5KW User Manual - EN - v1 3 For Human

ULTRA 100HF (5kw Portable X-Ray)
Operational & Service Manual
EcoRay Co., Ltd.
3F, Urbanlight B/D, 630,

Eonju-ro, Gangnam-gu, Seoul, Korea
TEL : +82 70 7510 3403
FAX : +82 70 8630 3420
EUM-Vet-06 (Rev.0)
ULTRA 100HF Operational & Service Manual
Revision
Reason for
Chapter Page Document Rev Date
changes
New Release 0.0 Jan 1, 2015
1
Table of Contents
Chapter i Safety Information
Introduction
Manual Conventions
Regulations and standards
Qualification of personnel
Service and Maintenance
Operation, Installation and Repair
DIAGNOSTIC X-ray SYSTEMS RADIATION Cautions
Radiation and X-Ray General Safety Information
Diagnostic Reference Level
Cautions in Radiation Room
Target treatment group and diseases
Contraindications
Side effect
Identification labels
Symbols Information
Electrical and Mechanical Safety
Procedural Safety
Disposal
User Maintenance/Servicing
Environmental Safety and Operating Environment
Electromagnetic Compatibility (EMC)
Warranty Scope
Manufacturer’s Responsibility
Chapter ii Operational & Service
Chapter 1 Introduction
1.1 Introduction
1.2 Description
1.3 Composition of ULTRA 100HF
1.3.1 Components of ULTRA 100HF
2
1.4 Dimensions
1.4.1 Basic Dimensions
1.5 Specification
1.6 Abbreviations
1.7 Certification Labels
Chapter 2 Operation
2.1 Safety Precaution
2.2 Specifications
2.3 General Description
2.3.1 Safety Distance
2.3.2 Power ON/OFF
2.3.3 Input Power & Grounding
2.4 Operational Panel Description
2.5 Shooting Scope
2.6 Preparation Before Operation
2.6.1 Safety Precaution
2.6.2 Check on Collimator with Laser Pointer
2.6.3 Exposure Control
2.6.4 Mode Selection
2.7 APR Operation
2.8 Shooting Terms
2.9 Radiation Dose Display
2.9.1 DAP Calculation worksheet
Chapter 3 Calibration & Adjustment

3.1 Introduction
3.2 Calibration
3.2.1 Auto kVp
3.2.2 Auto mA
3.2.3 Auto-Gain
3.2.4 Manual kVp
3.3 DR Interface
Chapter 4 Troubleshooting
4.1 Introduction
4.2 Error Code Troubleshooting
Chapter 5 Maintenance
3
5.1 Periodic Maintenance Schedule
5.2 Cleaning External Surface
5.3 Operation Check
5.4 END OF PRODUCT LIFE
Chapter6 Electrical Schematic

6.1 Introduction
6.2 List of Schematics
Chapter7 Illustrated Parts List

7.1 Introduction
7.2 Spare Parts List
4
Safety Information
Introduction
i
The policy of EcoRay Co., Ltd is to provide X-ray equipments that meet high standards of
performance and reliability. We enforce strict quality control techniques to eliminate the
potential for defects and hazards in our products.
The safety guidelines provided in this section of the manual are intended to educate the
operator on all safety issues in order to operate and maintain in a safe manner.
5
Manual Conventions
ULTRA 100HF is a diagnostic system to obtain the information necessary for the diagnosis
of the patient through the anatomical structure of human body obtained by a film or an
image processing (workstation) after process of examination using radiation exposure with
cassette IP, CR or DR (Portable flat panel).
This manual includes the contents regarding service and operation integrated together.
This manual provides the operational guidelines of the ULTRA 100HF to service
technicians, operators and other people related with ULTRA 100HF.
This manual cannot be used for training, repair or licensor of radiation equipment inside of
the hospital. This equipment must be handled by proper radiologists own radiation devices
license.
ULTRA 100HF is a portable X-ray generating device that is designed to be used with
supporting devices or shooting table. This equipment can receive maintenance service of
the equipment since the installation.
This manual uses three types of messages to emphasize information or potential risks to
personnel or equipment. To ensure safety, read all Safety Information provided herein and
observe all.
 WARNING
 CAUTION
 NOTE
Warning
An instruction that draws attention to the risk of injury or death.
Caution
An instruction that draws attention to the risk of damage to the product or
proper use of the product.
Note
Provides additional information such as expanded explanations, hints or
reminders.
Regulations and standards

The equipment comply with the following regulations and standards;
1) EN 60601-1:2006 Medical electrical equipment

Part 1: General requirements for basic safety and essential performance
2) EN 60601-1-2:2007 Medical electrical equipment
Part 1: General requirements Section1.2 Collateral standard: Electromagnetic
compatibility
6
3) EN 60601-1-3 : 2008 General Req. for Radiation protection in diagnostic X-ray

equipment
4) IEC 60601-1-8 Ed. 2.1b Medical electrical equipment - Part 1-8:
General requirements for basic safety and essential performance - Collateral
Standard: General requirements, tests and guidance for alarm systems in
medical
electrical equipment and medical electrical systems.
5) EN 60601-2-28:2010 Medical electrical equipment. Particular requirements for
the basic safety and essential performance of X-ray tube assemblies for
medical
diagnosis.
6) EN 60601-2-54 : 2009 Particular requirements for the basic safety and essential
performance of X-ray equipment for radiography and radioscopy
7) EN 1041 [2008] Information supplied by the manufacturer with medical devices
8) EN ISO 15223-1 [2012] Graphical symbols for use in the labeling of medical
devices
9) IEC 60878 2ed Graphical symbols for electrical equipment in medical practice
10) IEC 60417-1 Graphical symbols for use on equipment –Part 1: Overview and
application
11) ISO 7010:2011, Graphical symbols – Safety colors and safety signs –Safety
signs
used in workplaces and public areas
12) ISO 9001:2008, Quality management systems – Requirements
13) EN ISO 14971:2012, Medical devices – Risk Management.
14) EN ISO 13485:2012, Medical devices - Quality management systems –
Requirements
for regulatory purposes
15) IEC 62348/TR Ed. 1.0 Mapping between the clauses of the third edition of
IEC60601-1 and the 1998 edition as amended
16) IECEE OD-2044-Ed.1.0 Guidance for the evaluation of risk management in
medical
electrical equipment
17) Council Directive 93/42/EEC as amended by Directive 2007/47/EC concerning
medical devices medical electrical equipment
* Please refer the technical data of each components for more detailed information.
Note
Only a qualified, authorized Service Provider should service/repair electrical or
mechanical components.
Qualifications of personnel
Operating personnel
Before using the ULTRA 100HF, it is required that the operating personnel is
thoroughly familiar with the operating instructions, in particular:
 Safety
 Function and Safety Checks
Acceptance tester
7
The equipment should be tested by a qualified person that can perform the test, evaluate
the result for compliance and knowledge of radiation safety to national regulations.
Caution
Federal law restricts this device to sale by or on the order of a physician.
guidance of trained health care professionals.
Service personnel
The equipment shall be serviced only by qualified personnel who:

 are completely familiar with the system
 have read and understood “Instruction for use” and “Installation and Service
Instructions”
 know how to remove power to the unit in case of an emergency
 are trained in the use of equipment and procedures of this type.
Failure to follow the instructions given in this manual could result in serious injury to the
service person, patient and operator.
Note
It is the responsibility of the owner to ensure that the system is operated only by
trained radiologist, service technicians or product specialists.
Note
It is the responsibility of the supplier to ensure that the technicians have the right
training and knowledge to perform service and maintenance.
Service and maintenance
Note
When Service or Maintenance will be performed the technician shall lock the
equipment from all energy sources.
To ensure the safety of the patients, the operator and third parties, the equipment must be
checked according to the Function and Safety Checks instructions to maintain reliability
and serviceability.
If national rules or regulations specify more frequent checks and/or maintenance, such
regulations must be observed.
8
Caution
No modification of this equipment is allowed.
Do not modify this equipment without authorization of the manufacturer.
If this equipment is modified, appropriate inspection and testing must be
conducted to ensure continued safe use of equipment.
Operation, installation and repair

Modifications of, or additions to the product must be made in accordance with the legal
regulations and generally accepted engineering standards.
EcoRay cannot assume responsibility for the safety features and for the reliability and
performance of the equipment, if:
 installation of equipment expansions or modification are not approved by EcoRay.
 installation of equipment expansions or modification are not carried out by
persons authorized by EcoRay.
 components are not replaced by original spare parts in case of a malfunction.
 the electrical installation of the room concerned does not meet the
requirements or the corresponding national regulations.
 the product is not used in accordance with the operating instructions.
DIAGNOSTIC X-ray SYSTEMS RADIATION Cautions

X-RAY and GAMMA-RAYs are dangerous to both operator and other in the
vicinity unless established safe exposure procedures are strictly observed.
The useful and scattered beams can produce serious or fatal bodily injuries to any person
in the surrounding area if used by an unskilled operator.
Adequate precautions must always be taken to avoid exposure to the useful beam, as well
as to scattered radiation resulting from the passage of radiation through matter.
Those authorized to operate, participate in, or supervise the operation of the equipment
must be thoroughly familiar and comply completely with the current established safe
exposure factors and procedures described in publications, “ Diagnostic x-ray systems and
their major components” and IEC 60601 general and collateral standards as revised or
replaced in the future.
Those responsible for the planning of x-ray and gamma-ray equipment installations must
be thoroughly familiar and comply completely with: “structural shielding design and
evaluation for medical x-ray and gamma-rays od energies up to 10MEV” and IEC-
407”radiation protection in medical x-ray equipment 10kv-400kv” as revised or replaced in
the future.
Failure to observe these warning may cause serious or fatal bodily.
 To prevent electric shock, please observe the following precautions.

 Never open the system’s covers. Hands touching a high-voltage zone inside can
cause electrical shock.
 Avoid installation sites where the system will be exposed to water.
 Always ground the system to a protective earth line.
 Make sure that all connections are secure and connected correctly.
 Do not use water to extinguish a fire when fire occurs in the exposure room.
 Noxious materials may be discharged.
Radiation and X-Ray General Safety Information

Everyone associated with X-Ray work must be familiar with the recommendations of the:
 Center for Devices and Radiological Health (CDRH)
 National Institute of Standards and Technology (NIST)
9
 National Council on Radiation Protection (NCRP), and

 International Committee on Radiation Protection (ICRP)
- Be sure that all personnel authorized to operate the equipment are familiar with the
established regulations of the authorities named above. All personnel should be
monitored to ensure compliance with the above.
- Although X-Ray radiation is hazardous, X-Ray equipment does not pose any danger
when properly used. Be certain all operating personnel are properly educated
concerning the hazards of X-Ray radiation.
- Persons responsible for the equipment must understand the safety requirements
and special warnings for X-Ray operation.
- All users must equip with the protective devices in prior to using the equipment.
10
Diagnostic Reference Level

The radiographic examinations using radiation at medical facilities have retained
legitimacy and have applied to medical areas in order to have more benefits on
diagnostic information rather than putting patients in danger.
In addition, for the purpose of optimizing radiation protection, the medical facilities must put
efforts on both minimizing the exposure of radiation to patients and achieving the most
favorable images accordance with the principles of ALARA. The radiation dose on patients
is differentiated depending on part of body, medical institution, and regulation of each
country.
According to a report from UNCEAR, even if patients have a same medical examination,
the radiation dose of what patients receive are from 10 times to 100 times different
depending on medical institution.
Table 1. The recommended radiation dose for patient in examination (IAEA BSS No. 115)
Body part Position ESD/radiograph (mGy)
PA 5
Head
LAT 3
PA 0.4
Chest
LAT 1.5
PA 7
Thoracic vertebrae
LAT 20
PA 10
lumbar LAT 30
OBL 40
Abdomen AP 10
Pelvis AP 10
Femur AP 10
11
Cautions in Radiation Room

During radiation exposures in a radiation room, no one must stay inside except patients
and if there is any particular reason for anyone to stay, the person or people must be
equipped with protective equipments (Shielding) while staying in the room.
The shielding can be classified as protective equipment for operator and patient:
1) Shielding for Operator

For the self-protection of operator, it is mandatory to equip with apron and must
prepare lead gloves, lead glasses, protective cap and protective mask in radiation
room.
2) Shielding for patient

Protect patient from radiation by proofreading position of patient, reduce radiation field,
or cover gonad using a lead plate.
 Upright-bucky protective apron

 Ovarian-shield plate
 Male-gonad shield
12
Target treatment group and diseases

It has been used widely as the first radiation diagnosis method on purpose of diagnosis for
diseases or fracture injuries in orthopedics or internal medicine department. Since
positions of patient on each part require different positions depending on injuries or
diseases which are unable to explain the every demands in this manual, the following
typical positions are explained in this manual.
Treatment group
* Refer diagnostic codes in "ICD-10 Version 2014 site".
Diagnostic body part Diagnostic region Disease code

A15-A19 Tuberculosis
chest Lung Diseases C34 Malignant neoplasm of bronchus
and lung
Abdomen Bowel disease diagnosis K50-52 Non-infective enteritis and colitis
S00-S09 Injuries to head
S10-S19 Injuries to neck
S20-S29 Injuries to thorax
S30-S39 Injuries to the abdomen, lower
back, lumbar, spine and pelvis.
Skull, Cervical, Thoracic,
S40-S49 Injuries to the shoulder and
Rip, Forearm, Elbow,
upper arm
Humerus, Wrist, Hand,
Fracture diagnosis S50-S59 Injuries to the elbow and
Pelvis, Hip, Femur, Knee,
forearm.
Tibia, Coccyx, Lumber,
S60-S69 Injuries to the wrist and hand.
Foot, Ankle
S70-S79 Injuries to the hip and thigh.
S80-S89 Injuries to the knee and lower
leg.
S90-S99 Injuries to the ankle and foot.
13
Contraindications
Expected except group of treatment
For the purpose of diagnosis on diseases using radiation, it is not recommendable for the
listed patients as following on radiation diagnosis.
 Infants under 6 months.

 The female patients in the early stage of pregnancy are not allowed to get
involved with diagnosis on abdominal region.
- Lumbar spin
- Pelvis
- Sacrum and coccyx
- Proximal femur and hip
- Intravenous urogram (IVU)
 Patient with cardiovascular disease or orthosis.
Side effect
1) Exposing high dose of radiation directly to patient's eyeballs might cause eye
diseases.
2) Exposing radiation to infant or pregnant without protection might cause genetic
disorder.
3) Exposing radiation to patient equipped with cardiac pacemaker due to cardiovascular
disease might cause stop of the cardiac pacemaker.
Caution
Operate the equipment outside of its operating environment limits may lead to
malfunction of or damage to the equipment.
14
Identification labels
Identification label on each component is located in different location individually.
Through the labels, it is available to be informed regarding manufacturer and EU
representative and manufactured date with serial numbers and approvals belong to the
product.
Since damages of the identification labels might cause delays on getting service, avoid
from danger causing any damage of the labels.
Figure 1-1 Location of label
15
Figure 1-2 Location of Symbols
16
Table 1-1. Location of labels

No. Label description Label Designs
System Label
1 Side of Equipment
2 Back side of Equipment
3 Location of Collimator
Table 1-1 shows locations of the identification labels on each component.
17
Symbols Information
This manual uses three types of messages to emphasize information or potential risks to
personnel or equipment. To ensure safety, read all Safety Information provided herein and
observe all.
symbols Description
General mandatory action sign

: To signify a mandatory action
Refer to instruction manual/booklet

: To signify that the instruction manual/booklet must be read
General prohibition sign

: To signify a prohibited action
General warning sign

: To signify a general warning
Warning; Radioactive material or ionizing radiation

: To warn of radioactive materials or ionizing radiation
Warning; Laser beam

: To warn of a laser beam
Warning; Electricity
: To warn of electricity
Type B Applied Part
No pushing
: To prohibit pushing against an object
No stepping on surface
: To prohibit pushing against an surface.
18
RED : Warning – immediate response by the OPERATOR is

required
Yellow: Caution – prompt response by the OPERATOR is
Indicator lights and
required
controls
Green: Ready for use
Any other color : Meaning other than that of red, yellow or
green
1, 2: Warning: Yellow
Specified colors in 4: Prohibition: Red
ISO 3864-1 used for 8: Mandatory Action: Blue
safety signs
19
symbol Description ( IEC 60687/IEC 60417 ) Number

"ON" (power)
: To indicate connection to the mains, at least for
Mains switches or their positions, and all those 5007
cases where safety is involved..
"OFF" (power)
: To indicate disconnection from the mains, at
least for mains switches or their positions, and 5008
all those cases where safety is involved..
Alternating current
: To indicate on the rating plate that the
5032
equipment is suitable for alternating current
only; to identify relevant terminals.
X-ray source assembly, emitting
: To indicate the emission or the imminent
emission of X-radiation. 5339
Indication of radiation field by light

: To identify controls for indication of the
radiation field by 5384
light.
Patient, thin
: To indicate a reference to a thin patient.
5389
Patient, normal
: To indicate a reference to a normal patient.
5390
Patient, obese
: To indicate a reference to an obese patient.
5391
20
Packing symbol
Symbol Description ( ISO 7000 ) Number
Fragile, handle
with care 0621
Keep dry
0626
This way up
0623
Temperature limitation
0632
Humidity
limitation 2620
Main label symbol.

Symbol Description ( ISO 15223-1 ) Number
Manufacturer
3082
Authorized representative
in the European Community
Date of manufacture
2497
Serial number
2498
21
Electrical and Mechanical Safety

Only a qualified, authorized Service Provider should replace electrical or mechanical
components.
Electrical Safety
Sources of potentially lethal voltages/currents are physically and electrically isolated from
both the operator and patient by insulated cables and mechanically secured covers and
access panels..
 Do not remove any panels, for any reason.

 Do not expose, in any way, cables or their mating sockets.
Mechanical Safety
The following are mechanical safety precautions:
 Keep fingers, hands and tools clear of moving parts.

 Always maintain observance of the patient position while positioning the
equipment.
 Always maintain observance of other equipment in the area while positioning the
equipment to prevent collision and potential damage.
 Unless specifically instructed, do not operate equipment with any covers
removed.
22
Procedural Safety
The procedures in this manual are designed for the safety of the patient, operator and the
equipment as well as ensuring the acquisition of diagnostic quality images. Failure to follow
the procedures in this manual (or cautions, warnings and notes) can result in potential
health and safety hazards and/or damage to the equipment.
I. X-RAY equipment must be handled by the proper radiologists own radiation devices
licenses. Users must equip with protective equipments protects from the exposure of
radiation and use the radiation exposure measuring device for safety.
II. ULTRA 100HF cannot be used for perspective examination or others does not belong
to the general uses.
III. ULTRA 100HF must be used for diagnosis and cannot be used for treatment.
IV. ULTRA 100HF is a equipment that is in accordance with IEC 60601-1-2 CLASS
TYPE-B.
V. Users cannot arbitrarily change this product and if necessary or unavoidable to
change this product, the product change must be requested to either the headquarter
or sales agencies.
VI. The necessary adjustment for operation is made at factory before shipping out.
VII. If any problem occurs to the product, users immediately stop using the product and
ask for service to either the headquarter or sales agencies.
VIII. In case of combining ULTRA 100HF with other products from other companies, it is
recommended to make an inquiry either to the headquarter or sales agencies.
IX. Ground wires must be used for AC power supply at all times and it is required to use
the approved ground wires and plugs. The plugs must not be dismantled and
disassembling cases of the product must be avoided due to any electric shock may
caused by the AC power supply.
X. Do not use this equipment in the presence of explosive liquid or gas, etc and if such
those are found, do not turn the power ON.
If any explosive liquid or gas is found when the power is ON, do not turn the power OFF
and eliminate the substance first.
Caution
This equipment is not suitable for use in the presence of flammable anesthetic
mixtures with air, oxygen or nitrous oxide.
23
Disposal
This product may contain hazardous substances such as lead. Improper disposal can
cause environmental pollution. When disposing this equipment, please contact
EcoRay Co., Ltd.
Do not dispose some or all of the product without prior consultation should for any
damages caused thereby disposing the product without consulting EcoRay Co., Ltd shall
not be responsible in law.
Warning
Information of WEEE label
- The following information is for EU members :
The use of this symbol indicates that this product should not be treated as
household waste. Do not dispose electrical and electronic equipment into municipal
waste and must be collected separately. Handle this product correctly to prevent
environmental contamination caused by improper handling of waste.
Please contact EcoRay Co., Ltd or sales agency to get more details on disposing the
product.
24
User Maintenance/Servicing
Unless specifically instructed herein, all maintenance and serving of the equipment should
be performed by qualified, authorized Service Providers. None of the electronic assemblies,
cables or mechanical assemblies is user serviceable.
Cleaning and Disinfecting
Some cleaning solutions, disinfectants and other chemicals can be destructive to the
equipment or pose a risk of fire. The manufacturer is not responsible for damages or
injuries that may result from the use of non-authorized chemicals on or near the equipment.
Warning
Do not operate the equipment when cleaning the equipment.
Before cleaning the equipment, please turn the power off.
Caution
Do not spray cleaning solution directly onto the equipment. Moisten a cloth with
a 70% isopropyl alcohol solution for use on plastics and enameled metal. Apply to
patient contact areas after each contact.
Caution
Do not immerse the equipment in liquid, do not use autoclave equipment.
Environmental Safety and Operating Environment

The equipment is designed to operate in ambient air, free of corrosive compounds. The
manufacturer is not responsible for injury or damages resulting from any equipment
exposed to flammable or flame promoting gases (ether, alcohol or an oxygen enriched
environment.
The following environmental conditions are appropriate for the equipment. Operation under
conditions outside of these ranges could damage the equipment.
Warning
Operate the equipment outside of its operating environment limits may lead to
malfunction of or damage to the equipment.
- Use environment of the product
 General Use Environment

Temperature range 10°C ~ 40°C
Relative humidity range 30% ~75% RH
25
 Optimal temperature and humidity

Temperature range 17°C ~27°C
Relative humidity range 40% ~60% RH
- Transportation environment of the product
 Storage and transportation environment

PARAMETER LIMITS
Ambient temperature range -25 to 70 °C
-13 to 158 °F
Relative humidity. 5 to 95%, non-condensing.
Atmospheric pressure range -700 to 3000 meters (1100 to 700 hPa,
825 to 525 mm Hg).
Electromagnetic Compatibility(EMC)
The ULTRA 100HF system complies with the requirements of IEC 60601-1-2:2001
+A1:2004/EN 60601-1-2:2001 +A1:2006 regarding electromagnetic compatibility.
Surrounding equipment shall follow the standard IEC 60601-1-2:2001
+A1:2004/EN 60601-1-2:2001 +A1:2006.
Caution
Mobile telephones or other radiating equipment can interfere with the function of
the ULTRA 100HF and can therefore cause safety hazards.
ULTRA 100HF must be installed in a shield room with more than 20 db on
attenuation factor of electromagnetic waves.
Guidance and manufacturer's declaration - electromagnetic emissions

The ULTRA 100HF system is intended for use in the electromagnetic environment specified below.
The customer or the user of the ULTRA 100HF system should assure that it is used in such an
environment
Emissions test Compliance Electromagnetic environment - guidance
RF emissions Group 1 The ULTRA 100HF system uses RF energy only for its
CISPR 11 internal
function. Therefore, its RF emissions are very low
andd are not likely to cause any interference in nearby
electronic equipment.
RF emissions Class B The ULTRA 100HF system is suitable for use in all
CISPR 11 establishments, other than domestic and those
Harmonic emissions Not applicable directly connected to the public low-voltage power
IEC 61000-3-2 supply network that supplies buildings used for
Voltage fluctuations/ Not applicable domestic purpose. For information purpose the
Flicker emissions IEC system complies with IEC61000-3-11 and is suitable
61000-3-3 for connection to public mains network if the
impedance is 0,32 Ohm or lower
26
Guidance and manufacturer´s declaration - electromagnetic immunity

The ULTRA 100HF is intended for use in the electromagnetic environment specified below. The
customer or the user of the ULTRA 100HF should assure that it is used in such an environment.
IEC 60601 Electromagnetic environment -
Immunity test Compliance level
test level guidance
Electrostatic + 6 kV contact + 6kV contact Floors should be wood, concrete or
discharger (ESD) + 8 kV air + 8 kV air ceramic tile.
IEC 61000-4-2 If floors are covered with synthetic
material, the relative humidity
should be at least 30%.
Electrical fast + 2 kV for power + 2 kV for power Mains power quality should be that
transient/burst IEC supply lines supply lines of a typical commercial or hospital
61000-4-4 + 1 kV for input/ n/a. for input/output environment.
output lines lines
Surge + 1 kV differential + 1 kV differential Mains power quality should be that
IEC 61000-4-5 mode mode of a typical commercial or hospital
+ 2kV common + 2kV common environment.
mode mode
Voltage dips, short <5 % UT <5 % UT Mains power quality should be that
interruptions and (>95 % dip in UT) (>95 % dip in UT) of a typical commercial or hospital
voltage variations for 0,5 cycle for 0,5 cycle environment. If the user of the
on power supply 40 % UT 40 % UT ULTRA 100HF system requires
input lines. (60 % dip in UT) for (60 % dip in UT) for continued
IEC 61000-4-11 5 cycles 5 cycles operation during power mains
70 % UT 70 % UT interruptions ,it is recommended
(30 % dip in UT) for (30 % dip in UT) for that the ULTRA 100HF system be
25 cycles 25 cycles powered
<5 % UT <5 % UT from an uninterruptible power
(>95 % dip in UT) (>95 % dip in UT) supply or battery.
for 5 sec for 5 sec
Power frequency 3 A/m 3 A/m Power frequency magnetic
(50/60 Hz) Fields should be at levels
magnetic field characteristic of a typical
IEC 61000-4-8 location in a typical
commercial or hospital
environment.
NOTE: UT is the A.C. mains voltage prior to application of the test level.
Guidance and manufacturer´s declaration - electromagnetic immunity

The ULTRA 100HF system is intended for use in the electromagnetic environment specified below.
The
customer or the user of the ULTRA 100HF system should assure that it is used in such an
environment.
Immunity test IEC 60601 Compliance Electromagnetic environment -
test level level guidance
Portable and mobile RF communications
equipment should be used no closer to any
part of the ULTRA 100HF system, including
cables,
than the recommended separation distance
calculated from the equation applicable to
the frequency of the transmitter.
Conducted RF 3 Vrms 3 Vrms Recommended separation distance
IEC 61000-4-6 150 kHz to 80 MHz 150 kHz to 80 d = 1, 2 p
MHz
Radiated RF 3 V/m 3 V/m

IEC 61000-4-3 80 MHz to 2,5 GHz 80 MHz to 2,5 d = 1, 2 p 80 MHz to 800 MHz
GHz d = 2, 3 p 800 MHz to 2,5 GHz
where p is the maximum output power
27
rating of the transmitter in watts (W)

according to the transmitter
manufacturer and d is the recommended
separation distance in
meters (m).
Field strengths from fixed RF
transmitters, as determined by an
electromagnetic site survey, a should be
range. b
Interference may occurred 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 100HF system is used exceeds the applicable RF compliance level
above, the ULTRA 100HF system should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as reorienting or relocating the ULTRA 100HF system.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m.
Recommended separation distances between portable and mobile RF communications

equipment and ULTRA 100HF
The ULTRA 100HF system is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the ULTRA 100HF system can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile
RF communications equipment (transmitters) and the ULTRA 100HF system as recommended below,
according to the maximum output power of the communications equipment.
Rated maximum output Separation distance according to frequency of transmitter
power of transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,5 GHz
W d = 1, 17 p d = 0, 35 p d = 0, 7 p
0,01 0,12 0,04 0,07
0,1 0,37 0,11 0,22
1 1,17 0,35 0,7
10 3,69 1,11 2,21
100 11,67 3,5 7
For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in meters (m) can be estimated using the equation applicable to the frequency of the
transmitter, where p is 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.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected
by absorption and reflection from structures, objects and people.
28
Warranty Scope
The warranty is limited to the components for any problems that may occur within a
specified period and it may be excluded from the warranty in the following cases :
 If users use the product with other purposes besides diagnosis or excessively
used or user errors.
 Damages caused by using wrong power.
 Natural disasters such as lightning, earthquakes, hurricanes, flood, and etc.
 If any problem occurs due to exterior renovation or changes particular part of the
product with unknown origin without permission.
 Any damaged product during transportation.
 Any damages due to the external factors such the conditions of use and storage
conditions described in the specification are not satisfied.
 If any products purchased from abnormal route besides the manufacturer or
sales agency is broken or damaged.
Manufacturer’s Responsibility
Allow only authorized, properly trained personnel to operate the equipment. Ensure that
all individuals authorized to use the equipment are aware of the danger of excessive
exposure to X-Ray radiation.
This equipment is sold with the understanding that the manufacturer, its agents, and
representatives do not accept any responsibility for overexposure of patients or
personnel to X-Ray radiation. No responsibility is assumed for any unit that has not been
serviced by qualified authorized service personnel.
29
Operational & Service
ii
30
Introduction
1.1 Introduction
1
ULTRA 100HF is a diagnostic system to obtain the information necessary for the
diagnosis of the patient through the anatomical structure of human body obtained by a film
or an image processing (workstation) after process of examination using radiation
exposure with cassette IP, CR or DR (Portable flat panel).
31
1.2 Description
ULTRA 100HF is a medical diagnostic X-RAY generator equipped with ease-use in indoor
or outdoor and also a product that can be used in applications where requires x-ray
diagnosis.
Specifications subject to change without notice.
Key features :
- Small, light weight and ease of use

- X-ray generating device by high frequency system
- A large output X-ray generating device uses low-power
- Available to memorize shooting conditions (96 APR)
- Use laser pointer for controlling focus
- Automatic current compensation.
- Digital signal input / output detection system
32
1.3 Composition of ULTRA 100HF

The follows are the major composition of ULTRA 100HF must be used with :
I. Control panel (Membrane console)

II. High frequency generator with X-RAY Tube
III. Collimator regulator
IV. Exposure switch
V. Power input cable
1.3.1 Components of ULTRA 100HF

The follows are the components provided to be used with ULTRA 100HF :
I. Portable storage case

II. Operational manual
III. Service manual
IV. Power input cable
V. Exposure switch
Note
The mount for ULTRA 100HF is an option that can be provided according to any
request from customers.
33
1.4 Dimensions
1.4.1 Basic Dimensions
Figure 1-3. ULTRA 100HF Dimensions
34
Figure 1-4. Mount dimension
Caution
It is recommended to fold the portable head when using ULTRA 100HF with the
mount during transportation for safety.
35
1.5 Specification
Specification
Input power 200~240VAC, 50Hz/60Hz
Inverter 80KHz
Inverter Frequency
Filament 40KHz
KV range 40KV~110KV(1KV STEP)
mAs range 0.32mAs~100mAs
Manufacturer TOSHIBA
X-ray tube
Model No. DF-182
Focal spot 1.8mm
Anode heat storage capacity 28KJ
Maximum anode cooling rate 265W
Peak wavelength 650nm

Laser point
Optical power <1mV
Lamp(LED) Over 100 lux
Filtration total Al. equiv. 2.5mm
Weight 18 kg
36
1.6 Abbreviations
% Percent
Btu British Thermal Unit
°C Degree Celsius
CE Communautés Européenes
cm Centimeter
°F Degree Fahrenheit
ga Gauge
hPa Hecto Pascal
inHg Inches Mercury
Kg Kilogram
kJ Kilojoule
M Meter
max. Maximum
min. Minimum
mm Millimeter
kVp Kilo voltage Peak
mAs Milliampere per sec
1.7 Certification Labels

System labels should include information and specifications on the manufacturers of
the product and provide additional information on achieved certificate.
Figure 1-5. Product label
37
Operation
2.1 Safety Precautions

2
Warning
The person in charge who is responsible for installation must follow
regulations of each country.
Warning
If anyone who might operate this product recognizes the unintended
condition of the unit such as mechanical failure, noise, unexpected vibration,
and so on must inform directly to the service engineer in charge.
38
2.2 Specifications
Specifications
Input power 200~240VAC(50Hz/60Hz)
Inverter 80KHz
Inverter Frequency
Filament 40KHz
KV range 40KV~110KV(1KV STEP)
mAs range 0.32mAs~100mAs
Manufacture TOSHIBA
x-ray tube
Model DF-182
Focal spot 1.8mm
Anode heat storage capacity 28KJ
Maximum anode cooling rate 265W
Peak wavelength 650nm
Laser point
Optical power <1mV , Class I
Lamp(LED) Over 100 lux.
Filtration total Al. equiv. 2.5mm
Weight 18 kg
39
2.3 General Description

2.3.1 Safe Distance
The user shall exposure X-ray from minimum of 2 m or more away from the focus on X-ray.
If there is no such separate protective wall for protecting the user from radiations, please
make sure to wear the following safety equipments before the exposure :
- Lead Glass
- Lead gloves
- Lead Apron
- Lead Neck Apron
2m
Figure 2-1. Safety Distance
2.3.2 Power ON/OFF

After connecting the power cable to the connector (1), it is available to turn the power
ON or OFF by the switch (2).
Caution
If any problem occurs after turning the power ON, please reboot of the
equipment. If the problem keep occurring, stop using the equipment and
request for a service.
40
2.3.3 Input Power & Grounding

The power of the ULTRA 100HF uses 200 ~ 240V AC and instead of connecting to the
main power box of wall, ULTRA 100HF has been designed simply to connect to the wall
outlet for the power.
Color of conductors
 brown: L
 blue : N
 green and yellow : GND
Figure 2-2. Input Power & Grounding
41
2.4 Operational Panel Description

The operational panel includes “Display, kVp, mAs, Lamp, Laser pointer, APR” to control the
necessary parts for the shooting.
   
    
 11
12 14 15
13
Figure 2-3. Operation Panel
42
No Name of Button Description
1 X-RAY Ready X-RAY ready status displayed with the LED lamp
2 X-RAY Exposure X-RAY exposure status displayed with the LED lamp
X-RAY exposure availability displayed with the LED lamp after the
3 X-RAY Standby
previous exposure.
4 Error The Light's ON when an error occurs while using the product.
5 Collimator Collimator control ON/OFF button
6 Laser pointer Laser pointer ON/OFF button
7 kVp Display Displays changes of kVp values
8 mAs Display Displays changes of mAs values
9 Display invert Available to invert the values of kVp and mAs
10 kVp Control Controls kVp values depending on body parts
11 mAs Control Controls mAs values depending on body parts
12 Positions Available to select position of patient
13 APR Saving To save the different positions in order to recall by pushing this button.
14 Patient's body part Available to select body parts to be exposed.
It automatically recalls each position depending on each size of

15 Patient's size
patient.
Table 2-1. Description of Operation Panel
43
2.5 Shooting Scope

* The table below is intended be a reference to the user when using ULTRA 100HF.
KV Range 40KV~110KV(1KV STEP)
Range 0.32mAs~100mAs
mAs
0.32, 0.4, 0.5, 0.63, 0.8, 1.0, 1.25, 1.6, 2.0, 2.5, 3.2, 4.0, 5.0, 6.3, 8.0, 10,
STEP 12, 16, 20, 25, 32, 40, 50, 63, 80, 100mAs
Defaults KV mA mAs
100mA 0.32~2.0mAs
80mA 2.5~6.3mAs
40KV~50KV
60mA 8.0~50mAs
50mA 63~100mAs
80mA 0.32~3.2mAs
70mA 3.2~8.0mAs
51KV~60KV
50mA 10~50mAs
40mA 63mAs~100mAs
70mA 0.32~2.5mAs
60mA 4.0~8.0mAs
61KV~70KV
50mA 10~32mAs
35mA 40~100mAs
Allowable 60mA 0.32~1.6mAs
value 40KV/2mAs 50mA 2.5~10mAs
71KV~80KV
40mA 12~32mAs
30mA 40~100mAs
50mA 0.32~1.6mAs
81KV~90KV 40mA 2.0~5.0mAs
30mA 6.3~40mAs
25mA 50~100mAs
50mA 0.32~0.8mAs
40mA 1.0~2.5mAs
91KV~100KV
30mA 3.2~25mAs
20mA 32~100mAs
40mA 0.32~0.8mAs
30mA 1.0~10mAs
101KV~110KV
25mA 12~25mAs
20mA 32~100mAs
Table 2-2. Shooting Scope
2.6 Preparation Before Operation

2.6.1 Safety Precaution
I. All users must equip with protective equipments before using ULTRA 100HF.
II. Keep the safe distance from focus of ULTRA 100HF before shooting.
III. In order to achieve good qualified images with low X-ray dose, it is required to
minimize the shooting area by the collimator.
IV. Warn the patients or people who stays in an infirmary about X-ray exposure
if it's unavoidable to shoot in the infirmary.
V. It is required to have regular checks or periodic maintenance on the product.
44
Caution
Input power of the portable X-RAY equipment must be used in the range of
the input power marked on the equipment within +/- 10%.
The power cable of the product must be separated not to be mixed with
other cables.
Before the exposure of patients using the ULTRA 100HF, it is required to Shoot
3-5 times with low doses (40kvp 5mAs) as warm-up operation to ensure the
safe use.
2.6.2 Check on Collimator & Laser Pointer

I. Collimator is a device to help preventing the unnecessary dose exposed to
patients and it is required to check the shooting range of the patient at all times
before exposures.
II. Laser pointer is a device to help to determine the approximate shooting distance
and when it is not possible measuring the distance between the cassette and the
tube focus on IP with a tape measure or other methods.
III. The collimator lamp is operated by pressing the button and the lamp is lit for 30
seconds when there is no signal of flickering and after that, it flickers.
IV. Collimator light will be lit by pressing the preparation button on the hand switch
and will flash automatically after X-RAY exposure. To remove this function, press
the ON button more than 3 seconds not to light up during X-RAY exposure.
2.7 Manual Operation

I. Turn the power ON and prepare for the shooting.
II. Input the values (kVp, mAs) for the shooting depending on each body part.
III. Check the values (kVp, mAs) whether those are correct before shooting and focus
to the center of the body part and then expose.
IV. The applied values are displayed on the operational panel as the following:
Figure 2-4 Value display
2.7.1 kVp & mAs Control

This control part is to control or to adjust the values (kVp, mAs) required for the shooting
depending on each body part with necessary X-ray dose.
The applicable value range for kVp is 40 kVp~110 kVp and the applicable value range for
mAs is 0.32mAs~100mAs.
45
2.7.2 Lamp & Laser Pointer Control

This is a device to confirm the focus range of the patient and the area to be taken by the
user. Before shooting, it must be done to check the area and focus of the body part by the
lamp and laser pointer on the operational panel.
In addition, the collimator lamp will be ON automatically by pressing "Ready" button and
make sure the patient not to move and press "Exposure" switch to get images.
"Ready" button
"Exposure" button
Figure 2-5. Description of Hand switch button
2.7.3 Exposure Control

There are 2 steps for using the hand switch; "Ready" and "exposure" buttons.
If release the "exposure" button during exposing X-RAY, all procedures will be stopped and
warning light will be ON.
Ready Exposure
Figure 2-6. Exposure Control
46
2.7.4 Mode Selection

1. X-Ray Mode Selection :
There are 2 modes for exposure.

- Time mode : Exposure according to the time chart.
- mAs mode : Exposure depending on selected mAs values.
1) Turn the power ON while pressing kVp DOWN button and kVp UP button
at the same time as following :
 Power “ON”  ( Time mode )
( mAs mode )
* There is no separate button for saving and it automatically saves 3 seconds after
entering the mode.
2. Auto Calibration
- Depending on the equipment input current, it corrects the values such as mA, mAs and kVp
automatically.
1) Turn the power ON while pressing both mAs DOWN button and mAs UP button at the same
time as following :
 Power “ON”  ( Auto Cal. )
2.8 APR Operation

I. Recall the shooting terms previously saved.
II. It recalls the follows; Body size Body part Position.
< APR selection >
III. In order to change the previously saved values, select one of those (the body size, body part
and position) and press the "Memory" button for more than 1 second after changing the kVp
and mAs values.
< APR saving >

Caution
* The filament of the tube should be preheated sufficiently before
shootings for the reliable operation.
* To use again after constant or continuous uses of ULTRA 100HF, it is
available when the standby light is OFF and the high-dose exposure more
than 50mAs requires an interval for 2-3 minutes.
47
2.9 Shooting Terms

The following exposure condition table is only for reference. It can be different with the
conditions actually being used in fields.
Small Mid Large

Positions
kVp mAs SID kVp mAs SID kVp mAs SID
AP 73 14 1m 70 18 1m 75 20 1m
Skull Lateral 70 12 1m 70 14 1m 75 18 1m
Townes 73 18 1m 75 20 1m 80 28 1m
PA 80 8 1.5m 85 10 1.5m 90 10 1.5m
chest AP 80 8 1.5m 85 10 1.5m 90 10 1.5m
Lateral 75 15 1.5m 80 15 1.5m 90 15 1.5m
AP 70 15 1m 70 20 1m 75 25 1m
Rib
Oblique 70 18 1m 70 25 1m 75 32 1m
Clavicle AP 70 15 1m 75 15 1m 75 20 1m
Shoulder AP 60 10 1m 65 12 1m 70 15 1m
Supine 65 20 1m 70 20 1m 70 25 1m
Abdomen
Erect 68 20 1m 75 20 1m 75 25 1m
AP 70 20 1m 75 20 1m 75 25 1m
Pelvis
Lateral 80 28 1m 90 28 1m 95 32 1m
AP 65 15 1m 70 15 1m 75 18 1m
C-Spin
Lateral 75 15 1.5m 80 15 1.5m 85 18 1.5m
AP 70 15 1m 70 15 1m 75 20 1m
T-Spin
Lateral 75 18 1m 75 20 1m 75 32 1m
AP 75 25 1m 80 32 1m 80 40 1m
L-Spin
Lateral 80 32 1m 85 40 1m 90 50 1m
Finger AP 40 2 1m 40 2 1m 40 2 1m
Hand AP 43 2 1m 43 3.2 1m 45 4 1m
Wrist AP 50 4 1m 50 5 1m 50 8 1m
Forearm AP 50 5 1m 50 7 1m 50 9 1m
Elbow AP 50 5 1m 50 7 1m 50 9 1m
Humerus AP 55 7 1m 55 9 1m 55 10 1m
Foot AP 50 4 1m 50 7 1m 55 9 1m
Ankle AP 55 8 1m 55 9 1m 55 10 1m
Tibia AP 55 8 1m 60 10 1m 65 12 1m
Knee AP 55 8 1m 60 10 1m 60 12 1m
Femur AP 65 10 1m 70 12 1m 75 15 1m
48
2.10 Radiation Dose Display

ULTRA 100HF has two ways for delivering radiation dose information on patients to users
in the calculation program and to equip with the DAP, the radiation measuring device in
front of a collimator. DAP is provided separately by attaching to the front of the collimator at
a request of the customer.
When there is no customer requests on DAP, the basic calculation program will be
provided as a radiation dose measurement instead of DAP. The calculation of the radiation
dose has been programmed to display measurement results comparing with Vacutec 2004
OEM models. (Refer the following chart)
* Test Distance 1m
Test value Dose Area Calculated value Ultra 100 display value DAP value
kV mAs uGy 가로 세로 uGy*m^2 uGy*m^2 Tolerance(%) uGy*m^2 Tolerance(%)
40 2.5 26.36 0.3 0.3 2.3724 2.5084955 -5.42538335 2.4 -1.163378857
40 5 53.87 0.3 0.3 4.8483 5.01699099 -3.3623938 4.9 -1.066353155
40 10 114.3 0.3 0.3 10.287 10.033982 2.52161118 11.1 -7.903178769
55 2.5 63.17 0.3 0.3 5.6853 5.92828037 -4.09866535 6.2 -9.053172216
55 5 128.3 0.3 0.3 11.547 11.8565607 -2.61088147 12.6 -9.119251754
55 10 261.8 0.3 0.3 23.562 23.7131215 -0.6372906 25.9 -9.922756982
65 2.5 91.72 0.3 0.3 8.2548 8.2799949 -0.30428645 9.1 -10.23889131
65 5 183.3 0.3 0.3 16.497 16.5599898 -0.38037345 18.2 -10.32308905
65 10 369.4 0.3 0.3 33.246 33.1199796 0.38049659 37 -11.29158395
75 2.5 125.8 0.3 0.3 11.322 11.0236619 2.70634343 12.5 -10.40452217
75 5 246.7 0.3 0.3 22.203 22.0473237 0.70610065 24.6 -10.7958384
75 10 489.6 0.3 0.3 44.064 44.0946474 -0.06950369 49.2 -11.65577342
85 2.5 158.2 0.3 0.3 14.238 14.1592812 0.55595179 15.9 -11.67298778
85 5 315.7 0.3 0.3 28.413 28.3185624 0.33348287 31.5 -10.86474501
85 10 646.1 0.3 0.3 58.149 56.6371249 2.66940652 64 -10.06208189
90 2.5 176.1 0.3 0.3 15.849 15.8740731 -0.1579498 17.2 -8.52419711
90 5 354 0.3 0.3 31.86 31.7481461 0.35231621 34.6 -8.600125549
90 10 719 0.3 0.3 64.71 63.4962923 1.91146237 70.5 -8.947612425
100 2.5 213.8 0.3 0.3 19.242 19.5976211 -1.81461346 20.7 -7.57717493
100 5 435.4 0.3 0.3 39.186 39.1952421 -0.02357975 42.4 -8.201908845
100 10 875.2 0.3 0.3 78.768 78.3904843 0.4815836 84.7 -7.530977047
49
2.10.1 DAP Calculation worksheet

Dose display of the ULTRA 100HF is programmed based on the area of 30 x 30 cm may
result in error rates in other areas. Also, in order to know the accuracy of the radiation dose,
please request the comparison measurements to a service engineer. please refer to the
table below calculation method
* The following is an example to help understanding.
Step ACTION RESULT

Measured dose: ____23.3_____ mR
1 Convert mR to mGy if necessary by multiplying mR X
0.00873. Example 23.3 mR X 0.00873 = 0.203 mGy. ____0.203____ mGy
Measure and record the exposed area of the film (Length X ____13.6_____ Length (cm)
2 Width). ____13.2_____ Width (cm)
Calculate the exposed area in cm 2 (length X width). ___179.52____ Area (cm 2)
Multiply the dose in mGy (step 1) X the area in cm 2 (step 2).
3
This will yield the actual dose-area product, in mGycm2 ____36.44____ DAP (mGycm 2)
4 Record the DAP, in mGycm 2, as displayed on the console. ____40_______ DAP (mGycm2)
Calculate the percentage error: Refer to the example at the
5
end of this section. ____-8.9______ % error
Sample percentage error calculation (step 5):

(36.44-40)/40 x 100 = -3.56/40 x 100 = -8.9%
50
Calibration & Adjustment

3
3.1 Introduction
Calibration and adjustment of the product is intended to use and maintain stably and
ULTRA 100HF is calibrated by the manufacturer at the factory, but it is recommended to
calibrate and adjust one or more times at site depending on the environment because the
performances of the product cannot be demonstrated. It is also recommended to do the
periodic adjustment and calibration once a year to maintain stable performances of the
product.
51
3.2 Calibration
3.2.1 Auto kVp
1) Control panel의 Turn the power ON while pressing the "Collimator LED" button.
+ Power “ON”  (FND Display)
2) It matches the input values of kVp SET with output values of kVp Feedback
automatically.
3.2.2 Auto mA
1) It matches the input values of mA SET with output values of mA Feedback
automatically.
2) When it is 100mA output. it automatically adjusts V-F Frequency values
(mAs measured values) to 10,000 Hz.
3) 1 or 2 minutes after the completion of the auto calibration, it automatically
reboots and turns out to be the operational mode.
(FND Display)
3.2.3 Auto-Gain
1) Turn the power ON while pressing the "Collimator Laser" button.
2) When the auto-gain calibration is finished, there is a message shows up, “PUSH” on
the FND. Then press the hand switch with 2 steps, "Ready" and "Exposure".
3) FND on the operational panel displays a message, “OPEN”.

Then release the hand switch.
 
4) 10 seconds of countdown and the auto exposure starts with a message, “OUT” on
the FND of the operational panel. Leave the room within 10 seconds.
52
5) Through 5 times for the each section of kVp and mA, total 35 times of X-ray exposure,
correct the values with the feedback values.
- kVp ranges : 40,50,60,70,80,90,100 kVp

- mA ranges : 20,30,40,50,60,80,100 mA
6) 5 or 6 minutes after the auto calibration, it automatically reboots and becomes the
operation mode.
(FND Display)
3.2.4 Manual kVp
1) Turn the power ON while pressing the "Reverse" button.
2) The Auto kVp calibration runs about 4-5 minutes. Check the progress with the
connected oscilloscope.
3) When the auto kVp calibration is over, FND on the operational panel displays a
message, “PUSH”. Then press the hand switch with 2 steps, "Ready" and "Exposure".
4) FND on the operational panel displays a message, “OPEN”.

Then release the hand switch.
 
5) FND on the operational panel displays, “40” and "0".
53
<Display of kVp> <kVp of gain value>

- Basic values gained : 0
- Range of negative values gained : -1 ~ -5
- Range of positive values gained: 1 ~ 5
6) After the X-ray exposure, check the kVp value measured by the connected instrument
(oscilloscope) and if the kVp value is higher or lower than the set value, adjust the "kVp
gain" value with carrying out manual calibration.
* kVp value range : 1V = 20 kVp
7) If the kVp value measured by the oscilloscope is higher than 40 kVp, press the "kVp
Down" button on the operational panel once. Then the FND displays “40” and “-1” with
exposing X-ray. If you could 40 kVp correctly from the oscilloscope, press the Memory"
button to save the setting.
 
8) If the kVp value measured by the oscilloscope is lower than 40 kVp, press the "kVp UP"
button on the operational panel once. Then the FND displays “40” and “1” with exposing X-
ray. If you could 40 kVp correctly from the oscilloscope, press the Memory" button to save
the setting.
 
9) By saving the setting like above with 40 kVp, then the 50 kVp automatically becomes
changed. Check the each value of 40, 50, 60, 70, 80, 90 and 100kvp and adjust with the
same method.
10) After the adjustments on 40, 50, 60, 70, 80, 90, 100 kVp, it automatically reboots and
ready to operate again as following :
(Manual cal)
* There is no separate button for saving and it automatically saves 3 seconds after
entering the mode.
54
3.3 DR Interface
In case of using wired detector, connect to an external output terminal of the exposure
signal. In order to use the external output terminal, you must first activate the external
output in the ULTRA 100HF.
1. Activating DR interface
Turn the power ON while pressing the "Patient size" buttons. Then “dRP on “ , “dRP off”
messages will be displayed and the DR interface will be activated.
+ POWER “ ON” = “dRP on”
+ POWER “ ON” = “dRP off”
2. Connecting the signal cable

Depending on the signal types of detector, “contact type” and “TTL type”, connect the
cables to use the DR interface.
55
1) Detector Type 1 : Contact type ( Exposure OK signal )
56
2) Detector Type 2 : Voltage output ( Exposure OK signal )
57
3. Description on connecting cables
1) Main board output signal

Basically the output signal type of ULTRA 100HF is contact type and when the detector
signal is connected, it is available to select either 5V or 24V depending on the specification
of the signal of each detector.
2) Product Input signal (Voltage Use)

Basically, the input signal type of ULTRA 100HF is voltage type. when connecting to the
detector signal, if the output signal is either 5V or 24V, the "SEL1" dip switch must be
selected to use.
SEL1 : 1 : ON ( use 24V ) / 2 : ON ( use 5V )
3) Product Input signal ( Contact Use )

If the output signal type of the detector is contact type, connect the ground signal of
ULTRA 100HF to the detector.
* Reference ( Detector Type 1 : Contact type ( Exposure OK signal ) )
58
Troubleshooting
4
4.1 Introduction
This chapter is intended to provide the information about the errors that may occur while
using ULTRA 100HF by displaying the error codes on the FND display so that user can
cope on the errors, but it is recommended to contact the manufacturer or the service
engineer in the event of any error occurs.
4.2 Error Code & Troubleshooting

Users of ULTRA 100HF are obliged to deliver all necessary information with details
including error codes to service engineers if any error occurs. If any error is taken action by
any other person besides the authorized service engineers, please note that the
manufacturer is not responsible for any side effect occurred by the action.
59
ERROR
Symptom Solution
CODE
kV_LIMIT_OVER_ERROR Carry out CALIBRATION & REBOOT,
4 : Occurs when using min. or max. kVp. If the problem still appears, replace the main
(INVERTER FEED BACK) board.
mA_LIMIT_OVER_ERROR Carry out CALIBRATION & REBOOT,
5 : Occurs when using min. or max. mA. If the problem still appears, replace the main
(INVERTER FEED BACK) board.
READY_TIMEOVER_ERROR Replace the hand switch.
: If there is no exposure signal during If the problem still appears, replace the main
7
certain standby time after the input of board.
"READY" signal.
XRAY_TIMEOVER_ERROR Carry out CALIBRATION & REBOOT,
: If there is no exposed X-ray during If the problem still appears, replace the main
8
certain standby time after the input of board.
"Exposure" signal.
NO_EXP_OK_NO SIGNAL_Error Turn the power ON while pressing the patient
: Occurs if DR Interface is not connected.. size (Small) button. Then “dRP off”
9
and "DR interface is not used" messages will
be displayed on the FND display.
OVER_CPU_ERROR Carry out CALIBRATION & REBOOT,
10 : Occurs when using max. mA If the problem still appears, replace the main
board.
ALRAM_CPU_ERROR Carry out CALIBRATION & REBOOT,
20 : Occurs when there is an error on TEMP If the problem still appears, replace the main
or KV. board.
TEMP_FB_CPU_ERROR - If the error occurs when it is "COLD START",
: It occurs when the measured the temperature sensor has a problem so, it is
temperature is higher than the set required to replace the board.
25
temperature or if there is no measure - If the error occurs during operation, just turn
value on the Anode temperature during the power OFF and turn the power ON after
certain standby time. certain time.
MON_kV_OVER_ERROR Carry out CALIBRATION & REBOOT,
: Occurs if there is higher kVp values than If the problem still appears, replace the main
30
the set kVp values. board.
(CONTROL BOARD FEED BACK)
MON_kV_UNDER_ERROR Carry out CALIBRATION & REBOOT,
31 : Occurs if there is lower kVp values than If the problem still appears, replace the main
the set kVp values. board.
MON_mA_OVER_ERROR Carry out CALIBRATION & REBOOT,
: Occurs if there is higher mA values than If the problem still appears, replace the main
40
the set mA values. board.
MON_mA_UNDER_ERROR Carry out CALIBRATION & REBOOT,
: Occurs if there is lower mA values than If the problem still appears, replace the main
41
the set mA values. board.
MON_PRE_mA_OVER_ERROR Carry out CALIBRATION & REBOOT,
: Occurs if there is higher PRE_mA values If the problem still appears, replace the main
50
than the set PRE_mA values. board.
51 MON_PRE_mA_UNDER_ERROR Carry out CALIBRATION & REBOOT,
60
: Occurs if there is lower PRE_mA values If the problem still appears, replace the main
than the set PRE_mA values. board.
SET_mA_ERROR Carry out CALIBRATION & REBOOT,
: Occurs if the CONTROL BOARD cannot If the problem still appears, replace the main
55 output as the value set in mA to the board.
inverter.
SET_kV_ERROR Carry out CALIBRATION & REBOOT,
: Occurs if the CONTROL BOARD If the problem still appears, replace the main
56 cannot output as the value set in KV to board.
the inverter.
FB_START_ERR_ERROR Carry out CALIBRATION & REBOOT,
: Occurs if there is no CURRENT FEED If the problem still appears, replace the main
57 BACK to the inverter for certain time after board.
the input of exposure signal.
OP_COMM_ERROR 1) Reconnect the communication line after
: Occurs when there is a communication turning the power OFF and reboot.
error with external devices 2) If the problem still appears, check the
60
(CONTROL BOARD FEED BACK) cables first.
3) If the problem still appears, replace the
main board.
Rotor_Current_ERROR Replace the ROTOR board.
: Occurs if there is an error on the current
61
of the rotor.
(ROTOR BOARD FEED BACK)
POWER_LEVEL_ERROR Check on the input power if it's correct or
: Occurs when there is an input power move on to another power. If the problem
70 error such as lack of power or higher keeps occurring, replace the main board.
power.
TUBE_TEMP_ERROR - Replace the temperature sensor.
: If there is no measured temperature on - If the error occurs during operation due to
the tube for certain time. high temperature of the tube, turn the power
80 If the measured temperature is higher OFF and turn the power ON after certain time.
than the working temperature.
(CONTROL BOARD or TUBE FEED
BACK)
DC_OUT_ERROR 1) Replace the main board.
90
: Occurs if more than 24 VDC output. 2) Replace the hand switch.
EEPROM_TIMEOVER_ERROR 1) Carry out CALIBRATION & REBOOT,
: Occurs if it is unable to recall the saved 2) If the problem still appears, replace the
100 values or save values. EEPROM.
(CONTROL BOARD FEED BACK) 3) If the problem still appears, replace the
main board.
EEPROM_VALUE_ERROR 1) Carry out CALIBRATION & REBOOT,
: Occurs if the set value is out of the 2) If the problem still appears, replace the
110 range. EEPROM.
(CONTROL BOARD FEED BACK) 3) If the problem still appears, replace the
main board.
61
CALIBRATION_ERROR Carry out CALIBRATION & REBOOT,

150 : Occurs if calibration data has an error. If the problem still appears, replace the main
board.
MAX_POWER_OVER_ERROR Carry out CALIBRATION & REBOOT,
200 : Occurs if the input has an over-current. If the problem still appears, replace the main
board and power board.
Table 4-1. Troubleshooting Code
62
Maintenance
5
5.1 Periodic Maintenance Schedule
Refer to the schedule below for information on when to perform periodic maintenance on
the crane.
Note : Due to varying operating conditions, the procedures listed below may have to be
performed at greater or lesser intervals. You may have to adjust intervals according to your
crane’s performance.
What to do When to do it Section
Clean External Surfaces Every week or as required 5.2
Operational Check Every half year 5.3
Adjustment Every year Chapter 3
63
5.2 Cleaning External Surface

Tools Required:
 Cleaning wipes
 Non-abrasive, hospital-grade cleaner
Warning
All peripheral equipment must be turned off. You could get seriously
injured if you do not.
Warning
This equipment is not classified as anesthetic-proof and may ignite
inflammable anesthetics. Flammable agents used for skin cleaning or
disinfecting may also produce an explosion hazard.
 Ensure the power has been disconnected and that the emergency switches have
been activated, before starting any cleaning operation..
 Ensure no liquid gets into the unit.
 Do not immerse the equipment, including any components or accessories, in
liquid.
 Do not autoclave the equipment, including any component or accessories.
 Do not use water. Water can short-circuit the electrical installation and cause
corrosion to mechanical parts.
 Do not use acid or abrasive products.
 Use only a dry cloth to clean chrome-plated parts.
 For safety reasons, do not spray disinfectants.
 Do not spray cleaning or disinfection solution directly on the equipment.
 When disinfecting the examination room, ensure the unit is covered with plastic
sheets.
64
5.3 Operation Check

The Preventive Maintenance and Operational Check forms are shown in Tables 5-2 & 5-3.
Use these tables as a guide for performing the operational check procedure. A copy of
these forms should be kept with the tube crane’s permanent service documentation.
Warning
All service and maintenance including the procedures described within this
chapter are to be performed by qualified service personnel only.
Warning
This equipment is not classified as anesthetic-proof and may ignite
inflammable anesthetics. Flammable agents used for skin cleaning or
disinfecting may also produce an explosion hazard.
< Semi-Annual Preventive Maintenance Checklist >
Inspection Comments
Check the condition of the collimator lights.
Check the condition of the lever of the collimator.
Check the condition of the laser pointer.
Check the buttons if any of them are not able to be pushed.
Check the cooling fan whether it's working properly or not.
Check the condition of the hand switch.
Check the power cable connector.
Table 5-1 : Semi-Annual Preventive Maintenance
65
< Operational Checklist >
Note : If the product fails any portion of this operational check, stop the operational check
and correct the problem. Once the problem has been corrected, restart the operational
check from the beginning.
Step Pass Fail
Check if there is any problem on the FND Display.
Check if the exposure indicator light is working fine.
Check if the dose values are displayed after the exposure.
Check if the laser pointer and collimator lights are working fine at the "READY" of
the hand switch.
Check if each position is unable to be save with APR.
Check the condition of the angle indicator and if the indicator is working fine
without a problem.
Check if error code is displayed on the screen.
Check if the tube Heat Unit displays fine without a problem.
Check when using DR Interface, if there is any problem or error.
Table 5-2 : Operational Check
66
5.4 END OF PRODUCT LIFE

The Product useful life has been estimated at 10 years from point of sale. This will vary
depending on use and environmental conditions. If the Product has completed its useful
service life, local environmental regulations must be complied with in regard to disposal of
possible hazardous materials used in the construction of the Product.
In order to assist with this determination, the noteworthy materials used in the construction
of this Product are itemized below:
ITEM
 Electrical insulating oil in HT tank. This is a mineral oil with trace additives
(1.5 Litre )
 Solder (lead/tin).
 Epoxy fiberglass circuit board materials, tracks are solder on copper.
 Wire, tinned copper. Insulated with PVC, Insulation Rubber, or silicone.
 Steel and / or aluminum (Product cabinet and console chassis).
 Plastic (console enclosure and console membrane).
 Electrical and electronic components: IC’s, transistors, diodes, resistors,
capacitors, etc.
Caution
Do not disassemble, incinerate or short-circuit the battery(s) in this product.
Do not put it in trash that is disposed of in landfills: dispose of it as required
by local ordinances.
The fluorescent lamp in the LCD display contains mercury. Do not put it in
trash that is disposed of in landfills: dispose of it as required by local
ordinances.
The LCD is made of glass. If the LCD breaks due to rough handing or
dropping, and the internal fluid gets in your eyes or on tour hands,
immediately wash the affected areas with water for at least 15 minutes.
Seek medical attention if any symptoms are present after washing.
67
Electrical Schematics
6
6.1 Introduction
This chapter provides the electrical schematics of ULTRA 100HF.
6.2 List of Schematics
Drawing Current
Drawing Description #Sheets
Number Rev
SYDN-01 Main board 12 V0.8
SYDN-02 Power board 1 V0.4
SYDN-03 Invertor board 1 V0.8
SYDN-04 Tank board 1 V0.1
68
- Block Diagram
69
- Inverter
70
- Main Control
71
72
73
74
75
76
77
78
79
80
81
82
- Power
83
- Tank
84
SPARES Parts List
7.1 INTRODUCTION
7
This chapter contains the list of spare parts for the ULTRA 100HF of Diagnostic
radiography system.
7.2 SPARE PARTS LIST
The matrix on the next page lists the recommended spare parts for the LaVid FMTS
System of Diagnostic radiography system.
Warring : Service or technical problem on ULTRA 100HF must be handled by

the engineers authorized or properly trained by Manufacturer.
Any physical risk or damages due to service or any similar action by any
unauthorized person shall not be responsible to manufacturer.
85
SPARE PARTS LIST
SPARE TABLE
SUGGESTED
DESCRIPTION Part Number NOTE
QTY
Power cable SY-U-001 1
Power connector SY-U-002 1
Power switch SY-U-003 1
DC fan SY-U-004 1
Hand switch SY-U-005 1
Collimator lamp SY-U-006 1
Laser module SY-U-007 1
Noise filter SY-U-008 1
Main board SY-U-009 1
Power board SY-U-010 1
Inverter board SY-U-011 1
Mono block SY-U-012 1
Membrane sheet SY-U -013 1
Interface cable SY-U-014 1
86
EcoRay Co., Ltd

3F, Urbanlight B/D, 630,
Eonju-ro, Gangnam-gu, Seoul, Korea
TEL : +82 70 7510 3403 / FAX : +82 70 8630 3420
87

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ULTRA 100HF (5kw Portable X-Ray)

Operational & Service Manual

EcoRay Co., Ltd.

3F, Urbanlight B/D, 630,

New Release 0.0 Jan 1, 2015

Regulations and standards

Service and Maintenance

Operation, Installation and Repair

DIAGNOSTIC X-ray SYSTEMS RADIATION Cautions

Radiation and X-Ray General Safety Information

Diagnostic Reference Level

Cautions in Radiation Room

Target treatment group and diseases

Electrical and Mechanical Safety

Electromagnetic Compatibility (EMC)

Chapter ii Operational & Service

1.3 Composition of ULTRA 100HF

1.3.1 Components of ULTRA 100HF

1.4.1 Basic Dimensions

1.7 Certification Labels

2.3 General Description

2.3.1 Safety Distance

2.3.2 Power ON/OFF

2.3.3 Input Power & Grounding

2.4 Operational Panel Description

2.5 Shooting Scope

2.6 Preparation Before Operation

2.6.1 Safety Precaution

2.6.2 Check on Collimator with Laser Pointer

2.6.3 Exposure Control

2.6.4 Mode Selection

2.7 APR Operation

2.8 Shooting Terms

2.9 Radiation Dose Display

2.9.1 DAP Calculation worksheet

Chapter 3 Calibration & Adjustment

3.2.1 Auto kVp

3.2.4 Manual kVp

4.2 Error Code Troubleshooting

5.1 Periodic Maintenance Schedule

5.2 Cleaning External Surface

5.3 Operation Check

5.4 END OF PRODUCT LIFE

Chapter6 Electrical Schematic

6.2 List of Schematics

Chapter7 Illustrated Parts List

7.2 Spare Parts List

Regulations and standards

1) EN 60601-1:2006 Medical electrical equipment

3) EN 60601-1-3 : 2008 General Req. for Radiation protection in diagnostic X-ray

guidance of trained health care professionals.

The equipment shall be serviced only by qualified personnel who:

Service and maintenance

Operation, installation and repair

DIAGNOSTIC X-ray SYSTEMS RADIATION Cautions

 To prevent electric shock, please observe the following precautions.

Radiation and X-Ray General Safety Information

 National Council on Radiation Protection (NCRP), and

Diagnostic Reference Level

Body part Position ESD/radiograph (mGy)

Cautions in Radiation Room

1) Shielding for Operator