Purpose Of Use - DERMAPEN 4 Handbuch

1 - INTRODUCTION

1.1 - Purpose of Use

Dermapen 4™ is an Digital Automated MicroNeedling system that creates fractional puncture
channels into the skin. The e ect promotes natural collagen and elastin production, whilst
preserving epidermal integrity.
Dermapen 4™ may assist with the infusion of active ingredients, skin tightening, lifting
and rejuvenation. Other indications suitable for treatment include post-acne scars, fi ne lines,
wrinkles, enlarged pores and stretch marks. As part of combination therapies, alopecia may
also be treated.
Dermapen 4™ works to activate and facilitate the body's own healing and regenerative cascade.
1.2 - User Acknowledgement
• It is the responsibility of the user to carefully read all information presented in this manual
before using the Dermapen 4™. This includes warranty information.
• It is the responsibility of the user/purchaser to be aware of local laws and regional
restrictions for microneedling.
• It is the responsibility of the user to obtain appropriate insurance cover, if applicable.
• A consultation with the patient to establish medical history, consent, risk assessment, pre-
post recommendations and skin preparations should have taken place before commencing
treatment.
• Only physicians or other qualifi ed healthcare professionals should operate the Dermapen 4™
to a depth over 1.0mm. A 'physician or other qualifi ed health care professional' is an individual
who is qualifi ed by protocol education, training, licensure/regulation (when applicable) and
facility privileging (when applicable) who performs a professional service within his/her
scope of practice and independently reports that professional service.
1.3 – Usage Environments
Dermapen 4™ is suitable for use in the following environments:
• Qualifi ed Physician or Health Care/Medical Professional (Dermapen 4™ Model 4MD)
• Qualifi ed Clinical/Aesthetic Professional (Dermapen 4™ Model 4PRO)
During a professional procedure, the Patient usually reclines on a bed or chair. The Operator
operates the Dermapen 4™ using one hand, while gently holding the Patient's skin taut with
the other hand, utilising full sterile procedures and DermapenWorld's recommended protocol
products.
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