User Manual: Pixium 2430 EZ

DR 10s
Pixium 2430 EZ
User Manual
0351A EN 20190319 1349 *

ii | DR 10s | Contents
Contents
Legal Notice .......................................................................... 5
Introduction to this Manual ................................................... 6
Scope .........................................................................7
About the safety notices in this document .................. 8
Disclaimer ................................................................. 9
Introduction to the DR Detector ........................................... 10
Intended Use ............................................................11
Indications for Use ................................................... 11
Intended User .......................................................... 11
Configuration .......................................................... 12
Equipment Classification ..........................................14
Non-medical equipment ...............................14
Options and Accessories ...........................................16
Operation Controls .................................................. 17
DR 10s ......................................................... 18
DR Detector Battery Charger ........................ 19
DR Detector Switch on the NX Workstation ....
20
IR Data Communication Unit ....................... 22
Wireless Access Point ................................... 23
Using the Toggle Wifi button in the NX software to
switch between the wireless DR Detector and the
wireless hospital network .............................24
System Documentation ............................................25
Wireless access point ...................................25
Training ...................................................................26
Product Complaints ................................................. 27
Compatibility ...........................................................28
Compliance ............................................................. 29
General ........................................................30
Safety .......................................................... 30
Electromagnetic Compatibility .....................30
Radio Frequency .......................................... 31
Connectivity ............................................................ 33
Wireless Communication ............................. 33
Installation .............................................................. 34
Environment of Use ..................................... 34
Messages ................................................................. 36
Labels ...................................................................... 37
Additional Labeling of the DR Detector ........ 40
Additional Labeling of the DR Detector battery
41
charger ........................................................ 42
Consulting the About box .............................43
0351A EN 20190319 1349 *

DR 10s | Contents | iii
Cleaning and Disinfecting ........................................ 44

Cleaning ...................................................... 45
Use of protective plastic bag .........................46
Disinfecting ................................................. 47
Approved disinfectants ................................ 48
Safety directions for disinfection .................. 49
Maintenance ............................................................50
Daily inspection ........................................... 51
Yearly inspection ..........................................52
Regular Inspection and Maintenance ........... 53
Replacement Parts Support ..........................54
Repair ..........................................................55
Patient data security ................................................ 56
Environmental Protection ........................................ 57
Safety Directions ......................................................58
DR Detector Battery ..................................... 62
Safety directions for the power supply ..........64
Getting started .....................................................................66
Starting the DR Detector .......................................... 67
Basic Workflow DR Detector .................................... 69
Step 1: retrieve the patient info ....................70
Step 2: select the exposure ...........................70
Step 3: prepare the exposure ........................71
Step 4: check the exposure settings .............. 72
Step 5: execute the exposure ........................73
Positioning the DR Detector ......................... 74
Guidelines for Pediatric Applications ........................76
Stopping the DR Detector .........................................78
Automatically turning the DR Detector to sleep
79
Automatically turning off DR Detector ......... 79
Automatic exposure detection ..................................80
Advanced Operating ............................................................ 81
Detector Status Indicators ........................................82
Charging a battery ................................................... 83
Inserting the battery in the battery charger ....
84
Battery charger indicator lights ....................85
First use of a new battery ......................................... 87
Storing a battery ...................................................... 88
Storage conditions ....................................... 88
Sharing the DR Detector between NX Workstations ....
89
Registering the DR Detector to an NX Workstation
using automatic registration ........................ 90
Registering the DR Detector to an NX Workstation
using the DR 10s DR 14s Registration Tool ... 91
Problem solving ................................................................... 93
Artifact in DR Detector images ................................. 94
Identifying problems ................................................95
0351A EN 20190319 1349 *

iv | DR 10s | Contents
Battery thermal protection ...........................96

Technical Data ..................................................................... 97
DR 10s ..................................................................... 98
X-ray performance ....................................... 99
DR 10s, DR 14s Battery ...........................................101
DR 10s, DR 14s Battery Charger ............................. 102
Remarks for HF-emission and immunity ............................ 103
EMC (Electromagnetic Compatibility) Statements ..104
Precautions on EMC ...............................................105
Electromagnetic emissions ..................................... 106
Electromagnetic immunity ..................................... 107
Recommended separation distance ........................ 111
For U.S.A. .............................................................. 112
0351A EN 20190319 1349 *

DR 10s | Legal Notice | 5
Legal Notice
0459
THALES AVS FRANCE SAS, 460 rue du Pommarin, 38430 MOIRANS

FRANCE
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 10s and DR 14s 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 2019 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
0351A EN 20190319 1349 *

6 | DR 10s | Introduction to this Manual
Introduction to this Manual

Topics:
• Scope
• About the safety notices in this document
• Disclaimer
0351A EN 20190319 1349 *

DR 10s | Introduction to this Manual | 7
Scope
This manual contains information for the safe and effective operation of the
DR 10s DR Detector and peripheral equipment, further referred to as the DR
Detector.
0351A EN 20190319 1349 *

8 | DR 10s | Introduction to this Manual
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.
0351A EN 20190319 1349 *

DR 10s | Introduction to this Manual | 9
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.
0351A EN 20190319 1349 *

10 | DR 10s | Introduction to the DR Detector
Introduction to the DR Detector

Topics:
• Intended Use
• Indications for Use
• Intended User
• Configuration
• Equipment Classification
• Options and Accessories
• Operation Controls
• System Documentation
• Training
• Product Complaints
• Compatibility
• Compliance
• Connectivity
• Installation
• Messages
• Labels
• Cleaning and Disinfecting
• Maintenance
• Patient data security
• Environmental Protection
• Safety Directions
0351A EN 20190319 1349 *

DR 10s | Introduction to the DR Detector | 11
Intended Use
The DR Detector is a wireless radiographic digital X-ray imaging device
commonly referred to as flat panel detector. It is designed for general
radiography applications. The DR Detector will be used in a radiological
environment by qualified staff to capture and route static X-ray images.
The DR Detector is not intended for mammography applications.
Indications for Use

The DR Retrofit solution is indicated for use in general projection
radiographic applications to capture for display diagnostic quality
radiographic images of human anatomy. The DR Retrofit solution may be used
wherever conventional screen-film systems may be used.
The DR Retrofit solution is not indicated for use in mammography.
Intended User
This manual is written for trained users of Agfa products. Users are considered
as the persons who actually handle the equipment as well as the persons
having 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.
Only a physician or a legally certified operator should use this product.
0351A EN 20190319 1349 *

Configuration
The DR Detector is a component that can be integrated in an X-ray system and
that communicates to a workstation. Multiple DR Detectors can communicate
to a single workstation.
2
1. DR Detector
2. DR Detector battery
3. DR Detector battery charger
4. IR data communication unit
5. Wireless access point
6. Network switch
7. Workstation
Figure 1: DR Detector configuration
1 2
3
0351A EN 20190319 1349 *
1. X-ray generator synchronization through the DR Generator Sync Box

2. Automatic exposure detection
Figure 2: DR Detector configuration variants
Related Links
Automatic exposure detection on page 80
0351A EN 20190319 1349 *

Equipment Classification
Per EN/IEC60601-1, Medical Electrical Equipment, General Requirements for
Safety 3rd Edition, the DR Detector, including the battery pack, is classified as
following.
Class I equipment Internally powered
Type B equipment A Type B piece of equipment is one that provides a

particular degree of protection against electric shock
particularly regarding allowable leakage current and
reliability of the protective earth protection.
Applied Parts The DR Detector tube side is an applied part.

Water ingress IP43
Protection against spraying water.
Flammable anesthet- This device is not suitable for use in the presence of a
ics flammable anesthetic mixture with air, or in pres-
ence of a flammable anesthetic mixture with oxygen
or nitrous oxide.
Operation Continuous operation.
Estimated product Up to ten (10) years

life (if regularly serv-
The minimal total dose that the panel shall absorb
iced and maintained
during its lifetime is 100 Gy at RQA5
according to Agfa in-
structions)
Non-medical equipment
Following components are classified as non-medical equipment:
• DR Detector battery charger
• IR data communication unit
• Wireless access point
• Network switch
• Workstation
• DR Generator Sync Box
WARNING:
Do not use non-medical equipment in the patient’s vicinity.
0351A EN 20190319 1349 *

Figure 3: Patient’s vicinity
0351A EN 20190319 1349 *

Options and Accessories

• DR Detector battery
• DR Detector battery charger
The delivery contains a set of labels. When using multiple DR Detector, on the
labels a nickname is written to identify the DR Detector. An identical label is
attached to the bucky of the X-ray system to identify the dedicated workspace
of each DR Detector.
0351A EN 20190319 1349 *

Operation Controls
Topics:
• DR 10s
• DR Detector Battery Charger
• DR Detector Switch on the NX Workstation
• IR Data Communication Unit
• Wireless Access Point
• Using the Toggle Wifi button in the NX software to switch between the
wireless DR Detector and the wireless hospital network
0351A EN 20190319 1349 *

DR 10s
1 3 4
2
5
1. Effective imaging area border and center position indication

2. Control panel
3. DR Detector battery lock lever
4. DR Detector battery
5. Antenna of the wireless network adapter
Figure 4: DR Detector operation controls
1 2 3
4 5 6 7 6
1. Battery indicator
2. Wifi indicator
3. Status indicator
4. IR data port: communication port for the detector link (registration/
connection).
5. On/off switch
6. Magnets for DR Detector connector
7. DR Detector cable connector
Figure 5: DR Detector control panel
Related Links
Detector Status Indicators on page 82
0351A EN 20190319 1349 *

DR Detector Battery Charger

The battery charger has three slots to insert a battery.
1. Battery status indicator light

Figure 6: DR Detector Battery Charger
Related Links
Charging a battery on page 83
DR 10s, DR 14s Battery on page 101
DR 10s, DR 14s Battery Charger on page 102
Safety directions for the power supply on page 64
Non-medical equipment on page 14
0351A EN 20190319 1349 *

DR Detector Switch on the NX Workstation

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.
It is positioned in the title bar of the NX application.
Battery status (empty)

icon
Meaning Full Medium Low Empty Wired DR Detector

Wireless DR Detector is off
or disconnected
Connec- (empty)
tion status
icon (wi-
fi/wired)
Meaning Good Low Bad Wired DR DR Detec-

Detector tor is off or
disconnec-
ted
DR Detec- (empty)
tor status
icon
(blinking)
0351A EN 20190319 1349 *

Meaning DR Detec- DR Detector is DR Detector is DR Detector is

tor is ready initializing for off or discon- inactive (no
for expo- exposure nected or in thumbnail se-
sure error lected)
DR Detector exposure synchronization
Automatic expo- (empty)

sure detection
icon
Meaning The active DR Detector is The active DR Detector is

using automatic exposure using X-ray generator syn-
detection chronization
Note: Depending on the installed software version, the icon may

not be displayed.
0351A EN 20190319 1349 *

IR Data Communication Unit

This unit is used as an interface of the NX workstation for infrared
communication with the DR Detector, which registers the DR Detector to the
NX workstation.
Related Links
Registering the DR Detector to an NX Workstation using automatic registration
on page 90
0351A EN 20190319 1349 *

Wireless Access Point

This antenna equipment relays captured images from the DR Detector to the
NX workstation.
Related Links
0351A EN 20190319 1349 *

Using the Toggle Wifi button in the NX software to switch

between the wireless DR Detector and the wireless hospital
network
The NX Workstation can be configured to use a wireless DR Detector and to
connect to a wireless hospital network.
In a configuration without a wireless access point that is connected to the
workstation, the DR Detector communicates via the internal wireless adapter
of the workstation and only one connection can be active at a time.The user
must manually switch between the wireless connection to the hospital
network and the wireless connection to the DR Detector.
To switch between wireless networks:
1. Press the Toggle Wifi button in the NX software.
Toggle Wifi
Wifi
The name and location of the button depends on the configuration.
Toggle
Toggle Wifi
Toggle Wifi
Toggle Wifi
Toggle Wifi
Figure 7: Action button to switch between wireless networks
A dialog is displayed indicating which network is currently active.

2. Press the icon representing the other netwok to activate it.
Table 1: Status of the wireless network
The NX Workstation is connected to the DR Detector to

make exposures.
No communication to the hospital network is possible, e.g.
to RIS or PACS.
The NX Workstation is connected to the hospital network to

retrieve data from the RIS or to print or archive images.
No communication to the DR Detector is possible, no expo-
sures can be performed.
0351A EN 20190319 1349 *

System Documentation
The documentation consists of a User manual (this document) and related
documentation:
• NX User Manual (4420).
• NX Key User Manual (4421).
• NX Getting Started Sheets (4424).
• NX Problem Solving Sheets (4425).
• DX-D DR Detector Calibration Key User Manual (0134).
• DX-D System User Documentation (if applicable).
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
Wireless access point

The wireless access point is delivered with its own user documentation.
0351A EN 20190319 1349 *

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.
0351A EN 20190319 1349 *

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
0351A EN 20190319 1349 *

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.
0351A EN 20190319 1349 *

Compliance
Topics:
• General
• Safety
• Electromagnetic Compatibility
• Radio Frequency
0351A EN 20190319 1349 *

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).
• ISO 14971
Safety
• IEC 60601-1
• UL 60601-1
• CAN.CSA-C22.2 No. 601.1
Electromagnetic Compatibility
• IEC 60601-1-2
0351A EN 20190319 1349 *

Radio Frequency
Declaration of conformity
Argentina Marca: Trixell / Modelo: DNUR-S2 / CNC ID: C-13463

Australia and New EMC standards
Zealand
Brazil ANATEL This product contains the board DNUR-S2,
ANATEL ID: 1248-14-4386
Canada IC RSS-210
Chile Certificate no: 647/DFRS12357/F-50
China SRRC Certificate no: CMIIT ID: 2013AJ7137
European Union RED directive
(and EEA)
India WPC WING ETA certificate No.: NER-ETA/200
WPC WING ETA certificate No.: NER-ETA/199
Japan R 207-643809
5Ghz product for indoor use only
Kuwait Certificate no: MC/M/3/6-13714
Malaysia SIRIM Approval no. RCCU/05A/S(14-0616)
Mexico IFETEL Certificate no: IFT: RCPTRDN13-1686
Russia Declaration of conformity No. D-RD-2801 of
01.04.2014, valid till 01.04.2020, registered in Federal
Communication Agency on 07.04.2014
Saudi Arabi Certificate no: 20131224058
Singapore Complies with IDA Standards DA103787
registration number: N3210-13
South Korea KCC Certificate no: KCC-RMM-TXL-Pixium3543EZ
Taiwan NCC Certificate no: CCAI13LP1720T6
Thailand Certificate no: JM 5401
The Philippines NTC Type Accepted No.: ESD-1408587C
United Arab Emi- TRA Registered No: ER0131569/14 Dealer no:
rates DA0067151/11
U.S.A. FCC Part 15 Class B
0351A EN 20190319 1349 *

Related Links
Remarks for HF-emission and immunity on page 103
Topics:
• Local regulations
• Restrictions on outdoor use
Local regulations
This product complies with local radio frequency regulations in the country or
region where you purchased the product. Note that it cannot be used in any
areas other than the country or region of its purchase.
The radio frequency channel (5 GHz) configured for indoor use may not be
usable in outdoor areas, depending on local radio frequency regulations.
If you would like to add other equipment to the environment where this
product is installed, or to use this product in other environments, please
consult your sales representative or local dealer for details.
Restrictions on outdoor use

There are restrictions on the outdoor use of the U-NII Low (5150-5250 MHz)
and U-NII Mid (5250-5350 MHz) bandwidths of the WLAN module
incorporated in the device in the following Member States: Belgium (BE),
Bulgaria (BG), Czech Republic (CZ), Denmark (DK), Germany (DE), Estonia
(EE), Ireland (IE), Greece (EL), Spain (ES), France (FR), Croatia (HR), Italy
(IT), Cyprus (CY), Latvia (LV), Lithuania (LT), Luxembourg (LU), Hungary
(HU), Malta (MT), Netherlands (NL), Austria (AT), Poland (PL), Portugal
(PT), Romania (RO), Slovenia (SI), Slovakia (SK), Finland (FI), Sweden (SE)
and United Kingdom (UK).
0351A EN 20190319 1349 *

Connectivity
Wireless Communication
Wireless communication is established between the internal wireless module
of the DR Detector and the NX workstation via the wireless access point. The
DR Detector is compliant with IEEE 802.11n (2.4 GHz/5 GHz). The available
frequency band varies depending on local radio laws and system
requirements. The frequency band (channel) of the DR Detector is selected at
installation.
Note: Use of multiple pieces of equipment that use the same
frequency band (channel) may interfere with each wireless
communication and cause a decline in transmission speed.
Note: Before introducing other wireless equipment to the same

environment where the DR Detector is set up, consult the system
engineer or qualified personnel at the medical site.
Note: Do not place obstacles in the way of the wireless access point
or of the antenna of the internal wireless module of the DR
Detector. Otherwise, the properties of wireless communication,
such as the throughput and operable distance, may decrease.
Note: Transmitting the image data to the NX workstation takes a

number of seconds. After making an exposure, stay with the
detector in the direct neighbourhood of the wireless access point
until the image is available on the NX workstation.
0351A EN 20190319 1349 *

Installation
Installation and configuration is performed by an Agfa trained and authorized
service engineer. Contact your local support organization for more
information.
On a configuration with multiple 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.
An identical label is attached to the bucky of the X-ray system to identify the
dedicated workspace of each DR Detector.
Environment of Use
The equipment is mainly for use in X-ray exposure rooms, hospital wards and
mobile medical examination vehicles. To use it in other places, consult your
sales representative or local Agfa dealer.
WARNING:
Do not install or store the equipment in any of the locations
listed below. Doing so may result in failure or malfunction,
equipment falling, or fire or injury:
• Close to facilities where water is used

• Where it will be exposed to direct sunlight
• Close to the air outlet of an air-conditioner or ventilation equipment
• Close to a heat source such as a heater
• In a dusty environment
• In a saline or sulfurous environment
• Where temperature or humidity is high
• Where there is freezing or condensation
• In areas prone to vibration
• On an incline or in an unstable area
Note: Do not use the detector near devices generating a strong
magnetic field. Doing so may produce image noise or artifacts.
Note: Do not use this equipment in combination with peripherals

such as defibrillators or large electric motors as these may cause
power-supply noise or power supply voltage variations. Doing so
may prevent normal operation of this equipment and peripherals.
0351A EN 20190319 1349 *

Note: This product may malfunction due to electromagnetic waves

caused by portable personal telephones, transceivers, radio-
controlled toys, etc. Be sure to avoid having objects such as these,
which affect this product, brought near the product.
CAUTION:
Sudden heating of the room in cold areas will cause
condensation to form on the equipment. In this case, wait until
the condensation evaporates before use. If the equipment is
used while condensation is formed on it, problems may occur.
When an air-conditioner is used, be sure to raise/lower the
temperature gradually so that a difference in temperature in the
room and in the equipment does not occur, to prevent
condensation.
Related Links
0351A EN 20190319 1349 *

Messages
Under certain conditions the DR Detector shows a dialog box containing a
message in the middle of the screen of the NX workstation. This message
informs the user that either a problem has occurred or that a requested action
cannot be performed. The user must read these messages carefully. They will
provide information on what to do from then on. This will be either
performing an action to resolve the problem or to contact the local service
organization. Details on the contents of messages can be found in the service
documentation which is available to local service personnel.
Related Links
Problem solving on page 93
0351A EN 20190319 1349 *

Labels
Symbol Explanation
Tube side
Direct current
Alternating current
Protective earth (ground)
This mark indicates that this is a Type B Equipment
Protection against harmful ingress of water or particu-

late matter. IP Classification: Ordinary.
Handle with care
Maximum patient weight over the whole area of the

detector surface
100kg Maximum patient weight on an area 80 mm in diame-

ter
Device contains a transmitter module that generates

non-ionizing radiation.
Manufacturer
Date of manufacture
Serial number
0351A EN 20190319 1349 *

Symbol Explanation
This mark shows compliance of the equipment with Di-

rective 93/42/EEC (for European Union).
CE non harmonized frequency marking
FCC Declaration of Conformity label
This mark shows compliance with both Canadian and

U.S. safety requirements.
Recognized Component Mark for Canada and the Uni-

ted States
This mark shows the compliance with EMC standards.

(For Australia and New Zealand)
This mark shows the compliance with EMC standards.

(For Australia and New Zealand)
This symbol on the products, and/or accompanying

documents means that used electrical and electronic
products should not be treated as, or mixed with gener-
al household waste.
This wheeled bin symbol on the products, and/or ac-

companying documents means that the used batteries
should not be treated as, or mixed with general house-
hold waste.
Recycling identification mark for lithium ion batteries

in Japan
This mark shows the compliance with China RoHS for 5

years.
Recycling mark in Taiwan
0351A EN 20190319 1349 *

Symbol Explanation
Read and understand all instructions and warning la-

bels in the product documentation before using the
equipment. Keep manual for future reference.
Safety warning, indicating that the manuals should be

consulted.
General warning, caution, risk of danger.
General Mandatory action.
Topics:
• Additional Labeling of the DR Detector

• Additional Labeling of the DR Detector battery
• Additional Labeling of the DR Detector battery charger
• Consulting the About box
0351A EN 20190319 1349 *

Additional Labeling of the DR Detector

Type label on the back
side of the DR Detec-
tor.
3
Figure 8: Sample of type label
Secondary label on the

back side of the DR De-
tector.
DR Detector identification label

Label Meaning
1 Writable label to identify and dedicate a DR Detector to an X-

ray system bucky.
0351A EN 20190319 1349 *


Type label on the back
side of the battery.
Secondary label on the

back side of the bat-
tery.
0351A EN 20190319 1349 *

Additional Labeling of the DR Detector battery charger

Type label on the bottom side of the battery
charger.
0351A EN 20190319 1349 *

Consulting the About box

1. Click About the solution in the Tools section of the Main Menu window
on the NX workstation.
Figure 11: Main Menu window.
This will open the About box showing the current release and version
details of the DR Retrofit solution and the XRDI software.
Figure 12: DR Retrofit About box (Displayed data may be different).
Note: Always quote these details when you discuss any issues
with Agfa service personnel.
2. Click on the dialog to close it.
0351A EN 20190319 1349 *

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
• Use of protective plastic bag
• Disinfecting
• Approved disinfectants
• Safety directions for disinfection
0351A EN 20190319 1349 *

Cleaning
To clean the exterior of the equipment:
1. Stop the system

WARNING:
When the equipment is going to be cleaned, be sure to turn
OFF the power of each device, and to unplug the power cord
from the AC outlet. Never use anhydrous or high solvency
alcohols, benzine, thinner or any other flammable cleaning
agent. Otherwise, it may result in fire or electric shock.
2. Wipe the exterior of the system with a cloth slightly moistened with a
neutral detergent. Some approved disinfectants can be used for cleaning
as well.
CAUTION:
Make sure no liquid gets in the device.
CAUTION:
Clean the equipment with only a little moisture. Do not
spray disinfectants or detergents directly on the equipment.
Do not pour liquid directly on the equipment.
CAUTION:
Liquids ingressing the DR Detector or the battery may cause
malfunction and contamination. Take special care near the
battery bay and near the cable connector on the side of the
DR Detector.
CAUTION:
Do not use abrasive brush and scraper to clean the product.
Note: Do not open the equipment for cleaning. No

components inside the device require cleaning by the user.
3. Start up the system.
Related Links
Approved disinfectants on page 48
0351A EN 20190319 1349 *

Use of protective plastic bag

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.
It is considered good clinical practice to use a single-use protective bag in all
cases where contact of the device or contaminants is expected, to avoid
contamination of others.
Make sure that the plastic bag is not wrinkled to avoid the creases showing in
the image.
0351A EN 20190319 1349 *

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.
Items contaminated with blood or body fluids, which may contain blood-
borne pathogens, should be cleaned and then receive intermediate level
disinfection with a product having an EPA-registered claim for activity against
hepatitis B.
0351A EN 20190319 1349 *

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
0351A EN 20190319 1349 *

Safety directions for disinfection

WARNING:
When the equipment is going to be cleaned, be sure to turn OFF
the power of each device, and to unplug the power cord from
the AC outlet. Otherwise, it may result in fire or electric shock.
WARNING:
Do not pour liquid directly on the equipment. Always use a
clean, low-linting cloth dampened (not dripping) with the
solution.
WARNING:
Use in well-ventilated areas.
WARNING:
Do follow the instructions of use as provided with the cleaning
or disinfection product.
WARNING:
Consult the manufacturer’s Material Safety Data Sheets (MSDS)
and recommendations on the product label for additional
information prior to use.
CAUTION:
Clean the equipment with only a little moisture. Do not spray
disinfectants or detergents directly on the equipment. Do not
pour liquid directly on the equipment.
CAUTION:
Be sure that all surfaces are thoroughly dry before returning the
equipment to use.
CAUTION:
Make sure that the equipment is properly decontaminated and
disinfected before shipment or servicing.
0351A EN 20190319 1349 *

Maintenance
Always consult the Agfa Service documentation and an Agfa trained and
authorized service engineer for complete maintenance schedules.
In order to ensure that the equipment is used safely and normally, be sure to
inspect the equipment before use. If any problem is found during the
inspection and cannot be corrected, please contact your sales representative
or local dealer.
Topics:
• Daily inspection
• Yearly inspection
• Regular Inspection and Maintenance
• Replacement Parts Support
• Repair
0351A EN 20190319 1349 *

Daily inspection
WARNING:
For safety reasons, be sure to turn OFF the power to each piece
of equipment before performing the following. Otherwise, an
electric shock may result.
1. Check the cables

a) Ensure that cables are not damaged and cable jackets are not torn.
b) Ensure that the power cord plugs are securely connected to both the
equipment AC inlet and the AC outlet.
2. Check the detector
a) Ensure that there are no loose screws or breaks.
b) Ensure that there is no dust or foreign matter on the battery bay
connector.
c) Ensure that there are no breaks or short-circuits in the battery bay
connector.
3. Start the NX workstation and perform a test exposure.
0351A EN 20190319 1349 *

Yearly inspection
To indicate when the yearly calibration is due, a message is displayed on the
NX workstation.
Perform calibration yearly or when exposure conditions have changed

significantly. For details, refer to the DX-D DR Detector Calibration Key
User Manual (0134).
0351A EN 20190319 1349 *

Regular Inspection and Maintenance

In order to ensure the safety of patients, operating personnel and third
parties, and to maintain the performance and reliability of the equipment, be
sure to perform regular inspection at least once a year. Clean up the
equipment, make adjustments, or replace consumables. There may be cases
where overhaul is recommended depending on the conditions. Contact your
sales representative or local dealer for regular inspections or maintenance.
CAUTION:
Clean the plug of the power cord periodically by unplugging it
from the AC outlet and removing dust or dirt from the plug, its
periphery and AC outlet with a dry cloth. If the cord is kept
plugged in for a long time in a dusty, humid or sooty place, dust
around the plug will attract moisture. This could cause
insulation failure resulting in a fire.
CAUTION:
Do not perform maintenance and inspection while the
equipment is used for a patient.
0351A EN 20190319 1349 *

Replacement Parts Support

Parts required to maintain the functioning of the product will be stocked for
seven years after discontinuance of production, to allow for repair.
0351A EN 20190319 1349 *

Repair
The product can only be repaired in the factory.
0351A EN 20190319 1349 *

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.
0351A EN 20190319 1349 *

Environmental Protection
Disposal of this product in an unlawful manner may have a negative impact on
health and on the environment. Therefore, when disposing of this product, be
absolutely sure to follow the procedure which is in conformity with the laws
and regulations applicable in your area.
Figure 13: WEEE end user information
The directive on Waste Electrical and Electronic Equipment (WEEE Directive

2012/19/EU) 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.
This 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 Agfa service organization and/or Agfa 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.
Figure 14: Battery Notice
This wheeled bin symbol on the products, and/or accompanying documents

means that the used batteries should not be treated as, or mixed with general
household waste.
This wheeled bin 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.
0351A EN 20190319 1349 *

Safety Directions
WARNING:
Safety is only guaranteed when an Agfa certified field service
engineer has installed the product.
WARNING:
Improper changes, additions, maintenance or repair of the
system 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 or store the equipment near flammable chemicals
such as alcohol, thinner, benzine, etc. If chemicals are spilled or
evaporate, it may result in fire or electric shock through contact
with electric parts inside the equipment. Also, some
disinfectants are flammable. Take care when using them.
WARNING:
Do not connect the equipment with anything other than
specified. Doing so may result in fire or electric shock.
WARNING:
Never disassemble or modify the equipment. Doing so may
result in fire or electric shock. Also, since the equipment
incorporates parts that may cause electric shock as well as other
hazardous parts, touching them may cause death or serious
injury.
WARNING:
Never remove or modify files on the workstation that are
associated to the equipment software. Only use the tools
provided with the product.
WARNING:
Do not place anything on top of the equipment. The object may
fall and cause an injury. Also, if metal objects such as needles,
staples or clips fall into the equipment, or if liquid is spilled, it
may result in fire or electric shock.
0351A EN 20190319 1349 *

WARNING:
Do not hit or drop the equipment. The equipment may be
damaged if it receives a strong jolt, which may result in fire or
electric shock if the equipment is used without being repaired.
WARNING:
Have the patient take a fixed posture and do not let the patient
touch parts unnecessarily. If the patient touches connectors or
switches, it may result in electric shock or malfunction of the
equipment.
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:
System unavailability due to hardware or software failure. If the
product is used in critical clinical workflows, a backup system
has to be foreseen.
CAUTION:
Strictly observe all warnings, cautions, notes and safety
markings within this document and on the product.
CAUTION:
All Agfa medical products must be used by trained and qualified
personnel.
CAUTION:
This device is not intended to supply heat to a patient. However,
during normal use, surfaces will become heated due to power
dissipation. Patient contact surfaces will not exceed 48 ºC under
normal useconditions. The operator should monitor and
evaluate how much of the patient’s body area is in contact with
these surfaces and for how long.
CAUTION:
Excessive ambient temperature may impact performance of DR
Detectors and cause permanent damage to the equipment. If
ambient temperature and humidity is outside the range of 15 -
35 °C and 20 - 80% RH, do not operate the system or use air
conditioning. Warranty will be void if it is obvious that
operating conditions are not met.
CAUTION:
Turn OFF the power to each piece of equipment for safety when
not being used.
0351A EN 20190319 1349 *

CAUTION:
Handle the equipment carefully. Do not submerge the
equipment in water. The internal image sensor may be damaged
if something hits against it, or if it is dropped, or receives a
strong jolt.
CAUTION:
Do not place excessive weight on the detector. Avoid the
whole weight of the patient body to rest on the detector.
Otherwise, the internal image sensor may be damaged.
Load limit - Uniform load: 150 kg over the whole area of the
detector surface. Load limit - Local load: 100 kg on an area
80 mm in diameter.
CAUTION:
Be sure to use the detector on a flat and rigid surface so it will
not bend. Otherwise, the internal image sensor may be
damaged. Be sure to securely hold the detector while using it in
upright positions. Otherwise, the detector may fall over,
resulting in injury to the user or patient, or may flip over,
resulting in damage to the inner device.
CAUTION:
If a malfunction occurs, do not use this device until qualified
personnel correct the problem.
Should any of the following occur, immediately turn OFF the
power to each piece of equipment, unplug the power cord from
the AC outlet, and contact your sales representative or local
dealer:
• When there is smoke, an odd smell or abnormal sound
• When liquid has been spilled into the equipment or a metal
object has entered through an opening
• When the equipment has been dropped and is damaged
CAUTION:
Observe great care when handling the DR Detector. The detector
is shock sensitive and drops should be avoided. The DR Detector
contains a shock sensor to detect if the detector is dropped from
a height of more than 70 cm. Warranty will be void if it is
obvious that operating conditions are not met.
0351A EN 20190319 1349 *

If the DR Detector has been dropped:

1. Visually check the DR Detector for deformations.
2. Perform a calibration of the DR Detector. For instructions, refer
to the DX-D DR Detector Calibration Key User Manual
(document 0134).
3. Perform a flat field exposure and check the image for visible
artifacts. Typical flat field exposure settings are 75 kV, 10 µGy,
large focus and using 1.5 mm Cu filter without grid.
CAUTION:
Damaged grid. Reduced image quality. Please handle the grids
with special care.
Topics:
• DR Detector Battery
• Safety directions for the power supply
0351A EN 20190319 1349 *

DR Detector Battery
Safety Directions
WARNING:
Do not use any charger other than that specifically provided
for use with the equipment.
The battery is used with the DR Detector. Do not use them in
other combinations.
Use only a power adapter complying with IEC 60601-1 or IEC
60950-1.
Make sure to turn off the detector before detaching a battery
pack.
When the detector is not to be used for some time, remove the
battery pack. Otherwise, over discharge may occur resulting in
the shortened battery life.
Securely plug the power cord of the charger into the AC outlet. If
contact failure occurs, or if dust/metal objects come into contact
with the exposed metal prongs of the plug, fire or electric shock
may result.
Stop charging the battery when the battery charger indicator
lights keep indicating that the battery is charging, beyond the
specified charging time. Not doing so may result in the battery
overheating or smoking or in an explosion or fire.
Always check the remaining amount of the battery pack during
use of the detector. If performance of the battery pack has some
problems, consult your local Agfa representative.
The battery charger is designed for the dedicated battery pack.
Do not use the battery charger other than the dedicated one.
Otherwise, a battery explosion or a battery leak may occur,
resulting in fire or electrical shock.
Do not operate the battery charger using any type of power
supply other than the one indicated on the rating label.
Do not handle the product with wet hands.
Do not attempt to disassemble, alter, or apply heat to the
product.
Avoid dropping or subjecting the product to severe impacts. To
avoid the risk of injury, do not touch the internal parts of the
battery if it has been cracked or otherwise damaged.
Stop using the battery pack immediately if it emits smoke, a
strange smell, or otherwise behaves abnormally.
0351A EN 20190319 1349 *

Do not let the battery pack and battery charger come into
contact with water or other liquids and do not allow them to get
wet.
Do not clean with substances containing organic solvents such
as alcohol, benzene, thinner, or other chemicals. Otherwise, fire
or electrical shock may result.
Do not allow dirt or metal objects (such as hair pins, clips,
staples or keys) to contact the terminals. Otherwise, battery
explosion or leakage of electrolyte may occur, resulting in fire,
injury or pollution of surrounding area. If the battery leaks and
the electrolytes come into contact with your eyes, mouth, skin or
clothing, immediately wash it away with running water and
seek medical attention.
Do not leave, store, or place the product in a location near heat
sources, or in a place subject to direct sunlight, high
temperature, high humidity, excessive dust, or mechanical
shock. Otherwise, battery leakage, overheating or damage to
the product may occur, resulting in electrical shock, burns,
injury or fire.
If the battery pack becomes heated or swollen, immediately
replace the battery with a new one before using it. Otherwise,
overheat, smoke, explosion, or fire may occur.
The Lithium ion/polymer battery is recyclable.
Battery slowly discharges even if not in use. The battery pack
may have expired if it discharges immediately after being fully
charged. You can purchase an optional battery pack to replace
an exhausted one. The battery pack is a consumable item. If a
fully charged battery is consumed quickly, use a new and fully
charged battery pack.
Be sure to charge the battery periodically (once a year) if it is
not used for an extended period of time. The battery pack
cannot be charged if it has been over discharged.
Before discarding the battery pack, cover the terminals with
adhesive tape or other insulators. Contact with other metal
materials may cause fire or explosion.
0351A EN 20190319 1349 *

Safety directions for the power supply

WARNING:
Do not operate the equipment using any type of power supply
other than the one indicated on the rating label. Otherwise, it
may result in fire or electric shock.
WARNING:
Do not use any power cords other than the one provided with
this equipment. Otherwise, it may result in fire or electric shock.
WARNING:
Do not handle the equipment with wet hands. You may
experience an electric shock that could result in death or serious
injury.
WARNING:
Do not place heavy objects such as medical equipment on cables
and cords, or do not pull, bend, bundle or step on them to
prevent their sheath from being damaged, and do not alter them
neither. Doing so may result in fire or electric shock.
WARNING:
Do not supply power to more than one piece of equipment using
the same AC outlet. Doing so may result in fire or electric shock.
WARNING:
Do not connect a multiple portable socket-outlet or extension
cord to the system. Doing so may result in a fire or electric
shock.
WARNING:
Securely plug the power cord into the AC outlet. If contact
failure occurs, or if dust or metal objects come into contact with
the exposed metal prongs of the plug, fire or electric shock may
result.
WARNING:
Be sure to turn off the power to each piece of equipment before
connecting or disconnecting the cords. Otherwise, you may get
an electric shock that could result in death or serious injury.
WARNING:
Do not connect the AC or DC power cable to the product with
the power applied. Failure to do so may result in damage to the
product.
0351A EN 20190319 1349 *

WARNING:
Be sure to hold the plug or connector to unplug the power cord.
If you pull the power cord, the core wire may be damaged,
resulting in fire or electric shock.
WARNING:
When using the power supply, care must be taken to ensure that
there is either a mains plug or an all-cable disconnecting device
in the internal installation fitted near the device and that it is
easily accessible in case of emergency.
0351A EN 20190319 1349 *

66 | DR 10s | Getting started
Getting started
Topics:
• Starting the DR Detector

• Basic Workflow DR Detector
• Guidelines for Pediatric Applications
• Stopping the DR Detector
• Automatic exposure detection
0351A EN 20190319 1349 *

DR 10s | Getting started | 67
Starting the DR Detector

CAUTION:
Do not use the battery pack as a power source for equipment
other than DR 10s or DR 14s detectors. Be sure to use only the
dedicated battery pack for the DR 10s or DR 14s detector.
Note: Before operating the detector, start up the NX workstation.
For using the fixed DR Detector, the temperature difference between

calibration and usage must be within the recommended range of +/-6°C (for
a DR Detector with CsI conversion screen) or +/-10°C (for a DR Detector with
GOS conversion screen). Check the environmental conditions and observe the
warming-up time of the DR Detector.
To start the DR Detector:
1. Fully charge the battery.

Charge the battery on the day of examination or on the previous day.
Note: The battery slowly discharges even if not in use. The
battery pack may have expired if it discharges immediately
after being fully charged. You can purchase an optional battery
pack to replace an exhausted one.
2. Attach the battery.

Note: Make sure that the lock lever is placed to the (unlock)
side.
Align the claw on the battery pack and the groove on the battery bay (1).
Insert the battery pack fully (2). Push down the battery pack (3). Turn the
latch clockwise (4) and lock it.
1 1
2
4
3
Figure 15: Attach the battery
0351A EN 20190319 1349 *

Note: Make sure that the battery is securely attached.
The detector starts up.

3. If the detector was turned off without removing the battery, use the power
button to turn on the detector.
Press and hold the power button for 1 second.
Figure 16: Power button
During startup the status indicator is flashing orange. After startup the
status indicator is lit green, indicating the power status.
4. Check the DR Detector status icon on the DR Detector Switch. If the
displayed status is error and the detector is shared between NX
workstations, it may still be connected to another NX workstation. Hold
the detector with its IR data port close to the IR Data Communication Unit
that is connected to the NX workstation.
All status indicators on the DR Detector are lit green. The DR Detector is
ready.
Before exposure make sure to check the equipment daily and confirm that it
works properly.
Related Links
DR 10s on page 18
Registering the DR Detector to an NX Workstation using automatic registration
on page 90
0351A EN 20190319 1349 *

Basic Workflow DR Detector

Topics:
• Step 1: retrieve the patient info

• Step 2: select the exposure
• Step 3: prepare the exposure
• Step 4: check the exposure settings
• Step 5: execute the exposure
• Positioning the DR Detector
0351A EN 20190319 1349 *

Step 1: retrieve the patient info

At the NX workstation:
1. When a new patient comes in, define the patient info for the exam.
2. Start the exam.
Step 2: select the exposure

1. At the NX workstation, select the thumbnail for the exposure in the Image
Overview pane of the Examination window.
The selected DR Detector is activated.
The DR Detector Switch shows the active DR Detector and shows its status.
• Red (flashing): starting up
• Green (constant): ready for exposure
2. At the X-ray generator console, select the exposure settings suitable for the
exposure.
0351A EN 20190319 1349 *

Step 3: prepare the exposure

In the examination room:
1. Position the DR Detector.

When using the bucky, check that the identification labels on the DR
Detector and on the bucky match. Do not use a DR Detector that is
dedicated to another bucky.
2. Position the patient.
Apply radiation protective measures for the patient if needed.
3. Check if the X-Ray system position is suitable for the exposure.
4. Position the X-Ray tube with respect to the DR Detector and the patient.
5. Set the correct distance between DR Detector and X-Ray tube.
6. Switch on the light on the collimator. Adapt collimation if required.
Take care that the collimated area is not larger than the detector.
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.
0351A EN 20190319 1349 *

Step 4: check the exposure settings
On the DR Detector Switch:
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.
3. Check the DR Detector Status icon.
On the X-ray system:
1. Check if the exposure settings displayed on the console are suitable for the
exposure.
2. Check if no error messages are displayed on the X-ray system.
Exposure synchronization
Depending on the configuration, the DR Detector synchronizes to the
exposure using one of these methods:
• X-ray generator synchronization
• Automatic exposure detection
WARNING:
In a configuration using automatic exposure detection, the X-ray
system allows executing an exposure, even if the DR Detector is
not ready. Avoid unnecessary dose by checking the status of the
DR Detector before exposure. The DR Detector Switch displays
the DR Detector status icon.
Related Links
DR Detector Switch on the NX Workstation on page 20
Automatic exposure detection on page 80
0351A EN 20190319 1349 *

Step 5: execute the exposure

Press the exposure button to execute the exposure.
Make sure the generator is ready for exposure before you
press the exposure button.
WARNING:
The radiation indicator on the control console lights up
during exposure release.
WARNING:
Do not select another thumbnail until the preview image is
visible in the active thumbnail.
At the NX workstation:
• The image is acquired from the DR detector and displayed in the
thumbnail.
• If collimation is applied, the image is automatically cropped at the
collimation borders.
0351A EN 20190319 1349 *

Positioning the DR Detector

When performing an exposure, keep in mind the following detector
orientation aids:
• tube side
• patient orientation marker
Figure 17: Detector orientation aids
1. Location blue patient orientation marker

2. Tube side of the detector
The detector orientation and the patient orientation are exposure settings on
the NX workstation. The detector orientation is displayed on the NX
workstation as cassette orientation.
The user is responsible for the correct and clear marking on the left or right
side of the image to eliminate possible errors.
Table 2: Table with bucky
Table with bucky, portrait
Table with bucky, landscape
Note: NX is configured for a specific patient orientation, either

head left (default) or head right.
0351A EN 20190319 1349 *

Table 3: Wallstand bucky
Wallstand with left loading bucky, landscape
Wallstand with right loading bucky, landscape
0351A EN 20190319 1349 *

Guidelines for Pediatric Applications

CAUTION:
Children are more radiosensitive than adults. Adopting the
Image Gently campaign guidelines and reducing dose for
radiographic procedures while maintaining acceptable clinical
image quality will benefit patients.
Please review the following link and reduce pediatric technique factors
accordingly: http://www.imagegently.org
As a general rule, next recommendations shall be observed in pediatrics:
• X-Ray Generator must have short exposures times.
• ΑΕC must be used carefully, preferably use manual technique setting,
applying lower doses.
• If possible, use high kVp techniques.
Positioning the pediatric patient: Pediatric patients are not as likely as adults
to understand the need to remain still during the procedure. Therefore it
makes sense to provide aids to maintaining stable positioning. It is strongly
recommended the use of immobilizing devices such as bean bags and restraint
systems (foam wedges, adhesive tapes, etc.) to avoid the need of repeating
exposures due to the movement of the pediatric patients. Whenever possible
use techniques based on the lowest exposure times.
Shielding: We recommend you provide extra shielding of radiosensitive
organs or tissues such as eyes, gonads and thyroid glands. Applying a correct
collimation will help to protect the patient against excessive radiation as well.
Please review the following scientific literature regarding pediatric
radiosensitivity: GROSSMAN, Herman. “Radiation Protection in Diagnostic
Radiography of Children”. Pediatric Radiology, Vol. 51, (No. 1): 141--144,
January, 1973:
http://pediatrics.aappublications.org/cgi/reprint/51/1/141.
Technique factors: You should take steps to reduce technique factors to the
lowest possible levels consistent with good image acquisition.
For example if your adult abdomen settings are: 70--85 kVp, 200--400 mA,
15--80 mAs, consider starting at 65--75 kVp, 100--160 mA, 2.5--10 mAs for a
pediatric patient. Whenever possible use high kVp techniques and large SID
(Source Image Distance).
Summary:
• Image only when there is a clear medical benefit.
• Image only the indicated area.
• Use the lowest amount of radiation for adequate imaging based on size of
the child (reducing tube output -- kVp and mAs).
• Try to use always short exposure times, large SID values and immobilizing
devices.
0351A EN 20190319 1349 *

• Avoid multiple scans and use alternative diagnostic studies (such as

ultrasound or MRI) when possible.
0351A EN 20190319 1349 *

Stopping the DR Detector

To stop the DR Detector:
1. Turn off the detector.

Press and hold the power button until the orange status indicator starts
flashing (approx. 5 seconds).
During shutdown, the orange status indicator is flashing. After shutdown,
all the status indicator lights are off.
2. Turn the latch counterclockwise (unlock) (1) and lift the battery up (2),
and then remove the battery.
2 1
Figure 18: Remove the battery
Note: When the detector will not be used for some time, remove
the battery. Otherwise, overdischarge may occur, leading to a
shorter battery life.
Note: When not in use, keep the detector, handle unit with grid
in a designated location or in a location where they are safe
and cannot fall down.
Related Links
Storing a battery on page 88
Topics:
• Automatically turning the DR Detector to sleep

• Automatically turning off DR Detector
0351A EN 20190319 1349 *

Automatically turning the DR Detector to sleep

The DR Detector can be configured to switch to standby (sleep) automatically
after not being used for a specific time.
New exposures can be made. After selecting an exposure on the NX
workstation, there will be a short delay until the DR Detector becomes ready
for exposure.
Automatically turning off DR Detector

The DR Detector can be configured to switch off automatically after not being
used for a specific time.
For making new exposures, the DR Detector must be started again using the
power button.
0351A EN 20190319 1349 *

Automatic exposure detection

The DR detector detects X-ray exposure to automatically perform the image
acquisition.
Before performing the exposure, the DR detector must be ready. Check the
status of the DR detector in the DR Detector Switch.
WARNING:
Do not hit or drop the equipment. If it receives a strong jolt,
image acquisition can be triggered without X-ray exposure.
WARNING:
Very short exposure time can cause failure to trigger the image
acquisition. Use an exposure time of at least 5 ms.
WARNING:
Applying collimation to leave only a very small area exposed can
cause failure to trigger the image acquisition.
WARNING:
Very low dose can cause failure to trigger the image acquisition.
A dose of at least 5 nGy is required.
WARNING:
Specific exposure conditions (use of grid, thickness of the
exposed object) can cause failure to trigger the image
acquisition or horizontal artifacts in the acquired image.
Related Links
Positioning the DR Detector on page 74
0351A EN 20190319 1349 *

DR 10s | Advanced Operating | 81
Advanced Operating
Topics:
• Detector Status Indicators

• Charging a battery
• First use of a new battery
• Storing a battery
• Sharing the DR Detector between NX Workstations
0351A EN 20190319 1349 *

82 | DR 10s | Advanced Operating
Detector Status Indicators

Table 4: DR Detector status
Indicator Light Status

OFF Power OFF
Orange During startup or

shutdown or to
Blinking indicate an error
Green Ready status
Not ready for ex-

Status indicator posure or during
Orange
image transmis-
sion
Green
Sleep mode
Blinking
During startup or
OFF when no battery
is inserted
Orange Battery charge

Blinking fast level below 5%
Battery charge
Battery indicator Orange level between 5%
and 10%
Battery charge
Green level between
10% and 100%
OFF During startup
Green Connected to
wireless access
point
Wifi indicator Orange Not connected to

wireless access
point
Related Links
0351A EN 20190319 1349 *

Charging a battery
To charge a battery using the battery charger:
1. Connect the power supply to the mains power and to the power socket of
the battery charger.
2. Insert the battery in an empty slot of the battery charger.
The battery charger automatically detects the battery and starts charging
the battery.
The battery status can be read from the indicator lights.
The charge level of the battery is monitored and it is kept at maximum
level until the battery is removed from the battery charger.
3. Remove the charged battery from the battery charger.
Related Links
Safety Directions on page 62
DR Detector Battery Charger on page 19
Topics:
• Inserting the battery in the battery charger

• Battery charger indicator lights
0351A EN 20190319 1349 *

Inserting the battery in the battery charger
Insert the battery aligning the position indicators.
Figure 19: Inserting the battery in the battery charger
0351A EN 20190319 1349 *

Battery charger indicator lights

The battery charger has three slots to insert a battery.
Each slot has a battery status display with indicator lights to inform the user
about the status of the inserted battery.
Table 5: Battery status display
Label Light Status
Green blink- The battery is being charged.

ing
Battery charge level 0-25%.
The battery is being charged.



Green Battery charging is completed. Charge is sufficient to

perform examinations.
In order to optimize battery lifetime, it is recommen-
ded not to leave the battery permanently powered by
the charger.
Orange Error.
Battery charging not possible.
WARNING:
The lifetime and full charge level of the battery can degrade if
the battery is removed before the battery charging is completed
and if the charge is performed at low temperature (less than
20 °C).
The green indicator light at the back of the battery charger indicates that the
battery charger is connected to the power supply.
0351A EN 20190319 1349 *

1 2
1. Green indicator light

2. Connector
Figure 20: Back of the battery charger
0351A EN 20190319 1349 *

First use of a new battery

A new battery may need activation before using it in the DR Detector.
1. Insert the battery in the battery charger.

The battery charger indicator lights light up.
2. Remove the battery from the battery charger.
The battery is activated and can be used in the DR Detector.
0351A EN 20190319 1349 *

Storing a battery
Prolonged storage of a fully discharged or fully charged battery can damage
the battery. Storage of a battery at elevated temperature can damage the
battery. Batteries should be stored in a partially charged state, at storage
temperature.
A new battery contains sufficient charge and requires no maintenance if used
within one year of manufacture.
Following use in the device, if a used battery must be stored for more than one
month, follow this procedure to store the battery on the appropriate charge
level:
To store a battery:
1. Put the battery in normal use until the battery charge level is below the
storage charge level.
New batteries already have a battery charge level lower than the storage
charge level.
2. Start charging the battery.
3. Monitor the battery status and stop charging the battery when the charge
level has reached the storage charge level.
4. Store the battery at storage temperature in an environment with low
humidity and free from corrosive gas.
5. Repeat previous steps if storage is more than 6 months.
After an extended period of storage, it may be necessary to charge and

discharge the battery several times to obtain the maximum performance.
Storage conditions
Storage charge level 50%
Storage temperature at or below room temperature (+20°C)
0351A EN 20190319 1349 *

Sharing the DR Detector between NX Workstations

To share a DR Detector between NX Workstations, the DR Detector must be
configured on each of the workstations. An IR Data Communication Unit is
connected to each of the workstations.
Note: The IR Data Communication Unit is configured to be
connected to a specific USB port. Do not connect it to another USB
port.
The DR Detector is set up to communicate to a specific NX workstation. The

procedure of registering the DR Detector to another NX workstation switches
the availability of the DR Detector between NX workstations.
There are two workflows for registering the DR Detector. Which workflow is
used, is configured on the NX workstation during installation.
• Using automatic registration.
The registration is initiated by holding the detector with its IR data port
close to the IR Data Communication Unit that is connected to the NX
workstation.
• Using the DR 10s DR 14s Registration Tool
The registration is initiated by running the tool on the NX workstation.
Topics:
• Registering the DR Detector to an NX Workstation using automatic

registration
• Registering the DR Detector to an NX Workstation using the DR 10s DR
14s Registration Tool
0351A EN 20190319 1349 *

Registering the DR Detector to an NX Workstation using

automatic registration
1. Start the NX workstation.
2. Turn on the detector.
3. Hold the detector with its IR data port close to the IR Data Communication
Unit that is connected to the NX workstation.
A dialog is displayed on the NX workstation indicating that the network
settings of the DR Detector are being updated.
Note: Do not cover the IR data port of the DR Detector with
your hands. Otherwise, the properties of wireless
communication, such as the throughput and operable distance,
may decrease.
Note: Other detectors in the direct vicinity may interfere

with the communication to the NX workstation. Make sure
they are out of reach of the IR Data Communication Unit.
After a short time another dialog is displayed indicating that sharing the
DR Detector has been successful. It may take up to 30 seconds for the
dialog to pop up.
The DR Detector is restarting.
4. Remove the detector from the IR Data Communication Unit and click OK.
5. In specific configurations, the DR Detector turns to error status directly
after registration to another NX workstation, or after attempting a first
exposure. In this case, stop and restart the DR Detector using the power
button, each time after it has been registered to another NX workstation.
For more information, contact your local service representative.
The DR Detector is set up to make connection to the selected NX workstation.

The DR Detector connection status icon in the DR Detector Switch is
displayed.
Related Links
Stopping the DR Detector on page 78
Starting the DR Detector on page 67
0351A EN 20190319 1349 *

Registering the DR Detector to an NX Workstation using the

DR 10s DR 14s Registration Tool
1. Start the NX workstation.
2. Turn on the detector.
3. On the NX workstation, go to the Main Menu
4. Click the Show Desktop action button.
The Windows desktop is shown.
5. Click the DR 10s DR 14s Registration Tool icon on the desktop.
A dialog is displayed instructing to remove all DR Detectors away from the

IR Data Communication Unit.
Note: Other detectors in the direct vicinity may interfere
with the communication to the NX workstation. Make sure
they are out of reach of the IR Data Communication Unit.
6. Click OK.
A dialog is displayed instructing to hold the detector with its IR data port
close to the IR Data Communication Unit.
7. Hold the detector with its IR data port close to the IR Data Communication
Unit that is connected to the NX workstation.
A dialog is displayed on the NX workstation indicating that the network
settings of the DR Detector are being updated.
Note: Do not cover the IR data port of the DR Detector with
your hands. Otherwise, the properties of wireless
communication, such as the throughput and operable distance,
may decrease.
After a short time another dialog is displayed indicating that sharing the
DR Detector has been successful. It may take up to 30 seconds for the
dialog to pop up.
The DR Detector is restarting.
8. Remove the detector from the IR Data Communication Unit and click OK.
9. In specific configurations, the DR Detector turns to error status directly
after registration to another NX workstation, or after attempting a first
0351A EN 20190319 1349 *

exposure. In this case, stop and restart the DR Detector using the power
button, each time after it has been registered to another NX workstation.
For more information, contact your local service representative.
10. Go back to NX by clicking NX in the Windows task bar.
The DR Detector is set up to make connection to the selected NX workstation.

The DR Detector connection status icon in the DR Detector Switch is
displayed.
0351A EN 20190319 1349 *

DR 10s | Problem solving | 93
Problem solving
Topics:
• Artifact in DR Detector images

• Identifying problems
0351A EN 20190319 1349 *

94 | DR 10s | Problem solving
Artifact in DR Detector images

Details An artifact is visible in the images produced by a DR
Detector.
Cause Exposure conditions have changed significantly since

latest calibration.
Brief Solution Perform calibration of the DR Detector.

For details, refer to the DX-D DR Detector Calibration
Key User Manual (0134).
0351A EN 20190319 1349 *

DR 10s | Problem solving | 95
Identifying problems
Please refer to the details of following symptoms or error messages. If the
problem persists, turn off the detector and consult your sales representative or
local dealer.
WARNING:
Improper changes, additions, maintenance or repair of the
system 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.
Symptom Cause Remedy
The detector will not The battery is not at- Attach the battery.
turn on. tached.
The battery pack is Fully charge the battery pack.

not charged.
The battery pack is Replace the battery pack.

broken.
A fully charged bat- The battery capacity The DR Detector battery can
tery is consumed decreases. deteriorate because of its char-
quickly. acteristics and structure. For
purchase of consumables, con-
tact your sales representative
or local dealer.
The battery was In low temperatures the bat-

charged or used in tery capacity decreases. Use a
low temperatures. battery charged in normal
temperatures.
The battery bay is The battery is mal- Stop using the battery and
unusually hot. functioning. consult your sales representa-
tive or local dealer.
Sharing the DR De- The DR Detector is Contact your local service rep-
tector between NX not configured on resentative.
Workstations fails the NX workstation.
0351A EN 20190319 1349 *

96 | DR 10s | Problem solving
Symptom Cause Remedy

The IR Data Commu- Reconnect the IR Data Com-
nication Unit is con- munication Unit to the USB
nected to the wrong port where it was connected
USB port. during setup.
Battery thermal protection

The battery pack has a thermal protection that shuts down the battery power
in case of very high temperature.
Two situations can occur:
• Software protection: the battery pack will be usable as soon as the
temperature drops below a specified limit.
• Hardware protection: the battery pack must be exchanged.
0351A EN 20190319 1349 *

DR 10s | Technical Data | 97
Technical Data
Topics:
• DR 10s
• DR 10s, DR 14s Battery
• DR 10s, DR 14s Battery Charger
0351A EN 20190319 1349 *

98 | DR 10s | Technical Data
DR 10s
Commercial name DR 10s
Manufacturer
Manufacturer DR Detector THALES AVS FRANCE SAS

460 rue du Pommarin
38430 MOIRANS FRANCE
Distributor DR Detector Agfa NV
Septestraat 27,
B-2640 Mortsel - Belgium
Original manufacturer model name
DR 10s Pixium 2430 EZ-C
Electrical connection DR Detector
Rated power supply +12V 1A DC

(powered by battery pack)
Wireless connection IEEE 802.11a/b/g/n (2.4 GHz/5 GHz)

Wireless signal range (in an open maximum 6 m
space)
Environmental conditions (during normal operation)
Room temperature between +15 °C and +35 °C
Humidity (non condensing) between 20% and 80% RH

(non-condensing)
Atmospheric pressure between 700 hPa and 1100 hPa
Environmental conditions (during storage)
Temperature (ambient) between -10 °C and +55 °C
Humidity (non condensing) between 5% and 95%

(non-condensing)
Atmospheric pressure between 500 and 1100 hPa
Warming-up time
0351A EN 20190319 1349 *

30 minutes
Dimensions
Dimensions approx. 268.5 x 328.5 x 16.0 mm

width x length x height
Weight (incl. battery) 1.6 kg
Maximum total load 135 kg over the whole detector surface

150 kg over the whole detector surface
(image quality of the exposure may not
be optimal)
Maximum load 80 kg on an area of 80 mm in diameter

100 kg on an area of 80 mm in diameter
(image quality of the exposure may not
be optimal)
Vibration tolerance 2g
Shock tolerance 10 g
SAR value 0.276 W/kg
Throughput (images per hour) 240
Conversion screen CsI
Pixel size 148 µm
Active pixel matrix 1560 x 1920
Effective pixel matrix 1500 x 1920
Detector type amorphous silicium
Active area size 230.9 mm x 284.2 mm
Effective area size 222.0 mm x 284.2 mm
X-ray performance
Performance Typical Minimum
MTF horizontal 61 55
1 lp/mm
MTF vertical 61 55
0351A EN 20190319 1349 *

Performance Typical Minimum
1 lp/mm
2 lp/mm
MTF vertical 30 25
2 lp/mm
3 lp/mm
MTF vertical 14 10
3 lp/mm
MTF horizontal 12 7
Nyquist frequency
MTF vertical 10 7
Nyquist frequency
DQE 66 56
0.05 lp/mm, 2μGy
DQE 50 42
1 lp/mm, 2μGy
DQE 40 33
2 lp/mm, 2μGy
DQE 24 19
3 lp/mm, 2μGy
DQE 17 12
Nyquist frequency, 2μGy
0351A EN 20190319 1349 *

DR 10s, DR 14s Battery

Type of product Rechargeable lithium ion battery pack
Model BATTERY EZ
Dimensions
Dimensions (length x width x 250 mm x 75 mm x 6 mm
height)
Weight 228 g
Battery output
Output voltage DC +7.4 V
Capacity 3.68 Ah
Lifecycle
Preventive maintenance frequency. No preventive maintenance required.

Estimated product life Estimated product life: 1 year
0351A EN 20190319 1349 *

DR 10s, DR 14s Battery Charger

Type of product Lithium ion battery pack charger
Model CHARGER 2EZ
Charging time 4 hours
Simultaneous charging 3 batteries
Dimensions
Dimensions (width x height x depth) 320 mm x 50 mm x 170 mm
Weight 1065 g
Electrical connection
Rated Power Supply 12 Vdc, 5 A Max
Lifecycle
Preventive maintenance frequency. No preventive maintenance required.
0351A EN 20190319 1349 *

DR 10s | Remarks for HF-emission and immunity | 103
Remarks for HF-emission and immunity

Topics:
• EMC (Electromagnetic Compatibility) Statements

• Precautions on EMC
• Electromagnetic emissions
• Electromagnetic immunity
• Recommended separation distance
• For U.S.A.
0351A EN 20190319 1349 *

104 | DR 10s | Remarks for HF-emission and immunity
EMC (Electromagnetic Compatibility) Statements

The DR Detector is designed and tested to comply with IEC
60601-1-2(EN60601-1-2) which is applicable to regulations regarding EMC
for medical devices and needs to be installed and put into service according to
the EMC information stated as follows.
If this equipment does cause harmful interference to other devices, which can
be determined by turning the equipment off and on, the user is encouraged to
try to correct the interference by one or more of the following measures:
• reorient or relocate the receiving device.
• increase the separation between the devices.
• connect the equipment into an outlet on a circuit different from that to
which the other devices are connected.
If the problem cannot be solved with the above measures, stop using the
equipment and consult your sales representative or local Agfa dealer.
0351A EN 20190319 1349 *

Precautions on EMC
Medical electrical equipment needs special precautions regarding EMC and
needs to be installed and put into service according to the EMC information
provided in the manual.
Portable and mobile RF communications equipment can affect medical
electrical equipment.
WARNING:
The DR Detector should not be used adjacent to or stacked with
other equipment and if adjacent or stacked use is necessary, the
DR Detector should be observed to verify normal operation in
the configuration in which it will be used.
WARNING:
Avoid to place the DR Detector too close to life supporting
devices. Keep a minimal distance of 26 cm between the DR
Detector and life supporting devices.
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.
0351A EN 20190319 1349 *

Electromagnetic emissions
This DR Detector has been tested for a normal hospital environment as
described below.
The user of the DR Detector should ensure that it is used in such an
environment.
Nevertheless the HF-emission and immunity can be influenced by connected
data cables depending on length and the manner of installation.
Emissions test Compliance Electromagnetic Environment

Guidelines
RF emissions in accord- Group 1 This DR Detector uses RF energy

ance with CISPR 11 for data transmission. Therefore,
its RF emissions can cause inter-
ferences in nearby electronic
equipment.
RF emissions in accord- Class B The DR Detector is suitable for

ance with CISPR 11 use in all establishments, includ-
ing domestic establishments and
Harmonic emissions in ac- Complies those directly connected to the
cordance with IEC public low-voltage power supply
Class B
61000-3-2 network that supplies buildings
used for domestic purposes.
Voltage fluctuations / Complies
flicker emissions in ac-
cordance with
IEC 61000-3-3
0351A EN 20190319 1349 *

Electromagnetic immunity
This DR Detector is intended for operation in the electromagnetic
environment given below. The user of the DR Detector should ensure that it is
used in such an environment.
Resistance to IEC 60601 Level of Electromagnetic Envi-

Jamming Test Test Level Agreement ronment Guidelines
Discharge of ± 6 kV contact ± 6 contact Floors should consist of

static electrici- discharge discharge wood, concrete or ce-
ty in accord- ramic tiles. The relative
± 8 kV air dis- ± 8 kV air dis-
ance with humidity must be at least
charge charge
IEC 61000-4-2 30%, if the floor is made
of synthetic material.
Fast transient ± 2 kV for net- ± 2 kV for net- The quality of the volt-
electrical dis- work leads work leads age supplied should cor-
turbance vari- respond to a typical com-
± 1 kV for en- not applicable
ables / bursts mercial or clinical envi-
try and outlet
in accordance ronment.
leads
with IEC
61000-4-4
Impulse vol- ± 1 kV push- ± 1 kV push- The quality of the volt-

tages (surges) pull voltage pull voltage age supplied should cor-
in accordance respond to that of a typi-
± 2 kV com- ± 2 kV com-
with IEC cal commercial or clini-
mon mode mon mode
61000-4-5 cal environment.
voltage voltage
Voltage break- < 5% Ur not applicable The quality of the volt-

throughs, (> 95% break- age supply should corre-
short term in- through of Ur) spond to that of a typical
terruptions for ½ period commercial or clinical
and variations environment. If the user
40% Ur (>
in the voltage wants the DR Detector to
60% break-
supplied in ac- work continuously, even
through of Ur)
cordance with when the energy supply
for 5 periods
IEC is interrupted, it is rec-
61000-4-11 70% Ur (30% ommended to use an en-
breakthrough ergy supply free of inter-
of Ur) for 25 ruptions or a battery.
periods
< 5% Ur (95%
breakthrough
of Ur) for 5 s
0351A EN 20190319 1349 *

Magnetic field 3 A/m 3 A/m Magnetic field at the net-

at the supply work frequency should
frequency correspond to the typical
(50/60 Hz) in values as they are in a
accordance commercial and clinical
with IEC environment.
61000-4-8
GSM modula- 3 V/m 3 V/m Interference may occur

tion in the vicinity of equip-
900 MHz 900 MHz
ment marked with the
ENV 50204 modulated @ modulated @
following symbol:
200 Hz (square 200 Hz (square
signal) signal)
Radiated RF 3 V/m 3 V/m Interference may occur

in the vicinity of equip-
IEC 61000-4-3 80 MHz to 2.5 80 MHz to 2.5
ment marked with the
GHz GHz
following symbol:
80 MHz to 1 80 MHz to 1
GHz GHz
Note: Ur is the alternating voltage.
Tests of Resist- IEC 60601 Level of Electromagnetic Environment

ance to Disrup- Test Level Agree-
tion ment
Use portable and mobile radio

sets at a safe distance from the
DR Detector (including the
leads) not closer than the rec-
ommended protective distance,
which is calculated according to
the equation suitable for the
transmission frequency.
0351A EN 20190319 1349 *

Recommended protective dis-

tance:
Conducted high 3 Veff 3 Veff

frequency dis- d = 1.2
150 kHz 150 kHz
turbance varia-
to 80 MHz to 80
bles in accord-
MHz
ance with
IEC 61000-4-6
Radiated high 3 V/m 3 V/m

frequency dis- d = 1.2 80 MHz to 800
80 MHz to MHz
turbance varia-
2.5 GHz
bles in accord-
ance with
IEC 61000-4-3
d = 2.3 800 MHz to 2.5

GHz
With P as the rated power of the

transmitter in watts (W) in ac-
cordance with the manufacturer
information on the transmitter
and d as the recommended pro-
tective distance in metres (m).
The field strength of stationary
radio transmitters is lower than
the level of the agreement at all
frequencies in accordance with
an on-site investigation.
Disruptions are possible near
devices that carry the following
symbol:
Note: The higher value will apply at 80 MHz and 800 MHz.
0351A EN 20190319 1349 *

Note: These Guidelines may not apply to all situations. The dis-
persion of electromagnetic waves is influenced by absorption
and reflections from buildings, objects and people.
Note: The field strength of stationary transmitters, such as

base stations of radio telephones, mobile broadcasts for rural
areas, amateur stations, and AM and FM radio transmitters,
cannot be precisely predetermined theoretically. An investi-
gation of the location is recommended, to ascertain the elec-
tromagnetic environment as a result of stationary high fre-
quency transmitters. If the field strength of the device ex-
ceeds the level of agreement 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-orien-
tation of the device, for example.
Note: The field strength will be lower than 3 V/m above the
frequency range from 150 kHz to 80 MHz.
0351A EN 20190319 1349 *

Recommended separation distance

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.
Recommended Protective Distances between Portable and Mobile High Fre-

quency Communication Equipment and the Device
Rated Power of Protective Distance in accordance with Transmission

the Transmitter Frequency
W m
150 kHz to 80 80 MHz to 800 800 MHz to 2.5

MHz MHz GHz
d = 1.2 d = 1.2 d = 2.3
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the rec-
ommended separation distance d in meters (m) can be estimated using the
equation applicable to the frequency of the transmitter, where P is the maxi-
mum output power rating of the transmitter in watts (W) according to the
transmitter manufacturer.
REMARK 1: At 80 MHz and 800 MHz, the separation distance for the higher
frequency range applies.
REMARK 2: 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.
0351A EN 20190319 1349 *

For U.S.A.
This device complies with Part 15 of the FCC Rules.
Operation is subject to the following two conditions:
• This device may not cause harmful interference.
• This device must accept any interference received, including interference
that may cause undesired operation.
This equipment has been tested and found to comply with the limits for a
Class B 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 residential 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.
However, there is no guarantee that interference will not occur in a particular
installation. If this equipment does cause harmful interference to radio or
television reception, which can be determined by turning the equipment off
and on, the user is encouraged to try to correct the interference by one or
more of the following measure.
• Reorient or relocate the receiving antenna.
• Increase the separation between the equipment and receiver.
• Connect the equipment into an outlet on a circuit different from where the
receiver is connected.
• Consult the distributor or an experienced radio/TV technician for help.
FCC WARNING:
Changes or modifications not expressly approved by the party responsible for
compliance could void the user’s authority to operate the equipment.
0351A EN 20190319 1349 *

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DR 10s

0351A EN 20190319 1349 *

0351A EN 20190319 1349 *

Cleaning and Disinfecting ........................................ 44

0351A EN 20190319 1349 *

Battery thermal protection ...........................96

0351A EN 20190319 1349 *

THALES AVS FRANCE SAS, 460 rue du Pommarin, 38430 MOIRANS

Copyright 2019 Agfa NV

All rights reserved.

No part of this document may be reproduced, copied, adapted or transmitted

0351A EN 20190319 1349 *

Introduction to this Manual

0351A EN 20190319 1349 *

0351A EN 20190319 1349 *

About the safety notices in this document

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

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

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

0351A EN 20190319 1349 *

0351A EN 20190319 1349 *

Introduction to the DR Detector

0351A EN 20190319 1349 *

Indications for Use

0351A EN 20190319 1349 *

1. X-ray generator synchronization through the DR Generator Sync Box

0351A EN 20190319 1349 *

Class I equipment Internally powered

Type B equipment A Type B piece of equipment is one that provides a

Applied Parts The DR Detector tube side is an applied part.

Operation Continuous operation.

Estimated product Up to ten (10) years

0351A EN 20190319 1349 *

Figure 3: Patient’s vicinity

0351A EN 20190319 1349 *

Options and Accessories

0351A EN 20190319 1349 *

0351A EN 20190319 1349 *

1. Effective imaging area border and center position indication

0351A EN 20190319 1349 *

DR Detector Battery Charger

1. Battery status indicator light

0351A EN 20190319 1349 *

DR Detector Switch on the NX Workstation

It is positioned in the title bar of the NX application.

Battery status (empty)

Meaning Full Medium Low Empty Wired DR Detector

Meaning Good Low Bad Wired DR DR Detec-

0351A EN 20190319 1349 *

Meaning DR Detec- DR Detector is DR Detector is DR Detector is

DR Detector exposure synchronization

Automatic expo- (empty)

Meaning The active DR Detector is The active DR Detector is

Note: Depending on the installed software version, the icon may

0351A EN 20190319 1349 *

IR Data Communication Unit

0351A EN 20190319 1349 *

Wireless Access Point

0351A EN 20190319 1349 *