G4 Radiofrequency Generator Operators Manual Ver 3.0.4 Rev A July 2020

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Copyright Information © 2020 Boston Scientific Corporation or its affiliates, Valencia, CA, USA All rights reserved.

Caution U.S. Federal law restricts this device to sale by, or on the order of, a physician licensed by the state in which he practices to use, or order the use of, the device.

Limited Warranty Boston Scientific Corporation warrants to the original purchaser that the equipment listed in the Operators’ Manual shall be free from defects in material and workmanship for a period of 1 year from the date of shipment. Boston Scientific’s obligation under this warranty shall be limited to repair or replacement, at the option of Boston Scientific. The above warranty is contingent upon normal usage and does not cover products that have been modified without Boston Scientific’s approval or which have been subjected to unusual physical or electrical stress. Electrodes: Since electrodes are more subject to abuse, the warranty differs from the G4 Generator.

Notices No part of this document may be reproduced, stored in a retrieval system, or transmitted, in any form or by any means-electronic, mechanical, photocopying, recording, or otherwise-without the expressed, written consent of Boston Scientific. Additional copies of this document can be ordered from Boston Scientific. Drawings are for illustration purposes only.

Trademarks All trademarks are the property of their respective holders.

Legal Manufacturer Boston Scientific Neuromodulation Corporation 25155 Rye Canyon Loop Valencia, CA 91355 USA (866) 789-5899 in US and Canada (661) 949-4000, (661) 949-4022 Fax (866) 789-6364 TTY www.bostonscientific.com Email: [email protected]

EU Authorized Representative: Boston Scientific Limited Ballybrit Business Park Galway Ireland T: +33 (0) 1 39 30 97 00 F: +33 (0) 1 39 30 97 99

Para obtener información de contacto de Boston Scientific Argentina SA, por favor, acceda al link www.bostonscientific.com/arg

Para informações de contato da Boston Scientific do Brasil Ltda, por favor, acesse o link www.bostonscientific.com/bra

Boston Scientific (Australia) Pty Ltd PO Box 332 BOTANY NSW 1455 Australia Free Phone 1800 676 133

FCC Statement Concerning RFI The G4 generates and uses radio-frequencies. The equipment may cause interference with other medical equipment in the vicinity. If interference occurs, one or more of the following measures could remedy the problem:  Move the G4 away from the affected equipment.  Plug the G4 into a separate outlet so that it is on a different branch circuit. If necessary, consult the manufacturer of the affected equipment or an experienced technician. In addition, the booklet “How to Identify and Resolve Radio-TV Interference Problems” may be helpful. This booklet is published by the FCC and is available from the U.S. Government Printing Office, Washington, D.C., 20402, Stock No. 00400-00345-4.

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Sections 1. General Information

9. Advanced Settings

1.1 Description

10. Notes & Patient Database

1.2 Indications for Use

10.1 USB Keyboard

1.2.1 Intended Patient Population

11. End Procedure Screen

1.2.2 Intended User Profile

12. Procedure Records

1.2.3 Use Environment

12.1 Procedure Record Files

1.2.4 Operating Principle

12.2 Export to External USB Disk

1.3 Device Classification

12.3 Printing

1.4 Electrical Safety and EMC

13. System Setup

1.5 Electrical Safety Information

13.1 Date, Time, Language & Audio Volume

1.6 Adverse Events

13.2 Touch Screen Calibration

1.7 General Warnings and Precautions

14. Modify Presets Screen

1.7.1 Non-Boston Scientific Equipment

15. Sterilization, Care, and Service

1.7.2 The Dispersive Electrode ("Ground Pad")

15.1 Sterilization

1.7.3 Inspection

15.2 Care

1.7.4 General Usage

15.3 Service

1.7.5 Mains Power

15.4 Fuse Replacement

1.8 Key to Device Markings

16. Troubleshooting

2. Chassis Layout

17. Specifications

3. Using the G4

18. Output Power Curves

3.1 Turning Electrode Output On and Off

19. Accessories

3.2 Testing the G4 Unit 3.3 Common Stop Conditions 3.4 Readings & Displays

4. Start Procedure Screen 4.1 Personal Settings Presets 4.2 User Interfaces

5. Electrode Setup Screen 5.1 Electrode Setup Settings 5.2 Electrode Setup Warnings and Guidelines 5.3 Multiple Electrodes: Relative Lesion Size and Shape 5.3.1 RF Type = Standard (Monopolar) 5.3.2 RF Type = Bipolar

6. Stimulation 6.1 Stimulation Settings

7. Thermal RF 7.1 Thermal RF Settings

8. Pulsed RF 8.1 Pulsed RF Settings

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1. General Information Safe and effective Radiofrequency (RF) lesioning is dependent not only on equipment design, but also on factors under control of the operator. Do not attempt to operate the RFG-4 (G4) prior to completely reading and understanding the instructions for use applicable to each component of the Boston Scientific System, consisting of generator, generator accessories, electrodes and cannula. For generator and generator accessories, refer to this manual; for the use of electrodes and cannula, refer to the respective electrode instructions for use. WARNING: Electric Shock Hazard There are no user serviceable parts inside the G4. To avoid electric shock, return the device to Boston Scientific for servicing. WARNING: Hazardous Electrical Equipment & Active Implants This equipment is intended for use by qualified personnel only. This equipment may damage or interfere with the operation of cardiac pacemakers and other active implants. Do not use within 15 feet (4 meters) of a cardiac pacemaker unless proper cautions have been taken. Before use of the G4 RF Generator, contact the pacemaker company to determine whether the pacemaker needs to be converted to fixed rate pacing during the radiofrequency procedure. When the pacemaker is in the sensing mode, it may interpret the RF signal as a heartbeat and may fail to pace the heart. This equipment has an output which is capable of causing a physiological effect. WARNING: Risk of Burns and Fire Do not use near conductive materials such as metal bed parts or inner spring mattresses. WARNING: Protective Earth Grounding Grounding reliability can only be achieved when the equipment is plugged into a receptacle marked “Hospital Grade”. Any interruption of the Protective Earth conductor will result in a potential shock hazard which cause injury to patient or operator.

1.1 Description The G4 is a lesion generator capable of supplying up to 50 watts of radiofrequency power while continuously monitoring both the tissue impedance and the temperature at the tip of the one, two, three, or four electrodes. It is also capable of producing Stimulation waveforms.

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1.2 Indications for Use The Boston Scientific G4 Radiofrequency Generator is indicated for use in procedures to create radiofrequency lesions for the treatment of pain, or for lesioning nerve tissue for functional neurosurgical procedures. The Boston Scientific G4 Radiofrequency Generator is used with separately approved Boston Scientific Radiofrequency Probes. 1.2.1 Intended Patient Population Patients afflicted with neurological disorders are the intended patient population of the Boston Scientific G4 Radiofrequency Generator. 1.2.2 Intended User Profile Neurosurgeons, Anesthesiologists, and Pain Clinicians are the intended user profile of the Boston Scientific G4 Radiofrequency Generator. 1.2.3 Use Environment The Boston Scientific G4 Radiofrequency Generator is used in a surgical setting as an RF power source to deliver energy through RF Electrodes, and is designed to be as light and portable as possible in this environment. Guidance for electromagnetic environment states is as follows: Floors should be wood, concrete or ceramic tile; if floors are covered with synthetic material, the relative humidity should be at least 30%; mains power quality and power frequency magnetic fields should be at levels characteristic of a typical commercial or hospital environment. 1.2.4 Operating Principle The Boston Scientific G4 Radiofrequency Generator is a high frequency surgical equipment used to generate RF and stimulation signals within specified limits; measure the radiofrequency voltage, current, and power output to specified accuracy within specified range; measure the impedance of the RF system to specified accuracy within specified range; and measure temperature at the RF Electrode to specified accuracy within specified range.

1.3 Device Classification Classifications as per EN 60601-1, the manufacturer describes the G4 as: Type of protection against Electric Shock Degree of protection against Electric Shock Degree of harmful ingress of water Mode of Operation Degree of Safety in the Presence of Flammable Anesthetic Mixture with Air, Oxygen, or Nitrous Oxide

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Class I Type BF Defibrillator Protected IPX0 Ordinary Continuous use Not suitable for use

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1.4 Electrical Safety and EMC The RFG-4 (G4) as a piece of Medical Electrical Equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided below. Guidance and manufacturer’s declaration – electromagnetic emissions The RFG-4 (G4) is intended for use in the electromagnetic environment specified below. The customer or the user of the RFG-4 (G4) should assure that it is used in such an environment. Emissions test

Compliance

Electromagnetic environment – guidance

RF emissions CISPR 11

Group 1

The RFG-4 (G4) uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF emissions CISPR 11

Class A

Harmonic emissions IEC 61000-3-2

Class A

Voltage fluctuations/ flicker emissions IEC 61000-3-3

Complies

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The RFG-4 (G4) is suitable for use in all establishments other than domestic, and may be used in domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes, provided the following warning is heeded: Warning: This equipment/system is intended for use by healthcare professionals only. This equipment/ system may cause radio interference or may disrupt the operation of nearby equipment. It may be necessary to take mitigation measures, such as re-orienting or relocating the RFG-4 (G4) or shielding the location.

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Guidance and manufacturer’s declaration – electromagnetic immunity The RFG-4 (G4) is intended for use in the electromagnetic environment specified below. The customer or the user of the RFG-4 (G4) should assure that it is used in such an environment. IEC 60601 test level

IMMUNITY test

Compliance level

Electrostatic discharge (ESD) IEC 61000-4-2

Contact: 8 kV

Contact: 8 kV

Air: 2 kV, 4 kV, 8 kV, 15 kV

Air: 2 kV, 4 kV, 8 kV, 15 kV

Electrical fast transient/burst IEC 61000-4-4

2 kV

2 kV

100 kHz repetition frequency

100 kHz repetition frequency

Line to Line:  0.5 kV, 1 kV

Line to Line:  0.5 kV, 1 kV

Line to Ground:  0.5 kV, 1 kV, 2 kV

Line to Ground:  0.5 kV, 1 kV, 2 kV

Voltage Dips: 0% UT; 0.5 cycle

Voltage Dips: 0% UT; 0.5 cycle

At 0°, 45°, 90°, 135°, 180°, 225°, 270°, and 315°

At 0°, 45°, 90°, 135°, 180°, 225°, 270°, and 315°

0% UT; 1 cycle

0% UT; 1 cycle

and

and

70% UT; 25/30 cycles

70% UT; 25/30 cycles

Single phase: at 0°

Single phase: at 0°

Voltage Interruptions: 0% UT; 250/300 cycle

Voltage Interruptions: 0% UT; 250/300 cycle

30 A/m

30 A/m

50 Hz or 60 Hz

50 Hz or 60 Hz

Surge IEC 61000-4-5

Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

Power frequency (50/60 Hz) magnetic field IEC 61000-4-8

Electromagnetic environment – guidance Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Mains power quality should be that of a typical commercial or hospital environment.

Mains power quality should be that of a typical commercial or hospital environment.

Mains power quality should be that of a typical commercial or hospital environment. If the user of the RFG-4 (G4) requires continued operation during power mains interruptions, it is recommended that the RFG-4 (G4) be powered from an uninterruptible power supply or a battery.

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

NOTE UT is the a.c. mains voltage prior to application of the test level.

The use of cables other than those specified may result in increased EMISSIONS or decreased IMMUNITY of the G4 RF Generator. The essential performance requirements for the RFG-4 (G4) are to maintain the mode of operation set by the user, monitor the voltage, current, and power output, monitor the temperature and impedance through attached electrodes within specified ranges and acceptable tolerances. Momentary changes in readings due to environmental conditions are acceptable, provided the mode of operation remains unchanged.

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Guidance and manufacturer’s declaration – electromagnetic immunity The RFG-4 (G4) is intended for use in the electromagnetic environment specified below. The customer or the user of the RFG-4 (G4) should assure that it is used in such an environment. IMMUNITY test

Compliance level

IEC 60601 TEST LEVEL

Electromagnetic environment – guidance Professional healthcare facility environment: Portable and mobile RF communications equipment should be used no closer to any part of the RFG-4 (G4), including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance

Conducted RF IEC 61000-4-6

Radiated RF IEC 61000-4-3

3V

3V

0.15 MHz - 80 MHz

0.15 MHz - 80 MHz

6 V in ISM bands between 0.15 MHz and 80 MHz

6 V in ISM bands between 0.15 MHz and 80 MHz

80% AM at 1 kHz

80% AM at 1 kHz

3 V/m

3 V/m

d = 1.2p 80MHz to 800MHz

80 MHz - 2.7 GHz

80 MHz - 2.7 GHz

d = 2.3p 800MHz to 2.7GHz

80% AM at 1 kHz

80% AM at 1 kHz

where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m).

d = 1.2p

Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol:

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the RFG-4 (G4) is used exceeds the applicable RF compliance level above, the RFG-4 (G4) should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the RFG-4 (G4). b Over the frequency range 0.15 MHz to 80 MHz, field strengths should be less than 3 V/m. WARNING: Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.

Recommended separation distances between portable and mobile RF communications equipment and the RF System The RF System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the RF System can help prevent electromagnetic interference by maintaining a minimum distance of 30 cm between portable and mobile RF communications equipment (transmitters) and the RF System. NOTE: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

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Proximity fields from RF wireless communications equipment (IEC 61000-4-3) Frequency Range and Level: RF wireless communication equipment Test Frequency (MHz)

Modulation

Immunity Level (V/m)

385

Pulse Modulation: 18 Hz

27

Pulse Modulation: 217 Hz

9

Pulse Modulation: 18 Hz

28

Pulse Modulation: 217 Hz

28

710 745 780 5240 5500 5785 450 810 870 930 1720 1845 1970 2450

1.5 Electrical Safety Information The G4 is a radiofrequency generator designed to produce local tissue heating at the tip of an electrode by the presence of radiofrequency current. Special isolation transformers are imposed between power lines and internal G4 circuitry, resulting in very low leakage current. The G4 is designed for use in a hospital operating room or interventional procedure room. Not for use in the shielded room of a magnetic resonance imaging system, where the intensity of EM disturbances is high. WARNING: A needle electrode should not be used as the dispersive electrode, as it is possible to burn the patient at this site due to high current densities. In all applications, care should be taken to maximize the surface area of the dispersive electrode. The dispersive electrode should be reliably attached with its entire area against the patient’s body and as close to the operating field as possible. The risk of igniting flammable gases or other materials is inherent in lesioning and cannot be eliminated by device design. Precautions must be taken to restrict flammable materials and substances from the electrosurgical site. The use of flammable anesthetics and nitrous oxide and oxygen should be avoided, unless these agents are suctioned away. Flammable agents used for cleaning or disinfecting should be allowed to evaporate before the application of RF surgery. There is a risk of flammable solutions pooling under the patient and in body cavities. Any fluid pooled in these areas should be removed before the equipment is used. Avoid use of flammable materials, such as gauze or cotton wool when saturated with oxygen. These materials may be ignited by sparks produced in the normal operation of the G4.

1.6 Adverse Events Reported adverse events or complications for RF heat lesions procedures include, but are not limited to, the following: Temporary motor deficit, post-operative pain, skin burns. Refer to the instructions for use for electrode kits used with the generator for additional adverse events that have been reported for specific RF applications. 2020-07

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1.7 General Warnings and Precautions This section contains warnings and precautions relevant to the G4 RF Generator. Additional warnings and precautions are listed throughout this Operator's Manual. NOTICE: The physician and support staff must be the ultimate judge of the appropriateness of, and the method used to perform any medical procedure performed using Boston Scientific equipment. It is not the province of Boston Scientific to instruct in the proper medical use of the equipment. The availability of output modes, settings values, and default settings values on the G4 RF Generator should not be construed as a recommendation of the medical appropriateness of their use in a specific case. WARNING: Proper electrode placement should be verified using anatomical landmarks, sensory and motor stimulation techniques, fluoroscopic guidance, Impedance reading, and good clinical judgment before RF lesion making procedures are initiated. WARNING: The long-term risks of creation of RF lesions have not been established. 1.7.1 Non-Boston Scientific Equipment WARNING: Electromagnetic interference (EMI) produced by the unit during normal operation may adversely affect the performance of other equipment. The performance of this device may be adversely affected by other high frequency surgical devices in close proximity. If a problem occurs, separate the devices. Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the generator, including cables. Otherwise, degradation of performance of this equipment could result. WARNING: Electrodes and probes of monitoring, stimulating and imaging devices, and metallic and conductive implanted hardware or probes, can provide paths for high frequency currents even if they are battery powered, insulated, or isolated at 60 Hz. The risk of burns can be reduced, but not eliminated, by placing the electrodes or probes as far away as possible from the lesion site and from the dispersive electrode. Protective impedances incorporated into the monitoring leads may further reduce the risk of these burns and permit continuous monitoring during energy delivery. Needles should not be used as monitoring electrodes during such procedures. If any physiological monitoring or other electrical apparatus is to be used on the patient simultaneously with this G4 RF Generator, the safety aspects of the arrangement should be studied and cleared by a biomedical or clinical engineer. CAUTION: Do not use the G4 Radiofrequency Generator with components, electrodes, and/or RF Cannulae/needles that are not approved by Boston Scientific. The use of non-Boston Scientific approved components could negatively affect the EMC performance of the system or result in EMC non-compliance. WARNING: Potentially hazardous conditions may exist when accessories of similar connector types are combined. Use only appropriate accessories certified by an accredited test body. WARNING: Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. 2020-07

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WARNING: Do not touch the USB port and the patient simultaneously. NOTE: The EMISSIONS characteristics of this equipment make it suitable for use in industrial areas and hospitals (CISPR 11 class A). 1.7.2 The Dispersive Electrode ("Ground Pad") WARNING: The use and proper placement of dispersive electrodes is a key element in the safe and effective use of this Radiofrequency lesion generator, particularly in the prevention of burns. Read and follow Boston Scientific’s dispersive electrode instructions for preparation, placement, surveillance, removal and use of any dispersive electrode. It is recommended that dispersive electrodes be used that meet or exceed the requirements of EN60601-2-2. WARNING: Use a Boston Scientific approved gel-pad dispersive electrode with at least 110 cm² conductive plate area to disperse and return RF current over as large an area as possible, and thus minimize heating effects at that electrode, and to avoid high current densities and resultant burns in adjacent tissue. NOTICE: The ground pad should be placed in close proximity to the lesion site. WARNING: Observe the dispersive electrode during lesioning for signs of excessive heating. NOTICE: Use of an approved ground pad with a stainless steel RF Cannula may provide a galvanic potential (the “battery effect”) resulting in a single stimulation pulse at the time the TC Electrode is placed into an RF Cannula. This should be anticipated, and does not present any risk or danger to the patient. WARNING: Skin burns can result from the improper use of Ground Pads, including, but not limited to, the following:  Use of Ground Pads with a conductive plate area less than 110 cm2.  Use of expired Ground Pads or Ground Pads with dried gel.  Ground Pads not placed on a well vascularized, muscular, convex area of patient skin.  Use on patient with peripheral vascular deficiency.  Reuse or repositioning of Ground Pad.  Ground Pad placement over scar tissue, inflamed skin, adipose tissue, bony prominences, metal prostheses, ECG electrodes and cables, pacemakers, and areas where fluid may pool.  Use of Ground Pad not in accordance with this G4 RF Generator Operator’s Manual.  Use of a needle as dispersive electrode since a needle may cause skin burns at the reference site due to high current densities. 1.7.3 Inspection WARNING: Never proceed in a temperature monitored procedure if the generator does not read body temperature before you begin delivering RF energy. WARNING: Verify functional safety of the device before each use, using the guidelines detailed in this manual. CAUTION: Prior to each procedure, inspect all cables, electrodes, RF Cannulae, and dispersive electrodes for damage. Check the integrity of the electrode and cable 2020-07

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insulation for signs of damage. Such damage could lead to RF Current loss, heating, and burning at undesired locations. A signal of undesired RF Current loss is that unusually high RF Voltage, Current, or Power values are required to achieve a desired electrode tip Temperature. 1.7.4 General Usage WARNING: To avoid unanticipated stimulation to the patient, do not cycle the generator power or turn the generator power on while the patient is connected to the generator. WARNING: The output of any electrode may change when patient output is being delivered. Do not move electrode(s) or change electrode connections to the generator when patient output is being delivered to any electrode. CAUTION: Avoid electrode tip Temperatures near and above 100 °C, as they may produce focal boiling and charring. CAUTION: Raise the electrode Temperature slowly, particularly with large electrodes. Displayed temperature lags behind the actual temperature due to the thermal mass of the electrode. WARNING: The generator is capable of delivering a significant amount of output. Patient or operator injury can result from improper handling of the active electrode and dispersive electrode, particularly when operating the generator. During energy delivery, the patient should not be allowed to come in contact with metal parts which are earthed or which have an appreciable capacitance to earth. The use of antistatic sheeting is recommended for this purpose. Unshielded leads (active or return) should be positioned so that they cannot come into contact with the patient or other leads connected to the patient and so that they do not run parallel to nearby leads. WARNING: To avoid accidental burns:  Skin-to-skin contact (for example between the arms and body of the patient) should be avoided, for example by insertion of dry gauze.  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 in order to avoid unwanted tissue damage.  The output power selected should be as low as possible for the intended purpose. WARNING: Failure of the generator could result in an unintended increase of output power. CAUTION: The physician should observe and record all Voltage, Current, Power, Temperature and Impedance readings at all times, including when using Auto Ramp or Automatic Temperature Control (“Set Temp” or “Max Temp, see Sections 7.1 & 8.1). This gives the physician a measure of parameter normalcy for a given procedure and electrode size. Any anomalously high Voltage, Currents, Impedance, or Power readings would be apparent and signal possible problems. WARNING: Apparent low power output or failure of the equipment to function correctly at normal settings may indicate faulty application of the dispersive electrode or failure of an electrical lead. Do not increase power before checking for obvious defects or misapplication. Effective contact between the patient and the dispersive 2020-07

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electrode must be verified whenever the patient is repositioned after the initial application of the dispersive electrode. WARNING: Do not continue the application of RF if Temperature readings are erratic or do not rise a sufficiently rapid rate for the amount of RF energy applied. Erratic or sluggish Temperature readings may indicate a faulty cable connection, broken Temperature sensor of the electrode, loss of RF Power into an undesired location, an inability of the generator to control the Temperature or RF output of the electrode, or a misalignment of the temperature-sensing electrode tip with the uninsulated tip of the RF Cannula into which it is inserted. NOTICE: Always have spare electrodes and cables on hand in case a problem arises with the first one during a procedure. Reuseable cables and accessories should be periodically tested. WARNING: Any modification of the G4 Radiofrequency Generator done by unauthorized agents compromises the safety and efficacy of the equipment. 1.7.5 Mains Power CAUTION: Make sure that the wall outlet voltage matches the voltage displayed on the Voltage Selector located on the rear of unit (100, 120, 220, or 240). If not, open the Fuse drawer, remove the Voltage Selector and rotate it to the proper voltage setting. CAUTION: Disconnect all electrodes, ground pad, and associated cables from the G4 before turning the mains power on or off.

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1.8 Key to Device Markings Mains Power Mains Power On Switch Main Power Off Switch Output Control Front-panel Start Button: Turn on electrode output

Front-panel Stop Button: Turn off electrode output

Output Control Knob

Increase output level or setting value Decrease output level or setting value Output Connections Reference Ground Pad Connection and all RF Electrode Output Connections isolated at low and high leakage currents

G 1 2 3 4

Reference Ground Pad Connection (on front panel) RF Electrode Connection 1 (on front panel) RF Electrode Connection 2 (on front panel) RF Electrode Connection 3 (on front panel) RF Electrode Connection 4 (on front panel)

Other Connections Footswitch Remote Control Connection Equipotential Jack Terminal USB Connection (Printer or Memory Stick)

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Readings and Indicators Output On Indicator Light

°C Ω V mA W ms Hz min

Temperature (Degrees Celsius) Impedance (Ohms) Voltage (Volts) Current (Milliamps) Power (Watts) Pulse Duration/Width (milliseconds) Pulse Rate/Frequency (Hertz = 1/Seconds) Time (Minutes:Seconds)

Certifications Unit is compliant with the European Council Directive 93/42/EEC , Medical Device Directive Unit is approved by CSA to the US standard Prescription Use Only Warnings Caution, consult accompanying documents Follow Instructions For Use. Dangerous Voltage. No user-serviceable parts inside. Fuse Warning: Replace as marked. Fire Hazard. DANGER

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Explosion risk if used with flammable anesthetics.

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Unit Identification Catalog Number Lot number Serial Number Date of Manufacture Manufacturer Miscellaneous Defibrillation-proof type BF applied part. Type BF protection against electric shock. Floating or isolated applied part/defibrillator protected.

~

Alternating current (AC) Screen Shot: Save image of screen to Procedure Record

IPX0

Protection against ingression of water: Ordinary Increase audio volume Decrease audio volume Separate Collection

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2. Chassis Layout Output On Indicator: Illuminated when electrode output is on

Touch Screen

Front-panel Start Button: Turn on electrode output

Front Panel

Front-panel Stop Button: Turn off electrode output

Output Control Knob: When Auto Ramp=Off, turn clockwise to increase output level.

Reference Ground Pad Connection (G)

Footswitch Connection

Back Panel

Electrode Connection 1

Electrode Connection 2

Electrode Connection 3

Electrode Connection 4

Adjustable Feet (Underneath)

USB Connection: Attach printer or external USB disk. Fuse box and Mains AC Voltage Selection: 100, 120, 220, 240 Vac

Mains Power Switch: Turn generator on and off.

Equipotential Connection

Mains AC Power Cord Connection

Notes:  Do not touch the USB port and the patient simultaneously.  Electrode connections are made via the CB112-TC or CB103R cables.  When RF Type=Standard, the patient “Reference” connection is made via a CB103B black cable.  An optional Footswitch can turn electrode output on and off (Section 3.1).  The Equipotential Connection ties chassis ground to that of other equipment. WARNING: When connecting any non-medical peripheral equipment to this device, it must be ensured that the equipment combination meets the requirements of IEC 60601-1.

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3. Using the G4

Turn on the G4  Attach power cord to AC receptacle  Disconnect electrodes  Turn Mains Power on. Main Menu

Start Procedure

Records

System Setup

End Procedure

 Load Settings Presets

 Export, Print, Edit, and Delete Records saved on G4's internal disk

 Time & Date

 Export Record to external USB disk

 Modify Settings Presets

 Audio Volume Level  Language

 Patient Database

 Calibrate Touch Screen

 Print Record to USB  Save Settings Preset

 Calibration Information Start Procedure

End Procedure

Electrode Setup

Stimulation

Thermal RF

Pulsed RF

Notes

 Configure electrodes

 Sensory Stimulation  Motor Stimulation

 Set Time & Temperature

 Patient Information

 Label electrodes

 Standard, Stepped & Voltage modes  Set Time and Temperature

 Set Voltage, Pulse Rate, and Pulse Width

 Stage Notes

 Impedance Tone

 Doctor Information  Patient Database

Performing a Procedure

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

Produce Stimulation, Thermal RF, and Pulsed RF output



All operations, readings, screen shots, and notes are saved to a Procedure Record on the G4's internal disk

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3.1 Turning Electrode Output On and Off Electrode output can only be turned on when the G4 displays the Stimulation, Thermal RF, or Pulsed RF screen. Touch-screen Start/Stop Button:  Start: Turn on electrode output  Stop: Turn off electrode output

Front-panel Start Button: Turn on electrode output

Front-panel Stop Button: Turn off electrode output

Footswitch: (Optional) Attach to back panel (Section 2)  Depress: Turn on electrode output  Release: Turn off electrode output

3.2 Testing the G4 Unit Attach one or more Test Plugs (RFG-TP) to active electrode jacks and perform a procedure. The displayed Impedance should be approximately 100 Ω and the displayed Temperature is approximately room Temperature.

3.3 Common Stop Conditions The following conditions turn off electrode output and prompt a dialog.  Open Circuit: Impedance from Electrode to Reference > Open Circuit setting (Sections 5.1 and 9).  Short Circuit: Impedance from Electrode to Reference < Short Circuit setting (Sections 5.1 and 9).  No Temperature: No temperature reading from an Electrode.  Low Temperature: Electrode Temp < 10 °C.  High Temperature: Electrode Temp > 100 °C.  Over Temperature: Electrode Temp > TRF Set Temp or PRF Max Temp.  Disconnect Electrode: Electrodes or ground pad attached to generator do not match current Electrode Setup settings (Section 5.1).  High Current/Power: Current or Power output exceeds limits.

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G4 Radiofrequency Generator Operator’s Manual 92212766-12 Page 16 of 43