DRX-Ascend System Software Guide 3rd Edition July 2012

CARESTREAM DRX-ASCEND System Software User Guide Document No.: AA3471 Copyright Carestream Health, Inc. 2012 All rights reserved. No part of this manual may be reproduced or copied in any form by any means-graphic, electronic, or mechanical, including photocopying, typing, or information retrieval systems-without written permission of Carestream Health. Use of Manual CARESTREAM Systems are designed to meet international safety and performance standards. Personnel operating the unit must have a thorough understanding of the proper operation of the system. This manual has been prepared to aid medical and technical personnel to understand and operate the system. Do not operate the system before reading this manual and gaining a clear understanding of the operation of the system. If any part of this manual is not clear, please contact your Carestream Health representative for clarification.

Complies with FDA Center for Devices and Radiological Health (CDRH)-Title 21 CFR Subchapter J and EC Directive 93/42/EEC for Medical Devices. EU Authorized Representative: Carestream Health France 1, rue Galilée 93192 NOISY-LE-GRAND CEDEX France

Carestream Health, Inc. 150 Verona Street Rochester, NY 14608 CARESTREAM and DRX are trademarks of Carestream Health, Inc. © Carestream Health, Inc. 2012

Table of Contents Description Safety and Regulatory Information... General Safety and Regulatory Information... WARNINGS, CAUTIONS, NOTES... Operator Safety Notice... Regulatory Compliance... Compatibility... Intended Operator... Training... Accompanying Documentation... Applicable Standards... Environmental Protection... Patient Environment... Operator Safety Notice... Abbreviation Definition... General Information... Overview of the DRX-ASCEND System... Key Features of the QG-DIG-DRX Integration System... Intended Use... Main Components of the System... Controls and Indicators... Shared Touchscreen Operating Environment... System Operation... Overview... QG-DIG-DRX Integration Screen... Synchronization Between Operating Environments... Generator Status Indicator Icons... Daily Tube Warm-up Procedure... AEC Functional Check... Preparing To Take Exposures... Workspace Selection... Mode Selection... Taking an Exposure and Image Processing... Heat Unit Computer... Error Messages... Publication History...

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Safety and Regulatory Information

Section 1: Safety and Regulatory Information General Safety and Regulatory Information Carestream Health, Inc. products are designed to meet stringent safety standards. All medical electrical equipment requires proper installation, operation, and maintenance (particularly with regard to safety). It is vital that the user read, understand, note, and where applicable, strictly observe all Warnings, Cautions, Notes, and Safety markings within this document and on the equipment. The user should strictly follow all safety directions in this manual to help ensure the safety of users and patients. Every reasonable precaution has been taken during manufacture to safeguard the health and safety of persons who will operate this equipment. The following precautions must be observed at all times.

WARNINGS, CAUTIONS, NOTES The following samples show how warnings, cautions, and notes appear in this document. The text explains their intended use.

WARNING Indicates injury or death is possible if the instructions are not obeyed. Instructs users to refer to documentation if displayed without warning text.

Caution Indicates that damage to equipment is possible if the instructions are not obeyed.

Note Provides advice and highlights unusual points. A note is not intended as an instruction. The purpose of safety icons, such as those shown below, is to indicate at a glance the type of caution, warning, or danger.

WARNING Ionizing radiation: indicates the possibility of increased levels of radiation.

WARNING Warning, hot surface.

WARNING Dangerous voltage; indicates the presence of high voltage.

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Safety and Regulatory Information

WARNING X-rays are hazardous to both patients and operators unless established safe exposure factors and operating instructions are observed. Only qualified and authorized personnel shall operate this system. In this context, qualified means those legally permitted to operate this equipment in the jurisdiction in which the equipment is being used, and authorized means those authorized by the authority controlling the use of the equipment. Full use must be made of all radiation protection features, devices, systems, procedures and accessories. It is important that everyone having anything to do with x-radiation be properly trained and fully acquainted with the recommendations of the National Council on Radiation Protection and Measurements as published in NCRP Reports available from NCRP Publications, 7910 Woodmont Avenue, Suite 800, Bethesda, Maryland 20814-3095 (www.ncrp.com), and of the International Commission on Radiological Protection (www.icrp.org), and take adequate steps to protect against injury.

WARNING Carestream Health, Inc. disclaims all responsibility from any injury resulting from improper application of this equipment. This equipment is sold to be used exclusively under the prescribed direction of a person who is licensed by law to operate equipment of this nature. This equipment must be used in accordance with all safety procedures described in this manual and must not be used for purposes other than those described herein. Carestream Health cannot assume responsibility for any malfunctioning of this equipment resulting from improper operation, maintenance, or repair, or from damage or modification of its components. Failure to observe these warnings may cause serious injuries.

WARNING X-ray equipment may cause injury if used improperly. The instructions contained in this manual must be read and followed when operating this unit. Personal radiation monitoring and protective devices are available. You are urged to use them to protect against unnecessary X-ray exposure.

Operator Safety Notice Regulations require that the Operator of this equipment remain within visual range of all exposure indicator icons displayed on the Operator’s screen during all phases of each exposure cycle. Furthermore, the Operator must remain within the audible range of the audible alarm generated during exposure cycles. Accordingly, the Power/Expose Control Box must be securely mounted as to comply with the foregoing.

Regulatory Compliance This medical device has been designed, manufactured, and calibrated to comply with governing U.S. Federal Regulations 21 CFR, Subchapter J and the performance standards attendant thereto. Upon installation, all certified products require the filing of Form FD-2579 "Report of Assembly of a Diagnostic X-ray System" by the assembler (the installer) with the appropriate agencies. The "Installation Quality Assurance Checklist" must also be completed and properly distributed upon installation. Those responsible for the planning of X-ray equipment installations must be thoroughly familiar and comply completely with NCRP Report No. 49, "Structural Shielding Design and Evaluation for Medical Use of X-Rays and Gamma Rays of Energies up to 10 MeV," as revised or replaced in the future. Those authorized to operate, test, participate in, or supervise the operation of the equipment must be thoroughly familiar and comply completely with the currently established safe exposure factors and procedures described in publications such as Subchapter J of Title 21 of the Code of Federal Regulations, "Diagnostic X-Ray Systems and Their Major Components," and NCRP Report No. 102, “Medical X-Ray, Electron Beam and Gamma Ray Protection for Energies Up to 50 MeV-Equipment Design and Use” as revised or replaced in the future. Scheduled maintenance is essential to the assurance of continued integrity of this equipment with respect to regulatory compliance. The continuance of certified performance to the regulatory standard is incumbent upon the user's diligent conformance to recommended maintenance instructions.

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Safety and Regulatory Information

Compatibility The equipment described in this manual must only be used in combination with other equipment or components if these are expressly recognized by Carestream Health, Inc. as compatible.

Intended Operator This device is intended to be installed, used and operated only in accordance with the safety procedures given within this manual for the purpose for which it was designed. Before attempting to work with this equipment, read, understand, note and strictly observe all warnings, cautions and safety markings on the equipment. Users include those persons who actually handle the equipment and those who have authority over the equipment.

Training Users of this device shall have received adequate training on its safe and effective use before attempting to work with the equipment. Training requirements may vary from country to country. The User shall make sure that training is received in accordance with local laws or regulations that have the force of law.

Accompanying Documentation The documentation consists of a User Manual (this document) and related documentation: • QG-DIG-DRX Service Manual P/N DC30-122: Contains technical and service documentation for this product, including installation and configuration instructions to be performed by qualified persons. • ODYSSEY, Q-VISION HF Series X-ray Generator Service Manual P/N DC30-011: Contains technical and service documentation for the HF Series X-ray Generator, including installation and configuration instructions • Refer to the DRX-1 Digital Radiography System documentation set for instructions regarding the use of all DRX1 system components and software The documentation shall be kept with the system for easy reference.

Applicable Standards This equipment complies with the following regulatory standards: • FDA Center for Devices and Radiological Health (CDRH)-Title 21 CFR Subchapter J • UL 60950/IEC 60950 Information Technology Equipment (ITE)

Environmental Protection This equipment contains certain materials and chemical compounds incidental to the manufacture of electrical and electronic equipment, and improper "end-oflife" disposal of such equipment can result in environmental contamination. Therefore, this equipment should not be disposed of as ordinary household waste, but should instead be delivered to a designated electrical and electronic waste disposal or recycling center. For further information on disposing of electrical and electronic waste, contact the cognizant authority within the jurisdiction.

Patient Environment The following components of the DRX-Ascend System are NOT permitted inside the patient environment: • X-ray generator (including operator control panel-All Models) • DRX-1 Workstation Computer When the generator is configured with the DRX-Ascend Operator Console, the associated workstation computer functions as the generator Operator Control Panel (OCP). If the workstation is qualified to standard UL 60950/ IEC 60950 for Information Technology Equipment, the workstation must be placed outside the radius of the patient environment, as shown below. Consult with the user of the system when determining the location for the workstation

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Safety and Regulatory Information

computer. Consider all areas the patient may access, including the room entrance and/or exit, when establishing the patient environment.

2.5 m (8.2 ft)

1.5 m (4.9 ft)

(4.9 ft)

1.5 m (4.9 ft)

Operator Safety Notice Regulations require that the Operator of this equipment remain within visual range of all exposure indicator icons displayed on the Operator’s screen during all phases of each exposure cycle. Furthermore, the Operator must remain within the audible range of the audible alarm generated during exposure cycles. Accordingly, the Power/Expose Control Box must be securely mounted as to comply with the foregoing. The following symbols and acronyms may be used for marking on this equipment or equipment documentation.

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Earth

Dangerous Voltage

Protective Earth (ground)

Attention (consult operating instructions)

Type B Equipment

Enable Longitudinal Tube Motion

Enable Tube Angulation Motion

Enable Vertical Tube Motion

Enable Rotation of Vertical Column Motion

Enable Transverse Tube Motion

Enable Auto-Stop Function

Non-ionizing Radiation

Enable Tube Motion in all Directions

Connection Point for the Neutral Conductor on Permanently Installed Equipment

Enable Tabletop Float (releases transverse and longitudinal locks)

Enable Tabletop Up Motion

Alternating Current

Enable Tabletop Down Motion

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Safety and Regulatory Information

Abbreviation Definition The following abbreviations and acronyms may be found in this document. Their definition is explained below: Abbreviation

Definition

AEC

Automatic Exposure Control

CAT 5

Category 5 Ethernet Cable

CDRH

Center for Devices for Radiological Health

CsI

Cesium Iodide

DAP

Dose Area Product

DR

Digital Receptor

GOS

Gadolinium Oxysulphide

kVp

kilovolt peak

kW

kilowatt (1000 watts)

Ma

milliampere

mAs

milliampere Seconds

MeV

mega-electron volt

mR

millioentgen

NCRP

National Council on Radiation Protection

OCP

Operator Control Panel

PACS

Picture Archiving Communication System

VGA

Video Graphics Array

ADC

Analog-to-digital converter

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General Information

Section 2: General Information Overview of the DRX-Ascend System This manual provides information for the operation of the DRX-Ascend System, which is a communications interface between the CARESTREAM DRX-1 Digital Radiographic Imaging Workstation and Quantum Medical Imaging HF Series X-ray Generator.

Note The user should read this manual in its entirety prior to using this equipment. It should be kept in a location near the equipment and be readily accessible to those who operate it. When the QG-DIG-DRX Integration System is installed, all user interaction with the HF Series X-ray Generator is accomplished via the Workstation’s touchscreen, thereby eliminating the need for a separate Operator Control Panel for the generator. In addition, Quantum’s optional TechVision Control Panel can be installed and synchronized with the DRX-1 Workstation to optimize operator efficiency.

Note TechVision is a functional operator interface control panel providing access to generator controls and visual presentation of the exposures taken in the current study. TechVision is designed for installation in the patient area, and has full programming/editing capability, but it cannot activate an exposure. Once the patient is registered in the DRX environment and the appropriate body part examination procedure is selected, the generator control parameters are uploaded prior to performing the exposure. DRX-Ascend System technology is available for DRX-1 Series digital detectors, in applications where a DRX-Ascend System, including an HF Series X-ray Generator, is installed. The QG-DIG-DRX System software resides on the DRX-1 Workstation computer hard disk, and is automatically loaded whenever the workstation computer is powered up. Combining the image acquisition capacity of the DRX-1 digital detectors with QG-DIG-DRX System software controlling an HF Series Generator, worklists compiled from stored patient profiles, or those manually entered, are displayed for immediate disposition in the DRX operating environment. Operation of the DRX-Ascend System software is accomplished through a touch-sensitive operator control panel screen integrated with the DRX-1 Workstation screen. Once the DRX Software is installed and a Service Technician has completed the system and generator setup, it is not necessary for the operator to access and adjust the Service Options.

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General Information

The image below shows the seamless integration of the HF Series Generator Control Panel with the DRX-1 Workstudy environment, prior to selecting a patient profile.

Note The Receptor chosen on the Workstudy screen is synchronized with the Receptor choices by a configuration process performed by a Service Technician. Operator Screen for the CARESTREAM DRX-1 DR System Integrated with QG-DIG-DRX System

DRX-1 User Interface Screen

Generator Control Panel

Electrical power to the generator is controlled via a Power/Expose Control Box, which houses an ON/STBY rocker switch and indicator LED. The Power/Expose Control Box also serves as an interface for the two-stage Expose switch, which enables the operator to trigger the exposure (“one-button” exposure, or “prep” exposure). The Expose Switch is hard-wired to the Power/Expose Control Box, with an expansion cable which allows the operator to move about the area.

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General Information

Key Features of the QG-DIG-DRX Integration System It is imperative that all safety procedures described in this manual be strictly adhered to in order to ensure the safety of both patient and user. The key features of the DRX-Ascend System are as follows: • Elimination of separate control units for each operating environment. • Transparent upload and translation of selected Patient Procedure List and Patient Data from the DRX environment to the generator. • Integrated touchscreen, presenting DRX Radiographic Imaging screens and menus, and adjacent to that is Quantum’s Generator Control Panel, with several adjustments. – exposure settings – receptor selection – manual or AEC mode of operation – Generator status – Tube Heat and Post Time/mAs callouts • Power/Expose box with generator ON/STBY switch, and two-stage Expose Switch, including expansion cable. • Three Standard Receptor groups (Wall, Table, and None), with the capacity to define multiple “named” receptors and calibrations for Wall and Table (e.g., Wireless1, Wireless2, etc). • The "None" Workspace enables exposures without a digital receptor present, such as when seasoning the X-ray tube, or for calibrating the generator (service function only). • Universal AEC option for expanded AEC capability • Multi-language display capability

Intended Use The DRX-Ascend System provides diagnostic quality images to aid the physician with diagnosis. It can be used to perform radiographic exposures of the skeleton (including skull, spinal column, and extremities), chest, abdomen, and other body parts. This System is not indicated for use in mammography.

Main Components of the System Successful integration of the QG-DIG-DRX System requires the following hardware components, provided with the DRX and Quantum Medical Imaging Radiographic Systems. 1. DRX-1 Workstation touchscreen display monitor-Provides visual display of various data modules, and supports the Quantum Generator Control Panel (a touchscreen occupying the area to the right of the DRX operating screen). 2. Workstation computer-Provides operational capability for DRX-1 Workstation, and supports Ethernet communications between the workstation (running Quantum’s QG-DIG-DRX Integration Software) and the generator. 3. Power/Expose control box-Provides control of the generator’s main power, and interfaces the two-stage Expose Switch to the generator. 4. Ethernet switch to interface the generator to the workstation and peripherals.

Note The Power/Expose control box must be securely mounted in a location where the operator can hear the audible alarm output during exposure cycles, and where the operator can see the exposure icons displayed on the workstation screen.

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General Information

Controls and Indicators QG-DIG-DRX Integration Software centralizes and significantly automates operator activities related to preparing for, and executing X-ray examinations with Quantum Medical Imaging radiographic equipment, using input data from the DRX-1 System. Management of the process, after the requirements of the DRX-1 System are met, is accomplished with the following hardware and software control and indicator features: • Generator power ON/STANDBY-Rocker switch housed in the Power/Expose Control Box. An LED indicator illuminates when power is ON. • Expose Switch-Actuates generator circuitry for X-ray exposure. Hand-held switch body with expansion cable. • Generator ON/OFF switch-Electrical breaker style switch, accessed from the side of the generator enclosure (master control for power to the generator). • Touchscreen controls-Generator Control Panel shares the monitor screen with the DRX-1 worklist screen, and displays current generator exposure settings. • Generator Control Panel-Displays the control and indicators shown in the table below. Safety Notice-Exposure Indicators and Audible Alarm Requirements

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General Information

Shared Touchscreen Operating Environment As shown below, the image area of the monitor is shared between the DRX-1 Worksheet screen and the generator control panel, providing access to generator settings at all times. Typically, the generator control panel is synchronized to the DRX-1 Worksheet screen, to the extent that the current patient’s examination profile (once a patient is selected), and a specific examination is chosen, the generator settings are automatically input and displayed on the generator control panel. The operator can choose to alter the programmed settings by simply making the desired changes on the generator control panel before taking the exposure. The image below shows only the portion of the screen that falls into the generator control panel operating environment. Workstation Screen-Shows the DRX-1 and Generator Control Screens

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Generator Control Panel Environment

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9 Generator Control Panel-Controls and Indicator Descriptions Item

Function

Type

Description

1

Generator Status Icons

Indicator/Control

Four icons indicating nine separate states of the generator (see “Generator Status Indicator Icons” on Page 16 for definitions). The Error icon (left) is interactive. Touch the icon and the type of error is described in a dialog box superimposed over the DRX-1 portion of the touchscreen.

2

Post Time/ Post mAs/ Post DAP

Indicators

Displays the Time and mAs values produced in the last exposure. This field also displays DAP, which enables effective tracking of total energy given to the patient.

3

kVp increment/ decrement

Control-Push button

Adjusts the tube voltage (kVp) value from minimum of 40 kVp to maximum of 125 kVp, in 1 kVp increments (150 kVp maximum available in systems equipped with 150 kVp option).

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General Information

Item

Function

Type

Description

4

mA increment/ decrement

Control-Push Button

Sets the tube current (mA) value; mA stations that are available for selection are model dependent. Focal Spot defaults (Small and Large) are shown next to the value displayed. Defaults can be edited in the DRX-1 environment with a CHANGE key.

5

Time increment/ decrement

Control-Push Button

Adjusts the exposure time value. Note that Time can not be set when in AEC mode.

6

mAs increment/ decrement

Control-Push Button

Adjusts the exposure current-time (mAs) value.

7

AEC mode button

Indicator/Control

Selects AEC or Manual mode of operation. AEC mode is active when the button is yellow. Manual mode is active when the AEC button is gray. Note: mAs/time values do not display when AEC mode is enabled.

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Small, medium and large patient selection

Control/Indicator-Push button

Each button is pre-programmed with technique values (see items 3, 4, 5, and 6 above) appropriate for small, medium, and large patients. Allows the operator to quickly acquire the proper technique values.

9

Selection of Workspace (Receptor Location)

Indicator/Control

Settings for the specific (named) receptors assigned under that Workstation button. Additional Receptor names can be added by a Service Technician. Touch the push button on the generator control panel that corresponds to the desired Workspace. • “Wall” selects the wall receptor • “Table” selects a table receptor (loaded in the table drawer) • “Table Top” selects a table receptor (placed on top of the table) “None” selects a mode where the System will expose on command (without regard to feedback from a receptor) Selection of a Workspace button causes the other Workspace buttons to disappear and the QG-DIGDRX software to call calibration.

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10

Tube heat

Indicator

Displays X-ray Tube heat range as percentage of maximum allowable (calculated value depending on Tube model).

11

Selects top left AEC Control/Indicator-Push Field Detector button location

Turns on/off top left AEC Field Detector for AEC exposures (yellow = active).

12

Selects middle AEC Field Detector location

Control/Indicator-Push button

Turns on/off middle AEC Field Detector for AEC exposures (yellow = active).

13

Adjust density

Control/Indicator-Push button

Up and down, in 15 % increments, between +75 % and –75 %. Zero (0) indicates “Normal” density (i.e., no density compensation).

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Selects top right AEC Field Detector location

Control/Indicator-Push button

Turns on/off top right AEC Field Detector for AEC exposures (yellow = active).

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Item

Function

15

Collimator Auto Enable

Control/Indicator-Push button

Enables automatic collimator field sizing based on pre-programmed x, y, and SID settings (yellow = active).

Top left DRX-1 Detector corner of the DRX-1 Panel

Control/Indicator-Push button

Detector enabled when displaying a broad yellow border.

Top left Generator Only corner of the DRX-1 Panel

Control/Indicator-Push button

Generator only enabled when displaying a broad yellow border. Enable when using a non-wireless detector (i.e., CR Cassette), seasoning the X-ray tube, or when performing system physics/QA testing.

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Type

Description

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System Operation

Section 3: System Operation Overview This chapter provides the information necessary to operate DRX-Ascend System Software to obtain images with Quantum Medical Imaging equipment and DRX-1 Digital Radiography Systems. The following operating procedures are outlined and described in detail: • Distinctions between the DRX-1 operating environment and the Quantum QG-DIG-DRX operating environment as encountered on the workstation touchscreen • QG-DIG-DRX Integration System Software control of the generator when synchronized with the DRX-1 Workstation • Operating instructions

WARNING This equipment must be operated with reasonable care. The manufacturer’s equipment recommendations described in this manual must be observed.

QG-DIG-DRX Integration Screen QG-DIG-DRX Software initializes automatically when the DRX-1 Workstation is powered up. The workstation touchscreen presents a single (visually integrated) screen which includes the DRX-1 and Quantum operating environments. The screen for both operating environments is touch-sensitive. The operator can utilize the preprogrammed examination profiles and access the generator controls at any time via the Generator Control Panel, which resides on the right side of the screen. This eliminates the need for a separate Generator Operator Control Panel, and manual generator setting input for examinations associated with a predetermined patient profile. Because the Integration Software operates in sync with the DRX-1 Digital Radiographic System, the operator is provided with not only the convenience of handling all preparatory activities, such as those designed into the DRX-1 system regarding patient information and examination profiles, but also the convenience of adjusting the generator power settings while operating from the workstation area.

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System Operation

Synchronization Between Operating Environments The following figure illustrates how the operating environments are functionally divided. The software running the Generator Control Panel communicates with the DRX-1 Radiographic System, and automatically receives data related to generator settings from pre-programmed patient profiles or manually entered patient data. Generator Control Panel and DRX-1 Operating Environments (Graphically Divided)

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System Operation

Generator Status Indicator Icons The Generator Control Panel indicates the current status of the generator at all times. The following table shows Generator Status Messages which could be displayed under different circumstances during the operation of the DRX-Ascend System. It is recommended that the operator become familiar with each message and its significance to successfully operating the X-ray Generator. The following messages appear to the left of the radiation symbol. Generator Status List Message

Description

DISCONNECTED

Indicates that the Workstation Computer is not communicating with the Generator.

READY

Indicates that the Generator is communicating with the Workstation Computer and is ready for an exposure.

PREPPING

In the process of readying the Generator to begin an exposure. The Prepping icon is revealed during the cycle. A transition from the radiation icon (far left) to the Prepping icon (near left) occurs.

PREPPED

The Generator is ready to accept an expose command.

EXPOSE

The Generator is emitting radiation.

CHARGING

Indicates that the Generator is incapable of making an exposure, and the batteries are charging (Stored Energy Generators only).

FILE ACCESS

Indicates that the Generator is in the process of acquiring operational data from an independent file or a peripheral.

RECOVERY

Indicates that the Generator is connected, but not ready. Can also indicate that data is being acquired, or an equipment process cycle is taking place.

OFF

Indicates that power to the Generator is in STANDBY. This is displayed when the Generator enters its automatic energy conservation mode. It will also be displayed if a power failure occurs, or if the Generator’s Power/Expose Control Box is set to STANDBY.

SLEEP

Indicates that the Generator has reverted to Automatic Power Standby Mode due to inactivity.

ERROR

There is a Generator problem that is causing the need for attention. Touch the error icon to display details about the error.

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