nanny BM-02 Bedienungsanleitung Seite 10

EN
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.
3. The BM-02 medical device is not intended for direct contact or transferred contact with
the patient's body.
4. Minimum specifi ed user profi le
o Age: 12 years + , with the ability to judge appropriate to his or her age.
o Knowledge: ability to distinguish the colours and meanings of the signal lights, ability to change
batteries in the device and install the device according to the instructions in the manual.
o Language aptitude: average ability to read and understand a text in the native language.
o Experience: basic experience with installing and operating simple electronic devices with the aid
of a manual.
o Other abilities: hearing and sighted individual, mentally competent to care for a child.
5. Intended environment and conditions of use
o It is intended for use in healthcare provider and home healthcare environments.
o It is designed to be used under a mattress with an insulating pad to protect against permeation.
o Not intended for use in transport means, unlockable cradles, prams, hammocks, hanging baskets,
in environments that easily transmit shocks and vibrations.
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MFV52121