Huawei Watch D2 (LCA-B10, LCA-B11) Manual

Safe Use

This device is a household product used for measuring wrist blood pressure. It is suitable for use by adults over 18 years of age.

If a defibrillator is used on a person who is wearing this device, the blood pressure measurement function of this device may be affected.

If you have any questions about this device, please call the customer service hotline. For details, visit https://consumer.huawei.com/en/support/hotline/.

Warnings

• This device has not been validated for use on newborn babies or those who are pregnant.
• If your wrist circumference is less than 13.0 cm or more than 21.0 cm, the accuracy of blood pressure measurements may be affected.
• NEVER diagnose, treat yourself, or adjust your medications based on the readings of this device. ALWAYS consult with your physician and take medicines as prescribed. ONLY a physician is qualified to diagnose and treat high blood pressure.
• Do not use this device if you are allergic to nylon, fluororubber, or thermoplastic polyurethanes.
• Do not wear this device when receiving intravenous infusions or blood transfusions, or when having a catheter inserted through the wrist, as doing so may restrict blood flow and cause injury.
• Do not use this device if your wrist is wounded or if you are undergoing medical treatment as this may cause further injury.
• Consult with your physician before using this device if you have had a mastectomy or lymph node dissection.
• Consult with your physician before using this device if you are undergoing intravascular intervention or treatment, or if you have an arteriovenous (A-V) shunt, as doing so may temporarily restrict blood flow and cause injury.
• Ensure that this device is not restricting blood flow by observing the arm when taking blood pressure measurements.
• Do not take blood pressure measurements too often as bruising may occur if your blood flow is being restricted.
• Prolonged wear may cause friction or pressure which may irritate your skin. Please remove this device from time to time to let your wrist rest.
• This device may temporarily compromise other electrical medical monitoring equipment being used simultaneously on the same arm.
• Do not place this device near portable or mobile radio frequency communication equipment, as this may affect the functions and accuracy of this device.
• Do not use this device near high frequency surgical equipment, magnetic resonance imaging equipment, or computerized tomography scanners, as this may affect the functions and accuracy of this device.
• Do not use this device in an oxygen-rich environment or close to flammable gases.
• Keep the charging cradle and power cable away from newborn babies, infants, and children to minimize the risk of strangulation.
• Keep this device away from newborn babies, infants, and children as it contains many small parts which may be a choking hazard.
• Do not disassemble or tamper with this device, as this may damage it and/or cause injury.
• This device comes with a non-removable battery. Do not try to replace or fix the battery within its service life, as doing so may damage this device and/or cause injury.
• Do not use any accessories, transducers, or cables other than the ones specified or provided by the manufacturer of this device, as doing so could increase electromagnetic emissions or decrease electromagnetic immunity.
• Do not use this device while it is next to, underneath, or on top of another device unless it is absolutely necessary to do so, and even then, only with proper supervision of both devices.
• This device is designed for personal use. It is not to be used in healthcare centers where it would be in close proximity to high-frequency surgical equipment, outside the RF-shielded rooms next to MRI machines, or in places with high-frequency interference and high electromagnetic interference.

Precautions

• Keep this device clean. Stop using this device immediately and consult with your physician if it causes skin irritation or any other side effects.
• You may have an allergic reaction to this device. Stop using this device immediately and consult with your physician promptly if you experience any side effects from using this device.
• If the strap does not deflate after a blood pressure measurement, please remove the strap.
• Do not use this device with other medical electrical equipment, as this may affect the functions and accuracy of this device.
• Consult with your physician before using this device if you have arrhythmias (such as atrial or ventricular premature beats, or atrial fibrillation), arteriosclerosis, malperfusion, diabetes, preeclampsia, or kidney disease. Any of these conditions may affect the accuracy of blood pressure measurements.
• Moving or trembling during a blood pressure measurement may affect the accuracy of the measurement.
• This device has been carefully tested. It can reach the required level of accuracy for blood pressure measurements, and it has been approved for use for the duration of its validity period. Its performance may deteriorate beyond the validity period.
• Users of this device should be intended operators, either patients or operators assisting patients, and features should be used in accordance with this guide. This device can be used by multiple users at different times in guest mode.
• By default, this device runs and monitors data in the background and automatically uploads related logs.
• Do not use this device in high-use environments such as medical clinics or physician offices.

Basic Information

Structure and Composition

This device consists of a device body, a strap (with an airbag inside), and a wireless charging cradle.

Intended Purpose

This device is a digital self-monitor intended for use in measuring blood pressure, 24-hour ambulatory blood pressure, and pulse rate in adult population with wrist circumference ranging from 13.0 cm to 21.0 cm. Measurement results should not be used as the basis for diagnosis.

Contraindications

No contraindications have been found.

Clinical Benefit

This device helps users perform blood pressure monitoring and 24-hour ambulatory blood pressure self-monitoring, and assists users who have been diagnosed with hypertension in identifying episodes of intermittent hypertension during daily activities.

Data transmission

This device transmits 2.4-GHz RF signals for device updates and data transmission. Do not use it in places where the use of radio frequency is restricted. After Bluetooth is disconnected, blood pressure measurements continue to work as normal, but the software version fails to update and data cannot be synced.

Performance Indicators

This device complies with IEC 80601-2-30, and has been clinically tested in accordance with ISO 810602:2018 and AMD1:2020. The clinical trial included a resting blood pressure monitoring test and an ambulatory blood pressure monitoring test. The resting blood pressure monitoring test was conducted on more than 85 subjects. The average deviation of their systolic and diastolic blood pressures did not exceed ±5 mmHg, and the standard deviation of their systolic and diastolic blood pressures did not exceed 8 mmHg. The ambulatory blood pressure monitoring test was conducted on more than 35 subjects. The average deviation of their systolic and diastolic blood pressures did not exceed ±5 mmHg, and the standard deviation of their systolic and diastolic blood pressures did not exceed 8 mmHg, in this instance either.

Structural Diagram and Packing List

Notes:

• The air vent is located where the device body and the strap meet.
• Press the Down button to start a blood pressure measurement and press the Up button to stop it.

Packing list:

Powering on or restarting automatically after charging

Line up the charger with the charging area on the back of the device, then connect the cable to a power supply and wait for the battery level to appear on the screen.

Set Up Your Device

1. Use your phone to scan the QR code, or search for "Huawei Health" in AppGallery or on consumer.huawei.com to download the Huawei Health app.
2. Open the Huawei Health app, go to the devices screen, choose the devices you wish to add, and follow the onscreen instructions to complete pairing.

Measuring Your Wrist Circumference and Wearing the Device

1. Measure your wrist's circumference at about the width of two fingers away from the bottom of your palm.
2. Pull the tail of the measuring tool through the buckle on the head until it touches the arm to avoid being too tight, and record the number shown by the arrow.
   
3. Select the strap size based on the scale on the ruler. (M: 5–11; L: 12–20).
   

Measuring Your Blood Pressure

Principles

This device measures blood pressure via the oscillometric method. As the wrist strap (airbag) pressure increases, the pressure sensor in the device strap monitors and analyzes the pressure oscillations and automatically calculates your systolic and diastolic blood pressure and your pulse rate.

Your Surroundings

Notes

• Keep the device away from electromagnetic interference, vibration, and noise.
• This device will not perform optimally if your surroundings do not meet the requirements.
• Before measuring your blood pressure, ensure that your surroundings meet the requirements for the device to function optimally. Extreme temperatures, humidity, or altitude may affect the accuracy of this device. If your surroundings reach temperatures outside of the device's optimal range, place the device in a safe place that is within the specified operating temperature range for about one hour before using it.
• Do not use this device while it is charging.
• This device is not intended for self-use in public places.
• This device can only be connected via Bluetooth, and is capable of transmitting update packages and blood pressure data. You'll need to restore the device to its factory settings before connecting it to another device (if previously connected to a device).
• Do not use this device in a moving vehicle such as in a car, on a train, or on an aircraft.

Measurement Requirements

Blood pressure measurement results may be affected by measurement position, posture, movements, and physiological conditions. To ensure the accuracy of your measurements, please make sure of the following:

• Avoid eating, drinking alcohol, smoking, and exercising for at least 30 minutes before measuring your blood pressure.
• Rest for 5 minutes before a blood pressure measurement and keep your body relaxed throughout the measurement. Avoid measuring your blood pressure when you feel emotional or stressed.
• Perform blood pressure measurements in a quiet environment. Do not speak or move your fingers, arms, or body during blood pressure measurements.
• If you are taking more than one blood pressure measurement in a row, rest your wrist for at least 1 to 2 minutes between each measurement so that your arteries have time to return to their regular state.
• If your blood pressure measurement result falls outside the normal range, rest for 5 minutes and measure your blood pressure again or consult with your physician.

Your Posture

During a measurement, it is recommended that you keep comfortably seated, with feet flat on the floor, legs uncrossed, back and arm supported, and this device at the level of your heart. Try to maintain the recommended posture from the beginning of a blood pressure measurement until the device displays the measurement result. Any deviation from the recommended posture may affect the measurement result. For details about the standard measurement posture, see the Wearing Guide.

Before Measuring your Blood Pressure

1. Setting your wrist circumference
   When you use the Blood pressure or Ambulatory Blood Pressure Monitoring (ABPM) app on the device for the first time, you will be prompted to set your wrist circumference. Use the ruler provided to help you. Check whether the airbag installed on your device is the right size for your wrist circumference.
2. Changing the measurement unit
   The default unit is mmHg. If you want to change the unit, swipe up on the screen in the Blood pressure or Ambulatory Blood Pressure Monitoring (ABPM) app to access Settings and then change the unit.

Performing a Single Blood Pressure Measurement

1. Enter the app list, select the Blood pressure app, and start a measurement. The device will then start to inflate automatically and it will display the pressure data on the screen in real time. You can also press the Down button to immediately start a blood pressure measurement.
2. Once the measurement is complete, the device will automatically deflate and display the measurement result.

Ambulatory Blood Pressure Monitoring (ABPM)

1. Enter the app list, select the Ambulatory Blood Pressure Monitoring (ABPM) app, and set an ambulatory blood pressure monitoring plan.
   
2. Once you have set an ambulatory blood pressure monitoring plan, the device will perform measurements according to the plan.
   
3. Once a measurement is complete, the device will automatically deflate and display the measurement result.
   

Note: Measurement indicators include the 24-hour average value, daytime average value, nighttime average value, maximum value, minimum value, median, standard deviation, number of measurements, blood pressure load, coefficient of variation, nocturnal blood pressure dipping, and morning blood pressure surge.

Stopping a Blood Pressure Measurement

• During a blood pressure measurement, press the Up button or touch the cancel button on the screen to exit the measurement.
• The system will automatically stop a measurement once it is complete.

Notes:

• If the device does not automatically deflate after a blood pressure measurement, please unfasten the strap.
• To restart or turn off the device, press and hold the Up button until the device screen displays restart and shutdown options and select an option as needed.
• The device can display the results of the last 100 single blood pressure measurements and the last 300 ambulatory blood pressure measurements.
• If the device is restored to its factory settings, all of your data will be deleted. The only way to delete data is to restore your device to its factory settings.
• In this guide, high pressure refers to systolic blood pressure, and low pressure refers to diastolic blood pressure.

Measurement Irregularities and Solutions

GUI Abbreviations

Static Pressure Test Mode

This involves dedicated personnel testing the static performance of the device through a stringent process, after entering the device's static pressure test mode.

Maintenance

Precautions

• The user can only replace the strap (including the airbag). For details about how to replace the strap, see the Wearing Guide. Please note that replacing an original component with a nonHUAWEI component may cause measurement errors.
• No maintenance should be attempted during blood pressure measurements. The blood pressure-related software comes pre-installed on the device. The device supports over-the-air updates (when paired with a phone). The blood pressure-related software is updated whenever the device is updated.
• This device is equipped with a non-removable battery. Do not try replacing or removing it, as doing so may damage this device and/or cause injury.
• The device's pressure measurement system has been independently verified, and there is no need to verify this on your own. If you require any assistance, please contact an authorized Huawei service center.
• If required, Huawei can provide the circuit diagram, list of components, illustrations, calibration details, and other information related to the repairable parts of the device to the maintenance personnel designated by Huawei. If you have any questions about repairs or spare parts, contact an authorized Huawei service center.

Storing Your Device

• Store the device in a clean and safe place.
• Do not store the device in places in which it may be exposed to direct sunlight, moisture, high temperatures, dampness, dust, salt, chemicals, or corrosive gases.
• Avoid strong impacts, direct collisions, and exposure to sunlight or rain.

Storage and transportation conditions:
Temperature: –20°C to +55°C
Humidity: 10% RH to 95% RH (non-condensing)
Atmospheric pressure: 80 kPa to 105 kPa

Do not store the device in the following environments:

• Environments with water, high temperatures, dampness, direct sunlight, dust, or salt.
• Environments that can generate tilts, vibrations, or impacts.
• Environments where chemicals are stored or corrosive gases are generated.

Store the spare strap (including the airbag) carefully when you are not using it.

Do not put the device in places that are exposed to direct sunlight, such as on a car dashboard or on a window sill.

Keep the device away from heat and fire sources, such as electric heaters, microwave ovens, roasters, water heaters, furnace fires, candles, or other places where it may be exposed to high temperatures.

To prevent injuries, malfunctions, or explosions, keep the device out of reach of children and pets and make sure that they do not accidentally swallow or bite the device or its accessories.

Cleaning Your Device

• Keep the device clean and dry.
• If the watch body or strap (including the airbag) is dirty, use a dry soft cloth to clean it. If the dirt is difficult to remove, fully twist and dry a cloth dipped in clean water or 75% rubbing alcohol, and then use it to wipe the area before wearing the device.

Precautions

• When cleaning the device body and the strap (including the airbag), take care to ensure that no liquid gets into the device.
• Do not immerse the watch body or strap (including the airbag) in water, and do not dry them by using a drying device.
• Do not use organic solvents (such as hand sanitizer, soapy water, or other acidic solvents), or strong detergents or disinfectants to clean the device body and the strap (including the airbag).
• Do not use sharp or hard objects (such as steel wire cleaning balls) to wipe the device or its accessories.

Environmental Protection Statement

• Do not dispose of this device or its accessories in a garbage can.
• Please comply with all relevant laws and regulations regarding the disposal of this device and its accessories, and support recycling efforts.
• This device and its accessories shall be disposed of according to the local environmental protection regulations.

Symbols and Figures

Figures and Symbols	Description
	Type BF Applied Part
	Caution
	Indicates that the product is dust-proof and water-resistant.
	Indicates that the product is capable of being recycled.
	Short-distance radio technology, Bluetooth certification mark.
	Indicates that this device is endorsed by the Forest Stewardship Council, a nonprofit NGO, which is committed to promoting sustainable forest management.
	Indicates that you should recycle the object when you dispose of it.
	Non-ionizing electromagnetic radiation
	Medical device
	CE mark. Indicates that the device complies with EU 2017/745.
	Follow this guide carefully when using this device.
	Authorized representative in the European Union
	Manufacturer
	The temperature range that the device can safely tolerate
	The humidity range that the device can safely tolerate
	The atmospheric pressure range that the device can safely tolerate
	Serial number
	Model number
	Unique device identifier
	Date of manufacture
	How to wear the device properly
	Remove the packaging and dispose of it in the appropriate recycling bin according to local laws and regulations.
	Recyclable non-corrugated fiberboard (board)
	Importer

Note: The two digits after the 16-digit characters on the back of the product indicate the manufacturing year and month. The first digit is the last digit of the year, the second digit indicates the month, and the months from 1 to 12 are represented by 1 to 9, A, B, and C respectively. For example, 42 corresponds to February 2024.

The last eight digits of the charging cradle S/N indicate the year (one digit), month (one digit), and serial number (six digits). For instance, if the last eight digits are 48xxxxxx, the charging cradle was manufactured in August 2024.

Safety information

THIS DOCUMENT IS FOR INFORMATION PURPOSE ONLY, AND DOES NOT CONSTITUTE ANY KIND OF WARRANTIES.

Privacy Policy
To better understand how we protect your personal information, please see the privacy policy at https://consumer.huawei.com/privacy-policy.

Blasting Caps and Areas
Turn off your mobile phone or wireless device when in a blasting area or in areas posted turn off "two-way radios" or "electronic devices" to avoid interfering with blasting operations.

Petrol stations and explosive atmospheres
In locations with potentially explosive atmospheres, obey all posted signs to turn off wireless devices such as your phone or other radio equipment. Areas with potentially explosive atmospheres include fuelling areas, below decks on boats, fuel or chemical transfer or storage facilities, areas where the air contains chemicals or particles, such as grain, dust, or metal powders.

Operation and safety

Please read all of the safety information carefully before using your device to ensure its safe and proper operation and to learn how to dispose of your device properly.

• Using an unapproved or incompatible power adapter, charger or battery may cause fire, explosion or other hazards.
• To prevent possible hearing damage, do not listen at high volume levels for long periods.
• Ideal operating temperatures are 5°C to 40°C.
• Avoid placing metal objects on the surface of the wireless charging cradle, as they could cause the equipment to heat up and malfunction. Only use the wireless charging cradle in environments with an ambient temperature ranging from 5°C to 40°C.
• If the ambient temperature is too high, the wireless charger may stop working. If this occurs, you are advised to stop wireless charging.
• To keep the wireless charger in good condition, avoid using it inside a vehicle.
• Adult supervision is advised if children are to use or come into contact with this product.
• Please consult your doctor and the device manufacturer to determine if operation of your device may interfere with the operation of your medical device.
• Switch off your wireless device when requested to do so in hospitals, clinics or health care facilities. These requests are designed to prevent possible interference with sensitive medical equipment.
• Switch off your wireless device whenever you are instructed to do so by airport or airline staff. Consult the airline staff about the use of wireless devices on board the aircraft, if your device offers a 'flight mode' this must be enabled prior to boarding an aircraft.
• Some wireless devices may affect the performance of hearing aids or pacemakers. Consult your service provider for more information.
• Pacemaker manufacturers recommend that a minimum distance of 15 cm be maintained between a device and a pacemaker to prevent potential interference with the pacemaker. If you are using a pacemaker, hold the device on the side opposite the pacemaker and do not carry the device in your front pocket.
• Keep the battery away from fire, excessive heat, extremely low air pressure and direct sunlight. Do not place it on or in heating devices. Do not disassemble, modify, throw, or squeeze it. Do not insert foreign objects into it, submerge it in liquids, or expose it to external force or pressure, as this may cause it to leak, overheat, catch fire, or even explode.
• Observe local laws and regulations while using the device. To reduce the risk of accidents, do not use your wireless device while driving.
• To prevent damage to your device's parts or internal circuits, do not use it in dusty, smoky, damp or dirty environments or near magnetic fields.
• Do not use, store or transport the device where flammables or explosives are stored (in a gas station, oil depot, or chemical plant, for example). Using your device in these environments increases the risk of explosion or fire.
• Dispose of this device, the battery, and accessories according to local regulations. They should not be disposed of in normal household waste. Improper battery use may lead to fire, explosion, or other hazards.
• Do not attempt to replace the battery yourself — you may damage the battery, which could cause overheating, fire, and injury. The built-in battery in your device should be serviced by Huawei or an authorised service provider.
• If you experience skin discomfort when wearing the device, take it off and consult a doctor.
• If the battery leaks, ensure that the electrolyte does not make direct contact with your skin or eyes. If the electrolyte touches your skin or splashes into your eyes, immediately flush with clean water and consult a doctor.
• Do not place sharp metal objects, such as pins, near the microphone. The microphone may attract these objects and result in injury.
• Wireless devices may interfere with the airplane's flight system. Do not use your device where wireless devices are not allowed according to the airplane company's regulations.
• To ensure the best audio performance of your device's microphone, use a cloth to wipe the area of the microphone which has been exposed to water. Do not use the microphone until the wet areas are totally dry.
• Protect the wearable and its accessories from strong impact, strong vibration, scratches, and sharp objects, as these may damage the device.
• Make sure that the wearable and its accessories stay clean and dry.
• Ensure that the power adapter meets the safety requirements of IEC/EN 62368-1 and has been tested and approved according to national or local standards.
• Please report to the manufacturer and the competent authority of the Member State in which you are established about any serious incident that has occurred in relation to this device.
• This device contains a coin, button, or small-sized cell battery. Do not swallow the battery, as it constitutes a chemical burn hazard.
• If the coin, button, or small size cell battery is swallowed, it can cause severe internal burns in just 2 hours and can lead to death.
• Keep new and used batteries away from children. If the battery compartment does not close securely, stop using the product and keep it away from children. If you think batteries might have been swallowed or placed inside any part of the body, seek immediate medical attention.

Frequency bands and power
Frequency bands in which the radio equipment operates: Some bands may not be available in all countries or all areas. Please contact the local carrier for more details.

Bluetooth 2.4GHz: 15.5 dBm, NFC 13.56 MHz: 42 dBμA/m at 10 m, Watch Wireless Charger 110.5 kHz-119 kHz, 135 kHz-140 kHz: 42dBμA/m at 10 m, 119 kHz~135 kHz: 66 descending 10 dB/dec above 119 kHz at 10m, 140 kHz-148 kHz: 37.7dBμA/m at 10 m.

Please visit https://consumer.huawei.com/en/support/hotline for recently updated hotline and email address in your country or region.

Please go to Settings > About > Regulatory information on the device to view the E-label screen.

Lotus NL B.V.
Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands.

Huawei Device Co., Ltd.
No.2 of Xincheng Road, Songshan Lake Zone, Dongguan, 523808 Guangdong, P.R. China