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Electr

oma

gnetic Compa

tibility 

(IEC 60601-1-2)

11

11. Electromagnetic Compatibility (IEC 60601-1-2)

P11-2

[ Compliance verification and guidance ]

Guidance and manufacturer's declaration - electromagnetic emissions

The KOWA 

 is intended for use in the electromagnetic environment specified below.

The customer or the user of the KOWA 

 should assure that it is used in such an environment.

Emissions test

Compliance

Electromagnetic environment - guidance

RF emissions

CISPR 11

Group 1

The KOWA 

 uses RF energy only for its internal function. Therefore, 

its RF emissions are very low and are not likely to cause any interference in 
nearby electronic equipment. 

RF emissions
CISPR 11

Class A

The KOWA 

 is suitable for use in all establishments other than do-

mestic and those directly connected to the public low-voltage power supply net-
work that supplies buildings used for domestic purposes.

Harmonic emissions
IEC 61000-3-2

Class A

Voltage fluctuations/
flicker emissions
IEC 61000-3-3

Complies

Содержание VX-10a

Страница 1: ...KOWA INSTRUCTION MANUAL FUNDUS CAMERA KOWA VX 10 EU...

Страница 2: ......

Страница 3: ...njury burn electrical shock and so forth that will not necessitate hospitalization or long term outpatient treatment 2 Damage to property means an extensive damage to the house and or household goods...

Страница 4: ...harge short circuit disassemble deform heat or put into re the battery Do not connect the battery s and poles by wire Do not carry or store it closely together with metal necklace or the like Properly...

Страница 5: ...he patient s eyes may be injured When batteries are stored they must not be exposed to direct sunlight high temperature or high humidity Do not wipe the exterior of the instrument with solvent such as...

Страница 6: ...the poles by hand because there is a fear of patient s ngers being caught and injured Caution E Keep your ngers off the gap between the base s power housing and the horizontal arm There is a fear of y...

Страница 7: ...for Caution Symbol for Warning High voltage Symbol for Caution High temperature Symbol for MANUFACTURER Symbol for AUTHORISED REPRESENTATIVE IN THE EUROPEAN COMMUNITY Symbol for Type B applied part S...

Страница 8: ...recommended Replacement of components requiring regular replacement such as aluminum electrolytic capaci tor is supported as a paid service For more information about replacement of such components pl...

Страница 9: ...st be provided individually Do not route the power supply through other multi tap receptacle to the system or Multi tap with Isolation Transformer The power cable for an electrical device that compose...

Страница 10: ...ame type can cause the total PATIENT LEAKAGE CUR RENT to exceed limits See Note 1 Verify total PA TIENT LEAKAGE CURRENT 1bItems A and B are ME EQUIP MENT powered via a MULTI PLE SOCKET OUTLET A IEC 60...

Страница 11: ...nector hous ing for SIGNAL INPUT OUTPUT PART or SEPARATION DEVICE 3c Item A is ME EQUIPMENT and item B in is ME EQUIP MENT or non ME EQUIP MENT a Potential differ ence between PROTECTIVE EARTH CON NEC...

Страница 12: ...touch any of the instrument controls 5 The following items shall be considered after using the instrument 1 Turn OFF the instrument after setting control switches dials and so forth to their initial...

Страница 13: ...ries Dust cover 1 pc Instruction manual 1 Quick manual 1 External xation lamp 1 pc Hexagon wrench 2 pcs Pin 2 pcs Chin rest paper 1 set Fuse 2 pcs Observation lamp 1 pc Blower 1 pc Grip option Interna...

Страница 14: ...Introduction Introduction P0 12...

Страница 15: ...quipment Preparatory procedure Basic photography Other practical photography Handy features Troubleshooting Maintenance and inspection Specifications Technical references 10 Photochemical Hazard ISO 1...

Страница 16: ...ography of data card P4 3 4 5 Blue Eye button P4 3 5 Handy features P5 1 5 1 LCD monitoring mode mydriatic color and FA mode P5 1 5 2 External image input display function P5 2 5 3 Changing initial se...

Страница 17: ...ing into account the service environment of equipment 3 Automatic exposure system which can be automatically linked with a camera in use 4 Wide range ash of 0 6WS to 300 WS 19 steps for fully handling...

Страница 18: ...t be brought to the focus point of optical view nder the photogra pher must adjust the optical view nder to his or her eye beforehand Lower camera back mount 35 mm mount A mount for xing 35 mm camera...

Страница 19: ...mark Fitting part of internal xation target Fit internal xation target optional at its mount Field angle knob Used to select a eld angle of either 50 or 30 45 or 27 for non mydriatic photography Data...

Страница 20: ...trol knob 8 Flash intensity compensation indicating lamp These lamps indicate ash intensity compensa tion 9 Observation light intensity control knob Used to adjust observation light intensity Flash in...

Страница 21: ...nus it is not intend ed to compensate ash intensity E Fixation lamp buttons Used to select a desired xation lamp in non mydriatic mode F S P button Used to select small pupil photography in mydri atic...

Страница 22: ...input terminal connectable to external device when video camera is in use When the video camera is in use connect the external device to the fundus camera by designated synchronization cable When ima...

Страница 23: ...batteries unloaded from it Store batteries in a place where they can be protected from direct sunlight high temperature and high humidity Warning Obligatory Be sure to use accessory batteries When rep...

Страница 24: ...the lm will be automatically wound up as far as the rst frame is ready Make sure that frame counter indicates 01 5 After a desired number of frames have been exposed press the rewind button After rew...

Страница 25: ...meter of the pupil is 5 5 mm or more in mydriatic mode 4 0 mm or more in small pupil mode and 4 0 mm or more in non mydriatic mode Mydriatic photography is enabled if 5 5 mm or more in diameter Small...

Страница 26: ...e nose so forth Caution Prohibitory Be careful for a patient to be unable to touch the instrument except for grips and a head band In operating the fundus camera keep your ngers off the spaces or gaps...

Страница 27: ...ument is classi ed into non mydriatic mydriatic color mydriatic uorescein photography It is recommendable to grasp a rough operations ow along the purpose of each photography If malfunction should occ...

Страница 28: ...he remaining number of lm on the camera back of selected optical path In case of electronic image check the peripheral devices are ready 3 Check the remaining number 1 Non mydriatic button 2 Selection...

Страница 29: ...utton 5 Pull the base toward you 5 Set the position 5 Check pupil s diameter FA Color Blue Eye Check the examined eye s pupil for dilation and compensate the ash intensity if needed Pupil suf ciently...

Страница 30: ...movements such that luminous spots can come in the center of the lines Align the direction of longitudinal movement with a point where the luminous spots are is the smallest Luminous spots for detect...

Страница 31: ...be hard to watch adjust its angle so that it comes in front of your line of sight n Working camera back indicator Operations of the indicating lamp show the following Camera selected Display Descript...

Страница 32: ...us If you wear glasses look into the view nder with its rub ber adapter turned up Finder rubber adapter 1 Mydriatic color button 2 Diopter adjustment when you wear glasses FA Color Blue Eye 3 Select a...

Страница 33: ...lens buttton 7 Alignment positioning alignment FA Color Blue Eye 8 Adjusting the position of external xation lamp Adjust the position of external xation lamp such that it comes in a position as illust...

Страница 34: ...sition that will satisfy this lighting condition to the examined eye is very re stricted Flashlight travels on the same path as observation light So if you can observe the fundus under a uniform illum...

Страница 35: ...o leftward White re ection at right Camera positioned too rightward White are in peripheral Camera is too close to examined eye Shadow in peripheral Camera is too far from examined eye Shadow in local...

Страница 36: ...rt Simultaneously with uorescein injection into the vein press the timer button and measure the amount of time by the timer The timer will indicate the amount of time in a 5 digit number increasing 0...

Страница 37: ...s may not support this photography n Automatic insertion of exciter lter Upon pressing mydriatic fluorescein select button the blue exciter filter will be automatically inserted But another method is...

Страница 38: ...of 50 45 When luminous lines for focusing detection is in use adjust the focusing at the field angle of 50 45 You need not adjust focussing after changing the eld angle When video camera connecting a...

Страница 39: ...ll pupil mode Since photographing immediately after switching the mode does not allow you to capture a good image wait at least three seconds before starting photography 4 3 Red free photography mydri...

Страница 40: ...ographing normally data on the data card will be recorded on 35 mm lm The data card may be reused after wiping it off with alcohol 4 5 Blue Eye button This paragraph describes the Blue Eye button func...

Страница 41: ...g non mydriatic photography n In LCD monitoring mode you can perform non mydriatic photographing at a eld angle of 50 of the exam ined eye the pupil of which can be spontaneously dilated to 5 5 mm or...

Страница 42: ...of this unit Press the monitor select button on the right hand panel to switch the monitor display The image from the external imaging device connected to this unit is displayed Automatic display Man...

Страница 43: ...nel SW Description OFF ON SW 1 Start up mode when power is turned ON Non mydriatic Mydriatic SW 2 External video input Don t use Don t use SW 3 Counting sound when the timer operates Sounding No sound...

Страница 44: ...path Make sure mark is ON The buzzer is sounding to warn you of some wrong operation Remove lter from slot Shutter is not released with the video camera connect ing adapter The buzzer is sounding to...

Страница 45: ...ff Diopter lens inserted Remove diopter lens When the dioptic lens is inserted detect ing luminous dots turn off External fixation light does not come ON Fixation lamp for photographing posterior pole...

Страница 46: ...pupil Shadow around peripheral of picture Camera too far from the examined eye Properly adjust the fundus camera s alignment Whitening around peripheral of picture Camera too close to the examined ey...

Страница 47: ...zed off Lightly wipe the monitor screen cover with soft cloth such as gauze because it is open to scar Wipe off the obstinate dirt with soft cloth from which water or lukewarm water used to dilute a s...

Страница 48: ...which cannot be cleaned off with the mixture will be removed by lightly wiping the lens with cotton swab moistened with a small amount of water After this step fully wipe the lens with the solution al...

Страница 49: ...located at its base Fit the new lamp in the socket without applying any twisting force Press down the observation lamp deep into the socket to t it securely Fit the lamp cover while taking care that e...

Страница 50: ...amp straight from the direction of the three pins located at its base and then t a new one in the socket Do not apply any twisting force Press down the ash lamp deep into the socket and t it securely...

Страница 51: ...Use accessory or designated fuses If other than designated ones should be used there may occur failure or a re on the equipment 7 8 Fitting chin rest paper Set chin rest paper at the chin rest and x i...

Страница 52: ...t Visually confirm that there is no scratch or breakage on the power cord the cable between the main camera unit and the power unit as well as the one between the base and the power unit No scratch or...

Страница 53: ...Input Normal Powerconsumption Maximum 50 60Hz 280VA 1500VA Dimensions 400mm W 520mm D 620mm H Weight 35 5kg Compliance standard IEC 60601 1 2005 A1 2012 EN 60601 1 2006 A1 2013 IEC 60601 1 1988 A1 19...

Страница 54: ...dicated synchronous cables K9L SC48 D SUB D SUB 5m For connecting VK2 K9L SC48D K9L SC48 BNC Cable N 2 5m For connecting VK2D Caution If you intend to use external synchronization connector please con...

Страница 55: ...l a dilated pupil The retinal exposure dose for a photochemical hazard is a product of the radiance and the exposure time For in stance at a radiance level of 80mW cm2 sr 3 min irradiation of the dila...

Страница 56: ...function ing or the latter itself may malfunction Power cable a maximum length of 3 m Video Adapters made by Kowa Dedicated synchronous cables a maximum length of 5m Cameras with CE marking 3 This ins...

Страница 57: ...est Compliance Electromagnetic environment guidance RF emissions CISPR 11 Group 1 The KOWA uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to c...

Страница 58: ...environ ment Surge IEC 61000 4 5 1 kV line s to line s 2 kV line s to earth 1 kV line s to line s 2 kV line s to earth Mains power quality should be that of a typical commercial or hospital environ me...

Страница 59: ...distance in metres m Field strengths from fixed RF transmitters as determined by an electromagnetic site surveya should be less than the compliance level in each frequency rangeb Interference may occ...

Страница 60: ...um output power of transmitter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz d 1 2 P 80 MHz to 800 MHz d 1 2 P 800 MHz to 2 5 GHz d 2 3 P 0 01 0 12 0 12 0 23 0 1 0 38...

Страница 61: ...Electromagnetic Compatibility IEC 60601 1 2 11 11 Electromagnetic Compatibility IEC 60601 1 2 P11 6 For EU market...

Страница 62: ...Electromagnetic Compatibility IEC 60601 1 2 11 11 Electromagnetic Compatibility IEC 60601 1 2 P11 7...

Страница 63: ......

Страница 64: ...L http www kowamedical com Printed on recycled paper 3 1 Chofugaoka 3 chome Chofu Tokyo 182 0021 Japan 4 14 Nihonbashi honcho 3 chome Chuo ku Tokyo 103 8433 Japan Phone 81 3 3279 7639 Facsimile 81 3 3...

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