• Topic ID: id_17423104
  • Version: 2.0
  • Date: Nov 20, 2019 9:49:02 PM

Certified Component Replacement Retest Matrix

1 Introduction

These procedures apply to Optima CT620 system.

This document defines the minimum retest requirements when a certified component is replaced or swapped on a CT System. The primary function of this document is to ensure that the replaced certified component functions correctly as designed in the system.

The tests described in this document can be found in the Service Installation Manual and in the service replacement procedures. Use Certified Component Verification Form e4879 as a checklist when performing these retest activities.

1.1 Component Removal

Follow the CT System De-Installation for the CT family to de-install these components:

  • Gantry
  • Table
  • Console
  • PDU
  • UPS

Follow the instructions in the replacement procedures to remove these components:

  • X-Ray Tube
  • Collimator
  • High Voltage Generator

1.2 Certified Components

Certified components as defined by the FDA & GE Healthcare:

  • Collimator Assembly

  • X-Ray Tube

  • High Voltage Generator, which includes

    • Auxiliary Box

    • Power Unit

    • HV Tank

    • HEMIT Tank

  • Gantry (replacement)

  • Console Master Control (replacement)

  • Table (replacement)

2 CT Gantry Replacement

note: Gantry replacement requires two people to complete, which can be accomplished in one day.

Before you start:

  1. Locate the CT System De-Installation for CT Family. Follow the Gantry Removal section to de-install this component.

  2. Record all required information and data from the system prior to powering down.

    note: Do not cut or damage cables when removing.

  3. Complete a system save state.

  4. Follow the delivery procedures in the installation manual shipped with your system.

2.1 Installation Instructions Book 1

Review/complete only these sections in the installation manual shipped with your system.

2.1.1 Chapter 1 Mechanical – Position Subsystems:

  • Removing Gantry Dollies and Covers

  • Installation Conditions

  • Position the Gantry

  • Level the Gantry

  • Gantry Cover Removal

  • Gantry Bearing Gap Inspection

  • Install Gantry Alignment Laser and Bracket or Install Alignment Bars

  • Gantry Tilt Zero Alignment Check

  • Cradle/Table Parallel Check

  • Tighten the Lock Rings

  • Drill the Table Anchor Holes

  • Gantry & Table Alternate Anchor Holes

  • Install the Anchors

  • Alignment Recheck

  • Remove Gantry Tilt Bracket

2.1.2 Chapter 2 – Mechanical – Power, Ground & Interconnect Cables:

Gantry Cable Connections

2.1.3 Chapter 3 – Mechanical – System Continuity & Ground Checks:

  • System Continuity

  • Site Ground Continuity Check

2.1.4 Chapter 4 or Appendix A:

  • Removal & Installation of Covers

  • Gantry Cover Alignment Adjustment Guide

  • Gantry Base Cover Installation

  • Electrical Power On & Ground Checks: System Power-Up

2.2 Installation Instructions Book 2

Complete only these sections in the installation manual shipped with your system.

2.2.1 Chapter 6 – Electrical Integration and Safety Verifications

  • Computer Integration and Configuration: Restore System State

  • Table Gantry Integration:

    • Check Alignment Lights

    • CT System X-Ray ON Indicators, Cautions & Warning Labels

    • Check Warning Labels

    • Process Product Locator Cards

    • Check X-Ray Lights

    • Mechanical Characterization

    • Interference Test

    • Verify Table Elevation

    • System Current Leakage Test

2.2.2 Chapter 7 – Image Quality

  • Tube Warm Up and Fast Cal

  • Center Phantom

  • Tomographic Plane Indication

  • Image Quality Test

2.2.3 Finalization:

  • System Functional Test

  • Save System State

  • Cleanup and Return:

    1. Reassemble the removed gantry including replacing covers.

    2. Using the shipped packaging, return all unused parts.

    3. Arrange for transportation to pick up the gantry and any additional parts.

2.2.4 Leakage Test:

  • Patient Touch Leakage Test (all systems)

  • CT Power and Ground Audit (all systems)

  • CT System Chassis Leakage Test (as required in your area)

2.2.5 Forms:

  1. Complete GE e4879 for certified components replacement. Download from SIMS Content Viewer.

  2. Complete FDA e2579. Download from the HHS web.

  3. Verify gantry has GE rating plate and matching ICD cards.

  4. Update GIB.

  5. Email all forms to the HHS administrator.

3 CT Table Replacement

note: Table replacement requires two people to complete, which can be accomplished in one day.

Before you start:

  1. Locate theCT System De-Installation for the CT family. Follow the Table Removal section to de-install this component.

  2. Record all required information and data from the system prior to powering down.

    note: Do not cut or damage cables when removing.

  3. Complete a system save state.

  4. Follow the delivery procedures in the installation manual shipped with your system.

3.1 Installation Instructions Book 1

Review/complete only these sections in the installation manual shipped with your system.

3.1.1 Chapter 1 Mechanical - Position Subsystems:

  • Removing Table Dollies and Covers

  • Installation Conditions

  • Position the Table

  • Install Gantry Alignment Laser and Bracket or Install Alignment Bars

  • Level and Center the Table to the Gantry

  • Table Gantry Mechanical Adjustments (as required for your system)

  • Tighten the Lock Rings (as required for your system)

  • Drill the Table Anchor Holes

  • Table Alternate Anchor Holes

  • Install the Anchors (follow instruction for your system)

  • Alignment Recheck

  • Remove Table Dollies

  • Install Foot Switch Assembly (follow instruction for your system)

3.1.2 Chapter 2 – Mechanical – Power, Ground & Interconnect Cables:

Table Cable Connections

3.1.3 Chapter 3 – Mechanical – System Continuity & Ground Checks:

  • System Continuity

  • Site Ground Continuity Check

  • Install Footswitch Assembly

  • Installation of all table covers and removed gantry covers.

3.2 Installation Instructions Book 2

Complete only these sections in the installation manual shipped with your system.

3.2.1 Chapter 6 – Electrical Integration and Safety Verifications:

  • Electrical Power On & Ground Checks – System Power-Up

  • Computer Integration and Configuration – Restore System State

  • Table Gantry Integration:

    • Check Alignment Lights

    • CT System X-Ray ON Indicators, Cautions & Warning Labels

    • Process Product Locator Cards

    • Check X-Ray Lights

    • Mechanical Characterization

    • Interference Test

    • Verify Table Elevation

    • System Current Leakage Test

3.2.2 Chapter 7 – Image Quality

  • Tube Warm Up and Fast Cal

  • Center Phantom

  • Tomographic Plane Indication

  • Image Quality Test

3.2.3 Finalization:

  • System Functional Test

  • Save System State

  • Cleanup and Return

    1. Reassemble the removed table.

    2. Using the shipped packaging, return all unused parts.

    3. Arrange for transportation to pick up the table and any additional parts.

3.2.4 Leakage Test

  • Patient Touch Leakage Test (all systems)

  • CT Power and Ground Audit (all systems)

  • CT System Chassis Leakage Test (as required in your area)

3.2.5 Forms:

  1. Complete GE e4879 for certified components replacement. Download from SIMS Content Viewer.

  2. Complete FDA e2579. Download from the HHS web.

  3. Verify table has GE rating plate and matching ICD cards.

  4. Update GIB.

  5. Email all forms to the HHS administrator.

4 CT Console Replacement

note: Console replacement requires two people to complete, which can be accomplished in one day.

Before you start:

  1. Locate the CT System De-Installation for the CT family. Follow the Console Removal section to de-install this component.

  2. Record all required information and data from the system prior to powering down.

    note: Do not cut or damage cables when removing.

  3. Complete a system save state.

  4. Check that all network and camera addresses information is present.

  5. Confirm that you have new system options.

  6. Follow the delivery procedures in the installation manual shipped with your system.

4.1 Installation Instructions Book 1

Review/complete only these sections in the installation manual shipped with your system.

note: Do not remove the console from the skid until it is in the control room.

4.1.1 Chapter 1 – Mechanical – Position Subsystems:

  • Installation Console

  • Seismatic

4.1.2 Chapter 2 – Mechanical – Power, Ground & Interconnect Cables:

  • Console Connections

  • Install Options

  • Console Power Connections

  • Ground Connections

4.1.3 Chapter 3 – Mechanical – System Continuity & Ground Checks:

  • System Continuity & Ground Checks

  • Site Ground Continuity Check

  • Installation Completion Section

4.2 Installation Instructions Book 2

Complete only these sections in the installation manual shipped with your system.

4.2.1 Chapter 6 – Electrical Integration and Safety Verifications:

  • Electrical Power On & Ground Checks – System Power-Up

  • Computer Integration and Configuration:

    • Complete a full LFC

    • Complete all remaining sections

  • Table Gantry Integration:

    • Check Alignment Lights

    • CT System X-Ray ON Indicators, Cautions & Warning Labels

    • Process Product Locator Cards

    • Check X-Ray Lights

    • System Current Leakage Test

4.2.2 Finalization:

  • System Functional Test

  • Save System State

  • Cleanup and Return:

    1. Reassemble the removed table.

    2. Using the shipped packaging, return all unused parts.

    3. Arrange for transportation to pick up the table and any additional parts.

4.2.3 Leakage Test

  • Patient Touch Leakage Test (all systems)

  • CT Power and Ground Audit (all systems)

  • CT System Chassis Leakage Test (as required in your area)

4.2.4 Forms:

  1. Complete GE e4879 for certified components replacement. Download from SIMS Content Viewer.

  2. Complete FDA e2579. Download from the HHS web.

  3. Verify console has GE rating plate and matching ICD cards.

  4. Update GIB.

  5. Email all forms to the HHS administrator.

5 Collimator Replacement

5.1 Procedure

Follow the Collimator Replacement procedure to replace this component.

5.2 Forms:

  1. Complete GE e4879 for certified components replacement. Download from SIMS Content Viewer.

  2. Complete FDA e2579. Download from the HHS web.

  3. Verify collimator has GE rating plate and matching ICD cards.

  4. Update GIB.

  5. Email all forms to the HHS administrator.

6 High Voltage Generator Replacement Forms

6.1 Procedure

Follow the High Voltage Generator Replacement procedure to replace this component.

note: High Voltage Generator includes Auxiliary Box, Power Unit, HV Tank and HEMIT Tank.

6.2 Forms:

  1. Complete GE e4879 for certified components replacement. Download from SIMS Content Viewer.

  2. Complete FDA e2579. Download from the HHS web.

  3. Verify high voltage tank has GE rating plate and matching ICD cards.

  4. Update GIB.

  5. Email all forms to the HHS administrator.

7 Tube Replacement Forms

7.1 Procedure

Follow the Tube Replacement procedure to replace this component.

7.2 Forms:

  1. Complete GE e4879 for certified components replacement. Download from SIMS Content Viewer.

  2. Complete FDA e2579. Download from the HHS web.

  3. Verify Tube has GE rating plate and matching ICD cards.

  4. Update GIB.

  5. Email all forms to the HHS administrator.