Eickemeyer HIRAY 30 User manual

USER MANUAL
HIRAY 30
X-RAY MACHINE
Item No. 701130 / 701131
TELEPHONE [phone]
www.eickemeyer.com
Item No. 701130 / 701131Item No. 701130 / 701131

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USER MANUAL HIRAY 30 X-RAY MACHINE
T [phone] | F [phone] | [e-mail] | www.eickemeyer.com

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USER MANUAL HIRAY 30 X-RAY MACHINE
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CONTENT
1. Application and Intended Use ................................................................................................ 4
2. Classifi cation ............................................................................................................................ 4
3. General Dispositions................................................................................................................ 5
4. Safety and Conformity Aspects ............................................................................................... 5
5. Electromagnetic Compatibility (EMC) .................................................................................... 6
6. Protection against Ionizing Radiations ................................................................................. 9
7. Technical Characteristics....................................................................................................... 10
Electrical Data ...................................................................................................................................... 10
X-Ray Characteristics.......................................................................................................................... 10
Features and Mechanical Drawings.............................................................................................. 11
System..................................................................................................................................................... 11
Monoblock ............................................................................................................................................. 12
Collimator............................................................................................................................................... 12
Grid........................................................................................................................................................... 13
Tray ........................................................................................................................................................... 13
Power Supply Input............................................................................................................................. 14
Thermomagnetic Switch................................................................................................................... 14
Turning On and Off ............................................................................................................................. 14
Symbols in Use..................................................................................................................................... 14
Environmental Data............................................................................................................................ 14
Exposure Pause ................................................................................................................................... 15
X-Ray Tube Seasoning Procedure .................................................................................................. 16
8. Accessories.............................................................................................................................. 16
9. Control Console – Touchscreen Display............................................................................... 17
Manual......................................................................................................................................................17
Anatomic................................................................................................................................................. 18
Personal .................................................................................................................................................. 19
Exposure................................................................................................................................................. 19
Confi gure ................................................................................................................................................ 20
10. Messages and Errors .............................................................................................................21
Cleaning.................................................................................................................................................. 21

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1. APPLICATION AND INTENDED USE
The unit is made of:
• A fi xed height column that includes a monoblock, a collimator, and a control console (display touchscreen).
• A 4-way fl oating patient table that includes the bucky tray, the grid holder and the inverter.
The system is supplied with a rotating anode monoblock (300 mA – 100 kV @ 100 ms).
Its use is suitable for a wide range of clinical applications and it’s intended only for qualifi ed, competent, trained staff fully
aware of the risks associated with the ionizing radiations.
The system does not belong to the devices requiring service continuity.
The parts of the product touching the patient are passive elements (table top, straps, etc.); it is possible for the patient to
accidentally get in touch with some of its active parts (power supply and foot switch). It is not invasive and the system must
be used by the operator through the control console due to its correct use.
The unit is intended to be used for performing X-Ray examinations in the fi eld of:
• Traumatology
• Simple interventional radiology
• Respiratory system
• Skeletal apparatus
• Emergency room
Warning!
This X-Ray unit should not be used in places where there’s risk of explosion.
2. CLASSIFICATION
Protection against electrical hazards: Class I (IEC 60601-1)
Protection against direct and indirect contacts: Type B equipment with B-type applied parts
Protection against water penetration: common protection (IPX0)
Mode of operation: continuous operation with intermittent load
Conformity:
HiRay 30 complies with Directive 93 / 42 / EEC classifi ed as IIb and the national and international regulations for devices
emitting ionizing radiation.
Further information can be requested directly at EICKEMEYER®.
Copyright
The software contained in the system belongs to the manufacturer, the user only acquires the right to use the software
together with the equipment itself; this right is not exclusive and is not transferable. It’s also necessary to obtain written
permission from the manufacturer before making any change to the use of the equipment with functions different than those
specifi ed.

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3. GENERAL DISPOSITIONS
The manufacturer produces technologically advanced X-Ray systems in terms of safety and environmental protection. If the
equipment is used properly, there is no risk to people or the environment.
In order to meet the current safety and environmental standards, the materials used can be harmful, such as oil contained in
the monoblock, lead, electronic boards and components. Consequently, if necessary, they must be disposed in accordance with
applicable regional and/ or national regulations.
We underline that it is not possible to dispose of the unit together with industrial and domestic waste but it should be treated
as special waste (EICKEMEYER® is available to provide additional information).
4. SAFETY AND CONFORMITY ASPECTS
The purpose of this manual is to make the use of the system easy and secure. All information contained depicts the current
state of knowledge.
EICKEMEYER® may at any time modify and improve this information when available and update the device following
technological advances.
Warning!
• This X-Ray unit should only be used in accordance with the safety instructions contained in this manual and
should not be used for purposes different than those intended.
• The X-Ray system should only be used by trained personnel in the fi eld of radiation protection and of X-Ray
equipment use.
• The system should not be used in any electrical, mechanical or radiological fault. It must not be used in case of
malfunctioning of signaling or alarm devices.
• If you would like to use the system in combination with other devices, components, or modules that are
uncertain for compatibility use, always make sure that there is no danger to the operator or patient. If you have
any doubt, please consult EICKEMEYER®.
• EICKEMEYER® is responsible for the safety of its products only if their maintenance, repair or modifi cation is
carried out by EICKEMEYER® itself or by staff offi cially authorized by EICKEMEYER®.
• As for any technical equipment, this X-Ray system must be used appropriately and periodical checks and
maintenance must be carried out.
• Circuits and safety devices must in no way be moved, modifi ed or omitted.
EICKEMEYER® does not take any responsibility for malfunctions, damage or hazards arising from an improper use of the
system or from any failure to comply with the maintenance rules.
• The system can only be used in environments complying with current safety standards.
• The system cannot be used in areas where there is risk of explosion.
• Cleaning and disinfecting products, including those used for the patients, can create explosive gas mixtures.
Therefore, use only those products that comply with the current safety regulations.

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5. ELECTROMAGNETIC COMPATIBILITY (EMC)
According to its intended use, this electronic system is in compliance with Directive EMC 89 / 336, which defi nes the maximum
emission levels allowed for electronic equipment and the immunity required against electromagnetic fi elds.
However, it is not possible to exclude with absolute certainty the possibility that radio signals from transmitters (such as
mobile phones or similar mobile radio systems that are compliant to EMC standards) can affect the correct functioning of the
electro-medical equipment if these systems are used in proximity and with relatively high transmitting power.
As a result, the use of such radio equipment should be avoided in the immediate proximity of medical systems electronically
controlled in order to eliminate any risk of interference.
Caution!
All types of transmissions with mobile radio equipment must be avoided.
Mobile phones should be switched off near the equipment.
These rules must be applied when the system is active (i. e. connected to the power supply and ready for operation).
Attached the tables from EMC reports:
Table 1
The HiRay 30 is suitable for use in the specifi ed electromagnetic environment. The purchaser or user of the HiRay 30
should assure that it is used in an electromagnetic environment as described below:
Emissions Test Compliance Electromagnetic Environment
RF emissions
CISPR 11
Group 1 This HiRay 30 uses RF energy only for
its internal function. Therefore, the RF
emission is very low and not likely to
cause any interference in nearby
electronic equipment.
RF emissions
CISPR 11
Class A This HiRay 30 is suitable for use in all
establishments other than domestic
and those directly connected to the low
voltage power supply network which
supplies buildings used for domestic
purposes.
Harmonic emissions
EN 61000-3-2
Not applicable
Voltage fl uctuations / fl icker emissions
EN 61000-3-3
Not applicable

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Table 2
The HiRay 30 is suitable for use in the specifi ed electromagnetic environment. The purchaser or user of the HiRay 30
should assure that it is used in an electromagnetic environment as described below:
Immunity Test EN 60601-1-2
Test Level
Compliance Level Electromagnetic Environment
Electrostatic discharge (ESD)
EN 61000-4-2
6 kV contact
8 kV air
EN 60601-1-2
Test level
Floors should be wood,
concrete or ceramic tile. If
fl oors are covered with
synthetic material, the
relative humidity should be
at least 30 %.
Electrical fast
transient / burst
EN 61000-4-4
2 kV for power supply lines
1 kV for input / output lines
>3m
EN 60601-1-2
Test level
Mains power quality should
be that of a typical
commercial or hospital
environment.
Surge
EN 61000-4-5
1 kV differential mode
2 kV common mode
EN 60601-1-2
Test level
Mains power quality should
be that of a typical
commercial or hospital
environment.
Voltage dips, short
interruptions and voltage
variations on power supply
input lines
EN 61000-4-11
0 % Unfor 0.5 cycles
40 % Unfor 5 cycles
70 % Unfor 25 cycles
0 % Unfor 5 s
EN 60601-1-2
Test level
Mains power quality should
be that of a typical
commercial or hospital
environment. If the user of
the HiRay 30 requires
continued operation during
power mains interruptions, it
is recommended that the
HiRay 30 be powered from
an uninterruptible power
supply or a battery.
Power frequency (50 / 60 Hz)
magnetic fi eld
EN 61000-4-8
3 A/ m EN 60601-1-2
Test level
Power frequency magnetic
fi elds should be at levels
characteristic of a typical
location in a typical
commercial or hospital
environment.

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Table 3
non-LIFE SUPPORTING EQUIPMENT
The HiRay 30 is intended for use in the electromagnetic environment specifi ed below.
The customer or the user of the HiRay 30 should assure that it is used in such an environment
Immunity Test EN 60601-1-2
Test Level
Compliance Level Electromagnetic Environment
Portable and mobile RF communications equipment
should be used no closer to any part of the HiRay 30,
including cables, than the recommended separation
distance calculated from the equation applicable to the
frequency of the transmitter.
Recommended separation distance
Radiated RF
EN 61000-4-3
3 V / m
80 MHz to 2.5 GHz
3 V / m d = 1.2 x P 80 MHz to 800MHz
d = 1.2 x P 800 MHz to 2.5GHz
Conducted RF
EN 61000-4-6
3 V
150 kHz to 80 MHz
3 V d = 1.2 x P
Where Pis the maximum output rating of the transmitter
in watts (W) according to the transmitter manufacturer and
d is the recommended separation distance in meters (m).
Field strengths for fi xed RF transmitter, as determined by
an electromagnetic site survey, should be less then the
compliance level in each frequency range.
Interference may occur in the vicinity of equipment marked
with the following symbol:

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Table 4
Recommended Separation Distance for non-LIFE SUPPORTING EQUIPMENT
The HiRay 30 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The
customer or the user of the HiRay 30 can help prevent electromagnetic interference by maintaining a minimum distance
between portable and mobile RF communications equipment (transmitter) and the HiRay 30 as recommended below,
according to the maximum output power of the communications equipment.
Rated Maximum
Output Power of
the Transmitter (W)
Separation Distance according to Frequency of Transmitter (M)
150KHz to 80MHz
d= 1.2 x P
80MHz to 800MHz
d= 1.2 x P
800MHz to 2.5GHz
d= 2.3 x P
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at the maximum output power not listed above, the recommended separation distance d in meters
(m) can be estimated the equation applicable to the frequency of the transmitter, where Pis the maximum output power
rating of the transmitter in watts (W) according to the transmitter manufacturer.
Note:
1. At 80MHz and 800MHz, the separation distance for the higher frequency range applies.
2. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and refl ection
from structures, objects and people.
6. PROTECTION AGAINST IONIZING RADIATIONS
Warning!
Before performing any exposure please make sure that all necessary radiation precautions have been activated.
During the use of X-Rays, personnel in the room must comply with the applicable regulations for radiation protection. For this
purpose, keep in mind the following rules:
• Use radiation protection accessories in addition to the devices already provided in the equipment.
• Use special protective aprons. A radioactive material equivalent to lead 0.35 mm reduces a 50kV radiation of 99.95 % and
a 100kV radiation of 94.5 %.
• Distance is the best protection from radiation; keep the maximum distance possible from the X-Ray source and the patient,
for this purpose use the entire length of the foot switch / hand switch cable.
• Avoid moving or standing directly in the radiation beam.
• Always use the smallest possible exposure range by properly closing the collimator diaphragms since the dispersed
radiation depends on the volume of the irradiated object.
Warning!
Under no circumstances the safety circuits must be changed or deactivated for accidental exposures.

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7. TECHNICAL CHARACTERISTICS
Electrical Data
Description Data
Tension 230 Vac monophase standard
Frequency 50 / 60 Hz
Current consumption 1A
Line resistance ≤ 1Ω
Insulation class Class I con type B applied parts (IEC 60601-1)
Use condition Continuous operation with intermittent load
System not suitable to be used in the presence of fl ammable mixtures with air or nitrous oxide
X-Ray Characteristics
Characteristics Performance
Working technique 2 points technique (kV and mAs)
3 points technique (kV – mA – ms)
Anatomically programmed X-Ray technique (APR) 1,800 possible combinations
Exposure control kV and mA constant throughout the exposure
Small Focus (EN 60336) 0.6 mm
Big Focus (EN 60336) 1.3 mm
Max Exposure Field 43cm x 43cm
Generator power in DC voltage 30kW @ 100kV
Inverter frequency 40kHz
kV range 40 – 125kV in step of 1kV
mA range 80 – 400 mA (automatically associated with kV in 2 points
technique)
mAs range 0.60 – 80 mAs
Time range 0.002 – 1s according to the set mAs
Duty cycle Calculated for an average load of 100 W per tube
Small Focus (0.6) Big Focus (1.3)
Max power 12.5kW @ 100kV 0.1sec 30kW @ 100kV 0.1sec
kV range 40 – 125 Step of 1kV 40 – 125 Step of 1kV
mAs range 22 values
0.6 - 0.8 - 1 - 1.3 - 1.6 - 2 - 2.5 - 3.2 - 4 - 5
- 6.4 - 8 - 10 - 13 - 16 - 20 - 25 - 32 - 40
- 50 - 64 - 80
22 values
0.6 - 0.8 - 1 - 1.3 - 1.6 - 2 - 2.5 - 3.2 - 4 - 5
- 6.4 - 8 - 10 - 13 - 16 - 20 - 25 - 32 - 40
- 50 - 64 - 80
Max current 160mA from 40 to 59kV 400mA from 40 to 59kV
120mA from 60 to 79kV 300mA from 60 to 99kV
80mA from 80 to 125kV 200mA from 100 to 119kV
100mA from 120 to 125kV
Exposure Time from 2ms to 1sec from 2ms to 1sec

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Features and Mechanical Drawings
Description Data
SYSTEM GROUP Weight 200 kg
MONOBLOCK Weight 20 kg
GENERATOR Weight 30 kg
System
630mm
760mm
780mm
2,000mm
1,500mm
300mm
300mm
max. 950mm
100mm
720mm
100mm
Picture 1: System

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Monoblock
The X-Ray unit HiRay 30 is equipped with FCX 30 a 30KW monobloc.
Picture 2: Monoblock
Collimator
The irradiation fi eld is delimited by the collimator Claymount 50250-11, equipped with timed LED illumination.
Picture 3: Collimator

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Grid
An anti-scatter grid is installed if the fi lm system or the indirect digital system (CR) are used.
Picture 4: Grid
Tray
If the fi lm system or indirect digital system are used, there is a tray suitable to hold the image acquisition device.
It is equipped with a cassette fi xing system which is operated by the handle visible on the front bracket (unscrew it to unlock
and screw it to lock), and it allows vertical centering; in order to prevent the total fall out of the tray, there are 2 locking
devices limiting the extraction (press the aforementioned towards the tray in order to remove it completely).
Picture 5: Tray

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Power Supply Input
The system is equipped with a 3-pin IEC connector for the power supply, making it easy to adapt the connection to the
different systems (by simply replacing the power cord).
Thermomagnetic Switch
As fi rst safety system there is thermomagnetic switch located on the back of the system.
Turning On and Off
The system turns on by pressing the start button (hold for at least 3 seconds); to turn off the machine simply press the button
in the touch control command (do not interrupt the line).
Symbols in Use
Please consult the manual before use Big Focus
Warning Small Focus
Ionizing radiation Manufacturer
Ground protection Serial number
WEEE Waste Electrical and Electronic
Equipment Manufacturing date
AC Dangerous voltage
Environmental Data
Description Normal use Storage
Temperature
Humidity 30 % 75 % 10 % 90 %
Atmospheric Pressure 700 hPa 1,060hPa 500 hPa 1,060hPa

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Exposure Pause
In order to avoid the monoblock overheating, it’s necessary to pause between one exposure and the next. This simple procedure
allows the dissipation of the produced heat.
The following chart shows the minimum exposure pause, expressed in seconds, among consecutive exposures:
80 65 73 80 87 95 102 109 116 124 131
64 52 58 64 70 76 81 87 93 99 105 111 116 122
50 41 45 50 55 59 64 68 73 77 82 86 91 95 100 105
40 33 36 40 44 47 51 55 58 62 65 69 73 76 80 84 87 91
32 26 29 32 35 38 41 44 47 49 52 55 58 61 64 67 70 73
25 20 23 25 27 30 32 34 36 39 41 43 45 48 50 52 55 57
20 16 18 20 22 24 25 27 29 31 33 35 36 38 40 42 44 45
16 13 15 16 17 19 20 22 23 25 26 28 29 31 32 33 35 36
13 11 12 13 14 15 17 18 19 20 21 22 24 25 26 27 28 30
10 8 9 10 11 12 13 14 15 15 16 17 18 19 20 21 22 23
8 7 7 8 9 9 10 11 12 12 13 14 15 15 16 17 17 18
6.4 5 6 6 7 8 8 9 9 10 10 11 12 12 13 13 14 15
54555667788991010101111
434445556677788899
3.233334445556666777
2.522333334444555556
222222333333444445
1.611222222233333334
1.311112222222223333
111111111222222222
0.811111111111122222
0.601111111111111111
KV 45 50 55 60 65 70 75 80 85 90 95 100 105 110 115 120 125

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After periods of idle time (more than 2 months) the seasoning procedure of the X-Ray tube is highly recommended,
described as follows:
X-Ray Tube Seasoning Procedure
kV Voltage mA current Exposure sec. Pause sec. Number of
exposure
Total exposure
Warm-up
40 80 0.5 15 /
50 80 0.5 15 /
60 80 0.5 15 /
70 80 0.5 15 / 12
kV load
80 80 0.01 5 3
90 80 0.01 5 3
100 80 0.01 5 3
110 80 0.01 5 3
120 80 0.01 5 3
125 80 0.01 5 3 18
Radiography
85 160 0.1 6 4
95 160 0.1 6 4
105 160 0.1 6 4
115 160 0.1 6 4
125 160 0.1 6 4 20
8. ACCESSORIES
Accessory Characteristics State
Foot switch or hand switch IEC 60601-1, IEC 60601-1-3 e IEC 60601-2-7 Provided
Collimator 24VDC max 24W Provided

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9. CONTROL CONSOLE– TOUCHSCREEN DISPLAY
This X-Ray unit must be operated by
authorized people only, according to the end
user manual and current laws.
v 1.29 Enter
Picture 6: Software, homepage
The system is equipped with a color graphic display and touch screen as the only input device, the interface is simple and
really user-friendly. When the system is turned on, it displays a presentation page, after pressing the “ENTER” button, it will be
possible to use the system with a series of buttons and video indications, where you can select modes and parameters for the
exposure:
Manual
It’s possible to insert manually the parameters Kv, mA and select the focus.
manual
anatomic
personal
save
focus
congure
HiRay 30
wait
5.0 kg
ready
off
X-ray
ready
Focus: 0.6
kV
50
time
40 ms
mA
160
manual
focus
Picture 7: Software, manual selection

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Anatomic
The system provides selection through the anatomical chart, by selecting the animal.
manual
anatomic
personal
save
focus
congure
HiRay 30
wait
5.0 kg
ready
off
X-ray
ready
Focus: 0.6
kV
50
time
40 ms
mA
160
anatomic
Picture 8: Software, anatomic settings
Then clicking on the body area.
manual
anatomic
personal
save
focus
congure
HiRay 30
wait
5.0 kg
ready
off
X-ray
ready
kV
50
time
40 ms
mA
160
Focus: 0.6
focus
anatomic
Picture 9: Software, anatomic settings, body area selection

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Furthermore, it’s also possible to select the anatomic projection of the chosen part.
manual
anatomic
personal
save
focus
congure
HiRay 30
wait
5.0 kg
ready
off
X-ray
ready
Skull LAT. Mandible OBLIQUE
Skull VD Mandible AXIAL
Skull DV
Maxilla OBLIQUE
Maxilla NASAL
kV
50
time
40 ms
mA
160
Focus: 0.6
focus
anatomic
Picture 10: Software, anatomic settings, body part selection
Personal
If the user would like to change the parameters in the anatomical table, the PERSONAL table must be used and then the SAVE
button must be clicked in order to store the changes.
manual
anatomic
personal
save
focus
congure
HiRay 30
wait
5.0 kg
ready
off
X-ray
ready
Focus: 0.6
kV
50
time
40 ms
mA
160
personal
Picture 11: Software, personal settings
Exposure
In order to get the correct exposure, after selecting the appropriate parameters for the exam:
• When the green button “X-Ray ready” is lit, slightly press the double action foot switch.
• After the “ready” button turns green, increase pressure on the double action foot switch and wait till the end of the
exposure signaled by the beeper.
• Release the foot switch once the X-Ray exposure has been completed and wait till the “ready” button turns green again in
order to repeat the procedure.

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Confi gure
The user can choose among several settings:
manual
anatomic
personal
save
focus
congure
HiRay 30
wait
5.0 kg
ready
off
X-ray
ready
SYSTEM CONFIGURATION
LANGUAGE
Italiano DeutschEnglish Español
Polish DanskDutch Franҫais
WORK
Kv / mAs Kv / mA/ Time
MODE
Weight kg Thickness cm
SCREEN
100 DR200 400
Reset
Log OK
personal
focus
Picture 12: Software, confi guration
Language
Language of the interface.
Work
Selection 2 or 3 points technique.
Screen
Sensitivity of the intensifying screen.
Mode
Size of the patient according to its weight or thickness.