Ambu aScope Duodeno User manual

For use by trained clinicians/physicians only.
For in-hospital use.
For use with Ambu® aBox™ Duodeno.
Instruction For Use
Ambu® aScope™ Duodeno

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aBox
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Ambu is a registered trademark and aScope™ Duodeno is a trademark of Ambu A/S.
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Table of Contents
1. ImportantInformaon–PleaseReadBeforeUse! 4
1.1 IntendedUse/IndicaonForUse 4
1.2 GeneralInformaon 4
1.3 Contraindicaons 4
1.4 WarningsAndCauons 5
2. SystemDescripon 10
2.1 System Components 10
2.2 Compable/ApplicableDevice 10
2.3 aScope™DuodenoDescriponAndFuncon 10
3. ExplanaonOfSymbolsUsed 12
4. PreparaonsForUse 13
4.1 PreparaonAndInspeconOfTheaScope™Duodeno 13
4.2 PreparaonOfTheEndoscope 14
4.3 AachingAncillaryEquipmentToTheEndoscope 14
4.4 OperangTheaScope™Duodeno 16
5. EndingAProcedure 17
5.1 ConcludingAPaentProcedure 17
6. AerUse 17
7. Technical Data 18
7.1 aScope™ Duodeno 18
7.2 StorageAndOperaonEnvironmentSpecicaons 18
7.3 ListOfAncillaryEquipment 19
7.4 Accessories 19
8. Troubleshoong 19
8.1 Angulaon,BendingAndLockingLevers 19
8.2 RinsingAndInsuaon 20
8.3 Sucon 21
8.4 Instrument Channel 21
8.5 Image Quality And Brightness 22
8.6 Remote Switches 23
9. Compliance And Licensing 23
10. ElectromagnecCompability 23
11. Contact 26
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1. ImportantInformaon–PleaseReadBeforeUse!
ReadthisInstructionsForUse(IFU)carefullybeforeusingtheaScope™Duodenoandkeepforfuture
reference.FailuretoreadandthoroughlyunderstandtheinformationpresentedinthisIFU,aswell
asthosedevelopedforancillaryendoscopicequipmentandaccessories,mayresultinseriousinjury
tothepatientand/oruser.Furthermore,failuretofollowtheinstructionsinthisIFUmayresultin
damageto,and/ormalfunctionof,theequipment.
This IFU describes the recommended procedures for inspecting and preparing the system prior
toitsuse. Itdoesnotdescribehowan actualprocedureis tobe performed,nordoesitattempt
t o  t e a c h  t h e  b e g i n n e r  t h e  p r o p e r  t e c h n i q u e  o r  a n y  m e d i c a l  a s p e c t s  r e g a r d i n g  t h e  u s e  o f  t h e 
equipment.Itistheresponsibilityofeachmedicalfacilitytoensurethatonlyappropriatelytrained
personnel, who are competent and knowledgeable about endoscopic equipment, antimicrobial
agents/processesandhospitalinfectioncontrolprotocolareinvolvedintheuse,handlingandthe
careofthesemedicaldevices.TheIFUmaybeupdatedwithoutfurthernotice.Copiesofthecurrent
versionareavailableuponrequest.
1.1 IntendedUse/IndicaonForUse
T h e  a S c o p e ™  D u o d e n o  i s  d e s i g n e d  t o  b e  u s e d  w i t h  t h e  a B o x ™  D u o d e n o ,  e n d o s c o p i c 
accessories(e.g.biopsyforceps)andotherancillaryequipment(e.g.medicalgradevideomonitor)
for endoscopy and endoscopic surgery within the duodenum.
Note: Do not use this instrument for any purpose other than its intended use. Select the
endoscopetobeusedaccordingtotheobjecveoftheintendedprocedurebasedonthefull
understandingoftheendoscope’sspecicaonsandfunconalityasdescribedinthisIFU.
1.2 GeneralInformaon
TheoperatorsofthesystemarephysicianstrainedindiagnoscandtherapeucGIEndoscopy.Ifthere
are ocial standards for user qualicaons to perform endoscopy and endoscopic treatment that
are dened by the hospital´s medical administrators or other ocial instuons, such as academic
sociees on endoscopy, follow those standards. If there are no ocial qualicaon standards, the
operator of this instrument must be a physician approved by the medical safety manager of the
hospitalorpersoninchargeofthedepartment(departmentofinternalmedicine,etc.).
T h e  p h y s i c i a n  s h o u l d  b e  c a p a b l e  o f  s a f e l y  p e r f o r m i n g  t h e  p l a n n e d  e n d o s c o p y  a n d  e n d o s c o p i c 
treatmentfollowingguidelinessetbytheacademicsocieesonendoscopy,etc.,andconsidering
t h e  d i  c u l t y  o f  e n d o s c o p y  a n d  e n d o s c o p i c  t r e a t m e n t .  T h i s  m a n u a l  d o e s  n o t  e x p l a i n  o r  d i s c u s s 
endoscopic procedures.
Additionalequipmentconnectedtomedicalelectricalequipmentmustcomplywiththerespective
IECorISOstandards(e.g.IEC60950orIEC62368fordataprocessingequipment).Furthermoreall
configurations shall comply with the requirements for medical electrical systems (see clause 16
o f  t h e  l a t e s t  v a l i d  v e r s i o n  o f  I E C  6 0 6 0 1 - 1 ) .  A n y b o d y  c o n n e c t i n g  a d d i t i o n a l  e q u i p m e n t  t o  m e d i c a l 
electrical equipment configures a medical system and is therefore responsible that the system
c o m p l i e s  w i t h  t h e  r e q u i r e m e n t s  f o r  m e d i c a l  e l e c t r i c a l  s y s t e m s .  I f  i n  d o u b t ,  c o n s u l t  y o u r  l o c a l 
representativeorthetechnicalservicedepartment.
1.3 Contraindicaons
ContraindicaonsforERCPincludethefollowing:
• Paensunder18years.
• Whentheriskstopaenthealthorlifearejudgedtooutweighthemostfavorablebenets
of the procedure.
• Whenadequatepaentcooperaonorconsentcannotbeobtained.
• Whenaperforatedviscusisknownorsuspected.
Addionalcontraindicaonscouldexistforhighriskproceduressuchasbiliarysphincterotomyina
paentwhoisfullyancoagulatedwithCoumadinortherapeucallydosedwithclopidogrel.
FollowingcondionsmayaswellcontraindicateERCPandneedtobequalied:
• paenthassueredapriorsevereallergicreacontoERCPcontrastmedium
• unstablecardiopulmonary,neurologicorcardiovascularstatusofthepaent
• severeuncorrectedcoagulopathy
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1.4 WarningsAndCauons
Failure to observe these warnings and cauons may result in paent injury or damage to the
equipment.Ambuisnotresponsibleforanydamagetothesystemorpaentinjuryresulngfrom
incorrect use.
Warnings
Indicatesapotenallyhazardoussituaonwhich,ifnotavoided,couldresultindeathorserious
injury.
ConneconofDevices
• Donotconnectnon-medicalgradedevicestotheendoscope.Conneconofdevicesthat
are not medical grade (IEC 60601 conform) could have negave impact on the safety
o f  t h e  s y s t e m .  C o n n e c t  o n l y  m e d i c a l  g r a d e  e q u i p m e n t  t o  t h e  e n d o s c o p e .  F o r  d e t a i l e d 
informaonconsulttheIFUoftheaBox™Duodeno.
Single-Use&Cross-Contaminaon
• TheendoscopedescribedinthisIFUisasingle-usemedicaldevice.Sinceitispackagedas
sterile,itmustbeproperlyhandled(byusingasepctechnique)andstoredtoensurethe
sterilepackagingisnotbreachedpriortouse.
• DonotaempttocleanandreusetheaScope™Duodenoasitisasingle-usedevice
andcannotbereprocessed.Reuseoftheproductcancausecontaminaon,leadingto
infecons.
• Do not use the aScope™ Duodeno if the product sterilizaon barrier or its packaging is
damaged.
• A new bole of sterile water with at least 1000ml in volume should be used for each
procedure.Usinganopenedboleofwatermayleadtocross-contaminaonorinfecon.
• To guard against dangerous chemicals and potenally infecous material during the
procedureanddangerofunintenonaldiathermyburns,wearpersonalprotecveequipment
suchaseyewear,facemask,moisture-resistantclothing,andchemicalandelectrical-resistant
glovesthattproperlyandarelongenoughsothatyourskinisnotexposed.Pleasenotethat
anewpairofglovesisrequiredpriortoeachprocedure.
PreparaonforUse
• Beforeendoscopy,remove anymetallicobjects(watch,glasses,necklace,etc.)from the
paent.Performinghigh-frequencycauterizaontreatmentwhile thepaentiswearing
metallicobjectsmaycauseburnsonthepaentinareasaroundthemetallicobjects.
• Usinganendoscopethatisnotfunconingproperlyorissuspectedtobedefecvemay
compromisepaentoroperatorsafety andcouldpotenallyresult insevereequipment
damage.Inspecttheendoscopefordamages prior to use. Checkthefunconalityof the
endoscopepriortouse.Besurealwaystohaveanotherendoscopeavailableandreadyfor
usetoavoidanyunnecessarydelayduetoequipmentfailureormalfuncon.
OperatorInstrucons
• Do not strike, hit, or drop the endoscope’s distal end, inseron tube, bending secon,
controlsecon,umbilicus,and/orendoscopeconnector.Also,donotbend,pull,ortwist
theendoscope’sdistalend,inserontube,bendingsecon,controlsecon,umbilicus,or
endoscopeconnectorwithexcessiveforce.Theendoscopemaybedamagedandcould
causepaentinjury,burns,bleeding,and/orperforaons.Itcouldalsocausepartsofthe
endoscopetofalloinsidethepaent.
• Donotstaredirectlyintothedistalendof theendoscopeandavoidpaenteyecontact
withthe distalendoftheendoscopewhile theexaminaon light is ON. Keepyour eyes
away from the distal end when inserng endoscopic accessories as eye injury could
potenallyresult.
• Nomodicaonofthisequipmentisallowed.
• DonotleavetheendoscopeilluminatedbeforeandaerexaminaonotherwisetheLEDs
couldbedirectedtowardtotheopenedeyesofthesedatedpaentandcancauserena
burns.
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Ancillary Equipment
• IfcombinaonsofancillaryequimentotherthanthosedescribedinthisIFUareused,full
responsability is assumed by the medical treatment facility.
• Adefecvevacuumpumpcouldleadtoalossofcoolingandincreasedtemperatureat
thepoftheendoscope.Makesuretohaveanothervacuumsourceavailable.
OperaonoftheEndoscope
• Never perform angulaon control forcibly or abruptly. Never forcefully pull, twist, or
rotate the angulated bending secon. Paent injury, bleeding, and/or perforaon
mayresult.Itmayalsobecomeimpossibletostraightenthebendingseconduringan
examinaon. Never operate the bending secon, feed air or perform sucon, insert
orwithdrawthe endoscope’sinseronsecon,oruseendoscopic accessorieswithout
viewing the live endoscopic image or when the image is frozen or magnied. Paent
injury,bleeding,and/orperforaonmayresult.
• Neverinsert,withdraworoperatetheinseronseconabruptlyorwithexcessiveforce.
Paentinjury,bleeding,and/orperforaonmayresult.
• Neverinsertorwithdrawtheendoscope’sinseronseconwhilethebendingseconis
bentorlockedinposion.Paentinjury,bleeding,and/orperforaonmayresult.
• N e v e r  i n s e r t  o r  w i t h d r a w  t h e  e n d o s c o p e  w h i l e  t h e  e l e v a t o r  i s  r a i s e d ,  o r  w h e n 
endoscopicaccessoryextendsfromthedistalendoftheendoscope.Otherwise,paent
injury,bleeding,and/orperforaoncanresult.
• Firmlyconnectthesucontubefromthesuconpumptothesuconconnectoronthe
endoscope.Ifthesucontubeisnotaachedproperly,debrismaydripfromthetube
andcanposeaninfeconcontrolrisk,causeequipmentdamage,and/orreducesucon
capability.
• Ifthesterilewaterlevelinthewaterboleistoolow,replacethebolewithanewone.
Anemptybolecancauselossofrinsingandcoolingfuncon.Alwayskeepanewbole
of sterile water ready for this case.
• Ifbloodunexpectedlyadherestothesurfaceoftheinseronseconofthewithdrawn
endoscope,carefullycheckthecondionofthepaent.
• Donotusetheendoscopeifanypartsoftheendoscopeorendoscopicaccessoryfallo
insidethepaentbodyduetoequipmentdamageorfailure.Stopusingtheendoscope
immediatelyandretrieveallpartsinanappropriateway,otherwiseseriouspaentinjury
may occur.
Image
Alwayscheckwhethertheimageonthescreenisaliveimageorarecordedimageandverify
thattheorientaonoftheimageisasexpected.Donotusethisdeviceiftheliveimagecannot
beobserved,otherwisepaentinjurymayoccur.
• Always set the intensity of electrosurgical instruments to the lowest required value
to avoidimage disturbance. Do not increase thelevel of intensity above the standard
ERCP sengs.Always limit the connuousacvaon me of electricalinstruments to
a minimum.
• If an abnormal endoscopic image appears or an abnormal funcon occurs but
q u i c k l y  c o r r e c t s  i t s e l f ,  t h e  e n d o s c o p e  m a y  h a v e  m a l f u n c  o n e d .  I n  t h i s  c a s e ,  c o n s i d e r 
abandoningtheprocedurebecausetheirregularitycanoccuragain,andtheendoscope
may not return toits normal condion. Stop theexaminaon immediately andslowly
withdrawtheendoscopewhileviewingtheendoscopicimage.Otherwise,paentinjury,
bleeding,and/orperforaoncanresult.
Over-insuaon&gas
• Conrmthatthetophole oftheinsuaon/rinsingvalveis not blocked.Iftheholeis
blocked,airisfedconnuouslyandpaentpain,bleeding,and/orperforaoncanresult.
• Donotinateairoranonammablegasexcessivelyintothepaent.Thiscouldcausegas
embolismand/orover-insuaon.
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• Donotinsuateammablegasintothepaentotherwisepaentinjurymayoccur
Distal-end Temperature
• The temperature of the distal end of the endoscope may exceed 41˚C (106˚F) and
reach 50˚C (122˚F) due to intense endoscopic illuminaon. Therefore, do not leave the
endoscopeilluminatedbeforeand/oraeranexaminaonandalwaysmaintainasuitable
distance necessary for adequate viewing while using the minimum level of illuminaon
fortheminimumamountofme.Connuedilluminaonwillcausethedistalendofthe
endoscopetobecomehotandcouldcauseoperatorand/orpaentburns.Donotleavethe
endoscopeilluminatedbeforeandaerexaminaon.
• Avoidlongperiodsofcontactbetweenthepofthedeviceandthemucosalmembrane,
sustained contact with the mucosal membrane may cause mucosal injury. The distal
endoftheendoscopemaygetwarmduetoheangfromthelightemissionpart.When
withdrawingtheendoscope,thedistalendshouldbeintheneutralandnon-deected
posionwiththebrakesreleased.
BiospyValve
• Beforeusingasyringetoinjectliquidthroughthebiopsyvalveorwhenaspirang,detach
thevalve’scapfromthemainbody.Ifthecapisnotdetachedand/orthesyringeisnot
insertedstraight,thebiopsyvalvecouldbedamaged.Thiscouldreducetheecacyof
theendoscope’ssuconsystem,andmayleakorspraypaentdebrisoruids,posingan
infeconcontrolrisk.Ifthebiopsyvalveisleuncappedduringthe procedure,debris
oruidscouldleakorsprayfromit,posinganinfeconcontrolrisk.Whenthevalveis
uncapped,placeapieceofsterilegauzeoverittopreventleakage.
• Paentdebrismightspraywhenendoscopicaccessoriesarewithdrawnfromthebiopsy
valve.Topreventthis,holdapieceofgauzearoundtheaccessoryandthebiopsyvalve
during withdrawal.
• Do not let the endoscopic accessory hang down from the biopsy valve. Doing so can
createaspacebetweentheaccessoryandthevalve’sslitorhole.Thiscandamagethe
valve,whichcanreducetheecacyoftheendoscope’ssuconsystemandmayleakor
spraypaentdebrisoruids,posinganinfeconcontrolrisk.
• Donotusethebiopsyvalveifanyirregulariesareobservedduringtheinspecon.An
irregular,abnormal,ordamagedvalvecanreducetheecacyoftheendoscope’ssucon
system,andmayleakorspraypaentdebrisoruids,posinganinfeconcontrolrisk.
Replace with a new one if necessary.
Endoscopic Accessories
• When using endoscopic accessories make sure the accessory remains visible in the
endoscopic image. If the posion of the accessory cannot be seen in the endoscopic
image,seriouspaentinjuryand/orequipmentdamagemayoccur.
• Wheninserngorwithdrawingan endoscopic accessory,conrmthat itsdistal end is
closed or completely retracted into the sheath. Make sure to straighten the bending
secon as much as possible. Inserng or withdrawing endoscopic accessories with
excessiveforcemaydamagetheworkingchannelortheendoscopicaccessories.Slowly
insert or withdraw the endoscopic accessory straight into or from the slit of the biopsy
valve.Otherwise,thebiopsyvalvemaybedamagedandpiecesofitcouldfalloand/or
causepaentinjury.
• Do not insert endoscopic accessories without the elevator being raised. If they are
i n s e r t e d  w i t h o u t  t h e  e l e v a t o r  b e i n g  r a i s e d ,  t h e  a c c e s s o r y  c a n n o t  b e  o b s e r v e d  i n  t h e 
endoscopicimageanditmaycausepaentinjury.
• Check the movement of the endoscopic accessory by slowly operang the elevator
control leverseveral mestoraisetheelevator. Otherwise, the endoscopicaccessory
maymoveinunexpecteddirecons,andpaentinjury,bleeding,and/orperforaonmay
result.
7

• Locate the endoscopic accessories as central as possible in the endoscopic image by
adjusng the posion of the distal end of endoscope, parcularly while performing
papillotomy.Whenthedistalendofendoscopicaccessoryisposionedintheleorright
sideoftheendoscopicimage,and the elevatorcontrolleverisoperated,the endoscopic
accessorymaymoveabruptly,resulnginpaentinjury,bleeding,and/orperforaon.
• D o  n o t  u s e  e x c e s s i v e  f o r c e  w h e n  o p e r a  n g ,  i n s e r  n g  o r  w i t h d r a w i n g  e n d o s c o p i c 
accessoriesandmakesuretheaccessoryisvisibleontheendoscopicimage.Otherwise,
the endoscopicaccessory mayextendfromthe distalend of the endoscope abruptly,
which could cause paent injury, bleeding, and/or perforaon. Never emit high-fre-
quencycurrentbeforeconrmingthatthedistalendofthehigh-frequencyendoscopic
accessoryisintheendoscope’seldofview.Also,conrmthattheelectrodeseconand
themucousmembraneinthevicinityofthetargetareaareatanappropriatedistance
fromthedistalendoftheendoscope.Ifthehigh-frequencycurrentisemiedwhilethe
distalendoftheendoscopicaccessoryisnotvisibleortooclosetothedistalendofthe
endoscope, paent injury, bleeding, and/or perforaon as well as equipment damage
can result.
• Whilemovingtheelevator,donotopenorclosethedistalendoftheendoscopicaccessory,
orextendtheneedleoftheinstrument.Thiscoulddamagetheendoscopicaccessoryand
couldcausepaentinjury,bleeding,and/orperforaon.Iftheendoscopicaccessorycannot
beinsertedor withdrawn,the distalend ofthe endoscopic accessorycannotbe opened
orclosed,ortheneedleoftheinstrumentcannotbeextended,movetheelevatorcontrol
leverintheoppositedireconofthe"Up"direcontolowertheelevator.
• When the device is used with energized endoscopic devices, leakage current may be
addive. Use onlyendoscopic devicesoftypeBF orCF.Checkthecompabilityof the
accessory/endoscopicdevicebeforeusetoanycriteriaforsafeuse.
Sucon
• Avoid aspirang solid maer or thick uids; instrument channel, sucon channel, or
suconvalvecloggingcanoccur.
• Whenaspirang,maintainthesuconpressureatthelowestlevelnecessarytoperform
theprocedure.Excessivesuconpressurecouldcauseaspiraonofand/orinjurytothe
mucousmembrane.Inaddion,paentuidscouldleakorsprayfromthebiopsyvalve,
posinganinfeconcontrolrisk.
Cautions
Indicatesapotentiallyhazardoussituationwhich,ifnotavoided,mayresultinminorormoderate
injury.Itmayalsobeusedtoalertagainstunsafepracticesorpotentialequipmentdamage.
General
• USfederallawrestrictsthisdeviceforsaleonlyby,orontheorderof,aphysician.
• KeeptheaScope™Duodenodryduringpreparaon,useandstorage.
• TheaScope™Duodenoisnotintendedtoberepaired.IfdefecvetheaScope™Duodeno
shouldbereturnedtoAmbu.FormoreinformaonpleaserefertoSecon6.1.
• Electromagnecinterferencemayoccuronthisinstrumentnearequipmentmarked
with the following symbol orotherportableandmobileRF(radiofrequency)
communicaonsequipment,suchascellularphones.Ifelectromagnecinterference
occurs,migaonmeasuresmaybenecessary,suchasreorienngorrelocangthis
instrument,orshieldingthelocaon.
UnpackingandPlacingtheEndoscope
• Donotuseaknifeoranothersharpinstrumenttoopenthepouchorcardboardbox.
• PlacetheaScope™Duodenoonalevelsurfacewhileunpacking.DroppingtheaScope™
Duodeno could damage it.
8

EN
PriortoUse
• Topreventthepaentfrombingtheendoscopeisrecommendedthatamouthpiecebe
placedinthepaent’smouthbeforeinserngtheendoscope.
• Never use a mouthpiece that is deformed, damaged or shows other irregularies,
otherwisepaentinjuryand/orequipmentdamagemayoccur.
• Topreventthepaentfrombreakingoneormoreteeth,makesuretherearenoteeth
thatarenotpermanetlycappedornomissingteeth,priorexaminaon.
• To prevent the paentof losing adentalprosthesis, make sure the paent removesit
priortoexaminaon.
• Donotallowthesuconcanistertollcompletely.Thesuconcanistermustbechanged
aer each examinaon. Using a lled sucon canister may lead to loss of the sucon
funcon,lossofcoolingormalfunconofthesuconpump.
OperangtheEndoscope
• Becarefulnottodamage theinserontubeor distalend when usingsharp devicesin
combinaonwiththeaScope™Duodeno.Theendoscopeconnectorwilldisconnectfrom
the endoscopeconnectorsocketontheaBoxDuodenoandtheendoscopic imagewill
be lost.
• Becarefulwhenhandlingthedistalendoftheinserontubeanddonotallowittostrike
otherobjects,asitmayresultindamagetotheequipment.Thelenssurfaceofthedistal
endisfragileandvisualdistoronmayoccur.
• Donotcoiltheinserontubeortheumbilicusinadiameteroflessthan12cm.Equipment
damage can result.
• Do not aempt to bend the endoscope’s inseron secon with excessive force.
Otherwise,theinseronseconmaybedamaged.
• Donottwistorbendthebendingseconwithyourhands.Equipmentdamagemayresult.
• Theendoscope’sremoteswitchescannotberemovedfromthecontrolsecon.Pressing,
pulling,ortwisngthemwithexcessiveforcecanbreaktheswitchesand/orcausewater
leaks.
• The endoscope’s insuaon and rinsing valves cannot be removed from the control
secon.Pressing,pulling,ortwisngthemwithexcessiveforcecanbreaktheswitches
and/orvalveswhichwillleadtolossoffunconality.
• Donotapplyoliveoilorproductscontainingpetroleum-basedlubricants(e.g.Vaseline®)
totheendoscope.Theseproductsmaycausedeterioraonoftheendoscope.Useonly
medicalgradelubricantswhicharefreeofparansandsilicone.
• If remote switches and/or insuaon and rinsing valves are not returning to the OFF
posionaerbeingpressedstronglyfromtheside,gentlypullthemupwardstoreturn
ittotheOFFposion.
Endoscopic Accessories
• Donotusedamagedendoscopicaccessories.Shouldanyirregulariesbeobservedduring
usetakeappropriatemeasurestoavoidpaentinjuryand/ordamagetoequipment.
9

2. SystemDescripon
2.1 System Components
Ambu® aScope™ Duodeno
Sterileandsingle-usedevice
Partnumber DistalEndOuter
Diameter ø
Working Channel
Inner Diameter ø
482001000 41.2 Fr
(13.7 mm)
12.6 Fr
(4.2 mm)
TheaScope™Duodenoisnotavailableinallcountries. Fordetailedinformaonplease contact
yourlocalsalesoce.
2.2 Compable/ApplicableDevice
Ambu®aBox™Duodeno
Reusabledevice
Partnumber
485001000US
TheaBox™Duodenoisnotavailableinallcountries.Fordetailedinformaonpleasecontactyour
localsalesoce.
2.3 aScope™DuodenoDescriponAndFuncon
TheaScope™Duodeno is aexible endoscope withside viewing opcs, deectable p and an
elevatortocontroltheposionofinsertedaccessories.Theendoscopepdeeconiscontrolled
viawheels,thedeecngcanbelockedvialocklevers.Theelevatoratthepcanbecontrolled
via deecon control at the control secon. Insuaon, sucon and rinsing funcons can be
acvatedviavalves.
17
13
12
18
14 15
16
20
19
23
21
22
1
3
4
5
6
8
9
10
11
7
2
2
R
F
L
D
U
10

EN
No. Part Function
1Elevatorcontrollever
R
F
L
D
U
Elevator up
Elevator down
When this lever is moved in the “Up” direcon, the
elevator is raised. When the lever is moved in the
oppositedirecon,theelevatorislowered.
2Remote switches Programableswitchesfore.g.freeze,recordvideo,
imagecapture.Thefunctionoftheremoteswitches
can be set on the aBox™ Duodeno. Refer to the IFU
of the aBox™ Duodeno when setting these functions.
Thestandardconfigurationoftheseswitchesare:
Remote switch 1 for image capture
Remote switch 2 no setting
Remote switch 3 no setting
3Lockleverup-down
R
F
L
D
U
Lock Up/down
movement
Release up/down
movement
Movingthislockinthe"Up"directionlocksthe
bending section at any desired position along the
up/downaxis.Movingthelockintheopposite
direction frees angulation.
4Suctionvalve Thevalveispressedtoactivatesuctiontoremove
anyfluids,debris,orgasfromthepatient.
5Insufflation/rinsingvalve Theholeinthisvalveiscoveredtoinsufflateairand
thevalveisdepressedtofeedwaterforlens
washing.Italsocanbeusedtofeedairforremoving
anyfluidsordebrisadheringtotheobjectivelens.
6Up-Down Control Wheel
R
F
L
D
U
Move bending
section down
Move bending
section up
Whenthiswheelisturnedinthe“U”direction,the
bendingsectionmovesUP;whenthewheelisturned
inthe“D”direction,thebendingsectionmoves
DOWN.
7Left-Right Control Wheel
R
F
L
D
U
Move bending
section left
Move bending
section right
Whenthiswheelisturnedinthe“R”direction,the
bendingsectionmovesRIGHT;whenthewheelis
turnedinthe“L”direction,thebendingsection
movesLEFT.
8Left-RightLockLever
R
F
L
D
U
Lock right/left
movement
Release right/left
movement
Turningthislockinthe“F” direction frees
angulation.Turningthelockintheoppositedirection
locksthebendingsectionatanydesiredposition
along the left/right axis.
9Biopsyvalve Biopsy access cap. Seals the instrument channel.
11

10 Instrument channel Theinstrumentchannelfunctions:
• Channel for the insertion of endoscopic
accessories
• Suction channel
• Fluidfeedchannel(fromasyringeviathe
biopsyvalve)
11 Insertionlimitmark Thismarkindicatesthemaximumpointtowhichthe
endoscopemaybeinsertedintothepatient´sbody.
12 Insertion tube Flexible insertion tube
13 Bending section WhentheUp-DownandRight-Leftleversare
operated,thedistalendoftheendoscopeis
deflected.
14 Distal end Containsthecamera,LEDs,theworkingchannelexit
andtheelevator.
15 Camera Providesliveimagestream.
16 Elevator Theelevatorpositionsendoscopicaccessorieswhen
theelevatorcontrolleverisoperated.
17 Vacuumconnector Connects the endoscope to the suction tube of the
suction pump.
18 Insufflation connector Connects the endoscope to the insufflator.
19 Lot.Number PrintedLot.Numberoftheendoscope
20 Endoscopestrainrelief Snap connector to the aBox™ Duodeno (no electrical
function).
21 Rinsing tubing Thetubingsupplyingsterilewaterforrinsingthe
objectivelens.
22 Process water tubing Insertintotosterilewaterbottletoprovidethe
endoscope with sterile water
23 Endoscopeconnector Connects the endoscope electrically to the aBox™
Duodeno.
3. ExplanaonOfSymbolsUsed
Symbols Indication Symbols Indication
MaxOD
Maximuminseron
poronwidth
(Maximumouter
diameter) MinID
Minimuminstrument
channel width
(Minimuminnerdiameter)
Refer to the
instruction manual
Warning,important
information. Pay attention
to information in
Instructions for use!
130°
Fieldofview Global trade identification
number
12

EN
Symbols Indication Symbols Indication
%
Humiditylimitation:
relativehumidity
between 30 and 85%
in procedural
environment
Atmospheric pressure
limitation:between80and
109kPainprocedural
environment
-5 oC
50
oF
40 oC
10 4 oFTransportation
temperature
Protection against electric
shock-TypeBF,safetlyclass
IEC60601-1
MedicalDevice
Steriledevice,devicewas
sterilizedwithEthylene-
Oxide(EO).
Packaginglevelensures
sterility
DateofManufacture Protectthepackaged
product from moisture
LotNumber,
Batch Code. ReferenceNumber
Steriledevice,device
wassterilizedwith
Ethylene-Oxide(EO).
Packaginglevel
ensuring sterility
Useby,ExpirationDate
Do not use if the
packageisopenedor
damaged
Devicenotforreuse
Workinglength
124cm / 48.8" of the
aScope™ Duodeno
RxOnly PrescriponDevice
4. PreparaonsForUse
Numbers in gray circles below refer to illustraons on page 2. Before each procedure, prepare
andinspect anew instrument as instructedbelow.Inspect otherequipmentto beused withthis
instrumentasinstructedintheirrespecveinstruconmanuals.Shouldanyirregularitybeobserved
aerinspecon,followtheinstruconsasdescribedinsecon8,“Troubleshoong”.Ifthisinstru-
mentmalfuncons,donotuseit.ContactyourAmbusalesrepresentaveforfurtherassistance.
4.1 PreparaonAndInspeconOfTheaScope™Duodeno
InspeconoftheEndoscope 1
• Checkthatthepouchsealisintact.
• CarefullypeelofthepeelpouchpackagingoftheaScope™Duodenopackagingandremove
theprotecveelementsfromthehandleandthedistalend.
1a
1b
13

• Carefullyrunyourhandbackandforthovertheenrelengthoftheinserontube,including
thebendingseconanddistalend,oftheaScope™Duodenotomakesurethatthereare
noimpuriesordamageontheproductsuchasroughsurfaces,sharpedgesorprotrusi-
onswhichmayharmthepaent.Makesuretouseasepctechniquewhenperformingthe
above.Otherwisethesterilityoftheproductwillbecompromised.
• Inspect the distalendof theendoscope´sinseronseconforscratches,cracks orother
irregularies.
• TurntheUp-DownandRight-Lecontrolwheelsineachdireconunlitstopsandreturn
toneutralposion.Conrmthatthebendingseconfunconssmoothlyandcorrectly,that
maximumangulaonisachievedandreturnedtotheneutralposion.
• Operatetheelevatorcontrollevertoconrmthattheelevatorcanbeoperatedsmoothly
andcorrectlyandreturntotheneutralposion.
• Conrm that the angulaon locks are funconal by locking and releasing the angulaon
locksaccording to secon 2.3.Turntheangulaon wheelsfullyin all direcons,lock the
angulaonin a fully angulatedposionandconrmthatthebending secon can besta-
bilized.Releasetheangulaonlocksandconrmthatthebendingseconstraightensout.
• Conrmthatthetopholeoftheinsuaon/rinsingvalveisnotblocked.
• Usingasyringeinsertsterilewaterintotheintrumentchannel.Presstheplunger,ensure
thattherearenoleaksandthatthewaterisemiedfromthedistalend.
• Ifapplicable,conrmcompabilitywithapplicableaccessorydevicesasappropriate.
4.2 PreparaonOfTheEndoscope
PrepareandinspectaBox™Duodeno,medicalgrademonitor,suconpump,andinsuatoras
describedintheirrespecvemanuals.
• Prepareaboleofsterilewaterandplaceitinthedesignedboleholderlocatedonthe
front(leside)oftheaBox™Duodeno.Forlenswashingwateritisrecommendedthatthe
sterilewaterbolechosenshouldcontainaminimumof1000mlinvolume.Pleasenote
thatanewboleofsterilewatershouldbeusedatthestartofeachprocedure.
• PoweruptheaBox™Duodeno.OncetheaBox™Duodenohasbeensetandpoweredup,
theSystemindicateswhenitisreadybydisplayingtheinformaonandsengsmenu-
whichincludestheinformaonmessage:“pleaseconnectendoscope”.
FordetailedinformaonaboutPoweringuptheaBox™DuodenopleaserefertotheIFUofthe
aBox™ Duodeno.
• Slide the endoscope strain relief into the aBox™ Duodeno connector snap.
• OpenthehousingoftheperistalcpumplocatedonthefrontpaneloftheaBox™
Duodenobygentlypushingupwithyourthumb(s)unlthetopoftheperistalcpumpis
exposed.
• Carefully place the rinsing tubing of the aScope™ Duodeno around the roller of the
peristalcpumpmakingsurethetubingisnottwisted.Therinsingtubingshouldcoverthe
roller of the pump and go underneath the roller pump.
• Closetheperistalcpumpbypressingthehousingdownunlthetopoftheperistalc
pumpisclosed.Makesurethattherinsingtubingisnestledwithinthenotchesoneach
side of the roller before closing completely.
• Removeallsealcaps/coversfromtheboleofsterilewater.Insertthewatertubinginto
theboleofsterilewater.Ensurethattheendofthetubingreachestotheboomofthe
waterbolesothatthemaximumvolumeofwatercanbesuconedfromthewaterbole
prior to replacing (as necessary) to reduce waste.
4.3 AachingAncillaryEquipmentToTheEndoscope
TheaScope™ Duodeno is designed towork withmostreadily available and most oenulized
medicalsuconanduidmanagementsystems.
Irrespecveofthechosen uid management system,overowprotecon mustbeafeatureof
the suconcanisterassemblyulized inordertoprevent uidsfrom enteringthesystem.This
featureiscommonlyreferredtoas"self-sealing"featureora"shut-o-lter",orsimilarmecha-
nism.Pleasenotethatanewsuconcanisterandconneconshouldbeusedforeachprocedure.
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The aScope™ Duodeno does not itself produce negave pressure and therefore an external
vacuumsource(e.g.wallsuconormedicalgradesuconpump)willberequiredtooperatethe
system. Standardsucontubingswith anominaldiameter should besucient,aslongas they
simplyandsecurelytoverthestandardsizesuconconnectoroftheaScope™Duodeno.
Nomenclatureusedinthisseconfollowstheestablishedconvenonthateachcanisterulized
willhavemulpleconneconportslabelledeither"ToVacuum"or"ToPaent".However,itisthe
responsibilityoftheusertofollowallmanufacturerinstruconsandguidanceapplicabletothe
endoscopicuidmanagementsystemchosenfortheusewiththeaScope™Duodeno.
ConnecontotheFluidCanister
To perform paent examinaons or procedures, all uid containers (e.g. sterile water bole)
m u s t  b e  p r o p e r l y  a n d  s e c u r e l y  c o n n e c t e d  t o  t h e  a B o x ™  D u o d e n o  t o  p r e v e n t  s p i l l a g e ,  t h e r e b y 
maintainingasafeworkenvironment.Placethecontainersinthedesignatedlocaonsandconnect
themaccordingtotheinstruconsinthischapter.Pleasenotethatanewsuconcanister/sterile
waterbolemustbeusedforeachprocedure.
CO₂Connecon/ConnecngtheInsuator
TheaScope™DuodenoisdesignedtoworkwithasourceofmedicalgradeCO₂forinsuaon.The
maximummedicalgradeCO₂supplypressureis12psi(80kPa).ConnecttotheaScope™Duodeno
usingatubewithaluer-lockconnector.
• IfancillaryequipmentisONturnOFF
• Connect the luer-lock of the insuaon tubing from the insuator to the insuaon
connector of the aScope™ Duodeno.
• TurntheancillaryequipmentbackON
ConnecontotheSuconSystem
Regardlessofthevacuumsourcechosen,theaScope™Duodenowillrequirethesourcetoprovide
avacuumofmin.-7psi(-50kPa)andmax.-11psi(-76kPa)fortheendoscopetooperatenormally.
Failure to provide the minimum vacuum requirements could result in a decreased capacity in
removingpaentwasteand/orirrigaonuidandlossofthecoolingfuncon.
• IfancillaryequipmentisONturnOFF
• Fittheendofthesucontubingsecurelyoverthesuconconnectorlocatedontheendo-
scope connector of the aScope™ Duodeno.
• Connecttheother end ofthesucontubingfrom the sucon connector oftheaScope™
Duodenototheexternalsuconsystem(e.g.wallsuconormedicalsuconpump).
• TurntheancillaryequipmentbackON
ElectricalConnecontotheaBox™Duodeno
• Makesureallconneconsabovehavebeencompleted,theancillarydevicesandtheaBox™
Duodeno has been set and powered up.
• TheaBox™Duodenoindicateswhenitisreadybydisplayingtheinformaonmessageon
the main monitor screen: “please connect endoscope”. For detailed informaon about
seng-uptheaBox™DuodenopleaserefertotheIFUofthespecicdevice.
• L i   t h e  e n d o s c o p e  c o n n e c t o r  c o v e r  o n  t h e  a B o x ™  D u o d e n o  a n d  p l u g  t h e  e n d o s c o p e 
connectorintotheconnectorsocketoftheaBox™Duodeno.
• Thesystemwillaskyoursttoconrmthatanewboleofsterilewaterwaspreparedfor
the procedure.
• Onceconrmedthesystemwilldisplaytheliveprocedureimage.Fordetailedinformaon
aboutusingtheaBox™DuodenopleaserefertotheIFUofthespecicdevice.
ThelightmussbeturnedONbytheuser.FordetailedinformaonaboutusingtheaBox™Duodeno
please refer to the IFU of the aBox™ Duodeno.
InspeconoftheImage
• TurnontheLED´sbypressingthelightsourcebuonontheaBox™Duodeno.
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• Verify that a live video image appears on the screen by poinng the distal end of the
aScope™Duodenotowardsanobject,e.g.thepalmofyourhandandmakesurethatthe
orientaonoftheimageiscorrect.
• Adjusttheimagepreferencesifnecessary,byaccessingthesengsandinformaonmenu
oftheaBox™Duodeno.FordetailedinformaonpleaserefertotheaBox™DuodenoIFU.
• Angulatetheendoscopedistalendandconrmtherearenodisruponstotheliveimage,
norarethereanyotherirregulariesornotedarfacts.
• Iftheimageisimpairedand/orunclear,wipethelensatthedistalendusingasterilecloth.
CheckoftheRemoteSwitches
Allremoteswitchesshouldbecheckedtoworknormallyeveniftheyarenotexpectedtobeused.
Theendoscopicimagemayfreezeorotherirregulariesmayoccurduringexaminaonandmay
causepaentinjury,bleeding,and/orperforaon.
• Presseveryremoteswitchandconrmthatthespeciedfunconsworkasexpected.
Checkingtheendoscope'ssucon,rinsingandinsuaonfunconality
• Check that the sucon and insuaon/rinsing valve work as expected by pressing the
suconandrinsingvalve.Covertheopeningoftheinsuaonvalveandconrmthatthe
correspondingfunconworksproperly.
4.4 OperangTheaScope™Duodeno
InseronoftheEndoscope 9
• Insertasuitablemouthpieceandplaceitbetweenthepaent'steethorgums.
• Makesuretheelevatorisnotraisedbeforeyouinserttheendoscope.
• Ifnecessary,applyamedical-gradelubricanttotheinseronsecon.
• Insertthedistalendoftheendoscopethroughtheopeningofthemouthpiece,thenfrom
themouthtothepharynxwhileviewingtheendoscopicimage.Donotinserttheinseron
seconintothemouthbeyondtheinseronseconlimitmark.
Holdinganmanipulangtheendoscope
• Thecontrolseconoftheendoscopeisdesignedtobeheldinthelehand.
• Theinsuaon/rinsingandsuconvalvescanbeoperatedusingtheleindexnger.
• The UP/DOWN angulaon control wheel and the elevator control lever can be operated
usingthelethumbofthelehand.
• TherighthandisfreetomanipulatetheinseronseconandtheRIGHT/LEFTangulaon
control wheel.
AngulaonoftheDistalEnd
• Operate the angulaoncontrol wheelsas necessarytoguide thedistal end for inseron
andobservaon.
• The endoscope’s angulaon locking levers are used to hold the angulated distal end in
posion.
Insuaon/Rinsing
• Cover the insuaon/rinsing valve’s hole to feed air from the insuaon/rinsing valves
atthedistalend.Presstheinsuaon/rinsingvalvetofeedwaterontotheobjecvelens.
InsllaonofFluids
• Fluidscanbeinslledthroughtheworkingchannelbyinserngasyringeintotheworking
channel port of the aScope™ Duodeno. Insert the syringe completely into the working
channelportandpresstheplungertoinslluid.
• Makesureyoudonotapplysuconduringthisprocess,asthiswilldirecttheinslleduids
intothesuconcolleconsystem.Toensurethat alluids haslethechannel,ushthe
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channel with ca. 5 seconds of air.
Sucon
• Pressthesuconvalvetoaspirateexcessuidsorotherdebrisobscuringtheendoscopic
image.
• For opmal sucon capability it is recommended to remove accessories enrely during
sucon.
InseronofEndoscopicAccessories
Always make sure to select the correct size endoscopic accessory for the aScope™ Duodeno.
Inspect theendoscopicaccessory beforeusingit. If thereisanyirregularityin its operaonor
externalappearance,replaceit.Inserttheendoscopicaccessoryintotheinstrumentchannelport
andadvanceitcarefullythroughtheworkingchannelunlitcanbeseenonthemonitor.
• Select the endoscopic accessories compable with the aScope™ Duodeno. Refer to the
accessoriesinstruconmanualsforoperanginstrucons.
• Raisetheelevatorbymovingtheelevatorcontrolleverinthe“Up”direcon.
• HoldtheUP/DOWNandRIGHT/LEFTangulaonwheelsstaonary.
• Conrmthatthepoftheendoscopicaccessoryisclosedorretractedintoitssheathand
inserttheendoscopicaccessoryslowlyandstraightintothebiopsyvalve.
• Holdtheendoscopicaccessoryapproximately4cmfromthebiopsyvalveandadvanceit
slowlyandstraightintothebiopsyvalveusingshortstrokeswhileobservingtheendoscopic
image.Conrmthatthepoftheendoscopicaccessorycontactstheelevator.
• Movetheelevatorcontrolleverintheoppositedireconofthe"Up"direcontolowerthe
elevator.Advancetheendoscopicaccessoryslightlyandmovetheelevatorcontrolleverin
the“Up”direcon.Conrmthattheaccessoryappearsintheendoscopicimage.
• Manipulatetheelevatorcontrollevertoadjusttheheightoftheelevator.
WithdrawalofEndoscopicAccessories
• Closethepoftheendoscopicaccessoryand/orretractitintoitsshealth.
• Whileloweringtheelevatorgradually,slowlywithdrawtheendoscopicaccessory.
WithdrawaloftheEndoscope
• Stopusingtheimagemagnicaon(zoom)funconoftheaBox™Duodeno.
• Movetheelevatorcontrolleverintheoppositedireconofthe"Up"direconunlitstops.
• Aspirateaccumulatedair,blood,mucusorotherdebrisbydepressingthesuconvalve.
• MovetheUp/Downlockinglevertothe"Down"direcontoreleasetheangulaon.
• TurntheLe/Rightlockinglevertothe“F”direcontoreleasetheangulaon.
• Carefully withdraw the endoscope while observing the endoscopic image. Remove
mouthpiecefromthepaent´smouth.
5. EndingAProcedure
5.1 ConcludingAPaentProcedure
• Disconnect the endoscope connector from the aBox™ Duodeno.
• Opentherollerpumphousingandremovetherinsingtubing.
• Removetheprocesswatertubingandtheboleofsterilewaterfromtheboleholderon
the aBox™ Duodeno.
• Discardthesterilewaterbole.
• TurnOFFtheinsuatororCO₂sourceanddisconnectthetubingfromtheaScope™Duodeno.
• TurnOFFthevacuumsource/pumpanddisconnectthetubingfromtheaScope™Duodeno.
6. AerUse
• Checkifthereareanymissingparts,evidenceofdamage,cuts,holes,sagging,orotherirre-
gulariesonthebendingsecon,distalend,orinseronoftheaScope™Duodeno.Should
10
17

anyirregulariesexist,immediatelydetermineifanypartsaremissingandtaketheneces-
sarycorrecveacon(s).
• Disconnect the endoscope strain relief from the aBox™ Duodeno.
• Discard the endoscope. 13
IncaseofanyadverseeventspleasecontactthemanufacturerofthedeviceoryourlocalAmbu
distributor.InEuropetherelevantcountryhealthagencyorauthorityshouldalsobeinformed.
ReturningDevicestoAmbu
ShoulditbenecessarytosendanaScope™DuodenotoAmbuforevaluaon,pleaseinformyour
representaveat Ambubeforehandfor instruconsand/orguidance.Topreventinfecon,itis
strictlyforbiddentoshipcontaminatedmedicaldevices.ThemedicaldeviceaScope™ Duodeno
must be decontaminated on site before shipment to Ambu. Ambu reserve the right to return
contaminatedmedicaldevicestothesender.
Disposal of the aScope™ Duodeno
TheSingle-UseaScope™Duodenoisconsideredmedicalwasteafteruseandmustbedisposedof
inaccordancewithlocalguidelinesformedicalwastewithelectroniccomponents.Thisisasingle-
usedevice,sodonotsoak,rinseorsterilizeasitmayleaveharmfulresiduesorcausemalfunction
ofthedevice.Thedesignandmaterialusedarenotcompatiblewithconventionalcleaningand
sterilizationprocedures.
7. Technical Data
Allthefollowingreportedmeasurements(e.g.weight,dimensions)areaveragevalues.Therefore,
smallvariaonsmayoccur,whichhoweverwillhavenoeectontheperformanceand/orsafety
of the system.
7.1 aScope™ Duodeno
EndoscopeFuncons
TotalLength 3100 mm
Inseronsecon Workinglength 1240 mm
Inserontubeouterdiameter 11.3 mm
Distal end outer diameter 13.7 mm
Bendingsecon Angulaon 120° Up
90° Down
90°Le
110° Right
Illuminaonmethod LED
OpcalSystem Fieldofview
Direconofview
130°
Backwardsideviewing6°
Workingchannelinnerdiameter Ø 12.6 Fr (4.2 mm)
7.2 StorageAndOperaonEnvironmentSpecicaons
Transportaontemperature -5 - 40°C (41 - 104°F)
Storage temperature 10°C - 25°C
Operaontemperature 10°C - 40°C
Relavehumiditytransportaon,storageand
operaon
30-85%relave
Atmospheric pressure 80-109kPa(100kPa=1Bar)11.6-15.8psi
600-818mmHg
11
12
18

EN
7.3 ListOfAncillaryEquipment
AncillaryEquipment Informaon Part of the System
Rinsing Water Sterilewateravailablein
clinicalenvironment,upto
1000mlboles.Boleswith
punch-trough hole in lid are
recommended)
No
BoleHolder Holderforboleofsterile
water
Yes
Suconcanister Medicalgradevacuum
suconcanister(e.g.
Medela);anymarketed
canister can be used
No
VacuumSource Eithervacuum/suconpump
orvacuumfromthewallwith
atleast-7psi(50kPa)and
max.-11psi(-76kPa)
No
Insuator Insuaonsource.Max.
12psi(80kPa).
No
7.4 Accessories
GeneralInformaon Endoscopicdevicesshouldhaveamaximum
diameter of 4 mm and must be type BF or CF.
Endoscopicaccessoriesshuldnothaveanysharp
edges or corners.
Connectedequipment,especiallyelectrical
equipment,mustconformtorelevantmedical
standards (medical grade).
Thereisnoguaranteethatinstrumentsselected
onlyonthebasisoftheworkingchanneldiameter
willfunconincombinaonwiththesystem.For
informaonregardinginstrumentscompability
pleasecontactyourAmbusalesrepresentave.
8. Troubleshoong
Thefollowingtableshowsthepossiblecausesofandcountermeasuresagainsttroublesthatmay
occurduetoequipmentsengerrorsordeterioraonofconsumable.Troublesorfailuredueto
othercausesthanthoselistedbelowshouldbereportedtoAmbuA/S.Makesuretocontactyour
Ambusalesrepresentavefordetailedinformaon.
8.1 Angulaon,BendingAndLockingLevers
Possible Problem Possible Cause Soluon
Increased resistance during
angulaoncontrolwheel
operaon
Thelockingleverisengaged Releasethelockinglever
Loosebrakeinaracted
mode
Brakeisnotcorrect
aracted
Checkifthecorrectbrakeis
aractedandifit´scorrectly
aracted.
Lockinglevercannotbe
released/bendingsecon
cannot be straightend
aScope™Duodenodefecve Withdraw the aScope™
Duodeno carefully and
connect a new aScope™
Duodeno
19

Possible Problem Possible Cause Soluon
Distal end does not angulate
when control wheel is
operated
aScope™ Duodeno is
defecve
Withdraw the aScope™
Duodeno carefully and
connect a new aScope™
Duodeno
Max.bendinganglescannot
beachieved
aScope™ Duodeno is
defecve
Withdraw the aScope™
Duodeno carefully and
connect a new aScope™
Duodeno
Elevatordoesnotwork
ormovesinarestricted
manner
aScope™ Duodeno is
defecve
Withdraw the aScope™
Duodeno and connect a new
aScope™ Duodeno
Endoscopicaccessory
extends from the distal end
and cannot be withdrawn
Elevatorisraised Lowertheelevator
Bendingseconangulatesin
theoppositedirecon
aScope™ Duodeno is
defecve
Withdraw the aScope™
Duodeno carefully and
connect a new aScope™
Duodeno
8.2 RinsingAndInsuaon
Possible Problem Possible Cause Soluon
Rinsing not possible
Nobolewithsterilewater
connectedorwaterbole
is empty.
Putanewbolewithsterile
waterintheboleholderand
connect it with the aScope™
Duodeno
Rinsing tubing not properly
connected
Connect the rinsing tubing
properly to the aScope™
Duodeno
Rinsingpumpdefecve Pleaseseetroubleshoong
seconoftheaBox™Duodeno
aScope™ Duodeno is
defecve
Withdraw the aScope™
Duodeno and connect a new
aScope™ Duodeno
Insuaontubingcannotbe
connected
Insuaontubingnot
compable
Replacewithcompable
insuaontubing
Insuaontubingis
connected to the incerrect
connector
Connecttheinsuaon
tubing to the right connector
Connuousinsuaon
withoutoperanginsua-
on/rinsingvalve
Insuaon/rinsingvalve
openingisblocked
Withdraw the aScope™
Duodeno carefully and
connect a new aScope™
Duodeno
Insucientinsuaon
Insuatornotcompableor
notproperlyadjusted
Connectcompable
insuator.
Adjustinsuatorsengs
CO₂-Sourceisempty ConnectanewCO₂-Source
Suconisacvated Deacvatesucon
20