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Atmos ENT Operating Instructions Manual

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Operating Instructions
ATMOS®ENTexiblebre
endoscope
English
GA1GB.150252.0
2017-07Index02
2
Table of contents
1 Introduction ........................................................................................ 4
1.1 Notes on operating instructions ...............................................................4
1.2 Explanationofpicturesandsymbols .......................................................5
1.3 Intended use ...............................................................................................6
1.4 Function .......................................................................................................7
1.5 Intended users ............................................................................................7
1.6 Scopeofdelivery ........................................................................................8
1.7 Transport and Storage ...............................................................................8
2 Hints for your safety .......................................................................... 9
2.1 Generalsafetyinformation .......................................................................9
2.2 Dangerforusers,patientsandthirdparties ..........................................9
2.3 Avoiddamagetothedevice ................................................................... 10
3 Setting up and starting up .............................................................. 11
3.1 Deviceoverview ....................................................................................... 11
3.2 Preparingthedevice ............................................................................... 11
3.3 Usingwithotherdevices ........................................................................ 12
4 Operation .......................................................................................... 14
4.1 Prior to use ............................................................................................... 14
4.2 Potentialmovement................................................................................ 14
4.2.1 Deectingthetip .................................................................................. 14
4.3 Focussing .................................................................................................. 14
4.4 Afteruse ................................................................................................... 15
5 Cleaning and disinfection ............................................................... 16
5.1 Prepareforcleaning ................................................................................ 17
5.2 Manualcleaninganddisinfection ......................................................... 17
5.2.1 Stage I .................................................................................................... 18
5.2.2 Stage II ................................................................................................... 18
5.2.3 Stage III .................................................................................................. 19
5.2.4 Stage IV .................................................................................................. 19
5.2.5 PhaseV .................................................................................................. 19
5.2.6 Removestubborndepositsfromglasssurfaces.............................. 19
5.2.7 Concludecleaninganddisinfection ................................................... 19
5.3 Machinecleaninganddisinfection ........................................................ 20
5.4 Recommendeddisinfectants ................................................................. 21
5.4.1 Recommendedendoscopedisinfectants ......................................... 21
5.5 Sterilization .............................................................................................. 22
3
5.5.1 Preparingforsterilization ................................................................... 22
5.5.2 Gassterilization .................................................................................... 22
6 Maintenance and service ................................................................ 23
6.1 Functioncheck ......................................................................................... 23
6.2 Furthertests ............................................................................................. 23
6.2.1 Leakagetest .......................................................................................... 23
6.2.2 Checkingthebreoptics .................................................................... 24
6.2.3 Checkingtheglasssurfacesandthesurface ................................... 24
6.3 Sendinginthedevice .............................................................................. 25
7 Troubleshooting ............................................................................... 26
8 Disposal ............................................................................................. 28
9 Technical data .................................................................................. 29
10 For your notes .................................................................................. 30
4 Introduction
1 Introduction
1.1 Notes on operating instructions
Theseoperatinginstructionscontainimportantinstructionson
howtooperateyourproductsafely,correctlyandeectively.
Theseoperatinginstructionsservenotonlyfornewoperating
personneltobeinstructedinitsuse,butalsoforuseasa
referencemanual.Anyreprint-eveninextracts-onlyafter
writtenpermissionfromATMOS.
These operating instructions must always be kept available
near the device.
Care,periodtests,regularcleaningandproperapplicationare
indispensable.Thatincreases,amongotherthings,thereliability
andservice-lifeoftheproduct.
Maintenance,repairsandperiodtestsmayonlybecarriedout
bypersonswhohavetheappropriatetechnicalknowledgeand
arefamiliarwiththeproduct.Tocarryoutthesemeasuresthe
personmusthavethenecessarytestdevicesandoriginalspare
parts.
Perusechapter„2Hintsforyoursafety“onpage9,before
usingtheproductforthersttime.Thishelpsyouavoid
potentiallydangeroussituations.
TheproductbearstheCEmarkingCEaccordingtotheEC
Directiveofthecouncilformedicalproducts93/42/EECand
meetsthebasicrequirementsofAppendixIofthedirective.
Theproduct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declarationofconformityandourgeneralstandard
termsandconditionscanbeobtainedonourwebsiteat
www.atmosmed.com.
ThequalitymanagementsystematATMOShasbeencertied
accordingtointernationalstandardsENISO13485.
Theseoperatinginstructionsarevalidforthefollowingdevices:
• ATMOS®nasopharyngoscope3.2mm 950.0243.0
5Introduction
1.2 Explanation of pictures and symbols
In the operating instructions
DANGER
Warningofadangerwhichcausesimmediatedeathorseriousinjury.
Observethenecessarymeasures.
WARNING
Bewareofadangerwhichcancausedeathorseriousinjury.Observethe
necessarymeasures.
CAUTION
Bewareofadangerwhichcaneasilyhurtyou.Observethenecessary
measures.
ATTENTION
Indicationofadangerwheretheproductorotheritemscanbedamaged.
Observethenecessarymeasures.
Warningofadangerwhichcancausedeathorseriousinjury.
Informationregardingpossiblematerialdamagewhichcanbe
caused.
&Usefulinformationonthehandlingofthedevice.
1. Action.Gostepbystep.
»Resultofanaction.
On device and type plate
Refertotheoperating
instructions
Followoperating
instructions(blue)
Thisproductcomplieswith
therelevantrequirements
oftheEUDirective
TheUSFederalLaw
restrictsthisproductto
salebyorontheorderofa
physician.
Manufacturer Manufacturingdate
6 Introduction
SN Serialnumber REF Ordernumber
ApplicationparttypeBF
MR
Donotuseinmagnetic
resonance areas
NON
STERILE
Notsterile Professionaldisposal
1.3 Intended use
Name: ATMOS®ENTexiblebreendoscopes
Main function: TheapplicationoftheATMOS®ENTexible
breendoscopesisindicatedforendoscopic
procedures,fortheshorttermapplicationin
theoralcavityuptothepharynx,intheauditory
canaltotheeardrumandinthenasalcavityfor
thevisualizationoforicesandvisceralcavities.
Medical indication /
application:
Forapplicationonhumans
Specication of the
main function:
Highresolutionexiblebreendoscopewitha
pliableexibletip,whichenablesanextended
lineofvisionfrom0°to140°intwoopposite
directions.AllstandardC-mountadapterswith
cameraheadscanbeattachedtotheeyepiece,
thisenablesavideotechnicalimagetransmission
aslive-imageorarecordingasapictureand/or
lmfordocumentation.
User prole: Doctorsandmedicallytrainedpersonnel
Patient groups (e.g.
age, weight, health,
state):
Patientsofallageswithoutrestrictions,where
aendoscopicstandardexaminationistobe
performed.
Application organ: Oralcavity,nasalcavity,auditorycanal
Application time: Applicationupto60minutes
Application site: InENTpractices,outpatientdepartments,clinics,
operatingroomsandphoniatrists.
7Introduction
Contraindications: TheapplicationoftheATMOS®HNOexible
breendoscopeiscontraindicatedifendoscopic
procedures are contraindicated.
The product is: Notactive
Sterility: Notsterile
Single-use product/
reprocessing:
Nosingle-useproduct.Seecleaningand
disinfectinginstructionsintheoperating
instructions.
1.4 Function
ATMOS®endoscopesareindicatedforthevisualizationoforicesandbody
cavities.Dependingonthecross-section,lengthandlockingpossibilities,
eachoftheendoscopesisdesignedforaspecicpurposeinaparticular
eldofmedicine.
Thenaturaloricesareilluminatedviaextremelythinbreglassbres
whicharethinnerthanhumanhair.Withtheaidofacameraanimagecan
betransferredfromtheoricetothescreenordisplayviaasubstantially
largeramountofsimilarbreglassbres.
1.5 Intended users
Endoscopicproceduresmayonlybecarriedoutbyqualiedprofessionals
(e.g.doctors)withcorrespondingtrainingandfamiliaritywithendoscopic
procedures.Inthatregarditistheresponsibilityoftheuserto
continuouslyinformhimselffromthemanufacturerregardingindication,
contraindication,possiblecomplicationsandrisksaswellasfurther
developmentsintheendoscopicprocedures.
Athoroughunderstandingoftheprinciplesandmethodsusedinlaser
endoscopyandelectro-surgicalproceduresisnecessarytoavoidshockand
riskofburnstopatientsandusersaswellasdamagetootherequipment
andinstruments.
8 Introduction
1.6 Scope of delivery
• Flexiblebreendoscope
• Aluminiumcarryingcase
• Leakagetester
• Valvecap
• Operating Instructions
1.7 Transport and Storage
Onlytransportthedeviceinashippingcontainer,whichispaddedand
oerssucientprotection.
Ifdamageoccursduringtransport:
1. Documentandreportthetransportdamage.
2. SendtheproducttoATMOS,seeChapter„6.3Sendinginthedevice“on
page 25.
Environmental conditions for transport and storage:
• Temperature: -20...+70°C
• Relativeairhumidity: 5...95%withoutcondensation
• Airpressure: 70...106kPa
9Hintsforyoursafety
2 Hints for your safety
Thesafetyoftheproductcomplieswithalltherecognizedrulesof
technologyandtheDirectivesoftheMedicalDevicesAct.
Readandfollowthesafetyinformationcarefullybeforeusingtheproduct.
2.1 General safety information
Neveroperatethedevice,ifitshowsanyobvioussafetydefects.Checkthe
unitatregularintervalsforsafetyandfunction.
2.2 Danger for users, patients and third parties
Reduce the risk of infection for you and your patients!
Deadlydiseasescanbetransmitted.
• Cleananddisinfecttheproductaftereveryuse.
• Cleananddisinfectthedeviceaccordingtotheoperatinginstructions.
Avoid misapplication.
Yourpatientmaybeseriouslyinjured.
• Priortoeachuseafunctioncheckhastobeperformed.
• Alwayshaveareplacementlightsourceathandoruselightsources
whichhaveasubstitutebulb.
• ThesimultaneoususeofNMR(NuclearMagneticResonance)and
endoscopescanleadtodangersandartefacts.Observethenecessary
safetyinstructions.
Heat development on the light source.
Burnsarepossible.
• Attentionmustbepaidthattheendofthelightconductordoesnot
touchthetissue.
• Ifapplicable,rinsethesurgicaleldsuciently.
Onlyafullyfunctionalproductmeetsthesafetyrequirementsofusers,
patientsandthirdparties.Therefore,pleasealsoobservethefollowing
guidelinesconcerningyourproduct.
10 Hintsforyoursafety
2.3 Avoid damage to the device
Incorrect or careless handling of the product.
Theproductmaybedamaged.
• Avoidbendingtheexiblebreendoscopetightly,wrapittightly,or
subjectittostrongimpact.
• Donotrotate,pullorputpressureontheexibleparts.
• Alwaysallowtheproducttocooldowntoroomtemperaturewithout
anyadditionalcoolingmeasures.
Improper cleaning, disinfection and sterilization.
Theproductmaybedamaged.
• Observetheinstructionsforcleaning,disinfectionandsterilizationin
chapter„5Cleaninganddisinfection“onpage16.
11Setting up and starting up
3 Setting up and starting up
3.1 Device overview
12
3456
7
8
910 11
12
13
1Flexiblebreendoscopewithventvalve
2Ventvalve
3Diopteradjustment(focussing)
4DeectionleverUP/DOWN
5LightcableconnectionforACM1/BritishStandard(ontheopposite
sideofthehousing)
6Lens
7Transfersleeveforlightcable
8LightcablesleeveforAMCIconnection
9Lightcable
10 Lightcablesleeveforlightsources
11 Valvecap
12 Leakagetester
13 Siliconehose
3.2 Preparing the device
Theproductissuppliednon-sterile.
12 Setting up and starting up
1. Cleananddisinfectthedevicepriortorstuse.
2. Sterilizethedevicewhereitisnecessaryforthemedicalindication.
3.3 Using with other devices
Attentionmustbepaidthatdeviceswhichareusedwiththeendoscope
meetallsafetyrequirements.
Attentionmustbepaidwhenusingtheendoscopewithanelectromedical
device,thatthetermsandconditionsfortheapplicationpartarecomplied
withtypeBF(insulated,oatingapplicationpart).
Combinedwithlaser,HF-surgery,pneumaticorelectrohydraulic
lithotripters,varioustherapeuticapplicationsarepossible.
1. Observetheoperatingandsafetyinstructionsoftheapplieddevices
and accessories.
Using with high-frequency surgical devices
Explosion and  re hazard!
Burnsandinjuriesarepossible.
• Takethenecessarymeasurestoremoveoravoidformationof
combustiblegases.
Predominant depression in the tissue can be caused due to low and
unsuitable performance settings or incorrect application.
Seriousinjurytothepatientispossible.
• Thepatientmustbesuitablyprepared.
• Settheperformancesettingbasedonclinicalreferencesandonlywith
thenecessarytrainingandexperience.
• Onlyswitchonthehigh-frequencycurrentwhentheapplicationpart
(electrode)canbeseenthroughtheendoscope.
WARNING
13Setting up and starting up
Using with laser devices
Dangerous laser radiation.
Seriousdamagetotheeyesispossible.
• Wearsuitableprotectionglasses.
Burns and undesirable depressions in the tissue
• Thelaserperformanceshouldonlybeactivatedwhenthetipofthe
laserbrecanbeseenthroughtheendoscope.
WARNING
14 Operation
4 Operation
Danger of infection due to secretion on the endoscope.
Deadlydiseasescanbetransmitted.
• Alwayskeepausedendoscopeseparatefromotherreprocessed
instruments.
• Cleananddisinfecttheendoscopeaftereachusewithin6hours.
4.1 Prior to use
1. Connecttheaccessoriesandcomponents.
2. Performafunctioncheck.
&Checkthefunctionalityofaccessoriesandcomponents.
4.2 Potential movement
Theexiblebreendoscopecanbemovedinthreeways:
• Itcanbemovedinalldirectionsalongthelongitudinalaxis.
• Itcanberotated.
• Thedistalendcanbebent.
4.2.1 Defl ecting the tip
1. Pressthedeectionlever 1.
1
4.3 Focussing
1. Turnthediopteradjustment 2.
2
WARNING
15Operation
4.4 After use
1. Removeallusedadaptersfromthelightcableconnection.
2. Removethesealcapfromtheluer-lockconnection.
3. Visibleresidueshouldberemovedimmediatelyaftersurgeryusinga
lint-freedisposablecloth.
4. Transporttheproductdryinacloseddisposalcontainerforcleaning
anddisinfecting.
5. Cleananddisinfecttheendoscopeaftereachusewithin6hours.
16 Cleaninganddisinfection
5 Cleaning and disinfection
Werecommendyoutodocumentanymaintenanceworkandalsoany
exchangeofparts.
Itistheresponsibilityoftheoperatortoensurethattherequiredresultsfor
cleaninganddisinfectionareadheredto.Generallyvalidationandroutine
monitoringoftheprocedureisnecessary.
Theamountofprocessingcyclesdependsondierentfactorsandcannot
begeneralized.
Risk of infection due to secretion on the product and accessories.
Deadlydiseasescanbetransmitted.
• Alwaysweardisposableglovesduringanycleaning.
• Cleananddisinfecttheproductaftereveryuse.
• Cleananddisinfectthedeviceaccordingtotheoperatinginstructions.
• Observerelevantnationallegalregulationsandstandardsforcleaning,
disinfectionandsterilization.Thisappliesespeciallytopatientswith
suspectedCreutzfeldt-Jacob-Disease(CJD),orpossiblevariants.
Dried up residue after surgery due to wrong cleaning.
Corrosiondamageanddicultcleaningarepossible.
• Cleananddisinfecttheendoscopeaftereachusewithin6hours.
• Donotusepre-cleaningtemperatures>45°C.
• Donotusexingdetergentwiththesubstancealdehydeoralcohol.
WARNING
ATTENTION
17Cleaninganddisinfection
Incorrect cleaning and disinfectants.
Damagedsurface,fadedlasermarkingorchemicallydamagedproduct.
• Observethecorrectdosageforneutralizingagentsandbasiccleaners.
• Donotuseabrasives.
• Onlyusecleaninganddisinfectantagentswhicharerecommendedby
themanufacturerofendoscopes.
• Donotusecleaninganddisinfectantagentswhichcouldcausestress
cracksorcorrosioninplastic.
• ObservethatthepHvalueoftheapplicationsolutionis<8.
Incorrect cleaning and disinfection:
Damagedproduct.
• Nevercleantheproductinanultrasonicbath.
• Onlyusecleaninganddisinfectiondeviceswhicharesuitablefor
cleaningexiblebreendoscopes.
• Donotautoclavetheproduct.
• Onlyusetherecommendeddisinfectantagentsandsterilization
methods.
• Avoidexcessivepressureortensiontotheexibleprobearea.
• Ensurethatthebendingradiusoftheexibleprobeareaisatleast
40mm.
5.1 Prepare for cleaning
1. Priortoeverycleaninganddisinfectionaleakagetestmustbe
conducted,seechapter„6.2.1Leakagetest“onpage23.
5.2 Manual cleaning and disinfection
Onlycleanthedevicewhenitisleakproof.Seechapter„6.2.1Leakagetest“
on page 23.
Followingdisinfectionwithnon-virucidalagents,sterilizationmustbe
carried out.
ATTENTION
18 Cleaninganddisinfection
Stage Step Tempera-
ture
Time Concen-
tration
Water
quality
Chemistry
ICleaning 35-45°C/
95-113°F
5min 0.8% Drinking
water
Cidezyme/
Enzol1
II Intermedi-
ate rinsing
Roomtem-
perature
(cold)
3 X
1min
--- Drinking
water
---
III Disinfec-
tion
20-25°C/
68-77°F
12min --- Drinking
water
CidexOPA2
IV Final
rinsing
Roomtem-
perature
(cold)
3 X
2min
--- VE-W
sterile3
---
VDrying Roomtem-
perature
--- --- Drinking
water
---
1Enzymaticcleaner
2Ready-to-usesolution,0,55%orthophtalaldehyd
3Demineralizedwater(demineralised,lowgerms,maximum10germs/ml
andendotoxin-poor,maximum0.25endotoxinunits/ml)
5.2.1 Stage I
&Theconcentrationofthecleaningagentdependsonthecontamination
oftheproduct.Observethemanufacturer'sinstructionsforuseofthe
cleaningsolution.
1. Theproductmustbecompletelyimmersedinthecleaningsolutionso
thatallaccessiblesurfacesarecovered.
Damagedproductduetocleaningwithametalbrush.
2. Placetheproductinthesolutionandcleanwithasoftclothora
suitablesoftcleaningbrush.
» Thereisnovisibleresidueonthesurface.
3. Operatethemovablecomponentslikefocussinganddeectionleverin
thesolution.
4. Thoroughlyrinsethemovablecomponentswiththecleaningsolution,
atleast5times,usingadisposablesyringe(20ml)
5.2.2 Stage II
Usefreshwaterforeachrinsingcycle.
19Cleaninganddisinfection
1. Thoroughlyrinseallaccessiblesurfacesoftheproductthreetimesfor
atleast1minute.
2. Operatethemovablecomponentslikefocussinganddeectionleverin
thesolution.
3. Allowtherestofthewatertodraino.
5.2.3 Stage III
1. Theproductmustbecompletelyimmersedinthecleaningsolutionso
thatallaccessiblesurfacesarecovered.
2. Operatethemovablecomponentslikefocussinganddeectionleverin
thesolution.
5.2.4 Stage IV
Corrosiondamageduetochlorine-andchlorideresidues.
Usefresh,demineralisedwaterforeachrinseandrinsethoroughly.
1. Thoroughlyrinsetheproduct3timescompletely,allaccessible
surfaces,foratleast2minutes.
2. Operatethemovablecomponentslikefocussinganddeectionleverin
thesolution.
3. Allowtheremainingwatertodrainosuciently.
&Iftheproductisnotsucientlyrinsed,stubbornresiduecoulddevelop
ontheglasssurface.
5.2.5 Phase V
1. Drytheproductwithalint-freecloth.
2. Areaswhichcannotbeaccessedwithaclothmustbedriedwith
medical-qualitycompressedair(pmax.=0.5bar).
5.2.6 Remove stubborn deposits from glass surfaces
&Stubborndepositsdevelopwhenthedeviceisnotrinsedsuciently.
1. Cleantheglasssurfaceswithsuitablecleaningpasteorwithacotton
budsoakedinalcohol.
5.2.7 Conclude cleaning and disinfection
1. Checkwhetherallvisiblesurfacesarewithoutresidue.Ifresidueis
found,repeatthecleaninganddisinfection.
20 Cleaninganddisinfection
2. Ifyouhavedisinfectedwithnon-virucidaldisinfectants,youmust
sterilizetheproduct.
&Ifstubbornresiduecannotberemovedbycleaning,theproductmust
besenttoATMOSoranauthorizeddealer.
5.3 Machine cleaning and disinfection
Checkwhetheryourcleaninganddisinfectiondeviceforendoscopes
issuitablefortheATMOS®ENTexiblebreendoscope.Ifnecessary,
checkwiththemanufacturerofyourcleaninganddisinfectiondevicefor
endoscopes.
Onlycleanthedevicewhenitisleakproof.Seechapter„6.2.1Leakagetest“
on page 23.
Followingdisinfectionwithnon-virucidalagents,sterilizationmustbe
carried out.
1. Iftheendoscopeishighlycontaminated,thencleanitmanually
beforehand.
2. Removethevalvecapfromtheventvalve.
Damagedendoscopeduetoconnectionofthewronghose.
3. Connectthepressureequalizationhoseofthecleaninganddisinfection
deviceforendoscopestothevalvecap.Ifnecessaryuseanadapter.
Damagedendoscopefromtemperatures>65°C.
4. Selectasuitablecleaninganddisinfectionprogramwithatemperature
<65°C.
5. Cleananddisinfecttheendoscope.
6. Checkwhetherallvisiblesurfacesarewithoutresidue.Ifresidueis
found,repeatthecleaninganddisinfection.
7. Soakacottonbudinlenscleanerorwith70%-Isopropylalkohol.
8. Cleanthefollowingpartswithacottonbud,wipingwithcircular
movements:
• Objective(distalend)
• Eyepiece
• Lightguideconnection
9. Ifyouhavedisinfectedwithnon-virucidaldisinfectants,youmust
sterilizetheproduct.
&Ifstubbornresiduecannotberemovedbycleaning,theproductmust
besenttoATMOSoranauthorizeddealer.
/