NOxBOX O2
®
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NOxBOX®O2 Operating Manual
English
Contents
1
Intended use
3
2Safety
3
Basic Safety Recommendations3
3
Safe Operation Notes3
4
Environment
4
5Warnings
6
6
Important Notices
Single-Use
Cleaning
Maintenance and Storage
Contraindications
6
6
6
7
7
7Specification
8
Symbols8
2
8
Instrument layout
9
9
8
Operation10
Pre-use checks
10
Setting up the NOxBOX®O210
Connecting to the Patient Circuit
10-11
Switching Off
12
®
NOxBOX O2 Display
13
10Alarms
Setting Alarms
14
14
11 15
15
16
17
17
Calibration
Sensor Zero
NO Calibration
NO2 Calibration
O2 Calibration
12Troubleshooting
Resolving Alarms
18
18-20
13
20
Returns Procedure
14Spares
21
15Warranty
21
Intended use
The NOxBOX®O2 is intended for use by
healthcare professionals for monitoring the
levels of nitric oxide (NO), nitrogen dioxide
(NO2) and oxygen (O2) delivered to a patient
undergoing INO inhaled nitric oxide therapy).
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 delivery system 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 difficult to read,
replace it with a new one. Product labels for the
NOxBOX®O2 are available from your distributor
or NOxBOX Ltd representative.
Advice to the responsible organisation that
the assembly of medical equipment systems
and modifications during the actual service
life require evaluation to the requirements of
EN60601-1:2006.
Basic Safety
Recommendations
To prevent formation of unsafe atmospheres,
ensure that properly engineered ventilation
and atmospheric monitoring systems are
installed and operating properly. Creating
a confined 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.
required by local codes or manufacturer
recommendations. Never bypass safety devices,
and never operate the equipment outside its
specified limits.
Ensure safe maintenance and repair - Only
qualified personnel should repair the equipment.
Ensure equipment is maintained according to
the manufacturer’s recommendations, including
any calibration or inspection routines.
Safe Operation Notes
To avoid electric shock, this equipment must be
connected to a mains supply with a protective
earth.
The operator should not touch the patient
whilst in contact with either the computer or
the USB connector parts. The NOxBOX®O2
should only be connected to a computer that is
manufactured in accordance with EN60950 Safety of information technology equipment.
Ensure the monitor is out of reach of the patient
when in operation, at a distance of at least 1.5m
Please do not attempt to modify the equipment
in any way or use accessories not specified
by the manufacturer. Any attempt to do so will
invalidate the warranty and may affect the safety
of the device.
The monitor is not suitable for use in an oxygen
rich environment.
The monitor uses a sampling tube that may
come into contact with the patient’s skin during
normal procedures. For this reason, the sample
tube is considered as an Applied Part but it is
safe to use and offers no risks to the patient or
user.
To prevent injury, ensure that all tools and
instruments used are in good condition.
Maintain safety devices - Check all safety
devices at least annually or as otherwise
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NOxBOX®O2 Operating Manual
NOxBOX®O2 Operating Manual
English
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
specified in EN50082:1
Guidance and manufacturer’s declaration: Electromagnetic Immunity (IEC 60601-1-2)
The NOXBOX®O2 is intended for the use in the electromagnetic environment specified below. The
customer or the user of the NOxBOX®O2 should assure that it isused in such an environment.
Immunity test
IEC 60601
Test level
Compliance level
Electromagnetic
environment
guidance
Electrostatic
discharge (ESD)
±6 kV contact
±6 kV contact
± 8 kV air
± 8 kV air
Floor should be wood,concrete, or
ceramic tile. If floors are covered
with synthetic material, the relative
humidiity should be at least 30%.
Electrical fast
transient/burst
±2 kV for power
supply lines
±2 kV for power
supply lines
IEC 61000-4-4
±1 kV for input/
output lines
Mains power quality should be that
of a typical commerical
and/or hospital enviroment.
Surge
±1 kV
line to line
±1 kV
line to neutral
±2 kV
line to earth
±2 kV
line to earth
Mains power quality should be
that of a typical commercil and/or
hospital enviroment
IEC 61000-4-2
IEC 61000-4-5
<5 % U
(>95 % dip in UT)
for 0.5 cycle
Voltage dips, short
interruptions and
voltage variations
on power supply
IEC 61000-4-11
40 % U
(60 % dip in UT )
for 5 cycles
70 % U
(30% dip in UT)
for 25 cycles
<5 % U
(95 % dip in UT) for 5
cycles
Power frequency
(50/ 60 Hz)
magnetic field
IEC 61000-4-8
3 A/m
60 % dip to x 5
cycles
Mains power quality should be
that of a typical commercial and/or
hospital environment.
If the user of the NOxBOX®O2
requires continued operation
during power mains interruption,
it is recommended that the
NOxBOX®O2 be powered from
an uninterruptible power supply or
battery.
100% dip for 5s
3 A/m
Power frequency magnetic
fields should be at levels
characteristic of a typical location
in a typical commercial or hospital
environment.
Note: UT is the A.C. mains voltage prior to application of the test level.
4
Guidance and manufacturer’s declaration: Electromagnetic Immunity (IEC 60601-1-2)
The NOxBOX®O2 is intended for the use in the electromagnetic environment specified below. The customer or the user
of the NOxBOX®O2 should assure that it is used in such an environment.
Immunity test
Conducted RF
IEC 61000-4-6
IEC 60601
Test level
3 V rms
150 kHz ~
80MHz outside
ISM bands*
10 V rms
150 kHz ~
Radiated RF
IEC 61000-4-3
Compliance
level
3 V rms
10 V/m
80MHz in ISM
Electromagnetic environment– guidance
Portable and mobile RF communications equipment
should be used no closer to any part of the
NOxBOX®O2 including cables, than the recommended
separation distance calculated from the equation
appropriate to the frequency of the transmitter.
Interference may occur in the vicinity of equipment
marked with he following symbol:
bands*
10 V rms
80 kHz ~
2.5 GHz
80MHz to
2.5GHz
Note1: At 80 MHz and 800 MHz, the higher frequency range applies.
Note2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects, and people.
The ISM (industrial, scientific, and medical) bands between 150 kHz and 80 MHz are 6.765 MHz to 6.795 MHz; 13.553
MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz.
The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80
MHz to 2.5 GHz are intended to decrease the likelihood that mobile/portable communications equipment could cause
interference if it is inadvertently brought into patient areas. For this reason, an additional factor of 10/3 is used in
calculating the recommended separation distance for transmitters in these frequency ranges.
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile
radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy.
To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be
considered. If the measured field strength in the location in which the NOxBOX®O2 is used exceeds the applicable RF
compliance level above, the NOxBOX®O2 should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as reorienting or relocating the NOxBOX®O2.
Over the frequency ranges 150 kHz to 80 MHz field strength should be less than 3 V/m.
The NOxBOX®O2 is intended for use in the electromagnetic environment specified below. The user of the NOxBOX®O2.
should assure that it is used in such an environment
Emissions test
RF emissions
CISPR 11
RF emissions
CISPR 11
Compliance
Electromagnetic environment - guidance
Group 1
The NOxBOX®O2. uses RF energy only for its internal
function. Therefore, its RF emissions are very low and are
not likely to cause any interference in nearby electronic
equipment.
Class B
The NOxBOX®O2. is suitable for use in all establishments,
including domestic establishments and those directly
connected to the public low-voltage power supply network
that supplies buildings used for domestic purposes.
A separation distance is not applicable to the NOxBOX®O2 since it does not incorporate intentional transmitters. It is
however good practice to keep at least 300mm separation from other equipment used in the same environment.
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NOxBOX®O2 Operating Manual
NOxBOX®O2 Operating Manual
English
Warnings
Important Notices
DANGER: Poisonous gases can be fatal if
inhaled, even in very small quantities. Provide
adequate ventilation and appropriate personal
protective equipment (PPE).
Single-Use
This equipment monitors 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.
The following items listed and approved for
use with the NOxBOX®O2 are single-patient
use only. These items are not reprocessible
and should be properly disposed of after use
according to local guidelines for such items:
●● The protective filter
●● The sample line
●● The water trap drainage syringe
1
Nitric Oxide (NO):
Cleaning
At room temperature and atmospheric
pressure, NO is a colourless, odourless, toxic,
non-flammable gas. It will readily combine with
atmospheric oxygen to form NO2.
Wipe the instrument and external surfaces with
a product specifically developed for the purpose.
NOxBOX Ltd provides Instrument Cleansing
Wipes.
Nitrogen Dioxide (NO2):
●● Never use alcohol, cleaning agents
containing alcohol, or other organic solvents
to clean the monitor. Vapours from such
chemicals will damage the internal sensors.
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.
6
●● Under no circumstances should the
instrument be immersed in or splashed with
liquid.
●● NOxBOX®O2 is not suitable for sterilization.
●● To clean the water trap, use any of the
three fluid path luer lock ports to introduce
cleaning fluid. Do not use any alcohol or
organic-based solvents to clean the water
trap as this may damage the sensors. Do
not submerge the water trap in liquids as
this may cause damage to the electrical
sensor.
●● Ensure all cleaning substances are
thoroughly drained and removed from the
water trap before use.
English
NOxBOX®O2 Operating Manual
Maintenance and Storage
●● Calibration should be checked regularly,
in accordance with the instructions in this
manual (see “Calibration” section, Page 13).
●● Temperature may affect the accuracy of
the NOxBOX®O2. The instrument should
be calibrated at the temperature at which it
is expected to be used. If the NOxBOX®O2
is used at a lower temperature than when
it was calibrated, readings may be lower;
if used at a higher temperature than when
calibrated, readings may be higher.
NOxBOX Ltd will make available on request
circuit diagrams, components part lists,
descriptions, calibration instructions, or
other information which will assist the user’s
appropriately qualified technical personnel
to repair those parts of equipment which are
designed by the manufacturer as repairable,
following service training.
Contraindications
●● The nitric oxide sensor is cross-sensitive
to nitrogen dioxide, but not significantly
enough to affect the unit during use.
●● 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.
●● Prior to storage, ensure that the
NOxBOX®O2 is correctly decommissioned
following use. See “Operation” section,
“Switching Off” Page 10.
●● NO gas is toxic at high concentrations and
appropriate continuous monitoring of the
applied patient dose concentration should
be used.
●● Store the NOxBOX®O2 connected to
the mains supply to prevent the battery
losing charge. In the event that the battery
discharges, the sensors will no longer be
biased.
●● WARNING: Sudden cessation of INO
therapy can cause complications such as
rebound hypoxia to occur.
●● In the event of sensor bias being lost, the
unit needs to be plugged in to the mains for
at least 6 hours (recommended 24 hours)
before performing a full sensor calibration
(see Calibration section, Page 13).
●● In the event of a sensor failing to calibrate,
or if a sensors performance begins to
degrade, the sensor needs to be changed.
Refer to the NOxBOX®O2 maintenance
manual for instructions on sensor
replacement. This can only be performed by
a NOxBOX Ltd qualified service engineer or
the unit warranty will be void.
●● Typical life expectancy for the NOxBOX®O2
sensors is 1 – 2 years when correctly
maintained and operated according to these
instructions.
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NOxBOX®O2 Operating Manual
English
Specification
Measuring range:
0-99.9 ppm NO
0-19.9 ppm NO2
0-100% O2
Means of disconnection
Mains plug
Mode of operation:
Continuous
Sample flow rate:
Approx. 250 ml/min
Detection principle:
Sealed electrochemical sensor
Accuracy:
<5% of reading
Display:
Graphical LCD
Alarms:
Audible and visible
Warm-up time:
<2 minutes
Response time:
<10 seconds to 90% FSD NO
<30 seconds to 90% FSD NO2
Operating temperature:
10-40°C
Operating Humidity:
30-75%
Transport/storage temperature:
10-40°C
Transport/storage humidity:
30-75%
Operating/transport/storage pressure:
700-1013mbar
Sensor operating life:
1-2 years
Sensor resolution:
0.1ppm NO and NO2
Battery:
4-6 hours (operational) 12v, 2.3Ah (YUA5A;NP2.3-12)
Power input:
230v, 50Hz/60Hz, 110mA (optional)115v, 60Hz, 220mA
Dimensions:
240 (D) × 210 (W) × 140 (H) mm
Weight:
Approx. 4 kg (including batteries)
Construction:Aluminium
Ceramic fuse:
T 315mAH 250V (x2) IEC 60127 Compliant
Ceramic fuse: T 160mAH 250V (x2) IEC 60127 Compliant
Symbols
Alternating current
Direct Current
Degree of protection against electric shock:
Type BF applied part
Degree of safety of application in the prescence of
a flammable anaesthetic mixture with air oxygen or
nitrous oxide: Equipment not suitable for use in the
presence of flammable mixtures.
8
Type of protection against electric shock:
Internally Powered Equipment
Class I equipment; (earthed)
iNO therapy can be hazardous if not
Caution applied correctly.
Please refer to the warnings and
safety notes in this manual
Degree of protection against ingress of liquid:
IPXO - not protected against water ingress
Consult instructions for use
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NOxBOX®O2 Operating Manual
Instrument layout
1
NO high alarm control
12
Cut-off valve (Not used)
2
NO low alarm control
13
Exhaust
3
NO2 high alarm control
14
Sample Inlet
4
O2 low alarm control
15
5
Manual zero
IEC power socket 230v
(115v, optional)
6
NO/NO2/O2 calibration adjusters
16
Anti-surge fuses
7
LCD screen
17
On/off Switch
8
Mute button
18
Water trap
9
Charging LED
19
Luer lock release valve
10
Water trap sensor connector
20
Protective filter
11
Zero reference
21
USB (optional)
22
Handle
1
3
22
21
6
11
12
10
20
5
2
14
4
19
15
16
7
17
!
13
9
8
18
CAUTION: Ensure that the mains plug
is not obstructed to facilitate easy removal from
the mains socket.
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NOxBOX®O2 Operating Manual
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Operation
The NOxBOX®O2 is supplied assembled and
ready for use. Prior to shipment, all units are
zeroed with pure air and calibrated with certified
NO in N2 and NO2 in air.
3.
Once the auto zeroing process is complete,
check that the NO and the NO2 readings
are 0.0ppm, and that the O2 reading is
20.9% (±0.2%) absolute.
4.
If the unit is out of calibration, it must be
calibrated prior to use to ensure reliable
reading of the dose. To calibrate the
unit, follow the procedure described in
Calibration, Page 13.
5.
Adjust the four gas alarms (described
under Alarms section, Page 12) at levels
appropriate to facilitate best monitoring
and awareness for the individual patient
treatment.
6.
The NOxBOX®O2 is now ready to connect
to the patient circuit.
Pre-use checks
●● Ensure that the water-trap is empty before
use.
●● If the water trap needs emptying, use the
supplied drainage syringe by screwing
onto the water trap Luer lock on the rear of
instrument (see Instrument layout, page 7)
and drain the water if required.
●● Calibration is recommended once a week
during use, or once a month during storage.
NOxBOX Ltd recommends that the unit is
calibrated prior to use if calibration has not
been carried out within these timescales.
Follow the instructions for calibration on
page 13.
●● Checking the function of this critical care
piece of equipment is important and these
instructions must be adhered to.
Setting up the
NOxBOX®O2
Connecting to the Patient
Circuit
1.
Install a new patient filter to the exit of
the water trap. Twist the blue luer collar
on the water trap exit to the filter inlet
(filter inlet side printed with FIL042A, see
Fig. 1). Twist the blue luer collar on the
green tubing to the filter outlet (see Fig. 1).
NOTE: Filter is a single-patient use item
and must be replaced before each use.
Connect the power lead to the NOxBOX®O2 via
the socket on the rear panel (see Instrument
Layout, Page 7). Connect to the electricity
supply. The charging LED located at the front of
the monitor should now be illuminated. NOTE:
on units with serial number up to NBO454, this
LED will be located to the rear of the monitor.
1.
Switch the monitor on using the on/off
switch at the back of the unit. The green
LED on the power switch should light up.
2.
The NOxBOX®O2 monitor will begin auto
zeroing and ‘Zeroing’ will be displayed
while this process takes place.
Figure 1: Patient Filter correctly installed
10
2.
3.
Unwrap a new patient sample line. Attach
the female luer end to the blue luer collar
on the water trap inlet. The free end of the
line will attach to the patient circuit using a
luer-port adaptor connector. The NOXKIT-V
with NOXKIT- NEONATE, NOXKIT-CHILD
or NOXKIT- ADULT, available from
NOxBOX Ltd or your distributor, contains
standard size vent circuit adaptors with luer
ports to allow simple connection to most
ventilator circuits.
English
NOxBOX®O2 Operating Manual
2
The sample point on the patient circuit
should be located on the inspiratory
limb, as close as possible to the patient
Y-piece as possible (Fig. 2). NOxBOX
Ltd recommends that a one-way valve
is installed between the patient and the
sampling point to prevent dilution effects
from patient exhalant gas. This will allow
for the most accurate reading of the dose.
Figure 2: Connection to patient
Figure 2-a: Connection
Including NOxBOX Mobile
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NOxBOX®O2 Operating Manual
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Switching Off
1.
Once the treatment is complete and the
NOxBOX®O2 is no longer required, follow
these steps to safely decommission ready
for cleaning and storage:
2.
Disconnect the patient sample line from
the ventilator circuit. Disconnect patient
sample line from water trap luer. Dispose
of patient sample line in accordance with
local procedures for such items.
3.
Disconnect the patient filter from the outlet
of the water trap and inlet to the monitor.
Dispose of patient filter in accordance with
local procedures for such items.
4.
Drain the water trap using an appropriate
clean syringe. Drainage syringes can
be obtained from NOxBOX Ltd or your
distributor. Dispose of the syringe in
accordance with local procedures for such
items.
5.
Switch off the NOxBOX®O2 monitor using
the power switch at the rear. Disconnect
the mains plug from the wall socket.
6.
Clean the device in accordance with local
procedures prior to storage. IMPORTANT:
read all safety notices and warnings
relating to cleaning products to prevent
damaging the monitor.
7.
NOxBOX®O2 is ready for storage. NOTE:
Read “Maintenance & Storage” section
under “Important Notes, Page 5,” at the
front of this manual.
12
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NOxBOX®O2 Operating Manual
NOxBOX®O2 Display
A
0.0PPM
NO:
B
0.0
NOHi = 30/6
25.0
NO2hi = 2.0
12.0
20.9
O2
NO2
% C
PPM
NOLo = 00.0
O2low = 16.0
PMP /B
H2O
BATlow
D
Figure 3: NOxBOX®O2 display, labelled
The sample gas monitored values are displayed in the upper section of the screen in Fig. 3.
A. Nitric oxide gas in parts per million (ppm)
B. Nitrogen dioxide gas in ppm
C. Oxygen gas as percentage (%)
The lower section of the screen displays alarm settings and messages
D. Seen in Fig. 3. Reading from top left to bottom right:
ALARM
INDICATIONRANGE
NOHi
Shows value at which the NO high alarm is set (ppm)
0 – 99.9
NOLo
Shows value at which the NO low alarm is set (ppm)
0 – 99.9
O2low
Shows value at which the O2 low alarm is set (%)
16.0 – 99.9
NO2hi Shows value at which the NO2 high alarm is set (ppm)
0 – 19.9
PMP/B
Flashes and sounds when pump or sample line is blocked
---
H2O
Flashes and sounds when water trap needs to be drained
---
BATlow Flashes and sounds when battery is low
---
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NOxBOX®O2 Operating Manual
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Alarms
In the event of an alarm, the display will flash to
indicate which alarm has been triggered and an
audible alarm tone will sound. The NOxBOX®O2
monitor has a mute button located directly under
the display, press and hold for 3 seconds to
mute the alarm for approx. 2 minutes.
Setting the NO2 high alarm
Setting Alarms
●● Adjust “O2 low” control dial until O2 low
displayed on the screen reaches the
appropriate value and is stable.
The four gas level alarms are user set via the
control dials located on the right hand side of
the monitor (See “instrument layout”, Page 7).
●● Setting the gas level alarms to the correct
level is dependent on the healthcare
professional, and should be used
appropriately.
●● NOxBOX Ltd recommends that the gas level
alarms are set to raise an alert in the event
that the patient circuit gas levels are reading
out of acceptable bounds, based on the
conditions set for that patients, e.g. oxygen
level and intended NO dose level.
●● When changing any settings within the
patient circuit that may affect the monitored
levels, remember to make any appropriate
adjustments to these alarms.
Setting the NO high alarm
●● Adjust “NO hi” control dial until NOHi
displayed on the screen reaches the
appropriate value and is stable. This should
always be set at more than the desired NO
dose level.
Setting the NO low alarm
●● Adjust “NO low” control dial until NOLo
displayed on the screen reaches the
appropriate value and is stable. This should
always be set at less than the desired NO
dose level.
14
●● Adjust “NO2 hi” control dial until NO2
hi displayed on the screen reaches the
appropriate value and is stable.
Setting the O2 low alarm
●● NOTE: minimum setting is 16.0%
Calibration
Calibration of the NOxBOX®O2 should be carried
out once a week during use and once a month
during storage.
Refer to the safety notices on handling toxic and
asphyxiating gases at the front of this manual.
Refer to the individual gas MSDSs for full safety
data for the gas being used.
The area used to calibrate the NOxBOX®O2
should be well ventilated and appropriate PPE
such as safety goggles should be worn. Use an
ambient environmental monitor for NOx gases
such as the NOxAIR personal alarms available
from NOxBOX Ltd during calibration.
Sensor Zero
IMPORTANT: Before carrying out any calibration
procedure, it is essential for the NOxBOX®O2 to
complete a full zeroing process which sets the
baseline reading for the sensors. No special gas
connections are required.
●● The NOxBOX®O2 will automatically zero
as it is switched on, wait until the screen
displays the normal monitoring screen
before calibrating.
●● If the unit is already on prior to commencing
calibration, perform a manual zero by
pressing the button located next to the
alarm adjustment dials on the right of the
monitor. The zero process should take
approximately 2 minutes.
1
NOTE: During the zero, the screen will display
“zeroing” (Fig. 4) and display two sets of
numbers below this. These numbers are for
diagnostic purposes should there be a problem
with the calibration procedure, and can help the
technical support team diagnose any issues that
may have occurred with the monitor.
ZEROING
10 58
Figure 4: NOxBOX®O2 display, showing Zeroing
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NOxBOX®O2 Operating Manual
NOxBOX®O2 Operating Manual
English
IMPORTANT: Ensure the NOxBOX®O2 unit
has been stored correctly on charge prior to
calibration. If the unit battery has been allowed
to run down, the sensors may lose bias and the
unit must be connected to the mains and left on
charge for a minimum of 6 hours to ensure the
sensor is fully biased prior to calibration.
Nitric oxide (NO) Calibration
IMPORTANT: Ensure the NOxBOX®O2 readings
are at or near expected baseline values (NO =
0.0, NO2 = 0.0, O2 = 20.9%) before performing
the NO calibration procedure. If following on
from another sensor calibration, this process
should take no more than 2 – 3 minutes.
Calibration Gas: A certified gas cylinder
containing 25ppm NO balanced in nitrogen,
supplied by NOxBOX Ltd.
●● Once the NO value displayed is stable, the
display reading can be adjusted to match
the value of the certified calibration gas.
Using the calibration screwdriver supplied,
locate the tip of the screwdriver into the
“NO span” potentiometer screw located on
the right side of the monitor. Gently turn
the screw to adjust the displayed value as
appropriate.
●● Turn the control valve on the regulator off to
stop the flow of NO gas.
●● Disconnect the calibration line from the
water trap.
●● Disconnect the regulator from the calibration
cylinder.
2
Procedure:
●● Attach the stainless steel miniature
regulator, supplied by NOxBOX Ltd to the
gas cylinder valve. Ensure the control valve
is closed.
●● The outlet of the regulator should be
attached to the supplied calibration line
clear plastic NOX-Y-CAL tubing. This tubing
has a y-piece exhaust to ensure that the
sensors receive the correct level of gas and
are not damaged by over-pressure.
●● Connect the luer on the free-end of the
calibration tubing to the inlet luer of the
water trap on the NOxBOX®O2 (See figure
5.)
●● Open the control valve on the regulator. The
flow is automatically set to approximately 1
litre per minute (±0.2ltr/ minute).
●● Allow approximately three minutes for the
NO gas reading to stabilise. NOTE: during
this procedure, the O2 level will fall to
near zero, causing the O2low alarm to be
triggered. The calibration gas contains no
oxygen, this is normal. Mute alarm during
NO calibration.
16
Figure 5: Calibration Procedure
Nitrogen dioxide (NO2)
Calibration
●● Disconnect the calibration line from the
water trap.
IMPORTANT: Ensure the NOxBOXO2 readings
are at or near expected baseline values (NO =
0.0, NO2 = 0.0, O2 = 20.9%) before performing
the NO2 calibration procedure. If following on
from another sensor calibration, this process
should take no more than 2 – 3 minutes.
Oxygen (O2) calibration
Calibration Gas: A certified gas cylinder
containing 10ppm NO2 balanced in air, supplied
by NOxBOX Ltd.
3
Procedure:
●● Attach the stainless steel miniature
regulator, supplied by NOxBOX Ltd to the
gas cylinder valve. Ensure the control valve
is closed.
●● The outlet of the regulator should be
attached to the supplied calibration line
clear plastic NOX-Y-CAL tubing. This tubing
has a y-piece exhaust to ensure that the
sensors receive the correct level of gas and
are not damaged by over-pressure.
●● Connect the luer on the free-end of the
calibration tubing to the inlet luer of the
water trap on the NOxBOX®O2.
●● Disconnect the regulator from the calibration
cylinder
IMPORTANT: Ensure the NOxBOX®O2
readings are at or near expected baseline
values (NO = 0.0, NO2 = 0.0, O2 = 20.9%)
before performing the O2 calibration
procedure. If following on from another sensor
calibration, this process should take no more
than 2 – 3 minutes.
Calibration Gas: Scrubbed ambient air at
20.9%
Procedure:
●● Allow the NOxBOX®O2 readings to
return to the normal baseline values and
stabilise.
●● Using the calibration screwdriver supplied,
locate the tip of the screwdriver into the
“O2 span” potentiometer screw located on
the right side of the monitor. Gently turn
the screw to adjust the displayed value as
appropriate.
●● Open the control valve on the regulator. The
flow is automatically set to approximately 1
litre per minute (±0.2ltr/ minute).
●● Allow approximately three minutes for the
NO2 gas reading to stabilise.
●● Once the NO2 value displayed is stable, the
display reading can be adjusted to match
the value of the certified calibration gas.
Using the calibration screwdriver supplied,
locate the tip of the screwdriver into the
“NO2 span” potentiometer screw located
on the right side of the monitor. Gently turn
the screw to adjust the displayed value as
appropriate.
●● Turn the control valve on the regulator off to
stop the flow of NO2 gas.
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17
English
NOxBOX®O2 Operating Manual
NOxBOX®O2 Operating Manual
English
Troubleshooting
Resolving Alarms
In the first instance of an alarm sounding,
the effect on the patient, their condition and
treatment is the overriding priority. Check and
safeguard patient condition before attending to
the monitor.
The following advice should help resolve the
alarm condition. If the advice herein fails,
contact your service engineer for assistance. It
may be appropriate to replace a malfunctioning
monitor in worst case.
being a fault with this monitor.
●● If all above steps have not resolved the
issue, consider replacing the NO supply
cylinder.
IMPORTANT: the NO gas flow levels should
not deviate substantially (e.g. > +/- 30%) from
the guideline settings recommended for the
patient vent flow and NO supply cylinder.
Rule out a fault with the monitoring equipment
before substantially altering the NO flow from
the delivery device.
NOLo
For any on-going issues, or to obtain more in-depth technical assistance on these products,
please contact NOxBOX Ltd’s technical support
at www.noxboxltd.com and click on “Technical
support”.
●● Check patient is still breathing.
ALARM / ACTION:
●● If O2low alarm is sounding at the same
time, there is likely to be a leak in the patient
sample path. Check connection of patient
sample line connection to the ventilator and
NOxBOX®O2 is free from leaks.
1
NOHi
●● Check patient is still breathing.
●● Check inspiratory ventilator flow is
present and free from leaks or broken
connections.
●● Check NO delivery device flow setting is
correct for patient ventilator flow and NO
supply cylinder concentration.
●● If appropriate, reduce NO flow from
delivery device and allow 2 minutes
before re-assessing NO levels. NOTE:
the 2 minutes allows the full impact of
any changes to be recorded.
●● Perform a manual zero on the
NOxBOX®O2 by pressing the zero button
on the right side of the monitor. NOTE:
this process takes approximately 2
minutes.
●● If NO reading is still high, replace the
monitor for another unit to exclude there
18
●● Check inspiratory ventilator flow is present
and free from leaks or broken connections.
●● Check connection of NO supply line from
delivery device to ventilator circuit is free
from leaks.
●● If PMP/B alarm is sounding at the same
time, the low NO reading may be due to
a kink or blockage in the sample path.
Resolve this alarm and monitor system for
2 minutes to see if the NO level reading
recovers.
●● If NO2hi alarm is sounding at same time,
the delivery gas system may have suffered
oxidisation. This can be resolved by purging
the delivery system lines. Refer to the
delivery system manual for instructions and
warnings on purging.
●● Check NO delivery device flow setting is
correct for patient ventilator flow and NO
supply cylinder concentration.
●● If appropriate, increase the NO flow from
delivery device and allow 2 minutes
before re-assessing NO levels. NOTE:
the 2 minutes allows the full impact of any
changes to be recorded.
for 2 minutes to see if the O2 level reading
recovers.
●● Perform a manual zero on the NOxBOX®O2
by pressing the zero button on the right side
of the monitor. NOTE: this process takes
approximately 2 minutes.
●● Perform a manual zero on the NOxBOX®O2
by pressing the zero button on the right side
of the monitor. NOTE: this process takes
approximately 2 minutes.
●● If NO reading is still high, replace the
monitor for another unit to exclude there
being a fault with this monitor.
●● If O2 reading is still low, replace the monitor
for another unit to exclude there being a
fault with this monitor.
●● If all above steps have not resolved the
issue, consider replacing the NO supply
cylinder.
NO2hi
IMPORTANT: the NO gas flow levels should
not deviate substantially (e.g. > +/- 30%) from
the guideline settings recommended for the
patient vent flow and NO supply cylinder. Rule
out a fault with the monitoring equipment before
substantially altering the NO flow from the
delivery device.
O2low
●● Check patient is still breathing.
●● Check inspiratory ventilator flow is present
and free from leaks or broken connections.
●● Check NO delivery device flow setting – at
high flow rates, there can be significant
volumes of N2 gas being delivered into the
patient ventilator lines which can dilute
the O2 levels. Adjust relevant equipment
settings to correct for this effect if required.
Allow 2 minutes after adjusting any levels
before reassessing the monitored gas
values.
●● If NOLo alarm is sounding at the same time,
there is likely to be a leak in the patient
sample path. Check connection of patient
sample line connection to the ventilator and
NOxBOX®O2 is free from leaks.
●● If PMP/B alarm is sounding at the same
time, the low O2 reading may be due to
a kink or blockage in the sample path.
Resolve this alarm and monitor system
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IMPORTANT: NO2 is a highly toxic pulmonary
irritant. Remedial action for high NO2 levels
should be implemented immediately to protect
the patient.
●● Check patient is still breathing.
●● Check inspiratory ventilator flow is present
and free from leaks or broken connections.
●● Check NO delivery device flow setting is
correct for patient ventilator flow and NO
supply cylinder concentration.
●● If appropriate, reduce NO flow from delivery
device and allow 2 minutes before reassessing NO2 levels. NOTE: the 2 minutes
allows the full impact of any changes to be
recorded.
●● Perform a manual zero on the NOxBOX®O2
by pressing the zero button on the right side
of the monitor. NOTE: this process takes
approximately 2 minutes.
●● If NO2 reading is still high, replace the
monitor for another unit to exclude there
being a fault with this monitor.
●● If all above steps have not resolved the
issue, consider replacing the NO supply
cylinder.
IMPORTANT: The NO gas flow levels should
not deviate substantially (e.g. > +/- 30%) from
the guideline settings recommended for the
patient vent flow and NO supply cylinder.
Rule out a fault with the monitoring equipment
before substantially altering the NO flow from
19
English
NOxBOX®O2 Operating Manual
NOxBOX®O2 Operating Manual
English
the delivery device.
Returns procedure
PMP/B
If the equipment requires servicing, please
contact NOxBOX Ltd’s Customer Repairs
department before returning any goods. If
the equipment was not purchased directly
from NOxBOX Ltd, please contact the local
distributor.
When flashing, the pump or sample path has
a blockage.
●● Check the sample line is not kinked,
crushed or trapped.
●● If no visible external blockage present,
replace the patient sample line with a new
line.
●● If still blocking, replace the patient filter
after the water trap
●● Should replacing external components fail
to resolve the blockage issue, please refer
to your qualified service engineer. Internal
filters may need replaced.
2
H2O
When flashing, water trap is full. To prevent
damage occurring to the NOxBOX®O2 monitor
and its sensors, drain the water trap using
a suitable syringe (See fig. 6). Drainage
syringes are supplied by NOxBOX Ltd or your
distributor.
3
BATlow
When flashing, battery is low. Plug
NOxBOX®O2 unit into an appropriate medical
grade power source to resolve.
●● The Customer Repairs department will
issue a Returns Number once the monitor
serial number and a description of the
fault are supplied.
●● State the Returns Number when returning
the monitor and ensure that full details,
including telephone and fax numbers, are
clearly provided.
●● NOxBOX Ltd advises using a courier
service when returning monitors.
●● Confirmation will be issued when goods
are received.
●● An Engineer’s Report and a quotation
for the repair will be sent following
investigation. This includes an
Authorisation Form.
●● If the monitor is still in warranty, NOxBOX
Ltd will repair it and return it with an
Engineer’s Report, free of charge. If
the monitor is found to simply require
calibrating, a fee will be charged.
●● If out of warranty, complete the
Authorisation Form included with the
quotation to proceed with the repair
or calibration. Ensure that an Official
Purchase Order Number is included, and
return the instrument to NOxBOX Ltd .
Contact the Customer Repairs department
Specialist if you have any queries.
●● If it is decided not to proceed with the
repair, a handling fee will be charged.
Ensure that the completed Authorisation
Form is returned to NOxBOX Ltd with an
Official Purchase Order Number.
Figure 6: NOxBOX O2 water trap and syringe
®
20
●● The equipment will be returned as soon
as NOxBOX Ltd has received all relevant
paperwork. A carriage fee will be charged
if the monitor is out of warranty.
English
NOxBOX®O2 Operating Manual
Spares
Part number
Description
NOXO2-NO
Replacement NO sensor for NOxBOX®O2
NOXO2-NO2
Replacement NO2 sensor for NOxBOX®O2
NOXO2-O2
Replacement O2 sensor for NOxBOX®O2
NOXO2-SCS
Sample conditioning system for NOxBOX®O2
NOXO2-NAF
Nafion tubing for NOxBOX®O2
NOX02WT-COMPLETE
Water trap
FIX053
Power lead (UK)
FIX054
Power lead (EU)
NOX-Y-CAL
Calibration system (Y-piece and male luer)
034-18-00520-V
Calibration gas (25ppm NO in N2) 34-litre disposable cylinder
034-20-01010-V
Calibration gas (10ppm NO2 in air) 34-litre disposable cylinder
REGSS-1.0-V
Calibration regulator, pressure guage and flow outlet
SCCG
Carry case for cans and regulators
NOXKIT-V
NOXKIT-NEONATE
NOXKIT-CHILD
NOXKIT-ADULT
A selection of connectors to attach NOxBOX®O2 to a ventilator
RECYCLER-V
Puncture tool for recycling empty cylinder
WIPE-V
Instrument Cleansing Wipes
NOXO2-FIL
Protective Filter
NOXO2-INT-FIL
Scavenging Filter
NOXO2-SL-2.5M
2.5m Sample line
NOXO2-PATIENT
2.5m sample line, protective filter, water trap emptying syringe
NOXO2-PATIENT-COMP
2.5m sample line, water trap, protective filter, water trap emptying syringe
CON139
Luer fitting for NOxBOX®O2 water trap filter
CON136
Luer fitting for NOxBOX®O2 water trap sample line
NOXO2-BAT
Replacement battery unit for NOxBOX®O2
The above spares are available from NOxBOX Ltd, UK. For spares availability in all other countries,
contact your local distributor. It is recommended that only NOxBOX Ltd spares are used.
Warranty
NOxBOX Ltd warrants the NOxBOX®O2
(excluding batteries) to be free of defects in
materials and workmanship for a period of
twenty four months from the date of shipment.
NOxBOX Ltd’s sole obligation under this
warranty is limited to repairing or replacing, at
its choice, any item covered under this warranty
when such an item is returned intact, prepaid, to
NOxBOX Ltd or your local representative.
Note: Sensors are guaranteed for a period of
twelve months from the date of shipment from
NOxBOX Ltd.
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These warranties are automatically invalidated if
the products are repaired, altered, or otherwise
tampered with by unauthorised personnel,
or have been subject to misuse, neglect or
accident.
Do not dispose of any electronic equipment
or batteries in domestic waste. At the end of
the product’s life, contact NOxBOX®O2 or its
distributor for disposal instructions.
Single use consumables
and accessories should
be disposed of in line with
the local clinical waste
guidelines.
21
Notes
Notes
Station Road, Harrietsham,
Maidstone, Kent,
ME17 1JA, England
Tel: +44 (0)1622 854868
Fax: +44 (0)1622 854860
Email: [email protected]
www.noxboxltd.com
Issue 10– February 2016 - Part No: LAB463
© NOxBOX Ltd
NOxBOX Ltd reserves the right to change or update this literature without prior notice. Registered in
England and Wales. Registered No.: 9563860