MAN Revision 002. InSight Mini C-arm Imaging System Technical Reference Manual

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1 MAN Revision 002 InSight Mini C-arm Imaging System Technical Reference Manual

2 April 2007 The information contained in this Manual is confidential and proprietary to Hologic, Inc. This information is provided only to authorized representatives of Hologic s customers solely for the purpose of facilitating the use of Hologic s products. No information contained herein may be disclosed to any unauthorized person for any purpose whatsoever without the prior written consent of Hologic, Inc. The information in this document is subject to change without notice by Hologic, Inc. All rights reserved. InSight and Fluoroscan are trademarks of Hologic, Inc. Hologic and the Hologic logo are registered trademarks of Hologic, Inc. All other trademarks, registered trademarks, and product names used within this document are the property of their respective owners. The Hologic products described in this Manual are protected by at least some of the following U.S. Patents and foreign counterparts: 6,234,672; 6,236,712; PCT Intl. Application US98/25281 This manual originally drafted in the English language. Printed in the U.S.A. Hologic, Inc. 35 Crosby Drive Bedford, MA USA Tel: (781) Fax: (781) Service: (800) 321-HOLX ( ) User Support: (800) 321-HOLX ( Hologic Europe Hologic N.V. Leuvensesteenweg 250A 1800 Vilvoorde Belgium Tel: Fax:

3 Table of Contents Product Specifications...1 Power Requirements...1 Environmental Requirements...1 Weights/Dimensions...1 Space Requirements...1 X-Ray Specifications...2 Performance...2 Imaging Specifications...3 Laser Performance Specifications...3 Equipment Classification...4 Symbols...5 InSight Entrance Exposure Rate Data...6 Entrance Exposure Rate Data, Auto Mode...7 Scatter Radiation Survey...8 Insight System Labels...11 Manufacturer Serial Number Label...11 Patent Label...11 X-Ray System Warning Label...12 Electric Shock Warning Label...12 Class 1 Laser Label...12 Caution on Incline Label...12 Transport Label...12 X-Ray Controller Compliance Label...13 X-Ray Source Compliance Label...13 Collimator Compliance Label...14 Image Intensifier Compliance Label...14 C-Arm Compliance Label...15 AC Input Power Fuse Label...15 Accessory Fuse Label...15 Printer Fuse Label...16 Explosion Risk Label...16 Extremities Only Label...16 Field of View...16 Computer On/Standby Label...17 Ground Labels...17 Back Panel Labels...17 iii

4 iv InSight Technical Reference Manual

5 Product Specifications Power Requirements Parameter AC Input Voltage Wattage AC Input Frequency Computer System Backup Time Value Nominal 100/120/220/240 V Single Phase 750 watts maximum Nominal 50/60 Hz ~ 2 minutes with full charge Environmental Requirements Parameter Value Temperature Range (Operating) to +32 C (+60 to +90 F) Temperature Range (Storage) -20 to +50 C (-4 to +122 F) Relative Humidity (Operating) Relative Humidity (Storage and Transport) Atmospheric Pressure 20-80% non-condensing 20-85% non-condensing hpa ( mm Hg) Weights/Dimensions Height Width Depth Weight 65 in. (165.1 cm) 35 in. (88.9 cm) 35in. (88.9 cm) 500 pounds (227 kg) Space Requirements Required Floor Space: 5 ft. x 6.6 ft. (1.5 m x 2.0 m) Door Size Ground Clearance: 30 in. (88.9 cm) minimum in. (9.8 cm) minimum Floor Capacity lb/ft 2 (737.2 kg/m 2 ) Page 1 of 17

6 X-Ray Specifications Source - Image receptor distance 44 cm (17.5") X-ray source X-ray tube window Beam filtration Focal spot Field of View Rated peak tube potential Tube kvp range Tube current range Tolerance Maximun Duty cycle at 75 kvp/0.100 ma Grounded tungsten anode X-ray tube with custom designed high voltage generator " (0.127mm) Beryllium Stainless steel with aluminum equivalence 2.5mm mm 7.5 watts Operator selectable collimation of 4" or 6" diameter (10.16 cm or cm) FOV at the plane of the image intensifier 75 kvp 40 to 75 kvp to ma kvp ± 5% of displayed value ma ± 8% ma of displayed value ma ± 5% >0.035 ma of displayed value 50% Performance Parameter Acquisition Frame Rate Value Non-cine recording 30 FPS Cine recording 25 FPS Fluoroscopic Time Alarm Range 15 seconds 5 minutes, adjustable in 15 second increments (default is 5 minutes) Image Storage Capacity Cine Loop Capacity Laser Alignment Guide Timeout 4000 Images (maximum) 10 minutes maximum 20 seconds Page 2 of 17

7 Imaging Specifications Image intensifier C-arm dimensions Image processing Video system Resolution (using Nuclear Associates test tool , located at the minimum SSD in normal (6") mode) Contrast (using Nuclear Associates test tool , located at the surface of the image intensifier housing in normal (6") mode) High sensitivity Cesium Iodide Source to detector distance: 17.5" (44 cm) Free space: 14" (36 cm) Depth of arc = 14" (36 cm) Digital, with 2 to 8 frames of video averaging and last frame freeze 21" (53 cm) LCD touch screen monitor Solid state video camera DVI-I output 7.0 lp/mm, minimum Must resolve, at minimum, 30# mesh At least 3 of 4 low contrast masses (2,4,6,8 mm) visible Low contrast inserts in both monitor adjustment squares visible Laser Performance Specifications Parameter Condition Value Laser Power Device on IEC Class 1 Laser Wavelength Device on 650 nm Projected Line Width At image intensifier surface 0.05 ± 0.03 inches Projected Line Length Line Intersection Location Accuracy At center of image intensifier surface At center of image intensifier surface 7.00 ± 0.50 inches ± inches Auto-off delay Following turn on 20.0 ± 2.0 seconds Input Power Voltage N/A 5.00 ± 0.25 volts Input Power Current Device off 10 ma, max. Input Power Current Device on 100 ma, max. Page 3 of 17

8 Equipment Classification InSight is classified* as follows: Type of protection against electric shock CLASS 1 Degree of protection against electric shock TYPE B Laser per IEC CLASS 1 Degree of protection against harmful ingress of water Mode of operation IPXO Continuous Operation InSight is also classified* as: Equipment not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide. * Medical Electrical Equipment - UL Page 4 of 17

9 LBL Rev 001 InSight Technical Reference Manual Symbols The following symbols are found on the InSight system: R CSA listed device 0044 CE marked device Dangerous voltage Attention - Read the Caution or Warning statement that follows Type B equipment X-ray filtration Time delay fuse Protective ground Functional ground Equipotential ground USB connector X-ray on switch Laser on switch Print Store Rotate image Increase or decrease kv/ma Electrostatic sensitive device Dispose of electrical/electronic equipment properly Computer On/Standby switch Rear wheels free to move in all directions Rear wheels move forward and back only Rear wheels locked Cycle through the noise suppression settings Page 5 of 17

10 InSight Entrance Exposure Rate Data Typical entrance exposure rates, measured at a point in center of image intensifier, 2 cm above surface of the housing. kv ua ugy/s Page 6 of 17

11 kv ua ugy/s Entrance Exposure Rate Data, Auto Mode Typical entrance exposure rates with Auto kv/ma ON. 6" mode 8.9 ugy/s 4" mode 9.6 ugy/s Measured using RTI Barracuda dosimeter with Multi-Purpose Detector, positioned 2 cm above input surface of the image intensifier housing. There is no additional attenuation of the x-ray beam between the source and the dosimeter detector (open beam). Page 7 of 17

12 Scatter Radiation Survey Table 1: Air Kerma (mg/h) Rate Parallel to Cathode - Anode Axis using ANSI Knee Phantom; 65 kvp/.088 Ma Distance (cm) mg/h mr/h mg/h mr/h mg/h mr/h mg/h mr/h mg/h mr/h N/A N/A N/A N/A Table 2: Air Kerma (mg/h) Rate Parallel to Cathode - Anode Axis using ANSI Knee Phantom; 75 kvp/.100 ma Distance (cm) mg/h mr/h mg/h mr/h mg/h mr/h mg/h mr/h mg/h mr/h N/A N/A N/A N/A Table 3: Air Kerma (mg/h) Rate Perpendicular to Cathode - Anode Axis using ANSI Knee Phantom; 65 kvp/.088 ma Distance (cm) mg/h mr/h mg/h mr/h mg/h mr/h mg/h mr/h mg/h mr/h N/A N/A N/A N/A Page 8 of 17

13 Table 4: Air Kerma (mg/h) Rate Perpendicular to Cathode - Anode Axis using ANSI Knee Phantom; 75 kvp/.100 ma Distance (cm) mg/h mr/h mg/h mr/h mg/h mr/h mg/h mr/h mg/h mr/h N/A N/A N/A N/A Table 5: Air Kerma (mg/h) Rate Parallel to Cathode - Anode Axis using Anthropomorphic Hand Phantom; 50 kvp/.058 ma Distance (cm) mg/h mr/h mg/h mr/h mg/h mr/h mg/h mr/h mg/h mr/h N/A N/A N/A N/A Table 6: Air Kerma (mg/h) Rate Parallel to Cathode - Anode Axis using Anthropomorphic Hand Phantom; 75 kvp/.100 ma Distance (cm) mg/h mr/h mg/h mr/h mg/h mr/h mg/h mr/h mg/h mr/h N/A N/A N/A N/A Page 9 of 17

14 Table 7: Air Kerma (mg/h) Rate Perpendicular to Cathode - Anode Axis using Anthropomorphic Hand Phantom; 50 kvp/.058 ma Distance (cm) mg/h mr/h mg/h mr/h mg/h mr/h mg/h mr/h mg/h mr/h N/A N/A N/A N/A Table 8: Air Kerma (mg/h) Rate Perpendicular to Cathode - Anode Axis using Anthropomorphic Hand Phantom; 75 kvp/.100 ma Distance (cm) mg/h mr/h mg/h mr/h mg/h mr/h mg/h mr/h mg/h mr/h N/A N/A N/A N/A Page 10 of 17

15 Insight System Labels Manufacturer Serial Number Label The Manufacturer Serial Number Label is on the back of the base cabinet. System Model: InSight 2 Manufactured by: Hologic, Inc. 35 Crosby Drive Bedford, MA USA R 0044 Electrical rating: 100/120/220/240V 50/60 Hz, 750VA 50% Max Duty Cycle at 75kVp, 100uA LBL Rev. 001 Patent Label The Patent Label is on the back of the base cabinet. LBL Rev 001 Page 11 of 17

16 X-Ray System Warning Label The X-Ray System Warning Label is on the front of the base cabinet below the Computer On/ Standby switch. WARNING: This X-Ray unit may be dangerous to patient and operator unless safe exposure factors and operating instructions are observed REV 001 Electric Shock Warning Label The Electric Shock Warning Label is located near the fasteners for panels covering high voltage components. LBL REV 001 Class 1 Laser Label The Class 1 Laser Label is on the High Voltage Power Supply cover near the laser aperture. Class 1 Laser Product Complies with FDA performance standards for laser products except for deviations pursuant to Laser Notice number 50 dated July 26, LBL REV 002 Caution on Incline Label The Caution on Incline Label is on the back of the unit, above the handle. USE CAUTION WHEN MOVING SYSTEM ON INCLINE LBL Rev 001 Transport Label The Transport Label is on the back of the unit, above the handle. TRANSPORT UNIT WITH C-ARM LOCKED LBL Rev 002 Page 12 of 17

17 X-Ray Controller Compliance Label The X-Ray Controller Compliance Label is on the X-Ray Controller assembly and on the back of the base cabinet. This X-ray controller complies with DHHS rules 21 CFR Subchapter J applicable on date of manufacture. Manufactured by: Hologic, Inc. 35 Crosby Drive Bedford, MA USA Serial Number: Date of Manufacture: LBL Rev. 001 X-Ray Source Compliance Label The X-Ray Source Compliance Label is on the X-Ray source module and on the back of the base cabinet. Page 13 of 17

18 Collimator Compliance Label The Collimator Compliance Label is on the X-Ray source module (near the collimator assembly) and on the back of the base cabinet. This X-ray collimator complies with DHHS rules 21 CFR Subchapter J applicable on date of manufacture. Filtration: 2.5 mm Al 70 kvp Manufactured by: Hologic, Inc. 35 Crosby Drive Bedford, MA USA Date of Manufacture: LBL Rev. 002 Image Intensifier Compliance Label The Image Intensifier Compliance Label is on the back of the Radiological Imaging Unit cover. This Image Intensifier conforms to all applicable standards under Title 21 of the U.S. Code of Federal Regulations (21 CFR) Subchapter J. Manufactured by: Hologic, Inc. 35 Crosby Drive Bedford, MA USA Serial Number: Date of Manufacture: LBL Rev. 003 Page 14 of 17

19 C-Arm Compliance Label The C-Arm Compliance Label is on the back of the High Voltage Power Supply cover. This C-Arm Assembly conforms to all applicable standards under Title 21 of the U.S. Code of Federal Regulations (21 CFR) Subchapter J. Manufactured by: Hologic, Inc. 35 Crosby Drive Bedford, MA USA Serial Number: Date of Manufacture: LBL Rev. 001 AC Input Power Fuse Label The AC Input Power Fuse Label is on the back of the base cabinet near the AC power connector. Input Voltage Fuse Type Size V T10.0A/250V 5x20mm V T6.3A/250V 5x20mm (fuses are slow blow) LBL Rev. 002 Accessory Fuse Label The Accessory Fuse Label is on the back of the base cabinet near the accessory outlet. Accessory Outlet 120V 0.8A max Fuse Type: 5x20mm 1.0A 250V TD (Slow blow) LBL Rev. 001 Page 15 of 17

20 Printer Fuse Label The Printer Fuse Label is located at the back of the printer compartment near the printer outlet. Printer Outlet 120V Fuse Type: 5x20mm (Slow blow) 2.6A max 3.15A 250V TD LBL Rev. 001 Explosion Risk Label The Explosion Risk Label is located on the back of the base cabinet. Attention Risk of explosion. Do not use in the presence of flammable anesthetics. Risque d explosion. Ne pas employer en présence d anesthésiques inflammables. LBL Rev. 001 Extremities Only Label The Extremities Only Label is located on the back of the base cabinet. For examination of extremities only. LBL REV 001 Field of View Field of View is represented by raised circles on the underside of the High Voltage Power Supply. When the Field of View selection lever is positioned at the large circle (shown below) full field of view is selected. When the Field of View selection lever is positioned at the small circle reduced field of view is selected. Page 16 of 17

21 Computer On/Standby Label The Computer On/Standby Label is on the front of the base cabinet above the Computer On/ Standby switch. Ground Labels Each system grounding point, depending upon type of ground, has one of the Ground Labels shown below. Protective Ground Functional Ground Equipotential Ground Back Panel Labels The Ethernet and DVI labels are located in the middle of the system back panel below their respective connectors. ETHERNET DVI Page 17 of 17

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