2A9RPMFPL001Motiva Flora Port Locator

ENEN 1 Motiva Flora ® Port Locator Directions for Use ENEN 3 DIRECTIONS FOR USE MOTIVA FLORA ® PORT LOCATOR Establishment Labs S.A. CAUTION: • Only health professionals with qualified training and licensed by the corresponding national boards should use it. The use of this product by unqualified 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 filling. 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 ENEN 4 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 specified 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 field (e.g., pacemakers, drug infusion devices, artificial 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 identification (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. EN 5 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 ENEN 6 TECHNICAL SPECIFICATION ComponentDescription 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 specifications 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 modifications 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 EN 7 ON FIXED WHITE FIXED WHITE FIXED WHITEFIXED WHITE FIXED GREEN BLINKING ORANGE BLINKING BLUEFIXED BLUEFIXED RED …

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Input: 3.7V 1.25A www.establishmentlabs.com www.motiva.health Complies with ANSI/AAMI ES 60601-1 CSA C22.2 No. 60601-1 E115143 E115143 FCC ID: 2A9RPMFPL001 Complies with ANSI/AAMI ES 60601-1 CSA C22.2 No. 60601-1

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Radiated Emission Test below 30MHz Front View Radiated Emission Test below 30MHz Rear View Radiated Emission Test below 1GHz Front View Radiated Emission Test below 1GHz Rear View