Cynosure Potenza P1-08 User manual

OPERATOR
MANUAL
JMUM_PTZ_03, Rev. 1, 10/2020
TM

TABLE OF CONTENTS
CHAPTER 1  INTRODUCTION 6
1.1 Purpose and Scope 6
1.2 Potenza Overview 6
1.3 Intended Use of the Potenza 6
1.4 Component List 6
CHAPTER 2  SAFETY 8
2.1 General Safety 8
2.2 Medical Safety 8
2.3 Contraindications 8
2.4 Warnings 8
2.5 Caution 10
2.6 Precautions 11
2.7 Potential Side Effects 11
2.8 Electrical Safety 12
2.9 Cautions for Installation and Transportation 14
2.10 Preventive Check or Maintenance Repair Parts 14
CHAPTER 3  DESCRIPTION 15
3.1 Overview 15
3.2 Main Body 16
3.2.1 Front and Rear 16
3.2.2 Side 18
3.3 Handpiece (Applied Part) 19
3.3.1 Motor Handpiece 19
3.3.2 AC Handpiece 20
3.4 Electrode (Tip) 20
3.5 Motor handpiece Tip (Applied Part) 21

3.6 AC Handpiece Tip (Applied Part) 22
3.7 Neutral Electrode (Return Pad) (Applied Part) 23
3.8 Footswitch 24
3.9 Other Accessories 24
CHAPTER 4  INSTALLATION 25
4.1 Operating environment 25
4.2 Unpacking 25
4.3 Conditions for Device Installation 25
4.4 Installation of Main Body 26
4.5 Installation of Tips 28
4.5.1 Installation of Motorised Needle Tip 28
4.5.2 How to disassemble the motorised tip (reverse order of installation) 28
4.5.3 Installation of One-Needle Tip 28
4.5.4 How to Disassemble the One-Needle Tip (reverse order of installation) 29
CHAPTER 5  OPERATING INSTRUCTION 30
5.1 Preparation for Use 30
5.2 Turning Off Device 35
5.3 Disposal 35
CHAPTER 6  STORAGE & TRANSPORTATION 36
6.1 Storage and Transportation Conditions 36
6.2 Storage 36
6.3 Transportation 36
CHAPTER 7  CLEANING & MAINTENANCE 37
7.1 Cleaning 37
7.2 Maintenance 37

CHAPTER 8  PACKAGING 38
8.1 Main Body and Handpieces 38
8.2 Disposable Products 38
8.3 Labels 39
8.3.1 Main Body 39
8.3.2 Accessories 40
8.3.3 Symbols 41
CHAPTER 9  SYSTEM 42
9.1 Kinds of Pop-Up Messages 42
9.2 Kinds of Guide Messages 44
CHAPTER 10  TECHNICAL SPECIFICATION 46
10.1 RF Type 46
10.2 Power 46
10.3 Frequency 46
10.4 Repetition Rate 46
10.5 Handpieces 46
10.6 Tips 46
10.7 Needle Thickness 46
10.8 Treatment Duration 46
10.9 Electrical Power 46
10.10 Dimensions 47
10.11 Weight 47
10.12 Cart 47
10.13 Footswitch Specication 47
10.14 Sterilisation 47
10.11 Lifetime 50

Chapter 1 Introduction6
CHAPTER 1 INTRODUCTION
1.1 Purpose and Scope
This Operator Manual provides information on conguration, components, intended use, features, caution and
instructions about how to operate the Potenza.
CAUTION
✗All Personnel involved with the operation or maintenance of Potenza must be thoroughly trained and
understand this operator manual prior to the use of the Potenza machine.
✗Potenza should only be used by physicians and staff who have been appropriately trained.
1.2 Potenza Overview
This Potenza is used for coagulation using high frequency current. This device consists of the main body, two
types of handpieces, a handpiece (HP) holster, disposable electrodes, neutral electrodes, neutral electrode cable,
footswitch and power cord. It is controlled by software. The electrosurgical unit uses separately authorised
products, which operate under the principle that the coagulation of skin tissue occurs with the heat introduced by
the load or contact resistance when high frequency (RF) energy is transmitted into the tissue.
1.3 Intended Use of the Potenza
Fractional RF Microneedle Electrosurgical Unit is intended for use in dermatologic and electronic surgical
procedures for electrocoagulation and hemostasis.
1.4 Component List
The Potenza consists of the following components (illustrations and chart):
Main Body Tip Footswitch Neutral electrode
Handpiece

Chapter 1 Introduction 7
TABLE 1: DEVICE LIST
No. Name Quantity Remarks
1Main Body 1 unit -
2Handpiece
Motor handpiece 1 ea.
AC Handpiece 1 ea.
4
Tip
I-49 5 ea.
Starter kit
Optional (Specied
Parts) Applied Part
S-49 10 ea.
I-25 10 ea.
S-25 20 ea.
CP-21 10 ea.
One needle: A1-15 5 ea.
5
I-16 5 ea.
Optional
S-16 5 ea.
C21-2 5 ea.
C21-1 5 ea.
C9 5 ea.
One needle: P1-08 5 ea.
One needle: A1-12 5 ea.
6Neutral Electrode Pad 5 ea. Applied part
7Neutral Electrode Pad Cable 1 ea. -
8Footswitch 1 ea. -
9Powercord 1 ea. -
10 Handpiece Stand 1 ea. -
11 Operation Manual 1 ea. -

8Chapter 2 Safety
CHAPTER 2 SAFETY
2.1 General Safety
• Do not operate the Potenza before thoroughly reading and understanding this manual.
• The Potenza device should only be used by physicians and staff who have been appropriately trained.
• If a problem occurs when using the Potenza, please contact the Cynosure Customer Service.
• Do not attempt to repair and modify the Potenza.
• Unauthorised or improper repairs, changes or modication performed by unauthorised personnel may be
hazardous.
2.2 Medical Safety
• There is no limit in the application of this Potenza on clients in terms of age or gender; but the physician should
determine whether to use this product on a client after checking the client’s health status.
• This product can be used for both men and women.
• This product can be used for both men and women without physical problems such as cardiovascular disorders.
2.3 Contraindications
Do not use this product on clients listed below:
• Clients with a pacemaker.
• Clients who have previously had a gold-thread skin-rejuvenation treatment.
• Clients with keloid formation propensity.
• Clients with skin infections.
2.4 Warnings
• Do not use the Potenza on a client with electronic implants, such as a cardiac debrillator, without consulting
with a qualied professional (i.e. cardiologist). It may interfere with the operation of electronic implants or
damage the implants, causing risks.
• Since there is a risk of re or explosion, do not use this product near ammable materials (i.e., ammable gas or
anesthetic, etc.) or volatile materials (i.e., ether or alcohol, etc.).
• Store the unplugged Potenza device and equipment in a clean, dry and secure location when not in use. Incidental
contact with the equipment may result in a burn.
• Check the electrical cords, equipment, accessories and cables for cracks or exposed wires, etc., before every
use. Using the device with damaged cables, cords, accessories, etc., may result in a burn or other injury to clients
or users.
• When RF current is not activated for a moment during operation, be careful because the surface of the active
electrode may be hot enough to burn a client.
• Since injury or electric shock may occur on clients or users, connect adapters or accessories to the equipment
only when the power is off.
• The treating physician is responsible for selecting appropriate and safe treatment parameters at all times.
• The power inlet must be easily accessible.

9
Chapter 2 Safety
• The entire area of the neutral electrode pad should be securely attached to the client’s body as close to the
treatment site as possible.
• The client must not come into contact with metal parts which are earthed or which have an appreciable
capacitance to earth (i.e., operating table supports, etc.).
• Skin-to-skin contact (i.e., between the arms and the body of the client) should be avoided. Place dry gauze
between the parts with skin-to-skin contact.
• The cables to the electrodes should be positioned in such a way that contact with the client or other leads is
avoided.
• Temporarily unused active electrodes should be stored securely in the holster and out of reach of and contact
with the client.
• For surgical procedures where the high frequency (HF) current could ow through parts of the body that have
a relatively small cross-sectional area, the use of bipolar techniques may be desirable to avoid unwanted tissue
damage.
• The output power selected should be as low as possible for the intended purpose. Certain equipment or
accessories may present a safety hazard even at low power settings.
• Apparent low output or failure of the HF surgical equipment to function correctly at the normal operating
settings may indicate faulty application of the neutral electrode pad or poor contact in its connections.
• Before selecting a higher output power, the application of the neutral electrode pad and its connections must
rst be checked.
• Non-ammable agents for cleaning and disinfection are recommended wherever possible.
• Flammable agents used for cleaning or disinfecting, or as solvents of adhesives, should be allowed to evaporate
before the application of HF surgery. There is a risk of pooling of the ammable solutions underneath the client
or in body depressions such as the umbilicus or in body cavities such as the vagina. Any uid pooled in these
areas should be mopped up before HF surgical equipment is used.
• For a client with a cardiac pacemaker or other active implants, a possible hazard exists because interference
with the action of the pacemaker may occur–or the pacemaker may be damaged. When in doubt, approved
qualied advice should be obtained.
• Interference of HF surgical equipment may adversely inuence operation of other electronic equipment.
• For situations where the maximum output voltage is less than or equal to 1600 V, associated equipment and
active accessories should be selected that have a rated accessory voltage equal to or greater than the maximum
output voltage.
• Failure of HF surgical equipment could result in an unintended increase in output power.
• With modes which produce electrical arcs between the active electrode and tissue, risks resulting from
neuromuscular stimulation may occur.
• The following precautions are necessary to prevent burns at the neutral electrode pad (return pad) site:
-Do not cut or modify the neutral electrode pad or its connector in any way.
-Select an area that is free of hair and tattoos, has minimal curvature, and is appropriately distanced
from the treatment area.
-Inspect the cable and connector for any signs of damage or wear that may have produced exposed
wiring or other defects.

10 Chapter 2 Safety
-Regularly check that the neutral electrode pad cable connections are intact.
-Poor neutral electrode pad contact may lead to low RF delivery and/or a system error condition.
• When setting HF output, the maximum output voltage should not exceed the rated accessory voltage.
• Peak rated accessory voltage is 400 V.
• Unauthorised cables and accessories may have an adverse effect on electromagnetic compatibility (EMC)
performance and safe operation.
• An accessory that is not manufactured by the manufacturer for use with the Potenza must not be attached to
the system to prevent potential injury and/or equipment damage. Rated voltage accessories must be used.
• It is recommended that monitoring electrodes are placed as far as possible from surgical electrodes when HF
surgical equipment and physiological monitoring equipment are used simultaneously on the same client.
• Operators must take care to avoid simultaneously touching any part where the current ows (i.e., fuse holder,
earth, power cord, rear connector, handpiece output section, etc.).
• The essential performance of medical electrical (ME) equipment and a description of what the operator can
expect if the essential performance is lost or degraded due to EM disturbances are below:
-Monitor icker
-Touchscreen error
-A warning that other cables and accessories may negatively affect EMC performance
-A statement that portable RF communications equipment including antennas, can affect medical
electrical equipment. The warning includes a use distance such as “… be used no closer than 30 cm
(12 in) to any part of the ME equipment, including cables specied by manufacturer”.
• For ME equipment and ME SYSTEMS that are classied as class A according to CISPR 11, the instructions for
use (IFU) include the following 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 re
-orienting the equipment.”
• Strong static (15kV) electricity between the handpiece and the tip may cause some equipment to stop
functioning.
• Please refer to the spec sheet provided by the manufacturer, as the output may be different from the displayed
watt at the impedance that is out of the rated load (200).
2.5 Caution
• For Potenza tips, check the packaging for damage and a valid expiration date before use; never use the product if
the sterilised package is open or damaged or if it is past the printed expiration date.
• If the sterile package has been opened or damaged, discard the contents.
• Clients should be advised to be careful not to expose the treatment area to external stimulation for two days
post treatment.
• Clients should be advised to refrain from intense exercise, hot baths or saunas, which may cause an increase in
skin temperature, for ve days post treatment.

11
Chapter 2 Safety
• If a burn occurs on skin’s surface during treatment, the operator should stop treatment immediately and care for
the burn rst.
• If skin swells up severely during treatment, the operator should stop treatment immediately.
• If a patient complains of severe pain during treatment, the operator should stop treatment immediately and
consult with a physician.
• If a problem occurs with the equipment or on a patient during treatment, the operator should take suitable
actions by ceasing treatment and transferring the patient to a safe place.
• Be advised that the surface of the treatment tips is hot enough to cause a burn after RF current has been owing
through it.
• The physician should administer treatment only after considering the status of the patient.
• A light cold pack with ice may be applied on the area of treatment if it is hot after treatment.
• Clients should be advised to refrain from drinking alcohol or taking medicine that interferes with blood
coagulation, such as aspirin, for two weeks post treatment.
• Change to this product must not be made without the approval of the manufacturer. If product is changed,
suitable inspection and testing should be conducted for continuous safe use of the product.
• The container, which is attached to the handpiece stand, can accommodate up to 3 kg.
• The lithium battery should be replaced by Cynosure service personnel only.
• Non-continuous mode: Activation time: Max 30min / Deactivation time: Min 10min
2.6 Precautions
If the client presents with the following, do not use this product and obtain physician’s prescription before use:
• Herpes simplex
• Autoimmune disease
• Diabetes
• Epilepsy
• Pregnant and breast-feeding women
• Acute disease
• Hypertension
• Dermatitis
2.7 Potential Side Effects
• Temporary erythema: area of treatment may turn red right after treatment, but this symptom disappears within
48 hours after treatment.
• Temporary tingling: slight edema may occur right after treatment, but this symptom disappears within 48 hours
after treatment.
• Burning sensation: patients may feel uncomfortable temporarily while receiving treatment.
• Mild pain while the treatment
• Post therapy bleeding
• All side effects are resolved in two days after the treatment.

12 Chapter 2 Safety
2.8 Electrical Safety
POWER SAFETY
Check whether power cord is securely plugged into the outlet. Connect to a power dl source
that meets device and electrical specications. Otherwise, the equipment may malfunction.
Do not use if the electric wire is damaged in any way. It may result in a re due to electric
leakage.
Do not plug in with wet hands. It may result in electric shock.
Do not overload electrical outlets with power cords. It may result in a re.
INSTALLATION SAFETY
Do not place the device near an open ame.
Do not place electric wire near a heating device. Electric wires may melt and electricity may
leak from exposed wires.
To prevent risk of re, do not position or store the device near any combustible agents
including oil.
Keep the device out of direct sunlight and areas with high heat and humidity, as well as areas
with high levels of dust or salty air. Store device in a well-ventilated location
Ensure that adequate lighting is available where the device will be located and operated.

13
Chapter 2 Safety
TRANSPORTATION SAFETY
Be careful not to drop the handpiece. Lens embedded in the device may be broken.
Do not tilt the device.
Do not pour water over the device nor place heavy things on it.
When not in use, turn the device off and unplug the power cord from the electrical outlet.
HANDLING RELATED
Do not use the device near combustible items or objects. Always have a working re
extinguisher nearby in case of an emergency
If unit is not functioning correctly, stop treatment and call customer service. Do not repair
or dissemble. Service should be performed by a designated technician. Only regulated parts
should be used.
Do not use unnecessary force to remove the power cord.
• Only the power cord provided by the manufacturer should be used to prevent risk of electric shock. Do not
operate the equipment if the power cord is damaged or shows signs of wear.
• Use only Cynosure-supplied components and accessories.
• Since it may cause electric shock, be careful not to allow ingress of any liquid to this product
• Rated voltage of this product is AC 100-240V. Directly connect the power cord of main body into an outlet.
Overloading several plugs in one socket may result in a re.

14 Chapter 2 Safety
• To avoid the risk of electric shock, the Potenza must only be connected to a supply main with protective earth.
• If disassembled or external cover opened by persons other than authorised service personnel, it may result in
exposure to high voltage or high current. Never remove the cover of the handpiece or the main body.
• The Potenza meets IEC60601-1-2 for electromagnetic compatibility and is not likely to cause interference in
nearby electronic equipment. However, in order to avoid any possible risk, other electronic equipment should not
be stacked under or placed immediately adjacent to the Potenza.
2.9 Cautions for Installation and Transportation
• Be careful not to drop handpiece during transport.
• Do not tilt the equipment during transport.
• Keep the re extinguisher near the product to manage a re that may occur due to electric leakage.
• Do not keep the electric wire near any heating devices, since electric wire may be fused or short-circuited.
2.10 Preventive Check or Maintenance Repair Parts
• Motor Handpiece/AC Handpiece
• Neutral Electrode Pad Cable

15
Chapter 3 Description
CHAPTER 3 DESCRIPTION
3.1 Overview
The Potenza is a microneedling device which generates RF frequency of 1 or 2MHz that cause soft tissue
coagulation through tissue heating. A total of 13 microneedle tips that attach to one of two of handpieces are
available for treatments and should be used in accordance with the clinical reference guide (CRG). Changes to
the treatment parameters can be made by adjusting the settings on the LCD user interface. Once settings are
conrmed and veried by the qualied clinician, the device is placed in treatment mode and is ready for use. The
microneedle tip is placed on the desired treatment site and the foot pedal is depressed to transmit RF energy to
the tissue at multiple depths. The RF energy causes the molecules within the tissue to vibrate, resulting in a rapid
increase in temperature; this causes coagulation of the proteins within the tissue.
The monopolar mode requires that a neutral electrode pad be securely attached to the skin at an area adjacent to
the intended treatment site, i.e. the upper back for facial treatments.
Safely power off the device by depressing the switch on the top surface of the device when not in use.
Appearance of Product

16 Chapter 3 Description
3.2 Main Body
3.2.1 Front and Rear
FRONT REAR
FRONT
No. Name Function
1Motor Handpiece Holster Receptacle that securely holds the motor handpiece
2Motor Handpiece Delivery method for the electrosurgical device, which includes mounted
electrodes that coagulate the tissue using high-frequency current
3Operation Panel (LCD) Touchscreen user interface and display where adjustments to
treatment settings can be made
4Cable Stand Vertical stand for the handpiece cable
5AC Handpiece Delivery method for the electrosurgical device, which includes a
electrode that coagulate the tissue using high-frequency current
6AC Handpiece Holster Receptacle that securely holds the AC handpiece

17
Chapter 3 Description
REAR
No. Name Function
1Handpiece Holster Receptacle that securely holds the handpiece
2Motor Handpiece Port Port connecting the main body of the device to the handpiece via a
cable (motor handpiece position compatible)
3Mains Power Switch Mains power on and off switch for the device
4Power Cable Socket Socket for connecting the power cable
5AC Handpiece Port Port connecting the main body and the AC Handpiece Cable
6Motor Handpiece Port Port connecting the main body of the device to the handpiece via a
cable (motor handpiece position compatible)
7Footswitch Connection Socket Socket for connecting the footswitch
8Neutral Electrode Pad Socket Socket for connecting the neutral electrode pad
9Cable Stand Vertical stand for the handpiece cable
10 Device Power Switch Switch for turning the device on or off

18 Chapter 3 Description
3.2.2 Side
SIDE
NO. NAME FUNCTION
1Handpiece Holsters Receptacles that securely hold the handpieces
2Handpiece Delivery method for the electrosurgical device, which includes mounted
electrodes that coagulate the tissue using high-frequency current
3Operation Panel (LCD) Operation Panel (LCD) Touchscreen user interface and display where
adjustments to treatment settings can be made
4Cable Stand Vertical stand for the handpiece cable

19
Chapter 3 Description
3.3 Handpiece (Applied Part)
There are two types of handpieces available for use with the Potenza: the motor handpiece and the AC handpiece.
One or the other will be used depending on the treatment type.
3.3.1 Motor Handpiece
The motor handpiece automatically inserts the needles into the skin using a stepping motor. Because the needles
are quickly inserted into and retracted out of the skin, it reduces the pain of the treatment.
• Depth: Maximum of 4.0mm
• Two treatment modes: bipolar and monopolar
• Available tips:
S-49 TIP, I-49 TIP S-25 TIP, I-25 TIP S-16 TIP, I-16 TIP
C21-2 TIP,C21-1 TIP,C9- TIP CP-21 TIP
1 Overall Appearance 2 Description
NO. NAME FUNCTION
1Connection Port to Main Body A connection terminal used to connect the handpiece to the main body
2Handpiece Cable A cable for connecting the handpiece to the main body
3Handpiece Delivery method for the electrosurgical device, which includes mounted
electrodes that coagulate the tissue using high-frequency current
4Tip Connection Port Where the disposable needle tips are connected