Cianna Medical SCOUT Check User manual

SCOUT® Check Console
Operation Manual

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SCOUT Check Operation Manual 220-0011-B (2017-11)
Copyrights and Trademarks
©2017 Cianna Medical, Inc. All rights reserved. Patents pending.
Cianna Medical and SAVI SCOUT are registered trademarks of Cianna Medical, Inc.
Manufactured for:
Cianna Medical, Inc.
6 Journey, Suite 125
Aliso Viejo, CA 92656 USA
Tel: [phone]
URL: www.ciannamedical.com

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SCOUT Check Operation Manual 220-0011-B (2017-11)
TABLE OF CONTENTS
Table of Contents
INTRODUCTION ...................................................................................................................................... 4
Device Description .................................................................................................................................... 4
Indications for Use .................................................................................................................................... 4
Contraindications...................................................................................................................................... 4
Compatible Components .......................................................................................................................... 5
WARNINGS AND CAUTIONS ................................................................................................................... 6
CONTROLS, INDICATORS AND RECEPTACLES ......................................................................................... 8
Instrument Description............................................................................................................................. 8
CONSOLE SETUP AND OPERATION......................................................................................................... 9
Setting up the Console.............................................................................................................................. 9
Operating the Console ............................................................................................................................ 10
After Surgery........................................................................................................................................... 10
CLEANING .............................................................................................................................................11
TROUBLESHOOTING ............................................................................................................................. 12
MAINTENANCE AND SERVICE............................................................................................................... 13
SYMBOLS ..............................................................................................................................................14
SPECIFICATIONS.................................................................................................................................... 15
EMC Statement.....................................................................................................................................16
Electromagnetic Compliance (EMC) Tables ............................................................................................ 17

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SCOUT Check Operation Manual 220-0011-B (2017-11)
INTRODUCTION
Caution
Read all warnings, cautions, and instructions provided with this Console before using.
Read the instructions, warnings, and cautions provided with the SCOUT Check Handpiece and SAVI
SCOUT Reflector before using. Specific instructions are not included in this manual.
Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.
Device Description
The SCOUT® Check Console and SCOUT Check Handpiece, are accessories to the SAVI SCOUT System.
The SCOUT Check Console is a medical device that provides control operations for detecting the
presence of the SAVI SCOUT Reflector within breast tissue. The SCOUT Check Handpiece and SAVI
SCOUT Reflector are available separately.
The SCOUT® Check System employs micro-impulse radar and infrared light (IR) technology to detect the
presence of the Reflector, which is placed into the breast during a prior procedure. The Console
provides the micro-impulse radar signal to the Handpiece along with power for the infrared light
sources. The SCOUT Check Handpiece delivers the micro-impulse radar signal and infrared light into the
breast tissue and in turn receives signals reflected back from the Reflector. The Console processes the
reflected radar signals to provide the physician with an audible indication when the Reflector is
detected. The Console provides a maximum detection range of 60mm from the Handpiece to the
Reflector. The Console and Handpiece (available separately) are provided non-sterile. The Reflector
(available separately) is provided sterile.
Indications for Use
SCOUT Check
The SCOUT Check system is an accessory to the SAVI SCOUT System. The SAVI SCOUT is intended to be
used to confirm the functionality of the SAVI SCOUT Reflector subsequent to percutaneous placement in
Radiology.
SAVI SCOUT
The SAVI SCOUT Reflector is intended to be placed percutaneously in breast tissue to mark (>30 days) a
biopsy site or a lumpectomy site intended for surgical removal. Using imaging guidance (such as
ultrasound, MRI, or radiography) or aided by non-imaging guidance (SAVI SCOUT System) the SAVI
SCOUT Reflector is located and surgically removed with the target tissue. The SAVI SCOUT System is
intended only for the non-imaging detection and localization of the SAVI SCOUT Reflector that has been
implanted in a breast biopsy site or a lumpectomy site intended for surgical removal.
Contraindications
Not for detecting reflector location in muscle tissue.
The SCOUT Check System is intended only for use in confirming the functionality of the SAVI
SCOUT Reflector in breast tissue. The SCOUT Check System is contraindicated for use in ocular,
cardiac, neurological and spinal clinical applications.
Not intended for use in operating room environment.

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SCOUT Check Operation Manual 220-0011-B (2017-11)
Compatible Components
The following items are required for the proper use of the SCOUT Check Console. Use of other parts and
materials not listed below is contraindicated.
SAVI SCOUT Reflector
SCOUT Check Handpiece

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SCOUT Check Operation Manual 220-0011-B (2017-11)
WARNINGS AND CAUTIONS
It is important that the instructions supplied with this Console be read, understood, and followed.
Warnings
Failure to thoroughly review and adhere to the information contained in this Operation Manual
may pose a potential hazard to the patient and/or user.
Electric Shock Hazard –The Console must be properly grounded to ensure patient safety. Do not
connect the included power cord to extension cords or to power plug adapters. To avoid the risk of
electrical shock, this equipment must only be connected to supply mains with protective earth.
Electric Shock Hazard –No modification of this equipment is allowed. Do not remove the cover.
Removal of the cover may cause electrical shock. Contact Cianna Medical for service.
Electric Shock Hazard –Do not connect wet accessories to the Console.
Electric Shock Hazard –Always turn off and unplug the Console before cleaning.
Fire Hazard –Do not use extension cords.
Explosion Hazard –This system is not designed for use in an explosive atmosphere.
Never use any power adapter or cable other than the one specifically supplied with the instrument.
Check the instrument before use for signs of damage, particularly to cables. If the instrument is
damaged or gives unexpected performance or operation, then cease using the device and
ensure that it is serviced before recommencing use of the device.
If the patient has an internal or external active cardiac implant, contact the cardiac implant
manufacturer for instructions before using the SCOUT system. The micro-impulse radar signal may
interfere with the intended function of the cardiac implant.
Cautions
Read all warnings, cautions, and instructions provided with this Console before using.
Read the instructions, warnings, and cautions provided with the Handpiece and Reflector before
using. Specific instructions are not included in this manual.
Federal law restricts this device to sale by or on the order of a physician.
This equipment should only be used by a physician trained in its indicated use, limitations, and
possible complications of breast surgery techniques.
Inspect cords for breaks, cracks, nicks, or other damage before every use. If damaged, do not use.
Failure to observe this precaution may result in injury or electrical shock to the patient or operator.
Verify power cord is secure before each use.
Always switch the instrument off at the mains power outlet, before inserting or removing the
power connector from the rear of the instrument. Failure to do so may damage the internal
instrument electronics.
Do not leave the Console in Detection Mode when not in use.
Connect the power cord to a hospital grade wall outlet having the correct voltage or product
damage may result.
Ensure cables are positioned to prevent trip hazards.
For best results, operate the instrument in a stable (vibration-free) environment, with the Console
placed on a level working surface.
Do not operate Console within 10 meters of another Console.
Do not place Console in contact with other electrical equipment during use.
The Console is non-sterile. Do not sterilize.
Care should be taken not to drop the Console, or subject it to any form of rough physical handling,

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SCOUT Check Operation Manual 220-0011-B (2017-11)
either during normal use or during storage and transportation.
Never clean the Console using an excessively wet cloth, or by washing it under running water.
Do not clean the Console with abrasive cleaning or disinfectant compounds, solvents, or other
materials that could scratch the panels or damage the unit.
The Console, Handpiece, and the Delivery System of the SCOUT Check System are MR Unsafe and
should not be used in the MR environment
The implanted SAVI SCOUT Reflector is MR Conditional.
The use of Xenon light sources should be used with caution. Xenon light sources may contain
wavelengths of light that could affect the sensitivity of the system when the light is illuminating the
area of the reflector.

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SCOUT Check Operation Manual 220-0011-B (2017-11)
CONTROLS, INDICATORS AND RECEPTACLES
Instrument Description
The Console contains the controls. The controls are located on the front and back of the Console. The
Console produces a signal output in the form of an audible tone that represent the presence of the
Reflector.
Front Panel
Rear Panel
Start/Stop
Button
Handpiece
receptacle
connector
POWER LED
SYSTEM READY
LED
DETECT MODE
LED
Power on/off
switch
Power cord
receptacle
Fuse Drawer

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SCOUT Check Operation Manual 220-0011-B (2017-11)
CONSOLE SETUP AND OPERATION
Caution
Read all warnings, cautions, and instructions provided with this Console before using.
Read the instructions, warnings, and cautions provided with the Handpiece and Reflector before
using.
IMPORTANT
The SCOUT Check Console is intended for use by suitably qualified, trained and authorized physicians
and/or operating room staff. Cianna Medical Inc. takes no responsibility for the possible misuse or use
by inadequately qualified staff.
Setting up the Console
Warning
To avoid risk of electric shock, this equipment must only be connected to a supply mains with
protective earth.
Electric Shock Hazard –Do not connect wet Handpiece cables to the Console.
Fire Hazard –Do not use extension cords.
1. Verify the Console is off by pressing the power switch off ( O ).
2. Place the Console on a stable flat surface.
3. Plug the Console power cord into the rear panel receptacle.
4. Insert the power cord into a grounded power outlet.
5. Install the Handpiece as follows:
oThe white dot on the handpiece should be toward the top of the connector
oAlign the Handpiece with the Handpiece receptacle on the console
oPush the Handpiece into the receptacle until fully seated.
NOTE: User must be able to hear the audible feedback provided by the Console for proper operation.
Ensure the speaker grill on the rear of Console is clear of obstruction. Ensure that front panel is visible.

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SCOUT Check Operation Manual 220-0011-B (2017-11)
Operating the Console
6. Turn on the Console by pressing the power switch on ( | ). Verify the following:
oThe POWER LED lights up to indicate that the Power is on.
oAfter several seconds, the SYSTEM READY LED should light up.
7. Activate the Handpiece by pressing the START/STOP button on the front panel of the Console.
Verify that the DETECT MODE LED lights up, indicating that the Console is ready to operate.
8. Perform a Handpiece test by placing the distal end of the Handpiece near the self-test card.
oIf the test is successful, an audible indication sounds.
oIf the test is not successful, an audible indication does not sound. See ‘Troubleshooting’
section of this manual for appropriate steps.
9. Apply the Handpiece tip to skin. Ensure that no air gaps are present between the Handpiece tip
and skin.
oWhen the Handpiece detects the Reflector, the Console will emit a steady audible tone.
NOTE: When not in use, place the Console in Standby mode by pressing the Start/Stop button. The
SYSTEM READY LED will light. To return to DETECT MODE, perform Step 7 again.
After Surgery
10. Turn off the Console by pressing the power switch off ( O ).
11. Clean and disinfect the SAVI SCOUT Handpiece per the cleaning procedure provided with the
handpiece.
12. Unplug the power cord from the wall outlet.

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SCOUT Check Operation Manual 220-0011-B (2017-11)
CLEANING
Warning
Electric Shock Hazard –Always turn off and unplug the Console before cleaning.
Notice
Do not clean the Console with abrasive cleaning or disinfectant compounds, solvents, or other
materials that could scratch the panels or damage the console.
1. Turn off the Console, and unplug the power cord from the wall outlet.
2. Thoroughly wipe all surfaces of the Console, including handpiece receptacles, and power cord
with a mild cleaning solution or disinfectant and a damp cloth.
Follow universal, generally accepted practices when handling components that have come in contact
with blood or tissue.
Follow the procedures approved by your institution or use a validated infection control procedure. Do
not allow fluids to enter the Console. The Console cannot be sterilized.

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SCOUT Check Operation Manual 220-0011-B (2017-11)
TROUBLESHOOTING
General Troubleshooting Guidelines
If the Console malfunctions, check for conditions that may have caused the problem:
Check the Console for visible signs of physical damage.
Verify that the power cord is connected to the Console and power outlet.
Verify that the Handpiece cable is connected and attached properly.
Use the table below to help identify and correct specific conditions.
Situation
Recommendation
POWER LED does not
illuminate
Verify that AC power cord is connected.
Verify that the AC power outlet is live.
Replace power cord.
Replace power fuse (replace with a 1A FA type fuse).
SYSTEM READY light does
not illuminate steady
Verify that the Handpiece is connected and attached properly.
Turn the Console off, then on again.
Replace Handpiece.
If symptom persists, the Console may require service. Contact
Cianna Medical.
No sound heard from
Console
Verify that the console is in DETECT MODE.
Verify that the Handpiece is connected and attached properly.
Turn the Console off, then on again.
Replace Handpiece.
Use self-test card to check for system function.
If symptom persists, the Console may require service. Contact
Cianna Medical.
DETECT MODE light does
not illuminate
Press START/STOP button.
Turn the Console off, then on again.
If symptom persists, the Console may require service. Contact
Cianna Medical.
Tone during nonuse of
handpiece
Press START/STOP button, put system in SYSTEM READY.
Move handpiece away from other cables, devices.
Turn the Console off, then on again.

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SCOUT Check Operation Manual 220-0011-B (2017-11)
MAINTENANCE AND SERVICE
The SCOUT Check Console must be serviced by Cianna Medical Inc. To ensure proper performance, the
Console should be checked for any signs of damage or wear before each use and storage. This includes
the housing, integrity of switches, and power cord. Should abnormalities be discovered by the user, the
user should contact Cianna Medical, Inc. Do not use a damaged Console.
Preventative maintenance is limited to external cleaning of console, fuse replacement, and confirmation
of power up functional diagnostics as described in this manual. The SCOUT Check console does not
require any specific routine service.
The Console contains no user serviceable parts and should not be opened by the user. Please contact
Cianna Medical for service.
Cianna Medical Inc.
6 Journey, Suite 125
Aliso Viejo, CA 92656
USA
Phone: [phone]
www.ciannamedical.com
Caution
If a Console is to be shipped from your institution for repair, then please clean and disinfect the
Console as described in this manual before packing for shipment. Indicate on the outside of the
shipping container that the Console has been cleaned and disinfected.

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SCOUT Check Operation Manual 220-0011-B (2017-11)
SYMBOLS
The following are descriptions for the symbols shown on the rear panel of the Console.
Symbol
Description
Manufacturer of the device
Serial number
Catalog Number
Warning: risk of electric shock. No user serviceable parts inside.
General warning
See instructions for use
Identifies a type BF applied part

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SCOUT Check Operation Manual 220-0011-B (2017-11)
SPECIFICATIONS
Parameter
Specification
Operating power
AC Line Power 110/220 VAC (50/60Hz)
Power consumption
26 watts, nominal
38 watts, maximum (at high volume)
Audio volume
70 dB Sound Pressure Level at 1 meter
Sound indicator
Fixed tone.
Visual Indicators
LEDs
Instrument make / model
Cianna Medical Inc. / SCOUT Check Console
Dimensions
12 inches width
6 inches height
12 inches depth
Weight
6 lbs.
Operating ambient temperature range
10°C to 30°C (50° to 86° F)
Operating relative humidity range
30% to 75%, non-condensing
Storage ambient temperature range
-20oto 60oC (-40oto 104oF)
Storage relative humidity range
10 percent to 95 percent relative humidity, non-
condensing
Shipping temperature:
-40°C to 60°C (-40°F to 140°F) for 3 consecutive days.
Shipping humidity:
10% to 95% RH, non-condensing, for 3 consecutive
days.
Storage and transit atmospheric pressure
500hPa to 1060 hPa (7.3 psia to 15.4 psia)
Operating altitude
Maximum of 2000m
System Controls
Buttons
Interconnects
Custom cables
Ingress of Fluids
Not protected against the ingress of fluid. IPX0
Flammability
Equipment not suitable for use in the presence of
flammable anesthetic mixture with air or with oxygen
or with nitrous oxide
Electrical Conformity
This medical equipment has passed all required testing
for electric shock, fire and mechanical hazards in
accordance with UL60601-1, IEC/EN 60601-1
Electrical shock protection - Classification
Class I
Electrical shock protection - Degree
Type BF Equipment
Product Life
The Console is a non-sterile, durable good. The
product warranty is for a one-year time period
consistent with use described in this manual.
Applied Part
The Handpiece is the patient applied part
Separation from power mains
Power switch on rear panel provides full separation
from power mains

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SCOUT Check Operation Manual 220-0011-B (2017-11)
EMC Statement
Important information regarding Electromagnetic Compatibility (EMC)
With the increased number of electronic devices such as PC’s and mobile (cellular) telephones, medical
devices in use may be susceptible to electromagnetic interference from other devices. Electromagnetic
interference may result in incorrect operation of the medical device and create a potentially unsafe
situation.
Medical devices should also not interfere with other devices.
In order to regulate the requirements for EMC (Electro Magnetic Compatibility) with the aim to prevent
unsafe product situations, the IEC 60601-1-2 standard has been implemented. This standard defines the
levels of immunity to electromagnetic interferences as well as maximum levels of electromagnetic
emissions for medical devices.
The SCOUT Check System conforms to this IEC60601-1-2:2001 standard for both immunity and
emissions.
Nevertheless, special precautions need to be observed:
The use of accessories and cables other than those specified by Cianna Medical, may result in
increased emission or decreased immunity of the device.
The medical devices should not be used adjacent to or stacked with other equipment. In case
adjacent or stacked use is necessary, the medical device should be observed to verify normal
operation in the configuration in which it will be used.
Refer to further guidance below regarding the EMC environment in which the device should be used.

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SCOUT Check Operation Manual 220-0011-B (2017-11)
Electromagnetic Compliance (EMC) Tables
Guidance and manufacturer's declaration - electromagnetic emissions
The SCOUT Check System is intended for use in the electromagnetic environment specified below.
The customer or user of the SCOUT Check System should assure that it is used in such an
environment.
Emissions test
Compliance
Electromagnetic environment -
guidance
RF emissions
CISPR 11
Group 1
The SCOUT Check System uses very
lowpowerRF energy for its
function. Therefore, its RF
emissions are very low and are not
likely to cause any interference in
nearby electronic equipment.
RF emissions
CISPR11
Class A
The SCOUT Check System is
suitable for use in all
establishments other than
domestic, and may be used in
domestic establishments and
those directly connected to the
public low-voltage power supply
network that supplies buildings
used for domestic purposes,
provided the following warning
is heeded:
WARNING: This
equipment/system is intended
for use by healthcare
professionals only. This
equipment/system may cause
radio interference or may
disrupt operation of nearby
equipment. It may be necessary
to take mitigation measures,
such as re-orienting or
relocating the SCOUT Check
system or shielding the location.
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations/flicker
emissions
IEC 61000-3-2
Complies

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SCOUT Check Operation Manual 220-0011-B (2017-11)
Guidance and manufacturer's declaration - electromagnetic immunity
The SCOUT Check System is intended for use in the electromagnetic environment specified below. The
customer or the user of the SCOUT Check System should assure that it is used in such an environment.
Immunity Test
IEC 60601 Test Level
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
±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
IEC61000-4-5
±1 kV line(s) to line(s)
±2 kV 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
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
70%UT
(30 % dip in UT)
for 25 cycles
<5 % UT
(>95 % dip in
UT) for 5 sec
<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 5 sec
Mains power quality should be
that of a typical commercial or
hospital environment. If the
user of the SCOUT Check
System requires continued
operation during power mains
interruptions, it is required
that the SCOUT Check System
be powered from an
uninterruptible power supply
or a battery.
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
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 a.c. mains voltage prior to application of the test level.

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SCOUT Check Operation Manual 220-0011-B (2017-11)
Guidance and manufacturer's declaration - electromagnetic immunity
The SCOUT Check System is intended for use in the electromagnetic environment specified below. The
customer or the user of the SCOUT Check System should assure that it is used in such an environment.
*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.
Immunity Test
IEC 60601 Test
Level
Compliance
Level
Electromagnetic environment - guidance
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz to 80 MHz
3 V*
Portable and mobile RF communication
equipment should be used no closer to any part of
the SCOUT Check System, including cables, than
the recommended separation distance calculated
from the equation applicable to the frequency of
the transmitter.
Recommended separation distance 𝑑 = 1.2√𝑃
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to 2.5 GHz
3 V/m*
Recommended separation distance
𝑑 = 1.2√𝑃80 MHz to 800 MHz
𝑑 = 2.3√𝑃800 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 strength from fixed RF transmitters as
determined by an electromagnetic site survey (a)
should be less than the compliance level in each
frequency range (b)
Interference may occur in the vicinity of
equipment marked with the following symbol.
NOTE 1: At 80MHz and 800MHz, 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.
(a) 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 SCOUT Check System is used exceeds the applicable RF compliance level above,
the SCOUT Check System should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessarily, such as reorienting or relocating the SCOUT Check
System.
(b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m*.

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SCOUT Check Operation Manual 220-0011-B (2017-11)
Recommended separation distances between portable and mobile RF communications equipment
and the SCOUT Check System
The SCOUT CheckSystem is intended for use in the electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the SCOUT Check System can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the SCOUT Check System as recommended below,
according to the maximum output power of the communications equipment.
Rated maximum
output power of
transmitter
Watts (W)
Separation distance according to frequency of transmitter in meters (m)
150 kHz to 80 MHz
𝑑 = 1.2√𝑃
80 MHz to 800 MHz
𝑑 = 1.2√𝑃
800 MHz to 2.5 GHz
𝑑 = 2.3√𝑃
0.01
0.12
0.12
0.23
0.1
0.38
0.38
0.73
1
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
For transmitters rated at a maximum output power not listed above, the recommended separation
distance din 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 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.