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1. Designated health indications
The BM-02 breathing monitor can be used to preventively monitor breathing in healthy individuals
(children). It is recommended to monitor the following indications:
o
Whooping cough - the monitor is recommended for 1 month after diagnosis - however, many
children have coughing fi ts for a longer period of time with the risk of vomiting and the potential
threat of inhaling vomit with all the consequences.
o
Apnea with bradycardia (slowed heart action) less than 80 beats per minute. The monitor is
recommended for 6 weeks after the symptoms disappear.
o
Muscle weakness - can be present in a whole range of muscular and neurological diseases with
varying prognosis. If it is a transient condition, it is recommended to monitor the infant for 6
weeks after the symptoms disappear.
o
Respiratory disorder associated with a decrease in blood oxygen content (desaturation),
the infant may be either pale or greyish/bluish. Monitoring recommended for 6 weeks after the
symptoms disappear.
o
Gastroesophageal refl ux (stomach contents returning to the oesophagus, even to the mouth) can
cause breathing problems up to apnoea, slowing of the heart rhythm or a drop in blood oxygen
levels - monitoring recommended for 6 weeks after symptoms disappear.
o
Documented apnoea of more than 20 seconds - monitoring for 6 weeks after the apnoea-
related condition ends.
o
Infant with an ALTE episode - a condition associated with a combination of apnea, a change
in the colour of the baby's skin and mucous membranes, a change in muscle tone, choking or
gagging. Monitoring appropriate for 6 weeks after an ALTE episode.
o
Infants with apnoea of prematurity - breathing suddenly stops for at least 20 seconds or
associated with a slowing of the heart rate (below 80 beats/minute) or a decrease in blood
oxygen content in an infant less than 37 weeks' gestation. Monitoring is recommended until 43
weeks' gestation and for a further 6 weeks without the above clinical symptoms.
o
Infants with bradycardia being treated with caffeine, theophylline and similar drugs - monitoring
6 weeks after treatment ends.
o
Infants with chronic lung disease (bronchopulmonary dysplasia), especially those who need
increased oxygen content in the inspired air, CPAP - Continuous Positive Airway Pressure or
mechanical ventilation.
o
Infants with neurological or metabolic disease affecting respiratory control - the recommended
duration of monitoring depends on the individual severity of the condition.
o
Infants with tracheostomies or anatomical anomalies causing vulnerability of the developing
airway - the need for monitoring depends on the individual disability.
o
Previous sibling died of SIDS - if the monitored child has no clinical signs that threaten respiratory
distress, then it is recommended to end monitoring 1 month after the age of the child who died
of SIDS.
o
Monitoring an infant in a paediatric inpatient ward after an ALTE episode - after discharge, home
monitoring is recommended depending on the cause of the episode.
2. Designated patient population
o
Age: from birth to typically 12 months (depending on the child's maximum recommended weight
corresponding to the physiological age up to 2 years, in exceptional cases, for non-physiological
cases, even above 2 years, but always taking into account the recommended maximum weight).
o
Recommended patient weight from 1 to 15 kg.
o
State of health: according to the specifi ed medical indication.
o
Ethnicity: multiple.
o
The patient is not a device user.
10
MFV52124
(859405253BM02ES)
BM-02 Usability Specifi cations
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