Bedfont NoxBox - Equipment Description; Intended Use

12
3 EQUIPMENT DESCRIPTION
The BEDFONT NOxBOX
i
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 NOxBOX
i
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NOxBOX
i
systemprovidescontinuousmonitoringoftheinhalant
sample,analysingNO,oxygen(O
2
),andnitrogendioxide(NO
2
)levelsthroughouttreatment.Itis
also equipped with a full suite of alarms.
The NOxBOX
i
systemhasanmanualoverridefailsafecircuitforcontinuousapplicationofNO.The
NOxBOX
i
systemhasasimpledeliverycalculatorandasetoflook-uptablestoenablebestow
selection.
Fortransportandtransferconditions,theNOxBOX
i
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NOxBOX
i,
rst take
measures to protect patientpriortotroubleshootingorrepairofthedevice.
WARNING: The NOxBOX
i
deviceisonlyintendedforapplicationofINO
therapy in combination with air and oxygen mixtures.
The NOxBOX
i
NitricOxideDeliverySystemisintendedforusebyhealthcareprofessionalsforthe
deliveryandmonitoringofNO,andthemonitoringofNO
2
and O
2
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 NOxBOX
i
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.
1
With no alarm conditions