NOxBOX mobile
NOxBOX®mobile
breath analysis is the new blood test
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NOxBOX®mobile with NOxBOX
®
+
or NOxBOX®O
2
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2
NOxBOX® mobile Operating Manual
English
Contents
1 Introduction 3
Intended Use 3
2 Environment 3
3 Safety 3
Basic Safety Recommendations 3
4 Warnings 4
Contraindications 4
5 System Contents 5
6 Instrument Layout 5
7 General Description 6
8 Manual Handling 7
9 Maintenance 8
10 Commissioning 8
11 Installing a Gas Cylinder 9
12 Cylinder Changeover 10
13 Initial Purge 11
14 Connecting to a Patient Circuit 12-13
15 Decommissioning 14
16 Dose Calculation 15
17 Manual Bagging 16
18 Calibration 17
19 Spares 18
20 Specification 18
21 Warranty 19
22 Troubleshooting 20-21
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NOxBOX® mobile Operating Manual
English
Introduction
Nitric oxide (NO) is administered as a selective
pulmonary vasodilator for conditions such as:
● Persistent pulmonary hypertension in new-
born babies (blue baby syndrome)
● Adult respiratory distress syndrome
● Acute post-operative cardiac patients
Intended use
The NOxBOXmobile is intended for use by
healthcare professionals in a medical environment
to administer nitric oxide (NO) to the breathing
circuits of patients undergoing inhaled NO (INO)
therapy.
The NOxBOXmobile has been designed to provide
adjustable continuous ow NO delivery to the
patient ventilator circuit to achieve the required
dose of NO to the patient.
The NOxBOXmobile must be used in conjunction
with a suitable Inhaled Nitric Oxide (INO) Therapy
monitor to conrm the correct dose of NO is
being delivered to the patient. Specically, the
NOxBOX+ and NOxBOXO2 monitors from the
Bedfont Scientic range of products are suitable
for use with the NOxBOX mobile. Refer to the
monitor Instructions for Use for correct operation,
maintenance and safety instructions.
Environment
The NOxBOX®O2 complies with the directive
EN60601-1-2 electromagnetic compatibility
but can be affected by cellular phones and by
electromagnetic interference exceeding the levels
specied in EN50082:1
Safety
Do not operate this equipment until you have read
and understood the operating, maintenance and
safety instructions included in this manual and any
manuals supplied with the INO Therapy monitor
being used.
Only trained and responsible personnel should
work with or around this equipment.
To avoid serious injury, pay attention to all
precautionary labels attached to equipment,
cylinders, containers and boxes prior to start-up.
Do not remove or obscure any label. If a label
is missing, becomes worn, or is difcult to read,
replace it with a new one. Product labels for the
NOxBOXmobile are available from your Distributor
or Bedfont Scientic representative.
Basic Safety
Recommendations
Prevent formation of unsafe atmospheres Ensure that properly engineered ventilation and
atmospheric monitoring systems are installed and
operating properly. Creating a conned space
presents the potential for unsafe atmospheres. If
dangerous levels of a gas are detected, evacuate
the affected area immediately. Do not re-enter the
area until safe conditions are restored.
Prevent injury - Ensure that all tools and
instruments used are in good condition. Be aware
that high-velocity gas may be released at vents and
safety relief valves.
Maintain safety devices - Check all safety devices
at least annually or as otherwise required by local
codes or manufacturer recommendations. Properly
maintain safety valves. Never bypass safety
devices, and never operate the equipment outside
its specied limits.
Ensure safe maintenance and repair - Only
qualied personnel should repair the equipment.
Ensure equipment is maintained according to the
manufacturer’s recommendations, including any
calibration or inspection routines.
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NOxBOX® mobile Operating Manual
English
Warnings
DANGER: Mishandling of pressurized process
equipment or gas cylinders can result in death,
serious injury, or property damage. Handle
pressurized equipment and cylinders with
extreme care and in accordance with the
manufacturer’s instructions.
DANGER: Both high-pressure connection
hoses should be correctly attached to the
NOxBOXmobile system at all times whilst the
system is pressurized.
DANGER: Poisonous gases can be fatal if
inhaled, even in very small quantities. Provide
adequate ventilation and appropriate personal
protective equipment (PPE).
This equipment contains poisonous gases.
The Threshold Limit Value (TLV) for each gas
refers, in general, to airborne concentrations
at or below which nearly all workers may be
repeatedly exposed without adverse effects.
The TLVs for the specialty gases used with this
equipment should be stated on the cylinder
body labels and the MSDSs (Material Safety
Data Sheets) for each gas.
Nitric Oxide (NO):
At room temperature and atmospheric pressure,
NO is a colourless, odourless, toxic, nonammable gas. It will readily combine with
atmospheric oxygen to form NO2.
Nitrogen Dioxide (NO2):
NO reacts with atmospheric oxygen to produce
NO2; the NO2 may react further with water to
produce nitric and nitrous acid which can both
be extremely corrosive. The human lungs
are a wet environment, so inhalation of this
extremely toxic gas can have severe effects and
every reasonable measure should be made to
minimise exposure to NO2.
Current UK HSE guidelines recommend
following the Chemical Hazard Awareness
Notice (CHAN) for nitrogen oxides (including
NO and NO2) state that time weighted average
(TWA) over eight hours should not exceed
1ppm.
Nitrogen (N2):
Nitrogen gas is an asphyxiant. A major
component of air, it is colourless and odourless
at room temperature. Care should be taken to
avoid excessive release of Nitrogen into the
atmosphere without adequate ventilation to
protect the user from a low-oxygen atmosphere
being created.
Contraindications
● Refer to your NO drug manufacturer’s
instructions for use, safety and warning
statements regarding contraindications for
the application of nitric oxide gas for the
purpose of INO therapy.
● NO gas is toxic at high concentrations and
appropriate continuous monitoring of the
applied patient dose concentration should
be used.
● WARNING: Sudden cessation of INO
therapy can cause complications such as
rebound hypoxia to occur.
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NOxBOX® mobile Operating Manual
English
NOxBOX+ monitoring instrument
1. NOxBOX
+
2. Mains power adapter
3. Magnum screwdriver
4. Calibration screwdriver
5. Sample line
6. Water trap
7. Naon tubing
8. Calibration T-piece adapter
9. Operating manual
10.PU tube from the naon to the inlet
NOxBOXmobile delivery system
A. Gas cylinder pressure gauges
B. Changeover unit
C. NOxAIR NO2 environmental sensor
D. Single stage regulator
E. Outlet pressure gauge
F. Trolley
G. Low ow indicator
H. High ow indicator
I. NOxAIR NO environmental sensor
J. Spanner attached by chain
System Contents
E
F
G H
I
J
A
B
C
D
A
NOxBOXO2 monitoring instrument
1. NOxBOXO
2
2. Water trap
Also supplied with:
Mains power adapter
Calibration screwdriver
Bacterial lter
Sample line
Water trap drainage accessory
Calibration Y-piece adapter
Operating manual
1
2
Figure 1
Instrument Layout
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NOxBOX® mobile Operating Manual
English
General Description
The NOxBOXmobile is used to control the
pressure and ow of NO gas into a patient
breathing circuit. The ow of NO gas is
controlled by the user via the adjustable
ow meter (See Fig.1, item G). When used
in conjunction with a NOxBOXO2 monitor, a
complete delivery and monitoring system is
formed that allows the user to set the patient
dose level and continuously monitor the dose
gas at patient side.
The NOxBOXmobile system is mounted to an
epoxy coated, mild steel trolley designed to be
situated close to the patient’s bedside ventilator.
The NOxBOXmobile system provides capacity
for two NO supply cylinders, up to 20L water
capacity, which when combined with the auto-
changeover system ensures uninterrupted
delivery of NO is possible. When used correctly,
this helps guard against sudden unexpected
withdrawal from INO therapy.
The system is tted with stainless steel high-
pressure hoses that attach to the cylinders
via suitable cylinder connectors (specic to
individual region). These hoses are tted with
a safety-cord to restrain the hose in the event
of a catastrophic pressure burst. Further safety
control measures are provided by a pressure
relief valve tted after the rst stage regulator,
with a second pressure relief valve tted after
the second stage regulator.
INO Therapy Monitor
The system trolley is provided with a shelf that
allows a NOxBOXO2 monitor to be xed to the
system, providing the monitoring capability.
Refer to the NOxBOXO2 manuals for safe use
and maintenance.
Environmental Alarms
Optional NOxAIR environmental gas detectors
can be provided to warn personnel of any
leaks in the NO supply. These portable alarms
continuously monitor the atmosphere for NO
or NO2 levels (depending on model), capable
of measuring down to 0.1ppm. Each monitor
has a set of alarms that can be set to ensure
best-practice environmental monitoring. These
alarms can be worn by an individual, positioned
in the vicinity of the patient or left on the hooks
provided on the NOxBOXmobile. Refer to the
NOxAIR environmental gas detector manuals
for safe use and maintenance.
Note: The NOxAIR alarms are personal alarms,
designed to alert staff in the immediate vicinity
of the alarm. They are not designed to be heard
from a long distance or from a different room.
NO Gas Cylinders
The NOxBOXmobile system is designed for
use with a medical-grade gas mixture of NO
balanced in Nitrogen (N2). The maximum
recommended concentration for use is
1000ppm NO. Bedfont Scientic do not provide
therapeutic gas mixtures for INO therapy.
Refer to the manufacturer’s labels regarding the
concentration and precise mixture of the NO/
N2 gas.
Please refer to the manufacturer’s instructions
on safe handling of the gas, gas cylinder and
any additional gas handling equipment provided.
All safety notices and warning should be read
and understood prior to use.
Warning: N2 gas is an asphyxiant, and care
should be taken to understand that adding
large quantities of N2 to the patient circuit may
cause dilution of the oxygen content of the
patient gases. It is recommended at all times
during INO therapy to use a monitor such as the
NOxBOXO2 that provides oxygen monitoring
capability to maintain awareness of this
phenomenon possibly occurring.
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NOxBOX® mobile Operating Manual
English
Manual Handling
The NOxBOXmobile system is handling a toxic
gas at high pressures. Care should be taken
when moving the trolley to ensure that it is
protected from excessive percussive knocks.
Before moving, ensure system brakes are
disengaged. Always use the metal frame of the
trolley to manoeuvre the system, ensuring a
secure grip to prevent unexpected movement.
Never attempt to move the equipment by pulling
on the system connection lines or gas cylinders.
When in use and attached to the patient, the
NOxBOXmobile should be placed to avoid any
tension within the connection lines to the patient
circuit. The system brakes should be applied to
prevent accidental movement of the equipment,
which could cause lines to disconnect from
the patient circuit or damage to any monitor
connections.
Gas cylinders can be heavy. Appropriate manual
handling techniques should be observed when
lifting cylinders on and off the system trolley.
Always engage system trolley brakes to stabilise
the platform prior to attempting to replace any
gas cylinders. Gas cylinders should be properly
restrained when on the trolley, using the
provided straps.
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