Quantum 2000 Electrosurgical System User Manual
Contents
1. RF 3 V m 3 V m frequency of the transmitter IEC 61000 4 3 80 MHz to 2 5 GHz Recommended separation distance d 33 Ve V 1 TM B 80 MHz to 800 MHz 1 a PIE 800 MHz to 2 5 GHz E 1 where P 1s the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol o NOTE 1 Ar 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the Wallach Electrosurgical Generator are used exceeds the applicable RF compliance level above the Wallach Electrosurgical Generator should be observed to verify normal operation If2. abnormal performance is observed additional measures may be necessary such as reorienting or relocating the Wallach Electrosurgical Generator Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m 37962 Rev A 9 13 Wallach Surgical Devices 27 WALLACH 95 Corporate Drive Trumbull CT 06611 USA Phone 800 243 2463 203 799 2000 Fax 203 799 2002 customerservice wallachsurgical com www wallachsurgical com 37962 Rev A 9 13 Wallach Surgical Devices
3. any monitoring cable or patient connected tubes such as I V lines etc the crossing should be at right angles Use of monitoring systems incorporating high frequency current limiting devices is recommended CUTTING TECHNIQUES When cutting always activate the electrode by stepping on the footswitch or pressing the yellow button on the handpiece before contacting the tissue Plan the stroke Before activating the electrode take one or two practice strokes to be sure you can complete the planned stroke comfortably and correctly At this time you can evaluate the size and shape of the electrode and the speed and depth of the stroke When the practice stroke 1s comfortable step on the footswitch or press the yellow button on the handpiece and make the planned cut 37962 Rev A 9 13 Wallach Surgical Devices 11 Use a smooth brushing motion without pressure The electrode should pass through the tissue without dragging at a deliberate but not slow speed Keep the electrode moving Prolonged contact with any one part of the tissue can create excessive coagulation CUTTING Blend Cutting 1s done not by the electrode but by the high frequency energy concentrated at the electrode This high frequency energy generates molecular heat in each cell to the point where the fluids in the cell vaporize and the cell explodes By applying this energy to individual cells in sequence that 1s by moving the electrode continuously through the t
4. handpiece is actuated the R F ON lamp will illuminate and the beeper will emit a pulsing tone The system is ready for use and the System Ready LED will illuminate green If the operator feels the output of power 1s not sufficient the dispersive electrode split pad should be checked to see that good contact 1s made with the patient before increasing the power setting CROSS CONTROL The sequence of operation of the Quantum 2000 is nonpreferential that 1s either the footswitch pedal or the handswitch will activate the output providing all safety measures are met The footswitch and the handswitch cannot be operated simultaneously IMPORTANT If using footswitch the button on front panel must be used to control the Output mode When the Coag mode is selected on the front panel the Cut or Blend modes cannot be invoked by the handswitch yellow button The Cut mode if desired must be selected on the front panel and then invoked either by the handswitch or the footswitch operated pencil 37962 Rev A 9 13 Wallach Surgical Devices WARNING Positive contact must be complete between the patient and the erounding pad If a Split Pad is not securely affixed to the patient the Patient Pad Loose indicator LED Red will indicate an improper return path The Patient Pad Loose safety circuitry disables the output when an unsafe condition occurs in the return pad circuit If a single not
5. in Ur for 25 cycles 5 Ur 795 dip in Ur for 5 sec Electromagnetic Environmental guidance Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment If the user of the Wallach Electrosurgical Generator requires continued operation during power mains interruptions it is recommended that the Walach Electrosurgical Generator be powered from an uninterruptible power supply or a battery Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment NOTE Ur is the a c mains voltage prior to application of the test level In this case 230 V 37962 Rev A 9 13 26 Wallach Surgical Devices Immunity IEC 60601 Compliance Electromagnetic Environmental Guidance Test Test Level Level Note 1 amp 2 Conducted RF 3 Vrms 3V Portable and mobile RF communications equipment should be IEC 61000 4 6 150 kHz to 80 MHz used no closer to any part of the Wallach Electrosurgical Generator including cables than the recommended separation distance calculated from the equation applicable to the Radiated
6. it is returned Items that are not sanitized will be returned to the customer freight collect All shipments must be made via pre paid parcel post or U S Mail C O D packages will not be accepted 37962 Rev A 9 13 Wallach Surgical Devices 16 TROUBLESHOOTING TROUBLE A On Off switch when in position does not illuminate B Patient Pad Loose intermittent power output or low power C R F Leakage Error D System Ready light green not on 37962 Rev A 9 13 N PROBABLE CAUSE Unit not plugged in Blown fuse N 1 Faulty application or poor contact 2 Improper placement 3 Worn insulation in electrical leads 1 Electrode touching grounding metal 2 Directly grounded 3 Insulation missing Improper connection One or more safety problems as indicated by other lamps or beeper 3 Product failure 17 CORRECTIVE ACTION Plug into wall outlet Replace fuse N Check full contact to patient 2 Place in accordance with instructions 3 Replace 1 Remove from metal 2 Locate faulty insulation between table equipment to patient 3 Locate faulty insulation m Connect correctly 2 Follow safety instructions 3 Return to Wallach Wallach Surgical Devices TROUBLESHOOTING continued TROUBLE PROBABLE CAUSE CORRECTIVE ACTION E 1 Electrical current not 1 Check all connections R F ON doesn t flowing light up 2 Footswitch defec
7. possible to get a clinical effect to combine or blend the clinical characteristics of CUT and 37962 Rev A 9 13 Wallach Surgical Devices COAG yielding the effect referred to as blend where tissue 1s divided with a desirable amount of hemostasis along the margins of the divided tissue The Quantum 2000 has output load characteristics that cause the electrosurgical effects to remain consistent throughout the procedure However under some circumstances it may be necessary to readjust the power settings during the procedure ATTENDANT RISKS OF HIGH FREQUENCY ELECTROSURGERY Electrosurgery produces sparks which can ignite flammable materials This includes solvents adhesives gauze cotton and also liquids and gases Further risks include e Pooling of flammable agents under the patient in body depressions in body cavities e Oxygen saturated gauze and cotton wool e Accumulated oxygen gas under covers drapes or clothing e Ignition of endogenous gases in or near body cavities or osses ELECTROSURGERY Electrosurgery 1s the use of energy created by a high frequency alternating current The resistance of the tissue to the passage of this current creates heat internally in the tissue as in diathermy Monopolar electrosurgery involves the use of two electrodes an active electrode and a patient return plate or dispersive electrode of greatly different sizes This results in greatly increased current density at the point of t
8. purge operations removing excess smoke take only a few seconds SET UP AND OPERATION OF THE WALLACH QUANTUM 2000 PRACTICE In the following section cutting and coagulating are described First practice methods are suggested including how to adjust the settings for optimal cutting and coagulating Then general techniques are described which should help determine and develop the best specific techniques 1 Place the console on a flat stable surface near the Wallach Biovac Smoke Evacuator Connect the AC power cord s accordingly Plug the removable footswitch into the front panel if foot control is desired Set it up in a convenient low traffic area 2 Place the ON OFF switch to OFF and plug the console into a grounded 115 VAC electrical receptacle This 1s an important safety feature 3 Useonly Wallach approved disposable accessories See page 15 for further information 37962 Rev A 9 13 Wallach Surgical Devices 4 5 6 7 8 9 10 11 Remove the disposable patient return electrode from 1ts packaging and attach 1t to the patient in accordance with the instructions Be sure to follow all instructions regarding the location of the pad ensuring that good contact Is made with the patient Attach the disposable patient return pad the patient electrode securely into the black receptacle on the front panel of the instrument Insert the disposable active electrode handpiece into the black recepta
9. split return pad is not securely affixed to the patient severe return electrode burning of tissue in the vicinity of the return pad may result Poor connections or insufficient contact area can cause undesirable R F burns The entire area of the grounding pad should be reliability attached to the patient s body and as close to the operating field as possible However it is not recommended that a single not split pad is used Use only approved Wallach split return pads 12 Cable Placement High frequency cables should be routed clear of other instruments and arranged for minimum length Cables to surgical electrodes should be positioned to prevent contact with PATIENT or other leads Temporarily unused active electrodes should be stored in a location isolated from PATIENT R F LEAKAGE The Quantum 2000 has a sensitive error detection mode that disables the output and indicates that an error condition exists by illuminating the front panel R F Leakage Error LED red This LED will indicate that an undesirable path exists from the return or active electrode to Ground In this context Ground means any undesirable path or place If such a path exists the patient should be inspected for any contact with metallic paths to tables chairs or other Non Isolated objects The purpose of this feature 1s to prevent R F current from flowing in undesirable places where it could either cause burns or damage to ancillary equipment 13
10. the Medical Device Directive 93 42 EEC Authorized Representative in the European Community Leisegang Feinmechanik GmbH LeibnizstraDe 32 D 10625 Berlin GERMANY Wallach and Quantum 2000 are trademarks of CooperSurgical Inc O 2013 Wallach Surgical Devices 37962 Rev A 9 13 Wallach Surgical Devices 24 EMC COMPLIANCE INFORMATION WALLACH Q2000 ELECTROSURGICAL GENERATOR MEDICAL ELECTRICAL EQUIPMENT needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the ACCOMPANYING DOCUMENTS Portable and mobile RF communications equipment can affect MEDICAL ELECTRICAL EQUIPMENT GUIDANCE AND MANUFACTURER S DECLARATION ELECTROMAGNETIC EMISSIONS The Wallach Electrosurgical Generator 1s intended for use in the electromagnet environment specified below The customer or the end user of the Wallach Electrosurgical Generator should assure that it is used in such an environment Electromagnetic Enviroment guidance Test RF emissions Wallach Electrosurgical Generators use RF energy only for it internal function Therefore its RF emissions are very low and are not likely to CISPR 11 Group 1 cause any interference in nearby electronic equipment RF emissions Wallach Electrosurgical Generators are suitable for use in all Class A establishments including domestic establishments and those directly CISPR 11 connected to the public low voltage power supply ne
11. C CS ics rcr E 8 REL ee tutae adem MM UU M UM E nee 10 The Power AA 10 Cutie SEDI P PC 11 A A cus utt usto cust us dtt A 12 Crterimot Good Cutting Technique nin es ess en oa Sava dawades 12 CU AC I Oo XM PEE 12 Coasulatino ESC an iQue Lain et a dard dard dard dard ao ooo Soha datas dads 13 Technique dc A O O O O o o e OR 13 For OB G YN Pr dd dl 13 SG V ro l Vessels RR ERE 14 ANSIA ica 14 Biop A A A at 14 The Wallach Return Bleetrode eri 15 Es A A A O A dio 15 PRC CESS OE hallo 15 Disposable Hands witch Pencils 252325982 52m9 m n uui i 2 eMe 15 Matias 16 DEL VICE REI M mem 16 Trouble hoot ett HR 17 18 Specifications for Quantum 2000 eee nea eee 19 A crmute tara 20 Special Eeatutes uidi idit Sd ton td de uu S u u alia 21 Ss A 21 Environment Conditions SA AA 21 Power Output Characteristics ld 22 Power Output at Various Load Resistance Gunnin E EAEE 23 Explanation of Symbols 22b on he ecd eR ai 24 EMC Compliance intormation ii b de EE A 25 Guidance and Manufacturer s Declaration Electromagnetic Emissions 25 Guidance and Manufacturer s Declaration Electromagnetic Immunity ccccccccccecceeeeeeeeees 26 37962 Rev A 9 13 Wallach Surgical Devices INTRODUCTION Your Wallach Quantum 2000 Electrosurgical System is designed with the help of leading clinicians and researchers s
12. ECTRODE A return dispersive electrode must be used to operate the Quantum 2000 system The return electrode should be of the split or dual type to take best advantage of the safety features for preventing R F burns due to poor adhesion NOTE For optimum patient safety with the use of the Quantum 2000 system it is strongly recommended to use only authorized and genuine Wallach split dual dispersive return electrode pads Part Number 909078 No other return electrode pad has been tested or verified to the level of safety and performance of an authorized and genuine Wallach Quantum 2000 split dual dispersive electrode pad WARNING A one piece return pad is not recommended since the one piece pad is not continuously monitored for the integrity of the electrical connection established at the area of contact Patient injury may result MAINTENANCE After each use the unit must be cleaned and disinfected To sanitize unit wipe down with a disinfectant While the finish on the instrument cabinet will resist scuffing and the chemical attack of most acids and alkalies any liquids spilled on the cabinet should be wiped up immediately ACCESSORIES NOTE Use only genuine Wallach Quantum 2000 accessories dispersive pads hand switch pencils footswitch operated pencils and electrodes for optimal system performance and patient safety The use of non Wallach authorized and genuine accessories is not recommended nor have been tested and verif
13. PATIENT CONTACT Operator to patient contact by direct skin to skin contact could make an undesired leakage path Avoid skin to skin contact by insertion of dry gauze as necessary Electrically insulating gloves should be worn by the operator Unless absolutely necessary the patient should not be touched when R F power 1s activated Patient should not come into contact with grounded metal parts or parts with a higher capacitance to ground 1 e operating table supports etc Use of antistatic sheeting 1s recommended for this purpose THE POWER SETTING The operating mode cut blended cut coagulate or wait 1s selected by the mode selector buttons When a mode is selected the intensity should be set by depressing the POWER Raise or Lower buttons that control the digital display When a mode is selected the corresponding LED illuminates in the corner of each button to verify which mode 1s engaged 37962 Rev A 9 13 Wallach Surgical Devices 10 To insure correct operation of the instrument the colors are correlated to International Standards Wait Green Blend Yellow Cut Yellow Coag Blue When the footswitch 1s depressed or the handpiece buttons are pressed the R F ON will illuminate yellow If either the Cut pure or blend or Coagulation mode is selected and the footswitch 1s depressed the output will be active In the Wait mode there will be no output The piezo electric Beeper will i
14. WALLACH QUANTUM 2000 ELECTROSURGICAL SYSTEM REF 909075 120 VAC REF 909075 05W 220 VAC C oos6 WALLACH 95 Corporate Drive Trumbull CT 06611 USA Phone 800 243 2463 203 799 2000 Fax 203 799 2002 customerservice wallachsurgical com www wallachsurgical com 37962 Rev A 9 13 Wallach Surgical Devices TABLE OF CONTENTS A aaa 3 Waigo 4 Ths Devices a BE Dove uya ua ua aa a a ico aaa 4 Avoiding Unintentional Patient Burms uu u PHI elon ARI 4 Thermal Injury amp Defects of Tissue Treated with Loop Electrodes 4 Flammable Gases So UOTIS Du aeta bt nte tenen dd 4 Smoke From Procedure Contains Lave Cells senden dud 5 Patent Sino a Pacman it E DALE DARE DARE DADA AA O EEES 5 CAOS rs A AAA DS 5 Indications for Use OB GYN Applications 6 Contraindications for OB GYN Applications a 6 Eleetrosursical Eissue BECA AAA ID 6 Attendant Risks of High Frequency Electrosurgery 7 CA UR 7 Fundamentals ot BECA A LIA old fi ThesNeottve Bleettodes rari 8 Biovac smoke BEyvacuator Opa 8 Automatic Mode Option 8 Lu CTS UCtOTL us dU cn den du achat tern aa oes a eterna Rtn ters A 8 Set Up and Operation of the Wallach Quantum 2000 iene eee eee 8 PA
15. cle on the top right side of the Quantum 2000 Either the button control operated handpiece or the footswitch operated handpiece may be used The footswitch operated handpiece requires an adaptor to fit into the top receptacle Insert the selected electrode loop into the active electrode handpiece Place the ON OFF switch to ON A red indicator lamp on the console R F ON will indicate that the hold mode has been initialized After self check the green System Ready LED illuminates NOTE If the system does not cycle to the System Ready status and a series of prolonged audible beeps are heard turn the system off and check for faulty hand foot or panel switches See TROUBLESHOOTING section page 18 Section G of this manual for additional information Ensure patient 1s connected securely to the return electrode split pad before beginning WARNING POSITIVE CONTACT MUST BE COMPLETE BETWEEN THE PATIENT AND THE GROUNDING PAD IF NOT SEVERE BURNING OF TISSUE MAY RESULT THE ENTIRE AREA OF THE GROUNDING PAD SHOULD BE RELIABILY ATTACHED TO THE PATIENT S BODY AND AS CLOSE TO THE OPERATING FIELD AS POSSIBLE The output is selected by the mode selector buttons When a mode is selected the intensity should be set by depressing the Raise or Lower button If either cut pure cut blended cut or the coagulation mode 1s selected and the footswitch 1s depressed the output will be active When the footswitch or
16. e It is imperative that the physician carefully weigh the risks and benefits of treatment versus non treatment in contraindicated patients e Pregnancy e Gross invasive carcinoma of the cervix e A bleeding disorder e Acute or active inflammation of the cervix endometrium fallopian tube ovary or peritoneum cervicitis endometritis tubo ovarian inflammatory disease or pelvic inflammatory disease e Positive endocervical curettage or a lesion in which the endocervical limit cannot be visualized colposcopically e Less than 3 months postpartum e Equivocal cervical abnormality ELECTROSURGICAL TISSUE EFFECT Delivery of continuous sinusoid waveform currents through a small electrode at appropriate power levels can cause rapid heating of the intracellular fluids in the cells in close proximity to the electrode turning these fluids into steam The significant increase in volume approximately five times causes cellular structure to rupture creating the clinical effect of CUT with little or no hemostatic effort along the margin of the divided tissue Delivery of short duration pulses of R F currents through a small electrode at appropriate power levels can cause heating of intracellular fluids at a more gradual pace This allows evaporation of these fluids without rupturing the cellular structure creating the clinical effect of desiccation or COAG with the division of tissue By varying the pulse to an intermediate duration it 1s
17. e from that shown in the diagrams shown on pages 22 and 23 by more than 20 RF Leakage 100 MA MAXIMUM AT MAXIMUM POWER SETTINGS 37962 Rev A 9 13 Wallach Surgical Devices 19 INDICATORS PILOT LIGHTS INDICATOR LIGHTS POWER INDICATIONS ACOUSTICAL CONTROLS Patient Pad Loose R F Leakage Self Test Overload Wait Green Cut Yellow Blend Yellow Coag Blue Digital LED Display Piezo Annunciator Operator Push Buttons Remote Pencil Buttons Footswitch A C Power Pencil Jack Return Jack WALLACH 1 Pencil Jack Q patient PAD Loose N Q Fr LEAKAGE ERROR system Reavy RAISE O rron 3 LOWER T ed Return Jack TYPE BF EQUIPMENT FOOT SWITCH 6 i Footswitch 1 PURGE Turns on BioVac for 5 Seconds 2 RAISE Increases Power Setting 3 LOWER Decreases Power Setting 4 WAIT Stand by Mode 5 BLEND Cutting Mode Selection 6 CUT Cutting Mode Selection 7 COAG Cutting Mode Selection REAR PANEL e Main ON OFF Switch e AC Cord Connector e Fuse Holder 37962 Rev A 9 13 Wallach Surgical Devices 20 SPECIAL FEATURES 1 2 3 4 5 6 7 Electronic power level control Digitally derived waveforms Low inherent leakage Patient return monitor disables power automatically 1f pad 1s loose Regulated system performance traceable to NIST Standards Automatic smoke evacuator signal function sends signal to detector for automatic smoke evacuator actuation when generator 1s ac
18. ed by the ball electrode using electronically generated current This will seal all vessels which are held in the tips of the forceps NOTE Always contact the tissue before depressing footswitch or handswitch when using the coagulation current TECHNIQUE GUIDANCE FOR OB GYN PROCEDURES A The endocervix may not be included in the loop excision and the results of endocervical curettage ECC may not be predictive of either residual or invasive disease after loop excision procedures If the ECC is positive for dysplasia a standard cone biopsy should be considered B Loop excision procedures performed with small diameter wire loop electrodes produce multiple small pieces of cervical tissue and may provide a less acceptable tissue specimen for histopathologic analysis C Larger lesions involving multiple quadrants of the cervix are more difficult to remove with loop electrodes 37962 Rev A 9 13 Wallach Surgical Devices 13 SEVERED VESSELS Clamp the bleeder with a hemostat Using electronically generated current touch a ball electrode to any part of the hemostat Depress the footswitch pedal to activate the current for several seconds Then release the pedal and remove the electrode Be sure the current is set as high as is necessary to achieve coagulation After the application of coagulating current remove the hemostat Bleeding should have stopped if not repeat the procedure Suture ligation may be required if R F 1s u
19. end mode 100 Full 5096 Half 500 1000 1500 2000 Load Ohms Coag mode 100 Full 5096 Half 500 1000 1500 2000 Load Ohms 23 Wallach Surgical Devices EXPLANATION OF SYMBOLS zi A L gt gt E SSIF AS 3 C oos6 C US o 2G Sl pem CATALOG NUMBER SERIAL NUMBER ATTENTION See instructions for use DEFIBRILLATOR PROOF SYMBOL Indicates that the device will not be damaged 1f the defibrillator 1s active TYPE BF EQUIPMENT Type of equipment is a type B equipment with an F type applied part Type B equipment is a piece of equipment providing a particular degree of protection against electric shock particularly regarding Allowable leakage current Reliability of the protective earth connection Type F isolated applied part Applied part isolated from all other parts of the equipment to such a degree that the patient leakage current allowable in single fault condition is not exceeded when a voltage equals to 1 1 times the highest rated mains voltage is applied between the applied part and earth APPLIED PART SYMBOL Electrode that 1s connected to a patient s body HIGH VOLTAGE SYMBOL ALTERNATING CURRENT SYMBOL AC current EARTH GROUND FUSE Replace Only with Specified Type and Ratings MEDICAL EQUIPMENT WITH RESPECT TO ELECTRICAL SHOCK FIRE AND MECHANICAL HAZARD ONLY IN ACCORDANCE WITH UL60601 1 and CAN CSA C22 2 No 601 1 Product conforms to
20. he smaller electrode While the electrode itself remains cold the highly concentrated high frequency energy creates molecular heat inside each cell By the choice of electrodes and selection and adjustment of the current the operator controls the effect of this energy on the tissues to achieve the desired results CAUTION WHEN IN THE MONOPOLAR MODE KEEP THE VOLTAGE POWER AS LOW AS POSSIBLE TO ACHIEVE THE DESIRED END EFFECT due to the potential for capacitive coupling and inadvertent burning at high voltages With electronically generated electrosurgery current it 15 necessary to convert the sixty cycle alternating current available at the wall outlet to the high frequency current needed for electrosurgery This conversion Is accomplished by a high frequency generator The high frequency waveforms are precisely controlled for the various modes of operation The peak average and RMS values of the desired waveforms are generated in accordance with scientifically and empirically derived standards which are known to result in the desired effects FUNDAMENTALS OF ELECTROSURGERY As with any instrumentation or equipment used in your practice there are some fundamental principles that should be learned in order to use electrosurgery safely and effectively These principles apply generally to all procedures where electrosurgery is used Familiarize yourself with them 37962 Rev A 9 13 Wallach Surgical Devices THE ACTIVE ELECTRODES Be su
21. he solution has completely evaporated before using electrosurgery 37962 Rev A 9 13 Wallach Surgical Devices E F e Electrosurgery should not be used in the presence of flammable or explosive cases e tis recommended that only non flammable agents be used for cleaning and disinfection SMOKE FROM PROCEDURES CONTAINS LIVE CELLS WHICH MAY PRESENT BIOHAZARDS HIV ETC USE SMOKE EVACUATION DEVICE CONSULT THE PACEMAKER MANUFACTURER S LITERATURE AND THE PATIENT S PHYSICIAN BEFORE USING THIS INSTRUMENT ON A PATIENT USING A PACEMAKER CAUTIONS U S Federal law restricts this device to sale by or on the order of a physician This device SHOULD NOT be used without proper training and preceptorship When in the monopolar mode keep the voltage power as low as possible to achieve the desired end effect due to the potential for capacitive coupling and inadvertent burning at high voltages Adequate anesthesia is indicated for all electrosurgical procedures Inspect loop and ball for adequate insulation Avoid using electric extension cord danger of separation Use a smoke evacuator with this device This device generates high frequency energy that could under some circumstances cause interference to other equipment For situations where the MAXIMUM OUTPUT VOLTAGE is less than or equal to 1600V ASSOCIATED EQUIPMENT and ACTIVE ACCESSORIES should be selected that have a RATED ACCESSORY VOLTAGE equal to or greate
22. ied to the level of safety and performance of a genuine Wallach accessory Contact Wallach or your Wallach distributor for a list of current genuine Quantum 2000 accessories DISPOSABLE HANDSWITCH PENCILS AIl Wallach disposable handswitch pencils are sold sterile and are for single patient use only For the Wallach Quantum 2000 use only Wallach genuine Disposable Handswitch Pencils activated accessory with finger switch which comply with IEC 60601 2 2 4 edition Genuine Wallach Disposable Footswitch Operated Pencils and electrodes are available sold sterile and are for single patient use only If you have any questions or require specific accessories contact your Wallach Representative or local distributor A variety of genuine Wallach disposable electrodes and accessories are available Use only cables approved by Wallach Regular inspection is required for accessories including your electrode cables for damage to the insulation If damage is found the accessory should be replaced to assure safe operation 37962 Rev A 9 13 Wallach Surgical Devices 15 Only use accessories specifically made for the Wallach Quantum 2000 that are specifically designed for the safe and proper operation of this unit Use of alternate accessories or parts is not recommended have not been tested and verified and can result in unsafe operation of this unit WARRANTY The Wallach Quantum 2000 is supported by a one year warranty from date of purcha
23. issue the line of destruction is limited and the cutting effect 1s realized At the same time the capillaries are sealed resulting in almost bloodless cutting hence the term blended cut This Is the preferred cutting for OB GYN procedures Pure Cut This 1s almost like using a cold scalpel with very little or no hemostasis CRITERIA OF GOOD CUTTING TECHNIQUE There are three criteria of good cutting technique 1 The electrode should float through the tissue without dragging or resistance 2 There should be only very slight if any change in the tissue color due to dehydration or charring 3 No tissue shreds should adhere to the electrode COAGULATING The Quantum 2000 1s specially designed for high fulguration so tissue bleeders can be sealed without burning the uninvolved tissue Coagulation takes place when the high frequency current 1s applied to the tissue with a current density sufficiently concentrated to dehydrate the cells and coagulate their organic contents but without penetrating deeply into the tissue This procedure is almost self limiting since the surface coagulation first created protects the underlying tissue against excessive depth of coagulation Coagulation appears as a white spot on the surface of the tissue emanating from the point of contact to the ball electrode It is easy to determine the depth of coagulation since the depth is approximately equal to the lateral spread of coagulation I
24. n contrast to cutting when coagulating the ball electrode should contact the tissue before depressing the footswitch or handswitch Start with a LOW power setting 15 setting mode button to COAGULATION 37962 Rev A 9 13 Wallach Surgical Devices 12 Contact the surface of the tissue lightly with the ball electrode Depress the footswitch or handswitch to activate the current coagulating the area for several seconds Then release the footswitch or handswitch and remove the electrode from the tissue Notice the appearance of the tissue It should appear blanched Turn the power intensity up step by step repeating the procedure Observe the characteristics of the coagulated tissue with each setting The degree of coagulation obtained at a particular setting will vary with different tissue and different conditions Determine which setting 1s best for various procedures When treating any condition 1f proper coagulation is not apparent after one application immediately increase the intensity setting if the return pad 1s properly in place CAUTION Never repeatedly apply the current to the same area this may create heat and seriously damage underlying tissues COAGULATING TECHNIQUE The ball electrode is extremely useful when you are controlling hemorrhage When applied for a second or two electronic coagulation current will coagulate small capillaries easily Larger vessels can be picked up with hemostats which in turn may be touch
25. ndicate with an intermittent tone when the R F Power is present at the output Once contact is made with the electrode to the tissue and a small current is flowing the tone will become steady The ideal power setting 1s the minimum settings where cutting and coagulating meet the criteria described on pages 13 and 14 If the power is too high the tissue will be discolored and there will be considerable sparking when the electrode contacts the surface If the power is too low the electrode will drag through the tissue tearing and burning instead of cutting cleanly and will pick up shredded and torn tissue Power requirements will vary with the type and size of the electrode the area of electrode surface in contact with the tissue the nature of the tissue whether cutting or coagulating and the depth of the incision desired Larger electrodes deeper incisions and tough fibrotic tissue are some indications for higher power settings CAUTION Do not use fine needle electrodes at high settings as they may be severely damaged by such use When practicing with these electrodes work up gradually from a low setting Generally you should not exceed a setting of 40 with fine needle electrodes CAUTION Do not use monitoring needle electrodes during electrosurgery If monitoring electrode cables are used the monitoring electrode cables should be placed as far away from electrosurgical cables AS POSSIBLE If it is absolutely necessary to cross over
26. nsuccessful When using electronically generated current it 1s safe to hold the hemostat in a gloved hand while holding the electrode handle in the other during this procedure ANESTHESIA Adequate anesthesia is indicated for all electrosurgical procedures It is usually advisable to anesthetize tissue adjacent to the intended operative site in the event it becomes necessary to extend the operative area BIOPSY The use of electrosurgery for cervical biopsy has advantages that electrosurgery seals the capillaries and lymphatics as it cuts The specimen should whenever possible include two to three millimeters of attached normal tissue Small up to one half inch masses should be removed in one piece Using cutting current at a relatively high setting and a needle electrode incise all around the mass in an elliptical pattern including two to three millimeters of attached normal tissue Small masses may also be removed by using a suitable loop electrode large enough so that it can excise the mass itself as well as two to three millimeters of attached normal tissue at the same time Specimens from larger masses should be taken in the form of pie shaped wedges Using a needle electrode and cutting current start at the apex of the wedge at the center of the suspicious mass The base of the wedge should include two to three millimeters of attached normal tissue 37962 Rev A 9 13 Wallach Surgical Devices l4 THE WALLACH RETURN EL
27. pecifically for your office With care it will give you years of trouble free service Read this manual carefully and follow the recommended program of practice An understanding of its contents will help you get the maximum benefit from the use of your electrosurgical system The manual covers applications and techniques for use as well as set up and maintenance of your system If you have any questions or problems call your local Wallach Representative or write to Customer Service Department 95 Corporate Drive Trumbull CT 06611 USA Phone 800 243 2463 203 799 2000 Fax 203 799 2002 customerservice wallachsurgical com www wallachsurgical com 37962 Rev A 9 13 Wallach Surgical Devices WARNINGS A THIS DEVICE IS A BF TYPE DEVICE TYPE BF EQUIPMENT IS A TYPE B EQUIPMENT WITH AN F TYPE APPLIED PART Type B is a piece of equipment providing a particular degree of protection against electric shock particularly regarding Allowable leakage current Reliability of the protective earth connection F Type isolated applied part Applied part isolated from all other parts of the equipment to such a degree that the patient leakage current allowable in single fault condition is not exceeded when a voltage equal to 1 1 times the highest rated mains voltage is applied between the applied part and earth B AVOIDING UNINTENTIONAL PATIENT BURNS 1 Do not activate electrode until all components are in place 2 Be cer
28. r than the MAXIMUM OUTPUT VOLTAGE gt ASSOCIATED EQUIPMENT and ACTIVE accessories should be selected with RATED ACCESSORY VOLTAGE gt MAXIMUM OUTPUT VOLTAGE when the smaller of variable y see below or the number 6 is lt CREST FACTOR for that HF SURGICAL MODE gt When MAXIMUM OUTPUT VOLTAGE Umax is gt 1 600 V and the CREST FACTOR is lt the variable y calculated below indicating that any ASSOCIATED EQUIPMENT and ACTIVE ACCESSORIES used with such mode or setting must be rated to withstand the combination of actual voltage and CREST FACTOR Umax 400 Volts 600 Volts 37962 Rev A 9 13 Wallach Surgical Devices INDICATIONS FOR USE OB GYN APPLICATIONS e The LEEP LLETZ procedure 1s indicated in the diagnosis and treatment of some Cervical Intraepithelial Neoplasia CIN in patients where there 1s e Cytological or colposcopic suspicion of CIN 2 or worse including micro invasion e Persistent CIN 1 of more than 12 months duration e CINI where the likelihood of follow up 1s low or when the patient requests treatment e A suspicion cytological or colposcopic of a glandular intraepithelial abnormality e A disparity between the cytological and colposcopic diagnoses e External anogenital lesion e Large vaginal intraepithelial neoplastic VAIN lesions e Cervical conization indications CONTRAINDICATIONS FOR OB GYN APPLICATIONS e The following are typical contraindications for performing the LEEP LLETZ procedur
29. re the electrodes are securely seated and firmly held in the handpiece so that the entire electrode shank 1s covered In general straight wire electrodes are used for incisions and for removing fine tissue Loops are used for removing heavier tissue planing and contouring Ball electrodes are used for coagulation Keep the electrode clean while operating Tissue shreds and debris on the electrode reduce the effectiveness of the current and by impeding the passage of the electrode through the tissue slows down the stroke This creates unnecessarily heavy coagulation which can cause sloughing and delay healing Inspect the electrodes for proper insulation BIOVAC SMOKE EVACUATOR OPERATION AUTOMATIC MODE OPTION The Biovac Smoke Evacuator is set up to operate automatically from the Quantum 2000 This 1s accomplished by means of a special IR LED Infra Red Light Emitting Diode in the Integration Unit which is mounted on the rear panel of the Quantum 2000 When the R F Output is activated by the operator the rear panel LED produces an output which 1s received by the interface module of the Biovac interface assembly The motor will come ON and stay ON for five 5 seconds after the energized output 1s terminated PURGE BUTTON The Biovac may also be tested or used without the Quantum 2000 output by pressing the Purge button on the front panel The motor will stay on for five 5 seconds after the button 1s released Most
30. se covering any failure of the device due to defective workmanship or components when used in compliance with the product s intended use Only Wallach is authorized to service or repair this unit Do not disassemble the device There are no user serviceable components within the housing SERVICE REPAIR Wallach equipment is built to give maximum trouble free service The need for service under normal operating conditions 1s almost non existent Almost without exception the cause of poor performance by the machine will prove to be defective cords and or connections Check all cords and all connections periodically for signs of loose wires worn insulation or loose fit On all models check the connection from cords to console Broken wires and connections can be detected by the use of a continuity meter Only Wallach is authorized to service or repair this unit If repair is attempted outside the factory the warranty will be considered void Wallach is not responsible for any injury resulting from repairs made by other individuals or organizations not certified by Wallach If a repair is needed carefully package the Quantum 2000 in a protective carton Return carton to WALLACH 95 Corporate Drive Trumbull CT 06611 USA Phone 800 243 2463 203 799 2000 Fax 203 799 2002 customerservice wallachsurgical com www wallachsurgical com Products should be securely packaged in the original carton Equipment must be sanitized before
31. tain to have an unobstructed path and view 3 Use only non conductive ancillary instruments 4 Remove patient jewelry metal drape clips etc and needles 5 A patient return electrode pad must be used The entire area of the grounding pad should be reliability attached to the patient s body and as close to the operating field as possible 6 Place footswitch in safe position out of traffic 7 Turn console OFF or place in WAIT state when not in use 8 Do not use unit on small appendages due to current density Bipolar techniques may be desirable for use on small appendages C THERMAL INJURY AND DEFECTS OF TISSUE TREATED WITH LOOP ELECTRODES Possible injury to cervical tissue may include 1 thermal coagulation injury of the cervix up to one third the thickness of normal epithelium of the cervix 2 fragmentation of squamous epithelium of the cervix attributable to long exposure periods along the excision site that allows heat to dissipate laterally and 3 partial coagulation of the endocervical epithelium because of lateral radiation of heat Loop electrosurgical excision procedures may also produce thermal defects at the periphery of the excised tissue and may make histopathologic interpretation difficult or impossible and may prevent accurate diagnosis and the evaluation of the need for further treatment D FLAMMABLE GASES SOLUTIONS e When using a flammable preparatory solution such as alcohol be certain that t
32. tivated Self monitoring of all detectors CLASSIFICATION Model Safety Class Type Q2000 Electrosurgical Units I BF Do not get fluid into the Q2000 Electrosurgical Units Should any liquid or solid object fall into the unit unplug the unit and call Technical Support The Q2000 Electrosurgical Units are suitable for intermittent operation with a 2 minute ON and 6 minute OFF duty cycle The Q2000 Electrosurgical Units are classified as normal equipment IPX0 according to protection against ingress of water ENVIRONMENT CONDITIONS Use Environmental Temperature between 10 C and 40 C Relative Humidity between 10 and 90 Shipping and Storage Environmental Temperature between 10 C and 40 C Relative Humidity between 10 and 90 37962 Rev A 9 13 Wallach Surgical Devices 21 POWER OUTPUT CHARACTERISTICS Cut mode 500 Ohms 200 Ohms 1000 Ohms 100 Ohms 50 Ohms 2000 Ohms Output Watts 25 50 75 Power Setting Blend mode 500 Ohms 200 Ohms 100 Ohms 50 Ohms 1000 Ohms 2000 Ohms wi E m nm z O 50 J5 Power Setting Coag mode 500 Ohms 1000 Ohms 200 Ohms 2000 Ohms 100 Ohms Output Watts 50 Ohms 25 50 75 Power Setting 37962 Rev A 9 13 Wallach Surgical Devices DI POWER OUTPUT AT VARIOUS LOAD RESISTANCE Output Watts ut E m sa z amp O Output Watts 37962 Rev A 9 13 Cut mode 100 Full 500 1000 1500 2000 Load Ohms Bl
33. tive 2 Replace No power when 3 Pencil defective 3 Replace footswitch 1s depressed No power when switch on handpiece Is depressed F m Unit not connected m Plug into wall outlet Digital readout 2 Digital readout 2 Return to Wallach does not illuminate circuitry failure G 1 Stuck panel switch 1 Turn unit off System beeps long 2 Stuck foot switch press each switch and make sure intervals 3 Stuck hand switch they depress freely button 4 A footswitch or handswitch 1s active upon power up 37962 Rev A 9 13 Wallach Surgical Devices 18 SPECIFICATIONS FOR QUANTUM 2000 SIZE 4 25 H 9 38 W 11 63 D Weight 10 Ibs 9 oz 10 8 cm 23 8 cm 29 5 cm 5 25 kg ELECTRICAL Input Voltage 120 VAC 220 VAC Maximum Current 3 15 Amps 1 55 Amps VA Ratings 132 VA 242 VA Power Line Leakage Less than 50 micro amps Less than 50 micro amps Fuses 5 x 20 mm Two T 3 15A 250V Two TT 2 5A 250 V Slow Blow Super Slow Blow Littelfuse 02183 15 Bussmann GMD 2 5A or Equivalent or Equivalent HIGH FREQUENCY OUTPUT Rated output power 1s 100 watts 495 KHz 5 into 500 ohms monopolar only MINIMUM amp MAXIMUM CREST MAXIMUM OPEN POWER SETTINGS FACTOR CIRCUIT VOLTAGE 10 to 100 watts 10 to 100 watts 10 to 100 watts Accuracy of output control setting For output powers in excess of 10 Watts the actual power as a function of the load resistance and output control setting shall not deviat
34. twork that supplies buildings used for domestic purposes Harmonic emissions PY IEC 61000 3 2 Voltage fluctuations Flicker emissions Complies IEC 61000 3 3 37962 Rev A 9 13 Wallach Surgical Devices 25 GUIDANCE AND MANUFACTURER S DECLARATION ELECTROMAGNETIC IMMUNITY The Wallach Electrosurgical Generators are intended for use in the electromagnet environment specified below The customer or the end user of the Wallach Electrosurgical Generators should assure that it 1s used in such an environment Immunity Test Electromagnetic discharge ESD IEC 61000 4 2 Electrical fast transient burst IEC 61000 4 4 Surge IEC 61000 4 5 Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 Power frequency 50 60 Hz magnetic field IEC 61000 4 8 IEC 60601 Level Test 6 kV contact 8 kV air 2 kV for power supply lines 1 kV for input output lines 1 kV differential mode 2 kV common mode 5 Ur gt 95 dip in Ur for 0 5 cycle 40 Ur 60 dip in Ur for 5 cycles 70 Ur 30 96 dip in Ur for 25 cycles 5 Ur gt 95 dip in Ur for 5 sec Compliance Level 6 kV contact 8 kV air 2 kV for power supply lines kV for input output lines 1 kV differential mode 2 kV common mode 5 Ur gt 95 dip in Ur for 0 5 cycle 40 Ur 60 dip in Ur for 5 cycles 70 Ur 30 dip
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