Zeta - Service
Zeta - Service
ZETA
SERVICE AND MAINTENANCE MANUAL
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WARNINGS
All users of ZETA unit described herein are strongly recommended to read carefully all instruction
in this manual and to respect recommendations reported about safety before attempting any
operation of installation, service or use of these devices.
Installation, service and maintenance of all devices which are part of the system is reserved to
technical personnel, qualified and trained, with adequate experience and professional background.
Even if the unit ZETA unit has been designed and manufactured to ensure utmost safety during
use, installation and examination, a lack of respect of the indication herein reported can result in a
potential risk for user patient and things.
The system configuration must not be changed during the lifetime of the device.
An excess of X-Ray dose is a well known risk for health, and an improper use of Radio diagnostic
devices can result as well in a possible risk for health of patient and user.
Users of X-ray units, like those described in this manual, and technicians in charge of installation
and maintenance, are mandatory required to be informed on risk connected to exposure to an
excess of direct and diffracted X-rays and to keep safe themselves as well as patient and all
people eventually exposed to the same risk. A proper use of all standard means of protection is
needed in this purpose.
Specifically is mandatory that users and all personnel eventually required in the radiological room
will be informed on the International regulations for X-Ray protection and respect all indication
mentioned there.
SPECIFIC WARNINGS
All mechanical components and mobile parts which are included in the standard featuring of this
unit shall be used carefully and precisely, in respect of what described herein and according to the
indication of the present manual. A lack of respect of these indications may result in a collision
with patient, users, other operator or object present in the X-Ray room.
It is forbidden for all non authorized personnel to access to the internal part of the devices,
especially removing protective cores and carters: only skilled and qualified personnel can remove
these carters and attempt intervention to powered parts or other components for ordinary and
non ordinary maintenance.
It’s requested utmost attention and care while using mobile phones, sources of electro-
magnetic radiation and other potential sources of interferences to electrical and
electronic components. Given the medical device ZETA is not in need of any specific
shielding to ensure safety, use of such devices like those here mentioned should be
prohibited in the immediate proximity of the medical device and, in every case, in the X-
Ray room.
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The content of the present manual, technical, planning and design, is an intellectual property of
CAT MEDICAL SYSTEMS .
Readers are required to contact directly CAT MEDICAL SYSTEMS and mention all violation to this
right, may it be in form of unauthorized copy, improper diffusion or other.
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INDEX
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ZETA is an X-ray unit that is combined with other devices to compose a general
radiological system for clinical diagnosis on patient. Typical application is intended
with patient in vertical position.
The chest bucky ZETA, is intended with use exclusively in a hospital environment,
only operated by technical skilled personnel.
Description:
Chest bucky designed for exam on vertical detector, to ZETA could be coupled an
external tray for non-standard detector (see the detail below). It is equipped with
a support for digital or analogue detector.
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In order to realize a complete X-ray diagnostic system, ready to work, the ZETA
unit here described will require connection with an X-ray generator, an X-ray
source, a collimator, and HT cables.
The medical device ZETA can be combined with devices that may or may not be
manufactured by CAT MEDICAL SYSTEMS itself. In case of combination with a
device not manufactured by CAT MEDICAL SYSTEMS, it is mandatory to contact
CAT MEDICAL SYSTEMS itself to check compatibility with ZETA. In any case, all
devices used in combination with ZETA must be CE marked and conform
to international rules and laws for safety.
Warning
In the eventual combination of CAT MEDICAL SYSTEMS devices with other
manufacturer devices (main elements and accessories), please check
compatibility through these pages: where no mention of clear compatibility is
declared in this manual the user is required to check the conformity to the
mentioned norms and regulations and the eventual presence of non predictable
risks due to lack of compatibility between the devices.
It is mandatory to contact CAT MEDICAL SYSTEMS in this connection, as well as
the manufacturer of each device.
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Here follows the list of devices for which CAT MEDICAL SYSTEMS has already
checked and approved compatibility:
• Collimator:
o Manufacturer: Ralco
Model: “R302/A”
o Manufacturer: IAE
Model: “C52”
Model: “C52s”
Model: “C352”
Model: “C100”
o Manufacturer: Dunlee
Model: “DR1817”
Model: “DR1825”
Model: “DR1833”
Model: “DR1429”
Model: “DR1436”
Model: “DR1492”
Model: “DR1494”
o Manufacturer: Toshiba
Model: “E7239x”
Model: “E7864X”
Model: “E7869X”
Model: “E7252X”
Model: “E7813X”
• HT Generators:
o Manufacturer : PSM,
Model “gamma GX 600”
Model “gamma GX 350”
Model “gamma MX 350”
o Manufacturer : ODEL
Model “Gamma Program US”
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o Manufacturer : DRGEM
Model “Gamma Arval” (ARCOM brand)
Model “Gamma GXR”
o Manufacturer : CPI
Model “Gamma INDICO ” (ARCOM brand)
Model “Gamma CMP”
o Manufacturer: Provotech,
Model “00512501+70151”;
• Ionization Chamber:
o Manufacturer Claymount
Model “SSMC 601”;
Model “SSMC 604”;
• Digital Detector:
o Manufacturer ATLAIM
Model “ATAL 8”;
o Manufacturer Schaef Systemtechnik GmbH
Model “DRF-R4343C + Vario X-Ray”
• Medical Monitor:
o Manufacturer WAVERIC
Model “MM20A”;
• PACS Software:
o Manufacturer PROTEC
Model “PROPAXX”;
o Manufacturer Schaef Systemtechnik GmbH
Model “Vario Store + Vario Image”
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This medical device is fully compatibility to every tube supported by the following
tube case:
MANUFACTEREUR MODEL
Toshiba e7239x
Dunlee x1300
Dunlee rot350
Dunlee du1817
Dunlee du1750 a 90°
Variant Emerald/Diamond
Variant b130
Siemens ray-12s
Siemens SV150
Siemens Optilix
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CODE DESCRIPTION
Chest Bucky without base-plate, with Potter Bucky and anti-
Type 0
scattering grid.
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ZETA Type 0
Features and encumbrances dimensions.
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ZETA Type 1
Features and encumbrances dimensions
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ZETA Type 4
Features and encumbrances dimensions
- Stand fixation on wall
- Vertical potter bucky movement 1360 mm
- Minimum distance from floor of imaging area Depends on digital detector
- Maximum distance from floor of imaging area 1760 mm
- Vertical movement balance Counterweight
- Vertical movement brake mechanical
- Digital detector size
- Standard grid Depends on digital
- Film to patient skin distance detector
- Power supply
- Device Weight 90 kg
X = Depends on
digital detector
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ZETA Type 5
Features and encumbrances dimensions
- Power supply
- Device Weight 110 kg
X = Depends on
digital detector
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ZETA X-ray devices are designed and manufactured in conformity to the Dlg
46/97, that receipt the EU Directive 93/42/CEE, and further modification and
integration such as those provided by the Dlg 25 January 2010, n. 37, that
receipt the EU Directive 2007/47/CE. ZETA devices have been classified as
Medical Devices in Class IIb.
The medical device “ZETA”, subject of this manual has been classified as active
medical device in Class IIb, according to rule 10, of 3rd paragraph that refer to
additional rules applicable to active medical devices, in annex IX of the Dlg 46/97,
that receipt the EU Directive 93/42/CEE, and further modification and integration
such as those provided by the Dlg 25 January 2010, n. 37, that receipt the EU
Directive 2007/47/CE.
Hence the last comma of rule 10 states what follows “devices intended to emit
ionizing radiation and designed for diagnosis, radiotherapy or interventional
radiology, including those devices that controls them or directly influence their
performances are included in class IIb” . The device subject to this document, has
a direct influence on the result of radio diagnostic applications: as a matter of
fact, as it includes proper patient positioning means and acting as direct
influence in the imaging process, it falls into given definition.
Classification rationale
The chest stand ZETA includes for a proper use an Anti scatter grid, intended to
be installed between the X-Ray source to reduce the diffracted radiation affecting
the surface and so improving the image contrast of the primary image. As a
consequence, the device is directly influencing the performance of the ionizing
radiation.
Moreover the potter bucky and the digital pack are both in direct connection with
the generator, influencing the X-Ray emission moment and duration, which are
not going to happen if not after a proper “go” signal form the Potter or the Digital
Pack.
Finally the Al equivalent filtration of the front panel and the homogeneity of the
material has a direct influence on the image quality, considering also the
importance given to this point by the technical norm CEI EN 60601-1-3 that
verifies the attenuation in equivalent Al mm and determines a max value. A
proper material used to hold the patient and so positioned between patient and
detector, avoid an excess of attenuation that may result in a high value of dose
needed to achieve the desired image.
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The product has a life period of 20 years, shelf life depends on the use made out
of the product and on the level of maintenance and consumption.
Rule application
The chest bucky ZETA is CE Marked in conformity to what stateri annex II of
MDD 93/42, as described in art.11 and respond to all essential requirements in
annex I .
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V - Safety
The X-Ray units ZETA must be used only by qualified and duly trained personnel,
in respect of what specified in this manual about safety.
In all cases when the ZETA units are combined and made working with devices
from other manufacturer, the compatibility of those devices must be specified in
this manual and the user is required to take care that no risk can be generated to
patients and users.
The X-Ray units ZETA requires ordinary, periodic operation of cleaning and
maintenance, as specified in the appropriate section of this manual.
CAT MEDICAL SYSTEMS declines all responsibility for damages occurred to things
or human beings as well as for risky situation caused directly or indirectly by:
o Improper use of the system or use that differs in any way to what
described in this manual,
o Installation of the units performed in a different way than what stated in
this manual
o Maintenance and service operations are not performed in respect of what
stated in this manual
It is here reminded that CAT MEDICAL SYSTEMS is responsible of the safety of its
products only if Installation, service and repair operations are performed by
technically skilled personnel authorized by CAT MEDICAL SYSTEMS with a suitable
training course.
The medical devices ZETA don’t have any protection class because are not
directly by the power supply, the only part supplied are the detector (for the
detail see their manual).
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The Chest Bucky ZETA is not provided of safety devices that may impede an
eventual collision with any object and person present in the radio diagnostic
room.
By mean of this it is requested the utmost attention from the operator during the
use.
It is full responsibility of the installation staff to ensure that the installation site
has adequate protection for the ionizing radiation. The user has mandate to check
that this obligation is fulfilled properly.
It is full responsibility of the user to evaluate the effects which may result by an
exposure o x-ray radiation, direct and diffracted, and provide in order tot have
the exams conducted in respect of the safety radioprotection norms, especially
for what is up for:
- Use of stationary and mobile barriers and shields, which shall be given in
the installation.
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- Use of adequate leaded anti X clothes such as gloves an collars any time
the user is necessary aside of the patient during the examination. Please
note to always have care of being out of the primary field.
- Check the perfect closure of the doors for access and exit to the X-Ray
room. Always have care to leave in the x-ray room only the people strictly
necessary for the good result of the examination
- Check correct use and positioning of the personal dose measurer of the
personnel, according g to the indication of the radioprotection specialist.
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VI - Unpacking
ZETA unit is packed singly and protected in a wooden cage or in a wooden crate,
the dimensions and the unpacking procedure are the same for both type of
packing.
Dimensions:
• 2120x850xh570mm
Weight:
• Cage Kg.48
• Crate Kg.68
To move this type of packing is mandatory to use proper gear (for example a
pallet truck).
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2. Remove the top cover unscrew all the screws in the top
3. Remove, if present, the workstation, all the parts of the Digital Pack and
the accessories from the package.
4. Remove the ZETA unit from the cage/crate with, fro example, a pallet truck.
5. Remove the internal protection (plastic film, adhesive band, cardboard and
so on).
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VII - Installation
Verify that the room of destination of the X-Ray units has dimensions and
structures wide enough to host the devices, considered the encumbrances already
described in this manual and the need for installation of an X-ray generator and
its control console. As well, verify that the room allows hosting all accessories and
other objects eventually needed for examination.
It is important to check that around the X-ray devices is kept enough free space
to allow the operator movement and to avoid collision with things and people.
When an X-ray transparent stretcher on pivoting wheels is used with the system,
a specific care is required to verify room dimensions. It is important to check that
the room will save enough space for stretcher access and movement inside the
room.
Moreover verify all component and devices not manufactured by CAT MEDICAL
SYSTEMS, needed for the use of the X-ray system, (such as the X-ray generator
or the X-ray tube) and other accessories eventually designed to be host in the
room in association with the X-Ray system. All these objects must respond to the
following parameters:
For what concerns the elements which are not part of the functional configuration
of the system, which have anyway a use during some examination (e.g. service
stool) and some furniture elements (such as wardrobes or desktops): for all these
elements take care that their presence will not result as an obstacle for device
movement and ordinary work of the system.
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Room features:
The room designed for installation of the system must respond to the following
features:
- Conformity and certification in line of international and local laws for room
designed to host an X-Ray source
- Electric plant in line of international and local laws, and according to all
devices designed to work in the base of the same power plant. For CAT
MEDICAL SYSTEMS devices, please ref to the present manual, for other
complementary or alternative devices, please ref to the proper manuals and
documents.
- Walls, floors and ceilings adequate to insert of fixing parts, and strong
enough to handle the weight of the different structures installed.
All devices described in the present manual can be used in the following
environmental conditions:
Installation
When planning the position of ZETA (every model) in the room, consider that the
chest bucky must allow examination with film/focus distance of 180÷200 cm (X-
ray examination of the thorax) and as well to a film/focus distance of 100÷120
cm.
Holes
DTR SIDE
WALL SIDE
Tuning from
88 to 112 mm
- Film/patient skin: 40 mm
- Film/patient skin: depends on flat panel installed.
4. In the installation site, place the Chest Bucky to the wall it using the nylon
plug without fix it to the buttom: the telespopic plate could be tuned on the
orizonthal plane.
5. Add or remove some counterweight so that the detector, with the brake
unlocked, move up. The entire procedure in described in the section
“Counterweight”.
6. With the collimator beam, perform the centring of the detector of Chest
Bucky with the X-Ray source. Is advisable to perform this operation for the
following 3 S.I.D.:
a. 100 cm
b. 150 cm
c. 200 cm
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7. At the end of the centring procedure, fix the Chest Bucky to the floor and to
the wall using the given plug (wall=nylon plug, floor=steel plug). Use the
holes in the following picture:
b. Join the base using the 4 M12 exagonal head screws given in the
installation kit, to the 4 holes showed in the following picture:
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COLUMN
BASE
2. Place the ZETA in vertical position and move it to the installation site.
3. Add or remove some counterweight so that the detector, with the brake
unlocked, move up. The entire procedure in described in the section
“Counterweight”.
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b. Floor fixation:
• Counterweight
Procedure.
1. Remove the backside cover near the base of the ZETA.
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2. Insert some counterweight, sliding them parallel to the tray and pushing
them till the and of the tray.
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4. Using the “counterweight lock plug” to lock the counterweight to the tray.
5. Unbrake the detector and ensure that it move up SLIGHTLY.
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The Chest Bucky ZETA could be connected with the following accessories:
Installation
a. Push the handle (1) and apply the PCM900 to Chest Bucky as descrive
in the picture below.
b. Release the handle (1) to lock the cassette tray.
c. Release the knob (2).
d. Insert the cassette and set the jaws (3) to lock the cassette.
e. Screw the knob (2) to lock the entire system.
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2
1
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Installation
a. Insert the handle to right or left side in the holes placed in the upper
side of the Chest Bucky.
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Installation
a. Remove the screws marked in the picture below.
b. Remove the upper cover of the detector and replace it with one with the
lateral holes.
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Rear handle
Device designed to aim the patient during the exam in orthostatic position placed
with shoulder facing the X-Ray beam. This accessories is installed in factory.
Installation
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The user is required of a few cleaning and ordinary maintenance operations, and
a few visual check of some moving part. These simple operations are anyway
highly important for a safe use and a long life cycle of the devices.
All controls and maintenance operation which requires the access to the internal
parts of the devices, as well as some ordinary and extraordinary maintenance
operations are exclusive duty of authorized personnel.
In the following table we report all common cleaning operation and visual check
recommended for a correct use of the devices.
Frequency Operation
Check the correct work of all light signals and the correct
Daily readability of all labels and indications placed on the
structures.
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In following table are listed all recommended operations for periodically ordinary
maintenance:
Frequency Operations
Unlock the brake and move the detector right/left and check the fluidity and
the noiseness.
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NOTE 1
Italicized parts and codes are not available as spare parts; in cases where these part and codes
will show defect and malfunction not fixable on site, the whole device will be retired and
completely exchanged with a new one.
NOTE 2
For Potter Bucky and Digital Pack spare parts, please refer to the relative manuals.
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Pic.13-1
Every unit could be shipped dismantled in 2 pieces (base and tabletop) in the
same package, every component is labelled with S/N placed on:
• Package
• Single part
This care avoids exchanging the single components with ones from other table of
the same model.
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XIII – Disposal
This medical device must be managed in full respect of Article 13 of Dlg July 25,
2005, Nr 151 ’’Attuazione delle direttive 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 symbol with the crossed garbage bin indicate that the product, at the end of
its shelf life must be collected in separated way from the other garbage.
The separate collection of this device must be arranged and managed and by the
manufacture.
The user that want to get rid off this device will contact the manufacture and
follow is protocol for the garbage disposal.
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XIV – Symbols
The Chest Bucky ZETA presents several symbols, that here follow with detailed
explanations. Users and technicians are carefully intended to be aware of the
meaning of each symbol and to respect them in every operation.
User and technician are forbidden to remove any of the signals present on the
device.
CE conformity mark
0051
Instruction.
WAEE Disposal
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Via Marzabotto, 21 / 23
20871 VIMERCATE (MB)
-ITALY-.
Tel. 039/6080443
Fax 039/6082557
Via E. Amaldi, 14
00015 Monterotondo (Roma)
Tel. 06 90670300
Fax 06 90670303
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XVII – CE Mark
ZETA is a medical device with CE mark achieve with support of a notified body
of the European Union.
0051
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