LG 19HK312C-B.AUB User manual

www.lg.com

19HK312C

OWNER’S MANUAL

MEDICAL MONITOR

Please read this manual carefully before operating

your set and retain it for future reference.

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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 heeded, may result in serious injury or even death to the user

or others, or damage to the equipment.

WARNING

Indicates warning and safety instructions. If not adhered to, it could result

in death or serious injury to the user or others.

CAUTION

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.

For users in the United States

• United State federal law restricts this equipment to be used by or on the order of a physician.

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

• This Medical Monitor is intended to provide color displays and images from various medical imaging

systems.

EC REP

Authorized representative in the European community.

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

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SAFETY INFORMATION

Safety Standard

Medical Device Classification

Classification by protection type

against Electric Shock Class equipment

Mode of operation Continuous Operation

Environment of Use This equipment is not suitable for use in the presence of

flammable anesthetic or oxygen.

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 equipment generates, uses and can radiate radio frequency energy. If not installed and used in

accordance with the instructions, it may cause harmful interference to other devices in the vicinity.

However, there is no guarantee that interference will not occur in a particular installation. If this equipment

does cause harmful interference to other devices, which can be determined by turning the equipment off

and on, the user is encouraged to try to correct the interference by one or more of the following measures.

• Reorient or relocate the equipment.

• Increase the separation between the equipment.

• Connect the equipment into an outlet on a circuit different from that to which the other devices are

connected.

• Contact manufacturer or authorized agent for help.

Radio Frequency compliance

FCC (For USA)

FCC NOTICE

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.

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FCC CAUTION

Changes or modifications not expressly approved by the party responsible for compliance could void

the user’s authority to operate the equipment. This transmitter must not be co-located or operated in

conjunction with any other antenna or transmitter.

FCC WARNING

This equipment may generate or use radio frequency energy changes or modifications to this equipment

may cause harmful interference unless the modifications are expressly approved in the instruction manual.

The user could lose the authority to operate this equipment if an unauthorized change or modification is

made.

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 of this equipment in a residential area is likely to cause harmful interference in which cause the

user will be required to correct the interference at his own expense.

For Europe

DECLARATION OF CONFORMITY

The complete Declaration of Conformity may be requested through the following postal address:

LG Electronics European Shared Service Center B.V., Krijgsman 1, 1186 DM Amstelveen, The Netherlands

or can be requested at our dedicated DoC website:

http://www.lg.com/global/support/cedoc/cedoc#

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 establishments,

including 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

Voltage fluctuations/ Flicker

emissions

IEC 61000-3-3

Complies

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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 Test Level Compliance Level Electromagnetic Environment – Guidance

Electrostatic discharge

(ESD)

IEC 61000-4-2

± 8 kV contact

± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air

± 8 kV contact

± 15 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

± 2 kV

100 kHz repetition frequency

± 2 kV

100 kHz repetition frequency

Mains power quality should be that of a typical commercial or

hospital environment.

Surge Line-to-line

IEC 61000-4-5

± 0,5 kV, ± 1 kV ± 1 kV Mains power quality should be that of a typical commercial or

hospital environment.

Surge Line-to-ground

IEC 61000-4-5

± 0,5 kV, ± 1 kV, ± 2 kV ± 2 kV

Voltage dips

IEC 61000-4-11

0 % UT ; 0,5 cycle

At 0°, 45°, 90°, 135°, 180°, 225°, 270°

and 315°

0 % UT ; 0,5 cycle

At 0°, 45°, 90°, 135°, 180°, 225°, 270°

and 315°

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.

0 % UT ; 1 cycle

and

70 % UT ; 25/30 cycles

Single phase: at 0°

0 % UT ; 1 cycle

and

70 % UT ; 25/30 cycles

Single phase: at 0°

Voltage interruptions

IEC 61000-4-11

0 % UT ; 250/300 cycle 0 % UT ; 250/300 cycle

RATED power frequency

magnetic fields (50/60Hz)

IEC 61000-4-8

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

of a typical location in a typical commercial or hospital

environment.

NOTE

• UTis the A.C mains voltage prior to application of the test level.

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Immunity Test IEC 60601-1-2

Test Level

Compliance

Level Electromagnetic Environment – Guidance

Conducted disturbances

induced by RF fields

IEC 61000-4-6

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

0,15 MHz – 80 MHz

6 V in ISM bands

between 0,15 MHz and

80 MHz

80 % AM at 1 kHz

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:

Radiated RF EM fields

IEC 61000-4-3

3 V/m

80 MHz – 2,7 GHz

80 % AM at 1 kHz

3 V/m

80 MHz – 2,7 GHz

80 % AM at 1 kHz

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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

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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Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment

Test frequency

(MHz)

Band

(MHz) Service Modulation

Maximum

power

(W)

Distance

(m)

IMMUNITY

TEST LEVEL

(V/m)

385 380 –390 TETRA 400 Pulse modulation 18 Hz 1,8 0,3 27

450 430 – 470 GMRS 460,

FRS 460 FM ± 5 kHz deviation 1 kHz sine 2 0,3 28

710

704 – 787 LTE Band 13,

17 Pulse modulation 217 Hz 0,2 0,3 9

745

780

810

800 – 960

GSM 800/900,

TETRA 800,

iDEN 820,

CDMA 850,

LTE Band 5

Pulse modulation 18 Hz 2 0,3 28

870

930

1 720

1 700 – 1 990

GSM 1800;

CDMA 1900;

GSM 1900;

DECT;

LTE Band 1, 3,

4, 25; UMTS

Pulse modulation 217 Hz 2 0,3 28

1 845

1 970

2 450 2 400 – 2 570

Bluetooth,

WLAN,

802.11 b/g/n,

RFID 2450,

LTE Band 7

Pulse modulation 217 Hz 2 0,3 28

5 240

5 100 – 5 800 WLAN 802.11

a/n Pulse modulation 217 Hz 0,2 0,3 95 500

5 785

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NOTE

• 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.