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LORAD AFFINITY Series User Manual

LORAD AFFINITY Series
214 pages
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Form ENG-0034-T03, Rev. 001
Osteoporosis Assessment
LORAD
©
Breast Cancer Detection
DirectRay
©
Digital Imaging
FLUOROSCAN
©
C -arm Imaging
TITLE DOCUMENT NUMBER REV
MANUAL, AFFINITY
SERVICE
AW-00227 005
ARTWORK SIZE A SHEET 1 OF 1
REV AUTHORED BY DATE
A. TAMBASCIO 7/24/2003
REV DRAFTED BY DATE
BILL MOSES 8/5/2003
PROPRIETARY: This document contains
proprietary data of Hologic, Inc. No
disclosure, reproduction or use of any
part thereof may be made except by
written permission from Hologic.
REV. RELEASE DATE:
8/14/03
3
Artwork and Signature File for:
9-500-0255 MANUAL, AFFINITY SERVICE
Artwork consists of:
Two hundred and twelve (212) 8 ½ inch x 11 inch pages.

Table of Contents

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LORAD AFFINITY Series Specifications

General IconGeneral
BrandLORAD
ModelAFFINITY Series
CategoryMedical Equipment
LanguageEnglish

Summary

Preface

Using the Service Manual

Guidance on how to effectively use the Affinity Series Service Manual for optimal results.

Warnings, Cautions and Notes

Definitions of important safety alerts, cautions, and notes used throughout the manual.

Acronym List

A comprehensive list of common acronyms used in the Affinity Series Service Manual.

Chapter 1: General Information

Introduction

Overview of the LORAD Affinity mammography system, its features, and intended uses.

Required Tools and Equipment

Lists the essential tools and equipment required for installation and maintenance of the Affinity System.

Safety Precautions

Details electrical, mechanical, and radiation safety measures, including hazardous material warnings.

Interlocks

Describes the various safety interlocks incorporated into the Affinity Series system to prevent hazardous operation.

Mechanical Safety

Outlines mechanical safety compliance requirements and conditions for the equipment.

Radiation Safety

Details radiation safety compliance, exposure duration limits, and protective measures.

Unit Description

Provides a description of the Affinity Series major hardware components: Gantry, C-arm, and Control Panel.

Control Panel Overview

Describes the Affinity Series Control Panel, its interface, and its function in setting techniques and parameters.

Compliance Data

Details the system's compliance with FDA regulations and various safety standards.

Certifiable Components

Lists the certifiable components of the LORAD unit, identified by serial numbers.

Location of Labels

Illustrates the location of compliance labels and nameplates on the Affinity Series mammography unit.

Chapter 2: System Installation

Room Planning

Guidelines for planning the exam room layout, considering clearances, space, and power requirements.

Unpacking Instructions

Detailed procedures for receiving and unpacking the Affinity Series Mammography Unit.

Unit Installation

Provides a sequence of steps for setting up, positioning, and installing the Affinity Series unit.

Input Power Configuration

Details configuring the isolation transformer to match the site's power source and verifying voltage.

Power Cable Connection

Instructions for hardwiring the power cord into the power source, requiring a certified electrician.

Remote X-ray ON/Power ON Light Connection

Describes connecting remote lights to indicate system status (ON and X-ray in use).

Control Panel Installation

Procedures for installing the Control Panel, either mounted to the Gantry or remotely.

Securing Unit in Position

Steps for securing the unit in its final designated position and mounting it to the floor.

Installing the Unit Accessories

Instructions for installing essential unit accessories like footswitches and film labeling devices.

Initial Start Up Procedures

Steps for initial power up, including configuration of remote lights and system checks.

Setting Operational Parameters

Procedures for setting user defaults, calibrations, performance checks, and alignment.

Final Operational Setup

Final steps to ready the system for operation, including replacing covers and panels.

Installing the Radiation Shield

Detailed instructions for mounting the radiation shield to the Gantry for operator protection.

Chapter 3: Functional Checks/Setting Defaults

Controls and Indicators

Identifies and locates the Affinity Series controls and indicators used throughout the chapter.

System Power Up

Procedures for performing pre-power up checks and verifying the power up sequence.

Post Power-Up Checks

Checks to determine if electro-mechanical subsystems are functioning correctly after power application.

The Affinity Series Control Panel

Details the Affinity Series Control Panel, its interface, and its function in setting techniques and system settings.

Control Panel Screens

Describes the different user mode screens: Run Mode, User Default, Exposure Default, and Calibration screens.

Setting User Defaults

Guidance on setting machine parameters like compression release, force units, and date/time.

Setting Exposure Technique Defaults

Instructions for setting default exposure modes, kV, mAs, and filter settings via the Exposure Default Screen.

Chapter 4: Calibrations and Performance Checks

Introduction

Overview of calibration, adjustment, and performance/compliance check procedures.

Calibration Procedures

Steps to set up, check, and calibrate the exposure generating system and related subsystems.

Entering Calibration Mode

Procedure to access the Affinity Series calibration screens by setting DIP switches and navigating menus.

Compression System Calibration Procedures

Procedures for calibrating the compression force and compression thickness sensing circuits.

Exposure System Calibration

Details procedures to calibrate the exposure-generating system, including tube voltage and mA.

Automatic Exposure Control System Calibration

Steps to calibrate the Automatic Exposure Control (AEC) system for proper performance and optical density.

Performance Checks

Procedures to verify system performance, including checks for X-ray generation, shielding, and leakage.

Half-Value Layer

Compliance check to verify X-ray beam quality and half-value layer requirements.

Reproducibility and Linearity in Manual Mode

Test to verify consistent X-ray system operation and linearity in manual exposure mode.

Bucky Device Performance Check

Check performed before using new Bucky devices to ensure absence of grid lines or patterns on film.

X-ray and Light Field Check and Alignment Procedures

Procedures to ensure alignment of X-ray and light fields within specified limits for optimal image quality.

Mechanical Adjustments

Details mechanical adjustments that may be required after servicing the compression system.

Chapter 5: Maintenance—General

Introduction

Provides general information to aid Service Engineers in maintaining the Affinity.

Preventive Maintenance

Details recommended preventive maintenance procedures and inspection points for the Affinity System.

Troubleshooting

Overview of system theory, alert codes, and resources for troubleshooting the Affinity.

Theory of Operation Overview

Provides a high-level description of system and sub-system operation to aid service engineers.

Alert Codes Log

Lists alert codes, their messages, and comments for identifying malfunctions and troubleshooting.

System Data Retrieval

Explains how to download/upload calibration data and alert logs to a laptop computer for analysis.

Chapter 6: Maintenance—Remove and Replace Procedures

Introduction

Details removal and replacement procedures for Affinity components, with references for alignment.

Gantry Components—Remove and Replace

Provides procedures for removing and replacing components located within the Gantry.

Removing Covers and Panels From the Gantry

Instructions for removing various covers and panels to gain access to the interior of the Gantry.

Left and Right Side Panels

Procedure for removing the left and right side Gantry panels to access internal electronics.

C-arm Components—Remove and Replace

Details removal and replacement procedures for components located within the C-arm Frame.

Tubehead Components

Procedures for removing and replacing components within the tubehead assembly.

Compression Assembly

Details the removal and replacement procedures for components making up the Compression Assembly.

IRSD Components

Details removal and replacement procedures for components located inside the Image Receptor Support Device (IRSD).

Chapter 7: Parts List

Instructions

Provides guidance on using the tabular listings of serviceable components for the Affinity.

The Replacement Parts Lists

Lists the different replacement parts lists available for the Affinity, organized by system component.

Appendix A: Specifications

System Specifications

Details electrical input specifications, unit measurements, operating, and storage environment requirements.

C-arm Specifications

Provides specifications for C-arm rotation, vertical travel, alignment, and source-to-image distance.

Compression Specifications

Details specifications for manual and motorized compression force, release, and measurement.

Compression Paddles

Describes the properties and available sizes of the compression paddles used with the system.

Apertures

Lists the six available apertures for various paddle and receptor combinations.

X-ray Source, Filtration and Collimation

Provides specifications for the X-ray tube, focal spot, voltage, filtration, and collimation.

High Voltage Generator Specification

Details specifications for the High Voltage Generator, including output, ripple, topology, and mAs ranges.

Appendix B: Technical References

Introduction

Introduces tables for identifying test points, LEDs, fuses, jumpers, and sensor combinations.

Test Points

Provides tables of test points for various boards, including voltage/signal and function details.

LED Indicators

Tables listing LED indicators on various boards, their functions, and the conditions under which they light up.

Image Receptor Detect Board—Sensor Combinations

Details sensor combinations for image receptors, used to identify installed holders and their HEX codes.

Fuses

Lists fuse locations, part numbers, descriptions, and ratings for the Affinity Series Gantry circuit boards.

Jumpers

Shows jumper configurations on Affinity boards, including default settings and functions for testing or calibration.