Product Specification

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1 FLXIS Fluoro 23cm 1k 2 IITV Subsystem Product Specification Document No Version 1.2

2 Manufacturer: Argus Imaging B.V. Jan Campertstraat 15, Building W 6416 SG, Heerlen The Netherlands Copyright Argus Imaging B.V. All rights reserved. No part of this book may be reproduced in any form, by print, photoprint, microfilm or any other means without the written permission from Argus Imaging B.V.

3 Table of Contents CHAPTER 1 General Description CHAPTER 2 Functionality CHAPTER 3 Architecture & Interfaces Product Architecture External Subsystem Interfaces CHAPTER 4 Performance Data CHAPTER 5 Configuration Components Mechanical Data CHAPTER 6 Standards CHAPTER 7 Maximum Ratings Environmental Conditions Reference Conditions CHAPTER 8 Spare Parts CHAPTER 9 Revision History FLXIS Fluoro 23 cm 1k 2 II TV Subsystem 1.2 Product Specification i

4 FLXIS Fluoro 23cm 1k 2 II TV Subsystem ii Product Specification 1.2

5 General Description CHAPTER 1 GENERAL DESCRIPTION The FLXIS Fluoro Image Intensifier/TV (IITV) products consist of a highly integrated II/camera/Image Processing(IP) subsystem with compact design. It is easy to integrate into system environments due to its flexible interfacing concept with respect to subsystem control. FLXIS Fluoro provides an image detection solution for medical X-ray systems that operate mainly in the fluoroscopy domain. The camera, camera optics and Image Intensifier deliver high performance imaging results. This is realized by the use of state of the art imaging technology and optics designed for medical imaging purposes. Image quality is further improved by using the (optional) on-board image processing. The on-board image processing is available in multiple flavors supporting the specific imaging application purposes of the customer's X-ray system. The combination of a sensor with high dynamic range and the noise reduction inside FLXIS image processing allows to create an image noise perception known from Vidicon / Saticon imaging tubes. In addition, high image sharpness will remain due to the use of solid state sensor technology. The noise reduction features a motion detection method which is pixel based instead of image frame based. Non-moving objects will have optimal noise reduction even when there are moving parts within the same image. Combined with the 10 bits output resolution this results in an optimal image quality in medical imaging applications. FLXIS features built-in subsystem control. The subsystem control supports an application intuitive control interface between X-ray system and IITV subsystem. It also assures optimal tuning of all components in the imaging chain based on man-independent and fully automated parameter calibrations. As system integrator you can now build your applications without requiring extensive knowledge of the subsystem's implementation. Automatic calibrations further greatly reduce installation and maintenance down time and it assures reproducible image quality and dose levels over years. The subsystem control concept comprises years of experience in medical imaging and now allows you to obtain optimal imaging performance in a simple way without requiring extensive knowledge of the fundamental imaging concepts in Image Intensifier/TV detection chains. The unit supports two methods for mounting to the geometry: at the front ring at the entrance side of the container or at the lateral side. All the components in FLXIS Image Intensifier/TV have been designed for use in medical imaging systems FLXIS Fluoro 23 cm 1k 2 II TV Subsystem 1.2 Product Specification 1

6 General Description FLXIS Fluoro 23cm 1k 2 II TV Subsystem Product Specification 1.2

7 Functionality CHAPTER 2 FUNCTIONALITY Feature Supported Remark 1 Anti-scatter grid (60 lp/cm) Option 2 12 bit 1k 2 30fps fluoro camera with automatic offset calibration 3 Sensitivity regulation via motorized iris 4 Doserate regulation signal (ABC) based on video signal measurements in a circular measuring field (60%). Includes white clipping and measuring field area correction feature. 1 5 II zooming (23 cm / 17 cm / 14 cm) 6 Synchronization: slave or master (with programmable frame speed) 7 Analog video output 1280x Hz/76Hz progressive (SXGA) 8 Image processing packages Standard: Last Image Hold (LIH), Automatic Gain Control (AGC), white clipping, white compression, graphic overlay Fluoroscopy package: edge enhancement, flip horizontal/vertical, noise reduction with motion detection & image invert Surgery package: Fluoroscopy package + electronic rotation (1º resolution) Plus package: (on top of Fluoroscopy package or Surgery package): contrast/brightness control, zoom/pan, memory for storing 25 images (grab LIH, grab from run), reviewing images (adjustable IP settings) 9 Extra IP options: extended memory option (125 images), vascular package (subtract, trace, gain, offset, pixelshift) 10 Extra Interfacing options: remote control user interface, direct control user interface, RS-644 digital video interface to PC, DVI (1280x1024) digital video interface to monitor, dual monitor output (live and reference) both on analog and DVI output 11 Automatic calibrations: II focusing, subsystem sensitivity Semi-automatic calibrations: II diameter Option Option Option Option Option Select package(s). Depends on the selected IP package. See Chapter 3 for specific details. Depends on the selected IP package. 1 Measuring field diameter is 60% of image diameter. Measuring field-area corrections allow to compensate for the impact of lead shutters in the measuring field, resulting in improved image quality FLXIS Fluoro 23 cm 1k 2 II TV Subsystem 1.2 Product Specification 3

8 Functionality REMARKS: 1. Sensitivity regulation is realized via a motorized iris. Via commands at the control interface the subsystem can automatically adapt to a wide range of X-ray dose to ensure optimal sensor light conditions for optimal image quality. 2. Calibrations are designed to yield man-independent calibration results. Some calibrations are fully automated, other calibrations are designed such that man-independent results are achieved when following the calibration guidelines as defined by Argus Imaging B.V. Man-independent calibration assures a high image quality level which remains constant over time and over products. FLXIS Fluoro 23cm 1k 2 II TV Subsystem Product Specification 1.2

9 Architecture & Interfaces CHAPTER 3 ARCHITECTURE & INTERFACES 3.1 Product Architecture The FLXIS Fluoro Image Intensifier/TV subsystem architecture is depicted in the figure below. X-ray IIA CLA CB IB video live (analog) video ref (analog) <optional> export <optional> FLXIS signal interfaces power (24V DC) ABC sync: CTRL_I [in] CTRL_O [out] command control (RS-232 or CAN-open) digital video [1k2] <optional> FIGURE 3-1 FLXIS architecture overview (Fluoro 1k 2 ) FLX Explanation of terminology: Term Description Remark IIA Image Intensifier Assembly Includes Image Intensifier Tube, container, High-Tension power supply. CLA Camera Lens Assembly Includes camera with CCD sensor and compact camera optics with integrated iris. CB Control Board (Subsystem Controller) PCB for controlling IIA, CLA, and IB IB Interface Board All signal interfacing to the subsystem is handled via this board. The board may also provide image processing functionality (see packages). IIA, CLA, CB and IB are all integrated into a compact unit which needs to be mounted into the geometry (e.g. C-arm) FLXIS Fluoro 23 cm 1k 2 II TV Subsystem 1.2 Product Specification 5

10 Architecture & Interfaces The control interfaces (Command Control, Sync, ABC) to the system environment as depicted can be either integrated in a system environment or be adapted to a system environment via optional interface extension modules. These extension modules allow in an easy way to operate the subsystem via hard wiredcontrol lines (such as footswitch signal, II-format zoom), or to provide control via a remote control module, or combinations thereof. Functional Interface FLXIS Command Control Interface FLXIS ABC interface FLXIS synchronization interface FLXIS power interface 3.2 External Subsystem Interfaces Purpose/ Description Controls the IITV subsystem on command basis for both clinical and field service applications. Implementation: Serial (RS-232), CAN link to PC, or Direct Control Module (digital signal lines) Analog signal for dose control purposes Digital signal(s) for image acquisition synchronization control Provide power to the IITV subsystem; 24 V DC FLXIS video interface Video output signals to the system 1 : Standard: analog: SXGA 75Hz) Optional: analog: - SXGA 76Hz), and/or - dual monitor output (ref. monitor) digital: - RS-644 (12 30fr/s max.), or - GigabitEthernet and/or - DVI (60Hz) with/without dual monitor 1 For details, see Video Interface Configurations specification. Mechanical/ Electrical Interface Mounting of the geometry part Control Interface extensions (optional) Direct Control Module Remote Control Module Purpose/ Description Mechanical interfacing to the stand Purpose/ Description Enables interfacing to existing hardware signal interfaces; interfacing to optional remote control module. Allows to control a limited set of parameters. NOTE: Detailed specification of the external subsystem interfaces is provided in separate documents. FLXIS Fluoro 23cm 1k 2 II TV Subsystem Product Specification 1.2

11 Performance Data CHAPTER 4 PERFORMANCE DATA FLXIS Fluoro 23cm 1k2 II TV Subsystem Min Typ Max Unit Nominal entrance field size 1 23 cm mode 230 mm Emission spectrum on II output screen (phosphor type) P20 DQE 2 23 cm mode 62 % Tolerance angular rotation on monitor Eccentricity subsystem on monitor mm S-distortion nominal 4 23 cm mode 0 3 * Integral distortion 5 23 cm mode 0 6 % Resolution -45/ cm mode 17 cm mode 14 cm mode lp/mm Contrast Ratio 7 15:1 Field size 8 23 cm mode mm Vignetting 9 23 cm mode % Camera dynamic range 10 1k x 1k 60 >60 db Camera framespeed progressive 1k x 1k 30 frames/ sec Camera integration time ms Digital video output bit depth 12 bits Camera Blemishes Sensor blemishes are digitally corrected Subsystem dose cm mode ngy/im Expected lifetime (2000 hr/yr usage) 10 Year *) With mu-metal entrance plate smaller than 0.5 degrees. Notes on performance data (see table before) 1 According to IEC , paragraph DQE of the II taking into account the input cover plate of the image intensifier housing, according to IEC , paragraph Eccentricity is the distance between centre of the image and centre of clean circle. 4 S-distortion measured at 0.05 mt ambient axial direction of the subsystem 5 According to IEC , paragraph Measured in image centre, with Funk38 resolution phantom, according to IEC FLXIS Fluoro 23 cm 1k 2 II TV Subsystem 1.2 Product Specification 7

12 Performance Data Notes on performance data (see table before) 7 Measured according to IEC (diameter of lead-pil 25mm) 8 Entrance size displayed on monitor, with SID = 100 cm, according to IEC , paragraph Vignetting defined as luminance at 90% of image diameter, compared to image center, according to IEC , paragraph Valid at 40 C sensor temperature and for 0 ms sensor integration time 11 For integration times longer than 40ms, but shorter than 800ms, some degradation of image quality performance may occur and drop below the specified value (camera blemishes for example) 12 The FLXIS subsystem will be able to realize an optimal video level working point within the entire specified dose range, without using AGC. Dose per image can be converted to doserate per second. Example 1: Continuous fluoro 25 frames/sec Doserate per second range = 25 * dose per image range, this is µgy/s µgy/s. Note: Max. integration time is 40ms per image. Example 2: Pulsed fluoro 12.5 frames/sec Doserate per second range = 12.5 * dose per image range, this is µgy/s µgy/s. Note: Max. integration time is 80ms per image. FLXIS Fluoro 23cm 1k 2 II TV Subsystem Product Specification 1.2

13 Configuration CHAPTER 5 CONFIGURATION 5.1 Components This product contains the following components: 23 cm HRC Image Intensifier Assembly Color aesthetic cover: mushroom 1 Includes: 23 cm HRC image intensifier insert 23 cm intensifier container 23 cm high-voltage power supply Camera Lens Assembly Includes: 1k2 camera with compact optics and motorized iris Control Board (CB) Interface Board (IB) Aesthetic EMC-closed cover on top of Image Intensifier container Color aesthetic cover: mushroom 1 Mounting plate Optional: Anti-scatter grid; SID: <customer dependent> Optional: RS-644 board Optional: DVI board 1. UN-D 1633, Mushroom 40383; F 12; Gn FLXIS Fluoro 23 cm 1k 2 II TV Subsystem 1.2 Product Specification 9

14 Configuration 5.2 Mechanical Data FLXIS Fluoro 23cm 1k2 IITV Subsystem Min Typ Max Unit Total subsystem length 455 mm Overall diameter 297 mm Net mass 29 kg Frontal mounting version Lateral mounting version FLXIS Fluoro 23cm 1k 2 II TV Subsystem Product Specification 1.2

15 Standards CHAPTER 6 STANDARDS The unit has been designed to meet the following standards: IEC IEC (RF Emissions according to Class B - 6dB) 1 IEC UL CSA C22.2 no M90 DHHS CFR title 21 subchapter J sections & CE classification Class II b rule 10 For other standards for other regions, certification occurs on system level. Argus Imaging B.V. can provide technical files to support this. 1. If the DVI option is used, RF Emissions are according to Class B FLXIS Fluoro 23 cm 1k 2 II TV Subsystem 1.2 Product Specification 11

16 Standards FLXIS Fluoro 23cm 1k 2 II TV Subsystem Product Specification 1.2

17 Maximum Ratings CHAPTER 7 MAXIMUM RATINGS 7.1 Environmental Conditions Operational* Temperature Humidity Air pressure Vibration Shock +10 C to +35 C for performance (40 C for safety) 20% to 80% (no condensation) 70kPa to 110kPa 10Hz to 150Hz, max. 2g with amplitude 0,15mm max. 10g, pulse time 6-10ms Transport Temperature -25 C to +70 C Humidity 5% to 95% Air pressure 70kPa to 110kPa Vibration 10Hz to 150Hz, max. 2 g with amplitude 0,15 mm Shock max. 10 g pulse time 6-10 ms *) These conditions comply with the IEC (68) recommendations. For further information please contact Dunlee (see address information on back of frontpage). 7.2 Reference Conditions The subsystem will be fit for use under the conditions described above. The reference conditions for the requirements defined in this specification are: Temperature 23 ºC Air pressure 100 kpa Relative humidity 50 % CAUTION OPERATION AND/OR STORAGE OF THE INTENSIFIER UNDER CONDITIONS CLOSE TO THE MAXIMUM LIMITS FOR EXTENDED TIME PERIODS MAY RESULT IN DETERIORATION IN THE PERFORMANCE FLXIS Fluoro 23 cm 1k 2 II TV Subsystem 1.2 Product Specification 13

18 Maximum Ratings FLXIS Fluoro 23cm 1k 2 II TV Subsystem Product Specification 1.2

19 Spare Parts CHAPTER 8 SPARE PARTS The following components can be ordered for field replacement. Item Description 23 cm HRC Image Intensifier insert 23 cm Image Intensifier container Color aesthetic cover: mushroom 1 Power unit for 23 cm HRC Image Intensifier Camera Lens Assembly Control Board (CB) Interface Board (IB) Entrance Shield Top and side cover Optional: Anti-scatter grid; SID: <customer dependent> Optional: RS-644 board Optional: DVI board 1) UN-D 1633, Mushroom 40383; F 12; Gn FLXIS Fluoro 23 cm 1k 2 II TV Subsystem 1.2 Product Specification 15

20 Spare Parts FLXIS Fluoro 23cm 1k 2 II TV Subsystem Product Specification 1.2

21 Revision History CHAPTER 9 REVISION HISTORY Date Version Remark April Provisional version Aug Provisional version Oct Final version March Update on version 1.0 April Chapter 6: Remark added about EMC. August Updated version June Updated version, changed OEM into re-starting with version 1.0 June Updated version June Updated version, change in manufacturers name & address FLXIS Fluoro 23 cm 1k 2 II TV Subsystem 1.2 Product Specification 17

22 Revision History FLXIS Fluoro 23cm 1k 2 II TV Subsystem Product Specification 1.2

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