Bedfont NOxBOX mobile Quick start guide

Technical Guide: Issue 5.0 July 2015
saving lives, one breath at a time
NOxBOXi
®
www.bedfont.com
(Software V.17.0)

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Table of Contents
1 User Responsibility...........................................................................................................................................
2 Safety ..............................................................................................................................................................
2.1 Basic Safety Recommendations ...............................................................................................................
Basic Hazards .................................................................................................................................................
2.1.1 Asphyxiation ..........................................................................................................................
2.1.2 Electrocution..........................................................................................................................
Pressure ..........................................................................................................................................................
2.1.3 Toxicity ...................................................................................................................................
2.1.4 Poisons ..................................................................................................................................
2.2 Hazard Labels ....................................................................................................................................
2.3 Cleaning Precautions .........................................................................................................................
2.4 Electromagnetic Immunity...................................................................................................................
2.5 Network Connections .........................................................................................................................
2.6 Applied Parts ......................................................................................................................................
2.7 Isolation from Mains............................................................................................................................
3 Equipment Description ....................................................................................................................................
3.1 Intended Use.......................................................................................................................................
 3.2 Specication&Environment...............................................................................................................
 3.3 Denitions,AbbreviationsandIcons...................................................................................................
  3.3.1 Abbreviations..........................................................................................................................
  3.3.2 Denitions..............................................................................................................................
  3.3.3 IconsOverview.......................................................................................................................
3.3.4 Rear Label Symbols...............................................................................................................
3.3.5 Front Label Symbols .............................................................................................................
3.3.6 Power Supply Symbols...........................................................................................................
3.3.7 Accessory Label Symbols .....................................................................................................
  3.3.8 ManualOverrideFlowSectorValveMarkings.......................................................................
3.4 System Components...........................................................................................................................
3.4.1 NOxBOXi System Features.....................................................................................................
3.5 NOxBOXi EffectonVentilatorCircuit..................................................................................................
3.5.1 Oxygen Dilution .....................................................................................................................
  3.5.2 MeasuredMinuteVolume......................................................................................................
  3.5.3 TriggerSensitivity..................................................................................................................
  3.5.4 MaximumNODoseDelivery..................................................................................................
4 Installation ......................................................................................................................................................
4.1 Unpacking Instructions .......................................................................................................................
 4.2 AssembleDeliveryUnittoTrolley.......................................................................................................
4.3 Setup Instructions................................................................................................................................
4.4 Connecting NO Gas Cylinders ...........................................................................................................
4.5 System Test Setup..............................................................................................................................
5 Patient Circuit Setup........................................................................................................................................
5.1 NOxFlow..............................................................................................................................................
5.2 System Test Circuit..............................................................................................................................
 5.3 Ventcircuitexample1.........................................................................................................................
 5.4 Ventcircuitexample2..........................................................................................................................
5.5 Manual bagging and manual mode.....................................................................................................
5.5.1 Setup......................................................................................................................................
  5.5.2 Self-inating............................................................................................................................
  5.5.3 HyperInation........................................................................................................................
5.5.4 Neopuff Resuscitator..............................................................................................................
6 Operation..........................................................................................................................................................
 6.1 GasDeliveringSystem........................................................................................................................
6.2 Monitoring System...............................................................................................................................
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6.3 Touch Screen Interface.....................................................................................................................
  6.3.1 BriefNavigationGuide.........................................................................................................
6.3.2 On-screen User Guide.........................................................................................................
6.4 System Tests.....................................................................................................................................
 6.5 ConnectingtoPatientVentilator.......................................................................................................
6.6 Dose Entry and Alarm setting............................................................................................................
6.7 Main Screen Display..........................................................................................................................
6.7.1 Detailed areas of main screen..............................................................................................
  6.7.2 TabbedNavigation................................................................................................................
6.7.3 Change dose and Alarms ....................................................................................................
6.7.4 Standby Mode .....................................................................................................................
6.8 Screen lock .......................................................................................................................................
6.8.1 Setting the Screen lock format .............................................................................................
6.9 Alarms.......................................................................................................................................................
6.9.1 Red Banner Alarms...............................................................................................................
6.9.2 Gas Supply Alarms ..............................................................................................................
  6.9.3 CalibrationOverdue.............................................................................................................
6.9.4 Other Alarms and System Alerts .........................................................................................
 6.10 ZeroCalibrationDuringDelivery........................................................................................................
6.11 User Settings Screen.........................................................................................................................
Changing Display Language.............................................................................................................
  Changevolumeandbrightness.........................................................................................................
Access Zero Calibration ...................................................................................................................
Access the Calculator........................................................................................................................
  AccesstoServiceEngineerArea......................................................................................................
 6.12 ManualOverride................................................................................................................................
6.12.1 Determine Correct Flow Settings.........................................................................................
6.12.2 Using the Printed Look-up Tables ........................................................................................
  6.12.3 EngageManualOverride:...................................................................................................
  6.12.4 ManualOverrideFlowSelector:ApproximateNOowvalues............................................
6.13 Shutdown..........................................................................................................................................
7 Maintenance and Repair................................................................................................................................
7.1 Periodic Maintenance .......................................................................................................................
7.2 System Settings ...............................................................................................................................
7.3 Cleaning the NOxBOXi System.........................................................................................................
7.4 Calibration.........................................................................................................................................
7.5 System Replacement Parts ..............................................................................................................
7.6 Disposable System Accessories ......................................................................................................
7.7 Warranty.............................................................................................................................................
8 Alarms Troubleshooting..................................................................................................................................
8.1 Alarm Priorities..................................................................................................................................
 8.2 Noticationsatswitchon...................................................................................................................
8.3 Alarm Priority- Alarms during therapy................................................................................................
8.4 General troubleshooting....................................................................................................................
 9 VentilatorManagement.....................................................................................................................
 9.1 VentilatorCompatibilitylist................................................................................................................
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5
1 USER RESPONSIBILITY
The NOxBOXi product will perform in accordance with the description detailed in this
documentandaccompanyingguidesand/orlabelswhenassembled,operated,stored,
maintainedandrepairedinaccordancewiththeinstructionsprovided.
Thisproductmustbecheckedandcalibratedin-linewiththeoutlinedservice
schedule recommendations. A product found to be faulty should not be used. Any
partsoraccessoriesthatarebroken,damaged,missing,obviouslyworn,distortedor
contaminated should be replaced immediately.
Intheeventoftheproductrequiringrepairorreplacement,itisrecommendedthatthe
customerrstcontactstheirdistributorortechnicalsupportservicefortheNOxBOXi. It
isessentialthatonlyapprovedcomponentsareusedtoreplaceorrepairanypartofthe
NOxBOXi,inaccordancewiththemanufacturer’swritteninstructions.Theproductmust
notbealteredwithoutpriorwrittenapprovalfromtheTechnicalSupportdepartmentof
BedfontScienticLtd.
Thisdevicehasbeendesignedandconstructedwithhighqualitycomponentstoensure
accuracy,reliabilityandcompatibility,ifthirdpartycomponentsareinstalledwithoutprior
consentfromBedfont,Bedfontwillnotbeliableforanyincidentwhichmayoccurasa
resultofthis.Thismayalsoinvalidateyourwarranty.
The product user bears sole responsibility for any malfunction resulting from improper
use,faultymaintenance,improperrepair,damageorunauthorizedalterationbyany
sourcenotauthorizedtodosobyBedfontScienticLtd.
Throughoutthisdocument,therearehighlightedareascontaining
information,warningsordangernotications:
Information: Statement contains important information highlighted for user
awareness
Caution:Statementcontainsinformationalertsthatcouldhelpaverta
problem occurring.
Warning: Statement contains important information that may affect the
safety of user and/or patient if manual instructions are not followed.
Danger: Statement contains important information that has direct
bearing on the safety of user and/or patient if manual instructions are not
followed.

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WARNING:Toavoidseriousinjury,payattentiontoallprecautionarylabels
attachedtoequipment,cylinders,containers,andboxespriortostartup.Donot
removeorobscureanylabel.Ifalabelismissing,becomesworn,orisdifcult
toread,replaceitwithanewone.LabelsareavailablefromyourBedfont
representative.
This chapter contains information to promote safety in the operation and
maintenance of this equipment. It is not intended to supersede,
replicate, or replace any safety documentation or procedures provided from or
established by ofcial safety sources.
Read and understand the Material Safety Data Sheets (MSDS) for the
materials used with this equipment. All personnel who work in the vicinity of this
equipment should read, understand, and follow all safety information
contained in the MSDSs and all government and facility safety regulations.
2.1 Basic Safety Recommendations
• Prevent formation of unsafe atmospheres- Ensure that properly engineered
 ventilationandatmosphericmonitoringsystemsareinstalledandoperatingproperly.
 Creatingaconned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.
• Ventilate working areas- Preventanyleakinggasesfromaccumulating.Ventallgasesto
 theoutsidetoanareathatissafelyawayfrompeople.Beforerestartingtheequipment,
 ensurethatallpartsaffectedbyrepairshavebeenrestoredtotheirproperoperating
 conditionandthatthelineshavenoleaks.
• Prevent injury-WearsafetyglassesandotherappropriatePPEwhentheMSDS,task,or
code dictates. Ensure that all tools and instruments used are in good condition. Be aware
 thathigh-velocitygasmaybereleasedatventsandsafetyreliefvalves
• Maintain safety devices- Checkallsafetydevicesatleastannuallyorasotherwise
 requiredbylocalcodesormanufacturerrecommendations.Properlymaintainsafetyvalves.
 Neverbypasssafetydevices,andneveroperatetheequipmentoutsideitsspeciedlimits.
WARNING: Read and understand this manual including any inserts/
amendments prior to using the NOxBOXi. Only trained and responsible
personnel should work with or around this equipment. Wear appropriate
personalprotectiveequipment(PPE),and,ifapplicable,turnoffthepower
beforeperforminganyinstallation,maintenance,repair,ortroubleshooting
procedures.
WARNING: Do not modify this equipment without authorisation of the
manufacturer.
2 Safety

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• Ensure safe maintenance and repair-Onlyqualiedpersonnelshouldrepairthe
 equipment.Protectpersonnelfromhazardsrelatedtounexpectedenergizing,start-up,or
 releaseofstoredenergyduringservicingormaintenancebyusingstrictequipmentlockout/
tagout procedures.
• Transportation- When transporting the NOxBOXi trolley ensure the correct procedure is
adhered to. Always use the handle at the front of the trolley. Ensure cylinders are securely
fastened and inspect for trip hazards such as sample lines.
DANGER: Failure to properly isolate equipment, electrical systems, and piping
can cause asphyxiation, re, and/or explosion. Positively isolate the equipment
from the gas supply and the process material before performing repair work. It is
not sufcient to simply close valves. Lines and tubing must be blanked or
disconnected.
DANGER: Additional hazards may be associated with the gases used in your
application and with your equipment. Determine which hazards you may
encounter, and be prepared to handle them. Refer to the MSDS supplied with the
gases and all government egulations and industry safety standards, e.g. COSHH
in UK.
DANGER: Exposure to gases or vapours may cause asphyxiation.
Proceed with caution and in accordance with the MSDS.
Practically all gases can act as simple asphyxiates by displacing the natural oxygen in
theair.Topreventseriouspersonnelinjuryandpossibledeath,provideadequate
ventilationtotheoutsideenvironmentinareaswhereanyprocessgasmay
accumulate. Consider the increased potential for asphyxiation when pressure testing or
purging equipment with nitrogen or other non-air gases.
DANGER: Electric shock can kill. Use extreme caution if troubleshooting or
servicing this equipment. Do NOT bypass safety interlocks. An electrocution
hazard exists even after the equipment has been de-energized. Only qualied
personnel working in compliance with all customer requirements and applicable
federal/national, state/ provincial, and local codes shall perform the electrical
wiring.
Basic Hazards
2.1.1 Asphyxiation
2.1.2 Electrocution

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• Tamperingwith,orunauthorizedsubstitutionof,componentsmayadversely
 affectthesafetyofthisequipment.Useonlyfactory-approvedcomponentsfor
repair.
• Turn off the power before opening the equipment or before checking or
replacing any component. Use tools designed for work on electrical equipment.
• CarefullyfollowallHazardousWorkPermit(HWP)andlockout/tagout
procedures for your facility.
• Donottouchliveelectricalcomponentsinsidetheequipment;electricshock
 causedbyvoltageinthecontrolcircuitscankill.
Pressure
DANGER: Mishandling of pressurized process equipment or gas cylinders can
resultindeath,seriousinjury,orpropertydamage.Handlepressurizedequipment
andcylinderswithextremecareandinaccordancewiththemanufacturer’s
instructions.
2.1.3 Toxicity
DANGER: Toxicgasescancausepersonnelinjuryordeaththroughbreathing,
absorptionthroughtheskin,orswallowing.Provideadequateventilation,
appropriatepersonalprotectiveequipment(PPE)andgasdetectionequipment.
Adheretothefollowingguidelinestohelpguardagainstpossibleelectrocution:
Thisequipmentcontainstoxicgases.Adequateventilationofenclosedareasservesasthechief
precautionagainstanaccumulationoftoxicgases.Inaddition,forhighlytoxicgases,install
automaticdevicestoconstantlymonitorgasconcentrationsandsetoffalarmsiftheconcentrations
approach a danger point. Bedfont offer suitable gas detection alarms as system accessories.
Precautions against skin or eye contact with toxic gases include a thorough knowledge of the
dangers,trainingforallpersonnelhandlingsuchgases,thedevelopmentofproceduresand
equipmentforhandlingthem,andtheuseofspecialprotectiveclothingandequipment(suchas
self-containedbreathingapparatus(SCBA),portablegasmonitors,protectivegarments,gloves,
andfaceshields).

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DANGER: Poisonous gases can be fatal if inhaled, even in very
small quantities. Provide adequate ventilation and appropriate
personal protective equipment (PPE).
2.1.4 Poisons
Thisequipmentcontainspoisonousgases.TheThresholdLimitValue(TLV)
expressedastheOccupationalExposureLimit(OEL)foreachgasrefers,in
general,toairborneconcentrationsatorbelowwhichnearlyallworkersmay
berepeatedlyexposedwithoutadverseeffects.TheTLVforthespecialty
gas used with this equipment are stated on the cylinder body labels and the
MSDS for the gas.
Usethisgasonlyinwell-ventilatedareas.Precautionsagainstskinoreye
contact with poisonous gases include a thorough knowledge of the
dangers,trainingforallpersonnelhandlingsuchgases,thedevelopmentof
proceduresandequipmentforhandlingthem,andtheuseofspecial
protectiveclothingandequipment(suchasself-containedbreathing
apparatus(SCBA),portablegasmonitors,protectivegarments,gloves,and
faceshields).
2.2 Hazard Labels
On locations of the NOxBOXisystemwherehazardsmayoccur,labelssuchastheoneshown
inFigure2.1.4-1:ExampleHazardLabel:NoPushing,warnyouofanypotentialdangers.Read
theselabelscarefully,andbepreparedtohandleanyhazardoussituationsthatmayarise.Ifthe
labelsbecomewornordifculttoread,contactyourBedfontrepresentativeforreplacement
labels.
Figure 2.1.4-1: Example Hazard Label: No Pushing
2.3 Cleaning Precautions
WARNING: Some cleaning agents or solvents can emit toxic fumes.
Conduct all cleaning operations in a well-ventilated area. Even though
many cleaning agents are not highly toxic, take appropriate precautions.
Allnewequipment,aswellasusedequipmentthatmayhavebecomecontaminatedduring
service,mustbethoroughlycleaned.Anyresiduecouldcontaminatetheprocessgasandmay
constitute a safety hazard.
Perform cleaning in accordance with applicable cleaning standards to ensure that the
equipment has been safely prepared for the application for which it is to be used. Carefully
inspectallcleanedparts.Ifanyevidenceofcontaminationisnoted,cleanthepartagain.
Bedfont offer suitable instrument cleaning wipes as system accessories.

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2.4 Electromagnetic Immunity
The NOxBOXicomplieswiththedirectiveEN60601-1-2electromagneticcompatibilitybut
can be affected by cellular phones and by electromagnetic interference exceeding the
levelsspeciedinEN55011:2007ClassB.
Guidance & Manufacturer’s Declaration: Electromagnetic Immunity (IEC 60601-1-2)
The NOxBOXi isintendedforuseintheelectromagneticenvironmentspeciedbelow.Thecustomerortheuserof
the NOxBOXi shouldassurethatitisusedinsuchanenvironment.
Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic
Environment
Guidance
Electrostatic Discharge
(ESD)
IEC 61000-4-2
±6kVcontact
±6kVair
±6kVcontact
±6kVair
Floorshouldbewood,concreteor
ceramictile.Ifoorsarecoveredwith
syntheticmaterialtherelativehumidity
should be at least 30%
Electrical fast transient/
burst
IEC 61000-4-4
±2kVforpowersupply
lines
±1kVforinput/output
lines
±2kVforpower
supply lines
Mains power quality should be that of
atypicalhospitalenvironment.
Surge
IEC 61000-4-5
±1kVlinetoline
±2kVlinetoearth
±1kVlinetoline
±2kVlinetoearth
Mains power quality should be that of
atypicalhospitalenvironment.
Voltagedips,short
interruptions and
voltagevariationson
power supply.
IEC 61000-4-11
< 5 % UT
(>95%dipinUT)
for 0.5 cycle
40 % UT
(60%dipinUT)
for 5 cycles
70 % UT
(30%dipinUT)
for 25 cycles
< 5 % UT
(95%dipinUT)
for 5 seconds
Met or exceeded. Mains power quality should be that of
atypicalhospitalenvironment.
Power frequency
(50/60Hz)
Magneticeld
IEC 61000-4-8
3 A/m 3 A/m
Power frequency
magneticeldsshouldbeatlevels
characteristic of a typical location in a
hospitalenvironment
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3Vms
150 kHz – 80 MHz
outside ISM bands*
10Vms
150 kHz – 80 MHz in
ISM bands*
10Vms
80 kHz – 2.5 GHz
10Vms
150 kHz – 80 MHz
outside ISM bands*
10Vms
150 kHz – 80 MHz in
ISM bands*
10Vms
80 kHz – 2.5 GHz
Portable and mobile RF
communications equipment should
be used no closer to any part of the
NOxBOXi,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the
followingsymbol:

11
NOTE 1: UT istheA.C.mainsvoltagepriortoapplicationofthetestlevel
NOTE 2: At80MHzand800MHz,thehigherfrequencyrangeapplies
NOTE 3: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorptionandreectionfromstructures,objectsandpeople.
TheISM(industrial,scientic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xed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xedRFtransmitters,anelectromagneticsitesurvey
shouldbeconsidered.IfthemeasuredeldstrengthinthelocationinwhichtheNOxBOXi is used exceeds the
applicableRFcompliancelevelabove,theNOxBOXishouldbeobservedtoverifynormaloperation.Ifabnormal
performanceisobserved,additionalmeasuresmaybenecessary,suchasreorientingorrelocatingtheNOxBOXi.
Overthefrequencyranges150kHzto80MHz,eldstrengthshouldbelessthan3V/m.
2.5 Network Connections
Thedeviceisnottobeconnectedtoanetwork.
ThesystemisprovidedwithaUSBport.Thisissolelyforthepurposeofdownloadingsystemlogs
forrecordandanalysisbyasuitablyqualiedSystemsEngineer.
2.6 Applied Parts
Thesystemhasnoappliedparts.HowevertheNOxFlowandSampleLinearetreatedasapplied
parts(apartfromlabellingrequirements)asperBSEN60601-1:2006Section4.6.
2.7 Isolation from Mains
WARNING: Operator should not contact the patient whilst simultaneously being in
contact with the NOxBOXi device.
Shutdownofthesystemiscoveredinsection6.13Shutdown.
In order to isolate the system from the mains unplug the Mains Power Supply. Do not position the
systemsothatthisisdifculttodo.

12
3 EQUIPMENT DESCRIPTION
The BEDFONT NOxBOXi IntelligentNitricOxideDeliveryandMonitoringSystemcontrolsdelivery
ofnitricoxide(NO)gasintotheventilatorinspiratorylimbofthepatientbreathingcircuittoprovide
aconsistentNOdoseconcentrationintheinspiredbreathtothepatient,assetbytheuser,forthe
purposesofInhaledNitricOxide(INO)therapy.
The NOxBOXisystemisdesignedtobecompatiblewithmostventilatormodels,usingthe
NOxFlowinlineowdetectionmoduletoenableprecisesynchronizedproportionalNOdelivery
into the inspiratory limb.
Toensurepatientsafety,theNOxBOXi systemprovidescontinuousmonitoringoftheinhalant
sample,analysingNO,oxygen(O2),andnitrogendioxide(NO2)levelsthroughouttreatment.Itis
also equipped with a full suite of alarms.
The NOxBOXisystemhasanmanualoverridefailsafecircuitforcontinuousapplicationofNO.The
NOxBOXisystemhasasimpledeliverycalculatorandasetoflook-uptablestoenablebestow
selection.
Fortransportandtransferconditions,theNOxBOXi has a rechargeable internal battery that
providesover4hours’usefromfullchargewhennomainspowersourceisavailable.
ThescopeofpatienttreatmentisdenedandcontrolledbytheNOdruglabelling.Primary
intendedclinicalsettingistheIntensiveCareUnit(ICU)withasecondaryintendedclinicalsetting
for the transport of ICU patients.
3.1 Intended Use
Always handle and store nitric oxide mixtures in accordance with
federal/national, state/provincial, and local codes and regulations.
WARNING:IntheeventofanalarmtriggeringontheNOxBOXi, rst take
measures to protect patientpriortotroubleshootingorrepairofthedevice.
WARNING: The NOxBOXi deviceisonlyintendedforapplicationofINO
therapy in combination with air and oxygen mixtures.
The NOxBOXi NitricOxideDeliverySystemisintendedforusebyhealthcareprofessionalsforthe
deliveryandmonitoringofNO,andthemonitoringofNO2and O2intheinspiratoryventilatorlines
ofapatientundergoinginhalednitricoxidetherapy(INO).
ThissystemwillperformasdescribedwithinthisTechincalGuide,userinterfaceinstructions,
systemlabelsand/orinserts,whenassembled,operated,maintainedandrepairedinaccordance
withtheinstructionsdenedwithinthisTechnicalGuide.
The NOxBOXimustonlybeusedisaccordancewiththeindications,contraindications,warnings
and precautions described in the Nitric Oxide drug packaging inserts and labelling. Refer to this
material prior to use.
1With no alarm conditions

13
The NOxBOXiisonlyintendedforusewith,andconnectionto,thespeciedaccessoriesand
single-patient use disposables as detailed within this technical guide.
3.2 Specication & Environment
NO 0-99.9 ppm
NO20-20.0 ppm
O20 – 99.9 %
NO Delivery Range (set point)
Measuring Range
0.6–80ppm(Notethesystemallowssettingat<=0.5
ppm,accuracyguresbelowarefor>=0.6ppm,useofa
lowersettingisatcustomerresponsibility)
NO input concentrations 200,225,250,300,400,450,500,800,900&1000ppm
NO Delivery and Measurement resolution 0.1 ppm
Means of disconnection Mains power supply plug
Mode of Operation: Synchronous(1.5-50Ltr/m)orContinuous
Sample Flow Rate: Approx. 225ml/min
Gas Concentration Detection Principle: Sealed electrochemical sensor
Accuracy: Monitoring:
NO&NO2:+/-2%or0.2ppm
whicheveristhegreaterplusthe
accuracy of the calibration gas
O2+/-3.5%
Automatic Mode Delivery
(measured
dose):
At the point of sampling at the
patient Y-piece the accuracy is that of
themonitoringsystemabove.
Delivery(with
respect to
set-point):
Thesystemwillservethedelivered
concentrationtotheset-pointsubjectto
theowfromtheventilator,seesection
“MaximumNODoseDelivery”belowfor
the set point range.
Once the measured dose and set point
agree then the accuracy w.r.t. the set
point is that of the monitoring system.
Until the set-point is reached then
the accuracy is that of the difference
between set-point and measured dose
plus the accuracy of the monitoring
system.
Manual Mode
Delivery(with
respect to
valueadvised
by the Dose
Calculator)
Dosecalculator,continuousow.
Thedelivereddosewillbe+/-30%of
thegureadvisedbytheonscreendose
calculator. Monitoring can be used to
determinetheactualvalue.
Intermittent(non-continuous)ventilation.
Accuracyhasonlybeenveriedwith
acontinuousowuse.Intermittent
owaccuracydosesvaluesmustbe
determined by the customer.
Display: Touch screen LCD
NOxBOXi
Standby Mode Set 0ppm

14
Alarms: Audibleandvisible
Set-up time: < 10 minutes
Response time:
< 10 seconds to 90% FSD NO
< 40 seconds to 90 % FSD NO2
< 15 seconds to 90 % FSD O2
Operating Temperature: 10 oC – 35 oC
Operating Humidity: 15 % - 85 % RH non-condensing
Storage Temperature: 0 oC – 40 oC
Storage Humidity: 15 – 90% non-condensing
Operating & Storage pressure: 800 – 1200 mBar
Sensor Operating Life: 2 years
Sensor Resolution: NO&NO2-0.1ppm
O2-1m Bar O2
Battery:
4 hours operation
Li-ion Polymer
745396/3900mAh/22.2V
Not User replaceable
Power Input: EXM 80 5121
100–240VAC,50/60Hz,1.7A
Dimensions: 330 mm x 250 mm x 108 mm
Weight: 6.2 kg
Construction: Rigidpolyurethane(PU)
WARNING:ForhighconcentrationsofNOexceeding80ppm,exposureshouldbelimitedtoamaximum
of 4 days in order to reduce the risk of sensor zero drift due to prolonged exposure. The NOxBOXiprotects
usersfromtheadverseeffectsofsensordriftbyperformingadailysensorzerocalibration.Ifasensorhas
drifted outside of acceptable limits the zero calibration will fail.

15
3.3.1 Abbreviations
NO
NO2
O2
ppm
Nitric Oxide
Nitrogen Dioxide
Oxygen
Parts per million
3.3.2 Denitions
NO Dose
Elapsed Treatment Time
Current Dose Treatment Time
Alarms
Settings
UsersettingofNOdosetodelivertopatient
TotalpatienttreatmenttimesincerstNOdosedelivery.
Time current dose setting has been administered to patient.
Alarmhistorytab:showsalarmlistfromcurrentsession.
Usersettingstab:accesstouser-adjustablesystemsettings
3.3.3 Icons Overview:
General Navigation
ServiceEngineerarea:presstoaccess.
Press Next to proceed to next screen.
PressBacktoreturntothepreviousscreen.
Skip step-by-step quick start guide instruction screens and skip to Dose.
Presstoacceptorconrmthestatementon-screen.
Press to decline or deny the statement on-screen.
Greyed out buttons indicate that they are temporarily disabled. An action or test
mustbeperformedorcompletedtoactivate.
Editvalue.
Main Monitor
 Alarmmute(activewhengasalarmistriggered).
Edit NO dose.
Upper alarm/limit setting.
Lower alarm/limit setting.
User Setting Screen
ManualOverridecalculator:Showsapproximatedosevaluefromeach  
 manualoverridesetting(50-600ml)forpatientventilatorowsetting.
 Zerocalibration:Sensorzerobaselinetest.Systempromptreminderonce 
 every24hoursduringuse.CaninitiatefromSettingsscreen.
3.3 Denitions, Abbreviations and Icons

16
3.3.4 Rear Label Symbols
Listsnameandcontactdetailsofdevicemanufacturer.
Yearofmanufacture:dateshownbelowthissymbolindicatestheyearthe
devicewasmade.
Deviceserialnumber.
Consult the Instructions for Use.
Caution:specicwarningsorprecautionsforuseofthisdevicearelistedin
accompanying documents.
EquipmentisgovernedbytheWEEEdirective.Contactyourdistributorforcorrect
disposalofthisdevice.
CEMarkeddevice.SymbolcertiesthattheproductmeetsEUconsumersafety,
healthandenvironmentalrequirementsforthisproducttype.
3.3.5 Front Label Symbols
Intelligentdelivery:thesystemisinfullyadaptivedeliverymodethatcontrolsthe
NOdosedeliverytothepatienttothemostefcientandsafedeliveryprole.
Manualoverridecontinuousow:foremergencybackupandmanualbaggingof
patients.TheNOowisoneoftheselectedowssetbytheuser.Thisowis
continuous and cannot adapt to changing conditions. Patient monitoring must be
observedbyoperatortoensurecorrectdoselevelsareachieved.
3.3.6 Power Supply Symbols
DangerousVoltage.
Indoor Use Only.
Class II Equipment.

17
3.3.7 Accessory Label Symbols
TypeBAppliedPart:non-conductive
Singlepatientusedevice
Latex Free product
Deviceshouldnotbeusedaftertheendoftheyear,monthordayshown
3.3.8 Manual Override Flow Selector Valve Markings
50 50 cc/min
100 100 cc/min
200 200 cc/min
300 300 cc/min
400 400 cc/min
500 500 cc/min
Noteallvaluesshownareapproximate
to+/-15%.Refertolook-uptablesfor
indicationofdoseperventilatorowrate.
Monitoring of patient dose must be
implementedwhenusingManualOverride
owdeliveryofNO.
3.4 System Components
Each NOxBOXisystem has a unique serial unit
identicationnumberoftheformat.
NI10001
Thisisfoundonthedevicelabel
(Figure0-1)attachedtotherearofthe
deviceandshouldbequotedwhencontacting
themanufacturerordistributorforservicingand
repairs.
The rear label on NOxBOXi,additionallyhasthe
manufacturer contact details and year of
manufactureforthedevice.
600 600 cc/min
Figure 0-1: NOxBOXiDevice Label
2014

18
3.4.1 NOxBOXi System Features
1. Touch Screen Display
2. ModeSelectionValve
3. ManualOverrideFlow
 ControlValve
4. NOxFlow Sensor
Connector
5. NOxFlow Dose
Connector
6. Patient Sample Inlet
7. Water Trap Bottle
1
2
3
8. Handle
9. Quick Release Button
10. Power Inlet Socket
11. Charging Indicator LED
12. Zero Inlet
13. USB Port
14. Power Button
15. NOxBOXigasinlets:4
bar max.
16. Gas Line Purge Needle
4
5
6
7
8
9
10
11
12
13
14
15
16

19
Figure 3.4.1-1: System Features
17. NOxBOXi Nitric
 OxideRegulator(x2)–
Connector type dependent
on supplier.
18. NOxBOXiSupplyLines(x2)
19. NOxBOXi Power Supply
 (x1)–4InternationalAC
plug adaptors included.

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3.5 NOxBOXiEffect on Ventilator Circuit
The NOxBOXihastwomainconnectionstothepatientventilatorcircuit.Theseproducethe
followingeffects:
 1. AttheNOxFlow:NO/N2 concentratedgasisdeliveredintotheinspiratorylimb 
  oftheventilatorcircuitindirectproportiontotheventilatorairow.Theproportionof
  gasaddedisadjusteddependingondesiredpatientdoseandtheconcentrationof
  theNOgassupply.Forexample,toachievea20ppmdosefroma400ppmcylinder
  supply,theNOxBOXiisadding5%moregastotheairvolumebeingdeliveredbythe
  ventilator.
 2. AttheSampleLine:TheNOxBOXisamplesaside-streamfromtheventilator 
  gasesatanominalrateof225ml/min(0.225L/min).
3.5.1 Oxygen Dilution
Adding the NO/N2gastothecircuithastheeffectofproportionallydilutingthedelivered
oxygen concentration. The NOxBOXimonitorstheoxygenlevelbeingdeliveredtothe
patient to assist the user in monitoring this effect. Oxygen dilution is directly related to the
proportion of NO gas that is added to the circuit.
Worked example:
 Fora20ppmdosefroma400ppmcylinder:5%NO/N2gasisaddedtotheventilatorair
 ow;theO2isthereforedilutedby5%ofitsoriginalvalue.
If the O2 wasoriginally50%v/v,theO2concentration after the NO is introduced will be
 approximately47.5%v/v
3.5.2 Measured Minute Volume
ThemeasuredvolumeventilationmaybemodiedslightlybytheneteffectoftheNOxBOXi
addingandremovinggasesfromtheventilatorcircuit.Thismayrequiresomemodications
toventilatorsettingstocompensate.
AddedminutevolumeofNOgascanbecalculatedusing:
NODosexMinuteVolume
Cylinder Concentration - NO Dose =Addedminutevolume
Worked Example:
Minutevolume=10L/min
Dose=10ppm
Cylinderconcentration=400ppm
Thentheaddedminutevolumemaybecalculated:
(10 x 10)/(400 – 10) = 0.26 L/min
Tocalculatethenetchange,subtracttheNOxBOXisamplingratefromtheaddedminute
volume:
0.26 – 0.225 = 0.035 L/min