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Kowa nonmyd WX 3D manuel d'utilisation

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Table des matières du manuel d’utilisation

  • Page 1

    INSTRUCTION MANUAL 2D/3D Non-mydriatic Retinal Camera Kowa KOW A nonmyd WX EU[...]

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    [...]

  • Page 3

    I Accept our congratulations on your purchase of KOW A nonmyd WX. KOW A nonmyd WX is a Non-mydriatic retinal camera for mono and stereo retinal photography . This manual provides a description of the operation procedures of KOW A nonmyd WX and important precautions to be observed during its use. Please read this manual carefully to assure that the [...]

  • Page 4

    II W arning 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 re. Con - tact Kowa or your Kowa dealer for inspection immediately . W ar[...]

  • Page 5

    A A A A A A B C A A A D D III Caution Prohibitory Do not pull the power supply cable when unplugging. Doing so may damage the cable and cause a re 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[...]

  • Page 6

    IV Meanings of symbols Symbol for “T ype B applied part”. Symbol for “Power ON”. Symbol for “Power OFF”. Symbol for “Caution”. Symbol for “W arning High-voltage”. Symbol for “W arning High-temperatu re”. Symbol for “MANUF ACTURER” Symbol for “AUTHORISED REPRESENT A TIVE IN THE EUROPEAN COMMUNITY”[...]

  • Page 7

    V 1. Operating environment 1) Instrument should be operated only by qualied 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 conditi[...]

  • Page 8

    VI 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 a ll components are installed in ac cordance with the installation in structions using “Multi-tap with Isolation T ransformer”, which is one of [...]

  • Page 9

    VII ● 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 IEC 60601-1-1 is shown below . Situation No. Medically used room Non-medically used room Fe[...]

  • Page 10

    VIII 1. Only qualied personnel should operate this instrument. 2. The following items shall be considered when installing the instrument. 1) Install 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[...]

  • Page 11

    IX Accessories Main body:1 digital camera:1 Power supply cable:1(2.5m) USB cable(T ype A-B):1(3m) USB cable(T ype 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 xation target:1 K9L-LE57 Numerical keypad:1 PC ([...]

  • Page 12

    1 Contents Introduction .................................................. I Meanings of symbols ................................ I V Operating precautions ............................... V Precautions: use of medical electrical system ........................................................ V I Operational considerations for hospital grade electri[...]

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    2 1.1 Intended use KOW A nonmyd WX is intended for use with retinal image capturing without mydriatic. The retinal image can be stored to an image ling 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 [...]

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    3 1.4 Name and function of each component 1 System description If c an not i n- fo cu s b y tur ni ng t h e f o c u s i n g k n o b, p u l l t h e d i o p t er c o m p e n s a t i o n k n o b to m ake (- ) or ( + ) c om pen sa- t i o n u n t i l t h e f o c u s p o i n t i s foun d. Lamp cover Remove this cover to repl ace a as h lam p. Mosaic b[...]

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    4 1.4 Name and function of each component Retinal observation light intensity control knob Use d for adju stin g lig ht inten sit y duri ng ret inal o bse r vatio n. Exposure compensation knob Use d for adjus tin g th e ph otog - rap hy li ght in tens it y wh en p ho - togr aph ing. Internal xation target selection button Switch the internal [...]

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    5 Focusing knobs K n o b s l o c a t e d o n b o t h s i d e s o f t h e optical head base , use d for foc usi ng. Objective lens Chin rest Us ed f or s us t ai ni ng t he p a- tien t’s ch in po sit ion. Lamp cover screw L o o s e n t h i s s c r e w s t o r e - move the l amp c over . Eye level mark Us e d fo r al i g n in g t h e ve r ti - c al[...]

  • Page 17

    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 Use d for c onne ct ing a P C to the in str ument u sin g a USB ca bl e sup pli ed. Imaging condition output terminal Whe n you w ish t o a[...]

  • Page 18

    7 1 Anterior “ANTERIOR” indicates that the instrument is currently showing the anterior segment observation display . anterior segment observation : ANTERIOR retinal observation : none 2 Photography mode This indicates the current photography mode. Normal mode : NORMAL SP mode : SMALL PUPIL Stereo mode : STEREO 3 Mosaic mode photography ON : MO[...]

  • Page 19

    8 1.4 Name and function of each component E Fixation target position This indi cates the xation targ et positi on currently turned on. Normal, SP , and stereo modes Posterior : CENTRAL Optic disc : DISC Center of macula : MACULA External xation target : EXT Mosaic mode photography Internal xation target : AUTO/MANUAL (this indicates the cu[...]

  • Page 20

    K9L33 496B 注意 感電 警 告 ランプ、フラッシュ ランプ、 蛍光灯を交換する時は必ず 電源スイッチをOFF にし て行ってください。 K9L33 496C 注意 高温 注 意 ランプ、フラッ シュランプ、 蛍光灯の使用直後は熱くなって いますので充分冷ましてから 交換してくださ?[...]

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    OFF 10 2.1 Installing 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 x the paper with the chin rest paper retaining pin. Use a sheet of chin rest paper per [...]

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    1 1 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 (ling soft - ware)” . When you use a peripheral device and/or other device connected to the peripheral devic[...]

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    12 3 Saving captured images Save captured images using the methods described in 3.1 or 3.2 below . 3.1 Sa vi ng cap tu red im ag es in P C ( o pti on al de v ice ) Install the supplied ling 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-[...]

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    loosen tighten 13 4.1 Moving component xing 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 C oar se mo tio n : mo vi ng the op ti cal he ad bas e fo r a l ong d is ta[...]

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    Retinal observation light intensity control knob Exposure compensation knob Exposure compensation indicator Diopter compensation knob 14 5.1 Preparing the instrument 1 Make sure that the moving component xing scre w is completely loosened. 2 Make sure that the instrument is correctly connected to the PC. Make sure that the PC is turned ON and th[...]

  • Page 26

    Eye level mark 15 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 Instruct the patient to take off his or her glasses or contact lenses. 3 Remove the top sheet of [...]

  • Page 27

    16 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 T urn ON the power switch ] Preparing this instrument ] Preparations for patient’ s eye examination Anterior segment ob[...]

  • Page 28

    17 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 xation target Use internal xation target selection button to select an [...]

  • Page 29

    18 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 xation Instruct the patient to look straight ahead. Perform the step described in “6.1.5 Al[...]

  • Page 30

    Exposure compensation knob 19 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 [...]

  • Page 31

    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 • Y ou or your assistant help the patient keep the eye wide open. OK NG OK 6.1.9 Switching from ant[...]

  • Page 32

    R e t i n a l o b s e r v a t i o n l i g h t i n t e n s i t y co ntrol k no b Right eye Left eye Posterior Near center Optic disc Left Right Center of macula Center Working dot Retin al wor k- ing d ot p osi - tio n ai d Focus dots 21 6.1.10 Adjusting observation light intensity Adjust the image brightness by retinal observation light intensity c[...]

  • Page 33

    22 6.1 Normal, SP , and stereo modes / 6.2 Precaution for continuous photography / 6.3 T erminating 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 Y ou may disable the [...]

  • Page 34

    23 7.1 Mosaic mode photography Mosaic mode photography has its own internal xation target selection and positioning dif ferent form that of Normal or SP mode. In this section only these differences are described. Preparations for photography T urn ON the power switch k Preparing this instrument k Preparations for patient’s eye examination k Pr[...]

  • Page 35

    24 7.1.1 Selecting mosaic mode photography Press mosaic button (the button above “MENU” button). Y ou can swi tc h be twe en N or ma l mo de an d SP mo de d ur ing mos ai c mo de photography . 7.1.2 Selecting an internal xation target Internal xation target selection button becomes disabled during mosaic mode photography . Mosaic mode pho[...]

  • Page 36

    0 00 1 2 3 4 5 6 7 8 9 BS Enter Num Lock / Optional accessory 25 L Switching the internal xation target in mosaic mode photography – Use in manual mode Anterior segment observation display Retinal observation display S el ec t ma nua l mo de i n or de r to s el ect the ph oto gr ap hin g pa rt s of y ou r choice in mosaic mode photography . g [...]

  • Page 37

    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 xed, and photograph. However when you see an excessive are during retinal observation, posi[...]

  • Page 38

    k 4 27 7.2 External xation target When failed to complete xation of the patient’s eye using the internal xation target, use the external xation target (op - tional accessory: K9L-LE57) to enable the xation using the other eye. 7.2.1 Installing the external xation target 1 Aligning the groove on the external xation target moun[...]

  • Page 39

    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. Perf orm al l alig nmen t step s to ob tain a c lear ret ina l im age wit h co nsi ste nt b rig htn ess . De - pending on the patient’s eye fixation con[...]

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    29 Irregularity 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 ash lamp turns on but a black image or partially chipped image is obtained. The shutter speed of digital camera is no[...]

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    30 8 T roubleshooting Irregularity Possible cause Remedies The error message below is dis- played on the LCD monitor . ERROR 1 : HIGHER VOL T AGE P OWER OF F AND CALL SER - VICE 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[...]

  • Page 42

    Menu buttons 31 9 Menu operation 9.1 Starting menu Pre ss down “MEN U” butto n cen ter of menu butt ons for app rox. 2 secon ds to acces s men u mod e. Use menu butt ons “ G , H , F , a nd E ” i n men u mod e. 9.2 Objective lens cleaning lamp Objective lens cleaning lamp illuminates when you press “ F ” b u t t o n t o select “ON” w[...]

  • Page 43

    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 LOCA TION ON THE RIGHT EYE” highlighted and allows you to start setting the photographing order . The c[...]

  • Page 44

    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”[...]

  • Page 45

    34 9.3 Mosaic internal xation target setting (Switching internal xation 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 P ress [...]

  • Page 46

    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 AUT O : T h e display automatically switches back to anterior segment. MANUAL : The display does not automatically switch back to anterior s[...]

  • Page 47

    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: T urn the power switch OFF Place the lens cap on the objective lens Place the dust cov[...]

  • Page 48

    37 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 q[...]

  • Page 49

    38 10.3 Regular inspection (by manufacturer) / 10.4 Cleaning the objective lens 10.5 Disinfection / 10.6 Outer cleaning / 10.7 Replacing ash 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 cl[...]

  • Page 50

    Dis cha rge ind ica tor LED 39 1 Rotate control lever to move optical head to the uppermost location. 2 T urn 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 ash lamp has been cooled down before proceeding to the next step. 4 Check t[...]

  • Page 51

    40 10.7 Replacing ash lamp / 10.8 Fuse replacement / 10.9 Relling and replacing consumables 10.8 Fuse replacement W arning Unplug W arning High-V oltage When replacing the fuse, make sure the instru - ment is turned OFF and unplugged from the power outlet. If the fuse holder cover is removed with the in- strument unplugged, there may occur el[...]

  • Page 52

    41 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 ey es may caus e a are ar ound their circumfe[...]

  • Page 53

    AF M 42 12 T echnical information 12.1 Description of digital camera Focus-mode selector Set the mode to “M” Focus selector lock Set the s ele cto r to “L ” Mode dial Set the m od e to “M” Multi selector Move up Move to th e lower hier arc hy , Con rm Move dow n Move to the upper hierarc hy , Chancel Menu button SHOOTING MENU Set pic[...]

  • Page 54

    43 12.2 digital camera setting Ensure that the digital camera settings are correctly congured. 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. Lang[...]

  • Page 55

    44 12.2 digital camera setting / 12.3 Imaging condition output 12.3 Imaging conditions output This instrument outputs the imaging conditions from Imaging condition output terminal. If you want to read the imaging conditions using application software other than that provided with the instrument, refer to the specications below: For this purpose,[...]

  • Page 56

    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 descri[...]

  • Page 57

    46 13 Electromagnetic compatibility (IEC60601-1-2) [Compliance verication and guidance] Guidance and manufacturer ’s declaration - electromagnetic emissions KOW A nonmyd WX is intended for use in the electromagnetic environment specied below . The customer or the user of KOW A nonmyd WX should assure that it is used in such an environment. [...]

  • Page 58

    47 13 Electromagnetic compatibility (IEC60601-1-2) Guidance and manufacturer ’s declaration - electromagnetic immunity KOW A nonmyd WX is intended for use in the electromagnetic environment specied below . The customer or the user of KOW A nonmyd WX should assure that it is used in such an environment. Immunity test IEC 60601 test level Compli[...]

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    For EU market.[...]

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    © 2010 Kowa Company , Ltd. All rights reserved. K9L57 V1.0 E 10050 7 Printed in Japan Immermannstrasse 43B 40210 Duesseldorf, F .R. Germany Phone: 49(21 1) 1793540 Facsimile: 49(21 1) 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, T okyo 103-84[...]