Nexus 10W Laser System
Contents
1. 7 Standby key system into STANDBY status 8 4 3 LCD touch screen that displays system and laser information 9 Emergency stop stops laser emission when depressed 10 Function key sets laser parameters e Set laser power e Set laser pulse parameters e Set options e Select treatment protocol Left View of Nexus 10W IR Laser System 16 Handle __________ 11 Remote Interlock 12 Foot or hand switch socket 13 Power socket 15 Battery bracket 14 Main Power switch 11 Remote interlock Can be connected to the room door so the laser will stop in the event of entry during lasing 12 Foot or hand switch socket Version V2 1 Operating Instructions Nexus 10W Page 11 of 42 Clearly Beautiful Nails LLC clearly nailf Nexus 10W obile laser 13 Power plug DC 26V 4A 14 Main Power switch turns system power on 1 or off 0 15 Battery bracket houses Li lon rechargeable battery 16 Handle Rear View of Nexus 10W IR Laser System 17 Battery charge indicator 18 Battery output 19 DC input socket 17 Battery charge indicator the indicator light is orange when battery is charging and the indicator light turns to green when the battery is fully charged 18 Battery output DC 24V 19 DC input socket use the supplied AC DC adaptor input is 26V A View of Nexus 10W IR Laser System Foot and Hand Switch Version V2 1 Opera2. or in Standby mode prior to inserting the fiber into the laser aperture port Insert the fiber into laser aperture port until fully engaged Make sure the IR Laser probe is screwed in correctly otherwise the security switch in the SMA connector will not be activated and an error message will be displayed amp Handle the fiber with care as damage may occur if struck or bent sharply 9 The Lithium ion battery Warning Do not damage the Li ion battery A damaged battery can cause an explosion or fire and can result in personal injury and or property damage Version V2 1 Operating Instructions Nexus 10W Page 32 of 42 Clearly Beautiful Nails LLC clearly nailf Nexus 10W mobile laser 9 1 Rechargeable battery 24 2V 4A Nominal capacity 2 2AH Chargeable Li lon battery Maximum continuous charge Current 2A Discharge current gt 4A Size 65mm 115mm 20mm HxWxD NOTE Charge the battery for at least 8 hours prior to the first time of use 9 2 Change the battery Install the battery to the main body along the red arrow Version V2 1 Operating Instructions Nexus 10W Page 33 of 42 Clearly Beautiful Nails LLC clearly nailf Nexus 10W mobile laser 10 Safety 10 1 Safety elements Attention Safety elements are part of the laser system They must be used to AN increase the safety in using the Nexus 10W with applications systems or light delivery systems medical probes in a treat
3. in use place the handpiece on a secure resting place The handpiece must not be allowed to fall in order to avoid damage to the optical fiber Version V2 1 Operating Instructions Nexus 10W Page 31 of 42 Clearly Beautiful Nails LLC clearly nailf Nexus 10W mobile laser 8 Application systems and light delivery systems 8 1 Application systems The following application systems are approved for the use with Nexus 10W laser The fiber parameter must satisfy the following e Fiber core diameter at least 400 um e NA20 22 e With SMA 905 connector e Fiberoptic cable must be inspected for damage 8 2 Handling and use of application and light delivery systems Attention The clinical rules concerning the use of medical laser probes must be from violations of the above mentioned rules followed CBN is not liable for accidents or damage to the laser system resulting To ensure the proper and safe use of laser systems only trained licensed practitioners should use the approved applications and laser light delivery systems Warning Pay attention to the application instruction for the application and laser light delivery systems Check the packaging of the IR Laser fiber optic for possible damage IR Laser fibers delivered in damaged packaging should not be used Warning To avoid damage to the laser probe do not hit on a hard surface or over bend the fiberoptic cable Make sure laser is Off
4. 013485 2003 and DIN EN ISO 9001 2000 Version V2 1 Operating Instructions Nexus 10W Page 1 of 42 Clearly Beautiful Nails LLC clearly nailf Nexus 10W obile laser Nexus 10W Operating Instructions Contents 1 WARNINGS AND SAFETY PRECAUTIONS s sss sse 4 2 POST MARKET QUALITY MONITORING se 5 3 PRODUCT DESCRIPTION s esesessese 6 4 TECHNICAL SPECIFICATIONS seseesese 8 SPANELS CONTROLS AND LABELS ae 10 5 1 PANELS AND CONTROLS wai eWeneuiaciies EENE EEEE EENDE NEE ENAT ESAN 10 FOOT SWITCH HANDPIECE HD SV 13 NN 13 5 3 DESCRIPTION OF CONTROLS DISPLAY AND CONNECTORS esrrvvrnnnvrnnnvnnnunnnnnvnnnnnnnnnvnnnnnnnnnnnnnnnnnnnsnnunsnnunsnnnnnnnuenenueneee 16 6 OPERA TING INSTRUCTIONS s s sss sse 18 6 1 PREPARING UNIT BEFORE OPERATION vscscacssenscccacsnavnscsansecentsaanbaciaauttondacadosiendesedibnedieseaateeauseacameannoiaracenayeaessebecsaiasbants 19 PONNI 19 6 3 DESCRIPTION OF THE LASER OPERATION ccccscscceccscceccscceccscceccsccecesccecesccecusccesesccecusccesusccestsccesusceestsseesesceesuseeesese
5. 0W Page 22 of 42 Clearly Beautiful Nails LLC clearly nailf Nexus 10W mobile laser 6 3 1 User Interface The Nexus 10W has two ways to operate the menu touch screen and using function keys 6 3 1 1 Touch screen using touch screen one can change some parameters directly NOTE AN Do not touch the screen with any sharp materials Cautions have to be taken that liquids do not come into contact with the surface of the touch screen 6 3 1 2 Function keys There are 6 keys on the panel STANDBY READY LEFT RIGHT UP DOWN ENTER Version V2 1 Operating Instructions Nexus 10W Page 23 of 42 Clearly Beautiful Nails LLC clearly nailf Nexus 10W mobile laser 6 3 2 Setup laser parameters At the main interface Press the Menu or the Enter function key you will enter the setup interface 5 Set the option parameters 4 Set Custom Pulse 2 System information parameters Custom Pulse System info nd ete interface 1 Set the timer set the timer s count time value 2 System information give the system information 3 Back to main interface back to main interface 4 Set Custom Protocol parameters To select a treatment protocol There are 10 pre programmed protocols that can be selected The user can create amp program one protocol Any of the protocol values can be changed 5 Set the system parameters to set system options e Pilot light beam intensity V
6. 10W mobile laser electric energy into coherent IR laser radiation with a wavelength of 980 10nm pilot beam 635nm 10nm The Nexus 10W has 3 modes of operation CONTINUOUS SINGLE PULSE MODE and CONTINUOUS PULSE MODES Attention The output energy of the IR Heap Laser lies above the safe level for compatibility of the eye and can lead to irreversible eye damage In order to avoid eye damage all persons in the area have to wear the protective eyewear The Nexus 10W model has a maximum optical output power of 10W at 980nm The Nexus 10W meets the intent of Directive EN 60601 1 2 2001 Electromagnetic Compatibility Requirements and Tests Compliance was demonstrated to the following specifications as listed CISPR 11 1990 IEC 801 2 1991 04 IEC 801 3 1993 IEC 801 4 1988 and IEC 801 5 1992 07 Nexus 10W laser can therefore only be used in a professional clinical environment Any operating and servicing is to be done only by qualified licensed personnel Potential electromagnetic or other influences between the equipment and other devices cannot be completely excluded despite appropriate design precautions Inform CBN in such a case Accidental irradiation of tissue other than the target tissue may result in a burn or vaporization regardless of the wavelength Surrounding the target area with moist drapes or saline soaked cotton will keep it moist and greatly reduce this potential hazard Care and precision in a
7. 4 Clearly Beautiful Nails LLC clearly nailf Nexus 10W mobile laser Nexus 10W Laser System Operating Instructions Clearly Beautiful Nails LLC Nexus 10W Manufacturer Wuhan Gigaa Laser Optronics Technology Co Ltd l 4 502 International Enterprise Center Guanggu Road Wuhan 430074 PRC TEL 011 86 27 67848871 FAX 011 86 27 67848873 clearly nail obile laser Model Nexus 10W 980nm 10nm max 10W Clearly Beautiful Nails LLC clearly nailf Nexus 10W mobile laser Manufacturer Wuhan Gigaa Laser Optronics Technology Co Ltd l 4 502 International Enterprise Center Guanggu Road Wuhan 430074 PRC TEL 011 86 27 67848871 FAX 011 86 27 67848873 Medical Device Nexus 10W 980nm 10nm 10W The Nexus 10W meets the requirements of the Annex II of the Directive 93 42 EEC and is classified subject to Annex IX rule 6 as a medical device of Class IIb The product is designed in conjunction with the following safety standards EN 60825 1 Safety of IR Laser products EN 60601 1 Medical electrical equipment EN 60601 1 2 Medical electrical equipment 2 Collateral Standard EN 60601 1 4 Medical electrical equipment 4 Collateral Standard EN 60601 2 22 Medical electrical equipment Part 2 Particular requirements for the safety of diagnostic and therapeutic IR Laser equipment This declaration is based upon a Quality System meeting the requirements of DIN EN I5
8. Continuou CW mode 9 Timer All Peak Power AVERAGE POWER ENERGY COUNT Main Interface Screen nail obile laser i a h 1 System state 2 Protocol list 3 Laser emitting when red Pulse Rate 4 Pulses per second 5 Scroll through protocols 6 Laser pulse count 7 Pulsed mode 8 Treatment protocol 1 System state bar displays status of system parameters se below 2 Protocols access the list of protocols 3 Laser emitting when Laser emitting LED light turns to red color 4 Pulse Rate displays the number of pulses per second 5 Symbol to directly scroll through the list of protocols 6 Laser pulse count displays the total laser pulses emitted 7 Pulse mode select the pulsed emission mode 8 Treatment Protocol displays the current treatment protocol in use 9 Timer when the timer is active the time counts down otherwise the time counts up 10 Continuous Wave CW mode select the continuous emission mode 11 Energy emitted continuously displays the energy emitted 12 Symbol to directly scroll through the list of protocols Version V2 1 Operating Instructions Nexus 10W Page 21 of 42 Clearly Beautiful Nails LLC clearly nailf Nexus 10W mobile laser 13 Pulse power displays the laser peak power 14 Menu to access the screen to change system parameters and Custom Pulse 15
9. Handswitch Safety EN60204 1 Standards EN60947 5 1 VDE0660 Part200 IEC 947 5 1 Safety type IP68 EN 60529 Product Class 1 204 mm x 120 mm x 76 mm HxWxD Weight 2 kg 10 C 40 C Operating Temperature Storage Transport 10 C to 55 C Temperature Humidity Storage Transport 10 80 Operating 30 60 Version V2 1 Operating Instructions Nexus 10W Page 9 of 42 Clearly Beautiful Nails LLC clearly nailf Nexus 10W mobile laser 5 PANELS CONTROLS and LABELS 5 1 Panels and Controls 9 Emergency stop re som 05000 1 Power ON indicator 4 y EE T k sl My Fav FET To om nemne 3 Laser emission ic as ll indicator 8 4 3 LCD 2 Alarm Indicator 7 Standby key 4 Ready key 5 Fiber AT P TBP 6 Handpiece 10 Function key Front of Nexus 10W IR Laser System 1 Power ON indicator the indicator is illuminated when power is ON 2 Alarm Indicator the indicator light in case of malfunction 3 Laser emission indicator the indicator is ON when laser is firing 4 Ready key system into READY status only in this status laser can emit 5 Fiber core 2400um NA 0 37 Version V2 1 Operating Instructions Nexus 10W Page 10 of 42 Clearly Beautiful Nails LLC clearly nailf Nexus 10W mobile laser 6 Handpiece Houses laser aperture from the fiber optic cables
10. IGHT 635nm 10nm 4mW max EN 60825 1 2003 EN 60601 2 22 1996 WARNING Always wear protective eyewear when using this device The optical power IR diode based output from this Laser system can cause severe eye damage or other injuries Always wear protective eyewear when using this unit Exercise extreme caution to prevent injury This equipment is intended for use by trained physicians or licensed healthcare practitioners only and should only be operated by qualified personnel who have familiarized themselves with the operating parameters of this product prior to use The Nexus 10W IR Laser contains a class 4 IR light source according to Directives EN 60825 1 2003 A class 4 IR Laser is hazardous to the eye from both direct beam and diffuse reflection of the beam It also represents significant skin and fire hazards Danger Do not use the unit near flammable anesthetics or other flammable AN substances Avoid eye or skin exposure to direct or scattered radiation Take all necessary precautions in areas in which the laser is being used Near infrared light 980nm from the Nexus 10W can pass through the transparent components of the eye and on the retina at the back of the eye This can there cause an accidental retinal burn Only protective glasses designed for protection from continuous IR Laser radiation at a wavelength of 980nm 10nm with an optical density of OD 24 should be used Glasses not designed to this specification are n
11. Laser wavelength 980nm System state bar Show the option status as depicted below Show the battery remaining capacity there are 4 levels Shows this icon when SOUND is enable Pulsed JUL or continuous mode Shows this icon when PILOT beam is enable Shows this icon when TIMER is enable 6 3 Description of the laser operation The Nexus 10W has two modes of operation CONTINUOUS and PULSE MODE CONTINUOUS MODE the laser will deliver output radiation at the power level specified by the user as long as the foot or hand switch is depressed PULSE MODE the laser will deliver output radiation according to the power level number of pulses and pulse format On Time Off Time specified by the user in the Custom Pulse screen The pulsed format will be repeated as long as the foot or hand switch is held down up to the number of pulses as specified by the user If the foot or hand switch interrupts a pulse train the Pulsed mode will be repeated after the foot or hand switch is depressed again NOTE if the system timer is enable holding down the foot or switch only one time and then released the laser will deliver output radiation at the power level specified by the user until the timer times out If the operator holds down the foot or hand switch again the laser output will be paused until the operator holds down the foot or hand switch again The timer count is also stopped Version V2 1 Operating Instructions Nexus 1
12. Ton and Toff values selected Press the OK button to load the Custom Pulse parameters into the Custom Pulse protocol Press the Back button to return to the main screen To access the Custom Pulse settings select the Custom Pulse protocol in the screen with the protocol list last item in the list Version V2 1 Operating Instructions Nexus 10W Page 28 of 42 Clearly Beautiful Nails LLC clearly nailf Nexus 10W mobile laser 980nm Average Power Pulse Rate Custom Pulse Screen Version V2 1 Operating Instructions Nexus 10W Page 29 of 42 Clearly Beautiful Nails LLC clearly nailf Nexus 10W mobile laser 6 4 Powering down system The laser can be switched off by main power switch NOTE before you power down the system you must place the Nexus 10W to STANDBY status 7 Accessories 7 1 Protective glasses Note The operator and patient must wear protective goggles when the laser is in operation Make sure to use only glasses with an effective optical density around the wavelength of 980nm 10nm 7 2 Power supply DC26V 4A Use SINPRO MPU100 102 desktop power supply adapter or equivalent Version V2 1 Operating Instructions Nexus 10W Page 30 of 42 Clearly Beautiful Nails LLC clearly nailf Nexus 10W obile laser 7 3 Foot and hand switches IP68 level or equivalent Handpieces with Footswitch built in Switch 7 4 Handpiece Note When the handpiece is not
13. _ _ mobile laser Laser labels warning IR Laser class max PPP power wavelength cp Section Labels i Labels KI Ka ma kamaa ee ooo KE mo EO WADI sene HE MAE ME KAA od sin VE ha ammen SE ME KA me KE KAA pa SE ME KN bl bodene MR ME ep ha sn WAA KAA KA ad SA KAA KAA al no KA KA KA iol om vi MO KAA Spe VM mm Measurement of Output Parameters Relevant to Safety CAUTION Always wear laser safety goggles when performing the above procedures Laser Calibration Test Connect a new CBN handpiece to the output port of the IR Laser Put the distal end of the Version V2 1 Operating Instructions Nexus 10W Page 39 of 42 Clearly Beautiful Nails LLC clearly nail Nexus 10W ____ _ mobile laser handpiece into a laser power meter Enable the laser fire the laser and record the values displayed on the laser power meter Place the IR Laser into Continuous Mode Fire the IR Laser and verify with the power meter that the output is within the tolerances Value W 20 Value Min Max iw osn TS ef man SM Ge O a sw 1 2436 11 gt Aw 1 32 48 1 1 gt yt St MW 48 72 wp ses a If the results fall within the expected 20 range then the laser is deemed calibrated No further action is needed CAUTION If the laser falls outside the 20 range then CBN or an authorized AN representative should be contacted 5 Measurement of Output Parameters Passed Comment Relevant to Safety hall Ins
14. a 34 11 1 ROUTINE MAINTENANCE ccccccccsccscesceccscesceccscsescescecescescssescsscusescesescescesescescscescestssescescscescesescescssencesescuscesessesees 34 HEN ne 35 Version V2 1 Operating Instructions Nexus 10W Page 2 of 42 Clearly Beautiful Nails LLC clearly nailf Nexus 10W obile laser 11 3 PLANNED PREVENTATIVE MAINTENANCE cccsceccsccceccscesceccscsceccecscscscesescescscescestssescescscscesescescesencesescuscesensesees 35 UV SERVE POLICO Y rererere neir EEEE OEE ONA EE EEEE NEEE EE ENEE EEREN 35 13 ENVIRONMENTAL PROTECTION ssses sesese 35 Ji WABRANI YO LION ee 36 ITAKUA HAU assesses E A EAE sxe scuusesecduccecutuenieencisenssiencesseenecscaar 37 15 1 DEVICE MASTER RECORD cccsccscecceccscesceccscccscescecescescecescescusesceecscusceseecescscescesessescescscescesescescesencesessesceseusesees 37 BT 37 15 3 ANNUAL MAINTENANCE wwa 38 Version V2 1 Operating Instructions Nexus 10W Page 3 of 42 Clearly Beautiful Nails LLC clearly nailf Nexus 10W mobile laser 1 Warnings and safety precautions THE USER S MANUAL AND INSTRUCTIONS SUPPLIED WIT THIS IR LASER MUST BE FULLY READ AND UNDERSTOOD BEFORE OPERATING THIS DEVICE Visible and Invisible Laser Radiation Avoid Eye or Skin Exposure to Direct or Scattered Radiation CLASS 4 IR LASER DEVICE IR DIODE 980nm 10nm 10W GUIDE L
15. e attention to the red mark system complete attention to the red mark CBN failure Version V2 1 Operating Instructions Nexus 10W Page 17 of 42 Clearly Beautiful Nails LLC Nexus 10W Laser current high Laser damaged Service required clearly nail obile laser Battery power is low Battery warning Charge battery 6 Operating instructions AN Attention All personnel must wear protective eyewear to eliminate the risk of eye damage when operating the laser system Caution Use of the Nexus 10W in any way other than described in the operating instructions can lead to dangerous radiation exposure The operator must care that the treatment room is properly labeled and that nobody can enter the treatment room without wearing protective eyewear Version V2 1 Operating Instructions Nexus 10W Page 18 of 42 Clearly Beautiful Nails LLC clearly nailf Nexus 10W mobile laser 6 1 Preparing unit before operation Plug in the foot or hand switch cable into the 4 PIN interlock connector on the right side of the unit The red mark on the socket is to correspond to the red one on the nut Plug either the interlock plug or the door interlock cable in the 2 PIN interlock connector at the right side of the unit Connect a CBN Q delivery system or a laser probe approved by CBN for the use with the system to the SMA connector located on the right panel Built up the power supply like described in sectio
16. ector port amp Check that when fiber is removed from laser aperture laser goes into and remains in standby mode Version V2 1 Operating Instructions Nexus 10W Page 34 of 42 Clearly Beautiful Nails LLC clearly nailf Nexus 10W mobile laser In case unit fails any of the aforementioned tests do not use device for further treatments but call CBN service immediately Storage conditions Temperature 10 to 50 C Humidity 80 RH non condensing Operating conditions Temperature 10 to 40 C In order to better heat dissipation it is recommended to use temperature of 10 35 C Humidity 30 50 RH 11 2 Cleaning Warning Before cleaning and disinfection of the unit disconnect the laser from the power supply Do not use water as it may infiltrate into the equipment The housing of the laser can be cleaned with a wet cloth A mild antiseptic detergent or a mild cleaning agent may be used Chemical cleaning agents strong cleaning agents and rough cleaning cloths can damage the surface of the housing and therefore should not be used 11 3 Planned preventative maintenance A CBN approved technician or other approved personnel should check the Nexus 10W IR Laser annually and the results of the maintenance should be recorded in the instrument logbook See also the section Annual Maintenance Failure to use a CBN or other authorized CBN personnel during the warranty period will result in the warranty being i
17. ersion V2 1 Operating Instructions Nexus 10W Page 24 of 42 Clearly Beautiful Nails LLC clearly nailf Nexus 10W mobile laser e Sound intensity e Timer enable or disable e LCD backlight contrast e Modify password 6 3 2 1 Use function key in this interface In this interface you can choice what you want change To change the option by pressing the LEFT and RIGHT UP and DOWN key To confirm you can press the ENTER key 6 3 3 Set options When you select Option button you can set the system parameters To change the option value by press the LEFT and RIGHT Change the option with the UP and DOWN keys Press the Enter key to confirm iy O P A 980 nm Time s ON Grr Pilot 4 Sound 07 22 Light 4 Modify Password Version V2 1 Operating Instructions Nexus 10W Page 25 of 42 Clearly Beautiful Nails LLC clearly nailf Nexus 10W mobile laser 6 3 4 Set the timer Use the UP and DOWN key to change the value of the time use the LEFT and RIGHT key to change the selected position The range of the time is 1 to 9999 seconds Version V2 1 Operating Instructions Nexus 10W Page 26 of 42 Clearly Beautiful Nails LLC Nexus 10W 6 3 5 Select treatment protocol 980nm OD Large joint arthrosis Medium joint arthrosis Small joint arthrosis Foot Ankle pain Shoulder Knee pain Lumbar spine pain Thoracic sp
18. es 22 6 3 1 User InterfacCe wwwwmmamanmwnamwnamwamanamwniwwamwnanwn narr narr rnarrr narr snsernnsernnsrnnnsersnannnn 23 6I2 SOUP 1456 DIA AA 24 JNM 25 TNT NN 26 6 5 3 SELECT TREATMENT PRO TOC Oen 27 NTN ad S08 MAT Ne 28 6 3 7 Laser SSR 28 6 3 8 Pulsed Mode Using Custom Pulse Advanced USersJ mmmrrrrrrrreerrrrrseerrerrrrvrrrrrrvrrrerrrrrrrrrrrsererrens 28 PRINS 30 TALC ESSOR NN 30 TN PROTECTIVE GLASSES eneeier EALES Area ESTN 30 TA POWER UPI see ae sitecpeccegncete tape uects va casecmas aceasta cent aa adcaceitatdeedaeneapiisedoniccowssncresGhstn Gaca sia atecdasnnstuamacadiiendaneveaunceeestade saaaeaces 30 Ja FOOT NS NN 31 He JE GJE ALEN EEE EE EE 31 ITERA 31 8 APPLICATION SYSTEMS AND LIGHT DELIVERY SYSTEMS 32 8 1 APPLICATION SYSTEMS vicsiaveceivesccvnviaieds tue dacecpaedcccbenendendaxuntobediiontisdeuevdewnecslest bieneataskbleeddcuneuientawentheehsensunbuey eeadecsen bedaeseesie 32 8 2 HANDLING AND USE OF APPLICATION AND LIGHT DELIVERY SYSTEMS cccsccscceccccceccecceccecceccecceceecteccecteceecusceecuecs 32 9 THE LITHIUM ION BATTERY s 0 0 0 00 0 0 000eee e 32 OTRE CHAR PAPIE EATI PR ee 33 TAAN EEATT Nr 33 KUSALI WA a E A E AAE 34 10 1 SAFETY ELEMENTS sanne Kwa 34 Wro TET I a AA Aa 34 VU MAI NE NAN KW
19. iming and applying laser energy is of paramount importance Version V2 1 Operating Instructions Nexus 10W Page 7 of 42 Clearly Beautiful Nails LLC clearly nailf Nexus 10W mobile laser WARNING Never handle the fiberoptic cable using a clamp as doing so can result in an unsafe use condition Use of a clamp can result in the fiberoptic being bent at sharp angles or fiber damage that in turn can also result in an unsafe use condition The fiberoptic can break causing a burn in the protective jacket and the release of IR laser energy If undetected this condition can result in a burn or ignition of flammable materials Must keep the handpiece with SMA 905 connector clean Otherwise the internal IR diode module could be destroyed by thermal build up 4 Technical Specifications 10W 10 with 980nm diode IR Laser Source GaAlAs semiconductor diode Wavelength 980 10nm Application Light delivery systems 600um diameter fiberoptic cable Core Size use only approved handpiece systems Safety Standards EN 60601 1 1990 A1 1993 A2 1995 EN 60601 1 2 2001 EN 60601 1 4 1996 A1 1999 EN 60601 2 22 1996 EN 60825 1 2003 IR Laser Class Power Supply DC26V 4A Use SINPRO MPU100 102 desktop power supply adapter Lithium ion battery 22 2V 2 2AH Version V2 1 Operating Instructions Nexus 10W Page 8 of 42 Clearly Beautiful Nails LLC clearly nailf Nexus 10W mobile laser Footswitch amp
20. ine pain Cervical spine pain Inflammation Sciatica Plantar Fasciitis Tendinitis Wounds Sprain Strain Toenail fungus Neuralgia Custom Pulse Use the UP and DOWN key to change the selected item When the item is selected it will highlight When an item is selected use the ENTER key to confirm The system will load the protocol parameters into the main interface Version V2 1 Operating Instructions Nexus 10W Page 27 of 42 Clearly Beautiful Nails LLC clearly nailf Nexus 10W mobile laser 6 3 6 System information TYPE DEN7B SN GAO09 D118 REGIST NO 7080036 LASER WAVELENGTH 980nm MAX LASER POWER 7W MANUFACTURE DATE 2009 11 9 The above interface shows the following information Type Serial number The internal IR Laser source module registration number Laser wavelength Laser maximum average power The manufacturing date 6 3 7 Laser emission After selecting the laser parameters press the READY key in the main interface screen and then hold down the foot or hand switch to start laser emission 6 3 8 Pulsed Mode Using Custom Pulse Advanced Users In the Main Screen press the Menu button to access the Custom Pulse option The pulse format is defined by the pulse s On Time pulse width in milliseconds and Off Time the dark time period between pulses in milliseconds The Average Power and Pulse Rate are calculated by the internal computer based on the Peak Power
21. ions Set pulse parameter Laser parameters Repeated Pulse Mode On Time pulse length 1ms 1000ms Off Time interval between pulses 1ms 1000ms Optical power output SMA handpiece connector located on the right panel is the high power light output port IR Laser warning An audible signal will be emitted while the laser is active Power knob will allow the user to select the desired average power output Emergency stop Pressing red button on top of unit will instantly shut down the laser and an error message will appear on the display In this case it switches into the Standby mode Use this button for emergency shut down only Attention Using emergency switch to shut down laser does not shut down the entire system Main power switch Unit is equipped with a main power switch and standard power entry module located at the left panel On 1 Off 0 Power supply Operator is allowed to use the laser with the supplied electrical power configuration only See section Power Supply Before plug in power supply check all connections Version V2 1 Operating Instructions Nexus 10W Page 16 of 42 Clearly Beautiful Nails LLC clearly nailf Nexus 10W _ __ __ mobile laser Foot or hand switch 6 Foot or hand switch must be connected to unit via 6 PIN PIN interlock interlock socket at right side of the unit The red mark on the socket is to correspond to the red one on the nut Laser radiati
22. ment Check that the safety elements are working well 10 2 Possible risk Burning and swelling of the target tissue can occur if the laser energy applied is too high All these potential complications can be avoided if the user is properly trained 11 Maintenance The Nexus 10W has been designed to operate reliably with a minimum of maintenance Note This unit contains no user serviceable parts Any attempt to repair adjust or modify the system beyond those procedures outlined in this manual by any person not authorized by CBN will invalidate the warranty CBN reserves the right in its sole discretion to decide on warranty voidance To prevent the risk of electric shock do not remove the cover Qualified personnel should perform all servicing If service is required contact a factory service representative 11 1 Routine maintenance The following checks should be carried out regularly by the operator Check IR Laser s safety goggles right type mechanically undamaged Check all labels are firmly in place Check the emergency switch Check that disconnection of remote interlock causes the laser to be inoperable and to indicate error message interlock open Check audible signal is active when foot or hand switch is depressed and laser emission is present Check that display indicates error message Fiber not connect laser goes into and remains in standby mode when removing fiber optical handpiece from fiber conn
23. n Power supply Connect an approved light delivery handpiece system by the SMA connector screw the cup nut till hand tight The light delivery handpiece system is completed connected if there is no axial and radial clearance and no turn of fiber is possible Caution AN Nexus 10W must be placed vertically with the battery in place and the bottom panel must be level 6 2 Powering up system Plug in the power supply see Section Power supply To power up unit first turn on the main power switch to the 1 position The display shows the logo picture for 2 seconds Version V2 1 Operating Instructions Nexus 10W Page 19 of 42 Clearly Beautiful Nails LLC clearly nailf Nexus 10W mobile laser After this interface the system reguires the correct password EEG em En GER eee ungen aa aza VJ ms oo ENTER EEE En CANCEL The password is four digits from 0 to 9 the initial password is 0000 EEE Delete current position number ance Cancel all input numbers and clear all the input numbers J Confirm the input password When the correct password is provided the system will display the main interface screen Version V2 1 Operating Instructions Nexus 10W Page 20 of 42 Clearly Beautiful Nails LLC Nexus 10W 15 Laser Wavelength 14 Access system parameters 13 Pulse power 12 Scroll through protocols 11 Energy emitted 10
24. nt or user Reports should be made to CBN Inc 1759 Country Club Drive Cherry Hill New Jersey 08003 TEL 888 510 2410 FAX 866 275 0516 E mail Michael ClearlyBeautifulNails com 3 Product description The Nexus 10W Infrared IR Laser System is a compact air cooled unit It is a complete self contained instrument which includes a high efficiency power supply a microprocessor controller adjustable light output with automatic power stabilization fan cooled as well as a switch panel and LCD screen display panel designed to be user friendly The system includes a high power IR Laser safety features and an SMA fiber output connector The system includes Lithium batteries It can work for 1 hour with no external power input and at maximum power output in pulse or CW in intermittent mode see Section 9 The Lithium ion battery Warning Do not damage the Lithium ion battery A damaged battery can cause an explosion or fire and can result in personal injury and or property damage The IR diodes are made from GaAlAs semiconductor material for high output and superior reliability The IR diodes are enclosed in a rugged factory aligned replaceable environmentally protective module High capacity fans eliminate the need for water cooling and assure low maintenance and reliable laser operation The diodes convert Version V2 1 Operating Instructions Nexus 10W Page 6 of 42 Clearly Beautiful Nails LLC clearly nailf Nexus
25. nvalid 12 Service policy CBN will make available on request schematic interaction diagrams component part lists descriptions and other information that will enable appropriately qualified technical personnel to carry out first line maintenance on the Nexus 10W When parts are deemed to be irreparable by CBN or when special training equipment are required to perform the repair or adjustments the manufacturer reserves the right to withhold information on the grounds of safety In case of returning the Nexus 10W to CBN use its original packaging 13 Environmental protection When the service life of Nexus 10W is used up the laser can be disposed of as the conventional electric products The device causes no known environmental risks Version V2 1 Operating Instructions Nexus 10W Page 35 of 42 Clearly Beautiful Nails LLC clearly nailf Nexus 10W mobile laser 14 Warranty policy CBN warrants the Nexus 10W laser system against defects in material and workmanship for a period of 24 months which will commence on the date of delivery to customer Warranty extension plans will be made available during the warranty period Note Any attempt to repair adjust or modify the system beyond those procedures outlined in this manual by any person not authorized by CBN will invalidate the warranty The warranty will also void in case of Incorrect handling mishandling of the laser Using components not approved by CBN U
26. on emission starts by depressing the foot or hand switch Laser emits radiation for selected treatment time if the TIMER option has been activated Treatment can be interrupted at any time by releasing the foot or hand switch Treatment can be resumed by pressing the foot or hand switch again Interlock light delivery If the interlock plug is not plugged in properly the laser will system and door not work and an error message will appears on the display interlock 4 PIN interlock Interlock error Interlock connectors are located on the right side of the unit A remote interlock switch can optionally be connected via this socket This can be fitted to the treatment room door Unit remains inoperative until this interlock switch is closed or the special blanking plug is used Attention Danger of electrical shock or damage Do not connect the interlock to a power source Light delivery system The laser can be used with light delivery systems with a core diameter of the fiber 2400um The use of fibers with a smaller core diameter fibers of lower quality material or fiber optic light delivery systems not approved by CBN can result in both damage to the system and potential laser safety hazards and will invalidate the warranty Display Suggested action Black display Power SEN Switch on the main power switch High Temperature Overheating for a Laser changes to standby mode stop temperature is reached failure complet
27. ot suitable for eye protection Suitable glasses are available from your CBN representative Version V2 1 Operating Instructions Nexus 10W Page 4 of 42 Clearly Beautiful Nails LLC clearly nailf Nexus 10W mobile laser ATTENTION Do not stare into the aiming beam or view the aiming beam directly AN through optical instruments Avoid direct exposure to the aiming beam Avoid placing reflective material such as metal and glass into the beam ATTENTION Accidental irradiation to other than the target tissue may result in tissue burn ATTENTION The Nexus 10W is only to be used in combination with a footswitc or handswitch and light delivery systems with the device AN ATTENTION Please avoid touching the patient and the footswitch or handswitdh connector socket simultaneously Note A minimum distance of 25 cm should be maintained between the ventilation slots and walls To prevent the risk of electrical shock do not remove the cover All servicing should be done by CBN or by qualified personnel authorized by CBN After the end of the warranty period sufficiently qualified persons can also do servicing The equipment should be routinely inspected and maintained in accordance with the instructions given in the maintenance section of this manual Disconnect the unit from power supply before cleaning and disinfecting Caution Use controls or adjustments or performing procedures other than those specified in
28. pection of Internal Error Messages ee 6 2 kn E Temperature Indication Inspection via Software Warning In case of any parameters relevant to safety failing the annual maintenance stop using the device immediately Actions taken Version V2 1 Operating Instructions Nexus 10W Page 40 of 42 Clearly Beautiful Nails LLC nailf Nexus 10W rnobile laser BA MAPANA DI on Entry in Instrument i Logbook Inspector AA AA Notes Version V2 1 Operating Instructions Nexus 10W Page 41 of 42
29. sing non authorized application systems Prerequisite for warranty is giving a feedback by using the customer feedback card or Internet Web http www ClearlyBeautifulNails com To make a warranty claim the purchaser shall promptly contact CBN in writing or by telephone following discovery of the basis of the claim During the warranty period CBN in its sole discretion will repair or replace components which are verifiably damaged or malfunctioned In no event shall CBN be liable for direct indirect special incidental or consequential damages whether based on contract tort or any other legal theory For further Information contact CBN Inc 1759 Country Club Drive Cherry Hill New Jersey 08003 TEL 856 354 6105 FAX 866 275 0516 E mail Michael ClearlyBeautifulNails com Version V2 1 Operating Instructions Nexus 10W Page 36 of 42 Clearly Beautiful Nails LLC clearly nailf Nexus 10W rO laser 15 ATTACHMENT 15 1 Device Master Record west C EC meme 1 1 15 2 Training Responsible Name Signature Checked Name of person trained signature Version V2 1 Operating Instructions Nexus 10W Page 37 of 42 Clearly Beautiful Nails LLC clearly nailf Nexus 10W O laser 15 3 Annual Maintenance Protocol Responsible Notes Device Safe No Date status 9 Version V2 1 Operating Instructions Nexus 10W Page 38 of 42 Clearly Beautiful Nails LLC clearly nail Nexus 10W ___
30. this manual may result in hazardous radiation exposure Note IR laser equipment when not in use should be protected against unqualified use by removing the key from the footswitch or handswitch connector 2 Post Market Quality Monitoring CBN maintains procedures that review devices in their post production phase and to Version V2 1 Operating Instructions Nexus 10W Page 5 of 42 Clearly Beautiful Nails LLC clearly nailf Nexus 10W mobile laser implement any necessary corrective action s This medical device vigilance system is designed to improve the protection of the health and safety of patients users and others This is achieved by the evaluation of reported incidents and where appropriate the dissemination of information to prevent repetitions and or alleviate the consequences of adverse incidents Organizations and individuals involved in the purchasing of medical devices and in the provision of healthcare should be aware that their co operation is vital in providing the first link in the vigilance chain This includes organizations and individuals responsible for providing calibration and maintenance of medical devices The following incidents should be reported to CBN immediately upon becoming Known Any malfunction or deterioration in the characteristics and or performance of a device or inadequacy in the labeling or instructions for use which led to or might have led to death or serious injury of a patie
31. ting Instructions Nexus 10W Page 12 of 42 Clearly Beautiful Nails LLC clearly nailf Nexus 10W mobile laser Foot Switch Handpiece Hand Switch 5 2 Labels IR Laser Aperture Version V2 1 Operating Instructions Nexus 10W Page 13 of 42 Clearly Beautiful Nails LLC clearly nailf Nexus 10W obile laser Certification and power rating label Model Nexus 10W 980nm Input Voltage DC26V 4A Danger and Warning IR LASER 980nm 10nm 10W GUIDE LIGHT 635 10nm 4mW max Example Version V2 1 Operating Instructions Nexus 10W Page 14 of 42 Clearly Beautiful Nails LLC clearly nail Nexus 10W rmoblle laseo IR Laser Warning PAY ATTENTION TO ACCOMPANYING DOCUMENTS PROTECTIVE GROUND CONDUCTOR CE ua CE Mark Type B Equipment K Version V2 1 Operating Instructions Nexus 10W Page 15 of 42 Clearly Beautiful Nails LLC clearly nailf Nexus 10W mobile laser 5 3 Description of controls display and connectors Display Display indicates Unit status Ready or standby Treatment mode Continuous Mode Pulse Mode Treatment parameter Energy Pulse Parameter Laser wavelength Laser power setting System message Remaining battery power System status NOTE settings of the unit can be changed using function key or touch screen Function KEY Ready and standby Treatment protocol select UP and Down button Enter Return Set opt
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