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WON TECH WON COSJET ATR S User Manual

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

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  • Page 1 WON COSJET ATR S User Manual WT-UM-08, v4.4 Issue date: April 14, 2015...
  • Page 2 1 The Forrest Units, Hennock Road East Exeter EX2 8RU, UK TEL: +44 1392 826500 FAX: +44 1392 823232 Manufacturer; WON TECH Co., Ltd. 64 Techno 8-ro, Yuseong-gu, Daejeon, Korea TEL: +82 42 934 6800 FAX: +82 42 934 9491 2/55...

  • Page 3: Table Of Contents

    User Manual WT-UM-08 (v4.4) 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 ........................
  • Page 4 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.

  • Page 5: Safety Notes

    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.
  • Page 6 User Manual WT-UM-08 (v4.4) 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"...

  • Page 7: Introduction

    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.

  • Page 8: Applications

    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.

  • Page 9: Contraindication

    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.

  • Page 10: Beam Delivery System

    User Manual WT-UM-08 (v4.4) 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.

  • Page 11: Electrical Specifications

    The input power line should be free of transients (spikes, sags and/or surges). A dedicated branch circuit is recommended. Operation of the WON COSJET ATR S on a power line that is not consistently within the specification may damage the system and may void the warranty.

  • Page 12: Indication, Safety And Reference Symbols

    Keep air-borne dust particles to a minimum. Dust particles can cause permanent damage to optical surfaces. Metallic dust can be destructive to electrical equipment. The WON COSJET ATR S laser system is not suitable for use in the presence of a flammable mixture with air or with oxygen or nitrous oxide.
  • Page 13 User Manual WT-UM-08 (v4.4) Emergency Stop (Emergency Stop switch) Alternate Current Type B Applied Part IPX8 Protected against the effects of continuous immersion in water Foot switch “ON” (power) “OFF” (power) Protective earth (ground) Dangerous voltage Caution Warning Pushing prohibited Sitting prohibited Refer to the chapter 7.1 and 7.2 for the more marking and symbols related to the laser.

  • Page 14: Safety

    HAVE RECEIVED APPROPRIATE TRAINING, AND WHO ARE FAMILIAR WITH THE SAFETY CONSIDERATIONS DISCUSSED IN THIS SECTION. The WON COSJET ATR S laser system has been designed to comply with the requirements of the EC Directive on Medical Products (93/42/EEC). In accordance with this EC Directive, the WON COSJET ATR S laser system qualifies as a class IIb device.
  • Page 15 User Manual WT-UM-08 (v4.4) The laser beam emitted by the WON COSJET ATR S laser system is capable of causing loss of vision. Laser beam energy emitted by this system lies in the visible and invisible, near-infrared region of the electromagnetic waves.

  • Page 16: Laser-Induced Risk Of Fire

    User Manual WT-UM-08 (v4.4) Restrict entry to the laser room when the WON COSJET ATR S laser system is in operation. Limit access to the laser room only to those personnel both essential to the procedure and well trained in laser safety precautions.

  • Page 17: Electrical And Mechanical Hazards

    To unlock the wheels, lift the lever up. The WON COSJET ATR S laser system weighs more than 60 kg and may cause injury if proper care is not used when it is moved. The system is well balanced and is designed to be moved, but it should always be moved carefully.

  • Page 18: Getting Started

    User Manual WT-UM-08 (v4.4) 3 GETTING STARTED 3.1 Scope of Delivery Check the box contents for all supplied accessories according to the packing list enclosed under the top cover of each box. Carefully inspect the device console and all other accessories for any possible damages. This device is provided as below.
  • Page 19 User Manual WT-UM-08 (v4.4) GUI image Articulated arm Spring Type ARM - A type 19/55...
  • Page 20 User Manual WT-UM-08 (v4.4) Weight Type ARM Digital Spring Type ARM Digital Weight Type ARM 20/55...

  • Page 21: Systems Features

    User Manual WT-UM-08 (v4.4) 3.2 Systems Features Front View Articulate ARM: ARM as a delivery system delivers the treatment laser and aiming beam at the distal end of handpiece. ARM consists of mirrors for delivering lasers and 7 joints for freely moving. Zoom Handpiece: Zoom handpiece controls the spot size of treatment laser turning the dial of handpiece.
  • Page 22 User Manual WT-UM-08 (v4.4) Rear View Foot switch terminal: Foot switch connector is connected the terminal to control the treatment laser. The foot switch connector shall be firmly connected to the terminal. Power cable: Power cable supplies electrical energy from mains. The cable shall be connected to mains outlet-socket not sharing with other heavy power-load devices such as refrigerators or air conditioners.

  • Page 23: Articulated Arm

    User Manual WT-UM-08 (v4.4) 3.3 Articulated Arm Spring Type ARM - A type Weight Type ARM Digital Spring Type ARM 23/55...
  • Page 24 User Manual WT-UM-08 (v4.4) Digital Weight Type ARM ① Auto spot cable: The auto spot cable controls the spot size that is indicated on the screen. Tuning the dial of handpiece for spot size change sends a signal indicating the spot size on the graphical user interface.

  • Page 25: Handpiece

    User Manual WT-UM-08 (v4.4) 3.4 Handpiece Spring Type ARM of Zoom HandPiece Weight Type ARM of Zoom HandPiece Digital ARM of Zoom HandPiece ① Connector connecting to the ARM: The connector is connected with Articulated ARM. ② Handpiece tip: The treatment laser is radiated with aiming beam from the distal end of handpiece.

  • Page 26: Explanation Of Term

    User Manual WT-UM-08 (v4.4) 3.5 Explanation of Term Emergency Switch: A switch for shutting down the device in hazardous situations Key Switch: A switch for supplying an electrical energy to the device Foot Switch: A trigger for radiating the treatment laser in Ready mode All people in the operating room for treatment should wear the safety goggles supplied by WON TECH, and there should be a warning mark on the entrance of the place.

  • Page 27: Manu Description

    User Manual WT-UM-08 (v4.4) 3.6 Manu Description 1. LOAD: Loads a saved treatment parameters on the screen. 2. SAVE: Saves the current treatment parameters on the screen. 3. User Mode: Indicates general information of the laser system on the screen. 4.

  • Page 28: Installation

    WT-UM-08 (v4.4) 4 INSTALLATION 1) All components shall be installed by technicians of WON TECH. If you want to reinstall, please call the service center of WON TECH. 2) Connect the Articulated ARM to the mounting hole on the top.
  • Page 29 User Manual WT-UM-08 (v4.4) 4) The lever on the wheels locks the wheels during treatment to prevent hazardous situations from the device movement. Press the lever down to lock the wheel. To unlock the wheels, lift the lever up. NOTE PLEASE MAKE SURE THAT THE EMERGENCY BUTTON IS WITHIN A REACH.

  • Page 30: How To Use

    3. Q-switching mode (532nm, 48ns) 1. For the WON COSJET ATR S laser system, determine the intra-beam MPE for direct ocular exposure to the radiation from a Nd:YAG laser(λ = 1 064 nm) operating at a frequency of F = 1 Hz with a pulse width of t = 0.48 ms at free running mode.
  • Page 31 The NOHD for the rangefinder is therefore 149 m. 2. For the WON COSJET ATR S laser system, determine the intra-beam MPE for direct ocular exposure to the radiation from a Nd:YAG laser(λ = 1 064 nm) operating at a frequency of F = 1 Hz with a pulse width of t = 20 ns at Q-switching mode.
  • Page 32 User Manual WT-UM-08 (v4.4) The pulse width t can be calculated from the condition by 65 × 10 × t = 1.3 –9 –5 giving t = 20 ns (i.e. 10 < t s). The pulse repetition frequency F is 1/1 = 1 Hz. In this example, it is assumed that α...
  • Page 33 User Manual WT-UM-08 (v4.4) 3. For the WON COSJET ATR S laser system, determine the intra-beam MPE for direct ocular exposure to the radiation from a Nd:YAG laser(λ = 532 nm) operating at a frequency of F = 1 Hz with a pulse width of t = 20 ns at Q-switching mode.
  • Page 34 User Manual WT-UM-08 (v4.4) The conclusion is that condition 13.3c) produces the most restrictive MPE per pulse and therefore, –3 –2 = 2.8 × 10 J·m for intra-beam viewing. The range equation of the previous example can be used to calculate NOHD; however, because the mode structure of this solid-state laser is not specified, the pulse energy should be increased by a factor 2.5.
  • Page 35 User Manual WT-UM-08 (v4.4) 2. Main board gets the data on LCD screen whenever user touches the screen and displays the setting value on the screen. 3. While a system operates, the system keeps monitoring whether fan, pump, thermometer and other sensors properly work.

  • Page 36: Start-Up

    User Manual WT-UM-08 (v4.4) 5.1 Start-up 1) Put on the safety goggles for eye protection. Turn on the key switch. Wait a few seconds until the main menu appears on the screen. NOTE IT WOULD BETTER TO PRESS THE MONITOR BUTTON USING NAIL BETTER THAN FINGER TIP.
  • Page 37 User Manual WT-UM-08 (v4.4) In Standby mode, operator controls the treatment parameters and extra functions. After pressing the Standby button to enter in Ready mode, step on the foot switch for radiating the treatment laser. For again entering in Standby mode, press the Ready button. Operator cannot adjust any parameters in Standby mode.
  • Page 38 User Manual WT-UM-08 (v4.4) Depending on the size of treatment zone of patient, set the spot size of zoom handpiece. The spot size on the screen shall be set with matching the spot size adjusted by the dial of zoom handpiece. Pressing the Load button loads treatment parameters saved on the screen.
  • Page 39 ARM. After connecting the fractional handpiece, turn off the device after setting the off mode of Auto spot in the option of User mode. Operator shall purchase the fractional handpiece from WON TECH. Any fractional handpiece other than the fractional handpiece of WON TECH shall not used for treatment. 39/55...
  • Page 40 User Manual WT-UM-08 (v4.4) After turning on the device again, pressing the fractional button on the screen indicates the spot size of fractional handpiece. Power off the device turning the key counterclockwise. 40/55...

  • Page 41: Maintenance

    (5) Handle the Articulated ARM with care. It can cause damage in joint part for connection. (6) Do not move or relocate the device while the power is on (7) When the WON COSJET ATR S laser system is not in use for a period longer than one day, unplug power plug.

  • Page 42: Cleaning Procedure

    User Manual WT-UM-08 (v4.4) Use the laser carefully in the high voltage. Please allow at least 20 cm between the device and the wall. Use appropriate anesthesia cream. Do not touch the device with wet hand. 6.3 Cleaning Procedure Operator (Dermatologist or Physician) or nurse must clean Handpiece tip and safety glass after treatment for patient.

  • Page 43: Technical Customer Service

    If the device seems to be defective or not operated, please contact the service team immediately. Do not try to repair the device by yourself. No modification or dismantle is permitted. WON TECH will not be responsible for any damage that is caused by other than WON TECH certified service team.

  • Page 44: Labeling And Packaging

    User Manual WT-UM-08 (v4.4) 7 LABELING AND PACKAGING 7.1 Labeling of WON COSJET ATR S Package & Label according to ISO15223-1(2012) and IEC60825 44/55...
  • Page 45 User Manual WT-UM-08 (v4.4) 45/55...

  • Page 46: Laser Operation Danger Labels

    User Manual WT-UM-08 (v4.4) 7.2 Laser Operation Danger Labels Laser warning labels according to IEC60825-1 This label informs about the dangers, the Indicating the interlock location maximum values of energy emitted by, and the classification of, the laser source. Laser aperture remarked on the top Notified Beam outlet opening (Laser Aperture).

  • Page 47: Packaging Label

    User Manual WT-UM-08 (v4.4) 60417-5264(DB:2002-10) "ON" for a part of equipment 7.3 Packaging Label Package & Label according to ISO15223-1(2012) Box for Packaging (Dimensions: W 40cm X H 110cm X L 105cm) Keep-upright indicator Shock Watch indicator 47/55...
  • Page 48 User Manual WT-UM-08 (v4.4) Precaution Mark Company name & Product Serial Number 48/55...

  • Page 49: Environment Requirements

    User Manual WT-UM-08 (v4.4) 7.4 Environment Requirements:  Transport and Storage Condition Temperature: - 20 °C to 60 °C Humidity: 0 % to 90 %, Pressure: 70 kPa to 106 kPa  Operation condition Temperature: +10 °C to 40 °C, Humidity: 30 % to 75 %, Pressure: 70 kPa to 106 kPa 49/55...

  • Page 50: Disposal

    WT-UM-08 (v4.4) 8 DISPOSAL The WON COSJET ATR S laser system must be disposed in accordance with WEEE Directive 2012/19/EU of the European Council on Waste Electrical and Electronic Equipment [WEEE]. Please contact our Technical Customer Service Department for help or consultation if required.

  • Page 51: Consumables

    User Manual WT-UM-08 (v4.4) 9 CONSUMABLES 1) Protection Goggles for doctor (2ea)-YL717C NdYAG2  Notified body 0196(CE mark)  Luminous transmittance: 40%  Optical Density:6.0(1064nm), 4.0(532nm), 10.0(355nm), 10.0(266nm)  Storing: The goggle shall be stored at a temperature between -10℃ and +55℃ and a relative humidity of <80% ...
  • Page 52 User Manual WT-UM-08 (v4.4) 2) Protection Goggle for patient (YL-800W SAFETY EYE GUARD)  Notified body 1096(CE mark)  Luminous Transmittance: 0%  This laser goggle protects the eyes of patient against scattered light and diffuse reflection of a laser beam and it gives the user the possibility to protect the laser beam within a certain period of time (max.
  • Page 53 User Manual WT-UM-08 (v4.4) APPENDIX 1 Guidance and manufacturer’s declaration – electromagnetic immunity Compliance Electromagnetic Standards Test level level environment-guidance The EUT was placed on a wooden table, 0.1m height above the floor. The EUT was connected to adaptor and the power of adaptor was fed to Mains terminals...
  • Page 54 User Manual WT-UM-08 (v4.4) Recommended separation distance d = 1.2 P d = 1.2 P 80 MHz to 800 d = 2.3 P 800 MHz to 2.5 where P is the maximum output power rating of the transmitter watts according to the transmitter manufacturer and d is the recommended separation distance in meters (m).
  • Page 55 User Manual WT-UM-08 (v4.4) Power frequency magnetic fields should be at levels characteristic of a typical Power frequency 0.15~80MHz 0.15~80MHz location typical commercial hospital environment. Mains power quality should Dips: that typical Dips: Cycle commercial hospital Cycle >95% environment. If the user of the >95% 5 Cycle at 60% COSJET...

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