Ambu aScope™ 4 Broncho Sampler Set Instrucțiuni de utilizare

Ambu® aScope™ 4

Broncho Sampler Set Family

INSTRUCTIONS

FOR USE

For use by trained clinicians/physicians only.

For in-hospital use.

For use with Ambu® displaying units.

Ambu® aScope™ 4 Broncho Regular Sampler Set

Ambu® aScope™ 4 Broncho Large Sampler Set

a

b

e f g

e f g h

h

Contents Page

English (Instruction for use) ..................................................................................................................................4-15

Български (Инструкция за употреба) ........................................................................................................16-28

Čeština (návod k použití).................................................................................................................................... 29-40

Dansk (brugsanvisning) ....................................................................................................................................... 41-52

Deutsch (Bedienungsanleitung) ......................................................................................................................53-65

Ελληνικά (Οδηγίες χρήσης) ................................................................................................................................66-79

Español (Instrucciones de uso) ........................................................................................................................ 80-92

Eesti (Kasutusjuhend) .........................................................................................................................................93-104

Käyttöohje (suomi) ............................................................................................................................................105-116

Français (Mode d'emploi) ................................................................................................................................117-129

Hrvatski (Upute za upotrebu) ....................................................................................................................... 130-141

Magyar (Használati útmutató) ......................................................................................................................142-153

Italiano (Istruzioni per l'uso).......................................................................................................................... 154-165

日本語（使用説明書 ) ...................................................................................................................................... 166-176

Lietuviškai (naudojimo instrukcija) .............................................................................................................177-188

Latviešu val. (Lietošanas pamācība) ..........................................................................................................189-200

Nederlands (Gebruiksaanwijzing) ...............................................................................................................201-213

Norsk (Bruksanvisning) ...................................................................................................................................214-225

Polski (Instrukcja obsługi) ..............................................................................................................................226-238

Português (Instruções de utilização) ......................................................................................................... 239-251

Română (Instrucțiuni de utilizare) ..............................................................................................................252-264

Slovenčina (Návod na použitie) ................................................................................................................... 265-277

Slovenšcina (Navodila za uporabo) ............................................................................................................278-289

Svenska (Instruktionshandbok) ...................................................................................................................290-301

Türkçe (Kullanım talimatları) ......................................................................................................................... 302-313

中文（使用说明） ............................................................................................................................................. 314-323

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1. Important information – Read before use

Read these safety instructions carefully before using the aScope4 Broncho Sampler Set.

The Instructions for use may be updated without further notice. Copies of the current version

are available upon request. Please be aware that these instructions do not explain or discuss

clinical procedures. They describe only the basic operation and precautions related to the

operation of the endoscope and BronchoSampler. Before initial use of the Sampler Set, it is

essential 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 on the sampler set.

In this document endoscope refers to instructions which applies to the endoscope only and

system refers to information relevant for the aScope 4 Broncho and the compatible Ambu

displaying unit and accessories. Unless specified otherwise, endoscope refers to all aScope4

Broncho variants available for sampler set.

1.1. Intended use

aScope4 Broncho Sampler Set consists of sterile, single-use, flexible endoscope with sample

containers (aScope BronchoSampler), intended for endoscopic procedures and examination

within the airways and tracheobronchial tree. aScope BronchoSampler is designed as an add-

on to aScope4 Broncho during Bronchial Alveolar Lavage (BAL) or Bronchial Wash (BW)

procedure which enables aspiration and collection of fluid sample(s) from the bronchial or

alveolar part of the lung.

It is designed for use in adults and intended for use in a hospital environment. It is intended to

provide visualization via Ambu Displaying Unit.

1.2. Contra indications

None known.

1.3. Clinical benefits

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

1.4. 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

1. The endoscope is a single-use device and must be handled in a manner consistent

with accepted medical practice for such devices in order to avoid contamination of

the endoscope prior to insertion.

2. The endoscope images must not be used as an independent diagnostic of any

pathology. Physicians must interpret and substantiate any finding by other means

andin the light of the patient's clinical characteristics.

3. Do not use active endoscopic accessories such as laser probes and electrosurgical

equipment in conjunction with the endoscope, as this may result in patient injury or

damage to the endoscope.

4. The device should not be used if adequate supplemental oxygenation cannot be

provided to the patient during the procedure.

5. The user must exercise professional judgement when deciding whether a bronchoscopy

procedure will be appropriate for patients with the following conditions, since they have

a higher rate of serious complications; malignant arrhythmia, unstable cardiac status,

acute myocardial infraction within 4-6 weeks, refractory hypoxemia, bleeding diathesis

or severe thrombocytopenia if biopsy is indicated.

6. Do not use the endoscope if it is damaged in any way or if any part of the functional

check (see section 4.1) fails.

7. Do not attempt to clean and reuse the endoscope as it is a single-use device.

Reuse of the product can cause contamination, leading to infections.

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8. The endoscope is not to be used when delivering oxygen or highly flammable

anaesthetic gases to the patient. This could potentially cause patient injury.

9. The endoscope is not to be used in a MRI environment.

10. Do not use the endoscope during defibrillation.

11. Only to be used by skilled physicians trained in clinical endoscopic techniques

and procedures.

12. Do not use excessive force when advancing, operating or withdrawing the endoscope.

13. Patients should be adequately monitored at all times during use.

14. Always watch the live endoscopic image on the displaying unit when advancing or

withdrawing the endoscope, operating the bending section or suctioning. Failure to

do so may harm the patient.

15. Do not use the endoscope if the product sterilisation barrier or its packaging is damaged.

16. The distal tip of the endoscope may get warm due to heating from the light emission

part. Avoid long periods of contact between the distal tip and the mucosal membrane

as long, sustained contact with the mucosal membrane may cause mucosal injury.

17. Always make sure that any tube connected to the suction connector is connected to

asuction device.

18. When withdrawing the endoscope, the distal tip must be in neutral and non-deflected

position. Do not operate the control lever, as this may result in injury to the patient

and/or damage to the endoscope.

19. Do not advance or withdraw the endoscope, or operate the bending section,

whileendoscopic accessories are protruding from the distal tip of the working

channel, asthis may result in injury to the patient.

20. Always make sure that the bending section is in a straight position when inserting or

withdrawing an endoscopic accessory in the working channel. Do not operate the

control lever and never use excessive force, as this may result in injury to the patient

and/or damage to the endoscope.

21. Always perform a visual check according to the instructions in this Instructions for Use

before placing the endoscope in a waste container.

22. Electronic equipment and the endoscope system may affect the normal function of

each other. If the system is used adjacent to or stacked with other equipment, observe

and verify normal operation of both the system and the other electronic equipment

prior to using it. It may be necessary to adopt procedures for mitigation, such as

reorientation or relocation of the equipment or shielding of the room in which it is used.

23. The endoscope consists of parts supplied by Ambu. These parts must only be replaced

by Ambu authorised parts. Failure to comply with this may result in patient injury.

24. Be careful to 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.

25. To avoid risk of electric shock, the system must only be connected to a supply mains

with protective earth. To disconnect the system from mains remove the mains plug

from the wall outlet.

26. Always check compatibility with endotracheal tubes and double lumen tubes.

27. If any malfunction should occur during the endoscopic procedure, stop the procedure

immediately and withdraw the endoscope.

28. Insert the syringe completely into the working channel port before instilling fluid.

Failure to do so may result in the fluid spilling from the working channel port.

CAUTIONS

1. Have a suitable backup system readily available for immediate use so the procedure

can be continued if a malfunction should occur.

2. Be careful not to damage the insertion cord or distal tip when using sharp devices

such as needles in combination with the endoscope.

3. Be careful when handling the distal tip and do not allow it to strike other objects,

asthis may result in damage to the equipment. The lens surface of the distal tip is

fragile and visual distortion may occur.

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4. Do not exert excessive force on the bending section as this may result in damage to

the equipment. Examples of inappropriate handling of the bending section include:

– Manual twisting.

– Operating it inside an ETT or in any other case where resistance is felt.

– Inserting it into a preshaped tube or a tracheostomy tube with the bending

direction not aligned with the curve of the tube.

5. US federal law restricts these devices for sale only by, or on the order of, a physician.

6. Keep the endoscope handle dry during preparation, use and storage.

7. Do not use a knife or other sharp instrument to open the pouch or cardboard box.

8. Secure the tubing properly on the suction connector before suction is applied.

9. If needed remove secretion or blood from the airway before and during the

procedure. The suction function of any appropriate suction device can be used for

thispurpose.

10. Apply a vacuum of 85kPa (638mmHg) or less when suctioning. Applying too large

avacuum may make it difficult to terminate suctioning.

11. For single use only. Use on other patients can cause cross contamination. Do not soak,

rinse, or sterilize this device as these procedures may leave harmful residues or cause

malfunction of the device.

1.5. Potential adverse events

Potential adverse events in relation to flexible bronchoscopy (not exhaustive): Tachycardia/

bradycardia, hypotension, bleeding, bronchospasm/laryngospasm, cough, dyspnoea, sore

throat, apnoea, seizure, desaturation/hypoxemia, epistaxis, haemoptysis, pneumothorax,

aspiration pneumonia, pulmonary oedema, airway obstruction, reaction to drug or topical

anaesthesia, fever/infection, and respiratory/cardiac arrest.

1.6. 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. System description

The aScope 4 Broncho can be connected to the Ambu displaying unit. For information about

the Ambu displaying unit, please refer to the displaying unit Instruction for use.

2.1. System parts

Ambu® aScope™ 4 Broncho Sampler Set -

Single use device

Part numbers

477501000 aScope 4 Broncho Regular

Sampler Set 5.0/2.2

478501000 aScope 4 Broncho Large

Sampler Set 5.8/2.8

aScope 4 Broncho Regular Sampler Set and aScope4 Broncho Large Sampler Set are not

available in all countries. Please contact your local sales office.

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aScope 4 Broncho Colour Outer diameter

[mm]

Inner diameter

[mm]

aScope4 Broncho Regular 5.0/2.2

aScope4 Broncho Large 5.8/2.8

Green

Orange

min 5.0; max 5.5

min 5.8; max 6.3

min 2.0

min 2.6

aScope BronchoSampler Packaging

configuration

Sampler

bridge

Sample

container

Suction

adapter

1 pc 2 pcs 1 pc

2.2. Product compatibility

Displaying unit

– Ambu aView and aView2 Advance.

Endoscopic accessories

– Accessories with standard 6 % Introducer (Luer slip) and/or Luer lock.

Endotracheal tubes (ETT) & Double lumen tubes (DLT)

– Tracheal tubes for use in anaesthetic and respiratory equipment in compliance with EN ISO 5361.

The aScope 4 Broncho Sampler Set has been evaluated to be compatible with the following

endotracheal tubes (ETT), double lumen tubes (DLT) and Endoscopic accessories (EA) sizes.

Minimum ETT

Inner diameter

Minimum

DLT size

EA minimum working

channel width

aScope 4 Broncho Regular

aScope 4 Broncho Large

6.0mm

7.0mm

41Fr Up to 2.0mm

Up to 2.6mm

Suctioning equipment

– Suction tube of diameters between 6.5mm & 9.5mm.

Sample container

– Ambu® aScope BronchoSampler™ 60 SC.

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2.3. aScope 4 Broncho Sampler Set parts

3

4

5

12

7

6

8

9

10

11

12 19

C

B15

17

18

16

20

24

23 22 21

D

A

13

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Item Function

AaScope4 Broncho Flexible endoscope intended for endoscopic

procedures and examination within the airways

andtracheobronchial tree.

No. Part Function

1Handle Suitable for left and right hand.

2Control lever Moves the distal tip up or down in

a single plane.

3Working channel port Allows for instillation of fluids and insertion of

endoscopic accessories.

-Working channel Can be used for instillation of fluids,

suctionandinsertion of endoscopic accessories.

4Suction connector Allows for connection of suction tubing.

5Suction button Activates suction when pressed down.

6Tube connection Allows for fixation of tubes with standard connector

during procedure.

7Insertion cord Flexible airway insertion cord.

Insertion portion Same as insertion cord.

8Bending section Manoeuvrable part.

9Distal tip Contains the camera, light source (two LEDs),

as well as the working channel exit.

10 Connector on

endoscope cable

Connects to blue socket on displaying unit.

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11 Endoscope cable Transmits the image signal to the displaying unit.

12 Protection pipe Protects the insertion cord during transport and storage.

Remove before use.

13 Handle protection Protects the suction connector during transport

andstorage. Remove before use.

14 Introducer To facilitate introduction of Luer Lock syringes and soft

endoscopic accessories through the working channel.

Item Function

BSample container Connects to the sampler bridge and holds the

retrievedsample.

No. Part Function

15 Flip top

Acts as click-on locking mechanism for sample container.

To be pressed down anteriorly to disengage locking

mechanism.

16 Sample container lid For closing and protecting the sample.

17 Connection interface For connection of sampler bridge and sample container.

18 Sample container glass For storage of sample.

Item Function

CSuction adapter For connection to a male suction adapter

and the suction connector.

No. Part Function

19 Suction adapter For connection to a male suction adapter

and the suction connector.

Item Function

DSampler bridge Connects to the aScope 4 Broncho, and creates

aclosed loop for sampling and/or suctioning.

No. Part Function

20 Suction connector For connection of suction tubing.

21 aScope 4 Broncho

connection interface

For introduction of aScope4 Broncho suction connector,

to establish connection.

22 Attachment lock Locks the sampler bridge to the aScope4 Broncho.

23 Flow switch Determines suction flow direction and switches

between general suction and sampling.

24 Connection interface For connection of sampler bridge and sample container.

3. Explanation of symbols used

Symbols for the aScope4

Broncho Sampler Set

Indication

Working length of the insertion cord.

Max OD Maximum insertion portion width

(Maximum outer diameter).

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Symbols for the aScope4

Broncho Sampler Set

Indication

Min ID Minimum working channel width

(Minimum inner diameter).

Field of view.

%Relative humidity limitation.

Atmospheric pressure limitation.

Temperature limitation.

Electrical Safety Type BF Applied Part.

Packaging level ensuring sterility.

UL Recognized Component Mark for Canada and

theUnited States.

Medical device.

Global Trade Item Number.

Country of manufacturer.

Do not use if the product sterilisation barrier

or its packaging is damaged.

UK Conformity Assessed.

UK Responsible Person.

Importer

(For products imported into Great Britain only).

A supplementing list of symbol explanations can be found on www.ambu.com/symbol-explanation.

4. Use of aScope 4 Broncho Sampler Set

Numbers in gray circles below refer to illustrations on page 2.

4.1. Preparation and inspection of aScope 4 Broncho Sampler Set

Visual inspection of the endoscope 1

1. Check that the pouch seal is intact. 1a

2. Make sure to remove the protective elements from the handle and from the

insertioncord. 1b

3. Check that there are no impurities or damage on the product such as rough surfaces,

sharp edges or protrusions which may harm the patient. 1c

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Refer to the Ambu displaying unit Instruction for use for preparation and inspection

of the Ambu displaying unit 2

Inspection of the image

1. Plug in the endoscope cable connector into the corresponding connector on the

compatible displaying unit. Please ensure the colours are identical and be careful to align

the arrows. 3

2. Verify that a live video image appears on the screen by pointing the distal tip of the

endoscope towards an object, e.g. the palm of your hand. 4

3. Adjust the image preferences on the displaying unit if necessary (please refer to the

displaying unit Instruction for use).

4. If the object cannot be seen clearly, wipe the lens at the distal tip using a sterile cloth.

Preparation of aScope 4 Broncho Sampler Set

1. Carefully slide the control lever forwards and backwards to bend the bending section as

much as possible. Then slide the control lever slowly to its neutral position. Confirm that

thebending section functions smoothly and correctly and returns to a neutral position. 5a

2. Using a syringe insert 2ml of sterile water into the working channel port (if applying a

Luer Lock syringe use the enclosed introducer). Press the plunger, ensure that there are

noleaks, and that water is emitted from the distal tip. 5b

3. If applicable, prepare the suction equipment according to the supplier’s manual. 5c

Connect the suctioning tube to the suction connector and press the suction button to

check that suction is applied.

4. If applicable, verify that endoscopic accessory of appropriate size can be passed through

the working channel without resistance. The enclosed introducer can be used to facilitate

the insertion of soft accessories such as microbiology brushes. 5d

5. If applicable, verify that endotracheal tubes and double lumen tubes are compatible with

endoscope before starting the procedure.

6. Carefully connect the sampler bridge of the BronchoSampler with the aScope4 Broncho,

by mounting the sampler bridge on the aScope4 Broncho suction connector. Ensure a

tight fit. 5e

7. Press the attachment lock button to secure connection. 5f

8. Carefully connect the vacuum suction tubing to the suction connector according to the

supplier’s manual. If vacuum suction tubing has male connector, use the suction adapter

to ensure fit. 5g

9. Attach the sample container to the sampler bridge by joining the connection interfaces

and pressing the sample container towards the sampler bridge. Ensure the sample

container is clicked on. Do not use preservatives in the sample container. 5h

4.2. Operating the aScope 4 Broncho

Holding the aScope 4 Broncho and manipulating the tip 6a

The handle of the endoscope can be held in either hand. The hand that is not holding the

endoscope can be used to advance the insertion cord into the patient’s mouth or nose.

Use the thumb to move the control lever and the index finger to operate the suction button.

The control lever is used to flex and extend the distal tip of the endoscope in the vertical plan.

Moving the control lever downward will make the tip bend anteriorly (flexion). Moving it

upward will make the distal tip bend posteriorly (extension). The insertion cord should be held

as straight as possible at all times in order to secure an optimal distal tip bending angle.

Tube connection 6b

The tube connection can be used to mount ETT and DLT with an ISO connector during intubation.

Insertion of the aScope 4 Broncho 7a

Lubricate the insertion cord with a medical grade lubricant when the endoscope is inserted

into the patient. If the camera image of the endoscope becomes unclear the distal tip can be

cleaned by gently rubbing the distal tip against the mucosal wall or remove the endoscope

and clean the tip. When inserting the endoscope orally, it is recommended to use amouthpiece

to protect the endoscope from being damaged.

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Instillation of fluids 7b

Fluids can be instilled through the working channel by inserting a syringe into the working

channel port at the top of the endoscope. When using a Luer Lock syringe, use the included

introducer. Insert the syringe completely into the working channel port or the introducer and

press the plunger to instill fluid. Make sure you do not apply suction during this process, as this

will direct the instilled fluids into the suction collection system. To ensure that all fluid has left

the channel, flush the channel with 2 ml of air. It is recommended to remove introducer from

the working channel port when it is not in use.

Aspiration 7c

When a suction system is connected to the suction connector, suction can be applied by pressing

the suction button with the index finger. If the introducer and/or an endoscopic accessory is

placed inside the working channel note that the suction capability will be reduced. For optimal

suction capability it is recommended to remove the introducer or syringe entirely during suction.

Insertion of endoscopic accessories 7d

Always make sure to select the correct size endoscopic accessory for the endoscope (refer to

section 2.2). 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 displaying unit. The enclosed introducer can be used to facilitate the insertion of soft

accessories such as microbiology brushes.

Operating with the Broncho Sampler Set

1. If suction is deemed relevant before sampling, ensure that the flow switch is aligned

vertically and pointing upwards, and perform suction by pressing the suction button on

the aScope 4 Broncho in accordance with Instruction for use for aScope 4 Broncho. 7e

2. To prepare for sampling of specimen, turn the flow switch counter-clockwise towards

thesample container, and align it horizontally. 7f

3. Perform sampling by pressing the suction button on the aScope 4 Broncho. Do not fill

thesample container above the maximum of the volume indicator scale.

4. If suction is deemed relevant, turn the flow switch clockwise to align it vertically and

pointing upwards, and press the suction button on the aScope 4 Broncho. When suction

is complete, turn the flow regulator counter-clockwise towards the sample container,

andalign it horizontally.

5. Remove the sample container by pressing the flip top, and pull the sample container from

the sampler bridge. 7g

6. Close the sample container by pressing the sample container lid towards the sample

container interface and engage the click-lock. Once the click-lock is engaged, do not

re-open the lid. 7h

Withdrawal of the aScope 4 Broncho Sampler Set

1. If deemed relevant, detach the sampler bridge from the aScope 4 Broncho by disengaging

the attachment lock, and pull the sampler bridge off the aScope 4 Broncho. Disengage

suction by pulling the suction tube off the sampler bridge.

2. If deemed relevant, the sample can be accessed by unscrewing the sample container glass

counter-clockwise. It is recommended to handle contaminated substances in accordance

with local guidelines. 8a

3. Transportation and handling of sample container must be performed in accordance with

local guidelines for transportation and handling of hazardous material.

4. When withdrawing the aScope 4 Broncho, make sure that the control lever is in the

neutral position. Slowly withdraw the endoscope while watching the live image on

thedisplaying unit. 8b

4.3. After use

Visual check 9

1. Are there any missing parts on the bending section, lens, or insertion cord? If yes, then

take corrective action to locate the missing part(s).

2. Is there any evidence of damage on the bending section, lens, or insertion cord? If yes,

then examine the integrity of the product and conclude if there are any missing parts.

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3.

Are there cuts, holes, sagging, swelling or other irregularities on the bending section,

lens, or insertion cord? If yes, then examine the product to conclude if there are any

missing parts.

In case of corrective actions needed (step 1 to 3) act according to local hospital procedures.

The elements of the insertion cord are radio opaque.

Disconnect

Disconnect the endoscope from the displaying unit 10 . The aScope 4 Broncho Sampler Set is

asingle use device. The aScope 4 Broncho Sampler Set is considered infected after use and

must be disposed of in accordance with local guidelines for collection of infected medical

devices with electronic components. Do not soak rinse, or sterilize this device as these procedures

may leave harmful residues or cause malfunction of the device. The design and material used

are not compatible with conventional cleaning and sterilization procedures.

Disposal 11

The sampler set is for single-use only. This means that all components must be disposed

ofonce opened and unused components cannot be saved for later use. The disposal must

bein accordance with local guidelines for collection of infected medical devices with

electronic components.

5. Technical product specifications

5.1. Standards applied

The aScope 4 Broncho Sampler Set conforms with:

– EN 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and

essential performance.

– EN 60601-2-18 Medical electrical equipment – Part 2-18: Particular requirements for the basic

safety and essential performance of endoscopic equipment.

– ISO 8600-1: Endoscopes - Medical endoscopes and endotherapy devices – Part 1:

General requirements.

– EN 14254: In Vitro Diagnostic medical devices – Single-use receptacles for the collection of

specimens, other than blood, from humans.

5.2. aScope 4 Broncho Sampler Set specifications

Insertion cord aScope 4 Broncho Regular aScope 4 Broncho Large

Bending section¹ [°] 180 ,180 180 ,160

Insertion cord diameter [mm, (”)]

5.0 (0.20) 5.8 (0.23)

Distal tip diameter [mm, (”)] 5.4 (0.21) 6.3 (0.25)

Maximum diameter of

insertion portion [mm, (”)]

5.5 (0.22) 6.3 (0.25)

Minimum endotracheal

tube size (ID) [mm]

6.0 7.0

Minimum double lumen

tube size (ID) [Fr]

41 -

Working length [mm, (”)] 600 (23.6) 600 (23.6)

Working channel aScope 4 Broncho Regular aScope 4 Broncho Large

Minimum instrument

channel width² [mm, (”)]

2.0 (0.079) 2.6 (0.102)

Storage aScope 4 Broncho Regular/Large Sampler Set

Temperature³ [°C, (°F)] 10 – 25 (50 – 77)

Relative humidity [%] 10 – 85

Atmospheric pressure [kPa] 50 – 106

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Transportation aScope 4 Broncho Regular/Large Sampler Set

Temperature³ [°C, (°F)] -10 – 55 (14 – 131)

Relative humidity [%] 10 – 95

Atmospheric pressure [kPa] 50 – 106

Optical system aScope 4 Broncho Regular/Large

Field of View [°] 85

Direction of view [°] 0 (forward pointing)

Depth of Field [mm] 6 – 50

Illumination method LED

Suction connector

Connecting tube ID [mm] Ø 6.5 – 9.5

Connecting tube

with female interface

ID = Ø 7 ± 1mm

Connecting tube with

male interface.

Applicable when suction

adapter is used

OD = Ø 7 ± 1mm

1. Please check for compatibility with suction tubing before use

Sample container Specification

Sample Container volume 30ml

Sterilisation aScope 4 Broncho Regular/Large Sampler Set

Method of sterilisation ETO

Operating environment aScope 4 Broncho Regular/Large Sampler Set

Temperature [°C, (°F)] 10 – 40 (50 – 104)

Relative humidity [%] 30 – 85

Atmospheric pressure [kPa] 80 – 106

Altitude [m] ≤ 2000

1. Please be aware that the bending angle can be affected if the insertion cord is not kept straight.

2. There is no guarantee that accessories selected solely using this minimum instrument channel

width will be compatible in combination.

3. Storage under higher temperatures may impact shelf life.

6. Trouble shooting

If problems occur with the system, please use this trouble shooting guide to identify the cause

and correct the error.

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Problem Possible cause Recommended action

No live image

on the left side of

the screen but User

Interface is present

on the display or

the image shown to

the left is frozen.

The endoscope not

connected to the

displaying unit.

Connect an endoscope to the blue port

on the displaying unit.

The displaying unit

and the endoscope

have communication

problems.

Restart the displaying unit by pressing

the power button for at least 2 seconds.

When the displaying unit is off restart by

pressing power button once more.

The endoscope

is damaged.

Replace the endoscope with a new one.

A recorded image is

shown in the yellow

file management tab.

Return to live image by pressing the blue

live image tab or restart the displaying

unit by pressing the power button for at

least 2 seconds. When the displaying unit

is off restart by pressing power button

once more.

Low picture quality. Blood, saliva etc. on

the lens (distal tip).

Gently rub the distal tip against the

mucosa. If the lens cannot be cleaned

this way remove the endoscope and wipe

the lens with sterile gauze.

Absent or

reduced suction or

sampling capability

or difficulty in

inserting endoscopic

accessory through

the working channel.

Working channel

blocked.

Clean the working channel using a cleaning

brush or flush the working channel with

sterile saline using a syringe. Do not operate

the suction button when instilling fluids.

Suction pump is

not turned on or

not connected.

Turn the pump on and check the suction

line connection.

Suction button

is damaged.

Prepare a new endoscope.

Endoscopic accessory

inserted in working

channel (applicable

if suction is absent

or reduced).

Remove endoscopic accessory.

Check that the accessory used is of

the recommended size.

Bending section not

in neutral position.

Move bending section into neutral

position.

Soft endoscopic

accessory difficult to

pass through working

channel port.

Use one of the enclosed introducers.

No sample container

is attached, or poor

connection of

sample container.

Connect or re-connect sample container

to the sampler bridge.

Sampler bridge may

not be connected

properly to the

aScope 4 Broncho.

Re-connect the sampler bridge to aScope

4 Broncho, and press the attachment lock

button to secure connection.

Vacuum suction

tubing is not

connected properly

to suction connector,

or to suction adapter.

Ensure that the parts are properly

connected. If suction is still absent or

reduced change to another vacuum

suction tubing.

16

1. Важна информация – Прочетете преди употреба

Прочетете внимателно тези инструкции за безопасност, преди да използвате aScope 4

Broncho Sampler Set.  за употреба подлежат на актуализиране без

допълнително уведомление. Копия на текущата версия са налични при поискване.

Имайте предвид, че тези инструкции не разясняват и не разглеждат клиничните

процедури. Те описват само базовите операции и предпазните мерки, свързани с

работата с ендоскопа и Broncho Sampler. Преди първоначалната употреба на Sampler Set

е важно операторите да са получили достатъчно обучение за клиничните ендоскопски

техники и да са запознати с предназначението, предупрежденията, предпазните мерки и

показанията, посочени в тези инструкции.

Няма гаранция за Sampler Set.

В настоящия документ определението  се използва в инструкциите, които се

отнасят само за самия ендоскоп, a  – за информацията, отнасяща се за aScope 4

Broncho, съвместимия дисплеен модул Ambu и аксесоарите. Ако не е посочено нещо

друго, „ендоскоп“ се отнася за всичките варианти на aScope 4 Broncho, налични за

комплекта за проби.

1.1. Предназначение

aScope 4 Broncho Sampler Set се състои от стерилен гъвкав ендоскоп за еднократна

употреба и контейнери за проби (aScope BronchoSampler), предназначени за ендоскопски

процедури и изследвания в дихателните пътища и трахеобронхиалното дърво. aScope

BronchoSampler е предназначен като добавка към aScope 4 Broncho по време на

процедура по бронхоалвеоларен лаваж (BAL) или бронхиално промиване (BW), което

позволява аспирация и събиране на течни проби от бронхиалната или алвеоларната част

на белия дроб.

Устройството е предназначено за използване при възрастни и в болнична среда. Устройството

е предназначено да осигурява визуализация посредством дисплеен модул Ambu.

1.2. Противопоказания

Не са известни.

1.3. Клинични ползи

Приложението за еднократна употреба минимизира риска от кръстосана контаминация

на пациента.

1.4. Предупреждения и предпазни мерки

Неспазването на тези предупреждения и предпазни мерки може да доведе до

нараняване на пациента или повреда на оборудването. Ambu не носи отговорност за

каквато и да било повреда на системата или нараняване на пациента в резултат на

неправилно ползване.

ПРЕДУПРЕЖДЕНИЯ

1. Ендоскопът е изделие за еднократна употреба и с него трябва да се борави по

начин, който съответства на приетата медицинска практика за такива изделия, за

да се избегне рискът от контаминация на ендоскопа преди въвеждането му.

2. Изображенията от ендоскопа не трябва да се използват като независима

диагностика на каквато и да е патология. Лекарите трябва да тълкуват и

обосновават всяка находка с други средства и съгласно клиничните

характеристики на пациента.

3. Не използвайте активни ендоскопски аксесоари, като лазерни сонди и

електрохирургично оборудване, заедно с ендоскопа, тъй като това може да

доведе до нараняване на пациента или повреда на ендоскопа.

4. Изделието не трябва да се използва, ако по време на процедурата на пациента не

може да му се осигури адекватна допълнителна оксигенация.

5. Не използвайте ендоскопа, ако е повреден по някакъв начин или ако някоя част

от функционалната проверка (вижте раздел 4.1) е неуспешна.

6. Не се опитвайте да почиствате или да използвате повторно ендоскопа, защото

това е изделие за еднократна употреба. Повторната употреба на продукта може

да причини контаминация, водеща до инфекции.

17

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7. Ендоскопът не трябва да се използва, когато на пациента се подава кислород или

леснозапалими анестетични газове. Това може евентуално да доведе до

нараняване на пациента.

8. Ендоскопът не трябва да се използва в среда на МРТ.

9. Не използвайте ендоскопа по време на дефибрилация.

10. Да се използва само от квалифицирани лекари, обучени в клиничните

ендоскопски техники и процедури.

11. Не прилагайте прекомерна сила при вкарването, работата със или изваждането

на ендоскопа.

12. Пациентите следва да бъдат наблюдавани адекватно през цялото време на употреба.

13. Винаги следете ендоскопското изображение в реално време на дисплейния

модул при въвеждане или изтегляне на ендоскопа, при работа с гъвкавата част

или при сукция. Неспазването на това може да навреди на пациента.

14. Не използвайте ендоскопа, ако стерилизационната бариера на продукта или

опаковката му е увредена.

15. Дисталният връх на ендоскопа може да се загрее поради топлината от

излъчващата светлина част. Избягвайте дълги периоди на контакт между

дисталния връх и мукозната мембрана, тъй като продължителен контакт с

мукозната мембрана може да доведе до мукозно нараняване.

16. Винаги се уверявайте, че тръбата, свързана към сукционния конектор, е свързана

към сукционно устройство.

17. По време на изтегляне на ендоскопа дисталният връх трябва да бъде в неутрално

и ненаклонено положение. Не работете с лоста за управление, тъй като това

може да доведе до нараняване на пациента и/или повреда на ендоскопа.

18. Не вкарвайте и не изкарвайте ендоскопа, нито работете с гъвкавата секция,

докато от дисталния край на работния канал се подават ендоскопски аксесоари,

тъй като това може да доведе до нараняване на пациента.

19. Винаги се уверявайте, че гъвкавата секция е в право положение, когато поставяте

или изтегляте ендоскопски аксесоар в работния канал. Не работете с лоста за

управление и в никакъв случай не прилагайте прекомерна сила, тъй като това

може да доведе до нараняване на пациента и/или повреда на ендоскопа.

20. Винаги извършвайте визуална проверка в съответствие с указанията в настоящите

инструкции за употреба, преди да поставите ендоскопа в контейнер за отпадъци.

21. Електронното оборудване и ендоскопската система може да оказват взаимно

влияние върху нормалното си функциониране. Ако системата се използва в

непосредствена близост до или върху друго оборудване, наблюдавайте и

потвърдете нормалната работа както на системата, така и на другото електронно

оборудване, преди да ги използвате. Може да е необходимо да се приложат

процедури за смекчаване на смущенията, като например преориентиране или

преместване на оборудването, или екраниране на помещението, в което се използва.

22. Ендоскопът се състои от части, доставени от Ambu. Те могат да бъдат заменени

само от одобрени от Ambu части. Неспазването на това може да доведе до

нараняване на пациента.

23. Непременно проверете дали изображението на екрана е изображение в реално

време, или записано изображение, и проверете дали ориентацията на

изображението отговаря на очакванията.

24. За да се избегне рискът от токов удар, системата трябва да се свързва само към

захранваща електрическа мрежа със защитно заземяване. За да изключите

системата от електрическата мрежа, изключете захранващия щепсел от

електрическия контакт.

25. Винаги проверявайте съвместимостта с ендотрахеалните тръби и тръбите с

двоен лумен.

26. Ако по време на ендоскопската процедура възникне неизправност, незабавно

спрете процедурата и извадете ендоскопа.

27. Вкарайте докрай спринцовката в порта на работния канал, преди да влеете

течността. Неспазването на това може да доведе до разливане на течност от

порта на работния канал.

18

ПРЕДПАЗНИ МЕРКИ

1. Осигурете на разположение подходяща резервна система за незабавна употреба,

така че процедурата да може да продължи, ако възникне неизправност.

2. Бъдете внимателни, за да не повредите шнура за въвеждане или дисталния връх,

когато използвате остри предмети, като игли, в комбинация с ендоскопа.

3. Бъдете внимателни при боравене с дисталния връх и не позволявайте да се

докосва до други обекти, тъй като това може да доведе до повреда на

оборудването. Повърхността на лещите на дисталния връх е крехка и може да се

появи визуално изкривяване.

4. Не упражнявайте прекомерна сила върху гъвкавата секция, тъй като това може

да доведе до повреда на оборудването. Примерите за неправилно боравене с

гъвкавата секция включват:

– Ръчно усукване.

– Работа с нея в ETT или във всеки друг случай, когато се усеща съпротивление.

– Въвеждане в предварително оформена тръба или трахеостомична тръба с

посока на огъване, която не е подравнена с кривата на тръбата.

5. Федералното законодателство на САЩ налага ограничението тези изделия да се

продават само чрез или по поръчка на лекар.

6. Поддържайте дръжката на ендоскопа суха при подготовка, употреба и съхранение.

7. Не използвайте нож или друг остър инструмент за отваряне на торбичката или на

картонената кутия.

8. Укрепете тръбата по подходящ начин към сукционния конектор преди сукция.

9. Ако е необходимо, премахвайте секрецията или кръвта от дихателните пътища

преди и по време на процедурата. За тази цел може да бъде използвана

функцията за сукция с подходящо сукционно устройство.

10. По време на сукция прилагайте вакуум от 85 kPa (638 mmHg) или по-малко.

Прилагането на твърде голям вакуум може да доведе до трудно прекратяване

на сукцията.

11. Само за еднократна употреба. Употребата върху други пациенти може да доведе

до кръстосана контаминация. Не накисвайте, изплаквайте или стерилизирайте

това изделие, тъй като тези процедури може да оставят вредни остатъци или да

причинят неизправност на изделието.

1.5. Потенциални нежелани събития

Потенциални нежелани събития, свързани с гъвкава бронхоскопия (неизчерпателна

информация): Тахикардия/брадикардия, хипотония, кървене, бронхоспазъм/

ларингоспазъм, кашлица, диспнея, възпалено гърло, апнея, припадък, десатурация/

хипоксемия, епистаксис, хемоптиза, пневмоторакс, аспирационна пневмония,

пулмонална едема, обструкция на дихателните пътища, реакция към лекарство или

топична анестезия, пирексия/инфекция и респираторен/сърдечен арест.

1.6. Общи бележки

Ако по време на употреба на това изделие или като резултат от неговата употреба

възникнат сериозни инциденти, съобщете за тях на производителя и на националния

компетентен орган.

2. Описание на системата

aScope 4 Broncho може да се свърже към дисплеен модул Ambu. За информация относно

дисплейните модули Ambu вижте техните   .

19

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2.1. Части на системата

Ambu® aScope™ 4 Broncho Sampler Set –

изделие за еднократна употреба

Номера на части

477501000 aScope 4 Broncho Regular

Sampler Set 5.0/2.2

478501000 aScope 4 Broncho Large

Sampler Set 5.8/2.8

aScope 4 Broncho Regular Sampler Set и aScope 4 Broncho Large Sampler Set не са налични

във всички държави. Свържете се с местния търговски офис.

aScope 4 Broncho Цвят Външен

диаметър [mm]

Вътрешен

диаметър [mm]

aScope 4 Broncho Regular 5.0/2.2

aScope 4 Broncho Large 5.8/2.8

Зелено

Оранжево

мин. 5,0; макс. 5,5

мин. 5,8; макс. 6,3

мин. 2,0

мин. 2,6

aScope BronchoSampler

Конфигурация

на опаковката

Мост на

семплера

Контейнер

за проби

Сукционен

адаптер

1 бр. 2 бр. 1 бр.

2.2. Съвместимост на продукта

Дисплеен модул

– Ambu aView и aView 2 Advance.

Ендоскопски аксесоари

– Аксесоари със стандартен 6% интродюсер (Luer Slip) и/или Luer Lock

(конусно със заключване).

Ендотрахеални тръби (ETT) и тръби с двоен лумен (DLT)

– Трахеални тръби за използване в анестетични и респираторни оборудвания, които са в

съответствие с EN ISO 5361.

20

Устройството aScope 4 Broncho Sampler Set е оценено като съвместимо за посочените по-долу

размери ендотрахеални тръби (ETT), тръби с двоен лумен (DLT) и ендоскопски аксесоари (ЕА).

Минимален

вътрешен диа-

метър на ETT

Минимален

размер на

DLT

Минимална ширина

на работния канал

на ЕА

aScope 4 Broncho Regular

aScope 4 Broncho Large

6,0 mm

7,0 mm

41 Fr До 2,0 mm

До 2,6 mm

Сукционно оборудване

– Сукционна тръба с диаметър между 6,5 mm и 9,5 mm.

Контейнери за проби

– Ambu® aScope BronchoSampler™ 60 SC.

2.3. Части На aScope 4 Broncho Sampler Set

3

4

5

12

7

6

8

9

10

11

12 19

C

B15

17

18

16

20

24

23 22 21

D

A

13

14

Елемент Функция

AaScope 4 Broncho Гъвкав ендоскоп, предназначен за ендоскопски

процедури и изследвания в дихателните пътища

и трахеобронхиалното дърво.

№ Част Функция

1Дръжка Подходяща за използване както с дясна, така и с

лява ръка.

2Лост за управление Движи дисталния връх нагоре или надолу

в една равнина.

3Порт на работен канал Дава възможност за вливане на течности и

поставяне на ендоскопски аксесоари.

-Работен канал Може да се използва за вливане на течности,

сукция и въвеждане на ендоскопски аксесоари.

4Сукционен конектор Позволява свързване на сукционна тръба.

Pagina se încarcă...

Ambu aScope™ 4 Broncho Sampler Set Instrucțiuni de utilizare

Ambu aScope™ 4 Broncho Sampler Set Instrucțiuni de utilizare

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