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Reference Number.

Lot Number, Batch Code.

UL Recognized Component Mark for Canada and the 
United States.

Warning.

4. Use of the endoscope

Numbers in gray circles below refer to illustrations on page 2.

4.1. Preuse check of the endoscope

1.  Check that the pouch seal is intact before opening.  1a
2.   Make sure to remove the protective elements from the handle and from the insertion cord. 

1b

3.   Check that there are no impurities or damage on the product such as rough surfaces, 

sharp edges or protrusions which may harm the patient. 

1c

Refer to the Instruction for Use for the compatible monitor for preparation and inspection of 
the monitor.  2

4.2. Inspection of the Image

1.   Plug in the endoscope into the corresponding connector on the compatible monitor.

Please ensure the colours are identical and be careful to align the arrows.  3

2.   Verify that a live video image appears on the screen by pointing the distal end of the 

endoscope towards an object, e.g. the palm of your hand.  4

3.   Adjust the image preferences on the compatible monitor if necessary (please refer to the 

monitor Instruction for Use).

4.  If the object cannot be seen clearly, clean the tip.

4.3. Preparation of the endoscope

1.   Carefully slide the bending control lever forwards and backwards to bend the bending 

section as much as possible. Then slide the bending lever slowly to its neutral position. 
Confirm that the bending section functions smoothly and correctly and returns to a 
neutral position. 

5a

2.   Using a syringe insert 2ml of sterile water into the working channel port (if applying a 

Luer Lock syringe use the enclosed introducer). Press the plunger, ensure that there are  
no leaks, and that water is emitted from the distal end.  5b

3.   If applicable, prepare the suction equipment according to the supplier’s manual.  5c   

Connect the suctioning tube to the suction connector and press the suction button to 
check that suction is applied.

4.   A pre-check of compatibility of accessories is recommended. If applicable, verify that 

endoscopic accessory of appropriate size can be passed through the working channel 
without resistance. The enclosed introducer can be used to facilitate the insertion of  
soft accessories.  5d

4.4. Operating the endoscope

Holding the endoscope and manipulating the tip  6
The handle of the endoscope can be held in either hand. The hand that is not holding the 
endoscope can be used to advance the insertion cord into the patient’s nose or mouth. Use 
the thumb to move the control lever and the index finger to operate the suction button. The 
control lever is used to flex and extend the tip of the endoscope in the vertical plan. Moving 
the control lever downward will make the tip bend anteriorly (flexion). Moving it upward will 
make the tip bend posteriorly (extension). The insertion cord should be held as straight as 
possible at all times in order to secure an optimal tip bending angle.

8

Summary of Contents for aScope 4 RhinoLaryngo Intervention

Page 1: ...Instruction for Use Ambu aScope 4 RhinoLaryngo Intervention...

Page 2: ...Ambu is a registered trademark and aScope and aView are trademarks of Ambu A S Pat Pending...

Page 3: ...gyar Haszn lati tmutat 92 99 Inglese Istruzioni per l uso 100 107 108 115 Lietuvi naudojimo instrukcija 116 123 Latvie u val Lieto anas instrukcija 124 131 Nederlands Gebruiksaanwijzing 132 139 Norsk...

Page 4: ...atient resulting from incorrect use WARNINGS 1 Only to be used by physicians trained in clinical endoscopic techniques and procedures 2 The endoscope is a single use product and must be handled in a m...

Page 5: ...ertion cord or distal tip Do not allow other objects or sharp devices such as needles to strike the endoscope 3 US federal law restricts these devices for sale only by or on the order of a physician 2...

Page 6: ...tion button Activates suction when pressed down MABS 6 Insertion cord Flexible airway insertion cord PU 7 Bending section Manoeuvrable part PU 8 Distal end Contains the camera light source two LEDs as...

Page 7: ...ng channel width Minimum inner diameter Field of view Do not use if the product sterilisation barrier or its packaging is damaged This product is not made with natural rubber latex 10o C 50o F 40o C 1...

Page 8: ...s neutral position Confirm that the bending section functions smoothly and correctly and returns to a neutral position 5a 2 Using a syringe insert 2ml of sterile water into the working channel port if...

Page 9: ...Insert the endoscopic accessory into the working channel port and advance it carefully through the working channel until it can be seen on the live image on the monitor The enclosed introducer can be...

Page 10: ...85 Atmospheric pressure kPa 80 109 Optical System aScope 4 RhinoLaryngo Intervention Field of View 85 Depth of Field mm 6 50 Illumination method LED Suction connector aScope 4 RhinoLaryngo Interventio...

Page 11: ...cannot be seen clearly clean the tip Absent or reduced suction capability or difficulty in inserting endoscopic accessory through the channel Channel blocked Withdraw the endoscope and clean the work...

Page 12: ...e Benutzung zur ckzuf hren sind WARNHINWEISE 1 Das Produkt darf nur von in der Durchf hrung von klinischen Endoskopie Verfahren geschulten rzten verwendet werden 2 Das Endoskop ist ein Medizinprodukt...

Page 13: ...digen Passen Sie auf dass das Endoskop nicht von anderen Objekten oder scharfen Gegenst nden wie Nadeln besch digt wird 3 Gem US amerikanischem Bundesrecht d rfen diese Ger te lediglich von einem Arz...

Page 14: ...h r verwendet werden PU 4 Absauganschluss Erm glicht den Anschluss eines bsaugschlauchs MABS 5 Absaugtaste Dr cken um die Absaugfunktion zu aktivieren MABS 6 Einf hrungsschlauch Flexibler Teil zur Ein...

Page 15: ...er te Bedeutung Arbeitsl nge des Endoskop Einf hrungsschlauchs Max OD Maximale Breite des Intubationsbereichs maximaler Au endurchmesser Min ID Mindestbreite Arbeitskanal minimaler Innendurchmesser Bl...

Page 16: ...Bildeinstellungen auf dem Monitor an weitere Informationen finden Sie in der Bedienungsanleitung des Monitors 4 Wenn das Objekt nicht deutlich zu erkennen ist reinigen Sie die Spitze 4 3 Vorbereitung...

Page 17: ...ssigkeiten in das Absaugsammelsystem geleitet werden k nnen Um sicherzustellen dass sich keine Fl ssigkeit mehr im Kanal befindet mit 2 ml Luft durchsp len Aspiration 7c Wenn ein Absaugsystem mit dem...

Page 18: ...ndere medizinische Ger te Teil 1 Allgemeine Anforderungen 5 2 Endoskopspezifikationen Intubationsbereich aScope 4 RhinoLaryngo Intervention Biegbare Sektion1 130 130 Durchmesser Einf hrungsschlauch mm...

Page 19: ...m Live Bild auf dem Monitor Schlechte Bildqualit t Blut Speichel o auf der Linse distales Ende Wenn das Objekt nicht deutlich zu erkennen ist reinigen Sie die Spitze Fehlende oder eingeschr nkte Absau...

Page 20: ...bu d cline toute responsabilit en cas d endommagement du dispositif ou de blessure du patient d coulant d une utilisation incorrecte AVERTISSEMENTS 1 Usage r serv aux m decins form s aux proc dures et...

Page 21: ...ns l ventualit 2 d un dysfonctionnement 3 Attention ne pas endommager la gaine d insertion ou l embout distal Ne pas laisser d autres objets ou dispositifs coupants tels que des aiguilles entrer en co...

Page 22: ...cord d une tubulure d aspiration MABS 5 Bouton d aspiration Active l aspiration lorsqu il est actionn MABS 6 Gaine d insertion Gaine d insertion dans les voies a riennes souple PU 7 Section b quillabl...

Page 23: ...male du canal op rateur diam tre int rieur minimal Champ de vision Ne pas utiliser si la barri re de st rilisation ou l emballage sont endommag s Ce produit ne contient pas du latex de caoutchouc natu...

Page 24: ...nt le levier de b quillage en position neutre S assurer que la section b quillable fonctionne correctement et revient en position neutre 5a 2 l aide d une seringue injecter 2 ml d eau st rile dans le...

Page 25: ...remplacer Ins rer l accessoire endoscopique dans le port du canal op rateur et le faire avancer d licatement dans le canal jusqu le voir appara tre sur l image en direct du moniteur L introducteur fou...

Page 26: ...ive 30 85 Pression atmosph rique kPa 80 109 Dispositif optique aScope 4 RhinoLaryngo Intervention Champ de vision 85 Profondeur de champ mm 6 50 M thode d clairage LED Raccord d aspiration aScope 4 Rh...

Page 27: ...aspiration nulle ou limit e ou difficult ins rer l accessoire endoscopique dans le canal Canal obstru Retirer l endoscope et nettoyer le canal op rateur l aide d une brosse de nettoyage ou le rincer e...

Page 28: ...esclusivamente da personale medico esperto addestrato in merito alle procedure e tecniche cliniche di endoscopia 2 L endoscopio un prodotto monouso e deve essere manipolato in conformit con la pratic...

Page 29: ...etti o dispositivi appuntiti quali aghi urtino l endoscopio 3 In base alla legge federale statunitense il presente dispositivo pu essere venduto solo dietro prescrizione medica o da parte di un medico...

Page 30: ...ento di un tubo di aspirazione MABS 5 Pulsante di aspirazione Attiva l aspirazione quando viene premuto MABS 6 Sonda di inserimento Tubo di inserimento endotracheale flessibile PU 7 Sezione curvabile...

Page 31: ...o esterno massimo Min ID Larghezza minima del canale di lavoro diametro interno minimo Campo visivo Non farne uso se la barriera sterile del prodotto o la sua confezione sono danneggiate Il prodotto n...

Page 32: ...pieghevole funzioni senza problemi e correttamente e ritorni agevolmente a una posizione neutra 5a 2 Utilizzando una siringa introdurre 2 ml di acqua sterile nella porta del canale di lavoro se una s...

Page 33: ...no sostituirlo Inserire l accessorio endoscopico nella luce del canale di lavoro e avanzare con attenzione lungo il canale di lavoro fino a che non sar visibile nell immagine in tempo reale sul monito...

Page 34: ...a kPa 80 109 Sistema ottico aScope 4 RhinoLaryngo Intervention Campo visivo 85 Profondit di campo mm 6 50 Metodo di illuminazione LED Connettore di aspirazione aScope 4 RhinoLaryngo Intervention Tubo...

Page 35: ...nta Assente o ridotta capacit di aspirazione o difficolt nell inserimento di un accessorio endoscopico attraverso il canale Canale bloccato Estrarre l endoscopio e pulire il canale di lavoro con una s...

Page 36: ...Ambu A S Baltorpbakken 13 DK 2750 Ballerup Denmark T 45 72 25 20 00 F 45 72 25 20 50 www ambu com 492 512 000 V01 2018 07 TCC 10520...

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