Ambu aScope™ 5 Broncho Sampler Set Návod na používanie

Typ
Návod na používanie
For use by trained healthcare professionals only.
For use in hospital environments.
For use with Ambu® displaying units.
aScope5Broncho 4.2/2.2
Ambu® aScope 5 Broncho
Sampler Set (part 1 of 2)
INSTRUCTIONS
FOR USE
2.2
2.2
2.2
2.2
2.2
2.2
89
2a 2b
2.2
2.2
2.2
2.2
3a
5a 5c 5d
1a 1b 1c
4
10a 10b 11
2.2
5b
6a 6c6b
7a 7c7b
5f
2.2
7d
3b
2.2
2.2
5e
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CONTENTS PAGE
English (Instruction for use) ..................................................................................................................................4-15
Български (Указания за ползване) ............................................................................................................... 16-29
Česky (Návod k použití) ...................................................................................................................................... 30-42
Dansk (Brugsanvisning) .......................................................................................................................................43-54
Deutsch (Bedienungsanleitung) ..................................................................................................................... 55-68
ληvıĸά (δηγίες Xρήσεως) ............................................................................................................................... 69-82
Español (Manual de instrucciones) .................................................................................................................83-96
Eesti (Kasutusjuhised) ......................................................................................................................................... 97-108
Suomi (Käyttöohje) ........................................................................................................................................... 109-121
Français (Mode d´emploi) ...............................................................................................................................122-135
Hrvatski (Upute za uporabu) ........................................................................................................................136-148
Magyar (Használati útmutató) ..................................................................................................................... 149-161
Italiano (Manuale d’uso) ..................................................................................................................................162-174
日本 (使用法) ...............................................................................................................................................175-185
Lietuviškai (Naudojimo instrukcijos) ......................................................................................................... 186-197
Latviski (Lietošanas instrukcija) ...................................................................................................................198-209
Nederlands (Gebruiksaanwijzing) ..............................................................................................................210-223
Norsk (Brukerveiledning) ...............................................................................................................................224-235
Polski (Instrukcja obsługi) ..............................................................................................................................236-249
Português (Manual de instruções) .............................................................................................................250-263
Română (Instrucţiuni de utilizare) ..............................................................................................................264-276
Slovenčina (Návod na použitie) ................................................................................................................... 277-289
Slovenšcina (Navodila za uporabo) ............................................................................................................290-301
Svenska (Instruktionshandbok) ................................................................................................................... 302-313
Türkçe (Kullanım talimatları) ......................................................................................................................... 314-325
中文(使用说明 .................................................................................................................................................326-335
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1. Important information – Read before use
Read these Instructions for use carefully before using the aScope5Broncho. 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. Before initial use of the endoscope, it is essential for operators to have received
sufficient training in clinical endoscopic techniques and to be familiar with the intended use,
indications, warnings, cautions, and contraindications mentioned in these instructions.
There is no warranty on the endoscope.
In this document endoscope refers to instructions which apply to the endoscope only
and system refers to information relevant for the aScope5Broncho and the compatible
Ambu displaying unit and accessories. Unless otherwise specified, endoscope refers to all
aScope5Broncho variants.
In this document the term aScope 5 Broncho refers to the Ambu® aScope™ 5 Broncho.
1.1. Intended use
aScope 5 Broncho is intended for endoscopic procedures and examination within the airways
and tracheobronchial tree.
aScope 5 Broncho is intended to provide visualization via a compatible Ambu displaying unit,
and to allow passing of endotherapy instruments via its working channel.
Intended patient population
Adult.
Intended use environment
For use in hospital environments.
1.2. Indications for use
The aScope 5 Broncho is intended for oral, nasal and percutaneous intubation and flexible
bronchoscopy procedures, in any clinical situation where intubation applies or in which a
clinician expects that bronchoscopy will have a substantial diagnostic or therapeutic impact.
1.3. Contraindications
None known.
1.4. Clinical benefits
Single-use application minimises the risk of cross-contamination of the patient.
1.5. Warnings and cautions
WARNINGS
1. Only to be used by healthcare professionals trained in clinical endoscopic techniques
and procedures. Failure to comply with this may result in patient injury.
2. 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.
3. In order to avoid contamination, do not use the endoscope if the product sterilisation
barrier or its packaging is damaged.
4. 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.
5. Do not use the endoscope or an endotherapy instrument if it is damaged in any way or
if any part of the functional check fails (see section 4.1.) as failure to comply may result
in patient injury.
6. In order to promptly detect events of desaturation, patients should be monitored at all
times during use.
7. If any malfunction occurs during the endoscopic procedure, stop the procedure
immediately to avoid patient injury and withdraw the endoscope.
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8. The device should not be used if adequate supplemental oxygenation cannot be provided
to the patient during the procedure. Failure to comply may result in patient desaturation.
9. Always make sure that any tube connected to the suction connector on the scope is
connected to a suction device. Secure the tubing properly on the suction connector
before suction is applied. Failure to do so may result in patient or user injury.
10. Apply a maximum vacuum of 85 kPa (638 mmHg) when suctioning. Applying too large
a vacuum may make it difficult to interrupt suctioning and may cause patient injury.
11. Always check compatibility of the scope with both airway management accessories
and endotherapy instruments. Failure to do so may result in patient injury.
12. For non-intubated patients a mouthpiece should be used when inserting the
endoscope orally to prevent the patient from biting the insertion cord and potentially
damaging her/his teeth.
13. The shape and size of the nasal cavity and its suitability for transnasal insertion may
vary from patient to patient. Individual differences in the shapes and sizes of the
patients' nasal lumens, as well as their receptivity to transnasal insertion, must be
considered prior to the procedure. Never use force during insertion or withdrawal of
the endoscope transnasally because patient injury may occur.
14. Verify that the orientation of the image is as expected and be careful to check whether
the image on the screen is a live image or a recorded image. Failure to do so will
increase the difficulty of navigation and may result in damage to mucosa or tissue.
15. Always watch the live endoscopic image on the Ambu displaying unit or external
monitor when advancing or withdrawing the endoscope, operating the bending
section or during suctioning. Failure to do so may result in damage to mucosa or tissue.
16. Ensure the biopsy valve and its cap are properly attached prior to suction. During
manual suction, ensure that the syringe tip is fully inserted into the working channel
port/biopsy valve prior to suction. Failure to do so may expose unprotected users to
the risk of infection.
17. The endoscope images must not be used as an independent means of diagnosis for
any clinical finding. Healthcare professionals must interpret and substantiate any
finding by other means and in the light of the patient's clinical characteristics. Failure
to do so may result in delayed, incomplete, or inadequate diagnosis.
18. Always make sure that the bending section is in a straight position when inserting or
withdrawing an endotherapy instrument into or out of 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.
19. Do not damage the insertion portion during use. This may expose sharp surfaces that
may cause damage to the mucosa or this may result in parts of the product being left
inside the patient. Particular care should be taken to avoid damaging the insertion
portion when using the endoscope with endotherapy instruments.
20. Bronchoscopists and assistants shall be familiar with the adequate personal protective
equipment for bronchoscopy procedures in order to avoid contamination of staff.
21. Do not activate an endotherapy instrument in the endoscope before the instrument's
distal end can be seen in the image on the displaying unit, as this can lead to patient
injury or damage the endoscope.
22. The distal end 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 this may cause injury to mucosa.
23. When inserting or withdrawing the endoscope, the distal tip must be in a non-
deflected position. Do not operate the control lever, as this may result in injury to the
patient and/or damage to the endoscope.
24. Always perform a visual check according to the instructions in this Instructions for use
before placing the endoscope in a waste container to minimize the risk of post
procedure complications.
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25. The user must exercise professional judgement when deciding whether a
bronchoscopy procedure will be appropriate for patients with severe heart disease
(e.g. life-threatening arrythmia and recent myocardial infarction) or acute respiratory
failure with hypercapnia. Uncorrected coagulopathy is relevant if transbronchial
biopsy is planned. Serious complications have a higher rate in the mentioned
categories of patients.
26. Use of endotherapy instruments including cryo probe may in rare cases cause gas
embolism. Monitor the patient appropriately during and after treatment.
27. Patient leakage currents may be additive when using active endotherapy instruments.
Active endotherapy instruments must be classified as "type CF" or "type BF" according
to IEC 60601. Failure to comply may lead to too high patient leakage current and
patient injury.
28. Endotherapy instruments shall always be operated according to the respective
manufacturer's Instructions for use. Users shall always be familiar with safety precautions
and guidelines on the proper use of endotherapy instruments, including use of adequate
personal protective equipment. Failure to do so may result in patient or user injury.
29. Always operate endoscope and displaying unit according to the Instructions for use for
each product. Failure to do so may result in patient or user injury.
30. Do not use laser or high frequency endotherapy instruments (such as APC probe, hot
snare, hot forceps, etc) with aScope 5 Broncho 4.2/2.2 as it is not compatible. Failure to
comply may result in patient injury.
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 endoscope in combination with sharp endotherapy
instruments such as needles.
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 endoscope. The lens surface of the distal tip is
fragile and visual distortion may occur.
4. Do not exert excessive force on the bending section as this may result in damage to
the endoscope. Examples of inappropriate handling of the bending section include:
Manual twisting.
Operating it inside an ET tube 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. Keep the endoscope handle dry during preparation and use, as liquids entering the
endoscope handle may cause camera malfunction.
6. Do not use a knife or other sharp instrument to open the pouch or cardboard box,
as this may lead to sharp edges on product or product malfunction.
7. Do not remove the suction button for any reason as this may result in damage to the
endoscope and loss of suction.
8. Only use the endoscope with medical electrical equipment that complies with
IEC 60601-1, any associated applicable collateral and particular standards, or equivalent
safety standards. Failure to do so may lead to equipment damage.
1.6. 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, fever/infection,
and respiratory/cardiac arrest.
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.
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2. System description
The aScope5Broncho must be connected to an Ambu displaying unit. For information about
Ambu displaying units, please refer to the respective displaying units' Instructions for use.
2.1. System parts
Ambu® aScope™ 5 Broncho
– Single-use device:
Part numbers:
60 cm/ 23.6”
620001000 aScope 5 Broncho 4.2/2.2
aScope 5 Broncho 4.2/2.2 are not available in all countries. Please contact your local sales office.
Product name Outer diameter [mm] " Inner diameter [mm] "
aScope 5 Broncho 4.2/2.2 4.2 mm/0.17"
max 4.8 mm/0.19"
2.2 mm/0.09"
2.2. Product compatibility
The aScope5Broncho has been designed to be used in conjunction with:
Displaying units
– Ambu® aBox™ 2
– Ambu® aView™ 2 Advance
Note: Connector port colour and geometry on the displaying unit must match the connector colour and
geometry on the visualization device.
Endoscopic accessories
Passive endotherapy instruments compatible with the working channel ID (such as biopsy
forceps, cytology brushes, endoscopic needles)
Active endotherapy instruments compatible with the working channel ID (such as cryo probe)*
Accessories with standard Luer slip and/or Luer Lock (using the enclosed introducer)
*
aScope 5 Broncho 4.2/2.2 are not compatible with high frequency endotherapy instruments and laser.
Lubricants and solutions
– Sterile water
– Isotonic saline solution
– Waterbased lubricants
– Noradrenaline 0.5 mg
– Local anaesthetic gel and solutions e.g:
1 % lidocaine solution
2 % lidocaine gel
Lidocaine 10 % aerosol spray
Airway management accessories in compliance with EN ISO 5361
– Endotracheal tubes
– Laryngeal masks
– Tracheostomy tubes
– Laryngectomy tubes
– Double-swivel catheter mounts
The aScope5Broncho has been evaluated to be compatible with the following endotracheal
tubes (ETT) and endotherapy instruments (EI) sizes:
Minimum ETT
inner diameter
EI compatible with
a working channel of
aScope 5 Broncho 4.2/2.2 5.0 mm 2.2 mm
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There is no guarantee that instruments selected solely using this working channel size will be
compatible in combination. Compatibility of selected instruments should be tested before
the procedure.
Suctioning equipment
– Suction tube of inner diameters between 5.5 mm and 9.0 mm.
2.3. aScope5Bronchoparts
16
15
14
13
17
1
8
9
10
11
12
3
4
2
5
6
7
No. Part Function
1Handle Designed for left and right hand.
2Control lever Moves the distal tip up or down in a single plane.
3
Working channel port Allows for instillation of fluids and insertion of
endotherapy instruments.
Working channel Can be used for instillation/aspiration of fluids and
insertion of endotherapy instruments.
4Biopsy Valve
Attached to the working channel port. Endotherapy
instruments can be inserted or a syringe can be attached.
5Suction connector Allows for connection of suction tubing.
6Suction button Suction when pressed.
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No. Part Function
7Endoscope buttons 1 & 2
Depending on settings in Ambu displaying unit the
two remote switches allow for direct activation on
handle of four different functionalities such as image
and video capturing, ARC, zoom.
8Rotation control ring
Allows for rotation of the insertion cord during procedure.
9Tube connection Allows for fixation of tubes with standard connector
during procedure.
10 Insertion cord Flexible airway insertion cord.
Insertion portion Same as insertion cord.
11 Bending section Manoeuvrable part.
12 Distal tip Contains the camera, light source (two LEDs), as well as
the working channel exit.
13
Displaying unit connector
Connects to the connector port on the Ambu
displaying unit.
14 Cable Transmits the image signal to the Ambu displaying unit.
15 Protective handle cover Protects the control lever during transport
and storage. Remove before use.
16 Protective pipe Protects the insertion cord during transport
and storage. Remove before use.
17 Introducer To facilitate introduction of Luer Lock syringes.
3. Explanation of symbols used
Symbols for the
aScope5Broncho
devices
Description Symbols for the
aScope5Broncho
devices
Description
60 cm/ 23.6”
Working length of
the insertion cord. Temperature limit.
Max OD
Maximum insertion
portion width
(Maximum outer
diameter).
Warning.
Min ID
Minimum working
channel width
(Minimum inner
diameter).
IFU symbol.
Field of view. Global Trade
Item Number.
Humidity limitation. Packaging level
ensuring sterility.
Atmospheric
pressure limitation.
Do not use if the
product sterilisation
barrier or its
packaging is
damaged.
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Symbols for the
aScope5Broncho
devices
Description Symbols for the
aScope5Broncho
devices
Description
Electrical Safety Type
BF Applied Part. Medical Device.
Country of
manufacture:
Made in Malaysia.
UL Recognized
Component Mark
for Canada and the
United States.
UK Conformity
Assessed.
Importer
(For products
imported into
Great Britain only).
UK Responsible Person.
A full list of symbol explanations can be found on ambu.com/symbol-explanation.
4. Use of aScope5Broncho
Numbers in gray circles below refer to illustrations on page 2.
4.1. Preparation and inspection of aScope5Broncho
Lubricate the insertion cord with a water-based medical grade lubricant, to ensure the lowest
possible friction when the endoscope is inserted into the patient.
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
4. Turn on the Ambu displaying unit. 2a 2b
Refer to the Ambu displaying unit Instructions for use for preparation and inspection
of the Ambu displaying unit. 2a 2b
Inspection of the image
1. Plug in the displaying unit connector into the corresponding connector on the
compatible displaying unit. Please ensure the colours are identical and be careful
to align the arrows. 3a 3b
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 Ambu
displaying unit Instructions for use).
4. If the object cannot be seen clearly, wipe the lens at the distal tip with a sterile cloth.
Preparation of aScope5Broncho
1. Carefully slide the control lever upwards and downwards 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. 5a
2. Carefully turn the rotation control ring left and right to rotate the insertion cord as much as
possible. Then turn the rotation control ring back to its neutral position. Confirm that the
rotation control ring functions smoothly and correctly. 5b
3. Press the endoscope buttons one after the other. Short press <1 second and long press
>1second. For default setting please see displaying unit Instructions for use. 5c
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4. Instill 2 ml of sterile water and 2 ml of air into the working channel using a syringe
(if applying a Luer Lock syringe, use the enclosed introducer). Press the plunger to ensure
that there are no leaks, and that water is emitted from the distal tip. 5d
5. If applicable, prepare the suction equipment according to the manufacturer’s Instructions
for use. Connect the suctioning tube to the suction connector and press the suction
button to check that suction is applied. 5e
6. If applicable, verify that endotherapy instruments of appropriate size can be passed
through the working channel without resistance. The enclosed introducer can be used for
connection of Luer Lock syringes or to ease insertion of very soft instruments such as soft
catheters and protected specimen brushes if necessary. 5f
7. If applicable, verify that the accessories or endotherapy instruments are compatible with
the endoscope before starting the procedure.
8. To guard against potentially infectious materials during the procedure, consider wearing
personal protective equipment.
4.2. Operating the aScope5Broncho
Holding the aScope5Bronchoand manipulating the tip
The handle of the endoscope can be held with either hand.
Use the thumb to move the control lever up and down 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 plane 5a . 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 bending
angle at the distal tip. After bending, the control lever should be moved back to neutral
position. This will increase/ease maneuverability.
Rotation of the insertion cord 5b
The rotation control ring enables the user to rotate insertion cord in relation to the handle, and
vice-versa. This can be done either by holding the rotation control ring in place and then
rotating the handle, or by holding the handle in place and then rotating the rotation control
ring. In either case, make sure to check the rotation indicators on the rotation control ring and
on the red ring above. The rotation is at neutral position (i.e. turned 0°) when the indicators are
aligned, this will allow a maximal rotation of 120° to either side. There is a tactile click
indicating when the rotation control ring is returned to the neutral position. Always view the
live endoscopic image when operating the rotation control ring to avoid patient injury.
Endoscope buttons 5c 6a
The two endoscope buttons can activate up to four functions.
The endoscope buttons can be programmed via the Ambu displaying unit (see Instructions for
use of the Ambu Displaying Unit) and current settings can be found in the user interface of the
Ambu displaying unit.
During use of active endotherapy instruments the endoscope buttons cannot be activated on
the handle but functions are still available using the Ambu displaying unit.
Biopsy valve 6b
The biopsy valve is attached to the working channel port allowing for insertion of endotherapy
instruments or attachment of syringes.
The cap of the biopsy valve can be detached to ease insertion of an endotherapy instrument
or accessory into the instrument channel port.
If not using an endotherapy instrument or accessory, always attach the cap to the biopsy
valve to avoid leakage and spraying of fluids from the open biopsy valve or reduction of
suction capability.
Tube connection 6c
The tube connection can be used to mount ETT with an ISO connector during intubation.
Insertion of the endoscope 7a
Lubricate the insertion cord with a water-based medical grade lubricant when the endoscope
11
is inserted into the patient. If the endoscopic image 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 patient and the endoscope from being damaged.
Instillation of fluids 7b
Fluids can be instilled through the working channel by attaching a syringe to the biopsy valve.
When using a Luer Lock syringe, use the included introducer. Insert the syringe tip or the
introducer completely into the biopsy valve (with or without the valve's cap attached) 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.
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 endotherapy instruments or accessories 7d
Always make sure to select the correct size endotherapy instrument for the endoscope
(see section 2.2). Maximum compatible instrument size is indicated at the working channel port.
Inspect the endotherapy instrument before using it. If there is any irregularity in its operation or
external appearance, replace it. Insert the instrument into the biopsy valve and advance it
carefully through the working channel until it can be seen on the endoscopic image.
For insertion, hold the endotherapy instrument close to the opening of the biopsy valve and
insert it straight into the opening using gentle short strokes to avoid the endotherapy
instrument to bend or break. The enclosed introducer can be used to ease insertion of very
soft instruments such as soft catheters and protected specimen brushes if necessary. Use of
excessive force during insertion may damage the endotherapy instrument. When the bending
section of the endoscope angulates significantly and insertion of the endotherapy instrument
becomes difficult, straighten the bending section as much as possible.
Do not open the tip of the endotherapy instrument or extend the tip of the endotherapy
instrument from its sheath while the instrument is in the working channel, as this may damage
both the endotherapy instrument and the endoscope.
Insertion of active endotherapy instruments 7d
Use of active endotherapy instruments should always be operated according to the respective
manufacturer's instructions for use. Users shall always be familiar with safety precautions and
guidelines on the proper use of active endotherapy instruments, including use of adequate
personal protective equipment.
Do not activate an endotherapy instrument in the working channel before the instrument
distal end can be seen in the image.
It should be recognized that the use of active endotherapy instruments may interfere with
the normal endoscopic image and this interference is not indicative of a malfunction of
the endoscopic system. A variety of factors can affect the quality of the endoscopic image
during use of active endotherapy instruments. Factors such as intensity, high power setting,
close distance of the instrument probe to the endoscope tip and excessive tissue burning
can each adversely influence image quality.
Withdrawal of the endoscope 8
When withdrawing the endoscope, make sure that the control lever is in the neutral position.
Slowly withdraw the endoscope while watching the live endoscopic image.
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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.
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.
Disconnect
Disconnect the endoscope from the displaying unit 10 . The aScope5Broncho is a single-use
device. Do not soak rinse, or sterilize this device as these procedures may leave harmful
residues or cause malfunction of the device. The design and materials used are not compatible
with conventional cleaning and sterilization procedures.
Disposal 11
The used aScope5Broncho is considered contaminated after use and must be disposed
of in accordance with local guidelines for collection of infected medical devices with
electronic components.
5. Technical product specifications
5.1. Standards applied
The endoscope 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.
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.
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5Bronchospecifications
Insertion cord aScope 5 Broncho 4.2/2.2
Bending section1 [°] 210 , 210
Insertion cord diameter [mm, (”)]
4.2 (0.17)
Maximum diameter of insertion portion [mm, (”)] 4.8 (0.19)
Distal tip diameter [mm, (”)] 4.4 (0.17)
Minimum endotracheal tube size (ID) [mm] 5.0
Working length [mm, (”)] 600 (23.6) ± 10 (0.39)
Rotary function [°] 120
Depth marks [cm] 5
Working channel aScope 5 Broncho 4.2/2.2
Instrument channel width2 [mm, ()]
Minimum instrument channel width2 [mm, (”)]
2.2 (0.09)
2.2 (0.09)
13
Storage aScope 5 Broncho 4.2/2.2
Recommended storage temperature3 [°C, (°F)] 10 – 25 (50 – 77)
Relative humidity [%] 10 – 85
Atmospheric pressure [kPa] 50 – 106
Optical system aScope 5 Broncho 4.2/2.2
Field of view [°] 120 (± 15 %)
Direction of view [°] 0 (forward viewing)
Depth of field [mm] 3 – 100
Illumination method LED
Suction connector
Connecting tube ID [mm] Ø 5.5 – 9.0
Sterilisation aScope 5 Broncho 4.2/2.2
Method of sterilisation ETO
Operating environment aScope 5 Broncho 4.2/2.2
Temperature [°C, (°F)] 10 – 40 (50 – 104)
Relative humidity [%] 30 – 85
Atmospheric pressure [kPa] 80 – 106
Altitude [m] ≤ 2000
Biocompatibility aScope5Broncho is biocompatible
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 endotherapy instruments selected solely using this minimum
instrument channel width will be compatible in combination.
3. Storage under higher temperatures may impact shelf life.
6. Troubleshooting
If problems occur with the system, please use this trouble shooting guide to identify the cause
and correct the error.
14
en
Problem Possible cause Recommended action
No live image on
the screen but
User Interface is
present on the
display or the
image shown
is frozen.
The endoscope is not con-
nected to the displaying unit.
Connect the endoscope to the green
port on the displaying unit.
The displaying unit and the
endoscope have
communication problems.
1. Reconnect aScope5Broncho by
unplugging and reconnecting
the endoscope.
2. Turn off the displaying unit and turn
it on again (Power off/Power on).
Still no image;
3. Refer to the Instructions for use
of the displaying unit for a detailed
troubleshooting guide or alternative-
ly take a new endoscope.
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 capability
or difficulty in
inserting
endotherapy
instrument
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 is not active. Ensure the suction tube is properly
connected to the endoscope and to the
suction system. Ensure suction system
is turned on.
Endotherapy instrument/
introducer/syringe inserted
in working channel port/
biopsy valve (applicable if
suction is absent or reduced).
Remove endotherapy instrument or
introducer/syringe from the working
channel port/biopsy valve. Check that
the instrument used is compatible with
the working channel's ID.
Cap detached
from biopsy valve.
Ensure that the cap is attached
to the biopsy valve to avoid
reduction of suction capability.
Biopsy valve. Difficulty inserting
an endotherapy instrument
through the working
channel.
Ensure compatibility of endotherapy
instrument to working channel size.
When the cap of the biopsy valve is
detached, it may be easier to insert an
endotherapy instrument into the
instrument channel port.
Endoscope
buttons.
The setting of the
endoscope buttons differs
from preferred setting.
Set the endoscope button function as
preferred using the Instructions for use
for the displaying unit.
Suction button. Suction button detached
from endoscope.
Remount suction button and test
the suction function according to
preparation step 5e . If that does not
work, then use new endoscope.
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1. Важна информация – Прочетете преди употреба
Прочетете внимателно тези инструкции за употреба, преди да използвате aScope5Broncho.
Инструкциите за употреба може да се актуализират без допълнително уведомление.
Копия на текущата версия са налични при поискване. Имайте предвид, че тези инструкции
не дават обяснения и не разглеждат клиничните процедури. Те описват само базовите
операции и предпазните мерки, свързани с работата с ендоскопа. Преди употребата на
ендоскопа е важно операторите да са получили подходящо обучение за клиничните
ендоскопски техники и да са запознати с предназначението, показанията, предупрежденията,
предпазните мерки и противопоказанията, отбелязани в тези инструкции.
Няма гаранция за ендоскопа.
В настоящия документ определението ендоскоп се използва в инструкциите, които са
приложими само за самия ендоскоп, a система – за информацията, отнасяща се за
aScope5Broncho, съвместимия дисплеен модул Ambu и аксесоарите. Освен ако не е
посочено друго, „ендоскоп“ се отнася за всички варианти на aScope5Broncho.
В настоящия документ терминът aScope 5 Broncho се отнася за Ambu® aScope™ 5 Broncho.
1.1. Предназначение
aScope 5 Broncho е предназначен за ендоскопски процедури и изследвания в дихателните
пътища и трахеобронхиалното дърво.
aScope 5 Broncho е предназначен за визуализация чрез съвместим дисплеен модул Ambu,
както и за прокарване на инструменти за ендотерапия през своя работен канал.
Целева пациентска популация
Възрастни.
Предвидена среда на употреба
За употреба в болнична среда.
1.2. Показания за употреба
aScope 5 Broncho е предназначен за орална, назална и перкутанна интубация и процедури
с гъвкава бронхоскопия във всяка клинична ситуация, в която се интубира или в която
медицинският специалист очаква, че бронхоскопията ще има значително диагностично
или терапевтично въздействие.
1.3. Противопоказания
Не са известни.
1.4. Клинични ползи
Приложението за еднократна употреба минимизира риска от кръстосана контаминация
на пациента.
1.5. Предупреждения и указания за внимание
ПРЕДУПРЕЖДЕНИЯ
1. Да се използва само от здравни специалисти, обучени за клиничните ендоскопски
техники и процедури. Неспазването на това указание може да доведе до
нараняване на пациента.
2. 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.
3. За да предотвратите контаминация, не използвайте ендоскопа, ако
стерилизационната бариера на продукта или опаковката му е увредена.
4. 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.
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5. Не използвайте ендоскопа или инструмента за ендотерапия, ако са повредени
по някакъв начин или ако някоя част от функционалната проверка е неуспешна
(вижте раздел 4.1.) – неспазването на указанията може да доведе до нараняване
напациента.
6. За да се открият своевременно събития на десатурация, пациентите трябва да
бъдат наблюдавани постоянно по време на употреба.
7. Ако по време на ендоскопската процедура възникне неизправност, незабавно
прекратете процедурата, за да предотвратите нараняване на пациента, и
изтеглете ендоскопа.
8. Изделието не трябва да се използва, ако по време на процедурата на пациента
не може да му се осигури адекватна допълнителна оксигенация. Неспазването
на това указание може да доведе до десатурация на пациента.
9. Винаги се уверявайте, че тръбата, свързана към сукционния конектор на ендоскопа,
задължително трябва да е свързана към сукционно устройство. Укрепете тръбата
по подходящ начин към сукционния конектор преди сукция. Неизпълнението на
това указание може да доведе до нараняване на пациента или потребителя.
10. По време на сукция прилагайте вакуум макс. 85kPa (638mmHg). Прилагането на
твърде голям вакуум може да доведе до затруднения в прекратяването на
сукцията и респективно до нараняване на пациента.
11. Винаги проверявайте съвместимостта на ендоскопа както с аксесоарите за
обезпечаване на проходимостта на дихателните пътища, така и с инструментите
заендотерапия. Неизпълнението на това указание може да доведе до нараняване
на пациента.
12. За неинтубирани пациенти трябва да се използва мундщук при въвеждане на
ендоскопа през устата, за да се предотврати захапването на въвеждащия шнур
и потенциалното му увреждане от зъбите на пациента.
13. Формата и размерът на назалната кухина, както и нейната пригодност за
трансназално въвеждане, може да варират при различните пациенти. Преди
процедурата трябва да се вземат предвид индивидуалните различия във формата
и размера на назалните лумени на пациентите, както и тяхната възприемчивост
към трансназално въвеждане. В никакъв случай не прилагайте сила при
трансназално въвеждане или изтегляне на ендоскопа, тъй като това може да
причини нараняване на пациента.
14. Уверете се, че ориентацията на изображението е правилна, и не забравяйте да
проверите дали изображението на екрана е изображение в реално време, или е
записано изображение. Неизпълнението на това указание ще повиши трудността
на управлението и може да доведе до увреждане на лигавицата или тъканта.
15. Постоянно следете ендоскопското изображение в реално време на дисплейния
модул Ambu или на външен монитор по време на вкарване или изтегляне на
ендоскопа, както и при работа с гъвкавата част или сукцията. Неизпълнението на
това указание може да доведе до увреждане на лигавицата или тъканта.
16. Уверете се, че клапанът за биопсия и неговата капачка са правилно закрепени
преди сукцията. За ръчна сукция: уверете се, че върхът на спринцовката е вкаран
докрай в порта на работния канал/клапана за биопсия преди сукция.
Неизпълнението на това указание може да изложи незащитените потребители на
риск от инфекция.
17. Ендоскопските изображения не трябва да се използват като независимо средство
за диагностика при каквато и да е клинична находка. Здравните специалисти
трябва да тълкуват и обосновават всяка находка с други средства и съгласно
клиничните характеристики на пациента. Неизпълнението на това указание може
да доведе до забавена, непълна или неадекватна диагноза.
18. Задължително се уверявайте, че гъвкавата секция е в изправено положение,
когато въвеждате или изтегляте инструмент за ендотерапия в или от 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.
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19. Не увреждайте частта за въвеждане по време на употреба. Това може да доведе
до разкриване на остри повърхности, които могат да наранят лигавицата, или да
останат части от продукта вътре в пациента. Особено трябва да се внимава да се
избегне увреждане на въвежданата част, когато ендоскопът се използва с
инструменти за ендотерапия.
20. Бронхоскопистите и асистентите трябва да са запознати с подходящите лични
предпазни средства за бронхоскопични процедури, за да се избегне
контаминиране на персонала.
21. Не активирайте инструмент за ендотерапия в ендоскопа, преди дисталният край
на инструмента да може да се види на изображението на дисплейния модул, тъй
като това може да доведе до нараняване на пациента или повреда на ендоскопа.
22. Дисталният край на ендоскопа може да се загрее поради топлината от излъчващата
светлина част. Избягвайте продължителния контакт между дисталния връх и
лигавичната мембрана, тъй като това може да причини нараняване на лигавицата.
23. При вкарване или изтегляне на ендоскопа дисталният връх трябва да бъде в
ненаклонено положение. Не работете с лоста за управление, тъй като това може
да доведе до нараняване на пациента и/или повреда на ендоскопа.
24. Задължително извършвайте визуална проверка в съответствие с указанията в
настоящите инструкции за употреба, преди да оставите ендоскопа в контейнер
за отпадъци, за да се минимизира рискът от усложнения след процедурата.
25. Потребителят трябва да направи професионална преценка при вземането на
решение дали процедурата по бронхоскопия ще бъде подходяща за пациенти
с тежко сърдечно заболяване (напр. животозастрашаваща аритмия и скорошен
инфаркт на миокарда) или с остра дихателна недостатъчност с хиперкапния.
Некоригирана коагулопатия е целесъобразна, ако се планира трансбронхиална
биопсия. Посочените категории пациенти имат по-висока степен на сериозни
усложнения.
26. Използването на инструменти за ендотерапия, включително криосонда, в редки
случаи може да причини газова емболия. Наблюдавайте пациента по подходящ
начин по време на и след лечението.
27. Токът от утечки към пациента може да е кумулативен, когато се използват активни
инструменти за ендотерапия. Активните инструменти за ендотерапия трябва да се
класифицират като „тип CF“ или „тип BF“ в съответствие с IEC60601. Неспазването
на това указание може да доведе до твърде висок ток от утечка към пациента и
нараняване на пациента.
28. Инструментите за ендотерапия трябва винаги да се използват в съответствие с
инструкциите за употреба на съответния производител. Потребителите трябва
да са запознати с мерките за безопасност и указанията за правилна употреба на
инструментите за ендотерапия, включително използването на подходящи лични
предпазни средства. Неизпълнението на това указание може да доведе до
нараняване на пациента или потребителя.
29. Винаги работете с ендоскопа и дисплейния модул в съответствие с инструкциите
за употреба на всеки продукт. Неизпълнението на това указание може да доведе
до нараняване на пациента или потребителя.
30. Не използвайте лазерни или високочестотни инструменти за ендотерапия (като
например сонда за APC, гореща примка, горещ форцепс и т.н.) с aScope 5 Broncho
4.2/2.2, тъй като не са съвместими. Неспазването на това указание може да доведе
до нараняване на пациента.
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ПРЕДПАЗНИ МЕРКИ
1. Осигурете на разположение подходяща резервна система за незабавна употреба,
така че процедурата да може да продължи, ако възникне неизправност.
2. Внимавайте да не повредите ендоскопа в комбинация с остри инструменти за
ендотерапия, като например игли.
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 ендоскопа.
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 ендоскопа. Примери за неправилно боравене с гъвкавата
секция включват:
Ръчно усукване.
Работа с нея в ET тръба 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. Поддържайте дръжката на ендоскопа суха по време на подготовката и употребата,
тъй като течности, които влязат в дръжката на ендоскопа, могат да доведат до
неизправност на камерата.
6. Не използвайте нож или друг остър инструмент за отваряне на торбичката или на
картонената кутия, тъй като това може да доведе до остри ръбове върху продукта
или повреда на продукта.
7. Не сваляйте бутона за сукция по каквато и да е причина, тъй като това може да
доведе до повреда на ендоскопа и загуба на вакуум.
8. Използвайте ендоскопа само с електромедицински апарати, които отговарят на
IEC 60601-1, на други приложими допълващи и специфични стандарти или на
еквивалентни стандарти за безопасност. Неизпълнението на това указание може
да доведе до повреда на оборудването.
1.6. 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, пирексия/инфекция и респираторен/сърдечен арест.
1.7. 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5Broncho трябва да бъде свързан към дисплеен модул Ambu. За информация
относно дисплейните модули Ambu вижте техните инструкции за употреба.
2.1. Части на системата
Ambu® aScope™ 5 Broncho –
изделие за еднократна употреба:
Номера на части:
60 cm/ 23.6”
620001000 aScope 5 Broncho 4.2/2.2
aScope 5 Broncho 4.2/2.2 не се предлагат във всички държави. Свържете се с местния
търговски офис.
19
Име на продукта Външен диаметър
[mm] "
Вътрешен диаметър
[mm] "
aScope 5 Broncho 4.2/2.2 4,2 mm/0,17"
макс. 4,8 mm/0,19"
2,2 mm/0,09"
2.2. Съвместимост на продукта
aScope5Broncho е предназначен да се използва в комбинация с:
Дисплейни модули
– Ambu® aBox™ 2
– Ambu® aView™ 2 Advance
Забележка: Цветът и геометрията на конекторния порт на дисплейния модул трябва да съответстват на
цвета и геометрията на конектора на устройството за визуализиране.
Ендоскопски аксесоари
Пасивни инструменти за ендотерапия, съвместими с в.д. на работния канал
(например биопсични форцепси, цитологични четки, ендоскопски игли)
Активни инструменти за ендотерапия, съвместими с в.д. на работния канал
(като например криосонда)*
Аксесоари със стандартен луер слип и/или луер лок (чрез използване на приложения
интродюсер)
* aScope 5 Broncho 4.2/2.2 не са съвместими с високочестотни инструменти за ендотерапия и лазер.
Лубриканти и разтвори
– Стерилна вода
– Изотоничен физиологичен разтвор
– Лубриканти на водна основа
– Норадреналин 0,5mg
– Локален анестетичен гел и разтвори, например:
1 % разтвор на лидокаин
2 % лидокаинов гел
Лидокаин 10 % аерозолен спрей
Аксесоари за обезпечаване на проходимостта на дихателните пътища в
съответствие с EN ISO 5361
– Ендотрахеални тръби
– Ларингеални маски
– Трахеостомни тръби
– Ларингектомични тръби
– Двойно въртящи се стойки за катетър
aScope5Broncho е оценен като съвместим с ендотрахеални тръби (ETT) и инструменти за
ендотерапия (EI) с посочените по-долу размери:
Минимален вътрешен
диаметър на ETT
EI, съвместими с
работен канал на
aScope 5 Broncho 4.2/2.2 5,0 mm 2,2 mm
Няма гаранция, че инструментите, избрани единствено чрез използване на този размер
на работния канал, ще бъдат съвместими в комбинация. Съвместимостта на избраните
инструменти трябва да се тества преди процедурата.
Сукционно оборудване
– Сукционна тръба с диаметър между 5,5mm и 9,0mm.
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Ambu aScope™ 5 Broncho Sampler Set Návod na používanie

Typ
Návod na používanie