User manual

Derma-Frac
Micro Needling RF device

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 Table of Contents
WARNING........................................................................................................................................................ 3
Chapter 1 Introduction.................................................................................................................................4
1.1 Equipment Description............................................................................................................................. 4
1.1.1 Product Model................................................................................................................................4
1.1.2 Constitute of Equipment................................................................................................................ 4
1.2 Overview....................................................................................................................................................5
Chapter 2 Safety............................................................................................................................................. 5
2.1 Introduction...............................................................................................................................................5
2.2 The Operator............................................................................................................................................. 6
2.3 Electrical and Mechanical Safety.............................................................................................................. 7
2.4 Fire Hazards............................................................................................................................................... 7
Chapter 3 System Installation........................................................................................................................8
Chapter 4 Operating the System.................................................................................................................. 10
4.1 Turning the System On/Off.....................................................................................................................10
( Figure 4-1 )........................................................................................................................................ 10
4.2 Treatment Screen....................................................................................................................................10
Figure 4-2.............................................................................................................................................11
4.3 Derma-Frac Treatment Mode................................................................................................................. 11
Chapter 5 Treatment Procedures................................................................................................................. 12
Derma-Frac Treatment.......................................................................................................................... 12
5.1 Exclusion Criteria.....................................................................................................................................12
5.2 Possible Side Effects................................................................................................................................14
5.3 Pre-treatment..........................................................................................................................................14
5.4 Test Treatment........................................................................................................................................ 15
5.5 Treatment Procedure..............................................................................................................................15
5.6 Treatment Protocol................................................................................................................................. 17
5.7 Treatment Parameters............................................................................................................................17
5.8 Post Treatment Care............................................................................................................................... 17
5.9 Follow-Up................................................................................................................................................ 18
Treatment Conclusion........................................................................................................................... 18
Chapter 6 Maintenance................................................................................................................................ 18
Cleaning the System.............................................................................................................................. 19
Chapter 7 Troubleshooting........................................................................................................................... 20
Chapter 8 Technical Specifications............................................................................................................... 21
Chapter 9 Contact us..................................................................................................................................... 21

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WARNING
Please read the User Manual instructions carefully before installing or using the System to
become familiar with all safety requirements and operating procedures thereby prevent accidents,
injury and reduce the risk of damaging the machine

Chapter 1 Introduction

1.1 Equipment Description

Name of the system Derma-Frac micro needling RF System. The Derma-Frac system is a non
invasive medical aesthetic device intended for use in dermatologic and general surgical
procedures requiring:

 Ablation and resurfacing of the skin, using Derma-Frac fractional applicator

 Treatment of moderate to severe facial wrinkles and rhytides in Fitzpatrick skin types I- IV,
using non-needle applicator

Skin Rejuvenation with Derma-Frac system is a unique procedure which uses radio frequency
energy to deliver an effective but controlled ablative treatment.

The energies supplement each other to provide optimal treatment results with minimal risk of
side effects.

1.1.1 Product Model

Derma-Frac

1.1.2 Constitute of Equipment

Following two parts constitute therapy device

 Main console

 Treatment hand piece

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1.2 Overview

a: machine body

b: touch button

c : handle connector (detachable accessory )

d : microneedling rf handle (detachable accessory )

e: power button

Chapter 2 Safety

This chapter describes safety issues regarding the use and maintenance of the System,
with special emphasis on electrical safety.

Please carefully read this chapter and be familiar with all of its safety requirements and operating
procedures prior to operating the System

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2.1 Introduction
The System is designed for a safe and reliable treatment when used in accordance to proper
operating and maintenance procedures as outlined in this operating manual. Only trained and
qualified personnel, by an authorized trainer, can use the system and perform the treatments.
The operator and all other personnel operating or maintaining the System should be familiar with
all of the safety information provided in this manual. The primary objective should always be in
maximizing the safety of both the client and the treatment operator.

2.2 The Operator

 All operators MUST be familiar with the system controls and know how to shut down the
system in case of trouble

 Always be aware of the possible dangers of using the System and take proper precautions
as described in this manual.

 Do not touch the inner parts of the System. The System services and repairs must be
performed by qualified personnel only. Failure to do so will void all service agreements.

 RF used in this technology can cause injury if used improperly.

 High voltage is present inside the System, do not attempt to open the casing.

 Disconnect the System from the power supply before servicing (pull out the plug).

 Do not use the System unless all enclosure panels are properly in place.

 Do not abuse, sit or lean on the system

 Derma-Frac System should be kept out of the reach of Children

 Do not allow the Applicators to come in contact with metal elements this could damage the
electrodes

 A patient history should be completed prior to treatment to ensure no complications could

arise. It is important to verify client does not full under the exclusion criteria.

 The PATIENT should not come into contact with metal parts which are earthed or which
have an appreciable capacitance to earth (for example operating table supports, etc).

 The cables to the Applicators should be positioned in such a way that contact with the
PATIENT.

 For PATIENT with cardiac pacemakers or other active implants, a possible hazard exists
because interference with the action of the pacemakers may occur, or the pacemaker may
be damaged. In case of doubt, approved qualification advice should be obtained

 The patient should then be fully informed of the treatment protocol, expected results and

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 should sign informed consent form prior to beginning treatments.

 Only authorized person is allowed to stand near the system during the treatment.

 Stop the treatment in case of unexpected changes in client’s condition.

 Do not drop the Applicators. In case the Applicators were dropped, turn off the system
immediately.

 Don’t use the broken applicator and call to local service support.

 There are no user-serviceable parts inside the system. ONLY Sincoheren AUTHORIZED
PERSONNEL MAY SERVICE THE SYSTEM, ESPECIALLY INSIDE ITS CABINET.

 Keep the bodies of the applicators clean; pay particular attention to the RF electrodes of the
Viva Fractional applicator. Check the integrity of all components.

 Tip of the Viva Fractional applicator should be used per patient only Do not allow the
applicators to come in contact with hard materials that could damage the tips.

2.3 Electrical and Mechanical Safety

 Keep all covers and panels of the System closed. Removing the covers creates a safety
hazard.

 Keep your hands away from the applicators during the System start-up. Perform
maintenance procedures when the System is shut down and disconnected from power.

 Move the System slowly and carefully. The System weighs approximately 20kg and may
cause injury if proper care is not taken when moving it.

 The System is grounded through the grounding conductor in the power cord. This protective
grounding is essential for safe operation.

2.4 Fire Hazards

 Do not use the System in the presence of explosive or flammable materials.

 Do not use flammable substances when preparing the skin for treatment.

 If germicide swipes is used for cleaning and disinfecting the system, it must be allowed to
fully dry before the System can be used again.

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Chapter 3 System Installation

The system is designed for operation in a clinical environment and it may be easily transported
inside a protective carrying case.

The Med-Frac system is set up by doing the following:

1. Unpack the system.

2. Check the integrity of the system and all components.

3. Connect the Derma-Frac applicator to the system platform

4. Connect the power cable to the system cable connection port.

6. Plug the system's power cable into an appropriate electrical outlet.

7. Turn the system on

3.1 Equipment List

The System includes the following:

 System platform (Console Med-Frac).

 Handle Applicator. (detachable accessory)

 Power cord.

 Tips

3.2 Electrical Requirements

The System can automatically accommodate the most of the local mains voltage. Specifically,
the System can be energized of the mains voltage as follow:

Single phase 100/120/240V ~, 350W(MAX), 50/60Hz

3.3 Environmental Requirements

 Corrosive materials can damage electronic parts, ensure that the environment is free from
corrosive material.

 Metallic dust can damage electrical equipment

 For optimal operation, the System should be placed in a room with temperature between

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 10º- 35ºC (50º-95ºF) with a relative humidity of less than 80% and altitude up to 3000m

 For optimal storage, system should be stored in a place with temperature between -20 to
55°C (-13 to 131°F) with a relative humidity of 0-90 % @ 55°C non-condensing. For Optimal
transportation system should be transport under the temperature range between -10º- 60ºC
(14º-140ºF) with a relative humidity of less than 80% and altitude up to 15000m.

3.4 Connect the Applicators

1. Connect the applicator's cable connector to the system's connection port

2. To disconnect the applicator, turn the black ring counter-clockwise (in the direction of the
arrow) until it releases and then pull the connector out.
3. Put the applicator in its cradle

3.5 Connect/Disconnect a Tip to Derma-Frac Applicator

Refer to Figure A: to connect a tip to the applicator, hold it in the correct orientation – with the
embossed "T" facing the top of the applicator and aligned with the top of the applicator – and
push it onto the applicator's connection port until you feel it click.

To remove the tip from the applicator, switch it backwards and take off the tip.

Figure A

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Chapter 4 Operating the System
4.1 Turning the System On/Off

Before turning the System “ON”, verify that the power cord is connected to the inlet located on
the rear panel of the system and to the main power outlet.

Switch on the system by turning on the “ON/OFF” button located underneath the screen. The
ON/OFF button will be illuminated and within 50 seconds the Login Screen will be displayed on
the system's touch screen.

( Figure 4-1 )

4.2 Treatment Screen

The Treatment Screen is the system main screen (see Figure 4-2). Operator can control
treatment parameters, start and stop a treatment, and access Tools screen from this screen

In order to perform a treatment, operator should follow these steps:

1. Select the desired Applicator according to required treatment mode and area

2. Adjust treatment parameters

3. Initiate treatment

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 Figure 4-2

4.3 Derma-Frac Treatment Mode

Figure 4-2 presents the treatment parameters associated with Derma-Frac treatment. Below
please find explanation on the buttons on the screen:

Manual: Manual working mode by pressing the button to work

Auto: Auto working mode (the applicator works automatically without pressing the button)

Times: Current working shots

Time: Working time (default working time is 60mins )

Depth: Working depth of the tips 0.2mm to 3.5mm

Speed: 0.1s to 0.5s

Suction: 0-2

RF: 10W-150W

: Decreasing the parameters

: Increasing the parameters

F: Face areas including the forehead, eyes, cheek, nose,areas above the mouth, chin, nasolabial
folds, and the neck.

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B: Body areas. Please refer to the body areas with interface below:

Chapter 5 Treatment Procedures

Derma-Frac Treatment

The Derma-Frac system, using the Derma-Frac applicator, is designed for use in dermatological
procedures requiring ablation and resurfacing of the skin.

Through an array of small electrodes organized on a tip, radio frequency energy is transmitted
into the tissue, producing an injury in a certain pattern to the skin. The unaffected areas promote
faster healing and the result is an improvement in the tone and texture of the skin

5.1 Exclusion Criteria

 Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the
body

 Permanent implant in the treated area such as metal plates and screws, or an injected
chemical substance

 Current or history of any kind of cancer, or current condition of any other type of cancer, or

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 pre-malignant moles.

 Severe concurrent conditions, such as cardiac disorders.

 Pregnancy and nursing.

 Impaired immune system due to immunosuppressive diseases such as AIDS and HIV, or
use of immunosuppressive medications. *

 Patients with history of diseases stimulated by heat, such as recurrent Herpes Simplex in
the treatment area, may be treated only following a prophylactic regime.

 Poorly controlled endocrine disorders, such as diabetes. Any active condition in the
treatment area, such as sores, psoriasis, eczema, and rash.

 History of skin disorders, keloids, abnormal wound healing, as well as very dry and fragile
skin.

 History of bleeding coagulopathies, or use of anticoagulants.

 Face lift or eyelid surgery (if periorbital treatment is performed) within a year prior to
treatment.

 Facial dermabrasion, facial resurfacing, or deep chemical peeling within the last three
months, if face is treated.

 Neurotoxin/collagen/fat injections or other methods of augmentation with injected bio-

material in the treated area within 6 months prior to treatment.

 Use of Isotretinoin (Accutane®) within 6 months prior to treatment.

 Use of non-steroidal anti-inflammatory drugs (NSAIDS, e.g., ibuprofencontaining agents)

one week before and after each treatment session.

 Any surgical procedure in the treatment area within the last 6 months or before complete
healing.

 Treating over tattoo or permanent makeup.

 Excessively tanned skin from sun, tanning beds or tanning creams within the last two weeks.

 As per the practitioner's discretion, refrain from treating any condition which might make it
unsafe for the patient.

(*) Indicated conditions may be treated at the discretion of – and under the full responsibility of
the medical director/physician, although treatment is not recommended. In such cases, a small
area should be treated and assessed a few days later to determine if the patient will tolerate the
treatment without developing short-term adverse effects. Test spots cannot indicate long-term
adverse events.

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5.2 Possible Side Effects

Improper use of the system could result in side effects. Although these effects are rare and
expected to be transient, any adverse reaction should be immediately reported to the physician.
Side effects may include any of those conditions listed below. Side effects may appear either at
the time of treatment or after.

The side effects may include:

 Discomfort or significant pain post-treatment

 Excessive skin redness (erythema) and/or swelling (edema)

 Damage to natural skin texture (crust, blister, burn)

 Change of pigmentation (hyper- and hypo-pigmentation)

 Scarring

Treatment of male patients in hair-bearing areas may result in some damage to the follicles and
subsequent loss of hair. Avoid the beard area and other hair- growing zones if the patient does
not wish to experience hair growth reduction.

5.3 Pre-treatment
 Complete or update the patient's medical and physical history.

 Exclude from treatment patients presenting any contraindications for treatment.

 Determine why the patient is seeking treatment and what the expectations are.

 Inform the patient about the treatment protocol, typical treatment results and possible
adverse effects and discomfort.

 Instruct the patient about safety aspects he/she should observe.

 Advise the patient to avoid skin irritation or intentional skin tanning. Sun-screen is advisable
when outdoors during daylight hours.

 The patient should discontinue any irritant topical agents for 2-3 days prior to treatment.

 The patient should arrive for treatment with clean skin.

 There should be no lotion, make-up, perfume, powder or bath/shower oil present on the skin
in the area to be treated. Shave any hair in the treatment area.

 No lotion, gel or coupling medium should be used during treatment.

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 Areas of dental crowns, caps, braces, or other metal dental implants may be more sensitive
to treatment and the clinician may use dental rolls, gauze or a tongue depressor to isolate
the area and make the treatment more comfortable.

 Applicator cleaning: before each treatment clean the entire applicator surface with a medical
disinfectant.

 Ensure that it is dry before beginning the treatment.

 Connect the tip to the distal port of the applicator and ensure that the tip is secured in place

 Check the integrity of the tip's electrode-pins; ensure that none are missing. Do not use if
any pins are missing.

 Each tip has to be per patient and per treatment

5.4 Test Treatment

When beginning a new treatment, perform a small test spot in a non-conspicuous area of the
treatment site, prior to the first complete session. Test spots are performed to establish the
following requirements:

1) Confirm the patient's suitability for treatment: for skin types I – III wait 24-48 hours before
assessing the skin response, and for skin types IV-VI wait 5-7 days.

2) Establish and confirm treatment parameters: if the desired end-point of erythema and
edema – in a tip-shaped pattern – has not been achieved within 10-15 minutes, increase
the RF indicator level. If the response is excessive, decrease the parameters.

Test spot results will indicate if the patient can tolerate the treatment without developing adverse
effects. According to patient tolerance to the test spot, you may determine treatment parameters
and whether anesthesia is needed. In addition, it is advisable to perform a test spot whenever
changing parameters.

5.5 Treatment Procedure

1. Shave any hair in the treatment area.

2. Ensure skin is completely dry during the entire treatment. If skin moistens during treatment
(i.e., perspiration, etc.) re-wipe the skin with an alcohol pad and ensure that the skin is
completely dry before continuing treatment.

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3. When treating full-face, after completing the first half of the face, make sure to dry the
untreated half before commencing treatment.

4. Set the treatment parameters

5. Set the desired energy level according to the skin type, severity of the treated condition,
treatment area, bone proximity, etc.

6. Set conservative parameters for a test spot for the first treatment, and then gradually
increase during treatment or in subsequent treatments according to desired impact and test
spot results.

7. Select the desired tip pattern, and enable automatic operation mode, if you wish.

8. Treatment consists of a single pass over the treatment area. Adjust treatment parameters
according to the test spot response.

9. To perform treatment, place the tip on the target zone; perpendicular to the skin surface and
with full contact with it.

10. Emit a pulse by pressing the applicator's trigger; this will create a tip-shaped pattern on the
patient's skin that will appear 1-2 minutes later.

11. Move the applicator to an adjacent spot on the skin, emit another pulse. There should be no
untreated gaps between the pulses, be careful not to overlap the treated zones.

12. Examine the treated area. The immediate responses, indicative of the desired effect, are
erythema and edema in the immediate area of the tip-shaped pattern and possibly also
around it. The edema usually appears 1–2 minutes after pulsing and reaches its peak (of
up to moderate edema) within 30 minutes. It should be noted that erythema is not easily
noticeable – if at all – in darker skin types, so the edema will be more prominent in these
patients.

13. Untreated patches of skin: after completing a full pass on the entire treatment area, if
untreated patches of skin are apparent, re-treat these patches with the following procedure:

 Wipe the untreated patch of skin with a dry gauze pad.

 Treat the untreated patches of skin as normally.

14. Fine-tuning of the parameters should be done before proceeding to treatment of the entire
facial sub-area with the selected parameters.

15. Treatment consists of a single pass over the designated area.

16. The applicator tip should be placed on the skin, a pulse emitted, then lifted and moved to an
adjacent spot of the skin.

17. The emitted pulses should create tip-shaped patterns, and leaving no untreated gaps
between them, while also being careful not to overlap the affected zones.

18. The parameters can be modified during subsequent visits, as per the practitioner's

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 discretion.

5.6 Treatment Protocol

The number of treatment sessions depends on the individual patient and typically varies between
3-4 sessions, every 4-6 weeks.

One touch-up session may be needed every ~6 months, according to individual response.

5.7 Treatment Parameters

Selecting the appropriate RF Energy level is essential for successful treatment.

Always start with a low energy level and observe the skin's reaction before increasing the energy.

When applying energy to tissue, there are different effects achieved in the tissue: at a relatively
low increase of temperature there may be activation of cellular components of the skin; further
temperature increase may lead to cellular destruction (necrosis/coagulation) and an even further
temperature increase leads to ablation.

5.8 Post Treatment Care

 Post-treatment emollient cream should be applied to the treatment area.

 Post-treatment cooling is not necessary. In the event of post-treatment discomfort, it is

recommended to cool the treated area immediately with air cooling. Cold (not frozen) packs
may also be used. Blistered or ulcerated skin can be treated with a prescribed cream.

 Tiny scabs of less than 1 mm diameter will usually form 24-72 hours post treatment and may
remain for several days. The scabs should not be touched or scratched even if they itch,
and should be allowed to shed off naturally.

 Blistered or ulcerated skin can be treated with a prescribed antibiotic ointment or burn
treatment cream as per physician's discretion.

 During the first two days following treatment, care should be taken to prevent trauma to the
treated site: avoid hot baths, massage, etc.

 The skin should be kept clean to avoid contamination or infection; any mechanical or
thermal damage to the area must be avoided.

 Moisturizer may be applied only several hours (~½ a day) after each treatment and then

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 should be applied regularly throughout the course of the treatment. Make-up may be applied
only 12 hours after each treatment if desired, unless an unwanted reaction occurs in the
area. Generally 24 hours after treatment, patients may use regular soaps, but not scrub
soaps or exfoliants.

 The patient should use a high-factor sunscreen (at least 30 SPF) and protect the treated
area from sunlight for at least one month after the treatment Tanning of any sort (sun
exposure, tanning beds, and artificial sunless tanning lotions) is not allowed in the treated
areas during the entire course of the treatment. Tanning after treatment may cause
hyperpigmentation.

5.9 Follow-Up
The following are recommendations for post-treatment follow-up. The most suitable regimen for
each patient should be determined after reading this section.

 The patient should return 2-3 days after treatment to ensure that no adverse events have
occurred.

 The patient should return several weeks (4-6) after the last treatment for evaluation of the
treatment area.

 Update the patient's medical history before each session while being mindful of sun tanning,
new medications, etc. If the patient has not violated the contraindications, treatment may be
performed.

 Prior to treatment, perform a test spot in order to choose the adequate treatment parameters.

 If no results are observed and adverse events are noticed, treatment should be discontinued.

Treatment Conclusion
Treatment should be concluded when the results are satisfactory to the patient or according to
the physician's discretion. Generally 3-4 sessions within 4-6 weeks are needed. Do not perform
more than five consecutive sessions.

Chapter 6 Maintenance

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This chapter describes the routine maintenance procedures users should perform: cleaning the
various Apparatus.

All other service/maintenance procedures are to be performed by the company’s authorized

service personnel ONLY!

For continued protection against fire, replace the fuse ONLY with one of the same type and
rating.

Cleaning the System

 All of the System’s external parts should be cleaned / wiped down at least once a week.

 Turn off the system before wiping down any of the surfaces to ensure safety

 The treatment handle have to be cleaned after each treatment by using alcohol wipes or
alternative means.

 Avoid using detergents that can damage or destroy external plastic such as ammonia,
acetone, hydrochloric acid, chlorine bleach, etc.

Chapter 7 Troubleshooting
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Failure Correction

No Power  Check the power cable.

 Make sure that the Plug cable is inserted into both the
wall socket and the System inlet.

 Make sure that main front switch is in "on" position.

 If the cable is connected properly and still there is no

power, contact your local distributor.

No Display  Turn the system to its “ON” position on the front

panel.

 Check the power cable. Make sure that the Plug cable
is inserted into both the wall socket and the System
inlet.

 Restart System (turn System off for 2 minutes and then

turn System on).

 If still there is no display, contact your local distributor

Touch Screen Does Not  Restart system (turn system off for 2 minutes and then
Respond turn System on).

 If the screen still does not respond, contact your local

distributor

No Energy in treatment tips  Make sure Applicators are connected properly.

 If the Applicators are connected properly and still there

is no energy in Applicators, contact your local
distributor

Fuse is blown In the event that  Make sure to disconnect system from wall electricity
you switch “ON” the system
 On the rear panel, you will find the inlet with a fuse box.
and nothing appears on the
screen, it is most likely that the  Pull the fuse drawer out using a flat screwdriver.
main fuse burnt.
 Remove the two fuses and check if they are burnt.

 Replace fuses if necessary as shown on figure below

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Chapter 8 Technical Specifications

Output Frequency 2-4MHZ

Output power 10-200W

Treatment tips 10p 25p 64p Nanocrystals

Input voltage AC 110V~220V~50Hz/60Hz

Chapter 9 Contact us

Beijing Sincoheren S&T Development Co.,Ltd

Web: www.sincoherengroup.com

Service number: +8618701341926

Add: Lvl 4, SinoTrans plaza, Haidian District, Beijing, China 100044

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