Wellue BP2 Automatic Upper Arm Blood Pressure Monitor User Manual

Automatic Upper Arm Blood Pressure Monitor
Model: BP2
User Manual

The Basics

This manual contains the instructions necessary to operate the product safely and in accordance with its function and intended use. Observing this manual is a prerequisite for proper product performance and correct operations, which ensures patient and operator safety.

**** Safety

Warnings and Tips

• Before using the device, please ensure that you have read this manual thoroughly and fully understand the corresponding precautions and risks.
• This device has been designed for practical use but is not a substitute for visiting the doctor.
• The data and results displayed on the device are for reference only and cannot be directly used for diagnostic interpretation or treatment.
• We recommend not using this device if you have a pacemaker or other implanted devices.
• Follow your doctor’s advice, if applicable.
• Do not use this device with a defibrillator.
• Do not use this device during an MRI exam.
• Do not use the device in a combustible environment (i.e., oxygen-enriched environment).
• Never submerge the device in water or other liquids.
• Do not clean the device with acetone or other volatile solutions.
• Do not drop this device or subject it to strong impacts.
• Do not place this device in pressure vessels or gas sterilization devices.
• Do not dismantle the device because this could cause damage or malfunctions or impede device operations.
• This device is not intended for use by people (including children) with restricted physical, sensory, or mental acumen or a lack of experience and/or a lack of knowledge unless they are supervised by someone responsible for their safety, or they receive instructions from this person on how to use the device.
• Children should be supervised around the device to ensure they do not play with it.
• Do not allow the electrodes to come into contact with other conductive parts (including the ground).
• Do not use the device on anyone with sensitive skin or allergies.
• Do not store the device in the following locations: locations in which the device is exposed to direct sunlight, high temperatures or levels of moisture, or heavy contamination; locations near sources of water or fire; or locations that are subject to strong electromagnetic influences.
• Do not swing the device with the strap, which may result in injury. This device displays changes in heartbeat, blood oxygenation, etc. which may have varying causes.
• These may be harmless, but may also be triggered by illnesses or diseases of differing degrees of severity.
• Please consult a medical specialist if you believe you may have an illness or disease.
• Vital sign measurements, such as those taken with this device, cannot identify all diseases.
• Regardless of the measurements taken using this device, you should consult your doctor immediately if you experience symptoms that could indicate a serious disease.
• Do not self-diagnose or self-medicate based on this device without consulting your doctor. In particular, do not start taking any new medication or change the type and/or dosage of any existing medication without prior approval.
• This device is not a substitute for a medical examination for your heart or other organ functions, or for medical electrocardiogram recordings, which require more complex measurements.
• It is not possible to use this device to diagnose illnesses or diseases.
• This is exclusively the responsibility of your doctor. We recommend that you record the ECG curves and other measurements and provide them to your doctor if required.
• Clean the device and cuffs with a dry, soft cloth or a cloth moistened with water and a neutral detergent. Never use alcohol, benzene, thinners, or other harsh chemicals to clean the device or cuffs. Avoid tightly folding the cuffs or wrapping the hoses for long periods, to avoid shortening the component use period.
• The device and cuffs are not water-resistant. Keep rain, sweat, and water from getting on the device and cuffs.
• Measurements may be distorted if the device is used close to televisions, microwave ovens, mobiles phones, X-rays, or other devices with strong electrical fields.
• Do not modify the device. It may cause damage to the device.
• To measure blood pressure, the arm must be squeezed by the cuff hard enough to temporarily stop blood flow through the artery. This may cause pain, numbness, or a temporary red mark on the arm. This condition will appear especially when measurements are repeatedly taken. Any pain, numbness, or red marks will disappear with time.
• Do not apply the cuff on an arm with another electronic medical device. The equipment may not function properly.
• People who have a severe circulatory deficiency in their arm must consult a doctor before using the device, to avoid medical problems.
• Do not self-diagnose the measurement results and start treatment on your own. Always consult your doctor to evaluate the results and subsequent treatment.
• Do not apply the cuff on an arm with an unhealed wound.
• Do not apply the cuff on an arm receiving an intravenous drip or blood transfusion. It may cause injury or accidents.
• Do not use the device where flammable gases, such as anesthetic gases are present. It may cause an explosion.
• Do not use the device in highly concentrated oxygen environments, such as a high-pressure oxygen chamber or an oxygen tent. It may cause a fire or explosion.

Introduction

2.1 Intended Use
The product is intended to be used for measuring, displaying, reviewing, and storing ECG and blood pressure variations in the home or healthcare facilities. ECG and Blood pressure variation is intended for use with adult. The data and results provided by this device are for precheck screening purposes only and cannot be directly used for diagnosis or treatments.
2.2 Contraindications

• This device is contraindicated for use in ambulatory environments.
• This device is contraindicated for use on aircraft.

2.3 About the Product

1. Start/Stop button
   Power On/Off
   Press to Start/Stop measuring blood pressure.

2. Function button
   Press to start the ECG measurement.
   Press and hold for 2 seconds to review historical data.

3. Display screen

4. LED indicator
   The blue light is on: the battery is charging.
   The blue light is off: the battery is fully charged.

5. ECG electrodes Press and hold them while taking ECG measurements.

6. Cable connector
   Connect with the charging cable.

2.4 Unpacking
Main Unit; Charging Cable; User Manual; Quick Guide

2.5 Symbols

municipal waste.
| Follow Instructions for Use.
**| Type BF Applied Part
---|---
| No alarm system
| MRI unsafe. Presents hazards in all MR environments as the device contains strongly ferromagnetic materials.
IP22| Resistant to liquid ingress
0197| CE marking
| Authorized Representative in the European community
| UKCA marking
| Authorized Representative in the United Kingdom
| This product complies with the rules and regulations of the Federal Communication
Commission.
| Non-ionizing radiation
| Heartbeat symbol
| Battery symbol
| Bluetooth symbol
| Data transmission symbol
| Successfully uploaded to the cloud
| ECG waveform
| ECG measurement progress bar
NEXT| Press to display next record
HOME| Press to return to the home screen
13/50| Current record / Total records
POOR SIGNAL| Lead off when ECG is measuring
Cheak connection| Leadoff when ECG is measuring
Regular ECG| The recorded ECG satisfies a common regular pattern.
Irregular ECG**| The recorded ECG is erratic. It may be caused by heart issues or other conditions.

Using the Monitor

3.1 Charging the Battery
Use the USB cable to charge the monitor. Connect the USB cable to a USB charger or to the PC. It takes 2 hours to fully charge. When the battery is fully charged, the indicator will be off.
The monitor works on very low power consumption, and a full charge usually lasts for months. A battery symbol, which indicates the battery status is displayed on the screen.
Note: The device cannot be used while charging.
3.2 Blood Pressure Measurement
3.2.1 Before Taking Measurements
To help ensure accurate measurements, follow these directions:

• Rest for at least 5 minutes before taking measurements. Stress raises blood pressure.
• Avoid taking measurements when stressed.
• Remove any tight-fitting clothing from your arm.
• A single measurement does not provide an accurate indication of your true blood pressure.
• You need to take and record several results over a period of time.
• Try to measure your blood pressure at the same time each day to maintain consistency.

3.2.2 Applying the Arm Cuff

1. Wrap the cuff around the upper arm, about 1 to 2 cm above the elbow joint, as shown.
2. Place the cuff directly against the skin, as clothing may cause a faint pulse and result in measurement errors.
3. Constriction of the upper arm, caused by rolling up a shirtsleeve, may prevent accurate readings.
4. Confirm that the artery position mark is lined up with the artery.

Note keep the host wear position aligned with the middle finger.

3.2.3 Sitting Correctly
To take measurements, you need to be relaxed and comfortably seated. Sit in a chair with your legs uncrossed and your feet flat on the floor. Place your arm on a table, so that the cuff is level with your heart. 3.2.4 Measuring Blood Pressu re

1. Power on the blood pressure monitor.
2. Press the Start/Stop button to start taking blood pressure measurements.
3. The monitor will automatically deflate the cuff slowly while taking measurements. A typical measurement takes about 30s.
4. The readings will be displayed when the measurement is finished. 11

You can press Start/Stop button again to stop the blood pressure measurement.
Note: While taking measurements, you should remain still and not squeeze the cuff.
3.2.5 After Taking Measurements
The monitor will automatically release the gas in the cuff once finished taking measurements. Press the button to turn the power off after taking measurements. Remove the cuff.
Note: The device has an automatic power shut-off function, which turns off the power automatically 2 minutes after taking measurements.
3.3 Recording ECG
3.3.1 Before Taking Measurements
To help ensure accurate measurements, follow these directions:

• Before using the ECG function, pay attention to the following points to obtain precise measurements.
• The ECG electrode must be positioned directly against the skin.
• If your skin or hands are dry, moisten them using a damp cloth before taking measurements.
• If the ECG electrodes are dirty, remove the dirt using a soft cloth or cotton swab dampened with disinfection alcohol.
• While taking measurements, do not touch your body with the hand with which you are taking measurements.
• Please note that there must be no skin-to-skin contact between your right and left hand. Otherwise, the measurements cannot be taken correctly.
• Stay still while taking measurements, do not speak, and hold the device still.
• Movements of any kind will falsify measurements.
• If possible, take measurements when sitting and not when standing.
• Follow the text and voice guides on your phone to finish taking measurements.

3.3.2. Recording ECG without the Cable
There are four methods to record ECG without the cable.

A.Right hand to left Leg|
---|---
B.Hand to hand|
C.Right hand to abdomen|
 D.Right hand to chest|

To start an ECG Recording:

1. Put your right palm on the right side electrodes of the monitor.
2. Place the left side electrodes to the body position that you desired to measure.
3. Once the body parts are placed on the electrodes, press the Function button to start EKG recording.
4. Wait for 30 seconds, the result readings will be displayed.

To start recording ECG again, press the Start/Stop button to return to the Home screen, then press the Function button.
Note:
The recording must take at least 30 seconds to complete and to be analyzed by the detectors
You can get different signal amplitudes from different methods. Use Lead II mode if the signal is too low in Lead I mode.
3.3.3. Turn on/off Heartbeat Sound
The buzzer beeps when a heartbeat is detected while recording ECG. You can turn on/off the heartbeat sound on the App.
3.4 Reviewing History Records
You can review the history results and replay the recorded ECG waveform on the History screen. Hold the Function button for 2 seconds to enter the History screen. The last measurement results will be displayed by default

For ECG recordings, the Heart Rate will be displayed first and then replayed over the 30-second ECG waveform.
To view the next records, press the NEXT button. To exit the History screen, press the HOME button.
3.5 Using the App
App name: VicHealth iOS: App Store Android: Google Play
The monitor has built-in Bluetooth wireless connectivity, which enables exporting measurement records to mobile phones and tablets running iOS or Android. Hold the function button and Start/Stop button simultaneously to enable Bluetooth and start pairing it to your smart device.
3.5.1 Connect the monitor with Wi-Fi network
You can connect the device to the Wi-Fi network in the App. See the quick guide for details.
3.5.2 Data transmission
After the device is connected to the Wi-Fi network, the measurement results will be automatically uploaded to the cloud.
You can download and view historical data in the App at any time, regardless of whether the device is connected to the App

Troubleshooting

battery
Blood pressure readings appear too high or too low| Blood pressure varies constantly. Many factors including stress, time of day, and/or how you apply the arm cuff may affect your
blood pressure.| Hold still for a moment and t try again
Error 1
Apply the arm cuff tighter.| Arm cuff is applied too loosely| Tighten the arm cuff and try again.
Error 2
Do not move or talk, remain
still.| Moving or talking while taking measurements, and the pressure of the cuff is interfered with.| Remain still and do not talk while taking
measurements
Error 3 Remove any clothing
interfering with the cuff.| The signal is poor while measuring blood pressure.| Take blood pressure on a bare arm.
Error x (x>4) Contact customer
service.| The device has malfunctioned.| Contact customer service.
Check the connection| The ECG cable is off, or the body parts are not placed on the electrodes closely enough.| Check the ECG cable, or place the electrodes closer to your body part.
ECG waveform drifts| The pressure exerted on the electrode is not stable or too much.| Hold the device stably and gently.
| The hand or body may be moving.| Try to keep perfectly still and test again.
---|---|---
The ECG waveform amplitude is small| The measurement method you chose is not suitable for you.| Change another lead and try
again.

Maitenance

5.1 Maintenance
To protect your monitor from damage, store the monitor and the components in a clean, safe location. Caution: DO NOT disassemble or attempt to repair this monitor or other components. This may cause inaccurate blood pressure readings and/or EKG recordings.
5.2 Cleaning

• Do not use any abrasive or volatile cleaners.
• Use a soft dry cloth or a soft cloth moistened with mild (neutral) detergent to clean your monitor and the arm cuff and then wipe them with a dry cloth.
• When electrodes are dirty, use a soft cloth or cotton swab moistened with an alcohol-based sanitizer to clean the electrodes.
• Do not use gasoline, thinners, or similar solvents to clean your monitor and arm cuff or other components.

5.3 Storage

• Keep your monitor and other components in the storage case when not in use.
• Store your monitor and other components in a clean, safe location.
• Do not store your monitor and other components in locations exposed to extreme temperatures, humidity, direct sunlight, dust, or corrosive vapors, such as bleach.

Specifications

Classifications

EC Directive| MDD, 93/42/EEC
RED, 2014/53/EU
ROHS 2.0, 2011/65/EU
Degree of protection against electrical shock| Type BF
Environmental
Item| Operating| Storage
Temperature| 5 to 40°C| -25 to 70°C
Relative humidity
(non-condensing)| 10% to 95%| 10% to 95%
Barometric| 700 to 1060 hPa| 700 to 1060 hPa
Degree of dust & water resistance| IP22
Drop test| 1.0 m
Physical
Size (main unit)| 135mm(L)x45mm(W)x20mm(H)
Weight (main unit)| 240 g
Cuff size| Adult cuff: 22-42cm
Small adult cuff (optional): 17-22cm Adult cuff (optional): 22-32cm
---|---
Wireless connectivity| Built-in Bluetooth 4.0 BLE
Power Supply
Charge input| Micro USB, DCSV
Battery type| Rechargeable lithium-polymer battery
Battery run time| 500 measurements
Charge time| 2 hours
Blood Pressure Measurements
Technology| Oscillometric Method
Pressure measurement range| 0 – 300mmHg
Pressure measurement accuracy| ±3mmHg
Pulse rate range| 40 to 200 /min
Pulse rate accuracy| ±2 /min
Clinical accuracy| Meet IEC80601-2-30
ECG Recording
Lead type| Integrated ECG electrodes
Lead set| Lead I, Lead II, Chest Lead
ECG length| 30s
Heart rate range| 30 – 250/min
Heart rate accuracy| ±2 /min or ±2%, whichever is greater
Storage
Blood pressure records 150
ECG records| 10
---|---
Bluetooth RF
Frequency range| 2.402 — 2.480 GHz
Max RF power| -10 dBm

Electromagnetic Compatibility

The device meets the requirements of EN 60601-1-2.
Warnings and Tips

• Using accessories other than those specified in this manual may result in increased electromagnetic emissions or decreased electromagnetic immunity for the device.
• The device or its components should not be used adjacent to or stacked with other equipment.
• The device needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided below.
• Other devices may interfere with this device even though they meet CISPR requirements.
• When the inputted signal is below the minimum amplitude provided in the technical specifications, erroneous measurements could result.
• Portable and mobile communication equipment may affect device performance.
• Other devices that have RF transmitters or sources may affect this device (e.g. cell phones, PDAs, and PCs with wireless functionality). The EMC table information is listed on our website: http://api.viatomtech.com.cn/documents/2017/emc_en.pdf

PN255-04359-00
Version: Sept. 2021
Shenzhen Viatom Technology Co., Ltd.
4E, Building 3, Tingwei Industrial Park, No.6 Liufang Road, Block 67,
Xin’an Street, Baoan District, Shenzhen, 518101, Guangdong, China
Well Kang Limited
The Black Church, St. Mary’s Place, Dublin 7, D07 P4AX, Ireland
Tel 1: +353(1)2542900
Tel 2: +353 (1)4433560
Fax: +353(1)6864856
Email:AR@Well-Kang.com
Wellkang Ltd (www.UKCA-marking.com)
16 Castle St., Dover, CT16 1PW, England
Tel 1: +353(1)2542900
Tel 2: +353 (1)4433560
Fax: +353(1)6864856
Email:AR@Well-Kang.com

References

• ecrep.com
• Que Faire de mes Déchets ? Découvrez les solutions pour tous vos déchets et nos conseils pour en produire moins.

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