Aesthetic Technology Limited
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PL-027 (Rev 7)
PL-027 (Rev 7)
The Dermalux® Flex MD device has NOT been tested on pregnant women and therefore
the risk to the foetus or pregnant woman is unknown. Administration of the treatment during
pregnancy would strictly be at the users or practitioners discretion.
For further Information about Contraindications please refer to the Dermalux Consultation
Guide (PL-011, available at learn.dermaluxled.com).
Clients who present with any of the following medical conditions may be treated with
caution and must be closely monitored.
Eye disease and conditions including Glaucoma, Cataracts, recent laser eye surgery
or Light Induced Migraines.
There are no known allergic reactions to the materials used for the manufacture of this
device, should reaction occur please seek medical advice and report as per Section 14.
Immediately after Flex MD treatment:
• Skin may feel warm and may appear red, due to the increased blood circulation
in the treated area. Skin should return to normal within 1 to 2 hours.
• Temporary headaches immediately following the LED treatment (very rare).
• Headaches can be treated with an appropriate pain killer and rehydration.
Should injury occur as a result of using this device please seek medical advice and report
as per Section 14.
In the unlikely event of a product fault or an adverse response to the Dermalux® Flex MD
treatment, please report the issue to Aesthetic Technology Ltd or your local Dermalux
representative as soon as possible. For all adverse reactions please complete form QOP-82-05-F1
following instructions provided with the form (available at learn.dermaluxled.com).
• A malfunction or deterioration in the characteristics or performance of the device.
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A malfunction or deterioration should be understood as a failure of the Dermalux®
device to perform in accordance with its intended purpose as specified in the User
guide.
• An adverse reaction or unanticipated side effect.
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An adverse reaction is an incident which causes, or has the potential to cause,
unexpected or unwanted effects involving the safety of persons receiving/or
having received a Dermalux® treatment or users of the Dermalux® LED system.
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An unanticipated side effect is one that exceeds the known side effects or is not
listed as a potential side effect in the Dermalux® TM User guide (anticipated side
effects)
• Use the correct section of the form to report;
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A malfunction or deterioration of the device
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An adverse reaction or unanticipated side effect
Examples of reportable events include: