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Corsano CardioWatch 287-1B Instruction Manual

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CardioWatch 287-1B
Bracelet Instruction Manual
As of 2021-11-23 Ι Revision status: 9
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Summary of Contents for Corsano CardioWatch 287-1B

  • Page 1 CardioWatch 287-1B Bracelet Instruction Manual As of 2021-11-23 Ι Revision status: 9...

  • 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 Troubleshooting the Bluetooth Connection ................

  • Page 3: Introduction

    3 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

    Keep for future reference. For specific information about your own heartbeats, CONSULT WITH YOUR PHYSICIAN. • 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.

  • Page 5: Handling And Usage

    3.4 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. 3.8 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 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 2021-11-23 Ι Revision status: 9...

  • 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) As of 2021-11-23 Ι Revision status: 9...

  • Page 10: Know Your Bracelet

    6 KNOW YOUR BRACELET 6.1 Front of the bracelet (A) Ambient Temperature Sensor (B) LEDs (C) Pusher button Figure 4 – Front view of Bracelet 6.2 Back and bottom of the bracelet (D) Temperature Sensors (E) PPG Sensor (F) Magnets (G) Charge Contacts Figure 5 –...

  • Page 11: Charging The Bracelet

    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. 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...

  • 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 2021-11-23 Ι Revision status: 9...
  • 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 2021-11-23 Ι Revision status: 9...
  • 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 2021-11-23 Ι Revision status: 9...
  • Page 17 After you have signed up, you can Sign-In: As of 2021-11-23 Ι Revision status: 9...

  • Page 18: Pairing Your Bracelet With A Smart Device

    7.3 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 2021-11-23 Ι Revision status: 9...
  • 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 2021-11-23 Ι Revision status: 9...
  • 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.

  • 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: Non-Medical Information

    8 NON-MEDICAL INFORMATION The CORSANO app provides non-medical information like Activity: As of 2021-11-23 Ι Revision status: 9...
  • Page 24 Sleep: As of 2021-11-23 Ι Revision status: 9...
  • Page 25 Heart Rate: As of 2021-11-23 Ι Revision status: 9...

  • Page 26: Premium Service

    9 PREMIUM SERVICE The CORSANO app offers Preventicus Heartbeats as a Premium Service. User needs to select a plan: As of 2021-11-23 Ι Revision status: 9...

  • Page 27: Preventicus Heartbeats

    10 PREVENTICUS HEARTBEATS The CORSANO app provides seamless integration with Preventicus Heartbeats, a CE Class IIa certified medical device to analyse your heartbeat, but also and especially your heart rhythm. 10.1 Purpose The purpose of Preventicus Heartbeats is to detect signs of the presence of cardiac arrhythmias in a non-clinical environment.

  • Page 28: Intended Use

    A basic distinction should be made between AF detection (screening or progress monitoring) and subsequent AF diagnosis. AF should be exclusively diagnosed with an ECG of the thoracic wall, generally performed by cardiologists, in accordance with the guidelines. Preventicus apps are not intended for the final diagnosis of AF with therapeutic implications, but exclusively for AF screening or AF progress monitoring without therapeutic implications.

  • Page 29: Measuring Principle: Basics Of The Pulse Curve Analysis

    hard drive, memory card). 10.6 Measuring principle: basics of the pulse curve analysis Preventicus Heartbeats is used to capture the so-called pulse curve. Signal analytical methods are then used to derive the pulse curve from the PPG signal, in a similar way to the medical procedure photoplethysmography.
  • Page 30 Upon acceptance of the purpose, including warnings, Terms and Conditions and Privacy Policy, the following screen will appear: • Sequences with irregular results are marked in the heart rate graph with a yellow or red dot. Dots can be tapped to display the json result, plus a PDF can subsequently be pulled.

  • Page 31: Interpretation Of The Results

    10.8 Interpretation of the results Traffic light color Meaning Regular heart rhythm and normal heart rate Green Slight arrhythmia (>5% of all beats are irregular) and/or a Yellow slightly increased or decreased heart rate Absolute arrhythmia with suspected atrial fibrillation and/or a significantly increased or decreased heart rate (tachycardia/bradycardia).

  • Page 32: Overview Of The Measurement Report

    10.9 Overview of the measurement report After you select a measurement you will receive your result as a summary measurement report. This includes the recorded pulse curve, the heart rate (bpm) over time and detailed information about the heart rhythm. The measurement report is made up of three sections (see Fig.
  • Page 33 Fig. 8.9.2 Summarised results of the heart rhythm analysis and heart rate in beats per minute (bpm) over the entire measurement of a report with slight arrhythmia Positive peaks result from irregular heartbeats, which have a significantly reduced time interval from the previous heartbeat compared to the average. Negative peaks in the pulse rate, on the other hand, indicate a significantly greater time interval between the irregular heartbeat and the previous normal heart rate, compared to the average.

  • Page 34: Measurement Reportlist

    Blue bars in the pulse curve (see Fig. 8.9.5) indicate an automatically detected disruption, which could be caused by movement, environmental light or camera readjustments. Fig. 8.9.5 Original pulse curve of the measurement report with detected disruption (blue bar) 10.10 Measurement reportlist After each measurement, the reports are stored in a list and can be viewed via the menu item “My results”.
  • Page 35 As of 2021-11-23 Ι Revision status: 9...
  • Page 36 To better understand how to read such a report, see the video guide in the "My reports” area. The list shows the reports and their main information in sequence: heart rate measurement, the corresponding traffic light color of the measurement, comments and time of the measurement.

  • Page 37: Telecare Reportlist

    10.11 Telecare reportlist If you have one or more reports with suspected mild arrhythmia (yellow traffic light) or absolute arrhythmia (red traffic light), you have the option to send these reports to the Telecare service for a fee. The Telecare service offers you a direct medical assessment of your measurements by Telecare employees who specialise in heart rhythm analyses of heart rate data.
  • Page 38 In addition, the General Terms and Conditions and Privacy Policy of the Telecare service can be found in this section. You can also share the detailed view of the Telecare report with others. To do this, select a Telecare report from the list and go to the detailed view. Tap the “Share” button to subsequently receive a selection of services to send the report or store it on your smartphone outside of the app.

  • Page 39: Telecare Order Report

    Telecare order report 10.12 To order a Telecare report you have to be in the ”My reports” list. Next, select the "Send" (1) icon. You can send a single measurement or up to 5 measurement reports. Single measurement: select "Single measurement" if you only want to send one report. Keep in mind that you can send each report only once.

  • Page 40: 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 41: Clinical Performance

    12 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 42: 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 2021-11-23 Ι Revision status: 9...

  • Page 43: 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 44 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 45 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 46 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...

  • Page 47: 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 48: 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 2021-11-23 Ι Revision status: 9...

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