COSMOXEL

CO2 M edical Laser

Operator’s Manual

Document No.: CUM-15-E

March 11, 2013 (rev.1)

5Fl., Joongil Eines Platz III, 519, Dunchon-daero, Jungwon-gu, Seongnam-si, Gyeonggi-do 462-807, Korea

Tel: +82 31 747 9900 http://www.choyangmed.com

CUM-15-E(Rev.1) CHOYANG MEDICAL INDUSTRY LTD. １

©2013, CO2 Medical Laser
Choyang Medical Industry Ltd.

All rights reserved. This publication is protected by copyright. Copying, disclosure to

others or the use of this publication is prohibited without the express written consent of
Choyang.

Choyang reserves the right to make changes in the specifications shown herein without
notice or obligation. Contact your Choyang representative or Choyang customer service
for more information.

CUM-15-E(Rev.1) CHOYANG MEDICAL INDUSTRY LTD. ２

 Contents

Introduction
1.1 Using this Manual 1
1.2 Safety 2
General

Burn Hazard

Reflection and Direct Eye Exposure Hazard

Safety Eyewear
Exposure and Fire Hazard

High Voltage Hazard

Using the Proper Power Receptacle and Plug

Water proof of foot switch

Grounding the Unit

Fuse Replacement

Compliance with International Standards

Warning and Identification

System Description
2.1 General 6
2.2 System Specification 8

Installation
3.1 General 9
3.2 Requirements 10
Space Requirements

Environmental Requirements

Equipments List

Line Power Considerations

Footswitch Connection

CUM-15-E(Rev.1) CHOYANG MEDICAL INDUSTRY LTD. ３

 Articulated Arm

Operation
4.1 General 11
4.2 Preparing the Unit for Operation 11
4.3 Control Panel 12
4.4 Turn-on Procedure 13
4.5 Change Handpiece to Scanner 13
4.6 System Modes of Operation 14
4.7 Preparing the Unit for Transportation/Storage 15

Maintenance/Troubleshooting
5.1 Introduction 16
Service Information

Routine Maintenance

Fuse Replacement

External Cleaning/Disinfection

Lens and Mirror Cleaning

5.2 Troubleshooting 19
Trouble Shooting Guide

Appendix
A.1 Laser Safety 22
A.2 Basics of Laser Technology 24
A.3 System Modes of Operation 26
A.4 Applications 31
A.5 The setting guide 32

CUM-15-E(Rev.1) CHOYANG MEDICAL INDUSTRY LTD. ４

 CHAPTER

1
Introduction

1.1 Using this Manual

This manual describes COSMOXEL, digital CO2 fractional laser. The manual describes the features of the laser,
how to setup and operate the laser, and maintenance and troubleshooting procedures to keep the laser in
good operating order.

Throughout the manual are notes, service notes, cautions, and warnings. These provide additional important
information. An example of each is illustrated below.

CUM-15-E(Rev.1) CHOYANG MEDICAL INDUSTRY LTD. ５

1.2 Safety

General
The COSMOXEL laser system is specially designed to minimize accidental exposure to hazardous radiation.
The areas of concern for safe CO2 laser operation are discussed in this chapter. The area of concern for
intended use of COSMOXEL is the dermatology surgery.

Burn Hazard
CO2 laser radiation is invisible to the human eye and can cause third degree burns, even when unfocussed.

Reflection and Direct Eye Exposure Hazard

The system output beam visible and invisible laser radiation that is hazardous to the eye. Never stare into
the CO2 laser beam or allow it to be reflected from any reflective surface – even rough metal can reflect the
CO2 laser beam. And never stare into the aiming beam directly. Although this beam is low powered, direct
exposure can be hazardous to eyes.

Safety Eyewear
All personnel in the vicinity of the laser unit must use safety eyewear, and must certain that the eyewears
provide adequate protection from the 10.6 micron wavelength radiation. This is generally provided by most
quality safety glass spectacles with side guards for protection from lateral exposure. The American Optical
spectacle-type safety glasses, or equivalent, provide ample protection. Safety eyewear is not required when
viewing through a microscope, colposcope or endoscope, as the glass lenses of these instruments provide
sufficient protection.

Patient Safety
For enhanced patient safety, perform the following safety procedures:
1. Surround the surgical area with wet towels.
2. Make sure that safety eyewear is available to the patient, if conscious.
3. For facial surgery, completely cover the patient’s eyes with moistened eye pads.

Exposure and Fire Hazard

Do not operate the unit in the presence of volatile substances (or flammable anesthetics) such as alcohol,
gasoline or solvents.

CUM-15-E(Rev.1) CHOYANG MEDICAL INDUSTRY LTD. ６

High Voltage Hazard
The COSMOXEL laser system generates high voltages within the main case. To avoid injury, do not attempt
to remove or disassemble any panels. Only Choyang Medical authorized technical person may service the
unit.

Using the Proper Power Receptacle and Plug

Use only the power receptacle and plug specified for your unit.
Use only a power receptacle and plug that are in good condition.
Use only a hospital grade plug and a correctly matched power receptacle.
To remove the power cord from the receptacle, hold it by the plug.
Never pull on the power cord to remove the plug from the receptacle.

Water proof of foot switch

IPX5 Class Foot switch is perfectly protected against any possible vibration. Water Proof is secured in any
direction under the condition of 3m distance, 12.5L/min, 30kpa, in 3 min. Do not use in any excess
conditions.

Grounding the Unit

The unit is grounded through the grounding conductor in the power cord. Good grounding is essential for
safe operation. To ensure grounding reliability, always plug the power cord into a properly wired hospital
grade power receptacle. Additional grounding can be provided by using the external ground connection point.
(See 3.2)

Fuse Replacement
The user may replace a line fuse that is located beside the power cord connection on the auxiliary panel. To
avoid fire hazard, use only the fuse specified for your unit. Replacement fuse must be identical in type,
voltage rating and current rating to the original fuse.
(Warning: Before removing a fuse, turn off the key switch and remove the power cord from the ac outlet.)

Compliance with International Standards

The COSMOXEL laser system complies with: U.S Federal Performance Standards 21 CFR 1040.10 and 21 CFR
1040.11 for Class IV laser products and European Directive 93/42/EEC Concerning Electromagnetic
Compatibility.
The COSMOXEL laser system is designed to comply with the IEC601-1 Standard for safe Use of Electro-
medical Equipment, IEC601-2-22 standard [medical electrical equipment Part2: particular requirements for
the safety of diagnostic and therapheutic laser equipment], the IEC 825-1 Safety of Laser Products –
Equipment Classification Requirement, and the User’s Guide for Class IV Laser Products.

CUM-15-E(Rev.1) CHOYANG MEDICAL INDUSTRY LTD. ７

In compliance with these standards, the COSMOXEL laser system incorporates a CO2 laser beam shutter, a
power display, a master key switch and proper labeling.
The system also incorporates an input power transformer that ensures a leakage current of less than 150 μA.
In accordance with these regulations, a recommended routine inspection and maintenance schedule is
provided in the maintenance chapter of this manual.

Warning and Identification

The important labels affixed to the unit. These include:

1. Laser emission danger label – warning against possible exposure to laser radiation and specifying
the types of laser present

2. Non-interlocked warning label-warning against.

A. Risk of explosion if used in the presence of volatile substances.
B. Possible electrical shock when cover is removed.
C. Possible radiation exposure.

3. Attention label – instructing the user to use only the tab to lift the articulated arm.

DO NOT DISASSEMBLE
OR REMOVE FROM
SYSTEM

4. Laser aperture warning label – indicating laser beam exit location.

CUM-15-E(Rev.1) CHOYANG MEDICAL INDUSTRY LTD. ８

 LASER APERTURE
AT PROBE TIP

5. Electric shock warning label – warning user to properly ground the unit, and against opening the
unit’s cover.

6. Identification label – noting unit model number, serial number, electrical requirements, date of
manufacture and address.

CUM-15-E(Rev.1) CHOYANG MEDICAL INDUSTRY LTD. ９

 CHAPTER

2
System Description

2.1 General

The following is a description of the COSMOXEL laser systems controls, indicators and connection points
according to location.

①ARTICULATED ARM
1. Articulated arm : Deliver laser beam from
device.

HANDPIECE② 2. Handpiece : Placed at the end of articulated

arm.

③CONTROL DISPLAY
3. Control display with touch screen :
Controller with display for laser output, time
EMERGENCY SWITCH④ and mode.
KEY SWITCH⑤

4. Emergency switch : Stop operation in case

of emergency.

5. Key switch : ON / OFF Power

6. Wheel: Help for moving the device.

⑥WHEEL

CUM-15-E(Rev.1) CHOYANG MEDICAL INDUSTRY LTD. １０

 ①

④ ③ ②

Refer to figure as below for items 1 to 4.

1. Line Connection – connection point for the AC power cord

2. Line Fuses – installation point for line fuse.
3. Door Interlock - connection point for an external remote interlock switch.
4. Foot S/W Connection – Connection point for footswitch cable.

CUM-15-E(Rev.1) CHOYANG MEDICAL INDUSTRY LTD. １１

2.2 System Specification

SYSTEM SPECIFICATION

LASER TYPE SEALED OFF CO2 LASER TUBE

WAVELENGTH 10,600㎚

LASER MODE TEM00

7 JOINTS ARTICULATED MIRROR ARM

DELIVERY
WITH FRACTIONAL HANDPIECE

COLLING WATER COOLING WITH SEALED CLOSED CIRCUIT

DISPLAY GRAPHIC LCD DISPLAY

OPERATION MODE CONTINUOUS, PULSE, SCAN MODE

EMISSION MODE Continuous, Repeat, Single

POWER (Max) 25 W

BEAM AREA 1*1 ~ 25*25 (㎜)

SPOT SIZE 200㎛

PITCH 200㎛ ~ 2.0㎜

ON TIME: 0.01~10 sec

OPERATION
OFF TIME: 0.1~5 sec

OPERATING TIME Power ON: max 5 min, power OFF : 1min

PULSE WIDTH 10~5000㎲

ELECTRICAL REQUIREMENT 220~240VAC, 50/60Hz 500VA

DEMENSION 400 * 420 * 1120 ( W * D * H )

WEIGHT 51 ㎏

CUM-15-E(Rev.1) CHOYANG MEDICAL INDUSTRY LTD. １２

 CHAPTER

3
Installation

3.1 General

The COSMOXEL laser system has passed full quality assurance testing before shipment. Thus, the unit
should be operational upon delivery. The unit should be unpacked, installed and tested only by an authorized
Choyang Medical representative. Do not attempt to unpack or assemble the unit.

3.2 Requirements

Space Requirements
The working area for the COSMOXEL laser systems
should be prepared according to the dimensions
shown in figure on the right. The length of the
unit’s power cord is 2.5m. In order to guarantee
adequate ventilation, position the unit away from
the wall or from any other obstructions to air flow. 1120

Environmental requirements
Air quality
The COSMOXEL should operate in a non-corrosive
atmosphere. Corrosive materials such as acids can
damage electrical wiring, electronic components
and the surfaces of optical components.
Temperature
400 420
To ensure that the COSMOXEL can perform
optimally, it is recommended to maintain room temperature between 15°C and 30°C and relative humidity
of less than 80%. It is recommended to install air conditioning.

CUM-15-E(Rev.1) CHOYANG MEDICAL INDUSTRY LTD. １３

Environment conditions
Operation temperatures 15°C ~ 30°C

Storage temperatures 0°C ~ 55°C

Relative humidity - operating up to 80%

Relative humidity - storage up to 90%

Equipment List
The COSMOXEL laser systems includes the following:

1. COSMOXEL laser unit

2. Footswitch
3. Power cord
4. Set of master keys
5. 7-joint articulate arm
6. Fractional handpiece set
7. Operator’s manual

Line Power Considerations

The unit is delivered factory-set for the proper ac line voltage rating of the country to which it is shipped.
The ac line voltage appears on the label affixed to the rear panel.
The unit is equipped with a power cord – one end for connection at the rear panel of the unit, the other end
with a 2-pin plug for connection to a single-phase ac receptacle, suited to the labeled power rating.

Footswitch Connection
The footswitch is in the blue box. To connect the footswitch to the unit, position it on the floor and plug its
cable into the FOOT SWITCH connection point on the rear panel. A polarizer on the socket prevents incorrect
connection of the cable.

Articulate Arm
The articulate arm is in the yellow box. To assemble the articulate arm to the unit, position it in socket on
the unit and screw the socket nut of articulate arm. For good assembling, look at the red aiming beam. If
the red aiming beam is seemed to be focused, then its alignment is to be done.

CUM-15-E(Rev.1) CHOYANG MEDICAL INDUSTRY LTD. １４

 CHAPTER

4
Operation

4.1 General

This chapter contains detailed operating instructions for the COSMOXEL laser unit. For easy reference, a
checklist-type summary of procedures for the entire operation is also included.

4.2 Preparing the Unit for Operation

1. Remove the Covering from the unit.

2. Connect the articulated arm to the socket on the upper cover.
3. Connect the fractional handpiece to the end of the articulated arm.
4. Plug the footswitch cable into the FOOT SWITCH connection point on the rear panel.
5. Plug the power cord into the AC220V connection point, and the other end into a suitable ac outlet.
6. Connect the silicone tube to the air flow connection point, and the other end to handpiece.

CUM-15-E(Rev.1) CHOYANG MEDICAL INDUSTRY LTD. １５

4.3 Control Display

1. Main display
Set mode among Continuous, Pulse and Scanning mode.

2. MODE
Set sub-mode Continuous, repeat, single mode in CW and
PULSE MODE.

3. POWER
Set power from 0 up to 25 Watt

4. ON TIME
Set on time from 0.01 to 10 sec

5. OFF TIME
Set off time from 0.1 to 5sec

6. MULTI-APPLICATION
Set shot number from 0 up to 10

7. PITCH
Set pitch

8. BACK
Retune to initial display.

9. SOUND
Function of turning on or off sounds

10. M1
Save parameters onto function memory(5 settings)

11. STANDBY/ READY

Set ready or stand-by

CUM-15-E(Rev.1) CHOYANG MEDICAL INDUSTRY LTD. １６

4.4 Turn-on procedure

1. Turn Main Key Switch in the front of device.

2. Control the bright of guide beam by “Aiming beam” knob placed below touch screen.
3. Wait until the initial display appear on the screen.
4. Select laser modes for CW / PULSE / SCANNING.
5. Select the emission mode for Single, Repeat, Continuous
6. Set other parameters included in mode(power, time, pulse duration etc.) by UP( ) & DOWN( )
key.
7. Press “Ready” button on the display.
8. Press “Foot Switch(pedal)” to operate the laser emission after facing a handpiece or scanner of
articulated arm to a black burn paper. Make sure Aiming beam is alignment with laser beam
visually.
9. Press “Foot Switch” (pedal) to operate the laser emission after facing a handpiece or scanner of
articulated arm to a patient.
10. In emergency , push “ Emergency (stop) for the immediate power down.
11. After usage, press “Stand-by” button on the display.
12. Turn off “Main Key Switch”.

4.5 Chang Handpiece to Scanner

1. Separate “Handpiece” from “ARM” by turning connector counterclockwise

2. Connect “Scanner” to the end of “Arm”
3. Connect cable and air blowing tube with “Scanner”
4. Join “Holder” in order to tie with Scanner and cable.
5. Plug in “cable” to connection placed on rear panel.

CUM-15-E(Rev.1) CHOYANG MEDICAL INDUSTRY LTD. １７

4.6 System Modes of Operation

The “COSMOXEL” laser systems modes of operation are based on two distinct types of settings: the
laser operation mode and the emission mode settings. The laser operation modes control the power
pattern and using purpose, while the emission modes control the duration pattern of the laser beam
delivered to tissue.
The system offers three operation modes and three tissue exposure modes as follows:

Laser Operation Mode Emission Mode

1. CONTINUOUS WAVE (C.W) 1. Continuous
2. PULSE 2. Repeat
3. SCANNING 3. Single

Each laser operation mode is available in the two or three emission modes, thus yielding the following
eight system modes of operation, for a wide range of clinical applications:

1. C.W_Continuous 4. PULSE_Continuous
2. C.W_Repeat 5. PULSE_Repeat 7. SCANNING_Repeat
3. C.W_Single 6. PULSE_Single 8. SCANNING_Single

<Emission Mode>
• SNG (single) : Stopped after emitting once in the set time.
• RPT(repeat) : Emitted in the fixed interval consecutively in the set time.
• CON(continuous) : Emit continuously during pushing foot switch (pedal)

<Memory Function>
To store the power mode in use now…
1. Press M X key repeatedly and choose the one memory from M 1 to M 5.
2. Press selected “M x ” key for more than 2 seconds. Then, “Saved…” message appears on display.

<Call up memory>
To call up saved memory…
1. Press M X key repeatedly and set the one memory needed to use among M1~M5.

CUM-15-E(Rev.1) CHOYANG MEDICAL INDUSTRY LTD. １８

4.7 Preparing the Unit for Transportation/Storage

When the unit is to be transported to another location or stored, the following must be performed

1. Disconnect any laser accessories.

2. Disconnect the footswitch and stow the footswitch cable in the footswitch housing
3. Disconnect and stow the power cord in the footswitch housing.
4. Stow the footswitch in its compartment.
5. Arrange the silicone air tube so that it extends along the inside of the three sections of the
articulated arm.
6. Replace the top cover of the unit
7. Place the User’s Manual

CUM-15-E(Rev.1) CHOYANG MEDICAL INDUSTRY LTD. １９

CHAPTER

5
Maintenance/Troubleshooting

5.1 Introduction

This chapter contains the COSMOXEL laser systems routine inspection and maintenance instructions. Only
those procedures designated herein may be carried out by clinic/hospital staff. All other procedures
designated herein may be performed only by CHO YANG MEDICAL-authorized technical personnel.

Service Information
The COSMOXEL Laser system generates high voltages within the main cabinet. Therefore, the interior of the
unit should be checked by CHOYANG MEDICAL authorized technical personnel only.
All correspondence with your CHOYANG representative, regarding the unit, should include the model and
serial numbers appearing on the identification label.

Routine Maintenance
The unit should be periodically inspected and serviced to maintain it in optimum condition. A recommended
routine inspection and maintenance schedule is given in.

CUM-15-E(Rev.1) CHOYANG MEDICAL INDUSTRY LTD. ２０

Table 6-1 Fault Status – Troubleshooting Guide
Fault Status Probable Cause Action

HEAD TEMPERATURE Cooling system malfunction Press OFF/RST and wait a few minutes. Reinitiate system operation. If problem

persists, refer to Cho Yang MEDICAL – authorized technical personnel

H.V.P.S. FAILURE High voltage circuit problem Press OFF/RST and wait a few minutes. Reinitiate system operation. If problem

persists, refer to Cho Yang MEDICAL – authorized technical personnel

CO2 SHUTTER FAILURE - SHUTTER CO2 shutter problem Press OFF/RST and wait a few minutes. Reinitiate system operation. If problem

IS OPENED / CLOSED persists, refer to Cho Yang MEDICAL – authorized technical personnel

LOW COOLANT FLOW Coolant flow is below critical level Press OFF/RST and wait a few minutes. Reinitiate system operation. If problem

persists, refer to Cho Yang MEDICAL – authorized technical personnel

KEYBOARD FAILURE One or more keys are pressed upon key switch Press OFF/RST and wait a few minutes. Reinitiate system operation. If problem

turn-on persists, refer to Cho Yang MEDICAL – authorized technical personnel

POWER FAILURE Laser ignition circuit problem, or power detection Reset power. If problem persists, press OFF/RST and reinitiate system operation.

RESET POWER problem. If problem still persists, refer to Cho Yang MEDICAL – authorized technical

personnel.

RELEASE FOOTSWITCH Footswitch is depressed during system check or Release footswitch. Press OFF/RST and reinitiate system operation

when the system enters “ready” state.

OPEN LASER DIODE Laser diode beam intensity control is set to OFF Turn LASER DIODE beam intensity control to FULL or one of the medium

position upon key switch turn-on. positions

Table 6-2 Undisplayed System M alfunctions- Troubleshooting Guide

CUM-15-E(Rev.1) CHOYANG MEDICAL INDUSTRY LTD. I

 Fault Status Probable Cause Action

Power-off when key switch is turned on, 1.No AC power from local outlet, or power cord not properly 1.Ensure that ac power is available and that the power cord is

and unit is inoperable connected properly plugged into ac outlet and unit

2.Blown fuse on rear panel 2.Replace fuses

Power-on when key switch is turned on, Electronic malfunction. Refer problem to Cho Yang MEDICAL authorized technical

but unit is inoperable personnel.

Laser Diode aiming beam not available 1.Laser Diode beam intensity control is turned to OFF. Turn Laser Diode beam intensity control to FULL or to one of the

2.Laser Diode system problem medium positions

Very poor Laser Diode aiming beam is Laser Diode misaligned, articulated arm misaligned, or one Refer problem to Cho Yang MEDICAL authorized technical

present at handpiece tip or more mirrors are dusty or damaged personnel.

Laser beam emission does not occur when 1.Footswitch cable is improperly connected. Connect footswitch cable properly

footswitch is pressed 2.Unit is not in an operating mod Select one of the operating modes

3.electronic malfunction

No air flow when system is in READY state 1.Air tube is not connected at one of its connection points. 1.Connect the tube

2.Air compressor problem. 2.Refer problem to Cho Yang MEDICAL authorized technical

personnel

Mode, power setting or time setting can Blown display Refer problem to Cho Yang MEDICAL authorized technical

be selected, but its indicator does not personnel.

selected .

Mode, power setting or time setting Electronic malfunction Refer problem to Cho Yang MEDICAL authorized technical

cannot be selected personnel.

CUM-15-E(Rev.1) CHOYANG MEDICAL INDUSTRY LTD. II

 APPENDIX

A
Clinical guide

A.1 Laser Safety

1. Precautions
For more than 35 years, lasers have been used in medical applications. Given the large number of
successful treatments carried out with a laser, the number of incidents is disproportionately low.
Regardless of this, one should never underestimate the attention required for working with laser devices.
Negligent handling of laser radiation may cause serious injuries to the user and the patient.
The radiation emitted by a laser device is very intense. It may create hazards even at some distance
from the physical laser outlet opening. Incorrect use of laser radiation may result in major eye injuries
or burns to body tissue.
In the event of non-compliance with the instructions in this Manual, the laser may become a source of
potential danger for the doctor, patient or third party. Therefore, this manual describes how to operate
the laser as a medical device.
The decision on whether this laser is suited for a given medical application and which treatment method
should be selected for this application is the responsibility of the attending physician alone. Under no
circumstances should a laser treatment be performed when there is the slightest doubt about the
appropriate operating conditions of this device.

The use of control elements or the performance of adjustment or treatment

procedures in any other way than described in this Application Manual may release
dangerous laser radiation. Under no circumstances should the protective shielding
be removed!

The wheeled cabinet unit of the laser may not be opened by anyone other that
expert personnel of Choyang medical. Attempted servicing of this device with the
help of persons not authoried by Choyang medical may have lethal consequences
and will immediately void any warranty.

CUM-15-E(Rev.1) CHOYANG MEDICAL INDUSTRY LTD. I

 2. Important Considerations before First Treatment

The purpose of this Manual is to provide special application advice for the operation of this laser. It

should be understood that such advice can in no way be considered to replace intensive studies of

technical literature, personal experience obtained under the supervision of expert personnel and critical

considerations in every single case.

On the other hand, it is necessary to assist "Newcomers" and those who do not work with the system

regularly by supportive guidance.

For this reason, we recommend the study of current literature and contact with privately practicing

physicians who work with this kind of laser equipment, in order to familiarize oneself with the methods

that use a laser, before proceeding with the treatment of patients.

We will gladly assist you in establishing contacts with other users.

Check yourself if you have really understood the way the laser and the body tissue

interact, the relationships between the individual application parameters and the

applied technique, and the principles of laser safety.

If you have the slightest doubt, consult one or more colleagues with practical

experience and/or application engineers of Choyang medical, before you begin

laser treatment.

CUM-15-E(Rev.1) CHOYANG MEDICAL INDUSTRY LTD. II

A.2 Basics of Laser Technology

1. The Laser

Since MAIMAN invented the laser in 1960, it has established itself in all branches of science and

technology. Today, modern medicine cannot be imagined without lasers. (First dermatological

application by Goldmann in 1963).

Laser is the acronym for "Light Amplification by Stimulated Emission of Radiation".

What is typical of a laser? From a practical point of view, the laser is a light source emitting a narrow,

bundled beam. This beam is of a specific wavelength with its uniform waves propagating almost parallel

(collimated), in phase (coherent) and with little divergence.

Lasers are available in the wavelength regions from ultraviolet to infrared; laser powers range from a

few fractions of a milliwatt for medical applications to the kilowatt range for high-power lasers used in

industry.

If laser excitation is continuous, the laser is referred to as continuous-wave laser (cw-mode, for

instance, argon lasers). If the laser is excited by single pulses, the laser is called a pulsed laser (e.g.

ruby laser). If the excitation energy is accumulated and then suddenly released, the laser is referred to

as a q-switched laser (such as q-switched ruby laser).

2. Physical Background

Inside the laser, energy is pumped into an "active medium". This process is followed by forcing the

medium to release the stored energy in the form of light. In the so-called resonator, this light is then

bundled into a beam by means of mirrors.

The medium may be a gas (e.g. argon laser), a liquid (e.g. dye laser), a solid (e.g. ruby

rod) or a laser diode.

Generally, a light wave is generated when an atom "drops" from the "excited" state, where it has a high

energy level, to a lower-level state. The difference in energy between the two levels then corresponds

CUM-15-E(Rev.1) CHOYANG MEDICAL INDUSTRY LTD. III

 to the energy of the emitted wave.

The generation of laser radiation requires a state in which there are more excited atoms in the active

medium than atoms of a lower energy level. This kind of energy distribution is referred to as “inversion

".

In a laser, emission is triggered artificially by letting a light wave of identical energy hit an atom. This is

sufficient to stimulate the atom to emit its own wave of the same frequency.

For this reason, this process is called "stimulated emission".

The parallel bundled laser beam is generated by the resonator. In its simplest form, the resonator

consists of two parallel mirrors with the laser medium in between. When many light waves are

generated in the medium by emission, the mirrors will always reflect those waves back into the medium

that are incident at right angles. The reflected waves will again hit excited atoms while passing once

more through the medium thus generating more stimulated emission.

This process is continuing avalanche-like with the light beam becoming ever stronger. On one end of

the resonator, the mirror used is a partially transmitting mirror serving to output the usable laser beam.

The way of pumping energy into the laser or “charging the laser up” depends on the active medium

used. The major pumping techniques include the excitation by high-intensity light, which is also referred

to as "optical pumping" (e.g. ruby laser), the excitation by an electrical gas discharge (e.g. argon laser)

and the direct electrical pumping (diode laser).

3. Laser Safety

If applied improperly, laser light may cause damage.

The greatest potential hazard exists for the human eye as even very low powers may cause irreversible

damage to the retina due the focusing effect of the eye lens.

The nature of injury largely depends on the wavelength of the laser light.

Official regulations oblige the owner/operator of laser devices to take some precautions for their use. In

addition, users of medical lasers must meet the requirements laid down in the Medical Device Directive.

These regulations, among others, prescribe the following precautions for medical applications:

CUM-15-E(Rev.1) CHOYANG MEDICAL INDUSTRY LTD. IV

 * Mark the laser area (i.e. the room where laser radiation is emitted) and the laser device by laser warning

labels.

* Avoid reflecting surfaces in the operating room.

* Keep flammable substances away from the laser area or taking precautions to prevent that such

substances catch fire.

* Check devices, optical fibers, and beam delivery systems for visible defects.

* Observe user’s manual and application manual provided by the manufacturer; checking the necessary

safety devices for proper function before beginning laser operation.

* Power ON condition must be clearly visible on laser device and at the entrance to the laser area (warning

lamp).

* Users, patients, present personnel must wear appropriate laser safety goggles. Prior to using protective

eyewear, make sure it is in perfect condition.

* Just before switching the laser on, warn all persons present in the laser area that the laser is about to be

armed. Take necessary precautions to prevent the development and spreading of flammable gases and

vapors (risk of explosion) in the laser area.

* Provide for efficient evacuation of generated vapor (vaporization).

* Protect handpieces (particularly their optical end faces) from contamination.

* Use only those agents and methods for cleaning and disinfection approved by the manufacturer.

* Perform annual briefings of personnel on safety issues.

* Secure the laser device against inadvertent positional changes.

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A.3 System Modes of Operation

Note. The TEMoo mode structure (bell-shaped power distribution) is preserved in all modes of operation

1. Basic Concepts and Definitions

a. Frequency (f) – number of pulses per second.

b. Period or cycle time (T) – the time interval between the onset of two consecutive pulses. (T = 1/f;

T is inversely proportional to f.)

c. ON Time and OFF time – the time duration during which the laser is operative within the cycle

time(T) is called the ON time, whereas the time duration during which the laser is inoperative

within the cycle time(T) is called the OFF time. Thus,

Cycle time(T) = ON time + OFF time

d. Duty cycle(%) – the ratio between the ON time and the total cycle time(t), given as percentage:

Duty cycle(%) = ON time × 100/T

e. Peak power(Ppeak) – the maximum power delivered by the laser beam during emission.

f. Average power (Pav) – the time averaged power.

g. Pulse width(w) – the pulse duration at half peak power level.

Note – In this section, “ON time”, “OFF time”, and “duty cycle” refer only to the laser operation mode, and

not to the tissue exposure mode.

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 The peak power and average power are relation in the following manner:

a. For a square wave periodic function(such as in the CONTINUOUS WAVE REPEAT mode):

Pav = Ppeak × duty cycle/100

Thus, to obtain a variation in average power at a constant peak power, the duty cycle is adjusted

accordingly.

b. For a general periodic function(such as in the PULSE laser operation

mode), a good approximation of this equation of these parameters.

Pav = Ppeak × w × f

Thus, the average power can be controlled either by varying the peak power, the pulse width, the

frequency or any combination of these parameters.

In the PULSE laser operation mode, the Cosmopulse Plus provides the highest possible peak power to

obtain the requested average power.

2. Laser Operation Modes

The laser operation modes are CONTINUOUS WAVE(CW), PULSE. In the CW laser operation mode,
CUM-15-E(Rev.1) CHOYANG MEDICAL INDUSTRY LTD. VII
 the laser beam is emitted in continuous wave, whereas in the PULSE laser operation mode the laser

beam is emitted as a train of very narrow pulses.

In the CW laser operation mode, a continuous wave laser beam is emitted in the power range of 1 –

30W.

In the PULSE laser operation mode, the laser beam is emitted in a train of very narrow high-peak-

power pulses. The PULSE frequency and the ON time are adjusted by the microprocessor to obtain the

desired average power by maintaining either the ON time or the frequency constant. The power display

shows the PULSE average power, which ranges between 0.1 – 9.9W.

Tissue incision capability is generally enhanced with higher peak power of the laser beam. Thermal

damage to surrounding tissue is usually reduced with shorter laser activation durations, whereby the

adjacent healthy tissue has more time to cool between pulses.

The PULSE laser operation mode enable these tissue effects to be achieved through their constsnt high

peak power level and variation of the duty cycle for control of average power.

Figure A-2 illustrates the different power versus time patterns generated for each of the laser operation

modes. Note that although the average power can be identical in all three laser operation modes, the

peak power, ON time and OFF time differ. The treated tissue reflects these differences in terms of

incision/ablation effects, and of thermal condition to adjacent tissue.

Note – In Figure A-2, “ON time”and “OFF time” refer only to the laser operation mode

CUM-15-E(Rev.1) CHOYANG MEDICAL INDUSTRY LTD. VIII

 3. Tissue Exposure Modes

The tissue exposure modes control the duration pattern of the laser beam delivered to tissue. The three

tissue exposure modes are CONTINUOUS, SINGLE PULSE and REPEAT PULSE. The power versus time

pattern of each tissue exposure mode in the three laser operation modes is illustrated in Figures A-3

through A-5.

In the CONTINUOUS tissue exposure mode, the laser beam is emitted for as long as the footswitch is

pressed.

In the SINGLE PULSE tissue exposure mode, the laser beam is emitted as a single pulse(for the C.W

laser operation mode) or as a single burst(for the PULSE laser operation mode), for a preset

duration(ON time), or until the footswitch is released, whichever comes first. For C.W laser operation

mode, the ON time range is 0.01 – 1.0 sec

In the REPEAT PULSE tissue exposure mode, the laser beam is delivered intermittently as a series of

bursts for a preset duration, determined by the ON time and OFF time values, for as long as the

footswitch is pressed. The selected OFF time(emission duration) determines the interval between bursts,

while the selected ON time determines the number of burst.

CUM-15-E(Rev.1) CHOYANG MEDICAL INDUSTRY LTD. IX

Note

In Figure A-3 through A-5, “ON time” and “OFF time” refer only to the tissue exposure mode.

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CUM-15-E(Rev.1) CHOYANG MEDICAL INDUSTRY LTD. XI
A.4 Applications

1. used for removal of benign skin lesions i.e. moles, keratoses, biopsy, hemangioma, nevus, basil and

squamous cell carcinoma, rhinophyma reduction and to remove warts.

2. used as a "laser scalpel" in patients or body areas prone to bleeding.

3. used in "No-Touch" removal of tumors, especially of the brain and spinal cord.

4. used for shaving, dermabrading and resurfacing scars, rhinophyma and ablation of skin irregularities.

5. used for cosmetic laser resurfacing for wrinkles.

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A.5 The setting guide
1) CONTINUOUS(C.W) MODE & PULSE MDOE
Indication Power(W) Mode type On time Off time
Spot 1~2 PULSE Repeat 01~05 01~03
0.5~1 PULSE Continuous × ×
lentigo 3~5 PULSE Repeat 01~05 01~03
10~15 C.W Repeat 01~05 01~03
wart, corn 3~5 PULSE Repeat 01~05 01~03
syringoma 5~7 C.W Repeat 01~05 01~03
Condyloma 3~5 PULSE Repeat 01~05 01~03
10~15 C.W Continuous × ×
Allergic rhinitis 7 C.W Continuous × ×
Snore 15 C.W Continuous × ×

Phimosiectomy 5~7 C.W Continuous × ×

surgery 7 C.W Continuous × ×

2) SCANNING MODE
Interval
Indication Sex Power(w) Duration(㎲) Multiplication Pitch(㎜)
(week)
Medium skin MAN 1~5 420 1 1.0 3~4
resurfacing WOMAN 1~5 300 1 1.0 3~4
Large pore MAN 1~5 600 1 1.0 3~4
WOMAN 1~5 480 1 1.0 3~4
Wrinkle MAN 1~5 600 1 1.0 3~4
WOMAN 1~5 480 1 1.0 3~4
Skin resurfacing MAN 1~5 720 1 1.0 5~8
WOMAN 1~5 600 1 1.0 5~8
Acne scar MAN 1~5 600 1 0.7 3~4
WOMAN 1~5 480 1 0.7 3~4
Burn scar MAN 1~5 600 2 1.3 5~8
WOMAN 1~5 480 2 1.3 5~8
Traumatic scar MAN 1~5 540 2 1.2 5~8
WOMAN 1~5 420 2 1.2 5~8

Remark : This is only a reference guide and it must be applied to the patient by the decision of surgeon or
condition of lesions.

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