Operations Service Manual
32 Pages
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Operations/Service Manual
VULCAN™ Generator
Glossary of Symbols
VULCAN™ Generator
Non-Sterile
Footswitch
Dangerous Voltage: Danger of electric shock
EU: Not for general waste
CAUTION: U.S. Federal law restricts this device to sale by or on the order of a physician.
UL Classification
Fragile; handle with care
Fuse
This Way Up
Amplitude Control
Keep Dry
ON
Neutral (Return) Electrode Connector (Split Grounding Pad)
OFF
Defibrillator Proof Type BF Equipment
Up and Down Buttons
Equipotentiality
Temperature Range
Alternating Current
Humidity
Non-ionizing Electromagnetic Radiation
European Representative
Protective Earth (ground)
Service lifetime in years
Operations/Service Manual
1061526 Rev. C
Preface / Table of Contents
Preface This manual provides the information required to operate and maintain the Smith & Nephew VULCAN™ Generator. It is essential that all the information in this manual and on the generator label is read and understood before using or maintaining the equipment.
Table of Contents Glossary of Symbols... 3 Preface... 4 Introduction... 5 Device Description... 5 Indications for Use... 5 Contraindications... 5 Warnings... 5-6 Precautions... 7 Unpacking and General Inspection... 7 Front Panel Layout... 8–9 Rear Panel Layout... 10 Preoperative Setup... 11 Operational Modes... 12 Power Delivery Modes... 12 Controls and Functions... 13–14 Instructions for Use... 14–15 Cleaning and Sterilization... 15-16 Service and Maintenance... 16-17 Service Philosophy... 16 Replacing Fuses... 16 Software Upgrades... 17 Replacing/Returning Worn or Defective Equipment or Parts... 17 Preventative Maintenance... 17 Calibration of Temperature Measurement Circuit... 17 Troubleshooting... 18-24 Generator Control Unit... 18 Alarm and Fault Messages... 18–21 Observed Problems... 22–24 Technical Specifications... 25 Ordering Information... 26 Output Charts... 27-28 Output Voltage vs. Output Control... 27 Power Output vs. Output Control, Cut Mode... 27 Power Output vs. Output Control, Coag Mode... 28 Power Output vs. Load Resistance... 28
1061526 Rev. C
Guidance and Manufacturer’s Declaration... 29-31 Electromagnetic Emissions... 29 Guidance for Separation Distances... 29 Electromagnetic Immunity... 30-31 Warranty... Back Cover Service Replacement Units Warranty... Back Cover Service Replacement Program... Back Cover Repair Service Program... Back Cover Figures 1 Control unit front panel... 8 2 Control unit rear panel... 10 3 AC receptacle with fuses... 16
VULCAN™ Generator
Operations/Service Manual
Introduction / Device Description / Indications for Use / Contraindications / Warnings
Introduction
Indications for Use
The Smith & Nephew VULCAN™ Generator is designed to provide finely-controlled radiofrequency (RF) energy for the coagulation, cutting, ablation, and hemostasis of soft tissue during a variety of surgical procedures. The generator control unit is specifically designed for use with Smith & Nephew temperature-controlled and power-controlled probes.
The Smith & Nephew VULCAN Generator is indicated for general surgical purposes, including orthopedic and arthroscopic applications, for coagulation, ablation, and hemostasis of soft tissues in combination with Smith & Nephew temperaturecontrolled, cutting, and ablation probes.
Device Description The generator control unit is a line-voltage powered, radiofrequency generator capable of delivering up to 200 watts of power. The generator control unit includes a neutral electrode monitor (NEM) to monitor split grounding pad contact quality. It is designed to be used only with Smith & Nephew temperaturecontrolled, cutting, and ablation probes and includes the following features: • Two RF output modes: Temperature Control Mode, where the output power is softwarecontrolled to maintain a specified tissue temperature; and Power Control Mode, used for cutting, ablation, and hemostasis. • Numerical displays for impedance, set power, delivered power, set temperature, actual temperature, set cut, set coagulation, and preset selections. • Message display for text messages. • Indicators for electrode type (monopolar or bipolar), mode (Temperature Control or Power Control), stand-by, RF power on, RF output type (cut or coagulation), fault, and split grounding pad monitoring. NEM monitors the split grounding pad connection during surgery, discontinuing RF delivery if a fault in the NEM monitor circuit is detected. • A probe recognition system: the generator control unit automatically selects the appropriate mode and preset settings for the probe type. The Smith & Nephew VULCAN Generator software can be upgraded at the customer’s location with a Smith & Nephew supplied PCMCIA card. For information regarding software upgrades, please contact your authorized Smith & Nephew representative.
VULCAN™ Generator
Operations/Service Manual
Contraindications There are no known absolute contraindications to the use of electrosurgery. The use of the Smith & Nephew VULCAN Generator and accessories is contraindicated, when, in the judgment of the physician, an electrosurgical procedure would be contrary to the best interest of the patient.
Warnings • It is the surgeon’s responsibility to be familiar with the appropriate surgical techniques prior to use of this device. • Read these instructions completely prior to use. • DANGER: Risk of explosion if used in the presence of flammable anesthetics, skin preparation agents, or biointestinal gases. • Hazardous electrical output. This equipment should be used only by qualified medical personnel trained in the use of electrosurgery devices. • This device has been tested and verified to comply with the IEC 60601-2-2. This exceeds the requirements specified by FCC part 18 for ISM equipment. This device is intended for operation in a medical facility only. Usage in a residential environment will likely cause unacceptable RF interference for which the user is held responsible. • The generator control unit must be powered from a properly grounded 120–240 VAC, single-phase supply. Excessive risk (leakage current) may result if this equipment is connected to other than the manufacturer’s recommended power distribution system. • Risk of burns or fire. Do not use near conductive materials such as metal bed parts, inner-spring mattresses, etc.
1061526 Rev. C
Warnings (continued)
• Check that the electrical equipment is properly grounded (i.e. plugs contain a ground prong). The generator control unit must be plugged into a hospital-grade AC outlet. • Safe use of monopolar electrosurgery demands proper grounding of the patient and proper insulation between the patient and any metal surfaces. A split pad with a surface area of at least 20 square inches (130 cm2) is required. Valleylab… REM… pads (REF 7209687) meet this dimensional requirement and are recommended by Smith & Nephew for use with the VULCAN™ Generator. Pads with a surface area of less than 20 square inches may have a lower dispersive effect. It is the responsibility of the user to qualify any alternate ground pad. • Use of an inadequate ground pad or incorrect placement of the ground pad may result in a burn injury to the patient. • Improper probe usage may result in patient burns at the return pad. To avoid this, follow the manufacturer’s Instructions for Use. • Do not exceed the RF duty cycle for the probe. • Do not withdraw the probe while energy delivery is activated; this may result in an unintended patient burn or ignition of flammable materials. • When using RF surgical equipment, keep the working part of the RF probe’s active electrode in the field of view to avoid accidental RF burns. Avoid contact of the probe with metal parts of the scope and other conductive accessories by ensuring, before activation of the RF probe, that the active electrode is at sufficient distance from the tip of the scope. • Failure of the radiofrequency surgical equipment could result in unintended increase of output power. • Burns to the surgeon’s hands may be possible if a probe comes into contact with a metal instrument or surface. • Use of electrosurgery in patients with internal or external pacemakers, implantable defibrillators or monitoring equipment may require special considerations. The attending cardiologist and/or the pacemaker manufacturer should be consulted prior to surgery.
1061526 Rev. C
• The operating table should be grounded. • During monopolar electrosurgery the patient should not come into contact with any metal parts which are grounded or which have appreciable capacitance to earth (operating tables, supports, etc.). The use of anti-static sheeting is recommended for this purpose. • During monopolar electrosurgery skin-to-skin contact (i.e., between the arms and body of the patient) should be avoided. Insertion of dry gauze or its equivalent is recommended. • The probe cables and extension cable should be positioned in such a way that contact with the patient or other leads is avoided. Probes not in use should be stored isolated from the patient. • Incorrect actual temperature readings may result in improper treatment. Verify that the TEMPERATURE display reads the expected value (room temperature or body temperature) prior to treatment. If the TEMPERATURE reading is not accurate, check the device and connectors for damage, moisture, or contamination. Clean or replace as needed. • If desired tissue effect is not being achieved, do not increase power beyond the normal range without first inspecting the integrity of the probe and neutral (return) electrode. • To prevent electric shock, unplug the control unit from the electrical outlet before attempting to replace the fuses. • To avoid fire hazard, use only fuses of the correct type, voltage rating, and current rating. • To prevent electric shock, do not remove the control unit cover. There are no userserviceable components inside. Dismantling the equipment will void the warranty. Refer servicing to qualified Smith & Nephew personnel.
VULCAN™ Generator
Operations/Service Manual
Precautions / Unpacking and General Inspection
Precautions U.S. Federal law restricts this device to sale by or on the order of a physician. • Prior to each use, inspect the device to ensure it is functioning properly and not damaged. Do not use a damaged device. • The Smith & Nephew VULCAN™ Generator is designed specifically for use only with Smith & Nephew arthroscopic radiofrequency probes. Do not use other devices with the generator control unit. • Check the probe and extension cable connections for the presence of liquid before use or whenever a probe is connected or disconnected during a procedure. Liquid may enter the connection during a procedure. ANY liquid can cause the connections to short, resulting in erroneous probe recognition or damage to the probe, cable, or generator control unit. • Check the generator control unit’s LCD message display to ensure that the proper probe identification and settings are displayed prior to beginning any procedure. • Use the lowest RF power setting necessary to achieve the desired tissue effect. • This equipment is designed and tested to minimize interference with other electrical equipment. However, if interference occurs with other equipment it may be corrected by one or more of the following measures: – Reorient or relocate this equipment, the other equipment, or both. – Increase the separation between the pieces of equipment. – Connect the pieces of equipment into different outlets or circuits. – Consult a biomedical engineer. • This equipment contains electronic printed circuit assemblies. At the end of the useful life of the equipment it should be disposed of in accordance with any applicable national or institutional related policy relating to obsolete electronic equipment. • Inspect all components, including extension cables and power cord, regularly for wear. Pay particular attention to extension cable insulation. Replace if evidence of deterioration is noted.
VULCAN™ Generator
Operations/Service Manual
• Apparent low output or failure of the generator control unit to function properly at normal operating settings may indicate faulty application of the split grounding pad. • When the generator control unit is used simultaneously with physiological monitoring equipment on the same patient, any monitoring electrodes should be placed as far from the surgical electrodes as possible. Needle monitoring electrodes are not recommended. Monitoring systems using high frequency current-limiting devices are recommended. • Use only the power cord and connector specified for this unit. • Electrical safety testing should be performed by a biomedical engineer or other qualified person. • Do not immerse the footswitch cable.
Unpacking and General Inspection Carefully unpack and inspect all of the components shipped with the Smith & Nephew VULCAN Generator. The following should have been received:
Quantity
Description
1 Smith & Nephew VULCAN Generator (REF 7210812) 1 Smith & Nephew VULCAN Footswitch (REF 7209692) 1 Hospital-grade power cord, country-specific 1 Smith & Nephew VULCAN Generator Operations/Service Manual (REF 1061526) The Smith & Nephew VULCAN Extension Cable (REF 7209693) is available as an accessory for use with probes that do not include an integrated cable. If any parts are missing or damaged, please contact your authorized Smith & Nephew sales representative. Save the carton and packing materials in the event that a component needs to be returned for repair.
1061526 Rev. C
Front Panel Layout
Front Panel Layout
Figure 1. Control unit front panel
IMPEDANCE Display IMPEDANCE displays the impedance in ohms, measured at the tip of the probe. Active in both Temperature Control and Power Control Modes. SET POWER Display with Up/Down Arrows
ACTUAL PWR Display ACTUAL PWR displays the actual power in watts delivered to the probe. Active only in Temperature Control Mode. TEMPERATURE Display
SET POWER displays the maximum probe power output in watts, increased or decreased using the SET POWER up/down arrows. Active only in Temperature Control Mode.
TEMPERATURE displays the actual temperature in degrees Celsius (° C), measured at the tip of the probe. Active only in Temperature Control Mode.
SET TEMP Display and Up/Down Arrows SET TEMP displays the target tissue temperature in degrees Celsius (° C), increased or decreased using the SET TEMP up/down arrows. Active only in Temperature Control Mode.
SET COAG displays the maximum probe power output in watts, increased or decreased using the SET COAG up/down arrows. Active only in Power Control Mode and the probe supports adjustment of SET COAG.
SET CUT Display with Up/Down Arrows
SET BLEND Display with Up/Down Arrows
SET CUT displays the maximum probe power output in watts, increased or decreased using the SET CUT up/down arrows. Active only in Power Control Mode and the probe supports adjustment of SET CUT. PRESET Display with Up/Down Arrows PRESET displays the preset temperature and/or power combination chosen and is adjustable using the PRESET up/down arrows. Settings are displayed as 1, 2, 3, etc. Active in Temperature Control and Power Control Modes when the probe supports adjustment of PRESET.
1061526 Rev. C
SET COAG Display with Up/Down Arrows
The SET BLEND mode is inactive for all probes. FAULT Indicator (Red Light) FAULT illuminates when a fault condition is detected. NEM Indicator (Green or Red Lights) NEM illuminates with a green light when the NEM circuit is correctly connected and with a red light when the NEM circuit is incorrectly connected. NEM will only illuminate when a monopolar probe is being used.
VULCAN™ Generator
Operations/Service Manual
Front Panel Layout (continued)
BI / MONOPOLAR Button The BI / MONOPOLAR button selects the appropriate RF energy mode (monopolar or bipolar). The generator selects the appropriate mode automatically based on the probe type. BI / MONOPOLAR Indicator Either MONO (monopolar) or BIPOLAR is illuminated to identify the appropriate probe type. MODE Button The MODE button selects the appropriate RF energy delivery mode (Temperature Control or Power Control). MODE Indicator Either TEMPERATURE (Temperature Control Mode) or POWER (Power Control Mode) is illuminated to identify the appropriate generator mode. COAG Indicator (Blue Light) COAG illuminates when the generator control unit is delivering RF power and when the blue COAG (right) footswitch is pressed.
RF POWER ON Indicator (Green Light) RF POWER ON illuminates when the generator control unit is delivering RF power. STAND-BY Indicator (Green Light) STAND-BY illuminates when the generator control unit is in Stand-By Mode. Neutral (Return) Electrode Connector Accepts a dual–pin connector specifically designed for neutral electrode monitoring (NEM). Message Display Displays modes, probe type, alarms, warnings, or fault messages. Probe Connector Accepts 8-pin Smith & Nephew temperaturecontrolled, cutting, ablation, and hemostasis probes. The Smith & Nephew VULCAN™ Extension Cable (REF 7209693) may be used with the generator control unit.
CUT Indicator (Yellow Light) CUT illuminates when the generator control unit is delivering RF power and when the yellow CUT (left) footswitch is pressed.
VULCAN™ Generator
Operations/Service Manual
1061526 Rev. C
Rear Panel Layout
Rear Panel Layout
VULCAN™ Generator ∑ Generator ∑ Generador ∑ Générateur ∑ Generatore ∑
Generator ∑ Generator ∑ Gerador ∑ Generator ∑ Generator ∑ ෧ແૺ
OUTPUT POWER 200 W Max. (100–250 U) 460 kHz
7210812 ZL 100–240V~ 50/60Hz, 800VA
81013076 Rev. C 01/2008
Figure 2. Control unit rear panel
Footswitch Connector Accommodates the generator footswitch cable supplied with the Smith & Nephew VULCAN™ Generator. Volume Control This knob adjusts the volume of the energy delivery tone. Fan Outlet Carrying Handle Equipotential Compensator Terminal This terminal can be used to bring other equipment to the same case potential as the generator control unit.
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1061526 Rev. C
Power Cord Connector The power cord connector is part of the power input module, and accommodates the hospital-grade power cord supplied with the Smith & Nephew VULCAN Generator. Fuse Access Door The fuse access door is part of the power input module. See the “Replacing Fuses” section for instructions on fuse replacement. To avoid hazards, use appropriate fuses as specified in the “Technical Specifications” section. On/Off Switch Rocker-type main power switch.
VULCAN™ Generator
Operations/Service Manual
Preoperative Setup
Preoperative Setup WARNINGS: • DANGER: Risk of explosion if used in the presence of flammable anesthetics, skin preparation agents, or biointestinal gases. • Hazardous electrical output. This equipment should be used only by qualified medical personnel trained in the use of electrosurgery devices. • This device has been tested and verified to comply with the IEC 60601-2-2. This exceeds the requirements specified by FCC part 18 for ISM equipment. This device is intended for operation in a medical facility only. Usage in a residential environment will likely cause unacceptable RF interference for which the user is held responsible. • The generator control unit must be powered from a properly grounded 120–240 VAC, single-phase supply. Excessive risk (leakage current) may result if this equipment is connected to other than the manufacturer’s recommended power distribution system. • Risk of burns or fire. Do not use near conductive materials such as metal bed parts, inner-spring mattresses, etc. 1. Plug the power cord into the rear panel power cord connector and a grounded AC power source. WARNING: Check that the electrical equipment is properly grounded (i.e., plugs contain a ground prong). The generator control unit must be plugged into a hospital-grade AC outlet. 2. Inspect the footswitch for any obvious defects. Connect the footswitch cable to the appropriate connector on the rear of the generator control unit. 3. Prepare the patient using standard technique for electrosurgical procedures. The patient’s entire body, including extremities, must be insulated against contact with grounded metal parts, and sufficient layers of electrically insulating sheets should be placed underneath the patient. A waterproof cover should be placed over the insulating sheets, with absorbent sheets placed between the patient and the waterproof cover to absorb any moisture.
VULCAN™ Generator
Operations/Service Manual
WARNING: The operating table should be grounded. 4. For monopolar procedures, affix the split grounding pad to the patient according to the instructions found in the pad packaging. Select a well-vascularized application site in close proximity to the surgical site. Avoid bony or hairy prominences. Shave, clean, and dry the application site as needed. Apply the pad firmly, assuring full adhesion and contact with the patient’s skin. After the pad is properly applied to the patient, connect the pad to the NEM connector on the control unit front panel. Note: It is important that the split grounding pad be connected to the generator control unit after the pad is properly placed on the patient. This allows the generator control unit to determine an accurate baseline split grounding pad contact quality measurement for a particular patient and will allow the system the greatest resolution in determining if a loss of split grounding pad contact occurs during the procedure. WARNINGS: • Safe use of monopolar electrosurgery demands proper grounding of the patient and proper insulation between the patient and any metal surfaces. A split pad with a surface area of at least 20 square inches (130 cm2) is required. Valleylab… REM… pads (REF: 7209687) meet this dimensional requirement and are recommended by Smith & Nephew for use with the VULCAN™ Generator. Pads with a surface area of less than 20 square inches may have a lower dispersive effect. It is the responsibility of the user to qualify any alternate ground pad. • Use of an inadequate ground pad or incorrect placement of the ground pad may result in a burn injury to the patient. • Improper probe usage may result in patient burns at the return pad. To avoid this, follow the manufacturer’s Instructions for Use.
1061526 Rev. C
11
Operational Modes / Power Delivery Modes
Operational Modes
Power Delivery Modes
Power Up
Temperature Control Mode
When the AC power to the generator control unit is turned on using the power switch on the rear panel, the generator performs a series of system self-tests to determine if it is performing properly. The self-tests include:
If the MODE button is pressed once while the generator is in Stand-By Mode or if a temperature controlled probe is connected to the generator, the generator will enter the Temperature Control Mode. In Temperature Control Mode, the Smith & Nephew VULCAN™ Generator software automatically adjusts energy delivery to maintain the tissue temperature indicated in the SET TEMP display. Only monopolar temperature-controlled probes may be used in Temperature Control Mode.
ROM checksum RAM test Temperature measurement calibration test RF system test Display segments and indicators test If any of the system self-tests fail, the FAULT indicator on the front panel is illuminated and a continuous tone sounds. Contact Smith & Nephew if any system self-test fails. WARNING: Failure of the radiofrequency surgical equipment could result in unintended increase of output power.
Stand-By Mode Immediately after performing the self-test, the generator will default to Stand-By Mode. All of the displays on the front panel will be blanked, and the generator control unit will not be able to deliver RF power while it is in Stand-By Mode.
Fault Mode If a fault is detected at any time during the generator control unit’s operation, the FAULT indicator light will illuminate, an alarm will sound, an error code and text message will be displayed in the message display, and the generator will enter the Fault Mode. RF energy cannot be delivered and the control unit must be powered down then powered up again to exit from Fault Mode.
All Smith & Nephew probes are equipped with a sensor that enables the generator control unit to detect the type of probe connected. When a probe is connected, the Smith & Nephew VULCAN Generator software will read the sensor and automatically adjust power output and temperature parameters to the preprogrammed settings for the probe type. If a probe is not detected, the generator control unit will default to PRESET “1”, and the SET POWER and SET TEMP displays will show the power and temperature values corresponding to this setting.
Power Control Mode
The generator enters Power Control Mode if the MODE button is pressed once while the unit is in Temperature Control Mode, or twice while in Stand-By Mode, or if a cutting or ablation probe is connected to the control unit. The user may change the type and amount of power delivered by adjusting SET CUT (inactive for ELECTROBLADE™ Resector) or SET COAG (inactive for GLIDER Articular Cartilage Probe). All Smith & Nephew probes are equipped with a sensor that enables the generator control unit to detect the type of probe connected. When a probe is connected, the Smith & Nephew VULCAN Generator software will read the sensor and automatically adjust parameters to the preprogrammed settings for the probe type. If a probe is not detected, the generator control unit will default to PRESET “10”, and the SET CUT and SET COAG displays will show the SET CUT and SET COAG values corresponding to this setting.
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1061526 Rev. C
VULCAN™ Generator
Operations/Service Manual
Controls and Functions
Controls and Functions SET POWER SET POWER may be changed by pressing the up/ down arrows located next to the SET POWER display. Power may be adjusted from 1–50 watts. Pressing the appropriate button repeatedly will adjust the power in increments of 1 watt; holding the button down will scroll through the power settings automatically.
SET TEMP SET TEMP may be changed by pressing the up/ down arrows located next to the SET TEMP display. Temperature may be set from 15–99° C. Pressing the appropriate button repeatedly will adjust the temperature in increments of 1° C; holding the button down will scroll through the temperature settings automatically.
SET CUT SET CUT (inactive for ELECTROBLADE™ Resector) may be adjusted by pressing the up/down arrows located next to the SET CUT display. Power may be adjusted from 1–200 watts or up to the preprogrammed limit for the probe type used. Pressing the appropriate button repeatedly will adjust the power in increments of 5 watts; holding the button down will scroll through the power settings automatically.
PRESET (Temperature Control Mode) Commonly used temperature and power combinations are preprogrammed into the Smith & Nephew VULCAN™ Generator software to allow the operator to quickly configure the generator control unit in Temperature Control Mode. Use the PRESET up/down arrows on the control unit front panel to select the desired setting. The selected setting will be displayed in the front panel PRESET display, and the corresponding temperature and power settings will be displayed in the SET TEMP and SET POWER displays.
VULCAN™ Generator
Operations/Service Manual
PRESET (Power Control Mode) Commonly used SET CUT and SET COAG power combinations are preprogrammed into the generator software to allow the operator to quickly configure the control unit in Power Control Mode. Use the PRESET up/down arrows on the control unit front panel to select the desired setting. The selected setting will be displayed in the PRESET display and the corresponding power settings will be displayed in the SET CUT and SET COAG displays. PRESET is inactive for ELECTROBLADE Resector and GLIDER Articular Cartilage Probes.
SET COAG SET COAG (inactive for GLIDER Articular Cartilage Probes) may be adjusted by pressing the up/down arrows located next to the SET COAG display. Power may be adjusted from 1–200 watts or up to the preprogrammed limit for the probe type used. Pressing the appropriate button repeatedly will adjust the power in increments of 5 watts; holding the button down will scroll through the power settings automatically.
Auto Probe Recognition The Smith & Nephew VULCAN™ Generator software recognizes which type of Smith & Nephew probe is connected to the control unit by reading a sensor in the probe. When a probe is connected to the control unit, the software automatically switches to the appropriate control MODE and PRESET setting (if supported) for that specific probe. The SET TEMP, SET POWER, SET CUT, and SET COAG settings may be changed from their preset values using the up/down arrows next to the respective displays (if supported by the probe). The Smith & Nephew VULCAN Generator software also contains temperature and power limits for each probe type. The SET TEMP, SET POWER, SET CUT, and SET COAG settings cannot be set to values outside the range programmed in the software. This feature ensures that each probe type is used within its safe limits of operation.
1061526 Rev. C
13
Controls and Functions / Instructions for Use
Energy Delivery Tone
Instructions for Use
A tone sounds whenever RF energy is delivered. Volume is adjustable using the volume control knob on the control unit rear panel.
1. Turn the control unit on using the on/off switch on the rear panel. The generator will perform a series of system self-tests to determine if it is performing properly. If any of these tests fail, the FAULT indicator will illuminate and a continuous tone will sound. Contact Smith & Nephew Customer Service if any system self-test fails. Inspect the front panel displays for any system indicator warnings or messages.
In Power Control Mode the tone is a steady sound while RF energy is delivered. In Temperature Control Mode the tone sounds slowly while probe temperature is increasing. The tone sounds more rapidly as the set temperature is approached. The tone is rapid and steady when the set temperature is reached and while it is held. Any variation in tone speed signals the user that the probe temperature is not at the target temperature.
Fault Tone The fault tone sounds briefly during generator control unit startup, and in the event of a warning or fault condition. The volume of the fault tone cannot be adjusted by the user.
Footswitch Connector A dual, electrically-activated footswitch is provided to control RF energy delivery. The blue COAG (right) pedal is used with temperature-controlled probes and with SET COAG in Power Control Mode. The yellow CUT (left) pedal is used with cutting/ablation probes in Power Control Mode.
Temperature Control Mode Yellow CUT pedal – inactive Blue COAG pedal – enables coagulation output with temperature control
Power Control Mode Yellow CUT pedal – enables cut output Blue COAG pedal – enables coagulation output
After completing the self-tests, the generator will default to Stand-By Mode. All the displays on the front panel will be blank and the generator will not be able to deliver RF power. 2. Connect the selected Smith & Nephew probe to the probe connector on the control unit front panel. If the probe includes an integrated cable, insert the cable connector with the thumb groove up. For probes without an integrated cable, connect the probe to the extension cable. A “click” may be heard. Tug gently on the extension cable to ensure proper connection. Connect the other end of the probe cable into the probe connector. Note: ELECTROBLADE Resectors with a two-prong Valleylab plug end can be plugged into the ELECTROBLADE Adaptor for use with the VULCAN™ Generator. 3. Verify that the selected probe’s name is presented on the message display. The generator software will recognize the probe type by reading a sensor in the probe and will automatically switch to the appropriate power output, MODE, and setting for that specific probe. WARNING: Burns to the surgeon’s hands may be possible if a probe comes into contact with a metal instrument or surface. CAUTION: Check the probe and extension cable connections for the presence of liquid before use or whenever a probe is connected or disconnected during a procedure. Liquid may enter the connection during a procedure. ANY liquid can cause the connections to short, resulting in erroneous probe recognition or damage to the probe, cable, or generator control unit. CAUTION: Check the generator control unit’s LCD message display to ensure that the proper probe identification and settings are displayed prior to beginning any procedure.
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1061526 Rev. C
VULCAN™ Generator
Operations/Service Manual
Instructions for Use / Cleaning and Sterilization
4. Confirm that the NEM light is illuminated green. If illuminated red, check the split grounding pad to assure full adhesion and contact with the patient’s skin.
being delivered. Different tones are generated for CUT and COAG.
5. If using a temperature-controlled probe, proceed to step 6. If using a power-controlled probe, skip steps 6–8 and proceed directly to step 9.
10. RF energy delivery may be discontinued at any time by releasing the footswitch. To resume RF energy delivery, press and hold the footswitch again.
6. For temperature-controlled probes, check the temperature display to confirm expected values. WARNING: Incorrect actual temperature readings may result in improper treatment. Verify that the TEMPERATURE display reads the expected value (room temperature or body temperature) prior to treatment. If the TEMPERATURE reading is not accurate, check the device and connectors for damage, moisture, or contamination. Clean or replace as needed. CAUTION: Use the lowest RF power settings necessary to achieve the desired tissue effect. 7. To begin RF energy delivery, depress and hold the blue COAG footswitch for the type of power to be delivered, according to the probe’s Instructions for Use. The green RF POWER ON and blue COAG indicator lights will illuminate. WARNING: If desired tissue effect is not being achieved, do not increase power beyond the normal range without first inspecting the integrity of the probe and neutral (return) electrode. 8. During energy delivery, the generator sounds a fluctuating tone. The tone pulsates slowly while probe temperature is ramping up to the SET TEMP. The tone will sound more rapidly as the SET TEMP is approached. The tone is rapid and steady when the SET TEMP is reached and while it is held. Any variation in tone speed signals the user that probe temperature is not at the target temperature. 9. To begin RF energy delivery in the Power Control Mode, depress and hold the selected footswitch for the type of power to be delivered, according to the probe’s Instructions for Use. Select the yellow CUT pedal for the cut output and the blue COAG pedal for the coagulation output. The green RF POWER ON and yellow CUT or blue COAG indicator lights will illuminate. Note: During energy delivery in the Power Control Mode, a steady tone will sound while RF energy is
VULCAN™ Generator
Operations/Service Manual
WARNING: Do not exceed the RF duty cycle for the probe.
WARNING: Do not withdraw the probe while energy delivery is activated; this may result in an unintended patient burn or ignition of flammable materials.
Cleaning and Sterilization Generator Control Unit The unit should be disconnected from the grounded AC outlet when being cleaned. The exterior surface of the control unit may be wiped down with any liquid disinfecting solution; non-flammable solution should be used. Care must be taken not to allow any liquid to pass into any electrical connections or the interior of the control unit. Let the surfaces dry thoroughly before plugging in the device. DO NOT steam sterilize the control unit. DO NOT immerse the generator control unit in glutaraldehyde or other liquid sterilant or disinfectant. DO NOT submerge control unit for any reason.
Smith & Nephew VULCAN™ Extension Cable The Smith & Nephew VULCAN Extension Cable (REF 7209693) is reusable and may be cleaned and sterilized as follows: 1. Rinse the cable with warm running tap water for a minimum of two minutes or until all visible debris is removed. 2. Place the cable in a bath containing Klenzyme… (enzymatic detergent), prepared according to the manufacturer’s instructions, for two minutes. Make sure that there is sufficient detergent to cover the cable. 3. Rinse the cable thoroughly under warm running tap water for one minute. 4. Prepare a solution of commercially available manual cleaner (i.e., Manu-klenz…) according to the manufacturer’s instructions. Gently scrub the cable using a soft, non-metallic brush while the cable is immersed in the cleaning solution.
1061526 Rev. C
15
Cleaning and Sterilization / Service and Maintenance
5. Rinse the cable thoroughly under warm running tap water for one minute. 6. Dry the devices with a soft, clean cloth. 7. Autoclave using the following parameters: – Dry time: No dry time needed. – Pre-vac: Four minutes steam exposure at 132–135° C. – Flash gravity: Ten minutes steam exposure at 131.5–133.5° C (target=132° C). Note: Cables may be individually wrapped in surgical kraft paper and then placed in individual sterilization pouches prior to pre-vac sterilization.
Footswitch The footswitch may be wiped down with any liquid disinfecting solution; non-flammable solution should be used. CAUTION: Do not immerse the footswitch cable.
Probes Smith & Nephew probes are disposable and are intended for single-use only. Do not attempt to clean or resterilize any Smith & Nephew probe.
Service and Maintenance Service Philosophy There are no user-serviceable components inside the generator control unit. Repairs and adjustments are to be performed only by Smith & Nephew authorized service centers.
It is not necessary to include accessory items (i.e., power cords, footswitches, etc.) when returning a device for service.
Replacing Fuses WARNING: To prevent electric shock, unplug the control unit from the electrical outlet before attempting to replace the fuses. WARNING: To avoid fire hazard, use only fuses of the correct type, voltage rating, and current rating. Note: Fuses that require frequent replacement may indicate an internal problem with the control unit. If fuses continue to blow, contact Smith & Nephew Customer Service for assistance.
To Inspect and/or Replace Fuses 1. Unplug the power cord from the power outlet and from the control unit. 2. Use a screwdriver to open the fuse compartment door on the AC receptacle (Figure 3) and slide out the two fuse carriers. Refer to the “Rear Panel Layout” section to locate the AC receptacle on the rear panel. 3. Replace fuses. See “Technical Specifications” section for replacement fuse types. 4. Reinsert the fuse carriers using the arrows on the inside of the fuse compartment door as a guide. 5. Snap the fuse compartment door closed.
If service becomes necessary, call your authorized Smith & Nephew Customer Service Representative prior to returning the device and request a Return Authorization (RA) number. Your representative can also explain the available Service Replacement and Repair Programs. Service items should be carefully repackaged and returned post-paid to Smith & Nephew. Your Smith & Nephew Customer Service Representative can provide additional instructions. Note: Product returned that is found to have been serviced by an unauthorized third party repair facility and/or sterilized with a sterilization method other than one approved by Smith & Nephew will incur additional costs, regardless of warranty status.
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Fuse
ON/OFF Switch Fuse Carrier
Figure 3. AC receptacle with fuses
VULCAN™ Generator
Operations/Service Manual
Service and Maintenance
Software Upgrades For information regarding software upgrades, please contact your local authorized Smith & Nephew representative.
on the “absolute” temperature measured by a temperature probe; therefore, this calibration must be manually checked.
Equipment
Replacing/Returning Worn or Defective Equipment or Parts
• Thermometer
Contact Smith & Nephew Customer Service to order replacement footswitches, extension cables, or any other accessory, and for instructions on disinfection and return of worn-out or defective equipment or parts.
• Beaker
Other than fuses, the Smith & Nephew VULCAN™ Generator has no customer-serviceable parts. For service, please contact your representative or Smith & Nephew Customer Service.
Preventative Maintenance The following inspections should be performed on an annual basis to ensure safe operation of the Smith & Nephew VULCAN Generator.
Inspection of Cables Inspect the power cable and replace if signs of wear or abrasion are visible.
Inspection of Connectors
• TAC™-S Probe with connecting cable
Procedure 1. Fill the beaker with cool water (10–30° C). 2. Use the thermometer to measure and record the temperature of the cool water. 3. Turn on the control unit and connect the cable of the test TAC-S Probe. Verify that the control unit goes into the Temperature Control Mode. The TEMPERATURE should display room temperature. 4. Immerse the tip of the TAC-S Probe in the water and record the actual temperature. 5. Repeat steps 1–4 using hot water (50–90° C). The TEMPERATURE reading with the TAC-S Probe should be +/- 3° C of the thermometer reading in both cases. If a greater difference is observed, contact Smith & Nephew for assistance.
Inspect all connectors on the control unit for signs of wear or damage. Look specifically for bent or damaged pins, loose fittings, etc. Contact Smith & Nephew Customer Service for assistance if any damage is detected.
Calibration of Temperature Measurement Circuit There is no method for the user to alter the calibration of the temperature measurement hardware in the field. However, Smith & Nephew recommends that this calibration be checked on an annual basis. If it is found to be out of specification, the device should be returned to Smith & Nephew for repair. The generator performs a self-test during power-up to verify power calibration. There is an internal, 100 ohm resistor which is measured and compared to its specified value. The generator goes into a Fault Mode if the calibration is out of specification. In addition, the thermocouple amplifying circuits are checked for calibration. However, there is no check
VULCAN™ Generator
Operations/Service Manual
1061526 Rev. C
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Troubleshooting)
Troubleshooting
Alarm and Fault Messages
Generator Control Unit
The generator detects two types of error conditions: alarms and faults.
The generator control unit includes a message display that provides a text description of any alarm or fault messages. If the system is not operating as expected, check the message display. WARNING: To prevent electric shock, do not remove the control unit cover. There are no user-serviceable components inside. Dismantling the equipment will void the warranty. Refer servicing to qualified Smith & Nephew personnel.
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An alarm is generated to inform the user that the output of the device is being disabled to prevent injury to the patient or damage to the device. Alarms are automatically cleared once the alarm condition returns to its acceptable value. A fault is a more serious error condition and typically occurs as a result of a hardware failure, such as a stuck footswitch or a conversion circuit that is out of calibration. The FAULT indicator light will be illuminated, and requires that the control unit be reset by cycling power. Refer to the “Troubleshooting” section for those faults that can be corrected by the user. If a fault other than those listed occurs, contact Smith & Nephew for assistance.
VULCAN™ Generator
Operations/Service Manual
Troubleshooting (continued)
Alarm and Fault Messages (continued) Type
Message
Alarm
OPEN TC- RF disabled in Temp Control mode
Condition
RF output is not allowed in the Temperature Control Mode unless a valid (Note: “OPEN TC” refers to an temperature measurement open thermocouple circuit.) is returned from the probe’s temperature sensor.
Possible Remedy • Check probe connection to generator control unit. • Replace probe.
Alarm
Cannot use CUT pedal in Temp Control mode
RF output is disabled in the Temperature Control Mode if the yellow CUT footswitch is pressed.
Use COAG pedal.
Alarm
RF Disabled - Check Return Electrode
RF output is disabled in any monopolar mode if the impedance between the electrodes on the split grounding pad is greater than the calculated threshold.
Check that the return electrode is properly applied to the patient and that the cable is properly connected to the generator control unit.
Alarm
LOW LOAD IMPEDANCEOutput power reduced
RF output is reduced to below 5 watts whenever the measured load impedance is less than 40 ohms (or 20 ohms depending on the probe).
Keep active electrode away from metallic surfaces during use.
Alarm
NEM CIRCUIT SHORTEDUse split-pad return
If the impedance calculated during NEM initialization is less than 5 ohms, the unit indicates a NEM contact failure.
• Check that split grounding pad is being used. • Check that the split grounding pad is properly applied to the patient and that the pad is properly connected to the front of the control unit. • To test for proper operation of the NEM circuitry, unplug the neutral electrode and connect a 100 ohm, noninductive resistor across the two pins of the neutral electrode connector. The impedance should be sufficiently high to clear the alarm. If the alarm persists, contact Smith & Nephew.*
*Call Smith & Nephew Technical Support at 1-800-343-5717 in the U.S., or your local Smith & Nephew representative.
VULCAN™ Generator
Operations/Service Manual
1061526 Rev. C
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Troubleshooting (continued)
Alarm and Fault Messages (continued) Type
Message
Alarm
POWER FACTOR LOW RF output is reduced to Output power reduced below 5 watts whenever the calculated power factor is less than 0.2.
Keep active electrode away from metallic surfaces during use.
Alarm
Can’t use COAG pedal The use of the COAG pedal with this probe is not supported with the connected probe.
Use the CUT pedal.
Alarm
RF Disabled - No Probe Detected
Condition
A footswitch was pressed when no probe was connected.
Possible Remedy
Connect a probe prior to pressing a footswitch.
Alarm
Cannot use Temp Cont A thermocouple was Probe in Power Mode detected on a probe.
Use the Temperature Control Mode.
Alarm
Cannot use CUT pedal The CUT pedal was used with Electroblade with the Smith & Nephew DYONICS™ Electroblade™ Resector
Use the COAG pedal.
Fault
CJC Out of Range
Fault
Footswitch Stuck On
The cold-junction Let generator reach room compensator (CJC) portion temperature. of the thermocouple circuit has detected a room temperature outside the expected range of 10–35° C. This may occur if the control unit was exposed to extreme temperatures. One or both footswitches was activated during startup.
• Check each footswitch to make sure a cord or other object is not interfering with the footswitch connection. • Reset the control unit by turning it off and then back on again.
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VULCAN™ Generator
Operations/Service Manual
Troubleshooting (continued)
Alarm and Fault Messages (continued) Type
Message
Condition
Possible Remedy
Fault
Output Load Shorted
The load impedance fell below 40 ohms for longer than is permissible (20 ohms depending on probe).
• Check that probe is not shorted to the surgical cannula or arthroscope. • If no contact to the cannula/ arthroscope is seen, the probe or probe cable may be defective. Remove the probe from the surgical site and reset the control unit (turn off, then on). With the probe in free air, activate the footswitch and note the IMPEDANCE reading displayed. If IMPEDANCE is less than 500 ohms, either the probe or probe cable may be defective. • Replace the probe cable and repeat impedance check. If IMPEDANCE is greater than 500 ohms, the cable was defective. If IMPEDANCE is still less than 500 ohms, the probe may be defective. Contact Smith & Nephew.* • Replace probe and repeat impedance check. If IMPEDANCE is greater than 500 ohms, the probe was defective. If IMPEDANCE is less than 500 ohms, the control unit may need service. Contact Smith & Nephew.*
Fault
RF Board Overtemp
The temperature of the heat sink on the RF power control board has exceeded its specified threshold. Aggressive use of the system, either for an excessive period of time or at excessive power levels, may cause this fault.
Reduce output power or increase idle time between periods of RF power delivery.
*Call Smith & Nephew Technical Support at 1-800-343-5717 in the U.S., or your local Smith & Nephew representative.
VULCAN™ Generator
Operations/Service Manual
1061526 Rev. C
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