New Design Portable IPL Equipment (GSD-801E)
Contents
1. 6 2 Cleaning the Sapphire Crystal The Sapphire crystal must be kept clean at all times Always use a soft damp cloth or wet cotton balls Sanitize the treatment head with alcoholized cotton balls 6 3 Replace the IPL treatment handpiece The IPL treatment head has a limited service life after its maximum life span 40 000 shots You need to call your re seller or dealer for this replacement 6 4 Refilling the water supply Observe the water level through the water observation window at the rear of the unit The water level is best maintained within the midpoint of this window Distilled water can be added by following the instructions seen in Section 4 3 Installation 6 5 System Trouble Shooting Check power cable Check circuit breaker fuse Check key switch No power Disengage the emergency cut off switch by rotating towards the direction of the arrows indicated Notify your distributor Key pads are none j PI contact th ler responsive ease contact the deale Not enough power please check main power supply System failed to initialize y Please contact the dealer The treatment head flash lamp has reached its maximum life span 40 000 shots Replace the treatment head The IPL treatment head is probably damaged please change the IPL treatment head or contact the dealer Malfunction of flash lamp on the IPL treatment head The IPL treatment head is The IPL treatment head2. 1200nm filter for superficial vascular lesions and Acne 510nm 1200nm filter for deeper vascular lesions 8 2 3 Basis of Parameter Selection 8 2 3 1 Skin Color gt The darker the skin the longer the Pulse Width T1 T2 amp T3 and lower the fluence gt The lighter the skin the shorter the Pulse Width T1 T2 amp T3 and greater the fluence 8 2 3 2 Capillary Diameter Small Capillaries Shorter pulse widths Shorter pulse delays Higher fluences Less pulses Larger Capillaries Longer pulse widths Longer pulse delays More Pulses VV VIV VV V Page 38 User s Manual 8 2 3 3 Skin sensitive degree The more sensitive the skin the lower the fluence 8 2 4 Parameters selection See attached treatment parameter sheet 2 4 1 Start with a low fluence i e 25 J cm Do a test shot in an inconspicuous area Evaluate patient response then gradually increase the fluence by increments of 3 J cm when a fluence of around 30 J cm is achieved increase by increments of 1 or 2 depending on patient s response We strongly recommend that for the 1st treatment the fluency level be set initially at least 8 to 10 joules sq cm below the suggested level of treatment parameter sheet Please note that treatment over bony areas such as the malar area forehead and shins produces more discomfort so reduce the fluence by 2 3 joules 8 2 5 Treatment Evaluation There are three end results of treatment 1 disappear
3. Pulse width 0 5 20ms Repeat frequency 1 6Hz Page 43 User s Manual Deliver system Direct sapphire Coupling Spot size 8mmx40mm Operation interface 8 4 touch Ture Color LCD Cooling system Cooling system Water cooling forced air cooling and semiconductor cooling Cooling temperature 4 c 0 c The distributor reserves the right to modify upgrade the specifications without prior notification Fitzpatrick Classification of Skin Types SKIN TYPE COLOR CHARACTERISTICS Light skin Always Burns Never Tans Il Light skin Always Burns Sometimes Tans Il Light skin Oriental Sometimes Burns Always Tans IV Brown skin Never Burns Always Tans V Negro Skin Never Burns Always Tans Annotations 1 the technics items in the manual may be improved please contact our company as request 2 Electric princlPLe diagram and part list will be provided as request Page 44
4. 29 6 5 System Trouble Shooting sis 30 Chapter 7 Clinical ApplicatioN ocoooooossmsssiissss 31 E tn nn en Re ne ee toss tre ne re trees tete iste Ain A 31 T Z APPIICAION a ST 31 PQA Selective ThermolySIS write ee anexas 31 7 2 2 Treatment Range i cccccceccecesscessesessecvsconccecseuscenceuceuadetcesacentouaceatenacuacesdesatentetacencenceacensenscendenaseates 31 7 2 3 Overview of Areas Sensitive to Pain 31 FAGOR em Rs AT RS UM ee PS ae naman aaa Oe eee a be nine 32 BOY RME do AR ARR MR Rasa Nea ea ee 32 FDA COntramdicatiONs s Le E E dde And nee de ee da EE dedans a des da 32 TS Th treatment must KNOW ER Re ais 33 7 4 Preoperative Preparation ss 33 TAM OLT a A A dense sugendevdssded danse E 33 TALE AO o nn 34 1 43 Optical Protec lo pc as e alo to ns 34 DA Anesthesia A A ias 34 7 4 5 Photographic Documentation 34 1 3 Untoward Reactions eseni rennon en ee EE Re NN eee 34 LAO SR eee 34 7 5 2 Scab formation 34 1 53 Pigmentation Changes Men nn tt eed M A A ent oe NAS 34 1 5 AS Cab TOMA A costes ote SM O ab Son IN 34 7 5 5 Swelling and Erythema cccc ccccccecssesssccssstecsesctacessenectecssectesesdenccresstactessdecseeesebadscsdenenseeteetesees 35 7 6 Treatment ParaMeters ico ssl caceria ne nn rte 35 VOL Brief Introduction 2 Aid 35 1 6 2 PIM A hab edb ah ad 35 7 6 3 Parameter PrincIPLes iii 36 TOA Lasht couplitig Gell ict icici thant add 36 PT Fe Procedure rien
5. Crystal Display shows the operational settings and adjustments as well as system status is displayed on the screen 3 1 3 The IPL treatment handpiece The IPL handle consists of a 1 Cable housing this contains the power cable liquid coolant tubing control data cable 2 IPL head this houses the control switch flash lamp sapphire crystal filter piece and electronic semi conductor cooling system Depressing the trigger on the IPL treatment head discharges the flash lamp at the settings as displayed on the control panel Depressing the foot switch like wise discharges the device on selected models only The supplied sapphire crystal measures 12mm x 40 mm and is superior in both clarity and longetivity thereby increasing both the efficiency of the flash lamp and lifespan of the treatment head It is very important to keep the sapphire crystal clean Make sure to clean this with a soft cloth after each treatment A disinfectant such as alcohol can be used between treatments Dried gel on the crystal filter will reduce efficiency of the flash lamp Replace the plastic guard over the filter to prevent damage In the event that the sapphire crystal is damaged i e nicked or cracked contact your dealer immediately 3 2 Accessories The accessories of this device include The IPL treatment head s 2suit Filter piece 3pc Protection glasses operator 1pair Protection goggles patient 1pair Users manual 1pc Drainage hose 1pc Funnel 1pc P
6. cable Handpiece holder including four screws Foot switch Funnel Plastics hose Key User s manual 4 2 Installation requirements Before unpacking the IPL Photorejuvenation treatment systems ensure that working environment conforms to the requirements of this section Before assembly of the device s components ensure that high humidity is cleared away by opening the packing and staying the device for one day 4 2 1 Location requirements The device should be positioned in an area with adequate ventilation away from devices that produce heat i e refrigerator Page 17 User s Manual 4 2 2 Electrical Requirements Before the IPL leaves the factory it has already been marked the local rated voltage according to the customers request It corresponds to the electricity requirement as follows AC220V 10 lt 10A 50 60Hz or AC110V 10 lt 20A 50 60Hz Input electric current can t have momentary change electric voltage or electric current peak sink It is recommended that this device use a dedicated power supply with its own circuit breaker ZN CAUTION Ensure that the electric voltage rating of this instrument AC220V or AC110V refer to system labeling matches the electric voltage of the outlef 4 2 3 Environment Requirements Air quality No caustic particle such as acid in the air which can damage the electric wire the electric component and optical component surfaces The dust in the air sho
7. clockwise direction At this time water Page 19 User s Manual circulation and the cooling system starts automatically 8 Observe whether water circulation runs well or not After cooling system runs for at least 1 minute the water slide into the cooling system and then turn off the power If the system sounds beep and show water current error then you need to move out the bubble air from the system Switch the unit off take off the protection plug of water conduit as Figure 4 4 then switch on the power meanwhile the water will spout out from the front of water conduit 9 If the water circulation run well Then switch off the system It means you can fully assemble system with handpiece screw on the infusion cap and ventilation caps When installing a new treatment handpiece or switching between treatment handpiece place the treatment head lower than the main host in order to remove bubbles from the treatment head Then turn the device on Let the water circulate for at least 1 minute before proceeding with the treatment Installation treatment handpiece please follow the figure pull out the protection plug for water conduit first 10 11 12 Plug the handpiece connector firmly and properly to avoid the water circulation problem 13 lt According to the following figure changeable of the various wavelength by 560 640 690 1200nm filter for FP standard specification for spot size 12x40mm
8. desired a For units GSD 801E with 4 in 1 hand pieces i Place the unit on standby by pressing the simmer key ii Insert the desired filter 510 560 640 690nm iii Select Treatment Mode and resume treatment b For units GSD 801E with single treatment hand pieces i Place the unit on standby and turn off the unit ii Replace the treatment handle 560 nm or 640 nm iii Turn the unit on select the desired treatment and resume treatment 12 Whenever the unit is not in use set the IPL on standby by pressing the simmer key to extend the life of your flash lamp 13 Turn Off the unit and clean the treatment heads D MPAA NA 7 8 Post Operative Nursing Care 7 8 1 Sun Avoidance As with other forms of treatment the treatment area should be protected from sunlight exposure An SPF 15 or greater physical sun block is recommended Avoidance of direct exposure is also recommended 7 8 2 Deoderant For axillary hair treatment it is recommended that deodorants and shaving be avoided for the 24 48 hours after treatment 7 8 3 Cosmetics There is no contraindication to wear make up after treatment Likewise the patient may return to work immediately after treatment Page 35 User s Manual 7 8 4 Follow up Treatment The treatment duration of IPL therapy extends for a few months Patients should be reminded of there follow up schedule as to maximize the efficacy of the treatment Please refer to the provided treatme
9. enter the Treatment Mode Selection Menu 3 Select the desired treatment by touching PIGMENT HAIR REDU BREAST REJUV mode buttons 4 Touch Up and Down button on the screen to modify the parameter settings After the desired parameters have been settled the Energy output can be adjusted by touching the UP and DOWN buttons 5 Touch the Ready to simmer and ready for treatment 6 Observe proper optical safety by wearing the safety goggles provided with this device Opaque for the patient and filtered for the operator 7 Apply a thin layer 2 3 mm of cold gel over the entire treatment area While exerting light pressure approximate the treatment head perpendicularly over the treatment area And press the Trigger button on the treatment handle to begin treatment 8 Evaluate the treatment area for any untoward side effect such as pain During treatment the parameters can be adjusted as to your requirements Page 26 User s Manual 9 Before moving on to the next treatment area gently remove the gel from the previously treated area and apply a cool compress cold gel pack 10 After treatment copy the treatment parameters to the patient s record sheet and place the device on Simmer or Standby Mode by depressing the Ready key 11 Turn off the device by turning the key counter clockwise Clean the IPL treatment head with a soft cloth Then sanitize the treatment head with alcoholized cotton balls 12 Repl
10. i e PIGMENT mode as highlighted on the screen see figure 5 2 NOTE For systems GSD 801E with changeable filters turn the system on then select the proper filter i e 640 nm for hair removal and gently insert it unto slot of the treatment head Then select the desired treatment Replace filters only when the device is in standby simmer mode 4 Treatment Parameter setting Parameter setting from AMT P pulse number Pulse1 Delay1 and Pulses Delays or Touch Parameter setting get into the bigger screen as see Figure 5 3 The max pulse sequence is 15 Pulses duration 10ms Pulse delay time is 50ms Touch the Up and Down button will allow you to modify the highlighted parameters Touch the Enter button to return to previous Menu Figure 5 3 There are 8 treatment parameters that can be individually adjusted Such as Figure 5 4 The energy output or fluence is the total energy measured in Joules cm Because of the large spot size 8 x 40 mm the scattering effect of light is minimized The higher the fluence the greater the amount of energy is delivered to the skin The fluence can be increased or decreased at the Treatment Menu by depressing the Up or Down button respectively The fluence of this system can be adjusted from 1 up to 60J cm2 Pulse Times NdP the fluence can be divided from 1 up to 15 pulses Because the power of the system can be divided into a series of pulses unlike the previous g
11. of GSD 801E slot Figure 4 4 14 When replace the treatment handpiece or replace water 1 Drain the remaining water which contains in the handle Pay particular attention as not to spill any water on the electronic terminals Wipe off any spilled water with a soft absorbent cloth 2 Replace water every 2 3 months please carry on according to the following steps strictly Disconnect handpiece But you need to keep the above part as Figure 4 4 on the water conduit of handpiece Turn on the infusion drain tap and unscrew the ventilation screw caps as Figure 4 1 Page 20 User s Manual AUNA a To drain excess water from the cooling tank Turn on the drain tap insert the drainage hose supplied then open the ventilation screw cap Fasten all screw caps firmly ZN CAUTION Only distilled water is to be used in the cooling system When using the system for the first time rinse the cooling system with distilled water Ensure that the water level is adequate before treatment to prevent over heating Distilled water is added periodically specially when working in warmer climates and when the treatment handpiece are changed often Make sure that the treatment head is firmly secured and the screw caps are firmly screwed into place prior to operation 4 4 Move If the device is to be moved within the general area 1 2 3 4 Turn the device off Put the treatment handpiece on the support cradle Pull out t
12. 2 8 3 3 Parameter Selection 21588 E 42 8 34 Treatment valuations it A RO nl re AU Le 42 8 3 5 Treatment periods iii dada 42 SRS Bt A A EE A EA 43 8 358 Post Treatment Care sot E TE EE E 43 8 3 9 Follow up Consultation ses 43 8 4 PHOTOREJUVENATION 8 DEEP SCARS issus 43 8 4 1 Treatment PrincIPLe usines 43 8 4 2 Available Balter tas een 43 8 4 3 Parameter Selec dbavasdeve 43 8 44 Treatmentevaluation llosa 44 IO AA ss ore taken ees Ph ahaa AA N E A elutes 44 3 40 Post Tr Menta antennes dise Pantone vivido 44 8 4T Follow up Consultation faste nina A dea 44 Chapter 9 Specifications ds Fitzpatrick Classification of Skin Types 46 Using this User s Manual This User s Manual is divided into the following sections Section Contents Preface Brief technical overview and Medical use Safety General safety precautions when operating the device Description Description of the components and controls Installation Introduction of the installation and transport procedure Operation Operation of the device Maintenance Maintenance information Clinical Application including application range treatment process and side effect Parameters selection Basis of parameter selection and treatment evaluation Specifications Brief overview of the specifications Pay Attention to Warnings Cautions and Notes WARNING Warning means that not following instructions prope
13. GSD 801E IPL Photorejuvenation Treatment Systems User s Manual Mi Mil Contents Using this User s Manual sssssessoscsssossessosssosoosossoosossoesoosossoosossossoossesoesossoosossosssssosssssosssssosssssssssssssssse Chapter 1 AAA A 7 Pi Rs Ne aie Re Re eee nf AN nt 7 1 2 Device brief introduction ss 7 ADECCO MU nn set ls LU ne ne lee etal 7 1 4 Medical Use Application Areas 8 Chapter 2 Satety AAA AAN 9 2 41 Introduction 522523 sac ss niet A er dencre dede eR NG Ee sees 9 2 2 Responsibilities of the User 9 22 l Safety Measurement a 9 2 2 2 Safety Warm Ss sr EAEE aee NEE ET dans riens REEE ere t net 9 PA A A ss nes a eee ten NS 10 2 4 Explanation to Patients sisi 10 2 5 Optical sei traido 10 DIM IO EA A A Is 10 25 2 Tr atment RGO A ee en An E Rte 11 2 6 Electrical and machine safety 11 2 7 Fire pr ventiOni stainless dt Rea neh hea ent ten este Titan tal 11 2 8 System safety siennes 11 2 9 Safe classification of equipments s 11 2 10 able ot QUIM iii a E ice 12 Chapter 3 DescriptioN omommommsssmsssmsssmmssssmsssssssssss 14 IALPARS and CONO a cn 14 LM A ds 14 AA e e lle er eut de 15 3 1 3 The IPL treatment handpiece ss 15 3 2 ACCESSONIGS o e nt tir at dale e oaths ls Tr Ent 15 3 2 PUR E 5h NE 16 3 2 2 Protection DlASSes td edad 16 3 2 3 Light c upling gel neien aaa 16 IAA Or
14. ace the treatment handle on its carriage and unplug the device NOTE Disinfect the treatment head after each treatment Schedule your patient for subsequent follow up to evaluate future treatment At the end of clinic hours remove the IPL handle cover and remove any gel that may have accumulated with a soft darnp cloth WARNING 7 Do not point and operate the device elsewhere other than the intended treatment area 2 The light generated by this device is very intense Exercise Optical safety measures by wearing the protective goggles Avoid looking directly into the treatment area during operation even when wearing the goggles Chapter 6 Maintainance This chapter describes the regular maintenance that can be performed by the owner Authorized personnel must do any other maintenance work not described in this chapter System troubleshooting is also enumerated in this chapter WARNING Before any maintenance work turn the power off and unplug device Failure to turn off the power may cause an electric shock damage to the device and bodily injury Never attempt to remove the back panel or device casing Unauthorized tampering with the devices internal system Will automatically void the warranty 6 1 Cleaning the Main host The main host casing or body must be clean with a soft damp cloth A mild detergent may be used but be cautious as not to let liquids from entering the units internal mechanism Page 27 User s Manual
15. aia cast AEA EE E eh inner e fran sense Bette tea 37 7 8 Post Operative Nursing Care 37 PIB IL SUN AVOIGAN tasa loa 37 178 2 D Odetant sess Mcrante A a ace cn 37 1 8 3 Cosmetics sn A Len A DR ne ER NEE I OAs 37 ESA Followup Treatments state Me tartes e dde 38 TS Adverse REACCION a anus 38 7 9 The advantage of the IPL treatment 38 Chapter 8 Parameters Selectiony s csssscccscsssssesssssssssscsssssssssccssssssssscssssesssessssssscsssesssssessssonssssesses 39 8 1 Treatment of Pigmented Lesions 39 8 l 1 Treatment prnl e iia 39 8 1 2 Available Filters iii 39 8 1 3 Basis of Parameter Selection 39 8 14 Parameters S lections nmrnm nine int ee cine Didi deal AEEA 39 8 1 5 Treatment Evaluation tue ee ASE nn St ee ne Re 39 SUL G6 Adverse Effects icc ti E ASE AE E en TT CS RE A A a nee 40 8 1 7 Follow up Consultation ses 40 8 2 Treatment of Vascular LESIONS amp ACne 40 8 2 1 Tr atmentprincIP Le dire ann nie de ter eee dant rte drn etant dl etre res tags dee 40 3 2 2 Avallable Filtra leurs 40 8 2 3 Basis 0f Parameter Sele Ctl OM asii dada tata als 40 8 2 4 Parameters selection 41 8 25 Treatment EVO Ea 41 8 2 6 Adverse ES ii ica 41 8 3 Hair Removal rio bese ax Re en laa 41 8 3 1 Treatment princ PES oa eaea oeiee dt added 41 8 3 2 Available Filters innnan ein ts Ae os 4
16. ance of capillaries 2 decrease in diameter of the capillaries 3 coagulation of the blood vessels from a red to a reddish brown or purple color Avoid over treating an area as it may lead to blister formation 8 2 6 Adverse Effects Erythema and discomfort after treatment is treated with cold packs until the discomfort subsides Erythema normally subsides over a few hours for lighter individuals and may take longer for darker skinned individuals Blisters normally dries up after a few days and the scab generally falls off in 1 to 2 weeks An antibiotic ointment can be applied to prevent infection and to hasten healing Post inflammatory pigmentation can be treated with topical retinoids 8 2 7 Follow up Consultation Follow up consultation is highly recommended specially when post treatment complications such as blister formation are noted Follow up treatment is only scheduled when adverse effects have been resolved Please see attached follow up treatment schedule in the treatment parameter chart attached 8 3 Hair Removal 8 3 1 Treatment princlPLe Using the 640 nm 1200 nm filter maximizes the selective targeting of melanin pigments in the hair strand Light absorbed by the melanin in the hair is converted to heat and effectively destroying the hair follicle The princlPLe of selective photothermolysis takes advantage of the amount of pigment found in hair The greater the amount of pigment the more effective the Page 39 User s M
17. anual treatment 8 3 2 Available Filters gt GSD 801E Multi filtered units 640 1200nm filter or 690 1200nm 8 3 3 Parameter Selection Dark hair Shorter pulse width Light hair Longer pulse width Deep hair Longer pulse width Superficial hair Shorter pulse width Thick hair Longer pulse delay amp lower fluence Thin hair Shorter pulse delay amp higher fluence Dense hair growth Lower fluence Sparse hair growth Higher fluence Darker Skin color Longer pulse delay amp Lower fluence Lighter skin color Shorter pulse delay amp Higher fluence More sensitive skin Lower fluence Less sensitive skin Higher fluence See attached treatment parameter sheet Start with a low fluence i e 25 J cm Do a test shot in an inconspicuous area Evaluate patient response then gradually increase the fluence by increments of 3 J cm when a fluence of around 30 J cm is achieved increase by increments of 1 or 2 depending on patient s response We strongly recommend that for the 1st treatment the fluency level be set initially at least 8 to 10 joules sq cm below the suggested level of treatment parameter sheet Please note that treatment over bony areas such as the malar area forehead and shins produces more discomfort so reduce the fluence by 2 3 joules When treating very densely pigmented areas reduce fluence by 2 3 joules 8 3 4 Treatment evaluation Generally the patient will note a
18. der acesti E ean NEGE Irai 16 3 3 System SOftWare iii 17 3 4 The environment requirements 17 Chapter 4 Installation 18 4 1 Equipments detailed list 18 4 2 Installation requirements sise 18 A D1 TOCatiOn r qUIT MENTS ii A nn a a ved entes a 18 4 2 2 Electrical Requirements sise 19 4 2 3 Environment Requirements ss 19 A SHINS re NEELIE n ces Phase a al oo A Miser ia eel dd e cd eee tah 20 AA MOVG ests facts teehee cian este divs ee ER Re Mn E evened nz 23 4 5 transport and storage procedure 23 AS LPrOCeQUT LS ch e Une MAN e Led E er nn ur urnes 23 52 ENV TONED a a Mee end MAR M te tae PE Mn porn ee a eee ae 23 Chapter 5 Operatlonm icssscsssseessccocassscssseacsenssssscasasssescecasssesssssesenensecsesacssecsosesssbodsossoonsssensssadecoseassessesseas 24 5 1 Software operation explanation non ncnnonncnnnnncnnnnos 24 5 2 Treatments finir de ne ee n e de 28 Chapter 6 Maintainane siiiciissississcccssccscoscsosescesstcatssdsestcetesvoceteosvaccsessasiescssesecsesnesevesssessessessas escsososvesseves 29 6 1 Cleaning the Main host 29 6 2 Cleaning the Sapphire Crystal 29 6 3 Replace the IPL treatment handpiece conan 29 6 4Retillingsthewatersupply nono noncoroncnronan nono
19. e hair removal VL 480 1200 nm Acne and Telangiectasia SR 585 1200 nm Vascular lesions telangietasis alleviation by photothermic activity HR 755 1200nm Permanence hair removal Item 7 9 are optional items FeO OO OD OV BS UNE 7 2 3 Overview of Areas Sensitive to Pain Face Figure 7 1 Pain zones of face Body Page 30 User s Manual Figure 7 2 Pain sensitive zones of body 7 2 4 Contraindications A Warning The following are relative contraindications for treatment with Intense Pulsed Light Inflammatory dermatosis Cutaneous Infections Immune system defect History of keloid formation Psychologically ill patients or has had the high expectations Pregnancy Skin cancer Bleeding disorders Photodermatoses 0 On medication known to cross react to light 7 3 The treatment must know AN Warning To the sufferer before carrying out the treatment please reading this segment in detail a o N o g Prior to treatment the physician must first get a detailed history rule out any disorders that may contraindicate this treatment and finally physically inspect the treatment area Cosmetics should be removed with non alcohol containing neutral cleansing agent such as Bactolin Cetaphil Gentle Skin Cleanser or Celeteque Facial Wash Apply a generous amount of cooled gel non tinted on the treatment area A slight erythema may appear after the procedure This is normal and will
20. eatment evaluation Generally the patient will note a mild discomfort liking to being flicked with a rubber band As the fluence is increased so does the sensation When a desirable fluence has been achieved you will note minimum discomfort accompanied by mild erythema amp swelling of the skin Occasionally a burnt skin like odor can be observed 8 4 5 Side effect Erythema and discomfort after treatment is treated with cold packs until the discomfort subsides Erythema normally subsides over a few hours for lighter individuals and may take longer for darker skinned individuals Blisters normally dries up after a few days and the scab generally falls off in 1 to 2 weeks An antibiotic ointment can be applied to prevent infection and to hasten healing Post inflammatory pigmentation can be treated with topical retinoids 8 4 6 Post Treatment Care Apply cool packs after treatment of each area before moving on to the next treatment area For persistent erythema mid potent topical steroids can be applied For areas of blister formation an antibiotic ointment can be prescribed Post treatment it is recommended not to shave and not to apply deodorants for 24 to 48 hours It is strongly advised to avoid sun exposure and to use a sun block 8 4 7 Follow up Consultation Follow up consultation is highly recommended specially when post treatment complications such as blister formation are noted Follow up treatment is only scheduled when adverse eff
21. ects have been resolved Please see attached follow up treatment schedule in the treatment parameter chart attached Page 42 User s Manual Chapter 9 Specifications This chapter specifies the most important technical data and system classification for the IPL Photorejuvenation treatment systems Specifications Parameter Data Electrical connection data Line voltage 120VAC or 220VAC refer to system labeling Line frequency 50 60Hz Max power consumption 2000W System classifications Type of protection against electrical shock Class 1 equipment Degree of protection against electrical shock Type BF equipment Degree of protection against harmful ingress of water Ordinary equipment Climate during operation Ambient temperature 15 C to 30 C Relative humidity 30 to 80 Atmospheric pressure Climate during transport and or storage Ambient temperature 86 0 kpa to 106 0kpa 5 C to 55 C Relative humidity 30 to 80 Atmospheric pressure 86 0 kpa to 106 0kpa Dimensions and weights Height 690mm Width 590mm Depth 610mm Weight approx 30Kg Therapy IPL Light source Intense pulsed light Xenon Flash Lamp Spectrum range 420 1200nm Energy density 1 60J c m Pulse method Intense pulsed technology can adjust Pulse sequence 1 15 pulses Pulse delay 10 50ms
22. eneration of IPL units the treatment is less painful and more effective in patients with darker skin types Page 24 User s Manual The Pulse Width or Pulse Duration Pulse1 Pulses is the length of time that the skin is exposed to the pulse of light The larger or darker the lesion the longer it will take to heat up as compared to smaller lesions or those with less pigment The Pulse Delay Delay1 Delays is the resting phase between pulses i e between first and second pulses this delay or rest phase allows the surrounding normal epidermis to cool down prior to initiating the next pulse First Second Third First First Delay Second Repeat Pulse interval Figure5 4 A NOTE A list of suggested parameters is provided by apolo territory distributors Always refer to this set of parameters prior to treatment Please remember that these data are used mainly as a guide and are not absolute 5 Temperature adjustment for Handpiece tip Touch the Up and Down button within Refrigeration will allow you to modify temperature of Handpiece tip Skin Rejuvenation La T Temperature reatment Adjustment Parameters Energy Output 34 014V Bj MS Figure 5 5 6 Simmer Touch the Enter to simmer and ready for treatment see Figure 5 5 7 Energy adjustment Page 25 User s Manual Once the parameters have been satisfactorily adjusted In the Treatment Menu Screen the energy o
23. ents safe classification Electric shock protection class I type BF equipment Corrosion preventing liquid commonness Can t use this IPL system in the environment where the combustibility anesthetic and the air or carbon monoxides mixture exist Operating mode Consecution 10 2 10 Lable of equipments 1 NAME PLATE Model LABEL Position back side Model Name GSD 801E Product Name IPL Photorejuvenation Treatment Systems Power Supply 220V 50 60Hz lt 10A SN f Before operating and maintaining the IPL Photorejuvenation treatment systems please read user s manual in detail 2 WARNING LABEL Position front side A WARNING PROTECTIVE EYEWEAR MUST BE USED RISK OF EXPLOSION IF USED IN THE PRESENCE OF FLAMMABLE ANESTHETICS 3 CAUTION LABEL Position cover back side 11 CAUTION before use refer to accompanying documents To reduce the risk of electric shock do not remove cover No user serviceable parts inside Refer servicing to qualified service 4 CAUTION LABEL 5 DANGEROUS VOLTAGE WARNING LABEL Chapter 3 Description This chapter will introduce the main parts of the system the accessories and the process of installation amp debugging 3 1 Parts and control The IPL Photorejuvenation treatment systems are composed of the following parts 3 Main unit gt 1 Control panel 2 IPL Treatment handpiece Figure 3 1 Main parts of the IPL Photorejuvenation treatme
24. er that is best suited to target dark pigments such as melanin The Skin Rejuvenation Head SR encompasses a broader spectrum 560nm of treatment The Skin Rejuvenation parameters are best suited to target collagen fibers which stimulates collagen regeneration This stimulation of collagen regeneration is best suited for the treatment of fine superficial static lines wrinkles and the treatment of enlarged pores and superficial acne scars The Vascular VL and Pigmented PL parameters are selective for red blood cells and dark pigments respectively which makes them suited for the treatment of superficial vascular and pigmented lesions Though this device does not generate significant thermal energy as compared to lasers it does produce sufficient thermal energy and when coupled with proper filtering and proper physician technique is a very powerful tool for the aesthetician in his or her practice This unique nature of the IPL photorejuvenation treatment systems causes no down time and allows the Page 29 User s Manual patient to resume work immediately right after treatment 7 2 2 Treatment Range VL 420 1200 nm Acne and telangiectasia VL 510 1200 nm Telangiectasia and fine superficial vein PL 510 1200 nm Freckles superficial melasma caf lait SR 560 1200 nm Fine static wrinkles hair pores scars skin tightening whitening HR 640 1200 nm Permanence hair removal HR 690 1200nm Permanenc
25. f the system can now be adjusted by touching the Up and Down buttons 8 Back After completing the treatment place the device on simmer standby mode by touching the Ready button This will terminate the active treatment phase and disengage the flash lamp Please note that by going on Stand by mode the service lifetime of the treatment handle is maximized Touch the Back to return to the Main menu Then you may switch off the power system NOTE After completing the procedure place the system on standby by touching the Back button This will allow cooler operating temperatures and will also prolong the life of the flash lamp 9 CLEAR current treatment shots counting The system will be automatic clear current counter after switch off GSD 801E Shot number will be regressive shot of numbers from the initial writer by IC card It only works when IC card online The shot number should be writing by writer card which is a proper design by FP 10 Password Note Password for engineer only 5 2 Treatment 1 Select the filter i e 640 nm for hair removal for changeable handpiece units GSD 801E plug the filter firmly and properly prior to turning the device on 2 Turn the device on by turning the key switch in a clockwise direction The screen will show the main menu and will undergo a systems check up diagnostic program See figure5 1 After select any one of language by touch of screen the program will then
26. fade gradually in a few minutes to hours Always record the parameters fluence shots and the area treated after each treatment Apply a cold compress prior to proceeding to the next treatment area Avoid use of cosmetics for 24 hours after each treatment Avoid sun exposure after each treatment Page 31 User s Manual 7 4 Preoperative Preparation 7 4 1 Inquiry 1 Avoid sunlight artificial UV light exposure 3 4 weeks prior to treatment 2 Discuss current treatment plan 3 Clarify and confirm patient s expectations 4 Rule out any conditions contraindicating this treatment 7 4 2 Explanation 1 Discuss the possible number of treatments required for treatment 2 Inform the patient regarding the possibility of a stinging warm sensation during treatment 3 Inform the patient regarding the possibility of transient erythema 7 4 3 Optical Protection 1 The patient should wear the protective opaque eye goggles 2 The Physician should wear the protective filtered translucent eye goggles 7 4 4 Anesthesia 1 In general anesthesia is not required during the treatment with IPL 2 Discomfort is reduced because of the built in cooling semiconductor in the treatment head 3 Discomfort is also reduced by using refrigerated coupling gel 4 For patients with poor tolerance 4 lidocaine cream is preferred over EMLA during the treatment of vascular lesions EMLA causes some vascular constriction 7 4 5 Photographic Docume
27. fort and that blister formation followed by scab formation is to be expected Page 37 User s Manual Please note that treatment over bony areas such as the malar area forehead and shins produces more discomfort so reduce the fluence by 2 3 joules When treating very densely pigmented areas reduce fluence by 2 3 joules 8 1 6 Adverse Effects Erythema and discomfort after treatment is treated with cold packs until the discomfort subsides Erythema normally subsides over a few hours for lighter individuals and may take longer for darker skinned individuals A blister normally dries up after a few days and the scab generally falls off in 1 to 2 weeks An antibiotic ointment can be applied to prevent infection and to hasten healing Post inflammatory pigmentation can be treated with topical retinoids 8 1 7 Follow up Consultation Follow up consultation is highly recommended especially when post treatment complications such as blister formation are noted Follow up treatment is only scheduled when adverse effects have been resolved Please see attached follow up treatment schedule in the treatment parameter chart attached 8 2 Treatment of Vascular Lesions amp Acne 8 2 1 Treatment princlPLe The target chromophore for vascular lesions is hemoglobin The light absorbed by hemoglobin is converted to heat thereby effectively cauterizing the endothelial walls of capillaries 8 2 2 Available Filters GSD 801E Multi filtered units 420nm
28. he power cable Relocate the unit Avoid tilting the device ZN CAUTION f the instrument is to be moved outside the hospital please contact your dealer 4 5 transport and storage procedure 4 5 1 Procedure 1 Drain off and cleaned the water from device before keep storage and transportation 2 The instruments should vertically be installed in the outer packing box during transport The instrument is fixed on the base gt 690mm X 590mm Xx 600mm so that the wheels of the instrument Page 21 User s Manual will not glide 0 3 3 There are waterproof and soft gasket material in the outer packing box of the instrument and handle with care which the instrument should be supported by natural damage The markings such as Handle with care No wetness up should be on the box 4 5 2 Environment 1 Environment temperature range 5 C 55 2 Relative humidity range 30 80 3 Atmospheric pressure Range 86kpa 106kpa Chapter 5 Operation This chapter will describe the operating procedure of the IPL Photorejuvenation treatment systems N WARNING WARNING HIGH VOLTAGE please ensure that all panels are secured prior to operation Place the IPL treatment head on its support when on standby simmer mode All personnel in the treatment room must wear the protective filtered glasses supplied Make sure the patient is wearing the opaque protective goggles prior to treatment Avoid looking directl
29. his method of selective photothermolysis makes use of time and light modulation to ensure that the target chromophores remains heated as the surrounding epidermis is cooler 7 6 4 Light coupling Gel The light coupling gel is best used chilled It is spread thinly 2 3 mm over the treatment area The gel is used to cool down the treatment area before and during treatment By pre cooling the skin and by absorbing heat from the epidermis discomfort is kept to a minimal The use of coupling gel is also helpful in determining the areas that has just been treated by observing the footprint left behind by the treatment head Page 34 User s Manual 7 7 The Procedure Remove cosmetics from the treatment area and clean with a mild soap Attach the proper treatment head filter Turn the IPL unit on and enter appropriate parameters Use the appropriate protective eyewear Apply a thin layer of coupling gel 2 3 mm Set the treatment head parallel to the skin s surface and begin treatment Avoid excessive overlapping of treatment areas Avoid doing double passes For the first treatment a test shot over an inconspicuous area can be performed 7 After treating an area carefully remove the gel and apply cool compresses 5 10 minutes 8 Watch out for side effects such as burns pain and erythema 9 Proceed to the next treatment area 10 Treatment parameters before proceeding to the next treatment Note down 11 If a different treatment is
30. hromophores are not exposed to the intense pulsed light The pulse delay allows the target chromophores to remain heated and the surrounding epidermis to cool down before exposure to the next intense pulsed light Page 33 User s Manual 7 6 3 Parameter PrinclPLes The darker the skin Decrease the fluence Increase the pulse delay allow more cooling The lighter the skin Increase the fluence Decrease the pulse delay Decrease the fluence Increase the pulse delay allow more cooling The darker the hair pigmented esion Increase the fluence Decrease the pulse delay The lighter the hair pigmented lesion Fine blood vessels higher fluence Decrease the pulse delay Decrease the pulse width Thicker blood vessels Increase pulse delay allow more cooling Increase the pulse width The smaller the target size lesion Decrease pulse delay The larger the target size lesion Increase pulse delay allow more cooling IN NO IN IN NN RD gt a Bony prominences forehead malar area shins Decrease the fluence by 10 20 During the interval of active treatment Pulse Width T1 T2 amp T3 the target chromophores is exposed to the Intense Pulsed Light it then absorbs light energy and produces heat This heat is then dissipated during the passive treatment phase Pulse Delay D1 amp D2 to allow for the surrounding epidermis to cool down and to prevent burns Therefore t
31. imum energy remaining in the capacitor is 1000J as a residue voltage It is not advised to open the cover This will result in an electrical shock Do not open the control or rear panel even if the unit is switched off Only authorized personnel may repair or maintain the IPL unit Tampering with the unit will void its warranty 2 7 Fire prevention The intense pulsed light device generates thermal energy Avoid using combustible material such as acetone or alcohol in the operative field If alcohol based products are used to disinfect the IPL device ensure that the alcohol has completely evaporated prior to operation 2 8 System safety The key switch is used to turn the unit on and off Please remove the key when the unit is not in use to prevent unauthorized access The emergency cut off switch is used to shut down the device in case of any emergency After engaging the emergency shut off button turn the device off by rotating the key in a counterclockwise direction Rotating the emergency cut off switch in the direction indicated by the white arrows will release the button A 10 ampere circuit breaker is installed behind the device adjacent to the power cord Loads in excess of 10 amperes will trip this switch Simply moving the switch upward will restore power to the system A self diagnostic program then initializes the system and will continuously monitor the circuitry during operation 2 9 Safe classification of equipments The equipm
32. is probably damaged please leaking change the IPL treatment head or contact the dealer Page 28 User s Manual The system is designed for continued used for up four hours in optimal environmental temperature and humidity Always place the system on standby mode while awaiting The treatment handle is treatment The system might have been left on for an warm extended period Turn the unit off let it cool down for half an hour then re start Contact the dealer The treatment head has nearly reached its maximum life span 40 000 shots the fluence can be adjusted by a few joules to compensate The power of The IPL treatment head has weakened Chapter 7 Clinical Application 7 1 Training Only professional personnel with appropriate training may operate this device Unauthorized use or abuse in the hands of a novice may cause thermal injury to oneself or others and may cause irreparable damage to the unit 7 2 Application 7 2 1 Selective Thermolysis The Intense Pulsed Light system works on the basis of selective thermolysis The technology of which is similar to that of LASERS Intense pulsed light as the name implies is a concentrated amount of light energy that is produced by a Xenon flash lamp in the broad spectrum of 400 to 1200 nm Different types of filters can be attached to the unit to limit the wavelength spectrum of the intense pulsed light The Hair Removal Head HR uses a 640 nm filt
33. lling and Erythema Some transient swelling and erythema can occur especially during photo rejuvenation This is normally transient and can be treated with cool compresses 5 to 10 minutes and mid potent topical steroids such at betamethasone valerate or momethasone furoate can be applied for 1 to 2 days 7 6 Treatment Parameters 7 6 1 Brief introduction The parameters are settings or set of instructions given by the user to the computer in order to modulate the light produced by the Xenon flash lamp The therapeutic effect of this device depends on the proper selection and use of these parameters 7 6 2 Parameters 1 Wavelength Refers to the spectrum of light emitted by the xenon flash lamp between 400 to 1200 nm 2 Fluence The intensity or level of power emitted by the flash lamp measured in joules cm Generally the greater the fluence the greater amount of light and heat is produced 3 Number of pulses The energy of the each pulse can be divided into two three or five pulses This method of treatment prevents epidermal burns by allowing the target chromophores to cool between pulses 4 Pulse width The duration of light exposure T1 T2 amp T3 measured in nanometers ms This is the duration of time that the target chromophores absorbs filtered light energy from the xenon flash lamp 5 Pulse delay The duration D1 amp D2 between Pulse widths measured in ms This is the interval between pulse widths when the target c
34. mild discomfort liking to being flicked with a rubber band As the fluence is increased so does the sensation When a desirable fluence has been achieved you will note minimum discomfort accompanied by curling or waving of the hair You may also note that there is accompanying burnt hair smell 8 3 5 Treatment periods General treatment each time interval is 3 to 6 weeks Page 40 User s Manual 8 3 7 Side effect Erythema and discomfort after treatment is treated with cold packs until the discomfort subsides Erythema normally subsides over a few hours for lighter individuals and may take longer for darker skinned individuals Blisters normally dries up after a few days and the scab generally falls off in 1 to 2 weeks An antibiotic ointment can be applied to prevent infection and to hasten healing Post inflammatory pigmentation can be treated with topical retinoids 8 3 8 Post Treatment Care Apply cool packs after treatment of each area before moving on to the next treatment area For persistent erythema mid potent topical steroids can be applied For areas of blister formation an antibiotic ointment can be prescribed Post treatment it is recommended not to shave and not to apply deodorants for the 15 24 to 48 hours It is strongly advised to avoid sun exposure and to use a sun block 8 3 9 Follow up Consultation Follow up consultation is highly recommended specially when post treatment complications such as blister forma
35. nt hair removal RUIPU BEAUTY Chapter 2 Safety 2 1 Introduction This chapter describes the proper use of the IPL Photorejuvenation treatment systems Each operator must have read and understood the User s Manual completely prior to starting the Device 2 2 Responsibilities of the User NX WARNING This device may cause thermal injury if used improperly Medical personnel must familiarize themselves with the devices safety instructions and operational procedures prior to use Before each treatment the user must check the functional performance of the device in order to rule out any risk to patients or third parties if the device is used in conjunction with peripheral units the User s Manuals for the peripheral units must also have been thoroughly read and understood 2 2 1 Safety Measure The IPL is designed to prioritize the safety of the patient and medical personnel The following are its parts of safety measures A Upon switching on the system the processor first undergoes a self diagnostic program The processor will then examine the system automatically and continuously during the entire treatment procedure B Use the Emergency Cut off Switch red button to turn the power off in case of an emergency C Remove the Key when not in use to prevent unauthorized access to the device 2 2 2 Safety warning Only personnel trained by the distributor are authorized to maintain the inner workings of this device Any manip
36. nt parameter chart for the treatment intervals 7 8 5 Adverse Reactions If at any point of treatment an adverse reaction is noted hold treatment apply a cold compress and review your parameter setting The cold compress may be needed for 5 to 10 minutes or until the adverse reaction is remedied Some common reactions are 1 erythema this usually lasts for half and hour or so This is specially noted during skin photorejuvenation 2 Residual Warmth Stinging sensation apply cold compresses for 10 15 minutes or until symptoms are alleviated 3 Increase in pigmentation of lesions in pigment reduction treatment this is expected and normally the lesion will dry up and peel off in a few days It is recommended that an antibiotic ointment be applied 4 In rare events Blister formation can occur especially when the wrong treatment parameter is used i e wrong skin type or high fluence Apply compresses to dry the blister followed by regular application of an antibiotic ointment 7 9 The advantage of the IPL treatment Non ablative Non painful Simple and quick treatment No down time post treatment BON Page 36 User s Manual Chapter 8 Parameters selection 8 1 Treatment of Pigmented Lesions 8 1 1 Treatment princlPLe Light absorbed by melanin is transformed into heat energy This process causes the breakdown of pigment molecules and is cleaned and by phagocytes and are also shed off by the normal process skin renewal T
37. nt systems 1 Control panel 2 IPL Treatment handpiece 3 Main unit 3 1 1 Main unit The Main unit is the integral part of this system it consists of the following parts 1 The Power supply module regulates electrical supply to the entire system 2 The Control module Regulates and coordinates the various components of the system for optimum performance 3 The display module Displays various information of the system and accept users instruction 4 High current capacitors Delivers adequate electrical energy to guarantee sufficient power during operation 5 Cooling system Maintains a stable thermal environment for optimum performance CAUTION Only engineers certified by FP are authorized to service and maintain this device 13 3 1 2 Control panel Operation of this device is done through the control panel It includes the following parts Key switch Used to turn on and off the power supply clockwise to turn on and counter clockwise to turn off Emergency turn off switch The red button found in the front panel of the device is used to immediately shut off the device s power supply in case of any emergency Depressing this button will cut off the power supply to the whole system Rotating the button in the direction of the arrow printed on its surface will disengage the button and will reengage the power supply When this button is engaged remember to turn the key switch to the off position afterwards The Liquid
38. ntation 1 Pre and postoperative photographic documentation is desired if possible 2 Please make sure that the camera settings lighting and distance is kept uniform 7 5 Untoward Reactions 7 5 1 Pain The Xenon flash lamp produces an intense beam of light that generates heat and is precisely modulated by computers and filters The use of the built in cooling semiconductor as well as the application of cool coupling gel diminishes discomfort during treatment The sensation of this heat is compared to that of being flicked with a rubber band Any residual sensation post treatment is kept to a minimum by applying cold packs left on for 5 to 10 minutes Page 32 User s Manual 7 5 2 Scab formation Scab formation after treatment can occur particularly if 1 a greater than amount of power fluence has been used 2 For the treatment of pigmented lesions sometimes the only way to treat pigmentation is to physically destroy the pigment containing structures By doing so vesicle formation and scab formation is expected It is advised to place cool packs after treatment and to apply an antibiotic ointment over the treated area until the scab has fallen off 7 5 3 Pigmentation change Post treatment darkening of target lesions can occur This is particularly expected for the treatment of pigmented lesions In a few days to weeks the scab will fall off 7 5 4 Scar formation Scar formation is not an expected side effect 7 5 5 Swe
39. ower cable 1pc Foot switch 1pc O Ring for faucet 1bag Key 2pcs Consumable 14 3 2 1 Filter Standard Spectra Application areas 560 1200nm vascular pigment Photo rejuvenation 640 1200nm hair removal 690 1200nm hair removal 3 2 2 Protection glasses One pair of protective glasses are provided with the device The opaque glasses are to be worn by the patient and the filtered 200 1400 nm glasses are to be worn by the operator Despite wearing the protective glasses avoid staring directly into the intense pulses of light during the treatment Only personnel wearing protective glasses may be allowed to observe the treatment 3 2 3 Light coupling gel The light coupling gel is used to maximize the conduction of light from the flash lamp to the skin The light coupling gel must be clear transparent and not colored tinted Colored gels absorb light therefore reducing the effectiveness of the treatment The light coupling gel must be chilled but not frozen Frozen gel diffuses the light emitted by the flash lamp reducing its efficacy Light coupling gels must be non alcohol based The IPL produces considerable heat flammable material must be kept clear of the treatment area 3 2 4 Order accessories A complete set of accessories is included with this device when delivered Additional accessories may be ordered through your authorized distributor This device is very sensitive Accessories and spare parts not p
40. ransient erythema and darkening of pigment molecules can be expected 8 1 2 Available Filters gt GSD 801E Multi filtered units 510nm 1200nm 560nm 1200nm filter 8 1 3 Basis of Parameter Selection 8 1 3 1 Skin color gt The darker the skin the longer the Pulse Width T1 T2 8 T3 and lower the fluence gt The lighter the skin the shorter the Pulse Width T1 T2 amp T3 and greater the fluence 8 1 3 2 Skin sensitivity gt The more sensitive the skin the lower the fluence 8 1 3 3 Color of target lesion gt The darker the lesion the longer the pulse delay D1 amp D2 to allow more cooling between pulses gt The lighter the lesion the shorter the pulse delay D1 amp D2 8 1 3 4 Depth of Target lesion gt The deeper the lesion the greater the number of pulses gt The deeper the lesion more longer the pulse delay 8 1 4 Parameters selection Start with a low fluence i e 25 J cm Do a test shot in an inconspicuous area Evaluate patient response then gradually increase the fluence by increments of 3 J cm when a fluence of around 30 J cm is achieved increase by increments of 1 or 2 depending on patient s response 8 1 5 Treatment Evaluation During treatment of pigmented lesions note that the target lesions will normally turn whitish gray and normally darkens a few hours after treatment The surrounding skin will normally turn erythematous It should also noted that treatment of pigmented lesions produces more discom
41. rly or ignoring them completely can endanger patients and or operators CAUTION Attention means that not following instructions properly or ignoring them completely can damage the unit NOTE Notes provide additional information VAN NOTE Read the user s manual prior to operation Chapter 1 Preface 1 1 Overview Intense pulsed light IPL is a type of intensive broadband coherent light source which has a wavelength spectrum of 420 nm 1200 nm With these special properties the IPL has a wide application in non ablative therapies based on theory of human skin tissue s selective absorption and photothermolysis of light sources Meanwhile IPL treatment is more effective with no downtime and can make the patients get recovered more quickly than conventional therapies 1 2 Device brief introduction Model name GSD 801E Product name IPL Photorejuvenation treatment systems Figure 1 1 shows the device Figure1 1 GSD 801E IPL Photorejuvenation treatment systems 1 3 Device structure This device is composed of three parts 1 main unit 2 control panel 3 the IPL treatment handpiece The control panel includes the color 8 4 TFT LCD touch screen the power switch and emergency shut off switch The LCD screen shows the work mode and the parameters of the system 1 4 Medical Use Application Areas 1 Therapy acne 2 Reduction of vascular lesions 3 Reduction of pigmented lesions 4 Skin rejuvenation 5 Permane
42. rovided by your authorized distributor must never be used with this device Doing so will void your warranty 15 3 3 System software The software of the IPL mainly has four functions 1 Allow the doctor to choose the best characteristic parameters for the patients according to the concrete diagnosis 2 Control the working process of the system in order to prevent unexpected trouble 3 Examine the system energy 4 Choose the treatment ranges 3 4 The environment requirements Working temperature scope 15 30 C Relative humidity scope 30 80 Atmospheric pressure barometric 86kpa 106kpa The store environment temperature 5 C 55 C Power supply 220V AC 50 60Hz lt 10A or 110V AC 50 60Hz lt 20A Page 16 Chapter 4 Installation The process of installation includes Performed by an authorized technician only 1 2 DAR Unpacking the device Staying the device for one day in order to avoid destruction by high humidity during long distant transportation Assembly of its components and ensure that all connections are firmly in place Fill the water tank with distilled water only Connect the power supply Switch on the device and test all functions parameters of the system 4 1 Equipments detailed list The following is the detailed list of equipments of this device YVNNNNNNNNNN V Main host The IPL treatment handpiece Cradle of handpiece Protective glasses Protective goggles Power
43. tion are noted Follow up treatment is only scheduled when adverse effects have been resolved Please see attached follow up treatment schedule in the treatment parameter chart attached 8 4 PHOTOREJUVENATION amp DEEP SCARS 8 4 1 Treatment PrinclPLe Collagen effectively absorbs the 560 nm 1200 nm spectrum of light This results selective thermolysis of collagen resulting in heating and contraction of collagen bundles The retraction of collagen bundles makes this process effective in the management of fine superficial wrinkles 8 4 2 Available Filters gt GSD 801E Multi filtered units 560nm 1200nm filter 8 4 3 Parameter Selection You may request the ref treatment parameter sheet from apolo authorize territory distributors Page 41 User s Manual Start with a low fluence i e 25 J cm Do a test shot in an inconspicuous area Evaluate patient response then gradually increase the fluence by increments of 3 4 J cm when a fluence of around 30 J cm is achieved increase by increments of 1 or 2 depending on patient s response We strongly recommend that for the 1st treatment the fluency level be set initially at least 8 to 10 joules sq cm below the suggested level of treatment parameter sheet Please note that treatment over bony areas such as the malar area forehead and shins produces more discomfort so reduce the fluence by 2 3 joules When treating very densely pigmented areas reduce fluence by 2 3 joules 8 4 4 Tr
44. ulation to the system may cause damage to the device and will void its warranty 2 3 User Training N WARNING The intense light delivered by this device may cause serious injury If handled improperly All personnel using this device must remain vigilant and utilize safety protocols The IPL Photorejuvenation treatment systems require special expertise and care in its handling and use Only persons who have received appropriate handling training on the device taking into consideration operating instructions and who are familiar with its therapeutic effect and possible risks are permitted to use the laser unit Untrained or unqualified operating personnel are not permitted to operate the IPL Photorejuvenation treatment systems under any circumstances whatsoever FP Medical Technology Co Ltd offers comprehensive training courses for the IPL Photorejuvenation treatment systems to authorize territory distributors Each user must have read and understood the User s Manual completely prior to starting the IPL Photorejuvenation treatment systems Patient s safety mainly depends upon a well trained operators and a suitable treatment room The attending operators must inform the patient all inherent risks with the use of this device The success of the treatment depends largely on the user s experience and knowledge of the biophysical connections 2 4 Explanation to Patients The treatment process must be explained to the patient The patient m
45. uld be as little as possible or it can absorb the energy of light and be heated up When the dust falls on the surface of the filter it may damage the filter Metal particles also could damage the electric component Temperature The IPL system has an optimal working temperature between 15 C 30 C Relative humidity should not be over 80 The working power of this device is about 2 KW It is best that the IPL unit be installed in an air conditioned room where the relative humidity and temperature can be maintained at optimal levels Page 18 User s Manual 4 3 Installation 1 The device should be placed in a room with an indoor temperature of 15 30 C the humidity should not be higher than 80 Operating or treatment rooms must be kept clean of all times 2 Turn on the Infusion drain tap and unscrew the ventilation screw caps According to the following figure O Figure 4 1 Figure 4 2 3 Infuse distilled water until the water level reaches 90 level way of the water observation window Drain and infusion water tap O Figure 4 3 4 Ensure that the key is in the off position and that the emergency cut off button is not engaged If it is engaged release it by rotating the button towards the direction of the arrow indicator 5 Attach the power cord and attach the foot switch cord 6 Switch the circuit breaker to the On position 7 Switch the unit on by inserting the key and turning it in a
46. ust give written consent to the treatment 2 5 Optical safety All personnel including the patient should wear the protective glasses opaque eye shield for the patient and filtered 200 nm 1400 nm for the operators The goggles glasses provided with this unit are manufactured specifically for the 400 nm to 1200 nm wavelength produced by the IPL unit Do not substitute treatment safety glasses with other types of tinted eyewear which may not meet the specific safety requirements of the unit Note Gauze eye shield and tarsi are all effective in the protection for the eyes 2 5 1 Intense light warning The intense light may damage the eyes Please observe caution at all times Avoid looking directly into the sapphire crystal during operation even if wearing the protective goggles When not in use keep the treatment handle on its carriage and keep the device on standby or simmer mode 2 5 2 Treatment Room The treatment room should be clearly marked to prevent unnecessary access by other personal during the procedure 2 6 Electrical and machine safety The unit uses 220V 50 60Hz 110V 50 60Hz single phase power supply Its capability should be no less than 2000W Use a lt 10A 220V 50 60Hz 12A 110V 50 60HZ single phase three wire outlet at an international level A high level of energy is generated by the unit when in use The maximum charged volts of energy stored in the capacitor is 450V When the unit is switched off the max
47. y into the intense light during the treatment even if you are wearing the protection glasses Do not point the treatment head outside the treatment field a TAG o 5 1 Software operation explanation 1 Main menu Page 22 User s Manual Figure 5 1 Turn the unit on by turning the key switch in a clockwise direction The screen will show the main menu and will undergo a systems check up diagnostic program See figure5 1 After select any one of language by touch of screen the program will then enter the Treatment Mode Selection Menu 2 Treatment Mode Selection Menu amp Parameter setting Menu see Figure 5 2 Treatment mode Treatment Mode Window shows the current treatment mode Energy output window displays current energy output setting Treatment parameters shows the current accepted treatment parameters System Information window shows the available control options Any warnings or system errors are displayed here The Treatment counter displays the total number of shots by the specific treatment hand piece total number of shots for thi ific treatment Parameter setting 34014 IC CARD ON LINE pack Figure 5 2 Page 23 User s Manual 3 Treatment Mode Selection e Once in the Treatment Modes Selection Menu touch one of Treatment Mode between PIGMENT HAIR REDUCTION BREAST REJUV modes on the screen to make a selection of your treatment Once in the selected treatment menu
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