Surgical Company Axess Vision Broncoflex Series User manual

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www.axessvision-tsc.com
EN
User manual
Single-use only
Use by qualified medical personnel
Revision February 2019
CE Marking first affixed: 2011
0120

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TABLE OF CONTENTS
1. Introduction .............................................................................................................................................. 4
Areas of application ................................................................................................................................... 4
User manual .............................................................................................................................................. 4
User training and qualifications .................................................................................................................. 4
Accessories ............................................................................................................................................... 5
Substances used ....................................................................................................................................... 5
2. Precautions in use ................................................................................................................................... 5
3. Packaging ................................................................................................................................................. 6
4. Storage precautions ................................................................................................................................ 6
5. Description of device ............................................................................................................................... 6
Technical characteristics ............................................................................................................................ 6
Articulation lever ........................................................................................................................................ 7
Clamping mechanism ................................................................................................................................. 7
Operating channel ...................................................................................................................................... 7
6. Instructions for use ................................................................................................................................. 7
Procedure .................................................................................................................................................. 7
7. Safety ........................................................................................................................................................ 8
Instructions if packaging is damaged ......................................................................................................... 8
Information about the technical properties/factors which could pose a risk if the device should be reused . 8
Disposal of the consumable ....................................................................................................................... 8
Contact with the patient .............................................................................................................................. 8
8. Warranty ................................................................................................................................................... 8
9. Malfunctions ............................................................................................................................................. 9
There is no image displayed, or the LEDs do not light up ........................................................................... 9
Channel blocked ........................................................................................................................................ 9
Poor suction ............................................................................................................................................... 9
10. Meaning of icons on Broncoflex label .................................................................................................... 9
11. Standards applied ...................................................................................................................................10
12. Manufacturer's contact details ...............................................................................................................11
13. Distributor's contact details ...................................................................................................................11

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Detailed view of the Broncoflex®
The applied part of the medical device is the whole of the flexible pipe containing the tube and the distal head
(BF type applied part: BF type electronic device complying with IEC 60601-1. Electrical discharge protection.) All
other parts of the system (display system and trolley) are present in the patient environment.
The Broncoflex may only be used with the following display systems, supplied by Axess Vision Technology.
IEC 60601-1: electro-medical devices. General requirements for basic safety and essential performance.
BOXi SCREENi
View of display systems
View of the Broncoflex®
Articulation lever
Up-Down
Clamp (opening/closing the
suction channel)
Input from operator
channel
Suction cone

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IT IS ESSENTIAL TO READ THIS DOCUMENT CAREFULLY.
1. INTRODUCTION
Areas of application
This video-bronchoscope is designed to provide an optical display of the pulmonary pathways on a monitor. The
pulmonary pathways include the organs, tissues and sub-systems which are the nasal pathways, the trachea
and the bronchial tree, beyond the primary bronchi. Instruments are inserted orally or nasally, when indications
are seen consistent with the requirements for this procedure in adult patients, using the Broncoflex M, and
patients weighing more than 10kg with the Broncoflex S. This device cannot be used for diagnostic purposes.
The Broncoflex may only be used for the purpose described here.
User manual
This user manual contains essential information for using this product safely and correctly. Read this manual and
those for all the instruments used carefully, and use them in accordance with these instructions. Keep the usage
instructions in a safe place, easily accessible. For any questions or comments you may have concerning their
use, contact Axess Vision Technology at once.
This manual describes the procedures for inspection and preparation recommended prior to using the
equipment. It does not describe how any particular procedure is performed. Nor is it intended to teach a novice
how to use the equipment correctly, or about any medical issues relating to its use. Only a person trained in
bronchial endoscopy techniques, and familiar with the risks involved, is authorised to use the BRONCOFLEX.
The chief known risks and/or potential injuries associated with flexible endoscopy procedures are as follows:
perforation, infection and haemorrhage.
It is vital to comply strictly with all the instructions given in this user manual. Misunderstanding of these
instructions could lead to:
 serious or even fatal injury to the patient
 serious injury for the user
 serious injury for third parties
 damage to the equipment.
User training and qualifications
Before delivering the system, the qualified Axess Vision Technology distributor provides training in its use.
If there are official regulations regarding user qualifications in endoscopy practice and treatment, set down by the
medical authorities or other official bodies, such as the academic endoscopy associations, these must be
respected.
Otherwise, this instrument may be used only by a doctor approved by the hospital’s accident prevention
manager, or the manager of the department concerned (internal medicine department, etc.).

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Accessories
Follow best practice in endoscopy and professional standards for use of accessories. If a specific or very
specialised accessory is available from another manufacturer, please contact Axess Vision Technology to test its
compatibility before using it with the endoscope.
The effective length of an endoscope accessory must exceed that of the effective length of the endoscope by at
least around 30cm.
Substances used
The operating channel of the Broncoflex is compatible with the substances normally used during a
bronchoscopic examination (physiological water, mucous membrane lubricants, standard light anaesthetics used
for this type of procedure, etc.).
2. PRECAUTIONS IN USE
 Check the packaging is not damaged before use. Any device whose packaging is damaged must not be
used, and must never be resterilised.
 Check each Broncoflex before use, looking for any damage. If the product is damaged, do not use the
device.
 The product must be handled and used with extreme care by qualified personnel.
 Check the clamp on the handle and the Up/Down articulation lever are operating correctly.
 Check the operating channel plug is in place.
 Clean the lens with an optical wipe if necessary.
 Comply strictly with the rules about asepsis when handling the product.
 If there are any problems inserting the product into the bronchi or into a probe, do not force it, and try to
ascertain the cause before continuing.
 Carefully select the correct size of the intubation probe for each patient.
 The compatibility of the Broncoflex with all non-powered accessories must be checked before each use.
 Do not use the device while administering a highly-flammable anaesthetic gas to the patient.
 Do not use the device during defibrillation.
 It is strictly forbidden to use:
o powered endotherapy accessories with the bronchoscope,
o active endoscopic accessories (such as laser probes or electro-surgical equipment).
 Handle cutting or piercing tools with care, in order not to damage the flexible tube of the endoscope.
 Provide a similar, back-up system so that the procedure can continue in the event of a malfunction.
 The Broncoflex is discarded after use into the container for single-use contaminated items.
 Do not exceed a suction pressure of 400 mmHg (533 mbar)

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3. PACKAGING
The consumable is sterile and supplied ready-to-use in its sealed wrapper. Consumables are supplied in boxes
of 5 or 10. Each ETO-sterilised consumable is in a sterile pouch inside the box. See the label on the top of each
of the wrappers.
This product must never be resterilised.
4. STORAGE PRECAUTIONS
The devices must be kept in their original, sealed wrappers, in a clean, dry place, out of sunlight. Storage
conditions for optimal preservation of the products are at normal temperature and pressure levels, around 20°C
and 1013 bar.
5. DESCRIPTION OF DEVICE
The Broncoflex is a single-use bronchoscopic system that is part of an overall system. The full system consists
of a video-bronchoscope, the BOXi or SCREENi electronic unit and/or a display monitor.
The Broncoflex is equipped with:
 A lever to control an Up/Down articulation,
 A control button to start suction when connected to the vacuum system,
 An operating channel input with end-piece for using tools.
The Broncoflex device is made of materials compliant with bio-compatibility requirements for medical devices.
The distal head has a display and illumination system enabling it to move along the patient's respiratory system.
Technical characteristics
Type Broncoflex
S
Broncoflex
M
Direction of field of vision 0° 0°
Angle of field 120° 120°
Depth of field 3 - 80 mm 3 - 80 mm
Angle of articulation X (up/down) 160°/160° 160°/130°
Radius of articulation 4.5 mm 9 mm
External diameter of insertion tube 3.7 mm 5.5 mm
External diameter of distal end 3.9 mm 5.5 mm
Internal diameter of operating channel 1.4 mm 2.1 mm
Effective length 600 mm 600 mm
Lighting system 2 LEDs 2 LEDs
Image resolution 250x250 250x250

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Articulation lever
The handle consists of an articulation lever controlling the Up or Down direction The maximum angle of
articulation for upward movement is around 160°, and 130° downward (160° on the Broncoflex S).
Clamping mechanism
Exerting pressure on the suction channel control lever activates suction on the suction channel.
Operating channel
The system has an operating channel controlled from the handle to the distal end which is compatible with
existing accessories.
The operating channel allows the practitioner to insert standard procedural tools used for specified endoscopic
applications. This channel is designed to take the usual specimen collection tweezers. The operating channel is
coupled to the suction channel with a “Y” junction.
A plug can be used on the operating channel to place a hermetic seal on it, so that the suction channel is
isolated and works effectively. It is supplied with the consumable item.
6. INSTRUCTIONS FOR USE
 This is a single-use device. There is a risk of cross-infection if the Broncoflex is re-used.
 Do not use alcohol on the lenses.
 Before the bronchoscope is used each time, check the parts that will be inserted into the
patient to make sure there are no rough areas, sharp or protruding edges that could cause
injury.
 The compatibility of the endoscopy appliances with all non-powered accessories must be
checked before each use.
Axess Vision Technology will not accept any liability in the event of improper use of its products,
whether for injury to a patient or damage to the device.
Procedure
1. Remove the tracking label from the endoscope packaging and keep it.
2. Remove the endoscope from its pouch.
3. Connect the endoscope to the BOXi or SCREENi then power it up.
4. Remove the white (disposable) protective tube before the examination.
5. Follow the instructions from the user manual for the BOXi or the SCREENi.
6. Check that the illumination LEDs and camera are working properly, by focusing on an object (for instance
the palm of the hand).
7. If the image is not clear, clean the distal head with a suitable optical wipe (alcohol-free).
8. Check the movement of the articulation up and down, according to the specified angles.
9. Test the watertightness of the channel by connecting a syringe filled with a sterile liquid physiological
serum to the threaded endpiece. Check there are no leaks.

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10. Connect a tube from the endoscope endpiece to the suction system (not supplied). Then check that the
piston controlling the suction is working properly.
11. Check the tools provided for the procedure are compatible with the Broncoflex and working satisfactorily.
12. The system is now ready to use.
13. Proceed with the examination.
14. After use, the Broncoflex must be discarded in the container for single-use contaminated items.
If the Broncoflex has to be used several times on the same patient, make sure it is placed in sterile storage
conditions. The practitioner is responsible for determining whether contamination might take place in the period
between 2 uses on the same person.
The temperature of the distal endpiece of the endoscope may reach 41.9°C with the heat of the LEDs. Prolonged
contact with the mucous membrane may cause injury (tissue damage or coagulation). It is advisable to avoid
prolonged contact between the endpiece of the device and the mucous membrane.
7. SAFETY
Instructions if packaging is damaged
When the box is opened, if the packaging providing the sterile barrier for the consumable is pierced or open, the
consumable must not be used, as it may be contaminated by various bacterial strains.
It must be returned to the distributor, and must not be resterilised in any circumstances.
Information about the technical properties/factors which could pose a risk if
the device should be reused
The Broncoflex must be discarded after use to avoid any cross-contamination.
Disposal of the consumable
The Broncoflex must be discarded in bins and containers intended for contaminated items. Soiled material must
be collected in special, covered containers, then incinerated.
Contact with the patient
The endoscope alone is considered to be the applied part, and only this part of the equipment should be in
contact with the patient.
8. WARRANTY
A Broncoflex has a three-year shelf life from the date of manufacture. To avoid any risk of contamination, no
contaminated medical device may be returned. If a product is found to have a fault, please refer the matter to
your normal contact, with as much detail as possible, so that a form can be completed. It may be helpful to
provide photographs of the fault, if it is visible.
If a fault is found, the distributor will replace the product or products.

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9. MALFUNCTIONS
There is no image displayed, or the LEDs do not light up
The device is no doubt not properly connected to the BOXi/SCREENi.
Make sure the connector has properly clicked into the BOXi/SCREENi and the BOXi/SCREENi turns on. Please
refer to the user manual for the BOXi/SCREENi.
Channel blocked
Clean the operating channel using a cleaning brush, or rinse it out by injecting a sterile physiological solution
with a syringe. If it is impossible to clear the operating channel, prepare a new endoscope.
Poor suction
The valve intended to block the biopsy Y is damaged or badly fitted. Change or re-fix the valve.
Excessive suction pressure may reduce the suction performance of the endoscope. Broncoflex has been
validated for a maximum suction pressure of 400 mmHg (533 mbar) The use of a pressure regulator set at a
pressure of below 400 mmHg (533 mbar) is recommended.
10. MEANING OF ICONS ON BRONCOFLEX LABEL

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Pictograms Meaning
For single-use only, do not re-use
Do not resterilise
Sterilised with ethylene oxide
Product manufacturer
Do not use if packaging is open
Number of items in the package
Check the user manual for use of this product
Serial number
Product expiry date
BF type applied part: BF type electronic device complying with IEC 60601-1.
Electrical discharge protection.
Batch number
Protect from sunlight and UV
Conformity marking pursuant to European Medical Device Directive MDD
90/42/EEC together with the identification number of the notified body: SGS
Protect from moisture
Fragile
Storage temperature
A suction pressure of 400 mmHg must not be exceeded
11. STANDARDS APPLIED
The Broncoflex operates in accordance with the following regulatory texts:
 European directive 93/42/CEE relating to medical devices
 CEI 60601-1: Electro-medical appliances – Part 1: General requirements for safety
 CEI 60601-2-18: Electro-medical appliances – Part 2-18: Special requirements for safety of endoscopy
appliances:
 CEI 60601-1-2: Electro-medical appliances – Part 1-2 General safety requirements – Collateral standard:
Electromagnetic compatibility - Requirements and tests