Motiva Flora Manual

EN EN

Motiva Flora®Port Locator

Directions for Use

EN EN

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

EN EN

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.

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

EN EN

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

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

EN EN

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.

EN EN

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.

• 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.

Verify out of the

sterile ﬁeld that the

Motiva Flora®Port

Locator’s lights come

on when near the

breast expander.

OFF

The device will turn

off automatically

after 1 min

without use.

Figure 4: Cleaning and disinfecting the device. Figure 5: Power button.

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.

4. LOCATING THE

INJECTION PORT

• Place and move the device

as close as possible to the

surface of the breast to

obtain the best results in

locating the injection port.

• White lights will turn on

guiding the location of the

port. (Figure 7)

Figure 6: Scan port. Figure 7: Locating injection port.

Figure 8: Injection port location. Figure 9: Marking injection point.

• 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)

EN EN

Figure 10: Injection point.

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.

STORAGE AND HANDLING CONDITIONS

Packaged units should be stored at in a designated area within the hospital/clinic,

protected from excessive temperature (below 0 °C or above 39 °C), light, and moisture

(below 35 % or above 75 %). 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

EN EN

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 expected service life of the Port Locator is 30 months upon receipt by the surgeon.

Establishment Labs does not guarantee the device’s functionality after its expected

service life.

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, 20113, Costa Rica.

Phone: +506 2434-2400

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.

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, 20113, Costa Rica.

Phone: +506 2434-2400

Website: www.motiva.health/support

EN EN

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, 20113, Costa Rica

Phone: +506 2434-2400

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, 20113, Costa Rica.

Phone: +506 2434-2400

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

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.

EN EN

LEGAL MANUFACTURER

ESTABLISHMENT LABS S.A.

Coyol Free Zone and Business Park Building

4th Street, Building B-15, Alajuela, Costa Rica.

Phone: +506 2434-2400

Email:[email protected]

Website: www.motiva.health

EUROPEAN REPRESENTATIVE

Emergo Europe: Prinsessegracht 20, 2514 AP

The Hague, The Netherlands.

EUROPEAN IMPORTER

EDC Motiva BVBA

Nijverheidsstraat 96, Wommelgem

Antwerp, 2160 Belgium

Phone: +32 34324170

Symbols used in product labeling (including non-harmonized symbols)

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.

Protected against

splashing water Non-sterile

FCC ID: 2A9RPMFPL001

EN EN

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 Importer

Country of

manufacture UK conformity assessed

EN EN

EN Hereby, Establishment Labs declares that the radio equipment type Motiva Flora® Port Locator MFPL-001 is in compliance with Directive 2014/53/EU.The full text of the EU declaration of conformity is available at the following

internet address: / BG С настоящото Establishment Labs декларира, че радиооборудването тип локатор на порт Motiva Flora® MFPL-001 е в съответствие с Директива 2014/53/ЕС. Пълният текст на ЕС декларацията за

съответствие е достъпен на следния интернет адрес: / CS Tímto společnost Establishment Labs prohlašuje, že typ rádiového zařízení lokátor portu Motiva Flora® MFPL-001 je v souladu se směrnicí 2014/53/EU. Úplné znění EU

prohlášení o shodě je k dispozici na této internetové adrese: / DA Establishment Labs erklærer hermed, at radioudstyrstypen Motiva Flora® portnder MFPL-001 er i overensstemmelse med direktiv 2014/53/EU. Den fuldstændige

tekst for EU-overensstemmelseserklæringen ndes på følgende internetadresse: / NL Hierbij verklaart Establishment Labs dat het type radioapparatuur Motiva Flora®-poortlokalisator MFPL-001 conform is met Richtlijn 2014/53/

EU. De volledige tekst van de EU-conformiteitsverklaring kan worden geraadpleegd op het volgende internetadres: / ET Establishment Labs deklareerib käesolevaga, et raadioseadme tüüp Motiva Flora® Port Locator MFPL-001

vastab direktiivile 2014/53/EL. EL-i vastavusdeklaratsiooni täistekst on saadaval järgmisel internetiaadressil: / GD Dearbhaíonn Establishment Labs leis seo go bhfuil an cineál trealaimh raidió Motiva Flora® Port Locator MFPL-001 i

gcomhréir le Treoir 2014/53/AE. Tá téacs iomlán an Dearbhaithe Comhréireachta AE le fáil ag an seoladh Idirlín seo a leanas: / DE Establishment Labs erklärt hiermit, dass die Funkanlage vom Typ Motiva Flora® Port Locator MFPL-

001 die Richtlinie 2014/53/EU erfüllt. Der Gesamtwortlaut der EU-Konformitätserklärung ist unter folgender Internet-Adresse abrufbar: / EL Δια της παρούσας, η Establishment Labs δηλώνει ότι ο εντοπιστής θύρας Motiva Flora®

τύπου ραδιοεξοπλισμού MFPL-001 συμμορφώνεται με την Οδηγία 2014/53/ΕΕ.Το πλήρες κείμενο της δήλωσης συμμόρφωσης της ΕΕ υπάρχει διαθέσιμο στην ακόλουθη διαδικτυακή διεύθυνση: / ES Por el presente, Establishment

Labs declara que el localizador de puerto Motiva Flora® MFPL-001 es un tipo de dispositivo de radiofrecuencia que cumple la directiva 2014/53/UE. El texto íntegro de la declaración de conformidad de la UE se puede consultar en

la siguiente dirección de Internet: / FI Establishment Labs ilmoittaa täten, että radiolaitetyyppinen MFPL-001 Motiva Flora® Port Locator -paikannin on direktiivin 2014/53/EU mukainen. EU:n vaatimustenmukaisuusvakuutus on

saatavilla kokonaisuudessaan seuraavasta osoitteesta: / FR Establishment Labs déclare par les présentes que le localisateur de port Motiva Flora® MFPL-001 est un appareil radio conforme à la directive européenne 2014/53/UE. Le

texte de la déclaration de conformité UE peut être consulté dans son intégralité à l’adresse Internet suivante: / HR Tvrtka Establishment Labs izjavljuje da je radijska oprema lokatora porta tipa Motiva Flora® MFPL-001 u skladu s

Direktivom 2014/53/EU. Puni tekst EU izjave o sukladnosti dostupan je na sljedećoj internetskoj adresi: / HU Az Establishment Labs kijelenti, hogy a Motiva Flora® portlokátor MFPL-001 elnevezésű rádiófrekvenciás berendezéstípus

megfelel a 2014/53/EU irányelvnek. Az EU-s megfelelőségi nyilatkozat teljes szövege elérhető a következő internetes címen: / IT Con la presente, Establishment Labs dichiara che l’apparecchiatura radio di tipo localizzatore di port

Motiva Flora® MFPL-001 è conforme alla Direttiva 2014/53/UE. Il testo completo della dichiarazione di conformità UE è disponibile sul seguente sito web: / LV Ar šo Establishment Labs apliecina, ka radioiekārtas veida MFPL-001

Motiva Flora® pieslēgvietas meklētājs atbilst Direktīvas 2014/53/ES prasībām. Pilns ES atbilstības deklarācijas teksts ir pieejams šajā tīmekļa vietnē: / LT „Establishment Labs“ pareiškia, kad radijo įrangos tipo „MFPL-001 Motiva

Flora®“ prievado vietos nustatymo įtaisas atitinka Direktyvą 2014/53/ES. Visas ES atitikties deklaracijos tekstas pasiekiamas toliau nurodytu interneto adresu: / MT Hawnhekk, Establishment Labs tiddikjara li t-tagħmir tar-radju

tat-tip Lokalizzatur tal-Port ta’ Motiva Flora® MFPL-001 hu konformi mad-Direttiva 2014/53/UE. It-test sħiħ tad-dikjarazzjoni ta’konformità tal-UE jinsab disponibbli fuq l-indirizz tal-internet li ġej: / PL Establishment Labs deklaruje

niniejszym, że lokalizator portu Motiva Flora® MFPL-001 będący urządzeniem radiowym spełnia wymagania określone w Dyrektywie 2014/53/UE. Pełny tekst deklaracji zgodności UE jest dostępny pod następującym adresem

internetowym: / PT A Establishment Labs declara por este meio que o localizador de porta Motiva Flora® MFPL-001, um tipo de equipamento de rádio, está em conformidade com a Diretiva 2014/53/UE. O texto completo da

declaração UE de conformidade está disponível no seguinte endereço da Internet: / RO Establishment Labs declară prin prezenta că echipamentul radio de tipul localizatorului de port Motiva Flora® MFPL-001 este în conformitate

cu Directiva 2014/53/UE. Textul complet al declarației de conformitate UE este disponibil la următoare adresă de internet: / SK Spoločnosť Establishment Labs týmto vyhlasuje, že rádiové zariadenie typu lokátor portu Motiva Flora®

MFPL-001 spĺňa smernicu 2014/53/EÚ. Úplný text EÚ vyhlásenia o zhode je k dispozícii na nasledujúcej internetovej adrese: / SL Družba Establishment Labs s tem izjavlja, da je radijska oprema vrste lokatorja vrat Motiva Flora®

MFPL-001 skladna z Direktivo 2014/53/EU. Celotno besedilo izjave EU o skladnosti je na voljo na naslednjem internetnem naslovu: / SV Establishment Labs intygar härmed att radioutrustningen av typen MFPL-001 Motiva Flora®

portlokaliserare överensstämmer med kraven i direktivet 2014/53/EU. Den fullständiga texten i EU-försäkran om överensstämmelse åternns på följande internetadress: https://motiva.health/patients-motiva-experience/