Surgical Company Axess Vision Broncoflex M User Manual Download Page 11

11 

 

  ISO  10993-1:  Biological  evaluation  of  medical  devices  -  Part  1:  Evaluation  and  tests  within  a  risk 

management process 

12. M

ANUFACTURER

'

S CONTACT DETAILS

 

SA AXESS VISION TECHNOLOGY 

Zone de la Liodière, 6 rue de la Flottière 37300 JOUE LES TOURS, France 

Tel: +33 (0)2 47 34 32 90   

E-mail: [email protected] 

 

Axess Vision Technology certifies the conformity of its equipment, both design and manufacture, with reference 
standards. 

 

13. D

ISTRIBUTOR

'

S CONTACT DETAILS

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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: