Corsano 287-2 Cardio Watch Instruction Manual

IMPORTANT

This Instruction Manual is subject to periodic review, update and revision.
This Instruction Manual provides the information necessary to operate the CardioWatch 287-2 System. PLEASE READ THIS INSTRUCTION MANUAL BEFORE OPERATING THE
SYSTEM. If any part of this Instruction Manual is not clear, contact Corsano Health for assistance. PLEASE RETAIN THIS USER MANUAL FOR FUTURE REFERENCE.
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 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 the equipment or other property.
WARNING: 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.

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 Professional (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

The bracelet is intended to continuously monitor physiological vital sign data (Pulse Rate (PR), oxygen saturation (SpO2), skin temperature (sTEMP) and activity levels (MOTION / STEP) from the person being monitored and securely transmit the encrypted data via the Patient User 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 287-2 System is also integrated with third-party devices for displaying and monitoring physiological signs (spot monitoring of: non-invasive blood pressure (NIBP), lung function & spirometry (SPIRO), weight (WEIGHT) as well as continuous monitoring of axillary temperature (aTEMP).

The healthcare professional 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.
There are three Instructions for Use:

1. Bracelet Instruction Manual – instructions for the Bracelet and Patient App
2. Portal Instruction Manual – instructions for the Web Portal
3. HCP Instruction Manual – instructions for the HCP for the System

These Instructions for Use assume a working knowledge of vital signs monitoring.
To support proper, safe, and accurate operation of the CardioWatch 287-2 System, read all operating instructions carefully before you use the system.
The CardioWatch 287-2 System should only be used by trained healthcare professionals

SAFETY INSTRUCTIONS

This instruction manual provides you with important information about the Corsano CardioWatch 287-2B Bracelet and App. To ensure the safe and proper use of the CardioWatch 287-2 System, READ and UNDERSTAND all of the safety and operating instructions. If you do not understand these instructions or have any questions, contact support@corsano.com before attempting to use this device.

WARNINGS

To maintain patient safety, adhere to all WARNINGS and CAUTIONS listed in these Instructions for Use.
The CardioWatch 287-2 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 287-2 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.
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 Web 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.
The device is not an apnea monitor. DO NOT rely on the respiration monitoring for detection of cessation of breathing.
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 device could temporarily interfere with blood flow, which could result in injury.
DO NOT use this bracelet if the patient has severe blood flow problems or blood disorders.
DO NOT use this bracelet with other medical electrical (ME) equipment simultaneously. This may result in incorrect operation of the bracelet and/or cause an inaccurate reading.
DO NOT use this bracelet in areas containing high frequency (HF) surgical equipment or hyperbaric chambers, 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.
MR-unsafe!
DO NOT expose the device to a magnetic resonance (MR) environment.
The device 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 device that can heat during MR scanning.
The device may generate artifacts in the MR image.
The device may not function properly due to the strong magnetic and radiofrequency fields generated by the MR scanner.

CAUTIONS

Patients at risk for respiratory crises should be observed closely.
Movement, ambient light, and low perfusion may affect SpO2 and pulse rate calculation and accuracy. Corsano Health B.V. is not intended for use in calculating accurate SpO2 during periods of high motion, high ambient light, and low perfusion conditions.

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.
Ambient, environmental temperature changes may impact the temperature of the patient and thus temperature monitoring.
When reviewing information from the device, make sure that no mobile device or any other electrical device that emits electromagnetic fields is within 12 inches (30 cm) of the bracelet. This may result in incorrect operation of the bracelet and/or cause an inaccurate reading.
Read all cleaning instructions carefully before cleaning the equipment. Refer to the cleaning section.
Ensure that this bracelet has acclimated to room temperature 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.

NOTES

**** Keep this manual where it can be easily located when needed.

Indications for Use

The CardioWatch 287-2 System is intended for reusable bedside, mobile and centralized multi-parameter, physiological monitoring of adult patients in professional healthcare facilities, such as hospitals or skilled nursing facilities, or their own home. It is intended for monitoring of patients by trained healthcare professionals.
The CardioWatch 287-2 System is intended to provide visual and audible physiological multi-parameter alarms.
The CardioWatch 287-2 System is intended for monitoring of skin temperature at wrist of the patient or axillary temperature with connected thermometer device.
The CardioWatch 287-2 System is intended for continuous monitoring of the following indices in adults:

• Pulse rate
• Oxygen saturation
• Temperature
• Respiration
• Movement

The CardioWatch 287-2 System is intended for intermittent or spot-check monitoring, in adults, of:

• Non-invasive blood pressure
• Lung function & spirometry
• Weight

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.

Clinical Benefit

The CardioWatch 287-2 System provides a non-invasive, comfortable continuous and accurate monitoring of vital signs with visual and audible physiological multi-parameter alarms. Data is transmitted to the Corsano Web Portal where it is reviewed by healthcare professionals.

SYMBOLS

These instructions for use contain the following symbols (color and size may vary):

2.   CORSANO APP

The Corsano App is single application that is user configured for either a Patient or HCP

Download and install the Corsano App onto your smart device.

First time use – Sign Up

Select “Sign Up” to create a user account (2) Choose Sign-Up
Enter First Name, Last name, Email\

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”
  

Sign In

**** Once you have created a user account, you can sign-in in the APP.
Select “Sign In” (1)

Enter:

• Email
• Password Press “Sign In”
  

Press “Sign In”

Corsano App (HCP Mode)

**** The HCP Code is available on the Web Portal, please click on settings for a department to access the Configuration Panel for the Department:

To configure the Corsano App in HCP Mode, the HCP must enter the HCP Code under Settings/Profile in the Corsano App, which configures the Corsano App in the HCP App mode.
The HCP can then see the list of patients linked to the Department, monitor their vital parameters and receive the alarms (patient & technical).
The HCP Mode provides the following functionality:

1. Secure logging
2. Displaying the vital parameters (PR, SpO2, RR, Temp) of the Patients
3. Displaying the Battery Levels of the Corsano Bracelet
4. Transmitting the Patient Alarms from the Web Portal
5. Generating Technical Alarms when connection problems are detected

Corsano App (Patient Mode)

**** Please ask the patient to download and register the Corsano App on their mobile phone. (you may do for the patient).
The Patient Code is available on the Web Portal, please click on settings for a department to access the Configuration Panel for the Department:

To configure the Corsano App in Patient Mode, please ask the patient to enter (or enter for patient) the Patient Code under Settings/Profile in the Corsano App, which configures the Corsano App in the Patient App mode.

Patient App Settings (Patient Mode)

In the Corsano App on the mobile phone of the patient, the you can open the Settings Menu by clicking on the icon on the top left corner.
You can see the information about the Patient App and Device.

You can see your profile data for the patient and modify if needed.
These parameters are important for the measurement accuracy.

Patient App Screens (Patient Mode)

** By default, the Corsano App in Patient Mode does not display information.
In particular cases, the HCP may decide based on therapy, that, the Patient Mode should display trending information, for instance Patient Activity (Motion Levels & Steps) Information can be displayed to encourage the patient to be more active.
CAUTION:** All information displayed in the Patient App is not for diagnostics use.

The HCP can select:

• Pulse rate (PR)
• Oxygen saturation (Sp02)
• Temperature (sTemp / aTemp)
• Activity (MOTION / STEPS)
• Respiration Rate (RR)
• Non-Invasive Blood Pressure (NIBP)
• Spirometry (SPIRO)
• Weight (Weight)

CAUTION: the information provided to the Patient is intended to provide trending data to assist the HCP in providing patient motivation. HCP decides which information is shown to the patient based on therapy.
Such examples may include:

• Activity (Steps) to motivate patient to move sufficiently
• Tracking Temperature and take medicine on instruction of HCP in case of fever
• Non-invasive blood pressure spot-measurements data to ensure that patient:
  • has properly done spot-measurements
  • has taken medicine based on instructions of HCP
• Spirometry trending to motivate patient exercise to increase in pulmonary capacity
• Pulse rate to motivate the patient to exercise to an increased pulse rate (fat burn)

The following figure gives a summary view of the available Patient Mode Screens:

NOTE: The HCP determines which screens will be seen in the Patient App via the Configuration Panel in the Web Portal

CYBERSECURITY

Information Security Management System

Corsano Health has established an Information Security Management System (“ISMS”) in accordance with ISO/IEC 27001 (“ISO 27001”) that governs the processes required to protect company and information assets. Corsano Health utilizes the ISO 27001 Information Security (“InfoSec”) frameworks in order to identify and maintain the assets, technologies, and processes needed to protect customer information and to help ensure the confidentiality, integrity, availability, and privacy of customer data and supporting services.

To enable this, Corsano Health:

1. Aligns its InfoSec policies and procedures to the global industry standard ISO 27001
2. Achieves a robust InfoSec framework for the efficient functioning of the organization

While Corsano Health has taken significant steps to protect the CardioWatch 287-2 System from cyberattacks, the user has a crucial role in maintaining cybersecurity. The guidelines in this section must be followed.

The Corsano Bracelet communicates with the Corsano App through a secure Bluetooth

5.0 communication link with a state-of-the-art encryption layer. The Corsano App transmits the data to the Corsano Cloud. Communications between the Corsano Bracelet, App and Cloud are encrypted to an industry-standard.

The Corsano App can be installed on an iOS device running iOS version 13 or greater, or an Android device running Android version 8 (Oreo) or 9 (Pie). As Apple review every application before it is allowed on the Apple App Store, the iPhone is very resilient to cyberattacks. The Google Play store reviews applications for the Android platform.

The Corsano Web Portal is accessible via the Safari or Google Chrome web browser. All communications between the Web Portal and the Corsano Cloud are encrypted to an industry-standard, using TLS1.2+.

About password policies, password expiration and auto-logout

A combination of username and password are used to control access to the Corsano App. The App requires that the user creates a strong password (More than eight characters, containing letters, digits, capital and small letters, at least one special character). It is the responsibility of the user to apply the appropriate password policies
e.g. password complexity, renewal intervals.

Follow these general recommendations on password:

• Use a minimum password length of 8 characters
• Include lowercase and uppercase alphabetic characters, numbers and symbols
• Generate passwords randomly where feasible
• Passwords should be renewed after 90 days.

About periodical software updates and patches

The Corsano App should be updated as soon as a new version becomes available. When a new version does become available, the Apple App Store in the case of iOS or the Google Play Store in the case of Android, will automatically update the app in-place. When accessing the Corsano Web Portal via the web interface, the user will always have access to the most up to date version.

Dealing with a lost or stolen Corsano Bracelet

In case a Corsano Bracelet is lost or stolen, please notify Corsano Health with the Serial Number of the bracelet.

General Guidelines for Security

1. Any mobile device with the Corsano App installed must also have a device passcode set
2. You should never disclose your Corsano username or password. No Corsano Health staff will ever ask you for these details
3. You should never write your Corsano username or password down
4. You should never provide an unauthorized user access to the Corsano App
5. You should never leave the Corsano App logged in and unattended. Please log out when you have finished using the system
6. You should never disclose protected health information within a support message to Corsano Health. This includes details like a patient’s name or date of

WARRANTY

Corsano Health warrants that components within its products will be free from defects in workmanship and materials for a period of one year from the date of purchase.
This warranty does not cover consumable items such as, but not limited to, straps.
Corsano Health shall not be liable for any incidental, special, or consequential loss, damage, or expense directly or indirectly arising from the use of its products. Liability under this warranty and the buyer’s exclusive remedy under this warranty is limited to servicing or replacing the affected products, at Corsano Health’s option, at the factory or at an authorized distributor, for any product which shall under normal use and service appear to Corsano Health to have been defective in material or workmanship.
Recommended preventative maintenance, as prescribed in the service manual, is the responsibility of the user and is not covered by this warranty.

No agent, employee, or representative of Corsano Health has any authority to bind Corsano Health to any affirmation, representation, or warranty concerning its products, and any affirmation, representation or warranty made by any agent, employee, or representative shall not be enforceable by buyer or user.
THIS WARRANTY IS EXPRESSLY IN LIEU OF, AND CORSANO HEALTH EXPRESSLY DISCLAIMS, ANY OTHER EXPRESS OR IMPLIED WARRANTIES, INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABILITY, NON-INFRINGEMENT, OR FITNESS FOR A PARTICULAR PURPOSE, AND OF ANY OTHER OBLIGATION ON THE PART OF CORSANO HEALTH.

Damage to any product or parts through misuse, neglect, accident, or by affixing any non- standard accessory attachments, or by any customer modification voids this warranty.
Corsano Health makes no warranty whatsoever in regard to trade accessories, such being subject to the warranty of their respective manufacturers.
A condition of this warranty is that the equipment or accessories which are claimed to be defective be returned when authorized, freight prepaid to Corsano Health, Wilhelmina van Pruisenweg 35, 2595 AN The Hague, The Netherlands or its authorized representative.
Corsano Health shall not have any responsibility in the event of loss or damage in transit.
Corsano Health’s obligation or liability under this warranty does not include any transportation or other charges or liability for direct, indirect or consequential damages or delay resulting from the improper use or application of the product or the use of parts or accessories not approved by Corsano Health.
This warranty shall not extend to a) malfunction or damage caused by improper use or man-made failure; b) malfunction or damage caused by improper operation or repair by unqualified or unauthorized service people; c) malfunction or damage caused by unstable or out-of-range power input; d) damage or wear and tear of straps.

SPECIFICATIONS

Corsano App

Minimum requirements for mobile device Operating Systems:

• iO 5 or higher
• Android 8.0 or higher

CORSANO CONTACT INFORMATION

Corsano Health B.V. Wilhelmina van Pruisenweg 35 2595 AN The Hague
The Netherlands www.corsano.com

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References

• Corsano Health - Biomedical Research, Raw Data IP-Free

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