Technical Reference Manual
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InSight Mini C-arm Imaging System Technical Reference Manual
MAN-00668 Revision 002
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. ©
2006-2007 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 01730 USA Tel: (781) 999-7300 Fax: (781) 280-0669 Service: (800) 321-HOLX (321-4659) User Support: (800) 321-HOLX (321-4659 Hologic Europe Hologic N.V. Leuvensesteenweg 250A 1800 Vilvoorde Belgium Tel: 32.2.711.4680 Fax: 32.2.725.2087
InSight Technical Reference Manual
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
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InSight Technical Reference Manual
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InSight Technical Reference Manual
Product Specifications Power Requirements Parameter
Value
AC Input Voltage
Nominal 100/120/220/240 V Single Phase
Wattage
750 watts maximum
AC Input Frequency
Nominal 50/60 Hz
Computer System Backup Time
~ 2 minutes with full charge
Environmental Requirements Parameter
Value
Temperature Range (Operating)
+15.5° to +32° C (+60° to +90° F)
Temperature Range (Storage)
-20° to +50° C (-4° to +122° F)
Relative Humidity (Operating)
20 - 80% non-condensing
Relative Humidity (Storage and Transport)
20 - 85% non-condensing
Atmospheric Pressure
500 -1060 hPa (375 - 795 mm Hg)
Weights/Dimensions Height
65 in. (165.1 cm)
Width
35 in. (88.9 cm)
Depth
35in. (88.9 cm)
Weight
500 pounds (227 kg)
Space Requirements Required Floor Space:
5 ft. x 6.6 ft. (1.5 m x 2.0 m)
Door Size
30 in. (88.9 cm) minimum
Ground Clearance:
3.875 in. (9.8 cm) minimum
Floor Capacity
151.1 lb/ft2 (737.2 kg/m2)
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InSight Technical Reference Manual
X-Ray Specifications Source - Image receptor distance
44 cm (17.5")
X-ray source
Grounded tungsten anode X-ray tube with custom designed high voltage generator.
X-ray tube window
0.005" (0.127mm) Beryllium
Beam filtration
Stainless steel with aluminum equivalence ≥2.5mm
Focal spot
0.045 mm (0.0018") @ 7.5 watts
Field of View
Operator selectable collimation of 4" or 6" diameter (10.16 cm or 15.24 cm) FOV at the plane of the image intensifier
Rated peak tube potential
75 kVp
Tube kVp range
40 to 75 kVp
Tube current range
0.020 to 0.100 mA
Tolerance
kVp ± 5% of displayed value mA ± 8% ≤0.035 mA of displayed value mA ± 5% >0.035 mA of displayed value
Maximun Duty cycle at 75 kVp/0.100 mA
50%
Performance Parameter
Value
Acquisition Frame Rate
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
4000 Images (maximum)
Cine Loop Capacity
10 minutes maximum
Laser Alignment Guide Timeout
20 seconds
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InSight Technical Reference Manual
Imaging Specifications Image intensifier
High sensitivity Cesium Iodide
C-arm dimensions
Source to detector distance: 17.5" (44 cm) Free space: 14" (36 cm) Depth of arc = 14" (36 cm)
Image processing
Digital, with 2 to 8 frames of video averaging and last frame freeze
Video system
21" (53 cm) LCD touch screen monitor Solid state video camera DVI-I output
Resolution (using Nuclear Associates test tool 07-539, located at the minimum SSD in normal (6") mode)
7.0 lp/mm, minimum
Contrast (using Nuclear Associates test tool 07-647, located at the surface of the image intensifier housing in normal (6") mode)
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
At center of image intensifier surface
7.00 ± 0.50 inches
Line Intersection Location Accuracy
At center of image intensifier surface
± 0.125 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.
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InSight Technical Reference Manual
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-60825-1
CLASS 1
Degree of protection against harmful ingress of water
IPXO
Mode of operation
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 60601-1
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InSight Technical Reference Manual
Symbols The following symbols are found on the InSight system:
R
LBL-00270 Rev 001
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
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
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InSight Technical Reference Manual
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
43
30
3.22
44
34
3.86
45
38
4.65
46
42
5.47
47
44
6.18
48
46
6.81
49
52
8.05
50
56
9.14
51
58
9.98
52
60
10.87
53
62
11.70
54
64
12.69
55
66
13.61
56
68
14.71
57
70
15.64
58
72
16.77
59
74
17.85
60
76
19.08
61
78
20.22
62
80
21.51
63
82
22.75
64
84
24.05
65
86
25.36
66
88
26.77
67
90
28.20
68
92
29.61
69
94
31.32
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InSight Technical Reference Manual
kV
uA
uGy/s
70
96
32.73
71
99
34.73
72
100
35.84
73
100
36.70
74
100
37.70
75
100
38.41
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).
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InSight Technical Reference Manual
Scatter Radiation Survey Table 1: Air Kerma (mG/h) Rate Parallel to Cathode - Anode Axis using ANSI Knee Phantom; 65 kVp/ .088 Ma 45°
22.5°
0°
-22.5°
-45°
Distance (cm)
mG/h
mR/h
mG/h
mR/h
mG/h
mR/h
mG/h
mR/h
mG/h
mR/h
20
0.075
8.9
0.079
9.14
0.086
10.08
0.093
10.71
0.018
2.25
40
0.025
3.03
0.025
2.95
0.032
3.66
0.046
5.67
0.018
2.11
60
0.014
1.9
0.007
0.88
0.014
1.7
0.032
4.06
0.001
0.21
80
0.003
0.74
0.003
0.75
0.009
1.07
0.025
2.9
N/A
N/A
100
0.003
0.72
0.003
0.73
0.006
0.76
0.01
1.54
N/A
N/A
Table 2: Air Kerma (mG/h) Rate Parallel to Cathode - Anode Axis using ANSI Knee Phantom; 75 kVp/ .100 mA 45°
22.5°
0°
-22.5°
-45°
Distance (cm)
mG/h
mR/h
mG/h
mR/h
mG/h
mR/h
mG/h
mR/h
mG/h
mR/h
20
0.432
49.35
0.428
49.11
0.378
43.43
0.306
35.03
0.057
3.75
40
0.158
18.14
0.144
16.46
0.133
15.52
0.122
14.08
0.032
3.94
60
0.057
6.86
0.068
8.13
0.07
8.09
0.068
8.01
0.01
1.62
80
0.036
4.5
0.046
5.84
0.043
5.01
0.043
5.28
N/A
N/A
100
0.025
2.91
0.028
3.42
0.029
3.42
0.025
3.03
N/A
N/A
Table 3: Air Kerma (mG/h) Rate Perpendicular to Cathode - Anode Axis using ANSI Knee Phantom; 65 kVp/ .088 mA 45°
22.5°
0°
-22.5°
-45°
Distance (cm)
mG/h
mR/h
mG/h
mR/h
mG/h
mR/h
mG/h
mR/h
mG/h
mR/h
20
0.064
7.69
0.05
6.14
0.075
8.67
0.09
10.38
0.025
2.93
40
0.025
3.09
0.032
4.6
0.029
3.42
0.046
5.51
0.003
0.82
60
0.039
4.56
0.028
3.42
0.024
3.2
0.032
3.95
0.003
0.82
80
0.032
3.83
0.018
2.22
0.014
1.14
0.025
3.03
N/A
N/A
100
0.021
2.59
0.007
1.04
0.003
0.56
0.003
0.7
N/A
N/A
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InSight Technical Reference Manual
Table 4: Air Kerma (mG/h) Rate Perpendicular to Cathode - Anode Axis using ANSI Knee Phantom; 75 kVp/ .100 mA 45°
22.5°
0°
-22.5°
-45°
Distance (cm)
mG/h
mR/h
mG/h
mR/h
mG/h
mR/h
mG/h
mR/h
mG/h
mR/h
20
0.345
39.77
0.53
66.85
0.381
47.48
0.298
34.1
0.1
11.83
40
0.136
15.95
0.115
13.44
0.14
16.31
0.122
14.06
0.028
3.57
60
0.086
9.96
0.093
10.7
0.068
7.95
0.064
7.77
0.018
2.26
80
0.061
7.26
0.046
5.63
0.043
4.96
0.036
4.51
N/A
N/A
100
0.043
5.06
0.028
3.41
0.025
3.22
0.018
2.36
N/A
N/A
Table 5: Air Kerma (mG/h) Rate Parallel to Cathode - Anode Axis using Anthropomorphic Hand Phantom; 50 kVp/ .058 mA 45°
22.5°
0°
-22.5°
-45°
Distance (cm)
mG/h
mR/h
mG/h
mR/h
mG/h
mR/h
mG/h
mR/h
mG/h
mR/h
20
0.324
36.97
0.21
24.55
0.172
20.2
0.176
20.45
0.046
5.38
40
0.129
15.12
0.09
10.42
0.064
7.73
0.079
9.28
0.014
1.66
60
0.064
7.8
0.046
5.51
0.036
4.22
0.05
5.77
0.021
2.75
80
0.057
6.8
0.032
3.78
0.021
2.71
0.021
2.87
N/A
N/A
100
0.032
4
0.021
2.59
0.014
1.88
0.014
1.84
N/A
N/A
Table 6: Air Kerma (mG/h) Rate Parallel to Cathode - Anode Axis using Anthropomorphic Hand Phantom; 75 kVp/ .100 mA 45°
22.5°
0°
-22.5°
-45°
Distance (cm)
mG/h
mR/h
mG/h
mR/h
mG/h
mR/h
mG/h
mR/h
mG/h
mR/h
20
0.507
58.03
0.352
40.42
0.356
41.07
0.266
30.4
0.072
8.47
40
0.212
24.39
0.144
16.74
0.111
12.73
0.111
12.93
0.028
3.34
60
0.1
11.51
0.079
9.06
0.061
7.11
0.064
7.72
0.025
2.97
80
0.072
8.53
0.05
5.91
0.036
4.47
0.032
4.05
N/A
N/A
100
0.043
5.31
0.032
3.97
0.025
3.11
0.021
2.7
N/A
N/A
Page 9 of 17
InSight Technical Reference Manual
Table 7: Air Kerma (mG/h) Rate Perpendicular to Cathode - Anode Axis using Anthropomorphic Hand Phantom; 50 kVp/ .058 mA 45°
22.5°
0°
-22.5°
-45°
Distance (cm)
mG/h
mR/h
mG/h
mR/h
mG/h
mR/h
mG/h
mR/h
mG/h
mR/h
20
0.324
37.32
0.18
20.67
0.198
28.87
0.187
21.58
0.068
7.81
40
0.126
14.47
0.118
13.92
0.075
8.87
0.09
10.37
0.018
2.41
60
0.05
5.98
0.07
9.02
0.039
4.56
0.05
6.13
0.007
1.03
80
0.028
3.31
0.036
4.45
0.025
3.11
0.025
3.19
N/A
N/A
100
0.021
2.84
0.025
2.95
0.014
1.87
0.014
1.74
N/A
N/A
Table 8: Air Kerma (mG/h) Rate Perpendicular to Cathode - Anode Axis using Anthropomorphic Hand Phantom; 75 kVp/ .100 mA 45°
22.5°
0°
-22.5°
-45°
Distance (cm)
mG/h
mR/h
mG/h
mR/h
mG/h
mR/h
mG/h
mR/h
mG/h
mR/h
20
0.507
58.24
0.295
33.82
0.345
39.82
0.28
33.06
0.104
11.98
40
0.198
22.81
0.194
22.32
0.129
14.91
0.126
14.66
0.032
4.09
60
0.082
9.62
0.118
13.68
0.068
7.92
0.068
8.21
0.014
1.73
80
0.079
9.15
0.057
6.96
0.039
4.83
0.039
4.58
N/A
N/A
100
0.054
6.2
0.036
4.39
0.025
3.18
0.021
2.49
N/A
N/A
Page 10 of 17
InSight Technical Reference Manual
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 01730 USA
R
0044
Electrical rating: 100/120/220/240V
50/60 Hz, 750VA
50% Max Duty Cycle at 75kVp, 100uA
LBL-00377 Rev. 001
Patent Label The Patent Label is on the back of the base cabinet.
LBL-00237 Rev 001
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InSight Technical Reference Manual
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. 110365 REV 001
Electric Shock Warning Label The Electric Shock Warning Label is located near the fasteners for panels covering high voltage components.
LBL-00224 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, 2001. LBL-00228 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-00283 Rev 001
Transport Label The Transport Label is on the back of the unit, above the handle. TRANSPORT UNIT WITH C-ARM LOCKED LBL-00271 Rev 002
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InSight Technical Reference Manual
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 01730 USA
Serial Number: Date of Manufacture: LBL-00225 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.
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InSight Technical Reference Manual
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 equiv. @ 70 kVp Manufactured by: Hologic, Inc. 35 Crosby Drive Bedford, MA 01730 USA
Date of Manufacture: LBL-00227 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 01730 USA
Serial Number: Date of Manufacture: LBL-00232 Rev. 003
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InSight Technical Reference Manual
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 01730 USA
Serial Number: Date of Manufacture: LBL-00372 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 100-120V T10.0A/250V 5x20mm 220-240V T6.3A/250V 5x20mm (fuses are slow blow) LBL-00220 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-00229 Rev. 001
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InSight Technical Reference Manual
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-00230 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-00233 Rev. 001
Extremities Only Label The Extremities Only Label is located on the back of the base cabinet. For examination of extremities only. LBL-00234 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.
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