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AGFA XD 14 - User Manual

AGFA XD 14
137 pages
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XD 14, XD14
FXRD-3643VAW
FXRD-3643VAW PLUS
User Manual
0430A EN 20210426 1355

Table of Contents

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Summary

Legal Notice

Introduction to this Manual

Scope

Details the manual's content for safe and effective operation of DR detectors and peripherals.

Safety Notices Explained

Explains the meaning of danger, warning, caution, prohibition, and note symbols used in the document.

Disclaimer

Agfa disclaims liability for unauthorized changes and warranties for accuracy and fitness of information.

Introduction to the DR Detector

Intended Use

Describes the DR detectors as digital X-ray imaging solutions for general-purpose diagnostic procedures.

Indications for Use of the DR Retrofit Solution

Specifies use in general projection radiographic applications for diagnostic quality images of human anatomy.

Intended User

Manual is for trained users; users must read and understand warnings and safety markings.

Configuration

Explains how DR detectors integrate with X-ray systems and communicate with workstations.

Equipment Classification

Details the classification of the DR Detector per EN/IEC60601-1 and lists non-medical equipment.

Options and Accessories

Lists available options like cradle, battery, power adapter, and accessories like anti-scatter grids.

Operation Controls

Lists the components related to operation, such as detector, cradle, chargers, and control units.

XD 14, XD⁺14 Detector Controls

DR Detector Cradle

DR Detector Dual Battery Charger

System Control Unit

System Control Unit Lite

DR Detector Cable

DR Detector Switch

System Documentation

Related Documentation

Lists related documents like MUSICA Acquisition Workstation manuals and DR detector calibration manuals.

Training Requirements

Product Complaints

Compatibility

Compliance

General Compliance

Details design compliance with MEDDEV Guidelines and ISO standards.

Safety Standards

Lists safety standards like IEC 60601-1, AAMI ES 60601-1, and CSA C 22.2 No.60601-1.

Electromagnetic Compatibility and Radio Frequency

References IEC 60601-1-2 for EMC and declares conformity with FCC/ETSI standards for RF.

RF Regulations and SAR

Connectivity

Wireless Communication

Explains wireless communication between DR detector and MUSICA Acquisition Workstation via access point.

Wired Communication

Discusses using accessories and cables and compliance with IEC 60601-1 system requirements.

Installation and Configuration

Environment of Use

Specifies ideal environments for use and lists locations to avoid for safe operation.

Handling System Messages

Understanding Device Labels

DR Detector Labeling

DR Detector Battery Labeling

DR Detector Cradle Labeling

DR Detector Dual Battery Charger Labeling

System Control Unit Labeling

Mini System Control Unit Labeling

System Control Unit Lite Labeling

Consulting the About Box

Cleaning and Disinfecting

Cleaning Procedures

Provides instructions for cleaning the exterior of the equipment safely, including warnings about liquids.

Use of Protective Plastic Bag

Recommends using a protective plastic bag when the detector may contact liquids or contaminants.

Disinfection Guidelines

Instructs to use only Agfa-approved disinfectants and methods for device disinfection.

Disinfection Safety Directions

Outlines safety precautions to be followed during cleaning and disinfection procedures.

Maintenance Procedures

Daily and Half-Yearly Inspections

Details daily checks and indicates when half-yearly calibration is due via a system message.

Regular Inspection and Maintenance

Recommends annual inspection, cleaning, adjustments, or consumables replacement.

Replacement Parts Support

States parts will be stocked for seven years after discontinuance for repair purposes.

Product Repair

Specifies that the product can only be repaired in the factory.

Patient Data Security

Operating Environment Requirements

Details ISP requirements for security and privacy, including firewalls, network intrusion systems, and access controls.

Environmental Protection

Safety Directions

General Safety and Electrical Precautions

Covers installation by certified engineers, avoiding modifications, and warnings about fire/electric shock.

Handling, Usage, and Environmental Safety

Advises on handling, avoiding damage, patient monitoring, temperature, and environmental conditions.

Power Supply Safety

Provides warnings regarding power supply usage, connections, and handling of cords.

System Control Unit Safety

Warns against blocking ventilation, ensuring continuous power, and proper grounding.

DR Detector Battery Safety

Details safe charging, replacement, and handling of the DR detector battery pack, including disposal.

Getting Started

Starting the DR Detector

Step-by-step guide to turn on the DR detector and check its status.

Basic Workflow DR Detector

Outlines the steps for acquiring images using the DR detector, from patient info to quality control.

Offline Image Acquisition Workflow

Describes how to acquire images without a network connection and transfer them later.

Pediatric Application Guidelines

Provides recommendations for reducing dose and ensuring image quality in pediatric imaging.

Stopping the DR Detector

Instructions on how to properly turn off the DR detector and prepare it for storage.

Automatic Exposure Detection

Explains how the DR detector automatically performs image acquisition upon X-ray exposure.

Attaching Handle Unit with Grid

Step-by-step instructions for safely attaching the handle unit with a grid to the DR detector.

Attaching Handle Unit without Grid

Step-by-step instructions for safely attaching the handle unit without a grid to the DR detector.

Advanced Operating Procedures

Viewing Detector Status

Explains how to view the DR detector's status via the power button and status display.

Battery Status

Details the meaning of battery status icons, indicating presence, charging, or charge level.

Connection Status

Illustrates connection status indicators for access point mode, client mode, and wired connections.

Charging a Battery

Outlines four methods for charging the DR detector battery using available accessories.

Replacing the Battery

Provides step-by-step instructions for replacing the DR detector battery using a screwdriver.

Managing Network Connections in Client Mode Configuration

Explains how to manage network connections when the DR detector is configured for client mode.

Managing Network Connections in Access Point Mode Configuration

Details managing network connections when the DR detector is configured for access point mode.

Problem Solving and Troubleshooting

Artifact in DR Detector Images

Addresses artifacts in images, their cause (calibration changes), and solution (re-calibration).

DR Detector Not Ready for Exposure

Troubleshoots why the DR detector status icon is not green, covering connection and mode issues.

DR Detector Not Active (Access Point Mode)

Solves issues where the DR detector is connected but not active, often due to another workstation connection.

Images Not Sent to Printer or PACS Archive

Diagnoses why images are not sent, typically due to the workstation not being connected to the hospital network.

Identifying Problems

Provides a table of common symptoms, their causes, and remedies for detector and control unit issues.

Technical Data

XD 14, XD⁺14 Technical Data

Provides specifications for the DR detectors, including electrical, network, and environmental conditions.

DR Detector Battery Technical Data

Details the technical specifications of the rechargeable lithium-ion polymer battery pack.

DR Detector Cradle Technical Data

Provides technical specifications for the lithium-ion battery pack charger (cradle).

DR Detector Dual Battery Charger Technical Data

Details the technical specifications of the DR detector dual battery charger.

System Control Unit Technical Data

Lists technical specifications for the System Control Unit, including power, wireless, and dimensions.

Mini System Control Unit Technical Data

Provides technical specifications for the Mini System Control Unit, including power and wireless connection.

System Control Unit Lite Technical Data

Details technical specifications for the System Control Unit Lite, including power input.

HF Emission and Immunity Remarks

EMC Statements

States device compliance with EMI/EMC but warns of potential interference in noisy environments.

Electromagnetic Emissions

Details the device's RF emissions compliance with CISPR 11 and IEC standards for hospital environments.

Electromagnetic Immunity

Outlines the device's immunity to electromagnetic disturbances based on IEC 60601 test levels and environmental considerations.

For U.S.A. (FCC Compliance)

Details FCC compliance for the device, including conditions for operation and potential interference.

AGFA XD 14 Specifications

General IconGeneral
BrandAGFA
ModelXD 14
CategorySecurity Sensors
LanguageEnglish

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