diva-d (user's manual)

8/15/2019 DIVA-D (User's Manual)

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Release 4 January 2006 (Rev. 0)

DIVA-DDIVA-DDIVA-DDIVA-D 0123012301230123Digital Imaging Video Acquisition

with full DICOM compatibility

User’s manualUser’s manualUser’s manualUser’s manual


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USER’S MANUAL Contents

(Rev. 0) DIVA-Di

Contents1 INTRODUCTION 1

1.1 Icon appearing in the manual................................................................. 1

2 SAFETY ASPECT 2

2.1 Warning.................................................................................................. 3

2.2 Environmental risks and displacement................................................... 5

2.3 Symbols used ......................................................................................... 6

3 DESCRIPTION 73.1 Identification labels ................................................................................ 7

3.2 Description ............................................................................................. 8

3.2.1 DIVA-D composition ................................................................... 9

3.2.2 Monitors..................................................................................... 9

3.2.3 Accessories................................................................................. 9

4 TECHNICAL DATA 10

4.1 DIVA-D AS 25....................................................................................... 10

4.2 CRT Monitor ......................................................................................... 15

4.3 LCD Monitor ......................................................................................... 17

4.4 Environmental conditions..................................................................... 18

4.5 Standards............................................................................................. 18

5 KEYBOARD AND FUNCTIONS 19

5.1 Functions description ........................................................................... 20

6 UNIT SWITCHING ON 22

6.1 CCD camera not connected .................................................................. 24

6.2 System fault ......................................................................................... 25

7 PATIENT DATA 26

8 FLUOROSCOPY 28

8.1 Fluoro special function ......................................................................... 30

9 MODALITY SELECTION 31

10 GRAPHY 33


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USER’S MANUAL Contents

DIVA-D (Rev. 0)ii

11 POST PROCESSING 35

11.1 Special function.................................................................................... 39

11.2 Multi image........................................................................................... 41

11.3 Image print ........................................................................................... 42

12 DICOM FUNCTIONS 43

12.1 Waiting list ........................................................................................... 44

12.2 Queue view and flush ........................................................................... 45

12.3 Print ..................................................................................................... 47

12.4 Store..................................................................................................... 49

12.5 CD - ROM ............................................................................................. 51

13 MAINTENANCE AND CLEANING 54

13.1 Frequency of maintenance and cleaning actions ................................... 54

This publication can only be reproduced, transmitted, transcribed, or translatedinto any human or computer language with the written consent of VILLA SISTEMIMEDICALI S.p.a.

This manual in English is the original version.


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USER’S MANUAL Introduction

(Rev. 0) DIVA-D1

1111

INTRODUCTIONINTRODUCTIONINTRODUCTIONINTRODUCTION

NOTE: The present manual is updated for the product it is sold with in order togrant an adequate reference to use properly and safely the product.

The manual may not reflect changes to the product not impactingoperating modes or safety.

DIVA-D is an acquisition, storing and processing digital system studiedto process digitalized images.

The purpose of this manual is to give the User instructions for a safe andefficient use of the DIVA-D.

The device must be used in compliance with the procedures described inthe user manual and never used for purposes different than the onesdescribed in the user manual.

Qualified personnel only, having necessary knowledge on X-ray protection can use the device.

1.11.11.11.1 Icon appearing in the manualIcon appearing in the manualIcon appearing in the manualIcon appearing in the manual

This icon indicates a NOTE: please read thoroughly the items marked by this picture.

This icon indicates a WARNING message; the items marked by this iconrefer to the safety aspects of the patient and/or of the operator.


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USER’S MANUAL Safety aspect

DIVA-D (Rev. 0)2

2222

SAFETY ASPECTSAFETY ASPECTSAFETY ASPECTSAFETY ASPECT

WARNING: Please read this chapter thoroughly.

VILLA SISTEMI MEDICALI devices comply with the related safety requirements; furthermore it supplies all information necessary for a correct use and the warnings related to danger associated with X-raysgenerating units.

VILLA SISTEMI MEDICALI, has not to be held responsible for:

• use of DIVA-D different from the intended one as described in thismanual;

• damages to the unit, to the operator, to the patient, caused either by wrong installation or maintenance procedures, different from thosedescribed in the Servcie manual and in the user manual supplied

with the unit, and by wrong operations;

• mechanical and/or electrical modifications performed during and

after the installation, different from those described in the officialdocumentation of the product.

Any technical intervention must only be performed by VILLA SISTEMI MEDICALI qualified technicians.

Only the authorized personnel can remove the covers and/or haveaccess to the components under voltage.


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(Rev. 0) DIVA-D3

2.12.12.12.1 WarningWarningWarningWarning

This device has not been designed to be used in environments where vapors, anaestethic mixes flammable with air, or oxygen and nitrousoxide can be detected.

Avoid pouring water, even accidentally, or other liquids into the device,as this could cause short-circuits.

Before cleaning the device, please disconnect it from the line voltage.

Wherever necessary, use the fit accessories, such as the leaded aprons,to protect the patient from radiation exposure.

While performing the radiography, no one, apart from the operator andthe patient, must remain in the room.

Though this unit has been designed with a quite acceptable protectionlevel from electromagnetic interference, it is advisable to install it at a certain distance from electrical energy transformation rooms, from staticcontinuity units, from portable receiving-transmitting units for amateurial use and for cellular use. Cellular telephones are only admitted at a distance of more than 1.5 m from any component of thedevice.Other medical instruments and devices that must be used in the sameinstallation area of the unit must comply with the ElectromagneticCompatibility rules in force. Non-complying instruments, of which thepoor immunity from electromagnetic fields is well known, must beinstalled at least 3 m away from the DIVA-D and supplied by a different electrical line.

DIVA-D cannot be installed in operating theatres.DIVA-D must be off while using devices such as electrical scapels or similar instruments.

The equipment automatically performs some self-test functions andtherefore is able to detect some anomalous conditions. However,

whenever there are doubts on the performance of the equipment (e.g.images too clear, too dark or with artifacts), the activity must be

suspended and a Villa Sistemi Medicali qualified and authorized engineer must be contacted.

WARNING:If during the self-test phase the equipment shows a failure messagecaused by the electronic circuits or the Ram disks, the images of a givenpatient retrieved for post processing may not belong to the requestedpatient.In this case, immediately contact an authorized Villa Sistemi Medicaliengineer and do not make any diagnosis or evaluation on the storedimages.

In addition, as the failure may have occurred during the last workingsession, diagnosis carried out after the last exam cannot beconsidered valid.


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DIVA-D (Rev. 0)4

During the use of the equipment, the operator must comply with the

local work safety regulation, in particular with the ones referring to theuse of video terminals.

The cathode X-ray tube (CRT) of the monitors, when present, ismanufactured in order to minimize the risk of implosion. However, if heavily hit it may break thus projecting out pieces of glass, powder andtoxic gas. Avoid hitting the CRT with any object and make sure that it does not hit any object.

These risks are not present when LCD monitors are used.


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(Rev. 0) DIVA-D5

2.22.22.22.2 Environmental risks and displacementEnvironmental risks and displacementEnvironmental risks and displacementEnvironmental risks and displacement

The DIVA-D contains in some of its parts, materials that at the end of theunits life, must be recycled at an approved location.Particularly the device contains the following materials and/or components:

• Central unit and control console: iron, copper, aluminum, non- biodegradable plastic material, glass-resin for printed circuit board(PCB)

• CRT Monitor, TV camera: glass vacuum tubes, iron, copper,

aluminum, glass-resin for printed board, non-biodegradable plasticmaterial.

WARNINGGlass vacuum tube may implode with projection of glass pieces, powder and toxic gas.


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DIVA-D (Rev. 0)6

2.32.32.32.3 Symbols usedSymbols usedSymbols usedSymbols used

Symbol Description

Warning, read the relevant documentation

The equipment contains in some of its parts,materials that at the end of the units life, must berecycled at an approved location

∼ A.C.

0123Complies with Medical Equipment Directive 93/42

Device with type B applied parts

Dangerous voltage


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USER’S MANUAL Description

(Rev. 0) DIVA-D7

3333

DESCRIPTIONDESCRIPTIONDESCRIPTIONDESCRIPTION

3.13.13.13.1 Identification labelsIdentification labelsIdentification labelsIdentification labels

1

Main label (rack)

2

Control keyboard label

3

CRT Monitor label

4

LCD Monitor label

1

2

4

3


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DIVA-D (Rev. 0)8

3.23.23.23.2 DescriptionDescriptionDescriptionDescription

DIVA-D is a digital acquisition, storing and processing system for radiological images. The large storing capacity allows performing thefollowing functions:

• Image acquisition and storing in FLUOROSCOPY

• Image acquisition and storing in EXPOSURE with the following working programs: SPOT, BONE, ANGIO, PERIF, STEP, TOMO

• Post-processing of the acquired images, thanks to a dedicatedprogram

• Printing of the acquired images through a laser printer.

• Sending via Dicom network acquired images to Pacs system.

The images coming from the image intensifier are acquired through a CCD camera, then fed to the digitalization stage (A to D Converter) after that they can be stored in the permanent memory (Ram disk).From this moment on the images can be processed thanks to thededicated software programs.

The system has a large accessible database, which allows for the entry and retrieval of patient information along with exam description, remark and notes.

DIVA-D is available in 2 versions:

DIVA-D RF 12

Ram Disk capacity 36 Gbytes

Operator monitor 1 or 2 on request

"In room" monitor 0, 1 or 2 on request

Imaging acquisition (max speed andmatrix)

12 imag/sec matrix 1024x1024


Functions • standard acquisition: YES

• imaging subtraction: NO• road mapping: NO

• fluoro store: YES

DIVA-D AS 25

Ram Disk capacity 72 Gbytes

Operator monitor 1 or 2 on request

"In room" monitor 0, 1 or 2 on request

Imaging acquisition (max speed andmatrix)



Functions • standard acquisition: YES

• imaging subtraction: YES

• road mapping: YES

• fluoro store: YES


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(Rev. 0) DIVA-D9

3.2.13.2.13.2.13.2.1 DIVA-D compositionDIVA-D compositionDIVA-D compositionDIVA-D composition

DIVA-D contains the following components:

• Rack containing all electronics (computer, PCB's, Ram disk, power supply, etc).

• Control keyboard.

• CCD TV camera.

• POD (Printed Ouput/input Device) pcb interface for table andgenerator.

• Laser interface for standard digital protocol (P831) when Dicommodule is not present only.

3.2.23.2.23.2.23.2.2 MonitorsMonitorsMonitorsMonitors

All DIVA-D models are available with CRT or LCD monitors for operatorsand "in room".

The size of these monitors depends on customer request.

3.2.33.2.33.2.33.2.3 AccessoriesAccessoriesAccessoriesAccessories

Depending on the request, DIVA-D can be supplied with accessories:

• DICOM module equipped with SW package for:

− print

− store

− worklist

− CD write

• Remote control function.

• Ceiling suspension for "in room" monitor.


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USER’S MANUAL Technical data

DIVA-D (Rev. 0)10

4444

TECHNICAL DATATECHNICAL DATATECHNICAL DATATECHNICAL DATA

NOTE: Technical data, performance and instructions provided in this manualare referred to the DIVA-D AS 25 model. Therefore, some of thesecharacteristics are not applicable for DIVA-D RF 12 systems.

4.14.14.14.1 DIVA-D AS 25DIVA-D AS 25DIVA-D AS 25DIVA-D AS 25

Identification

Type DIVA-D AS 25

Model NDR 632 E00 + NDR transf 02

Components

Central unit Rack composed by:Power supply; Computer; Pcb's; Ramdisk

Control system Flat control keyboard

Acquisition by CCD Camera 1024 x 1024

Interface system Generator and Remote Control Tableinterface PCB

Connection cables Prepared interconnection cables

Monitor Operator: 1 or 2 on request "In room": 1 or 2 on request

Dimension and weight Central Unit (Rack)

Weight 15 Kg

Height 254 mmDepth 345 mm

Width 440 mm

Dimension and weight Control keyboard

Weight 6 Kg

Height 50 mm

Depth 235 mm

Width 460 mm


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DIVA-D (Rev. 0)12

DICOM module (optional) Technical characteristics

Processor management Intel ™

Working frequency 1 GHz

Ram memory 512 Mbytes

Transit memory Ram disk 40 Gbytes

Dicom images backing Ram disk 40 Gbytes

Network access speed 100 Mbit

SW package available -Print (1024x1024 16bit)-Store (1024x1024 16bit @ 3 Mbyte)-CD write (1024x1024 8bit)

(512x512 8 bit)-Worklist

Imaging acquisition (speed and matrix)

Mode 12 bits progressive scanning acquisitionand visualization

Fluoroscopy Matrix 1024x1024 Acquisition max rate25 fr/sec

Pulsed fluoroscopy Matrix 1024x1024 Acquisition selectable rate:

1-3-6-12-25 fr/sec

Exposure and angiography Matrix 1024x1024 Acquisition max rate25 fr/sec

Imaging memorization

Storage Automatic and permanent.

Maximum access time to disk for image write and read (with matrix 1024x102416 bit)

30 msec.

Memory capacity 72 Gigabytes

Maximum storage capacity of images

with matrix 1024x1024

36000 images

Electrical characteristics

Standard power supply (transf 02) 230 V ac ±15%

Standard power supply (DIVA-D rack) 24 V ac ±15%

Frequency 50-60 Hz

Current absorbed 650 mA @ 230 V ac

Power absorbed 150 W @ 230 V ac


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(Rev. 0) DIVA-D13

Working configuration

Remote R\ F control table - Apollo- Mercury 332

R\ F tilting table - Vision

Integration with generator Genius 65/80 HF-A with serial mode(RS 232) interface

Clinical application

Fluoroscopy Continuous and pulsed HCF

Standard exams and with contrast agent Gastroenterological, bone exams, ERCP,Urology, Mielography, etc.

Tomography In low dose modality

Vascular exams Thoracic angiography, carotid,peripheral, phlebography.Exams with on-line subtraction andpost processing.

Peripheral steps Angiography Optional. Possible application with Apollo remote control table only.

Working characteristics

User interface Windows representation

Fluoroscopy mode

Storage Manual start on Ram disk

Regulation of the parameter Auto video level regulation. Auto radiological parameter regulation.Manual selection of six field video levels

Edge enhancement Two selectable levels

Positive/Negative function (grey scaleinversion)

In line/off line

Noise reducer Two selectable level

Road mapping Direct maskingImaging comparison Automatic or manual transfer of the

image

Last image hold (LIH) With integrated image

Manual regulation of the video level Three selectable levels

Motion detection filter Automatic exclusion of the recursivefilter during the movement of the image(no blurring effect)

Dynamic recursive filter DRF Automatic noise/blurring optimizationeffect offers zero persistence


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(Rev. 0) DIVA-D15

4.24.24.24.2 CRT Monitor CRT Monitor CRT Monitor CRT Monitor

NOTE: The characteristics of the monitors are the same for both DIVA-D'smodel.

Technical data

Type Monitor CRT B&W

Manufacturer Nical

Model Refer to optional

Dimensions and weight Monitor 17” Monitor 21”

Weight 17,5 Kg 21,8 Kg

Height 335 (359) mm 394 (418) mm

Depth 350 mm 380 mm

Width 405 mm 489 mm

Screen dimensions 17" (414 mm) 21" (511 mm)

Electrical characteristicsStandard power supply 230 V ac ±15%

Frequency 50-60 Hz

Current absorbed 350 mA

Power absorbed 80 W

Scanning

Type Interlaced

Line number 1049

"Refresh" frequency 60 Hz

Standards EIA

Video input signal

Type Video input connected ac

Connection type BNC

Impedance 75 Ω

Input video signal 0,5 to 1,5 V pp (negativesynchronism)


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DIVA-D (Rev. 0)16

Display characteristics

Deflection angle 90°

Aspect ratio 4:3

Band width 40 MHz ±3 dB

Raster 0.25 mm

Phosphor White P45

Geometric error


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(Rev. 0) DIVA-D17

4.34.34.34.3 LCD Monitor LCD Monitor LCD Monitor LCD Monitor

NOTE: The characteristics of the monitors are the same for both DIVA-D'smodel.

Technical data

Type Monitor LCD B&W

Manufacturer Nical

Model Refer to optionals

Dimensions and weight Monitor 18” Monitor 20”

Weight 5,5 Kg 6,0 Kg

Height 340 mm 355 mm

Depth 60 mm 60 mm

Width 430 mm 457 mm

Screen dimensions 18" 20"

Electrical characteristicsStandard power supply 230 V ac ±15%

Frequency 50-60 Hz

Current absorbed 250 mA

Power absorbed 50 W

Display characteristic

Visibility angle 180°

Contrast 600:1

Resolution 1280x1024

Gray scale 768 levels

Max luminance 700 Cd/m2

Calibration automatic

Optional

Contrast and brightness control with digitalpush-button on front panel and rear remotecontrol connection

Available on request on all models

Contrast and brightness control only withrear remote control connection

Available on request on all models


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DIVA-D (Rev. 0)18

4.44.44.44.4 Environmental conditionsEnvironmental conditionsEnvironmental conditionsEnvironmental conditions

Operative Temperature: from -10° to +45° CelsiusHumidity: up to 95 % not condensing

Transport and storage Temperature: from -35° to +65° CelsiusHumidity: up to 95 % not condensing

4.54.54.54.5 StandardsStandardsStandardsStandards

DIVA-D system with accessories and optional complying with the relevant standards:

EN 60601-1Electro medical equipment. General safety requirement (included amendment A1+A2+A11+A12+A13)

EN 60601-1-2

Electro medical equipment. General safety requirement.2 – Collateral standards: Electromagneticcompatibility.

EN 60950 Information device safety

0123 The symbol CE grants that DIVA-D complies withEuropean directive 93/42

Further information regarding standards complying can be requested to:

VILLA SISTEMI MEDICALI S.p.A. Via delle Azalee, 320090 - Buccinasco - (MI) - Italia

Tel: +39-02-48.859.1Fax: +39-02-48.818.44

The manufacturer of the equipment DIVA-D is (according to the93/42/CEE European directive):

NICAL S.p.A. Via Soffredini, 4320126 - Milano - Italia

Tel.: +39-02-25.711.10Fax: +39-02-25.722.07


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USER’S MANUAL Keyboard and functions

(Rev. 0) DIVA-D19

5555

KEYBOARD AND FUNCTIONSKEYBOARD AND FUNCTIONSKEYBOARD AND FUNCTIONSKEYBOARD AND FUNCTIONS All functions of DIVA-D are activated through buttons located on a dedicated keyboard.

The following picture and relevant buttons functions descriptions permitsto locate easily all reference of the present manual.


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DIVA-D (Rev. 0)20

5.15.15.15.1 Functions descriptionFunctions descriptionFunctions descriptionFunctions description

To adjust the kV value when automatic mode isactive.It is possible to increase and decrease the imagelevel with XX steps.

R.O.I. selection. 6 different areas can be selected for the auto kV correction in function of dimension andposition of the image area to be optimized.

To store fluoroscopy images.

To enable the road mapping function. It is used assupport during catheter insertion.

To select the fluoro modality between continuousand pulsed.

To select the frame rate exposure acquisition.

When a new patient must be recorded the key permits to access the patient data window.Mode is used to enter into modality and anatomicexam selection.

To enter into patient data base to perform post processing mode.

In post processing mode, when a patient is recalledfrom data base, to select run into the patient andthe frame into run.

To play a run that contains more then one frameand to stop the sequence visualization.


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(Rev. 0) DIVA-D21

These keys allows to enter into different post

processing mode:− symmetric and asymmetric image limitation

− negative-positive

− zoom x4 with scroll

− cine loop review

− multi image runs selection.

These keys allows to enter into different post processing angiographic mode:

− mask shift with 1/8 pixel step

− mask present or removed

− manual mask selection

− remasking.

To modify images quality in post processing:

− manual windowing

− edge enhancement

− auto windowing

− reset of the modifications.

To access into fluoroscopy or post processingspecial function.

To enter into DICOM (optional) modality, to savedata into DICOM module and to print or store thecaptured images.

This group of keys are used as auxiliary functionsduring the different modality.

Alphanumeric keys used to write characters indifferent working modalities.

This manual is divided in different chapters, each of one is dedicated to a working modality which DIVA-D supports.In any chapter it is explained how to use the buttons located on thekeyboard to optimize the DIVA-D use.


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USER’S MANUAL Unit switching ON

DIVA-D (Rev. 0)22

6666

UNIT SWITCHING ONUNIT SWITCHING ONUNIT SWITCHING ONUNIT SWITCHING ON Any time that DIVA-D is switched on, it performs an auto test to verify if the CCD camera is connected and correctly working and if the electronicsof the main rack, including RAM disks are normally operating.

At start up, self test starts and the window is displayed:

where software and hardware information is displayed.In the first area the software versions present in the unit are indicated.

This information allows the user and service engineer to identify the unit configuration.In the second area the hardware characteristics and the “license level”are displayed. This field permits to identify which functions are availableon the DIVA-D.

At the end of start up, three conditions are possible:

- No error code The Unit automatically goes to full operation and the display shows.

SYSTEM READY

Device is ready to operate.


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(Rev. 0) DIVA-D23

If a DIVA-D is equipped with DICOM module after about 2 minutes

from this condition, the monitors shows:

SYSTEM READY

DICOM READY

This delay is determined by the DICOM module initialization timethat is longer than the DIVA-D one.

- Camera not connected (see paragraph 6.1)

It is necessary to press ENTER key to escape from this condition.Unit goes to off line operation only.

- System fault (see paragraph 6.2)

Unit stops. A service engineer is required.


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DIVA-D (Rev. 0)24

6.16.16.16.1 CCD camera not connectedCCD camera not connectedCCD camera not connectedCCD camera not connected

During auto test, the unit could recognize a fault in the CCD camera connection.In this condition the window shows:

It is necessary to press ENTER key to escape from this message.In this condition the device goes into post processing mode in which it

will be possible to perform review only of exams already stored.No acquisition of new images is possible.


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(Rev. 0) DIVA-D25

6.26.26.26.2 System faultSystem faultSystem faultSystem fault

If auto test recognizes an analogic, digital or disks fault the window shows:

The unit is out of work and a service engineer must be contacted.


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USER’S MANUAL Patient data

DIVA-D (Rev. 0)26

7777

PATIENT DATAPATIENT DATAPATIENT DATAPATIENT DATABefore starting with a new exam is necessary to insert into DIVA-D thedata of the new patient.If this is not done, as soon the exposure images acquisition is required,the message:

is displayed.It is necessary to press NEW PATNT key to open the patient data entering window.

NOTE:If fluoroscopy mode is activated, without storing any LIH or any fluorosequence, the images visualization is present also if no patient data isinserted. This because a patient could perform a fluoroscopicinvestigation only. In all other cases, because all radiographic images are

automatically stored on RAM disks, the patient data must be entered intothe data base.

When the key NEW PATNT is activated the new patient window isdisplayed:


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USER’S MANUAL Patient data

(Rev. 0) DIVA-D27

If DICOM module is present the “worklist” selection is allowed, otherwise

no.For this function, please refer to DICOM functions chapter.

By using UP or DOWN arrow keys activate the selection required between"DATA ENTRY" or "LAST PATIENT".Press ENTER key to confirm.

If “data entry” is selected, the window appears:

By using UP or DOWN arrow keys select the required fields. The surname field is mandatory, the others are optional.

NOTE:If the birth date is not entered, the patient age in the data base will berecorded as 0.

If sex is not inserted, O (other) will be present in the data base).

Confirming by ENTER, the data are stored into the data base and themodality window is displayed to permit the acquisition mode selection.

If "last patient" is selected, the PATIENT DATA window appears with thedata relevant to the last patient stored.

This selection is used when during exam on a patient, the unit has beenswitched off.

This feature is very useful to avoid 2 files for the same patient.


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USER’S MANUAL Fluoroscopy

DIVA-D (Rev. 0)28

8888

FLUOROSCOPYFLUOROSCOPYFLUOROSCOPYFLUOROSCOPYIf DIVA-D is equipped with 2 monitors in the control desk area, one of them is reserved to fluoroscopy images only, otherwise the fluoro window is present any time the fluoro command is activated.

The following functions and information are available in this modality:

• Status

The visualization could be X-ray during acquisition or L.I.H. (Last Image Hold) in off line.

• Reg. of int

The visualization is modified according to selection.ROI (Region Of Interest) must be modified in function of position anddimension of the organ. 6 different ROI are available troughcorrespondent keys. Maintaining pressed the key relevant to the ROIselected for 3 sec, the ROI dimension and position is displayed on theimage.

• Modality

This field could be STD or PULSE xx fr/sec.

By means of the key the fluoro mode can be selected. When led is off, STD is displayed in the window, meaning that thefluoro mode selected is continuous.

When led is on PULSE with the frame rate is displayed in the window. This rate can be modified using keys FR/s + and FR/s -.


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(Rev. 0) DIVA-D29

• Store

In normal use the condition is OFF. To activate the fluoro storingmodality it is necessary to press STORE. The relevant led turns onand the images number stored are indicated at the bottom of thedisplay.

When fluoro acquisition is interrupted also the storage is stopped. At new fluoro acquisition it will be necessary to press the STORE key again to perform a new storage.In LIH condition, pressing the STORE key, the LIH will be stored intothe hard disk.

• Edge

By default the value is OFF. It means the edge level used is the

default one. Using E key, the visualization is ON and the edge levelselected is the one configured at the installation.

• Noise

By default the value is OFF. It means the noise suppression levelused is the default one. Using N key, the visualization is ON and thenoise level selected is the one configured at the installation.

• Road map

Road mapping function is available on DIVA-D AS25 only. The function is activated by using the ROAD MAP key. Pressing thekey, the relevant led turns on and the fluoro images will be in

subtractions mode.Releasing fluoro, on the display the LIH will be in sub mode andfollowing fluoro images will have the mask overlapped.

To reset the road mapping mode and the mask, press the key withfluoro off.

The Led will be turned off and next fluoro will be performed instandard mode.

• Kv – mA – Dose

In these fields the actual kV and mA are displayed.Dose field is not yet activated.

• Run – FrameIn these fields the fluoro run number stored for the present patient and the images contained in the run are displayed.

The dose level can be modified by using the keys kV+ and kV-. The effect of this action is the image contrast level becoming higher or lower depending by the key activated. 3 decreasing steps and 3increasing steps are available starting from the standard level.

The radiological parameters are automatically adjusted by the system,during fluoro acquisition to optimize the image video level.

This adjustment is calculated based on ROI selection.


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DIVA-D (Rev. 0)30

8.18.18.18.1 Fluoro special functionFluoro special functionFluoro special functionFluoro special function

In fluoro off line mode, by pressing the SPEC FUNCT key, the relevant window is displayed:

By using UP or DOWN arrow keys select the field required.Press RESET key to activate the relevant selection.

• Store XX Fr/s

The storage rate in fluoro can be selected to preserve disk space. This selection modifies the storage speed only without modifying the visualization rate.

• Standard / Pulsed

This selection can also be done in on line mode by using the pulsedkey as described above.

• Ref image This selection appears when DIVA-D is equipped with 2 monitors incontrol desk area only.

When this selection is active the graphy monitor is used to display the LIH while on fluoro monitor the live images are displayed.

• Pattern 1 / 2

Allows to display 2 different patterns in order to adjust correctly themonitor brightness and contrast.


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USER’S MANUAL Modality selection

(Rev. 0) DIVA-D31

9999

MODALITY SELECTIONMODALITY SELECTIONMODALITY SELECTIONMODALITY SELECTION When patient data are inserted, the modality and relevant anatomicprograms must be chosen.

The access to this function is automatic when exiting from patient data window with ENTER key or any time the MODE key is activated. This because when a new patient is inserted it is necessary to select themodality for the first acquisition, and to change this modality if a patient requires different exams type.

The acquisition modality can be:

• SPOT

• BONE• ANGIO

• PERIF

• STEP

• TOMO.

SPOT, BONE and TOMO are allowed for both DIVA-D models RF and AS, ANGIO and PERIF on AS only, STEP could be present on a AS model only as supplementary option.

The step modality is allowed only if the system is based on APOLLO tableonly.

The modality window looks as follows:

It is divided in 3 areas:

• modality selection

• anatomic selection

• parameters modification.By default the left area is active when modality is selected. To informabout the area selected, the background is light gray.


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USER’S MANUAL Modality selection

DIVA-D (Rev. 0)32

By using UP and DOWN arrow keys, select the required modality, by

using RIGHT arrow key select the anatomic area, this background becomes light grey and select now the desired anatomic program.

NOTE: The not available modality (depending by the DIVA-D license level) will bedisplayed in gray and not reachable by selection.

On the right area the parameters associated to the selected anatomicprogram are displayed.

To modify permanently one or more parameters, press RIGHT arrow key,

the background will be light gray (as in picture) and by using relevant keys, the associated parameter can be changed.Using alphanumeric keys the anatomic name will be modified and themessage “ENTER to save” will appear on window bottom side.By ENTER key the new anatomic configuration will be stored.

If a temporary modification, on an existing anatomic program, need to bedone it will be sufficient to modify the relevant parameter by using theassociated key.Confirming by ENTER key, the acquisition mode will be selected with themodified parameters.

In modality function, the parameters associated will be different assummarized below:

SPOT BONE ANGIO PERIF STEP TOMO

ROI ROI ROI ROI ROI ROI

Frame rate Edge Frame rate Frame rate Frame rate Tomo frames

Edge Low dose Edge Edge Edge Edge

Low dose Neg – Pos Low dose Low dose Low dose Low dose

Neg -Pos Neg – Pos Neg – Pos Neg – Pos Neg – Pos

Auto mask Auto mask Auto mask Pulsed fluoro

Sub cont Sub cont Sub cont

Kv reduction


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USER’S MANUAL Graphy

(Rev. 0) DIVA-D33

10101010

GRAPHYGRAPHYGRAPHYGRAPHY When the modality selection is done and confirmed, DIVA-D is ready for graphy acquisition.

The window displayed is:

on which the patient data, modality and anatomic parameters aredisplayed.Now the acquisition can start or anatomic parameters modification can

be done by using the associated keys.If a key for modification is pressed (i.e. ROI, Frame/sec ecc) the modality

window will be displayed.

Before to start with graphy acquisition, a fluoro acquisition must bedone.

This action allows DIVA-D to calculate the correct exposure parameters

(technique factors). As matter of fact at the exposure request, DIVA-D informs the generator about the technique factors to be used for the graphy acquisition.

The area “Run” is reserved to the number of exams stored for the present patient.During acquisition the areas “Run”, “Frame”, “mSec” and “kV” areupdated.


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DIVA-D (Rev. 0)34

At the end of acquisition the following window will be displayed:


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USER’S MANUAL Post processing

(Rev. 0) DIVA-D35

11111111

POST PROCESSINGPOST PROCESSINGPOST PROCESSINGPOST PROCESSING To review the exams contained for the current “patient”, 2 options arepossible:

• by MENU key

• by STOP key.

Using STOP the Post Processing window is immediately displayed,selecting MENU the patient selection window will appears.

Select the required patient using UP and DOWN keys.Press ENTER to confirm.


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The window reporting the data relevant to the different runs of the

patient is displayed.Select the desired run using UP and DOWN keys.Press ENTER to confirm.

The post processing window appears:

On this window, in addition to the data relevant to patient, acquisitionmodality, anatomic program etc, the following information is present:

• ROI used to acquire the present run

• Frame rate used to acquire the present run

• I.I. field used to acquire the present run

• mSec exposure time.

In addition to these information the following parameters are present:

• total runs number and run showed

•

total frame number present on the active run and the frame showed• in angio or perif mode only, the mask number selected

• in angio or perif mode only, the sub contrast value

• the windowing level

• the edge level.


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All of them and other settings can be modified using the dedicated keys:

To select run in a patient and frame in a run. The frame keys allow to review a run frame by frameindependently by frame rate acquisition.

To play a run containing more then one frame andto stop the visualization sequence. The frame rate in play mode is the same usedduring acquisition and cannot be modified.

To introduce electronic diaphragm.

When this function is activated (led ON) by usingUP, DOWN, LEFT and RIGHT keys, upper and right shutters will be closed and opened.Using the four arrows contemporarily with SHIFT key the lower and left shutters will be activated. To reset the function press the key.

To reverse the gray scale of image from negative topositive and reverse.

To zoom the present image 4 times. When this function is activated (led ON) by usingUP, DOWN, LEFT and RIGHT keys, it is possible toscroll the enlarged image.

To reset the function press the key. When this function is activated the frames present in the run are displayed with the frame rate used inacquisition. The number of sequence depends by the technical setting. At the end of the last sequence the led turns OFF. Any time the cine loop is required, press the key toactivate the function.

This function is available for exams acquired inangio mode only. When the subtracted image isdisplayed the pixel shift function can be activated by relevant key. The led become ON and the mask position can be modified by 1/8 pixel step. Thismovement is obtained by UP, DOWN, LEFT andRIGHT keys.

This function is available for exams acquired inangio mode only. When the subtracted image isdisplayed the mask can be removed or replaced by means of the relevant key.

This function is available for exams acquired inangio mode only. When a run is scrolling thecontained frames, using this key a new mask can beselected. The mask will be captured at the exact moment when the key is pressed.

This function is available for exams acquired in

angio mode only. When subtracted image isdisplayed it is possible to increase or decrease theimage mask number.


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To modify images characteristics by means of the

relevant keys it is possible to change:− windowing (changing the black and white levels)

− edge enhancement. With AUTO WNDW key the windowing will beautomatically optimized at default level. Pressingreset key any modification described above is reset.

When subtracted image is displayed it is possible toincrease or decrease the image background level by means of the keys on the left side.

In post processing special functions are available inaddition to the functions described. This functionsare described in the next paragraph.


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11.111.111.111.1 Special functionSpecial functionSpecial functionSpecial function

When the post processing modality is activated by means of the SPECIAL FUNCTION key the lower part of the window:

is represented as in the above figure.By means of the UP and DOWN key it is selectable one of the four specialfunctions available:

• overwrite

• angle measure

• length measure

• test pattern display.

• Overwrite

Allows to report comments on the image. To position the cursor onthe required place use UP, DOWN, LEFT and RIGHT arrow keys.Press ENTER key to confirm when the text insertion is completed.Changing the image or using STOP key, the text inserted is cancelled.

• Angle measure

Allows to take a measure of the angle of a part of image.Using UP and DOWN keys select the approx level from the table topon which the part to be measured is located between the 3 levelsproposed 0, 10 or 20 cm. Press ENTER to confirm.

To position the cursor on the required place use UP, DOWN, LEFT and RIGHT arrow keys.Press ENTER key to confirm the starting measuring point. Move the

cursor on the angle vertex and confirm whit ENTER. Move the cursor


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at the end of second segment of the angle, the angle value is

displayed.Changing the image or using STOP key, the text inserted is cancelled.

WARNING:Because of different reasons ( II deformation, error in the level organposition and others) the angle value obtained are only indicative. Do not use this value for diagnostic purpose.

• Length measure

Allows to take a measure of a part of the image.Using UP and DOWN keys select the approx level from the table topon which the part to be measured is located between the 3 levelsproposed 0, 10 or 20 cm. Press ENTER to confirm.

To position the cursor on the required place use UP, DOWN, LEFT and RIGHT arrow keys.Press ENTER key to confirm the starting measuring point. Move thecursor on the final measuring point and confirm with ENTER, thelength value is displayed.Changing the image or using STOP key, the text inserted is cancelled.More than one measure can be done on the same image. To do that repeat the above described steps.

Ratio between 2 measure can be done selecting the relevant window.

WARNING:Because of different reasons (II deformation, error in the level organposition and others) the measures obtained are only indicative. Do not use this value for diagnostic purpose.

• Test pattern

Allow to display a test pattern to adjust correctly the monitor

brightness and contrast.Starting with any modality the test pattern is reset from monitor.


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11.211.211.211.2 Multi imageMulti imageMulti imageMulti image

When the patient menu window is displayed, multi image function can beused.It is a short and easy way how to select the run to be review.

Using the key, on monitor the first image of any run present intothe selected patient is displayed.

By means of the UP, DOWN, LEFT and RIGHT arrow keys, select thedesired run and press ENTER to confirm.

The run selected will be displayed in full screen mode.


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11.311.311.311.3 Image printImage printImage printImage print

If DIVA-D is not equipped with DICOM module, it is possible to send theimage to a laser printer directly.

The image present on display is also present on the printer output channel.

To capture this image it is necessary to confirm from the printer keyboard supplied by the printer manufacturer.

NOTE:Do not change the image displayed until the laser printer acquisition is

completed.


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USER’S MANUAL DICOM functions

(Rev. 0) DIVA-D43

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DICOM FUNCTIONSDICOM FUNCTIONSDICOM FUNCTIONSDICOM FUNCTIONSIf the DIVA-D is equipped with DICOM module, the DICOM key is active.By means of this key the following window is displayed:

Depending from the license present the following functions can beactivated:

• print (to send images to a DICOM laser printer)

• store (to send images to a Pac’s via network)

• CD-ROM (to burn CD-ROM with images).

In addition to these functions another software package can be present:

• waiting list.


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12.112.112.112.1 Waiting listWaiting listWaiting listWaiting list

This function is allowed if the network is equipped with HIS/RIS. When new patient window is displayed (chapter 7) the waiting list selection is allowed.Confirm by ENTER, the window

is displayed.On this window the patients present on the worklist are displayed.By means of the UP and DOWN arrow key select the desired one, pressENTER to confirm.

The patient data window will be displayed (chapter 7) reporting all data inserted in HIS/RIS.By this function any manual patient data entering is avoided.


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12.212.212.212.2 Queue view and flushQueue view and flushQueue view and flushQueue view and flush

To enter into DICOM functions the dedicated key must be used. The window

will be displayed.

If no queue error or messages are present, the last used function will beproposed, anyway the queue view will be reachable by means of ENTER key directly.In any case UP and DOWN arrow keys can be used to reach the functiondesired or queue view.If errors or messages are present in the queue, the relevant field is with

white background; pressing ENTER key the window

will appears.


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The queue list will be showed and erasable.

To cancel the list, using UP and DOWN arrow keys, activate FLUSHfunction and confirm with ENTER key.


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12.312.312.312.3 PrintPrintPrintPrint

When DICOM window is selected, the last function used in DICOM modeis proposed.By means of UP and DOWN arrow keys select the required function andconfirm with ENTER key.If print function is selected the printer window selection is showed.

With UP and DOWN arrow keys, select the required printer and confirm. With LEFT and RIGHT arrow key select the film subdivision and confirm. The DICOM print window

is displayed.Select the image required and modify, if necessary the characteristic asin standard post processing mode.In the lower section of the window, the frame number and position aredisplayed.


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To add the image, the key must be pressed 2 times. After the first time the window

is displayed.Pressing once more the addition is confirmed and the image stored intoDICOM print temporary archive.

The previous window will be showed allowing a new image addition. When the above window is present, 3 other functions are available (useUP and DOWN arrow keys to select and press ENTER to confirm):

• Delete & exit

To reset the temporary DICOM print archive and exit from DICOMfunctions.

• Study print

To print the image stored.

To print the study it is also possible to press 2 times the key starting from the main DICOM print window.

• Change frame

To store the present image instead of an image already present intothe DICOM print archive.

To do that use LEFT and RIGHT arrow keys, the white portion of thefilm will be moved on the film representation showing the place on

which the present image will be located.Press ENTER to confirm, the previous image will be erased and thenew one stored.


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12.412.412.412.4 StoreStoreStoreStore

By means of UP and DOWN arrow keys select the store function andconfirm with ENTER key.

When store function is selected the window is showed:

On the lower part of the window the following information are listed:

• Total Mbytes

Mbytes used by the images stored in the present DICOM store study. This is referred to the temporary DICOM archive.

• Total Patient

This value can be 0 or 1. As matter of fact a DICOM study to be stored cannot contain morethan 1 patient.

•

Total runsIs the number of runs stored to be transferred in the network.

• Total frames

Is the number of single image to be transferred in the network.

• Total sub-runs

Is the number of sub-runs stored to be transferred in the network.


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12.512.512.512.5 CD - ROMCD - ROMCD - ROMCD - ROM

By means of UP and DOWN arrow keys select the CD-ROM function andconfirm with ENTER key.

When CD-ROM function is selected the media type window is showed:

allowing to select the CD-ROM format between High resolution1024x1024 or High speed 512x512.High resolution saves images with 1024x1024 matrix but for staticimages only.High speed has matrix 512x512 but is capable to store images up to25 images/sec.By means of UP and DOWN arrow keys select the media type requiredand confirm with ENTER.


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The following window will be displayed:

On the lower part of the window the following information are listed:

• CD free space

The disk percentage space still available.

• Total Patient

This value can be 0 or 1. As matter of fact a DICOM study to be stored cannot contain morethan 1 patient.

• Total runs

Is the number of runs stored to be transferred in the network.

• Total frames

Is the number of single image to be transferred in the network.

• Total sub-runs

Is the number of sub-runs stored to be transferred in the network.


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To store into temporary DICOM archive, select the patient, the run or the

image required and press ENTER. The window:

is displayed.By means of UP and DOWN arrow keys select if the memory addition will

be of the showed frame only, of the run or of the total patient.

Press ENTER to confirm.

The previous window will be showed allowing a new addition. When the above window is present, 2 other functions are available (useUP and DOWN arrow keys to select and press ENTER to confirm):

• Delete & exit

To reset the temporary DICOM CD-ROM archive and exit fromDICOM functions.

• Burn disk

To send the study stored to CD-ROM.

Before to select "burn disk", put a new CD-ROM into driver and press

key. The dicomization procedure will start and at the end of this operation theCD-ROM burning start.

This sequence is displayed on the window with a waiting notice.

NOTE:If no CD-ROM or not valid one is present into the driver, an error will be

present in the queue.DIVA-D will try again to access the CD after 30 sec.Insert a valid CD-ROM into the driver before a new writing attempt.


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USER’S MANUAL Maintenance and cleaning

DIVA-D (Rev. 0)54

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MAINTENANCE AND CLEANINGMAINTENANCE AND CLEANINGMAINTENANCE AND CLEANINGMAINTENANCE AND CLEANINGLike all electrical device, this equipment requires periodical checks.

This will insure an efficient and correct functioning for years to come.

This equipment is made up of electrical and electronic parts that need to be checked out in order to guarantee high quality radiological results asdescribed in previous chapter.

The maintenance and cleaning procedures described in this chapter must be done by the user.In addition to the above, the authorized service technician will have toperform the maintenance actions described in the Service Manual.

WARNING:

• Before proceeding with the cleaning of the equipment, disconnect it from the mains.

• Make sure that water and any other liquids are not spilled inside theequipment as this may cause corrosion and short circuits.

• Clean the painted surfaces by using a moist cloth and neutraldetergent, taking care to wipe them by using a dry cloth. Do not use

solvents (alcohol, petrol, and trichloroethilene) or corrosive or abrasive products.

13.113.113.113.1 Frequency of maintenance and cleaning actionsFrequency of maintenance and cleaning actionsFrequency of maintenance and cleaning actionsFrequency of maintenance and cleaning actions

Frequency Description

1 month Check the presence of labels and their condition

1 months Check of the image quality.

6 months Clean the monitors and the external parts.

6 year Visual checking of the status of the interconnection cablesand relevant connection.


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diva-d (user's manual)

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