Related Manuals for Corsano CardioWatch 287-2
Summary of Contents for Corsano CardioWatch 287-2
- Page 1 CardioWatch 287-2 Bracelet Instruction Manual As of 2022-11-17 Ι Revision status: 12...
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Page 2: Table Of Contents
Charging the bracelet ......................... 11 USING YOUR BRACELET WITH A SMART DEVICE ..............13 Download and install the free “CORSANO” app onto your smart device........13 First time use ..........................13 Pairing Your Bracelet with a Smart Device .................. 18 7.3.1... -
Page 3: Introduction
The CardioWatch 287-2 System is not intended for use in high-acuity environments, such as ICU or operating rooms. The CardioWatch 287-2 System is not intended for use on acutely ill cardiac patients with As of 2022-11-17 Ι Revision status: 12... -
Page 4: Receiving And Inspection
ECG. 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. -
Page 5: Data Transmission
• This product contains small parts that may cause a choking hazard if swallowed by infants, toddlers or children. • The individual packaging contains important information, it should not be thrown away. 3.3 Data Transmission This product emits radio frequencies (RF) in the 2.4 GHz band. DO NOT use this product in locations where RF is restricted, such as on an aircraft or in hospitals. -
Page 6: Warnings
o Input voltage: 100/240 V - 50hz 60hz o Output voltage: DC 5V (+-5%) o Maximum current: 500 mA • DO NOT use the charger if this bracelet or the charger cable is damaged. If this bracelet or the cable is damaged, unplug the charger immediately. •... -
Page 7: Clinical Benefit
Clinical benefit The CardioWatch 287 provides a non-invasive and comfortable solution to continuously and accurately monitor vital signs and enables off-line analysis and screening of cardiac arrhythmia (AFib for instance) by third-party medial applications. Cleaning and service life Use a lint-free cloth moistened with warm water to clean the housing and casing of your device. -
Page 8: Symbols
4 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
5 CONTENTS / PRODUCT INCLUDES Figure 1 -Bracelet (CS-287-1B) Figure 2 - Charger (CS-287CH-1) Figure 3 - Instruction Manual (CS-287IFUEN-1) NOTE: Follow instructions for use. As of 2022-11-17 Ι Revision status: 12... -
Page 10: Know Your Bracelet
6 KNOW YOUR BRACELET 6.1 Back and side of the bracelet (A) Green LED (B) Orange LED (C) Blue LED Figure 4 – Front view of Bracelet 6.2 Back and bottom of the bracelet (D) Electrodes for ECG (E) PPG Sensor (F) Charge contacts (G) Magnets for charge cable holding Figure 5 –... -
Page 11: Charging The Bracelet
6.3 Charging the bracelet Figure 6 – Charging view Attach the charger cable to the backside of the bracelet. The magnets will pull the charger head to the bracelet. The Magnets will click the charger into position. The LED will light up to indicate that charging has started. - Page 12 Bluetooth Low Energy connection Bracelet connected to a Orange (B) ON for 5 seconds Smartphone Bracelet is performing an Blue (C) ECG measurement When the bracelet is close to the end of its battery autonomy, the user gets a notification through the mobile APP (20% remaining).
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Page 13: Using Your Bracelet With A Smart Device
7 USING YOUR BRACELET WITH A SMART DEVICE 7.1 Download and install the free “CORSANO” app onto your smart device. 7.2 First time use Select Sign Up (2) to create your account. If you have an account, select Sign In (1) - Page 14 Sign Up Enter your Email Address, First Name and Last Name. Agree to Terms of Service and Privacy Policy. Press the Sign Up button As of 2022-11-17 Ι Revision status: 12...
- Page 15 You will receive an email with a link to the confirmation page. Please fill your password and confirm password. When ready, press the Continue button. As of 2022-11-17 Ι Revision status: 12...
- Page 16 A password should have at least 8 characters, at least one letter a, b, c…, at least one number, and both Upper and Lower case characters. Password must NOT contain only numbers or consecutive characters As of 2022-11-17 Ι Revision status: 12...
- Page 17 After you have signed up, you can Sign-In: As of 2022-11-17 Ι Revision status: 12...
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Page 18: Pairing Your Bracelet With A Smart Device
7.3 Pairing Your Bracelet with a Smart Device 7.3.1 Pairing with the bracelet 287-2B Upon first sign-in, user will be asked to pair a bracelet, follow the instructions: First, select “287-2B” in the list: As of 2022-11-17 Ι Revision status: 12... - Page 19 Press the pusher, the orange LED will flash, the bracelet is waiting for pairing. Press on button in the app to start After button is pressed app will look for pairing. the bracelet As of 2022-11-17 Ι Revision status: 12...
- Page 20 Once the device is found, confirm the The app is then ready to go. pairing by pressing “Pair”. On successful pairing, the bracelet will light the orange LED up for 10 seconds and then turn it OFF. Figure 8 – APP Pairing, complete When your bracelet is connected successfully to your smart device, the green “V”...
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Page 21: Troubleshooting The Bluetooth Connection
7.4 Troubleshooting the Bluetooth Connection If the connection between the bracelet and app is lost, a red “X” will appear: Click on the button Please Reconnect and follow instructions: 1. Make sure your phone is nearby 2. Check if watch is charged 3. -
Page 22: Troubleshooting The Cloud Connection
7.5 Troubleshooting the Cloud Connection If the connection between the app and the cloud is lost, a red “X” will appear: Click on the button Please Reconnect and follow instructions: 1. Make sure your phone is connected to internet 2. Force quit the app on your phone 3. -
Page 23: Record Patients
8 RECORD PATIENTS Click on “New Patient” Click on “Start Session” During the measurement, please do not remove the app from multitasking. The screen of the phone can be locked. Please keep an internet connection on the phone while measuring. Please keep the phone close to the bracelet (few meters maximum) when measuring. - Page 24 When you want to stop the measurement, The app will stop the measurement and click on “Stop Measurement” synchronize the remainng data present in the device. Click on “Done” You can start these steps again to record other patients. Confirm the stopping of the measurement by clicking on “Yes”: As of 2022-11-17 Ι...
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Page 25: Non-Medical Information
9 NON-MEDICAL INFORMATION The CORSANO app provides non-medical information like Activity: As of 2022-11-17 Ι Revision status: 12... - Page 26 Sleep: As of 2022-11-17 Ι Revision status: 12...
- Page 27 Heart Rate: ECG: To record an ECG, launch the measurement from the APP: • Tap “New Patient” • Tap “Start 2 min. ECG measurement” • At the end of the measurement, that data is available in the cloud As of 2022-11-17 Ι Revision status: 12...
- Page 28 The CardioWatch 287-2B is not intended for infants weighing less than 10 kg. The CardioWatch 287-2B is not able to display pacemaker pulses. The Heart Rate from ECG is calculated by counting the number of R peaks in 6 seconds and multiply by 10.
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Page 29: Alarms In Portal
10 ALARMS IN PORTAL The CORSANO TRIALS app collects metrics from the device and synchronizes to the cloud. When alarm conditions are met, data are highlighted in the patient summary page, available for the physicians to check the patients. The delay in alarm generation depends on the synchronization time of the device data with the cloud. - Page 30 Caution: setting the limit values to extreme can render the alarm system useless. Alarms and audible signals are displayed according to the priority level: • High priority: red Setting the alarm limits is protected by password. Only responsible persons can adjust. As of 2022-11-17 Ι...
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Page 31: Health App And Google Fit Integration
11 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 32: Clinical Performance
12 CLINICAL PERFORMANCE Definition Unit Range Acquisition Update Accuracy * Time interval Heart Rate* Number of beats/minute 30-220 5-10 sec 1 sec HR is ±4 bpm beats of the (bpm) MAD, ±5% heart per MARD (at rest) minute RR Interval Elapsed time msec 300-2000... - Page 33 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 34: 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 35 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 36: 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 37 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 38 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 39 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 40: 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 41: 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 42: Corsano Contact Information
17 CORSANO CONTACT INFORMATION Corsano Health B.V. Wilhelmina van Pruisenweg 35 2595 AN The Hague The Netherlands www.corsano.com As of 2022-11-17 Ι Revision status: 12...
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