Corsano CardioWatch 287 Instruction Manual
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Corsano CardioWatch 287 Instruction Manual

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CardioWatch 287
Bracelet Instruction Manual
2020-10-08
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  • Page 1 CardioWatch 287 Bracelet Instruction Manual 2020-10-08 "!

  • Page 2: Table Of Contents

    Charging the bracelet ........................10 USING YOUR BRACELET WITH A SMART DEVICE ..............12 Download & install the “CORSANO PREVENTICUS SMART IN OAC” app onto your smart device. . 12 First time use ..........................12 Register for participation in the Smart in OAC – AFNET 9 study ............ 15 Pairing Your Bracelet with a Smart Device ...................

  • Page 3: Introduction

    Environments of Use: Hospital and Home Patient Population: Adult !", -'.'/0/%1)2%()$%+3'.&/4%) Remove this bracelet and other components from the packaging and inspect for damage. If this bracelet or any other components is damaged, DO NOT USE and contact Corsano. 2020-10-08...

  • Page 4: Data Transmission

    Read the Important Safety Information in this instruction manual before using this bracelet. Follow this instruction manual thoroughly for your safety. 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.

  • Page 5: Handling And Usage

    • 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. • Plug the charger into the appropriate USB outlet. DO NOT use in a multi-outlet plug. •...
  • Page 6 • When handling the charger cable: DO NOT damage it. DO NOT break it. DO NOT tamper with it. DO NOT forcibly bend or pull it. DO NOT twist it. DO NOT use it if it is gathered in a bundle. DO NOT pinch it. DO NOT place it under heavy objects.

  • Page 7: Symbols

    4 SYMBOLS These instructions for use contain the following symbols (color and size may vary): Symbol Meaning Indicates the device manufacturer Warning Indicates the need for the user to consult the instructions for use for important information such as warnings and cautions. A warning is always related to safety.

  • Page 8: Contents / Product Includes

    5 CONTENTS / PRODUCT INCLUDES Bracelet (CS-287BR) Charger (CS-287CH-1) Instruction Manual (CS-287IFUEN-1) 2020-10-08...

  • Page 9: Know Your Bracelet

    6 KNOW YOUR BRACELET ?"# @74%&)4A)&;')B72.'='&) (A) Ambient Temperature Sensor (B) LEDs (C) Button ?", C2.D)2%()B4&&48)4A)&;')B72.'='&) (D) Temperature Sensors (E) PPG Sensor (F) Magnets (G) Charge Contacts 2020-10-08...

  • Page 10: Charging The Bracelet

    ?"! :;271/%1)&;')B72.'='&) 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 LEDS will light up to indicate that charging has started. 2020-10-08 "+!
  • Page 11 The polarity of the magnets in the bracelet and the charger will ensure that the charger contacts will align. Pattern State Green (B1) Flashing Bracelet charging Bracelet fully charged Green (B1) or not on charger 2020-10-08 ""!

  • Page 12: Using Your Bracelet With A Smart Device

    7 USING YOUR BRACELET WITH A SMART DEVICE E"# 54F%=42()G)/%+&2==)&;')H:I-JKLI)M-NONL6$:*J)JPK-6)$L)IK:Q)233)4%&4) R4S7)+827&)('0/.'") The “CORSANO PREVENTICUS SMART IN OAC” app is available in the App Store and Google Play. Minimum requirements for use of the app: • iOS: version 12.2 or higher •...
  • Page 13 Register Enter your personal registration code (see invitation letter) for the Smart in OAC – AFNET 9 study and create a personal password. Please tap on “Register” to continue. Please contact your study site in case of any questions or if you require support. You can access a website with contact details and further information by tapping on the Smart in OAC –...
  • Page 14 You will receive a message if your account has been successfully created and you can start the enrolment process for the study by tapping the button (see section 7.3). 2020-10-08 "%!

  • Page 15: Register For Participation In The Smart In Oac - Afnet 9 Study

    E"! -'1/+&'7)A47)327&/./32&/4%)/%)&;')J827&)/%)IK:)T)K@LN6)U)+&S(R) Before you start, it is necessary to confirm that you have read and understood the participant information and the privacy notice by ticking the boxes. Then, please tap on “Confirm”. 2020-10-08 "&!
  • Page 16 Afterwards, please enter your year of birth, your sex, and your ethnic background (optional). 2020-10-08 "'!
  • Page 17 Please answer several health-related questions (blood-thinning medication, atrial fibrillation, hypertension, etc.) on the following screens. You can tap on for further information (e.g. a list of blood-thinning medication). 2020-10-08 "(!
  • Page 18 Next, you will be asked to evaluate your quality of life using the EQ-5D™ Health Questionnaire (© EuroQol Research Foundation). If you do not want to answer these questions, you can skip the questionnaire. Under each of the five headings (Mobility, Self- care, Usual activities, Pain/Discomfort, Anxiety/Depression), please tick the ONE box that best describes your health TODAY.
  • Page 19 On the following screen you can select how you want to receive your measurement bracelet. In this context, you have two options. The first possibility is the delivery of the bracelet via postal service. The second option is to receive it at a personal visit at the study site.
  • Page 20 You will receive a summary of your entries. Please check and tap on “Confirm” to go on. 2020-10-08...
  • Page 21 You will receive a message that you meet the inclusion criteria and are able to participate in the study, or that you do not meet these criteria. Please tap on “Continue” or “Close App”, respectively. 2020-10-08 #"!
  • Page 22 Please enter your name, address, and contact data and select “Continue”. Please note, that only the study site can access your personal data so they can contact you if necessary. 2020-10-08...
  • Page 23 Please read the informed consent form (tap on to enlarge) and click on the signature field to sign with your fingertip. Please select “Continue”. 2020-10-08...
  • Page 24 “Download” button. To complete the enrolment process, it is important to confirm (by checking the box) that you are aware that the Corsano Health B.V. and Preventicus GmbH will not be able to provide you the informed consent form afterwards.
  • Page 25 You will receive a message if the enrolment was successful. Please tap on “Close App”. 2020-10-08 #&!

  • Page 26: Pairing Your Bracelet With A Smart Device

    E"9 M2/7/%1)V4S7)C72.'='&)F/&;)2)J827&)5'0/.') The connection between the measurement bracelet and your smart device is established via Bluetooth. Therefore, it is necessary to activate Bluetooth on your smartphone (please refer to the instruction manual). Please follow the instructions below for pairing: Charge the bracelet for two hours before pairing the first time. The bracelet is in Shipping Mode during transportation.
  • Page 27 Once the device is found, please The app will display the Serial Number confirm by pressing the button. On found. Please double check the S/N on successful pairing, the bracelet will light the device and click Confirm. The the orange LED up for 10 seconds and devices is now paired to the app.

  • Page 28: Troubleshooting The Bluetooth Connection

    E"> 674SB='+;44&/%1)&;')C=S'&44&;):4%%'.&/4%) 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 bracelet is charged 3. Check if GPS is on (Android only) 4.

  • Page 29: Troubleshooting The Cloud Connection

    E"? 674SB='+;44&/%1)&;'):=4S():4%%'.&/4%) 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 30: Smart In Oac - Afnet 9 Status Screen

    E"E J827&)/%)IK:)T)K@LN6)U)+&2&S+)+.7''%) In case you have successfully completed the study enrolment (see section 7.3) and pairing of your measurement bracelet (see section 7.4) the screen below will be displayed. You can switch between to the Activity screen (see section 7.9) by selecting the tab at the bottom of the screen.

  • Page 31: End Of Screening Period

    E"W )N%()4A)J.7''%/%1)M'7/4() The screening period of the Smart in OAC – AFNET 9 study ends after 8 weeks and you will receive the message below. However, you are still free to use your bracelet in the Activity (see section 7.9) mode. Please select “Close App” and reopen it if you want to enter the Activity mode.

  • Page 32: Activity Screen

    E"U K.&/0/&R)+.7''%) If you have successfully completed the pairing of your measurement bracelet (see section 7.4) you can enter the Activity screen by selecting the icon on the bottom right. In this case, the screen below will be displayed. Here you will get a summary of the steps you made across the day.

  • Page 33: Specification

    Measuring accuracy Heart Rate ................ +/- 3 BPM compared to ECG RR interval ................ +/- 50ms compared to ECG PPG sensor are exposed on the back of the Corsano bracelet. The PPG sensor makes contact with the user’s skin. 2020-10-08...

  • 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 8:0J>3@.!>3J!/>3:E>@B:9.9T1!J.@A>9>B023U.A.@B92/>C3.B0@!0//:30BD! 4291>32!L9>@.A.B!01!03B.3J.J!E29!:1.!03!B=.!.A.@B92/>C3.B0@!.3H0923/.3B!1;.@0E0.J!L.A2IF!<=.! @:1B2/.9!29!B=.!:1.9!2E!4291>32!L9>@.A.B!1=2:AJ!>11:9.!B=>B!0B!01!:1.J!03!1:@=!>3!.3H0923/.3BF! PA.@B92/>C3.B0@!.3H0923/.3B!N! 5//:30BD!B.1B! 5P4!'+'+"!B.1B! 42/;A0>3@.!A.H.A! C:0J>3@.! A.H.A! PA.@B921B>B0@! -A2291!1=2:AJ!L.!I22JG!@23@9.B.G!29! V01@=>9C.! Y'!KR!@23B>@B! @.9>/0@!B0A.F!5E!EA2291!>9.!@2H.9.J!I0B=! Y'!KR!@23B>@B! WP6VX!5P4! Y)!KR!>09! 1D3B=.B0@!/>B.90>AG!B=.!9.A>B0H.! Y)!KR!>09! '"+++N%N#! =:/0J0BD!1=2:AJ!L.!>B!A.>1B! $+ZF! Y#!KR!E29! Y#!KR!E29!;2I.9! PA.@B90@>A!E>1B! [>031!;2I.9!M:>A0BD!1=2:AJ!L.!B=>B! ;2I.9! 1:;;AD!A03.1! B9>310.3BSL:91 2E! >! BD;0@>A! @2//.9@0>A! 29! =21;0B>A! 1:;;AD! Y"!KR!E29! B!5P4!'"+++N .3H0923/.3BF! A03.1! 03;:BS2:B;:B!A03.1! %N&! Y"!KR!E29!
  • Page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d = 1.2 CP d = 1.2 CP 80 MHz to 800 MHz 9':#2$' 71'%#(,)%!>?! :A9!BCD!,1!E9! d = 2.3 CP 800 MHz to 2.5 GHz' G!H-*/! 567!8:999=@=8! FCD!

  • Page 37: Disposal Of The Device

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d = 1.2 d = 1.2 d = 2.3 √ √ √ 9K9:! 9K:J! 9K:J! 9KJG! 9K:! 9KGE! 9KGE! 9KUG! :KJ! :KJ! JKG! GKE!

  • Page 38: Corsano Contact Information

    11 CORSANO CONTACT INFORMATION Corsano Health B.V. Isaac da Costalaan 20 1401BH Bussum The Netherlands www.corsano.com 2020-10-08...

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