Related Manuals for Corsano CardioWatch 287-2
Summary of Contents for Corsano CardioWatch 287-2
- Page 1 CardioWatch 287-2 Bracelet & Corsano App Instruction Manual As of 2023-03-15 Ι Revision status: 14...
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Page 2: Table Of Contents
LED Explanation ......................... 13 Cleaning ............................ 14 USING YOUR BRACELET WITH THE CORSANO APP ..............15 Download and install the Corsano App onto your smart device........... 15 First time use – Sign Up ......................15 Sign In ............................16 Pairing Your Bracelet ......................... - Page 3 LEGAL NOTICE FOR FCC AND ISED ..................38 CORSANO CONTACT INFORMATION .................. 39 As of 2023-03-15 Ι Revision status: 14...
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Page 4: Introduction
The CardioWatch 287-2 is not intended for use in high-acuity environments, such as ICU or operating rooms. The CardioWatch 287-2 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. -
Page 5: Data Transmission
DO NOT use this bracelet on infants, toddlers, children or persons who cannot express themselves. DO NOT adjust medication based on readings from this bracelet. Take medication as prescribed by your physician. ONLY a physician is qualified to diagnose and treat high or irregular heartbeats. -
Page 6: Handling And Usage
2.4 Handling and Usage Stop using this bracelet and consult with your physician if you experience skin irritation or discomfort. Consult with your physician before using this bracelet on an arm where intravascular access or therapy, or an arterio-venous (A-V) shunt, is present because of temporary interference to blood flow, which could result in injury. -
Page 7: Warnings
DO NOT disassemble or attempt to repair the charger. Fully insert the USB plug at the end of the charger into the USB outlet. When unplugging the charger from the outlet, be sure to safely pull from the USB outlet. DO NOT pull from the charger cable. When handling the charger cable: DO NOT damage it. -
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
Remove this bracelet and other components from the packaging and inspect for damage. If the bracelet or any other component is damaged, DO NOT USE and contact support@corsano.com Read the Important Safety Information in this instruction manual before using this bracelet and follow this instruction manual thoroughly for your own safety. -
Page 10: Know Your Bracelet
5 KNOW YOUR BRACELET 5.1 Back and Side of the bracelet Back and Side view of Bracelet (A) Green LED (B) Orange LED (C) Blue LED 5.2 Back and bottom of the bracelet Back view of Bracelet (D) Electrodes for ECG (E) PPG Sensor (F) Charge contacts (G) Magnets for charge cable holding... -
Page 11: Data Transmission
You should notify your Physician or Healthcare Practitioner of any changes of your health condition. The device is intended to be worn on the wrist (left or right), DO NOT use on other parts of the body. DO NOT apply the wearable device on open wounds, sores, or cuts. For specific information about your own heartbeats, CONSULT WITH YOUR PHYSICIAN. -
Page 12: Charging The Bracelet
5.4 Charging the bracelet Remove the device prior to charging. Use the charger cable with a CE marked adapter with the following characteristics: Input voltage: 100/240 V - 50hz 60hz Output voltage: DC 5V (+-5%) Maximum current: 500 mA Plug the charger into the appropriate USB outlet. Fully insert the USB plug at the end of the charger into the USB outlet. -
Page 13: Led Explanation
Worn out or defective batteries can significantly reduce battery capacity or the operating time. DO NOT use the charger if the bracelet or the charger cable is damaged. If the bracelet or the cable is damaged, unplug the charger immediately. DO NOT charge the device from a multi-outlet plugs. -
Page 14: Cleaning
Use warm water and hypoallergenic soap to clean the strap. Dry the wrist band with a soft cloth. WARNING: Do not autoclave or sterilize the wearable device or any part of the CardioWatch 287-2 monitoring system. As of 2023-03-15 Ι Revision status: 14... -
Page 15: Using Your Bracelet With The Corsano App
6 USING YOUR BRACELET WITH THE CORSANO APP 6.1 Download and install the Corsano App onto your smart device. 6.2 First time use – Sign Up Select “Sign Up” to create a user account (2) Enter First Name, Last name, Email... -
Page 16: Sign In
Enter: • Your password • Your password again • The received code Press “Create account” Create account 6.3 Sign In Once you have created a user account, you can sign-in in the APP. Select “Sign In” (1) Choose Sign-In As of 2023-03-15 Ι Revision status: 14... -
Page 17: Pairing Your Bracelet
Enter: • Email • Password Press “Sign In” Sign-In 6.4 Pairing Your Bracelet Upon first sign-in, user will be asked to pair a bracelet, follow the instructions: First, select your bracelet in the list: 287-2B Pair Bracelet As of 2023-03-15 Ι Revision status: 14... - Page 18 Wait for the app to find the bracelet Connect the charger and press Start Pairing Remove charging cable to complete pairing As of 2023-03-15 Ι Revision status: 14...
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Page 19: Troubleshooting The Bluetooth Connection
6.5 Troubleshooting the Bluetooth Connection If the connection between the bracelet and app is lost, a red “X” will appear: Please follow instructions: 1. Make sure your phone is nearby 2. Check if watch is charged 3. Check if GPS is on (for Android) 4. -
Page 20: Troubleshooting The Cloud Connection
6.6 Troubleshooting the Cloud Connection If the connection between the app and the cloud is lost, a red “X” will appear: Please follow instructions: 1. Make sure your phone is connected to internet 2. Force quit the app on your phone 3. -
Page 21: Corsano App Settings (Patient Mode)
6.7 Corsano App Settings (Patient Mode) In the App, you can open the Settings Menu You can see your profile data and modify if by clicking on the icon on the top left corner. needed. You can see the information about the app These parameters are important for the and device. -
Page 22: App Screens
7 APP SCREENS 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 Levels (Motion & Steps) Information can be displayed to encourage the patient to be more active. - Page 23 The following figure gives a summary view of the available Patient Mode Screens: Pulse rate SpO2 Temperature Activity Respiration rate NIBP Weight NOTE: The HCP determines which screens will be seen in the Patient App via the Configuration Panel in the Web Portal. As of 2023-03-15 Ι...
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Page 24: Perform An Ecg
8 PERFORM AN ECG To record an ECG, launch the measurement from the APP: 1. Press “Start” Touch the metal frame with your opposite hand, according to the picture. 2. Sit down, stay still, don’t move or talk, try to relax. -
Page 25: Health App And Google Fit Integration
9 HEALTH APP AND GOOGLE FIT INTEGRATION The CORSANO app is integrated with the Apple Health and Google Fit apps. Information about your activities and vitals helps us provide you with a monthly (premium) personal report. You have the option of turning off the integration within the Apple Health and Google Fit apps;... -
Page 26: Clinical Performance
10 CLINICAL PERFORMANCE Clinical Definition Unit Range Acquisition Update Accuracy * Function time time Pulse Rate Number of beats of beats/minute 25-250 5-10 s 1.95 bpm the heart per minute (bpm) Arms RR Interval Elapsed time msec 300-2000 5-10 s RR Interval between two ±50 ms MAD,... - Page 27 1. Place the CardioWatch 287-2B device on the simulator device 2. Select the simulation heart rate (70 bpm for example) 3. Read the value in the Corsano Trials APP, on the heart rate graph, “LAST BPM”. (The error shall be less than ±1 bpm)
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Page 28: Cybersecurity
Bracelet, App and Cloud are encrypted to an industry-standard. The Corsano App can be installed on an iOS device running iOS version 14.5 or greater, or an Android device running Android version 8 (Oreo) or greater. As Apple review every application before it is allowed on the Apple App Store, the iPhone is very resilient to cyberattacks. -
Page 29: About Periodical Software Updates And Patches
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 HCP user will always have access to the most up to date version. The Corsano Bracelet firmware may require updates, if this is so you will be notified of its update as an integrated part of an update to the Corsano App. -
Page 30: Warranty
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... -
Page 31: Specification
13 SPECIFICATION Minimum requirements for mobile device Operating Systems: • iO 12.2 or higher • Android 8.0 or higher PPG Sensor Characteristics* PPG ....................Red, IR, Green PPG LED/Photodiode number ........................PPG LEDs Peak wavelength 500-900 nm ..............128 mA PPG LEDs max current .............. - Page 32 Display LEDs green, orange, blue *NOTES: PPG sensor are exposed on the back of the Corsano bracelet. The PPG sensor makes contact with the user’s skin. IP66: Totally protected against dust. Protected against strong jets of water. Information about wavelength range can be especially useful to clinicians.
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Page 33: Electrical Safety And Electromagnetic Compatibility
Portable RF communications equipment (including antenna cables, external antennas, wireless home network devices, mobile phones, and cordless phones) should be used no closer than 30cm (12 inches) to any part of the Corsano Bracelet, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. - Page 34 TYPE BF APPLIED PART 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...
- Page 35 Guidance and manufacturer’s declaration—electromagnetic immunity 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. Immunity test IEC 60601 test...
- Page 36 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 37: Disposal Of The Device
15 DISPOSAL OF THE DEVICE Once your bracelet 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 your device to a recycling service for Waste Electrical and Electronic Equipment. - Page 38 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 39 17 CORSANO CONTACT INFORMATION Corsano Health B.V. Wilhelmina van Pruisenweg 35 2595 AN The Hague The Netherlands www.corsano.com As of 2023-03-15 Ι Revision status: 14...
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