hydrafacial Syndeo User manual

P/N 19 0 0104 - B
Rev. 02/22/2022
HydraFacial Syndeo™
User Guide

2
User GuideHYDRAFACIAL Syndeo™
1900104-B
en
Copyright © 2022 HydraFacial, LLC. All rights reserved.
Terms and Conditions of Use
HydraFacial™, Vortex-Fusion™, HydroPeel™are U.S. Registered trademarks, and many other referenced marks throughout this User
Guide. For a complete listing of all U.S. Registered trademarks, go to www.hydrafacial.com/patents/trademarks. 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 HydraFacial, LLC or its licensors.
Contact Info
HydraFacial, LLC
3600 E. Burnett St.
Long Beach, CA 90815 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:
Responsible Person Ltd.
Summit House, 4-5 Mitchell Street,
Edinburgh, EH6 7BD, UK
Tel: [phone]
Email: [e-mail]
1639

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User GuideHYDRAFACIAL Syndeo™
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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 Gesture Control Functions
18 Perform Treatment
Cleaning and Maintenance
19 Cleaning and Maintenance
20 Handpiece Cleaning
21 Manifold Cleaning
21 Touchscreen Cleaning
22 Troubleshooting
23 Limited Warranty

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User GuideHYDRAFACIAL Syndeo™
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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

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User GuideHYDRAFACIAL Syndeo™
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Technical Specications
Parameter Specication 220–240 VAC Specication 110 –12 0 VAC
7000079 7000078
Voltage 220–240 VAC, 50/60 Hz, nominal 2A, 8A max 100–120 VAC, 50/60 Hz, nominal 2A, 8A max
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 HydraFacial, LLC / HydraFacial Syndeo™HydraFacial, LLC / HydraFacial Syndeo™
Dimensions 117 cm / 46 in (H) x 50.8 cm / 20 in (W) x 45.8 cm /18 in (D) 117 cm / 46 in (H) x 50.8 cm / 20 in (W) x 45.8 cm /18 in (D)
Weight 30 kg (65 lbs) 30 kg (65 lbs)
Operating Altitude Maximum of 2000 m Maximum of 2000 m
System Controls Touchscreen monitor, buttons Touchscreen monitor, buttons
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 two (2) years 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 two (2) years 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 SGS
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
1639
Conformité Européenne
Catalogue Number
Serial Number
Lot Number
European Representative
Medical Device
Unique Device Identier
Safety Information

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User GuideHYDRAFACIAL Syndeo™
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Safety Guidelines
1. Ensure that all operators of the the HydraFacial Syndeo™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 The HydraFacial
Company 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. Verify any known allergies with the client. Perform a patch test if necessary.
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. Use only tips manufactured by HydraFacial, LLC.
6. Use only solutions and formulas authorized by HydraFacial, LLC.
7. 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 HydraFacial, LLC or your
local distributor.
8. Removing contact lenses prior to procedure is recommended.
9. The client should have a minimum sunscreen SPF 30 applied after the procedure and should use sunscreen on an ongoing basis.
10. 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 levels are at operator’s discretion. Follow recommended protocols and
cautiously consider skin types.
11. Empty the #Gunkie 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.
12. Keep the System in accordance to recommended environmental conditions. Liquid should only be suctioned through
the HydraFacial handpiece.
13. Always use solution when performing abrasion. Performing the treatment without skin solutions could result in discomfort to
the client.
14. The System is not spill proof. Avoid spillage of any liquid on the System.
15. 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.
16. Use of non-approved skin solutions will void the warranty and may clog the System.
17. Do not let the #Gunkie 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 #Gunkie waste canister before transporting the unit.

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User GuideHYDRAFACIAL Syndeo™
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18. Do not attempt to lift the unit alone or move over uneven or damaged ooring.
19. Wearing gloves is recommended when performing all treatments, system cleaning and preventive maintenance activities.
20. Device cannot be serviced or maintained while in use.
21. Unauthorized user modications will void the warranty. HydraFacial, LLC will not be responsible for any injuries
sustained due to unauthorized System modications or use of parts not specied by HydraFacial, LLC. Systems returned to
HydraFacial, LLC with unsafe modications will be returned to their original operating condition at the customer’s expense.
22. DO NOT suction liquids through the dry port located on the side of the unit. This will damage the System and void
the warranty.
23. 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.
24. 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.
25. Use of accessories, transducers, and cables other than those specied or provided by HydraFacial, 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
26. 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 HydraFacial, LLC. Otherwise, degradation of the performance of this equipment
could result.

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User GuideHYDRAFACIAL Syndeo™
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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 HydraFacial, 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
•Syndeo System
•Accessory Box
◦ Power cord
◦ #Gunkie waste canister
◦ Puncture tool
◦ Handpiece caps
•Handpiece Kit
◦ Black plastic handpiece
◦ Handpiece tubing
◦ Cleaning tools
•Lymphatic kit
◦ Facial lymphatic handpiece
◦ Body lymphatic handpieces
◦ Tubing
◦ Split Cup Tubing
27. 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.
28. Do not rest cups or any liquid containing vessels that could spill on the monitor or in the backpack.
29. The use of LightStim Elipsa™in conjunction with HydraFacial products and protocols is at the discretion of the esthetician. Products
that can cause irritation are recommended to be used after LightStim Elipsa™such as: Retin-A, benzoyl peroxide, harsh acids,
potential reactive forms of vitamin C and A, and products containing metals.
30. Do not locate machine in a position that blocks access to the rear power switch.
31. End of life disposal instructions: Do not dispose of this product with ordinary waste. Please refer to your local, state, or national
authorities for directions on how to comply with local electronic waste disposal requirements.

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User GuideHYDRAFACIAL Syndeo™
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System Components
Tray
Handpiece cradle
Manifold buttons
For solution bottles
Qr code camera
Gesture control
sensors
Facial lymphatic
cradle
Wheels
(front wheels
with brakes)
Pick-up tubes
For skin solution
and system
cleaning
solution bottles
Touchscreen