piomic COMS One Mode D'emploi page 5

1. INTRODUCTION
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The COMS One Therapy System for Combined Optical and
Magnetic Stimulation, hereinafter called "COMS One", is
approved exclusively for the use as specified in these
Instructions for Use.
Please read the information and note that these Instructions
for Use must be kept with the device.
The compact and portable COMS One offers simple and
comfortable wound therapy. Its use of optical and magnetic
stimulation is clinically proven to be effective in promoting
wound healing.
Intended purpose/Indications (When to use the device)
The COMS One Therapy System is intended to promote
wound healing by combined optical and magnetic
stimulation, in addition to standard of care. Indications for the
COMS One Therapy System are chronic leg and foot ulcers.
Contraindications (When not to use the device)
• Active skin cancer, history of skin cancer or any other
localized cancer, precancerous lesions or large moles in
the areas to be treated
• Pregnancy
Intended User Population
The COMS One should only be operated by properly in-
structed adults. Lay users including patients shall only use the
device upon instruction by a professional. All users shall not
be hard of hearing or deaf, must have adequate visual facul-
ty and shall be comfortable with the use of electronic devices.
Intended patient population
The COMS One is intended to be used on patients only
exhibiting conditions as described in the indications for use.
Intended Use Settings
The COMS One system is intended for use in professional
healthcare and home care settings.