Product Data

STRATO 2000 Digital

Panoramic X-Ray System with CCD sensor

General Features
Movement technology:
Patient positioning:
Patient alignment:

multi-motor with digital trajectory control

face to face
through three laser pointers that allow to locate the three
reference planes: mid-sagittal, Frankfurt, canine

Standard Examination Programs

In each program the compensation for the spinal column is obtained by means of exposure
parameter modulation, optimized in accordance with the selected anatomic program.
Adult panoramic
Child panoramic with trajectory optimization and exposure parameter reduction
Adult hemipanoramic (right and left)
Child hemipanoramic (right and left)

Optional Examination Programs DXP Package

The optional DXP (Digital eXtended Programs) expansion package allows to expand the Strato
2000 Digital standard performances, both in basic and ready for CEPH configurations, with
new examination programs that are especially designed for several different applications.
The package includes:
TMJ Temporo-Mandibular Joint study

Open/close mouth TMJ: 4 views are taken on the same image: left/right condyle,
open/close mouth. Condyles are examined in lateral projection
Bi-axial TMJ: 4 views are taken on the same image: left/right condyle,
longitudinal/oblique projection. One projection is parallel to condyle long axis, the other is
angled at 40 with respect to the first.

SINUS Study of Paranasal Sinuses

Maxillary sinus P-A: one P-A projection, where both maxillary sinuses are shown.
Possibility to correct the position of the layer by +/- 7mm.
Maxillary sinus L-L: L-L projection of right or left maxillary sinus.
Possibility to correct the position of the layer by +/- 3mm.
Every examination is obtained implementing a stratigraphy method with high layer thickness.
If selected patient type is Child, layer position is additionally optimized.

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A.D.A. Advanced Dental Applications

Frontal dentition: panoramic limited to the frontal dentition (canine to canine), that allows to improve the detail definition on incisors.
Low dose panoramic: panoramic with reduced angle of rotation to exclude the ascending
ramus from the image. The result is a panoramic limited to the dentition area using a reduced patient dose.
Improved orthogonality dentition: panoramic projection limited to the dentition obtained with X-ray beam constantly perpendicular to the arch. It reduces superimposition of
adjacent teeth and improves visualization of possible interproximal caries.

IMPLANT EXAM Linear tomography for implantology

IMPLANT 2: 1 longitudinal section + 1 transversal section
IMPLANT 4: 1 longitudinal section + 3 transversal sections
Images size: max 5X15cm, depending on the exam
Longitudinal layer thickness:
6 mm
Transversal layer thickness:
6 mm
Distance between transversal layers:
3 mm (only for Implant 4)
Two dedicated bites are included to execute exams of mandibular and maxillary arches.
Note: The target tooth for the transversal section is selected via the keyboard by entering the
tooth number (according to International or US numbering system).
Patient is maintained in frontal position independently from the selected target.
Examination of incisors (elements 11, 12, 21, 22, 31, 32, 41, 42) can be performed with
limitations on patient size.

Digital Cephalometric Examination

Strato 2000 Digital is available in two configurations:

Panoramic only

Ready for digital CEPH
The CEPH-ready version has automatic alignment of x-ray source on digital sensor and can be
upgraded with the ceph arm at any time directly in field.
The addition of CEPH arm allows to take cephalometric examinations on a second sensor
dedicated to this kind of application. Thanks to this configuration the equipment is always
ready for both PAN and CEPH exams, without the need to move the sensor and so without the
risk to drop it, guaranteeing the maximum sensor protection.
The digital cephalometry is based on a linear scanning technique, obtained maintaining the
focus in a fixed position, guaranteeing the same projection geometry as if using film. The X-ray
beam moves in horizontal direction maintaining the alignment with the sensor.
It can be executed in two modalities, selectable from console:
- high resolution (2x2 binning), for the enhancement of the finest details
- high speed (3x3 binning), for patient dose reduction and for the decrease of artifacts
due to possible patients movements.

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The system allows the following projections:

Application
Images formats
Skull Latero-Lateral
Skull Antero/Posterior or
Postero/Anterior
Skull Latero-Lateral, with full view
of the nape
Mainly Latero-Lateral. Can also be
used for AP/PA projections
Hand/wrist examination

18 x 22 cm
Asymmetric
24x22 cm
Symmetric
24 x 22 cm
Asymmetric
30 x 22 cm
Symmetric
18 x 22 cm
Symmetric

Scanning time
(2x2 binning)

Scanning time
(3x3 binning)

9s

4.5 s

12 s

6s

12 s

6s

15 s

7.5 s

9s

4.5 s

Anatomic Programs

Patient type:
Patient size:
Arch shape:

2 choices: adult, child

3 choices: small, medium, large
3 choices: narrow, standard, wide

Image Magnification
Panoramic
1.23 constant*
Open/close mouth TMJ
1.30 constant*
Bi-axial TMJ
1.30 average*
Sinus
1.23 constant*
Cephalometry
1.1 average
Implant
1.26 constant
*Note: the magnification factor is calculated in the center of the focal trough, which is based
on a shape of the mouth-ascending ramus complex, as defined in international literature.

Generator
High frequency generator, constant potential
Ripple
< 4%
Inverter frequency:
30 kHz
High voltage:
- 60 80kVp, step 2 kV for cephalometry
- 50 80kVp, step 2 kV for other exams (including
hand exam)
Anodic current
- 4 12mA, step 1 mA for ceph and hand exam with
high voltage up to 76kV
- 4 10mA, step 1 mA for ceph and hand exam with
high voltage from 78 to 80kV and other exams
Exposure times:
Panoramic:
15 sec adult, 13.5 sec child
Hemipanoramic:
8 sec. adult, 7.5 sec child
Open/close mouth and bi-axial TMJ:
4x 2.65 sec
Maxillary sinus P-A:
10.4 sec
Maxillary sinus L-L:
5.2 sec
Frontal dentition:
7.9 sec
Low dose panoramic:
12 sec
Improved orthogonality dentition:
12 sec
Implant 2
approx 10 sec
Implant 4
approx 20 sec

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High resolution cephalometry

(binning 2x2):

High speed cephalometry

(binninig 3x3):

9 sec for 18x22cm size

12 sec for 24x22cm size
15 sec for 30x22cm size
4.5 sec for 18x22cm size
6 sec for 24x22cm size
7.5 sec for 30x22cm size

X-ray Tube

Focal spot size:

Heat storage capacity:
Total filtration:
Duty cycle:

0.5 (IEC336)
30kJ (40kHU)
2.5mm Al eq.
1:16 (for each second of exposure, 16s of cooling time are
needed).

Collimator

Primary collimator:
Fixed in basic configuration
Mobile in ready for CEPH configuration with automatic selection of the diaphragms PAN
or CEPH
Mobile secondary collimator near to the CEPH group with synchronized movement with
CEPH sensor
Soft tissue filter (copper wedge) enhances profile of the soft tissues of the face on the
lateral skull view. Motorized positioning of the filter can be adjusted to match the contour
of any patient
A radio-opaque reference bar allows measurement calibration

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User Interface

Console with flat and waterproof surface for easy cleaning and disinfection
Back-lighted alphanumeric LCD display with 2 lines of 20 characters
X-ray push button with extensible cable
Each operation is guided by messages shown on the display
The user can choose one of five available languages:
English, Italian, French, Spanish, German.

Keyboard Functions

2
3

11

12

23

22

DISPLAY

28

24

13

25
7

14

15

16

17

27
26

1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.

10

21

20

Ready for exposure signal light

X-ray emission warning light
Manual increase of kV, sec or mA
Manual decrease of kV, sec or mA
Select kV for manual regulation
Disabled
Select mA for manual regulation
Execute exam in test mode without x-ray
emission
Reset
Patient centering position
Anatomic selection: adult/child
Anatomic selection: patient size
Anatomic selection: arch shape
Reserved for future expansions
CEPH program selection

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19

16.
17.
18.
19.
20.
21.
22.
23.
24.
25.
26.
27.
28.
29.
30.
31.

18

29

30

31

SINUS program selection

Reserved for future expansions
Reserved for future expansions
Panoramic programs selection
TMJ open/close mouth programs selection
Bi-axial TMJ programs selection
Centering laser lights
Reserved for future expansions
Cursor movement for parameters selection
Cursor movement for parameters selection
Cursor movement for parameters selection
Cursor movement for parameters selection
Enter key: operation confirmation
Vertical movement: up
Safety key for vertical movement
Vertical movement: down

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Digital Acquisition System

PAN CCD Sensor

Technology:
Sensor size:
Pixel size:
Image matrix:
Sensor resolution:

CCD sensor with Cesium Iodide (CsI) scintillator screen

6x146 mm
48 m (96 m in 2x2 binning modality)
1536 x 2805 pixels in 2x2 binning modality (standard panoramic)
10.4 lp/mm maximum theoretical
5.2 lp/mm with CTF 60% real (in 2x2 binning modality)
Gray levels:
4096 (12 bits) in acquisition (A/D converter)
256 (8 bits) in viewing
Max useful image size: equivalent to a 15x30 cm film

CEPH CCD Sensor

Technology:
Sensor size:
Pixel size:
Sensor resolution:

CCD sensor with Cesium Iodide (CsI) scintillator screen

6x220 mm
48 m (96 m in 2x2 binning; 144 m in 3x3 binning)
5.2 lp/mm (in high resolution modality - 2x2 binning)
3.4 lp/mm (in high speed modality 3x3 binning)
Gray levels:
4096 (12 bits) in acquisition (A/D converter)
256 (8 bits) in viewing
Scanning:
horizontal, with constant speed:
20 mm/sec (binning 2x2)
40 mm/sec (binning 3x3)
Max useful image size: equivalent to a 30x24 cm film

Image Acquisition
Strato 2000 allows to acquire digital images in two different modalities:
1. Direct acquisition through a USB 2.0 connection:
the images and the exposure parameters are transferred from Strato 2000 to the PC via a
high speed USB 2.0 connection (480 Mb/s). The images are seen forming on-screen in real
time during the exposure.
2. Acquisition on memory card Compact Flash
Strato 2000 is equipped with a slot for memory cards Compact Flash type I with 16MB
to 1GB capacity, where the images and the exposure parameters can be stored also without
a direct connection to a PC. The typical capacity of a 128MB memory card is 7 images.
Images stored on the card can be transferred to any PC at any time after the acquisition
using an appropriate card-reader by the QuickVision software.
Use of fast Compact Flash cards is recommended. Images are stored on the cards in a
proprietary format that must be read using the QuickVision software.
The system automatically recognizes where the image can be stored:
- On PC when Strato 2000 is connected to a PC via USB 2.0 connection
- On Compact Flash when the card is in the slot and there is no USB connection
- On both PC and card when a card is in the slot and USB connection is available
The exposure is inhibited when there is no USB connection and no card in the slot.

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QuickVision Software
Strato 2000 digital is supplied with the QuickVision software for image acquisition, storage
and processing.
The QuickVision software is available in 9 languages (English, Italian, French, German, Spanish, Portuguese, Russian, Polish and Chinese) with the following functions:
Patient and Image Archive
Various archives are created including:
- Main patients data
- Exams for each patient
- Radiological parameters set for each exam (kV, mA, sec, anatomical program)
It is also possible to send by email the acquired exams through few mouse clicks on the exams
thumbnails.
Virtual Keyboard
Thanks to a Virtual keyboard reproducing the Strato 2000 console on-screen, it is possible to
set the exposure parameters directly from the PC.
Use of the virtual keyboard and of the on-board console is also possible at the same time.
For safety reasons, the virtual keyboard cannot activate X-ray emission, switch on the laser,
or start any motorized movements.
Exam repetition
A dedicated function allows to repeat an exam using the exposure parameters of a previous
session. The operator selects the exam he wants to repeat, and all the parameters are automatically transferred to Strato 2000.
Image processing
The QuickVision software allows to employ the following functions:
- Image contrast adjustment
- Image brightness adjustment
- Gamma factor adjustment
- Filter for edge enhancement, with possibility to adjust the filter level
- Gray scale equalization to improve the image definition
- Hi contrast
- Embossed view
- 3-D view
- Image rotation (90 and 180)
- Image horizontal inversion
- Pseudo-colors
- Gray scale inversion (Negative/Positive)
- Magnification (up to X32)
- Distance measurement
- Drawing and annotation
- Image hardcopy. Images can be printed on any Windows compatible printer (image quality
may differ according to the printer model). Images are printed with the following parameters:
- Patient data
- Exposure parameters
- Examination date

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Software DAP meter (Dose-Area product)

Irradiated dose is estimated by software according to the exam exposure factors. The dose
data is automatically burnt in each image.
Reading accuracy: 20%
Dicom Connectivity (option)
- If the system is equipped with the optional QuickPrint Dicom Gateway package for QuickVision, images can be printed on any Dicom 3 printer. Images are printed with the following parameters:
- Name of the practice/hospital
- Patient data
- Exposure parameters
- Examination date
-

If equipped with the optional Etiam DicomIzer package, the system guarantees a full connectivity with PACS networks.
It includes:
- PRINT class (for printing on Dicom 3 imagers);
- STORE class (for image transfer to PACS networks);
- WORKLIST class (for automatic retrieval of patients list from RIS/HIS)
- QUERY-RETRIEVE class (for receiving patient data from other modalities)

Etiam DicomIzer package can be completed with the optional Dicom CD for DicomIzer, that
allows to create CD with Dicom images.
Twain Driver (option)
It allows other imaging programs to import images acquired with Strato 2000.
Image Import/export
The software permits import/export of images in jpeg and tiff format.
Image Scan
The software also allows import of images from a compliant scanner.

Minimum Requirements for the PC Hardware

Intel Pentium 4 with Intel Chipset

256MB or more
Windows 2000 with Service Pack 4,
Windows XP with Service Pack 2
Video:
1024x768, 16 Million colors or more
USB port:
compatible with USB 2.0 specification
Compact Flash cards: Strato 2000 Digital is compatible with Compact Flash Type I cards
from 16MB to 1GB.

CPU:
RAM:
Operative system:

NO dedicated PC board is required.

Standard Accessories

Bite Block support

Chin support for edentulous patients
10 bite blocks with supports
2 temple clamps
X-ray push button with extensible cable
2 sterilizable grips

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4 accessory-trays

Optional Accessories

Hardware DAP Meter. It shows the dose delivered to the patient. Factory installation only.
Label printer for DAP meter. It allows to print the dose measure obtained with the DAP meter on paper or adhesive stickers.

Mechanical Characteristics

Source to PAN sensor distance: 510 mm (20) (panoramic, TMJ, Sinus, A.D.A.)
Source to CEPH sensor distance:
1650 mm (65)
Vertical column movement:
670 mm (26.4) , motorized
Weight
Version without ceph arm:
135kg
Version with ceph arm:
160kg
Total height max:
2320mm (91.3)
Length x Width
Versions without ceph arm:
1000x1250mm
Versions with ceph arm:
1820x1250mm
Operating surface
Versions without ceph arm:
1300x1300mm
Versions with ceph arm:
1950x1300mm
Type of installation:
wall mount

Electrical Characteristics
Power supply voltage
Frequency
Current rating
Power rating

220/230/240 Vac (10%)

single phase
50/60 Hz
8A @ 230V
2kVA

120 Vac (10%)

single phase
50/60 Hz
15A @ 108V
2 kVA

Environmental Characteristics
Operating temperature
Operating relative humidity
Operating atmospheric pressure
Transport and storage temperature
Transport and storage relative humidity
Transport and storage atmospheric pressure

+10C +40C
30% 75%
700 1060 hPa
-20C +70C
<95 % non condensing
500 1060 hPa

Standards and Regulations

This product is designed and produced to meet the following standards:
EN 60601-1, EN 60601-1-1, EN 60601-1-2, EN 60601-1-3, EN 60601-2-7, EN 60601-2-28
CE symbol grants the product compliance to the European Directive for Medical
0051
Devices 93/42 as a class IIB device
FDA approval grants the product compliance to USA Standards.
(Only for 120V version)
Medical Devices Regulations, Section 36 (Canada) (Only for 120V version)

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10931763

15

10561726

11101780

Dimensions (indicated in mm)

Note: Products are continuously under review in the light of technical advancement. The actual specification may therefore be subject to improvement or modification without notice.

Company with Quality System certified by

DEL Medical Systems Group

VILLA SISTEMI MEDICALI s.p.a.

60131 Franklin Park IL - USA

11550 W. King Street
Tel.+1-847-288 7000 Fax +1-847-288 7011
www.delmedical.com

20090 BUCCINASCO (MI) ITALY

Via delle Azalee, 3
Tel. +39 02 48859.1, Fax +39 02 4881844
ISO 9001:2000

STRATO 2000 Digital - Product Data Rev.6

ISO 13485

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