KowaメーカーKOWA VX-20の使用説明書/サービス説明書
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INSTRUCTION MANUAL RETINAL CAMERA Kowa KOW A VX-20 US.
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I Accept our congratulations on your purchase of KOW A VX-20. KOW A VX-20 is a retinal camera which is capable of mydriatic and non-mydriatic photography . This manual provides a description of the operation procedures of KOW A VX-20 and important precautions to be observed during its use.
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.
III 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.
IV Caution for ngers location Caution Keep your ngers off the location shown with the arrows in the illus- tration when operating this instrument. Otherwise, the ngers may be pinched and injured. Instruct the patient not to place his or her ngers on the instrument.
V Meanings of symbols Symbol for “Caution”. Symbol for “W arning High-voltage”. Symbol for “Caution High-tempera- ture”. Symbol for “Power ON”.
VI 1. Operating environment 1) Instrument should be operated only by qualied 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.
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 .
VIII 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.
IX 1. Only qualied 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.
X Components and supplies Main unit Optical Component Power supply Accessories USB cable 1(A─mini-B type×2):1(2.3m) Objective lens cap holder: 1 Illumination lamp: 1 Instruction manual: 1 Setup man.
XI Optional accessories Internal xation target: 1 K9L-PE56 Grips: 2 K9L-GR56 Forehead rest: 1 K9L-HR56 Exciter & Barrier lter set for F AF: 1 K9L-IF56K Bar code reader: 1(1.
XII MENU Introduction ............................................................................................. I Operational considerations for safety .................................................................................... I Meanings of symbols .
XIII 3.4 Mydriatic Fluorescein angiography procedures ....................................................... 19 3.5 Viewer mode functions and procedures .................................................................. 23 4 Advanced operation ......
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1 1.1 Indication for use The KOW A VX-20 is intended for taking picture of retinal images with mydriatic or without mydriatic. 1.2 System overview This instrument is a retinal camera, capable of captu.
2 1 System description 1.4 Name and function of each component Main unit External xation target It fr eely move s patient ’s xati on. Optical viewnder (eyepiece) Th is i s an o pti ca l vi .
3 1 System description O bs er v at io n l ig ht i n te ns it y c on - trol knob It is a k nob to adju st th e inte nsit y of th e illu minati on dur ing obse rvat ion. Flash i ntensity compensat ion knob It is a k nob to adj ust the inte nsit y of the illu minati on when p hotogr aphin g.
4 1 System description Lamp cover Internal xation target socket W .D. switch It tu rns on /of f t he il lumi nati ng dot s for detec ting the align ment p osit ion of th e retinal c amer a.
5 1 System description Fuse holder Power switch It is a switch t o turn o n/of f the powe r of thi s instr ument . I: ON , : OFF Cable clamps U s e d f o r h o l d i n g c a b l e s t o k e e p the m from b eing dis conn ected Compact ash memory card insert slot Ac cepts a c ompa ct ash m emor y ca rd [suppli ed].
6 1 System description 1.5 LCD monitor indications In this section, the information and buttons displayed on the LCD monitor are described. 1.5.1 Capture mode screen 1 Timer By pre ssing th e ti mer b utto n in th e Flu oresc enc e ang iogr a- phy mo de, it w ill be di splayed o n the LCD m onito r and st art co unting.
NEXT BACK RERI PHERAL VIEWER EXT CENTRAL MACULA PERI PHERAL DISC FIXTION BLUE BROWN VIEWER FIXA TION STILL VIEW USER1 USER2 USER3 7 1 System description 1.5.2 Viewer mode screen s d f g h j k a a Setting button It is a b utton t o set vario us set tings.
8 2 Preparation 2.1 Assembly and installation 1 Following the assembly manual provided separately , assemble the power supply unit and the optical component. Assembly must be done by qualied personnel who have received assembly training pro- vided by Kowa or a Kowa dealer .
9 2 Preparation 2.2.2 Removing a compact ash memory card Slowly press the ejector button to eject the compact flash memory card. Then, hold and slowly pull out the card. Notice ¿ Do not attempt to remove the compact ash memory card without using the ejector button.
10 2 Preparation 2.3.2 VK connection In order to use this instrument in the VK connection setting, Kowa VK series (optional device) and the USB cable 1 are required. For information on the installation and use of the VK series, refer to the installation and the user manuals supplied with the VK series.
1 1 2 Preparation Notice ¿ T urning OFF the instrument without following the above procedures may result in a loss of data or damage to the instrument. With an exception of emergency situations, follow the above procedures to turn OFF the instrument.
12 3 Basic operation 3.1 How to use the control lever The control lever is used to move the optical component of the retinal camera lengthwise or crosswise, and upward/downward. When roughly divided, there are three ways to use it: • Coarse motion: moves the optical component lengthwise or crosswise broadly .
13 3 Basic usage 3.2 Non-mydriatic photography/ autouorescence photography procedures This section describes the basic operation procedures for non-mydriatic and autouorescence photography . The operation of buttons e xplained in the procedures is based on the factory default.
14 3 Basic usage 5 Select a xation target. Press the “xation target selection button” on the LCD monitor to select a xation target and the position of the patient's eye xation. 6 Compensate the diopter . As needed, press the “diopter compensation buttons” on the right side panel and use the diopter compensation lens.
15 3 Basic usage 9 Adjust the focus. T urn the “focusing knob” to adjust the focus. When you turn the focusing knob, the focus dots on the LCD monitor move left and right. T urn the focusing knob so that the upper and lower focus dots come to form a straight line.
16 3 Basic usage 3.3 Mydriatic color/ Red Free photography procedures This section describes the basic operation procedures for mydriatic color photography and Red Free pho- tography . Notice ¿ In some cases, the use of mydriatics may aggravate patient's medical conditions or cause some pa- tients to go into shock.
17 3 Basic usage 4 Adjust the ash intensity . The ash intensity is automatically set according to the photography mode. If it is necessary to adjust ash intensity , you may do so with the ash intensity compensation knob. 5 Select a eld angle.
18 3 Basic usage 9 Guide the patient's xation. Use the external xation target to guide the patient's xation position until the part you want to photograph becomes visible through the op- tical viewnder (eyepiece). ¿ Position the external xation target where the patient can x the vi- sion with the eye not examined.
19 3 Basic usage 3.4 Mydriatic Fluorescein angiography procedures This section describes the basic operation procedures for mydriatic Fluorescein angiography . Notice ¿ In some cases, the use of mydriatics may aggravate patient's medical conditions or cause some pa- tients to go into shock.
20 3 Basic usage 4 Adjust the ash intensity . The ash intensity is automatically set according to the photography mode. If it is necessary to adjust ash intensity , you may do so with the ash intensity compensation knob. 5 Select a eld angle.
21 3 Basic usage 9 Guide the patient's xation. Use the external xation target to guide the patient's visual xation until the part you want to photograph becomes visible through the op- tical viewnder (eyepiece). ¿ Position the external xation target where the patient can x the vi- sion with the eye not examined.
22 3 Basic usage Photograph the image. Press the “Shutter button” to activate the ash and photograph the image. When the connection conguration in “Stand-alone” or “Network con- nection”, images are displayed in the preview window immediately after they are photographed.
23 3 Basic usage 3.5 V iewer mode functions and procedures This section describes various functions of the viewer mode. Y ou may go to the viewer mode by pressing the “VIEWER button” on the LCD monitor while in the capture mode. Y ou cannot take photograph in the viewer mode.
24 3 Basic usage 3.5.1 Entering an ID and switching between IDs ─ Entering an ID ─ This function is enabled while the connection conguration is in “Stand-alone” or “Network connection.” Enter a new ID. Numbers 0 through 9 and the hyphen (“ ─ ”) may be used for ID.
25 3 Basic usage ─ Switching to another ID ─ This function is enabled while the connection conguration is “Stand-alone.” Y ou may switch from the current ID to an existing ID under which you want to save or view . Procedure 1 Press the “Input ID button” to go to the ID screen.
26 3 Basic usage 3.5.3 Multiple image display This function is enabled while the connection conguration is “Stand-alone.” Y ou may view the images saved under an ID, up to four images at a time.
27 3 Basic usage ─ Selected image display ─ While on the four-image display , press any of the images to view . “Select ” is indicated on the corner of the selected images ( is a number of your selection). After making your selection, press the “MUL T button” again to view only the selected images.
28 3 Basic usage 3.5.4 Deleting photographed images This function is enabled while the connection conguration is “Stand-alone.” Y ou may delete images while viewing them. ─ While on the single image display ─ When you press the “TRASH button” while the image you want to delete is displayed, an alarm message appears.
29 3 Basic usage 3.5.5 Printing photographed images This function is enabled while the connection conguration is “Stand-alone.” Y ou may print photographed images that are saved.
30 4 Advanced operation 4.1 T ilt and panning This instrument has the tilt and panning mechanism, which is used to photograph more surrounding eld in mydriatic color photography and uorescence angiography . 4.1.1 Tilt 1 Rotate the tilt lock knob to the left as you face directly to the tilt lock knob to release the lock.
31 4 Other functions 4.2 Small pupil photography This section describes how to photograph patients with a small pupil diameter . While this method allows you to photograph patients with a small pupil diameter , there are such disadvan- tages as smaller eld angles or easier occurrence of a are.
32 4 Other functions The LCD monitor shows the approximate pupil diameter that may be photographed. The outer circle of the double circles shown in the illustrations below is the approximate pupil diameter that may be sufciently photographed in the current diameter setting.
33 4 Other functions 4.3 LCD Monitoring This section describes how to perform alignment on the LCD monitor without using the optical viewnder (eyepiece) during mydriatic color photography , Red Free photography , uorescence angiography , and mydri- atic monitoring in F AF .
34 4 Other functions 4.4 Switching xation target This instrument automatically switches to an appropriate xation target and the position of patient’s eye xa- tion when the photography modes are changed.
35 4 Other functions ─ About “Peripheral” photography ─ This section describes how to switch the light position of the xation target and how to guide the patient's xation when “Peripheral” photography is selected. Go to [SettingsInt ernal Fixation T arget] to specify a photography sequence for a par t to be photographed.
36 4 Other functions ─ About the internal xation target (optional accessory) ─ Use the internal xation target (optional accessory) if you want to record the patient's xation position in the photographed images.
37 4 Other functions 4.5 Additional adjustment of the ash intensity(+5 or more, - 5 or less) Y o u ma y us e thi s fu nctio n to c ompe nsate t he f lash in - tensity beyond the compensation range allowed with the ash intensity compensation knob.
38 4 Other functions 4.8 Power saving function When the buttons on the operation panel and LCD monitor are not operated for a certain period of time (ap- proximately 10 minutes), the instrument goes into the power saving mode.
39 5.1 Main 5.1.1 Monitor brightness In this tab, you may adjust the brightness of the LCD monitor ,from level 1 through 10 with an increment of one. 5.1.2 Date In this tab, you may set the date format and delimiter as well as adjust the date and time.
40 5 Setting 5.1.4 Operation sound In this tab, you may enable or disable the operation sound used in functions such as timer and alarm. 5.1.5 System connection conguration In this tab, you may set the system connection conguration of this instrument.
41 5 Setting 5.2 Capture 5.2.1 Flash intensity Incr ements of ash in tensity : Y o u may set 0. 3EV o r 0.5E V to ca librate t he in crement of incr ease/de- crease of the ash intensity compensation knob.
42 5 Setting 5.2.3 Image quality/color This function is enabled while the connection conguration is in “Stand-alone” or “Network connection.” ¿ In “VK connection”, the image quality and color settings for the photographed images are congured in the VK series, which allows more detailed settings.
43 5 Setting 5.4 Advanced functions 5.4.1 Internal xation target In this tab, you may congure the internal xation target settings regarding “Peripheral”. Y ou may set the lighting sequence of the xation targets to be lit and whether the sequence for the right eye should be mirrored for the left eye.
44 5 Setting Items to set Camera sensitivity : photography sensitivity of the camera. X1: Standard, X2: two fold, X4: four fold As the setting is changed from X1 to X4, photography with low ash intensity be- comes possible, but the image quality is compromised.
45 5 Setting 5.4.4 Blue/Brown Y ou may select whether “Blue” or “Brown” is enabled at the time of start-up. 5.4.5 F AF observation The F AF observation mode, which is usually used for the LCD monitoring of non-mydriatic state, also al- lows observation of mydriatic state through the optical viewnder (eyepiece).
46 5 Setting 5.5 Maintenance 5.5.1 Making a backup copy of compact ash memory card Y ou may make a backup copy of the data saved in the compact ash memory card. Notice ¿ When more than two backup media are connected, the one connected to the instrument rst pre- cedes the other .
47 5 Setting 5.5.4 Setting a password Y ou may set so that a password is required when making a backup copy or formatting a compact ash memory card. Select “Password” tab.5.5.4_1 Press “Set a password” button. The window shown in 5.5.4_2 appears.
48 6 T roubleshooting T hi s s e ct i on d e s cr i be s t r ou b le s h oo t in g p ro c e du r es t o s o lv e p r ob l em s y o u m a y e n co u nt e r . L o ok f o r t h e applicable symptom from th ose shown in the following list and apply the applicable remedy .
49 6 T roubleshooting Abnormal performance of the instrument Symptom What to check · State of equipment Remedy The button different from the pressed button reacts during LCD monitor operation. It is out of calibration. Calibration must be performed. Y ou see nothing when you look into the viewnder .
50 6 T roubleshooting Abnormality in captured images Images show white shadow spots at the same places. Is there dust on the objective lens? Clean the objective lens. See 7.3.1 . Is the objective lens contaminated by tears etc.? Clean the objective lens.
51 6 T roubleshooting Error message Error code Description Remedy EPC01 Failure of the camera for image capturing T urn off the power and stop using. EPC02 Failure of the camera for observation T urn off the power and stop using. EPC03 Failure of the CF memory card Replace the CF memory card.
52 The retinal camera is a precision instrument and daily maintenance and inspection may affect the imaging results. Please read this section carefully in order to use this instrument correctly and safely .
53 7 Maintenance and inspection 7.2 Daily inspection Inspect this instrument in accordance with “KOW A VX-20 daily inspection table” below . KOW A VX-20 daily inspection table Inspection items Procedure Acceptability criteria Plates and labels Visually verify that plates and la- bels are readily readable and not contaminated.
54 7 Maintenance and inspection Objective lens (Perform the following after in - specting the observation illumina- tion lamp.) T urn the observation light intensity control knob to maximum, and visually verify the objective lens from oblique angle.
55 7 Maintenance and inspection 7.3.2 Cleaning and disinfection of the parts where patients contact the instrument (the forehead base, the chin rest, and the grip (optional accessory)) Wipe the forehe.
56 7 Maintenance and inspection 5) Hold the shade of the illumination lamp, pull the at spring which xes the lamp cover , and remove the lamp with the lamp socket from the lamp cover . 6) Hold the shade of the illumination lamp and pull it straight and slowly from the lamp socket 7) Attach a new illumination lamp to the lamp socket.
57 7 Maintenance and inspection 7.4.2 Replacement of the lamp for photography 1) T urn off the power switch and unplug the power plug from the electrical outlet. W ait for about 30 minutes and cool the lamp unit. 2) Remove the internal black lamp cover when replacing the illumina - tion lamp.
58 7 Maintenance and inspection Caution Prohibitory W arning High-temperature Do not replace the ash lamp tube or observation light bulb immediately after use. When replacing the ash tube or observation light bulb, be sure to turn OFF the main power switch and unplug it from the power outlet, and wait for 30 minutes or more.
59 7 Maintenance and inspection 7.5 Regular inspection In order to use this instrument safely over its useful life, we recommend you to have it inspected annually . 1. Records of each setting 2. External components and their installation 3. Optical components 4.
60 8 Specications Field angle Mydriatic: 50º/30º Non- mydriatic: 45º/27º Working distance 39mm (between the patient’ s eye and the front of the ob- jective lens) Diopter compensation range of.
61 9 T echnical information 9.1 Folder structure and data format of the compact ash memory card Image les (JPEG) and photography condition les (XML) are generated and saved in each of ID folders. File name [ID]_[YYMMDD]_[HHMMSS]_KOW A_[Photography type]_[Photographed eye]_[T imer elapsed time].
62 9 T echnical information The structure of the photography condition les is as shown below . <?xml version=“1.0” encoding=“UTF-8”?> <?xml-stylesheet type=“text/xsl” href=“Fundus_Stylesheet.xsl”?> <Ophthalmology xmlns:xsi=“http://www .
63 9 T echnical information 9.2 Number of photographs taken using the supplied memory card The number of photographs you may take using the supplied 2-GB memory card depends on the photogra- phy mode as well as size and compression rate that are set according to 5.
64 10 Light Hazard (ISO 15004-2) “Caution – The light emitted from this instrument is potentially hazardous. The longer the duration of exposure, the greater the risk of ocular damage.
65 10 Light Hazard (ISO 15004-2) 㼃㼛㼞㼗㼕㼚㼓㻌㼐㼛㼠㼟㻌㼘㼕㼓㼔㼠㻔㼢㼕㼟㼕㼎㼘㼑㻕 㻜 㻜㻚㻜㻜㻝 㻜㻚㻜㻜㻞 㻜㻚㻜㻜㻟 㻜㻚㻜㻜㻠 㻜㻚㻜㻜㻡 .
66 10 Light Hazard (ISO 15004-2) 㻲㼛㼏㼡㼟㻌㼐㼛㼠㼟㻌㼘㼕㼓㼔㼠㻔㻵㻾㻕 㻜 㻜㻚㻜㻜㻜㻡 㻜㻚㻜㻜㻝 㻜㻚㻜㻜㻝㻡 㻜㻚㻜㻜㻞 㻜㻚㻜㻜㻞㻡 㻜㻚㻜㻜.
67 10 Light Hazard (ISO 15004-2) 㻱㼤㼠㼑㼞㼚㼍㼘㻌㼒㼕㼤㼍㼠㼕㼛㼚㻌㼘㼕㼓㼔㼠㻔㼞㼑㼐㻕 㻜 㻜㻚㻜㻜㻞 㻜㻚㻜㻜㻠 㻜㻚㻜㻜㻢 㻜㻚㻜㻜㻤 㻜㻚㻜㻝 .
68 1 1 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.
69 1 1 Electromagnetic compatibility (IEC60601-1-2) [Compliance verication and guidance] Guidance and manufacturer ’ s declaration - electromagnetic emissions KOW A VX-20 is intended for use in the electromagnetic environment specied below . The customer or the user of KOW A VX-20 should assure that it is used in such an environment.
70 1 1 Electromagnetic compatibility (IEC60601-1-2) Guidance and manufacturer ’ s declaration - electromagnetic immunity KOW A VX-20 is intended for use in the electromagnetic environment specied below . The customer or the user of KOW A VX-20 should assure that it is used in such an environment.
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20001 So .Vermont Av e.Torrance, CA 90502, U.S.A. Phone: 1(310)327-1913 Facsimile: 1(310)327-4177 URL : http://www .kowa-usa.com/ 4-14, Nihonbashi-hon cho 3-chome, Chuo-ku, T okyo 103-8433 Japan Phone : 81(3) 3279 -7639 Facsimile : 81(3) 3279-7541 URL: http://w ww .
デバイスKowa KOWA VX-20の購入後に（又は購入する前であっても）重要なポイントは、説明書をよく読むことです。その単純な理由はいくつかあります：
Kowa KOWA VX-20をまだ購入していないなら、この製品の基本情報を理解する良い機会です。まずは上にある説明書の最初のページをご覧ください。そこにはKowa KOWA VX-20の技術情報の概要が記載されているはずです。デバイスがあなたのニーズを満たすかどうかは、ここで確認しましょう。Kowa KOWA VX-20の取扱説明書の次のページをよく読むことにより、製品の全機能やその取り扱いに関する情報を知ることができます。Kowa KOWA VX-20で得られた情報は、きっとあなたの購入の決断を手助けしてくれることでしょう。
Kowa KOWA VX-20を既にお持ちだが、まだ読んでいない場合は、上記の理由によりそれを行うべきです。そうすることにより機能を適切に使用しているか、又はKowa KOWA VX-20の不適切な取り扱いによりその寿命を短くする危険を犯していないかどうかを知ることができます。
ですが、ユーザガイドが果たす重要な役割の一つは、Kowa KOWA VX-20に関する問題の解決を支援することです。そこにはほとんどの場合、トラブルシューティング、すなわちKowa KOWA VX-20デバイスで最もよく起こりうる故障・不良とそれらの対処法についてのアドバイスを見つけることができるはずです。たとえ問題を解決できなかった場合でも、説明書にはカスタマー・サービスセンター又は最寄りのサービスセンターへの問い合わせ先等、次の対処法についての指示があるはずです。
