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5415035-1EN Rev02 9800-9900 Regulatory Reference Chart PDF
5415035-1EN Rev02 9800-9900 Regulatory Reference Chart PDF
5415035-1EN Rev02 9800-9900 Regulatory Reference Chart PDF
5415035-1EN
Rev 2
© 2011
GE OEC Medical Systems, Inc.
All Rights Reserved
Revision History
Rev Date Change Description
01 March 2011 Initial Release
02 Sept. 2011 Add countries to Table 1, Table 2
This manual may not be reproduced, in whole or in part, without the written permission of GE OEC Medical Systems, Inc.
OEC is a registered trademark of GE OEC Medical Systems, Inc. Other product and company names mentioned herein are the property of
their respective owners.
The contents of this document are accurate at the time of publication. However, changes in design and additional features can, at any time,
be incorporated in the hardware and software and may not be reflected in this version of the document. Contact GE OEC Technical Support
for clarification, if discrepancies arise.
GE OEC Medical Systems, Inc. a General Electric Company, going to market as GE Healthcare.
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For information on how the battery may be safely removed from the device, please consult the service
manual or equipment instructions. Information on the potential effects on the environment and
human health of the substances used in batteries is available at this url:
http://www.gehealthcare.com/euen/weee-recycling/index.html.
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警告 本维修手册仅提供英文版本。
(ZH-CN) 如果维修服务提供商需要非英文版本,客户需自行提供翻译服务。
未详细阅读和完全理解本维修手册之前,不得进行维修。
忽略本警告可能对维修人员,操作员或患者造成触电、机械伤害或其他
形式的伤害。
警告 本維修手冊僅有英文版本。
(ZH-TW)
如顧客的維修服務提供者要求英文以外的語言,顧客有責任提供翻譯的
服務。
除非已查閱並瞭解本維修手冊,否則請勿嘗試維修設備。
未注意本警告可能導致維修服務提供者、操作人員或病患遭受到觸
電、機械或其他危害。
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このサービスマニュアルは英語でのみ提供されています。
(JA) お客様のサービス担当者が英語以外の言語を必要とする場合、
翻訳作業の提供はお客様の責任となります。
このサービスマニュアルを熟読し理解してから、装置のサービスを
行なってください。
この警告に従わない場合、感電または、機械的もしくはその他の危険
要因により、サービス担当者、操作員、または患者が負傷する可能性
があります。
경고 본 서비스 지침서는 영어로만 이용하실 수 있습니다.
(KO)
고객의 서비스 제공자가 영어 이외의 언어를 요구할 경우, 번역 서비스를
제공하는 것은 고객의 책임입니다.
본 서비스 지침서를 참고했고 이해하지 않는 한은 해당 장비를
수리하려고 시도하지 마십시오.
이 경고에 유의하지 않으면 전기 쇼크, 기계상의 혹은 다른 위험으로부터
서비스 제공자, 운영자 혹은 환자에게 위해를 가할 수 있습니다.
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Introduction
The following chart(s) lists the factory settings of a system destined for a certain country. The chart is
organized in rows by country, and split into two tables: Dose Rate Limit Settings and UtilitySuite
Settings.
You are responsible to be aware of local regulations that are different, and for countries that are not
listed below. In those cases, the system should be set to local regulations during install or service of
the system. Some countries have additional optional settings defined per country in the Appendices.
The values in the tables are not used for I.I. Dose limit calibration. See the 9900 service manual
supplement manual or the 9800 service manual for the procedure for setting the II dose limits.
Note: The limits are verified in manufacturing in Continuous Normal Auto Fluoro, Continuous HLF, and
Digital CINE 25 or 30PPS modes, with two 1-mm copper filters over the collimator cover and the
dosimeter ion chamber centered directly on the image intensifier.
9800: If the ABS Table is set to Cardiac or Cardiac PT, temporarily change the ABS Table to what is
specified in Table 2, for the particular country, when measuring I.I. dose rates. Set the ABS Table back
to the original setting when finished.
9900: Use the General Profile (not Cardiac) when measuring I.I. dose rates. Return to original settings
when finished.
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UtilitySuite Settings
See Table 2.
The following settings are found in the “General Setup/Configuration” section in UtilitySuite:
1. Regulatory Group Type/ABS Tables: This is used to select the Domestic, International A, or
International B ABS table. It controls the dose to the image intensifier. On 9800 systems,
Cardiac and Cardiac PT ABS tables are also available for Cardiac systems (see note 9 for
further details). This is displayed in UtilitySuite as “Regulatory Group” for 9900, and “ABS
Tables” for 9800.
2. Fluoro Alarm Control Type: This controls the option to terminate x-rays after a set time
period.
3. Alarm Start Time: This controls the “Alarm Start Time” in seconds. The default is 295 seconds
(4 minutes 55 seconds).
4. Time Until Terminate: This sets the amount of time, in seconds, in addition to the alarm start
time, when a standard fluoro shot will terminate. This is set to 300 seconds (5 minutes) for
countries that have a 10-minute termination requirement.
5. Fluoro Beeper: This controls if the system emits an audible signal during exposures.
6. Terminate X-Rays: This controls whether the system terminates x-rays when the “Time Until
Terminate” time is reached.
7. HLF Alarm Timer: This sets the time, in seconds, for the maximum amount of time of an HLF
exposure.
8. Film Mode Enabled: This determines if the Film Mode feature is enabled.
9. HLF Enabled: This determines if the HLF feature is enabled.
Figure 1
Page 2
The following settings are found in the “GE OEC Personnel Privileged” section in Utility Suite:
1. Sync Rate: Sets video sync rate to either 30Hz or 25Hz
2. Dose Area Product Live Update: Determines if DAP is displayed.
3. Skin Dose Enable: Determines if Skin Dose is displayed.
4. Tube Type: Selects proper tube type.
For all 9900 systems: Select Tube Type 00-884653-01 Only
For 9800’s with tube model RAD-99: Select Tube Type 00-901318-02
For 9800’s with tube model RAD-99B: Select Tube Type 00-884653-01
Note: Tube model information can be found on the X-ray tube label located behind the swing down
panel on the C-Arm.
Figure 2
Figure 3
Note: For settings which use a checkbox to enable or disable the feature, a in the table indicates
that this setting is enabled, while a indicates that it is not enabled. The settings in the figures
above may not be specific for the particular system that is being configured. See the information
above and tables below to properly setup the system.
Page 3
1 The EER limits set during manufacturing are the regulatory limit minus 7.4% in Standard Fluoro and minus 10% in HLF to account for
dosimeter error and ion chamber positioning error.
2 As measured on top of the anti-scatter grid, with two 1mm copper filters in beam. For Fluoro and HLF, it is a continuous (non-pulsed) shot
in auto mode. For Digital CINE, it is either a 25PPS or 30PPS shot depending on the sync rate selected. All are normal magnification and
non-cardiac profile.
3 The limits, as stated by regulation, refer to the actual intensifier dose rate (see Table 4). The values stated in this column of Table 1 are
adjusted for a 72% grid transmission factor, and a 1% difference in distance between SID and Source to Grid distance. The result is the limit
as measured on top of the grid.
4 The dose to image intensifier HLF limit verified during manufacturing is the regulatory limit as measured on top of the grid minus 10% to
Table 1 represent dose rates and are calculated by multiplying the regulated dose per frame by the number of frames per minute. 25 FPS
(frame rate) is used for countries with a 25Hz sync rate, and 30FPS is used for countries with a 30Hz sync rate to convert to mGy/min.
6 These countries do not specify a dose at patient skin limits in the indicated mode. For these countries, the limit for manufacturing is the
USA.
8 For reference purpose only, the USA limits expressed in units of R are in Table 3. The manufacturing dose rates were converted from mGy
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UtilitySuite Settings
Table 2 - UtilitySuite Settings
Fluoro Alarm
Group / ABS
Alarm Start
Table Type9
Timer (sec)
Time Until
Terminate
Terminate
HLF Alarm
Film Mode
Live Update
Dose Area
Skin Dose
Enabled
Enabled
Control
Beeper
X-Rays
Fluoro
Product
Enable
Time
Type
Sync
Rate
(sec)
(sec)
Reg.
HLF
Country
Bolivia
Brazil
Chile
Colombia
Guatemala
Honduras
Jamaica Dom Intl 295 300 30 30
Panama
Philippines
Taiwan
Trinidad &
Tobago
Venezuela
Bermuda
Haiti
Peru Dom Intl 295 300 30 30
Saudi Arabia
South Korea
Bahamas
Canada
Costa Rica
Dom U.S. 295 N/A 30 30
Japan
Mexico
(continued)
9 For 9800, if the system configuration is Cardiac, choose Cardiac ABS Table instead of Domestic, and Cardiac PT ABS Table instead of
International A or B.
Page 6
Fluoro Alarm
Group / ABS
Alarm Start
Table Type9
Timer (sec)
Time Until
Terminate
Terminate
HLF Alarm
Film Mode
Live Update
Dose Area
Skin Dose
Enabled
Enabled
Control
Beeper
X-Rays
Fluoro
Product
Enable
Time
Type
Sync
Rate
(sec)
(sec)
Reg.
HLF
Country
(continued)
Puerto Rico Dom U.S. 295 N/A 30 30
USA
Algeria
Angola
Argentina
Austria
Bosnia
Brunei Bulgaria
Cambodia
Cameroon
Chad
Croatia
Cyprus
Czech Republic
Denmark
Egypt
Estonia
Ethiopia
Finland
France
Gabon
Georgia
Germany
Ghana
Greece
Greenland
Hungary
Iceland
Indonesia
Iraq
Ireland Intl A Intl 295 300 30 25
Jordan
Kenya
Kuwait
Laos
Latvia
Lebanon
Libya
Lithuania
Luxembourg
Macedonia
Malaysia
Malta
Montenegro
Morocco
Netherlands
Nigeria
Norway
Oman
Pakistan
Papua New-
Guinea
Paraguay
Poland
Romania
Russia
Rwanda
Senegal
(continued)
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Fluoro Alarm
Group / ABS
Alarm Start
Table Type9
Timer (sec)
Time Until
Terminate
Terminate
HLF Alarm
Film Mode
Live Update
Dose Area
Skin Dose
Enabled
Enabled
Control
Beeper
X-Rays
Fluoro
Product
Enable
Time
Type
Sync
Rate
(sec)
(sec)
Reg.
HLF
Country
(continued)
Serbia
Slovakia
Slovenia
South Africa
Sudan
Sweden
Intl A Intl 295 300 30 25
Tunisia
Turkey
UAE
UK
Ukraine
Uruguay
Vietnam
Bangladesh
China
Hong Kong
Intl A Intl 295 300 30 25
Israel
Singapore
Thailand
India Intl A U.S. 295 N/A 30 25
Belgium
Italy
Intl A Intl 295 300 30 25
Portugal
Spain
New Zealand Intl A Intl 295 300 20 25
Switzerland Intl A Intl 295 300 20 25
Australia Intl B Intl 295 300 20 25
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Appendix A: UK
The configuration described in this Appendix is appropriate for use in the UK. All of the settings listed
in the table must be used when using the optional settings. These settings can be utilized to reduce
the x-ray dose. A side effect of using this configuration is reduced image quality.
Table 5 – Optional Dose Rate Limit Settings for the UK
Patient Entrance Exposure Image Intensifier Entrance Dose Rates
Rates (EER) (mGy/min) for Iris Verification (μGy/min)
Regulatory
Country MFG Limits1 Manufacturing Range2 Regulatory Limits3
Limits
Fluoro Range HLF Digital CINE Range
Std HLF Std HLF Std HLF CINE5
9” System 12” System Limit4 9” System 12” System
UK 81.5 90.0 1007 100 18.0±2.2 13.0±2.3 N/A 254±39 184±31 N/A N/A N/A
Alarm Start
Timer (sec)
Table Type
Time Until
Terminate
Terminate
HLF Alarm
Film Mode
Live Update
Dose Area
Skin Dose
Enabled
Enabled
Control
Beeper
X-Rays
Fluoro
Product
Enable
Time
Type
Sync
Rate
(sec)
(sec)
Reg.
HLF
Country
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Appendix B: Israel
The configuration described in this Appendix is appropriate for use in Israel. All of the settings listed in
the table must be used when using the optional settings. These settings can be utilized to reduce the
x-ray dose. A side effect of using this configuration is reduced image quality.
Table 7 – Optional Dose Rate Limit Settings for Israel
Patient Entrance Exposure Image Intensifier Entrance Dose Rates
Rates (EER) (mGy/min) for Iris Verification (μGy/min)
Regulatory
Country MFG Limits1 Manufacturing Range2 Regulatory Limits3
Limits
Fluoro Range HLF Digital CINE Range
Std HLF Std HLF Std HLF CINE5
9” System 12” System Limit4 9” System 12” System
Israel 81.5 158.4 N/A N/A 39±5 29±4 N/A 280±40 203±33 N/A N/A N/A
Alarm Start
Timer (sec)
Table Type
Time Until
Terminate
Terminate
HLF Alarm
Film Mode
Live Update
Dose Area
Skin Dose
Enabled
Enabled
Control
Beeper
X-Rays
Fluoro
Product
Enable
Time
Type
Sync
Rate
(sec)
(sec)
Reg.
HLF
Country
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