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 0 °C or above 39 °C),
direct sunlight, or extreme humidity (below 35 % or above 75 %).
• 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 1.5.2
Battery
Rechargable Lithium Ion Battery
Weight: 20.5g
Dimensions : 38.6mm x 59mm x 4.5mm
Output: 1250mAh
Nominal voltage: 3.7 V
Case
ABS material
Overall dimensions: Height: 18-23mm,
Width: 49.9mm, Depth: 201.44mm
Indicators
1 Illuminated button “start”
1 illuminated circle white “location indicators”
1 Illuminated circle green “located”
USB Cable Type C-USB Port
Wireless technical specications
Complies with: IEC 60601-1, IEC 60601-1-2, AIM 7351731, FCC 47 CFR Part
15 Subparts B and C
Resonance frequency: 135.35 kHz
Maximum effective
radiated power: 87 dBµV/m at 3 m
Modulation: OOK/ASK
Operating range: 0-55 mm (2.165 in) from injection port
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, and (2) this device
must accept any interference received, including interference that may cause undesired
operation. Changes or modications not expressly approved by the party responsible for
compliance could void the user’s authority to operate the equipment. This equipment
has been tested and found to comply with the limits for a Class A digital device, pursuant

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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
to part 15 of the FCC Rules. These limits
are designed to provide reasonable
protection against harmful interference
when the equipment is operated in a
commercial environment. This equipment
generates, uses, and can radiate radio
frequency energy and, if not installed and
used in accordance with the instruction
manual, may cause harmful interference to
radio communications. Operation of this
equipment in a residential area is likely to
cause harmful interference in which case
the user will be required to correct the
interference at his own expense.
WARNING: There are no user-serviceable
parts in the device.
Figure 3: Battery status indicators

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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.
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 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.

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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
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.

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• The Motiva Flora® Port Locator functionality is not affected when in the presence of
devices like smartphones, tablets, laptops and Wi node modules.
• Establishment Labs strongly recommends fully charging the battery before using the
device for the rst time.
NOTE:
• Motiva Flora® Port Locator can be safely used in the temperature range of 0 °C to 39
°C.
• Motiva Flora® Port Locator can be safely used in the relative humidity range of 35 %
to 75 %.
• Motiva Flora® Port Locator can be safely used in the 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 outside the sterile eld that the Motiva Flora® Port Locator’s lights turn on when near
the Tissue Expander. It is not necessary to open the packaging of the Tissue Expander to
verify its functionality before implantation.
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.