Mallinckrodt INOblender 10026 User manual

Part No. 20003 Rev - 01 Part No. 20732 Rev-02
2014-02
Operation and Maintenance Manual
(English)

User Responsibility
This Product will perform in conformity with the
description contained in this operating manual
and accompanying labels and/or inserts, when
assembled, operated, maintained and repaired
in accordance with the instructions provided. This
Product must be checked prior to use following the
Pre-Use Checkout procedure described in section
3. A defective Product should not be used. Parts
that are broken, missing, visibly worn, distorted or
contaminated should be replaced immediately.
Should such repair or replacement become
necessary, the manufacturer recommends that a
telephone request for service advice be made to
the local distributor. This Product or any of its parts
should not be repaired other than in accordance with
written instructions provided by the manufacturer or
local distributor. The Product must not be altered.
The user of this Product shall have the sole
responsibility for any malfunction which results
from improper use, faulty maintenance, improper
repair, damage, or alteration by anyone other than
Mallinckrodt Representatives.
Outside the U.S.A. and Canada, check local
laws for any restrictions that may apply.
Caution: U.S. Federal and Canadian law restrict
this device to sale by or on the order of a licensed
medical practitioner.
Inhaled Nitric Oxide mixtures must be handled
and stored in compliance with federal, state and
local regulations.
These products have unit serial numbers with coded
logic which indicate the year of manufacture and a
sequential unit number for identication.
Mallinckrodt, the “M” brand mark and the Mallinckrodt Pharmaceuticals logo are trademark of a Mallinckrodt company. Other brands are trademarks
of a Mallinckrodt company or their respective owner. ©2016 Mallinckrodt
BL 20051234
The rst two digits indicate the product, the next four numeric digits
indicate the year of manufacture, and the next four digits are the
sequential unit number produced that year.
10026 INOblender (DISS, 800 ppm, English)
10004 INOblender (DISS, 800 ppm, English)
10021 INOblender (NIST, 400 ppm, English)
10070 INOblender (NIST, 800 ppm, English)
Part No. 20732 Rev-02
2014-02

Part No. 20732 Rev-02
2014-02
1
1. General Information.............................................................................................................3
Introduction.......................................................................................................................4
  DenitionsandAbbreviations ...........................................................................................4
Theory of Operation..........................................................................................................5
  EnvironmentalEffects.......................................................................................................6
2. Setup ...................................................................................................................................7
3. Pre-UseCheckout ...............................................................................................................9
4. Operation...........................................................................................................................12
5. Maintenance ......................................................................................................................15
  ReplacingRegulatorTips................................................................................................16
  CylinderLeakCheck.......................................................................................................18
  PartsandAccessories ....................................................................................................19
6. Specications.....................................................................................................................21
Contents

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Part No. 20003 Rev - 01 Part No. 20732 Rev-02
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1/ General Information
General
Information

Part No. 20732 Rev-02
2014-02
1/ General Information
General
Information

Part No. 20732 Rev-02
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3
CautionsandWarnings
WARNINGS:
• The purge procedure must be followed
to help ensure NO2is purged from the
pressure regulator, INOblender and hoses
before the manual resuscitator bag or nasal
cannula is connected to the patient. The
manual bag should be squeezed repeatedly
during use to avoid NO2building up in the
bag. If the bag is not squeezed repeatedly
while delivering INOMAX the bag should
be removed from the patient and the purge
procedure performed before continuing.
• The INOblender should only be used
in accordance with the indications,
usage, contraindications, warnings and
precautions described in the INOMAX drug
package insert and labeling. Refer to this
material prior to use.
• Persons using this device should be trained
on and experienced in the use of this
device to assure effective administration of
INOMAX and to avoid injury to the patient
or others resulting from inhalation of
excess INOMAX, nitrogen dioxide or other
reaction products.
• The National Institute for Occupational
Safety and Health (NIOSH) in the U.S. has
a recommended time-weighted (8 hours)
average concentration of 25 ppm for NO
and a limit of 1 ppm for NO2. Persons using
the INOblender who may be particularly
sensitive to NO or NO2, or who may be
exposed to these agents for prolonged
periods as a result of the use of this device,
should be aware that the INOblender
does not scavenge the exhaust drug,
and that this is vented at the resuscitator
bag. Ambient concentrations of NO or
NO2are expected to be less than 0.2 ppm
when using the INOblender, see Section 1
Environmental Effects.
Cautions:
• OutsidetheU.S.andCanada,checklocal
lawsforanyrestrictionsthatmayapply.
U.S.federallawandCanadianlawrestrictthis
devicetosalebyorontheorderofalicensed
medical practitioner.
• Properuseofthisproductdependsoncareful
readingandunderstandingoflabelingand
instructions.
• Tohelpensureproperoperationofthis
product,completethepre-usecheckoutprior
toeachuse.
• Whennotinuse,theO2owmeterandthe
INOMAXcylindervalveshouldbeturnedoff.
• Whencleaning,donotsubmergeinliquid.
• Donotautoclave.
• Refertothemanufacturer’sproceduresfor
usingtheresuscitationbag.
WARNING:
Warnings tell you about dangerous conditions
that can cause injury to the operator or the
patient if you do not obey all of the instructions
in this manual.
Caution:
Cautionstellyouabouthowtoproperlyuse
theequipmentandconditionsthatcouldcause
damagetotheequipment.
Readandobeyallwarningsandcautions.
Note:
Notesprovideclaricationorsupplementalinformation.
Bluearrowdenotesrequireduseraction.

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4
Pneumatic Outlet
Rx ONLY Prescriptionuseonly
Pressure
Productpackagingisabletobe
recycled
Protectfromheatandradioactivesources
SN SerialNumber
StorageTemperatureLimitation
StorageHumidityLimitation
Thisproductisincompliancewiththe
EuropeanCouncilDirective93/42/EEC
anditsamendmentsconcerningmedical
devices
Attention,consultaccompanying
documents!
AuthorizedRepresentativeinthe
EuropeanCommunity
CatalogNumber
Date of Manufacture
Fragile,handlewithcare
Keep Dry
Manufacturer
NO or O2GasInlet
NOGasOutlet
Pneumatic Inlet
Introduction
TheINOblenderallowsuserstoselectaconcentrationofINOMAX,(nitricoxideinabalanceofnitrogen),to
bemixedintoausersetowofoxygenwhichisdeliveredtoapatient.TheintendedusefortheINOblender
isasabackuptoaprimaryINOMAXdeliverysystem;orforshorttermattendedusewhenaprimarydelivery
devicecannotpracticablybeused.Thisintendeduseincludesapplicationswithinamedicalfacilityand
transportoutsideofamedicalfacility.TheINOblenderisnotintendedforuseasaprimaryINOMAXdelivery
systemforlongtermuse.
Denitions and abbreviations
N2Nitrogen
NO INOMAX(nitricoxide)forinhalation
NO2Nitrogendioxide
NO/N2Nitricoxide(NO)andnitrogen(N2)gasmixture
O2Oxygen
ppm PartsPerMillion
Set NO ThedoseofINOMAXsetbytheuser
v/v Volumetovolume
Note:ThismanualshowstheSetNOdisplaysassociatedwiththe0-80ppmrange.
Symbols used in this manual or on the system
Symbolsreplacewordsontheequipmentand/orinthismanual.Thesesymbolsinclude:

Part No. 20732 Rev-02
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5
INOblender Schematic Diagram
Theory of Operation
1. TheINOblenderconnectstoa3-5bar(45-75psig)oxygensupply.Theoxygenowisthen
controlledbyanintegratedoxygenowmeter(2-14lpm).Thereisaxedrestrictorintheoxygen
owpathwhichcreatesapressureproportionaltotheoxygenowrate.
2. TheINOblenderisalsoconnectedtoa2bar(30psig)INOMAX(800ppmor400ppm)supply.
• The INOMAXowiscontrolledbyabalanceregulatorinproportiontotheoxygenpressure
causedbythexedrestrictorandtheINOblendersetting.
 • ThebalanceregulatormaintainsaconstantINOMAXdoseforvaryingoxygenowrates.
3. TheowsofO2and INOMAXaremixedpriortoexitingtheINOblenderoutlet.
INOMAX
Cylinder
INOMAX
Regulator
Oxygen
Source
Balance
Regulator
Dose Knob
INOMAX and
O2Outlet
Fixed Laminar
Restrictor
INOMAX
Oxygen
Oxygen/INOMAX

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6
EnvironmentalEffects
TheNationalInstituteforOccupationalSafetyand
Health(NIOSH)hasrecommendedexposurelimits
asfollows(ref1).
 NO time-weighted(8hours)average 
concentration limit of 25 ppm
NO2ceiling limit of 1 ppm.
Theenvironmentalbuildupofnitricoxide in a well
ventilatedICUroomcanbeevaluatedusingthe
followingcalculation:
Roomsize 10ftsquare(approx.3meters)
 Roomvolume 27,000L
of air
 Roomventilation 2,700L/min
at 6 room
 changes/hr
 NOowintoroom 14L/minat80ppm
 Averageroom 80x14/2,700=0.4ppmofNO
concentration
of NO
Thistheoreticcalculationcanbesupplementedby
measurementsasperformedbyHessetal.The
NO and NO2concentrationsweremeasuredusing
achemiluminescenceanalyzerwhen100ppmof
NOat8L/minwasdeliveredintoaroomwithno
scavengingbeingused.ThemaximumNO and NO2
concentrationsmeasuredoveraone-hourperiod
were0.12ppmofNOand0.03ppmofNO2.
Bothmethodsshowthattheexposurelevelsare
signicantlylessthanthelevelsrecommended
byNIOSH.
IfthelocationforusingNOhasuncertainventilation,
thenthelocationshouldbeevaluatedforNO and
NO2builduppriortouse.
Ref. 1 Centers for Disease Control, Atlanta, GA
30333 USA. NIOSH Recommendations for
Occupational Safety and Health Standards
1988. August 26, 1988 / vol. 37 /No. 9.
Ref. 2 Hess et al, Use of Inhaled Nitric Oxide
in patients with Acute Respiratory Distress
Syndrome, Respiratory Care, 1996,
vol. 41, No 5, pg. 424-446.

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2/ Setup
Setup

Part No. 20732 Rev-02
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2/ Setup
Setup

Part No. 20732 Rev-02
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7
Setup
ChecktheINOMAXgascylinderforthecorrect
productidentitylabels,cylinderconcentration
(800or400ppm)andexpirationdate.Ensurethe
INOMAXgascylinderhas>14bar(200psig).
1.Connectahigh-pressureregulatortoan 
 INOMAXcylinderandhandtightenthetting
 totheINOMAXcylinder.
2.ConnecttheINOMAXregulatorhosetothe
 INOblenderinlethoseusingthequick
 connectttings.
3.ConnecttheoxygensupplytotheO2inlet
 tting.(seepartlistforcorrectoxygenhose)
 Note:3.5bar(50psig)nominal
1.MakesuretheNOdosesettingdialis 
 turnedtozero.
2.Attachamanualresuscitationbagtothe 
 INOblenderoutlettting.
Tooxygensource
TheINOblenderisnowsetup.ProceedtoSection3/Pre-useCheckout.
1
2
3
1
2
Note: •FortheCGA-typeINOMAXregulator
connector,ensurethewhiteplastictip
isnotchippedorcracked.Removeand
replaceasnecessary.(seeReplacingthe
tipontheINOMAXregulator,Page16).
 •FortheISO-typeregulatorconnector,
checkthattheO-ringispresentandis
notdamaged(seeReplacingthetipon
theINOMAXregulator,Page17).

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Part No. 20003 Rev - 01 Part No. 20732 Rev-02
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3/ Pre-Use Checkout
Pre-Use
Checkout

Part No. 20732 Rev-02
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3/ Pre-Use Checkout
Pre-Use
Checkout

Part No. 20732 Rev-02
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9
Pre-useCheckout
High-Pressure Leak Test
1.MakesureNOdosesettingdialisturnedtozero
andowmeterisOFF.
2.Openandthenclosethecylindervalve.
3.Pressuregaugeshouldindicate>14bar
(200psig).
4.Monitorpressuregaugefor30secondsfor
anysignsofpressuredecrease.Ifnopressure
decreaseisobserved,high-pressureleaktest
successful,proceedtoDeliveryConrmation
and Purge.
5.Ifobservedpressuredecreasecontinues,see
Section5/Maintenance;CylinderLeakCheck.
6.Ifleakcannotbetraced,replacetheINOblender.
Delivery Conrmation and Purge
1.SettheINOblenderto40ppmwhenusingan
 800ppmcylinder(20ppmwhenusinga400
 ppmcylinder).
2.SettheoxygenowontheINOblenderow
 meterto10L/mintobeginpurge.
3.Ensurethepressuregaugedecreases 
 approximately14bar(200psig)in10seconds
(+2sec.).
4.Continuepurginguntilpressuregauge
 readszero.
Caution: Tohelpensureproperoperation,completethepre-usecheckoutpriortoeachuse.
Set-uptheINOblenderasdescribedinSection2/Setup
TheINOblenderisnowreadyforuse.ProceedtoSection4/Operation.
2
3
1
2
4
Note: Ifthepressuredoesnotdecrease,then
theINOblenderisnotdeliveringNOand
theINOblendershouldbereplaced.
3

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Part No. 20003 Rev - 01 Part No. 20732 Rev-02
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4/ Operation
Operation

Part No. 20732 Rev-02
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4/ Operation
Operation