HUAWEI MLY-B10 WATCH D User Manual
Quick Start Guide
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]
- 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.
- 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 the patient moving, trembling, or shivering may affect the blood pressure measurement reading.
- Measurements may be inaccurate for patients suffering from blood circulation disorders and blood diseases.
- Do not use this monitor on infants, toddlers, children, or persons who cannot express themselves.
- This device has not been validated for use on pregnant patients.
- Consult with your physician before using this device if you have had a mastectomy.
- The following should be used for blood pressure measurements under the guidelines. Safe Use Quick Start Guide 2 ance 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.
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 anti-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.
Product Information
Intended Use
The Wrist Blood Pressure Monitor is a digital monitor intended for use in measuring blood pressure and pulse rate in an adult patient population with wrist circumference ranging from 13.0 to 20.0cm (5.12-7.87 inches).
Contraindications
Allergic reactions to this product.
Performance Indicators
| General Specifications | |
| 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- esthetic Gas Mixed with Air, Oxygen, or Nitrous Oxide | Non-AP/APG type |
| Running Mode | Continuous running |
| Power Supply | Rechargeable Li-ion Polymer Battery (Rated capacity: 451 mAh/1.74 Wh; rated voltage: 3.87 V) |
| Battery Life Information | Typical usage: 7 days Typical application scenario: default settings; heart rate monitoring: always on; TruSleepTM: on at night; blood pressure measurement: 6 times per day; ECG measure- ment: 5 times per day; average weekly exercise: 90 min- utes; message notifications: enabled (with 50 messages, 6 incoming calls, and 3 alarms per day); screen-on: 200 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) | Device body: 3 years; airbag & strap: 1 year; airbag clothings (spare): 0.5 years |
Blood Pressure Measurement | |
| Measuring Method | Oscillometric 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% |
| Inflation Method | Automatic pressure pump |
| Deflation Method | Automatic fast deflation |
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
- 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
Blood Pressure Measurement
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.
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.
- 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.
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 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
| No. | Abbreviation | Full Name |
| 1 | SYS | SYSTOLIC BLOOD PRESSURE |
| 2 | DIA | DIASTOLIC BLOOD PRESSURE |
| 3 | cm | centimeter |
| 4 | in | inch |
For details about precautions, operation instructions, maintenance, calibration, and FAQs, see the user guide in the Huawei Health app.
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.
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.
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.
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, products, services, and company names mentioned may be the property of their respective owners.
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, and 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 cause fire, explosion, or other hazards.
- Ideal 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 the 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 healthcare facilities. These requests are designed to prevent possible interference with sensitive medical equipment.
- 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 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.
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 help 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 to 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/.
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.
