Notice Digibox - GB - 20150225
Contents
1. USB USB 2 0 type B connector for communication and display on the tablet Switch Jack 3 5mm not used 5V DC D Om 5V DC 500 mA supply connector for stand alone use without tablet with display on a video screen Video NTSC format video output signal amplitude 1V peak 1 3 Connector identification symbols on the front panel of The Digibox The front panel of the Digibox contains a connector marked Broncoflex for connecting the single use consumable Broncoflex 2 SAFETY WARNINGS AND OR PRECAUTIONS TO BE TAKEN WARNING indicates a potentially hazardous situation Ignoring it may damage the appliance and can cause physical injury or even death Note On medical equipment this safety signal is only used if there is no other safety signal corresponding to the hazard NOTE indicates information or a comment 3 IMPORTANT INFORMATION TO BE READ BEFORE USE 3 1 Application fields The Digibox is designed to be used with sterile and single use video consumables supplied by the manufacturer and with a central unit that is not supplied The central unit can be a tablet or a medical video monitor This product is reserved exclusively for bronchoscope examinations and was developed by Axess Vision Technology The Digibox is intended to control the single use sterile endoscope and to supply a video signal for a medical monitor or a digital signal for a tablet or a comp2. AXESSVIS TECHNOLOGY Digibox user manual C Size The latest revision of this user s manual dates from 11 February 2015 Contents T CLGDGIS ONG symbols ace sete nie Leach cae evavanant apt dew usa tudes a a a a A a adaa aaaea 1 1 1 Label on the Digibox 1 1 2 Connector identification symbols on the rear face of The Digibox 1 1 3 Connector identification symbols on the front panel of The Digibox 2 2 Safety warnings and or Precautions to be taKen ssscscsssssesesssesesesesesesesesesessssssssssssssssseesenees 2 Important information to be read before USC ssscccessssccccesssssccccssssccccesssssccccsssscecsssscsceasssssees 2 3 1 Application fields 2 3 2 User Manual 2 3 3 User s qualification 3 3 4 Compatibility of instruments 3 3 5 Repairs and modifications 3 3 6 Safety instructions 3 3 7 Contraindications 4 4 Summary of the functions Of the DiGibOX ssscccsssscscsesssscccccssssccccesssssccccssssccccsssscsccessssesscsees 4 5 Checking the contents Of th packaging icccccssissessieveesicsssennsacssscsesacsvonensstesuceassusneussessseeasevencussiee 4 installation Gnd Connection ii cissesenssissncisesicsanssptoneavaoivicresnssccsbualasdnuunbasdecguiescasawes ceaiwaeasaviswesveaiene 6 6 1 Precautions before use 6 6 2 General inspection 6 6 3 Check the cables supply video USB etc 6 7 Description of the equipment and CONNECTION INSTUCTIONS ce0eesssscccessssccccesscsccccsssscccesssseess
3. No image or image If the fault persists go to solution 2 without colour Solution 2 Collect and another consumable Faulty consumable If the fault persists contact the manufacture s Service Department see 814 1 11 TRANSPORT STORAGE USE AND DISPOSAL 11 1 Transport storage and use conditions Relative humidity of the air without condensation Relative humidity of the air without condensation 70 C 158 F O C 32 F 10 Transport and storage conditions 90 40 C 104 F Conditions of use 30 85 The Digibox has a protection index of IP20 It should be stored sheltered from projections of foreign bodies with a diameter of Type of protection 12 5mm or more It is essential that it is stored sheltered from liquid projections because there is no protection against water drops 11 2 Cleaning The Digibox Use wipes with alcohol solutions or a nonabrasive cloth soaked in the liquid detergent commonly used in hospitals 11 3 Waste disposal In accordance with Directive 2002 96 EC covering waste electrical and electronic equipment WEEE The Digibox falls into category 8 of the WEEE Medical devices except for implanted and infected products To preserve the environment it is essential not to dispose of the Digibox electronic interface box with domestic waste but to dispose of it with electrical and electronic equipment via a process of reu
4. connected to the Digibox it automatically switches to the standby mode low consumption To switch off the Digibox disconnect the medical supply from the mains If an extension block is used to supply power to the Digibox check that it complies with the IEC 60884 1 standard make sure that it is not placed on the floor to prevent penetration by fluids or mechanical damage 7 2 3 Connection of the consumable Connect the single use consumable to the connector on the front panel of the Digibox marked Broncoflex 8 USE OF THE WHEN IT IS CONNECTED TO A TABLET When the Digibox is connected to a tablet it is essential to use the software sold by Axess Vision Technology to control it Refer to the user manual supplied with the software 9 USE OF THE DIGIBOX WHEN IT IS CONNECTED TO A MEDICAL VIDEO MONITOR The Digibox LED on the front panel of The Digibox indicates the state of the The Digibox and or of the consumable LED off When the power supply to The Digibox is cut off the LED on the front panel is off Blue LED When power to The Digibox is on the LED on the front panel is blue Standby mode Green LED If a new consumable is connected to The Digibox the LED lights up green and the image from the video is displayed on the medical video monitor Red LED If a consumable that has already been used is connected to the Digibox the RED LED flashes and the medical video monitor displays a black image It i
5. does not contain any parts that can be repaired by the user Entrust all maintenance and repairs to personnel qualified for the maintenance of the product 8 If a cable or wire is damaged or stripped replace it immediately with another of the same type and size supplied by the manufacturer The approvals and regulations apply to cables supplied by the manufacturer If the Digibox is exposed to liquids in a way contrary to the cleaning instructions or falls or if its box is damaged 9 there is a risk of electrocution or fire Cut off the power supply to the Digibox immediately and request the help of a technician from the manufacturer 10 Only use cables and accessories supplied by the manufacturer of the Digibox Use a cloth soaked in liquid detergent to clean the Digibox limiting your action to the outside surface of the box m Don t submerge the Digibox in liquid This causes safety risks when in use 12 Don t use the Digibox in the presence of flammable anaesthetic products Don t use pointed or hard objects to press the buttons on the front panel and or the keyboard keys This can 13 damage the buttons 14 Don t touch the electrical contacts in the Digibox electrical connector Don t use the Digibox in a room exposed to strong electromagnetic radiation e g close to medical equipment using microwaves or short waves MRI a radio or mobile phone This could diminish the performance of the p
6. observed by the operator Make sure that there is no unacceptable risk in the event of a fault or specific error of the supply of a 2 particular power or spectral frequency necessary for a specific diagnosis or therapy which is not identifiable by a trained operator procedure Make sure that the operator observes the active image rather than a saved image during an endoscope 13 3 Information concerning the electrical protection class The symbol o on the Digibox label shows the electrical protection class type The Digibox is class 2 and satisfies the following requirements e Protection provided by a combination structural arrangements making it unlikely that the 9 appliance ground will become live e Addition of extra insulation to the main insulation e Metal parts separated from live parts by the main insulation that is not accessible to the user e No possibility of grounding the chassis elimination of risks of contact potential 13 4 Information concerning electromagnetic compatibility EMC The Digibox is designed to be used in an electromagnetic environment as specified below The Digibox satisfies the EN 60601 1 2 2007 standard 13 4 1 Table 201 Electromagnetic emissions The Digibox is designed to be used in the electromagnetic environment specified below The customer or user of the Digibox must ensure that it is used in such an environment RF emissions CISPR 11 RF
7. 00 12 12 23 This guide does not apply to all environments Electromagnetic propagation depends on the absorption and reflection properties of floors objects and persons Portable and mobile RF communication equipment such as cell phones should not be used nearer to the equipment including cables than the recommended separation distance calculated using the equation below on the basis of the frequency of the transmitter 13 5 Attestation of conformity to the specifications required The manufacturer AXESS VISION TECHNOLOGY attests to the compliance of his equipment both from the points of view of design and of manufacture according to the directives and regulations in force He uses appropriate components taking into account e Their technical characteristics and their limitations e the intended use and the electromagnetic environment 14 MANUFACTURE AND DISTRIBUTORS 14 1 Manufacturers details 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 Email info axessvisiontechnology com 13 APPENDIX A TECHNICAL CHARACTERISTICS AND PERFORMANCE OF THE DIGIBOX ELECTRICAL CHARACTERISTICS AC DC adapter external mains Supply Fluctuation 100 240V 0 5 A Frequency 50 60 Hz Type of electrocution protection Class 2 MECHANICAL CHARACTERISTICS Dimensions Digibox case L 145mm x H 32mm x P 103
8. 6 7 1 Tablet version 6 7 1 1 Connection of the Digibox 6 7 2 Screen version 6 7 2 1 Connection of the medical video monitor 6 7 2 2 Connecting the supply and switching on the Digibox 7 7 2 3 Connection of the consumable 7 8 Use of the when it is Connected to tablet sesssccrcrssssccccsssscccccesssssccccssssccccssscecsesssssssccesses 7 9 Use of the Digibox when it is connected to a Medical video MONItOLS ccsesecssscccnsscncesscnceeses 7 10 List Of possible DIODICINS si ssissisiss tessecevsessucesdsiacavassianscassadssunsaaasiahsdssavaasiaetacsadeastishbansiebsddbsvaueays 7 10 1 Contact for the manufacturer s Service Department 7 11 Transport storage use ANA CiSPOSAI ssccressssscccccssssccccssssccccccssssccccssssccccesssscsecsssscsccasssescoens 8 11 1 Transport storage and use conditions 8 11 2 Cleaning The Digibox 8 11 3 Waste disposal 8 12 MGINCCNGNCE oeisidicsseciieksosceiviosebbecscatterceUercentsccedusescseiechevaindutidedUcetesseccodssvouscactardecestednavessdedineo es 8 12 1 Nature and frequency of maintenance and calibration 8 12 2 Return from maintenance 9 13 Technical informatio sessiis Po scesesaasaisdavis saute sducawarstasdaepaaidanedsaulwsdesasieelosaeisaduevede bes airaa sa a 9 13 1 List and length of cable 9 13 2 Requirements in relation to essential performance 9 13 3 Information concerning the electrical protection class 9 13 4 Information concerning electroma
9. e serious injury or even death in the patient serious injuries in the user serious injuries in a third party damage to the equipment 3 3 User s qualification If there are official standards concerning the user s qualification for carrying out bronchoscopy 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 department internal medicine etc The physician must be capable of carrying out the planned video 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 3 4 Compatibility of instruments This appliance complies with the specifications of the electromagnetic compatibility standard covering medical electrical appliances IEC 60601 1 2 2001 It is strictly forbidden to use powered endotherapy accessories including type BF and CF with the consumable The use of non compatible instruments may cause injury to the patient and inte
10. emissions CISPR 11 Harmonic emissions IEC 61000 3 2 Voltage fluctuations Flicker IEC 61000 3 3 13 4 2 Compliance Table 202 Electromagnetic immunity Electromagnetic environment Recommendations The Digibox uses RF energy only for its internal operation Consequently its emissions are very low and not likely to cause interference with neighbouring electronic equipment Class B Not applicable The Digibox is suitable for use in all premises including domestic premises and those directl linked to a low voltage public electricity suppl feeding buildings in domestic use Not applicable The Digibox is designed to be used in the electromagnetic environment specified below The customer or user of the Digibox must ensure that it is in such an environment IMMUNITY test Electrostatic discharge EDS IEC 61000 4 2 Fast transient burst surge IEC 61000 4 4 Test level IEC 60601 6 kV on contact 8 kV in the air 2 kV for electricity supply lines 1 kV or input output lines Level of conformity 6 kV on contact 8 kV in the air 2 kV for electricity supply lines 1 kV or input output lines Electromagnetic environment directives Floors should be made of wood concrete or ceramic tiles If floors are covered with synthetic material the relative humidity should be at least 30 The quality of the electricity supply circuit should be that of a typical commercial or hospital environmen
11. ent specified below The customer or user of the Digibox must ensure that it is in such an environment Test level according to IEC 60601 Immunity test compiace Electromagnetic environment directives e level Portable and mobile RF communication equipment should not be used nearer to any part of the equipment including cables than the recommended separation distance calculated using the equation below on the basis of the frequency of the transmitter Recommended separation distance d 124P 3 Veff 150 kHz to 80 MHz 3 V m 124p 80 MHz to 800 MH 80 MHz to 2 5 GHz 124 P z to z d IWP 800 MHz to 2 5 GHz where P is the maximum output power characteristic of the transmitter in watts W according to the transmitter manufacturer and is the recommended separation distance in metres m The field strength of fixed RF transmitters as determined by an electromagnetic survey on site should be less than the compliance level at each frequency range Interference can arise close to an appliance carrying the following symbol O NOTE 1 At 80 MHz and at 800 MHz the eyes frequency range applies NOTE 2 These directives cannot apply in all situations Electromagnetic propagation is affected by thel absorption and reflection of structures objects and persons It is not possible to predict theoretically the exact field strength of fixed transmitters such as radio telephone base stations cell phones wire
12. er if any item is missing For a description of the characteristics of the 4 o appliance refer to the appropriate section in 7 Compare the contents of the packaging with the elements shown below Check that all the accessories and components in the contents list are present and in good condition If a part of his damaged if an item is missing or if you have any questions contact the manufacturer directly and don t use the part in question 1 Digibox interface box e USB 2 0 type A B cable for 2 connecting the Digibox interface box to the tablet 2 gt gt m 3 Medical supply 4 Mains lead 5 RCA RCA video cable a ka 6 BNC RCA adapter i 7 Digibox V2 user manual Before using the AXESS VISION TECHNOLOGY video endoscope system check that the other applied parts of other medical appliances used with the configuration applicable to endoscopy appliances are type BF or CF applied parts 6 INSTALLATION AND CONNECTION 6 1 Precautions before use y Before use prepare the system thoroughly Failure to do this may cause risks of damaging the system injuring the patient and or causing a fire v Check the Digibox before every use as explained below v Also check the accessories that will be used with the Digibox in accordance with their respective user manuals Only use accessories supplied by the manufacturer v Ifyou see anything wrong don
13. gnetic compatibility EMC 10 13 4 1 Table 201 Electromagnetic emissions 10 13 4 2 Table 202 Electromagnetic immunity 10 13 4 3 Table 204 Electromagnetic immunity 12 13 4 4 Table 206 Recommended separation distances between portable and mobile RF communication equipment 13 13 5 Attestation of conformity to the specifications required 13 14 Manufacture and distributors icactinccesci i icisniatenativ inten eeciiiabataes ati ieek ees eines 13 14 1 Manufacturers details 13 APPENDIX A Technical characteristics and performance Of The DigibOX sssssccsssscccrssssceceessees 14 APPENDIX B List of functionalities Of The DigibOX sssssssssccccssssccccsssscscccsssssccccsssscsccessssssceesees 15 1 LABELS AND SYMBOLS 11 Label on the Digibox Safety labels and symbols are placed at the places shown below If any labels or symbols are missing please contact Axess Vision Technology The label serves for traceability and logistics it is also a Digibox safety label and gives a unique identification It is temporarily represented below l Axess Vision Technology 3 rue Robespierre 37700 Saint Pierre des Corps E E FRANCE i INPUT 5V 500 mA 1P20 Z CE Digibox The codification of the label icons is described in the table below Manufacturer This symbol shows the name and address of the manufacturer Date of manufacture This symbol shows the date of manufacture Serial number This symbol ind
14. icates the serial number in 9 characters figures Catalogue reference The manufacturers catalogue reference is located immediately after the symbol Appliance with the following electrical protection class This symbol indicates the type of class 2 electrical protection Appliance with upgraded insulation and no metal parts Class 2 equipment plugs do not necessarily have a ground pin Type BF applied part Type BF electronic device complying with the IEC 60601 1 standard Protection against electric shocks Operating instructions Refer to the user manual Do not dispose of with domestic waste Conformity marking as per the European Medical Device Directive 93 42 EEC together with the identification number of the notified body SGS a XOH E Also includes Directive 1999 5 EC covering radio equipment and telecommunications terminal equipment oN 7200 Input voltage 5V dc courant consumption 500 mA Symbol attesting to protection against the effects of temporary immersion in water in accordance with IEC 60529 IPN N2 with IPNIN2 NI 2 Protection against solid foreign bodies with a diameter of 12 5 mm or more N2 0 No protection for liquid bodies 1 2 Connector identification symbols on the rear face of The Digibox The rear face of the Digibox has 4 connectors for connecting the box to the elements of the medical 1 system USB Switch 59 Vid o m
15. less phones and land mobile radios amateur radios AM and FM radio receivers and television To evaluate the electromagnetic environment created by fixed RF transmitters an electronic survey on site should be envisaged If the field strength measured at the point of use of this device exceeds the RF compliance level above the operation of the device should be checked If problems are observed other measures may be necessary such as turning or moving The Digibox P In the frequency range from 150 kHz to 80 MHz the field strength should be less than 3 V m 12 13 4 4 Table 206 Recommended separation distances between portable and mobile RF communication equipment The Digibox is designed to be used in an electromagnetic environment in which the radio electric interference radiation is controlled The customer or user of the Digibox can contribute to preventing electromagnetic interference by maintaining a minimum distance between the portable and mobile RF communications equipment transmitters and the Digibox as recommended below depending on the maximum transmission power of the communication equipment Separation distance according to the transmitter frequency m Maximum assigned output calculated with V2 3 V and El 3 V m Be Pete di 150 kHzto 80 MHz 80MHzto 800 MHz 800 MHz to 2 5 GHz ss d 124P d 12VP E 2 23 7 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 1
16. mm Weight Digibox unit 0 6 Kg MISCELLANEOUS CHARACTERISTICS Protection index IP 20 Video standard analogue NTSC on RCA output Video output RCA USB interface Type A USB 2 0 amp Type B Video format digital MPEG H264 Accessories supplied with The Digibox USB cable amp RCA RCA video cable 14 APPENDIX B LIST OF FUNCTIONALITIES OF THE DIGIBOX 1 Real time video display 2 Detection of the re use of a single use sterile endoscope 3 USB 2 0 interface enabling viewing and saving of the video on a tablet 15 Copyright 2015 SA AXESS VISION TECHNOLOGY All rights reserved Any reproduction even partial of the page 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 info axessvisiontechnology com
17. returns must have prior authorisation from the manufacturer will indicate the procedure to be followed The Service Department will not accept warranty claims in the event of damage due to inadequate packing 7 DESCRIPTION OF THE EQUIPMENT AND CONNECTION INSTRUCTIONS 71 Tablet version 7 1 1 Connection of the Digibox When using the Digibox with a tablet connect the type B USB connector to the socket marked USB on the rear face of the Digibox and the type A connector to the tablet The USB 2 0 type A B cable connecting the tablet to the Digibox serves for the power supply to The Digibox and the transmission of the data flow for the images displayed on the tablet It is not necessary to connect the medical supply provided 7 2 Screen version 7 2 1 Connection of the medical video monitor Images from the Broncoflexe can be viewed on a medical video monitor accepting the NTSC standard via a composite video input Refer to the installation and user manual of the medical monitor used to connect the cable and select the appropriate input Connect one end of the cable to the RCA connector of the Digibox marked Video and the other end to the composite video input of the screen 7 2 2 Connecting the supply and switching on the Digibox Connect the medical supply cable to the Digibox connector the female connector of the mains cable to the medical supply and the male connector to a wall socket If no consummable is
18. rfere with the operation of the video bronchoscopy system 3 5 Repairs and modifications The Digibox does not contain any parts that can be repaired by the user It must not be dismantled modified or repaired by the user as this could cause injury to the patient or the user and or affect the operation of the video bronchoscopy system If the instructions in this manual do not enable you to remedy the problem encountered you should return the Digibox to the manufacturer for diagnosis and repair or replacement 3 6 Safety instructions For your protection against risk observe the warnings and cautions below when handling the Digibox You 1 should also observe the warnings and cautions in each chapter of this user manual 2 Observe the following precautions without fail Failure to do so puts the patient and the medical personnel at risk of electrocution 3 Don t place the Digibox close to a window Exposure to rain water moisture or constant direct sunlight can damage the appliance seriously 4 Don t place anything on the signal cable between the box and the medical video signal monitor The cable should be placed in an area where it will not be trodden on 5 Don t apply excessive pressure to the front panel of The Digibox You could damage it permanently 6 Don t apply excessive force to The Digibox and or other instruments connected to it This could damage the system and or cause faults The Digibox
19. roduct In cases of interference attenuation measures such as turning or repositioning the instrument or insulating the location may be necessary 15 We do not advise using the Digibox in the proximity of other appliances or stacking it on other appliances If 16 adjacent installation or stacking is necessary check that the Digibox is working properly in its intended configuration Don t touch the patient at the same time as the parts of the Digibox interface except for the insulated parts of 17 the endoscope 3 7 Contraindications Only use appliances listed in 0 for bronchoscopic observation or treatment Other combinations of 1 instruments can neutralise electrical insulation and seriously affect the cardiac functions of the patient and of the user doctor 2 Follow the precautionary measures described in the previous sections Failure to do so exposes the patient and the medical personnel to risks of electrocution 3 Don t use this equipment for cardiac applications 4 SUMMARY OF THE FUNCTIONS OF THE DIGIBOX The Digibox is an interface box between the consumable and the tablet or medical video monitor In this user manual the term Digibox always refers to the electronic interface box 5 CHECKING THE CONTENTS OF THE PACKAGING This chapter describes the components in the parcel delivered It may be used as a checklist when unpacking Contact the manufactur
20. s possible to reuse the consumable by pressing the small button on the left of the LED If a colour fault is observed on the image pressing the small red button on the left of the LED triggers automatic adjustment of the white balance to obtain a better rendering of the colours in the image This should be done once a white reference has been put in front of the camera a white sheet or other without touching the endoscope with it or you could create cross contamination After pressing the small white balance button the white sheet should be held in front of the camera as long as the white LED is active and then switch to green when the white balance is completed The consumable is for single use only Its reuse is under the user s responsibility 10 LIST OF POSSIBLE PROBLEMS 10 1 Contact for the manufacturer s Service Department For each of the following items checking procedures and actions are proposed They enable most problems encountered to be solved and limit calls to the manufacturer technician Nevertheless for any problem not solved contact the maintenance Department at AXESS VISION TECHNOLOGY Axess Vision tecunoLocy 3 rue Robespierre 37700 SAINT PIERRE DES CORPS Fr Tel 33 0 2 47 34 32 00 Fax 33 0 2 47 34 32 99 Solution 1 First check that the consumable has been detected Poor endoscope digital box LED on GREEN or flashing RED Disconnect and reconnect the connection consumable
21. se recycling or another form of reclamation of this electrical and electronic equipment If necessary return the Digibox to Axess Vision Technology who will handle its disposal the address for returns is given in 14 1 12 MAINTENANCE 12 1 Nature and frequency of maintenance and calibration The maintenance frequency is 12 months This preventive maintenance can only be performed by personnel qualified by the manufacturer No recalibration is required USB 2 0 A B Cable connecting the tablet to the Digibox Qualtek 1 CABLE MALE V l 2m BLACK 2M gt USB 2 0 certified type A Ref 3021007 06 male B male 2 Medical supply 3m dical l medical supply 240V Ref MENB1020A0503F01 bl CNC Tech z Digibox supply om Supply cable ae cable 7 Ref 0 75 14X BL EEC 777 IEC 320 C13 00200 i Pro Signal i a ER ay 2m Coaxial cable j Ref AV02595 Female BNC CA For connecting the RCA MULTICOMP 5 female RCA w 7 RCA toa medical video adapter G monitor Ref 25 7510 12 2 Return from maintenance It is recommended that the user check operation before putting the appliance back into service 13 TECHNICAL INFORMATION 13 1 List and length of cable The Digibox only operates with cables supplied by the manufacturer 13 2 Requirements in relation to essential performance The following requirements are checked and validated 1 Check the orientation of the images in the view
22. t 10 Transient overvoltage IEC 61000 4 5 Voltage dip short interruptions and voltage variations on the electricity supply input lines IEC 61000 4 11 Magnetic field at the electricity mains frequency 50 60 Hz IEC 61000 4 8 1 kV between phases 2 kV between phases and ground lt 5 Ur gt 95 dips of Ur during 0 5 cycle 40 Ur 60 dip of Ur During 5 cycles 70 Ur gt 30 dips of Ur during 25 cycles lt 5 Ur gt 95 dip of Ur for5s 1 kV between phases Not applicable class 2 lt 5 Ur 95 dips of Ur during 0 5 cycle 40 Ur 60 dip of Ur during 5 cycles 70 Ur gt 30 dips of Ur during 25 cycles lt 5 Ur gt 95 dips of Ur for5s NOTE Uz is the AC mains voltage before application of the test level The quality of the electricity supply circuit should be that of a typical commercial or hospital environment The quality of the electricity supply circuit should be that of a typical commercial or hospital environment If The Digibox user requires continuous operation during power cuts we recommend feeding The Digibox from an uninterruptible power supply or a battery The magnetic fields at mains frequency should have the characteristic levels of a representative place situated in a typical commercial or hospital environment 1 13 4 3 Table 204 Electromagnetic immunity The Digibox is designed to be used in the electromagnetic environm
23. t use the Digibox If the instructions in the chapter don t enable you to correct the fault contact the manufacturer Any material or other damage can put the patient or the user in danger and seriously damage the endoscope system v Makean inspection as described below Always consult the specific user manual for the product in question vy Only use accessories supplied by the manufacturer including supply components to prevent risks of electrical danger 6 2 General inspection No damage should be visible on the product e g the deformation or cracks The product should be clean The product should not carry any residues of cleaning or disinfectant products Make sure that no parts are missing and that all components are properly fixed Make sure that the connection elements between the instruments are in good working order Check that all the components of an instrument system are correctly assembled and fixed a ee ee a Before every use of the ENDOSCOPE check that the orientation of the images observed is correct 6 3 Check the cables supply video USB etc v Check that the cable is not broken v Check for faulty insulation v Check that the connectors are intact and carry no traces of corrosion Any instrument found faulty on unpacking should be returned in its original box If this is not possible pack each component separately in a sufficient quantity of paper or foam and place it in a box Product
24. uter displaying the image For more information on the Broncoflexe consumable refer to its user manual The Digibox should not be used for any other purpose 3 2 User Manual This user manual contains key information for the optimum use of Digibox in complete safety Read this manual and the manuals of the other instruments used and use them accordingly Keep all user manuals in a safe place with easy access If you have a question or comment about this manual don t hesitate to contact the manufacturer 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 correct 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 Follow all the instructions in this user manual carefully Poor understanding of these instructions could caus
Download Pdf Manuals
Related Search