Withings BeamO - Intended Use

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Intended use Contraindications
SCT02 is a non-sterile, contactless, reusable clinical thermometer intended for the
intermient determination of human body temperature over the temporal artery as
the measurement site on people of all ages.
SCT02 is also an electronic stethoscope that enables the recording and transmis-
sion of heart and lung auscultation sound data. SCT02 is intended to be used by pro-
fessional users in a clinical environment or by lay users in anon-clinical environment
on people of all ages. 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.
SCT02 is also intended for the spot-checking of functional oxygen saturation of ar-
terial 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, accuracy may be im-
pacted
- DO NOT USE the ECG Afib Classification feature if you suer from
other arrhythmias.
- DO NOT USE the Thermometer feature on children born before term.
Warnings
This device should be handled with care:
- The device is not intended to continuously mon-
itor 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 re-
place 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 exam-
ined.
- The device does not provide alarms.
- This medical product can be operated by adults
only. Temperature and stethoscope measure-
ments 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 transmiing them
remotely. This medical product does not analyze
the sounds recorded.
- The power cord of the charger may pose a stran-
gulation 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), diather-
my (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 sel-diagnosis.
Sel-diagnosis and sel-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, diar-
rhea, pain, shivering, sti neck, etc., even if there
is no fever.