Withings Bpm connect User manual

PRODUCT GUIDE

WITHINGS

Box Content

Withings BPM Core

USB charging cable

Quick Start Guide

and product guide

Important notice

Before using Withings BPM Core, review the information in this

guide:

Please contact Withings when in need of assistance, setting up,

using or maintaining the device or to report unexpected oper-

ations or events. The user is an intended operator. Any serious

incident that has occurred in relation to the Withings BPM Core

should be reported to Withings and competent authorities in

your country of residence.

In order to use your Withings BPM Core, you need an iOS (14.0

or higher) or Android (8.0 and higher) device to install it.

Thereafter, the product can be used without your mobile device

on you, thanks to the Wi-Fi and Bluetooth® connections.

2023

WITHINGS,

2 rue Maurice Hartmann,

92130 Issy-les-Moulineaux,

FRANCE

+33141460460

1282

Distributed by Withings

Inc.,

179 South Street, Floor 5

Boston, MA 02111 USA

Intended use

Withings BPM Core is a digital

monitor intended for use in

measuring blood pressure

and heart rate, to record a

one-lead ECG to detect atrial

ﬁbrillation, and to uncover

valvular heart diseases (aortic

stenosis, aortic regurgitation,

mitral regurgitation). The

device is intended to be used

in a human adult population

with an arm circumference of

9 inches to 17 inches (22 cm

to 42 cm). Withings BPM Core

is a medical device. Contact

your physician if hypertensive

values, atrial ﬁbrillation (AFib)

or VHD are indicated.

WELCOME TO THE COMMUNITY

DISCOVER OUR DEVICES

BIENVENUE DANS LA COMMUNAUTÉ | WILLKOMMEN IN DER COMMUNITY

DÉCOUVREZ NOS PRODUITS CONNECTÉS | ENTDECKEN SIE UNSERE GESUNDHEITSGERÄTE

withings.com

WITHINGS | BPM CORE

AW_QSG_HERO_WPM04_INTER_A

V1.0 Sept 2022

Warnings and safety notices

- Do not forcibly bend the arm cu.

- Do not inﬂate the arm cu when it is not wrapped around your arm.

- Do not apply strong shocks and vibrations to the blood pressure

monitor or drop it.

- Do not take a measurement after bathing, drinking alcohol,

smoking, exercising or eating.

- Do not immerse the arm cu in water.

- Do not use with a pacemaker, a deﬁbrillator or other electric

implant.

- Use on adults only.

- Do not use it on children or pets.

Consult your doctor during pregnancy, or if you suer from

arrhythmia and arteriosclerosis. Please read this section carefully

before using this smart blood pressure monitor with ECG & digital

stethoscope.

Always consult your doctor. Self-diagnosis of measurement results

and self treatment are dangerous. People with severe blood ﬂow

problems or blood disorders should consult a doctor before

using the blood pressure monitor. Cu inﬂation can cause internal

bleeding. Operational factors such as common arrhythmias, ven-

tricular premature beats, arteriosclerosis, poor perfusion, diabetes,

age, pregnancy, pre-eclampsia or renal disease can aect the

performance of the automated sphygmomanometer and/or its

blood pressure reading. This is a precision measuring device that

may be understood by lay users, but should still be handled with

care. Exposing the device to prolonged lint, dust or sunlight might

reduce its life or damage it. A damaged cu or sensor may lead

to incorrect measurements. The USB port should only be used for

charging the device. Parts in contact with the skin: cu and elec-

trodes. Measurements can be aected by extreme temperatures,

humidity & altitude.

- Do not leave the blood pressure monitor unattended with infants.

Strangulation may occur.

- Do not use the blood pressure monitor for any purpose other

than measuring blood pressure, recording an ECG and recording

heart sounds.

- Do not disassemble the blood pressure monitor.

- Do not operate the blood pressure monitor in a moving vehicle

(car, airplane).

- Do not use the device with the USB cable plugged in.

- Do not shake the unit violently.

- Improper continuous pressure of cu or too-frequent measure-

ments may interfere with blood ﬂow and result in injury to the

user. Check to ensure that the use of the device does not result in

prolonged impairment of your blood circulation.

- Do not apply the cu over the user’s arm if it has a wound or

medical treatment, as this can cause further injury.

- Consult your physician before using this monitor if you have had

a mastectomy.

Warnings and safety notices

Types of measurements

- Use of the device can temporarily cause the loss of function of

equipment that is used simultaneously on the same limb.

- Do not use if you have a congenital cardiomyopathy, aorto-ve-

nous ﬁstula, pulmonary pathology, a prosthetic heart valve, if you

are on kidney dialysis, or if you are hemodynamically unstable.

- There is a risk concerning Lead, PZT, DEHP, DBP, SCCP and D6

according to REACH regulation 1907/2006.

Withings BPM Core allows you to take two types of measure-

ments:

- Blood pressure and heart rate, which uses the cu as a sensor.

- ECG and Heart Sounds recording, which uses three electrodes

(two inside the cu, the other on the metal tube) and the stetho-

scope (the circular white sensor on the cu).

Before the measurement, make sure that you:

- Choose a calm, quiet room to take the measurement.

- Ensure you have a chair, one with a back, and a table or armrest

on which you can place your arm.

- Use the device on the left upper arm.

- Do not speak or move during the measurement.

- Wear only one layer of clothing, which should not cover your left

arm. The electrodes should be in contact with the skin.

Before the measurement

2 - Tighten the cu around

your arm. The stethoscope

should be facing the rib

cage, with the metal tube

facing down about one inch

above the elbow.

How to take measurements

1 - Sit down in a comfortable

position, legs uncrossed,

feet ﬂat on the ﬂoor, arm

and back supported.

Uncover your left arm. Rest

for 5 minutes before the ﬁrst

measurement.

How to take measurements

3 - For blood pressure measurement. Place your left arm on a

table with the cu level with your heart and your palm facing

up. Make sure the cu is not touching the left side of your

chest. Your arm should be resting comfortably on the table

without making any eort. Do not speak or move during the

measurement.

4 - For ECG and Heart Sounds recording:

The excess cu should not overlap the stethoscope. For this

measurement, you should place the stethoscope in contact

with your chest, and the two electrodes inside the cu should

be in contact with your skin. Make sure that the stethoscope

is in contact with your chest during the measurement. Do not

speak or move during the measurement. Breathe normally. You

do not need to put your left hand on a table.

Standard mode

1- Two measurements in a

row will be taken during

this mode. The ﬁrst one is a

blood pressure measure-

ment, which you should take

in the position described on

page 5.

The second is a combined

measurement of an ECG and

Heart Sounds recording via

the stethoscope.

Standard mode

Other measurement modes

2- Push the button. The screen will display “START.” Push the button once again to start the

measurement. The blood pressure measurement starts.

3- When the screen displays the illustrated pictogram, it means that the blood pressure meas-

urement is ﬁnished and that you will now proceed to the ECG and stethoscope signal recording.

Adjust your arm position to place the stethoscope against your chest, and place your hand on

the metal tube to ensure an accurate measurement.

You can remove your hand from the table and follow the position described on page 5.

1- When you push the button to start Withings BPM Core,

you can also select “Start x3” or “ECG” by swiping the

touch-sensitive area on the screen. “Start x3” launches

three blood pressure measurements in a row followed by an

ECG and stethoscope measurement. “ECG” will only record

the ECG and stethoscope signals. Make sure to use the

correct arm position for each measurement type.

2- If an error message appears on screen, please refer to

the explanation displayed in the app and troubleshooting

procedures described beginning on page 9.

7. 8.

LED color signiﬁcation

The LED display on Withings BPM Core can be:

Blue: if Withings BPM Core has not been paired with a mobile

device yet.

Green: for optimal and normal blood pressure measurements.

The LED can also be green if Withings BPM Core has been

paired with a mobile device.

Orange: for high normal blood pressure measurements. The

LED can also be orange if Withings BPM Core has a low

battery (you can still take a measurement) or if there is an

error during one of the measurements during x3 measurement

mode. During x3 mode, you may see a short ERROR display

and orange LED, but afterward, it will give you the option

to restart the measurement. If you fail to get a result on the

second try, the LED will turn red.

Red: if hypertension (grade 1, 2, 3) or isolated systolic hyper-

tension are detected. The LED can also be red if Withings BPM

Core has no battery or if there is an error during the blood

pressure or stethoscope measurement

Pink: if you press and hold the monitor’s button for 6 seconds

until the Settings menu opens and “Training” is displayed on

the screen. The LED can also be pink when Withings BPM Core

has been factory reset.

Note: The LED color displayed on the device may vary depending on the

classification guidelines of your country. Please go to support.withings.com

for more information on blood pressure measurement classification.

VHD detection

Information related to VHD detection is available in the

Withings app.

ECG performance

Clinical performance

The ECG algorithm’s ability to accurately classify an ECG into

AFib and sinus rhythm was tested in a clinical trial of 115 sub-

jects. Rhythm classiﬁcation of a 12-lead ECG by a cardiologist

was compared to the simultaneous classiﬁcation of an ECG

recorded by Withings BPM Core.

Atrial ﬁbrillation

Sensitivity(%)

94.57 93.56

Speciﬁcity

Normal sinus rhythm

Sensitivity(%)

93.76 93.78

Positive

predictivity (%)

The ECG recording result on the mobile app provides a de-

tailed display of the result.

Withings BPM Core outputs

Measurement

Blood

pressure

ECG

Display

ECG NORMAL

SYS 127

DIA 82

HR 65

ECG AFIB

HIGH HR -

NO AFIB

ECG LOW HR

ECG TOO

NOISY

ECG

INCONCLUSIVE

ECG signal shows a normal sinus rhythm

Systolic blood pressure value in mmHg

Diastolic blood pressure value in mmHg

Heart rate value in beats per minute

ECG signal shows a risk of atrial ﬁbrillation

The recording does not appear to show any signs of atrial ﬁbrillation, but a complete diagnosis is not possible for a heart rate above 100

bpm. To obtain full analysis, the heart rate must be below 100 bpm during the recording.

The heart rate obtained cannot be classiﬁed as a recording. To obtain full analysis, the heart rate must be above 50 bpm during the

recording.

There is too much interference for the recording to be classiﬁed. Refer to the best practices section to know the right gestures to be

adopted and those to be avoided.

Inconclusive results.

Interpretation

Troubleshooting

The low battery icon is displayed on the device

The blood pressure cannot be taken and

the application shows an error message

Under normal circumstances, the measurement

taken at home may dier from the measurement

taken in a medical setting

Charge the device with the cable provided

1. Re-fasten the cu

2. Relax and sit down

3. Keep the cu at the same level as your heart during the measurement period

4. Keep silent and still during the measurement

5. If you have a severe heartbeat problem, the blood pressure may not be read correctly

1. The variation is due to the dierent environments

2. The blood pressure is changing according to the physiological or psychological status of the person being measured

3. Atrial ﬁbrillation may not be permanent in its early stages

4. Show your recorded values to your physician

Problem

No results for the ECG measurement

A valvular heart disease analysis cannot

be performed

The inﬂation action cannot be performed or

the air pressure cannot rise

Ensure that the three electrodes are in direct contact with the skin. If needed, clean them with a tissue.

Check the position of the stethoscope. The ﬂat surface must be in contact with the chest. Ensure that you performed the

required number of measurements to get a reading.

1. Check the cu position, fasten the cu correctly and remeasure blood pressure again

2. Check the blood pressure monitor’s connection to the iOS or Android device

Solution

If you cannot ﬁx the problem using the following troubleshooting instructions, please contact Withings

or go to: withings.com/support

Speciﬁcations & technical data

Product description: Automatic electronic blood pressure monitor with stethoscope, electrocardiogram and heart

rate sensor.

Model: WPM04

Blood pressure measurement method: Cu oscillometric method

Cu inﬂation: Automatic inﬂation with air pump at 5 mmHg/s

Pressure sensor: Gauge sensor

Measurement range (pressure): 0 to 285 mmHg, DIA 40 to 130 mmHg, SYS 60 to 230 mmHg

Measurement range (pulse): 40 to 180 beats/min

Pressure sensor accuracy: Within +- 3 mmHg or 2% of reading

Clinical accuracy (blood pressure): Withings BPM Core performance in blood pressure measurement was vali-

dated in a clinical trial. The results are within the margin of acceptance deﬁned by the internationally recognized

evaluation standard of blood pressure monitors ANSI/AAMI/ISO 81060-2:2013, EN ISO 81060-2:2014 and AAMI/

ESH/ISO 81060-2:2018, developed by the European Society of Hypertension, British Hypertension Society and

Association for the Advancement of Medical Instrumentation/American Heart Association. For more information,

go to: withings.com/support

Accuracy (pulse): Within +-5% of reading

Sensor: Semiconductor pressure sensor

Operating conditions: 5 to 40°C, 15 to 90% RH, atmospheric 86Kpa~106kpa, altitude: 2000m

Storage and transport conditions: -25 to 70°C, 10 to 95% RH, atmospheric 86Kpa~106kpa, Max altitude: 2000m

Arm type: Use on left arm

Internal Power source: 3.6 VDC Lithium ion battery

Weight: Approx. 430g

Expected minimum product life: 3 years

Wireless transmission: Wi-Fi and BLE

Note: Speciﬁcations are subject to change without prior notice or any obligation on the parts of the manufacturer

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