Corsano CardioWatch 287-1 User manual

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CardioWatch 287-1
Bracelet & Corsano Trials
Instruction Manual

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1 Table of Contents
2 INTRODUCTION ........................................................................................................................ 3
3 SAFETY INSTRUCTIONS ............................................................................................................. 3
3.1 Intended Use .................................................................................................................................. 3
3.2 Receiving and Inspection ................................................................................................................ 4
3.3 Data Transmission .......................................................................................................................... 4
3.4 Charger Handling and Usage ........................................................................................................... 5
3.5 Handling and Usage ........................................................................................................................ 5
3.6 Charger Handling and Usage ........................................................................................................... 6
4 SYMBOLS .................................................................................................................................. 7
5 CONTENTS / PRODUCT INCLUDES ............................................................................................. 8
6 KNOW YOUR BRACELET ............................................................................................................ 9
6.1 Front of the bracelet ...................................................................................................................... 9
6.2 Back and bottom of the bracelet .................................................................................................... 9
6.3 Charging the bracelet ................................................................................................................... 10
7 USING YOUR BRACELET WITH A SMART DEVICE ...................................................................... 12
7.1 Download and install the free “CORSANO” app onto your smart device. ...................................... 12
7.2 First time use ...................................................................................... Error! Bookmark not defined.
7.3 Pairing Your Bracelet with a Smart Device ........................................... Error! Bookmark not defined.
7.4 Troubleshooting the Bluetooth Connection .................................................................................. 16
7.5 Troubleshooting the Cloud Connection ........................................................................................ 17
8 NON-MEDICAL INFORMATION ....................................................... Error! Bookmark not defined.
9 PREMIUM SERVICE ........................................................................ Error! Bookmark not defined.
10 PREVENTICUS HEARTBEATS ........................................................ Error! Bookmark not defined.
10.1 Purpose ............................................................................................... Error! Bookmark not defined.
10.2 Intended use ....................................................................................... Error! Bookmark not defined.
10.3 Additional notes and comments .......................................................... Error! Bookmark not defined.
10.4 Service life of the product ................................................................... Error! Bookmark not defined.
10.5 Data backup ........................................................................................ Error! Bookmark not defined.
10.6 Measuring principle: basics of the pulse curve analysis ....................... Error! Bookmark not defined.
10.7 Reading and accepting the purpose, including warnings, Terms and Conditions and Privacy Policy
Error! Bookmark not defined.
10.8 Interpretation of the results ................................................................ Error! Bookmark not defined.
10.9 Overview of the measurement report ................................................. Error! Bookmark not defined.
10.10 Measurement reportlist .................................................................. Error! Bookmark not defined.
10.11 Telecare reportlist ........................................................................... Error! Bookmark not defined.
10.12 Telecare order report ...................................................................... Error! Bookmark not defined.
11 HEALTH APP AND GOOGLE FIT INTEGRATION ............................. Error! Bookmark not defined.
12 SPECIFICATION .................................................................................................................... 24
13 ELECTRICAL SAFETY AND ELECTROMAGNETIC COMPATIBILITY ............................................ 25
14 DISPOSAL OF THE DEVICE .................................................................................................... 28
15 CORSANO CONTACT INFORMATION .................................................................................... 29
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2 INTRODUCTION
Thank you for purchasing the 287 CardioWatch. Corsano CardioWatch not only analyses
heartbeat, but also and especially heart rhythm - simple and at any time. The bracelet has
been validated in clinical studies and detects 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 or your patient 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 287
CardioWatch 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.
Although clinical studies have shown that the bracelet in combination with a suitable heart
rhythm interpretation service is able to identify arrhythmias (such as atrial fibrillation) with
a very high accuracy level the slight possibility of a miscalculation still exists. Therefore,
the results provided should under no circumstances replace the personal diagnosis,
consultation, care or treatment by medical or medically trained staff.
In case any serious incident has occurred in relation to the device it has to be reported to
the manufacturer and the competent authority of the Member State in which the user
and/or patient is established.
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This device is a digital bracelet intended for use in measuring pulse rate and activity in
adult patient population. The device provides the data for further cardiovascular,
respiratory, and sleep analysis in order to provide a warning signal in case of the
appearance of irregular heartbeats during measurement.
Environments of Use: Hospital and Home Patient Population: Adult

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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 +31-
12345678.
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.
• 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 use this bracelet in oxygen rich environments or near flammable gas.
• 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.
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This product emits radio frequencies (RF) in the 2.4 GHz band. DO NOT use this product

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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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• 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.
• DO NOT disassemble or attempt to repair the charger.
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• 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.

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• 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.

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4 SYMBOLS
These instructions for use contain the following symbols (color and size may
vary):
Symbol
Meaning
Indicates the investigative 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
Indicates the manufacturer's catalogue number so the device can
be identified
Indicates the manufacturer's serial number so that a specific 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

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

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6 KNOW YOUR BRACELET
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(A) Ambient Temperature Sensor
(B) LEDs
(C) Pusher button
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(D) Temperature Sensors
(E) PPG Sensor
(F) Magnets
(G) Charge Contacts

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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.

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The polarity of the magnets in the bracelet and the charger will ensure that the charger
contacts will align.
LED
Pattern
State
Green (B1)
Flashing
Bracelet charging
Green (B1)
OFF
Bracelet fully charged
or not on charger

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7 USING YOUR BRACELET WITH A SMART DEVICE
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The “CORSANO TRIALS” app is currently available only via AppTester. You need to
inform the email address to which we should send the invitation. Minimum requirements
for use of the app, currently available for Android only:
• Android: version 8.0 or higher
Please check latest list: Compatible_smartphone_characteristics
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When you first open the app, you will be asked to set the name of your bracelet.
Click on the picker:
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Identify your bracelet’s name on its strap, and select it in the menu:
Click on the button “SAVE”:
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Press the pusher on the bracelet. The orange LED will flash: the bracelet is waiting for
pairing.
Click on the upper right hand corner icon:
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Click on the name of your device:
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Enter the password 999999 and click on “OK”:
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When your bracelet is connected successfully to your smart device, the green “V” symbol
appears on the screen:
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If the connection between the bracelet and app is lost, a red “X” will appear:
Click on the button Please Reconnect Bracelet and follow instructions:
1. Make sure your phone is nearby
2. Check if watch is charged
3. Check if GPS is on (Android only)
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, 286, 284 > 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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If the connection between the app and the cloud is lost, a red “X” will appear:
Click on the button Please Reconnect To Cloud and 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
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Click on the upper right hand corner logo:
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If the app indicates that a software update is available, click on it:
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Click on “Start”:!
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During the update, keep your bracelet close to your phone. The update will take
approximately one minute. When the update is done, click on “Done”.