Elo TouchSystems 2401LM Touchmonitor Manual de usuario

USER MANUAL

Elo Touch Solutions

2401LM Touchmonitor

SW200127 Rev A

SW200127 Rev A - Page 2 of 32

No part of this publication may be reproduced, transmitted, transcribed, stored in a retrieval system, or translated

into any language or computer language, in any form or by any means, including, but not limited to, electronic,

magnetic, optical, chemical, manual, or otherwise without prior written permission of Elo Touch Solutions, Inc.

Disclaimer

The information in this document is subject to change without notice. Elo Touch Solutions, Inc. and itsAffiliates

(collectively "Elo") makes no representations or warranties with respect to the contents herein, and specifically

disclaims any implied warranties of merchantability or fitness for a particular purpose. Elo reserves the right to

revise this publication and to make changes from time to time in the content hereof without obligation of Elo to

notify any person of such revisions or changes.

Trademark Acknowledgments

AccuTouch, CarrollTouch, Elo, Elo (logo), Elo Touch, Elo Touch Solutions, Elo TouchSystems, IntelliTouch, iTouch,

SecureTouch, TouchTools and VuPoint are trademarks of Elo and its Affiliates. Windows is a trademark of Microsoft

Corporation.

SW200127 Rev A - Page 3 of 32

Warnings and Cautions

Warning

• Danger - Explosion hazard. Do not use in the presence of flammable anesthetics, and

other flammable materials.

• To prevent fire or shock hazards, do not immerse the unit in water or expose it to rain

or moisture.

• Do not use the unit with an extension cord receptacle or other outlets unless the

prongs of the power cord can be fully inserted.

• RISK OF ELECTRICAL SHOCK - DO NOT OPEN. To reduce the risk of electrical

shock, DO NOT remove the back of the equipment or open the enclosure. No

user-serviceable parts are inside. Refer servicing to qualified field service engineers

only.

• Uninsulated voltage within the unit may have sufficient magnitude to cause electrical

shock.

• Avoid contact with any part inside the unit.

• This device complies with the electromagnetic emission and immunity standards and

is limited to the standards that are listed on pages 6 and 26. Other devices which are

not designed to withstand emission levels as specified in the medical device

standards may be susceptible to interference from this device. Subjecting the device

to conditions beyond the rated performance capabilities may result in emissions in

excess of the standard. If it is determined that this device produces electromagnetic or

other interference it must be disconnected from power until the cause of the problem

has been determined and resolved. If it is determined that this device is functioning

improperly due to electromagnetic and other interference it must be disconnected

from power until the cause of the problem has been determined and resolved.

• Elo Touch Solutions recommends that after its useful life (or after sustaining

unrepairable damage), customers dispose of the Touchmonitor and its power supply

in an environmentally sound manner. Acceptable methods include the reuse of parts

or whole products and the recycling of products, components, and materials. Please

consult and obey national state, and local laws and ordinances governing the safe

disposal of electronic equipment.

• To avoid risk of electric shock, this equipment must only be connected to supply mains

with protective earth.

This product consists of devices that may contain mercury, which must be recycled or

disposed of in accordance with local, state, or federal laws.

SW200127 Rev A - Page 4 of 32

Caution

Power cord is used as a disconnection device. To de-energize equipment, disconnect

the power cord.

This unit must follow the national requirement and local state laws to dispose unit.

Before connecting the cables to your Elo Touchmonitor, make sure all components

are powered OFF.

Only approved components complying with IEC60601-1 series can be connected to

2401LM touch monitor for Healthcare Applications in Patient Environment. The use of

ACCESSORY equipment not complying with the equivalent safety requirements of this

equipment may lead to a reduced safety of the resulting system. Consideration relating

to the choices of accessory equipment should include: Use of accessory in the patient

environment.· Evidence that the safety certification of the accessory has been

performed in accordance to the appropriate IEC 60601-1 and/or IEC 60601-1-1

harmonized national standard.

For continued safety

- This unit only complies to the above standards if used with a medical grade power

cord.

- A medical grade power supply, such as the one specified, is required for use in a

medical application.

Please do not touch the patient and the Touchmonitor output connecter at the same

time.

Note:

This symbol alerts the user to important information concerning the operation and

maintenance of this unit, which should be read carefully to avoid problems.

This symbol means DC Current.

This symbol means ON/OFF stand-by switch.

Medical and Healthcare Application Disclaimer:

It is the sole responsibility of any person intending to commercialize, market or use any of Elo

Touch Solutions, Inc. or its family of companies ("Elo") products for medical or healthcare

applications to ensure that such product is adequate and appropriate for the person's

intended use and complies with all applicable laws, regulations, codes and standards

including but not limited to the European Union Medical Device Directive, United States

Federal Food, Drug, and Cosmetic Act, regulations of the United States Food and Drug

Administration (FDA), and for obtaining and maintaining any required regulatory approvals

including but not limited to any required market clearances. Elo has not sought nor received

any rulings from the FDA or any other federal, state, or local government agency or notified

body as to the safety, effectiveness or appropriateness of its product for such applications.

Persons intending to evaluate or use Elo's product for medical or healthcare purposes must

rely on their own medical and legal judgment without any representation on the part of Elo.

SW200127 Rev A - Page 5 of 32

Classification

Withrespecttoelectricalshock,fireinaccordancewithANSI/AAMI ES60601-1:2005 and

CAN/CSAC22.2No. 60601-1-08

This Touchmonitor is a Class I (GROUNDED) DEVICE.

These Touchmonitors are classified NO APPLIED PARTS EQUIPMENT.

Protection against harmful ingress of water:

INGRESSPROTECTION(IPX1)

This Touchmonitor shall be classified as ORDINARY EQUIPMENT, not intended or evaluated

for use in the presence of flammable anesthetic mixture with air, oxygen, or nitrous oxide.

Mode of Operation: CONTINUOUS OPERATION.

Environmental conditions for transport and storage

Temp. Operating 0°Cto 40°C

Storage/Transportation -20°Cto 65°C

Humidity (non-condensing)

Operating

20% to 80%

Storage / Transportation 10% to 90%

Altitude Operating 0to3,000m

Storage / Transportation 0to12,192m

2401LM Touchmonitor for Healthcare Applications is intended for general use in hospital environment for data

collection and display for reference. It shall not be used with life-supporting system.

SW200127 Rev A - Page 6 of 32

European Standards and Classifications

Standards: EN 60601-1-2: 2007

The EMC limits and test methods are referred to the following standards:

Emission: Immunity

CISPR11:2009+A1:2010 ED. 5.1(Grp I, Class B) IEC61000-4-2:2008 ED.2.0

AS/NZS CISPR 11: 2011, Grp. 1, Class B IEC61000-4-3:2006+A1:2007 +A2:2010ED.3.2

IEC 61000-4-4: 2012 ED.3.0

EN 61000-3-2: 2006 +A1: 2008+A2: 2009, Class D IEC 61000-4-5: 2005 ED.2.0

IEC 61000-3-3: 2008 IEC 610004-6: 2008 ED.3.0

IEC 61000-4-8: 2009 ED.2.0

IEC 61000-4-11: 2004 ED.2.0

SW200127 Rev A - Page 7 of 32

Guidance and manufacturer’s declaration-electromagnetic immunity for all

EQUIPMENT AND SYSTEMS

Guidance and manufacturer’s declaration-electromagnetic emissions

The 2401LM Touchmonitor for Healthcare Applications is intended for use in the electromagnetic environment

specified below. The customer or the user of the 2401LM Touchmonitor for Healthcare Applications should

assure that it is used in such an environment.

Emissions test Compliance Electromagnetic environment-guidelines

RF emissions

CISPR 11 Group 1 The 2401LM Touchmonitor for Healthcare Applications 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 2401LM Touchmonitor for Healthcare Applications is suitable

for use in all establishments other than domestic and those directly

connected to a low voltage power supply network which supplies

buildings used for domestic purposes.

Harmonics

emissions

IEC 61000-3-2

Class D

Voltage

fluctuations/flicker

emissions

IEC 61000-3-3

Complies

SW200127 Rev A - Page 8 of 32

Guidance and manufacturer’s declaration-electromagnetic immunity for all EQUIPMENT AND

SYSTEMS

Guidance and manufacturer’s declaration-electromagnetic immunity

The 2401LM Touchmonitor for Healthcare Applications is intended for use in the electromagnetic

environment specified below. The customer, or the user of the 2401LM Touchmonitor for Healthcare

Applications, should assure that it is used in such an environment.

Immunity Test

Level IEC 60601 Compliance Level Electromagnetic Environment - Guidelines

Electrostatic

Discharge (ESD)

IEC 61000-4-2

± 6 kV contact

± 8 kV air ± 6 kV contact

± 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

±2 kV for power

supply lines

± 1 kV for

input/output lines

±2 kV for power

supply lines

± 1 kV for input/output

Lines

Mains power quality should be that of a

typical commercial or hospital environment.

Surge

IEC 61000-4-5 ±1kV line(s) to

line(s)

±2kV line(s) to

earth

± 1 kV line(s) to

line(s)

± 2 kV line(s) to earth

Mains power quality should be that of a

typical commercial or hospital environment.

Voltage Dips, Short

Interruption and

Voltage Variations

on Power Supply

Input Lines

IEC 61000-4-11

<5% UT

(>95% dipin UT)

for 0.5 cycle

40% UT

(60% dip in UT)

for 5 cycles

70% UT

(30% dipin UT)

for 25 cycles

<5% UT

(>95% dipin UT)

for 250 cycles

<5% UT

(>95% dipin UT)

for 0.5 cycle

40% UT

(60 %dip in UT)

for 5 cycles

70% UT

(30% dipin UT)

for 25 cycles

<5% UT

(>95% dipin UT)

for 250 cycles

Mains power quality should be that of a

typical commercial or hospital environment.

If the user of the 2401LM Touchmonitor

for Healthcare Applications requires

continued operation during power mains

interruptions, It is recommended that the

2401LM Touchmonitor for Healthcare

Applications be powered from an

uninterruptible power supply or a battery.

Power Frequency

(50/60 Hz)

Magnetic Field

IEC61000-4-8

3A/m 3 A/m Power frequency magnetic fields should be

at levels characteristic of a typical location in

a typical commercial or hospital

environment.

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

SW200127 Rev A - Page 9 of 32

Guidance and manufacturer’s declaration-electromagnetic immunity for all EQUIPMENT AND

SYSTEMS that are not LIFE-SUPPORTING

Guidance and manufacturer’s declaration-electromagnetic immunity

The 2401LM Touchmonitor for Healthcare Applications is intended for use in the electromagnetic

environment specified below. The user of the 2401LM Touchmonitor for Healthcare Applications

should assure that it is used in such an environment.

Immunity Test IEC 60601 Test

Level Compliance

Level Electromagnetic Environment-Guidelines

Conducted RF

Radiated RF

IEC 61000-4-3

3Vrms

3V/m

80 MHz to 2.5

GHz

3Vrms

Portable and mobile RF communications equipment

should be used no closer to any part of the 2401LM

Touchmonitor for Healthcare Applications and should

assure that it is used in such an environment,

including cables, than the recommended separation

distance calculated from the equation applicable to the

frequency of the transmitter. Recommended

separation distance

80MHz to 800 MHz

800 MHz to 2.5GHz

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 metres(m)

Field strengths from fixed RF transmitters, as

determined by an electromagnetic site survey1,

should be less than the compliance level in each

frequency range2.

Interference may occur in the vicinity of equipment

marked with the following symbol:

NOTE 1: At 80 MHz and 800 MHz, 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.

3. 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 2401LM Touchmonitor for Healthcare Applications

is used exceeds the applicable RF compliance level above, the 2401LM Touchmonitor for Healthcare Applications should

be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary,

such as reorienting or relocating the 2401LM Touchmonitor for Healthcare Applications.

4. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 Vrms.

SW200127 Rev A - Page 10 of 32

Recommended separation distances between portable and mobile RF communications equipment

and the 2401LM Touchmonitor for Healthcare Applications for all EQUIPTMENT AND SYSTEMS that are

not LIFE-SUPPORTING

The2401LM Touchmonitor for Healthcare Applications isintendedforuseinanelectromagnetic

environmentinwhichradiatedRFdisturbances are controlled. The customer or the user of the 2401LM

Touchmonitor for Healthcare Applications canhelp prevent electromagnetic interference by maintaininga

minimumdistancebetweenportableandmobileRFcommunications(equipment)andthe2401LM

Touchmonitor for Healthcare Applications 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

150 kHz to 80 MHz

80MHz to 800 MHz

800 MHz to 2.5 GHz

0.01 0.12 0.12 0.23

0.1 0.37 0.37 0.74

1 1.2 1.2 2.3

10 3.7 3.7 7.4

100 12 12 23

Fortransmittersratedatamaximumoutputpowernotlistedabove,therecommendedseparation

distanced in metres (m)canbeestimatedusingtheequationapplicabletothefrequencyofthe

transmitter,wherePisthe maximum output power rating of the transmitter in watts (W) according to the

transmitter manufacturer.

NOTE 1: At 80 MHz and 800 MHz, 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.

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