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QUANTUM MOLECULAR RESONANCE GENERATOR INSTRUCTION MANUAL ‘- Vesalius User Manual INDEX 1 INTRODUCTION. 1.1 MODELS COVERED......... 1.2 THEQUANTUM MOLECULAR RESONANCE GENERATOR. 1.2.1 TECHNOLOGICAL PRINCIPLES OF VESALIUS' 1.2.2 CHARACTERISTICS OF VESALIUS” DEVICES 1.3. USAGE TECHNIQUES AND FUNCTIONS: 1.4. USER PROFILE AND ENVIRONMENT OF USE BAAR 2 DEVICE DESCRIPTION. PDT SYMBOLS. ..sssssssestsostosan 2.2. FRONT PANELS DESCRIPTION. 2.3 FRONT PANEL COMMANDS DESCRIPTION 2.3.1. SELECTORS AND PUSH-BUTTONS SECTION, 2.3.2 OUTPUT SECTION esos 2.3.3 FUNCTION SETTING SECTION 2.3.4 REGULATION SECTION. 23.5 VISUALIZATION SECTION. 2.4. REAR PANELS DESCRIPTIO! 24.1 SERIAL NUMBER.. 2.4.2 OPTIONAL... 2.5 REAR PANEL COMMANDS DESCRIPTION. 2.6 STANDARD ACCESSORIES OF THE DEVICES.. 12 12 3. TECHNICAL FEATURES. 3.1 _ INPUTCHARACTERISTICS 3.11 FUSES. 3.2 OUTPUT CHARACTERISTICS. 3.2.1 OUTPUT POWER. 20 3.2.2 OUPUT VOLTAGE.. 2 3.3 POWER DIAGRAMS... 22 3.3.1 POWER OUTPUT DATA 22 3.4 DEVICE FEATURES.. 23 3.4.1 SELF-TEST AT EVERY SWITCHING O} 23 3.4.2 ALARMS. 24 3.4.3. DEFIBRILLATION PROTECTION. at 3.5 CLASSIFICATION ae 3.6 INTENDEDUSt 20 20 24 3.7 ELECTROMAGNETIC COMPATIBILITY, a 3.8 ACCESSORIES FEATURES... #6 4 INSTALLATION, USE AND WARNINGS..... merserrenenemnesernerecnrrernnenenenesnine 2D 4.1 _ USAGE CONDITIONS, TRANSPORT AND STORAGE. 4.2 INSTALLATION OF THE DEVICE 4.3 CONNECTION OF ACCESSORIES. 4.4 INSTRUCTION FOR USE OF NEUTRAL PLATES 4.4.1 SINGLE-USE PLATES... wad INDEX - Vesalius User Manual 4.4.2 REUSABLE PLATES... 45 MEDICAL-SURGICAL INFORMATION 4.6 PREPARATION FORUSE.. 4.6.1 START-UP PROCEDURE .. 4.6.2 SHUTDOWN PROCEDURY 4.7 CAUTION AND WARNINGS. 4.7.1 GENERAL WARNINGS. 4.7.2. RISK OF EXPLOSION AND BURNS 4.7.3 ACTIVE ACCESSORIES .. 4.7.4 _ RISK OF INTERFERENCE. 4.7.5 INSULATION NEUTRAL ELECTRODES. 4,8 SECURITY ACTIONS. ‘5 CLEANING, DISINFECTION AND STERILIZATION .-creosernsroe 5.1 DEVICE CLEAN-UI 5.2 ACCESSORIES CLEAN-UP AND STERILIZATION 5.2.1 CLEANING. 5.2.2 STERILIZATION. 6 MAINTENANCE eo 7 TROUBLESHOOTING rnsenenanninninensnns 8 GUARANTEE... mess sevens sorsenscnnennnnscsrasninenssssssrsesnsastsssninsseassssoces TA ser Manual 4 INTRODUCTION 1,1 MODELS COVERED ees ce: ‘This manual refers to the entire series of Vesalius® Quantum Molecular Resonance generators: CODE | FULL DESCRIPTION DESCRIPTION USED IN THIS MANUAL 2501002| Vesalius® MC MC 2501008| Vesalius® MCN NEUROsurgery | MCN 2501023 | Vesalius® MCNplus MCNplus 2501006 | Vesalius® N1 NEUROsurgery Ni 2501001 | Vesalius® LX80 1X80 2501007| Vesalius® OR1 ORALsurgery ORI 2501019 | QUANTUM QUANTUM 2501026 | Vesalius® LXplus LXplus 2501027| Vesalius® LXplus+RESURFACING | LXplus+RESURF ESONANCE GENERATOR THE QUANTUM MOL! ‘The name Quantum Molecular Resonance comes from the particular way the energy is transferred to the biological tissue in the form ofhigh frequency electrical fields which interact with the tissue itself. Every time energy is delivered to a system, most of itis transformed into heat, which is simply Molecular Kinetic energy. Any type of energy is given from a source to a target through energy packs, better called quanta: they contain an energy value that depends on the source frequency. When these quanta of energy hit the target, in our case the human body, the results are as follows: ‘© ifthe quantum energy value is different from the bond energy of the molecule hit, there is an increase of the molecule’s kinetics energy with no breakage of the bonds, thus resulting in an temperature increase. © ifthe quantum energy value is equal to the bond energy of the molecule hit, then all the energy in the quantum is used to break that bond without increasing the kinetic energy thus without increasing the temperature. In VESALIUS® molecular resonance generator, the transmitted quanta of energy, by selecting the CUT function, reach the tissue with the same energy value of the molecules bonds that compose the tissue. In this way the incident quanta's energy makes the tissue molecule's bonds go in resonance, thus breaking them. Consequently, the temperature increase in the tissue is minimal, since the energy is mainly transferred as a potential energy rather than asa kinetic one. The molecular bonds splitting induce the breakdown of cell membranes (cut effect) reducing considerably the thermal damage. So, unlike other existing technologies, which base their working principle on a sheer transfer of thermal energy (heat is generated by the flowing of electrical current), Quantum Molecular Resonance generators use a spectrum of high frequencies such as to cause a literal “resonance effect” at cellular level. The cutting effect does not depend on an increase of temperature but instead on the braking up of cells due to the induced resonance effect. The incision is light, because the electrode does not go over the cell's necrosis temperature and without causing lateral damage to surrounding tissue (the cut does not need manual pressure coming from the surgeon). The non-traumatic feature of this type of tes nelson (due to burns and surgeon pressure absence) can give many advantages, which had never been reached till now, Best examples are: no trauma, which means no healing tissue caused by an incision with a traditional scalpel; no necrotic tissue, thus resulting in huge advantages for delicate surgeries like Neurosurgery, Spine surgery, ENT, etc; limited bleeding; excellent aesthetic result (not comparable with any other surgical technology); very precise histological examinations; No post-operative pain; very fast post-surgery recovery; reduced intra-operative time; no neuromuscular stimulation; no irrigation required. ia the COAG function is selected in Quantum Molecular Resonance generator, the incident quanta are characterized by an energy foley slightly off resonance. In this way, since the energy is associated to the slightly different energy of molecular bonds tissue, it {allows a modest increase in temperature that triggers the coagulation process through protein denaturation, but stays below the crosis temperature. = of natural coagulation has the great advantage of not collapsing blood vessels, that is the consequence that characterize ia ‘9 or traditional RF generators. rete the coagulation to the cut function, by making the radiofrequency current pulsating, it is possible to achieve better ‘The VESALIUSY (apulaties opened by the incision, are quickly closed, and in has been realised with advanced components and electronic techniques, some of which were purposely designed, ‘Tespect of international norms: the protection systems are double and checked by two microprocessors; the ‘sion currents on the patient, on the wrap and towards the ground are lower than those permitted from the IEC standards, Pag. 5/35, geri for the cut, cut-+ cOnEUInHOn coagulation, the fulguray yor mextto the zone ofoperation. gh frequency and characteristics of insulated jundant an electronic con! to dle, in which the electrodes are insel a ‘The VESALIUS® uses a ham i th the patient in a neutral plate to be putin contact Wi Ts enn ond pale there is not perfect cont 6 Pe a pen wranster tee power to avoid burnings: 1's therefore device. ‘Therefore the Quantum Molecular Resonavit tissue precisely and effectively, ensuring extrem plate all trol of the contact Plate-patient a the que and versatile devices. They allow operating gsue and surrounding structures ON sof ‘SALIUS® are uni enerators VE! aes id respect of the ti e softness an 4121 TECHNOLOGICAL PRINCIPLES OF VESALIUS® : the oscilloscope screen is: Joped by the VESALIUS® when displayed on ‘The energy developes anuous sine-wave in high frequency (cut) (cut + coagulation); 2) ikea continuow lation). b)_likea sine-wave in hig) ©) _likea sine-wave in high mo yh modulated frequency vdulated frequency (coagul rectrode to the right power, according to the surgeon's technique, or ombining ie Macare factors that reduce dehydration and narrowing of tissue, t up on the generator, on the impedance and on the contact area of the elect o iI be lower because of the wide electrode’s circumference andthes, ft iI the applied energy will be higher around the minor reso ‘The best results can be reached combining the most suitable el example, during the incision, spee ‘The speed of the operation depends on the power se : used, For example, with a large electrode the density of energy w! will be a greater dispersion of energy. While, if the electrode is sma © interception and therefore less power will be necessary to obtain the desired result. ; ‘The tieuie's impedance is measured in Ohm ((1) of resistance to the current and is widely variable. When operating ina “humid” tissue, the impedance is low, while an epidermal or a dry weaving tissue have high impedance 122 CHARACTERISTICS OF VESALIUS® DEVICES nerators are intended for cutting and coagulation of tissue during electrosurgical procedures. Tw Quantum Molecular Resonance get pedal activation or, if provided, finger activation) and bipoa, types of handles can be connected to the machine: monopolar (with exceptfor N1 model which has only bipolar functions. All devices are designed to use disposable neutral plates with high insulation, exce s , except for LX80, ORI, Lyi LXplus+RESURFACING models, in which reusable neutral plate is used. ae Each function is independently adjustable, using potentiometers put on the front panel. Each VESALIUS® is equipped with security systems in conformity with international standards for electrosurgical equipments: it ha an emergency circuit that closes the it and sig: i i ve ergenc output and signals with an acoustic and visual device the eventual lack of connection with th: Moreover pneumatic pedal switches are available either of electrical type or pneumatic type, which ones eliminates the disadvanta bar Bost cal sei lectrical i , Whit limit lisadvantage 1.3 USAGE TECHNIQUES AND FUNCTIONS MONOPOLAR FUNCTIONS : ‘he The current, using the “CUT” functi aerate cin i R eaten He heat, and therefore a minimal destruction of the tissue that surrounds he the skin without damaging the tissue the benefits Red ions Pee eee auaia using wire electrodes, its possiiela inc ction it is also possible to take speci a The incision i achieved without exercising mana pressu the electrode with the smallest surface area for that applicat he power must be adapted tothe type of electrode that I al ing ‘an easy cut-flowing. ae eae e power is too high some Ifthe power is too low, the eleecode ea and using di . sing delicate movements, dosing the power in the right way aml 8¥ s being used, in order to be able to cut without originating sparks and be precisi body; the more dehydrated the Sr aes, ited the more The jection ool nae sik the more difficult the ee fhe tissue is, the more easily the current will 6 through intensity of the current necessary to ae operation area can increase et youeueh the body willbe, lytic content of the tissue, reducin One le of the main objectives ‘of the high frequency ‘technic ique herefore™ consists sts in preventing the accumulation of heat. SENG Vesalius User Manual ‘The accumulation of lateral heat depends on various factors, as shown in the following formula: Lateral heat =T *IC * NC * DE time of contact between the electrode and the tissue {cq intensity of the current NC; nature of the current DE: dimension of the electrode [Also the choice of the type of function influences the development of lateral heat: the “CUT” function produces the lowest amount of fateral heating and the minimum tissue damage, while the “CUT-COAG” function produces more heat, because there is also coagulation. To incise with this last function, more power is needed than with the “CUT” function, because there is also the coagulation. ‘The larger the electrode's contact surface is, the higher power has to be used. During the incision, the wire electrode or the curved one must be held keeping the handle ina perpendicular position relative to the tissue to be cut, inserting in the tissue only the wire electrode's tip and 1/3 of the tip in case of curved electrode; penetrating more deeply would provoke greater heat and adhesion of tissue. Itis indispensable to keep the electrode clean from fragments of tissue because these could reduce the effectiveness of the cut. ‘The current, with the CUT-COAG function, beats with a low frequency. This means that a small part of the efficiency of the cutis lost, inchange ofa better coagulation. When the tissue is areolar, a very light film of clot is formed that does not interfere with the normal healing and that spontaneously falls healing is complete. ‘The most effective coagulation (without cut) is obtained choosing function "COAG". ‘The current, with the COAG function supplies an intermittent flow of energy, that is well suitable to obtain the coagulation and highly effective to close blood vessels of diameter up to 1,5mm approximately, avoiding the node. This current is moreover indicated for the indirect technique, because a blood vessel can be coagulated keeping it with a pincette and putting it in contact with the active electrode. It is suggested to perform this by touching the pincette at 2-3cm from the tips and not in proximity of it. To perform the coagulation it is normally used an electrode with a larger contact surface, according to the dimensions of the area that needs to be coagulated. The coagulation is achieved by touching the tissue in an intermittent and light way, without making any pressure on the area, until the bleeding finishes. It is important to maintain the electrode in motion in order to avoid overheating of the tissue. ‘The coagulation is obtained when a white appears on the tissue; the lighter the tissue is touched, the more evident the coagulation effect is. ‘Too much high power provokes a greater destruction of the tissue around the electrode; in this case it is suggested to diminish the power or sliding the electrode faster. This function is also used, with right electrodes and in low power, for epilating and telangiectasias. Fulguration The fulguration is obtained choosing the "FULGURATE" function, which produces a powerful dehydrating effect, even if its destruction capacity is self-limited because of the insulator effect of the carbonated superficial tissue that prevents the destruction by heataccumulation on the tissue underneath. Therefore with this function a superficial destruction of the cells is obtained. Superficial keratosis and warts can be cured if this function is used in low power. Generally a needle electrode with a large tip is used, and it withstands the power distributed by the device and the consequent heat generated. The electrode must be held at a distance of approximately 1mm from the surface to operate. N.B: To activate the FULGURATE function it is necessary to connect the handle to the appropriate socket n.20, on the front panel of the generator. This function is enabled only when used with FOOTSWITCH handles (only activated by pedal). However, if you are using a FINGERSWITCH handle, it is possible to connect it to n. 20 socket, as long as you use the blue pedal and select FOOTSWITCH to activate the VESALIUS®. ‘Treatment Resurfacing is achieved by choosing the "RESURFACING" function, and is used on the face and neck with the purpose both ‘o make the skin smooth and polished and to induce a process of cellular regeneration at a basal lamina level. The therapy is also Used in other parts of the body such as thighs, gluteus and abdomen, mainly as a treatment for reducing stretch marks or scars. With this function therefore a superficial destruction of cells is achieved. With this function the Resurfacing handle (code 2502017) is used, and itis combined with the particular electrode for Resurfacing (code 2607002). The electrode must be placed against the skin with light pressure, avoiding both excessive pressure and a light touch of the skin. The treatment lasts approximately 10 minutes. It Must be set to a power such that the "sparkle" is not uncomfortable for the patient. N.B; To enable the RESURFACING function it is necessary to connect the handle for Resurfacing to the socket 31 on the front panel of nt. This feature is only enabled to the use of handles driven by the pedal. Pag. 7/35 an using bipolar forceps with a contact area as small as Cutand cut-coag ran Po ea ly setting the powel e 5 also Ossie vB cutting Pama aac es anual pressure due to the fact that these functions also contain a percentage achieves a delicate cut, 4 ound the edges of the incision will be seen. Ifthe power is top jy, coagulation. : some sparks and a discoloration aro : biceps not Pret and tissue fragments will remain a bipolar forceps will not be able to cu vi ‘The tissue must be cut with a linear motion and with a slight pressure movement must be fast, as much time as the forceps ey i conte a eee .d by slight warming is. The incision will be clear and free of ¢ ree ales at ii paer is good for cutting soft tissue and small vessels coagulated, Ed pe Power is ideal for sng incisions and excision of tissues, while at high power itis effective and fast inall penance or pisnd hard tissues i in order to cut without sparki antes) fee ‘The power to be used should be appropriate to the application in or ‘The scale of powers was designed so that in is first half the variation is minimal, ene ae good resolution; this party, scale is ideal for delicate tissues; in the second half it presents a more sensitive variation and therefore it is suitable for other typ, tached to the forceps. e of the bipolar forceps around the section to be eye the tissue during the incision, the greater the discoloration ation tissue. ‘These bipolar functions are available only on VESALIUS® MCNplus and N1 models. Coagulation a 5 With this technique it is possible to close vessels of approximately 1,5mm of diameter without creating eschars and limi therefore the risk of post-operative bleeding. N.B.: In order to obtain the best result with all the functions it is important to follow the following procedure: activate ts VESALIUS® (pressing the pedal or the relative push-button of the function chosen), then operate on the tissue, and in the end sts off the VESALIUS®, A ‘THE FUNCTIONAL CHARACTERISTICS ARE GUARANTEED ONLY IF ORIGINAL ACCESSORIES ARE USED. 14 _USER PROFILE AND ENVIRONMENT OF USE The medi ae z ie peace Vesa js an invasive active device in compliance with requirements for the category of high feqiet micas oe the meeede mane Tenens perce personel trained in the particular technique and surgical procedure. Te ee ssential to achieve the maximum benefits from Quantum Molecular Resorat The Vesalius® devi raquitenens pas ee witht a suitable healthcare environment (operating room, medical clinic, etc.) in compliance wit scarey onmental (temperature and humidity) and electromagnetic conditions listed below. ‘The expected positions of the o} ie patient, by an operation: any electrosutg : )perator and the pat PE . pot F it, by. al point of view, are common to those of any electrosurgid REV. 1.5 2 DEVICE DESCRIPTION 2.1 SYMBOLS er Manual hhis section is explained the meaning of the symbols used on the device and on plate labels in accordance with international In this sectior standards: Io ion-proof type CF applied Stand-by eS Follow instructions for use A Caution See F HP isolated patient circuit Za Keep away from sunlight CUT function Alternating Current COAG function Make reference to the WEEE directive FULGURATE function Catalogue number RESURFACING function Batch code Footswitch mode Serial number Fingerswitch mode Rotating knob changer Bipolar mode a Keep dry Time mode Temperature limitation Neutral plate Use by 4X Plate detachment Do not reuse European Community mark Sterilized using ethylene oxide Equipotentiality Non-sterile Not ionizing radiations Latex Free Fuse Read user manual Manufacturer REV. 1.5 Vesalius User Manual _ENG 2.2 _ FRONT PANELS DESCRIPTION é eaib etn agree Vesalius® MC Teles) creer} eee Vesalius (2 = oot | @ : EB iG = Go oes! io [moe =e Vesalius” Vesalius® LX80 [e+ a Teles] | | a) |= | Vesalius® Vesalius® OR1 at ORALsurgery 1 Teles) oe QUANTUM tw) 1 ol 4 gegg Se So= i las Vesalius® LXplus TT end fesalius® LXplus+ RESURF REM Pag. 11/35 1 LUMINOUSSWITCHON/OTE 2 PUS-BUTTON TOSELECTAFUNCTION 3 PUSHBUTTON TO SELECT THE CUT FUNCTION es al a ‘PUSH-BUTTON TO SE “THE CUT-COAGULATION FUNCTION ONTO SELECT THE COAGULATION FUNCTION __—__— 5 T ere 6 ear aaaegrr raeroucuparemiMCN Se eee 7 SS 8 pus UTTOW TOSELECT THE FINGERSWTH 9 U-AUTTON TO SELECT TE BIPOLAR FINGTION POWER OUTPUT 10 KNOB FOR CUT OR CUT/COAGULATION, iL KNOB FOR COAGULATION, FULGURATE, BIPOLAR POWER OUTPUT OT {UT/COAGULATION a 12 DISPLAY REFERRING THE KNOB POSITION FOR CUT, Ct 13 ‘DISPLAY REFERRING THE KNOB POSITION FOR. “COAGULATION, FULGURATE, BIPOLAR, 14 ‘LUMINOUS DIODE INDICATING THE CUT OR. CUT/COAGULATION OPERATION 15 TNTNOUS DIODE INDICATING THE COAGULATION, FULGURATE, BIPOLAR OPERATION =] 16 [LUMINOUS DIODE INDICATING THE STATE OF FAULT Zan 17 LUMINOUS DIODE INDICATING THE SEPARATION OF THE PLATE ae 18 ‘LUMINOUS DIODE INDICATING EXCESSIVE LEAKAGE CURRENTS. 19 LOGON CONNECTOR FOR MONOPOLAR HANDLE: CUT, CUT/COAG, COAG 20 LOGON CONNECTOR FOR MONOPOLAR HANDLE FOR FULGURATION OUTPUT ONLY 21 ‘LOGON CONNECTOR FOR THE ISOLATED PLATE HIPOLAR LOGON CONNECTOR Og Peeeni One Meena PUSHI-BUTTON TO SELECT THE RESURFACING FUNCTION. LOGON CONNECTOR FOR MONOPOLAR HANDLE FOR RESURFACING. CS Pane ‘CONNECTOR FOR THE ISOLATED PLATE OR BIPOLAR CABLE. KNOB FOR CUT OR CUT/ COAGULATION POWER OUTPUT POTENTIOMETER FOR TIMER REGULATION PUSH-BUTTON TO SELECT THE TIMED FUNCTION mlolole|> DISPLAY REFERRING THE POTENTIOMETER POSITION FOR TIMER REGULATION PUSH-BUTTON TO SELECT-THE IMPEDANCE CONTROL FUNCTION Zoe FRONT PANEL COMMANDS DESCRIPTION ‘The panel board can be divided in four sections: selectors and push-buttons section; output section; regulation section; visualization section. 23.1 SELECTORS AND PUSH-BUTTONS SECTION Switchi =a coe fe Sartng switch button (1) in ON position the device within the setting feo network, the displays (if available), the Uf Sealed eee and the FAULT LED (16) light on, While these Le? chee Reo executes control test of electronic circulls " aa inctioning; if only the FAULT LED keeps enlighte" OFF in anomaly of the syste I it ine yystem. To re-enable the machine function!"8' Hy to press the button SET (2) to make the test again. - REV.1.5 SET push-buttons To choose a function it’s necessary to press every time button SET (2) and than the one related to the desired function (push-buttons 3, 4, 5, 6). This button restore the normal functioning after a FAULT signal, reactivating Models Models the self-test starting. Mc 1X80, MCN, ORL, N1 QUANTUM, MeNplus CUT, COAG, CUT/COAG, FULGURATE push-buttons cll Models QUANTUM, MCNplus Models MC, LX80 Goer 7 CoN} ae Models MCN, OR1 coas MICRO Model Ni fey. Models LXplus e LXplus+RESURFACING These are push-buttons to choose the desired function. The push-buttons CUT (3) e CUT-COAG (4) are not interdependent: inserting a function disconnects the other. Equally push-buttons COAG (5) and FULGURATE (6) are interdependent too. The function RESURFACING (30) is selectable all alone, therefore it is not selectable simultaneously with another function. To modify a function choice, it is always necessary to press first button n.2 (SET) (except for LXplus and LXplus+RESURFACING models in which there is no such button, but the functions are available directly), then the one corresponding to the desired function. The LED on the function buttons are yellow for CUT and CUT-COAG while they are blue for COAG, FULGURATE and RESURFACING, in conform to the safety norms IEC 60601-1; the same colours have also been adopted for the buttons. N.B: To activate the function FULGURATE it is essential to connect the handle to the special socket (20) positioned on the front panel-board, This function is enabled only for use with handles commanded by pedal only. However, if you have been using a handle with FINGERSWITCH, it's possible to connect it to the n.20 socket, as long as you use the blue pedal to activate the device. ‘0 activate the function RESURFACING it is essential to connect the special handle for RESURFACING (code 2502017) to the special socket (31) positioned on the front panel-board. This function is enabled only for use with special handle commanded by | bedal only. Push-button to select the timed mode Button TIMED (D) activates the timing of the output power according to the selected function. To disable it, push again the button. The activation of this function is indicated by the green LED. Models LXplus, LXplus+ RESURFACING Pressing the I.C. push-button, impedance control is activated and it warns through an acoustic signal when coagulation has occurred. Re EV. 1s Pag. 13/35. Vesalius User Manual Push buttons to select the operating mode 2 < 0 Models MC MCN, LX80 FI f aie aoe Ta . . Model OR iol lead atid cf Model QUANTUM GS Model MCNplus S Models LXplus, LXplus+RESURFACING To select the FOOTSWITCH-handle it is necessary to press the FOOTSWITCH button (7). To select the FINGERSWITCH handle itis necessary to press the FINGERSWITCH button (8). To select the bipolar switch handle it is necessary to press the button BIPOLAR (3). For what concerns the QUANTUM model the button (7) indicates the activation of the monopolar function that can be activated with the pedal. Pressing it again the function is disabled. FOOTSWITCH and FINGERSWITCH buttons are interdependent, inserting a {function disconnects the other. BIPOLAR button is independent. Also in these buttons the relative green LED lights on to indicate that | the selected output has been connected. To activate the BIPOLAR function it is necessary to activate BIPOLAR button which automatically activates the COAG function. Q2@ QA.@QB N.B:: In VESALIUS® the output power is activated at the selected output only by pushing the pedal or the finger handle, and only after the selection of output and function. | N.B.: To activate BIPOLAR function, for LX80, LXplus and LXplus+RESURFACING models, it's necessary to select COAG (SET+COAG) {function and then select the operating mode BIPOLAR with the proper button (except for LXplus and LXplus+RESURFACING models in which there is no SET button (2), but the functions are available directly). 23.2 OUTPUTSECTION ‘The available outputs are correlated to the available operating mode upon the VESALIUS®. The outputs are divided in three sections: * MONOPOLAR; © NEUTRAL; * BIPOLAR. Vesaliu ser Manual PRIMARY SURGERY /ACTIVE and FULGURATE connectors Models MCN, MCNplus resunracine ‘Models LXplus, LXplus+ RESURFACING ‘The MONOPOLAR output is simply detectable on the frontal panel in "PRIMARY SURGERY” or “ACTIVE” sections, and, if present, in “FULGURATE"” and “RESURFACING” section. This output is available both for the operating mode FOOTSWITCH and FINGERSWITCH. In case you use the pedal switch handle it is necessary connect the monopolar adapter to the output behind the connector (19), whereas for finger handle it is necessary to insert the plug into the relative connector on panel (19). This output, for QUANTUM models, is identified by “MONOPOLAR" writing, this device is available only in FOOTSWITCH operating mode. When the functions CUT, CUT/COAG or COAG are chosen, the handle must be connected to the connector n.19 (PRIMARY SURGERY); function activation is executed with double FOOTSWITCH handle or with FINGERSWITCH handle; when the FULGURATE function is chosen the handle needs to be connected to the connector n.20 (FULGURATE) and function activation is executed with blue pedal. The FULGURATE output is made operative only when the function FULGURATE is chosen (6) When the RESURFACING function is chosen the handle needs to be connected to the connector (31) and function activation is executed with single pedal. The RESURFACING output is made operative only when the function RESURFACING is chosen (30). N.B.: To activate the function FULGURATE it is essential to connect the handle to the special socket n.20 positioned on the front panel board. This function is enabled only for use with handles commanded by pedal only. Model OR1 However, if you have been using a handle with FINGERSWITCH, it is possible to connected it to the n.20 socket, as long as you use the blue pedal to activate the VESALIUS®. N.B.: To activate the function RESURFACING it is essential to connect the handle 2502017 to the special socket 31 positioned on the front panel board. This function is enabled only in LXplus+RESURFACING model and ‘Model QUANTUM for use with handles commanded by pedal only. N.B.: Monopolar output is not available in N1 model. NEUTRAL connector ‘a NEUTRAL, Models QUANTUM, LX80 € ORI Models MC, MCN, McNplus, LXplus, LXplus+RESURFACING ‘The NEUTRAL connector (21) is used to connect the plate, necessary for the use of the monopolar handle activated by pedal or by finger. N.B.; In the N1 model the NEUTRAL connector is not available, because this device allows BIPOLAR functioning only. Pog. 15/35, yal BIPOLAR connector ae | sed for BIPOLAR operating mode r functions i i to a third pipolar functions is obtained thanks Peete rial iereoeraeat from the double one. There is, therefore, the | Pnewmity to employ both the techniques during the same operation | Prekout modlffing the previous formulation made on the panel-board. To | eaan ct the bipolar handle, the connector indicated with BIPOLAR must to | be used. LAR function, for devices that are provided, it is, OAG (SET+COAG) function and then select the | de with the proper button (except for LXplus and | ‘The BIPOLAR output (22) is u Models MC, N.B:. To activate BIPO! necessary to select C BIPOLAR operating mo 7 LXplus+RESURFACING models in whi functions are available directly). ich there is no SET button (2), but the Models QUANTUM, LX80 € ORL 2.3.3 FUNCTION SETTING SECTION The regulation section and the setting of the fun monopolar mode, and on the type of actuator yor and function setting of each device are illustrated on the Quick Instruction Ma tions is variable and depends on the VESALIUS®, generator model, on bipolar or 1u want to use (fingerswitch/footswitch handle or pedal). The steps for activation nual VESALIUS®. 23.4 REGULATION SECTION The regulation section is composed of turning potentiometers with numerical indication on the display. The numerical indication is not present on LX80, OR1, QUANTUM, LXplus and LXplus+RESURFACING models. By rotating the potentiometers clockwise the power output increases. Potentiometer CUT/CUT-COAG (10): The potentiometer CUT/CUT-COAG (on the left) is to vary the output power for the function CUT and CUT-COAG. Potentiometer COAG/FULGURATE/ BIPOLAR (11): The potentiometer COAG- FULGURATE- BIPOLAR (on the right) is to vary the output power for the function COAG, FULGURATE e BIPOLAR. Potentiometer POWER (B): The potentiometer POWER regulates the output power for the selected function on the Vesalius® LX80, OR1 and QUANTUM models. Potentiometer TIME (C): The potentiometer TIME is to vary the activation time of the output power of the function set up. When the time, that has been set, is over the machine stops until a new activation is done by the user. This regulation has a band that indicates the increasing of the time (from 0,01 to 0,99 seconds) by rotating it clockwise. 2.3.5 VISUALIZATION SECTION Display CUT/CUT-COAG (12) and COAG/FULGURATE/BIPOLAR (13): Itprovides a numerical indication of the power delivered on each position of the potentiometer for all functions selected, Display TIME (E): Itindicates the increasing of the time (from 0,01 to 0,99 seconds). The indication refers to the effective output time. Yellow LED CUT (14): Itindicates the output power in CUT, CUT-COAG mode, It flashes when high currents are absorbed by the power stage. It flashes when high currents occur due to a decrease in impedance. In case the LED flashes concurr Is over 10% of the value shown by the technical data on the label. Se eevee Blue LED COAG (15): Itindicates the output power in COAG, FULGURATE, BIPOLAR and RESURFACING 5 5 mode. It flashes when hi its are absorbed by the power stage. It flashes when high currents occur due to a decrease in impedance. In case the LED ee with the LED CUT (14) the voltage is over 10% of the value shown by technical data on the label, FAULT LED (16): Indicates a malfunction during starting power or system anomalies. It shows a crash in case of overheating of the power stage. REV.1.5 Pag.16/3" Red LED (17): itsignals that the neutral plate is not properly connected (the LED flashes together to an intermittent sound). This alarm deactivates the output, the equipment does NOT output power and in these conditions it does not work. 24 REAR PANELS DESCRIPTION REAR PANEL Vesalius® MC Zo 20) 27 Vesalius® MCN 28 NEUROsurgery Vesalius® MCNplus 24 29 23 ( ) | 28 25 26 cn Vesalius® N41 NEUROsurgery 24 29 23 ( ) Vesalius® LX80 QUANTUM G 28 Vesalius® OR1 | ORALsurgery Vesalius® LXplus eae 24 29 Vesalius® LXplus+ 23 G ) | RESURFACING i 23 POTENTIOMETER TO REGULATE THE VOLUME 24 LABEL WITH TECHNICAL DATA 25 CONNECTION FOR PNEUMATIC DOUBLE PEDAL, BUSH FOR CUT, CUT-COAGULATION 26 CONNECTION FOR PNEUMATIC DOUBLE PEDAL, BUSH FOR COAGULATION, FULGURATION 27 CONNECTION FOR PNEUMATIC SINGLE PEDAL FOR BIPOLAR FUNCTION 28 MAINS SOCKET CONTAINING N. 02 FUSES 29 EQUIPOTENTIAL NODE TOWARDS THE GROUND G CONNECTION FOR PNEUMATICSINGLE PEDAL Rev Pag. 17/35 ee —ENG tion that are necessary to our internal quality rma : t pumbers and contains some internal NOPE ATT ther amendments (EC/2007/47), 1g ropean Di ised as follows: 2.4.1 SERIAL NUMBER 9 || number is characterised by in a Aerie In order to be conformed to tne ee yranufacturing date is visibly shown on another label. [tis MM/YYYY ee mization present in the specific equipment. This felg fs " S" field on the label plate are showed the details of custom/7=000 pene eee E eee Ariat number of letters, from a minimum of zero up to a maxim consists o| three lett 2501002 XXX B09010101 ‘The first X identifies the supply voltage, the second X Identifies the presence of electric or pneumatic pee the third X identifies the presence of control impedance board. The meaning of each letter is explained in the following legend: es tvounaly) Noletter voltage No _ impedance letter Pneumatic pedals Noletter coatral eae Nole 115V Supply voltage 100V Supply voltage Impedance control Beas board is installed 115/230V Supply voltage ‘The standard version consists of a device supplied with 230V with pneumatic pedals and without impedance control board, then this version will have an empty OPTIONS field. ‘The indication of the supply voltage is also shown in the label underneath the mains socket to which is connected the power cord, __ REAR PANEL COMMANDS DESCRIPTION ‘The connectors (25) and (26) are respectively for the function cut guarantee the not interchangeable there is a brass output with hol double pedal must be connected to the output (25) for the pedal o: correct watertight connection there isa lock tapping ring nut. (or cut-coagulate) and for the coagulation (or fulguration). T° les of different diameter; the pipe coming from the pneumatic mn the left and to (26) for the pedal on the right. To ensure the ‘The third single pedal must be connected to the connector 1X80, QUANTUM, OR1, LXplus and LXplus+RESURFACIN inserting the pipe by pressure. (27) (BIPOLAR) by simply inserting the pipe by pressure. For mode! G the single pedal must be connected to the connector (G) by simp!) The potentiometer (23) regulates the sonorous intensity of the two output activation tone. Labelling and electrical safety: The label 24) contains the data described by IEC 60601-1 series of standards, Th Seer afcsedhct (25) hee in The terminal (29) is the Equipotential node. anufactaren nt Co) Bas two protection fuses from the network inside it and must be Conese geo the cable furnished by th REVAL pes tl lius User Manual Ves 6 STANDARD ACCESSORIES OF THE DEVICE ‘the following standard accessories are for guidance only. Always refer to the Catalogues VESALIUS® Accessories and QUANTUM Accessories for a complete list of all the different applied parts that can be connected to Quantum Molecular Resonance generators. cz ‘STANDARD ACCESSORIES L—- ' a ee Description code eee ese = 8 |g : : a = 3 o $_| single-use insulated neutral plate | 2503003 |X x x 1] Adapter for single-use plates 2505006A |_X x x 1_| Footswitch handle 2502001 | _X x x x x x 1_| Fingerswitch handle 2502003 x 1_| Standard electrodes set 2601001 |X x x x x 1_| European bipolar connector 2506001A |_X 1_|2pin american bipolar connector | 25060044 x x x 1_| Single pneumatic pedal 2504006 |X x x x x x x 1_| Non-skid double pneumaticpedal | 2504003 |X x © E 1_| Reusableinsulated neutral plate | 2503001 x x x X 1_| Blectrodes set for oral surgery 2601005 X a sae electrodes set for Tesibay ? T_| Handle for RESURFACING 2502017 x 70 _| Electrodes for RESURFACING 2607002 x Each device is then accompanied by the power cord according to the buyer's country and the instruction manual in multi-language version. Pag. 19/35. 3 TECHNICAL FEATURES 1 INPUT CHARACTERISTICS Toov or 115 V or 230V* ~ 50/60Hz S5OVA (350VA only for N1 model) Supply voltage Plectrical input power from the supply mains i tion to a specif y voltages but is designed to allow connec' se Se refer to the voltage value indicated inthe abel postion * Caution: The unit is not equipped with a s for the appropriate value for the specific device. supply mains with a single nominal voltage of under mains socket in the back of the equipment 3.1 FUSES ‘The mains socket (28) has an accessible fuse housing which contains two fuses wid = type 3,15A and low breaking capacity for 230V supply mains; © type 8A and low breaking capacity for 100V and 115V supply mains; © type T 6A and low breaking capacity for 100V and 115V supply mains (only for N1 model) hh the following features: In case of breakage it is recommended the replacement with similar fuses of same type and full rating (voltage, current, operating speed and breaking capacity). 3.2__ OUTPUT CHARACTERISTICS _ Allspecifications are nominal and subject to change without noticing. Each parameter listed should be considered with a tolerance of +£20% from the nominal value, considering an ambient temperature of 25°C and a supply voltage from mains equal to the value shown on the label located under the mains socket. 3.2.1 OUTPUT POWER Output frequency | spectrum of quantized high frequencies The following values of rated output power [W] refer to the nominal load [Q] and correspond to those ones listed on the label located on the rear panel of the device. Particular care shall be taken to ensure accuracy and safety during measurement of high frequency output. In order to reproduce these values it's necessary to follow requirements listed in the technical standard for the specific environment and to use suitable instruments. - MAXIMUM OUTPUT POWER [w/Q) Function g g 2 | é je E 5 i @ - a : 160/400 | 120/400 | 120/300 / 120/400 | 120/400 | 120/400 | 120/400 | 120/400 140/400 | 110/40 / 400 | 320/400 / 100/400 | 100/400 | 100/400 | 100/400 | 100/400 100/400 | 80/400 | 100/300 a 70/400 70/400 70/400 80/400 80/400 / / 120/100 / if 2 ie fs 1 / i 130/100 l / / / / / 1 / 70/100 I / / / / / 20/700 snes ree | vanm_| pp eee fap : A : L 60/100 60/100 60/100 60/100 20/100 | i a 7 i / 7 70/200 7 7 7 f see 1 / / 25/100 i / ; : a £ i REVS QUPUT VOLTAGE 3.2.2 ‘The highest output voltage for each high frequency surgical mode is, on average, as follows: Ee MAXIMUM OUTPUT VOLTAGE (vl a z ’ g g S 3 8 2 a Function = g s g z z : 3 = o ee eae) 407 400 f 530 404 398 415 417 renal) 963 513 650 i 707 555 S54 564 566 aia %°° 890 920 / 850 01 73 956 970 cor bipolar a / 250 / / / / / / COAG eo) / / 835 / / i 1 / / COAG bipolar is / 800 / / L hy Z i ruucurate | 910 7 7 7 aaa 1 i a BIPOLAR 407 398 800 il: 323 280 268 291 290 BEUEAONG / / / 1 / 769 MICROCUT 7 7 7 354 Z L Z / / MICROCOAG i / L 520 if L i if / Warning: Associated equipment and active accessories should be selected as to have a rated voltage equal or greater than the maximum output voltage shown above. The use of original accessories assures the functional performance of Quantum Molecular Resonance generators VESALIUS®, Pag. 21/35 . ENG Vesalius User Manual 3.3. POWER DIAGRAMS 33.1 POWEROUTPUT DATA ng ata specified load resistance. These diagrams ‘The following diagrams show the power output versus approximate. Please refer to the Test Report (Form 10-02; the output control setti ) for the quantitative curves. MCN NI NEUROSURGERY ms showing the power output at full and half output control settings over the range of load resistance from 102 up to 20000 ra x Poemonopolar output and from 102 up to 10002 for bipolar output are included on the Test Report (Form 10-02), which accompany the device. 3.4 DEVICE FEATURES VESALIUS® Dimensions im ae rH al Tal | | wom | 410mm | 410mm | 410mm | 340mm | 340mm | 340mm | 340mm [340mm | 340mm HeGHT 170mm 170mm 170mm. 170mm 170mm 170mm 170mm, 170mm 170mm pam | 320mm [320mm | 320mm | 320mm | 320mm | 320mm | 320mm | 320mm | 320mm waar | 142k 14.2ke 14.2kg 13.5kg 13.5kq 13.5kg 13.5kg 13.5ke 13.5kg VESALIUS® device's characteristics: 341 Every time the device is switched on, Simulates some breakdowns in order to verify the correct p: and all the 7 LED display segments are on; in this way the eae CUT, COAG and detachment plate Lt Quantum Molecular Resonance device with patented technology; high precision and fidelity due to the use of quartz; all the electronic components are in solid state; adjustable power level with regards with digital display or graduated scales; floating patient circuit with high insulation; double safety circuits for the control of inside breakdowns, over-heating and patient plate; self-test at every starting; acoustic and visual signal indicating the power activation; there are two different tonalities in relation to the function selected (cut or coagulation); system composed by 2 microprocessors for displays, keys and safety circuits control; noise suppressors filters in network; case in hard polystyrene, scratchproof and shockproof, with inside screening for electromagnetic compatibility, conforming to the specific norms UL 94 V-0; selectable functions through membrane buttons with LED indicating the function selected; independent connectors from the primary connection for the fulguration, where applicable; protection against the use of defibrillator; cooling for natural convection or forced, depending on the model; filters toward the applied parts to eliminate possible components in low frequency, responsible of neuromuscular stimul: ic pedals available on request; pneumatic, watertight, explosion proof pedals and ele high protection against direct and indirect contacts; complete conformity regarding requirements for the basic safety and essential performance of high frequency surgical equipment (IEC EN 60601-1 ,IEC EN 60601-2-2, etc) standards; during the tests prescribed by the above standards the unit has been subjected to the most unfavorable conditions, either climatic (see temperature and humidity maximum permitted in the manual) or regarding supply (eg supply voltage of 100V for the measurement of power absorption and frequency of 60Hz for the measurement of the leakage currents, etc). respects the EEC/93/42 European Directive and further amendments (EC/2007/47) thus itis classified as a class IIb medical device. SELF-TEST AT EVERY SWITCHING ON there is a test of the electronic circuitry in order to verify the good operation and moreover it articipation of the control systems, During the test period the FAULT LED ie operator has the possibility to verify the test time and the LED good ED can also be controlled activating the device with the plate connected and activating }® with the plate not connected. Pag. 28/35, Vesalius User 3.4.2 ALARMS The dees hassome thermal probes inside for temperature control ee aliteat roading ‘An extended use of the device that do not respect the ON/OFF cycles indicated on the label technical dat gerous elevation of the inner temperature. ‘The control device switches off all the outp display segments lighted on). It is necessary, therefore, to wait for some minutes until the molecular resonane® SUNG Ts again. It's recommended to leave the device turned on in order to speed up the cooling: pe uts and shows on the display the permanent condition of fault (FAULT LED and all the generator has cooled down and then switch iton Neutral plate control: a: Irthe netral plate is not connected, when the monopolar output is activated, the separation plate LED (17) lights on, together with an intermittent sound. The alarm persists until the plate has been inserted. Current control: A work situation in low impedance or in presel power circuit. ‘The intermittent operation of the yellow LED CUT (14) or in an intermittent way the outputs. This signal will turn of current, will stop. In case the anomaly continues, itis necessary to re nce of additional parasitic capacities can lead to an increase of the current in the the blue one COAG (15) signals the current control action and switches off {f automatically when the anomalous conditions that have led to a high duce the power until the LED lights on properly. Mains supply control: To maintain the output power value within the admitted limit range, the nominal value of the voltage is verified. If the voltage increases +10% over the nominal value an acoustic and visual alarm is activated (LED (14) and (15) flash at the same time) and the operation is switched off. It is suggested to use a stabilised voltage. 3.4.3 DEFIBRILLATION PROTECTION ‘The Quantum Molecular Resonance generator has applied parts protected against defibrillator discharge. After exposure to the defibrillation voltage, the device returns in compliance with the essential performance after a time interval of 10 seconds. 3.5 _ CLASSIFICATION ‘The Quantum Molecular Resonance generator VESALIUS® is classified as follows: © class I device with applied part, type "CF"; ‘© device with case not protected against water penetration (IPX0); © device not adapted to the use in presence of an inflammable anaesthetic in contact with air, oxygen or nitrogen protoxide; device for intermittent use (non-CONTINUOUS OPERATION) with cycles ON and OFF. It’s recom id te ct Y specified in the label on the back of the device. ale 3.6 _INTENDED USE The device is designed for typical applications of, but not limited to: OPERATION Mc ™ - ont QUANTUM i peli DeNtal/ A Liplus | RESURF ona ¥ Dermaro.ocy z z Enposcopy v < on Grascowocr |__7 - Livavosconr | ia 7 Manu | 7 ‘Micnosunciene 7 Z 7 ‘Orminumowocr |___ > | 7 7 Z ENT < THRuROALRGERY/ = Zz 7 z SPINE SURGERY. i v Pasournes |___7 7 ELECTROMAGNETIC COMPATIBILITY rhe design of Vesalius® generators led to the development of medical devices able to work properly in a controlled electromagnetic environment and in compliance with the minimum safety distances from mobile terminals (as indicated by EN60601-1-2). ‘The user must then make sure that the electromagnetic environment has the following features: a) Electromagnetic emissions: Emissions test Compliance Hlectromagnetic Environment RF emissions Group 1 ‘This Vesalius® uses RF energy only for its internal function. CISPR 11 ‘Therefore, the RF emission is very low and not likely to cause any interference in nearby electronic equipment. RF emissions Class B This Vesalius® is suitable for use in all establishments, including CISPR 11 domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. Harmonic emissions Class A IEC 61000-3-2 Voltage fluctuations/ficker | Complies emissions IEC 61000-3-3 ‘The presence of other cables or other accesso working in the same environment of the Quantum Molecular Resonance generator may create significant interference during operation. b) Electromagnetic immunity: Immunity TEC 60601-1-2 Compliance Tee Weed apa Electromagnetic Environment Electrostatic 6 kV contact TEC 60601-1-2 Floors should be wood, concrete or discharge (ESD) 8kVair Test level ceramic tile. If floors are covered with TEC 61000-4-2 synthetic material, the relative humidity should be at least 30%. Electrical fast ZV for power supply lines TEC 60601-1-2 | Mains power quality should be that ofa transient/burst 1 KV for input/output lines >3m_ | Test level typical commercial or _ hospital IEC 61000-4-4 environment. Surge 1KV differential mode TEC 60601-1-2 Mains power quality should be that of a IEC 61000-4-5 2kV common mode Test level typical commercial or hospital environment. Voltage dips, short | 0% Us for 0.5 cycles TEC 6060i-1-2 | Mains power quality should be that of a interruptions and | 40% Unfor 5 cycles Testlevel typical commercial or _ hospital voltage variations on | 70% Un for 25 cycles environment. If the user of the power supply input | 0% Unfor 5s Vesalius® requires continued operation lines during power mains interruptions, it is TEC 61000-4-11 recommended that the Vesalius® be powered from an uninterruptible power supply ora battery. Power frequency | 3A/m TEC60601-1-2 | Power frequency magnetic fields (50/60 Hz) magnetic Test level should be at levels characteristic of a field typical location in a typical commercial 1EC.61000-4-8 or hospital environment. Portable and mobile RF communications equipment should be used no closer to any part of the Vesalius®, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Radiated RF 3V/m 3V/m d=12xVP — 80MHzto 800 MHz EN 61000-4-3 80 MHz to 2.5 GHz dm23xJP G00 Met 25GHs conieeaR aT ee Recommended separation distance EN 61000-4-6 150 kHz to 80 MHz d=12xvP Immunity TEC 60601-1-2 Test Test level Where P is the maximum output raj e of the transmitter in watts (yt according to the —_ transmit! manufacturer and dis recommended separation distance i, eters (m). Field pate for fixed RF transmitte, as determined by an electromagnet, site survey, should be less than th, compliance level in each frequency range Interference may occur in the vicinity of equipment marked with thy following symbol: (()) tin which radiated RF disturbances are controlled. The customer rence by maintaining a minimum distance between portable anj nded below, according to the maximum outpi The Vesalius® is intended for use in an electromagnetic environment the user of the Vesalius® can help prevent electromagnetic interfe! mobile RF communications equipment (transmitter) and the Vesalius® as recomme! power of the communications equipment. Rated maximum Separation distance according to frequency of transmitter output power of tal the transmitter 150 KHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5GHz 1 d=1.2xVP d=1.2x\VP d=2.3xvP 0.01 0.12 0.12 0.23 O41 0.38 0.38 0.73 1 12 12 23 10 38 38 73 100 12. 12 23 For transmitters rated at the maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated the equation applicable to the frequency of the transmitter, where Pis the maximum output power rating of the transmitterit watts (W) according to the transmitter manufacturer. Note: (7) at80MHz and 800MHz, the separation distance for the higher frequency range applies (®) These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people ‘3.8 ACCESSORIES FEATURES _ For the complete list of all associated equipments and accessories generators refer to the Catalogues VESALIUS® Accessories and QUANTUM Accessories, accessory; refer to the product code printed on the packaging of indivi Due to the particular technology and frequencies used, the materials constitu or reusable) play an important role in exploiting the performance, also in terms of safety for patients. idual accessories, that can be connected to Quantum Molecular Resonant Each code corresponds to a differe™ ting the separated active electrodes (either dispostt* Telea Electronic Engineering Sri guaranteed the technical characteristics designed for exclusive use with Quantum Molecular Resonan Gnly original accessories are used, which! ice generators, ‘REV. 1.5 4 INSTALLATION, USE AND WARNINGS USAGE CONDITIONS, TRANSPORT AND STORAGE 4.1 ‘The conditions of use and storage of accessories may vary from those shown below for the device. Refer to the instructions contained e accessories package. inth EwviRONEErAL mas “Armospuenic “rowranauns unr Pressum USAGECONDITIONS | +10°C (50°F) ++40°C (104°F) 30% + 75% NC 700hPa + 1060hPa TRANSPORT AND STORAGE | 0°C (32°F) + +50°C (122°F) 20% + 80% NC S500hPa + 1060hPa 4.2 INSTALLATION OF THE DEVICE I's recommended: 1, During installation, in order to avoid crushing or possible falls, to put the instrument on a solid surface in such a way as to not result bulky, on a solid surface and away from the patient. 2, For proper ventilation of the device, it must be sufficiently far from walls that obstruct air circulation and free from any objects placed on the bottom or sideways that can facilitate the heating of the internal circuitry. 3. Keep the device in such a way that is not difficult to disconnect the cable from mains socket in case of need for isolation from the mains. 43 CONNECTION OF ACCE SORIES The pedal cable shall be inserted and screwed into the connectors (25) e (26) which are respectively for the function cut (or cut- coagulation) and coagulation (or fulguration); the two outputs are easily distinguishable by their colours that follow the colours of the functions available on the front panel of the device. The pipe from the double pedal will be connected to the output (25) for the left pedal and (26) for the right pedal, otherwise the absence of airtight, determined by different diameter coupling unit, will occur when pressing the pedals. To ensure the correct watertight connection there is a tapping ring nut. Once the pedal is connected to the device, select the FOOTSWITCH mode pushing the proper key, choose the type of function you want and activate it by pressing one of the two pedals for the cutting operation or clot. ‘The pedal cable shall be inserted into the black connector (27). For devices with both pedals, the singular pedal is reserved to bipolar functions, for the other models used it provides the power for all functions, one at a time, depending on what is selected. Once the pedal is connected to the device, select the FOOTSWITCH mode pushing the proper key, choose the type of function you want and activate it by pressing the pedal for the cutting operation or clot. Footswitch handle: After connecting the pedal insert the handle in the monopolar output (19 o 20) of the front panel. To insert the electrode into the handle, remove the top, insert the electrode and then screw clockwise. After the connection to the device select the FOOTSWITCH function. Press SET (2) on the device, then select the desired type of operation (CUT, CUT-COAG, COAG), press the pedal to activate the electrode (except for LXplus and LXplus+RESURFACING models in which there is no such button, but the functions are available directly), Fingerswitch handle and electrodes: Insert the plug in the FINGERSWITCH output on the front panel. To insert the electrode embed it on the top of the handle until the metal part is completely inside. Once inserted, make sure that the electrode is firmly placed, otherwise repeat the insertion Procedure. After connecting the handle, select the FINGERSWITCH function. Press SET (2), select the operation type (CUT, CUT-COAG, COAG). Then press either button on the handle to activate the feature in the electrode, depending on the operation to do (except for LXplus and LXplus+RESURFACING models in which there is no such button, but the functions are available directly). To insert the electrode, bring it closer to the opening of the handpiece and exercise adequate Pressure until the metal part and the first portion of the covering sheath is not completely inside the handle's bush. The electrode insertion is simplified if this is rotated during insertion inside the handpiece. Once inserted, make sure that the electrode is firmly fixed, otherwise repeat the insertion Procedure. Plug the plate adapter on the NEUTRAL output (21) on the front panel and put down the lever so as to attach the metal plate Permanently. See below for further instructions. Hv Pog. 27/35 i rea in relation to the ty place the plate in @ suitable ih J and P on the front panel hher instructions. Plug the cable on the NEUTRAL output (21) intervention to be carried out. See below for furt 4.4 _ INSTRUCTION FOR USE OF NEUTRAL PLATES zs t highly reduces the risk of Burns. VESALIUS® device uses an insulated neutral plate that ea. Shave, clean and ¢ sible to the surgery a ‘ Ty the rise point as neat 15 Tehesis, ECG electrodes and areas where there i, ids and scars, m 4.41 SINGLE-USE PLATES In case of use of single-use plate choose a very vasculel application area. Avoid hairy, bony prominences, woun concentration of liquids. The current path inside the patient's body must be the shortest po: a run in transverse direction through the body oracrossthe thOT@X | ey the fingers the adhesive borders and massagig Apply the plate starting from the width's side and going on upwards, p! ee eonductive parts and operating bed mus ye ssulate f all the area touching the patient. The patient must further be Kept insulated 00 Ce ewinement 7 t's sl ‘i appropriately grounded. Prevent the cable in direct contact wth So direction of the application. Once you have applieg At the end of the operation, remove gently the plate starting from the plate, do not remove it. Do not use the plate for another operation. le and must proceed diagonally. The current path must neg ssi 4.4.2 REUSABLE PLATES ‘The reusable metallic plate is covered by an epoxy insulator due to the capacitive connection established between the plat ieee When applying the neutral plate on the patient, the use of gel or other conductivs positioning the plate as close as possible to the operating area. Be. Itis pare to avoid letting the current going across the heart zone or the monitoring electrodes trajectory. Particular attention needs to be observed when positioning the plate on children, elderly or skinny subjects. In day hospital operations, where low operating power is required, the neutral plate does not necessarily have to be in direct contat with the skin, but can be placed, for example under a surgical cloth, as far as itis notin direct contact with surfaces that refer tothe ground or with a high connective capacity towards the ground. resin; the energy that is transferred between the plate and the patients the body of the patient. Pen fe substances is not required. It is suficent 45 _MEDICAL-SURGICAL INFORMATION af Use Quantum Molecular Resonance generator with caution in the presence of internal or external pacemakers. Interferenct Produced by the use of electrosurgical devices can cause a pacemaker to enter an asynchronous mode or can block the pacemale effect entirely. Consult the pacemaker manufacturer of hospital cardiology department for further information when use of Quantue Molecular Resonance generator is planned with cardiac pacemakers, Itisrecommended: To avoid the use of the radio-surgery on instable patients, highly dependent on pacemaker. To check the peripheral impulses before, during and after the operation, To choose a place as far as possible from the heart and the pacemaker, Toavoid to use the current to cut (CUT function) outside the hospital structures, To maintain the duration of every emission under 5-10 seconds, VvYvvv ‘To avoid to operate close to the pacemaker or the heart, If during use, the power level is below normal, following points: > conductive surface adheres completely to the ski mn of the pati > check the proper activation of the buttons creer eae ® check the proper connection ofthe active electrade, : > check the Integrity of the insulation of the cables, do not not increase the output control setting of the unit without having checked 4.6 PREPARATION FOR USE 46.1 START-UP PROCEDURE H It Is recommended ¥s"* REV.1.5 4 _ENG _ Vesalius User Ma connect the power cable to the mains socket (28), placed on the rear panel of the VESALIUS® and to the current 0) Goov/115V/230V ~ frequency 50/6042); 2) connect the pedal switches to sockets (25), (26), (27) or (G) (for models LX80, QUANTUM, OR1, LXplus and Lxplus+RESURFACING), placed on the rear panel and indicated with "FOOTSWITCH SOCKET"; 3) connect the monopolar handle to the FOOTSWITCH connector (in case of handle commanded by the pedal) or to the FINGERSWITCH connector (in case of FINGERSWITCH handle). To insert the electrode turn the tip of the handle in a counter- clockwise direction and turn it clockwise to fix the electrode; 4) the handle has to be connected to connector (20) only if the "FULGURATE" function needs to be used (not indicted with the FINGERSWITCH handle); 5) _ifusing monopolar functions connect, if available, the neutral plate to the connector (21), while if using the bipolar functions connect the bipolar handle to connector (22). In case you use LX80 and QUANTUM the connector is the (A). The connectors are separated and have a different polarity in order to avoid errors when connecting bipolar and plate; 6) _toswitch on the device push the power switch (1) to "OI 7) choose the desired function by pushing buttons (2), (3), (4), (5), (6) (yellow and blue push-buttons) and the type of the handle to activate by pushing buttons (7), (8), (9); 8) adjust the desired power through the POWER potentiometer (10) for CUT and CUT/COAG function, (11) for COAG/FULGURATE/BIPOLAR function. Use the (B) knob for the LX80, OR1, QUANTUM, LXplus and LXplus+RESURFACING models; 9) select the timing function (TIMED, (D) button) only if. time activation of the power is necessary; 10) activate the VESALIUS® by pressing the pedal switch or, in case of FINGERSWITCH handle, by pressing the handle push-button; 4.6.2 SHUTDOWN PROCEDURE Shutting down the Quantum Molecular Resonance generator is achieved by moving the switch (1) to OFF, When used, within a short time, for a subsequent intervention it is recommended to leave the device on (in stand-by mode) to allow the complete cooling. After use store carefully all the reusable accessories and dispose correctly the single-use ones. 4. The Quantum Molecular Resonance generator VESALIUS® must be used by qualified medical personnel only. Read the instructions before use. CAUTION AND WARNINGS 4.7.1 GENERAL WARNINGS 1. The output power level selected should be as low as possible for the intended purpose. 2, The patient should not come into contact with metal parts which are earthed or which have an appreciable capacitance to earth (for example operating tables, metallic supports, etc). 3. WARNING: to avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth. 4. If the VESALIUS® is not used for an extended period of time, or if the procedure for setting the correct choice power intensity is not known, it is better to select, initially, a low power and gradually increase it till you reach the correct intensity that allows you to get the desired effect. 5. A failure of Quantum Molecular Resonance generator VESALIUS® result inan unintended increase of output power: 7.2 RISK OF EXPLOSION AND BURNS a tlt ita 6. The use of flammable anaesthetics or oxidizing gases such as nitrous oxide (N20) and oxygen should be avolded procedure is carried out in the region of the thorax or in the head, unless these agents are sucked away. Non-famim: REV. 1.5, 9°. 473 10. 11, 12, 13, 14, 15, 16. 17, 474 18, 19, 20. ai 22, 23. 24, 475 as REV.1.5 .d to clean, or to dis; Je substances use he He ‘of high frequency surgery. ody areas. Any fluid pooled in these area, genous gas is evident. Some material, lik, ics produced in normal use of the Quantun, ble. Flam agents should be used for cleaning and disinfection wherever POR ica oras solvents of adhesives, should be allowed to evaporate Batre TO uman ‘There is risk of pooling of flammable solutions under the pa eg of endo should be mopped up before using the device. The danger A iy spar absorbent cotton and gauze, when saturated with oxygen, may Molecular Resonance generator VESALIUS®. us gases Attention should be called to the danger of ignition of endogenous B s ous inflammable or explosive substances yr gast The instrumentation must not be used in presence of liquid, solid oF & ACTIVE ACCESSORIES If the metal is exposed there is the risk of curren, ire. Replace the electrodes if the insulating protective wrap is not entir dispersion that can hurt the patient. Replace the handles when the cables show signs of deterioration. erator is switched off. Before proceeding to the substitution of electrodes and handles, check the gen it i ices must be positioned in a way ‘The connection cables with the VESALIUS® electrodes/accessories or nn one een Pie ane a ea? not to touch the patient or other cables. The patient should be positioned in other leads is avoided. store them tem Do not keep simultaneously two handles connected to the equipment even if they are inactive bu porary in another place far from the patient. ‘Temporarily unused active electrodes should be stored in a location thatis isolated and far from the patient. Itis recommended to use bipolar techniques in case of surgical operations on body parts having a relatively small section and to coagulate vessels of a particular diameter, in order to avoid damages on surrounding tissue. The functional characteristics are guaranteed only if original accessories are used. RISK OF INTERFERENCE The VESALIUS® and the monitoring devices must not be connected to the same fixed current socket of power supply (independent cables for the connection to the net of power supply must be used). Skin-to-skin contact (for example between the arms and body of the patient) should be avoided, for example by insertion of dry gauze. Inall cases, monitoring systems incorporating high frequency current limiting devices are recommended, Do not activate under any circumstances a second plate or neutral electrode (including Megadyne plates models), even if it is connected to other generators (especially if type BF applied part) that are switched off. When the VESALIUS® Quantum Molecular Resonance generator and tori i Physiological monitoring equipment are used simultaneously on the same patient, any monitoring electrodes that do not contain protection cee high frequency inductors should be placed as far as possible from the VESALIUS® electrodes. It it ale recommended that the + and ~ ‘monitoring electrodes must the nearest possible, Needles monitoring electrades are noe recommended. INSULATION NEUTRAL ELECTRODES Ifthe neutral plate is used: a. See section 4.4; b. the neutral plate should be reliably attached t close as posible tothe point of operation, SPY Prepared and appropriate area of the patient's body and ©. check that the neutral plate is correctly positione areas, bony protuberances, metalic prosthecls oe ea oanecting tons reserved for children and skinny peoples Se ‘ears, adipose zones, cutaneous folds, hal”) § or electrodes. Particular attention must disinfectants, rinsing i is iquids, Physiological sol s ti between the neutral plate and the body of the patie positioned; a e. inorder to avoid interferences, k Ke neutral plate and from the peso Accessories used to detect cardiac parameters as far as posible from the f Apparent low output or fail ESA Specs para ure ot the VESALIUS® Quantum Molecular Resonance generator to function correctly at the MVGiIseze cheapaticatn ae icate a faulty application of the neutral electrode or poor contact in its connections. neutral electrode should be checked before selecting a higher output power. s or other current dispersive elements must not penetrate Moreover it is recommended to check the plate is correctly 6, Although VESALIUS® 2 ae ESSLUSse Quantum Molecular Resonance generators have measures to reduce neuromuscular stimulation, this pletely eliminated when electrical arcs are produced between active electrode and tissue. The user is aware that in sensitive structur weer by muscle congo eative Structures neuromuscular stimulation may still occur and resulting in a secondary hazard he VESALIUS® 27. prenvesal - pee tani eee Resonance generators use a continuity monitor and not a contact quality monitor. The clart ob olene dete sate contact between the neutral electrode and the patient will not result in an auditory alarm. plate detachment will be activated in case of lack of continuity in the neutral electrode circuit. A Do not use VESALIUS® generator and other generators at the same time on the same patient. 4.8 SECURITY ACTIONS Outputs activation Inorder to avoid an involuntary activation, a function or an output selection is not possible while a pedal or a finger inputis working If poe push-buttons are pressed at the same time the output function comes from the first pedal activated and persists until the release of it. Push-buttons control Inorder to enable or disable any output function it is absolutely required to select first key n.2 (SET) and then the interested selection, eventual wrong settings are, therefore, avoided (except for LXplus and LXplus+RESURFACING models in which there is no such button, but the functions are available directly). 5 CLEANING, DISINFECTION AND STERILIZATION aa DEVICE CLEAN-UP _ Pull out the plug before cleaning it! Do not use inflammable, explosive substances, plastic dissolvent or abrasives. Itis possible to do a disinfection with a humid cloth (for example with benzalkonium chloride) and then with a dried one, Incase of room sterilization, cover the device with a plastic cloth. Do not directly pour liquids on the device, do not use the autoclave or sterilize it with gas. lowing steps ensure proper operation and increase the longevity of the nd never attempt to make repairs yourself. Carefully examine each surgical m2 ACCE! RIES CLEAN-UP AND STERIL IZATION, A proper maintenance and the compliance with the fol surgical instruments. Do not use damaged instruments a instrument for breaks, cracks or malfunctions before use. 5.2.1 CLEANING q 1d tissue that remains on itby 1 the operating table, can be cleaned up from liquids of the body or dries ee eal eheanverare te sterilization it is suggested cleaning the electrodes up and checking if there is any Fite riviera Til inactive electrodes perfectly clean, asthe best performance is achieved only when they are properly cleaned and stored. Peso a rca nas allow the same motialites used for te electrodes, being careful to dry them accurately after the manual pe, (avoiding the presence of liquids in the connectors). eae oie toy are wl exe the useful life of the accessory. Special attention must be paid to 1 t drneea aman one nes oe on oe ‘can aj a cycle. Do not use damaged instruments. _ ENG De eet ’s recommended not to use : lised with standard modalities. It's Biss The reusable neutral plate can, after the manual cleaning, be steri and corrosive substances. acids si in All the pedals can be cleaned and disinfected with gauze wet with ne i electrical problems in case of liquid infiltration, since all pedals are prote recommended not to use acids and corrosive substances. « (for example benzalkonium chloride). There are n Fans che effects of ingress of liquids. In any case 5.2.2 STERILIZATION Instructions for use included in the package of accessories contai packaging, sterilization and storage of accessories. It is recommen following is a non-exhaustive summary of the main tasks. After decontamination the accessories should undergo to a washing procedure to red’ Wee Tt attention mus contamination and deposits which are difficult to be removed and affect the sterilization PUNT Td connectors for cuts voide be paid to slots, stops, ends, hollow tubes and other highly inaccessible areas. Check insulitis At aa cracks, tears, abrasions, etc. If necessary, repeat the reprocessing process until the instr Bat taieichinly packaged pens instruments of all debris, tissue and foreign matter prior to sterilisation. All accessories mus ly with a double envelope) suitable for steam sterilization. Caution: for the sterilization of reusable accessory use steam autoclave sterilisation only in consideration of the respective national requirements and according with ISO 17665 / EN 285. VESALIUS®'s accessories are checked and validated for the steam steril may be possible but in this case the concerning sterilization cycle must be validated. obtain information about it. mation regarding the decontamination, cleaning d infor zm in detailed ‘nity what is indicated in such instructions since the ded to refer t 0 reduce qualitatively and quantitatively microbja} ization and the ETO sterilization. Other sterilization methods Contact the sterilization device manager to Attention: Telea Electronic Engineering Srl does not guarantee the compatibility of its accessories with sterilization methods different from by steam and ethylene oxide. STEAM STERILIZATION: The steam sterilization in water happens by thermal effect, the steam is the way to transfer heat from the heating element to the object to sterilize. To obtain a successful sterilization, this combination is recommended: To sterilize in the best way, these values are considered proper | TEMPERATURE TIME PRESSURE 134°C 5 minutes 2.05 bar | ‘The warming time, the depressurization phase, the cooling and the drying time, must be added to these values. Bl N.B.; in any case never exceed the 137°C and 2.2 bar of pressure. In some cases the parameters above may vary. Carefully read the directions and specific sterilization parameters indicated in all accessories datasheets. Follow the instructions provided by the manufacturer of the sterilization system for further details on settings and loading procedure, In order to achieve a successful sterilization, there must be a direct exposure of steam on all surfaces, including the internal ones. Dry and ventilate carefully before use. Attentions and shrewdness: The following treatments lead to a faster usury of the accessories and are therefore to be avoided: = cleaning up with objects that have rough edges (chisel, scraper), damages the insulation and the contact surfaces; = steam sterilization over 137°C. < Storage Sterilized instruments have to be stored ina dry, The instruments should be stored individually i stored in drawers. clean and dust free area at a moderate tem| 1 perature from 5°C to 40°C. n their shipping package. Carefully protect tips with proper materials, especially if ‘Telea Electronic Engineering Srl guarantees the products withstand toa minimum ce REV.1.5 tall How: ae rere in number of sterilization cycles ace ae ] Ref. 2502XXX_ eee Handles | (except for 2502008 and eae Hea which are not up to 30 cycles Forceps and scissors | Ref, 2606XXX and 2613Xxx 20 cycles Electrodes with wire's diameter <0,25mm | - = al - up to 5 cy up to 10 cycles? eee ae | > le cles oe rissb Je electrades*? Replace thematthefirst slgnsot worsening 9 ee | YP ee ype The number of cycles is indicative, it may var ciications contained in the sterilization section o1