Huawei MLY-B10 D Manuel utilisateur

Quick Start Guide

Guide de démarrage rapide

Guía de inicio rápido



Panduan Permulaan Pantas

MLY-B10

MLY-B11

Manufacturer Name: Huawei Device Co., Ltd.

Manufacturer's registered address: No.2 of Xincheng Road, Songshan Lake Zone,

Dongguan, 523808 Guangdong, P.R.China

Issue Date: 2022-04

1

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]

1. 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



2. Do not use this device in areas containing high frequency (HF) surgical equipment, mag-

netic resonance imaging (MRI) equipment, and computerized tomography (CT) scanners.

This may result in incorrect operation of the device and/or cause an inaccurate reading.

3. Consult with your physician before using this device if you have common arrhythmias such





-

ment reading.



and blood diseases.

5. Do not use this monitor on infants, toddlers, children or persons who cannot express them-

selves.

6. This device has not been validated for use on pregnant patients.

7. Consult with your physician before using this device if you have had a mastectomy.

8. The following should use this product for blood pressure measurements under the guid-

0. Safe Use

Quick Start Guide

2

ance of a doctor:

 Patients with limb shaking syndrome and people who cannot bend their arms by them-

selves.

 

 People whose arms or wrists are having an infusion, blood transfusion, or a catheter

inserted.

 Patients who are using monitoring medical equipment.

9.The parts of the product do not support repair and maintenance when it is in use.

10.The user must be an intended operator.

11.Keep the charging base (with the power cable) away from infants, toddlers or children to

avoid the risk of strangulation.



[Precautions]

1. This device supports a wrist circumference range of 13.0 cm to 20.0 cm for blood pres-

sure measurements. If the wrist circumference exceeds the range, the accuracy of blood









blood stasis or paralysis. In this case, remove the device.

4. Do not take blood pressure measurements too often as bruising may occur due to blood







interference capability may decrease.

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6. This product may cause adverse events such as allergies. In this case, stop wearing it

and consult a doctor.

7. Ensure that the electromagnetic interference is no more than 3 V/m. Possible sources of

interference include microwaves and X-rays.



their arms or wrists.

9. The device may cause harm to people whose arms or wrists are having an infusion,



blood.

10. Use of this device may cause the temporary loss of function of the monitoring medical

electrical (ME) equipment used simultaneously on the same limb.

11. You can view the remaining power of the device on the device screen.

12. If the measured blood pressure is abnormal, you can take a measurement again 5

minutes later or consult your doctor.

13. 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.





have any questions about it.

The validity period of this product is 3 years.

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1. 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



Name Wrist Blood Pressure Monitor

Models MLY-B10, MLY-B11

Embedded Software Version Blood Pressure V1

Type of Protection Against Electric Shock Internal power supply

Degree of Protection Against Electric

Shock Type BF (Airbag, the bottom of the device)

Level of Protection Against Harmful Liq-

uids and Particles Entering Inside IP68 (Complies with the IP68 protection level of IEC

60529)

Level of Safety Against Flammable An-





Non-AP/APG type

Running Mode Continuous running

Power Supply Rechargeable Li-ion Polymer Battery



5

Battery Life Information Typical usage: 7 days



TM

-

-





times per day. The battery life depends on the usage

habits and storage environment.

Typical battery life: A new battery on a full charge will last

for approximately 500 cycles when operating at room

temperature (25°C).

Durable period (Service life) 

clothings (spare): 0.5 years

Blood Pressure Measurement

Measuring Method 

Measurement Range Pressure: 0–300 mmHg (0–40 kPa)

Pulse rate: 40–180 times/min

Diastolic blood pressure: 40–130 mmHg (5.3–17.3 kPa)

Systolic blood pressure: 60–230 mmHg (8–30.7 kPa)

Precision Error Pressure: ±3 mmHg (±0.4 kPa)

Pulse rate: ±5%

 Automatic pressure pump

 

6

Measurable Wrist Circumference M-sized airbag: 13.0–16.0 cm/5.12–6.30 in

L-sized airbag: 16.1–20.0 cm/6.34–7.87 in

Please select the appropriate airbag according to your

measured wrist circumference.



2020. In the clinical validation study, K5 was used on 85 subjects for determination of diastolic blood

pressure.

For details, call the customer service hotline.

1.4 Structure Diagram and Packing List

Up button

Air inlet and outlet (located where

the body and the strap meet)

Down button (including the electrode)

Airbag

Strap

Cover button

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

the label on the package.

Packing list:

 Device (with an L-sized strap

and an L-sized airbag) x 1  M-sized airbag x 1  M-sized strap (without the clasp) x 1

 Independent cover x 1  L-sized and M-sized airbag

clothings (spare) x 1

 Wrist circumference ruler x 1

 Quick Start Guide x 1  Wearing Guide x 1  Charging cradle (with the power

cable) x 1

 Warranty Card x 1

2. 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.

8

2.3 Measurement Requirements

Any blood

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 mea-

surement is complete. Do not perform the measurement when you feel emotional or stressed.

 

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.

2.2 Working Environment

Network Environment Bluetooth 4.2 or later

Temperature 5°C to 40°C

Humidity 10% RH to 95% RH (excluding condensation)

Atmospheric pressure 80 kPa to 105 kPa

Precautions

 Keep the device away from electromagnetic interference, vibration, and noise.

 



9

Measurement posture:

Keep the watch at

the same height

as your heart

Keep quiet and

avoid talking



the ground without

crossing them

Do not

press the

airbag

Support the elbow

Keep your

wrist and palm

stretched natu-

rally

Sit stably

and relax

your body





10

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.

For details about precautions, operation instructions, maintenance, calibration, and FAQs, see the

user guide in the Huawei Health app.

Description of GUI abbreviations

No. Abbreviation Full Name

1 SYS 

2 DIA 

3 cm centimeter

4 in inch

3. 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.

11

 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.

-

-

peratures.

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 con-

nected 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.

12

4. Explanations of Symbols and Figures

Figures and Symbols Description

Type BF Applied Part

Notice. Indicates caution should be taken because random documents

are referred to.

IP68 Degree of protection of the enclosure

Main chip trademark

Indicates that the product is capable of being recycled.



Forest Stewardship Council

Recycle the object when it is discarded.

Non-ionizing radiation

CE mark

13

The operation guide must be read.

Medical device



Manufacturer

Remove the packaging and dispose of it in the appropriate recycling bin

according to local laws and regulations.

The range of temperature to which the medical device can be safely

exposed.

The range of humidity to which the medical device can be safely ex-

posed.

The range of atmospheric pressure to which the medical device can be

safely exposed.

5. 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.

14

TNSTI-

TUTE ANY KIND 

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 C

rks, 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 oyour mobile phone or wireless device when in a blasting area or in areas posted

 “two-way radios” or “electronic devices” to avoid interfering with blasting operations.

Petrol stations and explosive atmospheres

-

less 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 stor-

age facilities, areas where the air contains chemicals or particles, such as grain, dust, or

metal powders.

Operation and safety

 Using an unapproved or incompatible power adapter, charger or battery may 

explosion or other hazards.

 Ideal temperatures are 5°C to 40°C.

15

 Avoid placing metal objects on the surface of the wireless charging cradle, as they could



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 oc-

curs, 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.

 

care facilities. These requests are designed to prevent possible interference with sensi-

tive medical equipment.

 Som-

sult 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 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.

 rve local laws and regulations while using the device. To reduce the risk of acci-

dents, 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,



 Do not use, stored (in

16

a gas station, oil depot, or chemical plant, for example). Using your device in these envi-

ronments increases the risk of 

 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

explosion, or other hazards.

 The device has undergone testing and has demonstrated water resistance in certain en-

vironments.

 The device has a built-in, non-removable battery. Do not attempt to remove the battery,

otherwise the device may be damaged.

 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

h with clean water and consult a doctor.

 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.

 Unplug the charger from electrical outlets and the device when not in use.

 Do not place sharp metal objects, such as pins, near the microphone. The microphone

may attract these objects and result in injury.

 

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.

 Swit



17

to boarding an aircraft.

 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.

 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.

Disposal and recycling information

The crossed-out wheeled-bin symbol on your product, battery, literature or pack-

aging reminds you that all electronic products and batteries must be taken to sep-

ey must not be

disposed of in the normal waste stream with household garbage. It is the respon-

sibility 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 pro-

tects 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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 equip-

18

ment, such as EU REACH, RoHS and Batteries (where included) regulations, etc. For dec-

larations of conformity about REACH and RoHS, please visit our website



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 compli-

ance 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://consume

This device may be operated in all member states of the EU.

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 avail-

able 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



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

19

applicable to this radio equipment are as follows: MLY-B10/MLY-B11: Bluetooth: 12 dBm,

: , 119

kHz~135 kHz: 66 descending 10 dB/dec above 0., 140 kHz-148.5 kHz:

.

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 releas-

ter the product has been released. All software versions released by the manufacturer have



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 (Dec-



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

screen.

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