Alba 355
Contents
1. El GGE ITAI E Ur ICAA G A be edi EVLASER MEDICAL DIVISION Laser Device MEDICAL DEVICE USE R S MA N UAL ate AZ 02 12 Jf y Package contenta iba 3 PRESENTATION sutil 5 Generalindieation sara rosa iaa oa 5 EGURREAN EAEEREN EAEAN RER EERUARN 5 ME gia dde zb e an s 5 HOWto commana Aiegi dea SUA 5 Eda AOZ A E 6 Satetv inteeration prineiplessnis een ei 6 SARETI IV OLS nn A oe 6 Electromagnetic Mmterterentes asi aa 6 J DESCRIPTION is ic 7 Genera ION Oli EEE 1 Ra ara E aea aea be aea bee 1 B de STA 8 Rear Vie REE ee ee er eia 9 GeneralCcOntrols panela canas 10 CONTO PAN ura dida 11 Telescopio MM di tai 12 Source Group laserscanning head au un a ua 14 4 POSITIONING AND STARTING UP au 2 16 Positionme procequre and Start UD aria ada ee ee ee 16 ete ING TIN Se see ee ee ias 16 oiala NA 23 6 THE EGAN GA NEAN 25 Preparation OF tne patenta eds 25 siz aera iga EAEE 25 MI cumin 25 FVUSINOPRROLOCO ihe meen eee tert ne ee E at ween ne nee TE Tenet me ween nea 2 Mia AAA o re ere PST nnn RR Pe nee ee 21 UVAT Section mechani M dre 21 Uta die i deialdia BAA 21 Climcahindicat ON Sit 28 Protocol resuming ta blend 29 a a AAA 30 8 CLEANING DISIN EFECTO N EAEE 31 9EIMAINTENANEE tt A ee 31 Appendix 1 Technical description Appendix 2 Labelling ALBA 355 user s manual Rev 1 0 4 2012 2 Package content This package contains following items Laser device Protection glasses Pen for touch screen2. 5 O E o 2 GO d al dd WARNING IN THE EVENT OF EMERGENCY PRESS THE RED BUTTON ON THE FRONT OF THE EQUIPMENT ALBA 355 user s manual Rev LO 4 2012 17 If at the switch on the following screenshot appears verify the key switch of the laser power is on For a description of the anomalies refer to paragraph anomalies l 50 14 BO 6 e By pressing on the control panel select the desired shape of the scanning laser using the Selection form mask The shapes available are round or square e Manually dimension the selected form using the scroll bars dimensions in millimeters are displayed in boxes on the side of the scroll bars ALBA 355 user s manual Rev 1 0_4 2012 18 e Select the scan speed through the mask Speed mm s by pressing the desired value e Select Fluence from the mask Total Requested Fluence using the arrow keys to decrease N to increase the value in steps of 10J cm from a minimum of 20J cm to a maximum of 250J cm 2 Pressing on the numeric value indicated in the mask a numeric keypad will appear giving the possibility to directly set this value 90 e Press the Preview to see directly on the patient through the red laser pointer the treatment area that has shape and size characteristics as previously selected It s possible to disable the preview by pressing the button again the active state is highlighted by the word Preview On a
3. place electromagnetic conditions shall not be different from the parameters set out in the tables in Annex 1 to this manual ALBA 355 user s manual Rev 1 0_4 2012 6 3 DESCRIPTION ALBA 355 unit is a high technology equipment for therapeutic applications in aesthetic medicine This manual which must be carefully read describes the device functionality and controls important information regarding maintenance and indications relevant for a safe use General information This manual refers to the device ALBA 355 This manual contains a description of the controls of the device information important for the maintenance and indications relevant for a safe use It is recommended that all future users of ALBA 355 read carefully the entire manual before starting any treatment This is an homologated device that uses a class IV laser it is used for the treatment of lesions of the epidermal differentiation The laser The laser system consists of a Neodymium source YVO4 pumping diode The power laser beam visible through the pointing beam is transmitted to the treated part by a scanning head The scan head is the transportation mean of YVO4 laser energy from the source to the treated area and allows to concentrate the energy in one place The point in which the laser energy is concentrated is called the spot The spot diameter is adjustable The laser power YVO4 is pulsed has a wavelength of 355 nm UVA and has features adjustable by
4. stand by and you will see an alarm on the screen Once the anomaly is solved the alarm disappears and you can go on working normally You can see all possible alarms in the dedicated screenshot Alarms which shows a list of Alarms next to a red or green dot according to the state it is red when alarm is active green if not active ALARM CODE DESCRIPTION SOLUTION 1 2 Cooling system Verify that the grids of the cooling fans placed on the external structure of the machine are free Contact Service Shutter Contact Service Laser power supply Contact Service Laser controller Verify that key switch is ON Contact Service Alarm Stage RF driver Temperature Within the laser section there is a modulator stage commanding the operation of the laser source In case of malfunction of the modulator and or when an abnormal temperature is reached different from the temperature range set by the manufacturer the system goes in to alarm The active alarm automatically switches the device to stand by mode The laser emission is possible only when the alarm is not active ALBA 355 user s manual Rev 1 0 _4 2012 23 Alarm Cooling system During normal operation the system ALBA 355 is constantly cooled by an autonomous internal refrigeration system The refrigeration system is continuously monitored by suitable sensors If for any reason the temperature deviates from the parameters set by the manufacturer the alarm is displaye
5. the operator The laser pointing instead is not adjustable and has a wavelength of 635 nm visible Functioning Laser is the acronym for Light Amplification by Stimulated Emission of Radiation The generated laser beams power beam and pointing beam present in the laser system are harmful to the eyesight especially if pointed directly to the eyes For the use of ALBA 355 the laser beam Nd YVO4 is concentrated on the patient in a focal point so it is always necessary to protect yourself with the glasses provided and to avoid anyway to direct the handpiece to the eyes Controls panel The controls panel touch screen graphic display placed in front of the unit contains all the controls and information the operator needs to adjust the operating parameters The controls panel consists of a colour monitor which includes a touch screen functionality This control visualization system make s available all controls necessary to manage device functionalities To manage the functions of the device you just have to press the buttons on the control panel see picture 1 ALBA 355 user s manual Rev 1 0 4 2012 7 Front view 6 5 4 3 2 1 Picture 1 Device description front Legend 1 Castor 2 Castor brake 3 General controls panels 4 Control panel 5 Telescopic column 6 Laser source 7 Laser scan head ALBA 355 user s manual Rev 1 0 4 2012 8 Rear view e N WW E Picture 2 Device description rear Legend Electri
6. Laser emission When active it indicates the laser output from the scanning head White warning light Laser ready It indicates the laser is ready for emission after turning on the key on the general controls panel ALBA 355 user s manual Rev LO 4 2012 11 Telescopic column Picture 5 Telescopic column Legend 1 Locking knob 2 Telescopic column Locking Knob The locking knob is used during the installation phase of the equipment for the positioning of the source group laser scanning head allowing to block it in the working position To allow the movement slightly loosen the locking knob place the source block scanning head and then close the locking knob The allowed movement is 90 as shown in the following picture ALBA 355 user s manual Rev LO 4 2012 12 Picture 6 Source group movement head Telescopic column Allows handling on vertical axis of the source group scanning head through the manipulation of the up down selector placed on the general control panel The movement of the column is necessary in order to obtain the correct focal distance between the laser output of the scanning head and the patient Normally the focal length is 300mm EO WARNING THE TELESCOPIC COLUMN IS A BODY IN MOTION AND AS SUCH REQUIRES MAXIMUM CAUTION DURING HANDLING SPECIAL ATTENTION MUST BE GIVEN TO THE DANGER OF CRASHING e BETWEEN THE LASER SOURCE AND THE TOP OF THE MACHINE FOR THE USER e BETWEEN THE LASE
7. R SOURCE AND SCANNING HEAD FOR THE PATIENT A WARNING DO NOT EXERCISE MECHANICAL STRESS ON THE SOURCE GROUP HEAD THROUGH MANUAL ACTION PRESSURE TRACTION HANGING OR PUTTING WEIGHTS A WARNING AVOID ANY CONTACT WITH THE INNER TERMINAL PART OF THE SOURCE GROUP ALBA 355 user s manual Rev 1 0 4 2012 13 Source Group laser scanning head Picture 7 Scanning head group Legend 3 Laser Source 4 Laser scanning head Laser Source Section containing the components for the generation of the laser beam Laser scanning head Connected directly to the laser source concentrates and moves the laser beam on the patient A WARNING EXERCISE EXTREME CAUTION WHEN HANDLING THE SOURCE GROUP LASER SCANNING HEAD AVOID DIRECT AND INDIRECT IMPACTS TO AVOID DAMAGE FAILURE OF LASER DEVICES A WARNING IT S FORBIDDEN TO OPEN THE PROTECTIONS ON THE LASER SOURCE AND ON THE LASER SCANNING HEAD ALBA 355 user s manual Rev 1 0 4 2012 14 Picture 8 scanning laser head movement Legend 1 Movement handle 2 Laser exit 3 Movement handle Movement Handles Through the movement handles it is possible to adjust the position inclination rotation of the scanning head in order to properly address the laser beam over the treatment area of the patient Laser exit Laser beam exit point A NEVER POINT THE LASER BEAM COMING OUT FROM THE SCANNING HEAD IN THE DIRECTION OF EYES OF PEOPLE OR ANIMALS AND FLAMMABLE OR
8. REFLECTIVE SURFACES IT IS COMPULSORY FOR THE OPERATOR AND THE PATIENT THE USE OF SAFETY GOGGLES PROVIDED E asomo EXERCISE EXTREME CAUTION WHEN HANDLING THE SCANNING HEAD DUE TO CRASHING DANGER FOR THE PATIENT ALBA 355 user s manual Rev 1 0 4 2012 15 4 POSITIONING AND STARTING UP Positioning procedure and start up The forecast installation site is hospital or a doctor s studio ALBA 355 must be positioned on a flat surface that allows secure placement of the equipment Verify that the site conditions comply with those indicated in the tables e TECHNICAL CHARACTERISTICS e EMC ENVIRONMENTY CHARACTERISTICS of Annex 1 ALBA 355 user s manual Rev 1 0 4 2012 16 5 FUNCTIONING Refer to the following procedures for proper use of equipment e Read this entire instruction manual and ascertain that the installation was correctly performed e Check that all persons within the site where the equipment is installed wear safety goggles e Verify that the switch on the back of the machine is in position O then connect the power cord to the mains supply e Place the main power switch on the back of the machine in position e Turn the ignition key to start the power section of the laser the light of white color Laser Ready placed on the front of the machine indicates the laser ready status Simultaneously the control panel will activate and at the end of management software loading the following screenshot will be displayed
9. al improvement accompanies the increase of the number of leucocytes and the reduction of antibodies anti nucleus and anti ENA The therapeutic action is most likely obtained by the induction of apoptosis of T lymphoid cells infiltrating the skin and in Keratinocytes by the promotion of DNA reparation by the interference and translocation of nuclear soluble antigens non histone like the SSA Ro and by the reduction of IL 12 levels Scleroderma High dosed of UVA1 have been successfully used in the therapy of morphea both in adults and in children in acrosclerosis and cutaneous effects of systemic sclerosis Lesions show reduction of the derma thickness with reduction of collagen fibers and an increase of elastic fibers The therapeutic action can be referred both to the reduction of the number of T lymphoid cells infiltrating the plaques and to the increase of collagen activity of the fibroblasts ALBA 355 user s manual Rev 1 0 4 2012 28 Psoriasis In skin treated with psoralenes the maximum photo toxic and anti psoriasic activity is obtained with wavelengths included between 320 and 330 nm Two types of UVA sources are widely used for PUVA therapy Fluorescent UVA lamps emission pick is 352nm and emit about 0 5 in the UVB band The emission of filtrated halogen metallic lamps contains more UVA1 and UVB 1 5 3 0 higher irradiance and a better space homogeneity of the emission In the light of what written in literature we wanted t
10. c socket Fuses Footswitch socket Interlock Fans U AeA UNBE ALBA 355 user s manual Rev 1 0_4 2012 9 General controls panel Picture 3 General control panel Legend 1 Key switch to activate the laser power supply 2 Emergency button 3 Telescopic column movement selector Key switch to activate the laser power supply Allows to start the power feeding section of the laser source Emergency button To use only in case of emergency If pushed it interrupts immediately the power sections of the machine Selector up down Selector used to move the telescopic column it is usually in central position neutral Turning clockwise up the telescopic column will extend while turning counter clockwise down the column will retract The selection will be kept until you keep the selector turned If you leave the selector it will go back to its original position autonomously and will interrupt the movement of the telescopic column ALBA 355 user s manual Rev 1 0_4 2012 10 Control panel Picture 4 Control panel Legend Touch screen monitor USB connector for service Red warning light to indicate laser emission White warning light to indicate the laser is ready BR WN bek Touch screen monitor Through this you can manage all using parameters by selecting with a touch the requested options and parameters USB socket for service This socket is reserved solely to assistance staff Red warning light
11. d automatically switching the unit to stand by mode The laser emission is possible only when the alarm is not active Alarm Shutter Within the source of ALBA 355 there is an electromechanical device able to avoid accidental laser emission This safety device is called Shutter The alarm is displayed when the shutter safety device is not working properly The active alarm causes the automatic switching of the apparatus to stand by mode The laser emission is possible only when the alarm is not active Alarm Power supply The unit contains a power supply system of the laser source The power supply is enabled every time the ignition key on the front panel of the device is turned ON and is disabled by placing the key in the OFF position In good working conditions the power feeder switches on after 30 seconds about If after placing the key in the ON position the power feeder is not on there is a fault and the alarm is displayed The active alarm causes the automatic switching of the apparatus to stand by mode The laser emission is possible only when the alarm is not active Alarm Laser controller The unit contains a laser controller system of the source The laser controller is enabled every time is enabled every time the ignition key on the front panel of the device is turned ON and is disabled by placing the key in the OFF position If after placing the key in the ON position the laser controller is not on there is a
12. essary to clean the screen using a micro fiber cloth so that controls are always visible ote WARNING BEFORE DOING ANY MAINTENACE OPERATION DISCONNECT THE EQUIPMENT FROM THE ELECTRIC FEEDING 9 MAINTENANCE eis WARNING ANY ELECTRONIC MECHANIC OR ELECTRIC OPERATION MUST BE DONE BY AUTORISED AND SPECIALISED PERSONNEL E wy JK WARNING BEFORE DOING ANY MAINTENACE OPERATION DISCONNECT THE EQUIPMENT FROM THE ELECTRIC FEEDING There is no maintenance by the user except for cleaning and disinfection as described in paragraph 8 above it is responsibility of the operator or organization responsible the periodic review of The general integrity of the unit the integrity and readability of labels and markings applied to the unit Integrity status of the feeding cable In case of any signal of malfunctioning like excessive heating strange noises etc Stop working immediately Call the assistance service The following maintencance operations are expected to be done periodically every 12 months by the technical assistance staff e Power control calibration e Power control e Calibrations control e General control of electrical electronic and mechanic components In some countries regulations state specific checks on electrical equipment every two years these must always be done by the technical assistance of the manufacturer ALBA 355 user s manual Rev LO 4 2012 31
13. f ICAM 1 5 Unlike UVB and UVA2 UVA1 can induce the apoptosis of lymphoid cells T in particular T helper non only through delayed mechanisms which depend on a synthesis de novo of some proteins but even through precocious mechanisms pre programmed and independent from protein synthesis UVA1 provokes the production of PGE2 and thromboxanes in the Langerhans cells but doesn t affect their number and functionalities and does not induce their migration into satellite lymph nodes Finally UVA1 can affect the activity of fibroblasts with increase of the synthesis of collagenases 1 and a reworking on the stroma with an increase in the urinary excretion of the waste products of collagen and Ill Therapy protocols The protocols for the photo therapy UVA1 entail the irradiation of low 6 5 20J cm2 medium 40 60J cm2 or high dosages 100 130J cm2 with no need to increase dosages during the therapy Cumulative doses for low dosages are estimated lower than 300J cm2 those for medium dosages are included between 300 and 975J cm2 and for high dosages between 975 and 1840J cm2 1 2 3 4 Usually non coherent UVA1 emitters have lighting radiations in a spectrum included between 340 and 400nm but sometimes we can find radiations higher than 530nm and other infrared radiations have been isolated 780 300 nm With monochromatic radiation the wavelength of UVA1 is 355nm ALBA 355 user s manual Rev 1 0 4 2012 27 Clinical indications A
14. fault and the alarm is displayed The active alarm causes the automatic switching of the apparatus in stand by mode The laser emission is possible only when the alarm is not active ALBA 355 user s manual Rev 1 0 4 2012 24 6 THE TREATMENT The use of ALBA 355 for the treatment of diseases must be evaluated carefully by the doctor who must determine adequacy of treatment and working parameters see section 7 to better understand the mechanism of action read the information written below Preparation of the patient The patient must be given protective goggles UV 355nm which are supplied with the machine then take a seat as per the normal treatment sessions The treatment During the use of a laser you must adopt the normal procedure controls of the treatment The operator must periodically check the progress of treatment During the treatment the first thing to remember is to maintain the scanning head of the laser at the correct focal distance and as much as possible perpendicular to the surface to be treated Then press the footswitch to activate the laser Nd YVO4 Pay attention to the position and to derma conditions Like traditional procedures the control of the results of the treatment is performed without is by visual inspection Warnings Skin exposure to laser The exposure of the skin in some cases may generate a small edema In order to avoid this drawback the laser scanning head must be maintained perpendicular to t
15. ffects are rare and limited to the occasional appearance of a modest and reversible xerosis with pruritus and possible intensification of a pre existing photo dermatosis We didn t observe long term side effects on men but studies on murine models do not permit to exclude potential carcinogen and an action promoting photo ageing Visible laser beam In unit ALBA 355 the invisible Nd YVO4 beam is parallel to a visible solid status beam This one red is used to ensure the operator points the scanning head on the right area to treat The beam must be as much as possible perpendicular to the surface to treat In case you cannot see the laser beam after pressing START or its intensity is reduced there could be damage due to an improper use of the laser or of the scanning head ALBA 355 user s manual Rev LO 4 2012 30 8 CLEANING DISINFECTION Wipe the unit Periodically with a soft sponge soaked with a solution of mild soap Avoid creating streams that can penetrate inside the machine Dry with a soft cloth Clean the cord taking care to dry all the plugs and connectors When not used store the device in a dry dust free place not outside During periods of long disuse keep the machine disconnected from the power Do not put any heavy equipment or liquids above the machine To work properly over the years an annual review is needed It a good idea to clean the handpiece using solutions for local antisepsis type Barrycidal It is also nec
16. he surface to treat You should also use the minimum energy since using too much energy increases the possibility of generating excessive heat on the skin Patient s reaction If a patient feels pain during the treatment one possible cause is the accumulation of heat generated by the irradiation This heat spreads to the nerve endings and may damage them even irreversibly In this case the operator should pause the treatment and cool down the area If restarting the treatment the patient feels pain again you will need to stop the treatment Precautions If the patient suffers from one of the following malfunctions and takes specific medicines he must inform the operator prior to any intervention Allergies Arthritis Asthma Depression Diabetes Epilepsy Immunodeficiency Hypertension Hyperthyroidism Heart diseases We advise you to avoid any kind of treatment during pregnancy not because harmful to the fetus but for the particular hormonal status of women during gestation Aim The emissions generated for the treatment interact with the tissues that make up the derma Part of the emission however is reflected from the surface of the derma therefore the most efficient mode of application is the one through where light power hits the tissue with an angle of about 90 ALBA 355 user s manual Rev LO 4 2012 25 Patient movement In order to prevent irradiation of tissues different from the ones to treat the patient must stay as much sti
17. is manual has been designed and produced to be safe each device is tested to verify conformity to EN 60601 1 standard for medical devices or the equivalent local standard Elettronica Valseriana is not responsible for any damage to persons or objects caused by improper use of the product or by failure to follow safety directions These devices can be operated solely by trained and qualified personnel aware of potential dangers This applies also for maintenance activities which must be carried out only by highly qualified technicians authorized by the manufacturer To use ALBA 355 follow the instructions illustrated in this manual which must be carefully read and be always available to the operator Any use different from what shown in this manual is not recommended as it can be dangerous to persons and objects We suggest you always contact Elettronica Valseriana for explanations or additional information bua JK WARNING TO AVOID ELECTRICAL HAZARD THESE EQUIPMENT MUST ALWAYS BE CONNECTED TO MAINS EQUIPPED WITH PROTECTIVE EARTHING ala WARNING DO NOT REMOVE SKIP OR MODIFY ANY COVERING OR SAFETY DEVICE ANY CLEANING REGULATION REPAIR OR LUBRICATION MUST BE CARRIED OUT WHEN THE EQUIPMENT HAS BEEN DISCONNECTED FROM MAINS FOR AT LEAST 10 MINUTES SAFETY SYMBOLS Follow use instruction CEI EN 60601 1 Applied Part BF CEI EN 60601 1 Protection ground wire CEI EN 60601 1 Electromagnetic Interferences The installation
18. ll as possible Energy used During treatments always use the minimum energy so to reduce the risk of damages to the treated areas Procedures The unit ALBA 355 is indicated for the treatment of lesions due to the epidermal differentiation on most of the human body To avoid that the emission reaches the retina while passing through the tissues it is recommended not to treat areas near the eyes ea WARNING THE CONTINUE REPETITION OF LASER PULSES IN ONE AREA MAY BURN THE PATIENT EO WARNING MOVEMENTS OF THE PATIENT MUST NOT COMPROMISE THE SAFETY OF THE TREATMENT IF YOU CANNOT DO THE TREATMENT SAFELY INTERRUPT IMMEDIATELY N WARNING START LASER EMISSION ONLY WHEN THE SCANNING HEAD OF THE LASER IS DIRECTED TOWARDS THE AREA TO TREAT N WARNING NEVER POINT THE LASER SCANNING HEAD TOWARDS THE EYES OF PEOPLE OR ANIMALS OR TOWARDS FLAMMABLE OR REFLECTIVE SURFACES THE OPERATOR AND THE PATIENT MUST USE THE GOOGGLES SUPPLIED WITH THE DEVICE EO WARNING THE INTENSITY OF THE POWER USED DURING A TREATMENT CHANGES FROM A SURFACE TO ANOTHER EACH TREATMENT MUST START WITH THE MINIMUM ENERGY INCREASE THE INTENSITY OF POWER APPLIED TO SURFACE SUBJECT TO TREATMENT ONLY IF IT IS STRICTLY NECESSARY ALBA 355 user s manual Rev LO 4 2012 26 7 USING PROTOCOLS Introduction Artificial rays UVA such as sunbeds lamps solar panels are used both in the beauty and medical field obviously for different applications Besides broadband e
19. mission narrowband UVA has recently been introduced in the market UVB 311 nm band TLO1 UVA2 320 340 nm and UVA1 340 400nm These wavelengths allow to get therapeutic advantages in the treatment of psoriasis vitiligo UVB 311nm and atopic dermatitis UVA1 Further to these pathologies where results are consolidated selected band phototherapy is being studied for other types of dermatosis In principle an evaluation of the quantity of energy deliverable on the skin lets us identify an initial dose of 0 2 0 4 J cm2 UVB narrowband and 1 2 1 5 J cm2 for UVA or UVA1 UVA1 action mechanism Unlike UVB and UVA2 315 340nm the biological effects of UVA1 are obtained through aerobic photo oxidation reactions with the intermediate formation of reactive species of oxygen such as singlet oxygen superoxide anion and hydroxyl radicals The anaerobic formation of photo products between tymines is completely unimportant In Caucasians about the 37 of emitted UVA1 penetrates the skin until 60 90 um therefore these wavelengths can effectively modulate the immunological and inflammatory activities of cellular populations resident not only in the epidermis but also in the derma On Keratinocytes UVA1 induces the synthesis and the release of IL 6 IL 8 IL 10 with consequent reduction of IL 12 and interferon g a MSH with reduction of IL 1 and TNF a and PGE2 with inhibition of the activation of lymphoid cells Th1 and inhibits the expression o
20. nd the button turning yellow e Position the head of scanning laser at a focal distance of about 300mm from the treatment area e Start the treatment by pressing the Start button or by pressing the pedal External start e Inthe main screen the status bar will indicate in yellow color Laser Temperature Control independently verifying the temperature of the laser source the system will also test the laser power output without emission ALBA 355 user s manual Rev 1 0 _4 2012 19 nape selection Fluence J cm 1000 o 2000 era 4000 Supplied fluence J cm Off Remaining fluence Ala att Jicm LASER temperature RF driver Bu Cooling system 04 09s Shutter R ining ti LASER power supply emaining time LASER controller S I Se X e Once the temperature and laser emission test is finished the system will emit laser radiation towards the patient On the screen this state is shown by an highlighted green bar with WORKING LASER writing and by the laser emission symbol at the bottom also the red warning light aside the screen is on Fluence J cm mm A 50 gt 70mm E 1000 o 2000 Treat am 4000 Supplied fluence J cm Off Remaining fluence edi Ala 50 J cm LASER temperature RF driver Estimated time O Cooling system 09 18s Shutter R ining ti LASER power s
21. nformation regarding the CE Marking e the product is accompanied by the Declaration of conformity required by the Directive ALBA 355 user s manual Rev 1 0 4 2012 4 1 PRESENTATION General indications This manual is intended to help using the medical device in a correct and informed way for good performances and in maximum safety To this scope any operator using regulating and maintaining the device MUST necessarily know the information presented in this manual Conventions PON WARNING WARNING MESSAGES INDICATE THAT FAILURE TO FOLLOW DIRECTIONS COULD RESULT IN SEVERE DAMAGES TO PERSONS AND PROPERTIES EO WARNING IT IS PROHIBITED USING CONTROLS SETTINGS OR OPERATIONAL PROCEDURES DIFFERENT FROM THE ONES DESCRIBED IN THIS MANUAL a eis WARNING THIS MANUAL HAS BEEN REALIZED TO SHOW OPERATORS HOW TO USE THE DEVICE SOME FEATURES DESCRIBED IN THIS MANUAL MAY VARY ACCORDING TO DEVICE VERSION DO NOT USE THE DEVICE BEFORE READING AND UNDERSTANDING THIS MANUAL S NOTE NOTES ARE PARTICULARLY IMPORTANT IN COMPARISON TO THE REST OF THE TEXT Manufacturer data ELETTRONICA VALSERIANA S r l Via S Carlo n 45 47 24020 Casnigo BERGAMO Italy Tel 39 035 726301 Fax 39 035 740758 E mail info evlaser com How to command further copies You can purchase further copies of this manual from the manufacturer ALBA 355 user s manual Rev 1 0 4 2012 5 2 SAFETY Safety integration principles The device presented in th
22. o introduce a therapeutic protocol based on the same energetic intensities of UVA but without the aid of chemotherapy drugs In the therapy of psoriasis we therefore used high energy frequencies in weekly sessions that brought to a progressive remission of the therapy We believe the effectiveness of this therapy comes from the demonstrated capability to reduce the proliferation of T lympho cells and the production of cytokines both Th1 and Th2 Vitiligo We have done photo therapies without the aid of chemotherapy drugs in medium doses with biweekly frequency The treated lesions did not exceed the 25 of the total body surface and we excluded peripheral areas The treatment with UVA rays with wavelength included between 320 400 nm UVA would be able to induce skin pigmentation even if the action mechanism is partially unknown A radiation in the UVA1 spectrum stimulates the proliferation and the migration of melanocytes from the hair follicle and from the margins of the lesion the production of melanin through the formation of photo adduced with DNA and the induction of an inflammatory reaction Protocols resuming table J cm2 single J cumulative Sessions per week ATOPIC DERMATITIS 20 1000 3 MYCOSIS FUNGOIDES 130 2000 2 LUPUS ERYTHEMATOSUS 6 250 2 SCLERODERMA 100 1500 2 SCLEROATROPHIC LICHEN 100 1000 2 PSORIASIS 130 1800 3 VITILIGO 100 1500 3 ALBA 355 user s manual Rev 1 0_4 2012 29 Side effects Negative short term e
23. topic dermatitis In controlled studies short cycles with UVA1 with medium or high doses proved to be more effective than combined photo therapy UVAB and topic application of steroids With low doses we obtain lower therapeutic results To a clinic improvement we associate the reduction of the number of eosinophils both circulating and infiltrating skin and the reduction of the number and functionality of lymphoid cells T helper on damaged skin The number and the structure of the Langerhans cells do not change instead The expression of ICAM 1 on the Keratinocytes of the lesion reduces but the plasmatic levels of circulating ICAM 1 don t show variations The plasmatic levels of Eosinophil Cationic Protein ECP reduce while the results of the studies of modifications of other serum parameters like sCD23 mastocytosis tryptase IFN g and total IgE are conflicting Mycosis fungoides High doses of UVA1 proved to be effective in the treatment of mycosis fungoides both in the initial phase of spots or plaques and in advanced shapes such as nodular or erythrodermic lesions The therapeutic action is most likely obtained by the activation of apoptosis mechanisms of malignant T cells infiltrating epidermis and derma Lupus erythematosus Low doses of UVA1 can reduce the entity of some clinical appearance of systemic and subacute lupus erythematosus like cutaneous lesions arthralgia morning muscular rigidity asthenia fever Such clinic
24. upply a LASER controller _ 30mm ALBA 355 user s manual Rev 1 0_4 2012 20 e After previous setting of the parameters the system will show the values of fluence and timing in the mask treatment these data are calculated automatically by the software Supplied fluence It shows the value of fluence delivered during the treatment Remaining fluence It shows the remaining fluence to the end of the treatment Estimated time It shows the estimated duration of the treatment Remaining time It shows the remaining time of the treatment e While working it is possible to pause or stop the treatment by pressing the following buttons It s possible to pause the treatment while working also by pressing the start footswitch e On the screen you will see Treatment in pause highlighted in yellow ALBA 355 user s manual Rev LO 4 2012 21 e To restart the treatment press pause again Before restarting the treatment the system will check the temperature and power of the laser e Once the treatment is completed turn counter clockwise the key to OFF position and press Switch off icon on the screen The system will autonomously switch off Put the general switch in the rear of the machine in position O and disconnect the feeding cable ALBA 355 user s manual Rev 1 0 4 2012 22 Anomalies If during the normal functioning there are anomalies the device turns automatically to
25. use Footswitch Emergency button Fuses Feeding cable User s Manual ba RNP ba ba b bea For EU countries Instructions leaflet for WEEE disposal dak GR arme IT IS FORBIDDEN TO USE PARTS OR ACCESSORIES DIFFERENT FROM THE ONES SPECIFIED IN THIS USER S MANUAL ALBA 355 user s manual Rev LO 4 2012 3 0 CLASSIFICATION Alba 355 is a medical device subject to regulations that may be different according to the country where it is marketed The identification label applied on the back side of the machine shows the information of the equipment that can change according to the country where the product is sold the reproduction of this label is included in Annex 1 to this manual It is forbidden to remove the label in case for accidental reasons the label is damaged removed or the manufacturer s name is removed from it the customer must notify the company Elettronica Valseriana which will provide for the restoration Europe In countries belonging to the European Union and in other countries that recognize the validity of European Directives the Directive applied is 93 42 Medical Devices With reference to this document Alba 355 is considered a Class Ilb device pursuant to Rule 9 as it is intended to release or exchange energy potentially dangerous For products delivered in the countries listed above e identification label includes information regarding the electrical characteristics expected e includes i
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