Surgical Company Axess Vision Broncoflex M User Manual Download Page 6

 

3.  P

ACKAGING

 

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.  S

TORAGE 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.  D

ESCRIPTION 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 

Broncoflex 

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 

 

Summary of Contents for Axess Vision Broncoflex M

Page 1: ...1 www axessvision tsc com EN User manual Single use only Use by qualified medical personnel Revision February 2019 CE Marking first affixed 2011 0120...

Page 2: ...l 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 D...

Page 3: ...r 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...

Page 4: ...paration 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 me...

Page 5: ...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 ab...

Page 6: ...c 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 in...

Page 7: ...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...

Page 8: ...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 distrib...

Page 9: ...h 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 b...

Page 10: ...ective 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...

Page 11: ...TURER S CONTACT DETAILS SA AXESS VISION TECHNOLOGY Zone de la Liodi re 6 rue de la Flotti re 37300 JOUE LES TOURS France Tel 33 0 2 47 34 32 90 E mail info axessvision tsc com Axess Vision Technology...

Page 12: ...ll rights reserved Any reproduction partial or complete of the page by any process electronic photocopy printer magnetic tape disk CD ROM or other means is forbidden without written permission from AX...

Reviews: