AGFA DR 400 User Manual

DR 400

5520/100

5520/200

User Manual

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2 | DR 400 | Contents

Contents

Legal Notice ..........................................................................	5
Introduction ..........................................................................	6
Introduction to this Manual .......................................	7
Scope of this Manual ......................................	8
Warnings, Cautions, Instructions and Notes ....
9
Disclaimer ...................................................	10
Introduction to DR 400 ............................................	10
Intended Use ...............................................	11
Intended User ..............................................	12
Configuration ..............................................	13
Equipment Classification .............................	16
Options and Accessories ...............................	17
Operation Controls ......................................	18
System Documentation ................................	27
Training .......................................................	28
Product Complaints .....................................	29
Compatibility ...............................................	30
Compliance .................................................	31
Connectivity ................................................	33
Installation ..................................................	34
Radiation Protection ....................................	35
Labels ..........................................................	40
Cleaning and Disinfecting ............................	46
Patient data security ....................................	49
Maintenance ................................................	50
Environmental protection ............................	53
Safety Directions ..........................................	54
Getting started .....................................................................	58
Starting the System ..................................................	59
Basic workflow using the DR Detector ......................	60
Step 1: retrieve the patient info ....................	61
Step 2: select the exposure ...........................	62
Step 3: prepare the exposure ........................	63
Step 4: check the exposure settings ..............	64
Step 5: execute the exposure ........................	65
Step 6: perform a quality control ..................	66
Basic workflow using a CR cassette ..........................	67
Step 1: retrieve the patient info ....................	68
Step 2: select the exposure ...........................	69
Step 3: prepare the exposure ........................	70
Step 4: check the exposure settings ..............	71
Step 5: execute the exposure ........................	72
Step 6: repeat steps 2 to 5 for the next
subexposures ...............................................	73

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DR 400 | Contents | 3
Step 7: digitize the image .............................	74
Step 8: perform a quality control ..................	75
X-Ray System Positioning ........................................	76
RAD Table Exposures ...................................	77
Oblique Exposures .......................................	78
Lateral Exposures ........................................	79
RAD Wall Stand Exposures ..........................	80
Guidelines for Pediatric Applications .......................	81
Stopping the System ................................................	83
Operation ............................................................................	84
Tube head display ....................................................	85
RAD Table and X-Ray Tube Stand ............................	86
Positioning the X-Ray Tube Stand ................	88
Positioning the RAD Table ...........................	91
Positioning the Bucky ..................................	93
RAD Table Accessories .................................	94
RAD Wall Stand .......................................................	96
Positioning the RAD Wall Stand ...................	98
RAD Wall Stand Accessories .......................	101
Bucky ....................................................................	104
Bucky configuration ...................................	106
Rotating the bucky .....................................	109
Loading of the bucky in the RAD Table .......	110
Loading of the bucky in the RAD Wall Stand ....
111
Unloading of the bucky in the RAD Table	... 112
Unloading of the bucky in the RAD Wall Stand .
113
Centering and collimating ..........................	114
Orientation of DX-D 10C, DX-D 10G in the bucky
........................................................................	116
Grids ......................................................................	118
Grid focal distance color indication ............	119
Grid detection ............................................	120
Storage box for DR Detector and grids ...................	121
Automatic Exposure Control (AEC) ........................	122
Manual Collimator .................................................	123
Dose Area Product Meter (DAP) .................	123
Automatic Collimator ............................................	125
Semi-automatic collimation mode .............	127
Manual collimation mode ..........................	128
Dose Area Product Meter (DAP) .................	129
Effect of SID on patient dose ..................................	130
X-Ray Generator Console .......................................	131
Starting and stopping the generator ...........	132
X-ray tube start-up modes ..........................	133
X-ray generator messages and warning signals .
134
Exposure parameters .................................	139
Problem solving .................................................................	142

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4 | DR 400 | Contents

System messages ...................................................	143
Restoring connection between generator and NX after
generator failure ....................................................	145
Automatic collimation always too wide or too narrow ..
146
Empty Bucky Failure, Double Exposure Failure ......	147
NX does not connect to the generator due to ID tablet ..
148
No table movement ................................................	149
DR Detector is Exceeding the Maximum Working
Temperature ..........................................................	150
DR Detector must be Recalibrated ..........................	151
Technical Data ...................................................................	152
DR 400 Technical Data ..........................................	153
Environmental conditions ..........................	154
Generator Technical Data ......................................	155
RAD Table and X-Ray Tube Stand Technical Data	.. 157
Movement ranges ......................................	158
RAD Wall Stand Technical Data .............................	160
X-Ray Tube Technical Data ....................................	162
Bucky Unit Technical Data .....................................	164
Automatic Exposure Control (AEC) Technical Data ....
166
Ralco R221 Collimator Technical Data ...................	167
Ralco R225 ACS Collimator Technical Data ...........	168
Dose Area Product Meter (DAP) Technical Data	.....169
DX-D Fixed DR Detector Technical Data .................	170
Portable DR Detector Technical Data .....................	172
NX Workstation Technical Data .............................	173
DR Generator Sync Box Technical Data ..................	174
Remarks for HF-emission and immunity ............................	175
Remarks for HF-emission and immunity ................	176
Essential performance ...........................................	182
Cables, transducers and accessories .......................	183
For type 5520/200 only .............................	185
Optional ....................................................	185
Stray Radiation ..................................................................	186

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DR 400 | Legal Notice | 5

Legal Notice

0413

Agfa HealthCare NV, Septestraat 27, B-2640 Mortsel - Belgium

For more information on Agfa products and Agfa HealthCare products, please visit www.agfa.com.

Agfa and the Agfa rhombus are trademarks of Agfa-Gevaert N.V., Belgium or its affiliates. DR 400 is a trademark of Agfa HealthCare N.V., Belgium or one of its affiliates. All other trademarks are held by their respective owners and are used in an editorial fashion with no intention of infringement.

Agfa HealthCare N.V. makes no warranties or representation, expressed or implied, with respect to the accuracy, completeness or usefulness of the information contained in this document and specifically disclaims warranties of suitability for any particular purpose. Products and services may not be available for your local area. Please contact your local sales representative for availability information. Agfa HealthCare N.V. diligently strives to provide as accurate information as possible, but shall not be responsible for any typographical error. Agfa HealthCare N.V. shall under no circumstances be liable for any damage arising from the use or inability to use any information, apparatus, method or process disclosed in this document. Agfa HealthCare N.V. reserves the right to make changes to this document without prior notice. The original version of this document is in English.

Copyright 2015 Agfa HealthCare N.V

All rights reserved.

Published by Agfa HealthCare N.V.

B-2640 Mortsel - Belgium.

No part of this document may be reproduced, copied, adapted or transmitted in any form or by any means without the written permission of Agfa HealthCare N.V.

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6 | DR 400 | Introduction

Introduction

Topics:

•Introduction to this Manual

•Introduction to DR 400

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DR 400 | Introduction | 7

Introduction to this Manual

Topics:

•Scope of this Manual

•Warnings, Cautions, Instructions and Notes

•Disclaimer

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8 | DR 400 | Introduction

Scope of this Manual

This User Manual describes the features of the DR 400 System, an integrated X-Ray imaging system. It explains how the different components of the DR 400 System work together.

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DR 400 | Introduction | 9

Warnings, Cautions, Instructions and Notes

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

Warning: Warnings are directions which, if they are not followed, can cause fatal or serious injuries to a user, engineer, patient or any other person or can lead to a mistreatment.

Caution: Cautions are directions which, if they are not followed, can cause damage to the equipment described in this manual or any other equipment or goods and can cause environmental pollution.

Instruction: This sign is typically used in combination with the warning sign when providing a specific instruction. If it is followed exactly, it should avoid the subject of the warning.

Note: Notes provide advice and highlight unusual points. A note is not intended as an instruction.

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10 | DR 400 | Introduction

Disclaimer

Agfa assumes no liability for use of this document if any unauthorized changes to the content or format have been made.

Every care has been taken to ensure the accuracy of the information in this document. However, Agfa assumes no responsibility or liability for errors, inaccuracies or omissions that may appear in this document. To improve reliability, function or design Agfa reserves the right to change the product without further notice. This manual is provided without warranty of any kind, implied or expressed, including, but not limited to, the implied warranties of merchantability and fitness for a particular purpose.

Caution: In the United States, Federal law restricts this device to sale by or on the order of a physician.

Introduction to DR 400

Topics:

•Intended Use

•Intended User

•Configuration

•Equipment Classification

•Options and Accessories

•Operation Controls

•System Documentation

•Training

•Product Complaints

•Compatibility

•Compliance

•Connectivity

•Installation

•Radiation Protection

•Labels

•Cleaning and Disinfecting

•Patient data security

•Maintenance

•Environmental protection

•Safety Directions

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DR 400 | Introduction | 11

Intended Use

•The DR 400 system is a General Radiography X-ray imaging system used in hospitals, clinics and medical practices by physicists, radiographers and radiologists to make, process and view static X-ray radiographic images of the skeleton (including skull, spinal column and extremities), chest, abdomen and other body parts on adult or pediatric patients.

•Applications can be performed with the patient in the sitting, standing or lying position.

•This device is not intended for mammography applications.

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12 | DR 400 | Introduction

Intended User

This manual has been written for trained users of Agfa products and trained diagnostic X–Ray clinical personnel who have received proper training.

Users are those persons who actually handle the equipment and those who have authority over the equipment.

Before attempting to work with this equipment, the user must read, understand, note and strictly observe all warnings, cautions and safety markings on the equipment.

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DR 400 | Introduction | 13

Configuration

DR 400 is a configurable DR (Direct Radiography X-ray system) or CR (Computed Radiography) X-ray system.

The complete DR 400 consists of the following components:

•RAD Table with an integrated DX-D Fixed DR Detector or with a bucky. In the bucky a DR Detector or a CR cassette can be inserted.

•RAD Wall Stand with an integrated DX-D Fixed DR Detector or with a bucky. In the bucky a DR Detector or a CR cassette can be inserted.

•X-ray tube stand mounted on the RAD Table

•X-ray generator integrated in the RAD Table

•X-ray generator console

•X-ray tube with manual or automatic collimator

•NX image processing software on the NX workstation

•DR Generator Sync Box (depending on the configuration)

•Automatic Exposure Control (AEC)

•Dose Area Product Meter (DAP, optional)

Depending on the configuration the following components are also available:

• Portable DR Detector

DR 400 can be used in combination with:

•DX-G

•DX-M

•CR 30-X (5175/2XX)

•CR 30-Xm

•CR 10-X

•CR 12-X

•CR 15-X

DR 400 has three main configurations:

1.DR configuration with X-ray exposure parameter control on the NX workstation.

2.CR configuration with X-ray exposure parameter control on the NX workstation.

3.Mixed DR and CR configuration with X-ray exposure parameter control on the NX workstation.

X-ray parameters are controlled using the Software Console on the NX workstation.

The Software Console is available on the NX workstation, to synchronize the X-ray exposure parameters between the NX application and the generator.

Other configurable features include:

• Tube head display with controls for X-ray exposure parameters

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14 | DR 400 | Introduction

•Position tracking for keeping constand SID on table and wall stand

•Bucky with automatic cassette size sensing (ACSS) and automatic collimator

1		2	3	4		5		6

1.NX workstation

2.X-ray tube stand mounted on RAD Table

3.X-ray tube with collimator and tube head display

4.Portable DR Detector

5.RAD Table with integrated generator

6.RAD Wall Stand

Figure 1: DR 400 configuration for DR

Topics:

•Applied Parts

Applied Parts

Applied Parts refer to parts of the medical electrical equipment that in normal use necessarily comes into physical contact with the patient for the equipment to perform its function. This system includes the following Applied Parts:

Topics:

•RAD Table

•RAD Wall Stand

•DR Detector

RAD Table

•Table top of the RAD Table

•Patient hand grips (optional)

•Lateral cassette holder (optional)

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DR 400 | Introduction | 15

•Mattress (optional)

•Compression belt (optional)

RAD Wall Stand

•Front panel of the RAD Wall Stand

•Overhead arm support (optional)

•Patient hand grips (optional)

DR Detector

• DR Detector

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16 | DR 400 | Introduction

Equipment Classification

Per EN/IEC 60601-1:2005, EN/IEC 60601-2-54:2009, this device is classified as following:

Table 1: Equipment classification

Class I equipment	Equipment in which protection against electric
	shock does not rely on basic insulation only, but
	includes a fixed connection to mains power with
	protective earth conductor.
Type B equipment	A Type B piece of equipment is one that provides a
	particular degree of protection against electric
	shock particularly regarding allowable leakage
	current and reliability of the protective earth
	protection.
Water ingress	IP10
	This device does not have protection against
	ingress of water.
Cleaning	See section on cleaning and disinfecting.
Disinfection	See section on cleaning and disinfecting.
Flammable anesthetics	This device is not suitable for use in the presence of
	a flammable anesthetic mixture with air, or in
	presence of a flammable anesthetic mixture with
	oxygen or nitrous oxide.
Operation	Continuous operation.

Related Links

Cleaning and Disinfecting on page 46

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DR 400 | Introduction | 17

Options and Accessories

The system is delivered with a set of labels. When using multiple DR Detectors, on the labels a nickname is written to identify the DR Detector. An identical label is attached to the bucky of the X-ray system to identify the dedicated workspace of each DR Detector.

For information on options and accessories of the DR Detector, refer to the user manual of the DR Detector.

Related Links

RAD Table Accessories on page 94

RAD Wall Stand Accessories on page 101

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18 | DR 400 | Introduction

Operation Controls

Topics:

•RAD Table

•RAD Wall Stand

•Control Panel of the X-Ray Tube Stand

•NX Application on the NX Workstation

•Software Console

•DR Detector Switch

•X-ray generator mini console

•Manual collimator

•Automatic collimator

•DR Detector

•Emergency stop button

•Emergency shutdown power switch

RAD Table

The RAD Table is used for positioning of the patient lying or sitting over the detector or the cassette in the bucky for exposure.

The RAD Table supports the patient and the detector or the cassette for free exposure.

Figure 2: RAD Table

Related Links

RAD Table and X-Ray Tube Stand

RAD Wall Stand

The RAD Wall Stand is used for positioning of patients standing upright or sitting towards the bucky for exposure.

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DR 400 | Introduction | 19

Figure 3: RAD Wall Stand with vertical bucky

Related Links

RAD Wall Stand on page 96

Control Panel of the X-Ray Tube Stand

Figure 4: Control Panel of the X-Ray Tube Stand with tube head display (controls for X-ray tube position and for X-ray exposure parameters)

Figure 5: Control Panel of the X-Ray Tube Stand with X-ray tube angle display

Related Links

RAD Table and X-Ray Tube Stand on page 86

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DR 400 | Introduction | 21

Figure 8: Software Console

DR Detector Switch

The DR Detector Switch is available in the device status frame of the Software Console.

The DR Detector Switch shows which DR Detector is active and shows its status. The DR Detector Switch can be used to activate another DR Detector. The DR Detector Switch can be switched to CR, depending on the configuration.

Figure 9: DR Detector Switch

DR Detector Status

Battery status icon

Meaning

Full

Medium

Low

Empty

Connection status icon (wifi/ wired)

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22 | DR 400 | Introduction

Meaning			Good	Low		Bad		Wired DR Detector
DR detector									?
status icon
		(blinking)
Meaning	Ready	Initializing		Error		Sleep			One DR detector
		exposure							must be selected

X-ray generator mini console

The X-ray generator mini console is available in the operator room.

1 2 3

7

5

4

6

8

1.Power ON button

2.Power ON indicator

3.Power OFF button

4.Press and hold to prepare for exposure

5.Prepare ready indicator

6.Press and hold to start the exposure

7.Radiation indicator

8.Exposure button

Figure 10: X-ray generator mini console

Exposure button

Preparing for exposure

Press the exposure button down to the first pressure point and hold it for approximately 0.5 s to 2 s.

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DR 400 | Introduction | 23

The X-ray tube is prepared for performing an exposure.

Starting the exposure

Before starting the exposure:

1.Check if the exposure settings displayed on the console are suitable for the exposure.

2.Check the Ready for Exposure status.

Press the exposure button down fully and keep it pressed until the exposure has ended.

The radiation indicator on the control console lights up and a signal sounds to indicate the exposure.

Note: Letting the exposure button go ends the exposure immediately and the exposure can be underexposed.

Manual collimator

The collimator sets the exposure field and displays it by means of a light field.

The collimator provides X-ray filtering using the integrated filters or by inserting a filter in the rails.

A DAP meter (Dose Area Product Meter) can be mounted on the collimator by inserting it in the rails.

Figure 11: Collimator

Related Links

Ralco R221 Collimator Technical Data on page 167

Automatic collimator

The collimator sets the exposure field and displays it by means of a light field.

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24 | DR 400 | Introduction

The collimator provides X-ray filtering using the integrated filters or by inserting a filter in the rails.

An integrated DAP meter (Dose Area Product Meter) in the collimator is available as an option.

Figure 12: Collimator

Related Links

Automatic Collimator on page 125

Automatic Cassette Size Sensing on page 114

Ralco R225 ACS Collimator Technical Data on page 168

DR Detector

When performing an exposure, keep in mind the following detector orientation aids:

1.Tube side

2.Patient orientation marker

For an overview of the operation controls of the DR Detector, refer to the user manual of the DR Detector.

The DR Detector may come in contact with the patient.

Note: DR Detectors that operate wireless contain an RF transmitter. For detailed information, refer to the DR Detector User Manual.

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DR 400 | Introduction | 25

Emergency stop button

Figure 13: Emergency stop button

If a system malfunction causes an emergency situation involving the patient, operating personnel or any system component, activate the emergency stop on the RAD Table. All motor driven movements will be stopped.

Motor driven movements:

•RAD Table

•RAD Wall Stand

•X-ray tube stand

To allow motorized movements again, turn the cap of the emergency switch in clockwise direction (default position).

Warning: The emergency stop button does not switch off the voltage in the X-ray system.

Emergency shutdown power switch

Use the emergency shutdown power switch, if a dangerous situation cannot be eliminated by pressing the emergency stop button.

Warning: Use the emergency shutdown power switch in case of danger to patients, operators, third parties, or one of the units. The entire system will be shut down and the power supply will be disconnected.

The emergency shutdown power switch for the room is typically located on the wall and easy to access, often close to the power off switch of the X-ray system. It is installed and labeled by customer.

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26 | DR 400 | Introduction

Warning: It must be ensured that the emergency switches are always freely accessible.

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DR 400 | Introduction | 27

System Documentation

The DR 400 user documentation consists of

• DR 400 User Documentation CD (digital media)

•NX User Documentation CD (digital media) The DR 400 User Documentation CD contains:

•DR 400 User Manual (this document)

•DX-D Software Console, DR Tube Head Display User Manual, document 0389

•User manuals for the supported DR Detectors

•DX-D DR Detector Calibration Key User manual, document 0134

Other documentation available on the DR 400 User Documentation CD:

•DAP Datasheet

•X-ray Tube Documentation

•Collimator Datasheet

•AEC Datasheet

•X-ray Generator User Manual

•Test Report for IEC60601-1-3

•Test Report for DIN6868-150

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28 | DR 400 | Introduction

Training

The user must have received adequate training on the safe and effective use of the system before attempting to work with it. Training requirements may vary from country to country. The user must make sure that training is received in accordance with local laws or regulations that have the force of law. Your local Agfa or dealer representative can provide further information on training.

The user must note the following information in the system documentation:

•Intended Use.

•Intended User.

•Safety Directions.

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DR 400 | Introduction | 29

Product Complaints

Any health care professional (for example a customer or a user) who has any complaints or has experienced any dissatisfaction with the quality, durability, reliability, safety, effectiveness, or performance of this product must notify Agfa.

If the device malfunctions and may have caused or contributed to a serious injury, Agfa must be notified immediately by telephone, fax or written correspondence to the following address:

Agfa Service Support - local support addresses and phone numbers are listed on www.agfa.com

Agfa - Septestraat 27, 2640 Mortsel, Belgium Agfa - Fax [phone]

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30 | DR 400 | Introduction

Compatibility

The system must only be used in combination with other equipment or components if these are expressly recognized by Agfa as compatible. A list of such equipment and components is available from Agfa service on request.

Changes or additions to the equipment must only be carried out by persons authorized to do so by Agfa. Such changes must comply with best engineering practice and all applicable laws and regulations that have the force of law within the jurisdiction of the hospital.

3231A EN 20150710 1114