Untitled - msc medical
Contents
1. 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 8 43 ILOODA CO LTD FRAXIS CO2 Fractional Laser System User Manual 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 ins2. SAVE after touching the one of the number buttons in STORAGE where you wish to save and setting the values the pop up window as above appears and if you touch OK in the pop up window they are saved in the number As for the adjustment of touch setting amp output sound you control the sound n existence nonexistence by touching the speaker icon in output sound control field After completing the treatment you can go back to main screen by touching BACK in other menu field and if you want to shut down the equipment turn the power off by turning the key switch in main screen and pull out the key ILOODA CO LTD FRAXIS CO2 Fractional Laser System User Manual 1 3 Use of Normal Mode Option norma D P p power el d Parameter Menu Box Li OFF ee ore time A 4 AIMING 1 Ifyou choose Normal on the main screen the Normal screen where respective functions and boxes are arranged appears 2 Set the following menus in parameter menu box using UP DOWN buttons at the bottom mode Shape of energy radiation Setting range CW Pulse single Pulse and Ultra power Strength of energy Setting range 0 5w 30w 0 5w step on time width In case of setting Ultra Time of energy radiation per cycle Setting range The range varies with setting of mode off time frequency In case of setting Ultra Time of no energy ra
3. in the main body This label means the immediate stop of the laser in emergency situations Caution Label This label tells an operator to refer to the user manual carefully ILOODA CO LTD User Manual FRAXIS CO2 Fractional Laser System Chapter 4 Installation of Equipment 1 Description of Equipment 1 1 External Appearance 1 1 1 Main Body Upper Part No Name Function n Articulated Arm Part of Articulated arm connecting part making handpiece Main Body move freely B Scanner Cable Connector Socket connecting scanner C Air Joint Connector Socket passing compressed air through 19 43 ILOODA CO LTD FRAXIS CO2 Fractional Laser System User Manual Front Part No Name Function D LCD Monitor THOCH Touch screen displaying each function and setting E Key Switch Key switch turning on off equipment Emergency stop switch stopping equipment in F Emergency Stop Switch emergency 20 43 ILOODA CO LTD FRAXIS CO2 Fractional Laser System User Manual Back Part No Name Function G Handle Handle used for moving equipment Air Vent Place discharging heat of equipment Air Vent Place discharging heat of equipment J Foot Switch Hook Hook hanging foot switch K Power Cord Connector Socket connecting power cord i ror Comedor Socket connecting foot switch letting set output value out M Remote Interlock Connector Socket
4. 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 D Label Attached to the back of the main body The product amp model name and the required labeling by Medical Device Act are written on this label CO2 Laser Unit co FRX C1 Imp Rating 100 240Vac 50 60Hz 700VA ita CE 2012 03 Please read the user manual carefully before psd use ILOODA Co Ltd Compan 801 805 Venture Valley 958 Gosaek dong Gwonseon gu Suwon Gyeonggi do Korea 441 813 Tel 82 31 278 4660 Fax 82 31 278 4661 HF Sverine AB Klinikutrustning se oe Org number 556709 9964 asust Storgolmsgatan 3 127 48 Skarholmen Sweden Tel 46 8 410 77 900 A See accompanying documents Foot switch IPX1 Continuous operation with Intermittent loading Loading time 5 min Rest time 10 min A To avoid electrical shock do not open the cabinet Refer servicing to qualified personnel only Laser radiation Warning Label Attached to the radiation part of the handpiece Laser radiation Warning 17 43 ILOODA CO LTD FRAXIS CO2 Fractional Laser System User Manual 18 43 Emergency Stop Label Attached to the right of the front side near Emergency Stop Button
5. into scanner mode presenting operating screen necessary for using scanner handpiece Normal Entry into normal mode presenting operating screen necessary for using normal handpiece option lt Information Change of skin type KA Help 29 43 ILOODA CO LTD FRAXIS CO2 Fractional Laser System User Manual 2 Ifyou touch the mode box you want the screen changes into the 30 43 corresponding mode 3 Ifyou wish to shut down the equipment turn the power off by turning the key switch on the current window main screen and pull out the key A Make sure to turn the power on only after the equipment installation is completed If you turn the power on in a situation that the equipment installation is not completed yet or try to entry into some mode the error message appears and the equipment is unable to be operated It is impossible to make a simultaneous entry into the two modes at a time After completing one treatment mode enter into the other mode ILOODA CO LTD FRAXIS CO2 Fractional Laser System User Manual 1 2 Use of Fractional Mode ie E Outout Sound D Parameter Control Field Menu Box e Spot Size 441 dot Control Box E shape scanning storage Up Down Other Menu E AIMING Box A Field 1 Ifyou choose Fractional on the main screen the Fractional screen where respective functions and boxes are arranged appears 2 Set the o
6. not in conformity with the related local law 2 43 ILOODA CO LTD FRAXIS CO2 Fractional Laser System User Manual Table of Contents Chapter 1 Overview 1 Apparatus verification Data 2 Items Provided 3 How to Use This User Manual Chapter 2 Introduction to FRAXIS 1 Introduction to FRAXIS 2 Qualification for Using FRAXIS 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 3 43 ILOODA CO LTD FRAXIS CO2 Fractional Laser System User Manual Chapter 4 Installation of Equipment 1 Description of Equipment 1 1 External Appearance 1 1 1 Main Body 1 1 2 Probe 1 1 3 Accessories 1 2 Installation of Equipment 1 2 1 Installation of Main Body Power Supply Part 1 2 2 Installation of main Body Articulated Arm 1 2 3 Installation of Handpiece Articulated Arm Fractional 1 2 4 Installation of Handpiece Articulated Arm Normal Option Chapter 5 Use of Equipment 1 How to Use at Each Mode 1 1 Power On Off and Use of Main Screen 1 2 Use of Fractional Mode 1 3 Use of Normal Mode Opti
7. 43 A Make sure to set the output values only in STANBY state and change the state into READY state after completing the settings Make sure to change STANDBY into READY and press the foot switch only under which you aim handpiece at the treatment region of a patient because laser is radiated in case that the foot switch is pressed in READY state While the foot switch is pressed and laser is radiated the pop up window notifying radiation of laser as below appears Do not move the handpiece to the other direction x Operation than the treatment region while laser is radiated Make anybody not to access to the foot switch except for an operator doctor ILOODA CO LTD FRAXIS CO2 Fractional Laser System User Manual Chapter6 Equipment Parameters 1 Specification Sheet Laser Mode TEMoo 10 6um Optical Guide Articulated Arm Aiming Beam Semiconductor Diode laser Max 5mW 650mm Optional Accessory Normal Surgical Hand piece F50 F100 Spot Size 0 8mm 0 5mm 38 43 ILOODA CO LTD FRAIS CO2 Fractional Laser System User Manual 2 setting of Parameters for Patients 39 43 ILOODA CO LTD FRAXIS CO2 Fractional Laser System User Manual Chapter 7 Explanations on Error Messages The error message is a warning or notifying pop up message appearing during use or operation If you encounter the following message stop the treatment immed
8. Cautions during Use VI VII VIII Xl XII XII 15 43 Make sure to wear the operator s goggles and patient s eye guards 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 When the failure in the system takes place stop using it and turn off the power and then contact our customer service center In case of a power outage turn off the power immediately and put the controlling knob and switches back to the original position Do not use the equipment near a patient monitor 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 Do not make anybody contact the machine except the patient and the doctor Make the laser beam not radiated directly toward the other people Do not smoke while the laser light is emitted Do not look at the laser light reflecting from a reflector or flashing directly at your eyes Be careful not to install the power cord of another machine at the same time It can cause the performance degradation of the equipment Do not operate the machine in a place where chemicals are stored or gas is generated Do not pull the cord of the main body by f
9. XIS CO2 Fractional Laser System User Manual Off time 10ms 100ms 10ms step 100ms 500ms 20ms step 500ms 1000ms 100ms step 2 ii When Mode is Ultra C ro MD Tox mame inoin IL Set the menu to gt Cart ree fp Frequency width frequency Incase that mode is set to Ultra This is the multi wavelength whose energy radiation unit is us micro sec In this case energy is cyclically radiated according to width time per set frequency while you are pressing the foot switch and power is automatically calculated and presented according to the set values of width and frequency Inactivation Setting range width 100us 200us 10us step 200us 500us 20us step 500us 1000us 100us step frequency 1Hz 20Hz 1Hz step 20Hz 1000Hz 2Hz step 3 After completing the setting of output values of all the menus and then changing STANDBY READY step on the foot switch and radiate laser Refer to 5 of 1 2 Use of Fractional Mode 4 Ifyou wish to save the current settings you can save the setting values in STORAGE Refer to 6 of 1 2 Use of Fractional Mode 5 After completing the treatment you can go back to main screen by touching BACK and if you want to shut down the equipment turn the power off by turning the key switch in main screen and pull out the key 36 43 ILOODA CO LTD FRAXIS CO2 Fractional Laser System User Manual 37
10. ainst Electrical Shock Class 1 Device and B Type Device 3 Laser Hazardous Class by IEC60825 1 2001 Class 4 4 Laser Output Radiation Beam Medium Used CO2 Laser Laser Tube Type All metal sealed off RF CO2 Laser tube Laser Power 30W Wavelength 10 6um Spot Size Max 20mm 20mm Device cooling Air cooling Aiming Beam Medium Used Semiconductor Diode laser Laser Type CW Laser Diode Laser Power Max 5mW Wavelength 650mm 5 Display Display 10 4 Color TFT LCD Panel with CCFL Light 800 600 1 2 Mechanical Specification 1 Dimension 835mm x 410mm x300mm WxDxH 2 Handpiece Length 120mm 3 Weight About 43kg Back 41 43 ILOODA CO LTD FRAXIS CO2 Fractional Laser System User Manual 2 Items to Be Mentioned on Equipment 1 Product Name Laser Surgery Unit A37010 Model Name FRAXIS 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 09 54 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 43 Kg 2 Packing Unit 1 Set 7 Performance and Using Method Refer to the Manual 8 Cautions in Use Refer
11. ce 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 ILOODA CO LTD FRAXIS CO2 Fractional Laser System User Manual 2 13 43 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 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 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 Keep the main body of the equipment the handpieces the connector and the holders in a clean state that has no foreign substances ILOODA CO LTD FRAXIS CO2 Fractiona
12. connecting interlock 21 43 ILOODA CO LTD FRAXIS CO2 Fractional Laser System User Manual 1 1 2 Probe Fractional Handpiece No Name Function Articulated Arm Part Connecting part between handpiece and Articulated a of Handpiece arm b Scanner Connector Connecting socket for movement of socket C Air Joint Connector Socket passing compressed air through Sighting bar for catching a correct region at the time d Sighting Bar of laser radiation e Laser Radiation Part Part from which laser radiates Normal Handpiece Option No Name Function i Articulated Arm Part Connecting part between handpiece and articulated of Handpiece arm g Air Joint Connector Socket passing compressed air through Sighting bar for catching a correct region at the time h Sighting Bar of laser radiation i Laser Radiation Part Part from which laser radiates 22 43 ILOODA CO LTD FRAXIS CO2 Fractional Laser System User Manual Articulated Arm lt n No Name Function j n Scanner Cable Connecting cable for movement of scanner k o Air Joint Cable Cable passing compressed air through Connector connecting main body and articulated Main Body Connector arm Connector connecting handpiece and articulated m Handpiece Connector arm 23 43 ILOODA CO LTD FRAXIS CO2 Fractional Laser System User Manual 1 1 8 Acces
13. diation per cycle Setting range The range varies with setting of mode x One Cycle This is the time point just before the next laser is radiated from the time point when the first laser is radiated while you are pressing the foot switch 34 43 ILOODA CO LTD FRAXIS CO2 Fractional Laser System User Manual According to the setting of mode the menu of parameter menu box is changed into on time off time and Width Frequency and the setting range is also changed 2 i When Mode is CW Pulse single and Pulse o ee MD A 2 e D PUN os i set the menu to or ar O time off time Incase that mode is set to CW This is the continuous wavelength that radiates energy continuously without break and on off time while you are pressing the foot switch setting range On time Inactive Off time Inactive Incase that mode is set to Pulse single This is the single pulse that radiates energy once while you are pressing the foot switch Setting range On time 10ms 100ms 10ms step 100ms 500ms 20ms step 500ms 1000ms 100ms step Off time Inactive Incase that mode is set to Pulse This is the multi wavelength that radiates energy cyclically according to the set time of on off time while you are pressing the foot switch Setting range On time 10ms 100ms 10ms step 100ms 500ms 20ms step 500ms 1000ms 100ms step 35 43 ILOODA CO LTD FRA
14. iately check the content of the message and then readjust the equipment Yerror Screen of Error Message The error message as the left side pops up and the message in the box varies with the content of the error Refer to the following table for the contents of the errors A INTERLOCK ERROR Error message appearing when interlock of INTERLOCK Please check back side of main body is not connected ERROR the interlock Check if it is connected or not and if not ERROR CODE E0401 reconnect it FOOT SWITCH ERROR Error message appearing when foot switch FOOT SWITCH Please check of back side of main body is not ERROR the foot switch connected Check if it is connected or not ERROR CODE E0501 and if not reconnect it LASER ERROR Error message shown when there is a Please check problem with laser module Contact the LASER ERROR the RF Tube Laser OUTPUT service center ERROR CODE E0304 SCANNER ERROR Error message shown when scanner SCANNER Please check connector is not connected or is pulled out ERROR the Scanner in fractional mode Check if it is connected ERROR CODE E1108 or not and if not reconnect it 40 43 ILOODA CO LTD FRAXIS CO2 Fractional Laser System User Manual Chapter 8 Specifications of Equipment 1 Specification of Equipment 1 1 Electrical Specification 1 Rated Power Input Voltage and Consumptive Power 100 240VAC 10 50 60Hz 700VA 2 Protection Type and Degree ag
15. ightly turning the connector clockwise 3 Connect the scanner cable j of articulated arm perpendicularly to the scanner cable connector B of main body in the arrow direction 4 Connect the air joint cable k of articulated arm to the air joint connector C of main body When connecting the articulated arm put it vertically into the connector and turn it clockwise all the way to the end If it is loosely connected the movement of the articulated arm may be unstable When connecting the scanner cable connect it in the arrow direction until you hear the clack sound Loose connection of it to the main body can cause the trouble with the equipment The air joint cable is made of elastic rubber hose Connect it to the air joint connector of main body tightly so that it is not removed from the connector 26 43 ILOODA CO LTD FRAXIS CO2 Fractional Laser System User Manual 1 2 3 Installation of Handpiece Articulated Arm Fractional Refer to the image and numbering of 1 1 2 Probe 1 Put the handpiece connector m of articulated arm horizontally into the articulated arm part of handpiece a and connect it tightly turning it clockwise 2 Connect the scanner cable of articulated arm n horizontally to the scanner connector of handpiece in the arrow direction 3 Connect the air joint cable o of articulated arm to the air joint connector of handpiece c When connecting the artic
16. l 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 10 43 ILOODA CO LTD FRAXIS CO2 Fractional Laser System User Manual 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 fo
17. l Laser System User Manual 2 2 Cautions before Use Make sure to read the instructions and use the equipment before using it Il Make sure to use the equipment on a doctor s prescription Ill 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 14 43 ILOODA CO LTD FRAXIS CO2 Fractional Laser System User Manual 2 3
18. on Chapter 6 Equipment Parameters 1 Specification Sheet 2 setting of Parameters for Patients Chapter 7 Explanations on Error messages Chapter 8 Specifications of Equipment 1 Specifications of Equipment 1 1 Electrical Specification 1 2 Mechanical Specification 2 Items to Be Mentioned on Equipment 4 43 ILOODA CO LTD FRAXIS CO2 Fractional Laser System User Manual Chapter 1 Overview 1 Apparatus verification Data Product Name Medical Laser Equipment Model Name FRAXIS Manufacture Serial Number Date of Manufacture 2 Items Provided The components accessories consisting of this equipment are as follows Mani Body and Handpiece Power Cable Goggles for User Goggles for Doctor Eye Guards for Patient Remote Interlock Contactor Foot Switch amp Cable Power Key User Manual 5 43 ILOODA CO LTD FRAXIS CO2 Fractional Laser System User Manual 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 FRAXIS 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 tells the problem related with the im
19. oom and have all the staffs of a hospital well informed of the proper laser use protocol 11 43 ILOODA CO LTD FRAXIS CO2 Fractional Laser System User Manual 1 2 Electrical Hazard 12 43 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 1 3 Fire Hazard 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 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 tio or handpie
20. orce It can cause the performance degradation of and the trouble with the machine ILOODA CO LTD FRAXIS CO2 Fractional Laser System User Manual 2 4 Cautions after Use After use put the control Knob and switches back to the original position and turn off the power Be careful not to give an excessive force to the connecting part of cords when you pull out the cords 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 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 Do not keep the equipment in a place where chemicals are stored or some gas is generated 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 16 43 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 Never open the machine and the controller 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 ILOODA CO LTD FRAXIS CO2 Fractional Laser System User Manual 3 Labeling The
21. pe m A O L j High power CO2 Fractional Laser System f es i aa 1 N a j Qg a ai E ia k i ERa F P a a pe k tg P practionat K noma l las er LE SY ste onl reg ardless skin type E An a EJ The comp lete sol utio n of aesthe etic treatment FRAXIS CO2 Fractional Laser System User Manual 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 sales ilooda com Please check the related local regulations before using the equipment The use of the apparatus may not be permitted if it is
22. proper 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 that can use CO2 laser Fractional mode and Normal A N mode option and the explanation on the system related with option can be omitted In addition the function and screen menu are subject to change according to the options of the handpiece 6 43 ILOODA CO LTD FRAXIS CO2 Fractional Laser System User Manual Chapter 2 Introduction to FRAXIS 1 Introduction to FRAXIS Made by mixing laser and scanner FRAXIS is a laser equipment to conduct Micro Fractional Laser Resurfacing promoting the reconstruction of both epidermis and dermis by radiating numerous micro laser beams in many divided sections into skin tissues x What is Micro Fractional Resurfacing This is a treatment method which radiates laser beams dividing them into tinier sections than hair into skin surface partially to generate a
23. r 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 tyoes 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 r
24. rtificial thermal damage gets normal skin tissues to recover the laser damaged skin tissues quickly without any side effects and then makes new skin tissues through this process When laser is emitted into skin in innumerable minute points thousands of tiny holes that can be hardly seen with the naked eye are formed This treatment is to make the thermal plume that generated these holes stimulate the epidermis and dermis of skin and to regenerate collagen rapidly This treatment doesn t affect our daily lives and gets normal tissues to create new tissues because only 10 45 of concerned skin area is treated leaving normal tissue untouched Therefore with this equipment you can see not only the improvement of skin elasticity and tone and pores but also the removal of scars and wrinkles x Applications of FRAXIS Acne scars Burn scars Surgery scars Aging skin lesions Pigmentary disorders Freckles Dark and dull skin Expanded pores Wrinkles Decline of skin elasticity Striae distensae Various skin renewal Skin total renewal around face and neck 7 43 ILOODA CO LTD FRAXIS CO2 Fractional Laser System User Manual 2 Qualification for Using FRAXIS 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
25. sories The accessories comprising this equipment are as follow Power Cable Power Key Operator s Goggles Doctor s Goggles Patient s Eye Guards Remote Interlock Foot Switch amp Cable User Manual 24 43 ILOODA CO LTD FRAXIS CO2 Fractional Laser System User Manual 25 43 1 2 Installation of Equipment 1 2 1 Installation of Main Body Power Supply Part Refer to the image and numbering of Back Part in 1 1 1 Main Body Connect the power cord to the power cord connector K at the back side of the main body Put the remote interlock into the remote interlock connector M at the back side of the main body Connect the foot switch to the foot switch connector N at the back side of the main body The foot switch and remote interlock are distinguished by their colors to prevent confusion between the two connectors Put them respectively into each connector with the same color as theirs in the arrow direction ILOODA CO LTD FRAXIS CO2 Fractional Laser System User Manual 1 2 2 Installation of Main Body Articulated Arm Refer to the Upper Part in 1 1 1 Main Body and the image and numbering of articulated arm in 1 1 2 Probe 1 Open the red protective cap of main body s articulated arm part A 2 Put the main body connector I of articulated arm perpendicularly into the articulated arm part of main body and connect them t
26. t cable is made of elastic rubber hose Connect it to the air joint connector of main body tightly so that it is not removed from the connector There are two types of the normal handpieces according to focal length from the lens to the target which are f 50mm and f 100mm The focal length corresponding to each handpieces are imprinted on the articulated connecting parts of the normal handpieces f50mm f 100mm Make sure to use the normal handpiece only in the normal mode Change of handpiece once after you enter into each mode can bring about errors with the system Make sure to exchange the handpiece only in the main screen 28 43 ILOODA CO LTD FRAXIS CO2 Fractional Laser System User Manual Chapter 5 Use of Equipment 1 How to Use at Each Mode Refer to 1 2 Installation of Equipment of Chapter 4 and install the equipment All the operating modules and displays appear on the LCD monitor A at the front of the main body Operate the machine by touching the touch screen monitor 1 1 Power On Off and Use of Main Screen Turn on the power by connecting the power and turning the key switch 1 The pop up SYSTEM ALERT as below appears when you turn the power on and about 2 3 seconds later the main screen in which two touch boxes are arranged is shown Ss Ys Tem ks See eer ql After 2 3 seconds ErAXIS E eractionat X NOMAL Fractional laser system ASSA Fractional Entry
27. talling 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 9 43 ILOODA CO LTD FRAXIS CO2 Fractional Laser System User Manual 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 manua
28. to the Manual 9 Rated Power and Voltage 1 Rated Electricity 100 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 42 43 ILOODA CO LTD FRAXIS CO2 Fractional Laser System User Manual 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 43 43 ILOODA CO LTD
29. ulated arm put it vertically into the connector and turn it clockwise all the way to the end If it is loosely connected the movement of the articulated arm may be unstable When connecting the scanner cable connect it in the arrow direction until you hear the clack sound Loose connection of it to the main body can cause the trouble with the equipment The air joint cable is made of elastic rubber hose Connect it to the air joint connector of main body tightly so that it is not removed from the connector Make sure to use the fractional handpiece only in the fractional mode Change of handpiece once after you enter into each mode can bring about errors with the system Make sure to exchange the handpiece only in the main screen 27 43 ILOODA CO LTD FRAXIS CO2 Fractional Laser System User Manual 1 2 4 Installation of Handpiece Articulated Arm Normal Option Refer to the image and numbering of 1 1 2 Probe 1 Put the handpiece connector m of articulated arm horizontally into the articulated arm part of handpiece f and connect it tightly turning it clockwise 2 Connect the air joint cable o of articulated arm to the air joint connector of handpiece g When connecting the articulated arm put it horizontally into the connector and turn it clockwise all the way to the end If it is loosely connected the movement of the articulated arm may be unstable The air join
30. utput value by touching the following menus one by one in parameter menu box Touch the menu you wish to set and then adjust the output value using up down at the bottom left duration Energy radiation time per pixel Set range 100us 5000us repeat Time interval between energies areas radiated repeatedly while you are putting on foot switch Set range single 0 2s 0 5s 0 s 1 0s 1 5s and 2 0s overlap Number of lasers radiated per pixel Set range 1st 10th distance Distance between pixels Set range 0 1mm 2 0mm shape Shapes of radiated lasers area at scanning Directions and styles of radiated lasers 31 43 ILOODA CO LTD FRAXIS CO2 Fractional Laser System User Manual 3 After setting the menu adjust the energy size to be radiated in spot size control box Adjust the size to one you want by touching the arrows and triangle shaped buttons in the box Set range Imm 20mm respectively in width and length 1step Four directional size adjusting button You can adjust the size upward downward or to the left right by touching this button and then white triangle buttons 77 71 b Fixed rate size adjusting button You can adjust the size upward downward or to the left right in the same proportion by touching this button and then white triangle buttons x On the bottom left of the spot size bo
31. x the dot says the quantity of the radiated laser and the says the ratio of the radiated laser It is shown from the system user cannot control them arbitrarily Dot the quantity of the radiated laser on the setting area the ratio of the radiated laser on the setting area 4 After controlling the spot size set the aiming beam representing the shape and region that laser is radiated The pop up window as below appears as you touch AIMING of other menu field If you touch OK after adjusting the brightness of aiming beam using Aiming Beam the arrows in the pop up window the setting is completed and the screen is changed into the mode screen and if you touch CANCEL the setting is cancelled and the screen is changed into the mode screen Set value 1 10 1 step 32 43 ILOODA CO LTD FRAXIS CO2 Fractional Laser System User Manual 33 43 If you touch STANDBY of outout sound control field after completing the setting of all the menu output values the standby state is converted into the ready state as the purple color is changed into the orange color At this time if you step on the foot switch laser is radiated STANDBY gt READY STANDBY READY Laser radiation Standby Ready If you wish to save the set values you can save them by using STORAGE of other menu field If you touch N do you want saver
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