Hologic LOCalizer User manual

LOCalizer Reader and
RFID Localization System
Lector LOCalizer y sistema de localización RFID
Manual del usuario/Sujeto a prescripción médica
Lecteur LOCalizer et Système de localisation RFID
Manuel de l’utilisateur
LOCalizer Lesegerät und RFID Lokalisierungssystem
Bedienungsanleitung
De LOCalizer-reader en het RFID-lokalisatiesysteem
Gebruikershandleiding
Lettore LOCalizer e sistema di localizzazione RFID
Manuale d’uso
ES
FR
DE
NL
IT
EN
User Manual

User Manual 1
CAUTION:
Read all warnings, cautions, and instructions provided with this equipment before using.
Read the instructions, warnings, and cautions provided with the Tag Applicator and
LOCalizer Surgical Probe before using. Specific instructions pertaining to Tag implantation
and preparation and use of the Surgical Probe are not included in this Manual.
DESCRIPTION
RFID Localization System
The Tag Applicator, LOCalizer™ Reader, and LOCalizer Surgical Probe are components of the RFID
Localization System. The Tag is intended to be placed in breast tissue, within 6 cm of the breast
surface, using the Tag Applicator. The Tags, when used in conjunction with the LOCalizer Reader and
LOCalizer Surgical Probe, can be used as a guide for the surgeon to follow in the excision of tissue.
RFID Localization System (RFLS) components are listed below:
System Component Description Part Number
LOCalizer Reader RFID Reader HB100-EU
LOCalizer Surgical
Probe
Attachment probe for use with LOCalizer RFID
Reader HB110-EU
Tag Applicator Needle applicator with preloaded RFID Tag HB200-XX-EU*
HB300-XX-EU*
*XX indicates the length of the applicator needle in cm. Contact distributor for available sizes
in your area.
The LOCalizer Instrument Drape (HB120) is provided separately for use with the LOCalizer Reader
in a sterile environment.
LOCalizer Reader
The LOCalizer Reader locates and reads (RFID) Tags which have been implanted using the
Tag Applicator.
The LOCalizer Reader displays the distance between the Tag and the Probe under use.
Tag location is also indicated by an audible sound of which the pitch and volume increases in
proportion to a decrease in the “LOCalizer to Tag” distance.
The LOCalizerReader is a portable, battery-operated system and is supplied non-sterile.
The Tag Applicator and LOCalizer Surgical Probe are provided sterile.
This manual includes guidelines for the use of the Probe in the sterile field.
INDICATIONS FOR USE
The Tag of the RFLS is intended for percutaneous placement in the breast to mark ( >30 days) a lesion
intended for surgical removal. Using image guidance (such as ultrasound or radiography) or aided by
non-imaging guidance (RFLS), the RFID Tag is located and surgically removed with the target tissue.
The RFLS is intended only for the non-imaging detection and localization of the Tag that has been
implanted in a lesion intended for surgical removal.
EN

ALoop Probe (integrated)
BScreen and Control Panel
CBattery Cover
DSurgical Probe
ESurgical Probe Connector
2 User Manual
CONTRAINDICATIONS
The RFID Localization System is not intended for use under conditions where breast lesion localization
is contraindicated.
The RFID Localization System is not intended for use in the heart, eyes, brain or spinal cord.
The Tag should not be placed in a tissue site with clinical evidence of infection.
The Tag should not be placed in muscle tissue.
LOCALIZER READER OVERVIEW
The LOCalizer Reader (Figure 1) is composed of:
• 1 Handheld LOCalizer Reader
• 2 AA Alkaline batteries (IEC-LR6)
The LOCalizer Reader includes an integrated Loop Probe (A) that is used to locate and read Tags from
the skin surface. It can also be used with the LOCalizer Surgical Probe attachment (D) to locate and
read Tags within the surgical incision. Probe details are included in Table 1. Subsequent sections of
this manual describe in detail probe and LOCalizer Reader use.
FIGURE 1. LOCalizer Reader with Surgical Probe connected (Instrument Cover not shown)
Table 1. Probe Specifications
Probe Part No. Probe Dimensions Max Reading Depth
Loop Probe (integrated) n/a 12 mm inner diameter
39 mm outer diameter
6 cm*
Surgical Probe HB110 175 mm long
8 mm diameter
3 cm**
* As measured from center of the Loop probe to end of Tag (Figure 3)
** As measured from end of the Surgical probe to end of Tag (Figure 4)

User Manual 3
WARNINGS
General
The LOCalizer Reader is designed only for use with the LOCalizer Surgical Probe and Tags.
Tag Applicator and Surgical Probe
The Tag Applicator is intended for sterile use. Do NOT use this product on a non-sterile surface
prior to use internally.
Caution should be exercised with using the device on patients with prostheses so as to not puncture
the prosthesis during placement.
If any resistance is felt during advancement of the Surgical Probe or Tag Applicator (during
implantation), carefully correct the orientation but never apply strong forces in order to overcome the
obstacle.
Exercise caution when placing the Tag near the chest wall. Insert the Needle applicator parallel to the
chest wall so as to not puncture the chest wall during placement.
To avoid confusion between signals produced by both Tags, it is recommended that no more than one
Tag is implanted in the same operative breast.
Exercise caution during surgical excision of the lesion to avoid cutting or damaging the Tag. When
using electrosurgical tools, avoid direct contact with the Tag as thermal damage can result. If the Tag
is inadvertently damaged, ensure all parts of the Tag are retrieved from the surrounding tissue.
When using the Surgical Probe intraoperatively, avoid touching or moving the Tag with the Surgical
Probe.
Do NOT use the Tag Applicator or Surgical Probe if the package is open or damaged.
Use the Tag Applicator and Surgical Probe prior to the expiration date shown on the product label.
The Tag Applicator with Tag and Surgical Probe have been designed for SINGLE USE only. Reusing
this medical device bears the risk of cross-patient contamination. The residue of biologic material
can promote the contamination of the device with pyrogens or microorganisms which may lead to
infectious complications.
DO NOT RESTERILIZE. After sterilization, the sterility of the product is not guaranteed because of an
indeterminable degree of potential pyrogenic or microbial contamination which may lead to infectious
complications. Cleaning, reprocessing and/or re-sterilization of the present medical device increases
the probability that the device will malfunction due to potential adverse effects on components that
are influenced by thermal and/or mechanical changes.

4 User Manual
LOCalizer Reader
Do NOT use if the package or LOCalizer Reader is damaged.
The LOCalizer Reader is a non-sterile device. Drape with the sterile LOCalizer Instrument Cover
(Product HB120) when using in a sterile environment. Do NOT sterilize the LOCalizer Reader as
sterility cannot be guaranteed. Cleaning, reprocessing and sterilization of this LOCalizer Reader could
cause the LOCalizer Reader to malfunction due to adverse effects on components.
Use of the LOCalizer Reader adjacent to or stacked with other equipment should be avoided
because it could result in improper functioning. If such use is necessary, this equipment and the other
equipment should be observed to verify that they are operating normally.
Use of accessories, transducers and cables other than those specified or provided by Health Beacons
could result in increased electromagnetic emissions or decreased electromagnetic immunity of this
equipment and result in improper operation.
The LOCalizer Reader may suffer erroneous signal detection or degraded distance accuracy of an
RFID Tag due to electromagnetic interference from HF Surgical Equipment, other RFID readers, or
wireless charging devices.
Portable RF communications equipment such as cell phones or tablets should be used no closer than
30 cm (12 inches) to any part of the LOCalizer Reader to avoid degradation of the performance of this
equipment.
With the exception of battery replacement, no modification or repair of this equipment by the user is
allowed. If the LOCalizer Reader stops working or is damaged it should be replaced.
The user is responsible to maintain FCC compliance. Any changes, modifications, or use of non-
Health Beacons probes could void the user’s authority to operate the equipment.
PRECAUTIONS
General
Failure to thoroughly review and adhere to the information contained in this User Manual may pose a
potential hazard to the patient and/or user and may void the warranty.
This product should only be used by a physician who is completely familiar with the indications,
contraindications, limitations, typical findings and possible side effects of using a system for lesion
localization that employs a marker at the site of the lesion and a reader for marker retrieval.
Handle all components in a manner that will prevent accidental contamination.
Tag Applicator and Surgical Probe
Do NOT use the Tag Applicator if needle is bent and/or tip is damaged.
Do NOT use the Surgical Probe if it is damaged.
Do NOT remove Safety Lock from applicator until needle has been advanced to desired location for
Tag deployment.
Do NOT implant Tag greater than 6 cm deep from the breast surface to accommodate the LOCalizer
Reader detection range.
Ensure the Tag is completely deployed in the breast tissue by depressing the plunger until it contacts
the Applicator barrel.
After use, the Tag Applicator, Tag, and Surgical Probe are biohazards. Dispose in accordance with
your facility’s biohazardous waste procedures.
Do NOT immerse the Surgical Probe in liquid.

User Manual 5
LOCalizer Reader
The LOCalizer Reader is designed to locate the low frequency 134 kHz Health Beacons Tags.
Do NOT use the LOCalizer Reader with RFID markers other than the Health Beacons Tags. Other
markers may give some response but the detection range and accuracy may be affected. Most
markers at other frequencies will not be readable.
Metal Items, such as surgical tools, that block the path between the implanted Tag and LOCalizer
Probe may alter the LOCalizer Reader readings. Ensure these items are not in the path of the Tag
being read.
Ensure the LOCalizer Reader battery is fully charged prior to use. A back-up LOCalizer Reader is
recommended in the case of instrument malfunction or battery depletion.
Do NOT immerse LOCalizerReader in liquid.
The LOCalizer Reader is sensitive to electromagnetic interference during the operation of HF Surgical
Equipment such as Electrosurgery cutting tools and instruments, and should be used
non-concurrently with such equipment.
The LOCalizer Reader is a sensitive radio receiver operating at 134 kHz. Its operation may be affected
by other devices operating near this frequency.
The LOCalizer Reader is intended for use only in a hospital, except near active HF Surgical Equipment
and other RFID equipment or wireless battery chargers.
The LOCalizer transmits RF energy at 134 kHz and is sensitive to a receive bandwidth of 120kHz
to 150khz.
The LOCalizerReader transmits a weak unmodulated magnetic field at 134 kHz (<200 microwatts
ERP) to sense the presence of the Tag. Modulation of the field by the Tag is detected by the LOCalizer
Reader. Other devices that generate electromagnetic fields in this frequency region may interfere with
the ability of the LOCalizer to sense the location of the Tag. Interference may occur for example from
other RFID readers, inductive chargers commonly used for cell phones or other devices, or magnetic
induction proximity detectors. Sensitive devices such as other Low Frequency RFID readers may
likewise be affected by the operation of the LOCalizer Reader in the same vicinity.
ADVERSE REACTIONS
None known.
HOW SUPPLIED
The LOCalizer Reader with its integrated Loop Probe is provided nonsterile and is intended for reuse.
The Tag Applicator and LOCalizer Surgical Probe are provided sterile and are intended for single
use only. The Tag is non-pyrogenic. The RFLS is not made with natural rubber latex.

Distance to Tag
Active Probe Icon
Tag ID Number
Intensity Indicator
Unit Indicator
Battery Charge
Probe Toggle
Brightness
Volume
Power On/Off
#04987
6 User Manual
LOCALIZER READER CONTROLS
The LOCalizer Reader contains the display and controls for the System and are located on the
front face of the instrument. The LOCalizer Reader allows the user to adjust the system’s settings,
and produces signals in the form of a displayed distance in millimeters and an audible pitch that
represents the intensity of a Probe’s signal.
FIGURE 2. LOCalizer Reader Controls and Displays (described below)
Name Control/
Display Description
Power
Turns power ON/OFF.
To switch ON, press the power button. The system performs a
self-test before it is available for use.
To switch OFF, press the ON/OFF button.
Probe Toggle Toggles between the Loop Probe and Surgical Probe.
Display -
Distance
Output
Displays the distance to the Tag in millimeters.
Display -
Tag ID Displays the Tag ID.
Display -
Unit Indicator Displays the unit of measurement as millimeters (mm).

User Manual 7
Name Control/
Display Description
Volume
Adjustment Increases/decreases the volume of the audible signal.
Brightness
Adjustment Increases/decreases the brightness of the display.
Active
Probe Icon
Displays which Probe is currently active: Loop (left icon)
or Surgical Probe (right icon).
Battery
Indicator
Indicates current battery level.
The battery level decreases as the battery discharges.
The symbol flashes on and off when the battery needs
replacement. When the battery reaches a critical level, the
device is disabled.
Intensity
Indicator
Indicates intensity of the signal between the Probe and the Tag.
The Intensity Indicator can be used alternatively to the audio
tone to assess location.
Sound and Backlight
The selected sound and display light levels are stored when the instrument is turned off and recalled
when it is turned on again.
When the battery is critically low, the sound level is automatically lowered to extend operating lifetime.
TAG IMPLANTATION
Refer to the Tag Applicator Instructions for Use for details regarding Tag placement and removal
methods.

LOCalizer Reader (Loop)
Probe in line with Tag
Strongest response and most
accurate distance reading
LOCalizer Reader (Loop)
Probe perpendicular to Tag
Weakest or no response
Direction of decreasing response
8 User Manual
LOCALIZATION PROCEDURE
1. Power on the LOCalizer Reader.
The firmware version number is displayed.
There is a brief delay while the integrated loop probe is tested.
If the Surgical probe is installed, there is a corresponding delay while it is tested.
2. Use the up and down arrows on the brightness control to adjust the screen to the
desired intensity.
3. Check the battery charge indicator to ensure there is adequate charge. It is highly encouraged to
change the batteries before each procedure. Batteries can be replaced following directions in the
“CARE AND MAINTENANCE” section.
NOTE: The LOCalizer Reader may turn ON with a critically low battery, but will not continue
operation normally.
4. Use the Loop Probe on the LOCalizer Reader to identify the general location of the Tag from the
surface of the breast. The sound level and pitch increases as the LOCalizer Reader approaches
the Tag. The scale shows the approximate distance to the nearest point of the Tag in millimeters.
When using the Loop probe the range of the LOCalizer Reader is at least 60 mm.
FIGURE 3. Assessing Tag location/position with Loop Probe using signal strength (not to scale)
NOTE: The sound and distance display rise to a maximum when the Tag is in line with and directly
under the sensing head surface (Figure 3). Identification of the Tag location can be refined by
moving the Probe until both ends of the Tag are detected.
NOTE: The Tag’s unique identification number is displayed once the probe is close enough to the
implanted Tag.
5. Use the up and down arrows on the volume control to adjust the audio tone to the
desired volume.
6. If excising the Tag and lesion, plan and mark the surgical area with the approximate location
of the Tag.
7. In preparation for surgery, place the sterile LOCalizer Instrument Cover over the LOCalizer Reader
per the Instrument Cover Instructions for Use.
NOTE: The LOCalizer Reader can be used on an un-breached breast surface in a non-sterile
setting. In a sterile setting, use of the Instrument Cover is required. The Surgical Probe is only
intended for sterile use.

LOCalizer Surgical Probe
perpendicular to Tag
Weakest or no response Direction of decreasing response
LOCalizer Surgical Probe
parallel with Tag
Strongest response and most
accurate distance reading
User Manual 9
8. Connect the Surgical Probe into the receptacle on the LOCalizer Reader by introducing it through
the cover connector hole. When connected, the LOCalizer Reader automatically identifies the
Surgical Probe as the active probe, performs a self-test and the LOCalizer Reader screen displays
the Surgical Probe icon. When the Surgical Probe is attached, the range of LOCalizer Reader is at
least 30 mm.
FIGURE 4. Assessing Tag location/position with Surgical Probe using signal strength (not to scale)
NOTE: Readings will vary depending on the orientation of the Tag, because the signal emitted
is directional along the long axis of the Tag. The LOCalizer Reader will receive the strongest
response and most accurate distance reading when the Surgical Probe is parallel with the Tag.
Signal strength decreases as the Surgical Probe head moves toward perpendicular to the Tag and
the distance accuracy may decrease.
9. During the surgical approach, the LOCalizer Reader may be toggled between the Loop Probe
and Surgical Probe by depressing the probe toggle switch. The active probe is indicated
on the display.
10. Excise intended tissue with implanted Tag.
11. Confirm the Tag is present in the excised specimen using the LOCalizer Reader or imaging
(ultrasound or radiography).
TROUBLESHOOTING
Little or No Tag
Response
The Tag is out of LOCalizer Reader detection range.
Reposition the LOCalizer Loop or Surgical Probe until a signal is detected.
The Tag signal is receiving interference from another Tag or device.
Remove alternative source of signal or use alternate imaging guidance
such as ultrasound or radiography to confirm Tag location.
The Tag is broken.
An alternate imaging guidance such as ultrasound or radiography should
be used to ensure the entire Tag is removed with tissue removal.
Tag distance reading
is incorrect
Positioning of the Reader.
Resolution of system allows discrimination of two ends of Tag. Reposition
the LOCalizer Loop or Surgical Probe and look for readings from both ends
of Tag. Readings at these positions have the highest accuracy.
Tag presence is
indicated and
incorrect
Interference of transmitting equipment.
If a Tag detection is indicated when no Tag is within the normal detection
distance, check for other RFID readers, wireless chargers or other nearby
equipment that may be transmitting in the region of 134 kHz.

10 User Manual
Tag location cannot
be determined
Readings are difficult to interpret.
Resolution of system allows discrimination of two ends of Tag. Reposition
the LOCalizer Loop or Surgical Probe and look for readings from both ends
of Tag to determine Tag location.
The LOCalizer
Reader is
unresponsive
The LOCalizer Reader has a critically low battery.
Replace batteries.
If new batteries fail to work, the LOCalizer Reader may have suffered a
fatal error. Contact your supplier for replacement of the unit.
Tag ID is not
displayed or display
shows “#?????”
The Tag ID is displayed only when the Loop probe is within 40mm of the
Tag and the Surgical Probe is within 20mm. If within these limits, there may
be an interfering signal from another RFID reader, tag or wireless charger.
Check for and remove other RFID readers, tags, wireless chargers or other
nearby equipment that may be transmitting in the region of 134 kHz.
This condition may occur if multiple Tags were placed in the same
operative breast and the LOCalizer Reader can’t discern one Tag signal
from the other. Re-position the Reader in multiple locations to identify
more than one Identification number. Use the identification numbers to
determine each Tag’s placement.
Display shows:
“?” over Probe icon
The Selected Probe has low signal strength. System may continue to
function, the range accuracy for tag reading may be impacted. Check
environment for possible sources of interference and remove. This may
occur when Probe or Reader is placed on a metal surface; moving the
Probe or Reader away clears the “?”. Check the active probe icon to
ensure the correct probe is selected.
Display shows:
with Probe icon.
The Selected Probe does not pass self-test.
For the Surgical probe, replace the Probe.
For the Loop probe, replace the LOCalizer Reader.
Battery Icon Flashing Low battery.
The maximum audio volume is automatically reduced to extend remaining
operational time.
Replace Batteries.
Display shows: An Internal error has occurred.
This is generally a permanent fatal error, and the LOCalizer Reader must be
replaced. Before returning the LOCalizer Reader for service, try removing
and replacing the battery. This may clear an error.
TROUBLESHOOTING CONTINUED

User Manual 11
CARE AND MAINTENANCE
Surface Care
As needed, use a damp cloth or sponge, with mild detergent if necessary. Do NOT use abrasives
or solvents, as these may degrade the case. Do NOT submerge the LOCalizer Reader in liquid.
Batteries
Periodic battery replacement is necessary for the unit to continue to operate correctly. To replace
batteries, open the battery compartment by holding the textured edges and pulling firmly off the
device. Install commercially available AA batteries following the battery polarity symbols on the inside
of the case. Approximate battery life expectancy under normal use conditions is 8 hours. These times
may be slightly reduced at high display intensity and audio volume. Use only good quality AA Alkaline
cells (IEC-LR6).
REPLACEABLE / REPAIRABLE COMPONENTS
There are no repairable components. With the exception of battery replacement, (Refer to Care
and Maintenance) no modification or repair of this equipment by the user is allowed.
If the LOCalizer Reader stops working or is damaged it should be replaced.
TECHNICAL INFORMATION
Environmental, Storage, and Transportation Conditions
LOCalizer Reader
Operational Conditions Temporary Storage and
Transport Conditions*
Ambient Temperature 5˚ - 30˚C (41˚ - 86˚F)* -20° - 50°C (-4°-122°F)
Relative Humidity 30% - 75%, non-condensing 15% - 93%, non-condensing
Atmospheric Pressure 70 kPa – 102 kPag 50kPa - 106kPa
*For best service life of AA Alkaline Cells used in LOCalizer Reader, storage temperature should be
5°- 30°C. To avoid potential damage from cells leaking, remove battery if the LOCalizer Reader will
not be used within 2 months.
Store the Tag Applicator and Surgical Probe at ambient temperature 15° to 30°C (59° to 86°F).
Interference
This device complies with part 15 of the FCC Rules. Operation is subject to the following two
conditions:
1. This device may not cause harmful interference.
2. This device must accept any interference received, including interference that may cause
undesired operation.
The user is responsible to maintain FCC compliance. Any changes or modifications not expressly
approved by Health Beacons could void the user’s authority to operate the equipment.
Use the LOCalizer Reader only with a LOCalizer Surgical Probe and Tag.

12 User Manual
Electromagnetic Emissions and Immunity
This equipment has been tested and found to comply with the limits for a Class B digital device,
pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection
against harmful interference in a residential installation. This equipment generates, uses, and can
radiate radio frequency energy and, if not installed and used in accordance with the instructions, may
cause harmful interference to radio communications.
However, there is no guarantee that interference will not occur in a particular installation.
If this equipment does cause harmful interference to radio or television reception, which can be
determined by turning the equipment off and on, the user is encouraged to try to correct the
interference by one or more of the following measures:
• Reorient or relocate the receiving antenna.
• Increase the separation between the equipment and receiver.
• Consult the dealer or an experienced radio/TV technician for help.
The LOCalizer Reader is compliant to applicable emissions and immunity standards listed below.
Standards Description Security Level or Limit Criteria Test Result
IEC 60601-1-2:2014
Product Family
Standard Emissions
and Immunity
Medical electrical equipment -
Part 1-2: General requirements
for basic safety and essential
performance - Collateral
standard: Electromagnetic
compatibility - Requirements
and tests - Edition 4
The requirements for use in
the Professional healthcare
facility environment were
chosen by the manufacturer.
See called out basic stan-
dards below
See
Below
Complies
EN55011:2009
+A1:2010, FCC
15.109(a) & ICES-003
Radiated Emissions: At any
one voltage & frequency
(Per table 1)
Class B Group 1.
30MHz - 1 GHz
Limit Complies
EN55011:2009
+A1:2010, FCC
15.107(a) & ICES-003
Conducted Emissions: At
any one voltage & frequency
(Per table 1)
NA, NA.
EUT is battery operated only
Limit NA
EN61000-3-2:2006
+A1:2009+A2:2009
Power Harmonics: At 230 V,
50Hz or 60 Hz (Per table 1)
NA
EUT is battery operated only
Limit NA
EN61000-3-3:2013 Voltage Fluctuation: At 230
V, 50Hz (Per table 1)
NA
EUT is battery operated only
Limit NA
EN61000-4-2:2009
Basic test standard
Electrostatic Discharge
Immunity: At any one
voltage & frequency
(Per tables 1 and 7)
±15 kV Air Discharge
±8 kV Contact Discharge,
VCP, HCP
per
Annex I
Complies
EN61000-4-3:2006 +
A2:2010
Basic test standard
Radiated Electromagnetic
Fields Immunity: At any one
voltage & frequency
(Per tables 1 and 4)
3V/m, 80-2700 MHz at 80%
1kHz AM Modulation
per
Annex I
Complies
EN61000-4-3:2006 +
A2:2010
Basic test standard
Radiated Electromagnetic
and Proximity Fields
Immunity:
At any one voltage &
frequency (Per tables 4 and 9)
RF wireless communication
fields on Spot Frequencies
from Table 9 at 50%, Square
wave Modulation 9 to 28 V/w
per
Annex I
Complies
EN61000-4-4:2012
Basic test standard
Electrical Fast Transient/
Burst Immunity: 100kHz at
any one voltage & frequency
(Per table 1)
NA on AC or DC Mains
±1 kV SIP/SOP
EUT is battery operated only
per
Annex I
Complies
EN61000-4-5:2006
Basic test standard
Surge Immunity:
At any one voltage &
frequency (Per table 1)
NA CM Line-Gnd
NA, DM Line-Line
NA SIP/SOP Ports are not
connected directly to
outdoor cables
NA NA

STERILIZE
User Manual 13
Standards Description Security Level or Limit Criteria Test Result
EN61000-4-6:2009
Basic test standard
Conducted Immunity:
At any one voltage &
frequency (Per table 7)
3V rms, 0.15 - 80 MHz
6V rms, on ISM bands
on SIP/SOP port only
per
Annex I
Complies
EN61000-4-8:2010
Basic test standard
Power Frequency Magnetic
Field Immunity: At any one
voltage at 50 or 60 Hz
(Per table 1)
30A/m @ 50Hz or 60Hz
3 orthogonal orientations
per
Annex I
Complies
EN61000-4-11:2004
Basic test standard
Voltage Dips and Voltage
Interruptions: At min & max
rated input voltage at any
rated power frequency
(Per table 1)
NA EUT is battery operated
only
NA
NA
NA
NA NA
SYMBOLS
The following symbols may be found on the product labeling for the RFID Localization System:
Symbol Description
Use by Date
YYYY-MM-DD
Expiration date is
represented by the following:
YYYY represents the year
MM represents the month
DD represents the day
Manufacture Date
Manufacturer
Follow instructions for use
www.hologic.com/package-inserts
Do NOT use if package
is damaged
Do NOT resterilize
Single use only
U.S. Federal law restricts this
device to sale by or on the
order of a physician
Sterilized using Ethylene Oxide
(Tag Applicator)
Sterilized using irradiation
(Probe)
DISPOSAL OF EQUIPMENT
After following the cleaning recommendations above, and there are no biohazard risks involved,
dispose of the LOCalizer Reader at the end of the LOCalizer Reader’s useable life per Waste
of Electrical and Electronic Equipment (WEEE) directive [Directive 2002/96/EC]. Dispose of Tag
Applicator, Surgical Probe, and Instrument Cover per the device Instructions for Use.
Symbol Description
Catalog Number
Batch Code
Serial Number
Quantity
Caution
Device is non-sterile
Type B Equipment
Temperature limitation
Humidity limitation
Do NOT dispose of
the LOCalizer Reader
by placing into trash
receptacles.
Keep dry
Self test in process
Call for Service
QTY

14 Manual del usuario
PRECAUCIÓN:
Lea todas las advertencias, precauciones e instrucciones que se suministran con este
equipo antes de utilizarlo.
Lea las instrucciones, advertencias y precauciones que se suministran con el aplicador
de etiqueta y la sonda quirúrgica LOCalizer antes de utilizar estos productos. Las
instrucciones específicas relacionadas con la implantación, la preparación y el uso de la
sonda quirúrgica no se incluyen en este manual.
DESCRIPCIÓN
Sistema de localización RFID (identificación por radiofrecuencia)
El aplicador de etiqueta, el lector LOCalizer™ y la sonda quirúrgica LOCalizer son componentes del
sistema de localización RFID. La etiqueta está diseñada para colocarse en el tejido mamario, a 6 cm
de profundidad de la superficie del seno, mediante el aplicador de etiqueta. Las etiquetas, cuando se
utilizan en conjunto con el lector LOCalizer y la sonda quirúrgica LOCalizer, se pueden emplear como
una guía para que el cirujano realice la escisión del tejido.
A continuación, se detallan los componentes del sistema de localización RFID (RFLS, sistema de
ubicación por radiofrecuencia):
Componente del sistema Descripción Número de pieza
Lector LOCalizer Lector RFID HB100-EU
Sonda quirúrgica
LOCalizer
Sonda de conexión para utilizar con el lector
RFID LOCalizer HB110-EU
Aplicador de etiqueta Aplicador de aguja con etiqueta RFID
precargada
HB200-XX-EU*
HB300-XX-EU*
* XX indica la longitud del aplicador de aguja en centímetros. Comuníquese con el distribuidor para
información sobre los tamaños disponibles en su zona.
La cubierta de instrumentos LOCalizer (HB120) se proporciona por separado para utilizar con el lector
LOCalizer en un ambiente estéril.
Lector LOCalizer
El lector “LOCalizer ubica y lee (RFID) las etiquetas que se han implantado por medio del aplicador
de etiqueta. El lector “LOCalizer muestra la distancia entre la etiqueta y la sonda que se está
utilizando.
La ubicación de la etiqueta también se indica mediante un sonido audible cuyo tono y volumen
aumentan a medida que disminuye la distancia entre “LOCalizer y la etiqueta”.
El lector “LOCalizer es un sistema portátil a pilas y se proporciona de forma no estéril. El aplicador
de etiqueta y la sonda quirúrgica “LOCalizer se suministran estériles. Este manual incluye las pautas
para el uso de la sonda en un ambiente estéril.
INDICACIONES DE USO
La etiqueta del sistema RFLS está diseñada para su colocación percutánea en el seno con el fin de
marcar (>30 días) una lesión que se pretende extirpar quirúrgicamente. La etiqueta RFID se coloca y
extirpa quirúrgicamente con el tejido afectado a través de una técnica de detección por imagen (p. ej.,
ecografía o radiografía) o una técnica de detección sin imagen (RFLS).
RFLS tiene como único objetivo la detección y ubicación sin imagen de la etiqueta que se ha
implantado en una lesión que se pretende extirpar de forma quirúrgica.
ES

ASonda en bucle (integrada)
BPantalla y panel de control
CCubierta de las pilas
DSonda quirúrgica
EConector de la sonda quirúrgica
Lector LOCalizer y sistema de localización RFID 15
CONTRAINDICACIONES
El sistema de localización RFID no está diseñado para usarse en condiciones en que la ubicación de
la lesión mamaria está contraindicada.
El sistema de localización RFID no está diseñado para usarse en el corazón, los ojos, el cerebro o la
médula espinal.
La etiqueta no se debe colocar en un lugar del tejido donde haya signos clínicos de infección.
La etiqueta no se debe colocar en tejidos musculares.
DESCRIPCIÓN GENERAL DEL LECTOR LOCALIZER
El lector LOCalizer (Figura 1) cuenta con los siguientes componentes:
• lector portátil LOCalizer
• pilas alcalinas AA (IEC-LR6)
El lector LOCalizer incluye una sonda en bucle integrada (A) que se utiliza para ubicar y leer
etiquetas desde la superficie de la piel. También se puede emplear con la conexión de la sonda
quirúrgica LOCalizer (D) para ubicar y leer etiquetas dentro de una incisión quirúrgica. La Tabla 1
incluye los detalles de la sonda. Las siguientes secciones de este manual describen en detalle el
uso de la sonda y del lector LOCalizer.
FIGURA 1. Lector LOCalizer con sonda quirúrgica conectada (No se muestra la cubierta de instrumentos)
Tabla 1. Especiicaciones de la sonda
Sonda N.º de
pieza Dimensiones de la sonda Profundidad máxima de lectura
Sonda en bucle
(integrada) N/C Diámetro interno: 12 mm Diámetro externo: 39 mm
6 cm*
Sonda quirúrgica HB110 Longitud: 175 mm
Diámetro: 8 mm
3 cm**
* Medición desde el centro de la sonda en bucle hasta el extremo de la etiqueta (Figura 3)
** Medición desde el extremo de la sonda quirúrgica hasta el extremo de la etiqueta (Figura 4)

16 Manual del usuario
ADVERTENCIAS
Advertencias generales
El lector LOCalizer está diseñado solo para usarse con la sonda quirúrgica y las etiquetas LOCalizer.
Aplicador de etiqueta y sonda quirúrgica
El aplicador de etiqueta se debe utilizar en condiciones estériles. NO utilice este producto en una
superficie no estéril antes del uso interno.
Se debe tener precaución al utilizar el dispositivo en pacientes con prótesis para no perforar la
prótesis durante la colocación.
Si se percibe resistencia durante el avance de la sonda quirúrgica o del aplicador de etiqueta (durante
la implantación), corrija cuidadosamente la orientación pero nunca aplique una fuerza importante para
superar el obstáculo.
Tenga cuidado al colocar la etiqueta cerca de la pared torácica. Inserte el aplicador de aguja de forma
paralela a la pared torácica para no perforar la pared torácica durante la colocación.
Para evitar confusiones entre las señales emitidas por dos etiquetas, se recomienda que no se
implante más de una etiqueta en el mismo seno que se someterá a cirugía.
Tenga precaución durante la escisión quirúrgica de la lesión para evitar cortar o dañar la etiqueta.
Cuando utilice instrumental electroquirúrgico, evite el contacto directo con la etiqueta ya que puede
provocar daños térmicos. Si la etiqueta se daña inadvertidamente, asegúrese de que todas las partes
de la etiqueta se recuperen del tejido circundante.
Cuando se utiliza la sonda quirúrgica de forma intraoperatoria, evite tocar o mover la etiqueta con la
sonda quirúrgica. NO utilice el aplicador de etiqueta o la sonda quirúrgica si el envase está abierto o
dañado.
Utilice el aplicador de etiqueta y la sonda quirúrgica antes de la fecha de vencimiento que se muestra
en la etiqueta del producto.
El aplicador de etiqueta con la etiqueta y la sonda quirúrgica se han diseñado para un ÚNICO
USO. La reutilización de este dispositivo médico conlleva el riesgo de contaminación cruzada entre
pacientes. El residuo de material biológico puede promover la contaminación del dispositivo con
pirógenos o microorganismos que pueden provocar complicaciones infecciosas.
NO VUELVA A ESTERILIZAR. Después de la esterilización, la esterilidad del producto no está
garantizada debido a un grado indeterminable de posible contaminación pirógena o microbiana
que puede provocar complicaciones infecciosas. La limpieza, el reprocesamiento o la esterilización
repetida del presente dispositivo médico aumenta la probabilidad de que el dispositivo funcione mal
debido a los posibles efectos adversos sobre los componentes que están influenciados por cambios
térmicos o mecánicos.

Lector LOCalizer y sistema de localización RFID 17
Lector LOCalizer
NO utilice el producto si el envase o el lector LOCalizerestán dañados.
El lector LOCalizeres un dispositivo no estéril. Utilice la cubierta de instrumentos LOCalizer(producto
HB120) estéril para cubrirlo cuando trabaja en un ambiente estéril. NO esterilice el lector LOCalizer ya
que no es posible garantizar la esterilidad. La limpieza, el reprocesamiento y la esterilización del lector
LOCalizer podrían hacer que el lector LOCalizer funcione mal debido a efectos adversos sobre los
componentes.
Se debe evitar el uso del lector LOCalizer en proximidad directa con otros equipos o apilado con
otros equipos, ya que podría provocar un funcionamiento incorrecto. Si tal uso es necesario, se
deben controlar ambos equipos con el fin de verificar que estén funcionando normalmente.
El uso de accesorios, transductores y cables que no sean los especificados o provistos por Health
Beacons podría provocar un aumento de las emisiones electromagnéticas o una disminución de la
inmunidad electromagnética de este equipo y provocar un funcionamiento incorrecto.
El lector LOCalizer puede sufrir una detección de señal errónea o una precisión de distancia
distorsionada de una etiqueta RFID debido a la interferencia electromagnética de equipos médicos de
alta frecuencia, otros lectores RFID o dispositivos de carga inalámbrica.
Los equipos portátiles de comunicación por radiofrecuencia, como teléfonos celulares o tabletas,
se deben utilizar a una distancia no inferior a los 30 cm (12 pulgadas) de cualquier parte del lector
LOCalizer a fin de evitar la degradación del rendimiento de este equipo.
Salvo el reemplazo de las pilas, no se permite ninguna modificación o reparación de este equipo por
parte del usuario. Si el lector LOCalizer deja de funcionar o está dañado, se debe reemplazar.
El usuario es responsable de mantener el cumplimiento de las normas de FCC. Cualquier cambio,
modificación o uso de sondas que no son de Health Beacons podría anular la autorización otorgada
al usuario para operar el equipo.
PRECAUCIONES
Precauciones generales
Si no se revisa a fondo y no se cumple la información contenida en este Manual del usuario, es
posible que se genere un posible riesgo para el paciente o el usuario, y esto puede anular la garantía.
Este producto solo debe utilizarloun médico que esté completamente familiarizado con las
indicaciones, contraindicaciones, limitaciones, hallazgos típicos y posibles efectos secundarios del
uso de un sistema de localización de lesiones que emplea un marcador en el lugar de la lesión y un
lector para recuperar marcadores.
Manipule todos los componentes de una manera que evite la contaminación accidental.
Aplicador de etiqueta y sonda quirúrgica
NO utilice el aplicador de etiqueta si la aguja está doblada o la punta está dañada. NO utilice la sonda
quirúrgica si está dañada.
NO retire el dispositivo de seguridad del aplicador hasta que la aguja haya avanzado al lugar deseado
para la implantación de la etiqueta.
El rango de detección del lector LOCalizer alcanza una profundidad máxima de 6 cm desde la
superficie del seno; por lo tanto, NO implante la etiqueta a una profundidad mayor.
Asegúrese de que la etiqueta esté completamente implantada en el tejido mamario pulsando el
émbolo hasta que entre en contacto con el cilindro del aplicador.
Después del uso, el aplicador de etiqueta, la etiqueta y la sonda quirúrgica son riesgos biológicos.
Deséchelos de acuerdo con los procedimientos de eliminación segura de desechos biológicos de su
establecimiento.
NO sumerja la sonda quirúrgica en líquido.

18 Manual del usuario
Lector LOCalizer
El lector LOCalizer está diseñado para ubicar las etiquetas Health Beacons a baja frecuencia (134
kHz). NO utilice el lector LOCalizer con marcadores RFID que no sean las etiquetas Health Beacons.
Otros marcadores pueden arrojar alguna respuesta, pero el rango de detección y la precisión pueden
verse afectados. La mayoría de los marcadores en otras frecuencias no serán legibles.
Los elementos metálicos (p. ej., el instrumental quirúrgico) que bloquean la ruta entre la etiqueta
implantada y la sonda LOCalizer pueden alterar las lecturas del lector LOCalizer. Asegúrese de que
estos elementos no estén en la ruta de la etiqueta que está leyendo.
Asegúrese de que las pilas del lector LOCalizer estén completamente cargadas antes de su uso. Se
recomienda tener un lector LOCalizer de respaldo en caso de mal funcionamiento del instrumento o
agotamiento de las pilas.
NO sumerja el lector LOCalizer en líquido.
El lector LOCalizer es sensible a las interferencias electromagnéticas durante el funcionamiento
de los equipos quirúrgicos de alta frecuencia, como las herramientas e instrumentos de corte de
electrocirugía, y no debe utilizarse de forma simultánea con dichos equipos.
El lector LOCalizer es un radiorreceptor sensible que opera a 134 kHz. Su funcionamiento puede
verse afectado por otros dispositivos que operan cerca de esta frecuencia.
El lector LOCalizer está diseñado para su uso solo en un hospital, pero no cerca de equipos
quirúrgicos de alta frecuencia que estén activos y otros equipos RFID o cargadores de pila
inalámbricos.
El lector LOCalizer transmite energía de radiofrecuencia a 134 kHz y es sensible a un ancho de banda
de recepción de 120 kHz-150 kHz.
El lector LOCalizer transmite un campo magnético no modulado débil a 134 kHz (<200 microvatios
de PRA) para detectar la presencia de la etiqueta. El lector LOCalizer detecta la modulación de
campo de la etiqueta. Otros dispositivos que generan campos electromagnéticos en esta región
de frecuencia pueden interferir con la capacidad del lector LOCalizer de detectar la ubicación de la
etiqueta. Puede producirse interferencia, por ejemplo, a partir de otros lectores RFID, cargadores
inductivos comúnmente utilizados para teléfonos celulares u otros dispositivos, o detectores de
proximidad por inducción magnética. Los dispositivos sensibles, como otros lectores RFID de baja
frecuencia, también pueden verse afectados por el funcionamiento del lector LOCalizer en la
misma zona.
REACCIONES ADVERSAS
No se conocen.
PRESENTACIÓN
El lector LOCalizer con la sonda en bucle integrada se proporciona en forma no estéril y está
diseñado para reutilizarse. El aplicador de etiqueta y la sonda quirúrgica LOCalizer se proporcionan
esterilizados y están diseñados para un único uso. La etiqueta es apirógena. RFLS no está fabricado
con látex de goma natura