Vapotherm 2000i Instruction Manual

2000i
Operating Instruction Manual

Section 1 Indications and Contraindications
Primary Indications:
Used to warm and humidify breathing gases, generally prescribed during oxygen therapy where concentrations
of oxygen greater than ambient air are utilized to treat symptoms and manifestations of hypoxia including:
• Documentedhypoxemia:decreasedPa02in blood below normal range
• Acutecareinwhichhypoxemiaissuspected
• Severetrauma
• Acutemyocardialinfarction
Secondary Indications:
• Managinghypothermia
• Treatingbronchospasmcausedbycoldair
Contraindications:
General:
• Anysituationsinwhichhumidificationiscontra-indicated(seeAARCClinicalPracticeGuidelines)
SpecifictoNasalCannula:
• Patientswithoccludedordefectivenaresshouldnotusethesystem.
Section 2 Definitions,WarningsandCautions
2.1 Definitions
AWARNINGindicatesthatapotentiallyharmfulsituationmayoccur.
ACAUTION indicates a condition that may lead to equipment damage, malfunction, or
inaccurateoperation.
ANOTEindicatesapointofemphasistomakeoperationmoreefficientorconvenient.
ASEPTIC TECHNIQUE is practices and procedures performed under carefully controlled conditions with
thegoalofminimizingcontaminationbypathogens.Specificallywithrespiratoryequipment,especially
withreferencetotheVapotherm2000i,thisincludesproperhandwashingandavoidingdirecthand
contactwithconnectionpoints.
Pleasetakethetimetofamiliarizeyourselfwiththedefinitions,warnings,cautionsandnoteslistedinthis
manual.Theycoversafetyconsiderations,specialrequirements,andregulations.
Theuserofthisproductassumessoleresponsibilityforanymalfunctionduetooperationormaintenance
performedbyanyonenottrainedbyVapotherm™stafforofficialtrainingdocumentation.
WhenhandlinganypartoftheVapotherm®2000i,alwaysfollowhospitalinfectioncontrolguidelinesand
StandardPrecautions.Vapothermrecommendsthatusersfollowthedisinfectionprocedurefoundinthis
manual.VapothermalsorecommendsthatusersfollowtheCentersforDiseaseControl(CDC)publications:
Guidelines for Maintenance of In-Use Respiratory Therapy Equipment and Guidelines for Prevention of
Nosocomial Pneumonia.
2.2 General Warnings
• FederalLaw(U.S.)restrictsthesaleofthisdeviceto,orbytheorderofanyphysician.
• Thisisahumidificationdevicegenerallyusedforprovidingcontinuousflowsofbreathinggas.
 TheVapotherm®2000iisnotaventilatorydeviceandshouldnotbeusedaslifesupport.
• Thisdevicewillnotoperatewithoutflow.
Operating Instruction Manual Page 3Operating Instruction Manual Page 2
Contents Page
Section 1 Indications and Contraindications 3
Section 2 Definitions, Warnings and Cautions 3
Section 3 About Vapotherm™2000i Product Description 5
Section 4 General 2000i Set up and instructions
 4.1 SetUp–The2000iUnit 7
 4.2 SetUp–SelectingtheVaporTransferCartridge 7
 4.3 SetUp–InsertingtheVaporTransferCartridge 8
 4:4 SetUp–InsertingthePatientDeliveryTube 8
 4:5 SetUp–VapothermSpikeSet(VSS-1) 9
 4:6 SetUp–ConnecttoaGasSource 9
Section 5 Operations
 5:1 Operations–PrepareforActivatingtheUnit 10
 5:2 Operations–TurnonFlow 10
 5:3 Operations–PrimingtheUnit 10
 5:4 Operations–ActivatetheUnit 10
 5:5 Operations–SettingtheTemperatureandWarm-Up 11
 5:6 Operations–ConnectingtoaPatient 11
 5.7 Operations–GeneralGuidelines 12
Section 6 Alarms and Troubleshooting
 6.1 General 13
 6.2 AlarmandTroubleshootingTable 13–14
 6.3 ComponentChange-outs 15
 6.3.1 ReplacingtheVaporTransferCartridge 15
 6.3.2 ReplacingthePatientDeliveryTube 15
 6.3.3 ReplacingtheVSS-1SpikeSet 15
Section 7 Removing From Patient and System Shut Down 16
Section 8 Routine Disinfection Procedure
 8.1 DisinfectionSupplies 17
 8.2 Pre-cleaningProcess 17
 8.3 Pre-disinfectionCleaningandDecontamination 18
 8.4 Set-up 18–19
 8.5 DisinfectGasandWaterCircuits 20
 8.6 Drying 21
Section 9 Specifications 22
 9.2 Definitionsandsymbols 22
Section 10 Warranty Information 23
Section 11 Reference and Bibliography 24
AppendixA–DisinfectionSolution 25–26
AppendixB–SampleDisinfectionLog 27

Section 2 WarningsandCautions
General Warnings (cont.)
• TheVapotherm®2000imustbedisinfectedbetweeneachpatientuseandafter30daysofuseonthe
samepatient.
• Gasflowdeliveredbythisdeviceislimitedto40litersperminute.Maximumoperationalflowrate
shouldnotbeexceeded.
• PriortousemachineshouldbepositionedandsecuredtoasturdyIVpole.
• Thesystemincludesseveraldisposableelementsthatarelabeledassinglepatientuseonly:donot
attempttosterilizeorreuse.Followalllocalandfederalregulationsfordisposal.
• Oxygensupportscombustion;thisdeviceshouldnotbeusednearoraroundopenflames,oil,grease
oranyflammablesoranesthetics.
• Performanceverificationmustbeperformedpriortouse.
• Serviceonthedeviceshouldbeperformedbyqualified,certifiedservicetechniciansONLY.
• TopreventinjurydonotattempttoperformanyservicetotheVapotherm2000iwhileapatientis
connectedtothedevice.
• Ifthedeviceisdamagedornotworkingproperlydonotuse.ContactVapothermoryourauthorized
Vapothermrepresentative.
• Donotoperateifpowercordisdamaged.
• Thedeviceshouldnotbeturnedonandleftunattended.
• DonotusetheVapotherm2000iinoraroundwaterotherthanthewaterbagthatfeedsthesystem.
• Failuretoutilizesterilewatersupplyorcleangassupplymayincreaseriskofbacterialcontamination.
• TheVapotherm2000iutilizeswarmedwaterandcanposeariskforcolonizationofbacteriaand
patientinfectionifdisinfectionproceduresarenotfollowed.
• GasflowisexternaltotheVapotherm,butthecaregivershouldconfirmtheintegrityofallrespiratory
gasesutilizedtoensuretheyarefreeofcontamination.
• Gassupplymustbemadeofcleandrymedicalgradegastopreventharmtothepatientandprevent
damagetotheVapotherm2000i.
• Anoxygenanalyzerwithalarmsmustbeusedwhenthedeliveredconcentrationleveliscritical.The
Vapotherm2000idoesnotprovideoxygenconcentrationanalysiscapability.
• Toreduceanypotentialtransmissionofcontaminatedwaterfromthesystem,allassemblyand/or
disassemblyoftheunitshouldtakeplaceoutsidetheprimarycareareas.
• The2000iisnotaContinuousPositiveAirwayDevice(CPAP).Therearenocontrolstodeliveror
monitorairwaypressure.The2000ihumidifiesbreathinggasesthataredeliveredexternallythrough
standardair/oxygenblenderandflowmeter.The2000ishouldnotbeusedtodeliverpressureina
closedsystem.
2.3 Cautions
• Verifythatthepowersourceiscompatiblewiththeelectricalspecificationsshownoneachcomponent.
Forpropergroundingreliability,connectthe2000ipowercordonlytoaproperlymarkedhospitalgrade
receptacle.DONOTUSEEXTENSIONCORDS.Ifanydoubtexistsastothegroundingconnection,DONOT
operatethedevice.
• DonotimmersetheVapotherm2000iinwater.DonotsteamorgassterilizetheVapotherm2000i.
• Readandunderstandthismanualpriortooperatingthesystem.
• TheVapotherm2000imustbedisinfectedifthewatercircuitisopenedupbyremovingorreplacinga
component.
• Aseptictechniques(includingproperhandwashingandavoidingdirecthandcontactwithconnection
points)andStandardPrecautionsshouldalwaysbefollowedwhenhandlingmedicalequipment.
• StandardPrecautionsshouldalwaysbefollowedwhencomingincontactwithpatients.
Operating Instruction Manual Page 4
Section 2 WarningsandCautions
2.4 General Inspection
WhenunpackingtheVapotherm2000isystem,ensurethattheunitisinspectedfordamagebeforeuse.
ReportanydamageormissingpartsimmediatelytoyourauthorizedVapothermdistributor.
WhenrentingaVapotherm2000i,customersshouldrequiretherentalservicetoprovideacertification
thatthemachinehasbeendisinfectedbeforeacceptingdelivery.
Section 3 AbouttheVapotherm2000iand2000h
TheVapotherm™2000hforhomeuseconsistsofthecombinationofa2000iunitandthe“HomeCare
CompressorKit(PartnumberHCK200-M)”.TheHCK-200KitconsistsofanHS-100Stand,a5060A
RoomAirCompressorandFlowmeterassembly.
1.AVapothermauthorizedDurableMedicalEquipment(DME)Supplierisresponsibleforthefollowing:
Operating Instruction Manual Page 5
2.Theuser/homecareproviderisresponsibleforthefollowing:
• Assemblingthe2000iunitandthekitcomponents
• Instructing the user in their responsibilities for operating the system
• Providing1000mlsterilewaterbagsasneeded
• Routineservicingofthesystem
• Removing,replacing,anddisposingofthedisposablecomponents(VaporTransferCartridge,
VapothermSpikeSet-1&DeliveryTube)every30days
• Disinfectingofthe2000iuniteverythirtydaysfollowingtheprocedurefoundin
Section8.1–8.6ofthe2000iOperatingInstructionManual
• Changenasalcannulaswhensoiledorexcessivelywetfromsecretions.Disposeofproperly.
• Installing and replacing the sterile water bag
• Avoidliquidspillsonthecomponents
• Donotattemptanyrepairs.IfyouhaveanyproblemswithyourVapotherm2000idevice
notifytheDMEproviderimmediately

Operating Instruction Manual Page 7
Mounting pole
Flowmeter
Air line Oxygen line
Vapotherm
2000i
Delivery tube
Sterile
Water
Bag
Simple, easy
to use touch
control panel
and information
screen.
Vapor transfer
cartridge
Note: System specification
and front panel layout
may vary.
VSS-1
Spike set
Air/Oxygen
Blender
Section 4 Set-up
4.1 The 2000i Unit
1. Thebackofthe2000ihasanIVpoleclampthat
enablesIVpoleattachment.
2. TheunitshouldbemountedonasturdyIVpole
approximately two feet from the top of the
pole to facilitate ease of access and proper
flowfromsterilewatersystem.
3. Ifusinganoxygenblender,mounttheblender
abovetheVapotherm2000iontheIVpole.
4. Connectblenderhosesintobothairand
oxygenwallconnections.
5. PlugVapothermpowercordintoahospital
wallpoweroutlet.
WARNINGS:
Aseptic technique (including proper hand washing
and avoiding direct hand contact with connection
points) should always be followed when setting up
and operating the Vapotherm 2000i.
The medical gas source is external to the Vapotherm
2000i. Always verify the integrity of the medical gas
source and utilize bacterial filters if necessary.
Closed system components (VSS-1, Vapor Transfer
Cartridge and Patient Delivery Tube) should not be
opened in patient care area.
4.2 Selecting the Vapor Transfer
Cartridge
Vapothermprovidesbothahighflowcartridge
(VT01-AS)andalowflowcartridge(VT01-BS).
• Thehighflowcartridge(VT01-AS)shouldbe
used with the pediatric cannula with an
operationalflowrangeof5 – 20litersperminute
(lpm)orwithadultsizedcannulawithan
operationalflowrangeof8– 40lpm.
• Thelowflowcartridge(VT01-BS)shouldbe
used with the neonatal, premature, infant, or
intermediate sized cannula with an operational
flowrangeof1– 8lpm.
WARNINGS:
Do not exceed maximum operational flow rates of 40 lpm
for the high flow cartridge (VT01-AS) and 8 lpm for the low flow cartridge (VT01-BS).
Ensure that the correct cartridge is inserted before operating.
Section 3 AbouttheVapotherm®2000i
TheVapotherm2000iwarmsandhumidifiesflowsofair,oxygenormedicalgasblendsfordeliverytoa
patient,bynasalcannulaorVapothermapprovedinterface.Warmingandhumidificationofbreathinggas
occursinaVaporTransferCartridge,whereairandwaterareseparatedbyamembranepermeableto
watervapor.Themembraneconsistsofmicrotubulesconstructedofpolysulfonematerial.Themembrane
meetsHIMA(HealthIndustryManufacturersAssociation)standardsonfiltersforsterilizingliquidsandhas
beenshowntoeffectivelyexcludebacteriafromcrossingfromthewatercirculationtothegasflow.
ThewarmedhumidifiedgasstreamreachesthepatientviaapatentedtriplelumenPatientDeliveryTube.
Humidifiedgasflowisdeliveredthroughthecenterlumen.Theouterlumenscontainwaterwhichis
warmedviaaninternalheaterandpropelledthroughthesystemviaaninternalpump(See schematic,
fig. 1).Thismaintainsbreathinggastemperatureandminimizescondensation.Thefinalpatientinterface
isaVapothermnasalcannulaorapprovedinterfaceconfiguredtominimizeresistanceandheatloss.
NOTE: The water circuit and gas circuit of the Vapotherm 2000i do not come in contact with each other.
RespiratorygasesaresuppliedtotheVapotherm™2000ifromanexternalgassupply,typicallythrougha
standardwall-mountedflowmeterconnectedtothehospitalmedicalgassupply.Gasflowrateiscontrolled
bytheexternalflowmeterormedicalgasblender.TherearenoflowcontrolsontheVapotherm™2000i.
Connectionsforgasflowandwateraremadeviatherearpanel.AllVapotherm2000icontrolsareonthe
frontpanelofthedevice.
WARNING: Use of patient interfaces not recommended by Vapotherm may cause safety concerns or
affect the performance of the device.
Operating Instruction Manual Page 6
Fig. 1 Simplified System Diagram
Water Reservoir
Pump
Heater
Heated
Delivery
tube
Breathing Gas to Patient
Breathing Gas
Inlet
Vapor
Tr ansfer
Cartridge

Operating Instruction Manual Page 9
Fig. 4
Fig. 5
Fig. 6
Section 4 Set-up
4.5 Vapotherm Spike Set (VSS-1): for
connecting Sterile Water Bag
1. HangasterilewaterbagfromIVPole.
2. ConnectVSS-1tothewaterinletportonbackofunitandmake
sureitlocksintoplace(Fig.5).
3. EnsuretheVSS-1isclampedthenremovespikecap.Wipespike
withdisinfectantwipes,70-90%isopropylalcohol.
4 Firmlyinsertspikeintosterilewaterbagwhileavoidingdirect
handcontactwiththespiketipandwaterbagseptum.
5. LeaveVSS-1spikesetclampeduntilreadytofillunit.
WARNINGS:
The VSS-1 is single patient use item and should be changed with
each patient.
If the VSS-1 is removed from the Vapotherm device for any reason
the Vapotherm 2000i should be disinfected following the routine
disinfection procedure before being returned to service.
CAUTION: Never leave the VSS-1 unclamped when the system is not
running.
NOTE: Removing an empty sterile water container does not constitute
opening the closed system. New sterile water containers can be spiked
using the same VSS-1 without removing the device from service
following the procedure above.
4.6 Connect To A Gas Source
1. Connectasourceofair,oxygenormedicalgasblendertothegas
inletportofVapotherm2000i(Fig. 6).Gasinletconnectionisa
hosebarbthatacceptsfemalefittingonastandard1/4”
(6.35mm)oxygentube.
NOTE: Vapotherm will not operate unless there is gas pressure at gas
inlet. With no flow/pressure sensed, a “System Failure” alarm will
sound.
Operating Instruction Manual Page 8
Fig. 1
Fig. 2
Fig. 3
Section 4 Set-up
4.3 Inserting the Vapor Transfer Cartridge
1. TheVaporTransferCartridge(VT01-ASorVT01-BS)attachesto
theunitbytwowaterandtwoairconnections.
2. Whenfacingtheunit,accessisviaahingedcoveronrightside.
Thecartridgemaybefittedineitherdirection.
3. Datethecartridge.
4. Removeprotectivecapsfromluersideportsofcartridge (Fig. 1).
5. AttachlowerairtubefromVapotherm2000itolowerendof
cartridge.
6. Insertprojectingsideportsintomatchingconnectionsinunit.
Presscartridgefirmlyintoplace(Fig. 2).
7. AttachupperairtubefromVapotherm2000itotopof
cartridge (Fig. 3).Makesuretubingisnotkinked.
8. Closehingedcover.Ifitdoesnotcloseeasily,checkthatcartridge
is pressed fully into place and that air tubes are not interfering
withcover.
WARNINGS:
The cartridge must be changed between patients and discarded
after each use.
If the cartridge is removed, the unit should be disinfected.
If the cartridge is dropped, it should be discarded.
NOTE: Do not remove cartridge from the Vapotherm 2000i
without first draining the machine.
4.4 Inserting the Patient Delivery Tube
1. InsertPatientDeliveryTubeintolowerportionoftheunitby
aligningbluetabsontubewithnotchesonbottomofunit.
2. Firmlypressintoplace(Fig. 4, see next page).Bluelipontube
mustbeflushwiththebottomofunit.
3. Rotate1/4turnclockwiseandpullslightlydownwardstolockinto
place(Fig.4,see next page).
WARNING: The Patient Delivery Tube is a single patient use item
and should be changed with each patient.
If the Patient Delivery Tube is removed from the device for any reason
the Vapotherm 2000i should be disinfected following the routine
disinfection procedure before returning to service.
CAUTION: Unit will not operate correctly if the Patient Delivery Tube
is inserted improperly or not locked into place.

Section 5 OperationofTheVapotherm™2000i
5.5 Setting the Temperature and Warm-Up
1. TheVapotherm2000idisplaystheactualtemperatureofthecirculatingwater.Pressandreleasethe
upordownarrowonthefrontoftheunittodisplaytemperaturesettingfor3seconds.
2. ToadjustthetemperaturesettingoftheVapotherm2000i,pressandholdtheupordownarrow
untilthedesiredtemperatureisdisplayedintheLED.
NOTES:
The Vapotherm 2000i always defaults to previous set temperature at power up.
The temperature can be set between 33 and 43˚C.
5.6 Connecting to Patient
1. WaitfordesiredoperatingtemperaturetobereachedBEFORE placing the cannula on the end of
thePatientDeliveryTube.
2. Checkwaterlevel,temperaturedisplayandgasflowrate.
3. Sizecannulatopatientbyensuringthatnasalprongsdonotfittightlyintonares.
4. Attachproperlysizedcannulathatisdesignedtofunctionwiththecartridgeinstalledinthemachine
ontothedeliverytube.Adjusttheflowtothedesiredrateandplacethecannulaonthepatient.
5. Somecondensationofmoisturearoundnoseispossible.Inaddition,highmoisturelevelmay
mobilizemucusfromnoseandsinuses.Makesurepatienthasasupplyoftissues.
Cartridge Cannula Type Operational Flow Rates
High Flow (VT01-AS) Adult 8 – 40 lpm
High Flow (VT01-AS) Pediatric 5 – 20 lpm
Low Flow (VT01-BS) Premature, neonatal, infant, intermediate 1 – 8 lpm
WARNINGS:
Always follow aseptic technique (including proper hand washing and avoiding direct hand contact with
connection points) when setting up the Vapotherm 2000i and Standard Precautions when placing on
a patient.
Cannula should not obstruct the nares of the patient.
Change nasal cannulas when soiled.
After start-up, during the normal purging of the Patient Delivery Tube, air will release and appear as
bubbles in the bubble trap of the VSS-1. If the Patient Delivery Tube is filled and a stream of continuous
bubbles appear in the bubble trap, it may indicate a problem with the cartridge or Patient Delivery Tube
and both should be checked or changed.
NOTE:
If using a low flow cartridge (VT01-BS) the flow cannot be decreased below 5 lpm until an appropriate
cannula has been attached to the delivery tube
Droplets of condensation may appear at the end of Patient Delivery Tube while unit is warming up. This
is normal and will stop within a few minutes when temperature is reached. If this condition continues
refer to trouble shooting section. If the system operates while not connected to a patient, condensation
is likely to develop.
Operating Instruction Manual Page 11
Operating Instruction Manual Page 10
S
C
Mute
Powe
r
Fig. 2
Fig. 3
Section 5 OperationofTheVapotherm™2000i
5.1 Prepare for Activating the Unit
1. EnsurethattheVapotherm2000ipowercordispluggedintoa
hospitalelectricalwalloutlet.
2. UnclamptheVapothermSpikeSet(VSS-1)(Fig. 1).
5.2 Turn on Flow
1. Ifusingthehighflowcartridge(VT01-AS)flowshouldbe
startedatleast8lpmforwarm-up.
2. Ifusingthelowflowcartridge(VT01-BS)flowshouldbeset
toatleast5lpmforwarm-up.
3. Turnonflow.
5.3 Priming the Unit
1. UnitshouldbestartedinCLEANINGMODE“CL”toprimeanew
PatientDeliveryTube.
2 ToplaceunitinCLEANINGMODE,pressboththepoweronand
theALARMSILENCE/MUTEbuttonssimultaneously(Fig. 2).
3. Thedisplaywillshow“CL”andLEDnexttocleaningicon
S
willilluminate.
4. WaterwillbegintocirculateandfillthePatientDeliveryTube.
5. OperateinCLEANINGMODEuntilPatientDeliveryTubehasbeen
purgedofairbubbles.
6. Whenairhasbeenpurged,pressPOWERtostopsystem
7. Waituntildisplayblanks.
NOTES:
Pressing both the power and alarm mute buttons will set unit
in CLEANING MODE, pressing only the power button sets unit in
NORMAL mode.
Water is not being heated in CLEANING MODE: the purpose
of this mode is to fill the outer lumens of the Patient Delivery Tube
with water.
Gas flow is highly recommended (but not mandatory) during priming.
5.4 Activate the Unit
1. PressthePowerbuttononly,tostartinNORMALMODE(Fig. 3).
2. IfnotusingthePatientDeliveryTubewithintegratedcannula,
donotplacecannulaontheendoftubeuntilwarmupiscomplete.
Fig. 1

Operating Instruction Manual Page 13
Alarm Cause Action
indication
NOTE: To restart after a system failure, the unit must be reset by a momentary pressure on the Power
button. Do not hold the Power button. The alarm will shut off after a delay of about a second, and
the unit can then be restarted normally.
S
S
Waterisnotfillingsystemproperly
LowWaterPressure
MalfunctioningWaterorGas
PressureSensor
MakesureVSS-1spikesetisopen,and
the tube is not kinked or blocked by
airbubbles.
Make sure gas and water connections are
open, gas can flow to unit, and air has
purged from water system: if not, run
‘CLEANINGMODE’.
Sendinforservice.
Water low
Insufficientgasorwaterpressure.
Malfunctioning WaterorGas
PressureSensor
Make sure the gas and water circuits are
open and functional and air has purged
from the water circuit if the unit is in
normaloperatingmode.
Runin“CLEANINGMODE”.
Make sure there is correct flow for
cartridgeflowrates.Ifusing<5lpmwitha
low flow cartridge, a nasal cannula must
beattached.
If a component failure return the unit
forservice.
System Failure
Cartridge Waterdropsinthecircuitwill
causeacartridgealarm;thisdoes
not necessarily mean the cartridge
needstobereplaced.
Section 6Alarms,TroubleShootingandComponentChange-Outs
6.1 General
1. Periodicallycheckforalarmconditions.
2. Unitwillshutdownifthereisnogasflow.However,flowwillnotbeinterruptedifunit
shutsdownormalfunctionsforanyotherreason.
3 Unitwillshutdowniftemperaturesafetylimitsareexceeded,orifwaterlevelislowfor
morethan4mins.However,unheatedgasflowwillcontinue.
NOTE: Should a malfunction occur, indicators on the front panel will light and an alarm will sound.
If the actions listed here do not correct the problem causing the alarm, the unit should be returned to
an approved facility for service.
6.2 Alarms and Troubleshooting
Section 5 OperationofTheVapotherm™2000i
5.7 Operations – General Guidelines
1. CheckthatwaterisproperlycirculatingthroughthemachinebymakingsurethePatientDelivery
Tubeiswarmacrosstheentirelength.
2. Ifgoodcirculationcannotbeconfirmed,checkthatthewaterflowisnotobstructedbyairbubbles.
3. Takeprecautionstominimizecoolingoftheunheatedcannulabytryingtomaintaincontactwith
thepatient’sskinandinsulatingtheexposedportionofthecannulawithbedding.
4. Cartridgedoorshouldbeclosedduringoperation.
NOTE: Condensation in the cannula may occur at low flow rates. To minimize condensation, these
general guidelines should be followed:
• If using flow rates less than 5 lpm, do not set the temperature higher than 34ºC.
• TheVapothermunitshouldnotbeinapositionwhereitiscooled(eg.byanairconditioningoutlet).
CAUTION: DO NOT EXCEED flows of 8 lpm for VT01-BS and 40 lpm for VT01-AS cartridge.
DO NOT SET flows below 1 lpm for VT01-BS.
WARNING:
Never occlude the nares with cannula.
NOTES:
It may become necessary to disconnect the cannula from the Patient Delivery Tube for short periods, such as
when moving a patient out of a radiant warmer. At flow rates less than 5 lpm, cannula disconnection will
activate a system failure alarm, requiring a reset. To avoid this alarm, briefly turn off unit by pressing the power
key once. The display will show two bars. Disconnect the cannula from Patient Delivery Tube and move the
patient, reconnect the cannula, then press the power key once more to restart the unit.
A SYSTEM FAIL (88) alarm will activate if there is insufficient gas pressure in the manifold. If no cannula is fitted,
flow rate at startup should be at least 5 lpm. The minimum flow rate for operation is 1 lpm if a neonate, infant
or premature-sized cannula is fitted, 5 lpm with a pediatric cannula, and 8 lpm with an adult cannula.
Cannulas are single use patient items, dispose of as necessary or according to your institution’s guidelines or
when visibily soiled or excessively wet from secretions. Weekly change out is recommended to avoid any
hardening of nasal prongs.
An air lock can develop at the pump, preventing normal water flow. Try restarting the unit in
cleaning mode.
Operating Instruction Manual Page 12

Operating Instruction Manual Page 15
Fig. 1
Fig. 3
Section 6Alarms,TroubleShootingandComponentChange-Outs
6.3 Component Change Outs
WARNINGS:
The vapor transfer cartridge, patient delivery tube, and VSS-1
spike set are all single use only and should be discarded after
removal from the Vapotherm 2000i.
The Patient Delivery Tube, VSS-1 and Vapor Transfer Cartridge
should not be changed or replaced in the patient care area.
The system must be disinfected any time the Vapor Transfer
Cartridge, VSS-1 or Patient Delivery Tube are removed.
NOTE: The cannula and sterile water source can be replaced without
disinfecting the system. As with all respiratory equipment, proper
hand washing techniques should be followed before contacting
or replacing any patient interfaces.
6.3.1 Replacing Vapor Transfer Cartridge
1. Poweroffunit.Disconnectgasflow.
2. ClosecliponVSS-1.(Fig. 1)
3. Openhingedcover.
4. Disconnectairtubesfromcartridgeendsbypressingtubingaway
fromcartridge.
5. Removecartridgebypullingstraightoutwards.(Fig. 2)
6. ProceedtoSection8.0anddisinfecttheVapotherm®2000idevice
beforereturningthedevicetoservice.
7. Forset-uppleaserefertoSection4.3ofthemanual.
CAUTION: Do not grip cartridge tubing with sharp instruments.
6.3.2 Replacing the Patient Delivery Tube
1. Powerunitoff.Disconnectgasflow.
2. Toremovetube,pushbaseoftubeupwards,rotate1/4turn
counterclockwiseandpulldownward.(Fig. 3)
3. ProceedtoSection8.0anddisinfecttheVapotherm®2000idevice
beforereturningthedevicetoservice.
4. Forset-uppleaserefertoSection4.4ofthemanual.
6.3.3 Replacing the VSS-1 Spike Set
1. Poweroffunit.Disconnectgasflow.
2. ClampVSS-1andremoveVSS-1SpikeSetfromthewaterinlet
portonthebackoftheVapotherm2000ibyreleasingthe
quickconnectonthewaterinletport.
3. ProceedtoSection8.0anddisinfecttheVapotherm®2000idevice
beforereturningthedevicetoservice.
4. Forset-uppleaserefertoSection4.5ofthemanual.
Fig. 2
Alarm Cause Action
indication
Operating Instruction Manual Page 14
If further assistance is needed please call your clinical product specialist or local distributor representative.
S
S
IftheCartridgeAlarmiscontinuous
and air bubbles are rising into the
VSS-1bubbletraporifaflowor
waterisvisibleinthetubebelow
the cartridge, then the cartridge
hasfailed.
If cartridge alarm is intermittent
and there are no bubbles in the
VSS-1bubbletrapornoobvious
water flow below the cartridge there
maybecondensationinthesystem.
Firstdisconnectthepatientfromtheunit,
shut down unit, drain unit, disinfect unit,
replacecartridge,VSS-1anddeliverytube,
andfollowsetupinstructions.
Occasional brief alarms due to
condensationarenotacauseforconcern.
Trybrieflypinchingandreleasingtube
undercartridgetodislodgethedropsand/
ordecreasesettemperature.
Cartridge
MalfunctionofTemperature
ControlSystem.
Shutdownsystemandreturnforservice.
NOTE: A momentary High Temperature
alarm may occur when the unit has
been switched off and on again. If the
temperature then stabilizes, no action
is needed.
High
Temperature
Alarm
Highwaterorairpressuredueto
high resistance in water circulation
or air outlet: or malfunctioning
pressuresensor.
Blockedtubealarmduetohigh
WATERpressurewillcausea
continuous or intermittent tone
andalarmlight.Theflowof
breathing gas continues, but is
nolongerheated.
Blockedtubealarmduetohigh
GASpressurewillcausea5second
alarmtone.Iftheobstruction
persists the system will continue
toalarmin5secepisodes.Water
circulation continues but the heater
shutsoff.
Checkthatdeliverytubeiscorrectly
positioned, rotated clockwise, and pulled
intolockedposition.Checkthatwateris
circulatingwithindeliverytube.Ifalarm
persistsreplacedeliverytubeand/or
cartridge.Disinfectunitpriortoreplacing
components.
Findandcorrectthecauseofobstruction.
Themostcommoncauseisakinkinthe
nasalcannualorintheprong.Attempting
toruntheVapotherm2000iatveryhigh
flow through a patient interface not
approvedbyVapothermmayalsoraisethe
internal pressure sufficiently to trigger a
BlockedTubeAlarm.
Blocked Tube
Alarm
S
Section 6Alarms,TroubleShootingandComponentChange-Outs

Operating Instruction Manual Page 17
Fig. 1
Section 8RoutineDisinfectingProtocol
8.1 Disinfection Supplies
1. DK-301(a-eincludedinkit) a. DisinfectionBagA b. DisinfectionBagB
 c. DisinfectionTube d. CartridgeBypassTubes
 e. Y-SpikeAssembly
2. Gloves
3. SafetyGlasses
4. Disinfectantwipes,70-90%isopropylalcohol
5. ApprovedDisinfectant
6. 1000mlSterileWaterBag
7. MedicalGradeAirSource
8. Standardadultflowmeterwithoxygen7fttubingattached
WARNINGS:
Vapotherm should be disinfected after each patient or every 30 days on a single patient. Do not disinfect in
an open patient care area.
The DK-301 disinfection kit is a single use item. Operators should open a new disinfection kit for each
disinfection procedure and discard the components at the end of the procedure.
Disinfection Procedure should be performed in a well ventilated area. Use Standard Precautions and
aseptic techniques during this procedure.
The Vapor Transfer Cartridge SHOULD NOT be in place when disinfecting the unit.
The Vapor Transfer Cartridge is a single use disposable and must be discarded after each patient use.
DK-301 IS NOT designed to disinfect Vapor Transfer Cartridges.
8.2 Pre-Cleaning Process
1. Afterpatientuse,itisrecommendedthattheVapotherm2000iSystemremainattachedtotheIV
polewithallthecomponentpartsintact.
2. MovetheVapotherm2000iSystemtoahospitalapproved
reprocessingareaoutsidethepatientcarearea.
WARNING: The water circuit of the Vapotherm 2000i System is not
sterile and can potentially have bacterial contamination. The water
circuit of the device should never be opened in a patient care area.
Transport the Vapotherm 2000i System to an appropriate area for
draining, cleaning and disinfection.
3. Washhandsandputongloves.
4. DraintheVapotherm2000iSysteminareceptaclebycuttingthe
deliverytube.(Fig. 1)
5. Removeanddisposeofthedeliverytube,cannula,VSS-1spike
set,andsterilewatersource.
6. Removeanddisposeofthevaportransfercartridge.
WARNING: The water circuit of the Vapotherm 2000i system has the potential for bacterial growth so
standard precautions should be used to open the water circuit. Disposable components should be disposed of
in accordance with hospital guidelines and operators should wash their hands after breaking down the device.
Operating Instruction Manual Page 16
Fig. 1
Fig. 2
Section 7RemovingFromPatientandSystemShutDown
1. Removecannulaorotherinterfacefrompatient.
2. Pressandreleasepowerswitch(Fig. 1).Displaywillshow“--”
3. ClosecliponVSS-1(Fig. 2).
NOTE: The system’s pump continues to run for 1 minute to allow
heater to cool down.
4. After1minute,waterpumpshutsoffandnumericdisplayis
blank.Unitmaynowbedisconnectedfrompoweroutlet.
5. Removeunitfrompatientcareareaandproceedtodisinfection
process.
CAUTIONS:
Avoid disconnecting from power or gas sources while machine is
operating.
Do not unplug from power source until display is blank.

Section 8RoutineDisinfectingProtocol
8.4 Set-up (cont.)
6. HangBagAwith200mlofapproveddisinfectingsolutionfromIV
polehook.
7. Wipeblueendofdisinfectiontubewithanapproveddisinfectant
wipe.InsertintobottomportofVapotherm™2000isystem.Press
firmlyintoplace,rotate1/4turnclockwise,andpulldownslightly
tolockinposition.(Fig. 5)
8. Wipetheotherendofthedisinfectiontubewithanapproved
disinfectionwipeandattachittothebottomoutletofBagA.
Lockintoplace.(Fig. 6)
9. SuspendBagBonaseparatehookonIVpole.Capshouldbe
firmlyclosedtominimizepotentialspilling.
10. AttachY-SpikeAssemblyby:
a. DisinfectwipemalecolderfittingendofY-SpikeAssembly
and insert it into water inlet port on the back of the
Vapotherm2000isystem.Lockintoplace.(Fig. 7)
b. DisinfectwipetheO2bushing connector end of the
Y-SpikeAssembly.Attachconnectortotheairinletconnector
portonthebackoftheVapotherm2000isystem. (Fig. 8)
c. DisinfectwipethespikeendoftheY-SpikeAssemblyandinsert
intobottomoutletofBagBuntilitcomestoastop.
WARNING: If spike is not properly inserted, it may cause disinfectant
to leak creating a potential safety risk. The spike should be inserted
into Bag B up to the ridge at the bottom of the spike. Do not insert
the spike past the ridge at the
bottom of the spike.
NOTE: If the spike is inserted too
far into Bag B it will be difficult to
remove, do not insert the spike
past the ridge at the bottom of
the spike. If the spike is hard to
remove from Bag B rotate the
spike while removing it to make
it easier.
Operating Instruction Manual Page 19
Fig. 5
Fig. 8Fig. 7
Fig. 6
Operating Instruction Manual Page 18
Fig. 2
Fig. 3
Fig. 4 Tube B
Section 8 RoutineDisinfectingProtocol
8.3 Pre-Disinfection Cleaning and Decontamination
1. Washhandsandputonnewgloves.
WARNING: Always use standard precautions when cleaning and
disinfecting the Vapotherm 2000i system.
Always use individually wrapped 70-90% isopropyl alcohol disinfectant
wipes when wiping down the Vapotherm 2000i and disinfection kit
components.
Always use a new disinfectant wipe taken directly from the package or
container and ensure that the disinfectant wipe has not dried out
before using it on the Vapotherm 2000i device.
2. Wipeexteriorcasingincludinginsidehingedcoverwithan
approveddisinfectantwipe.(Fig. 2)
3. Wipeinsideandoutsideofthefollowingconnectionswithan
approveddisinfectantwipe:
a. Fourcartridgeconnectionportsinsidehingedcover
(Upperandlowercartridgeairtubesandthewater
connectionports)
b. Waterinletandairinletconnectorsonrearofunit
c. Deliverytubeportonthebottomofunit.
8.4 Set-up
1. Takethe4inchbypasstubewith90°barbfittings(BypassTubeA)
andwipetheendswithanapproveddisinfectantwipe.Pressfirmly
intotheinnercartridgeconnectionports(watercircuit).(Fig. 3)
2. Takethe6inchbypasstubewithstraightbarbfittings(BypassTube
B)andwipetheendswithanapproveddisinfectantwipe.Insert
firmlyintoouterupperandlowercartridgeports(aircircuit).(Fig. 4)
WARNING: The By-pass Tubing has been designed to optimize the
flow of solutions through the Vapotherm 2000i system. Failure to use
the By-Pass Tubing supplied by Vapotherm™, Inc. could lead to
improper disinfection and or drying.
3. Closehingedcover.
4. Prepare200mlofapproveddisinfectantsolutionandadditto
BagAwithslideclampclosed(seeAppendixA–“Disinfection
Solutions”forapproveddisinfectionsolutions,appropriate
concentrations,andrequiredholdtimes).
WARNINGS:
Disinfection solutions, concentrations and hold times in Appendix A
have been verified by independent laboratory testing to adequately
disinfect the Vapotherm™2000i machine when following these
instructions. Modifying this procedure or using an alternative disinfection solution, concentration, or hold
time could result in inadequate disinfection thereby increasing the risk of contamination.
Always wear gloves when handling disinfectant solutions, work in a well ventilated area, and use an
accurate measuring device to ensure the proper concentration of disinfection solution and water.