Corsano CardioWatch 287 User manual

Study Portal Instructions for Use Ι As of 2023-01-25 Ι Revision status: 3
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EN
CardioWatch 287 System
Study Portal Instruction Manual
Corsano Health B.V.
Wilhelmina van Pruisenweg 35
2595 AN The Hague
The Netherlands
1912
www.corsano.com
[email protected]

Study Portal Instructions for Use Ι As of 2023-01-25 Ι Revision status: 3
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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. Information provided in this manual is
intended to be accurate and reliable. However, Corsano Health B.V. assumes no
responsibility for use of this manual, for any infringements upon the rights of third parties
which may result from such use. All brand and product names mentioned herein are
trademarks or registered trademarks of their respective holders.
Copyright Notice: Corsano is a trademark of Corsano Health B.V. This document is
copyrighted by Corsano Health B.V.
List of Abbreviations
Abbreviation Abbreviation Meaning
A-V Arterio-venous
ECG Electrocardiogram
EMC Electromagnetic Compatibility
FCC Federal Communications Commission
HF High Frequency
ICU Intensive Care Unit
ISED Innovation, Science and Economic Development Canada
LED Light Emitting Diode
MRI Magnetic Resonance Image
RF Radiofrequency
RPM Respirations per Minute
RSS Radio Standards Specifications
SpO2 Functional oxygen saturation
USB Universal Serial Bus
WEEE Waste Electrical and Electronic Equipment
WARNING: A WARNING statement provides information about a potentially
hazardous situation which, if not avoided, could result in serious injury or damage.
CAUTION: A CAUTION statement provides information about a potentially hazardous
situation which, if not avoided, may result in injury to the user or subject, or in damage
to the equipment or other property.
In the United States, this product is for Investigational Use Only.

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1. TABLE OF CONTENTS
1. TABLE OF CONTENTS ..................................................................................................................................... 3
2. INTRODUCTION ............................................................................................................................................ 4
3. SAFETY INSTRUCTIONS ................................................................................................................................. 5
3.1. WARNINGS ........................................................................................................................................... 5
3.2. CAUTIONS ............................................................................................................................................. 6
3.3. NOTES ................................................................................................................................................... 6
3.4. Indications for Use ................................................................................................................................ 7
3.5. Clinical Benefit ...................................................................................................................................... 7
4. SYMBOLS ...................................................................................................................................................... 8
5. STUDY PORTAL ............................................................................................................................................. 9
5.1. Sign-Up ................................................................................................................................................. 9
5.2. Sign-In ................................................................................................................................................ 10
5.3. Studies Dashboard .............................................................................................................................. 11
5.4. Add Study ........................................................................................................................................... 11
5.5. Delete Study ....................................................................................................................................... 11
5.6. Assign Subjects ................................................................................................................................... 12
5.7. Subjects Overview .............................................................................................................................. 13
5.8. Vouchers ............................................................................................................................................. 15
5.9. Un-assign Subject ................................................................................................................................ 16
5.10. Subject Portfolio ............................................................................................................................. 16
6. STUDY SETTINGS ......................................................................................................................................... 18
6.1. Selection Bracelet ............................................................................................................................... 18
6.2. Vital Parameters ................................................................................................................................. 18
6.3. Raw Data ............................................................................................................................................ 19
6.4. Battery Life ......................................................................................................................................... 20
6.5. Corsano App Settings .......................................................................................................................... 20
7. EXPORT DATA ............................................................................................................................................. 22
7.1. For a Study .......................................................................................................................................... 22
7.2. For Individual Subjects ........................................................................................................................ 24
8. DATA .......................................................................................................................................................... 25
8.1. Summaries .......................................................................................................................................... 25
8.2. Raw Data ............................................................................................................................................ 28
8.3. Data Processing Tools ......................................................................................................................... 29
9. API .............................................................................................................................................................. 30
9.1. Corsano Cloud System ........................................................................................................................ 30
9.2. Users Cloud ......................................................................................................................................... 30
9.3. Health Cloud ....................................................................................................................................... 32
9.4. Developer Knowledge Base ................................................................................................................. 34
10. CYBERSECURITY ...................................................................................................................................... 35
10.1. Information Security Management System ..................................................................................... 35
10.2. 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
11. WARRANTY ............................................................................................................................................. 37
12. CORSANO CONTACT INFORMATION ....................................................................................................... 38

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2. 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.
Vital signs data both on mobile devices and web-based dashboard are available to the
researcher and subject based on Study Settings.
The following figure shows the Corsano CardioWatch 287 System for studies:
CardioWatch 287 System
The bracelet is intended to continuously monitor physiological vital sign data from the
person being monitored and securely transmit the encrypted data via the Corsano App to
the secure server.
The bracelet is intended for use in professional healthcare facilities, such as hospitals or
skilled nursing facilities, or the home by trained healthcare professionals.
The Corsano CardioWatch 287 System is also integrated with third-party devices for
displaying and monitoring physiological signs (spot monitoring of: non-invasive blood
pressure, lung function & spirometry, weight as well as continuous monitoring of axillary
temperature.
This Instructions for Use Manual is for the Study Portal only. Please contact Corsano for
instructions for the Web Portal for typical Remote Patient Monitoring (RPM) and In-
Hospital monitoring.
These Instructions for Use assume a working knowledge of vital signs monitoring.
To support proper, safe, and accurate operation of the CardioWatch 287 System, read all
operating instructions carefully before you use the system.

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3. 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 [email protected] before attempting to
use this device.
3.1. WARNINGS
To maintain subject safety, adhere to all WARNINGS and CAUTIONS listed in these
Instructions for Use.
The CardioWatch 287 System is intended for use by qualified medical personnel only;
USA Federal Law restricts this device to sale by or on prescription of a Physician.
The CardioWatch 287 System is not intended for use in high-acuity environments,
such as an ICU or operating rooms.
The CardioWatch 287 System is not intended for use on acutely ill cardiac patients
with the potential to develop life threatening arrhythmias, e.g., very fast atrial
fibrillation. For these patients, continuous ECG monitor should be used. The
CardioWatch 287 System is not a substitute for an ECG monitor.
The CardioWatch 287 System is not intended for SpO2 monitoring in conditions of
high motion or low perfusion.
Consult with the Physician before using this system for a patient that has common
arrhythmias such as atrial or ventricular premature beats or atrial fibrillation; arterial
sclerosis; poor perfusion; diabetes; pregnancy; pre-eclampsia or renal disease. Any of
these conditions in addition to patient motion, trembling, or shivering may affect the
measurement made by this device.
The physiological parameters and alarms displayed on the Study Portal are for
Healthcare Practitioners reference only and cannot be directly used as the basis for
clinical treatment. NEVER diagnose or treat the patient solely based on the patient’s
readings.
DO NOT adjust medication based on readings from this system. The patient should
take medication as prescribed by the patient’s Physician. ONLY a Physician is
qualified to diagnose and treat illness of the patient. ALWAYS consult with the
patient’s Physician.
If any value displayed on the Study Portal is abnormal or questionable, first determine
the patient’s vital signs by alternative means and then verify that Study Portal is
working correctly.
The device is not an apnea monitor. DO NOT rely on the respiration monitoring for
detection of cessation of breathing.

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3.2. CAUTIONS
The computer running the Study Portal software must utilize an emergency power
system. Failure to do so will result in loss of monitoring during extended periods of
power failure. Hospitals without an emergency power system should use an
Uninterruptible Power Supply (UPS) to power the computer running the Study Portal
software. When there is a power failure, the system should be shut down by following
the specified shutdown procedure before the UPS is turned off. If the system has a
sudden power failure, system failure may occur and consequently the system will not
work correctly next time.
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.
SpO2 measurements are particularly sensitive to the pulsations in the artery and the
arteriole. Measurements may not be accurate if the patient is experiencing shock,
hypothermia, anemia or has received certain medications that reduce the blood flow in
the arteries.
3.3. NOTES
Keep this manual in the vicinity of the computer running the Study Portal software so
that it can be easily located when needed.
During normal use, the operator is expected to face the front of the equipment.

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3.4. Indications for Use
The CardioWatch 287 System is a wireless remote monitoring intended for continuous
collection of physiological data in home and healthcare settings. This includes heart rate,
heart rate variability (R-R interval), SpO2, temperature, respiration rate, activity and sleep.
Data is transmitted wirelessly from the device via the application or gateway to a server or
health cloud where it is stored and made available for further analysis.
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.
The data from the CardioWatch 287 System is intended to be integrated in medical
devices as an aid to diagnosis and treatment. It is not intended for use on critical care
patients nor replace standard monitoring and/or routine care.
The CardioWatch 287 System is not intended for use on acutely ill cardiac patients with
the potential to develop life threatening arrhythmias e.g. very fast atrial fibrillation. For
these patients, they should be monitored using a device with continuous ECG. The
CardioWatch 287 System is not a substitute for an ECG monitor.
The CardioWatch 287 System is not intended for SpO2 monitoring in conditions of high
motion or low perfusion.
3.5. Clinical Benefit
The CardioWatch 287 System provides a non-invasive, comfortable continuous and
accurate monitoring of vital signs. Data is synched to the Corsano Study Portal where it is
reviewed by healthcare professionals.

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4. SYMBOLS
These instructions for use contain the following symbols (color and size may vary):
Symbol
Meaning
1912
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
2007/47/EC of the European Parliament and Council of 5 September 2007.
Indicates the medical device manufacturer
Indicates the need for the user to consult the instructions for use for
important information such as warnings and cautions. A warning is always
related to safety.
Note
Indicates the need for the user to consult the instructions for use
Applied Part
TYPE BF Applied Part (IEC 60417-5333)
Indicates the manufacturer's reference so the medical device can
be identified
Indicates the manufacturer's serial number so that a specific medical device
can be identified
CE marking indicates that a product complies with applicable European Union
regulations
FCC marking indicates the electronic device, which sold in the United
States, is certified and the electromagnetic interference from the device is
under the limits that are approved by Federal Communications Commission
Indicates a product should not be disposed of in a landfill; the black bar
indicates that the equipment was manufactured after 2005
Refer to instruction manual/booklet.
The wearable device does not generate alarms.

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5. 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.
Parameters measured by compatible 3rd Party medical devices (Non-invasive blood
pressure, lung function & spirometry, weight, axillary temperature) are displayed also on
the Corsano Study Portal.
5.1. Sign-Up
You will first need to sign-up via the Corsano App. Please download and install the
Corsano App onto your smart device.
Select “Sign Up” to create a user account (2)
Choose Sign-Up
Enter First Name, Last name, Email
Sign-Up

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Agree on Terms of Service and Privacy Policy
An email is sent to you with a 6-digit code.
Enter:
• Your password
• Your password again
• The received code
Press “Create account”
The password you use during registration is
encrypted and will be known to you only
(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

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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. You can type the name of
the department and a description, then click [Save].
Add Study
5.5. Delete Study
A Study can be deleted by clicking on the icon. To avoid that a study is accidentally
deleted, you will need to confirm deletion.
Delete Study

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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
the Study Code in the Code Field:
Add Study Code in Corsano App on Subjects mobile device

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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.
This could be due to several reasons, such as an issue with the device, the connection to
the App, connection between the App and the Cloud or connection between the Study
Portal and the Cloud.

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Click on the Last Update icon to see connection status. If connection is good, you will see:
Portal is connected and receiving data
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.
If battery is empty the system will display an alarm on the Dashboard:
Low battery. Charge device

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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 – on the top right of the dashboard. Enables the search of a specific
subject. Once selected, a list of all subjects in the study will appear. You can look up a
subject by name or voucher code.
5.8. Vouchers
On the top middle of the dashboard. You can create voucher codes to de-identify subjects.
Health data for each subject is saved under the voucher assigned to that subject. To add
new voucher codes in the study you need to click on button “Vouchers”.
Create Vouchers to De-Identify Patients
Then please provide number of vouchers you want to create.
Type Number of Vouchers you want to create

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Please click on the [ADD USERS] button to confirm the number of vouchers you want to
create. The system creates new patients with unique voucher codes. These voucher
codes are then used instead of emails when patients Sign-In in the Corsano App.
5.9. Un-assign Subject
This function is used to un-assign a subject from the overview, for example, when a
subject is discharged. Click on the Unlink icon and select confirm on the pop-up message.
Remove subject from Subject Overview
NOTE: Once a subject is removed, their history and measurements will no longer be
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
graphs per vital parameter.
Subject Portfolio

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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.
Edit Subject Profile

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6. STUDY SETTINGS
The Corsano CardioWatch 287 System enables the Principal Investigator (PI) to adjust
Settings for a study:
• Which vital parameters should be recorded
• At what frequency
• If Raw Data should be recorded and stored in cloud
• What information should be shown on Subject App
From the Studies Dashboard in the Study Portal, the PI can adjust 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
NOTE: CardioWatch 287-1 can record only part of vital parameters in comparison
with CardioWatch 287-2
6.2. Vital Parameters
The PI can adjust the default selection of vital parameters that should be recorded. The
following shows the default settings for CardioWatch 287-2:

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Default Vital Parameter Settings for CardioWatch 287-2
CAUTION: Increasing the recording frequency for vital parameters will increase the
size of data stored in cloud. Exporting high volume datasets will take longer and may
have to be split in multiple downloads. 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. By default, recording of Raw Data is disabled.
Selection of Raw Data Frequency

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CAUTION: Recording of Raw Data will increase the size of data stored in cloud
significantly. Exporting high volume datasets will take longer and may have to be split
in multiple downloads. 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.
6.4. Battery Life
While changing settings for vital parameters and Raw Data, the estimated autonomy of
the CardioWatch Bracelet will by dynamically updated:
Autonomy Estimation
The following table shows estimated battery life for different settings:
Estimated Battery Life in days of Autonomy
6.5. Corsano App Settings
The PI may decide that the Corsano App on subjects’ mobile device should display
trending information, for instance Subject Activity Levels (Motion & Steps) Information can
be displayed to encourage the subject to be more active.
CAUTION: the information provided to the Subject is intended to provide trending data
to assist the PI in providing subject motivation. The PI decides which information is
shown to the subject based on study protocol.