KOWA nonmyd WX Instruction Manual

Manual text content

INSTRUCTION MANUAL 2D/3D Non-mydriatic Retinal Camera Kowa KOWA nonmyd WX EU  Accept our congratulations on your purchase of KOWA nonmyd WX. KOWA nonmyd WX is a Non-mydriatic retinal camera for mono and stereo retinal photography. This manual provides a description of the operation procedures of KOWA nonmyd WX and important precautions to be observed during its use. Please read this manual carefully to assure that the instrument can demonstrate its full capabilities and work safely. After you have finished reading, keep this manual in an easily accessible location near the instrument for future refer - ence. Operational considerations for safety This manual describes important precautions to be observed when you use this system to assure that the system is used safely without causing any damage to the human body or property of the purchaser and other persons. The designations and pictorial symbols used in this manual have the following meanings. These should be fully comprehended before reading the text of this manual. Meanings of designations Warning If the instrument should be operated wrongly, there may incur a risk of causing death or serious injury. Caution If the instrument should be operated wrongly, there may result in a bodily injury *1 or damage to property *2 . k 1 A bodily injury means an injury, burn, electrical shock and so forth that will not necessitate hospi - talization or long-term outpatient treatment. k 2 Damage to property means an extensive damage to a house and/or household goods as well as a domestic animal and pet. Meanings of symbols Graphical indication of any danger (including warning and caution). What is warned is explicitly and pictorially indicated by a picture or its associ- ated message on or near a pictorial symbol. Graphical indication of prohibited operation (prohibitive item). What is prohibited is explicitly and pictorially indicated by a picture or its as- sociated message on or near a pictorial symbol. Graphical indication of any mandatory action (obligatory item). What must always be done is explicitly and pictorially indicated by a picture or its associated message on or near a pictorial symbol. Disclaimer Kowa is not responsible for: • Any damage caused by fire, earthquake, third party’s action, any other accident or user’s intentional or unintentional error, abuse or use under abnormal conditions. • Any damage resulting from use of the product or its malfunction (e.g. operating loss, shutdown, change/loss of stored data and so forth). • Any damage resulting from disobedience of what is described in this manual. • Any damage resulting from, for instance, malfunctioning of instrument caused by a combination of connected devices. Introduction  Warning Unplug If any abnormal smell, sound, overheating or smoke should be detected, be sure to turn OFF the main power immediately and then unplug the instrument from the power outlet. Continued use of the instrument may cause the instrument to malfunction or cause a fire. Con - tact Kowa or your Kowa dealer for inspection immediately. Warning High-Voltage When replacing the flash lamp, make sure the instrument is turned OFF and then unplugged from the power outlet. Otherwise, there may occur electrical shock. When replacing the fuse, make sure the instrument is turned OFF and un - plugged from the power outlet. If the fuse holder cover is removed with the instrument unplugged, there may occur electrical shock. This instrument is equipped with a storage capacitor for photography light. Replacing the flash lamp while this capacitor is still not yet fully discharged causes a danger of an electrical shock. Check that the discharge indicator LED is turned OFF before replacing the flash lamp. Obligatory Be sure to plug into the power outlet completely and securely. Otherwise there may cause a fire or electrical shock. Use a designated fuse only. Otherwise, the instrument may malfunction or a fire may break out. Make sure that the instrument is properly grounded to protect from bodily injury. Connect the plug into the three-wire grounding type outlet with ground wire. Otherwise, there may occur electrical shock. Prohibitory Do not place a container or cup containing liquid near the instrument. Spilled liquid entering into the instrument may cause electrical shock. If liquid should be spilled into the instrument, turn OFF the main power and then unplugged from the power outlet. Con - tact Kowa or your Kowa dealer for inspection. Do not load the power outlet or cable with excess of its rated capacity.  f the main power cable should share a power outlet with other devices and the rated capacity is exceeded, there may cause a fire or electrical shock. Do not insert any metal object into an air vent or opening of the instrument.  t may cause an instrument malfunctioning, fire or electrical shock. Disassembly prohibited Do not disassemble, modify or repair the instrument yourself. It may cause a fire, electrical shock, instrument malfunctioning or bodily injury. Refer all servicing to Kowa or your Kowa dealer. The product assembled by yourself will not be covered under warranty nor any other service. Caution Obligatory The power supply must be provided for the sole use of this instrument. Sharing a same power supply with other devices may cause malfunctioning. When operating the instrument, take good care so that the patient’s eye, nose or face does not come in contact with the instrument. When moving up or down the chin rest to adjust the height of the patient’s eyes, carefully ma - nipulate the instrument while checking the position of the patients’ head. A patient with the smaller head may get his or her head caught between the components. Handle the flash lamps and fuses made of glass with good care. A A A A A A B C A A A D D  Caution Prohibitory Do not pull the power supply cable when unplugging. Doing so may damage the cable and cause a fire or electrical shock. Be sure to hold the plug when unplugging. Do not plug or unplug the power supply cable with wet hand. Otherwise, there may occur electrical shock. Do not install the instrument at unstable location such as on a shaky base or a tilting surface. Doing so may cause the instrument to drop or fall over and result in a bodily injury. Caution High-temperature Do not replace the flash lamp immediately after turning the OFF the main power. You could be burned by the lamp heated to a high temperature. Wait for more than 10 minutes to cool the lamp down before replacing. Do not touch the flash lamp bulb with your bare hand. Otherwise, the lamp may reduce the light intensity and longevity. Do not increase the observation illumination light intensity more than required. Otherwise the eye may be injured. Do not increase the photography light intensity more than required. Otherwise the patient may experience pain and his or her eye may be injured. The air vent must not be obstructed. Obstructing the air vent may increase the internal temperature resulting in malfunctioning of the instrument or a fire. Do not insert any metal object into an air vent or opening of the instrument.  t may cause electrical shock and malfunctioning of the instrument. When operating this instrument, keep your fingers off the gap between the optical head base and the power supply or the chin rest support and the forehead rest support, or the gap under - neath the chin rest. Otherwise, the fingers may be pinched and injured. Instruct the patient not to place his or her fingers on the instrument. Do not wipe the outer surface of the instrument with solvents such as benzene, alcohol, or - ganic solvent, ether. Doing so may cause discoloration or degradation. Caution A : Keep your finger off the locations shown with an arrow “A” when operating the instrument. Otherwise, the fingers may be pinched and injured. Instruct the patient not to place his or her fingers on the instrument. Caution B : Take good care so that the patient’s eye, nose or face does not come in contact with the locations shown with an arrow “B” when operating the instrument. Caution C : When moving up or down the chin rest to adjust the height of the patient’s eyes, carefully manipulate the instrument while checking the position of the patients’ head. A patient with the smaller head may get his or her head caught between the components. Caution D : The air vent must not be obstructed. Obstructing the air vent may increase the internal temperature resulting in malfunction of the instrument or a fire. Caution D : Do not insert any metal object into an air vent or opening of the instrument.  t may cause electrical shock and malfunctioning of the instrument. Keep your finger off the spaces shown with an arrow. Otherwise you may be injured.  V Meanings of symbols Symbol for “Type B applied part”. Symbol for “Power ON”. Symbol for “Power OFF”. Symbol for “Caution”. Symbol for “Warning High-voltage”. Symbol for “Warning High-temperature”. Symbol for “MANUFACTURER” Symbol for “AUTHORISED REPRESENTAT  VE  N THE EUROPEAN COMMUNITY” V 1. Operating environment 1) Instrument should be operated only by qualified and trained personnel. 2) Handle the instrument with care, and do not apply strong shock to the instrument. 3) Avoid high temperature and humidity, direct sunlight, and dust when installing and storing the instrument. Strictly observe the following environmental conditions. Operating Transporting and storing Environmental temperature 10 to 35 °C -15 to +55 °C Relative humidity 30 to 90 % 10 to 95 % 4) Avoid condensation when using, transporting or storing the instrument. 5) Use the designated digital camera only since other camera may adversely affect the safety or performance of this instrument. 6)  nstall the instrument in a room where the lighting is 5 lux or less which you may barely manage to read a newspaper. 2. Precautions on electric system 1) When the instrument has not been used for a long period of time, inspect the items below.  nspect if the objective lens is free from soils.  nspect if intensity of the lamps appropriately adjustable. 2)  nstall the system in a location where there is little risk of the plug being pulled out while operating.  f the plug should be pulled out accidentally, be sure to turn OFF the main power before plugging the system back in. 3) Kowa is not liable for malfunctions and/or damages resulting from maintenance and/or repairs performed by the third party other than an agent authorized by Kowa. 4) Kowa is not liable for malfunctions and/or damages resulting from maintenance and/or repairs using parts other than repair parts specified by Kowa. 5) The input voltage should always be maintained within ± 10% of the rated voltage. 6) Do not turn ON the flash lamp and adjust photography light intensity at the same time. 7) Wait for approx. 10 seconds to stabilize the power unit after turning the power ON before using the switches on the operation panel. 8) Do not turn the main power ON and OFF in succession. Allow an interval of at least 10 seconds before turning the main power ON and OFF. 9) Be sure to turn OFF the main power before connecting an external device. 10) Do not touch the patient and connectors at the same time as it may adversely affect the safety. 11) Disinfect using alcohol the parts accessible by the patient. 12) The power supply must be provided for the sole use of this instrument. 3. Precautions when using a digital camera with this instrument 1) Carefully handle the objective lens as soiled or scratched part of the objective lens may be imaged as white spots. 2) Always cover this instrument and the digital camera when not in use in order to protect them. 3) Do not apply strong shock or force to the objective lens. 4) Set a dial or knob with clicking positions to its designated position. The dislocated diopter compensation knob may result in a photograph with a missing part or underexposure. 5) Securely install the digital camera. The digital camera installed insecurely may cause distortion of an image or misalignment of focus. The digital camera installed insecurely may fall off and become unusable. 6) Never disassemble or adjust this instrument or the digital camera by yourself as it uses precision parts which requires special tool for doing so. 4. Disposal precautions 1) LCD monitor of this instrument has a fluorescent lamp that contains mercury. When disposing this instrument, applicable federal, state, and local regulations must be observed. 2) When disposing, this instrument and/or its consumables is categorized as industrial waste; therefore, the disposal must be handled by licensed industrial waste disposal contractor. Operating precautions V  1. Precautions on use of medical electrical system 1) All components of this medical electrical system may be installed within a limited patient environment (a radius of 1.5 m around a patient) when all components are installed in accordance with the installation instructions using “Multi-tap with Isolation Transformer”, which is one of the system components. 2) As prerequisite for installing to this system, other components (a PC, printer, video capture printer, video monitor, or other devices) which do not comply with  EC60601-1 must be powered from Multi-tap with  solation Transformer. The electric power to these components supplied from an electric source other than Multi-tap with  solation Transformer (e.g., wall outlets) may cause increased enclosure leakage current or potential difference between protective grounds resulting in the injury to the patient or operator. Use Multi-tap with  solation Transformer only for supplying the power to the components other than the system components. 3) Any medical electrical equipment that connected to this system to compose a medical system must comply with  EC60601-1. 4) Any non-medical electrical equipment that is connected to this system to compose a medical system must comply with safety standards of IEC or ISO provisions applicable to such a non-medical electrical equipment. 5) Do not use any additional multi-tap or extension power cable other than those Kowa specified to this system. 6) Power supply to this system or “Multi-tap with Isolation Transformer” must be provided individually. (Do not route the power supply through other multi-tap to the system or “Multi-tap with Isolation Transformer”.) 7) The power cable for an electrical equipment that compose a medical system must have durability that meets  EC60245/  EC60227 or higher standards. 8) Assure that the power supply is turned OFF when connecting other device to the system. 9) Do not turn ON the power supply until all devices are completely connected. 10) Do not place or install the devices and the system components on the unstable or inclined table. 2. Precautions for use of “Multi-tap with Isolation Transformer” 1) Do not place “Multi-tap with Isolation Transformer” directly on the floor. Water droplets during room cleaning may enter the multi-tap resulting in the component failure. 2) The power supply cable to “Multi-tap with Isolation Transformer” must be connected to a power receptacle with a protective ground terminal equipotential to the protective ground of this instrument. 3) When using a multi-tap power receptacle with a protective ground terminal, read the instruction for use attached to the receptacle to familiarize yourself with the correct use before use. 3. Daily maintenance and cleaning 1) System components • Wipe the soiled outer surface with firmly squeezed dampened soft cloth. Use mild detergent to remove excessive soils. Do not use chemicals or solvents such as thinner and benzene. (As the LCD monitor screen cover easily gets scratched, lightly wipe it with soft cloth such as gauze.) • Refer to the instruction for use provided with each device for details of device maintenance and cleaning. 2) Power cables, connecting cables, and connectors • Visually inspect that all cables have no flaw or damage. • Visually verify that earth leads of all components and protective ground terminals are securely connected. • Disconnect the power cables from the power supply receptacles when you do not use the system for a long period of time. 3) Others • When you add a PC to the system for a filing purpose, captured images are stored in the HDD of the PC. Back up the data stored in the HDD regularly since HDDs may have a mechanical or electrical failure. Precautions: use of medical electrical system V  ● Combination of medical electrical equipment and non-medical electrical equipment IEC 60601-1-1 “Safety requirements for medical electrical systems” describes the components combination grouped into various clinical settings. The brief overview of  EC 60601-1-1 is shown below. Situation No. Medically used room Non-medically used room Feasible solution (See clause 19 in all situations)  nside the PAT  ENT ENV  RONMENT Outside the PAT  ENT ENV  RONMENT 1 1a  tems A and B in PAT  E N T E N V  R O N - MENT A  EC 60601 B  EC 60601 1b  tems A and B in PAT  E N T E N V  R O N - MENT A  EC 60601 B  EC XXXXX For B:Additional protective earth or separating transformer 1c  tem A powerd from specified power supply in item B in PAT  ENT ENV  RONMENT B  EC XXXXX For B:Additional protective earth or separating transformer 2 2a  tem A in PAT  ENT ENV  RONMENT and i t e m B i n m e d i c a l l y used room A  EC 60601 B  EC 60601 2b  tem A in PAT  ENT ENV  RONMENT and i t e m B i n m e d i c a l l y used room A  EC 60601 B  EC XXXXX For B:See 19.201 and its rationale 3 3a  tem A in PAT  ENT ENV  RONMENT and item B in non-medically used room A  EC 60601 B  EC 60601 or  EC XXXXX For B:See 19.201 and its rationale 3b  tem A in PAT  ENT ENV  RONMENT and item B in non-medically used room A  EC 60601 B  EC 60601 or  EC XXXXX For B:Additional protective earth or SEPARAT  ON DEV  CE KEY TO TABLE • Additional protective earth : If necessary, provide additional protective earthing , which is permanently connected(See also 58.201). NOTE Equipment modification may be required. • Separating transformer : If necessary, limit the ENCLOSURE LEAKAGE CURRENT, by using an additional separating transformer according to annex EEE. NOTE1 No equipment modification is required. NOTE2 A separating transformer is a transformer with one or more input winding(s) separated from the output winding(s) by at least basic insulation [  EC 60989] • SEPARATION DEVICE : If necessary, apply SEPARATION DEVICE. •  EC 60601 : MED  CAL ELECTR  CAL EQU  PMENT in compliance with  EC 60601. • IEC XXXXX : Non medical equipment in compliance with relevant IEC safety standards. Common protective earth Protective earth Protective earth with po- tential difference A  EC 60601 V  1. Only qualified personnel should operate this instrument. 2. The following items shall be considered when installing the instrument. 1)  nstall at a location away from water or accidental splashing. 2) Install at a location which will not be adversely affected by atmospheric pressure, temperature, humidity, ventilation, sunlight, dust, air containing salt, sulfur and other substances, and the like. 3) Take care to guard against tilt, vibration and strong impacts, for instance, during transportation. 4)  nstrument must not be installed at locations where chemicals are stored or gasses are generated. 5) Be careful with the radio frequencies, voltages and allowable amperes (power consumption) of the power supply. 6) Properly connect ground wires. 3. The following items shall be considered before using the instrument. 1) Make sure that instrument activates properly after checking switch contact, polarity, dial setting and meters and so forth. 2) Make sure that the instrument is properly grounded. 3) Make sure that all cords are properly connected and secured. 4) Use of other instruments and appliances on the same power circuit is liable to cause errors and incorrect flash output resulting in incorrect diagnosis or hazards. 5) External circuits and connectors that may come in direct contact with the patient must be checked frequently for signs of wear. 4. The following items shall be considered when using the instrument. 1) Be sure to minimize the time and quantity required for diagnosis and treatment. 2) Always assure that the instrument and patient are in good condition. 3) When an abnormality is found on the instrument, take proper measures, for instance, to stop the operation of the instrument while assuring the patient’s safety. 4) Do not allow the patient to 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 status following with a specified procedure. 2) Do not pull cords for removal because an excessive force is exerted on them. 3) The following shall be considered regarding storage location. • Store the instrument at locations free from splashes of water. • Store at a location which will not be adversely affected by atmospheric pressure, temperature, humidity, ventilation, sunlight, dust, air containing salt, sulfur and other substances, and the like. • Take care to guard against tilt, vibration and strong impacts, for instance, during transportation. •  nstrument must not be stored at locations where chemicals are stored or gasses are generated. 4) Clean and rearrange accessories, cords, and the like. 5) The instrument must be cleaned prior to use so that there will be no problem when using it again. 6. In case of a problem or malfunction, stop the operation and contact Kowa or your Kowa dealer for repair. 7. Instrument shall not be modified. 8. Maintenance 1) Periodically check the instrument and its components for any abnormality. 2) When using the instrument that has not been used for a while, it must be checked beforehand to assure that it is in normal condition and operates safely. 9. Be careful of the possibility that incorrect operation may be caused by strong electromagnetic waves. This instrument is examined based on EN 60601-1-2:2001. The purpose of this standard is to keep safety against the dangerous obstacle in typical medical facilities. When this instrument is influenced by other instrument, or when it affects other instrument or when there is such fear, please devise to move this instrument and other apparatus or to make the distance between those instrument. Moreover, if there is an unknown point, please consult our company, or an agency beforehand. Operational considerations for hospital grade electrical instrument (safety and accident prevention)  X Accessories Main body:1 digital camera:1 Power supply cable:1(2.5m) USB cable(Type A-B):1(3m) USB cable(Type A-Mini-B):1(3m) Chin rest paper:1 Chin rest paper retaining pin:2 Blower:1 Fuses:2 Dust cover:1 Instruction manual:1 Filing software:1 User’s guide:1 Installation manual:1 External fixation target:1 K9L-LE57 Numerical keypad:1 PC (filing software) :1 0 00 1 2 3 4 5 6 7 8 9 BS Enter Num Lock / OS : Windows XP/V  STA CPU : Celeron 1.0GHz Memory : 512Mbyte Display : XGA * Comparable or higher performance required Optional accessories  Contents Introduction .................................................. I Meanings of symbols ................................I V Operating precautions ............................... V Precautions: use of medical electrical system ........................................................ V I Operational considerations for hospital grade electrica l instrument (safety and accident prevention) .......VIII Accessories ...............................................I X Optional accessories ...................................  X Contents ......................................................   System description .................................... 2 1.1  ntended use ................................................ 2 1.2 System overview .......................................... 2 1.3 Features ....................................................... 2 1.4 Name and function of each component ....... 3 2 Installation ................................................... 9 2.1  nstalling the system..................................... 9 2.2  nstalling external device (optional PC) ...... 11 2.3 Connecting PC ........................................... 11 3 Saving captured images ..........................  2 3.1 Saving captured images in PC (optional device) ......................................... 12 3.2 Saving captured images in a SD card ........ 12 4 Basic operation.........................................  3 4.1 Moving component fixing screw ................. 13 4.2 Coarse motion: moving the optical head base for a long distance ...................................... 13 4.3 Fine motion: moving the optical head base for a short distance..................................... 13 4.4 Raising and lowering the optical component 13 4.5 Raising and lowering the chin rest ............. 13 5 Preparations for photography .................  4 5.1 Preparing the instrument ............................ 14 5.2 Preparations for patient’s eye examination 15 5.3 Selecting a photography mode .................. 15 6 Operational procedure in photography ..  6 6.1 Normal , SP, and stereo modes .................. 16 6.2 Precautions for continuous photography.... 22 6.3 Terminating photography............................ 22 7 Advanced photography ........................... 23 7.1 Mosaic mode photography ......................... 23 7.2 External fixation target ............................... 27 7.3 Diopter compensation range ...................... 27 8 Troubleshooting ....................................... 28 9 Menu operation ......................................... 3  9.1 Starting menu ............................................. 31 9.2 Objective lens cleaning lamp ..................... 31 9.3 Mosaic internal fixation target setting (Switching internal fixation target in mosaic mode photography )...................... 31 9.4 Other setting menu..................................... 33  0 Maintenance and inspection ................... 36 10.1 Daily maintenance...................................... 36 10.2 Daily inspection (by users) ......................... 36 10.3 Regular  nspection (by manufacturer) ........ 37 10.4 Cleaning the objective lens ........................ 37 10.5 Disinfection................................................. 38 10.6 Outer cleaning ............................................ 38 10.7 Replacing flash lamp .................................. 38 10.8 Fuse replacement ...................................... 40 10.9 Refilling and replacing consumables .......... 40 11 Specifications ........................................... 4  12 Technical information .............................. 42 12.1 Description of digital camera ...................... 42 12.2 Digital camera settings ............................... 43 12.3  maging conditions output .......................... 44  3 Electromagnetic compatibility (IEC60601-1-2) ........................................... 45 2 1.1 Intended use KOWA nonmyd WX is intended for use with retinal image capturing without mydriatic. The retinal image can be stored to an image filing drive through serial interface. 1.2 System overview This system is an instrument that enables retinal examination and retinal image capturing using infrared rays without re- quiring the patients to take any mydriatics and uses the normal or stereo light path to capture, record and display images. Also the designated filing software installed in a PC allows you to save, register or print the captured images. 1.3 Features 1) One-touch switching Normal, SP and stereo modes. 2) Field angles available are 45° with a round mask for normal mode and 34° (20° horizontal and 27° vertical directions) with a square mask for stereo mode. 3) Functions that support mosaic mode photography. 4) A high resolution digital camera is installed. 5) An intuitive operation panel allows you to diagnose effortlessly. 6) Anterior segment button enables one-touch switching between anterior segment alignment and retinal alignment screens easily. Modes and captured images Photography mode Normal mode SP (small pupil) mode Stereo mode Captured image Field angle 45° 45° k 34°(20°× 27°) k Some eyes may cause a fiare around their circumference. 1 System description 3 1.4 Name and function of each component 1 System description  f cannot in-focus by turning the focusing knob, pull the diopter compensation knob to make (-) or (+) compensa- tion until the focus point is found. Lamp cover Remove this cover to replace a flash lamp. Mosaic button Use this button to select ei- ther mosaic ON or OFF. Menu buttons Hold down the center button more than 2 seconds to access the menu mode for various set- tings of the instrument. You can also switch the internal fixation target position for the auto set- ting of internal fixation target position during mosaic mode photography. LCD monitor Black-and-white live image of the anterior segment and retinal appears for you to use for alignment and fo- cusing. Digital camera Stores and displays cap- tured images. Shutter button Pressing this button turns the flash on and takes a photo. Control lever U s e t h i s l eve r t o m ove around the optical head base. Turning the control lever moves the optical head base vertically. Blue / Brown selection switch Use this switch for setting the intensity suitable for blue or brown eye. Instrument label Operation panel (See the next page for de- tails) Diopter compensation knob 4 1.4 Name and function of each component Retinal observation light intensity control knob Used for adjusting light intensity during retinal observation. Exposure compensation knob Used for adjusting the photog- raphy light intensity when pho- tographing. Internal fixation target selection button Switch the internal fixation target position to posterior, optic disc, and center of mac - ula by pressing this button to go through these selections in normal mode. (  n stereo mode, pressing this button goes through optic disc, center of macula and then poste - rior.) The button turns OFF for posterior, illuminates for optic disc, and flushes for cen - ters of macula. This button turns OFF during mosaic mode photography and the inter - nal fixation target selection function becomes disabled. Anterior segment button Pressing this button switches the image shown on the LCD monitor between anterior segment and reti- nal. The button illuminates when the anterior segment is selected. Moving component fixing screw Tighten the screw when you need to fix the moving component. Stereo mode button Used for a stereo image with the field angle of 34° (20° hor - izontal and 27° vertical direc- tions). SP mode button Used for an image with the field angle of 45° for a small pupil diameter. Normal mode button Used for an image with the field angle of 45° for a normal pupil diameter. Chin rest raising and lowering buttons Used for raising or lowering the chin rest. The button illu- minates normally and flashes when it is in “SLEEP MODE”. Exposure compensation indicator  lluminates when exposure compensation knob is in any position other than “0” and turns OFF in “0”. Operation panel 5 Focusing knobs Knobs located on both sides of the optical head base , used for focusing. Objective lens Chin rest Used for sustaining the pa- tient’s chin position. Lamp cover screw Loosen this screws to re- move the lamp cover. Eye level mark Used for aligning the verti- cal position of the patient’s eye with this mark. Forehead rest Used for resting the patient’s forehead against it. Anterior segment observation lamp  nfrared LED lamp that illu- minates when the anterior segment is observed. Power supply unit (See the next page for details) 1 System Description Air vent Optical head base Main unit Optical component Power supply Moving component 6 1.4 Name and function of each component Power switch | :ON q :OFF Fuse holder Electrical supply inlet Air vent Image output terminal Used for connecting a PC to the instrument using a USB cable supplied. Imaging condition output terminal When you wish to acquire both captured images and imaging condition, use the USB cable supplied with this instrument to connect a PC to the instrument. Numerical keypad connecting terminal Connect a numerical keypad (optional accessory ) using this terminal when you define an internal fixation target position of your choice for mosaic mode photography. Cable clamps Used for holding cables to keep them from being disconnected. External fixation target connecting terminal A terminal which you connect an external fixation target (op - tional accessory: K9L-LE57). Power supply unit Overall system schematic  1 Anterior “ANTERIOR” indicates that the instrument is currently showing the anterior segment observation display. anterior segment observation : ANTER  OR retinal observation : none 2 Photography mode This indicates the current photography mode. Normal mode : NORMAL SP mode : SMALL PUP  L Stereo mode : STEREO 3 Mosaic mode photography ON : MOSA  C OFF : none 4 Pupil diameter aid for normal or stereo mode This aid appears when normal or stereo mode is selected. 5 Pupil diameter aid for SP mode aids these aids appear when SP mode is selected. 6 Anterior segment working dot position aids These aids appear during anterior segment observation for you to adjust the working dots. 7 Working dots The dots are shown optically for you to adjust the distance and position of a patient’s eye. 8 Blue eye This indicates the current Blue / Brown selection switch status. BLUE : Blue BROWN : none 9 Exposure compensation This indicates the current exposure compensation knob position. + 2/ + 1/0/ − 1/ − 2 0 Field angle This indicates the field angle currently selected. Normal or SP mode : 45˚ Stereo mode : 20˚ x 27˚ A Left or right eye This indicates which eye you are currently observing. Left eye : L Right eye : R B Diopter compensation This indicates the diopter compensation knob position. No corrective lens used ( − 12 m -1 (D) to +13 m -1 (D)) : none + compensation (+10 m -1 (D) to +35 m -1 (D)) : D+ − compensation ( − 32 m -1 (D) to − 10 m -1 (D)) : D − C Mosaic mode photography sequence or posi - tions This indicates the current photographing sequence num - bers or photographing positions in mosaic mode photog- raphy. AUTO : No. : 1a to 9a MANUAL : POS  T  ON : 1 to 9 D Mosaic fixation target switches They appear when the internal fixation target is set to auto during mosaic mode photography. u NEXT : Pressing the right button of the menu but- tons switches the current photographing position to the next position. t BACK : Pressing the left button of the menu but- tons switches the current photographing position to the previous position. Monitor screen indications Anterior segment observation display 1 System description 8 1.4 Name and function of each component E Fixation target position This indicates the fixation target position currently turned on. Normal, SP, and stereo modes Posterior : CENTRAL Optic disc : D  SC Center of macula : MACULA External fixation target : EXT Mosaic mode photography Internal fixation target : AUTO/MANUAL (this indicates the currently selected position selecting method) External fixation target : EXT F Completed mosaic mode photography This indicates the completed photographing sequence numbers or photographing positions in mosaic mode photography. AUTO :1a to 9a MANUAL :1 to 9 G Focus dots These dots are shown optically for you to use as refer- ence when focusing. The dots appear when no diopter compensation is selected. No dot appears when a + compensation or – compensa- tion is selected. H Retinal working dot position aids These aids appear during retinal observation for you to adjust the working dots. No aid appears in mosaic mode photography. I Working dots These dots are shown optically for you to adjust the dis- tance and position of a patient’s eye. No dot appears in mosaic mode photography. J Normal mode photographing range This indicates the photographing range in normal mode. K SP mode photographable range This aid appears when SP mode is selected.  t indicates an approximate range where a clear image is captured. L Stereo mode photographing range This aid appears when stereo mode is selected and indi- cates the photographing range in stereo mode. M Eye fixation direction and mosaic mode pho - tography position This indicates the guiding or alignment direction when the internal fixation target is used in mosaic mode photography. “ FIX TARGET ” indicates the direction to which you guide the patient’s eye fixation. Retinal observation display K9L33 496B K9L33 496C USB cable Trigger cable Power supply cable Synchronous cable All cables connected Connect the cable with “ ” mark facing to - wards the LCD monitor of the digital camera. k 9 2.1 Installing the system 1 Place the instrument on a powered optical table (optional accessory). observe the following precautions when moving the instrument. • Fasten the moving component fixing screw. • Put your hands under the power supply unit and lift the instrument as shown in the right figure. • Do not lift the instrument with holding any parts other than the above. • Check the place where you are going to set the instrument is flat with no obstacle that may catch your hand. • Be careful not to pinch your hand during installation. 2 Make sure that the power switch is in OFF (“ q ”) position. 3  nstall the digital camera in the camera mount. 2 Installation 5 Ensure that an eye piece cap is attached to the viewfinder of the digital camera. 4 Connect the synchronous, power supply, trigger and USB cables to the digital camera. k OFF  0 2.1  nstalling the system 6 Make sure that the power switch is in OFF position. Connect the power supply cable to the power supply cable connector. Connect the power supply cable plug to a power outlet. 7 Place the chin rest paper on the chin rest and fix the paper with the chin rest paper retaining pin. Use a sheet of chin rest paper per patient. Remove the top sheet of chin rest paper for the next patient. x Do not connect a digital camera other than that supplied with this instrument. x The digital camera is detachable: however, keep detaching/attaching the digital camera to the minimum in order to prevent debris or dust from entering into the instrument and the digital camera. x The digital camera needs to be disconnected from the instrument when the instrument is to be relocated or the in- side of the digital camera is to be cleaned. In such a case arises, contact Kowa or your Kowa dealer in advance for the correct procedures and precautions for detaching the digital camera. x The digital camera supplied with this instrument is set for the retinal camera photography. Do not change the setting. x Do not detach the eye-piece cap from the digital camera. x Do not disconnect the cables connected to the digital camera. Warning Obligatory Make sure that the instrument is properly grounded to prevent bodily injuries. Be sure to connect the plug into the three-wire grounding type outlet with ground wire. Otherwise, there may occur electrical shock. Caution Obligatory The power supply must be provided for the sole use of the reti- nal camera. Sharing the same power supply with other devices may cause malfunctioning.  2.2 Installing external device (optional PC) Install a PC by following the PC’s instruction manual and turn it on. Install the application software supplied with the PC. For details of installation, refer to “Installation manual (filing soft - ware)” . When you use a peripheral device and/or other device connected to the peripheral device, it must meet all applicable EN(  EC) standards. Data processing device must meet EN60601-1(  EC60601-1) or  EC60950. The system that combines such data processing device must meet EN60601-1-1(  EC60601-1-1). The system administrator who builds such system bears all responsibility to have the system comply with requirement of EN60601-1-1(IEC60601-1-1). Should you have any question, contact Kowa sales representative or dealership. 2.3 Connecting PC Connect the image output terminal (PC:  mage) of this instrument to an USB terminal of the PC using the USB cable (Type A-B) provided with the instrument. Connect the imaging condition output terminal (PC: Data) of this instrument to the USB port of the PC using the USB cable (Type A-Mini- B). k For information on how to connect the instrument to the PC as well as the details of how to use the software, see the attached “Installation manual (filing software)” and “User’s guide (filing software)” . 2  nstallation  2 3 Saving captured images Save captured images using the methods described in 3.1 or 3.2 below. 3.1 Saving captured images in PC (optional device) Install the supplied filing software into the PC (optional device). Use a USB cable supplied to connect a PC to the instrument. Captured images will be stored in the PC after it is con- nected to the instrument. About the PC For details of the specification of the required PC, see the attached “Installation manual (filing software)” and “User’s guide (filing software)”. x Do not use any USB cable other than the supplied cable. x Using other USB cable may inhibit normal operation. k For information on how to connect the PC to the instrument as well as details of how to use the software, see the attached “Installation manual (filing software)” and “User’s guide (filing software)” . 3.2 Saving captured images in a SD card  nsert a SD card into the digital camera. Captured images will be stored in the SD card. Captured images saved in a SD card Captured images saved in a SD card may be displayed on the LCD monitor of the digital camera. The images may be printed out connecting the digital camera to a printer. Contact Kowa or your Kowa dealer for details. x The photographed images are not saved in the SD card when the instrument is connected with the PC. loosen tighten  3 4.1 Moving component fixing screw Completely loosen the moving component fixing screw before starting any photography using this instrument. Completely tighten the moving component fixing screw before moving this instrument to other installation site. 4.2 Coarse motion: moving the optical head base for a long distance In order to move the optical head base for a slight distance, move the control lever lengthwise or crosswise while holding the lever tightly in upright position. 4.3 Fine motion: moving the optical head base for a short distance In order to move the optical head base for a very short distance, hold the control lever gently and tilt it lengthwise or crosswise. 4.4 Raising and lowering the optical component In order to move the optical component up and down, turn the rubber ring of the control lever. Turning the ring right moves the optical component up and turning left moves the optical component down. 4.5 Raising and lowering the chin rest In order to move the chin rest up, press chin rest raising button. In order to move the chin rest down, press chin rest lowering button. 4 Basic operation Retinal observation light intensity control knob Exposure compensation knob Exposure compensation indicator Diopter compensation knob  4 5.1 Preparing the instrument 1 Make sure that the moving component fixing screw is completely loosened. 2 Make sure that the instrument is correctly connected to the PC. Make sure that the PC is turned ON and the application software is started. 3 Remove objective lens cap. 4 Turn ON the power switch (place it in “ | ” position). 5 Make sure that retinal observation light intensity control knob, exposure compensation knob and diopter compensation knob are in their initial position. The initial positions for the knobs are as below Retinal observation light intensity control knob : Approx. 10-o’clock position Exposure compensation knob : 0 (The indicator under the knob turns OFF at the reference position. When it is at a position other than the reference position, the indica - tor illuminates.) Diopter compensation knob : Pressed position. (“D+” or “D-” does not appear on LCD monitor when it is in the initial position.) 5 Preparations for photography Eye level mark  5 5.2 Preparations for patient’s eye examination 1 Reduce room’s illumination as bright as to make letters on this manual barely readable so that patient’s pupil can naturally turn to the size of pupil diameter aid or greater. 2  nstruct the patient to take off his or her glasses or contact lenses. 3 Remove the top sheet of chin rest paper. 4 Move and keep optical component as close as possible to you and ask the patient to rest the chin on chin rest. 5 Adjust chin rest height until the patient’s eye level comes to the position of eye level mark. 6  nstruct the patient to rest his or her forehead on forehead rest. 7 Adjust height of the table which this instrument is installed on so that the patient can place his or her chin on chin rest with ease. 8 Adjust optical component height until it comes to the position of eye level mark. 5.3 Selecting a photography mode This instrument has “Normal mode”, “SP mode”, and “Stereo mode” for photographing. Press “Normal” button for normal photography, “SP” button for small pupil photography, or “Stereo” button for stereo mode. Upon activation of the instrument, “Normal mode” is selected. The photography mode currently selected is indicated on the upper left corner of LCD monitor. This instrument also has mosaic mode photography for imaging the center of macula and 8 points surrounding the macula. Press “Mosaic” button for mosaic mode photography. 5 Preparations for photography  6 6.1 Normal, SP, and stereo modes The chart shown blow describes the operation procedure in normal, SP, and stereo modes. Details of items shown in the chart are described on the following pages. Preparations for photography Turn ON the power switch ] Preparing this instrument ] Preparations for patient’s eye examination Anterior segment observation Selecting a photog- raphy mode 1) Selecting a photography mode Normal mode : NORMAL SP mode : SMALL PUP  L Stereo mode : STEREO Selecting fixation target 2) Selecting an internal fixation target Normal or SP mode : Posterior (CENTRAL) Stereo mode : Optic disc (D  SC) Anterior segment alignment 3) Make sure that the instrument is currently showing the an- terior segment observation display. 4) Guiding patient’s fixation : Ask the patient to look at the center of the fixation target. 5) Aligning: Move optical head base as close as possible to you. Move optical head base leftward/rightward and move main unit upward/downward to position the pupil image in the center of the LCD monitor. Move optical head base to place two working dots in the anterior segment working dot position aids “( )” shown on the center of LCD monitor. 6) Check the pupil diameter. Normal or stereo mode (Normal pupil photography): Pupil diameter: 4.0 mm or greater SP mode (Small pupil photography): Pupil diameter: 3.5 mm to 4.0 mm 7) Adjusting photography light intensity: Change the photography light intensity depending on pupil diameter. 8) Check that the eyelid is not intruding the pupil area. Switching to Retinal observation display 9) Press anterior segment button to switch to retinal observa- tion. Retinal observation Retinal alignment 10) Adjust the observation light intensity. 11) Guide the patient’s fixation. 12) Aligning: Move optical head base to place two working dots on the top of the left and right bars in the middle of LCD display. 13) Focusing: Turn focusing knob to have two focus dots on the display to form a single line. Photography 14) Photography: Press shutter button to photograph. 6 Operational procedure in photography  6.1.1 Selecting a photography mode Select a photography mode by pressing “Normal”, “SP”, or “Stereo” button. Check that the mode you have selected is shown on the upper left corner of LCD monitor. Normal mode SP mode Stereo mode 6.1.2 Selecting an internal fixation target Use internal fixation target selection button to select an internal fixation target that you use for retinal observation. Continuously pressing the button cycles through the targets as shown in the figure below. (Cyclic order of internal fixation targets) Posterior Optic disc Macula (CENTRAL) (D  SC) (MACULA) When the photography mode is switched, “CENTRAL” is selected for normal or SP mode while “DISC” is selected for stereo mode. The internal fixation target you have selected appears on the lower right corner of LCD monitor. (See the figures of normal, SP, and stereo modes shown in “6.1.1 Selecting a photography mode” .) 6 Operational procedure in photography  8 6.1 Normal, SP, and stereo modes 6.1.3 Checking anterior segment observation display Make sure that “ANTERIOR” is shown in the upper part of LCD monitor. Press anterior segment button when “ANTERIOR” is not shown. 6.1.4 Guiding patient’s fixation  nstruct the patient to look straight ahead. Perform the step described in “6.1.5 Alignment” . Ask the patient to look straight ahead at the green illuminating spot when the patient’s pupil becomes shown in the center of LCD monitor. When failed to complete the patient’s fixation by using the internal fixation target, use the external fixation target ( optional accessory: K9L-LE57). Refer to “7.2 external fixation target” for details of connecting and operating the external fixation target. 6.1.5 Aligning Pull the optical component as close as possible to you and move the optical head base leftward/rightward or upward/downward in order to capture the pupil at the center of the LCD monitor. Rotate focusing knob until the black line engraved on the knob faces upwards. After the pupil image is captured successfully, move the optical head base forward until two working dots come in two pairs of round brackets “( )”. Beginning of alignment Focusing knob position Alignment completed Exposure compensation knob  9 6.1.6 Checking pupil diameter Check the condition of dilation by comparing the patient’s pupil diameter against the pupil diameter aid. Change the photography light intensity as required depending on the mydriatic state. If the patient’s pupil diameter is smaller than that shown by the pupil diameter aid, press SP mode button to proceed to small pupil photography. Photography light intensity 0 +1 Insufficient for photography Normal mode Stereo mode Pupil diameter: 4 mm or greater SP mode Pupil diameter: 3.5 mm to 4 mm x In case of the above insufficient for photography, make the room darker, or take more time to get accustomed to darkness so that the pupil’s dilation can be facilitated. x It would be difficult to capture a clear image when the pupil diameter is insufficient. However it may not be appli - cable to some patients. 6.1.7 Adjusting photography light intensity Change the photography light intensity by the exposure compensation knob as needed depending on the condition of dilation. x The photography light intensity is automatically set to the standard level sufficient for each photographing pro - cedure. However, each patient’s mydriatic state and iris color may cause excessive or insufficient light intensity. When excessive or insufficient light intensity occurs, use exposure compensation knob to compensate the inten - sity. The LCD monitor shows the current light intensity setting as a guideline. Rotating exposure compensation knob to one step up or down changes 1/2 step of exposure value. 6 Operational procedure in photography anterior segment button 20 6.1 Normal, SP, and stereo modes 6.1.8 Checking eyelids and eyelashes The eyelids or eyelashes intruding the pupil area interferes photography. In such a case, • Instruct the patient to widely open his or her eyes, or • You or your assistant help the patient keep the eye wide open. OK NG OK 6.1.9 Switching from anterior segment observation to retinal observation After alignment of the anterior segment is completed, press anterior segment button to switch to retinal observation. When you want to go back to anterior segment observation, press the button again. “ANTERIOR” and the pupil diameter aid of the LCD monitor disappear during retinal observation. Anterior segment work - ing dot position aids “ ” changes to retinal working dot position aids “ ”, and the focus dots appears. Normal mode SP mode Stereo mode For stereo mode observation, move the photography target to the center of the LCD monitor. Retinal observation light intensity control knob Right eye Left eye Posterior Near center Optic disc Left Right Center of macula Center Working dot Retinal work- ing dot posi- tion aid Focus dots 2  6.1.10 Adjusting observation light intensity Adjust the image brightness by retinal observation light intensity control knob when the retinal image, focus dots, and working dots are not clearly shown. For details of LCD monitor brightness and contrast adjustment, refer to “9.4.6 MONITOR BRIGHTNESS / CONTRAST”. 6.1.11 Guiding patient’s fixation The fixation target position changes when anterior segment observation is switched to retinal observation.  n order for the patient to stare at the selected internal fixation target, guide the patient’s fixation to the internal fixation target by asking the patient to look at the green light. Patients would recognize the fixation target at the locations shown in the right table depending on whether the right or left eye is examined and which fixation target position is selected. 6.1.12 Aligning Move the optical head base slightly until the sizes of the two working dots become the smallest and the dots are aligned on the top of the left and right retinal working dot position aids “ ” in the LCD monitor as shown in the figure below. The focus of the two working dots may be fine tuned by moving the control lever forward/backward. 6.1.13 Focusing Turn focusing knob to have two focus dots “ ” on the display to form a single line. 6.1.14 Photography After alignment and focusing are completed, photograph by pressing shutter button. Pictures will be stored in the connected PC. For viewing and analyzing the pictures using a PC, refer to “Installation manual (filing software)”. 6 Operational procedure in photography 22 6.1 Normal, SP, and stereo modes / 6.2 Precaution for continuous photography / 6.3 Terminating photography 6.2 Precautions for continuous photography Please note that the LCD monitor automatically switches back to anterior segment observation. * 3 When you continue photographing, note the precautions described below. k 3 You may disable the anterior segment observation auto-return function by changing the setting. For details of the setting, refer to “9.4.4 EXTERNAL ALIGNMENT:NORMAL” and “9.4.5 EXTERNAL ALIGNMENT: MOSAIC” 6.2.1 Pupil diameter When you continuously photograph, the pupil is constricted due to the flash light in the previous photography. In such a case, wait for a while and make sure that the pupil diameter is sufficient for photography. 6.2.2 Photographing the other side of eye When continuously photographing the other side of the eye, pull optical head base toward you so that it will not contact the patient’s eye or nose and then move the digital camera toward the other side. x Do not increase the photography light intensity more than required. Otherwise the patient may experience pain and his or her eye may be injured. 6.3 Terminating photography • Turn OFF the power switch of this instrument (place it in “ q ” position), exit the filing software, and turn OFF the PC. Refer to “Instruction manual (filing software)” or the PC’s “Instruction manual” for how to terminate the PC. • Place the lens cap on the objective lens. • Move optical head base back to initial position where optical head base is positioned just above the power supply and fix it there by tightening the moving component fixing screw. • Place the dust cover over the instrument. 23 7.1 Mosaic mode photography Mosaic mode photography has its own internal fixation target selection and positioning different form that of Normal or SP mode.  n this section only these differences are described. Preparations for photography Turn ON the power switch k Preparing this instrument k Preparations for patient’s eye examination k Press mosaic button and check that “MOSAIC” appears on LCD monitor. Anterior segment observation Checking the selected photography mode 1) Checking the photography mode Normal mode : NORMAL SP mode : SMALL PUP  L Selecting a fixation target 2) Selecting an internal fixation target Anterior segment alignment 3) Make sure that the instrument is currently showing anterior segment observation display. 4) Guiding patient’s fixation : Ask the patient to look at the center of the fixation target. 5) Alignment: Move optical head base as close as possible to you. Move optical head base leftward/rightward and move optical component upward/downward to position the pupil image in the center of the LCD monitor. Move optical head base to place two working dots in the anterior segment working dot position aids “( )” shown on LCD monitor. 6) Check the pupil diameter: Normal mode (Normal pupil photography) Pupil diameter: 4.0 mm or greater SP mode (Small pupil photography): Pupil diameter: 3.5 mm to 4.0 mm 7) Adjusting the light intensity: Change the photography light intensity depending on pu- pil diameter. 8) Check that the eyelid is not intruding the pupil area. Switching to retinal observation 9) Press anterior segment button to switch to retinal observa- tion. Retinal observation Retinal alignment 10) Adjust the observation light intensity. 11) Guide the patient’s fixation. 12) Alignment: Position optical head base in the place where you can obtain the retinal image most clearly. 13) Focusing: Turn focusing knob to have two focus dots on the display to form a single line. Photography 14) Photography: Press shutter button to photograph. 7 Advanced photography 24 7.1.1 Selecting mosaic mode photography Press mosaic button (the button above “MENU” button). You can switch between Normal mode and SP mode during mosaic mode photography. 7.1.2 Selecting an internal fixation target Internal fixation target selection button becomes disabled during mosaic mode photography. Mosaic mode photography has two types of internal fixation target setting methods, “AUTO” and “ MANUAL ” settings. In “Auto mode setting”, one of the internal fixation targets is sequentially selected in the predefined order. In “Manual setting”, an internal fixation target is selected manually by pressing one of the keys corresponding to the pho - tographing parts of the eye. The default setting is “Auto mode setting”. For changing the setting, refer to “9.3 Mosaic internal fixation target setting (Switching internal fixation target in mosaic mode photography)”. L Switching the internal fixation target in mosaic mode photography – Use in auto mode Anterior segment observation display Retinal observation display The position of the anterior segment working dot position aids on anterior segment observation display changes depending on the photographing part of the eye. In auto setting, one internal fixation target is automatically switched to another after completing each photography and the corresponding photographing part of the eye is also changed consequently. When you want to photograph again because of poor photo quality, press the left key of the menu buttons. The internal fixation target that corresponds to the last photographing part illuminates. When you do not need to photograph the area currently selected, press the right side button of the menu button. This switches the current part to the next photographing part and the internal fixation target that correspond to the next photographing part illuminates. 1a to 9a shown on the bottom of LCD monitor indicate the mosaic mode photography sequence selected in menu mode. When a photograph is taken, the corresponding number becomes highlighted. Pressing shutter button by mistake while observing anterior segment does not allow the next photographing part to appear since an image capturing must be repeated again. For details of the mosaic mode photography sequence setting, refer to “9.3.2 Setting of auto mode” . 7.1 Mosaic mode photography 0 00 1 2 3 4 5 6 7 8 9 BS Enter Num Lock / Optional accessory 25 L Switching the internal fixation target in mosaic mode photography – Use in manual mode Anterior segment observation display Retinal observation display Select manual mode in order to select the photographing parts of your choice in mosaic mode photography. g For details of the setting, refer to “9.3 Mosaic internal fixation target setting (Switching internal fixation target in mosaic mode photography)” . Connect a numerical keypad (optional accessory) that allows you to select internal fixation target positions of your choice. Turn ON num lock of the connected numerical keypad. Keys of a numerical keypad are used to select internal fixation target positions in manual setting. Relationship between the keys and the internal fixation target positions is shown below. Keys of numerical keypad Right eye Left eye (Shaded keys are invalid.) The numbers from 1 to 9 that appear on the bottom of the display indicate photographing parts of the eye (and keys of numerical keypad). When a photograph is taken, the corresponding number becomes highlighted. The highlighting is cleared when the optical head base is moved to switch the eye to be examined to the other side of eye. 7 Advanced photography 26 7.1 Mosaic mode photography 7.1.3 Aligning and focusing In mosaic mode photography, align for anterior segment observation only, switch to retinal observation without changing the position of the instrument, check that the patient eye is correctly fixed, and photograph. However when you see an excessive flare during retinal observation, position the digital camera appropriately before photographing. For mosaic mode photography, the alignment position in anterior segment observation appears in different positions as shown in the figures below. Align appropriately so that the working dots fit within the anterior segment working dot posi - tion aids. “FIX TARGET” that indicates the eye fixation direction for you to direct a patient or the position of the internal fixation tar - get visible from a patient appears on the lower right of LCD monitor during retinal observation. Tell the patient the direction shown on the display and guide the patient’s fixation. Please note that some photographing parts may not clearly show the focus dots. In such a case, perform focusing using macula and photograph other photographing parts without re-focusing. However you may re-focus when you can see the focus dots clearly. k 4 2  7.2 External fixation target When failed to complete fixation of the patient’s eye using the internal fixation target, use the external fixation target (op - tional accessory: K9L-LE57) to enable the fixation using the other eye. 7.2.1 Installing the external fixation target 1 Aligning the groove on the external fixation target mount and the chin rest, tighten two mounting screws to lock the lamp. 2 Adhere attached cable clamps at two places shown in the figure and fix the cable with the cable clamps. 3 Insert the cable into the external fixation targ et connecting terminal. 7.2.2 Using the external fixation target The external fixation target illuminates by turning on the button installed on the cable.(When it is turned ON, the internal fixation target turns OFF.) “EXT” appears on the lower right corner of LCD monitor when the external fixation target is in use. 7.3 Diopter compensation range When clear focus can not be obtained by focusing, pull out diopter compensation knob. Pulling out diopter compensation knob to the first stop enables the minus diopter compensation (D-) while pulling out to the second stop enables the plus diopter compensation (D+). Slowly pull out the knob until it cricks when it comes into one of the diopter lens insert positions. When you stop pulling the knob before it cricks, you can not obtain a good image. The minus or plus diopter compensation is indicated on the upper right corner of LCD monitor.* 4 The focusing range of each compensation position is shown below. No diopter lens − 12 m -1 (D) to +13 m -1 (D) Plus diopter compensation + 10 m -1 (D) to +35 m -1 (D) Minus diopter compensation − 32 m -1 (D) to − 10 m -1 (D) Adjust the focus using the retinal image on the LCD monitor since focus dots do not appear when diopter compensation lens is in use. 1 2 3 7 Advanced photography 28 Examples of retinal photograph Possible cause Remedies Dark shadow or bright reflection appears at the top or bottom of the image. The instrument is positioned too high to the patient’s eye. Perform all alignment steps to obtain a clear retinal image with consistent brightness. De- pending on the patient’s eye fixation condi - tion, you may obtain a good image by locating working dots away from the dot position aid. The instrument is positioned too low to the patient’s eye. Dark shadow or bright reflection appears at the left or right of the image. The instrument is positioned too right or left to the patient’s eye. Perform all alignment steps to obtain a clear retinal image with consistent brightness. De- pending on the patient’s eye fixation condi - tion, you may obtain a good image by locating working dots away from the dot position aid. Diopter compensation knob is not in click. Check that diopter compensation knob is in the correct position by slowly moving the knob to see if it cricks. Peripheral area become whitened. The instrument is positioned too close to the patient’s eye. The instrument is positioned too far from the patient’s eye. Locate the digital camera to the position where working dots become smallest. When flares still persist, pull the digital camera a little or move the optical component to the patient. (Working dots may be fades a little.) The image is too dark. The pupil diameter is small. Turn exposure compensation knob to +1 or +2 position. If the patient’s pupil diameter equal to or smaller than that shown by the working dots, press SP mode button and photograph in SP mode. T h e i m a g e i s o u t o f f o c u s o r blurred. The patient has developed a cataract. Avoiding the area of white turbidity during alignment may allow you to obtain a good im- age. The corneal surface is dry. Ask the patient to blink before imaging. The image become whitened lo- cally. The objective lens is dirty. Clean the objective lens. Refer to “10. Maintenance and inspection” for details of the objective lens cleaning. The lower area become whitened. The eyelid or eyelashes intrude the imaging area. Ask the patient to open his/her eyes wide so that the eyelid or eyelashes do not intrude the area of the pupil, or you or your assistant help the patient keep the eye wide open. 8 Troubleshooting 29  rregularity Possible cause Remedies Focus dots do not appear. A diopter compensation lens is inserted. Adjust the focus using the retinal image since focus dots do not appear when a diopter com- pensation lens is in use. The flash lamp turns on but a black image or partially chipped image is obtained. The shutter speed of digital camera is not set to 1/25 sec. Set the shutter speed of digital camera to 1/25 sec. The flash lamp does not turn ON and no image is captured. The digital camera is not set to manual mode. Set the digital camera to manual mode. Trigger cable is not fully insert- ed. Fully insert the trigger cable to the end. Although image are successfully captured and shown on the LCD monitor of the digital camera, the monitor of the PC presents no im- age. The USB cable is not fully in- serted. Fully insert the USB cable to the end.  mages are captured without flash lamp turned on. The synchronous cable is not fully inserted. Fully insert the synchronous cable to the end. 8 Troubleshooting k Refer to “12 Technical information” . k Refer to “12 Technical information” . 30 8 Troubleshooting  rregularity Possible cause Remedies The error message below is dis- played on the LCD monitor. ERROR 1 : H  GHER VOLTAGE POWER OFF AND CALL SER - V  CE PERSON Charged voltage exceeded the limit. There could be a failure of an internal circuit. Please contact Kowa or your Kowa dealer. The error message below is dis- played on the LCD monitor. ERROR 2 : LOWER VOLTAGE POWER OFF AND CALL SER - V  CE PERSO N Charged voltage does not reach the lower limit. There could be a failure of an internal circuit. Please contact Kowa or your Kowa dealer. The error message below is dis- played on the LCD monitor. NOW COOL  NG PLEASE WA  T 120 SEC Cooling has been started since the recharge circuit tempera- ture exceeded the higher limit. This is not a malfunction. Wait for 120 sec- onds before you resume photography. Menu buttons 3  9 Menu operation 9.1 Starting menu Press down “MENU” button center of menu buttons for approx. 2 seconds to access menu mode. Use menu buttons “ G , H , F , and E ” in menu mode. 9.2 Objective lens cleaning lamp Objective lens cleaning lamp illuminates when you press “ F ” button to select “ON” while “LAMP FOR LENS CLEANING” is selected. Refer to “10 Maintenance and inspection” for details of the objective lens cleaning. 9.3 Mosaic internal fixation target setting (Switching internal fixation target in mosaic mode photography) Internal fixation target switching method is defined in this item. You can select either manual mode that requires a numerical keypad (optional accessory) for operation or “Auto mode” which automatically switches the fixation targets. You also set the illuminating order for auto mode and select the mirror symmetry of illuminating orders for the left and right eyes. 9.3.1 Settings for manual mode Press menu button while “MOSAIC INT-FIX” is selected to access the display shown in the right figure. Press menu button while “MANUAL” is highlighted to select “MANUAL” and return to menu item selection. 32 9.3.2 Settings of auto mode Press menu button while “AUTO” is highlighted to access “MOSAIC INT- FIX AUTO MODE SETTING”. Pressing menu button while “AUTO MODE SETTING” is highlighted makes one of the numbers shown under “PHOTO LOCATION ON THE RIGHT EYE” highlighted and allows you to start setting the photographing order. The current setting appears first when you access “AUTO MODE SETTING”. Use “ G , H , F , and E ” keys to move to the number of your choice. Select and highlight the number corresponding to the photographing part of the eye in the order you want to photograph and press menu button to set the illuminating order. When you terminate setting, highlight “SET” and press menu button. When you want to restart the setting, highlight “RESET” and press menu button. Also you can select the mirror symmetry of illuminating orders for the left and right eyes. When you want to apply the mirror symmetry, highlight “MIRROR SELECTION”, select “YES”, and press menu button. When you do not apply the mirror symmetry, select “NO” and press menu button. When you select “YES” for the “ MIRROR SELECTION”, illuminating orders are as shown below. Setting of illuminating orders Right eye Left eye 9.1 Starting menu / 9.2 Objective lens cleaning lamp 9.3 Mosaic internal fixation target setting (Switching internal fixation target in mosaic mode photography) 33 When you select “NO” for the “MIRROR SELECTION”, illuminating orders are as shown below. Setting of illuminating orders Right eye Left eye Select “SET” and press menu button in “MOSAIC INT-FIX AUTO MODE SETTING” to save the settings and return to menu item selection. When the power supply is turned OFF before pressing “SET”, the settings you have made will not be saved. 9.4 Other setting menu Press menu button while “OTHER SETTING” is highlighted to access the sub menu screen for other settings of this instrument. 9.4.1 POWER ON MODE 1 This item allows you to select the photography mode when the instrument is turned ON. Setting NORMAL : Normal mode (Factory setting) STEREO : Stereo mode How to set Press “ F ” or “ E ” button to switch the setting while “POWER ON MODE 1” is selected. Press menu button while the setting of your choice is highlighted to select the setting and return to menu item selection. 9 Menu operation 34 9.3 Mosaic internal fixation target setting (Switching internal fixation target in mosaic mode photography) 9.4 Other setting menu 9.4.2 POWER ON MODE 2 This item allows you to select the state of Blue/Brown selection switch when turning the instrument is turned ON. Setting BROWN : Brown eye (Factory setting) BLUE : Blue eye How to set Press “ F ” or “ E ” button to switch the setting while “POWER ON MODE 2” is selected. Select “END” and press menu button while the setting of your choice is highlighted to confirm the setting and return to menu item selection. 9.4.3 SLEEP MODE You can select “SLEEP MODE” (power saving mode) as the initial power mode when the instrument is turned ON. When this instrument is not operated for a certain period of time (approximately 10 minutes) it goes into “SLEEP MODE”. In “SLEEP MODE, the LCD” monitor and all lamps of observation illumination lamps except the chin rest raising and lowering button indicator lamp (the indicator lamp flashes during “SLEEP MODE”) turn OFF. When you activate any part of the instrument, it recovers from “SLEEP MODE”. Setting ON : SLEEP MODE (Factory setting) OFF : Normal mode How to set Press “ F ” or “ E ” of menu buttons to switch the setting while “SLEEP MODE” is selected. 9.4.4 EXTERNAL ALIGNMENT : NORMAL In normal mode, you can set whether or not the display automatically switches back to anterior segment observation after photography. Setting AUTO : The display automatically switches back to anterior segment. MANUAL : The display does not automatically switch back to anterior segment. How to set Press “ F ” or “ E ” button to switch the setting while “EXTERNAL ALIGNMENT : NORMAL” is selected. Select “END” and press menu button while the setting of your choice is highlighted to select the setting and return to menu item selection. 35 9 Menu operation 9.4.5 EXTERNAL ALIGNMENT : MOSAIC In mosaic mode photography, you can set whether or not the display automatically switches back to anterior segment observation after photography. Setting AUTO : The display automatically switches back to anterior segment. MANUAL : The display does not automatically switch back to anterior segment. How to set Press “ F ” or “ E ” button to switch the setting while “EXTERNAL ALIGNMENT : MOSAIC” is selected. Select “END” and press menu button while the setting of your choice is highlighted to select the setting and return to menu item selection. 9.4.6 MONITOR BRIGHTNESS / CONTRAST Press menu button while “MONITOR BRIGHTNESS” or “MONITOR CONTRAST” is selected to display an observation image. Use the image to set the LCD monitor screen brightness or contrast. Press “ G ” or “ H ” key to increase or decrease the brightness or contrast. While looking at the observation image on the LCD monitor, select an appropriate brightness or contrast and press menu button. 9.4.7 Exiting a menu To exit menu mode, select “END” in any of the menu screen. 36 This instrument is a precision instrument and daily maintenance and inspection would affect the imaging results. Please read the following information carefully in order to use this product correctly and safely. 10.1 Daily maintenance 1. What to do after use: Turn the power switch OFF Place the lens cap on the objective lens Place the dust cover over the instrument 2. Check that no dust, debris, finger print, or body fluid is found on the objective lens. 3. Determine that the objective lens is clean before you start using the instrument the first time each day. Dirty objective lens is readily identified under the objective lens cleaning lamp (see “9.2 objective lens cleaning lamp” ). When the objective lens is dirty, follow the steps described in “10.4 Cleaning the objective lens” to clean it. 4. Condensation may occur on the objective lens when the instrument is moved into an environment where there is temperature difference. When condensation occurs, wait until it disappears before use. 5. When condensation occurs repeatedly, lenses may get moldy. When such a case has occurred to you, contact Kowa or your Kowa dealer. 6. Disconnect the power supply cable when the instrument is not used for an extended period of time. 10.2 Daily inspection (by users) Inspect this instrument in accordance with “KOWA nonmyd WX daily inspection table”. When an anomaly found during the inspection may not be solved using any of the maintenance methods described in this instruction manual, contact Kowa or your Kowa dealer. KOWA nonmyd WX daily inspection table  nspection Procedure Acceptability criteria Power cable Visually verify that the cable has no flaw or damage. No flaw or damage should be found. Objective lens See “10.4 Cleaning the objective lens”. No dust, debris, fingerprint, teardrop must be found. Exterior Visually verify that the exterior has no flaw, crack, deformation or rust. Exterior components must have no flaw, crack, deformation or rust. Plates and labels Visually verify that the  D plate and la- bels is readily readable and not contami- nated. Rating plates and labels must be read- able. Shutter button and flash lamp Make the instrument ready for photogra- phy. Hold your hand in front of the objec- tive lens. Push the shutter button and visually verify that the flash light emitted through the objective lens illuminates the hand (do not look into the objective lens). Pressing the shutter button must acti- vate the flash lamp to emit the light. 10 Maintenance and inspection 3  10.3 Regular inspection (by manufacturer) In order to use this instrument safely over its useful life, we recommend you to have it inspected annually. Contact Kowa or your Kowa dealer for details and cost of inspections. 1. External components and their installation 2. Optical components 3. Operations and functions of components 4. Photograph quality inspection using standard model eye (0D) 5. Photography light intensity 10.4 Cleaning the objective lens You can not obtain a good image if the objective lens is contaminated with fingerprints, etc. Clean the lens as described below: 1 Turn ON power switch. 2 In order to identify soils on the objective lens clearly, reduce room’s luminance, and turn ON the objective lens cleaning lamp. (Refer to “ 9.2 Objective lens cleaning lamp” for details of how to turn ON the objective lens cleaning lamp.) 3 Using high-pressure air, blow off debris or dust. 4 When the air does not clean the objective lens , moisten soft cloth or cleaning paper with cleaning solution made from ethyl alcohol and ether (1:1) and clean the lens starting from its center in a circular motion. x Tips for lens cleaning Do not reuse soft cloth or cleaning paper but use new soft cloth or cleaning paper moistened with cleaning solu- tion to obtain the best results. k Cleaning the lens without removing soils or applying a strong force when wiping may scratch the lens surface. k Do not use chamois leather, silicon cloth, or eyeglass cleaner paper, etc. k Carefully store and handle the flammable and combustible cleaning solution. 5 If any soil is left out after cleaning with the cleaning solution, gently wipe off the soiled area with a cotton swab soaked with a little amount of water. After this cleaning step, wipe the lens using the cleaning solution described above. Should you have stubborn soil that cannot be removed by the steps above, contact Kowa or your Kowa dealer. 6 Turn OFF the objective lens cleaning lamp after the lens cleaning is completed. 10 Maintenance and inspection 38 10.3 Regular inspection (by manufacturer) / 10.4 Cleaning the objective lens 10.5 Disinfection / 10.6 Outer cleaning / 10.7 Replacing flash lamp 10.5 Disinfection Wipe the forehead rest with rubbing alcohol as soon as a patient completes the examination. Also wipe the chin rest with rubbing alcohol when no chin rest paper is used. 10.6 Outer cleaning Caution Prohibitory Do not wipe the outer surface of the instrument with solvents such as benzene, alcohol, thinner, ether. Such substances may cause the surface to be discolored or deteriorated. x Wipe the outer surface with soft cloth, from which water (used to moisten the cloth) was firmly squeezed off. x Lightly wipe the LCD monitor screen cover with soft cloth such as gauze because it is easily damaged. Wipe off the obstinate dirt with soft cloth, from which water or lukewarm water used to dilute a small amount of neutral detergent was squeezed off. 10.7 Replacing flash lamp Warning Unplug Warning High-Voltage W h e n r e p l a c i n g t h e f l a s h l a m p , m a k e sure the instrument is turned OFF and un - plugged from the power outlet. Otherwise, there may occur electrical shock. Warning Unplug Warning High-Voltage This instrument is equipped with a storage capacitor for photography light. Replacing the flash lamp while this capacitor is still not yet fully discharged causes a danger of an electric shock. Check that the discharge indicator LED is turned OFF before replacing the flash lamp. Caution Prohibitory Caution High-temperature Do not replace the flash lamp immediately af- ter turning the instrument OFF. You could be burned by a lamp heated to a high temperature. Allow 10 minutes to cool it down before re- placing. Caution Prohibitory Do not touch the flash lamp bulb with your bare hands. Other - wise, the lamp may reduce the light intensity and longevity. Discharge indicator LED 39 1 Rotate control lever to move optical head to the uppermost location. 2 Turn OFF the power switch and unplugged from the power outlet. 3 Loosen lamp cover screws with a coin or a screwdriver and then remove lamp cover. Make sure that the flash lamp has been cooled down before proceeding to the next step. 4 Check that the discharge indicator LED shown in the figure is completely turned OFF. It normally turns OFF completely within three minutes after the instrument is turned OFF. If it does not turn OFF even after above period of time, contact Kowa or your Kowa dealer as it may carry a risk of failure. In such a case, never touch the instrument. k Discharge indicator LED illuminates only when it discharges after the instrument is turned OFF. 5 After the discharge indicator LED is turned OFF and the flash lamp is fully cooled down (about 10 minutes after the power is turned OFF), unscrew two screws by a screwdriver and remove the flash lamp socket. 6 Hold the lamp and its socket in your hand, remove the flash lamp, and install a new lamp in the socket. k When replacing the flash lamp, pull straight out and push straight in the bulb towards the direction of electrode pin. Do not twist the flash lamp when fitting or removing it. k Fully insert the flash lamp to the end of the socket. k Do not touch the flash lamp bulb. 7 Tighten two screws of the flash lamp socket with a driver. Pay attention not to pinch the cables around the instrument when installing the flash lamp socket. 8 Place lamp cover and tighten lamp cover screws with a coin or a driver. k When installing the lamp cover, make sure that the cable of the illumination lamp socket is snugly housed within the external sheath. 9 Connect the power supply cable plug to the power outlet and turn ON the power switch. 0 Turn ON the instrument and perform test photography. 10 Maintenance and inspection 40 10.7 Replacing flash lamp / 10.8 Fuse replacement / 10.9 Refilling and replacing consumables 10.8 Fuse replacement Warning Unplug Warning High-Voltage When replacing the fuse, make sure the instru - ment is turned OFF and unplugged from the power outlet.  f the fuse holder cover is removed with the in- strument unplugged, there may occur electrical shock. Warning Obligatory Use a designated fuse only. Otherwise, the instrument may malfunction or a fire may break out. 1 Turn OFF the power switch and pull the plug from the power outlet. 2 Make sure that the instrument is turned OFF and wait for discharge at least 5 minutes for safety. 3 Press down the fuse holder with a screwdriver and turn the fuse holder to the direction of the arrow (counterclockwise) for removal. 4 Pull the old fuse and replace it with a new one. Make sure that the fuse type and rating are correct. 5 Press down the fuse holder with a screwdriver and turn the fuse holder to the opposite direction of the arrow (clockwise) and install it in place. 6 Connect the power cable plug to an power outlet. 10.9 Refilling and replacing consumables Order spare parts by purchase order numbers listed below to Kowa or your Kowa dealer. Part name Purchase order number Flash lamp K9L39FU Fuses 21802.5M (T2.5AL250V) Chin rest paper K9L-TB45#102 Chin rest paper retaining pin K9L-TB45#101 Dust cover AFT2#179 4  Shooting mode Normal / SP / Stereo (electrically switched) Stereoscopic photography method Simultaneous stereo photography Stereo photography parallax 7.4° (at the 0 diopter eye) Field angle Normal mode : 45° SP mode : 45° Stereo mode : 34° (20° horizontal and 27° vertical directions) * Some eyes may cause a flare around their circumference. Tolerance of pixel pitch on fundus (  SO 10940) Normal image : S * ( 9 μm ± 7 %) L * (4.5 μm ± 7 %) Stereo image : S * (5.5 μm ± 7 %) L * (2.7 μm ± 7 %) Working distance 30 mm Minimum pupil size Normal mode : 4.0 mm SP mode : 3.5 mm Stereo mode : 4.0 mm Compensation range of examined eye Without compensation : − 12 m -1 (D) to +13 m -1 (D) Compensation + : +10 m -1 (D) to +35 m -1 (D) Compensation − : −32 m -1 (D) to − 10 m -1 (D) Focusing Split luminous bars coincidence Working distance adjustment 2 luminous dots indication type Camera Specific Nikon digital SLR camera Monitor 5.7-inch LCD monitor Light source Observation : Near-infrared LED Photography : Xenon flash lamp Internal fixation target Central, Disc, Macula,mosaic 8 positions Optical head base adjustment range Movable 40mm forward/backward Movable 98mm leftward/rightward Movable 27mm vertically (electric) Chin rest adjustment range Movable 55mm (electric)  nterfaces  mage output : USB (B type)  maging conditions output : USB (mini-B type ) Numerical keypad input : USB (A type) Power supplies Input : AC100-240V, 50/60Hz Power consumption : 150VA Dimensions 310(W)x504(D)x548(H)mm Weight 21kg / 46lbs (excluding the attached digital SLR camera) *S/L :  mage size set on the digital camera Compliance standard • EN 60601-1:1990 +A1:1993+A2:1995 • EN 60601-1-2:2001+A1:2006 Classification of equipment based on EN 60601-1 • According to the type of protection against electric shock (Class device) • According to the degree of protection against electric shock (Type B applied part) • According to the type of protection against ingress of water as detailed in the current edition of  EC60529. (  PX0) • According to the degree of safety of application in the presence of a flammable anaesthetic mixture with air or with oxygen or nitrous oxide. (Equipment not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide) • According to the mode of operation. (continuous operation) Complied EC Directive Medical Device Detective 93/42/EEC : WEEE Directive 2002/96/EC 11 Specifications AF M 42 12 Technical information 12.1 Description of digital camera Focus-mode selector Set the mode to “M” Focus selector lock Set the selector to “L” Mode dial Set the mode to “M” Multi selector Move up Move to the lower hierarchy, Confirm Move down Move to the upper hierarchy, Chancel Menu button SHOOT  NG MENU Set picture control Image quality  mage size White balance  SO sensitivity settings Color space Long exp. NR High  SO NR Standard Sharpening Contrast Brightness Saturation Hue CUSTOM SETT  NG MENU SETUP MENU Menu hierarchy Main command dial Set the shutter speed to 1 /25 . Release mode button Set the mode to “ S ” 43 12.2 digital camera setting Ensure that the digital camera settings are correctly configured. Dial setting Custom menu Menu items Setting Menu items Setting Mode dial M No memory card? LOCK Focus-mode selector M Focus selector lock L Set-up menu Shutter speed * 5 1 /25 Menu items Setting k 5 Use Main command dial to set the shutter speed. Language English Photography menu Release mode Menu items Setting Menu items Setting Set picture control Standard Release mode Single frame Sharpening +4 Contrast 0 Brightness 0 Saturation −1 k 6 You may change photo quality mode an d  m- age size at your discretion.  mage quality : FINE, NORMAL, BASIC Image size : L, M, S Hue +2 Image quality* 6 FINE  mage size* 6 S (2144×1424) White balance color temperature setting 5560(A4,M1)  SO sensitivity settings 400 Color space sRGB Long exp. NR OFF High  SO NR OFF x Do not turn OFF the digital camera when communication is ongoing between the digital camera and the PC. x The items not shown above may use their default settings. 12 Technical  nformation 44 12.2 digital camera setting / 12.3  maging condition output 12.3 Imaging conditions output This instrument outputs the imaging conditions from  maging condition output terminal.  f you want to read the imaging conditions using application software other than that provided with the instrument, refer to the specifications below: For this purpose, you need to install FTDI “Direct (D2XX) driver Ver 2.04.06 or later” into your PC to which this instru- ment is connected. Communication related specifications Baud rate : 38400 Data length : 8 bit Parity : even Stop bit : 1 bit Flow control : none Output data Output item Description Example Model name Fixed value K9L57  nstrument number 10-digit number 16174 ]]]]] Photography mode NORMAL/SP/STEREO STEREO Light intensity selector knob position -2/-1/0/+1/+2 0 Blue or brown eye BLUE/BROWN BLUE Diopter compensation 0/D+/D- 0 Left or right eye L/R R Fixation target 1 to 7/EXT 1 to 7 Internal fixation target illuminat - ing position C (Posterior), N (optic disc), M (Macula), U (Up) UR (Upper right), UL (Upper left), R (Right), L (Left), D (Down), LR (Lower right), LL (Lower left) C Observation screen ANTE/FUNDS FUNDS k A linefeed code is inserted every output of an item. 45 13 Electromagnetic compatibility (IEC60601-1-2) This instrument is a medical electrical instrument. Medical electrical instruments are requireed special attention to the electromagnetic compatibility (EMC). The following section describes the EMC and precautions regarding this instrument. When installing or using this instrument, read the description carefully and follow the directions described. (The EMC of this instrument was tested based on  EC60601-1-2.) 1. Please note that portable- or mobile-type radio frequency communication devices (RF communications instrument) may adversely affect this instrument resulting in malfunctioning. 2. The electromagnetic compatibility (EMC) of this instrument was tested with the options and accessories shown below. Since using an option or accessory other than those specified may cause malfunctioning of this instrument due to interferences of other device or cause malfunctioning of other device, use only the options or accessories specified for this instrument. ● 100V power supply cable : KP300VCTF3X1.25SQKS16A, 2.5 m ● 120V power supply cable : KP320SJT18X3KS31, 2.5 m ● 230V power supply cable : KP-4819Y KS-31A, 2.5 m ● PC : CE Marking, VCCI, and FCC approved PC ● USB cable (Type A-B) : 3 m ● USB cable (Type A-Mini- B) : 3 m ● Numerical keypad ● External fixation target (K9L-LE57) 3. This instrument is not designed such that it can be used adjacent to other instrument or placing one on top of another. Therefore, do not apply such use. Nevertheless, if such use is inevitable, it is necessary to monitor constantly if the instrument is functioning normally after such use has been adopted. 4. Accessories and options used with this instrument are tested for EMC when combined with instrument below. Since using with an instrument other than that specified may cause malfunctioning of this instrument due to interferences of other devices or cause malfunctioning of other devices, do not use any instrument other than specified below. Option 1: CE Marking, VCCI, and FCC approved PC 5. We specified the functions listed in the table blow as the basic performance of this instrument to determine EMC of this instrument. Functions Essential performance Light-emitting functions Light-emitting function  llumination light intensity setting and switching  llumination light intensity settings Charge function  nstrument operation functions Optical head vertical movement Chin rest vertical movement Anterior segment/retinal switching Normal mode switching SP mode switching Stereo mode switching Anterior segment illumination Retinal observation light intensity adjustment W.D. ON/OFF F.D. ON/OFF Photography functions  mage signal output LCD monitor display functions LCD monitor screen display (OSD) LCD monitor screen display (through image) 46 13 Electromagnetic compatibility (  EC60601-1-2) [Compliance verification and guidance] Guidance and manufacturer’s declaration - electromagnetic emissions KOWA nonmyd WX is intended for use in the electromagnetic environment specified below. The customer or the user of KOWA nonmyd WX should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment - guidance RF emissions C  SPR 11 Group 1 KOWA nonmyd WX uses RF energy only for its internal function. There - fore, its RF emissions are very low and are not likely to cause any interfer - ence in nearby electronic instrument. RF emissions C  SPR 11 Class B KOWA nonmyd WX is acceptable in all types of facilities without any limita- tion to the electrical supply network connected to KOWA nonmyd WX. Harmonic emissions  EC 61000-3-2 Class B Voltage fluctuations/ flicker emissions  EC 61000-3-3 Complies Guidance and manufacturer’s declaration - electromagnetic immunity KOWA nonmyd WX is intended for use in the electromagnetic environment specified below. The customer or the user of tKOWA nonmyd WX should assure that it is used in such an environment.  mmunity test  EC60601 test level Compliance level Electromagnetic environment - guidance Electrostatic discharge(ESD)  EC61000-4-2 ±6kV contact ±8kV air ±6kV contact ±8kV air Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Electrical fast transient/burst  EC61000-4-4 ±2kV for power supply lines ±1kV for input/output lines ±2kV for power supply lines ±1kV for input/output lines Mains power quality should be that of a typical commercial or hospital environment. Surge  EC61000-4-5 ±1kV differential mode ±2kV common mode ±1kV differential mode ±2kV common mode Mains power quality should be that of a typical commercial or hospital environment. Voltage dips, short interruptions and voltage variations on power supply input lines  EC61000-4-11 <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 cycle 70% UT (30% dip in UT) for 25 cycle <5% UT (>95% dip in UT) for 5 sec Mains power quality should be that of a typical commercial or hospital environment.  f the user of KOWA nonmyd WX requires continued opera - tion during power mains interruptions, it is rec - ommended that KOWA nonmyd WX be powered from an uninterruptible power supply. Power frequency (50/60Hz) magnetic field  EC61000-4-8 3 A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. N OTE UT is the a.c. mains voltage prior to application of the test level. 4  13 Electromagnetic compatibility (  EC60601-1-2) Guidance and manufacturer’s declaration - electromagnetic immunity KOWA nonmyd WX is intended for use in the electromagnetic environment specified below. The customer or the user of KOWA nonmyd WX should assure that it is used in such an environment.  mmunity test  EC 60601 test level Compliance level Electromagnetic environment– guidance Conducted RF  EC 61000-4-6 Radiated RF  EC 61000-4-3 3 Vrms 150 kHz to 80 MHz 3 V/m 80 MHz to 2.5 GHz 3 V 3 V/m Portable and mobile RF communications instru - ment should be used no closer to any part of KOWA nonmyd WX, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance d=1.2 P d=1.2 P 80 MHz to 800 MHz d=2.3 P 800 MHz to 2.5 GHz where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recom- mended separation 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.  nterference may occur in the vicinity of instru- ment marked with the following symbol: Recommended separation distances between portable and mobile RF communications instrument and KOWA nonmyd WX KOWA nonmyd WX is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The cus - tomer or the user of KOWA nonmyd WX can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications instrument (transmitters) and KOWA nonmyd WX as recommended below, according to the maximum output power of the communications instrument. Rated maximum 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 NOTE 1 At 80MHz and 800MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the KOWA nonmyd WX is used exceeds the applicable RF compliance level above, the KOWA nonmyd WX should be observed to verify normal operation. f abnormal performance is observed, additional measures may be necessary, such as reconfiguring or relocating the KOWA nonmyd WX b Over the frequency range 150kHz to 80MHz, field strengths should be less than 3 V/m. P 0.01 0.12 0.12 0.23 0.1 0.37 0.37 0.74 1 1.2 1.2 2.3 10 3.7 3.7 7.4 100 12 12 23 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (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 transmitter manufacturer. NOTE 1 80MHz and 800MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. For EU market. © 2010 Kowa Company, Ltd. All rights reserved. K9L57 V1.0 E 10050 7 Printed in Japan  mmermannstrasse 43B 40210 Duesseldorf, F.R. Germany Phone: 49(211) 1793540 Facsimile: 49(211) 161952 Hamamatsu Factory 3-1, Shinmiyakoda 1-chome , Kita-ku, Hamamatsu city, Shizuoka Pref., 431-2103 Japan 4-14, Nihonbashi-honcho 3-chome, Chuo-ku, Tokyo 103-8433 Japan Phone: 81(3) 3279-7639 Facsimile: 81(3) 3279-7541 (World Sales Headquarters)