2 / 43 ilooda co.,ltd - msc medical · 7 / 43 ilooda co.,ltd chap. 2 introduction to multiple iris...

2 / 43 ILOODA CO.,LTD

The copyright and all publication rights for this manual are owned by ILOODA Co., Ltd.

Any part of this user manual must not be modified, reproduced, or copied without prior permission of ILOODA Co.,

Ltd. (Hereafter referred to as ILOODA)

ILOODA has the right to alter the technical specifications and/or configuration of the apparatus to enhance its

performance, reliability or production capability in its discretion without any prior notification.

Exemptions

The information provided by ILOODA is correct and reliable.

However, ILOODA doesn’t take any responsibility for the damage caused by using the equipment for different

purposes other than original ones presented in this user manual.

ILOODA CO., LTD. (Manufacturing Company)

Address: #801~805 Venture Valley, 958 Gosaek-Dong, Gwonseon-Gu, Suwon City, Gyeonggi-Do, Korea

Tel: +82-31-278-4660

Fax: +82-31-278-4661

Website : www.ilooda.com , E-Mail : [email protected]

Please check the related local regulations before using the equipment. The use of the apparatus may not be

permitted if it is not in conformity with the related local law.

http://www.ilooda.com/

mailto:[email protected]


Table of Contents

Chapter 1 Overview

1. Apparatus-verification Data

2. Items Provided

3. How to Use This User Manual

Chapter 2 Introduction to MULTIPLE IRIS

1. Introduction to MULTIPLE IRIS

2. Qualification for Using MULTIPLE IRIS

3. Essentials for Using Equipment

3.1 Installation of Equipment

3.2 Patient and Cautions

3.3 Eye Protection

3.4 Setting of Equipment

Chapter 3 Safety Cautions

1. Cautions for Safe Use of Laser Equipment

1.1 Optical Hazard

1.2 Electrical Hazard

1.3 Fire Hazard

2. Cautions for Safe Use of Equipment

2.1 Cautions for Product Safety

2.2 Cautions before Use

2.3 Cautions during Use

2.4 Cautions after Use

2.5 Cautions in Storage

2.6 Cautions for Maintenance

3. Labeling


Chap. 4 How to install the equipment

1. Description of the equipment

1.1 Description of the equipment’s exterior structure

1.1.1 Description of the main unit

1.1.2 Description of the hand piece

1.1.3 Description of the accessories

1.2 Installing the equipment

1.2.1 Installing the main unit (power part)

1.2.2 Installing the main unit (532/940 hand piece)

1.2.3 Installing the main unit (532/940 hand piece)

1.2.4 Installing the main unit (scanner hand piece)

Chap. 5 How to use the equipment

1. How to use for each mode

1.1 How to turn power on/off and use the main screen

1.2 How to use 532 / 940 normal modes

1.3 How to use 532 / 940 fractional modes

2. How to use the hand piece

Chap. 6 Equipment parameters

1. Energy formula per unit area

2. The amount of energy for each spot size

3. Specification sheet

Chap. 7 Description of error messages


1. Equipment’s specification

1.1 Electrical specification

1.2 Mechanical specification

2. Mentioned items


Chapter 1 Overview

1. Apparatus-verification Data

Product Name : Medical Laser Equipment

Model Name : MULTIPLE IRIS

Manufacture Serial Number :

Date of Manufacture :

2. Supplied Items

This equipment is comprised of the following components (accessories.)

Main unit and hand pieces (532nm hand piece / 940 hand piece / scanner hand piece)

Power cable

User goggle (goggle for doctors - 532nm)

Eye guard for patients

Remote interlock contactor

Foot switch & cable

Power key

Handimate Cleaner (fiber cleaning paper)

User manual

Option

Equipment cart (option)


3. How to Use This User Manual

Purpose of This User Manual

The purpose of this manual is to make users be fully aware of the structure, installation,

manipulation, operation, and maintenance of MULTIPLE IRIS Laser System.

Keeping of This User Manual

This manual must be kept together with the equipment or near the equipment so as that you can

refer to it if necessary.

Expressions Used in This User Manual

The expressions Caution, Note, and Warning as below are used in this manual.

Note

‘Note’ tells the problem related with the improper use of the equipment as well as warns the user

about the possibility that some trouble occurs due to the problem. These problems include the

damage to other related property as well as the poor operation of the system. This expression

involves the matters to take a full note to avoid this harm.

Warning

‘Warning’ warns the user about the possibility of improper use of the system and of injury, death, or

serious side effects.

Please check the related local regulations before using the equipment. The use of the apparatus may

not be permitted if it is not in conformity with the related local law.

This equipment is a system applicable to various wavelengths such as 532, 940nm, which the

system corresponding to the option may not be mentioned on this manual, and the performance and

screen menu may be different depending on the hand piece’s option


Chap. 2 Introduction to Multiple IRIS

1. Introduction to Multiple IRIS

Multiple IRIS is an equipment to induce efficient treatment for blood vessels, pigment, and various

skin diseases by delivering energy of 532nm laser / 940nm laser and scanner laser, mounting a scanner

on a hand piece, to skin in combination.

Diode laser of 532/940nm has high absorptivity for hemoglobin tissues.

High absorptivity for hemoglobin allows blood vessels are heated up to clinical reaction temperature by

even small incident energy, so that it is very effective to treat epidermal blood vessels between 50 and

200um, and can minimize damages of adjacent tissues due to excessive energy use.

The 532nm laser can output light with pulse widths of continuous and pulse modes (10ms~400ms,) it is

very effective for

Epidermal blood vessel diseases (Telangiectasia, Sider Nevi, Rosacea, Angiomas)

Benign pigment diseases (Lentigines, Freckles, Naevi, Xanthelasma)

Skin-stimulating effect (Skin Rejuvenation)

It can bring about much progress of improvement for skin treatment.


2. Qualification for Using MULTIPLE IRIS

It is strictly required that this equipment be used only by the doctor qualified for safety handling and use

of laser apparatus. Thus any persons concerned (nurses etc.) except for a doctor holding a license or a

certificate on laser device must not use this equipment.

It is recommended that all the relevant people (nurse etc.) including medical staffs complete the training

on installation procedure, operating method and potential hazards of laser equipment, laser physics, and

interactions of tissues and take the respective safety education program according to each country’s

regulation in addition to laser-related safety education.

It is also recommended that the doctor wanting to use the laser equipment obtain an approval required

for using it from the relevant authorizing organization in the country.


3. Essentials for Using Equipment

The following instructions are the essential guidelines to be surely considered before using the equipment.

In case that you don’t observe them, the critical damage like the performance degradation of the

equipment can be brought about.

3.1 Installation of Equipment

The equipment must be installed and used only in a safe treatment room of hospital.

The use of the equipment in other places (i.e. skin care shop, other treatment place etc.) except

hospitals is strictly prohibited.

The equipment should be moved and installed only in a state of turning-off and placed in a safety

flat space.

The power and system specifications must be checked in installing the equipment and the

‘installation’ section in this manual should be referred to for proper setting of the each laser

connector in installing the laser connectors.

3.2 Patient and Cautions

Make sure to give the treatment only to the patient in accordance with the purpose of this equipment

after the doctor’s prior diagnosis. The treatment to the patient with other lesion, not with the

originally targeted one without the doctor’s prior diagnosis is strictly prohibited.

Before treatment, make sure to check the patient’s skin state and sterilize the region to be treated so

as that there are no foreign substances.

Before treatment, remind a patient of the cautions before, during, and after treatment and notify the

possibility of occurrence of unintended abnormal symptoms to him or her.

3.3 Eye Protection

All of the persons around the laser equipment in use (doctor, patient, nurse and other supporting

staffs) must wear the appropriate eye protection tools.

Never take a direct look at the laser tip.


3.4 Setting of Equipment

Set the parameter values in consideration of the patient’s state before setting the equipment.

The setting of the equipment must be conducted in standby mode and the handpiece should be put

in a safe place (handpiece holder) with the laser radiation part downward when the equipment is set.

Increase using amount and intensity gradually from a small value to the desired value when

adjusting the setting values.

Abide by all the safety-related cautions stated in this manual.

Never adjust the equipment at the user’s (doctor’s) discretion with other adjusting

method different from the method stated in the manual.

Do not make the laser system used by a non-qualified person without the

supervision of a trained and experienced specialist.

Place the handpiece in a stable location and keep the direction of the handpiece

away from other people than patient.

All of the persons around the treatment must wear the eye protection tools

(goggles and eye guards) and must not take a direct look at the laser tip or

reflected ray. It may bring about permanent damage to eyes.

When you are to change the setting values, always check the displayed contents

on the screen first to see if the application parameters are correctly set.

Patient and operator (doctor) should not carry the metallic materials such as rings,

watches, necklaces etc.

Use the equipment only onto the skin surface in which there are no infection and

other damage.

Never use the equipment for treatment of different purpose other than original

purpose.

Make sure to turn off the equipment and pull out the key not to be operated by

others when it is not used or even an operator (doctor) leaves for a moment.

The SMA connector and holder of the main unit and hand piece must be covered

with the protective cap to store after use.

Never disassemble the equipment. The disassembly of the equipment can be

carried out only by an authorized repair person of the manufacturer. It is

impossible for the equipment to conduct the laser treatment in a situation when it

is disassembled.


Chapter 3 Safety Cautions

1. Cautions for Safe Use of Laser Equipment

1.1 Optical Hazard.

Laser wavelength in the visible ray range carries the hazard that can damage to the retina unless

you conform to the safety cautions.

The eye protective glasses for patient should be opaque and not pass any light

through them. In occurrence of an accidental radiation of laser, the patient goggles

should not reflect light or not conduct heat. Use the patient eye guards provided with

this equipment. When the laser light is visible to your sight, stop using the laser

equipment immediately and check if the protective glasses are damaged or

inappropriate.

All of the persons in a treatment room should wear the laser goggles protective against the laser

wavelength radiated from this equipment. Do not take a direct look at the tip from which the laser

is radiated, even when you are wearing the laser goggles.

There are various different types of laser goggles. Wear the goggles made suitable

for each wavelength (color).

Put the handpiece tip downward all the time and keep the handpiece in the handpiece holder.

When the treatment comes to a halt or stops, put the system into the standby mode or turn off the

system, and make sure to take the laser goggles off only after the shutdown of the system. Post up

a warning label for laser radiation on the outside of a treatment room and have all the staffs of a

hospital well-informed of the proper laser use protocol.

1.2 Electrical Hazard

All the users of the equipment should read and observe the following cautions for electrical safety,

or electric shocks may take place.


Do not touch any part carelessly except the operating part of the system.

Turn off the system or remove the plug when executing the ordinary jobs like connecting or

removing the laser applicator.

Make sure to use the laser system only in a place where there is electric

installation, obeying the standards and regulations of each region.

Do not use water or other liquid solvents when cleaning electrical parts. Prevent

water or other liquid from spilling it on the laser system.

Install with care not to fall down on electric wires and pipes or to entwine electric

wires.

Make sure to install and use the proper parts and accessories and do not use the

different products from the accessories provided along with the equipment.

Check the damage to the external appearance and electric wires of the equipment

on a regular basis.

1.3 Fire Hazard

All the users of the equipment should read and observe the following cautions for fire hazard, or

fire may take place.

Do not put the flammable or combustible materials or substances around the

treatment room.

If you use alcohol to clean the laser tip or handpiece tip, wait up to the time when

it is completely evaporated and dried before operating the system.

Do not radiate the laser to any part except for the part to be treated.

Avoid the hair, clothes, fabrics or other foreign substances that may work in

reverse with the laser and absorb it.

Cut off the power immediately in case of fire.

Only use a CO2 or powder extinguisher in case of fire.


2. Cautions for Safe Use of Equipment

2.1 Cautions for Product Safety

The owner and user of the laser system are obliged to obey all of the equipment-related safety

cautions. The following cautions related with the equipment must be observed.

Use this stimulating system only for the designated purpose.

Use the equipment only when it operates normally (There should not be an error

message).

Manage this manual and all other related materials always in a good condition and

keep them in a place where the laser equipment is installed to use them at any time.

Make the stimulating equipment operated, maintained and repaired only by a qualified

and authorized person.

Do not remove or erase the safety cautions and warning message attached to the laser

system.

Do not give a shock to the equipment.

The SMA connector and holder of the main unit and hand piece must be covered with

the protective cap to store after use.


2.2 Cautions before Use

I. Make sure to read the instructions and use the equipment before using it.

II. Make sure to use the equipment on a doctor’s prescription.

III. Do not connect the power on with a wet hand.

IV. Be careful not to spill water into the main body. It can cause the damage to the equipment and the

fire and electric shock.

V. Do not install the equipment in a watery, humid place. It can cause the damage to the equipment

and the fire and electric shock.

VI. Install the equipment at least a 100mm distance from the wall.

VII. Be careful not to make the power cord pressed by heavy weights or touched by sharp materials.

The use of a damaged cord can cause fire or electric shock.

VIII. Never use the equipment near flammables. It can cause the deformation of the main body, the

failure in the system, and the fire.

IX. Make this machine used only a professionally trained person.

X. Conduct a prior check on the manipulation of the system.

XI. Check the switches etc. and then confirm the correct operation.

XII. Connect all the cords accurately not to break away easily.

XIII. When you use the equipment after a long interval, confirm if it operates normally and safely or

not.

XIV. Never disassemble or change the equipment by anybody except by an installation and repair

technician. It can cause fire or electric shock.


2.3 Cautions during Use

I. Make sure to wear the operator’s goggles and patient’s eye guards.

II. Remove all the interruptions around the equipment when it is used. Do not put papers or other

materials on the top of the machine and block the vent.

III. When the failure in the system takes place, stop using it, and turn off the power and then contact

our customer service center.

IV. In case of a power outage, turn off the power immediately and put the controlling knob and

switches back to the original position.

V. Do not use the equipment near a patient monitor.

VI. Always check if there are some abnormalities on the patient and the equipment during use. If

some abnormalities occur on the patient or the equipment, check the patient’s safety and stop the

equipment. When you confirm that the patient and the equipment have no problems after check-

up, continue to use it again.

VII. Do not make anybody contact the machine except the patient and the doctor.

VIII. Make the laser beam not radiated directly toward the other people.

IX. Do not smoke while the laser light is emitted.

X. Do not look at the laser light reflecting from a reflector or flashing directly at your eyes.

XI. Be careful not to install the power cord of another machine at the same time. It can cause the

performance degradation of the equipment.

XII. Do not operate the machine in a place where chemicals are stored or gas is generated.

XIII. Do not pull the cord of the main body by force. It can cause the performance degradation of and

the trouble with the machine.


2.4 Cautions after Use

I. After use, put the control knob and switches back to the original position and turn off the power.

II. Be careful not to give an excessive force to the connecting part of cords when you pull out the

cords.

III. Make sure to turn off the power and take out the key so that other people cannot operate the

equipment.

2.5 Cautions in Storage

I. Do not keep the equipment in a place where there is some slope, shaking, or possible impact. It

can cause the performance degradation of the machine or the fire and electric shock.

II. Do not keep the equipment in a place where chemicals are stored or some gas is generated.

III. Do not keep the equipment in a place where temperature, air pressure, humidity, ventilation,

sunlight, and air containing dust, salt and sulfur have a harmful influence on it.

IV. Keep the equipment in a place far from water.

2.6 Cautions for Maintenance

I. In case of the trouble with machine, make sure to stop using it and contact the store you

purchased from or the customer service center.

II. Never open the machine and the controller.

III. Do not give an impact to the main body. If there had been some impact on it, make sure to use the

equipment after check-ups.


3. Labeling

The following safety labels must be attached to the equipment. Do not remove or change the labels

attached to the equipment at your own discretion.

RADIATION Label: Attached to the back of the main body

“LASER RADIATION” means that this laser equipment is classified as the Class 4 laser

product.

ID Label: Attached to the back of the main body

The product & model name and the required labeling by Medical Device Act are written

on this label.

Warning label for laser radiation: It is attached to the irradiation part of hand piece

and the connector of main unit, and it means recognition and caution of laser

radiation and application

(Laser radiation warning) (Laser application)


Emergency Stop Label: Attached to the right of the front side (near Emergency Stop

Button) in the main body

This label means the immediate stop of the laser in emergency situations.

STOP


Chap. 4 How to install the equipment

1. Description of the equipment

A. Description of the equipment’s exterior structure.

i. Description of the main unit

Front

A

B

C

D E G H F

I

J

K

L

M


A. LCD monitor: Touch panel for operating this equipment and displaying all information

B. Key switch: Main power switch to turn this equipment on/off

C. Emergency stop switch: Emergency button to immediately stop laser radiation in case of

emergency

D 940 hand piece SMA connector: Laser fiber incident connector

E. 940 hand piece signal connector: Fiber recognition connector (only for 940)

F. 532 hand piece SMA connector: Laser fiber incident connector

G. 532 hand piece signal connector: Fiber recognition connector

H. 532 scanner hand piece signal connector: Scanner recognition connector

I. 532/940 hand piece holder: Cradle to hold the hand piece

J. 532 hand piece: Hand piece to irradiate laser of 532nm

K. 940 hand piece: Hand piece to irradiate laser of 940nm

L. Scanner hand piece holder: Cradle to hold the scanner hand piece

M. Scanner hand piece: Hand piece to use for irradiating laser over wide spot


Rear

N. Power cord connector: Connector to connect the main unit with the power cord

O. Foot switch connector: Connector to connect the main unit with the foot switch

P. Remote interlock connector: Connector to connect the main unit with the remote interlock

Q. Ventilator: Ventilator to emit heat from the equipment

R. Equipment update port: Connector to connect the USB when upgrading the equipment

Q

O P N R


1.1.2 Description of the Hand piece

532nm Hand piece

a. Spot adjust knob: Knob to adjust spot size and

focus

b. Laser irradiation part: Part to irradiate laser

c. SMA holder: Laser fiber incident part

d. Signal connector: Recognizing fiber and spot

size

1450nm Hand piece

e. Laser irradiation part: Part to irradiate laser

f. Guide bar: Bar to focus laser

g. SMA holder: Laser fiber incident part

Scanner hand piece

i. Laser irradiation part: Part to irradiate laser

j. Signal connector: Recognize and control scanner

k. SMA holder: Laser fiber incident part

a

b c

d

e

f

g

i

j

k


1.1.3 Description of the accessories

The following are components (accessories) comprising of this equipment.

Power cable - Power key

User goggle (goggle for doctors - 532nm) - Eye guard for patients

Protective cap for main unit’s SMA connector - Remote interlock

Foot switch & cable - Handimate Cleaner (Fiber cleaning paper)

User manual - Equipment cart


1.2 Installing the equipment

1.2.1 Installing the main unit (power part)

(Refer to the rear image and numbering of ‘1.1.1 Description of the main unit.’)

1) Connect the power cable to the power cord connector (N) on the rear of main unit.

2) Insert the remote interlock into the remote interlock connector (P) on the rear of main unit.

3) Connect the foot switch to the foot switch connector (O) on the rear of main unit.

The foot switch and the remote interlock are distinct

by their colors for preventing confusion of each

connector. Insert them into the connector with the

same color as the arrow direction.


1.2.2 Installing the main unit (532nm hand piece)

(Refer to the image and numbering of the front of ‘1.1.1 Description of the main unit’ and ‘1.1.2

532nm hand piece.’)

1) Connect the hand piece’s signal connector (d) to the main unit’s signal connector (F)

horizontally as the arrow direction.

2) Remove the protective cap of the main unit’s SMA connector (F.)

3) Remove the protective cap of the hand piece’s SMA holder (c.)

4) For there is no impurity on the fiber of hand piece’s SMA holder (c,) clean the fiber by the

fiber cleaning paper. (Refer to the description of fiber cleaning paper.)

5) Insert the hand piece’s SMA holder into the main unit’s SMA connector horizontally, and then

rotate it clockwise to connect them tightly.

When inserting the SMA holder horizontally,

insert it carefully. It is possible that the fiber can

be damaged.

If the SMA holder is not tightly connected with the

main unit, it may cause a failure due to power

decline of laser and fiber damages.

For there is no impurity on the fiber of the hand

piece’s SMA holder, make sure to connect it after

cleaning. It may cause a failure.


1.2.3 Installing the main unit (scanner hand piece)

(Refer to the image and numbering of the front of ‘1.1.1 Description of the main unit’ and ‘1.1.2

Description of the scanner hand piece.’)

1) Connect the hand piece’s signal connector (j) to the main unit’s scanner hand piece signal

connector (H) horizontally as the arrow direction.

2) Remove the protective cap of the main unit’s SMA connector (F.)

3) Remove the protective cap of the scanner hand piece’s SMA holder (k.)

4) For there is no impurity on the fiber of hand piece’s SMA holder (k,) clean the fiber by the

fiber cleaning paper. (Refer to the description of fiber cleaning paper.)

5) Insert the hand piece’s SMA holder into the main unit’s SMA connector horizontally, and then

rotate it clockwise to connect them tightly.

Be careful the same as the caution in ‘1.2.1

Installing the main unit (532nm hand piece) when

connecting the SMA holder.

When connecting the scanner hand piece signal

connector, connect it as the arrow direction until it

clicked. If connecting it with the main unit tightly,

it may cause a failure.


Chap. 5 How to use the equipment

1. How to use for each mode

Install the equipment referring to ‘1.2 Installing the equipment’ of ‘Chap. 4 How to install the equipment.’ All the

operating modules and the display screen are appeared on the LCD monitor (A) at the front of the main unit, and it

is operated by touching the screen because it is a touch screen.

1.1 How to turn power on/off and use the main screen

1) Insert the power key, and rotate the key switch to turn power on.

2) If power is on, a popup window indicating ‘SYSTEM START’ is opened as follows, and after

about 2~3 seconds the main screen, which has five touch boxes, is appeared.

After 2~3 seconds

Fractional: Enter into the scanner mode to display the operating screen

required when using the scanner hand piece.

940 nm Normal: Enter into the 940 normal mode to display the operating

screen required when using the 940 normal hand piece.

532 nm Normal: Enter into the 532 normal mode to display the operating

screen required when using the 532 normal hand piece.

Information: Change the skin type.


Help

3) When touching a box of the desired mode, the screen is changed into a window of the

corresponding mode.

4) If the equipment will be off, rotate the key switch to turn power off on the current window

(main screen,) and pull it out.

Make sure that power is turned on after completing the equipment installation. If

power is turned on or trying to enter into each mode before completing the

equipment installation, error messages are appeared and the equipment cannot be

operated.

It is unable to simultaneously enter into two modes at a time. Enter into another

mode after finishing a mode procedure.


1.2 How to use 532 / 940 normal modes

1) When selecting the 532 or 940 normal box on the main screen, the normal screen, which a

box of each function is placed, is appeared.

2) Before setting the power, firstly, the spot size of laser irradiation must be adjusted by rotating

the hand piece’s knob. Adjusted spot size of laser irradiation is appeared on the Spot Size Box

at the left side of ② Power Adjust Section of the screen.

Spot Size: Box to indicate the spot size of laser irradiation

adjusted by the hand piece’s knob on the screen.

3) After completing the setup of spot size, set the power by touching the following menus one by

one in the ① Parameter Menu Box. When touching a menu to be set, the selected menu is

appeared on the UP / Down Box at the right side in the ② Power Adjust Section.

Power: Specifying energy intensity.

Density: Specifying energy quantity per unit area.

③ Power &

Other Menu

Section

② Power

Adjust

Section

① Parameter

Menu Box


Pulse Duration: Specifying energy radiation time per a cycle.

Repetition Rate: The number of energy radiating per a second (The number

of shot.)

Aiming: Specifying brightness of the pointing beam (laser aiming location

of lesion.)

4) The selected menus are appeared on the UP / Down Box as the following emoticons,

respectively. After checking the selected menu, touch the white triangle-shaped button to

adjust the power.

UP / Down Box: Box to adjust the power of the selected menu.

Menu Icon

5) When touching the STANDBY at the right upper side of ③ Power & Other Menu Section

after completing to set the power of all the menus, blue is changed into orange to become the

READY state as follows. Then, the foot switch is pressed to irradiate laser.

Stand By / Ready: Standby/ready for laser

irradiation.

6) If the current setup condition is desired to store, touch the number to be stored on the

STORAGE Box at the right lower side of ③ Power & Other Menu Section, and touch the

circle-shaped SAVE, then the current setup condition is stored into the corresponding number.

Later, if the stored data is desired to recall, touch the corresponding number and the circle-

shaped LOAD to input the stored setup values into the screen.

Storage: Box to store the current setting power.

Store up to 5.

7) After completing the surgical procedure, touch the BACK at the right topmost of the screen to

return to the main screen, and if the equipment is wanted to turn off, rotate the key switch on

the main screen to turn power off and pull the key out.


8)

Other indication boxes

Counter Reset: Box to indicate the number of irradiated laser shots.

When pressing the circle-shaped RESET, the count becomes 0.

/ Sound On / OFF: Whether or not to use sound effects when

operating menus.

Sound On / OFF is toggled whenever touching the box.

Before setting the power of menus, be sure to firstly adjust the spot size.

Adjustable setup values for menus become different depending on the spot size.

(Refer to ‘Chap. 6 Parameter values’)

Be sure to set the power under the STANDBY state, and to change into the

READY state after completing the setup.

Because laser is irradiated when pressing the foot switch in the READY state, be

sure to change into the READY and press the foot switch after aiming the hand

piece to treatment locations of the patient.

The foot switch must not be accessed by any person other than the equipment user

(doctor.)


1.3 532 / 940 Fractional screen

1) When selecting the fractional box on the main screen, the fractional screen, which boxes of

each function are placed, is appeared.

2) Set the power by touching the following menus in ① Parameter Menu Box one by one.

When touching a menu to be set, the selected menu is appeared on the UP / Down Box at the

right side of the screen. (Refer to the 2) in 1.1 532 / 940 Normal screen.)

Power: Specifying energy intensity.

Density: Specifying energy quantity per unit area.

Pulse Duration: Specifying energy radiation time per a cycle.

Repetition Rate: The number of energy radiated per a second (The number

of shots.)

① Parameter

Menu Box

③ Spot Size Adjusting Box

③ Other Indication Box


Distance: Interval between dots of radiated energy.

Scanning: Direction and style of radiated energy

Aiming: Specifying the brightness of pointing beam (laser aiming locations

of lesion.)

3) The selected menus are appeared on the UP / Down Box as the following emoticons,

respectively. After checking the selected menu, touch the white triangle-shaped button to

adjust the power.

UP / Down Box: Box to adjust the power of selected menu.

Menu Icon

4) After setting the menu, adjust the energy size to be radiated on ③ Spot Size Adjusting Box.

Adjust to the desired size and shape by touching the circle-shaped arrow and the white

triangle-shaped button in the box.

Bidirectional size adjusting button: When touching

this button and the white triangle-shaped button, size

is adjusted up/down or to both sides.

Fixed ratio size adjusting button: When touching

this button and the white triangle-shaped button, size

is adjusted up/down or to both sides as the same

ratio.

5) After setting the power of all menus, change the STANDBY / READY to press the foot

switch and irradiate laser. (Refer to 5) in 1.1 532/940nm normal screen.)

6) If the current setting condition is desired to store, store the setup values in the STORAGE.


(Refer to the 6) in 1.1 532 / 940 normal screen.)

7) After completing the surgical procedure, touch the BACK at the right topmost of the screen to

return to the main screen, and if the equipment is wanted to turn off, rotate the key switch on

the main screen to turn power off and pull the key out.

Other indication boxes

Pixel: Box to indicate the number of radiated laser’s dots

Coverage: Energy ration within radiated laser range

When adjusting laser setting values, be sure to adjust it after checking energy ratio

of the coverage. The ratio more than 100% may be outputted depending on the

laser radiation size and the interval between dots etc.

Be sure to set the power in the STANDBY state, and to change into the READY

after completing the setup.

Because laser is irradiated when pressing the foot switch in the READY state, be

sure to change into the READY and press the foot switch after aiming the hand

piece to treatment locations of the patient.

The foot switch must not be accessed by any person other than the equipment user

(doctor.)


2. How to use the hand piece (normal)

Since the one-touch adjusting knob is mounted, the spot size or focus, which is varied

depending on the lesion size, is not adjusted on the main unit, but it can be immediately

adjusted on the hand piece during the surgical procedure.

Spot Size: 0.7mm

1.2mm

2.0mm

2.8mm

When rotating the red line of hand piece’s knob to each focus location, it gets in focus with a snap.

The focus and spot size adjusted on the hand piece is sent to the main unit to display on the monitor.

Values of the density and the pulse duration are changed according to the spot size of hand piece sent to

the main unit. (Quantity of energy radiation is automatically adjusted depending on the energy density.)

Be sure to set the power of the main unit after adjusting the spot size and focus on

the hand piece.

Be sure to perform the procedure after checking the power of the main unit when

adjusting the spot size depending on the lesion. (Even though setting values of

energy are automatically adjusted within the safe range according to the spot size,

energy power can be readjusted according to the patient’s skin condition and

lesion condition.)



The followings are expressions and tables explaining the equipment setting range.

Set the power referring these tables.

1. Energy formula per unit area

1) J = W x S

2) Area of the spot size (㎠) = radius x radius x 3.14

3) J/㎠ = J ÷ ㎠

Ex) When assuming that W is 8, Duration is 10ms, spot size is 0.7mm,

J = 8W x = 0.01s (10ms) = 0.08J

spot size (0.7mm) area (㎠) = 0.035 x 0.035 x 3.14 = 0.003848㎠

J/㎠ = 0.08J / 0.003848㎠ = 20.7875J/㎠


2. Energy intensity for each spot size

1) 532nm

Watt (energy intensity): Min – 0.5W / Max – 8W (0.1 step)

Duration (energy radiation time per a cycle): Min – 10 / Max – 400 (1 step)

Spot 0.7 1.2 2 2.8

Area 0.00385 0.01131 0.03142 0.06158

Min/Max min max min max min max min max

J/㎠ 1.2 831.5 0.4 282.9 0.1 101.8 0.08 51.9

3. Specification sheet

532 green

(option)

532 green

Fractional

(option)

940 Diode

(option)

Wavelength 532 nm 532 nm 940 nm

Power (Max) 8.0 Watt 8.0 Watt 40.0 Watt

Density (Max) 831.5 J/㎠ 70.7 J/㎠ 4157.5 J/㎠

Aiming beam

532nm

MAX 35mW

532nm

MAX 35mW

650nm

MAX 5mW

Pulse Repetition Rate 0Hz ~ 15Hz 1Hz ~ 50Hz 0Hz ~ 15Hz

Laser Optically Pumped Semiconductor Laser Technology

Spot Size 2.8mm (Max) 1.2mm 2.8mm (Max)

Pulse duration 400ms 100ms 400ms

Electrical power 100 - 200VAC - 50/60Hz

Cooling Air Cooling

Display 10.4" Color TFT LCD Panel with CCFL Back Light (800*600)


Chap. 7 Description of error messages

The followings are warnings or notifying popup messages appeared during using or operating. When

displaying the following messages, immediately stop the surgical procedure, and readjust the equipment

after checking the message.

Screen displaying an error message

An error messages is appeared as the following screen,

the message is differently displayed in the box according

to the error. Refer to the table below for the error

information.

Error Error Information Solutions

INTERLOCK

ERROR

INTERLOCK ERROR

Please check

the interlock

ERROR CODE: E0401

Error message occurred when the remote interlock

of main unit’s rear side is disconnected. Reconnect

the remote interlock after checking the connected

state of it.

FOOT

SWITCH

ERROR

FOOT SWITCH ERROR

Please check

the foot switch

ERROR CODE: E0501

Error message occurred when the foot switch of

main unit’s rear side is disconnected. Reconnect

the foot switch after checking the connected state

of it.

SCANNER

ERROR

SCANNER ERROR

Please check

the Scanner

ERROR CODE: E1103

Message occurred when the scanner hand piece is

not connected or removed in the Factional mode.

Reconnect the scanner hand piece after checking

the connected state of it.

532 LASER

ERROR

532 LASER ERROR

Please check

the Cable

ERROR CODE: E0307

Message occurred when the 532nm hand piece is

not connected or removed. Reconnect the 532nm

hand piece after checking the connected state of it.

1450 LASER

ERROR

1450 LASER ERROR

Please check

the Laser

ERROR CODE: E0307

Message occurred when the 1450nm hand piece is

not connected or removed. Reconnect the 1450nm

hand piece after checking the connected state of it.


532 LD

OVER TEMP

ERROR

532 LD OVER TEMP ERROR

Please check

the Laser

ERROR CODE: E0305

Message appeared when the temperature inside the

532 laser exceeds the setting range, ask to the

agency.

532 LBO

OVER TEMP

ERROR

532 LBO OVER TEMP ERROR

Please check

the Laser

ERROR CODE: E0305



agency.

532 BRF

OVER TEMP

ERROR

532 BRF OVER TEMP ERROR

Please check

the Laser

ERROR CODE: E0305



agency.

940 OVER

TEMP

ERROR

940 OVER TEMP ERROR

Please check

the Laser

ERROR CODE: E0305



agency.

532 HEAT

SYNK OVER

TEMP

532 HEAT SYNK OVER TEMP

Please check

the Laser

ERROR CODE: E0305

Message appeared when the temperature of the

heat sink to cool the 532 laser exceeds the setting

range, ask to the agency.

940 HEAT

SYNK OVER

TEMP

940 HEAT SYNK OVER TEMP

Please check

the Laser

ERROR CODE: E0305


heat sink to cool the 940 laser exceeds the setting


IGBT HEAT

SYNK OVER

TEMP

IGBT HEAT SYNK OVER TEMP

Please check

the IGBT

ERROR CODE: E0702


heat sink to cool the IGBT exceeds the setting


532 HT

TEMP OPEN

ERROR

532 HT TEMP OPEN ERROR

Please check

the Laser

ERROR CODE: E1401

Message appeared when the temperature sensor of

the heat sink to cool the 532 laser is opened, ask to

the agency.


940 HT

TEMP

OPEN

ERROR

940 HT TEMP OPEN ERROR

Please check

the Laser

ERROR CODE: E1401


the heat sink to cool the 940 laser is opened, ask to

the agency.

IGBT HT

TEMP

OPEN

ERROR

IGBT HT TEMP OPEN ERROR

Please check

the Laser


the heat sink to cool the IGBT is opened, ask to the

agency.

ERROR CODE: E1401

LASER

MON

ERROR

LASER MON ERROR

Please check

the Laser

ERROR CODE: E0301

Message appeared when the power is radiated more

than the setting laser energy, ask to the agency.


Chapter 8 Specifications of Equipment

1. Specification of Equipment

1.1 Electrical Specification

1) Rated Power

Input Voltage and Consumptive Power:

210~240VAC±10%, 50/60Hz, 700VA

2) Protection Type and Degree against Electrical Shock:

Class 1 Device and B Type Device

3) Laser Hazardous Class by IEC60825-1(2001): Class 4

4) Laser Output

Used medium: diode-pumped, diode

Laser diode type: Disk laser, diode laser

Spec for each mode (wavelength): Refer to ‘3. Specification sheet in Chap. 6’

(5) Laser information according to IEC60825-1 (2001)

- Laser class: Irradiating beam – class 4 / Pointing beam – class 3B (532nm)

- Laser wavelength: Irradiating beam - 532nm/ Pointing beam - 532nm

- Laser power: Irradiating beam - 8W/ Pointing beam - 40mW, 40mW

- Laser medium: Irradiating beam - Diode Laser / Pointing beam - Diode Laser

1.2 Mechanical Specification

1) Dimension : 410mm x 390mm x350mm [WxDxH]

2) Handpiece (normal) : 150mm [H], 35π

3) Handpiece (fractiomal) : 110mm x 85mm x50mm [WxDxH]

4) Weight : 20kg


2. Items to Be Mentioned on Equipment

1) Product Name: Laser Surgery Unit (A37010.10)

Model Name: MULTIPLE IRIS

2) Name of Manufacturer: ILOODA CO., LTD.

Address: #801~805 Venture Valley, 958 Gosaek-Dong, Gwonseon-Gu, Suwon City,

Gyeonggi-Do, Korea

3) Manufacture Permission Number: No. 2461

Article Permission Number: No. 10-56

4) Using Purpose: Laser Surgical Unit using semiconductor diode laser as a medium.

Used for cutting, destruction, and removal of tissues etc.

5) Manufacture Number/Date of Manufacture: To be written when the product is manufactured.

6) Weight and Packing Unit

(1) Weight: 20 Kg

(2) Packing Unit: 1 Set

7) Performance and Using Method: Refer to the Manual

8) Cautions in Use: Refer to the Manual

9) Rated Power and Voltage

(1) Rated Electricity: 210~240VAC±10%

(2) Frequency: 50/60Hz

(3) Consumptive Power : 700 VA

(4) Protection Type and Degree against Electrical Shock: Class 1 Device and Type B Device

(5) Laser Hazardous Class by IEC60825-1(2001):

Class 4 (Aiming beam and radiation beam are the same as Class 4)


10) Others

- Safety Label

Warning label against laser output on main body and handpiece

Warning label against laser radiation on back side of main body

Label about stoppage of laser output in emergency on upper side of main body

11) Attachment of Labels: Back side of main body

12) This product is a medical apparatus.

2 / 43 ilooda co.,ltd - msc medical · 7 / 43 ilooda co.,ltd chap. 2 introduction to multiple iris...

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