Motiva Flora Manual

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Motiva Flora®Port Locator
Directions for Use

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DIRECTIONS FOR USE MOTIVA FLORA®PORT LOCATOR
Establishment Labs S.A.
CAUTION:
• Only health professionals with qualied training and licensed by the corresponding
national boards should use it. The use of this product by unqualied practitioners may
result in inferior aesthetic outcomes and serious adverse health effects.
• Federal (USA) law restricts the sale of this device to licensed healthcare practitioners.
INTRODUCTION
This document provides an overview of essential information about the Motiva Flora®Port
Locator, including the device description, indications for use, contraindications, warnings,
precautions, relevant topics, returned goods policy, and warranty.
RELEVANT TOPICS THAT MUST BE DISCUSSED WITH THE PATIENT
Doctors and health professionals must thoroughly read and understand this document’s
contents and ensure that all patient questions or concerns have been resolved prior to
using the device.
INTENDED USE /INDICATIONS FOR USE
The Motiva Flora® Port Locator (Figure 1) interacts exclusively with
the Motiva Flora® Tissue Expander product family to easily locate the
breast tissue expander’s integrated port and enable accurate injection
lling.
WARNING: Please read the user manual (this document) carefully
before using the device. Failing to read the instructions can cause
adverse situations for the patient.
INTENDED PATIENTS
Motiva Flora® Port Locator is intended to be used in patients who
require a staged tissue expander-based breast reconstruction with
Motiva Flora® Tissue Expander product family.
Figure 1: Motiva Flora® Port Locator

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PRECAUTIONS
The Motiva Flora®Port Locator should only be used as indicated in this document.
• Before use, read the instructions for use carefully.
• Failure to follow the safety instructions may damage the device and/or cause an injury
to the patient.
• Check Motiva Flora® Port Locator for damage before use.
• DO NOT expose the device to extreme temperatures (below -20 °C or above 39°C),
direct sunlight, or extreme humidity (80% or above).
• Hospitals and medical clinics are suitable environments to use the Motiva Flora®Port
Locator, except for areas near high electromagnetic (EM) disturbances, other active
radiofrequency (RF) devices, or RF shielded rooms.
• Portable RF communication equipment (including peripherals such as antenna, cables,
and external antennas) should not be used closer than 1 meter (39 inches) to any part
of the Motiva Flora® Port Locator, including cables specied by the manufacturer.
Otherwise, degradation of the performance of this equipment could result.
• The emission characteristics of this equipment make it suitable for use in industrial areas
and hospitals; if it is used in a residential environment, this equipment might not offer
adequate protection to radio-frequency communication services. The user might need
to take mitigation measures, such as relocating or re-orienting the equipment.
• DO NOT modify the device in any way.
• DO NOT use abrasive cleaners or solvents on the device.
• DO NOT use the device while it is being charged.
CONTRAINDICATIONS
• DO NOT use on patients who have implanted devices that could be affected by a
magnetic eld (e.g., pacemakers, drug infusion devices, articial sensing devices).
DEVICE DESCRIPTION
The Motiva Flora® Port Locator is a non-invasive electronic medical device that interacts
exclusively with the Motiva Flora® Tissue Expander product family to locate the injection
port within the tissue expander. Motiva Flora® Port Locator uses a radiofrequency
identication (RFID) wireless system comprising two components: tags and readers. The
Motiva Flora® Port Locator (reader) has an antenna that emits radio waves and receives
signals back from the RFID tag.

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The air wound coil (a passive RFID tag) is a component that is located inside the needle
stop of the Motiva Flora® Tissue Expander product family and uses radio waves to
communicate its location to the Motiva® Port Locator. This wireless system locates the
center of the injection port. The user interface of the Motiva Flora® Port Locator includes
LED lights to guide the user during the process. (Figure 2)
Basic UDI-DI: 7445161PortlocatorUY
COMPONENTS
The following components are included inside the Motiva Flora® Port Locator package:
• Port Locator
• USB cable
• Directions for Use
• Motiva Flora® Port Locator Quick Reference Guide
Indicator Lights
Located indicator
Indentation Marking
USB Type C Port
Handle
Status Light
Start button
Guide hole
Figure 2: Port Locator Parts

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TECHNICAL SPECIFICATION
Component Description
Software Version 1.5
Battery
Rechargable Lithium Ion Battery
Weight: 20.5g
Dimensions : 38.6mm x 59mm x 4.5mm
Output: 1250mAh
Nominal voltage: 3.7 V
ERP (Effective Radiated Power) 80.37 dB(uV/m) ± 20%
Case
ABS material
Overall dimensions: Height: 18-23mm,
Width: 49.9mm, Depth: 201.44mm
Resonance frequency 135.35 KHz
Indicators 1 Illuminated button “start”
1 illuminated circle white “location indicators”
1 Illuminated circle green “located”
USB Cable Type C-USB Port
WARNING: There are no user-serviceable parts in the device.
BATTERY
Motiva Flora® Port Locator is equipped with a Lithium-Ion polymer rechargeable battery.
Battery Status Indicator (Figure 3)
• Solid white: Ready to be used
• Blinking Orange: Battery needs to be charged
• Blinking Blue: Charging in process
• Solid Blue: The device is fully charged
WARNING: Solid Red light indicates detection of interference and/or fault condition;
please do not try to use the device.
BATTERY RECHARGING INSTRUCTIONS:
The device’s battery has an operating voltage of 3.7 V and can be easily recharged with a
USB cable: Motiva Flora® Port Locator includes an IEEE 1394 Cable USB for Type C USB
Port.

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ON
FIXED WHITE
FIXED WHITE
FIXED WHITE FIXED WHITE
FIXED GREEN
BLINKING ORANGE BLINKING BLUE FIXED BLUE FIXED RED
PORT LOCATION
DEVICE ON & PORT LOCATION BATTERY STATUS RISK
PORT LOCATED LOW BATTERY CHARGING CHARGED ALERT
NOTE: Wall charger must be approved
IEC 60950 Class II power supply. Output
voltage DC 5V@1A. Input voltage AC
100V/240V and Input voltage frequency
50Hz/60Hz depends on the country’s
standard.
WARNING:
• The device must be used exclusively
with the Motiva Flora® Tissue Expander
product family.
• The device must be connected to an
appropriate power source.
• The use of accessories, transducers,
and cables other than those specied
or provided by the manufacturer
of this equipment could result in
increased electromagnetic emissions Figure 3: Battery status indicators

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or decreased electromagnetic immunity of this equipment and result in improper
operation.
• The device must not be used in a potentially explosive environment. Do not turn on the
Motiva Flora® Port Locator in potentially explosive environments, such as gas stations.
Motiva Flora® Port Locator usage is restricted in areas with fuel, chemical plants, or
where blasting operations are in progress.
• DO NOT use the device while it is being charged.
• NEVER use the device when the status light is blinking orange.
ELECTROMAGNETIC SAFETY TESTING
Test Power input voltage Line frequency
Electromagnetic radiation
disturbance (radiated
EMISSIONS) CISPR 11. 5 VDC N/A
ELECTROSTATIC
DISCHARGE IMMUNITY IEC
61000-4-2
Motiva Flora® Port Locator shall be able
to withstand ±8 kV air discharge and ±8
kV contact discharge without damage. N/A
Test Power input voltage Line frequency
IMMUNITY to proximity
elds from RF wireless
communications equipment
IEC 61000-4-3 (interim
method)
A eld of 10 V/m modulated by a 1 kHz
80% AM modulation over the frequency
range of 90 kHz to 80000 kHz. N/A
IMMUNITY to conducted
DISTURBANCES induced
by RF elds (conducted RF
DISTURBANCE IMMUNITY)
– a.c. mains IEC 61000-4-6
5V rms, 90 KHz to 80 MHz with an 80%
AM with a 1 KHz sine wave AC & DC
power 5V rms sig/control >3 m, 90 KHz
to 80 MHz with an 80% AM with a 1 KHz
sine wave.
N/A
IMMUNITY to conducted
DISTURBANCES induced
by RF elds (conducted
disturbance immunity) – SIP/
SOP PORTS IEC 61000-4-6
5V rms, 90 KHz to 80 MHz with an 80%
AM with a 1 KHz sine wave AC & DC
power 5V rms sig/control >3 m, 90 KHz
to 80 MHz with an 80% AM with a 1 KHz
sine wave.
N/A
Power frequency magnetic
eld IMMUNITY IEC 61000-
4-8. 30 A/m at 60 Hz. N/A

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INSTRUCTIONS FOR USE
• “Motiva Flora® Port Locator Quick Reference Guide” is included inside the device’s box
as a quick instructions reference guide to avoid errors during its use. Keep it handy for
future reference.
• The Motiva Flora® Port Locator functionality is not affected when in the presence of
devices like smartphones, tablets, laptops and Wi node modules.
NOTE:
• Motiva Flora® Port Locator can be safely used to a temperature range of -20 °C to +
39 °C.
• Motiva Flora® Port Locator can be safely used at a relative humidity range of 30 % to
75 %.
• Motiva Flora® Port Locator can be safely used at a atmospheric pressure range of 70,0
kPa to 106.0 kPa.
PRECAUTIONS: Read the instructions carefully before using the device. Failure to read the
instructions may cause unnecessary risk to the patient.
WARNING:
• Having two Motiva® Port Locators within thirty centimeters (12 inches) of each other
may cause interference and affect the localization of the injection port.
• Motiva Flora® Port Locator’s strength is affected by metallic materials, be careful to use
Motiva® Port Locator at least 15 centimeters (6 inches) away from metallic surfaces.
• Not for use in an oxygen-rich environment and ammable anesthetics.
1. PRELIMINARY PRODUCT EXAMINATION
Verify out of the sterile eld that the Motiva Flora® Port Locator’s lights come on when near
the breast expander; it is unnecessary to open the tissue expander packaging.
2. CLEANING THE DEVICE
Motiva Flora® Port Locator is a nonsterile device. Therefore, before reusing the locator for
subsequent lling, it must be cleaned and disinfected using a lint-free cotton cloth and
isopropyl alcohol. NEVER use abrasive products or solvents. (Figure 4)
Warning: DO NOT USE the Motiva Flora® Port Locator if it comes in contact with blood
or mucous membranes. Users must disinfect per hospital procedures and discard the Port
Locator.

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3. TURNING ON THE DEVICE
Caution: To avoid
interference, turn on the
Motiva Flora®Port Locator
30 cm (12 inches) away from
the Motiva Flora®Tissue
Expander product family. A
solid red light will turn on if
you omit this indication.
The device includes an ON
button (Figure 5). A white
light indicates that the Motiva
Flora® Port Locator is on.
• Turn on the Port Locator
by pressing the button and
release once the white light
ring is turned ON.
Verify out of the
sterile field that the
Motiva Flora®Port
Locator’s lights come
on when near the
breast expander.
ON
OFF
The device will turn
off automatically
after 1 min
without use.
Figure 4: Cleaning and disinfecting the device. Figure 5: Power button.

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Figure 6: Scan port. Figure 7: Locating injection port.
4. LOCATING THE
INJECTION PORT
• Place the device near the
breast and move it around
looking for the injection
port. (Figure 6)
• White lights will turn on
guiding the location of the
port. (Figure 7)

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• Once the injection port is
located, a green light ring
will turn on. (Figure 8)
Marking:
• Hold the device steady
and mark the location of
the injection through the
opening of the device
with a surgical marker
perpendicular to the
breast skin and/or pressing
down rmly on the device
to create a temporary
indention on the skin
where the port is located.
(Figure 9)
Figure 8: Injection port location. Figure 9: Marking injection point.

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90°
Figure 10: Injection point. Figure 11: Needle insertion.
5. INSERT THE NEEDLE
• Remove the Motiva Flora®
Port Locator and use the
marked point or the center of
the indentation on the skin as
guidance for the injection site.
(Figure 10)
• Insert the needle at 90 degrees
from the breast and begin the
tissue expander lling. (Figure
11)
NOTE: Fill the tissue expander
according to the Directions for
Use for the Motiva Flora® Tissue
Expander product family.
WARNING: If injections are made
outside the injection port, leakage
can occur.

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STORAGE AND HANDLING CONDITIONS
Packaged units should be stored in a designated area within the hospital/ clinic, stored
at, protected from excessive temperature (below -20 °C or above 39 °C), light, and
moisture (80% or above). Keep it dry. Precautions should be made during transportation
of the units to avoid excessive movement; the device can be broken or damaged if not
handled carefully.
EXPECTED BENEFITS
Motiva Flora® Port Locator with RFID technology for locating the breast tissue expander’s
integrated port facilitates the potential benet, of being compatible with imaging
methods, and may increase the convenience of using Motiva Flora® Tissue Expander
product family during clinical management without affecting the safety or effective tissue
expansion performance.
The Motiva Flora® Tissue Expander product family needle stops are made of a plastic
component (PEEK Optima® LT1), which encloses the needle stop coil made of copper
and a soldered RFID chip, nonmagnetic metals with low magnetic susceptibility. These
non-ferromagnetic materials for the needle stop and an RFID-based port locator allow an
implanted patient to undergo MRI under certain conditions (MR conditional).
INFORMATION ON LIFE EXPECTANCY
The package labelling contains the expiration date of the device.
MAINTENANCE
Motiva Flora® Port Locator does not require any maintenance. The user should NEVER
attempt to service or repair the device. In case the device stops working, please contact
Establishment Labs through the website: www.motiva.health. To comply with the return
and disposal of electrical and electronic equipment. Please send the Motiva Flora®Port
Locator for disposal to:
Establishment Labs
Coyol Free Zone and Business Park Building
4th Street, Building B-15, Alajuela, Costa Rica.
Phone: [phone]
Email: [email protected]
Website: www.motiva.health
NOTE: Do not dispose of the battery in re. Battery disposal regulations vary on national,
state/provincial, and local bases. Disposal must be conducted following the applicable
regulations.

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PRODUCT ORDERING
To order directly, or for product information, please contact your local Establishment Labs
S.A. representative. In case there is no local representative contact:
Establishment Labs
Coyol Free Zone and Business Park Building
4th Street, Building B-15, Alajuela, Costa Rica.
Phone: [phone]
Website: www.motiva.health/support
REPORTING AND DEVICE RETURN EFFORTS
In the event of a Motiva Flora® Port Locator malfunction, the device must be returned
to the local Establishment Labs representative. In case there is no local representative
available, report directly to:
Establishment Labs S.A.
Coyol Free Zone and Business Park Building,
4th Street, Building B-15, Alajuela, Costa Rica
Phone: [phone]
Website: www.motiva.health/support/
NOTE: Any severe incident with Motiva Flora®Port Locator should be reported to
Establishment Labs and the competent authority in which the patient is established, if
applicable according to local regulations.
RETURNED GOODS POLICY
Product returns should be handled through the local Establishment Labs representative. In
case there is no local representative available, report directly to:
Establishment Labs
Coyol Free Zone and Business Park Building
4th Street, Building B-15, Alajuela, Costa Rica.
Phone: [phone]
Website: www.motiva.health/support
All package seals must be intact for goods to be eligible for return. Returned products
may be subject to a restocking fee. For more information, please contact the local
Establishment Labs representative.
ESTABLISHMENT LABS WARRANTY
Establishment Labs warrants that this product is free of manufacturing defects at the

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time of its shipment. Establishment Labs shall not be responsible for any incidental or
consequential loss, damage, or expenses directly or indirectly arising from the use of
this product. If Establishment Labs determines the product was defective when shipped
by the manufacturer, Establishment Labs’ sole responsibility is to replace the product.
Establishment Labs S.A assumes no further liability. This warranty is in lieu of and excludes
all other warranties not expressly set forth herein, whether express or implied by operation
of law, or otherwise, including, but not limited to, any implied warranties of merchantability,
suitability for use or performance.
LEGAL MANUFACTURER
ESTABLISHMENT LABS S.A.
Coyol Free Zone and Business Park Building
4th Street, Building B-15, Alajuela, Costa Rica.
Phone: [phone]
Email:[email protected]
Website: www.motiva.health
Non-harmonized symbols in product labeling
Symbol Meaning Symbol Meaning
Federal Communications
Commission register id
number
MET Labs listing number: this
means that the device has been
evaluated for a limited range of
hazards or suitability for use under
limited or special conditions.
Waste electrical and
electronic equipment
(WEEE)
Refer to the directions for use
Conformité Européenne
mark
Type B applied part: the backside
of the device could be in touch
with the patient.
Ingress protection Rating Non-sterile
EUROPEAN REPRESENTATIVE
Emergo Europe: Prinsessegracht 20,
2514 AP
The Hague, The Netherlands.
EUROPEAN IMPORTER
EDC Motiva BVBA
Nijverheidsstraat 96, Wommelgem
Antwerp, 2160 Belgium
Phone: [phone]

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Do not used if package is
damaged Keep dry
Temperature limit Humidity limitation
Fragile, handle with care Consult instructions for use
Caution Atmospheric pressure limitation
Manufacturer Medical Device
Date of manufacture Serial Number
Unique Device Identifier Quantity of accesories or medical
devices included in the package.
Catalogue number Authorized representative in the
European Community
This way up Keep away from sunlight
Stacking limit by number

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INSTRUCCIONES DE USO DEL LOCALIZADOR DEL PUERTO MOTIVA FLORA®
Establishment Labs S.A.
PRECAUCIÓN:
• El uso de este producto está restringido únicamente a profesionales sanitarios con
formación cualicada y autorizados por los colegios nacionales correspondientes. El
uso de este producto por parte de profesionales no cualicados puede dar lugar a
resultados estéticos decientes y efectos adversos graves sobre la salud.
• La legislación federal (EE. UU.) restringe la venta de este dispositivo a profesionales
sanitarios autorizados.
INTRODUCCIÓN
Este documento ofrece un resumen de la información esencial sobre el localizador del
puerto Motiva Flora®, que incluye la descripción del dispositivo, indicaciones de uso,
contraindicaciones, advertencias, precauciones, temas relevantes, política de devolución
de productos y garantía.
TEMAS RELEVANTES QUE SE DEBEN ANALIZAR CON LA PACIENTE
Los médicos y los profesionales sanitarios deben leer y entender bien el contenido de este
documento y asegurarse de responder a todas las preguntas o atender
todas las inquietudes de las pacientes antes de utilizar el dispositivo.
USO PREVISTO/INDICACIONES DE USO
El localizador del puerto Motiva Flora®(gura 1) interactúa exclusivamente
con la familia de productos de expansión tisular Motiva Flora®para
localizar fácilmente el puerto integrado del expansor tisular mamario y
permitir su llenado preciso por inyección.
ADVERTENCIA: Lea atentamente el manual del usuario (este documento)
antes de utilizar el dispositivo. No leer las instrucciones puede provocar
situaciones adversas para la paciente.
PACIENTES PREVISTAS
El localizador del puerto Motiva Flora® está indicado para su uso
en pacientes que necesitan una reconstrucción mamaria por etapas
mediante expansor tisular con la familia de productos de expansión
tisular Motiva Flora®.
Figura1: Localizador del puerto Motiva Flora®

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PRECAUCIONES
El localizador del puerto Motiva Flora®solo se debe utilizar como se indica en este
documento.
• Antes de su uso, lea atentamente las instrucciones de uso.
• El incumplimiento de las instrucciones de seguridad puede dañar el dispositivo o
causar lesiones a la paciente.
• Compruebe que el localizador del puerto Motiva Flora® no esté dañado antes de
utilizarlo.
• NO exponga el dispositivo a temperaturas extremas (inferiores a -20 °C o superiores a
39 °C), a la luz solar directa ni a una humedad extrema (80 % o más).
• Los hospitales y clínicas son entornos adecuados para utilizar el localizador del puerto
Motiva Flora®, excepto en áreas cercanas a perturbaciones electromagnéticas (EM)
elevadas, otros dispositivos de radiofrecuencia (RF) activa o salas blindadas contra RF.
• No se deben utilizar equipos portátiles de comunicación por RF (incluidos los periféricos
como cables de antena y antenas exteriores) a menos de 1 metro de cualquier parte
del localizador del puerto Motiva Flora®, incluidos los cables especicados por el
fabricante. De lo contrario, el funcionamiento de este equipo podría verse afectado.
• Las características de emisión de este equipo lo hacen apto para su uso en zonas
industriales y hospitales; si se utiliza en un entorno residencial, este equipo podría no
ofrecer una protección adecuada para los servicios de comunicación de radiofrecuencia.
Es posible que el usuario deba tomar medidas paliativas, como la reubicación o
reorientación del equipo.
• NO modique el dispositivo en modo alguno.
• NO utilice limpiadores abrasivos ni disolventes en el dispositivo.
• NO utilice el dispositivo mientras se esté cargando.
CONTRAINDICACIONES
• NO lo utilice en pacientes que tengan dispositivos implantados que puedan verse
afectados por un campo magnético (p. ej., marcapasos, dispositivos de perfusión de
fármacos, dispositivos de detección articial).
DESCRIPCIÓN DEL DISPOSITIVO
El localizador del puerto Motiva Flora® es un producto sanitario electrónico no invasivo
que interactúa exclusivamente con la familia de productos de expansión tisular Motiva
Flora® para localizar el puerto de inyección dentro del expansor tisular. El localizador del

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puerto Motiva Flora® utiliza un sistema inalámbrico de identicación por radiofrecuencia
(RFID) que consta de dos componentes: etiquetas y lectores. El localizador del puerto
(lector) Motiva Flora® tiene una antena que emite ondas de radio y recibe señales de la
etiqueta RFID.
La bobina de aire (una etiqueta RFID pasiva) es un componente que se encuentra dentro
del tope de aguja de la familia de productos de expansión tisular Motiva Flora® y utiliza
ondas de radio para comunicar su ubicación al localizador del puerto Motiva®. Este
sistema inalámbrico localiza el centro del puerto de inyección. La interfaz de usuario
del localizador del puerto Motiva Flora® tiene luces LED que guían al usuario durante el
proceso (Figura 2).
UDI-DI básico: 7445161PortlocatorUY
COMPONENTES
En el envase del localizador del puerto Motiva Flora® se incluyen los siguientes
componentes:
• Localizador del puerto
• Cable USB
• Instrucciones de uso
• Guía de referencia rápida del localizador del puerto Motiva Flora®Figura2: Partes del localizador del puerto
Mango
Luz de estado
Botón de inicio
Oricio guía
Puerto USB tipo C
Marca de depresión
Indicador de
localización
Luces
indicadoras