The Polso™ Watch is a wrist-worn medical device designed for non-invasive measurement and display of several physiological parameters, including pulse rate, SpO2 (blood oxygen saturation), respiration rate, and blood pressure. It stores these data and transmits them via Bluetooth to the Polso™ App on an Android device, which allows for the examination of up to three months of stored readings. The app is also used for setting up the Polso™ Watch, initializing blood pressure measurements, and entering descriptive patient data.
Function Description:
The Polso™ Watch monitors and displays SpO2, pulse rate, respiration rate, and blood pressure. Blood pressure tracking is based on Pulse Arrival Time (PAT), obtained using pulse rate measurements from the integrated PPG (SpO2) sensor and ECG electrodes, following an initialization process with an oscillometric blood pressure monitor. It is a prescription-use device intended for spot-checking measurements in patients aged 18 years and older in a home-use environment.
Important Technical Specifications:
- Model: Polso™ Watch 1865501, Polso™ Watch Charger Stand 1865502
- Physiological Data Measured:
- Pulse Oximetry (SpO2):
- Measurement range: 70 - 100%
- Accuracy: ±3.5% within 70 - 100% range
- Display range: 70 - 100%
- Pulse Rate:
- Measurement range: 25 – 240 bpm
- Accuracy: ±3 bpm of reading
- Display range: 25 – 240 bpm
- Respiration Rate:
- Measurement range: 5-45 bpm
- Accuracy: 1 bpm
- Display range: 5-45 bpm
- Blood Pressure: No specific measurement range or accuracy provided, but it tracks changes based on PAT.
- Power & Battery:
- Lithium-ion polymer rechargeable 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
- Full charge duration: 24 hours (up to 12 readings per day)
- Charging time: 3.5 hours
- Compatibility: Android Version 5 or higher
- Communication: Bluetooth 4.2 (DSSS/CCK/OFDM, 19dBm Max. Output, 2402 MHz - 2480 MHz Frequency Range, 2.5dBi Antenna Peak Gain, ~10 feet (~3 meters) line-of-sight Recommended Range, Delay <10 seconds Quality of Service, Proprietary binary protocol Security)
- Display: AMOLED
- 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)
- 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)
- Emitted Wavelengths: 600 nm to 1000 nm, peak optical power less than 15 mW.
Usage Features:
- User Interface: The watch features an AMOLED display for user information and a control button for interaction.
- Control Button Modes:
- Press and hold: Used for turning the watch on and off.
- Short press (less than 2 seconds): Toggles between screens, releases from standby mode, and clears messages.
- Home Screen Display: Shows charge indicators (percentage and battery icon, turning red at 15%), Bluetooth connection status, local time (24-hour or 12-hour mode), and date.
- Power Saving: The display enters sleep mode after a short period of inactivity, and Bluetooth turns off when not in use for an extended period. A short press of the control button reactivates the display and automatically reconnects Bluetooth to the Polso™ App.
- Wearing the Watch:
- Can be worn on either the left or right wrist, but must remain on the same wrist after setup for optimal performance.
- Available in three sizes (Small/Medium/Large) based on wrist circumference.
- Positioned on clean, dry skin, with the back of the sensor head placed on top of the radial artery, touching the skin without making pressure marks.
- The wrist strap should be tightened to feel comfortable and keep the watch as close as possible to the hand.
- Taking a Measurement:
- Requires the user to sit comfortably, avoid talking, and remain still.
- Place the hand with the watch on a table or desk, near chest level.
- Initiate measurement by continuously holding the thumb on the ECG Finger Sensor.
- The watch emits one vibration to confirm initiation.
- The display shows a measurement screen with an ongoing PPG signal and status message (green for high signal quality, yellow for moderate, red for poor).
- Results are displayed after two short vibrations. If measurements fail, a dashed line appears, and an error message with one long vibration is given.
- Individual parameters can be viewed by cycling through them with the control button.
- Blood Pressure Initialization:
- Required every 30 days. An alert appears on the watch and app.
- Involves performing an accurate blood pressure reading with a standard reference device and recording it in the Polso™ App.
- The user must sit quietly for accurate initialization.
- A Polso™ Watch measurement must be taken within 5 minutes for initialization to be valid.
- History:
- Review up to 3 months of data in the Polso™ App.
- Displayed by individual parameter.
- Two display options: Tabular mode (historical data in table format, sorted by date and time, scrollable) and Graphic mode (historical data using a line graph, viewable by day, week, or month).
- Settings:
- Edit personal information (DOB, height, weight, gender, wrist used).
- Changes to personal details may require blood pressure initialization.
- System settings allow changes to time format, vibration, partial results display, and setting up a new watch.
- Turning Off: Press and hold the Control Button until the shutdown screen appears (about 3 seconds).
- Transferring to a New Android Device: Requires HCP assistance for data security.
Maintenance Features:
- Replacing the Wrist Strap:
- Uses a quick-release system.
- To remove: Hold the watch with the buckle upward, locate the small knob where the strap meets the case, slide it, and lift the strap. Repeat for the other side.
- To attach: Reverse the process, ensuring the buckle part of the strap is at the top.
- Cleaning and Disinfecting:
- Wipe outer surfaces with a dampened soft cloth (70% Alcohol).
- Pay particular attention to cracks, crevices, and hard-to-reach areas.
- Follow with a fresh wipe.
- Warning: Device must be off and not applied to a wrist. Improper cleaning may cause damage. Do not wash or immerse in water.
- Disposal: Dispose of in accordance with federal, state, and local law for routine/non-hazardous electronic waste. Do not mix with general household waste.
- Troubleshooting: Provides solutions for common issues such as no display, short battery life, measurement failure, and Bluetooth connection problems.
- Customer Support: Contact ChroniSense customer support at support@polsowatch.com for operational failures, accuracy concerns, or other issues.
Contraindications:
The Polso™ Watch is not intended for use by pregnant patients; patients with deformities or abnormalities preventing proper application to the wrist (e.g., swelling, irritation, injuries, localized infection, ulceration, skin lesions, scarification, tattoos, body art); patients with sustained or non-sustained ventricular/atrial arrhythmia (e.g., ventricular tachycardia, supraventricular tachycardia, atrial fibrillation, bigeminy, trigeminy), and left bundle branch block; patients with implantable defibrillators, pacemakers, neurostimulators, or other implantable/worn devices that may interfere with the watch; patients with Parkinson's disease, essential tremor, convulsive disorders, or other disorders preventing forearm rest; patients with compromised circulation or peripheral vascular disease; or patients with elevated levels of Methemoglobin (MetHb), Carboxyhemoglobin (COHb), or anomalous hemoglobins.
Warnings and Cautions:
- Not for diagnosis or treatment.
- Do not adjust medication or alter instructions based on readings without physician consultation.
- Not for use in conjunction with medical assist devices like Intra-Aortic Balloon Pump (IABP) or Left Ventricular Assist Device (LVAD).
- Avoid use in conjunction with systems generating high radiation or magnetic fields, or in environments with X-ray, MRI, CT, electrosurgery, or extreme lights.
- Not for use under medical treatment or with a cast, brace, or wrap-bandage.
- Not for use on wrists with restricted blood flow (e.g., tourniquet, pressure cuff, IV line).
- Contains small parts; keep away from children.
- Not for use during patient exercise or motion.
- Not for use on skin treated with injected dyes or substances that change blood pigmentation.
- SpO2, pulse rate, respiration rate, and blood pressure alarms are not provided.
- Do not use with a power supply when wet.
- Do not disassemble or attempt to repair the watch, charger stand, or power supply.
- Operate only with appropriate training by a certified HCP.
- Do not use with lotion or moisturizer; clean wrist before use.
- Remove jewelry or accessories from the wrist during measurements.
- Only measures while the patient is at rest.
- Use on the same wrist for all reference initialization measurements.
- Use only for indicated purposes.
- Do not use if the package is opened, appears used, or damaged.
- Avoid incorrect handling, excessive force, or dropping.
- Do not re-manufacture, recondition, or recycle.
- Avoid strong shocks or vibrations.
- Do not immerse in water or any other liquid.
- Misapplication with excessive pressure or mispositioning can result in inaccurate readings.
- Dispose of according to electronic waste regulations.
- Stop use and inform HCP if skin irritation or damage occurs.
- Do not let chemical products accumulate on the watch; clean immediately with 70% alcohol.
- Do not sterilize, autoclave, or immerse the watch in liquid.
- Do not use outside recommended temperature/humidity range.
- Do not use in potentially explosive atmospheres.
- Do not use if sensors are degraded (discolored, peeling, pitted).
- Keep out of reach of infants, toddlers, children, or pets.
- Use only specified USB cable and power supply.
- Do not touch, press, or rub display panels with abrasive materials.
- FCC compliance: This device complies with part 15 of the FCC Rules. It may not cause harmful interference and must accept interference received.
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