RevoLix HTL Content About these instructions for use ....................7 Signal words in these instructions for use ..................7 Precautions and safety information ....................8 Delivery ............................10 Scope of delivery ......................... 10 Product description ........................11 Identification of the model ......................11 General description........................
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RevoLix HTL 4.7.2 Electromagnetic emissions and immunity ................... 27 4.7.3 Electrosurgical interference ......................28 Transport and storage ......................... 28 Functional test before the first commissioning ................28 Laser safety ..........................29 General information ........................29 Safety Distance (NOHD, Nominal Ocular Hazard Distance) ............29 Laser safety eyewear........................
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RevoLix HTL 7.16 Reprocessing of laser fibres, applicators and handpieces ............50 Clinical applications ........................51 Warnings and Precautions ......................51 Laser tissue interactions ......................54 8.2.1 Physical-technical basics ......................54 8.2.2 Physical-medical basics ......................54 8.2.3 Tissue interaction ......................... 56 8.2.4 Laser surgery in a gaseous medium ...................
RevoLix HTL About these instructions for use These instructions for use provide essential information about the safe handling of the laser devices RevoLix HTL, RevoLix HTL cw, and RevoLix HTL eco of the company LISA Laser Products GmbH, Germany (LISA Laser Products). Information and indications relating only to a specific model are marked.
RevoLix HTL Precautions and safety information The following section provides essential safety advice and information. Not following the instructions may injure patients, users, or third parties or damage the laser device. Please also consider the special instructions in other chapters and other related instructions for use. The RevoLix HTL laser device may only be used by persons who have a corresponding medical qualification and have been instructed by LISA Laser Products - considering the instructions for use - in the proper handling.
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RevoLix HTL The laser device must not be disposed of by household waste. Page 9...
RevoLix HTL Delivery Scope of delivery RevoLix HTL laser devices are delivered with the following standard scope of supply: Tab. 1: Standard scope of supply Included items RevoLix HTL Laser Device Door Interlock Dummy Plug (REF 101 600 166) Instructions for use Key (REF 101 610 002) Single-pedal footswitch Kix (REF 101 630 147) Alternatively:...
RevoLix HTL Product description This chapter contains a description of the intended purpose, contraindications and side effects, the user requirements, and controls and features. Identification of the model The model name, the power range (max. power), and the wavelength of the emitted radiation can be found on the type plate (Fig.
RevoLix HTL Intended use / Intended purpose RevoLix HTL is a surgical laser used in CW operation for non-invasive, invasive and surgically invasive incision, excision, resection, removal, evaporation (vaporization) and coagulation of soft tissue in the field of urology. The PULSED operation of the laser is used for the invasive and surgically invasive fragmentation and dusting of stones in the urogenital tract (bladder, ureter, kidney), and for laser enucleation of the prostate.
RevoLix HTL Classification RevoLix HTL is a ‚medical device’ according to the definition of 2017/745 Art. 2 (1) intended to be used for human beings for the treatment of disease. The laser device is categorised into the following classifications and nomenclatures: Tab.
RevoLix HTL 3.10 Controls and indicators The controls and indicators are divided into three areas. They are located at the front (Fig. 1) and back (Fig. 2 and Fig. 3) of the device, as well as attached to the control console (Fig. 6). 3.10.1 Front The fibre holder, fibre connector (fibre coupler), control console, light stripes, laser stop, key switch, footswitch connector, and parking brake are located at the front of the device.
RevoLix HTL 3.10.2 Back The back of the laser device features the type plate, the door interlock connector, the potential equalisation connector, another parking brake, the power cable, and the storage compartment for the footswitch. Door interlock connector Cable winding Vents Potential equalization...
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RevoLix HTL Service Lock for service door door Storage compartment for footswitch Fig. 3: Back (Laser housing with open footswitch storage compartment) Page 16...
RevoLix HTL 3.10.3 Footswitch The footswitch is the control switch for laser emission. If the laser device is in the LASER READY mode, laser radiation can be emitted by pressing the footswitch pedal. Two footswitch versions are available: the Kix single-pedal footswitch and the Kix DUO double-pedal footswitch.
RevoLix HTL 3.10.5 Screen elements The screen in Fig. 7 shows the laser parameters and is subdivided into four areas. Fig. 7: Areas of the touch screen A status bar containing the name of the laser device, the set power (CW) or pulse energy (PULSED), the system status, and a counter for the emitted energy (sums the emitted energy since the last reset [J]) The controls and display elements of the laser parameters of either the single-pedal footswitch...
RevoLix HTL 3.10.7 Status icons The status icons give detailed information about operating states or states of functions of the RevoLix HTL laser device. Tab. 4: Status Icons Icons Function Status Colour Interlock is open Interlock Interlock is closed Green Fibre Fibre is connected Green...
RevoLix HTL 3.10.8 Optical and acoustic signals The different operating states of the laser device can be recognized by various acoustic and optical signals. The laser warning light ribbon around the control console indicates the device’s operating state and the laser emission.
RevoLix HTL 3.10.9 Emergency Laser Stop The laser device is equipped with a laser stop button (laser stop) located at the front of the laser device (Fig. 1). By pressing the laser stop button, the emission of laser radiation interrupts immediately. After the hazardous situation has been cleared, the laser stop can be released by turning it leftwards.
RevoLix HTL 3.12 Fibre holder Rotate the fibre holder [1.] to the desired position and then pass the laser fibre through the fibre holder [2.]. Fibre holder Fig. 11: Fibre holder 3.13 Parking brakes The parking brakes are located at the front and back of the laser device. Each pedal only controls its corresponding pair of wheels.
RevoLix HTL 3.14 Fume extraction systems In open laser surgery, potentially infectious material or cell debris can become airborne via laser fumes. The laser fumes should be extracted as close as possible to the source (recommended filter specification according to IEC/TR 60825-8 – ULPA filter with retention efficiency of at least 99.999 % for particle sizes of at least 0.1 μm).
RevoLix HTL Installation of the laser device The laser device should only be installed by a trained and authorised professional. The installation of the RevoLix HTL laser device needs to meet specific requirements for safety precautions, power supply, and air conditioning. Before operating the laser device, make sure to comply with the regulations for laser equipment and active medical devices and notify the relevant authorities, such as trade associations, responsible for occupational health and safety.
RevoLix HTL Door interlock switch The socket for the door-interlock switch is located at the device’s back (Fig. 2). If the door interlock is interrupted, the laser emission deactivates immediately. After closing the door interlock, the laser device can be operated again by using the ready-slider. If no door interlock is used, plug in the complimentary dummy plug into the free socket to bridge PINs 1 and 3.
RevoLix HTL Electromagnetic Compatibility (EMC) Medical electrical equipment such as the RevoLix HTL laser device is subject to special precautions with regard to EMC and must be put into operation in accordance with the instructions in these instructions for use. 4.7.1 EMC - Operating Environment The use of the RevoLix HTL laser device may only take place in professional healthcare facilities, including clinics, independent surgery centres, operating theatres and endoscopy rooms.
RevoLix HTL 4.7.2 Electromagnetic emissions and immunity The RevoLix HTL laser device complies with the requirements of IEC 60601-1-2:2014 (Electromagnetic disturbances - requirements and tests) and additional standards. In the following, the test methods, classifications and test levels complied with as well as the compliance with basic EMC standards are listed in detail.
RevoLix HTL Tab. 9: Conformity of electromagnetic emissions Basic standard/test Testing requirement Accordance procedure Conducted and radiated emissions CISPR 11:2009 Class A + AMD1:2010 Group 1 Electromagnetic compatibility of CISPR 32:2015 Limits for the specified frequency range for class A multimedia equipment - Emission + AMD1:2019 (1 GHz to 6 GHz)
RevoLix HTL Laser safety The RevoLix HTL laser device emits laser radiation class 4. Irradiation of persons can cause injuries to the skin and eyes. Become familiar with laser safety protections. Laser radiation The working laser emits Class 4 invisible laser radiation. Direct, reflective, or scattered laser radiation can cause severe eye injury and skin burns.
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RevoLix HTL MPE (maximum permissible exposure) 1000 Wm √ − πE NOHD NOHD 4 ⋅ 180 W − 200 ⋅ 10 √ ⋅ 1000 Wm NOHD = 1.19 m 0.403 rad The NOHD (safety distance) for the continuous-wave laser radiation of the RevoLix HTL laser devices is 1.19 m.
RevoLix HTL Laser safety eyewear As soon as the laser device is laser emission ready, all persons present in the area surrounding the laser must wear suitable laser safety eyewear. The laser safety eyewear must have at least the DLB3 protection level for continuous-wave mode laser emission and the ILB3 protection level for pulsed laser emission at the wavelengths of the laser device.
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RevoLix HTL Fig. 14: Warning sign intended for entrance doors to mark laser areas Page 32...
RevoLix HTL Labelling of the laser device The following symbols label the RevoLix HTL laser device and therefore provide the user with important information. The positions of the individual labels can be found in the illustrations in Chapter 6.4.4. Symbols used The following symbols are used on the outside of the laser device: Tab.
RevoLix HTL Type plate - Footswitch The type plate of the footswitch is located at its rear side and contains the necessary information to identify the footswitch. Fig. 16: Type plate of the footswitch (example – Kix DUO) The following symbols are used: Tab.
RevoLix HTL 6.4.3 Labelling of laser radiation The following labels describe the laser radiation and the laser class. The model-specific laser markings are described in Chapter 12.1: Fig. 20: Labelling of the emitted laser radiations (example – RevoLix HTL) Fig. 21: Labelling of the laser class Tab.
RevoLix HTL 6.4.4 Positions of warning signs and labels Labelling of the beam aperture Fig. 22: Labels on the control console Laser Stop Laser radiation labels Type plate Fig. 23: Labels at the front of the device Fig. 24: Labels at the back of the device Page 36...
RevoLix HTL Operation of the laser device This chapter describes how to operate the RevoLix HTL laser device and contains information about the different operating states (STANDBY, LASER READY), operating modes (CW or PULSED), usage of the laser device, and how to configure the laser parameters. Use of controls or adjustments in ways other than those described in this manual may result in hazardous radiation exposure and skin and eye injury.
RevoLix HTL Emission of laser radiation in the wrong operating mode The emission of laser radiation in the wrong operating mode may cause unexpected tissue interaction and result in severe injury and severe thermal tissue damage. • Check the selection of the operating mode (CW / PULSED) before starting the laser emission.
RevoLix HTL 7.3.1 Laser parameters of the operating modes The laser emits continuously with the set parameters as long as the pedal of the footswitch is pressed. In CW mode, only the average power is adjustable. In the PULSED mode, the power, frequency (pulse repetition rate), and pulse effect are adjustable.
RevoLix HTL With the same pulse energy, a short laser pulse removes hard tissue more effectively than a longer laser pulse due to a more substantial impact of the laser pulse on the tissue at higher pulse peak powers. In turn, the coagulating effect of longer laser pulses is better than of short laser pulses.
RevoLix HTL A change in the brightness level of the aiming beam affects both footswitch pedals regardless of which one is currently active. Brightness level adjustment of the aiming beam The brightness of the aiming beam can be set between 0 and 100 % using the "Aiming Beam" selection menu.
RevoLix HTL 7.6.2 Memo menu The “MEMO” menu allows the saving and loading of laser parameter settings. By tapping on the “MEMO” menu button, the following screen image appears. Memory number Laser parameters right pedal Memory name Laser Free memo slot parameters left pedal Fig.
RevoLix HTL Saving of settings The laser parameter settings can be saved by pressing a free memory slot, which can be recognised by a black background (Fig. 35). In case no free memory slot is shown on the page, please scroll the pages until an available one appears.
RevoLix HTL 7.7.2 Connecting a door interlock switch Plug the door interlock switch in its socket at the back of the laser device (Fig. 2). If you are not using a door interlock switch, you must plug the complementary door interlock dummy plug into the available socket.
RevoLix HTL Fig. 39: Start image Testing the laser fibre The following section describes important tests that you must perform before using the laser fibre. Detailed test descriptions can also be found in the respective instructions for use of the laser fibres. •...
RevoLix HTL Absorption of laser radiation in defective fibre connector A defective or dirty fibre connector may heat up. Touching the hot fibre connector may result in burns. Likewise, damage may occur to the coupling optics of the laser device. •...
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RevoLix HTL After connecting the fibre, check if the displayed information, the expiry date, and the power limitations automatically set by the laser device are in compliance with the information given on the fibre label. Absorption of laser radiation in the fibre connector caused by using incompatible laser fibres or exceeding maximum power limits Absorption of laser power in the fibre connector may heat up the fibre connector and may cause burns when touching the hot fibre connector.
RevoLix HTL 7.10 Switching the device to LASER READY operating state Set the desired operating mode and laser parameters as described. For the aiming beam, you should initially choose a brightness level of 100 %. Bring the laser device from the STANDBY to the LASER READY operating state by swiping over the ready-slider with your thumb or finger from left to right.
RevoLix HTL 7.11 Emission of laser radiation Make sure you have selected the correct laser parameters. Insert the distal fibre end into the handpiece/endoscope. To start the laser emission, press the foot pedal. Please note that the footswitch should only be operated by the person who performs the laser intervention. The emission of laser radiation is indicated by the red flashing laser warning light ribbon (laser emission indicator), a signal tone, and the operating state "LASER EMISSION"...
RevoLix HTL 7.15 Cleaning and disinfection Turn off the device and unplug the power plug. Always carry out the cleaning work with activated parking brakes to prevent the device from moving. The laser device and its control console can be cleaned with a soft cloth soaked with cleaning solution. Disinfection can be carried out with an alcohol-free or low-alcoholic surface disinfectant.
RevoLix HTL Clinical applications Please refer to clinical literature, training events, and medical society guidelines on a regular basis for the latest status and recommendations on indications and practices. Warnings and Precautions This section contains warnings and precautions that are applicable to surgical procedures specifically related to the use of the RevoLix HTL laser device.
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RevoLix HTL Perforations caused by laser radiation In all endoscopic and laparoscopic applications there is a risk of perforation. • Always start with low power settings. If necessary, increase the laser power gradually to the required level. • Only trigger the laser emission if the effect of the laser radiation - the distal end of the fibre and the tissue - can be observed.
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RevoLix HTL Improper handling of laser fibres Mechanical damage or excessive bending of the laser fibre as a result of improper handling. At the damaged or excessively curved location of the laser fibre, laser radiation may cause heat to develop, causing tissue damage and burns. •...
RevoLix HTL Laser tissue interactions 8.2.1 Physical-technical basics The RevoLix HTL laser is a diode-pumped solid-state laser (DPSS). The laser radiation is generated by the excitation of a solid-state laser crystal using a laser diode and emitted continuously or pulsed. The emitted laser radiation has a wavelength of 2013 nm (±10 nm).
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RevoLix HTL laser radiation on the tissue decreases. The effect (intensity) of the laser radiation is maximal directly at the beam exit of the laser fibre. The intensity increases with increasing laser power and decreases with increasing distance of the laser fibre tip to the tissue. For cutting and ablation of tissue and for stone disintegration, the laser fibre is used in the "contact”.
RevoLix HTL 8.2.3 Tissue interaction The tissue-ablating effect of the thulium laser is achieved by the immediate heating of water-containing tissue when the laser energy is absorbed. The generated heat leads to tissue coagulation or ablation or stone disintegration depending on the procedure. CW operation The continuous wave laser radiation of the CW operation mode is applied for the treatment of soft tissue.
RevoLix HTL 8.2.4 Laser surgery in a gaseous medium The cooling of the tissue is low when the laser is applied in a gaseous medium, i.e. vaporization occurs as soon as the absorbed power density has reached the ablation threshold. Carbonization is almost inevitable, especially for larger cuts performed during open surgery.
RevoLix HTL Preparation 8.4.1 Handpieces and endoscopes Before the surgery, ensure that the existing laser fibres are compatible with the endoscopes or handpieces to be used. Also, ensure that the laser fibre can be inserted into and pulled out of the endoscope or handpiece without any effort.
RevoLix HTL 8.4.2 Step by step 1. Put the laser device into operation as described in Chapter 7 “Operation of the laser device". 2. Remove the laser fibre from the packaging in accordance with sterile procedures and inspect the laser fibre for damage as described in Chapter 7.8 “Testing the laser ”.
RevoLix HTL 8.5.3 Urology – Indications in CW operating mode The RevoLix HTL laser device is used in the CW operating mode in urology in the following clinical soft- tissue indications: • VapoResection of the prostate (ThuVARP) • VapoEnucleation of the prostate (ThuVEP) •...
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RevoLix HTL The laser light emerges laterally from the laser fibre at a 70° angle. Note that the exit window protrudes from the distal end of the instrument and that the laser beam is not radiating towards the optics. First, insert the shafts with the help of an obturator. Then switch the obturator to the laser cystoscope. Then insert the laser fibre into the instrument, set the laser device to LASER READY and direct the aiming beam at the tissue to be vaporized.
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RevoLix HTL Opening of ureter strictures The opening of ureter strictures is carried out with frontal emitting laser fibres. Use a rigid (or flexible) ureterorenoscope in which the laser fibre is guided through its working channel to the distal end of the instrument. Use a low power setting at the beginning and use the contact-type procedure to perform incisions.
RevoLix HTL Condyloma and penile tumour excisions Condyloma and penile tumour excisions are performed with frontal emitting laser fibres. A special laser handpiece serves as an instrument for the application. The laser fibre is guided via a guide tube to the distal end of the instrument. Use a low power setting at the beginning.
RevoLix HTL Reference values of laser parameters for different applications The treatment parameters in the tables may only be regarded as a guide. The effect of the settings cannot be determined in advance for each case. The settings must be checked individually and adjusted if necessary. Always assess the setting based on the observed laser effects on the target tissue. Start with low power settings and increase if necessary.
RevoLix HTL Accessories The products listed below are standard accessories for use with RevoLix HTL laser devices. In addition, accessories to be used must be indicated as suitable for use with RevoLix HTL laser devices. Please contact LISA Laser Products if you would like to use accessories not listed here together with a RevoLix HTL laser device.
RevoLix HTL Other accessories Tab. 28: Other accessories Product Description Order Number Single-pedal footswitch with connection cable 101 630 147 Kix DUO Double-pedal footswitch with connection cable 101 630 144 Interlock connector Dummy plug for the door interlock socket 101 600 166 Key for the key-switch to turn on the laser devices 101 610 002 Fibre coupler shield...
RevoLix HTL Care and maintenance Maintain and check the laser device regularly. The work described below is a preventive measure to ensure that the RevoLix HTL laser device is always ready for use. Infection risk The laser device and its accessories may be contaminated with biological materials after use and present a potential source of infection.
RevoLix HTL 10.1 Visual and functional check The following tests should be carried out at regular intervals to ensure safe operation of the laser device: Tab. 29: Maintenance/Inspection Schedule Recommended Check frequency Housing parts Monthly Housing parts, handles and doors have no sharp corners and edges or other visible damage. Power and footswitch cables Before each use The cables and their strain reliefs do not show any damage.
RevoLix HTL 10.2 Checking and changing the fibre coupler shield The coupled optics are protected from damage and contamination by a fibre coupler shield (REF 101 610 001). This shield must be checked regularly for damage and contamination. A check is always required if damage to the laser fibre plug has occurred.
RevoLix HTL 10.4 Calibration and verification of laser power The laser device is equipped with a control system that keeps the emitted laser power constant directly in the laser head and monitors it. This ensures that the emitted laser power is in line with the set laser power. The accuracy and conformity of the displayed and emitted laser radiation is part of the periodic safety check, which must be carried out at least annually.
RevoLix HTL Error diagnosis This chapter provides information on how to resolve malfunctions of RevoLix HTL laser devices. The customer service address can be found at the end of this chapter. If a functional fault makes it necessary to carry out service or repair work on the laser device, in order not to endanger your and the safety of your patients, let this work be carried out only by a trained service technician authorized by LISA Laser Products.
RevoLix HTL Fig. 58: Message after fixing the error 11.2 Information messages Information messages indicate special settings or states of the laser device. The messages are hidden after confirmation of the displayed keypad or independently, after changing the state of the laser device. Fig.
RevoLix HTL Technical specifications Tab. 30: Technical specifications Technical Specifications Laser Device Versions Model RevoLix HTL RevoLix HTL cw RevoLix HTL eco Dimensions (H x W x D) 1025 x 450 x 740 mm Weight 108 kg Degree of protection (IEC 60529) IP 20 Mains supply Electrical requirements...
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RevoLix HTL Technical Specifications Laser Device Versions Connectors Interlock Neutrik female connector, type XLR, 4-pin Footswitch Neutrik female connector, type XLR, 7-pin Cooling system Air-Cooling fluid Cooling fluid Deionised water Environmental conditions Operation Air temperature +15 °C - +28 °C +59 °F - +82 °F Rel.
RevoLix HTL 12.1 Model specific laser marking The following markings describe the laser radiation of the various RevoLix HTL versions: Fig. 60: RevoLix HTL Fig. 61: RevoLix HTL cw Fig. 62: RevoLix HTL eco Page 78...
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RevoLix HTL Table of figures Fig. 1: Front ..............................14 Fig. 2: Back ..............................15 Fig. 3: Back (Laser housing with open footswitch storage compartment) ..........16 Fig. 4: Single-pedal footswitch Kix ......................17 Fig. 5: Double-pedal footswitch Kix DUO....................17 Fig.
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