GaleMed MR-100 Plus User manual

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REF SAPREF Description
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2038 AR0051 MR‐100PlusIntakeValveKit

Introduction
TheMR‐100™Plus  ManualResuscitatorIsdesignedforuseasanadjunct
toartificialrespirationandcardiopulmonaryresuscitation.TheResuscitator
canbeusedtoventilatetheapnoeicpatientandtoaugmentventilation
and/oroxygendeliverytothespontaneouslybreathingpatient. 

Whenconnectedtoanoxygensource,theMR‐100TMPlus  Manual
Resuscitatorcanalsodeliversupplementaloxygenwiththeaidofanoxygen
reservoirTheoxygenconcentrationdeliveredbytheMR‐100TMPlus 
ManualResuscitatordependsontheoxygensupplyflowrate,tidalvolume,
ventilationfrequencyandoperatortechnique. 
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TheInfantandChildmodelsoftheMR‐100™Plus  ManualResuscitatorare
fittedwithpressurereliefvalveswhichventthedeliveredbreathtothe
atmosphereifthepressureexceeds40±5cmH20.Thepressurereliefvalve
canbeoverriddenbytheoperatorshouldahigherdeliverypressurebe
required. 
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TheMR‐100™Plus  ManualResuscitatorisintendedforusebyqualified
medicalandemergencypersonneltrainedinpulmonaryventilationand
advancedcardiaclifesupporttechniques.Usersshouldreadandunderstand
thecontentsofthismanualanddemonstrateproficiencyintheassembly,
disassemblyanduseofthisdevicepriortouse.
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WarningAndCautions
 WARNING:DonotusetheMR‐100"'Plus  ManualResuscitatorIntoxic
atmospheres.
 WARNING:RemovetheoxygenreservoirandreservoirvalveIf
supplementaloxygenIsnotbeingadministered.Failuretodosowill
affecttherefillrateandmaximumfrequencycapabilities.
 WARNING:Donotadministersupplementaloxygeninthepresenceof
openflames.
 WARNING:Donotuseoil,greaseorotherhydrocarbonbased
substancesonanypartoftheMR‐100TMPlus  ManualResuscitator.
Supplementaloxygen,
 suppliedunderpressure,cancombinewithhydrocarbonsandcause
explosions.
 WARNING:Thisdeviceisintendedforusebyqualifiedmedicaland
emergencypersonneltrainedinpulmonaryventilationandadvanced
cardiaclifesupporttechniques.
 WARNING:Alwaystestthedeviceinaccordancewiththismanualafter
cleaninganddisinfectionorreplacementofparts.
 WARNING:Donotusethepressurereliefvalveoverridmechanismfor
thechildandinfantresuscitator.
 CAUTION:UseonlyreplacementpartsintendedforuseonMR‐
100™Plus  ManualResuscitators.
 CAUTION:Donotattempttodisassemblethepressurereliefvalve
assembly.Disassemblywilldamagethecomponent.
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PrinciplesOfOperation1
TheMR‐100™Plus  ManualResuscitatorconsistsoffourmajorcomponents
(figure1):nonrebreathingvalveassembly(A),siliconebag(B),intakevalve
(C),andreservoir(D),PartDshouldberemovedifsupplementaloxygenis
nottobesuppliedfromanexternalgassource.
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Figure1.TheMR100TMPlus  ManualResuscitator
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Gasisdeliveredtothepatientbysqueezingthebag(seefigure2).  Positive
pressurewithinthebagcausedbyitscompressionclosestheintakevalve(E)
locatedatthebaseofthebag.Thiscausestheduckbillvalve(F)tocloseoff
theexpirationports(G)ofthenon‐rebreathingassembly.Further
compressionofthebagforcesgasthroughduckbillvalvetothepatient.If
supplementalgasisused,oxygenisdeliveredtothereservoir(D)during
compressionofthesiliconebag.
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Figure2.Exhalation
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PrinciplesOfOperation2
Exhalationbeginswhenthepatientexertspositivepressure(duringpassive
exhalation)onthepatientsideoftheduckbillvalve(F)orwhentheoperator
releasespressurefromthesiliconebag(8).Thevalveliftsdirectingthe
patient'sexpiratorygasesthroughtheexpirationports(G)ofthenon‐
rebreathingvalve(seefigure3).
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Figure3.lnspiration
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Thesiliconebagrefillsforthenextbreathduringpatientexhalation. 
Negativepressurewithinthebag(causedbytheexpansionofthe
compressedbag)openstheintakevalve(E),allowinggastoenterthebag
eitherfromtheatmosphereorfromthereservoir(D).
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ThereservoirshouldbeusedwheneversupplementaloxygenIsdelivered. 
(Supplementaloxygenmaybeadministeredwithoutusingthereservoirbut
maximumavailableoxygenconcentrationwillbereduced.)  Excessoxygen
ventstotheatmospherethroughthesafetyvalve
(H)shouldthereservoirfillbeforethenextdeliveredbreath.Ifthevolumeof
gasinthereservoirisinadequatetofillthesiliconebag,roomairmaybe
drawninthroughthereservoirvalvesafetyinlet(I).Theconcentrationofthe
oxygen‐enrichedgasenteringfromthereservoirwilldependonfactorssuch
asoxygennowrate,tidalvolume,ventilationrateandoperatortechnique.
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PrinciplesOfOperation3
TheInfantandChildmodelsoftheMR‐100™Plus  ManualResuscitatorare
fittedwithpressurereliefvalves(seefigure4).Thesevalvesopenwhenthe
pressureisinexcessof40±5cmH20.
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Figure4.PressureRelieveValve.
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Shouldhigherinspiratorypressureberequired,thepressurereliefvalve
maybeoverriddenbyplacingthumboverthevalveasshowninfigure5.It
IsalsopossibletolockthepressurereliefvalveinthispositionwithLock
typeNonrebreathingValve.Justtwistthevalvehalfaturnanditwillstay
intheoverriddenposition.(LockArrowforwardtotheNRVdirectionas
Figure5.1).
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Figure5.1
Figure5.OverridingthePressureRelieveValve
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OperatingInstruction
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Note:lfthepatientisintubatedorhasatracheostomy,theresuscitatorcanbe
connectedbyremovingthemaskandattachingthenon-rebreathingvalveoutlet 
directlytotheconnectoroftheendotrachealortracheostomytube.
1. Positionvictimfaceup.
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2. Clearforeignobjects
outofpatient'smouth
andthroat.
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3. Insertoropharyngeal
airway(ifavailable),in
accordancewiththe
manufacturer's
directions,toopenthe
patient'smouthand
preventthetongue
fromobstructingthe
airway.
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4. Positionyourselfbehind
thepatient'shead,
extendtheheadback
andpullthechin

OperatingInstruction
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GeneralInstructionsforOperation
SelecttheappropriatesizeofMR‐100™Plus  ManualResuscitator(Infant,
ChildorAdult).SelecttheappropriatesizeoffacemaskIfventilationby
maskistobeperformed.Connectmasktotheoutletonnon‐rebreathing
valve. 
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Ifsupplementaloxygenistobeused,connectsupplytubing(notsupplied)
betweentheregulatedgassourceandtheoxygenreservoirinlet.Adjustgas
flowsothatthereservoirexpandscompletelyduringthedeliveryofthe
breathandnearlycollapsesasthebagrefills.
Ifsupplementaloxygenisnottobeused,removethereservoir.Failuretodo
sowillaffecttherefillrateandmaximumfrequencycapabilities. 
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Shouldthenon‐rebreathingvalvebecomecontaminatedwithvomit,blood
orsecretionsduringventilation,disconnecttheResuscitatorfromthe
patientandclearthenon‐rebreathingvalveasfollows:
Squeezethesiliconebagtodeliverseveralsharpbreathsthroughthenon‐
rebreathingvalvetoexpelthecontamination.Ifthecontaminationdoesnot
clear,continueventilationwithanotherresuscitatororusemouthto
mouth/masktechniques.  Disassemblethenon‐rebreathingvalveandrinse
itwithwater.Reassembleanddisinfect.
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Oncetheprocedureiscompleted,clean,disinfectandtesttheResuscitator
asdescribedunderCleaning&Disinfection(P.14)&TestingtheResuscitator
(P.15).
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5. Holdmaskfirmlyinplaceover
themouthandnosewith
thumbandindexfinger,using
otherfingerstogripthechin.
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6. Inflatethelungby
compressingresuscitationbag
withtheotherhand.Develop
rhythmicpatternfor
adequateinspiratory/
expiratorytime.
7. Checktoensurethatyouare
performingventilation
properly
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 Observeriseandfallofthe
patient'schest.
 Checkthepatient'slipand
facecolorthroughthe
transparentfacemask.
 Checkthatthepatientvalve
isworkingproperlythrough
thetransparenthousing.
 Checkthattheinteriorof
themaskisbeing"fogged"

PerformanceCharacteristics
Rangeofdeliverypressure
Adult:Unrestrictedor60±10cmH2O
ChildandInfant:40±5cmH20maximum(canbeoverriddenbyoperator)

Strokevolumerange(typicalvalues)
Adult Usingonehand 800ml
 Usingtwohands 1350ml
Child  350ml
Infant  160ml
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Oxygenconcentration
Adult(ValuesInparenthesesarewithoutanoxygenreservoir0
2
flowInTidalvol.(ml)xventilationrate)
L/min 600X12 800X20 750X12 750X20 1000X20 1000X20
05 82(33) 56(33)65(33)50(30)55(30)45(30)
10 99(37) 60(37)99(37)99(37)66(37)62(37)
15 99(45) 99(45)99(45)99(45)99(45)66(45)
Conditions:compliance‐0.02L/cmH
2
O,Resistence‐20cmH
2
O/L/s.l:Eratio:1:2

Child(ValuesInparenthesesarewithoutanoxygenreservoir0
2
flowInTidalvol.(ml)xventilationrate)
L/min70x20 70X30 200X20 200X30 300X20 300X30
02 99(65) 95(65)56(37)50(37)45(34)40(32)
05 99(86)99(83)99(44)96(43)84(37)88(36)
10 99(93)99(90)99(46)99(45)99(45)99(43)
Conditions:compliance‐0.01L/cmH
2
O,Resistance‐200cmH
2
O/L/s.l:Eratio:1:2

Infant(ValuesInparenthesesarewithoutanoxygenreservoir0
2
flowInTidalvol.(ml)xventilationrate)
L/min 20X30 20X60 40X30 40X60 70X30 70X60
02 99(72)99(70)99(70)99(58)97(55)85(50)
05 99(77)99(75)99(74)99(72)99(65)85(62)
10 99(94)99(90)99(90)99(80)99(79)99(71)
Conditions:
VT=20ml,Compliance‐0.001L/cmH
2
O,Resistance‐400cmH
2
O/L/s.l:Eratio:1:1
VT=40&70ml,Compliance‐0.01L/cmH
2
O,Resistance‐20cmH
2
O/L/s.l:Eratio:1:2
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AssemblyView
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Note: Should you need to order replacement parts for MRꞏ100™ Plus,
p
lease use the re
-
o
rde
r
numbe
r
alon
g
with the drawin
g.

PerformanceCharacteristics
TheperformancecharacteristicsforMR‐100™Plus  ManualResuscitators
willvaryfromusertouserdependingonavarietyoffactors:ambient
temperature,patientlungcompliance,ventilatorfrequency&   sizeof
operator'shands.ThefollowingdatahasbeenderivedfromMR‐100™Plus 
ManualResuscitatorsinaccordancewithISOstandards.
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Frequencyrange

-18oC/0oF
Cyclerate
22oC/72oF
Cyclerate
50oC/122oF
Cyclerate
Adult 38 45 45
ChildA 92 105 105
ChildB 72 78 76
InfantA 95 95 95
InfantB 60 60 60
Theseresultswereobtainedunderthefollowingconditions:
Adult:VT-600ml,Compliance-002L/cmH2O,Resistance-20cmH2O/L/s 
ChildA:VT-70ml,Compliance-001L/cmH2O,Resistance-20cmH2O/L/s 
ChildB:VT-300ml,Compliance-0.02L/cmH2O,Resistance-20cmH2O/L/s
InfantA:VT-20ml,Compliance-0.001L/cmH2O,Resistance-400cmH2O/L/s 
InfantB:VT-70ml,Compliance-001L/cmH2O,Resistance-20cmH2O/L/s
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Specifications
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Storage temp: - 40'C/-10'F to 60'C/ 140'F
Operating temp: - 1 8'C/ O'F to 50'C/ 122'F
Materials:
Silicon rubber:
Mask, Duckbill valve, Mushroom
valve, Relief valve seal, Bag body,
Oxygen reservoir bag, Oxygen
reservoir bag band & plug.
Polysulfone: Non-rebreathing valve housing,
Pressure relief valve housing, A l l - in
one intake valve housing, Pressure
relief valve stem & cap.
Poly-vinyl-chloride: Oxygen tubing
Stainless steel: Pressure relief valve
spring. Aluminum: Pressure relief name plate.
EPDM: O-ring
Connections:
Patient port
Silicon bag neck
Oxygen gas inlet
Intake valve port
Reservoir bag port 25mmlD
15mmlD/22mmOD
24mmlD
6mmOD
25mmOD

Specifications
Deadapace:
Non‐rebreathingvalve 
Adultmask
Childmask
Infantmask
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PressureRelief
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Reservoirvolume 
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Bagvolume/Strokevolume
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MaximumBPM
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OxygenConcentration
Withreservoir
Withoutreservoir
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TestingTheResuscitator
TheMR‐100™Plus  ManualResuscitatorshouldbetestedasfollows:
 whenfirstusingthenewResuscitator
 aftercleaninganddisinfection
 afteranynewpartshavingbeenfitted
 monthly,iftheResuscitatorisnotfrequentlyused.
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Equipmentrequired:Testlung,0‐100cmH20manometer(forInfantand  
Childresuscitatorsonly),flowmeter,regulatedgassupply&gassupply
tubing.
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Testingthesiliconebagassembly
1. Removethenon‐rebreathingvalveandtheoxygenreservoir(iffitted).
2. Compressthesiliconebagandocclude(block)thenon‐rebreathingvalve
outlet.
3. Releasethebag.Thebagshouldexpandimmediatelyandrefill.Ifnot,
checktheintakevalveatthebaseofthesiliconebagiscorrectly
assembledornot.
4. Whilekeepingthenon‐rebreathingvalveoutletblocked,compressthe  
bagagain.ThebagshouldnotbecompressedeasilyIfthisoccurs,check
thatyouareblockingthevalvesufficiently,andthattheintakevalveat
thebaseofthesiliconebagiscorrectlyassembled.
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Non‐rebreathingvalveassembly
1. Connectthenon‐rebreathingvalvetothesiliconebag.Connectthetest  
lungtotheoutletonthenon‐rebreathingvalveandiscorrectly
assembled.
7ml
150ml
95ml
28ml
40±5 cmH20 (infant & child)
60±1 0 cm a H20 (adult)
2000ml (adult model)
1000ml (child model)
500ml (Infant model)
1500/1350ml (adult model)
600/ 350ml (child model)
280/ 160ml (infant model)
45 breaths/min (adult model)
105 breaths/min (child model)
98 breaths/min (Infant model)
99%
45% (adult and child model)
90% (infant model)

2. Compressandholdthebag.Thehousingduckbillvalveinsidethenon‐
rebreathingvalveshouldopenandtestlungshouldbefilled.Ifnot,
checktheconnectionbetweentheResuscitatorandthetestlung,and
checkthatthenon‐rebreathingvalveiscorrectlyassembled.
3. Releasethebag.Theduckbillvalveshouldcloseandasthetestlung  
deflates,gasshouldflowthroughtheexpiratoryportsofthenon‐
rebreathingvalve.Ifnot,checkifthenon‐rebreathingvalveiscorrectly
assembled.
4. Ventilatethetestlungforaminimumoftencyclestoensurethatthe
Resuscitatorisfunctioningcorrectly.Inspirationmustoccurwhen
thesiliconebagiscompressedandexhalationshouldbeinplace,when
thebagisreleased.Ifnot,checkonthenon‐rebreathingvalveis
correctlyassembled.
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Tocheckthefunctionofthepressurereliefvalve(infantandChild
Resuscitators)
Connecta0‐100cmH20manometertothepatientoutletofthenon‐
rebreathingvalve.Compressthebag.Whenthepressurereliefvalve
activates,themanometershouldread35‐45cmH20.Ifnot,checkthatthe
non‐rebreathingvalveiscorrectlyassembledanddoesnotleak.Ifthe
pressurereliefvalvefailsafurthertest,itmustbereplaced.Donotattempt
torepairthepressurereliefvalve.
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OxygenReservoir/IntakeValveassemblies
1. Attachthereservoirtotheintakevalveinlet.
2. Inflatethereservoirandblockthereservoirport.
3. Compressthereservoirbag.Gasshouldescapethroughthesafetyoutlet
valveonthereservoirvalve.Ifnot,checkifthereservoirvalveis
correctlyassembled.
4. CycletheResuscitatorthroughseveralventilations.Thesafetyinletvalve
onthereservoirvalveshouldopenduringeachrefilltoallowroomairto
enterthesiliconebag.Ifnot,checkifthesafetyinletvalveiscorrectly
assembled.
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OverallResuscitatorfunction
1. FullyassembletheResuscitator(non‐rebreathingvalve,siliconebagand
oxygenreservoir).ConnecttheResuscitatortoasupplementalgassource
andconnectatestlungtothepatientoutletonthenon‐rebreathing
valve.
2. Setthesupplementalgasflowto15LPMfortheadultandthechild
models;and10LPMfortheinfantmodel.
3. CycletheResuscitatorthroughseveralventilations.Thetestlungshould
inflateduringinspirationanddeflateduringexhalation.Checkfor
leakageatalljointsandconnections.EnsurethattheResuscitatorrefills
promptlyandproperlyandthatallvalvesareoperatingcorrectlyIfnot,
repeatthetestsabovetofindwheretheproblemlies.
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Accessories
1. Masks
 masksfrominfanttoadult(6sizes).
2. Peepvalve
Durable2‐10adjustablepeepvalve. 
Durable5‐20adjustablepeepvalve. 
Diverterforpeepvalve

3. Filter
Toxicgasfilter.(Formilitary,chemistryetc.)
4. Tools
Siliconeextensiontubefornon‐rebreathingvalve. 
Teethopener
Tonguedepressor
Airway
5. CarryandStorage
Wallmountholderforresuscitators.
Siliconehangerforresuscitators. 
Storagecase.
Orderinformation
REF SAPREF Description
2038 AR0051 MR‐100PlusIntakeValveKit
2150 AR0056 MR‐100PlusResuscitatorset,adultw/Pop
2151 AR0057 MR‐100PlusResuscitator,child
2152 AR0058 MR‐100PlusResuscitator,infant
2163 AR0063 MR‐100PlusResuscitator,adult
