Ambu aScope Gastro User manual

For use by trained clinicians/physicians only.
For use in medical facility.
For use with Ambu®aBox™2.
INSTRUCTIONS
FOR USE
Ambu®aScope™Gastro

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QUICK GUIDE
Ambu is a registered trademark and aScope and aBox are trademarks of Ambu A/S.
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Contents Page
English (Instructions for use)...................................................................................................................4-20
Български (Инструкция за употреба)............................................................................................21-40
Čeština (Návod k použití) .......................................................................................................................41-58
Dansk (Brugervejledning) ......................................................................................................................59-75
Deutsch (Bedienungsanleitung) .........................................................................................................76-94
Ελληνικά (Οδηγίες χρήσης)..................................................................................................................95-114
Español (Instrucciones de uso).........................................................................................................115-134
Eesti (Kasutusjuhend) ..........................................................................................................................135-151
Suomi (Käyttöohje)...............................................................................................................................152-169
Français (Mode d’emploi).................................................................................................................. 170-187
Hrvatski (Upute za upotrebu)..........................................................................................................188-205
Magyar (Használati útmutató).........................................................................................................206-223
Italiano (Istruzioni per l’uso)............................................................................................................. 224-241
日 本 語（ 使 用 説 明 書 ） ....................................................................................................................... 242-257
Lietuviškai (Naudojimo instrukcija)...............................................................................................258-275
Latviski (Lietošanas instrukcija) ......................................................................................................276-293
Nederlands (Gebruiksaanwijzing)..................................................................................................294-312
Norsk (Bruksanvisning)....................................................................................................................... 313-329
Polski (Instrukcje użytkowania).......................................................................................................330-347
Português (Instruções de utilização)........................................................................................... 348-365
Română (Instrucțiuni de utilizare) ................................................................................................ 366-383
Pусский (Инструкция по применению)...................................................................................384-404
Slovenčina (Návod na použitie)..................................................................................................... 405-422
Slovenščina (Navodila za uporabo).............................................................................................. 423-440
Svenska (Bruksanvisning)..................................................................................................................441-457
Türkçe (Kullanma talimatları)...........................................................................................................458-475
(使用说明)......................................................................................................................................476-491
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1. Important Information – Read Before Use!
Read the Instructions for Use (IFU) carefully before using the aScope™ Gastro. These
instructions describe the function, set-up and precautions related to operating the
aScopeGastro. Please be aware that these instructions do not describe clinical procedures.
Prior to use of the aScopeGastro, it is important for operators to have received sufficient
training in clinical endoscopic techniques and to be familiar with the intended use,
warnings, cautions, indications and contraindications mentioned in these instructions.
There is no warranty for the aScopeGastro. In this document aScopeGastro refers to
instructions which apply to the endoscope only, while system often refers to information
relevant for the aScopeGastro and the compatible aBox™ 2 displaying unit and accessories.
The Instructions for Use may be updated without further notice. Copies of the current
version are available upon request.
1.1. Intended Use/Indications For Use
The aScopeGastro is a sterile, single-use, flexible gastroscope intended to be used
for endoscopic access to and examination of the upper gastrointestinal anatomy. The
aScopeGastro is intended to provide visualization via a compatible Ambu displaying
unit and to be used with endotherapy accessories and other ancillary equipment.
1.2. Intended Patient Population
The aScopeGastro is intended to be used in adults; this means patients with an age of
18 years or above. The aScopeGastro is used in patients with indications in the upper
gastrointestinal anatomy requiring visualization and/or examination with flexible
gastroscopy and use of endoscopic accessories and/or equipment.
1.3. Contraindications
No known contraindications.
1.4. Clinical Benefits
The aScopeGastro when used with the compatible aBox 2 displaying unit enables
visualization, examination and endoscopic intervention of key anatomical structures in
the upper GI tract, particularly esophagus, gastroesophageal junction, stomach, pylorus,
duodenal bulb and descending duodenum.
High-definition imaging technology will enable endoscopists to view finer mucosal
and vascular details.
The risk of patient cross-contamination is eliminated, as compared to reusable
endoscopes, as the aScopeGastro is a sterile single-use medical device. Also, the risk of
anaphylactic shock associated with exposure to high level disinfectants (as is possible
when using reprocessed scopes) is eliminated.
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1.5. Warnings and Cautions
Warnings
1. For single-use only. Do not reuse, reprocess or resterilize as these processes may
leave harmful residues or cause malfunction of the aScopeGastro. Reuse of the
aScopeGastro may cause cross-contamination potentially leading to infections.
2. Confirm that the outlet of the insufflation/rinsing valve is not blocked.
If theopening is blocked, gas is fed continuously and patient pain, bleeding,
perforation and/or gas embolism can result.
3. Prior to use always perform an inspection and functionality check according to
sections 4.1 and 4.4. Do not use the device if the aScopeGastro or its packaging
is damaged in any way or if the functionality check fails, as this can lead to
patient injury or infection.
4. Patient leakage currents may be additive, when using energised endoscopic
accessories. Do not use energised endoscopic accessories which are not
classified as "type CF" or "type BF" applied part according to IEC 60601, as that
could lead to too high patient leakage current.
5. Do not perform procedures with High Frequency endoscopic accessories if
flammable or explosive gases are present in the gastrointestinal tract as this may
result in serious injury to the patient.
6. Always observe the live endoscopic image when inserting, withdrawing or
operating the aScopeGastro. Failure to do so may result in patient injury,
bleeding and/or perforation.
7. Ensure that the insufflator is not connected to the auxillary water inlet as this
may cause overinsufflation which can result in patient pain, bleeding, perforation
and/or gas embolism.
8. The distal end of the aScopeGastro may get warm due to heating from the LEDs.
Avoid long periods of contact between the distal end of the aScopeGastro and
the mucosal membrane as sustained contact may cause mucosal injury.
9. Do not insert or withdraw the aScopeGastro if endoscopic accessory is protruding
from the distal end of the working channel as this may result in injury to the patient.
10. If the biopsy cap is left uncapped or if the biopsy valve is damaged it can reduce
the efficacy of the aScopeGastro's suction system, and may leak or spray patient
debris or fluids, posing a risk of infection. When the valve is uncapped, place a
piece of sterile gauze over it to prevent leakage.
11. Always use gauze to pull the accessory device through the biopsy valve as
patient debris or fluids may leak or spray, posing a risk of infection.
12. During the procedure always wear personal protective equipment (PPE) to
protect against contact with potentially infectious material. Failure to do so may
cause contamination potentially leading to infections.
13. Using HF (High Frequency) tools/electrosurgical equipment with aScopeGastro
may disturb the image on the displaying unit which may lead to patient injury.
To reduce disturbance try alternative settings on HF generator with lower
Peak Voltage.
14. Portable RF (Radio Frequency) communications equipment (including peripherals
such as antenna cables and external antennas) should be used no closer than
30cm (12 inches) to any part of the aScopeGastro and the displaying unit,
including cables specified by the manufacturer. Otherwise, degradation of the
performance of this equipment could result which could lead to patient injury.

Cautions
1. Only use the aScopeGastro with medical electrical equipment that complies
with IEC 60601-1, and any applicable collateral and particular standards.
Failure to do so may lead to equipment damage.
2. Prior to using any high frequency accessory device, check the compatibility with
the aScopeGastro. Always follow the instructions for use for the third party
device. Failure to do so may lead to equipment damage.
3. Do not activate energized endoscopic accessories before the distal end
of the endoscopic accessory is in the field of view and is extended at an
appropriate distance from the distal end of the endosope as this may result
in aScopeGastro damage.
4. Do not apply oil based lubrication in the working channel as this may increase
friction when inserting instruments.
5. Do not coil the insertion tube or umbilical cord to a diameter of less than 20cm
as this may damage the aScopeGastro.
6. Excessive force – Do not drop, bump, bend, torque or pull any portion of the
aScopeGastro with excessive force as the aScopeGastro may get damaged
leading to failure in functionality.
7. Do not use excessive force to advance the accessory device through the working
channel. Doing so may cause damage to the working channel of the aScopeGastro.
1.6. Potential Adverse Events
Possible complications include (not exhaustive):
•Air embolism
•Gagging
•Gastric-to-pulmonary aspiration
•Mucosal laceration
•Mucosal bleeding
•Perforation
•Peritonitis
1.7. General Notes
If, during the use of this device or as a result of its use, a serious incident has occurred,
please report it to the manufacturer and to your national authority.
2. Endoscope Description
aScopeGastro must be connected to the aBox 2 displaying unit. Please refer to
the aBox 2 Instructions for Use for more set-up details.
2.1. Description of Components
aScopeGastro
Ambu® aScope™ Gastro
Sterile and Single-Use
Gastroscope
Part Number Distal End
Outer Diameter
Working Channel
Inner Diameter
103 cm / 40.6’’
483001000 9.9 mm 2.8 mm
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2.2. Description and Function
The aScopeGastro is a sterile and single-use gastroscope for use within the upper
gastrointestinal tract. The aScopeGastro is inserted into the patient’s upper
gastrointestinal tract through the mouth. The aScopeGastro is powered by connection to
the aBox 2 displaying unit. The aScopeGastro can be used with endotherapy accessories
and ancillary equipment for endoscopic procedures. The working channel allows for the
passage of endoscopic accessories, instillation of fluids, and suction of fluids.
The Water Jet function allows the instillation of fluids. The insufflation function allows
the instillation of CO₂ to expand the gastrointestinal lumen. Insufflation has multiple
purposes hence specification may not be necessary.
The aScopeGastro is intended for left-handed use.
The optical module in the distal tip consists of a camera housing which contains a
camera and LED light sources.
The user can angulate the distal tip in multiple planes for visualization of the upper
gastrointestinal tract by turning the control wheels to activate the bending section
(see figure 1). The bending section can bend up to 210° enabling a retroflexion to
visualize the fundus and esophageal sphincter.
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Figure 1

No. Part Function
Control Section The user holds the aScopeGastro at the control
section with the left hand. The control wheels and
remote switches may be manipulated with the
left and/or right hand.
No. on Fig.1 Part Function
1 Remote
Switches/
Programmable
Buttons
The user activates functions on the aBox 2.
The functions of the remote switch buttons
are pre-configured from factory and can be
re-configured according the user’s preference.
2 Up-Down
Control Wheel
The Up/Down control wheel manipulates the
bending section of the scope. 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.
3 Up/Down
Angulation Lock
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 up/down axis.
4Suction Valve The removable suction valve activates suction
when pressed down. The valve is pressed to
activate suction to remove any fluids, debris or
gas from the patient.
5Insufflation &
Rinsing Valve
The insufflation/rinsing valve controls insufflation
and lens rinsing. Placing a finger on the opening
of the valve activates insufflation. The valve
activates lens washing when pressed down.
6Right-Left
Control Wheel
The Right/Left control wheel manipulates the
bending section of the scope. 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.
7Right/Left
Angulation Lock
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 right/left axis.
8Biopsy Valve Biopsy access valve. Seals the working channel.
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9Working
Channel
The working channel functions as:
•Suction channel.
•Channel for the insertion or connection
of endoscopic accessories.
•Fluid feed channel (from a syringe via
the biopsy valve).
10 Insertion Tube The flexible insertion tube is inserted into the
patient’s upper gastrointestinal tract.
11 Bending Section The bending section is the maneuverable part of
the aScopeGastro, that can be controlled by the
control wheels and angulation locks.
12 Distal Tip The distal tip holds the camera, the light
source (two LEDs), the working channel exit,
the insufflation & rinsing nozzle, and the
Water Jet outlet.
13 Insufflation &
Rinsing Nozzle
Nozzle for lens rinsing & insufflation.
14 Water Jet Outlet Water jet is used for endoscopic irrigation of the
patient’s upper gastrointestinal tract.
15 Working
Channel Outlet
The working channel outlet allows:
•Aspiration of fluids.
•Introduction of endoscopic accessories.
•Introduction of fluids.
16 Camera Enables visualization of the upper
gastrointestinal tract.
17 LEDs Enables illumination of the upper
gastrointestinal tract.
18 Suction
Connector
Connects the aScopeGastro to the suction tube
of the suction pump.
19 Water Jet
Connector
Connects the aScopeGastro to the irrigation tube
of the irrigation pump.
The Water Jet connector has an integrated
one-way valve to reduce the risk of backflow.
20 aScopeGastro
Connector
Connects the aScopeGastro to the output socket
of the aBox 2.
Ancillary equipment for suction, insufflation,
lens rinsing and irrigation can be attached to the
aScopeGastro connector.
21 Insufflation
& Rinsing
Connector
Connects the aScopeGastro to the sterile water
bottle to enable insufflation/lens rinsing.
22 Disconnection
Button
Press the button when disconnecting the
aScopeGastro from the aBox 2.
23 Spare Suction
Valve
Can be used to replace the existing suction valve
in case of blockage.

2.3. Product Compatibility
The aScopeGastro can be used in conjunction with:
•The Ambu aBox 2.
•Insufflator for endoscopic gastrointestinal procedures: source of medical grade CO₂.
•Standard disposable insufflation/rinsing fluid management tubing sets compatible
with Olympus.
•Vacuum source to provide a vacuum.
•Standard suction tubes.
•Gastrointestinal endoscopic instruments specified to be compatible with a working
channel size (ID) of 2.8 mm or less (There is no guarantee that instruments selected using
only this minimum working channel size will be compatible with the aScopeGastro).
•Medical-grade water-based lubricants, iodine based contrast agents, lipiodol,
haemostatic agents, lifting agents, antifoaming agents, tattoo for permanent
staining, and dyes for vital staining.
•Sterile water.
•High frequency electrosurgical equipment fulfilling EN 60601-2-2. To keep high
frequency leakage currents within allowed limits, the maximum sinus peak voltage
level of the electrosurgical unit shall not exceed 5.0 kVp.
•Irrigation pump for endoscopic gastrointestinal procedures with luer connector.
3. Explanation of Symbols Used
Symbol Description Symbol Description
103 cm / 40.6’’
Working length
of the insertion tube. Rx only
US Federal Law restricts
this device to sale by or on
the order of a physician.
Maximum insertion
portion width (Maximum
outer diameter).
Atmospheric pressure
limitation: Between 80
and 106kPa in operating
environment.
Minimum working
channel width (Minimum
inner diameter).
%
Humidity limitation:
Relative humidity
between 30 and 85 % in
operating environment.
Country of manufacturer:
Made in Malaysia Temperature limit.
Field of view. Medical Device.
Warning. Packaging level
ensuring sterility.
Do not use if package
is damaged.
Global Trade
Item Number.
IFU symbol.
UL Recognized
Component Mark
for Canada and
the United States.
The complete list of symbol descriptions can be found on ambu.com.
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4. Use of the aScopeGastro
The number in grey circles refer to the Quick Guide on page 2. Before each procedure,
prepare and inspect a new aScopeGastro as instructed below. Inspect other equipment
to be used with this aScopeGastro as instructed in their respective instruction manuals.
Should any irregularity be observed after inspection, follow the instructions as described
in section 6, "Trouble Shooting". If the aScopeGastro malfunctions, do not use it. Contact
your Ambu sales representative for further assistance.
4.1. Inspection of the aScopeGastro 1
•Check that the pouch seal is intact and discard the aScopeGastro if the sterile seal has
been damaged. 1a
•Carefully peel off the peel pouch packaging of the aScopeGastro and remove the
protective elements from the handle and the distal end. 1b
•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Gastro to make sure that
there are no impurities or damage on the product such as rough surfaces, sharp edges
or protrusions which may harm the patient. Make sure to use aseptic technique when
performing the above. Otherwise the sterility of the product will be compromised. 1c
•Inspect the distal end of the aScopeGastro´s insertion tube for scratches, cracks or
other irregularities. 1c
•Confirm that the top hole of the Insufflation/Rinsing valve is not blocked. 1c
•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. 1d
•Confirm that the angulation locks are functional by locking and releasing the
angulation locks according to section 2.2. Turn the angulation wheels fully in all
directions, lock the angulation in a fully angulated position and confirm that the
bending section can be stabilized. Release the angulation locks and confirm that the
bending section straightens out.
•Using a syringe, flush sterile water into the working channel. Ensure that there are no
leaks and that the water is emitted from the distal end. 1e
•If applicable, confirm compatibility with applicable accessory devices.
•A spare suction valve is available and placed securely on the mounting card together
with the aScopeGastro.
•A new aScopeGastro should be readily available so the procedure can be continued
in case a malfunction should occur.
4.2. Preparations for Use
Prepare and inspect aBox 2, water container, suction and irrigation pumps, and CO₂
insufflator as described in their respective instruction manuals.
•Power up the aBox 2 2. Carefully align the arrows on the connector of the
aScopeGastro cable with the port of the aBox 2 to prevent damage to the
connectors. 3
•Connect the aScopeGastro to the aBox 2 by plugging the aScopeGastro connector
into the corresponding aBox 2 female connector.
•Check that the aScopeGastro has been firmly locked to the aBox 2.
•When using the aScopeGastro it is recommended to use a mouthpiece to prevent
the patient from accidentally biting the insertion tube.
4.3. Attaching Ancillary Equipment
The aScopeGastro is designed to work with most commonly available 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
mechanism. Please note that a new suction canister and connection should be used for
each new procedure.
The aScopeGastro 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Gastro.
Nomenclature used in this section follows the established convention that each canister
utilized will have multiple connection ports labeled either "To Vacuum" or "To Patient".
However, it is the responsibility of the user to follow all third party manufacturer
instructions and guidance applicable to the endoscopic fluid management system
chosen for use with the aScopeGastro.
When using third party devices with the aScopeGastro always consult the instructions
for use accompanying the third party device.
Connection to the Insufflation/Rinsing System 4
The aScopeGastro is designed to work with a source of medical grade CO₂ for insufflation.
Connect the aScopeGastro using a standard disposable insufflation/rinsing fluid
management tubing set.
To perform patient examinations or procedures, all fluid containers (e.g. sterile water
bottle) must be properly and securely placed in order to prevent spillage, thereby
maintaining a safe working environment. Place the containers in the designated
locations and connect them according to the instructions in this section. Please note
that a new suction canister/sterile water bottle must be used for each new procedure.
•If ancillary equipment is ON turn OFF.
•Connect the fluid container’s connection adapter to the aScopeGastro.
•Confirm that the fluid container’s connection adapter fits properly and that it cannot
be rotated.
•Turn the ancillary equipment back ON.
Connection to the Suction System 5
Regardless of the vacuum source chosen, the aScopeGastro will require the source to
provide a vacuum for the aScopeGastro to operate normally. Failure to provide the
minimum vacuum requirements could result in a decreased capacity in removing patient
waste and/or irrigation fluid.
•If ancillary equipment is ON turn OFF.
•Fit the end of the suction tubing securely over the suction connector located on the
aScopeGastro connector.
•Connect the other end of the suction tubing from the suction connector of the
aScopeGastro to the external suction system (e.g. wall suction or medical suction pump).
•Turn the ancillary equipment back ON.
Connection to the Auxiliary Water Jet System 5
•The aScopeGastro has a Auxiliary Water Jet connector with an integrated one-way
valve to reduce the risk of backflow.
•If ancillary equipment is ON turn OFF.
•Just connect the Auxiliary water tubing to the auxiliary water inlet located on the
aScopeGastro connector.
•Confirm that the fluid container’s connection adapter fits properly.
•Turn the ancillary equipment back ON.
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4.4. Inspection of the Endoscopic System
Checking the Working Channel 6
•Confirm that the biopsy valve is attached to the working channel port.
•Endoscopic instruments labeled for use with a working channel size (ID) of 2.8 mm or
less are compatible.
•There is no guarantee that endoscopic instruments selected solely using this working
channel size will be compatible with the aScopeGastro.
•Compatibility of selected endoscopic instruments should be tested prior to procedure.
Inspection of the Image 7
•Verify that a live video image and correct orientation appears on the monitor by
pointing the distal end of the aScopeGastro towards an object, e.g. the palm of
your hand.
•Adjust the image preferences on the aBox 2 if necessary (please refer to the aBox 2
Instructions for Use).
•If the image is impaired and/or unclear, wipe the lens at the distal end using a
sterile cloth.
•The images must not be used as an independent diagnostic of any pathology.
Physicians must interpret and qualify any findings by other means and in the light
of the patient's clinical characteristics.
Checking the Remote Switches
•All remote switches should be checked to work normally even if they are not
expected to be used.
•Press every remote switch and confirm that the specified functions work as expected.
Checking the Suction, Rinsing and Insufflation Functionality
•Check that the suction and insufflation/rinsing valves work as expected by pressing
the suction and insufflation/rinsing valves.
•Cover the opening of the insufflation/rinsing valve and confirm that the insufflation
function works properly.
Checking the Auxiliary Water Jet Functionality
•Check that the auxiliary water jet system by activating the auxiliary water pump and
confirm that irrigation function works properly.
4.5. Operating the aScopeGastro
Insertion of the aScopeGastro 8
•Insert a suitable mouthpiece and place it between the patient's teeth or gums.
•If necessary, apply a medical-grade lubricant to the insertion section.
•Insert the distal end of the aScopeGastro through the opening of the mouthpiece,
then from the mouth to the pharynx while viewing the endoscopic image. Do not
insert beyond the proximal end maximum length mark.
Holding and Maneuvering the aScopeGastro
•The control section of the aScopeGastro is designed to be held in the operator's hand.
•The insufflation/rinsing and suction valves can be operated using a finger.
•The UP/DOWN angulation control wheel can be operated using the fingers.
•The operator's 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 aScopeGastro's angulation locks are used to hold the angulated distal end
in position.
Insufflation/Rinsing
•Cover the insufflation/rinsing valve’s hole to feed CO₂ from the insufflation/rinsing
valves at the distal end.
•Press the insufflation/rinsing valve to feed sterile water onto the objective lens.
•Always dispose of insufflation/rinsing tube and corresponding water bottle after
each endoscopic procedure.
Instillation of Fluids
•Fluids can be injected through the working channel by inserting a syringe into the
working channel port of the aScopeGastro. Insert the syringe completely into the
working channel port and press the plunger to inject fluid.
•Make sure you do not apply suction during this process, as this will direct the
injected fluids into the suction collection system. To ensure that all fluids have left
the channel, flush the channel with approx. 5 seconds of CO₂.
Auxiliary Water Jet System
•Activate the auxiliary Water Jet system in order to apply irrigation.
•A delay in irrigation may be experienced if the auxiliary Water Jet system has not
been pre-filled during the pre-procedural preparation.
•Always dispose of Water Jet tubing and corresponding water bottle after each
endoscopic procedure.
Suction
•Press the suction valve to aspirate excess fluids or other debris obscuring the
endoscopic image.
•For optimal suction capability it is recommended to remove accessories entirely
during suction.
•Should the suction valve on the aScopeGastro clog, you can remove and clean it or
replace it with the spare suction valve secured on the mounting card.
Insertion of Endoscopic Accessories
Always make sure to select the correct size endoscopic accessory for the aScopeGastro.
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Gastro. Refer to the
accessories instruction manuals for operating instructions.
•Always select the correct size endoscopic accessory compatible with the
aScopeGastro. There is no guarantee that instruments selected solely using this
minimum working channel size will be compatible in combination. Compatibility of
selected instruments should be assessed prior to the procedure.
•Confirm that the tip of the endoscopic accessory is closed or retracted into its sheath.
•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.
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Withdrawal of Endoscopic Accessories
•Ensure that the accessory/tool is in a neutral position and withdraw the accessory
from the aScopeGastro through the biopsy valve.
•If the accessory cannot be removed retract the aScopeGastro while observing
the endoscopic image.
Withdrawal of the aScopeGastro 9
•Stop using the image magnification (zoom) function of the aBox 2.
•Aspirate accumulated air, blood, mucus or other debris by depressing the suction valve.
•Move the Up/Down angulation lock to the "F" direction to release the angulation.
•Turn the Left/Right angulation lock to the “F” direction to release the angulation.
•Carefully withdraw the aScopeGastro while observing the endoscopic image.
•Remove mouthpiece from the patient´s mouth.
4.6. After Use
Detach the tubings from the Insufflation/Water, Suction and the Auxiliary Water systems
from the aScopeGastro Connector. 10
Press the Disconnection Button and disconnect the aScopeGastro from the aBox 2. 11
Check the aScopeGastro for any missing parts, evidence of damage, cuts, holes, sagging,
or other irregularities on the bending and insertion section including the distal end of
the aScopeGastro. 12
Should any irregularities exist, immediately determine if any parts are missing and take
the necessary corrective action(s).
Discard the aScopeGastro in accordance with local guidelines for medical waste with
electronic components. 13
Returning Devices to Ambu
Should it be necessary to return an aScopeGastro to Ambu for evaluation, please
contact your representative at Ambu beforehand for instructions and/or guidance.
To prevent infection, it is strictly forbidden to ship contaminated medical devices.
The medical device aScopeGastro must be decontaminated on site prior to shipment to
Ambu. Ambu reserves the right to return contaminated medical devices to the sender.
Disposal of the aScopeGastro
The aScopeGastro is for single-use only.
Do not soak, rinse or sterilize as it may leave harmful residues or cause malfunction of
the aScopeGastro. The design and material used are not compatible with conventional
cleaning and sterilization procedures.
Discard all the packaging including the spare suction valve after the procedure.
5. Technical Device Specifications
5.1. Standards Applied
The aScopeGastro conforms with:
– IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic
safety and essential performance.
– IEC 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic
safety and essential performance – Collateral standard: Electromagnetic disturbances –
Requirements and tests.
– IEC 60601-2-18 Medical electrical equipment – Part 2-18: Particular requirements for the
basic safety and essential performance of endoscopic equipment.
– ISO 10993-1 Biological evaluation of medical devices – Part 1: Evaluation and testing
within a risk management process.
– ISO 8600-1 Endoscopes – Medical endoscopes and endotherapy devices – Part 1:
General requirements.

5.2. aScopeGastro Specifications
No. Product Specification
1Insertion Section Dimensions
1.1 Bending angle Up: 210°
Down: 90°
Left: 100°
Right: 100°
1.2 Max. Insertion tube diameter 10.4 mm
1.3 Distal tip diameter 9.9 mm
1.4 Working length 1030 mm
2Working Channel
2.1 Min. working channel width 2.8 mm
3 Optics
3.1 Field of view 140°
3.2 Direction of view 0 ° (forward pointing)
3.3 Depth of field 3 – 100 mm
3.4 Illumination method LED
4Connections
4.1 Medical grade CO₂ insufflator Max. 12 psi/80 kPa
(relative pressure)
4.2 Vacuum source Max. -11 psi /-76 kPa
(relative pressure)
4.3 Irrigation pump Max. 72.5 psi/500 kPa
(relative pressure)
5Operating Environment
5.1 Temperature 10 – 40 °C
5.2 Relative humidity 30 – 85 %
5.3 Atmospheric pressure 80 – 106 kPa
6Sterilization
6.1 Method of sterilization Ethylene oxide (EtO)
7Biocompatibility
7.1 aScopeGastro is biocompatible
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8Storage and Transportation Conditions
8.1 Transportation temperature -10 – 55 °C
8.2 Storage temperature 10 – 25 °C
8.3 Relative humidity 10 – 95 %
8.4 Atmospheric pressure 50 – 106 kPa
6. Trouble Shooting
The following table shows the possible causes of and counter measures against
challenges that may occur due to equipment setting errors or damage to the
aScopeGastro. Make sure to contact your local Ambu representative for detailed
information.
Prior to use please do the pre-check as described in the Quick Guide.
6.1. Angulation, Bending and Angulation Locks
Possible Problem Possible Cause Recommended Action
Increased resistance
during angulation
control wheel operation.
The angulation lock
is engaged.
Release the angulation lock.
Angulation lock
in attracted mode.
Angulation lock is not
correctly attracted.
Check whether the correct
angulation lock is attracted.
Distal end does not
angulate when control
wheel is operated.
aScopeGastro
is defective.
Withdraw the aScopeGastro
and connect a new scope.
Max. bending angles
cannot be achieved.
aScopeGastro
is defective.
Withdraw the aScopeGastro
and connect a new scope.
Bending section
angulates in the
opposite direction.
aScopeGastro
is defective.
Withdraw the aScopeGastro
and connect a new scope.
6.2. Rinsing and Insufflation
Possible Problem Possible Cause Recommended Action
Rinsing not possible. Rinsing tubing not
properly connected.
Connect the rinsing
tubing properly to the
aScopeGastro.
CO₂ regulator
is not functioning.
Refer to the CO₂
regulator IFU.
Sterile water source
set-up sub-optimal.
Refer to the water
source IFU.
aScopeGastro
is defective.
Withdraw the aScopeGastro
and connect a new scope.

Possible Problem Possible Cause Recommended Action
Insufflation not possible. CO₂ regulator
is not functioning.
Refer to the CO₂
regulator IFU.
Sterile water source
set-up sub-optimal.
Refer to the water
source IFU.
aScopeGastro
is defective.
Withdraw the aScopeGastro
and connect a new scope.
Continuous insufflation
without operating
insufflation/rinsing valve.
Insufflation/ rinsing valve
opening is blocked.
Withdraw the aScopeGastro
and connect a new scope.
Insufficient insufflation. CO₂ insufflator
is not connected
or not switched ON.
Connect/switch on
compatible insufflator.
Adjust insufflator settings.
CO₂ – source is empty. Connect a new
CO₂ – source.
Suction is activated. Deactivate suction.
6.3. Suction
Possible Problem Possible Cause Recommended Action
Diminished
or no suction.
Vacuum source/suction
pump is not connected
or not switched ON.
Connect the vacuum source/
suction pump
and power ON.
Suction canister is full
or not connected.
Change the suction
canister if it is full.
Connect a suction canister.
Suction valve is blocked. Remove the valve and rinse
with sterile water using a
syringe and reuse the valve.
Or replace with the spare
suction valve.
Biopsy valve is not
properly connected.
Attach valve correctly.
Biopsy valve cap is open. Close cap.
Vacuum source/suction
pump to weak
(min. -7 kPa).
Increase vacuum pressure.
Vacuum source/suction
pump is defective.
Replace with a new vacuum
source/suction pump.
Working channel blocked. Flush sterile water with
a syringe through the
working channel.
aScopeGastro
is defective.
Withdraw the aScopeGastro
and connect a new scope.
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6.4. Working Channel
Possible Problem Possible Cause Recommended Action
Working channel
or access is
constricted or
blocked (accessory
instruments does
not pass through
channel smoothly).
Endoscopic accessory
is not compatible.
Select a compatible
accessory.
Endoscopic accessory
is open.
Close the endoscopic
accessory or retract it
into its sheath.
Working channel is blocked. Try to unblock it by
flushing sterile water
into the working
channel with a syringe.
Biopsy valve is not open. Open the cap of
the biopsy valve.
6.5. Image Quality and Brightness
Possible Problem Possible Cause Recommended Action
No video image. aBox 2 or ancillary equipment
not switched on.
Switch aBox 2 and
ancillary equipment on.
aScopeGastro connector
is not properly connected
to the aBox 2.
Connect the aScopeGastro
connector properly to
the aBox 2.
aScopeGastro is defective. Withdraw the aScopeGastro
and connect a new scope.
aBox 2 defective. Contact your Ambu
representative.
Image
suddenly darkens.
Camera or illumination failure. Withdraw the aScopeGastro
and connect a new scope.
Blurry image. Objective lens is dirty. Rinse the objective lens.
Water drops on the outside
of the lens.
Insufflate and/or rinse
to remove water drops
from the lens.
Condensation on the inside
of the lens.
Increase the water
temperature in the water
container and continue to
use the aScope Gastro.
aBox 2 Image settings incorrect. See aBox 2 IFU.
Flickering images. Signal interference from
activated high-frequency
current.
Use alternative mode or
settings on the HF-generator
with lesser Peak Voltage (pV).

Possible Problem Possible Cause Recommended Action
Dark or over-
illuminated image.
aBox 2 Image
settings incorrect.
See aBox 2 IFU.
aScopeGastro defective. Withdraw the aScopeGastro
and connect a new scope.
The color tone of
the endoscopic
image is unusual.
aScopeGastro defective. Withdraw the aScopeGastro
and connect a new scope.
Picture is frozen. aScopeGastro defective. Withdraw the aScopeGastro
and connect a new scope.
aBox 2 defective. Contact your Ambu
representative.
6.6. Remote Switches
Possible Problem Possible Cause Recommended Action
The remote
switches are not
working or not
working properly.
aScopeGastro connector
is not properly connected
to the aBox 2.
Connect the aScopeGastro
connector properly to
the aBox 2.
Remote switches
configuration changed.
Return to standard
configuration of the
remote switches or
change the settings.
Wrong remote
switch operated.
Operate the correct
remote switch.
aScopeGastro defective. Withdraw the aScopeGastro
and connect a new scope.
aBox 2 defective. Contact your
Ambu representative.
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