LG 17HK701G Users manual

Please read this manual carefully before operating your set and retain it for future reference.

17HK701G-W

OWNER’S MANUAL

Flat Panel Digital X-ray

Detector

0123

Printed in Korea

www.lg.com

Copyright2017 LG Electronics Inc. All Rights Reserved.

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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.

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 17HK701G-W 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.

EC REP LG Electronics European Shared Service Center B.V.

Krijgsman 1, 1186 DM Amstelveen, The Netherlands Tel : [phone]

LG Electronics Inc.

77, Sanho-daero, Gumi-si, Gyeongsangbuk-do, 39381, Republic of Korea Tel : [phone]

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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.

Item	Min.	Max	Units
Temperature (Storage)	-20	60
Temperature (Operation)	10	35
Humidity (Storage)	0	90	%, Non-condensing, Relative Humidity
Humidity (Operation)	0	80
Pressure (Storage)	50	106	kPa
Pressure (Operation)	70	106	kPa

•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

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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 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

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SAFETY INFORMATION

Safety Standard

Medical Device Classification

	Classification by protection type	Class		equipment
	against Electric Shock
	Classification according to the degree	IP41 (Rating for when the main cable is not attached)
	of protection against ingress of water
	or particulate matter
	Mode of operation	Continuous Operation
	Environment of Use	This equipment is not suitable for use in the presence of
		flammable anesthetic or oxygen.
	Applied Part	Type : BF Type, Location : Front of Detector (only for
		effective area)

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.

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.

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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 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 de e 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 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 restricted to indoor use only within the 5.15 ~ 5.35GHz Band.)

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 Test	Compliance	Electromagnetic Environment –
			Guidance
	RF Emissions CISPR 11	Group 1	The EUT uses RF energy only for its internal
			function.
			Therefore, its RF emissions are very low and
			are not likely to cause any interference in
			nearby electronic equipment.
	RF Emissions CISPR 11	Class A	The EUT is suitable for use in all
	Harmonic emissions IEC	A	establishments, including domestic
	61000-3-2		establishments and those directly connected
	Voltage fluctuations/ Flicker	Complies	to the public low-voltage power supply
	emissions		network that supplies buildings used for
	IEC 61000-3-3		domestic purposes.

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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	IEC 60601-1-2	Compliance	Electromagnetic Environment – Guidance
		Test Level	Level
	Electrostatic discharge (ESD)	± 8 kV contact	± 8 kV contact	Floors should be wood, concrete or ceramic tile. If
	IEC 61000-4-2	± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air	± 15 kV air	floors are covered with synthetic material, the relative
				humidity should be at least 30%.
	Electrical fast transient/burst	± 2 kV	± 2 kV	Mains power quality should be that of a typical
	IEC 61000-4-4	100 kHz repetition frequency	100 kHz repetition frequency	commercial or hospital environment.
	Surge Line-to-line	± 0,5 kV, ± 1 kV	± 1 kV	Mains power quality should be that of a typical
	IEC 61000-4-5			commercial or hospital environment.
	Surge Line-to-ground	± 0,5 kV, ± 1 kV, ± 2 kV	± 2 kV
	IEC 61000-4-5
	Voltage dips	0 % UT; 0,5 cycle	0 % UT; 0,5 cycle	Mains power quality should be that of a typical
	IEC 61000-4-11	At 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315°	At 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315°	commercial or hospital environment. If the user of the EUT image
				intensifier requires continued operation during power mains
		0 % UT; 1 cycle	0 % UT; 1 cycle	interruptions, it is recommended that the EUT image intensifier
		and 70 % UT; 25/30 cycles	and 70 % UT; 25/30 cycles	be powered from an uninterruptible power supply or a battery.
		Single phase: at 0°	Single phase: at 0°
	Voltage interruptions	0 % UT; 250/300 cycle	0 % UT; 250/300 cycle
	IEC 61000-4-11
	RATED power frequency	30 A/m	30 A/m	Power frequency magnetic fields should be at
	magnetic fields (50/60Hz)			levels characteristic of a typical location in a typical
	IEC 61000-4-8			commercial or hospital environment.

NOTE

• UT is THE A.C mains voltage prior to application of the test level.

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	Immunity Test	IEC 60601-1-2	Compliance	Electromagnetic Environment – Guidance
		Test Level	Level
	Conducted	3 V	3 V	Portable and mobile RF communications equipment should be used no closer to any part of the EUT,
	disturbances	0,15 MHz – 80 MHz	0,15 MHz – 80 MHz	including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the
	induced by RF fields	6 V in ISM bands	6 V in ISM bands	transmitter.
	IEC 61000-4-6	between 0,15 MHz and	between 0,15 MHz and
		80 MHz	80 MHz	Recommended separation distance:
		80 % AM at 1 kHz	80 % AM at 1 kHz
	Radiated RF EM	3 V/m	3 V/m
	fields	80 MHz – 2,7 GHz	80 MHz – 2,7 GHz
	IEC 61000-4-3	80 % AM at 1 kHz	80 % AM at 1 kHz
				80 MHz to 800 MHz
				800 MHz to 2.7 GHz
				Where P is the maximum output power rating of the transmitter in watts(W) according to the transmitter manufacturer and d is
				the recommended separation distance in 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:

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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	ENGLISH
	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.

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