Noxbox
Noxbox
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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.
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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
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.
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
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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.
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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)
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
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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.
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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:
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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
The sample gas monitored values are displayed in the upper section of the screen in Fig. 3.
The lower section of the screen displays alarm settings and messages
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 ---
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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).
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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
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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:
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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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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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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: [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