ECLYPSE TECH File ENG Rev 0.5

Via Marzabotto, 21 / 23
20871 VIMERCATE (MB) Emission date: 12-07-11

Tel. 039/6080443 Revision date: 31-10-14 (R 0.5)
Fax 039/6082557
ECLYPSE
TECH FILE
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Commercial Name ECLYPSE - Radiologic Room
REF ECLXXX
ECLYPSE, properly installed, allows to perform radio-

diagnostic examinations, common and specialized.
The medical device is intended to realize radiological
Intended Use images on film or other support, by mean of ionizing
radiations. ECLYPSE is intended to be used for
images on bone tissues, soft and cartilaginous tissues
with diagnostic purposes only.
Technical Feature Page 5 and followings
Nothing, within the limits of the intended use of the

product. The medical device can be used only by
Unintended Effect
skilled medical personnel with proper qualification.
Carefully read the user manual
Each medical device is tested in the factory, before

shipment, according to the document “Factory
Factory acceptance acceptance test”. After installation, the manufacturer
test set a second test with release of the installation
report. Applicable norms are mentioned in
Declaration of conformity sent along the device
Each packaging is identified with a specific label

reporting product description and reference data of
the product (code and batch).
The medical device “ECLYPSE” when passed the final
Packing factory test (product release) is packed in such a way
to preserve it until the moment of use.
Standard procedure set the shipment of the device in
cage or box, with preventive use of pluriball and
plastic film.
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In designed according to UNI 980, a copy of the label

Labelling
in on the user manual and technical manual.
This medical device must be managed in

full respect of Article 13 of Dlg July 25,
2005, Nr 151 ’’Attuazione delle direttive
Disposal 2002/95/CE, 2002/96/CE e
2003/108/CE,” related to the reduction of
the use of the dangerous material on the
electrical and electronic devices, as well as
to the garbage disposal.
The medical device is in class IIb according to

CE Mark 93/42/CEE and further modification and integrations
(2007/47/CEE).
Certificate n°878/MDDreleased by IMQ (notified body

CE Certification
0051)
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ECLYPSE medical device is commercialized with 6

codes, each with possible variation. Available codes
are:
ECL001, ECL002, ECL003, ECL004, ECL005,

ECL006
Each code is given the type of devices that composes

the ECLIPSE, for instance ECL001 is composed by:
• DTRXXX (chest stand),
• ETSXXX (tubestand),
• AINXXX(bucky table),
• Generator,
• Tube
• Collimator.
Product family
See below table that resume the codes:
CODE DESCRIPTION
DTR, ETS, AIN, GENERATOR, TUBE,
ECL001
COLLIMATOR
DTR, ETS, GENERATOR, TUBE,
ECL002
COLLIMATOR
DTR, ETS, GENERATOR, TUBE,
ECL003
COLLIMATOR
ETS, AIN, GENERATOR, TUBE,
ECL004
COLLIMATOR
DTR, ETS, AIN, GENERATOR, TUBE,
ECL005
COLLIMATOR
ECL006 ETS, GENERATOR, TUBE, COLLIMATOR
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TECHNICAL FEATURES
CHEST BUCKY - DTRXXX
DTR600
Features and encumbrances dimensions.
- Stand fixation on wall
- Vertical potter bucky movement 1550 mm
- Minimum distance from floor of imaging area 400 mm
Maximum distance from floor of imaging area 1950 mm
- Vertical movement balance Counterweight
- Vertical movement brake mechanical
- Standard potter bucky grid R 10 - 120 l/”
f.d. 150 cm
- Film to patient skin distance 40 mm
- Device Weight 105 kg
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DTR601
Features and encumbrances dimensions
- Stand fixation Floor and wall

- Vertical potter bucky movement 1550 mm
- Minimum distance from floor of imaging area 418 mm
Maximum distance from floor of imaging area 1 1968 mm
- Standard potter bucky grid R 10 - 120 l/”
f.d. 150 cm
- Film to patient skin distance 40 mm
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DTR604
- Stand fixation on wall
- Vertical detector movement 1550 mm
- Minimum distance from floor of imaging area Depends on
digital detector
- Maximum distance from floor of imaging area 1550+X mm
- Digital detector size
- Standard grid Depends on digital
- Film to patient skin distance detector
- Power supply
X = Depends on
digital detector
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DTR605
- Stand fixation On floor

or on wall
- Vertical detector movement 1550 mm
- Minimum distance from floor of imaging area Depends on
digital detector
- Maximum distance from floor of imaging area 1550+X+18mm
- Digital detector size
- Standard grid Depends on digital
- Film to patient skin distance detector
- Power supply
X = Depends on
digital detector
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TUBESTAND - ETSXXX
ETS001
- Longitudinal Movement 1850 mm

- Longitudinal Movement brake electromagnetic
- Tube/housing movement:
o Rotation around support axis ± 180 ° continuous
Memories every 90°
o Transversal movement NO,static distance 650mm
from the tube stand
o Vertical movement 1650 mm
- Minimum distance X-ray beam to floor 400 mm

- maximum distance X-ray beam to floor 2050 mm
- Tube/housing movement brake electromagnetic
- Stand rotation on its axis NO
- Stand rotation Brake -
- Power supply 24 Vdc – 90VA
- Device weight 210 kg with the collimator
All the following measures are in millimetres:
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ETS002

Memories every 90°
o Transversal movement NO,static distance 650mm
from the tube stand

- Stand rotation on its axis ± 180°
- Stand rotation Brake mechanical
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ETS003

Memories every 90°
o Transversal movement from 580 to 780mm
centre at 680mm
from the tube stand

- Stand rotation on its axis NO
- Stand rotation Brake -
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ETS004

Memories every 90°
o Transversal movement from 580 to 780mm
centre at 680mm
from the tube stand

- Stand rotation on its axis ± 180°
- Stand rotation Brake mechanical
- Device weight 210 kg with the
collimator
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BUCKY TABLE - AINXXX
AIN001
- Tabletop X-ray transparent Laminate

- Tabletop adsorption 0,9 mm Al equivalent
- Tabletop size 2200x810 mm
- Tabletop longitudinal movement 900 mm
- Longitudinal movement brake electromagnetic
- Tabletop transversal movement ± 110 mm
- Transversal movement brake electromagnetic
- Tabletop height 730 mm
- Potter-Bucky movement 550 mm
- Potter-Bucky movement brake electromagnetic
- Film tabletop distance 70 mm
- Standard grid R10-120 L” d.f.120 cm
- Accepted cassette size min13x18cm – max35x43cm
(both directions)
- Max Patient weight accepted 200 kg
- Table Power Supply ( cable lgt. 15m) 230Vac – 50/60Hz – 0,75KVA
- Device weight 152 Kg
AIN004
- Tabletop X-ray transparent Laminate

- Tabletop adsorption 0,9 mm Al equivalent
- Tabletop size 2200x810 mm
- Tabletop longitudinal movement 900 mm
- Longitudinal movement brake electromagnetic
- Tabletop transversal movement ± 110 mm
- Transversal movement brake electromagnetic
- Tabletop height 730 mm
- Digital detector movement 550 mm
- Digital detector brake movement electromagnetic
- Detector tabletop distance Depends on digital detector
- Grid (optional) R10-215 L” d.f.120 cm
- Max Patient weight accepted 200 kg
- Power Supply ( cable lgt. 15m) 230Vac – 50/60Hz – 0,75KVA
- Device weight 152 Kg
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Encumbrances of the radiological table AIN (all versions)
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ECLYPSE TECH File ENG Rev 0.5

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Via Marzabotto, 21 / 23

20871 VIMERCATE (MB) Emission date: 12-07-11

Commercial Name ECLYPSE - Radiologic Room

ECLYPSE, properly installed, allows to perform radio-

Technical Feature Page 5 and followings

Nothing, within the limits of the intended use of the

Each medical device is tested in the factory, before

Each packaging is identified with a specific label

In designed according to UNI 980, a copy of the label

This medical device must be managed in

The medical device is in class IIb according to

Certificate n°878/MDDreleased by IMQ (notified body

ECLYPSE medical device is commercialized with 6

ECL001, ECL002, ECL003, ECL004, ECL005,

Each code is given the type of devices that composes

CHEST BUCKY - DTRXXX

- Stand fixation Floor and wall

- Stand fixation On floor

- Longitudinal Movement 1850 mm

- Minimum distance X-ray beam to floor 400 mm

All the following measures are in millimetres:

- Longitudinal Movement 1850 mm

- Minimum distance X-ray beam to floor 400 mm

All the following measures are in millimetres:

- Longitudinal Movement 1850 mm

- Minimum distance X-ray beam to floor 400 mm

All the following measures are in millimetres:

- Longitudinal Movement 1850 mm

- Minimum distance X-ray beam to floor 400 mm

All the following measures are in millimetres:

BUCKY TABLE - AINXXX

- Tabletop X-ray transparent Laminate

- Tabletop X-ray transparent Laminate

Encumbrances of the radiological table AIN (all versions)

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