Related Manuals for Corsano CardioWatch 287-1B
Summary of Contents for Corsano CardioWatch 287-1B
- Page 1 CardioWatch 287-1B Bracelet & Corsano Trials App Instruction Manual As of 2022-07-27 Ι Revision status: 10...
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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 Trials” app onto your smart device........ 13 First time use ..........................13 Pairing Your Bracelet with a Smart Device .................. 18 Troubleshooting the Bluetooth Connection ................ -
Page 3: Introduction
2 SAFETY INSTRUCTIONS This instruction manual provides you with important information about the Corsano CardioWatch 287-1B Bracelet. To ensure the safe and proper use of this bracelet, 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... -
Page 4: Data Transmission
prescribed by your physician. ONLY a physician is qualified to diagnose and treat high or irregular heartbeats. • DO NOT use this bracelet on an injured arm or an arm under medical treatment. • DO NOT use this bracelet in areas containing high frequency (HF) surgical equipment, magnetic resonance imaging (MRI) equipment, computerized tomography (CT) scanners. -
Page 5: 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 6: Warnings
You should contact your practitioner to get a diagnostics confirmation. 2.8 Clinical benefit The CardioWatch 287-1B 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. - Page 7 Use warm water and hypoallergenic soap to clean the strap. Dry the wrist band with a soft cloth. It is not necessary to sterilize the device. The Smartwatch is an electronic device with rechargeable battery. The expected service life is 5 years. As of 2022-07-27 Ι...
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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
4 CONTENTS / PRODUCT INCLUDES Figure 1 -Bracelet (CS-287-1B) Figure 2 - Charger (CS-287CH-1) Figure 3 - Instruction Manual (CS-287IFUEN-1) As of 2022-07-27 Ι Revision status: 10... -
Page 10: Know Your Bracelet
5 KNOW YOUR BRACELET 5.1 Front of the bracelet (A) Ambient Temperature Sensor (B) LEDs (C) Pusher button Figure 4 – Front view of Bracelet 5.2 Back and bottom of the bracelet (D) Temperature Sensors (E) PPG Sensor (F) Magnets (G) Charge Contacts Figure 5 –... -
Page 11: Charging The Bracelet
5.3 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. Figure 7 – Charging view – charger attached The Magnets will click the charger into position. The LEDS will light up to indicate that charging has started. - Page 12 Figure 8 – Charging view – charger attached #2 The polarity of the magnets in the bracelet and the charger will ensure that the charger contacts will align. Figure 9 – Bracelet side view Pattern State Green (B1) Flashing Bracelet charging Bracelet fully charged or not Green (B1) on charger...
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Page 13: Using Your Bracelet With A Smart Device
6 USING YOUR BRACELET WITH A SMART DEVICE 6.1 Download and install the free “Corsano Trials” app onto your smart device. 6.2 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 2022-07-27 Ι Revision status: 10...
- 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 2022-07-27 Ι Revision status: 10...
- 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 2022-07-27 Ι Revision status: 10...
- Page 17 After you have signed up, you can Sign-In: As of 2022-07-27 Ι Revision status: 10...
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Page 18: Pairing Your Bracelet With A Smart Device
6.3 Pairing Your Bracelet with a Smart Device Upon first sign-in, user will be asked to pair a bracelet, follow the instructions. First, select “287-1B” in the list: As of 2022-07-27 Ι Revision status: 10... - 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 2022-07-27 Ι Revision status: 10...
- Page 20 Once the device is found, confirm The app will display the Serial Number by pressing on the pusher. On found. Please double check the S/N on successful pairing, the bracelet the device and click Confirm. The will light the orange LED up for devices is now paired to the app.
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Page 21: Troubleshooting The Bluetooth Connection
6.4 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
6.5 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
7 RECORD PATIENTS Click on “New Patient” Click on “Start Measurement” 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 The app will stop the measurement. At measurement, click on “Stop this stagethe note is still editable. Measurement” 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 2022-07-27 Ι...
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Page 25: Non-Medical Information
8 NON-MEDICAL INFORMATION The Corsano Trials app provides non-medical information like Activity: As of 2022-07-27 Ι Revision status: 10... - Page 26 Sleep: As of 2022-07-27 Ι Revision status: 10...
- Page 27 Heart Rate: As of 2022-07-27 Ι Revision status: 10...
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Page 28: Health App And Google Fit Integration
9 HEALTH APP AND GOOGLE FIT INTEGRATION The Corsano Trials 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 29: Clinical Performance
10 CLINICAL PERFORMANCE Definition Unit Range Acquisition Update Accuracy * Time interval Heart Rate Number of beats of the heart beats/minute 30-220 5-10 sec 1 sec HR is ±4 bpm MAD, per minute (bpm) ±5% MARD (at rest) RR Interval Elapsed time between two msec 300-2000 ms 5-10 sec... -
Page 30: 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 31: 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 32: Warranty
12 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. -
Page 33: Specification
Wireless Communication ..............BLE 5.0 Display LEDs ................... 1 green, 1 orange User action ..................pusher button PPG sensor are exposed on the back of the Corsano bracelet. The PPG sensor makes contact with the user’s skin. As of 2022-07-27 Ι Revision status: 10... -
Page 34: 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 35 Guidance and manufacturer’s declaration—electromagnetic immunity 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. Electromagnetic environment - Immunity test...
- Page 36 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 37 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 38: 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 39: Corsano Contact Information
16 CORSANO CONTACT INFORMATION Corsano Health B.V. Wilhelmina van Pruisenweg 35 2595 AN The Hague The Netherlands www.corsano.com As of 2022-07-27 Ι Revision status: 10...
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