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 electrosurgical generator, please refer to the SurgiStat Low-Power Electrosurgical Generator User’s Guide for standard operating precautions.
Precaution 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. Important Indicates an operating tip or maintenance suggestion. SurgiStat Low-Power Electrosurgical Generator Service Manual...
This limited warranty does not apply to any product, or part thereof, which has been repaired or altered in a way so as, in Covidien’s judgment, to affect its stability or reliability, or which has been subjected to misuse, neglect, or accident.
Customer or otherwise embedded in equipment provided by COVIDIEN, and for the sole purpose of Customer’s internal business purpose in the operation of the Product or equipment purchased from, other otherwise provided by, COVIDIEN or its affiliates.
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COVIDIEN’s service site. If you notify COVIDIEN of defects during the warranty period, COVIDIEN will replace the Software or, at its option, refund the purchase price. Your remedy for breach of this limited warranty shall be limited to replacement or refund and shall not encompass any other damages.
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(vii) Products or equipment that have been altered, serviced or modified by a party other than COVIDIEN; or (viii) Software that has been subjected to abnormal physical or electrical stress, misuse, negligence or accident by Customer or a third party.
• Safety Precaution 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 Low-Power Electrosurgical Generator Service Manual...
It provides unsurpassed performance, flexibility, reliability, and user convenience in one compact package. The SurgiStat includes digital technology. This new technology is evident in the self- checking circuitry and error code readouts. The generator offers monopolar and bipolar electrosurgical operations.
In addition, place patient return electrodes according to the manufacturer’s instructions.Potential for alternate site burns increases if the return electrode is compromised. Covidien recommends the use of split patient return electrodes with a contact quality monitoring system. SurgiStat Low-Power Electrosurgical Generator Service Manual...
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When using a smoke evacuator in conjunction with the electrosurgical generator, place the smoke evacuator a distance from the generator and set the generator volume control at a level that ensures that the activation tones can be heard. SurgiStat Low-Power Electrosurgical Generator Service Manual...
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. SurgiStat Low-Power Electrosurgical Generator Service Manual...
Generator Electric Shock Hazards Warning Do not remove any covers or panels exposing the internal components. Refer to a Covidien representative for service. Connect the generator power cord to a properly grounded receptacle. Do not use power plug adapters.
Read all warnings, precautions, and instructions provided with this generator before testing. Notice There are no internal user serviceable parts. For repairs, return the generator to Covidien. The generator contains electrostatic-sensitive components. When repairing the generator, work at a static-control workstation. Wear a grounding strap when handling electrostatic-sensitive components, except when working on an energized generator.
Chapter 2 Controls, Indicators, and Receptacles This section describes the front and rear panels, including all controls, indicators, receptacles, the fuse drawer, and ports. Surgistat Low-Power Electrosurgical Generator Service Manual...
Power Alarm Monopolar Bipolar Cut and Blend Controls Controls for the Cut and Blend modes SurgiStat Low-Power Electrosurgical Generator Pure Cut Desiccate Coag Blend Fulgurate Bipolar Foot Control Return Electrode Power Alarm Monopolar Bipolar Surgistat Low-Power Electrosurgical Generator Service Manual...
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Cut and Blend Activation Indicator Illuminates when either Pure Cut or Blend mode is activated. ⑦ Cut and Blend Power Control Dial Increases or decreases the Cut or Blend power output in increments of one watt. SurgiStat Low-Power Electrosurgical Generator Service Manual...
Desiccate Selector When pressed, selects the Desiccate mode. ③ Fulgurate Indicator Illuminates when Fulgurate mode is selected. ④ Fulgurate Selector When pressed, selects the Fulgurate mode. ⑤ Bipolar Selector When pressed, selects the Bipolar mode. Surgistat Low-Power Electrosurgical Generator Service Manual...
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Coag and Bipolar Activation Indicator Illuminates when Desiccate, Fulgurate, or Bipolar modes are activated. ⑨ Coag and Bipolar Power Control Dial Increases or decreases the Coag or Bipolar power output in increments of one watt. SurgiStat Low-Power Electrosurgical Generator Service Manual...
Monopolar Footswitch Control Indicator Illuminates when monopolar foot control is selected. ⑥ Footswitch Control Selector When pressed, toggles between monopolar and bipolar foot control. ⑦ Bipolar Footswitch Control Indicator Illuminates when bipolar foot control is selected. Surgistat Low-Power Electrosurgical Generator Service Manual...
Footswitch Receptacle Accepts the E6008 or E6008B monopolar footswitch. Use the monopolar footswitch for both monopolar and bipolar activation. Use only a Covidien monopolar footswitch with the SurgiStat Low-Power Electrosurgical Generator. Use of an incompatible footswitch may cause unexpected output.
Blend mode Coag Controls Desiccate mode Fulgurate mode Bipolar mode Indicators Split-plate patient return electrode Single-plate patient return electrode Footswitch (on the selector button) Power Switch, Handpiece Connectors, and Symbols Follow instructions for use (blue) SurgiStat Low-Power Electrosurgical Generator Service Manual...
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Symbols on the Front Panel Symbols Description Consult instructions for use Patient return electrode Type CF equipment RF isolated – patient connections are isolated from earth at high frequency Monopolar output Caution – high voltage Bipolar output 2-10 Surgistat Low-Power Electrosurgical Generator Service Manual...
Fuse Danger Explosion risk if used with flammable anesthetics Testing agency’s certification mark for compliance to electrical safety and electromagnetic-compatibility standards CE Marking indicating conformity to product requirements of the European Union 0086 SurgiStat Low-Power Electrosurgical Generator Service Manual 2-11...
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 (77 °F / 25 °C) and a nominal input power voltage. SurgiStat Low-Power Electrosurgical Generator Service Manual...
10% to 100%, including condensation Atmospheric pressure 50 kPa to 106 kPa Storage Ambient temperature -68 to 86 °F (10° to 30 °C) range Relative humidity 10% to 75%, noncondensing Atmospheric pressure 50 kPa to 106 kPa SurgiStat Low-Power Electrosurgical Generator Service Manual...
Continuous measurement: Once the system establishes the single-plate electrode resistance, an increase of 20 Ω ± 5 Ω in resistance will cause an alarm. When the alarm condition exists, the system deactivates output power. SurgiStat Low-Power Electrosurgical Generator Service Manual...
Reverse polarity, ground open: < 50 μA Sink current at high < 20 μA line, all inputs High Frequency (RF) Leakage Current Bipolar RF leakage < 39 mA current Monopolar RF leakage < 150 mA current (additional tolerance) SurgiStat Low-Power Electrosurgical Generator Service Manual...
Electromagnetic Interference When placed on or beneath an activated Covidien electrosurgical generator, the SurgiStat Low-Power Electrosurgical Generator can be activated without interference. The generator minimizes electromagnetic interference to video equipment used in the operating room.
EMC information provided in the SurgiStat Low-Power Electrosurgical Generator Service Manual. Portable and mobile RF communications equipment can affect the SurgiStat Low-Power Electrosurgical Generator. Refer to the EMC information provided in the SurgiStat Low-Power Electrosurgical Generator Service Manual. SurgiStat Low-Power Electrosurgical Generator Service Manual...
Portable and mobile RF communications equipment can affect medical electrical equipment. The SurgiStat should not be used adjacent to or stacked with other equipment and use adjacent to other devices or stacked with other equipment, the SurgiStat generator should be observed to verify normal operation in the configuration in which it will be used.
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Guidance and manufacturer’s declaration – electromagnetic immunity The SurgiStat is intended for use in the electromagnetic environment listed below. The customer or the user of the SurgiStat should assure that it is used in such an environment. Immunity test IEC 60601 test...
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IEC 61000-4-8 commercial or hospital environment. Note: U is the a.c. mains voltage prior to application of the test level. 3-10 SurgiStat Low-Power Electrosurgical Generator Service Manual...
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Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than the compliance level in each frequency range. Interference may occur in the vicinity of equipment marked with the following symbol. SurgiStat Low-Power Electrosurgical Generator Service Manual 3-11...
RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location which the SurgiStat is used exceeds the applicable RF compliance level above, the SurgiStat should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the SurgiStat.
The curves that follow depict the changes for each mode at specific power settings. All measurements were taken at the nominal input power voltage used for calibration. Output voltage (Vpeak) vs. power setting (Cut, Coag) ① Voltage (Vpeak) ② Power Setting (watts) SurgiStat Low-Power Electrosurgical Generator Service Manual 3-13...
Output voltage (Vpeak) vs. power setting (Bipolar) ① Voltage (Vpeak) ② Power Setting (watts) Output power vs. power settings for all modes ① Output Power (watts) ② Power Setting % of Total Power 3-14 SurgiStat Low-Power Electrosurgical Generator Service Manual...
1000 1500 2000 2500 3000 ① Output Power (watts) ② Load Resistance (ohms) Output power vs. impedance for Blend mode 1000 1500 2000 2500 3000 ① Output Power (watts) ② Load Resistance (ohms) SurgiStat Low-Power Electrosurgical Generator Service Manual 3-15...
1000 1500 2000 2500 3000 ① Output Power (watts) ② Load Resistance (ohms) Output power vs. impedance for Fulgurate mode 1000 1500 2000 2500 3000 ① Output Power (watts) ② Load Resistance (ohms) 3-16 SurgiStat Low-Power Electrosurgical Generator Service Manual...
Output power vs. impedance for Bipolar mode 1000 1250 1500 ① Output Power (watts) ② Load Resistance (ohms) Reference Output Waveforms The following are the output waveforms as viewed on an oscilloscope. Cut Mode Waveform SurgiStat Low-Power Electrosurgical Generator Service Manual 3-17...
Chapter 4 Theory of Operation This section contains the following information: • Block diagram • Functional overview of key circuits • System logic • Control signal inputs and outputs SurgiStat Low-Power Electrosurgical Generator Service Manual...
Block Diagram Block Diagram Functional block diagram of the SurgiStat system Functional Overview of Key Circuits The following descriptions highlight the main circuits. Power Factor Correction Circuit (PFC) The Power Factor Correction Circuit ensures lower power consumption. The circuit is used to correct the power load that is distributed to the unit’s capacitors, providing the lowest...
When connecting a single-plate patient return electrode to the generator, the pad-sensing module detects if the resistance is below 5 Ω. If it is below 5 Ω, the SurgiStat displays the green single-plate LED on the front of the generator.
LC tank circuit; therefore, more energy is delivered to the patient. Monopolar Select Circuit The monopolar select circuit switches the SurgiStat between each of the four monopolar modes. Matrix switches on the front panel allow mode selection. High-voltage relays switch and isolate the four monopolar configurations.
A system clock circuit, composed of an oscillator, provides the basic operating frequency of 5 MHz. The reset circuit provides a single pulse when you turn on the SurgiStat generator. This pulse resets the field programmable gate array to ensure proper operation.
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SurgiStat Control Signal Inputs and Outputs Signal Name Description OUT_SEL This is an output signal from the system logic that controls relays on the main board. They control which output transformer provides the RF output circuit delivered to the patient.
Chapter 5 Generator Operation This section covers the following topics: • Inspecting the generator and accessories • Service personnel safety • Installation and placement • Functional (operational) checks • Operating the generator SurgiStat Low-Power Electrosurgical Generator Service Manual...
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. SurgiStat Low-Power Electrosurgical Generator Service Manual...
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• In addition, place return electrodes according to the manufacturer’s instructions. Potential for alternate site burns increases if the return electrode is compromised. Covidien recommends the use of split return electrodes and Covidien generators with a contact-quality monitoring system.
Installation and Placement Installation and Placement Place the SurgiStat electrosurgical generator on any flat surface with a tilt angle of not more than 10 degrees. The generator relies on natural convection cooling. Do not block the rear vents. Carts with conductive wheels are recommended. For details, refer to the procedures for your institution or to local codes.
If a split return electrode is in use, the system will constantly monitor the resistance the contact between the electrode and the patient. SurgiStat Low-Power Electrosurgical Generator Service Manual...
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Bipolar Activation Indicator illuminates and that the system generates the coagulation activation tone. 6. While activating the Coag mode, rotate the volume control over the full range to verify that the sound is audible throughout the range. SurgiStat Low-Power Electrosurgical Generator Service Manual...
3. While activating the Bipolar mode, rotate the volume control over the full range to verify that the sound is audible throughout the range. 4. Confirm that releasing the Coag pedal or Cut pedal returns the generator to an idle state. SurgiStat Low-Power Electrosurgical Generator Service Manual...
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. SurgiStat Low-Power Electrosurgical Generator Service Manual...
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Coag and Bipolar Power Control Dial. Activate the generator by pressing the appropriate button on the handswitch or footswitch. Notice One footswitch can activate either monopolar or bipolar operation. SurgiStat Low-Power Electrosurgical Generator Service Manual...
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Yellow button Handswitching pencil Yellow or Cut pedal Footswitch Desiccate or Fulgurate modes Blue button Handswitching pencil Blue or Coag pedal Footswitch Bipolar Operation Bipolar mode Blue (Coag) or yellow (Cut) pedal Footswitch 5-10 SurgiStat Low-Power Electrosurgical Generator Service Manual...
Chapter 6 Maintaining the Generator This section covers the following topics: • Cleaning • Periodic inspection • Fuse replacement SurgiStat Low-Power Electrosurgical Generator Service Manual...
Cleaning Covidien recommends that periodic inspection and performance testing be performed every six months. A qualified biomedical technician should conduct this testing to ensure that the unit is operating effectively and safely. Cleaning After each use, clean the generator. Warning Electric Shock Hazard Always turn off and unplug the generator before cleaning.
Use the following fuses: SurgiStat 100-240 V Amps 3.15 A Type Slow Blow Size 5 x 20 mm Important If the unit does not display an error and does not power on, check fuses. SurgiStat Low-Power Electrosurgical Generator Service Manual...
Chapter 7 Troubleshooting This chapter includes error code descriptions and actions to take to resolve them. SurgiStat Low-Power Electrosurgical Generator Service Manual...
Recommended Equipment for Troubleshooting Recommended Equipment for Troubleshooting Use the following equipment to troubleshoot the SurgiStat electrosurgical generator. • Digital multimeter with leads • Electrosurgical analyzer or a true RMS voltmeter, such as a Fluke 8920A • Wideband current transformer, such as a Pearson 4100 •...
10. Insert a monopolar foot-controlled handpiece into the monopolar foot-controlled receptacle on the front of the generator. Check for a secure fit. If the monopolar foot controlled receptacle is damaged, contact your Covidien Service Center. 11. Check the patient return electrode receptacle on the front of the generator for a broken pin or an obstruction.
5. Reinstall the cover by positioning the cover over the chassis. Secure with the original screws. Understanding Error Codes and Audio Tones The SurgiStat generator includes automatic, continual self-diagnostics. If the diagnostics detect an error, the system displays an error code, sounds an audible tone, and deactivates the output power.
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1) Turn the generator off. voltage too high. 2) Verify that the generator is connected to the correct line voltage. 3) If the error code reappears, record the number and contact your Covidien Service Center. SurgiStat Low-Power Electrosurgical Generator Service Manual...
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E8 error will be displayed. cable between the main and 2) The generator cannot be display boards. activated while the error condition is present. 3) Restart the generator to remove the error condition. SurgiStat Low-Power Electrosurgical Generator Service Manual...
Loose or disconnected cable Contact your Covidien Service between main board and display Center. board Main board malfunction Display board malfunction SurgiStat Low-Power Electrosurgical Generator Service Manual...
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RF output stage malfunction Footswitch will not Malfunctioning or damaged activate output footswitch receptacle Contact your Covidien Service Center. Footswitch activation signal lost on main board Incompatible footswitch Use only a Covidien footswitch with the SurgiStat generator. SurgiStat Low-Power Electrosurgical Generator Service Manual...
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Some manufacturers offer RF choke radiated frequencies filters for use in monitor leads. The filters reduce interference when the generator is activated and minimize the potential for an electrosurgical burn at the site of the monitor electrode. SurgiStat Low-Power Electrosurgical Generator Service Manual...
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Can occur during coag Use a lower power setting for the Fulgurate mode or select the Desiccate mode. Abnormal 50-60 Hz leakage Contact your Covidien Service currents Center. 7-10 SurgiStat Low-Power Electrosurgical Generator Service Manual...
Chapter 8 Repair Policy and Procedures This chapter contains the following information: • The manufacturer’s responsibility • Returning the generator for service • Finding service centers SurgiStat Low-Power Electrosurgical Generator Service Manual...
Then, clean the SurgiStat and ship it to Covidien for service. Step 1 – Obtain a Return Authorization Number Call the Covidien Customer Service Center for your area to obtain a Return Authorization Number. Have the following information ready when you call: •...
Return Authorization Number. 3) Ship the generator, prepaid, to the Covidien Service Center. Service Centers For a complete list of service centers worldwide, please refer to the Covidien web site: http://surgical.covidien.com/service-centers SurgiStat Low-Power Electrosurgical Generator Service Manual...
Chapter 9 Board Drawings and Schematics This chapter contains the assembly drawings and schematics for the following printed circuit boards: • Main board • Display board • Relay board • Connector board SurgiStat Low-Power Electrosurgical Generator Service Manual...
Main Board Isolated Power Factor Corrector Circuit Main Board Isolated Power Factor Corrector Circuit SurgiStat Low-Power Electrosurgical Generator Service Manual...
Printed Circuit Board 1 Main Board PCB Top View Printed Circuit Board 1 Main Board PCB Top View Top View 9-14 SurgiStat Low-Power Electrosurgical Generator Service Manual...
Printed Circuit Board 4 High Voltage Relay PCB (Top and Bottom Views) Printed Circuit Board 4 High Voltage Relay PCB (Top and Bottom Views) SurgiStat Low-Power Electrosurgical Generator Service Manual 9-17...