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Disposal

1590 99 002_1 - 21. Februar 2011

Disposal

The device is to be disposed of according to regulation 2002/96/EC of the European Council for
Waste Electric and Electronic Equipment [WEEE] or the specific national regulations on waste electric

and electronic devices, as amended.
Please consult our Technical Service if you have any questions regarding disposal.

Содержание MeDioStar

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Страница 3: ...User Manual MeDioStar MeDioStar NeXT...

Страница 4: ...Contents 1590 99 002_1 21 Februar 2011...

Страница 5: ...er Manual must be studied carefully before using the device and all warnings and instructions are to be observed during its operation It is of particular importance that all persons in the room in whi...

Страница 6: ...Contents 1590 99 002_1 21 Februar 2011...

Страница 7: ...ical hazards caused by laser emission 6 2 5 2 Laser induced fire hazard 8 3 Technical data 9 3 1 Device models 9 3 2 Specifications 9 3 3 Technical description 11 3 4 Safety units 12 4 Start up 15 4 1...

Страница 8: ...aser ready mode and releasing the emission of the laser beam 40 5 8 4 Changing the handpiece 42 5 8 5 Switching off the device 42 6 Application 43 6 1 General instructions 43 6 2 General treatment inf...

Страница 9: ...eatment of acne 63 6 7 Skin rejuvenation 64 7 Accessories 66 8 Cleaning disinfection and sterilization 67 8 1 General rules 67 8 2 General advice for cleaning and disinfecting the handpieces 68 8 3 Sp...

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Страница 11: ...information concerning the safe operation of the device 1 2 Symbols in the User Manual In this manual the following symbols are used to draw your attention to dangers or to give instructions on operat...

Страница 12: ...aid purposes of during about 15 years They do not claim to completeness or unlimited validity Light sensitivity Usage of preparations that increase sensitivity to light Cellulite therapies in the trea...

Страница 13: ...and confirmed the training course by their signature in the Medical Device Logbook Among other institutions Asclepion Laser Technologies GmbH also offers courses for laser expertise in medical applica...

Страница 14: ...d improperly Absolutely observe the instructions given in this User Manual for equipment and procedures for operating maintaining checking or calibrating purposes WARNING The laser radiation of the de...

Страница 15: ...ted by electromagnetic interference generated by other devices that conform to the same standard Moreover the system does not generate electromagnetic radiation beyond the limiting values indicated in...

Страница 16: ...d to the international standard EN 60825 It is complemented by national regulations providing general protection from dangerous laser radiation Their purpose is to protect operating personnel and pati...

Страница 17: ...such as watches rings bracelets or similar belongings from the working range and refrain from the use of reflecting instruments or other comparable materials where possible Reflecting objects can inte...

Страница 18: ...f solvents such as alcohol or isopropyl alcohol directly before and during the treatment the vapour should be removed by aeration before activation of the laser or at least wait for some time Please u...

Страница 19: ...Specification MeDioStar Device model Floor based unit Display Operator guidance Touchscreen Cooling Internal cooling cycle Door interlock connector 5 V 10 mA Laser warning lamp Potential free relay c...

Страница 20: ...oggles acc To DIN EN 207 2009 800 950 nm D LB5 Pulse duration max 400 ms depending on the mode and handpiece Pulse energy max 60 J Pulse frequency max 12 Hz depending on the mode and handpiece Spot si...

Страница 21: ...can store treatment reports with the parameters typically used for various types of treatment Cooling The internal cooling system is required to prevent the component groups from being overheated The...

Страница 22: ...unlock this button after the elimination of the emergency turn it to the left until it jumps out again Note The Laser emergency STOP switch should not be used to turn the system on and off in its nor...

Страница 23: ...in the OUT O position Power switch Figure 3 Power switch at the rear panel of the device Foot switch The foot switch is an electric button that releases the laser emission if the laser is activated an...

Страница 24: ...konnte nicht gefunden werden Fehler Verweisquelle konnte nicht gefunden werden Remote door interlock contact The system is equipped with a remote interlock contact that may be connected to the entranc...

Страница 25: ...s been made expressively Please keep the packing for the future safe consignment of the device CAUTION Refrain from start up action of any kind if the device or its accessories are found to have suffe...

Страница 26: ...1 February 2011 4 2 Installation 4 2 1 Device design Handpiece with integrated skin cooling Handpiece holder Display with touchscreen Key switch Laser emergency STOP switch Figure 5 Connections at the...

Страница 27: ...of potential equalization Figure 6 Connections at the rear panel of the device 4 2 2 Labels at the device WARNING The laser device emits high levels of radiation in the infrared range that may cause...

Страница 28: ...erture at the handpiece Figure 9 Laser warning label EN 60 825 1 Figure 13 Labels for interface conncetions at the rear panel of the device Figure 10 Label for potential equalization connection Figur...

Страница 29: ...are connected here Master Service and USB are exclusively designed for authorized personnel 1 Master interface 2 USB interface 3 Remote interlock contact connector 4 Connector for foot switch 5 Servi...

Страница 30: ...source WARNING The laser device emits high levels of radiation in the infrared range that may cause serious damage to the eye if the device is used improperly Therefore warning and information labels...

Страница 31: ...cient cooling of the device please keep a minimum distance of at least 20 cm between its lateral and rear sides to the wall CAUTION Fix the wheels of the device to ensure that it cannot be moved unint...

Страница 32: ...arting a treatment that the laser cannot be switched to the READY mode with this door being open In case of malfunction please inform the Technical Service An external voltage source for a low voltage...

Страница 33: ...ith integrated skin cooling Figure 16 Handpiece MeDioStar with skin cooling The laser spot size can be varied by changing the handpiece The system automatically detects the new handpiece optional and...

Страница 34: ...irst plug the mains cable into the power inlet socket at the rear panel of the device before connecting the other end with the mains plug The operation of the laser requires that the device is connect...

Страница 35: ...Switch the power switch at the rear panel of the device to I O Figure 6 2 Verify that the Laser emergency STOP is deactivated not pressed 3 Then put the safety key into the key switch and turn it clo...

Страница 36: ...function press the corresponding fields on the display By pressing the keys on the right side of the display you can browse through lists consisting of several pages e g Indication lists To select par...

Страница 37: ...nformation on the individual treatment Setup General settings for the device can be made via the display Asclepion Experience the advantages of the Asclepion Web Club Tools Saved special functions for...

Страница 38: ...fferent languages Sound Setting the sound volume Release indication New indications must be released Import export Allows the export and import of the patient database the indication list and the libr...

Страница 39: ...The screen appears see figure below Figure 20 Patient database screen Function parameter Display remarks New patient You have the option to include a new patient in your database After pressing this...

Страница 40: ...the key to add special characters of foreign languages Also here you can press the or key to write caps To return to the original keyboard layout press the key again Tip four digits and makes sense Ot...

Страница 41: ...ilation BASIC Photos Photos before and after the treatment if existing Videos Videos of treatments if existing Application Fields of application of the treatment Contraindications Contraindications Pr...

Страница 42: ...Operation 32 1590 99 002_1 21 February 2011 Figure 24 Library photos Figure 25 Library videos To enlarge the photos or to start the video please touch a photo or the video...

Страница 43: ...on Laser Technologies the company strategy and marketing tools Are you already a member of our exclusive Web Club If you are not you can inform about our offer here Figure 26 Asclepion Effect 5 6 Star...

Страница 44: ...tment Depending on the reaction to the test treatment they are to be reduced or increased See chapter 6 Start via Patient database This option is recommended for continuing a treatment 5 6 1 Start via...

Страница 45: ...eatment screen of the indication will be opened Refer to chapter Fehler Verweisquelle konnte nicht gefunden werden Fehler rweisquelle konnte nicht gefunden werden for setting the parameters 5 6 3 Star...

Страница 46: ...section describes how to set the parameters for the individual treatment and how to save them First activate the Treatment screen Figure 31 Treatment screen Select the parameter you want to change by...

Страница 47: ...favorite If you want to save the settings for an already recorded indication the old data will be overwritten To call the saved parameters open the indications list See chapter 5 6 2 5 8 Settings for...

Страница 48: ...e highest fluence is not simultaneously possible with the shortest pulse duration The spot size can be changed by changing the handpieces and is automatically recognized by the device and displayed In...

Страница 49: ...considers multiple pulses Temperature skin cooling cold medium warm recommendation cold Cooling water pump Is switched on automatically after changing the handpiece Energy indication Indication of th...

Страница 50: ...operation all persons present in the laser room have to wear protective eye goggles or patient eye shields appropriate for this laser as specified in chapter 3 Other types of laser protective eye wear...

Страница 51: ...ooling temperature is reached the emission of the laser radiation will be interrupted and the cooldown handpiece screen will be faded in The treatment can be continued as soon as the cooling tip is co...

Страница 52: ...s menu When the handpiece has been changed the system switches on the pump automatically 5 8 5 Switching off the device Exit the mode and switch to mode by pressing the key To switch off the laser dev...

Страница 53: ...y be applied by users who are adequately qualified to do so based on their professional training background expert knowledge and practical experience Make sure you have understood the principles of la...

Страница 54: ...t simultaneously It is important to bear in mind that the side effects can be stronger for the treatment of larger areas than for the treatment of a smaller test area Besides the patients get a better...

Страница 55: ...800nm and 950nm has a relatively high melanin and blood absorption The wavelengths of the different handpieces are optimal adjusted within this range to the individually planned indication However you...

Страница 56: ...mples However for an effective treatment the required fluence and spot size are defined first Only afterwards the shortest possible pulse is set for thin structures and light skin For dark skin it is...

Страница 57: ...ime 6 2 2 Classification of skin types Skin type I skin type extremely fair skin blond or red hair freckles blue or green eyes always sunburn no tanning II frequent in Central Europe fair skin blond h...

Страница 58: ...pulsed lasers like the MeDioStar It is to set directly on the display The higher the fluence the more efficient the treatment but stronger side effects are possible Therefore test treatments are to be...

Страница 59: ...e small spot of the VAS handpiece The mode can be used for vascular treatments too The mode can also be used for the epilation of larger areas particularly for darker skin Contrary to all the other tr...

Страница 60: ...e hair with a maximum lasting effect 6 4 1 The target anatomy of hair simply plucking out unwanted hair It will grow again This means that the structures responsible for hair growth have to be destroy...

Страница 61: ...om this point on the human hair is subject to repeating growth cycles which may extend from some months to some years depending on the body region The active growth phase is termed anagen whereas telo...

Страница 62: ...epilation of dark hair is particularly effective because dark hair has higher melanin content Light hair typically requires higher energy densities that are tolerated because of the normally lighter...

Страница 63: ...hildren should NOT be treated because clinical studies do not exist for these patients CAUTION Patients with tanned skin especially fresh tanned can develop more intensive side effects particularly su...

Страница 64: ...tion with the MeDioStar causes relatively little pain thanks to the precooling with the cold metal probe of the handpiece For sensitive body areas or very extensive treatment areas a topical anestheti...

Страница 65: ...completely lasered the device must be switched to the mode Only if a skin reaction cannot be seen after 10 minutes the energy density FLUENCE can be increased gradually test on a new area In the mode...

Страница 66: ...hair and skin type result desired by the patient often remaining fine hair are accepted interval between the treatments To achieve a satisfactory result four to seven treatment sessions may be necess...

Страница 67: ...Application 1590 99 002_1 21 February 2011 57...

Страница 68: ...tic problem The method of choice is sclerosing The effectiveness of this therapy has been shown for decades However many patients prefer a laser treatment Generally the success rate of the laser treat...

Страница 69: ...for said purposes They do not claim to completeness or unlimited validity CAUTION The higher fluence required for the treatment of dilated vessels and the stronger absorption due to the size of the ve...

Страница 70: ...connected with heat It can even be a feeling of burning in case of thicker vessels After the treatment an erythema can be seen in the course of the vessels If the vessels are thicker the formation of...

Страница 71: ...ver the lower the treatment speed the longer the pre cooling time for the next area to be treated WARNING Laser radiation can cause serious damage to the eye Everyone present in the laser room during...

Страница 72: ...usly cooled for at least 10 minutes Due to the consequent cooling this procedure leads to a reduced sensation of pain and to a reduction of the side effects 6 5 7 Post treatment After cooling the skin...

Страница 73: ...ourse of the disease they show recidivism and confluence to formations similar to carbuncles Often flat scar plates with a thickness of centimeters are caused They have cutaneous subcutaneous fistulas...

Страница 74: ...c once a month before As an additional finding the smell development was reduced Compared with earlier investigations it can be said that a further therapeutic option for treating acne inversa exists...

Страница 75: ...atment for hair reduction which is skin contact with clear gel coupling All patients were treated with energies commencing at 25 J cm and increasing in 5 J cm increments until darkening of the lentigi...

Страница 76: ...nt information We strongly advise against the use of accessories made by other manufacturers Even if an official testing authority should have certified that a specific accessory unit could be used sa...

Страница 77: ...aned and disinfected immediately following use and before application on a patient If it should be necessary to clean the device during a treatment the device must be switched to the STANDBY mode befo...

Страница 78: ...ssories should be performed as soon as possible after their use For this purpose they are to be removed from the device Disassemble accessory units if required by following the instructions provided i...

Страница 79: ...stored in a clean condition and protected against contamination Ensure that the parameters of the correspondingly admissible ambient conditions indicated in chapter Technical Data are given The manufa...

Страница 80: ...r tip of the handpiece remains clean For this reason the optical contact surface must be checked regularly and cleaned by using a clean lint free damp cloth You can for example rapidly wipe off the su...

Страница 81: ...in plain text Some faults can be removed by the user For doing this follow the instructions on the display WARNING The laser is operated with line voltage There is the risk of an electrical shock and...

Страница 82: ...error code displayed Fault message Explanation Corrective action Communication error all 50 XXX errors The communication is interrupted Start the device anew Operation can be continued Please contact...

Страница 83: ...tem Function keys of the display do not react or only sporadically Faulty calibration of the touchscreen The calibration is to be performed by an authorized service engineer Therefore inform your vend...

Страница 84: ...given below When contacting your service partner of Asclepion Laser Technologies GmbH always keep the model and the serial number of the device at hand These numbers are specified on the type plate l...

Страница 85: ...output power of the therapeutic laser must be checked by a service technician of Asclepion Laser Technologies GmbH or a qualified service technician of the distributor within the technical safety chec...

Страница 86: ...s measurement of the actual output power of the laser modules at the handpiece calibration of laser power if necessary functional test Tip To inform yourself about the extent and performance of the sa...

Страница 87: ...of according to regulation 2002 96 EC of the European Council for Waste Electric and Electronic Equipment WEEE or the specific national regulations on waste electric and electronic devices as amended...

Страница 88: ...Disposal 78 1590 99 002_1 21 February 2011 13 EC declaration of conformity...

Страница 89: ...ply line 5507 04 013 3 0 m Important information This device is subject to special terms of network connections The maximally allowed impedance of the power grid is Zmax 0 1753Ohm at the power supply...

Страница 90: ...use in all establishments including domestic establishments and those directly connected to the public power supply network that supplies buildings used for domestic purposes Emitted interference of...

Страница 91: ...spital environment Surges acc to IEC 61000 4 5 1 kV series mode voltage 2 kV common mode voltage 1kV 2kV Mains power quality should be that of a typical commercial and or hospital environment Voltage...

Страница 92: ...stance in meters m a Field strength of fixed radio transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range b Interference may occu...

Страница 93: ...ce meter Protection distance meter Protection distance meter 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 74 1 1 17 1 17 2 33 10 3 70 3 70 7 37 100 11 70 11 70 23 30 For transmitters rated at a maximum output...

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