Ecoray ULTRA 9020BT User manual

DIAGNOSTIC X-RAY UNIT
User Manual (Veterinary)
ULTRA 9020BT
- ORANGE 9020BT, ULTRA 90BT, ANYPLX 3-BT
Document No. : EUM-BT-01
Issued Date : 26.May, 2016
Revision : 1.2
For better performance and safety, this manual may be changed without any prior notice.
The original version of ULTRA 9020BT is being written in English.

Diagnostic X-ray Unit
USER MANUAL
Table of Contents
Section 1. (General Information)
Complied Standard ...................................................................................................... 4
Contact .......................................................................................................................... 5
Guarantee Condition & Contact ................................................................................. 6
Safety Information ........................................................................................................ 7
Radiation Information ................................................................................................... 9
Warning Information ..................................................................................................... 10
Warning Label Information .......................................................................................... 11
Label Information ......................................................................................................... 12
Intended Use ................................................................................................................ 15
Product Name Designation ......................................................................................... 15
Notes to User .............................................................................................................. 15
Symbols and Terms .................................................................................................... 15
Electromagnetic Compatibility (EMC) Statement ....................................................... 16
Proper Environment ..................................................................................................... 19
Accessories Composition ............................................................................................. 20
Dimension ..................................................................................................................... 21
Name of Each Part ..................................................................................................... 22
Operation Panel ........................................................................................................... 23
Specifications ................................................................................................................ 24
X-Ray Tube Specification ............................................................................................ 25
Section 2. (Operation)
Operation Conditions ................................................................................................... 29
Operation Instruction ................................................................................................... 30
Error Code and Corrective Actions ........................................................................... 34
Exposure Data Table .................................................................................................. 35
Designated Significant Zones of Occupancy ........................................................... 36
Section 3. (Service Manual)
User Mode .................................................................................................................... 38
Calibration Mode .......................................................................................................... 40
Default Mode ................................................................................................................ 41
Diagnostic X-Ray Unit Stand Fixing .......................................................................... 42
Section 4. (Schematics)
Block Diagram .............................................................................................................. 44
Power & Driver Board ................................................................................................. 45
Main Board (CPU) ....................................................................................................... 46
Main Board (EP_IP FB) .............................................................................................. 47

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Section 1.
General Information

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Complied Standard
The diagnostic x-ray unit is manufactured according to the following standard and
associated equipment.
■ EMC
☞ EN 55011:2009 / A1 : 2010
☞ EN 60601-1-2 : 2007 / AC : 2010
☞ EN 61000-3-2 : 2006 / A1 : 2009 / A2 :2009
☞ EN 61000-3-3 : 2013
■ SAFETY
☞ EN 60601-1 : 2006 + A1 : 2013
☞ EN 60601-1-3 : 2008(Second Edition) + A1 : 2013
(Diagnostic X-ray Unit with radiation protection in accordance with EN 60601-1-3:2008)
☞ EN 60601-2-28 : 2010(Second Edition)
(X-ray Tube Assembly- [ULTRA 9020BT HV Tank] EN 60601-2-28:2010)
☞ EN 60601-2-54 : 2009(First Edition)
(X-ray Equipment for Radiography: [ULTRA 9020BT] EN 60601-2-54: 2009)
☞ Risk Management Report (Report Number : GDHF-3PBT-05)

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Contact
Manufacturer
Ecoray Co., Ltd.
- Manufacturer : Ecoray Co., Ltd.
- Address : #714~716, ForHu B/D, 58, Wangsimni-ro, Seongdong-gu, Seoul, Korea.
- TEL : [phone] / FAX : [phone]
- E-Mail : sa[email protected] / [e-mail]
- URL : www.ecoviewmedical.com
EC authorized representative
BCF Technology Ltd.
- Address : Imaging House, Phoenix Crescent Strathclyde Business Park
Bellshill, ML4 3NJ, Scotland, UK
- TEL : [phone]
- FAX : [phone]

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Guarantee Condition & Contact
Manufacturer offers the following guarantee to the purchaser of this equipment. The
guarantee is valid for 24 months (Battery Pack : 12 months) from when the
equipment is handed over to the first retail purchaser. The guarantee covers all
problems caused by faulty manufacture or faulty material. Call the customer
department where purchased when problems arise. Customer responsible for freight
charges for repairs.
nThe guarantee is valid only when the equipment is installed in the proper
environment as specified in the usage guide section. Make sure to use the
equipment as instructed in the usage guide section.
nThe guarantee does not cover the damage and loss caused by outside factors
such as fire, flood, storm, tidal wave, lightening, earthquake, theft, abnormal
conditions of operation, and intentional destruction of the system.
nInsubstantial defects do not qualify refund e.g. prices for the batteries, training
materials, and supplies are not covered.
nWe do not take responsibility for damages or loss which appear after the
guarantee period.
nThe guarantee does not cover additional and indirect damages related with
system operation.
nService may be requested by callings [phone] (or email to
[email protected]) customer service department for R.A numbers. The product
name, serial number, date of purchase and the details of the problem should be
provided.
nDefective equipment should be packed properly in a return box and return to
authorized dealer or manufacturer.
nThis guarantee can replace all other guarantees for detailed parts and product.

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Safety Information
This equipment is designed and manufactured with due consideration given to the
safety of the operator and subject, and also to the reliability of equipment. The
following precaution must be observed for additional safety.
Caution
[ General ]
Ø Only an experienced expert should operate the unit.
Ø Before you operate the unit, please fix the unit at a mobile or any stand.
Ø Attention should be paid not expose the unit to factors such as, slant, vibration
and shock (including when traveling) in where the unit should be.
Ø The equipment has been factory-adjustment for optimum performance. Do not
attempt to adjust any present controls or switches except those specified in
this manual for operation.
Ø If you have experienced any trouble with the equipment, turn off the main
switch immediately, and contact its authorized dealer for the service for
assistance.
Ø Do not use the other connector which it does not provided from manufacturer.
Ø The equipment is designed for the purpose of radiographic diagnostic x-ray use
therefore the unit shall not be used for fluoroscopy.
Ø The equipment is designed for the diagnosis purposes, the equipment shall not
be used for therapy.
Ø Be careful not to drop the unit when moving or installation.
Ø The system should be away from water.
Ø Do not use with wet hands.
Ø Do not use the equipment random.
Ø Review operational environmental condition in the manual before use.

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Caution
[ Battery ]
Ø When you discover strange smell or liquid leakage, turn off the power
immediately and report to authorized dealer or manufacturer.
Ø If any liquids from the battery get into eyes, clean it with pure water
immediately and take a medical service as soon as possible.
Ø If battery does not fully charge after prescribed time, stop the recharging and
report to authorized dealer or manufacturer.
Ø Used battery packs have to keep out from reach of infant or children. Electric
shock may be occurred by residual current.
Ø Don't utilize the used battery packs for other purposes except using at this
equipment. Should be disposal it according to national laws or standards.
Ø If user do not use this equipment for a long time, recharge the battery
periodically for preventing a shortening of battery life.
Ø When you change the battery pack or find an error in battery charging, please
take an inspection through engineer of branch-office which you bought the
equipment. If the user arbitrarily remove(combine) the battery pack from(to) the
equipment, there might be an electrical problem.
[ Adapter ]
Ø The adapter for this equipment is rechargeable. Should not be used for any
purpose except recharging.
Ø The equipment is designed not to operate while it is charging so separate the
adapter before using the equipment.
[ Cleaning ]
Ø To make sure that power is off for diagnostic x-ray unit while cleaning. Use a
non-alcohol based disinfectant only - wipes, or a cloth dampened with liquid.
Diagnostic x-ray unit is not designed to be used to sterilize anything else. Do
not use by any other chemical liquid.

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Radiation Information
This equipment is manufactured with the necessary devices and it protects operator
and patient from the ionized radiation that is radiated form the X-ray source
assembly.
Caution
Ø User and operator must use a protective devices (X-ray protection partition) and
a protective clothing (Lead Apron) as appropriate to the workload involved.
Ø During X-ray exposure, only patient should stay in the region of radiation.
Otherwise, the extra object can make unexpected effect to X-ray image that
may interfere correct diagnosis.
Ø Eliminate all the useless objects from the zones, because they are a further
source of secondary radiation, above all near the source.
Ø The focal to skin distance shall be no shorter than 45 cm.
Ø Operators are requested to use minimum kV and mAs values for experimental
use.
Ø Do not exceed in the size of the radiograms and limit the X-ray field size to
the size of interest only.
Ø User(Doctor or Expert) must know patient’s body condition when radiation
X-ray.
Ø If irradiate X-ray while hold the equipment by one's hand, can cause a radiation
exposure and image vibration. Please use the X-ray-only stand. Refer Page.42
for installation.

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Warning Information
This is the important information for the reader or user. User or reader should pay
attention to this important information. If not, serious damage to people or equipment
can be occurred.
Warning
[ General ]
Ø Do not modify this equipment without authorization of the manufacturer.
Ø This unit has built-in dual laser modules for targeting SID therefore Please keep your
eyes away from the source of laser that may harm your bare eyes.
Ø Do not use the equipment close to a flammable or an aesthetic gas. It has the danger
of explosion.
[ Battery ]
Ø This equipment has a built-in battery pack. So, it must avoid high temperature, direct
ray of light. If temperature of battery rise up, heating, explosion and ignition may be
occurred by internal short.
Ø Don't put the battery pack into fire. Don't heat it. A electrolyte can be leaked if
insulating materials are melted. And this can make also heating, explosion and ignition.
Ø Don't give a strong impact to the battery pack. A protective device of battery can be
destroyed so the battery may be recharged by abnormal current & voltage. Also, an
abnormal reaction(heating, explosion, ignition and etc.) can be happened.
Ø Don't take apart or remodel the battery pack. It causes also abnormal reaction(heating,
explosion, ignition and etc.).
Ø The battery pack has a protective device. Don't use the equipment in the place with
lots of static electricity. The protective device can be damaged and abnormal reaction
stated above can be happened.
[ Adapter ]
Ø Please use the adapter sold by its manufacturer only. Using uncertified adapter can
make heating, explosion and ignition due to overcharging or abnormal current.

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Warning Label Information
Warning of dangerous voltage
This label placed on the top of HV Tank. HV
Tank uses high voltage to generate X-ray so
cut off the power before checking and
repairing the unit.
Warning of Laser
This label placed on the side of collimator.
Please keep your eyes away from the source
of laser that may harm your bare eyes.
Warning of ionized Radiation
This label placed on the top of top case.
The ionized radiation is dangerous for the
operator if the appropriate safety measures
are not strictly observed.

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Label Information
Input Power
This label placed on the under
power inlet. This label is input
power spec.
Identification
This label placed on the bottom
case. This label explained product
information.
Beam Limiting Device
This label placed on the side of
collimator. This label explained
collimator information.
High Voltage Tank
This label placed on the top of
HV tank. This label explained
HV tank information.
Battery Pack
This label placed on the top
of battery pack. This label
explained battery pack
information.
Hand Switch
This label placed on the side
of Hand switch. This label
explained manufacturer and
model name, S/N.

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Identification Label
①②
③
No Explanation
①
Basic Information
Electric Current Direct Current
②
User Manual User must be fully aware of the manual before
using.
Disposal
Disposal of this product must be handled according
to local laws and regulations
③
Caution General caution
CE Mark
Commuaute Europeenne (European Community)

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Package Symbol & Label
Symbol Explanation
Note Up/Down Load in correct direction to prevent the damage of equipment.
Wetting
attention Careful about wetting when the equipment is being loaded.
Fragile Because equipment can be damaged, be careful about shock
when loading.
Handle with
care To avoid the damage, shipping by hand is recommended.
CE Mark
Commuaute Europeenne (European Community)
Label
Product Identification & Serial Number
lTemperature Range
lRelative Humidity Range
lPressure Range
Information about temperature, humidity and pressure when
transporting or storing.

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Intended Use
This x-ray unit for veterinary only is equipment to diagnose the fracture of equine’s
joint especially.
Product Name Designation
l Main product name : ULTRA 9020BT
l Addition product name : ORANGE 9020BT, ULTRA 90BT, ANYPLX 3-BT
Notes to User
To ensure safe operation and long term performance stability, it is essential that you
fully understand the functions, operating and maintenance instruction reading this
manual before operating equipment.
Particular attention must be paid to all warnings, cautions and notes incorporated
herein. In correct operation, or failure of the user to maintain the equipment relieves
the manufacturer or his agent from responsibility for any damage or injury as a
result of the system noncompliance.
The responsibility about use of medical apparatus and management of maintenance
is in a user side.
Symbols and Terms
The following symbols will be used in this manual: their meaning and their
application are described further below.
Caution : Calls attentions to action or conditions that could cause light
injury to the user or damage to the instrument or user's data,
and precautions that can be taken to prevent such
occurrences.
Note : They inform the reader about the relevant facts and conditions ;
they draw the attention to important information but, if they are
not taken into consideration, they do not necessarily cause
damages to people or to the equipment.

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Electromagnetic Compatibility (EMC) Statement
The followings are to provide the information of electromagnetic environment based
on EN 60601-1-2:2007 to the ULTRA 9020BT users.
Guidance and manufacturer’'s declaration – electromagnetic emissions
The ULTRA 9020BT is intended for use in the electromagnetic environment specified below. The
customer or the user of the ULTRA 9020BT should assure that it is used in such an
environment.
Emissions test Compliance Electromagnetic environment – guidance
RF emissions
CISPR 11 Group 1
The ULTRA 9020BT uses RF energy only for its
internal function. Therefore, its RF emissions are very
low and are not likely to cause any interference in
nearby electronic equipment.
RF emissions
CISPR 11 Class A
The ULTRA 9020BT is suitable for use in all
establishments, including domestic establishments and
those directly connected to the public low-voltage
power supply network that supplies buildings used for
domestic purposes.
Harmonic
emissions
IEC 61000-3-2
Class A
Voltage
fluctuations /
flicker emissions
IEC 61000-3-3
Complies

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Guidance and manufacturer’'s declaration – electromagnetic immunity
The ULTRA 9020BT Image Intensifier is intended for use in the electromagnetic environment
specified below. The customer or the user of the ULTRA 9020BT Image Intensifier should assure
that it is used in such an environment.
Immunity test IEC 60601
test level Compliance level Electromagnetic environment – guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative humidity
should be at least 30 %.
Electrical fast
transient/burst
IEC 61000-4-4
±2 kV for power
supply lines
±1 kV for input/output
lines
±2 kV for power
supply lines
±1 kV for
input/output lines
Mains power quality should be that of a
typical commercial or hospital environment.
Surge
IEC 61000-4-5
±1 kV differential
mode
±2 kV common mode
±1 kV differential
mode
±2 kV common
mode
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
IEC 61000-4-11
<5 % UT
(>95 % dip in UT)
for 0,5 cycle
40 % UT
(60 % dip in UT)
for 5 cycles
70 % UT
(30 % dip in UT)
for 25 cycles
<5 % UT
(>95 % dip in UT)
for 5 s
<5 % UT
(>95 % dip in UT)
for 0.5 cycle
40 % UT
(60 % dip in UT)
for 5 cycles
70 % UT
(30 % dip in UT)
for 25 cycles
<5 % UT
(>95 % dip in UT)
for 5 s
Mains power quality should be that of a
typical commercial or hospital environment.
If the user of the ULTRA 9020BT Image
Intensifier requires continued operation
during power mains interruptions, it is
recommended that the ULTRA 9020BT
Image Intensifier be powered from an
uninterruptible power supply or a battery.
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m 3 A/m
If image distortion occurs, it may be
necessary to position the ULTRA 9020BT
Image Intensifier further from sources of
power frequency magnetic fields or to
install magnetic shielding. The power
frequency magnetic field should be
measured in the intended installation
location to assure that it is sufficiently low.
NOTE : UT is the a.c. mains voltage prior to application of the test level.

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Guidance and manufacturer’'s declaration – electromagnetic immunity
The ULTRA 9020BT is intended for use in the electromagnetic environment specified below. The
customer or the user of the ULTRA 9020BT should assure that it is used in such an environment.
Immunity test IEC 60601
test level Compliance level Electromagnetic environment – guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to 80 MHz
3 Vrms
80 kHz to 2.5 MHz
3 Vrms
3 V/m
Portable and mobile RF communications
equipment should be used no closer to any part
of the ULTRA 9020BT, including cables, than
the recommended separation distance calculated
from the equation applicable to the frequency of
the transmitter.
Recommended separation distance
d = 12



d = 1,2



80 MHz to 800 MHz
d = 2,3



800 MHz to 2,5 GHz
where P is the maximum output power rating of
the transmitter in watts (W) according to the
transmitter manufacturer and d is the
recommended separation distance in metres (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey,a
should be less than the compliance level in each
frequency range.b
Interference may occur in the vicinity of
equipment marked with the following symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and
land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted
theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured field strength in the location in which
the ULTRA 9020BT is used exceeds the applicable RF compliance level above, the ULTRA 9020BT
should be observed to verify normal operation. If abnormal performance is observed, additional measures
maybe necessary, such as re-orienting or relocating the ULTRA 9020BT.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

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Proper Environment
Caution : Avoid the following environments for operation or storage ;
l Where the equipment is exposed to water vapor.
l Where the equipment is exposed to direct sunlight.
l Where the equipment is exposed to dust.
l Where the equipment is exposed to high humidity.
l Where there is a ventilation problem.
l Where the equipment is exposed to a salty atmosphere.
l Where the equipment is exposed to chemicals or any gas.
nFor normal operation, you must keep away from the place with a strong
vibration and maintain the following range of temperature and humidity.
lOperation Environment
Temperature range: 10 - 40°C (Charge)
10 - 40°C (Discharge)
Relative humidity range: 30 - 75% RH
Pressure: 700 - 1,060 hPa
Height range: 0 - 2,000 m
lThe most optimal recommended rage of temperature and humidity
Temperature range: 17 - 23°C,
Relative humidity range: 40 - 60% RH
n For storage and transportation condition, you must maintain the following range
of temperature and humidity and atmosphere.
lStorage / Transport Environment
Temperature range: -20 - 45°C (Storage 1 month)
-20 - 35°C (Storage 2 month)
-20 - 20°C (Storage 1 year)
Relative humidity range: 10 - 95% RH
Air pressure range: 500 - 1,060 hPa
* non-condensing, not packaged for outdoor storage.

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Accessories Composition
This diagnostic x-ray unit is essentially built up of the following parts:
Since diagnostic x-ray unit is integrated one body X-ray equipment therefore
following regions are firmly fixed and connected of consist of.
Caution : Use hand switch and battery charge adapter, battery pack
which provided from manufacture only. When problems occur
by using other parts, the manufacture does not bear any
responsibility.
Picture Name Specification
Hand Switch
- Manufacture : OMRON
- Model : C2U (Push button switch)
- 2 Steps (1 Step : "Ready", 2 Step : "Shot")
LED Lamp
- Manufacture : CREE
- Model : XP-L
- Voltage : Max. 3.25 VDC, 10W
Battery Charge Adapter
- Manufacture: Fuyuang
- Model : FY5801000
- Input : 100 – 240V~, 50/60 Hz, 80VA
- Output : 58 VDC, 1 A
Battery Pack
(Lithium-Ion Polymer)
- Manufacture : Ecoray Co., Ltd.
- Voltage : 51.8 VDC
- Charge Voltage : 58 VDC ± 0.05 VDC
- Capacity : 2600 mAh
- Size : W118 X L172.5 X H59.5 mm
User Manual - Size : W150 X H120 mm
Aluminum Carrying Case
Shoulder Strap - Length : 125 mm
Aluminum Carrying Case - Size : W395 X L245 X H220 mm