Surgical Company Axess Vision Broncoflex M User Manual Download Page 8

 

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.  S

AFETY

 

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.  W

ARRANTY

 

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. 

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...

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