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Manual de Operacion Rayos X Generador
Manual de Operacion Rayos X Generador
Manual de Operacion Rayos X Generador
Operation Manual
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CONTENTS
1. OVERVIEW ................................................................................................................................... 1
3.1 CAUTIONS.................................................................................................................................... 6
3.2 SAFETY AND MARK INSTRUCTION ................................................................................................ 7
3.3 GRAPHIC SYMBOL INSTRUCTIONS ................................................................................................ 8
III
IV
1. Overview
The high frequency high-voltage x-ray generator for medical diagnosis belongs to type I of medical
instrument equipment, which is widely used in productive establishment for producing high
frequency x-ray machine for medical diagnosis as the supporting of high frequency x-ray machine
core components for medical diagnosis and upgrade the technology of the high frequency x-ray
machine for medical diagnosis. The maximum power output is 50kW, the adjusting range of
radiography tube current is 10mA ~ 630mA, the adjusting range of radiography tube voltage is 40
kV ~ 150 kV, the range of current-time product is 0.5mAs ~ 630mAs, and working frequency ≥ 100
kHz. The product has the following prominent features:
a) Simulation and digital double loop accuracy control method: With high frequency inverter
circuit and microprocessor, simulation make up of the special chip PWM, digital double
loop feedback control method, to achieve high accuracy high voltage output, even if power
fluctuation, still can output stable x-rays;
b) High precision radiography time control: The shortest exposure time is 0.002 seconds, can
make radiography fast at any time and completely free the influence of power phase, and
produce high quality x-ray images easily and reduce patients suffering x-ray radiation at the
same time.
c) High precision tube current control: x-ray tube current is adopted two grades high
frequency converter, sampling tube current of high speed A/D converter through
microprocessor calculation for the real-time control, microprocessor manage the allowing
load of x-ray tube, x-ray tube efficiently capable radiography conditions can be set.
d) Kinds of setting modes for radiography conditions: Choose kV, mA and mAs
respectively for radiography conditions set, the quick anatomy programming radiography
(APR) for human body is simplified for the operation; According to x-ray tube capacity
limit locking three parameters select and make capacity protection;
e) Default self-protection, self-diagnosis: Once appear malfunction, generator chain protection,
alarm device, inquiring fault code, convenient for maintenance treatment;
f) Small size, light weight, reducing installation space.
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2. Product structure, working principle, technical performance and applicable
scope
2.1 Structure and composition of product
2.1.1 Model name
The model make up of four parts: the name code of equipment, nominal output power, function
code and type, such as:
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Figure 1 Diagram of high frequency high-voltage x-ray generator for medical diagnosis
2.2 Working principle of product and technology performance
2.2.1 System chart
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b) Relative humidity: 30% ~ 75%
c) Atmospheric pressure: 70kpa ~ 106kpa
2.2.3.2 Transportation and storage condition:
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Circuit breaker main switch
High voltage generator (including computer console):
X-ray Tube:
Dual Focus: small 0.6mm/ large1.2mm,
Table:
Stationary
Radiographic Enclosed Style Table;
Wall mounted
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5) A period of time without using equipments, when put into using again, must make
inspection for equipment operation before using, and make sure the equipments are
normal, work securely.
6) About electromagnetic compatibility problem: because the equipment produces high
power, high frequency and high pressure in instant, and may produce resonance, surge
peak, electromagnetic interference to power grid and nearby space, etc. And the control
circuit may be affected by external high-power electric electromagnetic interference, so
the power must meet the manual requirements.
c) Power supply requirements
1) Power supply equipment is alternating current power with 60Hz single-phase five wires,
main circuit design for 220V voltage, range of power voltage fluctuation within ±22V.
2) Don't allow small and middle size of capacity power generating equipment to supply
power, also not allow other instantaneous high power loading equipment to install at the
same place and make power supply.
3.2 Safety and mark instruction
3.2.1 All electrical connections in the machine belong to permanent connections, and all
metal shells has made protective grounding, grounding resistance is not more than 0.2 Ω.
3.2.2 Shocking protection type: make up of basic insulation and protective grounding
structure, namely type I equipment.
3.2.3 Mark instruction
If ignore this logo to use equipment, may cause death or serious injury,
may cause the parts of high frequency high-voltage generator or whole
equipment damage.
If ignore this logo to use equipment, may cause serious personal injury or
equipment parts or whole equipment damage and data loss.
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Although not warning mark, provide correct use and operation method,
avoid operation mistake and false action.
Functional grounding
Protection grounding terminal
terminal
Type B equipment
The insulation oil has toxic substances in high pressure oil tank, if keep
improperly, cause pollution for environment easily, the disposal of waste
oil must be in strict accordance with the legal regulations of local
environmental protection department.
May cause harm for patients, operators and environment if violate user
operation file and installation supervision. The manufacturer shall not be
responsible for the effect of violating user operation file and installation
guide.
4.1.1.1.2 After equipment arriving installation place, first uncover packing cover plate of high
frequency high-voltage generator, take out the packing list, count boxes one by one, if discovery
any problem should put forward to supply unit in time, because high frequency high-voltage x-ray
generator is more accurate medical electrical equipment, carry should put softly. To requirements of
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installation personnel, because relative particularity and complexity of x-ray equipment, equipment
installation must be obtained certified personnel by the company who can finish installation.
4.1.1.1.3 Selection of installation place, room size, covering area and structure should consider fully
to the convenience of medical work. At the same time, x-ray protective requirements must comply
with the provisions of health epidemic prevention department. Machine room area is not less than
5.5m x 4.5m, room width≥4.5m, the room door width should be not less than 1.5m, height ≥2.0m,
and ground must be smooth, should keep dry and ventilated indoor. X-ray attenuation of the wall in
front of x-ray window and floor surface or floor ≥2mmPb, other parts attenuation ≥1-1.5mmPb.
Notice: Thickness of other building materials meets equivalent 1mmPb (2.4 g/cm3 solid
concrete density should be 210mm; 1.6g/cm3 solid brick density should be 290mm).
4.1.1.1.4 Equipment layout should be appropriate in machine room, but must comply with machine
itself related requirements of position and size, and make full consideration to medical diagnosis
operation and equipment function works normally, more attention to x-ray protection, should set up
effective measures between operating console and x-ray source (x-ray tube components). Now,
offer figure 3 for user reference. So ensure to meet installation requirements of basic flatness and
immobility when users implement local civil engineering for machine room before installation.
4.1.1.1.5 The requirements of power, power inner resistance: Although the machine isn't equip with
special power transformer, still has strict requirements for the power (show in 2.2.3.3); In
installation site, the special power switch of machine should set up in one meter away wall from
operating console, wires length and sectional area of power switch to outside power transformer are
the important factors which relate to inner resistance, so, should choose big enough cross-sectional
area wires according to the input power requirements.
4.1.1.1.6 The machine room layout should be reasonable, and shall not pile up sundries what not
relate to diagnosis, and keep ventilation well. Machine room outside should mark ionizing radiation,
and put a huge working red light.4.1.1.1.7 Protective requirements of grounding devices, shall
ensure grounding device and terminal safe and reliable, and the cross-sectional area of copper wire
≥6mm2.
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Figure 3 Installation diagram (for reference)
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4.1.2 Part installation of high frequency high voltage generator
High frequency high-voltage generator appearance schematic diagram 4
Equip anode cable and cathode cable according to the space layout (cable length). High frequency
high-voltage generator installation includes:
a) Comply with instruction of cable manufacturer, to install each terminal plug accessory;
b) Ensure x-ray tube high-voltage port clean, the entire surface of high-voltage plug which connect
to x-ray the tube including metal to wipe dehydration vaseline; Take high-voltage cables to connect
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to corresponding x-ray tube input port carefully, ensure all the interface connections are correct,
tighten the cable nuts.
c)Wipe dehydration vaseline to the high voltage cables plug which will connect high-voltage
generator to high-pressure socket, the connected x-ray tube and high-voltage cables connect to the
corresponding high-voltage generator socket, ensure all the joints connect correctly, tighten the
cable nuts. (Refer to following picture 5)
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Figure 8 Rotating anode unit and rotating anode motor connection diagram
4.1.2.4 Generator and console connection
A) Plug accessory communication cable to generator communication port, twist plug screws well.
Lay communication cable well. Shown in figure 9.
B) Insert the other end of communication cable into control unit terminal of console keyboard
display unit, twist plug screws well and finish communication cable connection.
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Figure 9 Communication cable and generator connection diagram
4.1.2.5 Other signal cable connection of generator
A) Power management unit circuit to external connection (terminals X6 function show figure 7)
Provide power for radiography bed and diagnosis bed and emergency stop control terminal X6 in
generator, show in figure13. Among, foot 1, 2 are providing power for external radiography bed etc.,
and 220V alternating current power output. Terminal foot 3, 4 are emergency stop control pin, it is
normal working condition when pin 3, 4 are short circuit, cut off power when open circuit.
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Figure 13 The figure of power management unit with external power terminals
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Figure 12 Power net connection
Danger: Generator and power cables still keep connecting, unless close
the circuit breakers which installed in electric cabinet, otherwise, the
power is in connecting condition.
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Make comprehensive inspection for each electric part, whether have any damage, loose, or wire
connection loose, and the grounding connecting condition whether is favorable.
4.2.1.2 Connect each component according to above mentions.
4.2.1.2.1 Connect each component according to above mentions.
a) Connect the knife switch on the wall to generator power wire and grounding wire
provisionally.
b) Connect stator coil terminal 1, 2, 0, temperature protection contact and grounding wire of
x-ray tube components.
4.2.1.2.2 Connect power, turn on equipment (should test as follows).
4.2.1.2.3 Start up normally, choose 16 ~ 630mA shifts in turn, watch all the shifts value whether is
normal one by one.
4.2.1.2.4 Starting up normally, press each mA shift separately, according to the equipment highest
using condition, tests the protective circuit capacity interlocking limit whether is normal. When
selective condition is more than rated using condition, the displayed value on console whether is
limited.
4.2.1.2.5 Check the key of selecting exposure time (mAs), each shift limit whether is normal.
4.2.1.3 Test whole combination equipment (with tube)
4.2.1.3.1 Connect wires
a) The connection between console and high-voltage generator.
b) The connection between high-voltage generator and x-ray tube, high-voltage cable,
rotating anode wire.
c) Each part of grounding wire (notice: Offered grounding wire is yellow/green wire).
4.2.1.3.2 According to the described requirements above, use dehydrated vaseline as filler between
high-voltage plug and high-voltage socket, insert high-voltage cable between high-voltage
generator component and x-ray tube component.
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4.2.1.3.3 Connect power and start up, observe lighting situation of x-ray tube filament, choose
16mA ~ 630mA phase in turn, large focus and small focus should light respectively base on the
corresponding choice of focus filament, avoid large focus and small focus light at same time, or not
light phenomenon.
4.2.1.3.4 Set equipment in a common radiography state, mA chooses 50mA, current-time product
selects 16mAs, observe filament heat situation and anode rotating situation, press the first shift of
hand switch will increase the filament brightness, anode rotation stator coil electrify and rotate.
4.2.1.3.5 Check emergency stop button whether can cut off generator and console power.
4.2.1.3.6 Set equipment in a common radiography state, anode starts rotation after pressing hand
switch first shift, make radiography work after pressing hand switch second shift.
4.2.2 Tube voltage and tube current calibration
After confirming no-loading test is normal, then make loading test.
This equipment has adjusted value kV exactly before it leaves factory, don't need to adjust again
generally, if necessary, can be operated only by the technical personnel who got formal
training, has operation qualification.
4.2.3 Default parameters when start up
The default parameters on system are the last time parameters which display on console panel when
turn off generator.
4.2.4 When finish debugging, use testing card or water bag to test objects for radiography, to
determine equipment is normal or not.
4.3 Console operation
All controls and displays of high frequency X-ray generator are on the console, using liquid crystal
display touch screen for console buttons, voice prompt. The console panel show in figure 7.
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Figure 7 Schematic diagram of console operation panel
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4.3.1 Emergency stop switch
When control panel displays confusion, parameters are beyond the normal range, or
other unpredictable anomalies such as emergencies, or on/off button is no response,
can press the emergency stop switch, and cut off the generator power supply.
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Notice: Before starting, please make sure the emergency stop switch on console in
loosen condition, or the generator can't power on. If meet emergency situation can
press down emergency stop switch to cut off power supply. The air switch must
switch off after turn off the machine, or completely cut off power supply.
When generator goes into the normal working state (show in figure 7), console displays the present
radiography condition and state. Need to change the condition, click plus and minus key under the
corresponding display window.
Click plus kV or minus kV key, can make kV value to 1 kV step quantity change, press the key
don't loosen that can change the kV value quickly. The kV value range: 40-150 kV.
Click mA plus key or mA minus key, can make mA value increase or decrease, each step has been
pre-existing in generator. Press the key don't loosen that can change mA value quickly.
16, 20, 25, 32, 40, 50, 63, 80, 100, 125, 160
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Notice: Maximum current of small focus is 80 mA, minimum current of
big focus is 100 mA, the plus and minus current to a certain value will
switch automatically to small focus or large focus.
Click ms/mAs display window selection window, switch respectively to ms or mAs mode in
exposure time (show in figure 10 and figure 11).
When choose ms exposure time control, click the corresponding window ms or mAs plus key, ms
or mAs minus key, ma value is 1 ms step quantity change. Click mAs plus key, can make mAs
value increase, each parameter has been pre-existing in generator, click mAs minus key can reduce
mAs value, each value has been pre-existing in generator, press the key don't loosen can change
mAs quickly.
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Each set mAs parameter as follow:
0.5,1,1.2,1.6,2,2.5,3.2,4,5,6.3,8,10,12,16,20,25,32,40,50,63,80,100,125,160,200,250, 320
MAs maximum value is 630 mAs, X-ray tube capacity limits, when kV value and mA value are
larger, mAs maximum value will get corresponding limit, it depends on the relation between
console panel set parameter and X-ray tube capacity, automatic processing by microprocessor.
In order to convenient for doctor use, set up 48 kinds of radiography parameter storage units in this
equipment, store in different parts of radiography parameter. Click body part selection key into the
radiography condition interface as shown in figure 12. This interface radiography conditions consist
of two switch keys of front and side part, four kinds of body form keys and six kinds of part keys,
combined use of total 12 keys for selection, provide total of 48 kinds of memory exposure
parameters, selections and use, can be used rapidly in use process. All exposure parameters can be
modified by users according to their requirement, the button icon will brighten when chose by
operator. Choose radiography conditions (body parts, body form, front or side part), the stored
parameters of corresponding selection keys will display on the panel window, this parameters to be
exposure conditions, also can be used for storage after fine-tuning. After exiting setting panel
window of radiography condition, the selected parameters will be displayed on the radiography
condition window (show in figure 13).
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Figure 12 Setting interface diagram of body parts radiography conditions
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Figure 13 Setting diagram of radiography condition parameters
4.3.4.1 The front and side switch key for human body
Body part selection, including front part key and side part key select any key
which will brighten.
Click "focus-switch" key, the generator will switch large or small focus, small
focus image is clear, but the load is better than large focus, and will produce a lot of heat load to
anode. Large focus image is not good as small image, but load capacity is bigger. Tube current
value increase to 100 mA will automatically switch to the large focus, less than or equal to 80 will
switch to the small focus automatically.
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The parameters only through the "save" key can be deposited in the storage unit
of system. Click "save" key, after sending the "di" sound from console, parameters are stored.
In order to improve the system security, reduce wrong operation, prevent internal
parameters changing by mistake, when enter any testing state or modify some internal parameters
that need to enter testing state. Only the technical personnel who through formal training, has the
operation qualification can operate.
Radiography exposure can be used hand switch control that is available, also can
use the control button on panel.
If use control button on panel, press the light button directly, generator will make preparation,
exposure. Loosen that button when you terminate exposure.
If use hand switch for control, press the first phase enter preparing state, press the second phase to
make exposure, also can press two phases at the same time, the generator enter preparing state first
and finish exposure immediately.
4.3.9 Cautions
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a) Avoid high power and full load continuous exposure, between two
powerful exposures and full load exposure should have enough rest time
( time interval ≥ 3 minutes).
c) When take radiography should use lead screen as far as possible (user
should prepare by themselves) and observe window and keep contact with
patient, to avoid the stray radiation.
d) When make radiography, the distance from focus to patient (focal skin
distance) should be as large as possible, must be ≥ 35 cm (except dental
radiography), when take radiography with filter, if filter gathering
distance is 100 cm, so the distance from focus to skin should control
between 80 cm - 120 cm that is advisable.
4.4.1 Starting up
Check all electrical components comprehensively, if damage, loosen, connection is loose,
equipment grounding is good condition or not. Ensure the emergency button is upspring condition,
and power on, click "start" key on the console, machine is in standby mode. Before testing, the first
should have a comprehensive and clear understanding of section 4.5 console operation instruction,
so can operate.
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4.4.2 Radiography condition setting
With the corresponding and key, press preset parameters to display KV, mA and mAs
value.
patient, should follow order to press , these two keys icon lights that mean selected "fat"
and "belly", and then check ("front" key).And kV, mA, mAs value display on console is fat
waist front pre-existing radiography condition in the machine, click next. Exit key can exit
radiography condition setting interface and return to normal working state, selected parameter will
be displayed on window at this time, selected radiography condition will be displayed on console
(show in figure 13).
When enter radiography condition settings interface, press kV, mA, ms/mAs , key, so can
be fine-tuning for each radiography condition. Just press the any corresponding key within twelve
pre-existing keys, machine will work with required radiography parameters.
corresponding , key, amend KV, mA, mAs value to new value, after confirming,
Before putting into use officially, or no use for a long time, should be in accordance with the
following methods to test X ray tube adaptability:
a) Ordinary radiography way, choose 50 mA, 5 ms, 70 kV, make 10 times exposure experiment,
each interval is 2 minutes, if abnormal, reduce mA value, repeat the above test;
b) Choose 80 kV, 100 mA, 5 ms, make 10 times the exposure experiment, each interval is 2
minutes, if abnormal, reduce mA value, repeat the above test.
Notice: when leave unused for a long time and use again, must carry out the testing for X-ray
tube.
Warning: When the first exposure finish, should allow 2 minutes interval before next
exposure, to ensure the X-ray tube cool down sufficiently.
b) Move the patient to effective radiography location, use collimator light to locate under X-ray
radiation center;
a) After using equipment, should be turned off in time, press power off button .
b) Pull out the power supply plug after generator turning off, or switch off air switch.
Notice: Before turning off, must check X-ray tube whether is in initial normal position.
5. Operation instruction
5.1 Safety
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Please store this manual and equipment together, and review manual operation procedure and safety
requirement regularly.
5.1.1 Summarization
Please read the direction carefully before using and keeping it on hand for
reference in order to use equipment for a long time and safely.
X-ray machine will harm patient and operating staff if not compliance with
protection requirement.
Although x-ray is harmful to human, it will not bring danger if operate correctly. Please make
sure maintenance and operation staff has accepted formal training and know the danger of
x-ray. Please read the direction carefully and fully know safe and operational requirement.
5.1.2 Responsibility
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Make sure authorized personnel using the equipment knows harm of x-ray
overexposure.
Should clear manufacturer and its agents and distributors when sell the
describing equipment in this operation instruction, are not responsible for the
injury of x-ray overexposure to patient and operating staff.
X-rays pass anything will cause quadratic (dispersed) rays, secondary radiation strength is
determined by power and strength of initial ray, and atomic number of the radiation object.
Quadratic ray strength may be stronger than X-ray which reaches to film. Should take measures to
preventing quadratic ray.
Must take preventive measures to prevent x-ray:
◆ Time prevention
The longer exposure time, the larger absorbed dose gets. So everyone should shorten the time of
irradiation and reduce the time of staying in x-ray area. When make x-ray examination, operating
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staff must adapt dark environment well, minimize time of irradiation, and choose the best
radiography condition to avoid condemned images.
◆ Distance prevention
Irradiation dose is inverse proportion with distance. When people doubles the distance from
radiographic source (focus point), irradiation dose reduce to its 1/4. Therefore, when x-ray machine
is working, everyone should keep far away from radiographic source (except inspected patient),
when patient in inspection, must increase the distance between skin and focus.
◆ Shielding prevention
When use x-ray for diagnosis or therapy, time prevention and distance prevention will get certain
restriction. The more effective measure is using shielding protection. Lead shielding is a kind of
effective method. To minimize radiation, recommend using lead shield, lead rubber glove, lead
rubber apron, lead glass, lead preventive chair, lead preventive vehicle, and using the x-ray
protective wall to reduce radiation. The thickness of lead screen must be not less than 2mm, or
amount to 2mm lead equivalent, and personal preventive equipment (such as apron, glove, etc.)
must be not less than 0.25 mm thick lead or amount to 2mm lead equivalent. To ensure that your
basic prevention requirement, please refer to the "GB113-2002 medical X-ray diagnosis health
protection standard" which your ray prevention agent offers.
Notice: Don't make x-ray exposure directly for hand, wrist, arm, or
any other part of body when operate or maintain x-ray equipment.
1 mSv×age (public)
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