LG 17HK701G Users manual

Please read this manual carefully before operating your set and

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retain it for future reference.

17HK701G-W

OWNER’S MANUAL

Flat Panel Digital X-ray

Detector

Printed in Korea

www.lg.com

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.

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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 : +31-20-456-3132

LG Electronics Inc.

77, Sanho-daero, Gumi-si, Gyeongsangbuk-do, 39381, Republic of Korea Tel : +82-1544-8777

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

Precautions for Using the Battery

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

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and cause electrical shocks or start a fire.

Integrated Adapter

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

SAFETY INFORMATION

Regulations

Safety Standard

Medical Device Classification

equipment

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.

Class

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)

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

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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)(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

RF Emissions CISPR 11 Group 1 The EUT uses RF energy only for its internal

RF Emissions CISPR 11 Class A The EUT is suitable for use in all Harmonic emissions IEC

A 61000-3-2 Voltage fluctuations/ Flicker

Complies emissions IEC 61000-3-3

Electromagnetic Environment –

Guidance

function. Therefore, its RF emissions are very low and

are not likely to cause any interference in nearby electronic equipment.

establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

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

Test Level

Compliance

Level

Electromagnetic Environment – Guidance

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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

± 8 kV contact ± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air

± 2 kV 100 kHz repetition frequency ± 0,5 kV, ± 1 kV ± 1 kV Mains 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 cycle 0 % UT; 250/300 cycle

30 A/m 30 A/m Power frequency magnetic fields should be at

NOTE

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

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.

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Conducted disturbances induced by RF fields IEC 61000-4-6

Radiated RF EM fields IEC 61000-4-3

Immunity Test

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 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:

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.

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