Corsano CardioWatch 287-2B Bedienungsanleitung

Bracelet Instruction Manual Ι As of 2023-08-17 Ι Revision status: 15

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

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.

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

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 
 

 
TABLE OF CONTENTS 
1TABLE OF CONTENTS .............................................................................................................. 4 
2INTRODUCTION ...................................................................................................................... 6 
3SAFETY INSTRUCTIONS ........................................................................................................... 8 
1 Warnings.....................................................................................................................................8 
2 Cautions......................................................................................................................................9 
3 Notes ........................................................................................................................................10 
4 Indications for Use.....................................................................................................................10 
5 Clinical Benefit...........................................................................................................................10 
6 Essential Performance ...............................................................................................................10 
4SYMBOLS.............................................................................................................................. 11 
5CONTENTS / PRODUCT INCLUDES ......................................................................................... 13 
1 Receiving and Inspection ...........................................................................................................13 
2 Contents....................................................................................................................................13 
6KNOW YOUR BRACELET ........................................................................................................ 14 
1 Back and Side of the bracelet.....................................................................................................14 
2 Back and bottom of the bracelet ................................................................................................14 
3 WARNINGS / CAUTIONS / RECOMMENDATIONS.........................................................................15 
4 Data Transmission .....................................................................................................................15 
5 Charging the bracelet.................................................................................................................16 
5.1 WARNINGS:.................................................................................................................................. 16 
5.2 CAUTIONS:.................................................................................................................................... 16 
6 LED Explanation.........................................................................................................................17 
7 Cleaning & Disinfection..............................................................................................................18 
7USING YOUR BRACELET WITH THE CORSANO APP................................................................. 19 
1 Download and install the Corsano App onto your smart phone...................................................19 
2 First time use –Sign Up..............................................................................................................19 
3 Sign In .......................................................................................................................................20 
4 Pairing Your Bracelet .................................................................................................................21 
5 Wearing Optimization................................................................................................................23 
5.1 Bracelet Direction ........................................................................................................................ 24 
5.2 Tightening Check.......................................................................................................................... 24 
6 Optional Wearing Optimization..................................................................................................25 
7 Corsano App Settings (Patient Mode).........................................................................................26 
8 Troubleshooting the Bluetooth Connection ................................................................................27 
9 Troubleshooting the Cloud Connection.......................................................................................28 
8EXTERNAL DEVICES............................................................................................................... 29 
1 Axillary Temperature Sensor......................................................................................................29 
2 Cuff blood pressure ...................................................................................................................30 
3 Spirometer ................................................................................................................................30 
4 Weight scale..............................................................................................................................32 
9APP SCREENS........................................................................................................................ 33 
PERFORM AN ECG ............................................................................................................. 35 
1 ECG measurement .....................................................................................................................35 
2 ECG Troubleshooting .................................................................................................................37 
3 ECG Results ...............................................................................................................................39 
4 ECG Warning .............................................................................................................................41 
5 ECG Cautions.............................................................................................................................42 

 
 
 
 Bracelet Instruction Manual Ι As of 2023-08-17 Ι Revision status: 15 
 

 
NON-INVASIVE BLOOD PRESSURE MEASUREMENT ............................................................ 43 
1 Pair the Blood Pressure Cuff to the Corsano APP ........................................................................43 
2 Perform a calibration measurement with the Blood Pressure Cuff...............................................44 
PRINCIPLE OF OPERATION................................................................................................. 47 
1 Pulse Rate principle of operation ...............................................................................................47 
2 SpO2 principle of operation .......................................................................................................48 
3 Respiration Rate principle of operation ......................................................................................49 
4 Steps Activity principle of operation...........................................................................................49 
5 Temperature principle of operation ...........................................................................................50 
6 Cuffless Non-Invasive Blood Pressure.........................................................................................50 
7 ECG ...........................................................................................................................................52 
CLINICAL PERFORMANCE................................................................................................... 53 
1 Pulse Rate .................................................................................................................................53 
2 Pulse Oximetry (SpO2)...............................................................................................................53 
3 Temperature .............................................................................................................................54 
4 Activity (Steps) ..........................................................................................................................55 
5 Respiration................................................................................................................................55 
CYBERSECURITY ................................................................................................................ 56 
1 Information Security Management System.................................................................................56 
2 About password policies, password expiration and auto-logout..................................................56 
3 About periodical software updates and patches .........................................................................57 
4 Dealing with a lost or stolen Corsano Bracelet............................................................................57 
5 General Guidelines for Security..................................................................................................57 
WARRANTY....................................................................................................................... 58 
TECHNICAL SPECIFICATIONS .............................................................................................. 59 
1 Corsano Mobile App ..................................................................................................................59 
2 Corsano Bracelet .......................................................................................................................59 
3 AC-DC Power Supply (USB Adapter)............................................................................................60 
4 Regulatory Conformity...............................................................................................................60 
5 Applied Standards .....................................................................................................................60 
ELECTRICAL SAFETY AND ELECTROMAGNETIC COMPATIBILITY........................................... 61 
LEGAL NOTICE FOR FCC AND ISED...................................................................................... 65 
DISPOSAL / END OF LIFE .................................................................................................... 66 
CORSANO CONTACT INFORMATION .................................................................................. 66 
 
 

Bracelet Instruction Manual Ι As of 2023-08-17 Ι Revision status: 15

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

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

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 support@corsano.com 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

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

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.

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