User Manual
Contents
1. and color by the personnel and surgeon In case of any eye injury due to disregard of the eye protection by safety goggles immediate medical attention should be sought POST TREATMENT CARE e Disinfect the hand piece by wiping it after each treatment with a special alcohol containing disinfectant solution Hand pieces should not be used on consecutive patients without disin fecting them first e The neoV laser treatment should not have side effects when applied correctly However the heat generated by the laser radiation may cause patient discomfort Post treatment use cool ing to reduce patient discomfort Please note discomfort may increase if laser treatment is not applied correctly All treatments should therefore follow the above application parameters and guidelines e Insevere cases laser heating can cause burning of the tissue depending on the amount of energy that is applied to the nail This may result in burn wounds which in extreme situations can cause necrosis In case of overheating of temperature sensitive areas cool the area and use other forms of burn treatment neoLaser 2014 13 NAIL FUNGUS AVOIDING REINFECTION Several key steps are recommended to reduce chance of reinfection and increase probability of successful long term outcome These should be communicated to the patients and may include e Exchange regular shoes into new shoes e Place shoes in the freezer overnight to kill any remaining2. fungal infection e Use clean socks on daily basis e Wash socks only at temperatures of gt 60 Cto kill any remaining fungal infection e Use antifungal powder in your socks shoes on daily basis or use of antifungal cream e Wear absorbent socks no synthetic material e After showering dry the feet especially between the toes e Wear well ventilated shoes e Ifyou run frequently spray or powder on daily basis with fungicide The patient should be followed up and examined 4 6 weeks after the last laser treatment to evalua te progress of clear nails In any case of concern regarding outcome an additional laser session identical in nature to the sessions described above should be considered Final outcome and increase in clear nails can be viewed within 9 12 months of first treatment on WARTS BACKGROUND Warts are benign not cancerous skin growths that appear when a virus infects the top layer of the skin Viruses that cause warts are called human papillomavirus HPV You are more likely to get one of these viruses if you cut or damage your skin in some way Wart viruses are contagious Warts can spread by contact with the wart or something that touched the wart Warts that develop on the foot are commonly referred to as plantar warts Plantar warts have these traits e Grow most often on the soles plantar surface of the feet e Can grow in clusters mosaic warts e Often are flat or grow inward walking creat
3. radiation can cause unwanted he LASER RADIATION 8 TEMPERATURE EFFECT TEMPERATURE EFFECT mostasis and coagulation damages The extent strongly depends on the exposure 2006 Enzyme induction membrane time to the laser s radiation eeo en Ee aie Coagulated tissue is not harmful A USS camas Ine verSlO UIE depends on irradiation time and normally will not cause issues In case of overheating of tempera gt 65 C Coagulation ture sensitive areas applying immediate gt 100 C Dehydration cooling should be done and treatment gt 150 C Carbonisation should be stopped and reevaluated A Discomfort from the heating which is generated by the laser may occur To avoid this the user should follow the application parameter guidelines If possible cooling can reduce patient discomfort during and after treatment The neoV laser produces an intense highly directional beam of light If directed reflected or focused upon an object laser light will be partially absorbed raising the temperature of the surface and or the interior of the object potentially causing an alteration or deforma tion of the material and can also cause tissue LASERS SAFETY damage Moreover this beam of light can be hazardous to the eye even when the laser light is reflected from a different surface The energy generated by the neoV1064 laser is in the infrared portion of the electromagnetic spectrum DANGER gt Warning Hazard lab
4. The neov Application Manual e Nail Fungus e Warts Laser 1064 08 18 0 e aa A W neo V LUEGO A European Authorized Representative MEDNET GmbH Borkstr 10 C 48163 Munster GERMANY 1023 DHF 001 R 023 neoV1064 Application Manual CONTENT Lasers Safety o 4 Device Overview 7 Optical Handpieces 9 Nail Fungus PR ee L WALLS eno ena nono ras GSES HRA ee O 2014 neoLaser all rights reserved Names other here named carrier companies or products are trademarks theirs respective holder of rights Any use of the material including reproduction in whole or in part requires permission in writing from neoLaser While every endeavour has been taken by the authors to ensure the information in this document is accurate and up to date neoLaser shall not be liable for any personal damage or injury caused directly or indirectly by solely using this document In case of any doubt please contact neoLaser before using the device O neoLaser 2014 THERAPY INDICATIONS 1 This manual covers various podiatry ap plications approved for use with the neoV laser manual is designed to assist both the beginner and experienced users 2 Clinical information detailed in this man ual is intended to be used by a healthcare professional who posses relevant medical background as well basic knowl
5. ated by authorized personnel only Laser Safety Goggles Laser safety gog gles are crucial for the safety of all persons in the laser use area Make absolutely sure that before turning the laser to READY mode Yellow indicator on user screen and Yellow light on diagonal stripe on top of laser every person in the area that may be impacted by laser radiation is wearing laser safety goggles Make sure that the goggles are suitable for eye protection from the neoV laser radiation see User Manual for further information This includes all persons in the laser treatment area or laser room including patient physician nurse general staff and anyone in the vicinity of the treatment area Training all users ofthe neoV laser system have to be trained by neoLaser authorized personnel or by your trained authorized dealer Laser Warning Symbols laser Warn ing Symbols must be clearly placed in all areas where the laser system is used Laser Operating Area the laser operating area should be clearly marked and sealed while laser is in operation All personnel should be aware when the laser is operating and should not enter the Laser Operating Area without adequate safety protections while the laser is in use System Check before use verify that the system and all its components work as intended Ifthe system does not come up you may try to isolate the problem as explained in the neoV User Manual If prob lem pe
6. dy Yellow Brightness 5 100 Ready to Standby 2min inf Alarm Tone 10 100 Alarm Volume 5 100 Language Screen Brightness 5 100 Go back to Go back button Home page Temperature Humidity System Info Reset Settings Remember Edit Advanced Surgeon Settings Password Settings lin 240ms Pulse Length Power Up Down 1 OO ms Interval Length Control Panel ulse Energy El W Hz 2 94 Display oe AN xY Up Down Buttons Program Name Sta ndby Power Display Control Standby Ready Button The icons and display parameters of the Main Menu are provided in the image above The power setting of the laser is provided in the center of the screen and corresponds to the peak power output from the fiber distal end to the tissue in Watts On the right hand side you may read 1 the Pulse Interval which dictates the length of each pulse or CW for Continuous Wave 2 the Interval Length which dictates the off time between consecutive pulses or SP in case of a Single Pulse transmission 3 the Energy Display which can be toggled to show 4 differ ent parameters of dosage On the top line you may see the current Program selected as well as Home Save and Settings icons On the bottom line you may see the Surgeon selected and the Laser Status indicator on the bottom right hand corner showing whether the laser is in Standby or in Ready mode Changing Parameters You may change the Peak Power set
7. edge with medical lasers 3 Itis strongly advisable to refer to appro priate literature relevant to the intended use If no such literature is available please contact your local neoLaser repre sentative for support LASERS SAFETY 4 Laser parameters values are usually detailed with min max values These parameters were developed based on the extensive use of the device by healthcare professionals 5 The user should always utilize his her ex perience and knowledge as well as clini cal best practice taking into consideration relevant patient information Neither the author nor the manufacturer will be liable for a treatment failure caused by misuse of the device MANAGING UNWANTED EFFECTS Since safety goggles must be worn through out the procedure the operator must be aware that his her vision is temporarily altered col or shades appear differently contrast may be an ophthalmologist hast to be consulted dimmed etc this can lead to visual misjudg ment It is than recommended from time to time to turn off the laser remove the goggles and inspect the treated area without goggles AN In case of any eye injury due to disregard of the eye protection by safety goggles Laser radiation can cause immediate and unwanted tissue damage therefore it is highly advisable to have within reach measures for burn control such as ice or cooling pads topical products spe cial dressings for burns etc Laser
8. els found on the NeoV Laser device Infrared lasers are particularly hazardous since the body s protective blink reflex re sponse is triggered only by visible light In this sense people exposed to high power laser emit ting invisible 1064 nm radiation may not feel pain or notice immediate damage to their eye sight A pop or click noise emanating from the eyeball may be the only indication that retinal damage has occurred i e the retina was heated to over 100 C resulting in localized explosive boiling accompanied by the immediate creation of a permanent blind spot Lasers are categorized and classified into 4 classes ranging from Class 1 to Class 4 The neoV is a Class 4 laser which is the highest and most dangerous class of laser By definition a class 4 laser can burn the skin or cause devas tating and permanent eye damage as a result of direct diffuse or indirect beam viewing These lasers may ignite combustible materials and thus may represent a fire risk These hazards may also apply to indirect or non specular re flections of the beam even from apparently matte surfaces meaning that great care must be taken to control the beam path and to protect the eyes of any person within the laser use area neoLaser 2014 5 LASERS SAFETY BASIC LASER SAFETY INSTRUCTIONS To avoid any injuries it is important to follow the laser safety instructions Operating personnel the neoV laser system can be oper
9. es pressure which causes the warts to grow inward e Can hurt feels like you have pebbles in your shoe e Can have black dots Source American Academy of Dermatology PREREQUISITE e Review User Manual for all safety and sys e Setup laser system fiber and hand piece tem operation topics prior to using the unit per User Manual requirements see also page 12 above for Nail Fungus setup e Ensure all users wear safety goggles per requirements of User Manual and that e This application is applicable to neoV1064 treatment room is properly marked and Part Number LSV1064 20 lasers only protected with up to 20Watts of power PATIENT SETUP e Document the treatment area prior to treatment for clinical reference e Debridement of the area for improved laser e transmission is recommended use disin fected instruments TREATMENT Settings should be e 1mm spot size red focusing hand piece e For skin types I IV e 16 Watts 200 300 msec Pulse On 300 msec Pulse Off total Fluence 200 240 J cm e For skin types V VI 12 Watts 150 250 msec Pulse On 300 msec Pulse Off total Fluence 120 150 J cm POST TREATMENT e Immediate cooling of the area with frozen gel pack may help patient comfort Burn sensation may be felt up to 12 hours post treatment e If blistering occurs wound healing treat ment should be implemented including potential topical antibiotic or soothing ointment e Warts will usually present a black
10. he nails the number of nails to be treated the laser settings the speed of the movement and the tolerance of the specific patient to pain e Apply laser dosage to all nails as to ensure optimal results and avoid reinfection due to untre ated nails e Scan each treated nail at least twice in each treatment session e Scan the laser beam continuously over the nail to ensure uniform deposition of energy on the entire nail surface as well as nail edge and surrounding tissue Move over the nail both in horizontal and vertical movements e Pass over the complete nail including the nail plate nail wall and eponychium e Ifusing HP NF the laser beam should be kept at a distance of 1cm from the nail and with a spot size of 3mm If using HP FOC2 the metal distance setting prongs should be in contact with the nail ensuring spot size of 1mm on the nail e Ifusing a Continuous Scan Mode high pulse rate of 30 pulses per second use HP FOC2 and scan the nail in a uniform speed continuously Do not stop in one spot Keep motion at gt 2mm sec e In using a Discrete Scan Mode low pulse rate of 2 pulses per second use HP NF and move at least half a spot size between consecutive pulses Below are the settings recommended for both techniques The user should choose his preferred technique based on his experience as well as patient preference LASER SETTINGS FOR USERS USING CONTINUOUS SCAN MODE Nail Size Power W Pulse ON m
11. nd has severe risk of liver damage Using the neoV laser allows for effective treatment with no medication NAIL FUNGUS The neoV1064 produces a high intensity laser beam at 1064nm near infrared which goes through the nail penetrates the nail plate heats up the nail bed and destroys the fungus pathogens with minimal pain The heat affects the pathogens by warming the cells des troying the cell walls and thus killing the affected cells The neoV radiation does not have any effect on the nail itself the cuticle or the surrounding skin At the end of the process the nail fungus is eradicated and there is visible increase in nail clearness Nail Root Nail Plate Cuticle Distal edge of Nail Plate Nail Matrix Hyponychium Nail Bed CONTRA INDICATION This treatment is not indicated for e Patients suffering from neuropathy including diabetics with neuropathy e Patients with inflamed tissue around the fungus treatment area e Patients with hyperkeratosis infection SETUP The neoV1064 system should be equipped with a dual connector fiber 400 micron OF WFST400 D and a focusing hand piece HP FOC2 or HP NF depending on physician prefe rence Laser should be operated and fiber and hand piece connected according to User Manual instructions see DHF 001 R 003 neoV User Manual neoLaser 2014 11 NAIL FUNGUS TREATMENT PARAMETERS The duration of the treatment depends on the size of t
12. or crusty appearance within 24 hours a blood blister WARTS Topical and or local anesthetic may be used to increase patient comfort Gel is not to be used Smoke evacuation and laser plume masks highly recommended Treat the entire wart area Make sure pulses overlap slightly Cover the wart area and a 1mm margin around the wart Endpoint Dusky ashen or blanched appea rance to the wart with a halo or round red circle around the edge may form within 7 10 days then crusting and sloughing off within 2 weeks The area should be kept clean patient should use new shoes and socks and wash the area thoroughly More than one treatment may be necessary if wart persists Treatments should be performed 3 4 weeks apart Distributor p E The Product in this Brochure is Not For Sale in the US neoLaser Ha Eshel St 7 3088900 Caesarea Israel e POB 3203 info neo laser com office 972 4 677 9919 e fax 972 4 859 1505
13. rsists contact your local authorized dealer for technical support If any ofthe components are deemed malfunctioning do not use the system and contact your local dealer Fiber Delivery the fiber spot which is illustrated by the aiming beam should always be round and well defined no scat tering should occur Defined Application do not use the laser for any application other than its defined application as stated in this appli cation manual The laser must be used only for the defined application never illumi nate irradiate any other material or tissue besides the intended use Reflected laser radiation reflected laser radiation can cause the same harm as direct application therefore you should make sure to avoid irradiating reflecting materials Standby Mode the neoV laser should be in Standby mode whenever the laser is not in use e g during operation breaks or at the end of the surgery procedure DEVICE OVERVIEW Laser Status light Green standby Yellow ready Red firing Flashing Red error Fiber Port Emergency Button Touch Screen for setting control Cooling inflow Standby Ready button Rear Panel Sockets On Off Button neoLaser Pedal flash drive Door interlock Do not connect unauthorized USB sticks into the unit use only neoLaser supplied sticks o OVERVIEW Volume 5 100 Aiming Beam Brightness 1 100 Aiming Beam Frequency 0 6Hz Rea
14. s Pulse OFF ms Total Energy J Time Sec Small Toe 10 20 10 150 250 20 35 Middle Toe 10 20 10 300 500 45 75 Big Toe 10 20 10 600 800 90 120 LASER SETTINGS FOR USERS USING DISCRETE SCAN MODE Nail Size Power W Pulse ON ms Pulse OFF ms Total Energy J Time Sec Small Toe 10 200 300 150 250 20 35 Middle Toe 10 200 300 300 500 45 75 Big Toe 10 200 300 600 800 90 120 12 NeoV Laser is Trademark of NeoLaser NAIL FUNGUS The patient will feel a heating sensation If this sensation gets too discomforting cease treatment for 5 10 secs If the patient suffers from constant discomfort turn down the power from 10W to 8W or lower If the patient has dark skin it is recommended to consider taking down power as patient skin absorption may be higher due to pigments and therefore result in increased pain sensation Post treatment heating sensation will cease after 1 2hours When applying energy you can choose to view the accumulated energy delivered to the patient or the accumulated number of pulses delivered on main screen below the Pulse On and Pulse Off in terval times see User Manual In either case it is highly recommended to record and document the dosage applied in each session Choosing the Accumulated Energy setting will allow you to view the total dosage applied in Joules Please note all personnel including the patient have to wear eye protection goggles this may lead to decreased vision regarding contrast
15. ting as well as the Pulse Length and Interval Length on the main menu by 1 clicking on the parameter to activate its control and 2 clinking on the cor responding arrows to change it When clicking the parameter it will be highlighted in Green to indicate it may be now changed OPTICAL HANDPIECES Saving Parameters After changing parameters the changes may be stored under the program name by clicking the Save icon on the top right hand side You may notice that once saved the Save icon will become inactive until a change is made Once a parameter is changed the Save icon will again activate to allow saving of the new parameters OPTICAL HANDPIECES The optical hand pieces Blue Red Green and Silver are used for focusing parallelization the laser beam for different applications They work only with the double sided fiber connector OF WFST400 D HP FOC1 HP FOC2 HP FOC3 HP NF OPTICAL HANDPIECES SPOT SIZE Y Handpiece with OF WFST400 D 400um Blue Y 0 5 mm Red 1 0 mm Green Y 2 0 mm Silver Y 3 0 mm OF WFST400 D 400 um User has wide selection of hand pieces to achieve the proper spot size and power density on the target tissue from 0 5 to 3mm neoLaser 2014 9 NAIL FUNGUS Nail fungus onychomyco sis is the most common nail disease impacting 6 8 of the adult population In the past nail fungus was treat ed by medication but this requires months of intake it is expensive a
Download Pdf Manuals
Related Search