Summary of Contents for Corsano CardioWatch 287-G
- Page 1 CardioWatch 287-G Gateway Gateway Instruction Manual Corsano Health B.V. Wilhelmina van Pruisenweg 35 2595 AN The Hague The Netherlands www.corsano.com As of 2023-03-14 Ι Revision status: 3...
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Page 2: Table Of Contents
SYMBOLS ..........................8 CONTENTS / PRODUCT INCLUDES ..................... 9 SETUP THE GATEWAY ......................10 Download and install the free “CORSANO TRIALS” app onto the smart device......10 First time use – Sign Up ........................ 10 Setup the Cloud Portal ........................12 Register Gateways in the Cloud Portal .................. -
Page 3: Introduction
1 INTRODUCTION This document is a guide on how to setup and use Corsano Gateway. Corsano Gateway is a device that connects automatically to Corsano Bracelets (287-2 and 287-1), downloads all the health data that has been measured by the bracelets and then uploads this data to the cloud database. -
Page 4: Intended Use
Remove this gateway and other components from the packaging and inspect for damage. If this bracelet or any other components is damaged, DO NOT USE and contact support@corsano.com Read the Important Safety Information in this instruction manual before using this gateway. -
Page 5: Data Transmission
NOT use on other parts of the body. • Consult with the physician before using the CardioWatch 287 System if the patient has common arrhythmias such as atrial or ventricular premature beats or atrial fibrillation; arterial sclerosis; poor perfusion; diabetes; pregnancy; pre-eclampsia or renal disease. -
Page 6: Charger Handling And Usage
equipment simultaneously. This may result in incorrect operation of the bracelet and/or cause an inaccurate reading. • Ensure that the CardioWatch 287 System has acclimated to room temperature before taking a measurement. Taking a measurement after an extreme temperature change could lead to an inaccurate reading. -
Page 7: Residual Risks
The patient may be experiencing a cardiac arrhythmia or other disease even in the absence of a notification from the APP. The patient should notify the practitioner at any changes of the health condition. If a serious incident occurs in relation to the device, it must be reported to the manufacturer and the competent authority. -
Page 8: Symbols
3 SYMBOLS These instructions for use contain the following symbols (color and size may vary): Symbol Meaning This stand-alone software is a medical device classified as risk category IIa, in accordance with rule 10 of EU Directive 93/42/EEC, last amended 1912 by 2007/47/EC of the European Parliament and Council of 5 September 2007. -
Page 9: Contents / Product Includes
Figure 1 – CardioWatch 287-G Gateway One USB-C AC adapter: Figure 2 – AC adapter One package box with instructions: Figure 3 - Instruction Manual (ENG IFU Corsano CardioWatch 287-G Gateway) NOTE: Follow instructions for use. As of 2023-03-14 Ι Revision status: 3... -
Page 10: Setup The Gateway
5 SETUP THE GATEWAY 5.1 Download and install the free “CORSANO TRIALS” app onto the smart device. 5.2 First time use – Sign Up Select “Sign Up” to create a user account Enter 1. First name 2. Last name 3. Email 4. - Page 11 An email is sent to you with a 6-digit code. Enter: • The password • The password again • The received code Press “Create account” The password must follow the minimum requirements for security that are indicated in the page. The user account is created.
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Page 12: Setup The Cloud Portal
5.3 Setup the Cloud Portal Now that you have an account, you can setup the Corsano Cloud Portal. Please follow the instructions below. a. Login to the Corsano Cloud Portal with same email and password (used in the app) in this page: https://study.corsano.com/ b. -
Page 13: Register Bracelets In The Cloud Portal
On the bracelet carton box, please note the white label that indicates the serial number in front of “S/N”. The Mac Address will be send by Corsano, please contact your contact person at Corsano if not received. - Page 14 a. Click on the “Bracelets” tab on the top menu b. Click on “ADD NEW” c. Give a name to the bracelet. It is better to put the serial number as the name for future tracking. d. Choose correctly the bracelet type, 287-1 or 287-2 bracelets. e.
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Page 15: Register Patients In The Cloud Portal
5.6 Register Patients in the Cloud Portal The data of the bracelets need to be assigned to a patient in the portal. For every bracelet you will have one patient. Please follow the instructions below to create patients in the Cloud Portal. -
Page 16: Setup A Wifi Network For The Gateways
Please note that the gateway cannot connect to the networks that require logging in a web browser. If you want to use such network, you will need to add the WiFi MAC address of the gateway (provided by Corsano) to the trusted list of the servers. a. Open Corsano Trials app b. -
Page 17: Access The Data Of The Patients
g. The app will display the list of all the Gateways near you. Select the one you want to set up. h. The app will start a connection the gateway. It will ask for pairing, please accept. Once the connection is ok, write carefully the WiFi SSID name and password. Click on Save. - Page 18 As of 2023-03-14 Ι Revision status: 3...
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Page 19: Specification
6 SPECIFICATION Data Acquisition Memory Size ................. 4 GB Power Requirements Input power (5V DC via USB-C header) ........minimum 3A Input power (5V DC via GPIO header) .......... minimum 3A Input power (Power over Ethernet) ..........enabled Dimensions Length x Width x Height ............... 17cm x 10cm x 3cm Environmental Specifications Operational Temperature .............. -
Page 20: Electrical Safety And Electromagnetic Compatibility
Guidance and manufacturer's declaration - electromagnetic emissions The Corsano Bracelet is intended for use in the electromagnetic environment specified below. The customer or the user of Corsano Bracelet should assure that it is used in such an environment. Emissions test... - Page 21 Guidance and manufacturer’s declaration—electromagnetic immunity Corsano racelet is intended for use in the electromagnetic environment specified below. The customer or the user of Corsano bracelet should assure that it is used in such an environment. Electromagnetic environment - Immunity test...
- Page 22 To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which Corsano bracelet is used exceeds the applicable RF compliance level above, Corsano bracelet should be observed to verify normal operation.
- Page 23 RF communications equipment and Corsano Bracelet Corsano Bracelet is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Corsano bracelet can help prevent electromagnetic interference by...
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Page 24: Disposal Of The Device
8 DISPOSAL OF THE DEVICE Once the gateway has reached its end of life it has to be properly recycled so that the material can be reused and will not end up in the environment. Preferably bring the device to a recycling service for Waste Electrical and Electronic Equipment. -
Page 25: Legal Notice For Fcc And Ised
The device can be operated at a distance of 0-20 cm or higher. NOTICE: Changes or modifications made to this equipment not expressly approved by Corsano Health B.V. may void the FCC authorization to operate this equipment. NOTE: L’émetteur/récepteur exempt de licence contenu dans le présent appareil est conforme aux CNR d’Innovation, Sciences et Développement économique Canada... -
Page 26: Corsano Contact Information
10 CORSANO CONTACT INFORMATION Corsano Health B.V. Wilhelmina van Pruisenweg 35 2595 AN The Hague The Netherlands www.corsano.com As of 2023-03-14 Ι Revision status: 3...
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