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ChroniSense Medical Polso 1865501, Instructions For Use Manual

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ChroniSense Medical Polso 1865501 Instructions For Use Manual Download Page 42

 

 

page 41 of 47 

 

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 

•

 

IEC 60601-1-6:2010, AMD1:2013 for use in conjunction with IEC 62366:2007, 

AMD1:2014 and IEC 60601-1:2005, COR1:2006, COR2:2007, AMD1: 2012 or 

equivalent consolidated version IEC 60601-1:2012 (Edition 3.1) 

•

 

IEC 60601-1-11 MEDICAL ELECTRICAL EQUIPMENT 

–

 Part 1-11: General requirements 

for basic safety and essential performance 

–

 Collateral Standard: Requirements for 

medical electrical equipment and medical electrical systems used in the home 

healthcare environment 

•

 

ISO 80601-2-61: 2017 Medical electrical equipment -- Part 2-61: Particular 

requirements for basic safety and essential performance of pulse oximeter equipment 

•

 

IEC 62304:2006/A1:2016 Medical Device Software - Software Life Cycle Processes 

 

 

 

 

 

 

 

 

 

 

 

 

Summary of Contents for Polso 1865501

Page 1: ...page 0 of 47 Polso Watch Instructions for Use REVISION 01 February 2021 ...

Page 2: ...tant 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 ...

Page 3: ...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 ...

Page 4: ...page 3 of 47 Applicable standards 41 FCC Radio frequency interference statement 42 Bluetooth LE Wireless Technology Information 43 Limited Warranty 44 General Symbols 45 Glossary 47 ...

Page 5: ...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...

Page 6: ...ent 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...

Page 7: ...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 di...

Page 8: ...M 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 initializati...

Page 9: ... 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 Support polsowatch com ...

Page 10: ...malities 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 trig...

Page 11: ...ation 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 restrict...

Page 12: ...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...

Page 13: ...tentially 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 de...

Page 14: ... 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 ...

Page 15: ...M 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 childr...

Page 16: ...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 ...

Page 17: ...page 16 of 47 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 ...

Page 18: ...ol 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 ...

Page 19: ...and 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 to...

Page 20: ...l 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 Wat...

Page 21: ...of 47 4 Tighten and close the watch strap while keeping the sensor at that position on the wrist The PolsoTM Watch should feel comfortable on the wrist The Polso Watch should be as close as possible to the hand ...

Page 22: ...el 2 Initiate measurement by placing and continuously holding your thumb on the ECG Finger Sensor as shown 3 The PolsoTM Watch will then emit 1 vibration notification to confirm measurement initiation 2 The PolsoTM Watch display will show the measurement screen with an ongoing PPG signal and a status message A long green bar indicates high signal quality medium yellow indicates moderate quality an...

Page 23: ...ters press the control button to cycle through them 6 If any measurement fails a dashed line will be displayed instead of a result 7 Measurement Problem 1 An error message appears if all measurements fail 2 This will be accompanied by 1 long vibration 3 Another measurement can be attempted possibly after repositioning the PolsoTM Watch on the wrist See chapter 8 2 Troubleshooting ...

Page 24: ...tch will transmit the results to the PolsoTM 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: ...lert will appear on both the PolsoTM App and the PolsoTM Watch when the initialization must be performed It is also possible to re initialize the PolsoTM Watch before the 30 day period has ended PolsoTM Watch initialization alert On the PolsoTM Watch the initialization message may be ignored but any measurements will not show blood pressure PolsoTM App initialization alert On the PolsoTM App the m...

Page 26: ...he number of days should be 0 Press START to continue 3 Perform an accurate blood pressure reading from the same arm that the PolsoTM Watch is worn and record it in the PolsoTM App data field Press SAVE to continue Note Make sure the same arm as the PolsoTM Watch is worn is used for all reference initialization measurements 4 Using a blood pressure cuff changes some characteristics of your arteria...

Page 27: ... Initiate measurement by placing and continuously holding your thumb on the ECG Finger Sensor as shown 3 The PolsoTM Watch will then emit 1 vibration notification to confirm measurement initiation 7 The PolsoTM Watch display will show the measurement screen with an ongoing PPG signal and a status message A long green bar indicates high signal quality medium yellow indicates moderate quality and sh...

Page 28: ...tion Press OK to continue 10 After a successful measurement the PolsoTM Watch will transmit the results to the PolsoTM App where they will appear on the screen 11 Blood Pressure initialization failure If the PolsoTM Watch is incorrectly placed a message appears on the PolsoTM App screen Press OK to continue ...

Page 29: ...r mode displays historical data in table format Graphic mode displays historical data using a line graph Access the history from the home screen by pressing the Navigation arrow on the right of each parameter When you press the navigation arrow history opens in Tabular mode Here your blood pressure history is displayed The results are sorted by date and time Scrolling through them is done by using...

Page 30: ...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: ...an 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 Note You cannot change the wrist used without assistance from your HCP System settings Changes to the user interface can be made here Note Setting up a new watch should only be done by your HCP Incorrect setup can lead to inaccurat...

Page 32: ...olsoTM Watch is done by holding the Control Button continuously until the shutdown screen appears The screen will display the shutdown message for about 3 seconds while shutdown is in progress Transferring to a new Android device You can use a new Android device without losing your current data For reasons of information security you will not be able to do this on your own Contact yout HCP to perf...

Page 33: ...e and or the PolsoTM Watch The PolsoTM Watch is not optimally positioned Reposition the PolsoTM Watch according to instructions in this guide The PolsoTM Watch is not optimally sized Consult with your HCP about verifying sizing Thumb makes poor contact with Finger ECG sensor Make sure that your thumb fully covers the Finger ECG sensor and apply slightly increased pressure Make sure there is no moi...

Page 34: ...itialization timed out Perform blood pressure initialization See chapter 5 The PolsoTM Watch isn t on the same hand used during setup 1 Verify the correct wrist in the User Settings 2 Remove the PolsoTM Watch and place it on the correct hand and try again ...

Page 35: ...olsoTM Watch is not optimally positioned Reposition the PolsoTM Watch according to instructions in this guide The PolsoTM Watch is not optimally sized Consult with your HCP about verifying sizing Thumb makes poor contact with Finger ECG sensor Make sure that your thumb fully covers the Finger ECG sensor and apply slightly increased pressure Make sure there is no moisture or residue on the Finger E...

Page 36: ...e PolsoTM Watch uses a quick release system to make the process of replacing the wrist strap easy 1 Hold the PolsoTM Watch with the buckle upward looking at the back of the PolsoTM Watch 2 To remove the buckle part of the wrist strap find the small knob at the left where the wrist strap meets the watch case Slide the knob to the right using a fingernail and lift the left side of the wrist strap up...

Page 37: ...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 Slide the knob to the left using a fingernail and lift the right side of the wrist strap up ...

Page 38: ...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: ...as of the device Repeat the above cleaning step using a fresh wipe Allow the PolsoTM Watch to dry thoroughly before using it again Warning Before cleaning make sure the device is off and is not applied to a wrist Improper cleaning of the PolsoTM Watch may damage it Do not wash or immerse your PolsoTM Watch in water Disposal Dispose of the PolsoTM Watch in accordance with federal state and local la...

Page 40: ...ration Rate No Motion Measurement range 5 45 bpm Accuracy 1 bpm Display range 5 45 bpm Blood Pressure No Motion Measurement range Sys Dia Accuracy Display range Power Battery Lithium ion polymer researchable battery 3 7 V 330mAh AC adapter INPUT AC100 240 V 50 60 Hz 0 2 0 13 A Battery lifespan At least 500 charge cycles Charging Under normal use taking up to 12 readings per day a full charge shoul...

Page 41: ...Transport conditions 4 140 F 20 60 C Temperature Up to 90 relative maximum humidity non condensing Weight 1 76 oz 50 gr Measurable wrist circumference 5 5 8 4 inch 14 21 4 cm Applied part CF Maximum temperature of the applied part 104 F 40 C The emitted wavelengths range from 600 nm to 1000 nm and the peak optical power is less than 15 mW Information about the wavelength range can be especially us...

Page 42: ...n with IEC 62366 2007 AMD1 2014 and IEC 60601 1 2005 COR1 2006 COR2 2007 AMD1 2012 or equivalent consolidated version IEC 60601 1 2012 Edition 3 1 IEC 60601 1 11 MEDICAL ELECTRICAL EQUIPMENT Part 1 11 General requirements for basic safety and essential performance Collateral Standard Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environmen...

Page 43: ...o 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 Connect the equipment into an outlet on a circuit different from that to which the receiver is connected Consult the dealer or an experienced radio TV technician for help ChroniSense Medical Ltd is not responsible for any r...

Page 44: ...h LE Wireless Technology Information Modulation Type DSSS CCK OFDM Max Output 19dBm Frequency Range 2402 MHz 2480 MHz Antenna Peak Gain 2 5dBi Recommended Range 10 feet 3 meters line of sight Quality of Service QoS Delay 10 seconds Security Proprietary binary protocol ...

Page 45: ... contact ChroniSense Medical Ltd and obtain a returned goods authorization number so that ChroniSense Medical Ltd can track the Product If ChroniSense Medical Ltd determines that a Product must be replaced under warranty it will be replaced and the cost of shipment covered All other shipping costs must be paid by purchaser The above described warranty is in addition to any statutory rights provide...

Page 46: ...talog number Serial number FCC ID Identifies unit has been registered as a radio device Type CF applied part Separate collection for electrical and electronic equipment WEEE symbol Keep dry Fragile handle with care Storage humidity limitation Atmospheric pressure limitation Storage temperature range Wireless communication mark ...

Page 47: ...page 46 of 47 IP22 IP21 Protection from ingress No Parameters Alarms Warning Caution Note ...

Page 48: ... 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 Pulse Oximeter A medical device that uses a sensor to indirectly measure oxygen saturation of blood and pulse rate Quality of Service QoS Description or measurement of overall performance of the Bluetooth communication between the PolsoTM Watch and the PolsoTM...

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