Users Guide
68 Pages
Preview
Page 1
User’s Guide
SurgiStat™ II-20 Electrosurgical Generator
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. Caution
Federal (USA) laws restrict this device to sale by or on the order of a physician.
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.
ii
SurgiStat II-20 User’s Guide
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 which may result in product damage.
SurgiStat II-20 User’s Guide
iii
Table of Contents Conventions Used in this Guide List of Figures vii
iii
Chapter 1. Introducing the SurgiStat II Electrosurgical Generator Key Features
1-2
Components and Accessories Safety
1-3
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 Indicators
2-4
2-5
Power Switch and Receptacles Rear Panel
2-6
2-7
Symbols on the Front Panel
2-8
Symbols on the Rear Panel
2-9
Chapter 3. Getting Started Initial Inspection Installation
3-2
3-2
Function Checks
3-2
Setting Up the Unit
3-2
Checking the Patient Return Electrode Alarm Confirming Modes
3-3
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 Setup Safety Setting Up
4-2 4-4
Preparing for Monopolar Surgery
4-4
Applying the Patient Return Electrode Connecting Accessories
4-5
Preparing for Bipolar Surgery
4-5
Activation Safety
4-6
Activating the Unit
4-8
iv
4-2
4-4
SurgiStat II-20 User’s Guide
Chapter 5. Maintaining the SurgiStat II Cleaning
5-2
Periodic Inspection
5-2
Fuse Replacement
5-3
Chapter 6. Troubleshooting General Troubleshooting Guidelines Correcting Malfunctions
6-2
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 Clean the Generator
7-3
Ship the Generator
7-3
7-2
Chapter 8. Technical Specifications Performance Characteristics Input Power
8-2
Duty Cycle
8-2
Dimensions and Weight
8-2
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 High Frequency (RF) Leakage Current Standards and IEC Classifications
8-5
8-5
8-5
Class I Equipment (IEC 60601-1)
8-5
Type CF Equipment (IEC 60601-1)/Defibrillator Proof Liquid Spillage (IEC 60601-2-2 Clause 44.3) Electromagnetic Interference
8-6
8-6
8-6
Voltage Transients (Emergency Generator Mains Transfer)
8-6
Electromagnetic Compatibility (IEC 60601-1-2 and IEC 60601-2-2) Output Characteristics
8-7
Maximum Output for Bipolar and Monopolar Modes Output Power Curves
8-7
8-8
Monopolar Cut Curves Monopolar Coag Curves Bipolar Curves
8-6
8-8 8-11
8-14
Chapter 9. Warranty
SurgiStat II-20 User’s Guide
v
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
vii
Chapter
1
Introducing 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-20 User’s Guide
1-1
Key Features
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. Important The RECQMS system requires 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.
1-2
SurgiStat II-20 User’s Guide
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.
SurgiStat II-20 User’s Guide
1-3
Introducing the SurgiStat II Electrosurgical Generator
Components and Accessories
Safety
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.
1-4
SurgiStat II-20 User’s Guide
Safety
Warning
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.
SurgiStat II-20 User’s Guide
1-5
Introducing the SurgiStat II Electrosurgical Generator
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.
Safety
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.
1-6
SurgiStat II-20 User’s Guide
Safety
Caution
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. 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.
SurgiStat II-20 User’s Guide
1-7
Introducing the SurgiStat II Electrosurgical Generator
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.
1-8
SurgiStat II-20 User’s Guide
Chapter
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-20 User’s Guide
2-1
Front Panel
Front Panel Figure 2-1. Layout of controls, indicators, and receptacles on the front panel
2-2
SurgiStat II-20 User’s Guide
Cut and Blend Controls
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.
SurgiStat II-20 User’s Guide
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.
2-3
Controls, Indicators, and Receptacles
Cut Indicator Illuminates when Pure Cut mode is selected.
Coag and Bipolar Controls
Coag and Bipolar Controls Figure 2-3. Controls for the Desiccate, Fulgurate, and Bipolar modes
Desiccate Indicator Illuminates when Desiccate mode is selected.
Coag and Bipolar Power Display (watts) Indicates the power set for any Coag or Bipolar mode.
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.
2-4
Coag and Bipolar Power Control Dial Increases or decreases the Coag or Bipolar power output in increments of one watt.
SurgiStat II-20 User’s Guide
Indicators
Indicators Figure 2-4. Indicators for power, return electrodes, and footswitch control
Power Indicator Illuminates when the unit is on.
Split-Plate Patient Return Electrode Indicator Illuminates when the system detects a split-plate.
SurgiStat II-20 User’s Guide
Monopolar Footswitch Control Indicator and Symbol Illuminates when monopolar foot control is selected. Single-Plate Patient Return Electrode Indicator Illuminates when the system detects a single-plate.
Footswitch Control Selector When pressed, switches between monopolar and bipolar foot control.
2-5
Controls, Indicators, and Receptacles
Patient Return Electrode Alarm Indicator Illuminates when the system detects a patient return electrode alarm condition.
Bipolar Footswitch Control Indicator and Symbol Illuminates when bipolar foot control is selected.
Power Switch and Receptacles
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 Footswitching
Monopolar Handswitching Receptacle Accepts standard three-pin handpieces. Connect handswitching accessories.
Receptacle Accepts cables or adapters equipped with standard (Bovie #12) active plugs. Connect footswitching accessories.
2-6
SurgiStat II-20 User’s Guide