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Carefully run your hand back and forth over the entire length of the insertion tube, including 

the bending section and distal end, of the aScope™ Duodeno to make sure that there are 

no impurities or damage on the product such as rough surfaces, sharp edges or protrusi

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ons which may harm the patient. Make sure to use aseptic technique when performing the 

above. Otherwise the sterility of the product will be compromised.  

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Inspect the distal end of the endoscope´s insertion section for scratches, cracks or other 

irregularities.

 

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Turn the Up-Down and Right-Left control wheels in each direction until it stops and return 

to neutral position. Confirm that the bending section functions smoothly and correctly, that 

maximum angulation is achieved and returned to the neutral position.

 

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Operate the elevator control lever to confirm that the elevator can be operated smoothly 

and correctly and return to the neutral position. 

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Confirm that the angulation locks are functional by locking and releasing the angulation 

locks according to section 2.3. Turn the angulation wheels fully in all directions, lock the     

angulation in a fully angulated position and confirm that the bending section can be sta

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bilized. Release the angulation locks and confirm that the bending section straightens out.

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Confirm that the top hole of the insufflation/rinsing valve is not blocked.

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Using a syringe insert sterile water into the intrument channel. Press the plunger, ensure 

that there are no leaks and that the water is emitted from the distal end.

 

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If applicable, confirm compatibility with applicable accessory devices as appropriate. 

4.2 

Preparation Of The Endoscope

Prepare and inspect aBox™ Duodeno, medical grade monitor, suction pump, and insufflator as 

described in their respective manuals.

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Prepare a bottle of sterile water and place it in the designed bottle holder located on the 

front (left side) of the aBox™ Duodeno. For lens washing water it is recommended that the 

sterile water bottle chosen should contain a minimum of 1000 ml in volume. Please note 

that a new bottle of sterile water should be used at the start of each procedure. 

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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 information and settings menu

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which includes the information message: “please connect endoscope”. 

For detailed information about Powering up the aBox™ Duodeno please refer to the IFU of the 

aBox™ Duodeno. 
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Slide the endoscope strain relief into the aBox™ Duodeno connector snap. 

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Open the housing of the peristaltic pump located on the front panel of the aBox™ 

Duodeno by gently pushing up with your thumb(s) until the top of the peristaltic pump is 

exposed. 

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Carefully place the rinsing tubing of the aScope™ Duodeno around the roller of the 

peristaltic pump making sure the tubing is not twisted. The rinsing tubing should cover the 

roller of the pump and go underneath the roller pump. 

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Close the peristaltic pump by pressing the housing down until the top of the peristaltic 

pump is closed. Make sure that the rinsing tubing is nestled within the notches on each 

side of the roller before closing completely. 

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Remove all seal caps/covers from the bottle of sterile water. Insert the water tubing into 

the bottle of sterile water. Ensure that the end of the tubing reaches to the bottom of the 

water bottle so that the maximum volume of water can be suctioned from the water bottle 

prior to replacing (as necessary) to reduce waste.

4.3 

Attaching Ancillary Equipment To The Endoscope

The aScope™ Duodeno is designed to work with most readily available and most often utilized 

medical suction and fluid management systems.
Irrespective of the chosen fluid management system, overflow protection must be a feature of 

the suction canister assembly utilized in order to prevent fluids from entering the system. This 

feature is commonly referred to as "self-sealing" feature or a "shut-off-filter", or similar mecha

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nism. Please note that a new suction canister and connection should be used for each procedure.

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Содержание 482001000

Страница 1: ...For use by trained clinicians physicians only For in hospital use For use with Ambu aBox Duodeno Instruction For Use Ambu aScope Duodeno...

Страница 2: ...b d e a c VAC CO2 b d a c CO2 VAC aBox aBox 1 9 13 8 7 2 4 3 6 5 12 11 10 Ambu is a registered trademark and aScope Duodeno is a trademark of Ambu A S 2...

Страница 3: ...2 Preparation Of The Endoscope 14 4 3 Attaching Ancillary Equipment To The Endoscope 14 4 4 Operating The aScope Duodeno 16 5 Ending A Procedure 17 5 1 Concluding A Patient Procedure 17 6 After Use 1...

Страница 4: ...doscopy and endoscopic treatment that are defined by the hospital s medical administrators or other official institutions such as academic societies on endoscopy follow those standards If there are no...

Страница 5: ...that fit 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 Preparation for Use Before endoscopy remove any metall...

Страница 6: ...water level in the water bottle is too low replace the bottle with a new one An empty bottle can cause loss of rinsing and cooling function Always keep a new bottle of sterile water ready for this ca...

Страница 7: ...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...

Страница 8: ...instrument cannot be extended move the elevator control lever in the opposite direction of the Up direction to lower the elevator When the device is used with energized endoscopic devices leakage cur...

Страница 9: ...t The lens surface of the distal end is fragile and visual distortion may occur Do not coil the insertion tube or the umbilicus in a diameter of less than 12 cm Equipment damage can result Do not atte...

Страница 10: ...no is not available in all countries For detailed information please contact your local sales office 2 3 aScope Duodeno Description And Function The aScope Duodeno is a flexible endoscope with side vi...

Страница 11: ...move any fluids debris or gas from the patient 5 Insufflation 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...

Страница 12: ...r 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 stra...

Страница 13: ...d or damaged Device not for reuse Working length 124cm 48 8 of the aScope Duodeno Rx Only Prescription Device 4 Preparations For Use Numbers in gray circles below refer to illustrations on page 2 Befo...

Страница 14: ...that the sterile water bottle chosen should contain a minimum of 1000 ml in volume Please note that a new bottle of sterile water should be used at the start of each procedure Power up the aBox Duoden...

Страница 15: ...quipment back ON Connection to the Suction 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 en...

Страница 16: ...e you insert the endoscope If necessary apply a medical grade lubricant to the insertion section Insert the distal end of the endoscope through the opening of the mouthpiece then from the mouth to the...

Страница 17: ...vance the endoscopic accessory slightly and move the elevator control lever in the Up direction Confirm that the accessory appears in the endoscopic image Manipulate the elevator control lever to adju...

Страница 18: ...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...

Страница 19: ...nstruments selected only on the basis of the working channel diameter will function in combination with the system For information regarding instruments compatibility please contact your Ambu sales re...

Страница 20: ...terile water connected or water bottle is empty Put a new bottle with sterile water in the bottle holder and connect it with the aScope Duodeno Rinsing tubing not properly connected Connect the rinsin...

Страница 21: ...new vacuum source suction pump Instrument channel blocked Flush sterile water with a syringe through the instru ment channel aScope Duodeno defective Withdraw the aScope Duodeno carefully and connect...

Страница 22: ...a or illumination failure Withdraw the aScope Duodeno and connect a new aScope Duodeno Cooling malfunction Connect a new bottle of sterile water and or insert the process water tubing so that it reach...

Страница 23: ...sted in the accompanying documentation are used The device is intended for use exclusively by trained medical personnel This device can cause radio interference or interference with the opera tion of...

Страница 24: ...idelines Electrostatic dischar ge ESD according to IEC 61000 4 2 8 kV contact discharge 15 kV air discharge 8 kV contact discharge 15 kV air discharge Floors should be wood or concrete or covered with...

Страница 25: ...3 V 3 V m Portable and mobile radio equipment should not be used closer to the unit including cords than the recom mended safety distance calculated according to the formula appropriate to the transmi...

Страница 26: ...cted directly to the public power grid that also supplies buildings used for residen tial purpose provided that the following warning is observed Warning This device is intended only for use by traine...

Страница 27: ...PM aScope Duodeno Rev 5 Manufacturer Ambu A S Baltorpbakken 13 DK 2750 Ballerup Denmark T 45 72 25 20 00 F 45 72 25 20 50 www ambu com...

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