Carestream Health DRXRGA Safety and Regulatory Manual
DRX-Revolution Mobile X-ray
System
Safety and Regulatory Information
2012-02-07
9J0239
Version 3.0
Table of Contents
1 Safety and Regulatory Information
Manual Conventions............................................................................................................................................ 1
Overview ............................................................................................................................................................. 1
Indications for Use........................................................................................................................................ 2
Training ........................................................................................................................................................ 2
Safety and Related Information............................................................................................................................ 3
Manufacturer’s Responsibility ....................................................................................................................... 3
Safety Symbols............................................................................................................................................... 4
Radiation and X-ray System ........................................................................................................................... 6
Safety and General Compliance Information............................................................................................ 6
Maximum Permissible Dose (MPD)........................................................................................................ 7
Radiographic Performance ..................................................................................................................... 7
Radiation Protection ............................................................................................................................... 8
CDRH Compliance................................................................................................................................... 9
Classification in Accordance with IEC 60601-1........................................................................................ 9
IEC/EN 60601-1-3 Compliance................................................................................................................ 9
Conforming Safety Standards....................................................................................................................... 10
USA ....................................................................................................................................................... 10
Canada.................................................................................................................................................. 10
Europe.................................................................................................................................................. 10
International ......................................................................................................................................... 10
Cautions............................................................................................................................................................ 11
Equipment Cautions .............................................................................................................
Electrical/Mechanical.................................................................................................................................. 11
Mechanical ................................................................................................................................................. 11
General Use Cautions and Special Messages ................................................................................................ 11
Moving and Equipment Use Cautions........................................................................................................... 12
Electrical and Flammable Cautions.............................................................................................................. 12
Radiation and Magnetic Field Cautions........................................................................................................ 13
Cleaning Cautions........................................................................................................................................ 13
Caution Regarding Small-Object Image Handling ........................................................................................14
Restrictions on Use ..................................................................................................................................... 15
....................... 11
9J0239 1
Disposal............................................................................................................................................................ 16
Usability............................................................................................................................................................ 16
USB, Network, and Tether Connectors .............................................................................................................. 17
Conforming EMC Standards .............................................................................................................................. 18
For European Market Only.......................................................................................................................... 18
System Requirements.................................................................................................................................. 18
US and Canada EMC Statements .................................................................................................................. 19
Electromagnetic Emissions/Immunity ......................................................................................................... 20
Wireless............................................................................................................................................................ 28
DRX-Revolution Wireless Systems ............................................................................................................... 28
DRX-1 and DRX-1C System Detectors.................................................................................................... 28
Grid Alignment Transmitter................................................................................................................... 28
Wireless Compliance Information for EU Directive 1999/5/IEC................................................................... 29
Grid Alignment Intended Use ................................................................................................................ 29
EC Declaration of Conformity............................................................................................................................ 30
National Usage Restrictions......................................................................................................................... 31
Compliance................................................................................................................................................. 32
Anti-Collision Feature........................................................................................................................................ 35
Patient Vicinity .................................................................................................................................................. 35
Compatible Components ................................................................................................................................... 35
X-ray Tube Components.............................................................................................................................. 35
X-ray Source Assembly................................................................................................................................ 35
Accessories................................................................................................................................................. 36
Flammability ............................................................................................................................................... 36
Method of Cleaning..................................................................................................................................... 36
Extra Focal Dimensions .................................................................................................................................... 37
Labels ............................................................................................................................................................... 39
Systems Label Locations.............................................................................................................................. 39
Detector /Grid Holder Weight Limit Label ................................................................................................... 41
Product Disclosure Table.................................................................................................................................. 42
29J0239
Safety and Regulatory Information
CAUTION:
1
Safety and Regulatory
Information
The information contained herein is based on the experience and knowledge
relating to the subject matter gained by Carestream Health, Inc. prior to
publication.
No patent license is granted by this information.
Carestream Health, Inc. reserves the right to change this information without
notice, and makes no warranty, express or implied, with respect to this
information. Carestream Health shall not be liable for any loss or damage,
including consequential or special damages, resulting from any use of this
information, even if loss or damage is caused by Carestream Health’s
negligence or other fault.
Manual Conventions
NOTE: The original documentation is written in English.
Overview
This manual uses three types of messages to emphasize information or
potential risks to personnel or equipment: Note, Important and Caution.
NOTE: Notes provide additional information, such as expanded
explanations, hints, or reminders.
IMPORTANT: Important highlights critical policy information that
affects how you use this manual and this product.
Cautions point out procedures that you must follow precisely
to avoid injury to yourself, others, damage to the system or any
of its components, loss of data, or corruption of files in
software applications. Disregarding the caution statement may
lead to abnormal use.
The CARESTREAM DRX Mobile X-ray System is a mobile imaging system that
incorporates a self contained X-ray generator, image receptor, imaging
display and software for acquiring medical diagnostic images outside a
standard X-ray room. It is a mobile diagnostic system intended to generate
and control X-rays for examination of various anatomical regions.
1-1 9J0239
Safety and Regulatory Information
CAUTION:
CAUTION:
The system is designed for use in all locations of a hospital or clinical site,
including patient rooms, operating rooms, emergency departments, trauma
bays, Intensive Care Units (ICU) and other patient treatment areas.
Personnel operating and maintaining the System should receive training and
be familiar with all aspects of operation and maintenance. To ensure safety,
read the Safety Information section carefully before using the system and
observe all Cautions, Importants, and Notes located throughout this
manual and other manuals supplied with the equipment.
From this point forward, all references to the DRX -Revolution System will be
referred to as the System.
Indications for Use The device is designed to perform radiographic X-ray examinations on all
pediatric and adult patients, in all patient treatment areas.
Training This equipment is intended for use by appropriately trained and skilled
radiological health care professionals who have received specific training on
the operation and use of this equipment.
Only qualified personnel may operate the System. Operation of
the equipment by persons who have not been trained or who
are unfamiliar with the functions and controls of the System
may cause serious injury to the patient, serious injury to the
operator, or equipment damage.
Only allow trained X-ray personnel to operate the system.
For training in the operation of this equipment, contact Carestream Health,
Inc.
1-2 9J0239
Safety and Regulatory Information
Safety and Related Information
Manufacturer’s
Responsibility
Although this equipment incorporates protection against X-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-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-radiation.
Furthermore, the manufacturer does not accept any responsibility for
overexposure of patients or personnel to X-radiation generated by this
equipment 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 that has been
modified or tampered with in any way.
1-3 9J0239
Safety and Regulatory Information
~
Safety Symbols The following symbols may be used for marking on this equipment for
equipment documentation.
Emergency Stop button
Follow operating instructions
Warning—dangerous voltage
Dangerous voltage
Warning— ionizing radiation
Type B applied part
Direct current
Alternating current
Collimator light
1-4 9J0239
Safety and Regulatory Information
Power Off
Power On
Equipment Off
Equipment On
Caution
Non-ionizing radiation
Tether cable
Ethernet connection
USB connection
1-5 9J0239
Safety and Regulatory Information
CAUTION:
CAUTION:
CAUTION:
Radiation and X-ray
System
Safety and General
Compliance
Information
Occupational workers associated with X-ray work must be familiar with the
recommendations of the Center for Devices and Radiological Health (CDRH),
the National Council on Radiation Protection (NCRP), the International
Commission on Radiation Protection (ICRP), and state and local regulations.
Be sure that all personnel authorized to operate the 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:
• NCRP Report 147: Structural Shielding Design for Medical Imaging
Facilities
• Current recommendations of the International Committee on Radiation
Protection
• State or local requirements for radiation protection
Although exposure to high levels of X-radiation may pose a health risk, System
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 operation requirements.
Ensure exposure parameters are properly adjusted within
safety limits.
Incorrect Collimator adjustment may cause unnecessary
patient X-ray exposure. See the DRX-Revolution Mobile X-ray
System Hardware Guide for instructions for adjusting the size
of the exposure area.
Incorrect X-ray Tube and Collimator position could cause the
X-ray field to be misaligned with the receptor, resulting in
unacceptable images.
1-6 9J0239
Safety and Regulatory Information
CAUTION:
Materials between the Tube and the patient may adversely
affect the resulting image.
Maximum Permissible
Dose (MPD)
Various studies on the effects of X-radiation have provided a foundation for
establishing the maximum permissible dose of X-radiation to which an
occupational worker may be exposed. The results of these studies have been
used by the NCRP and the ICRP to develop recommendations for MPD. In
addition, state or local regulators also provide occupational exposure limits
which must be complied with.
Occupational Exposure Limits:
Whole body: 5.0 rem/year
Extremity: 50.0 rem/year
Declared pregnant occupational worker: 0.5 rem/gestation period
Radiographic
Performance
kVp Range 40 to 150 kVp
kVp Accuracy ±(5 % + 1) kVp, measured 5 ms after the beginning of the exposure; ±2 % between
70–85 kVp
Ripple (kVp) ±5 % p–p over the full operating range (for ripple frequency kHz
Risetime (10– 90 %) < 2.0 ms (typically < 1.5 ms)
mAs Accuracy ±(10 % + 0.20) mAs: > 0.5 mAs
± (10 % + 0.5 mAs: 0.1 mAs–0.5 mAs
Coefficient of linearity 0.1 (Station to Station) for exposures mor 3.2 ms
Coefficient of
< 0.05 for kVp and mAs parameters
Reproducibility
1-7 9J0239
Safety and Regulatory Information
Radiation Protection Because exposure to high levels of X-radiation may pose a health risk,
operators must ensure that they use all available methods to reduce their
radiation dose to a level that is As Low As Reasonably Achievable (ALARA).
This includes protection from the primary beam as well as scattered
radiation. Protection from excessive amounts of exposure is accomplished
using a combination of engineering and administrative controls.
• Portable Barriers and Lead Aprons—Portable barriers and lead
aprons may be needed to protect personnel from scattered radiation if
operators need to be in close contact with the patient. Make sure that the
shielding and aprons have sufficient lead equivalence, as determined by a
qualified Health or Medical Physicist, and are maintained properly for
maximum benefit.
• Procedures—Always follow the procedures of your institution to ensure
proper protection.
• Training—Medical equipment should be operated by trained personnel
only. Most regulatory agencies require that medical diagnostic procedures
be done only by properly licensed individuals. Consult your state or local
agencies for more information.
• Radiation Survey—Monitor the exterior of the X-ray facility (outside the
primary protective barrier) and control room periodically to ensure that
dose rates meet design objectives for allowable radiation exposures. A
qualified Health or Medical Physicist should use only calibrated equipment
for this survey.
• Personal Monitoring—Monitor occupational workers that use X-ray
equipment for X-ray exposure to ensure that established controls are
functioning properly and procedures are being followed. Typically, film
badges or similar devices are used. Film badges use X-ray sensitive film
enclosed in a holder 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 provides an
indication of the amount of radiation received. Film badges can also be
used as area dosimeters on the outside perimeter of the X-ray facility and
control room to verify dose rates.
Film badges are available from a number of distributors. Consult your
institution’s Radiation Safety Officer for further information.
IMPORTANT: Use a source-to-skin distance as large as possible to keep
the absorbed dose as low as reasonably achievable. The
Operator Console must be located where there is audio and
visual communication between the radiographer and the
patient.
1-8 9J0239
Safety and Regulatory Information
CDRH Compliance The X-ray System complies with Department of Health and Human Services
radiation performance standards per Title 21 CFR, Chapter 1, Subchapter J,
Section 1020.
Classification in
Accordance with
IEC 60601-1
Type of protection against electrical shock Class I equipment/Internally powered
Degree of protection against electrical shock Type B protection against electrical shock
Degree of protection against ingress of water Ordinary protection
Mode of operation Continuous operation with intermittent loading
Flammable anesthetics Not suitable for use in the presence of flammable anesthetics
or a mixture of flammable anesthetics with air or oxygen or
nitrous oxide
IEC/EN 60601-1-3
Compliance
Electrical Rating
The System is manufactured with radiation protection in accordance with
IEC/EN 60601-1-3:1994.
DRX-Revolution Mobile X-ray System Voltage: 100/120/200/240/ VAC
Current: 4.4/12.0/7.2/6.0 A
Frequency: 50/60 Hz
DRX-Revolution Grid Holder Voltage: 3.2 VDC
Current: 1.5 A
CARESTREAM DRX-1/DRX-1C System Detector Voltage: 3.2 VDC
Current: 3.0 A
1-9 9J0239
Safety and Regulatory Information
Conforming Safety
Standards
USA UL 60601–1:2003 Medical Electrical Equipment, Part 1: General
Requirements for Safety
Canada CAN/CSA–C22.2 No. 601.1–M90—Medical Electrical Equipment—Part 1:
General Requirements for Safety
Europe EN 60601–1:1990 + A1+ A2—Medical Electrical Equipment—Part 1:
General Requirements for Safety
EN 60601–1–1:2001—Medical Electrical Equipment—Part 1–1: General
requirements for safety —Collateral standard: Safety requirements for
medical electrical systems
EN 60601–1–3:1994—Medical Electrical Equipment—Part 1–3: General
requirements for safety—3. Collateral standard: General requirements for
radiation protection in diagnostic X-ray equipment
EN 60601–1–4:1996 +A1—Medical Electrical Equipment—Part 1–4:
General requirements for safety—Collateral standard: Programmable
electrical medical systems
EN 606011–6:2004—Medical Electrical Equipment—Part 1–6: General
requirements for safety—Collateral standard: Usability
EN 60601–2–32:1994—Medical Electrical Equipment—Part 2–32:
Particular requirements for the safety of associated equipment of X-ray
equipment
International IEC 60601–1:1988 + A1 + A2—Medical Electrical Equipment—Part 1:
General Requirements for Safety
IEC 60601–1–1:2000—Medical Electrical Equipment—Part 1–1: General
requirements for safety—Collateral standard: Safety requirements for
medical electrical systems
IEC 60601–1–3:1994—Medical Electrical Equipment—Part 1–3: General
requirements for safety —3. Collateral standard: General requirements for
radiation protection in diagnostic X-ray equipment
IEC 60601-1-4:1996 +A1—Medical Electrical Equipment—Part 1–4:
General requirements for safety—Collateral standard: Programmable
electrical medical systems
IEC 60601-1-6:2004 - Medical Electrical Equipment—Part 1–6: General
requirements for safety—Collateral standard: Usability
IEC 60601–2–32:1994—Medical Electrical Equipment—Part 2-32:
Particular requirements for the safety of associated equipment of X-ray
equipment
1-10 9J0239
Safety and Regulatory Information
CAUTION:
CAUTION:
Cautions
Equipment Cautions The following are general safety precautions:
• Do not remove the covers for any purpose.
• Do not defeat or bypass built-in equipment safety features.
• Observe all cautions, stated or implied, in the procedures.
• Follow all safety labels on the equipment.
Do not attempt any repairs if the equipment fails to operate
correctly. Immediately call a person qualified and authorized
to repair the equipment.
Electrical/Mechanical
Only a qualified authorized Service Provider should replace
electrical and mechanical components.
Mechanical The following are mechanical safety precautions:
• Keep fingers, hands, and tools clear of moving parts.
• Do not operate the equipment with covers or access panels removed.
• Route cables properly to eliminate hazards from tripping.
General Use Cautions
and Special Messages
9J0239 1-11
Loading...