Atmos ENT Operating Instructions Manual

Brand: Atmos

Model: ENT

Type: Operating Instructions Manual

Operating Instructions

ATMOS®ENTexiblebre

endoscope

English

GA1GB.150252.0

2017-07Index02

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

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

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

3456

910 11

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.

4.3 Focussing

1. Turnthediopteradjustment 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.

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Atmos ENT Operating Instructions Manual

Atmos ENT Operating Instructions Manual

Atmos ENT Operating Instructions Manual

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