Ambu aScope™ Duodeno Instrucțiuni de utilizare

For use by trained clinicians/physicians only.

For in-hospital use.

For use with Ambu® aBox™ Duodeno.

Instructions for Use

Ambu® aScope™ Duodeno

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Ambu is a registered trademark and aScope™ Duodeno is a trademark of Ambu A/S.

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Contents Page

English (Instruction for use) .............................................................................................................................04

Български (Инструкция за употреба) .......................................................................................................28

Čeština (Návod k použití) ..................................................................................................................................56

Dansk (Brugervejledning) .................................................................................................................................80

Deutsch (Bedienungsanleitung) ....................................................................................................................104

Ελληνικά (Οδηγίες χρήσης)...............................................................................................................................132

Español (Instrucciones de uso)........................................................................................................................160

Eesti (Kasutusjuhend) .........................................................................................................................................186

Suomi (Käyttöohje) ..............................................................................................................................................210

Français (Mode d’emploi) ..................................................................................................................................234

Hrvatski (Upute za upotrebu) ..........................................................................................................................260

Magyar (Használati útmutató) .........................................................................................................................284

Italiano (Istruzioni per l’uso) .............................................................................................................................308

日本語（使用説明書） .......................................................................................................................................334

Lietuviškai (Naudojimo instrukcija) ...............................................................................................................358

Latviski (Lietošanas instrukcija) ......................................................................................................................382

Nederlands (Gebruiksaanwijzing) .................................................................................................................406

Norsk (Bruksanvisning) ......................................................................................................................................432

Polski (Instrukcje użytkowania) ......................................................................................................................456

Português (Instruções de utilização) ............................................................................................................482

Română (Instrucțiuni de utilizare) .................................................................................................................508

Pусский (Инструкция по применению) ....................................................................................................534

Slovenčina (Návod na použitie) ......................................................................................................................564

Slovenščina (Navodila za uporabo) ...............................................................................................................588

Svenska (Bruksanvisning) ..................................................................................................................................612

Türkçe (Kullanma talimatları) ...........................................................................................................................636

(使用说明使用说明) .......................................................................................................................................................660

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1. Important Information – 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

to teach the beginner the proper technique or any medical aspects regarding the use of the

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 care of these medical devices. The IFU may be updated without further notice.

Copies of the latest version are available upon request.

1.1. Intended Use / Indication for Use

The aScope™ Duodeno is designed to be used with the aBox™ Duodeno, endoscopic

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 device for any purpose other than its intended use. Select the endoscope to be used

according to the objective of the intended procedure based on the full understanding of the endoscope’s

specications and functionality as described in this IFU.

1.2. General Information

The device is intended to be used by physicians trained on ERCP procedures. If there are ocial

standards for user qualications to perform endoscopy and endoscopic treatment that are

dened by the hospital´s medical administrators or other ocial institutions, such as academic

societies on endoscopy, follow those standards. If there are no ocial qualication standards,

the operator of this device 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.).

The physician should be capable of safely performing the planned endoscopy and endoscopic

treatment following guidelines set by the academic societies on endoscopy, etc., and

considering the diculty of endoscopy and endoscopic treatment. This manual does not

explain or discuss 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 of the latest valid version of IEC 60601-1). Anybody connecting

additional equipment to medical electrical equipment configures a medical system and is

therefore responsible that the system complies with the requirements for medical electrical

systems. If in doubt, consult your local representative or contact Ambu for support.

1.3. Contraindications

Contraindications for ERCP include the following:

• Patients under 18 years.

• When the risks to patient health or life are judged to outweigh the most favorable

benets of the procedure.

• When adequate patient cooperation or consent cannot be obtained.

• When a perforated viscus is known or suspected.

Additional contraindications could exist for high risk procedures, such as biliary sphincterotomy

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in a patient who is fully anticoagulated or therapeutically dosed anti-platelet agents.

Following conditions may as well contraindicate ERCP and need to be qualied:

• Patient has suered a prior severe allergic reaction to ERCP contrast medium.

• Unstable cardiopulmonary, neurologic or cardiovascular status of the patient.

• Severe uncorrected coagulopathy.

1.4. Clinical Benefits

Single-use application minimises the risk of cross-contamination of the patient.

1.5. Warnings and Cautions

Failure to observe these warnings and cautions may result in patient injury or damage to the

equipment. Ambu is not responsible for any damage to the system or patient injury resulting

from incorrect use.

WARNINGS

Indicate a potentially hazardous situation which, if not avoided, could result in death or

serious injury.

Connection of Devices

• Do not connect non-medical grade devices to the endoscope. Connection of devices

that are not medical grade (IEC 60601 conform) could have negative impact on the

safety of the system. Connect only medical grade equipment to the endoscope. For

detailed information consult the IFU of the aBox™ Duodeno.

Single-Use & Cross-Contamination

• The endoscope described in this IFU is a single-use medical device. Since it is

provided in sterile packaging, it must be properly handled (by using aseptic

technique) and stored to ensure the sterile packaging is not breached prior to use.

• Do not attempt to clean and reuse the aScope™ Duodeno as it is a single-use device

and cannot be reprocessed. Reuse of the product can cause contamination, leading

to infections as well as a malfunction of the device.

• Do not use the aScope™ Duodeno if the product sterilization barrier or its packaging

is damaged.

• A new bottle of sterile water with at least 1.000 ml in volume should be used for each

procedure. Using an opened bottle of water may lead to cross-contamination or infection.

• To guard against dangerous chemicals and potentially infectious material during the

procedure and danger of unintentional diathermy burns, wear personal protective

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.

Preparation for Use

• Before endoscopy, remove any metallic objects (watch, glasses, necklace, etc.) from

the patient. Performing high-frequency cauterization treatment while the patient

is wearing metallic objects may cause burns on the patient in areas around the

metallic objects.

• Using an endoscope that is not functioning properly or is suspected to be defective

may compromise patient or operator safety and could potentially result in severe

equipment damage. Inspect the endoscope for damages prior to use. Check

the functionality of the endoscope prior to use. Be sure to always have another

endoscope available and ready for use to avoid any unnecessary delays due to

equipment failure or malfunction.

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Operator Instructions

• Do not strike, hit, or drop the endoscope’s distal end, insertion tube, bending section,

control section, umbilicus, and/or endoscope connector. Also, do not bend, pull, or

twist the endoscope’s distal end, insertion tube, bending section, control section,

umbilicus, or endoscope connector with excessive force. The endoscope may be

damaged and could cause patient injury, burns, bleeding, and/or perforations. It

could also cause parts of the endoscope to fall o inside the patient.

• Do not stare directly into the distal end of the endoscope and avoid patient eye

contact with the distal end of the endoscope whilst the LEDs are ON. Keep your eyes

away from the distal end when inserting endoscopic accessories as eye injury could

potentially result.

• No modication of this equipment is allowed.

• Do not leave the endoscope illuminated before and after examination. Otherwise,

the LEDs could be directed toward to the opened eyes of the sedated patient and can

cause retina burns.

Ancillary Equipment

• If combinations of ancillary equipment other than those described in this IFU are

used, full responsibility is assumed by the medical treatment facility.

• A defective vacuum pump could lead to loss of cooling and increased temperature at

the tip of the endoscope. Make sure to have another vacuum source available.

Operation of the Endoscope

• Never perform angulation control forcibly or abruptly. Never forcefully pull, twist, or

rotate the angulated bending section. Patient injury, bleeding, and/or perforation

may result. It may also become impossible to straighten the bending section during

an examination. Never operate the bending section, feed air or perform suction,

insert or withdraw the endoscope’s insertion section, or use endoscopic accessories

without viewing the live endoscopic image or when the image is frozen or magnied.

Patient injury, bleeding, and/or perforation may result.

• Never insert, withdraw or operate the insertion section abruptly or with excessive

force. Patient injury, bleeding, and/or perforation may result.

• Never insert or withdraw the endoscope’s insertion section while the bending section

is bent or locked in position. Patient injury, bleeding, and/or perforation

may result.

• Never insert or withdraw the endoscope while the elevator is raised, or when

endoscopic accessory extends from the distal end of the endoscope. Otherwise,

patient injury, bleeding, and/or perforation can result.

• Firmly connect the suction tube to the suction pump and to the suction connector on

the endoscope. If the suction tube is not attached properly, debris may drip from the

tube and can pose an infection control risk, cause equipment damage, and/or reduce

suction capability.

• If the sterile 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 case.

• If blood unexpectedly adheres to the surface of the insertion section of the

withdrawn endoscope, carefully check the condition of the patient.

• Do not use the endoscope if any parts of the endoscope or endoscopic accessory

fall o inside the patient body due to equipment damage or failure. Stop using the

endoscope immediately and retrieve all parts in an appropriate way, otherwise,

serious patient injury may occur.

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Image

Always check whether the image on the screen is a live image or a recorded image and

verify that the orientation of the image is as expected. Do not use this device if the live

image cannot be observed, otherwise, patient injury may occur.

• Always set the intensity of electrosurgical devices to the lowest required value to

avoid image disturbance. Do not increase the level of intensity above the standard

ERCP settings. Always limit the continuous activation time of electrical devices to a

minimum.

• If an abnormal endoscopic image appears or an abnormal function occurs but

quickly corrects itself, the endoscope may have malfunctioned. In this case, consider

abandoning the procedure because the irregularity can occur again, and the

endoscope may not return to its normal condition. Stop the examination immediately

and slowly withdraw the endoscope while viewing the endoscopic image. Otherwise,

patient injury, bleeding, and/or perforation can result.

Over-insufflation & Gas

• Conrm that the top hole of the insuation/rinsing valve is not blocked. If the hole is

blocked, air is fed continuously and patient pain, bleeding, and/or perforation can result.

• Do not inate air or a nonammable gas excessively into the patient. This could cause

gas embolism and/or over-insuation.

• Do not insuate ammable gas into the patient. Otherwise, patient 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 illumination. Therefore, do not leave

the endoscope illuminated before and/or after an examination and always maintain

a suitable distance necessary for adequate viewing while using the minimum level of

illumination for the minimum amount of time. Continued illumination will cause the

distal end of the endoscope to become hot and cause operator and/or patient burns.

• Avoid long periods of contact between the tip 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 heating from the light emitting

part. When withdrawing the endoscope, the distal end should be in the neutral and

non-deected position with the brakes released.

Biopsy Valve

• Before using a syringe to inject liquid through the biopsy valve or when aspirating,

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 suction system, and may leak or spray patient debris or

uids, posing an infection control risk. If the biopsy valve is left uncapped during the

procedure, debris or uids could leak or spray from it, posing an infection control risk.

When the valve is uncapped, place a piece of sterile gauze over it to prevent leakage.

• Patient 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. This can

damage the valve, which can reduce the ecacy of the endoscope’s suction system

and may leak or spray patient debris or uids, posing an infection control risk.

• Do not use the biopsy valve if any irregularities are observed during the inspection.

An irregular, abnormal, or damaged valve can reduce the ecacy of the endoscope’s

suction system, and may leak or spray patient debris or uids, posing an infection

control risk. Replace with a new one if necessary.

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Endoscopic Accessories

• When using endoscopic accessories, make sure the accessory remains visible in the

endoscopic image. If the position of the accessory cannot be seen in the endoscopic

image, serious patient injury and/or equipment damage may occur.

• When inserting 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

section as much as possible. Inserting 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 patient injury.

• Do not insert endoscopic accessories without the elevator being raised. If they are

inserted without the elevator being raised, the accessory cannot be observed in the

endoscopic image and may cause patient injury.

• Check the movement of the endoscopic accessory by slowly operating the elevator

control lever several times to raise the elevator. Otherwise, the endoscopic accessory

may move in unexpected directions, and patient injury, bleeding, and/or perforation

may result.

• Locate the endoscopic accessories as central as possible in the endoscopic image

by adjusting the position of the distal end of the endoscope, particularly while

performing papillotomy. When the distal end of the endoscopic accessory is

positioned in the left or right side of the endoscopic image, and the elevator control

lever is operated, the endoscopic accessory may move abruptly, resulting in patient

injury, bleeding, and/or perforation.

• Do not use excessive force when operating, inserting or withdrawing endoscopic

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 patient injury, bleeding, and/or perforation. Never emit

high-frequency 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 section 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 emitted while the distal end of the endoscopic accessory is not visible or too

close to the distal end of the endoscope, patient injury, bleeding, and/or perforation as

well as equipment damage can result.

• While moving the elevator, do not open or close the distal end of the endoscopic

accessory. This could damage the endoscopic accessory and could cause patient

injury, bleeding, and/or perforation. If the endoscopic accessory cannot be inserted or

withdrawn, the distal end of the endoscopic accessory cannot be opened or closed,

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 current may be

additive. Use only endoscopic devices of type BF or CF. Check the compatibility of the

accessory/endoscopic device before use regarding any criteria for safe use.

Suction

• Avoid aspirating solid matter or thick uids; working channel, suction channel, or

suction valve clogging can occur.

• When aspirating, maintain the suction pressure at the lowest level necessary to

perform the procedure. Excessive suction pressure could cause aspiration of and/or

injury to the mucous membrane. In addition, patient uids could leak or spray from the

biopsy valve, posing an infection control risk.

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CAUTIONS

Indicate 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 preparation, use and storage.

• The aScope™ Duodeno is not intended to be repaired. If defective, the aScope™

Duodeno should be returned to Ambu. For more information please refer to Section 6.

• Electromagnetic interference may occur on this device near equipment marked

with the following symbol or other portable and mobile RF (radio frequency)

communications equipment, such as cellular phones. If electromagnetic interference

occurs, mitigation measures may be necessary, such as reorienting or relocating this

device, or shielding the location.

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.

Prior to Use

• To prevent the patient from biting the endoscope, it is recommended that a

mouthpiece is placed in the patient’s mouth before inserting the endoscope.

• Never use a mouthpiece that is deformed, damaged or shows other irregularities,

otherwise, patient injury and/or equipment damage may occur.

• To prevent the patient from breaking one or more teeth, make sure there are no teeth

that are not permanently capped or no missing teeth, prior to examination.

• To prevent the patient of losing a dental prosthesis, make sure the patient removes it

prior to examination.

• Do not allow the suction canister to ll completely. The suction canister must be

changed after each examination. Using a lled suction canister may lead to loss of the

suction function, loss of cooling or malfunction of the suction pump.

Operating the Endoscope

• Be careful not to damage the insertion tube or distal end when using sharp devices in

combination 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 insertion tube and do not allow it to

strike other objects, as this may result in damage to the equipment. The lens surface

at 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 may result if so.

• Do not attempt to bend the endoscope’s insertion section with excessive force.

Otherwise, the insertion section may be damaged.

• Do not twist or bend the bending section with your hands. Equipment damage

may result if so.

• The endoscope's suction valve and insuation/rinsing valve cannot be removed

from the control section. Pressing, pulling, or twisting them with excessive force can

break the switches and/or cause water leaks.

• The endoscope’s insuation and rinsing valves cannot be removed from the control

section. Pressing, pulling, or twisting them with excessive force can break the

switches and/or valves which will lead to loss of functionality.

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• Do not apply olive oil or products containing petroleum-based lubricants

(e.g. Vaseline®) to the endoscope. These products may cause deterioration of the

endoscope. Use only medical grade lubricants which are free of parans and silicone.

• If remote switches, the suction valve or the insuation/rinsing valve are not returning

to the OFF position after being pressed, gently pull them upwards to return them to

OFF position.

Endoscopic Accessories

• Do not use damaged endoscopic accessories. Should any irregularities be

observed during use, take appropriate measures to avoid patient injury and/or

damage to equipment.

1.6. Adverse events

Potential adverse events in relation to Ambu Duodeno System (not exhaustive): Infection/

inammation (including post-ERCP pancreatitis (PEP), cholangitis, cholecystitis, endocarditis

and sepsis), bleeding, perforation, thermal injuries, stent related adverse events,

cardiopulmonary adverse events, air embolism, anaesthesia related adverse events, nausea,

sore throat, abdominal pain and discomfort.

2. System Description

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 information,

please contact your local sales oce.

2.2. Compatible/Applicable Device

Ambu® aBox™ Duodeno

Reusable device

Part number

485001000US (for US market)

485001000 (for non US markets)

The aBox™ Duodeno is not available in all countries. For detailed information,

please contact your local sales oce.

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2.3. aScope™ Duodeno Description and Function

The aScope™ Duodeno is a exible endoscope with side viewing optics, deectable tip and

an elevator to control the position of inserted accessories. The endoscope tip deection is

controlled via wheels, the deecting can be locked via lock levers. The elevator at the tip can

be controlled via deection control at the control section. Insuation, suction and rinsing

functions can be activated via valves.

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R

F

L

D

U

No. Part Function

1Elevator control lever

R

F

L

D

U

Elevator up

Elevator down

When this lever is moved in the “Up” direction, the

elevator is raised. When the lever is moved in the

opposite direction, the elevator is lowered

2Remote switches

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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 conguration of these

switches are:

• Remote switch 1 for image capture

• Remote switch 2 no setting

• Remote switch 3 no setting

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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 uids, debris, or gas from the patient

5 Insuation /

rinsing valve

When the whole in this valve is covered, air is

insuated. When the valve is pressed, water is

fed for lens rinsing. It can also be used to feed air

for removing any uids or debris adhering to the

objective lens

6 Up-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

7 Left-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

8 Left-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 working channel

10 Working channel The working channel functions:

• Working channel for the insertion of

endoscopic accessories

• Suction channel

• Fluid feed channel

(from a syringe via the biopsy valve)

11 Insertion limit mark Indicates the maximum point to which the

endoscope may be inserted into the patient´s body

12 Insertion tube Flexible insertion tube for navigating to

the duodenum

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13 Bending section When the Up-Down and Right-Left levers are

operated, the distal end of the endoscope is deected

14 Distal end Contains the camera, LEDs, the working channel exit

and the elevator

15 Camera Provides live image stream

16 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 Insuation connector Connects the endoscope to the insuator

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 Supply of sterile water for rinsing the objective lens

22 Process water tubing Provides the endoscope with sterile water from

water bottle

23 Endoscope connector Connects the endoscope electrically to the

aBox™ Duodeno

3. Explanation of Symbols Used

Symbols Indication Symbols Indication

Max OD

Maximum insertion

portion width

(Maximum outer diameter) Min ID

Minimum working

channel width

(Minimum inner diameter)

Refer to Instructions for Use

Warning, important

information. Pay attention

to information in

Instructions for Use!

130°

Field of view Global trade

identication number

%Humidity range Atmospheric

pressure range

-5

oC

23

oF

40 o

C

10 4 oFTransport

temperature range

Protection against electric

shock - Type BF, safety class

IEC60601-1

Medical Device

Sterile device,

device was sterilized with

Ethylene-Oxide (EO)

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Symbols Indication Symbols Indication

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

Refer to

Instructions for Use

Do not use if the package is

opened or damaged Device not for reuse

Working length 124 cm/

48.8" of the aScope™

Duodeno

Rx Only Prescription Device

Legal Manufacturer CE Mark

4. Preparation for Use

Numbers in gray circles below refer to illustrations on page 2. Before each procedure,

prepare and inspect a new endoscope as instructed below. Inspect other equipment to be

used with this endoscope as instructed in their respective instruction manuals. Should any

irregularity be observed after inspection, follow the instructions as described in section 8,

“Troubleshooting”.

If this endoscope malfunctions, do not use it. Contact your Ambu sales representative for

further assistance.

4.1. Preparation and Inspection of the aScope™ Duodeno

Inspection 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 protective elements from the handle and the distal end.

• 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 damages on the endoscope, such as rough surfaces, sharp edges or protrusions

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

above. Otherwise, the sterility of the product will be compromised. 1b

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

irregularities. 1b

• Turn the Up-Down and Right-Left control wheels in each direction until they stop and

return to neutral position. Conrm that the bending section functions smoothly and

correctly, that maximum angulation can be achieved and returned to neutral position. 1c

• Operate the elevator control lever to conrm that the elevator can be operated smoothly

and correctly and can be returned to neutral position. 1d

1a

1b

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• Conrm 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 conrm that the bending section

can be stabilized. Release the angulation locks and conrm that the bending section

straightens out.

• Conrm that the top hole of the insuation/rinsing valve is not blocked. 1e

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

that there are no leaks and that the water is emitted from the distal end. 1e

• If applicable, conrm compatibility with applicable accessory devices as appropriate. 2

4.2. Preparation of the Endoscope

Prepare and inspect aBox™ Duodeno, medical grade monitor, suction pump, and insuator as

described in their respective manuals.

• 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 for each procedure. 3

• 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 settings and information menu

and the following information message: “please connect endoscope”. 4

For detailed information 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. 5a

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

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

pump is exposed.

• 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.

• Close the peristaltic pump by pressing the lid of the housing down until the housing 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.

• Remove all seal caps/covers from the bottle of sterile water. Insert the process 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 uid management systems.

Irrespective of the chosen uid management system, overow protection must be a feature of

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

feature is commonly referred to as "self-sealing" feature or "shut-o-lter", or similar mechanism.

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

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

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

system. Standard suction tubings with a nominal diameter should be sucient, as long as they

simply and securely t over the standard size suction connector of the aScope™ Duodeno.

Nomenclature used in this section follows the established convention that each canister

utilized has 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 uid management system chosen for use with the aScope™ Duodeno.

5b

5c

5d

15

Connection to Fluid Canisters 6

To perform patient examinations or procedures, all uid 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/ Connection to the Insufflation System 6

The aScope™ Duodeno is designed to work with a source of medical grade CO₂ for insuation.

The maximum medical grade CO₂ supply pressure is 12 psi (80 kPa). 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ation tubing from the insuator to the insuation

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 a source to

provide a vacuum of min. -7 psi (-50 kPa) and max. -11 psi (-76 kPa) 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 uid 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

endoscope connector of the aScope™ Duodeno.

• Connect the other end of the suction tubing 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 components as described above have been connected, 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 specic 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 then to conrm that a new bottle of sterile water was prepared

for the procedure.

• Once conrmed the system will display the live procedure image. For detailed information

about using the aBox™ Duodeno, please refer to the IFU of the specic device.

The illumination must 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 by pressing the illumination button on the aBox™ Duodeno.

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

aScope™ Duodeno towards an object, e.g. the palm of your hand and make sure that the

orientation of the image is correct.

• Adjust the image preferences, if necessary, by accessing the settings and information

menu of the aBox™ Duodeno. For detailed information, please refer to the aBox™

Duodeno IFU.

• Angulate the endoscope distal end and conrm there are no disruptions to the live

image, nor are there any other irregularities or noted artifacts.

• If the image is impaired and/or unclear, wipe the lens at the distal end using a sterile cloth.

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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 irregularities may occur during examination

and may cause patient injury, bleeding, and/or perforation.

• Press every remote switch and conrm that the specied functions work as expected.

Check of the endoscope's suction, rinsing and insufflation functionality

• Check that the suction and rinsing/insuation valve work as expected by pressing both

the suction and rinsing/insuation valve. Cover the opening of the rinsing / insuation

valve and conrm that the corresponding function works properly.

4.4. Operating the aScope™ Duodeno

Insertion of the Endoscope 9

• Insert a suitable mouthpiece and place it between the patient'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 insertion section.

• 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

insertion section into the mouth beyond the insertion section limit mark.

Holding and Manipulation of the endoscope

• The control section of the endoscope is designed to be held in the left hand.

• The insuation/rinsing and suction valves can be operated using the left index nger.

• The UP/DOWN angulation control wheel and the elevator control lever can be operated

using the left thumb of the left hand.

• The right hand is free to manipulate the insertion section and the RIGHT/LEFT angulation

control wheel.

Angulation of the Distal End

• Operate the angulation control wheels as necessary to guide the distal end for insertion

and observation.

• The endoscope’s angulation locking levers are used to hold the angulated distal end

in position.

Insufflation/Rinsing

• Cover the insuation/rinsing valve’s hole to feed air from the insuation/rinsing valves

to the distal end. Press the insuation/rinsing valve to feed water onto the objective lens.

Instillation of Fluids

• Fluids can be instilled through the working channel by inserting a uid-lled syringe into

the working channel port of the aScope™ Duodeno. Insert the syringe completely into

the working channel port and press the plunger to instill uid.

• Make sure you do not apply suction during this process, as this will direct the instilled

uids into the suction collection system. To ensure that all uids have left the channel,

ush the channel with ca. 5 seconds of air.

Suction

• Press the suction valve to aspirate excess uids or other debris obscuring

the endoscopic image.

• For optimal suction capability, it is recommended to remove accessories entirely

prior to suction.

Insertion of Endoscopic Accessories

Always make sure to select the correct size endoscopic accessory for the aScope™ Duodeno.

17

Inspect the endoscopic accessory before using it. If there is any irregularity in its operation or

external appearance, replace it. Insert the endoscopic accessory into the working channel port

and advance it carefully through the working channel until it can be seen on the monitor.

• Select the endoscopic accessories compatible with the aScope™ Duodeno. Refer to the

accessories' instruction manuals for operating instructions.

• Raise the elevator by moving the elevator control lever in the “Up” direction.

• Hold the UP/DOWN and RIGHT/LEFT angulation wheels stationary.

• Conrm that the tip 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 tip of the endoscopic accessory contacts the elevator.

• Move the elevator control lever in the opposite direction of the "Up" direction to lower

the elevator. Advance the endoscopic accessory slightly and move the elevator control

lever in the “Up” direction. 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 tip of the endoscopic accessory and/or retract it into its sheath.

• While lowering the elevator gradually, slowly withdraw the endoscopic accessory.

Withdrawal of the Endoscope

• Stop using the image magnication (zoom) function of the aBox™ Duodeno.

• Move the elevator control lever in the opposite direction of the "Up" direction until it stops.

• Aspirate accumulated air, blood, mucus or other debris by depressing the suction valve.

• Move the Up/Down locking lever to the "Down" direction to release the angulation.

• Turn the Left/Right locking lever to the “F” direction to release the angulation.

• Carefully withdraw the endoscope while observing the endoscopic image. Remove the

mouthpiece from the patient´s mouth.

5. Ending a Procedure

5.1. Concluding a Patient 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 bottle of sterile water from the bottle holder

on the aBox™ Duodeno.

• Discard the sterile water bottle.

• 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. After Use

• Check if there are any missing parts, evidence of damage, cuts, holes, sagging, or other

irregularities on the bending section, distal end, or insertion of the aScope™ Duodeno.

Should any irregularities exist, immediately determine if any parts are missing and take

the necessary corrective action(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 evaluation, please inform

your representative at Ambu beforehand for instructions and/or guidance. To prevent

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11

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infection, 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.

In an event of a serious incident, please inform Ambu and the competent authority.

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 variations may occur, which however will have no eect on the performance

and/or safety of the system.

7.1. aScope™ Duodeno

Endoscope Functions

Total Length 3100 mm

Insertion section Working length 1240 mm

Insertion tube outer diameter 11.3 mm

Distal end outer diameter 13.7 mm

Bending section Angulation 120° Up

90° Down

90° Left

110° Right

Illumination method LED

Optical System Field of view

Direction of view

130°

Backward side

viewing 6°

Working channel inner diameter Ø 12.6 Fr (4.2 mm)

7.2. Storage and Operation Environment Specifications

Transportation temperature -5 °C – +40 °C (23 °F – 104 °F)

Storage temperature 10 °C - 25 °C (50 °F - 77 °F)

Operation temperature 10 °C - 40 °C (50 °F - 104°F)

Relative humidity for transportation,

storage and operation

30 % – 85 % relative

Atmospheric pressure 80 kPa – 109 kPa (100 kPa=1 Bar)

11.6 – 15.8 psi

600 – 818 mmHg

19

7.3. List of Ancillary Equipment

Ancillary Equipment Information Part of the System

Rinsing Water Sterile water available in clinical

environment, up to 1000 ml bottles

No

Bottle Holder Holder for bottle of sterile water Yes

Suction Canister Medical grade vacuum suction

canister (e.g. Medela); any

marketed canister can be used

No

Vacuum Source Either vacuum/suction pump or

wall suction with at least -7 psi

(-50 kPa) and max. -11 psi (-76 kPa)

No

Insuator Insuation source

Max. 12psi (80kPa)

No

7.4. Accessories

General Information Endoscopic accessories should have a maximum diameter

of 4 mm and should 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 accessories selected only on

the basis of the working channel diameter will function in

combination with the system. For information regarding

Endoscopic accessory compatibility please contact your

Ambu sales representative.

8. Troubleshooting

The following table shows possible problems, that may occur due to equipment setting

errors or deterioration of consumables, their corresponding possible causes and suggested

measures to solve the problem. Troubles or failures due to other causes than those listed

below should be reported to Ambu A/S. Make sure to contact your Ambu sales representative

for detailed information.

8.1. Angulation, Bending and Locking Levers

Possible Problem Possible Cause Solution

Increased resistance

during angulation control

wheel operation

The lock-lever

is engaged

Release the lock-lever

Loose brake in

attracted mode

Brake is not

correctly attracted

Check if the correct brake is

attracted and if it´s correctly

attracted.

Lock-lever cannot be

released/bending section

cannot be straightened

aScope™ Duodeno

is defective

Withdraw the aScope™ Duodeno

carefully and connect a new

aScope™ Duodeno

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