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.
Disclaimer
The information in this document is subject to change without notice. Elo
Touch Solutions Inc. Elo Touch Solutions 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
Touch Solutions reserves the right to revise this publication and to make
changes from time to time in the content hereof without obligation of Elo Touch
Solutions to notify any person of such revisions or changes.
Trademark Acknowledgments
AccuTouch, Elo TouchSystems, Elo TouchSystems (logo), Elo, IntelliTouch,
iTouch, Elo Touch Solutions, and Elo Touch Solutions (logo) are trademarks.
Windows is a trademark of Microsoft Corporation. Other product names
mentioned herein may be trademarks or registered trademarks of their
respective companies. Elo Touch Solutions claims no interest in trademarks
other than its own.
M-Series Touchcomputer User Guide iii
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 41 and 45.
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 touchcomputer 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.
• Do not modify this equipment without authorization of the manufacturer.
This product consists of devices that may contain mercury, which must be recycled
or disposed of in accordance with local, state, or federal laws.
M-Series Touchcomputer User Guide iv
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 touchcomputer, make
sure all components are powered OFF.
Only approved components complying with IEC 60601-1 series can be
connected to 15MX/19MX Touchcomputer 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 touchcomputer output
connecter at the same time.
The touchmonitor is to be used with following adaptor:
1. XP Power / AHM85PS12
or
2. Elo Touch Solutions / FSP110-RAAM
Disposing of your old product
Within the European Union
EU-wide legislation, as implemented in each Member State, requires that
waste electrical and electronic products carrying the mark (left) must be
disposed of separately from normal household waste. This includes monitors
and electrical accessories, such as signal cables or power cords. When you
need to dispose of your display products, please follow the guidance of your
local authority, or ask the shop where you purchased the product, or if
applicable, follow any agreements made between yourself and the supplier of
this product.
The mark on electrical and electronic products only applies to the current
European Union Member States.
Elo Touch Solutions recommends that after its useful life (or after sustaining
unrepairable damage), customers dispose of the touchcomputer 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.
M-Series Touchcomputer User Guide v
Explanation of Symbols:
• 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.
• Consult instructions for use.
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. 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.
M-Series Touchcomputer User Guide vi
Classification
E354528
07EG
With respect to electrical shock, fire in accordance with ANSI/AAMI ES60601-1 and
CAN/CSA-C22.2 No. 60601-1
This touchcomputer is a Class I (GROUNDED) DEVICE.
This touchcomputer is classified NO APPLIED PARTS EQUIPMENT.
Protection against harmful ingress of water:
INGRESS PROTECTION (IP21)
This touchcomputer 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
Storage / Transportation
0°C to 35°C
-30°C to 60°C
Humidity (non-condensing)
Storage / Transportation 5% to 95%
Operating 20% to 80%
Altitude
Storage / Transportation 0 to 12,192m
Operating 0 to 2,000m
15MX/19MX Touchcomputer 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
For full Product Specifications refer to Appendix C
M-Series Touchcomputer User Guide vii
European Standards and Classifications
Standards: EN 60601-1-2: 2007
The EMC limits and test methods are referred to the following standards:
Guidance and manufacturer’s declaration-electromagnetic
immunity
for all EQUIPMENT AND SYSTEMS
Guidance and manufacturer’s declaration-electromagnetic
emissions
The 15MX/19MX Touchcomputer for Healthcare Applications is intended for use in the
electromagnetic environment specified below. The customer or the user of the 15MX/19MX
Touchcomputer for Healthcare Applications should assure that it is used in such an
environment.
Emissions test Compliance Electromagnetic environment-guidelines
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Group 1
Class A
Not applicable
Complies
The 15MX/19MX Touchcomputer 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.
The 15MX/19MX Touchcomputer for Healthcare
Applications is suitable for use in all establishment
other than domestic and those directly connected
to a low voltage power supply network which
supplies buildings used for domestic purposes.
M-Series Touchcomputer User Guide ix
t
t
r
Guidance and manufacturer’s declaration-electromagnetic
immunity
for all EQUIPMENT AND SYSTEMS
Guidance and manufacturer’s declaration-electromagnetic immunity
The 15MX/19MX Touchcomputer for Healthcare Applications is intended for use in the electromagnetic
environment specified below. The customer, or the user of the 15MX/19MX Touchcomputer for Healthcare
Applications, should assure that it is used in such an environment.
Immunity Test IEC 60601 Compliance Level
±
Electrostatic Discharge
(ESD)
IEC 61000-4-2
Electrical Fast
Transient/Burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage Dips, Short
Interruption and Voltage
Variations on Power
Supply Input Lines
IEC 61000-4-11
6 kV contact
±
8 kV air
±
2 kV for power
supply lines
±
1 kV for input/outpu
lines
±
1 kV line(s) to
line(s)
±
2 kV line(s) to earth
<5% UT
(>95% dip in UT)
for 0.5 cycle
40% UT
(60% dip in UT)
for 5 cycles
70% UT
(30% dip in UT)
for 25 cycles
<5% UT
(>95% dip in UT)
for 250 cycles
±
6 kV contact
±
8 kV air
2 kV for power supply
lines
±
1 kV for input/outpu
lines
±
1 kV line(s) to
line(s)
±
2 kV line(s) to earth
<5% UT
(>95% dip in UT)
for 0.5 cycle
40% UT
(60 % dip in UT)
for 5 cycles
70% UT
(30% dip in UT)
for 25 cycles
<5% UT
(>95% dip in UT)
for 250 cycles
Electromagnetic EnvironmentGuidelines
Floors should be wood,
concrete or ceramic tile. If floors
are covered with synthetic
material, the relative humidity
Mains power quality should be
that of a typical commercial or
hospital environment.
Mains power quality should be
that of a typical commercial or
hospital environment.
Mains power quality should be
that of a typical commercial or
hospital environment. If the user
of the 15MX/19MX Touchcompute
for Healthcare Applications
requires continued operation
during power mains interruptions,
It is recommended that the
15MX/19MX Touchcomputer for
Healthcare Applications be
powered from an uninterruptible
power supply or a battery.
Power Frequency
(50/60 Hz) Magnetic
Field
IEC 61000-4-8
NOTE UT is the A.C. mains voltage prior to application of the test level.
3 A/m 3 A/m
Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical commercial
or hospital environment.
M-Series Touchcomputer User Guide x
e
e
Guida nce and ma nufa ctur er’s declaration-electromagnetic immunity
for all EQUIPMENT AND SYSTEMS that are not LIFE-SUPPORTING
Guidance and manufacturer’s declaration-electromagnetic immunity
The 15MX/19MX Touchcomputer for Healthcare Applications is intended for use in
the electromagnetic environment
Touchcomputer for Healthcare Applications should assure that it is used in such an
environment.
Immunity TestIEC 60601Compliance
Conducted RF
Radiated RF
IEC 61000-4-3
3 Vrms
3 V/m
80 MHz to 2.5
GHz
specified
Level
3 Vrms
3 Vrms
below. The user of the 15MX/19MX
Electromagnetic
Environment-Guidelines
Portable and mobile RF
communications equipment should be
used no closer to any part of the
15MX/19MX Touchcomputer for
Healthcare Applications and should
assure that it is used in such an
environment, including cables, than th
recommended separation distance
calculated from the equation applicabl
to the frequency of the transmitter.
Recommended separation distance
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
transmitters, as determined by an
electromagnetic site survey
be less than the compliance level in
each frequency range
Interference may occur in the
vicinity of equipment marked with
the following symbol:
80MHz to 800 MHz 800 NHz to 2.5GHz
fixed
2
.
RF
1
, should
M-Series Touchcomputer User Guide xi
.
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 15MX/19MX
Touchcomputer for Healthcare Applications is used exceeds the applicable RF compliance
level above, the 15MX/19MX Touchcomputer 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 15MX/19MX
Touchcomputer for Healthcare Applications.
4. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 Vrms
M-Series Touchcomputer User Guide xii
Recommended separation distances between portable
and mobile RF
communications equipment and the 15MX/19MX Touchcomputer for Healthcare
Applications for all EQUIPTMENT AND SYSTEMS that are not
LIFE-SUPPORTING
The 15MX/19MX Touchcomputer for Healthcare Applications is intended for use in an electromagnetic
environment in which radiated RF disturbances are controlled. The customer or the user of the
15MX/19MX Touchcomputer for Healthcare Applications can help prevent electromagnetic interference
by maintaining a minimum distance between portable and mobile RF communications (equipment)
and the 15MX/19MX Touchcomputer 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
0.0
1
0.
1
1 1.
13. 3.7.4
10
0
For transmitters rated at a maximum output power not listed above, the recommended separation
distanced in metres (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the 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.