Philips PCR Eleva User manual
Digital Radiography
INSTRUCTIONS FOR USE
4512 987 02701/Rev. AA/732/2005-09
PCR Eleva
PHILIPS COMPUTED RADIOGRAPHY
Release 1.0
English
PCR Eleva
INSTRUCTIONS FOR USE
English
Philips Medical Systems 2005-10-04
Instructions for Use
All rights reserved. Philips Medical Systems
DMC GmbH reserves the right to make
changes in specifications or to discontinue any
product, at any time without notice or
obligation, and will not be liable for any
consequences resulting from the use of this
publication.
Printed in Germany.
Document number:
4512 987 02701/Rev. AA/732/2005-09
Internet address: www.medical.philips.com
Copyright
© 2005 Philips Medical Systems DMC GmbH
Röntgenstrasse 24
D-22335 Hamburg
These Instructions for Use are translated from
the German.
When receiving data media the user acquires a
non-exclusive, non-transferable right to use the
software stored on them in connection with the
hardware components delivered with it by
Philips.
Changes to software, the use of which on
hardware components other than those
delivered by Philips in this connection
(multiple use) or the making of copies, even for
purposes of data backups, must be approved by
Philips in writing beforehand. This manual
describes the equipment as delivered. Philips
accepts no guarantee for any modifications
which the user performs to the configuration.
PCR Eleva
Philips Medical Systems
Release 1.0
Contents
1 Introduction ............................................................ 1-1
1.1 The PCR Eleva
1.2 About these Instructions for Use
1.3 Normal use
1.4 Prohibited use
1.5 Conformity
1.6 Training
................................................................................1-3
.....................................................................1-1
........................................1-2
...........................................................................1-3
......................................................................1-3
...........................................................................1-3
2 Safety ....................................................................... 2-1
2.1 Safety
2.2 Electrical safety
2.3 Mechanical safety
2.4 Fire safety
2.5 Laser radiation warning
2.6 Special safety information
2.7 Electromagnetic compatibility (EMC)
2.8 Error messages
.....................................................................................2-1
....................................................................2-2
.................................................................2-2
.............................................................................2-2
.......................................................2-2
...................................................2-3
...............................2-4
......................................................................2-6
Philips Medical Systems
3 System description................................................. 3-1
3.1 Standard workflow
3.2 The operator's console
3.3 PCR plate reader
..............................................................3-4
.........................................................3-5
..................................................................3-6
4 Switching the system on/off .................................. 4-1
4.1 Switching on
4.2 Switching off
.........................................................................4-1
........................................................................4-2
5 PCR plate reader.................................................... 5-1
5.1 The PCR Compano plate reader
5.2 The PCR Corado and CosimaX plate readers
5.3 Making exposures
............................................................... 5-19
5.4 Handling cassettes and image plates
5.5 Notes on radiography
........................................................ 5-22
........................................5-1
................. 5-10
................................ 5-21
PCR Eleva
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Contents
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Contents
6 The operator's console .......................................... 6-1
6.1 What the operator's console can do
6.2 How to use the operator's console
................................... 6-1
..................................... 6-4
7 Patient administration........................................... 7-2
7.1 Entering patient and examination data
7.2 Getting patient data from RIS
......................................... 7-12
............................. 7-4
8 Performing the examination................................. 8-1
8.1 Overview
8.2 Examination procedure – Overview
8.3 Examination steps in detail
8.4 Workflow control
.............................................................................. 8-1
................................... 8-3
................................................ 8-5
.............................................................. 8-10
9 Review/image processing....................................... 9-1
9.1 Image processing tool functions
9.2 Individual image processing tools
......................................... 9-2
...................................... 9-3
10 Print ....................................................................... 10-1
10.1 Overview
............................................................................ 10-1
11 System administration and customization........ 11-1
11.1 Adjusting the touch screen ........................................11-6
12 Service, cleaning, disposal ................................... 12-1
12.1 Service
12.2 Tests by the user
12.3 Cleaning
12.4 Disposal
................................................................................. 12-1
................................................................ 12-2
............................................................................. 12-3
.............................................................................. 12-6
13 Technical data ...................................................... 13-1
13.1 General data
13.2 Electromagnetic compatibility (EMC) data
13.3 Labels
.................................................................................. 13-7
....................................................................... 13-1
.................... 13-6
Philips Medical Systems 2005-10-04
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Contents PCR Eleva
Release 1.0
Contents
14 Appendix ............................................................... 14-1
14.1 Notes on radiography techniques with UM and DRR
14.2 If the barcode reader is not working
.............................. 14-11
... 14-1
15 Glossary................................................................. 15-1
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PCR Eleva
Release 1.0
Contents
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Contents
I-4
Contents PCR Eleva
Philips Medical Systems 2005-10-04
Release 1.0
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1
1.1
Introduction
The PCR Eleva
This system is designed for digitizing cassette exposures on conventional
examination workstations in diagnostic radiology. The PCR system uses socalled image plates instead of screen-film systems.
With PCR systems you can make, digitize, process and transfer filmless
cassette exposures. They are fully automatic – from the entering of the
patient data and processing parameters through to film composition.
You can print any required films of these exposures.
The PCR system automatically communicates with other DICOM partners
and archives via the hospital network. Two-way data transfer with an existing
RIS (
communication within the radiology department.
adiology I nformation S ystem) guarantees efficient data
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Introduction
1-1
1.2 About these Instructions for Use
-
1.2
DANGER!
Warning!
About these Instructions for Use
This manual is intended to make it possible for you to work with the device
described safely.
You may not be able to use some of the functions described in this manual
unless you have the corresponding license.
Please pay particular attention to all the information given in chapter 2
“Safety”.
Conventions
This symbol identifies instructions which you must always observe in order to
avoid injuring patients and/or staff.
This symbol identifies instructions which you must observe to avoid damaging
the device described.
This is used to identify special advice, e.g. to assist the operator or to improve
an operating sequence.
Single steps of instruction sequences are preceded by consecutive numbers
1
(as shown here).
The result produced by a step is preceded by a dash (as shown here).
System configuration
This manual describes the system with its broadest range of features,
including all possible functions, options and all accessories. It is not essential
for your system to have every function described.
You can only use some of the functions if you have received training in them
by an application specialist, and have specially logged on to get these
privileges. Such functions are marked “For the system manager only”.
Depending on the features you have, other manuals may be delivered with
your system; these contain instructions on safety, calibration, system tests
and service and maintenance.
These Instructions for Use are translated from the German and were created,
authorized and marketed by Philips Medical Systems DMC GmbH under
the number given on the front cover.
1-2
Introduction PCR Eleva
Philips Medical Systems 2005-10-04
Release 1.0
Normal use 1.3
1.3
1.4
1.5
Normal use
The PCR Eleva system is designed to process, display and output
radiological images produced by means of cassette exposures and processed
within the PCR system.
The PCR Eleva system is not suitable for processing and displaying images
produced on other manufacturers' systems or compressed using non-system
software.
This device may only be operated by suitably qualified persons who have
been instructed on how to operate the device.
Prohibited use
The system is not approved for diagnosis.
Conformity
0123
1.6
DANGER!
This Medical Device meets the provisions of the Medical Device Directive
93/42 EEC (93).
Information about conformity with international/national standards can be
provided by
Philips Medical Systems DMC GmbH
Quality Assurance Department
Röntgenstrasse 24
D-22335 Hamburg
Fax: (+49) 40 / 5078 - 2147
Training
To work with the PCR system you must have fundamental specialist
knowledge of radiology, image-based medical diagnostics and digital image
processing.
The incorrect use of image processing functions can give rise to false
information in the image. Image information of relevance to diagnosis may be
suppressed or misrepresented. You should have expert knowledge of digital
image processing to change processing protocol settings.
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Training requirements for this X-ray equipment can vary from country to
country. The user must ensure that the operators are trained in accordance
with local and national regulations of a statutory nature.
Introduction
1-3
1.6 Training
Philips recommends that all operators take part in special training on how to
handle this product safely.
Further information on training is available from your Philips Service
Organization.
1-4
Introduction PCR Eleva
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2
2.1
DANGER!
Safety
Safety
You may only use this device in compliance with the safety instructions in
this manual and not for purposes other than those for which it was intended.
It is always the user who is responsible for conforming to the regulations
which apply to the setting up and operation of medical equipment.
You must not use the equipment if it has any electrical or mechanical defects.
This particularly applies to faults in indicators, displays, warnings and alarms.
• If the user wishes to connect the equipment to other equipment,
components or assemblies and if it is not apparent from the technical data
whether it can be safely combined with such equipment, components or
assemblies, the user must consult the manufacturers concerned or an
expert to ensure that the safety of the patient, operating staff and the
environment is not affected by the intended combination.
• Philips only accepts responsibility for the safety features of its products if
maintenance, repairs and modifications are performed by Philips or
persons explicitly authorized to do so by Philips.
• As with any technical appliance this equipment also calls for proper
operation and regular competent maintenance and care, which are
described in the section “Service and cleaning”.
• If you operate the equipment incorrectly or if the user fails to maintain it
properly, Philips cannot be held liable for any resulting faults, damage or
injuries.
• Safety circuits may be neither removed nor modified.
• You may only remove or open parts of the housing if you have been
instructed to do so by this manual.
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Safety
2-1
2.2 Electrical safety
Warning! You may not transport this equipment while it is in operation. Shut down the
2.2 Electrical safety
This device conforms to safety class I and type A according to IEC 60601-1.
This equipment may only be operated in medical rooms which meet IEC
requirements.
To guarantee the reliable operation of the workstation and to prevent the
device from overheating, the device openings must not be blocked off or
covered. The workstation must never be positioned near radiators.
Some of the workstation components are high-voltage. Only electricians may
remove the device's covers.
2.3 Mechanical safety
equipment before transportation and ensure that all peripheral parts of the
system (monitor, mouse, keyboard, cables etc.) are disconnected and safely
transported.
2.4 Fire safety
DANGER! • Only use fire extinguishers intended for use on electrical and chemical fires,
and marked as such. Any attempt to extinguish electrical fires with water or
other liquids can result in serious personal injury.
• The air vents may not be covered when the device is switched on.
2.5 Laser radiation warning
All plate readers use laser radiation (class IIIb, 50 mW).
DANGER! • Under no circumstances should you open the housing of the plate reader.
Contact, especially eye contact, with laser radiation can cause damage to
health.
• In the event of a malfunction, please notify suitably qualified staff only.
2-2 Safety PCR Eleva Release 1.0
Philips Medical Systems 2005-10-04
Special safety information 2.6
2.6 Special safety information
2.6.1 Loss of data due to power outage
This device should be connected to an uninterruptible power system to
prevent database damage and image loss in the event of a power outage.
2.6.2 Inferior quality due to multiple exposure
Images processed using the UNIQUE technique must only have been
exposed on the cassette as a single exposure. If a cassette is exposed more than
once the quality when processing using the UNIQUE technique can
deteriorate due to misinterpretation of the image information.
2.6.3 Damage as a result of incorrect cassette insertion
Always slide the cassettes into the cassette compartment of the plate reader
with care. Incorrect insertion of a cassette, for instance if it is at an angle, can
damage the plate reader. Please observe the instructions in chapter 5.1.2.
2.6.4 Data inconsistency
Do not switch off the operator's console at the power switch if the PCR
application program is displayed. This can lead to database errors or data
inconsistencies. Always follow the sequence for switching off as described in
chapter 4.
2.6.5 Cleaning and care
Warning! • Ensure that no liquid can enter the devices, otherwise a short circuit or
corrosion of components may occur.
• Only use a moist cloth with a mild detergent to clean computer housing,
keyboard, mouse and monitors.
For further information on this see chapter 12.3.
Philips Medical Systems 2005-10-04
PCR Eleva Release 1.0 Safety 2-3
2.7 Electromagnetic compatibility (EMC)
2.7 Electromagnetic compatibility (EMC)
The system conforms to the classification Group 1, Class B under
CISPR 11. It contains Class A IT components according to CISPR 22.
Although it has been shown that this does not have a detrimental effect on
the performance and safety of the system, electromagnetic incompatibilities
may arise when operated in residential areas. In such an event, it may be
necessary for the user to take appropriate measures.
In accordance with its intended use, this apparatus complies with the
European Council Directive concerning medical devices, which documents
CE-marking. That includes specifications on the maximum permissible level
of electromagnetic emission and requirements as to immunity to interference
by other devices.
It is not possible, however, to exclude with absolute certainty that radio
signals from high frequency equipment, which is fully compliant with the
EMC regulations, will not affect the proper function of this system. If a
device has a comparatively high level of transmission power and is operated
in close proximity, the EMC concerns (the risk of interference) may be
particularly pronounced. It is therefore recommended that the operation of
equipment of this type, such as mobile telephones (cell phones), cordless
microphones, and other similar mobile radio equipment, be avoided in the
vicinity of this system.
For further information on this, see chapter 13.2.
Explanation
Electronic apparatus that satisfies the EMC requirements is designed so that
under normal conditions there is no risk of malfunction caused by
electromagnetic interference. However, in the case of radio signals from
high-frequency transmitters with a relatively high transmission power, the
risk of electromagnetic incompatibility when operated in close proximity to
electronic apparatus cannot be totally ruled out.
In unusual circumstances unintended functions of the apparatus could be
initiated, possibly giving rise to undesirable risks for the patient or operating
staff.
For this reason, all kinds of transmission with mobile radio equipment
should be avoided. This also applies when the apparatus is in “standby”
mode.
Mobile telephones must be switched off in designated problem zones.
2-4 Safety PCR Eleva Release 1.0
Philips Medical Systems 2005-10-04
Electromagnetic compatibility (EMC) 2.7
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PCR Eleva Release 1.0 Safety 2-5
2.8 Error messages
2.8 Error messages
When an error has occurred in the system or a part of the system, an error
message appears on the operator’s console monitor with instructions on how
to rectify it.
Example:
1
Legend Function Meaning What you must do
1 Error message (e.g.)
2 System status
display
Current system error
status:
Green circle:
Everything OK
Yellow triangle:
Error
e.g. reader not ready for
use.
Red cross:
Unrecoverable error
Click on symbol: more
information appears.
Click on symbol: more
information appears.
2
DANGER! Even if no error message appears, but the equipment does not function as
usual (first signs of a defect) Philips Service Organization must be informed.
2-6 Safety PCR Eleva Release 1.0
Philips Medical Systems 2005-10-04
3 System description
The basic system consists of
• an operator's console with monitor or touch screen, barcode reader,
keyboard and mouse
• a plate reader.
When you work with a touch screen you require neither a mouse nor
keyboard for operation.
You can combine more than one plate reader and operator's console to form
a system.
During exposure there is no mechanical connection between plates and
system, so that in the event of incorrect configuration or cassette use, the
system cannot, for instance, accurately show the status of a flipped image or
the assignment to a patient.
Philips Medical Systems 2005-10-04
PCR Eleva Release 1.0 System description 3-1
3.0.1 Possible configurations
One-console system with one plate reader
This configuration is the basic configuration for a PCR system. You can
work with or without being connected up to the hospital network.
Plate reader
PCR operator’s console
Hospital network
Multiple-console system with one plate reader
Printer
This configuration is the extended basic configuration. To achieve a more
efficient workflow, you can set up more than one operator's console, e.g. in
the various examination rooms and in patient admissions. At the same time,
the entire system is connected up to the hospital network. The assignment of
image plate to patient and vice versa is always unique.
PCR operator’s console
in examination room
Plate reader
PCR operator’s console
at plate reader
Hospital network
Printer
3-2 System description PCR Eleva Release 1.0
Philips Medical Systems 2005-10-04
Multiple-console system with more than one plate reader (option)
With configurations of this type you can read out any plate cassette on any
plate reader, regardless of the operator's console on which you assigned the
image plate, or with which console the patient data is managed. After
readout the image always comes to the operator's console to which the image
plate is assigned.
Plate reader
Plate reader
Hospital network
PCR operator’s consoles
The following applies to all configurations:
• All operator's consoles have independent worklists and are synchronized
PCR operator’s consoles
Printer
with the RIS separately.
• On any one operator's console you can view, process, print and export
only the images assigned to it. You should therefore perform an
examination to the fullest possible extent on one operator's console only.
Server and client:
• In a multiple-console system, one console is always the server, which
assigns the image plates and distributes the images. If this breaks down or
is not switched on, no image plates can be assigned or images read out in
the entire system. Always switch the server on first and off last.
• If, in a multiple-console system with more than one plate reader, the server
is down, the system manager can convert the operator's consoles which
operate another plate reader into servers so that it is possible to continue
working with part of the system.
Philips Medical Systems 2005-10-04
PCR Eleva Release 1.0 System description 3-3
3.1 Standard workflow
r
3.1 Standard workflow
On the operator’s console
The following diagram shows the standard workflow with the PCR system.
You will find alternatives to the described assignment with the barcode
reader in the rest of the manual.
The differences to conventional radiography are as follows:
• You work with plate cassettes instead of film cassettes.
• Before radiography, you must assign the plate cassette to a view using the
barcode reader.
• After radiography, you must read out the plate cassette in the plate reader.
• The X-ray exposure is automatically transferred from the plate reader to
the operator's console.
• For filing purposes, you can print out the X-ray exposure or save it on
computer.
Standard workflow on the PCR system (example)
On the diagnostic unit
On the plate reader
On the operator’s console
RIS query or patient entry
Select patient
Select Examination section
Select view(s)
Assign image plate(s)
with barcode reader
Make exposure(s)
Slide in cassette(s)
Take out cassette(s)
Check image quality
Examination section opens
Image plate is assigned to the
selected view
Image plate is read out
and erased
Exposures appear on the
operator’s console
Edit exposure if necessary
Print film
Archive exposures
Complete examination
3-4 System description PCR Eleva Release 1.0
and/or
save to image archive on compute
Philips Medical Systems 2005-10-04
The operator's console 3.2
3.2 The operator's console
Overview of the sections
12 3 4 5
You can select the sections using the main selector buttons (
1-5). When a
section is selected the button for it turns yellow.
You can do the following in the sections:
Number Function Meaning
1 Patient list Enter patient and examination data and select
patients.
2 Examination Control the examination, assign and insert image
plate.
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PCR Eleva Release 1.0 System description 3-5
3 Review Check and, if necessary, improve the image quality.
4 Print You will find the printing tools here.
5 System Exit the application program,
functions for the system manager.
3.3 PCR plate reader
3.3 PCR plate reader
3.3.1 The PCR Compano plate reader
1 2 3 4 5 6 7
8
9
1011
The plate reader reads out the exposed image plates. The image plates are
contained in the plate cassettes.
3-6 System description PCR Eleva Release 1.0
Philips Medical Systems 2005-10-04
PCR plate reader 3.3
No. Meaning
1 Control panel with operating indicators
2 Load lamp
Lights up green once the start-up procedure after switching on has been
successfully completed and the plate reader is ready to process cassettes.
3 Status displays for cassette processing
They flash during cassette processing.
4 Unload lamp
Lights up green once cassette processing is finished. The cassette can be taken
out.
5 Message indicator
When it lights up (yellow), a window with special instructions appears on the
monitor of the operator's console. Follow these instructions. If an error
message appears, an audible warning signal is given.
6 “Erase” button for primary and secondary erasure
Pressing the button once activates the secondary erasure mode, and
appears next to the button. Press it again to activate the primary erasure
mode, and appears. To return to the routine mode, press the button again.
7 Pilot lamp
Lights up green when the main switch is in position “I” (on).
8 Cassette compartment
For exposing a cassette with the image plate.
9 Reset switch
Only for restarting in the event of disruptions; do not press it under normal
operating conditions.
10 Main switch
Is always left in position “I” (on). Switching it off is only advisable in the event of
prolonged stoppages.
11 Dust filter/ventilator
A dust filter is fitted over the ventilator.
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PCR Eleva Release 1.0 System description 3-7
3.3 PCR plate reader
3.3.2 The PCR Corado and CosimaX plate readers
1
10
8
3
4
7
9
2
5
6
The plate reader reads out the exposed image plates. The image plates are
contained in the plate cassettes.
3-8 System description PCR Eleva Release 1.0
Philips Medical Systems 2005-10-04
PCR plate reader 3.3
No. Meaning
1 Control panel
Plate reader's touch-sensitive control panel (touch screen).
2 Pilot lamp
Lights up green when the main switch is in position “I” (on).
3 Power switch
Switches on the plate reader if the main switch is in position “I” (on).
4 Cassette compartment number
5 Unload lamp
Flashes blue once cassette processing is finished. The cassette can be taken out.
6 Processing lamp
Flashes while the cassette is being processed by the plate reader. During this
time the cassette is locked in the cassette compartment.
7 Load lamp
Lights up green once the start-up procedure after switching on has been
successfully completed and the plate reader is ready to process cassettes.
8 Four cassette compartments
For the simultaneous processing of up to four cassettes.
9 Dust filter/ventilator
A dust filter is fitted over the ventilator.
10 Main switch
Is always left in position “I” (on). Switching it off is only advisable in the event of
prolonged stoppages.
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PCR Eleva Release 1.0 System description 3-9
3.3 PCR plate reader
3-10 System description PCR Eleva Release 1.0
Philips Medical Systems 2005-10-04
4 Switching the system on/off
4.1 Switching on
Philips recommends the following sequence:
1 Switch on PC.
2 Log on to program.
- Enter user name
- Enter password
3 Switch on the plate reader.
Philips Medical Systems 2005-10-04
PCR Eleva Release 1.0 Switching the system on/off 4-1
4.2 Switching off
4.2 Switching off
The system is designed for continuous operation. It is therefore only necessary
to switch off all components in the event of prolonged stoppages.
4.2.1 One-console system
1 Switch off plate reader.
System
2 Press System
- The System section appears
Exit
4.2.2 Multiple-console system
3 Press Exit
4 Switch off PC
Proceed as under 4.2.1, but switch the server on first and off last.
4-2 Switching the system on/off PCR Eleva Release 1.0
Philips Medical Systems 2005-10-04
5 PCR plate reader
5.1 The PCR Compano plate reader
5.1.1 Switching on/off
The plate reader is designed for continuous operation. It is therefore only
necessary to switch it off in the event of prolonged stoppages.
Switching on
Pre-condition:
The PC and the application program on the operator's console have been
started up.
1 Press main switch to the “I” position.
Philips Medical Systems 2005-10-04
- The pilot lamp on the control panel of the plate reader lights up.
- The plate reader begins the start-up procedure, which takes a short
time. Then the load lamp lights up.
PCR Eleva Release 1.0 PCR plate reader 5-1
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