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rain.
9. The device should not be used under MRI, X ray, CT scan and infant warm -
er equipment.
10. Place the device away from the infant.
4.3 Warnings and Cautions
1. ApneBoot should not be used as sole basis for medical decisions. It must
be used in conjuction with clinical signs and symptoms.
2. ApneBoot does not detect through the respiration pattern of infants. It
alarms and stimulates when the infant has bradycardia and/or desaturation.
These events may or may not coincide with an apneic event marked by ces
-
sation of breathing.
3. If any measurements are questionable, then check the infant’s SpO
2
and
PR by alternate means. Also, check the ApneBoot device for proper opera -
tion.
4. Do not put the Stimulator Boot and Pulse Oximeter Probe if the infant’s
foot has any skin allergies and is chapped/itchy/red. This may result in ag
-
gravation of the allergy.
5. Remove the device (strap & stimulator boot) immediately if it results in any
kind of allergy or reaction on the infant foot.
6. For next patient, user must clean the stimulator boot and pulse oximeter
probe, as mentioned in the previous section, as otherwise it may result in
cross-contamination or transmission of infection.
7. The device detects and alerts by monitoring Bradycardia and Oxygen
Desaturation and helps resolve only primary apneas. It is not indicative of the
overall health of the infant.
8. The interpretation of the device’s indications should only be limited to the
presence of apnea and/or desaturation and bradycardia and not any other
symptoms or disease status.
9. ApneBoot monitors for Bradycardia and Oxygen Desaturation and alerts
caretakers by an audio-visual alarm. Caretakers must respond to the alarm
and intervene with appropriate action if stimulating the foot sole of the infant
does not help resolve all Apnea and/or oxygen desaturation and bradycardia.