ViOL SYLFIRM X User manual

SYLFIRM X User Manual

Contents
Chapter 1. Product Introduction
1.1 Introducing SYLFIRM X
1.2 Intended Purpose
Chapter 2. Information on Safety and Handling
2.1 Safety Precautions
2.2 Prohibited Usage
2.3 Usage and Storage Conditions
2.3.1 Conditions for Usage
2.3.2 Conditions for Storage
2.3.3 Condition for Cleaning
Chapter 3. Components and Installation of SYLFIRM X
3.1 Main Device Components
3.2 Accessory Components
3.3 User Interface (UI)
3.4 How to install SYLFIRM X
3.5 Precautions
3.6 Power off
Chapter 4. Using and Operating SYLFIRM X
4.1 How to Use SYLFIRM X
4.1.1 UI operation
4.1.2 Application Procedure
4.2 Specifications, Software, and Data Outputs of SYLFIRM X
4.3 Error Messages and Alarm
Chapter 5. Labels and Packaging
5.1 Labels
5.1.1 Label for Main Device
5.1.2 Label for Consumable Tip
5.1.3 Label for Hand-piece
5.1.4 Label for Foot Switch
5.1.5 Label for CART

5.2. Packaging
5.2.1 Package List
5.2.2 Package Units
Chapter 6. Information on EMC
6.1. Guidance and Manufacturer’s Declaration – Electromagnetic Emissions
6.2. Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
6.3. Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
Chapter 7. Product Life time and Warranty
7.1 Product Life time
7.2 Product Warranty
Chapter 8. Manufacturer Information
Chapter 9. Deputy in Europe

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Chapter 1. Product Introduction
1.1 Introducing SYLFIRM X
This device is intended for coagulating skin tissue by emitting high frequency electricity (2MHz).
The product consists of a Main device, Hand-piece, Foot switch and Consumable Tip.
•Product Type–General-purpose electric surgical device
•Name– SYLFIRM X
•Manufacturer–VIOL Co., Ltd.
•Country of Origin –South Korea
1.2 Intended Purpose
This product treats budding acne and minimizing acne scars by using High Frequency from
electrode.

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Chapter 2. Information on Safety and Handling
2.1 Safety Precautions
Before treatment, the doctor must explain cautions to the patient
1) Operate the product in the correct order as described in this manual.
2) Patients with electrically conductive implants(artificial cardiac pacemaker, cardioverter
defibrillator, or other implantable electric devices) should qualified advice before use.
3) Be cautious when installing the product.
①Vibration and shock, for example, while transporting.
②Inappropriate voltage for power supply.
③Unstable contact with the ground.
4) Beware of the following as for power supply.
①Always ensure the supplied voltage is AC 100-240V before plugging in the device.
②Turn off the power switch after using the device and pull out the plug when off-work.
5) 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 re-orienting the equipment
6) Ensure that the distance between the product and the wireless device is at least 0.3 m.
7) This product generates electrical arcs during operation, which can damage tissues such as
neuromuscular. Therefore, only be operated by personnel that has completed relevant
training approved by the manufacturer.
8) If the safety standards are not met when installing this product or operating table, it may be
highly dangerous to use the device.
①Do not use “multiple-tap” for power supply.
②If multiple devices are supplied by a single outlet source, consult a professional
electrician on the appropriateness of such configuration before operating this product.
9) It can be risky to use components that are second-hand or not supplied by the manufacturer.
10) It is considered normal for this product to cause noise to other electric medical devices (e.g.
monitor noise) during its operation.
11) Be aware that patient medical equipment (e.g. assistance device) may become damaged or
broken down when operating this product.
12) In addition to removing every metallic object such as rings and chains, patients need to avoid
contact with metallic parts that are grounded or contain enough capacitance for grounding
(e.g. the supporting area of an operation table).
13) Do not use flammable anesthetic gas when operating within cavum (e.g. membrane, organ).
①Make sure not to use or vaporize detergent, sterilizer, or inflammable solvent before
operation.

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②Operating the product may lead to a “spark” which can flare intestinal gas or oxygen-
containing objects (such as cotton and gauze).
14) Patients must not make contact with any grounded metal part or elastic conductor.
①Use dry materials to insulate body parts that give out excessive secretion or contact the
skin (e.g. arm, torso).
15) As this product is electrically operated and can be interfered by electromagnetic waves, do
not use other electric devices like cell phone when this product is in use.
16) Since this product is a medical device, instructions are required to properly dispose of it.
Contact the deputy or manufacturer for such instructions. Improper disposing of this device
can lead to legal consequences.
17) To avoid risks associated with electric shock, connect this product to a power supply using
the protective ground connector.
18) Adhere to the following for safely turning off the product.
①Reset the device to its default settings when finished operating it.
②Do not pull out the plug with one hand using excessive force.
19) Do not set this equipment up at closed place and narrow place, and power plug placed
difficult place to remove.
20) If the equipment fails, the unintended output power may increase or decrease. In this case,
contact the manufacturer.
21) Contact the manufacturer if the product functions abnormally, problematically, or not at all.
Any attempt to repair without the manufacturer’s guide is not recommended.
22) The conducting wire for patients should be situated in ways that do not make contact with
either the patient or other wires. Any active electrode that is temporally not in use should be
stored in locations that are insulated from the patient.
23) Crusting, Edema may be observed right after treatment, however these symptoms are
temporary and normally expected during and after the treatment.
24) Reuse of the tip is prohibited in any circumstances due to the infection.
25) Re-sterilization is prohibited in any circumstances.
26) Properly shut down, disconnect and secure the hand-piece and foot switch connector before
moving it. Failure to do so may damage the system or cause someone to trip over a loose cable.
27) If any abnormality occurs during use, please contact Manufacturer. Our information is on the
Chapter 8.
28) The safety load weight is as follows.
A. Hand-piece holder: 0.5 kg
B. Hand-piece cable holder: 0.5 kg
C. Cart tray: 10 kg
D. Cart handle: 5 kg

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2.2 Prohibited Usage
1) Pregnant or breast-feeding mothers
2) A current sign or medical history of skin cancer, other cancer types, and/or precancerous
wart.
3) Critically ill patients (for example, with a heart-related disease).
4) Compromised immune system due to AIDS, HIV, and/or drug.
5) Heat-sensitive disease; for instance, preventive drug treatments are needed for remedying
recurrent herpes simplex.
6) Endocrine disorders that are hardly manageable (e.g. diabetes).
7) Patients who currently undergo progressive acute disease (e.g. eczema, psoriasis, decubitus,
rash & etc)
8) Those with a history of impeded recovery from skin disorder, keloid, and/or any injury.
9) Patients with impaired blood clotting or who have consumed or injected an anticoagulant
drug in the last 10 days.
10) Those who are deemed unsuitable for such operation at the surgeon’s discretion.
2.3 Usage and Storage Conditions
2.3.1 Conditions for Usage
1) Temperature: 10℃-30℃
2) Relative humidity: 30%-75%
3) Atmospheric pressure: 700hPa-1060hPa
2.3.2 Conditions for Storage
1) Temperature: −20℃-60℃
2) Relative humidity: 10%-90%
3) Atmospheric pressure: 500hPa-1060hPa
2.3.3 Condition for Cleaning
1) Clean the device with soft, dry cloth
2) Equipment failure may occur due to dust and debris during long-term use of the
equipment

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Chapter 3. Components and Installation of SYLFIRM X
3.1 Main Device Components
No. Name Description
1 ON/OFF Switch For turning the power on and off
2 Display LCD A display that shows current operational settings
3 Operation Touch Screen For configuring operational settings or functions
4 Power LED Led for check the power
5 Jog Dial
A dial that changes functional values or equip mode for consumable
tip.
6 Hand-piece Holder A part that holds the Hand-piece in place
7 Hand-piece Connector Connector between the Hand-piece and the main device
8 Foot switch Connecter Connector between the foot switch and the main device
9 Power Inlet For turning the main power on and off
10 Back Cover
A cover that can be removed when repairing or replacing
components of the main device

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3.2 Accessory Components
1) Hand-piece
No. Name Description
1 Bi-polar Hand-piece Component that equips the consumable tip
2 Hand-piece Connector Connector to the main device
3 Flexible Cable Cable protector
2) Foot switch
No. Name Description
1 Foot switch Stepper RF Energy Start/Stop during operation
2
Foot switch
Connector (2p) Connector to the main device
3 Foot switch cable
Cable for connecting with foot switch stepper
and connector
4 Foot switch case
Case for protecting and using the foot switch
stepper

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3) Consumable Tip(Applied part)
①Cap ②Body
No. Name Description
1 Cap Removable Cap
2 Body Consumable Tip
-This Consumable Tip is blister-packaged and EO-sterilized. If the tip is unclean or exposed to the
air due to damage to its package, do not use the tip. When it scraps, do not mix up with other
wastes.
-The Consumable Tip is disposable and can be used only once for each patient.
-The part which touches the skin is shaped as a square of 1cm2 and consists of 25 pins.
-Detailed specifications of the Consumable Tip are as follows.
No. Item Description
1 Electrode Material SUS 304 with gold coating
2 Electrode Quantity 25 pins
3
Molded Assembly
Quantity
4 pieces (cap, housing, PCB holder, PCB holder
support)
4 Mold Material PC (Polycarbonate)
5 Sterilization Method EO gas
6 Number of Usage Once (disposable)
7 Depth 0.3 mm – 4.0 mm
8 Energy Per Electrode Approximately 13.5 mJ - 67.6 mJ

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4) Cart
No.
Name
Description
1
Tray
For mounting Main body
2 Caster For moving or anchoring the main device
3
Connector hole
For power cord and foot switch connection hole
4 Handle Handle for moving the main device
5
Hand-piece cable
hanger
Hanger the hand-piece cable
6 Drawer Space to store accessories

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5) User Manual
No. Name Description
1 User Manual
Manual for safe and efficient
usage

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3.3 User Interface (UI)
i. Operation UI– Upper screen
No.
Name
Description
1 Current operation mode display The mode being operated
2 Auto Shot Interval display
Display of interval time between motor movements in Auto
Shot (0.1 ~ 1.0 sec)
3 Shot Count display Display total number of shot count
4 Depth display Display microneedle penetration depth (0.3 ~ 4.0 mm)
5 Power display
Display RF output power level (Level 0 ~ Level 12)
- Level 0: No RF output
- Level 1 ~ 12: As the level increases, the output increases.

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ii. Operation UI –Llower screen
No.
Name
Description
1 Setup button Administrator screen activation button
2 RF output selection button
Select one of 8 types of RF output signals
Continuous Wave(CW1, CW2, CW3, and CW4) and
Pulsed Wave(PW1, PW2, PW3, and PW4)
3 Interval button
Set the interval time between motor movements in Auto
Shot
4 Depth button
Set the depth of microneedle penetration depth (0.3 ~ 4.0
mm)
5 Power button Set the RF output power level (Level 0 ~ Level 12)
6
Interval/Depth/Power control
button
Control button to increase or decrease the Interval/Depth/
Power settings
7 Shot Count RESET button Reset the total shot count number to 0
8
AUTO/SINGLE Shot Mode
selection button
Set single shot or auto shot (automatically repeated shots)
9 STANDBY/READY selection button
STANDBY button to configure all settings and READY button
for operation (configuring of settings is not available if the
READY button is activated)

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3.4 How to install SYLFIRM X
1) Connection of Hand-piece
< Hand-piece >
< Main device >
i. Connect the hand-piece's female connector (2) to the hand-piece connector (7) on the right side of the
main device.
ii. The hand-piece connector is a directional connector and must be gently fastened in the correct direction.
Be careful when inserting forcibly while the direction is not correct because it may damage the equipment.
iii. After inserting the connector, check the fastened state (if it is tightened vertically, it is properly fastened).
When the fastening is completed, fasten the securing latch (7.1).
iv. If the hand-piece connector is installed incorrectly, the following error message will be generated when
setting up the equipment.
< Error message >

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2) Connection of Hand piece hanger
< in side of Accesory box >
i. Insert the Rod-2 into the Rod-1’s upper hole indicated in the image above. Use the wrench to
tighten(clockwise) the bolt inside Rod-2 to secure it.
< Rod-1 >
< Assemble Rod-1 and Rod-2 >
ii. Insert the Rod-3 into the Rod-2’s upper hole indicated in the image above.
< Rod-3 >
< Assemble Rod-2 and Rod-3 >

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iii. Connect the Rod-3 to the Rod-2’s open end. Use the wrench to tighten the bolt inside the Rod-3.
※Note that the hook at the end of the Rod-3 should face upward (“U” shape)
iv. Use the wrench, rotate clockwise to tighten the bolt inside the lower hole of the main component as shown
in the image above.