Corsano CardioWatch 287-2B User manual

Bracelet Instruction Manual Ι As of 2023-08-17 Ι Revision status: 15
1
EN
CardioWatch 287-2B
Bracelet & Mobile Patient App
Instruction Manual
Corsano Health B.V.
Wilhelmina van Pruisenweg 35
2595 AN The Hague
The Netherlands
1912
www.corsano.com
[email protected]

Bracelet Instruction Manual Ι As of 2023-08-17 Ι Revision status: 15
2
IMPORTANT
This Instruction Manual is subject to periodic review, update and revision, please consult the
Corsano Website for the latest version.
The following Instruction Manuals are available with CardioWatch 287-2B System:
- Bracelet & Patient Mobile Application: for the Patient & Healthcare Practitioner
- HCP Mobile App Instruction Manual: for the Healthcare Practitioner only
- Web Portal Instruction Manual: for the Healthcare Practitioner only
PLEASE READ THE RELEVANT INSTRUCTION MANUALS BEFORE OPERATING THE
SYSTEM. If any part of an Instruction Manual is not clear, contact Corsano Health for assistance.
This Instruction Manual is provided electronically, if you wish to obtain a paper copy please
contact Corsano Health.
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 Meaning
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
HCP Healthcare Practitioner
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 patient, or in damage to

Bracelet Instruction Manual Ι As of 2023-08-17 Ι Revision status: 15
3
the equipment or other property.
RECOMMENDATION : A RECOMMENDATION statement provides a proposition or
suggestion to user.
CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a
physician or other practitioner licensed by U.S. state law to use or order the use of this
device.

Bracelet Instruction Manual Ι As of 2023-08-17 Ι Revision status: 15
4
1 TABLE OF CONTENTS
1TABLE OF CONTENTS .............................................................................................................. 4
2INTRODUCTION ...................................................................................................................... 6
3SAFETY INSTRUCTIONS ........................................................................................................... 8
3.1 Warnings.....................................................................................................................................8
3.2 Cautions......................................................................................................................................9
3.3 Notes ........................................................................................................................................10
3.4 Indications for Use.....................................................................................................................10
3.5 Clinical Benefit...........................................................................................................................10
3.6 Essential Performance ...............................................................................................................10
4SYMBOLS.............................................................................................................................. 11
5CONTENTS / PRODUCT INCLUDES ......................................................................................... 13
5.1 Receiving and Inspection ...........................................................................................................13
5.2 Contents....................................................................................................................................13
6KNOW YOUR BRACELET ........................................................................................................ 14
6.1 Back and Side of the bracelet.....................................................................................................14
6.2 Back and bottom of the bracelet ................................................................................................14
6.3 WARNINGS / CAUTIONS / RECOMMENDATIONS.........................................................................15
6.4 Data Transmission .....................................................................................................................15
6.5 Charging the bracelet.................................................................................................................16
6.5.1 WARNINGS:.................................................................................................................................. 16
6.5.2 CAUTIONS:.................................................................................................................................... 16
6.6 LED Explanation.........................................................................................................................17
6.7 Cleaning & Disinfection..............................................................................................................18
7USING YOUR BRACELET WITH THE CORSANO APP................................................................. 19
7.1 Download and install the Corsano App onto your smart phone...................................................19
7.2 First time use –Sign Up..............................................................................................................19
7.3 Sign In .......................................................................................................................................20
7.4 Pairing Your Bracelet .................................................................................................................21
7.5 Wearing Optimization................................................................................................................23
7.5.1 Bracelet Direction ........................................................................................................................ 24
7.5.2 Tightening Check.......................................................................................................................... 24
7.6 Optional Wearing Optimization..................................................................................................25
7.7 Corsano App Settings (Patient Mode).........................................................................................26
7.8 Troubleshooting the Bluetooth Connection ................................................................................27
7.9 Troubleshooting the Cloud Connection.......................................................................................28
8EXTERNAL DEVICES............................................................................................................... 29
8.1 Axillary Temperature Sensor......................................................................................................29
8.2 Cuff blood pressure ...................................................................................................................30
8.3 Spirometer ................................................................................................................................30
8.4 Weight scale..............................................................................................................................32
9APP SCREENS........................................................................................................................ 33
10 PERFORM AN ECG ............................................................................................................. 35
10.1 ECG measurement .....................................................................................................................35
10.2 ECG Troubleshooting .................................................................................................................37
10.3 ECG Results ...............................................................................................................................39
10.4 ECG Warning .............................................................................................................................41
10.5 ECG Cautions.............................................................................................................................42

Bracelet Instruction Manual Ι As of 2023-08-17 Ι Revision status: 15
5
11 NON-INVASIVE BLOOD PRESSURE MEASUREMENT ............................................................ 43
11.1 Pair the Blood Pressure Cuff to the Corsano APP ........................................................................43
11.2 Perform a calibration measurement with the Blood Pressure Cuff...............................................44
12 PRINCIPLE OF OPERATION................................................................................................. 47
12.1 Pulse Rate principle of operation ...............................................................................................47
12.2 SpO2 principle of operation .......................................................................................................48
12.3 Respiration Rate principle of operation ......................................................................................49
12.4 Steps Activity principle of operation...........................................................................................49
12.5 Temperature principle of operation ...........................................................................................50
12.6 Cuffless Non-Invasive Blood Pressure.........................................................................................50
12.7 ECG ...........................................................................................................................................52
13 CLINICAL PERFORMANCE................................................................................................... 53
13.1 Pulse Rate .................................................................................................................................53
13.2 Pulse Oximetry (SpO2)...............................................................................................................53
13.3 Temperature .............................................................................................................................54
13.4 Activity (Steps) ..........................................................................................................................55
13.5 Respiration................................................................................................................................55
14 CYBERSECURITY ................................................................................................................ 56
14.1 Information Security Management System.................................................................................56
14.2 About password policies, password expiration and auto-logout..................................................56
14.3 About periodical software updates and patches .........................................................................57
14.4 Dealing with a lost or stolen Corsano Bracelet............................................................................57
14.5 General Guidelines for Security..................................................................................................57
15 WARRANTY....................................................................................................................... 58
16 TECHNICAL SPECIFICATIONS .............................................................................................. 59
16.1 Corsano Mobile App ..................................................................................................................59
16.2 Corsano Bracelet .......................................................................................................................59
16.3 AC-DC Power Supply (USB Adapter)............................................................................................60
16.4 Regulatory Conformity...............................................................................................................60
16.5 Applied Standards .....................................................................................................................60
17 ELECTRICAL SAFETY AND ELECTROMAGNETIC COMPATIBILITY........................................... 61
18 LEGAL NOTICE FOR FCC AND ISED...................................................................................... 65
19 DISPOSAL / END OF LIFE .................................................................................................... 66
20 CORSANO CONTACT INFORMATION .................................................................................. 66

Bracelet Instruction Manual Ι As of 2023-08-17 Ι Revision status: 15
6
2 INTRODUCTION
The Corsano CardioWatch 287-2 System is a Remote-Patient Monitoring System that
consists of a monitoring bracelet device worn on the wrist by adult patients (aged 18 years
old and over), a web-based browser platform and a user mobile application operable in
either Patient Mode or Healthcare Practitioner (HCP) Mode.
Vital signs data both on mobile devices and web-based dashboard are available to the
HealthCare Provider.
The following figure shows the Corsano CardioWatch 287-2 System:
CardioWatch 287-2 System
The bracelet is intended to continuously monitor physiological vital sign data (Pulse Rate
(PR), oxygen saturation (SpO2), body temperature (TEMP), blood pressure (NIBP) and
activity levels (MOTION / STEP) from the person being monitored and securely transmit
the encrypted data via the Patient App to the secure server.
The bracelet is intended for Electrocardiography spot measurements (ECG).
The bracelet is intended for use in professional healthcare facilities, such as hospitals or
skilled nursing facilities, or the home.
The Corsano CardioWatch 287-2 System is also integrated with third-party devices for
displaying and monitoring physiological signs (spot monitoring of: non-invasive blood
pressure (CuffBP), lung function & spirometry (SPIRO), weight (WEIGHT) as well as
continuous monitoring of axillary temperature (aTEMP).

Bracelet Instruction Manual Ι As of 2023-08-17 Ι Revision status: 15
7
The Healthcare Practitioner can securely access the patient physiological signs remotely
via the mobile application HCP Mode or via a browser web-interface which are also
intended to provide visual and audible physiologic multi-parameter alarms.
This instruction manual provides you with important information about the Corsano
CardioWatch 287-2B Bracelet and App. These instructions are intended for both the
Patient and the Healthcare Practitioner.
The CardioWatch 287-2 System should only be used by and under the supervision of
trained Healthcare Practitioners.
You may check the Knowledge Base under Settings within the App with answers to
Frequently Asked Questions.
You may also contact your Healthcare Practitioner if you need assistance with using the
CardioWatch 287-2B Bracelet and App.
You may also contact Corsano for Technical Questions via [email protected].

Bracelet Instruction Manual Ι As of 2023-08-17 Ι Revision status: 15
8
3 SAFETY INSTRUCTIONS
To ensure the safe and proper use of the CardioWatch 287-2B Bracelet and App, READ
and UNDERSTAND all of the safety and operating instructions.
If you do not understand these instructions or have any questions, contact your
Healthcare Practitioner or [e-mail] before attempting to use the system.
3.1 Warnings
To maintain patient safety, adhere to all WARNINGS and CAUTIONS listed in this
Instruction Manual.
The CardioWatch 287-2 System is intended for use by qualified medical personnel only;
Please always follow instructions from your Healthcare Practitioner.
The CardioWatch 287-2 System is not intended for use in high-acuity environments,
such as an ICU or operating rooms.
The CardioWatch 287-2 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, a continuous ECG monitor should be used. The CardioWatch 287-2
System is not a substitute for an ECG monitor.
Consult with your Healthcare Practitioner before using this bracelet and app if you have
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 motion, trembling, or shivering may affect the
measurement made by this device.
NEVER diagnose or treat yourself based on the physiological parameters readings.
DO NOT adjust medication based on readings from this system. You should take
medication as prescribed by your Physician. ONLY a Physician is qualified to diagnose
and treat illness of a patient. ALWAYS consult with your Physician.
The Bracelet is intended for use on a single patient, DO NOT use the Bracelet on
anyone else during patient monitoring.
The Bracelet and any other applied device parts should be removed before patient
defibrillation.
DO NOT use this Bracelet on infants, toddlers, children, or persons who cannot
express themselves. This device has not been validated in a pediatric population.
DO NOT use this Bracelet on an injured arm or an arm used as part of other medical treatment
(e.g., on an arm with an arterio-venous shunt for dialysis). Wearing the bracelet could
temporarily interfere with blood flow, which could result in injury.
DO NOT use this Bracelet if you have severe blood flow problems or blood disorders.
DO NOT use this Bracelet if you have damaged or irritated skin.
DO NOT use this bracelet with other medical electrical (ME) equipment simultaneously
other than those authorized by Corsano. This may result in incorrect operation of the
bracelet and/or cause an inaccurate reading.

Bracelet Instruction Manual Ι As of 2023-08-17 Ι Revision status: 15
9
DO NOT use this bracelet in areas containing high-frequency (HF) surgical equipment
or hyperbaric chambers, or computerized tomographic (CT) scanners. This may result
in incorrect operation of the bracelet and/or cause an inaccurate reading.
DO NOT take recordings in the close vicinity of strong electromagnetic fields (e.g.,
electromagnetic anti-theft systems, metal detectors).
DO NOT use this bracelet in oxygen-rich environments or near flammable gas. This
equipment is neither approved nor certified for use in areas where oxygen
concentrations are greater than 25% or where combustible or explosive gas mixtures
are likely to occur.
If a serious incident occurs in relation to the device, it must be reported to the
manufacturer and the Competent authority.
This Bracelet is MR-unsafe!
DO NOT expose the Bracelet to a magnetic resonance (MR) environment.
This Bracelet may present a risk of projectile injury due to the presence of
ferromagnetic materials that can be attracted by the MR magnet core.
Thermal injury and burns may occur due to the metal components of the Bracelet that
can heat during MR scanning.
The Bracelet may generate artifacts in the MR image.
The Bracelet may not function properly due to the strong magnetic and radiofrequency
fields generated by the MR scanner.
3.2 Cautions
Please inform your Healthcare Practitioner if you are at risk for respiratory crises; you
should be observed closely.
Movement, ambient light, and low perfusion may affect SpO2 and pulse rate
calculation and accuracy. Corsano 287-2 System 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 you are experiencing shock,
hypothermia, anemia or has received certain medications that reduce the blood flow in
the arteries.
Ensure that this bracelet has acclimated to operating temperatures (+10 to +40 ºC)
before taking a measurement. Taking a measurement after an extreme temperature
change may lead to an inaccurate reading.
Motion levels are provided for information purposes only. They should not be relied
upon to inform patient care.
3rd party external devices shall not be used outside their intended use, including

Bracelet Instruction Manual Ι As of 2023-08-17 Ι Revision status: 15
10
intended patients nor operating conditions.
The Bracelet is provided non-sterile.
3.3 Notes
Keep this manual where it can be easily located when needed.
3.4 Indications for Use
The CardioWatch 287-2 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), respiration rate, activity, sleep, ECG, SpO2, Body Temperature
and Blood Pressure. 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 287-2 System is not intended for use in high-acuity environments, such
as an ICU or operating rooms.
The CardioWatch 287-2 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 287-2 System
is not a substitute for an ECG monitor.
The CardioWatch 287-2 System is not intended for SpO2 monitoring in conditions of high
motion or low perfusion.
3.5 Clinical Benefit
The CardioWatch 287-2 System provides a non-invasive, comfortable monitoring of vital
signs with visual and audible physiological multi-parameter alerts. Data is transmitted to
the Corsano Web Portal where it is reviewed by Healthcare Practitioners (HCP).
The principal clinical benefit of the CardioWatch 287-2 System is to provide patient
monitoring of non-invasive vital signs data with patient adjustable visual & audible
physiological alerts to the Healthcare Practitioner.
A secondary clinical benefit is that the Healthcare Practitioner may decide, based on the
patients therapy, that the Corsano App in Patient Mode should display patient trending
information, for instance Patient Activity (Motion Levels & Steps) to encourage the patient
to be more active or to better adhere to Healthcare Practitioner instructions.
3.6 Essential Performance
The essential performance in accordance with the IEC 60601-
1:2005+AMD1:2012+AMD2:2020 for CardioWatch 287-2 System has been established as
the ability of the system to maintain precision measurements on SpO2, PR, Body
temperature, Respiration Rate as well as data transmission.
The precision measurements have been established as per IEC collateral standards and
where appropriate product specification.