Please read this manual carefully before operating your set and retain it
0197
for future reference.
14HK701G-W
OWNER’S MANUAL
Flat Panel Digital
X-ray Detector
FCC ID : BEJ14HK701G
IC : 2703H-14HK701G
0123
Copyright
Printed in Korea
www.lg.com
2017 LG Electronics Inc. All Rights Reserved.
Please note that this information is for proper use and safety of the equipment. The following symbols may
indicate a hazardous situation in which, if not needed, may result in serious injury or even death to the user or
others, or damage to the equipment.
ENGLISH
Indicates warning and safety instructions. If not adhered to, it could result in death or
serious injury to the user or others.
WARNING
Indicates a hazardous situation which, if not heeded, may result in minor or moderate
injury to the user or others, or damage to the equipment.
CAUTION
For users in the United States
• United State federal law restricts this equipment to be used by or on the order of a physician.
• Since the X-ray exposure condition can be changed depending on the age, gender and bone density of
the patient, in case of Pediatric, X-ray exposure condition can be changed by expert’s judge. For further
information, please refer to FDA Pediatric X-ray Imaging webpage. http://www.fda.gov/radiationemittingproducts/radiationemittingproductsandprocedures/medicalimaging/ucm298899.htm
For users in other countries
• This equipment is to be used by or on the order of a licensed person under the related laws for each country.
WARNING
• To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective
earth.
• Do not modify this equipment without authorization of the manufacturer.
Intended use
• The Flat Panel Digital X-ray Detector is indicated for digital imaging solution designed for general radiographic
system for human anatomy. It is intended to replace film or screen based radiographic systems in all general
purpose diagnostic procedures. Not to be used for mammography.
Target Population
• No limitation
Target Disease and Target Area
• Bone fractures and breaks
• Scoliosis (abnormal curvature of the spine)
• Non-cancerous and cancerous bone tumors
• Lung problems, such as pneumonia and lung cancer
• Heart problems, such as heart failure
• Breast cancer
Authorized representative in the European community.
ECREP
LG Electronics European Shared Service Center B.V.
Krijgsman 1, 1186 DM Amstelveen, The Netherlands
Tel : +31-20-456-3132
LG Electronics Inc.
77, Sanho-daero, Gumi-si, Gyeongsangbuk-do, 39381, Republic of Korea
Tel : +82-1544-8777
2
SAFETY PRECAUTION
Please read these safety precautions carefully before using the product.
WARNING
• Do not leave any material that may cause fire in the vicinity of the detector.
• Please clean foreign material using dry cloth.
• Using any adapter or cable other than those provided with the product may result in malfunction.
• Unauthorized disassembly or reassembly of the product may result in electric shock or malfunction of the
product.
• Be careful when handling the detector. Do not drop or knock the product.
• If the product emits smoke or strange odors during use, turn off the power immediately and remove the plug.
• For your safety, when cleaning the detector, turn off the detector and unplug the power cable.
• If the product is defective, do not attempt to repair it yourself. Instead, contact the Supplier
• Always use the detector on a flat surface to prevent bending or damage.
• Make sure that the connecting parts of the detector are out of reach of patients.
• Do not apply excessive weight to the detector.
- The detector may be damaged if the entire surface of the detector is subjected to a weight of 150 kg or more.
- The detector may be damaged if the center of the detector is subjected to a weight of 100 kg or more.
CAUTION
• Always use the detector in places that meet the following environmental requirements.
• Do not use the detector in the following places:
- Places that are damp or in direct sunlight
- Dusty places
- Hot and humid places
- Frozen places
- Unstable places, such as those subject to severe vibrations or noise
- Places with devices that generate a strong magnetic field
- Any other place that may compromise the lifespan or performance of the detector
• Do not spray detergents, etc. onto the detector. Always wear gloves when cleaning the detector
ENGLISH
3
Precautions for Using the AC adapter
Do not use the AC adapter when it is in an excessively bent position.
If the AC adapter cable is used for long periods while bent, it could cause internal wiring to become severed and
ENGLISH
cause electrical shocks or start a fire.
Integrated Adapter
Precautions for Using the Battery
This product can be battery-powered. When you are using this product for the first time after purchase, install
batteries in the product and plug it into power to charge the batteries.
• The battery is a consumable component. Its usable capacity reduces gradually over long-term use.
• For battery replacement, please make sure to contact the designated manufacturer.
• Please refer to the manual for instructions on how to remove and replace the battery.
• Always use batteries approved and certified by manufacturer.
- Failure to do so may cause a fire or explosion.
• Do not store the product in an enclosed space (bags, etc.) with the power on repeatedly or for long periods.
- Overheated batteries may cause fire.
• Do not expose the product to flames.
- This may result in explosion or fire.
• Keep the product away from metallic objects, such as car keys and paper clips, when storing or moving.
- Excess current may cause a rapid temperature increase, resulting in fire or burns.
• Contact the manufacturer if the battery leaks or emits an odor.
- Otherwise, it may cause explosion or fire.
• Do not recharge the product using a power supply or circuit other than the one supplied with the product.
- This may damage the battery or cause a fire
Detachable Adapter
4
SAFETY INFORMATION
Safety Standard
Medical Device Classification
Class
Classification by protection type
against Electric Shock
Classification according to the degree
of protection against ingress of water
or particulate matter
Mode of operation
Environment of Use
Applied Part
NOTE
• Additional equipment connected to medical electrical equipment must comply with the respective IEC or ISO
standards (e.g. IEC 60950-1 for data processing equipment).
• Furthermore all configurations shall comply with the requirements for medical electrical systems (see clause 16
of the 3.1Ed. of IEC 60601-1, respectively).
• Anybody connecting additional equipment to medical electrical equipment configures a medical system and is
therefore responsible that the system complies with the requirements for medical electrical systems.
• Attention is drawn to the fact that local laws take priority over the above mentioned requirements.
• If in doubt, consult manufacturer.
equipment
IP41 (Rating for when the main cable is not attached)
Continuous Operation
This equipment is not suitable for use in the presence of
flammable anesthetic or oxygen.
Type : BF Type, Location : Front of Detector (only for effective
area)
Regulations
Safety and Electromagnetic Compatibility Information
This equipment has been tested and found to comply with the limits for medical devices in IEC 60601-1-2. These
limits are designed to provide reasonable protection against harmful interference in a typical medical installation.
This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This
device may not cause harmful interference, and (2) this device must accept any interference received, including
interference that may cause undesired operation.
Note : This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant to
part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference
when the equipment is operated in a commercial environment.
This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in
accordance with the instructions manual, may cause harmful interference to radio communications.
Operation of this equipment in a residential area is likely to cause harmful interference in which case the user will
be required to correct the interference at his own expense.
Changes or modifications not expressly approved by the party responsible for compliance could void the user's
authority to operate the equipment.
This device comply with RF exposure requirements.
ENGLISH
5
Canadian Compliance
This radio transmitter has been approved by Industry Canada to operate with the antenna types listed below with
the maximum permissible gain and required antenna impedance for each antenna type indicated. Antenna
types not included in this list,having a gain greater than the maximum gain indicated for that type, are strictly
ENGLISH
prohibited for use with this device.
Under Industry Canada regulations, this radio transmitter may only operate using an antenna of a type and
maximum(or lesser) gain approved for the transmitter by Industry Canada. To reduce potential radio interference
to other users, the antenna type and its gain should be so chosen that the equivalent isotropically radiated power
(e.i.r.p) is not more than that necessary for successful communication.
This device complies with Industry Canada license-exempt RSS standard(s).
Operation is subject to the following two conditions:
(1) this device may not cause interference, and (2) this device must accept any interference, including
interference that may cause undesired operation of the device.
Le présent émetteur radio a été approuvé par Industrie Canada pour fonctionner avec les types d'antenne
énumérés ci-dessous et ayant un gain admissible maximal et l'impédance requise pour chaque type d'antenne.
Les types d'antenne non inclus dans cette liste, ou dont le gain est supérieur au gain maximal indiqué, sont
strictement interdits pour l'exploitation de l'émetteur.
Conformément à la réglementation d'Industrie Canada, le présent émetteur radio peut fonctionner avec une
antenne d'un type et d'un gain maximal (ou inférieur) approuvé pour l'émetteur par Industrie Canada. Dans le
but de réduire les risques de brouillage radioélectrique à l'intention des autres utilisateurs, il faut choisir le type
d'antenne et son gain de sorte que la puissance isotrope rayonnée équivalente (p.i.r.e.) ne dépasse pas l'intensité
nécessaire à l'établissement d'une communication satisfaisante.
Le présent appareil est conforme aux CNR d'Industrie Canada applicables aux appareils radio exempts de licence.
L'exploitation est autorisée aux deux conditions suivantes :
(1)l'appareil ne doit pas produire de brouillage, et (2) l'utilisateur de l'appareil doit accepter tout brouillage
radioélectrique subi, même si le brouillage est susceptible d'en compromettre le fonctionnement.
This device is retricted to indoor use only within the 5.15~5.35GHz.
This device comply with RF exposure requirements.
Cet appareil est limite a une utilisation en interieur uniquement dans les limites de 5.15 ~ 5.35 GHz.
Cet appareil est conforme aux exigences d'exposition RF.
This device can be operated in at least one Member State without infringing applicable
requirements in the use of radio spectrum.
This device is compliant with the RED article 10.10 requirement because the information is
available on the package.
This device is retricted to indoor use only within the 5.15~5.35GHz.
Electro-Magnetic Compatibility Information
Electro-Magnetic Emissions
This EUT is intended for use in the electromagnetic environment specified below.
The customer or the user of the EUT should assure that it is used in such an environment.
Immunity TestCompliance
RF Emissions CISPR 11Group 1The EUT uses RF energy only for its internal
RF Emissions CISPR 11Class AThe EUT is suitable for use in all establishments,
Harmonic emissions IEC
61000-3-2
Voltage fluctuations/ Flicker
emissions
IEC 61000-3-3
A
Complies
Electromagnetic Environment –
Guidance
function.
Therefore, its RF emissions are very low and are
not likely to cause any interference in nearby
electronic equipment.
including domestic establishments and those
directly connected to the public low-voltage
power supply network that supplies buildings
used for domestic purposes.
6
Electro-Magnetic Immunity
This EUT is intended for use in the electromagnetic environment specified below. The customer or the user of the EUT should assure that it is used in such an environment.
Immunity Test
Electrostatic discharge (ESD)
IEC 61000-4-2
Electrical fast transient/burst
IEC 61000-4-4
Surge Line-to-line
IEC 61000-4-5
Surge Line-to-ground
IEC 61000-4-5
Voltage dips
IEC 61000-4-11
Voltage interruptions
IEC 61000-4-11
RATED power frequency
magnetic fields (50/60Hz)
IEC 61000-4-8
± 0,5 kV, ± 1 kV± 1 kVMains power quality should be that of a typical
± 0,5 kV, ± 1 kV, ± 2 kV± 2 kV
0 % UT; 0,5 cycle
At 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315°
0 % UT; 1 cycle
and 70 % UT; 25/30 cycles
Single phase: at 0°
0 % UT; 250/300 cycle0 % UT; 250/300 cycle
30 A/m30 A/mPower frequency magnetic fields should be at
NOTE
• UT is THE A.C mains voltage prior to application of the test level.
IEC 60601-1-2
Test Level
Compliance
Level
± 8 kV contact
± 15 kV air
± 2 kV
100 kHz repetition frequency
0 % UT; 0,5 cycle
At 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315°
0 % UT; 1 cycle
and 70 % UT; 25/30 cycles
Single phase: at 0°
Electromagnetic Environment – Guidance
Floors should be wood, concrete or ceramic tile. If
floors are covered with synthetic material, the relative
humidity should be at least 30%.
Mains power quality should be that of a typical
commercial or hospital environment.
commercial or hospital environment.
Mains power quality should be that of a typical
commercial or hospital environment. If the user of the EUT image
intensifier requires continued operation during power mains
interruptions, it is recommended that the EUT image intensifier be
powered from an uninterruptible power supply or a battery.
levels characteristic of a typical location in a typical
commercial or hospital environment.
ENGLISH
7
ENGLISH
Immunity Test
Conducted
disturbances
induced by RF fields
IEC 61000-4-6
Radiated RF EM
fields
IEC 61000-4-3
IEC 60601-1-2
Test Level
3 V
0,15 MHz – 80 MHz
6 V in ISM bands
between 0,15 MHz and
80 MHz
80 % AM at 1 kHz
3 V/m
80 MHz – 2,7 GHz
80 % AM at 1 kHz
Compliance
Level
3 V
0,15 MHz – 80 MHz
6 V in ISM bands
between 0,15 MHz and
80 MHz
80 % AM at 1 kHz
3 V/m
80 MHz – 2,7 GHz
80 % AM at 1 kHz
Electromagnetic Environment – Guidance
Portable and mobile RF communications equipment should be used no closer to any part of the EUT,
including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
Recommended separation distance:
80 MHz to 800MHz
800 MHz to 2.7GHz
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 meters(M).
Field strengths from fixed RF transmitters as determined by an electromagnetic site survey, should be less than the compliance level in
each frequency range.
Interference may occur in the vicinity of equipment marked with the following symbol:
8
NOTE
• At 80 MHz and 800 MHz, the higher frequency range applies.
• These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
1 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 EUT is used exceeds the
applicable RF compliance level above, the EUT should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the EUT.
2 Over the frequency range 150 KHz to 80 MHz, field strengths should be less than [V1] V/m.
ENGLISH
9
Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment
• If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna and the ME EQUIPMENT or ME SYSTEM may be reduced to 1 m. The 1 m test distance is permitted by IEC 61000-4-3.
a) For some services, only the uplink frequencies are included.
b) The carrier shall be modulated using a 50 % duty cycle square wave signal.
c) As an alternative to FM modulation, 50 % pulse modulation at 18 Hz may be used because while it does not represent actual modulation, it would be worst case.
ENGLISH
11
ENGLISH
0197
0123
Symbols
SymbolsDescriptions
Refer to instruction manual/ booklet
SymbolsDescriptions
UL classified mark of medical equipment as to electrical shock, fire and
mechanical hazards only in accordance with ANSI/AAMI ES60601-1 (2005) +
E486403
AMD 1 (2012),CAN/CSA-C22.2 No. 60601-1 (2014)
Manufacturer
Alternate current
Direct current
Protective earth (Ground)
Stand-by Symbol.
Off (power : disconnect from the main switch)
On (power : connect from the main switch)
Warning
Caution
SN
ECREP
Date of manufacture
BF applied part
Serial number
Non-ionizing radiation
WEEE : Waste Electrical and Electronic Equipment
Authorized representative in the European community.
The Official Mark Of Europe Certificate
Temperature limit
12
SymbolsDescriptions
IPN
1N2
Humidity limitation
Pressure limitation
For the customers in the U.S.A. Caution
Federal law (United States of America) restricts this device to sale by or on the
order of a licensed healthcare practitioner.
Ingress of protection
Warning
WARNING: To avoid the risk of electric shock, this equipment must only be connected to a supply mains with
protective earth.
Connection
Do not connect the detector with anything other than specified.
Otherwise, it may result in fire or electric shock.
To avoid the risk of electric shock, this detector must only be connected to supply
mains with protective earth.
Handling
Always be sure to keep checking the condition of the system and the patient to
ensure they are normal during the use of the detector. If any problem is found, take
appropriate measures, such as stopping the operation of the detector, as required.
Never disassemble or modify the detector as it may result in fire or electric shock.
Also, since the detector incorporates parts that may cause electric shocks and other
hazardous parts, touching them may cause death or serious injury.
Do not hit or drop the detector. The detector may be damaged if it receives a strong
jolt, which may result in fire or electric shock if the detector is used without being
repaired.
The operator must not touch connectors of the detector and the patient
simultaneously.
The product has lower breaking capacity type. So do not install at the building
power system prospective short-circuit current exceeding 35 A.
ENGLISH
13
ENGLISH
Caution
Environment of Use and Storage
Do not install the detector in a location with the conditions listed below.
Otherwise, it may result in failure or malfunction, cause fire or injury.
• Close to facilities where water is used.
• Where it will be exposed to direct sunlight.
• Close to air-conditioner or ventilation equipment.
• Close to heat source such as a heater.
• Prone to vibration
• Insecure place.
• Dusty environment.
• Saline or sulfurous environment.
• High temperature or humidity.
• Freezing or condensation.
Do not place the storage case in a location with the conditions listed below.
• Where the cable of the detector unit will be strongly pulled when the detector
is put into the case, otherwise, the cable may be damaged, resulting in fire or
electric shock.
• Where someone might get their foot caught in the cable of the detector.
Handling
For safety reasons, be sure to turn off the power of each equipment when detector
is not used.
Location of Cables
Make sure all cables are located so that they cannot be stepped on, tripped over, or
otherwise subjected to damage or stress.
Maintenance and Inspection
If the detector is defective, do not disassemble the detector randomly. Maintenance
of the detector should be done by an manufacturer.
Do not install the ME Equipment in a location without easy disconnect accessibility.
If you have any problem when change the IT-Network, Don't action and please
contect the manufacture.
MANUFACTURER will make available on request circuit diagrams, component part
lists,
descriptions, calibration instructions, or other information that will assist SERVICE
PERSONNEL to repair those parts of ME EQUIPMENT
Indications
The device is intended to capture for display radiographic images of human
anatomy including both pediatric and adult patients. This device is used for
generating diagnostic images by converting x-rays into electronic signals. Excluded
from the indications for use are mammography.
Contraindications
The device is designed to be integrated into a complete X-ray system by qualified
system integrator.
The device is not intended to be used as a primary barrier to X-rays.
Before using the X-ray system please refer to the regulation in force in your area
concerning paediatric patients, pregnant women and anyone with health issues
that contraindicate the use of X-rays. Investigate and make sure of this condition
before starting the exposure.
Clinical Risks and Benefits
There is always a slight chance of cancer from excessive exposure to radiation.
However, the benefit of an accurate diagnosis far outweighs the risk.
• Be sure to connect the cables to the proper connectors. Otherwise, the detector may malfunction or may be
damaged.
• The power supply provided by LG is designed for the detector from LG. Please contact LG, if any other t ype of
power supply is needed to be used.
Handling
• Handle the detector carefully, as it may become damaged if it is hit, dropped, or receives a strong jolt.
16
• Be sure to use the detector on a flat place so it will not bend. Otherwise, the detector may be damaged.
• Be sure to check the detector daily and confirm that it works properly. Sudden heating of the room in cold
areas will cause condensation to form on the detector. In this case, wait until condensation disappears before
performing exposure. If the detector is used with condensation formed on it, problems may occur in the quality
of the detector. When an air-conditioner is going to be used, be sure to raise/lower the temperature gradually
so that a difference in temperature in the room and in the detector does not occur, to prevent forming of
condensation. Follow the recommended proper Room temp.
• Do not use the detector near devices generating a strong magnetic field. Doing so may produce image noise
or artifacts.
• Keep the connectors free from being in contact with the patient.
• Connectors are intended to be connected to an external device and must follow IEC standards.
• Do not apply excessive weight to the detector. O therwise, the detector may be damaged.
Overall Pressure: 150kg (330.6lb) over the whole area of detector window.
Partial Pressure: 100kg (220.4lb) on an area 40mm (1.5 inch) in diameter
Disinfection and Cleaning
• Do not spray disinfectants or detergents on the detector.
• When cleaning the detector, be sure to turn off the power, and unplug the power cable from the AC outlet.
• Do not use any flammable chemicals such as thinner, benzene for cleaning. Otherwise, fire or electric shock
may result.
• Wear waterproof gloves to protect your hands from direct contact with disinfectants or detergents.
ENGLISH
17
OPEN SOURCE SOFTWARE NOTICE
INFORMATION
ENGLISH
To obtain the source code under GPL, LGPL, MPL, and other open source licenses, that is contained in this product,
please visit
http://opensource.lge.com
In addition to the source code, all referred license terms, warranty disclaimers and copyright notices are available
for download.
LG Electronics will also provide open source code to you on CD-ROM for a charge covering the cost of performing
such distribution (such as the cost of media, shipping, and handling) upon email request to
This offer is valid for three (3) years from the date on which you purchased the product.
.
GENERAL DESCRIPTION
Overview
14HK701G is Flat Panel Digital X-ray Detector that can generate images of any part of the body, and designed for
a faster approach to digital radiography systems.
This model utilize a combination a amorphous silicon TFT and high performance scintillator, along with a pixel
pitch 140 um and 3.6 lp/mm of resolution, assure sharp and high contrast image quality.
14HK701G is X-ray imaging acquisition device that is based on flat-panel. This device should be integrated with
an operating PC and a X-ray generator. It can do to utilize as digitalizing X-ray images and transfer for radiography
diagnostic. Data transmission between detector and PC is possible by wire (cable) or wireless.
opensource@lge.com
Product Component
• Detector: 14HK701G
• Control Box : LG Control Box
- AC power cord for Control Box
• Battery Charger : LG Battery Charger
- 2 Battery packs
- AC Power adapter for Charger : 65 W
- AC Power cord for AC Power adapter
• Cable
.
- Main Cable : Detector and Control Box link cable (Supply DC power, Ehternet data, control signals of X-ray
generator)
- Trigger Cable: X-ray generator to Control Box, transmit control signal between detector and X-ray generator.
(Optional)
- LAN cable: Control Box to PC, exchanges Ethernet data between PC and detector. (Optional)
• CD: User’s manual, Calibration Software
• User's manual(book type), Inspection Report
18
Basic Accessories
100kg
Installation CD 1 EAMain cable 1EAManual 1 EAAC Power adapter 1 EA
ENGLISH
Detector 1 EABattery 2 EAAC Power cord for AC Power adapterInspection Report 1EA
Charger 1 EA Control Box 1EAAC Power cord for Control Box 1EA
19
Optional Accessories
ENGLISH
Trigger Cable 1EALAN cable 1EA
• Optional accessories can not be included in accordance with production suffix.
CAUTION
• Need to use the authorized components about the below accessories. Unauthorized components may be cause of the damage and malfunction of the product.
ComponentStandard
LAN CABLEMore than CAT5E Standard
Power CordUS – Approved Medical grade regulation
Others – Approved country safety regulation
The AC/DC adaptors and etc. except the upper components need to be used only supplied by manufacturer.
20
Loading...
+ hidden pages
You need points to download manuals.
1 point = 1 manual.
You can buy points or you can get point for every manual you upload.