Corsano CardioWatch 287 User manual

!
!
2020-10-08
!
!
"!
!!
EN
CardioWatch 287
Bracelet Instruction Manual

!
!
2020-10-08
!
!
#!
!!
1 Table of Contents
2 INTRODUCTION ....................................................................................................................... 3
3 SAFETY INSTRUCTIONS ............................................................................................................ 3
3.1 Intended Use ................................................................................................................................. 3
3.2 Receiving and Inspection ............................................................................................................... 3
3.3 Data Transmission ......................................................................................................................... 4
3.4 Charger Handling and Usage .......................................................................................................... 4
3.5 Handling and Usage ....................................................................................................................... 5
3.6 Charger Handling and Usage .......................................................................................................... 5
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 & install the “CORSANO PREVENTICUS SMART IN OAC” app onto your smart device. . 12
7.2 First time use ............................................................................................................................... 12
7.3 Register for participation in the Smart in OAC – AFNET 9 study .................................................... 15
7.4 Pairing Your Bracelet with a Smart Device ................................................................................... 26
7.5 Troubleshooting the Bluetooth Connection ................................................................................. 28
7.6 Troubleshooting the Cloud Connection ........................................................................................ 29
7.7 Smart in OAC – AFNET 9 status screen ......................................................................................... 30
7.8 End of Screening Period ............................................................................................................... 31
7.9 Activity screen ............................................................................................................................. 32
8 SPECIFICATION ...................................................................................................................... 33
9 ELECTRICAL SAFETY AND ELECTROMAGNETIC COMPATIBILITY ............................................... 34
10 DISPOSAL OF THE DEVICE ................................................................................................... 37
11 CORSANO CONTACT INFORMATION ................................................................................... 38
!
! !

!
!
2020-10-08
!
!
$!
!!
2 INTRODUCTION
Thank you for purchasing the 287 CardioWatch. Corsano CardioWatch not only analyses
your heartbeat, but also and especially your 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 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 [phone] 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.
!"# $%&'%('()*+')
)
This device is a digital bracelet intended for use in measuring pulse rate and activity in
adult patient population. The device provides the data for further cardiovascular,
respiratory, and sleep analysis in order to provide a warning signal in case of the
appearance of irregular heartbeats during measurement.
Environments of Use: Hospital and Home Patient Population: Adult
!", -'.'/0/%1)2%()$%+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
!
!
%!
!!
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.
!"! 52&2)672%+8/++/4%)
)
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.
!"9 :;271'7)<2%(=/%1)2%()*+21')

!
!
2020-10-08
!
!
&!
!!
)
• 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.
!"> <2%(=/%1)2%()*+21')
)
• 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.
!"? :;271'7)<2%(=/%1)2%()*+21')
)
• 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.

!
!
2020-10-08
!
!
'!
!!
• 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.

!
!
2020-10-08
!
!
(!
!!
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.
Note
Indicates the need for the user to consult the instructions for use
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

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

!
!
2020-10-08
!
!
*!
!!
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
!
!
"+!
!!
?"! :;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
!
!
""!
!!
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

!
!
2020-10-08
!
!
"#!
!!
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
• Android: version 8.0 or higher
Please check latest list: Compatible_smartphone_characteristics
E", @/7+&)&/8')S+')
The first time you open the app the screen below will appear. Please tap on “Register” to
start the enrolment for the Smart in OAC – AFNET 9 study.

!
!
2020-10-08
!
!
"$!
!!
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 –
AFNET 9 study logo.
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 consecutive characters.
!

!
!
2020-10-08
!
!
"%!
!!
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
!
!
"&!
!!
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
!
!
"'!
!!
Afterwards, please enter your year of birth, your sex, and your ethnic background
(optional).

!
!
2020-10-08
!
!
"(!
!!
Please answer several health-related questions (blood-thinning medication, atrial
fibrillation, hypertension, etc.) on the following screens. You can tap on i for further
information (e.g. a list of blood-thinning medication).
!

!
!
2020-10-08
!
!
")!
!!
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. You can further rate your current overall health status
on a scale between 0 and 100. Therefore, please adjust the slider. If you would like to
change any of your answers, you may do so by pressing the "Previous" button prior to
finalizing the questionnaire. Please finalize the questionnaire by pressing the ”Finalize"
button.
!

!
!
2020-10-08
!
!
"*!
!!
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. Please select by tapping the appropriate button.
!

!
!
2020-10-08
!
!
#+!
!!
You will receive a summary of your entries. Please check and tap on “Confirm” to go on.
!