Corsano CardioWatch 287-2 Скачать руководство пользователя страница 3

 
 

 As of 2022-11-17 

Ι Revision status: 12                       

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 
 

  

2  INTRODUCTION 

Thank you for purchasing the Corsano CardioWatch 287-2. Corsano CardioWatch 287-2 
not only analyses your heartbeat, but also your heart rhythm, oxygen saturation, 
respiratory rate, ECG, temperature and activity- simple and at any time. The bracelet has 
been validated in clinical studies and enables screening for irregular heartbeats (e.g. 
extrasystoles) as well as the presence of absolute arrhythmia with suspected atrial 
fibrillation (AF). However, irregular heartbeats (e.g. extrasystoles) and atrial fibrillation can 
only be diagnosed in accordance with the guidelines with an ECG of the thoracic wall, 
generally carried out by cardiologists. 
If you are feeling unwell or experience other troubling symptoms, please seek medical 
advice immediately. 

 

3  SAFETY INSTRUCTIONS 

This instruction manual provides you with important information about the Corsano 
CardioWatch 287-2 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 [email protected] before 
attempting to use this bracelet. For specific information about your own heartbeats, 
consult with your physician. 

3.1 

Intended Use

 

The CardioWatch 287-2 System is intended for reusable bedside, mobile and central multi-
parameter, physiologic patient monitoring of adult patients in professional healthcare 
facilities, such as hospitals or skilled nursing facilities, or their own home. It is intended for 
monitoring of patients by trained healthcare professionals. 

The CardioWatch 287-2 System is intended to provide visual and audible physiologic 
multi-parameter alarms. 

The CardioWatch 287-2 System is intended for temperature monitoring of the patient. 

The CardioWatch 287-2 System is intended for continuous monitoring of the following 
indices in adults: 

•  Pulse rate 
•  Oxygen saturation 
•  Respiration rate 
•  Temperature 
•  Movement  

The CardioWatch 287-2 System is intended for intermittent or spot-check monitoring, in 
adults, of:  

•  Non-invasive blood pressure  
•  Weight 
•  ECG 

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 

Содержание CardioWatch 287-2

Страница 1: ...As of 2022 11 17 Revision status 12 1 EN CardioWatch 287 2 Bracelet Instruction Manual...

Страница 2: ...11 7 USING YOUR BRACELET WITH A SMART DEVICE 13 7 1 Download and install the free CORSANO app onto your smart device 13 7 2 First time use 13 7 3 Pairing Your Bracelet with a Smart Device 18 7 3 1 Pa...

Страница 3: ...not understand these instructions or have any questions contact support corsano com before attempting to use this bracelet For specific information about your own heartbeats consult with your physici...

Страница 4: ...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 containi...

Страница 5: ...r physician before using this bracelet if you have severe blood flow problems or blood disorders DO NOT use this bracelet for any purpose other than measuring heartbeats During measurement make sure t...

Страница 6: ...OT 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 Wipe any dust off of the charger Unplug the charger when not...

Страница 7: ...c arrhythmia AFib for instance by third party medial applications 3 9 Cleaning and service life Use a lint free cloth moistened with warm water to clean the housing and casing of your device Use warm...

Страница 8: ...user to consult the instructions for use Applied Part TYPE BF Applied Part IEC 60417 5333 Indicates the manufacturer s catalogue number so the medical device can be identified Indicates the manufactu...

Страница 9: ...As of 2022 11 17 Revision status 12 9 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...

Страница 10: ...T 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 Magnet...

Страница 11: ...The LED will light up to indicate that charging has started While charging the Bracelet will not perform any measurement The polarity of the magnets in the bracelet and the charger will ensure that th...

Страница 12: ...ergy connection Orange B ON for 5 seconds Bracelet connected to a Smartphone Blue C ON Bracelet is performing an ECG measurement When the bracelet is close to the end of its battery autonomy the user...

Страница 13: ...status 12 13 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 ac...

Страница 14: ...As of 2022 11 17 Revision status 12 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...

Страница 15: ...As of 2022 11 17 Revision status 12 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...

Страница 16: ...evision status 12 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 conse...

Страница 17: ...As of 2022 11 17 Revision status 12 17 After you have signed up you can Sign In...

Страница 18: ...evision status 12 18 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...

Страница 19: ...22 11 17 Revision status 12 19 Press the pusher the orange LED will flash the bracelet is waiting for pairing Press on button in the app to start pairing After button is pressed app will look for the...

Страница 20: ...ful pairing the bracelet will light the orange LED up for 10 seconds and then turn it OFF The app is then ready to go Figure 8 APP Pairing complete When your bracelet is connected successfully to your...

Страница 21: ...in 6 Re open the app If these steps did not reconnect please proceed 1 Shut down your phone do not do restart completely shut the phone off and turn it back on This will fully reset the Bluetooth syst...

Страница 22: ...our phone s Airplane Mode off and on again 4 Re open the app If these steps did not reconnect please proceed 1 Shut down your phone do not do restart completely shut the phone off and turn it back on...

Страница 23: ...nt 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 Pl...

Страница 24: ...eps again to record other patients Confirm the stopping of the measurement by clicking on Yes When you want to stop the measurement click on Stop Measurement The app will stop the measurement and sync...

Страница 25: ...As of 2022 11 17 Revision status 12 25 9 NON MEDICAL INFORMATION The CORSANO app provides non medical information like Activity...

Страница 26: ...As of 2022 11 17 Revision status 12 26 Sleep...

Страница 27: ...11 17 Revision status 12 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...

Страница 28: ...ted by counting the number of R peaks in 6 seconds and multiply by 10 A pause in ECG is determined when baseline is stabilized and there is no R peak for more than 3 seconds The CardioWatch 287 2B can...

Страница 29: ...es The data and alarm indication are available for the physician on the Corsano portal On the portal the physicians can define the alarm levels conditions The delay to trigger the alarm condition depe...

Страница 30: ...etting 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...

Страница 31: ...gle Fit apps however doing so will limit the information available in your personal report The CORSANO app shares the following pieces of information with the Apple Health and Google Fit app Heart Rat...

Страница 32: ...on and low perfusion Body Temperature Temperature of the body at the measurement site Degree Celsius 35 45 C 30 min 1 min 0 3 C NOTES MAD Mean absolute difference MARD Mean absolute relative differenc...

Страница 33: ...eart rate value and displays a dotted line on the Heart Rate graph The operation of the pulse oximeter can also be verified by using a simulator device like the WhaleTeq HRS200 for example 1 Place the...

Страница 34: ...ition PPG sampling rate 32 Hz Motion sampling rate 32 Hz Flash Memory Size 256 Mbit Recording Continuous ECG Sampling rate 256 Hz Bandwidth 0 05 55 Hz Power Requirements Average current 1 2 mA Max cur...

Страница 35: ...ue 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 Informa...

Страница 36: ...ent guidance RF emissions CISPR 11 Group 1 The Corsano Bracelet uses RF energy only for its internal function Therefore RF emissions are very low and are not likely to cause any interference in nearby...

Страница 37: ...floors are covered with synthetic material the relative humidity should be at least 30 Electrical fast transient burs t IEC 61000 4 5 2 kV for power supply lines 1 kV for input outpu t lines 2 kV for...

Страница 38: ...the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol Conducted RF IEC 61000 4 6 150 kHz to 80 MHz NA Radiated RF IEC 610...

Страница 39: ...er of transmitter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz d 1 2 P 80 MHz to 800 MHz d 1 2 P 800 MHz to 2 5 GHz d 2 3 P 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1...

Страница 40: ...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 recycl...

Страница 41: ...nnect the equipment into an outlet on a circuit different from that to which the receiver is connected Consult the dealer or an experienced technician for help NOTICE This device complies with Part 15...

Страница 42: ...As of 2022 11 17 Revision status 12 42 17 CORSANO CONTACT INFORMATION Corsano Health B V Wilhelmina van Pruisenweg 35 2595 AN The Hague The Netherlands www corsano com...

Страница 43: ......

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