OPERATION MANUAL

Ver. 1.0
ULTRAFORMER MPT (Model Name: UF4-M400)

The ULTRAFORMER MPT is intended for use only by properly trained physicians and properly
trained persons under the supervision of such a trained physician.

Users must thoroughly read and understand this manual prior to operating the device.
Improper use of the system may cause injury to parties and/or may cause damage to the
system that may void the warranty agreement.

Note 1. This user manual describes the operation of the ULTRAFORMER MPT only. It is not a
substitute for the required clinical training to use the system.

Note 2. Classys Inc. provides this manual in English by default. Classys Inc. also translates the
manuals into the language of each country sold in Europe only.
Table of Contents
1. Introduction to Manual 5. System Operation

1-1. Purpose 5-1. Overview of System Functions

1-2. Conventions 5-2. Activating the System

5-3. Treatment Steps

2. Safety Information 5-4. Shutting Down the System

2-1. Indications for Use

2-2. Contraindications 6. System Messages

2-3. Precautions

2-4. Potential Side Effects 7. Cleaning and Storage

2-5. Complaints and Adverse Events 7-1. Cleaning the Main Body,

Hand-piece and Cartridge

3. System Overview 7-2. General Care of the System

3-1. System Description 7-3. Movement, Storage and Disposal

3-2. System Components and Features 7-4. License and Software management

3-3. Precautions for use

8. Specifications
3-4. Safety Symbols
8-1. Specifications Table

4. Setting Up for First-Time Use

Appendix A.
4-1. Unpacking Electromagnetic Emissions and Immunity

4-2. Physical Environment

4-3. Connecting Components

1. Introduction to Manual
1-1. Purpose
This manual provides a description of the ULTRAFORMER MPT system components, displays,
operational instructions and other related information vital to the functions of the system.

Classys Inc. provides this manual in English by default. If the customer requires a translated
manual in another language, we will proceed with the request to the appropriate country
distributor.

WARNING: Do not operate the ULTRAFORMER MPT prior to reading this manual
thoroughly and being trained by an authorized Classys Inc. representative.
This manual is not a substitute for clinical treatment guidelines and training provided by the
company or its distributors.

1-2. Conventions
Caution: This signal alerts the user to precautionary steps necessary to
effectively 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.

Numbered sections are presented in steps and must be completed in sequence.

Bulleted lists indicate general information about a particular function or procedure. It does
not imply a sequential procedure.

ULTRAFORMER MPT Operation Manual |1

2. Safety Information
2-1. Indications for Use
The ULTRAFORMER MPT is a non-invasive therapeutic device for skin lifting and tightening.

2-2. Contraindications
The ULTRAFORMER MPT is not recommended for patients with the following:
⚫ Open wounds or lesions on the treatment area

⚫ Severe or cystic acne in the area of treatment

⚫ Metal stents / electrical implants in the treatment area

⚫ Bio-absorbable mechanical implants

⚫ Skin infections of any type

⚫ Hemorrhagic disorders or dysfunctions

⚫ Pregnancy or when breastfeeding

2-3. Precautions
Do not use the equipment without prior training and qualifications to operate the
ULTRAFORMER MPT. Consult with experts or use a diagnostic device to check the depth to
decide whether treatment is appropriate.
⚫ Anticoagulant therapy

⚫ Skin conditions caused by autoimmune diseases, skin cancer, and Herpes Simplex

⚫ Diabetes or epilepsy

⚫ Severe skin disease

⚫ Decortication, heart disease, hypersensitiveness, hypertrophic scar

⚫ Hypersensitiveness or hypertrophic scars

⚫ Hemostatic dysfunction

⚫ Avoid applying treatment on the thyroid gland, thyroid cartilage, and trachea

ULTRAFORMER MPT Operation Manual |2

 ⚫ Avoid applying treatment directly on the breast tissue and major vessels

Immediately stop treatment if the following occurs:

⚫ The surface of the skin burns
⚫ If the outer surface layer of skin rises by swelling

The following may occur post treatment:

⚫ Temporary pain or discomfort
⚫ Burns and scabbing
⚫ Neurological symptoms

2-4. Potential Side Effects

This equipment is a non-invasive focused ultrasound therapeutic device, which is to be
applied to the skin. This device has no serious adverse events or major side effects occurring
during clinical research. The following occurred during clinical trials:
⚫ Erythema (Redness): The treated area may exhibit erythema after treatment and
typically resolves within a few hours of treatment.
⚫ Edema (Swelling): The treated area may exhibit mild edema following treatment and
typically resolves within a week.
⚫ Pain: Momentary discomfort may be experienced during the procedure. If patients
experience post procedure discomfort, this typically resolves within 2 days.
⚫ Bruising: Mild bruising caused by damage to soft tissue blood vessels may occur
occasionally and typically resolves within 48-72 hours of treatment.
⚫ Scarring: If incorrect treatment techniques are used, scarring formations may occur.
⚫ 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.

ULTRAFORMER MPT Operation Manual |3

 - Transient pain, paresthesia and/or tingling maybe experienced.
- No permanent injuries to facial nerves have been reported.

2-5. Complaints and Adverse Events

No serious or adverse observations were made from the use of the preceding equivalent
devices in reference to the clinical study.

ULTRAFORMER MPT Operation Manual |4

3. System Overview
3-1. System Description

The ULTRAFORMER MPT is a non-invasive equipment. It is typically computer-controlled and

is capable of producing localized heat within tissues or organs. Energy delivered to the
patient is via an externally-mounted cartridge.
The life cycle of ULTRAFORMER MPT is 5 years.

3-2. System Components and Features

The ULTRAFORMER MPT consists of the following primary components as shown in the
Figure 3.1: The Main Body with the integrated 10.4-inch touchscreen, Hand-piece cable, AC
Power cable and interchangeable Cartridges.

Figure 3.1 Main components of the ULTRAFORMER MPT

ULTRAFORMER MPT Operation Manual |5

No. Item No. Item No. Item
ULTRA F ULTRA BOOSTER
1 Main Body 2 3
Hand-piece Hand-piece
ULTRAFORMER MPT ULTRAFORMER MPT ULTRAFORMER MPT
4 5 6
1.5 3.0 2.0
ULTRAFORMER MPT ULTRAFORMER MPT ULTRAFORMER MPT
7 8 9
4.5 6.0 9.0
ULTRAFORMER MPT DERMA BOOSTER CELL UP BOOSTER
10 11 12
13 1.5 3.0
LINE UP BOOSTER
13 14 AC Power Cable 15 Foot switch
4.5

3-2-1. Main Body

The Main Body is the information center for the ULTRAFORMER MPT. It houses the Graphic
User Interface (GUI) that allows the user to interact with the device. This screen sets and
displays the operating conditions including equipment activation status, treatment
parameters, and system messages. Figure 3.2 illustrates the physical features of the Main
Body.

Figure 3.2 Main Body front view (left) and rear view (right)

ULTRAFORMER MPT Operation Manual |6

No. Item Description

1 10.4” LCD Touch Screen Graphic User Interface (GUI)

2 Key Button Turn ON/OFF button

3 Insertion of Wireless LAN card Entrance to insert LAN card for using wireless LAN

4 Emergency Switch Operating Stop Switch when emergency

5 Hand-piece Holder Hand-piece holder

6 Locking Caster Moving wheel (Locking)

7 Knob Handle for stability when moving

8 Monitor disconnect Switch Used to remove the top monitor

9 Hand-piece Connector Cover Cover of socket for plugging in Hand-piece cable

The cartridges can be mounted with the cover
10 Cartridge holder (Back side)
where the connector connecting the body.
11 Main Power Switch AC power ON/OFF Switch

ULTRAFORMER MPT Operation Manual |7

 3-2-2. Hand-piece
One end of the Hand-piece is a connection output to attach the Cartridge. The other end
of the Hand-piece is connected to the insertion on the side of the Main Body. The Hand-
piece images are shown below in Figure 3.3. The Hand-piece trigger button is utilized to
apply the ultrasound shot.

Figure 3.3 Hand-piece without cartridge inserted, top and side views

No. Item Description

Red LED displayed when ultrasound energy is applied.

Green LED displayed when Cartridge connected to Hand-

piece and ready to apply shot.
1 LED indicator Blue LED displayed when the Hand-piece is connected and
recognized by the device.

Blue LED blinks when the Hand-piece and device

connection is not efficient.
Laches on either side for disconnecting on the Hand-
2 Cartridge Disconnect Switch
piece

3 Ultrasound Output Switch Hand-piece trigger to apply shot

4 Firmware connect cover Connect cover when firmware of Hand-piece changed

5 Hand-piece cable Cable for connecting Main Body and Hand-piece

ULTRAFORMER MPT Operation Manual |8

 3-2-3. Cartridge
Figure 3.4 is an illustration of the Cartridge. Both sides of the Cartridge marks maximum
treatment range. The front side indicates the center point for treatment. The Cartridge
marks the type and depth.

Figure 3.4 Treat Cartridge, separated from Hand-piece

No Item Description

1 Labeling Mark the Cartridge type

2 Treat guides Mark the Cartridge maximum length, treatment center point

The types of Cartridges vary in frequencies and treatment depths as shown in Table 3.1.

No. Cartridge Type Function Remark

Frequency: 7MHz, Depth: 1.5mm,

1 ULTRAFORMER MPT 1.5
Max. Power: 0.5J

Frequency: 7MHz, Depth: 3.0mm,

2 ULTRAFORMER MPT 3.0
Max. Power: 1.0J

Frequency: 5.5MHz, Depth: 2.0mm,

3 ULTRAFORMER MPT 2.0
Max. Power: 0.4J

ULTRA Frequency: 4MHz, Depth: 4.5mm,

4 ULTRAFORMER MPT 4.5 Optional
F Max. Power: 1.0J

Frequency: 2MHz, Depth: 6.0mm,

5 ULTRAFORMER MPT 6.0
Max. Power: 1.5J

Frequency: 2MHz, Depth: 9.0mm,

6 ULTRAFORMER MPT 9.0
Max. Power: 2.0J

Frequency: 2MHz, Depth: 13mm,

7 ULTRAFORMER MPT 13.0
Max. Power: 2.0J

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 Frequency: 7MHz, Depth: 1.5mm,
8 DERMA BOOSTER 1.5
Max. Power: 0.5J

ULTRA Frequency: 7MHz, Depth: 3.0mm,

9 CELL UP BOOSTER 3.0
BOOSTER Max. Power: 1.0J

Frequency: 4MHz, Depth: 4.5mm,

10 LINE UP BOOSTER 4.5
Max. Power: 1.0J
Table 3.1 Cartridge Types

3-2-4. Essential Accessories

The essential accessory is an ultrasound transmission gel. Ultrasound transmission gel
must be used at all times when treating.

3-3. Precautions for use

3-3-1. Warnings
⚫ To prevent unauthorized use of the ULTRAFORMER MPT, store in a controlled
environment only accessible by authorized and trained personnel.
⚫ For safety reasons, perform a test shot with the cartridge prior to performing a
procedure.
⚫ To avoid risk of electric shock, always inspect Cartridge, Hand-piece cable before use.
⚫ Do not use a cable or Cartridge that has been damaged or is leaking fluid.
⚫ When the Cartridge is damaged or torn, do not use and replace the Cartridge to operate
the System.
⚫ Power supply must be 100-240V~, 50/60Hz to operate the system safely.
⚫ The ULTRAFORMER MPT is intended for indoor, dry location use. Avoid liquid spills and
splashes.
⚫ Do not place the System in vicinity of direct sun light, high humidity or nearby heating
devices.
⚫ Gel used for treatment should not be left on the Hand-piece or Cartridge.
⚫ To avoid system damage, do not tilt the equipment and avoid collision with other
electrical devices.

ULTRAFORMER MPT Operation Manual | 10

 ⚫ The ULTRAFORMER MPT comes with a three-conductor AC power cable and plug. Use a
properly grounded outlet and always plug the ULTRAFORMER MPT directly into the
outlet.
Never remove the ground conductor via any AC adaptor plugs or extension cables.
⚫ Disconnect the AC Power cable from the outlet by pulling on the plug not the cord.
⚫ Do not touch the AC Power cable with wet hands.
⚫ Turn off the AC Power switch and disconnect the AC Power cable from the outlet prior
to cleaning the Main Body.

⚫ Do not remove the covers on the Main Body or Hand-piece. The ULTRAFORMER MPT
contains no user serviceable components. If the System requires service, contact local
distributors or Classys Inc.
⚫ No modification of this equipment is allowed.
⚫ The ULTRAFORMER MPT should not be used near flammable gases or anesthetics. Fire
or explosions may occur. The ULTRAFORMER MPT is not AP or APG rated.
⚫ Avoid restricting ventilation under or behind the Main Body of the system. Maintain an
open space of at least 50cm around the Main Body. If ventilation holes are obstructed,
the System may overheat.
⚫ The Hand-piece is rated as a Type B 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.
⚫ Use the Cartridge provided by Classys Inc. only. Operating with any other Cartridges may
cause patient injury or malfunction of the device.
⚫ Do not suddenly remove the Hand-piece from the Main Body. It may malfunction or
cause damage if separated by force.
⚫ Please refer to section “3-3-3” for warnings of Electromagnetic Compatibility and
Immunity”.

ULTRAFORMER MPT Operation Manual | 11

 3-3-2. Cautions
⚫ Do not turn on and activate the device without applying ultrasound transmission gel to

the Cartridge. This could cause damage to the Cartridge.

⚫ Do not apply the Cartridge to the skin without use of ultrasound transmission gel.
⚫ Before proceeding with treatment, check if the Cartridge is properly attached.
⚫ The Hand-piece connectors must be kept clean and dry. Do not use the Cartridge if the
connectors have been immersed in liquid. Refer to sub-section 7.1 of this manual.
⚫ The Hand-piece has been designed to be robust, however it may be damaged if dropped
onto a hard surface or if the membrane is punctured. If physical damage is incurred it
will not be covered by warranty.
⚫ Operators are advised to check the remaining shots of the Cartridge prior to treatment,
in order for the user to replace the Cartridge before depletion of the Cartridge. If
additional Cartridges are required, contact local distributors or Classys Inc.
⚫ Used cartridges should be disposed of in accordance with local regulations.
⚫ Please refer to section “3-3-3” for cautions of Electromagnetic Compatibility and
Immunity”.

Please follow the directions below if the system does not turn on:
⚫ Ensure the Main Power and key switch is in the ON position.
⚫ If the problem persists, unplug the Power cable.
⚫ Pull the fuse holder below the Main Power switch.
⚫ Replace the fuse (T10AH250V).
⚫ If the problem persists, please contact the local distributors or Classys Inc.

3-3-3. Electromagnetic Compatibility and Immunity

The RF emission of the "ULTRAFORMER MPT" meets the requirements of the safety
standard for medical equipment. Therefore, it causes almost no interference.
Its energy requirement is mainly commercial. However, a hospital installation is required
except for near active HF surgical equipment and the RF shielded room for a system of
magnetic resonance imaging, where the intensity of EM precautions is high.

ULTRAFORMER MPT Operation Manual | 12

 Warning: Use of “ULTRAFORMER MPT” adjacent to, or stacked with, other
equipment should be avoided because it could result in improper operation. If
such use is necessary, “ULTRAFORMER MPT” and the other equipment should be
monitored to verify that they are operating normally.

Warning: Use of accessories other than those specified may result in increased
emissions or decreased immunity of this system

Warning: Portable RF communications equipment (including peripherals such as

antenna cables and external antennas) should be used no closer than 30cm (12
inches) from any part of the ULTRAFORMER MPT, including cables specified by
Classys Inc. Otherwise, degradation of the performance of ULTRAFORMER MPT
could result.

Caution: The EMISSIONS characteristics of ULTRAFORMER MPT make it suitable

for use in industrial areas and hospitals (CISPR 11 class A).

Caution: The “ULTRAFORMER MPT” has been designed to meet the standards of
IEC60601-1-2 for electromagnetic compatibility; however, output can be lost or
degraded due to EM disturbances.

3-3-4. Environment
• Main (AC) power quality should be that of typical commercial or hospital
environments.
• Flooring should be wood, concrete or ceramic tile. If covered with synthetic material,
the relative humidity should be at least 30% to ensure that strong static electricity is
not generated.
• Service personnel trained by an authorized Classys Inc. provide regular service during
the life cycle of equipment to check the environment in terms of EM disturbance and
to maintain the safe use of the device.

ULTRAFORMER MPT Operation Manual | 13

3-4. Safety Symbols

No. Symbol Meaning

1 Type B applied Part

2 Alternate Current

3 Serial Number

4 Date of Manufacture

5 Manufacturer

6 Storage Temperature

7 Relative Humidity

8 Atmospheric Pressure Limits

9 Caution

10 General Warning, Caution, Risk of Danger

11 Mind instruction for use

12 Pushing prohibited

13 Sitting prohibited

14 Stepping prohibited

15 Crossed-out Wheelie bin

16 Protective Earth

ULTRAFORMER MPT Operation Manual | 14

4. Setting Up for First-Time Use
4-1. Unpacking
The Main Body, Hand-piece and Cartridges are shipped in one container.

4-2. Physical Environment

4-2-1. System Main Body
The device dimensions are shown in Figure 4.1. To maintain optional efficiency, sufficient
space should be allocated in accordance with the indicated installation space shown in
Figure 4.1. It is a general expected that external temperatures of the device will rise when
the device is used continuously and should be accounted for. System weight and
dimensions are additionally listed in “Specifications” (Refer to Section 8) of this User
Manual.

Figure 4.1. The required storage area for the ULTRAFORMER MPT

4-2-2. Electromagnetic Environment

The system is unlikely to cause interference to nearby electronic equipment; however,
other electronic equipment must not be stacked or placed immediately adjacent to the
System. The floor should be wood, concrete or ceramic. If floors are covered with
synthetic material, the relative humidity must be at least 30%

ULTRAFORMER MPT Operation Manual | 15

4-3. Connection to Components
4-3-1. Connecting the Hand-piece
The Hand-piece connector is located on the rear of the Main. Connect the Hand-piece
connector to the Main Body. If connected correctly, a clicking sound will occur.

4-3-2. Identifying and Connecting Cartridges

Cartridges are identified by the label on the side of the Cartridge which includes the name
of the Cartridge, treatment frequency and treatment depth.
Remove the Cartridge from its protective pouch. To connect the Cartridge, slide the
cartridge into the Hand-piece as shown in Figure 4.2. If connected correctly, a clicking
sound will occur.

Figure 4.2 Connecting the Cartridge Figure 4.3 Disconnecting the Cartridge

To disconnect the Cartridge, press the latch on up sides of the Hand-piece and slide the
cartridge straight out of the hand-piece. When the cartridge is inserted, the Main Body
automatically recognizes and updates the Graphical User Interface.

4-3-3. Device connection setup

Ensure the AC power cable connected from the back of the System is plugged into the wall
socket. For electrical safety, connect the external ground terminal of the device to a
separate ground terminal.

ULTRAFORMER MPT Operation Manual | 16

5. System Operation
5-1. Overview of System Functions
5-1-1. Operating Graphical User Interface (GUI)
An overview of this screen is seen in Figure 5.1 below.

Figure 5.1 Initial screen

5-1-2. Operating Graphical User Interface

When you select the Hand-piece, display screen is as shown Figure 5.2.

< ULTRA F > < ULTRA BOOSTER >

Figure 5.2 Setting screen

ULTRAFORMER MPT Operation Manual | 17

 No SIGN Description
Cartridge temperature display (normal / warning / error)

Wi-Fi signal strength(high/normal/ low/ disconnecting)

When the Error icon is touched in the screen, the popup

window came on. (not connected to the server/not
connected to the AP server/ not connected to the
internet/failed to license registration)
1
When problem occurs for the rear fan of device

When the error occurs for the SMPS

When and occur at the same time

When it’s estimated that there’s something wrong with

the output of HIFU

2 Remain shot of Cartridge

3 Display the installed Cartridge information.

4 Used shot of Cartridge

Display of available trigger sources.

5 -Hand / Foot / Foot switch disconnected
-Trigger pressed

Increase the output

Adjustable between 0.1~2.0J (depending on the Cartridge
6
energy) in increments of 0.1J.
Decrease the output

7 Treatment total shot of face Cartridge after system power on

Beeping sound reminds user that the total shot counter of face
8 Cartridge has been reached. Continuous shots may be applied
to a maximum of 9999.

Single application mode

9
Repeat application mode
After one shot, pause for a set time and then output the next
shot. (Pause time is 0.1~1 second)
Irradiation while moving by a set pitch during ultrasonic
output
10
When outputting ultrasound, irradiate at once without
stopping

ULTRAFORMER MPT Operation Manual | 18

 Increase the length.
11 Adjustable between 5~25mm in increments of 5mm.
Decrease the length.
Increase the pitch.
12 Adjustable between 1.0~2.0mm in increments of 0.1mm.
Decrease the pitch
Save the setting parameters to either M1, 2 or 3.
13 Save setting by holding the button down for 2-3 seconds.
Able to rewrite over existing saved parameters.

14 Setup button and Cartridge information button

Displays “READY” when in use, displays “STANDBY” when not

15
in use”

Display the currently used slot

16 (Hand-piece change button when automatic recognition
function “OFF” in Setup

5-1-3. Setup / Info GUI (Graphical User Interface)

When you select “Setup/Info” the display composition is shown as Figure 5.3.

< SETUP > < INFO >

Figure 5.3 Setup / Info GUI
No SIGN Description

1 Setting volume ( 0 ~ 5 )

Display of available trigger sources.

2 (Hand or Foot/ Only hand-piece button
/ Only Foot switch)
Hand-piece automatic recognition function ON /
3
OFF

ULTRAFORMER MPT Operation Manual | 19

 4 Animation function ON / OFF

5 Setting license, network, date

Lock screen setting and Password setting

-Setting the screen protection and usage
restriction if user do not use it for a certain
6
period of time.
-Password setting (The user need to know the
existing password to change it)
Reset factory
7
(Reset the memory and shot information)

8 Go to the main screen

9 Hand-piece type indication and shot clear button

Information of previously used Cartridges

10
Information of previous shot count from
Cartridges

11 Total number of shots used by hand-piece type

12 QR code for device information

5-2. Activating the System

5-2-1. Ensure the AC Power cable on the back of the System is plugged into the wall socket.
For the safety of patients, operators and electrical safety, connect the external ground
terminal of the device to a separate ground terminal in the room.

5-2-2. Ensure the Main Power Switch is in the ON position.

5-2-3. Press the power button to turn the System ON.

ULTRAFORMER MPT Operation Manual | 20

5-3. Treatment Steps
5-3-1. Set the parameters (Energy, Pitch, Length) manually for treatment by adjusting the
buttons on the GUI.

5-3-2. Ultrasound transmission gel should use previously registered sterile or non-sterile
medical gels by health authority.

5-3-3. Ensure the treatment area has been cleansed thoroughly.

5-3-4. Apply a thin layer of ultrasound transmission gel to the Cartridge. Use aqueous
ultrasound transmission gel only, as other lubricants or lotions may damage the
Cartridges or Hand-piece.

5-3-5. Select the “STANDBY” button on the GUI. Once selected it will change to “READY”.

5-3-6. Apply a thin layer of ultrasound transmission gel to the patient’s skin. Place the
Cartridge window on the patient’s skin and pull the trigger to emit ultrasound energy.

5-3-7. To deliver the next treatment line within the same treatment region, align the
Cartridge 2-3mm to adjacent tissue within the treatment area and pull the trigger to
emit ultrasound energy.

5-3-8. After 5 treatment lines are delivered, conduct a visual check of the Cartridge window
to assess if the gel needs to be reapplied.

5-3-9. Continue in this pattern until the recommended number of treatment lines for the
region has been delivered. A beeping sound will occur when the correct number of
treatment lines is delivered.

5-3-10. When treatment is complete on the target region, press the “READY” button.

5-3-11. Place the Hand-piece on the Hand-piece holder.

ULTRAFORMER MPT Operation Manual | 21

5-4. Shutting Down the System
5-4-1. Turn off the device by pushing the power button located on the Main Body.

5-4-2. The Main Power Switch on the rear of the Main Body should be OFF. The System may
be switched OFF when moving the equipment between rooms or for storage or
cleaning purposes.

5-4-3. Follow maintenance and storage instructions shown in Section 7 of this manual.

ULTRAFORMER MPT Operation Manual | 22

6. System Messages
The ULTRAFORMER MPT is designed with internal checks to ensure that all aspects of the
equipment are functioning appropriately. Please follow the instructions and refer to the
information listed below when errors occur.
No. Error Message Description Corrective Action

1. Ensure that the Hand-piece is

properly mounted in the Main body.
2. Turn the system “OFF”
E-01 Disconnected Hand-piece 3. Remove and reinsert the Hand-piece
4. Turn the system restart.
5. If the problem persists please contact
Classys Inc. support.

W-02 Calibration Fail

No 1. Ensure that the Cartridge is

Connection failure (Cartridge)
Cartridge properly mounted in the Hand-
piece.
2. Remove and reinsert the Cartridge.
3. Turn the system “OFF” and restart.
4. If the problem persists please
contact Classys Inc. support.

W-03 Motor Stall

W-04 Motor Moving error

ULTRAFORMER MPT Operation Manual | 23

 No. Error Message Description Corrective Action

E-05 Electronic Control error

1. Turn the system “OFF” and restart.

E-06 Fan error 2. If the problem persists please contact
Classys Inc. support.

E-07 Not Connected

1. Change the cartridge or Pause the

procedure until the temperature
Cartridge temperature error
inside the cartridge decreases.
2. Change the cartridge or Pause the
W-08 -Cartridge temperature is high
procedure until the temperature
inside the cartridge increases.
-Cartridge temperature is low
3. If the problem persists please contact
Classys Inc. support.

1. Pull the trigger switch only if the

system status is on “ready”.
W-09 Fire switch pressed
2. If the problem persists please contact
Classys Inc. support.

ULTRAFORMER MPT Operation Manual | 24

 No. Error Message Description Corrective Action

1. Ensure that the Footswitch is properly

mounted in the Main body.
2. Turn the system “OFF”
W-10 Footswitch disconnected 3. Remove and reinsert the Footswitch
4. Turn the system restart.
5. If the problem persists please contact
Classys Inc. support.

Restart the system. If the error reoccur,

E-11 Error the internal base board please contact your local distributor or
manufacturer.

Cartridge not recognized, please replace

E-12 Security rock of cartridge the
Cartridge.

Unplug the Wi-Fi dongle and plug it

Network Error ( WIFI dongle)
back in.
W-11 If it’s still the same, use another Wi-Fi
Check the WIFI Dongle and AP.
dongle
to check

Network Error (Internet)

Check WLAN operation in network
W-12 Cannot connect to the internet.
environment where Wi-Fi is connected.
Check the network connection
or settings. ( Network error ),

Network Error(Network)

W-13 Network connection is

unstable. Check the network
settings.
Check the network settings and contact
Network Error(Server) customer service if there is no problem

Cannot connect to the server. If

W-14
the error reoccurs, please
contact your local distributor or
manufacturer.

ULTRAFORMER MPT Operation Manual | 25

7. Cleaning and Storage
7-1. Cleaning the Main Body, Hand-piece and Cartridge
System is Main body, Hand-piece and Cartridge. When cleaning system surfaces, apply
the recommended cleaning method and solution. Be careful when cleaning the hand-
piece and cartridge. Cartridges are packaged and shipped non-sterile and ready to use.
Step Main body Hand-piece Cartridge
1. Turn off the system
2. Unplug the system from the electrical outlet
Common
3. Tester should wear gloves and masks.
4. Do not reuse materials used for reprocessing.
Before 1. Cleaning 1. Cleaning
device use ① Clean the visible contaminants on the main ① Clean each visible
body and hand-piece surfaces with new Cotton contaminant from the
cloth. Cartridge with a new Cotton
② Once before treatment after moving to the Cloth.
treatment room ② If contaminants have not
been removed from the skin
contact surface of the
cartridge, manually shake
the skin contact surface of
the cartridge in clean water
for 1 minute and dry the
moisture completely with a
new cotton cloth.
③ Clean Before and after
treatment
2. Disinfection 2. Disinfection
① Wipe for more than a minute with a new ① Wipe for more than a
cotton pad soaked enough in all parts with minute with a new cotton
isopropyl alcohol (70%). pad soaked enough in all
② Dry naturally so that all isopropyl alcohol is parts with isopropyl alcohol
evaporated on the surface of the device. (70%).
③ Inspect the cartridge for damage such as ② Dry naturally so that all
cracks, corrosion, discoloration, or water isopropyl alcohol is
leakage. If damage is evident, discontinue use evaporated on the surface
and contact the manufacturer. of the device.
④ Perform the disinfection once before ③ Perform the disinfection
treatment after moving to the treatment room once before and after each
procedure
After device 1. Cleaning 1. Cleaning
use ① Clean the visible contaminants on the main ① Clean each visible
body and hand-piece surfaces with new Cotton contaminant on the
cloth. Cartridge surface with a
② Wash every 10 to 15 days for long-term new cotton cloth.

ULTRAFORMER MPT Operation Manual | 26

 Step Main body Hand-piece Cartridge
storage. ② If contaminants are not
removed from the skin
contact surface of the
cartridge, manually shake
the skin contact surface in
clean water for 1 minute and
dry it completely with a new
cotton cloth.
③ Wash every 10 to 15 days
for long-term storage.

Warning: Be careful not to let isopropyl alcohol enter the drain hole due to
careless handling of the isopropyl alcohol container. Excess amounts of isopropyl
alcohol can cause soil, surface or groundwater contamination.

7-2. General Care of the System

To achieve a longer lifetime and use of the ULTRAFORMER MPT, treat the equipment
carefully by adhering to the following guidelines:
⚫ Inspect the Hand-piece and Cartridges regularly for any issues.
⚫ Turn the device off before changing Cartridges to ensure proper identification of
Cartridges and to prolong the life of the System.
⚫ Do not drop the Hand-piece or Cartridges on the floor or other hard surfaces. This may
cause permanent damage.
⚫ Do not twist or pull the hand-piece cables. This could cause damage to internal wires
and connections.
⚫ Use aqueous ultrasound transmission gel only. Other lubricants or lotions, particularly
mineral oil, may damage Cartridges or the Hand-piece.
⚫ Do not use acoustic standoff pads or any objects between the Cartridge and the patient.
⚫ Apply ultrasound transmission gel only to the window of the Cartridge and wipe it from
the Cartridge after completing a session of treatment. Avoid the gel from contact with
the Hand-piece or the Main Body.
⚫ Cartridges should be cleaned between procedures. Refer to the cleaning procedure
information allocated in subsection 7-1.

ULTRAFORMER MPT Operation Manual | 27

7-3. Movement, Storage and Disposal
7-3-1. Movement
⚫ Handle the ULTRAFORMER MPT with caution at all times.
⚫ Unlock the Main Body casters and using the knob, move the equipment to the
desired site.

7-3-2. Storage
Avoid direct sunlight and/or excessive moisture, wind and dust. Also keep away from
the heater. Never let the gel remain in the connection between the hand-piece and
cartridge. Store the cartridge in the packaging or in the cartridge holder in the main
body.

⚫ Temperature: 5℃ - 60℃

⚫ Relative Humidity: 0% - 90%

⚫ Air Pressure: 500hpa - 1060hPa

7-3-3. Disposal of old Electrical & Electronic Equipment (WEEE)

(Application in the European Union and other European countries with separate collection
system.)
⚫ Electric and electronic equipment must not be disposed of together with household
waste.
⚫ The user is obligated to dispose of a broken redundant electrical or electronic device
at a dedicated collection location and put it in a special container.

The details are set forth based on the relevant national laws. The obligation is
indicated on the product label or in the manual in the form of a crossed-out waste
bin. By sorting waste for recycling, you help to protect the national environment.

7-4. License and Software management

7-4-1. License management

ULTRAFORMER MPT Operation Manual | 28

 1) Warning of pop-up in license expiration
To use ULTRAFORMER MPT, it should be registered a license by Classys, and when
the renewal of license is close to expiration, the pop-up window is generated as
follows.

2) The screen of license renewal (automatic)

<Set up> <The screen of license renewal (automatic)>

① Touch the Manage License button on the screen, it moves on to the screen of license
management.

② -1. The expiration date on this license is displayed on the screen of license renewal
(automatic) and the warning sign is given to user such as following color.
- License expires soon. :

- License expires. :

③ -2. Display the equipment serial number

ULTRAFORMER MPT Operation Manual | 29

 ④ -3. ON/ OFF the renewal of license

3) The screen of license renewal (manual)

③

①
②

① To issue the license code, touch the button for requesting the license code.

② When entering the issued license code, touch the button on the screen.

③ It generates the code, the code is displayed as shown in Figure ③.

④ To insert the license code on the screen, an IME (input method editor) window should be
generated and then user can input the license code as in Figure ④.

7-4-2. Software management

1) The screen of Software management

① The software version is displayed on the screen.

② It displays the serial number of this software.

ULTRAFORMER MPT Operation Manual | 30

 ③ Check the latest software and update it as follows.

- Searching for the latest updated of software

-If the current version of software is the latest version, it is displayed as shown below. If
needed the latest update, go to the update screen.

2) Screen of software update

① Displays the latest version of software.

② Touch the “download” button when downloading and installing the latest version of

software.
- Generate the progress bar during the download : When downloading the update of
software, the user can check the current status.

- Generate an install button when the download is complete: When the download is
completed, the user can touch the “install” button, and install the update file on the
main

ULTRAFORMER MPT Operation Manual | 31

 7-4-3. Time/ Date setting

① Move the setting the time zone

② Display the setting date/ time

③ ON/ OFF the summer time

- Displayed by adding 1 hour to the existing time when activated

- Show existing time when deactivated

7-4-4. Network setting

1) Network setting screen

① ON/ OFF the WIFI

② Refresh the WIFI list

ULTRAFORMER MPT Operation Manual | 32

 ③ Connected WIFI

- Place it at the top.

- Wi-Fi reception strength / security icon
- Disconnect button
- Detail information button

④ WIFI list

- Place the connection signal in the order of strong.

- Wi-Fi reception strength / security icon
- Connection button
: For security reasons, the password IME appears.
- Details button

⑤ Add the other network

2) WIFI information screen

① Status the WIFI connection

② WIFI address

③ WIFI information display

-IP address, Subnet Mask, Router

3) Add the other network

ULTRAFORMER MPT Operation Manual | 33

 ① Display the error marking

② Input the WIFI name: Input method editor(IME) appears when input is made.

③ Input the WIFI password: Input method editor(IME) appears when input is made.

7-4-5. Software management

1) Software management screen

① Software version

② Serial number

③ Check the software update

ULTRAFORMER MPT Operation Manual | 34

 -Installing the latest update

-If the current version is the latest version, it is displayed as follows.

2) Software update screen

① Display the latest software version

② Download and install the latest software

-Create a program bar when downloading.

-Create the install button when download completed

7-4-6. Recommended Specification of WIFI LAN Dongle

1) Wireless standard: IEEE 802.11n/b/g

ULTRAFORMER MPT Operation Manual | 35

 2) Power: USB Power
3) Interface: USB 2.0, Type-A
4) Wireless RF: 2.4GHz, 5GHz
5) Maximum size that can be installed: less than 50mm(W) x 20mm(H) x 8mm(D)
6) Usable CHIPSET LINUX Driver

Realtek 8188eu,8188fu,8192eu,8192su,8812au,8821cu,8822bu

Mediatek mt7610,mt7612
7) Please purchase and use a wireless LAN using a supported chipset.
8) If it is difficult to confirm whether the model you want to purchase is applicable, please
contact the service team.

8. Specifications
8-1. Specifications Table

No. Item Specification

1 Product Name Focused Ultrasound Therapeutic Equipment

2 Brand /Model Name ULTRAFORMER MPT, UF4-M400

3 Output 0.1J – 2.0J

4 Pitch 1mm - 2mm

5 Length 5mm - 25mm

6 Display 10.4 Inch LCD touch screen

7 Electrical Requirement 100 - 240V~, 50/60Hz

8 Electric power consumption 400VA

9 Type and degree of protection

Class I, Type B
against electrical shock

10 Dimension 570(L) X 630(W) X 1330(H) mm

11 Weight 37kg

ULTRAFORMER MPT 1.5/ ULTRAFORMER MPT 2.0

Cartridge
12 ULTRA F ULTRAFORMER MPT 3.0 /ULTRAFORMER MPT 6.0
(Optional)
ULTRAFORMER MPT 9.0 /ULTRAFORMER MPT 13.0

ULTRAFORMER MPT Operation Manual | 36

 ULTRA DERMA BOOSTER 1.5/ CELL UP BOOSTER 3.0
BOOSTER / LINE UP BOOSTER 4.5

[Operating Environment]
- Temperature: 10℃ - 35℃
- Relative Humidity: 0% - 90%
- Air Pressure: 700hpa - 1060hPa
13 Environmental
[Shipping and Storage]
- Temperature: 5℃ - 60℃
- Relative Humidity: 0% - 90%
- Air Pressure: 500hpa - 1060hPa

ULTRAFORMER MPT Operation Manual | 37

Appendix A. Electromagnetic Emissions and Immunity
Manufacturer’s declaration - electromagnetic emission
The ULTRAFORMER MPT is intended for use in the electromagnetic environment specified below. The customer
or the user of ULTRAFORMER MPT should assure that it is used in such an environment
Emission test Compliance Electromagnetic environment - guidance
The ULTRAFORMER MPT uses RF energy only for its internal function.
RF emissions
Group 1 Therefore. Its RF emissions are very low and are not likely to cause any
CISPR 11
interference in nearby electronic equipment
RF emissions
Class A
CISPR 11
The ULTRAFORMER MPT is suitable for use in all establishments other
Harmonics emission
A than domestic and those directly connected to the public low-voltage
IEC 61000-3-2
power supplies buildings used for domestic purposes.
Voltage fluctuation
Complies
IEC 61000-3-3

Manufacturer’s declaration - electromagnetic immunity

The ULTRAFORMER MPT is intended for use in the electromagnetic environment specified below. The User or
Licensee of the ULTRAFORMER MPT should assure that it is used in such an environment.

Electromagnetic
Immunity test IEC 60601 Test level Compliance level
Environment -guidance

Floors should be wood, concrete or

Electrostatic
8 kV Contact 8 kV Contact ceramic tile. If floors are covered with
discharge (ESD)
15 kV Air 15 kV Air synthetic material, the relative
IEC 61000-4-2
humidity should be at least 30 %
2kV for 2kV for
Electrical fast Mains power quality should be that
power supply lines power supply lines
Transient / burst of a typical commercial or hospital
1kV for 1kV for
IEC 61000-4-4 environment.
input/output lines input/output lines
1 kV 1 kV Mains power quality should be that
Surge
differential mode differential mode of a typical commercial or hospital
IEC 61000-4-5
2 kV common mode 2 kV common mode environment.
Power frequency Power frequency magnetic fields
(50/60Hz) should be at levels characteristic of a
30 A/m 30 A/m
Magnetic field typical location in a typical
IEC 61000-4-8 commercial or hospital environment.

ULTRAFORMER MPT Operation Manual | 38

The ULTRAFORMER MPT is intended for use in the electromagnetic environment specified below. The User or
Licensee of the ULTRAFORMER MPT should assure that it is used in such an environment.
Electromagnetic
Immunity test IEC 60601 Test level Compliance level
Environment -guidance
0% Uт 0% Uт
(100% dip in Uт) (100% dip in Uт)
for 0.5cycle (at 0, 45, for 0.5cycle (at 0, 45,
90, 135, 180, 225, 270 90, 135, 180, 225, 270
and 315) and 315)
Mains power quality should be that of a
Voltage dips, short
typical commercial or hospital
Interruptions and 0% Uт 0% Uт
environment. If the user of the
Voltage variations (100% dip in Uт) (100% dip in Uт)
ULTRAFORMER MPT requires continued
on power supply for 1cycle for 1cycle
operation during power mains
input lines
interruptions, it is recommended that the
IEC 61000-4-11 70% Uт 70% Uт
ULTRAFORMER MPT be powered from an
(30% dip in Uт) (30% dip in Uт)
uninterruptible power supply or a battery
for 25 cycle (at 0) for 25 cycle (at 0)

0% Uт 0% Uт
(100% dip in Uт) (100% dip in Uт)
for 250 Cycle for 250 Cycle

3V 3V
150 kHz to 80 MHz 150 kHz to 80 MHz
Conducted RF
6 V in ISM bands 6 V in ISM bands -
IEC 61000-4-6
between 0,15 MHz between 0,15 MHz
and 80 MHz and 80 MHz

Recommended separation distance

Radiated RF
3 V/m 3 V/m
IEC 61000-4-3 Where P is the maximum power in W, d is
80.0 MHz to 2.7 GHz 80.0 MHz to 2.7 GHz
the minimum separation distance in m, and
E is the
IMMUNITY TEST LEVEL IN V/m.
Note 1) Uт is the A.C. mains voltage prior to application of the test level.
Note 2) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land
mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with
accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey
should be considered. If the measured field strength in the location in which the EUT is used exceeds the applicable
RF compliance level above, the EUT should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as re-orienting or relocating the EUT.

ULTRAFORMER MPT Operation Manual | 39

OPERATION MANUAL (Ver. 1.0, November. 2023)

Classys Incorporation
UF4M1023IL

Head Office
Classys, 208, Teheran-ro, Gangnam-gu, Seoul, Republic of Korea.
Factory
A-1501~1515, 15F/ A-801~815, 8F/ B-701~715, 7F, H Businesspark, 25, Beobwon-ro 11-gil, Songpa-gu,
Seoul, Republic of Korea.
Tel: +82-2-517-2114 Fax: +82-2-6008-3457
Homepage: [Link] E-mail: info@[Link]

ULTRAFORMER MPT Operation Manual | 40