DEL Medical 8000-EPEXOMNIUM X-Ray User Manual Rev A Aug 2005

August 2005 The information contained in this manual is confidential and proprietary to Del Medical Imaging Corporation. This information is provided only to authorized representatives of Del’s customers solely for the purpose of facilitating the use of Del’s products. No information contained herein may be disclosed to any unauthorized person for any purpose whatsoever without the prior written consent of Del Medical Imaging Corporation. The information in this document is subject to change without notice. Copyright 2005 by Del Medical Imaging Corporation. All rights reserved. DirectRay is a registered trademark of Direct Radiography Corp. This manual was originally written in English in the United States. Printed in the U.S.A. All trademarks, registered trademarks, and product names used within this document are the property of their respective owners. Del Medical Imaging Corporation 11550 W. King Street Franklin Park, IL 60131 USA Tel: (847) 288-7000User Support: (877) 371-4DRC (371-4372) Fax: (781) 280-4788

Federal (USA) Law restricts this device to sale by or on the order of a physician (or properly licensed practitioner).

CAUTION

Attention: Consult Accompanying Documents - As Applicable

Del Medical Systems Group 11550 West King Street Franklin Park, IL 60131-1330 USA www.delmedical.com

Phone:1-847-288-7000 Fax:1-847-288-7011 Toll Free:1-800-800-6006

EPEX/Omniflex IV System User’s Guide

Contents About This Manual Audience ... ix Indications for Use... ix Prerequisites... ix Scope... ix Organization... x Conventions Used in This Manual... xi Chapter 1: Introduction What Is the EPEX/Omniflex IV System?... 1-2 What Is DirectRay?... 1-3 Indications for Use... 1-3 System Functions ... 1-4 System Components ... 1-5 DirectRay Detector/Bucky... 1-6 X-ray Tube and Collimator ... 1-6 Radiographic Table ... 1-6 X-ray Generator ... 1-6 Omniflex IV Overhead Tube Crane... 1-7 DirectRay Console ... 1-7 Output Devices ... 1-8 Image Acquisition... 1-9 Safety and Compliance Information ... 1-10 Safety Precautions... 1-10 General Use Cautions and Warnings ... 1-10 Cleaning Cautions... 1-11 Symbols ... 1-12 United States Federal and State Regulations ... 1-14 IEC Regulations ... 1-15 Canadian Regulations ... 1-15

Contents

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EPEX/Omniflex IV System User’s Guide

Manufacturer’s Responsibility... 1-15 Positive Beam Limitation ... 1-16 Caution Regarding Small-Detail Object Imaging... 1-16 Restrictions on Use ... 1-17 Authorized EU Representatives... 1-17 Chapter 2: Basic Operations Starting Up and Logging On to the System ... 2-2 Step 1: Powering Up the UPS... 2-3 Step 2: Powering Up the X-ray Generator... 2-4 Step 3: Checking the System ... 2-4 Step 4: Powering Up the DirectRay Console CPU... 2-5 Step 5: Logging In to the CPU’s Operating System ... 2-6 Step 6: Signing In to the DirectRay Console Application ... 2-7 Changing Your DirectRay Console User Application Password... 2-8 Warming Up the X-ray Tube ... 2-9 Capturing Images ... 2-11 Overview for Capturing Images ... 2-11 Step 1: Identifying the Patient and Visit ... 2-12 Adding a New Patient Manually... 2-13 Choosing an Existing Patient or Visit Using the Search Function ... 2-15 Choosing a Patient Using the Modality Worklist Query ... 2-21 Scanning a Bar Code to Identify the Patient/Visit/Study... 2-28 Step 2: Choosing Output Destinations... 2-29 Step 3: Adjusting Exposure Settings and the Exposure Sequence (Optional) ... 2-29 Step 4: Adjusting the Orientation of the Table and Bucky ... 2-30 Positioning the Radiographic Table ... 2-30 Positioning the Bucky... 2-31 Step 5: Positioning the X-ray Tube and Collimator... 2-35 Features ... 2-36 Using the Overhead Tube Crane Control Panel to Position the X-ray Tube ... 2-36 Using the Auto Modes to Have the X-ray Tube Track the Bucky ... 2-40

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EPEX/Omniflex IV System User’s Guide

Auto Mode Option ... 2-40 Auto On In Wall Mode ... 2-41 Auto On In Table Mode ... 2-42 Positioning the Overhead Tube Crane for Chest Exposures... 2-43 Positioning the Overhead Tube Crane for Under Table Exposures... 2-44 Adjusting the Collimator ... 2-45 Step 6: Exposing Patients... 2-45 Two-Stage Image Preview ... 2-47 Step 7: Accepting or Rejecting an Image ... 2-47 Rotating or Mirroring the Image (Optional) ... 2-48 Verifying and Correcting Image Laterality and Patient Orientation Settings (Optional)... 2-49 Cropping an Image (Optional) ... 2-49 Selecting the Image Position on a Multiformat Sheet (Optional) ... 2-49 Using True Size Helper (Optional) ... 2-50 Masking an Image (Optional) ... 2-50 Adding Markers to the Image (Optional) ... 2-50 Selecting ESA or IT (Optional) ... 2-50 Changing the Appearance of the Image (Optional) ... 2-51 Adding Comments to an Image (Optional)... 2-51 Accepting the Image ... 2-52 Rejecting the Image ... 2-53 Step 8: Opening an Additional Procedure (Optional)... 2-54 Step 9: Adding a View to a Procedure (Optional) ... 2-54 Step 10: Closing the Study, Visit, and Patient... 2-54 Step 11: Signing Out from an Acquisition Session... 2-55 Switching User Levels ... 2-56 Powering Down the System Components ... 2-57 Recommended Power Down Procedure Overview ... 2-57 Step 1: Powering Down the DirectRay Console CPU ... 2-58 Step 2: Powering Down the X-ray Generator ... 2-59 Step 3: Powering Down the DirectRay Console’s UPS... 2-60

Contents

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EPEX/Omniflex IV System User’s Guide

Chapter 3: Managing the Image Output Queues and Resending Images Overview... 3-2 Managing the Image Output Queues ... 3-3 Resending Images to Output Devices ... 3-6 Repreviewing Images ... 3-10 Chapter 4: Protecting Patient Records Overview... 4-2 Reclamation Strategy ... 4-2 Procedure for Protecting a Patient Record... 4-3 Chapter 5: Maintaining System Components Overview... 5-2 Daily Maintenance ... 5-2 Weekly Maintenance... 5-2 Monthly Maintenance ... 5-3 Cleaning the Equipment... 5-3 Checking the Equipment Integrity ... 5-4 System Periodic Maintenance... 5-4 Replacing the UPS Battery ... 5-5 Reporting Unusual Conditions... 5-5 Calibrating the DirectRay Detector ... 5-6

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Contents

EPEX/Omniflex IV System User’s Guide

Chapter 6: Troubleshooting Overview... 6-2 CPU Problems... 6-3 X-ray Generator Problems ... 6-4 Resetting the X-ray Generator ... 6-4 Console Alarm Messages... 6-5 Troubleshooting Image Problems ... 6-6 Guidelines for Ensuring Good Images... 6-6 Diagnosing and Correcting Image Problems ... 6-7 Miscellaneous Problems ... 6-8 Powering the DirectRay Components On and Off ... 6-9 Loss of Electrical Power ... 6-10 X-ray Generator Error Codes (CPI)... 6-11 Appendix A: Specifications Subsystem Specifications ... A-2 DirectRay Image Capture System... A-2 DirectRay Console ... A-3 Omniflex IV Overhead Tube Crane... A-3 Radiographic Table ... A-4 X-ray Generator ... A-5 Environment... A-6 Transit/Storage ... A-6 Operating ... A-6 Installation Requirements ... A-6 Flooring... A-6 Ceiling... A-6 Glossary

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vii

About This Manual Audience This manual is intended for users of the Del EPEX/Omniflex IV General Radiography System, to acquire medical diagnostic X-ray images. It provides operating instructions for the system.

Indications for Use The EPEX/Omniflex IV System has application whenever DirectRay radiographic images are created, and transmission of these images and related text are required from DirectRay technology to hardcopy, softcopy, or archive. Follow all safety labels on the equipment.

Prerequisites The procedures in this manual assume that you know how to do the following operations related to the system’s graphical user interface: •

Perform mouse and trackball operations, such as click, drag and select

•

Select from menus

•

Click buttons

•

Enter information in text fields

•

Select options

•

Select entries from pop-up or drop-down lists

•

Use scroll bars

Scope This manual contains information about the EPEX/Omniflex IV System and its operational features.

ix

EPEX/Omniflex IV System User’s Guide

Organization This manual is organized into the following chapters and appendices: Chapter 1: Introduction Illustrates and provides a brief overview of the EPEX/Omniflex IV System functions. Chapter 2: Basic Operations Provides basic information about using the EPEX/Omniflex IV System to acquire images and send them to output devices. It also includes procedures for EPEX/Omniflex IV System start-up, shutdown, and X-ray tube warm-up. Chapter 3: Managing the Image Output Queues and Resending Images Describes the procedures for managing the image output queues, resending previously acquired images that are still stored in the system, and repreviewing images that have not been reclaimed. Chapter 4: Protecting Patient Records Explains how to protect patients and their related images from being deleted by the system. Chapter 5: Maintaining System Components Explains how to perform maintenance of the EPEX/Omniflex IV System. Chapter 6: Troubleshooting Explains how to perform basic troubleshooting operations. It identifies and explains how to handle common system problems that do not require service intervention, and provides a listing of system alarms along with the required response actions. Appendix A: Specifications Lists the specifications for the EPEX/Omniflex IV System. A glossary follows Appendix A.

x

About This Manual

EPEX/Omniflex IV System User’s Guide

Conventions Used in This Manual This manual uses three types of special messages to emphasize information or point out potential risks to personnel or equipment. Note: Notes provide additional information, such as expanded explanations, hints, or reminders.

A sample of a note is shown in the margin to the left.

Samples of cautions and warnings are shown below. Cautions point out procedures that you must follow precisely to avoid damage to equipment, loss of data, or corruption of files in software applications.

CAUTION

Warnings point out procedures that you must follow precisely to avoid injury to yourself or others.

WARNING

About This Manual

xi

Chapter 1 Introduction This chapter provides an overview of the EPEX/Omniflex IV System. It includes a general description of the system’s functions and descriptions of each component, as well as a description of possible output devices, optional image acquisition workflows, and Safety and Compliance.

Contents Subject

Page

What Is the EPEX/Omniflex IV System?... 1-2 What Is DirectRay?... 1-3 Indications for Use... 1-3 System Functions ... 1-4 System Components ... 1-5 Image Acquisition... 1-9 Safety and Compliance Information ... 1-10

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EPEX/Omniflex IV System User’s Guide

What Is the EPEX/Omniflex IV System? The EPEX/Omniflex IV System is a complete filmless, computer-controlled radiographic system consisting of: •

Overhead tube crane

•

X-ray Generator

•

Articulating arm and Bucky support

•

Radiographic table

•

X-ray tube and Collimator

•

Bucky and DirectRay® Detector

•

DirectRay Console

DirectRay is technology that optimizes the X-ray information for the highest quality images, without film. For a complete description, refer to the topic “What Is DirectRay?” on page 1-3. The EPEX/Omniflex IV System has been designed for a full range of exams using a single DirectRay Detector. Figure 1-1. EPEX/Omniflex IV Overhead Tube Crane Components TRANSVERSE CARRIAGE

TRANSVERSE BRIDGE

X-RAY TUBE

TELESCOPING TUBE ARM TUBE MOUNT

CONTROL CONSOLE

COLLIMATOR LONGITUDINAL CEILING RAILS

050845_1_1

1-2

Introduction

EPEX/Omniflex IV System User’s Guide

Figure 1-2. Tower (encloses Bucky counter weight)

EPEX/Omniflex IV Radiographic Table

Operator Control Switches

Patient Support Device

Bucky pivot point

Electro/ mechanical components I/O interface

Horizontal track Tower pivot point

Table Movement Controls Bucky Link Joint

PB20_116.CDR

What Is DirectRay? DirectRay directly captures and converts X-ray energy into digital electrical signals. •

The captured signals (14-bit image data) are immediately transmitted into a DirectRay Controller. The 14-bit linear data is converted into 12-bit log data.

•

An Exam Specific Algorithm (ESA), associated with the user-selected radiographic procedure and position, is used to create a look-up table (LUT) for the image.

•

The LUT is applied to the 12-bit log data to optimize the image data prior to viewing it on the DirectRay Console monitor. If the user accepts the image, the LUT is sent with the image data to the selected output devices.

Indications for Use The EPEX/Omniflex IV system has applications whenever DirectRay radiographic images are created, and transmission of these images and related text are required from DirectRay technology to hardcopy, softcopy, or archive. Follow all safety labels on the equipment.

Introduction

1-3

EPEX/Omniflex IV System User’s Guide

System Functions Table 1-1 indicates where you can find information about specific system functions. Table 1-1. EPEX/Omniflex IV Functions

EPEX/Omniflex IV Functions

For More Information

Operator Input Associate patient data with radiographic images

Chapter 2

Define the study

Chapter 2

Select the output destinations

Chapter 2

Modify output device parameters

DirectRay Console Administrator’s Guide

Save an incomplete procedure

Chapter 2

Close a procedure

Chapter 2

Work with multiple open studies

DirectRay Console User’s Guide

Projection Position the Radiographic Table and Bucky to support a wide variety of radiographic projections

EPEX Radiographic Table User’s Guide

Position the X-ray tube to support a wide variety of radiographic projections

Chapter 2

Image capture and processing

1-4

Adjust technique settings

DirectRay Console User’s Guide,

Capture the required X-ray image

Chapter 2

Preview, accept, or reject the image

Chapter 2

Crop images

DirectRay Console User’s Guide,

Introduction

EPEX/Omniflex IV System User’s Guide

Table 1-1. EPEX/Omniflex IV Functions

EPEX/Omniflex IV Functions

For More Information

Administrative Resend images

Chapter 3

Repreview images

Chapter 3

Protect selected patient/image files from reclamation

Chapter 4

Calibrate the DirectRay Detector

Chapter 5

System administration tasks

DirectRay Console Administrator’s Guide

System Components The EPEX/Omniflex IV is composed of the following components: •

DirectRay Detector

•

X-ray tube and Collimator

•

Radiographic table with articulating arm and Bucky

•

Overhead tube crane

•

DirectRay Console with DirectRay Controller. The following are contained on and within the DirectRay Console cabinet: • CPU (Central Processing Unit) • Monitor • Keyboard • Pointing Device • Bar Code Reader (optional) • WAMI (Wiring Adaptable Machine Interface) • Uninterruptible Power Supply (UPS)

•

Introduction

X-ray Generator

1-5

EPEX/Omniflex IV System User’s Guide

DirectRay Detector/Bucky The Bucky includes: •

The DirectRay Detector

•

A grid with the DirectRay Detector

•

AEC (Automatic Exposure Control)

You can use the positioning controls and rotation system to position the DirectRay Detector for a full range of patient needs.

X-ray Tube and Collimator The EPEX/Omniflex IV system includes: •

Rotating anode X-ray tube

•

Collimator with shutter control

Radiographic Table The Radiographic Table is an X-ray table, articulating arm, and Bucky support subsystem integrated into the Del EPEX/Omniflex IV General Radiography System. The Bucky support is an articulated structure that is attached to the baseplate assembly for longitudinal travel. You can position the Bucky around the table and patient, thus accommodating a variety of radiographic projections. The support tower is fully counter-balanced with the Bucky installed, permitting the Bucky to be positioned with a minimum of effort. The Radiographic Table features include: •

4-way floating table top for positioning ease

•

Capacity of up to 203 kg (450 lb)

•

102 to 188 cm (40 to 72 in.) source-to-image distance (SID)

•

Removeable grid for low dose extremity and pediatric views

•

Head-to-toe Bucky range of motion

•

Full upright and chest capability

X-ray Generator The X-ray Generator has the following features:

1-6

•

Operator control through the DirectRay Console user interface

•

Anatomical pre-programmed exposure factors

Introduction

EPEX/Omniflex IV System User’s Guide

Omniflex IV Overhead Tube Crane The Omniflex IV overhead tube crane is a ceiling-mounted overhead X-ray tube crane and Collimator suspension system. It provides flexibility in X-ray room design since it occupies no floor space and the rail design allows the tube to operate within a large area as defined by the ceiling rails. The telescoping tube arm allows the tube to be lifted up out of the way when not in use.

DirectRay Console The DirectRay Console is the interface between the operator, the other system components, and the Hospital Information System/Radiology Information Systems (HIS/RIS). The DirectRay Console application allows you to perform the following functions: •

Input or retrieve patient and exam data

•

Control the exposure and image capture subsystems

•

Acquire and process digital X-ray image data

•

Output patient and exam data

•

Administrative tasks

The DirectRay Console includes the following hardware components, shown in Figure 1-3:

Introduction

•

Computer with monitor, keyboard, pointing device (mouse or trackball), and modem

•

Uninterruptible power supply (UPS)

•

DirectRay Controller

•

Prep/Exposure switch

•

Bar Code reader, (optional)

•

Wiring Adaptable Machine Interface (WAMI)

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EPEX/Omniflex IV System User’s Guide

Figure 1-3.

DirectRay Console Components

Image Preview Monitor

Bar Code Reader Pointing Device

X-ray Generator Power Switches

Network Connection Keyboard

DirectRay Console Computer Serial Extension Bar 0 1

OFF ON

Modem

AA CD RD SD

Prep/Expose Switch

TR CS ARQ /FAX

POW ER BAS S BBS T VOLU ME

DirectRay Controller

J1

2 J1

1

J1

0

J9

Speakers

J8 J7

J6 J5

J4 J3

J2 J1

WAMI

UPS

Power Supply Transformers

DK10_031.eps

Output Devices You can send images acquired with the EPEX/Omniflex IV system to:

Note: Output devices are not a part of the system. Contact your Del representative for a list of compatible output devices.

•

Image printers (for hardcopy)

•

Workstations (for display)

•

Archive systems (for storage)

The system uses the DICOM (Digital Imaging and Communications in Medicine) protocol to send images and related information to output devices. DICOM is a standard that defines the characteristics of data communication between medical imaging equipment. The DICOM standard was developed by the National Electrical Manufacturer's Association and the American Council of Radiology. For the latest list of approved DICOM connections, see your Del representative. For information about how to operate an output device at your site, refer to the device's documentation.

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Introduction

EPEX/Omniflex IV System User’s Guide

Image Acquisition Patient data available in the facility's Hospital Information System (HIS) or Radiology Information System (RIS) can be imported into the system using the Modality Worklist function. Such data may also be obtained from the system's own temporary records of recent radiographic examinations, or from keyboard entries provided by the operator. Patients whose records are accessible through the facility's HIS/RIS network are typically provided with a bar-coded bracelet. A bar code reader connected to the DirectRay Console is used to scan the paperwork or requisition form and identify the patient. Key patient data from the facility's data base is then entered into the DICOM files for the current radiographic examination. If the facility is not equipped with a HIS/RIS, the system can be prompted to search its own temporary records and copy relevant patient data if it is available. If such data is not available, the operator is prompted to enter patient data manually. It should be noted that the storage capacity of the system is limited and the records of patients who were examined some time ago are not likely to still be in the system.

Introduction

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EPEX/Omniflex IV System User’s Guide

Safety and Compliance Information Safety Precautions •

Do not remove covers from any part of the equipment for any purpose.

•

Do not defeat or bypass built-in equipment safety features.

•

Do not attempt any repairs if the equipment fails to operate correctly. Only qualified Del Field Service Engineers or Del authorized personnel should service the system.

•

Do not attempt to move equipment, or connect or disconnect any communication cables. Call a person qualified and authorized to alter the equipment installation.

•

Observe all warnings and cautions in the procedures.

•

Follow all safety labels on the equipment.

•

Keep fingers, hands, and tools clear of moving parts.

•

Route cables properly to eliminate tripping hazards.

General Use Cautions and Warnings Federal (USA) law restricts this device to sale by or on the order of a physician (or properly licensed practitioner).

CAUTION The EPEX/Omniflex IV system includes no user serviceable parts. For service assistance, contact Del.

WARNING The EPEX/Omniflex IV system produces ionizing radiation.

WARNING The DirectRay Detector may only be operated in an area that is located beyond the 20 Gauss limit.

WARNING

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Introduction