Corsano CardioWatch 287-2 User manual

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EN
CardioWatch 287-2
Bracelet & Corsano App
Instruction Manual

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Table of Contents ..........................................................................................................................2
1INTRODUCTION ......................................................................................................................4
2SAFETY INSTRUCTIONS ...........................................................................................................4
2.1 Intended Use...............................................................................................................................4
2.2 Receiving and Inspection .............................................................................................................4
2.3 Data Transmission .......................................................................................................................5
2.4 Handling and Usage .....................................................................................................................6
2.5 Charger Handling and Usage ........................................................................................................6
2.6 Warnings.....................................................................................................................................7
2.7 Residual risks...............................................................................................................................7
2.8 Clinical benefit.............................................................................................................................7
3SYMBOLS................................................................................................................................8
4CONTENTS / PRODUCT INCLUDES............................................................................................9
4.1 Receiving and Inspection .............................................................................................................9
4.2 Contents......................................................................................................................................9
5KNOW YOUR BRACELET ........................................................................................................10
5.1 Back and Side of the bracelet .....................................................................................................10
5.2 Back and bottom of the bracelet ................................................................................................10
5.3 Data Transmission .....................................................................................................................11
5.4 Charging the bracelet.................................................................................................................12
5.5 LED Explanation.........................................................................................................................13
5.6 Cleaning ....................................................................................................................................14
6USING YOUR BRACELET WITH THE CORSANO APP .................................................................15
6.1 Download and install the Corsano App onto your smart device...................................................15
6.2 First time use –Sign Up..............................................................................................................15
6.3 Sign In .......................................................................................................................................16
6.4 Pairing Your Bracelet .................................................................................................................17
6.5 Troubleshooting the Bluetooth Connection ................................................................................19
6.6 Troubleshooting the Cloud Connection.......................................................................................20
6.7 Corsano App Settings (Patient Mode).........................................................................................21
7APP SCREENS........................................................................................................................22
8PERFORM AN ECG.................................................................................................................24
9HEALTH APP AND GOOGLE FIT INTEGRATION........................................................................25
10 CLINICAL PERFORMANCE...................................................................................................26
11 CYBERSECURITY.................................................................................................................28
11.1 Information Security Management System.................................................................................28
11.2 About password policies, password expiration and auto-logout..................................................28
11.3 About periodical software updates and patches .........................................................................29
11.4 Dealing with a lost or stolen Corsano Bracelet............................................................................29
11.5 General Guidelines for Security..................................................................................................29
12 WARRANTY.......................................................................................................................30
13 SPECIFICATION..................................................................................................................31
14 ELECTRICAL SAFETY AND ELECTROMAGNETIC COMPATIBILITY ...........................................33
15 DISPOSAL OF THE DEVICE ..................................................................................................37

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16 LEGAL NOTICE FOR FCC AND ISED ......................................................................................38
17 CORSANO CONTACT INFORMATION ..................................................................................39

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1 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.
2 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 [e-mail] before
attempting to use this bracelet. For specific information about your own heartbeats,
consult with your physician.
2.1 Intended Use
The CardioWatch 287-2 is a wireless remote monitoring intended for continuous collection
of physiological data in home and healthcare settings. This includes heart rate, heart rate
variability (R-R interval), respiration rate, activity, sleep, ECG, SpO2, Body Temperature
and Blood Pressure. Data is transmitted wirelessly from the device via the application or
gateway to a server or health cloud where it is stored and made available for further
analysis.
The CardioWatch 287-2 is not intended for use in high-acuity environments, such as ICU
or operating rooms.
The CardioWatch 287-2 is not intended for use on acutely ill cardiac patients with the
potential to develop life threatening arrhythmias e.g. very fast atrial fibrillation. For these
patients, they should be monitored using a device with continuous ECG. The CardioWatch
287-2 System is not a substitute for an ECG monitor.
The CardioWatch 287-2 is not intended for SpO2 monitoring in conditions of high motion
or low perfusion.
2.2 Receiving and Inspection
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
suppo[email protected]
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.

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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. 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. This may result in incorrect operation of the bracelet and/or cause an
inaccurate reading.
DO NOT take recordings in close vicinity to strong electromagnetic fields (e.g.
electromagnetic anti-theft systems, metal detectors).
DO NOT use this bracelet in oxygen rich environments or near flammable gas.
The device is intended to be worn on the wrist (left or right), DO NOT use on other
parts of the body.
Consult with your physician before using this bracelet if you have common
arrhythmias such as atrial or ventricular premature beats or atrial fibrillation; arterial
sclerosis; poor perfusion; diabetes; pregnancy; pre-eclampsia or renal disease. NOTE
that any of these conditions in addition to patient motion, trembling, or shivering may
affect the measurement reading.
NEVER diagnose or treat yourself based on your readings. ALWAYS consult with
your physician.
To help avoid strangulation, keep the charger cable away from infants, toddlers or
children.
This product contains small parts that may cause a choking hazard if swallowed by
infants, toddlers or children.
The individual packaging contains important information, it should not be thrown
away.
2.3 Data Transmission
This product emits radio frequencies (RF) in the 2.4 GHz band. DO NOT use this product
in locations where RF is restricted, such as on an aircraft or in hospitals. Turn off the
Bluetooth® feature in this bracelet and remove batteries and/or unplug the charger when
in RF restricted areas. For further information on potential restrictions refer to
documentation on the Bluetooth usage by the FCC.

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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.
Consult with your 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 that no mobile device or any other electrical device
that emits electromagnetic fields is within 12 inches (30 cm) of this bracelet. This may
result in incorrect operation of the bracelet and/or cause an inaccurate reading.
DO NOT disassemble or attempt to repair this bracelet or other components. This
may cause an inaccurate reading.
DO NOT drop or subject this bracelet to strong shocks or vibrations.
DO NOT use this bracelet with other medical electrical (ME) equipment
simultaneously. This may result in incorrect operation of the bracelet and/or cause an
inaccurate reading.
Ensure that this bracelet has acclimated to room temperature before taking a
measurement. Taking a measurement after an extreme temperature change could
lead to an inaccurate reading.
Ensure the bracelet is well adjusted on the wrist to have the best performance of the
heart rate sensor, and not too tight to avoid skin injuries
2.5 Charger Handling and Usage
USE the charger cable with a CE marked adapter with the following characteristics:
oInput voltage: 100/240 V - 50hz 60hz
oOutput voltage: DC 5V (+-5%)
oMaximum current: 500 mA
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.
NEVER plug in or unplug the charger from the electric outlet with wet hands.

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DO NOT disassemble or attempt to repair the charger.
Fully insert the USB plug at the end of the charger into the USB outlet.
When unplugging the charger from the outlet, be sure to safely pull from the USB
outlet. DO NOT pull from the charger cable.
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.
Wipe any dust off of the charger.
Unplug the charger when not in use.
Unplug the charger before cleaning this bracelet.
2.6 Warnings
Regardless of the measurement taken using this device, you should immediately consult
your practitioner when you experience symptoms that could indicate a disease, such as
chest pain, pressure, tightness, etc.
You may be experiencing a cardiac arrhythmia or other disease even in the absence of a
notification from the APP. You should notify your practitioner at any changes of your
health condition.
If a serious incident occurs in relation to the device, it must be reported to the
manufacturer and the competent authority.
2.7 Residual risks
In rare cases, the device may detect arrhythmia while you experienced no cardiac
problems. You should contact your practitioner to get a diagnostics confirmation.
2.8 Clinical benefit
The CardioWatch 287 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.

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3 SYMBOLS
These instructions for use contain the following symbols (color and size may
vary):
Symbol
Meaning
1912
This stand-alone software is a medical device classified asrisk category
IIa, in accordance with rule 10 of EU Directive 93/42/EEC, last amended
by 2007/47/EC of the European Parliament and Council of 5 September
2007.
Indicates the medical 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.
Note
Indicates the need for the 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 manufacturer's serial number so that a specific medical device
can be identified
CE marking indicates that a product complies with applicable European
Union regulations
FCC marking indicates the electronic device, which sold in the United
States, is certified and the electromagnetic interference from the device is
under the limits that are approved by Federal Communications Commission
Indicates a product should not be disposed of in a landfill; the black bar
indicates that the equipment was manufactured after 2005
Refer to instruction manual/booklet.
The wearable device does not generate alarms.

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4 CONTENTS / PRODUCT INCLUDES
4.1 Receiving and Inspection
Remove this bracelet and other components from the packaging and inspect for damage.
If the bracelet or any other component is damaged, DO NOT USE and contact
suppo[email protected]
Read the Important Safety Information in this instruction manual before using this bracelet
and follow this instruction manual thoroughly for your own safety.
Keep the Instructions for Use for future reference.
CAUTION: The individual packaging contains important information, it should not be
thrown away.
4.2 Contents
One bracelet CardioWatch 287-2B:
Bracelet - CW287-2B
One USB charging cable:
Charger (CS-287CH-1)
One package box with instructions:
Instruction Manual (CS-287IFUEN-2)

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5 KNOW YOUR BRACELET
5.1 Back and Side of the bracelet
Back and Side view of Bracelet
(A) Green LED
(B) Orange LED
(C) Blue LED
5.2 Back and bottom of the bracelet
Back view of Bracelet
(D) Electrodes for ECG
(E) PPG Sensor
(F) Charge contacts
(G) Magnets for charge cable holding
WARNINGS
Stop using this bracelet and consult with your Physician or Healthcare Practician if
you experience skin irritation or discomfort.
To achieve the best performance of the heart rate sensor, ensure that the bracelet is
well adjusted on the wrist and not too tight so as to avoid skin irritation or injury.
Regardless of the measurement(s) taken or the values of the measurements made
using this device, you should immediately consult your Physician if you experience
symptoms that could indicate a disease, such as chest pain, chest pressure,
tightness, etc.

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You should notify your Physician or Healthcare Practitioner of any changes of your
health condition.
The device is intended to be worn on the wrist (left or right), DO NOT use on other
parts of the body.
DO NOT apply the wearable device on open wounds, sores, or cuts.
For specific information about your own heartbeats, CONSULT WITH YOUR
PHYSICIAN.
Ensure that this bracelet has acclimated to room temperature before taking a
measurement. Taking a measurement after an extreme temperature change may lead
to an inaccurate reading.
The bracelet is IP66 water resistant, which means it is protected against dust and
powerful water jets. Patients may shower with their bracelet.
Repair of the device may only be carried out by the manufacturer otherwise the
correct functioning of the device may be compromised.
No modification of the equipment is allowed. Modification of this equipment may cause
interference with other devices, injury to patient and user including electric shock,
burns or death.
DO NOT use this bracelet for any purpose other than the intended uses.
This product contains small parts that may cause a choking hazard if swallowed by
infants, toddlers, or children.
To help avoid strangulation, keep the charger cable away from infants, toddlers, or
children.
CAUTIONS
The device should not be placed over a tattoo - doing so may prevent calculation of an
accurate SpO2 or pulse rate.
DO NOT drop or subject this bracelet to strong shocks or vibrations.
5.3 Data Transmission
This product emits radio frequencies (RF) in the 2.4 GHz band. DO NOT use this product
in locations where RF is restricted. Turn off the Bluetooth® feature and/or unplug the
charger when in RF restricted areas. For further information on potential restrictions,
please refer to documentation on Bluetooth usage provided by the FCC.
CAUTION: 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.

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5.4 Charging the bracelet
Remove the device prior to charging.
Use the charger cable with a CE marked adapter with the following characteristics:
Input voltage: 100/240 V - 50hz 60hz
Output voltage: DC 5V (+-5%)
Maximum current: 500 mA
Plug the charger into the appropriate USB outlet.
Fully insert the USB plug at the end of the charger into the USB outlet.
Attach the charger cable to the backside of the bracelet. The magnets will pull the
charger head to the bracelet.
Charging view
The Magnets will click the charger into position. 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 the charger
contacts will align.
When unplugging the charger from the outlet, be sure to pull from the USB outlet safely
without pulling on the charger cable.
Keep the charger clean and wipe any dust off of the charger with a dry, soft cloth.
Unplug the charger when not in use.
Unplug the charger before cleaning the bracelet.
WARNINGS:
NEVER plug in or unplug the charger from the electric outlet with wet hands.
To avoid electrical shock, inspect all cables before use. Never use cables that appear
cracked, worn, or damaged in any way.
CAUTIONS:
Prevent liquid spillages onto the Charger. If the Charger is immersed in liquid, or has
liquid spilled on it, disconnect it and return it for service.
The battery charge level displayed in the user interface is only accurate if the batteries
are in normal working condition.

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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.
DO NOT disassemble or attempt to repair the charger.
DO NOT pull from the charger cable.
When handling the charger cable:
DO NOT damage, break, tamper with, forcibly bend, twist, or pull the charger cable.
DO NOT gathered the charger cable into a bundle or pinch it.
DO NOT place it under heavy objects.
5.5 LED Explanation
Bracelet side view
LED
Pattern
State
Green (A)
Flashing
Bracelet charging
Green (A)
ON
Bracelet fully charged (when on
charger)
Green (A)
OFF
Bracelet not on charger
Orange (B)
Flashing for 5 sec
Bracelet is initiating a Bluetooth Low
Energy connection
Orange (B)
ON for 5 seconds
Bracelet connected to a Smartphone
Blue (C)
ON
Bracelet is performing an ECG
measurement
LED Explanation
When the bracelet is close to the end of its battery autonomy, the Patient and Healthcare
Practitioner will receive a notification through the mobile APP (20%, 10% remaining). The
battery level is also displayed on the Web Portal, including low level alarm.

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5.6 Cleaning
The CardioWatch 287-2B Bracelet and USB Charge Cable are re-usable and may be
used for more than one patient. The strap is single use and should be disposed of in
clinical waste or according to local guidelines and regulations.
The re-usable components must be decontaminated following each and every episode of
use and prior to being sent for service or repair. This is to ensure the safety of both
patients and staff.
The term decontamination refers to a process that removes or destroys contamination.
Consequently, micro-organisms and other contaminants are prevented from reaching a
susceptible site in sufficient numbers to initiate infection or any harmful response.
Standard infection control precautions should be adhered to as per your local operating
institution’s guidelines, policies and procedures. It is the responsibility of the user to
ensure that correct decontamination has been carried out.
To clean the re-usable components they should be completely wiped with detergent
wipes, paying attention to all surfaces.
If there is evidence of blood or other bodily fluids, then disinfection wipes should be used.
Additional precautions should be taken, and personal protection equipment used, as per
your local operating institution guidelines, policies and procedures.
During usage, users should regularly check the condition of the CardioWatch 287-2B
Bracelet and USB Charge Cable and clean as necessary. Use a lint-free cloth moistened
with warm water to clean the housing and casing of your device. Use warm water and
hypoallergenic soap to clean the strap. Dry the wrist band with a soft cloth.
WARNING: Do not autoclave or sterilize the wearable device or any part of the
CardioWatch 287-2 monitoring system.

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6 USING YOUR BRACELET WITH THE CORSANO APP
6.1 Download and install the Corsano App onto your smart device.
6.2 First time use –Sign Up
Select “Sign Up” to create a user account (2)
Choose Sign-Up
Enter First Name, Last name, Email
Sign-Up
Agree on Terms of Service and Privacy
Policy
An email is sent to you with a 6-digit
code.

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Enter:
•Your password
•Your password again
•The received code
Press “Create account”
Create account
6.3 Sign In
Once you have created a user account, you
can sign-in in the APP.
Select “Sign In”(1)
Choose Sign-In

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Enter:
•Email
•Password
Press “Sign In”
Sign-In
6.4 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

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Connect the charger and press Start Pairing
Wait for the app to find the bracelet
Remove charging cable to complete pairing

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6.5 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. Force quit the app on your phone
5. Turn your phone’s Bluetooth off and on again
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 system in the phone
2. Turn your phone on again
3. Re-open the app
If none of the above did not resolve, you will need to re-pair your bracelet:
1. Go to watch settings: Remove/Clean old pairing
2. Go to Bluetooth settings, find 287-1B, 287-2B > Click Forget Device/Unpair
3. Force quit the app on your phone
4. Re-open the app
5. Press the (+) inside the watch icon in upper right corner
6. Follow pairing instructions

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6.6 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. Turn your 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). This will fully reset your phone
2. Turn your phone on again
3. Re-open the app
If none of the above did not resolve, you will need to to logout and login again to the
cloud:
1. Go to profile settings and log out
2. Force quit the app on your phone
3. Re-open the app
4. Enter user and password
5. Follow instructions