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Cosman G4 - User Manual

Cosman G4
115 pages
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DATE
11/7/2008
STANDARD PROCEDURE INSTRUCTIONS
SPI #
11291
REV.
A
SUPERSEDES
N/A
COSMAN MEDICAL, INC
PAGE 1 of 115
DO NOT ISSUE REV
SHEET
G4 Service Manual
ECO # REVISION DESCRIPTION
Eng. Draft 1 Version for initial product release.
Prepared by:____________________________ Date: ____________
Approved by: ___________________________ Date: ____________
Manufacturing
Approved by: ___________________________ Date: ____________
Engineering
Approved by: ___________________________ Date: ____________
Quality and Regulatory Affairs
Approved by: ___________________________ Date: ____________
Management

Table of Contents

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Summary

General Information

Device Classification

Classifications per EN 60601-1.

Electrical Safety and EMC Standards

Compliance with electrical safety and EMC standards.

General Safety Warnings

Critical safety warnings for operating the device.

Electrical Safety Information

Detailed electrical safety information and precautions.

Operational Safety Precautions

Warnings and precautions for safe operation and patient care.

Key to Device Markings

Explains device symbols, controls, and connections.

Mains Power Controls

Identifies mains power on/off switches.

Output Control Elements

Describes start, stop buttons, and output control knob.

Output Connection Ports

Details electrode and reference ground pad connection ports.

Other Device Connections and Indicators

Identifies connections, readings, and status indicators.

Certifications and Unit Identification

Lists device certifications, compliance, and identification symbols.

Chassis Layout

Front Panel Layout

Identifies and describes components on the front panel.

Back Panel Layout

Identifies and describes components on the back panel.

Getting Started

System Description

Overview of the G4 lesion generator capabilities.

Indications for Use

Specifies the intended uses of the G4 generator.

Unpacking the G4 System

Lists G4 system components and unpacking notices.

Turning on the G4 & Main Menu

Startup and Main Menu Flow

Describes the sequence of screens from startup to main menu.

System Setup

Date, Time, Language, and Audio Volume

Configuration of system date, time, language, and audio settings.

Touch Screen Calibration

Procedure for calibrating the touch screen interface.

Testing the G4 Unit

Procedures for testing the G4 unit functionality.

Error and Warning Dialogs

Explains error messages and common error conditions.

Start Procedure Screen

Procedure Initiation and Presets

Details starting a procedure and managing presets.

Electrode Setup Screen

Electrode Configuration and Labeling

Setting up electrodes, assigning labels, and understanding the interface.

Electrode Setup Settings

Determines RF type, active electrodes, and labels.

Graphing Interface

Interface Overview and Features

Details distinguishing characteristics and functions of the Graphing interface.

Stimulation Screen

Explains Stimulation screen, controls, and readings.

Stimulation Settings

Configures control units, auto ramp, and pulse parameters.

Thermal RF Screen

Details Thermal RF screen, including timer, set temp, and output controls.

Thermal RF Settings

Configures mode, stagger start, auto ramp, set temp, and set time.

Pulsed RF Screen

Details Pulsed RF screen, including timer, E-dose, and output controls.

Pulsed RF Settings

Configures stagger start, auto ramp, E-dose, and pulse parameters.

One Touch Interface

Interface Overview and Controls

Details distinguishing features of the One Touch interface.

Stimulation Screen

Explains One Touch stimulation controls, modes, and readings.

Stimulation Settings

Configures control units, auto ramp, and pulse parameters in One Touch.

Thermal RF Screen

Explains One Touch Thermal RF controls, modes, and readings.

Thermal RF Settings

Configures mode, stagger start, auto ramp, and temperature settings.

Pulsed RF Screen

Explains One Touch Pulsed RF controls, E-dose, and output.

Pulsed RF Settings

Configures stagger start, auto ramp, E-dose, and pulse parameters.

Sterilization, Care, and Service

Sterilization Procedures

Recommended methods for sterilizing specific components.

Cleaning and Care Instructions

Guidelines for cleaning the generator and accessories.

Service and Fuse Replacement

Information on servicing, testing, and fuse replacement.

Troubleshooting

Common Problems and Solutions

Identifies issues and their potential causes for troubleshooting.

Specifications

Electrical Supply and Environment

Details voltage, power, environmental operating and storage conditions.

Output and Monitor Specifications

Specifies impedance, stimulator, and RF output characteristics.

Output Power Curves

Power vs. Knob Setting

Graph showing output power relative to knob setting across resistances.

Power vs. Resistance

Graph showing output power relative to resistance for half and full output.

Accessories

Accessory Part List

Lists part numbers and descriptions for available accessories.

Test Equipment

Required Test Equipment

Lists all test equipment necessary for system maintenance.

System Testing

Application Program Check

Verifies that the application program files are loaded correctly.

Low Voltage Oscillator Resonance Check

Tests the oscillator resonance using specific loads and oscilloscope.

Touch Screen Display Test

Verifies the functionality and display of the touch screen.

Temperature Display Calibration

Calibrates temperature display accuracy using water baths.

High Voltage Measurement Calibration

Calibrates high voltage measurement accuracy using oscilloscope.

Peak Voltage Display Calibration

Calibrates peak voltage display accuracy using oscilloscope.

Off Zero Lockout Test

Verifies the lockout functionality when output is turned off.

Display Checks

Verifies accuracy of voltage, current, and wattage displays.

Lesion Timer Test

Tests the functionality of the lesion timer.

Automatic Temperature Control Test

Verifies the automatic temperature control feature.

Temperature Variation with Cables

Checks temperature variation with different cables and output levels.

Impedance Variation with Cables

Verifies impedance stability across output levels with cables.

Impedance Range Tests

Tests impedance readings at different output levels and configurations.

No Temperature Lock-out Test

Verifies the system behavior when temperature measurement is off.

Audio Calibration Adjustment

Calibrates the audio volume and frequency response.

Stimulator Tests

Verifies stimulator output parameters like voltage, current, rate, and duration.

Maximum RF Output Test

Tests the maximum RF output voltage.

Electrical Safety Tests

HIPOT Testing

Performs high potential (HIPOT) tests for insulation integrity.

Leakage Testing

Measures AC mains and patient leakage currents.

Ground Bond Test

Tests the integrity of the protective earth ground connection.

Final Check Out

Pre-shipment Inspection and Configuration

Final visual inspection, functional checks, and voltage configuration.

System Diagram

System Block Diagram

Illustrates the main components and their interconnections.

Schematic Drawings

Backplane Board Assembly Schematic

Detailed schematic diagram of the backplane board.

RMS Stim Board Assembly Schematic

Detailed schematic diagram of the RMS Stim board.

Current Board Assembly Schematic

Detailed schematic diagram of the Current board.

USB Card Board Assembly Schematic

Detailed schematic diagram of the USB Card board.

Power Supply Board Assembly Schematic

Detailed schematic diagram of the Power Supply board.

PC Board Assemblies

Backplane Board Assembly Part Placement

Shows component placement on the topside of the backplane board.

RMS Stim Board Assembly Part Placement

Shows component placement on the topside of the RMS Stim board.

Current Board Assembly Part Placement

Shows component placement on the Current board.

USB Card Board Assembly Part Placement

Shows component placement on the USB Card board.

Power Supply Board Assembly Part Placement

Shows component placement on the topside of the Power Supply board.

Part Lists

Backplane Board Assembly Parts

Lists all components for the backplane board assembly.

RMS Stim Board Assembly Parts

Lists all components for the RMS Stim board assembly.

Current Board Assembly Parts

Lists all components for the Current board assembly.

USB Card Board Assembly Parts

Lists all components for the USB Card board assembly.

Power Supply Board Assembly Parts

Lists all components for the Power Supply board assembly.

Data Sheet and Certificate of Conformance

Test Results Summary

Records results for initial display, touch screen, RF output, and lesion timer tests.

Safety Testing Results

Records results for Hipot, leakage, and ground bond tests.

Cosman G4 Specifications

General IconGeneral
Engine Type4-Stroke OHV
Engine Displacement212cc
Fuel Tank Capacity4 Gallons
Noise Level68 dB
Starting MethodRecoil Start