OmniLight Users Manual
Contents
1. The handpiece consists of an enclosed optical system which emits the pulse of light through a filter and into the sapphire waveguide The handpiece is an ergonomic design which is easy to hold with only one hand and comfortable for the user 1 4 Indications for Use The OmniLight FPL Pulsed Light System can be used for Hair removal for all skin types including permanent hair reduction Treatment of vascular lesions Treatment of benign pigmented lesions Acne treatment not FDA approved Tattoo removal American Medical Bio Care Inc Page 9 Copyright 2003 All rights reserved OmniLight FPL User s Manual Section 2 Safety This chapter describes safety issues regarding the use of the OmniLight FPL Pulsed Light System with emphasis on optical and electrical safety WARNING Use or adjustment of controls or implementation of procedures other than those specified herein may result in hazardous radiation exposure Physicians and other personnel operating or maintaining the OmniLight FPL system should read this manual and become thoroughly familiar with all safety requirements and operating procedures before attempting to operate the system 2 1 Introduction The OmniLight FPL Pulsed Light System has been designed for safe and effective treatments With proper use and maintenance the system can be operated safely by trained qualified physicians and licensed practitioners The primary considerations s2. To begin a new treatment select parameter settings filter type fluence pulse mode pulse duration and sapphire temperature For information on safe starting parameters please see Appendix A Larger areas to be treated should be broken up into quadrates approximately 6 x 6 cm 2 1 3 x 2 1 3 Use a orange yellow marker to draw the lines Prepare one of these quadrates with a thin layer of gel about 0 5 1mm thick The gel should be applied to only one area 6 x 6 cm or 2 1 3 x 2 1 3 ata time and each area must be treated and the gel removed before gel is applied to the next quadrate Place the end of the lightguide in contact with the prepared skin Once the handpiece is in position carefully depress the trigger button on the handle Move the end of the lightguide to the next adjacent spot ensuring that it lines up with the previously treated areas Use the footprint of the lightguide in the gel to discern skin that has already been treated While it is not dangerous to overlap it is not recommended This could cause an accumulation of pulse energy in the overlapped areas American Medical Bio Care Inc Page 32 Copyright 2003 All rights reserved OmniLight FPL User s Manual Apply a thin layer of contact gel to the next portion to be treated and repeat the above procedures until the entire desired area has been treated Once the whole area has been treated replace the handpiece in its holder Clean th
3. Information about the therapeutic application is provided in Appendix A WARNING Dangerous voltages are present inside the unit If the covers are removed interlock switches will prevent the unit from being operated The handpiece should be placed in the holder during machine start up The OmniLight FPL emits pulsed light Everyone present in the room must be wearing appropriate protective eyewear Never look directly into the lightguide even when wearing protective eyewear Never direct the light pulse at anything other than the targeted area WARNING Delivering excessive energy to the treatment site can result in thermal damage to the skin possibly resulting in hypertrophy atrophy or abnormal pigmentation or the combination of all three American Medical Bio Care Inc Page 26 Copyright 2003 All rights reserved OmniLight FPL User s Manual 5 1 Control Panel The OmniLight FPL Pulsed Light system is operated by pressing the three keys pads located on the control panel The key functionality is menu sensitive The Control Panel is used for selecting the Pulse forming mode Standard Pulse Forming SPF or Advanced Pulse Forming APF Fluence displayed in Joules per centimeter squared J cm The pulse width displayed in milliseconds ms 5 2 Start up Start up the cooler 3 5 minutes before the treatment to reach operating temperature Insert the Calibration Key Card Swit
4. OmniLight FPL User s Manual American Medical Bio Care Inc does not recommend treatment on children below the age of 16 years because the hair follicles and endocrine system are not fully developed The number of treatments varies due to dissimilarity between people and hair follicles in different areas of the body most likely because of the location and number of germinative cells that must be destroyed to achieve permanent hair reduction The level of pain perception varies between different people and various skin areas The best means for pain control is keeping the sapphire at low temperature and in some cases extend the pre cooling time sapphire in skin contact time before pulse up to 1 2 seconds The pain may also be reduced by applying a firm skin pressure with the sapphire to reduce the amount of blood in the treated area Blond red waxed or very thin hair is less likely to respond to the treatment than dark and thick hair because there is less target to absorb the light energy and create the heat that destroys the germinative cells responsible for re growth In cases of recently waxed hair a minimum of 2 months should elapse before beginning treatment with the OmniLight FPL This will provide enough time for every hair to redevelop and become a target 2 0 Test Patch It is recommended to spend the first visit with the patient imparting information and carrying out tests of 3 5 patches These patches sho
5. Switch off power supply Disconnect ALL cabling and or plugs Wear insulation gloves Short capacitors to ground CAUTION Federal USA law restricts this device to sale by or on order of a physician or any other practitioner licensed by the law of the state in which he practices to use or order the use of the device Page 13 OmniLight FPL User s Manual 2 3 Operational Safety The following guidelines should be followed to ensure good optical safety Wear protective eyewear to guard against accidental exposure Post a warning sign on the treatment room door Do not allow access to the treatment room except to essential personnel who are trained in the safety requirements Never look directly at the pulsed light being emitted from the handpiece Do not use the treatment head in any other way than that which is specified in this manual Do not perform treatments in the presence of explosive anesthetics or other flammable materials Only direct the light at the targeted treatment area Never place reflective objects in the light path including jewelry watches surgical instruments or mirrors 2 4 Electrical and Mechanical Safety Keep the covers to the console in place at all times Never leave the unit turned on while unattended The OmniLight FPL Pulsed Light System weighs approximately 38 kg 84 pounds and may cause injury if care is not taken when moving it The unit is grounded thro
6. Bio Care Inc Page 35 Copyright 2003 All rights reserved OmniLight FPL User s Manual Using the filter tool put the caps back on the handpiece and ensures that each cap is rotated 90 degrees Properly dispose of the old flashlamp American Medical Bio Care Inc Page 36 Copyright 2003 All rights reserved OmniLight FPL User s Manual CAUTION Do not touch the glass portion of the flashlamp at any time as this may leave oil on the surface and cause flashlamp damage or alter the performance of the system 6 4 Changing the Filter The filter operates by transforming non effective wavelengths into peaks that are beneficial during treatments This fluorescence enhances the overall effect and The control panel filter counter will indicate when filter has to be changed When the filters are received they are in a packet of 50 filters The filters have a small amount of optical lubricant on them This should not be removed and should be smeared on both sides of the filter Open the lightguide by loosening the two small black levers Place the filter halfway into the opening Rotate the levers back to the lock position and press the filter the rest of the way into the holder You should NEVER look directly into lightguide during this or any other procedure If an old filter is still in place it will slide out the other side during insertion of the new one Tip If a used filter is difficult to rem
7. Spot size 20 x 20 mm Fluence up to 35 J cm Est lamp life 10 000 pulses Skin Rejuvenation SR Handpiece Spot size 20 x 10 mm Fluence up to 70 J cm Est lamp life 10 000 pulses System console Dimensions 32 x 33 cm footprint x 135 cm high 12 x 12 x 52 Weight 38 kg 84 lbs Repetition Rate Up to 1 pulse per second Optical system Sapphire lightguide User interface Monochrome LCD panel with push button control Power supply requirements 100 120 VAC 16 A 50 60 Hz or 200 240 VAC 8A 50 60 Hz Environmental Conditions Operating temperature 10 C 30 C Storage Temperatures 0 C 55 C American Medical Bio Care Inc Page 19 Copyright 2003 All rights reserved OmniLight FPL User s Manual Operating Relative humidity Up to 80 Storage Relative humidity Up to 90 Cooler System Temperature range 5 to 25 C accuracy 1 5 C Cooling device Cooling collar attached to the sapphire light guide Dimensions 15x25 footprint x 45cm height 6 x 10 x 18 Weight 10 kg 22 Ibs Cooling media Water glycol solution User interface Monochrome LED panel with four push button control Power supply requirements 90 240 VAC lt 400 VA 50 60 Hz Environmental Conditions Operating temperature 10 C 30 C Storage Temperatures 0 C 55 C Operating Relative humidity Up to 80 Storage Relative humidity Up to 90 American Medical Bio Care Inc Page 20 Copyright 2003 All right
8. near the base gently lift the unit out of the case The handpiece is packaged in the large case Energy meter and lamp filter and other accessories are packaged in the small two cases Once you have checked to make sure the system is properly configured to your wall voltage section 4 3 plug one end of the mains cable into the bottom of the device and the other into a wall jack Before starting the device check that sufficient coolant water is in the machine de ionized de mineralized water ONLY see section 6 5 Filling and Changing the Coolant Water American Medical Bio Care Inc Page 24 Copyright 2003 All rights reserved OmniLight FPL User s Manual 4 6 Moving the System To move the system within the facility Switch off power Disconnect the power cord to Power cube Disconnect the two cooling liquid connectors on the rear of the OmniCool Insure that the handpiece is secured in the hanger Grip the handle on the back and tilt the unit backwards app 20 30 deg Slowly pull the unit Never touch the screen panel If the OmniLight FPL Pulsed Light System needs to be moved to another facility itis highly recommended to use the original packaging American Medical Bio Care Inc Page 25 Copyright 2003 All rights reserved OmniLight FPL User s Manual Section 5 Operation This section contains the operating instructions for the OmniLight FPL Pulsed Light System
9. objective comparison of photos taken at different times 8 5 Side Effects of Treatment The most common side effects are Discomfort When a pulse is triggered it may cause various degrees of discomfort Some describe the sensations as stinging while other liken it to a rubber band snap A burning sensation may last for up to an hour after treatment Most adults and older children are able to tolerate this discomfort but some may require a topical anesthetic Damage to the skin A crust or blister may form which may take from texture five to ten days to heal As with any wound that results in a crust or blister improper care could lead to long term or permanent textural changes Change in There may be a change in pigmentation in the pigmentation treated area Most cases occur in people with darker skin or when the treated area has been recently exposed to sunlight In some people hyper pigmentation occurs despite protection from American Medical Bio Care Inc Copyright 2003 All rights reserved Page 45 OmniLight FPL User s Manual the sun Such discoloration usually fades in three to six months but in rare cases the change of pigment may be permanent Scarring There is a very small chance of scarring such as enlarged hypertrophic scar or in very rare cases abnormal large raised keloid scars mainly in people who have a pre disposition to these conditions To reduce the
10. the OmniLight FPL console at least once a week Wipe surfaces with a soft damp non abrasive cloth Mild cleansing solution may be used Be careful not to spill any liquids on the unit 6 2 Cleaning the Sapphire Lightguide Before each application of the OmniLight FPL the lightguide should be cleaned First dry it with a lint free cloth and then with a cloth moistened with ethyl alcohol or isopropyl 70 alcohol Let the lightguide dry thoroughly before using Do not use acetone or any product that could dissolve plastic 6 3 Changing the Flashlamp Turn the power switches OFF before beginning this process Remove the end caps on the handpiece using a coin or the edge of the filter tool as a screwdriver Place the small end of the filter tool into the bottom of the handpiece hanger Slowly put the handpiece back in the hanger with the filter tool aligning against on the bottom of the flashlamp American Medical Bio Care Inc Page 34 Copyright 2003 All rights reserved OmniLight FPL User s Manual Push the flashlamp out of the handpiece slowly and grab it with your fingers and remove it completely A small amount of water may come out but this is normal Remove the handpiece from the hanger Take a new flashlamp and put a small amount of de ionized water on it Insert the small end of the flashlamp into the top of the handpiece and push it slowly and carefully into place until firmly seated American Medical
11. treatment and repeat the test patches with lower energy levels during another session after 1 2 weeks Ideally the patient should be asked to return after 3 5 days for evaluation and the first treatment In those areas where the hair has fallen out the energy used is sufficient In some cases you may need to test the results by pulling on the hair with a pair of tweezers If the hair comes out with little or no resistance then the energy used was sufficient If not it is advisable to increase the energy by increasing the fluence 3 5 J cm steps If in doubt use another trial area to test the higher energy 3 0 Preparation of the treatment area It is important to properly prepare the hair and skin in the region to be treated Good preparation will enhance the treatment and ensure reliable results Before the treatment remove excess hair from above the surface of the skin by shaving One should leave a 1 mm stub to pull from with tweezers for testing the result American Medical Bio Care Inc recommends a light shave using an electric beard trimmer It is always a good idea to clean the skin after shaving to remove any possible dirt hair or make up Such specs although small can cause part of the light to be focused into a small area of skin which may feel uncomfortable and or cause damage American Medical Bio Care Inc Page 49 Copyright 2003 All rights reserved OmniLight FPL User s Manual When larg
12. American Medical Bio Care Inc omnilight User s Manual OmniLight FPL User s Manual Physician Responsibility United States federal law restricts prescription medical devices to sale by or on the order of a physician or properly licensed practitioner AMBC makes no representation regarding state or local laws or regulations that might apply to the use and operation of any medical device The Physician is responsible for contacting his or her local licensing agencies to determine any credentials required by law for clinical use and or operation of the device Maintenance The OmniLight FPL Pulsed Light System is a medical device that requires routine service as well as consumable parts All service must be performed by either a AMBC technician or a technician trained by AMBC Failure to obtain service and parts from Luxsano or its authorized distributors voids all warranties express and or implied Modification of the Device Unauthorized modification of the hardware software or any other specification of the OmniLight FPL Pulsed Light System voids all warranties express and or implied Luxsano accepts no responsibility for the use of a modified device Resale The OmniLight FPL Pulsed Light System is a technically advanced medial device If any device is resold by anyone other than an authorized sales representative AMBC offers a resale inspection by a trained technician to ensure that the device is working according to s
13. BLE OF CONTENTS Section 1 System Overview 1 1 Use Principle 1 2 Unique FPL features 1 3 System Basics 1 4 Indications for Use Section 2 Safety 2 1 Introduction 2 2 Cautions and Warnings 2 3 Operational Safety 2 4 Electrical and Mechanical Safety 2 5 Fire Hazards 2 6 Safety Features Section 3 Description 3 1 System Components and Controls 3 2 Software 3 3 Specifications Section 4 Installation 4 1 Equipment List 4 2 Facility Requirements 4 3 Electrical Requirements 4 4 Environmental Conditions 4 5 Installation 4 6 Moving the System 5 1 Control Panel 5 2 Start up 5 3 Treatment 5 4 Pulse Counter 5 5 Turing off the system Section 6 Maintenance and Troubleshooting 6 1 Cleaning the Unit 6 2 Cleaning the Sapphire Lightguide 6 3 Changing the Flashlamp 6 4 Changing the Filter 6 5 Filling and Changing the Cooling Water 6 6 Changing the Handpiece 6 7 Troubleshooting 6 8 Error Codes Tl Protective Eyewear 7 2 Coupling Gel 7 3 Lamps and Filters 74 Optional Handpieces 7 5 Ordering Accessories American Medical Bio Care Inc Page 5 Copyright 2003 All rights reserved OmniLight FPL User s Manual Section 8 Physician Information 8 1 Training Requirements 8 2 Indications and Contra Indications 8 3 Pretreatment Preparation 8 4 Photography 8 5 Side Effects Appendix A Hair Removal Appendix B Skin Rejuvenation American Medical Bio Care Inc Page 6 Copyright 2003 All rights reserved OmniLigh
14. at the system be connected to a separate power line with separate circuit breakers AMBC cannot guarantee optimum performance unless the OmniLight FPL Pulsed Light System is connected to a dedicated circuit The 2 main fuses are located in the mains inlet receptacle on the power cube e CAUTION Before turning on your system the first time verify that the OmniLight FPL Pulsed Light System is wired for the appropriate line voltage for your country by checking the label located on the Power cube that converts wall plug voltage to appropriate level for the Console unit 4 4 Environmental Conditions The OmniLight FPL Pulsed Light System should operate in a non corrosive atmosphere Airborne dust particles should be kept to a minimum To ensure that the OmniLight FPL Pulsed Light System operates optimally it is recommended to maintain a room temperature between 20 C and 25 C with relative humidity of less than 80 4 5 Installation American Medical Bio Care Inc Page 23 Copyright 2003 All rights reserved OmniLight FPL User s Manual In order to ensure proper assembly and optimal working conditions please follow these instructions for removal and basic set up Lay down the transportation box on the floor Open the box Remove the two foam plastic holders from the console foot and top This will release the console unit and three cases inside Grabbing the bottom of the device and the rear of the tower
15. ave any hair in the area to be treated When larger areas are to be treated American Medical Bio Care Inc recommends that you mark the skin area in sectors of 6 X 6 cm 2 1 3 x 2 1 3 using a red marker pen Note it is enough to use dotted lines Next apply coupling gel to one sector at a time and begin treatment American Medical Bio Care Inc Page 5 4 Copyright 2003 All rights reserved OmniLight FPL User s Manual 4 0 Pulse Width Choosing the correct pulse is essential for a successful treatment The total pulse burst duration should primarily be adapted to the typical thickness of the target For example treatment of epidermal pigmentations and superficial vascular lesion will respond best to a pulse duration that is relatively short typically in the range 25 50 ms while pigmentations and vascular lesions that is thicker or deeper preferably is treated with longer pulse durations typically in the range of 40 150 ms The time it takes for an object to cool is a function of that object s size Cooling time is shorter for small objects and longer for large objects The OmniLight FPL takes advantage of this thermal selectivity i e longer cooling time of a relatively large object thickness or diameter and shorter cooling time of the thinner epidermis It does this by structuring each macro pulse as a series of micro pulses with a relatively short delay in between Ideally excessive heat generated in the
16. ch on the OmniLight using the main power switch at the upper left corner on the back of the main body You will hear a quiet hum as the water pump and cooling fans engage American Medical Bio Care Inc Page 27 Copyright 2003 All rights reserved OmniLight FPL User s Manual The Lamp and the Calibration Card are matched thus insuring that the Output is standardized and optimal treatment results can be achieved Each Lamp is serialized and the corresponding Calibration Card has the same serial number Always make sure that the Lamp and Calibration Card are matched The LCD display will light up The system will automatically go through a start up routine The display will show the basic product information including the product name OmniLight FPL the application type HR SR etc and the software serial number versions These items will display for 2 seconds American Medical Bio Care Inc Page 28 Copyright 2003 All rights reserved OmniLight FPL User s Manual The user will then be given a choice between Standard SPF or Advanced APF pulse forming mode In each mode both the Fluence J cm and the pulse duration ms can be adjusted The display will also indicate if the correct handpiece HR SR VL etc is attached If the incorrect handpiece is attached a message Wrong Handpiece will be displayed on the LCD panel If so turn off the machine using the main power sw
17. change of scarring it is important to carefully follow all post treatment instructions Excessive swelling Immediately after treatment especially of the nose and cheeks the skin may swell temporarily Swelling usually subsides quickly but sometimes in three to seven days Fragile Skin The skin at or near the treatment site may become fragile If this happens make up should be avoided and the area should not be rubbed as it may tear the skin American Medical Bio Care Inc Copyright 2003 All rights reserved Page 46 OmniLight FPL User s Manual Appendix A Treatment Hair Removal The OmniLight FPL Pulsed Light System uses fluorescent pulsed light for hair removal The OmniLight FPL eliminates hair employing a method known as selective photothermolysis This involves disabling hair regrowth mechanism by raising the temperature of the hair follicle high enough to irreversibly damage the follicle s germinative cells without damaging the epidermis and the surrounding tissue The germinative do reside inside the follicle but is located to the outer follicles sheath Therefore the complete follicle volume must be heated above 70 C to accomplish permanent destruction of all stem cell Hair on different parts of the body is of different depths for instance upper lip or mustache hair follicles are 1 to 2 5 mm deep while axillae or pubic hair follicles are 3 5 to 4 5mm deep Hairs with deep la
18. e skin by sweeping off excessive gel with a spatula If necessary smear treated area with appropriate cream e g Aloe Vera lotion Record the treatment parameters in the patient s file It is recommended that the patient return several weeks after treatment for examination of the treated site and continuation of treatment if necessary 5 4 Turning off the system Turn off the OmniLight FPL Pulsed Light system by using the main power switch The shut down process is immediate Remove CalCard and put in a safe place Lost CalCard will not be replaced free of charge Turn off the complete system including the cooler at the end of each workday American Medical Bio Care Inc Page 33 Copyright 2003 All rights reserved OmniLight FPL User s Manual Section 6 Maintenance and Troubleshooting This section describes routine maintenance procedures performed by the user Cleaning the unit cleaning the lightguide replacing the filter and replacing the flashlamp The procedures listed in this section are the only maintenance activities you should perform All other service procedures are to be performed only by the company s authorized service personnel i WARNING Maintenance by the user should be performed only when the unit is shut down and disconnected from power Performing maintenance procedures with the system ON can be hazardous to you and or cause damage to the system 6 1 Cleaning the Unit Clean
19. ed instead if Omnicool if it is adapted to AMBC s proprietary sapphire cooling collar One system support kit contains Power cords DI water fill bottle funnel Gel with spatula applicator Protective eye wear for patient Protective eye wear for operator American Medical Bio Care Inc Page 21 Copyright 2003 All rights reserved OmniLight FPL User s Manual DI water draining connector and hose User s manual 4 2 Facility Requirements Prior to unpacking the OmniLight FPL Pulsed Light System ensure that the site meets the following requirements Space The physical dimensions of the system are 33 x 32 x 135cm 1x 1 x 4 25 ft Place the system away from heating ducts and other outlets Keep at least 60 cm 2 ft of free space around all sides of the system 4 3 Electrical Requirements The OmniLight FPL Pulsed Light System is pre wired at the factory for the local line voltage specified by the customer at the time of order Accordingly the unit will require a separate line supply of at least Standard US 110 V AC 10 16A 50 60 Hz or Standard Japanese 100 V AC 10 16A 50 60 Hz or Single phase 230 V AC 10 8A 50 60 Hz or American Medical Bio Care Inc Page 22 Copyright 2003 All rights reserved OmniLight FPL User s Manual The power supply line should not be shared with other heavy variable load equipment such as elevator or air conditioners It is recommended th
20. el American Medical Bio Care Inc recommends the application of moisturizing lotion on the treated area twice a day for one week after each session 8 0 Immediate Normal Response After Treatment Medium to strong peri follicular edema erythema Appearance of mild erythema edema over the treated area A brownish tint in the gel Skin tightening 9 0 Follow up The patient should return several 2 3weeks after treatment for examination or at least report the outcome The hair shall be lost in 7 12 days after the treatment If not the treatment has not been effective and higher fluency has to be used in the next session If no additional treatment is necessary the patient should return for an additional re examination three to four weeks later If no change is noted the Fluence for the next treatment should be increased at least 10 20 American Medical Bio Care Inc Page 52 Copyright 2003 All rights reserved OmniLight FPL User s Manual Appendix B Treatment Skin Rejuvenation The OmniLight FPL Pulsed Light System uses fluorescent pulsed light for skin rejuvenation Skin rejuvenation can be defined as improvement in the appearance of skin by removing age spots sun induced freckles benign brown pigmentation and redness caused by flushing or broken capillaries The OmniLight FPL employs a method known as selective photothermolysis to selectively destroy targets in the skin allowing the body to remo
21. en removed to replace the flashlamp an interlock shuts down the power to the system to prevent accidental electrical shock Stand By Sleep Mode If the unit has not been used for ten minutes it will automatically go into a stand by mode which will prevent accidental emission of energy and save power Pressing the left of the three panel buttons will take user back to the main menu American Medical Bio Care Inc Page 15 Copyright 2003 All rights reserved OmniLight FPL User s Manual Ready Indicator During use a beep will sound each time the unit is ready to fire a pulse American Medical Bio Care Inc Page 16 Copyright 2003 All rights reserved OmniLight FPL User s Manual Section 3 System Description 3 1 System Components and Controls The OmniLight FPL Pulsed Light System consists of four major components System Console Power Cube Unit transformer unit Handpiece External Sapphire Cooler required accessory American Medical Bio Care Inc Page 17 Copyright 2003 All rights reserved OmniLight FPL User s Manual System Console The console contains the electrical components required for operation of the system Handpiece The handpiece houses the mechanisms that generate the light pulse It is connected by an umbilical cord containing the wiring and tubing that carries water to assist in cooling A sapphire lightguide is mounted on the front side of the
22. epidermis will be drained away by the by making contact with the cooled sapphire light guide 5 0 Fluence Fluence is a measure of the light energy delivered to the skin per unit area Fluence is measured as Joules per centimeter squared J cm Fluorescent light created by the OmniLight FPL passes through the lightguide and the coupling gel onto the patient s skin The greater the fluence is the higher the temperature of the targets in the skin the surrounding tissue and the epidermis The thin layer of gel acts as a thermal bridge between the skin surface and the externally cooled sapphire end face that effectively removes excessive heat from the epidermis By doing so the fluence can be raised safely when necessary with minimal or no adverse effects External cooling of the sapphire lightguide can be achieved by using the optional external cooler attachment the OmniCool system If the external cooler is not used the lightguide can be cooled by spraying it with cryogen or by immersing the lightguide in iced water American Medical Bio Care Inc Page 55 Copyright 2003 All rights reserved OmniLight FPL User s Manual 6 0 Recommended Parameters for Skin Rejuvenation Filter 480 515 535 580 nm for skin type I II 535 550 580 nm for skin type III IV 580 nm for skin type V Flashlamp 20mm nominal Power settings 15 J cm 45 J cm approx 20 80ms with SPF 20 J cm 70 J cm approx 60 250 ms wi
23. er areas are to be treated American Medical Bio Care Inc recommends that you mark the skin area in sectors of 6 x 6 cm 2 1 3 x 2 1 3 using a red marker pen Note it is enough to use dotted the lines Next apply the coupling gel to one sector at a time and treat 4 0 Pulse Width Choosing the correct pulse is essential for a successful treatment The time it takes for an object to cool is a function of that object s size Cooling time is shorter for small objects and longer for large objects The OmniLight FPL takes advantage of this thermal selectivity i e longer cooling time of a relatively large hair follicle and shorter cooling time of the thinner epidermis It does this by structuring each pulse as a series of small pulses with a delay or off time in between Ideally the delay should be long enough for the epidermis to cool down between the small pulses by losing its heat to the cooler gel and the cooled light guide But the delay should also be shorter than the cooling time of the follicle so that the follicle retains much of its heat and its temperature increases with each pulse For most patients a shorter pulse is suitable Dark skin absorbs more light and heats to a higher temperature thus longer pulses are necessary 5 0 Fluence Fluence is a measure of the light energy delivered to the skin per unit area Fluence is measured as Joules per centimeter squared J cm Fluorescent light created by t
24. es in the Power Cube No response when pressing Contact LUXSANO up down arrow Service department 6 7 Error Messages Code Message Action to be taken 17 Handpiece Open Turn off the main power switch and reattach the handpiece 23 Calibration Key Card Properly insert the Calibration Key Removed Card 19 Case Open Insure that the console is closed properly If this problem persists contact the LUXSANO Service department 32 Lamp not simmering Change lamp Contact the LUXSANO Service Department 20 Coolant Over Verify that the water reservoir is temperature full If problem persists contact the LUXSANO Service Department 18 No Flow of water Verify that the water reservoir is full Contact the LUXSANO Service Department American Medical Bio Care Inc Copyright 2003 All rights reserved Page 41 OmniLight FPL User s Manual 21 Discharge board over temperature Allow the cool down for 5 minutes Contact the LUXSANO Service Department American Medical Bio Care Inc Copyright 2003 All rights reserved Page 42 OmniLight FPL User s Manual Section 7 Accessories The OmniLight FPL Pulsed Light System accessories are Protective Eyewear Coupling Gel Replacement kit of consumables Lamp filters and CalCard Two spare fuses 7 1 Protective Eyewear Protective eyewear protects the eyes from the pulsed light emitted by the system The eyewear must be worn by all those pr
25. esent during a treatment with the OmniLight FPL Pulsed Light System The physician and other staff members should wear eyewear with optical density of 3 while the patients should wear the supplied metal eyewear cups 1 pair of each type is supplied with the unit 7 2 Coupling Gel A clear water based ultrasound gel is used for optical coupling The gel is available in 0 5 liter bottles 7 3 Replacement Lamps and Filters The consumable kit consists of 1 lamp filters and the CalCard 7 4 Optional Treatment Handpieces Optional handpieces are available Call AMBC at 949 477 5795 for further information American Medical Bio Care Inc Page 43 Copyright 2003 All rights reserved OmniLight FPL User s Manual Section 8 PHYSICIAN INFORMATION 8 1 Training Requirements The OmniLight FPL Pulsed Light system is designed to be operated only by properly trained personnel This may include physician nurses technical staff or other professional staff members In service training is provided by Luxsano or its distributors 8 2 Indications and Contra indications The OmniLight FPL Pulsed light system is indicated for Removal of unwanted hair in all skin types Permanent hair reduction Skin rejuvenation o Treatment of vascular lesions such as telangiectasia spider veins spider nevi port wine and rosacea and Achieving the desired result may take multiple treatments o Treatment of benign pigmented lesions o Collage
26. f immediately WARNINGS Pulsed light emission can present an eye hazard Use the appropriate protective eyewear anytime the equipment is being operated Using energy settings higher than those recommended during training or previously established as safe may cause thermal damage to the skin including hypertrophy and or atrophy and or abnormal pigmentation Always guard against accidental exposure to the pulsed light including light that is emitted directly from the handpiece or indirectly from a reflecting or scattering surface Never look directly into the light beam or the distal end of the sapphire lightguide even if you believe the unit is non operational Never point the handpiece so that it discharges into free space When not in use the handpiece should always be put back into the handpiece holder American Medical Bio Care Inc Page 12 Copyright 2003 All rights reserved Labeling Omnilight FPL Model P N S N 110 V 16 A 50 60Hz 220 V 8 A 50 60Hz US PATENT DANGER Fluorescent Pulsed Light Use proper eye protection wear when operating and or treating patients Never look directly into light the source Visible to near infrared light 500 1200 nm American Medical Bio Care Inc Copyright 2003 All rights reserved OmniLight FPL User s Manual CAUTION HIGH VOLTAGE HIGH CAPACITANCE Unit contains potentially LETHAL electrical charge Before working on the unit
27. handpiece The replaceable fluorescent filters are inserted between the sapphire lightguide and the body of the handpiece Pressing the trigger button on the handle activates the light pulse The light passes through the fluorescent filter and the spectrally corrected light passes through the sapphire lightguide and onto the treatment area 3 2 Software The software in the OmniLight FPL Pulsed Light System serves several purposes It allows the user to select optimal treatment parameters for each patient It controls the machine operation and prevents the safety hazards American Medical Bio Care Inc Page 18 Copyright 2003 All rights reserved OmniLight FPL User s Manual Jt checks and ensures energy calibration It verifies that the correct handpiece is in place It serves two counting functions One function counts the number pulses remaining on the filter and a second function counts the remaining number of pulses for the flash lamp 3 3 Specification Light Source Fluorescent enhanced Xenon flash lamps Spectral output Laser dye impregnated polymer filters cut on at 515 535 550 580 and 615 nm An internal water filter provides blocking of harmful IR radiation emitted above 1 000 nm Pulse Width 2 500 ms with standard or advanced pulse forming algorithms Hair Removal HR Handpiece Spot size 20 x 10 mm Fluence up to 70 J cm Est lamp life 10 000 pulses Fast hair Removal HR Handpiece optional
28. he OmniLight FPL passes through the lightguide and the coupling gel onto the patient s skin Contrary to many laser devices the fluence from the Omnilight FPL is constant over the treated spot due to the long wave guide in combination with a non coherent light source The greater the fluence is the higher the temperature of the target hair the surrounding tissue and the epidermis The pre cooled sapphire kept in skin contact will efficiently remove excessive heat generated by light absorption in the epidermal melanin By American Medical Bio Care Inc Page 5 0 Copyright 2003 All rights reserved OmniLight FPL User s Manual doing so the fluence can be raised safely when necessary with minimal or no adverse effects External cooling of the sapphire lightguide can be achieved by using highly recommended the optional external cooler attachment the OmniCool system If the external cooler is not used the lightguide can be cooled by spraying it with cryogen gas or by immersing the lightguide in iced water 6 0 Recommended Parameters for Hair Removal Filter 615 nm for dark brown hair skin type I V 580 nm for light thin skin type I IV Flashlamp 20 mm Power 20 35 J cm standard pulse forming 40 80 ms 30 65 J cm Advanced Pulse Forming 80 250 ms External Chiller Set to the lowest setting lt 5 C 7 0 Treatment Select the desired pulse width and fluence Place the protective eyewea
29. hould be for the safety of the patient the operator and other personnel When designing the OmniLight FPL Pulsed Light System considerable effort was made to maximize safety for the patient and the operator A self test of the electrical circuits takes place after the machine is turned on The test circuits continuously monitor the system operation during treatment Light is only emitted through the front plane of the headpiece s sapphire lightguide An interlock is placed in the handpiece interface that will not allow the system to function if the handpiece is attached improperly to the console Interlocks are present also inside the console to prevent the equipment from functioning if any of the console panels are removed American Medical Bio Care Inc Page 10 Copyright 2003 All rights reserved OmniLight FPL User s Manual Interlocks are present in the handpiece to prevent the system from functioning if the end caps are open WARNING Pulsed light emitting devices can cause injury if used improperly High voltage 10 kV is generated inside the OmniLight FPL Pulsed Light System Personnel who work with pulsed light systems should always be aware of the possible dangers and take the proper safeguards as described in this manual The Patient Patient safety is assured by a well trained staff and a well laid out treatment room Patient education is important including information about the treatment itse
30. itch and install the correct combination of CalCard and handpiece Then turn the machine back on The up down arrows on the front of the control panel are used to select between these options American Medical Bio Care Inc Page 29 Copyright 2003 All rights reserved OmniLight FPL User s Manual Once the desired settings have been selected there will be a short delay while the capacitors in the system are charged up and the flashlamp in the handpiece will be jump started with a high voltage pulse The sapphire lightguide on the handpiece will begin emitting a steady white light indicating that the lamp is simmering When the capacitors are fully charged a beep will sound indicating that the system is ready for use After each pull of the trigger the beep will indicate when the next output pulse can be emitted There is a built in function that controls the output timing of the flashlamp which requires a minimum of two 2 seconds delay between pulses 5 3 Treatment Switch on the cooler unit Set desired sapphire temperature see OmniCool user s manual for instructions Start up Omnilight unit to simmer mode Select appropriate fluorescent filter and insert it into the filter holder Choose desired pulse forming mode To be able to use the highest fluence range gt 45 J cm the APF Advanced Pulse Forming mode is the only option For lower range fluencies lt 35 J cm the SPF Standard Pulse Forming mode is
31. lf as well as the expected outcome of the treatment The patient shall wear the provided protective eyewear during treatment Personnel Operating the OmniLight FPL Exposure to fluorescent pulsed light requires eye protection that lowers the intensity of the light The operator and any other personnel present shall wear the provided protective eyewear during treatment Treatment Room The treatment room should be labeled with signs indicating that pulsed light is being used CAUTION Fluorescent Pulsed Light device may present eye hazard Use proper eye protection wear when in operation and or in treatment Visible and near infrared light American Medical Bio Care Inc Page 1 1 Copyright 2003 All rights reserved OmniLight FPL User s Manual 2 2 Cautions and Warnings CAUTIONS Technical service should only be performed by personnel authorized by Luxsano The OmniLight FPL Pulsed Light System must be wired correctly for the wall voltage used in your country Maintenance should only be performed when the unit is shut down and disconnected from power Performing maintenance procedures with the system powered up may be hazardous The lightguide must be kept clean at all times Gel and any other liquids used near the system should not be allowed to seep inside the handpiece If water is detected leaking from the handpiece the power should not be turned on If it is already on it should be turned of
32. n stimulation skin texture improvement Contraindications Pregnancy History of keloidal scarring Diabetes Active localized or systemic infections Compromised immune system Coagulation disorders Photosensitivity or allergy 8 3 Pre treatment preparation During the patient s first visit to the physician or to an authorized staff member if allowed by law Take a detailed patient history including previous treatment modalities and determine the suitability for treatment American Medical Bio Care Inc Page 44 Copyright 2003 All rights reserved OmniLight FPL User s Manual Determine why the patient is seeking treatment and understand his her expectations Discuss fluorescent pulsed light treatment with the patient Inform the patient of the following o There may be some discomfort associated with the treatment o Transient erythema edema may appear immediately following treatment o Achieving the desired result may take multiple treatments o There is a risk of adverse reaction including change in texture and pigmentation of the skin 8 4 Photography It is recommended to take photographs before and after each session to document the progress of the treatment Because many patients often are unable to objectively assess the progress of the treatment these photographs provide concrete evidence Standard conditions and similar speed flash and focal length should be used to enable an
33. ning gel should be cleaned from the treated area Never reuse gel Luxsano recommends the application of moisturizing lotion on the treated area twice a day for one week after each session 10 0 11 0 American Medical Bio Care Inc Immediate Normal Response After Treatment Appearance of erythema edema Slight skin erythema although not in the shape of the lightguide 2x1 cm A brownish tint in the gel Skin tightening Follow up The patient should return several weeks after treatment for examination of the treatment site If no additional treatment is necessary the patient should return for an additional re examination three to four weeks later If no change is noted the fluence for the next treatment should be increased Page 57 Copyright 2003 All rights reserved
34. ns that are mainly pigmentary use filters with longer wavelengths Smear a small amount of gel onto the selected skin area The gel acts as an optical and thermal coupler between the lightguide and the skin Cool the bare lightguide not the filter holder with cold spray or ice water for 3 4 seconds and hold the sapphire over the selected area The optional OmniCool Lightguide cooler will provide superior cooling Keep the sapphire in close contact with the skin and depress the trigger Apply one pulse to the selected patch and wait 15 minutes If no significant redness blisters or burns occur apply a slightly more powerful pulse to another patch area and so on If no reaction is detected after the second test patch start the treatment If a blister is formed after the weakest pulse test stop treatment and repeat the test patches with lower energy levels during another session after 1 2 weeks Ideally the patient should be asked to return after 5 7 days for evaluation and the first treatment 3 0 Preparation of the treatment area It is important to properly prepare the skin in the region to be treated Good preparation will enhance the treatment and ensure reliable results It is always a good idea to clean the skin and remove any possible specs of dirt or make up Such specs although small can cause part of the light to be focused into a small area of skin which may feel uncomfortable It is also important to sh
35. of the target point Selective heating of melanin American Medical Bio Care Inc Page 7 Copyright 2003 All rights reserved OmniLight FPL User s Manual Applying the same principle to the pigmented skin lesions and hair the melanin pigment has a wide but wavelength dependant absorption spectrum The light absorption in melanin is high at visible blue light 400 nm but descends as wavelength increases further up to approximately 900 nm Above this wavelength the melanin has insignificant absorption The optimal spectral range for treatment of unwanted hair and dark thick pigmented lesions is 600 900 nm while the band 515 600 nm is more effective on shallow and light pigmented lesions The spectral band 515 600 nm is not very useful in hair removal since the penetration depth is rather shallow due to strong competing hemoglobin absorption As pointed out above the red and infrared portion of the spectrum is ideal in hair removal since this spectrum penetrates deep enough to heat the follicle by heat conduction from the selectively heated hair shaft When the follicle s outer root sheath reaches 70 C the germinative cells denature leading to permanent destruction of the complete hair follicle structure inhibiting hair re growth 1 2 Unique FPL features The FPL provides superior clinical efficacy without compromising the safety aspects How is that possible The answer is the unique combination of user beneficial feat
36. ove fire 1 2 pulses immediately before replacement The filter will loosen from the sapphire surfaces due to heat expansion in the polymer American Medical Bio Care Inc Page 37 Copyright 2003 All rights reserved OmniLight FPL User s Manual 6 5 Filling and Changing the Cooling Water e CAUTION NEVER run the pump without water Doing so will cause irreparable damage The water filling tap is located on the back of the unit When filling Remove the fill cap Use the water filling bottle that came with the OmniLight FPL Fill with the de ionized water Fill with de ionized water up to the fill line in the slit window on the back Start the OmniLight FPL and fill with more water as the system replaces trapped air with water Add water until it reaches the fill mark in rear window indicating that the reservoir is full Connect drain fitting and tubing to drain port at bottom rear of the unit with fill cap on the reservoir following see picture below American Medical Bio Care Inc Page 38 Copyright 2003 All rights reserved OmniLight FPL User s Manual 6 6 Replacing the Handpiece e CAUTION Do not drop the handpiece when removing it from the console This could lead to damage to the handpiece and the sapphire lightguide American Medical Bio Care Inc Turn off the main power switch On Off switch Press in the three main latch buttons located on the handpiece whe
37. pecification and is properly calibrated Use of a device that has been resold but not inspected is a misuse of the device and may result in injuries All warranties express and implied will be void Copyright This publication or any part thereof may not be reproduced or transmitted in any form or mean electronic or mechanical including photocopying recording storage in any information retrieval system or other wise without the prior written permission of Luxsano American Medical Bio Care Inc Page 2 Copyright 2003 All rights reserved OmniLight FPL User s Manual Regulatory The OmniLight FPL Pulsed Light System is designed to meet international safety and performance standards CE Insert picture of ISO 9001 ISO13485 certification logo Personnel operating this device must have a thorough understanding of the proper operation of the system This manual has been prepared to aid medical and technical personnel to understand and operate the system Read this manual prior to operation of the system The contents of this manual are not intended to replace physician or professional training in the clinical use of the OmniLight FPL Pulsed Light System American Medical Bio Care Inc Page 3 Copyright 2003 All rights reserved OmniLight FPL User s Manual Note OmniLight is a trademark of Luxsano Introduction The OmniLight FPL Fluorescent Pulsed Light system is the latest advancement in pulsed light
38. r on the patient and the user Ensure that the lightguide is clean Ensure that the desired filter is in place Apply a thin 1 mm layer of coupling gel to the treatment site Place the lightguide perpendicular to the skin and apply firm pressure The lightguide should be in contact with the skin Excessive gel is pressed away from the contact area Trigger a test pulse Wipe off the gel and examine the treatment site The smell of burn hair or a brownish color in the gel may be detected If the skin shows no adverse effects from the test pulse reapply gel to the treatment site and proceed with the treatment Try not to overlap treatment sites by more than 1 mm American Medical Bio Care Inc Page 5 1 Copyright 2003 All rights reserved OmniLight FPL User s Manual Note American Medical Bio Care Inc recommends that the coupling gel only be applied to an area 6 x 6 cm This will prevent the gel from drying during the treatment 9 0 Post Treatment After finishing the session a cold towel or Aloe Vera gel is applied The patient is informed to avoid using any soap during the same day of treatment as well as direct prolonged sun exposure for at least 2 4 weeks after treatment Once the whole area has been treated the handpiece must be replaced in its cradle and the excess gel should be removed using a spatula or paper towels Any remaining gel should be cleaned from the treated area Do not reuse g
39. re it connects to the console While pressing the three latch buttons pull the handpiece hanger block slightly in a horizontal direction away from the console Press the two opposite water fitting latch buttons on the sides of the handpiece hanger with one hand and pull out the complete handpiece block from the main unit guidance pins Align the guidance pins with the corresponding holes on the new handpiece and snap it into place Page 39 Copyright 2003 All rights reserved OmniLight FPL User s Manual 1 Push and release the three latch buttons Pull HP holder out a few millimeter 2 Push and release the two opposite water fitting latches and ala 3 Pull out the HP unit from the main console 4 Put back the HP by aligning the three guiding pins on the interface with corresponding holes on the hanger interface and push it firmly in place Check that all three main latch knobs have snapped into to lock position American Medical Bio Care Inc Page 40 Copyright 2003 All rights reserved Troubleshooting OmniLight FPL User s Manual If one of the following problems appears follow the recommended action as listed below Problem Possible cause Action No Display Power disconnected Check Power Cable Plug cable into wall socket Check fuses in the Power Cube System does not start Calibration Card not in Check Calibration stalled properly Card Check fus
40. rge follicles are normally more difficult to treat since the associated follicle volume is larger and requires higher total energy fluence to be heated up to coagulation temperature A high fluency must always be delivered with pulse form duration that prevents melanin destructive overheating of the hair shaft and matrix If the melanin is overheated it will evaporate and lose it ability to absorb light If this occurs during the pulse the follicle heating may not be completed properly The effect would then be temporary hair regrowth may occur up 6 months after treatment reduction rather than permanent hair removal The OmniLight FPL only affects hair follicles that contain melanin rich hair shafts The degree of effectiveness often depends on the fluence used during the treatment 1 0 Preparation of the patient The patient should be informed about the hair growth cycle how the machine works how much it costs per session and how many sessions are expected The client should also be aware of the restrictions and possible risks and side effects Repeated sessions 3 6 treatments at 2 3 month intervals are necessary to achieve complete or nearly complete removal of unwanted hair in most patients with ideal skin and hair color Clinical studies have shown that most patients are satisfied after 3 7 treatments Obstinate cases may require more than 8 treatments American Medical Bio Care Inc Page 47 Copyright 2003 All rights reserved
41. s reserved OmniLight FPL User s Manual Section 4 Installation The OmniLight FPL Pulsed Light System is designed for easy installation and requires minimal site preparation Installation is carried out by AMBC authorized personnel Installation includes the following 4 1 Unpacking the OmniLight FPL and positioning it in the pre selected location Verifying the integrity of the unit and its components Plugging the system into the designated electrical outlet Testing the system for proper calibration and function of all operations Coordinating the performance at an on site inspection if required Fill DI water into the rear water reservoir see section 6 5 Filling and Changing the Coolant Water Omnilight Shipping Configuration The OmniLight FPL Pulsed Light is multi purpose instrument that can be delivered to end user in configurations dependant on customers needs 1 3 One OmniLight FPL Console assembly One Power Cube set to customers defined operating voltage One or more customer selected Handpiece s with lamp filters and handpiece specific CalCard One spare Lamp replacement kit with each handpiece A kit contains one lamp one CalCard fluorescent filters rubber finger tips and instructions One Optical Power Meter One OmniCool assembly with cooling liquid and manual The OmniCool is a required accessory and is not included in system price The customer may have his own cooler that can be us
42. t FPL User s Manual Section 1 System Overview e Caution This manual should be read thoroughly prior to Physician or other personnel operating or maintaining this equipment 1 1 Use Principle OmniLight is the latest modality for aesthetic skin treatment and the operation principle is based on the Selective and Extended theory of Photo Thermolysis The principle of skin rejuvenation and hair removal is selective heating of the unwanted skin lesion to various temperatures depending on the type of the lesion without any damage to the surrounding skin It operates through a creation of a directed incoherent light beam of spectrally balanced light A sapphire crystal light guide is used to transport the resultant longer wavelength light to laser dye impregnated polymer sheet which emits the selected wavelength band Incorporating all the benefits of both laser and Intense Pulse Light in a single system OmniLight offers non invasive safe and effective method for skin rejuvenation Selective Heating of Tissue by Photo Absorption The light emitted from the OmniLight is composed of a lesion optimized broad band spectrum of colors When the light hits an object the target chromophores e g melanin and hemoglobin absorb specific wavelength bands while the other structures in the object poorly absorb these wavelengths The absorbed light energy is transformed into heat energy results in selective destructive heating
43. technology It can be used for multiple applications including hair removal treatment of pigmented lesions and treatment of vascular lesions The intent of this manual is to provide the physician and technicians who operate the OmniLight FPL Pulsed Light System with information on the operating principles controls safety precautions installation and maintenance of the system Section 1 Overview Contains general information about the OmniLight FPL Pulsed Light System Section 2 Safety Features Contains explanation and direction concerning safety measures required for the OmniLight FPL Pulsed Light System Section 3 System Description Contains a complete description of the OmniLight FPL Pulsed Light System Section 4 Installation Explains requirements for the proper installation of the OmniLight FPL Pulsed Light System Section 5 Operation Explains how to safely operate the OmniLight FPL Pulsed Light System Section 6 Maintenance and Provides a review of how to maintain the Troubleshooting equipment as well as a troubleshooting guide Section 7 Accessories Describes all available accessories and ordering information Section 8 Treatment information Provides details on the treatment process as well as pre treatment care post treatment care indication and contraindications American Medical Bio Care Inc Page 4 Copyright 2003 All rights reserved OmniLight FPL User s Manual TA
44. th APF 7 0 Treatment Select the desired pulse width and fluence Place the protective eyewear on the patient and the user Ensure that the lightguide is clean Ensure that the desired filter is in place Apply a thin 1 mm layer of coupling gel to the treatment site Place the lightguide perpendicular to the skin and apply gentle pressure The lightguide should be in skin contact with very thin remaining gel layer Trigger a test pulse Wipe off the gel and examine the treatment site The smell of burnt hair or a brownish color in the gel may be detected If the skin shows no adverse effects from the test pulse reapply gel to the treatment site and proceed with the treatment Try not to overlap treatment sites by more than 1 mm Note Luxsano recommends that the coupling gel only be applied to an area 6 x 6 mm This will prevent the gel from becoming warm during the treatment American Medical Bio Care Inc Page 56 Copyright 2003 All rights reserved OmniLight FPL User s Manual 9 0 Post Treatment After finishing the session a cold towel or Aloe Vera gel is applied The patient should avoid using any soap during the same day of treatment as well as prolonged direct sun exposure for at least 2 4 weeks after treatment Once the whole area has been treated the handpiece must be replaced in its cradle and the excess gel should be removed using a spatula or paper towels Any remai
45. the recommended mode option American Medical Bio Care Inc Page 30 Copyright 2003 All rights reserved OmniLight FPL User s Manual Set the desired fluence and pulse width by pressing the up down arrow keys Check that the cooler has reached preset temperature range Prepare the skin area by smearing out a 1 mm thick gel layer When the desired parameters are selected the treatment can begin During the actual treatment it is highly recommended that you always wear dark green eye protection glasses While the glasses offer some degree of light filtration it can still be rather bright Some users find that closing their eyes in synchronization with the pulses reduces this discomfort WARNING The brightness of a flash may cause injury if the distance between the eye and the lightguide opening is less than 30 cm Never look directly into the lightguide Likewise the person being treated should always wear the non transparent metal eye shields enclosed with the unit Patient eye protection must be in place when the face is treated Although the handpiece is very light and ergonomic it is recommended that you hang the umbilical cord over your shoulders to relieve any stress to your wrist arm shoulder or back American Medical Bio Care Inc Page 3 1 Copyright 2003 All rights reserved OmniLight FPL User s Manual gt ra i oe ge Eye protection pieces for the user and patient
46. ugh the conductor in the power cable This grounding is essential to safe operation 2 4 Fire Hazards The absorption of light raises the temperature of the absorbing material Take precautions to reduce the risk of igniting combustible materials Do not use a flammable substance such as alcohol or acetone in preparation of the skin for treatment Only use soap and water If alcohol is used to clean and disinfect the system it must be allowed to dry completely before the system is used 2 5 Safety Features Calibration Key Card CalCard In order to operate the system the Calibration Key Card must be inserted into the slot located on the top of the unit The calibration key card allows the system to start up in operational mode This American Medical Bio Care Inc Page 14 Copyright 2003 All rights reserved OmniLight FPL User s Manual prevents unauthorized use of the unit Note Keep the CalCard in a safe place Lost card will not be replaced free of charge On Off Switch An On Off switch is located on the back of the unit at the top right hand corner Console Interlocks If the console on the unit is opened a series of interlocks shut down the power to the system to prevent accidental electrical shock Handpiece Interlock When the handpiece is removed an interlock shuts down the power to the system to prevent accidental electrical shock Lamp Interlock If the end caps on the handpiece have be
47. uld be relatively close to each other In Standard Pulse Forming mode typically one pulse with a selected duration 60 ms and different fluency e g 25J cm 25 J cm 35 J cm is applied to each of the test patch areas Always start with lower pulse durations and increase gradually In the Advanced Pulse Forming start with higher pulse duration e g 80 ms and higher fluencies such as 35 Jem 40 J cm etc Gradually raise the fluence in approximately 5 J cm intervals until the ideal fluence is found American Medical Bio Care Inc Page 48 Copyright 2003 All rights reserved OmniLight FPL User s Manual For darker skin skin type gt HI start with a pulse duration of 120 ms or more Smear a small amount of contact gel onto the selected skin area The gel acts as an optical and thermal coupler between the lightguide and the skin Cool the bare lightguide not the filter holder with cold spray or ice water for 3 4 seconds and hold the sapphire over the selected area The optional OmniCool Lightguide cooler may also be used Keep the sapphire in close contact with the skin and depress the trigger Apply one pulse to the selected patch and wait 15 minutes If no significant redness blisters or burns occur apply a slightly more powerful pulse to another patch area and so on If no reaction is detected after the second test patch start the treatment If a blister is formed after the weakest pulse test stop
48. ures built into the FPL device e Spectral power distribution control by utilization of patented fluorescent filter technology and lamp plasma current density control The fluorescent filters also provide clear cut blocking of harmful shorter wavelengths e Advanced temporal pulse power forming of light energy for optimal heat control of the complete tissue target volume e Skin contact cooling with the sapphire light guide Sapphire temperature is accurately controlled by an external cooler Cooling is confined exactly to the spot size providing consistent and repeatable clinical response e High fluence American Medical Bio Care Inc Page 8 Copyright 2003 All rights reserved OmniLight FPL User s Manual 1 3 System basics The OmniLight Pulsed Light System is a computer controlled system consisting of four major components System console power cube treatment handpiece and an external cooler The external cooler provides feed back temperature control of the sapphire waveguide range 5 to 25 C accuracy 1 5 C The user interface consists of an LED display having four push buttons to control input In running mode the LED shows sapphire temperature The user interface Control Panel consists of a flat panel with three membrane switch push buttons and a LCD display located on the top of the system console The panel displays the machine modes and parameters and is easily controlled with up and down arrows
49. ve them naturally and replace them with fresher healthy skin 1 0 Preparation of the patient The patient should be informed about how the machine works how much it costs per session and how many sessions are expected The patient should also be aware of the restrictions and possible risks and side effects Normally patients will require usually 3 5 treatments at 3 week intervals The number of treatments has been determined clinically as providing the maximum benefit while reducing side effects and complications to near zero 2 0 Test Patch It is recommended to spend the first visit with the patient imparting information and carrying out tests of 3 5 patches These patches should be relatively close to each other In Standard Pulse Forming mode typically one pulse with a selected duration 50 ms and different fluency e g 15J em 20J cm 25J cm is applied to each of the test patch areas Always start with lower fluencies and increase gradually In the Advanced Pulse Forming mode start with fluences of typically 20 J cm and a pulse duration of 60 ms Gradually raise the fluence in approximately 3 5 J cm intervals until the ideal fluence is found For darker skin types gt HI start with a pulse duration of 80 ms or more For conditions that are mainly American Medical Bio Care Inc Page 53 Copyright 2003 All rights reserved OmniLight FPL User s Manual vascular use filters with shorter wavelengths For conditio
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