HUAWEI MLY-B10 D Smart Watch Graphite Black User Guide
- June 3, 2024
- Huawei
Table of Contents
HUAWEI MLY-B10 D Smart Watch Graphite Black User Guide
Quick Start Guide
Manufacturer Name: Huawei Device Co., Ltd.
MLY-B10
MLY-B11
Quick Start Guide
Safe Use
This device is a household product and is suitable for wrist blood pressure
measurement for adults aged 18 and above.
This device complies with IEC 80601-2-30.
[Warnings]
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Do not diagnose or treat yourself based on the measurement results. Follow your doctor’s advice instead, because self-diagnosis may worsen the condition. Send your measurement results to your doctor or medical staff who are familiar with your physical condition.
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Do not use this device in areas containing high frequency (HF) surgical equipment, magnetic resonance imaging (MRI) equipment, and computerized tomography (CT) scanners.
This may result in incorrect operation of the device and/or cause an inaccurate reading. -
Consult with your physician before using this device if you have common arrhythmias such as atrial or ventricular premature beats or atrial fibrillation; arterial sclerosis; poor perfusion; diabetes; pregnancy; preeclampsia or renal disease. NOTE that any of these conditions in addition to patient moving, trembling, or shivering may affect the blood pressure measurement reading.
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Measurements may be inaccurate for patients suffering from blood circulation disorders and blood diseases.
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Do not use this monitor on infants, toddlers, children or persons who cannot express themselves.
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This device has not been validated for use on pregnant patients.
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Consult with your physician before using this device if you have had a mastectomy.
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The following should use this product for blood pressure measurements under the guidance of a doctor:
• Patients with limb shaking syndrome and people who cannot bend their arms by themselves.
• People who have wounds or inflammation in their arms or wrists.
• People whose arms or wrists are having an infusion, blood transfusion, or a catheter inserted.
• Patients who are using monitoring medical equipment. -
The parts of the product do not support repair and maintenance when it is in use.
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The user must be an intended operator.
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Keep the charging base (with the power cable) away from infants, toddlers or children to avoid the risk of strangulation.
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DO NOT disassemble or attempt to repair this device by yourself.
[Precautions]
- This device supports a wrist circumference range of 13.0 cm to 20.0 cm for blood pressure measurements. If the wrist circumference exceeds the range, the accuracy of blood pressure measurement may be affected.
- Observe your arm during the measurement to ensure that this device is not affecting the blood flow.
- If the airbag is excessively inflated, it may cause discomfort to your wrist and cause blood stasis or paralysis. In this case, remove the device.
- Do not take blood pressure measurements too often as bruising may occur due to blood flow interference.
- Portable and RF communication devices may affect this device. Do not place the device near or on top of other devices. Otherwise, the radiation may increase and the ant interference capability may decrease.
- This product may cause adverse events such as allergies. In this case, stop wearing it and consult a doctor.
- Ensure that the electromagnetic interference is no more than 3 V/m. Possible sources of interference include microwaves and X-rays.
- The device may worsen the conditions for people who have wounds or inflammation in their arms or wrists.
- The device may cause harm to people whose arms or wrists are having an infusion, blood transfusion, or a catheter inserted due to its temporary interference with the flow of blood.
- Use of this device may cause the temporary loss of function of the monitoring medical electrical (ME) equipment used simultaneously on the same limb.
- You can view the remaining power of the device on the device screen.
- If the measured blood pressure is abnormal, you can take a measurement again 5 minutes later or consult your doctor.
- The accuracy of the pressure sensor has been strictly tested, so you do not need to check it. If you have any questions, please call the customer service hotline.
- If you use a defibrillator while wearing the watch, the blood pressure measurement feature of the watch may be affected. Please contact the customer service hotline if you have any questions about it.
The validity period of this product is 3 years.
Product Information
1. Intended Use
The Wrist Blood Pressure Monitor is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population with wrist circumference ranging from 13.0 to 20.0cm (5.12-7.87 inches).
1.2 Contraindications
Allergic reactions to this product.
1.3 Performance Indicators
1.4 Structure Diagram and Packing List
This product consists of a device body, a cuff (strap), and a wireless charging cradle. For its materials, see the label on the package.
Packing list:
- Device (with an L-sized strap and an L-sized airbag) x 1
- Independent cover x 1
- Quick Start Guide x 1
- Warranty Card x 1
- M-sized airbag x 1
- L-sized and M-sized airbag clothing’s (spare) x 1
- Wearing Guide x 1
- M-sized strap (without the clasp) x 1
- Wrist circumference ruler x 1
- Charging cradle (with the power cable) x 1
Blood Pressure Measurement
2.1 Principles
This device measures blood pressure by using the oscillometric method. As the strap (airbag) pressure increases, the device extracts and analyzes the signals of pressure oscillations in the airbag using the pressure sensor, and automatically calculates the high pressure (systolic pressure), low pressure (diastolic pressure), and pulse rate.
2.2 Working Environment
Precautions
- Keep the device away from electromagnetic interference, vibration, and noise.
- Failure to comply with the working environment requirements specified in this guide will cause the product to fail to reach the claimed performance specifications or damage the parts.
2.3 Measurement Requirements
Any blood pressure measurement data may be influenced by the location of the measurement, posture (standing, sitting, or lying down), movement, or physiological conditions.
To ensure the accuracy of the measurements, observe the following requirements:
- Rest for 5 minutes before a measurement and keep your body naturally relaxed until the measurement is complete. Do not perform the measurement when you feel emotional or stressed.
- Perform a measurement in a quiet environment. Do not speak, bend your fingers, or move your body or arms during the measurement.
- Rest your wrist for 1 to 2 minutes or longer before you perform the next measurement. During this period of time your arteries will return to how they were before the blood pressure was measured.
Measurement posture:
- Remove the device if it does not start deflating during a blood pressure measurement.
- Press and hold the Up button for more than 15 seconds to restart the device.
Description of GUI abbreviations
For details about precautions, operation instructions, maintenance, calibration, and FAQs, see the user guide in the Huawei Health app.
2.4 Entering the Static Mode
This feature is mainly for professionals to enter the static pressure test mode of this device, and to use the standard pressure gauge to test its static performance.
Storage and Maintenance
The accuracy of the pressure sensor in this device has been strictly tested, so you do not need to check it by yourself. If you have any questions, please call the customer service hotline.
3.1 Storage Requirements
Storage and transportation conditions:
Temperature: –20°C to +55°C
Humidity: 10% RH to 95% RH (excluding condensation)
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.
It is recommended that you put the airbag in a box or storage bag 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 sources or exposed fire sources, such as
electric heaters, microwaves, ovens, water heaters, fireplaces, candles, and
other places that may generate high temperatures.
To prevent injuries, malfunctions, or explosions, do not allow children or
pets to swallow or bite the device or its accessories.
3.2 Transportation Conditions
Avoid strong impacts, direct collisions, and exposure to sunlight or rain during transportation.
3.3 Cleaning/Accessory Replacement
For details, open the Huawei Health app, touch Devices and then the connected
device, and view the User Guide on the device details screen.
Note: Replacing the original parts with third-party parts may cause
measurement errors.
3.4 Replace the airbag clothings
Replace the airbag clothing when it becomes dirty. It is recommended that you replace the clothing after six months of use. For details, open the Huawei Health app, touch Devices and then the connected device, and view the User Guide on the device details screen.
[Precautions]
Do not perform any maintenance by yourself. If the product has quality issues or you have any questions about how to use its blood pressure measurement feature properly, call the customer service hotline.
Explanations of Symbols and Figures
Declaration of Electromagnetic Compatibility (EMC)
MLY-B10/MLY-B11 manufactured by Huawei Device Co., Ltd. conforms to IEC
60601-1-2:2014/
AMD1:2020 Electromagnetic Compatibility (EMC) standard.
Further documentation in accordance with this EMC standard is available at
https://consumer.huawei.com/en/. Refer to the EMC information for
MLY-B10/MLY-B11 on the website.
Copyright © Huawei 2022. All rights reserved.
THIS DOCUMENT IS FOR INFORMATION PURPOSE ONLY, AND DOES NOT CONSTITUTE ANY KIND OF WARRANTIES.
Trademarks and Permissions
The Bluetooth® word mark and logos are registered trademarks owned by
Bluetooth SIG,
Inc. and any use of such marks by Huawei Technologies Co., Ltd. is under
license. Huawei
Device Co., Ltd. is an affiliate of Huawei Technologies Co., Ltd.
Other trademarks, product, service and company names mentioned may be the
property of their respective owners.
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
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Using an unapproved or incompatible power adapter, charger or battery may cause fire, explosion or other hazards.
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Ideal temperatures are 5°C to 40°C.
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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.
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If the ambient temperature is too high, the wireless charger may stop working. If this occurs, you are advised to stop wireless charging.
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To keep the wireless charger in good condition, avoid using it inside a vehicle.
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Adult supervision is advised if children are to use or come into contact with this product.
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Please consult your doctor and the device manufacturer to determine if operation of your device may interfere with the operation of your medical device.
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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.
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Some wireless devices may affect the performance of hearing aids or pacemakers. Consult your service provider for more information.
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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 device and the battery away from excessive heat and direct sunlight. Do not place them on or in heating devices, such as microwave ovens, stoves, or radiators.
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Observe local laws and regulations while using the device. To reduce the risk of accidents, do not use your wireless device while driving.
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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.
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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.
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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.
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The device has undergone testing and has demonstrated water resistance in certain environments.
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The device has a built-in, non-removable battery. Do not attempt to remove the battery, otherwise the device may be damaged.
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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.
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When charging the device, make sure the power adapter is plugged into a socket near the devices and is easily accessible. Unplug the charger from the electric socket and from the device when the device is not used for a long time.
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Unplug the charger from electrical outlets and the device when not in use.
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Do not place sharp metal objects, such as pins, near the microphone. The microphone may attract these objects and result in injury.
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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.
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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.
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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.
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Ensure that the power adapter meets the requirements of IEC/EN 62368-1 and has been tested and approved according to national or local standards.
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Protect the wearable and its accessories from strong impact, strong vibration, scratches, and sharp objects, as these may damage the device.
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Make sure that the wearable and its accessories stay clean and dry
Disposal and recycling information
The crossed-out wheeled-bin symbol on your product, battery, literature or
packaging reminds you that all electronic products and batteries must be taken
to separate waste collection points at the end of their working lives; they
must not be disposed of in the normal waste stream with household garbage. It
is the responsibility of the user to dispose of the equipment using a
designated collection point or service for separate recycling of waste
electrical and electronic equipment (WEEE) and batteries according to local
laws.
Proper collection and recycling of your equipment helps ensure electrical and
electronic equipment (EEE) waste is recycled in a manner that conserves
valuable materials and protects human health and the environment, improper
handling, accidental breakage, damage, and/or improper recycling at the end of
its life may be harmful for health and environment.
For more information about where and how to drop off your EEE waste, please
contact your local authorities, retailer or household waste disposal service
or visit the website https://consumer.huawei.com/en/.
Reduction of hazardous substances
This device and any electrical accessories are compliant with local applicable rules on the restriction of the use of certain hazardous substances in electrical and electronic equipment, such as EU REACH, RoHS and Batteries (where included) regulations, etc. For declarations of conformity about REACH and RoHS, please visit our website https://consumer.huawei.com/certification.
EU regulatory conformance
RF exposure requirements
Your device is a low-power radio transmitter and receiver. As recommended by international guidelines, the device is designed not to exceed the limits established by the European Commission for exposure to radio waves.
Statement
Hereby, Huawei Device Co., Ltd. declares that this device MLY-B10/MLY-B11 is
in compliance with the essential requirements and other relevant provisions of
Directive 2014/53/EU.
The most recent and valid version of the DoC (Declaration of Conformity) can
be viewed at https://consumer.huawei.com/certification.
This device may be operated in all member states of the EU.
Observe national and local regulations where the device is used.
This device may be restricted for use, depending on the local network.
Frequency bands and power
(a) 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.
(b) Maximum radio-frequency power transmitted in the frequency bands in which
the radio equipment operates: The maximum power for all bands is less than the
highest limit value specified in the related Harmonized Standard.
When charging the device, ensure it is 20 cm away from your body.
The frequency bands and transmitting power (radiated and/or conducted) nominal
limits applicable to this radio equipment are as follows: MLY-B10/MLY-B11:
Bluetooth: 12 dBm, NFC: 42dBμA/m@10 m, WPT: 100 kHz-119 kHz,135 kHz-140 kHz:
42dBμA/m@10 m, 119 kHz~135 kHz: 66 descending 10 dB/dec above 0.119 MHz@10m,
140 kHz-148.5 kHz: 37.7dBμA/m@10 m.
Accessories and Software Information
It is recommended that the following accessories should be used:
Charging cradle: CP81-1 Wrist circumference ruler Independent cover
The product software version is 2.1.0.127
Software updates will be released by the manufacturer to fix bugs or enhance
functions after the product has been released. All software versions released
by the manufacturer have been verified and are still compliant with the
related rules.
All RF parameters (for example, frequency range and output power) are not
accessible to the user, and cannot be changed by the user.
For the most recent information about accessories and software, please see the
DoC (Declaration of Conformity) at
https://consumer.huawei.com/certification.
Please go to Settings > About > Regulatory information on the device to
view the E-label screen.
31500HCP_01
MLY-B10
MLY-B11
References
Read User Manual Online (PDF format)
Read User Manual Online (PDF format) >>