Corsano CardioWatch 287-1B User manual

As of 2022-07-27 Ι Revision status: 10
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EN
CardioWatch 287-1B
Bracelet & Corsano Trials App
Instruction Manual

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Table of Contents ..........................................................................................................................2
1INTRODUCTION ......................................................................................................................3
2SAFETY INSTRUCTIONS ...........................................................................................................3
2.1 Intended Use...............................................................................................................................3
2.2 Receiving and Inspection .............................................................................................................3
2.3 Data Transmission .......................................................................................................................4
2.4 Handling and Usage.....................................................................................................................5
2.5 Charger Handling and Usage ........................................................................................................5
2.6 Warnings.....................................................................................................................................6
2.7 Residual risks...............................................................................................................................6
2.8 Clinical benefit.............................................................................................................................6
2.9 Cleaning and service life...............................................................................................................6
3SYMBOLS................................................................................................................................8
4CONTENTS / PRODUCT INCLUDES............................................................................................9
5KNOW YOUR BRACELET ........................................................................................................10
5.1 Front of the bracelet..................................................................................................................10
5.2 Back and bottom of the bracelet ................................................................................................10
5.3 Charging the bracelet.................................................................................................................11
6USING YOUR BRACELET WITH A SMART DEVICE ....................................................................13
6.1 Download and install the free “Corsano Trials” app onto your smart device................................13
6.2 First time use.............................................................................................................................13
6.3 Pairing Your Bracelet with a Smart Device ..................................................................................18
6.4 Troubleshooting the Bluetooth Connection ................................................................................21
6.5 Troubleshooting the Cloud Connection.......................................................................................22
7RECORD PATIENTS ................................................................................................................23
8NON-MEDICAL INFORMATION ..............................................................................................25
9HEALTH APP AND GOOGLE FIT INTEGRATION........................................................................28
10 CLINICAL PERFORMANCE...................................................................................................29
11 CYBERSECURITY.................................................................................................................30
11.1 Information Security Management System.................................................................................30
11.2 About password policies, password expiration and auto-logout..................................................30
11.3 About periodical software updates and patches .........................................................................31
11.4 Dealing with a lost or stolen Corsano Bracelet ............................................................................31
11.5 General Guidelines for Security..................................................................................................31
12 WARRANTY.......................................................................................................................32
13 SPECIFICATION..................................................................................................................33
14 ELECTRICAL SAFETY AND ELECTROMAGNETIC COMPATIBILITY ...........................................34
15 DISPOSAL OF THE DEVICE ..................................................................................................38
16 CORSANO CONTACT INFORMATION ..................................................................................39

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1 INTRODUCTION
Thank you for purchasing the Corsano CardioWatch 287-1B. The CardioWatch bracelet
records raw PPG and ACC data, which is transferred to the application and cloud.
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 287-1B 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
This device is a digital bracelet intended for use in measuring pulse rate and activity in
adult patient population.
Environments of Use: Hospital and Home Patient Population: Adult
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.
•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

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

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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.
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 287-1B 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.
2.9 Cleaning and service life
Use a lint-free cloth moistened with warm water to clean the housing and casing of your
device.

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Use warm water and hypoallergenic soap to clean the strap.
Dry the wrist band with a soft cloth.
It is not necessary to sterilize the device.
The Smartwatch is an electronic device with rechargeable battery. The expected service
life is 5 years.

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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

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4 CONTENTS / PRODUCT INCLUDES
Figure 1 -Bracelet (CS-287-1B)
Figure 2 - Charger (CS-287CH-1)
Figure 3 - Instruction Manual (CS-287IFUEN-1)

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5 KNOW YOUR BRACELET
5.1 Front of the bracelet
(A) Ambient Temperature Sensor
(B) LEDs
(C) Pusher button
Figure 4 –Front view of Bracelet
5.2 Back and bottom of the bracelet
(D) Temperature Sensors
(E) PPG Sensor
(F) Magnets
(G) Charge Contacts
Figure 5 –Back view of Bracelet