WONtech WON COSJET ATR S User manual

WON COSJETATR S
User Manual
WT-UM-08, v4.4
Issue date: April 14, 2015

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Copyright
Knowledge of this User Manual is necessary for system operation. You are therefore requested
to familiarize yourself with its contents and follow all notes or references regarding the safe
handling of the system.
The specifications are subject to change; the manual is not covered by an update service.
© Unless expressly authorized, forwarding and duplication of this document, and the
utilization and communication of its contents are not permitted. Violations will entail an
obligation to pay compensation.
All rights reserved in the event of a patent grant or a utility model registration.
EC Representative;
DONGBANG AcuPrime
Ⓡ
1 The Forrest Units, Hennock Road East Exeter
EX2 8RU, UK
TEL: [phone] FAX: [phone]
Manufacturer;
WON TECH Co., Ltd.
64 Techno 8-ro, Yuseong-gu, Daejeon, Korea
TEL: [phone] FAX: [phone]

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Table of contents
★SAFETY NOTES................................................................................................................................5
1. INTRODUCTION ..............................................................................................................................7
1.1 Intended Use .................................................................................................................................7
1.1.1 Description.............................................................................................................................7
1.1.2 Equipment application specification......................................................................................7
1.2 Applications..................................................................................................................................8
1.2.1 Side effect ..............................................................................................................................8
1.2.2 Contraindication.....................................................................................................................9
1.3 System Description.......................................................................................................................9
1.3.1 Laser System..........................................................................................................................9
1.3.2 Classifications........................................................................................................................9
1.3.3 Beam Delivery System.........................................................................................................10
1.4 Specifications and Requirements................................................................................................10
1.4.1 Technical Specifications......................................................................................................10
1.4.2 Electrical Specifications.......................................................................................................11
1.4.4 Environmental Requirements...............................................................................................11
1.4.4. Indication, Safety and Reference Symbols .........................................................................12
2. SAFETY ...........................................................................................................................................14
2.1 General Safety Rules...................................................................................................................14
2.2 Laser & Optical Hazards.............................................................................................................14
2.3 Laser-Induced Risk of Fire .........................................................................................................16
2.4 Electrical and Mechanical Hazards.............................................................................................17
3. GETTING STARTED......................................................................................................................18
3.1 Scope of Delivery .......................................................................................................................18
3.2 Systems Features.........................................................................................................................21
3.3 Articulated Arm..........................................................................................................................23
3.4 Handpiece ...................................................................................................................................25
3.5 Explanation of Term...................................................................................................................26
3.6 Manu Description........................................................................................................................27
4. INSTALLATION .............................................................................................................................28
5. HOW TO USE..................................................................................................................................30
5.1 Start-up........................................................................................................................................36
6. MAINTENANCE .............................................................................................................................41

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6.1 General Information....................................................................................................................41
6.2 Attention .....................................................................................................................................41
6.2.1 General Attention.................................................................................................................41
6.2.2 Individual Attention.............................................................................................................41
6.3 Cleaning Procedure.....................................................................................................................42
6.4 Check Points ...............................................................................................................................42
6.5 Technical Customer Service .......................................................................................................43
6.6 Notice after Treatment................................................................................................................43
7. LABELING AND PACKAGING ....................................................................................................44
7.1 Labeling of WON COSJET ATR S............................................................................................44
7.2 Laser Operation Danger Labels ..................................................................................................46
7.3 Packaging Label..........................................................................................................................47
7.4 Environment Requirements: .......................................................................................................49
8. DISPOSAL .......................................................................................................................................50
9. CONSUMABLES.............................................................................................................................51
APPENDIX 1........................................................................................................................................53

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★SAFETY NOTES
CAUTION
Lift the device up using handles on the rear and front case of the device to pass over
20mm threshold. Check dangerous obstructions such as pens, medical instruments and
etc. to prevent the device falling down.
CAUTION
Before starting up the laser system for any reason, the operator must ensure that all
personnel in the area are familiar with the safety concerns outlined in Section 2, and
that they are equipped with the correct safety goggles.
CAUTION
Use of controls or adjustments or performance of procedures other than those
specified herein may result in hazardous radiation exposure
CAUTION
Laser plume may contain viable tissue particulate
CAUTION
Power supplier should be used the independent 230V, 50Hz. Mains shall
be grounded.
CAUTION
Do not use or keep the device in the place which has much dust and moisture, in the
place reflected by direct rays, or in the place at under 10 °C to 40 °C.
CAUTION
Do not use to the patient in contraindications.
WARNING
All people in the operating room should wear the safety goggles supplied by WON TECH
and the place should be condemned warning mark at entrance of operating room.
WARNING
Do not touch the internal or connected parts of device because high voltages are
used for the device. It may result in an electric shock.
WARNING
Laser should not be exposure directly to the eye and skin because the laser emits the
visible and invisible ray. Wear the protective glasses or goggles before operating the
device.
WARNING
Laser may be radiated onto unexpected place by reflecting and scattering, so do not
use mirror or lustrous metal together with laser which can reflect and scatter the
laser beam.
WARNING
To avoid the RISK of electric shock, this equipment must only be connected to a SUPPLY
MAINS with protective earth.

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WARNING
Power plug is used as the isolation means electrically from the power source on all poles
simultaneously. Do not place the equipment to the difficult position for disconnection.
WARNING
No modification of this equipment is allowed.
NOTE
In the context of this Standard "light" radiation is understood to cover optical
radiation as specified in EN 60825-1:2007.
NOTE
The beam stop according to IEC 60825-1:2007 is replaced by the requirement for a
STAND-BY/READY device.
A risk of fire and/or explosion exists when the LASER OUTPUT is used in the presence of flammable
materials, solutions or gases, or in an eratures produced
in NORMAL USE of the laser equipment may ignite some materials, for example cotton wool when
saturated with oxygen. The solvents of adhesives and flammable solutions used for cleaning and
disinfecting should be allowed to evaporate before the laser equipment is used. Attention should also
be drawn to the danger of ignition of endogenous gases.

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1INTRODUCTION
1.1 Intended Use
The WON COSJET ATR S laser system is intended for the non-invasive Incision, Excision,
Ablation and Vaporization of Soft Tissue for General Surgical Procedures for Coagulation and
Hemostasis.
WARNING: Basically, the WON COSJET ATR S laser system must be operated by a physician
with a qualification of dermatology, nurse or any specialist, and who has been trained on the use of
the product.
1.1.1 Description
The laser system is an effective treatment for dermal pigment lesion which can generate cancer
factors.
1.1.2 Equipment application specification
1.1.2.1 Medical purpose
The WON COSJET ATR S Nd:YAG laser system has extended laser penetration into both
epidermis and dermis without any damage to skin cells
1.1.2.2 Patient population
1) Age: More than 18 years old
2) Weight: Not relevant
3) Health: Not relevant
4) Nationality: Multiple
5) Patient State: Patient is not operator: not relevant, unless patient is agitated.
1.1.2.3 Part of the body or type of tissue applied to or interacted with
1) Treatment site:
-Skin surface
2) Condition: intact skin, treated skin
1.1.2.4 Intended operator
1) Education:
-Dermatologist or physician trained by WON TECH
2) Knowledge:
-Understands laser treatment procedures as a physician or dermatologist.
3) Language understanding:
-English
4) Experience:
-Dermatologist or physician trained by manufacturer.
5) Permissible impairments:
-Impaired by 40% resulting in 60% of normal hearing at 500Hz to 2kHz
-Mild reading vision impairment or vision corrected to log MAR 0.2(6/10 or 20/32)
1.1.2.5 Application
1) Environment
-General:
Intended for professional use
Use at clean room of hospital for treatment

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Use on horizontal floor
-There shall be no hazards of the eye. (All persons in an operational room have to put on the
safety goggles during treatment.)
-When it is functioning, it shall keep its precision.
-Conditions of visibility:
Ambient luminance range: 300~750lux
Viewing distance: 20cm to 40cm
Viewing angle: normal to the display ± 20°
2) Frequency of use:
-Once a week or two weeks for endpoint
3) Mobility:
-It has two handles for movement on rear and front part of the device.
1.2 Applications
The WON COSJET ATR S laser system is a flash lamp pumped, Q-Switched
Nd:YAG(Neodymium-doped Yttrium Aluminum Garnet) laser is near infrared (1064 nm) and
visible (532 nm) pulsed laser output energy are used in these applications. This beam is directed
to the treatment zone by means of the Articulated arm and specially designed handpiece. When
the laser beam contacts human tissue, the energy in the beam is absorbed surrounding skin
structures. The physician can optimize the effect for different applications by controlling the
energy of the laser pulse and the spot size of the treatment beam.
1.2.1 Side effect
Skin lightening (depigmentation): Some dark skinned individuals can develop fading of the skin
color. This complication is temporary and usually resolves within 10-14 weeks. However, there
are times when the complication is permanent.
Skin darkening (hyperpigmentation): In fair skinned people, lasers can sometimes cause
darkening of the skin. Over time this fades and recovers; but in some cases a bleaching agent has
to be used to erase the dark color.
Infections: Sometimes an infection can occur at the site of the tattoo removal. The infection may
be superficial and resolves but in some cases, deep skin infections can occur and result in a scar.
Skin Texture: After laser treatment, most individuals will have a rough skin texture. The skin
will feel like it has been scraped. These changes are transient and usually resolve in 1-3 months.
Thick skin usually resolves better than thin skin. The facial skin is more sensitive to texture
changes than skin elsewhere on the body.
Allergic reactions: Rarely when the laser disrupts the ink particles some individuals may have an
allergic type reaction. It is not known why the reaction occurs and to what ink. The skin usually
becomes red, dry and it itchy. Application of topical corticosteroids will suffice.
Ink darkening: When the laser is applied on cosmetic tattoos, it can worsen or darken the color.
This is most likely felt to be due to the heat of the laser reacting with the cosmetic chemicals. The
changes can be permanent. So before a cosmetic tattoo is treated, a brief test is done to look at the
response. Many an individual has had permanent tattooing of their eye liners.
Sun burn: After every laser procedure, a sunburn effect occurs. The skin appears red and fiery in
some cases. This is a normal and transient- it does resolve within a few weeks. Besides keeping
the area clean, there is no need to apply any ointments or creams, except the sunscreen

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Miscellaneous: Many of the tattoo dyes are unregulated and their exact contents unknown.
Despite this the, complications of laser are rare. A few individuals do develop thickening of the
skin. This thickening known as granuloma is felt to be due to ink particles embedded in
scavenging cells. The granuloma may be small bump on the skin. When lasers are used near the
eye, hair loss and anatomical distortion of the eye lids have been known to occur
1.2.2 Contraindication
Pregnancy, bleeding disorders; immune deficits; heart, liver, and kidney insufficiency; allergies to
local anesthetics; pacemaker and serious heart rhythm disorders; psychiatric disorders; unstable
motivations; large fat volumes; and obesity.
1.3 System Description
1.3.1 Laser System
The WON COSJET ATR S laser system consists of an Nd:YAG laser head, a power supply, a
cooling system, a delivery system and other electrical components. The laser head contains two
Nd:YAG laser medium, and two high-intensity xenon flash lamps enclosed together into the
water cooling housing and two reflected mirrors fixed ,in the special adjustable holders
composed the laser cavity.
To provide energy to the flash lamp, high voltage power supply charges to a storage capacitor.
Then, a trigger pulse applied to the flash lamps causes the capacitor to discharge through the
flash lamps. The resulting flash excites the Nd:YAG laser rod, causing the emission of a pulse of
laser energy.
The electro-optic modulator with a polarizer (Q-switched module) introduced into the cavity
creates the ultra-short (2~40 ns) irradiation pulses. The basic frequency of 1064 nm can be
doubled by a KTP crystal, which can be inserted to a working area. The sealed top metal cover
protects all optical components from dust and humidity and blocks the visible and invisible
scattering light from the laser head.
The system delivers laser energy at a wavelength of 1064 nm and 532nm. The output of the laser
is delivered to the area of treatment through an articulated ARM with a handpiece. A trigger (foot
switch) controls the delivery of pulses. The user selects and sets the treatment parameters and
other functions operated by software on the graphical user interface.
1.3.2 Classifications
Under CDRH regulations in US FDA, the WON COSJET ATR S is classified as a Class Ⅱ
medical device. Under the Medical Device Directive, the WON COSJET ATR S is a Class llb,
non-invasive, active device according to Annex lX of Directive 93/42/EE. Under EN60825-1, the
WON COSJET ATR S laser system safety level is Class 4.
According to EN60601-1(2006), following classifications are applied:
1. Protection against electric shock: Class I ME equipment
2. Type ofApplied Part: B
3. Protection against harmful ingress of water: IPXO (Main Equipment), IPX8 (Foot Switch)
4. Method of sterilization: Not Applicable
5. Suitability for use in an oxygen rich environment: NotApplicable
6. Mode of operation: Continuous

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1.3.3 Beam Delivery System
The articulated ARM is to deliver the Nd:YAG laser energy and the diode laser aiming beam to
the skin surface and handpiece as a distal end for radiation is to radiate the treatment laser and
aiming beam. The output of built-in diode laser is a visible low power beam at a wavelength of
650nm. Since the output laser beam is invisible the aiming beam allows the user to see the
surgical area to which the treatment laser will be delivered.
The articulated ARM consists of seven high reflection mirrors mounted at the special joint ARM
freely rotated in different directions. The handpiece with the focusing lens is mounted at the end
of the ARM. The handpiece provides the adjustability of the beam spot size. The spot size of
handpiece is automatically detected by changing the handpiece dial. The articulated arm with
handpiece unit must always be perfectly aligned.
1.4 Specifications and Requirements
1.4.1 Technical Specifications
Technical Specifications
Laser Type
Q-Switched Nd:YAG Laser
Wavelength:
1064 nm, 532 nm ± 10%
Laser medium:
Nd:YAG
Pulse energy
Genesis Mode
3500mJ
PTP mode
1600mJ
1064nm Mode
1300mJ
532nm Mode
500mJ
Tolerance of pulse energy:
±20%
Energy density(Fluenece)
Genesis Mode
0.1J/cm2to 111J/cm2
PTP mode
0.1J/cm2to 51J/cm2
1064nm Mode
0.1J/cm2to 41J/cm2
532nm Mode
0.1J/cm2to 16J/cm2
Beam delivery:
Articulated ARM with Handpiece
Spot size:
Circle, 2mm to 10mm
Spot size for fractional mode:
5mm x 5mm 9mm x 9mm
Pulse width:
Genesis Mode
80㎲to 480㎲
PTP mode
4ns to 48ns
1064nm Mode
4ns to 48ns
532nm Mode
4ns to 48ns
Pulse frequency:
1Hz to 10Hz
Pilot laser:
Laser Diode, 635nm±5nm, <1mW, selectable intensity, CLASS
3A (IEC60825-1)
User interface:
Touch LCD type
Physical dimensions:
400x805.2x871mm (WxDxH)
Weight:
60kg
Cooling:
Water & Air cooling