WITHINGS BEAMO SCT02 (01) PDF Document

The WITHINGS BEAMO SCT02 is a multifunctional device for at-home health checkups, which can perform the following measurements:

– A 1-lead electrocardiogram (ECG) with two stainless steel electrodes and Heart Rate (HR).

– A pulse oximeter to measure blood oxygen levels (SpO2) and pulse rate (PR).

– A contactless thermometer for body temperature measurements.

– A digital stethoscope to auscultate heart and lung sounds.

The measurements can be used on children and adults according to the table below:

*For US region: ≥ 22 years old

This medical device is intended to be used or operated by adults only with or without medical training. The SCT02 is suitable for non-professional use at home and can transmit data remotely. It is also designed for use by healthcare professionals.

The WITHINGS BEAMO SCT02 is a non-sterile, contactless, reusable clinical thermometer intended for the intermittent determination of human body temperature over the temporal artery as the measurement site on people of all ages.

The SCT02 is also an electronic stethoscope that enables the recording and transmission of heart and lung auscultation sound data. It is intended to be used by professional users in a clinical environment or by lay users in a non-clinical environment on people of all ages. The SCT02 measures, transfers, records, and displays lead I of an ECG. It calculates the heart rate and detects the presence of atrial fibrillation or sinus rhythm on a classifiable ECG waveform.

The SCT02 is also intended for the spot-checking of functional oxygen saturation of arterial hemoglobin (blood oxygen, or SpO2) and pulse rate (PR). It is indicated for use with individuals 18 years and older.

– DO NOT USE the ECG feature if you have a pacemaker, a defibrillator or other electric implant.

– DO NOT USE the device if you are pregnant, as accuracy may be impacted.

– DO NOT USE the ECG AFib Classification feature if you suffer from other arrhythmias.

– DO NOT USE the Thermometer feature on children born before term.

This device should be handled with care:

– The device is not intended to continuously monitor vital signs in critical conditions or where the nature of the variations is such that it could result in immediate danger to the user.

– The data provided by the device is intended for informational use only, and is not intended to replace traditional methods of definitive diagnosis or treatment.

– The device is intended to be used on intact skin only. Do not take measurements over irritated skin or scars. Do not perform auscultation if there are any wounds or abrasions within the spot examined.

– The device does not provide alarms.

– This medical product can be operated by adults only. Temperature and stethoscope measurements on children must be performed by an adult. Do not perform ECG and SpO2 measurements on children.

– The device contains an electronic stethoscope. It should be used solely for recording heart and lung auscultation sounds, and transmitting them remotely. This medical product does not analyze the sounds recorded.

– The power cord of the charger may pose a strangulation risk. Keep it away from children and pets.

– DO NOT take recordings while in proximity to or receiving medical treatment from other equipment (e.g., magnetic resonance imaging (MRI), diathermy (deep heating), lithotripsy, cauterization, and external defibrillation).

– This device should not be used as an apnea monitor. Oxygen changes may be delayed from when your breathing actually stops.

The device is not intended for self-diagnosis. Self-diagnosis and self-treatment are dangerous. Contact your physician in case of symptoms, doubt, questions or the following cases:

– If atrial fibrillation (AFib) is detected.

– If you experience symptoms that could indicate you are experiencing a sudden and/or severe change in health.

– If the temperature increases in neonates and babies under 3 months, patients over 60 years old, immunocompromised patients, bedridden patients, transplant patients.

– If other symptoms occur such as vomiting, diarrhea, pain, shivering, stiff neck, etc., even if there is no fever.

Factors that may degrade performance of the measurement of blood oxygen (pulse oximetry) include:

– Poor circulation, skin pigmentation, skin thickness, skin temperature, current tobacco use, and use of fingernail polish.

– Bright sunlight.

– Presence of strong electromagnetic fields.

– Failure to position fingertip on the device correctly.

– Tattoos on the fingers in the region of the optical sensor.

– Excessive motion of the arm or fingers.

– Low blood perfusion caused by room temperature below the recommended operation range, or by certain conditions such as Raynaud’s syndrome.

– Significant levels of dysfunctional hemoglobin (carboxyhemoglobin, methemoglobin).

– Venous pulsations.

– Intravascular dyes such as cardiogreen or methyl blue.

– Blood-flow restrictions due to arterial catheters, blood pressure cuffs, or infusion lines.

– Hypotension, serious vasoconstriction, serious anemia, or hypothermia.

The WITHINGS BEAMO SCT02 allows you to take 4 types of measurements:

① Blood oxygen (SpO2) and pulse rate (PR), using the pulse oximeter placed within the electrode surface.

② Simultaneous ECG and SpO2 measurement with heart rate (HR), using two electrodes and pulse oximeter.

③ Heart and lung sound recordings using the stethoscope.

④ Temperature measurements using the contactless thermometer.

To start a measurement:

1. Press the button to TURN ON the device.

2. Select the correct user.

3. Select the measure to start.

To TURN OFF the device press the button. There is an automatic switch-off after 30 seconds.

Before you start:

– The device and the patient should stay in the same ambient temperature room for 10 minutes prior to taking a measurement.

– Infant body temperature may vary more than adult body temperature. Avoid taking measurements on babies after nursing or while they are crying. It is recommended to take measurements on children when they are calm.

– For children under 3 months, perform 3 measurements in a row. If the 3 measurements are different, always take the highest one.

– If the patient has taken a bath or exercised, please wait for 15 minutes before taking a measurement.

– Move hair out of the way and dry any sweat before taking a measurement.

Taking your temperature:

1. Slowly scan once from the middle of the forehead to the top of the ear, as close as possible to the skin.

2. The device will vibrate when the measurement is complete. The temperature will be displayed on the device and the colored icon indicates the fever level according to the user’s age. The unit is either in °F or °C. You can change this unit in the Withings app settings.

LED Colors meaning:

■ No fever

■ Mild fever

■ High fever

There are 3 available recording modes on the WITHINGS BEAMO SCT02:

Heart: Recordings performed on 4 positions on the chest to listen to cardiac sounds.

Lungs: Recordings performed on 8 positions on the chest and back to listen to respiratory sounds.

Wide: Wide band recordings to listen to respiratory or cardiac sounds.

Before you start:

– Choose a calm, quiet room. Noises or murmurs may hurt the quality of recordings.

– Ensure you are in a comfortable position (preferably sitting down) with support for your hands (thighs or table).

– Do not speak or move during the measurement.

– Place the stethoscope directly on bare skin or wear at most one thin layer of clothing.

Taking a stethoscope recording:

1. Select either Heart, Lungs, or Wide mode on the device screen.

2. Select the position and place the stethoscope at the precise point indicated on the device screen.

3. When you are ready, press the button to start recording. Make sure that the stethoscope stays in contact with your body during the whole duration of the measurement.

You can listen to the auscultation sounds during the recording by connecting your headphones to the provided adapter and the USB-C port on the device. To adjust the volume, click up or down with the button before starting the recording. You can modify the order of the recording positions by selecting another position on the device. You may also end the exam before completing recordings in all indicated positions.

Before you start:

– Choose a calm, quiet room.

– Ensure you are in a comfortable position (preferably sitting down) with a support for your hands (thighs or table).

– Do not speak or move during the measurement.

Recording a simultaneous ECG and SpO2 measurement:

Place your index fingers on the electrodes. Your finger should cover the full length of the electrodes. Your finger contact should be light. The quality gauge guides you to keep a good, light contact throughout the measurement. Try to stay in the green zone.

1. Select ECGxSpO2 in the menu screen. Launch the measurement by pressing the button.

2. The recording will last for 30 seconds.

3. The end of the measurement is confirmed by a vibration.

Place your index finger on the right electrode. Your finger should cover the full length of the electrode. Your finger contact should be light. The quality gauge guides you to keep good, light contact throughout the measurement. Try to stay in the green zone.

1. Select SpO2 in the menu screen. Launch the measurement by pressing the button.

2. The recording will last for 15 seconds.

3. The end of the measurement is confirmed by a vibration.

SpO2 Output Results: A normal resting SpO2 level is typically 95% or greater. However, normal values can be lower for individuals with lung disease, advanced age, or those living at high altitude. SpO2 values generally vary between 90 and 100%.

– Between 95% to 100%: Normal.

– Between 90% to 94%: Below Average. This measurement detects that your blood oxygen level is below average but still normal. The results can vary based on a number of factors. We suggest you check for best practices and train to improve your gesture.

– Below 90%: Low. The value can be a possible sign of hypoxemia. The results can vary based on a number of factors including your health profile, your environment, and the way the measurement is done. If you repeatedly get this result or you’re not feeling well, you should talk to your doctor. Symptoms include being short of breath after exertion, coughing, fast or slow heart rate, rapid breathing, sweating.

Pulse Rate Output Results: The average pulse rate at rest is typically 60 to 100 beats per minute.

– Between 60 to 100 bpm: Normal.

– Below 60 bpm: Low Pulse Rate. This means your heart is beating less than 50 beats per minute (bpm). Some medicines can cause a low pulse rate. Talk to your doctor if you have questions about your pulse rate reading.

– Above 100 bpm: High Pulse Rate. This means your heart is beating above 100 beats per minute (bpm). A high pulse rate may be high because of exercise, stress, dehydration, infection, AFib, another arrhythmia or another cause. If you repeatedly get this result or you’re not feeling well, you should talk to your doctor.

After an ECG recording, you will see one of the following classifications. The classification of the ECG recording is for informational use only. If you are experiencing any symptoms or have concerns, contact your physician.

– Low Heart Rate (heart rate < 50 bpm): A Low Heart Rate result means your heart is beating less than 50 beats per minute (bpm). This recording cannot be classified by the device. Talk to your doctor if you have questions about your ECG recording.

– High Heart Rate (heart rate > 150 bpm): A High Heart Rate result means your heart is beating above 150 beats per minute (bpm). This recording cannot be classified by the device. Talk to your doctor if you have questions about your ECG recording.

– Sinus Rhythm (heart rate between 50-99 bpm): A Sinus Rhythm result means your heart rate is between 50 and 99 beats per minute (bpm) and is beating regularly.

– High Heart Rate (No signs of AFib): High Heart Rate (No signs of AFib) result means the heart rate is beating between 100 and 150 beats per minute (bpm) and does not show any signs of Atrial Fibrillation. Talk to your doctor if you have questions about your ECG recording.

– Atrial Fibrillation (heart rate between 50-99 bpm): An Atrial Fibrillation result means the heart rate is between 50 and 99 beats per minute (bpm) and is beating irregularly. If you have not been diagnosed with AFib before, you should talk to your doctor.

– Atrial Fibrillation High Heart Rate (heart rate between 100-150 bpm): An Atrial Fibrillation – High HR result means your heart rate is beating between 100 and 150 beats per minute and is beating with an irregular pattern. If you have not been diagnosed with AFib before, you should talk to your doctor.

– Inconclusive: An Inconclusive result means that the signal cannot be classified as Sinus Rhythm or Atrial Fibrillation, although the quality of the recording is good. This may be due to various conditions, including but not limited to other arrhythmias or other heart conditions. Talk to your doctor if you have questions about your ECG recording.

– Poor Recording: A poor recording result means the recording quality is low and the ECG cannot be classified. Some things that can cause this type of result are excessive movement, proximity to an electrical device that generates strong electromagnetic fields, or not following best practices for the gestures to be adopted. You may try to re-record your ECG.

– Clean the device with a soft and dry cloth before use. Do not use an alcohol-based or solvent agent.

– Do not submerge the device in water.

– [FOR HOSPITAL USE ONLY] For disinfection you may use Liquinox (Alconox).

– While the device is charging, it cannot be used. The USB-C port does not supply power during use.

– Store the device and the components in a clean and safe location.

Withings recommends that you add a passcode (personal identification number [PIN]), Face ID or Touch ID (fingerprint) to your phone to add a layer of security. It is important to secure your phone since you will be storing personal health information. Users should follow the authentication guidelines when logging into Withings App. Users will receive email alerts in case of changes related to password, two-factor authentication and recovery code. Users will also receive additional software update notifications via the Withings App, and updates are delivered wirelessly, encouraging rapid adoption of the latest security fixes. Users are able to see the currently installed firmware in the Withings App, under Devices > Withings BeamO. This tab also indicates if an update is available.

Do not install the device on a smartphone that you do not own. Do not use a public Wi-Fi network you don’t know. Use a trusted Wi-Fi network with your device. Use a secure channel when you are sharing personal information with your doctor. Withings also recommends upgrading your Withings App when an upgrade is available. The Withings App is not intended to be used on a computer. No anti-virus software is needed. Only use official app stores to download the Withings application. If needed, users can restore device configurations by following the factory reset procedure.

DC: Direct current

Model Number: Model Number

REF: Catalog number

Symbol with exclamation mark in a box: Do not use if package is damaged and consult instructions for use

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Book with “i”: Consult instructions for use or consult electronic instructions for use

MD: Medical device

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Calendar icon: Date of Manufacture

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CE 1282: The CE labeling certifies that the product complies with the general safety and performance requirements of Regulation 2017/745 Medical device

Box icon: Cardboard

CH REP: Swiss Authorized Representative

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SN: Serial number

UDI: Unique device identifier

Thermometer icon: Temperature range

Humidity icon: Upper and lower limits of relative humidity

Atmospheric pressure icon: Upper and lower limits of atmospheric pressure

IP22: Ingress of water or particulate matter

Umbrella icon: Keep dry