hydrafacial MD Elite User manual

P/N 1900036-A
Rev. 2/18/2020
HydraFacial MD™Elite™
User Guide

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User Guide User GuideHYDRAFACIAL MD™Elite™HYDRAFACIAL MD™Elite™
EN EN
Copyright © 2020 Edge Systems LLC. All rights reserved.
Terms and Conditions of Use
HydraFacial™, HydraFacial MD™, Vortex-Fusion™, HydroPeel™, Britenol™, HydraFacial MD CTGF™, UV Smart™, and My Life,
My Time, My Skin™are trademarks of Edge Systems LLC that are registered in the United States. This product and its use are covered
by one or more U.S. and International patents. Patent info: hydrafacialco.com/patents. These intellectual property rights (IPR’s) remain
the exclusive property of Edge Systems LLC or its licensors.
Contents
Before You Start
4 Introduction
5 Technical Specications
5 Environmental Conditions
6 Safety Information
Getting Started
9 Unpacking
10 System Components
12 Set–Up
Operating Instructions
14 On, Off, and Standby/Sleep Modes
15 Touchscreen
17 Perform Treatment
Cleaning and Maintenance
17 Manifold and Tubing
18 HydraFacial™Handpiece
19 Waste Canister
19 Touchscreen
19 Removable Front Door
19 Skin Imaging Camera (Sold separately)
20 Troubleshooting
21 Limited Warranty
Contact Info
Edge Systems LLC
2277 Redondo Ave.
Signal Hill, CA 90755 USA
[phone] •[phone]
[e-mail]
hydrafacial.com
E C Rep Ltd
5 Fitzwilliam Square East,
Dublin 2, D02 R744, Ireland
Tel: [phone]
Email:[e-mail]
Responsible Person in the United Kingdom
E C Rep Ltd
Healthcare Education Centre,
Portland Street, Southport, PR8 1HU, UK
Tel: [phone]
Email:[e-mail]
2460

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User Guide User GuideHYDRAFACIAL MD™Elite™HYDRAFACIAL MD™Elite™
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Introduction
Congratulations on your purchase of the HydraFacial MD™Elite™ System. You can have the utmost condence 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 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. 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 Specications:
•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 70143-03-01
Technical Specications
Parameter Specication 220–240 VAC Specication 110 –12 0 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 uid. IPX0 Not protected against the ingress of uid. IPX0
Flammability Equipment not suitable for use in the presence of ammable
anesthetic mixture with air or with oxygen or with nitrous oxide.
Equipment not suitable for use in the presence of ammable
anesthetic mixture with air or with oxygen or with nitrous oxide.
Electrical Conformity This medical equipment has passed all required testing for
electric shock, re and mechanical hazards in accordance
with IEC 60601–1, IEC/EN 60601–1.
This medical equipment has passed all required testing for
electric shock, re and mechanical hazards in accordance with
IEC 60601–1, IEC/EN 60601–1.
Electrical Shock Protection – Classication 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 Specication
For Shipping & Storage
Temperature: Normal (–20 to 60 C)
Relative Humidity: 10—90% RH
Atmospheric Pressure: 500—1060 hPa
Operating Conditions Temperature: Normal (10 to 40 C)
Relative Humidity: 30—75% RH

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Product Marking Symbols
Symbol Description
Attention: Refer to accompanying documentation.
Separate collection for electronic.
Type BF Applied Part. Debrillation proof.
Direct Current
Alternating Current
ON (Power)
OFF (Power)
STANDBY (Power)
Consult Instructions For Use
Fuse
Pushing Prohibited
Certied by CSA Group
Connect to supply mains with protective earth (ground)
Keep Dry
Caution and Marking Symbols
Symbol Description
Calls attention to a procedure, practice, or condition that
could possibly cause bodily injury or death.
Calls attention to a procedure, practice, or condition that
could possibly cause damage to equipment or permanent loss
of data.
Do Not Re-use
Manufactured By
Date of Manufacture
2460
Conformité Européenne
Catalogue Number
Serial Number
Lot Number
European Representative
Medical Device
Unique Device Identier
Safety Information
Safety Guidelines
1. Ensure that all operators of the HydraFacial MD™Elite™System are trained and licensed as required by local/national
regulations. Do not operate the unit before being trained. For any questions regarding training, contact Edge Systems LLC or your
local distributor.
2. Be sure to read the User Guide thoroughly before setting up the System. If you experience mechanical and/or electrical difculties
with your unit, contact your local distributor.
3. Always do a client consultation to determine if the client is a candidate for the procedure. Follow contraindications and warnings
as pre-determination for procedure.
4. Always use clean, unused tips for each procedure. Keep tips in original packaging until ready to use.
Reusing tips could result in skin infection.
5. Do not use contaminated skin solutions.
Reusing contaminated skin solution could result in skin infection, and will void all warranties. Partially used skin solution
bottles must be capped and stored in accordance with instructions on product label.It is recommended not to use skin solutions
that exceed the "Best Used By" date. If you observe any abnormality with your products, please contact Edge Systems LLC or your
local distributor.
6. Removing contact lenses prior to procedure is recommended.
7. The client should have a minimum sunscreen SPF 30 applied after the procedure and should use sunscreen on an ongoing basis.
8. Each client’s skin conditions and sensitivity are different. Always begin treatment conservatively. Do a sensitivity test on the neck
by the earlobe rst, and increase or decrease the vacuum level as appropriate. Lower vacuum level is recommended for thin,
fragile skin. Skin conditions requiring more aggressive vacuum level are at operator’s discretion. Follow recommended protocols
and cautiously consider skin types.
9. Empty the waste canister after each service according to your waste handling protocol and local/national regulations. Follow
the System cleaning instructions in this guide to clean your System and handpiece.
10. Keep the System in accordance to recommended environmental conditions. Liquid should only be suctioned through
the HydraFacial handpiece.
11. Always use solution when performing abrasion. Performing the treatment without skin solutions could result in discomfort to
the client.
12. The System is not spill proof. Avoid spillage of any liquid on the System.
13. The System is not intended to be used in conjunction with any other System, medicine or technology and should only be used
in accordance with these Instructions for Use.
14. Use of non-approved skin solutions will void the warranty and may clog the System.
15. Do not let the waste canister overll. If this happens, a built-in oat device will occlude the vacuum opening and skin solution
ow through the handpiece will cease.
Note: Always remove the waste canister before transporting the unit.
16. Do not attempt to lift the unit alone or move over uneven or damaged ooring.

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17. Wearing gloves is recommended when performing all treatments, system cleaning and preventive maintenance activities.
18. Device cannot be serviced or maintained while in use.
19. Unauthorized user modications will void warranty. Edge Systems LLC will not be responsible for any injuries sustained
due to unauthorized System modications or use of parts not specied by Edge Systems LLC. Systems returned to Edge Systems LLC
with unsafe modications will be returned to their original operating condition at the customer’s expense.
20. DO NOT suction liquids through the dry port located on the side of the unit. This will damage the System and void the
warranty.
21. Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in
improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are
operating normally.
22. If this System does cause interference, which can be determined by turning the System off and on, the interference can
be possibly corrected by one or more of the following measures:
•Relocate the System with respect to the receiver.
•Move the System away from the receiver.
•Plug the System into a different electrical outlet so that the System and receiver are on different branch circuits.
23. Use of accessories, transducers and cables other than those specied or provided by Edge Systems LLC could result in increased
electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.
Note: The emissions characteristics of this equipment make it suitable for use in industrial areas and hospitals (CISPR 11 Class A).
If it is used in a residential environment (for which CISPR 11 Class B is normally required), this equipment might not offer adequate
protection to radio-frequency communication services. The user might need to take mitigation measures, such as relocating or
reorienting the equipment.
Emissions Standard Test Method
EN 606061-1-2: 2015
IEC 60601-1-2:2014
CISPR 11:2015 +A1:2016
EN 61000-3-2:2014
EN 61000-3-3:2013
Immunity Standard Test Method
EN 60601-1-2:2015
IEC 60601-1-2:2014
IEC 61000-4-2:2008
IEC 61000-4-3:2010
IEC 61000-4-4:2012
IEC 61000-4-5:2014
IEC 61000-4-6:2013
IEC 61000-4-8:2009
IEC 61000-4-11:2004
ISO 7637-2
24. Portable RF communications equipment should be used no closer than 15 cm/6 in to any part of the HydraFacial
System, including cables specied by Edge Systems LLC. Otherwise, degradation of the performance of this equipment could
result.
25. To prevent electric shock, do not remove the instrument cover. There are no user serviceable parts inside. Routine
maintenance or cleaning of internal parts is not necessary. Avoid the use of cleaning agents or chemicals on the instrument. Some
chemicals may damage plastic parts or lettering. Any external cleaning should be done with a clean, dry or slightly damp cloth.
Unpacking
Inspect the Shipping Carton
Your System was shipped in a custom foam insulated box that has been tested to UPS standards. If the shipping carton is damaged,
inspect the contents for visible damage such as dents, scratches or any other obvious signs of damage. If the System is damaged,
notify Edge Systems LLC or your local distributor and they will assist you in the repair or replacement of your System.
Do not return your unit without rst contacting your distributor and receiving an RMA (Return Material Authorization) number.
Unpack the unit, accessories and all documents. Retain the original packaging in case you need to ship the System for any reason.
Verify that all appropriate items have been received.
The unit is large and heavy and should not be lifted alone.
Package Contents
•Console Unit
•Plastic Cartridge Handpiece Assembly
•Tool Holder
•Puncture Tool
•Waste Canister Assembly
•Cleaning Caps, 5-Pack
•HydraFacial Power Cord (Region Specic)

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System Components
Port for Waste Canister
(Rear of the Unit)
Accessory Rail
Dry Port
Coupling Fitting for
HydraFacial Handpiece
Manifold Buttons for
Solution Bottles
Pick-Up Tubes for
Skin Solution and
System Cleaning
Solution Bottles
Touchscreen
Illuminated
Power Switch
Side Panel:
USB Port
Toggle Switches
for Solutions
Removable
Acrylic Door
Wheels
(Front Wheels
with Brakes)
3.5 mm Jack Audio Cable
USB Type A Cable
DC Barrel Connector
(3.5mm)
AC Connector (Not Used)
VGA Cable
(Port can only be used to connect VGA
cable from inside HydraFacial Device
to the HydraFacial Device Monitor)
(Port can only be used to connect USB Type
A Cable from inside HydraFacial Device
to the HydraFacial Device Monitor)
Note: The ports and cables can only be used for connections as specied
and cannot be used for other types of connection.
USB 5V 1A
(Power only, no data)
Skin Imaging Camera Connector
(Not available in all countries)
USB with data (5V 500 mA)
For Backing up Skin Imagin Data
and/or Restoring Data.
Only install accessories
on two sides of handrail
Only use the back
of handrail to move
the device

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Set-Up
Tool Holder
1. Loosen thumbscrews rst.
2. Attach the tool holder, top rst onto the accessory rail.
3. Tighten the thumbscrews to lock the handpiece holder in place.
Waste Canister
1. Secure waste canister shelf to the back of the System.
2. Attach the waste canister lid and secure the clamps.
3. Insert the tube on the lid into the waste canister port on the back of the unit.
4. Make sure the waste canister sits securely on the ledge. Use a Phillips screwdriver to install the ledge.
Note: Always remove the waste canister before transporting the unit.
HydraFacial Handpiece
1. Connect the blue twist lock (Return Line) to the blue connector on the bottom of the handpiece and secure by twisting thumb tight.
Do not overtighten.
2. Connect the clear twist lock (Supply Line) to the cartridge and secure it by twisting the lock only thumb tight. To prevent the lock
from breaking, do not overtighten the twist lock.
3. Plug the small tube attached to the handpiece into coupling tting in the System.
4. Connect the large tube attached to the handpiece into the waste canister.
5. Insert the cartridge into the handpiece. Align the arrow on the cartridge with the unlock symbol on the handpiece.
Push rmly until it snaps into place, then twist the cartridge up until the arrow aligns with the lock symbol.
Note: If the cartridge is difcult to insert, drizzle a small amount of water into the cartridge to lubricate it, and try again.
6. To remove the cartridge and insert skin solution vials (sold separately), twist the cartridge until the arrow aligns with the unlock
symbol, then pull the cartridge straight out. Then insert the vial into the handpiece. Push rmly until it snaps into place.
Note: Keep all the toggle switches off while using vials.
7. Turn the ow control valve toward the “+” sign to increase the serum ow or towards the “–” sign to decrease the ow.
HydroPeel Tip
1. Align the HydroPeel tip and attach it to the handpiece.
Caution: Avoid dropping or damaging the disposable tip prior to treatment. Disposable tips suspected of being
damaged should be discarded and replaced. Damaged tips may cause scratches or discomfort to the client.
Single use only.
Skin Solution Bottles (Sold separately)
1. Open the front door. Remove the cap of the skin solution bottle and use the puncture tool to pierce the seal inside the bottle.
2. Press and hold each manifold button as you insert each bottle into the manifold, and then release the button.
Note: The Rinseaway™System Cleaning Solution should be installed in the manifold with the gray toggle switch labeled
“SYSTEM RINSE”.

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3. The toggle switches control which skin solution bottle is being used. When a switch is in the ON position, uid will be drawn
from that bottle. When switched to the OFF position, no uid will be drawn from the corresponding bottle.
Note: Always keep the “SYSTEM RINSE” toggle switch (gray) off while performing procedures.
Skin Imaging Camera (Not available in all countries)
1. Attach the tool holder, top rst, onto the accessory rail. Tighten the thumbscrews to lock the tool holder in place.
2. Insert the cable end connector from the camera into the port located on the right side of the unit. Push in and twist until
it is completely locked.
3. Place the camera on the tool holder when not in use.
On, Off, and Standby/Sleep Modes
Turn ON the System
1. Verify the switch on the power entry module located on the back of the unit is in the OFF ( O) position.
Connect the power cord to the power entry module and connect the plug into a grounded wall outlet.
2. Switch the power entry module switch to the ON ( I ) position.
3. The Illuminated Power Switch will light up blue.
4. Press the blue Illuminated Power Switch. The System should begin its boot up cycle at this point.
Standby/Sleep Mode
1. Press the Illuminated Power Switch and a “System Cleaning Reminder” will appear on the screen.
2. If you have not cleaned the skin solution stations, press NO and the System Cleaning Protocol Page will appear.
Note: You must clean the skin solution stations before you can turn the System off or switch to the standby mode. Always turn
to the Standby/Sleep mode at the end of each day.
3. If you have cleaned the skin solution stations, press YES and the System will go into standby mode.
Turn OFF the System
1. Follow the above steps to switch the System into Standby/Sleep Mode. Then switch the power entry module switch on the back
of the unit to the OFF position, and the System is completely shut off.
Touchscreen
This section shows how to operate the touchscreen and navigate the pages. The user interface is designed to be intuitve and
consistent on each page, therefore, only some pages will be shown below as an example. The touchscreen has been preset for
optimal performance with the HydraFacial program. Thus, you cannot and will not need to adjust the monitor.
1. Access each page by lightly tapping the buttons displayed with your ngertip, not ngernail. If the touchscreen does not respond,
verify that you have actually pressed on the button and did not miss it.
Note: There may be a slight delay when you press the touchscreen; do not press repeatedly if it does not respond immediately.
Navigating the System
Start-Up Page
Touch the button to goto the Home Page.
Home Page
•Access Protocols
•Access Optional Modalites
•Access System Cleaning instructions
•Return to Home Page
•Adjust Volume
•Access System Settings
•Access Patient Information
HydraFacial Protocol Menu
Select desired Protocol.

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Protocol Page
•Protocol Menu
•Next/Previous Step
•Turn On/Off Vacuum
•Adjust Vacuum
•Suggested Patterns
Pop-Up Windows
If you see a pop-up window, follow the on-screen instruction and press the appropriate
button.
Cleaning Your System
In-procedure cleaning: A pop-up window will prompt you to run a quick system-
cleaning. Press the "START" button to begin cleaning.
VACUUM CONTROLS
System Cleaning
Access the System Cleaning page from the Home Page and follow the steps indicated
on the screen. Use the Vacuum Control button to start the cleaning process.
Perform Treatment
Wearing gloves is recommended when performing all treatments.
1. Cleanse customer’s face.
2. Place a tip on handpiece.
3. Turn on the skin solution.
4. Place tip against skin to occlude and dab skin solution on face.
To exfoliate, do overlapping strokes from the center of face outwards.
Make two passes.
Manifold and Tubing
Wearing gloves is recommended when performing all cleaning and maintenance activities.
After Each Service
1. After each procedure, run the “System cleaning process”. Start by switching all the blue toggle switches down to the OFF
position, and switch only the gray toggle switch “SYSTEM RINSE” up to the ON position.
2. Make sure that the Rinseaway™System Cleaning Solution is properly installed.
3. Turn the ow control valve all the way over to the “+” sign and attach the cleaning cap to the handpiece.
Cleaning
cap
4. Make sure that the Rinseaway System Cleaning Solution is properly installed. Switch the toggle switch to “ON”.
Note: Only use HydraFacial Rinseaway System Cleaning Solution to properly clean the handpiece.
5. Turn the vacuum on and set to 26. Let the cleaning process run for 20–30 seconds.
6. When completed, be sure to switch the toggle switch to “OFF” and return the ow control to the recommended setting.
Weekly Cleaning
1. Use the Rinseaway solution on each individual skin solution station to prevent/remove any clogging. Follow the above instructions
to clean/ush your System.

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HydraFacial Handpiece
The HydraFacial™handpiece tubing chambers must be cleaned and disinfected using the cleaning brush.
1. Make sure ow control is fully open. Detach the handpiece from all tubing. Gently twist the knobs counter-clockwise to detach
each tube from the handpiece.
2. Insert the cleaning brush into the vacuum (smaller opening) on the face of the handpiece Push it in gently all the way, while
rotating in either direction. Repeat with the opening on the back with the blue twist lock connector.
Vacuum
opening
Face of the handpiece
Note: Barbicide is a recommended
disinfectant (follow Barbicide's
iInstructions for use). Isopropyl
alcoholis not suitable as a disinfectant.
3. Wash the brush bristles in soapy water between each handpiece opening insertion to clean off debris.
4. When the brush cleaning is completed, make sure all the blue toggle switches are in the 'OFF' position. Turn the grey 'SYSTEM
RINSE' toggle switch up to the 'ON' position and set the vacuum setting to 26. Press on the cleaning cap and ush through the
handpiece and tubing for 1 minute.
5. Use one Barbicide wipe to clean the entire outer surface of the Handpiece, removing all visible soil. Use a second Barbicide
wipe to thoroughly wet the surface of the Handpiece and ensure the Handpiece remains visibly wet for 2 minutes.
Waste Canister
After Each Service
1. Empty waste on the back of the unit. DO NOT let the waste canister ll above 450 mL.
Daily
1. Wash and wipe/spray germacide over waste canister and lid.
Note: Always remove the waste canister before transporting the unit.
Touchscreen
As Needed
The surface of touchscreen may be cleaned as needed to remove any residue or dust.
1. Apply window or glass cleaner on a non-scratching microber cloth and wipe the touchscreen. Do not apply the cleaner directly
on the touchscreen. Avoid getting liquids inside the touchscreen.
Note: Do not use any type of alcohol or strong solvent, as well as thinner, benzene, abrasive cleaners, or compressed air,
as it may damage the touchscreen surface.
Removable Front Door
As Needed
The surface of removable front door may be cleaned as needed.
1. Apply any plastic cleaner (available at your nearest hardware store, i.e., Novus Plastic Clean & Shine) and use a non-scratching
cloth or paper towel to wipe it clean. Do not use any type of alcohol or any strong solvent.
Skin Imaging Camera (Sold separately.)
1. Clean the chin rest with an alcohol wipe after each use.