USERS MANUAL
Contents
1. 1 2 3 14 15 14 4 20 S ring Medizintechnik m gem mm Nm ee 21 not valid for MBC600 27 04 04 Soring Users manual RF units 5 General description of the equipment The MBC RF surgery equipment makes different applications available For monopolar applications in addition to the basic continuous power output three coagulation methods are available i e Spray Force and Soft may be selectable For cut functions it has to be distinguished between pure cutting and cutting with the functions Blend TUR Pulse and Pulse TUR Additionally the devices offer the bipolar applications Cutting and Coagulation For monopolar applications five output steps are quickly pre selectable These can be further divided for finer dosage by arrow keys The selected power corresponds to the maximum power output in watts is indicated on the three digit display Furthermore it is possible to use the bipolar channel and the monopolar coagulation in combination with the Autostop function see above Different effects for a given signal shape and voltage have been described in more detail in chapter 3 2 The expected output characteristics for the different applications are shown in Technical Data chapter 8 The unit can be programmed by users for up to 10 different programs The stored values will stay in the memory even after the un2. Use the arrow keys 14 to adjust the power When pressing the arrow UP button the display counts up when pressing the arrow DOWN button the display counts down The displayed value is the maximum power output in watts Power step display Indication of selected power step see Technical Data chapter 8 Power display This shows the maximum power output in the chosen step in watts Additionally the small green light in the relevant text field i e MONO CUT shows which function has just been activated Up and down keys for fine adjustment By pressing these buttons the power output can be varied above or below the default power steps Autostop key Mono By activation of this button coagulation is automatically controlled stopping the coagulation current after around 1 second even if the foot or fingerswitch is still pressed Often this time is sufficient to coagulate certain tissues Volume control The loudness of the acoustical operation signal is adjustable by this control The lowest selectable sound level is given by VDEO750 part 2 2 respectively EN60601 2 2 to 40 dB A at 1 meter distance and can thus not be influenced Take note that the loudness of the warning signal is not limited by the volume control Power connection The power cable supplied by the manufacturer of the equipment for connection to an earthed outlet must be used for more details see also power supply data Integrated into the power supply socket is the fu
3. 3 1 1 Reaction of biological tissue to local overheating If RF voltage continuous sine signal reaches a certain upper limit an arc will occur at the contact zone of the active electrode to the tissue This leads to a quick heating of the intercellular fluid This vaporization of the intercellular fluid results in a bursting of the cells and the tissue looses its cohesion i e the electrode cuts Lower RF voltages below 150v lead to a slower heating of the tissue resulting in coagulation with no tissue separation Short RF impulses with high voltage lead to a build up of sparks together with a strong surface coagulation not valid for MBC600 27 04 04 Soring Users manual RF units active electrode horny layer papilliary body 07 subcutaneous fatty tissue musculature with connective tissue vessel bone Fig 3 2 Schematic representation of a melt cut Depending on the value of resistance of the different effected tissue the coagulation seam the heat damage is more or less widespread broader at the horny layer than in the papillary body or the subcutis even wider in the fatty tissue In the musculature the heating effect melts deeper into the gaps of the connective tissue Within a cut vessel the blood retracts and the intima is damaged from the different wall layers over a large area In bones the heating effect spreads along both sides of the p
4. Thereby the skin dries out the transfer resistance is further increased and burns may result Fig 4 5 Position of EKG electrodes for use in connection with RF surgery These recommendations are valid for normal EKG cables Special EKG cables for RF use are excepted In case RF surgery is applied at the thorax or at body parts above the thorax the use of unipolar electrodes for extremities according to Goldberge are recommended In order to reduce possible fault currents special EKG cables for RF use with current limiting resistors of 10 kQ and a built in RF choke should be used see Fig 4 6 not valid for MBC600 s 7 27 04 04 Soring current limiting Resistors ma Aktivelektrode 9 Active electrode N EKG N ECG Aktivelektrode Active electrode Neutralelektrode Patient electrode Fig 4 6 EKG cables with current limiting resistors 4 4 Current carrying cables RF surgery equipment monitoring electrodes etc In RF surgery attention should be paid that electrode cables active electrode patient electrode are as short as possible are laid out without loops see Fig 4 7 are laid out so that they do not touch the patient or other cables risk of capacitive current coupling Strombegrenzungswiderstande Users manual RF units Needle electrodes are not recommended for EKG monitoring Because of their small surface area the risk of burns is increased Monito
5. Acoustical signal for cutting and coagulation must be present Handpiece mode recognition must light up Connect bipolar connecting cable and bipolar tool according to instruction manual Switch on equipment Select a power step for bipolar cutting and coagulation and activate the footswitch Acoustical signal for bipolar function must be present Bipolar mode recognition must light up Check of handpieces and footswitches Perfect condition of plug and cable Mechanical faults especially cracks in handpiece housing Function test of all handpieces and footswitches not valid for MBC600 35 27 04 04 Soring Users manual RF units 9 3 3 Check of RF generators and safety devices Function test of RF generators RF relays and leakage current detector The following equipment is needed Measuring device for RF surgery equipment for measurement of output power and RF leakage current e g BIO TEK RF 302 Handpieces Connecting cable patient electrode original Soring cables connecting clamps Preparation Connect RF measuring device to Arco respectively MBC in accordance with instruction manual According to type approval the unit based on class CF PE not capacitively grounded Current leakage measurements have to be carried out according to this class Based on the type approval the unit is in the CF class The measuring of the current leakage has to be done with regard to this type of approval class 9 3 4
6. Mode 14 together with TissueLink Bipolar fluid supported instruments The irrigation fluid could disturb the recognition of the automatic function TissueLink fluid supported instruments have to be used only without activated bipolar automatic not valid for MBC600 14 27 04 04 Soring Users manual RF units 4 Patient safety The power output should be reduced to a value as small as possible in order to obtain maximum patient safety with the application Apparent low output of the RF surgical equipment to function correctly at the normal operating settings may indicate faulty application of the patient electrode and its contact in its connections 4 1 Patient placement With applications of RF surgery equipment any contact of the patient with grounded metal parts has to be carefully avoided In order to ensure this the following points must be observed The patient shall not touch any piece of metal i e OR table or any other metal parts If necessary insulating arm or leg cuffs must be put on Conductive respirator hoses must not lay in contact with the patient The patient must not be laid down on moist sheets Excretions ofthe body such as perspiration secretions blood and so on liquids put on for cleaning purposes or applied liquids like infusions and so on must not soak through the dry sheets If necessary it must be possible to suck it off immediately and thoroughly in order to avoid the gathering of liqui
7. Power measurement Use RF measuring device in position power measurement and with the listed table resistor Tolerance should be within 20 of the value in the table Values for power output see table in chapter 8 In general the function is correct if the measured RF power does not deviate more than 20 from the nominal value 9 3 5 Current Leakage test Measurement is performed with a load resistance of 2002 a monopolar RF handpiece and the genuine S ring connecting cable During this measurement the cable must not be rolled up Measuring equipment is to be operated for PE current and active electrode current measurement perform both modes Check all modes and power steps Current leakage must be less than 150mA 9 3 6 Test of handpiece allocation relay If the equipment provides several handpiece sockets and both monopolar handpieces are connected it has to be checked if every channel refers to the correct outlet When one handpiece is activated it has to be tested whether the not activated handpiece delivers power In that case one of the handpiece allocation relays is defective 9 3 7 Test of patient electrode recognition Connect handpiece and patient electrode to equipment If a divided patient electrode is used Connect patient electrode according to instructions and switch on equipment gt Patient electrode alarm and operational inhibition must then be activated gt Patient electrode alarm must disappear and
8. Switch the unit on connect the handpieces and set the parameters as usual After all parameters are set as wanted change to the program function by pressing the PROG button Now the values disappear in the displays and the CUT display shows Pro Storage of these values can now be done bypressing one of ten program buttons The buttons to be used are the 5 step buttons in the Mono CUT and Mono COAG field indicated by the letters 1 10 The available programs will be displayed by illuminated LED s To store all values the wanted program button must be pressed continuously for around 2 5 seconds until Sto will come up in the CUT display Now all pre adjusted parameters are stored permanently and the unit returns automatically after a short time back into the standard mode The storage process deletes all prestored parameters belonging to this program button This storage process will not affect the remaining 9 buttons To store further programs please repeat the above steps and store new values in the free storage II Working in the program mode with prestored values Switch on the unit and connect all needed handpieces To choose a program press the PROG button to go from the standard mode into the program mode Now activate the wanted program by pressing one of the 10 program buttons already used storage s will be displayed by yellow LED If the handpieces are connected the stored power parameters will appear in the dis
9. contact Resting on bone projections must be avoided Furthermore any metal parts inside the body i e bone nail endo prosthesis bone plates screws etc must be considered as they may influence the current supply All external metal parts like rings necklaces bracelets body piercing jewelry etc must be removed The patient electrode must be attached so that the current paths between active and patient electrode are as short as possible and directed alongside or diagonal to the not valid for MBC600 15 27 04 04 Soring Users manual RF units body but under no circumstances at the thorax because in this case the heart would be located in the direct current path Fig 4 1 Suggested placement of conventional patient electrodes and relevant operation fields Permanent electrodes must be carefully secured with a flexible bandage or with elastic bands Wet towels paste for electrodes and so on are not to be put underneath On the other hand paste may be used with adhesive disposable electrodes if drying out of the paste is avoided To insulate the patient electrode also against its surroundings it is to be wrapped with a bandage after setting Fig 4 2 Correct fastening When using self adhesive disposable patient electrodes building up of blisters beneath the electrode may occur due to incorrect handling wrong electrode paste etc Thereby the contact surface is reduced and burns are possible The c
10. controls and indicators seen nns sn nnn nnne nnne nnne 22 5 1 1 Description of the Safety Equipment sse enne nennen nennen SARA KR RAKA RO KR innen 27 5 2 Putting the equipment into operation 28 5 2 1 Description of operational facilities esses eene nennen nnne snnt 28 5 2 2 Preparation of egu p MEE a a a a a E aE a E a EEOAE AA A EET 28 5 2 3 Switching on the eg9UjD1me ie 28 5 2 4 Adjustment of function fields sese entente nennen ness e enne 29 6 Accessories BXITROCIS ineinander een 30 7 Cleaning maintenance disinfection and sterilization 31 8 Technical 32 9 Technical safety Checks nun een 35 not valid for MBC600 3 27 04 04 Soring Users manual RF units 9 1 Intervals nescis Imi MI eei A E AE A 35 35 9 3 Description of special checks s ssssssssssssssssssssssssnnssnsnnssnnnnnssnnnnssn nns sn innu nnns inse RR RR inse RR RR RR nnns 35 9 3 1 Check of controls and indicators 35 9 3 2 Check of handpieces and footswitches 35 9 3 3 Check of RF generators and safety 98eViCeS 36 9 3542 Power measurement disi aor ats ashes hea ha dea eto petiit aden ee
11. product log book to the same extent and is available for the user at any time The following entries are to be made in the medical product log book 1 Date and time of the function test before operating the equipment for the first time 2 Date and time of instruction as well as the names of the instructed persons 3 Date and time of performing required safety checks and maintenance as well as the name of the person or the company performing these checks 4 Date time kind and consequences of failures and of re occurring similar operation mistakes A copy of the CE certificate must be kept with the medical product log book not valid for MBC600 6 27 04 04 Soring Users manual RF units 2 5 How to keep the instruction manual and the medical product log book Instruction manuals and equipment books for RF surgery equipment must be kept so that they are always accessible to persons commissioned to use the equipment The responsible authority may ask to look at these books at any time 2 6 Accident and damage report Function failures or breakdowns of medical equipment causing bodily injury must be reported immediately to the authority responsible The hospital must report the incident to the FDA and include all of the pertinent information as required by that agency Suggested information to be gathered by the hospital includes the following 1 What caused this event 2 Was the equipment in proper operating conditio
12. reappear If a non divided patient electrode is used Alarm must sound when patient electrode is removed from connector socket not valid for MBC600 36 27 04 04 Soring Users manual RF units Remarks not valid for MBC600 237 03 092ns
13. 1 MHz etal blood silver 0 0000016 muscle kidney heart copper 0 0000017 liver spleen gold 0 0000022 lung aluminum 0 0000029 fat Table 3 1 Comparison of specific resistance of metals and biological tissue The desired thermal effect should be accomplished within a small area in front of the active electrode Conditions for RF heating are areas with small cross sectional area and low electrical conductivity The actual temperature at the contact area between the active electrode and tissue results from the energy balance The energy supplied is influenced by Current per area dependent on specific resistance of the tissue and the shape of the electrode Effective time the time that the RF current acts on the tissue area as determined by the electrode type and velocity of the electrode over the tissue Current shape full power alternation of power or changing power levels The conducted heat is influenced by The condition of the tissue particularly at any given moment of the application cycle because the local thermal conductivity changes as tissues are destroyed Temperature because additional energy is needed for vaporization of tissue fluid not valid for MBC600 8 27 04 04 HF Generator RF generator S ring Users manual RF units Aktive Elektrode active electrode biologisches Gewebe biological tissue Neutral Elektrode Fig 3 1 Shows the principle of RF Surgery N
14. Accessories extracts Reusable patient electrode The reusable patient electrode consists of soft flexible and conductive silicon material The patient electrode can be connected via an additional cable to the RF surgery equipment The reusable patient electrode is available an undivided version Disposable patient electrode If disposable patient electrodes are used they should have divided electrode surfaces because only in this case the equipment checks for correct application of the electrode For adapting the disposable electrode a reusable patient electrode cable is available Handpieces For monopolar application handpieces with finger switches for footswitch operation are usable For the handpiece adapter a variety of accessories is available see order list Bipolar connecting cable For the adaptation of bipolar tools connecting cables from manufacturers are available Further bipolar connecting cables are available on request Only those approved by Soring must be used Footswitches protected against explosion The double pedal footswitch is used to activate the monopolar channels cutting and coagulation and to activate the bipolar function The footswitches are watertight and may be used in rooms where explosion hazard is present not valid for MBC600 30 27 04 04 Soring Users manual RF units 7 Cleaning maintenance disinfection and sterilization Equipment The equipment should only be treated with n
15. LED switched off By pressing the PROG button the user can return into the normal mode ATTENTION Adjustments that relay to the switch off of single function units i e footswitch allocation or conscious switch off by pressing an active step button twice will be taken from the standard mode into the program mode If i e a monopolar footswitch handpiece and a bipolar instrument are connected one of them is automatically blocked The blocked function will be shown by a black display of the relevant key field By pressing one button in this dark field it will be activated the footswitch will be assigned to it and the former active field will be shut dark If the user now switches from standard mode into program mode by pressing PROG and chooses a program this activation de activation of the function field will remain unchanged This is independent from the conditions during storage and is also relevant if function fields were turned off by a button 5 1 1 Description of the Safety Equipment This RF surgery equipment is provided with different safety devices in order to protect the user and the patient from possible harm In the following safety and warning devices are described which are indicated on the safety field 10 of this equipment 1 Patient electrode PE If a patient electrode with double contact area is used the electrical connection between eguipment and patient electrode is automatically monitored as well as the applicatio
16. These fluids should be absorbed and removed In order to avoid endogen gases the patient should be fed with an appropriate diet prior to the operation Furthermore the gastro intestinal tract must be opened without RF surgery Explosive anesthetic agents especially open anesthesia procedures must not be used in electro surgical operation on the head respiratory ducts lungs and stomach The units are not certified under AP classification If combustible anesthetics laughing gas or oxygen are used in the thorax or head these substances should be directly sucked away or a unit of the AP class should be used instead 4 6 Instructions for special applications If the operation with RF surgery equipment is extended over different parts of the body the position of the patient electrode must be optimal for all areas of operation For RF surgery equipment with two monopolar connections problems will arise when two electro surgical operations are performed simultaneousiy on the patient The surgeon should therefore decide whether it is really necessary to perform these operations simultaneously or whether they can be made one after the other The simultaneous use of two HF surgery units on a patient is not allowed When operations on small parts of the body are performed e g vessels or hollow organs the use of bipolar technique could be advisable in order to avoid unwanted coagulation at other parts The simultaneous app
17. USERS MANUAL MB C601 S ring S ring Made in Germany 27 04 04 Soring Users manual RF units Soring Inc Soring GmbH 5009 Martin Luther King Jr Freeway Medizintechnik Fort Worth Justus von Liebig Ring 10 TX 76119 25451 Quickborn Tel 001 817 457 2200 Tel 49 0 4106 6100 0 Fax 001 817 547 2201 Fax 49 0 4106 6100 10 E mail soring usa soering com E mail info soering com BH MBC USA 04 2004 03 092 R3 not valid for MBC600 Epe 27 04 04 Soring Users manual RF units Contents TINH OGUCTION M MR RR 5 2 Important notes regarding the operation of RF Surgery units 6 2 1 Operating of RF Surgery 6 2 2 User instructions HE 6 2 3 Prescribed safety checks ss ssssssssssssssssnssnssnsnnssnnnnssnnnnssn nns sn nns An nn nnmnnn nnmnnn nannan nnmnnn nnmnnn nnn aenean 6 2 4 Medical Product Log BOOK ss sssssssssssssssssssssssssnssnsnnssnsnnssnnnnssn 6 2 5 How to keep the instruction manual and the medical product log book 7 2 6 Accident and damage 7 2 7 Modifications and repairs eese 7 3 Physiological and physi
18. ately to a pre selected step and then use the arrow keys 14 to adjust to intermediate levels of power When pressing the arrow UP button the display counts up when pressing the arrow DOWN button the display counts down The displayed value is the maximum power output in watts ATTENTION Do not use Bipolar Automatic Mode 14 together with TissueLink Bipolar fluid supported instruments The irrigation fluid could disturb the recognition of the automatic function TissueLink fluid supported instruments have to be used only without activated bipolar automatic not valid for MBC600 23 27 04 04 10 11 AN o S ring Users manual RF units Safety field For detailed description see chapter 5 1 1 Patient Electrode failure Indication for correct patient electrode connection Functional error Shows malfunction of equipment during internal safe test Error code is shown on 7 segment display CUT Dosage error Indication that an equipment dependent output power error occurs Function field for monopolar Cutting modes When none of the following buttons are activated the unit works in pure cutting mode TUR When pressing the TUR button the power for cutting will be increased This is needed for so called under water cuts as are used in Transurethral resection Blend When pressing the Blend button the pure cutting function is changed to a blend mode combining a combination of cutting and coagulation functions Part of t
19. ave been introduced to the correct use of the equipment according to the instruction manual Only people with sufficient knowledge of how to handle the equipment and practical experience are allowed to instruct others If such instruments are combined with additional equipment the instruction of the operating personnel must be extended to the combination and its special functions 2 3 Prescribed safety checks The user of the RF Surgery unit must carry out the prescribed safety checks within the period stipulated and to the extent required The extent and the periods for safety checks for RF equipment must be performed according to manufacturer s recommendations regarding extent and periods of inspections during servicing Safety checks of the technical protocols must be assigned only to those who have the appropriate education the knowledge and the experience gained during their practical work enabling them to carry out those checks accordingly The safety check should be performed in a distraction free environment If failures are found during safety checks which may endanger patients staff or third parties the technician must immediately inform the authority responsible for the use of the instrumentation 2 4 Medical Product Log Book The supervising operator of RF Surgery units must keep a medical product log book Other documentation is equivalent to the medical product log book as long as it fulfills the requirements of the medical
20. ble Cable has to fulfill accepted norms and has to have a diameter of 1mm Potential Connector according to DIN equalization 1000 VA Power consumption Classification Safety class 1 Safety grade according to EN60601 1 CF Classification Il b Weight 601 er 42 Ibs 19kg 600 er 41 Ibs 18 5 kg Dimensions WxHxD 430mmx150mmx430mm Applied standards 93 42 EWG EN60601 1 EN60601 2 2 not valid for MBC600 34 27 04 04 Soring Users manual RF units 9 Technical safety checks 9 1 Intervals Safety checks must be carried out annually 9 2 Extent Check for presence of medical product log book and instruction manual Check for electrical safety Check of protective conductor lt 0 3Q Check of equipment current leakage lt 0 5mA Patient current leakage monopolar application part CF lt 10uA without activation Patient current leakage bipolar application part lt 10uA without activation Check of controls and indicators Check of RF generators Check of safety devices Check of patient electrode recognition Check of handpieces and footswitches for proper condition 9 3 Description of special checks 9 3 1 9 3 2 Check of controls and indicators Connect handpieces and patient electrode according to instruction manual Switch on equipment and check indicator lights Select a power step for cutting and coagulation and activate handpiece blue or yellow button respectively footswitch
21. cal fundamentals of RF Surgery 8 3 1 Heating effect of RF currents in biological tissue eere 8 3 1 1 Reaction of biological tissue to local overheating somoasessessarsrarsrarerrrsrrrerrrerrre rare r ann r Ann RR RR eene enne 9 3 2 Methods of RF Surgery and electrical Signal Shapes eese 12 CRAS CUT G E 12 3 2 2 a Ar adh ea Sa eas 13 CS 13 3 2 5 Bipolar application technique sse eene nnne 14 3 2 5 1 Bipolar Automati on qe eee dr a ere e dera es 14 4 CHIETI Ctm 15 4 1 Patient placement iiie ecc a 15 4 2 Attachment of patient electrode 15 4 4 Current carrying cables 22ER ces Ddeck suras aha 18 4 5 Dangers from inflammable and explosive media eene 19 4 6 Instructions for special applications neenreennnennnnnnennnnnnnennnnannnnnnnannnnnnnennnnnnnennennnnannennnnnennen nennen 19 Arrangement of Switches Sockets and displays Of MBC 601 20 Arrangement of Switches Sockets and displays of MBC 600 21 5 1 Description of
22. coagulation mode for the function field coagulation There is a choice for Soft Force and Spray Coagulation selecting the desired degree of coagulation with respect to output power output voltage and signal shape see Technical Data chapter 8 Additionally to the normal Force coagulation a certain cutting degree can be mixed to the coagulation power to allow a less bleeding cut Comparable to Blend cutting When you keep pressing the button for around 1 5 sec Fr and a value from 1 9 will light up in the coagulation display This cutting degree can thus be varied by the arrow keys in 9 steps from 1 no up to 9 strong Additionally to achieve a better TUR coagulation the unit can be adjusted to HI with the arrow keys turn completely down Function keys for bipolar modes Auto Stop Button Pressing this button enables AutoStop mode In this mode the HF generator will be activated for around 1 5 sec by either the footswitch ATTENTION Do not use Bipolar Automatic Mode 14 together with TissueLink Bipolar fluid supported instruments The irrigation fluid could disturb the recognition of the automatic function TissueLink fluid supported instruments have to be used only without activated bipolar automatic not valid for MBC600 24 27 04 04 12 13 14 15 16 17 18 Soring Users manual RF units Bipolar automatic button Pressing this button enables automatic mode In automatic mode a tissue contact by the f
23. ctrode influences the cutting action and the kind of cut in electrotomy Basically cutting electrodes should have a tissue contact area as small as possible in order to obtain a high current density within a narrow space Loop or Ribbon Electrode i P MS Knife or Lancet Electrode Needle or wire electrodes are particularly useful for fine cuts where no or only minor coagulation is wanted They present a very small tissue contact area allowing a high current density needed for fine cuts With higher power the electrode will overheat and tissue will stick to it Needle or Wire Electrode Fig 3 5 Shapes of electrodes Knife or lancet electrodes resemble conventional scalpels with respect to their geometrical shape The cutting action however is based on the above mentioned principles and not on mechanical action The leading edge of a knife has a small contact area where high current density can be produced for a fine cut whereas the broad sides of these electrodes achieve coagulation along the cut surfaces Due to the relatively larger surface compared with the needle electrode more RF power is required However the heating of these electrodes is lower due to their higher thermal capacity Loop and ribbon electrodes are mainly used for the cutting tissue by in slicing A major application of this so called hollow cut is the TUR Transurethral Resection in urology Further parameters which influence the quality of the cut are
24. d beneath the patient Urine secretions must be drained via catheter Areas with strong secretion of perspiration extremities Iying close to the body or areas where skin touches skin must be kept dry by sheet covers Anesthesia must be adjusted so that strong secretion of perspiration will be avoided Liquids of any kind must not be sprayed spilled or used in ample quantities in order to avoid its collection underneath the patient 4 2 Attachment of patient electrode This RF surgery equipment is provided with a patient electrode monitoring which checks the correct attachment of the patient electrode by measuring the transfer resistance between the patient electrode and the patient tissue For this measurement the use ofa split patient electrode is necessary Although the use ofan undivided patient electrode is possible the manufacturer does not recommend it In order to apply the patient electrode carefully and safely to the patient the following shall be observed If an undivided patient electrode is used the monitoring circuit only checks the connection between patient electrode and equipment However no monitoring takes place if the patient electrode is connected to the equipment but not attached to the patient It is the responsibility of the OR staff to check the reliable attachment of the electrode to the patient The patient electrode must be applied to the patient with its full surface in order to achieve an even
25. e 5 i a fax fw y a not valid for MBC600 130W 6 210W 130W 320W 210W 320W 6 7 1W 10W Ow 1W W 16W W W 1W W Ow W W OW OW OW 4W 22W 4 2 40W 40W 80 120W 230 1160 1240 1290 1320 1160 1240 1280 820 8 1320 94 1250 1320 1320 1320 1180 1250 1300 1320 1320 1180 1250 1300 1320 1320 30 0 320 480 0 80 80 62 6 6 27 04 04 Soring Users manual RF units BLUE ZUM erogueney pizi _ Q W Frequency kHz Vpp Force 3 Force 4 Force 5 sow PNE OO O Spray2 sowpoog 20W _ 90004800 Sprays eswpooog law 90W 9000 4700 Spray 4 Spray 5 120W 200 2 90W 120W d 9000 5800 1 130W 2000 360 330 760 60 160 460 Ignition Working voltage Bipo Coag 1 140W 1000 Output voltages are no load values pulse shaped signal Signal shapes Cut 1 5 step continuous sine wave Blend 1 5 step pulsed sine wave duty cycle 80 TUR 1 5 step continuous sine wave Pulse 1 5 step continuous sine wave pulsed Soft 1 5 step continuous sine wave Force 1 5 step pulsed sine wave duty circle 25 Spray 1 5 step spike shaped signal Bipolar Cut 1 130 watt continuous sine wave Bipolar Coag 1 140 watt continuous sine wave Bipolar Pulse 1 130 watt continuous sine wave Visual and acoustical signals Green switch light X Green working indicator __ Continuo
26. e acne 36 9 3 8 Gurrent Leakage 16Std lali e au ie tl adt 36 9 3 6 Test of handpiece allocation re Ne 36 9 3 7 Test of patient electrode recognition esses eene 36 PROT FICS aui ea a 37 not valid for MBC600 4 27 04 04 Soring Users manual RF units 1 Introduction This operating manual describes the function and handling of the Radio Frequency Surgery Equipment MBC The manual serves as an instruction reference and should be read thoroughly before operating the equipment Only then can the correct handling of the equipment be assured In case of incorrect handling no liability will be taken on by the manufacturer MBC s are RF surgery equipment conforming to DIN IEC 601 part 1 respectively EN60601 1 utilized only for rooms for medical use Every important function is controlled and supervised by a microprocessor The MBC units in MONOPOLAR MODE are meant for the use in general surgery and gastroenterology In MONOPOLAR MODE operations on the heart eyes and in the brain neurosurgery are not admissible This equipment has not been developed for continual operation constant power supply for a longer period The period for use fulfills the demands for operation of the EN60601 2 2 10s load 30s break This RF Surgery unit meets the requirements of the EMC guideline 93 42 EWG of the European Community and is therefore labeled with the sign Before starting operatio
27. eriosteum and spreads only slowly deeper below the tip of the electrode If however the heat developed is extended to a larger area due to a larger contact surface between active electrode and tissue boiling of the tissue fluids occurs together with widespread albumin coagulation Depending on the used current intensity either depth coagulation see Fig 3 3 or a surface coagulation see Fig 3 4 with eschar generation is achieved Due to bad thermal conductivity of eschar heat transfer especially into the depth is prevented by eschar formation not valid for MBC600 10 27 04 04 Soring Users manual RF units active electrode coagulated tissue Nn Tu RSS A AT IN a e NN IN I WU Fig 3 3 Schematic representation of electro coagulation on a homogenous tissue The boiling extends to a depth somewhat larger than the diameter of the electrode It is strongest underneath the electrode At the surface it also extends to the surroundings of the electrode rim effect active electrode generated eschar coagulated tissue ul JN hw Fig 3 4 Schematic representation of electro coagulation with generated eschar In this case the current value used for electro coagulation is too high Close to the electrode a coagulation of tissue is initiated so rapidly that eschar is created the isolating effect of which prevents a deeper electro c
28. h the electrical resistance offered by the biological tissue and through the heating of the electrode 3 1 Heating effect of RF currents in biological tissue The heat production is mainly a result of the fact that biological tissue acts as an electrical resistor for frequencies normally used during RF surgery and that as an electrical resistor biological tissue heats up when electric currents flow through The amount of heat developed is therefore dependent on the current and the resistance of the conductor the biological tissue put up by the patient From the electrical point of view the patient is the conductor The material of the conductor and its geometrical shape influences the resistance of this conductor In this connection a comparison of specific resistance of metallic conductors and biological tissue is of interest Table 3 1 clearly shows that the specific resistance of metals is much smaller than that of biological tissue As a result in a closed current loop of metallic conductors and biological tissue of equal cross sectional area the biological tissue heats up significantly more As can be seen in the table below different biological tissue types offer a wide range of electrical resistance and thus are affected differently by the applied RF signal The MBC internal circuitry automatically senses the resistivity and adjusts the RF signal accordingly for the best results Biological Tissue Metal 2 in the range 0 3 to
29. he signal will be in the cutting mode and part in the coagulation mode When you keep pressing the button for around 1 5 sec BL and a value from 1 9 will light up in the Cutting display Thus coagulation degree the coagulation duration can thus be varied by the arrow keys in 9 steps from 1 few up to 9 strong A setting of 5 results in a 50 50 combination of cutting and coagulation modes A setting of 9 means that about 9096 of the time the signal will be in the coagulation mode Pulse When pressing the Pulse button the cutting current will be delivered in a pulsed form in order i e to cut off a diverticla cleanly with loop electrodes The pulsing power alternates between high cutting power and lower coagulating power Thus cutting is followed by coagulation The duration of the coagulation phase can be adjusted by pressing the Pulse button for around 1 5 sec PL and a value from 1 9 will light up in the Cutting display The coagulation phase duration can be varied by the arrow keys in 9 steps from 1 few up to 9 strong Pulse TUR In case both keys are activated a pulsed cut under water can be performed The power for cutting will be increased and the current is delivered in a pulsed form in order i e to cut off diverticles cleanly with loop electrodes with under water Due to the pulsed waveform an additional coagulation effect is achieved during cutting Function keys for monopolar Coagulation modes These pushbuttons select the desired
30. it is switched off Basically two user steps have to be distinguished The setup of the wanted values and its storage Load and use wanted program 5 1 Description of controls and indicators 3 Monopolarconnecting socket O 6 Functionfield coagulation O 8 Safety field gt O 9 Function keys mono Cutting sd Function keys bipolar Pulse Autostop Auto Power display of step Autostop gt i Program functions not valid for MBC600 22 27 04 04 A S ring Users manual RF units Power switch Connection for patient electrode See also chapter 4 2 and chapter 5 1 1 This RF equipment has patient electrode monitoring which checks the correct attachment of the patient electrode to the patient For this purpose the use of a split patient electrode is necessary If a non divided patient electrode is used only the connection between patient electrode and equipment is monitored Connecting socket for cutting and coagulation Handpieces for the function fields Cut and Coag are connected to this socket Handpieces with or without finger switches are usable Connecting socket for Bipolar Surgical instruments for bipolar applications are connected to this socket Function field Cut The output power is divided into 5 default steps To use power settings between each of the default steps you can use the arrow keys 14 When pressing the arrow UP button the display counts up when pres
31. lication of electro surgical instruments and metal clips on hollow organs with small cross sectional areas is dangerous and may cause coagulation necrosis Directly grounded monitoring equipment e g pulse monitoring clips should not be used as burns may arise When RF surgery is applied to persons with implanted cardiac pacemakers or electrodes irreparable damage to the pacemaker or disturbance of the pacemaker function together with ventricular flutter may happen In case of doubt the cardio logical department should be consulted The patient is also endangered when a cardiac catheter is present during an electro surgical operation micro shock because if the connection of the patient electrode to the RF equipment is interrupted part of the current may flow directly through the heart Instruments electrodes not in use must be kept a far distance from the patient not valid for MBC600 19 27 04 04 Soring Users manual RF units Arrangement of Switches Sockets and displays of MBC 601 Sicherheit Safety MONO CUT PROG 5 S ring Medizintechnik mm om Be BR 20 not valid for MBC600 27 04 04 Soring Users manual RF units Arrangement of Switches Sockets and displays of MBC 600 13 Sicherheit Safety
32. n 3 If repaired does danger no longer exist 4 Has new knowledge been gained which will make other or additional safety provisions necessary 2 7 Modifications and repairs Modifications and repairs must not reduce the safety of the equipment and accessories for the patient user or the environment Therefore modifications and repairs to this equipment must only be carried out by the manufacturer or by persons explicitly authorized by S ring If non authorized persons perform unqualified modifications and repairs to the equipment or accessories the manufacturer will not accept liability Furthermore in this case the warranty expires not valid for MBC600 7 27 04 04 Soring Users manual RF units 3 Physiological and physical fundamentals of RF Surgery Thermocautery as an aid to mechanical operation techniques began many years ago with the application of heated metal tools to wounds to control bleeding The technique was found to be very effective Later the use of electrical power to effect electro cauterization and cutting of tissue was the next logical step RF Surgery is the use of high frequency alternating electrical current frequency higher then 300 kHz with the purpose of alteration or destruction of cells and for cutting tissue It is used for tissue removal and cauterization in connection with mechanical operation techniques The tissue cauterization and cutting effects are accomplished by a combination of heating throug
33. n of the patient electrode at the patient A good connection of the patient electrode is indicated by the illumination of a green LED A yellow LED indicates deterioration of transfer resistance between patient tissue and patient electrode The equipment can be activated further however the proper fit of the patient electrode should be checked If the patient electrode is not connected or has a bad connection to the patient the red LED blinks Additionally a warning signal sounds twice if the connection is broken or if an attempt has been made to activate the equipment The equipment switches off and cannot be reactivated Only after correction of the patient electrode is reactivation possible If a single surface patient electrode is used this is indicated by the illumination of the green and yellow LED s 2 Functional error This warning device signals that the pre selected parameters are not met by the equipment i e a significant exceeding of the selected output power When this condition reaches critical values which may endanger the patient additionally an alarm signal sounds and the equipment switches off After switching on during a self test the micro controller senses an error a warning tone sounds the equipment function is disabled and an error code is displayed 3 Dosage error If due to overload the equipment respectively the selection of a too low power step in relation to the surface size of the electrode an insufficient output
34. n the appropriate handpieces must always be checked for external damage The Soring Company only accepts liability if accessories from the Accessories Order List were used At the end of the normal life cycle of the unit it should be taken to either a legitimate electronics disposal site or to the Soring Company Symbols Used Patient electrode when RF applied patient Defibrillator save electrode electrode insulated against earth Attention see also covering Monopolar Cutting amp Coagulation documents Off separation from main power Bipolar Cutting and Coagulation supply On connection to main power supply 97 Potential equation pin 2 Attention high voltage v type CF CE label acc To 93 42 EWG 0123 not valid for MBC600 27 04 04 Soring Users manual RF units 2 Important notes regarding the operation of RF Surgery units During operation of RF surgery equipment disturbances of other electronic devices may occur due to generated interfering signals 2 1 Operating of RF Surgery Equipment The user is only allowed to operate such RF Surgery Equipment after the manufacturer or the distributor has 1 Checked the equipment for faultless function at the location of operation and 2 Introduced the person responsible to the operation of equipment according to the instruction manual 2 2 User instructions RF Surgery equipment is only to be operated by persons who h
35. nt does not flow through the body of the patient but directly to a second adjacent electrode of the surgical instrument e g a tweezers leg The advantage is that the RF current only flows in an area where the surgical effect is wanted so that damage to the surrounding tissue is largely avoided Further advantages are the low power requirement and a low disturbance effect e g on measurement equipment Fig 3 8 shows a schematic representation of bipolar application technique Isolation Insulation Isolierter Pinzettenschenkel Insulated Tweezers leg Pinzettenspitze als Aktivelektrode Tweezers Tip as Active electrode Pinzettenspitze als Neutralelektrode Tweezers Tip as Patient electrode Fig 3 8 This equipment provides the application techniques bipolar cutting and bipolar coagulation As described in the previous chapters 3 2 1 and 3 2 2 a continuous signal is also used for bipolar cutting The coagulation occurs with a lower RF voltage 3 2 5 1 Bipolar Automatic When the automatic function of bipolar been selected the equipment switches on and off auto matically for coagulation of tissue as soon as a Sufficient tissue contact between the tweezers legs has been recognized by resistance measurement If required the system can be switched off so that the bipolar instruments can be activated by the footswitch see also chap 5 1 point 7 ATTENTION Do not use Bipolar Automatic
36. oagulation Due to eschar the electrode sticks to the tissue not valid for MBC600 11 27 04 04 Soring Users manual RF units 3 2 Methods of RF Surgery and electrical Signal Shapes Cutting and coagulation modes of RF surgery depend in part on the shape of the sine wave of the electrical current The frequency is remains around the 350 kHz range but the current amplitude power is changed to meet the surgical demands A cutting current is a continuous sine wave The amplitude is varied to accommodate the tissues being cut as each tissue type has a different electrical resistance A coagulating current has a diminishing sine wave form repeated over intervals of time parts of a second and at varying sequence frequencies to achieve selected levels of coagulation In the initial phase of a coagulation event the amplitude of the current is high and then falls to zero or almost so If such a current could be heard it might resemble the sound of a ringing bell See Figure ZZ 3 2 1 Cutting The cutting effect is based on the principle of cellular rupture This is accomplished by a rapid and locally limited temperature rise causing an explosion like vaporization of intra and extra cellular fluids which ruptures cells and fractures cell connections Under ideal conditions no coagulation occurs at the cut and the surfaces of the cut do not show the typical light color of a coagulation seam Principle of cell destruction The shape of the ele
37. on inflammable and non explosive cleaning and disinfection agents Care should be taken that no liquids soak into the equipment ATTENTION The following points are only valid for S ring products Handpieces Handpieces as well as their cables and connectors should be treated with non inflammable and non explosive cleaning as well as disinfection agents They are autoclavable up to 134 C Reusable patient electrode The silicon electrode including cable and connector are autoclavable up to 134 C Footswitches IPX8 AP Footswitches may be treated with all common cleaning and disinfection agents but may not be autoclaved not valid for MBC600 31 8 Technical Data Mode Power output into 2 S ring Output range W Nominal Frequency kHz Users manual RF units Output Volt Vep Cut 1 Cut 2 Cut 3 Cut 4 Cut 5 10W 2009 70W 2002 130W 2002 210W 2009 320W 2009 10W 2002 60W 2000 120W 200Q 180W 2000 250W 2000 TUR1 TUR2 TUR3 TURA TUR5 10W 2000 70W 2002 150W 2000 250W 2002 350W 200 2 7W 2002 14W 2000 22W 2000 31W 2002 40W 2000 TUR Pulse1 TUR Pulse2 TUR Pulse3 TUR Pulse4 TUR Pulse5 8W 2000 16W 2000 26W 2002 38W 2000 50W 2000 5W 2000 30W 2002 55W 2000 Soft 4 80W 2000 Soft 5 120W 1000 Output voltages are no load values Soft 2 Soft 3 vlo x m m amp m 9 S IE IE JL IE os o l D D s l
38. ontact surface for the patient electrode has to be cleaned degreased and freed from strong growth of hair if necessary in order to obtain a low transfer resistance Alcohol should not be used for skin cleaning because it dries out the skin and causes increased transfer resistance at the contact area of the patient electrode The contact area of the patient electrode should be moistened by carefully rubbing the skin with a salt solution in order to obtain a good conductivity Spraying should be avoided because in this case salt solution could get underneath the patient not valid for MBC600 16 27 04 04 Soring Users manual RF units Fig 4 3 Moistening of body parts for fastening of patient electrode According to manufacturer s specification the patient electrode must have a clean surface free of corrosion and oxides in order to keep the transfer resistance as small as possible Furthermore the surface area of the patient electrode must be sufficiently large so that no unacceptable heat will develop In case of insufficient blood circulation the skin shall be massaged or brushed at the contact area before applying the patient electrode It should be mentioned that for long lasting operations disturbed blood supply around the patient electrode might come up again which leads to an increased transfer resistance If the transfer resistance at the patient electrode increases during an operation the contact area heats up
39. orceps is automatically recognized and the HF generator is activated A measurement of the resistance is carried out for coagulation The generator will be turned off if the tissue impedance is higher than 3 5kohm good coagulation result latestly after the maximum time of 5sec In automatic mode coagulation function is pre selected If cutting has to be performed in automatic mode one of the power step selector buttons for bipolar cutting has to be activated In order to go back to coagulation one of the power step selector buttons for bipolar coagulation has to be activated The recognition of tissue contact is indicated to the user by a short signal tone and the RF generator starts A tissue contact is recognized if the tissue resistance between the forceps legs is in the range of approx 40 to 10002 Bipolar Pulse Button The use of the Pulse function allows a controlled cutting with bipolar loop electrodes Due to the coagulation contribution bleedings will nearly not occur f e in polypectomy To select this function just press the PULSE button Now the cutting power BIPO CUT and the coagulation contribution BIPO COAG can be set independently from each other The maximum power output is given by the sum of the two bipolar values Due to the limitation of the total power to 130w a higher setup is not possible When the unit is activated by the CUT pedal both LED s CUT amp COAG will light up Bipolar power indicators and set up keys
40. peed so that the intra and extra cellular fluids are vaporized without destroying the cell membranes By this loss of fluid the cells contract and the cell membranes are welded together This kind of coagulation is often called contact coagulation because the electrodes shapes are balls or plates are brought into direct contact with the tissue A supply of RF current causes a light coloring of the tissue and a flow out of tissue fluid due to coagulation of cellular albumin 3 2 3 Electrodessication Electrodessication is a special mode of coagulation and is nowadays called Spray coagulation By means of a very high RF voltage sparks or arcs between electrode and tissue surface are not valid for MBC600 13 27 04 04 Soring Users manual RF units generated and no direct contact is necessary The spark over causes an extreme temperature rise in the tissue areas close to the surface and destroys them surface coagulation eschar carbonization Electrodes with a small area like small ball or needle electrodes are used The necessary high voltage with moderate RF power is reached by high pulse modulation Peak voltages up to 9kVpp are obtained by this method Spray coagulation is mainly used for a quick and widespread coagulation of tissue e g with seeping hemorrhage It should be noted that the frequently generated eschar causes bad healing and after bleeding 3 2 5 Bipolar application technique With bipolar application the RF curre
41. play For handpieces which are not connected the display shows If the PROG button is pressed a second time the stored values will be shown in the displays and can be queried independent of the handpiece Please keep in mind that after the selection of a program the values can not be changed except for a fine tune by the Up and Down buttons and a change of the program Ill Working with chosen program and adding new adjustments Switch on the unit and connect all needed handpieces Choose a program and start to work with the activated program As an indicator of the program mode the relevant button in either the CUT or COAG field is illuminated To change parameters within this program now the CUTT button has to be pressed and held Simultaneously the PROG button has to be pressed According to this the unit switches into the basic state and all adjustments can be changed If several footswitch activated handpieces are adapted an activation of the panel modules is only possible via the arrow keys To store these changes please follow as described under 1 IV Erase program adjustments Switch on the unit and connect all needed handpieces not valid for MBC600 26 27 04 04 Soring Users manual RF units CUT1 button has to be pressed and held Press PROG button shortly and let off CUT 1 button The CUT display shows now ErA By pressing one program button 1 10 the relevant program will be erased the
42. ring electrodes with areas as large as possible should be used instead For simultaneous operation of EKG and RF surgery equipment power outlets 230V close to each other and connected to the same or adjacent power circuits should be used in order to avoid dangerous current loops which may originate from outlets situated far apart from each other are not conducted parallel to EKG cables risk of capacitive current coupling and do not present obstacles or stumbling risks to the OR staff not valid for MBC600 Active electrode 18 Active electrode Fig 4 7Positions of cables and patient electrode in RF surgery 27 04 04 Soring Users manual RF units 4 5 Dangers from inflammable and explosive media In RF surgery development of sparks at the active electrodes cannot be avoided If inflammable or explosive agents for e g anesthesia skin cleaning degreasing and disinfection or endogenous gases e g within the gastrointestinal tract are present RF surgery must not be applied because of fire and explosion hazard For application of RF surgery all media necessary for the operation should therefore neither be inflammable nor explosive at least these media should be completely evaporated and removed from the area of sparks wait at least 10 seconds before switching on the RF surgery equipment There is a risk of inflammable fluids gathering underneath the patient or in cavities of the body e g the navel
43. se holder for the main fuses of the equipment The value of the two glasstube fuses is given on the type label Type label The type label contains supply data serial number type of equipment and fuse size not valid for MBC600 25 27 04 04 19 20 21 Soring Users manual RF units Connection for potential equalization Connection pins for potential equalization cable between RF equipment and potential equalization bar in OR room The yellow green potential equalization cable supplied by the manufacturer must be used Connecting socket for double pedal footswitch This is the footswitch connector for operation of monopolar applications of Cutting and Coagulation as well as for operation of bipolar function A footswitch must be connected in case a monopolar handpiece without a fingerswitch or the bipolar channel shall be used When the double pedal footswitch is connected the bipolar field is active with priority The LED s within the monopolar coagulation and cutting field are not switched on If a mono polar handpiece without finger switches shall be used pressing any key of the coagulation field may activate the monopolar function fields In this case the indicators of the bipolar channel extinguish and the monopolar function fields are active To reactivate the bipolar mode press any key within the bipolar field see operation facilities PROGram function I To store a program the following steps have to be taken
44. sing the arrow DOWN button the display counts down The displayed value is the maximum power output in watts see Technical Data chapter 8 Function field Coagulation MBC 601 offers 2 separate adjustable channels 10a 10b The output power is divided into 5 default steps To use power levels between each of the default steps you can use the arrow keys 14 When pressing the arrow UP button the display counts up when pressing the arrow DOWN button the display counts down The displayed value is the maximum power output in watt see chapter 8 Function field Bipolar Field for bipolar applications of Cutting and Coagulation The bipolar functions coagulation and cut are activated by a double footswitch or through an automatic mode When using the footswitch option the RF generator stays active as long as the footswitch is pressed This is the standard mode after switch on The coagulation function can alternatively be activated via fingerswitch if corresponding instruments are used If the automatic button is pressed then coagulation occurs whenever resisting tissue is captured and detected between the forceps legs The coagulation is automatically stopped when the tissue is adequately coagulated as detected by the increasing electrical resistance of the dried coagulated tissue tissue impedance higher than 3 5kohm latestly after the maximum time 5sec Bipolar Coag MBC 600 only To adjust the power level use the default buttons to go immedi
45. the cutting velocity the condition of the tissue and the shape of the current not valid for MBC600 12 27 04 04 Soring Users manual RF units smooth Cut rich of Cut with eschar cut coagulation Fig 3 6 The smooth cut is largely comparable to the cut with a conventional scalpel i e the cutting surfaces are only slightly colored This cutting mode is achieved with unmodulated RF current and by carrying out the cut quickly A reduction of cutting speed gives a more coagulated cut even to the point of eschar with enough speed reduction The same result is achieved when using a pulse modulated RF current with the same average power The power necessary for performing a RF cut depends on the shape of the electrode type of tissue and its resistance If the power is too low no cell rupture takes place and the tissue sticks to the electrode If the applied power is too high spark discharges between electrode and tissue are possible which causes carbonization of the cut surfaces 3 2 2 Coagulation For coagulation the tissue is heated more or less to such a degree that no cell rupture occurs The temperature for coagulation is above 50 C This temperature leads to a coagulation of the intra and extra cellular albumin boiling of tissue Perforated blood vessels contract so far that the vessel is totally closed and no blood flows out In order to obtain this effect the electric current must heat the tissue at a sufficiently slow s
46. us tone 440Hz X Green working indicator Continuous tone 480Hz__ Bipolar cutting Green working indicator Continuous tone 550 Hz Bipolar Coagulation X Green working indicator Continuous tone 550Hz patient electrode a Red blinking signal Modulated warning tone 370Hz error dosage error Red signal The level of the acoustical signal is adjustable between 45 and 65 dB A The level of the warning tone Patient electrode failure is fixed at 65 dB A Autostop time Auto 1 5sec not valid for MBC600 33 27 04 04 Soring Users manual RF units Error codes Further data see service manual If occurring problems can not be solved by the service technician in the hospital please call the S ring Company at 682 531 0950and transmit the error code and the serial number of the unit Basically the error code is indicated in the left most 7 segment display The indication is divided into the function group i e 1 and the function i e 2 separated by a dot Power supply data Mains voltage 230V 50Hz Internally switchable to 115V 60Hz Mains fuses Built into main filter containing 2 fuses T 4A 250V slow blowing according to IEC127 for 230V main voltage Respectively T 8A 250V slow blowing for 115V main voltage Mains cable Length 2 5 m with protective conductor mains part according to DIN 49 441 resp CEE 7 p VII Equipment part according to DIN 49 457 1 Plug and socket vulcanized to ca
47. voltage is reached this red display lights up To switch LED off either increase the power or decrease the surface size of the electrode All units have short time storage of the adjusted values during power failures If the power fails for less than 8 seconds the unit will store the last adjusted working parameters When the main power is back on the unit will deliver these values after a short self check not valid for MBC600 27 27 04 04 Soring Users manual RF units 5 2 Putting the equipment into operation To become familiar with this equipment the user should carefully read this chapter This is especially important when operating the equipment for the first time in order to avoid mis operations 5 2 1 Description of operational facilities The functions Cutting and Coagulation can be activated by the finger switch as well as by the footswitch The function fields Bipolar and the monopolar function fields that shall be used in connection with handpieces without finger switches are activated by the double pedal footswitch Monopolar handpieces with finger switches and a bipolar instrument can simultaneously be connected to the equipment and can be operated without further contro of the equipment The bipolar instruments will then be activated by the double footswitch A simultaneous connection of monopolar handpieces without finger switches and bipolar instruments with the double footswitch provided for this purpose is basicall
48. wer outlet It is recommended to not connect the BNC cable before the unit has finished its self test Depending on the chosen possibilities in 5 2 1 the double pedal footswitch is connected to socket 2 the monopolar handpiece to socket 3 and the bipolar instrument to socket 4 5 2 3 Switching on the equipment After activating the power switch 1 the green LED indicates the presence of supply voltage After completion of the automatic self test around 2 min the following initial parameters are indicated in the function fields as pre set values Monopolar Cut Step 1 Monopolar Coag Soft Step 1 not valid for MBC600 28 27 04 04 Soring Users manual RF units Bipolar Cut Step 1 Bipolar Coag Step 1 Only after the self test the instruments should be adapted If the monopolar handpiece is connected and the patient electrode is not connected the red patient electrode indicator blinks in the safety field Settings in the function field are possible However activation of the equipment is not possible see chapter 5 1 If in spite of this an attempt is made a warning signal sounds 5 2 4 Adjustment of function fields After switching on the equipment the function fields are in the state described in 5 2 3 By simple activation of keys or the adjustment control in the function fields the desired output characteristics can be chosen see Chap 5 1 not valid for MBC600 29 27 04 04 Soring Users manual RF units 6
49. y possible This mode of operation however is not recommended by the manufacturer because the footswitch may only be allocated to either the monopolar or to the bipolar function In this case only the indicators of one function are switched on For function change bipolar monopolar an arrow key in the not activated function field has to be pressed If it is intended i e to switch from bipolar to monopolar only one arrow key in the monopolar function fields CUT or COAG has to be activated Pressing an arrow key in the bipolar field then re activates the bipolar mode The following operational facilities can be chosen Monopolar Cutting and Coagulation Connecting socket 3 Monopolar handpiece with switches yellow amp blue Or Connecting socket 3 Monopolar handpiece w o switches Connecting socket 3 Monopolar cable for endoscopic instruments Connecting socket 20 Double pedal footswitch Bipolar Cutting and Coagulation Connecting socket 4 Bipolar instrument Connecting socket 20 Double pedal footswitch 5 2 2 Preparation of equipment First of all check that the supply voltage shown on the type label 18 corresponds to the main voltage Only then may the equipment be connected to the main power source and switched on The potential equalization cable is connected to the provided connector 19 and to the potential equalization of the OR room The power cable is connected to the power socket 17 and a grounded po
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