mychway HF-11M1 User manual

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Warning
Dear users:
Thanks for choosing our company’s product, in order to fully make use of the products, we
sincerely suggest follow:
◆◆Please read the instruction in detail and keep it well for further reading and consulting.
◆◆Please follow the instruction to fit and operate the machine correctly.
◆◆Please do not remove and change any accessories of the machine.
◆◆It forbids others others to open and remove the mainframe except the authorized people in
the company.
◆◆It forbids others to change and maintain the machine except the professional people.
◆◆Please contact us if there is any trouble during operation.
After Sale service
◆We offer ONE YEAR warranty. Within warranty period, all exchanges or replacement due to
defects are free. (Buyer is responsible for shipping charges).
If the machine is over warranty, please also do not hesitate to contact us. we will assure you of
our best service all the time.
◆How to contact us?
Phone:[phone]
Tel: [phone]
Email: [e-mail]
This product does not belong to medical,please don’t use for disease treatment!

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Table of Contents:
1. Introduction to Manual ................................................................................................... 4
1.1 Purpose .................................................................................................................... 4
1.2 Conventions ............................................................................................................. 4
2. Medical Safety ................................................................................................................ 4
2.1. Indications for Use ............................................................................................. 4
2.2. Contraindications ............................................................................................... 5
2.3. Precautions ........................................................................................................ 5
2.4. Patient Safety...................................................................................................... 5
2.5. Potential Side Effects.......................................................................................... 6
2.6. Complaints and Adverse Events......................................................................... 6
3. System Overview............................................................................................................. 6
3.1. System Description............................................................................................ 6
3.2. System Components and Features.................................................................... 7
4. System Safety................................................................................................................. 8
4.1. Electrical and Fire Safety................................................................................... 8
4.2. Equipment Use and Care.................................................................................. 9
5. Safety Up for First-Time Use.......................................................................................... 10
5.1. Unpacking......................................................................................................... 10
5.2. Physical Environment........................................................................................ 10
5.3. Identifying and Connecting Transducers .......................................................... 10
5.4. Connecting Components................................................................................... 10
6. Treatment Guidelines .................................................................................................... 11
6.1. Install control unit and handpiece with transducer .......................................... 11
6.2. Treatment Guideline ......................................................................................... 12
7. Andorid APP ................................................................................................................. 12
7.1. Connecting Bluetooth ....................................................................................... 12
7.2. Operation on APP ............................................................................................. 13
8. Specification .................................................................................................................. 13
9. Package Listing ................................................................................................................ 14
10. Cleaning and Care .......................................................................................................... 14
10.1. Cleaning the Transducer and Handpiece.......................................................... 14
10.2. General Care of the System ............................................................................. 14

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1. Introduction to Manual
1.1 Purpose
This instructions for use manual provides a description of the system components, its
controls and displays, instructions for its operation, and other equipment information
important to the user
Warning: Do Not operate this machine before reading this manual thoroughly. In
addition to this manual,additional clinical training may be available by the company
or your local distributor.
For more information on training available please contact your local representative.
1.2 Conventions
Note: Notes designate information of special interest.
Caution: Cautions alert the user to precautionary steps necessary to properly
operate the system.Failure to observe these cautions may void the warranty
Warning: Warnings alert the user to information that is of the highest importance
and vital to the safety of the patient and user
All procedures are broken down by numbered steps.Steps must be completed in the sequence
they are presented
Bulleted lists indicate general information about a particular function or procedure.They do not
imply a sequential procedure.
Control names are spelled as they are on the system,and they appear in Bold text
2. Medical Safety
2.1. Indications for Use
The SMART HIFU FACE LIFTING system is indicated for use as a non-invasive
dermatological aesthetic treatment to:
Lift the eyebrow
Lift lax tissue (beneath the chin) and neck tissue

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2.2. Contraindications
The SMART HIFU FACE LIFTING system is contraindicated for use in patients with:
Open wounds or lesions on the face and/or neck
Severe or cystic acne on the face and/or neck
2.3. Precautions
The SMART HIFU FACE LIFTING system has not been evaluated for use over
various materials. Therefore, treatment is not recommended directly over those
areas with any of the following:
Mechanical implants
Dermal fillers
Implanted electrical devices in the face and/or neck
Metal stents in the face and/or neck area
Treatment energy is not recommended for use directly on an existing keloid.
The SMART HIFU FACE LIFTING system has not been evaluated for use in patients on an
anticoagulant treatment plan
It is recommended that the following areas should be avoided during treatment:
Thyroid gland,thyroid cartilage and trachea
Major vessels
The SMART HIFU FACE LIFTING system has not been evaluated for use in the following
patient populations:
Pregnant or breast feeding women
Children
Those with the following disease states
A hemorrhagic disorder or hemostatic dysfunction
An active systemic or local skin disease that may alter wound healing
Herpes simplex
Autoimmune disease
Diabetes
Bell’s palsy
2.4. Patient Safety
Warning: SMART HIFU FACE LIFTING system should not be used on a patent’s
eyes or in

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a location or technique where ultrasound energy can reach the eye
Warning: Use this system only if you are trained and qualified to do so.
Warning: If any problems occur during system operation, ask immediate
action(s): lift the transducer off the patent’s skin, press the STOP button to
completely halt system operation.
2.5. Potential Side Effects
Side effects reported in the clinical evaluation of the SMART HIFU FACE
LIFTING system were mild and transient in nature.These were limited to:
Erythema (redness): The treated area may exhibit erythema immediately following
Treatment. This typically resolves within a few hours of treatment.
Edema (swelling)rythema (redness): The treated area may exhibit erythema
immediately following Treatment. This typically resolves within a few hours of
treatment.
Pain: Momentary discomfort may be experienced during the procedure while
energy is being deposited. Post procedure discomfort or tenderness to the touch is
also possible.
Bruising: Mild bruising, which is caused by damage to soft tissue blood vessels,
may occur occasionally and typically resolves within a few days of treatment.
Nerve Effects:
Transient local muscle weakness may result after treatment due to
inflammation of a motor nerve.
Transient numbness may result after treatment due to inflammation of a
Sensory nerve.
Transient pain, paresthesia and/or tingling may be experienced
No permanent injuries to facial nerves have been reported
Scarring: The possibility for scar formation ( which may respond to medical care)
May exist if incorrect treatment technique is used
2.6. Complaints and Adverse Events
No serious adverse events were observed during the clinical study evaluation of the
SMART HIFU FACE LIFTING system
3. System Overview
3.1 System Description
HiFU beauty system uses an advanced new high-intensity focused ultrasound
technology(HiFU for short). The machine will release highly concentrated focus
sonic energy which can directly penetrate into the skin and deep SMAS facial skin

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tissue that can stimulate and renew skin's collagen and thus tighten the skin and
remove wrinkles. It successfully achieves a quite good result of skin tightening and
face lifting without any help of invasive surgeries.
3.2 System Components and Features
3.2.1 Control Unit &Handpiece
A. Control unit
B. Handpiece
C. Power supply socket
D. ON/OFF button
E. Handpiece connecting
socket
Fig 1.0 control unit
Output button: S/P control button to
control start or pause
working
The rest line: how many shots remaining for
working
The total line: default working shots
Cartridge: transducer number
E: energy ,range from 0.2J, 0.4J, 0.6J,0.8J, to
1.0J five mode
L: Length from 5mm,10mm,15mm,20mm to
25mm five modes
Fig 2.0 Handpiece

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3.2.2 Transducers
Fig 3.0 transducers
The types of transducers reflect variations in frequencies and treatment depths
as following shown
Table1.0
3.2.3 Essential Accessories
Other essential components provided for operation of the SMART HIFU FACE
LIFTING system are the power cord that connects the system to an AC power
outlet, Ultrasound gel to facilitate transmission of the acoustic energy is also
required but is not provided as part of the system.
4. System Safety
The following precautions and warnings must be reviewed and observed:
4.1. Electrical and Fire Safety
Warning: To avoid risk of electric shock, always inspect the transducer,
handpiece and cable before use. Do not use a damaged cable or a transducer
that has been damaged or is leaking fluid.
The is system is intended for indoor, dry location use. Avoid liquid spills and splashes.
Keep coupling gel away from the handpiece-transducer connections.
The system comes with a three-conductor AC power cord and plug. Use a properly
TRANSDUCER TYPE
TREAT FREQUENCY
TREAT DEPTH
DS 4 –4.5
4 MHz
4.5 mm
DS 7 –3.0
7 MHz
3.0 mm
DS 10 –1.5
10 MHz
1.5 mm

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grounded outlet and always plug the system directly into the outlet. Never remove the
ground conductor or compromise the ground conductor via any AC adapter plugs or
extension cords.
Disconnect the power cord from the outlet by pulling on the plug not the cord.
Turn off the AC power switch and disconnect the AC power supply before cleaning the
control unit.
Do not remove the covers on the control unit or handpiece; the control unit contains
hazardous voltages. The system contains no user-serviceable components. If the system
requires service, contact mychway, Inc.
No modification of this equipment is allowed.
The system should not be used near flammable gases or anesthetics. Fire or explosion
can result. The system is not AP or APG rated.
Avoid restricting ventilation under and behind the hifu control unit. Maintain an open
space of at least 4 inches/ 10 cm around the control unit. If ventilation holes are
obstructed, the system could overheat.
The hifu control unit is rated as a Type BF patient applied part. It may provide a
connection between the patient and protective earth. This may present a hazard if the
patient becomes connected to other equipment with excessive electrical current
leakage.
Do not touch the handpiece electrical contacts and patient simultaneously.
To avoid a burn hazard, remove the transducer from the patient before performing HF
electrosurgical procedures.
4.2. Equipment Use and Care
Caution: Failure to observe these precautions may void the warranty.
The sytem handpiece connectors must be kept clean and dry. Do not use the
transducer if the connectors have been immersed in liquid. See the instructions for
cleaning the transducer.
Every effort has been made to make the transducers as rugged as possible; however,
they may be permanently damaged if dropped onto a hard surface or if the
membrane is punctured. Transducers damaged in this manner are not covered by the
warranty.

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The system has no user-serviceable components. Do not attempt to open the control
unit enclosure or transducers. Contact mychway, Inc. if service is required.
5. Setting Up for First-Time Use
5.1. Unpacking
The control unit and handpiece are shipped together in one container.
Transducers are packaged and shipped separately from the control unit and
handpiece, in ready-to-use, non-sterile pouches. Transducer gel is not packaged
and shipped due to logistic reasons,it can be purchased on location
5.2. Physical Environment
System Base
The system is portable and don’t need to be placed on a cart or counter,
handpiece and power cord provided.
5.3. Identifying and Connecting Transducers
5.3.1 Transducers connecting/disconnecting, please follow
the Fig 4.0 and Fig 5.0
Transducers are identified by the label on the top of the transducer which
includes the name of the transducer, treatment frequency
Fig 4.0 connecting

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Fig 5.0 disconnecting
5.3.2 The treatment guidelines on the handpiece interface will
display the recommended transducer to utilize
Remove the transducer indicated from its protective pouch. To connect
the transducer, slide the transducer into the handpiece, when the
transducer is fully seated you will hear a tone indicating that it has
been correctly inserted.
5.3.3 Testing
Caution: the control unit and transducer are needed to be test
before first-time using
Step1: connecting transducer and handpiece with control unit
Step 2: put ultrasound gel on the window of the transducer
Step 3: set energy and length,press start/pause button
Result: the system work well if ultrasound gel move even
splashing,if not,please contact mychway.,Inc.
6. Treatment Guidelines.
6.1 Install control unit and handpiece with transducer
i.Connect the power, switch on the machine

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ii. Install the probe into the handle
iii. You will see the handle screen shows “E”means Energy “L”
means length. Set the energy and length according patient feeling.
6.2 Treatment Guideline.
Table 2.0
7. Andorid APP
Caution:The andorid mobile phone or andorid pad need download
mobile phone or pad need with bluetooth function
7.1 Connecting Bluetooth
7.1.1 Press the length set key for several seconds, bluetooth icon will
shown on handle screen
7.1.2 Open the APP, turn on bluethooth, find”Smart HIFU”, click to connect it.

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then the handle screen will show a Bluetooth sign and you phone
will change to fig 5.0
Fig 5.0
7.2 Operation on APP
Detail Energy, length and treatment areas and lines shown on the app images, just
follow the guideline to use this system with recommendation table 2.0
8. Specification
Input: AC100v-240v
Power: 100W
Energy: 0.2J, 0.4J, 0.6J,0.8J,1.0J five mode
Length: 5mm,10mm,15mm,20mm,25mm five mode
Shots: 2500shots each head

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9. Package Listing
Main machine 1PCS
Focused ultrasonic handle 1PCS
Transducer DS-4.5 1PCS
Transducer DS-3.0 1PCS
Transducer DS-1.5 1PCS
Power cord 1PCS
10 Cleaning and Care
`10.1. Cleaning the Transducer and Handpiece
Note: Transducers are packaged and shipped non-sterile and ready to use.
Because the transducer will come in contact with the skin of a patient, the
standard practice for cleaning and low level disinfection of transducers between
patients is to gently but thoroughly wipe the transducers with a standard 70%
isopropyl alcohol prep pad. A Cavicide wipe followed by wiping with 70% isopropyl
alcohol may be used for additional disinfection if desired. One may also use a
standard 70% isopropyl alcohol prep pad to gently wipe the handpiece and cable.
Neither the transducers nor the handpiece should be submerged in liquid. Place
the transducer back into its original packaging between uses.
Warning: Use only this procedure for cleaning. Do not use acetone or other
solvents as this can damage the transducer.
10.2. General Care of the System
To get the best possible performance, treat the equipment carefully by adhering to
the following guidelines:
1. Inspect the handpiece and connectors regularly for any problems.
2. Stop/ Pause working before changing transducers to ensure proper
identification of transducers and to prolong the life of the system.
3. Do not drop the handpiece or transducers on the floor or other hard surfaces.
This can cause permanent damage.
4. Do not twist or pull the transducer cables. This could cause damage to internal
wires and connections.

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5. Use ultrasonic/ultrasound gel only. Other lubricants or lotions, particularly
mineral oil, could eventually damage transducers or cables.
6. Do not use acoustic standoff pads or any objects between the transducer and
patient.
7. Apply ultrasound gel only to the window of the transducer and wipe it from
the transducer after completing a treatment. Avoid getting the gel on
the handpiece or control unit.
8. Transducers should be cleaned between procedures. See cleaning procedure
information immediately preceding this subsection.
9. Keep new transducers in sealed pouches until ready for use.
10. Take care to store transducers in a safe and secure location to prevent damage
in between usage.
11. Do not hold the handpiece in a manner that can damage the chord or strain
relief while removing or inserting transducers.
Caution: Always check the expiration date on the transducer before using.
Expired transducers should not be used.