ChroniSense Medical Polso 1865501 User manual
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Polso™ Watch
Instructions for Use
REVISION 01
February 2021
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ChroniSense Medical LTD.
2 Hamada St.
Yokneam Illit 2069202
Israel
Tel: +972-4-8275095
www.polsowatch.com
It is important to read the Instruction for Use in its entirety prior to using the
PosloTM Watch
Copyright ©2015-2020 ChroniSense Medical, Ltd. All rights reserved.
Confidential and Proprietary
Investigational device use only, not for sale in the USA
This product is protected by the following:
US patent no. 10470692
US patent no. 10687742
and other pending US patents
.
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Contents
System Overview.............................................................................................................................4
PolsoTM Watch Overview.........................................................................................................4
Home Screen Display ......................................................................................................5
PolsoTM Application Overview.................................................................................................6
Home screen ...................................................................................................................6
Package contents ....................................................................................................................8
Receiving and Inspection ................................................................................................8
General Considerations...................................................................................................................9
Indications for Use..................................................................................................................9
Contraindications....................................................................................................................9
Warnings...............................................................................................................................10
Cautions ...............................................................................................................................11
Data Safety....................................................................................................................13
Notes.....................................................................................................................................13
Risks and Benefits .................................................................................................................14
Potential Risks Associated with the PolsoTM Watch......................................................14
Getting Started..............................................................................................................................15
Charging the PolsoTM Watch .................................................................................................15
Turn on the PolsoTM Watch...................................................................................................17
Wearing the PolsoTM Watch..................................................................................................18
Which wrist is best? ......................................................................................................18
Placing the PolsoTM Watch on the wrist........................................................................18
Taking a Measurement .................................................................................................................21
Blood Pressure Initialization .........................................................................................................24
History...........................................................................................................................................28
Settings..........................................................................................................................................30
Turning Off Your PolsoTM Watch ...........................................................................................31
Transferring to a new Android device ..........................................................................................31
Error list and Troubleshooting ......................................................................................................32
Error list (PolsoTM Watch)......................................................................................................32
Troubleshooting....................................................................................................................34
Maintenance.................................................................................................................................35
Replacing the wrist strap ......................................................................................................35
Cleaning and Disinfecting the PolsoTM Watch.......................................................................38
Disposal.................................................................................................................................38
Specifications ................................................................................................................................39
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Applicable standards.....................................................................................................................41
FCC Radio frequency interference statement ..............................................................................42
Bluetooth LE Wireless Technology Information ...........................................................................43
Limited Warranty..........................................................................................................................44
General Symbols ...........................................................................................................................45
Glossary.........................................................................................................................................47
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System Overview
The PolsoTM Watch is a wearable device for non-invasive measurement and display of pulse
rate, SpO2 (blood oxygen saturation), respiration rate, and blood pressure. The PolsoTM Watch
is worn on the wrist, with specialized sensors that are located at the radial artery, for
measurement of physiological information. The PolsoTM Watch screen displays measurements,
battery status, and time of day. The User Interface Control Button (Figure 1a, 2) allows
navigation between different display screens.
The Wrist Holder (Figure 1a, 3), is intended to secure a precise positioning of the PolsoTM Watch
on your wrist. The form factor of the sensors is positioned and spaced with the intention of
offering easy placement over the radial artery. The watch is available in sizes S, M and L to
cover wrist sizes from 6.5” to 9” diameter.
A control-button control provides device control. Vibratory feedback is also provided with
dedicated hardware. An Android application furnishes further system functionality for display
of current and prior results. A rechargeable lithium-polymer battery powers the PolsoTM Watch
and will be charged using a proprietary PolsoTM Watch Charger.
To maintain accuracy, the PolsoTM Watch requires re-initialization of blood pressure every 30
days. This involves performing a blood pressure measurement with a standard cuff device. Your
HCP should make sure that you have a suitable device.
PolsoTM Watch Overview
Figure 1a
Figure 1b
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1
User information is visible on the (AMOLED) Display
2
User interaction is through the Control Button
There are two modes for use of the Button:
•Press and hold - only used for turning the PolsoTM Watch on and off
•Short press - less than 2 seconds. Used for:
oToggling between screens
oRelease from standby mode
oClear message on screen
3
The Wrist Holder positions the sensor modules.
4
ECG leads
5
PPG arrays
6
Wrist Strap keeps the PolsoTM Watch securely and comfortably on the patient’s wrist.
7
Finger ECG sensor activates the PolsoTM Watch physiological monitoring.
Home Screen Display
1
Charge indicators
Shows amount of remaining charge in percent next to the battery
icon, which also changes as the battery discharges.
Note
When the battery is critically low, at 15%, the percentage power
number will turn red.
2
Bluetooth indicator
Shows status of Bluetooth connection to the PolsoTM App.
3
Time indication
Hours and minutes of local time. May be in 24-hour or 12-hour
mode.
4
Date indication
Day, month, and year.
Note
After a short period of inactivity, the Polso Watch display will enter sleep mode to conserve
power. A short press of the control button will reactivate the display.
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PolsoTM Application Overview
The PolsoTM Watch monitors and displays SpO2, pulse rate, respiration rate and blood pressure.
It stores these data, and transmits them via Bluetooth to the PolsoTM App on an Android device.
The PolsoTM App allows examination of these data, including up to 3 months of readings stored
previously. It is also used for setting up the PolsoTM Watch, and for initializing and entering
descriptive patient data. Download The PolsoTM App prior to watch setup and use.
Navigation through the PolsoTM App is assisted by the native Android keys.
Note
The power-saving feature of the PolsoTM Watch turns Bluetooth off when not in use for an
extended period. Before using the PolsoTM App, turn the PolsoTM Watch display on by pressing
the control button. The PolsoTM App will then automatically connect to the PolsoTM Watch via
Bluetooth.
Home screen
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Battery status
Indicates the charge status of the PolsoTM
Watch battery.
Bluetooth (BT) connection
status& button
Indicates whether the PolsoTM Watch and
Android device are connected by BT. A
green checkmark indicates a working
connection. A red dot indicates no
connection.
Pressing the button will initiate a BT
connection.
Parameter name
The parameter of interest.
Parameter Icon
The icon the PolsoTM App associates with
the parameter.
Value& units
Displays measurements by parameter
(NOT in real-time).
Time stamp
This indicates the date& time of the last
measurement of this parameter
Navigation arrow
Pressing this advances to the history
screen for this parameter.
Home button
Returns the user to the PolsoTM App
home screen.
Blood Pressure
initialization button
Launches the Blood Pressure,
initialization wizard.
Note: When blood pressure
initialization has expired, an alert will
appear in the blood pressure section
reminding you to initialize and the icon
will turn red.
Settings button
Opens the settings menu.
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Package contents
PolsoTM Watch with Wrist Strap:
SMALL/MEDIUM/LARGE
1
PolsoTM Watch Charger Stand
1
Micro USB cable
1
Power Supply
1
PolsoTM Watch Instructions for Use
1
This guide
Receiving and Inspection
Note: Open only with the assistance of your HCP.
Remove the PolsoTM Watch from the packaging and inspect for damage. Remove the
protective layer before using the PolsoTM Watch.
If the PolsoTM Watch or other components are damaged, DO NOT USE and contact
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General Considerations
Indications for Use
The PolsoTM Watch is a wrist-worn device indicated for use in measuring and displaying
functional oxygen saturation of arterial hemoglobin (%SpO2), pulse rate, and respiration rate.
The PolsoTM Watch can track blood pressure changes based on Pulse Arrival Time (PAT). PAT is
obtained utilizing pulse rate measurements from the integrated PPG (SpO2) sensor and ECG
electrodes, following an initiation process using an oscillometric blood pressure monitor.
The PolsoTM Watch is a prescription use device intended for spot-checking measurements of
patients aged 18 years and older in the home use environment.
Contraindications
The PolsoTM Watch is not intended for use by:
•Pregnant patients.
•Patients with deformities or abnormalities that may prevent proper application of the
Polso™ Watch. These include but aren’t limited to significant swelling or irritation,
injuries, localized infection, ulceration or skin lesions, scarification, tattoos, and body
art on the wrist.
•Patients with sustained or non-sustained ventricular/atrial arrhythmia (Ventricular
tachycardia, supraventricular tachycardia, atrial fibrillation, bigeminy, and trigeminy),
and left bundle branch block.
•Patients with implantable defibrillators, pacemakers, neurostimulators, or other
implantable or worn devices which may interfere with the Polso™ Watch, or be affected
by the Polso™ Watch in normal operation and use.
•Patients with Parkinson's disease, essential tremor, convulsive disorders, or other
disorder which prevents them from keeping their forearm at rest.
•Patients with compromised circulation or peripheral vascular disease.
•Patients with elevated levels of Methemoglobin (MetHb) or Carboxyhemoglobin
(COHb), or with anomalous hemoglobins.
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•Patients with severe anemia.
•Patients with any known allergy to plastic, metals, and/or rubber.
Warnings
•The PolsoTM Watch is intended only as an adjunct in patient assessment.
•DO NOT diagnose or treat yourself based on your readings, instead, consult with your
physician.
•DO NOT adjust medication or alter any instructions from your physician based on
readings from the PolsoTM Watch.
•The PolsoTM Watch should not be used in conjunction with these medical assist
devices:Intra-Aortic Balloon Pump (IABP), Left Ventricular Assist Device (LVAD), and
cardio-pulmonary bypass systems.
•The PolsoTM Watch should not be used in conjunction with systems which generate high
radiation or magnetic fields, which may disrupt PolsoTM Watch sensors and/or other
hardware. These include, but are not limited to, irradiation systems, X-ray, MRI, CT,
electrosurgery systems, and extreme lights such as strobes.
•DO NOT use the PolsoTM Watch on a wrist under medical treatment. This includes but
isn’t limited to a cast, brace, or wrap-bandage.
•DO NOT use the PolsoTM Watch on wrists that have restricted blood flow e.g.
tourniquet, pressure cuff, or IV line.
•The PolsoTM Watch contains small parts, so to avoid choking hazard keep away from
children.
•The PolsoTM Watch should not be used during patient exercise or motion.
•The PolsoTM Watch should not be used by patients treated with injected dyes, or any
substance containing dyes, that change usual blood pigmentation.
•No SpO2, pulse rate, respiration rate, or blood pressure alarms are provided.
•DO NOT use the power supply when wet.
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•DO NOT disassemble or attempt to repair any part of the PolsoTM Watch, PolsoTM
Charger Stand, or power supply.
Cautions
•DO NOT operate the PolsoTM Watch without appropriate training by a certified HCP.
•DO NOT use the PolsoTM Watch together with lotion or moisturizer. PolsoTM Watch can
be used only after lotion or moisturizer has been removed by washing.
•Remove any jewelry or accessories from your wrist wearing the PolsoTM Watch while
taking a measurement.
•The PolsoTM Watch can only measure while the patient is at rest.
•Make sure the PolsoTM Watch is used on the same wrist for all reference initialization
measurements.
•The PolsoTM Watch should be used only for the purpose described in the indications for
use.
•Do not use the PolsoTM Watch if the package has been opened, or appears used, or
damaged.
•Incorrect handling, excessive force, or dropping the PolsoTM Watch may cause
malfunction or permanent damage.
•Do not re-manufacture, recondition or recycle PolsoTM Watch to prevent harm or
damage to the device.
•DO NOT subject the PolsoTM Watch to strong shocks or vibrations.
•DO NOT immerse the PolsoTM Watch in water or any other liquid.
•If the PolsoTM Watch fails to operate, contact ChroniSense customer support at
•Misapplication of the PolsoTM Watch with excessive pressure can result in inaccurate
readings.
•Misspositioniong of the PolsoTM Watch can result in inaccurate readings.
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•Dispose of the PolsoTM Watch in accordance with federal, state, and local law for
routine/non-hazardous electronic waste. This product should not be mixed with
general household waste.
•If skin irritation or damage appears with use of the PolsoTM Watch, stop using it
immediately and inform your HCP.
•DO NOT let chemical products such as oils, lotions, creams, or cosmetics accumulate
on the PolsoTM Watch. Wipe and clean with 70% alcohol immediately if this happens.
•DO NOT attempt to sterilize the PolsoTM Watch. DO NOT autoclave, or immerse the
PolsoTM Watch in liquid.
•If the temperature or humidity is outside of the recommended range (see chapter 10
Specifications), do not use the PolsoTM Watch.
•DO NOT use the PolsoTM Watch in a potentially explosive atmosphere, such as in the
presence of flammable chemicals.
•DO NOT use the PolsoTM Watch if sensors have become degraded, for example,
discolored, peeling, or pitted. Such use may result in PolsoTM Watch malfunction.
•DO NOT leave the PolsoTM Watch within the reach of infants, toddlers, children, or pets,
who may damage the PolsoTM Watch.
•DO NOT use the USB cable and power supply with any device other than the PolsoTM
Watch.
•Use only the power supply and USB cable specified for the PolsoTM Watch. Use of other
power supplies or cables may damage and/or may be hazardous to the PolsoTM Watch.
•DO NOT touch, press, or rub the display panels with anything that could scratch the
display, such as abrasive cleaning compounds, instruments, brushes, or rough-surface
materials. These can damage the device.
•If you suspect problems in accuracy or performance of the PolsoTM Watch, contact
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Data Safety
•Use only the official PolsoTM App downloaded from Google Play.
•Follow Android OS permission recommendations.
•Observe basic Android device safety precautions, including locking the Android device
and not leaving it unattended.
Notes
•When using the PolsoTM Watch with a device with wireless features, consideration
should be taken to local government frequency allocations and technical parameters
to minimize the possibility of interference to/from other wireless devices.
•In accordance with international telecommunication requirements, the frequency
band of 2.4 GHz is only for indoor usage to reduce potential for harmful interference
to co-channel mobile satellite systems.
•This device complies with Part 15 of the FCC Rules. Operation is subject to the following
two conditions: (1) This device may not cause harmful interference, and (2) this device
must accept any interference received, including interference that may cause
undesired operation.
•This equipment has been tested and found to comply with the limits for a Class B digital
device, pursuant to part 15 of the FCC Rules. These limits are designed to provide
reasonable protection against harmful interference in a residential installation. This
equipment generates, uses, and can radiate radio frequency energy and, if not installed
and used in accordance with the instructions, may cause harmful interference to radio
communications. However, there is no guarantee that interference will not occur in a
particular installation. If this equipment does cause harmful interference to radio or
television reception, which can be determined by turning the equipment off and on,
the user is encouraged to try to correct the interference by one or more of the following
measures:
•Reorient or relocate the receiving antenna.
•Increase the separation between the equipment and receiver.
•Consult the dealer or an experienced radio/TV technician for help.
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•This equipment has been tested and found to comply with the Class B limits for medical
devices according to the IEC 60601-1-2:2014. These limits are designed to provide
reasonable protection against harmful interference in all establishments, including
domestic establishments.
Risks and Benefits
Before using any medical device, it is important to consult your physician and weigh the risks
and benefits.
The following section describes the Benefits and Risks associated with using the PolsoTM Watch.
Potential Risks Associated with the PolsoTM Watch
•As with all medical electrical devices, there is always a risk of electrical, mechanical, and
fire hazards. However, these risks have been mitigated through the design and testing
of the PolsoTM Watch.
•As with all devices with small parts, there is always a risk of a child’s swallowing a
component or choking. Keep small parts away from small children to prevent such
hazards.
•As with all items applied directly to the skin, there is always a risk of skin irritation,
pressure injury, and general discomfort while a sensor or cuff is applied to a patient.
Periodically check the areas where the patient’s skin contacts the sensor to prevent
potential issues.
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Getting Started
Take the PolsoTM Watch out of the box and fully charge it.
Charging the PolsoTM Watch
The PolsoTM Watch requires periodic charging. Charge between uses, or when a low battery
indication is presented.
The PolsoTM Watch Charger Stand is used for charging the watch, along with a micro USB cable
and a wall charger.
1
To charge, connect the large end of the micro
USB cable to the power adapter.
2
Connect the small end of the micro USB cable to
the PolsoTM Watch Charger Stand.
3
Plug the power adapter into the electrical power
supply socket.
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4
Place the PolsoTM Watch on the PolsoTM Watch
Charger Stand platform in either orientation.
5
The PolsoTM Watch will display the battery
charging status.
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Turn on the PolsoTM Watch
1
Press and hold the Control Button to turn the
PolsoTM Watch on.
2
A QR code identifying the PolsoTM Watch
appears.
Note
You should not turn the Polso Watch off until you have completed setup. Instructions for
turning the Polso Watch off may be found in chapter 7.1 Turning Off Your PolsoTM Watch.
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Wearing the PolsoTM Watch
Which wrist is best?
The Polso™Watch can be worn on either the left or right wrist, according to your preference.
Nevertheless, once set up is completed, the Polso™Watch must always be worn on the same
wrist to assure optimal performance.
If however, you will decide to change the watch position to the other hand, notify your HCP,
who will reset the PolsoTM watch to the new position.
Placing the PolsoTM Watch on the wrist
The Polso™ Watch is available in 3 different sizes based on your wrist circumference. Your
HCP will select the proper size for you.
Apply the Polso™ Watch on clean, dry skin. The correct positioning for the Polso™ Watch is
when the back of it is placed on top of the radial artery while it is touching the skin but not
making pressure marks. An illustration for placing the watch on the left wrist is given below.
PolsoTM Watch size markings
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1
You should straighten your left hand, and place
your right-hand index and middle fingers at the
inner left wrist, against the base of the left thumb.
The two fingertips should be in between the bone
and the tendon over the radial artery, in sort of a
valley.
Find the pulse point. The radial artery pulse can
be felt beneath the right index and middle
fingertips. Moving those fingers slightly may help
to locate the strongest pulse.
If you are unfamiliar with taking pulse, you should
consult with your HCP.
2
The gap between both fingertips creates an
imaginary triangle. Imagine a short horizontal line
on the triangle base. This line will serve as a pulse
point mark for placing the Polso™ Watch.
3
Place the upper edge of the sensor head (white)
against the pulse point mark, as shown by the
arrow.
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