SurgiStat II Service Manual Aug 2006.pdf
Page 1
Service Manual
SurgiStat™ II
Electrosurgical Generator
Page 2
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.
ii
SurgiStat II Service Manual
Page 3
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
Page 4
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
iv
SurgiStat II Service Manual
Page 5
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
v
Page 6
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
vi
SurgiStat II Service Manual
Page 7
SECTION
1
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.
SurgiStat II Service Manual
1-1
Page 8
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.
1-2
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
Page 9
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.
SurgiStat II Service Manual
1-3
Page 10
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.
1-4
SurgiStat II Service Manual
Page 11
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.
SurgiStat II Service Manual
1-5
The SurgiStat II
Electrosurgical Generator
Fire/Explosion Hazards
Page 12
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.
1-6
SurgiStat II Service Manual
Page 13
SECTION
2
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
Page 14
Front Panel
Figure 2-1.Layout of controls,
indicators, and receptacles on
the front panel
2-2
SurgiStat II Service Manual
Page 15
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.
SurgiStat II Service Manual
2-3
Controls, Indicators,
and Receptacles
Power Switch
Page 16
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.
2-4
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
Page 17
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.
2-5
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.
Page 18
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
Page 19
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
Page 20
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.
2-8
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
Page 21
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
SurgiStat II Service Manual
2-9
Page 22
Symbols
Description
Power Switch and Handpiece Connectors
Read instructions before use
Type CF equipment
Patient return electrode
F
RF isolated – patient connections are isolated from earth at
high frequency
Caution – high voltage
Monopolar output
Bipolar output
2-10
SurgiStat II Service Manual
Page 23
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
Page 24
2-12
SurgiStat II Service Manual
Page 25
SECTION
3
Technical Specifications
3
All specifications are nominal and subject to change without notice.
A specification referred to as “typical” is within ± 20% of a stated
value at room temperature (25° C / 77° F) and a nominal input
power voltage.
SurgiStat II Service Manual
3-1