GaleMed MR-100 User manual

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GaleMed 
MR‐100
TM
Resuscitator
MR‐100SiliconeReservoirBag,2L
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AR0097(21037)
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InstructionforUse(IFU) 
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2. VersionHistory 
Version# DocumentNo Change Date
1   2020/11/18
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3.ProductDescription 
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3.1IntendedMedicalUse
3.1.1Productname
Resuscitator 
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3.1.2IntendedUse
Provideorassistventilationinpatientswhosebreathingisinadequate. 
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3.1.3Indications
Thedifferentmodelsareindicatedfordifferentpeopleaccordingtotheirweight.
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3.1.4Contraindications
1.Adultresuscitator
Noexistingcontraindicationsforusingresuscitatortoadultpeople.
2.Childresuscitator
Noexistingcontraindicationsforusingresuscitatortochildpeople.
3. Infantresuscitator
a)Meconium‐stainedbabydepressedatbirth
b)Congenitaldiaphragmatichernia
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3.1.5PatientGroup 
Theadultresuscitatorisforpeoplewithabodyweightofmorethan30kg(66lbs.) 
Thechildresuscitatorisforchildrenwithabodyweightbetween7and30kg(15‐66lbs.) 
Theinfantresuscitatorisforinfantswithabodyweightupto7kg(15lbs.)
3.1.6IntendedUser 
Thisproductisintendedforusebyqualifiedmedicaloremergencypersonneltrainedinpulmonary
ventilationandadvancedcardiaclifesupporttechniques.
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3.1.7PrinciplesofOperation
Assemblyviewofanartificialrespirationsystem(A)
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(A) Non‐rebreathing(duckbill)Valve(B)CompressedBag(C)Allin1intakevalve(D)OxygenReservoir.TheOxygen
Reservoirmayberemovedifsupplementaloxygenisnottobesupplied.

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AssemblyView(A)
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PrincipleDrawing(B)–Inspiration
WhencompressingdowntheResuscitator,itcreatethepositivepressureandclosetheIntakeValve(G),the
airinsidethebagpushestheDuckbillValve(E)downward,andblocktheexpirationport(F),anddeliverthe
airintotheSiliconeBagthentothepatientthroughthecenteroftheDuckbillValve,iftheOxygenisinuse,
itshouldbeconnectedby(H)part,thentheOxygenwillfilluptheReservoirthroughtheReservoirValve,
andinstallsintheSiliconeBagthroughtherecoveryinhalemotion,thensenddirectlyintothepatient’s
bodybycompressingthesiliconebag.
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PrincipleDrawing(C)–Exhalation
WhenreleasingtheSiliconeBag(B),pushupwardtheDuckbillValveandkeepitincloseposition,soto
releasetheexhaleairthroughtheExhaleValve(F).
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(A)
(B)
(C)
(D)
(E)
(F)
(K)
(G)
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(E)
(F)
(B) (G) (D)
(H) (I)
(C)

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Atthesametime,theInhaleValve(G)isopenedbytheexpiratorypressurecreatedbyreleasingthebag,
andsendtheairintothebagthroughthetopoftheReservoirValve,andatthesametime,sendthe
OxygenintothebagfromtheOxygenReservoirtillthebagreturnstotheoriginalshapebefore
compressing.ToavoidexcessiveOxygenflowrateandlowcompressingfrequencycausingtoohigh
pressureinsidethebagandtheReservoir,theReservoirValve(I)isspeciallydesignedtoreleasethe
excessiveair,tokeepalow‐rateOxygensupplyandensurethepatient’ssafety
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PrincipleDrawing(D)
GaleMedreusableresuscitatorsareequippedwithpressurereliefvalves(optional),automaticallyprovide
andadjustthepressureinthelung,andkeepitwithin40/60cmH
2
O,anypressureexceedthisstandard
willcausethepressurereliefvalvetojumpoffandpushthepressureouttoensurethepatient’ssafety.
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PressureReliefValveMotion
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Shouldhigherinspiratorypressureberequiredthepressurereliefvalvemaybeoverriddenbyplacingthe
thumbeverthevalveasshowasfollows.
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OverridingthePressureReliefValve
3.1.8DirectionforUse:
3.1.8.1Reusable‐ResuscitatorOperation
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Pressure
ReliefValve
Pressure
ReliefValve
1. Placethepatientonback,pullhischinupwardas
possibletokeeptheairwayandthemouthcavityin
allianceline,sothepatientcanbreathesmoothly. 
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2. Cleanallvisibleforeignmaterialinsidethemouthand
thethroat. 
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3. Inserttheoropharyngealtube,keepthepatient’smouth
opentopreventtonguefromoccludingtheairway.(Can
useamouthopenertoopenhismouth)The
oropharyngealtubecanbeselectedaccordingtothe
patient‘smouthcavitysize. 
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4. Theemergencypersonnelshouldstaybehindthe
patient’shead,extendtheheadbackandpullhischin
upwardsandtowardstheemergencypersonnel.

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‐TestingtheResuscitator
GaleMedreusableresuscitatorshouldbetestedasfollows:
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•WhenfirstusingthenewResuscitator 
•(Aftercleaningandsterilizing)
•Afteranynewpartshavebeenfitted 
•Monthly,iftheResuscitatorisnotfrequentlyused.Equipmentrequired:Testlung,0‐100cmH2O
manometer(forInfantandChildresuscitatorsonly),flowmeter,regulatedgassupply,gassupplytubing.
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3.1.8.2PEEPvalveOperation
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1.FittheFlowDiverteroverthedownstreamhousingontheresuscitatorasshowninthe
illustration.Besurethediverterisfullyseated.
2.PositiontheFlowDiverterasdesiredtodirectexhaledgasesawayfromtherescuer
Remark:Ifthepatientalreadyhasanairwayinnertube
inserted,orhasbeenthroughanairwayexciseresect
operation,thenpleaseremovethemask,connectthe
Non‐rebreathingValveconnectorwiththeairwayinner
tube,thenfollowingthestandardoperatinginstruction.
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5. Coverthepatient’smouthandnosewiththemask,andpress
palmagainstthemasktokeepitclosetothepatient’sface. 
6. UsetheotherhandtopressontheResuscitator,regularly
compresssendingwithsufficientinhale/exhalefrequency.
(Adult:12‐16times,Child:14‐20times,Infant:35‐40times) 
7. Theemergencypersonnelshouldcheck:toensurethatthe
patientisventilatingproperly. 
• Observeriseandfallofthepatient’schest(accordingly
withthepressingontheResuscitator). 
• Checkthepatientslipsandfacecolorthroughthe
transparentpartofthemask. 
• Checkthatthepatientvalveisworkingproperlythrough
thetransparenthousing. 
• Duringexhalation,checkthattheinteriorofthemaskis

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and/orpatient.
3.Squeezetheresuscitatorbagseveraltimestoassurethattheunitisfunctioningproperly.
4.SelectthePeepValvewithappropriaterange(2‐10cmH2Oor5‐20cmH2O)
5.SetthePeepValveknobtotheapproximatevalueshownonthePeepValvehousing.
6.ConnectthePeepValvetotheFlowDiverterportasshownintheillustration.Connect
theresuscitatortoamanometerandtestlung.VentilatethetestlungandadjustthePeep
Valveasrequiredtoobtainthedesiredendexpiratorypressure.
7.VentilatethepatientfollowingACLSproceduresforventilation.Watchthechestrise
duringventilation.Also,duringventilation,periodicallycheckfor:
‐signsofcyanosis;
‐adequacyofventilation;
‐properairwaypressure;
‐secureconnectionofPeepvalveanddiverter.
8.Betweenpatientuseorperiodically,cleanandsterilizethePeepValveandFlowDiverter.
‐TestingtheResuscitator
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3.2SystemOverview 
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3.2.1Intendedforusetogetherwithotherdevices:
OxygenTubing,Airway,SiliconeMask,AircushionMask,PEEPValve,Disposablemanometer
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3.3Specification/Functions
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3.3.1OperatingEnvironmentalTemperatureLimits:
‐18°Cto+50°C
3.3.2StorageEnvironmentalTemperatureLimits:
‐40°Cto60°C(‐104°Fto140°F)
3.3.3Rangeofsetting:
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 AdultResuscitator ChildResuscitator InfantResuscitator
Valveresistance <4.0cmH2O
Oxygen
concentration >95%@15LPM
Bagcapacity(ml) 1500 550 280
Maxdelivered
volume(ml) 1350 350 160
Safetypressure‐
reliefvalve 60±10cmH2O 40±5cmH2O 40±5cmH2O
Reservoirbag(ml) 2000 1000 500
Masksize #4 #3 #0
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DurablePEEPValve
REF SAPREF Productname Pressurerange  Connectorsize Package
2403 AV0035 DurablePEEPValve 2‐10cmH2O 30F(Orange) 1pc/pkg,50
pcs/box

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2413 AV0037 DurablePEEPValve 5~20cmH2O 30F 1pc/pkg,50
pcs/box
2001 AR0003 DurablePEEPValve
Diverter ‐ 30/26mm 1pc/pkg,50 pcs/box
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DisposableManometer
REF SAPREF Description Specification
4524 AP0006 Pressuremanometer,0~60cmH2O 0‐60cmH2O
4526 AP0007 Pressuremanometer,0~30cmH2O 0‐30cmH2O
4527 AP0002 Pressuremanometer,0~20cmH2O 0‐20cmH2O
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3.3.4Connectors:
– Patientvalves:22/15mm
– O2inlet:6M
– Oxygenreservoirbagconnector:22M
– Oxygenreservoirbag:22F
– optionaldiverter:30M
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3.3.5Materiallist:
PARTS MATERIAL
Facemasks Silicone/PSF
Flexiblevalve
parts Silicone
Compressionbags Silicone
Transparentvalve
parts PSF
O2tubing PVC
OxygenReservoir
Bag Silicone&PSF
PEEPvalveall
hardplastic Polysulfone
PEEPvalveand
grommet Silicone
PEEPvalvespring,
screwandshafter.Stainlesssteel

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4.CleaningandDisinfection(Handling)
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Thisproductissinglepatientmultipleuse,pleasedisposeitafterusingit.
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4.1InstructionforCleaningbeforeUse/NextUse
Thisproductissinglepatientmultipleuse,pleasedisposeitafterusingit.
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4.2InstructionforDisinfection/SterilizationbeforeUse/NextUse
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Thisproductissinglepatientmultipleuse,pleasedisposeitafterusingit.
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4.3InstructionforTestingbeforeUse/NextUse
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Testingthesiliconebag 
1.Removethenon‐rebreathingvalveandtheoxygenreservoirandvalve(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thattheintakevalveat
thebaseofthesiliconebagiscorrectlyassembled. 
4.Whilekeepingthenon‐rebreathingvalveoutletblocked,compressthebagagain.Thebagshouldnot
compress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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Testingnon‐rebreathingvalve 
1.Connectthenon‐rebreathingvalvetothesiliconebag.Connectthetestlungtotheoutletonthe
nonrebreathingvalve. 
2.Compressandholdthebag.Thenon‐rebreathing(duckbill)valveinsidethenon‐rebreathingvalve
shouldopenandthetestlungshouldfill.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non‐rebreathing(duckbill)valveshouldcloseandasthetestlungdeflates,gas
shouldflowthroughtheexpiratoryportsinthenon‐rebreathingvalve.Ifnot,checkthatthenon‐
rebreathingvalveiscorrectlyassembled. 
4.Ventilatethetestlungforaminimumof10cyclestoensurethattheResuscitatorisfunctioning
correctly.Inspirationmustoccurwhenthesiliconebagiscompressedandexhalationwhenthebagis
released.Ifnot,checkthatthenon‐rebreathingvalveiscorrectlyassembled.
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Tocheckthefunctionofthepressurereliefvalve(Ifavailable) 
Connecta0‐100cmH2Omanometertothepatientoutletofthenon‐rebreathingvalve.Compressthe
bag.Whenthepressurereliefvalveactivates,themanometershouldread35‐45cmH2O.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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TestingOxygenReservoir/ReservoirValve
1.Attachthereservoirtothereservoirvalveassembly.Attachthesiliconebag. 
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thatthereservoirvalveiscorrectlyassembled. 
4.ConnectthereservoirandreservoirvalveassemblytoaResuscitator. 
5.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thatthereservoirvalveis
correctlyassembled.
Note:Ifsupplementaloxygenisnotconnected,thecompressedbagwillrefillmoreslowlyifthereservoir
isstillattached.
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5.GeneralSafetyInstruction
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5.1OperatingCondition 
5.1.1Careduringshippingandstorage 
‐Forcompactstorage,e.g.,inanemergencycase,theinletendcanbepushedhalfwayintothebag.
‐Neverstoretheresuscitatorinacompressedorfoldedstate.
‐Neverexcessivelysqueezethebagduringstorage.Whentheresuscitatorisreadyforuseitshould
notbekeptindirectsunlightorinaheatedenvironment.
‐Storagetemperature:  -40°C to 60°C (-104°F to 140°F)
‐Forlong‐termstorageortransportation,theresuscitatorshouldbekeptinclosedpackinginacool
placeawayfromdirectsunlight.
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5.2Possibleside‐effect 
Compressedpressurecanincreaseintranspulmonarypressure,thepatient’sbloodpressurecanbereduceddue
toareductioninpre‐load.
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5.3PossibleRisks 
5.3.1ResidualRisk 
0. Hyperventilationmaybeoccurredbythreefactors:thereisnomonitoringofventilatoryparametersonmanual
resuscitators,thereisnodirectevaluationofventilationquality,andthereislimitedunderstandingofthe
patient’sneedsfromrescuerswithlessexperience.
1. Highpressurecancausebarotrauma(injuryfromhighpressure),especiallyforneonatesandprefertouseaBVM
withanintegratedmanometer.
2. Highinspiratorylungvolumes(orpressures)cancauseinjurythroughalveolaroverdistension,causingalveolar
rupture,andcelldeath.

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3. Extrapressureorvolumecancausegastricinsufflation,creatingagreaterriskofaspirationoncertainpatient.  
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5.3.2 Proceduretoavoid 
1.Alwayskeeppeakairwaypressurebelow30cmH2Oandtidalvolumearebasedonpredictedbody
weight,notactualbodyweight.
2.Limitthetidalvolumebychoosingsuitablecompressedbag.
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5.4 Warning/Precaution 
AWarningstatesacondition,hazard,orunsafepracticethatcanresultinseriouspersonalinjuryordeath.
APrecautionstatesacondition,hazard,orunsafepracticethatcanresultinminorpersonalinjuryor
damagetothemanikin.
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Precautions 
•precaution:Federallaw(US)restrictsthisdevicetosalebyorontheorderofaphysician. 
•TheGaleMedreusableresuscitatorshouldonlybeusedbypersonswhohavereceivedadequatetraining
intheuseofresuscitators. 
•Resuscitatorsshouldnotbeusedwithsupplementaloxygenwheresmokingispermittedorwhenfire,
flame,oilorgreaseisincloseproximity. 
•Resuscitatorsshouldnotbeusedintoxicorhazardousatmospheres. 
•Theuseofthird‐partyproductsandoxygendeliverydevices(e.g.filtersanddemandvalves)withthe
GaleMedreusableresuscitatormayhaveaneffectonperformance.Pleaseconsultwiththemanufacturer
ofthethird‐partydevicetoverifycompatibilitywiththeGaleMedreusableresuscitatorandobtain
informationonpossibleGaleMedreusableresuscitatorperformancechanges.

Anoticetotheuserand/orpatientthatanyseriousincidentthathasoccurredinrelationtothedevice
shouldbereportedtothemanufacturerandthecompetentauthorityoftheMemberStateinwhichthe
userand/orpatientisestablished

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6.Symbolglossary 
Symbol Description
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CEmark
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Caution
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Consultinstructionsforuse
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Donotuseifpackageisdamaged
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Use‐bydate
Batchcode
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TemperatureLimit
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Authorized Representative in the European
Community
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Manufacturer
Catalognumber
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GaleMed Corporation 
87, Li-gong 2nd Road, Wu-jia, I-Lan 268, Taiwan 
www.galemed.com Tel: [phone] 
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
EMERGO EUROPE B.V. 
Prinsessegracht 20, 2514 AP The Hague The Netherlands 
[email protected] TEL: (31) (0) 70 345-8570 