Dynarad Phantom User service manual
Phantom
Portable X-Ray System
Table of
Contents
Safety
Introduction
Installation
Installation, Operation & Service
Manual
Operation
Periodic
Maintenance
Calibration &
Adjustment
Component
Replacement
TroubleShooting
P/N 8000-Phantom
Revision: B, November 8, 2007
Electrical
Schematics
Illustrated
Parts List
Notes
Copyright 2007, Del Medical Systems. All rights reserved.
This document is the property of Del Medical Systems and contains confidential and proprietary
information owned by Del Medical Systems. Any unauthorized copying, use or disclosure of it
without the prior written permission of Del Medical Systemsis strictly prohibited.
Attention: Consult Accompanying Documents - As Applicable
Del Medical Systems Group
50B North Gary Avenue Phone:1-847-288-7000
Roselle, IL 60172 Fax:1-847-288-7011
USA Toll Free:1-800-800-6006
www.delmedical.com
Table of Contents
Chapter i — Safety Information
Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i–1
Statement of Liability. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i–2
Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i–3
Safety Conventions Used in this Manual . . . . . . . . . . . . . . . . . . . . . . . i–4
Warning Statements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i–4
Caution Statements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i–5
Equipment Safety Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i–6
Safety and Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i–9
Radiation Protection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i–10
Maximum Permissible Dose (MPD) . . . . . . . . . . . . . . . . . . . . . . . i–11
Identification Labels. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i–12
Phantom Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i–12
Radiation Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i–13
Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i–13
Manufacturer’s Responsibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i–14
Monitoring Personnel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i–14
Radiation Protection Survey . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i–15
Hazardous Materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i–16
Applicable Standards. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i–17
Chapter ii — Record of Revisions
Revision History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ii–1
Chapter 1 — Introduction
1.1 Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1–1
1.2 Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1–2
1.2.1 Standard Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1–2
1.3 Dimensions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1–3
1.4 Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1–4
1.5 Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1–5
1.6 Accuracy Statements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1–6
kVp. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1–6
mA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1–6
Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1–6
Chapter 2 — Installation
2.1 Assembly Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2–1
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Phantom Installation, Operation and Service Manual
Chapter 3 — Operation
3.1 Safety Precautions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3–1
3.2 Operation Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3–2
3.3 Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3–3
3.3.1 Main Control Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3–3
3.3.2 Miscellaneous Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3–4
3.3.3 Collimator Controls. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3–6
3.4 Operating Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3–7
3.5 Technique Chart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3–12
3.6 Unfolding Phantom . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3–14
3.7 Folding Phantom. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3–19
Chapter 4 — Periodic Maintenance
4.1 Periodic Maintenance Schedule . . . . . . . . . . . . . . . . . . . . . . . . . . . .4–1
4.2 Cleaning External Surfaces . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4–2
4.3 Check fasteners for tightness. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4–3
4.4 Check collimator tightness . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4–4
4.5 Check interconnect cables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4–5
4.6 Check tube head rotation (friction lock) . . . . . . . . . . . . . . . . . . . . .4–6
Chapter 5 — Calibration and Adjustments
5.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5–1
5.2 Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5–2
5.2.1 Equipment setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5–3
5.2.2 Pre-Calibration (only necessary if replacing an X-ray tube)5–3
5.2.3 kVp waveform . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5–4
5.2.4 Beam current (mA) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5–6
5.2.5 Tube potential . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5–7
5.2.6 Exposure time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5–8
5.2.7 X-ray to light field alignment. . . . . . . . . . . . . . . . . . . . . . . . . .5–8
5.3 Adjustments. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5–10
Chapter 6 — Component Replacement
6.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6–1
6.2 Replacing Control Console . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6–2
6.3 Interconnect Cable Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . .6–5
6.4 X-Ray Head Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6–8
6.5 Locking Cylinder Replacement. . . . . . . . . . . . . . . . . . . . . . . . . . . .6–13
6.6 Release Cable Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6–15
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Phantom Installation, Operation and Service Manual
Chapter 7 — Troubleshooting
7.1 Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7–1
7.2 Troubleshooting Index & Charts . . . . . . . . . . . . . . . . . . . . . . . . . . . 7–2
7.3 Schematic Troubleshooting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7–3
7.3.1 Main Control console Layout . . . . . . . . . . . . . . . . . . . . . . . . . 7–4
7.3.2 Generator Layout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7–5
7.4 Technical Theory of Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7–6
7.4.1 System Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7–6
7.4.2 Generator Assembly. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7–6
7.4.3 Control assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7–6
Chapter 8 — Diagrams & Electrical Schematics
8.1 Electrical Schematics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8–1
Chapter 9 — Illustrated Parts List
9.1 Ordering Parts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9–1
9.1.1 To Order by Fax . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9–1
9.2 How to Use This Parts List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9–1
9.2.1 General Part Numbers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9–1
9.3 Commonly Ordered Parts (Collimator) . . . . . . . . . . . . . . . . . . . . . 9–2
9.4 Commonly Ordered Parts (Main Unit) . . . . . . . . . . . . . . . . . . . . . . 9–3
9.5 Overall Assembly (501031) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9–4
9.6 Generator Assembly (500946). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9–6
9.7 Generator Chassis Assembly (500977) . . . . . . . . . . . . . . . . . . . . . . 9–8
9.8 Portable Stand Assembly (500982). . . . . . . . . . . . . . . . . . . . . . . . . 9–10
9.9 Front Leg Assembly (500980). . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9–13
9.10 Tube Arm Assembly (500981). . . . . . . . . . . . . . . . . . . . . . . . . . . . 9–14
9.11 Control Assembly (501020) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9–16
9.12 Control Chassis Assembly (501203). . . . . . . . . . . . . . . . . . . . . . . 9–18
Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . N-1
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Phantom Installation, Operation and Service Manual
4
Safety Information
Introduction
The policy of Del Medical Systems Group is to manufacture X-ray
equipment that meet high standards of performance and reliability. We
enforce strict quality control techniques to eliminate the potential for
defects and hazards in our products.
The intended use of this equipment is to provide an X-ray source for the
purpose of acquiring X-ray images of the desired parts of a patient’s
anatomy. Use of this equipment in any other fashion may lead to serious
personal injury.
i
The safety guidelines provided in this section of the manual are intended
to educate the operator on all safety issues in order to operate and
maintain the Phantom in a safe manner.
Introduction i-1
Phantom Installation, Operation & Service Manual
Statement of Liability
To prevent excess radiation exposure to patient and operator from either
primary or secondary radiation, this Phantom must be operated and
serviced by trained personnel who are familiar with the safety precautions
required. While this Phantom has been designed for safe operation,
improper operation or carelessness may result in serious injury or damage
to equipment. The manufacturer or its agents and representatives assume
no responsibility for the following:
1 Injury or danger to any person from x-ray exposure.
2 Overexposure due to poor technique selection.
3 Injury or danger from improper use of the Phantom function.
4 Problems or hazards resulting from failure to maintain the equipment
as specified in this manual.
5 Equipment which has been tampered with or modified. Del Medical
Systems Group is not liable for any damage or injury arising from
failure to follow the instructions and procedures provided within the
manuals or associated informational material, or from user failure to
use caution when installing, operating, adjusting, or servicing this
equipment. Del Medical Systems Group is not liable for damage or
injury arising from the use of this product for any other use than that
intended by the manufacturer.
i-2 Statement of Liability
Definitions
Phantom Installation, Operation & Service Manual
The table below defines the meaning of various symbols used on labels on
the machine.
This warning symbol is used to indicate a potential hazard to operators, service personnel or equipment. It indicates a requirement to refer to the accompanying
documentation for details.
This symbol indicates that there is accessible dangerous
voltage.
This symbol identifies a protective earth terminal.
This symbol states that this product is categorized as
Type B.
Type B is defined as:
Equipment providing a particular degree of pr ot ec tion
against electric shock, particularly regarding allowable
leakage currents and reliability of the protective earth
connection (if present).
This product contains no field serviceable part s.
Special Cleaning Instructions
One or more of the following regulatory symbols are found on the equip-
ment.
UL Classified Device
Definitions i-3
Phantom Installation, Operation & Service Manual
Warning
Safety Conventions Used in this Manual
Specific safety information is listed in this manual in the form of
WARNING and CAUTION statements. Pay close attention to these
statements - they contain important information on avoiding potential
hazards to you or the equipment.
Warning Statements
• are used to indicate hazards or unsafe practices which COULD result
in severe personal injury or death.
• appear in bold type.
• have a triangular symbol with an exclamation point above the text.
• are preceded by the word Warning.
• are always found before the step or piece of information to which they
refer to.
• look like the following example:
This text will describe special safety precautions to follow in order
to avoid unsafe practices that COULD result in severe personal
injury or death.
i-4 Safety Conventions Used in this Manual
Caution Statements
Caution
• are used to indicate hazards or unsafe practices which could result in
minor personal injury or product or property damage.
• appear in bold type.
• have a triangular symbol with an exclamation point above the text.
• are preceded by the word Caution.
• are always found before the step or piece of information to which they
refer to.
• look like the following example:
This text will describe special safety precautions to follow in order
to avoid unsafe practices that could result in personal injury or
product or property damage.
Phantom Installation, Operation & Service Manual
Safety Conventions Used in this Manual i-5
Phantom Installation, Operation & Service Manual
Warning
Warning
Equipment Safety Guidelines
The following are general safety precautions:
• Do not defeat or bypass built-in equipment safety features.
• Observe all warnings and cautions, stated or implied, in the
procedures.
• Follow all safety labels on the equipment.
The following warnings and cautions are specific to the Phantom. Read
them carefully - some of them are not obvious to typical equipment use.
Do not perform any service procedures on this device until the
power cord has been disconnected and the device has been
allowed to discharge for at least 5 minutes. You can be fatally
shocked if you do not.
Voltage as high as 100,000 volts may be present in the Phantom’s
circuitry for a few minutes after it has been turned off.
All of the movable assemblies and parts of this equipment should
be operated with care and routinely inspected in accordance with
the manufacturer’s recommendations contained in this manual.
Only properly trained and qualified personnel should be
permitted access to any internal parts. Live electrical terminals are
deadly; be sure line disconnect switches are opened and other
appropriate precautions are taken before opening access doors,
removing enclosure panels, or attaching accessories.
For all components of the equipment, protective earthing means
must be provided in compliance with the national regulations.
i-6 Equipment Safety Guidelines
Phantom Installation, Operation & Service Manual
Warning
Warning
Warning
Warning
This Phantom is intended to be used as part of a system for the
intended generation of X-rays for medical diagnosis.
X-rays generate a potential risk for both patients and operators.
For this reason, the application of X-rays for a given medical
purpose must aim at the minimization of radiation exposition to
any persons.
Those persons responsible for the application must have the
specific knowledge according to legal requirements and
regulations and must establish safe exposure procedures for this
kind of systems.
Those persons responsible for the planning and installation of this
equipment must observe the national regulations.
Federal law restricts this device for sale or use by or on order of a
physician or properly licensed practitioner.
Only qualified personnel may operate the Phantom. Operation of
the equipment by persons who have not been trained or who are
unfamiliar with the Phantom may cause serious injury to the
patient, serious injury to the operator, or equipment damage.
The Phantom includes no user serviceable parts. For service
assistance, contact Del Medical.
Equipment Safety Guidelines i-7
Phantom Installation, Operation & Service Manual
Warning
Warning
Warning
Warning
Warning
The Phantom produces ionizing radiation. Operators must meet
all state and local requirements and regulations.
The Phantom and associated cables must not be operated in the
presence of moisture.
The Phantom is rated as Class I Equipment, ensure that the earth
grounding connections between the Phantom and its power source
is maintained at all times.
The Phantom is not suitable for operation in the presence of a
flammable anesthetic mixture with air, oxygen, or nitrous oxide.
Disconnect electrical power from the Phantom before servicing.
Use care not to drop tools or other objects into the Phantom when
working on or around the unit. Electrical shock could result.
i-8 Equipment Safety Guidelines
Safety and Compliance
Exposure to ionizing radiation such as X-rays can be hazardous. United
States federal regulations establish appropriate exposure limits so that the
patient, the operator, and the general public are not unnecessarily being
exposed to such radiation. Personnel operating systems such as the
Phantom must be trained and qualified. They must be familiar with
established regulations and understand the risks associated with the
operation of a X-ray system. They must know what action to take if and
when a hazardous situation arises.
For a more complete understanding of radiological hazards and their
control, X-ray system operators are referred to publications, such as:
Medical X-ray, Electron Beam and Gamma Ray Protection for Energies up
to 50 MeV – Equipment Design, Performance and Use (Report No. 102,
National Council on Radiation Protection)
Medical X-Ray Protection up to Three Million Volts (Handbook No. 76,
National Bureau of Standards/National Institute for Standards and
Technology)
Phantom Installation, Operation & Service Manual
In addition to ionizing radiation, other safety concerns are addressed by
various U.S., Canadian, and international standards. The component parts
and subsystems used in the Phantom have all been tested for compliance
with the safety standards in effect at the time of manufacture in the United
States (UL 187) & Canada (CAN/CSA C22.2 No. 114-M90).
The results of these safety tests and inspections show that the Phantom is
safe. There are, however, certain residual hazards resulting from the
mechanical articulation of the system. Minimizing the risk of injury to the
patient and to the operator resulting from these residual hazards requires
care and alertness at the time of installation. Pinch points are labeled as
appropriate at the time of installation. These labels must not be removed.
If they become soiled or damaged, they need to be replaced.
Safety and Compliance i-9
Phantom Installation, Operation & Service Manual
Radiation Protection
Serious unfavorable health effects can result from short term exposure to
high levels of ionizing radiation (such as X-rays) as well as from long term
exposure to low levels. Personnel who operate the Phantom should
familiarize themselves with both the short term and the long term effects
of radiation exposure and take appropriate measures to minimize the
amount of radiation to which they are exposed while performing their
duties. Some effects of X-ray radiation are cumulative, and may extend
over a period of months or years. The best safety rule for X-ray operators
is to avoid exposure to the primary beam at all times.
Ionizing radiation occurs naturally in the environment. It is generated by
astronomical radiation sources such as the sun and the stars, and by the
soil under our feet. The atmosphere filters radiation from astronomical
sources. As a result, the radiation level from these sources is much lower
at sea level than on the summit of high mountains. Radiation generated in
the soil varies greatly from place to place depending on the composition of
the soil. For example, areas rich in granite rock have a higher level of
radiation than other areas.
Any materials placed in the path of the beam absorb natural as well as
man-made radiation, such as the X-rays used in the Phantom. Materials
with a high atomic number, such as tungsten, lead, and uranium, absorb
X-rays much more effectively than materials with a low atomic number
such as hydrogen, aluminum, or beryllium. Therefore, lead is used for
shielding the radiologist's workstation in most X-ray facilities, including
ones using the Phantom. If there are windows in the partition separating
the operator from the patient, these windows are typically glazed with
lead glass and provide effective protection against ionizing radiation.
To minimize dangerous exposure, use movable lead screens,
lead-impregnated gloves, and lead-impregnated aprons. These protective
devices must contain 0.25 millimeter thickness of lead or the equivalent.
Use such protective devices for all operators, observers, and/or servicing
personnel exposed to radiation fields of five or more milli-Roentgens per
hour.
The shielding provided for a typical X-ray facility's operator workstation
is generally quite effective and reduces the residual radiation from
diagnostic X-rays to a level that is comparable to or lower than natural
background radiation. If the operator abandons the protected
environment of the workstation, he or she may be exposed to a
significantly higher level of radiation. For a single exposure this may still
not lead to serious health effects, but repeated carelessness in this regard
may lead to serious consequences.
Any object in the path of the primary beam produces scattered radiation.
In the absence of proper precautions, scattered radiation can result in a
i-10 Radiation Protection
substantial radiation dose to the operator or any other personnel in the
facility. Moveable screens may be used to shield occupied areas from
scattered radiation.
The X-ray Generator/host system used to power the Phantom only
produces X-rays when high voltage is applied to the X-ray tube. When the
high voltage is removed, X-ray emission ceases without delay.
Maximum Permissible Dose (MPD)
Various studies of the effects of x-ray radiation have provided a
foundation for establishing the maximum permissible does (MPD) of xray radiation. The results of these studies have been used by the NCRP
and the ICEP to develop recommendations for MPD.
ICRP recommends that the MPD to the most critical organs (heart, lungs,
liver, kidney, brain, etc.) accumulated at any age shall not exceed five
rems multiplied by the number of years beyond 18:
Phantom Installation, Operation & Service Manual
M PD = 5 X (N - 1 8) rems where n age in years
However, in no case shall the exposure exceed three (3) rems in any period
of 13 consecutive weeks.
For hands, forearms, feet and ankles, the recommended MPD is 75 rems in
any one year.
Radiation Protection i-11
Phantom Installation, Operation & Service Manual
(on the bottom of the
tube head in between
the tube head and the
collimator)
(on the bottom of
the control console)
Identification Labels
The Phantom components have manufacturing and certification
information affixed. The manufacturing label contains:
• The full name and address of the manufacturer of the component
• The place, month, and year of manufacture
• The model number and serial number of the component
The certification label also states that the component complies with either
“21CFR, Subchapter J”, or the applicable DHHS standards under the
Radiation Control for Health and Safety Act of 1968 (or its equivalent).
A label may combine both manufacturing and certification information.
Phantom Labels
The location of each Phantom identification label is shown in Figure i-1.
i-12 Identification Labels
Figure i-1. Phantom Identification Labels
Radiation Safety
Warning
Caution
Safety
Everyone associated with X-ray work must be familiar with the
recommendations of the Center for Devices and Radiological Health
(CDRH), the National Institute for Standards and Technology (NIST), the
National Council on Radiation Protection (NCRP), and the International
Committee on Radiation Protection (ICRP).
Be sure that all personnel authorized to operate the X-ray system are
familiar with the established regulations of the authorities named above.
All personnel should be monitored to ensure compliance with
recommended procedures.
Current sources of information include:
• National Council on Radiation Protection Report No. 33
(“Medical X-ray and gamma ray Protection for Energies up to
10 MEV-Equipment Design and Use”).
Phantom Installation, Operation & Service Manual
• National Bureau of Standards Handbook No. 76 (“Medical X-ray
Protection up to Three Million Volts”). Refer to NCRP Report No. 33.
• Current recommendations of the International Committee on
Radiation Protection.
Although X-ray radiation is hazardous, X-ray equipment does not pose
any danger when properly used. Be certain all operating personnel are
properly educated concerning the hazards of radiation. Persons
responsible for the system must understand the safety requirements and
special warnings for X-ray operation. Review this manual and the
manuals for each component in the system to become aware of all safety
and operational requirements.
Ensure exposure parameters are properly adjusted within safety
limits.
Incorrectly positioning the X-ray tube and Collimator could cause
the X-ray field to be misaligned with the bucky, resulting in
unacceptable images.
Radiation Safety i-13
Phantom Installation, Operation & Service Manual
Manufacturer’s Responsibility
Although this equipment incorporates protection against X-ray radiation
other than the useful beam, practical design does not provide complete
protection. Equipment design does not compel the operator or assistants
to take the necessary precautions; nor does it prevent the possibility of
improper use (authorized or unauthorized persons carelessly, unwisely,
or unknowingly exposing themselves or others to direct or secondary
radiation). Allow only authorized, properly trained personnel to operate
this equipment.
Be certain that all individuals authorized to use the equipment are aware
of the danger of excessive exposure to X-ray radiation.
This equipment is sold with the understanding that the manufacturer, its
agents, and representatives, do not accept any responsibility for
overexposure of patients or personnel to X-ray radiation.
Furthermore, the manufacturer does not accept any responsibility for
overexposure of patients or personnel to X-ray radiation generated by the
equipment used in conjunction with the Phantom components as a result
of poor operating techniques or procedures.
No responsibility is assumed for any unit that has not been serviced and
maintained in accordance with the technical service manual, or which has
been modified or tampered with in any way.
Monitoring Personnel
Monitoring 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. This cross-check may reveal
inadequate or improper radiation protection practices and/or serious
radiation exposure situations.
The most effective method of determining whether the existing protective
measures are adequate is the use of instruments to measure the exposure
(in rads). This measurement should be taken at all locations where the
operator, or any portion of the operator’s body, may be inadequately
shielded during exposure. Exposure must never exceed the accepted
tolerable dose.
A frequently used, but less accurate, method of determining the amount of
exposure is placement of film at strategic locations. After a specified
period of time, develop the film to determine the amount of radiation.
Fluorescent screens (used in a darkened room) may also be used to detect
excessive radiation.
i-14 Manufacturer’s Responsibility
A common method of determining whether personnel have been exposed
Warning
to excessive radiation is the use of film badges. These are X-ray sensitive
film enclosed in a badge that incorporates metal filters of varying degrees
of transparency to X-ray radiation. Even though this device only measures
the radiation reaching the area of the body on which it is worn, it does
provide an indication of the amount of radiation received.
Radiation Protection Survey
A radiation protection survey must be made by a qualified expert after
every change in equipment or change in operating conditions which
might significantly increase the probability of personnel receiving more
than the maximum permissible dose equivalent.
Restrictions on Use
Phantom Installation, Operation & Service Manual
Do not install components or accessories that were not intend for
use by the system. Failure to comply could result in damage to the
equipment or injury to personnel.
The user is responsible for ensuring that the application and use of the
Phantom does not compromise the patient contact rating of any
equipment used in the vicinity of, or in conjunction with, the system.
The use of accessory equipment and/or hardware not complying with the
equivalent product safety and EMC requirements of this product may
lead to a reduced level of safety and/or EMC performance of the resulting
system. Consideration relating to the choice of accessory equipment used
with this product shall include:
• The use of the accessory in the patient vicinity
• Evidence that the safety certification of the accessory has been
performed in accordance with the appropriate IEC 60601-1 and/or
IEC 60601-1-1 Harmonized National Standards
Some components of the Phantom have been classified as to acceptable
applications of use in accordance with Information Technology
Equipment regulations such as EN60950.
Radiation Protection Survey i-15
Phantom Installation, Operation & Service Manual
Caution
Observe all safety precautions recommended by the accessory
equipment manufacturer in the user documentation provided with
the equipment.
The hardware specified for use with the Phantom has been selected,
tested, and verified by Del Medical to meet the intended applications. All
specified hardware meets applicable regulatory agency requirements for
those countries where it is offered for sale with respect to its intended
applications. Consult the user documentation included with the
equipment for specific information relating to product safety and EMC
compliance.
Hazardous Materials
The collimator used with the Phantom contains lead. Refer to the manual
provided with the collimator for additional information regarding
hazardous materials.
i-16 Hazardous Materials
Applicable Standards
This X-ray generator complies with the following regulatory requirements
and design standards:
FDA 21 CFR Subchapter J, UL187 & CAN/CSA C22.2 No. 114-M90.
Type of protection against electric shock: Class I
Degree of protection against electric shock is Type B Applied Parts.
Degree of protection against harmful ingress of water: IPXO.Ordinary
Mode of Operation: 0.5% Duty Cycle.
Equipment not suitable for use in the presence of flammable anesthetic
mixture with air, oxygen or nitrous oxide.
Degree of protection against electric shock is Type B applied part.
The equipment is intended to be used as a mobile X-ray generator in a
mobile or stationary radiographic diagnostic X-ray configuration.
Phantom Installation, Operation & Service Manual
Applicable Standards i-17
Phantom Installation, Operation & Service Manual
i-18 Applicable Standards
Record of Revisions
Revision History
REV Date Reason for Change
A 6-15-06 Original
B 10-2-07 Chapter 1: Line Volt Regulation added to Specifications
Chapter 3: Line Volt Regu lation added to Specifications, start-up
indications added
Chapter 4: items added to periodic maintenance
Chapter 5: calibration added
Chapter 6: instructions to remove control console back cover
added, X-Ray tube head replacem. procedure changed
Chapter 7: schematics removed (ref. to chapter 8)
Chapter 8: rev. level column added to table, schematics revised
Throughout the manual: uniform terminology
ii
Table ii-1. Revision History
Revision History ii-1
Phantom Installation, Operation & Service Manual
ii-2
Introduction
Collimator
Maneuvering
Control &
X-Ray Tube Head
Exposure Handswitch
Locking Cylinder
Cassette
Wheel
Storage
Display
Console
Handles
Brakes
Front Leg
Assembly
SID Tape
Measure
Lev-O-Gage
Source to Skin Distance
(Do not Use as Handles)
Tube Arm
1.1 Introduction
This manual provides installation, operation and service information for
the Phantom Portable X-Ray System. This manual also includes a spare
parts list for the system.
1
Figure 1-1. The Phantom Portable X-Ray System
Introduction 1-1
Phantom Installation, Operation & Service Manual
1.2 Description
The DynaRad Phantom is a portable and rugged x-ray system that
provides high-quality x-ray images at an affordable price.
The Phantom can retract into a small, self-contained package that can be
easily transported and set up in the most demanding environments.
And it’s easy to maneuver and operate.
1.2.1 Standard Features
• 1.25 Kilowatt X-Ray Generator
• Tape Measure for SID Distance
•Inclinometer
• Detachable, Two-Stage Handswitch
• 30-Second Timer on Collimator Lamp
• Digital Displays on Membrane Switch Control Panel
• Manually Controlled Certified Collimator
• Pneumatic Rear Tires
• Spring-Loaded Counter Weight Ram to Ease Positioning of X-Ray
Tube
1-2 Description
1.3 Dimensions
HIGHFREQUENCYX-RAYSYSTEM
WARNING:
SAFEEXPOSUREFACTORSANDOPERATINGINSTUCTIONS AREOBSERVED.NSTUCTIONS AREOBSERVED.
THIS X-RAYUNITMAY BEDANTMAYBEDANGEROUSTOPATIENTANDOPERATOR,UNLESS
MADE INMADE
INU.S.A.
RESET
FAULT
0.01-4.00sec.50-100kVp
TimemAskVp
12.5mA
X-RAY
READY
C.L.
4.0”
78”
43”
36”
25”
52”
21”
55”
27”
(198cm)
(91.4cm)
(140cm)
(109cm)
(53cm)
(10cm)
(69cm)
(64cm)
(132cm)
Phantom Installation, Operation & Service Manual
Figure 1-2. Dimensions
Dimensions 1-3
Phantom Installation, Operation & Service Manual
1.4 Specifications
Specifications
Voltage 104-126VAC/ 208 - 253 VAC
Line Voltage Regulation 5% maximum at maximum output
Current 30 Amps Maximum Momentary @ 115VAC
Requires 30 amp or greater dedicated breaker or line fuse.
18 Amps Maximum Momentary @ 230VAC
Requires 18 amp or greater dedicated breaker or line fuse.
Frequency 50/60 Hz Single Phase
Generator Type High frequency inverter, 1.25 kilowatt output
kVp Range 50-100 kVp continuously adjustable, with 1 kVp resolution
mA Range Fixed, 12.5 mA, constant independent of kVp or time settings
Exposure Time 0.01 to 4.0 seconds in 96 increments
X-Ray Tube Stationary Anode 100 kVp
Filtration 3.6 mm Aluminum Equivalent or More @ 100kVp
Target Material Tungsten
Anode Capacity 25,000 Heat Units
Focal Spot 1.0 mm (NEMA)
Beam Angle 15°
Collimator Certified Manual
Collimator Lamp Source 30 second timer
Duty 3.3%
Mode of Operation Momentary
Relative Humidity Limits Transit/Storage
10% to 100%
Operating
10%-80% Non-Condensing
Atmospheric Limits 14.5 inHg to 30.74 inHg
500 hPa to 1060 hPA
W eight 95 lbs (42 Kg) Total/ X-Ray Generator 39lbs (17.7 kg)/Control
Console (7 lbs (3.2kg)
Certifications:
Equipment not suitable for use in the presence of flammable anesthetic mixtures with air, oxygen or nitrous
oxide.
No user serviceable parts
Classified To UL 187. Certified To
114-M90
.
CAN/CSA C22.2 No.
1-4 Specifications
Table 1-1: Specifications
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