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EN

The  aScope™  Duodeno  does  not  itself  produce  negative  pressure  and  therefore  an  external 

vacuum source (e.g. wall suction or medical grade suction pump) will be required to operate the 

system. Standard suction tubings with a nominal diameter should be sufficient, as long as they 

simply and securely fit over the standard size suction connector of the aScope™ Duodeno.
Nomenclature used in this section follows the established convention that each canister utilized 

will have multiple connection ports labelled either "To Vacuum" or "To Patient". However, it is the 

responsibility of the user to follow all manufacturer instructions and guidance applicable to the 

endoscopic fluid management system chosen for the use with the aScope™ Duodeno.

Connection to the Fluid Canister

To  perform  patient  examinations  or  procedures,  all  fluid  containers  (e.g.  sterile  water  bottle) 

must be properly and securely connected to the aBox™ Duodeno to prevent spillage, thereby                       

maintaining a safe work environment. Place the containers in the designated locations and connect 

them according to the instructions in this chapter. Please note that a new suction canister/sterile 

water bottle must be used for each procedure.

CO₂ Connection/Connecting the Insufflator

The aScope™ Duodeno is designed to work with a source of medical grade CO₂ for insufflation. 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  insufflation  tubing  from  the  insufflator  to  the  insufflation          

connector of the aScope™ Duodeno. 

• 

Turn the ancillary equipment 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 endoscope to operate normally. 

Failure  to  provide  the  minimum  vacuum  requirements  could  result  in  a  decreased  capacity  in 

removing patient waste and/or irrigation fluid and loss of the cooling function. 

• 

If ancillary equipment is ON turn OFF 

• 

Fit the end of the suction tubing securely over the suction connector located on the endo

-

scope connector of the aScope™ Duodeno.

• 

Connect the other end of the suction tubing from the suction connector of the aScope™ 

Duodeno to the external suction system (e.g. wall suction or medical suction pump).

• 

Turn the ancillary equipment back ON

Electrical Connection to the aBox™ Duodeno

 

• 

Make sure all connections 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 information message on 

the  main  monitor  screen:  “please  connect  endoscope”.  For  detailed  information  about 

setting-up the aBox™ Duodeno please refer to the IFU of the specific device.

• 

Lift  the  endoscope  connector  cover  on  the  aBox™  Duodeno  and  plug  the  endoscope                 

connector into the connector socket of the aBox™ Duodeno. 

• 

The system will ask you first to confirm that a new bottle of sterile water was prepared for 

the procedure. 

• 

Once confirmed the system will display the live procedure image. For detailed information 

about using the aBox™ Duodeno please refer to the IFU of the specific device.

The light muss be turned ON by the user. For detailed information about using the aBox™ Duodeno 

please refer to the IFU of the aBox™ Duodeno.

Inspection of the Image

• 

Turn on the LED´s by pressing the lightsource button on the aBox™ Duodeno.

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Summary of Contents for 482001000

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

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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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