Ambu 482001000 Instructions For Use Manual Download Page 1

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For use by trained clinicians/physicians only.

For in-hospital use.

For use with Ambu® aBox™ Duodeno.

Instruction For Use

Ambu® aScope™ Duodeno

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...