Operator`s Manual - Beauty Light Technical IPL & RF
Contents
1. Ellipse Light Table of Contents Ellipse Light Operator s Manual The manual 1 2 1 3 1 3 Indications for use Note Fitzpatrick Standard Skin Type Definitions Successful treatments using Ellipse Light General Treatments Hair Removal Skin Rejuvenation Procedure Contraindications Chapter 2 TREATMENT SCENARIOS 2 1 2 2 2 3 2 4 2 5 2 6 2 7 2 8 General Logging on Choice of treatment screens Treatment of a patient Hair treatment Treatment of a patient Skin rejuvenation Menu items overview Shutdown System Menu Chapter 3 MAINTENANCE 3 1 3 2 3 3 3 4 Changing applicators Filling and draining the water supply Filling the System Draining the System System disinfection Applicator Disinfection Cabinet Cleaning Technical requirements 1MANO132 ENG E08 aa eb oe oe os 1 i i ONaARWDN ya ola WL ea NNO 2 4 2 6 2 7 2 7 3 1 3 1 3 2 3 2 3 2 3 4 3 4 3 4 3 4 Ellipse Light Table of Contents Chapter 4 SAFETY 4 1 4 1 Introduction 4 1 Restrictions On Use 4 1 4 2 Hazards 4 1 Eye Protection 4 2 Other Patient Related Hazards 4 2 Operator Related Hazards 4 3 Fire Hazards 4 3 General Precautions 4 4 4 3 System safety labeling 4 4 4 4 CE Conformity 4 5 4 5 IEC Symbols used 4 5 Chapter 5 TECHNICAL SPECIFICATIONS 5 1 Page ii 1MANO132 ENG E08 Ellipse Light Chapter 1 Chapter 1 ABOUT THIS MANUAL 1 1 The Manual The Operator s M2. message being displayed In this occasion the message can be ignored When water ceases to flow out remove the tubing from the applicator cooling water output and discard the excess in the container Because of the risk of impurities in the container the water must not be re used Ellipse Light Chapter 3 3 3 System Disinfection Applicator Disinfection It is essential that any areas that come into direct contact with the patient should be regularly inspected cleaned and disinfected Light guide housing Light guide Fig 19 Position of Light Guide and Housing This applies particularly to the light guide and the applicator Between patients the light guide and the light guide housing should be wiped with a mild soap solvent followed by disinfection using a non flammable disinfectant for example peracetic acid that is capable of killing bacteria fungal spores and viruses At least daily visually inspect the applicator for any signs of damage Once a week all applicator surfaces should be disinfected Cabinet Cleaning Cleanliness is a prime rule in maintaining equipment At least once a month external metallic surfaces should be wiped to remove any foreign material that may have accumulated Painted and plastic surfaces should be cleaned using a clean cloth moistened with a solution of soap and water Clean the display using a clean cloth dampened with a mild window cleaning solution Ensure that the cloth is not too w
3. but not too prominent Judge both the skin reaction and the patient s response discomfort level The time that should be allowed for skin reaction depends on the Skin Type of the patient Types 1 3 will usually react within a couple of minutes but for darker clients skin type 4 5 it is advisable to wait at least 15 minutes before proceeding with the actual treatment Based on the reaction and response it must now be decided if the suggested setting is safe and appropriate If you have to adjust the Current Energy this is done by clicking the up down buttons or 4 and pressing lt Accept gt When the treatment is done terminate the treatment by pressing lt Done gt Remember you can get on screen help by pressing the setting Skin Type Pigmentation Hair Thickness Current Energy concerned If you change the Current Energy setting from the default the blue field turns to grey If you want to re select the Standard Current Energy then press lt Standard gt Note for hair treatment the default Current Energy is quite conservative mild and better results may be achieved by increasing the Energy slightly This is because quite a wide Therapeutic Window exists Only adjust the settings after a test shot has been taken Any adjustment should be governed by the skin reaction and patient response 2 5 Treatment of a Patient Skin Rejuvenation To treat a patient follow the below given step by step guide Remember to check
4. eyes Medium to olive skin Moderate burns Usually tans Dark hair Dark eyes Burns mildly Dark olive to light brown Moderate browning skin Dark hair Dark eyes Brown skin Seldom burns Dark brown Dark hair Does not burn Dark eyes Insensitive Very dark skin does not burn Comments on Skin Type Often have freckles Should be the first consid eration in typing the aver age light skin other than obvious skin type 1 The light burning or pinking exposure to sun will pigment to a tan effect by evening Usually do not recognize that they burn moderately if exposure is moderate Will comment that they Can get a good tan with care Usually consider they tan easily and with moderate exposure in northern climates will not experience a burn very often Will burn if visiting higher intensity locations Seldom experiences a burn Burning will usually occur after having no previous exposure for months and then being exposed to very high intensity levels 100 on the SUNSOR scale Individuals have very high pigmentation that affords exceptional protection in ultraviolet light Ellipse Light Chapter 1 1 3 Successful Treatments using Ellipse Light General Treatments General Pre treatment care Before treatment always Remove patient s make up to avoid skin burns Ensure there are no tattoos or permanent make up in the treatment area These must not be treated as the pigment
5. not remove any covers ACAUTION Do not lean anything against the equipment Doing so could cause equipment damage Fire Hazards Ellipse Light emits high energy light flashes that when absorbed in any material can cause a dramatic increase of temperature or even cause the material to catch fire To prevent this take the following precautions AWARNING Never expose flammable material to the radiation emitted from the Ellipse Light AWWARNING Cleaning Never use flammable liquid like alcohol to clean or disinfect any part of Ellipse Light DDD recommends cleaning the applicator with a mild soap solvent followed by disinfection using a mild non flammable disinfectant see Section 3 3 System Disinfection AWARNING Equipment not suitable for use in the presence of flammable mixtures Ellipse Light Chapter 4 General Precautions ACAUTION Do not attempt to operate the Ellipse Light System without the applicator connected ACAUTION Air bubbles trapped in the applicator must be removed before releasing the first shot if not the applicator may stop working after a few shots ACAUTION Always reposition the applicator in the holder on the front of the cabinet when not in use AWARNING Always press lt Done gt before replacing the applicator AWARNING Do not attempt to use the Ellipse Light System if a safety problem is Known to exist AWARNING Do not attempt to use the Ellipse Light System if an applicator is leaking cool
6. that the VL 2 applicator REF 9APP7134 is connected before starting treatment Follow the Pre Treatment procedure listed in the Clinical Work Book This is also available as on screen help by pressing the top blue bar next to the clock To keep track on the number of shots for this specific treatment press lt Reset Counter gt before starting the treatment Enter the correct Skin Type of the patient to be treated by clicking the up down buttons v or A Enter the correct degree of skin Pigmentation of the area to be treated by clicking the up down buttons V or A The default Current Energy setting is automatically calculated This is based on the skin type and pigmentation you Nave selected Ellipse Light Chapter 2 Skin Rejuvenation Patient Parameters Skin Type Pigmentation rN a v v Treatment Current Energy J cm2 Counter ee Menu Reset Counter Push Accept to charge You must check that the Energy setting is safe and appropriate Validate the data you have entered and press lt Accept gt Start treatment when the system displays Ready in the status field at the bottom of the screen Use a test shot in an area relevant to the treatment area but not too prominent Judge both the patient s immediate response discomfort level and the skin reaction after 2 minutes The correct skin reaction is that the pigmented spots should darken If the skin turns a greyish colour
7. the energy setting is too high and will result in a skin burn after 1 5 hours Based on the reaction and response it Must now be decided if the suggested setting is safe and appropriate If you have to adjust the Current Energy this is done by clicking the up down buttons or 4 and pressing lt Accept gt When the treatment is done terminate the treatment by pressing lt Done gt Remember you can get on screen help by pressing the setting Skin Type Pigmentation Current Energy concerned If you change the Current Energy setting from the default the blue field turns to grey If you want to re select the Standard Current Energy then press lt Standard gt Note for Skin Rejuvenation the default Current Energy is very close to the optimum Energy This is because the Therapeutic Window is very narrow Only adjust the settings after a test shot has been taken Any adjustment should be governed by the skin reaction and patient response and if it is necessary to increase the Energy only increase it by the minimum Then take a new test shot and observe the patient s immediate response and the skin reaction after 2 minutes again Ellipse Light Chapter 2 2 6 Changing an Applicator before or during treatment It may be necessary to switch applicators before or during treatment for exam ple if treating a small area with the HR S Applicator The mechanism of the change is discussed in Section 3 1 When the new applicator is phy
8. treated with caution Skin Types 5 and 6 should not be treated Special for Skin Rejuvenation treatment ACAUTION Closely examine thae pigmented lesions and vessels ensuring that all are benign If in doubt the patient should be referred to a spcialist for further examination including the possibility of a biopsy Skin Rejuvenation Post treatment Care Patient should expect 1 2 treatment sessions before clearance of all lesions The final result and the number of treatments depend on a number of factors e g pigmentation position dermal or epidermal and colour of the lesion previous treatments pre treatment care Ellipse Light Chapter 1 Contraindications It is not possible for this document to give a future proof set of contraindications The rate of production of new drugs medications means that new information on drugs and combinations of drugs appears daily Most countries have an up to date register of drugs and their side effects including photosensitivity If in doubt the user should seek expert medical opinion from those with the ability to research the effects of disease and genetic conditions and further to research the side effects of medication Such information can also be obtained by emailing clinical 3d dk Currently Known contraindications are Patients with any disease or genetic condition causing photosensitivity Patients undergoing treatment with anticoagulants anti clotting drugs or any medica
9. wavelengths is enough to reach even the deeper hair follicles Small areas of hair can be treated with the HR S applicator REF 99APP7116 This uses the same wavelengths as above but has a diameter of 8mm Because of the size the maximum possible energy is capped at 16 5J cm2 For dark skinned patients the Ellipse HR D Applicator REF 9APP7114 emits light with wavelength 645 nm 950 nm This enables safe treatments in patients with a higher skin Concentration of melanin The penetration depth of these wavelengths is again enough to reach the deeper hair follicles Pulse Duration is dependant on hair thickness The Ellipse Light system automatically selects the appropriate pulse duration when the operator states the thickness of the hair Thin hair needs less energy to heat up and a relatively low level of energy is used Thick hair needs more energy to heat up and a higher energy level is used In general the highest energy levels should only be used in connection with longer pulse durations Ellipse Light Chapter 1 Hair pre treatment care In the 30 days before treatment do not Pull out the hair with tweezers wax or use depilatory creams nor bleach the hair Sunbathe or use solaria Hair treatment Mark the treatment borders with a RED pen Do not use other colours as they will absorb the light and cause skin burns Remember to shave the treatment area and remove all shaved hairs Press the applicator firmly against the ski
10. ACAUTION Certain hazards are associated with the application of intense light energy to the skin For this reason it is important that Ellipse Light is used only by suitably trained personnel who understand both the clinical applications and the dynamics of light tissue interaction Proper evaluation of both patient skin type and pigmentation is of paramount importance for efficient operation it is therefore vital that a thorough dermatological examination is carried out prior to any treatment Dark skin whether natural or due to sun tan will increase the risk of side effects Such as burns and will also reduce the efficiency of the treatment Be aware that pigmentation may vary over the treatment area and that absorption will be affected by pigmented nevi or tattoos Ellipse Light Chapter 4 Eye Protection AWARNING Ellipse Light emits high energy broad spectrum light flashes that could cause severe eye damage During treatment the patient and operator must wear protective eyewear of the type recommended below Eyewear Type Cutoff Marked Wavelength colour Provides Patient Goggles complete 2EYEO801 optical protection 615 720 nm Eye Protection OD factor gt 3 Green 2EYEO800 Operator Hair Removal 600 615nm OD faktor gt 2 Eye Protection 530 710 nm Skin Rejuvenation OD1 5 Blue 2EYE7002 ACAUTION Never trigger the flash lamp without warning all personnel present ACAUTION Never leave a patient unattended if the system is in
11. Hair Removal Thick Hair Skin Rejuvenation Photo Pigmentation Rejuvenation Diffuse Redness and Skin Texture Note Patients with darker Fitzpatrick Skin Types 4 or above or who are suntanned should always be treated with extra care and attention Key X Allowed Not Allowed AWARNING Ellipse Light has built in parameters to prevent treatment to patients whose skin type or level of pigmentation exceeds the maximum allowed Never try to treat patients above these limits treatment will be ineffective and will possibly result in a skin burn Note Fitzpatrick Standard Skin Type Definitions Ellipse Light Chapter 1 The table below gives a general description of the six skin types categorized by dermatologist Thomas B Fitzpatrick Other combinations of hair eye and skin colours can occur in each skin type ACAUTION Take care if treating dark skin with high energy settings Darker skin contains more light absorbing melanin Under treatment absorption heats up the skin and gives a higher risk of epidermal burns This should always be taken into account when treating Ssun tanned patients or those with a Fitzpatrick skin type of 4 or higher Ski Skin Reaction on Type Typical Skin Type Definition overexposure to UV light Red blond hair Blue green eyes Very light skin Always burns Never tans Light to medium hair Light to medium eyes Light to medium skin Usually burns Seldom tans Medium hair Medium to dark
12. absorbs part of the light energy and this can lead to a skin burn Shave the treatment area if required and remove the shaved hairs from the skin Apply optical coupling gel See Section 5 Technical specifications Use eye protection both operator and patient See Section 4 2 1 Eye Protection General Treatment Notes Identify the skin type according to the Fitzpatrick skin type scale Accurately enter this onto Ellipse Light which will adjust the default energy setting according to the skin type and pigmentation selected Identify the degree of pigmentation Suntan If necessary compare the treatment site pigmentation with an area not exposed to the sun Do not try to treat patients with a combination of skin type and pigmentation outside the indication of use See Section 1 1lndications for Use Default settings are placed in the lower end of the therapeutic window This is the area within a treatment where there is a notable beneficial effect with low risk of side effects To optimize the results the energy setting J cm can be increased to the upper part of the therapeutic window This is found based on the user s clinical knowledge by judging the skin reaction and the patient s tolerance of pain Use sufficient gel on the treatment area Place the Light Guide perpendicular to the skin surface to ensure maximum light penetration Always perform a test shot based on the recommended settings Observe both patient disco
13. anual is designed to provide you with the information needed to use the Ellipse Light System referred to below as Ellipse Light safely and effectively The Manual is divided into five sections Section 1 explains the intended use of Ellipse Light gives background information and outlines contraindications Section 2 explains the day to day operation of Ellipse Light including Treatment Scenarios Section 3 covers System Maintenance and Hygiene Section 4 covers System Safety Section 5 supplies Technical Specifications of the System and Applicators Throughout the document cross references to other sections of the Operator s Manual will be shown in the form see Section X Y Section Name References to other documentation produced by Danish Dermatologic Development for the Ellipse Light will be in bold text in the form Clinical Work Book The instruction to press a specific button will be given as in the example press lt Exit gt Note Ellipse Light uses a touch sensitive screen instead of a keyboard To press a button simply press the screen where the button is located This manual offers a brief hands on guide to use A more detailed explanation of Ellipse Light will be found in Operator s Reference Manual or Clinical Workbook The Operator s Manual will use the international symbols ACAUTION or BWARNING to denote a possible safety risk if instructions are not carried out correctly ACAUTION Caution is used to iden
14. ast digit entered If you press lt Shutdown gt button the system will shut down When the access code has been accepted you will be allowed access to one of the treatment screens 2 3 Choice of Treatment Screens Users are offered a choice of treatment screens dependent on the Applications used Hair Removal HR applicator REF 9APP7133 Hair Removal S Small areas using HR S Applicator REF 9APP7116 Hair Removal D for Dark Skin using HR D Applicator REF 9APP7114 and Skin Rejuvenation VL 2 Applicator REF 9APP7134 Ellipse Light chooses the correct treatment screen based on the applicator Hand Piece used Note that if you change applicators when Ellipse Light is shut down the system will detect the change when you start the System again and ask you to confirm the treatment you wish to perform See Section 3 1 Changing Applicators 2 4 Treatment of a Patient Hair Treatment F Hair Removal HR Patient Parameters Skin Type Pigmentation Hair Thickness Treatment Current Energy J cm Counter a Standard 12 0 12 0 0 v Accept Reset Counter Push Accept to charge To treat a patient follow the below given step by step guide Remember to check that the correct applicator hand piece is connected before starting treatment Follow the Pre Treatment procedure listed in the Clinical Work Book This is also available as on screen help by pressing lt Menu gt then lt Help gt and lt T
15. e used consult your DDD representative For long time storing or if the temperature will drop below 5 Celsius the cooling system must be drained of fluid See Section 3 2 Ellipse Light Chapter 4 Chapter 4 SAFETY 4 1 Introduction This chapter contains important information concerning potential hazards and general safety precautions The purpose of the safety instructions is to draw attention to potential hazards if instructions are ignored These hazards may lead to accidents or serious injury to the patient operator or service personnel Ellipse Light incorporates many safety features to protect the patient and the operator However as with all medical devices safe use of Ellipse Light relies on a safe attitude from a suitably trained Operator Do not use the system if a malfunction of the equipment or a safety problem is believed to exist Restrictions On Use ACAUTION This equipment is intended to be use by qualified personnel only and only after they have been trained to use the equipment Do NOT attempt to run or install any software other than that provided by DDD on the built in computer system WWARNING Using controls or adjustments or performing procedures other than those specified in this manual may result in severe personal injury or equipment damage AWARNING Injury to patient due to unintended flash release Do not leave the equipment in a condition ready to flash at any time Hazards
16. ed Access Code Ellipse Light Chapter 2 Change Applicator Change Applicator Photo rejuvenation applicator Last Changed 08 03 02 Shots This Applicator 33834 Continue Cancel insert Applicator Floppy and Press Continue Important Note The System Menu item lt Change Applicator gt is used to notify the system that you are changing a damaged applicator nhand piece with a new one It is not used for switching between Hair and Skin Rejuvenation applicators when performing different treatments More information including how to switch between Hair and Skin Rejuvenation Applicators is given in Section 3 1 Changing Applicators Update Software As new treatments develop these can be introduced by choosing the System Menu item lt Update Software gt Select lt Update Software gt insert the disk s containing the update and follow the on screen instructions Press lt Cancel gt to return to the previous treatment screen 1MANO132 ENG E08 Page 2 9 Ellipse Light Chapter 2 Page 2 10 1MANO132 ENG E08 Ellipse Light Chapter 3 Chapter 3 MAINTENANCE 3 1 Changing Applicators The procedure for changing the applicator is as follows Note if you are changing the applicator for refurbishment or repair you should follow steps 1 5 If you are simply changing from hair to skin rejuvenation or skin rejuvenation to hair you should follow steps 3 5 only AWARNING To prevent the risks of light d
17. et aS no excess moisture should be allowed to run into the cabinet 3 4 Technical Requirements Maintenance DDD or a DDD representative should perform all system maintenance The following maintenance intervals are recommended Every 6 months if powered more than 20 hours per week Every 12 months if powered less than 20 hours per week Local conditions and dusty environment may shorten the intervals Applicator lifetime may be reduced by lack of maintenance or lack or water 1MANO132 ENG E08 Page 3 3 Ellipse Light Chapter 3 Temperature If the temperature in a clinic using Ellipse Light drops below freezing point damage can be caused to the cooling system To prevent this keep Ellipse Light in a room above 5 Celsius or drain the cooling system of fluid See Section 3 2 Note the working temperature should be 15 30 C Storage Cabinet and Applicator If the Ellipse Light need to be stored a number of precautions need to be taken in order not to damage the equipment For long time storing more than 6 month the shipping box can be used if it is available if not consult your DDD representative The shipping box can be stored standing or lying on the pallet Storing Precautions The storage temperature must be within 5 40 Celsius 20 80 non condensing Protect the cabinet using a plastic cover Remove the applicator from the cabinet and store it separately For long time storing the shipping box can b
18. etailed instructions before proceeding Ellipse Light Chapter 5 Chapter 5 TECHNICAL SPECIFICATIONS GENERAL SPECIFICATIONS Dimensions dx wxh Weight Noise Max Electrical input Working Temperature Relative Humidity OUTPUT Light Source Pulse Duration Thin Hair Pulse Duration Medium Hair Pulse Duration Thick Hair Pulse Duration Skin Rejuvenation Charge Time Min Max ACCESSORIES 700 mm x 518 mm x 1110 mm 107 kg 55 dBA 105 125 10 VAC 15A 210 250 10 VAC 7 5A 15 30 C 10 75 Intense Pulsed Light I2PL 15 ms 20 ms 40 ms 2x 2 5 ms delay 10 ms 1 5 3 8 sec Optical Coupling Gel REF 2GELO826 250g or 2GEL1342 5kg APPLICATORS Weight excl Cable Hair Applicator HR Wavelength Output Max Foot Print Spot Size Dark Skin Hair Applicator HR D Wavelength Output Max Foot Print Spot Size Hair Applicator Small HR S Wavelength Output Max Foot Print Spot Size Skin Rejuvenation Applicator VL 2 Wavelength Output Max Foot Print Spot Size 500 g REF 9APP7133 600 950 nm 21 J cm2 10 mm x 48 mm REF 9APP7114 645 950 nm 18 J cm2 10 mm x 48 mm REF 9APP7116 600 950 nm 16 5 J cm2 8mm REF 9APP7134 555 950 nm 12 J cm2 10 mm x 48 mm Danish Dermatologic Development A S Agern All 11 DK 2970 H rsholm Denmark Tel 45 45 76 88 08 Fax 45 45 76 88 89 E mail clinical 3d dk ww
19. he Ellipse Light by pressing the symbol O at the rear of the cabinet 2 8 System Menu System Menu items are accessed by pressing Menu and System and then selecting the appropriate item The items are explained below Number of Applicator Shots This shows the total number of shots that have been performed with the applicator type Number of Applicator Shots aaa i Service Self Test 1MANO132 ENG E08 Page 2 7 Ellipse Light Chapter 2 Service The Service Menu requires a special access code It is used only when installing or servicing the Ellipse Light Language This is normally set up at the time of installation However pressing lt Language gt allows you to change the language used by Ellipse Light BES DEE Enter Current Access Code Change Code Ellipse Light is supplied with a default access code 1234 This can be changed by selecting lt Change Code gt You first need to enter the current access code by pressing the screen over the numbers When you have entered four numbers the status line at the bottom of the screen will ask you to enter the new code Again you need to enter 4 digits Finally you will be asked to repeat the new access code as confirmation Enter the 4 digits again and press lt OK gt to confirm the change You can cancel the operation by pressing lt Cancel gt at any time before finally pressing lt OK gt Always ensure that you have written down any revis
20. ing the Water Supply ACAUTION Only distilled or demineralised water should be used to fill Ellipse Light Ensure that no applicator is connected to the System and that you have selected lt Menu gt and lt System gt Filling the System Attach the water tubing to the applicator cooling water input This is labeled Place an excess water cup under the cabinet to collect excess water Fig 2 Lift the funnel and pour water into it Fig 3 until excess water begins to run into the drip tray When 1 dl 100cc water has flowed out carefully remove the tubing from the applicator cooling water input and discard the excess in the cup Do not run the Self Test on a drained system Note also that it is not necessary to have the Ellipse Light switched on when adding water Draining the System ACAUTION Ensure that no applicator is connected to the System and that you have selected lt Menu gt and lt System gt Place an empty 2 litre container on the floor near the system to collect excess water Attach one end of the water tubing to the applicator cooling water outlet This is labeled G gt Hold the other end of the tube in the container Press lt Self Test gt The pump operates when the Self Test is running It may be necessary to repeat the Self Test if you start with a completely full system The end point is when water ceases to flow out When draining the system it is likely that the Self Test will result in an error
21. ing water AWARNING AI areas that come into direct contact with the patients should be regularly cleaned and disinfected This applies particularly to the light guide and the applicator see Section 3 3 System Disinfection AWARNING mproper cleaning may result in equipment damage This applies particularly to the light guide see Section 3 3 System Disinfection 4 3 System Safety Labeling A Warning against Powerful Loght radiation from the applicator Avoid directly eye exposure See accompanying documents A Warning that a DANGEROUS VOLTAGE may be present S Applicator connection point Applicator cooling water output Applicator cooling water input Ellipse Light Chapter 4 4 4 CE Conformity Ellipse Light conforms with the requirements of council CE directive 93 42 EEC concerning medical devices and therefore bears the CE mark of Conformity Safety Classification The Ellipse Light has the following classifications Class llb according to Directive 93 42 EEC concerning medical devices Class I Type B according to EN 60601 1 safety standard This equipment requires a reliable protective earth Connection 4 5 IEC Symbols Used E gt Denotes Protective Earth Point x Alternating Current l ON Power O Off Power This symbol signifies Input Voltages 05 125 VAC amp 210 250 VAC Input Frequency 0 60H i Input Power A Type B Equipment gaal Manufacturer A Attention Consult accompanying documents for d
22. ips amp Tricks gt To keep track on the number of shots for this specific treatment press Reset Counter before starting the treatment Ellipse Light Chapter 2 Enter the correct skin type of the patient to be treated by clicking the up down buttons V or A Enter the correct degree of skin pigmentation of the area to be treated by clicking the up down buttons or A Enter the correct thickness of the hairs to be treated by clicking the up down buttons V or A The default Current Energy setting is automatically calculated This is based on the skin type pigmentation and hair type you have selectet Hair Removal HR D Medium Use of the various applicators is identical They are chosen according to the patient Skin Type and Pigmentation combination Note that the default energies and maximum energies vary according to the applicator in use Hair Removal HR S 3 E Medium sd Medium A EJ Ea Ea 12 0 ES ee If you are treating a small area of hair in the nose ears or between eyebrows use of the HR S Applicator is recommended 1MANO132 ENG E08 Page 2 3 Ellipse Light Chapter 2 FOR ALL HAIR TREATMENT You must check that the Energy setting is safe and appropriate Validate the data you have entered and press lt Accept gt Start treatment when the system displays Ready in the status field at the bottom of the screen Use a test shot in an area relevant to the treatment area
23. ischarge ensure that any treatment is concluded by Pressing lt Done gt on the treatment screen before changing the applicator 1 For Refurbishment Repair Only Press lt Menu gt then lt System gt then Change Applicator gt 2 For Refurbishment Repair Only Insert the floppy disk into the drive and choose lt Continue gt Data will be written onto the floppy disk Press lt Close gt when prompted to do so on screen Remove the disk Write the Serial Number of the old Applicator on the floppy disk and pack both together for shipping 3 Physically release the cable relief at the back of the cabinet Unplug the electrical connector and the two cooling water fittings A few drops of cooling water may leak from the fittings before the shut valve activates 4 Remove the old applicator and introduce the new by reconnecting the two cooling water fittings and the electrical connector Reposition the cable relief Make sure the water tubes are not kinked It might be necessary to turn the cable relief ACAUTION Always reposition the cable relief after replacing the applicator in order to avoid damage to the applicator cable and connectors Note that you should follow the agreed return procedure if shipping an applicator for refurbishment repair Release the cable relief Electrical Connection Reposition the cable relief Water Connections APPLICATOR CONNECTIONS Ellipse Light Chapter 3 3 2 Filling and Drain
24. luation has been carried out Ellipse Light Chapter 4 ACAUTION Dark skinned patients should only be treated with extreme caution Take a sample shot and evaluate reactions to this before continuing AWARNING When doing hair removal over tattooed regions including perma nent make up the tattoo may be partly removed or discoloured or epidermal adverse effects may be noted Operator Related Hazards Severe injury to the operator could be caused by incorrect use of the equipment Please ensure that the following precautions are observed WWARNING Do not use a power cable other than that supplied with the system The system must be connected to a 3 pin power point i e a socket with protective earth Contact a local electrician as necessary AWARNING Only power the Ellipse Light system as specified on the rear of the cabinet If the voltage specified does not correspond with that of the local supply please contact your DDD representative who will be able to rectify the problem AWARNING Never use the Ellipse Light System if the System is wet or appears to be leaking water ACAUTION Do not place coffee cups or other liquid containers on the Ellipse Light Spillage may damage the system and lead to malfunction AWWARNING Ellipse Light has covers to protect operators from electrical shock and mechanical hazards Always contact qualified service personnel for your servicing needs Do not attempt to service the equipment yourself and do
25. mfort and skin reaction erythema redness The test shot should be relevant to the treatment site but should not be prominent Do not slide the applicator across the treatment site lift it and place it down again This avoids a build up of optical coupling gel on the side of the applicator and reduces the risk of side effects If you need to shoot the same area again maybe using a higher energy allow the skin to cool for at least at least 1 minute between shots Ellipse Light Chapter 1 General Post treatment Care After the final shot remove the gel and dry the skin surface with a soft cloth A cool pack placed against the skin may be comforting for the patient Do not expose the treated area to sunlight or solaria for 1 month after treatment Use a sun block minimum SPF 60 SPF 30 if hair removal when exposure to sunlight is inevitable Hair Removal Target Chromophore Melanin The target is melanin in the hair and hair bulb These are heated to ensure conduction of heat to the hair follicle Only hairs in the growing phase can be treated therefore multiple treatments are necessary Good results can always be achieved if treating dark hair on a fair skin Treatment of blond light red or grey hairs is not effective because they have a lower melanin content Wavelength The Ellipse HR applicator REF 9APP7133 emits light with wavelength 600 nm 950 nm This gives high absorption in melanin The penetration depth of these
26. n surface This increases the efficacy due to Reduction of the distance between skin surface and hair Squeezing blood out of the superficial blood vessels This will reduce the absorption of light by the haemoglobins The energy can be increased until follicular or general erythema redness is observed or until the level of patient discomfort is reached AXCAUTION Note that in darker skin types 4 or 5 erythema may take from a few minutes to a few hours to develop Therefore you should always make a test shot well in advance of starting treatment Synchronisation of the Hair Grow Cycle The effect of a low energy setting can be to synchronise all hairs in the resting phases to an early anagen phase ThiS means more hairs are seen after the treatment which might be a disappointment for a patient who is not informed of the possibility The next treatment however will be even more efficient as more hairs are in the early growth phase Intervals between hair treatments The interval depends on the anatomic site treated as well as the individual patient It is recommended to perform the next treatment when re growth can be observed in the treated area Special for hair treatment The desired treatment effect is slight redness or swelling centred around the hair although this is not always seen Note that treatment of a skin type 6 patient or a skin type 5 with light pigmentation requires the HRD Applicator Ellipse Light Chap
27. ngs near the buttons Note that most of these are displayed as but if the Current Energy setting chosen is not the same value as the system default it will be a grey not a blue box You can also get help by pressing lt MENU gt and then lt HELP gt 2 2 Logging On The Ellipse Light is powered up using the switch at the rear of the cabinet Press the on switch symbol I to power up and the off switch Symbol O to turn off the power supply Refer to section 2 7 Shutdown An applicator needs to be connected to the Ellipse Light on power up The system will initially carry out a self test to confirm the applicator is in place and that the system is working correctly If the test reveals any irregularity it will advise the appropriate action to take You will not be able to treat a patient until the self test is passed If you need to change applicators follow the procedure shown in Section 3 1 Changing Applicators Enter Access code Ellipse Light Chapter 2 After the self test has completed you must enter the four digit access code by clicking the O 9 buttons The default access code is 1234 This can be changed see Section 2 8 4 Change Code When a four digit access code has been entered the Shutdown button will change to read OK The operator can then enter the system by pressing lt OK gt If you want to clear the access code you have entered press lt Clear gt or press lt amp gt to clear the l
28. sically connected you will see a message asking you to confirm the change Simply press the screen to confirm the applicator you have selected Please confirm the type of applicator connected to the system Menu Items Overview To access menu items press the button marked lt Menu gt that is found in the bottom left corner of the treatment screen You will see the following image Software version This is not important for normal day to day treatments but will be needed if you have to speak to DDD or our distributor on service or related issues System Pressing lt System gt will take you to the System Menu which deals with i Service Self Test System Language Changing the Access Code Changing Replacing the Applicator Updating the Software These items are dealt with in Section 2 8 System Menu Page 2 6 1MANO132 ENG E08 Ellipse Light Chapter 2 Help Press lt Help gt to provide you with a choice of all the help files that are available for Ellipse Light Cancel Press lt Cancel gt to return to the previous treatment screen Software version 7DERO061 H13 26Feb04 2 7 Shutdown To close down the system select lt Menu gt and then press lt Shutdown gt Select lt OK gt to confirm this This will terminate the program and close down the operating system After a short delay you will see a screen that says it is now safe to turn off your computer When you see this screen turn off power to t
29. ter 1 Skin Rejuvenation Procedure Target Chromophores Haemoglobin and Melanin Melanin is produced in epidermal cells called melanocytes and transported to structures called keratinocytes Keratinocytes are destroyed if heated to 70 C for more than 1 ms Haemoglobin and oxyhaemoglobin are found in the blood inside the vessel The light absorbed by the blood is transformed into heat then conducted to the vessel wall The protein in the vessel wall will be destroyed if it reaches 70 C for more than 1 ms As a result the blood will coagulate and the destroyed vessel wall will gradually disappear removing the unwanted small visible vessels and diffuse redness Wavelength Skin Rejuvenation requires the VL 2 Applicator REF 9APP7134 This emits light in the range of 555 nm 950 nm with high absorption in the chromophores melanin and haemoglobin and no absorption by the competing chromophore water Pulse Duration Diffuse redness and pigment is treated using a double 2 5 ms pulse with a delay of 10ms to treat the entire area Energy settings Treatment of diffuse redness and pigment is carried out with very short pulse duration and 7 9 J cm2 Skin Rejuvenation pre treatment care Patients with skin types 1 2 or 3 are good candidates for Skin Rejuvenation procedure Best results are obtained if the patient has a low degree of pigmentation from sun tanning or solarium ACAUTION Note Skin type 4 or suntanned Skin Type 3 should be
30. the ready mode AWARNING Never direct the Light Guide towards the eye Aim away from the eye and treat the cheek bone as the highest point that can be treated If necessary move skin to be treated down over the cheek bone or up over the frontal cranial bone to use the bone as an additional shield Other Patient Related Hazards Injury to the patient s eyes and skin may result from incorrect use of the equipment Always take the following precautions AWARNING Always follow the Patient Parameters Set up instruction detailed in this manual ACAUTION No part of the area to be treated should be covered with any type of metal foil When exposed to light radiation foil may heat up and cause epidermal damage AWWARNING Never use flammable liquids to clean the skin or prepare it for treatment Use soap and water for skin cleaning wash the skin afterwards with pure water and dry it before applying the coupling gel Ensure that no shaved hair is present on the skin or on the applicator AWWARNING Abnormalities of the skin such as pigmented lesions birth marks and tattoos must be evaluated by a medical doctor or dermatologist with experience in photo therapeutics prior to treatment AWARNING The default settings are suggestions only The operator is responsible for patient safety and should only press the Accept button once satisfied that the settings are appropriate No default settings should be accepted unless a thorough dermatological eva
31. tify conditions or actions for which a potential hazard may exist which will or can cause minor personal injury or property damage if the instructions are ignored AWARNING Warning is used to identify conditions or actions for where a known hazard may cause severe personal injury death or substantial property damages if the instructions are ignored Ellipse Light Chapter 1 In order to reduce the likelihood of injury or equipment damage it is important to read the manual and specifically Section 4 Safety before using the equipment Always keep the manual nearby and review the procedures and safety precautions periodically Contact your DDD representative if you have any questions or feel that additional training is required ACAUTION Ellipse Light is a Class Ilb Medical Device Do NOT attempt to install or run any software not provided by DDD on the built in computer system This may adversely affect safety and reliability 1 2 Intended Use The intended uses of Ellipse Light are for medical treatment of changes in the anatomy or of a physiological process in the skin Hair removal permanent hair reduction Treatment of sun damaged skin to reduce diffuse redness and pigment disturbances and improve texture Skin Rejuvenation Future additional information will be detailed on Application Notes as a supplement to the Clinical Work Book Indications for Use aes eee Toei Application Treatment Variable e e Thin Normal
32. tion causing sensitivity to light Patients suffering from long term diabetes or haemophilia Patients tending to produce keloids raised red scars or hypertrophic abnormal amounts of scarring Patients with Sun tanned skin or fever Patients taking topical or systemic steroids or taking non steroidal anti inflammatory drugs as these actively work against the treatment Patients who have smoked tobacco within 4 hours prior to treatment where the target chromophore is haemoglobin Contraindication Notes Although not specifically contraindicated patients who are pregnant or who have a heart pacemaker fitted are normally not treated Hair treatment of pregnant patients is best deferred until 2 3 months after birth as growth of body hair is synchronized at this time Ellipse Light Chapter 2 Chapter 2 TREATMENT SCENARIOS AWARNING Before starting treatment it is important that the operator has understood the technical aspects of using the equipment see Sections 3 and 4 In addition safe and efficient patient treatment requires suitable training in and basic understanding of dermatologic evaluations and interaction between high energy light and human tissue 2 1 General This chapter provides step by step instructions for removal of hair and for Skin Rejuvenation Remember that buttons are pressed by touching the screen where the button is located You can get relevant on screen help by touching the selected setti
33. w ellipse org Ellipse is a trademark of Danish Dermatologic Development A S DDD a producer of light based solutions for medical and cosmetic conditions DDD has gained the acclaim of doctors and beauticians worldwide for the quality of Ellipse products and services Danish Dermatologic Development A S All rights reserved 1MANO132 ENG E08 I
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