Valleylab Surgistat II User manual

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

Tyco Healthcare UK Ltd.

Gosport, PO13 0AS, UK

Made in USA

Printed in USA

©2006 Valleylab All rights reserved.

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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

Important

Indicates an operating tip or maintenance suggestion.

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

Notice

Indicates a hazard that may result in product damage.

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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

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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

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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

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SECTION 1

The SurgiStat II

Electrosurgical Generator

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 provides precise control
Desiccation and Fulguration	of bleeding in localized areas.
	Fulguration provides greater control of
	bleeding in highly vascular tissue over
	broader tissue surface areas.
Return Electrode Monitoring	The unit incorporates a return
System	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.
Memory	The generator automatically powers
	up to the last modes selected, and
	previously set power settings.
Isolated (Floating) Radio	This minimizes the potential of
Frequency (RF) Output	alternate site burns.

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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.

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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Fire/Explosion Hazards

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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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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SECTION 2

Controls, Indicators,

and Receptacles

This section describes the front and rear panels, including all controls, indicators, receptacles, the fuse drawer, and ports.

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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.

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	The front panel overlay contains six membrane function
Function Switches	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	These rotary knobs allow you to select the desired RF
Knobs	power level for all modes of operation. The power
	control knobs move in increments of one watt.
Watts Display A &	These large power output displays report the
B (Cut and Coag)	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.

Indicators, Controls, Receptacles and

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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.

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.

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Coag and Bipolar Controls

Figure 2-3.Controls for the

Desiccate, Fulgurate, and

Bipolar modes

Desiccate Indicator

Illuminates when Desiccate mode is selected.

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.

Coag and Bipolar		Coag and Bipolar		Receptaclesand	Indicators,Controls,
Power Display (watts)		Activation Indicator
Indicates the power set		Illuminates when Desiccate,
for any Coag or Bipolar		Fulgurate, or Bipolar modes
mode.		are activated.

Coag and Bipolar Power Control Dial

Increases or decreases the Coag or Bipolar power output in increments of one watt.

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

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Power Switch and Receptacles

Figure 2-5.Location of the unit power switch and front panel 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.

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.

Indicators, Controls, Receptacles and

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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.

Volume Control

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

Serial Number Label

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

Power Cable Receptacle and Fuse Holder

Connects a hospital grade power cord to supply AC mains power to the unit.

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Symbols on the Front Panel

Symbols		Description
Cut Controls
		Cut mode
		Blend mode

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

Indicators, Controls, Receptacles and

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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

Fhigh frequency

Caution – high voltage

Monopolar output

Bipolar output

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Symbols on the Rear Panel

Symbols on the Rear Panel

Symbols Description

Equipotential ground stud

Nonionizing radiation

Volume control

Danger

Explosion risk if used with flammable anesthetics

Monopolar footswitch

Read instructions before use

Indicators, Controls, Receptacles and

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SECTION 3

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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