Though this equipment is built to the highest standards of electrical and mechanical safety, the useful xRay beam becomes a source of danger in the hands of the unauthorized or unqualified operator. Excessive exposure to x-radiation causes damage to human tissue.
Therefore, adequate precautions must be taken to prevent unauthorized or unqualified persons from
operating this equipment or exposing themselves or others to its radiation.
Before operation, persons qualified and authorized to operate this equipment should be familiar with the
recommendation of the International Commission on Radiological Protection, contained in the latest
Annals of the ICRP, and with applicable national standards and should have been trained in use of the
equipment.
This product complies with the following requirements:
Council Directive 93/42/EEC concerning medical devices when it bears the following CE marking of conformity:
The location of the CE mark label on the equipment is in the service system manual.
EU Authorized Representative:
GE Medical Systems SCS
283 rue de la Minière
78530 BUC, FRANCE
Green QSD 1990 Standard issued by MDD (Medical Devices Directorate, Department of Health, UK).
Medical Device Good Manufacturing Practice Manual issued by the FDA (Food and Drug Administration,
Department of Health, USA).
Underwriters' Laboratories, Inc. (UL), an independent testing laboratory.
Canadian Standards Association (CSA).
International Electrotechnical Commission (IEC), international standards organization, when applicable.
GE Healthcare reserves the right to make changes in specifications and features shown herein, or discontinue the product described at any time without notice or obligation.
Update Table Warning Labels and picture of lock
Add a new section of “Digital Cassette Imaging in Extended Table Detector Tray” in
Chapter 8.
Update wallstand light ring in Chapter 8.
Add 120cm wallstand grid and 120cm table grid in Chapter 8.
Add image recovery in Chapter 10.
Add field size of Collimator in Chapter Appendix B.
Update some screenshots.
324 Mar 2015Add Brazil UWB Certification Information in Chapter 2
Update Identification Plate No. of Workstation PC (Z420) into 5840000-3 in Chapter
2
Update digital detector specifications in Chapter 7
Modify Image pasting drawing of illustration of acquisition in Chapter 13
Update Power Supply Conditions in Appendix B: Specifications
421 July 2015Add a warning explanation to patient load label in Chapter 2
Delete “United states” from “United states Federal law restricts this device to sale by
or on the order of a physician” in Chapter 1 and Chapter 2
Flash Pad Detector (URP) part No. 5340000-3 be updated into 5340000-7 in Chapter
2
Workstation PC (Z420) part No. 5840000-3 be updated into 5843000-3 in Chapter
2
Add a sentence of “Please wait at least 60 seconds
Perform QAP section of Chapter 14
506 Nov 2015Update patient load label and its instruction in Chapter 2
618 Feb 2016Added 2nd Manufacturer in Contact Information.
added 5843001-3 into Identification and Compliance Plates in Chapter 2.
701 Apr 2016Update Contact Information
Add UDI Label into Identification and Compliance Plates in Chapter 2
823 Jan 2017To add Standard Table & Manual Wallstand and upgraded Collimator, detailed
revise happened together with having corrected legend errors as below.
1. In chapter 2: Revised Table 2-5 Maximum Attenuation Equivalent mm AL with
adding new items and correcting legend errors under section General Use Warnings; Revised Table 2-14 Identification Plate with adding new items and correcting
legend errors under section Identification Plate and Compliance Plates Location;
Added
a new section Standard Table Warning Labels under section NRTL Listed
Label; Added a warning for standard table load capability under section Patient
Positioning Warnings;
2. In chapter 4: Revised Figure 4-8 Emergency Stop buttons and corrected a Caution under section Emergency Stop.
3. In chapter 5: Corrected a Caution under section Emergency Stop button.
4. In chapter 7: Added “Do not stand on the grid” under section Grid Handling.
5. In chapter 8: Revised the configurations and the note in section Configurations;
Revised Table 8-1 Major system components with adding new components under
section Component Identification; Revised Table 8-2 Available Options with adding
new options under section Available Accessories; Revised multi-leaf collimator
description and Figure 8-13 Collimator controls under section Multi-Leaf Collimator;
Revised Figure 8-14 Multi-leaf collimator display under section Collimator Display; In
section Digital Wallstand, added word “digital” in several places in order to differentiate Digital Wallstand with new Manual Wallstand; added Wallstand chin rest as
applied part. Added a new section Manual Wallstand after section Digital Wallstand; In section Digital Table, added word “digital” in several places in order to differentiate Digital Table with new Standard Table; revised a Caution of item 7 in table
8-13, too. Added a new section Standard Table after Digital Table section; Revised
section Digital Cassette Imaging in Extended Table Detector Tray with clinical input;
Added a new section Standard Table Hand Grips and Compression Band after section Digital Table Hand Grips and Compression Band; Corrected an error on Lateral
Bridge Lengths by deleting 4.5 meter bridge (option).
6. In chapter 10: Added a Caution for labeling mitigation following up; Added a note
in section Conduct a Wallstand Exam. Added a note in section Conduct a Table Top
Exam and section Conduct a Cassette Exam.
7. In chapter 13: deleted “(not available in USA)” at the title “Dual Energy”.
8. In chapter 14: corrected the wrong service documentation part numbers under
section General and Periodic Maintenance Schedule.
9. In chapter 15: corrected an error in the first paragraph under section Add or Edit
DICOM Printers; Added a caution into section Retrieve Protocol Database from CD or
DVD.
10. In Appendix B: added specifications for new Standard Table and Manual Wallstand. Meanwhile corrected some legend errors on OTS, tables, Wallstand and storage conditions.
What is more, Labeling category was cleaned up throughout this manual. Copyright
time was revised through this manual, too.
918 May 2017This revise is revised for Wireless Regulatory Information and manual wallstand fol-
low up action in operator manual. Detailed as below.
1. In Medical Device Directive: Deleted original wireless Regulatory statement under
Medical Device Directive.
2. In chapter 2: Added a new sub_section Wireless Regulatory Information under
section UWB Compliance Statement; Added a Caution under section General Use
Warnings; Added a symbol under section Special Notices; Added a Caution under
section Patient Positioning Warnings.
3. In chapter 5: Added a Caution under section General Acquisition.
4. In chapter 8: Revised Figure 8-36 and added a warning under section Remove or
Attach the Lateral Positioning Bar.
5. In chapter 14: Added some information on an expected service life of 10 years
under section Qualified Service section.
The equipment is intended for use by qualified personnel only.
CAUTIONFederal law restricts this device to sale by or on the order of a physician.
This Operator Manual should be kept with the equipment and be readily available at all times. It is important for you to periodically review the procedures and safety precautions. It is important for you to read
and understand the contents of this manual before attempting to use this product.
This chapter explains the purpose and design of this Operator Manual. It provides information on the
organization, chapter format, and graphic conventions that identify the visual symbols used throughout
the manual.
How to access the electronic version of a
manual on a website
The Operator Manual is available through the GE Customer Website at:
http://www3.gehealthcare.com/en/Global_Gateway
Note: A file compression/archival (zip/unzip) utility must be installed on the user’s computer.
1. Select country.
2. Click on Documentation Library under Support.
3. Select X-ray Modality and reference desired manual.
5. In the next window, click [ACCEPT] to view the file.
6. From the zip file, choose your language (EN).
Technical Manual Updates
When operating or servicing GE Healthcare products, please contact your GE representative for the latest
version of product documentation. Product documentation may also be available on-line at the GE
Healthcare support documentation library.
Scope Of This Manual
This manual is intended for health care professionals trained in radiological science, and is intended to
introduce you to the system components and features. It is not intended to teach radiological science or
make any type of clinical diagnosis.
Prerequisite Skills
This guide is not intended to teach radiology. It is necessary for you to have sufficient knowledge to competently perform the various diagnostic imaging procedures within your modality. This knowledge is
gained through a variety of educational methods including clinical working experience, hospital based
programs, and as part of many college and university Radiologic Technology programs.
Please refer to Chapter 2: Safety and Regulatory in this manual. The Safety chapter describes the safety
information you and the physicians must understand thoroughly before you begin to use the system.
Note that you will find additional safety information throughout your Learning and Reference Guide. If
you need additional training, seek assistance from qualified GE Healthcare personnel. The equipment is
intended for use by qualified personnel only. This guide should be kept with the equipment and be readily
available at all times. It is important for you to periodically review the procedures and safety precautions.
It is important for you to read and understand the contents of this guide before attempting to use this
product.
Safety Notices
Safety notices are used to emphasize certain safety instructions. This guide uses the international symbol
along with the danger, warning, or caution message. This section also describes the purpose of a Note.
DANGERDanger is used to identify conditions or actions for which a specific hazard is
known to exist which will cause severe personal injury, death, or substantial property damage if the instructions are ignored.
WARNINGWarning is used to identify conditions or actions for which a specific hazard is
known to exist which may cause severe personal injury, death, or substantial
property damage if the instructions are ignored.
CAUTIONCaution is used to identify conditions or actions for which a potential hazard may
exist which will or can cause minor personal injury or property damage if the
instructions are ignored.
IMPORTANT! An Important comment calls your attention to items that affect your workflow or image
quality but do not involve the safety of people or equipment.
Note: A Note provides additional information that is helpful to you. It may emphasize certain informa-
tion regarding special tools or techniques, items to check before proceeding, or factors to consider about a concept or task.
This manual refers to “controls” that appear on the software screens. Table 1-2 describes the most common controls that appear on the software user interface.
Table 1-2 Common software user interface controls
Control and DescriptionExamples
Button
Screen buttons look and act like
physical buttons on equipment.
A single button performs a specific
action, such as opening a new screen
or saving settings.
A group of two or more buttons
provides a choice of settings, such as
which acquisition mode is active. The
dark blue color indicates which button
or buttons are selected.
Drop down list
Drop down lists open to reveal several
options, but only one option may be
selected at a time.
Drop down lists may be included on a
button or a text box.
The presence of a drop down list is
indicated by a down-pointing arrow on
the right side of the control.
Tabs are similar to the tabs on file
folders. They categorize related
information on a single screen.
Clicking on a tab reveals the
information related to that tab. Clicking
on another tab hides the previous
information and reveals a different set
of information.
Checkbox
Checkboxes indicate selection.
A single checkbox shows that an
option is active.
Multiple checkboxes show that several
options are selected.
A tab to move between two screens
A single checkboxMultiple checkboxes
Text box
Text boxes
Text boxes allow information to be
entered using the keyboard.
The targeted clinical users include qualified trained doctors, radiographers, or radiologic
technologists (RTs) working in various locations. Locations may include orthopedic clinics,
radiology imaging centers, hospital radiology departments, or hospital orthopedic depart-
ments.
Safety
The electrical wiring of the relevant rooms complies with all national and local codes, as well
as the Regulations for the electrical equipment of buildings published by the Institution of
Electrical Engineers. All assembly operations, extensions, re-adjustments, modifications, or
repairs are carried out by GE Healthcare Technologies authorized service representatives. The
equipment must be used in accordance with the instructions for use.
WARNINGThis X-Ray unit may be dangerous to patient and operator, unless safe
exposure factors, operating instructions and maintenance schedules
are observed.
CAUTIONTo be used by authorized personnel only.
WARNINGElectric Shock Hazard! Do not remove covers or panels. The Acquisition
Console and cabinets contain high voltage circuits for generating and
controlling X-rays. Prevent possible electric shock by leaving covers or
panels on the equipment. There are no operator serviceable parts or
adjustments inside the cabinets. Only trained and qualified personnel
should be permitted access to the internal parts of this equipment.
CAUTIONOnly GEMS/GEHC validated equipment can be plugged into the outlets
in the control room wallbox. Current leakage requirements of non-validated equipment cannot be maintained with high confidence.
WARNINGAll system components, including the OTS (Overhead Tube Suspension),
Table, Wallstand, and Operator Console must obtain their power from
the Power Distribution Unit (PDU) in the System Cabinet.
WARNINGRadiographic equipment must be operated by qualified personnel and
only after sufficient training.
WARNINGTo avoid the risk of electric shock, this equipment must only be con-
nected to a supply mains with protective earth.
CAUTIONRestrict access to the EQUIPMENT in accordance with local regulations
for RADIATION PROTECTION.
CAUTIONDo not lay any object on the cabinets that would restrict air flow from
the top of the cabinet.
CAUTIONAlways be alert to safety when you operate this equipment. You must be
familiar enough with the equipment to recognize any malfunctions that
can be a hazard. If a malfunction occurs or a safety problem is known to
exist, do not use this equipment until qualified personnel correct the
problem.
CAUTIONIt is the User’s responsibility to provide the means for audio and visual
communication between the Operator and the patient.
CAUTIONUse only manufacturer recommended equipment and accessories.
Read and understand all of the instructions in this Operator Manual before attempting to use
the product.
IEC Equipment Classifications
This product is a stationary general purpose radiographic x-ray system. The following equip-
ment classifications are applicable to this product:
Equipment classification with respect to protection from electric shock: Class I
Degree of protection from electric shock: Type B
Degree of protection against ingress of liquids: IPX0
Equipment not suitable for use in the presence of a flammable anesthetic mixture with air
or with nitrous oxide;
Mode of operation: Continuous with intermittent loading
This equipment meets the following Safety Standards:
IEC 60601-1
IEC 60601-1-1
IEC 60601-2-32
IEC 60601-2-7
IEC 60601-2-28
IEC 60601-2-54
IEC 60601-1-3
UWB (Ultra WideBand) Compliance Statement
For Japan
The frequency band used for the UWB radio function is also used for radio equipment of other
radio systems.
The use of equipment with UWB radio function shall be limited to indoors, i.e. within envi-
ronments such as houses, apartments, buildings, etc. Not approved for outdoor use. Even
when used indoors, such as at broadcast events , please confirm with the event organizer
about the use of UWB radio function as it might cause interference to broadcasting operations.
The use of equipment with UWB radio function may cause influence to radio astronomy
operations, etc. When the equipment is used near a radio astronomy observatory, contact
the following address.
In case that harmful interference to other non-UWB radio equipment (satellite earth sta-
tion antennas, 5GHz band wireless LAN, mobile phones, etc.) is caused due to the emission from the UWB radio function of the equipment, take discretionary actions, such as to
remove the UWB radio equipment from the interfering area. If interference remains,
promptly stop the radio emission and contact the following address: Contact us at:
______________________________________
Note: The “UWB radio function” stated in the operation manual refers to the wireless com-
munication function of the UWB radio systems.
For Canada
Canada, Industry Canada (IC) Notices
This Class B digital apparatus complies with ICES-003, Issue 4, February 7 2004 and RSS 220,
Issue 1, March 2009 and RSS GEN, Issue 3, 2010.
Operation is subject to the following two conditions:
This device may not cause interference
This device must accept any interference including interference that may cause unde-
sired operation of the device.
For United States
FCC Radiation Exposure Statement
WARNINGThe radiated output power of this device is far below the FCC radio fre-
quency exposure limits. Nevertheless, this device should be used in such
a manner that the potential for human contact during normal operation
is minimized. To avoid the possibility of exceeding the FCC radio frequency exposure limits, you should keep a distance of at least 20 cm
between you (or any other person in the vicinity) and the antenna.
Interference Statement
These devices comply with Part 15 of the FCC Rules. Operation of the devices is subject to the
following two conditions:
The devices may not cause harmful interference
The devices must accept any interference that may cause undesired operation.
This equipment has been tested and found to comply with the limits for a Class B digital
device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable
protection against harmful interference in a residential installation. This equipment gener-
ates, uses, and can radiate radio frequency energy. If the equipment is not installed and used
in accordance with the instructions, the equipment may cause harmful interference to radio
communications. There is no guarantee, however, that such interference will not occur in a
particular installation. If this equipment does cause harmful interference to radio or television
reception (which can be determined by turning the equipment off and on), the user is encour-
aged to try to correct the interference by taking one or more of the following measures:
Increase the separation between the device and the receiver.
Connect the device into an outlet on a circuit different from that of other electronics.
Consult the dealer or an experienced radio technician for help.
Note: This device must be installed and used in strict accordance with the manufacturer's
instructions as described in the user documentation that comes with the product. Any
other installation or use will violate FCC Part 15 regulations.
For Australia
The frequency band used for the UWB radio function is also used for radio equipment of other
radio systems.
The use of equipment with UWB radio function shall be limited to indoors, i.e. within environ-
ments such as houses, apartments, buildings, etc. Not approved for outdoor use.
For New Zealand
The frequency band used for the UWB radio function is also used for radio equipment of other
radio systems.
1. The use of equipment with UWB radio function shall be limited to indoors, i.e. within environments such as houses, apartments, buildings, etc. Not approved for outdoor use.
2. The use of equipment with UWB radio function is not permitted onboard any aircraft.
3. Should interference occur to services licensed pursuant to a radio license or a spectrum
license, the chief executive reserves the right to require and ensure that any transmission
pursuant to this General User Radio License change frequency, reduce power, or cease
operation. Should any of these conditions present themselves, promptly stop the radio
emission and contact the address and telephone number listed in the front of this manual.
The wireless parts come with the following software versions:
Table 2-2
ItemNameSoftware / Firmware Version
1UWB Host Dongle5398846-4 Rev. 2
2URP Wireless Detector5420645 Rev. 1
EU Authorized Representative:
GE Medical Systems SCS
283 rue de la Minière
78530 BUC, FRANCE
Safety Design in Wireless Link
System will inhibit the x-ray exposure during exam if the wireless image link is poor or broken
due to low signal quality or unintended radio frequency (RF) interference. System will recover
the wireless link and lift the inhibit when the signal quality exceeds the threshold or the interference stops. Wired connection (tether mode) is provided as a backup option when the RF
environment cannot support a reliable wireless link.
Declaration of Conformity (for RED)
The wireless parts listed above are CE marked according to the provisions of the RED Directive
(2014/53/EU). GE Medical Systems LLC., here by declares that these parts are in compliance with
the essential requirements and other relevant provisions of Directive 2014/53/EU.
The Declarations of Conformity made under Directive 2014/53/EU are available on the website.
Please refer to the section How to access the electronic version of a manual on website under
chapter 1.
Note: Power line anomalies or electrostatic discharges in all equipment areas may cause
the monitor image to become momentarily disrupted or to go to blank; the mouse
and/or keyboard may become inoperable or an error may be displayed on the worklist
or image viewer screens. the system may recover by itself or you may need to reboot
the system. the system may shut itself down, and will require a reboot.
CAUTIONA power surge during image transmission to the workstation after
acquisition may cause the image to be lost.
WARNINGWhen trying to fix the monitor video loss or inoperable mouse issues,
cycling the system power on/off may cause the monitor to display “can’t
open boot device error” message. if so, contact GE healthcare service.
CAUTIONFor continued safe use of this equipment, use only manufacturer recom-
This equipment complies with IEC 60601-1-2 Edition 2.1 (2004-11) EMC standards for medical
devices.
This equipment generates, uses, and can radiate radio frequency energy. The equipment may
cause radio frequency interference to other medical and non-medical devices and radio
communications.
To provide reasonable protection against such interference, this product complies with the
radiated emission standard limits as per CISPR11 Group1 Class A standard limits. However,
there is no guarantee that interference will not occur in a particular installation.
If this equipment is found to cause interference (which may be determined by turning the
equipment on and off), the user (or qualified service personnel) should attempt to correct the
problem by one or more of the following measure(s):
•Reorient or relocate the affected device(s)
•Increase the separation between the equipment and the affected device (see
recommended separation distances)
•Power the equipment from a source different from that of the affected device
•Consult the point of purchase or service representative for further suggestions
Use of accessories, transducers, cables and other parts other than those specified by the
manufacturer of this equipment may result in increased emissions or decreased immunity of
the equipment.
The manufacturer is not responsible for any interference caused by using other than
recommended interconnect cables or by unauthorized changes or modifications to this
equipment. Unauthorized changes or modifications could void the users' authority to operate
the equipment.
All interconnect cables to peripheral devices must be shielded and properly grounded, except
when technologically prohibited. Use of cables not properly shielded and grounded may
result in the equipment causing radio frequency interference.
The Optima XR646 systems are predominantly intended for use in non-domestic
environments, and not directly connected to the Public Mains Network that supplies buildings
used for domestic purposes.
The compatible accessories must be used within the recommended operating conditions
outlined in the operation manuals. In addition to calibration and warm-up, other devices must
be reset before and after use to ensure accurate dose measurements. Sustained exposure to
electromagnetic fields (exceeding the test conditions) may cause false measurements. Failure
to follow the recommended use may cause false measurements.
The magnetic field environment from a MRI device located nearby is a risk of interference.
All of the above are required to achieve the Electromagnetic Compatibility for a typical
installation of the system. Further detailed data & requirements are described in the Use
Recommendations and Installation Recommendations sections.
Compatibility Tables
This equipment complies with IEC 60601-1-2 Edition 2.1 (2004-11) EMC standards for medical
devices.
The Optima XR646 systems are suitable to be used in an electromagnetic environment, as per
the limits & recommendations described in the tables hereafter:
•Emission Compliance level & limits (Table 2-5).
•Immunity Compliance level & recommendations to maintain equipment clinical utility (see
Table 2-6 and Table 2-8).
NOTE: This system complies with above mentioned EMC standard when used with supplied
cables.If different cable lengths are required, contact a qualified service representative
for advice.
1. Electromagnetic Emission
Table 2-3 Guidance and manufacturer’s declaration – electromagnetic emissions
Guidance and manufacturer’s declaration – electromagnetic emissions
The Optima XR646 is intended for use in the electromagnetic environment specified below. The customer or the user
of The Optima XR646 should assure that it is used in such an environment.
Voltage fluctuations/
flicker emissions,
IEC 61000-3-3
Class A
Complies
The Optima XR646 uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not likely to cause
any interference in nearby electronic equipment.
The Optima XR646 is suitable for use in all establishments other than
domestic and those directly connected to the public low-voltage
power supply network that supplies buildings used for domestic
purposes.
Table 2-4 Guidance and manufacturer’s declaration – electromagnetic immunity
Guidance and manufacturer’s declaration – electromagnetic immunity
The Optima XR646 is intended for use in the electromagnetic environment specified below. The customer or the user of the Optima
XR646 should assure that it is used in such an environment.
Immunity TestIEC 60601 Test LevelCompliance Level Electromagnetic Environment Guidance
Electrostatic discharge
(ESD), IEC 61000-4-2
Electrical fast transient/
burst, IEC 61000-4-4
Surge, IEC 61000-4-5
Voltage dips, short
interruptions and
voltage variations on
power supply input
lines, IEC 61000-4-11
Power frequency (50/60
Hz) magnetic field,
IEC 61000-4-8
+/− 6 kV contact.
+/− 8 kV air.
+/− 2 kV for power supply
lines.
+/− 1 kV for input/output
lines.
±1 kV differential mode
±2 kV common mode
< 5% UT (> 95% dip in UT)
for 0.5 cycle.
40% UT , (60% dip in UT)
for 5 cycles.
70% UT , (30% dip in UT)
for 25 cycles.
< 5% UT, (> 95% dip in
UT) for 5 cycles
3 A/m3 A/m
+/− 6 kV contact.
+/− 8 kV air.
+/− 2 kV for power
supply lines.
+/− 1 kV for input/
output lines.
±1 kV differential
mode
±2 kV common
mode
< 5% UT (> 95%
dip in UT) for 0.5
cycle.
40% UT , (60% dip
in UT)for 5 cycles.
70% UT , (30% dip
in UT)for 25
cycles.
< 5% UT, (> 95%
dip in UT) for
5 cycles
Floors should be wood, concrete, or
ceramic tile. If floors are covered
with synthetic material, the relative
humidity should be at least 30%.
Mains power quality should be that
of a typical commercial or hospital
environment
Mains power quality should be that of a typical
commercial or hospital environment.
Mains power quality should be that of a typical
commercial or hospital environment. If the
user of the system requires continued
operation during power mains interruptions, it
is recommended that the system be powered
from an un-interruptible power supply or a
battery.
Power frequency magnetic fields should be at
levels characteristic of a typical location in a
typical commercial or hospital environment.
NOTE: UT is the a.c. mains voltage prior to application of the test level.
Table 2-5 Guidance and manufacturer’s declaration – electromagnetic immunity
Guidance and manufacturer’s declaration – electromagnetic immunity
The Optima XR646 is intended for use in the electromagnetic environment specified below. The customer or the user of The Optima
XR646 should assure that it is used in such an environment.
Immunity TestIEC 60601 Test LevelCompliance Level Electromagnetic Environment Guidance
Conducted RF,
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms,
150 kHz ~ 80 MHz
3V/m
80 MHz~2.5GHz
3Vrms
3V/m
Portable and mobile RF communications equipment
should be used no closer to any part of the Optima
XR646,
including cables, than the recommended separation
distance calculated from the equation appropriate for
the frequency of the transmitter.
Recommended Separation Distance
80 MHz to 800 MHz
800 MHz to 2.5 GHz
where, P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation
distance in metres (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey
should
be less than the compliance level in each frequency
b
range
.
Interference may occur in the vicinity of equipment
marked with the following symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from
structures, objects and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios,
amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the
electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field
strength in the location in which the Optima XR646 is used exceeds the applicable RF compliance level above, The Optima XR646
should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as
re-orienting or relocating the Optima XR646.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Table 2-6 Recommended separation distances between portable and mobile RF
communications equipment and the Optima XR646 – for EQUIPMENT and SYSTEMS that are
not LIFE-SUPPORTING
Recommended separation distances between portable and mobile RF communications equipment and the Optima XR646
The Optima XR646 is intended for use in an electromagnetic environment in which radiated RF disturbances are
controlled. The customer or the user of The Optima XR646 can help prevent electromagnetic interference by maintaining
a minimum distance between portable and mobile RF communications equipment (transmitters) and The Optima XR646
as recommended below, according to the maximum output power of the communications equipment.
Separation distance according to frequency of transmitterm
150 kHz to 80 MHz80 MHz to 800 MHz800 MHz to 2.5 GHz
Rated Maximum Output Power (P)
of Transmitter Watts (W)
0.010.12 0.12 0.23
0.10.37 0.37 0.74
1 1.17 1.17 2.33
10 3.69 3.69 7.38
100 11.67 11.67 23.33
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres
(m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output
power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by reflection from
structures, objects and people.
Radiation Safety
Always use the Optimal technical factors for each procedure to minimize X-ray exposure and
to produce the best diagnostic results. In particular, you must be thoroughly familiar with the
safety precautions before operating this system.
CAUTIONThere should be no people other than the patient in the exam room
during x-ray exposure. If circumstances require another person to enter
the room while x-ray exposures are planned or possible, that person
should wear a lead apron in accordance with accepted safety practices.
Because exposure to X-ray radiation may be damaging to health, use great care to provide
protection against exposure to the primary beam. Some of the effects of X-ray radiation are
cumulative and may extend over a period of months or years. The best safety rule for X-ray
operator is “Avoid exposure to the primary beam at all times”.
Any object in the path of the primary beam produces secondary (scattered) radiation. The
intensity of the secondary radiation is dependent upon the energy and intensity of the
primary beam and the atomic number for the object material struck by the primary beam.
Secondary radiation may be of greater intensity than that of the radiation reaching the film.
Take protective measures to safeguard against it.
An effective protective measure is the use of lead shielding. To minimize dangerous exposure,
use such items as lead screens, lead impregnated gloves, aprons, thyroid collars, etc. The lead
screen should contain a minimum of 2.0 mm of lead or equivalent and personal protective
devices (aprons, gloves, etc.) must contain a minimum of 0.25 mm of lead or equivalent. For
confirmation of the local requirements at your site, please refer to your “Local Radiation
Protection Rules” as provided by your Radiation Protection Advisor.
CAUTIONWhile operating or servicing x-ray equipment, always keep a distance
not less than 2 meters from the focal spot and X-ray beam, protect body
and do not expose hands, wrists, arms or other parts of the body to the
primary beam.
Monitoring of Personnel
Monitoring of personnel to determine the amount of radiation to which they have been
exposed provides a valuable cross check to determine whether or not safety measures are
adequate. It may reveal inadequate or improper radiation protection practices and potentially serious radiation exposure situations.
The most effective method of determining whether or not the existing protective measures
are adequate is the use of instruments to measure the exposure. These measurements
should be taken at all locations where the operator, or any portion of the body may be
exposed. Exposure must never exceed the accepted tolerable dose.
A common method of determining whether personnel have been exposed to excessive radiation is the use of personal radiation dosimeters. These consist of X-ray sensitive film or thermoluminescent material enclosed within a holder that may be worn on the body. Even though
this device only measures the radiation which reaches the area of the body on which they are
worn, they do provide a reasonable indication of the amount of radiation received.
It is not always possible to determine when some components, such as the X-ray tubes, are
nearing the end of their operating lives. These components could stop operating during a
patient examination.
CAUTIONThe facility must establish procedures for handling the patient in case of
the loss of radiographic imaging or other system functions during an
exam.
Emergency Devices
The system has two types of Emergency buttons:
Emergency Stop- when pressed, Lateral Table, OTS and Wallstand motions are halted, generation of X-rays is stopped. The system aborts any data acquisition in progress, and attempts
to save all data acquired prior to the abort. Use the Emergency Stop button for patient related
emergencies.
System Emergency Off Button- when pressed, the power to all system components is
removed, stopping all motion and generation of X-rays. The system aborts any acquisitions in
progress, and data obtained prior to the abort can become corrupt or lost. Use the System
Emergency OFF button for catastrophic emergencies, such as fire or earthquake.
Note: After Emergency Stop / System Emergency Off Button is enabled, there is still longitu-
dinal movement of table available. Use caution when removing patient, if necessary.
CAUTIONIf you press the Emergency Stop or Emergency OFF buttons during x-ray
exposure, the system will abort the data acquisition.
Emergency Stop
Note: Every operator should take a few minutes to locate the Emergency Stops on his or her
WARNINGFor continued safe use of this equipment, follow the instructions con-
tained in this Operator Manual. Study this guide carefully before using
the equipment and keep it at hand for quick reference. It may be desirable for the facility to print this manual from a standard PC to have a
hard copy available within the Radiology department.
WARNINGOnly qualified personnel trained in the operation of this equipment
should operate this system. Read and become familiar with all instructions in this manual before using this equipment. If further assistance is
needed, please contact GE.
WARNINGIt is the responsibility of the owner to make certain that only properly
trained, fully qualified personnel are authorized to operate the equipment. A list of authorized operators should be maintained.
WARNINGCheck for obstructions before moving the system (table, gantry or
other); do not drive the system into or onto fixed objects.
WARNINGIf applicable, patient connected lines, tubes, etc. shall be long enough to
allow full travel of the system and will not become pinched or pulled.
WARNINGPotential Pinch Point: Use table foot pedals with care when lowering the
table. Clearance is limited next to the table side cover, and a pinch point
may exist for the operator.
WARNINGIt is the responsibility of the operator to ensure the safety of the patient
at all times. When the table is in use the patient should be monitored by
visual observation, use of proper patient positioning, and use of the protective devices provided.
CAUTIONKeep the patient in full view at all times and never leave the patient
unattended while on the table.
WARNINGThoroughly check that there is no interference or possibility of collision
between the patient and other equipment.
CAUTIONPlease carefully monitor all equipment motions to prevent collisions.
Attention shall be drawn during operation to prevent possible injuries
that could result from collision of the power-driven equipment parts
with other moving or stationary items likely to be in the environment.
WARNINGPerform periodic maintenance to ensure continued safe use of the
equipment. Follow recommended preventative maintenance schedule
as outlined in the GE Field Service Manual.
CAUTIONCollision with the OTS may cause minor injury. Ensure there is no one in
the path of the OTS during positioning.
CAUTIONMake sure any other accessories or materials are not located in the pri-
mary X-ray beam during exposure that could result in bad image quality.
CAUTIONSome experts believe that use of any keyboard may cause serious injury
to hands, wrists, arms, neck, or back.
CAUTIONAlways use GEHC recommended accessories to ensure best perfor-
mance and to avoid possible hazards.
CAUTIONDo not load non-system software onto the system computer.
WARNINGThe collimator uses lasers to create the linear centering cross beams.
Laser radiation. Do NOT stare into beam! When you switch on the linear
laser light localizer, make sure no person looks directly into the laser to
avoid eye injuries or impaired vision. (Peak power 1 mw / wave length
540-700 nm / class II laser product.)
Figure 2-3 Collimator laser label
CAUTIONUse of controls or adjustments or performance of procedures other than
those specified herein may result in hazardous radiation exposure.
CAUTIONTo avoid patient injury, always assist the patient on or off the table at
the beginning or end of an exam.
CAUTIONMake sure that patient connected lines, tubes, etc. are long enough to
allow full travel of the system and will not become pinched or pulled.
WARNINGDuring patient procedures, ensure the patient’s head, hands and feet
are completely within the tabletop area. If any portion of the patient’s
body extends over the edge of the tabletop, serious injury may result.
CAUTIONThe technologist must remain close to the patient when the remote con-
trol is in use.
WARNINGThe digital table maximum supported weight, with full tabletop func-
tionality is 320 kg (705lbs.).
Exceeding the limit may cause equipment damage or injury to the
patient.
WARNINGThe standard table shall have a maximum evenly distributed load capa-
bility of 250kg (552lbs).
Exceeding the limit may cause equipment damage or injury to the
patient.
CAUTIONThe table is designed to remain stable under normal conditions, but
when necessary for special patient loads and positioning, it will move
when sufficient force is applied. If no longitudinal movement or if abnormal patient loading is required, modifications must be made to ensure
the tabletop is locked longitudinally into position.
CAUTIONThe OTS tracks to the wallstand receptor. Use caution when moving
receptor in small room configurations. Always be sure that the patient is
clear of the OTS before selecting a wallstand configuration.
WARNINGThe OTS is designed to remain stable under power on conditions. When
power to the system is removed, the OTS may drift up or down.
CAUTIONThe wallstand lateral positioning bar is a hand rest only and is not
intended to support a person’s full weight. To avoid falls and potential
injuries, do not hang or pull on the bar.
CAUTIONThe operator can’t change detector connection mode before the image
is displayed on monitor after exposure.
Tabletop Motion Warnings
CAUTIONWhen the power to the table is off, the tabletop can move freely. To
avoid injuries, monitor the tabletop movement .
WARNINGPrior to raising or lowering the tabletop, ensure there are no obstruc-
tions present, above or below.
CAUTIONBefore the patient gets on or off the tabletop, always press the Table
Control Lock button. This momentarily blocks the foot pedal functions
and avoids injuries to the patient or damage to the equipment if a control pedal is accidentally engaged.
WARNINGTo avoid injury to fingers and hand do not allow the patient's or opera-
tor's fingers to be extended over the edges of the tabletop. Hands must
be kept away from table top edges at all times.
CAUTIONPotential Pinch Point: The area where the tube connects to
the column may create a pinch point when the tube is
rotated. Operators should keep their hands on the OTS handle and keep patient’s clear while rotating the tube.
OTS - Collimator
CAUTIONAlways grasp the multi-leaf collimator in such a way that
neither hand can be pinched or crushed between the handles and the collimator.
Wallstand
Chapter 2: Safety and Regulatory
CAUTIONHand Crush Hazard: Keep your extremities and the patient’s
extremities away from the pinch areas and the top of the
wallstand arm when tilting the wallstand receptor.
Acquisition
Workstation
CAUTIONPotential Pinch Point: The DVD/CD tray can open and close
automatically.
Symbols
This section explains the symbols used on this system and in its accompanying documents.
Special Notices
Table 2-9 Special notices
SymbolDescription
Dangerous voltage. This indicates an avoidable, dangerous, high voltage hazard.
This symbol on the equipment indicates the operating instructions should be
consulted to ensure safe operation.
Hand crushing hazard. This symbol indicates that serious injury to the hand may
occur.
Follow Instructions for use
No stepping or standing on unit. The component on which the symbol appears
cannot support the weight of a person. Damage to equipment or injury may occur if
the unit is stepped or stood upon.
Maximum load. This symbol indicates that the component has a maximum weight
limit. Damage to equipment or injury may occur if the maximum weight is exceeded.
Chapter 2: Safety and Regulatory
Operating temperature. This symbol indicates that the component must be within a
minimum and maximum temperature range in order to operate. Damage to
equipment may occur if equipment is used at temperatures outside of the specified
range.
Emergency Stop Button. It’s used to immediately power down the system (including
table, OTS, wallstand, and x-ray tube) and stop image exposure.
Reference Number.
Serial Number.
Date of Manufacture.
e-IFU symbol.
The symbol indicates the instruction for use of the device is supplied in electronic
Gost Mark.
This mark indicates that the Device is confirmed according Russian standards.
The symbol indicates the instruction for use of Lateral positioning bar.
Chapter 2: Safety and Regulatory
X-ray Tube Operational Symbols
Table 2-10 describes the operational symbols for the system such as X-ray emissions and col-
limator locations.
Table 2-10 Operational symbols
SymbolDescription
X-ray emission is used to indicate the X-ray tube head is emitting X-rays. Take
adequate precautions to prevent the possibility of any persons carelessly, unwisely,
or unknowingly exposing themselves or others to radiation.
X-ray source assembly is used to indicate a reference to an X-ray source assembly.
X-ray tube is used to indicate a reference to the X-ray tube, e.g., to mark the surface
of a grid, which is to be oriented towards the X-ray tube.
Identifies controls or indicators associated with normal rotational speed of the X-ray
anode.
Identifies controls or indicators associated with high rotational speed of the X-ray
anode.
Identifies controls or indicators associated with the selection of a small focal spot or
the connection for the corresponding filament .
Identifies controls or indicators associated with the selection of focal spot or the
connection for the corresponding filament . When used with the small focal spot
symbol, this symbol applies to the larger focal spot. When used with the large focal
spot symbol, this symbol applies to the smaller focal spot.
Identifies controls or indicators associated with the selection of a large focal spot or
the connection for the corresponding filament .
System Power On and Reset
Chapter 2: Safety and Regulatory
Table 2-11 describes the power controls of the system, located on the RCIM. (Refer to
Chapter 8: System Hardware Overview
more information.)
Table 2-11 Power controls
SymbolDescription
The SYSTEM RESET button is used to reset the system. The button is located on
the RCIM.
The POWER ON button is used to turn on the power to the system. The button is
located on the RCIM.
-Radiology Control Interface Module (RCIM) (p. 8-6) for
Table 2-12 describes the electrical protection rating based on system type.
Table 2-12 Electrical type
SymbolDescription
Type B Equipment indicates the equipment provides a particular degree of
protection against electrical shock regarding leakage current and protective
earthing per IEC60601-1.
Electrical Current
Table 2-13 describes the symbols for the different types of electrical current that may be used
on your system.
Chapter 2: Safety and Regulatory
Table 2-13 Electrical current types
SymbolDescription
Alternating Current indicates the equipment is suitable for alternating current
only.
Direct Current indicates the equipment is suitable for direct current only.
Both direct and alternating currents indicate the equipment is suitable for both
direct and alternating current.
Table 2-14 describes the different types of grounding used in your system.
Table 2-14 Ground types
SymbolDescription
Functional Earth (ground) Terminal indicates a terminal directly connected to a
point of a measuring supply or control circuit or to a screening part , which is
intended to be earthed for functional purposes.
Noiseless (clean) earth (ground) identifies any terminal of a specially designed
earthing system where noise from earth of leads will not cause a malfunction of
the equipment.
Protective earth (ground) identifies any terminal which is intended for
connection of an external protective conductor to protect against electrical
shock in case of a fault.
Chapter 2: Safety and Regulatory
Frame or chassis identify the frame or chassis terminal.
Equipotentiality identifies terminals that bring the various parts of equipment or
systems to the same potential when connected together. These terminals are
not necessarily at earth (ground) potential. The value of the potential may be
indicated next to the symbol.
Product identification labels can be found on the tops and sides of the cabinets, the rear of
monitors, and other exterior surfaces on the equipment. The types of system identification
compliance plates are located in Table 2-16.
Identification Plate and Compliance Plate Locations
Table 2-16 Identification Plate
ComponentsIdentification PlateLocation
Bridge5127305Top of rear end cap
Chapter 2: Safety and Regulatory
Overhead Tube
Suspension
(OTS)
X-ray Tube Casing
MX100
09PS
X-ray Tube Insert .6-
1.25
12.5 degree MX100
Collimator5234954
Workstation PC (Z420)5843000-3
Optima XR646 System
Rating Plate
System rating plate for
Optima XR646 WSO
System Cabinet 5397035Top of unit, on right side towards front.
5135678-3
or 5135678-4
46-155400G285Rear of X-ray tube.
2336058Rear of X-ray tube.
5730663
5843001-3
5502131
5730354
Rear of largest column.
Rear of collimator.
Top front of PC
Top of system cabinet
Top front of PC
Jedi 80 Rad 1T2374870Top of unit, on right side towards front. Also inside
system cabinet, on left side of Jedi Control Assembly.
Jedi HV Tank2186730Inside system cabinet, on front of Jedi HV Tank
Digital Radiographic
Table
Table Ion Chamber5143310Inside table detector housing.
Tether Interface Box5394349Under cover, on right side.
Detector BIN5394348Under cover, on right side.
Flexi-DT Table
(purchasable option)
5143310 (3-cell)
5261064 (4-cell)
5340000-7Top of unit.
5194670On lower frame, behind right front wheel.
Left side of carriage.
Inside wall stand detector housing
NRTL Listed Label
The Nationally Recognized Testing Laboratory (NRTL) label indicates that the assembly is
listed or recognized by a nationally recognized testing laboratory (i.e. ETL, UL, CSA)
1. The table can be moved vertically when the load is less than or equal to 220 kg (485 lbs),
located in the center of the tabletop end and the tabletop is positioned in the center.
Chapter 2: Safety and Regulatory
2. The table can be moved vertically when the distributed load over the table is less than or
equal to 320 kg (706 lbs) and the tabletop is positioned in the center.
3. The table cannot be moved vertically and the tabletop shall be positioned in the center
when the distributed load over the table is more than 320 kg (706 lbs) and less than or
equal to 400 kg (882 lbs).
WARNINGWhen the patient weight exceeds 220 kg (485 lbs) then patient on/off load of
the table should only occur from the center of the front or rear side of the
table. (Maximum weight 400 kg (882 lbs))
1. The table can be moved vertically when the load is less than or equal to 180kg (397lbs),
located in the center of the tabletop end and the tabletop is positioned in the center.
2. The table can be moved vertically when the distributed load over the table is less than or
equal to 250kg (552lbs) and the tabletop is positioned in the center.
CAUTIONWhen the patient weight exceeds 180kg (397lbs) then patient on/off load of
the table should only occur from the center of the front or rear side of the
table (Maximum weight 250kg (552lbs)).
WARNINGThis X-Ray unit may be dangerous to the patient and operator, unless
safe exposure factors, operating instructions and maintenance schedules are observed. To be used by authorized personnel only.
UDI Label
Every Optima XR646 system has an unique marking for identification. The Unique Device
Identification (UDI) marking appears on the product label which is located on system cabinet .
UDI: Unique Device Identifier - A UDI is an unique numeric or alphanumeric identification code
assigned to medical devices by the manufacturer of the device. An unique device identification marking is applied to a Product Model that is designated as a medical device as per FDA
UDI regulation.
Note: This equipment generates, uses, and can radiate radio frequency energy. The equip-
ment may cause radio frequency interference to other medical and non-medical
devices and radio communications. To provide reasonable protection against such
interference, this product complies with emission limits for Group 1 Class A Medical
Devices as stated in EN 60601-1-2. However, there is no guarantee that interference
will not occur in a particular installation.
Note: If this equipment is found to cause interference (which may be determined by switch-
ing the equipment on and off), you (or qualified service personnel) should attempt to
correct the problem using one or more of the following measures:
- Reorient or relocate the affected devices.
- Increase the space separating the equipment and the affected device.
- Power the equipment from a source different from that of the affected device.
- Consult the point of purchase or the service representative for further suggestions.
Note: The manufacturer is not responsible for any interference caused either by the use of
interconnect cables other than those recommended or by unauthorized changes or
modifications to this equipment. Unauthorized changes or modifications could void
the user’s authority to operate the equipment.
Note: To comply with the regulations applicable to an electromagnetic interface for a Group
1 Class A Medical Device, all interconnect cables to peripheral devices must be
shielded and properly grounded. The use of improperly shielded and grounded cables
may result in the equipment causing radio frequency interference in violation of the
European Union Medical Device directive and Federal Communications Commission
regulations.
Note: Do not use devices which intentionally transmit radio frequency (RF) signals (cellular
phones, transceivers, or radio controlled products) in the vicinity of this equipment, as
it may cause performance outside the published specifications.
Keep the power to these type devices turned off when near the equipment.
The medical staff in charge of this equipment is required to instruct technologists, patients,
and other people who may be around this equipment, to fully comply with the above requirement.
This product complies with the following requirements:
Council Directive 93/42/EEC concerning medical devices when it bears the following CE marking of conformity:
This symbol indicates that the waste of electrical and electronic equipment must not be disposed as unsorted municipal waste and must be collected separately. Please contact an
authorized representative of the manufacturer for information concerning the decommissioning of your equipment.
Figure 2-15 Disposal of waste symbol
Battery Disposal
The separate collection symbol is affixed to a battery, or its packaging, to advise you that the
battery must be recycled or disposed of in accordance with local or country laws. The letters
below the separate collection symbol indicate whether certain elements (Pb=Lead, Cd=Cadmium, Hg=Mercury) are contained in the battery. To minimize potential effects on the environment and human health, it is important that all marked batteries that you remove from the
product are properly recycled or disposed.
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:
The following product pollution control information is provided according to SJ/T11364-2006
Marking for Control of Pollution caused by Electronic Information Products.
Figure 2-17 Pollution control symbol
This symbol indicates the product contains hazardous materials in excess of the limits established by the Chinese standard SJ/T11363-2006 Requirements for Concentration Limits for
Certain Hazardous Substances in Electronic Information Products. The number in the symbol
is the Environment-friendly Use Period (EFUP), which indicates the period during which the
toxic or hazardous substances or elements contained in electronic information products will
not leak or mutate under normal operating conditions so that the use of such electronic information products will not result in any severe environmental pollution, any bodily injury or
damage to any assets. The unit of the period is Year.
In order to maintain the declared EFUP, the product shall be operated normally according to
the instructions and environmental conditions as defined in the product manual, and periodic
maintenance schedules specified in Product Maintenance Procedures shall be followed
strictly.
Consumables or certain parts may have their own label with an EFUP value less than the
product. Periodic replacement of those consumables or parts to maintain the declared EFUP
shall be done in accordance with the Product Maintenance Procedures.
This product must not be disposed of as unsorted municipal waste, and must be collected
separately and handled properly after decommissioning.
The x-ray source assembly is comprised of the x-ray tube and collimator. Together they provide permanent, non-removable filtration of 2.7 mm aluminum equivalent @ 71 kVp. Additional collimator filtration is user selectable. Refer to Chapter 8: System Hardware Overview
-
Multi-Leaf Collimator (p. 8-26) for detailed information.
CAUTIONThis system is designed to be used with only the GE MX100 tube and col-
limator model number 5234954. Replacement of either of these components with different types may render the system non-compliant to
applicable radiation safety standards and regulations.
Dose/DAP Indication
The Dose/DAP value is predicted by calculation. They are displayed on the image viewer for
each exposure. The Dose value is calculated at the position of patient entrance.
Figure 2-18 Block diagram for Dose/DAP calculation:
The nominal Dose is calculated at the calibrated distance, based on exposure techniques,
such as mAs, kVp and additional filtration. The final patient entrance dose is got by correcting
with SID and tube angle and the preset patient thickness.
DAP is got by multiplying Patient entrance dose and the image area at that distance.
Increase/decrease of the kVp, mAs, will lead to increase/decrease of Dose and DAP
Increase/decrease of the SID only, will lead to decrease/increase of Dose and DAP
Increase/decrease of the FOV only, will lead to increase/decrease of DAP, but Dose will not
change.
With the disposal of waste products, residues and equipment accessories that are out of their
expected service life, to avoid the impact of environment, please comply with local statute or
call GE Service.
GE Healthcare strongly suggests reducing radiation dose to As Low As Reasonably Achievable (ALARA) in
all patients, especially pediatric and small patients, whenever it is determined that an x-ray is necessary.
X-ray is an extremely valuable tool for diagnosing injury and disease, but its use is not without risk. This
section discusses the importance of minimizing the radiation dose in children and small adults consistent
with ALARA principles.
Topics covered include:
•Pediatric Use
•Optimize Pediatric Protocols for your facility
•What Do I Need to Know About?
Pediatric Use
Radiation exposure is a concern in both adults and children. However, children are more sensitive to
radiation. Using the same exposure parameters on a child as used on an adult may result in larger doses
to the child. X-ray settings can be adjusted to reduce dose significantly while maintaining diagnostic
image quality.
Optimize Pediatric Protocols for your facility
The protocols supplied with the system represent examples for procedures commonly conducted in
radiography. Based on the needs of a particular practice, these protocols may be modified to optimize
factors such as image quality or dose reduction.
Work with your team of Radiologists, Medical Physicists and Technologists to evaluate techniques that
may reduce radiation dose and provide adequate diagnostic information. In addition to the
recommended protocols installed on your system and suggestions in this guide, the following websites
offer excellent sources of additional information on how to optimize protocols:
•American College of Radiology (ACR): www.acr.org
•Society of Pediatric Radiology (SPR): www.pedrad.org
•National Cancer Institute (NCI): www.nci.nih.gov/aboutnci
•Image Gently: www.imagegently.org
•US Food and Drug Administration (FDA): www.fda.gov
This section presents the concepts necessary to understand Pediatric x-ray imaging. The concepts you
need to understand are:
•Radiation Exposure Sensitivity
•Suggestions for Minimizing Unnecessary Dose
•Guidelines for Adjusting Individual Exposure Parameters by patient
•Patient Dose Reporting
•Dose Index Reporting Considerations
•Protocol Database Edit
Everyone shares the responsibility of minimizing pediatrics dose. There are several steps that can be
taken to reduce the amount of radiation that pediatrics and small patients receive from x-ray
examinations.
Radiation Exposure Sensitivity
Radiation exposure is a concern in all people of all ages, however, pediatrics are more sensitive to
radiation exposure. Radiation risk is higher in the young as they have more rapidly dividing cells than
adults. The younger the patient, the more sensitive they are.
Suggestions for Minimizing Unnecessary Dose
•Image the Anatomical Region Indicated (Collimation): Collimation and anatomical coverage should
be carefully considered prior to each exposure. Follow your facility imaging guidelines to determine
appropriate collimation.
•Properly Center All Patients: In addition to collimation, centering of intended anatomy should be
considered. This is especially true when utilizing AEC/ion chambers. Improper centering over ion
chambers may cause more or less than the desired dose which may lead to overexposure or repeat
exposure.
•Check Technical Factors Before Exposure: Review technical display carefully before making an
exposure to verify selected and intended technique are the same. Pay particular attention to
placement of decimal point in display of numerical values.
•Use Pediatric Positioning Accessories: Approved Pediatric positioning accessories are often useful for
certain patients and exams. These may be helpful in decreasing motion that may contribute to
repeat exposure. Understand your facilities guidelines when implementing these devices.
•Protective Apparel/Barriers/Shielding: When applicable, utilize proper protective measures as they
comply with your facility guidelines.
•Consider Patient Radiation Safety Protocols: Ensure understanding and conformance of Patient
Radiation/Protection Safety and ALARA principles as required by your facility. This includes patient
shielding to reduce exposure to unintended areas.
Guidelines for Adjusting Individual Exposure Parameters
by patient
Adjust Parameters: The single most important thing you can do is to always use pediatric protocols to
avoid over exposure. Protocols based on patient size are installed on the system. There are six patient
sizes available: Adult and Pediatric; Small, Medium and Large Patient Size. These protocols should be
considered a baseline. GE strongly recommends that you work with your Radiologist and Physicist to
determine the lowest possible dose for the desired image quality.
Figure 3-1 Patient Size
Once patient size is selected, further adjustments to kVp, MAS, Filtration and Grid can be made to further
minimize patient dose.
Automatic - Exposure or Fixed Exposure: Consideration should be made when utilizing Automatic
Exposure (AEC) or Fixed Exposure. Each protocol on your system has been installed with a preset method
of exposure; however, GE recommends reviewing each protocol and utilizing the method that will allow
for the lowest possible dose.
Use of ion chambers for AEC require careful positioning of patient and should be considered prior to
making an exposure. GE recommends that each facility work with your Radiologist and Physicist. Refer to
Image Acquisition Chapter located in this operator manual for more information on AEC chambers and
sensing areas.
Estimates of patient dose are calculated after each acquisition and displayed (optionally) as part of the
image annotations. The information is also stored in the DICOM header of each image. Reference Patient
Dose Reporting in this operator manual for more information.
– Dose Index Reporting Consideration
Your system is provided with a Dose Index visual indicator. This indicator is displayed as an amount of
exposure received by the receptor. These are estimated ranges and can be changed as technical factors
are changed. Reference the DEI/DI section of this operator manual for more information.
Protocol Database Edit
In collaboration with your Radiologist and Physicist, protocol techniques can be changes as a default on
your system. This should not replace observing the technical acquisition screen carefully prior to each
exposure, but can assist in displaying an appropriate range of techniques for selected pediatric size.
Further changes to techniques are recommended based on each individual patient.
Refer to the Protocol Database Edit chapter in this operator manual to ensure proper editing. Always
complete a protocol database back up. Should any changes occur to your system, the database back up
may be retrieved with saved protocols.
For questions or further information, contact your local GE Healthcare representative.
This chapter explains some of the basic operations and features of the system such as how to start up
and shutdown the system software, how to login and log off, and how to view system status and messages.
Refer to Chapter 8: System Hardware Overview
for information about identifying system components.
This section describes the procedure for starting up and shutting down the system.
The system should remain on at all times for optimal performance. However, a controlled system shut
down and start up should be performed once a week as part of routine QAP. Refer to Chapter 14: Quality
Assurance and Maintenance for more information.
If the receptor loses power for 30 minutes or more, reset the system and warm the receptor with active
power in “on” state for at least 30 minutes. Refer to System Emergency OFF Buttons
information.
Start Up
1. Press the Power On button on the RCIM [Radiology Control Interface Module].
Figure 4-1 Power button on RCIM
(p. 4-10) for more
2. Wait a few minutes until the entire system is powered.
The system powers up automatically.
If enabled, the Login screen appears on the monitor when the system is ready. Refer to Login and
Log off (p. 4-4) for more information.
If Login is not enabled, the Worklist appears on the monitor when the system is ready. Refer to
Chapter 9: Worklist
3. Wait for the detector to boot . This takes approximately 30 seconds.
A message in the system status area will appear: “Detector Boot is in progress. Please wait 29 sec-
onds for the detector boot to complete.”
The system is ready when the detector boot message disappears.
Note: Wait approximately 30 seconds after a shutdown to power up the system.
Login and Log off
The following sections apply if the system is configured to use the Login feature in the Utilities User Interface, Refer to Appendix A: Login Administration
Standard Login
The Login screen (Figure 4-4) appears when the system is started, reset, and after a user logs off. The system may also be configured to display the Login screen if the system has been inactive for a specified
period of time (inactivity timeout).
Figure 4-4 Example login screen.
for information on administering the login function.
Follow this process to login to the system.
1. Start up the system or log off the previous user.
The Login screen appears.
2. Enter your Login Name.
3. Enter your Password.
4. Click [LOGIN].
The Worklist appears. Refer to Chapter 9: Worklist
Your Password must be entered correctly for you to log in. If the password you entered is not the correct
password for the selected User name, an error message will appear in the top portion of the Login
screen: “Logon Failed. Check that the CAPS LOCK Key is off. For assistance, contact your system administrator.“
1. Make sure that the correct Login Name is displayed in the field. Depending on the configuration, the
Login Name may be case sensitive. That is, “aBc” is not the same Login Name as “Abc.”
2. Retype your Password carefully. Your password is case sensitive; that is, “xYz” is not the same password as “Xyz.”
3. Click [LOGIN].
Contact your technical support group or system administrator if you still are not able to login.
Emergency Login
Emergency Login is a HIPAA required function to allow quick access to medical systems in the event of an
emergency. Depending on the system’s configuration, this option may not be available. Refer to
Appendix A: Login Administration
to configure the Emergency Login function.
Emergency Login will allow exposures, but does not allow connection to HIS/RIS or PACS hosts.
CAUTIONThe Emergency Login function should NOT be used when there is time to login nor-
mally, when there is time to receive assistance from technical support, or if there
is no emergency situation.
1. Click [EMERGENCY LOGIN].
You are prompted to enter your name. Enter your name and click [LOGIN]
2. The Worklist screen appears. Refer to Chapter 9: Worklist
Depending on the system’s configuration, the system may show the Login screen after a specified period
of inactivity. The Login screen acts as a screen saver, covering displayed information to protect patient
privacy.
The administrator configures if the system will time out and how long the system must be inactive before
the Login screen appears. Refer to Appendix A: Login Administration
function.
To access the system screens, follow the Standard Login or Emergency Login process described above.
to configure the inactivity time out
Log Off
1. Close, suspend, or discontinue any open exams, if necessary. (Refer to Chapter 10: Image Acquisition-
End Exam (p. 10-31) for more information.)
2. Close the Image Viewer, if necessary.
3. Click [LOGOFF] at the top of the Worklist or Image Management screen.
Or open the Utility screen, go to System and click [LOGOFF] (Figure 4-5).
Figure 4-5 Utilities screen logoff button
A message appears: “Do you really want to log off?”
4. Click [OK].
The Login screen appears.
[CANCEL] closes the screen and returns you to the last screen.
Your system has a series of interlocks that can place the system in an exposure hold state. When certain
conditions exist outside of normal operation, the red LED on the user interface becomes lit.
Grid Interlock
If the Grid interlock is activated, the Exposure Hold icon will appear on the OTS user interface and at the
Acquisition workstation screens. Select the Exposure Hold icon for detailed description on the inhibit condition.
Automatic Exposure Control (AEC) Interlock
If the tube is not centered laterally and longitudinally on the center ion chamber, the Exposure Hold icon
may appear on the OTS user interface and at the Acquisition workstation screens. If the tube is not centered laterally and longitudinally on the center ion chamber, the Exposure Hold icon for detailed description on the inhibit condition.
OTS Position Interlock
When the X-ray field is outside of the receptor area and/or not in lateral or SID detents, the Exposure
Hold icon will appear on the OTS user interface and at the Acquisition workstation screens. Select the
Exposure Hold icon for detailed description on the inhibit condition.
Note: This interlock is no longer active when the tube angle is > +/- 10 degrees.
Tube Pivot Interlock
The Tube Pivot interlock LED illuminates when the tube pivot must be rotated to 0 degrees (normal position).
Free Cassette Interlock
When in Free Cassette mode (using CR or film for Table top receptor) the detector drawer in the table
must be pulled out to release the optical sensor that recognizes that the cassette is in place, or the detector must be removed completely. If the Free Cassette mode is selected without releasing this optical sensor, the Exposure Hold icon will appear on the OTS user interface and at the Acquisition workstation
screens. Select the Exposure Hold icon for detailed description on the inhibit condition.
Table Finger Pinch Interlock
The table is equipped with optical sensors beneath the edges of the table between the emergency stop
button and table lock button on each side. The sensor stops lateral and longitudinal movement of the
table top if fingers or other objects are beneath the table edges, as shown in Figure 4-6.
The system will beep and a message will appear on the Acquisition Workstation informing you of the
table lock. Exposures will be inhibited until the lock is resolved.
To unlock the table top:
1. Release the Table top positioning foot pedal (if necessary).
Figure 4-7 Table top positioning foot pedal
2. Remove hands, fingers, or other object from under the table edge.
3. Press the table top positioning foot pedal (Figure 4-7) two consecutive times (“double-tap”).
4. Hold the foot pedal down and position the table top.
Emergency stop immediately powers down the system—including table, OTS, wallstand, and x-ray tube—
and stops image exposure. The digital table and RCIM are equipped with Emergency Stop buttons
(Figure 4-8).
To engage: Press the button.
To release: Turn (RCIM) or pull (table) the e-stop button to release.
Figure 4-8 Emergency Stop buttons
RCIM
Digital Table Standard Table
Use this procedure to perform an emergency stop and to reset the Emergency Stop button.
1. In an emergency situation, press the Emergency Stop button in with force.
2. Resolve the emergency situation.
CAUTIONFor Digital table, when the Emergency Stop button has been activated, the table
will move longitudinally only. The table is not locked into position. Exercise
extreme caution with your patient when this happens.
3. When normal conditions are confirmed, turn (RCIM) or pull (table) the e-stop button to reset.
The system will power up automatically.
Note: If turn the e-stop button on RCIM to reset, turn the button clockwise (indicated by the arrows on
In the event of a fire, flood, earthquake, or any other catastrophic emergency, all power to the system
should be turned off. Pressing the System Emergency OFF button immediately removes all power to the
system by removing power to the System Cabinet. Because the system has no time to save data, or shutdown in an orderly fashion, pressing the System Emergency OFF button can corrupt system files or result
in loss of patient data.
The facility designer determines the quantity and locations of the Emergency OFF buttons. GE recommends placing at least one Emergency OFF button near the doorway of every room in the system scan
suite. Ask your supervisor to show you the location of all the Emergency OFF buttons in the system suite.
Follow facility guidelines to report an emergency. Press the System Emergency OFF button (red, circular
button located on the wall) in the event of a catastrophic emergency, such as fire or earthquake.
System Reset
Should the system require a reset, this may take up to 3 minutes to complete.
Note: The system will not be available for acquiring images during the reset cycle.
1. If possible, close, suspend, or discontinue any open exams. (Refer to Chapter 10: Image Acquisition
End Exam (p. 10-31) for more information.)
2. If possible, log off the system.
3. Press and hold the RESET button on the RCIM until you hear the beep or the monitor screen goes
black with white text . Release the button and wait until the Login or Worklist screen appears.
4. Release the button and wait until the Login or Worklist screen appears.
As the system resets, various screens will appear on the monitor. This is normal.
The system will auto-start and either the Login screen or Worklist screen will appear (depending on
how your system is configured) when the system is ready. Refer to Start Up
mation.
(p. 4-2) for more infor-
Tube Warm Up
To extend the life of the tube, tube warm up should be done if no exposures have occurred within two
hours. A warning icon will display when tube warm up is needed.
CAUTIONInitiating an exposure when the X-ray tube is cold may damage the tube target.
Click [WARM TUBE] (Figure 4-11) at any time to see the tube heat status.
Tube Heat StatusShows the current status of the tube.
Warm up needed in __ MinShows how many minutes until the tube needs to be warmed.
A time of 0 minutes means that the tube must be warmed immediately.
Exposure RequiredShows the number of exposures required to warm the tube.
Soak Time RemainingShows how many seconds of soak time remain.
Exposure HoldLists any inhibits to making an exposure or warming the tube.
kVShows the kV of the current exposure.
mAShows the mA of the current exposure.
mAsShows the mAs of the current exposure.
mSecShows the mSec of the current exposure.
[CLOSE]Closes the Warm Tube screen.
Follow this process to warm up the tube.
CAUTIONX-rays are generated during tube warm up. Use proper radiation practices at all
times.
1. Check the room to make sure it is clear of other personnel before making X-ray exposures.
2. Click [WARM TUBE] on the Worklist screen.
Note: Because the tube warming procedure produces x-rays, it cannot be performed when an exam is
open. If the tube must be warmed before the exam can begin, suspend the exam and remove the
patient and any others from the room before warming the tube. Refer to Chapter 10: Image
Acquisition-End Exam (p. 10-31) for more information.
3. Correct any exposure holds.
CAUTIONExposures should not be made on any detector during tube warm-up. The system
will attempt to mis-align the tube and the detector, but you may need to manually
move the tube so that the detector is not exposed during the warm-up sequence.
Pay close attention to system message information for instructions to manually
move the detector. Exposing the detector may cause a “burned in” image artifact.
4. Press the Hand-switch Prep/Expose button to the Expose position and hold until the Exposures
Required reads “0”.
Note: The exposure hand switch should be held for 18 consecutive exposures to ensure proper tube
warm up. The Exposures Required number counts down as each exposure is made.
5. Wait until the Soak Time reads “0”.
6. Click [CLOSE] to finish tube warm up.
You may now continue taking x-rays.
Identification of Radiographs
As in any Radiography procedure, identification of images is important to ensure proper anatomical reference. Users should take extra care to ensure their image marker/identification placement prior to
exposure is optimal and included in the field of view.
All users are recommended to follow their Institution’s guidelines for image marker implementation.
Note: Use of electronic/annotated markers as part of post processing is not recommended as a pri-
mary method of image identification because of potential user error in identifying anatomical
regions.
Image Markers
Image markers (e.g. lead markers) are commonly used in identifying radiographs. If image markers are
placed in regions of direct radiation (saturation), there is a possibility they can be processed out of the
image during image processing. Saturated areas beyond the anatomy are no longer part of the final
image. This is most likely to occur to over exposed images.
In cases where image markers become processed out of the image, users may manually adjust the electronic shutters to include the marker on the final image.
Note: This may cause Detector Exposure Index (DI) result to change. For instructions on how to adjust
the electronic shutter, please refer to Chapter 11: Image Viewer
CAUTIONExercise care when placing image markers to guarantee their presence in the final
image. Every attempt must be made to assure markers are not located in regions
of direct radiation, but are located in regions where some patient attenuation of
radiation is present without obstructing the anatomical information of interest.
iLinq is a system feature, if configured, which allows access to remote service and clinical applications
support.
The iLinq system lets authorized Service Engineers and Applications Specialists, located at GE Healthcare’ Service Support Centers, access X-ray systems (with your permission) to provide the following services:
Faster Emergency Service response
Customer Applications training/support
System troubleshooting and diagnostics
Accumulate system information for failure analysis, resolution and prediction to assist in maintaining
5. Click [CLOSE].
iLinq closes and returns you to the Worklist or Acquisition screens.
Installation and use of the iLinq system is limited to GE Customers with an X-ray system that is under
warranty or covered by a valid GE Service Contract, in accordance with the terms and conditions of the
iLinq Agreement or GE Service Contract. The presence of the GE iLinq system alone, at a your site, does
not provide you any rights or title to the iLinq system or any license or right to access, use or decompile
the iLinq system. Any access to or use of the iLinq system beyond the conditions specified in the iLinq
Agreement or GE Service Contract; or any decompilation of the iLinq system by anyone other than GE
personnel is prohibited. By signing the iLinq Agreement, you agree to use reasonable effort to protect the
iLinq system against damage or loss and to prevent access to, use of or decompilation of the iLinq system by unauthorized personnel.
WARNINGBefore your patient gets on or off the digital table, always press the Table Lock
Control button to block the foot pedal functions momentarily. This avoids injuries
to the patient or damage to the equipment if a foot pedal is accidentally stepped
on.
Figure 5-1 inhibition warning label
Position the Table Longitudinally and Transversely
1. Release the table lock, if necessary.
2. Press the table top positioning foot pedal two consecutive times (“double-tap”). This activates the foot
pedal.
3. Hold the foot pedal down and position the table top.
You can float the table top in all directions while the pedal remains held down.
4. Manually move the tabletop in a longitudinal or transverse direction to the desired position.
5. Release the foot pedal to lock the tabletop.
WARNINGWhen moving the tabletop, be careful of where your and the patient’s fingers are
placed. Do not attempt to move the tabletop without using the foot pedals to
release the longitudinal and transverse movement locks.
WARNINGTo avoid injury to fingers and hand of patient and operator caused by table move-
ment, hands must be kept away from table top edges at all times.