Corsano CardioWatch 287 Instruction Manual
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Summary of Contents for Corsano CardioWatch 287
- Page 1 CardioWatch 287 System Study Portal Instruction Manual Corsano Health B.V. 1912 Wilhelmina van Pruisenweg 35 2595 AN The Hague The Netherlands www.corsano.com info@corsano.com Study Portal Instructions for Use Ι As of 2023-01-25 Ι Revision status: 3...
- Page 2 All rights are reserved. Corsano Health B.V. reserves the right to alter the products described in this manual at any time without notice. No part of this manual may be reproduced, copied, translated, or transmitted in any form or by any means without the prior written permission of Corsano Health B.V.
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Page 3: Table Of Contents
About password policies, password expiration and auto-logout ............35 10.3. About periodical software updates and patches ................36 10.4. Dealing with a lost or stolen Corsano Bracelet ................36 10.5. General Guidelines for Security ....................... 36 WARRANTY ............................. 37 CORSANO CONTACT INFORMATION ....................... 38... -
Page 4: Introduction
INTRODUCTION The Corsano CardioWatch 287 System is a vital signs monitoring system that consists of a monitoring bracelet device worn on the wrist by adults (aged 18 years old and over), a user mobile application, a secure cloud and a web-based browser platform. -
Page 5: Safety Instructions
This instruction manual provides you with important information about the Corsano Study Portal. To ensure the safe and proper use of the CardioWatch 287 System, READ and UNDERSTAND all of the safety and operating instructions. If you do not understand these instructions or have any questions, contact support@corsano.com before attempting to... -
Page 6: Cautions
Patients at risk for respiratory crises should be observed closely. Movement, ambient light, and low perfusion may affect SpO2 and pulse rate calculation and accuracy. Corsano Health B.V. is not intended for use in calculating accurate SpO2 during periods of high motion, high ambient light, and low perfusion conditions. -
Page 7: Indications For Use
The CardioWatch 287 System can include the ability to notify healthcare professionals when physiological data fall outside selected parameters. The CardioWatch 287 System is intended for use on general care patients who are 18 years of age or older as a general patient monitor, to provide physiological information. -
Page 8: Symbols
SYMBOLS These instructions for use contain the following symbols (color and size may vary): Symbol Meaning This product is a medical device classified as risk category IIa, in accordance with rule 10 of EU Directive 93/42/EEC, last amended by 1912 2007/47/EC of the European Parliament and Council of 5 September 2007. -
Page 9: Study Portal
STUDY PORTAL The Corsano Study Portal enables the PI to manage the data monitoring of their subjects. Via a Web Browser, the PI configures the data to be monitored and visualize the list of subjects and vital parameters (Pulse rate, SpO2, temperature, respiration rate, movement) obtained from data originating from the Corsano Bracelet. -
Page 10: Sign-In
(Corsano will not have it). Create account 5.2. Sign-In After registration via the Corsano App, you can sign-in with your email address and password to the Corsano Study Portal at http://study.corsano.com. Sign-in Study Portal Study Portal Instructions for Use Ι As of 2023-01-25 Ι Revision status: 3... -
Page 11: Studies Dashboard
5.3. Studies Dashboard The Studies Dashboard is the homepage of the Corsano Study Portal. You can select the relevant study. Studies Dashboard 5.4. Add Study If no department has been setup on the Department Dashboard, or you want to add a new department, please click on the [ADD STUDY] button top right. -
Page 12: Assign Subjects
5.6. Assign Subjects See the Study Code on right side, i.e. in the above example. To include subjects in a study, please ask the subject to add the Study Code in their Corsano App under Settings/Profile. Department Dashboard On the Profile page under Settings in the Corsano App, the Subject is requested to enter... -
Page 13: Subjects Overview
5.7. Subjects Overview Click on a study to see an overview of subjects that are assigned to the study. Subjects Overview The screen gives the PI a general overview of the study subjects and their status. Last Update – displays how long-ago subject data was received on the portal. If last data was received more that 5 min ago, number of minutes will be displayed in red. - Page 14 If connection is lost you will see: Connection Troubleshooting Batteries – displays the remaining battery for Corsano Bracelets. Low battery levels (under 20% left) will have a yellow battery icon. Under 10% the battery icon will turn red and under 5% it will start blinking.
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Page 15: Vouchers
Vital Parameters The Subjects Overview shows five vital parameters for each subject. The parameters presented are: Pulse Rate (PR, bpm) • Blood oxygen saturation (SPO2, %) • Respiratory Rate (RR, brpm) • Motion (Steps for day) • Temperature (°C/°F) • Subject Lookup –... -
Page 16: Un-Assign Subject
Once a subject is removed, their history and measurements will no longer be NOTE: available on the Subjects Overview. All data will still be saved in the Corsano Cloud. 5.10. Subject Portfolio A click on a subject on the Subjects Overview opens the detail page for that subject. The Subject Portfolio presents the subject’s information and allows access to the subject... - Page 17 Compliance – displays percentage of day for which data was received for the subject. Edit Profile – the Personal Information is where subjects’ demographics are listed. To edit a subject’s personal information, click the [EDIT PROFILE] button on the top right of the section in the Subject Portfolio and edit Name, Gender, Year of Birth, Weight, Height.
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Page 18: Study Settings
Click Settings 6.1. Selection Bracelet The Study Portal can be used to configure studies for CardioWatch 287-1 and CardioWatch 287-2. Please select 287-1 or 287-2 from the dropdown menu on top of the Settings Page: Select CardioWatch Bracelet 287-1 or 287-2... -
Page 19: Raw Data
Please consider lowest frequency for your study. CAUTION: Increasing the recording frequency for vital parameters will reduce battery life of the CardioWatch 287 Bracelet. Lower battery life may reduce compliance. Please consider lowest frequency for your study. 6.3. Raw Data Contrary to other wearable devices, Corsano CardioWatch 287 enables Principal Investigators to record and export Raw Data. -
Page 20: Battery Life
Please consider which Raw Data should be recorded for your study. CAUTION: Recording of Raw Data will reduce battery life of the CardioWatch 287 Bracelet. Lower battery life may reduce compliance. Please consider minimal recording of Raw Data for your study. - Page 21 App on subjects’ mobile device. By default, the dashboard is set to RPM. Corsano App Dashboard Setting Corsano App Tabs: The PI decides what information is to be displayed in the Corsano App on subjects’ mobile device. Maximum 4 tabs can be selected: Subject App Tab Settings By default, no information is displayed on the Corsano App.
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Page 22: Export Data
EXPORT DATA Via the Study Portal a PI can export data for a study or individual subjects. 7.1. For a Study Data can be exported for multiple days for all subjects from the Study Dashboard: Export data for multiple subjects Please select which vital parameters should be exported: Select Period and Vital Parameters to be exported Study Portal Instructions for Use Ι... - Page 23 The system will start preparing the archive after the [EXPORT] Button is pressed: Archiving Export Request Upon completion you can download the archive and save on your computer: Archive is ready for download Depending on the size of the dataset, the waiting time can vary from seconds to minutes. CAUTION: For studies with many subjects, selection of a longer period may create too large data files.
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Page 24: For Individual Subjects
For Individual Subjects 7.2. Data can also be exported for an individual subject via the Subject Portfolio page: Data Export for Individual Subject To download ECG records data please click on button “export .csv” in the list of ECG records on the Pulse Rate tab. -
Page 25: Data
DATA CardioWatch 287 devices measure summaries for vital parameters and raw data. 8.1. Summaries Summaries contain daily summary of the vital parameter and list to individual data slots. Summary Description Comment Heart Rate Daily average summary Daily max HR Daily resting HR... - Page 26 Respiration Average summary Start time Stop time List of slots Respiration Timestamp slots Date Respiration rate Quality index (4=highest quality, 0=bad quality) Sleep Duration in minutes summary Percentage of sleep goal 1/day Sleep need duration in minutes Awake time in minutes Time in REM stage (in minutes) Time in light sleep (in minutes) Times in deep sleep (in minutes)
- Page 27 Saturation Average Only CW287-2B summary Start time Stop time List of slots Saturation Timestamp Only CW287-2B slots Date Quality index (4=highest quality, 0=bad quality) Stress Timestamp Only CW287-2B summary Average level of skin conductance in 100pS units Start time Stop time Stress slot Timestamp Only CW287-2B...
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Page 28: Raw Data
Only CW287-2: 32Hz Skin conductance in 100pS units Please see this link for examples of datasets recorded with CardioWatch 287-2. Examples of Data Files recorded with CardioWatch 287-2 Study Portal Instructions for Use Ι As of 2023-01-25 Ι Revision status: 3... -
Page 29: Data Processing Tools
8.3. Data Processing Tools Please contact Corsano for Phyton scripts to plot Filtered PPG Curves, Correlation and Bland-Altman plots. Here is an example of Filtered PPG Red and PPG iR to determine SpO2: Example Filtered PPG Red and PPG iR... -
Page 30: Api
Corsano offers a REST API to access data recorded on its secure cloud. Use of the REST API assumes a working knowledge of APIs and their implementation. 9.1. Corsano Cloud System The CardioWatch 287 Cloud has been implemented on AWS. User Data and Health Data are encrypted and fully separated. - Page 31 Create User Cloud Token CAUTION: Token must be regularly refreshed. Please make sure to REFRESH the Token every 30 minutes with this request. Refresh User Cloud Token Study Portal Instructions for Use Ι As of 2023-01-25 Ι Revision status: 3...
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Page 32: Health Cloud
CAUTION: Please do not forget to REFRESH also this Health Cloud Token Once you obtained a Health Cloud access token you can retrieve the data. Example of retrieving data of activity data of the patient: curl --request GET \ --url 'https://api.health.cloud.corsano.com/v2/raw-metrics/activity?from_date=2023-01- 10T00%3A00%3A00.000%2B00%3A00&to_date=2023-01- 10T23%3A59%3A00.000%2B00%3A00' \ --header 'Authorization: Bearer eyJ0eXAiOiJKV1QiLCJhbGciOiJIUzI1NiJ9.eyJpc3MiOiJodHRwOlwvXC9hcGkuaGVhbHR... - Page 33 Example of getting activity data of the patient using REST API Study Portal Instructions for Use Ι As of 2023-01-25 Ι Revision status: 3...
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Page 34: Developer Knowledge Base
9.4. Developer Knowledge Base Please see https://developer.corsano.com for extensive information on Corsano’s API and SDK functionality. Corsano Developer Portal The Developer Portal has 5 sections: • REST API • iOS SDK • Android SDK • BLE API • Gateway Study Portal Instructions for Use Ι As of 2023-01-25 Ι Revision status: 3... -
Page 35: Cybersecurity
Bracelet, App and Cloud are encrypted to an industry-standard. The Corsano App can be installed on an iOS device running iOS version 13 or greater, or an Android device running Android version 8 (Oreo) or 9 (Pie). As Apple review every application before it is allowed on the Apple App Store, the iPhone is very resilient to cyberattacks. -
Page 36: About Periodical Software Updates And Patches
10.4. Dealing with a lost or stolen Corsano Bracelet In case a Corsano Bracelet is lost or stolen, please notify Corsano Health with the Serial Number of the bracelet. 10.5. General Guidelines for Security 1. -
Page 37: Warranty
Pruisenweg 35, 2595 AN The Hague, The Netherlands or its authorized representative. Corsano Health shall not have any responsibility in the event of loss or damage in transit. Corsano Health’s obligation or liability under this warranty does not include any... -
Page 38: Corsano Contact Information
CORSANO CONTACT INFORMATION Corsano Health B.V. Wilhelmina van Pruisenweg 35 2595 AN The Hague The Netherlands www.corsano.com support@corsano.com Study Portal Instructions for Use Ι As of 2023-01-25 Ι Revision status: 3...
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