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NOxBOX O2 ®

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NOxBOX®O2 Operating Manual
English

Contents
1 Intended use 3
2 Safety 3
Basic Safety Recommendations 3
3 Safe Operation Notes 3
4 Environment 4
5 Warnings 6
6 Important Notices 6
Single-Use 6
Cleaning 6
Maintenance and Storage 7
Contraindications 7
7 Specification 8
Symbols 8
8 Instrument layout 9
9 Operation 10
Pre-use checks 10
Setting up the NOxBOX®O2 10
Connecting to the Patient Circuit 10-11
Switching Off 12
8 ®
NOxBOX O2 Display 13
10 Alarms 14
Setting Alarms 14
11 Calibration 15
Sensor Zero 15
NO Calibration 16
NO2 Calibration 17
O2 Calibration 17
12 Troubleshooting 18
Resolving Alarms 18-20
13 Returns Procedure 20
14 Spares 21
15 Warranty 21

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Intended use required by local codes or manufacturer
recommendations. Never bypass safety devices,
and never operate the equipment outside its
The NOxBOX®O2 is intended for use by
specified limits.
healthcare professionals for monitoring the
levels of nitric oxide (NO), nitrogen dioxide Ensure safe maintenance and repair - Only
(NO2) and oxygen (O2) delivered to a patient qualified personnel should repair the equipment.
undergoing INO inhaled nitric oxide therapy). Ensure equipment is maintained according to
the manufacturer’s recommendations, including
Safety any calibration or inspection routines.

Do not operate this equipment until you Safe Operation Notes


have read and understood the operating,
maintenance and safety instructions included in To avoid electric shock, this equipment must be
this manual and any manuals supplied with the connected to a mains supply with a protective
INO therapy delivery system being used. earth.
Only trained and responsible personnel should The operator should not touch the patient
work with or around this equipment. whilst in contact with either the computer or
the USB connector parts. The NOxBOX®O2
To avoid serious injury, pay attention to all
should only be connected to a computer that is
precautionary labels attached to equipment,
manufactured in accordance with EN60950 -
cylinders, containers and boxes prior to start-up.
Safety of information technology equipment.
Do not remove or obscure any label. If a label
is missing, becomes worn, or is difficult to read, Ensure the monitor is out of reach of the patient
replace it with a new one. Product labels for the when in operation, at a distance of at least 1.5m
NOxBOX®O2 are available from your distributor Please do not attempt to modify the equipment
or NOxBOX Ltd representative. in any way or use accessories not specified
by the manufacturer. Any attempt to do so will
Advice to the responsible organisation that invalidate the warranty and may affect the safety
the assembly of medical equipment systems of the device.
and modifications during the actual service
The monitor is not suitable for use in an oxygen
life require evaluation to the requirements of
rich environment.
EN60601-1:2006.
The monitor uses a sampling tube that may
Basic Safety come into contact with the patient’s skin during
normal procedures. For this reason, the sample
Recommendations tube is considered as an Applied Part but it is
To prevent formation of unsafe atmospheres, safe to use and offers no risks to the patient or
ensure that properly engineered ventilation user.
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.
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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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 Compliance level Electromagnetic
Test level environment
guidance
Electrostatic ±6 kV contact ±6 kV contact Floor should be wood,concrete, or
discharge (ESD) ceramic tile. If floors are covered
± 8 kV air ± 8 kV air with synthetic material, the relative
IEC 61000-4-2 humidiity should be at least 30%.

Electrical fast ±2 kV for power ±2 kV for power Mains power quality should be that
transient/burst supply lines supply lines of a typical commerical
and/or hospital enviroment.
IEC 61000-4-4 ±1 kV for input/
output lines
Surge ±1 kV ±1 kV Mains power quality should be
line to line line to neutral that of a typical commercil and/or
IEC 61000-4-5 hospital enviroment
±2 kV ±2 kV
line to earth line to earth
<5 % U Mains power quality should be
(>95 % dip in UT) that of a typical commercial and/or
for 0.5 cycle 60 % dip to x 5 hospital environment.
cycles If the user of the NOxBOX®O2
Voltage dips, short 40 % U requires continued operation
interruptions and (60 % dip in UT ) during power mains interruption,
voltage variations for 5 cycles it is recommended that the
on power supply
NOxBOX®O2 be powered from
IEC 61000-4-11 70 % U an uninterruptible power supply or
(30% dip in UT) battery.
for 25 cycles
100% dip for 5s
<5 % U
(95 % dip in UT) for 5
cycles
Power frequency 3 A/m 3 A/m Power frequency magnetic
(50/ 60 Hz) fields should be at levels
magnetic field characteristic of a typical location
IEC 61000-4-8 in a typical commercial or hospital
environment.
Note: UT is the A.C. mains voltage prior to application of the test level.

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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 IEC 60601 Compliance Electromagnetic environment– guidance


Test level level
3 V rms Portable and mobile RF communications equipment
150 kHz ~ should be used no closer to any part of the
80MHz outside 3 V rms NOxBOX®O2 including cables, than the recommended
Conducted RF ISM bands* separation distance calculated from the equation
IEC 61000-4-6 appropriate to the frequency of the transmitter.
10 V rms
150 kHz ~ 10 V/m Interference may occur in the vicinity of equipment
marked with he following symbol:
80MHz in ISM
Radiated RF bands*
IEC 61000-4-3
10 V rms 80MHz to
80 kHz ~ 2.5GHz
2.5 GHz
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 Compliance Electromagnetic environment - guidance


The NOxBOX®O2. uses RF energy only for its internal
RF emissions function. Therefore, its RF emissions are very low and are
Group 1
CISPR 11 not likely to cause any interference in nearby electronic
equipment.
The NOxBOX®O2. is suitable for use in all establishments,
RF emissions including domestic establishments and those directly
Class B
CISPR 11 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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Warnings Important Notices


DANGER: Poisonous gases can be fatal if
inhaled, even in very small quantities. Provide
Single-Use
adequate ventilation and appropriate personal The following items listed and approved for
protective equipment (PPE). use with the NOxBOX®O2 are single-patient
use only. These items are not reprocessible
This equipment monitors poisonous gases.
and should be properly disposed of after use
The Threshold Limit Value (TLV) for each gas
according to local guidelines for such items:
refers, in general, to airborne concentrations
at or below which nearly all workers may be ●● The protective filter
repeatedly exposed without adverse effects.
The TLVs for the specialty gases used with this ●● The sample line
equipment should be stated on the cylinder ●● The water trap drainage syringe
body labels and the MSDSs (Material Safety
1
Data Sheets) for each gas.
Nitric Oxide (NO): Cleaning
At room temperature and atmospheric Wipe the instrument and external surfaces with
pressure, NO is a colourless, odourless, toxic, a product specifically developed for the purpose.
non-flammable gas. It will readily combine with NOxBOX Ltd provides Instrument Cleansing
atmospheric oxygen to form NO2. Wipes.

Nitrogen Dioxide (NO2): ●● Never use alcohol, cleaning agents


NO reacts with atmospheric oxygen to produce containing alcohol, or other organic solvents
NO2; the NO2 may react further with water to to clean the monitor. Vapours from such
produce nitric and nitrous acid which can both chemicals will damage the internal sensors.
be extremely corrosive. The human lungs
●● Under no circumstances should the
are a wet environment, so inhalation of this
instrument be immersed in or splashed with
extremely toxic gas can have severe effects and
every reasonable measure should be made to liquid.
minimise exposure to NO2. ●● NOxBOX®O2 is not suitable for sterilization.
Current UK HSE guidelines recommend ●● To clean the water trap, use any of the
following the Chemical Hazard Awareness three fluid path luer lock ports to introduce
Notice (CHAN) for nitrogen oxides (including cleaning fluid. Do not use any alcohol or
NO and NO2) state that time weighted average
organic-based solvents to clean the water
(TWA) over eight hours should not exceed
1ppm. trap as this may damage the sensors. Do
not submerge the water trap in liquids as
Nitrogen (N2): this may cause damage to the electrical
Nitrogen gas is an asphyxiant. A major sensor.
component of air, it is colourless and odourless ●● Ensure all cleaning substances are
at room temperature. Care should be taken to
thoroughly drained and removed from the
avoid excessive release of Nitrogen into the
atmosphere without adequate ventilation to water trap before use.
protect the user from a low-oxygen atmosphere
being created.

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Maintenance and Storage
●● Calibration should be checked regularly, NOxBOX Ltd will make available on request
in accordance with the instructions in this circuit diagrams, components part lists,
manual (see “Calibration” section, Page 13). descriptions, calibration instructions, or
other information which will assist the user’s
●● Temperature may affect the accuracy of appropriately qualified technical personnel
the NOxBOX®O2. The instrument should to repair those parts of equipment which are
be calibrated at the temperature at which it designed by the manufacturer as repairable,
is expected to be used. If the NOxBOX®O2 following service training.
is used at a lower temperature than when
it was calibrated, readings may be lower;
Contraindications
if used at a higher temperature than when ●● Refer to your NO drug manufacturer’s
calibrated, readings may be higher. instructions for use, safety and warning
●● The nitric oxide sensor is cross-sensitive statements regarding contraindications for
to nitrogen dioxide, but not significantly the application of nitric oxide gas for the
enough to affect the unit during use. purpose of INO therapy.

●● Prior to storage, ensure that the ●● NO gas is toxic at high concentrations and
NOxBOX®O2 is correctly decommissioned appropriate continuous monitoring of the
following use. See “Operation” section, applied patient dose concentration should
“Switching Off” Page 10. be used.

●● Store the NOxBOX®O2 connected to ●● WARNING: Sudden cessation of INO


the mains supply to prevent the battery therapy can cause complications such as
losing charge. In the event that the battery rebound hypoxia to occur.
discharges, the sensors will no longer be
biased.
●● 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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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
Type of protection against electric shock:
Internally Powered Equipment
Direct Current
Class I equipment; (earthed)
Degree of protection against electric shock: iNO therapy can be hazardous if not
Type BF applied part Caution applied correctly.
Please refer to the warnings and
safety notes in this manual
Degree of safety of application in the prescence of
Degree of protection against ingress of liquid:
a flammable anaesthetic mixture with air oxygen or
IPXO - not protected against water ingress
nitrous oxide: Equipment not suitable for use in the
presence of flammable mixtures. Consult instructions for use

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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 IEC power socket 230v


(115v, optional)
5 Manual zero
16 Anti-surge fuses
6 NO/NO2/O2 calibration adjusters
7 17 On/off Switch
LCD screen

8 18 Water trap
Mute button
9 19 Luer lock release valve
Charging LED
10 20 Protective filter
Water trap sensor connector
11 21 USB (optional)
Zero reference
22 Handle

1 3 22

6 21
11
10 12

20
5
2 4 14

19
15

16
7 17 18 13

9
8

! CAUTION: Ensure that the mains plug


is not obstructed to facilitate easy removal from
the mains socket.

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Operation 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
The NOxBOX®O2 is supplied assembled and
20.9% (±0.2%) absolute.
ready for use. Prior to shipment, all units are
zeroed with pure air and calibrated with certified 4. If the unit is out of calibration, it must be
NO in N2 and NO2 in air. calibrated prior to use to ensure reliable
reading of the dose. To calibrate the
Pre-use checks unit, follow the procedure described in
●● Ensure that the water-trap is empty before Calibration, Page 13.
use. 5. Adjust the four gas alarms (described
●● If the water trap needs emptying, use the under Alarms section, Page 12) at levels
supplied drainage syringe by screwing appropriate to facilitate best monitoring
onto the water trap Luer lock on the rear of and awareness for the individual patient
instrument (see Instrument layout, page 7) treatment.
and drain the water if required.
6. The NOxBOX®O2 is now ready to connect
●● Calibration is recommended once a week to the patient circuit.
during use, or once a month during storage.
NOxBOX Ltd recommends that the unit is Connecting to the Patient
calibrated prior to use if calibration has not
been carried out within these timescales.
Circuit
Follow the instructions for calibration on 1. Install a new patient filter to the exit of
page 13. the water trap. Twist the blue luer collar
on the water trap exit to the filter inlet
●● Checking the function of this critical care
(filter inlet side printed with FIL042A, see
piece of equipment is important and these
Fig. 1). Twist the blue luer collar on the
instructions must be adhered to.
green tubing to the filter outlet (see Fig. 1).
Setting up the NOTE: Filter is a single-patient use item

NOxBOX®O2 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

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2. 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 2

ventilator circuits.

3. 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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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.

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NOxBOX®O2 Display

A
NO: 0.0PPM
B 0.0 NO2
PPM 20.9 O2
% C
25.0
NOHi = 30/6 NOLo = 00.0 O2low = 16.0
NO2hi = 2.0
12.0 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
INDICATION RANGE

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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Alarms
In the event of an alarm, the display will flash to Setting the NO2 high alarm
indicate which alarm has been triggered and an
●● Adjust “NO2 hi” control dial until NO2
audible alarm tone will sound. The NOxBOX®O2
hi displayed on the screen reaches the
monitor has a mute button located directly under
appropriate value and is stable.
the display, press and hold for 3 seconds to
mute the alarm for approx. 2 minutes. Setting the O2 low alarm
●● Adjust “O2 low” control dial until O2 low
Setting Alarms
displayed on the screen reaches the
The four gas level alarms are user set via the appropriate value and is stable.
control dials located on the right hand side of
●● NOTE: minimum setting is 16.0%
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.

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Calibration
Calibration of the NOxBOX®O2 should be carried ●● The NOxBOX®O2 will automatically zero
out once a week during use and once a month as it is switched on, wait until the screen
during storage. displays the normal monitoring screen
before calibrating.
Refer to the safety notices on handling toxic and
asphyxiating gases at the front of this manual. ●● If the unit is already on prior to commencing
Refer to the individual gas MSDSs for full safety calibration, perform a manual zero by
data for the gas being used. pressing the button located next to the
The area used to calibrate the NOxBOX®O2 alarm adjustment dials on the right of the
should be well ventilated and appropriate PPE monitor. The zero process should take
such as safety goggles should be worn. Use an approximately 2 minutes.
ambient environmental monitor for NOx gases
such as the NOxAIR personal alarms available 1
from NOxBOX Ltd during calibration. NOTE: During the zero, the screen will display
“zeroing” (Fig. 4) and display two sets of
Sensor Zero numbers below this. These numbers are for
IMPORTANT: Before carrying out any calibration diagnostic purposes should there be a problem
procedure, it is essential for the NOxBOX®O2 to with the calibration procedure, and can help the
complete a full zeroing process which sets the technical support team diagnose any issues that
baseline reading for the sensors. No special gas may have occurred with the monitor.
connections are required.

ZEROING
10 58

Figure 4: NOxBOX®O2 display, showing Zeroing

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IMPORTANT: Ensure the NOxBOX®O2 unit ●● Once the NO value displayed is stable, the
has been stored correctly on charge prior to display reading can be adjusted to match
calibration. If the unit battery has been allowed the value of the certified calibration gas.
to run down, the sensors may lose bias and the
Using the calibration screwdriver supplied,
unit must be connected to the mains and left on
locate the tip of the screwdriver into the
charge for a minimum of 6 hours to ensure the
sensor is fully biased prior to calibration. “NO span” potentiometer screw located on
the right side of the monitor. Gently turn
Nitric oxide (NO) Calibration the screw to adjust the displayed value as
IMPORTANT: Ensure the NOxBOX®O2 readings appropriate.
are at or near expected baseline values (NO =
0.0, NO2 = 0.0, O2 = 20.9%) before performing ●● Turn the control valve on the regulator off to
the NO calibration procedure. If following on stop the flow of NO gas.
from another sensor calibration, this process ●● Disconnect the calibration line from the
should take no more than 2 – 3 minutes. water trap.
Calibration Gas: A certified gas cylinder
●● Disconnect the regulator from the calibration
containing 25ppm NO balanced in nitrogen,
supplied by NOxBOX Ltd. 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 Figure 5: Calibration Procedure
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.

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Nitrogen dioxide (NO2) ●● Disconnect the calibration line from the
water trap.
Calibration
●● Disconnect the regulator from the calibration
IMPORTANT: Ensure the NOxBOXO2 readings
are at or near expected baseline values (NO = cylinder
0.0, NO2 = 0.0, O2 = 20.9%) before performing Oxygen (O2) calibration
the NO2 calibration procedure. If following on
from another sensor calibration, this process IMPORTANT: Ensure the NOxBOX®O2
should take no more than 2 – 3 minutes. readings are at or near expected baseline
Calibration Gas: A certified gas cylinder values (NO = 0.0, NO2 = 0.0, O2 = 20.9%)
containing 10ppm NO2 balanced in air, supplied before performing the O2 calibration
by NOxBOX Ltd. procedure. If following on from another sensor
3 calibration, this process should take no more
than 2 – 3 minutes.
Procedure:
Calibration Gas: Scrubbed ambient air at
●● Attach the stainless steel miniature 20.9%
regulator, supplied by NOxBOX Ltd to the
gas cylinder valve. Ensure the control valve
Procedure:
is closed.
●● Allow the NOxBOX®O2 readings to
●● The outlet of the regulator should be
return to the normal baseline values and
attached to the supplied calibration line
stabilise.
clear plastic NOX-Y-CAL tubing. This tubing
●● Using the calibration screwdriver supplied,
has a y-piece exhaust to ensure that the
locate the tip of the screwdriver into the
sensors receive the correct level of gas and
“O2 span” potentiometer screw located on
are not damaged by over-pressure.
the right side of the monitor. Gently turn
●● Connect the luer on the free-end of the the screw to adjust the displayed value as
calibration tubing to the inlet luer of the appropriate.
water trap on the NOxBOX®O2.
●● 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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Troubleshooting being a fault with this monitor.


●● If all above steps have not resolved the
Resolving Alarms issue, consider replacing the NO supply
cylinder.
In the first instance of an alarm sounding,
the effect on the patient, their condition and IMPORTANT: the NO gas flow levels should
treatment is the overriding priority. Check and not deviate substantially (e.g. > +/- 30%) from
safeguard patient condition before attending to the guideline settings recommended for the
the monitor. patient vent flow and NO supply cylinder.
Rule out a fault with the monitoring equipment
The following advice should help resolve the
before substantially altering the NO flow from
alarm condition. If the advice herein fails,
the delivery device.
contact your service engineer for assistance. It
may be appropriate to replace a malfunctioning
monitor in worst case. NOLo
For any on-going issues, or to obtain more ●● Check patient is still breathing.
in-depth technical assistance on these products, ●● Check inspiratory ventilator flow is present
please contact NOxBOX Ltd’s technical support and free from leaks or broken connections.
at www.noxboxltd.com and click on “Technical
●● Check connection of NO supply line from
support”.
delivery device to ventilator circuit is free
from leaks.
ALARM / ACTION: ●● If O2low alarm is sounding at the same
1 time, there is likely to be a leak in the patient
sample path. Check connection of patient
NOHi
sample line connection to the ventilator and
●● Check patient is still breathing. NOxBOX®O2 is free from leaks.
●● Check inspiratory ventilator flow is ●● If PMP/B alarm is sounding at the same
present and free from leaks or broken time, the low NO reading may be due to
connections. a kink or blockage in the sample path.
●● Check NO delivery device flow setting is Resolve this alarm and monitor system for
correct for patient ventilator flow and NO 2 minutes to see if the NO level reading
supply cylinder concentration. recovers.
●● If appropriate, reduce NO flow from ●● If NO2hi alarm is sounding at same time,
delivery device and allow 2 minutes the delivery gas system may have suffered
before re-assessing NO levels. NOTE: oxidisation. This can be resolved by purging
the 2 minutes allows the full impact of the delivery system lines. Refer to the
any changes to be recorded. delivery system manual for instructions and
●● Perform a manual zero on the warnings on purging.
NOxBOX®O2 by pressing the zero button ●● Check NO delivery device flow setting is
on the right side of the monitor. NOTE: correct for patient ventilator flow and NO
this process takes approximately 2 supply cylinder concentration.
minutes. ●● If appropriate, increase the NO flow from
●● If NO reading is still high, replace the delivery device and allow 2 minutes
monitor for another unit to exclude there before re-assessing NO levels. NOTE:

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NOxBOX®O2 Operating Manual

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the 2 minutes allows the full impact of any for 2 minutes to see if the O2 level reading
changes to be recorded. recovers.
●● Perform a manual zero on the NOxBOX®O2 ●● Perform a manual zero on the NOxBOX®O2
by pressing the zero button on the right side by pressing the zero button on the right side
of the monitor. NOTE: this process takes of the monitor. NOTE: this process takes
approximately 2 minutes. approximately 2 minutes.
●● If NO reading is still high, replace the ●● If O2 reading is still low, replace the monitor
monitor for another unit to exclude there for another unit to exclude there being a
being a fault with this monitor. fault with this monitor.
●● If all above steps have not resolved the
issue, consider replacing the NO supply NO2hi
cylinder.
IMPORTANT: NO2 is a highly toxic pulmonary
IMPORTANT: the NO gas flow levels should irritant. Remedial action for high NO2 levels
not deviate substantially (e.g. > +/- 30%) from should be implemented immediately to protect
the guideline settings recommended for the the patient.
patient vent flow and NO supply cylinder. Rule
●● Check patient is still breathing.
out a fault with the monitoring equipment before
substantially altering the NO flow from the ●● Check inspiratory ventilator flow is present
delivery device. and free from leaks or broken connections.
●● Check NO delivery device flow setting is
correct for patient ventilator flow and NO
O2low
supply cylinder concentration.
●● Check patient is still breathing.
●● If appropriate, reduce NO flow from delivery
●● Check inspiratory ventilator flow is present device and allow 2 minutes before re-
and free from leaks or broken connections. assessing NO2 levels. NOTE: the 2 minutes
●● Check NO delivery device flow setting – at allows the full impact of any changes to be
high flow rates, there can be significant recorded.
volumes of N2 gas being delivered into the ●● Perform a manual zero on the NOxBOX®O2
patient ventilator lines which can dilute by pressing the zero button on the right side
the O2 levels. Adjust relevant equipment of the monitor. NOTE: this process takes
settings to correct for this effect if required. approximately 2 minutes.
Allow 2 minutes after adjusting any levels
●● If NO2 reading is still high, replace the
before reassessing the monitored gas
monitor for another unit to exclude there
values.
being a fault with this monitor.
●● If NOLo alarm is sounding at the same time,
●● If all above steps have not resolved the
there is likely to be a leak in the patient
issue, consider replacing the NO supply
sample path. Check connection of patient
cylinder.
sample line connection to the ventilator and
NOxBOX®O2 is free from leaks. IMPORTANT: The NO gas flow levels should
not deviate substantially (e.g. > +/- 30%) from
●● If PMP/B alarm is sounding at the same
the guideline settings recommended for the
time, the low O2 reading may be due to
patient vent flow and NO supply cylinder.
a kink or blockage in the sample path.
Rule out a fault with the monitoring equipment
Resolve this alarm and monitor system
before substantially altering the NO flow from
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the delivery device.


Returns procedure
PMP/B If the equipment requires servicing, please
contact NOxBOX Ltd’s Customer Repairs
When flashing, the pump or sample path has department before returning any goods. If
a blockage. the equipment was not purchased directly
●● Check the sample line is not kinked, from NOxBOX Ltd, please contact the local
distributor.
crushed or trapped.
●● If no visible external blockage present, ●● The Customer Repairs department will
issue a Returns Number once the monitor
replace the patient sample line with a new
serial number and a description of the
line. fault are supplied.
●● If still blocking, replace the patient filter ●● State the Returns Number when returning
after the water trap the monitor and ensure that full details,
●● Should replacing external components fail including telephone and fax numbers, are
clearly provided.
to resolve the blockage issue, please refer
to your qualified service engineer. Internal ●● NOxBOX Ltd advises using a courier
service when returning monitors.
filters may need replaced.
●● Confirmation will be issued when goods
2 are received.
H2O ●● An Engineer’s Report and a quotation
for the repair will be sent following
When flashing, water trap is full. To prevent
investigation. This includes an
damage occurring to the NOxBOX®O2 monitor Authorisation Form.
and its sensors, drain the water trap using
●● If the monitor is still in warranty, NOxBOX
a suitable syringe (See fig. 6). Drainage Ltd will repair it and return it with an
syringes are supplied by NOxBOX Ltd or your Engineer’s Report, free of charge. If
distributor. the monitor is found to simply require
3 calibrating, a fee will be charged.
●● If out of warranty, complete the
BATlow Authorisation Form included with the
When flashing, battery is low. Plug quotation to proceed with the repair
NOxBOX®O2 unit into an appropriate medical or calibration. Ensure that an Official
Purchase Order Number is included, and
grade power source to resolve.
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.
●● The equipment will be returned as soon
Figure 6: NOxBOX O2 water trap and syringe
® as NOxBOX Ltd has received all relevant
paperwork. A carriage fee will be charged
if the monitor is out of warranty.

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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 A selection of connectors to attach NOxBOX®O2 to a ventilator
NOXKIT-NEONATE
NOXKIT-CHILD
NOXKIT-ADULT
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 These warranties are automatically invalidated if
the products are repaired, altered, or otherwise
NOxBOX Ltd warrants the NOxBOX®O2
tampered with by unauthorised personnel,
(excluding batteries) to be free of defects in
or have been subject to misuse, neglect or
materials and workmanship for a period of
accident.
twenty four months from the date of shipment.
NOxBOX Ltd’s sole obligation under this Do not dispose of any electronic equipment
warranty is limited to repairing or replacing, at or batteries in domestic waste. At the end of
its choice, any item covered under this warranty the product’s life, contact NOxBOX®O2 or its
when such an item is returned intact, prepaid, to distributor for disposal instructions.
NOxBOX Ltd or your local representative.
Single use consumables
Note: Sensors are guaranteed for a period of and accessories should
twelve months from the date of shipment from be disposed of in line with
NOxBOX Ltd. the local clinical waste
guidelines.

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Notes
Notes
Station Road, Harrietsham,
Maidstone, Kent,
ME17 1JA, England
Tel: +44 (0)1622 854868
Fax: +44 (0)1622 854860
Email: ask@noxboxltd.com
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

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