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Summary of Contents for Corsano CardioWatch 287-2B
- Page 1 CardioWatch 287-2B Bracelet & Mobile Patient App Instruction Manual Corsano Health B.V. 1912 Wilhelmina van Pruisenweg 35 2595 AN The Hague The Netherlands www.corsano.com info@corsano.com Bracelet Instruction Manual Ι As of 2023-08-17 Ι Revision status: 15...
- Page 2 PLEASE READ THE RELEVANT INSTRUCTION MANUALS BEFORE OPERATING THE SYSTEM. If any part of an Instruction Manual is not clear, contact Corsano Health for assistance. This Instruction Manual is provided electronically, if you wish to obtain a paper copy please contact Corsano Health.
- Page 3 the equipment or other property. RECOMMENDATION : A RECOMMENDATION statement provides a proposition or suggestion to user. CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician or other practitioner licensed by U.S. state law to use or order the use of this device.
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Page 4: Table Of Contents
LED Explanation ......................... 17 Cleaning & Disinfection ......................18 USING YOUR BRACELET WITH THE CORSANO APP ..............19 Download and install the Corsano App onto your smart phone........... 19 First time use – Sign Up ......................19 Sign In ............................20 Pairing Your Bracelet ......................... - Page 5 NON-INVASIVE BLOOD PRESSURE MEASUREMENT ............43 11.1 Pair the Blood Pressure Cuff to the Corsano APP ................ 43 11.2 Perform a calibration measurement with the Blood Pressure Cuff..........44 PRINCIPLE OF OPERATION ....................47 12.1 Pulse Rate principle of operation ....................47 12.2...
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Page 6: Introduction
The bracelet is intended for use in professional healthcare facilities, such as hospitals or skilled nursing facilities, or the home. The Corsano CardioWatch 287-2 System is also integrated with third-party devices for displaying and monitoring physiological signs (spot monitoring of: non-invasive blood pressure (CuffBP), lung function &... - Page 7 This instruction manual provides you with important information about the Corsano CardioWatch 287-2B Bracelet and App. These instructions are intended for both the Patient and the Healthcare Practitioner. The CardioWatch 287-2 System should only be used by and under the supervision of trained Healthcare Practitioners.
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Page 8: Safety Instructions
3 SAFETY INSTRUCTIONS To ensure the safe and proper use of the CardioWatch 287-2B Bracelet and App, READ and UNDERSTAND all of the safety and operating instructions. If you do not understand these instructions or have any questions, contact your Healthcare Practitioner or support@corsano.com... -
Page 9: Cautions
Movement, ambient light, and low perfusion may affect SpO2 and pulse rate calculation and accuracy. Corsano 287-2 System is not intended for use in calculating accurate SpO2 during periods of high motion, high ambient light, and low perfusion conditions. -
Page 10: Notes
A secondary clinical benefit is that the Healthcare Practitioner may decide, based on the patients therapy, that the Corsano App in Patient Mode should display patient trending information, for instance Patient Activity (Motion Levels & Steps) to encourage the patient to be more active or to better adhere to Healthcare Practitioner instructions. -
Page 11: Symbols
Indicates the need for the User to consult the instructions for use Applied Part (Corsano Bracelet) TYPE BF Applied Part (IEC 60417-5333) Indicates the manufacturer's catalogue number so the medical device can... - Page 12 Device is MR-unsafe Bracelet Instruction Manual Ι As of 2023-08-17 Ι Revision status: 15...
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Page 13: Contents / Product Includes
Charger (CS-287CH-1) One package box with instructions: Instruction Manual (IFU Corsano CardioWatch 287-2 Bracelet) IMPORTANT : the USB AC / DC Power Supply (USB Adapter) is not provided. Refer to §16.3 - AC-DC Power Supply (USB Adapter) for the minimum specification. -
Page 14: Know Your Bracelet
6 KNOW YOUR BRACELET 6.1 Back and Side of the bracelet Back and Side view of Bracelet (A) Green LED (B) Orange LED (C) Blue LED Back and bottom of the bracelet Back view of Bracelet (D) PPG Sensor (E) Charge contacts (F) Magnets for charge cable holding Bracelet Instruction Manual Ι... -
Page 15: Warnings / Cautions / Recommendations
6.3 WARNINGS / CAUTIONS / RECOMMENDATIONS Stop using this bracelet and consult with your Physician or Healthcare Practitioner if you experience skin irritation or discomfort. DO NOT apply the wearable device on open wounds, sores, or cuts; the device is only intended for contact with intact skin. -
Page 16: Charging The Bracelet
charger when in RF restricted areas. For further information on potential restrictions, please refer to documentation on Bluetooth usage provided by the FCC. If the device is removed from Bluetooth range, it will store signal data for a maximum of 24 hours. After 24 hours, the oldest data will be erased. Charging the bracelet Remove the Bracelet from the wrist prior to charging. -
Page 17: Led Explanation
are in normal working condition. Worn out or defective batteries can significantly reduce battery capacity or the operating time. DO NOT use the charger if the bracelet or the charger cable is damaged. If the bracelet or the cable is damaged, unplug the charger immediately. DO NOT charge the device from a multi-outlet plugs. -
Page 18: Cleaning & Disinfection
During patient use, users (Patients & HCP) should regularly check the condition of the CardioWatch 287-2B Bracelet, USB Charger Cable & Strap and clean and / or disinfect as necessary. Prior to cleaning / disinfection, dissemble the strap from the bracelet, and remove the USB charge cable. -
Page 19: Using Your Bracelet With The Corsano App
7 USING YOUR BRACELET WITH THE CORSANO APP 7.1 Download and install the Corsano App onto your smart phone. 7.2 First time use – Sign Up Select “Sign Up” to create a user account (2) Enter First Name, Last name, Email... -
Page 20: Sign In
Enter: • Your password • Your password again • The received code Press “Create account” Create account 7.3 Sign In Once you have created a user account, you can sign-in in the APP. Select “Sign In” (1) Choose Sign-In Bracelet Instruction Manual Ι As of 2023-08-17 Ι Revision status: 15... -
Page 21: Pairing Your Bracelet
Enter: • Email • Password Press “Sign In” Sign-In 7.4 Pairing Your Bracelet Upon first sign-in, user will be asked to pair a bracelet, follow the instructions: First, select your bracelet in the list: 287-2B Pair Bracelet Bracelet Instruction Manual Ι As of 2023-08-17 Ι Revision status: 15... - Page 22 Wait for the app to find the bracelet Connect the charger and press Start Pairing Remove charging cable to complete pairing Bracelet Instruction Manual Ι As of 2023-08-17 Ι Revision status: 15...
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Page 23: Wearing Optimization
The sensing side of the CardioWatch 287-2B Bracelet should be placed in direct contact with the skin, on the top side of the wrist. The CardioWatch 287-2B Strap should be snug, but not too tight – just tight enough to ensure the bracelet makes solid contact with your skin. -
Page 24: Bracelet Direction
7.5.1 Bracelet Direction Bracelet Direction 7.5.2 Tightening Check Bracelet Positioning Bracelet Instruction Manual Ι As of 2023-08-17 Ι Revision status: 15... -
Page 25: Optional Wearing Optimization
7.6 Optional Wearing Optimization To check if the CardioWatch 287-2B Bracelet is well positioned on your wrist and if the bracelet is tight enough, open the Main Setting Menu and select “Wearing Optimization”. Then follow instructions on screen. Wearing Optimization... -
Page 26: Corsano App Settings (Patient Mode)
7.7 Corsano App Settings (Patient Mode) In the App, you can open the Settings Menu You can see your profile data and modify if by clicking on the icon on the top left corner. needed. You can see the information about the app These parameters are important for the and device. -
Page 27: Troubleshooting The Bluetooth Connection
7.8 Troubleshooting the Bluetooth Connection If the connection between the bracelet and app is lost, a red “X” will appear: Please follow instructions: 1. Make sure your phone is nearby 2. Check if watch is charged 3. Check if GPS is on (for Android) 4. -
Page 28: Troubleshooting The Cloud Connection
7.9 Troubleshooting the Cloud Connection If the connection between the app and the cloud is lost, a red “X” will appear: Please follow instructions: 1. Make sure your phone is connected to internet 2. Force quit the app on your phone 3. -
Page 29: External Devices
& spirometry. Refer to the User Instructions provided with each external device. The following provides only summary information, associating the external device and the Corsano System. It is not intended to replace the external device instructions for use. Verify systematically that the measurements made by the external devices are correct and that no alarms or technical errors have occurred;... -
Page 30: Cuff Blood Pressure
Spot-check monitoring of blood pressure can be performed with the external cuff blood pressure monitor TMB-2084-A manufactured by Transtek (FDA K220676), which connects to the Corsano App using Bluetooth technology through an API provided by Transtek. If the non-invasive blood pressure monitor is connected, it will transmit medically accurate readings of bloodpressure to the Corsano App, Cloud and Patient Portal. - Page 31 Specification spirometry: Sensing Method External MIR Spirobank with bi-directional digital turbine Parameters FEV1 FEV6 FEV1/FVC ratio (derived from previous meausrements) Flow Range 0 to 10 L +/- 16 L/s Volume Accuracy +/- 2.5% or 0,05 L Flow Accuracy +/- 5.0% or 0,20 L/s Specification spirometry Parameter Accuracy...
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Page 32: Weight Scale
2012-B manufactured by Transtek (FDA D1545656), which connects to the Corsano App using Bluetooth technology through an API provided by Transtek. If the weight scale is connected, it will transmit accurate readings of weight to the Corsano App, Cloud and Patient Portal. -
Page 33: App Screens
9 APP SCREENS By default, the Corsano App in Patient Mode does not display information. In particular cases, your Healthcare Practitioner may decide based on therapy, that your app should display trending information, for instance Activity (Motion Levels & Steps) Information can be displayed to encourage you to be more active. - Page 34 The following figure gives a summary view of the available Patient Mode Screens: Pulse rate SpO2 Body temperature Activity Respiration rate NIBP Spirometry Weight NOTE: Your Healthcare Practitioner determines which screens will be seen in the Patient App via the Configuration Panel in the Web Portal (for HCP only). Bracelet Instruction Manual Ι...
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Page 35: Perform An Ecg
10 PERFORM AN ECG 10.1 ECG measurement To record an ECG, launch the measurement from the Dashboard screen and follow the steps. You can watch the tutorial video on www.corsano.com, Support/Getting Started/Tutorial videos: https://corsano.com/knowledge-base/movies/ Press “Start”. In the Dashboard menu, Sit on a chair with your arms press “START ECG... - Page 36 Sit still, don’t move, don’t talk, At the end of the recording, try to relax. Muscular tension the APP processes the may generate a noisy signal. measurement. It may take The recording lasts about several seconds. 40s. Bracelet Instruction Manual Ι As of 2023-08-17 Ι Revision status: 15...
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Page 37: Ecg Troubleshooting
Problem: ECG Interrupted Solution: • Make sure the device is charged • Keep the Bracelet close to the phone running the Corsano APP Problem: ECG Error Solution: • Keep still, don’t move, don’t talk. This can generate artefacts on the ECG signal. - Page 38 Problem: My ECG signal is inverted Solution: • You wear the Bracelet on the wrong wrist. Change wearing wrist. Do the measurement again. • Or, select the right wearing wrist in the APP settings. (From Dashboard, press Menu icon in top left corner, scroll down to User Profile, edit Wrist position).
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Page 39: Ecg Results
10.3 ECG Results To see the results of the ECG recordings: • Press on the ECG window, in the APP Dashboard, to access the history of recordings • Press to select your recording. Tap on the ECG window, in Select you recording by You can go through the the APP Dashboard, to tapping on it. - Page 40 The “Enhance” button Unfiltered signal Inverted signal enables to show the filtered or unfiltered signal. The “Invert” button enables to show the inverted signal. Bracelet Instruction Manual Ι As of 2023-08-17 Ι Revision status: 15...
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Page 41: Ecg Warning
You can delete the A full report is provided, generated by a CE MDR certified measurement by pressing Cloud based ECG algorithm, by Cardiolyse. “Delete this measurement”. You can export a PDF report by pressing “Download PDF report”. 10.4 ECG Warning The ECG recording cannot detect heart attacks. -
Page 42: Ecg Cautions
10.5 ECG Cautions Presence of Atrial Fibrillation (AF) in your ECG results may represent only potential findings. If you have symptoms or concerns, please contact your general practitioner. If you believe you are experiencing a medical emergency, contact emergency services. Error in ECG recording can be due to too much artefact or noise in the signal, because of too much movement during recording, bad wearing of the device or bad electrode contact. -
Page 43: Non-Invasive Blood Pressure Measurement
Corsano App to transmit the calibration data. 11.1 Pair the Blood Pressure Cuff to the Corsano APP Please follow the steps to pair the external Blood Pressure Cuff to the Corsano App. Press “Blood Pressure In the Dashboard, select the Scroll down to reach “Manage Devices”... -
Page 44: Perform A Calibration Measurement With The Blood Pressure Cuff
11.2 Perform a calibration measurement with the Blood Pressure Cuff Please follow the steps to perform a calibration measurement with an external Blood Pressure Cuff. You can watch the tutorial video on www.corsano.com, Support/Getting Started/Tutorial videos: https://corsano.com/knowledge-base/movies/ Bracelet Instruction Manual Ι As of 2023-08-17 Ι Revision status: 15... - Page 45 USB cable plugged to a power source. Sit on a chair, relax. Put the Cuff on your arm. The Blood Pressure Cuff and the Corsano Bracelet on opposite arms. The BP Cuff and Bracelet shall not be worn on the same arm!
- Page 46 30s. The calibration of the Non-Invasive Blood Pressure with the external Blood Pressure Cuff monitor shall be performed once per month. Please follow the instructions of your Corsano APP. Bracelet Instruction Manual Ι As of 2023-08-17 Ι Revision status: 15...
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Page 47: Principle Of Operation
This light is then reflected and captured by the photodiodes in Corsano Bracelet to measure the blood stream. The results of the PPG signal depend primarily on the flow of blood to the capillary vessels in each heartbeat. The waveform of the PPG signal indicates the changes in pulsatile blood flow from which the detection of signal peaks allows the calculation of peak-to-peak intervals. -
Page 48: Spo2 Principle Of Operation
Pulse Rate Specification 12.2 SpO2 principle of operation Corsano Bracelet utilizes the Photoplethysmography (PPG) sensor photodiodes to capture reflected light calculates your functional oxygen saturation (SpO2) using pulse oximetry on the wrist, a non-invasive technique to monitor oxygenation. It monitors the percentage of hemoglobin that is oxygen-saturated. -
Page 49: Respiration Rate Principle Of Operation
Steps are calculated by the proprietary algorithm based on the intensity and frequency of your acceleration data. Accuracy of Steps with Corsano Bracelet will be studied in February-March by RadboudMC versus Reference Device FDA Cleared Actigraph CenterPoint Watch. NOTE : the Activity (Motion Levels & Steps) parameter is considered a software function solely intended to monitors and records daily energy expenditure and cardiovascular workout activities to allow awareness of one’s exercise activities... -
Page 50: Temperature Principle Of Operation
The Corsano Bracelet makes use of the PPG sensor, which includes the emission of light by LEDs to the skin and the measurement of reflected light by photodiodes. The PPG signal is strongly dependent on the amount of light that is absorbed by the arterial blood in the tissue and reflectance on arterial/arteriole blood flow. - Page 51 Correlation between Corsano Non-Invasive Blood Pressure measurement and the reference (Invasive measurement, Fysicon) Bland-Altman plot comparing the Corsano Non-Invasive Blood Pressure measurement and the reference (Invasive measurement, Fysicon) Specification claims of Non-Invasive Blood Pressure: Sensing Method Derived from PPG signal...
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Page 52: Ecg
The Corsano Bracelet 1-Lead ECG is composed of a front-end analogue pass-band filter (0.05-55 Hz). The electrical signal is sampled at 256 Hz on 15 bits, on an AC dynamic range of 200mVp-p. The raw signal is sampled by the Bracelet and sent to the Corsano APP and Cloud. -
Page 53: Clinical Performance
Accuracy of CardioWatch 287-2 during motion and different positions of the body, with or without hypoxia. Location: Complementair Medisch Centrum (CMC) Europe, Belgium. The Corsano CardioWatch 2872 system was calibrated with reference oximeter Nellcor PM10. See Bland-Altman plot next page comparing the CardioWatch 287-2 Software-derived SpO2 and the Nellcor reference SpO2 pooled over all subjects at rest. -
Page 54: Temperature
Bland Altman SpO2 CardioWatch 287 versus Nellcor PM10 Bland-Altman plot for CW2 SpO2 and CO-oximetry SaO2 in the invasive study under motion. Accuracy of SpO2 of CW2 compared to CO-SaO2 for all subjects, for pooled conditions, was 1.63 Arms with Bias of 0.05 (-0.14, 0.23) %, N=287. Bland Altman SpO2 CardioWatch 287 versus SaO2 13.3 Temperature Accuracy of CardioWatch 287-2 Skin Temperature was measured by testing laboratory... -
Page 55: Activity (Steps)
13.4 Activity (Steps) RadboudMC, Nijmegen, The Netherlands compared measured steps per minute determined by the Cardiowatch with steps per minute determined with the Actigraph CENTREPOINT Insight Watch. Accuracy of was 1,2 Arms with Bias of 0.7 (0.6, 0,7) Steps, N=3695. Accuracy Steps 13.5 Respiration Accuracy was measured in multiple studies, here are results of two studies:... -
Page 56: 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 57: 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 58: Warranty
Pruisenweg 35, 2595 AN The Hague, The Netherlands or its authorized representative. Corsano Health shall not have any responsibility in the event of loss or damage in transit. Corsano Health’s obligation or liability under this warranty does not include any... -
Page 59: Technical Specifications
16 TECHNICAL SPECIFICATIONS 16.1 Corsano Mobile App Minimum requirements for mobile device Operating Systems: • iO 14.5 or higher • Android 8.0 or higher 16.2 Corsano Bracelet PPG Sensor Characteristics PPG ....................Red, IR, Green PPG LED/Photodiode number ........................ -
Page 60: Ac-Dc Power Supply (Usb Adapter)
USB adapter must conform to UL/cUL 60601-1 with the following characteristics: • Input voltage: AC 100-240V, 50/60hz • Output voltage: DC 5V (+/- 5%) • Output current: 500 mA (minimum) The following USB Adapter Model has been validated by Corsano : Company CUI Inc Manufacturer Part Number SWM6-5-NH-I38 For any other models, please confirm the conformity to the above standards.Should... -
Page 61: Electrical Safety And Electromagnetic Compatibility
30cm (12 inches) to any part of the Corsano Bracelet, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. - Page 62 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 63 Guidance and manufacturer’s declaration—electromagnetic immunity 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. Immunity test IEC 60601 test...
- Page 64 Guidance and manufacturer’s declaration—electromagnetic immunity 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. Immunity test IEC 60601 test...
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Page 65: Legal Notice For Fcc And Ised
The device can be operated at a distance of 0-20 cm or superior. 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: “Harmful interference” is defined in 47 CFR §2.1... -
Page 66: Disposal / End Of Life
Risk of infection. The Bracelet & USB Charge Cable must be cleaned & disinfected before disposal. The Bracelet contains a lithium-ion battery. Do not incinerate the device or place in a trash compactor. Do not puncture the battery. 20 CORSANO CONTACT INFORMATION Corsano Health B.V. Wilhelmina van Pruisenweg 35 2595 AN The Hague The Netherlands www.corsano.com...
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