Miniview 6800 CDRH Update

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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00-888764-02
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.
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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.
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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
ANATOMY kV µA DIMENSIONS
(mR/min)
in / cm
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.
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LOW DOSE ABS TABLE:

ANATOMY
DOSE RATE
ANATOMY kV µA DIMENSIONS
(mR/min)
in / cm
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

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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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Update

MiniView 6800 CDRH

CDRH compliance refers to Title 21, CFR, sections 1020.30, 1020.31,

Rev Dash Date Reason

Refer to the Standard Fluoro Table on the next page.

*AERC: Automatic Exposure Rate Control, which automatically adjusts

Low Dose Fluoro

Refer to the Low Dose Fluoro Table on the next page.

*AERC: Automatic Exposure Rate Control, which automatically adjusts

Fluoroscopic Technique -- Anatomy

LOW DOSE ABS TABLE:

Maximum Entrance Exposure

Air Kerma Rate and Cumulative

Customize Workstation Screen

Figure 1. Customize Workstation Screen

Dose Summary Screen

Figure 2. Dose Summary Screen

On the Dose Summary screen example above, under Cumulative Dose:

Dose Summary Screen's Display

If "mrad" is selected on the Customize Workstation screen (see Figure

Figure 3. Imaging Screen

Imaging Screen's Display Definitions

If "mrad" is selected on the Customize Workstation screen (see Figure

Figure 4. Label Locations

X-Ray Source Labels

Figure 5. X-ray Source Label, Active Up To June 10, 2006

Figure 6. X-ray Source Label, Active After June 10, 2006

X-Ray Warning Label

Figure 7. X-ray Warning Label

Air Kerma Scatter Rates

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