Summary of Contents for Surgical Company Axess Vision Broncoflex Series
- Page 1 User manual Single-use only Use by qualified medical personnel 0120 Revision February 2019 www.axessvision-tsc.com CE Marking first affixed: 2011...
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Page 2: Table Of Contents
TABLE OF CONTENTS Introduction .............................. 4 Areas of application ........................... 4 User manual .............................. 4 User training and qualifications ........................4 Accessories ............................... 5 Substances used ............................5 Precautions in use ........................... 5 Packaging ..............................6 Storage precautions ..........................6 Description of device .......................... - Page 3 Clamp (opening/closing the suction channel) Input from operator channel Suction cone Articulation lever Up-Down 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.
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Page 4: Introduction
T IS ESSENTIAL TO READ THIS DOCUMENT CAREFULLY 1. I NTRODUCTION 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. -
Page 5: Accessories
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. -
Page 6: Packaging
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. -
Page 7: Articulation Lever
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. -
Page 8: Safety
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. -
Page 9: Malfunctions
9. M ALFUNCTIONS 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. -
Page 10: Standards Applied
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. -
Page 11: Manufacturer's Contact Details
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: info@axessvision-tsc.com Axess Vision Technology certifies the conformity of its equipment, both design and manufacture, with reference... - Page 12 Copyright @2016 SA AXESS VISION TECHNOLOGY: All 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 AXESS VISION TECHNOLOGY. info@axessvision-tsc.com...
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