NIOX MINO - Clinical Context and Vigilance; Clinical Documentation and References; Adverse Incident Reporting (Vigilance)

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homeenvironments,suchasbasestationsfor
radio,cellular/cordlesstelephonesandland
mobileradios,amateurradio,AMandFMradio
broadcastandTVbroadcast,itispossiblethat
highlevelsofsuchinterferencesduetoclose
proximityorstrengthofasource,mayresult
indisruptionofperformanceofthedevice.If
abnormalperformanceisobserved,itmaybe
necessarytoreorientorrelocateNIOXMINO.
•APCconnectedtotheUSBconnectorhastobe
certiedforoneofthestandardsIEC60601-1,
IEC61010-1,IEC60950orcomparablewith
safetyextralowvoltageontheUSBports.
•TheconnectedPCshouldbeplacedoutofreach
fromthepatient.Donot,simultaneously,touch
theconnectedPCandthepatient.
Clinical documentation
NIOXMINOfollowstheAmericanThoracic
Society(ATS)andEuropeanRespiratorySociety
(ERS)2005equipmentrecommendationsfor
measurementofexhaledNO.
1
Therecommendationsarebasedonanalysis
ofNOwiththechemiluminesencemethod.
However,NIOXMINOisusingadifferentmethod
(electrochemistry).Oneconsequenceofthisisthat
theNIOXMINOSensordoesnotneedanyeld
calibration*.Agreementhasbeendemonstratedfor
themeanoftwovalidexhaledNOmeasurements
inNIOXandtherstvalidNOmeasurementin
NIOXMINO.
2-5
Supportedbythesedata,onevalidNO
measurementshouldbeconsideredsufcient,
insteadoftwoasrecommendedintheguideline.
1
Am J Respir Crit Care Med 2005; 171: 912-930.
2
AlvingK,JanssonC,NordvallL:Performanceof
anewhand-helddeviceforexhalednitricoxide
measurementinadultsandchildren.Respiratory
Research2006;7:67-5.
3
McGillC,MalikG,TurnerS.Validationof
ahand-heldexhalednitricoxideanalyzer
foruseinchildren.PediatrPulmonol.2006
Nov;41(11):1053-7.
4
KhaliliB,BoggsPB,BahnaSL.Reliabilityofa
newhand-helddeviceforthemeasurementof
exhalednitricoxide.Allergy2007;62:1171-1174.
5
MenziesD,NairA,LipworthBJ.Portable
exhalednitricoxidemeasurement:Comparison
withthe"goldstandard"technique.Chest
2007;131(2):410-4.
*TheSensorisalreadycalibratedduring
manufacturinganddoesnotneedtobere-
calibrated.
Vigilance
Circassia,asamedicaldevicemanufacturer,
must have a system in place to report to health
authorities,anyadverseincidentsthathave
occurredwithitsmedicalproducts,aso-called
Vigilancesystem.
ThepurposeoftheVigilancesystemistoensure
thehealthandsafetyofpatients,usersand
othersusingmedicalproductsbyreducingthe
likelihood of the same type of adverse incident
beingrepeated.Thisisachievedbyimmediate
noticationofincidentstoenablecorrectiveand
preventiveactions.
Anadverseincidentisdenedas:Anymalfunction
ordeteriorationinthecharacteristicsand/or
performanceofadevice,oranyinadequacyinthe
labellingorinstructionsforusewhichmightlead
toormighthaveledtothedeathofapatientor
userortoaseriousdeteriorationinhis/herstateof
health.
Manufacturersofmedicaldevicesareobliged
to report adverse incidents to national health
authoritieswithin10or30days,dependentonthe
severityoftheincident.
AnyuserofCircassia'sproducts,whoexperience
anadverseincidentrelatedtotheproduct,must
thereforeimmediatelyreportthistoCircassiaor
Circassia'slocalmarketrepresentative.Thereport
canbemadebye-mail,fax,ortelephone.
Thereportshouldcontainthefollowinginformation:
•Whenandwheredidtheincidentoccur?
•Whatproduct/accessorywasinvolved?
• Was the incident related to instructions for use of
theproduct?
• Was the risk foreseeable and clinically acceptable
inviewofpotentialpatientbenet?
• Was the outcome adversely affected by a
patient'spre-existingcondition?
ThereportshouldbeforwardedtoCircassia'slocal
representativeinthecountrywheretheincident
occurred.