MedM B103W BPM Mobile App User Guide

ADF-B103W
Wrist Electronic
Blood Pressure Monitor
Model: U62I

Introduction

▲ Thank you for purchasing the Wrist Blood Pressure Monitor. Please read the manual carefully before you use the unit, and keep the manual well after using.
▲ The unit is compact and easy to use, adopts the oscillometric principle. It measures your blood pressure advanced ” Intellisense” for comfortable controlled inflation without the need of pressure presetting or reinflation. This unit is only applied for the adult reinflation. This unit is only applied for the adult
▲ 2×90 sets memory function, each measurement result will be displayed on the screen, and automatically stored.This unit has blood classification index, could easy to check your classification index, could easy to check your blood pressure.

INTENDED USE
The automatic blood pressure monitor intends to measure the systolic pressure, diastolic pressure and pulse rate through wrist. It’s expected to be used at home or in the hospital, intended for people over 12 years old.

CONTRAINDICATION
This product can’t be used in patients who is with severe heart insufficiency to avoid suffocation and death. This product is not suitable for infants and children.

Safety Information

To assure the correct use of the product, basic safety measures should always be followed including the warning and the caution listed in the instruction manual:

Symbol descriptions

The following symbols may appear in this manual, on the label, on the device, or on it’s accessories. Some of the symbols represent standards and compliances associated with the device and its use.
WARNING: This alert identifies hazards that may cause serious personal injury or death.
CAUTION: This alert identifies hazards that may cause minor personal injury, product damage, or property damage.

| Type BF applied part
---|---
| Manufacturer
SN| Specifies serial number
| Authorized Representative in the European Community
| CE Mark: conforms to essential requirements of the Medical
Device Directive 93/42/EEC.
| DISPOSAL: Do not dispose this product as unsorted municipal waste. Collection of such waste separately for special treatment
is necessary.
| Direct current
| Follow instructions for use
| CAUTION: Consult accompanying documents

Those who have arrhythmia, diabetes, blood circulation or apoplexy problem, please use under the physician’ s instruction.
Contact your physician for specific information about your blood pressure. Self diagnosis and treatment which use measured results may be dangerous. Follow the instructions of your physician or licensed healthcare provider.
Please placeon a high place where children can’t be touched.
No modification of this equipment is allowed.
Do not modify this equipment without authorization of the manufacturer.
If this equipment is modified, appropriate inspection and testing must be conducted to ensure continued safe use of equipment.
The cuff hose around neck may cause the suffocation.
The swallowing of small part like packaging bag, battery, battery cover and so on may cause the suffocation.
Please don’t use a dilution agent, alcohol or petrol to clean from a high place. Use the right cuff, otherwise it can not Never leave any low battery in the battery compartment work.
Never leave any low battery in the battery compartment since they may leak and cause damage to the unit.
Please take off the battery if you won’t use in 3 months
Replace the new batteries if the unit display a low battery symbol.
Do not mix the old and new batteries.
Do not use a cellular phone near the unit. It may result in operational failure.
Please avoid using in high radiant area in order to make your measur ing data correctly.
Do not use the equipment where flammable gas (such as anesthetic gas, oxygen or hydrogen) or flammable liquid (such as alcohol) are present.

WARNING:
Do not dispose of electrical appliances as unsorted municipal mm waste, use separate collection facillities.Contact you local government for information regarding the collection systems available. If electrical appliances are disposed of in landfills or dumps, hazardous substances can leak into the groundwater and get into the food chain, damaging your health and well-being.

Classification

1. Internally powered equipment;
2. Type BF applied part; .
3. Protection against ingress of water or Particulate matter: 1P21;
4. Not category AP /APG equipment;
5. Mode of operation:intermittent operation.

The user must check that the equipment functions safely and see that it is in proper working condition before being used.

Product Structure

UNIT

① LCD Display
② Start/Stop Button
③ SET Button| ④ Memory Button
⑤ Battery Cover
⑥ CUFF
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DISPLAY

Each Of Component

NOTE:
Please read the warranty information in the end of the manual carefully.

Battery installation

Battery Installation And Replacement

1. Push the hook on the bottom of the battery cover as picture.

2. Insert two 1.5V “AAA” batteries in the battery compartment.
   Place the batteries “+” and “-” in the right in the right.

3. Pull the battery cover to the main unit.
   When the battery cover close tightly, could hear “Ka-ka”.

Low battery and replacement
When power on, the low battery symbold will display once the unit start to work, and you must replace with new batteries, otherwise the unit can’t work.

Battery type and replacement
Please use 2pcs AAA identical 1. 5V alkaline batteries.
Do not use the batteries beyond their expiry date.
Please remove the batteries if you do not need to use for long time.

WARNING
Dispose of the battery in accordance with all federal, state and local laws.
To avoid fire and explosion hazard, do not burn or incinerate the battery.

Setting Mode

HOW TO SET USER
Press button MEM when power off, the screen will display or , press button MEM , it will be changed between and , press button SET when you confirm the user, then it will enter into the Year Setting mode.

YEAR SETTING
Continue to above step, the screen will display and flash 20XX, the last digit of the year will increase 1 when press button MEM each time, you could choose from 2020 to 2099. Press button SET when you confirm the year, then it will enter into the Month and Date Setting mode.

MONTH AND DATE SETTING
Continue to above step, the screen will display xMxxD and XX-XX,and keep flashing on month ,the digit will increase 1 when press button MEM each time , you could choose from 1 to 12.Press button SET when you confirm the month, then it will set the date.
Same as the month setting ,each time you press button MEM ,the digit will keep changing from 01 to 31.Press button SET when you confirm the date, then it will enter into the Time Setting mode.

TIME SETTING
Continue to above step, the screen will display xXMxxD and XX:XX, and keep flashing on the digits of hour, the digit will increase 1 when press button MEM each time, you could choose from 0 to 23.Press button SET when you confirm the hour, then the digits of minute start to flash, same as the hour setting, each time you press button MEM, the digits will keep changing from 00 to 59. Press button SET when you confirm the minute, then the total setting is completed.

Note:
If the battery has been retracted for 30s and continues to extend, you need to set the date and time

Properuse Of The Unit

Measurement
Pre-measurement
Relax for about five to ten minutes prior to the measurement Avoid eating, drinking alcohol, smoking, exercising and bathing for 30 minutes before taking a measurement. Alll these factors will influence the measurement result.
Remove any garment that fits closely to your wrist.
Always measure on the same wrist (normally left).
Take measurement regularly at the same time of every day, as blood pressure changes even during the day.

Common factors of wrong
All efforts by the patient to support their arm can increase All efforts by the patient to support their arm can increase.
Make sure you are in a comfortable ,relax position and do not activate any of the muscles in the measurement arm during measurement.Use a cushion for support if necessary.
If put the wrist lower or higher than the heart, a false reading will be obtained.

Note:
Only use clinically approved cuffs!
Aloose cuff or a exposed bladder causes false reading.
With repeated measurements , blood accumulates in the arm which can lead to false reading.
Consecutive blood pressure measurements should be repeated after 1 minute pause or after the arm has been held up in order to allow the accumulated blood to flow away.

1. Roll up sleeve. Make sure your sleeve is not rolled up too tightly on your arm. This may constrict the flow of blood in your arm.
2. Wrap the cuff directly against your skin,hold the bottom part of the cuff and wrap it around the wrist so it fits comfortably and securely around your wrist as picture show.
3. Sit in a chair and take an erect body posture, make the erect body posture, make the monitor at the same level as your heart.
4. Press the START/ STOP button, the monitor will measure your blood pressure automatically, Please keep still when the monitor works.
5. Connect iOS/Android device via Bluetooth (Turn Bluetooth “On” under the “Settings” menu on the iOS device).
6. Open “Andesfit health” application, and then press the icon on Measurement screen

Note:
If it is not possible to fit the cuff to your left wrist, it can also be placed on the right. However, all measurements should be made using the same wrist.

1. Press the START/STOP button, all symbols appear on the display. then 0 flash for 2 seconds, the pump begins to inflate the cuff, the rising pressure in the cuff is shown on the display.
2. After the suitable pressure has been reached, the pump stops and the pressure gradually falls, The cuff pressure is displayed, In case that the inflation is not sufficient, the device automatically re-inflates to a higher pressure.
3. When the device detects a pulse, the heart symbol on the display starts to flash.
4. When the measurement has been completed, the systolic, diastolic and pulse rate will appear on the display.
5. The measurement readings remain on the display until you switch off the device. If no button is pressed for a period of 1 minutes, the device switches off itself in order to save the power.

NOTE:
The symbol will be displayed along with the reading if the irregular heartbeat is detected during the measurement.
Discontinuing a measurement
If it i necessary to interrupt 3 blood pressure measurement far any reason (eg.the patient feels unwell) the START/STOP button can be pressed at any time, The device immediatety decrease the cuff pressure automatically.
Memory-recall of measurements
This blood pressure monitor automabcally stores 2×90 sets measurements value, the oldest record will be replaced by the latest measurement value when move than 90 sets each user
Read memory record
Press the MEM button when power off, the latest 1 times average value will be shown, peess the MEM button again, the last measurement value will be shown, 2s well as subsequent measurements can be display one after the other by pressing the MEM button each time.

Memory -clear of measurements
If you are sure that you want to permanently remove all stored memories. Press the SET button for 7 times until CL appears when power off, press the START/STOP button, CL will flash for 3 times to clear all the memories. After this press the MEM button again, and “no” will be shown on the display which mean that no memory in store.

About Blood Pressure

About Blood Pressure
Blood pressure is the pressure exerted the arteries.
The systolic blood pressure value represents the blood pressure produced by contraction of the heart muscle.
The diastolic blood pressure value represents the blood pressure produced by relaxation of the heart muscle.◼According to the blood pressure classification by the WHO/ISH.
◼ SYS lower than 100mmHg is considered as hypotension. Blood Pressure Type

Exceptional Situation

Error indicators
The following symbol! will appear on the display when measuring abnormal.

Remeasure with correct way.
| External strong disturbance| When near cell phone or other high radiant device the measurement will be failed,
Keep quite and no chatting when measure.
| It appears error during the process of inflating| Wrap the cuff properly.
Make sure that the air plug is property inserted in the unit.
Remeasure
| Abnormal blood pressure| Repeat the measurement after relax for 30 mins, if get unusual readings for 3 times, please contact your doctor.
| low battery| Replace all the worn batteries with new ones.

Exceptional Situation
Trouble removal

batteries polarities
Err and stop working| Whether move the wrist when inflate| Keep the body peaceful
Check if chatting when measured| Keep quite when measure
Cuff leak| Whether the cuff wrap too loose| Wrap the cuff tightly
Whether the cuff broken| Change a new cuff
Please contact the distributor if you can’t solve the problem, do not disassemble the unit by yourself!

Care and maintenance

Keep the unit in the storage case when no use.
Clean the unit with soft dry cloth.
Do not use any abrasive or volatile cleaners.
Never immerse the unit or any component in water. ※ We won’t be responsible for any quality problem if you don’t care and maintain the product as instructed.
Make sure the monitor is off prior to cleaning,a mixture of distilled water and 10 percent bleach could be used.
Using a spray bottle, moisten a soft cloth towel with the bleach or detergent mix until it is fully saturated. Squeeze any excess moisture from the cloth to avoid any dripping or potential oversaturation of the cuff.
Wipe all surfaces of the blood pressure monitor cuff thoroughly, making sure to clean the inside and outside of the cuff. Be cautious not to get any moisture in the main unit.
Using a dry cloth, gently wipe away any excess moisture that may remain on the blood pressure cuff. Lay the cuff flat in an unrolled position and allow the cuff to air dry.

Maintenace

Do not clean the body and cuff with naphtha, thinner or gasoline etc.| Do not wet the cuff or attempt to clean the cuff with water.
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|
Store the unit in a clean and dry location.
Do not subject the unit to extreme hot or cold temperature, humidity and direct sunlight.| Remove the batteries if the unit will not be used in 3 months or longer.
|
※ We won’ t be responsible for any quality problem if you don’t care and maintain the product as instructed.

Specification

crash, sun burn or rainduring transportation.
Cuff size| Wrist circumference approx. Size 13.5~21 .5cm

Warranty Information

Statement
The intended use: the unit is intended to be used by adults at home or medical center to measure blood pressure and pulse rate from the wrist.
The unit satisfies the requirements of EN ISO 81060-1 Part 1 Noninvasive sphygmomanometers, EN 1060-3:1997+ A2:2009 Non-invasive sphygmomanometers. IEC80601-2-30 Part 2 Non-invasive spohygmomanometers.
Blood pressure measurements determined with this device are equivalent to those obtained by a trained observer using the cuff/ stethoscope auscultatory method, within the limits prescribed by the American National Standard, manual,electronic, or automated spohygmomanometers.
The risk of patient and user can be lowered to acceptable level.
Warranty Information
The unit is guaranteed to be free of defects in workmanship and materials under normal use for a period of One Year from the date listed on the purchase record.
For repair under this warranty. Our authorized service agent must be advised of the fault with the period of the warranty. This warranty covers parts and labor only under normal operations. Any defect resulting from natural causes, eg. flood,hurricane etc, is not within this guarantee. This guaranty does not cover damage incurred By use of the unit not in accordance with the instructions,accidental damage,or being tampered with or serviced by unauthorized service agents.
Monitor subjected to misuse,abuse, and neglect of these manual content,non-in structional purposes;unauthorized repair or modifications will be excluded from this warranty.
The device requires no calibration.
The device is not repairable and contains no user serviceable parts.

EMC Declaration

IEC 60601-1-2: 2014 ME EQUIPMENT and ME SYSTEMS identification, marking and documents for Class B product
Instructions for use
The ME EQUIPMENT or ME SYSTEM is suitable for home healthcare environments and so on.
Warning: Don’t near active HF surgical equipment and the RF shielded room of an ME system for magnetic resonance imaging, where the intensity of EM disturbances is high.
Warning: Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.
Warning: Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.”
Warning: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the blood pressure monitor, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
If any: A list of all cables and maximum lengths of cables (if applicable), transducers and other ACCESSORIES that are replaceable by the RESPONSIBLE ORGANIZATION and that are likely to affect compliance of the ME EQUIPMENT or ME SYSTEM  with the requirements of Clause 7 (EMISSIONS) and Clause 8 (IMMUNITY).
ACCESSORIES may be specified either generically (e.g. shielded cable, load impedance) or specifically (e.g. by MANUFACTURER and EQUIPMENT OR TYPE REFERENCE).
If any: The performance of the ME EQUIPMENT or ME SYSTEM that was determined to be ESSENTIAL PERFORMANCE and a description of what the OPERATOR can expect if the ESSENTIAL PERFORMANCE is lost or degraded due to EM DISTURBANCES (the defined term “ESSENTIAL PERFORMANCE” need not be used).
Technical description

1. All necessary instructions for maintaining BASIC SAFETY and ESSENTIAL PERFORMANCE with regard to electromagnetic disturbances for the excepted service life.
2. Guidance and manufacturer’s declaration electromagnetic emissions and Immunity.

Tabe 1

Guidance and manufacturer’s declaration – electromagnetic emissions

Emissions test| Compliance
RF emissions CISPR 11| Group 1
RF emissions CISPR 11| Class B
Harmonic emissions IEC 61000-3-2| Not application
Voltage fluctuations/ flicker emissions IEC 61000-3-3| Not application

Tabe 2

Guidance and manufacturer’s declaration – electromagnetic Immunity

Immunity Test| IEC 60601-1-2 Test level| Compliance level
Electrostatic discharge
(ESD) IEC 61000-4-2| ±8 kV contact
±2 kV, ±4 kV,±8 kV, ±15 kV air| ±8 kV contact
±2 kV, +4 kV,
±8 kV, +15 kV air
Electrical fast transient/burst IEC 61000-4-4| Power supply lines:
±2 kV input/output lines:
±1 kV 100 kHz repetition frequency| Not application
Surge IEC 61000-4-5| line(s} to line(s): ±0.5kV ±1 kV.| Not application
Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11| 0% 0.5 cycle At 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315° 0% 1 cycle And 70% 25/30 cycles Single phase: at 0 0% 300 cycle| Not application
Power frequency magnetic field IEC 61000-4-8| 30 A/m 50H2/60Hz| 30 A/m 50Hz/60Hz
Conduced RF
IEC61000-4-6| 150KHz to 80MHz:
3Vrms
6Vrms (in ISM and amateur radio bands)
80% Am at 1kHz| Not application
Radiated RF
IEC61000-4-3| 10 V/m
80 MHz — 2,7 GHz
80 % AM at 1 kHz| 10 V/m
80 MHz — 2,7 GHz
80 % AM at 1 kHz
NOTE UT is the a.c. mians voltage prior to application of the test level.

Tabe 3

Gidance and manufacturer’s declaration – electromagnetic Immunity

Radiated RF IEC61000-4-3
(Test specifications for ENCLOSURE PORT IMMUNITY to
RF wireless communications equipment)| Test Frequency
(MHz)| Band (MHz)| Service| Modulation| Modulation (W)| Distance (m)| IMMUNITY
TEST LEVEL
(V/m)
385| 380 — 390| TETRA 400| Pulse
modulation
18 Hz| 1,8| 0.3| 27
450| 430 — 470| GMRS 460,
FRS 460| FM
± S kHz
deviation
1 kHz sine| 2| 0.3| 28
710| 704 — 787| LTE Band 13, 17| Pulse modulation
217 Hz| 0.2| 0.3| 9
745
780
810| 800 — 960| GSM 800/900, TETRA 800, iDEN 820, CDMA 850, LTE Band 5| Pulse
modulation
18 Hz| 2| 0.3| 28
870
930
1920| 1700 —1990| GSM 1800;
CDMA 1900;
GSM 1900;
DECT;
LTE Band 1, 3,
4, 25; UMTS| Pulse
modulation
217 Hz| 2| 0.3| 28
1845
1970
2450| 2400 — 2570| Bluetooth,
WLAN,
802.11 b/g/n,
RFID 2450,
LTE Band 7| Pulse
modulation
217 Hz| 2| 0.3| 28
5240| 5100 — 5800| WLAN 802.11
a/n| Pulse
modulation
217 Hz| 0.2| 0.3| 9
5500
5785

AndesFit Itd
Unit 513 Lakeside 1, No.8 Science Park West Ave.,
Hong Kong Science Park, Hong Kong
Customer Services: (852) 35951880
www.andesfit.com
Manufacturer
Shenzhen Urion Technology Co.,Ltd.
Floor 4-6th of Building D, Jiale Science&Technology Industrial Zone, No.3,
ChuangWei Road, Heshuikou Community, MaTian
Street, GuangMing New District, 518106 ShenZhen, PEOPLE’S
REPUBLIC OF CHINA
Tel:(86)-0755-29231308 E-mail: urion@urion.com.cn
MADE IN CHINA
Software version: UA1.0
Expected service life: 5 years

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