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Surgistat II coagulation Service Manual

1. l Bi Fulguration polar or Monopolar 9 M I FREE Line Transformer High Voltage DC RF Amplifier 9 Monopolar Output Selector Cut Output S I Supply Select Relay Transformer Blend Coag Select Relay A l l a I Low Voltage DC Main RE Dri Bipolar Output Bipolar Supply Board rive Transformer Output I A l aAa SEE ege 1 pond DC Supply Check Digital PWM ones tl Circuit i Patient Plate Sensing i Sense Input I E Handsense i Speaker Circuit System Logic Footsense Fr m I I I I l gt I l Temperature l Sensor Circuit l I I I Front Panel Front Panel I I Display Controls l l I Set e Ee Er rd rd Bed Ee rd ed Dec Dh D De Dec De See Sc sl Functional Overview of Key Circuits The following descriptions highlight the main circuits High Voltage DC Supply The unit incorporates a high voltage power supply to generate the RF output power The high voltage power supply delivers an unregulated DC output for the RF output The nominal DC voltage from the high voltage power supply is 87 VDC 5 V Low Voltage DC Supplies The unit incorporates four regulated low voltage levels to control generator operations They are 15 VDC 12 VDC 8 VDC and 5 VDC The 15 VDC circuit supplies power for all of the request sense circuits the switching of the mode relays and the audio circuit The 12 VDC circuit supplies power
2. eese 5 4 How to Check the Bipolar Mode with Footswitch eee ee nn 5 4 How to Check the Monopolar Mode with Footswitch s ssssssssssesesseesssesesseesseseesaeseeeeeeeeseeseneeeaeaeens 5 4 How to Check the Monopolar Mode with Handswitch eeeeseesseeetenenn nnns 5 5 Operating the Un Y 5 5 Section 6 Maintenance Cleaning Kanu 6 2 Performing Periodic Inspection e i rrr r rnan nnnn RR ER ER ER ER ER ER EE RE A RE ESR ESR ESR HRE ESR EE Brna 6 2 Replacing a 6 3 Section 7 Troubleshooting Recommended Equipment for Troubleshooting crees nt RE RE RR 7 2 Troubleshooting the lte EE 7 2 Inspecting the Generator RE E ameta tn ne i 7 2 Inspecting the Receptacles m 7 3 Understanding Error Codes and Audio Tones soesenennrnunnt o nn 7 4 Correcting Common ProblemsS i errn n n nnns nn REN 7 6 SurgiStat II Service Manual Section 8 Repair Policy and Procedures Responsibility of the ManufactUrer Lees RR RE RE ERA RR RH REESE ES atas mates mains asma HERE HRB nana 8 2 Returning the Generator for Service RE H RH EHEHn 8 2 Obtain a Return Authorization Number cesses HEHE 8 2 Cl an the Generate PERDE 8 3 Ship the EE 8 3 eet CT 8 3 Section 9 Warranty
3. aeree RH 3 20 iv SurgiStat Il Service Manual Section 4 Theory Of Operation Bloch BE e r 4 2 Functional Overview of adeleg DIN 4 2 High Voltage DU IU ere HL 4 2 Low Voltage DC Supplies RR 4 2 PE Supply Check Circuit kes e ni a 4 3 Temperature SENSING Circuit akse siv ke os ko ke va e k kk ek kk n kk a in a ke A ko An ko AK EEN 4 3 Four Request Activation Sensing Circuits HEHE 4 3 Speaker GIOUIL me 4 3 Patient Return Electrode Sensing Circuit HEHE nn 4 4 RE Amplifier ere E 4 4 Monopolar Select dell 4 4 Monopolar Bipolar Select Relays eee eee ELLE ER 4 4 Controls and ato fe Mo E Aka 4 5 Digital PWM GWO UNM Es akse danita 4 5 system Bee UE 4 5 SurgiStat II Control Signal Inputs and Outputs HEHE 4 6 Section 5 Generator Operation Inspecting the Generator and Accessories HEHE 5 2 Service Persornnel Safely iiu terit erre Eed Adel 5 2 Installation and Placement 5 3 Functional Operational Checks s HRE ta tn sn amete sn LEELEREE 5 3 How to Set Up and Start the SurgiStat Il Unit esse nan 5 3 How to Check the Patient Return Electrode Alarm Function
4. Palleylab Service Manual SurgiStat Il Electrosurgical Generator Preface 0086 This Service Manual and the eguipment it describes are for gualified technicians who maintain the SurgiStat II Electrosurgical Generator Additional user information is available in the SurgiStat II User s Guide This document covers technical descriptions of the SurgiStat II generator including its physical appearance all operator controls and indications operational specifications component functional descriptions module level diagrams of the electronic circuits used and troubleshooting guidelines with chart comparisons The SurgiStat II was constructed with the highest quality components and was built in an ISO 9000 registered environment In the unlikely event that your generator fails within one year of purchase date Valleylab will warranty the product and effect factory repairs Please refer to Section 8 Repair Policies and Procedures for what is covered how long and how to obtain a Return Authorization Number Federal USA laws restrict this device to sale by or on the order of a physician Equipment covered in this manual SurgiStat T Electrosurgical Generator 120 VAC Model Surg II 20 SurgiStat II Electrosurgical Generator 240 VAC Model Surg II 8 SurgiStat II Electrosurgical Generator 100 VAC Model Surg II J Valleylab Part Number 1003626 Effective Date August 2006 Trademark acknowledgements
5. Matrix switches on the front panel allow mode selection High voltage relays switch and isolate the four monopolar configurations Monopolar Bipolar Select Relays The monopolar bipolar select relays change which output transformer is used to deliver the RF output to the patient SurgiStat II Service Manual System Logic Controls and Indicators The SurgiStat II uses the following controls and indicators Membrane switches These switches switch between modes Displays Seven segment displays indicate the output power in watts e Mode indictors Green LEDs indicate the present mode of the unit e Power control knobs These mechanical encoders adjust the output power for each mode e Power switch A double pole single throw switch snaps into the front bezel This switch supplies the AC mains current to the generator Digital PWM Circuit The digital PWM circuit controls the output power of the unit The system logic uses this digitally controlled signal to provide a precise signal to the RF drive The power setting generated by the user on the front of the unit determines the pulse width When the user sets the power the system logic determines what the pulse width needs to be to deliver the requested output The control logic uses a field programmable gate array as the generator brain This system interprets all inputs and delivers the correct corresponding outputs This system controls every operation o
6. Valleylab ForceTriad Force Fx 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 II Service Manual Safety Precautions when Operating the Generator 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 eguipment To promote the safe use of the SurgiStat II electrosurgical generator please refer to the User s Guide for standard operating precautions Applicable Safety Standards CSA C22 2 NO 601 1 M90 UL60601 1 IEC 60601 2 2 1998 90 Class 1 Eguipment Type CF CENELEC EN 60601 1 2 FCC Part 15 Class A IEC 60601 1 2nd Edition 1988 Conventions Used in this Guide Indicates a potentially hazardous situation which if not avoided could result in death or serious injury Indicates a hazardous si
7. as recommended below according to the maximum output power of the communications equipment Rated maximum output power of transmitter W 150 kHz to 80MHz 80MHz to 800MHz 800MHz to 2 5GHz d 1 21P d 1 2 P d 2 3 P 0 01 0 12m 0 12m 0 23 m 0 1 0 38 m 0 38 m 0 73 m 1 1 2 m 1 2 m 2 3 m 10 3 8 m 3 8 m 7 3m 100 12m 12 m 23 m For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At a 80MHz and 800MHZ the separation distance for 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 SurgiStat II Service Manual Output Power Characteristics Maximum Output for Bipolar and Monopolar Modes Power readouts agree with actual power into rated load to within 20 or 5 W whichever is greater All measurements were taken at the nominal input power voltage used for calibration Crest Factor Mode Output Power Output Frequency Repetition Rate Vp p max Rated Load Cut 120 W 500 Q 357 kHz 50 kHz N A 2 5 kV 2 9 20 Blend 90 W 800 Q 357 kHz 50 kHz 30 kHz 5 kHz 3 5 kV 3 3 20
8. Check and correct the chassis ground connections for the monitor and if applicable for the generator 2 Check other electrical eguipment in the room for defective grounds Electrical eguipment is grounded to different objects rather than a common ground Generator may respond to the resulting voltage differences between grounded objects Plug all electrical eguipment into line power at the same location Malfunctioning monitor Replace the monitor Interference with other devices only when generator is activated Metal to metal sparking High settings used for fulguration Check all connections to the generator patient return electrode and accessories Use lower power settings for fulguration or select the Desiccate mode Electrically inconsistent ground wires in the operating room If interference continues when the generator is activated the monitor is responding to radiated freguencies Verify that all ground wires are as short as possible and go to the same grounded metal Check with the manufacturer of the monitor Some manufacturers offer RF choke filters for use in monitor leads The filters reduce interference when the generator is activated and minimize the potential for an electrosurgical burn at the site of the monitor electrode 7 8 SurgiStat II Service Manual Situation Possible cause Recommended action Pacemaker interference Intermittent connect
9. Desiccate 80 W 1000 Q 475 kHz 50 kHz 57 kHz 5 kHz 4 5 kV 5 5 2096 Fulgurate 40 W 1000 Q 410 kHz 50 kHz 25 kHz 5 kHz 6 5 kV 7 7 2096 Bipolar 30 W 200 Q 520 kHz 50 kHz 32 kHz 5 kHz 2 0 kV 6 9 20 An indication of a waveform s ability to coagulate bleeders without a cutting effect SurgiStat II Service Manual suoneouioeds edILYIBL 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 lt 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 3 1 Output power vs impe ance for Pure Cut mode 1751 1507 75 Output Power watis Figure 3 2 Peak voltage vs power setting for Pure Cut mode 1800 1600 1400 1200 1000 800 600 400 200 Open Circuit Peak Voltage volts 2007 1257 1007 T t 1 500 1000 1500 2000 3000 Load Resistance ohms f 04 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 3 12 SurgiStat II Service Manual Figure 3 3 Output power vs generator settings for Pure Cut mode Output Power w
10. O HI d SH Valleylab Bipolar Receptacle Accepts standard cables for bipolar handpieces POWER RGS a 90 09 A Power On Off Monopolar Handswitching Switch Receptacle Turns the unit Accepts standard three pin on or off Patient Return Electrode handpieces Connect Receptacle handswitching accessories Accepts a standard patient Monopolar Footswitchin return electrode plug p g Receptacle Accepts cables or adapters equipped with standard Bovie 12 active plugs Connect footswitching accessories SurgiStat II Service Manual 2 7 se 921d9090H pue SIOJEDIPU SIOJJUOJ Rear Panel Figure 2 6 Layout of connectors and controls on the rear panel Power Cable Receptacle Eguipotential Connector Volume Control and Fuse Holder Allows attaching a standard Controls the volume of the audible tones Connects a hospital grade grounding cable to chassis ground produced during normal unit activation power cord to supply AC for additional protection against To increase volume rotate the knob mains power to the unit leakage current clockwise MONOPOLAR FOOTSWITCH Serial Number Label Specifies the unit model number serial number nominal line voltage frequency current and power consumption Footswitch Receptacle Accepts the E6008 or E6008B monopolar footswitch Use the monopolar footswitch for both monopolar
11. RF Output This minimizes the potential of alternate site burns SurgiStat II Service Manual Unit Description Standard Front Panel These connectors accept the latest Connectors monopolar and bipolar instruments Self Diagnostics These diagnostics continually monitor the unit to ensure proper performance Whenever they detect a problem medical personnel receive audible and visual alarm responses and the output is suspended until the alarm condition is cleared The SurgiStat II electrosurgical generator is a self contained unit consisting of the main enclosure and power cord The main components incorporated in the generator are Front Panel Components Power switch two dials for controlling power output membrane switches for selecting modes receptacles for connecting electrosurgical accessories and indicators that show the current settings and patient return electrode status e Rear Panel Components Volume control footswitch receptacle power cable receptacle and fuse holder and equipotential grounding lug Internal Components Display board main board pad sensing module speaker board and relay board Safety Precautions when Testing the Generator Before testing this generator it is important that you read understand and follow the instructions supplied with it Also be familiar with any other equipment used to install and test the generator General Warnings Cautions and Notices Use
12. Section A Board Drawings and Schematics Mam Boa ctia sacha cacti cai Soca sete Se cei EZ A 3 Power SUPPLY sik kk kak n kk ak on n ka a ik kk ik an ik ak n ET EDEL EA in nw era A 4 REAmplifier ele konne do ai elei EEN A 5 Request Sense Circuit Hand A ES A 6 Request Sense Circuit Hand Beo A 7 Request Sense Circuit Foot A oe SEE kankou ei e ko ok e t a di ou maaa aran naasta diaii nadasa iaiia A 8 Reguest S tise Giteuit FOOL om A 9 Display ere HE A 10 N IER A 11 Monopola Select CirCuit si eege labu ka sinou unav A 12 Main Printed Circuit Board BE A 13 Display Printed Circuit Boards PDC A 14 Relay Printed Circuit Board EE A 15 Front scr PACI ue E A 16 Back Panel ASSOm DW eege A 17 Final Assembly evit vese oo kak ik kb kn a n A n ED n D e rain A 18 vi SurgiStat II Service Manual The SurgiStat Il Electrosurgical Generator This 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 Service Manual 1 1 Functional Description The SurgiStat II is a multipurpose electrosurgical generator for use in physician s
13. a distance away from the generator Set the generator s volume control on the rear panel at a level that ensures all activation tones may be heard 5 2 SurgiStat II Service Manual Notice If required by local codes connect the generator to the hospital egualization connector with an eguipotential cable There is an eguipotential connector on the rear of the unit Connect the power cord to a wall outlet having the correct voltage Otherwise product damage may result Installation and Placement Place the SurgiStat II Electrosurgical Generator on any flat surface with a tilt angle of not more than 10 degrees The unit relies on natural convection cooling Do not block the 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 Functional Operational Checks Upon Initial installation of the unit perform the following checks Refer to the figures in Section 2 Controls Indicators and Receptacles for the location of the controls and connectors At no time should you touch the active electrode or bipolar forceps A serious burn could result How to Set Up and Start the SurgiStat II Unit Verify that the power switch is in the Off O position and that no accessories are connected to the unit N Connect a hospital grade pow
14. and bipolar activation Use only a Valleylab monopolar footswitch with a SurgiStat Il generator Use of an incompatible footswith may cause unexpected output 2 8 SurgiStat II Service Manual Symbols on the Front Panel Symbols Description Cut Controls Cut mode NO Blend mode xv Coag Controls Desiccate mode Fulgurate mode ZIN M Bipolar mode Indicators cy Single plate patient return electrode C O Split plate patient return electrode 9 Monopolar footswitch control Footswitch on the selector button Bipolar footswitch control EN SurgiStat II Service Manual 2 9 Sa oe1dodoy pue SJOJEOIPU SIOJJUO 9 Symbols Description Power Switch and Handpiece Connectors f Read instructions before use dei Type CF eguipment Patient return electrode RF isolated patient connections are isolated from earth at high freguency Caution high voltage gt Fl ANT Monopolar output Bipolar output 2 10 SurgiStat II Service Manual Symbols on the Rear Panel Symbols on the Rear Panel Symbols Description te v A Eguipotential ground stud Nonionizing radiation Volume control Danger Explosion risk if used with flammable anesthetics Monopolar footswitch Read instructions before use SurgiStat II Service Manual 2 11 se 921d990H pue SIOJEDIPU SIOJJUO 9 Kalleylab 2 12 Surgi
15. buttons do not operate correctly when pressed Loose or disconnected cable between main board and display board Loose or disconnected cable between front panel overlay and display board Damaged front panel overlay Contact your Valleylab Service Center Generator is on and the accessory is activated but generator does not deliver output Malfunctioning footswitch or handswitching instrument 1 Turn off the generator Check and correct all accessory connections 2 Turn on the generator 3 Replace the accessory if it continues to malfunction Display board malfunction Contact your Valleylab Service Center Power set too low Increase the power setting An error condition exists 1 Check the cut and coag displays for an error code number 2 Note the number and refer to the error codes descriptions in this section Main board malfunction RF output stage malfunction Contact your Valleylab Service Center Footswitch will not activate output Malfunctioning or damaged footswitch receptacle Footswitch activation signal lost on main board Contact your Valleylab Service Center Incompatible footswitch Use only a Valleylab footswitch with the SurgiStat II generator SurgiStat II Service Manual 7 7 Gunoouso qnou Situation Possible cause Recommended action Continuous monitor interference Faulty chassis to ground connections 1
16. cm 6 in lt 6 5 kg lt 14 Ibs SurgiStat II Service Manual Operating Parameters Ambient temperature 10 to 40 C 50 to 104 F range Relative humidity 15 to 75 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 reguirements for IEC 60601 2 2 Activation Tone Volume adjustable 45 to 65 dBA Freguency Cut 1 kHz Blend 1 kHz Desiccation 2 kHz Fulguration 2 kHz Bipolar 2 kHz Duration Continuous while the generator is activated SurgiStat II Service Manual SuoneIIyI59Ads edILYIBL Alarm Tone Volume not 70 dBA 5 dBA adjustable Freguency 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 50 30 Continuous measurement Once the system establishes the single plate electrode r
17. faulty wall receptacle or faulty power cord 1 Check power cord connections generator and wall receptacle 2 Connect the power cord to a functional wall receptacle If necessary replace the power cord Fuse drawer is open or fuses blown 1 Close the fuse drawer If necessary replace the fuse s 2 lf a problem persists contact your Valleylab Service Center Loose or disconnected internal cables Faulty power entry module or connections Faulty power switch Contact your Valleylab Service Center Generator is on but did not complete the self test Alarm condition exists Loose or disconnected internal cables Faulty power switch Main board malfunction Display board malfunction Check the display for an error code Note the number and refer to error code list Contact your Valleylab Service Center Activation and or alarm tones do not sound speaker is malfunctioning Loose or damaged connection between speaker board and main board Loose or disconnected cable between main board and display board Main board malfunction Display board malfunction Contact your Valleylab Service Center Blank or confusing LED display Faulty ribbon cable between main board and display board Display board malfunction Contact your Valleylab Service Center 7 6 SurgiStat II Service Manual Situation Possible cause Recommended action Mode
18. offices and surgi centers It provides unsurpassed performance flexibility reliability and user convenience in one compact package The SurgiStat II generator includes digital technology This new technology is evident in the self checking circuitry and error code readouts The unit offers monopolar and bipolar electrosurgical operations The following are SurgiStat II key advantages and benefits Power Capabilities Two Levels of Coagulation Desiccation and Fulguration Up to 120 watts W of Pure Cut 500 ohms Up to 90 W of Blend 800 Up to 80 W of Desiccation 2 1000 Up to 40 W of Fulguration 1000 Q Up to 30 W of Bipolar 200 Desiccation provides precise control of bleeding in localized areas Fulguration provides greater control of bleeding in highly vascular tissue over broader tissue surface areas Return Electrode Monitoring System Memory The unit incorporates a return electrode contact guality monitoring system RECOMS This system determines the type of patient return electrode attached single plate or split plate It also continuously monitors the contact impedance between the patient and the split plate patient return electode Contact impedance is only monitored when approved split plate patient return electrodes are used The generator automatically powers up to the last modes selected and previously set power settings Isolated Floating Radio Freguency
19. the unit An alarm sounds during all alarm conditions You cannot adjust the volume of this alarm SurgiStat II Service Manual 2 3 So oe1dodoy pue SIO BDIPU SIOJJUO 9 Cut and Blend Controls Figure 2 2 Controls for the Cut and Blend modes Cut and Blend Cut Indicator Power Display Illuminates when watts Pure Cut mode is i Indicates the selected power set for the Pure Cut or Blend mode Cut Selector When pressed selects the Pure CUT Cut and Blend Cut mode Activation Pure Cut Indicator IIluminates when either Pure Cut or Blend mode is Blend activated Blend Selector When pressed selects the Blend Cut and Blend Power mode Control Dial Increases or decreases the Blend Indicator Cut or Blend power output in Illuminates when increments Blend mode is of one watt selected 2 4 SurgiStat II Service Manual 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 i Indicates the power set Illuminates when Desiccate Desiccate Indicator for any Coag or Bipolar Fulgurate or Bipolar modes lluminates when mode are activated Desiccate mode is selected Desiccate Selector When pressed selects the Desiccate mode Fulgurate Indicator IIluminates when Fulgurate mode is selected Desiccate ZIN COAG Fulg
20. 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 Remove the two fuses and 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 Then slide the drawer out Power Cable Receptacle Fuse Drawer replace them with new fuses with the same values Insert the fuse drawer into the power cable receptacle Use the following fuses Surg ll 20 Surg li 8 Surg Il J 110 120 V 220 240 V 90 110 V VAC 250 250 250 Amps 5 0A 3 15A 5 0A Type Slow Blow Slow Blow Slow Blow Size 5 x 20 mm 5 x 20 mm 5 x 20 mm SurgiStat II Service Manual eoueuelure N Kalleylab 6 4 SurgiStat II Service Manual Troubleshooting This section includes error code descriptions and actions to take to resolve them SurgiStat II Service Manual 7 1 Recommended Eguipment for Troubleshooting Use the following eguipment to troubleshoot the SurgiStat II electrosurgical generator e Digital multimeter with leads e Electrosurgical analyzer or a true RMS voltmeter such as a Fluke 8920 A e Wideband current transformer such as a Pearson 4100 e Noninductive RF load resistors 200 Q 500 800 Q 1000 Q e Oscilloscope dual channel a
21. Always turn off and unplug the generator before cleaning Do not touch any exposed wiring or conductive surfaces while the generator is disassembled and energized Never wear a grounding strap when working on an energized generator When taking troubleshooting measurements use appropriate precautions such as using isolated tools and equipment using the one hand rule etc Potentially lethal AC and DC voltages are present in the AC line circuitry high voltage DC circuitry and associated mounting and heat sink hardware described in this manual These potentials are not isolated from the AC line Take appropriate precautions when testing and troubleshooting this area of the generator High frequency high voltage signals that can cause severe burns are present in the RF output stage and in the associated mounting and heat sink hardware Take appropriate precautions when testing and troubleshooting this area of the generator SurgiStat II Service Manual 1 5 10 E19U91 eoi amp unsoJ129 3 121SIBINS ouj Servicing Read all warnings cautions and instructions provided with this generator before testing Notice There are no internal user serviceable parts For repairs return the generator to Valleylab Cleaning 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 1 6 Surg
22. II Service Manual 3 19 suoieoyioads eoiuuo9 Reference Output Waveforms The following figures are the output waveforms as viewed on an oscilloscope Figure 3 16 Pure Cut mode waveform CH1 1000v Tous div i HORN 100MS zs Figure 3 17 Blend mode waveform CH121000V i i i 10us div DC 100071 i 3 S i S l NORK 10DKAS Ze i J 4 4 A pedo i H i Th acyl h il 1 kou T L ed Li g 1 Pit Fi I t 4 iadi s Ld Li I Tracel P P 3 6000kv 3 20 SurgiStat II Service Manual Figure 3 18 Desiccation mode waveform CH 1s1000V i i 10us div DC 1000 1 Figure 3 19 Fulguration mode waveform CH1 2000V i i gt tOus div NORM 10 suoneouioeds eoiuuo9 SurgiStat II Service Manual 3 21 Figure 3 20 Bipolar mode waveform CH1S500V5 gt us div DC 1000 1 d NORM 100MS s 3 22 SurgiStat II Service Manual Theory Of Operation This section includes the following information Block diagram Functional overview of key circuits System logic Control signal inputs and outputs SurgiStat II Service Manual 4 1 Block Diagram Figure 4 1 Functional block diagram of the SurgiStat II system r
23. Stat II Service Manual Technical Specifications All specifications are nominal and subject to change without notice A specification referred to as typical is within 20 of a stated value at room temperature 25 C 77 F and a nominal input power voltage SurgiStat Il Service Manual Performance Characteristics Input Power Surg II 20 110 120 Volt Surg li 8 220 240 Volt Surg Il J 90 110 Volt Nominal input power voltage for calibration 115 V Nominal input power voltage for calibration 230 V Nominal input power voltage for calibration 100 V Mains line frequency range nominal 50 60 Hz Mains line frequency range nominal 50 60 Hz Mains line frequency range nominal 50 60 Hz Power consumption 360 VA Power consumption 360 VA Power consumption 360 VA Fuses 2 5A Slow Blow Fuses 2 3 15A Slow Blow Fuses 2 5A Slow Blow Duty Cycle Under maximum power settings and rated load conditions Pure Cut 120 W 500 Q load the generator is suitable for activation times of 10 seconds on 30 seconds off for one hour Notice The internal temperature of the unit is constantly being monitored If the temperature rises above 85 C 185 F an alarm sounds the system displays an error code and the system disables output power Dimensions and Weight Width Depth Height Weight 26 cm 10 25 in 30 5 cm 12 in 15 2
24. Sure 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 Service Manual 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 resolving 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 ma
25. atts H 8 8 8 8 3 8 8 3 o 0 5 10 5 20 25 30 35 40 6 50 55 60 65 70 75 80 85 90 95 100 10 110 115 10 Generator Setting Figure 3 4 Output power vs impedance for Blend mode Output Power watts suoneouioeds eoiuuo9 t t t T 1 a 500 1000 1500 2000 2500 3000 Load Resistance ohms SurgiStat II Service Manual 3 13 Figure 3 5 Peak voltage vs power setting for Blend mode Figure 3 6 Output power vs generator settings for Blend mode Open Circuit Peak Voltage volts Output Power watts 2500 2000 1500 1000 500 5 10 15 20 25 30 35 40 45 50 55 60 65 70 75 80 85 90 Output Power Setting watts 20 25 30 35 40 45 Generator Setting 50 55 60 65 70 75 80 85 90 SurgiStat II Service Manual Figure 3 7 Output power vs impedance for Desiccate mode Figure 3 8 Peak voltage vs power setting for Desiccate mode Monopolar Coag Curves These measurements were taken using short lt 0 5 meter leads 100 901 Output Power watts 500 1000 1500 2000 2500 3000 Load Resistance ohms 4000 3500 3000 2500 2000 1500 1000 500 0 1 5 10 15 20 25 30 35 40 45 50 55 60 65 70 75 80 Output Power Setting watts Open Circuit Peak Voltage volts SurgiStat II Service Manual 3 15 suoneouioeds eDIUYIBL Figure 3 9 Output power vs generator settings for Desi
26. ccate mode Figure 3 10 Output power vs impe ance for Fulgurate mode Output Power watts Output Power watts 80 70 60 50 40 30 20 10 0 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 a 500 1000 1500 2000 2500 3000 Load Resistance ohms 3 16 SurgiStat II Service Manual Figure 3 11 Peak voltage vs power setting for Fulgurate mode Figure 3 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 10 15 Output Power Setting watts 20 25 30 35 Generator Setting 25 30 35 40 40 SurgiStat II Service Manual 3 17 suoieoyioads eoiuuo9 Figure 3 13 Output power vs impedance for Bipolar mode Bipolar Curves Output Power watts 501 451 gt 40 35 15 en ON B Em cr 95 500 1000 1500 2000 2500 3000 Load Resistance ohms Figure 3 14 Peak voltage vs power setting for Bipolar mode v 1200 o 1000 S 800 S 600 E 400 a 5 200 e O 0 5 1 5 10 15 20 25 30 o Output Power Setting watts 3 18 SurgiStat II Service Manual Figure 3 15 Output power vs generator settings for Bipolar mode Output Power watts 30 25 20 Generator Setting 20 25 30 SurgiStat
27. ce Manual 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 models 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 Liga
28. ct ground lt 10 pA l all caas al outputs Normal polarity ground open lt 50 LA Reverse polarity ground open lt 50 pA Sink current at high lt 50 LA line all inputs High Freguency RF Leakage Current Bipolar RF leakage lt 39 mArms current Monopolar RF leakage lt 150 MArms current Standards and IEC Classifications The SurgiStat II generator meets all pertinent clauses of the IEC 60601 1 second edition and IEC 60601 2 2 third edition Class I 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 Type CF Equipment IEC 60601 1 Defibrillator Proof The SurgiStat II generator provides a high degree of protection against electric shock particularly regarding allowable leakage 1 currents It is type CF isolated floating output and may be used for procedures involving the heart SurgiStat II Service Manual suoneouioeds eoiuuo9 Liguid Spillage IEC 60601 2 2 Clause 44 3 The SurgiStat II generator enclosure is constructed so that liguid spillage in normal use does not wet electrical insulation or other components which when wetted are likely to adversely affect the safety of the eguipment Electromagnetic Interference When placed on or beneath an activated Valleylab electrosurgical generator the SurgiStat II generator operates without interf
29. d sensing module detects a resistance between 10 and 135 then the SurgiStat II will display the green split plate LED on the front of the unit The pad sensing module constantly monitors the patient contact quality If the impedance changes by a specific amount then the unit displays an alarm and immediately deactivates the RF output power Patient return electrode contact quality is only monitored when a split plate patient return electrode is attached to the patient RF Amplifier Circuit The RF amplifier circuit generates the RF output energy that is delivered to the patient Itis a single ended power amplifier incorporating three power MOSFETs and two toroidal step up transformers The digital PWM circuit and the system logic unit generate the initial RF drive pulse When the RF drive pulse turns the power MOSFETS On current flows from the high voltage supply through one of the output transformers depending on which mode the unit is in through the clamping diodes and then through the MOSFETS to high voltage ground The energy developed by the On time is stored in an LC tank circuit When the MOSFETs are off the energy is delivered to the patient through the output capacitors A longer On time develops more energy in the LC tank circuit therefore more energy is delivered to the patient Monopolar Select Circuit The monopolar select circuit switches the SurgiStat II between each of the four monopolar modes
30. d for use in the electromagnetic environment specified below The customer or the user of the SurgiStat II should ensure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance RF emissions Group 2 The SurgiStat Il uses RF energy only CISPR 11 for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions Class A The SurgiStat Il is suitable for use in CISPR 11 all establishments other than domestic and those directly Harmonic emissions Class A connected to the public low voltage IEC 61000 3 2 power supply network that supplies buildings used for domestic purposes Voltage fluctuations flicker Complies emissions IEC61000 3 3 SurgiStat Il Service Manual 3 7 suoneouioeds eDIUYIJB L Guidance and manufacturers declaration electromagnetic immunity The SurgiStat II is intended for use in the electromagnetic environment specified below The customer or the user of the SurgiStat II should assure that it is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Electrostatic discharge ESD IEC 61000 4 2 6 kV contact 8 kV air 6 kV contact 8 kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the rela
31. dapters are present Inspect all cords and connectors for signs of wear damage and abrasion e Verify that the unit displays no error messages when turned on Service Personnel Safety Hazardous Electrical Output This equipment is for operational use only by a trained licensed physician Bio med technicians must also exercise caution when testing a unit Electric Shock Hazard Connect the generator power cord to a properly grounded receptacle Do not use power plug adapters 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 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 electrosurgical generator should be available for use Do not turn the activation tone down to an inaudible level This activation tone alerts the surgical team when an accessory and the generator is active When using a smoke evacuator in conjunction with the electrosurgical generator place the smoke evacuator
32. des of operation The power control knobs move in increments of one watt Watts Display A 8 B Cut and Coag These large power output displays report the generator s output power setting from 1 to 120 watts in one watt increments at the rated load During operation the numeral output of the display gives the surgeon an indication of available generator power Visual LED Indictors Mode LEDs indicate the mode setting The YELLOW indicators and controls indicate cutting and blending operations A yellow field LED indicates that either a Pure Cut or Blend mode is activated The BLUE indicators and controls indicate desiccation fulguration and bipolar operation The blue field LED indicates that either Desiccate Fulgurate or Bipolar mode is activated The Footswitch Control LED Indicator indicates which mode the footswitch is presently in Monopolar footswitch control allows the user to activate the monopolar mode when using footswitch controlled accessories Bipolar footswitch control allows the user to activate the bipolar mode A return electrode indicator displays which type of patient return electrode is attached to the patient It also has an associated audio alarm that sounds when a patient return electrode is not detected during activation Audible Indicators An activation tone sounds whenever the SurgiStat II Electrosurgical Generator is activated The volume may be adjusted up or down on the rear of
33. e by pressing the Bipolar mode switch on the front panel Note The unit automatically changes to bipolar footswitching when you select the Bipolar mode Verify that the Bipolar mode LED illuminates green 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 Cut pedal returns the unit to an idle state How to Check the Monopolar Mode with Footswitch 1 Select monopolar foot control by pressing the Footswitch Control Selector until the Monopolar Footswitch Control 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 Press the coag pedal on the footswitch Verify that the Desiccate Fulgurate and Bipolar Activation Indicator illuminates and that the system generates the coagulation activation tone While activating the Coag mode rotate the volu
34. er 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 matching footswitch receptacle on the back of the unit Use only a Valleylab footswitch with the SurgiStat II generator Although other types of footswitches may fit they may not be compatible with this electrosurgical generator Use of an incompatible footswitch may cause unexpected output gt Do not connect a patient return electrode to the front of the unit at this time A Turn on the unit by switching the power switch to the On I position gt The correct startup for the unit is a quick flash of all indicators and a series of beeps The unit will return to the last mode and power setting used SurgiStat II Service Manual uone4edo JojeJeuor How to Check the Patient Return Electrode Alarm Function 1 Adjust the power settings for each mode Pure Cut Blend Desiccation Fulguration and Bipolar to 1 W 2 Press the Cut pedal of the footswitch 3 Verify that an alarm sounds for three seconds and then the Patient Return Electrode Sensing Alarm Indicator light illuminates This indicates the patient return electrode is not connected to the unit 4 Verify that adjusting the volume control on the back of the unit while the alarm is sounding cannot change the alarm s sound level How to Check the Bipolar Mode with Footswitch 1 Select the Bipolar mod
35. erence The generator minimizes electromagnetic interference to video eguipment 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 II should not be used adjacent to or stacked with equipment other than specified in the SurgiStat II User Guide and Service Manual If adjacent or stacked use is necessary the SurgiStat II should be observed to verify normal operation in the configuration in which it will be used The SurgiStat Il intentionally applies RF energy for diagnosis or treatment during activation Observe other electronic medical eguipment in the vicinity during the SurgiStat II activation for any possible adverse electromagnetic effects Ensure adequate separation of electronic medical equipment based on observed reactions The use of accessories other than specified in the SurgiStat II User Guide and Service Manual may result in increased emissions or decreased immunity of the SurgiStat Il SurgiStat II Service Manual Guidance and manufacturer s declaration electromagnetic emissions The SurgiStat II is intende
36. esistance 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 freguency 62 5 kHz 2 5 kHz Set resistance 10 O 5 Q to 1350 100 Continuous measurement Once the system establishes the split plate electrode resistance an increase of 40 in resistance or up to 150 whichever is less will cause an alarm A decrease of resistance below 4 Q 2 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 you correct the condition that caused the alarm condition e Activation attempts during an alarm condition result in an audio alarm and the alarm indicator flashes e When the alarm condition is resolved the green single or split plate indicator will illuminate The system measures the return electrode sensing current according to IEC 60601 1 SurgiStat II Service Manual Low Freguency 50 60 Hz Leakage Current Enclosure source lt 300 UA 90V 110V mains voltage current ground open 110V 120V 500 LA 220V 240V mains voltage Source current patient Normal polarity inta
37. f the unit A system clock circuit composed of an oscillator provides the basic operating frequency of 5 MHz The reset circuit provides a single pulse when you turn on the SurgiStat II generator This pulse resets the field programmable gate array to ensure proper operation SurgiStat II Service Manual uoneJedo JO A10BUL SurgiStat II Control Signal Inputs and Outputs The following table lists the important input and output signals From a troubleshooting standpoint the absence and presence of these signals will help you isolate problems Signal Name Description PAD SNS ERROR PAD NSED PAD SED AUD DRV ALM DRV AUX RLY DRV TAP SEL This is the input signal from the pad sense module that informs the system logic that a pad sensing error has occurred When a pad sense error occurs a logic 1 5 VDC is sent to the system logic section This is an input signal from the pad sense module that informs the system logic that a single plate patient return electrode is attached to the front jack strip When the pad sense module senses the presence of a single plate patient return electrode a logic 0 0 VDC is sent to the system logic This is an input signal from the pad sense module that informs the system logic that a split plate patient return electrode is attached to the patient When the pad sense module senses the presence of a split patient return electrode a logic 0 0 VDC is sent to
38. for the patient electrode sense module The 8 VDC circuit supplies power for the RF drive circuit This circuit turns on and off the power MOSFETS for the RF output power The 5 VDC circuit supplies power for the logic system and all of the displays and indicators SurgiStat II Service Manual DC Supply Check Circuit System logic uses the DC supply check circuit to monitor the high voltage DC supply If the voltage increases by 30 the system displays error code E4 and disables the RF output For isolation purposes the high voltage sense voltage is measured from the 15 volt DC power supply Temperature Sensing Circuit System logic uses the temperature sensing circuit to monitor the internal temperature of the unit If the temperature rises above 85 C 185 F the system displays error code E7 and disables the RF output Four Request Activation Sensing Circuits System logic uses the activation request sensing circuit to detect both hand controlled and foot controlled activation requests This circuit consists of a Colpitts Oscillator operating at approximately 50 kHz and a level detection circuit In a nonactivation status the Colpitts oscillator operates at its set operating frequency and presents a sine wave to the level detection circuit The level detection circuit converts the sine wave into a square wave Activation will not occur as long as a square wave is present When a resistance approximately 200 Q or
39. iStat II Service Manual Controls Indicators and Receptacles This section describes the front and rear panels including all controls indicators receptacles the fuse drawer and ports SurgiStat II Service Manual 2 1 Front Panel Figure 2 1 Layout of controls indicators and receptacles on the front panel SurgiStat Il Pure Cut Q Desiccate Q Blend Q Fulgurate 1 Q Bipotar 7 O aco Q9e 2ec3 PATIENT ALARM POWER RG Hl EDO fe ee 2 2 SurgiStat II Service Manual Controls and Indicators Overview Users may control most SurgiStat II functions from the front panel Each control is plainly marked and colored on the front panel for guick reference Volume control and a footswitch connector are on the rear panel Normal operations involve activating the generator with either a front connected handswitch OR a rear connected footswitch The following components are the user interface Power Switch The rocker ON OFF switch on the lower left corner allows turning off the generator when the unit is not in use Membrane Function Switches The front panel overlay contains six membrane function switches sometimes called matrix switches There is a membrane switch dedicated for each operational mode These switches switch the unit between mode settings Power Control Knobs These rotary knobs allow you to select the desired RF power level for all mo
40. ing information The manufacturer s responsibility Returning the generator for service SurgiStat Il Service Manual 8 1 Responsibility of the Manufacturer Valleylab is responsible for the safety reliability performance and service 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 reguirements such as IEC and BSI Equipment use is in accordance with the Valleylab instructions for use For warranty information refer to Section 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 Then clean the generator and ship it to Valleylab for service 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 II Service Manual Service Center Clea
41. ions or metal to metal sparking 1 Check all connections to the generator 2 lt may be necessary to re program the pacemaker Current traveling from active to return electrode during monopolar electrosurgery is passing too close to pacemaker 1 Use bipolar instruments if possible If you must use a monopolar instrument place the patient return electrode as close as possible to the surgical site 2 Make sure the current path from the surgical site to the patient return electrode does not pass through the vicinity of the heart or the site where the pacemaker is implanted 3 Always monitor patients with pacemakers during surgery and keep a defibrillator available 4 Consult the pacemaker manufacturer or hospital 5 Contact the Cardiology Department for further information when use of electrosurgical appliances is planned on patients with cardiac pacemakers Abnormal neuromuscular stimulation stop surgery immediately Metal to metal sparking Check all connections to the generator patient return electrode and active electrodes Can occur during coag Use a lower power setting for the Fulgurate mode or select the Desiccate mode Abnormal 50 60 Hz leakage currents Contact your Valleylab Service Center SurgiStat Il Service Manual 7 9 Gunoouso qnou Kalleylab 7 10 SurgiStat II Service Manual Repair Policy and Procedures This section contains the follow
42. ke 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 Service Manual Board Drawings and Schematics This supplement contains the assembly drawings and schematics for the following printed circuit boards Control board Display board Footswitch board Power Supply RF board SurgiStat II Service Manual Kalleylab A 2 SurgiStat II Service Manual
43. kenn arab iswan most bakyvaoaeaeabakatnek 2 9 Section 3 Technical Specifications Performance CharacteriStiCS h aartreretareraraeaanaeneaanansoaeaoaonsenosososansonounnonsnnounnonsenennuounnnonnnnnnnansnonnanonananoananannnnan 3 2 DULY CY E 3 2 Dimensions and de LE 3 2 Operating B EI E IMS SETTE n k k pan kaz kan l EENEG 3 3 Transport and StOraQO sisi ve esse sise awa ke it n ED EDEL ki On ii ik W erne 3 3 Audio VOU IN CER n ka kai n rain ni 3 3 Patient Return Electrode Sensing esonrncn nnnnn a HRE tn 3 4 Low Frequency 50 60 Hz Leakage Current snoanan n nnnn no RH nn 3 5 High Frequency RF Leakage Current snanan n nnnnnnnn a RH 3 5 Standards and IEC Classificati0nS tarraranrnannnnnnnnu o HR 3 5 Class Equipment IEC 60601 1 c0cnananan nnnnannnnnn nn HEHE 3 5 Type CF Equipment IEC 60601 1 Defibrillator PPOO oseoonon n non nn 3 5 Electromagnetic Interference no RAR RR ER EE EE ENE EHS ERBE BEBE taam stans 3 6 Voltage Transients Emergency Generator Mains Transfer essen 3 6 Electromagnetic Compatibility IEC 60601 1 2 and IEC 60601 2 2 sss 3 6 Output Power Characteristics D uenen nnne 3 11 Maximum Output for Bipolar and Monopolar Modes eese entente 3 11 Output Power e e 3 12 Reference Output Waveforms
44. less is presented to the transformer s secondary winding by a hand control or foot control the sense transformer is essentially shorted The short is felt on the transformer s primary winding causing the Colpitts oscillator to temporarily shut down When the oscillator shuts down the sense signal becomes 5 VDC logic 1 This informs the system logic that a handswitch or footswitch activation reguest has been made If the sguare wave from any of the reguest sense circuits is not present at the system logic when the unit is initially turned on the system displays an error code sounds an alarm and disables RF output Speaker Circuit System logic uses the audio circuit to generate activation tones and alarm tones You can adjust volume for the activation tones from the back panel of the unit Notice You cannot adjust alarm volume up or down SurgiStat II Service Manual uoneJedo JO A10BUL Patient Return Electrode Sensing Circuit The patient return electrode sensing module senses and sends signals to the system logic which displays which type of patient return electrode is attached to the patient When you connect a single plate patient return electrode to the unit the pad sensing module will detect if the resistance is below 5 If it is the SurgiStat II will display the green single plate LED on the front of the unit When you connect a split plate patient return electrode to a patient and the pa
45. llow Cut pedal On this device Footswitch SurgiStat II Service Manual uone4edo JoJeJou91 Kalleylab 5 6 SurgiStat II Service Manual Maintenance This section includes the following information Cleaning the unit Performing periodic inspection Replacing fuses SurgiStat Il Service Manual 6 1 Cleaning 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 Clean the generator after each use Follow the procedures approved by your institution or use a validated infection control procedure 1 Turn off the generator Unplug the power cord from the wall outlet 2 Thoroughly wipe all surfaces of the generator and power cord with a mild Performing Periodic cleaning solution or disinfectant and a damp cloth Inspection Every six months visually inspect the generator 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 Obvious damage to the unit Damage to any receptacle Accumulation of lint or debris in or around the unit SurgiStat II Service Manual Replacing Fuses Fuses for
46. ltage prior to the application of the test level SurgiStat II Service Manual Guidance and manufacturer s declaration electromagnetic immunity The SurgiStat II is intended for use in the electromagnetic environment specified below The customer or the user of the SurgiStat II should assure that it is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Portable and mobile RF communications equipment should be used no closer to any part of the SurgiStat II including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted RF IEC 3 Vrms 3v 61000 4 6 150KHz to 80MHz d 1 2NP Radiated RF 3 V m 3 V m IEC 61000 4 3 80MHz to 2 5GHz d 1 2VP 80MHz to 800MHz d 2 3VP 800MHz to 2 5GHz Where P is 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 NOTE 1 At a 80MHz and 800MH7 the higher frequency range applies NOTE 2 These guidelines may not apply in all situa
47. me control over the full range to verify that the sound is audible throughout the range SurgiStat II Service Manual Operating the Unit How to Check the Monopolar Mode with Handswitch 1 receptacle Connect a handswitching handpiece to the Monopolar Handswitching Activate one at a time the Cut and Coag handswitching controls Verify that each control causes the correct indicator and tone to sound Monopolar Cut Select the desired mode of operation Pure Cut or Blend then select the power settings by rotating the Cut and Blend Power Control Dial Monopolar Coag Select the coag mode of operation Desiccate or Fulgurate then select the power setting by rotating the Coag and Bipolar Power Control Dial Bipolar Select the mode of operation for Bipolar coagulation or fulguration then select the bipolar power settings by rotating the Coag and Bipolar Power Control Dial Activate the generator by pressing the appropriate button on the handswitch or footswitch Notice One footswitch can activate either monopolar or bipolar operation Monopolar Operation To activate Pure Cut or Blend modes Desiccate or Fulgurate modes Press this Yellow button Yellow or Cut pedal Blue button Blue or Coag pedal On this device Handswitching pencil Footswitch Handswitching pencil Footswitch Bipolar Operation To activate Bipolar mode Press this Blue Coag or ye
48. metal patient return electrode plate verify that the cable connections are secure and replace cables with loose connections Turn unit on 3 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 4 If alarm number reappears upon restarting the unit record the number and call the Valleylab Service Center 1 Turn unit off 2 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 3 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 4 If alarm number reappears upon restarting the unit record the number and call the Valleylab Service Center 1 Turn the unit off 2 Allow the unit to cool for 20 minutes 3 Restart the unit Contact your Valleylab Service Center SurgiStat II Service Manual 7 5 Gunoouso qnou Correcting Common Problems If a solution is not readily apparent use the table on the following page to help identify and correct specific malfunctions After you correct the malfunction verify that the generator successfully completes the self test Situation Possible cause Recommended action Generator does not respond when turned on Disconnected power cord
49. n the Generator Electric Shock Hazard Always turn off and unplug the generator before cleaning Do not allow fluids to enter the chassis Do not attempt to 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 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 Ship the Generator Attach a tag to the generator that includes the return authorization number and the information hospital phone number etc listed in Obtain a Return Authorization Number N Besure the generator 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 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 Il Service Manual seJnpeooJg pue AdIjOd JredoH Kalleylab 8 4 SurgiStat II Servi
50. o JO A10BUL Signal Name Description ACT REG HAND B ACT REG FOOT A ACT REG FOOT B This is an input signal from the hand B reguest sense circuit Hand B refers to the Coag button on the handpiece A Colpitts oscillator located on the main board generates this signal When an activation request occurs this oscillator issues a logic 1 5 VDC signal This is an input signal from the foot A request sense circuit foot A refers to the Cut pedal on the footswitch A Colpitts oscillator located on the main board generates this signal When an activation request occurs this oscillator issues a logic 1 5 VDC signal This is an input signal from the foot B request sense circuit foot B refers to the Coag pedal on the footswitch A Colpitts oscillator located on the main board generates this signal When an activation request occurs this oscillator issues a logic 1 5 VDC signal SurgiStat II Service Manual Generator Operation This section covers the following topics Inspecting the generator and accessories Service personnel safety Installation and placement Functional operational checks Operating the unit SurgiStat Il Service Manual 5 1 Inspecting the Generator and Accessories Before each use inspect the unit and all accessories to verify good working order e Inspect for physical damage to the generator and its connections e Verify that the appropriate accessories and a
51. or 2 Disconnect the power cord from the wall receptacle 3 Check the footswitch receptacle on the rear of the unit for obvious signs of obstruction and damage 4 Insert the footswitch connector into the footswitch receptacle Check for a secure fit Use only a Valleylab footswitch with the SurgiStat II generator If the footswitch receptacle is damaged contact your Valleylab Service Center 5 Check the bipolar receptacle on the front of the unit for obstruction or damage 6 Insert a bipolar cable into the bipolar receptacle on the front of the unit Check for a secure fit If the bipolar receptacle is damaged contact your Valleylab Service Center 7 Check the monopolar handpiece receptacle on the front of the unit for obstruction or damage 8 Insert a handswitching pencil into the monopolar handpiece receptacle on the front of the unit Check for a secure fit If the monopolar handpiece receptacle is damaged contact your Vallylab Service Center 9 Check the monopolar foot controlled receptacle on the front of the unit for obstruction or damage 10 Insert a monopolar foot controlled handpiece into the monopolar foot controlled receptacle on the front of the unit Check for a secure fit If the monopolar foot controlled receptacle is damaged Contact your Valleylab Service Center 11 Check the patient return electrode receptacle on the front of the unit for a broken pin or an obstruction 12 Insert a return electrode cable in
52. signal from the digital PWM circuit that controls the pulse width duration for the RF drive This is an input signal that informs the system logic if the 24 pin ribbon cable between the main board and the display board is connected When the cable is connected a logic 0 0 VDC is sent to the system logic section When the cable is damaged not secure or not connected a logic 1 5 VDC is sent to the system logic This is an input signal from the temperature sense circuit that informs the system logic if the internal temperature of the unit is above 85 C 185 F If the internal temperature of the unit is below 85 C 185 F a logic 1 5 VDC is sent to the system logic If the internal temperature of the unit rises above 85 C 185 F a logic 0 0 VDC is sent to the system logic This is an input signal from the high voltage sense circuit that informs the system logic if a high voltage error has occurred If the line voltage is within normal operating parameters a logic 1 5 VDC is sent to the system logic If the line voltage increases by more than 30 a logic 0 0 VDC is sent to the system logic This is an input signal from the hand A reguest sense circuit hand A refers to the Cut button on the handpiece A Colpitts oscillator located on the main board generates this signal When an activation reguest occurs this oscillator issues a logic 1 5 VDC signal SurgiStat II Service Manual uoneJed
53. t 100 MHz e Oscilloscope probes 2 10X and 1000X e Valleylab footswitch e Valleylab handswitching pencil single use or reusable e Standard technician s tool kit e Miscellaneous test leads and cables Troubleshooting the SurgiStat Il If the generator is not functioning properly use the information in this section to perform the following activities e Identify and correct the malfunction e If the system displayed an error code take the appropriate action s to correct the error condition Inspecting the Generator If the SurgiStat II malfunctions check for obvious conditions that may have caused the problem 1 Check the generator for visible signs of physical damage 2 Verify that all accessory cords are properly connected 3 Check the power cord Replace the power cord if you find exposed wires cracks frayed insulation or a damaged connector 4 Open the fuse drawer and inspect the fuse housing and fuses for damage and corrosion 5 Verify that the fuses are firmly seated An internal component malfunction in the generator can damage the fuses 6 You may need to replace the fuses if the generator fails the self test or stops functioning Refer to Fuse Replacement in Section 6 7 2 SurgiStat II Service Manual Inspecting the Receptacles Eguipment reguired Footswitch Bipolar cable Monopolar instruments handswitch and footswitch Return electrode cable Procedure 1 Turn off the generat
54. t be connected to the proper receptacle type In particular bipolar accessories must be connected to the bipolar instrument receptacle only Improper connection may result in inadvertent generator activation or a contact guality monitor alarm Set power levels to the lowest setting before testing an accessory Notice During bipolar electrosurgery do not activate the generator until the forceps have made contact with the patient Product damage may occur SurgiStat II Service Manual Fire Explosion Hazards Explosion Hazard Do not install the generator in the presence of flammable anesthetics gases liquids or objects Fire Hazard Do not place active accessories near or in contact with flammable materials such as gauze or surgical drapes Electrosurgical accessories that are activated or hot from use can cause a fire Use a holster to hold electrosurgical accessories safely away from personnel and flammable materials Fire Hazard Do not use extension cords Fire Hazard For continued protection against fire hazard replace fuses only with fuses of the same type and rating as the original fuse Generator Electric Shock Hazards Do not remove any covers or panels exposing the internal components Refer to a Valleylab representative for service Connect the generator power cord to a properly grounded receptacle Do not use power plug adapters Do not connect a wet power cord to the generator or to the wall receptacle
55. 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 SurgiStat II Service Manual 1 3 101e49ue5 eoi amp unsoJ199 3 1e1s16 ns ouj Do not stack eguipment on top of the generator or place the generator on top of electrical equipment These configurations are unstable and or do not allow adeguate cooling Provide as much distance as possible between the electrosurgical generator and other electronic eguipment such as monitors An activated electrosurgical generator may cause electrical interference with them Do not turn the activation tone down to an inaudible level The activation tone alerts the surgical team when an accessory is active Notice If reguired by local codes connect the generator to the hospital egualization grounding connector with an eguipotential cable Connect the power cord to a wall receptacle having the correct voltage Otherwise product damage may result Active Accessories Electric Shock Hazard Do not connect wet accessories to the generator Electric Shock Hazard Ensure that all accessories and adapters are correctly connected and that no metal is exposed Accessories mus
56. the system logic This is an output signal from the system logic that generates the activation tones for all modes of operation A 1 kHz square wave is generated when the cut or blend mode is activated A 2 kHz square wave is generated when the coagulation fulguration or bipolar mode is activated This signal is used by the audio circuit This is an output signal from the system logic that generates a 2 kHz 1 kHz square wave for activating the alarm siren This signal is used by the audio circuit This is an output signal from the system logic that controls the accessory relay on the back panel This is an output signal from the system logic that controls relays on the main board The relays select which secondary windings will be used from the monopolar output transformer SurgiStat II Service Manual Signal Name Description OUT SEL HAND FOOT SEL RF DRV CON SENS TEMP SEN HV SENS ACT REG HAND A This is an output signal from the system logic that controls relays on the main board They control which output transformer provides the RF output circuit delivered to the patient This is an output signal from the system logic that controls relays on the main board These relays direct which output jack receives the output RF power The output power for monopolar modes is switchable from foot controlled handpiece activation to hand controlled switching pencil activation This is an output
57. tions Electromagnetic propagation is affected by absorption and reflection from structures objects and people a 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 SurgiStat II is used exceeds the applicable RF compliance level above the SurgiStat II should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the SurgiStat II b Over the frequency range 150kHz to 80MHz field strengths should be less than 3V m SurgiStat II Service Manual 3 9 suoneouioeds eoiuuo9 Recommended separation distances between portable and mobile RF communication equipment and the SurgiStat Il Separation distance according to freguency of transmitter m The SurgiStat Il is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The Customer or the user of the SurgiStat II can help prevent electromagnetic interferences by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the SurgiStat II
58. tive humidity should be at least 30 Electrical fast transient burst IEC 61000 4 4 2 kV for power supply lines 1 kV for input output lines 2 KV for power supply lines 1 KV for input output lines Mains power guality should be that of a typical commercial or hospital environment gt 30 dip in Ut for 25 cycles gt 30 dip in Ut for 25 cycles Surge 1 kV differential 1 kV differential Mains power quality should be that of a IEC 61000 4 5 mode mode typical commercial or hospital environment 2 kV common 2 kV common mode mode Voltage dips short 596 Ut lt 5 Ut Mains power quality should be that of a interruptions and voltage gt 95 dip in Ut gt 95 dip in Ut typical commercial or hospital environment variations on power supply for 0 5 cycle for 0 5 cycle If the user of the SurgiStat Il requires input lines o continued operation during power mains IEC 61000 4 11 Be Si Ut 2 Ji Ut interruptions it is recommended that the ko 5 Pi Ge 5 DE SurgiStat II be powered from an SE EE uninterruptible power supply or a battery 7096 Ut 7096 Ut Hz magnetic field IEC 61000 4 8 596 Ut 596 Ut gt 95 dip in Ut gt 95 dip in Ut for 5 sec for 5 sec Power frequency 50 60 3 A m 3 A m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment NOTE Ut is the a c mains vo
59. to the return electrode receptacle and check for a secure fit If the return electrode receptacle on the front of the unit is damaged contact your Valleylab Service Center SurgiStat II Service Manual Gunoouso qnou Understanding Error Codes and Audio Tones Error Code F1 on the Cut Blend display F1 on the Desiccate Fulgurate Bipolar display This is a start activation type of error and is the result of powering On while pressing the pencil activation button F2 Simultaneous activation error F3 Foot activation error E4 High voltage error The SurgiStat II Generator includes automatic continual self diagnostics If the diagnostics detect an error the system displays an error code sounds an audible tone and deactivates the output power Any errors detected will shut down the RF output power Notice Internal firmware self diagnostics continually monitor unit operation to ensure proper and safe performance 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 Description Handswitch or monopolar footswitch cut pedal may be stuck Handswitch or monopolar footswitch coag pedal may be stuck Cut and Coag buttons activated simultaneously pencil or footswitch Monopolar handpiece activated while in Bipolar mode Line voltage error Line voltage
60. too high that is the power supply is 30 above the nominal value Recommended Action 1 Turn off then turn on the generator Do not press buttons or accessory activation devices during the self test 2 lfthe alarm number reappears disconnect all accessories Turn off then turn on the generator again 3 Ifthe problem persists replace the handpiece or footswitch and repeat Step 1 4 lfthe alarm number reappears record the number and contact your Valleylab Service Center The unit does not allow simultaneous activation of the Cut and Coagulation modes Release either the Cut or Coag button on the handpiece or the Cut or Coag pedal on the footswitch Release pressure on the handpiece buttons Use the footswitch to activate bipolar or switch to monopolar mode 1 Turn the unit off 2 Verify that the unit is connected to the correct line voltage 7 4 SurgiStat II Service Manual Error Code E5 Pulse width error E6 Delta check error E7 Temperature error E8 Connector sensing error caused by a sensed open circuit Description Internal pulse width measurement exceeds setting requirements Internal pulse width measurement conflicts with calibrated value Internal temperature of the unit exceeded limit The 24 pin ribbon cable connected between the main board and the display board is either disconnected or damaged Recommended Action 1 Turn unit off 2 If using a
61. tuation which if not avoided may result in minor or moderate injury b Important Indicates an operating tip or Notice maintenance suggestion Indicates a hazard that may result in product damage SurgiStat II Service Manual iii Milite C IEEE ii Safety Precautions when Operating the Generator eese nan iii Applicable Safety Standards EE iii Section 1 The SurgiStat Il Electrosurgical Generator FUNCTION Al DESEFIPLIOM pec D LEE 1 2 Unit DOSCPIPLOM m E aon DE 1 3 Safety Precautions when Testing the Generator ocsenansn nonn o nan 1 3 General Warnings Cautions and Notices o nn 1 3 ee 1 4 Fire Explosion Hazards EEG EDEN bo de e TEE EEN SEN eege 1 5 Generator Electric Shock Hazards o onon n nnnon o HEHE 1 5 SIN BE 1 6 em banana 1 6 Section 2 Controls Indicators and Receptacles Front uiae Biest kk ei oi kt a ra a sed 2 2 Controls and Indicators Overview nonnnannnn nn 2 3 Cutand Blend Goto ISS ae ANNA 2 4 Coaag and Bipolai Conio E Sege e k 2 5 leet e 2 6 Power Switch and ReceptaclesS tirrrn n nannnnenn HEHE 2 7 Rear Panel ossi H 2 8 Symbols on the Front Pan l rete rak sav kana kan kise aka batan ka kondde vi kako ano st vwa an
62. urate Fulgurate Selector When pressed eg Bee Bipolar e 7 Fulgurate mode Bipolar Selector When pressed Coag and Bipolar Power Conirol Dial selects the Bipolar Increases or decreases the Coag or mode Bipolar power output in increments of one watt Bipolar Indicator Illuminates when Bipolar mode is selected SurgiStat II Service Manual 2 5 Sa oe1dodoy pue SIOJEDIPU SJO11U0J Indicators Figure 2 4 Indicators for power return electrodes and footswitch control m m MH MM HH MON HH MH MON W E 2 Bipolar Footswitch Control Indicator and Symbol IIluminates when bipolar foot control is selected Patient Return Electrode Alarm Indicator Illuminates when the system detects a patient return electrode alarm condition O U O POWER PATIENT ALARM Power Indicator Illuminates when the Monopolar Footswitch Control unit is on Indicator and Symbol IIluminates when monopolar foot control is selected Footswitch Conirol 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 llluminates when the system detects a single plate 2 6 SurgiStat II Service Manual Power Switch and Receptacles Figure 2 5 Location of the unit power switch and front panel receptacles cons f man

Surgistat II coagulation Service Manual

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