DR - 100e User Mnaual

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DR 100e (Digital Radiography)

6012/001
6012/002
6012/003
6012/004

User Manual

0365B EN 20181015 0853


ii | DR 100e (Digital Radiography) | Contents

Contents
Legal Notice .......................................................................... 5
Getting started .......................................................................6
Introduction to this Manual ................................................... 7
Scope of this Manual ..................................................8
About the safety notices in this document .................. 9
System Documentation ............................................ 10
Disclaimer ................................................................11
Introduction ........................................................................ 12
Intended Use ........................................................... 13
Intended User .......................................................... 14
Configuration .......................................................... 15
Operation Controls .................................................. 17
NX Workstation (all-in-one PC) ....................20
NX Application on the NX Workstation .........21
DR Detector Switch ......................................22
Portable DR Detector ................................... 23
Circuit breaker .............................................24
X-ray generator control panel .......................25
Manual Collimator .......................................26
Exposure button ...........................................27
Infrared remote control ................................28
Connectors for the hospital network and for
registering a DR Detector ............................ 29
Led beacon light .......................................... 30
Messages ................................................................. 31
Sound signals .............................................. 32
Status messages ........................................... 32
Warning messages ....................................... 33
Error messages ............................................ 35
Labels ...................................................................... 37
General ........................................................38
Type label .................................................... 41
Labeling of the collimator ............................ 42
Installation .............................................................. 43
Labeling the DR Detectors ............................44
Equipotential earth connection .................... 45
Electrostatic discharge ................................. 46
Radiation Protection ................................................ 47
Monitoring of Personnel ...............................47
Cleaning and Disinfecting ........................................ 48
Cleaning ...................................................... 49
Disinfecting ................................................. 51
Disinfecting safety directions ....................... 52
Approved disinfectants ................................ 53
Patient data security ................................................ 54

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DR 100e (Digital Radiography) | Contents | iii

Maintenance ............................................................55
Preventive maintenance schedule ................ 55
Training ...............................................................................57
Safety Directions ..................................................................58
Basic Workflow ....................................................................62
Starting the NX workstation and the DR Detector .....63
Retrieving the patient info ...................................... 64
Moving the unit ....................................................... 65
Starting the device ...................................................68
Positioning .............................................................. 69
Selecting the exposure ............................................. 71
Preparing the exposure ............................................ 72
Checking the exposure settings ................................ 73
On the NX application .................................. 74
On a DR Detector that has a status indicator ....
74
On the X-ray generator control panel ............74
On the control panel .................................... 74
Executing the exposure ............................................75
Using the wired exposure button ..................77
Using the remote control exposure button ....78
Performing a quality control .................................... 79
Stopping the device ................................................. 80
Using the NX workstation with the X-ray system switched
off ............................................................................81
Stopping the NX workstation and the DR Detector ... 82
Using the ‘virtual keyboard’ ..................................... 83
Restriction on the use of virtual keyboard software
..........................................................................84
Advanced Operation ............................................................ 85
Using a moving grid .................................................86
Using a DAP meter ................................................... 87
DAP value on the NX workstation .................87
Hanging a leaded apron ...........................................88
Making an exposure using a cassette ........................ 89
Setting the exposure parameters on the X-ray
generator control panel ................................89
Modifying the exposure parameters of an anatomic
program .................................................................. 92
Product Information ............................................................ 94
Options and Accessories ...........................................95
Compatibility ...........................................................95
Compliance ............................................................. 95
General ........................................................96
Safety .......................................................... 96
Electromagnetic Compatibility .....................96
Laser Safety ................................................. 96
Connectivity ............................................................ 97
Connecting DR 100e to a wired network ...... 97
Equipment Classification ......................................... 98

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iv | DR 100e (Digital Radiography) | Contents

Product Complaints ................................................. 99


Environmental protection ...................................... 100
Technical Data ....................................................... 101
DR 100e ..................................................... 102
Anatomic program exposure parameters .... 108
DAP meter ..................................................111
Collimator ..................................................112
X-ray generator and X-ray tube assembly .... 113
Remarks for HF-emission and immunity ................ 117
Enclosure Port Immunity to RF wireless
communication equipment ........................ 122
Precautions on EMC ...................................123
Cables, transducers and accessories ........... 124

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DR 100e (Digital Radiography) | Legal Notice | 5

Legal Notice

0413

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


For more information on Agfa products, please visit www.agfa.com.
Agfa and the Agfa rhombus are trademarks of Agfa-Gevaert N.V., Belgium or
its affiliates. DR 100e and NX are trademarks of Agfa NV, 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 NV 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 NV diligently strives to provide as accurate information as
possible, but shall not be responsible for any typographical error. Agfa NV
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 NV reserves the right to make changes to this document
without prior notice. The original version of this document is in English.

Copyright 2018 Agfa NV

All rights reserved.

Published by Agfa NV

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 NV

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6 | DR 100e (Digital Radiography) | Getting started

Getting started
Related Links
Intended Use on page 13
Operation Controls on page 17
Safety Directions on page 58
Basic Workflow on page 62

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DR 100e (Digital Radiography) | Introduction to this Manual | 7

Introduction to this Manual


Topics:

• Scope of this Manual


• About the safety notices in this document
• System Documentation
• Disclaimer

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8 | DR 100e (Digital Radiography) | Introduction to this Manual

Scope of this Manual


This manual contains information for safe and effective operation of the DR
100e mobile X-ray system, further referred to as the device.

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DR 100e (Digital Radiography) | Introduction to this Manual | 9

About the safety notices in this document


The following samples show how warnings, cautions, instructions and notes
appear in this document. The text explains their intended use.
DANGER:
A danger safety notice indicates a hazardous situation of direct,
immediate danger for a potential serious injury to a user,
engineer, patient or any other person.

WARNING:
A warning safety notice indicates a hazardous situation which
can lead to a potential serious injury to a user, engineer, patient
or any other person.

CAUTION:
A caution safety notice indicates a hazardous situation which
can lead to a potential minor injury to a user, engineer, patient
or any other person.

An instruction is a direction which, if it is not followed, can


cause damage to the equipment described in this manual or any
other equipment or goods and can cause environmental
pollution.

A prohibition is a direction which, if it is not followed, can cause


damage to the equipment described in this manual or any other
equipment or goods and can cause environmental pollution.

Note: Notes provide advice and highlight unusual points. A note is


not intended as an instruction.

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10 | DR 100e (Digital Radiography) | Introduction to this Manual

System Documentation
The documentation shall be kept with the system for easy reference.
The most extensive configuration is described within this manual, including
the maximum number of options and accessories. Not every function, option
or accessory described may have been purchased or licensed on a particular
piece of equipment.
Technical documentation is available in the product service documentation
which is available from your local support organization.
The most recent version of this document is available on http://
www.agfahealthcare.com/global/en/library/index.jsp

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DR 100e (Digital Radiography) | Introduction to this Manual | 11

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

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12 | DR 100e (Digital Radiography) | Introduction

Introduction
Topics:

• Intended Use
• Intended User
• Configuration
• Operation Controls
• Messages
• Labels
• Installation
• Radiation Protection
• Cleaning and Disinfecting
• Patient data security
• Maintenance

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DR 100e (Digital Radiography) | Introduction | 13

Intended Use
The DR 100e digital system is a mobile 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, pediatric or neonatal 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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14 | DR 100e (Digital Radiography) | 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 100e (Digital Radiography) | Introduction | 15

Configuration
DR 100e is an integrated mobile Digital Radiography X-Ray System.

Figure 1: DR 100e mobile X-Ray System with rotating column (type 6012/004
or 6012/002)

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16 | DR 100e (Digital Radiography) | Introduction

Figure 2: DR 100e mobile X-Ray System with fixed column (type 6012/003 or
6012/001)

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DR 100e (Digital Radiography) | Introduction | 17

Operation Controls

6
7
1
2 8
3
9
4

1. Exposure button
2. Circuit breaker and equipotential node
3. Power supply cable reel
4. Rotating column
5. Lock of the arm movement during transport
6. X-ray generator and X-ray tube assembly
7. Goniometer
8. Collimator
9. X-ray tube handle

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18 | DR 100e (Digital Radiography) | Introduction

1
2

3
4
5
6
7
8

1. X-ray tube rotation movement lock


2. Arm
3. NX workstation with NX application and DR Detector Switch mounted on
a mounting bracket
4. Led beacon light
5. X-ray generator control panel
6. Handlebar with brake lever
7. Remote control receiver (optional)
8. DR detector holder
9. Tilting pedal
The operation controls on the system with fixed column are similar, apart
from the brake that is operated by pedals and not at the handlebar.

1. Brake pedals

Topics:

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DR 100e (Digital Radiography) | Introduction | 19

• NX Workstation (all-in-one PC)


• NX Application on the NX Workstation
• DR Detector Switch
• Portable DR Detector
• Circuit breaker
• X-ray generator control panel
• Manual Collimator
• Exposure button
• Infrared remote control
• Connectors for the hospital network and for registering a DR Detector
• Led beacon light

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20 | DR 100e (Digital Radiography) | Introduction

NX Workstation (all-in-one PC)

1 2 34

1. Speaker volume
2. Display on/off
3. Display brightness
4. Power button
Figure 3: Control buttons

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DR 100e (Digital Radiography) | Introduction | 21

NX Application on the NX Workstation


The NX application is used to define patient information, select exposures and
process images.

Figure 4: NX application

The operation of the NX application is described in the NX User Manual,


document 4420..

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22 | DR 100e (Digital Radiography) | Introduction

DR Detector Switch
The DR Detector Switch is available in the title bar of the NX application.
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.

Figure 5: DR Detector Switch

DR Detector Status

Battery status icon

Meaning Full Medium Low Empty

Connection status icon (wifi/


wired)

Meaning Good Low Bad Wired DR Detector

Panel status icon

(blinking) (blinking)

Meaning Ready Initializing exposure Starting up Error Sleep

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DR 100e (Digital Radiography) | Introduction | 23

Portable 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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24 | DR 100e (Digital Radiography) | Introduction

Circuit breaker

Figure 6: System with rotating column

Figure 7: System with fixed column

The equipment is protected by a circuit breaker against excessive mains


fluctuations.
To restore operation of the equipment after activation of the circuit breaker,
return the switch to position "I".

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DR 100e (Digital Radiography) | Introduction | 25

X-ray generator control panel


1 2 3 4 5

15 6
14
13 7
12

11 10 9 8
1. Mains power indicator light.
The indicator lights up when the device is connected to the mains and
powered.
2. Turn the device on.
3. Control panel display for device status, X-ray parameters and messages.
4. The indicator lights up when the device is ready for exposure.
5. The indicator lights up when exposure is ongoing.
6. Reset the alarm.
Return to the upper menu.
7. Function buttons for selecting a line on the display.
8. Modify the exposure settings for mAs.
9. Modify the exposure settings for kV.
10. Switch to manual exposure mode and open the list of anatomical
programs.
Scroll down.
11. Activate remote control.
The indicator lights up when the remote control is enabled.
12. Small focus and large focus.
The indicator light shows the active setting.
13. Moving grid.
The indicator lights up when the signal for the moving grid is enabled.
14. Collimator light.
After pressing the button, the light field indicating the collimated area and
the laser light indicating the center position remain lit for a few seconds
before automatically switching off.
15. Turn the device off.

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26 | DR 100e (Digital Radiography) | Introduction

Manual Collimator

6
5 1

4 2
3

1. Longitudinal collimation
2. Button to switch on the light field indicating the collimated area and the
laser light indicating the center position.
After pressing the button, they remain lit for a few seconds before
automatically switching off.
3. Rails to insert a DAP meter or a filter.
4. Measurement tape to measure the distance between the focal spot of X-ray
tube and the tabletop.
The measurement tape is at the rear side of the collimator.
5. Transversal collimation
6. Filter selection.
Another button to switch on the light field is available on the X-ray generator
control panel.

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DR 100e (Digital Radiography) | Introduction | 27

Exposure button
1 2

1. Step 1: preparation of the X-ray tube


2. Step 2: exposure
Figure 8: Exposure button

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28 | DR 100e (Digital Radiography) | Introduction

Infrared remote control

3 1
4 2

1. Transmission indicator (yellow)


2. Exposure button
3. Collimator light button
4. Battery status indicator (red)
Figure 9: Infrared remote control

The battery status indicator flashes once per second when the battery is near
the end of life and twice per second when the battery must be replaced.
The transmission indicator lights up when one of the two buttons is pressed.

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DR 100e (Digital Radiography) | Introduction | 29

Connectors for the hospital network and for registering a DR


Detector

1
2

1. USB port to connect the IR Data Communication Unit for registering a DR


Detector.
2. Network connector to connect the NX workstation to the hospital network.
3. Network connector to connect the Registration Cable for registering a DR
Detector.
Figure 10: System with rotating column

1
2

1. Network connector to connect the NX workstation to the hospital network.


2. USB port to connect the IR Data Communication Unit for registering a DR
Detector.
3. Network connector to connect the Registration Cable for registering a DR
Detector.
Figure 11: System with fixed column

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30 | DR 100e (Digital Radiography) | Introduction

Led beacon light

Figure 12: Led beacon light (green)

Table 1: Led beacon light

Color Meaning
Green The wireless DR Detector and the X-ray generator are ready for mak-
ing an exposure.
Yellow X-ray radiation is ongoing.

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DR 100e (Digital Radiography) | Introduction | 31

Messages
Under certain conditions the system sounds a signal or shows a message on
the display.
Topics:

• Sound signals
• Status messages
• Warning messages
• Error messages

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32 | DR 100e (Digital Radiography) | Introduction

Sound signals
Signal Description
2 beeps Successful storage of exposure parameters in an ana-
tomic program.
3 beeps X-ray exposure finished successfully
1 long beep (1 sec) Alarm or malfunction

Status messages
Message Description Action
READY The device is ready to
perform an exposure
WAITING Preparation phase Wait for the message in-
dicating that the device
is ready.
MANUAL
DAP READY Dosimeter ready

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DR 100e (Digital Radiography) | Introduction | 33

Warning messages
Warning messages must be reset using the reset button in order to continue
working.

Figure 13: Reset button

Message Description Action


CLOCK ERR. System clock error Press the reset button to
continue.
INI. APR APR checksum error Press the reset button to
continue.
ERROR IN APR An APR value is out of Change the value.
range
TUBE SEASONING After a long idle period Press the reset button to
(3 months or more) it is continue. Call Service
necessary to perform X- for the tube seasoning.
ray tube seasoning, to
avoid damage.
HOT TUBE The temperature of the Wait for the monobloc
X-ray tube has reached to cool down.
the maximum allowed
value.
EXPIRED TIME The exposure button Release the exposure
has been pressed half- button and repeat the X-
way for preparing the X- ray exposure sequence.
ray tube for more than
15 seconds.
MANUAL STOP The exposure button Press the reset button to
has been released be- continue.
fore the end of the ex-
posure.
INACTIVE DAP Dosimeter not connec- -
ted.

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34 | DR 100e (Digital Radiography) | Introduction

Message Description Action


MAX DOSE The doses counter has Press the F1 button and
reached the maximum the reset button to reset
value that can be dis- the value.
played.
DAP ERROR Dosimeter connected, Press the reset button
but in error. and call Service.
DAP RESET The sum of the DAP val- -
ues has been reset.

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DR 100e (Digital Radiography) | Introduction | 35

Error messages
Details on the contents of messages can be found in the service
documentation which is available to service personnel.
The device must be restarted in order to continue working.

Message Description Action


FAULTY POWER Error on the Charger or Switch off, wait some
Chopper. No energy minutes, switch on, if
available. the error appears gain
call Service.
ERROR V3 Absent V3 power sup- Switch off, wait some
ply. minutes, switch on, if
the error appears gain
call Service.
FILAMENT No filament current. Switch off, wait some
minutes, switch on, if
the error appears gain
call Service.
ERROR V2 Absent V2 power sup- Switch off, wait some
ply. minutes, switch on, if
the error appears gain
call Service.
LOCKED STARTER Error during the start- Press the reset button
ing up. and repeat the expo-
sure.
FAULTY CHOPPER Error in the chopper Press the reset button
and repeat the expo-
sure.
X-RAY ERROR The kV value has not Press the reset button
reached 75% of the re- and repeat the expo-
quested value within sure.
the first 10ms of expo-
sure.
MAX. TIME The maximum exposure Press the reset button
time has been reached. and repeat the expo-
sure.
DATA ERROR Memory error, data Switch off, wait some
checksum error. minutes, switch on, if
the error appears gain
call Service.

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36 | DR 100e (Digital Radiography) | Introduction

Message Description Action


INVERTER KV ERROR During the exposure, Press the reset button
the kV value has de- and repeat the expo-
creased under 75% or sure.
increased over 110% of
the requested value.
Unbalance in the high
voltage circuit during
the exposure
INV. OVERLOAD Power to the inverter is Press the reset button to
out of range. continue.
INVERTER ERROR IGBT drivers error. Press the reset button to
continue.
TUBE CALIB. ERR. Error of X-ray tube cali- Call Service.
bration.
XR HANDSWITCH ERR. Faulty exposure button. Check the integrity of
the exposure button,
switch off the device
and switch it on, try
again, if the error per-
sists call Service.

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DR 100e (Digital Radiography) | Introduction | 37

Labels
Topics:

• General
• Type label
• Labeling of the collimator

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38 | DR 100e (Digital Radiography) | Introduction

General
Always take into account the markings and labels provided on the inside and
outside of the machine. A brief overview of these markings and labels and
their meaning is given below.

Figure 14: Position of the labels, illustrated on a system with rotating column

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DR 100e (Digital Radiography) | Introduction | 39

Figure 15: Position of labels specific for system with fixed column

A
Information label for the handlebar op-
eration.

B
Overcoming of obstacles.

C
Transport position.

D
Exposure hand switch

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40 | DR 100e (Digital Radiography) | Introduction

E
Circuit breaker on and off positions.

F
Equipotential connector.

G
Connector for moving grid.

H
Left pedal brake lock.
Right pedal brake lock.
X-ray tube rotation lock.
By turning the knob clockwise, the rota-
tion unlocks.

I
USB connector.

L
Wired network connector.
This connector is used to connect to the
hospital network.

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DR 100e (Digital Radiography) | Introduction | 41

Type label
X-ray system

Figure 16: Example of type label

X-ray generator and X-ray tube assembly

Figure 17: Example of type label

The INMETRO label.

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42 | DR 100e (Digital Radiography) | Introduction

Labeling of the collimator


Figure 18: Example of type label The type label is located at the rear side
of the collimator.

(A) Laser openings


(B) Warning labels
Avoid exposure.
Radiation is emitted from this opening.

(A) Laser radiation symbol


(B) Warning label:
LED Radiation
Risk group 2 IEC 62471:2006
CAUTION: Do not stare at operating light
source. May be harmful to the eyes.

(A) Laser radiation symbol


(B) Warning label:
Laser Radiation
Do not stare into beam
Class 2 LASER product
IEC 60825-1:2007
Po ≤ 1mW; λ = 645 ±10nm

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DR 100e (Digital Radiography) | Introduction | 43

Installation
Installation and configuration is performed by an Agfa trained and authorized
service engineer. Contact your local support organization for more
information.
Do not use the device in areas where there is a risk of fire.
Topics:

• Labeling the DR Detectors


• Equipotential earth connection
• Electrostatic discharge

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44 | DR 100e (Digital Radiography) | Introduction

Labeling the DR Detectors


CAUTION:
Selecting the wrong DR detector can cause the need to retake
the image.

On a configuration with multiple wireless DR Detectors of the same type, it is


required to apply labeling to the DR Detector containing a unique nickname
for each DR Detector. The nicknames must be configured on the NX
workstation. The DR Detector Switch shows which DR Detector is active and
shows its status, by means of the nickname of the DR Detector.

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DR 100e (Digital Radiography) | Introduction | 45

Equipotential earth connection


The device is supplied with an equipotential earth connection point.
The device can only be used in areas that comply with local electrical safety
norms and in environments suitable for medical activities.
An additional equipotential earth connection is provided because the
equipment is movable and the reliability of the main equipotential earth
connection point can be insufficient.
It is only possible to use this equipment in rooms that comply with IEC norm
requirements.

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46 | DR 100e (Digital Radiography) | Introduction

Electrostatic discharge
CAUTION:
Always resort to static procedures, protections and appropriate
products before opening or during the handling of the
equipment. This equipment includes electrostatically sensitive
components. Non-compliance with electrostatic discharge
procedures may cause damages to the components. Such
damages to the components are not covered by any warranty.
The electrostatic discharge can cause a remarkable voltage that could cause
damages to printed circuit boards or to other equipment components.
Electrostatic discharge damages can accumulate and can initially not be
visible, such as a hardware failure, but can reduce performances. Therefore, it
is recommended to use proper electrostatic discharge handling procedures.
Electrostatic discharge can be due to low humidity or to the use of electrical
equipment on carpets, bedding and clothes.

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DR 100e (Digital Radiography) | Introduction | 47

Radiation Protection
X-ray radiation can cause serious damage to the health, therefore observe
great care and ensure that protection against X-ray exposure is always applied.
Some of the effects of X-ray radiation are cumulative and may extend over a
period of time. Therefore the X-ray operator should avoid exposure by X-ray
radiation at all times.
Objects in the path of the X-ray beam may produce scattered radiation. The
intensity depends on the energy and intensity of the X-ray exposure and the
material of the object. Protective measures have to be taken to prevent
exposure through scattered radiation.
Protective measures include:
• structural configuration of the X-ray room (e.g. lead shielded rooms)
• radiation protection for the operators (e.g. personal radiation dosimeters,
lead aprons, keep maximum distance from X-ray source, regular training,
etc.)
• protection of patients against unnecessary radiation (e.g. limitation of X-
ray field by collimation, lead shielding, lead aprons, etc.)

Monitoring of Personnel
The monitoring checks the amount of X-ray radiation the personnel has been
exposed to. It determines safety of the operators and it helps checking if safety
measures of the X-ray environment are adequate. Inadequate or improper
protection can lead to serious damage to the health.
To measure radiation, personal radiation dosimeters are typically used. They
are worn on the body at all times during working in an environment where X-
ray radiation is applied. They provide an indication for the amount of
radiation the operator was exposed to.

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48 | DR 100e (Digital Radiography) | Introduction

Cleaning and Disinfecting


All appropriate policies and procedures should be followed to avoid
contamination of the staff, patients and equipment. All existing universal
precautions should be extended to avoid potential contaminations and to
avoid patients coming into (close) contact with the device. The user is
responsible for selecting a disinfection procedure.
Topics:

• Cleaning
• Disinfecting
• Disinfecting safety directions
• Approved disinfectants

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DR 100e (Digital Radiography) | Introduction | 49

Cleaning
To clean the exterior of the equipment:

1. Stop the system.


CAUTION:
Wet cleaning of the equipment while it is connected to the
electric circuit includes the risk of electric shock and of short
circuit.
2. Wipe the exterior of the device with a clean, soft, damp cloth. Use a mild
soap or detergent if required. Do not use any corrosive, dissolving or
abrasive cleaning or polishing agents. Make sure no liquid gets in the
device.
CAUTION:
Clean the equipment with only a little moisture.

Note: Do not open the equipment for cleaning. No components


inside the device require cleaning by the user.

Using unsuitable cleaning agents or methods can damage the property


when surface becomes dull and brittle (e.g. alcohol-containing agents).
3. Start up the system.

Topics:
• Cleaning chromed parts
• Cleaning plastic surfaces
• Cleaning enemaled or aliminum parts

Cleaning chromed parts


Chromed parts must be cleaned only with a dry woolen cloth. Do not use
polishing abrasives. To protect the finish, use a nonabrasive wax.

Cleaning plastic surfaces


Plastic surfaces must be cleaned only with soap and water. When using other
cleaning agents (for example with a high alcohol content), the material can
become opaque or can break.

Cleaning enemaled or aliminum parts


Enameled parts and aluminum surfaces must be cleaned only with a damp
cloth and a mild detergent and then with a dry woolen cloth. Never use

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50 | DR 100e (Digital Radiography) | Introduction

scouring powders, solvents, abrasives detergents or polishing abrasive. Do not


use a special detergent if its properties are not sure.

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DR 100e (Digital Radiography) | Introduction | 51

Disinfecting
To disinfect the device, use only disinfectants and disinfection methods that
are approved by Agfa and that correspond to the national regulation and
guidelines as well as explosion protection. If you plan to use other
disinfectants, approval of Agfa is needed before use, as most disinfectants can
damage the device. UV disinfection is also not allowed.
Perform the procedure following the instructions for use, the disposal
instructions and the safety instructions of the selected disinfectants and tools
and of the hospital.

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52 | DR 100e (Digital Radiography) | Introduction

Disinfecting safety directions


WARNING:
Using a disinfectant that can form an explosive or flammable
gas mixtures is hazard to life and health because of explosion
risk. Switch the equipment off before disinfecting. Allow the gas
mixture to evaporate before switching the x-ray system back on.
To disinfect the device:
• Do not use any corrosive, soluble or gaseous disinfectants.
• Use of spray disinfection can cause malfunctions due to ingress of the
disinfectant into the equipment. Disinfect all parts of the unit, including
the accessories and connection cables by just wiping them. Switch off the
system and cover the cooled system carefully before performing a room
disinfection using nebuliser.
• Using unsuitable disinfectants can cause discoloration and damage of the
surface of the equipment.

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DR 100e (Digital Radiography) | Introduction | 53

Approved disinfectants
Refer to the Agfa website for specifications on the disinfectants that have been
found compatible with the cover material of the device and can be used on the
outer surface of the device.
http://www.agfahealthcare.com/global/en/library/overview.jsp?ID=41651138

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54 | DR 100e (Digital Radiography) | Introduction

Patient data security


The user must ensure that the patients’ legal requirements are met and that
the security of the patient data is guarded.
The user must define who can access patient data in which situations.
The user must have a strategy available on what to do with patient data in
case of a disaster.

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DR 100e (Digital Radiography) | Introduction | 55

Maintenance
Warning: Improper, irregular or lack of maintenance of the
equipment can lead to injuries to persons (e.g. by radiation
hazard) and property damage as a result of malfunctions
and defects of the equipment.

Warning: Wear of equipment due to excessively long


intervals between service may lead to personal injury and
property damage due to worn and unsafe parts.

Warning: Incorrect or defective spare parts may adversely


affect the safety of the system and lead to damages,
malfunctions or total failure. Use only original spare parts
provided by the manufacturer.

In order to assure a continuous and safe performance of the equipment, a


periodic maintenance program must be established. It is the owner’s
responsibility to supply or arrange for this service.
There are two levels of maintenance, the first consists of tasks which are
performed by the user/operator, and the second are those tasks to be
performed by qualified X-ray service personnel.
The manufacturer is responsible for safety features of its own products, only
provided that maintenance, repairs and modifications are performed
exclusively by the manufacturer's personnel or by personnel expressly
authorized by the manufacturer.
The manufacturer can't be considered responsible for any error, damage or
injury caused by improper use or lack of maintenance of the equipment.
Always consult the Agfa Service documentation and an AGFA trained and
authorized Service engineer for complete maintenance schedules.

Preventive maintenance schedule


The user must ensure that all checks are performed satisfactorily before using
the equipment for its intended purpose.

Table 2: Preventive maintenance by the user

Interval What to do?

Daily Check for defective lights, components, nameplates and damaged


warning signals, main cables and connectors.

Daily Check all cable and connectors for damage or breaking.

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56 | DR 100e (Digital Radiography) | Introduction

Check for lack of oil and unusual noises in high voltage generator.

Daily Check the locking and braking systems.

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DR 100e (Digital Radiography) | Training | 57

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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58 | DR 100e (Digital Radiography) | Safety Directions

Safety Directions
WARNING:
Only qualified and authorized personnel shall operate this
system. In this context ‘qualified’ means those persons legally
permitted to operate this equipment in the jurisdiction in which
the equipment is being used, and ‘authorized’ means those
persons 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.
WARNING:
Improper changes, additions, maintenance or repair of the
equipment or the software can lead to personal injury, electrical
shock and damage to the equipment. Safety is only guaranteed
when changes, additions, maintenance or repairs are carried out
by an Agfa certified field service engineer. A non certified
engineer performing a modification or service intervention on a
medical device, acts on his own responsibility and makes the
warranty void.
WARNING:
Do not use the device for any application before correctly
performing all regular checks and updating the periodical
maintenance. If it is sure or probable that any part of the device
is defective or wrongly adjusted, don't use it before performing
all repairs. The use of a device with defective parts or adjusted
in a wrong way, can expose the user or the patient to ionizing
radiations or to other dangers concerning safety. This can cause
serious or mortal physical injuries, or wrong diagnosis or
therapies.
WARNING:
Do not use the device for any application before reading,
understanding and assimilating all information about safety,
safety and emergency procedures specified in the current
chapter about Safety. The use of the equipment without a proper
knowledge of safety rules can cause serious or mortal physical
injuries, or wrong diagnosis or therapies.
WARNING:
If you are not sure to be able to use this device in a safe and
efficient way, don't use it. The use of this device without proper
and adequate training can cause serious or mortal physical
injuries or wrong diagnosis or therapies.

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DR 100e (Digital Radiography) | Safety Directions | 59

WARNING:
Do not use the device with patients if there is no adequate
understanding of its capabilities and functions. Using the device
without an adequate knowledge of its functioning can
compromise the efficacy and/or reduce the safety of the patient,
the user and other people nearby.
WARNING:
This equipment must be used only in compliance with the safety
instructions specified in this User Manual and exclusively for
intended purposes. Do not use the device for purpose other than
those for which it is intended. Do not use the device with other
products than the ones whose compatibility has been recognized
by the Manufacturer. The use of the device for purposes other
than the ones expected or with an incompatible product, can
cause serious or mortal physical injuries or wrong diagnosis or
therapies.
WARNING:
The device should not be used adjacent to other equipment and
if adjacent use is necessary, the device should be observed to
verify normal operation in the configuration in which it will be
used.
WARNING:
If the device doesn't work as usual or shows symptoms of a fault,
even if no error messages are displayed, contact your local
service organization for assistance.

WARNING:
System unavailability due to hardware or software failure. If the
product is used in critical clinical workflows, a backup system
has to be foreseen.

WARNING:
To avoid electric shocks and burns caused by use of the wrong
type of fire extinguisher, make sure that the fire extinguisher at
the site has been approved for use on electrical fires.

WARNING:
Before trying to extinguish the fire, the safety measure to be
taken is to separate the equipment from other electric power
sources and from all other sources in order to reduce the risk of
electrical shock.
WARNING:
Never try to remove, modify, exclude or obstruct any safety
feature on the device. An intervention on safety features can
cause serious physical injuries or even death.

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60 | DR 100e (Digital Radiography) | Safety Directions

WARNING:
Do not connect the equipment with anything other than
specified. Doing so may result in fire or electric shock.

WARNING:
To avoid risk of electric shock, do not remove any covers.
Changes, additions, maintenance or repairs must be carried out
by an Agfa certified field service engineer.

WARNING:
Do not remove protections or cables from the device, unless it is
expressly required in this User Manual, because inside are
dangerous electrical voltages. The removal of protections or
cables can cause mortal injuries or serious damages to the
people.
WARNING:
The device includes moving parts. The removal of protections
can cause serious or mortal physical injuries to people.

WARNING:
Do not block the ventilation ports to prevent overheating.
Overheating can cause system malfunction and damages.

WARNING:
Always double check your exposure parameter settings prior to
exposing the patient.

CAUTION:
Avoid unnecessary dose by checking before exposure if the DR
Detector Switch displays the name of the DR Detector that is
being used and if the status of the DR Detector is ready for
exposure.
CAUTION:
Avoid unnecessary dose by checking before exposure if the
beacon light lights up green.

CAUTION:
Excessive ambient temperature may impact the performance
and cause permanent damage to the device. If ambient
temperature and humidity is outside the range of 10 - 40 °C and
30 - 75% RH, do not operate the system or use air conditioning.
Warranty will be void if it is obvious that operating conditions
are not met.

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DR 100e (Digital Radiography) | Safety Directions | 61

CAUTION:
Damaged grid. Reduced image quality. Please handle the grids
with special care.

CAUTION:
Laser radiation is potentially dangerous for skin and eyes. Do
not stare directly or through optical instruments at the laser
beam. Do not point the laser beam on the face or the eyes of the
patient.
CAUTION:
Strictly observe all warnings, cautions, notes and safety
markings within this document and on the product.

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62 | DR 100e (Digital Radiography) | Basic Workflow

Basic Workflow
Topics:

• Starting the NX workstation and the DR Detector


• Retrieving the patient info
• Moving the unit
• Starting the device
• Positioning
• Selecting the exposure
• Preparing the exposure
• Checking the exposure settings
• Executing the exposure
• Performing a quality control
• Stopping the device
• Using the NX workstation with the X-ray system switched off
• Stopping the NX workstation and the DR Detector
• Using the ‘virtual keyboard’

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DR 100e (Digital Radiography) | Basic Workflow | 63

Starting the NX workstation and the DR Detector


The all-in-one PC and the DR Detector are battery powered. They can be
started while the X-ray device is switched off.

1. Switch on the all-in-one PC by pressing and holding the power button for 2
seconds.
For detailed information about starting up NX, refer to the NX User
Manual, document 4420.
2. Power on the DR Detector.
a) Attach a fully charged battery pack to the DR Detector.
b) Turn on the DR Detector.
c) If needed, register the DR Detector to the DR 100e system.
For detailed information about powering on the DR Detector, refer to the
DR Detector user manual.

Related Links
Connectors for the hospital network and for registering a DR Detector on page 29
NX Workstation (all-in-one PC) on page 20

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64 | DR 100e (Digital Radiography) | Basic Workflow

Retrieving the patient info


Note: If you use a wired network the network cable must be plugged
in to be able to perform this step.

1. On the RIS, schedule the examinations.


2. In NX, query the RIS.
3. Define the patient info for the examination.
4. Start the examination.

Note: If the patient cannot be retrieved from the RIS you should
enter patient data manually. In that case, you can use the ‘virtual
keyboard’.

Related Links
Connecting DR 100e to a wired network on page 97

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DR 100e (Digital Radiography) | Basic Workflow | 65

Moving the unit


CAUTION:
Risk of tilting during use or transport on inclined floors. Do not
use the unit on floors with an inclination higher than 5 degrees.
Do not drive the unit on ramps with an inclination higher than
10 degrees.
CAUTION:
The uncontrolled movement of the device could cause damages
to the operator, patient and personnel in proximity of it. The
equipment must be moved only after bring it to transport
position. For safe transport, switch off the equipment before
transporting it and ensure that all system peripherals (monitor,
mouse, keyboard, cables etc.) are disconnected.
To bring the device to transport position and move it:

1. Make sure the device is switched off.


a) Press the power off button.

Figure 19: Power off


b) Unplug the power supply cable.
c) Wind the mains cable on the cable reel.
2. Move the rotating column in central position.

The two arrows (A) on the foot of the column are aligned.

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66 | DR 100e (Digital Radiography) | Basic Workflow

3. Lower the arm (A) to locked position.

The lock (B) activates with a click. To assert that the arm is locked, turn
the knob with the arrow towards the red dot.
4. Put the X-ray tube (A) in vertical position on both rotation axes (B and C).

5. Turn the X-ray tube rotation handle (F) clockwise.


The device is now in transport position.
6. Release the brake.
• On a system with rotating column, release the brake by pulling the
lever on the handlebar.
• On a system with fixed column, release the brake pedal.
7. Move the unit holding the handlebar.
8. To overcome obstacles or small drops, press with the foot on the pedal for
the tilting and, at the same time, pull the handlebar.

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DR 100e (Digital Radiography) | Basic Workflow | 67

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68 | DR 100e (Digital Radiography) | Basic Workflow

Starting the device


1. Unroll the mains cable from the cable reel and extend it completely.
2. Plug the cable into a mains power socket.
The mains power indicator lights up. If the mains power indicator does not
light up, check if the switch of the circuit breaker on the front panel of the
device is in position "I".
3. Press the power button.

Figure 20: Power on

During the startup sequence, a sound signal is heard and the display and
indicator lights light up.
If a DAP meter is present, the status of the DAP meter is displayed.
If the DAP meter is not present or not working properly, an error message
is dispayed. To continue the startup, press the reset button. The DAP meter
is inactive.

Figure 21: Reset

While the device prepares, the busy status is displayed. It may take up to two
minutes for the ready status to appear.

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DR 100e (Digital Radiography) | Basic Workflow | 69

Positioning
WARNING:
Monitor the patient position (hands, feet, fingers, etc.) with
special care to avoid injury to the patient caused by unit
movements. Patient hands must be kept away from mobile
components of the unit. Intravenous tubing, catheters and other
patient connected lines should be routed away from moving
equipment.

1. Pull and rotate the knob (A) with the arrow towards the green dot to
unlock the arm.

2. Lift the arm.


3. Position the X-ray tube relative to the region of interest.
a) Move the device.
b) Rotate the column.

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70 | DR 100e (Digital Radiography) | Basic Workflow

4. Point the X-ray tube towards the region of interest.

The X-ray tube can be tilted in all directions:


• Forward up to 102 degrees (A)
• Backward up to 49 degrees (A)
• To the side up to 180 degrees (B)

The collimator can be rotated on its vertical axis up to 120 degrees in each
direction. To rotate the collimator, grip it with both hands and rotate in
the desired direction.

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DR 100e (Digital Radiography) | Basic Workflow | 71

Selecting the exposure


1. At the NX workstation, select the thumbnail for the exposure in the Image
Overview pane of the Examination window.
The default X-ray exposure parameters for the selected exposure are sent
to the modality and displayed on the X-ray generator control panel. The
control panel can be used to set different exposure parameters.
The selected DR Detector is activated.
The DR Detector Switch shows which DR Detector is active and shows its
status.
• Flashing: starting up
• Green (constant): ready for exposure
2. Adjust the exposure parameters.

Figure 22: kV and mAs

Figure 23: Small focus and large focus

Related Links
X-ray generator control panel on page 25

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72 | DR 100e (Digital Radiography) | Basic Workflow

Preparing the exposure


1. Check the position of the X-ray unit and the patient.
WARNING:
Liquids ingressing the DR Detector may cause malfunction
and contamination.

If there is a chance that the detector comes in contact with liquids (bodily
fluids, disinfectants,...), the DR Detector must be wrapped in a protective
plastic bag while performing the examination.
• If a filter is used, mount the filter to the collimator.
• If a grid is used, attach the grid to the detector.
2. Switch on the light localizer on the collimator. Adapt collimation if
required.

Figure 24: Collimator light

CAUTION:
Misalignment of the DR Detector and the X-ray tube causes
unnecessary exposure of the patient to radiation.

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DR 100e (Digital Radiography) | Basic Workflow | 73

Checking the exposure settings


Topics:

• On the NX application
• On a DR Detector that has a status indicator
• On the X-ray generator control panel
• On the control panel

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74 | DR 100e (Digital Radiography) | Basic Workflow

On the NX application
1. Check if the DR Detector Switch displays the name of the DR Detector
that's being used
2. If a wrong DR Detector is displayed, select the right DR Detector by
clicking the drop down arrow on the DR Detector Switch.

Related Links
DR Detector Switch on page 22

On a DR Detector that has a status indicator


Check if the status of the DR Detector is ready for exposure. If the status is
not ready for exposure, the DR Detector cannot be used for making an
exposure.

On the X-ray generator control panel


Check if the exposure settings displayed on the control panel are suitable
for the exposure.
If other exposure values are required than those defined in the NX exam,
use the control panel to overwrite the default defined exposure settings.

Related Links
X-ray generator control panel on page 25

On the control panel


WARNING:
Check if the led beacon light lights up green.

This indicates that the wireless DR Detector and the X-ray generator are
ready for making an exposure.

Related Links
Led beacon light on page 30

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DR 100e (Digital Radiography) | Basic Workflow | 75

Executing the exposure


1. Activate the preferred exposure control mode.

Figure 25: Switch between remote control exposure button or wired


exposure button.

The indicator lights up when the remote control is enabled.


Each exposure control mode excludes the other one.
2. Take a safe distance from the X-ray tube.
CAUTION:
Excessive user or operator radiation exposure. Always keep a
distance of at least 2 meters from the focal spot and X-ray
beam, protect body and do not expose hands, arms or other
parts of the body to the primary beam.
3. Execute the exposure.
When the X-ray exposure is finished successfully, three beeps are heard.
Note: Letting the exposure button go ends the exposure
immediately and the exposure can be underexposed. Press the
reset button to repeat the exposure.

WARNING:
During exposure ionizing radiation is emitted by the X-ray
system. To indicate the presence of ionizing radiation, the
radiation indicator on the control console lights up.

CAUTION:
Do not select another thumbnail until the preview image is
visible in the active thumbnail. The acquired image may be
linked to the wrong exposure.

The exposure time is displayed in ms.


The image is acquired from the DR Detector and displayed in the
thumbnail.
The actual X-ray exposure parameters are shown in the Image Detail pane.
If collimation is applied, the image is automatically cropped at the
collimation borders.
The device prepares for a next exposure.

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76 | DR 100e (Digital Radiography) | Basic Workflow

Topics:

• Using the wired exposure button


• Using the remote control exposure button

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DR 100e (Digital Radiography) | Basic Workflow | 77

Using the wired exposure button


Completely extend the cable of the exposure button and keep as fas as possible
from the radiation source. The cable of the exposure button can be extended
up to 4 m. Stretching it further can damage the cable.

1. Press and hold the exposure button down to the first pressure point.
The X-ray tube is prepared for performing an exposure.
To start the exposure directly after preparation of the X-ray tube has
ended, immediately press the exposure button down fully.
2. Press the exposure button down fully and keep it pressed until the
exposure has ended.
When the X-ray exposure is finished successfully, three beeps are heard.
WARNING:
During exposure ionizing radiation is emitted by the X-ray
system. To indicate the presence of ionizing radiation, the
radiation indicator on the control console lights up.

Related Links
Exposure button on page 27

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78 | DR 100e (Digital Radiography) | Basic Workflow

Using the remote control exposure button


The remote control is optional.
Ensure that there is no other equipment with remote control nearby.
Keep as fas as possible from the radiation source. The remote control operates
at a distance of maximum 11 m from the device at any angle and within sight,
through glass or leaded glass. The remote control doesn't operate through
doors or walls.

1. Point the remote control towards the remote control receiver on the
device.
2. Press and release the exposure button on the remote control.
The X-ray tube is prepared for performing an exposure.
3. Press the exposure button withing 15 seconds and keep it pressed until the
exposure has ended.
When the X-ray exposure is finished successfully, three beeps are heard.
WARNING:
During exposure ionizing radiation is emitted by the X-ray
system. To indicate the presence of ionizing radiation, the
radiation indicator on the control console lights up.
4. Return the remote control to its cradle.
The remote control produces a sound signal if it is not returned to its
cradle after three minutes.

Related Links
Infrared remote control on page 28

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DR 100e (Digital Radiography) | Basic Workflow | 79

Performing a quality control


In NX:

1. Select the image on which quality control is to be performed.


2. Prepare the image for diagnosis by using e.g. L/R markers or annotations.
3. If the image is OK, send the image to a hardcopy printer and/or PACS
(Picture Archiving and Communication System).
Note: If you use a wired network, NX can only send images if
the network cable is plugged in.

Note: If you use a wired network, NX may display error


messages while working unplugged because it cannot send
images. To prevent error messages being displayed, halt the
send queue and restart it when plugging in the network cable.
Refer to the NX User Manual.

Related Links
Connecting DR 100e to a wired network on page 97

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80 | DR 100e (Digital Radiography) | Basic Workflow

Stopping the device


CAUTION:
Risk of damaging the device. Always grip the plug to disconnect
the power cable. Don't disconnect the plug by pulling the cable.
Handle connectors with care.

1. Bring the device to transport position.


2. Press the power off button.

Figure 26: Power off


3. Unplug the power supply cable.
4. Wind the mains cable on the cable reel.
5. Move the device to the location where a next exposure is planned or to a
suitable place for parking.

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DR 100e (Digital Radiography) | Basic Workflow | 81

Using the NX workstation with the X-ray system


switched off
The NX workstation can be left on while the X-ray device is switched off, for a
limited period of time, less than ten minutes, e.g. for moving the device to the
next patient.
When the NX workstation must be operated while the X-ray device is switched
off for a longer period of time, e.g. for processing the images, the mains cable
must be plugged in to a mains socket while operating the NX workstation.
When stopping the NX workstation, also disconnect the mains cable from the
mains socket.
Related Links
Connecting DR 100e to a wired network on page 97

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82 | DR 100e (Digital Radiography) | Basic Workflow

Stopping the NX workstation and the DR Detector


1. On the NX workstation, go to the Main Menu.
2. Click the Show Desktop action button.
The Windows desktop is shown.
3. Go to the Windows Start menu and select Shut down.
The NX application is stopped.
The all-in-one PC is switched off.
4. Switch off the DR Detector.
For detailed information about switching off the DR Detector, refer to the
DR Detector user manual.
5. Charge the battery of the DR Detector.
For detailed information about charging the battery of the DR Detector,
refer to the DR Detector user manual.

Related Links
NX Workstation (all-in-one PC) on page 20

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DR 100e (Digital Radiography) | Basic Workflow | 83

Using the ‘virtual keyboard’


When selecting a text field, the virtual keyboard is displayed:

Button Function
Enter button

Close button

Floating virtual keyboard button

After entering text, select another text field to continue typing or hide the
virtual keyboard by clicking the Enter button.
If the virtual keyboard is not displayed automatically or if the virtual keyboard
is in the way, click the floating virtual keyboard button.

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84 | DR 100e (Digital Radiography) | Basic Workflow

Note: Clicking the Close button may cause the virtual keyboard
to remain hidden when entering the text field again.

Restriction on the use of virtual keyboard software


DR 100e contains software components licensed from Comfort Software
Group. These products may only be used as part of and in connection with DR
100e.

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DR 100e (Digital Radiography) | Advanced Operation | 85

Advanced Operation
Topics:

• Using a moving grid


• Using a DAP meter
• Hanging a leaded apron
• Making an exposure using a cassette
• Modifying the exposure parameters of an anatomic program

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86 | DR 100e (Digital Radiography) | Advanced Operation

Using a moving grid


CAUTION:
The connected examination table or the bucky must be in
compliance with IEC 60601-1 standard and must be connected
to the equipment according to 93/42/CE medical devices
directive and following amendments.

1. Connect the examination table or the bucky.

Figure 27: Connector for moving grid on a system with rotating column

Figure 28: Connector for moving grid on a system with fixed column
2. Activate the moving grid.

Figure 29: Activate moving grid

The indicator lights up when the signal for the moving grid is enabled.
3. Prepare the exposure.
4. Execute the exposure.
If exposure is blocked, check the error messages and the connection to the
bucky.

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DR 100e (Digital Radiography) | Advanced Operation | 87

Using a DAP meter


CAUTION:
The installation and maintenance of the DAP meter can be
performed only by authorized service personnel.

The function of the DAP meter is to measure the dose-area product (μGy.m2)
that is going out towards the patient, accumulated over all exposures.

1. Before starting the examination of a patient, reset the DAP value by


pressing the F1 and reset button simultaneously.

Figure 30: Reset the DAP value


2. Perform the examination by performing all exposures for the patient.
After each exposure, the DAP value is incremented by the measured dose.
3. Read the accumulated DAP value on the first line of the display.

Figure 31: DAP value

DAP value on the NX workstation


The DAP value for each exposure is sent to the NX application and stored with
the image. A new exposure resets the DAP value.

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88 | DR 100e (Digital Radiography) | Advanced Operation

Hanging a leaded apron


CAUTION:
The weight of a leaded apron hanging on the arm or directly on
the X-ray tube assembly, could cause uncontrolled movements
of the arm and trouble of positioning. Don't hang a leaded apron
to the arm. Use only the proper hanger.

1
2

1. Apron hanger.
2. Leaded apron.

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DR 100e (Digital Radiography) | Advanced Operation | 89

Making an exposure using a cassette


To make an exposure using a CR cassette, the manual exposure mode can be
activated. Exposure parameters are set using the X-ray generator control panel
by selecting an anatomic program or by entering exposure parameters for a
free exposure. No image will be acquired on the NX workstation.

Figure 32: Switch to manual exposure mode and open the list of anatomical
programs

Figure 33: Free exposure

Setting the exposure parameters on the X-ray generator control


panel
1. Set the exposure parameters for an anatomic program.
For making a free exposure, continue with the next step, adjusting the
exposure parameters.
a) Press the button to open the list of anatomic programs.

Figure 34: Anatomic programs

An anatomic group is displayed on the first line of the display, with the
anatomic programs listed below.
b) To switch to another anatomic group, press the F1 button on the
console repeatedly.

Figure 35: Select anatomic group


c) To scroll down the list of anatomic programs, press the button to scroll
pages.

0365B EN 20181015 0853


90 | DR 100e (Digital Radiography) | Advanced Operation

Figure 36: Scroll pages


d) Select an anatomic program by pressing the F2, F3 or F4 buttons,
corresponding to the line on the display containing the selected
program.

Figure 37: Select anatomic program

The selected anatomic group, anatomic program and exposure


parameters are displayed. The exposure parameters can still be
adjusted.
2. Adjust the exposure parameters.

Figure 38: kV and mAs

Figure 39: Small focus and large focus

• To return to the list of anatomic programs, press the F2 button.

Figure 40: Return to anatomic program list


• To leave the anatomic program and make a free exposure, press the
reset button.

Figure 41: Reset

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DR 100e (Digital Radiography) | Advanced Operation | 91

3. Check the position of the X-ray unit and the patient.


4. Apply the required filter on the collimator.
5. Switch on the light localizer on the collimator. Adapt collimation if
required.

Figure 42: Collimator light

Related Links
Anatomic program exposure parameters on page 108
Modifying the exposure parameters of an anatomic program on page 92
X-ray generator control panel on page 25

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92 | DR 100e (Digital Radiography) | Advanced Operation

Modifying the exposure parameters of an anatomic


program
The anatomic program consists of six groups of six sets of exposure
parameters, so 36 in total. The default X-ray exposure parameters for each
exposure type can be customized.

1. Press the button to open the list of anatomic programs.

Figure 43: Anatomic programs

An anatomic group is displayed on the first line of the display, with the
anatomic programs listed below.
2. Select the anatomic program for which new exposure parameters are
required.

Figure 44: Select anatomic group

Figure 45: Scroll pages

Figure 46: Select anatomic program


3. Adjust the exposure parameters.

Figure 47: kV and mAs

0365B EN 20181015 0853


DR 100e (Digital Radiography) | Advanced Operation | 93

Figure 48: Small focus and large focus


4. Press and hold the F3 button and simultanuously press the anatomic
programs button.

Figure 49: Store exposure parameters

The system sounds two beeps.

The new exposure parameters are stored in the anatomic program.

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94 | DR 100e (Digital Radiography) | Product Information

Product Information
Topics:

• Options and Accessories


• Compatibility
• Compliance
• Connectivity
• Equipment Classification
• Product Complaints
• Environmental protection
• Technical Data
• Remarks for HF-emission and immunity

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DR 100e (Digital Radiography) | Product Information | 95

Options and Accessories


• Infrared remote control
• DAP meter
• Second capacitor bank

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.

Compliance
Topics:

• General
• Safety
• Electromagnetic Compatibility
• Laser Safety

0365B EN 20181015 0853


96 | DR 100e (Digital Radiography) | Product Information

General
• The product has been designed in accordance with the MEDDEV
Guidelines relating to the application of Medical Devices and have been
tested as part of the conformity assessment procedures required by
93/42/EEC Medical Device Directive (European Council Directive
93/42/EEC on Medical Devices).

Safety
• IEC 60601-1

Electromagnetic Compatibility
• IEC 60601-1-2

Laser Safety
• IEC 60825-1

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DR 100e (Digital Radiography) | Product Information | 97

Connectivity
DR 100e requires a TCP/IP network to exchange information with a number of
other devices. The recommended minimum network performance is 100 Mbit
for wired ethernet and IEEE 802.11 g for wireless network.
Note: A wireless network operating on variable speed or subject to
interruptions will cause delays on the NX workstation.

DR 100e communicates with other devices in the hospital network using one
of the following protocols:
• DICOM
• IHE
DR 100e can be connected to a RIS system (input scheduling), a PACS system
(output image/data management) and to a hardcopy device (output image).

Connecting DR 100e to a wired network


To connect DX-D 100 to a wired network:

1. Place the unit in parking position.


2. Connect a network cable to the connector for the hospital network and
plug it into a network socket.

Figure 50: Wired network connector

Related Links
Connectors for the hospital network and for registering a DR Detector on page 29

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98 | DR 100e (Digital Radiography) | Product Information

Equipment Classification
Per EN/IEC60601-1, Medical Electrical Equipment, General Requirements for
Safety 3rd Edition, this device is classified as following:

Table 3: Equipment classification

Class I equip- Equipment in which protection against electric shock does


ment not relay on basic insulation only, but includes a power sup-
ply cord with protective earth conductor. For earth reliability
always plug the main power cord into an earthed mains
power outlet.

Type B equip- A Type B piece of equipment is one that provides a particular


ment degree of protection against electric shock particularly re-
garding allowable leakage current and reliability of the pro-
tective earth protection.

Water ingress IPX0


This device does not have protection against ingress of wa-
ter.

Cleaning See section on cleaning and disinfecting.

Disinfection See section on cleaning and disinfecting.

Flammable The equipment is not type AP or APG.


anesthetics
This device is not suitable for use in the presence of a flam-
mable anesthetic mixture with air, or in presence of a flam-
mable anesthetic mixture with oxygen or nitrous oxide.

Operation Continuous operation with intermittent load.

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DR 100e (Digital Radiography) | Product Information | 99

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 +32 3 444 7094

0365B EN 20181015 0853


100 | DR 100e (Digital Radiography) | Product Information

Environmental protection

Figure 51: WEEE symbol

Figure 52: Battery symbol

WEEE end user notice


The directive on Waste Electrical and Electronic Equipment (WEEE) aims to
prevent the generation of electric and electronic waste and to promote the
reuse, recycling and other forms of recovery. It therefore requires the
collection of WEEE, recovery and reuse or recycling.
Due to the implementation into national law, specific requirements can be
different within the European Member States. The WEEE symbol on the
products, and/or accompanying documents means that used electrical and
electronic products should not be treated as, or mixed with general household
waste. For more detailed information about take-back and recycling of this
product please contact your local service organization and/or dealer. By
ensuring this product is disposed of correctly, you will help prevent potential
negative consequences for the environment and human health, which could
otherwise be caused by inappropriate waste handling of this product. The
recycling of materials will help to conserve natural resources.

Battery notice
The battery symbol on the products, and/or accompanying documents means
that the used batteries should not be treated as, or mixed with general
household waste. The battery symbol on batteries or its packaging may be
used in combination with a chemical symbol. In cases where a chemical
symbol is available it indicates the presence of respective chemical substances.
If your equipment or replaced spare parts contain batteries or accumulators
please dispose of them separately according to local regulations.
For battery replacements please contact your local sales organization.

0365B EN 20181015 0853


DR 100e (Digital Radiography) | Product Information | 101

Technical Data
Topics:

• DR 100e
• Anatomic program exposure parameters
• DAP meter
• Collimator
• X-ray generator and X-ray tube assembly

0365B EN 20181015 0853


102 | DR 100e (Digital Radiography) | Product Information

DR 100e
Electrical connection

Rated power supply 115 ÷ 230Vac ±10%, 50/60 Hz ± 5


Hz, 10A, standard monophase with
ground conductor.
Automatic setting of the equipment
according to mains voltage.
Automatic line compensation.
Standard outlet 16 A @ 230Vac
Line resistance <1 Ω @ 115/230Vac
Power supply cable 8m
Infrared remote control 2 x 1.5 V alkaline battery, 2500mAh
Battery life > 25000 exposures
Radiological data
Nominal power (IEC 60601-1) 32 kW @ 100 kV, 320 mA, 100 ms
kV values 40 - 125 kV at steps of 1 kV
kV accuracy ±5% (IEC 60601-2-54)
mA values @115/230Vac 50 - 400 mA
mA accuracy @115/230Vac ±10% (IEC 60601-2-54)
mAs values @115/230Vac 0.1 - 220 mAs
mAs accuracy ±10% (IEC 60601-2-54)
Exposure times @115/230Vac 0.001 - 2.2 s according to mAs
Time accuracy ±10% (IEC 60601-2-54)
Max mAs
40 kV max. 220 mAs
(the optional second capacitor bank is
required)
41 - 45 kV max. 200 mAs
46 - 52 kV max. 180 mAs
53 - 62 kV max. 160 mAs
63 - 72 kV max. 140 mAs

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DR 100e (Digital Radiography) | Product Information | 103

73 - 92 kV max. 110 mAs


93 - 112 kV max. 100 mAs
113 - 125 kV max. 90 mAs
X-ray filtration
Filtration without DAP meter 3.1 mm Al @75kV
Filtration including DAP meter 3.4 mm Al @75kV
Product life

Estimated product life (if regularly Up to ten (10) years


serviced and maintained according
to Agfa instructions)

Topics:

• Dimensions
• Environmental conditions

Dimensions
Table 4: Dimensions of the system with rotating column

Dimensions

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104 | DR 100e (Digital Radiography) | Product Information

All dimensions are in mm. Linear tolerances ±5 mm, angular ±1°.

Dimensions (in transport position) 700 x 1489 x 1504 mm


width x length x height
Handlebar height 932 mm

Weight 240 kg
(without DR detector)

Focus-floor distance (Z-axis) 444 mm - 2153 mm

Maximum height 2393 mm

0365B EN 20181015 0853


DR 100e (Digital Radiography) | Product Information | 105

Maximum lateral extension of the 747 mm


arm

Rotation of the column (β-swivel) ± 90°

Rotation of the monobloc around ± 180°


the arm axis (α swivel)

Rotation of the monobloc around 151° (102° ahead, 49° back)


its axis (γ swivel)

Movement manual with dead man parking brake

Wheels diameter front: swiveling double wheel Ø100


mm, width 20 mm
rear: wheel Ø300mm, width 45mm

Table 5: Dimensions of the system with fixed column

Dimensions

0365B EN 20181015 0853


106 | DR 100e (Digital Radiography) | Product Information

All dimensions are in mm. Linear tolerances ±5 mm, angular ±1°.

Dimensions (in transport position) 618 x 1366 x 1483 mm


width x length x height
Handle height 949 mm

Weight 170 kg
(without DR detector)

Focus-floor distance (Z-axis) 417 mm - 2092 mm

Maximum height 2333 mm

Rotation of the monobloc around the ± 180°


arm axis (α swivel)

Rotation of the monobloc around its 151° (102° ahead, 49° back)
axis (γ swivel)

0365B EN 20181015 0853


DR 100e (Digital Radiography) | Product Information | 107

Movement manual

Wheels diameter front: 80 mm


rear: 250 mm

Environmental conditions
Table 6: Environmental conditions of the mobile X-ray unit

Environmental conditions (during normal operation)

Room temperature between +10 °C and +40 °C

Humidity (non condensing) between 30% and 75% RH


(non-condensing)

Atmospheric pressure between 700 hPa and 1060 hPa

Environmental conditions (during storage)

Temperature (ambient) between -25 °C and +70 °C

Humidity (non condensing) between 10% and 90%


(non-condensing)

Atmospheric pressure between 500 and 1060 hPa

Overall system environmental conditions


For overall system environmental conditions, the environmental conditions of
the portable DR detector should be taken into account. Refer to the DR
Detector User Manual for environmental conditions for the DR detector.

0365B EN 20181015 0853


108 | DR 100e (Digital Radiography) | Product Information

Anatomic program exposure parameters


The default X-ray exposure parameters for each exposure type can be
customized. The device is delivered with a set of X-ray exposure parameters
that are intended as a guideline. The default X-ray exposure parameters are
only starting points that can be replaced by more specific X-ray exposure
parameters developed by the operator.
In the following table the dose values are expressed in µGym2 (Dose Area
Product), the exposures are set with standard values for clinical investigations
on the patient and performed with the X-ray tube with a SID of 100 cm and
without grid.
The dose measurement has been performed according to IEC 60601-1-3 §
5.2.4.2 with the dosimetric chamber supplied with the equipment and the
collimator completely open.

Table 7: Anatomic group for examinations of the body

Anatomic Focus kV mAs µGym2


program
Chest AP Large 110 2 17.83
Abdomen AP Large 81 16 76.37
Abdomen Large 90 20 118.94
LAT
Chest LAT Large 110 4 34.63
Sternum Small 85 4 22.84
Ribs Small 70 6.3 24.12

Table 8: Anatomic group for examinations of the skull/spine

Anatomic Focus kV mAs µGym2


program
Skull AP Small 77 10 46.71
Thora. Spine Small 77 20 93.97
AP
Lumbar Large 81 20 104.10
Spine AP
Cervical Small 66 8 27.07
Spine

0365B EN 20181015 0853


DR 100e (Digital Radiography) | Product Information | 109

Anatomic Focus kV mAs µGym2


program
Thora, Spine Large 81 16 76.39
LAT
Lumbar Large 90 20 118.84
Spine LAT

Table 9: Anatomic group for examinations of the upper extremities

Anatomic Focus kV mAs µGym2


program
Clavicle Small 66 5 16.81
Humerus Small 60 3.2 8.56
Elbow Small 55 4 8.53
Forearm Small 55 2 4.27
Wrist Small 50 2 3.25
Hand/ Small 46 1.6 1.99
Fingers

Table 10: Anatomic group for examinations of the lower extremities

Anatomic Focus kV mAs µGym2


program
Hip/Femur Small 81 12.5 64.73
Knee Small 63 5 15.07
Kneecap Small 63 8 24.18
Leg/Ankle Small 60 4 10.69
Foot Small 48 2 2.85
Toes Small 44 2 2.12

Table 11: Anatomic group for examinations of children (I)

Additional filter 1 mm Al + 0.2 mm Cu or 1 mm Al + 0.1 mm Cu

Anatomic Focus kV mAs µGym2


program
Chest 0.5 kg Small 60 0.1 0.14
Chest 1.0 kg Small 60 0.2 0.24

0365B EN 20181015 0853


110 | DR 100e (Digital Radiography) | Product Information

Anatomic Focus kV mAs µGym2


program
Chest 2.0 kg Small 60 0.32 0.37
Chest 3.0 kg Small 62 0.4 0.54
Chest 4.0 kg Small 65 0.4 0.63
Chest 5.0 kg Small 68 0.4 0.75

Table 12: Anatomic group for examinations of children (II)

Additional filter 1 mm Al + 0.2 mm Cu or 1 mm Al + 0.1 mm Cu

Anatomic Focus kV mAs µGym2


program
Chest 8,0 kg Small 76 0.4 1.08
Abdomen 4,5 Small 65 2 3.19
kg
Abdomen 8,0 Small 65 3.2 5.13
kg
Chest 10 kg Small 76 0.8 2.18
Abdomen 10 Small 70 2 4.16
kg
Abdomen 15 Small 70 4 8.36
kg

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DR 100e (Digital Radiography) | Product Information | 111

DAP meter
Model Diamentor CI-P
Type Device for the dose area product meas-
urement in X-ray diagnostics according
to IEC 60580 standard.
Principle of measurement Radiation measure with ionization
chamber
Measured quantity Dose area product
Digital resolution 0.01 μGym2
Max linearity error < 2.5%
Nominal range of dose-area prod- (0.01 - 2500) μGym2/s
uct rate
Equivalent filtration of the cham- 0.3 mm Al
ber @75kV
Max measurement field 118 mm x 118 mm
Dimensions (W x D x H) 152 mm x 234 mm x 23 mm
Weight 455 g

0365B EN 20181015 0853


112 | DR 100e (Digital Radiography) | Product Information

Collimator
Model R108 F
Collimation Manual with internal light source,
multilayer, squared field.
Assembly plan from focus 80 mm (3.14")
Coverage of the field at 100cm FFD minimum 0 cm x 0 cm
(SID)
maximum 43 cm x 43 cm
Lighting source Clusters of high-brightness LED pow-
er
Lamp lighting time 30 s
Light intensity (IEC 60601-2-54) > 160 lux
Minimum contrast ratio (IEC 4:1
60601-2-54)
Focal distance measurement Retractable tape measure (maximum
extension 3 m)
Inherent filtration 2 mm equivalent Al at 75kV
Additional filtration Manual selection
• 0 mm Al
• 1 mm Al + 0.1 mm Cu
• 1 mm Al + 0.2 mm Cu
• 2 mm Al

Rotation ± 120°
Weight 5.5 kg
Laser field to determine the focal dis-
tance at 1 m

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DR 100e (Digital Radiography) | Product Information | 113

X-ray generator and X-ray tube assembly


Table 13: X-ray generator and X-ray tube assembly

Model name
Rotating anode monobloc MHF2030
High voltage generator
Thermo-tinned structure
Max. power (100 kV - 320 32 kW
mA)
Max. voltage to the tube 125 kV
Max. current to the tube 450 mA
Ripple to the max. power < 1%
Rise time to the max. < 2 ms
power
Performance
According to the load curves of the x-ray tube
Housing
Min. inherent filtration 1.1 mm Al
@75 kV
Dimensions (W x D x H) 320 mm x 140 mm x 324.5 mm x 145 mm x
241 mm 244.5 mm
Weight 19.4 kg 18.7 kg
Thermal features
Thermal capacity 500 kJ 600 kJ
Thermal safety 60 °C ± 5° C
Thermal switch normally closed
Lung 0.16 dm3 0.2 dm3
Continuous thermal dissi- 55 W 60 W
pation
Max. housing tempera- 60 °C
ture
Heating curves (50 W, 100 W, 200 W, 300 W) and cooling curve (***)

0365B EN 20181015 0853


114 | DR 100e (Digital Radiography) | Product Information

Figure 53: X22 0.8/1.3

Figure 54: X22 0.6/1.3

Table 14: X-ray tube

Model name
Rotating anode X22 0.8/1.3 X22 0.6/1.3
Specifications
X-ray tube X22
Rotation speed 3000 min‾¹
Nominal High voltage 130 kVp
Nominal focus dim. (IEC 0.8 mm small focus 0.6 mm small focus
60336)

0365B EN 20181015 0853


DR 100e (Digital Radiography) | Product Information | 115

1.3 mm large focus 1.3 mm large focus


Nominal anodic power 16 kW small focus 11 kW small focus
(IEC 60613)
32 kW large focus 32 kW large focus
Anodic material RT (Focus track: Tung- RTM
sten-Rhenium),
TZM (Anode mass: mo-
lybdenum + titanium +
zirconium)
Anodic diameter 64 mm (2.52 inch)
Anodic angle 15°
Thermal capacity of the 80 kJ (107 kHU)
anode
Max continuous anode dis- 300 W
sipation
Min. inherent filtration 0.7 mm Al eq.
(IEC 522)
Tube material glass

Figure 55: X22 0.8/1.3

0365B EN 20181015 0853


116 | DR 100e (Digital Radiography) | Product Information

CURVE DI CARICO SINGOLO - SINGLE LOAD RATING - ABAQUE DE CHARGE UNIQUE CURVE DI CARICO SINGOLO - SINGLE LOAD RATING - ABAQUE DE CHARGE UNIQUE
0.6 - 3 ~ - 3000 min-1 1.3 - 3 ~ - 3000 min-1
250 700

Corrente Anodica - Tube Current - Intensité Anodique

Corrente Anodica - Tube Current - Intensité Anodique


600
200

500
50 kV 50 kV
60 kV 60 kV
150
70 kV 400 70 kV
80 kV 80 kV
(mA)

(mA)
90 kV 90 kV
100 kV 300 100 kV
100 110 kV 110 kV
120 kV 120 kV
130 kV 200 130 kV

50
100

0 0
0.01 0.1 1 10 0.01 0.1 1 10
Tempo di esposizione - Time - Temps (sec) Tempo di esposizione - Time - Temps (sec)

Figure 56: X22 0.6/1.3

0365B EN 20181015 0853


DR 100e (Digital Radiography) | Product Information | 117

Remarks for HF-emission and immunity


It is hereby certified that the device has interference suppression according to
the EN 55011 Class A as well as the FCC Rules CR47 Part 15 Class A.
This device was tested for a normal hospital environment as described above.
The user of the device should ensure that it is used in such an environment.
This equipment has been tested and found to comply with the limits for a
Class A digital device, pursuant to part 15 of the FCC Rules. These limits are
designed to provide reasonable protection against harmful interference when
the equipment is operated in a commercial environment. This equipment
generates, uses and can radiate radio frequency energy and, if not installed
and used in accordance with the instruction manual, may cause harmful
interference to radio communications. Operation of this equipment in a
residential area is likely to cause harmful interference in which case the user
will be required to correct the interference at his own expense.
WARNING:
This device is intended for use by healthcare professionals only.
This device may cause radio interference or may disrupt the
operation of nearby equipment. It may be necessary to take
mitigation measures, such as re-orienting or relocating the
device or shielding the location.
WARNING:
The HF-emission and immunity can be influenced by connected
data cables depending on length and the manner of installation.

This device is intended for operation in the electromagnetic environment


given below. The user of the device should ensure that it is used in such
an environment.

RF Emission Agree- Electromagnetic Environment Guidelines


Measurements ment

High frequency Group 1 The device uses high frequency energy exclu-
RF emissions in sively for its internal functions. For this reason,
accordance with its high frequency RF emission is very low and
CISPR 11 it is improbable that neighboring electronic
equipment will be disrupted.

High frequency Class A The emissions characteristics of this equipment


RF emissions in make it suitable for use in industrial areas and
accordance with hospitals (CISPR 11 class A). If it is used in a
CISPR 11 residential environment (for which CISPR 11
class B is normally required) this equipment
might not offer adequate protection to radio-

0365B EN 20181015 0853


118 | DR 100e (Digital Radiography) | Product Information

Harmonic emis- Class A frequency communication services. The user


sion in accord- might need to take mitigation measures, such
ance with IEC as relocating or re-orienting the equipment.
61000-3-2

Voltage fluctua- Fulfilled


tions / flickering
in accordance
with IEC
61000-3-3

The device is used in a professional healthcare / radiological environment.


Environmental conditions are stated in the user manual.
This device was tested for a professional healthcare environment as described
above. Nevertheless the HF-emission and immunity can be influenced by
connected data cables depending on length and the manner of installation.
This device is intended for operation in the electromagnetic environment
given below. The user of the device should ensure that it is used in such
an environment.

Resistance to Jam- Test level of profes- Electromagnetic Environ-


ming Test sional medical ment Guidelines
equipment and ba-
sic EMC standards

Discharge of static + 8 kV contact dis- Floors should consist of


electricity in accord- charge wood, concrete or ceramic
ance with IEC tiles. The relative humidity
+ 15 kV air dis-
610004-2 must be at least 30%, if the
charge
floor is made of synthetic
material.

Fast transient electri- + 2 kV mains The quality of the voltage


cal disturbance varia- supplied should correspond
+ 1 kV data lines
bles / bursts in accord- to a typical commercial or
ance with IEC clinical environment.
610004-4

Impulse voltages + 1 kV line-line volt- The quality of the voltage


(surges) in accordance age supplied should correspond
with IEC 61000-4-5 to that of a typical commer-
+ 2 kV line-ground
cial or clinical environment.
voltage

Voltage breakdown, • 0% Ur for ½ peri- The quality of the voltage


short term interrup- od supply should correspond to
tions and variations in • 0% Ur for 1 peri- that of a typical commercial
the voltage supplied in od or clinical environment.
• 70% Ur (30%
breakdown of

0365B EN 20181015 0853


DR 100e (Digital Radiography) | Product Information | 119

accordance with IEC Ur) for 25 peri- If the user wants the device
61000-4-11 ods at 0° to work continuously, even
• 0% Ur for 250 pe- when the energy supply is
riods interrupted, it is recommen-
ded to use an energy supply
free of interruptions or a
battery.

Magnetic field at the 30 A/m Magnetic field at the net-


supply frequency work frequency should cor-
(50/60 Hz) in accord- respond to the typical values
ance with IEC as they are in a
61000-4-8
commercial and clinical en-
vironment.

REMARK : Ur is the alternating current in the network before the application


of the test level.

This device is intended for operation in the electromagnetic environment


given below. The user of the device should ensure that it is used in such
an environment.

Tests of Resistance to Dis- Test level of profes- Electromagnetic Envi-


ruption sional medical ronment
equipment and ba-
Recommended protec-
sic EMC standards
tive distance:

Conducted high frequency 6 V rms in ISM fre-


disturbance variables in ac- quency bands be-
cordance with IEC tween 150 kHz and
61000-4-6 80 MHz

Radiated high frequency 3 V/m


disturbance variables in ac-
80 MHz to 2.7 GHz
cordance with IEC
61000-4-3

RF communication 28 V/m

Disruptions are possi-


ble near devices that
carry the following
symbol:

The field strength of stationary transmitters, such as base stations of radio


telephones, mobile broadcasts for rural areas, amateur stations, and AM and

0365B EN 20181015 0853


120 | DR 100e (Digital Radiography) | Product Information

FM radio transmitters, cannot be precisely predetermined theoretically. An


investigation of the location is recommended, to ascertain the electromagnetic
environment as a result of stationary high frequency transmitters. If the field
strength of the device exceeds the test level given above, the device must be
observed with regard to its normal operation at each place of use. In case of
unusual performance characteristics, it can be necessary to take additional
measures, such as the re-orientation of the device, for example.
This device is intended for operation in an electromagnetic environment
in which the radiated high frequency disturbance variables are
monitored. The user of the device can help to prevent electromagnetic
disruptions by maintaining the minimum distances between portable
and mobile high frequency communication equipment (transmitters) and
the device as recommended below, in accordance with the maximum
output power of the communications equipment. See also the section
with precautions on EMC.

Recommended Protective Distances between Portable and Mobile High


Frequency Communication Equipment and the Device

Rated Power of Protective Distance in accordance with RF emission Fre-


the Transmitter quency
W m

150 kHz to 80 80 MHz to 800 800 MHz to 2.7


MHz MHz GHz

d = 1.0 d = 0.3 d = 0.3

0.01 0.1 0.05 0.05

0.1 0.32 0.1 0.1

1 1.0 0.3 0.3

10 3.2 1.0 1.0

The distance can be determined through the equation for each respective
column.
P is the rated power of the transmitter in watts (W) according to the manu-
facturer information on the transmitter, only for transmitters where the rat-
ed power is not mentioned in the above table.
REMARK : These Guidelines may not be relevant in all situations. The dis-
persion of electromagnetic waves is influenced by absorption and reflections
from buildings, objects and people.

Topics:

• Enclosure Port Immunity to RF wireless communication equipment

0365B EN 20181015 0853


DR 100e (Digital Radiography) | Product Information | 121

• Precautions on EMC
• Cables, transducers and accessories

0365B EN 20181015 0853


122 | DR 100e (Digital Radiography) | Product Information

Enclosure Port Immunity to RF wireless communication


equipment
Band Service Distance Immunity
test level
(MHz) (m)
(V/m)
300-390 TETRA 400 0.3 27
430-470 GMRS 460; FRS 460 0.3 28
704-787 LTE Band 13, 17 0.3 9
800-960 GSM 800/900; TETRA 800, IDEN 0.3 28
820; COMA 850; LTE Band 5
1700-1990 GSM 1800; COMA 1900; GSM 1900; 0.3 28
DECT; LTE Band 1, 3, 4, 25; UMTS
2400-2570 Bluetooth; WLAN; 802.11 b/g/n; 0.3 28
RFID 2450; LTE Band 7
5100-5800 WLAN 802.11 a/n 0.3 9

0365B EN 20181015 0853


DR 100e (Digital Radiography) | Product Information | 123

Precautions on EMC
WARNING:
The system should not be used adjacent to or stacked with other
equipment and if adjacent or stacked use is necessary, the
system should be observed to verify normal operation in the
configuration in which it will be used.
CAUTION:
Portable RF communications equipment (including peripherals
such as antenna cables and external antennas) should be used
no closer than 30 cm (12 inches) to any part of the system,
including cables specified by the manufacturer. Otherwise,
degradation of the performance of this equipment could result.

0365B EN 20181015 0853


124 | DR 100e (Digital Radiography) | Product Information

Cables, transducers and accessories


Cables, transducers and accessories which were tested and found to comply
with the collateral standard IEC60601-1-2 (EMC):
CAUTION:
Using cables and accessories not mentioned in this manual or
spare parts not ordered from Agfa, may cause a higher emission
of electromagnetic phenomena and/or may rise the
susceptibility against it.

function type; remark

maximum length

network con- Network cable CAT5e F/UTP (shielded end) with shielded
nection RJ45;
10 m
(or original Agfa cable F7.0477.1052; 5m)

No additional accessories available.

0365B EN 20181015 0853

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