User Manual for the FLUXMEDICARE® V2 System
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IFU-FLUXMEDV2 - V.1.0 - 07/2020
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1.2.
Expected use
The FLUXMEDICARE® V2 system is intended to be used by health professionals practising in doctors’ surgeries,
hospitals and clinics for PDT (photodynamic therapy) treatments.
The treatment should only be carried out by an authorised medical professional trained in photodynamic
therapy.
For the PDT treatment, and before exposure to the light, the area of skin to be treated is covered by a gel or
cream containing 5-aminolevulinic acid or an ALA ester or methyl aminolevulinate (not supplied with the
FLUXMEDICARE® V2 system) acting as a photosensitiser. These creams are only available on prescription.
1.3.
Therapeutic indications
Photodynamic therapy is used to treat fine, non-pigmented precancerous skin lesions (actinic keratosis) on the
face and scalp (Olsen Grade 1 to 2).
The target population is adults only.
1.4.
Contraindications
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Product contraindicated for pregnant women.
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Product contraindicated for patients with a history of abnormal photosensitivity.
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Patients allergic to the gel or cream containing 5-aminolevulinic acid or an ALA ester or methyl
aminolevulinate or the excipients in the cream (not supplied), including ground-nut oil, peanuts, or soya.
•
Porphyria
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A patient who is immunosuppressed for therapeutic reasons, an idiopathic or specific illness
1.5.
Precautions for use
The untreated healthy skin beside the lesion does not need to be protected during exposure.
The FLUXMEDICARE® V2 system is intended to be used in combination with a pharmaceutical cream containing
5-aminolevulinic acid or an ALA ester or methyl aminolevulinate, (not supplied with the FLUXMEDICARE® V2
system).
For contraindications please refer to the instruction leaflet for these medicines.
The following adverse effects may occur during treatment; they are signs of the efficacy of the treatment. If in
doubt consult your doctor or dermatologist (scab, erythema, skin exfoliation, cutaneous haemorrhage,
headache, skin oedema, paresthesia, pruritis, burning sensation on the skin, feeling of heat, swelling.
The FLUXMEDICARE® V2 system must be used with a transparent occlusive dressing (not supplied with the
FLUXMEDICARE® V2 system). This should carry the CE marking For contraindications and adverse reactions
please refer to the instructions for use of this medical device.
The treatment should only be carried out by an authorised medical professional trained in photodynamic
therapy.