GE Healthcare
MiniView 6800 CDRH Update Rev B March 2006
Update
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Update 00-888764-02
MiniView 6800 CDRH Update Overview This Update contains information in compliance with regulations and specifications from the Center for Devices and Radiological Health (CDRH). New material in this Update implemented for CDRH compliance supercedes that found in the Operator's Manual. For example, there are some new screen displays and new labels. CDRH compliance refers to Title 21, CFR, sections 1020.30, 1020.31, 1020.32, 1020.33, reflecting amendments published in the Federal Register, June 10, 2005. This Update assumes the user is already familiar with basic operation of the MiniView 6800 system through use of the MiniView 6800 Mobile Imaging System Operator's Manual.
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Rev
Dash
Date
Reason
1
-01
Feb. 2006
Engineering Release
A
-01
Feb. 2006
Manufacturing Release
B
-02
March 2006
Revised, added new X-ray Source Label
© 2006 GE OEC Medical Systems, Inc. 384 Wright Brothers Dr. Salt Lake City, Utah 84116 All rights reserved
This Update may not be reproduced, in whole or in part, without the written permission of GE OEC Medical Systems, Inc. The material in this Update is provided for informational purposes only and is subject to change without notice. The text of this Update was originally written, approved and published by the manufacturer in English (P/N 00-888764-02). This Update contains descriptions, instructions, and procedures which apply only to GE OEC 6800 system.
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Table of Contents Overview ... 1 Modes of Operation ... 4 Standard Fluoro ... 4 Low Dose Fluoro ... 6 Fluoroscopic Technique -- Anatomy Factors ... 8 Maximum Entrance Exposure (Air Kerma) Rates ... 10 Air Kerma Rate and Cumulative Air Kerma Calculations ... 10 Customize Workstation Screen ... 11 Dose Summary Screen... 12 Dose Summary Screen's Display Definitions ... 13 Imaging Screen ... 14 Imaging Screen's Display Definitions ... 15 Label Locations ... 16 X-Ray Source Labels ... 17 X-Ray Warning Label ... 19 Air Kerma Scatter Rates ... 19
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Modes of Operation The 6800 system uses Standard and Low Dose Fluoro modes. Refer to the following Standard Fluoro, Low Dose Fluoro, and Fluoroscopic Technique -- Anatomy Factors sections for details.
Standard Fluoro Standard Fluoro mode displays live fluoroscopic images on the left monitor when the X-ray switch is activated. The system has a last image hold of the X-ray image when the X-ray switch is released. Refer to the Standard Fluoro Table on the next page.
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*AERC: Automatic Exposure Rate Control, which automatically adjusts techniques to display the optimum image quality for most X-ray images. Page 5
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Low Dose Fluoro Low Dose Fluoro mode utilizes technique factors that have a lower dose rate than Standard Fluoro mode for applications where patient dose is a concern. Like Standard Fluoro mode, it displays live fluoroscopic images on the left monitor when the X-ray switch is activated. The system has a last image hold of the X-ray image when the X-ray switch is released. Refer to the Low Dose Fluoro Table on the next page.
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*AERC: Automatic Exposure Rate Control, which automatically adjusts techniques to display the optimum image quality for most X-ray images. Page 7
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Fluoroscopic Technique -- Anatomy Factors The values in the following tables represent typical technique factors* for various extremity examinations. The optimum technique factors may vary depending on anatomical density and image field size. STANDARD ABS TABLE: ANATOMY DOSE RATE DIMENSIONS (mR/min) in / cm
ANATOMY
kV
µA
Hand
50
35.2
44
1.34 / 3.40
Wrist
50
36.5
46
1.75 / 4.45
Forearm
51
37.6
51
2.12 / 5.38
Foot (lateral)
53
45.4
74
2.72 / 6.91
Foot (AP)
54
47.4
77
3.13 / 7.95
Ankle
55
88
88
2.87 / 7.29
Knee (lateral)
59
65
165
4.03 / 10.24
Knee (AP)
58
65
175
4.07 / 10.33
Shoulder
64
78.4
301
5.20 / 13.20
*These are only typical technique factors in terms of the values shown in both the Standard and Low Dose ABS tables. Your values may be different due to variations in conditions and anatomy size.
CAUTION Although typical use of the MiniView C-Arm system produces lower scatter radiation levels (<5mrad/hour @ 1 meter), it is strongly recommended that protective X-ray apparel be worn and appropriate radiation safety precautions be followed. Page 8
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LOW DOSE ABS TABLE: ANATOMY DOSE RATE DIMENSIONS (mR/min) in / cm
ANATOMY
kV
µA
Hand
48
29.9
35
1.34 / 3.40
Wrist
49
30.5
42
1.75 / 4.45
Forearm
50
32.1
42
2.12 / 5.38
Foot (lateral)
55
37.6
66
2.72 / 6.91
Foot (AP)
54
36.8
63
3.13 / 7.95
Ankle
55
38.4
66
2.87 / 7.29
Knee (lateral)
61
47.8
120
4.03 / 10.24
Knee (AP)
60
47.8
131
4.07 / 10.33
Shoulder
64
58.8
240
5.20 / 13.20
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Maximum Entrance Exposure (Air Kerma) Rates < 2.5 R/min (22 mGy/min) with the skin spacer installed (20cm SSD [Source to Skin Distance]). < 10 R/min (88 mGy/min) at the exit port of the X-ray source assembly, with the skin spacer removed (10cm SSD).
Air Kerma Rate and Cumulative Air Kerma Calculations On the 6800 system, a distance of 15cm from the entrance point of the Fluoroscopic Imaging Assembly is used to acquire the value. This is accepted as the best estimate of the skin location for intended use.
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Customize Workstation Screen Figure 1 shows the new Customize Workstation screen. New to this screen: The AUTO PLAYBACK WHEN CINE ACQUIRED selection, and for DOSE UNITS, mGy (not mrad) is now the default selection.
Figure 1. Customize Workstation Screen
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Dose Summary Screen Figure 2 shows the new Dose Summary Screen. "mGy," showing the Air Kerma rate (or skin dose), is now the default unit on this screen.
Figure 2. Dose Summary Screen On the Dose Summary screen example above, under Cumulative Dose: radcm2 = Dose Area Product (DAP) mGy = skin dose
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Dose Summary Screen's Display Definitions If "mGy" is selected on the Customize Workstation screen (see Figure 1), then the Dose Summary screen displays the following units: mGym2 (for DAP) mGy (for skin dose) If "mrad" is selected on the Customize Workstation screen (see Figure 1), then the Dose Summary screen displays the following units: radcm2 (for DAP) mrad or rad for (for skin dose)
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Imaging Screen Figure 3 shows the new standard Imaging Screen, displayed on the left monitor. New to this screen: The brightness/contrast icons are now in the upper-right corner, and the lower-right corner displays "mGy" values. For clarity, the Figure 3 screen does not show an X-ray image.
Figure 3. Imaging Screen
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Imaging Screen's Display Definitions If "mGy" is selected on the Customize Workstation screen (see Figure 1), the Imaging screen displays the following units: mGy/min (for Air Kerma rate) mGy (for Cumulative Air Kerma) If "mrad" is selected on the Customize Workstation screen (see Figure 1), then the Imaging screen displays the following units: mR/min or R/min (for exposure rate) mrad or rad (for cumulative dose)
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Label Locations Figure 4 shows the locations of the X-ray Source label and X-ray Warning label. 1. X-ray Source label. 2. X-ray Warning label.
Figure 4. Label Locations Page 16
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X-Ray Source Labels Figure 5 shows the X-ray Source label which is used on systems until June 10, 2006. Figure 6 (next page) shows the X-ray Source label which will be used on systems after June 10, 2006.
Figure 5. X-ray Source Label, Active Up To June 10, 2006
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Figure 6. X-ray Source Label, Active After June 10, 2006
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X-Ray Warning Label Figure 7 shows the new X-ray warning label.
Figure 7. X-ray Warning Label
Air Kerma Scatter Rates For the 6800 system's scatter rate information, refer to the OEC MiniView 6800 Air Kerma Scatter Rates document, part number 00-885591-01.
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