ChroniSense Medical Polso 1865501 Instructions For Use Manual

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Polso™ Watch

Instructions for Use

REVISION 01

February 2021

page 0 of 47

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Page 1 Polso™ Watch Instructions for Use REVISION 01 February 2021 page 0 of 47...
Page 2 It is important to read the Instruction for Use in its entirety prior to using the Poslo 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.
Page 3: Table Of Contents
Contents System Overview..........................4 Polso Watch Overview ......................4 Home Screen Display ...................... 5 Polso Application Overview ....................6 Home screen ........................6 Package contents ........................8 Receiving and Inspection ....................8 General Considerations ........................9 Indications for Use ........................9 Contraindications ........................
Page 4 Applicable standards ........................41 FCC Radio frequency interference statement ................42 Bluetooth LE Wireless Technology Information ................43 Limited Warranty .......................... 44 General Symbols ........................... 45 Glossary ............................47 page 3 of 47...
Page 5: System Overview
System Overview The Polso Watch is a wearable device for non-invasive measurement and display of pulse rate, SpO2 (blood oxygen saturation), respiration rate, and blood pressure. The Polso Watch is worn on the wrist, with specialized sensors that are located at the radial artery, for measurement of physiological information.
Page 6: Home Screen Display
User information is visible on the (AMOLED) Display User interaction is through the Control Button There are two modes for use of the Button: • Press and hold - only used for turning the Polso Watch on and off • Short press - less than 2 seconds. Used for: o Toggling between screens o Release from standby mode o Clear message on screen...
Page 7: Polso Tm Application Overview
Polso Application Overview The Polso Watch monitors and displays SpO , pulse rate, respiration rate and blood pressure. It stores these data, and transmits them via Bluetooth to the Polso App on an Android device. The Polso App allows examination of these data, including up to 3 months of readings stored previously.
Page 8 Indicates the charge status of the Polso Battery status Watch battery. Indicates whether the Polso Watch and Android device are connected by BT. A green checkmark indicates a working Bluetooth (BT) connection connection. A red dot indicates no status& button connection.
Page 9: Package Contents
Package contents Polso Watch with Wrist Strap: SMALL/MEDIUM/LARGE Polso Watch Charger Stand Micro USB cable Power Supply Polso Watch Instructions for Use This guide Receiving and Inspection Note: Open only with the assistance of your HCP. Remove the Polso Watch from the packaging and inspect for damage. Remove the protective layer before using the Polso Watch.
Page 10: General Considerations
General Considerations Indications for Use The Polso 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 Polso 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.
Page 11: Warnings
• Patients with severe anemia. • Patients with any known allergy to plastic, metals, and/or rubber. Warnings • The Polso 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.
Page 12: Cautions
• DO NOT disassemble or attempt to repair any part of the Polso Watch, Polso Charger Stand, or power supply. Cautions • DO NOT operate the Polso Watch without appropriate training by a certified HCP. • DO NOT use the Polso Watch together with lotion or moisturizer.
Page 13 • Dispose of the Polso 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 Polso Watch, stop using it immediately and inform your HCP.
Page 14: Data Safety
Data Safety • Use only the official Polso 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 Polso 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.
Page 15: Risks And Benefits
• 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.
Page 16: Getting Started
Getting Started Take the Polso Watch out of the box and fully charge it. Charging the Polso Watch The Polso Watch requires periodic charging. Charge between uses, or when a low battery indication is presented. The Polso Watch Charger Stand is used for charging the watch, along with a micro USB cable and a wall charger.
Page 17 4 Place the Polso Watch on the Polso Watch Charger Stand platform in either orientation. 5 The Polso Watch will display the battery charging status. page 16 of 47...
Page 18: Turn On The Polso Tm Watch
Turn on the Polso Watch Press and hold the Control Button to turn the Polso Watch on. A QR code identifying the Polso 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 Polso Watch.
Page 19: Wearing The Polso Tm Watch
Wearing the Polso 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 Polso watch to the new position.
Page 20 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.
Page 21 4 Tighten and close the watch strap, while keeping the sensor at that position on the wrist. The Polso Watch should feel comfortable on the wrist. The Polso™ Watch should be as close as possible to the hand. page 20 of 47...
Page 22: Taking A Measurement
Taking a Measurement The Polso Watch is designed for spot checks of blood pressure, pulse rate, SpO respiration rate. Before taking a measurement make sure that the Polso Watch is correctly positioned. Measurements should be taken while sitting still and not talking. 1 You should sit comfortably, not talk, and avoid movement while taking a Polso Watch measurement.
Page 23 4 End of Measurement 1. When the results screen appears, you can remove your thumb. 2. Two short vibrations confirm the end of measurement. 5 To focus on individual parameters, press the control button to cycle through them. 6 If any measurement fails, a dashed line will be displayed instead of a result.
Page 24 8 After a successful measurement, the Polso Watch will transmit the results to the Polso App, where they will appear on the screen. The timestamp circled in yellow, indicates the date and time of the last reading for that parameter. If no new data were acquired, the date and time will be for an earlier reading.
Page 25: Blood Pressure Initialization
Blood Pressure Initialization To ensure accurate blood pressure readings, the Polso Watch must periodically be re- initialized against a reference blood pressure monitor. This monitor should be used for all subsequent initializations. You should re-initialize every 30 days. An alert will appear on both the Polso App and the Polso Watch when the initialization must be performed.
Page 26 Blood Pressure initialization Press the blood pressure initialization button on the Polso App. 2 The first screen of the blood pressure initialization displays the number of days before blood pressure initialization must be performed. If the alert was displayed the number of days should be 0.
Page 27 5 For accurate initialization, make sure you sit quietly, so that blood pressure is stable. Take a Polso Watch measurement within the next 5 minutes for initialization to be valid. Taking a Polso Watch Measurement You should sit comfortably, not talk, and avoid movement while taking a Polso Watch measurement.
Page 28 9 A message will appear on the Polso to confirm successful blood pressure re- initialization. Press OK to continue. 10 After a successful measurement, the Polso Watch will transmit the results to the Polso App, where they will appear on the screen.
Page 29: History
History With history, you can review up to the last 3 months of data recorded and saved in the Polso application. History is displayed by individual parameter. There are two display options for historical data: Tabular mode - displays historical data in table format. Graphic mode - displays historical data using a line graph.
Page 30 Pressing the graph mode button will open the graphic mode. Results can be displayed by DAY, WEEK, or MONTH by pressing the appropriate button. Tapping on the dot indicating a reading will present all the data measured. Switching between tabular and graphic mode is done by pressing the buttons.
Page 31: Settings
Settings Within settings, previously entered personal information and system settings can be edited. Further options are available on these screens. User Settings • Changes to your personal details can be made here. • Some changes will require blood pressure initialization. Weight change A weight change (gain or loss) of 20% or more requires a change in the weight setting...
Page 32: Turning Off Your Polso Tm Watch
About Displays the Polso Watch serial number and the Polso App version number. Polso Watch placement wizard button Starts the Watch placement wizard. Turning Off Your Polso Watch Shutting down the Polso Watch is done by holding the Control Button continuously until the shutdown screen appears.
Page 33: Error List And Troubleshooting
Error list and Troubleshooting Error list (Polso Watch) Display Cause Solution The Polso Watch Charge the Polso Watch. battery is extremely Refer to sub-section 3.1 low. The Polso Watch 1. Press the Control Button to cannot connect to an make sure the Polso Watch Android device display is on.
Page 34 Display Cause Solution Blood pressure Perform blood pressure initialization timed initialization See chapter 5. out. The Polso Watch 1. Verify the correct wrist in the isn't on the same hand User Settings. used during setup. 2. Remove the Polso Watch and place it on the correct hand and try again.
Page 35: Troubleshooting
Troubleshooting Problem Cause Solution Nothing appears on The Polso Watch is off. Turn the Polso Watch on. the display of the Battery has completely Charge the Polso Watch, see Polso Watch. depleted. chapter 3.1 . The operating time is short Rechargeable battery is Contact customer service at even when the battery is...
Page 36: Maintenance
Maintenance Replacing the wrist strap Under normal use, there is no need to replace the wrist strap. However, should you desire to replace the wrist strap follow the instructions below. The Polso Watch uses a quick release system to make the process of replacing the wrist strap easy.
Page 37 3 Release the knob and pull the wrist strap from the right side of the case. Set the buckle part of the wrist strap aside. 4 To remove the lower part of the wrist strap, find the small knob at the right where the wrist strap meets the watch case.
Page 38 5 Release the knob and pull the wrist strap from the left side of the case. Set the lower part of the wrist strap aside. 6 To attach the replacement wrist strap, reverse this process. Make sure that the buckle part of the wrist strap is at the top.
Page 39: Cleaning And Disinfecting The Polso Tm Watch
Cleaning and Disinfecting the Polso Watch To clean the Polso Watch, follow the instructions below: • Wipe the outer surfaces using a dampened soft cloth twice with 70% Alcohol until the surfaces are free of any visible residue. Pay particular attention to cracks, crevices, and hard to reach areas of the device.
Page 40: Specifications
Specifications Model Polso Watch 1865501 Polso Watch Charger Stand 1865502 Physiological data measured Pulse Oximetry (SpO No Motion Measurement range 70 - 100% Accuracy ±3.5% within 70 - 100% range Display range 70 - 100% Pulse Rate No Motion Measurement range 25 – 240 bpm Accuracy ±3 bpm of reading Display range 25 –...
Page 41 History Capacity 3 months IP classification Polso Watch IP22 Polso Watch Charger Stand IP21 Operating Conditions 32÷104°F (0÷40°C) Temperature Up to 90% relative maximum humidity, non- condensing Storage & Transport conditions -4÷140°F (-20 ÷ 60°C) Temperature Up to 90% relative maximum humidity, non- condensing Weight 1.76 oz (50 gr)
Page 42: Applicable Standards
Applicable standards • IEC 60601-1:2005+AMD1:2012 CSV Consolidated version Medical electrical equipment - Part 1: General requirements for basic safety and essential performance • IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests •...
Page 43: Fcc Radio Frequency Interference Statement
• Consult the dealer or an experienced radio/TV technician for help. ChroniSense Medical Ltd. is not responsible for any radio or communication interference caused by using other than specified or recommended cables and battery or by unauthorized changes or modifications to this equipment.
Page 44: Bluetooth Le Wireless Technology Information
Bluetooth LE Wireless Technology Information Bluetooth LE Wireless Technology Information Modulation Type DSSS / CCK/ OFDM Max. Output 19dBm Frequency Range 2402 MHz - 2480 MHz 2.5dBi Antenna Peak Gain Recommended Range ~10 feet (~3 meters) line-of-sight Quality of Service (QoS) Delay <10 seconds Security Proprietary binary protocol...
Page 45: Limited Warranty
24 months from the original date the Product was obtained by the end-user purchaser. ChroniSense Medical’s sole obligation under this warranty is the repair or replacement, at its option, of any defective Product or software media that is covered under the warranty. To...
Page 46: General Symbols
General Symbols Consult Instructions for Use Prescription-only device Manufacturer Date of manufacture YYYY-MM Catalog number Serial number Identifies unit has been registered FCC ID as a radio device Type CF applied part Separate collection for electrical and electronic equipment (WEEE symbol) Keep dry Fragile;...
Page 47 IP22 Protection from ingress IP21 No Parameters Alarms Warning Caution Note page 46 of 47...
Page 48: Glossary
Glossary Hemoglobin : The protein in red blood cells that transports oxygen from the lungs throughout the body and carbon dioxide from the tissues back to the lungs. Oxygen Saturation : The percentage of hemoglobin in the blood that is bound to oxygen. Parameter : A parameter is an element of a system that is critical in evaluating the system’s condition.

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Polso 1865502