Application manual for the C-LAS laser wavelength 10,600 nm

Transcription

1 ENT, Surgery, Aesthetics Application manual for the C-LAS laser wavelength 10,600 nm

2 Bessemerstr Nürnberg phone: fax: WARNING For your own safety follow all guidelines for handling the equipment and follow the safety instructions in this manual A.R.C. Las er GmbH all rights res erved. N ames other here named c arrier c ompanies or produc ts are trademarks theirs res pec tive holder of rights. E very endeavour has been made at guarantee, that all performed informations are ac c urate in this manual. A.R.C. Las er as s ume yet no warranty for the truenes s of the c ontent in this handbook. July

3 CONTENT 1) Laser safety...4 Safety instructions...5 2) Basics of laser application...6 3) Application...8 Indications / Contraindications...8 Technique...8 Alternative application in aesthetics and ENT...9 Waveguide system...10 Assembling...11 Pre-treatment tests...12 Post treatment care...12 Methods in case of unwanted effects...12 Behavior in case of a system error...13 Treatment related issues...13 Treatment parameters...13 Delivery system...14 Applications...16 Page 3 of 20

4 1) Laser safety Laser radiation emitted by the C-LAS laser can cause severe damage to the patient as well as to the user and third persons accompanying the laser use. The C-LAS laser is classified in the laser class IV. This means that the radi ation can cause damage when it is directly applied to any tissue and also if the radiation is scattered or reflected. The C-LAS laser radiation is intense and efficient to evaporate and cut tissue. The most serious injuries occur, when laser radiation is exposed to the eye. Even low laser power is able to damage the cornea of the eye, which is not reversible. This may cause permanent loss of vision. The danger to the eye depends on the wavelength of the radiation and on the dose (energy density per time). Water absorption Laser radiation in the wavelength range between 400 and 1400 nm is the most dangerous for the eye. It penetrates through the aqueous cornea, the anterior chamber, the lens and the posterior chamber and reaches the retina with only little or nearly no absorption. Laser radiation in the wavelength range between 400 and 1400 nm is most dangerous for the eye. The cornea as well as the anterior chamber, the lens and the vitreous body of the eye contain mainly water. The other tissue components (mainly collagen) play a minor role for the laser tissue interaction. Between 400 and 1400 nm wavelength water has very low absorption. Therefore the laser radiation is transmitted very well and nearly the full power reaches the retina, where it is absorbed by the blood and the retinal pigment ephithelium. The C-LAS laser emits infrared laser radiation, therefore it is absolutely necessary to wear eye safety goggles when using the C-LAS laser system. With its intensity (e.g. focused beam), the C-LAS laser radiation can also do harm to skin or other tissue. The radiation can radiation up inflammable material. Page 4 of 20

5 Safety instructions To avoid any injuries it is important to follow the laser safety instructions: 1. Any user of the C-LAS laser system has to be trained by A.R.C. Laser authorized personal or by someone trained by A.R.C. Laser authorized personal. 2. The room / the area, where the laser system is used has to be signed with the laser warning symbols in a way that everyone can easily see that there is a laser area, which should not be entered without the adequate protection while the laser is in use. 3. Do not use the system whenever you are not sure that every component works in the dedicated way. Keep an eye on the fiber delivery: The spot shown by the aiming beam should always be round and defined, no scattering should occur. You may test this by using a radiation paper and holding a bare fiber end in a distance of about 5 cm (you have to put the laser on Ready mode / laser safety goggles!) 4. Whenever the laser is on Ready mode (yellow radiation on) every person within the area where radiation from the laser can occur (laser treatment area/ laser room) has to wear a laser safety goggle which is suitable to protect Ready-LEDs the eyes from C-LAS laser radiation. 5. The laser has to be used only for the defined application; never irradiate any other material / tissue beside the intended use. 6. Special care should be taken to avoid irradiating reflecting materials. Reflected laser radiation can cause the same harm as direct application. 7. Switch off the Ready mode of the laser when the laser is not in use; e.g. during operation breaks or at the end of the surgery. Page 5 of 20

6 2) Basics of laser application The intended effect of the laser application is based on the interaction of the radiation with the tissue components. The laser radiation is absorbed, scattered or reflected by the tissue. Air has only little influence on the C-LAS radiation and therefore the interaction between air and the C-LAS radiation can be neglected. Reflection plays a major role with metal, glass and other reflecting surfaces. When we apply the C-LAS radiation to tissue the reflection is not dominant. Nevertheless it is not zero! When the radiation is scattered in the tissue, it does not influence the absorption. Absorption is mainly responsible for the efficiency of the laser radiation. Absorption means that the C-LAS laser radiation is converted mainly into heat, which causes the desired effects (coagulation/ vaporisation). With low energy density (big laser spot or low power) the heat which is achieved in the tissue can cause heating of the tissue. The smaller the spot size is, or the higher the power is set, the warmer it gets. There is a limit, when the tissue does no longer tolerate the heating, tissue proteins denaturate, coagulation occurs. The next limit is achieved when tissue water (intraand extracellular water) suddenly evaporates (> 300 C). Tissue is fragmented and destroyed. Cutting/ evaporation is achieved. Temperature effect Temperature > 40 C C Effect enzyme induction, membrane disaggregation, edema tissue damage, reversible or irreversible, dependent on the irradiation time > 65 C coagulation > 100 C dehydration > 150 C carbonisation > 300 C vaporization, ablation (removal of tissue) some 1000 C ionisation, immediate burn (shock wave formation) Tissue cutting always needs high energy densities (high power or small spot size). At the cutting edges, respectively beside the evaporation zones the tissue is always affected by the heat (coagulation). The positive effect and advantage of the laser use is that this can stop bleeding from cut vessels (hae mostasis). The negative effect is caused directly at the cutting edge where more than 150 C occur. There is a development of carbonization, created by burned carbon, which is toxic and prolongs the healing of the wound. Page 6 of 20

7 To avoid extended collateral damage (carbonisation and coagulation) at the cutting edges the application mode of the laser can be modified to a pulsed mode, which causes less damage. In continuous mode the laser permanently emits radiation. In pulse mode the tissue can cool down between each laser pulse and therefore the side effects of the heating can be reduced. Page 7 of 20

8 3) Application Indications / Contraindications Surgery indications contraindications vaporisation / ablation / cutting of soft tissue coagulation of blood coagulation / denaturation of collagen / tissue excision of tissue (e. g. tumors) hard tissue treatment (bone,...) application of the beam next to temperature sensitive areas (e. g. nerves in neurosurgery) Technique The C-LAS laser is available with two different delivery systems, the articulated arm and the flexible waveguide. For the articulated arm two different hand pieces are available, with 3 and 5 inch focal distance. 5 inch hand piece The most common use in ENT is with a micromanipulator on the microscope. The micromanipulator is mounted underneath the microscope and guides the beam to the desired treatment area. The micromanipulator is mounted via a footplate which fits to the microscope. Page 8 of 20

9 A similar system is preferably used in gynaecology, where the C-LAS (only with articulated arm) is connected to the colposcope. Alternative application in aesthetics and ENT The C-LAS laser is available with two different delivery systems, the articulated arm and the flexible waveguide. Furthermore, there is a scanner available that can be combined with the waveguide optics for ENT applications and is delivered with the articulated arm for dermatology and aesthetics applications. If the scanner is set out in front of the micromanipulator in the beam and directs the beam in accordance with its programming on the treatment area in the desired form and sequence. Page 9 of 20

10 Waveguide System The waveguide is more flexible than the articulated arm, but is limited in power. In continuous emission mode, the waveguide should not be used with more than 18 Watt. In case of small bending radius of the waveguide this should even be reduced to a lower value, as the transmission in the waveguide drops the smaller the bending radius is. The lower the transmission is, the higher the absorption gets in the waveguide and this can cause damage to the inner lumen of the waveguide transmitting the radiation. As a result of this, the absorption will rise immediately at the damaged area and this leads to a destruction of the fiber delivery IMPORTANT : The waveguide does not transmit red aiming beam radiation. With the UHP hand piece no aiming beam is available. To use the C-Las with waveguide, either hand pieces or an adapter or scanner hand piece are necessary to be connected to the waveguide optic. Direct application is possible via a radiation and small hand piece. The Universal Hand Piece (UHP) system consists of a metall holding hand piece (BG01268) and inserts (ME02264) to deliver the CO2 laser radiation. All components are autoclavable, 134 C. It is only important to achieve a dry inner lumen of the components before use. Page 10 of 20

11 This means, that the user has to make sure that after the sterilization process there is enough time for the parts to dry out or actively dry the material. In case of water inside the insert, which may also result from water in the UHP while positioning the insert, the CO2 laser radiation may be blocked. Be careful handling the insert, the ceramic material is breaking easily. Assembling: To connect the inserts and the UHP the screw-tip of the UHP has to be opened by one or two turns; do not remove the tip from the hand piece. The insert can then be inserted. Do not press, but place the insert into the UHP up to the end position where it stops. After assembling the UHP it can be connected to the waveguide of the laser by the SMA connector. An alternative to the UHP is the focusing hand piece (BG01249), which can be directly connected to the waveguide. This hand piece acts in the same way as the focusing hand pieces with the articulated arm. It focuses the laser beam to a small spot size to cut. On the other side, it is also possible to coagulate, when the hand piece distance to the treatment area is enlarged and therefore the beam size is larger than in the focal plane. This method is called defocusing; the result is a smaller power/ energy density and this leads to coagulation instead of cutting. Note: This hand piece delivers an aiming beam! Page 11 of 20

12 Pre-treatment tests The C-LAS laser does an automatic internal testing on the power output before the device can be used. Keep an eye on the system components. Especially take a look on the waveguide (waveguide version) and hand pieces: the spot shown by the aiming beam should always be round and defined, no scattering should occur (waveguide version only with focusing hand piece). You may test this, by using a radiation paper and watching the aiming beam picture. When doing this, be aware to wear safety googles. Post treatment care Postoperatively, no special care has to be taken regarding the laser treatment. The advantage of the laser treatment is, that in case of surgery the haemostasis effect of the laser treatment is very beneficial for the patient. Conventional care, comparable to standard wound care which would be applied in case of scalpel use and cauterization is advised. Attention: Sutures, which are used to close wounds after surgery have to stay longer than in case of conventional surgery without laser! The haemostasis effect of the laser treatment sradiationly prolongs the wound healing and therefore sutures have to be removed 3 5 days later than normal. Methods in case of unwanted effects The application of laser radiation can cause vaporization of the tissue, which results in tissue fragmentation (cutting): the depth of a cut might get too deep, if the surgeon applies laser radiation at the same position for a too long time. If this happens the wound has to be closed conventionally to the desired amount (suture, etc.). Second, the laser radiation causes haemostasis and the tissue gets coagulated. The amount of irreversible damaged tissue depends on the time and extend of the coagulation. Coagulated tissue is not harmful and does normally not cause any problems. In case of overheating of temperature sensitive areas (e.g. skin) intensive cooling is advised. In case of a big laser spot: When the surgeon has delivered too much energy to the treatment area, the effect is comparable with a burn. Clinical procedures should follow the guidelines for curing burns. Page 12 of 20

13 Behavior in case of a system error In case of any failure in the power generation of the laser, the power which is delivered to the patient decreases. Overpower cannot occur, as the current for the laser tube is limited. Less power than expected results in less effect. When this occurs, the user can check for the beam delivery first and then for the laser. Any damage to the delivery system results in a decrease of the power. A broken waveguide can show a color change at the outside of the waveguide as a result of the heat generated by absorption on the inside. A disalignment in the articulated arm leads to an aiming beam delivery which is non more centered at the end of the arm (note: already small changes not clearly visible can lead to a decrease in power). The user should not continue the use of the laser and contact his local A.R.C. Laser representative. When he checks the laser a restart results in a new check of the system at the beginning. When the laser measures to low or to high power, the system does not start. Any error message displayed by the system can be checked in the manual. In case of any insecurity or questions please contact your local A.R.C. Laser representative. Treatment related issues Discomfort from the heating which is generated by the laser may occur. To avoid this, the user should follow the application parameter guidelines and avoid too long application times. If possible, cooling can reduce patients discomfort after the treatment. All personal, including the patient have to wear eye protection goggles, this may lead to decreased vision regarding contrast and color by the personal and surgeon. In case of any eye injury due to disregard of the eye protection by safety goggles, a clinical center specialized on eye care has to be consulted. Page 13 of 20

14 Treatment parameters Treatment parameters shown in this manual can only be an advice. The data is based on average values generated by our multiple C-Las users. Continuous mode causes more haemostasis and more extended collateral damage (higher effective power, faster, more efficient cutting), pulsed mode reduces collateral damage (less effective power, slower, less efficient cutting). When using pulse mode, the effective power is half of the power in continuous mode (50/50 ratio, on-off). The smaller the beam diameter is, the faster the cutting and the deeper the cut will be. Delivery system: Waveguide optics (WG) Hand piece [HP] / Micromanipulator Power [W] Frequency [Hz] Treatment UHP 3-12 cw cut UHP cut Focusing HP 2-10 cw In focus: cut defocus: coagulation Focusing HP In focus: cut defocus: coagulation (better: cw mode!) Adapter and Micromanipulator 2-8 cw In focus: cut defocus: coagulation Adapter and Micromanipulator In focus: cut defocus: coagulation (better: cw mode!) Page 14 of 20

15 Articulated arm (AA) Hand piece [HP] / Micromanipulator Power [W] Frequency [Hz] Treatment Fokussier-HS 2-30 cw In focus: cut defocus: coagulation Fokussier-HS In focus: cut defocus: coagulation (better: cw mode!) Micromanipulator 2-15 cw In focus: cut defocus: coagulation Micromanipulator In focus: cut defocus: coagulation (better: cw mode!) Page 15 of 20

16 Applications ENT: Cutting and removal/ Vaporization: Laser settings for ENT Power [W] Frequency [Hz] Treatment 5, P1 Cut with spot beam and max. 14 seconds 13, P10 Removal / vaporizing, duration 2.2 seconds 13, P11 Removal / vaporizing, duration 2.2 seconds Delivery system + hand piece Program-Nr. Laser mode Stapedotomy: waveguides Optics + Scanner: Laser settings for stapedotomy Program-Nr. Frequency [Hz] Treatment 20, P2 Stapedotomy 0,3 mm 20, P3 Stapedotomy 0,4 mm 20, P4 Stapedotomy 0,5 mm 20, P5 Stapedotomy 0,6 mm 20, P6 Stapedotomy 0,7 mm 20, P7 Stapedotomy 0,8 mm 20, P8 Stapedotomy 0,9 mm 20, P12 Stapes-supra struktur Delivery system + hand piece Power Lasermode Page 16 of 20

17 Gynecology: Articulated arm + colposcope: Laser settings for gynaecology Hand piece Power (Watt) Frequency (Hz) Treatment colposcope 8-30 CW In focus: cut defocus: coagulation Page 17 of 20

18 Aesthetic/ skin treatments: Articulated arm (AA) or waveguide (WG) + scanner: Laser settings for aesthetic/ skin treatments Power [W] Frequency [Hz] Treatment 25, P1 Lesions removal, Fast removal 25, P2 Lesions removal, Fast removal 25, P3 Small Hypertrophic Grain removal 15, P4 Hypertrophic grain removal with more Haemostasis/ heat 20, P5 Wrinkles of eyelids 25, P6 Skin Resurfacing Facial 20, P7 Grain removal, Facial 20, P8 Perioral wrinkle smoothing 25, P9 Fraxel weak 25, P10 Fraxel middle 25, P11 Fraxel stronge Delivery system + hand piece Program-Nr. Lasermode Page 18 of 20

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