Are validated and non-validated algorithms managed / treated in the same way?

• Only validated and certified algorithms are available to researchers. New algorithms in development are managed on the Corsano Research Portal in development mode. Such algorithms will be released only after validation is completed.

How can I download large datasets from the Research Portal?

• As described earlier, data is available via the Corsano REST API, which allow for flexibility and the ability to download data quicker.

Can Organisations and / or Researchers get sample data from Corsano to explore what format the output has ?

• See the IFU for the Corsano CardioWatch Study Portal for data formats (chapter 8) and
  this link for sample data.

Can Organisations and / or Researchers use their own algorithms for processing data collected using the Corsano CardioWatch Platform?

• Organizations and / or Researchers may develop your own algorithms within your setting using the analytics and raw sensor data provided via the Corsano REST API.

Can new algorithms be deployed on the Corsano CardioWatch Platform?

• Since the Corsano CardioWatch Platform is a cleared medical device, strict attention to our quality system documentation needs must be maintained. To properly test, document and manage Corsano CardioWatch Platform changes, currently, only Corsano's Data Science team can add and deploy new algorithms to the Platform.

Can other Organisations or Researchers use algorithms developed by my Organisation or my research?

• No. Other Organisations or Researchers cannot use algorithms developed by others.

Where can I get more info on the Corsano REST API?

• Extensive information on the Corsano API can be found at https://developer.corsano.com/rest/intro.

Besides the Bracelet, are there other devices that are connected to the Corsano CardioWatch Platform?

• The following external devices have been integrated in the Corsano CardioWatch 287-2 System:
  • Corsano BP Cuff
  • Corsano Weight Scale
  • MIR Spirometer
  • VivaLNK Auxiliary Thermometer
  • VivaLNK ECG Patch

What security measures have been implemented for the Corsano CardioWatch System?

• The purpose of the Corsano System is to provide a secure and reliable platform for the continuous monitoring of vitals parameters. The system is intended to gather, store, process and utilize data collected by the medical Corsano Bracelet and third-party medical devices.

  Developing and deploying a secure and solid architecture has been crucial for the Corsano CardioWatch Solution. The Corsano Solution must guarantee performance and scalability, and provide Data Security and Privacy. Industry recognized best practices and Amazon Cloud Services (AWS) ensure that necessary threats to data security and privacy are considered.

  Please see https://corsano.com/wp-content/uploads/2023/02/REC-110-1-CardioWatch-287-2-System-Security-Overview-20230206.pdf for details on Corsano System Security.

Are patients involved in design and usability testing?

• Yes, patients are involved in usability testing to provide feedback on usability, comfort, and functionality.

What device validation has been performed on the CardioWatch 287-2 Solution?

• Technical verification and analytical validation with the Corsano CardioWatch and released algorithms have been completed with multiple Clinical Trials:

  • Sleep (validated PPG-Based Sleep Staging – Jul. 2017)
  • A-Fib (CE Class IIa Certified algorithm Preventicus – May 2018)
  • Activity Type, Speed, Cadence (validated VSO ELAN – Nov. 2019)
  • Heart Rate (validated CCN – Mar. 2021)
  • RR intervals (validated CCN – Mar. 2021)
  • Respiration Rate (validated Haaglanden Clinics – Jun. 2021)
  • SPO₂ (validated CMC – Jun. 2022)
  • Core Body Temperature (validated GreenTeg - Mar. 2022)
  • Blood Pressure (Reinier de Graaf - Mar. 2023)
  • Activity (RadBoudMC - Apr. 2023)
  • Cardiac Arrest (in validation RadBoudMC, ErasmusMC, AMC - Dec. 2024)

   Please see https://corsano.com/resources/ for more information on vital parameter validations.

Can the Bracelet be used in water?

• The Bracelet is IP66 water resistant, which means it is protected against dust and powerful water jets only. You may take a shower with the Bracelet but it should not be used while swimming.

Can I wash the Bracelet band?

• To clean the Strap, use a lint-free cloth moistened with warm water to clean the housing and casing of your device. Use warm water and hypoallergenic soap to clean. Dry with a soft cloth.

Can Corsano help Organization and / or Researchers use the solution as an investigational device in a compliant manner?

• Informed consent language
• Protocol design
• Endpoint design
• Endpoint validation
• Regulatory discussions

It should be noted that Informed Consent, Protocol, Endpoints and Regulatory matters are the responsibility of Researchers and their Organizations. However, Corsano may assist by providing various sample documents from its own Clinical Trials.

How long does it take to start a study that would like to use the Corsano CardioWatch Program?

• Researchers may create and configure a new study on the Corsano Research Portal in a matter of minutes. Typically, preparing all required documents like Data Processing and Transfer Agreements will take 1-2 months.

Can Corsano store my data and for how long?

• Data on the Corsano Cloud will be archived in S3 AWS and deleted only upon request.

Who has access to my data?

• Only Principal Investigators who created a study on the Research Portal have access to their study data.

Can Corsano delete my data or a patient’s data?

• Upon request, Corsano will delete data as mandatory under GDPR and stipulated in the Data Processing Agreement.

Why is having CE-MDR approval important for wearables (and the resultant data) in clinical research?

• CE-MDR is a measure for validated accuracy and stringent product safety testing. The clinical trials used for collecting data for, and resultant data algorithms developed were critical for the validation and subsequent approvals that the Corsano CardioWatch Solution has obtained. Additional details on trials and the methodology used can be found at https://corsano.com/resources/publications/ for more information on vital parameter validations.