Ambu aScope BronchoSampler User manual

Instruction for Use
Ambu® aScope BronchoSampler™
For use with Ambu® aScope™4 Broncho.

IVD Pat. Pending
Ambu is a registered trademark and aScope BronchoSampler is trademark of Ambu A/S.
8 9
7
2 31
4 65
2

3
Contents Page
English (Instruction for Use)................................................................................04-09
 (  ).......................................................................10-15
Čeština (návod k použití) ....................................................................................16-21
Dansk (Brugsanvisning)......................................................................................22-27
Deutsch (Bedienungsanleitung) ............................................................................ 28-33
Ελληνικά (Οδηγίε χρήση) ................................................................................. 34-39
Español (Instrucciones de uso)..............................................................................40-45
Eesti (Kasutusjuhend)....................................................................................... 46-51
Käyttöohje (suomi) ..........................................................................................52-57
Français (Mode d’emploi)...................................................................................58-63
Hrvatski (Upute za upotrebu)...............................................................................64-69
Magyar (Használati útmutató) ...............................................................................70-75
Inglese (Istruzioni per l’uso)................................................................................. 76-81
英 語（ 使 用 説 明 書 ） .........................................................................................82-87
Lietuvių (naudojimo instrukcija) ............................................................................ 88-93
Latviešu val. (Lietošanas instrukcija).........................................................................94-99
Nederlands (Gebruiksaanwijzing).........................................................................100-105
Norsk (Bruksanvisning) ....................................................................................106 -111
Angielski (Instrukcja użytkowania) .........................................................................112-117
Português (Instruções de utilização) .......................................................................118-123
Română (Instruciuni de utilizare)......................................................................... 124-129
 (  ) .................................................................. 130-135
Slovensky (Návod na použitie) ............................................................................ 136-141
Slovenščina (Navodila za uporabo).........................................................................142-147
Svenska (bruksanvisning)................................................................................. 148-153
Türkçe (Kullanma Talmatı)................................................................................ 154-159
中 文（ 使 用 说 明 ） .........................................................................................160-165

1. Important Information – read before use
Read these safety instructions carefully before using the aScope BronchoSampler™. The Instruction 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 pre-
cautions related to the operation of the aScope BronchoSampler™. Before initial use of the aScope
BronchoSampler™, it is essential for operators to have received sufficient training in clinical endoscopic techniques
and to be familiar with the intended use, cautions and indications mentioned in these instructions.
1.1. Intended Use
aScope BronchoSampler™ is a sterile single-use device designed as an add-on to aScope™ 4 Broncho during a
Broncho Alveolar Lavage (BAL) or Bronchial Wash (BW) procedure. aScope BronchoSampler™ is in combination
with an aScope 4 Broncho device designed to enable aspiration and collection a fluid sample(s) from the bron-
chial or alveolar part of the lung.
1.2. Indications for Use
aScope BronchoSampler™ is for use in a hospital environment. aScope BronchoSampler™ is a single-use
device designed for use in adults.
1.3. Cautions
Failure to observe these 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.
CAUTIONS
1. 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.
2. Only to be used by skilled professionals trained in clinical endoscopic techniques and procedures.
4

EN
2. System Description
aScope BronchoSampler™ is for use together with aScope 4 Broncho only. For information about the use of aScope 4
Broncho, please refer to the aScope 4 Broncho Instruction for Use.
2.1. System Parts
Ambu® aScope BronchoSampler™
– single use device: Part numbers:
480200000 aScope BronchoSampler™
480300000 aScope BronchoSampler™ SC
aScope BronchoSampler™ is not available in all countries. Please contact your local sales office.
Product Name Packaging configuration Sampler bridge Sample container Suction adapter
aScope
BronchoSampler™ 1 pc 2 pcs 1 pc
aScope
BronchoSampler™ SC 1 pc
Compatible devices: Ambu aScope 4 Broncho Part numbers:
aScope 4 Broncho Large 5.8/2.8 478001000
aScope 4 Broncho Regular 5.0/2.2 477001000
aScope 4 Broncho Slim 3.8/1.2* 476001000
aScope 4 Broncho Slim, aScope 4 Broncho Regular and aScope 4 Broncho Large are not available in all
countries. Please contact your local sales office.
* aScope BronchoSampler™ has limited sampling and suction performance on aScope 4 Broncho Slim.
5

2.2. aScope BronchoSampler™ parts
5
B
A1
3
4
2
6
10
987
C
Item Function
ASample container Connects to the sampler bridge and holds the retrieved sample
BSuction adapter For connection to a male suction adapter and the suction connector
CSampler bridge Connects to the aScope 4 Broncho, and creates a closed loop
for sampling and/or suctioning
No. Part Function Material
1 Flip top Acts as click-on locking mechanism for sample container.
To be pressed down anteriorly to disengage locking mechanism PP
2Sample container lid For closing and protecting the sample PP
3Connection interface For connection of sampler bridge and sample container Silicone
PP
4Sample container glass For storage of sample HIPS
No. Part Function Material
5Suction adapter For connection to a male suction adapter and
the suction connector TPE
No. Part Function Material
6Suction connector For connection of suction tubing PP
7aScope 4 Broncho
connection interface
For introduction of aScope 4 Broncho suction
connector, to establish connection
MABS
TPE
8Attachment lock Locks the sampler bridge to the aScope 4 Broncho POM
9Flow switch Determines suction flow direction and switches between
general suction and sampling POM
10 Connection interface For connection of sampler bridge and sample container MABS
Silicone
6

EN
3. Explanation of Symbols Used
Do not use if the product sterilisation
barrier or its packaging is damaged. This product is not made with PVC.
Single use product, do not reuse. This product is not made with phthalates.
Sterile Product, sterilisation by ETO. IVD
CE mark. The product complies with the
EU Council directive concerning In-Vitro
Diagnostic Medical Devices 98/79/EC.
Consult Instruction for Use. Manufacturer.
Warning. Use By, followed by YYYY-MM-DD.
10
oC
50
oF
40
o
C
10 4 oFTemperature limitation: storage
between 10-40 °C (50-104 °F). Reference Number.
This product is not made with natural
rubber latex. Lot Number.
4. Use of Product
Numbers in gray circles below refer to illustrations on page 2.
4.1. Preparation and Inspection of aScope BronchoSampler™
Visual inspection
1. Check that the packaging is intact.
Refer to the aScope 4 Broncho Instruction for Use for inspection, preparation and use of the aScope 4 Broncho.
Preparation for use of aScope BronchoSampler™ with aScope 4 Broncho
1. Carefully connect the sampler bridge with the aScope 4 Broncho, by mounting the sampler bridge
on the aScope 4 Broncho suction connector. Ensure a tight fit. 1
2. Press the attachment lock button to secure connection. 2
3. 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. 3
4. 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. 4
4.2. Operating the aScope BronchoSampler™
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. 5
2. To prepare for sampling of specimen, turn the flow switch counter-clockwise towards the sample container,
and align it horizontally. 6
3. Instillation of fluids should be performed in accordance with Instruction for Use for aScope 4 Broncho.
4. 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.
7

1. 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.
2. Remove the sample container by pressing the flip top, and pull the sample container from the sampler bridge. 7
3. 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. 8
4.3. Post Procedure
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. 9
3. Transportation and handling of sample container must be performed in accordance with local guidelines for
transportation and handling of hazardous material.
Final steps
aScope BronchoSampler™ is a single use device. aScope BronchoSampler™ is considered infected after use and
must be disposed in accordance with local guidelines for collection of infected medical devices.
5. Technical Product Specications
5.1. Standards Applied
The aScope BronchoSampler™ function conforms with:
- 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 BronchoSampler™ Specications
Suction Connector1Specification
Connecting tube with female interface. ID = Ø7 ± 1 mm
Connecting tube with male interface.
Applicable when suction adapter is used.
OD = Ø7 ± 1 mm
1. Please check for compatibility with suction tubing before use
Sample Container Specification
Sample Container volume 30 ml
Storage and transportation Specification
Storage and transportation temperature 10-40°C (50-104°F)
Operating environment Specification
Temperature 10 - 40°C (50-104°F)
Sterilisation Specification
Method of sterilisation ETO
8

EN
6. Trouble Shooting
If problems occur with the system, please use this trouble shooting guide to identify the cause and correct the error.
Problem Possible cause Recommended action
Absent or reduced suction
or sampling capability.
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 attach-
ment lock button to secure connection.
Suction pump is not turned on or
not connected.
Turn the pump on and check
the suction line 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.
9

1.   –   
     ,    aScope BronchoSampler™.
        .   
    .  ,         -
  .        ,   
 aScope BronchoSampler™.     aScope BronchoSampler™   -
               -
,    ,    .
1.1. 
aScope BronchoSampler™      ,   
 aScope™ 4 Broncho      (BAL)   
(BW). aScope BronchoSampler™     aScope 4 Broncho ,   
             .
1.2.   
aScope BronchoSampler™       . aScope BronchoSampler™ 
   ,      .
1.3.  
               .
Ambu                
   .

1.    .         
.  ,     ,    
          .
2.       ,       .
10