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2. Notes for Using the Instrument

-21-

Environment of Use

• Do not install or store the camera or leave it standing in an adverse environment such as where the

temperature and humidity levels are high. Doing so may cause misoperation and/or malfunction. Be sure
to follow the instructions on page 9 when selecting the installation location.

• Dust in the air will not only attach to the objective lens, also to the optical parts inside the instrument.

You will not be able to take a good image when dust is on these parts. Please keep the room dust free.

Installation

• Please ask your sales representative or local Canon dealer to perform installation of this product.
• Please handle this product carefully. The adjustment can be altered if it is subjected to a strong shock or

jolt.

• If this product will be transported in an automobile or shipped a long distance, protective measures need

to be taken against vibrations and shocks. Ask your sales representative or local Canon dealer for more
information.

Others

For USA

Rx only-Caution:
Federal law restricts this device to sale by or on the order of a licensed practitioner.
Intended Use:
CF-1 is intended to be used for taking digital images of the retina of human eye with a mydriatic.

For European Union

Intended Use:
This medical device is intended to observe, image and record the retinal fundus through the pupil without
contact with the subject’s eye for the purpose of diagnosis by way of producing fundus image information.

000_L-IE-5152E_CF-1.book Page 21 Monday, July 29, 2013 10:30 AM

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Содержание CF-1

Страница 1: ...Camera CF 1 Operation Manual Make sure you read this manual before using the instrument Keep this manual in a safe place so that you can use it in the future 000_L IE 5152E_CF 1 book Page 1 Monday July 29 2013 10 30 AM ...

Страница 2: ...is responsible for maintaining the privacy of image data 7 The power cable supplied is designed to be used solely with this camera Do not use it for any other product 8 Canon reserves the right to change the specifications configuration and appearance of the product without prior notice CANON INC 2010 All rights reserved Under copyright laws this manual may not be copied in whole or in part withou...

Страница 3: ...or EU Countries The following mark shows compliance of the instrument with Directive 93 42 EEC This instrument is CLASS I EQUIPMENT according to EN 60601 1 2006 and IEC 60601 1 2005 The following mark indicates that the instrument is Type B Applied Parts forehead rest and chin rest according to EN 60601 1 The degree of protection against ingress of water is IPX0 This equipment is not suitable for ...

Страница 4: ...ghted radiance on the pupil of examinee s eyes in each wavelength La gives the measure for eyes in which the crystalline lens has been removed aphakes or for eyes of infants Lb gives this measure for eyes in which the crystalline lens is in place except for infants Spectrally weighted photochemical radiances La and Lb give a measure of the potential that exists for a beam of light to cause photoch...

Страница 5: ...e time Since La and Lb of this instrument are extremely low the risk of the photochemical hazard is also very low While no acute optical radiation hazards have been identified for this instru ment it is recommended that the intensity of light directed into the examinee s eye be limited to the minimum level which is necessary for diagnosis Infants aphakes and persons with dis eased eyes will be at ...

Страница 6: ...eeds special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the manual 2 Portable and mobile RF communications equipment can affect medical electrical equipment 3 Information regarding the cable affecting EMC is as follows To maintain the optimum EMC performance use only the designated cables 4 The use of accessories transducer...

Страница 7: ...SPR 11 EN 55011 GROUP 1 The CF 1 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 electromagnetic equipment RF emissions CISPR 11 EN 55011 Class A The CF 1 is suitable for use in all establishments other than domestic and those directly connected to the public low voltage power supply network that supplies ...

Страница 8: ...l mode 2 kV common mode Mains power quality should be that of a typical commercial or hospital environ ment Voltage dips short interruptions and voltage variations on power supply input lines EN IEC 61000 4 11 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 sec 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 7...

Страница 9: ... following sym bol NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflections from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless tele phones and land mobile radios amateur radio AM and FM radio...

Страница 10: ...80 MHz 800 MHz 800 MHz 2 5 GHz 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 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the...

Страница 11: ...peration manual utilizes the symbols and text shown below in warnings and cautions Read the meanings of these caution signs and the Safety Precautions see page 12 and follow the safety instructions WARNING This indicates a potentially hazardous situation which if not heeded could result in death or serious injury to you or others CAUTION This indicates a hazardous situation which if not heeded may...

Страница 12: ... environment High temperature or humidity Freezing or condensation CAUTION Do not cover the vent holes on the cover Otherwise the temperature in the instrument may rise and cause fire CAUTION Place the instrument on a firm table Do not place it extremely near the edge of a table or it may fall and cause damage or injury Installation Operation WARNING Do not connect the instrument except in the man...

Страница 13: ...ny time avoid putting any obstacles near the outlet Handling WARNING Never disassemble or modify the product as it may result in fire or electric shock Also since the instrument incorporates high voltage parts that may cause electric shocks and other hazardous parts touching them may cause death or serious injury WARNING Do not place anything on top of the instrument Otherwise the object may fall ...

Страница 14: ... may occur When Problem Occurs WARNING Should any of the following occur immediately turn OFF the power of each instrument unplug the power cable from the AC outlet and contact your sales representative or local Canon dealer When there is smoke an odd smell or abnormal sound When liquid has been spilled into the instrument or a metal object has entered through an opening When the instrument has be...

Страница 15: ...ad Otherwise fire or electric shock may result WARNING Use multiple portable socket outlets only for supplying power to equipment that is intended to form part of the system Otherwise fire or electric shock may result WARNING Do not connect non medical electrical equipment that has been supplied as a part of the system to any power socket other than the multiple socket outlets for the system Other...

Страница 16: ...bels and Markings on the Instrument The CF 1 has a label on it The label contents and its position are indicated below For 110 120V Countries For 230 240V Countries 000_L IE 5152E_CF 1 book Page 16 Monday July 29 2013 10 30 AM ...

Страница 17: ...er 25 4 2 Unlock the stage unit 26 4 3 Adjust the viewfinder 26 5 Photography 27 5 1 Photography modes 27 5 2 Color photography mode 28 5 3 Red free Photography Mode 34 5 4 OPTION Photography Mode 35 5 5 Fluorescein Angiography Mode 36 6 Photography auxiliary functions 38 6 1 Using the focus indicator 38 6 2 2 photography function 38 6 3 Small pupil photography function 39 6 4 Diopter compensation...

Страница 18: ...ead rest 49 7 3 4 Cover 50 7 4 Refilling the Chin Rest Paper 51 7 5 Power Cable Connections 52 7 6 Installing and Removing the EOS Digital Camera 53 7 6 1 Installing the EOS Digital Camera 53 7 6 2 Removing the EOS Digital Camera 54 7 7 Connecting the USB Cables 56 7 8 Carrying the instrument 57 8 Service Information 58 9 Main Specifications 59 10 Components 60 11 EN IEC60601 1 6 2010 Equipment Ap...

Страница 19: ...he pupils have a field angle of 50 and a diameter of 5 2 mm or greater If it is difficult to dilate the pupil of a patient s eye the small pupil photography function enables photographs to be taken of pupils with a diameter of ø4 3 mm or greater System optimized for digital photography By using the Retinal imaging control software MYD hereinafter called control software the images photographed by ...

Страница 20: ... good picture when the objective lens is dirty If the EOS digital camera is removed and left unattached dust and other foreign objects can enter the main unit and the EOS digital camera Always be sure to attach the caps to the respective mounts Cleaning and Disinfection Do not let the tip of a blower touch the objective lens Do not wipe off or rub the objective lens when there is dust or other sub...

Страница 21: ...e handle this product carefully The adjustment can be altered if it is subjected to a strong shock or jolt If this product will be transported in an automobile or shipped a long distance protective measures need to be taken against vibrations and shocks Ask your sales representative or local Canon dealer for more information Others For USA Rx only Caution Federal law restricts this device to sale ...

Страница 22: ... for photography e Chin rest Place the patient s chin on this rest f Diopter compensation lever Used when the target is not brought into focus by turning the focus knob g Focus knob Used for focusing on the patient s eye h Finger guard This is a guard which prevents the patient from grasping the head rest i Indentation for lift To carry the camera hold these parts at the left and right of the main...

Страница 23: ...f the chin rest p Pan tilt grip Use when adjusting the camera angle from side to side and up and down q Tilting lock lever Loosen this lever when adjusting the camera angle in the vertical direction r Panning lock knob Loosenthisknobwhenadjustingthecameraanglefromsidetoside s Operation panel 3 2 Operation Panel see page 24 t Stage unit lock button Locks and unlocks the stage unit u USB connector T...

Страница 24: ...intensity g TIMER C switch Starts and stops the timer When the timer has started the buzzer sounds each second and the lamp lights brightly The elapsed time is displayed by the control software Can be used only when fluorescein angiography mode is selected for the photography mode h Focus indicator switch Switch to use the focus indicator or not The lamp lights brightly when the focus indicator is...

Страница 25: ...eration panel have been operated for 10 or more minutes while power is supplied to the camera When none of the switches on the operation panel have been operated for 1 or more minutes after the operation to stop the timer has been performed during fluorescein angiography photography When the power saving function has been activated the POWER lamp on the operation panel blinks To restore normal ope...

Страница 26: ...rwise focusing will not be able to be performed correctly Turn the viewfinder diopter compensation ring all the way counterclockwise until it stops Then look into the viewfinder with one eye and look into the distance with the other eye Turn the diopter compensation ring all the way to the side and then gradually turn toward the side until the cross hair lines in the field of view appear sharpest ...

Страница 27: ...res Color photography see page 28 Select this mode to take color fundus images The small pupil function can be used Red free photography see page 34 Select this mode to take red free fundus images The small pupil function can be used OPTION photography see page 35 Select this mode to perform OPTION photography using the exciter filter for fluorescein angiography The small pupil function can be use...

Страница 28: ...ve the patient sit down Have the patient place his or her chin against the chin rest and his or her forehead against the forehead rest 5 Align the height of the patient s eye Move the chin rest up or down so that the patient s eye is aligned with the height adjustment mark CAUTION To prevent the risk of infection wipe the forehead rest with a disinfectant such as ethanol or glutaraldehyde for each...

Страница 29: ...eirs may be pinched possibly resulting in injury CAUTION When adjusting the position of the main unit in the front back direction slowly bring the main unit closer to the patient while looking at the patient s eye from the side You may injure the patient s eye if the objective lens makes contact with it Direction Operation Height Turn the operation lever Side movement While holding the operation l...

Страница 30: ...main unit When the split lines are not visible Part of the split lines may not be visible if the pupil diameter is small In this case press the small pupil photography switch to turn ON the small pupil photography function see page 39 Concerning the linkup function of the working distance dot Using a setting in the control software the working distance dot and split line operations can be linked u...

Страница 31: ...nnot be performed using the focus indicator In this case use the diopter compensation function see page 39 to focus with the cross hair line in the viewfinder When bringing the target into exact focus When bringing the target into exact focus the focus indicator serves as the general guideline for focusing To bring it into focus even more exactly focus on the target in such a way that the cross ha...

Страница 32: ...ready status of the fundus camera is indicated by the color of the photography ready lamp This status differs depending on the photography mode and image taking conditions 2 photography range 2 display Photography ready lamp Color Description Green Images can be taken Up to 10 images can be taken continuously when in the fluorescein angiography mode Orange Images can be taken but if image taking i...

Страница 33: ...he stage unit lock button is pressed the stage unit can be locked or unlocked in the following two places Standard Increased by 87 equivalent to a step of 0 9 of the standard Increased by 52 equivalent to a step of 0 6 of the standard Increased by 23 equivalent to a step of 0 3 of the standard Reduced by 19 equivalent to a step of 0 3 of the standard Reduced by 34 equivalent to a step of 0 6 of th...

Страница 34: ... Mode indicator lamp RED FREE lights up 3 Disinfect the forehead rest and replace the chin rest paper 4 Have the patient sit down 5 Align the height of the patient s eye 6 Align the camera to the eye to be photographed 7 Align the camera position 8 Adjust brightness in field of view for observation 9 Determine the area to be photographed 10 Focus on the patient s eye 11 Select the photography rang...

Страница 35: ...lect the OPTION photography mode Select OPTION with the MODE switch Or select the photography mode in the control software The COLOR and FLUO mode indicator lamps light up 3 Disinfect the forehead rest and replace the chin rest paper 4 Have the patient sit down 5 Align the height of the patient s eye 6 Align the camera to the eye to be photographed 7 Align the camera position 8 Adjust brightness i...

Страница 36: ...r 4 Have the patient sit down 5 Align the height of the patient s eye 6 Align the camera to the eye to be photographed 7 Align the camera position 8 Adjust brightness in field of view for observation 9 Determine the area to be photographed 10 Focus on the patient s eye 11 Select the photography range Concerning the barrier filter During retinal observations in the fluorescein angiography mode each...

Страница 37: ...status check the focus again and press the shutter release button To take images continuously hold down the shutter release button Images can be taken continuously for up to 10 seconds at a rate of one frame per second 14 Review the image 15 Stop the timer Press the TIMER C switch The elapsed time display is reset 16 End the study 17 Lock the stage unit 18 Turn OFF the power of the main unit 000_L...

Страница 38: ...function is operational the 2 lamp lights up and at the same time 2 and a green display appear at the bottom inside the viewfinder When images are taken in this status a range equivalent to one fourth of the observation screen at the center 2 photography range is stored The stored images will be enlarged and displayed on the monitor by the control software Field angle is equivalent to 43 Focus ind...

Страница 39: ...t into focus by turning the focus knob use the diopter compensation lever to insert the diopter compensation lens and take the photographs Given below is the diopter range in which images can be photographed 0 position 10 to 15 D position 7 to 31 D position 11 to 33 D However since the focus indicator see page 38 cannot be used when the diopter compensation lever is set to the or position turn the...

Страница 40: ...ng lock lever to the position and then adjust the angle of the digital retinal camera main unit in the vertical direction The lever clicks into position when it is at the horizontal setting so it is easy to check the horizontal position Before carrying the camera around turn the tilting lock lever to the position Note Hold the pan tilt grip when adjusting the camera angle by panning or tilting Not...

Страница 41: ...s representative or local Canon dealer It is recommended that you either copy the tables 7 1 1 and 7 1 2 on the following pages or create a separate checklist for recording the inspection results WARNING The instrument must be repaired by a qualified engineer only If the instrument is not repaired properly it may cause fire electric shock or accident CAUTION For safety reasons be sure to inspect t...

Страница 42: ...so be sure to plug in cables between equipments as far as they will go Main unit Check that the cover and parts are not damaged or loose Pass Fail Pass Fail Pass Fail Contact your sales representative or local Canon dealer if the cover and parts are damaged or loose Grasp the operation lever and tilt it back and forth and from left to right checking that the stage unit moves smoothly Check that th...

Страница 43: ...tive or local Canon dealer if the POWER lamp fails to light even though the power cable is connected properly Check that there is no dirt or scratches on the objective lens Pass Fail Pass Fail Pass Fail Clean the lens if it is dirty see page 48 Contact your sales representative or local Canon dealer if it is scratched Place a sheet of paper in front of the objective lens turn the brightness adjust...

Страница 44: ...er on image Place a sheet of paper in front of the objective lens and take a test image in the following conditions Conditions Flash intensity Standard pos Diopter comp lever 0 Focus knob Turn the knob on the right viewed from you all the way clockwise Then check that there is no foreign matter present on the image that can affect image readings Pass Fail Pass Fail Pass Fail Clean the objective le...

Страница 45: ...uit breaker and reset the circuit breaker The cable is cut Turn OFF the power to the main unit and contact your sales representative or local Canon dealer When the power is turned on 3 short beeps sound and the display lamps on the operation panel blink A system error has occurred Turn off the power to the main unit and contact your sales representative or local Canon dealer The external eye fixat...

Страница 46: ...de the range of 10 to 15 D Turn the focus knob to focus so that the cross hair lines in the field of view and the fundus image can be seen clearly at the same time Sharp images cannot be taken The pupil is not dilated enough Dilate the patient s pupil If the pupil is still too small press the small pupil photography switch to activate the small pupil function The positioning is not correct Perform...

Страница 47: ...raphed images The objective lens is dirty Clean the lens see page 48 The patient s eyelashes have appeared on the images Instruct the patient to open his or her eye wider Take another image Problem Cause Remedy 000_L IE 5152E_CF 1 book Page 47 Monday July 29 2013 10 30 AM ...

Страница 48: ...h the objective lens Use the procedure below to clean the objective lens when it is dirty Please order the lens cleaning paper lens cleaner and blower from your sales representative or local Canon dealer 1 Turn ON the power of the main unit Press the power switch to the I side 2 Adjust the brightness Set the brightness adjuster in the 8 to MAX range 3 Check for any dust or dirt Look at the objecti...

Страница 49: ...l the dirt is removed and the cleaner is completely wiped off 7 3 2 Viewfinder Note Do not let the tip of a blower touch the viewfinder lens If the viewfinder is dirty use the blower to blow off any dirt or dust on the lens surface 7 3 3 Forehead rest Disinfect the forehead rest for each patient CAUTION To prevent the risk of infection wipe the forehead rest with disinfecting ethanol for each pati...

Страница 50: ...pe the instrument with cleanser Soak a soft cloth with diluted neutral cleanser and wring it out 4 Wipe off the instrument with a rinsed cloth Wipe the instrument with a cloth that has been dipped in water and wrung out WARNING When the instrument is going to be cleaned be sure to turn OFF the power and unplug the power cable from the AC outlet Never use alcohol benzine thinner or any other flamma...

Страница 51: ...ead rest 1 Pull out the chin rest right and left holding pins 2 Insert the holding pins in the chin rest paper Insert the holding pins in the right and left holes of the chin rest paper About 100 sheets of paper can be mounted 3 Attach the chin rest paper to the chin rest Attach the chin rest paper with holding pins attached to the chin rest 000_L IE 5152E_CF 1 book Page 51 Monday July 29 2013 10 ...

Страница 52: ...wer supply described in the specifications Otherwise it may result in fire or electric shock WARNING Be sure to turn OFF the power before plugging or unplugging the cables as indicated in this manual Also do not handle the cables with wet hands Otherwise you may get an electric shock that may result in death or serious injury CAUTION Before connecting or disconnecting the cables be sure to hold th...

Страница 53: ... the retinal camera to the O side OFF 2 Remove the power plug from the AC outlet 3 Attach the DC coupler to the EOS digital camera Open the battery compartment cover on the EOS digital camera and attach the DC coupler After attaching the DC coupler pass the cord through the DC coupler cord hole and then close the battery compartment cover 4 Mount the EOS digital camera to the main unit Align the E...

Страница 54: ...ng the EOS Digital Camera Note If the EOS digital camera is removed and left unattached dust and other foreign objects can enter the main unit and EOS digital camera Be sure to always attach the caps to the respective mounts 1 Turn OFF the power of the retinal camera Press the power switch of the retinal camera to the O side OFF 2 Remove the power plug from the AC outlet 3 Remove the camera cover ...

Страница 55: ...e the DC coupler Open the battery compartment cover on the EOS digital camera and then slide the battery lock lever to remove the DC coupler After removing the DC coupler close the battery compartment cover 7 Attach the cap to the camera mount Attach the mount cap to the camera mount Also attach the body cap to the lens mount of the EOS digital camera 000_L IE 5152E_CF 1 book Page 55 Monday July 2...

Страница 56: ...connector at the other end of the USB cable firmly into the computer s USB ports Note Use the following type of USB cable Communication may not be possible if any other kind of cable is used Cable with type AB connector plug supporting USB 2 0 Hi Speed maximum length of 3 meters For further details contact your sales representative or local Canon dealer Note When connecting the USB cable pass it u...

Страница 57: ...pping the indentations for lift at the left and right of the bottom panel and carry the unit horizontally WARNING When the instrument is going to be moved be sure to turn OFF the power unplug the power cable from the AC outlet and disconnect other cables Otherwise the cable may be damaged fire or electric shock may result Also when the instrument is going to be carried be sure to tighten the stage...

Страница 58: ...r Repair Performance parts parts required to maintain the functioning of the product will be stocked for eight years after discontinuance of production Expendable Parts Replaced by Service Person The following parts are apt to become worn out or to deteriorate due to the characteristics of their material or structure These parts cannot be replaced by the user If these parts are found to be worn ou...

Страница 59: ...separately Eye fixation lamp External eye fixation lamp Internal Eye Fixation Target sold separately Working range Stage horizontal movement 110 mm side to side 65 mm front and back Main unit vertical movement 30 mm Chin rest vertical movement 60 mm Panning 30 to the right and left Tilting 15 up and 10 down Environment requirements Use Temperature 10 C to 35 C Humidity 30 to 80 RH no condensation ...

Страница 60: ...D ROM Retinal imaging control software MYD 1 Operation manual CF 1 control software 1 each DICOM conformance statement 1 Software license agreement 1 Warranty card for USA model only 1 WEEE directive leaflet for EU model only 1 Installation report 1 Optional Units Internal eye fixation target Stereo unit Chin rest paper 500 sheets 000_L IE 5152E_CF 1 book Page 60 Monday July 29 2013 10 30 AM ...

Страница 61: ...isfied the appropriate educational and or qualification level b Sex Male female c Weight No restriction d Educational level General knowledge of ophthalmology e Skills knowledge Skills and knowledge to understand the information in the operation manual No special training is required f Language ability Capable of understanding English vocabulary g Experience Guided by an experienced technician man...

Страница 62: ... 62 000_L IE 5152E_CF 1 book Page 62 Monday July 29 2013 10 30 AM ...

Страница 63: ...000_L IE 5152E_CF 1 book Page 63 Monday July 29 2013 10 30 AM ...

Страница 64: ...elephone 1 949 753 4160 CANON EUROPA N V Medical Products Division Bovenkerkerweg 59 1185 XB Amstelveen The Netherlands Telephone 31 20 545 8926 CANON SINGAPORE PTE LTD Medical Equipment Products Division 1 Harbour Front Avenue 04 01 Keppel Bay Tower Singapore 098632 Telephone 65 6799 8888 CANON AUSTRALIA PTY LTD Optical Products Division 1 Thomas Holt Drive North Ryde Sydney N S W 2113 Australia ...

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