12
3 EQUIPMENT DESCRIPTION
The BEDFONT
NOxBOX
i
Intelligent Nitric Oxide Delivery and Monitoring System controls delivery
of nitric oxide (NO) gas into the ventilator inspiratory limb of the patient breathing circuit to provide
a consistent NO dose concentration in the inspired breath to the patient, as set by the user, for the
purposes of Inhaled Nitric Oxide (INO) therapy.
The NOxBOX
i
system is designed to be compatible with most ventilator models, using the
NOxFlow inline flow detection module to enable precise synchronized proportional NO delivery
into the inspiratory limb.
To ensure patient safety, the NOxBOX
i
system provides continuous monitoring of the inhalant
sample, analysing NO, oxygen (O
2
), and nitrogen dioxide (NO
2
) levels throughout treatment. It is
also equipped with a full suite of alarms.
The NOxBOX
i
system has an manual override failsafe circuit for continuous application of NO.The
NOxBOX
i
system has a simple delivery calculator and a set of look-up tables to enable best flow
selection.
For transport and transfer conditions, the NOxBOX
i
has a rechargeable internal battery that
provides over 4 hours’ use from full charge when no mains power source is available.
The scope of patient treatment is defined and controlled by the NO drug labelling. Primary
intended clinical setting is the Intensive Care Unit (ICU) with a secondary intended clinical setting
for the transport of ICU patients.
3.1 Intended Use
Always handle and store nitric oxide mixtures in accordance with
federal/national, state/provincial, and local codes and regulations.
WARNING:
In the event of an alarm triggering on the NOxBOX
i,
first take
measures to protect patient
prior to troubleshooting or repair of the device.
WARNING:
The NOxBOX
i
device is only intended for application of INO
therapy in combination with air and oxygen mixtures.
The NOxBOX
i
Nitric Oxide Delivery System is intended for use by healthcare professionals for the
delivery and monitoring of NO, and the monitoring of NO
2
and O
2
in the inspiratory ventilator lines
of a patient undergoing inhaled nitric oxide therapy (INO).
This system will perform as described within this Techincal Guide, user interface instructions,
system labels and/or inserts, when assembled, operated, maintained and repaired in accordance
with the instructions defined within this Technical Guide.
The NOxBOX
i
must only be used is accordance with the indications, contraindications, warnings
and precautions described in the Nitric Oxide drug packaging inserts and labelling. Refer to this
material prior to use.
1
With no alarm conditions
Summary of Contents for NOxBOX mobile
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