Bempu ApneBoot, Operation Manual, Page: 7 / 48

7 www.bempu.com
1. PRODUCT DESCRIPTION
BEMPU ApneBoot is a pulse oximeter-based device that helps primary
apneas. It uses an inbuilt pulse-oximeter to monitor oxygen saturation and
pulse rate. In the event of apnea, as indicated by bradycardia and/or oxygen
desaturation, it uses a stimulator that vibrates the foot sole of the infant, to
stimulate the nervous system to restart breathing. The device also provides
an audio-visual alarm to get the caretakers attention to rapidly intervene
before any injury can occur.
The device operates on alternating current and also has an inbuilt battery to
provide a power backup of up to 12 hours.
1.1 Indications for Use and Contraindications
ApneBoot is intended to be used in clinical settings and mobile environments
like inter and intra-hospital transport, by trained medical personnel only. It
is intended to be used on preterm infants (with stimulation) and all infants
(without stimulation).
ApneBoot identifies apnea through bradycardia and/or oxygen desaturation
and not by respiration rate.
NOTE: All bradycardia and oxygen desaturation events may or may not coin -
cide with an apneic event marked by cessation of breathing.
The ApneBoot is designed to provide safe stimulus to help resolve primary
apneas which are central in nature. It cannot resolve secondary or obstruc
-
tive apneas.
The device is not intended to be used with highly critical infants who are kept
on ventilator support and/or any life support devices.
The device is not designed to be used at home and/or by any non-clinical
untrained staff.
Do not use this device in an MR environment.
Explosive Hazard: Do not use this device in an explosive atmosphere or in the
presence of flammable anesthetics or gases
This device does not meet defibrillation-proof requirements per IEC 60601-1.