Cosman G4 User Manual

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COSMAN G4 SERVICE MANUAL

Quick Links

General Information

System Testing

Test Equipment

Page 2

Table of Contents

Sections

General Information

Device Classification

Electrical Safety Information

Key to Device Markings

Mains Power

Output Control

Output Connections

Other Connections

Readings and Indicators

Certifications

Warnings

Unit Identification

Other

Chassis Layout

Front Panel Layout

Back Panel Layout

Getting Started

Indications for Use

Unpacking the G4 System

Turning on the G4 & Main Menu

Start Procedure

Records

System Setup

Startup Screen

Date, Time, Language, and Audio Volume

Page 3

System Setup

Touch Screen Calibration

Testing the G4 Unit

Error and Warning Dialogs

Start Procedure Screen

Modify Preset

Electrode Setup

Electrode Setup Screen

Electrode Setup Settings

Graphing Interface

Stimulation Screen

Additional Example Screens

Stimulation Settings

Control Units

Auto Ramp

Thermal RF Screen

Thermal RF Settings

Mode

Stagger Start

Pulsed RF Screen

Pulsed RF Settings

Max Temperature

One Touch Interface

On-screen Start/Stop button

Stimulation Incremental Controls

Thermal and Pulsed RF Automatic Control

Sterilization, Care, and Service

Troubleshooting

Specifications

Page 4

Electrical supply

Output Power Curves

Output Power ver Knob Setting

Output Power ver Resistance

Accessories

Test Equipment

System Testing

Application Program check

Low voltage Oscillator resonance check

Temperature Display calibration check

High volts measurement calibration

Peak voltage display calibration

Off zero lockout test

Display checks

Lesion timer test

Automatic temperature control

Temperature Variation with cables

Impedance Variation with cables

Impedance range tests

No Temp lock-out test

Audio calibration adjustment

Stimulator tests

Maximum RF output test

Electrical Safety Tests

HIPOT Testing

Leakage Testing

Ground Bond Test

Final check out

System Diagram

Page 5

Backplane Board

Schematic Drawings

Backplane Board Assembly

RMS Stim Board Assembly

Current Board Assembly

USB Card Board Assembly

Power Supply Board Assembly

PC Board Assemblies

Topside part placement

Bottomside part placement

Part lists

Data sheets

Certificate of Conformance

Page 6

DATE

11/7/2008 SUPERSEDES N/A

STANDARD PROCEDURE INSTRUCTIONS

COSMAN MEDICAL, INC

G4 Service Manual

SPI #

PAGE 1 of 115 DO NOT ISSUE REV SHEET

ECO # REVISION DESCRIPTION

Eng. Draft 1 Version for initial product release.

Prepared by:____________________________ Date: ____________

11291

REV.

Approved by: ___________________________ Date: ____________

Manufacturing

Approved by: ___________________________ Date: ____________

Engineering

Approved by: ___________________________ Date: ____________

Quality and Regulatory Affairs

Approved by: ___________________________ Date: ____________

Management

Page 7

Cosman G4 Radiofrequency Generator Service Manual (SPI 11291 Rev A)

Section 1

Page 8

Cosman G4 Radiofrequency Generator Service Manual (SPI 11291 Rev A)

Cosman G4

Radiofrequency Generator

Service Manual

Section 1

Page 9

Cosman G4 Radiofrequency Generator Service Manual (SPI 11291 Rev A)

Title and Publication Number

G4 Service Manual SPI 11291 Rev. A

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

Cosman Medical, Inc. 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. Cosman Medical, Inc. obligation under this warranty shall be limited to repair or replacement, at the option of Cosman Medical, Inc. The above warranty is contingent upon normal usage and does not cover products that have been modified without Cosman Medical’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 Cosman Medical, Inc. Additional copies of this document can be ordered from Cosman Medical.

Trademarks

G4, Graphics 4, Graphics Four, and RFG-4 are trademarks of Cosman Medical, Inc. All trade names referenced are the trademarks, registered trademarks, or products of their respective manufacturers.

Manufactured By Cosman Medical, Inc. 76 Cambridge St. Burlington MA 01803 USA Tel: 781-272-6561 Fax: 781-272-6563

Internet Address

www.cosmanmedical.com

EC REP

Neurotechnics Ltd. 8 Manor Park Banbury OX16 3TB United Kingdom

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. 004-00-00345-4.

Section 1

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Cosman G4 Radiofrequency Generator Service Manual (SPI 11291 Rev A)

Sections

1. General Information

1.1 Device Classification

1.2 Electrical Safety and EMC

1.3 Electrical Safety Information

1.4 Key to Device Markings

2. Chassis Layout

2.1 Front Panel Layout

2.2 Back Panel Layout

3. Getting Started

3.1 Description

3.2 Indications for Use

3.3 Unpacking the G4 System

4. Turning on the G4 & Main Menu

5. System Setup

5.1 Date, Time, Language, and Audio Volume

5.2 Touch Screen Calibration

5.3 Testing the G4 Unit

5.4 Error and Warning Dialogs

6. Start Procedure Screen

7. Electrode Setup Screen

7.1 Electrode Setup Settings

8. Graphing Interface

8.1 Stimulation Screen

8.2 Thermal RF Screen

8.3 Pulsed RF Screen

9. One Touch Interface

9.1 Stimulation Screen

9.2 Thermal RF Screen

10. Sterilization, Care, and Service

11. Troubleshooting

12. Specifications

13. Output Power Curves

14. Accessories

15. Test Equipment

16. System Testing

16.1 Application Program check

16.2 Low voltage Oscillator resonance check

16.3 Touch Screen Display test

16.4 Temperature Display calibration check

16.5 High volts measurement calibration

16.6 Peak voltage display calibration

16.7 Off zero lockout test

16.8 Display checks

16.9 Lesion timer test

16.10 Automatic temperature control

16.11 Temperature Variation with cables

16.12 Impedance Variation with cables

16.13 Impedance range tests

16.14 No Temp lock-out test

16.15 Audio calibration adjustment

16.16 Stimulator tests

16.17 Maximum RF output test

17. Electrical Safety Tests

17.1 HIPOT Testing

17.2 Leakage Testing

17.3 Ground Bond Test

18. Final check out

19. System Diagram

20. Schematic Drawings

20.1 Backplane Board Assembly

20.2 RMS Stim Board Assembly

20.3 Current Board Assembly

20.4 USB Card Board Assembly

20.5 Power Supply Board Assembly

21. PC Board Assemblies

21.1 Backplane Board Assembly

21.2 RMS Stim Board Assembly

21.3 Current Board Assembly

21.4 USB Card Board Assembly

21.5 Power Supply Board Assembly

22. Part lists

22.1 Backplane Board Assembly

22.2 RMS Stim Board Assembly

22.3 Current Board Assembly

22.4 USB Card Board Assembly

22.5 Power Supply Board Assembly

23. Data sheet

Section 1

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Cosman G4 Radiofrequency Generator Service Manual (SPI 11291 Rev A)

1. General Information

Safe and effective RF lesioning is dependent not only on equipment design, but also on factors under control of the operator. Do not attempt to operate the G4 prior to completely reading and understanding the instructions for use.

WARNING: Electric Shock Hazard

There are no user serviceable parts inside the G4. To avoid electric shock, return the device to Cosman 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 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 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

1.2 Electrical Safety and EMC

Section 1

Class I

Type BF Defibrillator Protected

IPX0 Ordinary

Continuous use

Not suitable for use

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Cosman G4 Radiofrequency Generator Service Manual (SPI 11291 Rev A)

The G4 has been tested to and meets the requirements of the following Electrical Safety Standards:

EN 60601-1 Medical Electrical Equipment (1990, A1: 1993, A2: 1995, A13: 1996) EN 60601-2-2 Particular Requirements for the Safety of High Frequency

Surgical Equipment (2006)

The G4 has been tested to and meets the requirements of the following EMC Standards:

EN 60601-1-2 Collateral Standards: Electromagnetic Compatibility (2001, A1: 2004)

The following standards apply:

CISPR 11/FCC Part 15 Group 1, Class A, ISM IEC 61000-4-2 (2001), 61000-4-3 (2006), 610004-4 (2004), 61000-4-5 (2005)

1.3 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 radio frequency current. Special isolation transformers are imposed between power lines and internal G4 circuitry, resulting in very low leakage current.

WARNING:

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.

needle electrode should not be used as the dispersive electrode, as it

Section 1

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Cosman G4 Radiofrequency Generator Service Manual (SPI 11291 Rev A)

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 electrode must be verified whenever the patient is repositioned after the initial application of the dispersive electrode.

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.

WARNING: The use and proper placement of dispersive electrodes is a key element in the safe and effective use of this lesion generator, particularly in the prevention of burns. Read and follow Cosman’s dispersive electrode instructions for preparation, placement, surveillance, removal and use of any dispersive electrode. The use of dispersive electrodes that meet or exceed ANSI/AAMI requirements (HF18) is recommended.

WARNING: Use the Cosman’s DGP-PM large area dispersive electrode, a large area gel-pad (with a 110 cm² conductive plate area) or an equivalent 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.

WARNING: The long-term risks of creation of RF lesions have not been established.

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: Electrodes and probes of monitoring, stimulating, and imaging devices 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.

Section 1

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Cosman G4 Radiofrequency Generator Service Manual (SPI 11291 Rev A)

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: Never proceed in a temperature monitored procedure if the generator does not read body temperature before you begin delivering RF energy.

WARNING: Raise the temperature slowly, particularly with large electrodes. Displayed temperature lags behind the actual temperature due to the thermal mass of the electrode.

WARNING: Verify functional safety of the device before each use, using the guidelines detailed in this manual.

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.

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.

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.

NOTICE: Use of DGP-PM 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.

NOTICE: Always record the wattage readings that correspond to a given temperature for a given technique. This gives extra guidance and helps Cosman Medical diagnose problems.

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.

Section 1

Page 15

Cosman G4 Radiofrequency Generator Service Manual (SPI 11291 Rev A)

1.4 Key to Device Markings

Mains Power

Output Control

Mains Power On Switch

Main Power Off Switch

Front-panel Start Button (Turn on electrode output)

Front-panel Stop Button (Turn off electrode output)

Output Control Knob

Output Connections

Reference Ground Pad Connection and all RF Electrode

Output Connections isolated at low and high leakage currents

Reference Ground Pad Connection (on front panel)

RF Electrode Output Connection 1 (on front panel)

Section 1

Page 16

Cosman G4 Radiofrequency Generator Service Manual (SPI 11291 Rev A)

Other Connections

RF Electrode Output Connection 2 (on front panel)

RF Electrode Output Connection 3 (on front panel)

RF Electrode Output Connection 4 (on front panel)

Footswitch Remote Control Connection

Equipotential Jack Terminal

USB Connection (Printer or Memory Stick)

Readings and Indicators

°C

Ω

Output On Indicator Light

Temperature (Degrees Celsius)

Impedance (Ohms)

Voltage (Volts)

Current (Milliamps)

Power (Watts)

Pulse Duration/Width (millisecons)

Pulse Rate/Frequency (Hertz = 1/Seconds)

min

Time (Minutes:Seconds)

Section 1

Page 17

Cosman G4 Radiofrequency Generator Service Manual (SPI 11291 Rev A)

Certifications

Warnings

Unit is compliant with the European Council Directive 93/42/EEC , Medical Device Directive

Unit is approved by CSA to the US standard

Warning: Consult Operator’s Manual.

Warning: Dangerous Voltage. No user-serviceable parts inside.

Fuse Warning: Replace as marked. Fire Hazard.

DANGER

Unit Identification

REF

LOT

Explosion risk if used with flammable anesthetics.

Reorder Number / Catalog Number

Lot number

Serial Number

Date of Manufacture

Section 1

Page 18

Other

Cosman G4 Radiofrequency Generator Service Manual (SPI 11291 Rev A)

IPX0 Protection against ingression of water: Ordinary

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

Section 1

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Cosman G4 Radiofrequency Generator Service Manual (SPI 11291 Rev A)

2. Chassis Layout

2.1 Front Panel Layout

Touch Screen

Reference Ground

Pad Connection (G)

Electrode Output

Connection 1

Electrode Output

Connection 2

Electrode Output

Connection 3

Electrode Output

Connection 4

Output On Indicato

Illuminated when any electrode out

Front-panel Start Button:

Turn on electrode output when the Stimulation (Sec.

8.1 & 9.1), Thermal RF (Sec. 8.2 & 9.2), or Pulsed RF (Sec. 8.3 & 0) screens are displayed.

Front-panel Stop Button:

Turn off electrode output

Output Control Knob: Manual output ramping. Disabled in some modes.

Adjustable

Feet

ut is on

Notes:

• Electrode connections are made by attaching a CB112-TC cable to an “Electrode Output Connection” jack (gray) shown above.

• Patient “Reference” connection is made by attaching a CB103-B black cable or the DGP-PM Ground Pad to the “Reference Ground Pad Connection” jack (black) shown above.

Section 2

Page 20

2.2 Back Panel Layout

Footswitch

Connection

Equipotential

Connection

Cosman G4 Radiofrequency Generator Service Manual (SPI 11291 Rev A)

USB Connection: A printer or external USB disk.

Fuse box and Mains AC Voltage Selection:

RFG-4

COSMAN

MEDICAL

, INC.

Burlington, MA 01803 USA

Electric Shock Hazard DO NOT REMOVE COVERS No User Serviceabl e Parts

RISK OF FIRE.

REPLACE FUSE AS MARKED.

T2AL250V

100/120/220/240VAC ~50/60 Hz

DANGER

Explosion risk if used with flammable anesthetics. Risque D’Explosion. Ne Pas employer en presence d’anesthesiques inflammables.

Mains AC Power Cord Connection

• 100 Vac

• 120 Vac

• 220 Vac

• 240 Vac

Mains Power Switch

ttach

Notes:

• Footswitch Connection: If the optional Footswitch is connected it will function as the Start button when pressed and the Stop button when released in Stimulation, Thermal RF, and Pulsed RF modes. All other functions of the unit remain the same.

• Equipotential Connection: This connection may be used to tie the chassis ground of different pieces of equipment together.

WARNING: When connecting any non-medical peripheral equipment to this device, it must be ensured that the equipment combination meets the requirements of IEC 60601-1-1.

Section 2

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Cosman G4 Radiofrequency Generator Service Manual (SPI 11291 Rev A)

3. Getting Started

3.1 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. All of these functions are described in more detail in subsequent chapters.

3.2 Indications for Use

The Cosman 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 Cosman G4 Radiofrequency Generator is used with separately approved Cosman Radiofrequency Probes.

3.3 Unpacking the G4 System

G4 Box Contains:

G4 RF Lesion Generator C119 Power Cord, Domestic (120 V) or C118 Power Cord, International (220 V) CB112-TC Connecting Cable for Electrodes RFG-TP Test Plug Operator’s Manual

NOTICE: Place the Operator’s Manual in a safe place for later reference.

NOTICE: Save packaging materials for use in the event that the Generator is

shipped back to Cosman Medical, Inc.

4. Turning on the G4 & Main Menu

1. After unpacking the G4 from the shipping box, plug the power cord into the rear of the unit.

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.

2. Plug the power cord into the proper AC receptacle. Rotate the G4’s adjustable feet (Section 2.1) downward change the viewing angle of the front panel.

CAUTION: Disconnect all electrodes, ground pad, and associated cables from the G4 before turnin

3. Press the Main Power On Switch on the back panel of the generator (Section 2.2). The startup screen appears in approximately 2 seconds, and it is displayed for approximately 15 seconds.

the mains power on or off.

Section 3

Page 22

Cosman G4 Radiofrequency Generator Service Manual (SPI 11291 Rev A)

4. If the Time and Date is set, the Main Menu screen is displayed. If the Time and Date is not set, the System Setup screen is displayed and the Time and Date must be set (Section 5.1).

Generator Mains Power is Off

Press Mains Power On Switch on

back panel of generator (Section

2.2). Wait for 2 sec delay.

Startup

Screen

Main

If Time

D t

ate previously se

(15 sec delay)

If Time & Date not set

(15 sec delay)

System

Setup

Section 5

Set Time and Date

Start

Procedure

Start Procedure

Section 6

• Load or Modify Personal

Settings Presets

• Produce Stimulation,

Thermal RF, or Pulsed RF output.

Records

• Review, Edit, Print, Export, or Delete Procedure Records saved on the generator

System

Setup

System Setup

Section 5

• Set Time and Date

• Adjust Audio Volume

• Change Language

• Calibrate Touch Screen

Section 4

Page 23

Cosman G4 Radiofrequency Generator Service Manual (SPI 11291 Rev A)

•

5. System Setup

5.1 Date, Time, Language, and Audio Volume

Main Menu

Section 4

Press

"Calibrate"

Set Date

(Month, Day, Year)

Set Time

(Hour, Minute, AM/PM)

Change Audio

Volume

Press

“Calibrate”

Touch Screen Calibration

Section 5.2

Change

Language

Press

“Main Menu”

Main Menu

Section 4

• Start Procedure

• Records

stem Setup

Section 5

Page 24

Cosman G4 Radiofrequency Generator Service Manual (SPI 11291 Rev A)

5.2 Touch Screen Calibration

1. Carefully press and briefly hold the center of each cross-shaped target. Lift your finger or stylus from the screen and repeat when the target moves. Lift your finger from the screen when the target disappears.

2. When the cross symbol disappears, press anywhere on the screen to return to the System Setup screen (Section 5.1).

3. Before enabling any generator output, verify the calibration by pressing on-screen buttons that appear in a variety of locations across the screen. For instance, press each button or drop-down menu, except the “Calibrate” button, on the System Setup and Main Menu screens. For each tested button, confirm that a button press is recognized if and only if the screen is pressed within the visible border of that button. If this test fails for any tested button, repeat the touch screen calibration.

WARNING: Poor calibration of the touch screen may cause user input to be recognized incorrectly.

NOTICE: Light use of a blunt, plastic stylus (such as that from a touch-screen PDA) to precisely target the cross symbols may improve touch screen calibration. Damage to the touch screen could occur if too much pressure is applied or if a sharp object is used to touch the screen.

NOTICE: Ignore the text “Press the Esc key to cancel”. Touch screen calibration cannot be canceled.

Calibration

Screen

System Setup

Section 5.1

Press

"Calibrate"

Calibration

Complete

Target Center

Section 5

Page 25

Cosman G4 Radiofrequency Generator Service Manual (SPI 11291 Rev A)

5.3 Testing the G4 Unit

The ability of the generator to produce RF output and to measure Temperature and Impedance can be tested by attaching one or more Test Plugs (RFG-TP) to active electrode jacks and performing a procedure. When a Test Plug is attached to an active electrode jack and the output is off, check that the displayed Impedance is approximately 100  and the displayed Temperature is approximately room Temperature.

Section 5

Page 26

Cosman G4 Radiofrequency Generator Service Manual (SPI 11291 Rev A)

5.4 Error and Warning Dialogs

The generator will alert the user with a dialog box when error conditions occur or for other notification purposes. Display of an error dialog box is accompanied by an audible error tone, and the user is prompted

Error or Warning Message: Describes an error condition that has occurred, or describes the function of the available Dialog Box Buttons.

Dialog Box Button: The action o these buttons should always be considered in the context of the Error or Warning Message. For example:

• Ok: Perform the described

action, or acknowledge the error/warning message.

• Cancel: Do not perform the

listed action.

to acknowledge the error condition by pressing a button in the error dialog box. An example of a dialog box is shown below. Common error conditions include the following. See the Troubleshooting guide (Section 11) for more information.

• Open Circuit: Impedance from Electrode to Reference > 3000 

• Short Circuit: Impedance from Electrode to Reference < 30 

• 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 attached to generator do not match current Electrode Setup

settings (Section 7.1).

• High Current/Power: Current or Power output exceeds limits.

Section 5

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Cosman G4 Radiofrequency Generator Service Manual (SPI 11291 Rev A)

6. Start Procedure Screen

Main Menu

Section 4

Press "Start

Procedure” on

Selected Personal

Settings Preset

Personal Settings Presets: The

selected Preset will determine the initial procedure settings, including Doctor Information. These settings can be changed at any time during the procedure. The Preset also determines the User Interface (Graphing: Section 8 or One Touch: Section 9.), which cannot be changed during a procedure. Default Settings Presets for the Graphing and One Touch i are always available, in addition to userdetermined ones.

nterfaces

Press

"Modify

Presets”

Main Menu

screen

Cancel Button: Procedure is not started. Return to Main Menu.

Preset Summary: Shows all settings values for the selected Preset. These will be loaded when “Start Procedure” is pressed.

• Electrode Setup

• Stimulation settings

• Thermal RF settings

• Pulsed RF settings

• Doctor Information

• User Interface

(Graphing: Section 8 or One Touch: Section 9)

Start Procedure Button: The selected Preset is loaded and a new procedure is started. A Procedure Record is created to save settings and readings from the procedure.

Modify Preset

• Edit, Rename, Delete existing Presets

• Create new Presets

Main Menu

Section 4

• Start Procedure

• Records

• System Setup

Section 6

Electrode Setup

Section 7

• Configure and label electrodes

• Perform procedure using

Stimulation, Thermal RF, Pulsed RF, and Notes screens.

Page 28

Cosman G4 Radiofrequency Generator Service Manual (SPI 11291 Rev A)

7. Electrode Setup Screen

Settings Buttons:

Buttons highlighted in green determine the Electrode Setup that applies to the Stimulation, Thermal RF, and Pulsed RF screen. These settings are described in Section

7.1.

Start Procedure

Section 6

Disconnect electrodes and probe from any output connector shown on the screen marked with a red “X”.

Current Personal Settings Preset

Current Electrode Setup

Settings Graphic: Shows the current Electrode Setup settings.

ttach electrodes, and ground pad to the Electrode output connections on the front panel (Section 2.1) as shown on the screen.

Edit Button: Launches a keyboard to edit labels for the active electrode

Label Text: A labels can be assigned to each electrode, or bipolar electrode pair.

Electrode Labels

Keyboard screen

Clear All Button:

Erases all electrode labels

Labels: Lists the current electrode labels.

Mode Bar: Access

other procedure screens:

• Electrode Setup (Section 7)

• Stimulation

(Sec. 8.1 & 9.1)

• Thermal RF

(Sec. 8.2 & 9.2

• Pulsed RF

(Sec. 8.3 & 0)

• Notes

• End Procedure

Press “Ok”: Accept entered text

Press “Cancel”: Discard entered text

Section 7

Page 29

Cosman G4 Radiofrequency Generator Service Manual (SPI 11291 Rev A)

7.1 Electrode Setup Settings

The Electrode Setup settings determine which electrode output connections (Section 2.1) are to be delivered Stimulation, Thermal RF, and/or Pulsed RF output.

• RF Type: This setting determines the polarity of active electrode output connections.

• Standard: (a.k.a. "Monopolar") A Reference Ground Pad must be used for return Currents from

active electrodes flow into Reference Ground Pad Connection (G).

• Bipolar: Return Currents flow from active electrode output connections into other active

electrode output connections. Connections 2 and 3 are at reference potential in this configuration. Voltage, Current, and Impedance readings are displayed for “Bipolar Pairs” of electrodes, i.e. “Electrode 1+2” and “Electrode 3+4”, of which one is at reference potential and the other is at potential indicated by the displayed Voltage reading.

• Active Electrodes: The number of electrode output connections to which active electrodes should

be attached.

• Labels: Text may be assigned to each electrode if RF Type = Standard, and to each bipolar

electrode pair if RF Type = Bipolar. Labels are displayed on the Stimulation, Thermal RF, and Pulsed RF screens, and are logged to the Summary Record.

The current Electrode Setup settings are indicated using the following labeling in the upper-right corner of the Stimulation, Thermal RF, Pulsed RF, and Notes screens, as well as in the Summary Record.

RF Type

Standard 1 One Electrode

Standard 2 Two Electrodes

Standard 3 Three Electrodes

Standard 4 Four Electrodes

Bipolar 2 Two Electrodes: One Bipolar Pair

Bipolar 4 Four Electrodes: Two Bipolar Pairs

Active

Electrodes

Electrode Setup Indicator

Section 7

Page 30

Cosman G4 Radiofrequency Generator Service Manual (SPI 11291 Rev A)

8. Graphing Interface

The Graphing interface is one of two user interfaces available for operation of the generator in Stimulation, Thermal RF, and Pulsed RF modes. The other is One Touch interface (Section 9). Choice of user interface is primarily a matter of user preference, since almost all generator functions (including full automatic ramp and temperature control) are available in both interfaces. The Graphing interface has the following distinguishing characteristics.

• Graphing: In Stimulation mode, the output level is plotted as a bar graph (see Section 8.1). In

Thermal and Pulsed RF modes, Voltage and Temperature are plotted a function of time when RF output is enabled (see Sections 8.2 and 8.3).

• Stimulation Level Annotation: The user can manually mark Stimulation levels (see "Mark Level"

button in Section 8.1) for review in the Procedure Record.

• RF Timer Reset: The Thermal and Pulsed RF timer can be manually reset when output is on (see

Timer, Sections 8.2 & 8.3).

• Manual Thermal RF Temperature Increment: The target Temperature (see "Set Temp Panel",

Section 8.2) for Thermal RF mode can be increased manually in 5°C steps when electrode output is on.

• Manual Output Control: When the “Auto Ramp” setting is Off (see Sections 8.1.2, 8.2.2 & 8.3.2),

the Stimulation, Thermal RF, and Pulsed RF output levels can be controlled with the Output Control Knob. Auto Ramp can be disabled in the One Touch interface (Section 9) only if Automatic Temperature Control is disabled (for use with non-temperature-monitoring electrodes).

Touch Screen

Output On Indicato

Illuminated when any electrode out

Front-panel Start Button:

Turn on electrode output when the Stimulation (Sec.

8.1), Thermal RF (Sec.

8.2), or Pulsed RF (Sec.

8.3) screens are displayed.

Front-panel Stop Button:

Turn off electrode output

Output Control Knob: Manual output ramping when Auto Ramp = Off. Disabled if Auto Ramp = On

ut is on

Reference Ground

Pad Connection (G)

Electrode Output

Connection 1

Electrode Output

Connection 2

Section 8

Electrode Output

Connection 3

Electrode Output

Connection 4

Page 31

Cosman G4 Radiofrequency Generator Service Manual (SPI 11291 Rev A)

8.1 Stimulation Screen

Sensory Mode

Indicator

Output Off

Indicator

Electrode Select Buttons: The selected

electrode reads "Selected". Press "Select" to select other electrodes.

Sensory

Stimulation Mode

Output Off

Output level bars

held from previous

instances of

Stimulation output

Mode Bar: Access

other procedure screens

Electrode Panel (Black area):

Displays all readings for the indicated electrode output.

Personal Settings Preset

Indicato

Electrode Setup Indicator

(Section 7.1)

Screen Shot Button: Save an image of the screen to the Procedure Record.

Mode: Select Sensory or Motor Stimulation output settings

Impedance Tone: Volume of audio tone with frequency proportional to Impedance reading at selected electrode.

Settings Panel: Lists the current Stimulation settings.

Press Change

Button

Output Level Reading: The level of Stimulation output being delivered to the selected electrode in units of Voltage or Current, matching the Stimulation “Control Units” setting.

Mark Level Button:

nnotate current output level in Procedure Record

Sensory

Stimulation Mode

Output On

Output Level Graph: The height of the rightmost bar in selected electrode's panel shows the level of Stimulation output being delivered to the selected electrode. Bars for past instances of Sensory and Motor Stimulation output are shown on the left for

Press Front-panel Start Button or depress Footswitch:

Stimulation output is d only to the selected electrode or bipolar electrode pair.

Impedance reading: Held at pre-output on value (gray

Marked Level

color) when Stimulation output is on. Reads “--- ” when Impedance greater than 3000  (open circuit).

elivered

Press Front-panel Stop Button, release Footswitch, or error occurs: Electrode

output is turned off.

Section 8

Stimulation Settings

Section 8.1.2

• Change settings for Sensory and Motor Stimulation Output

Unselected electrodes read "---". Stimulation output is not delivered to unselected electrodes.

Temperature reading: Reads “-- °C” when Temperature is less than 10°C or absent.

Page 32

Cosman G4 Radiofrequency Generator Service Manual (SPI 11291 Rev A)

8.1.1 Additional Example Screens

The Graphing Stimulation screen will appear differently depending on the current settings:

• Electrode Setup settings (see Section 7.1)

• Stimulation Mode: Sensory or Motor

• Control Units setting: Voltage- or Current-controlled output (see Section 8.1.2)

Motor Stimulation

Four Electrodes

Motor Mode

Indicator

Mode: Select Sensory or Motor Stimulation output

Mode

Electrode Panel (Black area):

Displays all readings for the indicated bipolar electrode pair, e.g. “Electrode 1+2”.

Sensory

Stimulation Mode

One Bipolar Pair

Bipolar readings: Voltage/Current and Impedance between the two electrodes in the bi

olar pair

Sensory

Stimulation Mode

One Electrode &

Units= Current

Output Off

Indicator

Temperature Readings: One Temperature reading from each electrode in bipolar pair. For instance, “E1” indicates a reading from Electrode 1.

Output Level Reading: Shown here in units of Current (mA). This is determined by the Control Units = Current.

Marked Level

Section 8

Page 33

Cosman G4 Radiofrequency Generator Service Manual (SPI 11291 Rev A)

8.1.2 Stimulation Settings

The Electrode Setup settings (Section 7.1) determine the configuration of electrodes when the generator delivers Sensory and Motor Stimulation output. The "Electrode Select Buttons" on the Stimulation screen (see Section 8.1) are used to select one electrode at a time, or one bipolar electrode pair at a time, from those set as "active" on the Electrode Setup screen. Stimulation output is delivered only to the one selected electrode or bipolar electrode pair. The following settings determine the Stimulation output characteristics.

• Control Units (“Units”):

• Voltage: Sensory and Motor Stimulation output is Voltage-regulated.

• Current: Sensory and Motor Stimulation output is Current-regulated.

• Auto Ramp:

• Off: The Sensory and Motor Stimulation output level is controlled manually by the user with

the Output Control Knob (Graphing Interface Only).

• On: The Sensory and Motor Stimulation output level increases automatically after the user

has turned the output on.

• Sensory Pulse Rate (“Pulse Rate”): The rate of Sensory Stimulation output pulses in units of Hertz

(Hz), which is equivalent to units of “Pulses Per Second”.

• Sensory Pulse Width (“Pulse Width”): The width of Sensory Stimulation output pulses in units of

milliseconds.

• Sensory Auto Ramp Max: The maximum output level if Auto Ramp = On.

• Motor Pulse Rate (“Pulse Rate”): The rate of Motor Stimulation output pulses in units of Hertz

(Hz), which is equivalent to units of “Pulses Per Second”.

• Motor Pulse Width (“Pulse Width”): The width of Motor Stimulation output pulses in units of

milliseconds.

• Motor Auto Ramp Max: The maximum Motor Stimulation output level if Auto Ramp = On.

The Stimulation Settings Screen is shown below.

Select settings from drop-

down menus

Custom Setting Keypad

Select “Custom” from a setting drop-down menu

Stimulation Screen

Press “Ok”:

ccept selected

settings.

Section 8.1

Section 8

Page 34

8.2 Thermal RF Screen

Electrode Panel (Black area):

Displays all readings for the indicated electrode output. When enabled, RF output is delivered to this output.

Output Off

Indicator

Cosman G4 Radiofrequency Generator Service Manual (SPI 11291 Rev A)

Personal Settings Preset

Indicato

Electrode Setup Indicator

(Section 7.1)

Screen Shot Button: Save an image of the screen to the Procedure Record.

Timer: Holds value from

last instance of Thermal RF output.

Standard

Mode

Output Off

Temperature & Voltage graphs held from last instance of

Thermal RF output

Mode Ba

other procedur screens

RF Voltage Reading: In units of RMS Volts.

Temperature reading: Reads “-- °C” when Temperature is less than 10°C or absent.

: A

ccess

Standard

Mode

Output On

Graphs of

Temperature &

Voltage readings

over time

Press Front-panel Start Button or depress Footswitch: Thermal RF

output is delivered to all active electrodes.

Press Front-panel Stop Button, release footswitch, timed output completes, or error occurs: Electrode

output is turned off.

Set Temp Panel: Cycle

through Set Temp values when Set Temp is not “Off”.

Settings Panel: Lists the current Thermal RF settings.

Press Change

Button

Thermal RF Settings

Section 8.2.2

• Change settings for Thermal RF output

Timer: Counts up to Set

Temp in Minutes and Seconds (min:sec) w RF output is on. Reset button sets timer to zero.

Set Temp Panel: Increment Set Temp by 5 °C (up to 90 °C) if Set Temp is not “Off”.

Impedance reading: Held at latest value (gray color) when during Stagger Start. Reads “--- ” when Impedance greater than 3000  (open circuit).

hen

RF Power Reading: In units of RMS Watts.

RF Current Reading: In units of RMS Milliam

Section 8

Page 35

Cosman G4 Radiofrequency Generator Service Manual (SPI 11291 Rev A)

8.2.1 Additional Example Screens

The Graphing Thermal RF screen will appear differently depending on the current settings:

• Electrode Setup settings (see Section 7.1)

• Thermal RF Mode: Standard or Stepped (see Section 8.2.2)

Timer: Cannot be reset

in Stepped Mode.

Stepped Mode

One Electrode

Electrode Panel (Black area):

Displays all readings for the indicated bipolar electrode pair, e.g. “Electrode 1+2”.

Standard Mode

One Bi

Bipolar readings: Voltage, Current, Power, and Impedance between the two electrodes in the bi

olar Pair

olar pair

Standard Mode

One Electrode

Temperature Readings: One Temperature reading from each electrode in bipolar pair. For instance, “E1” indicates a reading from Electrode 1.

Section 8

Page 36

Cosman G4 Radiofrequency Generator Service Manual (SPI 11291 Rev A)

8.2.2 Thermal RF Settings

The Electrode Setup settings (Section 7.1) determine the number and configuration of electrodes when the generator delivers Thermal RF output. When Thermal RF output is enabled by the user, it is delivered to all electrodes selected as “active” on the Electrode Setup screen. The following settings determine the Thermal RF output characteristics.

• Mode:

• Standard: Time and Temperature control for the Thermal RF output is determined by the Auto

Ramp, Set Temp, and Set Time settings.

• Stepped: Time and Temperature control for Thermal RF output is determined by the Start Temp,

Step Temp Increment, Final Temp, Step Time, and Final Time settings. RF Voltage is controlled automatically by the generator in order that the Temperatures of active electrodes vary in a stepwise manner.

• Stagger Start: When using multiple electrodes, electrodes will turn on sequentially from low to high

index, spaced in time by this setting value.

• 0 seconds: All electrodes are energized simultaneous when the user enables Thermal RF

output using the front-panel Start button.

• 5-30 seconds: After the user enables Thermal RF output using the front-panel Start button, each

electrode is not energized until Stagger Start seconds after the previous, lower-indexed electrode is energized.

The following settings apply only when Thermal RF Mode = Standard.

• Auto Ramp (Graphing Interface Only):

• Off: Thermal RF output Voltage is controlled manually by the user with the Output Control

Knob on the front panel of the generator.

• On: Thermal RF output Voltage increases automatically after the user has turned the output

on. Applicable only when Automatic Temperature Control is enabled (i.e. Set Temp is not “Off”). The Output Control Knob is inactive.

• Set Temperature (“Set Temp”):

• Off: Automatic Temperature Control is disabled. The generator will not control the Temperature

at any electrode or check for Temperature-related errors. Auto Ramp is set to Off and the Thermal RF output Voltage must be controlled manually by the user with the Output Control Knob. Use this setting with electrodes that do not monitor temperature, e.g. Cosman CR Electrode.

• 37-90 °C: Automatic Temperature Control enabled. Thermal RF output is automatically adjusted

to target the Set Temp value for each electrode.

• Set Time: This setting determines the total amount of time that Thermal RF output is delivered to

each electrode. Once this time interval has elapsed for each electrode, electrode output is disabled automatically.

Section 8

Page 37

Cosman G4 Radiofrequency Generator Service Manual (SPI 11291 Rev A)

)

8.3 Pulsed RF Screen

Electrode Panel (Black area):

Displays all readings for the indicated electrode output. When enabled, RF output is delivered to this output.

Output Off

Indicator

E-dose =

Vary Voltage

Output Off

Temperature & Voltage graphs held from last instance of

Thermal RF output

(None held here)

Mode Ba

other procedur screens

: A

ccess

Personal Settings Preset

Indicato

Electrode Setup Indicator

(Section 7.1)

Screen Shot Button: Save an image of the screen to the Procedure Record.

Timer: Holds value from

last instance of Thermal RF output.

Settings Panel: Lists the current Pulsed RF settings.

Press Change

Button

RF Voltage Reading: In units of Peak Volts.

Temperature reading: Reads “-- °C” when Temperature is less than 10°C or absent.

E-dose =

Vary Voltage

Output On

Graphs of

Temperature &

Voltage readings

over time

RF Current Reading: In units of Peak Milliamps.

Press Front-panel Start Button or depress Footswitch: Pulsed RF

output is delivered to all active electrodes.

Press Front-panel Stop Button, release footswitch, timed output completes, or error occurs: Electrode

output is turned off.

Section 8

Pulsed RF Settings

Section 8.3.2

• Change settings for Thermal RF output

Timer: Counts up t

Set Temp in Minutes and Seconds (min:sec)

Impedance reading:

• Held a latest value (gray color) when during Stagger S Reads “

• --- ” when Impedance greater than 3000  (open circuit

tart.

Page 38

Cosman G4 Radiofrequency Generator Service Manual (SPI 11291 Rev A)

ectrodes

8.3.1 Additional Example Screens

The Graphing Pulsed RF screen will appear differently depending on the current settings:

• Electrode Setup settings (see Section 7.1)

• E-dose setting: Vary Voltage, Vary Width, or Vary Rate (see Section 8.3.2)

Pulse Width Reading:

E-dose = Vary Width

r El

Displayed in units of milliseconds only if E-dose = Vary Width. The Pulse Ra is fixed at the value shown in the Settings Panel.

Electrode Panel (Black area):

Displays all readings for the indicated bipolar electrode pair, e.g. “Electrode 1+2”.

E-dose = Vary Voltage

One Bipolar Pair

Bipolar readings: Voltage, Current, and Impedance between the two electrodes in the bi

olar pair

E-dose = Vary Rate

One Electrode

Settings Panel: If E-dose = Vary Width, the Pulse Width and Pulse Rate are fixed at the values shown here.

Temperature Readings: One Temperature reading from each electrode in bipolar pair. For instance, “E1” indicates a reading from Electrode 1.

Pulse Rate Reading:

Displayed in units of Hertz only if E-dose =

ary Rate. The Pulse Width is fixed at the val

Section 8

Page 39

Cosman G4 Radiofrequency Generator Service Manual (SPI 11291 Rev A)

8.3.2 Pulsed RF Settings

The Electrode Setup settings (Section 7.1) determine the number and configuration of electrodes when the generator delivers Pulsed RF output. When Pulsed RF output is enabled by the user, it is delivered to all electrodes selected as “active” on the Electrode Setup screen. The following settings determine the Pulsed RF output characteristics.

• Stagger Start: When using multiple electrodes, electrodes will turn on sequentially from low to high

index, spaced in time by this setting value.

• 0 seconds: All electrodes are energized simultaneous when the user enables Pulsed RF output

using the front-panel Start button.

• 5-30 seconds: After the user enables Pulsed RF output using the front-panel Start button, each

electrode is not energized until Stagger Start seconds after the previous, lower-indexed electrode is energized.

• Auto Ramp (Graphing Interface Only):

• Off: Pulsed RF output Voltage is controlled manually by the user with the Output Control

Knob on the front panel of the generator.

• On: Pulsed RF output Voltage increases automatically after the user has turned the output

on. Applicable only when Automatic Temperature Control is enabled (i.e. Max Temp is not “Off”). The Output Control Knob is inactive.

• E-Dose: Applicable if Automatic Temperature Control is enabled (i.e. Max Temp is not “Off”), one of

the pulse parameters is automatically reduced to keep all electrode temperatures below the Max Temp setting.

• Vary Voltage: Voltage may be automatically reduced from the Set Voltage setting to keep all electrode temperatures below the Max Temp setting.

• Vary Pulse Width (“Vary Width”): Pulse Width may be automatically reduced from the

Pulse Width setting to keep all electrode temperatures below the Max Temp setting. Voltage

is reduced when the Pulse Width cannot be reduced below its minimum value.

• Vary Pulse Rate (“Vary Rate”): Pulse Rate may be automatically reduced from the Pulse

Rate setting to keep all electrode temperatures below the Max Temp setting. Voltage is

reduced if the Pulse Rate cannot be reduced below its minimum value.

• Max Temperature (“Max Temp”):

• Off: Automatic Temperature Control is disabled. The generator will not control the Temperature

at any electrode. Auto Ramp is set to Off and the Pulsed RF output Voltage must be controlled manually by the user with the Output Control Knob.

• 37-90 °C: Automatic Temperature Control enabled. Pulsed RF output is automatically adjusted

so that electrode Temperatures do not exceed the Max Temp value.

• Set Voltage: The target Voltage amplitude of the Pulsed RF output.

• Pulse Width: The duration in milliseconds of each burst of Pulsed RF output.

• Pulse Rate: The rate in Hz (equivalent to “Pulses Per Second”) at which bursts of Pulse RF output

are delivered.

• Set Time: This setting determines the total amount of time that Pulsed RF output is delivered to

each electrode. Once this time interval has elapsed for each electrode, electrode output is disabled automatically.

Section 8

Page 40

Cosman G4 Radiofrequency Generator Service Manual (SPI 11291 Rev A)

Selected parameters of the Pulsed RF waveform are shown schematically in the illustration below.

Set Time

Voltage

Time

1/Pulse Rate Pulse Width

RF e/ RF off

puls

burst

The Pulsed RF Settings Screen is shown below.

Select settings from

drop-down menus

Select “Custom” from a setting drop-down menu

Press “Ok”:

ccept selected

settings.

Custom Setting Keypad

Pulsed RF Screen

Section 8.3

Section 8

Page 41

Cosman G4 Radiofrequency Generator Service Manual (SPI 11291 Rev A)

9. One Touch Interface

The One Touch interface is one of two user interfaces available for operation of the generator in Stimulation, Thermal RF, and Pulsed RF modes. The other is Graphing interface (Section 8). Choice of user interface is primarily a matter of user preference, since almost all generator functions are available in both interfaces. The One Touch interface has the following distinguishing characteristics.

• On-screen Start/Stop button: An on-screen Start/Stop toggle button is available to enable and

disable electrode output. The mechanical Start and Stop buttons to the right of the Touch Screen are still fully functional, but do not need to be used.

• Stimulation Incremental Controls: When the Stimulation “Auto Ramp” setting is Off (see Sections

9.1 & 9.1.2), Stimulation output is incremented and decremented using on-screen buttons, NOT that Output Control Knob.

• Thermal and Pulsed RF Automatic Control: Automatic output ramping (“Auto Ramp”) cannot be

disabled for Thermal RF and Pulsed RF output unless Automatic Temperature Control is disabled (see Sections 9.2.2 and 9.2.4). Manual output ramping using the Output Control knob can be enabled by setting “Auto Ramp” to Off in the Graphing interface (see Section 8).

Stimulation Increment/Decrement Buttons:

vailable on the One Touch Stimulation

screen when Stimulation Auto Ramp = Off.

On-screen Start/Stop Button:

• Press “Start” to turn electrode output on.

• Press “Stop” to turn electrode output off.

Touch Screen

Reference Ground

Pad Connection (G)

Electrode Output

Connection 1

Electrode Output

Connection 2

Electrode Output

Connection 3

Electrode Output

Connection 4

Output On Indicato

Illuminated when any electrode out

Front-panel Start Button:

Turn on electrode output when the Stimulation (Sec.

9.1), Thermal RF (Sec.

9.2), or Pulsed RF (Sec. 0) screens are displayed.

Front-panel Stop Button:

Turn off electrode output

Output Control Knob: Manual output ramping in TRF & PRF mode if Set/Max Temp=Off. Disabled at all other times.

ut is on

Section 9

Page 42

9.1 Stimulation Screen

Auto Ramp & Units Indicator: Reads

“Auto” if Auto Ramp=On, and “Manual” otherwise. Reads “Voltage” or “Current” to match the Control Units setting.

Output Off

Indicator

Sensory

Stimulation Mode

Output Off

Sensory Mode

Indicator

Cosman G4 Radiofrequency Generator Service Manual (SPI 11291 Rev A)

Electrode Panel (Black area): Displays

all readings for the indicated, selected electrode or bipolar output.

Output Increment & Decrement Buttons: Increase & decrease

the output level when electrode output is on and Auto Ramp=Off.

bsent if Auto Ramp = On.

Personal Settings

Preset Indicato

Electrode Setup

Indicator (Section 7.1)

Screen Shot Button: Save an image of the screen to the Procedure Record.

Start/Stop Button: Press “Start” to turn electrode output on. Press “Stop” to turn electrode output off.

Mode: Select Sensory or Motor Stimulation output settings

Impedance Tone: Volume of audio tone with frequency proportional to Impedance reading at selected electrode.

Electrode Select Buttons: The selected

electrode or bipolar electrode pair is highlighted.

Output Level Reading: The level of Stimulation output being delivered to the selected electrode in units of Voltage or Current, matching the Stimulation “Control Units” setting.

Sensory

Stimulation Mode

Output On

Press front-panel or on-screen Start Button or depress Footswitch:

Stimulation output is delivered t the selected electrode or bip electrode pair.

olar

creen Press front-panel or on-s Stop Button, release Footswitch, or error occurs:

Electrode output is turned off.

Settings Panels:

Lists the current Stimulation settings.

Press a Settings

Panel button

Stimulation Settings

Section 9.1.2

• Change settings associated with the target Settings Panel

Start/Stop Button: Press “Start” to turn electrode output on. Press “Stop” to turn electrode output off.

Control Units &

Auto Ramp Settings

Impedance Tone: Muted when electrode out

ut is on.

Mode Bar: Access

other procedure screens

Impedance reading: Held at pre-output on value (gray color) when Stimulation output is on. Reads “--- ” when Impedance greater than 3000  (open circuit).

Temperature reading: Reads “-- °C” when Temperature is less than 10°C or absent. Only shown for the selected electrode.

Sensory Pulse Rate

Setting

Sensory Pulse Width

Setting

Section 9

Page 43

Cosman G4 Radiofrequency Generator Service Manual (SPI 11291 Rev A)

Units= Current

9.1.1 Additional Example Screens

The One Touch Stimulation screen will appear differently depending on the current settings:

• Electrode Setup settings (see Section 7.1)

• Stimulation Mode: Sensory or Motor

• Auto Ramp Setting: Off/Manual or On/Auto (see Section 9.1.2)

• Control Units setting: Voltage- or Current-controlled output (see Section 9.1.2)

Motor Mode

Indicator

Motor Stimulation

Mode

Three Electrodes

Electrode Panel (Black area):

Displays all readings for the indicated bipolar electrode pair, e.g. “Electrode 1+2”.

Sensory

Stimulation Mode

Two Bipolar Pairs

Bipolar readings: Voltage/Current and Impedance between the two electrodes in the bi

olar pair

Sensory

Stimulation Mode

One Electrode,

uto Ramp = On &

Mode: Select Sensory or Motor Stimulation output

Settings Panels: Mode switches between Sensory & Motor settings

Temperature Readings: One Temperature reading from each electrode in bipolar pair. For instance, “E1” indicates a reading from Electrode 1.

Electrode Select Buttons: Select between bipolar electrode pairs 1+2 or 3+4.

uto Ramp & Units

Indicator: Reads “Auto” if

uto Ramp=On, and “Manual” otherwise. Reads “Voltage” or “Current” to match the Control Units setting.

Output Level Reading: Shown here in units of Current (mA). This is determined by the Control Units = Current.

Electrode Select Buttons:

bsent when Electrode Setup for one electrode or one bipolar pair.

Output Increment & Decrement Buttons:

bsent if Auto Ramp = On.

Section 9

Page 44

Cosman G4 Radiofrequency Generator Service Manual (SPI 11291 Rev A)

9.1.2 Stimulation Settings

The Electrode Setup settings (Section 7.1) determine the configuration of electrodes when the generator delivers Sensory and Motor Stimulation output. The "Electrode Select Buttons" on the Stimulation screen (see Section 9.1) are used to select one electrode at a time, or one bipolar electrode pair at a time, from those set as "active" on the Electrode Setup screen. Stimulation output is delivered only to the one selected electrode or bipolar electrode pair. The following settings determine the Stimulation output characteristics.

• Control Units (“Units”):

• Voltage: Sensory and Motor Stimulation output is Voltage-regulated.

• Current: Sensory and Motor Stimulation output is Current-regulated.

• Auto Ramp:

• Off: The Sensory and Motor Stimulation output level is controlled manually by the on-screen

Output Increment and Decrement buttons (One Touch interface only).

• On: The Sensory and Motor Stimulation output level increases automatically after the user

has turned the output on.

• Sensory Pulse Rate (“Pulse Rate”): The rate of Sensory Stimulation output pulses in units of Hertz

(Hz), which is equivalent to units of “Pulses Per Second”.

• Sensory Pulse Width (“Pulse Width”): The width of Sensory Stimulation output pulses in units of

milliseconds.

• Sensory Auto Ramp Max: The maximum output level if Auto Ramp = On.

• Motor Pulse Rate (“Pulse Rate”): The rate of Motor Stimulation output pulses in units of Hertz

(Hz), which is equivalent to units of “Pulses Per Second”.

• Motor Pulse Width (“Pulse Width”): The width of Motor Stimulation output pulses in units of

milliseconds.

• Motor Auto Ramp Max: The maximum Motor Stimulation output level if Auto Ramp = On.

An example of a Stimulation Change Settings screen is shown below.

Select settings from buttons sets

Custom Setting Keypad

Select “Custom” from a setting button set

Stimulation Screen

Press “Ok”:

ccept selected

settings.

Section 9.1

Section 9

Page 45

Cosman G4 Radiofrequency Generator Service Manual (SPI 11291 Rev A)

)

9.2 Thermal RF Screen

Electrode Panel (Black area):

Displays all readings for the indicated electrode output. When enabled, RF output is delivered to this output.

Output Off

Indicator

Standard

Mode

Output Off

Impedance

Readin

Timer: Holds value from

last instance of Thermal RF output.

Personal Settings Preset

Indicato

Electrode Setup Indicator

(Section 7.1)

Screen Shot Button: Save an image of the screen to the Procedure Record.

Start/Stop Button: Press “Start” to turn electrode output on. Press “Stop” to turn electrode output off.

Mode: Select Standard or Stepped control mode

Settings Panels: Lists the current Thermal RF settings.

Mode Ba

other procedur screens

Timer: Counts up to Set

Temp in Minutes and Seconds (min:sec) w RF output is on.

Temperature reading: Reads “-- °C” when Temperature is less than 10°C or absent.

RF Voltage Reading: In units of RMS Volts.

: A

ccess

hen

Standard

Mode

Output On

RF Current Reading: In units of RMS Milliamps.

Press front-panel or on-screen Start Button or depress Footswitch: Thermal RF output

is delivered to all active electrodes.

Press front-panel or on-screen Stop Button, release Footswitch, timed output completes, or error occurs: Electrode output is

turned off.

Press a Settings

Panel button

Thermal RF Settings

Section 9.2.2

• Change settings associated with the target Settings Panel

Start/Stop Button: Press “Start” to turn electrode output on. Press “Stop” to turn electrode output off.

Impedance reading:

• Held at latest value (gray color) when during Stagger S Reads “

• --- ” when Impedance greater than 3000  (open circuit

tart.

RF Power Reading: In units of RMS Watts.

Section 9

Page 46

Cosman G4 Radiofrequency Generator Service Manual (SPI 11291 Rev A)

9.2.1 Additional Example Screens

The One Touch Thermal RF screen will appear differently depending on the current settings:

• Electrode Setup settings (see Section 7.1)

• Thermal RF Mode: Standard or Stepped (see Section 9.2.2)

Stepped Mode

Four Electrodes

Settings Panels: Lists the current Thermal RF settings for Stepped mode.

Electrode Panel (Black area):

Displays all readings for the indicated bipolar electrode pair, e.g. “Electrode 1+2”.

Standard Mode

One Bipolar Pair

Bipolar readings: Voltage, Current, Power, and Impedance between the two electrodes in the bi

olar pair

Standard Mode

One Electrode

Temperature Readings: One Temperature reading from each electrode in bipolar pair. For instance, “E1” indicates a reading from Electrode 1.

Section 9

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Cosman G4 Radiofrequency Generator Service Manual (SPI 11291 Rev A)

9.2.2 Thermal RF Settings

• Mode:

• Standard: Time and Temperature control for the Thermal RF output is determined by the Auto

Ramp, Set Temp, and Set Time settings.

• Stepped: Time and Temperature control for Thermal RF output is determined by the Start Temp,

• Stagger Start: When using multiple electrodes, electrodes will turn on sequentially from low to high

index, spaced in time by this setting value.

• 0 seconds: All electrodes are energized simultaneous when the user enables Thermal RF

output using the front-panel Start button.

• 5-30 seconds: After the user enables Thermal RF output using the front-panel Start button, each

electrode is not energized until Stagger Start seconds after the previous, lower-indexed electrode is energized.

The following settings apply only when Thermal RF Mode = Standard.

• Auto Ramp: This setting cannot be set by the user in the One Touch interface. It is implicitly set to

On at all times, except when Automatic Temperature Control is disabled (Set Temp = Off), in which case it is set to Off and the Thermal RF output Voltage must be controlled manually by the user with the Output Control Knob.

• Set Temperature (“Set Temp”):

• Off: Automatic Temperature Control is disabled. The generator will not control the Temperature

• 37-90 °C: Automatic Temperature Control enabled. Thermal RF output is automatically adjusted

to target the Set Temp value for each electrode.

• Set Time: This setting determines the total amount of time that Thermal RF output is delivered to

each electrode. Once this time interval has elapsed for each electrode, electrode output is disabled automatically.

Section 9

Page 48

Pulsed RF Screen

)

Electrode Panel (Black area):

Displays all readings for the indicated electrode output. When enabled, RF output is delivered to this output.

Output Off

Indicator

E-dose =

Vary Voltage

Output Off

Impedance

Readin

Cosman G4 Radiofrequency Generator Service Manual (SPI 11291 Rev A)

Timer: Holds value from

last instance of Pulsed RF output.

Personal Settings Preset

Indicato

Electrode Setup Indicator

(Section 7.1)

Screen Shot Button: Save an image of the screen to the Procedure Record.

Start/Stop Button: Press “Start” to turn electrode output on. Press “Stop” to turn electrode output off.

Settings Panels: Lists the current Pulsed RF settings.

Mode Ba

other procedur screens

Time

Temp in Minutes and Seconds (min:sec) w RF output is on.

Temperature reading: Reads “-- °C” when Temperature is less than 10°C or absent.

RF Voltage Reading: In units of Peak Volts.

: A

ccess

: Counts up to Set

hen

E-dose =

Vary Voltage

Output On

Impedance reading:

• Held a latest value (gray color) when during Stagger S Reads “

• --- ” when Impedance greater than 3000  (open circuit

tart.

RF Current Reading: In units of Peak Milliam

Press front-panel or on-screen Start Button or depress Footswitch: Pulsed RF output

is delivered to all active electrodes.

Press front-panel or on-screen Stop Button, release Footswitch, timed output completes, or error occurs: Electrode output is turned off.

Press a Settings

Panel button

Pulsed RF Settings

Section 9.2.4

• Change settings associated with the target Settings Panel

Start/Stop Button: Press “Start” to turn electrode output on. Press “Stop” to turn electrode output off.

Set Voltage &

E-dose Settings

Pulse Rate,

Pulse Width &

E-dose Settings

Section 9

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Cosman G4 Radiofrequency Generator Service Manual (SPI 11291 Rev A)

9.2.3 Additional Example Screens

The One Touch Pulsed RF screen will appear differently depending on the current settings:

• Electrode Setup settings (see Section 7.1)

• E-dose setting: Vary Voltage, Vary Width, or Vary Rate (see Section 9.2.4)

Pulse Width Reading:

E-dose = Vary Width

Four Electrodes

Displayed in units of milliseconds only if E-dose = Vary Width. The Pulse Ra is fixed at the value shown in the Settings Panel.

Electrode Panel (Black area):

Displays all readings for the indicated bipolar electrode pair, e.g. “Electrode 1+2”.

E-dose = Vary Voltage

One Bipolar Pair

Bipolar readings: Voltage, Current, and Impedance between the two electrodes in the bi

olar pair

E-dose = Vary Rate

One Electrode

Pulse Panel: If E-dose = Vary Width, the Pulse Width and Pulse Rate are fixed at the values shown here.

Temperature Readings: One Temperature reading from each electrode in bipolar pair. For instance, “E1” indicates a reading from Electrode 1.

Pulse Rate Reading: Displayed in units of Hertz only if E-dose = Vary Rate. The Pulse Width is fixed at the value shown in the Settings Panel.

Section 9

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Cosman G4 Radiofrequency Generator Service Manual (SPI 11291 Rev A)

9.2.4 Pulsed RF Settings

• Stagger Start: When using multiple electrodes, electrodes will turn on sequentially from low to high

index, spaced in time by this setting value.

• 0 seconds: All electrodes are energized simultaneous when the user enables Pulsed RF output

using the front-panel Start button.

• 5-30 seconds: After the user enables Pulsed RF output using the front-panel Start button, each

electrode is not energized until Stagger Start seconds after the previous, lower-indexed electrode is energized.

• Auto Ramp: This setting cannot be set by the user in the One Touch interface. It is implicitly set to

On at all times, except when Automatic Temperature Control is disabled (Max Temp = Off), in which case it is set to Off and the Pulsed RF output Voltage must be controlled manually by the user with the Output Control Knob.