Alma Lasers Accent xl, Operator'S Manual

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Clinical Guide
A.1. Introduction
This clinical guide is provided to aid professionals in the use of the Accent XL
system. It adds to or reinforces information presented in the operator's manual
concerning instructions for use, precautions and warnings necessary to reduce the
risk of injury. All operators must read the entire operator's manual before reviewing
this appendix and before operating the system.
A.2. Training Requirements
The Accent XL system is designed to be operated only by personnel properly
trained in its handling and use. All personnel who operate the system must read the
operator’s manual. This includes physicians, nurses, technical staff or other
professional staff members.
Alma Lasers provides in-service training for the Accent XL system. At the end of
this in-service training, personnel are considered trained for the operation of the
Accent XL system.
The physician is responsible for contacting the local licensing agencies to determine
any credentials required by law for clinical use and operation of the device.
A.3. Intended Use and Indications
The radio-frequency (RF) Accent system is intended for use in dermatologic and
general surgical procedures for non-invasive treatment of wrinkles and rhytids.
A.4. Contraindications
•
History of any skin malignancy
•
Chronic skin conditions / irritated skin (i.e., Urticaria)
•
History of cancer
•
Pregnancy (including IVF)
•
Active collagen or vascular disease
•
High blood pressure
•
Phlebitis and blood-clotting (hematology-related)
•
Recent (less than one year) use of Isotretinoin (Accutane)
A-2 Accent XL
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Operator's Manual