(Short-Term Confidential) User Manual_1-2

FCC ID: W2Z-01000004

Users Manual

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I 1.6 Locations of Labels and Signs Locations of labels and signs affixed to the FDR D—EVO, and the relevant safety signs are shown below. 1.6.1 Locations of Labels Flat panel sensor (DR—ID 601SE) Flat panel sensor (DR—ID 602SE) fl”—”|______—i—Color Label |________—1—Color Label DR—ID 601SE Caution Label |_ DR—ID 6028E Caution Label uopesado ajeg 104 —I— DR—ID 6018E CE Mark Label |——>—IL— DR—ID 6028E CE Mark Label ..— DR—ID 6018E Identification Label LL—DR—ID 6028E Identification Label L DR—ID 6018E |_DR—1D soasE Radio Law Certification Label [| Radio Law Certification Label < — Battery.Cover Label Battery Cover Label <Exposure plane> <Exposure plane> Flat panel sensor (DR—ID 611SE) Flat panel sensor (DR—ID 612SE) _______—i—Color Label /'Color Label |L—DR—ID 6118E Caution Label L. DR—ID 6128E Caution Label l DR—ID 6118E CE Mark Label —=—IIL— DR—ID 6128E CE Mark Label .L—DR—ID 6128E Identification Label .——DR—ID 611SE Identification Label |__DR—ID 6118E |_ DR—ID 6125E [| Radio Law Certification Label Radio Law Certification Label j Battery Cover Label —Battery Cover Label ~ <Exposure plane> <Exposure plane> Flat panel sensor (DR—ID 613SE) Flat panel sensor (DR—ID 600SE) DR—ID 6135E Identification Label DR—ID 613SE Radio ‘Law Certification Label Battery Cover Label DR—ID 6008E Caution Label —ID 613SE Caution Label 1 /DR-ID 600SE CE Mark Label —ID 613SE Caution Label 2 |__——DR—ID 600SE Identification Label <Exposure plane> <Exposure plane> Control cabinet (DR—ID 600MC) DR—ID 600MC Identification Label € If the control cabinet is not included in the system, the DR—ID 600MC identification label is placed on the CD case of the software for the control cabinet. FDR D—EVO Operation Manual 897N101473R I 1—23

Power supply unit (DR—ID 60O0MP) DR—ID GOOMP Caution Label 1 —<<> DR—ID 600MP Caution Label 2 Emaa@kues: DR—ID 600MP Caution Label 3 0 0 @ DR—ID 6O0MP System Label DR—ID 600PU Rating Label L{[‘ For the types of 7z connectable cables, Ille consult a FUJIFILM dealer. uopesadop ajeg 104 <Left—hand side> <Rear side> Battery charger (optional) Battery charger Rating Label Battery pack AC adapter (Battery charger) (optional) Battery pack Rating Label AC adapter for cradle ood (optional) AC adapter for cradle Rating Label 1.6.2 DR—ID 600 Hanutctrer FUJIFILM Corporation Manufacturer FUJIFILM COI’POration MADE IN JAPAN h 26—30, NISHIAZABU 2—CHOME, MINATO—KU, TOKYO 106—8620, JAPAN 26—30, NISHIAZABU 7—CHOI ME, MINATO—KU, TOKYO 106—8620, JAPAN sssmazznc FUJIFILM FUJIFILM DIGITAL RADIOGRAPHY DIGITAL RADIOGRAPHY K c E 0123 I—_é d’ MODEL. DR—ID 600 moneL br—ID 600 === ] Sample year of Associated equipment This equipment is DR—ID 6015E _ manufacture DR—ID 600pU — DR—ID 6GOMC DR—ID 601SE CE Mark Label DR—ID 300GL Manutecturer FUJIEILM COI'POI‘athn MADE IN JAPAN c € 26—30, NISHIAZABU 2—CHOME, MINATO—KU. TOKYO 108—5520, JABAN AcsvtazissA) 0123 FUJIFILM DIGITAL RADIOGRAPHY E c €D|23 [—__l_. &I This equipment is DR—ID 6O0MP MODEL DR—D 600 man Sample year of This equipment is DR—ID 6025E J manufacture MANUFACTURED : 0 DR—ID 6025E CE Mark Label umm mm c cut) CorfiuratlonMADE IN JAPAN 26—30, NISHIAZABU 2—CHOME, M TOKYO 106—8620, JAPAN 4080240 SN FUJIFILM K Wane sapan AcNToiere DIGITAL RADIOGRAPHY C €mza CL__——3 MODEL bR—ID s00 am T «e DR—ID 600MP System Label This equipment is DR—JD 6118E ——— Sample year of DR—ID 6118E CE Mark Label manufacture 1—24 | FDR D—EVO Operation Manual 897N101473R

Manpfocurer FUJIFILM Corporation Mr‘\DE IN JAPAN Nar\ulm_l\uer FUJIFILM Cor oranon MADE IN JAPAN 26—30, NISHIAZABU 2CHOME, MINATC—KU, TG BZ lexelceleanietcit ki Lo McseidnssS(TG—KU. TOKYO 106—8620,JAPAN FUJIFILM DIGITAL RADIOGRAPHY :g C Eulza I:_:&l FLAT PANEL SENSOR & MODEL DR—JD 600 MODEL DRJD 6135E KX I <Fiek! Installed Accestory for DRID G00PU> e us This equipment is DR—ID e12sE / FUJIEILM DR—ID 6128E CE Mark Label DIGITAL RADIOGRAPHY MODEL DR—ID 600 This equipment is DR—ID 613SE &Ceec—=w Sample year of manufacture Manufacturer FUJIFILM COI’F oration MADE IN JAPAN 26—30, NISHIAZABU 2—CHOME, M 1ATG—KUTOXYO 106—8620, JAPAN t FUJIFILM DIGITAL RADIOGRAPHY MODEL DR—ID 600 id \SN uopesado ajeg 104 kThis equipmentis DR—ID 600SE DR—ID 600SE CE Mark Label —Sample year of DR—ID 613SE Identification Label manufacture tarstacurer FUJIFILM Corporation Marutsuer FUJIFILM Corporation paoo e n encuo 26—30, NISHIAZABU 2—CHOME, MINATOKU, Mssy esc onl FUJIFILM DIGITAL RADIOGRAPHY FUJIFILM DIGITAL RADIOGRAPHY (¢« MODEL DR—ID 600 MODEL DR—ID 600 C € 0123 This equipment is DR—ID 600MC This equipment is DR—ID 6OOMC MANUFACTURED : 2010 &l MANUFACTURED : 2010 (wil KX aositoags DR—ID 600MC Identification Label DR—ID 600MC Identification Label _ Battery Cover Label (for the system without the DR—ID 6OO0MC) Li—ion Battery charger FU JFILM Liion Battery charger FUJIFILM Cargador de Bateria Iepemeenttotes enR ce INPUT 1éV INPUT 16V=—4.3A OUTPUT 12.30— 1.74 wich or madity. ESbs s anylhing other than the seeifid adaptor. Pooeetateterd Eo Cnvparal cuberst uesnc H PEsuoacl M Om C € en PP ts m USIED Lopuues Corporallnn FUJIFILM Corporation Parts NO. 125¥100056 Parts NO, 125¥100056 LEUBbpEce MADE IN JAPAN AC ADAPTER FUJIFILM AC ADAPTOR FUJIFILM olbal 125Y100057________ ADAPTADOR DE cafec 125¥100057 (ue MODEL RC120G—16D [6] MODEL RC120G—16D0 [8] tastitacoso esd INPUT 100—240V~1.5A INPUT 100—240V~1.5A . c ae c 50—60Hz C 50—60Hz OUTPUT 16V=6.5A OUTPUT 16V=—6.5A E: usWzsz2e =;‘|1 CFFJ€ Chzins: NUM i EE pxll ___I k9 ba Euts n@us LISTED z MADE IN JAPAN (ooreetd ( SAFETY oo ib ) wA rer EFF[C|ENCVLEVEL® Un o e e FUJIFILM Corporation ealild e es onatanonet \‘A&‘ ts (od CAUTION :FOHINDOOR USE ONLY HOT SHORTCIRCUIT Aoidarnbaceeacilvy ‘n o mc snn‘ NALS, & m :BANq MADE IN JAPAN IflTJ?nfliJ:—h TrTa BHilia DANGEA :DOHOTOPFNEI%ANGEHOUS : DQ NoT OPEN, DANGEROUS o M :ABCARENb®DAM ADANGEH vouragEsINSlpE, TF. RORUTEAV 42 M3 Battery Pack Rating Label AC Adapter (Battery Charger) Rating Label FDR D—EVO Operation Manual B97N101473R ' 1—25

D—Link ® Model: DAP—25§3 Model No.: AF1805—A INPYT:100—120V—0.4A, 60~60Hz. LF OUTPUTAS, DV==2.5A G—C—G @ {mmw«mm::! 201 XW 00251 20YW R9r15115 Abcwnon: P—Lnk fspan KX SHOCKDO N PIN: JAP2S53IJP..A1G HIerr'MFIWVer 108 s lfil-d e mmu ite.rowen steete mmum|nu||nmm||m|mmm 7 *““2;;“;,";5:(”"“‘“” NP ElficlencyLevali@ser Emmakzs: sancfacturedby JehteTEChHNOLOGY ca, 1tb !.lllllHITJIIEIElII‘;IJIIlII?.IIHIIMI MadeinUhing Et Access Point Rating Label* AC Adapter (Access Point) Rating Label* * The access point model is subject to change. uonedado ajeg 104 SGSINPRO SWITCHING POWER SUPPLY MODEL NO.:MPUGOA—105 INPUT:100—240v 47—G3Hz. 1.62—0.72A OUTPUT12V=——5.25A max. PIN1+12V PIN3 NIC NUS . E 230351 CE HAE&HILRAILAT4 CBG A~ EN60GO1—1 s—’ iEcsosor1| *X E\/ nommam CAUTION nonoro RISK OF ELECTRIC SHOCK ATTENTION ESSthdeeems RoHS MADE IN TAIWAN AC adapter for cradle Rating Label 1—26 I FDR D—EVO Operation Manual 897N101473R

1.6.3 DR—ID 6O0PU Manufacture: FUJIFILM Corporation MAE IN JAPAN Manfactrer FUJIFILM Corporation MADE IN JAPAN — 26—30. NISHIAZABU 2:CHOME, MINATO—KU, TOKYO 106—3620, JAPAN scomeszrss 26—30, NISHIAZABU 2—CHOME, MINATO—KU, TOICYO 106—3620, JAPAN doGwtoziptA *C FLAT PANEL SENSOR FLAT PANEL SENSOR MODEL DR—ID 6018E MODEL DR—JID 6028E «Field Instalted Accessory for DT4D 600PL> «Field Installed Accessory for DTID 600PU® DR—ID 601SE Identification Label DR—ID 6028E Identification Label Manutacturer FUJIFILLM Corporation MADE IN JAPAN ecU ant.| CorPuration Eesn t 26—30, NISHIAZABU 2—CHOME, MINATO—KU. TOKYO 106—8620, JAPAN dostror30rA ‘20—30, NBHIAZABU 2:CHOME, MINATO—KU TOKYO 106—3620 JAPAN «sumazss FLAT PANEL SENSOR FLAT PANEL SENSOR MODEL DR—ID 6118E MODEL DRAD at28E <Field Instafled Accessory for DRHID GOOPU> <Field Instalfed Accassory for DRID 600PU> uopeado ajeg 4o3 DR—ID 6125E Identification Label Manufacturer FUJIFILM CorPAoratiuon MADE IN JAPAN 26—30, NISHIAZARU 2—CHOME, M NATO—KU, TOKYO 106—8620, JAPAN FLAT PANEL SENSOR MODEL DR—ID 600SE aosniotsson k SN DR—ID 600SE Identification Label Fec In:w2z—0i000001 ree iowsz.ot000004 *A ( P 1G:77368—01000001 ((é))) snhinane fim?aaaomnoom N Semacy {:, @1 5) (((l))) ‘5335-"1%*/{: é @) This davice compfes with Part 16 of FGG Rulas and Industry Cunada Rutas and Indu mpl RSS Reenco—exempt RSS stundaid{a). Operztion is subject to the tollowing ho cantitions:{1) this deviee mity nol eatusa interlernon, and (2) thin device must sccept any Interlerence, Including interteienice that may cause undaslred onertion al this davice, 4nGNIGAdE DR—ID 601SE/DR—ID 6028SE/DR—ID 611SE/DR—ID 6128E DR—ID 613SE Radio Law Certification Label Radio Law Certification Label DR—ID 600SE Caution Label Hanytectuer FUJIFILM Corporation 26—80, NISHIAZABU 2—CHOME, MINATO—KU, Lohseedueecce FUJIFILM DIGITAL RADLOGRAPHY MODEL DR—ID 6GOPU 650—60Hz 100— 240 V ~ @ 1—0.42 A \ e SN ZsNiciemc DR—ID 600PU Rating Labet ®] DR—ID 600MP Caution Label 1 A\ DR—ID 600MP Caution Label 2 / DR—ID 600MP Caution Label 3 / DR—ID 613SE Caution Label 1 DR—ID 613SE Caution Label 2 FDR D—EVO Operation Manual 897N101473R I 1—27

1.6.4 Safety and Other Symbols The following safety symbols are used in the labels or on its body. Symbol Description (E= This symbol indicates compliance of the equipment with Directive 93/42/EEC. c|6 0C »)2)©)—0O|p Caution (See "1.6.1 Locations of Labels" (page 1—23).) OFF (To indicate disconnection from the mains, at least for mains switches or their positions, and all those cases where safety is involved.) uopedado ajeg 104 ON (To indicate connection to the mains, at least for mains switches or their positions, and all those cases where safety is involved.) Protective earth (ground) Alternating current This symbol indiqates that the equipment is a Type B Applied Part. Ready (To indicate the machine is ready for operation.) 1 Electric energy General mandatory action sign Stand—by This symbol indicates that this product is not to be disposed of with your household waste, according to the WEEE Directive (2002/96/EC) and your national law. This product should be handed over to a designated collection point. Improper handling of this type of waste could have a possible negative impact on the 1% environment and human health due to potentially hazardous substances that are generally associated with EEE. At the same time, your cooperation in the correct disposal of this product will contribute to . the effective usage of natural resources. For more information about waste, please contact FUJIFILM dealers. 11 k ©[% Year of manufacture Environmentally Friendly Use Period (EFUP) [> Caution for local load (See ©1.5.3 During Exposure" (page 1—21).) 125n Wl Entire surface load FiP A0TO oDEFECT This symbol indicates that the flat panel sensor supports the automatic X—ray detection function. #+) 0 & No stepping on surface Refer to instruction manual/booklet & Do not drop the flat panel sensor to the user/patient. 1—28 I FDR D—EVO Operation Manual 897N101473R

I 1.7 Installation Conditions 1.7.1 Installation Space When Setting the Control Cabinet in the X—ray Room In case that the control cabinet is installed in the X—ray room, ensure a certain distance between the control cabinet and the upright—type or bed—type radiographic examination stand. See the figure below for reference. For the products that can be installed in patient environment, see "2.1.1 System Configuration" (page 2—1). uonpesado ajeg 103 (A_ cautions) Do not install the powe‘r supply unit, control cabinet, image processing unit, Battery charger (optional) and Access point in an area of the X—ray room, where the user can easily trip over. Falls could result in injury. m Upright type Ssn occulle h 2.5m 2.5m (8.2 ) (8.2ft) m Bed type "?‘.\'@ P i 2.5m Ns 2.5m . ------------------------ 2.5m (8.2 f) (8.2 ft) FDR D—EVO Operation Manual 897N101473R l 1—29

ewafer: uonedadp ajes 104 1—30 | FDR D—EVO Operation Manual 897N101473R

Chapter 2 System Configuration _ (Product Overview) | 21 FpR D—eEvo 2.1.1 System Configuration For the U.S. For other countries DR—ID 600 DR—ID 600 DR—ID 6O0RU DR—ID 600RU (mamuaag jonpoug) uonpeinbyuoq waysig DR—ID 600PU DR—ID 6O0PU yo m en m m mm mm nc mm e on mm m mek n mm man mer m m o o m m m mm m in o mt en m men mr mm es oes mus buk mm men y I |Flat panel sensorl |Flat panel sensorl |Flat panel sensorl 1 1 |Flat panel sensor| [Flat panel sensor] IFlat panel sensorl I I 1 I I : IFIat panel sensor| |Flat panel sensorl : : |Flat panel sensor| |Flat panel sensor| : I + ¥ + I I ¥ 1 1 : Power supply unit S : : _ Power supply unit : 1 DR—ID 600MP _ 1 1 * DR—ID 600MP i o m m mor muffes mm in mm on m mm mm mm mr mm mm es men w ol Be man moo mm mal pfeo ser se mm com m mm mt e um en bue ons bn mm ol J ¥ Control cabinet Battery Access roclen;:ige unit Control cabinet © Battery roc:erssaiae unit DR—ID 600MC charger point pDR_ID s00CL DR—ID 6oomC charger DRID sG0cL A A Y¥ ¥ ¥ Hub l l Hub t t Image processing unit of other digital radiography system Access Image processing unit of other digital radiography system DR—ID 300CL point — DR—ID 300CL * The products in [ 7 7 1 can be installed in patient environment. * The FDR D—EVO consists of the DR—ID 600RU and the image processing unit DR—ID 300CL. « An access point is used only in wireless communication mode. * The configuration of the system varies depending on the country. + Up to five flat panel sensors can be connected. Up to two flat panel sensors can be connected to one power supply unit in wired communication mode. Up to two power supply units can be used. + When the flat panel sensors are used with three to four different techniques, two power supply units are required. + Depending on the configuration, the control cabinet (DR—ID 600MC) may not be included in the system. If not included, the software for the control cabinet can be installed on the image processing unit (DR— ID 300CL). For detail specification of image processing unit, please refer to “DR-ID‘3OOCL Operation Manual". FDR D—EVO Operation Manual 897N101473R I 2—1

2.1.2 Features of the FDR D—EVO This section describes the main features of the FDR D—EVO. 1 The external dimensions and the weight of the flat panel sensor are the same as those of the conventional cassette used for general exposure. Due to this feature, the flat panel sensor can be inserted into the radiographic examination stand that has been used, allowing the user to avoid cassette replacement. The flat panel sensor can be connected/disconnected with the relay connector of the connection cable. This allows the user to carry the flat panel sensor and insert/remove it into/from the upright—type or bed—type radiographic examination stand more easily. ==~Rem: The light weight and the thin and round design increase the operability of the flat panel sensor, making it possible to place it under a lying patient. An image can be displayed on the image processing unit in as fast as approximately 1 second after X—ray exposure processing is completed. (However, the required time varies (mamaag jpnpoug) uoneinbyuos3 wajsig depending on the mode setting.) ‘ Owing to the highly sensitive flat panel sensor, X—ray exposure dose can be reduced accordingly. Due to the effects of digital image processing, the system produces X—ray images that have a high diagnostic value and are easy to observe. The system has a wide latitude for incident X—rays so that a large amount of X—ray diagnostic information is obtained. As the system has a wide latitude and an automatic sensitivity adjustment function, its X—ray images are not affected by small changes in X—ray exposure conditions. Therefore, consistent image density is obtained for all images. Image processing parameters are automatically selected through an anatomical region selection system from the image processing unit. 10 Multi—objective Frequency Processing (MFP), a newly introduced image processing function, not only improves the image quality also achieves high—speed image processing. 11 A DICOM—conformed open network can be supported by connecting the image processing unit. 12 With the flat panel sensor (DR—ID 601SE, DR—ID 602SE, DR—ID 611SE, DR—ID 612SE and DR—ID 613SE), wireless communication mode or wired communication mode can be selected. In wireless communication mode, exposures can be performed without connecting the cable. 13 The SmartSwitch is built.in the flat panel sensor with the following logo. With the SmartSwitch technology, operations for making an exposure start when the flat panel sensor detects X—rays. For this reason, it is not necessary to connect a cable to the flat panel sensor. SmartSwitch 2—2 I FDR D—EVO Operation Manual 897N101473R

| 2.2 Unit Names and the Functions Unit names and the functions of the FDR D—EVO are described below. 2.2.1 DR—ID 600 _ DR—ID 600PU hRa_~Applied part Connector Status lamp Status lamp (mamisag jonpouqg) uoneinbyuon waysig Flat panel sensor Flat panel sensor (DR—ID 613SE) (DR—ID 6018E, DR—ID 602SE, DR—ID 6118E and DR—ID 612SE) * Exposure plane is shown in this figure. * Exposure plane is shown in this figure. >A Applied part Shock sensor display (2 places) : Lights red when the shock Power sensor detects a severe impact. status LED Connector ' Main switch Status lamp Flat panel sensor (DR—ID 600SE) * Exposure plane is shown in this figure. Power supply unit (DR—ID 600MP) Name Description Flat panel sensor The DR—ID 600SE, DR—ID 601SE and DR—ID 602SE incorporate a GOS indirect panel. The DR—ID 6118E, DR—ID 6128E and DR—ID 613SE incorporate a Csl indirect panel. There are six types of flat panel sensors: DR—ID 601SE, DR—ID 602SE, DR—ID 611SE, DR—ID 6128E and DR—ID 613SE (wireless/Awired communication mode) and DR—ID 600SE (wired communication mode}). Status lamp Indicates the equipment status by LEDs. On Exposure possible READY O (Green) Blinks for 1.0| During exposure second. sequence Off Ready @ Wireless Wired POWER (Green) On "| OK (Power ON) |Power ON [— (In wireless communication READY mode, the status of the battery Blinks for 1.0| Less than 10 min POWER—\~A pack is indicated. In wired second. ~ ERROR——4 commgm_cat_lon mode, the power Off Empty (Power OFF)| Power OFF status is indicated.). . On Communication not possible. ERROR oy(Orange) Blinks for 1.0| Error occurred second. Off Normal * All LEDs are off when the equipment is off. Power supply unit Supplies the power to the flat panel sensor and connects the flat panel sensor and the (DR—ID 600MP) control cabinet. Main switch Supplies the power to the flat panel sensor and the inside of the power supply unit. Remote switch Turns on/off the power to the flat panel sensor. (optional) Power status LED Displays ON/OFF of the power supply unit. FDR D—EVO Operation Manual B97N101473R I 2—3

m DR—ID 600MC Main switch/ power status LED ==~=—Rz=: Control cabinet (DR—ID 6OOMC) Name | Description (matmisag jonpoug) uopeinbyuo3 warsig Control cabinet A personal computer used for controlling the flat panel sensor and (DR—ID 600MC) performing image processing. Main switch . Supplies the power to the control cabinet. Power status LED Displays ON/OFF of the control cabinet. & Depending on theconfiguration, the control cabinet (DR—ID 600MC) may not be included in the system. If not included, the software for the control cabinet can be installed on the image processing unit (DR—ID 300CL). For detail specification of image processing unit, please refer to "DR—ID 300CL Operation Manual". = Battery charger (Optional) PA Battery charger Name — . Description Battery charger Charges the battery pack (optional) for the flat panel sensor (DR—ID 601SE, DR—ID 602SE, DR—ID 611SE, DR—ID 6125E and DR—ID 613SE). Three packs can be charged at the same time. . Charge status indicator LED Indicates charge status. s# Access point * Product compliant with IEC60950, UL60950, PSE or JIS « Compliant with IEEE802.11n [W52] (in the 5.2GHz band) /36, 40, 44, 48ch * WLAN interface: 1000BASE—T/A10OBASE—TX (minimum requirements) *« LAN interface: 1000BASE—T/100BASE—TX (minimum requirements) + Available OS: Linux + Compliant with UL + Compliant with FCC part15 m DR—ID 300CL | © For the unit names and functions of the DR—ID 300CL, see the "DR—ID 300CL Operation Manual". 2.—4 | FDR D—EVO Operation Manual 897N101473R

=# AC adapter for cradle (optional) Cradle {optional) SE cable for charging AC adapter AC adapter for cradle Name Description (mamuiaag jonpoug) uoneinbyuo3 wa;sig AC adapter for cradle Charge the flat panel sensor (DR—ID 601SE, DR—ID 602SE, DR—ID 611SE, DR—ID 612SE and DR—ID 613SE) by combining it with the separately sold cradle or Cradle for 24. (A_ cautions___) e Do not connect directly to the flat panel sensor when the AC adapter for cradle is not connected to the cradle. . e Do not use a flat panel sensor that is being charged with the AC adapter for cradle for an exposure. The image being exposed may not be acquired correctly. FDR D—EVO Operation Manual 897N101473R | 2—5

2.3 Image Processing Unit‘s Display Configuration When the self—initialization process ends, the Patient Information Input Screen will appear on the image processing unit‘s display. © For details, see "DR—ID 300CL Operation Manual". ® Patient Information Input Screen Patient information input field Input patient information. [ges—— Tool button P Patient (D en ie E—— Operates the Patient Information Accession No. Database function to input patient information. (mamaag jnpoug) uogeinbyuos3 waysig Sex Huibnooac ces eeeicusueeicid beeeduepereibes eucnpIsrcs Patient comments Study comments P ®sgee—— Clears patient information C n olone (except for technologist). — Q W oE R T Y U } | Pss 208 tommmmaaem— Screen keyboard Used to input characters in the A—a Z X C V B N M ? B © patient information input field. input, and proceeds to exposure menu selection. Displays the "StudyList screen". _ Connected devices status Connected devices status display field. Displays the status of connected devices. ®= Study Screen Patient information display field Displays patient information. 2. JOHN SMITH or, 2234567899 P ol a Ne (2004.FE CHEST,FRN PA 11‘,1 1mx17 MB—+ onmmeme—— EXDOSUTE MEnLu |iSt This list shows exposure menus selected on the "Exposure Menu Selection screen". Selected exposure menu number display field e— Exposure unit display field The Tube, Technique, and Imaging panels can be uniquely arranged and displayed. Technologist display field Displays the nameof logged—in o s E& @ (_) FJ!II us r!;' h@ 1 [ technologist (user). s E_ Image display field Shot Ready (exposure ready status indicator) The read image appears. Exposure (image reading) can be performed when the indicator is lit green. Exposure (image reading) cannot be performed when the indicator is not lit. 2—0 | FDR D—EVO Operation Manual 897N101473R

m Connected Devices Status Details on each icon and its display area are described below. ‘ Login:00 =——N= Other indicator icons display area Other indicator icons display area (mamaag jpnpoug) uoneinbyuos3 waysig The status of the flat panel sensor and that of the image processing unit are displayed as icons. The status of each connected device is shown in three categories. Device information displayed in each category is as follows. Category Device information Status of exposure unit (1) Exposure unit communication indicator (2) Exposure unit battery indicator Status of the image processing unit (3) Console event indicator Other (Status of output unit) (4) Output status indicator The information is displayed in each category as shown below. Device information of the category Category Locations of categofy information can be customized in the user utility. For details, see "DR—ID 300CL Reference Guide". ' FDR D—EVO Operation Manual 897N101473R I 2—]7

(1) Exposure Unit Communication indicator The following icons display communication status of the flat panel sensor corresponding to the selector selected in the exposure unit display field of the "Study screen". If the flat panel sensor has a wired connection, the following icons are displayed. DSQ : Connected _ 3 : Disconnected If the flat panel sensor is connects wirelessly, the following icons are displayed. <<NMzs: m][]fl / yl 1 Y : Connected. Displays the signal strength in three levels. mg | W& : Disconnected W@ : Unknown (mamiaag jpnpoig) uonjeinbyuo3 waysig (2) Exposure Unit Battery Indicator When the exposure unit is connected to the image processing unit, the battery status is indicated with the following icons. ' CBe : Ready for exposure (battery charge: fully charged) : Ready for exposure (exposure time available: less than one hour) : Ready for exposure (battery charge: recharge needed) =[Lle : Ready for exposure (charging) BB : Not ready for exposure a (A.____cautions__ ) When an exposure is ready to be made (the READY status lamp on the flat panel sensor is lit green}, the power consumption of the flat panel sensor increases. Although the indicator icon of the remaining battery level changes to low and the value of the operable time display decreases temporarily, these are not failures. (3) Console Event Indicator The following icons display the status of the image processing unit. : Normal : Warning—level event ongoing B : Error—level event ongoing (4) Output Status Indicator The following icons display the output status. D : Waiting for image output @ : Processing image output B : Output error 2—8 I FDR D—EVO Operation Manual 897N101473R

I 2.4 Routine Operation Diagram The system configuration and the routine operation diagram for the FDR D—EVO is as follows. FDR D—EVO (DR—ID 600) DR—ID 600PU and DR—ID 6O0MC DR—ID 300CL mN’m X—ray exposure Image data a *« Patient nformatition ent ry inf « Image reading + Exposure region / study menu selection *« Image processing, etc. (mamiaag jonpoug) uoneinbyuo3 ma;sks‘ Image data ¥ Image J data Imager * Film output Y¥ Image Management Workstation * DICOM—conformed open network supported FDR D—EVO Operation Manual 897N101473R l 29

L25 Wireless Specifications 1 Technical Specification : IEEE802.11.n (protocol) , W52 (frequency) 2 Intended environment : Room size of 10m x 10m x 3m (32.8 ft x 32.8 ft x 9.8 ft) (height) or less (general X—ray room) (The electric shield does not exist excluding the installation stand or bed.) 3 Installation : DR—ID 601SE/DR—ID 602SE/DR—ID 611SE/DR—ID 612SE/DR—ID 613SE and Access Point must be installed in the same room. Do not place Access Point within the reach of patients. Do not Place more than one Access point in the same room. Do not place devices generating electromagnetic wave (CT,MRI, diathermy, RFID etc.) near this equipment. We recommend not to use any other wireless devices such as cellular/smart phones, portable phones, microwave ovens, WAPs, etc. within 2m (6.6 ft) of the wireless D—EVO system. (mamusag jonpoug) uogeinbyuos3 waysig When other wireless devices are used within 2m (6.6 ft), wireless data communication may be delayed. (Data communication is guaranteed. If timeout occured, retry can be done.) Do not change the position of the access point once installed. Do not cover the Flat Panel Sensor (DR—ID 601SE/DR—ID 602SE/DR—ID 611SE/DR—ID 612SE/DR—ID 613SE) with a shield such as a metallic plate as this will interfere with a wireless communication. Information being transmitted : X—ray Control Signal (Prep—SW, Shot—SW) System Control Signal, (Img_req_CMD, etc..) Image Data(Raw data Before Image processing)(Note: Patient Information is not transmitted by wireless interface.) Wireless range : max. 10m (32.8 ft) from the Access point as tested. Actual range may vary. Data transfer rate : 35Mbps (This value is FUJIFILM measuring result of wireless module, and actual data rate may vary.) Transfer Power : 12.26 dBm or less (13.89 dBm or less for the DR—ID 613SE) (According to FCC part15 test report) Modulation : OFDM (Provided by IEEE802.11 .n standard) "RADIO TEST" is executed to this product according to FCC part15 subpart E: 2010 standard. All the test items are passed. Wireless Data Security : Wireless D—EVO system (DR—ID600 with DR—ID 601SE/DR—ID 602SE/ DR—ID 611SE/DR—ID 612SE/DR—ID 613SE) will be utilizing the IEEE standard 802.11.n at the 5.2GHz frequency, which will allow us a maximum wireless signal rate of up to 35Mbps. The Wireless Access Point (WAP) has a feature that limits the maximum number of users per Access Point to ensure data integrity. Further the WAP has MAC Address Filtering (unique IP address) and Wireless LAN Segmentation to ensure handshaking with only the registered wireless D—EVO Flat Panel Sensors (DR—ID 601SE/DR—ID 602SE/ DR—ID 611SE/DR—ID 612SE/DR—ID 613SE). In addition to the MAC address filtering, the wireless communication between DR—ID 601 SE/DR—ID 602SE/DR—ID 611SE/DR—ID 612SE/ DR—ID 613SE (Flat Panel Sensor) and the wireless access point is secured by WPA2—PSK encryption with AES (Advanced Encryption Standard). Data security feature will be enabled during installation by a FUJIFILM field service engineer. No patient information is transmitted between DR—ID 601SE/DR—ID 602SE/DR—ID 611SE/ DR—ID 612SE/DR—ID 613SE (Flat Panel Sensor) and Wireless Access Point. 2—1 0 I FDR D—EVO Operation Manual 897N101473R

10 Handshaking/Pairing : The Wireless Access Point and DR—ID 601SE/DR—ID 602SE/DR—ID 611SE/DR—ID 612SE/DR—ID 613SE (Flat Panel Sensor) will be paired during installation by a FUJIFILM field service engineer to ensure one—to—one wireless connection. FUJIFILM field service engineer will measure the wireless transmission speed during installation to find the best position of the wireless access point and the wireless D—EVO system. 11 Frequency Tolerance : £20ppm Quality of Service (QoS) (For DR—ID 601SE/DR—ID 602SE/DR—ID 611SE/DR—ID 612SE) N Item Standard Unit Remarks Form of electric Spectrum diffusion — wave Center frequency HT20 5180—5240 MHz 36ch,40ch,44ch,48ch WS2 (mamuaag jpnpoug) uoneinbyuo3 waysig HT40 5190—5230 (MHz 38ch,46ch W5S2 Channel interval IEEE802.11.n 20(HT20) / 40(HT40) MHz Transmission rate IEEE802.11.n 11n HT20 : MCS 0—15 — 11n HT40 : MCS 0—15 Modulation OFDM (64QAM, 16QAM, QPSK,BPSK) — Output power HT20 Max 11.82* dBm HT40 Max 12.26* dBm Frequency «20 ~+20 ppm MAX Tolerance Reception MCSO, 8 —82 dBm HT20 sensitivity MCS1, 9 —79 dBm (PER (Packet Error MCS2, 10 77 dBm Rate)<10%) MCso, 8 —79 dem HT40 MCS1, 9 —76 dBm MCS2, 10 ~74 dBm Current TX5G 650 (Typ) mA Thruput test mode consumption RX5G 450 (Typ) mA Thruput test mode *The value is based on the FCC report of the Flat Panel Sensor. Quality of Service (QoS) (For DR—ID 613SE) Standard Remarks Form of electric Spectrum diffusion wave Center frequency HT20 5180—5240 MHz 36ch,40ch,44ch,48ch WS2 HT40 5190—5230 MHz 38ch,46ch W5S2 Channel interval IEEE802.11.n 20(HT20) / 40(HT40) MHz Transmission rate IEEE802.11.n 11n HT20 : MCS 0—15 = 11n HT40 : MCS 0—15 Modulation OFDM (64QAM, 16QAM,QPSK,BPSK) — Output power ~ HT20 Max 13.84* dBm ' HT40 Max 13.89* dBm Frequency —20 ~+20 ppm MAX Tolerance Reception MCSO, 8 —82 dBm HT20 sensitivity MCS1, 9 —79 dBm (PER (Packet Error MCS2, 10 —77 dBm Rate)<10%) McCSo, 8 79 dBm HT40 MCS1, 9 «76 dBm MCS2, 10 —74 dBm Current TX5G 550 (Typ) mA Thruput test mode consumption RX5G 450 (Typ) mA Thruput test mode *The value is based on the FCC report of the Flat Panel Sensor. FDR D—EVO Operation Manual 897N101473R | 2—11

S@N== System Configuration (Product Overview) 2—12 l FDR D—EVO Operation Manual 897N101473R

Chapter 3 Basic Operation | 3.1 Preparing the Flat Panel Sensor This section describes how to prepare the flat panel sensor. 3.1.1 Type of Flat Panel Sensor DR—ID 601SE, DR—ID 602SE, DR—ID 611SE, DR—ID 612SE and DR—ID 613SE : Wireless communication mode or wired communication mode is available. When used in wireless communication mode, an access point*‘, battery pack (optional) and battery charger (optional) are required. *1 In the countries other than the U.S., an access point is not included as a component of the system. For details including installation, consult our official dealer. * Product compliant with IEC60950, ULS60950, PSE or JIS *« Compliant with IEEE802.11n [W52] (in the 5.2GHz band) /36, 40, 44, 48ch * WLAN interface: 1000BASE—T/AOOBASE—TX (minimum requirements) uogeiadp aiseg * LAN interface: 1000BASE—T/M0OOBASE—TX (minimum requirements) * Available OS: Linux « Compliant with UL > *« Compliant with FCC part15 CA_ ~cautions _ Use only one access point. A communication error may occur if two units or more are used. DR—ID 800SE : Wired communication mode 3.1.2 Number of the Connectable Flat Panel Sensors To enable the flat panel sensor, its ID needs to be registered in advance by a FUJIFILM dealer. Up to a hundred flat panel sensors can be registered. Up to five flat panel sensors can be connected. Up to two flat panel sensors can be connected to one power supply unit in wired communication mode. Up to two power supply units can be used. & Depending on the configuration, the control cabinet (DR—ID 600MC) may not be included in the system. If not included, the software for the control cabinet can be installed on the image processing unit (DR—ID 300CL). For detail specification of image processing unit, please refer to "DR—ID 300CL Operation Manual". FDR D—EVO Operation Manual 897N101473R I 3—1

3.1.3 Connecting/Disconnecting the Flat Panel Sensor (DR—ID 601SE, DR— ID 602SE, DR—ID 611SE, DR—ID 6125E and DR—ID 613SE) Connector When used in wireless communication mode, disconnect the connector. Disconnect the connector. E : Connect the connector. Press the latches on both sides of the connector. Press the connector into the insertion section. s Wfl Make sure that the latches on both S|des are properly engaged when connecting the connector. If the flat panel sensor is used with the connector inserted incompletely, the flat panel sensor may turn off. & Connect/Disconnect the connector straight to the flat panel sensor. If connected/disconnected at an angle, the uonpedadp aiseg connector may be damaged. 3—2 I FDR D—EVO Operation Manual 897N101473R

3.1.4 Connecting/Disconnecting the Sensor Cable Relay Connector for the Flat Panel Sensor (DR—ID 600SE) Follow the procedure below to connect/disconnect the sensor cable relay connector. & + Do not connect the flat panel sensor to the power supply unit other than of the FDR D—EVO. Otherwise, the connector may be damaged. + Do not connect the flat panel sensor unregistered to the system. Otherwise, the power to the flat panel sensor will be disconnected automatically. For details on the registration, contact a FUJIFILM dealer. « When connecting/disconnecting the sensor cable relay connector, always hold the grip of the connector. The wire inside may be broken, if you connect/disconnect by holding the cable, If you turn the outer bushing of the grip, the cable lock becomes loose, causing a short—circuit of the cable. + Do not drop the sensor cable relay connector when connecting/disconnecting it, Otherwise, personal injury may result, or properties or the connector may be damaged. * Do not connect an 8.5m(27.9 ft)—long cable for the power supply unit and that for the flat panel sensor of the same length. If the total length of the connected cables exceeds 10m (32.8 ft), the flat panel sensor may malfunction. n Make sure that the READY lamp of the flat CA CAUTioNS D panel sensor is not blinking, and press the OFF side of the power supply unit. If you skip Step and perform Step B, uopesadpo aiseg Alternatively, turn off the flat panel sensor a communication error occurs. In such a by pressing the operation button on the case, turn the power back on to the power optional remote switch, and make sure that supply unit. Note, however, that repeating the POWER lamp of the flat panel sensor this action may result in damage to the turns off. equipment. © For the external view of the optional remote switch, see "O.2 Using the Remote Switch" B To connect, align the positioning marks, (page O—3). and then push the connectors in. & Align the positioning mark on the connector of the The remote switch can be simultaneously connected power supply unit with that of the flat panel sensor, to both the upright type and the bed type. and then insert the connectors by slightly turning The relay connector can be connected/disconnected them. by turning off either of the remote switches. Positioning mark €] $ t3 ) You can proceed to the next step even if an error message appears after turning off the power supply unit. ' Grip /Locking latch \ Grip Push in until you feel a click. E To disconnect, hold the grips A and B of 2mm(0.08 in.) to 3mm(0.12 in.) both the connectors, and then pull the grip A of the flat panel sensor to unlock. Flat panel sensor Power supply unit SA S Push further in to the position shown in the figure in Step B until you feel a click again to lock them into Grip A Grip B place. n Press the ON side of the main switch of the power supply unit, or press the operation button on the optional remote switch. FDR D—EVO Operation Manual 897N1O1473R | 3.3

3.1.5 Connecting/Disconnecting the AC adapter for cradle (optional) Relay Connector Follow the procedure below to connect/disconnect the AC adapter for cradle relay connector. & * When connecting/disconnecting relay connector, always hold the grip of the connector. The wire inside may be broken, if you connect/disconnect by holding the cable. * Do not drop relay connector when connecting/disconnecting it. Otherwise, personal infury may result, or properties or the connector may be damaged. n Remove the AC adapter for cradle power cable from the power outlet, and check that the AC adapter LED has turned off. E To disconnect the adapter, pull the grip on the side of the flat panel sensor while pressing the lock button. Flat panel sensor side AC adapter side uopeladp aisegq Lock button / iCBGrip fl To connect the adapter, align both sides of the relay connector withthe terminal position, and insert it until it makes a clicking sound. D W Flat panel sensor AC adapter side terminal side terminal _ n Connect the AC adapter for cradle power cable to the power outlet, and check that the AC adapter LED has turned on. 3—4 | FDR D—EVO Operation Manual 897N101473R

3.1.6 Inserting/Removing the Flat Panel Sensor into/from the Radiographic Examination Stand Follow the procedure below to insert/remove the flat panel sensor into/from the radiographic examination stand. © For details, see the Operation Manual for the radiographic examination stand. (A\.____CcaUTioNns_____) For the positioning at the time of inserting/removing the flat panel sensor, see the Operation Manual for the radiographic examination stand. (A. __ caUutions_) Be careful not to have your fingers caught when inserting/removing the flat panel sensor into/ from the radiographic examination stand. When pulling out/pushing in the tray of the radiographic examination stand after setting the flat panel sensor on it, be careful not to drop the flat panel sensor or damage the tray. uoneiadp aisegq (A ~~~~cAumions ) Before inserting/removing the flat panel sensor into/from the radiographic examination stand, pull out the tray completely. Otherwise, the flat panel sensor may be damaged. © ‘For the effective area of the flat panel sensor, see page A—7. FDR D—EVO Operation Manual B97N101473R | 3—5

[1] Uprlght type - n Push the tray back into place after setting ; & . . . the flat panel sensor. When inserting from the right—hand side (A\ CAUTIONS 0 When inserting the flat panel sensor into the radiographic examination stand, direct the exposure plane toward the X—ray tube. n Pull out the tray. : When inserting the flat panel sensor from the left— C D _Trey : hand side, direct the connector to the lower left. uoriadp aisegq E Insert the flat panel sensor into the cassette receive while the connector directed to the upper right, and then move it downwards. E Remove the flat panel sensor after use. Pull out the tray, push the cassette receive downwards, and then remove the flat panel sensor. Connector : Push the tray back into place. Cassette receive 3—6 ‘ FDR D—EVO Operation Manual 897N101473R

[2] Bed type CA _ cAUutions __ When inserting the flat panel sensor to the radiographic examination stand, direct the exposure plane upwards. M rutl out the tray by using the nanale. When setting the flat panel sensor horizontally, position the connector as shown in the figure below. uonpesadp a1seg E Pull the cassette stopper, and set the flat panel sensor so that its center mark is aligned with the center of the stopper. + B Push the tray back into place by using the Position the connector of the flat panel sensor as : handle after setting the flat panel sensor. shown in the figure below. 1 stopper n Remove the flat panel sensor after use. Hold the handle and pull out the tray. Remove the 1 flat panel sensor while pulling the cassette stopper, i and then push the tray back into place. 3.1.7 Changing the Direction of the Flat Panel Sensor Connector The direction of the connector of the flat panel sensor can be changed, depending on how it is inserted into the radiographic examination stand. To change the direction, contact a FUJIFILM dealer. m * —i—<p fo— When shipped After changing the direction FDR D—EVO Operation Manual 897N101473R I 3—7

3.1.8 Charging the Battery Pack (Optional) for the Flat Panel Sensor (DR—ID 601SE, DR—ID 602SE, DR—ID 611SE, DR—ID 612SE and DR—ID 613SE) When used in wireless communication mode, charge the battery pack (optional) using the battery charger (optional). CA cAUTions ) Do not charge the battery pack other than those designated by FUJIFILM Corporation. If the battery pack is charged under the charging conditions (voltage, current and charging method) different from those specified by FUVJIFILM Corporation, the battery pack may emit smoke, ignite, explode or leak fluid. CA ~~~cautions y =>=@rs When setting the battery pack into the battery charger, make sure that the orientation of the battery pack is correct as shown in the figure in Step KKIf the battery pack is forcibly set in the wrong orientation, both the battery pack and the battery charger may be damaged and emit uogesado aiseq smoke, ignite, leak fluid or cause electric shock. € When a new battery pack is fully charged, it is possible to perform exposures for a maximum of approximately 750 images for DR—ID 601SE, approximately 500 images for DR—ID 602SE/DR—ID 611SE/DR—ID 612SE and approximately 700 images for DR—ID 613SE. However, the number varies depending on the usage conditions. & The capacity of the battery is displayed on the POWER status lamp and in the image processing unit‘s display. & When the remaining capacity of the battery pack becomes less than 10 minutes, a 'pop-up Wifidow appears on the image processing unit, and exposures cannot be performed. If this happens, perform the following operations. * Replace or charge the battery pack. * Connect the connector to the flat panel sensor. & When the connector is connected to the flat panel sensor, exposures in wired communication mode and charging the battery pack can be performed. & Charge the battery pack using the battery charger. In wireless communication mode, when the remaining capacity of the battery pack becomes insufficient, exposures are prohibited and the POWER status lamp blinks every one second. If the flat panel sensor is used in wireless communication mode for another 10 minutes or so, the battery pack is not charged even if the SE cable is connected. If this happens, remove the battery pack and charge it using the battery charger. When the battery pack is charged using the battery charger for about one minute, charging the battery pack by connecting the SE cable become available. 3-8 | FDR D—EVO Operation Manual 897N101473R

n Set the battery pack in the battery charger. 7 : E When battery charge is confipleted, remove the battery pack. When the battery pack is set, a buzzer sound is generated and the charge‘status indicator LED When battery charge is completed, the charge status lights. indicator LED changes from blinking to lighting. Three battery packs can be charged at the same time. ==(@rm 3.1.9 Installing/Removing the Battery Pack (Optional) for the Flat Panel Sensor (DR—ID 601SE, DR—ID 602SE, DR—ID 611SE, DR—ID 612SE and DR—ID 613SE) uogesado Jiseq Follow the procedure below to install/remove the battery pack (optional) for the flat panel sensor. & When installing/removing the battery pack, place the flat panel sensor on a flat place. Remove the battery cover. Slide the battery pack along the dent of the battery section of the flat panel sensor toward the connector Place the flat panel sensor with the back side facing terminal. Align the guide mark of the battery pack upward, and then simultaneously slide both the with that of the flat panel sensor, and push the battery lock release latches outward to remove the battery pack in to install it. battery cover. Make sure that battery pack is securely installed. & Pushing the battery pack in with the guide marks misaligned may damage the connector terminal. & When the battery pack is installed, the power is automatically turned on. Battery cover E Install the battery pack. Make sure that the battery lock release latches are released. When the battery lock release latches are released Battery pack * To remove the battery pack, perform the same procedure as Step n {removing the battery cover). * To install the battery cover, perform the same procedure as Step fl (installing the battery pack). Battery lock release latches FDR D—EVO Operation Manual 897N101473R | 3—9


Document Created: 2015-07-24 09:30:01
Document Modified: 2015-07-24 09:30:01
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