MetaOptima MoleScope II Manuale utente

User’s Manual

MoleScope II, TrikoScope, CapilloScope

P002 - 004 - IFU

2022/04/28 V3

EN: Component Name

DE: Komponente

FR: Nom du composant

ES: Nombre del componente

IT: Nome del componente

NL: Naam onderdeel

Mobile Dermatoscope

Mobil-Dermatoskop

Dermatoscope mobile

Dermatoscopio móvil

Dermatoscopio mobile

Mobiele dermatoscoop

Contact Cap

Kontaktkappe

Capuchon de contact

Tapa de contacto

Cappuccio di contatto

Contactkapje

Non-Contact Cap

erührungslose Kappe

Capuchon sans contact

Tapa sin contacto

Cappuccio non di contatto

Niet-contactkapje

USB Charging Cable

USB-Ladekabel

Cabine de chargement USB

Cable de carga USB

Cavo di ricarica USB

USB-oplaadkabel

Universal Attachment Plate (for Model U)

Universal-Befestigungsplatte (Modell U)

Plaque de ﬁxation universelle (pour le modèle U)

Placa de acoplamiento universal (para el modelo U)

Piastra di attacco universale (per il modello U)

Universele bevestigingsplaat (voor model U)

Rubber Attachment (for Models A, A+, B, B+)

Gummiaufsatz (Modelle A / A+ / B / B+)

Fixation en caoutchouc (pour les modèles A, A+, B, B+)

Accesorio de goma (para modelos A, A+, B, B+)

Attacco di gomma (per i modelli A, A+, B, B+)

Rubberen bevestigingsstuk (voor model A, A+, B, B+)

Please read this user manual carefully before using the device.

MoleScope is a battery-powered dermatoscope intended to be attached to smartphones and

tablets to take images of skin, scalp, hair, nail, and other body surfaces with high magniﬁcation

and cross-polarized light. It is a reusable, non-invasive device for imaging and documentation

only.

English

Intended Use

Indications of Use and Contraindications

The device is indicated for use in combination with a smartphone or a tablet when magniﬁed

images of the skin, scalp, hair, nail, and other body surfaces of any patient demographic are

required. The device should not be used on open wounds or on any other sensitive areas. The

device is intended to be used by professional healthcare workers or lay persons.

Cautions

• Do not look directly into the bright LED light. Eyes must be closed during facial

examination.

• Do not attempt to open the device for any reason.

• Do not attempt to change the device battery. The battery is not replaceable.

• Do not use the device to image sensitive areas, open wounds, and surfaces near the

eyes, ears, nose, and mouth.

• Check your device before use if it has been dropped.

• Follow the instructions in this document to clean and disinfect contact and non-

contact caps in between patients.

• Keep the device and detachable components out of reach of children and pets. If

swallowed, seek medical attention immediately.

• Do not use the device while it is in charging mode.

• This device contains magnets. Do not use it without ﬁrst consulting your doctor if you

wear a pacemaker or other medical implant.

Consult a healthcare professional to determine your skin assessment plan.

For EU/UK Residents

Any serious incident that has occurred in relation to the device should be reported to the

manufacturer and the competent authority of the EU Member State in which the user and/or

patient is established or in case of UK residents, to the manufacturer and to the secretary of

State in the United Kingdom.

Components Include

Device Models A / A+ / B / B+: A mobile dermatoscope device with a contact cap and a

rubber attachment, a non-contact cap, a microﬁber cleaning cloth, a microﬁber device bag

and a charging cable.

Set Up Instructions for Device Models

A / A+ / B / B+

These models come in dierent sizes to ﬁt the speciﬁcations

of your smartphone/ tablet and are typically recommended

for medical professionals or patients looking for an

attachment to a speciﬁc smartphone/tablet device. Please

refer to MetaOptima’s website for the most updated list of

smartphones and tablets.

To attach the device to your smartphone/tablet, place it over

the smartphone camera and ﬁrmly squeeze the attachment

part together. The device lens should be perfectly aligned

with the camera lens. For best results, you should remove any

case and screen protectors you have on your smartphone/

tablet.

Device Model U: A mobile dermatoscope device with a contact cap, a universal attachment

plate, a non-contact cap, a microﬁber cleaning cloth, a microﬁber device bag and a charging

cable.

Set Up Instructions for Device Model U

This model is compatible with any smartphone/tablet and recommended for medical

professionals or patients with a smartphoneor/tablet that are not covered by MoleScope

models A, A+, B, B+ or want to switch between dierent smartphone/tablet devices.

Step 1: Twist and lift the lid to reveal the sticky pad

underneath. Make sure the sticky pad is clean and

free of dust, dirt and oil. If the pad is dirty or losing its

adhesive grip, simply wash under water and let air dry

prior to your next imaging session.

Do not use hot water, cleaning agents, or a

hair dryer to quicken the process. Avoid direct

contact with the sticky pad!

To learn how you can get started, follow the steps below.

Step 2: Clean the back of your smartphone, tablet, or device case with the provided microﬁber

cloth to remove any smudges, dirt, or oil. Next, align the guide marks of the Attachment Plate

with the center of the smartphone/tablet camera and gently push to secure the plate. If the

adhesion is not adequate, you have the option of attaching the plate to your smartphone or

tablet case that has a hard and smooth back. Avoid rubber, leather, and textured surfaces.

If your smartphone has multiple camera lenses, align the attachment with the center of

the main camera. For a reference of popular smartphone model camera placements visit

www.molescope.com/molescope2

Step 3: Place the MoleScope device on

the universal attachment plate. You will

hear a clicking noise, indicating that the

device is magnetically locked into place.

Press the power button to turn on your

device and begin your imaging session.

Permanent Attachment to a Smartphone or Tablet Case

If your device will be used frequently, you may peel o

the sticky pad from the universal attachment plate and

replace with provided double-sided tape. Repeat steps

2 and 3, then simply pull to remove the MoleScope

device. Only use the permanent adhesive on the case

and do not attach directly to your smartphone or

tablet.

Battery and Charging

We recommend that customers fully charge their device before their ﬁrst use. Complete

charging duration is 90 minutes. Do not use the device while it is on charging mode. To

conserve energy, this product is designed to automatically turn o after 4 minutes. The battery

can be expected to supply multiple sessions. The device has a low battery indicator. If the light

indicator is ﬂashing red, the battery is low and it may need to be recharged. To charge, plug the

device into a USB port. While charging, the charge indicator will glow red; when fully charged,

it will appear green. This product uses a special rechargeable lithium-polymer battery, which

is not replaceable.

Cleaning and Disinfection

The exterior and contact plate of your MoleScope should be cleaned by wiping with isopropyl

alcohol (70% vol.) or a disinfectant solution in between users. Turn the device o and

disconnect it from the charging cable before cleaning and disinfection.

Troubleshooting

Your product is designed for trouble-free operation. There are no adjustments to be made nor

is any special servicing required. Never attempt to open the device for any reason.

Step 4: When the imaging session is over, pull to remove the MoleScope device, then gently

twist the universal attachment plate to detach it from your smartphone or tablet and place the

lid back on the sticky pad. Do not grab and lift the plate!

Do not use alcohol or disinfectants in the optical areas of the unit.

Do not use abrasive material on any part of the equipment or immerse the device in

liquid. Do not autoclave.

This device lens should be treated as high-quality photographic equipment. It should be

cleaned with the provided microﬁber cloth or an air duster, and protected from harmful

chemicals.

Warranty

Your device has a 2-year warranty. For warranty issues, please contact the reseller or store

where you bought the product. The serial number is labeled on the box and back of your

device.

No Light: Fully recharge the battery and check again. If the condition persists, stop using your

device and contact [email protected]

LED Fails: The LEDs used in your product are designed to last over 50,000 hours. If any

one of the LEDs fails, stop using your device and contact [email protected]

Mechanical Malfunction: Stop using your device and contact [email protected]

If your product has any other problems or is not working properly, please stop using it and

check our website (www.metaoptima.com) for the most current troubleshooting information.

Specications

• 10x Optical magniﬁcation with 16 mm wide ﬁeld of view

• 6 bright white LEDs with polarization rate of 99.97%

• Contact and non-contact imaging caps with easy magnetic attachment

• Anti-reﬂective glass contact plate with scale

• ON/OFF switch with 4 minutes auto turn o and low-battery/charging indicator

• Rechargeable lithium-ion battery with 6 hours of working time

• USB 2.0 high speed charging cable

• Smartphone and tablet compatibility

Disposal

The product must be recycled as separated electrical and electronic devices. Please observe

the relevant state-speciﬁc disposal regulations.

Environmental conditions for operation

0 °C to +45 °C

45 % to 75 % Relative Humidity

700 hPa to 1060 hPa

Environmental conditions for storage

+5 °C to +35 °C

45 % to 75 % Relative Humidity

500 hPa to 1060 hPa

Environmental conditions for transport

-10 °C to +55 °C

45 % to 75 % Relative Humidity

500 hPa to 1060 hPa

Lesen Sie dieses Benutzerhandbuch vor Gebrauch des Gerätes sorgfältig durch.

Das MoleScope ist ein batteriebetriebenes Dermatoskop, das Benutzer an Smartphones und

Tablets anschließen können, um mit hoher Vergrößerung und kreuzpolarisierter Beleuchtung

Aufnahmen von Haut, Kopfhaut, Haar, Nägeln und anderen Körperstellen anzufertigen.

Das wiederverwendbare, nicht-invasive Gerät darf nur für Bildgebung und Dokumentation

eingesetzt werden.

DEUTSCH

Verwendungszweck

Verwendungszwecke und Kontraindikationen

Das Gerät ist für die Verwendung in Kombination mit einem Smartphone oder einem Tablet

geeignet, wo vergrößerte Aufnahmen von Haut, Kopfhaut, Haar, Nägeln oder anderen

Körperoberﬂächen beliebiger Patienten benötigt werden. Das Gerät darf nicht auf oenen

Wunden oder sonstigen empﬁndlichen Stellen angewendet werden. Das Gerät ist für die

Anwendung durch medizinisches Fachpersonal oder Laien vorgesehen.

Vorsichtshinweise

• Nie direkt in die LED-Beleuchtung blicken. Die Augen müssen bei Untersuchungen im

Gesichtsfeld geschlossen sein.

• Nicht versuchen, das Gerät aus irgendeinem Grund zu önen.

• Nicht versuchen, die Gerätebatterie auszuwechseln. Die Batterie ist nicht austauschbar.

• Verwenden Sie das Gerät nicht zur Abbildung von empﬁndlichen Stellen, oenen

Wunden und Hautﬂächen in der Nähe von Augen, Ohren, Nase und Mund.

• Prüfen Sie vor Gebrauch des Geräts, ob es zuvor auf den Boden gefallen ist.

• Reinigen und desinﬁzieren Sie die kontaktbehafteten und berührungslosen

Bildgebungskappen vor dem Einsatz am nächsten Patienten entsprechend den

Anweisungen in diesem Dokument.

• Bewahren Sie das Gerät und abnehmbare Komponenten außerhalb der Reichweite von

Kindern und Haustieren auf. Suchen Sie bei Verschlucken umgehend einen Arzt auf.

• Das Gerät nicht verwenden, solange es aufgeladen wird.

• Das Gerät enthält Magnete. Verwenden Sie das Gerät erst nach Rücksprache mit Ihrem

Arzt, wenn Sie einen Herzschrittmacher oder ein anderes medizinisches Implantat

tragen.

Legen Sie zusammen mit medizinischem Fachpersonal einen Hautuntersuchungsplan fest.

Für in der EU/im Vereinigten Königreich ansässige Personen

Jeder schwerwiegende Vorfall im Zusammenhang mit dem Produkt sollte dem Hersteller

und der zuständigen Behörde des EU-Mitgliedstaats, in dem der Anwender und/oder Patient

niedergelassen ist, bzw. im Falle von im Vereinigten Königreich ansässigen Personen dem

Hersteller und dem Minister des Vereinigten Königreichs gemeldet werden.

Komponenten des Geräts

Gerätemodelle A / A+ / B / B+: Ein mobil einsetzbares Dermatoskop-Gerät mit einer

Kontaktkappe und einem Gummiaufsatz, einer berührungslosen Kappe, einem Mikrofaser-

Reinigungstuch, einem Mikrofaser-Aufbewahrungsbeutel und einem Ladekabel.

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