EN

User manual
Single-use only
To be used by qualified medical personnel

Broncoflex® Vortex 10030001

®
Broncoflex Agile 20030001

1639

10030512-F

10030512-F 1
 EN
Table of Contents

1. Important information - read before use ........................................................................................................................... 3

1.1 Foreword ............................................................................................................................................................................ 3

1.2 Intended use ...................................................................................................................................................................... 3

1.3 Indications for use.............................................................................................................................................................. 3

1.4 Contraindications ............................................................................................................................................................... 4

1.5 User qualification ............................................................................................................................................................... 4

1.6 Warnings and cautions for use ...................................................................................................................... 4

2. Description of the Broncoflex ............................................................................................................................................. 5

2.1 Product description............................................................................................................................................................ 5

2.2 Checking package contents ................................................................................................................................................ 6

2.3 Broncoflex details .............................................................................................................................................................. 6

3. Instructions for using the Broncoflex .................................................................................................................................. 7

3.1 Precautions prior to use ..................................................................................................................................................... 7

3.2 Using the Broncoflex for an examination .......................................................................................................................... 7

3.3 Consumable disposal ......................................................................................................................................................... 8

4. Warranty ............................................................................................................................................................................ 8

5. Troubleshooting ................................................................................................................................................................. 8

6. Transport, storage and use conditions ............................................................................................................................... 8

7. Broncoflex labels and symbols ........................................................................................................................................... 8

8. Technical characteristics................................................................................................................................................... 10

8.1 Essential performance ..................................................................................................................................................... 10

8.2 Information concerning the electrical safety rating and electromagnetic compatibility ................................................ 10

9. Applicable standards ........................................................................................................................................................ 10

10. Manufacturer’s contact details......................................................................................................................................... 11

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1. IMPORTANT INFORMATION - READ BEFORE USE
“WARNING” indicates a particularly hazardous situation. Failure to observe the instruction may damage the
instrument, cause injury, or even death.

“CAUTION” indicates that use or improper use of the instrument may cause a problem, such as product
malfunction, failure or damage.

1.1 Foreword
This user manual contains essential information for the optimum and safe use of the Broncoflex®. The information in this user
manual is subject to change at any time, without notice. Make sure that you are using the latest version by logging onto Axess
Vision website https://endovision.tsc-group.com/ or contacting the distributor.
This user manual does not contain any explanations of information concerning endoscopic techniques per se.
Carefully read this manual, along with the manuals for all the instruments used, and use them as instructed. Keep all user manuals
in a safe and readily accessible place. Should you have any questions or comments concerning this manual, contact us for more
information.
This manual describes the recommended inspection and preparation procedures to be followed before using the instrument,
along with the precautions to take for product disposal after use.
Carefully follow all the instructions given in this user manual. Poor understanding of these instructions could lead to:
 severe injuries to the patient,
 severe injuries to the user,
 severe injuries to a third party,
 equipment damage.

1.2 Intended use

This video-bronchoscope is intended to provide an optical display of the pulmonary tract using a monitor (Screeni®) and to be used
with endotherapy accessories and instruments.
The pulmonary tract include the organs, tissues and subsystems represented by the nasal passages, trachea and bronchial tree
beyond the primary bronchi. The video-bronchoscope is inserted via the oral or nasal route.
The Broncoflex should not be used for any purpose other than that described herein.

1.3 Indications for use

This video-bronchoscope is designed for use exclusively in a hospital environment.

Endotherapy accessories and instruments

The effective length of an endoscopic instrument should be at least 30 cm greater than the effective length of the endoscope.

Minimum compatible dual

Minimum compatible Maximum size of
Model lumen endo-bronchial tube
endotracheal tube size endotherapy instruments
size

Broncoflex Agile ≥ 5.0 mm ≥ 35 Fr. ≤ 1.2 mm

Broncoflex Vortex ≥ 6.0 mm ≥ 41 Fr. ≤ 2.6 mm

Patient Population
The Broncoflex can only be used on adult patients.

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 1.4 Contraindications
The images generated by this device should not be used for diagnostic purposes. The Broncoflex is suitable for qualitative
visualization but not for structural sizing. Indeed, quantitative sizing may lead to inaccurate results because the geometric
distortion of the device has not been evaluated.
Physicians must interpret and support any findings in other ways, based on the patient's clinical data.

1.5 User qualification

The Broncoflex should only be used by trained medical personnel who are authorised to perform bronchial endoscopy procedures
under the responsibility of the physician in charge of the patient's examination.
Where there are official standards and/or regulations relating to user qualification for performing endoscopy, and endoscopic
treatment defined by the medical administration or by other official institutions, such as the academic endoscopy society, these
must be respected.
Otherwise, this instrument must only be used by a doctor approved by the head of department responsible for accident prevention
in the hospital or by the person in charge of the corresponding department (pulmonology department, etc.). The physician must
be able to perform the video endoscopy and the planned endoscopic procedure, safely, in accordance with the guidelines set by
the academic endoscopy society and considering the risks of complications related to endoscopy and the endoscopic procedure.
Staff should be aware of potential risks and injuries associated with endoscopic procedures that are primarily: perforation,
bleeding, and infection.

1.6 Warnings and cautions for use

Observe all the warnings and precautions described in this manual. Otherwise, Axess Vision cannot be held liable in case of injury
to the patient or user or damage to the device.

Check that the packaging is intact before use. Devices for which the packaging has been damaged must not be
used and must not, under any circumstances, be re-sterilised.

Always check the expiry date indicated on the Broncoflex label before use.

Inspect each Broncoflex before use to detect any deterioration. If the product is damaged, does not function
properly, or has been dropped, do not use it.

In the event of difficulties inserting the applied part of the Broncoflex into the bronchi or a tube, do not apply
force and attempt to determine the cause before continuing.
Powered and/or active endotherapy instruments (e.g. laser probe or other electrosurgical equipment) must not
be used with the Broncoflex.
Before each use, the compatibility of the Broncoflex with all non-powered endotherapy accessories and
instruments should be checked.
Handle cutting or perforating endotherapy instruments with care so as not to damage the flexible tube of the
Broncoflex.
The device is single-use. Do not reuse the Broncoflex, as it may contaminate or cross-contaminate, leading to
infection of the patient.

Before using the Broncoflex, check the parts to be inserted into a patient to ensure that there are no rough
surfaces, sharp edges or unwanted projections that could cause damage.

Do not use the device while administering a highly flammable anaesthetic gas to the patient as this may cause
injury to the patient.

Do not use the device during defibrillation as this may cause injury to the user.

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 Risk of injury to the patient or damage to the Broncoflex when inserting or removing an accessory into or from
the working channel while the deflection zone is not straight and the deflection lever is not released.

No Broncoflex modifications or repairs are allowed.

Using the Broncoflex near medical devices that generate high frequencies can disrupt the image. In order to
continue the examination properly, any interfering devices should be removed or disabled.

Should a malfunction occur while using the Broncoflex, immediately stop the examination in progress and
carefully remove the Broncoflex from the patient after having released the deflection lever.

The light-emitting portion on the distal end of the endoscope may radiate heat. Prolonged contact with the
mucous membrane may cause injury (tissue damage or coagulation). Prolonged contact between the tip of the
device and the mucous membrane should be avoided.

The patient’s vital signs must be monitored throughout the examination.

The product must be handled and used with extreme care by qualified personnel.

Provide a similar backup system so that the procedure can continue in the event of malfunction.

Do not exceed a suction pressure of -638 mmHg (-850 mbar).

Do not use alcohol on the lens. If necessary, clean the lens with isotonic saline solution and a sterile non-woven
compress.

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

For the use of endotherapy accessories or instruments, follow good endoscopy practice. Please contact Axess
Vision or your distributor to verify the compatibility of specific or highly specialised endotherapy accessories or
instruments prior to use with the Broncoflex.

2. DESCRIPTION OF THE BRONCOFLEX

2.1 Product description
The Broncoflex is a single-use video-bronchoscope which is part of a system made up of the endoscope (Broncoflex) and its
reusable display monitor (Screeni). For further information concerning the Screeni display monitor, please see the corresponding
user manual.

System components

Bronchoscopes
Working channel
External diameter of
Item code Description inner diameter Colour code
insertion tube (mm)
(mm)
Orange
Broncoflex Min: 5.4
10030001 Min: 2.8
Vortex Max: 5.6

Grey
Broncoflex Min: 3.6
20030001 Min: 1.4
Agile Max: 3.9

Display monitor
Item code Description Illustration

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 30030001 Screeni

2.2 Checking package contents

The Broncoflex is supplied sterile and ready to be used in a sterile bag (sterilisation method: ethylene oxide ETO).
Broncoflex devices are packaged in boxes of 5.
When opening the box, if you notice that the packaging providing the consumable’s sterile barrier has been pierced or opened,
do not use the Broncoflex. It should be returned to the distributor and must not, under any circumstances, be re-sterilised.

2.3 Broncoflex details 8

5 7
1 6 (9)
2
10 11 12 13

14
3
4

Number Component Position Material

Connects the endoscope to its Screeni display
1 Connector Grey ABS and black TPE
system.
Transmits the video signal to the Screeni display
2 Video cable PVC
monitor.
3 Suction cone Connects the endoscope to a suction system. POM
4 Deflection lever Controls distal end high/low deflection. ABS
5 Suction button Activates suction when pressed. ABS
Used to hold the system, suitable for left- and
6 Handle ABS-PC
right-handed users.
Used to hermetically seal the working channel
7 Biopsy valve infeed and ensure it remains airtight during Silicone
instrument insertion through the valve.
Used to screw on a device (syringe type) to the
8 LUER LOCK connector POM
working channel.
9 Working channel Used to inject liquid or to pass an instrument. PU
Provides the junction between the handle and
10 Tube guard TPE
the insertion tube.
11 Insertion tube Flexible part inserted into the airways. TPE
Articulates in one plane: up and down, when the
12 Articulated section TPE
deflection lever is pressed.
Contains the LEDS, camera and the outfeed of
13 Distal tip HPP
the working channel.
11-12-13 Applied part Insertion tube, articulated section and distal end. See corresponding number
14 Blister pack Protects the endoscope during transport. APET
Sterile barrier (bag). PET& PET & Tyvek
- Packaging items
Box package. Cardboard

Abbreviations: ABS (acrylonitrile butadiene styrene), TPE (thermoplastic elastomer), PVC (polyvinyl chloride), POM
(polyoxymethylene), PU (polyurethane), PC (polycarbonate), HPP (high performance polymer), APET (amorphous polyethylene
terephthalate), PET (polyethylene terephthalate), HDPE (high density polyethylene).
The materials making up the Broncoflex comply with biocompatibility requirements for medical devices.

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3. INSTRUCTIONS FOR USING THE BRONCOFLEX
3.1 Precautions prior to use
Check that the packaging is intact before use. Devices for which the packaging has been damaged must not be
used and must not, under any circumstances, be re-sterilised.

Always check the expiry date indicated on the Broncoflex label before use.

Inspect each Broncoflex before use to detect any deterioration. If the product is damaged, does not function
properly, or has been dropped, do not use it.
Before each use, ensure that the Broncoflex is compatible with all the non-powered endotherapy accessories
and instruments used.
Before use and upon receipt of the system, the elements received should be visually inspected in order to detect any potential
damage caused during the transport phase. Ensure that all components are present, using the system description in this user
manual. If any components are missing or damaged, do not use the system and contact your local distributor.
As long as the sterile barrier (bag) has not been opened, the Bronchoscope remains sterile in its packaging.
Once the bag is open, gently remove the endoscope from its blister pack. It is now ready for use.
Only the distal end and endoscope insertion tube are considered as applied parts and only these parts of the equipment should
come into contact with the patient.

3.2 Using the Broncoflex for an examination

In the event of difficulties inserting the applied part of the Broncoflex into the bronchi or a tube, do not apply
force and attempt to determine the cause before continuing.
Powered and/or active endotherapy instruments (e.g. laser probe or other electrosurgical equipment) must not
be used with the Broncoflex.

Do not use the device during defibrillation as there is a risk of user injury.

Risk of injury to the patient or damage to the Broncoflex when inserting or removing an accessory into or from
the working channel while the deflection zone is not straight and the deflection lever is not released.

The product must be handled and used with extreme care by qualified personnel.

Do not exceed a suction pressure of -638 mmHg (-850 mbar).

1. Connect the endoscope connector to the Screeni port identified by the symbol , then power on the Screeni
(follow the instructions in the Screeni user manual).

2. Check that the illumination LEDs and camera are working correctly by pointing at an object (for example the palm of the
hand).

3. Make sure that the deflection functions in the up and down position at the specified angles.

4. Test the working channel seal by connecting a syringe filled with sterile saline-type liquid to the LUER LOCK screw tip.
Check for leaks.

5. Connect a hose between the suction cone of the endoscope and the suction system (not supplied). Use a regulator to
adjust the suction pressure to a value of no more than -638 mmHg (-850 mbar). Next, check the operation of the piston
controlling suction.

6. Ensure that the endotherapy instruments provided for the procedure are compatible with the Broncoflex and are
satisfactory.

7. The system is now ready for use. Proceed with the examination.

8. At the end of the examination, remove the Broncoflex gently after releasing the deflection lever.

9. Once removed, ensure that there are no damaged or missing endoscope parts.

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 To end, switch off the Screeni display monitor, then disconnect and dispose of the Broncoflex.

3.3 Consumable disposal

After use, the Broncoflex is considered to be contaminated. To avoid any contamination, it must be discarded in accordance with
local directives concerning the disposal of contaminated medical devices comprising electronic components.

4. WARRANTY
The Broncoflex is not covered by a warranty. The Broncoflex shelf-life is specified on the product label. If you observe a product
defect, please report the information to the distributor, providing as much detail as possible. If necessary, take photos of the
defect if it is visible.

5. TROUBLESHOOTING
Inspection indications and actions are proposed below to resolve most problems encountered.
If the following instructions are insufficient to correct the problem encountered, return the Broncoflex to the local Axess Vision-
accredited distributor for analysis. To avoid any risk of contamination, it is strictly prohibited to return a contaminated medical
device.

Problem Cause(s) Actions

No image Ensure that the connector is pushed firmly into the port on
The connector is incorrectly
and/or the Screeni and that the Screeni is switched on.
attached to the Screeni
LEDs do not illuminate See the Screeni user manual.
Vision impaired by secretions Clean the lens with isotonic saline solution and a sterile non-
Poor quality image
on the camera. woven compress.
The biopsy valve is damaged,
poorly fitted or incorrectly Re-fit/close the valve, or replace it.
Defective suction closed.
Excessive or insufficient suction Adjust the suction pressure to no more than -638 mmHg (-
pressure 850 mbar).
Outside of the patient, clean the channel with a cleaning
brush, or rinse it by injecting a sterile isotonic solution with
The working channel is
Channel obstructed a syringe.
obstructed by secretions
If the working channel cannot be cleared, prepare a new
endoscope.

6. TRANSPORT, STORAGE AND USE CONDITIONS

Broncoflex devices must be stored in their original unopened packaging, in a clean, dry and dark place. The storage conditions to
ensure optimum product shelf life are normal temperature and pressure conditions, i.e. 20 °C and 1.013 bar.

Parameters Minimum Maximum

Temperature -10 °C (14 °F) +60 °C (140 °F)
Transport and storage
Relative air humidity (no condensation) 10% 90%
conditions
Atmospheric pressure 80kPa 109kPa
Temperature + 10 °C (50 °F) + 40 °C (104 °F)
Conditions of use Relative air humidity (no condensation) 30% 85%
Altitude and atmospheric pressure ≤ 2000m – 80kPa ~ 109kPa

7. BRONCOFLEX LABELS AND SYMBOLS

The meanings of the various symbols and labels are described in the table below:
Symbol Meaning

For single use only, do not re-use.

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 Do not re-sterilise.

Ethylene oxide-sterilised.

Product manufacturer.

Do not use if package is damaged.

Number of elements in the package.

See the user manual before use.

Indicates that the instructions for use contain important cautionary information, such as warnings
and precautions, that cannot, for various reasons, be displayed on the medical device itself.

See the user manual for instructions on using this product.

GTIN (Global Trade Item Number).

Product expiry date (Year-Month-Day).

Part applied to the BF: BF type electronic device, compliant with standard “IEC 60601-1.
Protection against electrical discharges”.
Batch number.

Product catalogue number.

Keep out of sunlight and away from UV radiation.

Conformity marking as per the European medical devices directive (MDD) 93/42/EEC,
accompanied by the identification number of the notified body SGS.

Do not expose the box to rain.

Fragile contents.

Store in an environment with a relative humidity of between 10 and 90%.

Store in an environment with a temperature of between -10 and +60 °C.

Store in an environment with an atmospheric pressure of between 80 and 109 kPa.

Patented device.

Minimum working channel inner diameter and maximum applied part outer diameter.

Effective length of the inserted part.

Camera field of vision.

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 Deflection angle of the distal end.

Device to be used on prescription only.

8. TECHNICAL CHARACTERISTICS
Type Broncoflex Vortex Broncoflex Agile

Product reference 10030001 20030001

Field of vision direction 0°

Field of vision 87.5°

Field depth 5 ~ 50 mm

Lighting system 2 LEDs

Image resolution 400x400

High/low deflection angle 200° / 200° 220° / 220°

External diameter of insertion tube 5.4 mm 3.6 mm

Distal end outer diameter 5.6 mm 3.9 mm

Working channel inner diameter 2.8 mm 1.4 mm

Working length 605 mm

Sterilisation Ethylene oxide ETO

Device class IIa

8.1 Essential performance

The essential performance of the Broncoflex single-use bronchoscope is the viewing of the upper airways and of the bronchial
tree. It involves other procedures such as performing examinations requiring suction of secretions or the use of endotherapy
accessories or instruments designed for use in combination with a bronchoscope and compatible with the Broncoflex.

8.2 Information concerning the electrical safety rating and electromagnetic

compatibility
See the Screeni user manual.

9. APPLICABLE STANDARDS
Broncoflex operation complies with the following regulatory texts:
 Directive 93/42/EC: Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
 IEC 60601-1 edition 3.1: Medical electrical equipment - Part 1: General requirements for basic safety and essential
performance
 IEC 60601-1-2 edition 4: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential
performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
 IEC 60601-2-18: Medical electrical equipment - Part 2-18: Particular requirements for the basic safety of endoscopic
equipment
 ISO 8600-1: Medical endoscopes and endotherapy devices - Part 1: General requirements
 ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and tests within a risk management process
 ISO 80369-7: Small connectors for liquids and gasses used in the health sector - Part 7: 6% connectors (Luer) for
intravascular or hypodermic applications
Axess Vision certifies the compliance of its equipment, both in terms of design and of manufacturing to normative standards.

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10. MANUFACTURER’S CONTACT DETAILS
Axess Vision Technology
Zone de la Liodière
6 rue de la Flottière
37300 Joué-lès-Tours – France
https://endovision.tsc-group.com/

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AXESS VISION TECHNOLOGY

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