REGIUS MODEL 190 (DD-941)

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1 DIRECT DIGITIZER REGIUS MODEL 190 (DD-941) PRE-INSTALLATION GUIDE CODE NO.0676 No. 26-2, Nishishinjuku 1-chome, Shinjuku-ku, Tokyo , Japan

2 Table of Contents Foreword... 2 Characteristics of REGIUS Overall Cautions System Overview 1.1 Specification External Dimensions Name of Parts and Function X-ray Exposure Procedure (Flowchart) Route of Movements when Performing X-ray Exposure When connected to CS-3/CS When connected to CS Operation Overview When connected to CS-3/CS-1 From Image Reading to Image Data Storage Transfer of Image Data Image Reading (1-to-1 Connection) Image Reading (n-to-m Connection) When connected to CS-2 From Image Reading to Image Data Storage Transfer of Image Data Image Reading (1-to-1 Connection) Image Reading (n-to-m Connection) Installation Overview 3.1 Installation Conditions Place of Installation Installation Space Route of Conveyance Dimensions and Weight of the Machine Example of Installation System Example When connected to CS-3/CS When connected to CS Connections Overview 4.1 Diagram of Connections List of Cables... 21

3 < Cautions > (1) Unauthorised reproduction of this manual in whole or in part is prohibited. (2) The content of this manual is subject to change without prior notice. (3) Should any discrepancies, errors or omissions be discovered, Konica Minolta Medical & Graphic, Inc. should be contacted. (4) Notwithstanding Item (3) above, Konica Minolta Medical & Graphic, Inc. shall accept no responsibility for any claims made against loss or loss of profits arising from use of the product. Trademarks - Other company or product names used in this manual are trademarks or registered trademarks. The indications, and shall be omitted henceforth.

4 Foreword The Direct Digitizer REGIUS MODEL 190 (henceforth referred to as "REGIUS 190") is a device for reading of X-ray image cassettes using photostimulable phosphor substance as the X-ray detector. This Pre-installation Guide sets out the preparations deemed necessary prior to installation of REGIUS 190. Characteristics of REGIUS 190 (1) The system directly digitizes X-ray image data using photostimulable phosphor substance plates. (2) Features a wide dynamic range not available on X-ray film and enables acquisition of large quantities of X-ray diagnostic data. (3) Features a wide latitude in respect of irradiating X-rays and keeps to a minimum the effects caused by variation in X-ray exposure. (4) Features a cassette feed/load time of approximately 40 seconds when reading image sizes of 14"X14" at 175ı enabling performance of reading without the patient being inconvenienced by undue waiting time. (5) Images are displayed on the CS-3/CS-1 operation unit immediately after exposure, enabling instant confirmation of images. (6) The read pixel pitch may be selected from three types (43.75ı*, 87.5ı and 175ı). * : A separate license is required for the optional sampling pitch (43.75ı). (7) A new scanning method using a semi-conductor laser is featured enabling realization of an extremely compact size (Footprint: 58cm X 58cm). (8) The unit features a function allowing transfer of digital images to the host computer and can thus be used as a PACS X-ray image input device. (9) A maximum of 16 REGIUS 190 units may be connected to one REGIUS CONSOLE CS-3 (henceforth referred to as "CS-3") or REGIUS CONSOLE CS-1 (henceforth referred to as "CS-1"). Overall Cautions Be certain to comply with any and all laws and government regulations including electric codes and utility regulations, regarding the installation and operation of this equipment.

5 1 System Overview 1.1 Specification Device Type : Model Name : CODE No. : Safety Standard : Exposure size (note 1) : Sampling Pitch (note 2) : Maximum Resolution : Digital Gradation Level : Cycle Time : Cassette Feed/Load Time (note 3) : Slots : Dimensions : Weight : Power Source : Heat Generated : Operating Condition : Storage and Transportation Condition : Noise Level : Classification : Electromagnetic Conformity : Accessories : Options : DIRECT DIGITIZER DD-941 DIRECT DIGITIZER REGIUS MODEL IEC , IEC60825 Regular : 14"X17" / 14"X14" / 11"X14" / 10"X12" / 8"X10" / 24X30cm / 18X24cm Mammography *: 24X30cm / 18X24cm Pantomography : 15X30cm three types (43.75ı *, 87.5ı and 175ı) 7080X9480 pixels 4096 steps (12bits) 90 sh / hr (14"X14" / 175ı ) approx. 40sec. (14"X14" / 175ı) Insertion X1 (+1 stack) Exit X1 (four cassettes in stack) 580(W)X580(D)X1230(H) mm approx. 170kg (excluding the cassette) AC100 ~ 240V 10% (50/60Hz), 1.1kW Approx. 1300kJ max. (approx. 310kcal) 15 ~ 30: / 35 ~ 80RH% (no condensation) -10 ~ 40: / 10 ~ 95RH% (no condensation) 60 db or less Class II (510K) IEC Power Cable, Operation Manual REGIUS Cassette, REGIUS Console, JM, JM-BOX note 1 ; * = Except the USA. note 2 ; * = A separate license is required for the optional sampling pitch. note 3 ; Time from cassette to cassette ejection. In the interests of product quality, the above specifications are subject to change without notice.

6 1.2 External Dimensions (Given in mm)

7

8 1.3 Name of Parts and Function Front LCD Panel "operation" Button "operation" Lamp (green) "erase" Lamp (green) "erase" Button Cassette Ejection Lamp READY Lamp Ejection Slot Shutter Cassette Stacker "eject" Button Front Door Cassette Insertion Slot Back Ethernet Port Exhaust Port AC Inlet Power Supply Breaker

9 Function "operation" Button : "erase" Button (Yellow) : "eject" Button : READY Lamp : "operation" Lamp (Green) : "erase" Lamp (Orange) : Cassette Ejection Lamp : LCD Panel : Front Door : Cassette Insertion Slot : Cassette Stacker : Ejection Slot Shutter : Exhaust Outlet : Ethernet Port : AC Inlet : Power Supply Breaker : Used to turn the device ON/OFF. The device initializes when turned ON. Used to erase image data from REGIUS plates. Used to eject cassette wrongly inserted. Illuminates (blue) to show that the device is in ready status. Illuminates when the operation button is switched ON. Illuminates in the erase mode. Flashes when a cassette is ejected (orange). Displays errors and device status. To be opened in the event of a cassette jam. The cassette is inserted here. Stacks cassettes ejected after completion of REGIUS plate reading and deletion. Opens/Closes when cassette is ejected. Provided to prevent rise in the internal temperature of the device. Used for Ethernet cable connection for link to CS-3/CS-1 or network. The power supply cable is connected here. Turns REGIUS MODEL 190 Main Body power ON/OFF.

10 1.4 X-ray Exposure Procedure (Flowchart) The exposure procedure flow followed by the technician is shown below. Start d 1 2 Order registration using Console d Selection of cassette matching the body part to be photographed d 3 Registration of barcode using barcode reader or Menu selection on Console screen d Enters X-ray room 4 d X-ray exposure d Leaves X-ray room d Insertion of cassette into REGIUS 190 d Image check and output on Console d Ejection of cassette from REGIUS 190 d Return of cassette ejected from REGIUS 190 to cassette rack d Completion

11 XXXXXXXXXXXxxxxx XXXXXXXXXXXxxxxx XXXXXXXXXXXxxxxx XXXXXXXXXXXxxxxx X X XXXX XXXX Xxxx xx 1.5 Route of Movements when Performing X-ray Exposure The route of movements when performing X-ray exposure is shown below. The exposure sequence is indicated by the encircled numbers. Any obstacles impeding the route of movement should be removed before carrying out X-ray exposure. Additionally, the system should laid out so as to ensure sufficient space to ensure that work can be carried out smoothly. When connected to CS-3/CS-1 X-ray exposure. X-ray exposure room CS-3/CS-1 Order registration using CS-3/CS-1. Barcode registration using barcode reader or selection from CS-3/CS-1 on-screen menu. Image check and output using CS-3/CS-1. REGIUS 190 Cassette Rack for Mammography for Mammography RP-3M RP-3M Insertion of cassette into REGIUS 190. Ejection of cassette from REGIUS for Mammography for Mammography RP-3M RP-3M Selection of cassette. Return of cassette ejected from REGIUS 190 to cassette rack.

12 XXXXXXXXXXXxxxxx XXXXXXXXX X Xxxxxx XXXXXXXXXXXxxxxx XXX X XXXXXXXxxxxx XXXXXXXXXXXxxxxx When connected to CS-2 X-ray exposure. X-ray exposure room CS-2 Order registration using CS-2. Auto-registration, Barcode registration using barcode reader or selection from CS-2 on-screen menu. Image check and output using CS-2. REGIUS 190 Cassette Rack for Mammography for Mammography RP-3M RP-3M Insertion of cassette into REGIUS 190. Ejection of cassette from REGIUS for Mammography for Mammography RP-3M RP-3M Selection of cassette. Return of cassette ejected from REGIUS 190 to cassette rack.

13 2 Operation Overview The flow of X-ray image data within the REGIUS 190 systems is shown below. When connected to CS-3/CS-1 From Image Reading to Image Data Storage Image Processing Parameter Exposed Cassette Setting Process Parameter QA Value Exam Tag Gradation Processing Display CS-3/CS-1 Operation Unit Read REGIUS 190 CS-3/CS-1 or RIS/IDS Input ID Info. ID Info. Process Parameter LUT Save To cpnnected devices Output D I C O M Image Data Image Data Harddisk The image data read to REGIUS MODEL 190 displayed on CS-3/CS-1 after undergoing image processing according to "processing data." Additionally, "patient data" and "processing data" are added to this image data and the resulting data stored as image data for one patient on the hard disk in the CS-3/CS-1 control unit. Transfer of Image Data When image output is requested, the image data stored on the hard disk is output to the host and other externally-connected devices. The movement in CS-3/CS-1 when data is transferred is shown below. Patient Data Image Process Parameter From Cassette Image Storage Processing Image Image Data Peinter Host After image processing of the image data by CS-3/CS-1 based on "processing data" and "output data" for each output device, "patient data" is added and the image data output to externally-connected devices.

14 Image Reading (1-to-1 Connection) In the most basic system where one CS-3/CS-1 unit is connected to one REGIUS 190 unit (1-to1 Connection), the CS-3/CS-1 functions as a dedicated controller. While a 1-to-1 connection system can be connected to a multi-pair network, only the REGIUS 190 unit paired in 1-to-1 connection to the CS-3/CS-1 unit can be used for image reading. 1-to-1 Connection 1-to-1 Connection 1-to-1 Connection CS-3/CS-1 #1 CS-3/CS-1 #2 CS-3/CS-1 #3 RIS/IDS Printer, Host REGIUS 190 #1 REGIUS 190 #2 REGIUS 190 #3 Image read Network Image Reading (n-to-m Connection) In a system where multiple CS-3/CS-1 units and multiple REGIUS 190 units are connected in n-to-m configuration on one network, the REGIUS 190 units can be shared by any of the CS-3/CS-1 units. In the n-to-m connection configuration, any of the CS-3/CS-1 units can use all of the REGIUS 190 units for image reading. JM CS-3/CS-1 #1 CS-3/CS-1 #2 Printer, Host REGIUS 190 #1 REGIUS 190 #2 REGIUS 190 #3 Network

15 When connected to CS-2 From Image Reading to Image Data Storage Image Processing Parameter Exposed Cassette Setting Process Parameter QA Value Exam Tag Gradation Processing Display CS-2 Operation Unit Read REGIUS 190 CS-2 or RIS/IDS Input ID Info. ID Info. Process Parameter LUT Save To connected devices Output D I C O M Image Data Image Data Harddisk The image data read to REGIUS MODEL 190 will be displayed on CS-2 after undergoing image processing according to "processing data." Additionally, "patient data" and "processing data" are added to this image data and the resulting data will be stored as image data for one patient on the hard disk in the CS-2 control unit. Transfer of Image Data When image output is requested, the image data stored on the hard disk is output to the host and other externally-connected devices. The movement in CS-2 when data is transferred is shown below. Patient Data Image Process Parameter From Cassette Image Storage Processing Image Image Data Peinter Host After image processing of the image data by CS-2 based on "processing data" and "output data" for each output device, "patient data" is added and the image data output to externally-connected devices.

16 Image Reading (1-to-1 Connection) In the most basic system where one CS-2 unit is connected to one REGIUS 190 unit (1-to1 Connection), the CS-2 functions as a dedicated controller. While a 1-to-1 connection system can be connected to a multi-pair network, only the REGIUS 190 unit paired in 1-to-1 connection to the CS-2 unit can be used for image reading. 1-to-1 Connection 1-to-1 Connection 1-to-1 Connection CS-2 #1 CS-2 #2 CS-2 #3 External patient / Examination DB Printer, Viewer/Server REGIUS 190 #1 REGIUS 190 #2 REGIUS 190 #3 Image read Network Image Reading (n-to-m Connection) In a system where multiple CS-2 units and multiple REGIUS 190 units are connected in n-to-m configuration on one network, the REGIUS 190 units can be shared by any of the CS-2 units. In the n-to-m connection configuration, any of the CS-2 units can use all of the REGIUS 190 units for image reading. n-to-m Connection CS-2 #1 CS-2 #2 External patient / Examination DB Printer, Viewer/Server REGIUS 190 #1 REGIUS 190 #2 Image read (from any of the REGIUS units) Network

17 3 Installation Overview 3.1 Installation Conditions The place where the system is scheduled to be installed must satisfy all the following conditions. Place of Installation - There must be no water or floor wax on the floor. - The location must not be exposed to direct sunlight. <IMPORTANT> Exposure of the insertion slot to sunlight may produce reduced levels of barcode reader performance. - The location must be free of potential adverse effects to the system caused by atmospheric pressure, excesses of temperature or humidity, drafts, dust, salt in the air, inflammable gases or sulfur. - The floor of the location must be level and pose no risk of vibration or shock (including during transportation) - Where is not on the OA floor or the bit for electrical piping. <IMPORTANT> When the caster or adjuster foot of the device is placed on these surfaces, artifact such as streak may appear on the image. - Locations where chemicals are stored must be avoided. - The location must be free of gaseous emissions. - The location must be remote from potential sources of noise. - The location must pose no risk of passing personnel tripping over cables connected to the system. - The location must pose no risk of air inlets and outlets being blocked. Installation Space The location where the system is scheduled to be installed must provide the space specified below. The dimensions shown in parentheses indicate space necessary for installation and maintenance work. 100(600)mm or more 150(600)mm or more 100(600)mm or more Back 700mm or more Front

18 Route of Conveyance The route between the incoming point to the place of installation must be checked for any steps or steep ramps that may cause exposure of the equipment to shock. Additionally, any doorways through the equipment will pass must be checked to ensure sufficient clearance. Dimensions and Weight of the Machine Width : 580 mm Depth : 580 mm Height : 1230 mm Weight: Approx. 170 kg

19 3.2 Example of Installation A typical example of a system installation of REGIUS 190 is shown below. Basic system with one REGIUS 190 unit and one Console unit connected (1-to-1 connection). External Device Ethernet Cable Ethernet Hub (100base or 1000base) Console REGIUS 190

20 3.3 System Example An example of the REGIUS 190 system is shown below. When connected to CS-3/CS-1 n-to-m Connection (Maximum of 4 Units) This system comprises a maximum of four REGIUS 190 and CS-3/CS-1 units in total. CS-3/CS-1 (#1) is used as JM. The same configuration applies to a system comprising three CS-3/CS-1 units with one REGIUS 190 unit and one CS-3/CS-1 unit with three REGIUS 190 units. CS-3/CS-1 #1(Internal JM : ON) REGIUS 190 #1 Hub External Device CS-3/CS-1 #2(Internal JM : OFF) REGIUS 190 #2 n-to-m Connection (Minimum of 5 Units) This system comprises a minimum of five CS-3/CS-1 and REGIUS 190 units in total and requires an external JM. External JM-1 REGIUS 190 #1 CS-3/CS-1 #1 (Internal JM : OFF) Hub REGIUS 190 #2 CS-3/CS-1 #2 (Internal JM : OFF) REGIUS 190 #3 External Device

21 When connected to CS-2 n-to-m Connection This system comprises a maximum of four REGIUS 190 and CS-2 units in total. CS-2 (#1) is used as JM. The same configuration applies to a system comprising three CS-2 units with one REGIUS 190 unit and two CS-2 unit with two REGIUS 190 units. (maximum two REGIUS 190s can be connected) CS-2 #1(Internal JM : ON) REGIUS 190 #1 Hub External Device CS-2 #2(Internal JM : OFF) REGIUS 190 #2

22 4 Connections Overview 4.1 Diagram of Connections Connections for a 1-to-1 basic system are shown below. (The * indicates n-to-m connection.) REGIUS Power Cable AC100V * Ethernet Hub (10Base-T/100Base-TX/1000Base-T) or REGIUS Ethernet Cable (Supplied by sales) Ethernet Hub (10Base-T/100Base-TX/1000Base-T) RIS/IDS External patient /Examination DB Console External Device

23 4.2 List of Cables 1 Power Supply Cable (Accessory) REGIUS 190 Length : 3m Cable Diameter : 10mm AC100V App. 25mm App. 25mm No. of Pins : 3 2 Ethernet Calbe category 5 or higher (5e or higher is the must for 1000Base) <Supplied by Sales> REGIUS 190 Ethernet Hub (10base-T/100base-TX/1000base-T)

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