Hillrom Welch Allyn UTK User manual

Welch Allyn
®
Diagnostic Cardiology
Suite Wireless Acquisition
Module™and UTK™
User Manual

© 2019 Welch Allyn. All rights are reserved. To support the intended use of the product described in this publication, the
purchaser of the product is permitted to copy this publication, for internal distribution only, from the media provided by
Welch Allyn. No other use, reproduction, or distribution of this publication, or any part of it, is permitted with out written
permission from Welch Allyn. Welch Allyn assumes no responsibility for any injury to anyone, or for any illegal or improper
use of the product, that may result from failure to use this product in accordance with the instructions, cautions, warnings,
or statement of intended use published in this manual.
CAUTION Federal law restricts this device to sale by or on the order of a
physician.
This document contains confidential information that belongs to Welch Allyn. No part of this document may be transmitted,
reproduced, used, or disclosed outside of the receiving organization without the express written consent of Welch Allyn.
Welch Allyn is a registered trademark of Welch Allyn. AM12 ,WAM, are trademarks of Welch Allyn Microsoft and Windows
are registered trademarks of Microsoft Corporation. Adobe and Acrobat are registered trademarks of Adobe Systems
Incorporated. DICOM is the registered trademark of the National Electrical Manufacturers Association for its standards
publications relating to digital communications of medical information. Citrix and Citrix XenApp are registered trademarks
of Citrix Systems, Inc. Software: V2.1.0 2019
Welch Allyn is a registered trademark of Welch Allyn.
For information about any Welch Allyn product, visit: https://www.welchallyn.com/en/about-us/locations.html
For patent information, please visit www.welchallyn.com/patents
Customer Service and Technical Support: https://www.welchallyn.com/en/other/contact-us.html
1.888.667.8272, [email protected]
This manual applies to the 901128 CARDIOPULMONARY ECG SYSTEM and 901095 ECG ACQUISITION MODULE
9515-174-60-ENG Rev B
Revision date: 2019-07
EU IMPORTER
Welch Allyn, Inc.
4341 State Street Road
Skaneateles Falls, NY 13153 USA
welchallyn.com
Welch Allyn Limited
Navan Business Park, Dublin Road,
Navan, Co. Meath C15 AW22
Ireland

i
TABLE OF CONTENTS
NOTICES................................................................................................................................................................. 1
MANUFACTURER’S RESPONSIBILITY ....................................................................................................................................1
RESPONSIBILITY OF THE CUSTOMER ....................................................................................................................................1
EQUIPMENT IDENTIFICATION.............................................................................................................................................1
COPYRIGHT AND TRADEMARK NOTICES...............................................................................................................................1
OTHER IMPORTANT INFORMATION.....................................................................................................................................1
WARRANTY INFORMATION ...................................................................................................................................3
YOUR WELCH ALLYN WARRANTY.......................................................................................................................................3
USER SAFETY INFORMATION .................................................................................................................................5
WARNING(S) ..............................................................................................................................................................5
CAUTION(S)...................................................................................................................................................................7
NOTES..........................................................................................................................................................................8
EQUIPMENT SYMBOLS AND MARKINGS ................................................................................................................ 9
DOCUMENTATION SYMBOLS .............................................................................................................................................9
MISCELLANEOUS SYMBOLS ...............................................................................................................................................9
GENERAL CARE .................................................................................................................................................... 11
PRECAUTIONS ..............................................................................................................................................................11
INSPECTION .................................................................................................................................................................11
CLEANING AND DISINFECTION .........................................................................................................................................11
STERILIZATION..............................................................................................................................................................11
CAUTIONS ...................................................................................................................................................................11
ELECTROMAGNETIC COMPATIBILITY (EMC) ......................................................................................................... 13
GUIDANCE AND MANUFACTURER’S DECLARATION:ELECTROMAGNETIC EMISSIONS ..................................................................14
GUIDANCE AND MANUFACTURER’S DECLARATION:ELECTROMAGNETIC IMMUNITY...................................................................14
GUIDANCE AND MANUFACTURER’S DECLARATION:ELECTROMAGNETIC IMMUNITY...................................................................15
RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT AND THE EQUIPMENT
.................................................................................................................................................................................16
REGULATORY RADIO COMPLIANCE ...................................................................................................................................17
INTRODUCTION ................................................................................................................................................... 23
MANUAL PURPOSE .......................................................................................................................................................23
AUDIENCE ...................................................................................................................................................................23
INDICATIONS FOR USE ...................................................................................................................................................23
SYSTEM DESCRIPTION....................................................................................................................................................23
WELCH ALLYN WIRELESS ACQUISITION MODULE WITH LEAD WIRES.......................................................................................24
APPROVED BATTERY MODELS .........................................................................................................................................25
USB TRANSCEIVER KEY (UTK) ........................................................................................................................................25
PAIRING THE WIRELESS ACQUISITION MODULE WITH THE WELCH ALLYN DIAGNOSTIC CARDIOLOGY SUITE ....................................25
BATTERY INSTALLATION .................................................................................................................................................26
APPLYING POWER.........................................................................................................................................................26
ATTACHING THE LEAD WIRE CONNECTOR BLOCK ................................................................................................................26
LABELING THE WELCH ALLYN WIRELESS ACQUISITION MODULE AND UTK...............................................................................26

TABLE OF CONTENTS
ii
LEAD FAIL ...................................................................................................................................................................27
LED INDICATORS ..........................................................................................................................................................27
MAINTENANCE .................................................................................................................................................... 29
CLEANING AND DISINFECTING THE WELCH ALLYN WIRELESS ACQUISITION MODULE..................................................................29
DISPOSAL OF WASTE MATERIALS.....................................................................................................................................29
APPENDIX ............................................................................................................................................................ 31
PART NUMBERS ...........................................................................................................................................................31
WELCH ALLYN WIRELESS ACQUISITION MODULE SPECIFICATIONS..........................................................................................32
UTK SPECIFICATIONS ....................................................................................................................................................33
SERIAL AND PART NUMBER LOCATION ..............................................................................................................................33

1
NOTICES
Manufacturer’s Responsibility
Welch Allyn 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 Welch Allyn.
•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. Failure to do so may cause undue failure and possible health hazards.
Equipment Identification
Welch Allyn 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 Welch Allyn.
Other Important Information
The information in this document is subject to change without notice.
Welch Allyn 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. Welch Allyn assumes no
responsibility for any errors or omissions that may appear in this document. Welch Allyn makes no
commitment to update or to keep current the information contained in this document.

NOTICES
2

3
WARRANTY INFORMATION
Your Welch Allyn Warranty
WELCH ALLYN, INC. (hereafter referred to as “Welch Allyn”) warrants that components within Welch
Allyn products (hereafter referred to as “Product/s”) will be free from defects in workmanship and
materials for the number of years specified on documentation accompanying the product, or previously
agreed to by the purchaser and Welch Allyn, or if not otherwise noted, for a period of twelve (12) months
from the date of shipment.
Consumable, disposable or single use products such as, but not limited to, PAPER or ELECTRODES are
warranted to be free from defects in workmanship and materials for a period of 90 days from the date of
shipment or the date of first use, whichever is sooner.
Reusable product such as, but not limited to, BATTERIES, BLOOD PRESSURE CUFFS, BLOOD
PRESSURE HOSES, TRANSDUCER CABLES, Y-CABLES, PATIENT CABLES, LEAD WIRES,
MAGNETIC STORAGE MEDIUMS, CARRY CASES or MOUNTS, are warranted to be free from defects
in workmanship and materials for a period of 90 days. This warranty does not apply to damage to the
Product/s caused by any or all of the following circumstances or conditions:
a) Freight damage;
b) Parts and/or accessories of the Product/s not obtained from or approved by Welch Allyn;
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 Welch Allyn;
f) Other events outside of Welch Allyn’s reasonable control or not arising under normal operating
conditions.
THE REMEDY UNDER THIS WARRANTY IS LIMITED TO THE REPAIR OR REPLACEMENT WITHOUT
CHARGE FOR LABOR OR MATERIALS, OR ANY PRODUCT/S FOUND UPON EXAMINATION BY
WELCH ALLYN TO HAVE BEEN DEFECTIVE. This remedy shall be conditioned upon receipt of notice by
Welch Allyn of any alleged defects promptly after discovery thereof within the warranty period. Welch
Allyn’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 Welch Allyn’s
principal place or any other place as specifically designated by Welch Allyn or an authorized distributor or
representative of Welch Allyn, and (ii) all risk of loss in transit. It is expressly agreed that the liability of
Welch Allyn is limited and that Welch Allyn does not function as an insurer. A purchaser of a Product/s, by
its acceptance and purchase thereof, acknowledges and agrees that Welch Allyn is not liable for loss, harm,
or damage due directly or indirectly to an occurrence or consequence therefrom relating to the Product/s.
If Welch Allyn should be found liable to anyone under any theory (except the expressed warranty set forth
herein) for loss, harm, or damage, the liability of Welch Allyn shall be limited to the lesser of the actual loss,
harm, or damage, or the original purchase price of the Product/s when sold.

WARRANTY INFORMATION
4
EXCEPT AS SET FORTH HEREIN WITH RESPECT TO REIMBURSEMENT OF LABOR CHARGES, A
PURCHASER’S SOLE EXCLUSIVE REMEDY AGAINST WELCH ALLYN FOR CLAIMS RELATING TO
THE PRODUCT/S FOR ANY AND ALL LOSSES AND DAMAGES RESULTING FROM ANY CAUSE
SHALL BE THE REPAIR OR REPLACEMENT OF DEFECTIVE PRODUCT/S TO THE EXTENT THAT
THE DEFECT IS NOTICED AND WELCH ALLYN IS NOTIFIED WITHIN THE WARRANTY PERIOD. IN
NO EVENT, INCLUDING THE CLAIM FOR NEGLIGENCE, SHALL WELCH ALLYN BE LIABLE FOR
INCIDENTAL, SPECIAL, OR CONSEQUENTIAL DAMAGES, OR FOR ANY OTHER LOSS, DAMAGE, OR
EXPENSE OF ANY KIND, INCLUDING LOSS OF PROFITS, WHETHER UNDER TORT, NEGLIGENCE
OR STRICT LIABILITY THEORIES OF LAW, OR OTHERWISE. THIS WARRANTY IS EXPRESSLY IN
LIEU OF ANY OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO THE
IMPLIED WARRANTY OF MERCHANTABILITY AND THE WARRANTY OF FITNESS FOR A
PARTICULAR PURPOSE.

5
USER SAFETY INFORMATION
WARNING:
Means there is the possibility of personal injury to you or others.
Caution:
Means there is the possibility of damage to the device.
Note:
Provides information to further assist in the use of the device.
WARNING(S)
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 transmits data reflecting a patient’s physiological condition to a properly equipped receiving
device 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. Contact service
for additional training options.

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 Welch
Allyn.
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 CF applied
parts, including the neutral conductor of the patient cable and electrodes, 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.
Defibrillation protection is guaranteed only if the original patient cable is used. Any modification of
this device may alter defibrillator protection.

USER SAFETY INFORMATION
6
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.
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.
●FCC Warning (Part 15.21): Changes or modifications not expressly approved by the party
responsible for compliance could void the user’s authority to operate the device.

A possible explosion hazard exists. Do not use the device in the presence of a flammable anesthetic
mixture.
The device has not been designed for use with high-frequency (HF) 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.
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.
Operations may be affected in the presence of strong electromagnetic sources such as
electrosurgery equipment.
The battery-operated device transmits data reflecting a patient’s physiological condition to a receiving
device. During operation failure, data transmission and LCD information will cease to occur. In
mission critical conditions, it is advisable to have a backup device available.
Use only recommended alkaline battery cells. Use of other cells may present a risk of fire or
explosion.
Low battery warning function is designed for alkaline battery cells only. Use of other cells may result
in failure of the low battery warning possibly resulting in a malfunction of the device.
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. 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. Do not sterilize the device or patient cables with Ethylene Oxide (EtO) gas. Refer to
Maintenance for proper cleaning and disinfection instructions.

USER SAFETY INFORMATION
7
Caution(s)

To prevent possible damage to the device, do not use sharp or hard objects to depress buttons, only
use fingertips.

The device and lead wires should be cleaned between each use. Inspect connections for damage or
excessive wear prior to each use. Replace lead wires if damage or excessive wear is noted.

Do not pull or stretch patient cables as this could result in mechanical and/or electrical failures. Lead
wires should be stored after forming them into a loose loop.
The device will only work with receiving devices that are equipped with the appropriate option.
No user-serviceable parts are inside. Damaged or suspected inoperative equipment must be
immediately removed from use and must be checked/repaired by qualified service personnel prior to
continued use.
This device is not recommended for use in the presence of imaging equipment such as Magnetic
Resonance Imaging (MRI) and Computed Tomography (CT) devices, etc.
The following equipment may cause interference with the RF channel: microwave ovens, diathermy
units with LANs (spread spectrum), amateur radios, and government radar.
When necessary, dispose of the device, its components and accessories (e.g., batteries, cables,
electrodes), and/or packing materials in accordance with local regulations.
AA batteries are known to leak their contents when stored in unused equipment. Remove battery
from device when not used for an extended period of time.
Be careful to insert the connector block into the appropriate input connector by matching the lead wire labels to
the device label.
To prevent possible damage to the device during transport and storage (while in original packaging)
the following environmental conditions must be adhered to (for ECG accessories, such as
electrodes, refer to applicable packaging) :
Ambient Temperature Range: -20°C to 65°C (-4°F to 149°F)
Relative Humidity Range: 5% to 95% (non-condensing)
Atmosphere Pressure: 500 hPa to 1060 hPa
●This device is intended to be used in a hospital or doctor’s office setting, and should be used according to the
environmental conditions specified below:
Ambient Temperature Range: 0°C to 40°C (32°F to 104°F)
Relative Humidity Range: 5% to 95% (non-condensing)
Atmosphere Pressure: 500 hPa to 1060 hPa

USER SAFETY INFORMATION
8
Notes
Proper patient preparation is important to proper application of ECG electrodes and operation of the
device.
If electrode is not properly connected to the patient, or one or more of the patient cable lead wires is
damaged, display will indicate a lead fault for the lead(s) where the condition is present.
For additional instructions and warnings, refer to the user manual of the receiving device.
As defined by IEC 60601-1 and IEC 60601-2-25, the device is classified as follows:
Class I equipment or internally powered.
Type CF (ECG) defibrillation-proof applied parts.
Equipment not suitable for use in the presence of a flammable anesthetic mixture.
Continuous operation.
The device will automatically start flashing LEDs if the battery has been discharged below 1.0 volts.
During normal operation, the green LED will display continuously.
If the battery cover is opened during transmission, the device will stop transmitting. The battery must
be reinserted and the cover must be applied to resume operation.
The device will automatically turn off (LEDs off) after two minutes of inactivity or user input. The
device will turn off immediately if the device battery has been severely discharged.
When pairing with the device, ensure the AM12 has been disconnected or the pairing operation will
fail.
A square wave presentation on the display while using the Welch Allyn Wireless Acquisition Module
may be due to the device being turned off, having no battery, not being paired correctly, operating out
of range, or due to a calibration error. Review the LED indicator and auditory advisory on the device
to ensure the unit is turned on, has proper battery level, is paired correctly, and is within
recommended proximity of the UTK, or power cycle the Welch Allyn Wireless Acquisition Module to
re-calibrate. See section on equipment preparation below for details.
The Wireless Acquisition Module is UL classified:
WITH RESPECT TO ELECTRIC SHOCK, FIRE AND MECHANICAL
HAZARDS ONLY IN ACCORDANCE WITH: ANSI/AAMI ES60601-1,
CAN/CSA-C22.2 No. 60601-1, IEC 60601-1, IEC 60601-2-25

9
EQUIPMENT SYMBOLS AND MARKINGS
Documentation Symbols
WARNING The warning statements in this manual identify conditions or practices
that could lead to illness, injury, or death. In addition, when used on a patient
applied part, this symbol indicates defibrillation protection is in the cables. Warning
symbols will appear with a grey background in a black and white document.
CAUTION The caution statements in this manual identify conditions or practices
that could result in damage to the equipment or other property, or loss of data.
Miscellaneous symbols
Defibrillator-proof type CF applied part
Acquire 12 Lead ECG
Acquire Rhythm Print
On / Off button
Battery with notification: See operating instructions for type of cell to
be used.
Do not dispose as unsorted municipal waste. Requires separate
handling for waste disposal according to local requirements.
Medical Device
Meets essential requirements of the European Medical Device
Directive 93/42/EC
Reorder Number
Model Identifier
Follow instructions/directions for use (DFU) -- mandatory action. A
copy of the DFU is available on this website. A printed copy of the

EQUIPMENT SYMBOLS AND MARKINGS
10
DFU can be ordered from Welch Allyn for delivery within 7 calendar
days.
Non-Ionizing Electromagnetic Radiation
Australian Communications and Media Authority (ACMA) Radio
Compliance Mark (RCM).

11
GENERAL CARE
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 cables and connectors are securely seated.
Check the case for any visible damage.
Inspect cables and connectors for any visible damage.
Inspect buttons and controls for proper function and appearance.
Cleaning and Disinfection
Refer Maintenance for proper cleaning and disinfection procedures.
Sterilization
Do not sterilize the device or patient cables with Ethylene Oxide (EtO) gas.
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.

GENERAL CARE
12

13
ELECTROMAGNETIC COMPATIBILITY (EMC)
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.
Fixed, 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, transducers, and cables other than those specified by Welch Allyn may result in
increased emissions or decreased immunity of the equipment.

ELECTROMAGNETIC COMPATIBILITY (EMC)
14
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.
Emissions Test
Compliance
Electromagnetic Environment: Guidance
RF Emissions
CISPR 11
Group 2
The equipment must emit electromagnetic energy in order to
perform its intended function. Nearby electronic equipment may
be affected.
RF Emissions
CISPR 11
Class B
The equipment 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
Not Applicable
Voltage Fluctuations/
Flicker Emissions
IEC 61000-3-3
Not Applicable
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.
Immunity Test
Compliance
Compliance Level
Electromagnetic Environment: Guidance
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
Not Applicable
Surge
IEC 61000-4-5
+/- 1 kV differential
mode
+/- 2 kV common
mode
Not Applicable
Voltage dips,
short
interruptions,
and voltage
variations on
power supply
input lines
IEC 61000-4-11
<5% UT
(>95% dip in UT)
for 0.5 cycle
40% UT
(60% dip in UT)
for 5 cycles
Not Applicable
Power frequency
(50/60 Hz)
magnetic field
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.
NOTE: UT is the AC Mains voltage prior to application of the test level.

ELECTROMAGNETIC COMPATIBILITY (EMC)
15
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.
Emissions Test
IEC 60601 Test
Level
Compliance
Level
Electromagnetic Environment: Guidance
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz to
80 MHz
3 Vrms
150 kHz to
80 MHz
Portable and mobile RF 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
P
Vrms
d





35.3
P
mV
d





/3 5.3
80 MHz to 800 MHz
P
mV
d





/3 7
800 MHz to 2.5 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 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:
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to
2.5 GHz
3 V/m
80 MHz to
2.5 GHz
a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land
mobile radios, amateur radios, 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 equipment is used
exceeds the applicable RF 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)
16
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 RF 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 RF communications
equipment (transmitters) and the equipment as recommended in the table 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 (m)
150 KHz to 800 MHz
800 MHz to 2.5 GHz
Pd 2.1
Pd 3.2
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
For 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.