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HEALTHCARE

Imaging Services Installation Procedure


Document No: DD+DIS026.12E
This number is needed for production line only:
A601412.3 CR 30-X 2nd
Type 5175 / 200 / 205 / 220 / 225

CR 30-Xm
Type 5179 / 100

This document is provided as an enclosure to the product. It consists of following documents:


 Installation Planning DD+DIS229.10E Edition 1, Revision 1
 Generic Safety Directions DD+DIS238.06E Edition 1, Revision 3
 Controls, Connections and Set Up Procedures DD+DIS230.10E Edition 1, Revision 4

This document is separately available. Order number: DD+DIS026.12E

CONFIDENTIALITY NOTE:
Use, dissemination, distribution or reproduction of this document by unauthorized personnel is not permitted and may be unlawful.
DOCUMENT CONTROL NOTE:
The controlled version of this document is available from the Agfa HealthCare Library. Any printed copy of this document is uncontrolled.

Revision 0
02-2012 Printed in Germany Document Node ID: 35981874
eq_installation-procedure-cover_e_template_v08
Agfa Company Confidential Copyright © 2012 Agfa HealthCare N.V.
DD+DIS026.12E Installation Procedure

► Manufacturer
Agfa HealthCare N.V.

Published by
Agfa-Gevaert HealthCare GmbH
Tegernseer Landstraße 161
D - 81539 München
Germany
Copyright  2012 Agfa HealthCare N.V.
All rights reserved.
Technical modifications reserved.
Agfa and the Agfa rhombus are trademarks of Agfa-Gevaert N.V., Belgium,
or its affiliates.

WARNING:
Improper operation or service activities may cause damage or injuries.

INSTRUCTION:
(1) Read the "Generic Safety Directions" document
(see Agfa HealthCare Library > General Info > Agfa HealthCare > Publications >
Service Manual) prior to attempting any operation, repair or maintenance task on
the equipment.
(2) Strictly observe all safety directions within the "Generic Safety Directions" and on
the product.

DOCUMENT CONTROL NOTE:


The controlled version of this document is available from the Agfa HealthCare Library. Any printed copy of this document is uncontrolled.

Revision 0 CR 30-X 2nd, Type 5175 / 200 / 205 / 220 / 225 Page 2 of 4
02-2012 CR 30-Xm, Type 5179 / 100 Agfa Company Confidential
DD+DIS026.12E Installation Procedure

► Purpose of this Document

This document is included in the machine delivery.


It contains all information needed for the installation.

► Document History

Revision Release Changes


Date
0 02-2012 Initial Release

► Referenced Documents

Document Title
Not applicable

DOCUMENT CONTROL NOTE:


The controlled version of this document is available from the Agfa HealthCare Library. Any printed copy of this document is uncontrolled.

Revision 0 CR 30-X 2nd, Type 5175 / 200 / 205 / 220 / 225 Page 3 of 4
02-2012 CR 30-Xm, Type 5179 / 100 Agfa Company Confidential
DD+DIS026.12E Installation Procedure

THE INSTALLATION PROCEDURE CONSISTS OF THE FOLLOWING THREE


OWNSTANDING DOCUMENTS:

1.
INSTALLATION PLANNING...................................................................DD+DIS229.10E

2.
GENERIC SAFETY DIRECTIONS .........................................................DD+DIS238.06E

3.
CONTROLS, CONNECTIONS AND SETUP PROCEDURE ................DD+DIS230.10E

DOCUMENT CONTROL NOTE:


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Revision 0 CR 30-X 2nd, Type 5175 / 200 / 205 / 220 / 225 Page 4 of 4
02-2012 CR 30-Xm, Type 5179 / 100 Agfa Company Confidential
HEALTHCARE Chapter 11
Imaging Services Installation Planning
Document No: DD+DIS229.10E

CR 30-X 2nd
Type 5175 / 200 / 205 / 220 / 225

CR 30-Xm
Type 5179 / 100

► Purpose of this Document

This document contains all planning data including the required measures to be carried
out on site prior to the machine delivery.
This chapter is divided into:
• Construction planning data
• Technical connection and performance data
• Safety instructions, listing of certificates

► Document History

Edition. Release Changes


Revision Date compared to previous Version 1.0
1.1 02-2012 • Updated AE-Title in section 4.1.
• Updated dimensions of the digitizer in section 7.
• Added information about CR 30-Xm.

► Referenced Documents

Document Title
Not applicable

DOCUMENT CONTROL NOTE:


The controlled version of this document is available from the Agfa HealthCare Library. Any printed copy of this document is uncontrolled.

Edition 1, Revision 1
02-2012 Printed in Germany Document Node ID: Node ID
eq_11_install-planning_e_template_v08
Agfa Company Confidential Copyright © 2012 Agfa HealthCare N.V.
1 2 3
DD+DIS229.10E Installation Planning

► Manufacturer
Agfa HealthCare N.V.

Published by
Agfa-Gevaert HealthCare GmbH
Tegernseer Landstraße 161
D - 81539 München
Germany
Copyright © 2012 Agfa HealthCare N.V.
All rights reserved.
Technical modifications reserved.
Agfa and the Agfa rhombus are trademarks of Agfa-Gevaert N.V., Belgium,
or its affiliates.

WARNING:
Improper operation or service activities may cause damage or injuries.

INSTRUCTION:
(1) Read the "Generic Safety Directions" document
(see Agfa HealthCare Library > General Info > Agfa HealthCare > Publications >
Service Manual) prior to attempting any operation, repair or maintenance task on
the equipment.
(2) Strictly observe all safety directions within the "Generic Safety Directions" and on
the product.

IMPORTANT:
The installation and service of the product(s) described herein is to be performed
by qualified personnel who are employed by Agfa HealthCare or one of its affiliates
or who are otherwise authorized by Agfa HealthCare or one of its affiliates to provide
such services.

NOTE:
To verify the latest version of a chapter of the Service Manual refer to the “Checklist for
Completeness” in the Agfa HealthCare Library.

DOCUMENT CONTROL NOTE:


The controlled version of this document is available from the Agfa HealthCare Library. Any printed copy of this document is uncontrolled.

Edition 1, Revision 1 CR 30-X 2nd, Type 5175 / 200 / 205 / 220 / 225 Chapter 11 / Page 2 of 30
02-2012 CR 30-Xm, Type 5179 / 100 Agfa Company Confidential
1 2 3
DD+DIS229.10E Installation Planning

LIST OF CONTENTS

1 PRODUCT DESCRIPTION ......................................................................................................5


1.1 System Overview ......................................................................................................................5

1.2 Workflow of a CR 30-X 2nd / CR 30-Xm System .....................................................................6

2 SCOPE OF DELIVERY AND ACCESSORIES.........................................................................7


2.1 Scope of Delivery......................................................................................................................7

2.2 Accessories...............................................................................................................................8

3 ROOM PREPARATION............................................................................................................9
3.1 Minimum required free Space for Operation and Maintenance................................................9

4 SYSTEM INTEGRATION .......................................................................................................10


4.1 Integration of the CR 30-X 2nd / CR 30-Xm into the Hospital Network ..................................10

5 CLIMATIC AND AMBIENT CONDITIONS..............................................................................12


5.1 Conditions during Transport and Storage...............................................................................12

5.2 Conditions during Operation ...................................................................................................13

6 ELECTRICAL CONNECTIONS ..............................................................................................14


6.1 Electrical Connections at the Digitizer ....................................................................................17

6.2 Electrical Connections at the optional UPS ............................................................................17

7 DIGITIZER DIMENSIONS AND WEIGHT ..............................................................................18


7.1 Digitizer with closed Covers....................................................................................................18

7.2 Digitizer with Front Cover opened...........................................................................................18

7.3 Dimensions of the Digitizer including Packaging ....................................................................19

7.4 Dimensions of the Pallet .........................................................................................................19

7.5 Weight of the Digitizer.............................................................................................................19

7.6 Dimensions of the All-in-one Cart (Optional) ..........................................................................20

8 SPECIFICATIONS..................................................................................................................21
8.1 Type Overview ........................................................................................................................21

8.2 Functional Data .......................................................................................................................22

8.3 Resolution ...............................................................................................................................22

8.4 Electrical Data of Digitizer.......................................................................................................23

DOCUMENT CONTROL NOTE:


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Edition 1, Revision 1 CR 30-X 2nd, Type 5175 / 200 / 205 / 220 / 225 Chapter 11 / Page 3 of 30
02-2012 CR 30-Xm, Type 5179 / 100 Agfa Company Confidential
1 2 3
DD+DIS229.10E Installation Planning

8.5 Functional Data of the optional UPS.......................................................................................23

8.6 Climatic Data...........................................................................................................................23

8.7 Acoustic Noise Level...............................................................................................................23

8.8 Boot-up Time and Warm-up Time...........................................................................................24

8.9 Interface Data..........................................................................................................................24

8.10 Service Data............................................................................................................................24

8.11 Functional Data Image Plates.................................................................................................24

9 SAFETY STANDARDS...........................................................................................................25
10 INSTALLATION PLANNING CHECKLIST..............................................................................27
10.1 Installation Planning Checklist ................................................................................................27

10.2 Installation Readiness Checklist .............................................................................................29

DOCUMENT CONTROL NOTE:


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Edition 1, Revision 1 CR 30-X 2nd, Type 5175 / 200 / 205 / 220 / 225 Chapter 11 / Page 4 of 30
02-2012 CR 30-Xm, Type 5179 / 100 Agfa Company Confidential
1 2 3
DD+DIS229.10E Installation Planning

1 Product Description

This document describes the installation planning of the CR 30-X 2nd digitizer.

The CR 30-X 2nd, Type 5175 comprises the following subtypes:


• Type 5175, subtype 200 = CR 30-X 2/60 Digitizer
• Type 5175, subtype 205 = CR 30-X 2/35 Digitizer
• Type 5175, subtype 220 = CR White 2/60 Digitizer
• Type 5175, subtype 225 = CR White 2/35 Digitizer

The CR 30-X 2nd, Type 5179 comprises the following subtypes:


• Type 5179, subtype 100 = CR 30-Xm

The differences between the different types are described in section 8.1 and 8.2.

For the installation of the complete system it is additionally required to perform


all steps described in the NX Workstation Installation Planning document.
Refer to the Agfa HealthCare Library:
<Computed Radiography Æ CR Workstation Software>

1.1 System Overview

The CR 30-X 2nd / CR 30-Xm digitizer is part of the CR system, consisting of:
• Digitizer
• Cassettes with Image Plate (IP)
• NX Workstation

NX Workstation NX Workstation
Digitizer Tower Version Digitizer Laptop Version *

Cassette Cassette

Figure 1
* Mammography application not available on the laptop version of the NX Workstation.
For compatibility of the Laptop Version check the CR/DR Interoperability Matrix,
Document ID 31333326 (Intranet Link / Extranet Link)

DOCUMENT CONTROL NOTE:


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Edition 1, Revision 1 CR 30-X 2nd, Type 5175 / 200 / 205 / 220 / 225 Chapter 11 / Page 5 of 30
02-2012 CR 30-Xm, Type 5179 / 100 Agfa Company Confidential
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DD+DIS229.10E Installation Planning

1.2 Workflow of a CR 30-X 2nd / CR 30-Xm System

The following figure indicates a typical workflow of a CR 30-X 2nd / CR 30-Xm system:

1
Take exposure.

5
Take cassette
for next exposure.
2
Insert exposed cassette
in digitizer:
The image plate is prepared
for scanning

3
Go to NX Workstation
and select patient:
The digitizer starts scanning

4
Wait till image plate cycle
is finished (approximately 1 minute). 517502ah.cdr

Figure 2

Step 1: Take the exposure.


Step 2: Insert the exposed cassette into the digitizer.
Step 3: Go to the NX workstation. Select the patient from the worklist and
select the ID* button. The IP** cycle starts.
Step 4: Wait till the IP** cycle is finished.
For the CR 30-X 2nd subtypes 200 and 220 it takes approximately
1 minute.
For the CR 30-X 2nd subtypes 205 and 225 it takes approximately
1.5 minutes.
For the CR 30-Xm subtype 100 it takes approximately 2 minutes.
The digitizer sends the image data during scanning (i.e. during the
IP cycle) to the NX workstation.
Step 5: Take out the cassette for the next examination.
* ID = Identify
** IP = Image Plate

DOCUMENT CONTROL NOTE:


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Edition 1, Revision 1 CR 30-X 2nd, Type 5175 / 200 / 205 / 220 / 225 Chapter 11 / Page 6 of 30
02-2012 CR 30-Xm, Type 5179 / 100 Agfa Company Confidential
1 2 3
DD+DIS229.10E Installation Planning

2 Scope of Delivery and Accessories


2.1 Scope of Delivery

Quantity Description
1 Digitizer
1 Packing list for Accessory
1 CE declaration of conformity
1 Enclosure with information concerning RoHS*
1 Installation Procedure, DD+DIS148.11E
(Chapters 1 and 11 of the Technical Documentation)
1 Power cable, Europe 3.00 m
1 Power cable, US 3.00 m
1 Network cable 5 m / 16 feet long
1 1.5 mm CU filter
1 2.0 mm Al filter
1 USB stick with Software for the digitizer
1 Torx Key TX20
1 Torx Key TX45
1 CD with limit patterns for flatfield evaluation
1 CD with User Manuals in all specified languages**
* RoHS = Restriction of the use of certain Hazardous Substances
** Language: Chinese-simplified, Chinese-traditional, Czech, Danish, Dutch, English, Finnish, French,
German, Greek, Italian, Korean, Norwegian, Polish, Portuguese, Russian, Spanish, Swedish, Thai,
Vietnamese, Estonian, Hungarian, Latvian, Lithuanian, Slovak, Slovenian, Turkish

IMPORTANT:
The digitizer is ordered and delivered with a dedicated NX workstation.
The CR 30-X 2nd requires at least NX2.0.8500 or higher, the CR 30-Xm requires
NX2.0.8600 or higher.
It is not possible to connect the digitizer to another type of Agfa CR workstation
(e.g. QS 3.5).
IMPORTANT:
The digitizer is delivered with two power cables for US/Europe. If digitizer is installed
outside the US or Europe, organize a power cable for your country locally.
For detailed specifications refer to section 6, Electrical Connections.
NOTE:
The digitizer is delivered with all parts, which are required to set up the device
into operation.
Number and format of cassettes / image plates are depending on the individual order.

DOCUMENT CONTROL NOTE:


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Edition 1, Revision 1 CR 30-X 2nd, Type 5175 / 200 / 205 / 220 / 225 Chapter 11 / Page 7 of 30
02-2012 CR 30-Xm, Type 5179 / 100 Agfa Company Confidential
1 2 3
DD+DIS229.10E Installation Planning

2.2 Accessories

The following accessories are available for the CR 30-X 2nd / CR 30-Xm digitizer:

Warning:
Images can be lost due to power failure.
Connect the equipment to an un-interruptible power supply (UPS) or an institutional
standby generator.

Item ABC Code Comment


All-in-one cart E2M3H For dimensions refer to section 7.6.
UPS Powerware 5115, EGPSE Can be used for digitizer and NX.
120 V Version For technical specifications refer to
section 8.
UPS Powerware 5115, EGPTG
220 V Version See safety note below.
Mobile Kit EWRQ5 To be used in earthquake areas and in
mobile usage. May not be used in military
vessels.

Rear Mounting Plate

Retainers for digitizer feet

Base Plate
517511bb.cdr

Remote Service Not applicable See NOTE below.


Table EWRP3 For dimensions refer to section 3.1

NOTE to Accessory "Remote Service":


In general it is possible to diagnose and repair the digitizer to a certain extent remotely.
To enable remote service of the digitizer remote access has first to be organized.
Remote Access is established via the Agfa own Secure Remote Service System
(SRSS).
For more information to the SRSS see Agfa HealthCare Library*:
<Technical Services Æ Service Delivery Æ SRSS>
* Only applicable for Agfa Employees.
For external partners: Contact your local Agfa partner.

DOCUMENT CONTROL NOTE:


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Edition 1, Revision 1 CR 30-X 2nd, Type 5175 / 200 / 205 / 220 / 225 Chapter 11 / Page 8 of 30
02-2012 CR 30-Xm, Type 5179 / 100 Agfa Company Confidential
1 2 3
DD+DIS229.10E Installation Planning

3 Room Preparation
3.1 Minimum required free Space for Operation and Maintenance

CAUTION:
Reduced airflow may lead to pollution in the digitizer.
Keep a minimum of 5 cm (2 inches) between rear side of the digitizer and the wall.
At least 50 cm [19.7 in] space has to be provided on the right hand side to allow
cleaning of the scan line with the cleaning brush. This can be performed by the
customer.

NOTE:
The floor of the installation place must be stable and may not transmit mechanical
vibrations as e.g. footfall sound.
If installed on the optional All-in-one Cart the digitizer can also be installed in a corner;
see section 7.6, Dimensions of the All-in-one Cart.

> 50 [19.7]
> 5 [2.0] *

60 [23.6] 60 [23.6]

80 [31.5] 80 [31.5]

60 [23.6] 60 [23.6]
537511ac.ai

Figure 3: Scale 1:20; Dimensions are in cm [inch]

IMPORTANT:
*The clearance in the rear for electrical connectors and to provide sufficient air flow
has to be at least 5 cm [2.0 in] in any case.

DOCUMENT CONTROL NOTE:


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Edition 1, Revision 1 CR 30-X 2nd, Type 5175 / 200 / 205 / 220 / 225 Chapter 11 / Page 9 of 30
02-2012 CR 30-Xm, Type 5179 / 100 Agfa Company Confidential
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DD+DIS229.10E Installation Planning

4 System Integration

(1) Download following documents before installation.


• Solution Structure Data Document, Document ID* 30781759
(Intranet Link / Extranet Link)
• CR/DR Interoperability Matrix, Document ID* 31333326,
(Intranet Link / Extranet Link)

(2) By means of these documents check, whether the new ordered system
components and the already available equipment on site (if available) can be
used together in the system.
* Access the document by entering the document ID in the Agfa HealthCare Library search window,
or follow the direct link.

4.1 Integration of the CR 30-X 2nd / CR 30-Xm into the Hospital Network

WARNING:
When different combinations of equipment are used in various medical
environments a potential difference (V) can exist between the protective earths
in different localities. If the protective earthing fails this potential difference can
cause a HAZARD for the OPERATOR or for the PATIENT.
• To comply with ISO 60601-1 (annex I) all computers and peripherals must be
connected to the same power source.
• Always connect the associated monitor to the same Uninterruptible Power
Source (UPS) as the PC.

WARNING:
The digitizer is heavy (72.0 kg; 158.73 lb). Risk of injuries when lifting the
digitizer.
• At least two persons have to lift the digitizer from one position to the other.
• When removing scanner only one person is needed to lift the digitizer from one
position to the other.
• Use proper shoe and hand protection when lifting the digitizer.

DOCUMENT CONTROL NOTE:


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Edition 1, Revision 1 CR 30-X 2nd, Type 5175 / 200 / 205 / 220 / 225 Chapter 11 / Page 10 of 30
02-2012 CR 30-Xm, Type 5179 / 100 Agfa Company Confidential
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DD+DIS229.10E Installation Planning

WARNING:
Excessive vibrations during scanning may decrease image quality.
The structure and stability of the used table need to be suitable in relation with the size
and weight of the system. The table may not be subject to excessive shock and
vibrations from other sources.

IMPORTANT:
• Unpacking of the digitizer and putting on the table should be done by the
forwarder. For more information refer to the Unpacking instructions.
• Recommended table height: 75 cm
• Due to the workflow* of the system it is recommended to install digitizer and
NX workstation close together.
* The operator has to go from digitizer to the NX workstation and back to the digitizer for each
scan cycle.

• If the laptop version of the NX workstation is used:


Do not place the laptop on top of the CR 30-X 2nd / CR 30-Xm, because the
accumulated heat developed by the digitizer and the laptop may affect the
operation of the system.

The digitizer has to be connected to the NX workstation via network cable,


either directly or via hospital network
The NX workstation and the CR30-X 2nd or CR 30-Xm Digitizer always belong
together, meaning that each CR Digitizer has to be connected to one dedicated NX
workstation.

The following table gives information about the default parameter of Digitizer ex factory.

Parameter: Default value: Value:

IP Address: 192.192.192.192 ..............................................


Subnet Mask: 255.255.255.0 ..............................................
Gateway IP Address: 192.192.192.1 ..............................................
AE Title: DIG_DEFAULT ..............................................
Hostname: 192.192.192.192 ..............................................

DOCUMENT CONTROL NOTE:


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02-2012 CR 30-Xm, Type 5179 / 100 Agfa Company Confidential
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DD+DIS229.10E Installation Planning

5 Climatic and ambient Conditions


5.1 Conditions during Transport and Storage

Environmental conditions According IEC721-3-1: 1K2 (CR 30-X) / 1K4 (CR


during storage 30-Xm) and 1M2
Temperature Minimum: -25 °C (-13 °F)
Maximum: +55 °C (131 °F)

Environmental conditions According IEC721-3-2: 2K2 and 2M2


during transport
Temperature Minimum: -25 °C (-13 °F)
Maximum: +60 °C (140 °F)
Vibration 5-200 Hz (vertical, longitudinal, transversal axis)

Environmental conditions for According IEC 721-3-5: 5K2 and 5M2


mobile installation during
transport
Vibration 5-150 Hz (all axis), 1m/s², sinusoidal vibration

For transport in mobile According IEC TR 60721-4-5 (1997): class 5M2.


installations
(device unpacked, with wall
fixture kit, not in function)

DOCUMENT CONTROL NOTE:


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02-2012 CR 30-Xm, Type 5179 / 100 Agfa Company Confidential
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DD+DIS229.10E Installation Planning

5.2 Conditions during Operation

IMPORTANT:
Make sure that the digitizer is not exposed to any vibrations or shocks during
operation.

Ambient temperature Recommended: 20 °C (68 °F) to 25 °C (77 °F)


Allowed: 15 °C (59 °F) to 30 °C (86 °F)
Temperature change Maximum: 0,5 °C/min
Relative humidity Recommended: 30 % to 60 %
Allowed: 15 % to 75 % (non-condensing)
Magnetic field Maximum 3.8 µT in conformance with
EN6100-4-8: Level 2
Radiation influences If the digitizer is installed in the x-ray room,
it has to be protected against scatter radiation.

Environmental conditions for According IEC721-3-3: 3K2 and 3M1


mobile installation during
operation
Temperature Minimum: +15 °C (59 °F)
Maximum: +30 °C (86 °F)
Relative humidity Minimum: 15 %
Maximum: 75 %
Vibration 40-200 Hz; 1m/s²; sinusoidal vibration

WARNING:
Image plate is sensitive for X-rays. Poor image quality possible.
The digitizer and the cassette storage shall be protected against X-ray radiation this
way, that the annual dose equivalent at the installation place will not exceed 1 mSv.

Ambient Light The digitizer may not be operated in direct


(Environmental light condition) sun light. No influence on image quality is
guaranteed if operated in ambient light of
maximum 2500 Lux.
High Frequency Emission and For detailed information refer to the digitizer
Immunity user manual.

DOCUMENT CONTROL NOTE:


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02-2012 CR 30-Xm, Type 5179 / 100 Agfa Company Confidential
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DD+DIS229.10E Installation Planning

6 Electrical Connections

WARNING:
Electrical device. Shock possible.

INSTRUCTION:
• Position the Agfa products so that it is possible to disconnect the mains power
connection if required.
• Local and International wiring regulations must be observed. Check all supplies
and voltages, currents, trips and fuses with the Hospital facilities department or
their engineers.

Installation Electrical installations have to be done in accordance with


guidelines national regulations or statutory requirements, e.g.:
VDE: Electrical installations in the installation room
(Germany) must be in compliance with the regulations IEC
364, VDE 0100, and VDE 0107.
UL: (US) Electrical installations in the installation room
must be in compliance with the regulations:
“National Electrical Code" (NEC) (NFPA70).
Mains connection VDE: Double earthed pin outlet in compliance with
in the installation (Germany) DIN 49441 and with CEE 7 standard cover V II.
room UL: (US) Earthed contact outlet for the NEMA 5-15 P plug
Mains cable Euro- CEE7/7 - H05VV -
(part of delivery) Version: F3G1 - 3 x 1 mm² with
IEC C13 plug (female);
cable length 3 m CEE7/7

IEC C13
5175_C11_001.cdr

US/CAN- NEMA 5-15P - SJT,


Version: 3 x AWG 18 with
IEC C13 plug (female);
Cable length 3 m, IEC C13
Hospital grade (HG)
NEMA 5-15P 5175_C11_002.cdr

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02-2012 CR 30-Xm, Type 5179 / 100 Agfa Company Confidential
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DD+DIS229.10E Installation Planning

NOTE:
The digitizer is delivered with two power cables for US/Europe. If a different cable is
needed, organize it locally but keep attention to country specific requirements.

Example:
Power cable to be organized locally for US/CAN, if a connection to a 240 V-outlet
instead of the standard 120 V-outlet is needed:
NEMA 6-15P - SJT,3 x AWG 18 with IEC C13 connector (female); Hospital grade (HG)

Network cable UTP; AWG24; Length: 5 m


(part of delivery)
Mains switch Upon digitizer installation, it must be ensured that either the
mains connector or an all-pole circuit breaker for the
installation on site is located close to the machine and easily
accessible.

Cables for the optional UPS:

NOTE:
The following cables listed in the tables on next page are only used for the
recommended UPS Powerware 5115. If another UPS Powerware model is used the
cables may change.
For more Information refer to provided UPS Manual.

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DD+DIS229.10E Installation Planning

UPS Powerware 5115 1 Serial cable; part of UPS delivery


230 V Version* 2 Extension cable (1.8 m); part of UPS delivery
3 Extension cable (1.8 m); part of UPS delivery
4 Mains cable; part of digitizer delivery
*Check which UPS Powerware is needed for the CR 30-X 2nd / CR 30-Xm installation. If another UPS
Powerware version needs to be used, the cables listed in the table may change.

230 V (220 - 240 V) Version


Type 5115 - 750i
2 1
3

4
to wall outlet

Figure 4

UPS Powerware 5115 5 Mains cable; part of digitizer delivery


120 V Version*
6 Mains cable; part of NX delivery
7 Serial cable; part of UPS delivery
8 Fixed SJT, 3 x AGW 18 with NEMA 5-15 P
plug: 1.8 m
*Check which UPS Powerware is needed for the CR 30-X 2nd / CR 30-Xm installation. If another UPS
Powerware version needs to be used, the cables listed in the table may change.

120 V (110 - 120 V) Version


Type 5115 - 750
7
5
6

8
to wall outlet

Figure 5

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6.1 Electrical Connections at the Digitizer

The following figure shows the electrical connections at the digitizer:

Power Supply Input


100 - 240 V / 50 - 60 Hz AC

Mains Switch Intergrounding


Connector

Network Connector
517511ad.cdr

Figure 6

6.2 Electrical Connections at the optional UPS

The following Figure shows an example of the electrical connections


at the optional UPS:

230 V (220 - 240 V) Version 120 V (110 - 120 V) Version


Type 5115 - 750i Type 5115 - 750

Serial Port Serial Port


(to NX Workstation) (to NX Workstation)

Four 10 A, IEC-320 Four 5 - 15


Receptacles Receptacles

10 A, IEC-320 Power cord ( 6ft / 1.8 m)


Input Connector with 5 - 15 Plug

517511aj.cdr

Figure 7

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7 Digitizer Dimensions and Weight


7.1 Digitizer with closed Covers

Dimensions in cm [inch]

52.5 [20.7]

78.6 [30.9] 69.3 [27.2]

Figure 8

Length 78.6 cm / 30.9 inch


Width 69.3 cm / 27.2 inch
Height 52.5 cm / 20.7 inch

7.2 Digitizer with Front Cover opened

Dimensions in cm [inch]

52.5 [20.7]

100.2 [39.5] 69.3 [27.2]

Figure 9

Length 100.2 cm / 39.5 inch


Width 69.3 cm / 27.2 inch
Height 52.5 cm / 20.7 inch

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7.3 Dimensions of the Digitizer including Packaging

Length 90 cm / 35.4 inch


Width 80 cm / 31.5 inch
Height 69 cm / 27.2 inch

7.4 Dimensions of the Pallet

Length 90 cm / 35.4 inch


Width 80 cm / 31.5 inch
Height inclusive palette 15 cm / 6 inch

7.5 Weight of the Digitizer

Digitizer alone 72.0 kg / 158.73 lb


Digitizer with packing inclusive 106.5 kg / 234.8 lb
palette

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7.6 Dimensions of the All-in-one Cart (Optional)

For the CR 30-X 2nd / CR 30-Xm digitizer is an All-in-one Cart available.

NOTE:
The already existing All-in-one Cart of the CR 30-X digitizer (Type 5175 / 100 / 105 /
110 / 120 / 125) with SN < 3.000 requires the installation of an "Adaptor base plate" to
make them compatible for the CR 30-X 2nd (Type 5175 / 200 / 205 / 220 / 225) or
CR 30-Xm (Type 5179 / 100) digitizer.

The adaptor base plate can be ordered with spare part number*: CM+6027470
* The last digit in the spare part number indicates the spare part revision at release of this document.
When ordering, the actual revision of the spare part is delivered.

IMPORTANT:
If the customer uses a different table, observe the stability of the table: It must be able
to carry the weight of 72.0 kg (158.73 lb) and may not be subject to excessive shock
and vibrations from other sources.
WARNING:
Excessive vibrations during scanning may decrease image quality.
The structure and stability of the used table need to be suitable in relation with the size
and weight of the system. The table may not be subject to excessive shock and
vibrations from other sources.

The All-in-one cart consists of:


• Table for digitizer
• Storage for cassettes
• Storage of NX workstation, inclusive:
o Monitor
o Keyboard
o Mouse
• Storage of optional UPS

Figure 10

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Dimensions of the All-in-one Cart:

155 cm [61 1"]

.
FRONT LEFT
75,7 cm [29 8"]

70,0 cm [27.6"]
77,0 cm [30 3"]

TOP

5175_c11_002.ai

Figure 11: Dimensions in cm [inch]

8 Specifications
8.1 Type Overview

Type ABC Code Serial Number


5175 / 200 5QTR4 ≥ 50.001
5175 / 205 5RVQK ≥ 80.001
5175 / 220 5RVRM ≥ 70.001
5175 / 225 5RVSO ≥ 85.001
5179 / 100 5SDMH ≥ 1.001

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8.2 Functional Data

Cassette Type Format Resolution Width x Length Width x Length


(cm) (pixel/mm) (pixels) (mm)
CR MD4.0T 15 x 30 10 1440 x 2928 144.0 x 292.8
General plate
18 x 24 10 1728 x 2328 172.8 x 232.8
and cassette
(GenRad PIP) 24 x 30 10 2328 x 2928 232.8 x 292.8
35 x 35 10 3480 x 3480 348.0 x 348.0
35 x 43 10 3480 x 4248 348.0 x 424.8
CR MD4.0T 35 x 43 10 3480 x 4406 348.0 x 440.6
FLFS cassette
(GenRad PIP)
CR MM3.0T 24 x 30 20 4710 x 5844 471.0 x 584.4
Mammo plate
18 x 24 20 3510 x 4644 351.0 x 464.4
and cassette

Throughput Cassette Format Minimum Number of


Cassettes per hour
Type 5175 / 200 35 x 43 60
Type 5175 / 205 35 x 43 35
Type 5175 / 220 35 x 43 60
Type 5175 / 225 35 x 43 35
Type 5179 / 100 24 x 30 32

8.3 Resolution

Bits per pixel / number of grey steps 16 / 65535


Scan Resolution 50 / 100 μm depending on
used image plate
(Mammo / Genrad)
Data acquisition 20 Bits/Pixel
Output to processor 16 Bits/Pixel square root
compressed

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8.4 Electrical Data of Digitizer

Rated voltage 100 - 240 V AC (autosensing)


Frequency 50/60 Hz
Current 1.0 A – 2.0 A

8.5 Functional Data of the optional UPS

Rated voltage UPS Powerware 120 V = Default


5115-750 (ABC Code: EGPSE)* 110 V = User adjustable via rear panel
DIP switches
Rated voltage UPS Powerware 230 V = Default
5115-750i (ABC Code: EGPTG)* 220 or 240 V = User adjustable via rear
panel DIP switch
Frequency 50/60 Hz (autosensing)
Battery runtime > 5 min
Output Power 750 W
Dimensions (HxWxD) 192 x 150 x 270 mm /
7.6 x 5.9 x 10.6 inch
Weight 7.8 kg / 17.2 lb
More info Refer to www.powerware.com

8.6 Climatic Data

CR 30-X 2nd Standby: 60 W = 204 BTU/h


Heat emission Maximum: 190 W = 648 BTU/h
Average of one cycle: 85 W = 290 BTU/h

CR 30-Xm Standby: 60 W = 204 BTU/h


Heat emission Maximum: 220 W = 751 BTU/h
Average of one cycle: 103 W = 351 BTU/h

8.7 Acoustic Noise Level

Acoustic Noise Level Standby: 55 dB(A) maximum


according ISO 7779 During scanning: 65 dB(A) maximum

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8.8 Boot-up Time and Warm-up Time

Cold start Fully operational after max. 30 min.


Warm start Fully operational after self-test, on condition
that the digitizer:
• has not been switched off for more than 3
minutes.
• has been operational for at least 30
minutes.

8.9 Interface Data

Interface to NX workstation Ethernet, RJ45 connector (female),


10/100 Mbit/s autosensing *,
shielding CAT5
* Gigabit Ethernet is not supported.

8.10 Service Data

Info counter Yes


Service User Interface via Browser access Yes
Remote / preventive service capable Yes

8.11 Functional Data Image Plates

Image plate type CR MD4.0T


Image retention Within 1 hour Recommended readout time
After 2 hours 80 % of the stored energy is still present with
no visible loss of information upon readout.
After 24 hours Image retention still exceeds 50 %.
Slightly reduced images quality

Image plate type CR MM3.0T


Image retention Within 1 hour Recommended readout time
After 2 hours 80 % of the stored energy is still present with
no visible loss of information upon readout.
After 24 hours Image retention still exceeds 50 %.
Slightly reduced images quality

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9 Safety Standards

The digitizer complies with:

North American Standards European Norm and International


Federal Communications Commission Standards
Canadian Standards Association European Norm
Underwriters Laboratories International Electrotechnical Commission
Code of Federal Regulations

EMC* • ISO 14971:2009, Medical • EN 540: 1993


devices - Application of risk
management to medical devices. • EN 980: 2008
• EN 1041: 2008
• ISO 18906: 2000
• EN ISO 13485: 2003 / AC: 2009
Safety • UL 60601-1:2003 • IEC 60601-1 / EN 60601-1
• CAN / CSA 22.2 No. 601.1 • IEC 60601-1-1:2000 /
EN 60601-1-1:2001
• IEC 62304:2006 /
EN 62304:2006
• IEC 60601-1-6:2006 /
EN 60601-1-1:2007
• IEC 60601-1-2: 2007 /
EN 60601-1-2:2007
• ISO 14971:2009, Medical devices -
Application of risk management to
medical devices
Additional • IEC 62079 Ed. 1: Preparation of
instructions - Structuring, content
and presentation

* EMC = Electromagnetic Compatibility

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The leakage current limits for which this device is tested, excludes installation in the
patient vicinity. Therefore the equipment must be placed outside the patient vicinity
according to the local valid regulation (UL 60601-1 or EN 60601-1).
The patient vicinity is defined as follows:
• UL 60601-1:
o 1.83 m (6 feet) beyond the perimeter of the bed (examination table, dental chair,
treatment booth, and the like)
o Vertical 2.29 m (7.5 feet) above the floor

• EN 60601-1:
o 1.5 m (4.9 feet) beyond the perimeter of the bed (examination table, dental
chair, treatment booth, and the like)
o Vertical 2.5 m (8.2 feet) above the floor

R
Patient vicinity
h

Patient vicinity

patient_vicinity.cdr

R = 1.5 m / 4.9 feet (EN 60601-1) or 1.83 m / 6 feet (UL 60601-1)


h = 2.5 m / 8.2 feet (EN 60601-1) or 2.29 m / 7.5 feet (UL 60601-1)
Figure 12
• Other equipment that is in contact with the patient is not connected directly
to the Agfa system without additional protective measures.

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10 Installation Planning Checklist


10.1 Installation Planning Checklist

# Step Goal Section OK Task


code*
1. Ask the Agfa sales To schedule an installation date
representative for a with the customer.
contact person in - PRI**
To get the list of ordered
the hospital.
equipment that needs to be
installed.
2. Make yourself To see in which environment the
familiar with the digitizer will be installed. 0 PRI
System Overview.
3. Make yourself Basic information, to see
familiar with the whether additional, site specific
2.1 PRI
scope of delivery. material for installation might be
required.
4. Make yourself Hospital employees are involved
familiar with the in installation and operation of
8 PRI
digitizer the digitizer and the list about
specifications. technical specifications.
5. Check the digitizer Customer / Operator knows the
safety standards safety standards and regulations 9 PRI
and regulations. of the digitizer.
6. Check the machine To check the transport path and
dimensions. the desired installation place for 7 PRI
sufficient space.
7. Ensure the required Installation location complies
free space around with the requirements for
3.1 PRI
the digitizer. minimum floor space for
operation and service.
* Task Code, only applicable for Agfa employees
** PRI = Pre-Installation

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# Step Goal Section OK Task


code*
8. Make an Physical network access is
appointment with granted.
the network
IP addresses at hand during
administrator and
installation
check the network
- PRI
access. Initiate to Hospital network sockets
establish necessary operational at installation point in
amount of IP time
addresses at
installation time.
9. Make an Operators are available for
appointment with training at date.
- PRI
the radiologist for
operator training.
10. If applicable make Hospital technician available and
an appointment with prepared to perform mounting of
the hospital earthquake kit during installation. - PRI
technician to mount
the earthquake kit.
11. Make an Knowing where the device will
appointment with arrive.
the hospital
Knowing the transport path; - PRI
technician to define
clarifying eventual needs for
delivery and
transportation means.
transport path.
12. Compare the Environmental conditions at the
required ambient installation location complies
and climatic with the operation conditions of
8.6 PRI
conditions with the the digitizer.
condition at the
installation place.
13. Make an To be able to initiate all required
appointment with prerequisites in advance to allow
the house electrician proper electrical connections.
or the authorized
6 PRI
electrician and
check the required
electrical
connection.
14. Check the To be sure that all required pre-
installation installation conditions are
10.2 PRI
readiness during fulfilled.
follow up visit.

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10.2 Installation Readiness Checklist

In order to guarantee an effective and smooth installation process within the targeted
time frame, the following tasks of the checklist below must be carried out prior to the
installation of the device.

Check and discuss all the required measures for the installation by means of this
checklist. Remarks on the individual items can be noted on the back of the list.

For Agfa employees only:


After completion hand out this checklist to your local Agfa representative.

Name of Field
Service Engineer: Checking date:

Client name:

Client address:

Contact person,
name and title:

Client phone
number: Extension:

Order / OGT*
Type of systems: number:

* OGT = Order Generation Tool, only applicable for Agfa employees

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Task OK Task code*


OGT = Order Generation Tool, only applicable for
Agfa employees

Installation date scheduled with the customer. PRI**


Tasks of Installation Planning Checklist performed
successfully.
PRI**
Details see section 10.1:
Installation Planning Checklist
Installation Site ready for Installation -
* Task Code, only applicable for Agfa employees
** PRI = Pre-Installation

Remarks:

Signature of Field Service Engineer: _______________________________________

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HEALTHCARE
Imaging Services Generic Safety Directions
Document No: DD+DIS238.06E

Generic Safety Directions


for HealthCare Imaging Products

► Purpose of this Document

This Generic Safety Directions document comprises the general safety relevant information including
relevant environmental and occupational safety instructions for the Service Engineer.
It is valid for all Agfa HealthCare Imaging Products and part of each Service Documentation as well as
Installation Planning document.
The latest version is available via MedNet, GSO Library path:
General Info => Agfa HealthCare => Publications => Service Manual

► Document History

Edition. Release Changes


Revision Date compared to previous Revision 1.2:
1.3 07-2009 • Updated table with laser classification to latest changes of the
corresponding standard. See section 3.3.
• Added section Environmental and occupational Safety Instructions.
See section 9.
• Added safety note concerning inroom installations of CR equipment
and corresponding X-ray shielding. See section 17.
• Added laser safety note and safety note concerning electrical checks
after repairs. See section 19.
• Added treatment for Lithium batteries in sections 19 and 21.
• Updated information concerning the recycling pass. See section 24.

► Referenced Documents

Document Title
Not applicable Not applicable

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Edition 1, Revision 3
07-2009 printed in Germany Document Node ID: 11849633
eq_generic_safety_directions_e_template_v01
Agfa Company Confidential Copyright © 2009 Agfa HealthCare N.V.
DD+DIS238.06E Generic Safety Directions

► Manufacturer
Agfa HealthCare N.V.

Publisher
Agfa-Gevaert HealthCare GmbH
Tegernseer Landstraße 161
D - 81539 München
Germany
Copyright © 2009 Agfa HealthCare N.V.
All rights reserved.
Technical modifications reserved.
AGFA and the Agfa-Rhombus are trademarks of Agfa HealthCare N.V.

WARNING:
Improper operation or service activities may cause damage or injuries.

INSTRUCTION:
(1) Read the "Generic Safety Directions" document
(see MEDNET GSO => General Info => Agfa HealthCare => Publications =>
Service Manual) prior to attempting any operation, repair or maintenance task on the
equipment.
(2) Strictly observe all safety directions within the "Generic Safety Directions" and on
the product.

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DD+DIS238.06E Generic Safety Directions

LIST OF CONTENTS

1 DISCLAIMER......................................................................................................... 5

2 USED ICONS ........................................................................................................ 6

3 LABELS ................................................................................................................. 7

3.1 CE Mark................................................................................................... 7
3.2 System Labels ......................................................................................... 7
3.3 System Labels concerning Laser Radiation ............................................ 8
4 PRODUCT COMPLAINTS .................................................................................. 10

5 REFERENCES .................................................................................................... 10

6 INTENDED USE.................................................................................................. 11

7 INTENDED USER ............................................................................................... 11

8 QUALIFICATIONS FOR OPERATION AND SERVICE TASKS.......................... 11

9 ENVIRONMENTAL AND OCCUPATIONAL SAFETY INSTRUCTIONS............. 12

10 CONNECTIONS TO OTHER EQUIPMENT ........................................................ 13

11 ACCESSORIES AND SPARE PARTS ................................................................ 14

12 COMPLIANCE..................................................................................................... 14

13 SAFETY DIRECTIONS FOR OPERATION......................................................... 17

14 RADIATION PROTECTION ................................................................................ 18

15 SAFETY DIRECTIONS FOR CLEANING AND DISINFECTION......................... 18

16 GENERAL SAFETY DIRECTIONS FOR SERVICE ACTIVITIES ....................... 19

17 SAFETY DIRECTIONS FOR INSTALLATION PLANNING ACTIVITIES ............ 20

18 SAFETY DIRECTIONS FOR INSTALLATION ACTIVITIES................................ 22

19 SAFETY DIRECTIONS FOR MAINTENANCE AND REPAIR ACTIVITIES ........ 23

20 SAFETY DIRECTIONS FOR REMOTE SERVICE ACTIVITIES ......................... 26


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DD+DIS238.06E Generic Safety Directions

21 SAFETY DIRECTIONS FOR TRANSPORT AND SHIPMENT OF SPARE


PARTS, ACCESSORIES AND DEVICES............................................................27

22 SAFETY DIRECTIONS CONCERNING MODIFICATIONS.................................27

23 SAFETY DIRECTIONS CONCERNING HAZARDOUS MATERIALS .................27

24 RECYCLING ........................................................................................................27

25 WASTE DISPOSAL .............................................................................................28

26 ERASING PROTECTED HEALTH INFORMATION (PHI) ...................................28

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DD+DIS238.06E Generic Safety Directions

1 Disclaimer

The installation and service of equipment described herein is to be performed by qualified


personnel who are employed by Agfa HealthCare or one of its affiliates or who are
otherwise authorized by Agfa HealthCare or one of its affiliates to provide such services.

Fitters, engineers and other persons who are not employed by or otherwise directly
affiliated with or authorized by Agfa HealthCare or one of its affiliates are directed to
contact one of the local offices of Agfa HealthCare or one of its affiliates before attempting
installation or service procedures.

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

Agfa HealthCare 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.

Agfa HealthCare shall under no circumstances be liable for any damage arising from the
use or inability to use any information, apparatus, method or process disclosed in this
document.

Agfa HealthCare is not liable for resulting consequences, damages or injuries if you don’t
operate the product correctly or if you don’t have it serviced correctly.

Agfa HealthCare reserves the right to change the product, the characteristics and its
documentation without further notice to improve reliability, function or design.

NOTE:
In the United States, Federal Law stipulates that medical devices should only be sold to,
distributed and used by or by order of a licensed physician.

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2 Used Icons

Icon Name and Circumstances


CAUTION: Possible dangerous situation: Light injuries or
damage to the equipment described in the manual and/or
damage to any other equipment or goods and/or environmental
pollution can be the consequence.
WARNING: Dangerous situation: Potential serious injury to a
user, engineer, patient or any other person and possible
mistreatment of patients can be the consequence.
DANGER: Direct, immediate danger: Death or heavy injuries
can be the consequence.

INSTRUCTION:
If used in combination with the warning or caution sign: Indicates
a specific instruction, which if followed exactly, avoids the
subject of the warning or caution.
If used without warning or caution sign: Indicates an instruction
where it is important to follow literally as described.
IMPORTANT:
Highlights very important actions which have to be carried out to
prevent malfunction.
NOTE:
Indicates advice to facilitate the following step or action.
Highlights unusual points.
Indicates background information.
Can be used to explain or highlight displays of the
graphical user interface.
Is additional information without influence on the action or step!

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3 Labels

3.1 CE Mark

CE Mark This product carries the CE Mark. The CE Declaration (CE Conformity)
becomes invalid if the product is changed without explicit consent of the
manufacturer! This applies to all parts, not only to safety elements.

3.2 System Labels

All system labels and software version number locations are referred to within this service
document in the appropriate section.
Enclosed an overview of common labels, according to ISO 3864.
This list is not complete.

Hot Surface Laser Beam Magnetic Field Ionizing Radiation

Obstacles Corrosive Liquid High Voltage Hand Injuries


C&W_005.cdr

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3.3 System Labels concerning Laser Radiation

According to its classification, laser radiation can lead to eye and skin injuries.
Each laser source is classified from class 1 to class 4, based on standard
DIN EN 60825-1:2007.
The table below lists the meaning of the different laser classes. Note the detailed
instructions in the user manual and technical documentation.

Class # Meaning Example Label

Class 1: Not dangerous to the human eye, even


when using optical instruments. Can
nevertheless produce irritating effects, CLASS 1 LASER PRODUCT
especially with low ambient light
conditions.

Class 1 M: Not dangerous to the human eye if no


optical instruments (magnifying glass or LASER RADIATION
binocular) are used. DO NOT VIEW DIRECTLY WITH
Can nevertheless produce irritating OPTICAL INSTRUMENTS

effects, especially with low ambient light CLASS 1M LASER PRODUCT

conditions.

Class 2: Dangerous to the human eye for


intentional staring into the beam.
Not dangerous for short term exposure
< 0,25 seconds.
Using optical instruments does not
increase the risk of eye injury. LASER RADIATION
Can even for short term exposure < 0,25
seconds produce dazzling and irritating DO NOT STARE INTO BEAM

effects, especially with low ambient light CLASS 2 LASER PRODUCT


conditions.

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Class # Meaning Example Label

Class 2M: Dangerous to the human eye when


staring into the beam or when using
optical instruments (magnifying glass or
telescope). No hazard for short term
exposure < 0,25 seconds (aversion
response of the eye) without use of LASER RADIATION
optical instruments. Can produce DO NOT STARE INTO THE BEAM
dazzling and irritating effects even for OR VIEW DIRECTLY WITH
OPTICAL INSTRUMENTS
short term exposure < 0,25 seconds, CLASS 2M LASER PRODUCT
especially at low ambient light conditions.

Class 3R: Possibly dangerous to the human eye for


direct view into the beam.
Risks of an eye injury is increasing with
duration of exposure.
Can produce dazzling and irritating
effects, especially with low ambient light LASER RADIATION
conditions.
AVOID DIRECT EYE EXPOSURE

CLASS 3R LASER PRODUCT

Class 3B: Normally dangerous to the human eye


for direct view into the beam.
Viewing diffuse reflections is normally not
dangerous.
Risk of small skin injuries or ignition of
explosive material if the power of the LASER RADIATION
laser beam is close to the upper limits of
class 3 B. AVOID EXPOSURE TO BEAM

CLASS 3B LASER PRODUCT

Class 4: Dangerous to the human eye for direct


view into the beam or viewing diffuse
reflections.
Very often class 4 lasers also implicate a
fire hazard.
LASER RADIATION
AVOID EYE OR SKIN EXPOSURE
TO DIRECT OR SCATTERED
RADIATION
CLASS 4 LASER PRODUCT

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4 Product Complaints

Any service person who has any complaints or has experienced any dissatisfaction in the
quality, durability, reliability, safety, effectiveness or performance of this product must
notify Agfa HealthCare by the Agfa HealthCare complaint procedure.
If the product malfunctions and may have caused or contributed to a serious injury of a
patient or an accident or if there are any hazards which may cause an accident
Agfa HealthCare must be notified immediately by telephone, fax or written
correspondence to the following address:
Agfa Service Support - local support addresses and phone numbers listed on:
www.agfa.com

Agfa – Gevaert N.V.


Septestraat 27
2640 Mortsel, Belgium.
Fax +32 3 444 4485

5 References

Technical Documentation is available via MedNet (PDF) and your local Agfa HealthCare
support organisation (Paper).

Access to MedNet:
IntraNet: http://docs.agfanet/bu/mi/mednet/mednetcso.nsf
ExtraNet: http://extranet.agfa.com/bu/mi/mednet/mednetcso.nsf

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6 Intended Use

This Agfa HealthCare product should only be operated in a hospital or clinical radiological
environment by qualified staff.
It must only be operated according to its specifications and its intended use. Any
operation not corresponding to the specifications or intended use may result in hazards,
which in turn may lead to serious injuries or fatal accidents (for example electric shocks).
AGFA will not assume any liability whatsoever in these cases.
Make sure that the product is constantly monitored in order to avoid inappropriate
handling, especially by children.
The product must only be installed and put into operation under the specified conditions.

7 Intended User

This manual is written for Agfa trained Field Service Engineers and Clinical Application
Specialists, trained users of Agfa HealthCare products and trained diagnostic X–Ray
clinical personnel who have received proper training. Users are considered as the persons
who handle the equipment as well as the persons having authority over the equipment.

8 Qualifications for Operation and Service Tasks

This Technical Documentation describes adjustments and routines which must only to be
performed by qualified technical personnel.
The Agfa (trained) Field Service Engineers and Clinical Application Specialists must have
received adequate Agfa HealthCare training on the safe and effective use of the product
and applicable environmental and occupational safety matters before attempting to work
with it. Training requirements may vary from country to country.
Agfa (trained) Field Service Engineers and Clinical Application Specialists must make
sure that training is received in accordance with local laws or regulations that have the
force of law.
Your local Agfa HealthCare representative can provide further information on training.

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9 Environmental and occupational Safety Instructions

Each Agfa (trained) Field Service Engineer and Clinical Application Specialist:

• Must make his or her personal contribution to improve safety and protect the
environment.
• When working on a customers site, has a duty to take reasonable care to avoid injury
to himself or herself or to others who may be affected by their acts or omissions.
• Is obligated to adhere strictly to regulations and instructions.
• Shall familiarise himself or herself with the provisions of the Agfa Healthcare
Health, Safety and Environment Policy and any specific rules or procedures relating to
occupational safety at work and the protection of the environment.
• Shall promptly report any near misses, accidents, incidents or dangerous occurrences
to their line manager and co-operate fully in any investigation.
• Shall co-operate with company management on matters relating to
health, safety and environment and, where appropriate, discuss with and / or assist
their manager in resolving matters relating to health, safety and environment.
• Shall ensure that any company equipment issued to them, or, for which they are
responsible, is correctly used and properly maintained.
• Shall wear protective equipment whenever instructed or if it is recommended to do so.
• Shall be responsible for good housekeeping in the area in which he or she is working.
• Shall report situations, which could put them at risk, on either company or
customers' premises, to their manager or supervisor; and, if warranted, directly and in
confidence, to the Health and Safety Co-ordinator, Global HSE Manager, or ultimately
to the Managing Director.
• Shall report any injuries, diseases or dangerous occurrences to his or her line
manager.
• Shall report any accidents, incidents or near misses to his or her line manager.
• Shall report any situation of which he or she is aware that is potentially dangerous.
• Shall comply with any health surveillance procedure instituted for his or her benefit or
for compliance with regulations.

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10 Connections to other Equipment

Agfa HealthCare equipment must only be used in combination with other Agfa HealthCare
equipment or components if these are expressly recognized by Agfa HealthCare as
compatible. A list of such equipment and components is available from Agfa HealthCare
service on request.
Changes or additions to the equipment must only be carried out by persons authorized to
do so by Agfa HealthCare. 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.
The Agfa HealthCare products are designed to communicate with other devices in the
hospital network using DICOM protocols.

Connections to other equipment:


Warning:
Accessory equipment not complying with the safety requirements of this product
may lead to a safety hazard.

INSTRUCTION:
Consult the Technical Documentation before making any connections to other equipment.
Consideration relating to the choice of accessory equipment shall include:
• Use of the accessory equipment in the patient vicinity.
• Evidence that the safety certification of the accessory equipment has been performed
in accordance with the appropriate IEC 60601-1 and IEC 60601-1-1 harmonized
national standard.
In addition all configurations must comply with the medical electrical systems standard IEC
60601-1-1. The party that makes the connections acts as system Configurer and is
responsible for complying with the systems standard.
If required, contact your local service organization.

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11 Accessories and Spare Parts

Parts and accessories replacement:


WARNING:
Hazards may be introduced because of component failure or improper operation.

INSTRUCTION:
• Replace defective parts with Agfa HealthCare original spare parts.
• Use only tools and measuring instruments which are suitable for the procedure.
• Only approved Agfa HealthCare accessories must be used. For a list of compatible
accessories contact your local Agfa HealthCare organization or www.agfa.com.

12 Compliance

Directive for HealthCare Imaging Products:


Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
(OJ No L 169/1 of 1993-07-12)

• ANNEX I - ESSENTIAL REQUIREMENTS - GENERAL REQUIREMENTS The


products are designed and manufactured in such a way that, when used under the
conditions and for the purposes intended and, where applicable, by virtue of the
technical knowledge, experience, education or training of intended users, they will not
compromise the clinical condition or the safety of patients, or the safety and health of
users.

• ANNEX II - EC DECLARATION OF CONFORMITY: Full quality assurance system


ISO 13485

• ANNEX X - CLINICAL EVALUATION: The clinical evaluation follows a defined and


methodologically sound procedure.

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Applied Standards for HealthCare Imaging Products

• IEC 60601-1, Ed. 3: Medical electrical equipment - Part 1: General requirements for
basic safety and essential performance

• ISO 14971:2000, Medical devices – Application of risk management to medical devices

• IEC 60601-1-2, It specifies the MANUFACTURER of the ME EQUIPMENT or ME


SYSTEM provides information to the RESPONSIBLE ORGANIZATION that is essential
in determining the suitability of the ME EQUIPMENT or ME SYSTEM for the
electromagnetic environment of use, and in managing the electromagnetic environment
of use to permit the ME EQUIPMENT or ME SYSTEM to maintain BASIC SAFETY and
provide its ESSENTIAL PERFORMANCE without disturbing other equipment.

Additional standards for documentation:

IEC 62079 Ed. 1: Preparation of instructions - Structuring, content and presentation

Harmonization:

Global Harmonization Task Force (GHTF) www.ghtf.org/

This document has been prepared to comply with Study Group 1 guidance document
of the Global Harmonization Task Force (GHTF) www.ghtf.org/ to assist development
of a consistent, harmonized definition for a medical device that could be used within a
global regulatory model and would offer significant benefits to the manufacturer, user,
patient or consumer, and to Regulatory Authorities and support global convergence of
regulatory systems.

IECEE CB SCHEME

The IECEE CB (Certification Body) Scheme is the world's first truly international system
for acceptance of test reports dealing with the safety of electrical and electronic products.
It is a multilateral agreement among participating countries and certification organizations.
Agfa has produced a CB test report and claims national certification in all other member
countries of the CB Scheme.

Details see www.iecee.org

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Radiation of radio frequency:


CAUTION: For USA only:
This equipment generates, uses and can radiate radio frequency energy and, if not
installed and used in accordance with the service manual, may cause interference
to radio communication.

Note:
This product has been tested and found to comply with the limits for a Class A
computing device pursuant to Subpart B of Part 15 of FCC Rules, which are designed to
provide reasonable protection against such interference when operated in a commercial
environment.
Operation of this equipment in a residential area is likely to cause interference.
The user will be required to take all necessary measures to correct the interference at
his own expense.

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13 Safety Directions for Operation

Accessibility of the mains power switch:


CAUTION:
Do not obstruct the mains power switch.
Position the Agfa HealthCare product so that it is possible to disconnect the mains power
connection.

• Under certain conditions the Agfa HealthCare product will show a display containing a
message. This message will show that either a problem or action has occurred or that
a requested action is required or cannot be performed. The user must read these
messages carefully they will provide information on what to do. This will be either
performing an action to resolve the problem or to contact the Agfa HealthCare
service organization. Details on the contents of messages can be found in this
Technical Documentation.
• All images created using any image technology can show artifacts which could be
confused with diagnostic information. If there is any doubt that the diagnostic
information could be corrupted, additional investigations must be performed to get
clear diagnostic information.
• Ventilation openings must not be covered.
• If you notice conspicuous noise or smoke, disconnect the product immediately from
the mains.
• Do not pour water or any other liquid over the device.
• If a system malfunction causes an emergency situation involving the patient, operating
personnel or any system component, activate the emergency stop for the system
concerned. All motor driven system movements will be stopped.
• Do not store any magnetic media near or on devices, which produce magnetic fields,
since stored data may be lost.

Explosive environment:
DANGER:
Risk of explosion.
Never operate this device in zones where there are flammable anesthetics or oxygen which
may cause an explosion.

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Usage of an un-interruptible power supply:


Warning:
Images can be lost due to power failure.
Connect the equipment to an un-interruptible power supply (UPS) or an institutional
standby generator.

14 Radiation Protection

Only qualified and authorized personnel shall operate any X-Ray system. In this context
qualified means those legally permitted to operate this X-Ray equipment in the jurisdiction
in which the X-Ray equipment is being used, and authorized means those authorized by
the authority controlling the use of the X-Ray equipment. Full use must be made of all
radiation protection features, devices, systems, procedures and accessories.

Ionizing radiation can lead to radiation injuries if handled incorrectly. When radiation is
applied, the required protective measures must be complied with.

15 Safety Directions for Cleaning and Disinfection

• Details about cleaning and disinfection or sterilization methods that may be used on
SYSTEM parts or ACCESSORIES that can become contaminated through contact
with the PATIENT or with body fluids, are referred to within the individual service
documents.
• Disconnect the power supply from the equipment prior to cleaning the equipment.

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16 General Safety Directions for Service Activities

• This system uses high voltage. Please consider the respective safety regulations.
• Electrical repairs and connections must only be performed by a qualified electrician.
• Mechanical repairs and connections must only be performed by a qualified technician.
• The safety directions for operation (see section 13) are also valid for all service
activities.
• During all service activities observe prescribed local and country-specific
requirements (e.g. occupational safety and accident prevention regulations).
• All existing screw connections must be tightened sufficiently firmly, but they may not
be overstressed when tightening. There must always be compliance with stated
torque values!
• Damaged or missing screws may be replaced only with the same screw types that
have the specified hardness rating. Unless a different value is listed in the
instructions, all Allen screws used must be hardness rated 8.8.
• All screws must be secured in accordance with the corresponding data.
If "Loctite" has to be used to secure screws, this is stated in the text.
• Any Agfa service PC or tool which is to be connected via RS232, RJ45, USB or other
interface to an Agfa device must not be connected to the mains but must be operated
on its internal battery or indirect supply (low voltage).

• When handling printed circuit boards (abbr.: PCBs) the following points must be
observed:
o Always switch off the equipment and unplug the power cord, before you
disconnect or connect cables on printed circuit boards.
o When working on PCBs, always wear an anti-static wrist strap. Never touch any
parts or components on PCBs with your bare fingers.
o PCBs have to be kept or transported in their protection bags. Never carry a
PCB without protection bag and walk on carpet or plastic floor covering
(electrostatic charge).
o Once the PCB is taken out of its protection bag, it has to be protected from
electrostatic charge by a grounded mat.

Static discharge at electrical components:


CAUTION:
Static discharge! Electrical components may be destroyed:
For the repair on electrical components, wear a grounding strap
(Order number: CM+9 9999 0830 0) around the wrist and connect the other end of this
strap on a grounded conducting metal piece.

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17 Safety Directions for Installation Planning Activities

Protecting CR (Computed Radiography) Equipment against scattered X-Rays:


Warning:
Image plate is sensitive for X-rays. Poor image quality possible.

The digitizer and the cassette storage shall be protected against X-ray radiation this way,
that the annual dose equivalent at the installation place will not exceed 1 mSv.

Protecting Film-Screen Systems against scattered X-Rays:


Warning:
Film is sensitive for X-rays. Poor image quality possible.

The film-screen system shall be protected against X-ray radiation this way, that the annual
dose equivalent at the installation place will not exceed 1 mSv.

Accessibility of the power disconnection device:


Warning:
Electrical device. Shock possible.

INSTRUCTION:

• Do not position Agfa EQUIPMENT so it is difficult to operate the disconnection device


when an APPLIANCE COUPLER or separable plug is used as isolation.
• Local and International wiring regulations must be observed. Check all supplies and
voltages, currents, trips and fuses with the Hospital facilities department or their
engineers.

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• The device complies with the EN 60601-1, 2006 standard for Information Technology.
This means that, although it is absolutely safe, patients may not come in direct contact
with the equipment. Therefore the operator console must be placed outside a radius
of 1.5 m around the patient.

R = 1.5m

1.5m
1.5m

Patient environment

• This device should be installed behind the institution firewall for network security and
anti-virus protection. No ongoing computer virus protection or network security for this
medical device is provided (e.g. a computer firewall). Network security and anti-virus
provisions are the ongoing responsibility of the user or institution.

Fixing equipment at the wall or floor:


Warning:
Unknown composition of wall or floor structure: Risk of injury or damage:
Hospital management is responsible for the position, location and fixing of all equipment.

Floor load:
CAUTION:
Heavy device may damage the floor covering.
Make sure that the floor covering is solid enough to stand the weight of the device.

Fixing equipment at the ceiling:


CAUTION:
Ceiling construction may be inadequate for fixing of equipment: Risk of injury or
damage:
Hospital management is responsible for the position, location and fixing of all equipment.

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18 Safety Directions for Installation Activities

• If not otherwise stated, installation and configuration is performed by Agfa HealthCare


trained personnel.
• If damage of the package is visible from the outside contact your local AGFA
representative.
• Apart from wearing the required protective clothing, e.g. safety boots and gloves, care
must be taken that heavy loads are correctly lifted/carried to avoid injury. The relevant
instructions must be complied with. Heavy or awkward loads must be moved by
mechanical means or by several people.
• When installing the product be sure that there is either a mains plug or an all-cable
disconnecting device in the internal installation fitted near the product and that it is
easily accessible.
• Defective covers, sharp edges or protruding parts of equipment can cause injuries, if
accidentally knocked into. Route cables and position equipment safely.
• This device should be installed behind the institution firewall for network security and
anti-virus protection. No ongoing computer virus protection or network security for this
medical device is provided (e.g., a computer firewall). Network security and anti-virus
provisions are the ongoing responsibility of the user or institution.

Connection of the device to the power supply:


CAUTION:
Risk of damaging the device by using the wrong power supply:

INSTRUCTION:
Prior to connecting the device to the mains:
• Compare the power requirements indicated on the type label with the available
power supply in the installation room.
• Check the service manual for the type of input voltage selection, manual or
automatic: If manual, select the appropriate voltage and fuses.
• Confirm to use the correct socket and plug for the required power supply.
• Check the equipment will work with the power supply available.

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Ground potential differences:


CAUTION:
To comply with ISO 60601-1 (annex I) all computers and peripherals must be
connected to the same power source.

INSTRUCTION:
• Always connect the associated monitor to the same Uninterruptible Power Source as
the PC.
• When different combinations of equipment are used in various medical environments
a potential difference (V) can exist between the protective earths in different localities.
If the protective earthing fails this potential difference can cause a HAZARD for the
OPERATOR or for the PATIENT.

19 Safety Directions for Maintenance and Repair Activities

• This Technical Documentation identifies the parts on which preventive inspection and
maintenance shall be performed by Agfa HealthCare service personnel, including the
periods to be applied.
• In general the device has to be switched off during service activities. Exception: If the
device is switched on to perform tests pay particular attention to any hazards due to
moving and rotating parts. Avoid lose clothing or finger traps. Switch off the device
immediately after the tests.
• Do not turn motors manually. If required, first disconnect the motor from the motor
control board.
• Make sure that the power cord does not show any signs of damage.
• After repair work always check that the integrated safety features are not overridden
or disconnected.
• If there is any visible damage to the machine casing do not hand-over the product to
the customer. First repair the machine casing.

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Replacing batteries:
WARNING:
Battery can explode, causing chemical burns.

INSTRUCTION:

• Check that batteries are inserted with correct polarity.


• Only use batteries of the same type or an equivalent type as specified by the
manufacturer.
• Dispose of empty batteries in compliance with the specifications of the manufacturer.
• When removing lithium batteries from the equipment take appropriate measures to
avoid short circuit of the battery:
Either use tape to cover the two poles of the battery or put the battery back in its
original packing and secure the packing by tape.

Performing the electrical test according to national regulations:


WARNING:
Improper ground connections inside the device or too high leakage current may lead to
electric shocks.
• After any work at the power supply or at any component connected to mains voltage
inform the responsible organization 1 about the necessity of the electrical test
according to national regulations.
If specific national regulations do not exist: It is recommended to perform the
electrical test according to IEC 62353.
• Make sure, that all grounding connections to metallic covers and all grounding
connections inside the device are present.

NOTE:
On MedNet, GSO Library path "General Info => Agfa HealthCare => Publications =>
Service Manual" a form “IEC 62353:2007 Test Documentation” for CR Digitizers is
available, to be handed out to the responsible organization (Intranet Link / Extranet Link).

1
Responsible Organization:
Entity accountable for the use and maintenance of a medical equipment or a medical equipment system. The
accountable entity can be, for example, a hospital or an individual clinician.
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Performing service activities at devices emitting laser radiation:


WARNING:
Laser radiation. Eye injury possible.

INSTRUCTION:

• Strictly observe the warning notes in the service manual of devices emitting laser
radiation (See service manual chapter describing Safety Guidelines / General
Repair Instructions) and at the corresponding steps of instructions.
• Strictly observe the warning labels at the modules emitting laser light. For the
meaning of the labels refer to section 3.3 in this document.
• Do not look into the laser beam.
• Do not open modules containing a laser. Only open modules containing a laser if
explicitly instructed to do so.
• Do not keep tools in the laser beam unless explicitly instructed to do so.
• Make yourself familiar with the path of the laser light and the conditions, when the
laser beam is switched on. Refer to the Functional Description in the
corresponding service manual.
• Do not operate modules with laser outside the device.

Sharp edges:
CAUTION:
Sharp edges inside the device: Cut or abrasion possible.
Be careful at maintenance and replacement of parts.

Cleaning optical elements:


CAUTION:
Image artifacts possible after cleaning optical elements.
When cleaning optical elements follow the service manual precisely.

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Secured screws:
CAUTION:
Opening screws secured by red lacquer may misalign important device
adjustments:
Do not open screws that are secured by red lacquer.

Opening PCs and Workstations:


Warning:
Electrical shock and damage to the equipment possible.
• Only open the PC or workstation if explicitly stated in the service manual.
• Unplug before opening.
• Observe anti-static safety regulations.

Replacing fuses:
Warning:
Replacing fuses by wrong type may lead to fire hazard!
Use only fuses of the exact value and characteristics stated in the service manual or on
the device.

20 Safety Directions for remote Service Activities

Remote Service Activities:


Warning:
During remote service activities images can be lost.
Inform the customer prior to remote service activities to finish the current work and to
stop working on the system.

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21 Safety Directions for Transport and Shipment of Spare Parts,


Accessories and Devices

• In compliance with transport regulations, all uninterruptible power supplies (UPS)


must be shipped with batteries disconnected.
• Use the original packing when returning spare parts, accessories or devices.
• Before returning any spare part with a built in lithium battery remove it and dispose the
batteries locally according to local waste regulations.

22 Safety Directions concerning Modifications

Modifications made in products/systems shipped by Agfa HealthCare must not be


implemented without written permission from Agfa HealthCare.
This applies in particular to changes which may affect the mechanical and/or electrical
safety or radiation-protection properties of a product (e.g. changing of safety distances,
removal of locks/instructions etc.).

23 Safety Directions concerning Hazardous Materials

'Hazardous materials' is the designation for substances which can ignite or explode or
which are toxic, injurious to health, corrosive or irritating. The “Hazardous Material”
instructions must be read and the required protective measures must be complied with
when performing work to avoid health risks.
Their properties together with the hazards and protective measures connected with them
are identified clearly by symbols and described by the instructions appertaining to the
hazardous substances.

24 Recycling

Agfa HealthCare has Recycling Passports available for all equipment. The Recycling
Passport explains whether hazardous materials, special components and batteries are
present, where they are located and how they can be removed at the end of the life cycle.

The Recycling Passports are meant to be used as information for waste treatment
partners and companies that want to recycle end-of-life Agfa equipment.

To get a copy of the required Agfa HealthCare Recycling Passport please contact your
local Sales organization.

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25 Waste Disposal

On August 13, 2005, the European Directive on Waste Electrical and


Electronic Equipment (WEEE) 2002/96/EC, amended by Directive
2003/108/EC, came into force.

The directive on Waste Electrical and Electronic Equipment (WEEE) aims to


prevent the generation of electric and electronic waste and to promote the
reuse, recycling and other forms of recovery. It therefore requires the collection
of WEEE, recovery and reuse or recycling.
This directive has to be implemented into national law by the individual
European countries by August 13th 2005.

Due to the implementation into national law, specific requirements can be


different within the European Member States.
This symbol on the product, or in the manual and in the warranty, and / or on
its packaging indicates that this product shall not be treated as household
waste.
For more detailed information about take-back and recycling of this product,
please contact your local Agfa service organization. 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.
If your equipment or replaced spare parts contain batteries or accumulators
please dispose of these separately according to local regulations.

26 Erasing Protected Health Information (PHI)

AGFA HealthCare Field Service Personnel or its authorized affiliates are responsible for
the removal of Protected Health Information (PHI) patient data from devices, modules or
parts that are removed from the customer’s site. This also applies to the exchange of
spare parts, especially to parts that are returned to central warehouses for repair or
refurbishing. Examples for parts or modules that may contain Protected Health
Information (PHI) are: Computer hard disks, CD-ROMS, backup tapes, archive tapes.

DOCUMENT CONTROL NOTE:


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Edition 1, Revision 3 Generic Safety Directions for HealthCare Imaging Products Page 28 of 28
07-2009 Agfa Company Confidential
Chapter 1
HEALTHCARE Controls, Connections,
Imaging Services
and Setup Procedures
Document No: DD+DIS230.10E

CR 30-X 2nd
Type 5175 / 200 / 205 / 220 / 225

CR 30-Xm
Type 5179 / 100

► Purpose of this Document

This document describes:


 All important routines to be carried out prior to putting the machine in operation
 Location and function of the controls and connectors of the machine
 All routines necessary to put an unpacked machine in operation

► Document History

Edition. Release Changes


Revision Date compared to previous version 1.3
1.4 02-2012 Added Mammography specific items for CR 30-Xm.

► Referenced Documents

Document Title
DD+DIS229.10E CR 30-X 2nd / CR 30-Xm Service Manual,
Chapter 11 - Installation Planning
DD+DIS230.10E CR 30-X 2nd / CR 30-Xm Service Manual,
Chapter 3.2 - Tools and auxiliary means
DD+DIS055.11E NX workstation Service Manual,
Chapter 4 - Installation and Configuration
DD+DIS283.11E Service Manual: CR Mammography Solution based on
CR30-Xm

DOCUMENT CONTROL NOTE:


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Edition 1, Revision 4
02-2012 Printed in Germany Document Node ID: 30878384
eq_01_setup_procedure_e_template_v08
Agfa Company Confidential Copyright © 2012 Agfa HealthCare N.V.
DD+DIS230.10E Controls, Connections, and Setup Procedures

► Manufacturer
Agfa HealthCare N.V.

Published by
Agfa-Gevaert HealthCare GmbH
Tegernseer Landstraße 161
D - 81539 München
Germany
Copyright  2012 Agfa HealthCare N.V.
All rights reserved.
Technical modifications reserved.
Agfa and the Agfa rhombus are trademarks of Agfa-Gevaert N.V., Belgium,
or its affiliates.

WARNING:
Improper operation or service activities may cause damage or injuries.

INSTRUCTION:
(1) Read the "Generic Safety Directions" document
(see Agfa HealthCare Library > General Info > Agfa HealthCare > Publications >
Service Manual) prior to attempting any operation, repair or maintenance task on
the equipment.
(2) Strictly observe all safety directions within the "Generic Safety Directions" and on
the product.

IMPORTANT:
The installation and service of the product(s) described herein is to be performed
by qualified personnel who are employed by Agfa HealthCare or one of its affiliates
or who are otherwise authorized by Agfa HealthCare or one of its affiliates to provide
such services.

NOTE:
To verify the latest version of a chapter of the Service Manual refer to the “Checklist for
Completeness” in the Agfa HealthCare Library.

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Edition 1, Revision 4 CR 30-X 2nd, Type 5175 / 200 / 205 / 220 / 225 Chapter 1 / Page 2 of 39
02-2012 CR 30-Xm, Type 5179 / 100 Agfa Company Confidential
DD+DIS230.10E Controls, Connections, and Setup Procedures

LIST OF CONTENTS

1 INSTALLATION PREPARATION .............................................................................................4


1.1 Checking Installation Site Prerequisites ...................................................................................4

1.2 Preparing the required Tools ....................................................................................................5

1.3 Unpacking the Digitizer .............................................................................................................6

1.4 Checking the Shipment Completeness.....................................................................................8

2 CONNECTING THE DIGITIZER TO THE NX WORKSTATION...............................................9


2.1 Connecting the Cables..............................................................................................................9

2.2 Switching on the Digitizer and NX Workstation ......................................................................11

2.3 Taking out the Digitizer USB Flash Drive ...............................................................................12

2.4 Installation of the Error Viewer on the NX Workstation ..........................................................14

2.5 Configuring the NX Workstation with Default Settings ...........................................................14

2.6 Testing Standalone Installation...............................................................................................19

2.7 Filling in Site specific Data ......................................................................................................20

2.8 Checking Software Version.....................................................................................................20

2.9 Configuring the Maintenance Indicator (Optional) ..................................................................21

3 CONFIGURING THE DIGITIZER AND THE NX WORKSTATION FOR THE HOSPITAL


NETWORK .............................................................................................................................22
3.1 Adapting the Local Settings and Network Settings at the Digitizer.........................................22

3.2 Adapting the Communication Parameters at the Workstation................................................22

3.3 Creating CPF File and Loading it to the Digitizer....................................................................23

4 COMPLETION OF INSTALLATION .......................................................................................25


4.1 Checking the Technical Image Quality of the System ............................................................25

4.2 Confirming the Installation Date of the Digitizer......................................................................32

4.3 Performing a Backup ..............................................................................................................33

4.4 Storing the USB Flash Drive ...................................................................................................34

4.5 Hand-over of the System to the Clinical Application Specialist ..............................................34

5 INSTALLATION CHECKLIST .................................................................................................38

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Edition 1, Revision 4 CR 30-X 2nd, Type 5175 / 200 / 205 / 220 / 225 Chapter 1 / Page 3 of 39
02-2012 CR 30-Xm, Type 5179 / 100 Agfa Company Confidential
DD+DIS230.10E Controls, Connections, and Setup Procedures

1 Installation Preparation

This document describes the installation and configuration of the digitizer.

NOTE:
For the installation and configuration of the NX Workstation. refer to Chapter 4 of the
corresponding NX Workstation version in the Agfa HealthCare Library:
Computed Radiography  CR Workstation Software
CR 30-X 2nd is only supported as of NX 2.0.8500 / 3.0.8500.
CR 30-Xm is only supported as of NX 2.0.8600 / 3.0.8600.

For installation instructions of optional digitizer components like “All-in-one Cart”,


UPS or Mobile Kit refer to the accompanying document of the option.

The Installation Checklist in section 5 of this chapter gives an overview of all steps
of the digitizer installation and guides through the complete installation process.

The task overview for preparing installation is listed in following table:

# Task Overview Section


1 Checking installation site prerequisites 1.1
2 Preparing required tools. 1.2
3 Unpacking the digitizer 1.3
4 Checking the shipment completeness 1.4

1.1 Checking Installation Site Prerequisites

REQUIRED TIME:
Approximately 15 minutes

(1) Confirm that all prerequisites described in the "Installation readiness checklist"
are fulfilled.

Refer to the checklist in CR 30-X 2nd / CR 30-Xm Service Manual chapter 11,
Installation Planning.

DOCUMENT CONTROL NOTE:


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Edition 1, Revision 4 CR 30-X 2nd, Type 5175 / 200 / 205 / 220 / 225 Chapter 1 / Page 4 of 39
02-2012 CR 30-Xm, Type 5179 / 100 Agfa Company Confidential
DD+DIS230.10E Controls, Connections, and Setup Procedures

(2) Download the following documents from the Agfa HealthCare Library before
starting with the installation:
 Solution Structure Data Document, Document ID* 30781759
(Intranet Link / Extranet Link)
 CR/DR Interoperability Matrix, Document ID* 31333326,
(Intranet Link / Extranet Link)
(3) Check before installation, if all system components with their hardware and
software versions are compatible to each other.

1.2 Preparing the required Tools

Part of digitizer delivery

Torx Key TX20


USB Flash Drive
1,5 mm Copper Filter Spare part number*:
Spare part number*: CM+6037431 (CR 30-X 2nd)
CM+9 5155 1015 2 CM+6045180 (CR 30-Xm) Torx Key TX45

2 mm Al Filter (CR 30-Xm only) Limit Pattern CD ROM Limit Pattern CD ROM
Spare part number*: (CR 30-X 2nd only) (CR 30-Xm only)
CM+9 5148 1090 0 Spare part number*: Spare part number*:
CM+9 5175 9160 0 CM+6049480

Not part of digitizer delivery

Polynit wipes CR Phosphor Plate Cleaner


Spare Part Number*: Spare part number*:
Lint free cloth cutter 10+9 9999 1273 0 10+9 9999 1197 0

* The last digit in the spare part number indicates the spare part revision at release of this document.
When ordering, the actual revision of the spare part is delivered.

NOTE:
For connection of CR 30-Xm to NX with software version 2.0.8600 / 3.0.8600 the
CR 30-Xm digitizer model file is required. Download the CR 30-Xm model file from the
Agfa HealthCare Library:
Computed Radiography > CR Digitizers > CR 30-X 2nd / CR 30-Xm

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Edition 1, Revision 4 CR 30-X 2nd, Type 5175 / 200 / 205 / 220 / 225 Chapter 1 / Page 5 of 39
02-2012 CR 30-Xm, Type 5179 / 100 Agfa Company Confidential
DD+DIS230.10E Controls, Connections, and Setup Procedures

1.3 Unpacking the Digitizer

REQUIRED TIME:
Approximately 5 minutes

(1) Compare the labels on the boxes with the customers order list and the
shipping papers.
(2) Check the packing material for visible transport damage such as:
 Dented edges
 Damage on the box
 Torn fixing elements (metal straps)
(3) Check the attached safety indicators on the packing boxes.

IMPORTANT: White field is OK.


If the device was tilted, the circle in the Red field is not OK.
arrow head of the TILTWATCH changes
from white to red. STOSSEMPFINDLICH

If the device was subjected to shocks, the


square field in the middle of the
SHOCKWATCH changes from white to
red.
Figure 1

 If damages are visible from the outside, inform the carrier. The damage must be
noted down in the handover documents.
 If the device should be replaced, contact your local AGFA representative.
 If no damage is visible from the outside start installation.

(4) Unpack the digitizer. The unpacking


instructions are printed on the
digitizer box.
Figure 2 shows an example of the
unpacking instructions.

Figure 2

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Edition 1, Revision 4 CR 30-X 2nd, Type 5175 / 200 / 205 / 220 / 225 Chapter 1 / Page 6 of 39
02-2012 CR 30-Xm, Type 5179 / 100 Agfa Company Confidential
DD+DIS230.10E Controls, Connections, and Setup Procedures

WARNING:
The digitizer is heavy (72.5 kg; 159.8 lb). Risk of injuries when lifting the digitizer.
 At least two persons have to lift the digitizer from one position to the other.
 When removing scanner only one person is needed to lift the digitizer from one
position to the other.
 Use proper foot and hand protection when lifting the digitizer.
 Lift the digitizer from the sides only. Do not lift at the feed table.

WARNING:
Excessive vibrations during scanning may decrease image quality.
The structure and stability of the used table need to be suitable in relation with the
size and weight of the system. The table may not be subject to excessive shock and
vibrations from other sources.

(5) Lift the digitizer from the pallet on the provided table.

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Edition 1, Revision 4 CR 30-X 2nd, Type 5175 / 200 / 205 / 220 / 225 Chapter 1 / Page 7 of 39
02-2012 CR 30-Xm, Type 5179 / 100 Agfa Company Confidential
DD+DIS230.10E Controls, Connections, and Setup Procedures

1.4 Checking the Shipment Completeness

(6) Compare the scope of delivery with the packing list.

Example for packing list:

Quantity Description
1 Digitizer
1 Packing list
1 Installation report
1 CE declaration of conformity
1 Installation Procedure
(Chapters 1 and 11 of the Technical Documentation)
1 Power cable, Europe 3.00 m
1 Power cable, US 3.00 m
1 Network cable 5 m / 16 feet long
1 1.5 mm CU filter
1 2 mm Al filter (CR 30-Xm only)
1 USB flash drive with Software for the digitizer
(delivered in the digitizer USB flash drive holder)
1 Torx Key TX20
1 Torx Key TX45
1 CD with limit pattern for flatfield evaluation
1 CD with User Manuals in all specified languages**

* RoHS = Restriction of the use of certain Hazardous Substances


** Language: Chinese-simplified, Chinese-traditional, Czech, Danish, Dutch, English, Finnish,
French, German, Greek, Italian, Korean, Norwegian, Polish, Portuguese, Russian, Spanish,
Swedish, Thai, Vietnamese, Estonian, Hungarian, Latvian, Lithuanian, Slovak, Slovenian, Turkish

DOCUMENT CONTROL NOTE:


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Edition 1, Revision 4 CR 30-X 2nd, Type 5175 / 200 / 205 / 220 / 225 Chapter 1 / Page 8 of 39
02-2012 CR 30-Xm, Type 5179 / 100 Agfa Company Confidential
DD+DIS230.10E Controls, Connections, and Setup Procedures

2 Connecting the Digitizer to the NX Workstation

REQUIRED TIME:
Approximately 15 minutes

This section is split up into the following steps:

# Task Overview Section


1 Connecting the cables. 2.1
2 Switching on the digitizer and NX Workstation. 2.2
3 Taking out the USB flash drive. 2.3
4 Installing the Error Viewer on the NX Workstation. 2.4
5 Configuring the NX Workstation with Default Settings. 2.5
6 Testing standalone installation. 2.6
7 Filling in site specific data. 2.7
8 Checking of the software version. 2.8
9 Configuring the maintenance indicator. 2.9

2.1 Connecting the Cables

IMPORTANT:
Do not yet connect the digitizer and NX Workstation to the hospital network.
Connecting the digitizer and the NX Workstation into the hospital network is performed
after checking the stand-alone installation of the system.

NOTE:
The digitizer is delivered with two power cables for US/Europe. If a different cable
is needed, organize it locally.

For more information refer to CR 30-X 2nd Service Manual, chapter 11, Installation
Planning.

DOCUMENT CONTROL NOTE:


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Edition 1, Revision 4 CR 30-X 2nd, Type 5175 / 200 / 205 / 220 / 225 Chapter 1 / Page 9 of 39
02-2012 CR 30-Xm, Type 5179 / 100 Agfa Company Confidential
DD+DIS230.10E Controls, Connections, and Setup Procedures

(1) Connect the mains cable.

(2) Make a direct network connection Power Supply Input


between digitizer and NX.

Network
Connector
517501ad.cdr

Figure 3

(3) Fasten the mains cable and


network cable at the corresponding
cable holder.

5175_C01_001.ai

Figure 4

Observe the following safety note if the NX Workstation is delivered as a laptop.

CAUTION:
The accumulated heat developed by the digitizer and the laptop may affect the
operation of the system.
Do not place the laptop on top of the digitizer.

NOTE:
Due to the workflow of the system it is recommended to install digitizer and
NX workstation close together.

DOCUMENT CONTROL NOTE:


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Edition 1, Revision 4 CR 30-X 2nd, Type 5175 / 200 / 205 / 220 / 225 Chapter 1 / Page 10 of 39
02-2012 CR 30-Xm, Type 5179 / 100 Agfa Company Confidential
DD+DIS230.10E Controls, Connections, and Setup Procedures

2.2 Switching on the Digitizer and NX Workstation

(1) Switch on the digitizer.


(2) Switch on the NX Workstation.
(3) Login with user "crservice".
ON

5175_C01_002.ai

Figure 5

IMPORTANT:
The digitizer always has to be switched on before the NX workstation, if both of
following conditions are fulfilled:
 NX software is NX 2.0.8500 / 3.0.8500 or NX 2.0.8600 / 3.0.8600
 Digitizer and NX workstation are connected directly via network cable
Workarounds to avoid a switch-on sequence:
Possibility 1: Use a network switch to connect digitizer and NX workstation.
Possibility 2: Connect digitizer and NX to the local network. See also section 3.

NOTE: blue
After switch on a selftest is executed. green or Status indicator
red
For explanation of the status indicator Erase button
colors see table next page.

5175_C01_003.ai

Figure 6

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02-2012 CR 30-Xm, Type 5179 / 100 Agfa Company Confidential
DD+DIS230.10E Controls, Connections, and Setup Procedures

Status Indicator Digitizer Status Meaning


Blue Constant Activating the erasure cycle. ON if erasure cycle active.
Constant Stand-by mode (READY) ON if:
 Ready / Stand-by

Green  Cassette is ready for removal.


Flashing Busy with scanning and ON during scan cycle active.
transporting cassette and
image plate.
Red Constant Service Mode or Service ON in case of Service Mode or
Required Service Required.
Flashing  Warm up / Self-test Check NX workstation for
further information and detailed
 Processing instructions.
 Software down Error resolvable by User.
 Error

2.3 Taking out the Digitizer USB Flash Drive

(1) Press both buttons at the feed A


table (A).
(2) Pull out the cassette unit (B).

B
5175_c35_00A.cdr

Figure 7

CAUTION:
Parts underneath the top cover can be damaged.
Carefully remove the top cover. Follow the instructions as shown in next step.

DOCUMENT CONTROL NOTE:


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Edition 1, Revision 4 CR 30-X 2nd, Type 5175 / 200 / 205 / 220 / 225 Chapter 1 / Page 12 of 39
02-2012 CR 30-Xm, Type 5179 / 100 Agfa Company Confidential
DD+DIS230.10E Controls, Connections, and Setup Procedures

(3) Remove two screws (A).


(4) Take off the top cover (B, C).

5175_c35_004.cdr

Figure 8
(5) Remove screw (A).
(6) Take out the USB flash B
drive (B).

5175_c35_backup1.cd

Figure 9
(7) Mount the Top Cover (A, B).
Do not mount the screws yet. A

5175_c35_404.cdr

Figure 10

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02-2012 CR 30-Xm, Type 5179 / 100 Agfa Company Confidential
DD+DIS230.10E Controls, Connections, and Setup Procedures

2.4 Installation of the Error Viewer on the NX Workstation

(1) Insert the USB flash drive at the NX workstation.


(2) Copy the file \ErrorViewer\ErrorViewerInstaller.msi from the USB
flash drive to the NX workstation (e.g. D:\drive)
(3) Execute the msi file on the NX workstation.
(4) Follow the installation instructions on the screen.

NOTE:
The error viewer is an interface for the operator of the digitizer. It does not only show
errors, but also digitizer status messages for the user.

2.5 Configuring the NX Workstation with Default Settings

(1) On the NX workstation go to:


Control panel

Set:
View by: Small Icons

Figure 11

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02-2012 CR 30-Xm, Type 5179 / 100 Agfa Company Confidential
DD+DIS230.10E Controls, Connections, and Setup Procedures

(2) Select: Control panel 


Date and Time.
(3) Adapt date and time.

Figure 12

(4) Select:
Control panel  Network
and Sharing Center 
Local Area Connection 
Properties  Internet
Protocol Version 4
(TCP/IPv4)  Properties

Set:
- IP address: 192.192.192.193
- Subnet mask: 255.255.255.0

For detailed instructions refer to


the NX Workstation Service
Manual chapter 4, Installation.

Figure 13

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02-2012 CR 30-Xm, Type 5179 / 100 Agfa Company Confidential
DD+DIS230.10E Controls, Connections, and Setup Procedures

(5) Select: Control panel 


System  Change Settings
 Change

Set computer name: DefaultNX

Figure 14

NOTE:
For details to the following steps refer to the latest NX Workstation service manual in
Agfa HealthCare Library: <Computed Radiography  CR Workstation
Software>
(6) Copy the application license file (ALF) to the NX workstation directory
C:\AGFA\Healthcare\NX\Configuration\Licensing).
(7) Enable the ALF-file with the License Manager.

(8) Start NX Activation Utility from the


desktop..
(9) During the "Activation process"
change the “Available Dose Types”
from <LGM> to <EI>.
(10) Select <None> as "Available Twain
Digitizer" and follow the
instructions on the screen.
(11) Start the NX Configuration Tool.
Figure 15

(12) Go to: General Settings  Configure Workstation Settings 


Workstation Settings

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02-2012 CR 30-Xm, Type 5179 / 100 Agfa Company Confidential
DD+DIS230.10E Controls, Connections, and Setup Procedures

(13) Following step is required for CR 30-X 2nd only (not for CR 30-Xm): Check
the software on the USB flash drive: The software, which is also installed on
the digitizer, is located in a directory \CIR_1103 (or higher version).
(14) Depending on the digitizer software version, adapt the workstation settings as
shown in following table:

# Parameter Value for CR 30-X 2nd Value for CR 30-X 2nd SW ≥


SW < CIR_1203 CIR_1203 and CR 30-Xm
1 ID station name DefaultNX DefaultNX
2 Performed Station AE Title NX_DefaultNX NX_DEFAULT
3 Processing station name local host local host
4 Port 104 104
5 Default Modality CR CR
6 Fast Preview Settings - AE FAST_DefaultNX FAST_DEFAULT
Title
7 Fast Preview Settings - 3729 3729
Port number
8 Enable Fast-ID Checkbox must be Checkbox must be activated
activated
9 Fast ID - AE Title FASTID_DEFAULTNX IDEN_DEFAULT
10 Fast ID - Port number 3216 3216

NOTE:
In the NX Configuration Tool the workstation IP address and Subnet mask are not
editable. Make sure that the correct IP address and Subnet mask are indicated as
configured in step (4) of this section.

(15) Go to Devices  Digitizer in the NX Configuration Tool.

(16) Enter the data for Recovery Exposure Types according to the customer
needs. Example:
- Age Group 17+
- Exam Group: Chest
- Exposure Type: Chest PA

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02-2012 CR 30-Xm, Type 5179 / 100 Agfa Company Confidential
DD+DIS230.10E Controls, Connections, and Setup Procedures

(17) In the same window select <New>


to add a new digitizer.
(18) Enter following data in the "Add
Digitizer" window.
- Name: DIG_DEFAULT
- Type: CR 30-X DICOM or
CR 30-Xm Figure 16
See also NOTE below:

NOTE:
 Digitizer type CR 30-X DICOM corresponds to CR 30-X 2nd.
 In software NX 2.0.8600 / 3.0.8600 the Mammography digitizer CR 30-Xm is not in
the list of digitizer types. To add the CR 30-Xm in the list proceed as follows:

Step 1: Download the CR 30-Xm model file from the Agfa HealthCare Library:
Computed Radiography > CR Digitizers > CR 30-X 2nd / CR 30-Xm
Step 2: Copy the model file to the NX workstation (e.g. D:\ drive)
Step 3: In the "Add digitizer" screen (see Figure 16) upload and select the model file.

(19) Depending on the digitizer software version, adapt the digitizer settings as
shown in following table:

# Parameter Value for CR 30-X 2nd Value for CR 30-X 2nd SW ≥


SW < CIR_1203 CIR_1203 and CR 30-Xm
1 Name: DEFAULTDXM DIG_DEFAULT
2 Enable Fast ID Checkbox must be activated Checkbox must be activated
3 Device settings: 192.192.192.192 192.192.192.192
IP Address
4 Device Settings: DEFAULTDXM DIG_DEFAULT
AE Title:
5 Device settings: 192.192.100.1 192.192.192.1
Default Router
6 Device settings: 255.255.255.0 255.255.255.0
Subnet Mask

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DD+DIS230.10E Controls, Connections, and Setup Procedures

(20) Enter the data in the Device Configuration  Digitizer 


Emergency Procedure window according to the customer needs.
The following table just shows an example:

# Parameter Value
1 Age Group: 17+
2 Exam Group: Chest
3 Exposure Type: Chest PA

(21) Select in the NX Configuration Tool Menu:


Devices  ID Tablet Configuration  ID Tablet
(22) Select: <Delete>
(23) Select in the NX Configuration Tool Menu:
User Interface  Editing Settings  Configure Normal Mode
& Print Mode
(24) Following step is only required for NX software version < NX 2.0.8700 /
3.0.8700: Change value for Content: LGM:(0018,1405) to
EI:(0018,1411)
(25) Activate the configuration. This will restart the NX Software.
After the reboot of the NX workstation the red blinking LED at the digitizer
changes to green. This indicates a connection to the NX workstation.

2.6 Testing Standalone Installation

(1) Insert an unexposed cassette in the digitizer.


(2) Identify the cassette: Scanning starts.
(3) Check, if the image arrives at the NX Workstation:
 If the image arrives at the NX Workstation, the system works and the
installation was successful.
 If the image did not arrive at the NX Workstation, troubleshoot as described
in CR 30-X 2nd / CR 30-Xm Service Manual, chapter 3.3, Troubleshooting.

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DD+DIS230.10E Controls, Connections, and Setup Procedures

2.7 Filling in Site specific Data

(1) Select: <Site Specific Data>


(2) Enter the site specific data.
(3) Select <OK> to save the data.
(4) Select <cancel> at request to
renew the external backup.

Figure 17

2.8 Checking Software Version

(1) Select: <Main Device Info>

Figure 18

(2) Check software version.


Make sure that the latest software version is installed. For more information how
to perform a software upgrade refer to the installation instructions which are
enclosed to the software on the Agfa HealthCare Library.

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DD+DIS230.10E Controls, Connections, and Setup Procedures

2.9 Configuring the Maintenance Indicator (Optional)

NOTE:
Only perform the following steps if you want to activate the maintenance indicator.

(1) Select: <Maintenance Indicator>


(2) Active the maintenance indicator (default = Off).

“On” (checkbox selected) means:


 Customer will be reminded daily or when starting the Control PC
to perform a preventive maintenance via following message:
o "Maintenance interval will expire within a short time. Please contact
service."
This message appears approximately 12 weeks before the defined
maintenance due date or due cycles (Default: 2 years / 30.000 cycles)
are reached.
o "Maintenance interval expired. Please contact service."
This messages appears, when the maintenance due date or
due cycles are expired is counter is reached.
“Off” means:
 Maintenance indicator is deactivated. The customer will not be reminded to
perform a preventive maintenance.

(3) If required adapt the target values for "Operating hours" and "Cycles" according
to the local terms of the service agreement.

Figure 19

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DD+DIS230.10E Controls, Connections, and Setup Procedures

3 Configuring the Digitizer and the NX Workstation for the


Hospital Network

REQUIRED TIME:
Approximately 10 minutes

3.1 Adapting the Local Settings and Network Settings at the Digitizer

(1) Select <Digitizer


Settings> and adapt
following parameters:
 Date
 Time
 User Interface Language
(language of the user
messages in the error
viewer)
 IP address (final IP address
in the hospital network)
 Subnet mask

Figure 20

3.2 Adapting the Communication Parameters at the Workstation

(1) On the NX Workstation go to the Windows control panel and configure IP


address, subnet mask and computer name with the information provided by the
hospital.
For detailed instructions refer to chapter 4 of the NX Workstation Service Manual.
(2) Start the NX Configuration Tool.
(3) Adapt the Workstation settings and the digitizer settings with the information
provided by the hospital and activate this configuration on the NX workstation.

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DD+DIS230.10E Controls, Connections, and Setup Procedures

3.3 Creating CPF File and Loading it to the Digitizer

(1) Insert the digitizer USB flash


drive (part of delivery) into
USB Port of the NX
Workstation.
(2) Click on <Create CPF> and
save the file on the USB flash
drive root folder.
(3) Release the USB flash drive
from the NX Workstation.

Figure 21

(4) Press both buttons at the feed A


table (A).
(5) Pull out the cassette unit (B).

B
5175_c35_00A.cdr

Figure 22

(6) Plug the USB flash drive into


the USB slot of the digitizer;
see Figure 17.
(7) Close the cassette unit.
(8) Wait until the Digitizer starts up.

5175_c35_094a.cdr

Figure 23

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DD+DIS230.10E Controls, Connections, and Setup Procedures

(9) On the NX workstation start the internet explorer.


(10) Enter the new digitizer IP address in the address window and press “enter”.
The digitizer service user interface opens.
(11) Select: <Digitizer Settings>
(12) Select <Remove Destinations> to delete the default destination
network settings.

NOTE:
After selecting the button <Remove Destinations> the button <Load Data from
USB stick> is active; see next step.

(13) Select: <Load Data from USB Stick>


(14) Select the digitizer from the list.
(15) Select <OK>.
(16) Reboot the digitizer.

Figure 24

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DD+DIS230.10E Controls, Connections, and Setup Procedures

4 Completion of Installation

This section describes the tasks that are required to prepare the digitizer for hand-over
to the clinical application specialist.

# Task Section
1 Checking the technical image quality of the digitizer. 4.1
3 Confirming the installation date of the digitizer software. 4.2
3 Performing a backup. 4.3
4 Storing the USB flash drive in its cover. 4.4
5 Handing-over the system to the Clinical Application 4.5
Specialist.

REQUIRED TIME:
Approximately 20 minutes

4.1 Checking the Technical Image Quality of the System

4.1.1 Selecting the required Cassettes

Selecting the cassettes and modality for exposure of the flatfield(s) depends on the
application type of the installed system:

Application Required Cassette Exposure at


Type Modality Type
Genrad only  Largest available Genrad cassette Genrad
Genrad and  Largest available Genrad cassette and Genrad
Mammography
 Mammography cassette 24x30 cm and
 Mammography cassette 18x24 cm (if
available)
Mammography  Mammography cassette 24x30 cm and Mammography
only
 Mammography cassette 18x24 cm
(if available)

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DD+DIS230.10E Controls, Connections, and Setup Procedures

4.1.2 Checking the Image Plate(s) before Exposure

(1) Open the cassette with the


dedicated key or a pen.

517509ag.cdr

Figure 25

(2) Open the shutter.


1
(3) Turn the cassette around, so that
the black tube side is above. 2

(4) Let the black tray and image plate


slide out carefully onto the table.
1

517509ad.cdr

Figure 26

(5) Put the black tray with the image


plate onto the cassette.
(6) Check the image plate for any
contaminations or signs of damage
(e.g. dust particles, scratches).

Figure 27

(7) If the image plate is contaminated clean it with CR Phosphor Plate Cleaner and a
soft lint-free cloth or Polynit wipes.

If the image plate is damaged take another cassette and inform the customer.

IMPORTANT:
When using CR Phosphor Plate Cleaner: Do not pour the CR Phosphor
Plate Cleaner directly on the image plate. Always pour the CR Phosphor
Plate Cleaner on the lint-free cloth.

(8) Wait approximately 10 minutes until the surface is dry.

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DD+DIS230.10E Controls, Connections, and Setup Procedures

(9) Verify that the white phosphor side


is oriented to the black tube side
of the cassette.
(10) Put the image plate back into the
cassette so that the shutter does 1 White phosphor side
not scratch over the image plate.
2

Black tube side of the cassette


517509af.cdr

Figure 28

(11) Insert the key or a pen into the cassette.


(12) Close the shutter
(13) Remove the key.

4.1.3 Erasing the Cassette

(1) Press the Erase button.

The Digitizer switches to erase


mode. The status indicator is
continuously lighting up in blue.

5175_c01_006.ai

Figure 29

(2) Put the cassette in the digitizer:


Erasing starts.

5175_c01_005.ai

Figure 30

(3) Remove the cassette with the erased image plate from the cassette output.

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DD+DIS230.10E Controls, Connections, and Setup Procedures

4.1.4 Creating the Flatfield Test Image at a Genrad Modality

NOTE:
Use a Genrad modality for exposure of the cassette(s), if the system is used for
Genrad or mixed use (Genrad and Mammography). For details refer to section 4.1.1.

(1) Mount the 1,5 mm Cu-filter at the


modality
(2) Place the Genrad cassette with the
black side facing up.
(3) Ensure that the entire image plate Cu filter
is fully exposed. The collimated
field must be larger than the image 1,3 m Black side
plate. facing up
Collimated
area

5175_c36_001.cdr

Figure 31

(4) Select the following exposure parameters to obtain a dose of 10 µGy:


 12 mAs
 75 kVp
 1.3 m (51,2”) distance
 Large focus
(5) Expose the cassette.
(6) Turn the cassette 180° (black side still facing up).
(7) Expose the cassette again.
After the second exposure the cassette has been exposed in total
with a dose of approximately 20 µGy.
(8) Repeat steps (2) to (7) with the Mammography cassettes (both formats, if
available).
(9) Remove the Cu-filter from the X-ray device.

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DD+DIS230.10E Controls, Connections, and Setup Procedures

4.1.5 Creating the Flatfield Test Image at a Mammography Modality

NOTE:
Only use a Mammography modality for exposure of the cassette(s), if the system is
used for Mammography exclusively.
If the system is used for Genrad, too, make all exposures for the flatfield image at the
Genrad modality.
For details refer to section 4.1.1.

(1) Using adhesive tape, mount the


Al-filter at the modality.
(2) Insert the Mammography cassette
with the black side facing up.

Figure 32

(3) Select the following exposure parameters:


 200 mAs
 28 kVp
 Mo / Mo
(4) Expose the cassette.
(5) Repeat the exposure for the other cassette format, if available.
(6) Remove the Al-filter from the X-ray device.

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DD+DIS230.10E Controls, Connections, and Setup Procedures

4.1.6 Scanning the Flatfield Image

(1) Insert the exposed cassette in the digitizer.


(2) At the NX workstation select the examination type:
For Genrad: <System Diagnosis  Flatfield> or
For Mammography: <System Diagnosis Mammo  Flatfield Mammo>
(3) Identify the cassette.
(4) Wait until the digitizer has finished the scan process.
(5) Print the image or send it to the archive (depending on what is available).

IMPORTANT:
By selection of examination type "System Diagnosis", the correct settings for image
processing of the flatfield are used. Any other examination type may give a result which
cannot be used to evaluate the flatfield image.

4.1.7 Checking the Images at the Lightbox or Viewing Station

NOTE:
Checking the images and comparing to the limit patterns may only happen on
lightboxes and viewing stations that comply with the specified installation and
configuration conditions for diagnostic reading. For details please refer to the
respective instructions of the viewing stations / light boxes.

NOTE:
The slow scan direction is always parallel to the short side of the image plate
(except 35 x 35 cm cassettes). Due to the hanging protocol* the appearance of the
saved flatfield might differ from the physical orientation of the cassette as it has
entered the digitizer.
 The hanging protocol (DICOM expression) defines the format and presentation
how the images are displayed on the monitor.

43 cm 30 cm 30 cm 24 cm
15 cm 18 cm
24 cm
Slow scan 35 cm
direction
517509ab.cdr

Figure 33

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DD+DIS230.10E Controls, Connections, and Setup Procedures

(1) Check the image quality of the flatfield for the following artifacts:
 Stripes in fast scan or slow scan direction
 Large area inhomogeneities
 Unacceptable number of white dots.

Evaluation:

(1) If the scanned flatfield does not show one of the artifacts, no further action
is required.
(2) If the scanned flatfield shows one of the artifacts compare the flatfield with the
limit pattern. For detailed instructions refer to chapter 3.2, Tools and auxiliary
Means.

IMPORTANT:
If a FLFS cassette for flatfield exposure is used, the image will be slightly darker
in the upper and lower image area where the backscatter protection is removed
(approximately 1 cm each). These darker zones also have to be used for image
quality evaluation in slow scan and fast scan direction.

Flatfield with Genrad Cassette Flatfield with FLFS Cassette

Effect exaggerated

Genrad Cassette FLFS Cassette

Backscatter
FLFS
Protection

10 mm

10 mm
FLFS

Figure 34

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DD+DIS230.10E Controls, Connections, and Setup Procedures

4.2 Confirming the Installation Date of the Digitizer

(1) Click <Logout>.


(2) Select <Installation> and click: <Yes>

Figure 35

(3) Confirm completion of installation by clicking: <Yes>

Figure 36

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DD+DIS230.10E Controls, Connections, and Setup Procedures

4.3 Performing a Backup

(1) Pull out the cassette unit.


(2) Plug the USB flash drive into
the USB slot of the digitizer.
(3) Close the cassette unit.

5175_c35_094a.cdr

Figure 37

(4) In service menu <Backup>


select <Complete backup>
and <SAVE TO USB>.
(5) Unplug the USB flash drive
when the message is
displayed: Remove USB
flash drive.

Figure 38

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DD+DIS230.10E Controls, Connections, and Setup Procedures

4.4 Storing the USB Flash Drive

(1) Open the cassette unit.


(2) Remove the top cover.
A
(3) Put the USB flash drive (A) in
its box and mount the
screw (B).
(4) Mount the top cover.
(5) Close the cassette unit.
B

5175_c35_backup5.cdr

Figure 39

4.5 Hand-over of the System to the Clinical Application Specialist

(1) Inform the Clinical Application Specialist about:


 Completion of technical installation
 Any irregularities during the installation
 The required activities as described in following table

# Activity Section
1 In case the system is used for Mammography: Perform 4.5.1
Mammography specific tasks.
2 Setup connectivity to additional system components 4.5.2
(RIS, PACS, Hardcopy, etc.).
3 Customize system components according to customer 4.5.3
preferences.
4 Train the customer. 4.5.4
5 Perform further activities depending on local regulations. 4.5.5

NOTE:
To get access to the Agfa HealthCare Library or to get a copy of the required
documents contact your local service manager.
External partners: Contact your local Agfa representative.

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DD+DIS230.10E Controls, Connections, and Setup Procedures

4.5.1 Performing Mammography specific Configurations and Tests

(1) In case the system is used for Mammography: Perform Mammography specific
configurations and tests.
For details see the Service Manual "CR Mammography Solution based on
CR30-Xm" on the Agfa HealthCare Library > Computed Radiography >
CR Mammography Systems > CR Mammo Solution (CR 30-Xm)

4.5.2 Setup of Connectivity to additional System Components

(2) Use the corresponding connectivity release documents for setup of additional
system components, see Agfa HealthCare Library path*:
<General Info  Connectivity & Application>
* External partners: Contact your local Agfa representative.

(3) Setup the connectivity to the additional system components as described in


the connectivity release documents.

4.5.3 Customizing System Components according to Customer Preferences

For instructions how to customize the system components refer to the corresponding
connectivity document and service manual of the system component.

4.5.4 Customer Training

(1) Hand-over the user manuals. The user manuals are also available on CD ROM
which is part of delivery.
(2) Train the customer in following activities:
 Operating the digitizer, see section 4.5.4.1.
 Usage of plates and cassettes, see section 4.5.4.2.

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DD+DIS230.10E Controls, Connections, and Setup Procedures

4.5.4.1 Training for Operating the Digitizer

Following items have to be part of the training for digitizer operation:


 The user interface (Status indicator / error viewer at NX workstation)
 Switching on/off/reset the digitizer
 Power and network connector
 Boot-up procedure
 Basic workflow
 Erasing image plates
 Retrieving Information about the digitizer
 Troubleshooting and errors during operation

NOTE:
For more information refer to the CR 30-X 2nd User Manual.
For NX workstation specific training refer to the NX workstation user documentation.

4.5.4.2 Training for Usage of Plates and Cassettes

Following items have to be part of the training for usage of plates and cassettes:
 Labels and functional elements of the cassettes
 How to detect Full Leg / Full Spine Cassettes (if available on site)
 First use and normal operation
 Storage and transport
 Operating conditions
 Cleaning

NOTE:
For more information refer to the user manual "CR 30-X/CR 30-Xm Plates and
Cassettes".

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DD+DIS230.10E Controls, Connections, and Setup Procedures

4.5.5 Performing further Activities depending on local Regulations

Enclosed a list of possible activities depending on local regulations:


This list is just an example.

# Activity Reference
1 Electrical check IEC 62353:2007 Test Documentation on
the Agfa HealthCare Library (Extranet Link /
Intranet Link)
2 Acceptance Test Example for Germany: DIN6868

(1) Contact your local service manager concerning the activities which are required
due to local regulations.

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DD+DIS230.10E Controls, Connections, and Setup Procedures

5 Installation Checklist

# Step Reference Okay Task


code*

Installation Prerequisites
1. Check installation site prerequisites. 1.1 PRI**
2. Prepare the required tools. 1.2 PRI
3. Unpack digitizer. 1.3 INS***
4. Check shipment completeness. 1.4 INS

Connecting the Digitizer to the NX Workstation


5. Connect cables. 2.1 INS
6. Switch on the digitizer. 2.2 INS
7. Take out the digitizer USB flash drive 2.3 INS
8. Install the error viewer 2.4 INS
Configure the NX workstation with default
9. 2.5 INS
settings.
10. Test the standalone installation. 2.6 INS
11. Fill in site specific data. 2.7 INS
12. Check software version. 2.8 INS
13. Configure the Maintenance Indicator (Optional). 2.9 INS

Configuring the Digitizer and the NX Workstation for the Hospital Network
Adapt local settings and network settings at the
14. 3.1 INS
digitizer
Adapt communication parameters at the NX
15. 3.2 INS
workstation.
16. Create CPF file and load it to the digitizer. 3.3 INS

* Task Code, only applicable for Agfa employees


** PRI = Pre-Installation
*** Ins = Installation task

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DD+DIS230.10E Controls, Connections, and Setup Procedures

# Step Reference Okay Task


code*

Completion of Installation

17. Check technical image quality of the digitizer. 4.1 INS

18. Confirm the installation date of the digitizer. 4.2 INS

19. Perform a backup. 4.3 INS

20. Store USB flash drive in its cover 4.4 INS


Hand-over the system to the Clinical Application
21. 4.5 INS
Specialist.

Further activities:
In case the system is used for Mammography:
22. Perform Mammography specific configurations 4.5.1 ASC
and tests.
Setup connectivity to additional system
23. 4.5.2 ASC
components (RIS, PACS, Hardcopy, etc).
Customize system components according to
24. 4.5.3 ASC
customer preferences.
25. Train the customer. 4.5.4 ATR***
Perform for further activities depending on
26. 4.5.5 ABA****
local regulations.

* Task Code, only applicable for Agfa employees


** ASC = Configuration & Customization
*** ATR = Customer training
***** ABA = Acceptance Testing

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