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.

Study Portal Instructions for Use Ι As of 2023-01-25 Ι Revision status: 3
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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

Study Portal Instructions for Use Ι As of 2023-01-25 Ι Revision status: 3
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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.

Study Portal Instructions for Use Ι As of 2023-01-25 Ι Revision status: 3
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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.

Study Portal Instructions for Use Ι As of 2023-01-25 Ι Revision status: 3
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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