Atmos S 201 Thorax User manual

E349855
0124
GA1GB.710201.0
2021-10 Index: 42
Operating Instructions
ATMOS S 201 Thorax
English
These operating instructions are valid from software version 3.0.53

2
Table of contents
1.0 Introduction.....................................................4
1.1 Notes on operating instructions ...................................... 4
1.2 Intended use ...................................................... 5
1.2.1 Intended use ATMOS S 201 Thorax.................................... 5
1.2.2 Intendedusesecretioncanister2l ................................... 6
1.2.3 Intended use hose system ........................................... 7
1.3 Function .......................................................... 9
1.4 Transport and storage ............................................. 10
1.5 Explanationofpicturesandsymbols ................................. 10
2.0 For your safety .................................................14
2.1 Generalsafetyinstructions ......................................... 14
2.2 Dangerforusers,patients,andthirdparties .......................... 14
2.3 Avoiding damage to the device...................................... 17
2.3.1 Generalinformation ............................................... 18
3.0 Setting up and starting up .......................................20
3.1 Scopeofdelivery .................................................. 20
3.2 Device overview................................................... 20
3.3 Start up .......................................................... 22
3.3.1 Battery charging. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
3.3.2 Secretion canister ................................................. 23
3.3.3 Connecting the hose system ........................................ 26
4.0 Operation ......................................................27
4.1 Explanationofthedisplay .......................................... 27
4.2 Buttonsanddisplaysymbols ....................................... 28
4.2.1 Buttons .......................................................... 28
4.2.2 Displaysymbols ................................................... 29
4.3 Explanationofthedisplayinkeylockmodes .......................... 29
4.3.1 Keylockmodewithbubbles ........................................ 29
4.3.2 Keylockmodewithbarchart ....................................... 29
4.4 Switching on...................................................... 30
4.5 Leakagetest ...................................................... 30
4.6 Function ......................................................... 32
4.6.1 Target vacuum .................................................... 32
4.6.2 Gravity drainage mode ............................................. 32
4.6.3 Suction .......................................................... 33
4.7 Keylock.......................................................... 34
4.8 Therapy process .................................................. 35
4.8.1 Shorttimedisplay ................................................. 35
4.8.2 Longtimedisplay. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
4.8.3 Transferoftherapydata............................................ 37
4.8.4 Reading out the therapy data ....................................... 38
4.9 User settings ..................................................... 39
4.10 Switchingothedevice ............................................ 42
5.0 Warning messages ..............................................43
6.0 Function .......................................................46
6.1 Hose rinsing ...................................................... 46
6.2 Gravitydrainagemodewhileusingthedrainagesystem ................ 46
6.3 Operationofthesecretioncanisterfortemporarygravitydrainage ...... 46
7.0 Accessories, consumables and spare parts.........................48
7.1 Attachmentoftheuniversalbracket(Accessories) ..................... 49
7.2 Attaching the carrying strap ........................................ 49

8.0 Cleaning and care ...............................................50
8.1 Generalinformationoncleaninganddisinfection...................... 50
8.3 Cleaningthedevicesurface......................................... 51
8.4 Recommendeddisinfectants........................................ 51
8.5 Hygieneplan ..................................................... 52
9.0 Maintenance and service ........................................53
9.1 Basic instructions ................................................. 53
9.2 Repairs .......................................................... 53
9.3 Sending in the device .............................................. 53
9.4 Handlingofbatteries .............................................. 53
9.5 Changingthefuse ................................................. 54
10.0 Troubleshooting ................................................55
11.0 Technical data ..................................................57
11.1 Bacterialandvirallter ............................................ 58
12.0 Disposal .......................................................59
13.0 Notes on EMC (Electromagnetic compatibility) .....................60
13.1 Guidanceandmanufacturer’sdeclaration–ambientconditions ......... 60
13.2 Guidanceandmanufacturer’sdeclaration–keyfeatures................ 60
13.3 Guidanceandmanufacturer’sdeclaration–warnings .................. 60

4
§
1.0 Introduction
1.1 Notes on operating instructions
Theseoperatinginstructionsarevalidfromsoftwareversion
3.0.53.
These operating instructions contain important notes on
howtooperatetheATMOSS201Thoraxsafely,correctlyand
eectively.Theirreadinghelpstoavoidrisks,andalsoto
reducerepaircostsanddown-times.Thisincreases,among
otherthings,thereliabilityandservicelifeofthedevice.
Theseoperatinginstructionsservenotonlyfornewoperating
personneltobeinstructedinitsuse,butalsoforuseasa
referencemanual.Thisdocumentmayonlybereprinted,either
inpartorinwhole,withwrittenpermissionfromATMOS.
These operating instructions must always be kept
available near the device.
Careandperiodictestsinconjunctionwithprofessional
executionprovideforoperationalsafetyandreadinessforuse
ofyourATMOSS201Thoraxandarethereforeamustbesides
regularcleaning.
Maintenance,repairs,andperiodictestsmayonlybecarried
outbypersonswhohavetheappropriatetechnicalknowledge
andwhoarefamiliarwiththeproduct.Thepersoninquestion
mustpossessthenecessarytestdevicesandoriginalspare
partsrequiredtocarryoutthesemeasures.
• ThisdevicebearstheCEmarkingCE0124inaccordancewith
theEuropeanMedicalDeviceRegulation(MDR)2017/745.
• TheproductATMOSS201Thoraxcomplieswithallapplicable
requirementsofthedirective2011/65/ECrestrictingtheuse
ofcertainhazardoussubstancesinelectricalandelectronic
equipment(“RoHS”).
• TheDeclarationsofConformityandourGeneralTermsand
Conditionscanbeviewedonourwebsiteatwww.atmosmed.
com.
• ThequalitymanagementsystemappliedatATMOShasbeen
certiedaccordingtointernationalstandardsENISO13485.
• Priortostartinguppleaseperusechapter“2.0Foryour
safety”onpage14inordertobepreparedforanypossible
dangerous situations.

5
1.2 Intended use
1.2.1 Intended use ATMOS S 201 Thorax
Name: ATMOS S 201 Thorax
Main function: TheATMOSS201Thoraxisadeviceformobile,digital
cardiothoracic drainage. The system generates a
controlledvacuumclosetothepatientandhasan
electronicmonitoringsystemwhichshowstheactual
vacuummeasuredatthepatient'ssideandtheairleak.
Theobjectivetherapydataisdisplayedinrealtimeand
illustratedincolourinagraph.Errorsareautomatically
indicatedbyvisualandacousticwarningmessages.
Intended use / intended
purpose:
Restoringthe(natural)vacuuminthepleuralcavityby
drainingoairandsecretion.
Intended users / user prole: • Trained doctors
• Trainedhealthcareprofessionals
Users must not be hard of hearing or deaf and must have
adequate vision.
Intended patient population: Patientsofallageswithandwithoutrestrictions.
Medical condition to be
diagnosed, treated or
monitored:
Accumulatedairanduidsinthethorax(pleuralcavity,
mediastinum,pericardium)thatrequirecontrolled
drainage,monitoring,andbalancing.
Application organ: Thorax(pleuralcavity,mediastinum,pericardium)
Application time: Short-termuseonthepatient(<30days).
Application site: Theapplicationsiteistheclinicalenvironment.The
cardiothoracicdrainagesystemmayonlybeappliedby
healthcareprofessionals.Thedeviceisappliedunsterile.
Thesecretioncanisterandthehosesystemaresterileand
disposable;theycanbeusedinthesterileOTarea.
Patient selection criteria: Patientswhorequireacardiothoracicdrainage(pleura,
mediastinalorpericardialdrainage).
Indications: • Aftersurgicalopeningofthethorax(especiallyafter
cardiacsurgery)
• Pneumothorax
• Pleuraleusion
• Hemothorax
• Pleuralempyema
• Chylothorax
• Othersimilarclinicalpictures
Medical contraindications: • Notsuitableforcardiothoracicdrainagetherapyin
whichnovacuumshouldbeappliedtothepatient.
Other contraindications: • Noseparateuseofthesecretioncanisterandthehose
system(i.e.,withoutthedevice)forshort-orlong-term
gravitydrainage(morethan60minutes).
• Noapplicationunderemergencyconditions.
• Shouldnotbeusedinthehomecaresectorwhichisnot
supervisedbyhealthcareprofessionals.
• Nodrainageofammable,corrosiveorexplosiveuids/
gases.

6
Warnings: Thefollowingcomplicationsmayoccurduringa
cardiothoracic drainage:
• Painduetoirritationoftheintercostalnerves
• Injuriestothelungparenchyma/airleak
• Re-expansion edema
• Eusionretention
• Tension pneumothorax
• Skin/softtissueemphysema
The product is: Active
Sterility / specic microbial
condition:
• Notrequiredforthedevice.
• Secretioncanisterandhosesystemaresterile.
Single-use product /
reprocessing:
• Optionsforreprocessingthedeviceaccordingtothe
operating instructions.
• Secretioncanisterandhosesystemaredisposable.
Fordetailedinformationonthesecretioncanisterandhosesystem,pleaserefertothe
separate intended uses.
1.2.2 Intended use secretion canister 2l
Name: Secretioncanister2l
Main function: Thesecretioncanistertransfersthecontrolledvacuum
generatedbytheATMOSS201Thorax.Fluidsandairare
drainedthroughthesecretionhoseandcollectedinthe
secretioncanister.Theamountofuidinthesecretion
canistercanbereadanddocumentedonthebalancing
scales.Anintegratedbacterialandvirallterprotectsthe
devicefrompossiblecontaminationandfromoversuction.
Intheeventofexcesspressurethepop-ovalveopens
immediately.
Anoptionalwaterlockisusedtovisualizetheairleakon
thepatient'ssidebytheappearanceofairbubbles.
Covercapsareusedforpropersealinganddisposal.
Intended use / intended
purpose:
Collectionofuidsandairfromthethorax.
Balancingtheamountofuid
Optionalvisualizationoftheairleakbytheappearanceof
airbubbles.
Thewaterlockisusedasaone-wayvalvewhenusingthe
secretioncanisterandhosesystem(i.e.withoutadevice)
fortemporarygravitydrainage.
Intended users / user prole: • Trained doctors
• Trainedhealthcareprofessionals
Users must not be hard of hearing or deaf and must have
adequate vision.
Intended patient population: Patientsofallageswithandwithoutrestrictions.
Medical condition to be
diagnosed, treated or
monitored:
Accumulatedairanduidsinthethorax(pleuralcavity,
mediastinum,pericardium)thatrequirecontrolled
drainage,monitoring,andbalancing.
Application organ: Thorax(pleuralcavity.mediastinum,pericardium).

7
Application time: • Secretion canister on the device: For short-term use on
thepatient(<30days).
• Secretioncanisterforgravitydrainage:Fortemporary
useonthepatient(<60minutes).
Application site: Theapplicationsiteistheclinicalenvironment.The
cardiothoracicdrainagesystemmayonlybeappliedby
healthcareprofessionals.Thesecretioncanisterandthe
hosesystemaresterileanddisposable;theycanbeused
inthesterileOTarea.
Patient selection criteria: Patientswhorequireacardiothoracicdrainage(pleura,
mediastinalorpericardialdrainage).
Indications: • Aftersurgicalopeningsofthethorax
• Pneumothorax
• Pleuraleusion
• Hemothorax
• Pleuralempyema
• Chylothorax
• Othersimilarclinicalpictures
Medical contraindications: • Notsuitableforcardiothoracicdrainagetherapyin
whichnovacuumshouldbeappliedtothepatient.
Other contraindications: • Do not use with cardiothoracic drainage systems other
than the ATMOS S 201 Thorax.
• Noseparateuseofthesecretioncanisterandthehose
system(i.e.,withoutthedevice)forshort-orlong-term
gravitydrainage(morethan60minutes).
• Noapplicationunderemergencyconditions.
• Shouldnotbeusedinthehomecaresectorwhichisnot
supervisedbyhealthcareprofessionals.
• Nosuctionofammable,corrosiveorexplosiveuids/
gases.
Warnings: Thefollowingcomplicationsmayoccurduringa
cardiothoracic drainage:
• Painduetoirritationoftheintercostalnerves
• Injuriestothelungparenchyma/airleak
• Re-expansion edema
• Eusionretention
• Tension pneumothorax
• Skin/softtissueemphysema
The product is: not active
Sterility / specic microbial
condition:
Secretioncanisterissterile.
Single-use product /
reprocessing:
Secretioncanisterisdisposable.
1.2.3 Intended use hose system
Name: Hose system

8
Main function: Thedoublelumenhosesystemtransfersthecontrolled
vacuumgeneratedbythedevice.Thesecretionhose
drainsuidsandairintothesecretioncanister.The
measuringandrinsinghosemeasuresandregulatesthe
vacuumappliedonthepatient'sside.Abacterialandviral
lteronthemeasuringandrinsinghoseprotectsagainst
contaminationwithbacteriaandviruses.Atdenedtime
intervals,avalveopensinordertodirectairthroughthe
measuring and rinsing hose into the secretion hose and
torinseliquids,coagulumandotherblockagesintothe
secretion canister.
Chesttubesonthepatient'ssideareconnectedtothe
hose system via the port.
Intended use / intended
purpose:
Transportofuidsandairfromthethorax.
Measurementandregulationofthevacuumonthe
patient's side.
Intended users / user prole: • Trained doctors
• Trainedhealthcareprofessionals
Users must not be hard of hearing or deaf and must have
adequate vision.
Intended patient population: Patientsofallageswithandwithoutrestrictions.
Medical condition to be
diagnosed, treated or
monitored:
Accumulatedairanduidsinthethorax(pleuralcavity,
mediastinum,pericardium)thatrequirecontrolled
drainage,monitoring,andbalancing.
Application organ: Thorax(pleuralcavity,mediastinum,pericardium)
Application time: Short-termuseonthepatient(<30days).
Application site: Theapplicationsiteistheclinicalenvironment.The
cardiothoracicdrainagesystemmayonlybeappliedby
healthcareprofessionals.Thedeviceisappliedunsterile.
Thesecretioncanisterandthehosesystemaresterileand
disposable;theycanbeusedinthesterileOTarea.
Patient selection criteria: Patientswhorequireacardiothoracicdrainage(pleura,
mediastinalorpericardialdrainage).
Indications: • Aftersurgicalopeningsofthethorax
• Pneumothorax
• Pleuraleusion
• Hemothorax
• Pleuralempyema
• Chylothorax
• Othersimilarclinicalpictures
Medical contraindications: • Notsuitableforcardiothoracicdrainagetherapyin
whichnovacuumshouldbeappliedtothepatient.

9
Other contraindications: • Noapplicationwithothercardiothoracicdrainage
systemsotherthantheATMOSC051Thorax,ATMOSS
201 Thorax and ATMOS E 201 Thorax
• Noseparateapplicationofthesecretioncanisterand
thehosesystem(i.e.withoutdevice)asgravitydrainage.
• Noapplicationunderemergencyconditions
• Shouldnotbeusedinthehomecaresectorwhichisnot
supervisedbyhealthcareprofessionals
• Nosuctionofammable,corrosiveorexplosiveuids/
gases
Warnings: Thefollowingcomplicationsmayoccurduringa
cardiothoracic drainage:
• Painduetoirritationoftheintercostalnerves
• Injuriestothelungparenchyma/airleak
• Re-expansion edema
• Eusionretention
• Tension pneumothorax
• Skin/softtissueemphysema
The product is: not active
Sterility / specic microbial
condition:
Hosesystemissterile.
Single-use product /
reprocessing:
Hosesystemisadisposableproduct.
1.3 Function
TheATMOSS201Thoraxisanexceptionallyhandy,portable,digitalthoracicdrainagesuction
device.Thedeviceisoperatedwithanelectrical,maintenance-freediaphragmpump.During
operationthepumpcreatesavacuumwithinthesuctionhoseandthesecretioncanisterby
meansofwhichsecretionandaircanbesuckedobythehosesystem.Thepumpiscontrolled
digitallyandthereforeensuresthatthechosenrequiredvacuumvalueisstable.Theairow,
whichismeasuredinrealtime,isdisplayedinnumbers.Atonekeypressowdatafromupto12
days is shown in graphic.
Thesecretioniscollectedinthesecretioncanister.Itscapacityis2l.Withtheaidofthe
measuringandrinsinghosethevacuumattheendofthehosesystemismeasured.Viathe
touchscreendisplaythetargetvacuumcanbesetmanually.Thesuctioncapacityisregulated
automatically.
Thehosesystemisrinsedwithairatregularintervalstopreventthecollectionofdebrisinthe
secretionhose.Thismeasurealsopreventssecretionfromintrudingintothemeasuringand
rinsinghoseorthatasyphoneectiscreated.
Thedeviceisequippedwitharechargeablebattery.Achargingunitwhichislocatedwithinthe
suctiondeviceguaranteesforthesecurechargingofthebattery.Thereforeitisimpossibleto
overchargethebattery.
Bacterialandviralltersinthesecretioncanisterandmeasuringhosepreventcontaminated
secretionsfromenteringthedevice.Asaccessoriesauniversalconnectionandacarryingstrap
canbeorderedseparately.Theseenableattachmenttothepatient'sbed,forexample,aswellas
mobilization.
Essential requirements:
• Createandmaintainaregulatedvacuumbetween-5and-100mbar.

10
1.4 Transport and storage
• Thedevicemayonlybetransportedinaupholsteredandprotectiveshippingbox.
• Pleasenotedownandimmediatelyreportanydamageswhichoccurredduringshipping.
PleasemakeuseoftheattachedQD434Deliverycomplaint/Returnshipmentformifyou
haveacomplaintorsendbackthedevice.
TheformQD434canalsobedownloadedfromourwebsitewww.atmosmed.com.
• Aftertransportofthedeviceintemperaturesbelow0°Corpriortorststartupitshouldbe
keptatroomtemperatureforatleastsixhours.Ifthedeviceisnotacclimatizeditmaynotbe
usedasdamagetothediaphragmsofthepumpcouldoccur.
• Ambientconditions:
- Transport/storage:
 −10...+50°C;
 30...95%airhumiditywithoutcondensationatairpressure700...1060hPa
- Operationandbatterycharging:
 +10...+35°C;
 30...95%airhumiditywithoutcondensationatairpressure700...1060hPa
- Operationaltitude:max.3000m
1.5 Explanation of pictures and symbols
In the operating instructions
DANGER
Warningofadangerthatwillresultinimmediatefatalorseriousinjury.Observethenecessary
measures.
WARNING
Warningofadangerthatcancausefatalorseriousinjury.Observethenecessarymeasures.
CAUTION
Warningofadangerthatcancauseminorinjury.Observethenecessarymeasures.
NOTICE
Noticeofadangerthatcandamagetheproductorotherobjects.Observethenecessary
measures.
Warningofadangerthatcancausefatalorseriousinjury.
i
Noticeofpotentialmaterialdamage.
Usefulinformationonthehandlingofthedevice.
1. Action.Proceedstepbystep.
»Resultofanaction.

11
·Generalinformation,numeration
-Sub-numeration
click Engage,checkcorrectt.
Followthearrows
Move,pluginthisdirection.
Turn,pushinthisdirection
Pleasepresswheredotindicates
Replace
Check
Symbols used for the ATMOS S 201 Thorax and its accessories
Medicaldevice
ThisdevicecomplieswiththerelevantrequirementsofEUregulations.
0124
ThisdevicecomplieswiththerelevantrequirementsofEUregulations.
E349855
ULMark
MEDICALEQUIPMENT
withrespecttoelectricalshock,re,and
mechanicalhazardsonlyinaccordancewith
UL60601-1/ANSI/AAMIES60601-1(2005)/
CAN/CSA–C22.2No.60601-1(2008)
ThisdevicecomplieswiththerelevantrequirementsoftheEurasianEconomic
Union.
GOSTCerticate(Russia)
UniqueDeviceIdentierofamedicaldevice
REF
Articlenumber

12
SN
Serialnumber
LOT
Batch code
Use-bydate
Manufacturer
Dateofmanufacture
Countryofmanufacture:Germany
Warning,payspecialattention
Consultoperatinginstructions
Followoperatinginstructions(blue)
Do not reuse
STERILE
Steriledevice
STERILE EO Sterilizedusingethyleneoxide
NON
STERILE Non-sterile
Doublesterilebarriersystem
Singlesterilebarriersystem
ProtectionclassIIdevice
AppliedparttypeCF
IP XO Specicationofthedegreeofprotectionagainsttheingressofsolidsand
moisture
Fuse

13
Donotuseifthepackagingisdamagedandfollowtheoperatinginstructions.
Fragile,handlewithcare
Keep dry
Keepawayfromsunlight
Temperaturelimit
Atmosphericpressurelimitation
Humiditylimitation
UDI application identier
(01) UDI-DI:Identicationofthemanufacturerandthedevice
(10) Batch code
(11) Dateofmanufacture
(17) Expiry date
(21) Serialnumber

14
2.0 For your safety
ThesafetyoftheATMOSS201Thoraxcomplieswiththeacceptedstandardsoftechnologyand
theguidelinesoftheGermanMedicalDevicesAct.
2.1 General safety instructions
Familiariseyourselfwiththedeviceingoodtimesothatyouarecapableofoperatingitatany
time.
Neveroperatethedeviceifitshowsanyobvioussafetydefects.
Onlyafullyfunctionalproductmeetsthesafetyrequirementsofusers,patientsandthird
parties.Therefore,pleaseobservethefollowinginstructionsonyourproduct:
2.2 Danger for users, patients, and third parties
WARNING
Electric shock due to unsuitable mains power connection, incorrect handling of the
product or damage to product components.
Burns,cardiacarrhythmiasandevenfatalinjuryarepossible.
• Donotoperatethedeviceifithasbeendropped.Inthiscase,cleananddisinfectthedevice
andsendittoATMOSforrepair.
• Ifthedevicehasfallen:Checkthedeviceforvisibledamage.Aleakagetestisrecommended.If
theleakagetestfailsorthehousingisdamaged,thedeviceisdefectiveandmustnotbe
operated.Inthiscase,cleananddisinfectthedeviceandsendittoATMOSforrepair.
• Priortoeachuse,checkfordamagetothedeviceandthepowercable.Donotoperatethe
deviceifyounoticeanydamage.Inthiscase,cleananddisinfectthedeviceandsenditto
ATMOSforrepair.
• Damagedcablesmustbereplaced.
• Youcanonlydisconnectthedevicefromthepowersupplybypullingoutthepowerplug.
• Positionthedevicesothatitcanalwaysbedisconnectedfromthepowersupplyeasily.
• Whendisconnectingthedevicefromthemainspowersupply,pullthepowerplugrstand
thenthedeviceplug.
• Disconnectthedevicefromthemainspowersupplybeforecleaningordisinfectingit.
• Nevertouchtheplugorpowercablewithwethands.
• Neverimmersethedeviceinwaterorotherliquids.
• Donottakeashower/bathwiththedevice!
• Thedeviceisnotsterilisable.
• Usethepowercableonlyindrysurroundings.Thesurroundingsmustbenon-conductive.
• Donotallowliquids(suchasdisinfectantsorsecretion)toenterthedeviceorpowercable.
• Ensurethatnoliquidentersthedevice.Ifliquidgetsintothedevice,operationofthedevice
mustceaseimmediately.Inthiscase,cleananddisinfectthedeviceandsendittoATMOSfor
repair or an authorised service partner.
• Ifdisinfectanthaspenetratedthedevice,thenitmustbedriedthoroughlyandsubsequently
aneciencycontrolmustbeconducted.Acheckshouldbecarriedouttoseewhetherthe
targetvacuumisreachedwhenthesystemisclosedandwhetheraow>10l/minis
establishedafterawhilewhenthesystemisopen.Ifnot,itmustnotbeoperateduntilithas
beencheckedbyanauthorisedservicepartnerorATMOSServicecentre.
• OnlyuseoriginalaccessoriesandoriginalsparepartsfromATMOS.Thisappliestothepower
cableinparticular.
• Followtheinstructionsregardingperiodictestsinchapter‘9.0Maintenanceandservice’on
page 53.
• Assembly,newsettings,alterations,extensions,andrepairsmayonlybecarriedoutby

15
authorizedpersons.
• Donotmodifythedevicewithoutthemanufacturer’spermission.
WARNING
Risk of infection from non-sterile products!
Deadlydiseasescanbetransmitted.
• Neverusecomponentsmarkedwith morethanonce.Thesecomponentsareintendedfor
singleuseonly.
• Repeatedreuseofcomponentswhicharemarkedwitha isforbidden.Thisproductisnot
re-sterilisable.Incaseofrepeatedreusethesecomponentslosetheirfunctionandthereisa
highinfectionrisk.
• Onlyusesterilepackagedpartswhenthepackagingisundamaged.
• Priortouse,checkthepackagingofthesterileproducts,thesecretioncanistersystem,andthe
hosesystemforintactness.Donotusedefectivesecretioncanistersorhosesystems.
• Repeatedreuseofsecretioncanistersandhosesystemscanleadtoinfections.
• Secretioncanistersandhosesystemshouldonlybeusedonceoneverypatient.
• Forhygienicreasonswerecommendanexchangeofbothsecretioncanisterandhosesystem
at the same time.
WARNING
Risk of infection due to patient secretion on the device!
Deadlydiseasescanbetransmitted.
• Alwaysweardisposableglovesifyoucouldcomeintocontactwithsecretion.
• Cleananddisinfectthedeviceaftereveryuse.
• Cleananddisinfectthedeviceaccordingtotheoperatinginstructions.
• Thedevicemustnotbeusedfollowingoversuction.
WARNING
Ensure that the device is always functional and ready for use
Yourpatientcanbeseverelyinjured.
• Ensurethatthedeviceisalwaysreadyforuse.
• Placethedevicewhereitiseasilyaccessible.
• Performafunctioncheckaftereachuse.
• ATMOSrecommendsalwayshavinganothersuctiondevicereadyathand.Thisallowsyouto
treatthepatientandperformsuctioningevenintheeventofdevicefailure.
• Pleaseobservethenotesontheelectromagneticcompatibility(EMC)ofthedevice.
• Ifthedevicehasfallen:Checkthedeviceforvisibledamage.Aleakagetestisrecommended.If
theleakagetestfailsorthehousingisdamaged,thedeviceisdefectiveandmustnotbe
operated.Inthiscase,cleananddisinfectthedeviceandsendittoATMOSforrepair.
• Thedeviceandthesecretioncanistermustalwaysbeusedinaverticalposition.Ifthedevice
shouldtiltitmustbeplaceduprightagaininordertoguaranteefaultlessoperation.Ifyouare
unsurewhetherthesecretioncanisterworksproperlyweadviseyoutoreplacethesecretion
canistertoensurethepatients’safety.
• Thedeviceshouldnotbecarriedbythehosesystem.
• Priortoeveryusethedeviceshouldbecheckedforleakagesatthestartoftherapy(see
chapter ‘Achangeofthebarchartwithowscalingfrom450ml/minto150ml/mintakesplace
automaticallyassoonasthehourlyaveragevalueislessthan150ml/min.Therecordingis
restartedintheprocess.’onpage30).Leakingconnectionscouldleadtoawrongevaluationof
thepatient’sstatusandcouldprolongthetherapy.Thusdocheckallconnectionsforleakages
topreventtheintrusionofadditionalair.
• Theleakagetestisrecommendedtocheckforleakagespriortoeachapplication.
• Thewarningmessage‘Deviceincriticaltilt’servesaspreventiveinformationtoavoid
malfunctioncausedbythedevicetiltingover(forexample,ablockedbacterialandvirallter

16
lterinthesecretioncanister).
• Theleakagetestfunctionandthewarningmessage‘Deviceincriticaltilt’areactivatedinthe
factorysettings.Ifthesefunctionsarenotdesired,theycanbedeactivatedintheusersettings
(chapter‘4.9Usersettings’onpage39).
• Minimalleakagescanindicatesmallleaksinthesystemortoirregularitiesinthecourseof
therapy.Thiscanbeexcludedbyclampingthepatientcatheterandasaresulttheowvalueis
reducedtozero.Ifnot,checkalltheconnectionsonthedevice,theconnectorsaswellasthe
Luerlockcapforleakage.Ifthereisstillonlyaminimalowvalueillustratedthenthereisan
internalleakageinthesystemwhichcannotberectiedbytheuser.Thiswillbecompensated
bythesystembutillustratedasaminimalowvalue.
• Ifthesecretioncanistertipsoverduringtemporarygravitydrainage,thefunctionalityofthe
waterlockforgravitydrainageisnolongerguaranteed.Thevacuumatthepatient’send
ceases,thusposingariskofarenewedpneumothorax.
• Inthecaseoflargerairleaksandinpatientswithstulas,thevacuumandthusthewater
columnintheriserquicklydroptozero.Thismeansthatthereisnovacuumatthepatient’s
end,thusposingariskofarenewedpneumothorax.
• Ifahigh(negative)vacuumoccurs(e.g.duetodeepinhalation),thewaterinthewaterlockcan
risethroughtheriser.Thevacuumatthepatient’sendceases,thusposingariskofarenewed
pneumothorax.
• ThedevicemaynotbeoperatedinMRIscanners(magneticresonanceimaging).
• TheATMOSS201Thoraxisamedicaldevicewhichissubjecttospecialsafetyregulations.It
musttobesetupandputintooperationinaccordancewiththeEMCregulations.Portableand
mobileRFcommunicationdevices(mobilephones)mayaecttheperformanceofthedevice.
WARNING
Avoid improper use.
Yourpatientcanbeseverelyinjured.
• Amisplaceddrainagesystemandamisplacedchesttubecouldhinderthedrainageofairand
liquids.Acompleteblockingofthesystemduringthedrainageofliquidsandaircouldcausea
riseinpressureandthusleadtoatensionpneumothorax.
• Employthedeviceonlyaccordingtoitsintendeduse.
• Theproductmayonlybeusedbymedicallytrainedpersonswhohavebeeninstructedinthe
handlingofthemedicalsuctionsystem.
• Pleaseselectthevacuumaccordingtothepatientandtheapplication.
• Observethevalidguidelines.
• Observethenotesonhygieneandcleaning.
• Alwaysplacethedrainagesystematthesameheightasthepatientscatheterandcheckthe
patienthoseforanybendsorcloggingwhichcouldhinderthedrainageofliquidandair.Never
placethedrainagesystemontheoor.
• Respondimmediatelytowarningmessage"Secretioncanisterfullorhoseblocked"/"Vacuum
toolow".Priortoexchangingthesecretioncanisterthechesttubemustbeclampedsothata
continuousvacuumisalwaysavailableatthepatient.
• Iftheuidlevelinthesecretioncanisteristoohighitcouldcauseablockageandthusa
tension pneumothorax.
• Checkthesecretioncanisteratregularintervalsandalwaysreplaceitwhenthemaximum
llinglevelisreachedtoensurethepatientssafety.
• Checkthehosesystematregularintervals.Observetheinstructionsissuedbytheattending
physician.
• Thebendingofthepatienthoseleadstoaninterruptionofthetherapyandincorrect
measurements.
• Thehosesystemmaynotbeclamped.Ideallyclampthechesttubewhenchangingthe
secretion canister.
• Priortotheremovalofthehoseconnectorthechesttubemustbeclamped.

17
• Faultyrespectivelydamagedcomponentsmustbereplacedimmediately.
• Avacuumover-50mbarcouldcausepainandinjurytothepatient.Avacuumover-50mbar
mayonlybeadjustedundermedicalindication.
WARNING
Explosion and re hazard.
Burnsandinjuriesarepossible.
• OnlyuseoriginalaccessoriesandoriginalsparepartsfromATMOS.Thisappliestothepower
cableinparticular.
• Neveroperatetheproductinpotentiallyexplosiveareasorinareasthatareoxygenated.
• Explosion-hazardousareasmaybecausedbytheuseofammableanaesthetics,skin
cleansingproductsandskindisinfectants.Theambientconditionsspeciedinthetechnical
data(chapter‘11.0Technicaldata’onpage57)mustbestrictlyobserved.
CAUTION
Contact may cause allergic reactions!
Yourpatientcanbeinjured.
• Thematerialsusedhavebeentestedfortheirtolerability.Inveryrarecases,contactwith
accessiblematerialsonthedeviceanditsaccessoriesmaycauseallergicreactions.Thisapplies
inparticulartocontactinjuriesinconjunctionwithprolongedcontact.Ifthisoccurs,seek
medicalattentionimmediately.
CAUTION
Tripping hazard due to cables.
Injuriesandfracturesarepossible.
• Laythepowercableproperly.
CAUTION
Avoid improper use
Yourpatientcanbeinjured.
• Operationofthesecretioncanisterfortemporarygravitydrainageisonlypermittedwith
312.1150.5and312.1120.0.For312.1140.0theusefortemporarygravitydrainageisprohibited
(seechapter‘7.0Accessories,consumablesandspareparts’onpage48).
• Metalparts(e.g.,clamps)mustberemovedbeforeuseinMRI.
• Onlyremovethesecretioncanisterwhentherapyisstopped.
• Itismandatorytollthewaterlockinthesecretioncanisterfortemporarygravitydrainage.
• Priortouse,thewaterlockmustbelledtotheprescribedllinglevel(2cm).
• Donotllthewaterlockabovealevelof2cm.
• Onlyusesterileliquidforllingthewaterlock.
• Everytimebeforeusingthesecretioncanistermakesurethatthellerofthewaterlockis
sealedwiththeplug.
• Fortemporarygravitydrainage,placethesecretioncanisterbelowthepatient'schestinan
uprightposition.Makesurethatthepatienthosehasnoloopsand/orkinks,asthiscould
hinderthedrainageofuidsandair.
• Tippingorfallingoverofthesecretioncanistermustbeavoided.
• Thepatienthoseandwaterlockmustbecheckedregularlybymedicalprofessionals.
2.3 Avoiding damage to the device
NOTICE
Damage to the device due to improper use!
Thedevicemaybecomedamaged.
• Ensurethatnoliquidentersthedevice.Ifliquidgetsintothedevice,operationofthedevice
mustceaseimmediately.Inthiscase,cleananddisinfectthedeviceandsendittoATMOSfor

18
repair or an authorised service partner.
• Alwaysplacethedeviceonarm,levelsurface.Thedevicemustalwaysbeinaverticalposition
when you use it.
• Useonlypowercablesthatfunctionproperly.
2.3.1 General information
• Compliancewithpropersurgicalproceduresandtechniquesistheresponsibilityofthetreating
physician.Observetheinstructionsissuedbytheattendingphysician.
• Theuserisobligedtoregularlycheckthefunctionalityofthedrainagesystemduring
operation.
• Thecontrolpanelmustbeclearlyvisibleandaccessiblefortheoperator.
• Thesecretioncanistermayonlybeusedfortemporarygravitydrainagewhenthewaterlockis
lled(llingheight2cm,H2Osterile).
• Thelevelintheriserofthewaterlockcorrespondstothevacuumappliedtothepatientduring
thetemporarygravitydrainage.Theuctuationsinthepatientvacuum,whicharesynchronous
withthepatient'sbreathing,canbeobservedintheriser.
• Theappearanceofairbubblesinthewaterlockindicatestheescapeofairfromthethorax.
• Whileusingthesecretioncanisterfortemporarygravitydrainage,thewarningmessagesas
wellasallmeasuringfunctionsandthehoserinsingfunctionarenotactive.
• Thedevicemayonlybeoperatedbyqualiedpersonnel.
• Theremovalofthesecretioncanisterfromthedeviceduringthetherapymayonlybe
performedbytrainedprofessionalswhoactinconformitywithguidelines.
• Areadytousesparedeviceincl.consumablesmustalwaysbeavailable.
• Thedevicesupportsthetherapyofthepatientitisnotasubstituteforthedoctors‘diagnosis.
• Thepatientshouldbesupervisedconstantlyinaccordancewiththeinternalrulesofthe
hospital.
i
Electromagnetic compliance, - damage to the device!
Thedevicemaybecomedamaged.
• TheATMOSS201Thoraxfullycomplieswiththeelectromagneticimmunityrequirementsof
standardIEC60601-1-2/EN60601-1-2„Electromagneticcompatibility-MedicalElectrical
Devices“.
i
Damage to the device due to improperly installed protective contact socket!
Thedevicemaybecomedamaged.
• TheATMOSS201ThoraxisdesignedinaccordancewithIEC60601-1/EN60601-1andwith
protectionclassll.
• Thedevicemayonlybeconnectedtoaproperlyinstalledprotectivecontactsocket.
• Priortorststartingup,checkwhetherthemainsvoltagespeciedonthetypeplatematches
thelocalmainsvoltage.
i
Storage and operation in an unsuitable environment.
Theelectronicscanbecomedamaged.
• Pleaseobservetheambientconditionsregardingtransport,storage,andoperation.
• Alwaysplacethedeviceonrm,levelground.Thedevicemustalwaysbeinaverticalposition
whenyouuseit.Otherwise,secretionmayenterthedevice.
i
Damage to the device due to low temperatures!
Thedevicemaybecomedamaged.
• Aftertransportofthedeviceintemperaturesbelow0°Corpriortorststartupitshouldbe
keptatroomtemperatureforatleastsixhours.Ifthedeviceisnotacclimatizeditmaynotbe
usedasdamagetothediaphragmsofthepumpcouldoccur.

19
i
Damage to device due to heat build-up!
Thedevicemaybecomedamaged.
• Do not cover the device during suction.
• Keepthedeviceandthepowercableawayfromotherheatsources.
• Donotplacethedevicedirectlynexttootherdevicesasthismaycauseexcessiveheatingof
the device.
• Thedeviceandthesecretioncanistershouldnotbedriedinamicrowaveoven.
• Thepowercableandthedevicemustbekeptawayfromhotsurfaces.
• Thedevicemayonlybeoperatedatroomtemperatureandshouldnotbesubjectedtodirect
solarirradiationasthiscouldleadtoerrors.
• Donotclosetheventilationslotsonthebottomofthedevice.Otherwisethedevicecould
overheat.
i
Exclusion of liability and warranty
If
• nooriginalATMOSpartsarebeingused,
• theadviceforuseintheseoperatinginstructionsisnotbeingobserved,
• improperuse,
• assembly,newsettings,alterations,extensionsandrepairshavebeencarriedoutbypersonnel
notauthorizedbyATMOS.
i
Advice on disposal
• Disposeofwrappingsaccordingly.
• Attentionmustbepaidtoallhospitalprotocolsregardingdisposalandinfectioncontrol.

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3.0 Setting up and starting up
3.1 Scope of delivery
TheATMOSS201Thoraxwassubjectedtoanextensivefunctionaltestandwascarefullypacked
prior to dispatch.
Onreceiptofthegoodspleasecheckthepackagingforanypossibledamageandcomparethe
contentsforcompleteness.(seebillofdelivery).
312.1000.0 ATMOS S 201 Thorax
1x Basic device
1xPowercable,L=3m 507.0859.1
1x Operating instructions
1xQuickreferenceguide
3.2 Device overview
Front side
1
2
3
4
5
1On/Osensor
2Touchscreen(touch-sensitive
display)
3Handle
4Light sensor
5Releasebuttonofsecretioncanister
6Connectionforsecretioncanister
7ConnectionforUSBashdrive
OnlyusetheUSB-connectionforthe
transferoftherapydata.Asoftware
updatemayonlybeperformedby
ATMOSoranauthorizedservice
person.
8
9
8Measuring and rinsing hose
connection
9Secretion hose connection
6
7