Professional Documents
Culture Documents
R-F, Mobile
R-F, Mobile
UMDNS information
This Product Comparison covers the following device terms and product codes as listed in ECRIs Universal Medical Device Nomenclature System (UMDNS): Radiographic/Fluoroscopic Units, Mobile [11-758] Radiographic/Fluoroscopic Units, Mobile, Extremity [18-435]
Purpose
Mobile R/F units provide radiographic and fluoroscopic imaging in surgical, orthopedic, critical care, and emergency care procedures. They are used to image patients in radiolucent beds, stretchers, or tables when it is not feasible to transport the patient to the radiology department. The fluoroscopic feature allows real-time imaging, which permits quick diagnoses and
173302 424-010
5200 Butler Pike, Plymouth Meeting, PA 19462-1298, USA Telephone +1 (610) 825-6000 G Fax +1 (610) 834-1275
E-mail hpcs@ecri.org
Panning Motion
ay X-R be u T
Principles of operation
A mobile C-arm system usually consists of two wheeled units, one supporting the C-arm and the control console and the other supporting display monitors and image processing and recording devices. The Carm stand consists of a curved arm with an x-ray tube mounted on one end and an image intensifier on the other (see Fig. 1). The stand is constructed so that the C-arm can perform both linear and rotating motions for optimum positioning with respect to the patient. The x-ray tube typically consists of a cathode (spiral tungsten filament) and an anode (tungsten target) in an evacuated glass tube. The filament circuit provides the desired tube current, and the filament heats and begins to emit electrons. High voltage between the filament and target causes these electrons to speed toward the anode, striking it at the focal spot and producing x-rays. Generally, the greater the incoming power, the stronger and more intense the x-rays; applied current (mA) affects the number of electrons and thus the number of x-rays produced, whereas applied kilovoltage (kV) affects their energy and thus their penetrating power. Filters, usually made of aluminum, are placed in the path of the x-ray beam to absorb the less penetrating (soft) x-rays. The more penetrating (hard) x-rays pass through the filters, and the beam is then shaped by a set of collimators. Most C-arm units offer a choice of two focal spot sizes, depending on the imaging mode. In the fluoroscopic mode, focal spots typically range in size from 0.3 to 0.8 mm (0.08 to 0.5 mm for mini units); in the radiographic mode, they range from 0.3 to 1.8 mm. Focal spot size is important in image production because a smaller focal spot produces a clearer image. However, the anode-striking electrons produce intense heat, which can destroy the target anode. Heat intensity increases as focal spot size decreases, causing faster vaporization of the tungsten filament and shortening the life of the x-ray tube. Rotating anodes distribute the constant bombardment of electrons and resist pitting in a particular area. Thus, they can withstand the higher heat loads produced by smaller focal spots. The control console on the C-arm stand is mounted on top of the x-ray generator housing. From the console, the operator can control all the generator technique parameters, which determine the intensity and energy of the x-rays and therefore affect exposure and image quality. The mA settings on the generator control
e Fre ce Spa
Dep
th
Orbital Rotation
2003 ECRI. Duplication of this page by any means for any purpose is prohibited.
C204UN2B
camera to the output phosphor, but a few units transfer the image through a fiberoptic coupling. The quoted size of the image intensifier refers to the diameter of the input phosphor and not to the diameter of the patient area that is imaged. Several suppliers offer dual-mode 23/15 cm (9/6 in) image intensifiers; some offer trimode 23/15/11 cm (9/6/4.5 in) image intensifiers. Dual-mode image intensifiers provide one normal and one magnified view, and trimode image intensifiers provide one normal view and two magnified views. Mini C-arms have very small input phosphors, typically 6 to 15 cm (2.5 to 6 in) in diameter, that may permit visualization of only a portion of three fingers simultaneously on one image. Magnified images require moving the extremity closer to the x-ray tube, increasing the level of radiation per unit volume. However, a smaller patient area is exposed, keeping total patient radiation exposure constant. To aid in applications when line power is not available, an optical magnifier can be used to view the output phosphor in place of an electronic monitor. All fluoroscopic imaging systems also incorporate an automatic brightness stabilization system that is designed to maintain a constant image brightness as the image intensifier is moved over various parts of the patient and as contrast material (e.g., barium) enters and exits the field of view. The image can be kept at a constant brightness in one of two ways: by varying kVp and mA to compensate for variations in patient and imaging conditions (automatic dose control) or by adjusting the automatic gain control on the video system. Continuous fluoroscopy for long periods of time delivers a significant amount of radiation to the patient. Pulsed fluoroscopy is a technique in which the x-ray
Reported problems
Because mobile C-arms can be used in almost any area of the hospital, efforts must be made to protect operators and bystanders from radiation exposure. Operators should wear shielding garments such as lead aprons, and, if possible, the C-arm should be used only where the exposure of others will be limited.
2003 ECRI. Duplication of this page by any means for any purpose is prohibited.
Purchase considerations
The C-arm gantry must have the proper dimensions to be used effectively and easily in the hospital. For instance, it must be deep enough to accommodate obese patients. Additionally, the lower portion of the C-arm must be low enough to fit underneath the hospitals beds and operating room tables. The television (TV) chain system, another important component, displays the output of an image intensifier on one or more TV monitors during fluoroscopic procedures. (See the Product Comparison titled FLUOROSCOPIC TELEVISION CHAINS.) Some suppliers offer a high-resolution system; however, such systems are rarely used and require more radiation. If a highresolution system is needed, it should preferably be
2003 ECRI. Duplication of this page by any means for any purpose is prohibited.
Stage of development
Digital memory has expanded the usefulness of mobile C-arms by increasing image-processing capabilities. This increased capability may allow more extensive procedures, such as angiography, to be performed at the patients bedside rather than requiring transport to a catheterization laboratory (Aliabadi et al. 1997). However, further study is required to ensure the safety of such procedures performed at the patients bedside, specifically with units modified for cardiac imaging.
Bibliography
Aliabadi D, Pica MC, McCullough PA, et al. Rapid bedside coronary angiography with a portable fluoroscopic imaging system. Cathet Cardiovasc Diagn 1997 Aug;41(4):449-55. Bieze J. Radiation exposure risks haunt interventionalists. Diagn Imaging 1993 Aug;15(8):68-71, 74, 79.
2003 ECRI. Duplication of this page by any means for any purpose is prohibited.
Radiographic equipment. 21 CFR 1020.31. 2001. Radiology devices. 21 CFR 892. 2002.
2003 ECRI. Duplication of this page by any means for any purpose is prohibited.
Supplier information
Apelem Apelem SA [194762] Parc Scientifique Georges Besse 175 allee Von Neumann F-30035 Nimes Cedex France Phone: 33 (466) 290907 Fax: 33 (466) 297123 E-mail: apelphil@hotmail.com Internet: http://www.apelem.com Direx Direx Medical Systems Ltd [156982] PO Box 4190 Petach Tikva IL-49120 Israel Phone: 972 (3) 9248095 Fax: 972 (3) 9248092 E-mail: webmaster@direx.co.il Internet: http://www.direx.co.il Direx Systems Corp [392289] 11 Mercer Rd Natick MA 01760-2414 Phone: (508) 651-0900, (888) 874-7837 Fax: (508) 651-8125 E-mail: promo@direxusa.com Internet: http://www.direx.co.il ELMSTech ELMSTech Inc [409550] 950 Jericho Tpke Westbury NY 11590 Phone: (516) 338-9888, (866) 356-7832 Fax: (516) 338-9889 E-mail: sales@elmstech.com Internet: http://www.elmstech.com GE Medical GE Medical Systems [102107] PO Box 414 Milwaukee WI 53201-0414 Phone: (262) 544-3011, (800) 643-6439 Fax: (262) 544-3384 Internet: http://www.gemedicalsystems.com
2003 ECRI. Duplication of this page by any means for any purpose is prohibited.
Gilardoni Gilardoni SpA [176853] via Arturo Gilardoni 1 I-23826 Mandello de Lario LC Italy Phone: 39 (0341) 705111 Fax: 39 (0341) 735046 E-mail: gx@gilardoni.it Internet: http://www.gilardoni.it
LISTEM Hologic/Fluoroscan Fluoroscan Imaging Systems Inc A Hologic Co [149333] 35 Crosby Dr Bedford MA 01730 Phone: (781) 999-7300, (800) 343-9729 Fax: (847) 564-5647 E-mail: sales@hologic.com Internet: http://www.hologic.com LISTEM Corp [392886] 414-1 Chongchon-2 dong Pupyong-gu Inchon Republic of Korea Phone: 82 (32) 5155511 Fax: 82 (32) 5129814 E-mail: obd@listem.co.kr Internet: http://www.listem.co.kr
2003 ECRI. Duplication of this page by any means for any purpose is prohibited.
PCK PCK Electronic Industry and Trade Co Ltd [277887] ASO 1 Org San Bol Orhan Isik Cad No 4 Sincan TR-06935 Ankara Turkey Phone: 90 (312) 2672046 Fax: 90 (312) 2670609 E-mail: intlsales@pckmed.com Internet: http://www.pckmed.com
Philips Philips Medical Systems Asia [188101] 30/Fl Hopewell Centre 17 Kennedy Road Wanchai Hong Kong SAR Peoples Republic of China Phone: 852 28215888 Fax: 852 25276727 E-mail: medical@philips.com Internet: http://www.medical.philips.com Philips Medical Systems North America [102120] 22100 Bothell Everett Hwy PO Box 3003 Bothell WA 98041-3003 Phone: (425) 487-7000, (800) 526-4963 Fax: (425) 485-6080 E-mail: medical@philips.com Internet: http://www.medical.philips.com Philips Medical Systems UK Ltd [415447] The Observatory Castlefield Road Reigate, Surrey RH2 0FY England Phone: 44 (1737) 230503 Fax: 44 (1737) 230501 E-mail: anita.littlechild@philips.com Internet: http://www.medical.philips.com
2003 ECRI. Duplication of this page by any means for any purpose is prohibited.
10
2003 ECRI. Duplication of this page by any means for any purpose is prohibited.
Note: The data in the charts derive from suppliers specifications and have not been verified through independent testing by ECRI or any other agency. Because test methods vary, different products specifications are not always comparable. Moreover, products and specifications are subject to frequent changes. ECRI is not responsible for the quality or validity of the information presented or for any adverse consequences of acting on such information.
When reading the charts, keep in mind that, unless otherwise noted, the list price does not reflect supplier discounts. And although we try to indicate which features and characteristics are standard and which are not, some may be optional, at additional cost. For those models whose prices were supplied to us in currencies other than U.S. dollars, we have also listed the conversion to U.S. dollars to facilitate comparison among models. However, keep in mind that exchange rates change often.
2003 ECRI. Duplication of this page by any means for any purpose is prohibited.
11
FDA CLEARANCE CE MARK (MDD) X-RAY TUBE ANODE Maximum output @ 120 VAC @ 220 VAC
No Yes Rotating 100 mA @ 120 kVp 100 mA @ 120 kVp (max 130 mA) 300,000 70,000
Heat capacity, HU Cooling, HU/min Focal spot size, mm Radiographic mode Fluoroscopic mode Tube power rating, kW @ 100 kVp X-RAY GENERATOR TYPE Power rating, kW @ 100 kVp Radiographic mode kV range mA range mAs range AEC Exposure time, sec Fluoroscopic mode kV range mA range Pulsed fluoroscopy Pulses per sec
300,000 70,000
40,000 17,000
NA NA 1.4 NA
Not specified
15
2 (300 W)
NA NA NA NA NA
kVp Yes
kVp Yes
kVp Yes
kVp and mA No
Not specified
23/16/12 (9/6.3/ 4.7), 17/11 (7/4.3), 16 (6.3) 44 (17), dual monitors, image rotation 24 x 30 cm
23 (9)
This is the first of three pages covering the above model(s). These specifications continue onto the next two pages.
12
2003 ECRI. Duplication of this page by any means for any purpose is prohibited.
Digital memory, optional VCR, hard disk 1, 2, 5, 10 (D-RAM); 10,000 (hard disk); 10,000 (DSA)
Digital memory, optional VCR, hard disk (48 + LIH) LIH, LIH + 4, LIH + 48
Hard disk
Yes
11
512 x 512 x 8
512 x 512 x 8
1024 x 1024 x 12
Not specified
C-ARM Free space, cm (in) Depth, cm (in) Orbital rotation, Horizontal travel, cm (in) Vertical travel, cm (in) Panning motion, Pivot rotation, Reverse position POWER REQUIREMENTS
75.7 (30.8), 9"; 84 (33.1), 7" 66 (26), 9"; 68.6 (27), 7" 115
75.3 (29.6); 68.5 (27) for 12" I.I. 64 (25.2); 65 (25.6) for 12" I.I. 115
130
Yes
20 (7.9)
22 (8.7)
20 (7.9)
None
55 (21.7) 10 180 No 115/230 10% VAC, 50/60 Hz, 7.3 kVA max 200 x 81 x 175 (78.7 x 31.9 x 68.9)
None
None
This is the second of three pages covering the above model(s). These specifications continue onto the next page.
2003 ECRI. Duplication of this page by any means for any purpose is prohibited.
13
4 days 1995 NA Not specified Not specified Hard disk, DSA and max-op roadmapping, 100 Hz flicker-free monitors, laser centering, dosimeter
2 days 1993 NA Not specified Not specified 100 Hz flicker-free monitors, laser centering, dosimeter
Yes 1992 Not specified 1,300 January to December Last-image hold, 4,000-image archive, mobile unit, fixed unit
OTHER SPECIFICATIONS
None specified.
14
2003 ECRI. Duplication of this page by any means for any purpose is prohibited.
FDA CLEARANCE CE MARK (MDD) X-RAY TUBE ANODE Maximum output @ 120 VAC @ 220 VAC
Heat capacity, HU Cooling, HU/min Focal spot size, mm Radiographic mode Fluoroscopic mode Tube power rating, kW @ 100 kVp X-RAY GENERATOR TYPE Power rating, kW @ 100 kVp Radiographic mode kV range mA range mAs range AEC Exposure time, sec Fluoroscopic mode kV range mA range Pulsed fluoroscopy Pulses per sec
300,000 60,000
76,000 19,800
300,000 70,000
300,000 70,000
15
50-120 Up to 75 1-300 No 0.1-4, automatic computer control 40-120 0.2-10; 1-20, HLF Yes 1, 2, 4, or 8; 15 or 30 up to 150 mA (cardiac mode) kVp, mA, camera gain Yes
50-120 Up to 75 1-300 No 0.1-4, automatic computer control 40-120 0.2-10; 1-20, HLF Yes 1, 2, 4, or 8; 15 or 30 up to 150 mA (cardiac mode) kVp, mA, camera gain Yes
23/17/15 (9/7/6); 30/23/15 (12/9/6) optional 43.2 (17), dual; optional rotating 18 x 24 cm (7.1 x 9.4 in)
23/15 (9/6)
This is the first of three pages covering the above model(s). These specifications continue onto the next two pages.
2003 ECRI. Duplication of this page by any means for any purpose is prohibited.
15
Digital memory
Floppy disk, hard disk, optional SVHS VCR 1,000; 8,000; 36,000
PCMCIA drive, digital memory, hard & floppy disks, VCR 1-400 static (hard disk); 1-9,000 dynamic @ 15 fps real time
PCMCIA drive, digital memory, hard & floppy disks, VCR 1-400 static; 1-18,000 dynamic @ 30 fps real time
10,000
752 x 582 x 10 (optional 1 K x 1 K) Yes Yes Yes Optional paper, film printer, multiformat camera, laser imager, video printer 78 (30.7) 76.2 (30)
680 x 512 x 10
1000 x 1000 x 16
1000 x 1000 x 16
Yes Yes Yes Integrated film/ paper onboard printer, thermal printers * 78.7 (31) 66 (26) standard C (9" I.I.) ** 115 standard and medium C, 148 super 20.3 (8)
Yes Yes Yes Integrated film/ paper onboard printer, thermal printers 78.7 (31) 66 (26) standard C (9" I.I.) 115 standard and medium C, 148 super 20.3 (8)
C-ARM Free space, cm (in) Depth, cm (in) Orbital rotation, Horizontal travel, cm (in) Vertical travel, cm (in) Panning motion, Pivot rotation, Reverse position POWER REQUIREMENTS
20 (7.9)
45.7 (18) 10 360; 180/180; 180/90 flip-flop rotation Yes 120/240 VAC, 15/10 A
45.7 (18) 10 360; 180/180; 180/90 flip-flop rotation Yes 120/240 VAC, 15/10 A
Colons separate data on similar models of a device. * Also onboard instant film and paper printer. ** 71 cm (28") medium C (12" I.I.), 84 cm (33") super C (9" I.I.).
This is the second of three pages covering the above model(s). These specifications continue onto the next page.
16
2003 ECRI. Duplication of this page by any means for any purpose is prohibited.
3 days Not specified Not specified Not specified Not specified LCD monitor; touchscreen monitor; monitor with trolley with adjustable extension arm; handswitch for fluoroscopy or radiography; collision protector for image intensifier; laser targeting device; laser aimer; multiroom connection; remote control; 12" image intensifier CCD camera; upgradable image memory; real-time digital zoom, roam, edge enhancement, brightness & contrast, positive & negative image inversion, image rotation, DSA, roadmapping, radiation-free collimation; cineplay; annotation; remasking; digital image flip; snapshot; mosaic display; subpixel shifting; patient registration; anatomic programming; adjustable SID movement.
2 days 1998 Not specified Not specified January to December Handheld patient annotation keyboard, 44 cm (17") monitor, thermal printer, laser aimer/localizer, radiographic cassette holder, floppy disk
3-5 days 1999 Not specified Not specified January to December Zoom and roam, real-time edge enhancement, image annotation, DAP, laser localizer, IR remote, various configurations
3-5 days 1999 Not specified Not specified January to December Zoom and roam, real-time edge enhancement, image annotation, DAP, laser localizer, IR remote, various configurations, DSA, roadmap, bolus chasing
OTHER SPECIFICATIONS
Single-platform design; point-andshoot; anatomically specific ABS modes. Meets requirements of CISPR, CSA, EU, IEC, ISO, JIS, MedGV, NFPA, and UL.
DAP; touchscreen operation and integrated footswitch for user interface and operation.
DAP; touchscreen operation and integrated footswitch for user interface and operation.
2003 ECRI. Duplication of this page by any means for any purpose is prohibited.
17
FDA CLEARANCE CE MARK (MDD) X-RAY TUBE ANODE Maximum output @ 120 VAC @ 220 VAC
Heat capacity, HU Cooling, HU/min Focal spot size, mm Radiographic mode Fluoroscopic mode Tube power rating, kW @ 100 kVp X-RAY GENERATOR TYPE Power rating, kW @ 100 kVp Radiographic mode kV range mA range mAs range AEC Exposure time, sec Fluoroscopic mode kV range mA range Pulsed fluoroscopy Pulses per sec
75,000 37,000
7,000 3,000
70,000 9,200
70,000 9,200
Not specified
3.3
3.3
40-110 Up to 20 80 No 0.1-4
NA NA NA NA NA
40-80 0.02-0.16 No NA
kVp, mA Yes
23/15 (9/6)
15/10 (6/4)
23/15 (9/6)
This is the first of three pages covering the above model(s). These specifications continue onto the next two pages.
18
2003 ECRI. Duplication of this page by any means for any purpose is prohibited.
PCMCIA drive, hard disk, floppy disk, optional SVHS VCR 63, 400
PCMCIA drive, digital memory, hard disk, floppy disk * 18 CP, 400 HP
1000 x 1000 x 16
1000 x 1000 x 16
576 x 576 x 12
576 x 576 x 12
Yes Yes Yes Integrated film/ paper onboard printer, thermal printers 79.8 (31.4) 66 (26)
Yes Yes Yes Optional multiformat camera, video printer, thermal paper ** 70.1 (27.6) 58.4 (23)
Yes Yes Yes Optional multiformat camera, video printer, thermal paper ** 70.1 (27.6) 58.4 (23)
C-ARM Free space, cm (in) Depth, cm (in) Orbital rotation, Horizontal travel, cm (in) Vertical travel, cm (in) Panning motion, Pivot rotation, Reverse position POWER REQUIREMENTS
35 (13.8) 45 (17.7)
135
115
115 20.3 (8) 47.5 (18.7) 12 +290/-120 Yes 100/240 VAC, 50/60 Hz, 15 A
115 20.3 (8) 47.5 (18.7) 12 +290/-120 Yes 100/240 VAC, 50/60 Hz, 15 A
20.3 (8)
NA
70 (27)
230
Colons separate data on similar models of a device. * SVHS VCR optional. ** Also interface for external hard-copy device.
This is the second of three pages covering the above model(s). These specifications continue onto the next page.
2003 ECRI. Duplication of this page by any means for any purpose is prohibited.
19
3-5 days 2001 Not specified Not specified January to December Zoom and roam, realtime edge enhancement, image annotation, DAP, laser localizer, IR remote
1 day 2001 Not specified Not specified January to December Handswitch; DICOM 3.0; DDPI; Sony 980, 960, 890 thermal printers; removable archive kit; lightweight protective apron; dust cover; sterile drape combo pack; disposable I.I. guards; friction-adjustment kit
1 day on-site 1999 100 300 January to December Digital disk storage, edge enhancement, peak opacification, roadmapping, noise reduction, dosemonitoring device, laser alignment tool, digital subtraction
1 day on-site 1999 100 300 January to December Digital disk storage, edge enhancement, peak opacification, roadmapping, noise reduction, dosemonitoring device, laser alignment tool, digital subtraction
OTHER SPECIFICATIONS
DAP; touchscreen operation and integrated footswitch for user interface and operation.
ABS control tables. Meets requirements of CISPR, CSA, EU, IEC, ISO, JIS, and MedGV.
Cine review up to 30 fps; automatic brightness control; automatic brightness detection; automatic gain control.
20
2003 ECRI. Duplication of this page by any means for any purpose is prohibited.
FDA CLEARANCE CE MARK (MDD) X-RAY TUBE ANODE Maximum output @ 120 VAC @ 220 VAC
Heat capacity, HU Cooling, HU/min Focal spot size, mm Radiographic mode Fluoroscopic mode Tube power rating, kW @ 100 kVp X-RAY GENERATOR TYPE Power rating, kW @ 100 kVp Radiographic mode kV range mA range mAs range AEC Exposure time, sec Fluoroscopic mode kV range mA range Pulsed fluoroscopy Pulses per sec
800,000 60,000
665,000 60,000
6,480 10,700
6,480 10,700
2.8
2.8
0.0075
0.0075
NA NA NA NA NA
NA NA NA NA NA
40-75 0.02-0.1 NA NA
40-75 0.02-0.1 NA NA
kV, mA Yes
kV, mA Yes
17/12 (7/5) : 23/15/12 (9/6/4) : 30/23/15 (12/9/6) 43.2 (17), dual monitors 24 x 30 cm (10 x 12 in)
15 (6) : 17/12 (7/5) : 23/15/12 (9/6/4) 43.2 (17), dual monitors 24 x 30 cm (10 x 12 in)
10 (4)
This is the first of three pages covering the above model(s). These specifications continue onto the next two pages.
2003 ECRI. Duplication of this page by any means for any purpose is prohibited.
21
Digital memory, hard and floppy disks, optional VHS VCR 2,000-image HD; 4,000-image HD upgrade, 4 images/ diskette
576 x 576 x 8 or 1024 x 512 Yes Yes Yes Optional thermal printer
576 x 576 x 8
C-ARM Free space, cm (in) Depth, cm (in) Orbital rotation, Horizontal travel, cm (in) Vertical travel, cm (in) Panning motion, Pivot rotation, Reverse position POWER REQUIREMENTS
28 (11) 26 (10.2)
36 (14.2) 36 (14.2)
115
115
NA
120
21 (8.3)
21 (8.3)
147 (57.9)
119 (46.9)
81 (31.9)
58 (22.8)
320
Not specified
This is the second of three pages covering the above model(s). These specifications continue onto the next page.
22
2003 ECRI. Duplication of this page by any means for any purpose is prohibited.
Yes Not specified Not specified Not specified January to December None specified
Yes 1999 Not specified Not specified January to December None specified
1 day on-site 1998 Not specified Not specified October to September Professional-grade VHS; 15 x 23 cm (6 x 9 in) thermal printer, 15 x 23 cm (6 x 9 in) thermal paper/film; realtime histogramming; AutoMode ADR control; contrast expansion; edge enhancement; B/W reversal, mirroring; area of interest
OTHER SPECIFICATIONS
None specified.
None specified.
Real-time histogramming; AutoMode ADR control; contrast expansion; edge enhancement; B/W reversal and mirroring; usage audit; passwordprotected access; universal RS170 video output; sterile drapes.
Magnify, zoom, & roam; 4-image mosaic; RS170 composite video output; patented sterile field controls; 3-function footswitch (print/ x-ray/store);accesslimiting passwords (50 custom); laser aiming device; wireless remote-control pad; DICOM 3.0 Ethernet; sterile drapes; lightweight protective aprons; surgical drop-off style; comprehensive system use; patient billing: DICOM history/service logs.
2003 ECRI. Duplication of this page by any means for any purpose is prohibited.
23
FDA CLEARANCE CE MARK (MDD) X-RAY TUBE ANODE Maximum output @ 120 VAC @ 220 VAC
Heat capacity, HU Cooling, HU/min Focal spot size, mm Radiographic mode Fluoroscopic mode Tube power rating, kW @ 100 kVp X-RAY GENERATOR TYPE Power rating, kW @ 100 kVp Radiographic mode kV range mA range mAs range AEC Exposure time, sec Fluoroscopic mode kV range mA range Pulsed fluoroscopy Pulses per sec
6,480 10,700
76,000 19,800
45,000 46,000
76,000 19,800
0.0075
NA NA NA NA NA
40-75 0.02-0.1 NA NA
Colons separate data on similar models of a device. * Also dual histogram and multiregion control. ** Flicker-free portrait displays with right screen touch. *** Optional 18" TFT, flat panel.
This is the first of three pages covering the above model(s). These specifications continue onto the next two pages.
24
2003 ECRI. Duplication of this page by any means for any purpose is prohibited.
Digital memory, hard and floppy disks, optional VHS VCR * 2,000-image HD; 4 images/diskette; 4,000-image HD upgrade
Digital memory
Digital disk/memory, floppy disk, SVHS VCR, Jaz, Zip, CD-RW ** 500 up to 50,000 with 30 fps, dynamic image storage, optional dynamic array 1000 x 1000, 16-bit processing Yes Yes Yes Instant film/paper, Sony 960 and 980; Sony SVO 9500MD VCR; Codonics EP 1660 76.8 (30) 69 (27)
1-2
525 x 525 x 8
1287 x 512 x 10
C-ARM Free space, cm (in) Depth, cm (in) Orbital rotation, Horizontal travel, cm (in) Vertical travel, cm (in) Panning motion, Pivot rotation, Reverse position POWER REQUIREMENTS
36 (14.2) 36 (14.2)
76 (29.9) 68 (26.8)
76 (29.9) 68 (26.8)
120
115
135
119 (46.9)
22 (8.7)
22 (8.7)
22 (8.7)
58 (22.8)
43 (17)
43 (17)
43 (17)
320
20
20
20
Colons separate data on similar models of a device. * CD-R and CD-RW drive. ** Integrated DICOM 3.0 interface.
This is the second of three pages covering the above model(s). These specifications continue onto the next page.
2003 ECRI. Duplication of this page by any means for any purpose is prohibited.
25
1 day on-site 2003 Not specified Not specified October to September Professional-grade VHS; 15 x 23 cm (6 x 9 in) thermal printer, 15 x 23 cm (6 x 9 in) thermal paper/film; realtime histogramming; AutoMode ADR control; contrast expansion; edge enhancement; B/W reversal, mirroring; area of interest
Yes Not specified Not specified Not specified January to December Laser positioning device, dose measurement system
Yes Not specified Not specified Not specified January to December Laser positioning device, DSA, roadmapping, digital image rotation without radiation, Vision trac (virtual collimator without radiation)
Yes Not specified Not specified Not specified January to December Laser positioning device, real-time edge enhancement, zoom, patient annotation, window level, 4-on-1 print format, real-time subtraction, roadmapping, peak opacification, cine loop, dose measurement system, 5,000,000 HU storage and cooling system, Zip disk Frame averaging; field upgradable with all options. Complies with IEC 601-1. Meets requirements of TUV, UL, and VDE.
OTHER SPECIFICATIONS
Offers same specifications as Premier plus touch-sensitive display monitor; 185, 600, and 700 MB CD-R/CD-RW; custom settings for up to 20 physicians; video CD-ROM in-service tool.
Frame averaging; field upgradable with all options. Complies with IEC 601-1. Meets requirements of TUV, UL, and VDE.
Auto point ABS; Vision Center (touchscreen graphical user interface); field upgradable with all options. Complies with IEC 601-1. Meets requirements of TUV, UL, and VDE.
26
2003 ECRI. Duplication of this page by any means for any purpose is prohibited.
FDA CLEARANCE CE MARK (MDD) X-RAY TUBE ANODE Maximum output @ 120 VAC @ 220 VAC
Heat capacity, HU Cooling, HU/min Focal spot size, mm Radiographic mode Fluoroscopic mode Tube power rating, kW @ 100 kVp X-RAY GENERATOR TYPE Power rating, kW @ 100 kVp Radiographic mode kV range mA range mAs range AEC Exposure time, sec Fluoroscopic mode kV range mA range Pulsed fluoroscopy Pulses per sec
45,000 19,800
800,000 24,000
800,000 40,000
1.4 0.6 3.15 @ 110 kVp DC converter constant potential 3.15 @ 110 kVp
2.5
40-110 0.2-4 No NA
kVp, mA Yes
kV and mA No
23/15 (9/6)
23/17/16 (9/7/6)
23/17/16 (9/7/6)
This is the first of three pages covering the above model(s). These specifications continue onto the next two pages.
2003 ECRI. Duplication of this page by any means for any purpose is prohibited.
27
Digital memory
Digital memory
Digital memory
Digital memory
1 or 4
Not specified
1006 x 480 x 8 (60 Hz) display Yes Yes XA multiframe, RIS/HS, MPPS * Video media (dual) and paper printers; video and CD/DVD recorders 78 (30.7) 61 (24)
C-ARM Free space, cm (in) Depth, cm (in) Orbital rotation, Horizontal travel, cm (in) Vertical travel, cm (in) Panning motion, Pivot rotation, Reverse position POWER REQUIREMENTS
76 (29.9) 65 (25.6)
76 (29.9) 65 (25.6)
115
115
115
+90/-25
20 (7.9)
20 (7.9)
20 (7.9)
20 (7.9)
30 (11.8) motorized; 40 (15.7) optional 10 180 Yes 110 VAC, 60 Hz; 220 VAC, 50 Hz
30 (11.8) motorized; 40 (15.7) optional 10 180 Yes 110 VAC, 60 Hz; 220 VAC, 50 Hz
50 (19.7) 10 205, safety stop 150 Yes 110-240 10% VAC, 30/16 A
184 x 88 x 175 (73.6 x 35.2 x 68.9) w/23 cm (9") I.I., 187 x 88 x 181 (74.8 x 35.2 x 72.4) w/31 cm (12") I.I.
This is the second of three pages covering the above model(s). These specifications continue onto the next page.
28
2003 ECRI. Duplication of this page by any means for any purpose is prohibited.
Yes 1997 NA Not specified January to December Digital image rotation, laser positioning, radiation-free collimation, IR remote control, motorized pivot rotation, motorized orbital rotation
Yes 1997 NA Not specified January to December Digital image rotation, laser positioning, radiation-free collimation, IR remote control, motorized pivot rotation, motorized orbital rotation
Application; biomed negotiable 2001 Not specified Not specified January to December Extended memory storage, vascular laser functions with peak opacification, roadmapping, subtraction, extended vascular CO2 imaging, Smart Mask, extended processing, laser alignment tool, laser aiming light, 75 Hz triple-gun monitors Anatomically adaptive measuring field; real-time edge enhancement and movement detection; 16-image overview/ run overview; single-user interface; vascular footswitch; remote control.
OTHER SPECIFICATIONS
None specified.
2003 ECRI. Duplication of this page by any means for any purpose is prohibited.
29
FDA CLEARANCE CE MARK (MDD) X-RAY TUBE ANODE Maximum output @ 120 VAC @ 220 VAC
Yes Yes Rotating 20 mA @ 120 kVp 20 mA @ 120 kVp, 60 mA @ 100 kVp, 75 mA @ 110 kVp * 300,000/1,900,000 housing 70,000
Heat capacity, HU Cooling, HU/min Focal spot size, mm Radiographic mode Fluoroscopic mode Tube power rating, kW @ 100 kVp X-RAY GENERATOR TYPE Power rating, kW @ 100 kVp Radiographic mode kV range mA range mAs range AEC Exposure time, sec Fluoroscopic mode kV range mA range Pulsed fluoroscopy Pulses per sec
300,000 70,000
200,000 40,000
1.4 0.6 3.15 @ 110 kVp DC converter constant potential 3.15 @ 110 kVp
15
7.5
kV and mA No
kV and mA SharpShot
33/23/16/12 (13/9/7/4)
43.2 (17)
24 x 30 cm (10 x 12 in)
This is the first of three pages covering the above model(s). These specifications continue onto the next two pages.
30
2003 ECRI. Duplication of this page by any means for any purpose is prohibited.
Digital memory
Digital memory
Digital memory
1008 x 480 x 8 (60 Hz) display Yes Yes XA multiframe, RIS/HS, MPPS * Video media (dual) and paper printers; video and CD/DVD recorders 78 (30.7) 61 (24)
1006 x 480 x 8 display, 12-bit dedicated pipeline Yes Recursive filtering XA multiframe, RIS/HS, MPPS * Video media (dual) and paper printers; video and CD/DVD recorders 78 (30.7) 61 (24)
576 x 576
C-ARM Free space, cm (in) Depth, cm (in) Orbital rotation, Horizontal travel, cm (in) Vertical travel, cm (in) Panning motion, Pivot rotation, Reverse position POWER REQUIREMENTS
70 (27.6) 64 (25.2)
75 (29.5) 64 (25.2)
+90/-25
115
115
20 (7.9)
20 (7.9)
20 (7.9)
50 (19.7) 10 205, safety stop 150 Yes 110-240 10% VAC, 30/16 A
50 (19.7) 10 205 Yes 110-240 VAC; 15 A @ 120 VAC, 16 A @ 220 VAC 184 x 88 x 175 (73.6 x 35.2 x 70) w/23 cm (9") I.I., 187 x 88 x 181 (74.8 x 35.2 x 72.4) w/31 cm (12") I.I.
This is the second of three pages covering the above model(s). These specifications continue onto the next page.
2003 ECRI. Duplication of this page by any means for any purpose is prohibited.
31
Application; biomed negotiable 2001 Not specified Not specified January to December Extended memory storage, second monitor, processing, extended processing, laser alignment tool, laser aiming light, dose indicator, 75 Hz triplegun monitors, vascular functions
Application; biomed negotiable 2001 Not specified Not specified January to December Extended image memory, vascular functions including roadmapping, subtraction, peak, Smart Mask, CO2 imaging, extended processing, laser alignment tool, laser aiming light, remote control single-user interface, cardiac package, 75 Hz triplegun monitor Anatomically adaptive measuring field; image intensifier fiberoptically coupled to TV camera (CCD) with amorphous lens; real-time edge enhancement and movement detection; auto high-penetration low-dose technique; 16-image overview/run overview; vascular footswitch.
Not specified 2003 Not specified Not specified Not specified Keyboard for patient patient ID data, laser-beam centering, half-transparent collimator, variable (90-105 mm) SID
Not specified 1993 Not specified Not specified Not specified Half-transparent collimator, laserbeam centering device, variable (90-105 mm) SID
OTHER SPECIFICATIONS
Anatomically adaptive measuring field; image intensifier fiberoptically coupled to TV camera (CCD) with amorphous lens; 16-image overview.
Mobile DSA; PTCA; intraoperative angiography; digital disk storage; real-time subtraction; special procedures; motion artifact reduction; roadmapping; max peak opacification; noise reduction; laser-beam centering; 130 mA pulsed fluoroscopy. Meets requirements of IEC 601-1.
32
2003 ECRI. Duplication of this page by any means for any purpose is prohibited.
FDA CLEARANCE CE MARK (MDD) X-RAY TUBE ANODE Maximum output @ 120 VAC @ 220 VAC
Heat capacity, HU Cooling, HU/min Focal spot size, mm Radiographic mode Fluoroscopic mode Tube power rating, kW @ 100 kVp X-RAY GENERATOR TYPE Power rating, kW @ 100 kVp Radiographic mode kV range mA range mAs range AEC Exposure time, sec Fluoroscopic mode kV range mA range Pulsed fluoroscopy Pulses per sec
300,000 70,000
300,000 70,000
270,000 50,000
NA 0.3/0.5 20 High-frequency
15
15
20
1.4
NA NA NA NA NA
kVp, mA Yes
kVp, mA Yes
23/15 (9/6)
43.2 (17)
24 x 30 cm (10 x 12 in)
This is the first of three pages covering the above model(s). These specifications continue onto the next two pages.
2003 ECRI. Duplication of this page by any means for any purpose is prohibited.
33
Digital memory
Digital memory
5,000/10,000
900
512 x 512 or 1024 x 1024 Yes Yes Optional Optional camera, video printer, thermal printer
570 x 570, 1024 x 1024 Yes Yes Optional Optional video printer, thermal printer, laser printer, DICOM 3.0 75 (29.5) 64 (25.2)
512 x 444
512 x 444
Yes 0-32 frames Yes Paper, film, laser multiformat film, CODONICS, DICOM, 1,000-image disk 78 (30.7) 71.4 (28.1)
Yes 0-32 frames Yes Paper, film, laser multiformat film, CODONICS, DICOM, 1,000-image disk 78 (30.7) 73 (28.7)
C-ARM Free space, cm (in) Depth, cm (in) Orbital rotation, Horizontal travel, cm (in) Vertical travel, cm (in) Panning motion, Pivot rotation, Reverse position POWER REQUIREMENTS
75 (29.5) 64 (25.2)
135
135
190 (95)
130 (+90/-40)
20 (7.9)
20 (7.9)
20.3 (8)
20 (7.9)
165 x 80 x 164.8 (65 x 31.5 x 64.9), 212 x 80 x 181 (83.5 x 31.5 x 71.3)
This is the second of three pages covering the above model(s). These specifications continue onto the next page.
34
2003 ECRI. Duplication of this page by any means for any purpose is prohibited.
Not specified 2001 : 1992 Not specified Not specified Not specified Keyboard for patient ID data, laser-beam centering, half-transparent collimator, variable (90-105 mm) SID
Not specified 2001 Not specified Not specified Not specified None specified
3 days 1999 Not specified Not specified Not specified Digital cine mode up to 250 mA, cableless counterbalanced isocentric C-arm, DSA and roadmap standard
2 days (3 days DSA) 2001 (1996 Compact) Not specified Not specified Not specified Digital image rotation, electronic shutters on stored image, image collage, dose-area product display, auto window imaging, electromagnetic lock controls, 25 customizable user programs
OTHER SPECIFICATIONS
Mobile DSA; PTCA; intraoperative angiography; digital disk storage; real-time subtraction; special procedures; motion artifact reduction; roadmapping; max peak opacification; 130 mA pulsed fluoroscopy. Meets requirements of IEC 601-1.
Motorized with movements speed proportional; remote controlled by joystick or with dedicated panel on both sides; manual and motorized C-arm movement; safety clutches for all electric-powered movements; touchscreen-controlled x-ray parameters; 5 x-ray tube cooling fans to extend operational capabilities; 130 mA pulsed.
None specified.
None specified.
2003 ECRI. Duplication of this page by any means for any purpose is prohibited.
35
FDA CLEARANCE CE MARK (MDD) X-RAY TUBE ANODE Maximum output @ 120 VAC @ 220 VAC
Heat capacity, HU Cooling, HU/min Focal spot size, mm Radiographic mode Fluoroscopic mode Tube power rating, kW @ 100 kVp X-RAY GENERATOR TYPE Power rating, kW @ 100 kVp Radiographic mode kV range mA range mAs range AEC Exposure time, sec Fluoroscopic mode kV range mA range Pulsed fluoroscopy Pulses per sec
1.4
1.4
2.8
2.8
23/15 (9/6)
16/12 (6.3/4.7)
This is the first of three pages covering the above model(s). These specifications continue onto the next two pages.
36
2003 ECRI. Duplication of this page by any means for any purpose is prohibited.
Digital memory
Digital memory
900
900
512 x 444
512 x 444
576 x 576 x 8
576 x 576 x 8
Yes 0-32 frames Yes Paper, film, laser multiformat film, CODONICS, DICOM, 1,000-image disk 78 (30.7) 73 (28.7)
Yes 0-32 frames Yes Paper, film, laser multiformat film, CODONICS, DICOM, 1,000-image disk 78 (30.7) 73 (28.7)
C-ARM Free space, cm (in) Depth, cm (in) Orbital rotation, Horizontal travel, cm (in) Vertical travel, cm (in) Panning motion, Pivot rotation, Reverse position POWER REQUIREMENTS
115
115
20 (7.9)
20 (7.9)
This is the second of three pages covering the above model(s). These specifications continue onto the next page.
2003 ECRI. Duplication of this page by any means for any purpose is prohibited.
37
2 days (3 days DSA) 1998 : 1999 Not specified Not specified Not specified Digital image rotation, electronic shutters on stored image, image collage, dose-area product display, auto window imaging : Cableless isocentric design supports, 3-D feature for real-time intraoperative acquisition of 3-D data set (CT-like images) * None specified.
2 days (3 days DSA/ 3D) 2001 Not specified Not specified Not specified Digital image rotation, electronic shutters on stored image, image collage, dose-area product display, auto window imaging, cableless isocentric design supports
Not specified Not specified Not specified Not specified January to December Digital systems, cross-laser localizer, models of collimators, sterilized covers
Not specified Not specified Not specified Not specified January to December Digital systems, cross-laser localizer, models of collimators, sterilized covers
OTHER SPECIFICATIONS
3-D feature for real-time intraoperative acquisition of 3-D data set (CT-like images) before, during, or after OR procedures; instant review of 3-D and multiplanar reconstructions.
None specified.
None specified.
Colons separate data on similar models of a device. * Before, during, or after OR procedures; instant review of 3-D and multiplanar reconstructions.
38
2003 ECRI. Duplication of this page by any means for any purpose is prohibited.
FDA CLEARANCE CE MARK (MDD) X-RAY TUBE ANODE Maximum output @ 120 VAC @ 220 VAC
Heat capacity, HU Cooling, HU/min Focal spot size, mm Radiographic mode Fluoroscopic mode Tube power rating, kW @ 100 kVp X-RAY GENERATOR TYPE Power rating, kW @ 100 kVp Radiographic mode kV range mA range mAs range AEC Exposure time, sec Fluoroscopic mode kV range mA range Pulsed fluoroscopy Pulses per sec
76,000 19,800
200,000 33,000
2.8
2.8
2.8, 5
Not specified Not specified Not specified Not specified Not specified
Yes Yes
kV, mA Yes
23 (9)
23/15/11 (9/6/4.5), 17/13 (7/5), 15 (6) 43.2 (17), single or dual monitors 24 x 30 cm 10 x 24 in), or 18 x 24 cm (7 x 10 in)
This is the first of three pages covering the above model(s). These specifications continue onto the next two pages.
2003 ECRI. Duplication of this page by any means for any purpose is prohibited.
39
Digital memory
Digital memory
RAM
Digital memory
Digital imaging processor 100 Hz/48 frames on RAM and 20,000 frames on hard disk 576 x 576 x 8
576 x 576 x 8
576 x 576 x 8
750 x 576
Yes 2-16 Optional Video-copy printer, optional multiformat camera and DICOM interface 106 (41.7) Not specified
Yes Yes Optional (with DIP memory) Optional video/film/ thermal/laser printer, hard disk, CD-ROM * 79 (31.1) 70 (27.6)
C-ARM Free space, cm (in) Depth, cm (in) Orbital rotation, Horizontal travel, cm (in) Vertical travel, cm (in) Panning motion, Pivot rotation, Reverse position POWER REQUIREMENTS
115
115
Not specified
120
20 (7.9)
20 (7.9)
Not specified
22 (8.7)
Colons separate data on similar models of a device. * Video recorder or multiformat camera.
This is the second of three pages covering the above model(s). These specifications continue onto the next page.
40
2003 ECRI. Duplication of this page by any means for any purpose is prohibited.
Not specified Not specified Not specified Not specified January to December Digital systems, cross-laser localizer, models of collimators, sterilized covers
Not specified Not specified Not specified Not specified January to December Digital systems, cross-laser localizer, models of collimators, sterilized covers
Yes 1987 Not specified 200 January to December Hard-disk storage for up to 2,900 images
None 2003 NA Not specified January to December Laser targeting device, thermal printer, dosimeter w/printer, flickerfree TV chain, digital image processor, DICOM interfacing, CD-ROM (with DICOM), video recorder
OTHER SPECIFICATIONS
None specified.
None specified.
Meets requirements of EMC and EN 60601-1-2, 601-1, 601-2-7, 601-2-28, 62B (CO) 88, and 62B (CO) 108.
None specified.
2003 ECRI. Duplication of this page by any means for any purpose is prohibited.
41
FDA CLEARANCE CE MARK (MDD) X-RAY TUBE ANODE Maximum output @ 120 VAC @ 220 VAC
Heat capacity, HU Cooling, HU/min Focal spot size, mm Radiographic mode Fluoroscopic mode Tube power rating, kW @ 100 kVp X-RAY GENERATOR TYPE Power rating, kW @ 100 kVp Radiographic mode kV range mA range mAs range AEC Exposure time, sec Fluoroscopic mode kV range mA range Pulsed fluoroscopy Pulses per sec
40,000 17,000
200,000 33,000
40,000 17,000
300,000 65,000
2.8
2.8
10
kV, mA Yes
kVp, mA Yes
kVp, mA Yes
23/15/11 (9/6/4.5), 17/13 (7/5), 15 (6) 43.2 (17), single or dual monitors 24 x 30 cm 10 x 24 in), or 18 x 24 cm (7 x 10 in)
25/15/11 (9/6/4)
43.2 (17), dual monitors 24 x 30 cm (9.5 x 11.8 in), 35 x 35 cm (13.8 x 13.8 in)
This is the first of three pages covering the above model(s). These specifications continue onto the next two pages.
42
2003 ECRI. Duplication of this page by any means for any purpose is prohibited.
Digital memory
Digital memory
Digital memory
Digital imaging processor 100 Hz/48 frames on RAM and 20,000 frames on hard disk 576 x 576 x 8
80,000
576 x 576 x 10
576 x 576 x 10
512 x 512, optional 1024 x 1024 Yes Yes Yes Optional multiformat camera, video printer, thermal printer 78 (30.7) 50 (20.7)
Yes Yes Optional (with DIP memory) Optional video/film/ thermal/laser printer, hard disk, CD-ROM 79 (31.1) 70 (27.6)
C-ARM Free space, cm (in) Depth, cm (in) Orbital rotation, Horizontal travel, cm (in) Vertical travel, cm (in) Panning motion, Pivot rotation, Reverse position POWER REQUIREMENTS
74 (29.1), 9" I.I.; 82 (32.3), 7" I.I. 67 (26.4), 9" I.I.; 69 (27.2), 7" I.I. 120 (+90/-30)
74 (29.1), 9" I.I.; 82 (32.3), 7/6" I.I. 67 (26.4), 9" I.I.; 69 (27.2), 7/6" I.I. 120 (+90/-30)
120
125
22 (8.7)
22 (8.7)
22 (8.7)
21 (8.3)
This is the second of three pages covering the above model(s). These specifications continue onto the next page.
2003 ECRI. Duplication of this page by any means for any purpose is prohibited.
43
None 2003 NA Not specified January to December Laser targeting device, thermal printer, dosimeter w/printer, flickerfree TV chain, digital image processor, DICOM interfacing, CD-ROM (with DICOM), video recorder
Not specified Not specified Not specified Not specified Not specified None specified
Not specified Not specified Not specified Not specified Not specified None specified
2 days on-site 1997 Not specified Not specified January to December Healthcare department certified; quality system ISO 9001 certified. Meets requirements of IEC 60.601-1.
OTHER SPECIFICATIONS
None specified.
None specified.
None specified.
44
2003 ECRI. Duplication of this page by any means for any purpose is prohibited.