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Surgistat II coagulation Users Manual

1. Power adjustment during activation You can change the power setting while you activate the unit If you change the power setting for the mode you are using your change affects the power you are applying to the patient You can increase or decrease power as much as three watts per second while activating the unit Isolated RF output This minimizes the potential of alternate site burns Standard connectors These connectors accept the latest monopolar and bipolar instruments Self diagnostics These diagnostics continually monitor the unit to ensure proper performance Valleylab electrosurgical generators patient return electrodes and active accessories are designed to work as a system Valleylab offers a selection of patient return electrodes and electrosurgical instruments that are fully compatible with this generator When considering other manufacturer s patient return electrodes and or active accessories customers should seek detailed user instructions and warning information from the manufacturer SurgiStat II 20 User s Guide Components and Accessories Components and Accessories Safety You should receive the following components e SurgiStat II electrosurgical generator Hospital grade power cord e User s guide e Service manual The following items are optional accessories that you can use with the SurgiStat II generator e E6008 Monopolar footswitch 4 6 m 15 ft cord e E6008B Monopolar footswitch 4
2. Kalleylab User s Guide SurgiStat Il 20 Electrosurgical Generator 0086 This manual and the equipment it describes are for use only by qualified medical professionals trained in the particular technique and surgical procedure to be performed It is intended as a guide for using the Valleylab SurgiStat II 20 electrosurgical generator only Additional technical information is available in the SurgiStat II Electrosurgical Generator Service Manual Federal USA laws restrict this device to sale by or on the order of a physician Equipment covered in this manual Surg I 20 electrosurgical generator Valleylab Part Number 1003623 Effective Date August 2006 Trademark acknowledgements Valleylab ForceTriad Force EX Force EZ Force Argon LigaSure LigaSmart Smart Cool Tip TissuFect REM RFG 3C OptiMumm SurgiStat EDGE AccuVac PolyHesive and Instant Response are trademarks of Valleylab Manufactured for Valleylab a division of Tyco Healthcare Group LP Boulder Colorado 80301 3299 USA For information call 1 303 530 2300 European representative Tyco Healthcare UK Ltd Gosport PO13 OAS UK Made in USA Printed in USA 2006 Valleylab All rights reserved SurgiStat Il 20 User s Guide Conventions Used in this Guide Indicates a potentially hazardous situation which if not avoided could result in death or serious injury Indicates a hazardous situ
3. SurgiStat II 20 User s Guide Performance Characteristics Operating Parameters Ambient temperature 10 to 40 C 50 to 104 F range Relative humidity 1596 to 7596 noncondensing Atmospheric pressure 700 to 1060 millibars Warm up time If transported or stored at temperatures outside the operating temperature range allow one hour for the generator to reach room temperature before use Transport and Storage Ambient temperature 34 to 65 C 29 to 149 F range Relative humidity 0 to 75 noncondensing Atmospheric pressure 500 to 1060 millibars Audio Volume The audio levels stated below are for activation tones Bipolar Cut and Coag and alarm tones return electrode and system alarms at a distance of one meter Alarm tones meet the requirements for IEC 60601 2 2 Activation Tone Volume adjustable 45 to 65 dBA Frequency Cut 1 kHz Blend 1 kHz Desiccation 2 kHz Fulguration 2 kHz Bipolar 2 kHz Duration Continuous while the generator is activated SurgiStat II 20 User s Guide suomneouioeds eoiuu29 Performance Characteristics Alarm Tone Volume not 70 dBA x 5 dBA adjustable Frequency 2 kHz for 1 second then 1 kHz for 1 second Duration 4 seconds Patient Return Electrode Sensing Single Plate Measurement current 100 pA Measurement frequency 62 5 kHz 2 5 kHz Set resistance 0 O to 5 O 30 Continuous measurement Once the system establishes the single plat
4. Connect the power cord to a properly polarized and grounded power source with the frequency and voltage characteristics that match those listed on the back of the unit Fire Hazard Do not use extension cords Patient Safety Use the generator only if the self test has been completed as described Otherwise inaccurate power outputs may result The instrument receptacles on this generator are designed to accept only one instrument at a time Do not attempt to connect more than one instrument at a time into a given receptacle Doing so will cause simultaneous activation of the instruments Failure of the high frequency electrosurgical equipment could result in an unintended increase of output power Do not use electrosurgical equipment unless properly trained to use it in the specific procedure being undertaken Use by physicians without such training has resulted in serious unintended patient injury including bowel perforation and irreversible tissue necrosis For surgical procedures where the high frequency current could flow through parts of the body having a relatively small cross sectional area the use of bipolar techniques may be desirable to avoid unwanted coagulation If the patient has an implantable cardioverter defibrillator ICD contact the ICD manufacturer for instructions before performing an electrosurgical procedure Electrosurgery may cause multiple activation of ICDs 4 2 SurgiStat Il 20 User s Guide Setup Saf
5. 6 m 15 ft cord e E8007 Compact mounting cart e E8002 Mounting stand The safe and effective use of electrosurgery depends to a large degree on factors solely under the control of the operator There is no substitute for a properly trained and vigilant medical staff It is important that they read understand and follow the operating instructions supplied with this electrosurgical equipment Physicians have used electrosurgical equipment safely in numerous procedures Before starting any surgical procedure the surgeon should be familiar with the medical literature complications and hazards of using electrosurgery in that procedure To promote the safe use of the SurgiStat II electrosurgical generator this section presents the warnings and cautions that appear throughout this user s guide So that you can operate this equipment with maximum safety it is important that you read understand and follow the instructions in these warnings and cautions It is also important that you read understand and follow the instructions for use in this user s guide SurgiStat II 20 User s Guide Jojejouas edDIBInsou0I F rexsiBans y Buronpoutul Safety Warnings Hazardous Electrical Output This equipment is for use only by trained licensed physicians Danger Fire Explosion Hazard Do not use the SurgiStat Il electrosurgical generator in the presence of flammable anesthetics Fire Explosion Hazard The following substa
6. for Occupational Safety and Health NIOSH Control of Smoke from Laser Electric Surgical Procedures HAZARD CONTROLS Publication No 96 128 September 1996 SurgiStat Il 20 User s Guide 4 7 Ye1si amp ung eui Bus Activating the Unit Activating the Unit During a surgical procedure the amount of current delivered during a given time period determines the amount of heating that occurs under the electrode AII Valleylab patient return electrodes are designed for use during traditional surgical procedures and duty cycles on time compared to off time Users should consult the Technical Specifications section of the generator user manual for the recommended maximum duty cycle specifications Itis not possible to foresee what combination of current and duty cycle may be safely used in every situation such as when higher currents and or longer duty cycles are used on procedures such as tissue lesioning tissue ablation tissue vaporization and procedures where conductive fluid is introduced into the surgical site Under these conditions there can be greater risk that the heating under a fully applied return electrode may be high enough to injure the patient When using a Valleylab generator or patient return electrode during these types of surgical procedures the user should seek written guidance from the manufacturer of the active accessory regarding the currents and duty cycles that can be expected as well as detailed user instru
7. handpiece or the cut or coag pedal on the footswitch F3 Monopolar handpiece activated while Release pressure on the handpiece buttons Use the in Bipolar mode footswitch to activate Bipolar or switch to Monopolar mode E4 Line voltage error Line voltage too 1 Turn the unit off high 2 Verify that the unit is connected to the correct line voltage 6 2 SurgiStat Il 20 User s Guide Correcting Malfunctions Error Code Description E5 Internal pulse width measurement exceeds setting requirements E6 Internal pulse width measurement conflicts with calibrated value E7 Internal temperature of the unit exceeded limit Recommended Action Turn unit off If using a metal patient return electrode plate verify that the cable connections are secure and replace cables with loose connections Turn unit on If error code occurred directly after changing mode of operation turn on the unit and delay activation of the accessories after changing mode of operation If alarm number reappears upon restarting the unit record the number and call the Valleylab Service Center Turn unit off If error code occurred directly after changing mode of operation turn on the unit and delay activation of the accessories after changing mode of operation If error code occurred directly after changing the power setting during activation turn on the unit and limit the change of power to approximately three watts per second If alarm n
8. lt 10 pA l all eads alloutputs Normal polarity ground open lt 50 pA Reverse polarity ground open 50 uA Sink current at high 50 LA line all inputs High Frequency RF Leakage Current Bipolar RF leakage lt 39 MA ims current Monopolar RF leakage lt 150 MA rms current additional tolerance Standards and IEC Classifications The SurgiStat II 20 generator meets all pertinent clauses of the IEC 60601 1 second edition and IEC 60601 2 2 third edition Class Equipment IEC 60601 1 Accessible conductive parts cannot become live in the event of a basic insulation failure because of the way in which they are connected to the protective earth conductor SurgiStat Il 20 User s Guide 8 5 suomneouioeds eDIUYIJBL Standards and IEC Classifications Type CF Equipment IEC 60601 1 Defibrillator Proof The SurgiStat II generator provides a high degree of protection against ie electric shock particularly regarding allowable leakage currents It is type CF isolated floating output and may be used for procedures involving the heart Liquid Spillage IEC 60601 2 2 Clause 44 3 The SurgiStat II 20 generator enclosure is constructed so that liquid spillage in normal use does not wet electrical insulation or other components which when wetted are likely to adversely affect the safety of the equipment Electromagnetic Interference When placed on or beneath an activated Valleylab electrosurgical gener
9. on by switching the power switch to the On l position Checking the Patient Return Electrode Alarm 1 Adjust the power settings for each mode Cut Blend Desiccate Fulgurate and Bipolar to one watt Press the Cut pedal of the footswitch Verify that an alarm sounds for three seconds and the Patient Return Electrode Sensing Alarm Indicator Light illuminates indicating that you have not connected a patient return electrode to the unit Verify that adjusting the volume control on the back of the unit while the alarm is sounding cannot change the alarm sound level Confirming Modes Confirm that you can select each mode and adjust power up and down Checking Bipolar Mode with Footswitch 1 Select Bipolar mode by pressing the Bipolar Mode Selector Note The unit automatically changes to bipolar footswitching when the bipolar mode is selected Verify that the Bipolar Mode Indicator illuminates and that the system generates the Coag tone when you press the Coag pedal Blue or the Cut pedal Yellow on the footswitch While activating the Bipolar mode rotate the volume control over the full range to verify that the sound is audible throughout the range Confirm that releasing the Coag pedal or the Cut pedal returns the unit to an idle state Checking Monopolar Mode with Footswitch 1 Select monopolar foot control by pressing the Footswitch Control Selector until the Monopolar Footswitch Cont
10. wall outlet N Thoroughly wipe all surfaces of the generator and power cord with a mild cleaning solution or disinfectant and a damp cloth Follow the procedures approved by your institution or use a validated infection control procedure Every six months visually inspect the SurgiStat II for signs of wear or damage In particular look for any of the following problems Damage to the power cord Damage to the power cable receptacle e Obvious damage to the unit Damage to any receptacle e Accumulation of lint or debris in or around the unit SurgiStat Il 20 User s Guide Fuse Replacement Fuse Replacement Fuses for the unit reside directly below the Power Cable Receptacle on the rear of the unit To replace the fuses follow this procedure 1 2 3 5 Unplug the power cord from the wall outlet Remove the power cord from the Power Cable Receptacle on the rear panel To release the fuse drawer insert a small flathead screwdriver into the slot on the drawer below the power cord receptacle and slide the drawer out Fuse Remove the two fuses and Drawer replace them with new fuses with the same values Insert the fuse drawer into the Power Cable Receptacle Use the following fuses Surg Il 20 110 120 V VAC 250 Amps 5 0 A Type Slow Blow Size 5 x 20 mm SurgiStat II 20 User s Guide I rejsi6uns eui Guiureyuren Kalleylab 5 4 SurgiStat II 20 User s Guide T
11. Monopolar Footswitching Receptacle Accepts cables or adapters equipped with standard Bovie 12 active plugs Connect footswitching accessories 2 6 SurgiStat Il 20 User s Guide Hear Panel Rear Panel Figure 2 6 Layout of connectors and controls on the rear panel Equipotential Connector Allows attaching a standard grounding cable to chassis ground for additional protection against leakage current Volume Control Controls the volume of the audible tones produced during normal unit activation To increase volume rotate the knob clockwise MONOPOLAR TZIL f b A Falleylab SurgiStat Il SN WARNING RISK OF FIRE PAS MARKED 0086 250V 75 0A 110 120 Se A Ji Footswitch Receptacle Serial Number Label Power Cable Receptacle and Fuse Accepts the E6008 or E6008B Specifies the unit model Holder monopolar footswitch Use the number serial number Connects a hospital grade power monopolar footswitch for both nominal line voltage cord to supply AC mains power to monopolar and bipolar frequency current and the unit activation Use only a Valleylab power consumption monopolar footswitch with the SurgiStat Il 20 generator Use of an incompatible footswitch may cause unexpected output SurgiStat II 20 User s Guide 2 7 Sa oe1dodoy pue SIO BeIIPLU SJO11U0J Symbols on the Front Panel Sym
12. Power Curves Figure 8 9 Output power vs generator settings for Desiccate mode Figure 8 10 Output power vs impedance for Fulgurate mode Output Power watts Output Power watts 80 0 5 10 15 20 25 30 35 40 45 50 55 60 65 70 75 80 Generator Setting 50 45 t t t t t 1 500 1000 1500 2000 2500 3000 Load Resistance ohms 8 12 SurgiStat Il 20 User s Guide Output Power Curves Figure 8 11 Peak voltage vs power setting for Fulgurate mode Figure 8 12 Output power vs generator settings for Fulgurate mode Open Circuit Peak Voltage volts Output Power watts 5000 4500 4000 3500 3000 2500 2000 1500 1000 500 40 35 30 25 4 20 15 4 10 Output Power Setting watts 10 15 20 25 30 35 40 Generator Setting SurgiStat II 20 User s Guide 8 13 suomneouioeds eoiuu29 Output Power Curves Bipolar Curves Figure 8 13 Output power vs impedance for Bipolar mode SO 451 401 T E oO 35 2 D o a 5 o 5 O 0 500 1000 1500 200n 2500 2000 Load Resistance ohms Figure 8 14 Peak voltage vs power setting for Bipolar mode m 1200 2 1000 amp 800 S 600 x 400 a 5 200 2 o 0 5 1 5 10 15 20 25 30 o E Output Power Setting watts 8 14 SurgiStat Il 20 User s Guide Output Power Curves Figure 8 15 Output power vs generator settings for Bipolar
13. User s Guide Chapter 5 Maintaining the SurgiStat Il Cleaning 5 2 Periodic Inspection 5 2 Fuse Replacement 5 3 Chapter 6 Troubleshooting General Troubleshooting Guidelines 6 2 Correcting Malfunctions 6 2 Chapter 7 Repair Policy and Procedures Responsibility of the Manufacturer 7 2 Returning the Generator for Service 7 2 Obtain a Return Authorization Number 7 2 Clean the Generator 7 3 Ship the Generator 7 3 Chapter 8 Technical Specifications Performance Characteristics 8 2 Input Power 8 2 Duty Cycle 8 2 Dimensions and Weight 8 2 Operating Parameters 8 3 Transport and Storage 8 3 Audio Volume 8 3 Patient Return Electrode Sensing 8 4 Low Frequency 50 60 Hz Leakage Current 8 5 High Frequency RF Leakage Current 8 5 Standards and IEC Classifications 8 5 Class Equipment IEC 60601 1 8 5 Type CF Equipment IEC 60601 1 Defibrillator Proof 8 6 Liquid Spillage IEC 60601 2 2 Clause 44 3 8 6 Electromagnetic Interference 8 6 Voltage Transients Emergency Generator Mains Transfer 8 6 Electromagnetic Compatibility IEC 60601 1 2 and IEC 60601 2 2 8 6 Output Characteristics 8 7 Maximum Output for Bipolar and Monopolar Modes 8 7 Output Power Curves 8 8 Monopolar Cut Curves 8 8 Monopolar Coag Curves 8 11 Bipolar Curves 8 14 Chapter 9 Warranty SurgiStat II 20 User s Guide List of Figures Figure 2 1 Figure 2 2 Figure 2 3 Figure 2 4 Figure 2 5 Figure 2 6 Figure 8 1 Figu
14. al generator and other electronic equipment such as monitors An activated electrosurgical generator may cause interference with them Nonfunction of the generator may cause interruption of surgery A backup generator should be available for use Do not turn the activation tone down to an inaudible level The activation tone alerts the surgical team when an accessory is active When using a smoke evacuator in conjunction with the electrosurgical generator place the smoke evacuator a distance from the generator and set the generator volume control at a level that ensures that the activation tones can be heard Notice If required by local codes connect the generator to the hospital equalization connector with an equipotential cable Connect the power cord to a wall outlet having the correct voltage Otherwise product damage may result SurgiStat II 20 User s Guide 4 3 Ye1si amp ung eui usn Setting Up Setting Up Verify that the generator is off by pressing the power switch Off O Place the generator on a stable flat surface such as a table platform or Valleylab cart Carts with conductive wheels are recommended For details refer to the procedures for your institution or to local codes Provide at least 10 to 15 cm 4 to 6 in of space from the sides and top of the generator for cooling Normally the top sides and rear panel are warm when you use the generator continuously for extended period
15. are used simultaneously on the same patient place any monitoring electrodes as far as possible from the surgical electrodes Do not use needles as monitoring electrodes during electrosurgical procedures Inadvertent electrosurgical burns may result To avoid the possibility of an electrosurgical burn to either the patient or the physician do not allow the patient to come in contact with a grounded metal object during activation When activating the unit do not allow direct skin contact between the patient and the physician Remove any loose fitting jewelry from the patient before activation 1 6 SurgiStat II 20 User s Guide Safety Examine all accessories and connections to the electrosurgical generator before use Ensure that the accessories function as intended Improper connection may result in arcs sparks accessory malfunction or unintended surgical effects When not using active accessories place them in a holster or in a clean dry nonconductive and highly visible area not in contact with the patient Inadvertent contact with the patient may result in burns Studies have shown that smoke generated during electrosurgical procedures can be potentially harmful to patients and the surgical team These studies recommend adequately ventilating the smoke by using a surgical smoke evacuator or other means Notice If required by local codes connect the generator to the hospital equalization connector with an equipo
16. ation which if not avoided may result in minor or moderate injury gt important Indicates an operating tip or i Notice maintenance suggestion Indicates a hazard which may result in product damage SurgiStat Il 20 User s Guide iii Table of Contents Conventions Used in this Guide iii List of Figures vii Chapter 1 Introducing the SurgiStat Il Electrosurgical Generator Key Features 1 2 Components and Accessories 1 3 Safety 1 3 Warnings 1 4 Cautions 1 6 Chapter 2 Controls Indicators and Receptacles Front Panel 2 2 Cut and Blend Controls 2 3 Coag and Bipolar Controls 2 4 Indicators 2 5 Power Switch and Receptacles 2 6 Rear Panel 2 7 Symbols on the Front Panel 2 8 Symbols on the Rear Panel 2 9 Chapter 3 Getting Started Initial Inspection 3 2 Installation 3 2 Function Checks 3 2 Setting Up the Unit 3 2 Checking the Patient Return Electrode Alarm 3 3 Confirming Modes 3 3 Checking Bipolar Mode with Footswitch 3 3 Checking Monopolar Mode with Footswitch 3 3 Checking Monopolar Mode with Handswitch 3 4 Performance Checks 3 4 Chapter 4 Using the SurgiStat Il Inspecting the Generator and Accessories 4 2 Setup Safety 4 2 Setting Up 4 4 Preparing for Monopolar Surgery 4 4 Applying the Patient Return Electrode 4 4 Connecting Accessories 4 5 Preparing for Bipolar Surgery 4 5 Activation Safety 4 6 Activating the Unit 4 8 iv SurgiStat Il 20
17. ator the SurgiStat II generator operates without interference The generator minimizes electromagnetic interference to video equipment used in the operating room Voltage Transients Emergency Generator Mains Transfer The SurgiStat II generator operates in a safe manner when the transfer is made between line AC and an emergency generator voltage source Electromagnetic Compatibility IEC 60601 1 2 and IEC 60601 2 2 The SurgiStat II generator complies with the appropriate IEC 60601 1 2 and IEC 60601 2 2 specifications regarding electromagnetic compatibility Notice The SurgiStat Il requires special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the SurgiStat II Service Manual Portable and mobile RF communications equipment can affect the SurgiStat II Refer to the EMC information provided in the SurgiStat II Service Manual 8 6 SurgiStat Il 20 User s Guide Output Characteristics Output Characteristics Maximum Output for Bipolar and Monopolar Modes Power readouts agree with actual power into rated load to within 20 or 5 watts whichever is greater All measurements were taken at the nominal input power voltage used for calibration Crest Factor Mode Output Power Output Repetition Rate Vp p max Rated Load Frequency Cut 120 W 5002 357 kHz 50 N A 2 5 kV 2 9 2096 kHz Blend 90 W 800 2 357 kHz 50 30 kHz 5 kHz 3 5
18. bols on the Front Panel Symbols Description Indicators Single plate patient return electrode Split plate patient return electrode Monopolar footswitch control Footswitch on the selector button Bipolar footswitch control J resp Power Switch and Handpiece Connectors Read instructions before use Type CF equipment RF isolated patient connections are isolated from earth at high frequency Caution high voltage gt ep 2 8 SurgiStat Il 20 User s Guide Symbols on the Rear Panel Symbols on the Rear Panel Symbols Description Equipotential ground stud Nonionizing radiation gt Volume control 4 AD Danger SS Explosion risk if used with flammable anesthetics Monopolar footswitch zz zi Read instructions before use SurgiStat II 20 User s Guide 2 9 Sa oe1dodoy pue SIO BDIPLU SJO11U0J Kalleylab 2 10 SurgiStat II 20 User s Guide Getting Started This section includes the following information Initial inspection Installing the unit Checking unit functions Testing unit performance SurgiStat Il 20 User s Guide 3 1 Initial Inspection Initial Inspection Installation Function Checks When you first unpack your SurgiStat II generator inspect it visually Look for any signs of damage e Verify that the shipping package contains all items listed on the packing list If the unit or an
19. ch control Bipolar Footswitch Control Indicator and Symbol llluminates when bipolar foot control is selected Patient Return Electrode Alarm Indicator Illuminates when the system detects a patient return electrode alarm condition O ab ch Oke POWER PATIENT ALARM Power Indicator Illuminates when the Monopolar Footswitch unit is on Control Indicator and Symbol Illuminates when monopolar foot Footswitch Control control is selected Selector When pressed switches between monopolar and bipolar foot control Split Plate Patient Return Electrode Indicator Illuminates when the system detects a split plate Single Plate Patient Return Electrode Indicator Illuminates when the system detects a single plate SurgiStat II 20 User s Guide 2 5 Sa oe1dodoy pue SIO BeIIPLU SJO11U0J Power Switch and Receptacles Power Switch and Receptacles Figure 2 5 Location of the unit power switch and front panel receptacles ma um n C cur coac J nace O Bo mw m EI Valleylab b POWER PATIENT Power On Off Switch Turns the unit on or off Patient Return Electrode Receptacle Accepts a standard patient return Bipolar Receptacle Accepts standard cables for Bipolar handpieces MONOPOLAR BIPOLAR Monopolar Handswitching Receptacle Accepts standard three pin handpieces Connect handswitching accessories electrode plug
20. ctions In some instances the application of additional patient return electrodes may help mitigate the increased risk When you turn on your unit remember these features e SurgiStat II will power up to the most recently used modes and most recently used settings For example if you set Pure Cut mode at 50 watts when you turned the unit off it will automatically return to Pure Cut mode at 50 watts when you turn it on again Similarly if you set Desiccate mode at 40 watts before you turned the unit off it will return to Desiccate mode at 40 watts when you turn it on again e When you switch from Pure Cut mode to Blend or the reverse the unit maintains its power setting Also when you switch among Desiccate Fulgurate and Bipolar the unit maintains its power setting For example if you are working in Pure Cut at 75 watts and you switch to Blend the unit maintains a power setting of 75 watts EXCEPTION If you are working in Pure Cut mode at 110 watts and switch to Blend mode the unit automatically reduces its power setting to the maximum setting for Blend mode 90 watts Similarly if you are working in Desiccate mode at 25 watts and switch to Fulgurate or Bipolar the unit maintains 25 watts EXCEPTION If you are working in Desiccate mode at a power setting of 80 watts and switch to Fulgurate mode the unit automatically reduces its power setting to the maximum for Fulgurate 40 watts If you switch to Bipolar the unit auto
21. due to a reduction in patient contact area during monopolar electrosurgery Using a patient return electrode without the RECQMS safety feature may result in a patient burn SurgiStat Il 20 User s Guide Preparing for Bipolar Surgery 1 Apply the patient return electrode to the patient Refer to the manufacturer s instructions for application site and placement procedures When using metal plate patient return electrodes use a conductive gel specifically designed for electrosurgery Select a patient return electrode site with good blood flow While a properly applied electrode results in minimal tissue heating beneath the electrode a good blood flow helps carry heat away from the site gt Important The RECQMS system requires 2 Connect the cable to the Patient Return Electrode Receptacle on the front of that you use a split plate patient the unit return electrode UEM 3 After a delay of approximately three seconds the unit will sense the presence of a single or split plate patient return electrode The unit will then constantly monitor the resistance of the single plate electrode or the resistance at the contact between the split plate electrode and the patient Connecting Accessories 1 Connect a monopolar active electrode to the unit If you are using Connect it to Standard 3 pin handswitching Monopolar Handswitching Receptacle pencil Footswitching pencil Monopolar Footswitching Receptacle 2 If u
22. e electrode resistance an increase of 20 Q 5 Q in resistance will cause an alarm When the alarm condition exists the system deactivates output power Split Plate Measurement current 100 pA Measurement frequency 62 5 kHz 2 5 kHz Set resistance 10 Q 5 Q to 135 O 10 0 Continuous measurement Once the system establishes the split plate electrode resistance an increase of 4096 in resistance or up to 150 whichever is less will cause an alarm A decrease of resistance below 4 Q 2 O will cause an alarm When the alarm condition exists the system deactivates output power The system presents audible and visible alarms when it does not sense a patient return electrode e When a fault condition occurs the alarm indicator flashes red an alarm tone sounds and the system disables output power e The red LED alarm indicator remains illuminated until the condition that caused the alarm is corrected e Activation attempts during an alarm condition result in an audio alarm and the alarm indicator flashes 8 4 SurgiStat II 20 User s Guide Standards and IEC Classifications e When the alarm condition is resolved the green single or split plate indicator will illuminate e The system measures the return electrode sensing current according to IEC 60601 1 Low Frequency 50 60 Hz Leakage Current Enclosure source lt 300 HA current ground open Source current patient Normal polarity intact ground
23. ety In some circumstances the potential exists for alternate site burns at points of skin contact e g between the arm and the side of the body This occurs when electrosurgical current seeks a path to the patient return electrode that includes the skin to skin contact point Current passing through small skin to skin contact points is concentrated and may cause a burn This is true for grounded ground referenced and isolated output generators To reduce the potential for alternate site burns do one or more of the following Avoid skin to skin contact points such as fingers touching leg when positioning the patient Place 5 to 8 cm 2 to 3 in of dry gauze between contact points to ensure that contact does not occur Position the patient return electrode to provide a direct current route between the surgical site and the return electrode that avoids skin to skin contact areas n addition place patient return electrodes according to the manufacturer s instructions Potential for alternate site burns increases if the return electrode is compromised Valleylab recommends the use of split plate patient return electrodes and Valleylab generators with a contact quality monitoring system Do not stack equipment on top of the generator or place the generator on top of electrical equipment These configurations are unstable and or do not allow adequate cooling Provide as much distance as possible between the electrosurgic
24. g so will cause simultaneous activation of the instruments Use the lowest output setting necessary to achieve the desired surgical effect Use the active electrode only for the minimum time necessary in order to reduce the possibility of unintended burn injury Pediatric applications and or procedures performed on small anatomic structures may require reduced power settings The higher the current flow and the longer the current is applied the greater the possibility of unintended thermal damage to tissue especially during use on small structures 1 4 SurgiStat Il 20 User s Guide Safety Use electrosurgery with caution in the presence of internal or external pacemakers Interference produced by the use of electrosurgical devices can cause a pacemaker to enter an asynchronous mode or can block the pacemaker effect entirely Consult the pacemaker manufacturer or hospital Cardiology Department for further information when use of electrosurgical appliances is planned for patients with cardiac pacemakers If the patient has an implantable cardioverter defibrillator ICD contact the ICD manufacturer for instructions before performing an electrosurgical procedure Electrosurgery may cause multiple activation of ICDs Do not use electrosurgical equipment unless properly trained to use it in the specific procedure being undertaken Use by physicians without such training has resulted in serious unintended patient injury including bowel pe
25. gen enriched atmospheres Oxidizing agents such as nitrous oxide N20 atmospheres The sparking and heating associated with electrosurgery can provide an ignition source Observe fire precautions at all times When using electrosurgery in the same room with any of these substances or gases prevent their accumulation or pooling under surgical drapes or within the area where electrosurgery is performed Use the lowest output setting necessary to achieve the desired surgical effect Use the active electrode only for the minimum time necessary in order to lessen the possibility of unintended burn injury Pediatric applications and or procedures performed on small anatomic structures may require reduced power settings The higher the current flow and the longer the current is applied the greater the possibility of unintended thermal damage to tissue especially during use on small structures Use electrosurgery with caution in the presence of internal or external pacemakers Interference produced by the use of electrosurgical devices can cause a pacemaker to enter an asynchronous mode or can block the pacemaker effect entirely Consult the pacemaker manufacturer or hospital Cardiology Department for further information when use of electrosurgical appliances is planned for patients with cardiac pacemakers 4 6 SurgiStat Il 20 User s Guide Activation Safety The use of high frequency current can interfere with the function of other elec
26. his section includes the following information Key features Components and accessories Safety Read all warnings cautions and instructions provided with this generator before using Read the instructions warnings and cautions provided with electrosurgical accessories before using Specific instructions are not included in this manual SurgiStat II 20 User s Guide 14 Key Features Key Features Important The RECQMS system requires that you use a split plate patient return electrode The SurgiStat II electrosurgical generator includes the latest technology This unit offers unsurpassed performance flexibility reliability and convenience It includes the following features Two levels of coagulation desiccation and fulguration Desiccation provides precise control of bleeding in localized areas Fulguration provides greater control of bleeding in highly vascular tissue over broad surface areas Return electrode sensing and contact quality monitoring The SurgiStat II incorporates a return electrode contact quality monitoring system RECQMS This system determines the type of patient return electrode single or split plate The system also continually monitors the contact quality between the patient and the split plate return electrode This feature is designed to eliminate patient burns at the return electrode site Memory The unit automatically powers up to the most recently used modes and power settings
27. ion and Bipolar Power Control Dial Activate the generator by pressing the appropriate button To activate press this on this device Monopolar Cut or Blend modes yellow button handswitching yellow pedal pencil footswitch Desiccate or blue button handswitching Fulgurate modes blue pedal pencil footswitch Bipolar Any Bipolar yellow Cut or blue footswitch Coag pedal SurgiStat Il 20 User s Guide 4 9 Ye1si amp ung eui Busy Kalleylab 4 10 SurgiStat II 20 User s Guide Maintaining the SurgiStat Il This section covers the following topics Cleaning Periodic inspection Fuse replacement SurgiStat Il 20 User s Guide 5 1 Cleaning Cleaning Periodic Inspection Valleylab recommends that you complete periodic inspection and performance testing Perform inspections and performance testing every six months A qualified biomedical technician should conduct this testing to ensure that the unit is operating effectively and safely After each use clean the unit Electric Shock Hazard Always turn off and unplug the generator before cleaning Do not allow fluids to enter the generator chassis Do not sterilize the generator Notice Do not clean the generator with abrasive cleaning or disinfectant compounds solvents or other materials that could scratch the panels or damage the generator Turn off the generator and unplug the power cord from the
28. kV 3 3 2096 kHz Desiccate 80 W 1000 Q 475 kHz 50 57 kHz 5 kHz 4 5 kV 5 5 2096 kHz Fulgurate 40 W 9 1000 410 kHz 50 25 kHz 5 kHz 6 5 kV 7 7 2096 kHz Bipolar 30 W 200 Q 520 kHz 50 32 kHz 5 kHz 2 0 kV 6 9 20 kHz effect An indication of a waveform s ability to coagulate bleeders without a cutting SurgiStat II 20 User s Guide suoneoyioeds eDIUYIJBL Output Power Curves Output Power Curves The curves that follow depict the changes for each mode at specific power settings All measurements were taken at the nominal input power voltage used for calibration Monopolar Cut Curves These measurements were taken using short 0 5 meter leads For each output power vs impedance curve the upper curve represents readings taken at full power the lower curve readings taken at half power Figure 8 1 Output power vs impedance for Pure Cut mode 1757 75 50 Output Power watis 25 Figure 8 2 Peak voltage vs power setting for Pure Cut mode 1800 1600 1400 1200 1000 800 600 400 200 0 Open Circuit Peak Voltage volts 1257 1007 500 1000 1500 2000 2500 3000 Load Resistance ohms ADAN an am AA f d 1 5 10 15 20 25 30 35 40 45 50 55 60 65 70 75 80 85 90 95 100 105 110 115 120 Output Power Setting watts 8 8 SurgiStat Il 20 User s Guide Output Power Curves Figure 8 3 Output p
29. l modes of operation for proper function and power output For a detailed description of performance testing procedures refer to the SurgiStat II Electrosurgical Generator Service Manual SurgiStat II 20 User s Guide Using the SurgiStat Il This section contains the following procedures Inspecting the generator and accessories Setup safety Setting up Preparing for monopolar surgery Preparing for bipolar surgery Activation safety Activating the unit Read all warnings cautions and instructions provided with this generator before use Read the instructions warnings and cautions provided with electrosurgical accessories before use Specific instructions are not included in this manual SurgiStat Il 20 User s Guide 4 1 Inspecting the Generator and Accessories Inspecting the Generator and Accessories Before each use of the SurgiStat IL verify that the unit and all accessories are in good working order e Inspect for damage to the generator and all its connections e Verify that the appropriate accessories and adapters are present e Inspect all cords and connectors for signs of wear damage and abrasion e Verify that no errors occur when you turn on the unit Setup Safety Hazardous Electrical Output This equipment is for use only by trained licensed physicians Electric Shock Hazard Connect the generator power cord to a properly grounded receptacle Do not use power plug adapters
30. ls One year from date of shipment Footswitches all models One year from date of shipment Force Argon Units One year from date of shipment OptiMumm Smoke Evacuator Two years from date of shipment LigaSure Sterile Single Use Items Sterility only as stated on packaging Sterile Single Use Items Sterility only as stated on packaging Patient Return Electrodes Shelf life only as stated on packaging SurgiStat Il 20 User s Guide This warranty is in lieu of all other warranties express or implied including without limitation the warranties of merchantability and fitness for a particular purpose and of all other obligations or liabilities on the part of Valleylab Valleylab neither assumes nor authorizes any other person to assume for it any other liability in connection with the sale or use of any of Valleylab s products Notwithstanding any other provision herein or in any other document or communication Valleylab s liability with respect to this agreement and products sold hereunder shall be limited to the aggregate purchase price for the goods sold by Valleylab to the customer There are no warranties which extend beyond the terms hereof Valleylab disclaims any liability hereunder or elsewhere in connection with the sale of this product for indirect or consequential damages This warranty and the rights and obligations hereunder shall be construed under and governed by the laws of the State of Colorado USA The sole forum for resolvi
31. matically reduces its power setting to the maximum for Bipolar 30 watts SurgiStat Il 20 User s Guide Activating the Unit gt Important One footswitch activates either monopolar or bipolar footswitching accessories You can change the power setting while you activate the unit If you change the power setting for the mode you are using your change affects the power you are applying to the patient You can increase or decrease power as much as three watts per second while activating the unit For example if you have activated Pure Cut at 50 watts you can increase the Pure Cut power to 60 watts while continuing to activate the unit The power output increases from 50 to 60 watts At the same time you can increase the power setting of the mode that is not currently active For example if you have activated Blend mode at 50 watts you can increase the power setting in the Desiccate mode from 30 to 40 watts The setting for Desiccate increases to 40 watts but the Blend power output remains at 50 watts Monopolar Cut Select the desired Cut power settings by rotating the Cut and Blend Power Control Dial Monopolar Coag Select the mode of operation for coagulation Desiccate or Fulgurate then select the coagulation power settings by rotating the Desiccate Fulgurate and Bipolar Power Control Dial Bipolar Select the mode of operation for Bipolar then select the Bipolar power settings by rotating the Desiccation Fulgurat
32. mode Output Power watts 30 25 20 Generator Setting 20 25 30 SurgiStat II 20 User s Guide 8 15 suomneouioeds edIUYISBL Kalleylab 8 16 SurgiStat II 20 User s Guide Warranty Valleylab a division of Tyco Healthcare Group LP warrants each product manufactured by it to be free from defects in material and workmanship under normal use and service for the period s set forth below Valleylab s obligation under this warranty is limited to the repair or replacement at its sole option of any product or part thereof which has been returned to it or its Distributor within the applicable time period shown below after delivery of the product to the original purchaser and which examination discloses to Valleylab s satisfaction that the product is defective This warranty does not apply to any product or part thereof which has been repaired or altered outside Valleylab s factory in a way so as in Valleylab s judgment to affect its stability or reliability or which has been subjected to misuse neglect or accident The warranty periods for Valleylab products are as follows ForceTriad Energy Platform One year from date of shipment Electrosurgical Generators One year from date of shipment RFG 3C Plus Lesion Generator One year from date of shipment LigaSure Vessel Sealing System One year from date of shipment LigaSure Reusable Instruments One year from date of shipment Mounting Fixtures all mode
33. n clean the generator and ship it to Valleylab for service Step 1 Obtain a Return Authorization Number Call the Valleylab Customer Service Center for your area to obtain a Return Authorization Number Have the following information ready when you call Hospital clinic name customer number Telephone number Department address city state and zip code Model number Serial number Description of the problem Type of repair to be done SurgiStat Il 20 User s Guide Returning the Generator for Service Service Center Step 2 Clean the Generator Electric Shock Hazard Always turn off and unplug the generator before cleaning Do not allow fluids to enter the generator chassis Do not sterilize the generator Notice Do not clean the generator with abrasive cleaning or disinfectant compounds solvents or other materials that could scratch the panels or damage the generator gt Turn off the generator and unplug the power cord from the wall outlet Thoroughly wipe all surfaces of the generator and power cord with a mild cleaning solution or disinfectant and a damp cloth Follow the procedures approved by your institution or use a validated infection control procedure Step 3 Ship the Generator A Attach a tag to the generator that includes the Return Authorization Number and the information hospital phone number etc listed in Step 1 Obtain a Return Authorization Number Be sure the ge
34. nces will contribute to increased fire and explosion hazards in the operating room Flammable substances such as alcohol based skin prepping agents and tinctures Naturally occurring flammable gases that may accumulate in body cavities such as the bowel Oxygen enriched atmospheres Oxidizing agents such as nitrous oxide N20 atmospheres The sparking and heating associated with electrosurgery can provide an ignition source Observe fire precautions at all times When using electrosurgery in the same room with any of these substances or gases prevent their accumulation or pooling under surgical drapes or within the area where electrosurgery is performed Electric Shock Hazard Connect the power cord to a properly polarized and grounded power source with the frequency and voltage characteristics that match those listed on the back of the unit Do not use power plug adapters Electric Shock Hazard Always turn off and unplug the generator before cleaning Fire Hazard Do not use extension cords Patient Safety Use the generator only if the self test has been completed as described Otherwise inaccurate power outputs may result Failure of the high frequency electrosurgical equipment could result in an unintended increase of output power The instrument receptacles on this generator are designed to accept only one instrument at a time Do not attempt to connect more than one instrument at a time into a given receptacle Doin
35. nd mode Activation Pure Cut Indicator Illuminates when either Pure Cut or Blend mode is Blend Selector When pressed selects the Blend mode Cut and Blend Power Control Dial Increases or decreases the Cut or Blend Indicator Blend power output in increments of llluminates when one watt Blend mode is selected SurgiStat II 20 User s Guide 2 3 So oe1dodoy pue SIO BeIIPLU SJO11U0J Coag and Bipolar Controls Coag and Bipolar Controls Figure 2 3 Controls for the Desiccate Fulgurate and Bipolar modes Coag and Bipolar Coag and Bipolar Power Display watts Activation Indicator Indicates the power set Illuminates when Desiccate Desiccate Indicator for any Coag or Bipolar Fulgurate or Bipolar modes Iluminates when mode are activated Desiccate mode is selected Desiccate Selector When pressed selects the Desiccate mode Fulgurate Indicator Illuminates when Fulgurate mode is COAG selected siccate Fulgurate Fulgurate Selector When pressed selects the Bipolar Fulgurate mode Bipolar Selector When pressed selects the Bipolar mode Coag and Bipolar Power Control Dial Increases or decreases the Coag or Bipolar power output in increments of one watt Bipolar Indicator Illuminates when Bipolar mode is selected 2 4 SurgiStat Il 20 User s Guide Indicators Indicators Figure 2 4 Indicators for power return electrodes and footswit
36. nerator is completely dry before you pack it for shipment Package it in its original shipping container If the original shipping container is not available request one when obtaining your Return Authorization Number Oo Ship the generator prepaid to the Valleylab Service Center For a complete list of service centers worldwide please refer to the Valleylab website http www valleylab com valleylab international service world html SurgiStat II 20 User s Guide seunpeooJg pue AJij0g 1redeu Kalleylab 74 SurgiStat II 20 User s Guide Technical Specifications All specifications are nominal and subject to change without notice A specification referred to as typical is within 2096 of a stated value at room temperature 25 C 77 F and a nominal input power voltage SurgiStat Il 20 User s Guide 8 1 Performance Characteristics Performance Characteristics Input Power 110 120 Volt Nominal input power voltage for calibration 120 V Mains line frequency range nominal 50 60 Hz Power consumption 360 VA Fuses 2 5A Slow Blow Duty Cycle Under maximum power settings and rated load conditions Pure Cut 120 watt 500 Q load the generator is suitable for activation times of 10 seconds on 30 seconds off for one hour Dimensions and Weight Width 26 cm 10 25 in Depth 30 5 cm 12 in Height 15 2 cm 6 in Weight lt 6 5 kg lt 14 Ibs
37. ng disputes arising under or relating in any way to this warranty is the District Court of the County of Boulder State of Colorado USA Valleylab its dealers and representatives reserve the right to make changes in equipment built and or sold by them at any time without incurring any obligation to make the same or similar changes on equipment previously built and or sold by them SurgiStat II 20 User s Guide
38. nitoring system Do not wrap the accessory cords or patient return electrode cords around metal objects This may induce currents that could lead to shocks fires or injury to the patient or surgical team SurgiStat Il 20 User s Guide 1 5 Jojejouas e2iDunsoJ199 3 rexsiBans eui Buronpoutul Safety Cautions At no time should you touch the active electrode or bipolar forceps A burn could result Do not stack equipment on top of the generator or place the generator on top of electrical equipment These configurations are unstable and or do not allow adequate cooling Provide as much distance as possible between the electrosurgical generator and other electronic equipment such as monitors An activated electrosurgical generator may cause interference with them Nonfunction of the generator may cause interruption of surgery A backup generator should be available for use Do not turn the activation tone down to an inaudible level The activation tone alerts the surgical team when an accessory is active When using a smoke evacuator in conjunction with the electrosurgical generator place the smoke evacuator at a distance from the generator and set the generator volume control at a level that ensures that the activation tones can be heard The use of high frequency current can interfere with the function of other electromagnetic equipment When high frequency surgical equipment and physiological monitoring equipment
39. ower vs generator settings for Pure Cut mode Figure 8 4 Output power vs impedance for Blend mode Output Power watts Output Power watts B 558 88823232 B B8 3 o 0 5 10 5 20 25 30 3 0 6 5 55 6 6 70 7 8 8 WM 100 10 110 115 120 Generator Setting 1007 t T t 500 1000 1500 Load Resistance ohms 2000 t 1 2500 3000 SurgiStat II 20 User s Guide 8 9 suomneouioeds eoiuu29 Output Power Curves Figure 8 5 Peak voltage vs power setting for Blend mode Figure 8 6 Output power vs generator settings for Blend mode Open Circuit Peak Voltage volts Output Power watts 2500 2000 1500 1000 500 1 5 10 15 20 25 30 35 4 45 50 55 60 65 70 75 80 85 90 Output Power Setting watts Generator Setting 8 10 SurgiStat II 20 User s Guide Output Power Curves Figure 8 7 Output power vs impedance for Desiccate mode Figure 8 8 Peak voltage vs power setting for Desiccate mode Monopolar Coag Curves These measurements were taken using short 0 5 meter leads 100 90 Output Power watts 0 500 1000 1500 2000 2500 3000 Load Resistance ohms 4000 2 3500 o 3000 2 2500 2000 S9 1500 E 1000 d 500 0 g 1 5 10 15 20 25 30 35 40 45 50 55 60 65 70 75 80 Oo 8 Output Power Setting watts O SurgiStat Il 20 User s Guide 8 11 suomneouioeds eoiuu29 Output
40. re 8 2 Figure 8 3 Figure 8 4 Figure 8 5 Figure 8 6 Figure 8 7 Figure 8 8 Figure 8 9 Figure 8 10 Figure 8 11 Figure 8 12 Figure 8 13 Figure 8 14 Figure 8 15 Layout of controls indicators and receptacles on the front panel 2 2 Controls for the Cut and Blend modes 2 3 Controls for the Desiccate Fulgurate and Bipolar modes 2 4 Indicators for power return electrodes and footswitch control 2 5 Location of the unit power switch and front panel receptacles 2 6 Layout of connectors and controls on the rear panel 2 7 Output power vs impedance for Pure Cut mode 8 8 Peak voltage vs power setting for Pure Cut mode 8 8 Output power vs generator settings for Pure Cut mode 8 9 Output power vs impedance for Blend mode 8 9 Peak voltage vs power setting for Blend mode 8 10 Output power vs generator settings for Blend mode 8 10 Output power vs impedance for Desiccate mode 8 11 Peak voltage vs power setting for Desiccate mode 8 11 Output power vs generator settings for Desiccate mode 8 12 Output power vs impedance for Fulgurate mode 8 12 Peak voltage vs power setting for Fulgurate mode 8 13 Output power vs generator settings for Fulgurate mode 8 13 Output power vs impedance for Bipolar mode 8 14 Peak voltage vs power setting for Bipolar mode 8 14 Output power vs generator settings for Bipolar mode 8 15 SurgiStat II 20 User s Guide vii Introducing the SurgiStat Il Electrosurgical Generator T
41. rforation and irreversible tissue necrosis For surgical procedures where the high frequency current could flow through parts of the body having a relatively small cross sectional area the use of bipolar techniques may be desirable to avoid unwanted coagulation In some circumstances the potential exists for alternate site burns at points of skin contact e g between the arm and the side of the body This occurs when electrosurgical current seeks a path to the patient return electrode that includes the skin to skin contact point Current passing through small skin to skin contact points is concentrated and may cause a burn This is true for grounded ground referenced and isolated output generators To reduce the potential for alternate site burns do one or more of the following Avoid skin to skin contact points such as fingers touching leg when positioning the patient Place 5 to 8 cm 2 to 3 in of dry gauze between contact points to ensure that contact does not occur Position the patient return electrode to provide a direct current route between the surgical site and the return electrode that avoids skin to skin contact areas n addition place patient return electrodes according to the manufacturer s instructions Potential for alternate site burns increases if the return electrode is compromised Valleylab recommends the use of split plate patient return electrodes and Valleylab generators with a contact quality mo
42. rol Indicator illuminates Connect a single plate patient return electrode to the Return Electrode receptacle of the unit Verify that the green single plate patient return electrode indicator illuminates Press the Cut pedal on the footswitch Verify that the Cut and Blend Activation Indicator illuminates and that the system generates the Cut activation tone While activating the Cut mode rotate the volume control over the full range to verify that the sound is audible throughout the range SurgiStat II 20 User s Guide peueijs Buje Performance Checks 5 Press the Coag pedal on the footswitch Verify that the Desiccate Fulgurate and Bipolar Activation Indicator illuminates and that the system generates the Coag activation tone 6 While activating the Coag mode rotate the volume control over the full range to verify that the sound is audible throughout the range Checking Monopolar Mode with Handswitch 1 Connect a handswitching handpiece to the Monopolar Handswitching receptacle 2 Activate one at a time the Cut and Coag handswitching controls 3 Verify that each control causes the correct indicator to illuminate and tone to sound Performance Checks After the unit has passed the preliminary functional test it is ready for performance testing A qualified biomedical engineer who is thoroughly familiar with electrosurgical devices should conduct this testing The testing should include checking al
43. roubleshooting This section includes error code descriptions and actions to take to resolve them SurgiStat Il 20 User s Guide 6 1 General Troubleshooting Guidelines General Troubleshooting Guidelines The SurgiStat II includes automatic self diagnostics If the diagnostics detect an error the system displays an error code sounds an audible tone and deactivates the unit output power Correcting Malfunctions Most error codes result from faults in accessories attached to the unit The following table lists the error codes describes the error and recommends actions to take to resolve the error Error Code Description Recommended Action F1 on the Handswitch or monopolar footswitch 1 Turn off then turn on the generator Do not press Cut Blend cut pedal may be stuck buttons or accessory activation devices during the self Display Handswitch or monopolar footswitch test F1 on the coag pedal may be stuck 2 If the alarm number reappears disconnect all Desiccate accessories Turn off then turn on the generator again Fulgurate A Bi 3 If the problem persists replace the handpiece or ipolar footswitch and repeat Step 1 display 4 Ifthe alarm number reappears record the number and call the Valleylab Service Center F2 Cut and Coag buttons activated The unit does not allow simultaneous activation of the cut simultaneously pencil or footswitch and coagulation modes Release either the cut or coag button on the
44. s of time Plug the generator power cord into the AC Power Cable Receptacle on the rear panel Plug the generator power cord into a grounded receptacle Turn on the generator by pressing the power switch On l Verify the following e All visual indicators and displays on the front panel illuminate e Activation tones sound to verify that the speaker is working properly Ifthe self test is successful a tone sounds Verify the following e A Cut mode is selected and a Coag or Bipolar mode is selected e Each display shows a power setting The unit automatically powers up to the most recently used power settings The Patient Return Electrode Alarm Indicator illuminates red If the self test is not successful an alarm tone sounds A number may momentarily appear in the Cut display and in most cases the generator is disabled Note the number and refer to Troubleshooting Section 6 Once the self test is successful connect the accessories and set the generator controls Refer to Preparing for Monopolar Surgery or Preparing for Bipolar Surgery later in this section Preparing for Monopolar Surgery Applying the Patient Return Electrode Monopolar surgery requires a patient return electrode Valleylab recommends using return electrode contact quality monitoring system RECQMS patient return electrodes to maximize patient safety The REM system is designed to minimize the risk of burns at the return electrode site
45. sing a footswitch activated device connect an appropriate Valleylab footswitch to the Footswitch Connecting Socket on the rear of the unit Use only a Valleylab footswitch with the SurgiStat II 20 generator Use of an incompatible footswitch may cause unexpected output Preparing for Bipolar Surgery 1 Select the Bipolar Mode by pressing the Bipolar Mode Selector The Bipolar Mode Indicator will illuminate Note The unit automatically changes to Bipolar Footswitching mode when you select Bipolar mode 2 Connect a Bipolar cable to the Bipolar Receptacle 3 Connectthe appropriate Valleylab Footswitch to the Footswitch Receptacle on the rear of the unit 4 Connect a forceps instrument to the Bipolar cable SurgiStat Il 20 User s Guide 4 5 Ye1si amp ung eui Bus Activation Safety Activation Safety Do not wrap the accessory cords or patient return electrode cords around metal objects This may induce currents that could lead to shocks fires or injury to the patient or surgical team Danger Fire Explosion Hazard Do not use the SurgiStat Il electrosurgical generator in the presence of flammable anesthetics Fire Explosion Hazard The following substances will contribute to increased fire and explosion hazards in the operating room Flammable substances such as alcohol based skin prepping agents and tinctures Naturally occurring flammable gases that may accumulate in body cavities such as the bowel Oxy
46. tential cable Do not clean the generator with abrasive cleaning or disinfectant compounds solvents or other materials that could scratch the panels or damage the generator 1 U S Department of Health and Human Services National Institute for Occupational Safety and Health NIOSH Control of Smoke from Laser Electric Surgical Procedures HAZARD CONTROLS Publication No 96 128 September 1996 SurgiStat II 20 User s Guide J01eJeuo5 eoiDunsoJ199 3 rexsiGans y Buronpoutul Kalleylab SurgiStat II 20 User s Guide Controls Indicators and Receptacles This section describes the front and rear panels including all controls indicators receptacles the fuse drawer and ports SurgiStat Il 20 User s Guide 2 1 Front Panel Front Panel Figure 2 1 Layout of controls indicators and receptacles on the front panel SurgiStat Il Pure Cut Q Desiccate Q Blend Q uguae Q Bipolar Q O MA O lt D eca Ealleylab PATIENT ALARM POWER PATIENT e nn BIPOLAR HDO leoo eo 2 2 SurgiStat Il 20 User s Guide Cut and Blend Controls Cut and Blend Controls Figure 2 2 Controls for the Cut and Blend modes Cut and Blend Cut Indicator n di E ower Displa Illuminates when pay Pure Cut mode is inu the selected power set for the Q Pure Cut or Blend Cut Selector mode When pressed selects the Pure Cut CUT Cut and Ble
47. tromagnetic equipment When high frequency surgical equipment and physiological monitoring equipment are used simultaneously on the same patient place any monitoring electrodes as far as possible from the surgical electrodes Do not use needles as monitoring electrodes during electrosurgical procedures Inadvertent electrosurgical burns may result To avoid the possibility of an electrosurgical burn to either the patient or the physician do not allow the patient to come in contact with a grounded metal object during activation When activating the unit do not allow direct skin contact between the patient and the physician Remove any loose fitting jewelry from the patient before activation Studies have shown that smoke generated during electrosurgical procedures can be potentially harmful to patients and the surgical team These studies recommend adequately ventilating the smoke by using a surgical smoke evacuator or other means Examine all accessories and connections to the electrosurgical generator before use Ensure that the accessories function as intended Improper connection may result in arcs sparks accessory malfunction or unintended surgical effects When not using active accessories place them in a holster or in a clean dry nonconductive and highly visible area not in contact with the patient Inadvertent contact with the patient may result in burns 1 U S Department of Health and Human Services National Institute
48. umber reappears upon restarting the unit record the number and call the Valleylab Service Center Turn the unit off Allow the unit to cool for 20 minutes If the unit displays any other error code it requires service SurgiStat II 20 User s Guide 6 3 Gunoouso qnou Kalleylab 6 4 SurgiStat II 20 User s Guide Repair Policy and Procedures Refer to this section for information on The manufacturer s responsibility Returning the generator for service Returning circuit boards Finding service centers SurgiStat II 20 User s Guide 7 1 Responsibility of the Manufacturer Responsibility of the Manufacturer Valleylab is responsible for the safety reliability and performance of the generator only under the following circumstances The user has followed the installation and setup procedures in this manual Persons authorized by Valleylab performed assembly operation readjustments modifications or repairs The electrical installation of the relevant room complies with local codes and regulatory requirements such as IEC and BSI Equipment use is in accordance with the Valleylab instructions for use For warranty information refer to Chapter 9 Warranty Returning the Generator for Service Before you return the generator call your Valleylab representative for assistance If instructed to send the generator to Valleylab first obtain a Return Authorization Number The
49. y accessories are damaged notify Valleylab Customer Service immediately Do not use any damaged equipment Place the SurgiStat II on any flat surface with a tilt angle not more than 10 The unit relies on natural convection cooling Do not block its bottom or rear vents Ensure that air flows freely on all sides of the unit Connect the power cord to a properly polarized and grounded power source with the frequency and voltage characteristics that match those listed on the back of the unit Upon initial installation of the unit perform the following checks Refer to the figures in the previous chapter for the location of connectors and controls At no time should you touch the active electrode or bipolar forceps A burn could result Setting Up the Unit 1 Verify that the Power Switch is in the Off O position and that no accessories are connected to the unit 2 Connecta hospital grade power cable to the AC power cable receptacle on the back of the unit then to a properly grounded wall outlet e Connect a two pedal footswitch to the appropriate footswitch receptacle on the back of the unit Use only a Valleylab footswitch with the SurgiStat II 20 generator Although other types of footswitches may fit they may not be compatible Use of an incompatible footswitch may cause unexpected output SurgiStat Il 20 User s Guide Function Checks 4 5 Do not connect a patient return electrode at this time Turn the unit

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