Valleylab SurgiStat II-20 User manual

User’s Guide
SurgiStat™II-20
Electrosurgical Generator

ii SurgiStat II-20 User’s Guide
This manual and the equipment it describes are for use only by qualified medical
professionals trained in the particular technique and surgical procedure to be
performed. It is intended as a guide for using the Valleylab SurgiStat™II-20
electrosurgical generator only. Additional technical information is available in the
SurgiStat™II Electrosurgical Generator Service Manual.
Equipment covered in this manual
Surg II-20 electrosurgical generator
Valleylab Part Number 1003623
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.
Caution
Federal (USA) laws restrict this device to sale by or on the order of a physician.

SurgiStat II-20 User’s Guide iii
Important
Conventions Used in this Guide
Indicates an operating tip or
maintenance suggestion.
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.
Notice
Indicates a hazard which may result in product damage.

iv SurgiStat II-20 User’s Guide
Table of Contents
Conventions Used in this Guide iii
List of Figures vii
Chapter 1. Introducing the SurgiStat II Electrosurgical Generator
Key Features 1-2
Components and Accessories 1-3
Safety 1-3
Warnings 1-4
Cautions 1-6
Chapter 2. Controls, Indicators, and Receptacles
Front Panel 2-2
Cut and Blend Controls 2-3
Coag and Bipolar Controls 2-4
Indicators 2-5
Power Switch and Receptacles 2-6
Rear Panel 2-7
Symbols on the Front Panel 2-8
Symbols on the Rear Panel 2-9
Chapter 3. Getting Started
Initial Inspection 3-2
Installation 3-2
Function Checks 3-2
Setting Up the Unit 3-2
Checking the Patient Return Electrode Alarm 3-3
Confirming Modes 3-3
Checking Bipolar Mode (with Footswitch) 3-3
Checking Monopolar Mode (with Footswitch) 3-3
Checking Monopolar Mode (with Handswitch) 3-4
Performance Checks 3-4
Chapter 4. Using the SurgiStat II
Inspecting the Generator and Accessories 4-2
Setup Safety 4-2
Setting Up 4-4
Preparing for Monopolar Surgery 4-4
Applying the Patient Return Electrode 4-4
Connecting Accessories 4-5
Preparing for Bipolar Surgery 4-5
Activation Safety 4-6
Activating the Unit 4-8

SurgiStat II-20 User’s Guide v
Chapter 5. Maintaining the SurgiStat II
Cleaning 5-2
Periodic Inspection 5-2
Fuse Replacement 5-3
Chapter 6. Troubleshooting
General Troubleshooting Guidelines 6-2
Correcting Malfunctions 6-2
Chapter 7. Repair Policy and Procedures
Responsibility of the Manufacturer 7-2
Returning the Generator for Service 7-2
Obtain a Return Authorization Number 7-2
Clean the Generator 7-3
Ship the Generator 7-3
Chapter 8. Technical Specifications
Performance Characteristics 8-2
Input Power 8-2
Duty Cycle 8-2
Dimensions and Weight 8-2
Operating Parameters 8-3
Transport and Storage 8-3
Audio Volume 8-3
Patient Return Electrode Sensing 8-4
Low Frequency (50–60 Hz) Leakage Current 8-5
High Frequency (RF) Leakage Current 8-5
Standards and IEC Classifications 8-5
Class I Equipment (IEC 60601-1) 8-5
Type CF Equipment (IEC 60601-1)/Defibrillator Proof 8-6
Liquid Spillage (IEC 60601-2-2 Clause 44.3) 8-6
Electromagnetic Interference 8-6
Voltage Transients (Emergency Generator Mains Transfer) 8-6
Electromagnetic Compatibility (IEC 60601-1-2 and IEC 60601-2-2) 8-6
Output Characteristics 8-7
Maximum Output for Bipolar and Monopolar Modes 8-7
Output Power Curves 8-8
Monopolar Cut Curves 8-8
Monopolar Coag Curves 8-11
Bipolar Curves 8-14
Chapter 9. Warranty

SurgiStat II-20 User’s Guide vii
List of Figures
Figure 2-1. Layout of controls, indicators, and receptacles on the front panel 2-2
Figure 2-2. Controls for the Cut and Blend modes 2-3
Figure 2-3. Controls for the Desiccate, Fulgurate, and Bipolar modes 2-4
Figure 2-4. Indicators for power, return electrodes, and footswitch control 2-5
Figure 2-5. Location of the unit power switch and front panel receptacles 2-6
Figure 2-6. Layout of connectors and controls on the rear panel 2-7
Figure 8-1. Output power vs. impedance for Pure Cut mode 8-8
Figure 8-2. Peak voltage vs. power setting for Pure Cut mode 8-8
Figure 8-3. Output power vs. generator settings for Pure Cut mode 8-9
Figure 8-4. Output power vs. impedance for Blend mode 8-9
Figure 8-5. Peak voltage vs. power setting for Blend mode 8-10
Figure 8-6. Output power vs. generator settings for Blend mode 8-10
Figure 8-7. Output power vs. impedance for Desiccate mode 8-11
Figure 8-8. Peak voltage vs. power setting for Desiccate mode 8-11
Figure 8-9. Output power vs. generator settings for Desiccate mode 8-12
Figure 8-10. Output power vs. impedance for Fulgurate mode 8-12
Figure 8-11. Peak voltage vs. power setting for Fulgurate mode 8-13
Figure 8-12. Output power vs. generator settings for Fulgurate mode 8-13
Figure 8-13. Output power vs. impedance for Bipolar mode 8-14
Figure 8-14. Peak voltage vs. power setting for Bipolar mode 8-14
Figure 8-15. Output power vs. generator settings for Bipolar mode 8-15

SurgiStat II-20 User’s Guide 1-1
1
1Introducing 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.
Chapter

Key Features
1-2 SurgiStat II-20 User’s Guide
Important
Key Features
The SurgiStat II electrosurgical generator includes the latest technology. This unit
offers unsurpassed performance, flexibility, reliability, and convenience.
It includes the following features:
•Two levels of coagulation: desiccation and fulguration Desiccation
provides precise control of bleeding in localized areas. Fulguration provides
greater control of bleeding in highly vascular tissue over broad surface areas.
TheRECQMSsystemrequires
that you use a split-plate
patient return electrode.
•Return electrode sensing and contact quality monitoring The SurgiStat II
incorporates a return electrode contact quality monitoring system
(RECQMS). This system determines the type of patient return electrode:
single or split-plate. The system also continually monitors the contact quality
between the patient and the split-plate return electrode. This feature is
designed to eliminate patient burns at the return electrode site.
•Memory The unit automatically powers up to the most recently used modes
and power settings.
•Power adjustment during activation You can change the power setting
while you activate the unit. If you change the power setting for the mode you
are using, your change affects the power you are applying to the patient. You
can increase or decrease power as much as three watts per second while
activating the unit.
•Isolated RF output This minimizes the potential of alternate site burns.
•Standard connectors These connectors accept the latest monopolar and
bipolar instruments.
•Self diagnostics These diagnostics continually monitor the unit to ensure
proper performance.
Valleylab electrosurgical generators, patient return electrodes, and active
accessories are designed to work as a system. Valleylab offers a selection of
patient return electrodes and electrosurgical instruments that are fully compatible
with this generator. When considering other manufacturer’s patient return
electrodes and/or active accessories, customers should seek detailed user
instructions and warning information from the manufacturer.

Components and Accessories
Introducing the SurgiStat II
Electrosurgical Generator
SurgiStat II-20 User’s Guide 1-3
Components and Accessories
You should receive the following components:
• SurgiStat II electrosurgical generator
• Hospital grade power cord
• User’s guide
• Service manual
The following items are optional accessories that you can use with the SurgiStat II
generator:
• E6008 – Monopolar footswitch 4.6 m (15 ft) cord
• E6008B – Monopolar footswitch 4.6 m (15 ft) cord
• E8007 – Compact mounting cart
• E8002 – Mounting stand
Safety
The safe and effective use of electrosurgery depends to a large degree on factors
solely under the control of the operator. There is no substitute for a properly
trained and vigilant medical staff. It is important that they read, understand, and
follow the operating instructions supplied with this electrosurgical equipment.
Physicians have used electrosurgical equipment safely in numerous procedures.
Before starting any surgical procedure, the surgeon should be familiar with the
medical literature, complications, and hazards of using electrosurgery in that
procedure.
To promote the safe use of the SurgiStat II electrosurgical generator, this section
presents the warnings and cautions that appear throughout this user’s guide. So
that you can operate this equipment with maximum safety, it is important that you
read, understand, and follow the instructions in these warnings and cautions. It is
also important that you read, understand, and follow the instructions for use in this
user’s guide.

Safety
1-4 SurgiStat II-20 User’s Guide
Warnings
Warning
Hazardous Electrical Output This equipment is for use only by trained,
licensed physicians.
Danger: Fire/Explosion Hazard Do not use the SurgiStat II electrosurgical
generator in the presence of flammable anesthetics.
Fire/Explosion Hazard The following substances will contribute to increased
fire and explosion hazards in the operating room:
• Flammable substances (such as alcohol based skin prepping agents and
tinctures)
• Naturally occurring flammable gases that may accumulate in body cavities
such as the bowel
• Oxygen enriched atmospheres
• Oxidizing agents (such as nitrous oxide [N2O] atmospheres)
The sparking and heating associated with electrosurgery can provide an ignition
source. Observe fire precautions at all times. When using electrosurgery in the
same room with any of these substances or gases, prevent their accumulation or
pooling under surgical drapes, or within the area where electrosurgery is
performed.
Electric Shock Hazard Connect the power cord to a properly polarized and
grounded power source with the frequency and voltage characteristics that match
those listed on the back of the unit. Do not use power plug adapters.
Electric Shock Hazard Always turn off and unplug the generator before
cleaning.
Fire Hazard Do not use extension cords.
Patient Safety Use the generator only if the self-test has been completed as
described. Otherwise, inaccurate power outputs may result.
Failure of the high frequency electrosurgical equipment could result in an
unintended increase of output power.
The instrument receptacles on this generator are designed to accept only one
instrument at a time. Do not attempt to connect more than one instrument at a
time into a given receptacle. Doing so will cause simultaneous activation of the
instruments.
Use the lowest output setting necessary to achieve the desired surgical effect.
Use the active electrode only for the minimum time necessary in order to reduce
the possibility of unintended burn injury. Pediatric applications and/or procedures
performed on small anatomic structures may require reduced power settings. The
higher the current flow, and the longer the current is applied, the greater the
possibility of unintended thermal damage to tissue, especially during use on
small structures.

Safety
Introducing the SurgiStat II
Electrosurgical Generator
SurgiStat II-20 User’s Guide 1-5
Use electrosurgery with caution in the presence of internal or external
pacemakers. Interference produced by the use of electrosurgical devices can
cause a pacemaker to enter an asynchronous mode or can block the pacemaker
effect entirely. Consult the pacemaker manufacturer or hospital Cardiology
Department for further information when use of electrosurgical appliances is
planned for patients with cardiac pacemakers.
If the patient has an implantable cardioverter defibrillator (ICD), contact the ICD
manufacturer for instructions before performing an electrosurgical procedure.
Electrosurgery may cause multiple activation of ICDs.
Do not use electrosurgical equipment unless properly trained to use it in the
specific procedure being undertaken. Use by physicians without such training has
resulted in serious, unintended patient injury, including bowel perforation and
irreversible tissue necrosis.
For surgical procedures where the high frequency current could flow through
parts of the body having a relatively small cross-sectional area, the use of bipolar
techniques may be desirable to avoid unwanted coagulation.
In some circumstances, the potential exists for alternate site burns at points of
skin contact (e.g., between the arm and the side of the body). This occurs when
electrosurgical current seeks a path to the patient return electrode that includes
the skin-to-skin contact point. Current passing through small skin-to-skin contact
points is concentrated and may cause a burn. This is true for grounded, ground
referenced, and isolated output generators.
To reduce the potential for alternate site burns, do one or more of the following:
• Avoid skin-to-skin contact points, such as fingers touching leg, when
positioning the patient.
• Place 5 to 8 cm (2 to 3 in.) of dry gauze between contact points to ensure that
contact does not occur.
• Position the patient return electrode to provide a direct current route between
the surgical site and the return electrode that avoids skin-to-skin contact areas.
• In addition, place patient return electrodes according to the manufacturer’s
instructions.
Potential for alternate site burns increases if the return electrode is compromised.
Valleylab recommends the use of split-plate patient return electrodes and
Valleylab generators with a contact quality monitoring system.
Do not wrap the accessory cords or patient return electrode cords around metal
objects. This may induce currents that could lead to shocks, fires, or injury to the
patient or surgical team.
Warning

Safety
1-6 SurgiStat II-20 User’s Guide
Cautions
Caution
At no time should you touch the active electrode or bipolar forceps. A burn could
result.
Do not stack equipment on top of the generator or place the generator on top of
electrical equipment. These configurations are unstable and/or do not allow
adequate cooling.
Provide as much distance as possible between the electrosurgical generator and
other electronic equipment (such as monitors). An activated electrosurgical
generator may cause interference with them.
Nonfunction of the generator may cause interruption of surgery. A backup
generator should be available for use.
Do not turn the activation tone down to an inaudible level. The activation tone
alerts the surgical team when an accessory is active.
When using a smoke evacuator in conjunction with the electrosurgical generator,
place the smoke evacuator at a distance from the generator and set the generator
volume control at a level that ensures that the activation tones can be heard.
The use of high frequency current can interfere with the function of other
electromagnetic equipment.
When high frequency surgical equipment and physiological monitoring equipment
are used simultaneously on the same patient, place any monitoring electrodes as
far as possible from the surgical electrodes.
Do not use needles as monitoring electrodes during electrosurgical procedures.
Inadvertent electrosurgical burns may result.
To avoid the possibility of an electrosurgical burn to either the patient or the
physician, do not allow the patient to come in contact with a grounded metal
object during activation. When activating the unit, do not allow direct skin contact
between the patient and the physician.
Remove any loose fitting jewelry from the patient before activation.

Safety
Introducing the SurgiStat II
Electrosurgical Generator
SurgiStat II-20 User’s Guide 1-7
1. U.S. Department of Health and Human Services. National Institute for
Occupational Safety and Health (NIOSH). Control of Smoke from Laser/Electric
Surgical Procedures. HAZARD CONTROLS, Publication No. 96-128,
September, 1996.
Examine all accessories and connections to the electrosurgical generator before
use. Ensure that the accessories function as intended. Improper connection may
result in arcs, sparks, accessory malfunction, or unintended surgical effects.
When not using active accessories, place them in a holster or in a clean, dry,
nonconductive, and highly visible area not in contact with the patient. Inadvertent
contact with the patient may result in burns.
Studies have shown that smoke generated during electrosurgical procedures can
be potentially harmful to patients and the surgical team. These studies
recommend adequately ventilating the smoke by using a surgical smoke
evacuator or other means.1
Notice
If required by local codes, connect the generator to the hospital equalization
connector with an equipotential cable.
Do not clean the generator with abrasive cleaning or disinfectant compounds,
solvents, or other materials that could scratch the panels or damage the
generator.
Caution

1-8 SurgiStat II-20 User’s Guide

SurgiStat II-20 User’s Guide 2-1
2
2Controls, Indicators,
and Receptacles
This section describes the front and rear panels, including all
controls, indicators, receptacles, the fuse drawer, and ports.
Chapter

Front Panel
2-2 SurgiStat II-20 User’s Guide
Front Panel
Figure 2-1.
Layout of controls, indicators,
and receptacles on the front
panel

Cut and Blend Controls
Controls, Indicators,
and Receptacles
SurgiStat II-20 User’s Guide 2-3
Cut and Blend Controls
Figure 2-2.
Controls for the Cut and Blend
modes
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.
Cut Indicator
Illuminates when
Pure Cut mode is
selected.

Coag and Bipolar Controls
2-4 SurgiStat II-20 User’s Guide
Coag and Bipolar Controls
Figure 2-3.
Controls for the Desiccate,
Fulgurate, and Bipolar modes
Desiccate Selector
When pressed, selects
the Desiccate mode.
Bipolar Selector
When pressed,
selects the Bipolar
mode.
Coag and Bipolar
Power Display (watts)
Indicates the power set
for any Coag or Bipolar
mode.
Coag and Bipolar
Activation Indicator
IlluminateswhenDesiccate,
Fulgurate, or Bipolar modes
are activated.
Coag and Bipolar Power Control Dial
Increases or decreases the Coag or
Bipolar power output in increments of
one watt.
Fulgurate Indicator
Illuminates when
Fulgurate mode is
selected.
Fulgurate Selector
When pressed,
selects the
Fulgurate mode.
Desiccate Indicator
Illuminates when
Desiccate mode is
selected.
Bipolar Indicator
Illuminates when
Bipolar mode is
selected.

Indicators
Controls, Indicators,
and Receptacles
SurgiStat II-20 User’s Guide 2-5
Indicators
Figure 2-4.
Indicators for power, return
electrodes, and footswitch control
Footswitch Control
Selector
When pressed,
switches between
monopolar and
bipolar foot control.
Bipolar Footswitch Control
Indicator and Symbol
Illuminates when bipolar foot
control is selected.
Power Indicator
Illuminates when the
unit is on.
Single-Plate Patient Return
Electrode Indicator
Illuminates when the system
detects a single-plate.
Monopolar Footswitch
Control Indicator and Symbol
Illuminateswhen monopolar foot
control is selected.
Patient Return Electrode Alarm Indicator
Illuminates when the system detects a patient
return electrode alarm condition.
Split-Plate Patient Return
Electrode Indicator
Illuminates when the system
detects a split-plate.

Power Switch and Receptacles
2-6 SurgiStat II-20 User’s Guide
Power Switch and Receptacles
Figure 2-5.
Location of the unit power switch
and front panel receptacles
Monopolar Handswitching
Receptacle
Accepts standard three-pin
handpieces. Connect
handswitching accessories.
Bipolar Receptacle
Accepts standard
cables for Bipolar
handpieces.
Power On/Off Switch
Turns the unit on or off.
Monopolar Footswitching
Receptacle
Accepts cables or adapters equipped
with standard (Bovie #12) active plugs.
Connect footswitching accessories.
Patient Return Electrode
Receptacle
Accepts a standard patient return
electrode plug.