Radiancy Mistral, User Manual

Page 1: ...User Manual August 2009 Revision 07...

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Page 3: ...User Manual August 2009 Revision 07...

Page 4: ...l Ltd 5 Hanagar St P O Box 7329 Hod Hasharon 45240 Israel Tel 972 9 775 7500 Fax 972 9 775 7511 www radiancy com Authorized European Representative Obelis S A Av de Tervuren 34 Bte 44 B 1040 Brussels...

Page 5: ...MENT PROTOCOLS 17 4 1 GENERAL GUIDELINES FOR THE OPERATION OF MISTRAL 17 4 2 USING THE TOUCH SCREEN COMPUTER 19 4 3 PRE TREATMENT CONSIDERATIONS 35 4 4 PRE TREATMENT PREPARATIONS 36 4 5 SKIN PHOTO REJ...

Page 6: ...lse Counters 19 Figure 9 Password Entry 20 Figure 10 Home Page 21 Figure 11 Tutorial Help Page 21 Figure 12 Settings Page 22 Figure 13 Test Mode 1 25 Figure 14 Test Mode 2 25 Figure 15 Test Mode 3 26...

Page 7: ...e 29 71 Figure 30 72 Figure 31 72 Figure 32 72 Figure 33 Area Adaptor 73 Figure 34 Fuse Location 74 List of Tables Table 1 Handpiece Color Identification 5 Table 2 Technical Specifications 6 Table 3 I...

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Page 9: ...otswitch and up to 8 interchangeable Handpieces Each Handpiece contains a pulse switch a ready indicator light and an application specific lamp The Handpiece is held by the operator and placed directl...

Page 10: ...cations Please review this material to familiarize yourself with controls ports and connectors as well as the consumable items used during treatment 2 1 System Components and Controls The Mistral syst...

Page 11: ...nterface LCD Touch Screen USB Ports On Off Switch Emergency Stop Switch Figure 2 Front Panel Back Panel Power inlet Main power switch Fuse drawer Handpiece cradle Footswith port System fan Air exhaust...

Page 12: ...lamp pulse switch and pulse counter When not in use the Handpiece should be stored in its cradle on the right side of the main unit The main unit will automatically detect the type of handpieces atta...

Page 13: ...val XL Spot Size Hair Removal V VI XL Spot Size Skin Photo Rejuvenation Acne Clearance Psoriasis Care Skin Tightening When handpieces are not in use or attached to the device store them in their cases...

Page 14: ...tening optional 780 1800 nm Fluence 4 25 J cm 2 Pulse Duration Up to 45 sec Spot Size Basic 25 x 50 mm Adaptor Sizes 13 x 50 mm 13 x 35 mm 13 x 12 mm XL HR optional 35 x 50 mm Pulse Generation Method...

Page 15: ...stral s nominal voltage see label at the bottom of the system console conforms to the electrical voltage of your electrical outlet Make sure that the electrical outlet has proper grounding Do not open...

Page 16: ...resulting in burns crusting or abnormal pigmentation As a safety precaution always have a first aid kit equipped to treat burns at your disposal Operator should wear safety goggles when operating the...

Page 17: ...the correct working energy setting Pigmented moles and beauty spots and any suspicious abnormal pigmented lesion should be covered with a non flammable white sticker 2 2 3 Labels This section describe...

Page 18: ...s IIa device The number 0344 is of the notifying body KEMA Notified Body Protect the environment by not disposing of this product with household waste 2002 96 E Check your local authority for recyclin...

Page 19: ...ufacturer details voltage information and the system s serial number Located on Mistral Handpieces HR Handpieces Basic and optional XL HR V VI Handpiece optional Basic and XL SR Handpiece AC Handpiece...

Page 20: ...SYSTEM DESCRIPTION 12 Revision 07 August 2009 Label Location and Comments On rear panel This warning appears on all handpiecess next to opening...

Page 21: ...Emission Clause 36 202 Immunity Harmonized Standards Medical Electrical Equipment Part 1 General Requirements for Safety IEC60601 1 1988 A1 1991 A2 1995 EU Directives Low Voltage Directive 2006 95 EC...

Page 22: ...e Handpiece HR Sensitive XL Handpiece Client Safety Goggles 3 Area Adaptors 2 Packs of Hygienic Rings 10 hygienic rings per pack Footswitch Power Cable User Manual 2 Fuses Treatment Coat Touch Screen...

Page 23: ...ystem occurs the fuse will burn out and the system will not run 3 3 Installation Mistral is designed for easy installation and does not require any site preparation Installation is carried out as foll...

Page 24: ...ly pull and pop out connection After the handpiece s are connected Plug the system into a designated electrical outlet Test the system for proper operation Again always make sure the handpiece is secu...

Page 25: ...connected handpiece the proper treatment mode Make sure the handpiece s you have connected are appropriate to the application s you will be treating 3 Test Energy Levels Always use the test energy set...

Page 26: ...a handpiece is first used and will automatically direct the operator to the appropriate testing screen 11 Excessive Energy Level Stop treatment if overall redness of the treated area is observed Full...

Page 27: ...mergency Stop Button When it is necessary to immediately stop treatment push the red Emergency Stop button located on top of the system 15 Pulse Counter Counts the total number of delivered pulses for...

Page 28: ...eat sessions and having patient history will streamline future treatment sessions This section will describe both forms of treatment protocols 4 2 1 System Startup 1 After inititating start up the sys...

Page 29: ...h to go next Figure 10 Home Page 4 Training Figure 11 The tutorial page allows access to a Mistral training video and the help file Figure 11 Tutorial Help Page 5 Settings Figure 12 For first time use...

Page 30: ...t Using the stylus for calibration is highly recommended ii Hold in place until target moves iii Follow the target around the screen until calibration is complete iv After calibration tap the screen o...

Page 31: ...Treatment previous patient select patient select Application select Test Mode After entering Test Mode Figure 13 and 14 an orange frame will blink around the buttons to guide you through each step Si...

Page 32: ...ses next to each other to aid in comparison and observation k The proper setting is the test area that produced the required result according to treatment application Refer to the section of the user...

Page 33: ...ng proper parameters save data The data will be available for your next treatment session Figure 13 Test Mode 1 Figure 14 Test Mode 2 3 Direct Treatment After testing note results 4 Data Base After te...

Page 34: ...session must be cancelled early you have the option to save results already obtained Figure 16 Test Mode 4 4 2 3 Direct Treatment 1 Select application Only applications that are related to the attache...

Page 35: ...he green check mark will be replaced by an orange sun c Apply pulse wait for the audible ready signal press the foot switch then the one of the handpiece pulse switches d Continue treatment using dete...

Page 36: ...skin cool and safe Hair Removal and Skin Tightening treatments should follow the following protocol a Select OPT pulse pattern The default is the medium pulse width and testing should always begin th...

Page 37: ...es upper case letters lower case letters and numeric The standard keyboard contains all lower case letters and a limited number of commonly used characters The upper case keyboard includes all upper c...

Page 38: ...your patient quickly and easily Enter the first few letters or digits into one of the search fields Once you have found your patient select Patient Details to bring up their data base Figure 20 DB Pat...

Page 39: ...ed with other devices or treatments prior to using Mistral Pigmentation This refers to the degree of any previous pigmentation changes that your patient may have experienced with other devices or trea...

Page 40: ...drop down menu will appear to give you a more focused treatment selection All treatment details will be saved to the data base 6 Only applications that are related to the attached handpieces will be a...

Page 41: ...ion has a drop down menu for a more focused treatment target The treatment area will be saved to the data base Refer to the table below for complete treatment area selection options Table 5 Data Base...

Page 42: ...once again to the Data Base application selection page Figure 25 Figure 26 DB Treatment Mode 11 Administer Treatment a Use the preprogramemd energy level or adjust using the arrows or number pad b Co...

Page 43: ...for the same condition previous hair removal habits and any information as to whether the patient is easily irritated by shaving has had any reactions to waxing or if their skin is generally sensitive...

Page 44: ...nded e g EMLA Elamax Topicaine If a topical anesthesia is applied carefully follow the instructions found in chapter 4 4 4 4 4 Pre Treatment Preparations 4 4 1 Prior to Treatment Have the patient sign...

Page 45: ...arring This can reveal a potential for pigmentary changes Also keep in mind that the patient s skin tone may appear darker during the summer when there is greater sun exposure If there is any doubt re...

Page 46: ...ion Therefore for each of the procedures listed below the energy level should be optimized for that application according to both the individual patient and the specific area being treated The energy...

Page 47: ...it begins to lose peak effectiveness Apply liberally but do not rub it into the skin Cover with an occlusive adhesive clear plastic or nylon dressing Immediately before treatment at least 60 minutes...

Page 48: ...ndications Mistral should not be used on patients who Are pregnant or lactating Have tanned by sun or artificial tanning machine within the last 21 days Have a tattoo or permanent makeup in the treatm...

Page 49: ...ss the patient has consulted their physician and received prophylaxis treatment prior to treatment Have a history of skin cancer or patients who have areas of potential skin malignancies Have received...

Page 50: ...at 40 Next refer to Table 7 for the required reaction If the required reaction in the target area is observed this is the appropriate energy level to begin treatment If the required results do not app...

Page 51: ...for treatment Redness that lasts more than 20 minutes after the pulse Blistering Burning sensation that lasts more than an hour or two Redness should be subtle and diffuse not reflecting the shape of...

Page 52: ...covered with a white nonflammable sticker For proper treatment redness or change in pigmentation color should appear on the spot but not the surrounding skin When using Area Adaptors make sure to use...

Page 53: ...rgy to the maximum level the skin will tolerate without adverse side effects If significant improvement is not observed within 4 treatments consider early termination of treatment Treat only the vascu...

Page 54: ...ees Use extra caution when treating the neck and due to bone proximity the back of hands and d collet Lower the energy level by 5 10 points Maintenance treatments should be performed as needed 4 5 7 P...

Page 55: ...ant hair reduction was also observed 3 6 months after the last treatment session in both females 71 and males 58 Average number of sessions for females 5 5 for males 7 5 Side effects were all minor an...

Page 56: ...ty These include but are not limited to gold therapy tetracycline or sulfa drugs and certain psychiatric medications In case of uncertainty regarding photosensitizing side effects have the patient con...

Page 57: ...ing clean dry and cover spots as outlined in section 4 4 1 Be sure there are no unattached hairs left on the skin surface before beginning treatment Pre treatment test settings After choosing the HR a...

Page 58: ...he tables If at any point there is an adverse reaction lower the energy level to the highest level that did not cause this adverse effect Resume treatment only after the skin has fully healed 4 6 5 Tr...

Page 59: ...applying the pulse As treatment progresses the remaining hair will turn lighter in color and texture Raise the energy levels accordingly Energy Adjustment for Fine Hair If the chosen energy level prov...

Page 60: ...the Client Some symptoms that may indicate if a woman s hair growth is related to a hormonal imbalance are Irregular menstruation Obesity Deepening of the voice Small breast size Baldness or sparse ha...

Page 61: ...not use any other method of hair removal while undergoing LHE treatments the initial frequency of each treatment course takes into consideration the patients desire to be hair free previous methods of...

Page 62: ...t the treatment course This photo history may be presented as part of the consent form 4 6 7 Post Treatment Care Observations mild redness in the treatment area is normal and can last anywhere from a...

Page 63: ...ts were Fitzpatrick skin Types I IV Based upon a pre treatment test on each subject the highest energy level that showed no side effects in that patient was used for treatment Results A mean decrease...

Page 64: ...s due to differnet diseases conditions e g diabetes or medicinal intake Have a history of skin disorders such as vitiligo or psoriasis in the treatment area Have a history of local skin infections Hav...

Page 65: ...ther condition which in the practitioner s opinion would make it unsafe for the patient to be treated 4 7 4 Pre Treatment Test Acne Clearance Set the energy level for the first pulse according to the...

Page 66: ...ffect Resume treatment only after the skin has completely healed 4 7 5 Treatment Principles Before administering treatment refer to section 4 1 Carefully follow the guidelines presented there The pati...

Page 67: ...aggravation of symptoms may occur due to inflammatory response after 3 4 treatments This is a natural part of the healing process and will resolve itself within days Adaptors The Mistral handpiece has...

Page 68: ...who completed the treatment regimen average global PSI score for the treated sites was reduced by 65 In contrast on the control sites average global PSI score was reduced by only 7 4 Six patients 55...

Page 69: ...matological conditions and is specifically indicated to treat mild and moderate plaque psoriasis which includes the treatment of patients with Fitzpatrick skin types I VI 4 8 4 Contraindications Under...

Page 70: ...xis treatment prior to treatment Have a history of skin cancer or patients who have areas of potential skin malignancies Have received chemotherapy or radiotherapy treatments within the past 5 years s...

Page 71: ...cylic acid should be applied a few hours from the treatment preferably before the treatment administration Have the client sign your consent form prior to treatment 4 8 6 Pre Treatment Preparation 1 C...

Page 72: ...d redness and erythema without blistering If all energy levels are suitable treat with the higher one 4 8 7 Treatment Procedure Skin Preparation If the client has extremely rough skin instruct your pa...

Page 73: ...e week e g 3 4 days between treatments If no results are seen after 3 treatments increase energy by 10 Stop treatment immediately if any of the following occurs Extreme Redness Blistering or Burning R...

Page 74: ...tanned by sun or artificial tanning machine within the last 21 days Have a tattoo or permanent makeup in the treatment area Have abnormal skin conditions due to differnet diseases conditions e g diabe...

Page 75: ...history of skin cancer or patients who have areas of potential skin malignancies Have received chemotherapy or radiotherapy treatments within the past 5 years should not be treated without their actin...

Page 76: ...ne the skin s reaction If you do not observe any of the required results in the test area increase the energy level according to the table until you observe the required reaction s Test pulses should...

Page 77: ...l the end of the pulse A flashing LED will appear during the application of the pulse When the pulse is finished an audible signal will sound to indicate the end of the pulse Since the pulse is in the...

Page 78: ...d be performed as needed 4 9 5 Post Treatment Care In addition to post treatment care described in section 4 1 advise the patient to avoid bathing in hot water facial peeling creams or preparations th...

Page 79: ...ctrical equipment Avoid getting cleaning solution into the machine Spray directly into the cloth and not onto the unit itself Do not use cleaning solutions that contain ingredients that may harm plast...

Page 80: ...s removed Figure 31 Figure 31 3 Use Tip A to gently rub along the length of the lamps between the lamp and reflector until the debris is removed Figure 32 IMPORTANT Do not let the sponge part of the c...

Page 81: ...ng different size and shape areas For hygienic reasons clean the area adaptor between each patient with a soft damp cloth as you would the handpiece Figure 33 Area Adaptor To install the Area Adaptor...

Page 82: ...estore the energy after a fuse is blown turn off the unit and disconnect the system from the electrical outlet Wait 5 minutes Pull out the fuse drawer located in the back panel Replace the fuse and pu...

Page 83: ...rse Event Any unwanted medical occurance in a subject whether or not it is device related Outcomes attributed to the adverse event Hospitalization mm dd yy _______ _______ _______ Required interventio...

Page 84: ...________________________ What sort of treatment was performed _______________________ What was the treatment area ___________________ First time the adverse effect was observed mm dd yy _____ _____ _...

Page 85: ...ile discharge report ect ____________________________________________________________ ____________________________________________________________ _____________________________________________________...

Page 86: ...ly Connect the Footswitch The cooling unit was on but later stopped working The Footswitch was not pressed for the past 60 seconds Press the Footswitch to start the system again The Ready beep is not...

Page 87: ...that the handpiece placed on the treatment site is hot prior to triggering a pulse The cooling airflow is blocked because hair has accumulated in the filter Replace the filter The cooling air flow is...

Page 88: ...5 Hanagar St P O Box 7329 Hod Hasharon 45240 Israel Mistral Warranty Card User Information System Details Name Serial Number Street Purchase Date City Comments State Zip Code Tel Fax Mobile E mail Was...

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Page 91: ...oad South Orangeburg Suite 200 New York 10962 USA Tel 1 845 398 1647 Fax 1 845 398 1648 Toll Free 1 888 661 2220 RADIANCY INC RADIANCY LTD 2007 2009 Radiancy Inc All Rights Reserved 2011580 Rev 07 Aug...