Ambu BronchoSampler 60 User manual

For use by trained healthcare professionals only.
For use in hospital environments.
For use with Ambu®displaying units.
Ambu® aScope™5 Broncho
Sampler Set (part 2 of 2)
INSTRUCTIONS
FOR USE

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3A
3B
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Contents Page
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1. Important information – Read before use
Read these Instructions for Use carefully before using the aScope™ 5 Broncho Sampler Set�
These instructions contain part 2 of 2 of the instructions for the use of the aScope™ 5 Broncho
Sampler Set:
•Part 1 of 2: Basic procedures using the aScope™ 5 Broncho�
•Part 2 of 2: Fluid sampling using the BronchoSampler 60 with the aScope™ 5 Broncho�
Before initial use, it is essential for operators to have received sufficient training in clinical
endoscopic techniques and to be familiar with the intended use, contraindications, warnings
and cautions mentioned in these Instructions for Use� 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�
There is no warranty on the aScope™ 5 Broncho Sampler Set�
In these Instructions for Use, the term BronchoSampler 60 refers to the closed loop fluid
sampling system to be used with the aScope™ 5 Broncho as part of the aScope™ 5 Broncho
Sampler Set� The term aScope BronchoSampler™ 60 SC refers to the sample container alone�
See section 2�1� for more information�
1.1. Intended use
aScope 5 Broncho Sampler Set enables aspiration and collection of fluid samples�
1.2. Indication for use
Bronchoscopic fluid sampling via techniques such as Broncho Alveolar Lavage (BAL) and
Bronchial Wash (BW)� The collected specimens undergo microbiological and cytological
laboratory analyses for diagnosis and/or surveillance of suspected respiratory infections,
interstitial lung diseases or lung cancer�
1.3. Contraindications
None known for fluid sampling using the BronchoSampler 60� For basic procedures using the
aScope™ 5 Broncho, please refer to the Instructions for Use part 1 of 2�
1.4. Warnings and cautions
For warnings and cautions related to the use of aScope™ 5 Broncho, please refer to the
Instructions for Use part 1 of 2�
WARNINGS
1� For single-use only� The sample container is not intended to be reprocessed or reused,
even when used on the same patient or procedure� Failure to ensure this may cause
contamination of the sample and lead to misdiagnosis�
CAUTIONS
1� Do not use the aScope BronchoSampler 60 SC in a centrifuge, as this may cause the
container to break or leak�
2� Do not transport the aScope BronchoSampler 60 SC in a pneumatic tube system,
as this may cause the container to leak�

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1.5. Potential adverse events
None known for fluid sampling using the BronchoSampler 60� For basic procedures using
the aScope™ 5 Broncho, please refer to the Instructions for Use part 1 of 2�
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 BronchoSampler 60 is designed for use in conjunction with the aScope™ 5 Broncho�
For information about the use of the aScope™ 5 Broncho, please refer to the Instructions for Use
part 1 of 2�
2.1. System parts
Item Part name Part number
60 cm/23.6”
2.2
aScope™ 5 Broncho HD 5�6/2�8
Sampler Set
aScope™ 5 Broncho HD 5�0/2�2
Sampler Set
aScope™ 5 Broncho 4�2/2�2
Sampler Set
Contains two single sample
containers, a suction adapter,
a sampler bridge and
an aScope™ 5 Broncho with
two Introducers�
622002000
621002000
620002000
aScope BronchoSampler™ 60 SC
Contains a single sample
container for collecting
additional samples during
the same procedure�
480500000
NOTE: The BronchoSampler 60 is only available as part of a set packaged with a compatible aScope™5 Broncho�
The aScope™5 Broncho Sampler Set is not available in all countries� Please contact your local Ambu representative
for more information�
2.2. Product compatibility
Compatible Ambu devices for BronchoSampler 60
• Ambu® aScope™ 5 Broncho HD 5�6/2�8
• Ambu® aScope™ 5 Broncho HD 5�0/2�2
• Ambu® aScope™ 5 Broncho 4�2/2�2
• Ambu® aScope BronchoSampler™ 60 SC
Suctioning equipment
For suction tube compatibility, see section 5�2�

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2.3. BronchoSampler 60 parts
A1
3
4
2
6
10
987
C
5
B
Function
ASample container Connects to the sampler bridge and holds
the retrieved sample�
BSuction adapter For connection between the suction connector and
a wsuction tube with male interface�
CSampler bridge Connects to the aScope™ 5 Broncho and creates
a closed loop for sampling�
No. Item A Functions Material
1Flip top A click-on locking mechanism for the sample
container� Press down to disengage the locking
mechanism�
PP
2Sample container lid For closing and protecting the sample� PP
3Connection interface For connecting the sampler bridge and
sample container�
Silicone
PP
4Sample container vial For storage of the sample� SBC
No. Item B Functions Material
5Suction adapter For connection between the suction connector
and a suction tube with male interface�
TPE
No. Item C Functions Material
6Suction connector For connection of suction tubing� PP
7aScope™ 5 Broncho
connection interface
For introduction of the aScope™ 5 Broncho
suction connector to establish connection�
MABS
TPE
8Attachment lock Locks the sampler bridge to
the aScope™ 5 Broncho�
POM
9Flow switch Determines suction flow direction� Switch
between sampling and suction mode�
POM
10 Connection interface For connecting the sampler bridge
and sample container�
MABS
Silicone
3. Explanation of symbols used
Please refer to the Instructions for Use part 1 of 2 for an explanation of the symbols used for the
aScope™ 5 Broncho Sampler Sets�

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4. Use of BronchoSampler 60
Before using the BronchoSampler 60 for the first time, follow the steps described below�
Characters in grey circles refer to the illustrations in the Quick Guide on page 2�
4.1. Preparation and inspection
Refer to the Instructions for Use part 1 of 2 for inspection, preparation and for the use of
the aScope™ 5 Broncho.
Preparation for use of the BronchoSampler 60 with aScope™ 5 Broncho.
1� Carefully con nect the sampler bridge with the aScope™ 5 Broncho, by mounting the
sampler bridge on the aScope™ 5 Broncho suction connector 1� Ensure a tight fit�
2� Push in the attachment lock to secure connection 2�
3� Carefully connect the vacuum suction tubing to the suction connector according to the
supplier’s manual 3A� If the vacuum suction tubing has a male connector, use the suction
adapter to ensure fit 3B �
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 4� Do not use preservatives in the sample container�
5� To guard against potentially infectious materials during the procedure, wear personal
protective equipment�
4.2. Operating the BronchoSampler 60
1� If suction is deemed relevant before sampling, ensure that the flow switch is aligned
vertically and pointing upwards 5� Perform suction by pressing the suction button on
the aScope™ 5 Broncho in accordance with Instructions for Use part 1 of 2�
2� To prepare for sampling of specimen, turn the flow switch counterclockwise towards the
sample container, and align it horizontally 6�
3� Instillation of fluids should be performed in accordance with Instructions for Use part 1 of 2
for aScope™ 5 Broncho�
4� Perform sampling by pressing the suction button on the aScope™ 5 Broncho� Ensure that
the endoscope is held upright and level while sampling� Do not fill the sample container
above the maximum of the volume indicator scale�
5� 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™ 5 Broncho� When suction
is complete, turn the flow switch counterclockwise towards the sample container, and
align it horizontally�
6� Remove the sample container by pressing the flip top and pulling the sample container
from the sampler bridge 7� Ensure that the endoscope is held level and that the flip top
is depressed during the removal of a sample container which holds fluid�
7� Close the sample container by pressing the sample container lid towards the sample
container interface and engage the lid until it closes� Once the click-lock is engaged, do
not re-open the lid 8�
4.3. After use
1� If deemed relevant, detach the sampler bridge from the aScope™ 5 Broncho by
disengaging the attachment lock and pulling the sampler bridge off the aScope™ 5
Broncho� Disengage suction by pulling the suction tube off the sampler bridge�
2� If deemed relevant, access the sample container by turning the sample container vial
clockwise 9� It is recommended to handle contaminated substances in accordance with
local guidelines�
3� Transportation and handling of a used sample container must be performed in
accordance with local guidelines for transportation and handling of hazardous material�

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Duration of use
•The BronchoSampler 60 is suitable for up to 60 minutes of use during a procedure�
NOTE: Always follow local guidelines for transportation/storage conditions of a filled sample container�
Disposal
The BronchoSampler 60 is a single-use device� BronchoSampler 60 is considered infected after
use and must be disposed of in accordance with local guidelines for the collection of infected
medical devices�
5. Technical product specifications
5.1. Standards applied
The BronchoSampler 60 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. Specifications for BronchoSampler 60
Suction connector1
Suction tube with female interface Ø 5�5 – 9�0 mm
Suction tube with male interface
Applicable when suction adapter is used Ø 6�0 – 8�0 mm
Sample container
Sample container volume 60 ml
Storage
Recommended storage temperature210 – 25 °C (50 – 77 °F)
Relative humidity 10 – 85 %
Atmospheric pressure 50 – 106 kPa
Operating environment
Temperature 10 – 40 °C (50 – 104 °F)
Relative humidity 30 – 85 %
Atmospheric pressure 80 – 106 kPa
Altitude ≤ 2000 m
Sterilisation
Method of sterilisation ETO
1� Please check for compatibility with suction tubing before use�
2� Storage under higher temperatures may impact shelf life�

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6. Troubleshooting
If problems occur with the system, please use this troubleshooting guide to identify the cause
and correct the error�
Problem Possible cause Recommended action
Absent or reduced
suction or sampling
capability�
The sample container is not
attached, or poor connection
of the sample container�
Connect or re-connect the
sample container to the
sampler bridge�
Sampler bridge may not be
connected properly to
the aScope™ 5 Broncho�
Re-connect the sampler bridge
to aScope™ 5 Broncho and push
in the attachment lock to secure
the connection�
The 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
the suction connector or
the suction adapter�
Ensure that the parts are
properly connected� If suction
is still absent or reduced
change to another vacuum
suction tubing�
The rubber seal may have come
off the connection interface�
Re-insert the rubber seal
manually� However, if it is
believed that the rubber seal
may be in contact with an
unclean surface, it may be
necessary to replace the
sampler bridge�
Unable to connect
sample container,
sampler bridge, and/
or endoscope�
The attachment lock may be
closed before attaching the
sampler bridge to an endoscope�
Pull out the attachment lock
before attaching sampler
bridge to endoscope�
The sample container lid may be
closed before insertion�
Replace the sample container
with the spare provided�
Do not attempt to open the
sample container lid once closed�
Tubing cannot
be attached to
Sampler bridge�
Incorrect configuration of tubing
(male to the male suction
connector)�
The suction adapter can be
used to allow male-to-male
connections�

492 6212 00 – V04 – 2023/03. TCC 11460
Ambu Australia Pty Ltd | Ambu New Zealand Pty Ltd
Unit 5, 2 Daydream Street, Warriewood, NSW 2102
Tel (AUS): 1300 233 118 | Tel (NZ): 0800 804 079
Email: [email protected] Web:
www.ambuaustralia.com.au
AA23 0179V01
Always read the Instructions for Use.
These products are only available for sale to
healthcare professionals.
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Ambu and other trademarks are trademarks of Ambu A/S�