AGFA dxd-100 User Manual
DX-D 100 Mobile X-Ray Unit
User Manual
Technical Publication
0188K EN 20201116
DX-D 100 Mobile X-ray Unit
User Manual
REVISION HISTORY
REVISION DATE REASON FOR CHANGE
A JUL 06, 2010 First edition
B JUN 10, 2011 General Update and DR Detector options
C MAY 27, 2013 IEC Standards; DR Detector options; Battery
Charge Level Indicators
D NOV 21, 2013 Displacement Controls Update and Collimator
E JAN 29, 2015 Telescopic Column (Option); Lead-Crystal Batteries;
Displacement Controls; Storage Bin for Wireless
configuration; Factors: Power Line Operation,
Maximum Input Power, Battery Capacity, Maximum
Symmetrical Radiation Field, Environmental
Conditions; General Update
F JUL 30, 2015 Designated Significant Zones of Occupancy,
Distribution of Stray Radiation; Control Panel:
ON/OFF Keypad for Access Control (Option);
Additional Features: Bluetooth (Option), LED Beacon
Light, Tube Rotation Indicators; Advisory Indications
in Section 3.8 of Motion Controls; Information for
Collimator Rotation; Configuration for Wireless DR
Detectors Options, Integrated Battery Charger;
Weight for Mobile units with Standard Column;
Illustrations, Pictures and General Update
G OCT 05, 2016 General Update
H SEP 20, 2018 New Label; Intended Use, IEC Standards Update;
General Cautions; Removed information for Gel
Batteries; Hand-grips Support (option); New Storage
Bin; New Detectors; Back-up Cable and Illustrations
I NOV 13, 2019 Mains Connection and Line Circuit Breaker; Manual
Clutch Screws; Parking Position of the Arm;
Collimator Controls, Dosimetry, Optional Wired
Configuration for some Wireless DR Detectors and
Illustrations
J MAY 22, 2020 Battery Charge Level Indicators; AppendixesA and B
and GeneralUpdate
K
This Document is the English original version, edited and supplied by the manufacturer.
The Revision state of this Document is indicated in the code number shown at the bottom of this page.
0188K EN 20201116
NOV 16, 2020 Displacement Controls
DX-D 100 Mobile X-ray Unit
User Manual
ADVISORY SYMBOLS
The following advisory symbols will be used throughout this manual. Their
application and meaning are described below.
DANGERS ADVISE OF CONDITIONS OR SITUATIONS THAT
IF NOT HEEDED OR AVOIDED WILL CAUSE SERIOUS
PERSONAL INJURY OR DEATH.
ADVISE OF CONDITIONS OR SITUATIONS THAT IF NOT
HEEDED OR AVOIDED COULD CAUSE SERIOUS PERSONAL
INJURY, OR CATASTROPHIC DAMAGE TO EQUIPMENT
OR DATA.
Advise of conditions or situations that if not heeded or
avoided could cause personal injury or damage to equipment
or data.
Note . Alert readers to pertinent facts and conditions. Notes represent
information that is important to know but which do not necessarily
relate to possible injury or damage to equipment.
0188K EN 20201116
DX-D 100 Mobile X-ray Unit
User Manual
TABLE OF CONTENTS
Section Page
1 INTRODUCTION 1.........................................................
1.1 General Features 4...................................................
1.2 Product Identification 5................................................
1.3 Indications for Use 6..................................................
1.3.1 Intended Use 6................................................
1.3.2 Normal Use 6.................................................
1.3.3 Contraindications 6............................................
2 SAFETY AND REGULATORY INFORMATION 7..............................
2.1 General 7...........................................................
2.2 Responsibilities 10.....................................................
2.3 Maximum Permissible Dose (MPD) 1 1...................................
2.4 Radiation Protection 12.................................................
2.5 Monitoring of Personnel 14.............................................
2.6 Safety Symbols 15.....................................................
2.7 Regulatory Information 20..............................................
2.7.1 Certifications 20................................................
2.7.2 Environmental Statement on the Life Cycle of the Equipment
or System 20...................................................
2.7.3 Mode of Operation 20...........................................
2.7.4 Protection against Electric Shock Hazards 21.......................
2.7.5 Protection against Harmful Ingress of Water or Particulate Matter 21...
2.7.6 Protection against Hazards of Ignition of Flammable
Anaesthetic Mixtures 21.........................................
2.7.7 Protection against Hazards from Unwanted or Excessive Radiation 21.
2.7.8 Designated Significant Zones of Occupancy 22.....................
2.7.9 Distribution of Stray Radiation 24.................................
2.8 Electromagnetic Compatibility (EMC) 27..................................
2.9 Quantitative Information 35.............................................
2.9.1 Functional Tests Performed to Obtain the Quantitative Information 35..
2.10 Deterministic Effects 37................................................
0188K EN 20201116 i
DX-D 100 Mobile X-ray Unit
User Manual
Section Page
3 GENERAL AND MOTION CONTROLS 39.....................................
3.1 Mains Connection and Line Circuit Breaker 42.............................
3.2 Control Panel 43......................................................
3.2.1 ON / OFF Control 43............................................
3.2.2 Emergency Stop 44.............................................
3.2.3 Power Line Connection Lamp 44..................................
3.2.4 Collimator Lamp 44.............................................
3.2.5 Battery Charge Level Indicators 45................................
3.3 Peripheral Connections - CD/DVD 47....................................
3.3.1 Configuration with Wireless DR Detector 47........................
3.3.2 Configuration with Portable DR Detector 47........................
3.4 Control Console 47....................................................
3.5 X-ray Handswitch 48...................................................
3.6 Infrared Remote Control (optional) 49....................................
3.6.1 Operation 50...................................................
3.6.2 The “Remote Finder” Device 50...................................
3.7 LED Beacon Light (option) 50...........................................
3.8 Motion Controls 51....................................................
3.8.1 Displacement Controls 53........................................
3.8.2 Parking Position of the Arm 58...................................
3.8.3 Movement Controls of the Column and Telescopic Arm 59............
3.9 Collimator Controls 61..................................................
3.10 Dosimetry (optional) 62.................................................
3.11 DR Detector 63.......................................................
3.11.1 Configuration for Wireless DR Detectors 63........................
3.11.2 Configuration for Portable DR Detectors 67........................
3.11.3 General Use and Maintenance of Digital Detectors, Options
and Accessories 68.............................................
ii
0188K EN 20201116
DX-D 100 Mobile X-ray Unit
User Manual
Section Page
4 OPERATING SEQUENCES 69...............................................
4.1 X-ray Tube Warm-up Procedure 69......................................
4.2 Radiographic Operations 70............................................
4.3 X-ray Beam Alignment with Respect to Patient 70..........................
5 PERIODIC MAINTENANCE 73..............................................
5.1 Operator Tasks 73.....................................................
5.1.1 Batteries Maintenance 73........................................
5.1.2 Periodic Maintenance 74.........................................
5.1.3 Cleaning and Disinfection 75.....................................
5.2 Service Tasks 75......................................................
6 TECHNICAL SPECIFICATIONS 77...........................................
6.1. Factors 77............................................................
6.2 X-ray Tubes 79........................................................
6.3 Physical Characteristics: Mobile with Wireless DR Detector 80...............
6.3.1 Mobile with Wireless DR Detector and Standard Column 80..........
6.3.2 Mobile with Wireless DR Detector and Telescopic Column 81.........
6.4 Physical Characteristics: Mobile with Portable DR Detector 82...............
APPENDIX A --GUIDELINES FOR PEDIATRIC APPLICATIONS A-1...................
APPENDIX B -- PROTECT YOUR IMAGING SYSTEM FROM CYBERSECURITY
THREATS B-1.....................................................
0188K EN 20201116 iii
DX-D 100 Mobile X-ray Unit
User Manual
iv
0188K EN 20201116
SECTION 1 INTRODUCTION
This manual contains all the information necessary to understand and operate
the DX-D 100 Mobile X-ray Unit. It provides a general description, safety and
regulatory information, operating instructions and specifications concerning the
system.
This manual is not intended to teach radiology or to make any type of clinical
diagnosis.
This Unit is designed for general radiography. It provides all the advantages of
high frequency waveform Generators including lower patient dose, shorter
exposure times as well as greater accuracy and consistency.
The Generator is controlled by multiple microprocessors which render a higher
exposure consistency, efficiency in operation and an extended tube life. A high
level of self-diagnostics streamlines serviceability, thereby reducing down time.
DX-D 100 Mobile X-ray Unit
User Manual
All functions, displays and controls are logically arranged, easily accessible and
identified to prevent confusion. Technique factors and functions are selected on
the Control Console.
The Unit consists of the following fundamental parts:
X-RAY GENERATION COMPONENTS
Control Console.
Generator, that comprises:
G Power Module, which contains the power and control
components.
G High Voltage Transformer.
G Battery Module, with the batteries and charge / control
components.
X-ray Tube, part of the Tube-Collimator Assembly.
Tubes: E7865X, E7884X.
0188K EN 20201116
1
DX-D 100 Mobile X-ray Unit
User Manual
ASSOCIATED EQUIPMENT AND SUBASSEMBLIES
According to IEC 60601--2--32, the following subassemblies are considered
Associated Equipment and conform to the applicable safety requirements
therein stated.
Unit Motion Assemblies, that comprises:
G Batteries and Charger Module, to power the motors.
G Motor Assembly, motors and wheels.
G Driving Control Assembly, handlebar, motion controls at the
Tube-Collimator Assembly, gauges and related electronic
components.
Rotating Column and Telescopic Arm, holding the Tube-Collimator
Assembly and allowing its positioning.
There are three Column types available:
G Standard Column.
G Standard Short Column (optional).
G Telescopic Column (optional, only for Mobile with Wireless DR
Detector). The Telescopic Column in parking position reduces the
height of the DX-D 100 Mobile X-ray Unit in order to have
complete visibility and safety when driving the system.
Collimator, part of the Tube-Collimator Assembly:
RALCO R221/A DHHS--170E, RALCO R221/A DHHS--170D.
DR Detectors and Grids.
Holders for DR Detectors, Grids, and Accessories.
2
0188K EN 20201116
Illustration 1-1
DX-D 100 Mobile X-ray Unit
DX-D 100 Mobile X-ray Unit
User Manual
(1)
with Standard Column (1) / with Telescopic Column, optional
Configuration for Wireless DR Detector:
(2)
(2)
Configuration for Portable DR Detector, with Standard
Column
0188K EN 20201116
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DX-D 100 Mobile X-ray Unit
User Manual
1.1 GENERAL FEATURES
The main features of this Unit are:
A solid and ergonomic design. Ease of operation; security and precision
Standard electrical outlet operation with single-phase lines at 100 / 110 /
Independent operation without mains connection (Stand-Alone). In
Constant potential high frequency.
Controls at the Handlebar and Tube-Collimator Assembly for motorized
of all positioning movements relative to the patient.
120 / 127 / 220 / 230 / 240 V~. Automatic line voltage compensation.
normal operating conditions, the Battery Charger keeps batteries stable
and fully charged, provided the Unit is connected to the mains ( charging).
movements of the equipment.
Controls for lock release of Rotating Column (Standard or Telescopic)
and Telescopic Arm. Column rotation in relation to its vertical axis
o
(¦317
), telescopic and vertical motion of the Arm.
Tube-Collimator Assembly rotation in relation to its transverse axis
o
) and horizontal axis (120o). Collimator rotation in relation to its
(360
vertical axis (180
o
).
Operation Control through the NX application and the Software C onsole.
X-ray Handswitch for X-ray exposures.
Remote infrared X-ray Handswitch (optional).
Dosimetry (optional).
Manual Collimation.
Heat Unit storage for the X-ray Tube, even after turning ON/OFF the
equipment.
Tube protection circuitry prolongs Tube life and increases system
performance.
Equipped with closed loop control of X-ray Tube current, kVp and
filaments, which minimize potential errors and the need for
readjustments.
4
0188K EN 20201116
1.2 PRODUCT IDENTIFICATION
To provide manufacturer and product information, each major item in the
equipment has identification labels attached. The labels contain the following
information:
Manufacturer.
Product.
Model, serial number and date of manufacture.
Voltage (V), Input Power (kVA), Frequency (Hz) and Output Power (kW).
Inherent Filtration.
Mass.
DX-D 100 Mobile X-ray Unit
User Manual
Certifications and Symbols.
Place and date of manufacture.
0188K EN 20201116
* The Label data can vary, depending on the DX-D 100 Mobile X -ray Unit model
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DX-D 100 Mobile X-ray Unit
User Manual
1.3 INDICATIONS FOR USE
1.3.1 INTENDED USE
This equipment is intended for use by qualified personnel only.
The DX-D 100 Mobile X-ray Unit is an equipment designed for general
radiography in hospitals, clinics, radiology imaging centers and medical
practices to perform processes and provide X-ray radiographic images of the
skeleton, skull, chest, spine, pelvis, lung, abdomen, extremities and other body
parts on the patients.
Images can be obtained with the patient in the sitting, standing or lying position.
Examinations can be performed to any kind of patient group. Patients may be
physically able, disabled, immobilized or in a state of shock.
This DX-D 100 Mobile X-ray Unit contributes to the metrics of imaging
performance ensuring the efficient use of radiation.
The X-Ray image receptors used in this unit are Digital Detectors.
1.3.2 NORMAL U SE
The Normal Use of this equipment is defined as the Intended Use plus the
Maintenance and Service tasks.
1.3.3 CONTRAINDICATIONS
Do not use the equipment for any purposes other than those for which it is
intended. Operation of the equipment for unintended purposes could lead to
fatal or other serious injury.
This equipment is not intended for mammographic applications.
If children are to be examined, they should always be accompanied by an adult.
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0188K EN 20201116
DX-D 100 Mobile X-ray Unit
User Manual
SECTION 2 SAFETY AND REGULATORY INFORMATION
This section describes the safety considerations, general precautions for
patient, operator and equipment in order to perform a safe operation and
service tasks.
Regulatory information and symbols used in the equipment are detailed in this
section to operate it safely.
2.1 GENERAL
FOR CONTINUED SAFE USE OF THIS EQUIPMENT FOLLOW
THE INSTRUCTIONS IN THIS OPERATING MANUAL. BOTH
OPERATOR AND SERVICE PERSONNEL HAVE TO STUDY
THIS MANUAL CAREFULLY, INSTRUCTIONS HEREIN
SHOULD BE THOROUGHLY READ AND UNDERSTOOD
BEFORE ATTEMPTING TO PLACE THE EQUIPMENT IN
OPERATION, ESPECIALLY THE INSTRUCTIONS
CONCERNING SAFETY, REGULATIONS, DOSAGE AND
RADIATION PROTECTION. KEEP THIS OPERATINGMANUAL
WITH THE EQUIPMENT AT ALL TIMES AND PERIODICALLY
REVIEW THE OPERATING AND SAFETY INSTRUCTIONS.
TECHNICAL INSTRUCTIONS FOR SERVICE PERSONNEL
SUCH AS INSTALLATION, CALIBRATION OR MAINTENANCE
ARE DESCRIBED IN THE RESPECTIVE CHAPTERS OF THE
SERVICE MANUAL PROVIDED WITH THIS EQUIPMENT.
PLEASE STUDY THIS MANUAL AND THE MANUALS FOR
EACH SYSTEM COMPONENT TO BE FULLY AWARE OF ALL
THE SAFETY AND OPERATIONAL REQUIREMENTS.
0188K EN 20201116
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DX-D 100 Mobile X-ray Unit
User Manual
OPERATOR AND SERVICE PERSONNEL AUTHORIZED TO
USE, INSTALL, CALIBRATE AND MAINTAIN THIS
EQUIPMENT MUST BE AWARE OF THE DANGER OF
EXCESSIVE EXPOSURE TO X-RAY RADIATION. IT IS
VITALLY IMPORTANT THAT EVERYONE WORKING WITH
X-RAY RADIATION IS PROPERLY TRAINED, INFORMED ON
THE HAZARDS OF RADIATION AND TAKE ADEQUATE
STEPS TO ENSURE PROTECTION AGAINST INJURY.
OPERATOR MUST HAVE SUFFICIENT KNOWLEDGE TO
COMPETENTLY PERFORM THE DIFFERENT DIAGNOSTIC
IMAGING PROCEDURES WITH X-RAY DEVICES. THIS
KNOWLEDGE IS ACQUIRED THROUGH A VARIETY OF
EDUCATIONAL METHODS INCLUDING CLINICAL WORKING
EXPERIENCE, AND AS PART OF MANY COLLEGE AND
UNIVERSITY RADIOLOGIC TECHNOLOGY PROGRAMS IN
ACCORDANCE WITH LOCAL LAWS OR REGULATIONS.
SERVICE PERSONNEL MUST HAVE SUFFICIENT
KNOWLEDGE TO COMPETENTLY PERFORM THE SERVICE
TASKS RELATED TO X-RAY DEVICES AND PARTICULARLY
TO THE EQUIPMENT DESCRIBED IN THIS MANUAL. THIS
KNOWLEDGE IS ACQUIRED THROUGH A VARIETY OF
EDUCATIONAL METHODS FOR TECHNICIANS IN
ACCORDANCE WITH LOCAL LAWS OR REGULATIONS,
INCLUDING SPECIFIC TRAINING ON THIS EQUIPMENT.
X-RAY EQUIPMENT IS DANGEROUS TO BOTH PATIENT AND
OPERATOR UNLESS PROTECTION MEASURES ARE
STRICTLY OBSERVED. IF THE EQUIPMENT IS NOT
ACCURATELY USED, IT MAY CAUSE INJURY.
ALTHOUGH X-RADIATION CAN BE HAZARDOUS, X-RAY
EQUIPMENT DOES NOT POSE ANY DANGER WHEN IT IS
PROPERLY USED.
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0188K EN 20201116
DX-D 100 Mobile X-ray Unit
User Manual
SPECIAL ATTENTION MUST BE GIVEN TO DIAGNOSTIC
X-RAY EQUIPMENT SPECIFIED TO BE USED IN
COMBINATION WITH ACCESSORIES OR OTHER ITEMS. BE
AWARE OF POSSIBLE ADVERSE EFFECT ARISING FROM
THESE MATERIALS LOCATED IN THE X--RAY BEAM (SEE
THE TABLE BELOW FOR THE MAXIMUM EQUIVALENT
ATTENUATION OF MATERIALS POSSIBLY LOCATED IN THE
X-RAY BEAM).
MAXIMUM ATTENUATION EQUIVALENT mm AL
ITEM
21 CFR
Total of all layers composing the front panel of cassette holder 1.2 1.2
Total of all layers composing the front panel of FILM CHANGER 1.2 1.2
Total of all layers, excluding detector itself, composing the front
panel of DIGITAL X-RAY IMAGING DEVICE
Cradle 2.3 2.3
PATIENT SUPPORT, stationary, without articulated joints 1.2 1.2
PATIENT SUPPORT, movable, without articulated joints (including
stationary layers)
PATIENT SUPPORT, with radiolucent panel having one articulated
joint
PATIENT SUPPORT, with radiolucent panel having two or more
articulated joints
PATIENT SUPPORT, cantilevered 2.3 2.3
1.2 1.2
1.7 1.7
1.7 1.7
2.3 2.3
IEC 60601-2-54:2009
and
IEC 60601-2-54:2009+AMD1:2015
Note 1.-- Devices such as RADIATION DETECTORS are not included in the item listed in this table.
Note 2.-- Requirements concerning the ATTENUATION properties of RADIOGRAPHIC CASSETTES and of INTENSIFYING
SCREENS are given in ISO 4090 [3], for ANTI --SCATTER GRIDS in IEC 60627[1].
Note 3.-- ATTENUATION caused by table mattresses and similar accessories is not included in the maximum ATTENUATION
EQUIVALENT for PATIENT SUPPORT.
Note 4.-- Maximum ATTENUATION EQUIVALENT mm Al is only applied to the corresponding item. If several items given in this table
are located in the path of the X-RAY BEAM between the PATIENT and the X-RAY IMAGE RECEPTOR, each corresponding maximum
ATTENUATION EQUIVALENT mm Al is separately applied to each i tem.
0188K EN 20201116
9
DX-D 100 Mobile X-ray Unit
User Manual
2.2 RESPONSIBILITIES
THIS X-RAY UNIT MAY BE DANGEROUS TO PATIENT AND
OPERATOR UNLESS SAFE EXPOSURE FACTORS,
OPERATING INSTRUCTIONS AND MAINTENANCE
SCHEDULES ARE OBSERVED.
THE EQUIPMENT HEREIN DESCRIBED IS SOLD WITH THE
UNDERSTANDING THAT THE MANUFACTURER, ITS
AGENTS, AND REPRESENTATIVES ARE NOT LIABLE FOR
INJURY OR DAMAGE WHICH MAY RESULT FROM
OVEREXPOSURE OF PATIENTS OR PERSONNEL TO X-RAY
RADIATION.
THE MANUFACTURER DOES NOT ACCEPT ANY
RESPONSIBILITY FOR OVEREXPOSURE OF PATIENTS OR
PERSONNEL TO X-RAY RADIATION GENERATED BY THIS
EQUIPMENT WHICH IS A RESULT OF POOR OPERATING
TECHNIQUES OR PROCEDURES.
NO RESPONSIBILITY WILL BE A SSUMED FOR ANY
EQUIPMENT THAT HAS NOT BEEN SERVICED AND
MAINTAINED IN ACCORDANCE WITH THE MANUFACTURER
INSTRUCTIONS, OR WHICH HAS BEEN MODIFIED OR
TAMPERED WITH IN ANY WAY.
IT IS THE RESPONSIBILITY OF THE OPERATOR TO ENSURE
THE SAFETY OF THE PATIENT WHILE THE X-RAY
EQUIPMENT IS IN OPERATION, BY VISUAL OBSERVATION,
PROPER PATIENT POSITIONING AND USE OF THE DEVICES
THAT ARE INTENDED TO PREVENT PATIENT INJURY.
ALWAYS WATCH ALL PARTS OF THE SYSTEM TO VERIFY
THAT THERE IS NEITHER INTERFERENCE NOR
POSSIBILITY OF COLLISION WITH THE PATIENT OR WITH
OTHER EQUIPMENTS.
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0188K EN 20201116
DX-D 100 Mobile X-ray Unit
User Manual
IT IS THE RESPONSIBILITY OF THE PURCHASER
/CUSTOMER TO PROVIDE THE MEANS FOR AUDIO AND
VISUAL COMMUNICATION BETWEEN THE OPERATOR AND
THE PATIENT.
IT IS THE RESPONSIBILITY OF THE OPERATOR TO ENSURE
THAT ALL THE EXPOSURE PARAMETERS ARE CORRECT
BEFORE PERFORMING AN EXAM TO THE PATIENT, BY
VERIFYING THAT THE PARAMETER SELECTION HAS NOT
BEEN MODIFIED UNINTENTIONALLY OR BY THE C ONTACT
OF EXTERNAL ELEMENTS ON THE CONTROL CONSOLE, IN
ORDER TO AVOID THE OVEREXPOSURE OR THE NEED OF
PERFORMING A NEW EXAM TO THE PATIENT.
MAKE SURE THAT THE X-RAY TUBE IS SET IN WORKING
POSITION WITH THE REFERENCE AXIS (X-RAY BEAM)
POINTING TO THE RECEPTION AREA.
2.3 MAXIMUM PERMISSIBLE DOSE (MPD)
Before operation, people qualified and authorized to operate this equipment
should be familiar with the Recommendations of the International Commission
on Radiological Protection, contained in Annals Number 60 of the ICRP, with
applicable National Standards and should have been trained in use of the
equipment.
THE OPERATOR SHALL USE THE LARGEST POSSIBLE
DISTANCE FROM THE FOCAL SPOT TO SKIN IN ORDER TO
KEEP THE ABSORBED DOSE AS LOW AS REASONABLY
ACHIEVABLE.
0188K EN 20201116
11
DX-D 100 Mobile X-ray Unit
User Manual
2.4 RADIATION PROTECTION
Although this equipment is built to the highest safety standards and
incorporates a high degree of protection against X-radiation other than the
useful beam, no practical design of equipment can provide complete protection,
nor can any practical design compel the operator to take adequate precautions
to prevent the possibility of any persons carelessly, unwisely, or unknowingly
exposing themselves or others to X-radiation.
IT IS THE RESPONSIBILITY OF THE OPERATOR TO
RESTRICT THE ACCESS TO THE UNIT IN ACCORDANCE
WITH LOCAL REGULATIONS FOR RADIATION
PROTECTION.
Because exposure to X-ray radiation can be damaging to the health, use great
care to ensure 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 an 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 secondary radiation depends on the energy and
intensity of the primary beam and the atomic number of the object material
struck by the primary beam. Secondary radiation may be of greater intensity
than that of the radiation reaching the receptor. 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. Lead screens 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 r efer to your “Local Radiation
Protection Rules” as provided by your Radiation Protection Advisor.
12
0188K EN 20201116
DX-D 100 Mobile X-ray Unit
User Manual
Observe the following rules for radiation protection of the
personnel in the examination room during X-ray exposures:
- Wear radiation protective clothing.
- Wear a personal dosimeter.
- Use the different recommended protective materials and
devices against radiation.
- While operating or servicing X-ray equipment, always keep
as large a distance as possible from the Focal Spot and X-ray
beam, never shorter than 2 meters, protect body and do not
expose hands, wrists, arms or other parts of the body to the
primary beam.
- Protect the patient against radiation outside the area of
interest by using protection accessories.
- Use the smallest X-ray field collimation. Make sure that the
area of interest will be completely exposed and the X-ray field
does not exceed the area of interest.
- Select a Focal Spot to patient skin distance (SID) as large
as possible to keep the absorbed dose for the patient as low
as reasonably possible.
The radiation dose decreases or increases according to the
Focal Spot to Receptor distance (SID: Source to Image
Distance): the greater the SID distance, the lower the
radiation dose. The radiation dose is inversely proportional
to the distance squared.
- Select as short an examination time as possible. This will
reduce total radiation dose considerably.
- Use Grids whenever possible.
- Place the region of interest as close as possible to the
image receptor. This will reduce exposure to radiation and
optimize the exposure.
0188K EN 20201116
- Be sure that audible and visual communication between
the patient and operator is established throughout the entire
examination.
13
DX-D 100 Mobile X-ray Unit
User Manual
2.5 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 frequently used, but less accurate, method of determining the amount of
exposure is the placement of film at strat egic locations. After a specified period
of time, develop the film to determine the amount of radiation.
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.
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0188K EN 20201116
2.6 SAFETY SYMBOLS
The following safety symbols may appear in the equipment.
Their meaning are described below.
DX-D 100 Mobile X-ray Unit
User Manual
Caution. Consult accompanying documents.
Safety Symbol. Follow instructions for use, especially those
instructions identified with Advisory Symbols to avoid any
risk for the Patient or Operator.
(Only applies to Standard IEC 60601-1:2005 and
IEC 60601-1:2005+AMD1:2012)
Manufacturer.
Date of Manufacture.
Medical Device.
Catalogue Number (Model reference).
Serial Number.
0188K EN 20201116
Model Configuration.
15
DX-D 100 Mobile X-ray Unit
User Manual
IPX0
General Mandatory action.
Type B applied part.
Protection against harmful ingress of water or particulate matter.
IP Classification: Ordinary.
Ionizing radiation.
Non-ionizing electromagnetic radiation.
Radiation of Laser apparatus.
Do not stare into beam.
(Only applicable to equipment with Laser Pointer)
Dangerous voltage.
General warning, caution, risk of danger.
16
Warning: Ionizing radiation.
0188K EN 20201116
Warning: Non-ionizing radiation.
Warning: Laser beam.
Warning: Electricity.
DX-D 100 Mobile X-ray Unit
User Manual
Warning: Do not place fingers between mobile and fixed parts of the
equipment, it may cause serious injuries to patient or operator.
As well, make sure the patient extremities are correctly positioned
into limit areas during operation, movement of parts may cause
serious damages to patient.
Electrostatic sensitive devices.
No pushing.
No sitting.
0188K EN 20201116
No stepping on surface.
Do not handle.
17
DX-D 100 Mobile X-ray Unit
User Manual
Emergency stop.
“Stand-by” power.
(Only applies to IEC 60601-1:2005 and IEC 60601-1:2005+AMD1:2012)
“ON” power.
“OFF” power.
“ON” / “OFF” (push-push).
Each position, “ON” or “OFF”, is a stable position.
Alternating current.
Three-phase alternating current.
Three-phase alternating current with neutral conductor.
18
N
Connection point for the neutral conductor on Permanently Installed
equipment.
0188K EN 20201116
Direct current.
Both direct and alternating current.
Protective Earth (Ground).
DX-D 100 Mobile X-ray Unit
User Manual
Li/Pb/Cd/Hg
Earth (Ground).
This symbol according to the European Directive indicates that the
Waste of Electrical and Electronic Equipment (WEEE) must not be
disposed of as unsorted municipal waste and must be collected
separately. Please contact an authorized representative of the
manufacturer or an authorized waste management company for
information concerning the decommissioning of your equipment.
This separate collection symbol is affixed to a battery or its packing,
to advise that the battery must be recycled or disposed of in
accordance with local or country laws. The letters below the symbol
indicate whether certain elements (Li=Lithium, PB=Lead,
CD=Cadmium, Hg=Mercury) are contained in the battery. All batteries
removed from the equipment must be properly recycled or disposed.
Please contact an authorized representative of the manufacturer or
an authorized waste management company for information
concerning the decommissioning of your equipment.
Pollution Control. (Only applicable to People’s Republic of China (PRC)).
This symbol indicates the product contains hazardous materials in
excess of the limits established by the Chinese Standards. It must not
be disposed of as unsorted municipal waste and must be collected
separately. Please contact an authorized representative of the
manufacturer or an authorized waste management company for
information concerning the decommissioning of your equipment.
0188K EN 20201116
19
DX-D 100 Mobile X-ray Unit
User Manual
2.7 REGULATORY INFORMATION
2.7.1 CERTIFICATIONS
The DX-D 100 Mobile X-ray Unit covered by this Operation Manual is
authorized to be marked with CE MARKING in accordance with the provisions
of the Council Directive 93/42/EEC as amended by 2007/47/EEC concerning
Medical Devices.
Statement of Compliance with IEC 60601-1-3: DX-D 100 Mobile X-ray Unit
with radiation protection in accordance with IEC 60601-1-3:1994, IEC
60601-1-3:2008 and IEC 60601-1-3:2008+AMD1:2013.
Statement of Compliance with IEC 60601-2-54: DX-D 100 Mobile X-ray U nit
for Radiography and/or Radioscopy in accordance with IEC 60601-2-54:2009
and IEC 60601-2-54:2009+AMD1:2015.
Statement of Compliance with 21CFR Subchapter J: This DX-D 100 Mobile
X-ray Unit conforms to DHHS radiation Standards of 21CFR subchapter J as
of the date of manufacture.
2.7.2 ENVIRONMENTAL STATEMENT ON THE LIFE CYCLE OF THE EQUIPMENT OR SYSTEM
This equipment or system contains environmentally dangerous components
and materials (such as PCBs, electronic components, used dielectric oil, lead,
batteries etc.) which, once the life-cycle of the equipment or system comes to
an end, becomes dangerous and need to be considered as harmful waste
according to the international, domestic and local regulations.
The manufacturer recommends to contact its authorized representative or an
authorized waste management company once the life-cycle of the equipment
or system comes to an end to remove this equipment or system.
2.7.3 MODE OF OPERATION
Continuous operation with intermittent loading, in accordance w ith
Standard IEC 60601--1:1988.
20
Continuous operation, in accordance with Standard IEC 60601-1:2005
and IEC60601-1:2005+AMD1:2012.
0188K EN 20201116
2.7.4 PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
Protection against electric shock hazards in accordance with Standards: IEC
60601-1:1988; IEC 60601-1:2005 and IEC 60601-1:2005+AMD1:2012, IEC
60601-2-54:2009 and IEC 60601-2-54:2009+AMD1:2015.
DX-D 100 Mobile X-ray Unit
User Manual
This equipment has been classified as a type-B (
) device, in accordance with
Standard IEC 60601--1 requirements: Class I -- Type B applied parts.
TO AVOID THE RISK OF ELECTRIC SHOCK, THIS
EQUIPMENT MUST ONLY BE CONNECTED TO A SUPPLY
MAINS WITH PROTECTIVE EARTH.
ACCORDING TO MDD/93/42/EEC, AS AMENDED BY
2007/47/EEC, THIS UNIT IS EQUIPPED WITH EMC FILTERS.
THE LACK OF PROPER GROUNDING MAY PRODUCE
ELECTRICAL SHOCK TO THE USER.
2.7.5 PROTECTION AGAINST HARMFUL INGRESS OF WATER OR PARTICULATE MATTER
Protection against harmful ingress of water or particulate matter: Ordinary
(IPx0), in accordance with Standard IEC 60601-1:1988, IEC 60601-1:2005 and
IEC 60601-1:2005+AMD1:2012.
2.7.6 PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE ANAESTHETIC
MIXTURES
Degree of Safety in the presence of Flammable Anesthetics Mixture with air or
with oxygen or with nitrous oxide: Not suitable for use in the presence of
Flammable Anesthetics Mixture with air or with oxygen or with nitrous oxide,in
accordance with Standard IEC 60601-1:1988, IEC 60601-1:2005 and IEC
60601-1:2005+AMD1:2012.
2.7.7 PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE RADIATION
Protection against hazards from unwanted or excessive radiation in
accordance with Standards IEC 60601-1:1988, IEC 60601-1:2005 and IEC
60601-1:2005+AMD1:2012, and IEC 60601-1-3:1994, IEC 60601-1-3:2008
and IEC 60601-1-3:2008+AMD1:2013.
0188K EN 20201116
21
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