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user manual

code 79 80 002

series 03

Distributed by: GMM


Via Partigiani, 25
24068 SERIATE (BG) ITALY
tel. ++39 035 4525311

Responsibility for compliance with EEC 93/42: ATS


Via A. Volta, 6
24060 TORRE DE’ ROVERI (BG) ITALY
tel. ++39 035 584311
OPERA D4000
series 03

USER MANUAL
issued on 15/07/03
approved by the Design Office
USER MANUAL for series 03

Part 0: GENERAL INDEX

LIST OF CONTENTS

PART 0: GENERAL INDEX


PART 1: GENERAL DESCRIPTION
PART 2: USE
PART 3: TECHNICAL DATA

Each part is preceded by its own list of contents and details of the last updating of each
paragraph.

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USER MANUAL for series 03

Part 1: GENERAL DESCRIPTION

LIST OF CONTENTS

page ed. date

CONTENTS I.1 0 15/07/03

1 DESCRIPTION OF THE EQUIPMENT


1.1 Applications 1.1-1 0 15/07/03
1.2 Composition 1.2-1 0 15/07/03
1.3 Working monitor 1.3-1 to 1.3-12 0 15/07/03
1.3.1 Control strip
1.3.2 Main menu
1.3.3 Acquisition setup
1.3.4 Acquisition
1.3.5 Search
1.3.6 Processing
1.3.7 Angio
1.3.8 Memory
1.3.9 Misc
1.4 Infrared remote control 1.4-1 0 15/07/03
1.5 Display station 1.5-1 0 15/07/03

2 SAFETY
2.1 Introduction 2.1-1 0 15/07/03
2.2 Liability statement 2.2-1 0 15/07/03
2.3 Conformity and reference standards 2.3-1 0 15/07/03
2.4 Safety procedures 2.4-1 0 15/07/03
2.4.1 Electrical safety
2.4.2 Ionising radiation protection
2.5 Residual risks 2.5-1 0 15/07/03
2.6 Indications 2.6-1 to 2.6-4 0 15/07/03
2.6.1 Symbols
2.6.2 Operator and alarm messages

3 APPENDICES
3.1 ATS control console 3.1-1 to 3.1-4 0 15/07/03
3.1.1 Pushbutton panel
3.1.2 Display

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USER MANUAL for series 03

1 DESCRIPTION OF THE EQUIPMENT

1.1 APPLICATIONS

The OPERA D4000 (hereafter simply “the system”) is a digital image acquisition and processing
system designed for modern digitised radiology rooms.

It lets you acquire X-ray images in the following modes:

- Continuous fluoroscopy
- Low dose continuous fluoroscopy
- HCF pulsed fluoroscopy
- Low dose HCF pulsed fluoroscopy
- High resolution fluorography
- Low resolution fluorography
- Subtractive fluorography (optional)
- Tomography
- Cinematography (optional).

The acquisition, processing and display parameters can be personalised for 5 different types of exam:

- Skeleton
- Paediatrics
- Contrast
- Angiography (optional)
- Cardiovascular (optional).

There are 20 function modes for each exam type to suit the part of the body being scanned.

The system allows for digital processing of the acquired images (post-processing).

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1.2 COMPOSITION

The system consists of:

1. High contrast image intensifying tube – 9”, 12” or 16”


2. One-way optical distributor with photo-diode sensor for dose control
3. High-resolution CCD TV camera
4. PID image processor
5. Main Controller
6. Power unit.
7. Mouse and alphanumerical keyboard *.
8. Display and command console * (optional).
9. 21” working monitor
10. 21” reference monitor (optional)
11. 17” monitor for direct imaging (optional)
12. 17” reference monitor (optional)
13. Monitor stand (optional), for 17” monitors
14. Infrared remote control (optional).
15. Infrared remote control receiver (optional).

15

14 230 VAC Mains


11
to X-ray generator
12 4
to exam table
5
6

2
13
3

10
7

* Note: The figure shows the alphanumerical keyboard with the ATS Console (optional).

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1.3 WORKING MONITOR

During acquisition and post-processing, the active frame on the working monitor (21” workstation) is
split into two:

- Image area
- Control strip.

The image area displays the current images together with certain patient and exam data. The data are
split into five groups, as described further on.

Service messages are also displayed above the image.

1 2

4 3
Service messages

The service messages are listed in paragraph 2.6.2 in this part of the manual.

The other data belonging to the four groups are listed in the table below:

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group data example notes / meaning

1 Patient: name MARIO BIANCHI


date of birth 01 Jan 1930
sex M
identification no. 08/11/99a023
Operator Dott.ROSSI
2 Hospital identification ATS
Date and hour of acquisition 20 Apr 2000 08:43
Time since start of run Lap: 0.500s The image has been acquired 0.5 s after the
start of the current run
3 Angiography data MASK 3/2 Mask: 3rd image of the 2nd run
DELAY sec Time lapse between the mask and the current
subtracted image
Run identification Run 1/3 1st of the 3 runs in the exam
Image identification Image 2/5 2nd of the 5 images in the run
4 I.I. field II: 40 40 cm I.I. field
Dynamic range DR: 3 Dynamic range 1:3
(The dynamic range can be from 1:2 to 1:8)
Acquisition matrix MTX:HH12 High horizontal resolution (1024 pixels)
High vertical resolution (1024 pixels)
Depth 12 bits
MTX:HL12 High horizontal resolution (1024 pixels)
Low vertical resolution (512 pixels)
Depth 12 bits
MTX:LL12 Low horizontal resolution (512 pixels)
Low vertical resolution (512 pixels)
Depth 12 bits
MTX:HH8 High horizontal resolution (1024 pixels)
High vertical resolution (1024 pixels)
Depth 8 bits
Acquisition technique AT: S12 12th skeleton exam
AT: P8 8th paediatrics exam
AT: C3 3rd contrast exam
AT: A11 11th angiography exam
AT: H15 15th cardiovascular exam
Exposure technique TC: FL Fluoroscopy
TC: RX Fluorography
TC: PL Pulsed fluoroscopy
TC: CN Cinematography
Image brightness level L: 0 Brightness 0 (variation range 0 – 4096)
Image contrast window W: 4096 Window 4096 (variation range 50 – 4096)
Spatial Filter E: 7-1 SH Kernel 7x7, Weight 1, Sharp Filter
5 Image position Straight image
(marker) (reverse & rotation) Horizontal reverse
Vertical reverse
90° rotation
Labelling Image labelled by operator
Image labelled by system (automatically)
Mask Masked image
Subtraction Subtracted image
Road Mapping Road Mapping function

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1.3.1 CONTROL STRIP

The control strip is organised into 9 zones, as shown in the figure below.

1. Main menu: Patient list


Control strip hide
Exam type
Exam folder

2. Acquisition setup: Fluorography mode


Fluoroscopy mode
Acquisition speed
(for fluorography and pulsed fluoroscopy)
Dose control (automatic/manual)
Fluorography acquisition matrix
Fluoroscopy dose
I.I. field
Available memory on Hard Disk

3. Acquisition: Recursive filter


Horizontal reverse
Vertical reverse

4. Search: Search run forwards / backwards


Search image forwards /
backwards
Cine-loop

5. Processing: Electronic shutter


Brightness, contrast and gamma
Spatial filter
Harmonisation filter
Overview
Zoom
Overlay and measurements
Image labeller
Film Editor
90° image rotation

6. Angio: Mask
Shifting mask
Image subtraction
Pixel shift
Vascular tracing
Land marking

7. Memory: Saving in fluoroscopy mode


Transfer to Reference Monitor
Select image on Reference Monitor

8. Misc: Transfer image to network


Delete image or run
Utility tools

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1.3.2 MAIN MENU

The top section of the menu bar, called the “MAIN MENU”, contains 2 command icons and 2 selection
icons:

1 2

5 4

1 Patient list.
To go to the patient list.

2 Hide control strip.


This command hides the command strip: click on the icon again to view the command strip
again.
Note: If the ToolBar is set to "auto hide" in the “General Setting“ configuration, the command strip
will be automatically hidden during fluoroscopy and only displayed again when you release
the fluoroscopy footswitch.

3 Exam type.

Exam Skeleton
Paediatrics
Contrast
Angiography
Cardiovascular

4 Exam folder.

Lock-in not used

5 Lock-in active indication.


This automatically appears when you select
an exam folder set with an active lock-in. Lock-in active

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1.3.3 ACQUISITION SETUP

This window displays the system acquisition


1
settings:
4
2

5 3

7
6

8
9
10

1. Fluorography mode.

Cinematography

Tomography

Standard graphy

2. Fluorography acquisition speed.


Possible speeds: single, 0.5 i/s, 1i/s, 2i/s, 3i/s, 6i/s, 10i/s, 15i/s, 30i/s.
Note: The speed 30i/s is only possible in low resolution mode (512x512 matrix).

3. Fluorography dose control mode.


automatic control
manual control

4. Fluorography resolution high resolution


(acquisition matrix). (1024x1024 pixels)

low resolution
(512x512 pixels)

5. Fluoroscopy mode.

Continuous fluoroscopy

Pulsed fluoroscopy

Road mapping

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6. Pulsed fluoroscopy acquisition speed.


Possible speeds: 0.5 i/s, 1i/s, 2i/s, 3i/s, 6i/s, 10i/s, 15i/s, 30i/s.

7. Fluoroscopy dose level:

Normal dose

Low dose
(1024 x 512 pixels)

8. System status:

9. Value of the selected I.I. field (may be expressed in either cm or inches).

10. Available Hard Disk memory (%) to store exams.

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1.3.4 ACQUISITION

These keys let you select the recursive filter (continuous fluoroscopy) and command the horizontal or
vertical reverse of the image.

1 2 3

1. Select recursive filter.


Select by clicking on the icon again to get the required filter.
The icon indicates the selected filter (None, 2, 4, 8 or 16).

2. Command horizontal image reverse on monitor.

3. Command vertical image reverse on monitor.

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1.3.5 SEARCH

The keys in this area are for recalling acquired images.

1 2

3 4

1. Select previous run.


The system goes to the first image in the previous run.

2. Select next run.


The system goes to the first image in the next run.

3. Select previous image.

4. Select next image.

5. Command cine loop of images in current run.


This command is not active (as in the figure above) when the run contains only one image.

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1.3.6 PROCESSING

The keys in this section let you manage the «post-processing» functions for acquired images.
Each key opens a specific function window.
See the Part 2 of this manual (Use) for details of each window and function.

1 2

5 7

6 8

9 10

3 4

1. Opens the Lookup Table menu for contrast, brightness and gamma control.

2. Opens the Spatial Filter menu for selecting the spatial filter.

3. Opens the Zoom menu for selecting and adjusting the electronic enlargement of the image.

4. Opens the Overlay menu for image overwriting and graphic functions.

5. Opens the Electronic shutters menu.

6. Opens the Overview menu.

7. Opens the Harmonisation menu for the image harmonisation functions.

8. Image labeller.

9. Opens the Film Editor menu.

10. 90° image rotation (anti-clockwise).

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1.3.7 ANGIO

The keys in this section let you control the angiography exam functions.

2 1 3 4 5

6 7

1. Mask.
To use the current image as a mask and then go to subtraction mode.

2. Shifting mask.
Move the mask position to the previous image inside the run.

3. Shifting mask.
Move the mask position to the next image inside the run.

4. Image subtraction.
To go from subtraction mode to normal mode in a run where the image is being used as a
mask.

5. Pixel shift.
To enable the pixel shift function for a subtracted image in order to move the image by steps
(1/16 of a pixel or 1 pixel at a time) with reference to the mask.

6. Vascular tracing (image sum).


This command is only enabled for subtracted images.
It enables the menu needed to create a new image as a sum of the selected series of
subtracted images (see chapter 2, part 2 of this manual for details).

7. Land marking.
This command is available only in subtract mode.
This lets you view both the path of the contrast medium and the anatomical structure of the
patient in overlay mode.
You can set the percentage of overlay for the two images.

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1.3.8 MEMORY

The keys in this area let you save or transfer images.

1 2 3

1. Save command for an image during continuous and pulsed fluoroscopy and LIH image (Last
Image Hold).

2. Transfer the image on the working monitor to the reference monitor (reference image).

3. Select reference images on the reference monitor.

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1.3.9 MISC

The keys in this section let you convert the format, transfer or delete images.

1 2 3

1. Transfer the image to the network.


Command not enabled.

2. Open the Delete menu to delete the image or the entire run.

3. Open the Utilities menu to convert the image into TIFF format.
A password is required to open this menu.

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1.4 INFRARED REMOTE CONTROL (optional)

A Infrared remote control transmission led.


B Infrared remote control transmission indication.

11. Transfer image to reference monitor


12. Find reference image
13. Cine-loop
14. Reverse polarity
21, 22. Find run
23, 24. Find images
25. Save fluoroscopy image
29. Max Opacification / Road Mapping
30. Subtraction
31. Mask

A A

30 31

29 13

25 14

11 12

21 22

23 24

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1.5 DISPLAY STATION (optional)

1. Working monitor
2. Reference monitor
3. Stands
4. Handles for movement.

2
4

3 4

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2 SAFETY

2.1 INTRODUCTION

The system must be used solely in accordance with the safety instructions contained in this manual
and must never be used for purposes other than those for which it is intended.

* Since the system is to be used in combination with other equipment, full checks must be
made to assure the patients or attendant staff are not exposed to risks if there are any doubts
as to the compatibility between the system and such equipment. Contact the equipment
manufacturer or an expert.
* This system must never be used if it is faulty or any part of the overall system where the
system is installed malfunctions. Likewise, it must not be used in the event of a faulty alarm or
signal.
* Prior authorisation must be obtained from ATS before making any modifications to this
system or its safety devices.
* As with any technical apparatus, the system must be used in a proper manner and receive
regular checks and maintenance as specified in the "Maintenance" section of this manual.

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2.2 LIABILITY STATEMENT

* ATS can only be held liable for the safety of its products if the product maintenance, repair or
modification is carried out by ATS or authorised personnel of the ATS customer.
* ATS cannot be held liable for any malfunction, damage or danger resulting from improper use
of the system or from non-observance of the maintenance regulations.
* The user of the equipment fitted with the system has sole liability for checking that the system
is used solely by duly trained and qualified personnel.

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2.3 CONFORMITY AND REFERENCE STANDARDS

The system is produced by:

ATS Applicazione Tecnologie Speciali srl


via A. Volta, 6
24060 Torre dè Roveri (BG)
ITALY
TEL. +39/035584311 FAX +39/035580220
e-mail: sales@atsmed.it

The system conforms to the CE norms. The norms applicable are:

EN 60 601-1 (1990) + [A1 + A11 + A12 (1994)] + A2 (1997) + A13 (1997)


EN 60 601-1-2 (1993).

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2.4 SAFETY PROCEDURES

2.4.1 ELECTRICAL SAFETY

* The X-ray equipment fitted with the system must not be used in explosive conditions.
* Unplug the equipment before cleaning, disinfecting and sterilizing it.
* Cleaning and disinfecting products, including those used for patients, can form explosive gas
mixtures. Therefore, only use products that comply with the relevant safety regulations.
* Take care not to spill conducting liquids on the equipment as these could infiltrate and so damage
the equipment and render it unsafe to use.

2.4.2 IONISING RADIATION PROTECTION

Before carrying out any exposure, make sure that all the necessary radiation protections have been
activated.

During X-ray use, the personnel present in the X-ray room must observe the radiation protection
regulations in force. The following rules apply here:

* Where necessary, use radiation protection accessories.


* Use the special radio-protective suits. A radio-protective material equivalent to 0.35 mm of lead gives
99.95% protection against radiation of 50 kV and 94.5% protection against radiation of 100 kV.
* Distance is the best protection against radiation: always keep as far away from the source of the
X-rays and the exposure objective as possible.
* Avoid moving or remaining within the X-ray trajectory.
* Always set the smallest exposure field possible by closing the collimator diaphragms. In fact,
dispersed radiation depends to a large extent on the volume of the irradiated object.

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2.5 RESIDUAL RISKS

The system has been designed and built in full respect of the safety regulations.
Nevertheless, there are still some risks involved in the use of this system if it is used incorrectly or the
prescribed safety devices are faulty.

Risks owing to the improper use of the equipment: see the instructions and recommendations in
paragraphs 2.1 and 2.4 of this chapter.

Note also that:

- The monitor stand has been tested to guarantee that it does not tip over on sloping floors up to 10°.
* Never place the stand on floors that slope by more than 10°.
* Take special care to avoid obstacles (e.g. cables and steps) when moving the stand.

- The system used to fix the I.I. unit has been designed to bear the weight of the unit.
* Never add other accessories which can increase the load on the stand.
* Never lean on the I.I. unit.

Risks owing to defects in the prescribed safety devices: bear in mind that:

- Protection against electric shocks is provided by means of an efficient earth system for all metal
parts covering the equipment.
* The earth circuit (for both internal and external parts) should therefore be checked for
efficiency on a regular basis (see the “routine maintenance” schedule in chapter 3 of part 2
of this manual).

- The monitor screen has been tested against the risk of implosion in line with current UL norms.
* Even so, if the TV screen is hit hard enough, it may shatter with the dispersal of flying
shards of glass, dust and toxic gas.
Avoid hitting the monitor with any object.

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2.6 INDICATIONS

2.6.1 SYMBOLS

The symbols used for the commands on the display and the infrared remote control are described in
paragraphs 1.3 and 1.4.
Other symbols used as icons when a specific menu appears are described in part 2 of this manual
(“Use”).

2.6.2 ALARM MESSAGES

a) STATUS MESSAGES (CONTROL STRIP)

The status window (working frame control strip) shows two types of information:

1. system status
2. system alarms.

The two tables below list the various messages and explanations if not obvious.

n. Status message Meaning

1 EXAM NOT OPENED


2 READY Main controller connected. System in stand-by.
3 FLUOROSCOPY
4 HC PULSED FLUORO
5 RAD PREP X-ray command button pressed once: preparing for radiography.
6 READY FOR RAD Radiography mode selected.
7 DIGITAL RAD X-ray command button pressed a second time: X-ray emission for
fluorography.
8 TOMO PREP X-ray command button pressed once: preparing for tomography
9 READY FOR TOMO Tomography preparation completed
10 DIGITAL TOMO X-ray command button pressed a second time: X-ray emission for
tomography
11 CINE MODALITY Cine mode selected.
12 DIGITAL CINE X-ray emission for cine.
13 ANGIO-STEP WITH EXAM Angio-step mode selected from accessory, byut no exam has been
CLOSED opened.
14 READY FOR ANGIO-STEP

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n. Alarm message Meaning Action

1 - 15 V FAULTY Contact technical service.


2 + 15 V FAULTY Contact technical service.
3 + 24 V FAULTY Contact technical service.
4 FLUORO ORDER ON Pedal blocked or enabled but Release the scopy pedal.
the system is not ready. If the alarm persists, contact
technical service.
5 RAD SWITCH ON Graphy command button Release the graphy pedal.
blocked or enabled but the If the alarm persists, contact
system is not ready. technical service.
6 IRIS FAULT Iris fails to reach the right Repeat exposure.
position If the alarm persists, contact
technical service.
7 FILTER FAULT Optical filter fails to reach the Contact technical service
right position
8 MAN X-RAY STOP Graphy command button Repeat exposure, if necessary.
released before set time.
9 MAX RAD TIME Graphy time > 1 s Increase kV/mA for radiography
10 ACQUISITION FAULT Repeat exposure.
If the alarm persists, contact
technical service.
11 WRONG EXPOSURE Repeat exposure increasing the X-
ray data.
If the alarm persists, contact
technical service.
12 GENERATOR OFF LINE X-ray generator not enabled. Contact technical service.
13 PHOTOSENSOR FAULT Contact technical service.
14 RX DATA TOO LOW Graphy settings are too low. Increase fluorography settings.
15 RX DOSE TOO LOW Scopy settings are too low. Increase fluoroscopy settings.
16 TOMO WRONG SELECTION Tomography cannot be Quit angiography or cardiovascular
selected in angiography or mode.
cardiovascular mode.
17 STEP OUTPUT FAULT Incorrect behaviour of the Contact technical service.
signal for accessory stepping
18 SET HIGH RESOLUTION Message appears during Select 1kx1k matrix
setup
19 SELECT CONTINUOUS Message appears during Select continuous fluoroscopy mode
FLUOROSCOPY setup
20 SELECT PULSED Message appears during Select pulsed fluoroscopy mode
FLUOROSCOPY setup
21 CONSOLE OFFLINE CAN / remote console Check connection cable
connection interrupted
22 SERIAL LINK FAILURE PID processor fails to respond Check connection cable
to serial messages

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b) MESSAGES IN THE IMAGE AREA

The monitor displays any error messages in the centre of the image during acquisition and post-
processing.
The table below lists these messages by type.

n. Error message Meaning / Action


- data exchange with console
1 CONSOLE PARAMETER ERROR Invalid anatomic technique code
2 CONSOLE PARAMETER ERROR Invalid num card
3 CONSOLE PARAMETER ERROR Invalid fluoroscopy technique

4 CONSOLE PARAMETER ERROR Invalid fluoroscopy rate


5 CONSOLE PARAMETER ERROR Invalid fluoroscopy dynamic range
6 CONSOLE PARAMETER ERROR Invalid rad technique
7 CONSOLE PARAMETER ERROR Invalid rad sequence value
8 CONSOLE PARAMETER ERROR Invalid rad rate
9 CONSOLE PARAMETER ERROR Invalid rad dynamic range
10 WARNING: Parameter from console are incorrect Please release pedal

n. Error message Meaning / Action


- CCD card (inside PC)
1 WARNING: CCD FAILURE Faulty Digital Correction board Please call Image camera test not correct.
technical service Call Technical service.
2 WARNING: TV Camera fault TV camera error warning
3 WARNING: Acquisitions Format Not Available

n. Error message Meaning / Action


- data input in exam mode database
1 WARNING: ”Lut Level” + ”Lut Window” is more than 4096

n. Error message Meaning / Action


- acquisition mode
1 WARNING: Max Opacity acquisition not completed
2 ERROR: NO EXON Please release pedal
3 WARNING: DISK FULL Please release pedal
4 ERROR: GRAB FAILED Please release pedal

n. Error message Meaning / Action


- no HW key
1 Hardware key fail

n. Error message Meaning / Action


- patient data input
1 Invalid Birth Date use dd-MMM- yyyy syntax (Ex: 2 Jan 1959)

n. Error message Meaning / Action


- Archive/Exam/Run/Image structure
1 Archive already exists ! Enter a new archive name
2 Invalid password

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n. Error message Meaning / Action


- print manager
1 Operation not allowed in current state

n. Error message Meaning / Action


- external memory management
1 Acquisition disabled on removable media
2 On removable disk you can create only one archive placed in the root
directory

n. Error message Meaning / Action


- disk full
1 WARNING: DISK IS GETTING FULL Disk is getting full.
Prealarm level 1 reached: less than 200 MB
free.
2 WARNING: DISK FULL Disk is getting full.
Please end the acquisition. Prealarm level 2 reached: less than 100 MB
free.
We recommend you to stop acquisition.
3 WARNING: DISK FULL Disk is full.
ACQUISITION HALTED BY THE SYSTEM Please release pedal. Prealarm level 3 reached: Less than 50 MB
free.
Acquisition not permitted.

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3 APPENDICES

3.1 ATS COMMAND CONSOLE

Attention: The command console is optional.


If the console is fitted, the commands can be activated from either the console or the
monitor (using the mouse).

The ATS console consists of a graphic display and a series of command keys split into 3 groups:

A Function and operating mode keys

B Acquisition frequency keys

C Post-processing keys

C: Post-processing function keys

B: Acquisition frequency keys

GRAPHIC DISPLAY

A: Operating mode keys

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3.1.1 PUSHBUTTON PANEL

7, 8 33 9, 10 11 12

13

14

15, 16

17, 18

1 19, 20
2
3
4
5 21, 22
6
23, 24

32 31 30 29 27 26 25
28

1. Normal / low dose fluoroscopy


2. Continuous fluoroscopy / pulsed HCF
3. Dose correction during fluorography
4. Dose correction during fluorography
5. High resolution / low resolution for graphy and cine
6. Automatic / manual dose control during graphy
7, 8. Acquisition frequency during pulsed HCF
9, 10. Acquisition frequency during fluorography
11. Image transfer to reference monitor
12. Find reference image
13. Cine-loop
14. Reverse polarity
15, 16. Contrast control
17, 18. Brightness control
19, 20. Edge enhancement
21, 22. Find run
23, 24. Find images
25. Save fluoroscopy image
26. N.U.
27, 28. N.U.
29. Max Opacification / Road Mapping
30. Subtraction
31. Mask
32. Lock in
33. Graphic display

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3.1.2 DISPLAY

3 1 2 4 5

15

11 6

12 7

13 14 10 9 8

1. Exam number.

2. Exam type: skeleton

paediatrics

contrast

angiography

cardiovascular

3. Indication: Injector selected

4. Indication: Lock in activated

5. I.I. field.

6. Graphy mode: standard

cinematography

tomography.

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7. Acquisition speed during graphy / cine.

8. Dose control mode during graphy: manual

automatic

9. Acquisition matrix during graphy / cine: 1024x1024

512x512.

10. Graphy black correction (± 15% per step):


Total black.

11. Fluoroscopy.

12. Acquisition speed during pulsed fluoroscopy.

13. Fluoroscopy dose: low dose

normal dose

14. Fluoroscopy type: pulsed

continuous.

15. Status and alarm messages.

Note: If the console is inactive for several minutes, the display will automatically go to energy saving
mode. Simply press any console key to start again.

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Part 2: USE

LIST OF CONTENTS

page rev. date

CONTENTS I.1 to I.2 0 15/07/03

1 INSTRUCTIONS FOR USE


1.1 Introduction 1.1-1 0 15/07/03
1.2 Power up 1.2-1 0 15/07/03
1.3 Opening an archive 1.3-1 to 1.3-2 0 15/07/03
1.4 Opening an exam 1.4-1 to 1.4-3 0 15/07/03
1.5 Select exam type 1.5-1 0 15/07/03
1.6 Continuous fluoroscopy 1.6-1 0 15/07/03
1.7 Road Mapping 1.7-1 0 15/07/03
1.8 Pulsed fluoroscopy 1.8-1 0 15/07/03
1.9 Fluorography 1.9-1 0 15/07/03
1.10 Angiography exam 1.10-1 to 1.10-4 0 15/07/03
1.10.1 Programmed sequence function
1.10.2 Angio step function
1.10.3 Enable injector start function
1.11 Cardiovascular exam 1.11-1 0 15/07/03
1.12 Tomography 1.12-1 0 15/07/03
1.13 Saving an image 1.13-1 0 15/07/03
1.14 Reference images 1.14-1 0 15/07/03
1.15 Recalling an image 1.15-1 0 15/07/03
1.16 Deleting an image 1.16-1 0 15/07/03
1.17 Cine loop 1.17-1 0 15/07/03
1.18 Closing the exam 1.18-1 0 15/07/03
1.19 Ending the session 1.19-1 0 15/07/03

2 POST-PROCESSING
2.1 Introduction 2.1-1 0 15/07/03
2.2 Electronic shutters 2.2-1 0 15/07/03
2.3 LUT correction 2.3-1 to 2.3-2 0 15/07/03
2.4 Spatial filters 2.4-1 0 15/07/03
2.5 Harmonization 2.5-1 0 15/07/03
2.6 Overview 2.6-1 0 15/07/03
2.7 Image enlargement 2.7-1 0 15/07/03
2.8 Graphics 2.8-1 to 2.8-5 0 15/07/03
2.9 Image labelling 2.9-1 0 15/07/03
2.10 Image rotation 2.10-1 0 15/07/03
2.11 Angiography functions 2.11-1 to 2.11-2 0 15/07/03
2.12 Printing devices 2.12-1 0 15/07/03

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3 MAINTENANCE
3.1 Routine maintenance 3.1-1 0 15/07/03
3.1.1 Checks and inspections by the user
3.2 Cleaning and disinfecting 3.2-1 0 15/07/03

4 APPENDICES
4.1 Create new archive 4.1-1 0 15/07/03
4.2 Font management 4.2-1 0 15/07/03
4.3 Fixed strings 4.3-1 0 15/07/03
4.4 Hospital Name 4.4-1 0 15/07/03
4.5 Image transfer to DICOM network 4.5-1 to 4.5-9 0 15/07/03
4.5.1 Dicom Fast menu
4.5.2 Dicom menu
4.5.2.1 Film Editor
4.5.2.2 Show Spooler
4.5.3 Transfer of images in overview mode
4.6 Work List 4.6-1 0 15/07/03
4.7 Removable “JAZ” archive 4.7-1 to 4.7.3 0 15/07/03
4.7.1 Image archiving
4.7.2 Opening an archive
4.8 Removable “CD” archive 4.8-1 to 4.8-3 0 15/07/03
4.8.1 Image archiving to CD
4.8.2 Importing images from CD archive
4.9 Patient list management 4.9-1 to 4.9-3 0 15/07/03
4.9.1 Re-order list
4.9.2 Find exam
4.9.3 Select exams
4.10 General system checks 4.10-1 0 15/07/03

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1 INSTRUCTIONS FOR USE

1.1 INTRODUCTION

The alphanumeric keyboard and the mouse let you control the whole system via the windows on
the monitor.

Each function can be selected using either the mouse or the keyboard and is then enabled in one of
the following ways:
- by using the ENTER key on the keyboard,
- by using the OK confirmation key in the relevant monitor window,
- by double-clicking the function key displayed on the monitor.

When a function in one of the monitor menus is enabled, it is displayed bold.


Faint keys are not enabled.

This chapter and the following one contain all the instructions you need to use the system. There are
basically 3 stages:

Opening a new exam

X-ray emission and image acquisition

Image post-processing.

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1.2 SWITCHING-ON

Use the switch on the console to switch the system is on.

The monitor shows all the various stages during boot-up until the system reaches the "main frame".

You can do the following from this main frame:


- open the FILE menu and access an existing archive or create a new one,
- open the OPTION menu and access the programming boards for technical interventions,
- open the HELP menu and check the number of the installed software release.

Attention: Since there's the residual risk of X-ray emission for the patient, we recommend carrying
out a series of checks every day immediately after switching the system on and before
starting to scan the patient: these tests are aimed at checking the efficiency of the
system. See Appendix 4.9 (“General System Check”) in this section of the manual for
details of the test procedure.

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1.3 OPENING AN ARCHIVE

Files can be opened from the MAIN FRAME in 2 ways:

- by clicking directly on the


“Open Archive” icon

- by opening the FILE menu


(select “Open Archive”).

In either case, the “Archive List


Manager” window is displayed in the
MAIN FRAME, listing all the archives.

Press the Remove key to delete a file


from the list;
press the Browse key to view
archives not included in this list.

Select the archive you want and then confirm (click with the mouse or press Enter) to open it: the
corresponding patient list appears.

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To move from one archive to another, close the current archive using the Close function in the File
menu.

You thus return to the MAIN FRAME and so can open another archive in the usual way (see above).

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1.4 OPENING AN EXAM

When you open an archive, the patient list appears (see figure in previous paragraph).

Now you can:

· select an existing patient exam for post-processing of the images, change the exam
data or make new acquisitions and add these to the exam;

· open a new patient to make a new exam.

· Existing patient:

Select the patient which becomes highlighted.

Note: If the archive contains a long patient list, it's useful to re-order the list or use the search function
when it comes to finding the exam you want. See Annex 4.10 in this part of the manual.

Open the “Working frame” of the exam you want by double-clicking on the name of the exam or
pressing ENTER.
See the “Post-processing” chapter further on in this part for details.

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To change the exam data, select “Modify Exam Data” from the “Exam” menu.

For details of the “Exam Data” frame, see below (“New Patient”).

· New patient:

To open a new patient you must first select the archive you want to store it in.
To do this:

- Click on the “New Exam” icon in the “Exam”


menu from the patient list frame.

- The “Exam Data” frame opens above the patient


list frame.

- Enter the data* as required and then confirm with OK.

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You now return to the patient list which will include the new patient at the top of the list: select this in
the same way as for an existing patient (see “Existing patient” above).

The patient list contains all the data (except for “Exam Data” parameter ID, used to identify the exam
being transmitted on the DICOM network), while the working frame only indicates the “Patient Data”
group and the “Physician”.

* The fields “First Name” e “Family Name” will only accept data totalling max 60 characters.

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1.5 SELECT EXAM TYPE

1 Use the main menu in the command strip to open the exam type list (1) and then select the type
you want.

2 Open the list of the preset exam cards (2) and then select the one you want.

1: exam type

Exam Skeleton
Paediatrics
Contrast
Angiography
Cardiovascular

2: exam card

Lock-in not used

Note: - When you select an exam card with active lock-in, the relevant icon appears in the window.
- The choices made (exam type and card) are also shown in area (3) of the working frame,
together with the other acquisition data.

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1.6 CONTINUOUS FLUOROSCOPY

· Use the “Acquisition Setup” menu in the command strip to select continuous fluoroscopy mode (1).

· Then select the dose level: normal dose, with acquisition matrix 1024x1024, or low dose, with
matrix 1024x512 (2).

1 2

1: fluoroscopy mode 2: dose level

normal dose
(1024 x 1024 pixels)
continuous
fluoroscopy low dose
(1024 x 512 pixels)

· Give the fluoroscopy command using the relevant pedal.

The word FLUOROSCOPY appears on the display in the message window (3);
TC:FL appears in the image frame on the monitor and at the end of fluoroscopy, Last Image
Hold..

· You can save the LIH using the appropriate key in the “Memory” menu (4)
(otherwise it is lost with the next X-ray command).

· You can use this same key (4) to save images during X-ray emission in fluoroscopy mode.
.
· During acquisition, the commands in the “Acquisition” area are enabled so you can select the
recursive filter (5) (options: none, 2, 4, 8, 16) and reverse the image (6) and (7).

5 6 7

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1.7 ROAD MAPPING

The Road Mapping function is only available in angiography mode and so is only possible for the
system with D.S.A. software (optional).

The Road Mapping function lets you save the max. opacification pixel by pixel and so trace the
passage of the contrast liquid as it flows through the vessel, even once it has become fully diluted.
This image can then be used as a mask so that, on displaying subtracted images, you can monitor the
introduction of a catheter in the vessel, even after the contrast liquid has disappeared.

· Select continuous fluoroscopy and Road Mapping (the low resolution mode is automatically
selected).
· Your selection is indicated in the image frame with a flashing marker.

Angio exam

Fluoroscopy with
Road Mapping

· Give the fluoroscopy command and inject the contrast medium into the artery. The system saves
the trace created by contrast medium after 1.65 seconds, thus creating the image called “Max.
Opacification”.

· Again give the fluoroscopy command and the system carries out the Road mapping function,
displaying on the monitor the result of the subtraction of the live image and the Max. Opacification
image: the artery with the contrast medium shows up as «white», while the catheter is «black».

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1.8 PULSED FLUOROSCOPY

· Use the “Acquisition Setup” menu in the command strip to select pulse fluoroscopy mode (1).

· Then select the dose level: normal, with acquisition matrix 1024x1024, or low dose, with matrix
1024x512 (2).

· Select the acquisition speed (3).


The images will only be automatically saved if this option has been set in the selected acquisition
card.

The set speeds (in “images / second”) are:


0.5 1 2 3 6 10 15 30.

1 2

1: pulsed 2: dose level 3: speed acquisition


fluoroscopy

normal dose

low dose

· Give the fluoroscopy command and the word H.C.


FLUORO appears in the message window, while TC:PL
appears in the image frame.

· If you have not selected automatic saving of the images,


single images can still be saved (during X-ray emission or
and the last image).
Use the save appropriate key in the “Memory” menu (4).
4

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1.9 FLUOROGRAPHY

· Select the fluoroscopy dose control mode (1):


- if you select automatic control, you must set a back-up time on the X-ray generator longer than
the one calculated by the system (otherwise the exposure or series of exposures will be
interrupted and the "WRONG EXPOSURE" alarm will appear).
- select manual control and you can set an exposure time on the X-ray generator shorter than the
one calculated by the system, without the "WRONG EXPOSURE" alarm.

· Select the acquisition speed (2)


Options: single, 0.5 i/s, 1 i/s, 2 i/s, 3 i/s, 6 i/s, 10 i/s, 15 i/s, 30 i/s.
The 30 i/s option is only possible in low resolution mode: select the relevant mode (3).

3
2

1: dose control 2: acquisition speed 3: resolution

automatic
high resolution
control
(1024x1024 pixels)

manual
control low resolution
(512x512 pixels)

· Give the fluorography command with the relevant button. The words READY FOR RAD will
appear in the message window on the monitor and then DIGITAL RAD (on pressing the button a
second time), while TC:RX appears in the image frame.

Note; If the “LOCK IN” function (4) is enabled in the selected exam card, the exposure time is
rd
calculated from the 3 exposure and then kept constant throughout the sequence,
regardless of any subsequent changes in opacity.

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1.10 ANGIOGRAPHY EXAM

Attention: The angiography functions are optional and are only available if the system has the relative
D.S.A. software.
N.B.: Also the Road Mapping function (see point 1.7) is part of the angiography function.

· Select the angiography exam type (1) and exam card (2) as explained in paragraph 1.5: an icon
(3) shows if the “Lock in” function is enabled in the exam card.

3 2

· Select the acquisition speed (4); there are the same speed options as for “standard” fluorography
(see previous paragraph).
4: speed control: in high resolution in low resolution

· Give the fluoroscopy preparation command with the relevant button, followed by the X-ray
command.
st
The words READY FOR RAD appear in the message window on the monitor (1 time you use
nd
the key) and then DIGITAL RAD (2 time), while TC: RX appears in the image frame.

To change the mask during the angiography exam, simply press the relevant key (5).

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1.10.1 PROGRAMMED SEQUENCE FUNCTION

This function lets you carry out an exam in angiography with a variable acquisition rate during the
exam.
Up to separate 10 phases can be programmed for each exam, selecting the duration and associated
acquisition rate for each of these.

Note: - The angiography function with programmed


sequence is set in each exam card. 6
- The relevant icon (6) appears on the monitor
when you select a function with a programmed
sequence.

To set the phases in the programmed sequence, select the Option / Acquisition Setup menu (from
the Patient List or when the archive is closed) in order to open the Acquisition Setup menu shown
below.

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Now select the Rad card (shown in the figure above) and set the Sequence/Rate field.

“Sequence/Rate” field

This lets you set a sequence of acquisitions in RAD mode, with a fixed acquisition rate, with either a
programmed sequence (max 10 steps) or an “Angio step” sequence.

· Default Rate, tick (ü) to enable the open exam function with Default acquisition
speed (the actual speed is set in the box next to this).

· Sequence Enable, tick (ü) to enable the “programmed sequence” function.


· Phase, description of the phases in the programmed sequence:
· Rate, acquisition rate during steps
(the rates are the same as those for fluorography, 0.5 - 30 i/s).
· Time, time in ms between acquisitions (e.g.: 4000 = step lasting 4 s).

Note: The steps advance automatically at the end of the relevant set
time until the first step where “time = 0”. At this point, the system
continues acquiring images at the rate set here until the
acquisition command is released.

1.10.2 ANGIO STEP FUNCTION

This function consists of a special angio acquisition sequence that synchronises the system and the
accessory so that the accessory advances by one step at the end of each programmed sequence.

The function is set from the accessory console when the system is in standby mode: the relevant icon
(7) automatically appears on the monitor.

See paragraph 1.10.1 above for details of how to program the ANGIO STEP sequence.

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1.10.3 ENABLE INJECTOR START FUNCTION

This function lets you set the moment the injector starts with respect to the start of acquisition.

To do this, use the Injector field in the RAD cards in the Technics Cards Setup menu (see figure
above in paragraph 1.10.1).

“Injector” field

There are 2 options for programming:

· Enable injector, tick (ü) to enable the function.


· Injector Delay, time in ms to anticipate/delay the start of the injector compared to the
start of acquisition (e.g.: -2000 = anticipate injector start by 2 seconds
compared to acquisition start).

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1.11 CARDIOVASCULAR EXAM

Attention: The cardiovascular function is optional and so is only available if the system has the
relative software.

· Select the cardiology exam type (1) and number (2) as explained in paragraph 1.5: the system
automatically enables the “Cine” function (3).

· Select the resolution type (4): high (acquisition matrix 1024x1024) or low (matrix 512x512).

· Select the acquisition speed (5).


The possible speeds are: 15 i/s, 30 i/s, 60 i/s.
Note: Acquisition rate 60 i/s is only available with low resolution.

3 4

· Give the fluoroscopy preparation command with the relevant button and then the X-ray command.
st
The words CINE MODE appear in the message window on the monitor (1 time you press the
nd
button) and then DIGITAL CINE (2 time), while TC: CN appears in the image frame.

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1.12 TOMOGRAPHY

The tomography function is selected from an peripheral appliance which sends the relevant signal to
the system.

The monitor indicates the tomography mode with the relevant icon (1).

Give the tomography command with the relevant button:


- the words READY FOR TOMO appear in the message window on the monitor first;
- on pressing the button a second time, the words RX DIGITAL TOMO appear.

Note: - Max exposure time in tomography mode is 2.5 seconds.


- The tomography mode is not available if either the ANGIOGRAPHY or CARDIOVASCULAR
exam mode has been selected.

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1.13 SAVING AN IMAGE

· All the fluorography images (including tomography and cinematography images) are
automatically saved to the hard disk.

· Continuous fluoroscopy images are not automatically saved to the hard disk.
The images can be saved by using the buttons in the "Memory" area (1) or the remote control.

· In pulsed HCF fluoroscopy mode, you can choose, in set-up, whether to save all the images
automatically or save them yourself as with the continuous fluoroscopy images.

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1.14 REFERENCE IMAGES

The image shown on the working monitor can be sent to the reference monitor in order to create a
reference image.

To do this, use either the relevant key in the “Memory” area of the control strip or the one on the
remote control.

Transfer to reference monitor

You can create up to 8 reference images.


The presence of a reference image is indicated by a marker in string of 8 boxes (see figure below).
If 8 reference images already exist (all 8 boxes contain a marker), a new image will take the place of
the oldest one.
The oldest image is indicated by a cross within its box.

casella.

Numbering
of reference images

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1.15 RECALLING AN IMAGE

To recall one of the images saved on the reference monitor, you can use the relevant key in the
"Memory" area.

Find reference image

To recall an image in a given exam, use the relevant keys in the “Search” section of the control strip.

Find run

Find image

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1.16 DELETING AN IMAGE

The deletion key is in the «Misc» section of the working frame control strip.
When you click on this key, a window appears asking you if you are sure you want to delete the
image or the whole run.

Confirm delete image

Confirm delete run

Cancel (quit)

You can also delete the whole exam.


To do this, open the “EXAM” menu in the “Archive” frame and then select “Delete Exam(s)”. You can
now delete the exam(s) you have selected in the archive list.

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1.17 CINE LOOP

The “Cine loop” function lets you display all the images in a given run in chronological order.
The rate at which the images are displayed is the same as the acquisition rate (i.e., min. 1 i/sec. and
max. system speed).

To enable this function, press the relevant key in the “Search” section or on the remote control strip.

Note: During installation, you may set up the system to get automatic activation of the “Cine loop” at
the end of acquisition in CARDIO mode.

Command cine loop

To stop this function, press the same key on the console or the remote control; alternatively press the
Stop Cine Loop key in the working frame control strip.

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1.18 CLOSING THE EXAM

When you have finished the exam:

· Go to the patient list frame by clicking on the relevant icon in the main menu of the control strip.

Archive (Patient List)

· Use the Close command in the FILE menu (patient list frame) to return to the MAIN FRAME.

Close archive

To start a new exam, see paragraph 1.4 above (“Opening an exam”).

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1.19 ENDING THE SESSION

To close all exams and shut down the system, follow these steps:

· Open the Shut Down Windows menu from the MAIN FRAME using the icon
and then use the Shutdown command to shut down the system.

· This way all the programs will close and you can simply switch off the system using the main
switch at the rear of the console.

Warning: Before switching off the system, wait for all the applications to be closed and the
message of consent.

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2 POST-PROCESSING

2.1 INTRODUCTION

All the post-processing functions can be enabled via the keys in the “Processing” section of the
working frame control strip.
The reverse image polarity can also be enabled via the remote control.

Unless otherwise specified, each function changing the image display parameters is applied to the
entire run containing that image.

Post-processing functions

The Delete, Search image and Cine loop functions (available in post-processing) are not described
below as these have already been described in the previous chapter.
The Film Editor function is described in paragraph 4.5.2.1.

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2.2 ELECTRONIC SHUTTERS

The electronic shutters are enabled via the keys in the “Shutters Manager” menu found in the
“Processing” section of the working frame control strip.
There are 2 types of shutter: square and circular.

Square shutter (Square icon):


- Click on the square shutter icon to enable this function.
- Go to the image field and take the pointer to the image you want to shutter.
- Drag the mouse to frame the portion of the image you're interested in.
- Release the left-hand mouse button to shutter the image (now centred on the screen).

Circular shutter (Circular icon):


- Click on the circular shutter icon to enable this function.
- Go to the image field and take the pointer to the centre of the section of the image that you want to
shutter.
- Drag the mouse so that the portion of the image you want is enclosed in a frame.
- Release the left-hand mouse button to shutter the image (now centred on the screen).

Search last / next run

Insert square shutter

Insert circular shutter

Quit
with shutter
Quit
without shutter

Note 1: A shutter applied to one image is automatically applied to all images in the same run.

Note 2: Click on the image to delete the shutter.

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2.3 LUT CORRECTION

The system lets you change the look of saved images.

· In particular, the system lets you change the following parameters:

- Brightness (level)
- Contrast (window)
- Gamma: variation range = -10 to +10 (we recommend 0).

The brightness and contrast controls (level and window) affect each other and are shown in the
relevant window.

· The system also allows for:

- Reverse image polarity.


- Application of a contrast and brightness linear curve.
- Application of the linear curve to the “video output / video input” ratio (gamma).
- Selection of the gamma correction curve type (we recommend using the “Normal” curve).
- Application of the autohistogram function, i.e., application of the various optimal contrast and
brightness values depending on the contents of the image (see note *).

These functions and settings can be enabled using the keys in the
“LOOKUP MANAGER” menu in the “Processing” section of the
working frame control strip (see figure below).

Correction curve applied

Correct contrast (window)

Correct brightness (level)

Correct gamma

Select gamma correction curve type: Normal


Thorax 1
Thorax 2
Thorax 3

Activation linear gamma ratio

Reverse image polarity

Enable linear curves

Enable automatic correction

Quit wth original values

Quit With new values

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The “OK” key is used to quit the function and:


- if used with a saved image, it assigns the set values to all images in that run;
- if used with a LIH image, it assigns the set values for the entire exam.

The “OK” key can also be used during fluoroscopy acquisition. In this case, the set values
apply for the entire exam.

Use the “Cancel” key to undo any selections.

Note *: You can change the value of the area used to calculate the automatic contrast and brightness
correction using the General Settings menu (described in the technical manual).

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2.4 SPATIAL FILTERS

The system lets you apply different types of filter to the acquired images.

These filters are enabled using the keys in the “Spatial Filter Manager” menu in the “Processing”
section of the working frame control strip.

Filter: NONE
SHARP
SMOOTH

Kernel: 3x3
5x5
7x7
9x9
11x11

Weight: 1
2
3
4
5

Use the “Filter” key to select the filter type (NONE = «no filter»).

Use the “Kernel” key to select the size of the processing matrix to be used by the filter.

Use the “Weight” key to select the processing level.

Use the “Apply” key to apply the selected filter to a single image on the monitor.

The “OK” key to quit the function and:


- if used with a saved image, it assigns the filter to all images in that run;
- if used with a LIH image, it assigns the filter to the entire exam.

Use the “Cancel” key to undo your selection.

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2.5 HARMONIZATION

The harmonization function is enabled via the “Harmonization” menu in the “Processing” section of the
working frame control strip.

This image processing made possible by this function consists of a variable filter that improves the
local contrast of areas containing different information.
The menu lets you set the type and level of the processing operation:

- Type: Horizontal
Area
None (i.e., “no function enabled”).

- Level: High
Low.

Use the “Apply” key to apply the harmonization function to the live image on the monitor.

Use the “OK” key to confirm the parameters and quit the function.

Use the ”Cancel” key to quit the function, undoing any changes.

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2.6 OVERVIEW

The overview of the saved images function is enabled via the “Overview” menu in the “Processing”
section of the working frame control strip.

This function lets you obtain an overview of a series of images from the current image onwards.
You can set the number of images you want to display in overview (see figure).

The “Search” keys are enabled during this function:


- the find image keys let you view the previous or next group of images in the selected run;
- the find run keys let you view the very first image in the previous or next run.

The overview images are identified by the number of the run and the sequence order (e.g. , image
number 2-5 = the 5th image in the 2nd run in that exam).

The mouse can be used to select an image in the overview, (or more than one, by pressing the Ctrl
key) and:
- label image
- select mask
- delete image.

On quitting the overview function (Exit),


the monitor will display the last selected
image.

The figure shows an overview with


4 images.

Find run

Find image

Label image

Delete image
Select overview: 4
9
Mask 16
1+5
1+7

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2.7 IMAGE ENLARGEMENT

The image can be enlarged using the “Zoom Manager” menu in the “Processing” section of the
working frame control strip.

This function lets you have electronic enlargement of the image on the monitor in two ways:

- Zoom mode: using the mouse pointer (which becomes two concentric squares, as shown on the
relevant icon), select the section of the image you want to enlarge. Release the
mouse key and the image is enlarged.

- Lens mode: using the mouse pointer (which becomes a lens), select the centre of the section
of the image you want to enlarge. Release the mouse key and the image is
enlarged by 100x100 pixels.

Both modes have a variable enlargement factor of 1.2 to 3. Use the Zoom Factor cursor to select the
enlargement rate (indicated at the side of the image).

On quitting the function, the image returns to its original size.

Zoom mode

Zoom Factor status

Lens mode

Select Zoom Factor

Zoom Factor status

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2.8 GRAPHICS

The system lets you overwrite the text and measure the images.
The relative functions are enabled via the “Overlay” menu in the “Processing” section of the working
frame control strip.

Angle

Text Stenosis

Grid Calibration

Statistics Ruler

Arrow
Frame
Delete

Select
Delete calibrate

Quit Quit
without graphics with graphics

The functions in the Tools section are:

Text:

This lets you overwrite an image.


· Click on the function key.
· Drag the pointer to the area of the image where you want to add some text.
· Click again to open the text area.
· Enter the text and then confirm (with the Enter key on the keyboard, or the OK in the Dialog
menu).
· You can then select the text and drag this to another point in the screen.
· Double click to highlight the text and then edit it.

You can also add a fixed text from a list called “Add Fixed String”:
· Right click the position where you want to add the text: the list pops up (see paragraph 4.3 below
for details of the list).
· Choose the text and then left click to confirm.

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· You can then select the text, drag this to another point in the screen and edit it.

Angle:

This lets you measure the angles in an image.


· Click on the function key to activate the pointer used to measure the angle.
· Drag the pointer onto the image.
· Use the mouse to trace the 2 segments making up the angle: the value of the angle is
automatically displayed.
· Use the mouse to drag either end of the segments or the vertex to the body part you want to
measure. The measurement appears automatically.
· You can then select the measurement and drag this to another point in the screen.

Stenosis:

This lets you measure the percentage of stenosis.


· Click on the function key to activate the pointer used to measure the angle.
· Drag the pointer onto the image.
· Use the mouse to trace the 3 segments (a, b, c) defining the stenosis: the stenosis measurement
appears automatically, expressed as a percentage of the ratio between the size of the stenosis
and the average size of the vessel above and below this.

æa +cö
S% = b ¸ ç ÷ ´ 100 a b c
è 2 ø

· You can pick up the ends of the segments and correct the position of the body part concerned: the
measurement of stenosis is automatically updated.
· You can then select the stenosis percentage and drag this to another point in the screen.

Grid:

This lets you add a grid to the image.


· Click on the function selection key: a grid appears on top of the image, together with a sample
segment representing the unit of measurement.
· To change the size of the grid, you must change the size of the sample segment by dragging its
ends with the mouse.
· The grid can be dragged by the mouse at its corners.

Ruler:

This lets you measure the image.


· Click on the function key.
· Use the mouse to trace a segment (ruler) above the area you want to measure: the measurement
is automatically displayed in pixels.
· To get the measurement in mm, you have to calibrate the ruler, as described below.
· You can adjust the measurement of the ruler by picking up the ends of the segment and shifting
them with the mouse.
· You can also pick up the field with the value of the ruler and move it at will.

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Calibration:

This lets you set a unit of measurement for the


image.
· Click on the calibration key to open the
“Calibration Mode” menu.
· Use the mouse to drag a segment (gauge) on top of a detail
of the image whose measurement is known: the
measurement automatically appears in pixels.
· Enter the value in mm
in the menu window: all the measurements on the image
(including the gauge) are automatically displayed in mm.

This calibration setting is valid for the entire run


containing the current image.
The calibration function is not enabled for images
belonging to a run where the gauge has already
been set.
If you want to change the measurement of the
gauge, delete the existing one (see below).

There are three calibration modes:

- Free: Standard setting. This lets you trace the


gauge segment any way you want.
- Stripe: This lets you select a clear object as a
gauge by tracing the segment all around
this. The system will then define the
object in line with variations in the
contrast around the edge.
- Catheter: This lets you select a catheter as a
gauge:
- trace a transverse segment across
the catheter (the system will fix the
edges);
- enter the known measurement of the
catheter (conventional FR unit: 1 FR =
4/1.333 mm).

Calibration
in Catheter mode

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Statistics:

This function comes in handy for technicians during system


installation and maintenance.
It lets you activate the “Image Statistics” menu which detects
the position and value of the pixel in an area selected using the
mouse.

The menu fields here are:

- Selection:
to choose the field in which you want to read the values
specified in fields Position and Statistics:
- 9x9 pixel square central point
- horizontal segment
- vertical segment
- rectangle.

- Segment specific:
to select the reading window for the “moving mean”.

- Position:
to identify the position of the point, segment or rectangle
you’ve selected:
- the 9x9 square is identified by its central point
- the segment is identified by its ends
- the rectangle is identified by its opposing vertices.

- Statistics:
for the statistics of the grey value:
- value in centre
- min value
- max value
- standard deviation.

- Show graphs:
to select the graphs to be displayed:
- profile
- histogram
- moving mean
- moving standard deviation.

HIRIS A plus system only

Frame

This lets you trace a frame on the image around the area of interest.
· Click on this button to select the function.
· Drag the pointer onto the image at the required point.
· Use the mouse the trace a rectangular cornice.
· You can pick up the corners of the cornice and drag these to cover the area of interest better.

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Arrow

This lets you draw an arrow on the image.


· Click on this button to enable the function.
· Drag the pointer onto the image at the required point.
· Use the mouse the trace the arrow.
· You can pick up the corners of the arrow and drag these to cover the area of interest better.

The “Item” field has 3 function icons:

· Select

This lets you recall other graphic items (text, angles, …)


that have already been overlaid. The graphic items are
Select
recalled in the reverse order in which they have been
added. Delete

Delete gauge
· Delete

This lets you delete the last graphic item

· Delete calibrate:

This lets you delete the calibration for the entire run.

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2.9 IMAGE LABELLING

The system lets you label images of special interest so that you can recall these more easily to carry
out the required operations.

This function is activated by using the “Label” icon in the “Processing” group belonging to the working
frame control strip. A marker (see figure below) appears next to the image on the display.

To remove the label, simply repeat the command.

Label

The marker is also shown in overview mode.

If there are labelled images within a run:

- the labelled images are not deleted when you use the delete command for that run;
- only the labelled images in the run can be transferred to the network when using the DICOM-3.0
protocol.

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2.10 IMAGE ROTATION

The system lets you rotate the images 90° anti-clockwise; you can use this command several times to
rotate the image as required.

Use the relevant button in the “Processing” unit of the working frame control strip area to activate this
function.
A marker appears on the image to indicate that the image has been rotated.

To cancel the rotation, repeat the same command several times until the image returns to its original
position.

Rotation

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2.11 ANGIOGRAPHY FUNCTIONS

The angiography functions are enabled using the keys in the «Angio» section of the working frame
control strip.
Shifting mask, forward

Mask Subtraction

Shifting mask, back Pixel shift

Vascular tracing
Land marking

Mask:

This function lets you adopt the current


image as a mask and then go to subtraction Marker
mode. for mask
It is enabled in acquisition and in
post-processing.
The image used for the mask is identified by
a marker.

Shifting mask:

To shift the selected mask image on the


previous or next image inside the selected
run.

Image subtraction: SpostamentoShift


1 pixel
passi di 1 steps
pixel
To go from subtraction mode to normal
mode (and vice-versa) in a run where the SpostamentoShift
image is being used as a mask. 1/16dipixel
passi 1/16 steps
pixel

Cancel
Annullamento
Pixel shift: shift
spostamento

This opens the «Shifting Pixel» menu for a


subtracted image so that the image can be Indication
Indicazione
moved by steps (1/16 of a pixel or 1 pixel at shift
spostamento
a time) using the menu keys.

You can “filter” the subtraction by replacing


the mask, or the image, with a medium one
on the adjacent images (Mask filter and Weight
Image filter). Logarithm curve
The “Shifting Pixel” menu also lets
you change the value of the logarithm Mask filter
curve applied to subtracted images.
See the technical manual for a
Image filter
description of this function
(Log LUT Weight).

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Image sum (vascular tracing):

This function lets you create a new image as the sum of a series of subtracted images in the same
run.
This function is particularly useful when you need to trace the path followed by the contrast means
along the vessels.

The following commands are possible:

- Start block: to select the first image in a series of


images for vascular tracing.

- End block: to select the last image in a series of


images for vascular tracing.

- Add Single: to select a single image for vascular tracing.

- Remove Single: to remove a single image for vascular


tracing.

- Remove All: to remove all images for vascular


tracing.

- Execute: to enable the sum function, thus


obtaining the vascular tracing.

- Save: to starts vascular tracing and save it in


the memory, thus creating a run of
single images which is placed next to
the current run.

- Exit: to quit vascular tracing.

Land marking:

This function lets you view both the path of the contrast
medium and the anatomical structure at the same time (in
subtract mode).
You can select the % of overlay of the 2 images:
- 0% for standard subtract image (contrast medium only),
- 100% for the non-subtracted image (all the anatomical
structure is visible).

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2.12 PRINTING DEVICES

The system lets you transfer to printer:


- via DICOM protocol (network connection),
- via 3M-M959 protocol (direct printing).

Printing via network with DICOM protocol:

See point 4.5.2.1 “Film Editor” of this part of the manual for a full description of the transfer and
printing procedure.

Printing with a laser imager with 3M-M959 protocol:

The system lets you print the current image (one shot or in overview mode) on the working monitor.

Use the keyboard of the printer to select the format and use the relevant printing commands; see
the instruction manual for the specific printer for further details.

Note: All major laser imagers (AGFA, KODAK, 3M, FUJI, DUPONT and KONICA) are compatible
with the system.

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3 MAINTENANCE

Always contact the technical service and follow the instructions in the technical manual for
extraordinary maintenance, the malfunction or replacement of components.
This manual deals only with routine maintenance.

3.1 ROUTINE MAINTENANCE

The equipment needs to be checked and serviced on a regular basis. The recommendations below
are aimed at maintaining the efficiency and safety of the equipment.
Routine inspections and maintenance are also needed to protect the patients and medical staff from
the risk of injury due to malfunctions.
Correct adjustment of the electronic modules has a direct effect on the performance of the equipment,
image quality, electrical safety and the level of radiation to which the medical staff and patient are
exposed.
The maintenance plan includes checks and inspections to be carried out by the owner or his expressly
authorised staff.

Always use original parts to replace components that may affect the safety of the system.

3.1.1 CHECKS AND INSPECTIONS BY THE USER

The user must train his operators so that they can carry out the daily checks. The other checks must
be carried out by qualified staff with express authorisation from the technical service.

Daily Check the efficiency of the indications on the working monitor.


Weekly Check the integrity and fixing of all system components.
Every 6 months Carry out the Acceptance Test procedure, as described in the technical manual.
Check that the system is properly earthed.
Check the mains voltage rate.
Check the DC generated inside the system.

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3.2 CLEANING AND DISINFECTING

Do not use cleaning products that have a high alcohol content. Do not use corrosive detergents,
abrasive products or solvents.
Use only disinfectant products that fully comply with existing disinfecting and explosion prevention
procedures.

To clean and disinfect:


- Switch the equipment off and unplug at the mains.
- Make sure that no liquids infiltrate the equipment to prevent short circuits and corrosion of the
electrical and electromechanical components.

The equipment must not be used in presence of anaesthetics and/or inflammable disinfectants and
cleaning products .

If using disinfectants that form explosive gases, make sure that the gases have had time to
disperse before using the equipment again to generate X-rays.

If the user modality of the system requires the sterilisation of the device, this must be done by
the user.

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4 APPENDICES

4.1 CREATE NEW ARCHIVE

By ARCHIVE we mean the directory used to store the exams. It can be useful to use several
directories so that exams can be saved under specific criteria.
To create a new archive, follow these steps:

· Open the FILE menu in the MAIN FRAME and use the New Archive function.

New Archive

The new archive window appears:

· Enter the data required and then confirm with Save: a box now appears asking you to enter the
“Password”.

· Enter the password MedService and confirm with OK: the new archive can now be used.

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4.2 FONT MANAGEMENT

The system has a Font menu that lets you change the characters (type, size etc.) used in the menu
windows and dialog boxes on the working monitor.
To do this:

· Open the OPTION menu in the Archive frame (patient list) and use the Font function.

Font

The font window appears:

· Make the necessary selections and then confirm with “OK”.

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4.3 FIXED STRINGS

The system lets you use a list of the most commonly used texts (“fixed strings”) to speed up the writing
of words or short messages on the image.
This list can hold max. 10 texts for each type of exam plus 6 texts common to all exam types.

To create or update the list, follow these steps:

· Open the OPTION menu from the MAIN FRAME and then use the Fixed Strings Setup
command.

The fixed strings setup window appears:

· Select the area of the exam type you require or the common area (COMMON).

· Use any of these keys as required:


· Append to add the text at the bottom of the list,
· Insert to add the text in another position in the list,
· Edit to correct an existing text,
· Remove to remove the text from the list.

· Quit this function with the following keys:


· OK to confirm the changes,
· Cancel to cancel any changes.

To insert the text on the images, see the explanations in paragraph 2.8 (OVERLAY) of this part of the
manual.

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4.4 HOSPITAL NAME

The Hospital name menu can be accessed either from the patient list or when the archive is closed
by selecting OPTION / HOSPITAL NAME.
The window that appears (Hospital name) has a single field for you to enter the name you wish to
appear on both the monitor and the printout of the exam images:

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4.5 IMAGE TRANSFER TO DICOM NETWORK

The system lets you send images to a network using DICOM-3.0 protocol.
The images can be sent to workstations (Store function) or to printers (Print function).

Press the right button on the mouse to transfer images.


A dialog box appears:
- Select the Dicom Fast option for direct access to the printers or storage devices set as the default
devices during installation.
- Alternatively, select the Dicom option to select other printers or storage devices. The Dicom option
also lets you access the Dicom Spooler window, an application that manages the transmission of
images to the network.

To add text from the “fixed string” list


(see note*)

To open the main transmission menu

To open the transmission menu for


transmission to the default device

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Note *: For details of the Add Fixed String menu (to add a text already stored in the “fixed string” list
on the image), see:
- paragraph 2.8 above (GRAPHIC, Text), on how to add text on the image,
- paragraph 4.3 above (FIXED STRNGS), on how to manage the list.

4.5.1 Dicom Fast MENU

This includes the following options:

Store to store the current image.

Store Run (all) to store the entire run that the current image belongs to.

Store Run (labelled) to store all the labelled images in the run that the current image belongs to.

Store Exam (all) to store the entire exam that the displayed image belongs to.

Store Exam (labelled) to store all labelled images in the exam that the displayed image belongs to.

Print to get a printout of the current image.

Note: All storage and print operations are performed by the default device.

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4.5.2 Dicom MENU

· This menu has 2 extra archiving options compared to the Dicom Fast menu (see point 4.5.1
above):

Store Run as XA multiframe to save the entire run containing the image shown in XA
format.

Store Exam as XA multiframe to save the entire exam in XA format.

· When you select one of the storage or print options in this menu (shared with the DICOM Fast
menu), a Spooler window appears so that you can select the receiving device.

Select receiving device

Select number of attempts to transmit

Priority in the transmission queue

Select transmission schedule

Set transmission date

· See the specific paragraphs below for all other options:

Film Editor To print onto film using printers with DICOM interface para. 4.5.2.1

Show Spooler To set the parameters of the “Spooler” function para. 4.5.2.2
Create CD To store images with DICOM protocol on CD para. 4.8

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4.5.2.1 Film Editor

The Film Editor option lets you compose the printing film.

This operation can be done either from a single image (as in the figure below) or in overview mode.

- Select the menu:


- using the relevant key in the “Processing” group in the Operating Frame,
- or via mouse, right-clicking on Dicom / Film Editor.
In both cases, the film frame opens on the monitor, with the print settings menu (the “film frame” is
displayed adopting the most recently set format).

Film frame

Print menu

Search image
commands

Film frame:
set to have 3 lines x 3 columns

Print menu bar

Close: to quit the function

Expand: to open the settings window

Print All: to give the print command

- Use the Expand command to open the print settings menu (see figure below).

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USER MANUAL for series 03

Printer settings

Film format settings

Quit settings menu

- Warning: The printer settings are normally only used when installing the printer.

- Set the film format using the following options:

Custom Format: this offers you a choice of standard formats (see example in figure
below).

Film Size: this lets you choose the dimensions of the film.
For example: 8 inches x 10 inches
24 cm x 30 cm

Orientation: to print: horizontally (LANDSCAPE)


vertically (PORTRAIT)

Film Format: this let you create a personalised format:


STANDARD to select the number of images in rows and columns
ROW to select the number of images in each row
COL to select the number of images in each column

- Use the Exit command to close the print settings menu and to return to the original image frame.

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- Select the images you are interested in (using the “Search” commands and overview mode if
required) and then use the mouse to drag them to the film frame box.
The figure below shows a film with standard format “ALIAS-COL3-1-3”.

Note: - When at least one image has been inserted in the film frame, new commands appear in
the menu (see figure).
- The images are transferred to the film frame as shown on the monitor: each image can
therefore be inserted in the film several times, in different modes (zoomed, negative …).

Custom: ALIAS-COL3-1-3
Selected Box

Delete All

Delete

Print All
Print

- If necessary, you can change the layout of the images in the boxes using the following commands:

Delete: to delete a single image in the selected box from the film.

Delete All: to delete all the images.

- To start printing, use the following commands:

Print: to print just the image actually shown.

Print All: to print all the images in the exam (these will be
printed in consecutive film frames in the same
format).
In this case, you can choose to print
just the labelled images.

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- Set the required transmission options in the window that now opens and confirm with OK.

Note: The options are the same as those in the Spooler window that is enabled when you use the
DICOM archive or print commands (see point 4.5.2 above).

- Finally, start the printing procedure by sending the images to the print queue (Spooler).

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4.5.2.2 Show Spooler

The Show Spooler option lets you view and change the parameters in the Spooler function (see
figure below) that is responsible for managing the transmission of the images to the network. See the
technical manual for a full description of these parameters.

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4.5.3 TRANSFER OF IMAGES IN OVERVIEW MODE

Selected images in overview mode can be sent to the network.


Click on the image you want to select: a grey background highlights the selected images.
Hold Ctrl down to select more than one image at a time.

Selected image

Selected image

The selected images are transferred in exactly the same way as for a single image, i.e., by pressing
the right button on the mouse to open the dialog box that lets you select the Dicom Fast option (direct
access to the default storage device) or the Dicom option (selection of the storage device / opening of
the Dicom Spooler window).

Note: The transfer of images from overview mode involves store functions (Store selected) and
printing on film (Film editor), but not printing on a generic device (Print).

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4.6 WORK LIST

This function lets you manage a “work list” sent via the network using DICOM protocol.
The corresponding menu is activated from the Patients List by clicking on the relevant button.

Work List

The Hiris Worklist window appears with the following options:

- Get List to select the peripheral to be used to get and open the list.

- From and To to fix the start and end list dates.

- Create Exam to open the patient exam selected in the list.

- Toggle Check to enter changes to the list.

- Remove to remove an exam from the list.

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4.7 REMOVABLE “JAZ” ARCHIVE

The system lets you store the exams on a removable “JAZ” device (optional); you can create only one
archive with this device.

See the technical manual for details on how to install the device.

To create the archive, follow the same steps as for the creation of a fixed archive:

- Switch on the system and then:


- open the FILE menu from the MAIN FRAME,
- select the New Archive command.

New Archive

- The new archive menu appears. Open the Archives window.

- Use this window:


- to select Removable Disk,
- to assign the name of the archive (e.g.: archivio_HIRIS).

- Close the menu using the Save command (you will need to enter the Password MedService):
- the archive you have just created will open,
- close this with the Close command in the File menu.

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4.7.1 IMAGE ARCHIVING

To transfer images to the JAZ archive:

- From the MAIN FRAME open the archive holding the saved images that you want to save to the JAZ.
- Select the exam/patient you want.

- Open the Exam menu and select the Copy Exam(s) to command.

- Select the JAZ device (in the example above: archivio_HIRIS) and then confirm the command.

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4.7.2 OPENING AN ARCHIVE

From the MAIN FRAME open the archives:

- By clicking directly on the


“Open Archive” key:

- or by opening the FILE menu and


then selecting “Open Archive”.

In either case, the dialogue window “Archive List Manager” appears in the MAIN FRAME with a list
of all the available archives (in the example here, the JAZ archive is called “archivio_HIRIS”).

Click on Remove Click on Browse


to delete an archive from the list to search for an archive not included in the list

Select the JAZ archive and then confirm with OK (or double click on the archive or press Enter) to
open it and view the list of patients contained in the archive.

Note: To go from one archive to another, first close the current archive by selecting Close in the File
menu.

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4.8 REMOVABLE “CD” ARCHIVE

The system lets you store exams in DICOM format on CDs. The relevant device (CD Re-Writer) is an
optional.
See the technical manual for details of how to install the device and its software.

4.8.1 IMAGE ARCHIVING TO CD

- Switch on the system and insert a clean CD in the CD Re-writer.


- From the MAIN FRAME, open the archive where the images you want to save to CD are stored.
- Select the examination you want and open this.
- Right click to open the dialog box and select the Dicom / Create CD option.
The CD Image Configuration menu opens with all the DICOM format conversion options:

Uncompressed single-frame to store single images in their original format;


Jpeg 512x512 Multiframe to store all images in DICOM format, compressed
Jpeg, matrix 512x512.
Jpeg Up to 1kx1k Multiframe to store all images in DICOM format, compressed
Jpeg, matrix 1kx1k.
Insert only labelled images to store only the labelled images.
Insert Thumbnails in DICOMDIR to identify important images in the run.

- Click on OK to quit the menu, convert the images to the chosen format and open the CD-Image
Manager menu that lists all the exams already converted to DICOM format and thus available for
transfer to CD.

Edit README this shows the exam data,


Write CD this opens the CD-R Writer menu for copying to CD,

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Print Label this opens the menu for printing CD labels


(contact ATS to use this function).
Delete to remove an exam from the list.

- Select the exams you want to copy to CD using the CD-Image Manager menu.
Use the following keys to select more than one exam:
- Shift to select several exams in consecutive order in the list,
- Ctrl to select several exams not in consecutive order in the list.

- Use the Write CD command to open the copy to CD menu: this lists the exams you have just
selected:

- Use the Options command to open the CD Re-Writer


options menu and enable the options as required:

- Write Hidden Files to copy hidden files,


- Write System Files to copy system files,
- Beep N.U.
- Eject to eject the CD automatically at the end of CD rewriting,
- Joliet to select the relevant CD format,
- Cache MB recommended value = 4
- Speed recommended value = MAX.
- Add utility folder to add utility files to the CD
- Move to CD rootfolder to put all exams directly in the CD root.

- Close the options menu and then start the rewriting process by giving the Start Write command.

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4.8.2 IMPORTING IMAGES FROM CD ARCHIVE

- With the archive closed, select File / Import DICOMDIR.

Import DICOMDIR

- Select CD-Drive and open the archive using the menu that appears.

- Select the desired exam from the opened archive.

- Select the “Dicomdir” file for that exam and open it.

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4.9 PATIENT LIST MANAGEMENT

The following functions make it easier for you to manage the patient list in an archive:
- Re-order list
- Find exam
- Select exams.

4.9.1 RE-ORDER LIST

The patient list can be re-ordered in chronological order on the basis of either the exam date or the
patient's date of birth.
It can also be re-ordered alphabetically on the basis of the other fields:
- Patient name,
- Description,
- Body part,
- Laterality,
- View,
- ID (of patient),
- Sex,
- Physician.

To re-order the list, simply click on the top of the column containing the required parameter you want
to use. Click on this column again and the order is reversed.
If you then click on other columns, you get multiple re-ordering; the last command determines the
main re-order (the list shown in the figure below has been re-ordered by clicking first on Patient Name
and then on Physician):
Patient Name Physician
re-order command re-order command

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4.9.2 FIND EXAM

The Exam menu has 3 options that help you find an exam in the archive:

- Find
- Find Next
- Find Previous.

The Find command opens the Find Exam window


that lets you specify the initial string of the text you
want to find (Search Test) and the field to look in.
If an exam has already been selected, the search
starts from the next exam.

After using this command at least once, the other


two functions are enabled. These repeat the
search in the same manner: “forwards” (Find
Next) or “backwards” (Find Previous).

You can also do a quick search using the initial


letter of the Patient Name (without entering the
Find Exam menu):
- Press the letter on the keyboard and the system
displays the first exam in the list that satisfies the
search.
- Press the same key again to view the next exam
starting with that letter and so on.

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4.9.3 SELECT EXAMS

There are 3 commands in the Exam menu that let you select multiple exams in an archive (to use with
the Copy Exam(s) To command, for instance):

- Select All
- Select All Empty
- Reverse Selection.

Use Select All to select all the exams in the


archive.
Use Select All Empty to select all the empty
exams in the archive.
Use Reverse Selection to invert the chosen
selection mode (i.e. to go from empty exams to full
exams or from all exams to no exams).

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4.10 GENERAL SYSTEM CHECKS

To avoid the risk of exposing the patient to unwanted X-rays, we recommend carrying out the following
efficiency checks on a daily basis immediately after switching on the system and before treating the
patient.

To do this:

· Give the continuous fluoroscopy command using a TO DR phantom:

· Check the kV and mA parameters automatically set by the X-ray generator.


· Check the quality of the phantom image.

· Give the pulsed fluoroscopy command using a TO DR phantom:

· Check the kV and mA parameters automatically set by the X-ray generator.


· Check the quality of the phantom image.

· Give the one-shot fluorography command using a TO DR phantom:

· Check the time setting calculated by the system for the given kV and mA data.
· Check the quality of the phantom image.

· Give the fluorography and image subtraction commands using a TO DR phantom:

· Check that the system performs the correct sequence.


· Check the quality of the phantom image in subtraction mode.

· Give the image print-out command on the laser imager (if any):

· Check that the image is correctly printed on the film.

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Part 3: TECHNICAL DATA

LIST OF CONTENTS

page ed. date

CONTENTS I.1 0 15/07/03

1 EQUIPMENT CLASSIFICATION
1.1 Safety factor 1.1-1 0 15/07/03

2 TECHNICAL SPECIFICATIONS
2.1 System 2.1-1 to 2.1.2 0 15/07/03
2.2 PID image processor 2.2-1 0 15/07/03
2.3 Permissible exposure modes 2.3-1 0 15/07/03
2.4 Overall dimensions and cable lengths 2.4-1 0 15/07/03

3 FUSES
3.1 Fuses 3.1-1 0 15/07/03

4 IDENTIFICATION
4.1 Serial numbers 4.1-1 0 15/07/03
4.2 Component identification for traceability 4.2-1 to 4.2-2 0 15/07/03

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1 EQUIPMENT CLASSIFICATION

1.1 SAFETY FACTOR

- Protection against electrical shocks: . class I


- Safety factor against electrical shocks: . type B
- Safety factor against water penetration: . common device
- Degree of safety with inflammable gas: . device not suitable for use in the presence
of inflammable gases
- Conditions of use: . continuous service.

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2 TECHNICAL SPECIFICATIONS

The technical specifications for the system are as follows, split into four main groups:

1. System
2. PID digital processor
3. Exposure modes
4. Overall dimensions and cable lengths.

2.1 SYSTEM

Power supply single-phase voltage 230 V ± 10%, 50/60 Hz


standard plug 16 A
Electrical input max. value 720 VA
(without optional monitors)
Working environment temperature from 10 to 40°C
humidity from 20 to 80%
9” Image Intensifier model Thomson TH 9438 HX
nominal fields 12, 17, 23 cm
typical resolution at centre 68. 58, 52 lp/cm (for 4”, 6”, 9”)
contrast ratio (large area) 26:1, 21:1, 19:1 (for 4”, 6”, 9”)
DQE at 59.5 kV 65% (IEC standard)
2
conversion factor (9”) typ 180 Cd/m /mR/s
12” image intensifier model Thomson TH 9432 QX
nominal fields 17, 23, 32 cm
typical resolution at centre 68. 56, 50 lp/cm (for 6”, 9”, 12”)
contrast ratio (large area) 25:1, 20:1, 18:1 (for 6”, 9”, 12”)
DQE at 59.5 kV 65% (IEC standard)
2
conversion factor (12”) typ 370 Cd/m /mR/s
16” image intensifier model Thomson TH 9447 HX
nominal fields 17, 22, 32, 40 cm
typical resolution at centre 62, 54. 46, 42 lp/cm (for 6”, 9”, 12”, 16”)
contrast ratio (large area) 30:1, 20:1, 18:1, 15:1 (for 6”, 9”, 12”, 16”)
DQE at 59.5 kV 65% (IEC standard)
2
conversion factor (16”) typ 250 Cd/m /mR/s
Optical distributor shutter motorized iris
positioning time < 1 s
optical filter motor control
positioning time < 1 s
photosensor Hamamatsu
pause time < 100 ms (Rad mode)
TV Camera model TH 8730-121
sensor interline progressive scanning C.C.D.
active pixels: 1024X1024
saturation charge capacity: > 150000 electrons/pixel
active area: 13.1 x 13.1 mm
pixel correction yes
contrast resolution 12 bits (4096 grey levels)
dynamic range * 66 dB (max Signal / Noise in darkness)
sensitivity, at 30 dB (S/N)* 0.2 lux (P20 light)

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21” working monitor model GD 402


type 21” monochromatic, high resolution, high
contrast, high brightness
scanning horizontal: from 30 to 95 kHz
vertical: from 50 to 170 Hz
resolution 2 Mpixels
Additional 17” monitors model 17UHD
type 17” monochromatic, flicker free
scanning progressive
resolution 1280x1024 pixels
passband 120 MHz
Keyboard type Cherry:G84-4100 PAU
Main controller Microprocessor system Motorola MC 68332

* conditions: - fluoro mode


- integration time of 33ms

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2.2 PID IMAGE PROCESSOR

Video processor model PID


matrix Up to 1024x1024x12 bits
acquisition rate Up to 30 i/s for fluoroscopy
Up to 60 i/s for cine fluorography
dynamic storage 64 / 128 MB RAM
acquisition 12 bit converter
sampling frequency: 40 MHz
post-processing High speed spatial filters
H&V image reverse
90° image rotation
Cine-loop image display
Electronic shutters (square and
circular)
Reverse image polarity
Edge enhancement
Multi-image display
Zoom, variable (from 1.2 to 3)
Brightness and contrast control
Image subtraction
Pixel shift
Image sum
Land marking
graphics Grid
Distances
Angles
Stenosis
Overlay
Storage device HD
Capacity Standard. 18 GB
Up to: TBD
N° storable images Scopy: 1500 im/GB
Graphy: 750 im/GB
Cine: 6000 im/GB
N° images per run No limit: depends on disk capacity
N° exams No limit: depends on disk capacity
Transfer speed to HD Scopy: 30 im/s
Graphy: 15 im/s
Cine: 50 im/s
Computer operating system Windows NT 4.0
Interface for network: Ethernet TCP/IP Standard DICOM 3
for laser imager RS422
for removable medium SCSI
and for CD Re-Writer

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2.3 PERMISSIBLE EXPOSURE MODES

high resolution * low resolution *


Continuous digital fluoroscopy matrix 1024x1024x8 bits 1024x512x12 bits
rate 30 i/s
Continuous digital fluoroscopy matrix 1024x512x12 bits 512x512x12 bits
low dose rate 30 i/s
Pulsed digital fluoroscopy matrix 1024x1024x8 bits 1024x512x12 bits
rate 0.5, 1, 2, 3, 6, 10, 15, 30 i/s
Pulsed digital fluoroscopy matrix 1024x512x12 bits 512x512x12 bits
low dose rate 0.5, 1, 2, 3, 6, 10, 15, 30 i/s
Digital Cine-Fluoroscopy matrix 1024x1024x8 bits 512x512x8 bits
(optional) rate 15, 30 i/s 15, 30, 60 i/s
Digital fluorography matrix 1024x1024x12 bits 512x512x12 bits
rate single, 0.5, 1, 2, 3, 6, 10, 15 i/s single, 0.5, 1, 2, 3, 6, 10, 15, 30 i/s

* : In the fluoroscopy modes, the “high resolution” option (recommended) is selected during the
installation of the system; see the technical manual for details (part 4, point 2.2: “General
settings”).
In the cine and fluorography modes, however, you can select this option during exposure by
choosing the relevant acquisition matrix on the command console (see part 1, points 1.3 and 1.4
of this manual).

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2.4 OVERALL DIMENSIONS AND CABLE LENGTHS

Cabinet dimensions 650 x 520, h 880


9” I.I. unit, optical distributor and TV camera dimensions 380 x 570 x 410 (b x h x l)
12” I.I. unit, optical distributor and TV camera dimensions 380 x 570 x 410 (b x h x l)
16” I.I. unit, optical distributor and TV camera dimensions 470 x 650 x 480 (b x h x l)
Alphanumerical keyboard dimensions 282 x 132, h 26
21” working monitor dimensions 498 x 485 x 538 (b x h x l)
Monitor stand dimensions 540 x 1015 x 600 (b x h x l)
17” monitor dimensions 415 x 335 x 345 (b x h x l)
Cabinet / I.I. unit cables standard 15 m
optional 25 m
Cabinet / working monitor cable standard 15 m
Cabinet / keyboard and console cable standard 15 m
Cabinet / 17” monitor cable standard 15 m
optional 25 m

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3 FUSES

3.1 FUSES

The system is protected by a series of fuses, as below:


- 2 fuses on the 230 V power supply line,
- 7 fuses on the inputs/outputs of the Main Controller M.CON board transformer,
- 2 fuses on the input/output of the ASPS power supply board transformer,
- 1 fuse on the RGBC power supply board,
- 1 fuse on the console board.

The table below contains the main data for these fuses.
The general layout codes and board codes are used as references; see the technical manual for
further information.

name type circuit protected position reference


(for fuses)
F1, F2 2 x 4 AT General protection Main power supply inlet 72 00 100
F1, F2 2 x 315 mAT Main Controller (transformer) Main Controller power input 72 00 000
F1 500 mAT +5V power supply Transf. TR1 output, board M.CON 72 00 000
F2 500 mAT +15V power supply Transf. TR1 output, board M.CON 72 00 000
F3 500 mAT -15V power supply Transf. TR1 output, board M.CON 72 00 000
F4 1.6 AT +24V2 power supply Transf. TR1 output, board M.CON 72 00 000
F5 1 AT +VCOIL FILTER power supply Transf. TR1 output, board M.CON 72 00 000
+5V SENSOR power supply
F1 315 mAT Board ASPS Transf. TR1 input, board ASPS 17 10 110
F2 1 AT Board ASPS Transf. TR1 output, board ASPS 17 10 110
F1 500 mAT Board RGBC power supply Board RGBC 70 01 060
F1 315 mAT Primary coil transformer TR1 21 Vca board 70 01 070
F2 500 mAT Secondary coil transformer TR1 21 Vca board 70 01 070

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4 IDENTIFICATION

4.1 SERIAL NUMBERS

The system is identified by a rating/serial number plate at the back of the cabinet. A copy of this plate
is also found inside the cabinet, on the power supply box.

The serial number is also marked on the Main Controller module.

- at the back
- inside, on the power supply box

MAIN CONTROLLER for


OPERA D4000 03 001 75 03

Inside,
on Main Controller module

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4.2 COMPONENT IDENTIFICATION FOR TRACEABILITY

The system components are identified with their own serial numbers as follows:

Component Serial no. Position Figure

I.I. tube Supplier’s Visible, on tube Fig. 1


Optical distributor Supplier’s Accessed by removing the cover Fig. 1
CCD TV camera Supplier’s Accessed by removing the cover Fig. 1
PID image processor Supplier’s Front and back, Fig. 2
accessed by opening the cabinet
21” working monitor Supplier’s On rear protection cover Fig. 3
17” monitor, optional ATS On rear protection cover Fig. 4
Monitor stand, optional ATS On side of plate Fig. 5
(for 17” monitor)

The figures below show the position of the component serial number plates.

Optical distributor serial no.


(acessed by removing the cover)

CCD TV camera serial no.


(accessed by removing the cover)

I.I. Tube serial no.

Fig. 1

HIRIS 012

PID serial no : - at the front


- at the back

Fig. 2: PID

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Working monitor serial no.


(on rear cover)

Fig. 3

ATS
MONITOR 17UHD on rear cover
SERIAL 01 001 71 00 and on the inside
SUPPLY 230V~ 50/60Hz 160VA
MADE IN ITALY

Fig. 4

ATS
MONITOR TROLLEY
SERIAL 02 054 40 00
MADE IN ITALY

Fig. 5

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