SurgiStat II Service Manual Aug 2006

Service Manual

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Service Manual

SurgiStat™ II Electrosurgical Generator

Preface This Service Manual and the equipment it describes are for qualified 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. Caution Federal (USA) laws restrict this device to sale by or on the order of a physician.

Equipment covered in this manual

SurgiStat™ II 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

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

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 equipment. 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 Equipment, Type CF CENELEC EN 60601-1-2 FCC Part 15, Class A IEC 60601-1 2nd Edition (1988)

Conventions Used in this Guide Warning Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury.

Caution Indicates a hazardous situation which, if not avoided, may result in minor or moderate injury.

Important Indicates an operating tip or maintenance suggestion.

Notice Indicates a hazard that may result in product damage.

SurgiStat II Service Manual

iii

Preface ..................................................................................................................................................................... ii Safety Precautions when Operating the Generator ......................................................................................... iii Applicable Safety Standards ................................................................................................................................ iii

Section 1. The SurgiStat II Electrosurgical Generator Functional Description ......................................................................................................................................... 1-2 Unit Description .................................................................................................................................................... 1-3 Safety Precautions when Testing the Generator ............................................................................................ 1-3 General Warnings, Cautions, and Notices ............................................................................................. 1-3 Active Accessories ..................................................................................................................................... 1-4 Fire/Explosion Hazards ............................................................................................................................. 1-5 Generator Electric Shock Hazards .......................................................................................................... 1-5 Servicing ...................................................................................................................................................... 1-6 Cleaning ....................................................................................................................................................... 1-6

Section 2. Controls, Indicators, and Receptacles Front Panel............................................................................................................................................................ 2-2 Controls and Indicators Overview ..................................................................................................................... 2-3 Cut and Blend Controls ....................................................................................................................................... 2-4 Coag and Bipolar Controls ................................................................................................................................. 2-5 Indicators ............................................................................................................................................................... 2-6 Power Switch and Receptacles ......................................................................................................................... 2-7 Rear Panel ............................................................................................................................................................ 2-8 Symbols on the Front Panel ............................................................................................................................... 2-9

Section 3. Technical Specifications Performance Characteristics .............................................................................................................................. 3-2 Duty Cycle ................................................................................................................................................... 3-2 Dimensions and Weight ............................................................................................................................ 3-2 Operating Parameters ............................................................................................................................... 3-3 Transport and Storage............................................................................................................................... 3-3 Audio Volume .............................................................................................................................................. 3-3 Patient Return Electrode Sensing ........................................................................................................... 3-4 Low Frequency (50-60 Hz) Leakage Current ........................................................................................ 3-5 High Frequency (RF) Leakage Current .................................................................................................. 3-5 Standards and IEC Classifications .................................................................................................................... 3-5 Class I Equipment (IEC 60601-1) ............................................................................................................ 3-5 Type CF Equipment (IEC 60601-1)/Defibrillator Proof ......................................................................... 3-5 Electromagnetic Interference ................................................................................................................... 3-6 Voltage Transients (Emergency Generator Mains Transfer) .............................................................. 3-6 Electromagnetic Compatibility (IEC 60601-1-2 and IEC 60601-2-2) ................................................. 3-6 Output Power Characteristics .......................................................................................................................... 3-11 Maximum Output for Bipolar and Monopolar Modes .......................................................................... 3-11 Output Power Curves ........................................................................................................................................ 3-12 Reference Output Waveforms ................................................................................................................ 3-20

SurgiStat II Service Manual

Section 4. Theory Of Operation Block Diagram ......................................................................................................................................................4-2 Functional Overview of Key Circuits .................................................................................................................4-2 High Voltage DC Supply ............................................................................................................................4-2 Low Voltage DC Supplies..........................................................................................................................4-2 DC Supply Check Circuit ...........................................................................................................................4-3 Temperature Sensing Circuit ....................................................................................................................4-3 Four Request Activation Sensing Circuits ..............................................................................................4-3 Speaker Circuit............................................................................................................................................4-3 Patient Return Electrode Sensing Circuit ...............................................................................................4-4 RF Amplifier Circuit ....................................................................................................................................4-4 Monopolar Select Circuit ...........................................................................................................................4-4 Monopolar/Bipolar Select Relays .............................................................................................................4-4 Controls and Indicators ..............................................................................................................................4-5 Digital PWM Circuit ....................................................................................................................................4-5 System Logic ........................................................................................................................................................4-5 SurgiStat II Control Signal Inputs and Outputs................................................................................................4-6

Section 5. Generator Operation Inspecting the Generator and Accessories ......................................................................................................5-2 Service Personnel Safety....................................................................................................................................5-2 Installation and Placement..................................................................................................................................5-3 Functional (Operational) Checks .......................................................................................................................5-3 How to Set Up and Start the SurgiStat II Unit ........................................................................................5-3 How to Check the Patient Return Electrode Alarm Function ...............................................................5-4 How to Check the Bipolar Mode (with Footswitch)................................................................................5-4 How to Check the Monopolar Mode (with Footswitch) .........................................................................5-4 How to Check the Monopolar Mode (with Handswitch)........................................................................5-5 Operating the Unit ................................................................................................................................................5-5

Section 6. Maintenance Cleaning the Unit ..................................................................................................................................................6-2 Performing Periodic Inspection ..........................................................................................................................6-2 Replacing Fuses ...................................................................................................................................................6-3

Section 7. Troubleshooting Recommended Equipment for Troubleshooting..............................................................................................7-2 Troubleshooting the SurgiStat II ........................................................................................................................7-2 Inspecting the Generator ...........................................................................................................................7-2 Inspecting the Receptacles .......................................................................................................................7-3 Understanding Error Codes and Audio Tones ................................................................................................7-4 Correcting Common Problems ...........................................................................................................................7-6

SurgiStat II Service Manual

Section 8. Repair Policy and Procedures Responsibility of the Manufacturer .................................................................................................................... 8-2 Returning the Generator for Service ................................................................................................................. 8-2 Obtain a Return Authorization Number................................................................................................... 8-2 Clean the Generator .................................................................................................................................. 8-3 Ship the Generator ..................................................................................................................................... 8-3 Service Center ...................................................................................................................................................... 8-3

Section 9. Warranty Section A. Board Drawings and Schematics Main Board ........................................................................................................................................................... A-3 Power Supply....................................................................................................................................................... A-4 RF Amplifier Circuit ............................................................................................................................................. A-5 Request Sense Circuit Hand A ......................................................................................................................... A-6 Request Sense Circuit Hand B ......................................................................................................................... A-7 Request Sense Circuit Foot A........................................................................................................................... A-8 Request Sense Circuit Foot B........................................................................................................................... A-9 Display Board .................................................................................................................................................... A-10 Display Logic ......................................................................................................................................................A-11 Monopolar Select Circuit .................................................................................................................................. A-12 Main Printed Circuit Board............................................................................................................................... A-13 Display Printed Circuit Boards ........................................................................................................................ A-14 Relay Printed Circuit Board ............................................................................................................................. A-15 Front Panel Assembly ...................................................................................................................................... A-16 Back Panel Assembly....................................................................................................................................... A-17 Final Assembly .................................................................................................................................................. A-18

SurgiStat II Service Manual

SECTION

The SurgiStat II Electrosurgical Generator 1

This section includes the following information:

• Key features • Components and accessories • Safety

Caution 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.

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Functional Description The SurgiStat II is a multipurpose electrosurgical generator for use in physician’s 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

Up to 120 watts (W) of Pure Cut @ 500 ohms (Ω). Up to 90 W of Blend @ 800 Ω. Up to 80 W of Desiccation @ 1000 Ω. Up to 40 W of Fulguration @ 1000 Ω. Up to 30 W of Bipolar @ 200 Ω.

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 broader tissue surface areas.

Return Electrode Monitoring System

The unit incorporates a return electrode contact quality monitoring system (RECQMS). 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.

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Memory

The generator automatically powers up to the last modes selected, and previously set power settings.

Isolated (Floating) Radio Frequency (RF) Output

This minimizes the potential of alternate site burns.

SurgiStat II Service Manual

These connectors accept the latest monopolar and bipolar instruments.

Self Diagnostics

These diagnostics continually monitor the unit to ensure proper performance.

The SurgiStat II Electrosurgical Generator

Standard Front Panel Connectors

Whenever they detect a problem, medical personnel receive audible and visual alarm responses, and the output is suspended until the alarm condition is cleared.

Unit Description 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.

•

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 Warning 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.

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Caution 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 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 required by local codes, connect the generator to the hospital equalization (grounding) connector with an equipotential cable. Connect the power cord to a wall receptacle having the correct voltage. Otherwise, product damage may result.

Active Accessories Warning 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.

Caution Accessories must 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 quality 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.

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SurgiStat II Service Manual

Warning 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 Warning 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. 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.

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The SurgiStat II Electrosurgical Generator

Fire/Explosion Hazards

Servicing Caution 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.

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SurgiStat II Service Manual

SECTION

Controls, Indicators, and Receptacles 2

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

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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 quick 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. 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 modes of operation. The power control knobs move in increments of one watt.

Watts Display A & 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 the unit. An alarm sounds during all alarm conditions. You cannot adjust the volume of this alarm.

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Controls, Indicators, and Receptacles

Power Switch

Cut and Blend Controls Figure 2-2.Controls for the Cut and Blend modes

Cut Indicator Illuminates when Pure Cut mode is selected. Cut Selector When pressed, selects the Pure Cut mode.

Blend Selector When pressed, selects the Blend mode. Blend Indicator Illuminates when Blend mode is selected.

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Cut and Blend Power Display (watts) Indicates the power set for the Pure Cut or Blend mode. Cut and Blend Activation Indicator Illuminates when either Pure Cut or Blend mode is activated.

Cut and Blend Power Control Dial Increases or decreases the Cut or Blend power output in increments of one watt.

SurgiStat II Service Manual

Coag and Bipolar Controls Figure 2-3.Controls for the Desiccate, Fulgurate, and Bipolar modes

Coag and Bipolar Activation Indicator Illuminates when Desiccate, Fulgurate, or Bipolar modes are activated.

Desiccate Selector When pressed, selects the Desiccate mode.

Fulgurate Indicator Illuminates when Fulgurate mode is selected.

Fulgurate Selector When pressed, selects the Fulgurate mode.

Bipolar Selector When pressed, selects the Bipolar mode. Bipolar Indicator Illuminates when Bipolar mode is selected.

SurgiStat II Service Manual

Coag and Bipolar Power Control Dial Increases or decreases the Coag or Bipolar power output in increments of one watt.

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Controls, Indicators, and Receptacles

Desiccate Indicator Illuminates when Desiccate mode is selected.

Coag and Bipolar Power Display (watts) Indicates the power set for any Coag or Bipolar mode.

Indicators Figure 2-4.Indicators for power, return electrodes, and footswitch control

Bipolar Footswitch Control Indicator and Symbol Illuminates when bipolar foot control is selected. Patient Return Electrode Alarm Indicator Illuminates when the system detects a patient return electrode alarm condition.

Power Indicator Illuminates when the unit is on.

Split-Plate Patient Return Electrode Indicator Illuminates when the system detects a split-plate.

2-6

Monopolar Footswitch Control Indicator and Symbol Illuminates when monopolar foot Footswitch control is selected. Control Selector When pressed, Single-Plate Patient Return switches between Electrode Indicator monopolar and Illuminates when the system bipolar foot control. detects a single-plate.

SurgiStat II Service Manual

Power Switch and Receptacles Figure 2-5.Location of the unit power switch and front panel receptacles

Controls, Indicators, and Receptacles

Bipolar Receptacle Accepts standard cables for bipolar handpieces.

Power On/Off Switch Turns the unit on or off.

Patient Return Electrode Receptacle Accepts a standard patient return electrode plug.

SurgiStat II Service Manual

Monopolar Handswitching Receptacle Accepts standard three-pin handpieces. Connect handswitching accessories. Monopolar Footswitching Receptacle Accepts cables or adapters equipped with standard (Bovie #12) active plugs. Connect footswitching accessories.

2-7

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.

Footswitch Receptacle Accepts the E6008 or E6008B monopolar footswitch. Use the monopolar footswitch for both monopolar and bipolar activation. Use only a Valleylab monopolar footswitch with a SurgiStat II generator. Use of an incompatible footswith may cause unexpected output.

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Volume Control Controls the volume of the audible tones produced during normal unit activation. To increase volume, rotate the knob clockwise.

Power Cable Receptacle and Fuse Holder Connects a hospital grade power cord to supply AC mains power to the unit.

Serial Number Label Specifies the unit model number, serial number, nominal line voltage, frequency, current, and power consumption.

SurgiStat II Service Manual

Symbols on the Front Panel Symbols

Description

Cut Controls

Cut mode

Blend mode

Controls, Indicators, and Receptacles

Coag Controls

Desiccate mode

Fulgurate mode

Bipolar mode

Indicators

Single-plate patient return electrode

Split-plate patient return electrode

Monopolar footswitch control

Footswitch (on the selector button)

Bipolar footswitch control

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2-9

Symbols

Description

Power Switch and Handpiece Connectors

Read instructions before use

Type CF equipment

Patient return electrode

RF isolated – patient connections are isolated from earth at high frequency

Caution – high voltage

Monopolar output

Bipolar output

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SurgiStat II Service Manual

Symbols on the Rear Panel

Symbols on the Rear Panel Symbols

Description

Equipotential ground stud

Nonionizing radiation

Volume control

Controls, Indicators, and Receptacles

Danger Explosion risk if used with flammable anesthetics

Monopolar footswitch

Read instructions before use

SurgiStat II Service Manual

2-11

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SurgiStat II Service Manual

SECTION

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.

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3-1

Performance Characteristics Input Power Surg II-20 110–120 Volt

Surg II-8 220–240 Volt

Surg II-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): 5060 Hz

Mains line frequency range (nominal): 50-60 Hz

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 Ω 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

3-2

Width

26 cm (10.25 in.)

Depth

30.5 cm (12 in.)

Height

15.2 cm (6 in.)

Weight

< 6.5 kg (< 14 lbs)

SurgiStat II Service Manual

Operating Parameters Ambient temperature range

10° to 40° C (50° to 104° F)

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 range

-34° to 65° C (-29° to 149° F)

Relative humidity

0% to 75%, noncondensing

Atmospheric pressure

500 to 1060 millibars

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

SurgiStat II Service Manual

Continuous while the generator is activated

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Technical Specifications

Audio Volume

Alarm Tone Volume (not adjustable)

70 dBA ± 5 dBA

Frequency

2 kHz for 1 second, then 1 kHz for 1 second

Duration

4 seconds

Patient Return Electrode Sensing Single-Plate

Measurement current: < 100 µA Measurement frequency: 62.5 kHz ± 2.5 kHz Set resistance: 0 Ω to 5 Ω ± 3 Ω Continuous measurement: Once the system establishes the single-plate electrode resistance, an increase of 20 Ω ± 5 Ω in resistance will cause an alarm. When the alarm condition exists, the system deactivates output power.

Split-Plate

Measurement current: < 100 µA Measurement frequency: 62.5 kHz ± 2.5 kHz Set resistance: 10 Ω ± 5 Ω to 135 Ω ± 10 Ω Continuous measurement: Once the system establishes the split-plate electrode resistance, an increase of 40% in resistance or up to 150 Ω (whichever is less) will cause an alarm. A decrease of resistance below 4 Ω ± 2 Ω 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:

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•

When a fault condition occurs, the alarm indicator flashes red, an alarm tone sounds, and the system disables output power.

•

The red LED alarm indicator remains illuminated until you correct the condition that caused the alarm condition.

•

Activation attempts during an alarm condition result in an audio alarm and the alarm indicator flashes.

•

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 Frequency (50-60 Hz) Leakage Current Enclosure source current, ground open

Source current, patient leads, all outputs

< 300 µA

90V-110V mains voltage 110V-120V

< 500 µA

220V-240V mains voltage

Normal polarity, intact ground: < 10 µA Normal polarity, ground open: < 50 µA Reverse polarity, ground open: < 50 µA

Sink current at high line, all inputs

< 50 µA

High Frequency (RF) Leakage Current Bipolar RF leakage current

< 39 mArms

Monopolar RF leakage current

< 150 mArms

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 currents. It is type CF isolated (floating) output and may be used for procedures involving the heart.

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Technical Specifications

Standards and IEC Classifications

Liquid Spillage (IEC 60601-2-2 Clause 44.3) The SurgiStat II 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 generator, 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 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 II intentionally applies RF energy for diagnosis or treatment during activation. Observe other electronic medical equipment 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 II.

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SurgiStat II Service Manual

Guidance and manufacturer's declaration - electromagnetic emissions The SurgiStat II is intended 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 CISPR 11

Group 2

The SurgiStat II uses RF energy only 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 CISPR 11

Class A

Harmonic emissions IEC 61000-3-2

Class A

The SurgiStat II is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Voltage fluctuations/ flicker emissions IEC61000-3-3

Complies

Technical Specifications

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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

Electrostatic discharge (ESD) IEC 61000-4-2

+/-6 kV contact

+/-8 kV air

Electrical fast transient/ burst IEC 61000-4-4

+/-2 kV for power supply lines

+/-1 kV for input/ output lines

+/-1 kV differential mode

+/-2 kV common mode

<5% Ut (>95% dip in Ut) for 0,5 cycle

40% Ut (>60% dip in Ut) for 5 cycles

70% Ut (>30% dip in Ut) for 25 cycles

<5% Ut (>95% dip in Ut) for 5 sec

3 A/m

Surge IEC 61000-4-5

Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

Power frequency (50/60 Hz) magnetic field IEC 61000-4-8

Electromagnetic environment guidance Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Mains power quality should be that of a typical commercial or hospital environment.

Mains power quality should be that of a typical commercial or hospital environment.

Mains power quality should be that of a typical commercial or hospital environment. If the user of the SurgiStat II requires continued operation during power mains interruptions, it is recommended that the SurgiStat II be powered from an uninterruptible power supply or a battery.

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

NOTE: Ut is the a.c. mains voltage prior to the application of the test level.

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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.

Conducted RF IEC 61000-4-6

3 Vrms 150KHz to 80MHz

Radiated RF IEC 61000-4-3

3 V/m 80MHz to 2.5GHz

3 V/m

Recommended separation distance d=1.2√P d=1.2√P 80MHz to 800MHz d=2.3√P 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).

Interference may occur in the vicinity of equipment marked with the following symbol:

NOTE 1 At a 80MHz and 800MHz, 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. 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.

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Technical Specifications

Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than the compliance level in each frequency range

Recommended separation distances between portable and mobile RF communication equipment and the SurgiStat II The SurgiStat II 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 as recommended below, according to the maximum output power of the communications equipment. Separation distance according to frequency of transmitter (m) Rated maximum output power of transmitter (W)

150 kHz to 80MHz d=1.2√P

80MHz to 800MHz d=1.2√P

800MHz to 2.5GHz d=2.3√P

0.01

0.12 m

0.23 m

0.1

0.38 m

0.73 m

1.2 m

2.3 m

3.8 m

7.3 m

100

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.

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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.

Output Power

Output Frequency

Repetition Rate

Vp-p max

Crest Factor* (Rated Load)

Cut

120 W @ 500 Ω

357 kHz ± 50 kHz

N/A

2.5 kV

2.9 ± 20%

Blend

90 W @ 800 Ω

357 kHz ± 50 kHz

30 kHz ± 5 kHz

3.5 kV

3.3 ± 20%

Desiccate

80 W @ 1000 Ω

475 kHz ± 50 kHz

57 kHz ± 5 kHz

4.5 kV

5.5 ± 20%

Fulgurate

40 W @ 1000 Ω

410 kHz ± 50 kHz

25 kHz ± 5 kHz

6.5 kV

7.7 ± 20%

Bipolar

30 W @ 200 Ω

520 kHz ± 50 kHz

32 kHz ± 5 kHz

2.0 kV

6.9 ± 20%

Mode

* An indication of a waveform’s ability to coagulate bleeders without a cutting effect

Technical Specifications

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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.

Output Power (watts)

Figure 3-1 . Output power vs. impedance for Pure Cut mode

Load Resistance (ohms)

Open Circuit Peak Voltage (volts)

Figure 3-2. Peak voltage vs. power setting for Pure Cut mode

Output Power Setting (watts)

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Figure 3-3. Output power vs. generator settings for Pure Cut mode 130 120 110

Output Power (watts)

100 90 80 70 60 50 40 30 20 10 0 0

100 105 110 115 120

Generator Setting

Figure 3-4. Output power vs. impedance for Blend mode

Output Power (watts)

Technical Specifications

Load Resistance (ohms)

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Open Circuit Peak Voltage (volts)

Figure 3-5. Peak voltage vs. power setting for Blend mode

Output Power Setting (watts)

Figure 3-6. Output power vs. generator settings for Blend mode 100 90

Output Power (watts)

80 70 60 50 40 30 20 10 0

Generator Setting

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Monopolar Coag Curves These measurements were taken using short (< 0.5 meter) leads.

Output Power (watts)

Figure 3-7. Output power vs. impedance for Desiccate mode

Load Resistance (ohms)

SurgiStat II Service Manual

Technical Specifications

Open Circuit Peak Voltage (volts)

Figure 3-8. Peak voltage vs. power setting for Desiccate mode

Output Power Setting (watts)

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Figure 3-9. Output power vs. generator settings for Desiccate mode 80 70

Output Power (watts)

60 50 40 30 20 10 0 0

10 15 20 25 30 35 40 45 50 55 60 65 70 75 80

Generator Setting

Output Power (watts)

Figure 3-10. Output power vs. impedance for Fulgurate mode

Load Resistance (ohms)

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Open Circuit Peak Voltage (volts)

Figure 3-11. Peak voltage vs. power setting for Fulgurate mode

Output Power Setting (watts)

Figure 3-12. Output power vs. generator settings for Fulgurate mode 40 35

Technical Specifications

Output Power (watts)

20 15 10 5 0 0

Generator Setting

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Bipolar Curves

Output Power (watts)

Figure 3-13. Output power vs. impedance for Bipolar mode

Load Resistance (ohms)

Open Circuit Peak Voltage (volts)

Figure 3-14. Peak voltage vs. power setting for Bipolar mode

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Output Power Setting (watts)

SurgiStat II Service Manual

Figure 3-15. Output power vs. generator settings for Bipolar mode 30

Output Power (watts)

25 20 15 10 5 0 0

Generator Setting

Technical Specifications

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Reference Output Waveforms The following figures are the output waveforms as viewed on an oscilloscope. Figure 3-16. Pure Cut mode waveform

Figure 3-17. Blend mode waveform

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Figure 3-18. Desiccation mode waveform

Figure 3-19. Fulguration mode waveform

Technical Specifications

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Figure 3-20. Bipolar mode waveform

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SECTION

Theory Of Operation 1

This section includes the following information: • Block diagram • Functional overview of key circuits • System logic • Control signal inputs and outputs

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Block Diagram Figure 4-1 . Functional block diagram of the SurgiStat II system

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.

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•

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 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 15volt 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 handcontrolled 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 Ω or 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 request has been made. If the square wave (from any of the request 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

Notice You cannot adjust alarm volume up or down.

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Theory Of Operation

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.

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 Ω. 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 pad sensing module detects a resistance between 10 and 135 Ω, 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. Warning 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. It is 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. 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.

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Valleylab SurgiStat

SurgiStat II Service Manual Aug 2006