User manual for the Broncoflex
Contents
1. AXESS VIS ON TECHN OL OG Y User manual for the Broncoflex For single use only Use by qualified medical staff Axess Vision Technology 3 rue Robespierre CE marking first affixed in 2011 37700 Saint Pierre des Corps User manual first revised in November 2014 FRANCE User manual for the Broncoflex Clamp opening closing of the suction channel Entry of the working channel Suction cone Up down tip deflection lever Overview of the Broncoflex User manual for the Broncoflex Contents 1 aie go 2 ol ilo a sirere mre tro ner er tre rer eter rrr ere rrrnt rater err rent erences snr rrrrcrer ret Tern neteryrrttrr errr rer errr rrr rrr ern err arr nr erry rete 2 PY SC AUIONNS or WS Cascais rica anre E E E E E E 3 PC MING ra T EE E E E E E aunts 4 SEO ACS Precautions cou erraccnasoancicrinereseserescusscnaeacarsncecgemeneeseancscusauucesmaaenesaue TOEA ousaseasveneneenuunnasensaneenaceusean 5 DOV ICS SSC iO OIA a aaste ee ca ceca te E O A vauen ca eusea ce ca eiat ei erdiaae asi eueeseciciee eaeiet ceieiaat Ge Instructions FON SC atacaiccceccieccs steed ceca nE E EEEE E EE EAEE TNE EO TEE AE E 7 EE LS A EAS NAE A S E VE O IE A E A E E S E A O E E A A A errr 8 N UY ea A T A EE T E N E E taaceanbucsss 9 M ACEO eee E E E EEE S 10 What the icons on the Broncoflex label Mean sssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssss 11 SG ICA SOO Seige passes erecta2. o 2 ra SF Ly A AN T ee d ee Gs ALANS The consumable is sterile and delivered ready to use in sealed packaging The consumables are delivered in a cardboard pack of 5 Inside this pack each EO sterilised consumable is placed in a single sterile bag Make sure you read the label on the top of each individual packaging L ee CAUTIONS J L OILS gt PI lt The devices must be kept in their unopened original packaging in a dry clean place away from sunlight The storage conditions for maintaining an optimum service life of the products are the normal temperature and pressure conditions i e 20 C and 1 013 bar posable bronchoscopic system that is part of an overall system This system comprises a video bronchoscope an electronic processor called a Box and a display screen tablet or monitor The Broncoflex s multifunctional handpiece comprises the following e alever for Up Down tip deflection e acontrol button to activate suction when it is connected to the vacuum network e aworking channel entry with Luer tip for using tools with a 1 8 mm diameter The materials making up this handpiece are as follows Pebax Pebd ULTEM ABS PEEK and Polyimide The distal end is fitted with a visualisation and lighting system enabling progress through the patient s respiratory system Technical characteristics 160 130 Minimum size of the endotracheal probe internal diameter User
3. manual for the Broncoflex Tip deflection lever There is a tip deflection lever on the handpiece to point Up or Down The maximum tip deflection angle Up is around 160 and Down 130 Clamping mechanism Suction with the suction channel is activated by using the control lever Working channel The system comprises a working channel controlled from the control handpiece to the distal tip which is compatible with existing accessories The working channel enables practitioners to insert the standard tools used in defined endoscopic applications for it has been designed to accommodate the usual sampling forceps The working channel is connected to the suction channel via a Y piece union A cap for the working channel can be used to seal it thereby isolating the suction channel and ensuring its efficacy during use This is supplied with the consumable 6 Instructions for use e The device is for single use only Do not reuse the Broncoflex consumable for there could be a risk of cross infection Do not use alcohol on the lenses Prior to using the bronchoscope each time check the parts intended to be introduced into a patient to ensure there is no unintentional rough surface sharp or protruding edge that could cause injury Prior to use check that the endoscopy devices are compatible with all accessories without electricity supply Axess Vision Technology shall not be held liable if a patient is injured or the devi
4. Ds heat up Prolonged contact with the mucous membrane can damage it Putting the device tip in contact with the mucous membrane for long periods is not advised a fom hv 3 f A edt ab Usp W J Instructions in the event of damaged packaging A o ri o cr When the cardboard pack is opened if the packaging ensuring the consumable s sterile barrier is pierced or open the consumable must not be used as it could have become contaminated by different strains of bacteria It must be returned to Axess Vision Technology Information concerning the technical factors characteristics which might pose a risk if the device has to be reused The consumable must be thrown away after use to avoid any cross contamination hospital acquired infections prion diseases etc Disposing of the consumable The consumable must be thrown away in designated bins and containers for contaminated objects The used equipment must be put into special containers fitted with a lid and then incinerated User manual for the Broncoflex Contact with the patient Only the endoscope is considered to be the applied part and only this part of the equipment must come into contact with the patient 8 Warranty The Broncoflex is delivered with a one year warranty from the manufacturing date which is also the product s validity date To avoid any risk of contamination contaminated medical devices must not be returned under any circumstances Should a
5. ce is damaged through incorrect use of its products Procedure Connect the endoscope to the Box then turn it on Remove the white protective tube disposable before beginning the examination Follow the instructions in the Box s user manual Check that the LEDs and camera work properly by directing them at an object the palm of your hand for example If the image is blurred clean the distal end with an appropriate optical cloth no alcohol Test that the tip deflection works in the Up and Down position according to the angles specified Test the channel sealing by connecting a syringe filled with sterile liquid e g saline solution to the Luer tip Check that there are no leaks e Connect a tube from the endoscope tip to the suction system not supplied Then check that the piston controlling the suction works properly e Check that the tools intended for use during the examination are compatible with the Broncoflex and are in satisfactory condition The system is then ready to use e Carry out the examination e After use the Broncoflex must be thrown away in the designated container for contaminated disposable devices If the Broncoflex needs to be used several times on the same patient it must be placed in sterile storage conditions The practitioner is responsible for determining whether or not contamination has occurred in the interval between two uses The temperature of the endoscope distal tip can rise to 45 C when the LE
6. defect be observed on the product please inform your usual contact person in as much detail as possible so that a customer service form can be completed If the defect is visible it is advisable to take photographs of it In the event of a proven defect Axess Vision Technology will replace the product s 9 Malfunctions The LEDs do not light up or there is no image The connector is probably not connected properly in the Box Check that the connector clicks in properly in the Box and that the Box lights up Refer to the user manual for how to use the Box Obstructed channel Clean the working channel using a cleaning brush or rinse it by injecting sterile saline solution into it using a syringe If you cannot remove the obstruction from the working channel prepare a new endoscope Poor suction The valve that is meant to block the biopsy Y piece union is damaged or assembled incorrectly Change or refit the valve 10 What the icons on the Broncoflex label mean For single use only do not re use sy Do not resterilise Sterilised by ethylene oxide EO Product manufacturer Number of items in the packaging hd Do not use if the packaging is open Consult the user manual for how to use this product Batch number Conformity marking as per the European Medical Device Directive 90 42 EEC together with the identification number of the notified body SGS mm 11 Standards applied The Broncoflex works in accordance with
7. department internal medicine etc The physician must be capable of carrying out the planned endoscopy and endoscopic treatments in complete safety in line with the directives set by the society of endoscopy etc with account taken of the risks of complications associated with endoscopy and endoscopic treatment This user manual does not provide any explanations or information about endoscopic techniques in themselves Accessories The accessories used via the working channel such as biopsy forceps can have an effect on the performances of the endoscope If a specific or highly specialised accessory is available from another supplier please contact Axess Vision Technology to have a compatibility test carried out prior to using it in the endoscope The maximum external diameter of an endoscopic accessory must be at least 0 2 mm less than the specified diameter of the working channel of the Axess Vision Technology endoscopes The functional length of an endoscopic accessory must be about 30 cm more than the functional length of the endoscope Substances used The Broncoflex working channel is compatible with the substances usually used during a bronchoscopic examination Precautions of use e Check that the packaging is fully intact prior to use If the packaging is damaged the devices it contains must not be used e Prior to use check each Broncoflex consumable for any signs of deterioration If the product is damaged do not use the dev
8. ewe ee ea aE EEE E E E E EEEE Eeri 12 Manufacturer s and distributor s contact details scsssssssssscccccccccceesssssssssssssceeeesccccoeeaeessssssssseceesseseoseaeees User manual for the Broncoflex You must read this document carefully 1 Introduction Scope This video bronchoscope has been designed to provide optical visualisation of an adult s airways using a monitor or tablet The airways include the organs tissues and organ systems the nasal passages windpipe and the bronchial tree beyond the primary bronchi Instruments are introduced through the mouth or nose when indications consistent with the requirements of the procedure are observed in adult patients The Broncoflex must not be used for any other purpose than the one described here User manual This user manual contains key information for the optimum use of this product in complete safety Read this manual carefully as well as the manuals of all the other instruments being used and use them accordingly Keep all of the user manuals in a safe place that is easy to access If you have any questions or comments to make about this user manual please contact Axess Vision Technology This manual describes the recommended inspection and preparation procedures prior to using the equipment as well as those concerning its cleaning and maintenance after use It does not describe how to carry out a given procedure nor does it set out to teach a beginner the cor
9. ice e The product must be handled and used by qualified staff with the utmost care e Check that the Up Down tip deflection lever and handpiece clamp work properly e Check that the working channel cap is in place N p tl User manual for the Broncoflex e Clean the lens with an optical cloth if necessary e When handling the product make sure the aseptic techniques are followed stringently e Should it prove difficult to introduce the Broncoflex into the bronchi or a probe do not force it but try to find out why this is the case before continuing e Carefully select the size of the intubation probe according to each patient Make sure that the compatibility of the Broncoflex with all of the accessories without electricity supply has been checked prior to use each time Do not use the device while the patient is being administered highly flammable anaesthetic gas Do not use the device during defibrillation The use of the following is strictly prohibited endotherapy accessories with electricity supply with the bronchoscope active endoscopic accessories such as laser probes or electrosurgical equipment Handle sharp or pointed tools carefully so as not to damage the flexible tube of the endoscope Make sure there is a similar system to hand as back up so that the procedure can continue in the event of malfunction The Broncoflex is thrown away in the designated container for contaminated disposable instruments after use
10. rect technique or medical aspects concerning the equipment s use It is up to each medical establishment to make sure that only staff who are fully trained in the theoretical and practical aspects competent and instructed in how to use endoscopic equipment antimicrobial agents processes and the hospital protocol for controlling infections are involved in the sterilisation or otherwise of these medical devices The known risks and or potential injuries associated with flexible endoscopic procedures are primarily as follows perforation infection and haemorrhage It is vital that all of the instructions given in this user manual are followed with the utmost care Poor understanding of these instructions could cause serious injury or even death in the patient serious injuries in the user serious injuries in a third party damage to the equipment Training and qualification of the user Before the system is supplied training is given by staff who have been certified by Axess Vision Technology If there are official standards concerning the user s qualification for carrying out endoscopy and endoscopic treatments which have been defined by the medical administration or other official institutions such as the society of endoscopy they must be complied with If there are no such standards this instrument must only be used by a physician who has been accredited by the head of the hospital s accident prevention department or head of the corresponding
11. the following regulations e European Medical Device Directive 93 42 EEC e IEC 60601 1 Medical electrical equipment Part 1 General requirements for basic safety and essential performance Keep away from sunlight and UV rays vin Keep dry Storage temperature Product expiry date 7 User manual for the Broncoflex e IEC 60601 2 18 Medical electrical equipment Part 2 18 Particular requirements for the basic safety and essential performance of endoscopic equipment e IEC 60601 1 2 Medical electrical equipment Part 1 2 General requirements for basic safety and essential performance Collateral Standard Electromagnetic disturbances Requirements and tests 12 Manufacturer s and distributor s contact details SA AXESS VISION TECHNOLOGY 3 rue Robespierre 37700 Saint Pierre des Corps FRANCE Tel 33 0 2 47 34 32 90 Fax 33 0 2 47 34 32 99 Represented by R gis Olivier as Managing Director Email info axessvisiontechnology com Axess Vision Technology attests to the conformity of its equipment in terms of both its design and manufacture according to the applicable standards Copyright 2010 SA AXESS VISION TECHNOLOGY All rights reserved Any reproduction even partial of this document by any means whatsoever electronic photocopy printer magnetic tape disk CD Rom or other is prohibited without prior written permission from SA AXESS VISION TECHNOLOGY User manual for the Broncoflex
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