2020 Edge Hydrafacial MD Elite

Introduction

Congratulations on your purchase of the HydraFacial MD™ Elite™ System. You can have the utmost confidence in this leading edge

system designed in the USA by Edge Systems LLC. The HydraFacial System is a modular system which 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 offices, 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).

• Superficial 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, inflammatory 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, unidentified 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 orifice, such as over the eyelids. Eyes should be closed during the procedure

and covered with protective eyewear. 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 MD™ Elite™ is a Class IIa

medical device in the EEA; GMDN Code 11177.

System Specifications:

• Unit Size: 122 cm/48 in (H) x 46 cm/18 in (W) x 41 cm/16 in (D)

• Unit Weight: 39 kg (85 lbs)

• Electrical:

220 –240VAC, 50/60Hz, 8A 70290-03-01

100 –120VAC, 50/60Hz, 8A 70143-03-0

2020 Edge Hydrafacial MD Elite - Sale

Technical Specifications

Parameter Specification 220–240 VAC Specification 110–120 VAC

70290-03-01 70143-03-01

Voltage 220–240 VAC, 50/60 Hz, 8A 100–120 VAC, 50/60 Hz, 8A

Power Consumption 142 watts, maximum 142 watts, maximum

Mode of Operation Continuous Continuous

Audio Volume Under 70 dB Sound Pressure Level at 1 meter Under 70 dB Sound Pressure Level at 1 meter

Visual Indicators LCD display with system messages LCD display with system messages

Instrument Maker/Model Edge Systems LLC / HydraFacial MD Elite Edge Systems LLC / HydraFacial MD Elite

Dimensions 122 cm/48 in (H) x 46 cm/18 in (W) x 41 cm/16 in (D) 122 cm/48 in (H) x 46 cm/18 in (W) x 41 cm/16 in (D)

Weight 39 kg (85 lbs) 39 kg (85 lbs)

Operating Altitude Maximum of 2000 m Maximum of 2000 m

System Controls Touchscreen monitor, buttons, switches Touchscreen monitor, buttons, switches

Interconnects Custom cables Custom cables

Ingress of Fluids Not protected against the ingress of fluid. IPX0 Not protected against the ingress of fluid. IPX0

Flammability Equipment not suitable for use in the presence of flammable

anesthetic mixture with air or with oxygen or with nitrous oxide.

Equipment not suitable for use in the presence of flammable

anesthetic mixture with air or with oxygen or with nitrous oxide.

Electrical Conformity This medical equipment has passed all required testing for

electric shock, fire and mechanical hazards in accordance

with IEC 60601–1, IEC/EN 60601–1.

This medical equipment has passed all required testing for

electric shock, fire and mechanical hazards in accordance with

IEC 60601–1, IEC/EN 60601–1.

Electrical Shock Protection – Classification Class I Class I

Electrical Shock Protection – Degree Type BF Equipment Type BF Equipment

Product Life The Console is a non-sterile, durable good. The System

warranty runs for a period of one (1) year from the date of

installation of the System to the original Customer.

The Console is a non-sterile, durable good. The System

warranty runs for a period of one (1) year from the date of

installation of the System to the original Customer.

Applied Part The Handpiece is the client applied part The Handpiece is the client applied part

Separation From Power Mains Power switch on rear panel provides full separation from

power mains.

Power switch on rear panel provides full separation from

power mains.

Fuse Slow-blow fuse. 250V 8A Slow-blow fuse. 250V 8A

Environmental Conditions

Parameter Specification

For Shipping & Storage

Temperature: Normal (–20o to 60o C)

Relative Humidity: 10—90% RH

Atmospheric Pressure: 500—1060 hPa

Operating Conditions Temperature: Normal (10o to 40o C)

Relative Humidity: 30—75% RH