JPI CUBE X Series User manual

DOC. NO.: JDP-013-CUBEX
Issued Date: 2017.07.21
Revision: 2017.07.21(Rev.0)
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CUBE X Series
Diagnostic X-ray System
(Portable X-ray)
JPI HEALTHCARE Co., Ltd
Woolim e-Biz center 608-ho,28, Digital-ro 33gil, Guro-gu, Seoul, 08377 South Korea
TEL: [phone], FAX: [phone]
Homepage: www.jpi.co.kr
E-mail: lee[email protected]

DOC. NO.: JDP-013-CUBEX
Issued Date: 2017.07.21
Revision: 2017.07.21(Rev.0)
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Revision History
REV No.
Date
Reason for Change
ETC
0
2017.07.21
Preliminary edition
1
2017.10.10
Adding Images for Use

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Manufacturer information
Head Office
Address : 608-ho,28, Digital-ro 33gil, Guro-gu, Seoul, 08377, Republic of Korea
Telephone : [phone]
FAX : [phone]
Website : http://www.JPI.co.kr
Factory
Address : 265, Osongsaengmyeong 1-ro, Osong-eup, heungdeok-gu, Cheongju-si,
Chungcheongbuk-do, 28161, Republic of Korea
Telephone : [phone]
FAX : [phone]-
European representative
Emergo Europe
Address : Prinsessegracht 20 2514 AP The Hague,Netherlands
Telephone : (31) (0) 70 345-8570
EC conformance
This device meets the general requirements according to the specifications of the Medical Device
Directive 93/42/EEC as amended by 2007/47/EC.
© Copyright JPI HEALTHCARE 2017
All rights reserved. Reproduction or transmission in whole or in part, in any form or by a means,
electronic, mechanical or otherwise, is prohibited without the prior written consent of JPI
HEALTHCARE. The manual may be revised without prior notice for the improvement of the device.

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Symbols
The following advisory symbols will be used throughout the manual. Their application and
meaning are described below.
Advice of conditions or situations that, if not heeded or avoided, will
cause serious personal injury or death.
Advice of conditions or situations that, if not heeded or avoided,
could cause serious personal injury or catastrophic damage of
equipment or data.
Advice of conditions or situations that, if not heeded or avoided,
could cause personal injury or damage to equipment.
The following symbols will be used in the product label. Their application and meaning are
described below.
Indicates the medical device manufacturer, as defined in EU
Indicates the date when the medical device was manufactured
Indicates the manufacturer's serial number so that a specific
medical device can be identified
Indicates the Authorized representative in the European
Community
Indicates the need for the user to consult the instructions for use
for important cautionary information such as warnings and
precautions that cannot, for a variety of reasons, be presented on
the medical device itself
TYPE B APPLIED PART complying with the specified requirement
of IEC60601 to provide protection against electric shock,
particularly regarding allowable leakage current.

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This symbol indicates that the waste of electrical and electronic
equipment must not be disposed as unsorted municipal waste and
must be collected separately.
This symbol indicates that user should read instructions for use.
The following symbols will be used in the packing label. Their application and meaning are
described below.
Fragile
Handle with care
This way up
Keep away from rain
Do not use hand hooks

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Accident Reporting
In order to improve the quality of the system and prevent an additional accident, all users of this
equipment, operators and service technicians, are required to provide JPI with the following
information regarding all reportable events as soon as possible:
1) Identification of the model and serial number.
2) Description of the event including any serious injury or death occurred.
3) Identification of the person who is submitting the information including phone number an
d fax number if available.

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1. Safety Information
1.1 Safety guidelines
This Product was designed and manufactured to ensure maximum safety of operation and
to meet all the safety requirements applicable to electronic medical equipment. However,
anyone attempting to operate the system must be fully aware of potential safety hazards.
It should be operated and maintained in strict compliance with the following safety
precautions and operating instruments contained herein:.
1) The product should be installed, maintained and serviced according to JPI HEALTHCARE
maintenance procedures and by JPI HEALTHCARE personal or other qualified
maintenance personnel approved in writing by JPI HEALTHCARE.
2) The system, in whole or in part, cannot be modified in any way without written approval
from JPI HEALTHCARE.
3) Before authorizing any person to operate the system, verify that the person has read the
Service Manual and fully understands it. The owner should make certain that only
properly trained and fully qualified personnel are authorized to operate the equipment.
An authorized operators list should be maintained.
4) All manual have to be kept at hand for authorized operator.
5) The owner should ensure continuously that power can supply product specified voltage
and current to the system.
6) If the product does not operate properly or failure occurred, the operator should contact
to JPI HEALTHCARE field service representative immediately.
7) The user should understand guarantee product specifications and also should not do any
medical diagnosis from out of range.
If a malfunction occurs, do not use this equipment until qualified personnel correc
t the problem.

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1.2 General Hazards
1.2.1 Radiation hazards
1.2.2 Electric shock hazard
1.2.3 Explosion hazard
This system can be used with interfaced to x-ray generating equipment. Be certain to
follow the safety instructions and specifications for wearing proper lead shielding
when in the presence of x-ray generating equipment
The internal circuit of the system uses high voltage that might cause electric shock or
serious injury.
For your safety, the power cable must be connected with ground and all cables and
plugs are approved by UL. Also do not open the system case.
Do not operate the equipment in the presence of flammable or explosive liquids,
vapors or gases.
If flammable substances are detected after the system turned on, evacuate and
ventilate area before turning the system off.

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1.3 Safety Precautions
1.3.1 Owner’s responsibility
Do not use the system if unsafe conditions are known to exist. In case of hardware
failure that could cause hazardous conditions (smoke, fire and etc), turn the power OFF
and unplug the power cords of all subsystems.
The owner has responsible for ensuring that all system users are fully understand service
manual and other relevant literature.
1.3.2 System diagnostic
The owner is responsible for ensuring that diagnostic of system is performed every year.
Do not try to use the system if system diagnostic is fail.
The owner must run calibration software to diagnosis system every year. If the error has
detected, report detailed error to JPI HEALTHCARE field service representative.
1.3.3 Calibration
Verify the system is calibrated to ensure the optimal performances of the system.
The owner has responsibility for ensuring the system calibration when installing system
or repairing system. Using not calibrated system must be forbidden.

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1.3.4 Back up images
If you lost acquired images and take extra acquisition, the patient will be exposed to
additional radiation. The operator has responsible for regular back up images of each
patient.
The operator should back up images because there is always have possibility to losing
images cause by PC failure. Acquire image it not possible when the space of hard disk is not
enough. The operator need to make it sure that hard disk has enough space for taking
images.
1.3.5 User limitations
For your safe installation and using, the Service Mode should be operated by JPI
HEALTHCARE qualified person with password.
1.3.6 Cleaning the system
Use only isopropyl alcohol to clean surfaces of the system. Do not use detergents or
organic solvents to clean the system. Strong detergent, and organic cleaners may
damage the finish and cause structural weakening. Do not clean the system with turning
the power on.

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1.3.7 Overheating
Do not block the ventilation ports to prevent overheating the system that can cause
malfunction and damages
1.3.8 Electrical fire
The system is using high voltage devices and it might make fire because of over
powered, electrical short or overheated.
For your safety, the system must keep distance from flammable gas or something.
Do not place fluids or food on any part of system.
Be sure that fire extinguisher is can be used for electrical fire.
1.3.9 EMI/EMC precaution
The device has been tested for EMI/EMC compliance, but during the installation to
prevent malfunction of device you should keep suitable distance from other electronic
devices or cell phone.
1.3.10 Maintenance precaution
Only person who qualified by JPI HEALTHCARE can do maintenance for system.
1.3.11 Disposal
This product contains harmful materials such as lead. Improper disposal of this product
may result in environmental contamination. When disposing of this equipment, contact

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JPI HEALTHCARE representative.
JPI HEALTHCARE does not assume any responsibility for damage resulting from
disposal of this equipment without consulting JPI HEALTHCARE.
1.3.12 Replace fuse
For prevent risk of fire, fuse must be replaced as only same type and rating when the
power is down.
Use only fuse to meet the specification of the system when you replace fuse with another one.
1.3.13 Appropriation
Don’t make any operation except for the intended purpose.
The system, in whole or in part, cannot be modified in any way without written approval
from JPI HEALTHCARE
1.3.14 Installation and maintenance
Only qualified service person, who have took training from JPI HEALTHCARE should
perform this installation and trouble shooting
Only person who qualified by JPI HEALTHCARE can do installation or trouble shooting and
should do calibration after installing devices or changing generator, X-ray tube or detector.

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1.4 EMC Information
1.4.1 Guidance and manufacturer’s declaration - electromagnetic
emissions
The CUBE X series is intended for use in the electromagnetic environment specified below.
The customer or the user of the CUBE X series should assure that it is used in such an
environment.
Immunity test
Compliance
Electromagnetic environment -guidance
RF Emissions
EN 55011
Group 1
The CUBE X series 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
EN 55011
Class A
The CUBE X series is suitable for use in all
establishments other than domestic and those directly
connected to the public low-voltage power supplies
buildings used for domestic purposes.
The CUBE X series is suitable for use in all
establishments other than 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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1.4.2 Guidance and manufacturer’s declaration - electromagnetic immunity
The CUBE X series is intended for use in the electromagnetic environment specified below.
The customer or the user of the CUBE X series 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
± (2,4,6) kV
Contact
± (2,4,8) 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
±2kV for power
supply lines
± 1kV for
input/output
lines
Mains power quality should be
that of a typical commercial or
hospital environment.
Surge
IEC 61000-4-5
±1kV
differential
mode
±2kV 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
<5% Uт
(>95% dip in
Uт)
for 0.5cycle
40% Uт
(60% dip in Uт )
for 5 cycle
70% Uт
(30% dip in Uт)
Mains power quality should be
that of a typical commercial or
hospital environment. If the user of
the CUBE X series image intensifier
requires continued operation
during power mains interruptions,
it is recommended that the CUBE
X series image intensifier be
powered from an uninterruptible

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IEC 61000-4-11
for 25 cycle
<5% Uт
(<95% dip in
Uт ) for 5 s
power supply or a battery.
Power
frequency
(50/60Hz)
magnetic field
IEC 61000-4-8
3 A/m
Not applicable
Power frequency magnetic fields
should be at levels characteristic of
a typical location in a typical
commercial or hospital
environment.
NOTE Uт is the a.c. mains voltage prior to application of the test level.
1.4.3 Guidance and manufacturer’s declaration - electromagnetic immunity
The DRE140/150 is intended for use in the electromagnetic environment specified below.
The customer or the user of the CUBE X series 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
80MHz
3 V/m
80 MHz to
2.5GHz
3 Vrms
3 V/m
Portable and mobile RF communications
equipment should be used no closer to any
part of the CUBE X series, including cables,
than the recommended separation distance
calculated from the equation applicable to the
frequency of the transmitter.
Recommended separation distance
80 MHz to 800 MHz
800 MHz to 2,5 GHz
Where P is the maximum output power rating

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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
deter-mined by an electromagnetic site
surveya ,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 80MHz and 800MHz, 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 DRE140/150 is
used exceeds the applicable RF compliance level above, the DRE140/150 should be
observed to verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as re-orienting or relocating the DRE140/150.
b- Over the frequency range 150kHz to 80MHz, field strengths should be less than 3 V/m.
1.4.4 Recommended separation distances between portable and mobile
RF communications equipment and the CUBE X series
The is intended for use in an electromagnetic environment in which radiated

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RF disturbances are controlled. The customer or the user of the CUBE X series can help
Prevent electromagnetic interference by maintaining a minimum distance between portable
and mobile RF communications equipment (transmitters) and the CUBE X series as
recommended below, according to the maximum output power of the communications
equipment.
Rated
maximum
output power
of transmitter
[W]
Separation distance according to frequency of transmitter
[m]
150kHz to
80MHz
80MHz to
800MHz
800MHz to
2.5GHz
0.01
0.12
0.12
0.23
0.1
0.38
0.38
0.73
1
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
For transmitters rated at 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 80MHz and 800MHz, 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.
1.5 Expected Service Life
Expected service life of CUBE X series is estimated at 10 years.
But actual life of the system may be shorter than 10 years due to the frequency of use and the
environment of the system. And it does not apply to the system damaged due to the negligence of the
user.

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1.6 Intended Use
The system is intended to be used for human in hospital environment under supervision of
recommended medical practitioner. The purpose of the system is to acquire X-ray digital
images of a patient and show the images to a doctor for diagnosis.
1.6.1 Intended patient profile
a) Weight : under 150kg
b) Height : under 2m
c) Age : all ages
d) Sex : male or female
1.6.2 Intended part of the body
a) head
b) chest
c) spine
d) abdomen
e) pelvis
f) arm and leg
g) hand and foot
1.6.3 Intended user profile
a) Age : Over 20 years old
b) Education : Radiology
c) Knowledge : Human anatomy and operation of X-ray machine
d) Permissible impairments : not allowed
e) Sex : male or female
f) No mental illness

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1.6.4 Intended conditions of use
a) Environment :
- General :
- Hospital use only
- Indoor use only
- Physical :
- System Storage/Transport Environmental Condition
Temperature range: -15°C ~ 55°C
Relative humidity range: 20% ~ 90% (non-condensing)
Atmospheric Pressure range: 50kPa ~ 106kPa
- System Operation Environmental Condition
Temperature range: 10°C ~ 35°C
Relative humidity range: 30% ~ 85% (non-condensing)
Atmospheric Pressure range: 70kPa ~ 106kPa
b) Frequency of use
- up to 100 times a day
c) Mobility
- Stationary only
d) Other conditions
- Not in the place exposed to toxic gas
- Not in the place humidity is high
- Not in the place exposed to steam
- Not in the place water drips
- Not in the place too much dust or sand exist
- Not in the place exposed to oil or fat
- Not in the place exposed to salty air
- Not in the place exposed to explosive gas or dust
- Not in the place excessive vibration or impact exists
- Not in the place the floor is inclined by 0.3 degree or more
- Not in the place power supply voltage changes abnormally
- Not in the place the load of power supply falls down or rises excessively
- Not in the place exposed to direct sunlight

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1.6.5 Operating principle
A radiograph is an X-ray image obtained by placing a part of the patient in front of an X-ray
detector and then illuminating it with a short X-ray pulse. To take an X-ray image, the
operator sets the patient in front of the detector and sets the parameter values of the high
voltage generator to control the intensity of X-ray for each body part. When the operator
presses the exposure switch, a high voltage from the generator is supplied to the X-ray tube.
X-rays from the tube are emitted to the patient. The part of the patient to be X-rayed is
placed between the X-ray source and the detector to produce a shadow of the internal
structure of that particular part of the body. X-rays are partially blocked by dense tissues
such as bone, and pass more easily through soft tissues. This causes bones to appear
lighter than the surrounding soft tissue and it makes contrast of the image. The detector
changes the X-rays coming through the part of the patient to digital signals and makes digital
images. The software in the PC provides the operator with various features to manipulate
the images and shows the images to a doctor to diagnose the patient on the monitor.
1.6.6 Limit of use
The device should be operated by the personnel who are qualified by the hospital authority.