Diagnostic X - ray high voltage generator

DHF-155H4

SPECIFICATION

D1E-HX0040-01

© Hitachi, Ltd. 2016. All rights reserved.

Medical Equipment Classification, Name, and Certification
No.
 Category name & code
Equipment and instruments 9 Medical X-ray equipment and X-ray tubes for such
equipment

 Generic Name
X-ray generator,diagnostic, stationary, (JMDN Code: 37604010)

 PAL Classification
Specially designated maintenance-control-required medical devices

 Trade Name
Diagnostic X-ray high-voltage generator DHF-155H4

 Certification No.
223ABBZX00148000

Marketing Approval Holder and Manufacturer

 Marketing Approval Holder and Manufacturer
Marketing approval holder: Hitachi, Ltd.
Address: 2-16-1, Higashi-Ueno, Taito-ku,
Tokyo, 110-0015, Japan
 Contact Information
Hitachi, Ltd.
Medical System Operations Group, Kashiwa.

Telephone: +81(4)7131-4151

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 Contents

Page
Medical Equipment Classification, Name, and Certification No. ........................................................... (2)
Marketing Approval Holder and Manufacturer.......................................................................................... (2)
Contents............................................................................................................................................................... (3)
1. Product Overview............................................................................................................................................... 1
1.1 Overview ......................................................................................................................................................... 1
1.2 Features ............................................................................................................................................................ 1
2. Product Configuration ........................................................................................................................................ 3
2.1 Standard components ....................................................................................................................................... 3
2.2 Optional components ....................................................................................................................................... 3
2.3 Precautions for Combined Use ........................................................................................................................ 4
3. Product Specifications ........................................................................................................................................ 5
3.1 X-ray high voltage generator DHF-155H4 ...................................................................................................... 5
3.1.1 Rating ........................................................................................................................................................ 5
3.1.2 Functions ................................................................................................................................................... 5
3.1.3 Component parts and functions of the control console ........................................................................... 11
3.1.4 Component parts and functions of the touch panel section (general radiography mode) ........................ 12
3.1.5 Safety circuits .......................................................................................................................................... 15
4. Power Supply Facility ...................................................................................................................................... 16
4.1 Power supply ................................................................................................................................................. 16
5. Installation Environment .................................................................................................................................. 17
6. Compliance with Regulations .......................................................................................................................... 18
7. Exterior Dimensions ......................................................................................................................................... 19
7.1 Dimensions of the standard components ....................................................................................................... 19
7.1.1 Control console ....................................................................................................................................... 19
7.1.2 Control unit ...................................................................................................................................... 19
7.2 Dimensions of the optional components ........................................................................................................ 20
7.2.1 Control console stand .............................................................................................................................. 20
7.2.2 Automatic exposure detection section ..................................................................................................... 20
7.2.3 Radiography footswitch .......................................................................................................................... 21

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1. Product Overview
1.1 Overview

This equipment is inverter controlled X-ray high-voltage generator with a maximum output of 50 kW, used
as an X-ray high-voltage generator of general radiography system, general X-ray digital radiography system,
fluoroscopy system, etc.

1.2 Features

(1) This is a diagnostic X-ray high-voltage generator with a maximum output of 50 kW, using an inverter
control system for high-voltage X-ray control.

(2) Because the shortest possible radiography time (1 ms) is achieved, X-ray images can be produced
with little motion blur.

(3) The control console provides superior operability through a large and easy-to-read color LCD display
and a GUI that employs a touch panel (It differs according to the system configuration).

(4) The inverter control system is also used for filament heating in the X-ray tube assembly. The actual
tube current is measured and feedback control is performed, to achieve a tube current with superior
stability and reproducibility.

(5) Frequently used radiography conditions can be saved as separate anatomical programs. This enables
you to recall the conditions easily from the touch panel. This also ensures that operations are
performed without error, because it is no longer necessary to set the radiography conditions each time
a scan is performed. Also, minor adjustments can be made to the radiography conditions (according to
the body thickness) after the program is called.

(6) For acquisition techniques that perform multiple scans, you can register all the individual conditions
in advance as a sequence program. Each time you perform a scan, you can call the conditions one
after another in sequence from the touch panel, and set them automatically. Techniques can also be
registered in a sequence program. Therefore, this program can also be a one-touch program that
allows you to perform X-ray tube selection with a single operation.

(7) It has a variety of Auto Exposure Control (AEC) function. Using Hitachi's own technology, Smart
Exposure Control (SEC), radiography conditions for obtaining optimum X-ray images can be
automatically set in the FPD incorporated R/F system.In the ABR full auto mode used in X-ray TV
system, radiography conditions are automatically set for obtaining the X-ray image of the proper
concentration without the test exposure, from the automatically determined conditions during
fluoroscopy.

(8) By using the automatic exposure function (optional) with an ion chamber, solid state chamber, or
HI-AUTO (photo timer), the time control can be automated to achieve the appropriate X-ray images.
The setting buttons on the control console can be used to operate the automatic exposure function.

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(9) You can use the touch panel to perform operations related to scanning with the image processing unit.
In addition, by using anatomical programs, you can specify body parts and set the radiography mode
for the image processing unit with a single touch. You do not have to move your hand over to the
mouse to operate the image processing unit while performing scans, enabling smooth examination
operations.

(10) Two modes are available for setting radiography conditions: the three-factor mode and the two-factor
mode. You can switch between these two modes from the touch panel.

 Three-factor mode
The following three conditions can be specified: tube voltage, tube current, and radiography time.
 Two-factor mode
The following two conditions can be specified: tube voltage and mAs. When this method is used,
sufficient performance can be obtained from the X-ray tube assembly because the combination of
the optimal tube current and minimum radiography time is selected automatically according to the
value set for mAs.
(11) A microcomputer is used for managing the permissible load and heat unit (HU control) of the X-ray
tube assembly. HU management uses the estimated HU management method to determine whether the
load set at the time when the radiography conditions are set is acceptable. X-ray conditions can be set
to prevent equipment overload.

(12) A fault diagnosis function is included. If an interlock or abnormal condition occurs, an error code
indicating the details is displayed. A history of abnormal conditions is saved and can be viewed during
maintenance, ensuring superior maintainability.

(13) Through an online connection (optional) to a CR device (FCR series, FUJIFILM Co., Ltd, or
REGIUS series, Konica Minolta, Inc.) or an FPD radiography device (DXR-3000F/PC, CXDI series,
Canon Inc, or CALNEO series, FUJIFILM Corporation, or AeroDR series, Konica Minolta, Inc.),
radiography conditions can be set based on data received from the CR device or FPD radiography
device. It is also possible to transmit irradiation results reflecting the actual irradiation time based on
automatic exposure and the changes in radiography conditions made from the control console.

 FCR, CALNEO is a registered trademark of FUJIFILM Corporation.

 REGIUS, AeroDR is a registered trademark of Konica Minolta, Inc.
 CXDI is a registered trademark of Canon Inc.

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2. Product Configuration
2.1 Standard components

X-ray high-voltage generator: DHF-155H4, 1 set

Contents)
Control unit 1 set
High-voltage generator (included in the control unit) (1 set)
Control console 1 setNote-1

Note-1: When using the equipment in combination with general X-ray digital radiography system
or R/F system, there are cases that this control console is not supplied, and the control
console supplied with the system is used instead.

2.2 Optional components

(1) Control console stand:

① The stand for the control console.

(2) Automatic exposure detection section

 HI-AUTO detector : PDS-***
*** varies depending on the radiography stand.
For HI-AUTO, the controller ZP-HA4F is also required. You can use this controller to connect
HI-AUTO detectors of a maximum of 4 channels.
 ION CHAMBER: ZP-ICX**
Maximum of 3 sheets. *** varies depending on the radiography stand.
 Solid state chamber (semiconductor detector): ZP-SSMC***
Maximum of 3 sheets. *** varies depending on the radiography stand.

(3) High-voltage switch

Switch used to connect the second tube. This switch is integrated with the high-voltage generator and
incorporated into the control unit.
(4) Pulse fluoroscopy function (Only during combination with the Radiography/Fluoroscopy system)
Function used to generate pulsed X-rays during fluoroscopy. When used with the wave tail cutoff unit,
this function can further reduce the radiation dosage.
(5) Wave-tail cutoff unit (Only during combination with the Radiography/Fluoroscopy system)
Unit used to remove the wave tail in pulsed fluoroscopy and reduce the exposure dose. This unit is
integrated with the high-voltage generator and incorporated into the control unit. If the high-voltage
switch is also used, however, the wave tail cutoff unit is mounted to the outside of the control unit as an
independent unit
(6) Radiography hand switch
Two-step stroke-type switch used for general radiography. This switch is optional in R/F system, and

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 standard component in general radiography system.
(7) Radiographic foot switch
Switch used to perform a scan by foot in the radiography room. A double type and two-step type are
available.
(8) Simultaneous exposure prevention function
Function used to interlock multiple devices to prevent simultaneous X-ray exposure when other X-ray
equipment is installed in the same room.
(9) CR and RIS connection function
Function used to input/output radiography conditions from/to a CR device, FPD device, or RIS
terminal through the RS-232C interface.
(10) Dose area product meter connection function
Function used to establish online connection with the dosimeter (which must always be available with
the X-ray equipment) so as to control the patient's exposure to X-rays. When the dosimeter is connected,
this function allows the measured value to be automatically read and reset, so that the dose area product
can be displayed with the irradiation result.
(11) Door interlock function
Interlock function used to prevent X-ray emission when the X-ray room door is open.
(12) Remote maintenance function
By connecting to the Sentinel Agent PC, remote service can be provided using the Internet.

2.3 Precautions for Combined Use

If you want to use the equipment by electrically or mechanically combining it with equipment manufactured
by companies other than Hitachi, Ltd., be sure to contact Hitachi, Ltd. or an authorized representative for
assistance.

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3. Product Specifications
3.1 X-ray high voltage generator DHF-155H4

3.1.1 Rating

(1) X-ray high voltage generator: Inverter type X-ray high-voltage generator
(2) Nominal maximum power: 50kW Note-2
(3) Radiography
150kV 320mA
100kV 500mA
80kV 630mA
63kV 800mA
(4) Fluoroscopy
125kV 8mA Note-3
(5) Power supply input 80 kVA (During X-ray emission)
0.2 kVA (During standby)

Note-2: Nominal maximum power is the product of maximum tube current and tube voltage at a
tube voltage of 100 kV for 0.1 seconds
Note-3: Tube current exceeding 4mA might be restricted by the accumulated heat.

3.1.2 Functions

3.1.2.1 Technique selection

A maximum of eight techniques can be selected from the following:

General radiography, standing posture radiography, recumbent posture radiography, DR radiography,
Fluoroscopy

3.1.2.2 Number of controllable X-ray tube assemblies

A maximum of two X-ray tube assemblies can be controlled.

If the high-voltage switch (optional) is incorporated, a maximum of two X-ray tube assemblies can be
controlled.

3.1.2.3 Radiography

(1) Tube voltage

40 to 150kV, in 1kV steps
The radiography tube voltage change button can be used to specify the settings.
In ABR/SEC auto mode, the optimal radiography tube voltage is automatically set with a value
calculated by the CPU from the fluoroscopy conditions specified with the automatic brightness
adjustment function.

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(2) Tube current
Either of the following two types can be selected at the time of installation:
20 steps of 10, 12, 16, 20, 25, 32, 40, 50, 63, 80,
100, 125, 160, 200, 250, 320, 400, 500, 630, 800 mA
or
39 steps of 10, 11, 12, 14, 16, 18, 20, 22, 25, 28,
32, 36, 40, 45, 50, 56, 63, 71, 80, 90,
100, 110, 125, 140, 160, 180, 200, 220, 250, 280,
320, 360, 400, 450, 500, 560, 630, 710, 800 mA
The radiography tube current change button can be used to set the tube current.
Radiography cannot be performed at less than 0.5 mAs or higher than 800 mAs.
In ABR/SEC full auto, mAs auto or kV/mA Auto mode, the tube current is set automatically
according to the status of the patient and permissible load for the X-ray tube assembly.

(3) Radiographic timer

When timer mode is selected, the following 79 steps can be selected:
1.0, 1.1, 1.2, 1.4, 1.6, 1.8, 2.0, 2.2, 2.5, 2.8,
3.2, 3.6, 4.0, 4.5, 5.0, 5.6, 6.3, 7.1, 8.0, 9.0,
10, 11, 12, 14, 16, 18, 20, 22, 25, 28,
32, 36, 40, 45, 50, 56, 63, 71, 80, 90,
100, 110, 125, 140, 160, 180, 200, 220, 250, 280,
320, 360, 400, 450, 500, 560, 630, 710, 800, 900 ms
1.0, 1.1, 1.25, 1.4, 1.6, 1.8, 2.0, 2.2, 2.5, 2.8,
3.2, 3.6, 4.0, 4.5, 5.0, 5.6, 6.3, 7.1, 8.0s
The radiography timer change button can be used to set the radiography timer.
Radiography cannot be performed at less than 0.5 mAs or higher than 800 mAs.
In ABR/SEC full auto mode, the timer value is automatically set so that the backup mAs preset
according to the radiography region or acquisition technique can be obtained. In time auto mode, the
backup timer value is automatically set.
(4) Product of radiography tube current and time
When mAs mode is selected, the following 65 steps can be selected:
0.50, 0.56, 0.63, 0.71, 0.80, 0.90,
1.0, 1.1, 1.2, 1.4, 1.6, 1.8, 2.0, 2.2, 2.5, 2.8,
3.2, 3.6, 4.0, 4.5, 5.0, 5.6, 6.3, 7.1, 8.0, 9.0,
10, 11, 12, 14, 16, 18, 20, 22, 25, 28,
32, 36, 40, 45, 50, 56, 63, 71, 80, 90,
100, 110, 125, 140, 160, 180, 200, 220, 250, 280,
320, 360, 400, 450, 500, 560, 630, 710, 800
The mAs change button can be used to specify the settings.

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 In ABR/SEC full auto or kV/mA Auto mode, the backup mAs, which has been set in advance
according to the radiography region or acquisition technique, is automatically set.

(5) Focal spot selection

You can use the focal spot selection button to select any focal spot you want, or have the focal spot
selected automatically (with priority given to the small focal spot) by the equipment based on the
radiography conditions and the permissible load of the X-ray tube assembly.
(6) Actual irradiation time/actual irradiation mAs display
The actual irradiation time or actual irradiation mAs is displayed after radiography operation ends.
Which value is displayed depends on whether the two-factor mode or three-factor mode has been
selected. Note that both values are displayed when the ABR/SEC full-auto, the Time auto, or the
automatic exposure function is used.
In addition, the display field blinks to warn the user if irradiation is discontinued by the backup timer
or backup mAs of the automatic exposure function, or if the actual irradiation time or actual
irradiation mAs exceeds the maximum value (999) that can be displayed.

3.1.2.4 Fluoroscopy (Only during combination with the Radiography/Fluoroscopy system)

(1) Tube voltage

40 to 125kVA,in 1kV steps
You can use the fluoroscopy tube voltage setting button to set the tube voltage. The value might be
restricted by the specified tube current, the X-ray tube assembly, or the patient dose value. In
fluoroscopy auto mode, the value is automatically set according to the status of the patient.
(2) Tube current
0.1 to 8.0 mA in 0.1 mA steps
You can use the fluoroscopy tube current setting button to set the tube current. The value might be
restricted by the specified tube voltage, the X-ray tube assembly, or the patient dose value. Tube
current exceeding 4.0 mA might be restricted by the accumulated heat.
In fluoroscopy auto mode, the value is automatically set according to the status of the patient, the
brightness setting, and the irradiation field size setting.
(3) Focal spot selection
Fixed to the small focal spot (Other focal spots might be selected depending on the type of X-ray
tube assembly.)

(4) Pulse fluoroscopy

Frame rate is 30f/s at the maximum. You can use the frame rate selection button to set the frame rate.
The value might be restricted by the FPD/XTV camera used in combination with the equipment or
image processing.

(5) Fluoroscopy timer

Specified in minutes, from 1 to 5 min.
You can use the fluoroscopy timer change button to set the timer.

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 The value is subtracted by 1 after every one minute of fluoroscopy time. When the value becomes
"0", the fluoroscopy alarm is activated. The fluoroscopy alarm keeps sounding until the fluoroscopy
timer reset button is pressed or the fluoroscopy timer is set again. When the fluoroscopy timer reset
button is pressed, the fluoroscopy timer displays the set value again.
After fluoroscopy continues for 10 minutes, it is automatically interrupted. If this occurs, operate the
fluoroscopy switch again to resume fluoroscopy.
(6) Fluoroscopy total timer
Max. 99 min. (POPULUS series) or 150 min. (VISTA series)
The total time of fluoroscopy is displayed up to 99 (150) min.
Press the fluoroscopy total timer reset button or change the patient ID to reset the time to "0".

3.1.2.5 Automatic condition setting (ABR/SEC)

The automatic condition setting modes shown below can be used by ABR method on R/F system in
combination with I.I., and by SEC method on R/F system in combination with FPD.
In this mode, up to six types of conversion and set data can be selected according to the radiography
region. You can use the density change buttons to change the density to one of seven levels.

(1) Fluoroscopy auto

This mode is used to automatically set the fluoroscopy tube voltage and the tube current so that the
fluoroscopy brightness remains constant during fluoroscopy.
The brightness setting button can be used to change the brightness to one of five levels.

(2) Radiography timer auto (R-Time auto)

In addition to fluoroscopy auto mode, you can use this mode to automatically adjust the radiography
timer during radiography using the automatic exposure mechanism.

(3) Radiography tube voltage/tube current auto (R-kv, mA auto)

You can use this mode to automatically set the radiography tube voltage and tube current based on
the fluoroscopy conditions determined automatically during fluoroscopy.
For the radiography tube voltage, the optimum tube voltage is calculated by the CPU based on the
fluoroscopy conditions. For the radiography tube current, the optimum tube current is set based on
the calculated radiography tube voltage and the permissible load of the X-ray tube with priority
given to the small focal spot, or the predetermined radiography tube current is set.

(4) Radiography tube current/timer auto (R-mAs auto)

You can use this mode to automatically set the radiography tube current and the timer based on the
fluoroscopy conditions determined automatically during fluoroscopy and the radiography tube
voltage.

(5) Full auto

You can use this mode to automatically set all the radiography conditions based on the fluoroscopy
conditions determined automatically during fluoroscopy.

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3.1.2.6 Automatic exposure mechanism (ion chamber, solid state chamber, HI-AUTO)

In general radiography, combination of ion chambers, solid state chambers, or HI-AUTO channels is used
to automatically adjust the radiography timer to obtain an appropriate density. You can use the density
change buttons to change the density to one of seven levels. Note that HI-AUTO cannot be used in
combination with general X-ray digital radiography system.
(1) HI-AUTO
Number of channels that can be connected: 4 channels
Number of fields: 1/channel
Sensitivity changeover: 3
Density changeover: ±3
(2) Ion chamber, solid state chamber
Number of chambers that can be connected: 3
Number of fields: 3/chamber
Sensitivity changeover: 3
Density changeover: ±3

3.1.2.7 Permissible load management

(1) Radiography condition management

The CPU always monitors permissible load data for the selected X-ray tube assembly, focal spot,
and radiography conditions. If the load exceeds the permissible range, the CPU interlocks the
radiography operation. In snapshot auto mode, focal spot during radiography and radiography
conditions are selected automatically according to the permissible load.
(2) HU management of X-ray tube
The actual irradiation mAs is measured to calculate and manage the residual heat capacity in the
anode of connected X-ray tube respectively. If the heat capacity exceeds permissible HU value when
radiography is taken with the load that has been set, the radiography circuit is interlocked.
(3) Management of the surface temperature of focal spot
The surface temperature of the focal spot is calculated and managed based on HU and radiography
conditions. If the temperature exceeds specified value, the radiography circuit is interlocked.
(4) Limits on filament current
When flash is used on each focal spot, a limit value is set on the filament current and managed.

3.1.2.8 Anatomical programs

(1) You can associate a set of data consisting of radiography tube voltage, radiography tube current, and
radiography timer with radiography region and radiography direction and assign it to a program
button. In this way, you can set all of these conditions at once by simply pressing the program button.
In addition to the radiography region and radiography direction, you can also register a comment to a
program button.

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 (2) For general radiography:

If the automatic exposure control devices (ion chambers, solid state chambers, HI-AUTO channels)
are attached, information about automatic exposure control can be registered along with radiography
conditions. In this case, 120 types of program conditions (12 types x 10 pages) can be registered for
each technique. In total, a maximum of 960 types of program conditions (120 types x 8 techniques)
can be registered.

(3) For DR radiography technique used with fluoroscopy:

If the image processing unit is attached, the following information can also be registered:
radiography region, radiography mode, irradiation field, split setting, various modes for automatic
condition setting, SEC data page, density tap, etc. In this case, 96 types of program conditions (12
types x 8 pages) can be registered. In addition, for general radiography techniques, 120 types of
program conditions (12 types x 10 pages) can be registered for up to 7 techniques. Thus, in total, a
maximum of 840 types of program conditions (120 types x 7 techniques) can be registered.

(4) The edit function provided by the touch panel allows the user to easily register and change program
conditions.

3.1.2.9 Sequence programs

You can register a maximum of 12 stages, each consisting of a set of conditions specifying an anatomical
program plus a technique, to a program button. By selecting this button, you will be automatically directed to
the next stage, with the conditions programmed for the stage automatically set for you, as you finish with the
current stage.
In addition, this program can be used as a stopwatch by registering the wait time for each stage. A maximum of
120 conditions x 12 stages can be registered.

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3.1.3 Component parts and functions of the control console

Figure 3-1 Control console

〔1〕 Power indicator

When there is power from the power switch to the X-ray control unit, the indicator lights up.
〔2〕 Power ON switch (main power)
Switch used to power on the entire system
〔3〕 Power OFF switch (main power)
Switch used to power off the entire system.
〔4〕 Radiography X-ray emission switch
Two steps used for normal imaging such as general radiography
〔5〕 Radiography hand switch
Two-step stroke-type switch used for general radiography such as normal imaging
〔6〕 Touch panel section
Control device that integrates the display and control sections

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3.1.4 Component parts and functions of the touch panel section (general radiography mode)

Fig. 3-2 Display example of the touch panel section (general radiography mode)

〔1〕 Irradiation indicator

Indicator that lights up during X-ray irradiation
〔2〕 Normal status indicator
Indicator that lights up when the status of the equipment is normal
〔3〕 EXP.READY indicator
Indicator that lights up if X-rays are to be emitted in the next operation
〔4〕 Selected X-ray tube display
The current X-ray tube assembly number is displayed.
〔5〕 Anode rotation indicator
Indicator that lights up while the anode is rotating.
〔6〕 HU/LOAD display
This displays X-ray tube load conditions.
〔7〕 Selected radiography focal spot display
Indicator that displays the current radiography focal spot
〔8〕 Density indicator
Density of such as radiography images adjusted according to acquiring body parts is indicated
in 7 levels from -3 to +3.

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〔9〕 The displays of actual irradiation mAs/actual irradiation time/dose area
(a) Actual irradiation mAs display
The actual irradiation mAs that is measured during a scan is displayed.
(b) Actual irradiation time display
When automatic exposure control is ON:
The actual irradiation time when X-ray irradiation is discontinued by automatic exposure
control (optional) is displayed.
When automatic exposure control is OFF:
The actual irradiation time of X-ray during a scan is displayed when the radiography
condition is set in mAs.
(c) Dose area display
When dosimeter (optional) is connected:
Displays the dose area product for each scan obtained from the dosimeter (TORECK Co,
Ltd, etc).
When dosimeter is not connected:
Displays the dose area product obtained from the skin surface dose of radiography
calculated by the NDD (numerical dose determination).

Note:
1. The NDD method calculates the radiation dosage of the patient (at the surface) using
the X-ray irradiance conditions (for example, tube voltage, tube current, irradiation time,
distance, and filtration) as parameters.
2. The NDD method was proposed by the Exposure Reduction Committee of the Ibaraki
Association of Radiological Technologists (leader: Takehiko Mori). Hitoshi Sato of the
Ibaraki Prefectural University of Health Sciences derived the coefficient and developed
the software. The Ibaraki Association of Radiological Technologists has distributed this
software free of charge for many years in order to promote the NDD method and has
been committed to reducing radiation dosages due to medical exposure.
3. This software is protected by copyright laws and other laws and treaties regarding
intangible property rights. We received licensing from the Ibaraki Association of
Radiological Technologists (chairman: Yoji Nakazawa) and Hitoshi Sato of the Ibaraki
Prefectural University of Health Sciences to provide this equipment to our customers.
When using this equipment, the modification, alteration, reverse engineering, reverse
compilation, or disassembly of this software, in whole or in part, is prohibited.
4. Calculation accuracy is dependent upon the state of control (setting values and
measurement values) and changes over time (filament and target conditions) in the
X-ray equipment, installation of the equipment, and adjustment conditions, and
therefore differs from the actual measurement values from the dosimeter. Note that the
customer must perform inspections on a regular basis to determine the correction
coefficient.

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〔10〕 Radiography conditions display
The radiography conditions (radiography tube voltage, Radiography tube current, Radiation
time or mAs) are displayed.
〔11〕 Page selection buttons
Buttons used to change pages for the anatomical program selection buttons or sequential
program selection buttons.
〔12〕 Anatomical program selection buttons
Buttons used to select the anatomical program.
〔13〕 Density setting buttons
The value of the button you touch is set as the density.
〔14〕 Technique (operation mode) selection buttons
Buttons used to select the technique (operation mode).
〔15〕 Radiography condition setting buttons
Radiography tube voltage setting buttons
Buttons used to set the radiography tube voltage.
Radiography tube current setting buttons
Buttons used to set the radiography tube current.
〔16〕 Automatic exposure display
Display that indicates the automatic exposure control (optional) setting
〔17〕 [DETAIL] button
Button used to set the detailed radiography conditions.

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3.1.5 Safety circuits

The following safety circuits are provided:

(1) Fluoroscopy overcurrent detection (Only during combination with the Radiography/Fluoroscopy
system)
(2) Radiography overcurrent detection
(3) High voltage side earth detection
(4) X-ray tube filament breakage detection
(5) X-ray tube filament overheat detection
(6) Inverter circuit overcurrent detection
(7) Radiographic timer malfunction detection (backup timer operation)
(8) X-ray tube assembly overheat detection
(9) Management of heat capacity (HU) in the anode of the X-ray tube assembly
(10) Management of permissible load of the X-ray tube assembly
(11) Management of tube current in restricted area due to emission characteristics of the X-ray tube
assembly
(12) Self-diagnosis function (CPU memory, peripheral LSI, etc.)
(13) Error check of communication data
(14) Power supply voltage drop, open phase, imbalanced voltage, overvoltage

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4. Power Supply Facility
4.1 Power supply

Number of phase Single-phase AC Three-phase AC Three-phase AC

Rated standard 200/208/220/230/240V 200/208/220/230/240V 380/400/415/440/480V
voltage
Permissible voltage -10% / +10% -10% / +10% -10% / +10%
range (without load)
Power-supply 50/60Hz 50/60Hz 50/60Hz
frequency
Apparent power 0.04/0.04/0.05/0.05/0.06Ω 0.04/0.04/0.05/0.05/0.06Ω 0.15/0.17/0.18/0.20/0.24Ω
resistance or less or less or less
Circuit Breaker rating 100A 100A 50A
Recommended 50kVA or more 50kVA or more 50kVA or more
distributing
transformer capacity
Grounding Type D grounding Type D grounding Type C grounding
requirements installation installation installation
(grounding resistance of (grounding resistance of (grounding resistance of
100 Ω or less) 100 Ω or less) 10 Ω or less)
Note:
1. Be sure to prepare dedicated power supply system for each X-ray device. When common
power supply is used, the operation of the devices used with the X-ray devices might be
affected, due to such as the power supply voltage fluctuation during radiography.
2. Please specify number of phases and power voltage when ordering.
3. Permissible range of frequency fluctuations is within ± 2Hz.
4. When power is supplied from single-phase three-wire system and three-phase
V-connection, it might affect other equipmentwhich has power supplied from the other
phases(for example, lighting equipment, air conditioner, elevator, etc.).
Be sure to use dedicated power supply for X-ray equipment.

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5. Installation Environment
(1) Environment for use
Ambient temperature : Between +5°C and +35°C
Relative humidity : Between 30 and 85% (no condensation)
Barometric pressure : 700 to 1060 hPa
Altitude : 3,000m or less
(2) Environment for storage
Ambient temperature : Between -10°C and +40°C
Relative humidity : Between 30 and 90% (no condensation, no freezing)
Barometric pressure : 700 to 1060 hPa

(3) Environment for transport

Ambient temperature : Between -20°C and +70°C (when packaging)
Relative humidity : Between 20 and 90% (no condensation, no freezing)
Barometric pressure : 700 to 1060 hPa

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6. Compliance with Regulations
This equipment complies with the following regulations:
・ Notification No.75 on March 22, 2001 of the Ministry of Health, Labour and Welfare (Medical X-ray
Equipment Standard)
・ IEC60601-1:2005+A1:2012
Medical electrical equipment‐Part l : General requirements for basic safety and essential performance
・ IEC60601-1-2:2007
Medical electrical equipment - Part l - 2: General requirements for basic safety and essential performance
- Collateral Standard : Electromagnetic compatibility‐ Requirements and tests
・ IEC 60601 - 1 - 3 : 2008＋A1;2013
Medical electrical equipment - Part l - 3 : General requirements for basic safety and essential performance
- Collateral Standard : Radiation protection in diagnostic X - ray equipment
・ IEC60601 - 2 - 54 : 2009
Medical electrical equipment - Part 2-54 : Particular requirements for the basic safety and essential
performance of X-ray equipment for radiography and radioscopy

Compliance with JIS (If the version differs between IEC and JIS, IECs shown above take priority)
 JIS T0601 - 1 : 2012
 JIS T0601 - 1 - 2 : 2012
 JIS T0601 - 1 - 3 : 2012
 JIS Z4751 - 2 - 54 : 2012

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7. Exterior Dimensions
Permissible dimensional deviation: ±10%
Mass tolerance: ±10%

7.1 Dimensions of the standard components

7.1.1 Control console

Weight: 5kg Units: mm

7.1.2 Control unit

Weight: 215kg (standard components)

245kg (Wave tail cutting switch or High voltage switch built-in)
Units: mm

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7.2 Dimensions of the optional components

7.2.1 Control console stand

Weight: 9 kg
320 280 80 Units: mm

7.2.2 Automatic exposure detection section

Approx. 7

Weight: 0.8 kg
Units: mm

This Figure is shown as examples. The configuration and dimensions

might differ depending on the device which can be combined.

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7.2.3 Radiography footswitch

Double type Two-step type

Weight: 1.2 kg Weight: 1.2 kg

Units: mm Units: mm

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 E

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