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1 | User Manual | Users Manual | 1.94 MiB | March 15 2022 |
Polso Watch Instructions for Use REVISION 01 February 2021 page 0 of 47 ChroniSense Medical LTD. 2 Hamada St. Yokneam Illit 2069202 Israel Tel: +972-4-8275095 support@polsowatch.com 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
. page 1 of 47 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 page 2 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 3 of 47 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 page 4 of 47 2 3 4 5 1 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 PolsoTM 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 The Wrist Holder positions the sensor modules. ECG leads PPG arrays 6 Wrist Strap keeps the PolsoTM Watch securely and comfortably on the patients wrist. 7 Finger ECG sensor activates the PolsoTM Watch physiological monitoring. Home Screen Display 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. Shows status of Bluetooth connection to the PolsoTM App. Hours and minutes of local time. May be in 24-hour or 12-hour mode. Day, month, and year. 1 Charge indicators Bluetooth indicator Time indication Date indication 2 3 4 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. page 5 of 47 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. 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 Note Bluetooth. Home screen page 6 of 47 Parameter name The parameter of interest. Indicates the charge status of the PolsoTM Watch battery. 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. The icon the PolsoTM App associates with the parameter. Displays measurements by parameter
(NOT in real-time). This indicates the date& time of the last measurement of this parameter Pressing this advances to the history screen for this parameter. Returns the user to the PolsoTM App home screen. 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. Battery status Bluetooth (BT) connection status& button Parameter Icon Value& units Time stamp Navigation arrow Home button Blood Pressure initialization button Settings button Opens the settings menu. page 7 of 47 Package contents PolsoTM Watch with Wrist Strap:
1 SMALL/MEDIUM/LARGE PolsoTM Watch Charger Stand Micro USB cable Power Supply 1 1 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 Support@polsowatch.com. page 8 of 47 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 arent 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. page 9 of 47 Patients with severe anemia. Patients with any known allergy to plastic, metals, and/or rubber. Warnings physician. 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 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 isnt 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. page 10 of 47 DO NOT disassemble or attempt to repair any part of the PolsoTM Watch, PolsoTM Charger Stand, or power supply. Cautions measurements. use. damaged. 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 The PolsoTM Watch should be used only for the purpose described in the indications for Do not use the PolsoTM Watch if the package has been opened, or appears used, or 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 support@polsowatch.com. readings. Misapplication of the PolsoTM Watch with excessive pressure can result in inaccurate Misspositioniong of the PolsoTM Watch can result in inaccurate readings. page 11 of 47 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. immediately and inform your HCP. If skin irritation or damage appears with use of the PolsoTM Watch, stop using it 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 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 ChroniSense customer support at support@polsowatch.com Watch. page 12 of 47 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. page 13 of 47 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 and benefits. Before using any medical device, it is important to consult your physician and weigh the risks 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. hazards. As with all devices with small parts, there is always a risk of a childs swallowing a component or choking. Keep small parts away from small children to prevent such 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 patients skin contacts the sensor to prevent potential issues. page 14 of 47 Getting Started Take the PolsoTM Watch out of the box and fully charge it. Charging the PolsoTM Watch indication is presented. and a wall charger. 1 To charge, connect the large end of the micro USB cable to the power adapter. The PolsoTM Watch requires periodic charging. Charge between uses, or when a low battery The PolsoTM Watch Charger Stand is used for charging the watch, along with a micro USB cable 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 15 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 16 of 47 Turn on the PolsoTM Watch Press and hold the Control Button to turn the PolsoTM Watch on. 2 A QR code identifying the PolsoTM Watch appears. 1 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 17 of 47 Wearing the PolsoTM Watch Which wrist is best?
The PolsoWatch can be worn on either the left or right wrist, according to your preference. Nevertheless, once set up is completed, the PolsoWatch 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. PolsoTM Watch size markings 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. page 18 of 47 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. page 19 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 20 of 47 Taking a Measurement respiration rate. The PolsoTM Watch is designed for spot checks of blood pressure, pulse rate, SpO2, and Before taking a measurement make sure that the PolsoTM 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 PolsoTM Watch measurement. 1. Place your hand with the PolsoTM Watch on a table or desk, near chest level. 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, and short red poor quality. 3 If you have selected the option to display partial settings (see chapter 7 Settings), the PolsoTM Watch display will cycle between available results and the measurement screen. Incomplete measurements will be represented by a dotted line. page 21 of 47 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. 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 22 of 47 8 After a successful measurement, the PolsoTM Watch 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 23 of 47 Blood Pressure Initialization To ensure accurate blood pressure readings, the PolsoTM 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 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 message may be ignored, but the message will replace any subsequent blood pressure measurement. page 24 of 47 1 Blood Pressure initialization Press the blood pressure initialization button on the PolsoTM 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. 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 arterial circulation. Waiting one minute allows enough time for your circulation to reset. page 25 of 47 5 For accurate initialization, make sure you sit quietly, so that blood pressure is stable. Take a PolsoTM Watch measurement within the next 5 minutes for initialization to be valid. 6 Taking a Polso Watch Measurement You should sit comfortably, not talk, and avoid movement while taking a PolsoTM Watch measurement. 1. Place your hand with the PolsoTM Watch on a table or desk, near chest level. 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. 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 short red poor quality. 8 End of Blood Pressure initialization 1. When the results screen appears on the PolsoTM Watch, the patient can remove their thumb. 2. Two short vibrations confirm the end of measurement. page 26 of 47 9 A message will appear on the PolsoTM App to confirm successful blood pressure re-
initialization. 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 27 of 47 History With history, you can review up to the last 3 months of data recorded and saved in the PolsoTM 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. 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 conventional Android dragging. page 28 of 47 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 29 of 47 Within settings, previously entered personal information and system settings can be edited. Further options are available on these screens. Settings User Settings Note from your HCP. System settings Note 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. You cannot change the wrist used without assistance Changes to the user interface can be made here. Setting up a new watch should only be done by your HCP. Incorrect setup can lead to inaccurate results. page 30 of 47 About App version number. Displays the PolsoTM Watch serial number and the PolsoTM Polso Watch placement wizard button Starts the Watch placement wizard. Turning Off Your PolsoTM Watch Shutting down the PolsoTM 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 perform the transffer. page 31 of 47 Error list and Troubleshooting Error list (PolsoTM Watch) Display Cause Solution The PolsoTM Watch battery is extremely low. Charge the PolsoTM Watch. Refer to sub-section 3.1 The PolsoTM Watch cannot connect to an Android device
(Bluetooth icon is missing). 1. Press the Control Button to make sure the PolsoTM Watch display is on. 2. Press the Bluetooth connection status & button in the PolsoTM App to scan for the PolsoTM Watch. 3. Make sure Bluetooth is enabled on the Android device 4. If not successful, restart the Android device 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. Thumb makes poor contact with Finger ECG sensor. Consult with your HCP about verifying sizing. 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 ECG sensor. Movement affects measurement Re-do measurement being sure to remain still and not speak Measurement stopped by user. 1. Try again. 2. Make sure that the thumb fully covers the Finger ECG sensor, and apply slightly increased pressure. Make sure there is no moisture or residue on the Finger ECG sensor. page 32 of 47 Display Cause Solution Blood pressure initialization 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 33 of 47 Troubleshooting Problem Cause Solution Nothing appears on the display of the PolsoTM Watch. The operating time is short even when the battery is fully charged. The PolsoTM Watch is off. Turn the PolsoTM Watch on. Battery has completely depleted. Charge the PolsoTM Watch, see chapter 3.1 . Rechargeable battery is near end of life. Contact customer service at service@polsowatch.com Measurement doesnt start The PolsoTM Watch is not optimally positioned. Thumb makes poor contact with Finger ECG sensor. PolsoTM Watch malfunction. Reposition the PolsoTM Watch according to instructions in this guide. Make sure that the thumb fully covers the Finger ECG sensor, and apply slightly increased pressure. Make sure there is no moisture or residue on the Finger ECG sensor. Contact customer service at service@polsowatch.com 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 ECG sensor. Movement affects the measurement. Re-do measurement being sure to remain still and not speak. Unsuccessful measurement The PolsoTM Watch is not optimally positioned. No blood pressure results are displayed. Blood pressure initialization timed out. Perform blood pressure initialization, see chapter 5. Incomplete measurement Try again. The signal quality issue in one or more parameters. Bluetooth isnt active on the PolsoTM Watch. No Bluetooth connection when using the PolsoTM App. Press the control button on the PolsoTM Watch to activate Bluetooth. Press the red Bluetooth connection status button to connect to the PolsoTM Watch. The Bluetooth connection status button will turn green when communication is established. page 34 of 47 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 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 35 of 47 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. Slide the knob to the left using a fingernail, and lift the right side of the wrist strap up. page 36 of 47 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 37 of 47 Cleaning and Disinfecting the PolsoTM Watch To clean the PolsoTM 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. Repeat the above cleaning step using a fresh wipe. Allow the PolsoTM Watch to dry thoroughly before using it again. 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 Warning Disposal 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. page 38 of 47 Specifications Model Physiological data measured Pulse Oximetry (SpO2) PolsoTM Watch 1865501 PolsoTM Watch Charger Stand 1865502 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 25 240 bpm Respiration 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 Lithium-ion polymer researchable battery
(3.7 V/330mAh) AC adapter
(INPUT AC100-240 V, 50-60 Hz 0.2-0.13 A) At least 500 charge cycles. Under normal use, taking up to 12 readings per day, a full charge should last 24 hours. USB charging Charging time: 3.5 hours Android Version 5 or higher Bluetooth 4.2 AMOLED page 39 of 47 Power& Battery Battery lifespan Charging Compatibility Communication Display History Capacity IP classification 3 months PolsoTM Watch IP22 PolsoTM Watch Charger Stand IP21 Operating Conditions 32104F (040C) Temperature Storage & Transport conditions
-4140F (-20 60C) Temperature Up to 90% relative maximum humidity, non-
condensing 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 (40C) 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 useful to clinicians. page 40 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 page 41 of 47 FCC Radio frequency interference statement 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. 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 radio or communication interference caused by using other than specified or recommended cables and battery or by unauthorized changes or modifications to this equipment. Changes or modifications not expressly approved by the manufacturer could void the users authority to operate the equipment. 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. page 42 of 47 Bluetooth LE Wireless Technology Information Bluetooth 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 43 of 47 Limited Warranty ChroniSense Medical Ltd. warrants to the original end-user purchaser the ChroniSense Medical-branded hardware product the PolsoTM Watch and any software media contained in the original packaging against defects in material and workmanship when used in accordance with ChroniSense Medicals Instruction for Use and other ChroniSense Medical materials published guidelines for a period of 24 months from the original date the Product was obtained by the end-user purchaser. ChroniSense Medicals 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 request a replacement under warranty, purchaser must 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 provided to Purchaser under applicable laws and regulations of the region in which the product was sold to the extent that those rights cannot be disclaimed and are superseded by the above described warranty to the extent permitted under applicable laws and regulations of the region in which the product was For service-related issues with your PolsoTM Watch, contact us at support@polsowatch.com. sold. Customer service ChroniSense Medical LTD. 2 Hamada St. Yokneam Illit 2069202 Israel Tel: +972-4-8275095 support@polsowatch.com www.polsowatch.com page 44 of 47 General Symbols Consult Instructions for Use Prescription-only device Manufacturer Date of manufacture YYYY-MM Catalog 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 45 of 47 IP22 IP21 Protection from ingress No Parameters Alarms Warning Caution Note page 46 of 47 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 systems condition. of blood and pulse rate. user. Pulse Oximeter: A medical device that uses a sensor to indirectly measure oxygen saturation Quality of Service (QoS): Description or measurement of overall performance of the Bluetooth communication between the PolsoTM Watch and the PolsoTM App as seen by the page 47 of 47
1 | FCC Short & Long Term Confidentiality Request Rev4.1 | Cover Letter(s) | 126.04 KiB | March 15 2022 |
Office of Engineering Technology Federal Communication Commission 7435 Oakland Mills Road Columbia, MD 21046 Subject: Request for confidentiality FCC ID: 2A32P-PWK0999000002 To Whom it may concern. Date: Jan 16, 2022 Pursuant to the provisions of Sections 0.457 and 0.459 of Commissions rules (47 CFR 0.457, 0.459), we are requesting the Commission to withhold the following attachments as confidential document from public disclosure indefinitely. Theory of Operation/Technical Description Block Diagram Schematics Parts List (BOM) Above mentioned documents contain detailed system and equipment description and considered as proprietary information in operation of the equipment. The public disclosure of above documents might be harmful to our company and would give competitor an unfair advantage in the market. In additional to above mentioned documents, pursuant to Public Notice DA 04-1705 of the Commissions policy, in order to comply withy marketing regulations in 47CFT 2.803 and the important rules in 47 CFR 2.1204, while ensuring that business sensitive information remains confidential until the actual marketing of newly authorized devices, we are requesting the Commission to grant short-term confidentiality request on the following attachments for 180 days after the grant is outlined in Public Notice DA 04-1705:
It is our understanding that all measurement test reports, FCC ID label format and correspondent during certification review process cannot be granted as confidential documents and that information will be available for public review once the grant of equipment authorization is issued. Users Manual External Photos Internal Photos Sincerely, _ ___________ Name: Vladimir Gomon Title: Hardware engineer ____________________________________________________________________________________ Hacarmel 2 | P.O.B 684 | Yokneam Illit | Israel | 2069202
1 | Letter of Authorization | Cover Letter(s) | 151.24 KiB | March 15 2022 |
Letter of Authorization Company:
Address:
Product Name:
Model Number:
FCC Identifier:
ChroniSense Medical ltd. P.O.B. 399, 2, HaCarmel str. Yokneam Illit Israel Polso WatchTM 099-900-0002 2A32P-PWK0999000002 We authorize MiCOM Labs Inc, 575 Boulder Court, Pleasanton, California 94566, USA, to act on our behalf on all matters concerning the above named equipment. Any individual within MiCOM Labs is authorized to act on our behalf and take action on the application. We declare that MiCOM Labs Inc, 575 Boulder Court, Pleasanton, California 94566, USA, is allowed to forward all information related to the approval project to the Federal Communication Commission and to discuss any issues concerning the approval application. Any and all acts carried out by MiCOM Labs on our behalf shall have the same effect as acts of our own. Name: Vladimir Gomon Title: Hardware Engineer Signature of applicant:
Date: 16.01.2022 ____________________________________________________________________________________ Hacarmel 2 | P.O.B 684 | Yokneam Illit | Israel | 2069202
frequency | equipment class | purpose | ||
---|---|---|---|---|
1 | 2022-03-15 | 2402 ~ 2480 | DTS - Digital Transmission System | Original Equipment |
app s | Applicant Information | |||||
---|---|---|---|---|---|---|
1 | Effective |
2022-03-15
|
||||
1 | Applicant's complete, legal business name |
ChroniSense Medical Ltd.
|
||||
1 | FCC Registration Number (FRN) |
0031757636
|
||||
1 | Physical Address |
HaCarmel 2 building Alon, entrance A
|
||||
1 |
HaCarmel 2
|
|||||
1 |
399
|
|||||
1 |
Yokneam Illit, N/A
|
|||||
1 |
Israel
|
|||||
app s | TCB Information | |||||
1 | TCB Application Email Address |
c******@micomlabs.com
|
||||
1 | TCB Scope |
A4: UNII devices & low power transmitters using spread spectrum techniques
|
||||
app s | FCC ID | |||||
1 | Grantee Code |
2A32P
|
||||
1 | Equipment Product Code |
PWK0999000002
|
||||
app s | Person at the applicant's address to receive grant or for contact | |||||
1 | Name |
V******** G******
|
||||
1 | Telephone Number |
+9725********
|
||||
1 | Fax Number |
+972 ********
|
||||
1 |
v******@chronisense.com
|
|||||
app s | Technical Contact | |||||
1 | Firm Name |
ChroniSense Medical Ltd.
|
||||
1 | Physical Address |
Israel
|
||||
app s | Non Technical Contact | |||||
n/a | ||||||
app s | Confidentiality (long or short term) | |||||
1 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | No | ||||
if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
1 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 | Equipment Class | DTS - Digital Transmission System | ||||
1 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | Polso Watch | ||||
1 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 | Modular Equipment Type | Does not apply | ||||
1 | Purpose / Application is for | Original Equipment | ||||
1 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | No | ||||
1 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | No | ||||
1 | Grant Comments | Output power listed is conducted power. | ||||
1 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
app s | Test Firm Name and Contact Information | |||||
1 | Firm Name |
Electrical and Electronics Laboratory, SII
|
||||
1 | Name |
Y**** R****
|
||||
1 | Telephone Number |
972-3********
|
||||
1 | Fax Number |
972-3********
|
||||
1 |
Y******@sii.org.il
|
|||||
Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15C | 2402.00000000 | 2480.00000000 | 0.0034670 |
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC