Mortara ELI 150 Rx User manual

ELI 150 Rx
12-LEAD RESTING ELECTROCARDIOGRAPH
REF 9515-167-51-ENG REV C1
USER MANUAL
Manufactured by Mortara Instrument, Inc., Milwaukee, Wisconsin U.S.A.
CAUTION: Federal law restricts this device to sale by or on the order of a physician.

Copyright © 2008
by Mortara Instrument, Inc.
7865 N. 86th Street
Milwaukee, Wisconsin 53224
This document contains confidential information that belongs to Mortara Instrument, Inc. No part of this document
may be transmitted, reproduced, used, or disclosed outside of the receiving organization without the express written
consent of Mortara Instrument, Inc. Mortara is a registered trademark of Mortara Instrument, Inc. E-Scribe, E I, and
VERITAS are trademarks of Mortara Instrument, Inc. Cisco®is the registered trademark of Cisco Systems, Inc.
DICOM®is the registered trademark of the National Electrical Manufacturers Association for its standards
publications relating to digital communications of medical information. 1.40.

Sales Support/
Supplies & Accessories
Mortara Instrument, Inc.
7865 North 86th Street
Milwaukee, WI 53224
U.S.A.
Tel: [phone]
ax: 414.354.4760
E-mail: [email protected]
Mortara Instrument Germany
Kaninenberghöhe 50
45136 Essen
Germany
Tel: [phone]
ax: +49.201.18 55 69 77
Mortara Instrument Netherlands
Postbus 324
5680 AH Best
Randweg 4
5683 CL Best
Netherlands
Tel: [phone]
ax: +31.499.377908
Mortara Instrument Australia
PO Box 7568
Unit 11, 7 Inglewood Place
Baulkham Hills NSW 2153
Australia
Tel: [phone]
ax: [phone]
Headquarters
Mortara Instrument, Inc.
7865 North 86th Street
Milwaukee, WI 53224
U.S.A.
Tel: [phone]
Tel: [phone]
ax: 414.354.4760
Internet: http://www.mortara.com
European Union
Representative
Mortara Rangoni Europe, Srl
(European Headquarters)
Via Cimarosa 103/105
40033 Casalecchio di Reno (BO)
Italy
Tel: [phone]
ax: +39.051.613.3582
Service/Technical
Support Group
Mortara Instrument, Inc.
7865 North 86th Street
Milwaukee, WI 53224
U.S.A.
Tel: [phone]
Service: 888.MORTARA
(888.667.8272)
ax: 414.354.4760
E-mail: [email protected]
24-Hour Technical Support
Same-Day Shipment of Replacement Parts
Biomedical Training Classes
Extended Warranties/Service Contracts
TECHNICAL SUPPORT AND SERVICE
i

NOTICES
Manufacturer’s Responsibility
Mortara Instrument, Inc. is responsible for the effects on safety and performance only if:
• Assembly operations, extensions, readjustments, modifications, or repairs are carried out only by persons
authorized by Mortara Instrument, Inc.
• The device is used in accordance with the instructions for use.
Responsibility of the Customer
The user of this device is responsible for ensuring the implementation of a satisfactory maintenance schedule.
ailure to do so may cause undue failure and possible health hazards.
Equipment Identification
Mortara Instrument, Inc. equipment is identified by a serial and reference number on the back of the device.
Care should be taken so that these numbers are not defaced.
Copyright and Trademark Notices
This document contains information that is protected by copyright. All rights are reserved. No part of this
document may be photocopied, reproduced, or translated to another language without prior written consent
of Mortara Instrument, Inc.
Other Important Information
The information in this document is subject to change without notice.
Mortara Instrument, Inc. makes no warranty of any kind with regard to this material including, but not limited
to, implied warranties of merchantability and fitness for a particular purpose. Mortara Instrument, Inc. assumes
no responsibility for any errors or omissions that may appear in this document. Mortara Instrument, Inc. makes
no commitment to update or to keep current the information contained in this document.
ii

Your Mortara Warranty
MORTARA INSTRUMENT, INC. (hereinafter referred to as “Mortara”) hereby warrants that Mortara
products (hereinafter referred to as “Product/s”) shall be free from defects in material and workmanship under
normal use, service, and maintenance for the warranty period of such Product/s from Mortara or an authorized
distributor or representative of Mortara. The warranty period is defined as twelve (12) months following the date
of shipment from Mortara. Normal use, service, and maintenance means operation and maintenance in
accordance with appropriate instructions and/or information guides. This warranty does not apply to damage to
the Product/s caused by any or all of the following circumstances or conditions:
a) reight damage;
b) Parts and/or accessories of the Product/s not obtained from or approved by Mortara;
c) Misapplication, misuse, abuse, and/or failure to follow the Product/s instruction sheets and/or information guides;
d) Accident; a disaster affecting the Product/s;
e) Alterations and/or modifications to the Product/s not authorized by Mortara;
f) Other events outside of Mortara's reasonable control or not arising under normal operating conditions.
THE REMEDY UNDER THIS WARRANTY IS LIMITED TO THE REPAIR OR REPLACEMENT
WITHOUT CHARGE OR LABOR OR MATERIALS, OR ANY PRODUCT/S OUND UPON
EXAMINATION BY MORTARA TO HAVE BEEN DE ECTIVE. This remedy shall be conditioned upon
receipt of notice by Mortara of any alleged defects promptly after discovery thereof within the warranty period.
Mortara's obligations under the foregoing warranty will further be conditioned upon the assumption by the
purchaser of the Product/s (i) of all carrier charges with respect to any Product/s returned to Mortara's principal
place or any other place as specifically designated by Mortara or an authorized distributor or representative of
Mortara, and (ii) all risk of loss in transit. It is expressly agreed that the liability of Mortara is limited and that
Mortara does not function as an insurer. A purchaser of a Product/s, by its acceptance and purchase thereof,
acknowledges and agrees that Mortara is not liable for loss, harm, or damage due directly or indirectly to an
occurrence or consequence therefrom relating to the Product/s. If Mortara should be found liable to anyone
under any theory (except the expressed warranty set forth herein) for loss, harm, or damage, the liability of
Mortara shall be limited to the lesser of the actual loss, harm, or damage, or the original purchase price of the
Product/s when sold.
EXCLUDED ROM THE LIMITED WARRANTY SET ORTH ABOVE ARE CONSUMABLE ITEMS
SUCH AS PAPER, BATTERIES, ELECTRODES, PATIENT CABLES, LEAD WIRES, AND MAGNETIC
STORAGE MEDIUMS.
EXCEPT AS SET ORTH HEREIN WITH RESPECT TO REIMBURSEMENT O LABOR CHARGES,
A PURCHASER'S SOLE EXCLUSIVE REMEDY AGAINST MORTARA OR CLAIMS RELATING TO
THE PRODUCT/S OR ANY AND ALL LOSSES AND DAMAGES RESULTING ROM ANY CAUSE
SHALL BE THE REPAIR OR REPLACEMENT O DE ECTIVE PRODUCT/S TO THE EXTENT
THAT THE DE ECT IS NOTICED AND MORTARA IS NOTI IED WITHIN THE WARRANTY
PERIOD. IN NO EVENT, INCLUDING THE CLAIM OR NEGLIGENCE, SHALL MORTARA BE
LIABLE OR INCIDENTAL, SPECIAL, OR CONSEQUENTIAL DAMAGES, OR OR ANY OTHER
LOSS, DAMAGE, OR EXPENSE O ANY KIND, INCLUDING LOSS O PRO ITS,WHETHER UNDER
TORT, NEGLIGENCE OR STRICT LIABILITY THEORIES O LAW, OR OTHERWISE. THIS
WARRANTY IS EXPRESSLY IN LIEU O ANY OTHER WARRANTIES, EXPRESS OR IMPLIED,
INCLUDING, BUT NOT LIMITED TO THE IMPLIED WARRANTY O MERCHANTABILITY AND
THE WARRANTY O ITNESS OR A PARTICULAR PURPOSE.
WARRANTY INFORMATION
iii

USER SAFETY INFORMATION
Means there is the possibility of personal injury to you or others.
Means there is the possibility of damage to the device.
Provides information to further assist in the use of the device.
• This manual gives important information about the use and safety of this device. Deviating from operating
procedures, misuse or misapplication of the device, or ignoring specifications and recommendations could
result in increased risk of harm to users, patients and bystanders, or damage to the device.
• Device (electrocardiograph, Class I) captures and presents data reflecting a patient’s physiological condition
that when reviewed by a trained physician or clinician can be useful in determining a diagnosis;. however, the
data should not be used as a sole means for determining a patient’s diagnosis.
• Users are expected to be licensed clinical professionals knowledgeable about medical procedures and
patient care, and adequately trained in the use of this device. Before attempting to use this device for
clinical applications, the operator must read and understand the contents of the user manual and other
accompanying documents. Inadequate knowledge or training could result in increased risk of harm to
users, patients and bystanders, or damage to the device.
• To ensure that electrical safety is maintained during operation from AC (~) power, the device must be
plugged into a hospital-grade outlet.
• To maintain designed operator and patient safety, peripheral equipment and accessories used that can come
in direct patient contact must be in compliance with UL 60601-1, IEC 60601-1, and IEC 60601-2-25. Only
use parts and accessories supplied with the device and available through Mortara Instrument, Inc.
• Patient cables intended for use with the device include series resistance (9 Kohm minimum) in each lead for
defibrillation protection. Patient cables should be checked for cracks or breakage prior to use.
• Conductive parts of the patient cable, electrodes, and associated connections of type C applied parts,
including the neutral conductor of the patient cable and electrode, should not come into contact with other
conductive parts including earth ground.
• ECG electrodes could cause skin irritation; patients should be examined for signs of irritation or inflammation.
• To avoid the possibility of serious injury or death during patient defibrillation, do not come into contact with
device or patient cables. Additionally, proper placement of defibrillator paddles in relation to the electrodes
is required to minimize harm to the patient.
• This device was designed to use the electrodes specified in this manual. Proper clinical procedure must be
employed to prep the electrode sites and to monitor the patient for excessive skin irritation, inflammation, or
other adverse reactions. Electrodes are intended for short-term use and should be removed from the patient
promptly following testing.
iv
Warning:
Warning(s)
Caution:
Note:

• To avoid potential for spread of disease or infection, single-use disposable components (e.g., electrodes)
must not be reused. To maintain safety and effectiveness, electrodes must not be used beyond their
expiration date.
• To ensure the safety of both the patient and the device, 1.5 meters (5’) of open area should surround
the patient.
• A possible explosion hazard exists. Do not use the device in the presence of a flammable anesthetic mixture
with air or with oxygen or nitrous oxide.
• Where the integrity of external protective earth conductor arrangement is in doubt, the device shall be
operated from its internal electrical power source.
• All signal input and output (I/O) connectors are intended for connection of only those devices complying
with IEC 60601-1, or other IEC standards (e.g., IEC 60950) as appropriate to the device. Connecting
additional devices to the device may increase chassis and/or patient leakage currents. To maintain operator
and patient safety, consideration should be given to the requirements of IEC 60601-1-1, and leakage currents
should be measured to confirm no electric shock hazard exists.
• To improve immunity to potential interfering electromagnetic signals, shielded cabling is recommended
when connecting the device to a network.
• To maintain operator and patient safety, equipment connected to the same network as the device must meet
the requirements of IEC 60950 or IEC 60601-1.
• To prevent electric shock due to unequal ground potentials that may exist between points of a distributed
network system or fault conditions in external network connected equipment, network cable shielding
(where used) must be connected to protective earth ground appropriate to the area where the device is used.
• The device has not been designed for use with high-frequency (H ) surgical equipment and does not
provide a protective means against hazards to the patient.
• The quality of the signal produced by the device may be adversely affected by the use of other medical
equipment, including but not limited to defibrillators and ultrasound machines.
• or proper operation and the safety of users or patients and bystanders, equipment and accessories must be
connected only as described in this manual. Do not connect a telephone line cable to the LAN connector.
• This device may contain a GSM/GPRS (cellular modem) or wireless LAN (WLAN) module for transmitting
ECG records. Device labeling and the presence of an antenna port will indicate if your device is equipped
with such a module. If so equipped, the following notices apply:
• The GSM/GPRS module operates in allocated frequency bands depending on the model.
Identification of the installed GSM/GPRS module can be found on a label on the bottom of the device.
• MultiTech Systems, Inc. Model MTSMC-G- 1 (Europe and elsewhere): 900/1800 MHz
• MultiTech Systems, Inc. Model MTSMC-G- 2 (U.S. and elsewhere): 850/1900 MHz
• MultiTech Systems, Inc. Model MTSMC-G- 4 (Quad Band): 850/900/1800/1900 MHz,
user selectable
• The WLAN identification can be found on a label on the bottom of the device.
• Quatech, Inc. Model WLNG-AN-DP101: 2400 MHz
User Safety Information (Continued)
v

User Safety Information (Continued)
• Use of the GSM/GPRS or WLAN module may interfere with other equipment operating in the vicinity.
Check with local authorities or spectrum management officials in your facility to determine if restrictions
apply to the use of this feature in your area.
• Do not transmit via the GSM/GPRS or WLAN module with a missing or damaged antenna. Replace a
damaged antenna immediately.
• Use only the antenna supplied for use with this device. Unauthorized antennas, modifications, or
attachments could damage the GSM module and may contravene local R emission regulations or
invalidate type approval.
• To ensure compliance with current regulations limiting both maximum R output power and human exposure
to radio frequency radiation, a separation distance of at least 20 cm must be maintained between the device's
antenna and the head and body of the user and any nearby persons at all times. To help prevent degradation
of R signal and to avoid excess R energy absorption, do not touch the antenna during data transmission.
• The GSM/GPRS and WLAN modules comply with applicable R safety standards including standards and
recommendations for the protection of public exposure to R electromagnetic energy that have been
established by governmental bodies and other qualified organizations, such as the following:
• ederal Communications Commission ( CC)
• Directives of the European Community
• Directorate General V in Matters of Radio requency Electromagnetic Energy
• To prevent possible damage to the keyboard, do not use sharp or hard objects to depress keys, only
use fingertips.
• Do not attempt to clean the device or patient cables by submersing into a liquid, autoclaving, or steam
cleaning as this may damage equipment or reduce its usable life. Wipe the exterior surfaces with a warm
water and mild detergent solution and then dry with a clean cloth. Use of unspecified cleaning/disinfecting
agents, failure to follow recommended procedures, or contact with unspecified materials could result in
increased risk of harm to users, patients and bystanders, or damage to the device.
• No user-serviceable parts inside. Screw removal by qualified service personnel only. Damaged or suspected
inoperative equipment must be immediately removed from use and must be checked/repaired by qualified
service personnel prior to continued use.
• The rechargeable internal battery is a sealed lead-acid type and it is totally maintenance free. If the
battery appears to become defective, refer to Mortara Instrument Service Department.
• Do not pull or stretch patient cables as this could result in mechanical and/or electrical failures. Patient
cables should be stored after forming them into a loose loop.
• No calibration or special equipments are needed for the proper operation or maintenance of the device.
• When necessary, dispose of the device, its components and accessories (e.g., batteries, cables, electrodes),
and/or packing materials in accordance with local regulations.
vi
Caution(s)

• Excessive patient movement could interfere with the operation of the device.
• Proper patient preparation is important to proper application of ECG electrodes and operation of the device.
• There is no known safety hazard if other equipment, such as pacemakers or other stimulators, is used
simultaneously with the device; however, disturbance to the signal may occur.
• If the ECG amplifier input is out of normal operating range, the display will indicate a lead fail for the
lead(s) where this condition is present and if the signal is being printed, the respective lead(s) will print
out as a square wave.
• As defined by IEC 60601-1 and IEC 60601-2-25, the device is classified as follows:
• Class I equipment or internally powered.
• Type C defibrillation-proof applied parts.
• Ordinary equipment.
• Equipment not suitable for use in the presence of a flammable anesthetic
mixture with air or with oxygen or nitrous oxide.
• Continuous operation.
NOTE: From a safety perspective, per IEC 60601-1 and derivative standards/norms, this device
is declared to be “Class I” and uses a three-prong inlet to ensure an earth connection is made
along with mains. The ground terminal on the mains inlet is the only protective earth point in
the device. Exposed metal accessible during normal operation is double insulated from mains.
Internal connections to earth ground are functional earth.
• This device is intended to be used in a hospital or doctor’s office setting, and should be used and stored
according to the environmental conditions specified below:
Operating temperature: +10° to +40° C (+50° to +104° )
Operating humidity: 10% to 95% RH, non-condensing
Storage temperature: -40° to +70° C (-40° to +158° )
Storage humidity: 10% to 95% RH, non-condensing
Atmospheric pressure: 500 hPa to 1060 hPa
• The device will automatically turn off (blank screen) if the batteries have been severely discharged and
the AC mains is disconnected from the device.
• After operating the device using battery power, always reconnect the power cord. This ensures that the
batteries will be automatically recharged for the next time you use the device. A light next to the on/off
switch will illuminate, indicating that the device is charging. This light will turn off when the battery
is fully charged.
• The device is UL classified:
WITH RESPECT TO ELECTRIC SHOCK,
FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE
WITH UL2601-1, IEC60601-1, CAN/CSA CC22.2 N . 601.1,
AND IEC60601-2-25
User Safety Information (Continued)
vii
Note(s)
5P35

User Safety Information (Continued)
Wireless Data Transmission
• The device can be equipped with an optional wireless data transmission module (WLAN or GSM/GPRS
mobile). Both these technologies use radios to transmit data to a Mortara receiving application. Due to
the nature of radio transmissions, it’s possible that, due to the characteristics of the environment where
the device is located, some other R sources may interfere with the transmission generated by the device.
Mortara Instrument has tested the coexistence of the device with other devices that can interfere such as
devices using WLAN, Bluetooth radio, and/or cell phones. Although the current technology allows a very
successful rate of transmission, it’s possible that in some rare occurrences, the system may not perform at its
best resulting in a “failed transmission.” When this occurs, patient data will not be erased from the device
nor stored in the receiving application, ensuring that partial or corrupted data are not made available to the
receiving station. If the failure mode persists the user should move to a position where the R signals may
propagate better and allow successful transmissions.
W AN Option
• Wireless options transmit at 2.4 GHz. Other nearby wireless devices may cause interference. If possible,
move or turn off other devices to minimize potential interference.
• The following table shows the channels allocated in different geographic areas in the world. Please consult
with your IT personnel in order to set the device on the proper channels.
viii
Specification Description
Technology IEEE 802.11 b/g DSSS, Wi i compliant
Frequency 2.400 – 2.4835 GHz (U.S./CAN/Japan/Europe)
2.471 – 2.497 GHz (Japan)
Channels U.S.A./CANADA: 11 channels (1-11)
Europe: 13 channels (1-13)
Japan: 14 channels (1-14)
rance: 4 channels (10-13)
RF Power +15dBm (typical) approx. 32 mW

• The following table lists the frequency allocated for each channel used by the WLAN option.
• In order to achieve the best transmission rate, it is necessary that the facility where the device is operated
can provide good area coverage. Please consult the IT personnel of the facility to verify the proper WLAN
availability in the area where the device will be used.
• R wave propagation may be blocked or reduced by the environment where the device is used. Most common
areas where this may occur are: shielded rooms, elevators, underground rooms. In all the above situations, it is
recommended to move the device to a proper location and verify with the IT personnel of the facility the areas
where the WLAN signals are available.
User Safety Information (Continued)
ix
Channel Center Frequency Frequency Spread
1 2412 MHz 2399.5 MHz - 2424.5 MHz
2 2417 MHz 2404.5 MHz - 2429.5 MHz
3 2422 MHz 2409.5 MHz - 2434.5 MHz
4 2427 MHz 2414.5 MHz - 2439.5 MHz
5 2432 MHz 2419.5 MHz - 2444.5 MHz
6 2437 MHz 2424.5 MHz - 2449.5 MHz
7 2442 MHz 2429.5 MHz - 2454.5 MHz
8 2447 MHz 2434.5 MHz - 2459.5 MHz
9 2452 MHz 2439.5 MHz - 2464.5 MHz
10 2457 MHz 2444.5 MHz - 2469.5 MHz
11 2462 MHz 2449.5 MHz - 2474.5 MHz
12 2467 MHz 2454.5 MHz - 2479.5 MHz
13 2472 MHz 2459.5 MHz - 2484.5 MHz
14 2484 MHz 2471.5 MHz – 2496.5 MHz

User Safety Information (Continued)
x

E UIPMENT SYMBOLS AND MARKINGS
xi
Symbol Delineation
Attention, consult accompanying documents
Alternating current
Protective earth
use
Telephone line (modem)
Network (LAN)
Defibrillator-proof type C applied part
Output/Transmit
Input
ON/O (power)
Stop (of action)

Equipment Symbols and Markings (Continued)
xii
Shift key (to enter uppercase text)
Space key
Enter key (accept data/return)
Initiate printing of 12-lead ECG
Initiate printing of continuous rhythm strip
Do not dispose as unsorted municipal waste. Per EC
Directive 2002/96, requires separate handling for waste
disposal according to national requirements
Antenna
Indicates compliance to applicable EEC directives

Precautions
• Turn off the device before inspecting or cleaning.
• Do not immerse the device in water.
• Do not use organic solvents, ammonia-based solutions, or abrasive cleaning agents which may
damage equipment surfaces.
Inspection
Inspect your equipment daily prior to operation. If you notice anything that requires repair, contact an
authorized service person to make the repairs.
• Verify that all cords and connectors are securely seated.
• Check the case and chassis for any visible damage.
• Inspect cords and connectors for any visible damage.
• Inspect keys and controls for proper function and appearance.
Cleaning Exterior Surfaces and Patient Cable
❶Remove cables and lead wires from device before cleaning.
❷or general cleaning of cables and lead wires, use a soft, lint-free cloth lightly moistened with a mild
soap and water solution. Wipe and air dry.
❸or disinfecting the cables and lead wires, wipe exterior with a soft, lint-free cloth using a solution
of Sodium Hypochlorite (10% household bleach and water solution) minimum 1:500 dilution
(minimum 100 ppm free chlorine) and maximum 1:10 dilution as recommended by the APIC
Guidelines for Selection and Use of Disinfectants.
❹Use caution with excess liquid as contact with metal parts may cause corrosion.
❺Do not immerse cable ends or lead wires; immersion can cause metal corrosion.
➏Do not use excessive drying techniques such as forced heat.
WARNING: Do not attempt to clean/disinfect the device or patient cables by submerging into
a liquid, autoclaving, or steam cleaning. Never expose cables to strong ultra-violet radiation.
Cleaning the Device
Disconnect the power source. Clean the exterior surface of the device with a damp, soft, lint-free cloth using a
solution of mild detergent diluted in water. After washing, thoroughly dry off the device with a clean, soft cloth
or paper towel.
GENERAL CARE
xiii

General Care (Continued)
Sterilization
EtO sterilization is not recommended but may be required for cables and lead wires. requent sterilization
will reduce the useful life of cables and lead wires. If required, sterilize with ethylene oxide gas (EtO) at a
maximum temperature of 50°C/122° . After EtO sterilization, follow the recommendations from the sterilizer
manufacturer for required aeration.
Cautions
Improper cleaning products and processes can damage the device, produce brittle lead wires and cables,
corrode the metal, and void the warranty. Use care and proper procedure whenever cleaning or maintaining
the device.
xiv

Electromagnetic compatibility with surrounding devices should be assessed when using the device.
An electronic device can either generate or receive electromagnetic interference. Testing for electromagnetic
compatibility (EMC) has been performed on the device according to the international standard for EMC
for medical devices (IEC 60601-1-2). This IEC standard has been adopted in Europe as the European
Norm (EN 60601-1-2).
The device should not be used adjacent to, or stacked on top of other equipment. If the device must be
used adjacent to or stacked on top of other equipment, verify that the device operates in an acceptable
manner in the configuration in which it will be used.
ixed, portable, and mobile radio frequency communications equipment can affect the performance of
medical equipment. See Table X-4 for recommended separation distances between the radio equipment
and the device.
The use of accessories and cables other than those specified below, may result in increased emissions or
decreased immunity of the device.
9293-032-50 ELI standard patient cable, 12-lead, banana - AHA
9293-032-51 ELI standard patient cable, 12-lead, banana - IEC
9293-033-50 ELI standard patient cable, 12-lead, snap - AHA
9293-033-51 ELI standard patient cable, 12-lead, snap - IEC
9281-002-50 Banana plug to snap lead wire, 4 mm, set of 10
3181-008 Power cord, hospital grade, 8' U.S.
3181-002 Power cord, hospital grade, 8' International
ELECTROMAGNETIC COMPATIBILITY (EMC)
xv

ELECTROMAGNETIC COMPATIBILITY (EMC) (Continued)
xvi
Table X-1 Guidance and Manufacturer’s Declaration: Electromagnetic Emissions
The equipment is intended for use in the electromagnetic environment specified in the table below. The
customer or the user of the equipment should ensure that it is used in such an environment.
Table X-2 Guidance and Manufacturer’s Declaration: Electromagnetic Immunity
The equipment is intended for use in the electromagnetic environment specified in the table below. The
customer or the user of the equipment should ensure that it is used in such an environment.
NOTE: UT is the AC Mains voltage prior to application of the test level.
Emissions Test Compliance Compliance evel Electromagnetic Environment: Guidance
Electrostatic +/- 6 kV contact +/- 6 kV contact loors should be wood, concrete, or ceramic tile.
discharge (ESD) +/- 8 kV air +/- 8 kV air If floors are covered with synthetic material, the
IEC 61000-4-2 relative humidity should be at least 30%.
Electrical fast +/- 2 kV for +/- 2 kV for Mains power quality should be that of a typical
transient/burst power supply lines power supply lines commercial or hospital environment.
IEC 61000-4-4 +/- 1 kV for +/- 1 kV for
input/output lines input/output lines
Surge +/- 1 kV differential +/- 1 kV differential Mains power quality should be that of a typical
IEC 61000-4-5 mode +/- 2 kV mode +/- 2 kV commercial or hospital environment.
common mode common mode
Voltage dips, short <5% UT <5% UT Mains power quality should be that of a typical
interruptions, and (>95% dip in UT) (>95% dip in UT) commercial or hospital environment.
voltage variations for 0.5 cycle for 0.5 cycle
on power supply 40% UT 40% UT
input lines (60% dip in UT) (60% dip in UT)
IEC 61000-4-11 for 5 cycles for 5 cycles
Power frequency 3 A/m 3 A/m Power frequency magnetic fields should be at levels
(50/60 Hz) characteristic of a typical location in a typical
magnetic field commercial or hospital environment.
Emissions Test Compliance Electromagnetic Environment: Guidance
RF Emissions CISPR 11 Group 1 The equipment uses R energy only for its internal function.
Therefore, its R emissions are very low and not likely to
cause any interference in nearby electronic equipment.
RF Emissions CISPR 11 Class A The equipment is suitable for use in all establishments other
than domestic and those directly connected to the public
low-voltage power supply network that supplies buildings
Harmonic Emissions Complies used for domestic purposes.
IEC 61000-3-2
Voltage Fluctuations/Flicker Complies
Emissions IEC 61000-3-3

Table X-3 Guidance and Manufacturer’s Declaration: Electromagnetic Immunity
The equipment is intended for use in the electromagnetic environment specified in the table below. The
customer or the user of the equipment should ensure that it is used in such an environment.
a. ield strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios,
amateur radios, AM and M radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To assess the
electromagnetic environment due to fixed R transmitters, an electromagnetic site survey should be considered. If the measured
field strength in the location in which the equipment is used exceeds the applicable R compliance level above, the equipment
should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such
as reorienting or relocating the equipment.
b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [3] V/m.
ELECTROMAGNETIC COMPATIBILITY (EMC) (Continued)
xvii
Emissions Test IEC 60601 Test evel Compliance evel Electromagnetic Environment: Guidance
Portable and mobile R communications
equipment should be used no closer to any
part of the equipment, including cables, than
the recommended separation distance
calculated from the equation applicable to
the frequency of the transmitter.
Recommended separation distance
Conducted RF 3 Vrms 150 kHz 3 Vrms 150 kHz
IEC 61000-4-6 to 80 MHz to 80 MHz
80 MHz to 800 MHz
Radiated RF 3 V/m 80 MHz 3 V/m 80 MHz
IEC 61000-4-3 to 2.5 GHz to 2.5 GHz
800 MHz to 2.5 GHz
Where Pis the maximum output power rating
of the transmitter in watts (W) according
to the transmitter manufacturer and dis
the recommended separation distance in
meters (m).
ield strengths from fixed R transmitters,
as determined by an electromagnetic site
surveya, should be less than the compliance
level in each frequency rangeb.
Interference may occur in the vicinity of
equipment marked with the following symbol:

Table X-4 Recommended Separation Distances Between Portable and Mobile RF
Communications Equipment and the Equipment
The equipment is intended for use in the electromagnetic environment in which radiated R disturbances are
controlled. The customer or the user of the equipment can help to prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile R communications equipment (transmitters)
and the equipment as recommended in the table below, according to the maximum output power of the
communications equipment.
or transmitters rated at a maximum output power not listed above, the recommended separation distance d
in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where Pis
the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1: At 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 the absorption and reflection from structures, objects, and people.
ELECTROMAGNETIC COMPATIBILITY (EMC) (Continued)
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Rated Maximum Output Separation Distance According to Frequency of Transmitter (m)
Power of Transmitter W
150 Hz to 800 MHz 800 MHz to 2.5 GHz
0.01 0.1 m 0.2 m
0.1 0.4 m 0.7 m
1 1.2 m 2.3 m
10 4.0 m 7.0 m
100 12.0 m 23.0 m