Intended Use - MetaOptima MoleScope II Manual Del Usuario

English
Please read this user manual carefully before using the device.

Intended Use

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.
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.
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