hydrafacial Syndeo - Introduction

4
User GuideHYDRAFACIAL Syndeo
™
1900104-B
en
Introduction
Congratulations on your purchase of the HydraFacial Syndeo
™
System! You can have the utmost condence in this leading edge
system designed in the USA by HydraFacial, LLC. The HydraFacial System is a modular system that may include other modes of
operation not available in the EEA. Separate User Guides are provided for all optional modalities.
The System is intended to be used in clinics, hospitals, doctor’s ofces, and aesthetic practices by trained and licensed practitioners,
such as dermatologists, facial plastic surgeons, physicians, and aesthetic professionals – in accordance with their licensing scope
and applicable national/local requirements.
Intended Use
The System is intended to abrade (exfoliate) the upper layers of the skin.
Indication (related to the use of the device in the European Economic Area (EEA):
• Mild to moderate acne, i.e. acne vulgaris, comedonal acne (blackheads and whiteheads).
• Supercial acne scarring.
Contraindications
It is intended for external use on intact skin only, subject to the following contraindications and warnings:
• Do not use over active acne, such as severe, inammatory acne.
• Do not use over active infection or open wounds (e.g., herpes simplex, excoriations, or open acne cysts).
• Do not use on client with autoimmune or communicable disease.
• Do not use on client with cold sores or fever blisters without pre-medication.
• Do not use over abnormal, unidentied facial growth or mark.
Side Effects
Client may experience temporary irritation, tightness, or redness at the treatment area. This usually dissipates within 72 hours
depending on skin sensitivity.
Warnings
• Not recommended for severe acne scarring.
• If the skin becomes irritated beyond normal, discontinue the treatment and seek medical advice.
• Do not use within the orbital area or over any body orice, such as over the eyelids. It is recommended to have the eyes closed
during the procedure. Sterile eye rinse solution should be available in case products accidentally get in the eyes.
• This System is not intended to be used on infants, children, pregnant or lactating women because it has not been evaluated for this
group of users.
• The above have been assessed and supported by clinical evaluation in accordance to Medical Device Directive 93/42/EEC
Annex X. The device complies with the applicable Essential Requirements in Annex I. The HydraFacial Syndeo
™
is a Class IIa
medical device in the EEA; GMDN Code 11177.
System Specications:
• Unit Size: 117 cm / 46 in (H) x 50.8 cm / 20 in (W) x 45.8 cm /18 in (D)
• Unit Weight: 30 kg (65 lbs)
• Electrical:
220 –240VAC, 50/60Hz, nominal 2A, 8A max
7000079
100 –120VAC, 50/60Hz, nominal 2A, 8A max
7000078