Kowa KOWA VX-20 manuel d'utilisation

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. Please read this manual carefully to assure that the instru[...]

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. Contact Kowa or your Kowa dealer for inspection immediately . Warning[...]

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. When moving up or down the chin rest to adjust th[...]

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. Caution for contact Caution T ake good care so that the patient’s eye,[...]

V Meanings of symbols Symbol for “Caution”. Symbol for “W arning High-voltage”. Symbol for “Caution High-tempera- ture”. Symbol for “Power ON”. Symbol for “Power OFF”. Symbol for “T ype B applied part”.[...]

VI 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 condit[...]

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[...]

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 1.5 m around a patient) when all components are installed in accordance with the installation instructions using “Multi-tap with Isolation T ransformer”, which is one of t[...]

IX 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 c[...]

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 manual: 1 Blower:1 Dust cover:1 Chin rest paper:1 Chin rest paper retaining pins:2 Compact ash memory card: 1 H ex wr e nc h es : 3 Head bands: 2 Fuse[...]

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(1.6m) VK-CB2H Card reader: 1(1.2m) VK-CB2G LAN cable(cross):1(5m) K9L-SC56B USB cable 2(A-B type):1(5m) K9L-SC56C[...]

XII MENU Introduction ............................................................................................. I Operational considerations for safety .................................................................................... I Meanings of symbols ............................................................................ V Operatin[...]

XIII 3.4 Mydriatic Fluorescein angiography procedures ....................................................... 19 3.5 Viewer mode functions and procedures .................................................................. 23 4 Advanced operation .............................................................................. 30 4.1 T ilt and panning .[...]

XIV[...]

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 capturing both non-mydriatic and mydriatic, has two photog- raphy eld angles of 50º and 30º (45º and 27º for non-mydriatic), with ability to perform[...]

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 viewnder (eyepiece) Th is i s an o pti ca l vi ew f ind er (eye - p ie c e) c a pa bl e o f us in g in my dr i - a ti c c o l or p ho to g ra ph y , Re d Fre e p h o t o g r a p h y, a n d F l u o [...]

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. Photography mode switching buttons Field angle selection bu[...]

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. It can b e us ed f or myd ri ati c co lo r ph oto gra - ph y , Re d Fre e ph ot og rap hy , F lu o - r es c en c e a ng i og r ap hy, a n d a ut o - uo re[...]

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]. Ejector button W h e n p r e[...]

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. I t count s up to 59:59 i n [...]

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. s CAPTURE button Use d for cha nging to t he Captur e mode. d Input ID button It is a b utton t[...]

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 qualied personnel who have received assembly training pro- vided by Kowa or a Kowa dealer . 2 Place the retinal camera on a stable surface, such as a powered optica[...]

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. ¿ Do not remove the compact ash memory card immediately after an image is[...]

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. Use the USB cable 1 to connect “Image output[...]

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. ¿ The power switch does not go OFF automatically . Do not forget to turn OFF the power switch. 2.[...]

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 . • Fine motion: moves the optical co[...]

13 3 Basic usage 3.2 Non-mydriatic photography/ autouorescence photography procedures This section describes the basic operation procedures for non-mydriatic and autouorescence photography . The operation of buttons e xplained in the procedures is based on the factory default. If the setti ngs have been changed, operate the buttons according [...]

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. The di[...]

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. Notice ¿ The focus dots are not displayed when using the diopter compensation le[...]

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. Be sure to read the instruc[...]

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. Press the “eld angle selection button” to select a eld angle. 6 Compensate the dio[...]

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 viewnder (eyepiece). ¿ Position the external xation target where the patient can x the vi- sion with the eye not examined. ¿ If[...]

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. Be sure to read the instruction for use carefully be[...]

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. Press the “eld angle selection button” to select a eld angle. 6 Compensate diopter[...]

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 viewnder (eyepiece). ¿ Position the external xation target where the patient can x the vi- sion with the eye not examined. ¿ If t[...]

22 3 Basic usage Photograph the image. Press the “Shutter button” to activate the ash and photograph the image. When the connection conguration in “Stand-alone” or “Network con- nection”, images are displayed in the preview window immediately after they are photographed. ¿ Holding down the shutter button allows you to con- secu[...]

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. Also, all buttons on the panel become disabled in this mode. If you g[...]

24 3 Basic usage 3.5.1 Entering an ID and switching between IDs ─ Entering an ID ─ This function is enabled while the connection conguration is in “Stand-alone” or “Network connection.” Enter a new ID. Numbers 0 through 9 and the hyphen (“ ─ ”) may be used for ID. Y ou may enter an ID directly with the keypad on the screen or r[...]

25 3 Basic usage ─ Switching to another ID ─ This function is enabled while the connection conguration 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. 2 Select an ID from the ID list shown in the ** section o[...]

26 3 Basic usage 3.5.3 Multiple image display This function is enabled while the connection conguration is “Stand-alone.” Y ou may view the images saved under an ID, up to four images at a time. ─ Four-image display ─ Press the “MUL T button” on the LCD monitor while on the single imag e display to sh ow the four mos t cur- rent imag[...]

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. Example: When 7, 3, 1 1, and 14 are se[...]

28 3 Basic usage 3.5.4 Deleting photographed images This function is enabled while the connection conguration 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. If you are certai[...]

29 3 Basic usage 3.5.5 Printing photographed images This function is enabled while the connection conguration is “Stand-alone.” Y ou may print photographed images that are saved. No ID CAPTURE IN ID/LIST REVIEW VIEW MULT PRINT TRASH SETTING While on the single-image or multiple-image display , press the “PRINT button” to print the images[...]

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. 2 T urning the tilting[...]

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. Press the “S.P . button” on the right side pa[...]

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 sufciently photographed in the current diameter setting. The inner circle is the pupil diameter that may barely be photographed i[...]

33 4 Other functions 4.3 LCD Monitoring This section describes how to perform alignment on the LCD monitor without using the optical viewnder (eyepiece) during mydriatic color photography , Red Free photography , uorescence angiography , and mydri- atic monitoring in F AF . This function eliminates the need of diopter adjustment of the optica[...]

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. Please note that xation targets are automatically switched according to the photography mode, not accord- ing to the state of the pat[...]

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. Whe[...]

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. Attaching the internal xation target 1) Remove the cover of the internal xation target socket on the optical compon[...]

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. When the ash intensity compensation knob is turned to +5, a " FLASH UP button” appears [...]

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. During the power saving mode, the Power lamp is lit in green while all other lamps, such as LED lamps, ob- servation lamps,[...]

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. Main LCD Bright Capture Date Power Saving Sound System Viewer Extension Maintenance CANCEL APPL Y[...]

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 conguration In this tab, you may set the system connection conguration of this instrument. Stand-alone: The instrument is used in stand-alone. VK connection: The instrument is connect[...]

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. Flash intensity indication: The ash intensity may be displayed on the LCD monitor as the position of the ash intensity compensation [...]

42 5 Setting 5.2.3 Image quality/color This function is enabled while the connection conguration is in “Stand-alone” or “Network connection.” ¿ In “VK connection”, the image quality and color settings for the photographed images are congured in the VK series, which allows more detailed settings. T o achieve images that are close [...]

43 5 Setting 5.4 Advanced functions 5.4.1 Internal xation target In this tab, you may congure 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. ─ Setting the photographing seq[...]

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. Aperture size : the size of the camera aperture. Standard : When the customize button[...]

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 viewnder (eyepiece). This function may be set w[...]

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 . ¿ This function is enabled while the connection congurat[...]

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. Enter a password in the “New Password” field and press “OK” next to it. Enter the sa[...]

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 . When the described remedy did not eliminate the symptom or you encountered a symp[...]

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 viewnder . Non-mydriatic mode is enabled. Y ou cannot ob[...]

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. See 7.3.1. Are the eyelashes of the patient in front of the eye? Make sure that the eyelashes d[...]

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. EPC04 The CF memory card is not inserted. Insert the CF [...]

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 . 7.1 Daily maintenance 1) Close the application of the main unit when the photographing is nished, and make sure to turn off the power switch[...]

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. Plates and labels [...]

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. Return the observation light inten- sity control knob to the 10 o'clock position after the con?[...]

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 forehead rest (including K9L-HR56 (optional accessory)), head bands, the chin rest (in case not using the chin paper), and the grip (K9L-GR56 (optional acce[...]

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. Push tigh[...]

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. 3) Insert the pulling tool attached to th e replacement [...]

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. Do not touch the [...]

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. Operations and functions of the components 5. Switching operations of photography mode [...]

60 8 Specications 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 patient’s eye 0 ─ 12D - +13D ─ ─ 10D - ─ 32D + +10D - +35D Focusing Split luminous bars coincidence (with ON/OFF function) Working distance[...]

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].Jpg [ID]_[YYMMDD]_[HHMMSS]_KOW A_ [T imer elap[...]

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 .w3.org/2001/XMLSchema-instance” xmlns:nsCommon=“http://www .joia.or .jp/st[...]

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 5.2.3. Image quality/color . The table below shows approximate number of photographs th[...]

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. Exposure to light form this instrument when operated at maximum inten- sity will exceed the safety guideline after 1874 pulses for image capturing light, 206 min[...]

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 㻜㻚㻜㻜㻢 㻟㻜㻜 㻠㻜㻜 㻡㻜㻜 㻢㻜㻜 㻣㻜㻜 㻤㻜㻜 㻥㻜㻜 㻝㻜㻜㻜 㻝㻝㻜㻜 㼣㼍㼢㼑㼘㼑㼚㼓㼠㼔㻔㼚㼙[...]

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 㻜㻚㻜㻜㻟 㻜㻚㻜㻜㻟㻡 㻜㻚㻜㻜㻠 㻜㻚㻜㻜㻠㻡 㻜㻚㻜㻜㻡 㻟㻜㻜 㻠㻜㻜 㻡㻜㻜 㻢㻜㻜 㻣㻜㻜 㻤㻜㻜 㻥㻜㻜 㻝㻜?[...]

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 㻜㻚㻜㻝㻞 㻜㻚㻜㻝㻠 㻜㻚㻜㻝㻢 㻜㻚㻜㻝㻤 㻜㻚㻜㻞 㻟㻜㻜 㻠㻜㻜 㻡㻜㻜 㻢㻜㻜 㻣㻜㻜 㻤㻜㻜 㻥㻜㻜 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. When installing or using this instrument, read the descr[...]

69 1 1 Electromagnetic compatibility (IEC60601-1-2) [Compliance verication and guidance] Guidance and manufacturer ’ s declaration - electromagnetic emissions KOW A VX-20 is intended for use in the electromagnetic environment specied below . The customer or the user of KOW A VX-20 should assure that it is used in such an environment. Emissi[...]

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 specied below . The customer or the user of KOW A VX-20 should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance l[...]

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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 .kowa. co.jp/e- life/ Kowa Company , Ltd. Hamamatsu Factory 3-1, Shinmi yakoda 1-cho [...]