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HELIO2 Helium-Oxygen Blender Service Manual Model No. PM5400 Series (shown) PM5500 Series SAVE THESE INSTRUCTIONS 300 Held Drive Tel: (+001) 610-262-6090 Northampton, PA 18067 USA Fax: (+001) 610-262-6080 www.precisionmedical.com

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Page 1: HELIO2 Helium-Oxygen Blender - Precision Medical · 2 Blender SECTION 2: TECHNICAL DESCRIPTION The HELIO 2 Blender is a medical device used to mix Medical Heliox and USP Oxygen into

HELIO2

Helium-Oxygen BlenderService Manual

Model No. PM5400 Series (shown)

PM5500 Series

SAVE THESE INSTRUCTIONS

300 Held Drive Tel: (+001) 610-262-6090Northampton, PA 18067 USA Fax: (+001) 610-262-6080

www.precisionmedical.com

Page 2: HELIO2 Helium-Oxygen Blender - Precision Medical · 2 Blender SECTION 2: TECHNICAL DESCRIPTION The HELIO 2 Blender is a medical device used to mix Medical Heliox and USP Oxygen into

- 1 -HELIO2 Blender

Contents

SECTION 1: SAFETY INFORMATION - WARNINGS AND CAUTIONS .................................2

EXPLANATION OF ABBREVIATION .......................................................... 3

BLENDER DIAGRAMS ............................................................................... 3

COMPONENT DESCRIPTIONS in Blender Diagrams ............................... 4

Example of set-up using a Heliox Cylinder ............................................... 5

SECTION 2: TECHNICAL DESCRIPTION ....................................................................... 6

HELIOX / OXYGEN FLOW PATH INDICATION DIAGRAM ......................... 7

SECTION 3: MAINTENANCE PROCEDURES, REPAIR AND CALIBRATION ................. 8

I. LOW FLOW (PM5400 Model) ................................................................. 8

Step 1: DISASSEMBLY ...........................................................................8

Step 2: CLEANING ................................................................................11

Step 3: LOW FLOW ASSEMBLY ............................................................11

Step 4: TEST .........................................................................................14

Typical Test Configuration Diagram ......................................................14

LOW Flow Operation Verification Procedure ........................................17

II. HIGH FLOW (PM5500 Model) ............................................................... 18

Step 1: DISASSEMBLY ..........................................................................18

Step 2: CLEANING ................................................................................21

Step 3: HIGH FLOW ASSEMBLY ...........................................................21

Step 4: TEST .........................................................................................24

Typical Test Configuration Diagram ......................................................24

HIGH Flow Operation Verification Procedure .......................................27

III. INTERNATIONAL LOW / HIGH Flow Operation Verification Procedure 28

SECTION 5: BLENDER PARTS LIST .............................................................................. 30

Label information ....................................................................................... 31

Page 3: HELIO2 Helium-Oxygen Blender - Precision Medical · 2 Blender SECTION 2: TECHNICAL DESCRIPTION The HELIO 2 Blender is a medical device used to mix Medical Heliox and USP Oxygen into

- 2 -HELIO2 Blender

SECTION 1: SAFETY INFORMATION - WARNINGS AND CAUTIONS

WARNING Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury.

CAUTION Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury.

WARNING• Disconnect the HELIO2 Blender from all connections prior to disassembly.• UseMedicalHelioxandMedicalOxygenwhenservicingtoavoidcontamination.• TheHELIO2Blendershouldbeservicedbyaqualifiedservicetechnician.• AnOxygenAnalyzer/Monitormustbeusedtoverifyoxygenconcentrations.• WhenreassemblingtheBlender,donotpressurizethesystemuntiltheretaining

screwoftheProportioningModulehasbeenfullytightened.The Proportioning Module can be forcefully ejected by gas pressure if not sufficiently tightened.

• AlwaysfollowANSIandCGAstandardsforMedicalGasProducts,Flowmeters andOxygenHandling.• WhenservicingrequirementsofDirective93/42/EECconcerningmedical

devices and all International Standards apply. (On CE marked devices ONLY)• DO NOT obstruct the alarm.• Oxygen Concentration Dial does not rotate 360 degrees. Rotatingthedial

beyondtheendpointsettings,willdamagetheBlender.

Service Warning• ThisServiceManual is provided for your safety and to prevent damage to the

HELIO2 Blender. • Itisessentialtoreadandunderstandthisentiremanualbeforeattemptingtoservice

the HELIO2 Blender.• If you have any questions regarding the installation, setup, operation, and/or

maintenance of the HELIO2Blender,contactPrecisionMedical,Inc.

CAUTION• Userecommendedlubricantssparinglyaslubricantmaymigratetootherareasand

cause the Blender to malfunction.• WhenpressurizingtheBlenderinlets,avoidpressuresurgesgreaterthan 100 psi (6.9 bar).• Besureallconnectionsaretightandleakfreebeforereturningtoservice.• StoreBlenderinaclean,dryareawhennotinuse.• DO NOT steam autoclave.• DO NOTgassterilizewith(EtO)EthyleneOxide.• DO NOT immerse HELIO2 Blender into any liquid.• DO NOT use if dirt or contaminants are present on or around the Blender or

connectingdevices.• DO NOT clean with aromatic hydrocarbons.

Page 4: HELIO2 Helium-Oxygen Blender - Precision Medical · 2 Blender SECTION 2: TECHNICAL DESCRIPTION The HELIO 2 Blender is a medical device used to mix Medical Heliox and USP Oxygen into

- 3 -HELIO2 Blender

EXPLANATION OF ABBREVIATION

FIHe-O2FractionalConcentrationofInspiredHelium-Oxygen

FIO2 FractionalConcentrationofInspiredOxygenHeliox Helium-OxygenDISS Diameter Indexed Safety SystemNIST Non-InterchangeableScrewThreadlpm LitersPerMinutepsi Pounds Per Square InchNm Newton meter

BLENDER DIAGRAMS

DA

CB

FG

E

A

H

D

CB

GF

E

H

Note: PM5480 Model Shown

Page 5: HELIO2 Helium-Oxygen Blender - Precision Medical · 2 Blender SECTION 2: TECHNICAL DESCRIPTION The HELIO 2 Blender is a medical device used to mix Medical Heliox and USP Oxygen into

-4-HELIO2 Blender

ITEM COMPONENT DESCRIPTIONS in Blender Diagrams

APrimary Outlet Port AmaleDISSoxygenfittingwithcheckvalvethatdeliversflowwhenengagedtoanycontrollingdevice,suchasaflowmeter.

BOxygen Inlet FittingAfemaleDISSorNISToxygenfittingwithonewayvalvethatisusedtoconnectanoxygensupplyhose.

CHeliox Inlet FittingAmaleDISSorNISThelioxfittingwithonewayvalvethatisusedtoconnectaheliox supply hose.

D

Oxygen Concentration DialA dial used for selecting oxygen concentrations between 20% -100% or30% -100%.TheFIO2 scale is used for reference only. The actual FIO2 must be verified with an Oxygen Monitor.This Dial does not rotate 360°.Thedialstartsat20%or30%andendsat100%.

E Rear Slide Mount with dove tail.

F

Auxiliary Bleed Collar Thecollarisusedtoengageanddisengagethebleed.Thebleedisnecessarytomaintain accurate FIO2Concentrationbelow15lpmfortheHighFlowand≤ 3 lpm fortheLowFlow.Toactivatethebleed,slideandrotate,(ifapplicable)theknurledcollarbackuntil itcontactsthecover.Todeactivatethebleed,pullandrotate(ifapplicable) collar away from cover until bleedflowvalveisclosed.

G

Auxiliary Outlet Port AmaleDISSoxygenfittingwithcheckvalvethatdeliversflowwhenengagedtoanycontrollingdevice,suchasaflowmeter.Thisoutletisequippedwithableedvalve that allows the user to control if the bleed is ON or OFF. With the bleed in theONposition, thisoutletdeliversaccurateoxygenconcentrations in thefollowingflows:

Model Flow RangeHighFlow 2 – 100 lpmLow Flow 0 – 30 lpm

HAlarm An audible alarm that sounds due to an excessive pressure drop or deletion of eithergassupply.

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WARNING• WhenpressurizingtheBlenderinletsavoidpressuresurgesgreaterthan100psi(6.9bar).• AlwaysuseahelioxregulatorwhenusinghelioxcylinderstosupplygastotheHeliox

inlet of the Blender.• Alwaysuseanoxygenregulatorwhenusingoxygencylinderstosupplygastothe

oxygenInletoftheBlender.

example of set-up using a Heliox CylinderNOTE: Heliox regulator in use.

Page 7: HELIO2 Helium-Oxygen Blender - Precision Medical · 2 Blender SECTION 2: TECHNICAL DESCRIPTION The HELIO 2 Blender is a medical device used to mix Medical Heliox and USP Oxygen into

- 6 -HELIO2 Blender

SECTION 2: TECHNICAL DESCRIPTIONThe HELIO2BlenderisamedicaldeviceusedtomixMedicalHelioxandUSPOxygenintoagassourcerangingfrom20-100%or30-100%oxygen.TheinletgasconnectionsarestandardDISSorNISTforeachgas.TheinletsareclearlymarkedandlabeledonthebottomoftheBlender.TheoutletsarestandardDISSmaleoxygenconnections.ThefrontpaneloftheBlenderhasadialthatisusedtosetthespecificFIO2blend.Thedialsettingsrangefrom20-100%onthePM5480&PM5580modelsand30-100%onthePM5470&PM5570models.The Path of the GasesThesupplyentersthroughthehelioxandoxygeninletconnectorslocatedonthebottomoftheBlender.Eachinletconnectorcontainsaparticulatefilterandduckbillcheckvalveswhichpreventpossiblereversegasflow.Diaphragm Housing ModuleThetwogasesthenenterthetwo-stagepressureDiaphragmHousingModule.Inthismodule,thepressuresofbothgassourcesareequalizedpriortoenteringtheProportioningModule.Thepressureisequalizedat the lowerpressure. Thediaphragmwithin themoduleresponds to thedifferenceinpressureanddirects themovementofeachcheckvalveassemblycontainedwithin thehelioxandoxygenchambers.ThemovementofeachballadjuststheamountofgasflowingthroughtheDiaphragmHousingModule,equalizingthehelioxandoxygenpressurestothelowerpressure.Proportioning ModuleFromtheDiaphragmHousingModulethegasesflowintotheProportioningModuleandaremixedaccordingtotheoxygenpercentageselectedontheOxygenConcentrationDial.TheProportioningModuleconsistsofadoubleendedvalvepositionedbetweentwovalveseats.Oneseatcontrolsthepassageofhelioxandtheothervalveseatcontrolsthepassageofoxygenintotheoutlet.Atthispoint,thetwogaseshavebeenblendedaccordingtotheoxygenpercentageselectedontheOxygenConcentrationDial.TheOxygenConcentrationDialinthefullcounterclockwiseposition(20/30%),willcompletelycloseofftheflowofoxygen,allowingonlytheOxygenConcentrationDialinthefullclockwiseposition(100%),willblocktheflowofheliox,permittingonlytheflowofoxygenthroughtheBlenderoutlet.Alarm and Alarm BypassAnaudiblealarmlocatedonthebottomoftheBlendersignalswhenthedifferenceinpressurebetweenthetwoinletgasesis≥ 18 psi for Low Flow and ≥13psiforHighFlow.Whenthesourcegasesarenearequalpressure,thealarmbypasspoppetwillremainseatedoverthealarmchannelandthealarmdoesnotsound.Whenthegaspressuresbecomeunbalancedthehigherpressuregaswillunseatthepoppetbyovercomingthespringforcecausinggastoflowthroughthealarmchannelandthealarmsounds.TheoxygenconcentrationfromtheBlenderwillbethatofthehighergaspressure.TheBlenderinthealarm/bypassmodewilldelivertheoxygen(100%)orhelioxuntilthebypassmechanismresetswhenthesourcegaspressureisrestoredtoadifferentialofapproximately6psi(0.42kg/cm2).IftheBlenderissetat20or30%(dependingonmodel),theOXYGENsourcepressureisreducedorlost,theunitwillnotalarmbecauseitwillcontinuetodeliver20or30%concentrationaccordingtothesetting.Ifthecontrolismovedslightlyfromthe20or30%setting,thealarmwillsound.Similarly,iftheBlenderissettodeliver100%oxygenconcentration and heliox source pressure is reduced or lost, the unit will not alarm because it will continuetodelivertheselected100%concentration. The alarm will not function when there is no flow to the blender.

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- 7 -HELIO2 Blender

Gas OutletsThePrimaryandAuxiliaryOutletsareDISSmaleadapterswithcheckvalves.

HELIOX / OXYGEN FLOW PATH INDICATION DIAGRAM

Heliox(DISS shown)

DIAPHRAGMDIAPHRAGM

CHECKVALVE

DUCKBILLCHECKVALVEFILTER

PROPORTION-INGVALVE

ORIFICE

BYPASS CHECKVALVE

ALARMBYPASSVALVE

O2

(DISS shown)

AUDIBLEALARM

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SECTION 3: MAINTENANCE PROCEDURES, REPAIR AND CALIBRATION

I. LOW FLOW (PM5400Model) Step 1: DISASSEMBLY

Tools Required

#2 Phillips Screwdriver #3 Phillips Screwdriver 1/2in.OpenEndWrench SpannerWrench(P/N504839)

11/32in.NutDriver5/32in.LongHexKeySmallRetainingRingpliers

Figure A1.Rotatedial[1]tothe12o’clockposition.2.Removethetwoflatheadscrews[2]oneach

side of the top cover [3].3.Removetopcoverbypullingupwards.

The cover will not come off unless the dial is at the 12 o’clock position.

[1]

[2]QUANTITY-4

[3]

Figure B4. Usea½in.openendwrenchtounscrewand

remove the heliox [4] and oxygen [5] inletassemblies from bottom of the Blender. Oxygen inlet has left hand threads.

5. If manifold outlet assembly is present,unscrewthestemusinga5/32hexkeyandholdingthemanifoldoutletassemblytothebottom of the Blender.

6. Removethefourflatheadscrews[2]frombottom cover [6].

7. Remove bottom cover.

[5]

[4]

[2]QUANTITY-4

[6]

Page 10: HELIO2 Helium-Oxygen Blender - Precision Medical · 2 Blender SECTION 2: TECHNICAL DESCRIPTION The HELIO 2 Blender is a medical device used to mix Medical Heliox and USP Oxygen into

- 9 -HELIO2 Blender

LOW FLOW Figure C8.Remove dial [7] by pulling dial away from

manifoldblock[8].9. Remove the primary [9] and auxiliary [10]

outlets(auxiliarycontainsBlueMuffler[38])byusinga½ in. open end wrench to unscrew.

10. Usespannerwrench(P/N504839)tounscrewand remove audio alarm assembly [11] from thebottomofthemanifoldblock.

[8]

[10]

[11][9]

[7]

[38]contained in [10]

Figure D11.Use small retaining ring pliers to remove

retainingrings[12]fromeachsideofthealarmassembly [13]. Push the alarm assembly throughtoremovetheassemblyfrommanifoldblock.

[12]QUANTITY - 2

[13]

Figure E12.Usinga11/32in.nutdriverorsocket,loosen

the nut [14] (ONLY two turns) holding theknob guide [15] on the proportioning valveassembly [16]. Slide knob guide assemblyfromproportioningvalveassemblyshaft.Slideresistancering[17]fromproportioningvalveassembly.

13. Remove phillips head screw [18] and washer [19]fromsideofproportioningvalveassembly.

14.Replaceknobguideassemblyandtightenthe nut.

15.Pull knob guide assembly to removeproportioningvalveassembly frommanifoldblock.Again,loosenthenut(ONLY two turns) holding the knobguide to theproportioningvalve assembly, remove knob guide fromproportioningvalveassemblyshaft.

[14][15]

[16][18]

[19]

[17]

Page 11: HELIO2 Helium-Oxygen Blender - Precision Medical · 2 Blender SECTION 2: TECHNICAL DESCRIPTION The HELIO 2 Blender is a medical device used to mix Medical Heliox and USP Oxygen into

- 10 -HELIO2 Blender

LOW FLOW Figure F16.Removeeachdiaphragmhousingassembly

[20] from themanifold by removing the twohexsocketheadscrews[21]onthetopofeachdiaphragmhousingwith5/32hexkey.

[20]QUANTITY - 2

[21]QUANTITY-4

Figure G17. Using5/32in. longhexwrench,unscrewand

removeplug[22]fromthebottomandbackofthemanifoldblock.

18.Remove rear plug [22] from thebackof themanifold block. Insert a long 5/32 hex keythrough rear plug opening, unscrew andremovethealarmbypassbody[23],ball[24]andspring[25].

QUANTITY - 2

[23][25]

[24] [22]

[22]

Figure H19. RemoveanddiscardthetwoO-rings[26]fromthe

bottomofeachofthediaphragmhousings[27].20.Removethefourhexsocketheadscrews[28]

holdingdiaphragmhousingstogether.21.Removeanddiscardthediaphragm[29].22.Usingspannerwrench,removeanddiscard

checkvalves[30].Ensure inner O-ring is removed from diaphragm housing.NOTE: Ifcheckvalve[30]comesapartwhen

removingitfromdiaphragmhousing,a¼ in. hex wrench or (#3 Phillips Screwdriver) will be needed to complete removal of the checkvalvefromthediaphragmhousing.

23.Repeatsteps19-22fortheremainingdiaphragmhousingassembly.

24.Make sure all O-rings have been removed from diaphragm housings and check valves.

25.Disassemblyiscomplete.26.Manifoldblockanddiaphragmhousingmaybe

ultrasonically cleaned.

[27]

[26]

QUANTITY - 2

QUANTITY-4

[28]QUANTITY-4

[29]

[30]QUANTITY- 2

[36]QUANTITY -2

Page 12: HELIO2 Helium-Oxygen Blender - Precision Medical · 2 Blender SECTION 2: TECHNICAL DESCRIPTION The HELIO 2 Blender is a medical device used to mix Medical Heliox and USP Oxygen into

- 11 -HELIO2 Blender

Step 2: CLEANINGPrecisionMedical,Inc.recommendsusinganultrasoniccleanerforcleaningallnon-elastometric andnon-metallic components.However, cleaningwith anall-purposeliquidcleanerandrinsingwithclean,warmwatermaybesubstituted.Bothmethodsrequirethoroughly blowdrying all passages before reassembly. Follow the ultrasonic cleanermanufacturer instruction.

Step 3: LOW FLOW ASSEMBLY

Tools Required Lint Free Swab (optional)

PointedinstrumentforremovingO-ringsKrytoxGPL106orequivalent

Oxygensafelubricant#2 Phillips Screwdriver

1/2in.OpenEndTorqueWrench(Torque wrench(s) capable of 60 in-lbs and 10 ft-lbs)

11/32in.NutDriver5/32in.LongHexKey

SpannerWrench(P/N504839)SmallRetainingRingPliers

Tools Supplied with Kit DiaphragmAlignmentTool

(P/N504838)

Figure I1.Positionmanifoldblocksothatthemountingbracketisfacingup.Thelargeholesoppositethemountinglocationsofthediaphragmhousingassembliesarefacingyou.

2.ReplaceO-ring[31]onalarmbypassbody[23].3.Cover the alarm assembly thread locationwith

thumb.Dropspring [25] thenball [24] intoalarmbypassorifice.

4.Placealarmbypassbodyontolongshaftof5/32hex key.Guide the alarmbypass body, threadsfirstintothealarmbypassorifice,screwintocavity.Tightenuntilalarmbypassbodyisflushwithbottomof center hole. Tighten enough to clear center threads ONLY.

5.ReplaceO-ring[32]onplug[22].Insertplugandtighten.

[32]

[23]

[31][25]

[24][22]

Page 13: HELIO2 Helium-Oxygen Blender - Precision Medical · 2 Blender SECTION 2: TECHNICAL DESCRIPTION The HELIO 2 Blender is a medical device used to mix Medical Heliox and USP Oxygen into

- 12 -HELIO2 Blender

LOW FLOWFigure J 6.Assemblingdiaphragmhousingassemblies.

a.EnsureallO-ringshavebeenremovedfromdiaphragmhousing.

b.Placediaphragmalignmenttool throughcenterholeofonediaphragmhousing.

c.Placenewdiaphragm[29]ontopofdiaphragmhousing,ensure center pin of diaphragm is in the center ofdiaphragmalignmenttool(P/N504838).

d.Placeotherdiaphragmhousingon topof theonewiththediaphragm.Ensuretheinletholesofthediaphragmhousingsareonthesameside.

e. Fastenthetwodiaphragmhousingstogetherusingfourhexsocketheadscrews[28].Torquescrewsto60in-lbs.

f. Place four newO-rings [26] on the inlet holes of thediaphragmhousings.

g.Removediaphragmalignmenttool.h. PlacenewO-rings[36]ontoeachcheckvalve[30].i. By hand, carefully insert new check valve [30] into

diaphragmhousing.(Check valves are double threaded) Thread check valves into diaphragm housing usingspannerwrench.Checkvalvemustbeflushwithsurfaceofdiaphragmhousing.DO NOT USE power tool to tighten. Repeatthisstepforthesecondcheckvalve.

j. Usingtwolonghexsocketheadscrews[21]secureeachdiaphragm housing assembly to themanifold block.Torque to 60 in-lbs (6.8 Nm).

k.Repeat steps a - i for remaining diaphragmhousingassembly.

[28]QUANTITY-4

[29]

[26]QUANTITY-4

[30]QUANTITY - 2

[21]QUANTITY - 2

[36]QUANTITY - 2

DiaphragmAlignment

Tool

Figure K7. Lubricate alarm bypass assembly bore on manifold

blockwithKrytoxGPL106.8.Usingretainingringpliersinstallretainingring[12]in

one side of alarm assembly bore.9.Insertalarmassembly[13]intoboreofmanifoldblock.10.Installremainingretainingring.11. For Models without manifold block assembly: ReplaceO-ring[32]onplug[22]theninstallplug[22]

intobottomholeofmanifoldblock.12. Thread auxiliary outlet assembly [10] to manifold

block,torqueto10ft-lbs(13.6Nm).[12]

QUANTITY - 2

[10]

[13][32]

[22]

Page 14: HELIO2 Helium-Oxygen Blender - Precision Medical · 2 Blender SECTION 2: TECHNICAL DESCRIPTION The HELIO 2 Blender is a medical device used to mix Medical Heliox and USP Oxygen into

- 13 -HELIO2 Blender

LOW FLOWFigure L13.Remove and discard outerO-ring [32] from

primary outlet assembly.14.Extrudestem[33]fromprimaryoutletassembly

toexposeO-ringonthestem.15.RemoveO-ring[34]fromstem.16.Discardandreplacespring[35].17.Reinsertstem[33]withnewspringintoprimary

outletbody[37].Extrudestemandinstall O-ring[34].18.ReplaceO-ring[32]onoutsideofprimaryoutlet

body [37].19. Reinstall primary outlet assembly torque to

10 ft-lbs (13.6 Nm).

[32]

[33] [35]

[34]

[37]Primary Outlet Assembly

Figure M20. Start threads of new alarm assembly [11] by hand,

tightenwithspannerwrench,ensurenottobendreed.

21.Attach bottom cover [6] using four flat headscrews [2].

22.Installnewoxygeninletassembly[5]torqueto10 ft-lbs (13.6 Nm). Oxygen inlet assembly has left handed threads.

23.Installnewhelioxinletassembly[4],torqueto 10 ft-lbs (13.6 Nm).

[6]

[2]QUANTITY-4

[4]

[5]

[11]

Spanner Wrench(P/N504839)

Figure N24. LubricateproportioningvalveborewithKrytoxGPL106.25. Alignthe(3)holesontheproportioningvalveassembly

[16]equaldistancebetweenthe(2)plugsandpushin.*Referencedrawingbelow.

26. Replace washer [19] and phillips head screw [18].27. Place new resistance ring [17] in its place on the

proportioningvalveassembly.*Proportional valve assembly inserted, with the

“L” stamped on back for Low Flow Model.plugs

[16]

[18][19]

[17]

The “L” is stamped on the back for LOW Flow models

Page 15: HELIO2 Helium-Oxygen Blender - Precision Medical · 2 Blender SECTION 2: TECHNICAL DESCRIPTION The HELIO 2 Blender is a medical device used to mix Medical Heliox and USP Oxygen into

-14-HELIO2 Blender

Step 4: TEST

Equipment Required MedicalHelioxSupplyMedicalOxygenSupply

CalibratedOxygenAnalyzer/MonitorFlowmeter0to70lpmorgreater

CalibratedPressureGauges0to100psiRegulators/Tubing/Hoses

Tools RequiredPhillips Screwdriver

Torque Driver capable of 10 in-lbsAdjustable WrenchRetainingRingPliers

Nut Driver

Typical Test Configuration Diagram

Compressed Heliox Supply

Adjustable 0-100 psi

(0-6.89 bar)

PressureGauge0-100 psi

(0-6.89 bar)

BlenderPressureGauge

0-100 psi(0-6.89 bar)

OxygenSupply

Adjustable 0-100 psi

(0-6.89 bar)

OxygenAnalyzer

OxygenFlowmeter0-70 lpm

T-Fitting

INSTRUCTIONS FOR TESTINGA. Heliox and Oxygen Supply Setup

Bothgassuppliesmustbecleananddryperthespecificationsoutlinedinthismanualandhavetheabilitytogenerateupto100psi(6.89bar)forboththehelioxandoxygeninletpressures.Verifyandrecordthevalueofthehelioxtankconcentrationpriortoconnectinghelioxhosetotank.

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-15-HELIO2 Blender

B. Blender Setup1. MounttheBlenderintoasecuredmatingwallorpolebracketinanuprightposition.2. SecurethehelioxandoxygenhosestothecorrespondingBlenderinlets.3. Attachaoxygenflowmetercapableof0-70lpmtotheauxiliaryoutletonthe

Blender.4. Attachat-fittingtotheoutletoftheflowmeter.5. AttachanOxygenAnalyzer/Monitortotheoneoutletonthet-fitting.6. The system is now ready for an initial performance test.

C. Initial Performance TestNOTE: Beforepressurizing,makesureproportioningvalveassembly issecureand

screwistightened.1.PerformcalibrationonOxygenAnalyzer/Monitorperthemanufacture’sinstructionspriortotestingtheBlender.

2.Sethelioxandoxygenpressuresto50psi(3.45bar)each.NOTE:TurnOFFandcheckforleakbywatchingforpressuredropsonpressure

gauges.AssureBleedFlowValveisnotengaged.3. An initial pressure drop may occur, no further drop in pressure should occur.4.Ifcontinuedpressuredropisobserved,troubleshootbyusingacommercialleakdetectortofindsourceofleakandrefertoSection4:TROUBLESHOOTINGforfurther instructions.

5.UsealintfreedryclothtowipeBlendercleanofcommercialleakdetector.6.Ensurebothinletpressuresareat50psi.7. Replace the top cover.

NOTE: DONOTinstallthefour(4)mountingscrewsuntiltheendoftheFinalTest,oraftersatisfactorycompletionofthePerformanceCheck.Refertothe“OPERATINGINSTRUCTIONS”inUsersManual.

8.Setflowmeterto3-3.5lpm.9. Set theBlender to60%FIO2withOxygenAnalyzer/Monitor, this valueshould

remainwithin3.0%oforiginalreadingthroughoutthefollowingtest.a.Setflowmeterto30-30.5lpm,checkconcentrationreading.b.Setflowmeterbackto3-3.5lpm.c. Sethelioxinletpressureto50psi(3.45bar)andtheoxygeninletpressureto

43psi(2.96bar)adjustflowto3-3.5lpm,checkconcentrationreading.d.Sethelioxinletpressureto43psi(2.96bar)andtheoxygeninletpressureto

50psi(3.45bar)adjustflowto3-3.5lpm,checkconcentrationreading.e. If theOxygenAnalyzer/Monitor settingdoesnot remainwithin 3.0%of the

originalreading,thenreplaceoneorbothdiaphragmhousingassemblies.

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- 16 -HELIO2 Blender

D. Reverse Gas Flow Procedure(ReferenceOperationalVerificationProcedure#’s2&3inTable,page17or28).

1. AssureBleedFlowValveisnotengaged. Disconnecttheoxygenhosefromthegassource.RemovealloutletconnectionsfromtheBlendertoensurethatthereisnooutletflow.

2. Placethefreeendoftheoxygensupplyhoseunderwater.Graduallyincreasethe heliox supply pressure from 30 -75psi(2.07-5.17bar),checkforleakagepasttheoxygeninletcheckvalve.

3. ReplacetheDuckbillCheckValveintheoxygeninletifleakageis>100ml/min.4. Repeatsteps1-3tocheckforleakagepastthehelioxinletcheckvalve.5. Reconnectthehelioxinlethoseandadjustbothsupplypressuresbackto

standard inlet pressure.

E. Setup of PROPORTIONING VALVE ASSEMBLY1. Sethelioxandoxygeninletpressuresto50psi(3.45bar).2. Setflowto15lpm,measuredwithoxygenflowmeter.3. Turn Adjustment Shaft counterclockwiseuntiltheOxygenAnalyzer/Monitordisplays

a concentration equal to that of the source heliox (±0.3), reference Part A in Setup.4. Attachknobguideassemblyontoadjustmentshaftofproportioningvalveassembly

sothattheknobstoprestsagainstthescrew.Ensureknobstopalignswiththeslotintheresistancering.

5. Whileapplyingdownwardpressuretothetwo(2)screwsontheknobguideassembly,attachnuttoadjustmentshaftusingnutdriver.

6. Turnknobguidefullyclockwise,OxygenAnalyzer/Monitordisplayshouldbeequaltoconcentrationofsourceoxygen(±0.3).

7. Turnknobguidebackto20or30%positiontoensurenodriftfromoriginalreading(±0.3).

8. Torquenuttoadjustmentshaftandtightento10in-lbsusingatorquedriver.9. Snapinknobbackintoknobguide,paycloseattentiontothekeylocationofthe

knob.10.Setknobto12o’clockposition.11. Replace the top cover. NOTE: DONOTinstallthefour(4)mountingscrewsuntiltheendoftheFinalTest.

F. Final Test CompleteOperationVerificationProcedureasperthetesttable,page17or28. Record test results in the test table. WhenFinalTestiscompletereplacetopcoverandinstallthefour(4)mountingscrews

into cover.

NOTE: OperationVerificationProcedureshouldbeperformedatleastonceayear.

Page 18: HELIO2 Helium-Oxygen Blender - Precision Medical · 2 Blender SECTION 2: TECHNICAL DESCRIPTION The HELIO 2 Blender is a medical device used to mix Medical Heliox and USP Oxygen into

- 17 -HELIO2 Blender

USAandCANADAONLYLOW Flow Operation Verification Procedure

(50psi/3.45barMODELS)Serial No.

SEQ#

DIAL SET

Oxygen%

OXYGEN PRESS

±1.0

HELIOXPRESS

±1.0FLOWMETER

SET TOlpm ±0.2

AUXILIARYBLEED FUNCTION TARGET

VALUEACTUALVALUE

psi bar psi bar

1 ANY 50 3.45 50 3.45 closed closed leak <2 psi / 2MIN

*2 60 75 5.17 0 0 0 closed backflow <100ml/min

*3 60 0 0 75 5.17 0 closed backflow <100ml/min

4 20 or 30 50 3.45 50 3.45 3 open end point (±0.3) Source Value

5 40 50 3.45 50 3.45 3 open set point 37.0%-43.0%

6 60 50 3.45 50 3.45 3 open set point 57.0%-63.0%7 80 50 3.45 50 3.45 3 open set point 77.0%-83.0%

8 100 50 3.45 50 3.45 3 open end point (±0.3) Source Value

9 60 50 3.45 50 3.45 1 open set point 57.0%-63.0%10 60 60 4.14 67 4.62 1 open set point 57.0%-63.0%11 60 60 4.14 50 3.45 1 open set point 57.0%-63.0%

12 60 50 3.45Slowly reduce to 30

Slowly reduce to 2.07

3 closed Alarm ON

30.0± 2.0 psi

13 60 50 3.45

SlowlyIncrease

until alarm shuts off

3 closed Alarm OFF

45.0psiMAX

14 60Slowly

Reduce to 30

Slowly Reduce to 2.07

50 3.45 3 closed Alarm ON

30.0± 2.0 psi

15 60

SlowlyIncrease

until alarm shuts off

50 3.45 3 closed Alarm OFF

45.0psiMAX

16 60 50 3.45 50 3.45 MAX closed flowrate 30.0 lpm MIN

17 60 50 3.45 0 MAX closed flowrate 30.0 lpm MIN

18 60 0 50 3.45 MAX closed flowrate 30.0 lpm MIN

19 60 50 3.45 50 3.45 MAX open flowrate 30.0 lpm MIN

*Reference,LetterD.(ReverseGasFlowProcedure)

Page 19: HELIO2 Helium-Oxygen Blender - Precision Medical · 2 Blender SECTION 2: TECHNICAL DESCRIPTION The HELIO 2 Blender is a medical device used to mix Medical Heliox and USP Oxygen into

- 18 -HELIO2 Blender

II. HIGH FLOW (PM5500Model) Step 1: DISASSEMBLY

Tools Required

#2 Phillips Screwdriver #3 Phillips Screwdriver 1/2in.OpenEndWrench SpannerWrench(P/N504839)

11/32in.NutDriver5/32in.LongHexKeySmallRetainingRingpliers

Figure A1. Rotatedial[1]tothe12o’clockposition.2. Removethetwoflatheadscrews[2]oneach

side of the top cover [3].3. Removetopcoverbypullingupwards. The cover will not come off unless the dial

is at the 12 o’clock position.

[1]

[2]QUANTITY-4

[3]

Figure B4.Usea½ in. open end wrench to unscrew and removetheheliox[4]oxygen[5]inletassembliesand primary [9] outlet assemblies from bottom of the Blender. Oxygen inlet has left hand threads.

5.Ifmanifoldoutletassemblyispresent,unscrewthestemusinga5/32hexkeyandholdingthemanifold outlet assembly to the bottom of the Blender.

6.Removethefourflatheadscrews[2]frombottom cover [6].

7. Remove bottom cover.

[5]

[4]

[2]QUANTITY-4

[6]

[9]

Page 20: HELIO2 Helium-Oxygen Blender - Precision Medical · 2 Blender SECTION 2: TECHNICAL DESCRIPTION The HELIO 2 Blender is a medical device used to mix Medical Heliox and USP Oxygen into

- 19 -HELIO2 Blender

HIGH FLOW

Figure C 8.Removedial [7]bypullingdialaway from

manifoldblock[8].9. Remove the auxiliary [10] outlets (auxiliary

containsBlueMuffler[38])byusinga½ in. open end wrench to unscrew.

10. Use spanner wrench (P/N 504839) tounscrew and remove audio alarm assembly [11]fromthebottomofthemanifoldblock.

[8]

[10]

[11]

[7]

[38]contained in [10]

Figure D11.Use small retaining ring pliers to remove

retaining rings [12] fromeach sideof thealarm assembly [13]. Push the alarm assemblythroughtoremovetheassemblyfrommanifoldblock.

[12]QUANTITY - 2

[13]

Figure E12.Usinga11/32in.nutdriverorsocket,loosen

thenut[14](ONLY two turns)holdingtheknobguide[15]ontheproportioningvalveassembly[16].Slideknobguideassemblyfromproportioning valve assembly shaft.Slideresistancering[17]fromproportioningvalve assembly.

13. Remove phillips head screw [18] and washer[19]fromsideofproportioningvalveassembly.

14.Replaceknobguideassemblyandtightenthe nut.

15.Pull knob guide assembly to removeproportioningvalveassemblyfrommanifoldblock.Again,loosenthenut(ONLY two turns) holdingtheknobguidetotheproportioningvalve assembly, remove knob guide fromproportioningvalveassemblyshaft.

[14][15]

[16][18]

[19]

[17]

Page 21: HELIO2 Helium-Oxygen Blender - Precision Medical · 2 Blender SECTION 2: TECHNICAL DESCRIPTION The HELIO 2 Blender is a medical device used to mix Medical Heliox and USP Oxygen into

- 20 -HELIO2 Blender

HIGH FLOWFigure F16.Removeeachdiaphragmhousingassembly[20]

fromthemanifoldbyremovingthetwohexsocketheadscrews[21]onthetopofeachdiaphragmhousingwith5/32hexkey.

[20]QUANTITY - 2

[21]QUANTITY-4

Figure G17. Using5/32in.longhexwrench,unscrewandremove

plugs[22]fromthesideandbackofthemanifoldblock.(ForHighFlowmodelswithamanifoldoutletassembly removeplug from left sideofmanifoldblock insteadof from thebottomof themanifoldblock.)

18.Removerearplug[22]fromthebackofthemanifoldblock.Insertalong5/32hexkeythroughrearplugopening,unscrewand remove thealarmbypassbody[23],ball[24]andspring[25].

QUANTITY - 2

[23][25]

[24] [22]

[22]

[22]

Figure H19.RemoveanddiscardthetwoO-rings[26]fromthe

bottomofeachofthediaphragmhousings[27].20.Remove the four hex socket head screws [28]

holdingdiaphragmhousingstogether.21. Removeanddiscardthediaphragm[29].22.Usingspannerwrench,removeanddiscardcheck

valves [30]. Ensure inner O-ring is removed from diaphragm housing.NOTE: If check valve [30] comes apart when

removingitfromdiaphragmhousing,a¼ in. hex wrench or (#3 Phillips Screwdriver) will beneededtocompleteremovalofthecheckvalvefromthediaphragmhousing.

23.Repeatsteps19-22fortheremainingdiaphragmhousingassembly.

24.Make sure all O-rings have been removed from diaphragm housings and check valves.

25.Disassemblyiscomplete.26.Manifoldblockmaybeultrasonicallycleaned.

[27]

[26]

QUANTITY - 2

QUANTITY-4

[28]QUANTITY-4

[29]

[30]QUANTITY- 2

[36]QUANTITY -2

Page 22: HELIO2 Helium-Oxygen Blender - Precision Medical · 2 Blender SECTION 2: TECHNICAL DESCRIPTION The HELIO 2 Blender is a medical device used to mix Medical Heliox and USP Oxygen into

- 21 -HELIO2 Blender

Step 2: CLEANING

PrecisionMedical,Inc.recommendsusinganultrasoniccleanerforcleaningallnon-elastometriccomponents.However,cleaningwithanall-purposeliquidcleanerandrinsingwithclean,warmwatermaybesubstituted.Bothmethodsrequirethoroughlyblowdryingallpassagesbeforereassembly.Followthemanufacturer’sinstructionforultrasoniccleaning.

Step 3: HIGH FLOW ASSEMBLY Tools Required

Lint Free Swab (optional)PointedinstrumentforremovingO-rings

KrytoxGPL106orequivalentOxygensafelubricant#2 Phillips Screwdriver

1/2in.OpenEndTorqueWrench(Torque wrench(s) capable of 60 in-lbs and 10 ft-lbs)

11/32in.NutDriver5/32in.LongHexKey

SpannerWrench(P/N504839)SmallRetainingRingPliers

Tools Supplied DiaphragmAlignmentTool

(P/N504838)

Figure I1.Positionmanifoldblocksothatthemountingbracketisfacingup.Thelargeholesoppositethemountinglocationsofthediaphragmhousingassembliesarefacingyou.

2.ReplaceO-ring[31]onalarmbypass[23].3.Coverthealarmassemblythreadlocationwiththumb.

Dropspring[25]thenball[24]intoalarmbypassorifice.

4.Placealarmbypassonto long shaft of 5/32hex key.Guide the alarmbypass, threads first into the alarmbypass orifice, screw into cavity.Tighten until alarmbypassisflushwithbottomofcenterhole.

Tighten enough to clear center threads ONLY.5.ReplaceO-ring[32]onplug[22].Insertplugand

tighten.

[32]

[23]

[31][25]

[24][22]

Page 23: HELIO2 Helium-Oxygen Blender - Precision Medical · 2 Blender SECTION 2: TECHNICAL DESCRIPTION The HELIO 2 Blender is a medical device used to mix Medical Heliox and USP Oxygen into

- 22 -HELIO2 Blender

HIGH FLOWFigure J 6.Assemblingdiaphragmhousingassemblies.

a.EnsureallO-ringshavebeenremovedfromdiaphragmhousing.

b. Placediaphragmalignmenttoolthroughcenterholeofonediaphragmhousing.

c. Placenewdiaphragm[29]ontopofdiaphragmhousing,ensurecenterpinofdiaphragmisinthecenteroftool.

d.Placeother diaphragmhousingon topof theonewiththediaphragm.Ensuretheinletholesofthediaphragmhousingsareonthesameside.

e. Fastenthetwodiaphragmhousingstogetherusingfourhexsocketheadscrews[28].Torquescrewsto60in-lbs.

f. Place four newO-rings [26] on the inlet holes of thediaphragmhousings.

g.Removediaphragmalignmenttool.h. PlacenewO-rings[36]ontoeachcheckvalve[30].i. Byhand,carefullyinsertnewcheckvalve[30]intodiaphragm

housing.(Check valves are double threaded). Thread into diaphragmhousingusing spannerwrench,Check valvemustbeflushwithsurfaceofdiaphragmhousing.DO NOT USE power tool to tighten. Repeat this step for the second checkvalve.

j. Usingtwolonghexsocketheadscrews[21]secureeachdiaphragmhousingassemblytothemanifoldblock.Torqueto 60 in-lbs (6.8 Nm).

k.Repeat steps a - i for remaining diaphragm housingassembly.

[28]QUANTITY-4

[29]

[26]QUANTITY-4

[30]QUANTITY - 2

[21]QUANTITY - 2

[36]QUANTITY - 2

DiaphragmAlignment

Tool

Figure K7. Lubricate alarm bypass assembly bore on manifold

blockwithKrytoxGPL106.8.Usingretainingringpliersinstallretainingring[12]in

one side of alarm assembly bore.9.Insertalarmassembly[13]intoboreofmanifoldblock.10.Installremainingretainingring.11.Threadauxiliaryoutletassembly[10]tomanifoldblock,

torque to 10 ft-lbs (13.6 Nm).

[12]QUANTITY - 2

[10]

[13]

Page 24: HELIO2 Helium-Oxygen Blender - Precision Medical · 2 Blender SECTION 2: TECHNICAL DESCRIPTION The HELIO 2 Blender is a medical device used to mix Medical Heliox and USP Oxygen into

- 23 -HELIO2 Blender

HIGH FLOWFigure L12.ReplaceO-ring[32]onplug[22].Installplugand

tighten.

[22]

[32]

Figure M13. Start threads of new alarm assembly [11] by hand,

tightenwithspannerwrench,ensurenottobendreed.14. Attachbottomcover[6]usingfourflatheadscrews[2].15. Installnewhelioxinletassembly[4],torqueto10ft-lbs

(13.6 Nm).16. Installnewoxygeninletassembly[5]torqueto10ft-lbs

(13.6 Nm). Oxygen inlet assembly has left handed threads.

17. RemoveanddiscardouterO-ring[32]fromprimaryoutletbody [37].

18. Extrudestem[33]fromprimaryoutletbody[37]toexposeO-ringonthestem.

19. RemoveO-ring[34]fromstem.20. Discardandreplacespring[35].21. Reinsert stem [33]withnewspring intoprimaryoutlet

body [37].ExtrudestemandinstallO-ring[34].22. ReplaceO-ring[32]onoutsideofprimaryoutletassembly.23. Reinstall primary outlet assembly torque to 10 ft-lbs

(13.6 Nm).

[6]

[2]QUANTITY-4

[4]

[5]

[11]

Spanner Wrench(P/N504839)

[32][34]

[33]

[35]

[37]

Primary Outlet Assembly

Figure N24. LubricateproportioningvalveborewithKrytoxGPL106.25. Alignthe(3)holesontheproportioningvalveassembly

[16]equaldistancebetweenthe(2)plugsandpush in.*Referencedrawingbelow.

26. Replace washer [19] and phillips head screw [18].27. Place new resistance ring [17] in its place on the

proportioningvalveassembly.*Proportional valve assembly inserted, with the

“H” stamped on back for High Flow Model.plugs

[16]

[18][19]

[17]

The “H” is stamped on the back for HIGH Flow models

Page 25: HELIO2 Helium-Oxygen Blender - Precision Medical · 2 Blender SECTION 2: TECHNICAL DESCRIPTION The HELIO 2 Blender is a medical device used to mix Medical Heliox and USP Oxygen into

-24-HELIO2 Blender

Step 4: TEST

Equipment Required MedicalHelioxSupplyMedicalOxygenSupply

CalibratedOxygenAnalyzer/MonitorFlowmeter0to120lpmorgreater

CalibratedPressureGauges0to100psiRegulators/Tubing/Hoses

Tools Required Phillips Screwdriver

Torque Driver capable of 10 in-lbsAdjustable WrenchRetainingRingPliers

Nut Driver

Typical Test Configuration Diagram

Compressed Heliox Supply

Adjustable 0-100 psi

(0-6.89 bar)

PressureGauge0-100 psi

(0-6.89 bar)

BlenderPressureGauge

0-100 psi(0-6.89 bar)

OxygenSupply

Adjustable 0-100 psi

(0-6.89 bar)

OxygenAnalyzer

OxygenFlowmeter0-70 lpm

T-Fitting

INSTRUCTIONS FOR TESTINGA. Heliox and Oxygen Supply Setup

Bothgassuppliesmustbecleananddryperthespecificationsoutlinedinthismanualandhavetheabilitytogenerateupto100psi(6.89bar)forboththehelioxandoxygeninletpressures.Verifyhelioxtankconcentrationpriortoconnectinghelioxhosetotank.

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-25-HELIO2 Blender

B. Blender Setup1. MounttheBlenderintoasecuredmatingwallorpolebracketinanuprightposition.2. SecurethehelioxandoxygenhosestothecorrespondingBlenderinlets.3. Attachaoxygenflowmetercapableof0-120lpmtotheauxiliaryoutletonthe

Blender.4. Attachat-fittingtotheoutletoftheflowmeter.5. AttachanOxygenAnalyzer/Monitortotheoneoutletonthet-fitting.6. The system is now ready for an initial performance test.

C. Initial Performance TestNOTE: Beforepressurizing,makesureproportioningvalveassembly issecureand

screwistightened.1.PerformcalibrationonOxygenAnalyzer/Monitorperthemanufacture’sinstructionspriortotestingtheBlender.

2.Sethelioxandoxygenpressuresto50psi(3.45bar)each.NOTE:TurnOFFandcheckforleakbywatchingforpressuredropsonpressure

gauges.AssureBleedFlowValveisnotengaged.3. An initial pressure drop may occur, no further drop in pressure should occur.4.Ifcontinuedpressuredropisobserved,troubleshootbyusingacommercialleakdetectortofindsourceofleakandrefertoSection4:TROUBLESHOOTINGforfurther instructions.

5.UsealintfreedryclothtowipeBlendercleanofcommercialleakdetector.6.Ensurebothinletpressuresareat50psi.7. Replace the top cover.

NOTE: DONOTinstallthefour(4)mountingscrewsuntiltheendoftheFinalTest,oraftersatisfactorycompletionofthePerformanceCheck.Refertothe“OPERATINGINSTRUCTIONS”inUsersManual.

8.Setflowmeterto15lpm.9.Set theBlender to 60%FIO2withOxygenAnalyzer/Monitor, this value should

remainwithin3.0%oforiginalreadingthroughoutthefollowingtest.a.Setflowmeterto30-30.5lpm,checkconcentrationreading.b.Setflowmeterbackto3-3.5lpm.c. Sethelioxinletpressureto50psi(3.45bar)andtheoxygeninletpressureto

43psi(2.96bar)adjustflowto3-3.5lpm,checkconcentrationreading.d.Sethelioxinletpressureto43psi(2.96bar)andtheoxygeninletpressureto

50psi(3.45bar)adjustflowto3-3.5lpm,checkconcentrationreading.e. If theOxygenAnalyzer/Monitor settingdoesnot remainwithin 3.0%of the

originalreading,thenreplaceoneorbothdiaphragmhousingassemblies.

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- 26 -HELIO2 Blender

D. Reverse Gas Flow Procedure(ReferenceOperationalVerificationProcedure#’s2&3inTable,page27or28).

1. AssureBleedFlowValveisnotengaged. Disconnecttheoxygenhosefromthegassource.RemovealloutletconnectionsfromtheBlendertoensurethatthereisnooutletflow.

2. Placethefreeendoftheoxygensupplyhoseunderwater.Graduallyincreasethe heliox supply pressure from 30 -75psi(2.07-5.17bar),checkforleakagepasttheoxygeninletcheckvalve.

3. ReplacetheDuckbillCheckValveintheoxygeninletifleakageis>100ml/min.4. Repeatsteps1-3tocheckforleakagepastthehelioxinletcheckvalve.5. Reconnectthehelioxinlethoseandadjustbothsupplypressuresbackto

standard inlet pressure.

E. Setup of PROPORTIONING VALVE ASSEMBLY1. Sethelioxandoxygeninletpressuresto50psi(3.45bar).2. Setflowto15lpm,measuredwithoxygenflowmeter.3. Turn Adjustment Shaft counterclockwiseuntiltheOxygenAnalyzer/Monitordisplays

a concentration equal to that of the source heliox (±0.3), reference Part A in Setup.4. Attachknobguideassemblyontoadjustmentshaftofproportioningvalveassembly

sothattheknobstoprestsagainstthescrew.Ensureknobstopalignswiththeslotintheresistancering.

5. Whileapplyingdownwardpressuretothetwo(2)screwsontheknobguideassembly,attachnuttoadjustmentshaftusingnutdriver.

6. Turnknobguidefullyclockwise,OxygenAnalyzer/Monitordisplayshouldbeequaltotheconcentrationofsourceoxygen(±0.3).

7. Turnknobguidebackto20or30%positiontoensurenodriftfromoriginalreading(±0.3).

8. Torquenuttoadjustmentshaftandtightento10in-lbsusingatorquedriver.9. Snapinknobbackintoknobguide,paycloseattentiontothekeylocationofthe

knob.10.Setknobto12o’clockposition.11. Replace the top cover. NOTE: DONOTinstallthefour(4)mountingscrewsuntiltheendoftheFinalTest.

F. Final Test CompleteOperationVerificationProcedureasperthetesttable,page27or28. Record test results in the test table. WhenFinalTestiscompletereplacetopcoverandinstallthefour(4)mountingscrews

into cover.

NOTE: OperationVerificationProcedureshouldbeperformedatleastonceayear.

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- 27 -HELIO2 Blender

USAandCANADAONLYHIGH Flow Operation Verification Procedure

(50psi/3.45barMODELS)Serial No.

SEQ#

DIAL SET

Oxygen%

OXYGEN PRESS

±1.0

HELIOXPRESS

±1.0FLOWMETER

SET TOlpm ±0.2

AUXILIARYBLEED FUNCTION TARGET

VALUEACTUALVALUE

psi bar psi bar

1 ANY 50 3.45 50 3.45 closed closed leak <2 psi / 2MIN

*2 60 75 5.17 0 0 0 closed backflow <100ml/min

*3 60 0 0 75 5.17 0 closed backflow <100ml/min

4 20 or 30 50 3.45 50 3.45 15 closed end point (±0.3) Source Value

5 40 50 3.45 50 3.45 15 closed set point 37.0%-43.0%

6 60 50 3.45 50 3.45 15 closed set point 57.0%-63.0%7 80 50 3.45 50 3.45 15 closed set point 77.0%-83.0%

8 100 50 3.45 50 3.45 15 closed end point (±0.3) Source Value

9 60 50 3.45 50 3.45 1.5 open set point 57.0%-63.0%10 60 60 4.14 67 4.62 1.5 open set point 57.0%-63.0%11 60 60 4.14 50 3.45 1.5 open set point 57.0%-63.0%

12 60 50 3.45Slowly reduce to 31

Slowly reduce to2.14

15 closed Alarm ON

31.0± 6.0 psi

13 60 50 3.45

SlowlyIncrease

until alarm shuts off

15 closed Alarm OFF

45.0psiMAX

14 60Slowly

Reduce to 31

Slowly Reduce to2.14

50 3.45 15 closed Alarm ON

31.0± 6.0 psi

15 60

SlowlyIncrease

until alarm shuts off

50 3.45 15 closed Alarm OFF

45.0psiMAX

16 60 50 3.45 50 3.45 MAX closed flowrate 120.0 lpm MIN

17 60 50 3.45 0 MAX closed flowrate 85.0lpmMIN

18 60 0 50 3.45 MAX closed flowrate 85.0lpmMIN

19 60 50 3.45 50 3.45 MAX open flowrate 120.0 lpm MIN

*Reference,LetterD.(ReverseGasFlowProcedure)

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- 28 -HELIO2 Blender

III. INTERNATIONAL LOW / HIGH Flow Operation Verification Procedure (60psi/4.14barMODELS)

Serial No.

SEQ#

DIAL SETOxygen%

OXYGEN PRESS

±1.0

HELIOXPRESS

±1.0

FLOWMETERSET TOlpm ±0.2

AUXILIARYBLEED

FUNCTION

TARGET VALUE ACTUAL

VALUE

psi bar psi bar Low Flow

High Flow

LOWFLOW

HIGHFLOW

Low Flow

High Flow

1 ANY 60 4.14 60 4.14 closed closed leak <2 psi / 2MIN

*2 60 75 5.17 0 0 0 closed backflow <100ml/min

*3 60 0 0 75 5.17 0 closed backflow <100ml/min

4 20 or 30 60 4.14 60 4.14 3 15 open closed end point (±0.3) Source Value

5 40 60 4.14 60 4.14 3 15 open closed set point 37.0%-43.0%

6 60 60 4.14 60 4.14 3 15 open closed set point 57.0%-63.0%

7 80 60 4.14 60 4.14 3 15 open closed set point 77.0%-83.0%

8 100 60 4.14 60 4.14 3 15 open closed end point (±0.3) Source Value

9 60 60 4.14 60 4.14 1 1.5 open set point 57.0%-63.0%

10 60 60 4.14 70 4.83 1 1.5 open set point 57.0%-63.0%

11 60 60 4.14 53 3.65 1 1.5 open set point 57.0%-63.0%

12 60 60 4.14SlowlyLowerto40

SlowlyLowerto 2.76

3 15 closed Alarm ON

42.0±2.0 psi

31.0±6.0 psi

13 60 60 4.14Slowly

Increase to 60

SlowlyIncrease to4.14

3 15 closed Alarm OFF

55.0psiMAX

14 60SlowlyLowerto40

SlowlyLowerto 2.76

60 4.14 3 15 closed Alarm ON

42.0±2.0 psi

31.0±6.0 psi

15 60Slowly

Increase to 60

SlowlyIncrease to4.14

60 4.14 3 15 closed Alarm OFF

55.0psiMAX

16 60 60 4.14 60 4.14 MAX closed flowrate30.0 lpm MIN

120.0lpmMIN

17 60 60 4.14 0 0 MAX closed flowrate30.0 lpm MIN

85.0lpm MIN

18 60 0 0 60 4.14 MAX closed flowrate30.0 lpm MIN

85.0lpm MIN

19 60 60 4.14 60 4.14 MAX open flowrate30.0 lpm MIN

120.0 lpmMIN

*Reference,LetterD.(ReverseGasFlowProcedure)

Page 30: HELIO2 Helium-Oxygen Blender - Precision Medical · 2 Blender SECTION 2: TECHNICAL DESCRIPTION The HELIO 2 Blender is a medical device used to mix Medical Heliox and USP Oxygen into

- 29 -HELIO2 Blender

SECTION 4: TROUBLESHOOTINGTest #’s Problem Probable Cause Remedy

1

Pressure drop greater than 2 psi in two minutes

Leakagefrommanifoldcausedbycutormissingo-ringorduetoparticulates.

CheckALLmanifold connections (inlets, outlets,plugs,proportioningvalve,alarmpoppet,etc.)withoxygenleakdetectortofindsourceofleakage;ifleakis found, remove appropriate parts and clean seal areaando-ringsand/orreplaceappropriateo-ring.

Leakagefromdiaphragmhousingcausedbydamageddiaphragmorparticulates.

Checkdiaphragmhousingswithoxygenleakdetector.Ifleakisfound,disassemblediaphragmhousingassemblyandcleansealareaanddiaphragmand/orreplacediaphragm.

Leakagefromcheckvalve/diaphragmhousingsealcausedbycutormissing o-ringorduetoparticulates.

Check check-valve/diaphragm housing seal withoxygenleakdetector. If leak isfound,removecheckvalve, clean seal area and o-ring and/or replace o-ring.Note: be sure to re-install washer (if present).

Ballnotsealinginthealarmbypass. Replacespringandballinalarmbypass;ensureseal surface is clean.

Auxiliary bleed is open. Closeauxiliarybleedbyturningandpullingknurledcollar away from cover until bleed is closed.

Leakagefromoneoftheoutlets. Replace outlet.

2 and 3 Back flow leak Faulty inlet. Replaceduckbillvalveorentireinletassembly.

4 thru 8

Measured FIO2 values do not meet target values

Outletflowislessthan3lpm. Adjustflowmeterto3lpm(Note:flowmustbeadjustedaftereachchangein FIO2 setting).

Proportioningvalveendpointsarenotsetcorrectly.

Setproportioningvalveendpoints(see setup procedure in Section E).

Diaphragmblocksnotbalancingproperly.

Refurbish diaphragm block assembly with newdiaphragmandcheckvalves.Note: be sure to re-install shimwasherundercheck-valveassembly(ifpresent).

Internalleakageinproportionvalve. Removeproportioningvalve;cleansealareasand/orreplacethetworearo-rings.Ifnecessary,replaceproportioningvalveassembly.

9 thru 11

Measured FIO2 values do not meet target values

Bleed not open. Openbleedbyturningandpushingtheknurledcollar until it contacts the cover.

Blockageinbleedholes. Replace auxiliary outlet.Internalleakinproportioningvalve. Removeproportioningvalve;cleansealareasand/

orreplacethetworearo-rings.Ifnecessary,replaceproportioningvalveassembly.

Flow not set to 1 lpm. Adjustflowto1lpm.Diaphragmblocksnotbalancingproperly. Replacediaphragmblock.

12 and14 Alarm not audible and gas is not exiting the alarm vent

Pressuredifferentialnotsufficienttotriggeralarm.

Ensuresupplypressuresaresetproperlytoachievedifferential (Low Flow:18to22;High Flow:13-25).

Alarm not audible and gas is exiting the alarm vent

Faulty alarm. Replace alarm. (See Figure C & M)

13 and 15 Alarm does not turn off after balancing supply pressures

Faulty alarm assembly. Replace alarm assembly. (See Figure D & K)Ballnotsealinginthealarmbypass. Replacespringandballinalarmbypass;ensure

seal surface is clean.

16 thru 19

Measured flow values do not meet minimum target values

Gasinletsarerestricted. Checkappropriategasinlet(s)forrestrictioningaspathway;replaceduckbillorentireinletasnecessary.

High flow model only:lowflowinletsinstalledinplaceofhigh-flowinlets.

Confirmthathigh-flowinletsareinstalled;replaceas necessary.

Alarm bypass is threaded too far into manifold block(only applicable to tests 17 and 18).

Replaceballandspring(seeFigureIforproperassembly method).

High flow models only:wrongballinalarmbypassblock(only applicable to tests 17 and 18).

Confirmthatcorrectballisinstalledinalarmbypass;replaceasnecessary.

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SECTION 5: BLENDER PARTS LIST LOW FLOW PM5400

HIGH FLOWPM5500PART # DESCRIPTION

1 504562 CONTROLKNOB(DIAL)

2 504720 SCREW,FLTHD,#8-32,1/2LG,100DEG

3 504718 TOPCOVER

4 506090HELIUMINLETASSEMBLY

505989

5 504537OXYGENINLETASSEMBLY

505046

6 504719 BOTTOMCOVER

7 504562 CONTROLKNOB(DIAL)

8 504605 MANIFOLDBLOCK

9504546

PRIMARYOUTLETASSEMBLY

504741

10 504791AUXILIARYOUTLETASSEMBLY

504550

11 504566 AUDIOALARMASSEMBLY

12 504536 RING,RETAINING,HOTYPE,.562BORE,STL

13 504530 ALARMASSEMBLY

14 504702 NUT,HEX,LOCK,#8-32

15 504938GUIDEKNOBASSEMBLY

505030

16 504664setPROPORTIONINGVALVEASSEMBLY

504557set

17 505009 RESISTANCERING

18 504561 SCREW,PANHD,#6-32,1/4LG,CR,SST

19 504684 WASHER,FLAT,.281,.140,.030,SST

20 *505002 DIAPHRAGMHOUSINGASSEMBLY

21 504526 SCREW,HEXSOCHD,#10-32,2.00LG,SST

22 504528 PLUG

23 504553 ALARMBYPASSBODY

24 504870 BALL,.188DIA,BUNA-N,70DUROMETER

25 504519SPRING,ALARMBYPASS

505043

26 504122 O-RING,#008,SILICONE,70DUROMETER

27 504522 DIAPHRAGMHOUSING

28 504525 SCREW,HEXSOCHD,#10-32,3/4LG,SST

29 505004 DIAPHRAGM

30 505003 CHECKVALVE

31 504122 O-RING,#008,SILICONE,70DUROMETER

32 504686 O-RING,#013,SILICONE,70DUROMETER

33 504628STEM,PRIMARYOUTLET

504743

34 1013 O-RING,#006,BUNA-N,70DUROMETER

35 0143 PRIMARYVALVESPRING

36 504997 O-RING,10MMX1.5MM,VITON,75DUROMETER

37 504547PRIMARYOUTLETBODY

504742

38 504705 BLUEMUFFLER,WASHER (NOt SOlD Separately, iNCluDeD iN 504791 & 504550)

N/A 506125/506126 SERVICEKITS-PM5470/PM5480

N/A 506212/506213 SERVICEKITS-PM5570/PM5580

* NOT sold assembled.

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- 31 -HELIO2 Blender

LABEL INFORMATION

Part # Label Description Low Flow PM5400

High FlowPM5500

Location(Blender with dial facing you)

506122Primary Outlet

Left Side on top cover

506019

506008 HELIO2 80-20 LeftandRightSideontopcover

506013 HELIO2 70-30

505961Scale 20-100

Bottom Front on top cover

505960

505974Scale, 30-100

Bottom Front on top cover

505973

506011 Warning TopBackontopcover

506004 Face

Top Front on top cover

506003Auxiliary Outlet

RightSideontopcover

506020

506018 Bottom

BottomCover

506007 PM5580Model#,Serial# BottomBackonrearslidemount

506012 PM5570Model#,Serial#

506026 PM5480Model#,Serial# BottomBackonrearslidemount

506021 PM5470Model#,Serial#

For customized Blenders with special labels, contact Precision Medical, Inc.

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- 32 -HELIO2 Blender

Page 34: HELIO2 Helium-Oxygen Blender - Precision Medical · 2 Blender SECTION 2: TECHNICAL DESCRIPTION The HELIO 2 Blender is a medical device used to mix Medical Heliox and USP Oxygen into

PrecisionMedical,Inc.300 Held Drive

Northampton, PA 18067 USA

TollFreeTel:800-272-7285 TollFreeFax:800-353-1240 Tel:(+001) 610-262-6090 Fax:(+001) 610-262-6080

506124 Rev2 090811 Printed in USA