User Manual EN
User Manual EN
User Manual EN
Revision: E
Version: 26 October 2009
File: [201175-E-10-01.doc]
User’s Manual
WARNING: The information that is printed within this manual is vital for the correct use of the
equipment; please read it carefully before use.
User's Manual TECHNOS 5/3 Sias S.p.A.
[File:201175-E-00-01.doc]
Sias S.p.A. TECHNOS 5/3 User's Manual
Table of contents
This x-ray unit must be used in strict compliance with the safety
instructions contained in this manual and must not be used for purposes
other those for which it was intended.
The x-ray unit may only be operated by skilled, properly trained personnel with the required
knowledge of x-ray safety practices and the proper use of x-ray equipment.
The operator is responsible for the use of the system in compliance with the applicable
standards concerning installation and use.
The system safety circuits and devices must not, for any reason, be moved, modified, or
omitted.
The monitor trolley key switch may only be activated by authorized personnel and only
during the use of the system. Once system use has been completed, the key must be
removed and stored in a safe place.
The unit must not be operated when electrical, mechanical, or radiological faults are present
or when any of the indicators or alarm devices are malfunctioning.
As with any technical apparatus, this x-ray unit must be used properly with periodic checks
and maintenance as specified in the chapter “Planned maintenance” of the Service Manual.
Sias S.p.A. is responsible for the safety of its products only when maintenance, repairs, or
modifications have been performed by its personnel or by personnel authorized by Sias
S.p.A. in writing.
Sias S.p.A. cannot be held liable for any malfunction, damage, or danger
resulting from improper use of the system or non-compliance with the rules
for proper maintenance.
Only trained service personnel authorized by Sias S.p.A. may remove the
unit covers and only in accordance with the instructions contained in the
Service Manual.
This x-ray unit may only be used in environments or medical rooms in compliance with the
applicable IEC standards.
The x-ray unit must not be used in areas where there exists a danger of explosion.
Cleaning and disinfecting agents, including those used on patients, may create an explosive,
gaseous mixture. Use only those products in compliance with the applicable rules.
The only purpose of the laser use is to reduce the patient dose to a
minimum, it doesn’t be considered as an absolute means of centering.
The activation of procedures other those listed above can cause the
emission of dangerous non-ionizing radiations.
• Move the unit by considering the conditions for the movement that are indicated in detail
in the paragraph 3.1.
• Don't move and use the unit on surfaces with inclination higher than 5°
• Only use the proper handles to move the unit.
• Avoid collision with obstacles.
• After positioning the unit, engage the parking brakes.
It is not, however, possible to exclude radio signals coming from transmitters such as mobile
phones or similar mobile radio devices. These and other transmitting devices, including
those in compliance with the EMC standards, may influence the proper functioning of
medical apparatus when used in proximity and with a relatively high transmitting power.
Therefore, the use of radio equipment proximity to electronically controlled systems must be
avoided in order to eliminate any interference risk.
Before any x-ray exposure, ensure that all the necessary protective
precautions have been taken.
During the use of x-rays, personnel present in the room must comply with the following rules
concerning protection against ionizing radiation:
When necessary, use protective shielding against radiation in addition to the shielding
already provided on the unit.
Use protective aprons containing a material equivalent to 0,35mm of lead. Material of this
nature reduces radiation at 50kV by 99,95% and at 100kV by 94,5%.
The best protection against radiation is distance. It is therefore recommended that you stay
as far as possible from the x-ray source and the exposure target. For this purpose, use all of
the cable length provided for the foot-switch.
Avoid walking or standing directly in the x-ray beam.
Always use the smallest possible field of exposure by closing properly the collimator
diaphragms. The scatter dose produced depends principally on the volume of the irradiated
object.
For this reason, the unit may not be disposed of along with industrial or
domestic waste and must be regarded as hazardous waste.
This symbol indicates that the waste of electrical and electronic equipment must
not be disposed as unsorted municipal waste and must be collected separately.
The proper differentiated collection for the following start of the unit disused to the
recycle, treatment and disposal, compatible with the environment, aid to prevent
possible negative effects on the environment and health and it favours the recycle
of materials that compose the unit.
The abusive disposal of the product from the user implies the application of
administrative sanctions according to the Standards in force of the unit installation
country.
For information concerning the dismantling modes of the units out of use, stick to
the local provisions or contact a representative authorized by the manufacturer.
1.7. Interfaceability
The device does not forecast any interaction with devices for medication.
It is possible to interface the unit with certain devices such as DVD Recorder, thermal printer,
Network (DICOM System). Such devices must be in full compliance with the safety
requirements specified by 93/42/EEC Directive. The liability of the interface, if it has not been
evaluated and authorized by Sias S.p.A. in writing, is of the operator and/or of the person
who has performed this interface.
1.8. Copyright
The original release of this manual is in Italian language (file: 201175-X-00-00.doc). For
further information, please refer to the Italian version.
The software contained in the unit belongs to Sias S.p.A.. Upon receipt of the unit, the user
acquires the right to use the software. This right is neither exclusive nor transferable.
Written authorization to Technix S.p.A. is mandatory prior to any modifications for the unit
use with functions other than the ones foreseen.
The system does not belong to the category of equipment designed for continuous
operation.
The system is not used in contact with the patient; however, accidental contact of
some unit parts with the patient and the operator is possible.
Contact with the operator is strictly for reasons linked to the use of the equipment
(normal operation).
The unit is suitable to be used for x-ray examinations, and in particular for radioscopy,
radiography and diagnosis dedicated to:
• Traumatology
• Pediatrics
• Simple interventional radiology
• Pace Maker implantation
• Operating theater
• Intensive care
• Respiratory system
• Skeletal structure
This x-ray unit must not be used in areas where danger of explosion
exists.
For use in operating theater, it is necessary to use a sterile coverings to
protect the arm-monobloc-intensifier group from liquids seepage and a
footswitch type IP-X8 (like the standard one).
The patient support must not have an equivalent filtration higher than
2mmAl.
The patient must be placed as close as possible to the image intensifier.
1.10. Classification
Protection against electrical hazards ................ Class I
Protection against direct and indirect contact ... Unit Type B with Type B applied part
Protection against water penetration................. Common protection (IPXO)
Fluoroscopy footswitch protected against the
submersion effects (IPX8)
Use condition protection.................................... Continuous working with temporary load
1.11. List of the Standards for the evaluation of the product compliance
Reference Description
MDD 93/42/EEC class IIB according to Medical Devices Directive (EC mark)
Annex IX rule 10.
IEC 60601-1 1st edition Medical devices safety
IEC 60601-1-2 1st edition Electromagnetic compatibility
IEC 60601-1-3 1st edition Protection against ionizing radiation
IEC 60601-2-7 2nd edition HV generators
IEC 60601-2-28 1st edition Tube-housing groups
IEC 60601-2-32 1st edition Mechanical safety aspects
ISO 14971:2000 Risk analysis
CEI EN 60825-1 2nd edition Laser equipment safety
TECHNOS 5/3 with radio-protection according to the Standard CEI EN 60601-1-3 (1995)
Inverter-monobloc group
(IN-9040-5 HF + I-40S 3,5 RF, IN-9040-5 HF + I-40R 5 RF) EN60601-2-7:1998
1.12. Compliance
For any further information concerning the The manufacturer (according to the European
compliance please contact: Directive 93/42/EEC) of the unit TECHNOS 5/3
is:
SIAS S.p.A. Sias S.p.A.
Via MInghetti, 9/11 Via E. Fermi, 45
40057 Cadriano di Granarolo dell’Emilia, BO 24050 Grassobbio, BG (ITALY)
(ITALY) Tel: +39 (0)35-3846611
tel. +39 051 60 20 211 Fax: +39 (0)35-335675
fax. +39 051 60 20 218
Web: http:www.sias-spa.it
E-mail: [email protected]
2. COMPONENT IDENTIFICATION
2.1. Overview
The unit TECHNOS 5/3 is made up of two different parts: Mobile Stand and Display Station.
Mobile stand consisting of:
“C” Arm, Monobloc, Image
Intensifier, Control Panel (Fig. 1).
Fig. 1
Fig. 2
Image intensifier
Control panel
Monobloc
Focus position
Fig. 6
Cable reel
ON key
Mains cable
Fig. 7
The brake handle is take-up type. In order to avoid 1. Brake for the arm
collision dangers with the unit or the user, always put the rotation around the
handle again in horizontal position. horizontal axis.
Movement:±270°
1
3. Brake for the orbital arm
3 rotation.
4 Movement:123°
2 (+90°÷-33°)
Fig. 9
Pos.1: brake ON
2 4
2.3. Keyboard
2.3.1. Unit
All keys are membrane type. The keyboard group can rotate ±45° in respect of the central position
for its simpler use.
Fig. 10
Area 1
Movimentazione verticale Spegnimento / Accensione
dell’arco centratore laser
Accensione
Segnalazione allarmi
dell'apparecchiatura
Area 2
Rotazione digitale Rotazione diaframma a
1
dell’immagine lamelle
Chiusura / Apertura
Ingrandimento immagine
diaframma a lamelle
Commutazione tra
Scorrimento immagini
immagine LIVE e immagine
memorizzate
MEM su singolo monitor.
Trasferimento immagine da
monitor lavoro a monitor
memoria
Decremento / Incremento
Decremento / Incremento kV
mA/mAs
1
Per memorie serie SBFM78, DIP e HRC: premendo contemporaneamente i due pulsanti di rotazione per
quattro secondi, si ha l’azzeramento della rotazione digitale dell’immagine
Pag. 12/76 - Rev. A [File:201175-E-00-01.doc]
Sias S.p.A. TECHNOS 5/3 User's Manual
The memories series SBFM78 have only the alphanumeric keyboard for the patient data input. The
keyboard can be placed under the unit keyboard (unit with monitor aboard) or on the highest shelf
of the “Base Trolley” in “Low Profile” configuration.
The memories series HRC have the alphanumeric keyboard and mouse for the patient data input.
Keyboard and mouse are placed on the highest shelf of the “Base Trolley” in “High Profile”
configuration.
On the High Configuration trolleys, there is always a small remote keyboard that duplicates some
controls present on the unit keyboard.
All keys are membrane type.
Fig. 11
1^ line 2^ line
Shutters diaphragm
Shutters diaphragm rotation
closing/opening
Iris diaphragm
n.a.
closing/opening
The memories series DIP have a keyboard dedicated to the post processing.
All keys are membrane type.
KEYBOARD ACQUISITION
~ ! @ # $ % ^ & * ( ) _ + M
` 1 2 3 4 5 6 7 8 9 0 = = L
Q W E R T Y U I O P { } ANGIOGRAPHY DICOM
[ ]
A S D F G H J K L : "
; '
Enter ON
Z X C V B N M < > ? ¦
, . I.R.
VIEW OVERVIEW
Fig. 12
For an easier understanding they have been divided into 7 different groups: KEYBOARD,
ACQUISITION, PROCESSING, ANGIOGRAPHY, DICOM, VIEW, OVERVIEW
KEYBOARD
Rotation + Rotation -
ACQUISITION
PROCESSING
It allows the images visualization in SHARP / SMOOTH / OFF edges
negative processing
ANGIOGRAPHY
Angiographic acquisition rate selection Key for the mode activation of the
1 image per second subtraction between images
DICOM
VIEW
OVERVIEW
The memories series HRP have the alphanumeric keyboard and the mouse for the patient data
input.
All keys are membrane type.
! @ # $ % &
* ( )
<
+ _
Num Scroll Print
` 1 2 3 4 5 6 7 8 9 0 =
{
-
} |
Lock
7
Lock
8
Pause
9
Screen
Q W E R T Y U I O P [ ] \ Home Pag *
: "
4 5 6
Caps-lock A S D F G H J K L ; '
Ent er -
> ? 1 2 3
Z X C V B N M , . / End Pag +
0 .
Ctrl Alt Alt Gr Ctrl Ins Del Ent er
2.3.4. Display
Note: the box with the dose indication is displayed only if the dosimeter is installed and in working
condition.
2
It is possible to deactivate the audible signals or modify the volume (§3.6.9 Utility Mode).
The fluoroscopy control footswitch consists of a double-step pedal and two single-step ones.
The functions in the different modes are:
Fluoroscopy Mode:
1° step: fluoroscopy control.
2° step: image storage; in continuous 3
fluoroscopy the current image is stored. 2
Fluoroscopy mode: 1
"snapshot" control (high-contrast
exposure with reduced background noise).
Fig. 13
Radiography mode:
1° step: preparation control.
2° step: emission control.
In radiography mode it is possible to press
immediately the exposure control (2° step),
with an emission delay due to the anode
starting phase (only for rotating anode version).
Unit “TECHNOS 5/3” with monitor aboard Unit “TECHNOS 5/3” + “Low Profile Base Trolley”
Unit “TECHNOS 5/3” + “High Profile Base Trolley” Unit “TECHNOS 5/3” + “High Configuration” trolley
1 8
2 7
5 6
1 Indication of the dose value (only if the dosimeter is present and in working condition /
MESSAGES and/or ERRORS Area)
2 Indication of the FLUOROSCOPY / RADIOGRAPHY phase.
3 Indication of the available thermal units (HUT), expressed in percentage from 0% (indicator
completely white and spent HUT) to 100% (indicator completely black and available HUT).
When the residual HUT value allows a use of the unit below five minutes, under the
indicator will appear also the residual time indication (t = …min), valued in function of the
employed power. Simultaneously it’s issued an acoustic alarm not modifiable.
When the residual HUT reach 0%, the x-rays emission block intervenes.
It’s possible to exceed this limit and proceed with the x-rays emission (only in fluoroscopy
mode) till intervention of monobloc thermal security.
This choice must be performed by Service personnel and on express request of the final
user.
As the monobloc temperature decreases, the HUT will be regenerated. Residual time
indication will disappear, when thermal units allow a use exceeding five minutes.
4 Selection of the Anatomic Curve in Fluoroscopy (Standard / Paediatric / Pelvis-Head /
Standard for sturdy patient (only for rotating anode with camera 1K2)).
5 Indication of the set kV value. It changes in Automatic mode or in Manual mode by using
the kV+ and kV- keys of the control panel.
6 Indication of mA value concerning kV and the selected curve. During the exposure it
indicates the measured mA value.
7 Indication of the AUTOMATIC / MANUAL mode.
8 Dose printing key. It appears if the dosimeter is present and in working condition and if the
printing mode in Utility Mode is selected (§3.6.9).
ALARM RESET
The dosimeter does not reply. Press the “ALARM RESET” key in
order to go on to work.
Check that it is not selected when
DOSIMETER NOT OK
it is not present on the unit.
Call Service to perform the
necessary checks.
At least eleven months are passed Press the “ALARM RESET” key in
from the last performed planned order to go on to work.
MAINTENANCE REQUIRED
maintenance. Call Service to perform the
planned maintenance.
Press the “ALARM RESET” key in
order to go on to work.
Warning! This function results
particularly important for the
REAL TIME CLOCK ERROR The system clock does not work.
calculation of the thermal units
recovery.
Call Service to perform the
necessary checks.
The thermal capacity of the Wait for the thermal units
EXHAUSTED THERMAL UNIT
monobloc is exhausted. recovery.
Continuous fluoroscopy time Release the footswitch and go on
EXHAUSTED XR TIME
exhausted (max 10min) with the operation.
Switch the unit OFF, wait for some
The generator does not seconds and switch ON again.
GENERATOR OFFLINE
communicate with the central unit. In case the error persists, call
Service.
Switch the unit OFF, wait for some
seconds and switch ON again.
CAN-BUS ERROR Error in the field bus
In case the error persists, call
Service.
Switch the unit OFF, wait for some
MEMORY CONTROLLER The memory does not seconds and switch ON again.
OFFLINE communicate with the central unit. In case the error persists, call
Service.
A removable operating key (pos. 3), that is necessary for the unit setup, prevents the unit
use from non-authorized personnel.
In case of “High Configuration” trolley, the magneto-thermic switch (pos. 1) and the safety
key (pos. 3) are not on the unit but on the trolley. Furthermore, on the “High Configuration”
trolley there is a mushroom-head emergency push-button that stops the power supply to the
whole unit (pos. 4).
3
2
4
Fig. 15
3. UNIT USE
3.1. Transport
Don’t move the unit on planes with inclination higher than 5°.
The unit must be moved only in the condition defined “of transport” (Fig. 16)
and with all the arm movement brakes on.
The uncontrolled arm movement could cause damages to the operator, patient
and personnel that are near the unit.
Before moving the unit, ensure that it is in safety position as shown in Fig. 16:
The sequence described below shows how to put the unit in safety position:
1. Overview position at 0°
2. arm rotation at 0°
Fig. 16
The unit must be OFF, the mains plug removed from the outlet and the cable winded-up on the
cable reel.
The monitor trolley must be disconnected from the Mobile Stand and the cables winded around the
reel.
• check that the arm movement brakes are all ON (locked) (see Fig. 8).
• don't move the unit on planes with inclination higher than 5°.
• move the unit only after unlocking the parking brake and use only the proper
handles (see Fig. 9 pos.3).
• in order to make the movement easier, use the rotation of the rear wheels of the mobile
image intensifier.
The connection between these parts of TECHNOS 5/3 is performed through a multipolar
connector with bayonet connection.
On “Base Trolleys”, the cable is fixed permanently from the monitor trolley side, whilst it is
sectionable from the unit side.
On “High Configuration” trolley, the cable is sectionable both from the unit side and the
trolley side.
Fig. 17
• insert the connector of the footswitch in the appropriate outlet present on the mobile
image intensifier (Fig. 18 pos. A);
Fig. 18
It is possible to use the unit as fixed position so that some warning signals are repeated outside the
operative room.
In detail the repeated warning signals are for:
• a lamp that indicates the unit ON
• a lamp that indicates the x-ray emission
• a door opening contact that stops the x-ray emission.
The connection is performed through a multipolar connector with locking on ring nut (Fig. 18 pos.
B). The prearrangement of the external signals wiring must be performed by the technical
personnel.
For a correct connection it is necessary to:
• ensure that the unit is OFF;
• remove the terminal board closing cap;
• insert the connector of “external interlocks” in the proper socket present on the mobile
image intensifier;
• ensure that the connector is screwed tight.
In order to remove the connection it is necessary:
• unscrew and remove the cable connector
• apply again the closing cap in the terminal board.
The unit TECHNOS 5/3 has got a switching-ON key with three car-type positions.
The unit TECHNOS 5/3 has got a switching-ON key with three car-type positions mounted
on the monitor trolley.
Connect the trolley to the mains and put the magneto-thermic switch in “I” position.
Insert the switching-ON key and turn it clockwise in “WAIT” position.
Turn the switching-ON key clockwise in “START” position and release it (the
switching-ON led will light up on the trolley control panel). The trolley is powered
and it can work even without the unit connected.
Connect the mobile image intensifier to the monitor trolley. The connecting cable
can be connected/disconnected even with the powered trolley.
Press the unit switching-ON push-button.
After the test phase of the internal circuits and the software, the display shows the
initial screen:
Activate the intended exposure mode according to what described in §3.6 “Use
mode”.
In order to turn the unit OFF, press OFF key, rotate the key in “OFF” position (on
the trolley), put the magneto-thermic switch in “0” position (on the trolley).
3.5. Positioning
Don't move the mobile image intensifier or the C-arm with brakes ON.
Use the control keys to change the position inside the travel.
Use the Down key with the “Down Enable” key to perform the extra-travel
downwards.
Adjust the C-arm rotation around the horizontal axis, the goniometric scale
will indicate the rotation angle (manual movement).
When the positioning has been completed, check that all the braking systems
are activated (see Fig. 8, Fig. 9).
If the display shows the “TUBE SEASONING” message, it means that the
unit is idle for three months or more and it is necessary to proceed with the
tube seasoning, in order to avoid high voltage discharges that could be
harmful for the x-ray tube.
This operation requires the intervention of a skilled technician.
Turn the unit ON according to what described in §3.4 “Unit ON / OFF”. After the
test phase of the internal circuits and the software, the unit is prearranged for the
working in automatic fluoroscopy. The display appears as showed below:
FILTER selection. By pressing the key, the selection and the indication aside
change (according to the installed memory).
STANDARD ANATOMICS curve selection. When the function is selected, aside the key,
the keys concerning the anatomic curves that can be selected appear.
ANATOMY curve for Fine Anatomic
Parts or paediatrics. When the key is selected, it appears
in “negative”. By selecting one of
ANATOMY curve for lungs. these curves, the unit proposes
proper kV-mA couples. It is not
ANATOMY curve for head, column, possible to modify the parameters.
pelvis for sturdy patient.
(1/2) mA curve selection. When the key is selected, the STANDARD curve with the
halved mA values is used.
Indication of the residual Fluoroscopy time and the relative resetting key.
The time indicates the effective x-ray passage and it is updated every second.
When 5 minutes are expired, the key is crossed and the audible indicator intervenes.
At any minute, it is possible to press the reset key by taking the time back to the initial 5
minutes and by stopping the audible signal, if it is in working condition.
After 10 minutes of continuous fluoroscopy, the x-ray emission is interrupted. This
supplementary time is resetting automatically at every release of the fluoroscopy
footswitch.
Key for the resetting of the dose value indicated in the central box. The key is active only
if the dosimeter is installed and in working condition.
Hold down for at least two seconds to reset the displayed value.
Press the left pedal of the x-ray control footswitch.
After activating the x-ray control, the kV/mA values can be adapted automatically to the
patient under examination in order to get the best possible image.
By pressing completely the pedal (second step), the image is stored.
X-ray emission LEDs on the keyboard and on the monitor trolley lit.
FILTER selection. By pressing the key, the selection and the indication aside
change (according to the installed memory).
Indication of the residual Fluoroscopy time and the relative resetting key.
The time indicates the effective x-ray passage and it is updated every second.
When 5 minutes are expired, the key is crossed and the audible indicator
intervenes.
At any minute, it is possible to press the reset key by taking the time back to the
initial 5 minutes and by stopping the audible signal, if it is in working condition.
After 10 minutes of continuous fluoroscopy, the x-ray emission is interrupted. This
supplementary time is resetting automatically at every release of the fluoroscopy
footswitch.
Key for the resetting of the dose value indicated in the central box. The key is
active only if the dosimeter is installed and in working condition.
Hold down for at least two seconds to reset the displayed value.
The same functions of Fluoroscopy, both Automatic and Manual, and Storage can
be performed also with the x-ray handswitch (if it is prearranged):
1° step: fluoroscopy control.
2° step: image storage.
In MANUAL mode, the kV and mAs value must be set by the operator. The
exposure parameters variation allows to modify the image quality at the discretion
of the operator.
X-ray emission LEDs on the keyboard and on the monitor trolley lit.
X-ray emission LEDs on the keyboard and on the monitor trolley lit.
3.6.5. RADIOGRAPHY
Put the cassette holder at the input of the I.I. tube by coupling the two fixed locks
and by locking the knob, insert the loaded x-ray cassette.
Set the kV and mAs parameters by operating on the relative increase and decrease
keys placed under the indication of the value selected on the display.
Use the whole length of the extensible cable to move away as much as
possible from the irradiated area.
Press the x-ray handswitch and hold it down till the end of the exposure.
X-ray emission LEDs on the keyboard and on the monitor trolley lit.
APR radiography
By selecting the wished APR program, the relative key appears in negative and, on
the right side of the screen, the keys concerning the selection of “slim patient” and
“sturdy patient” appear.
Key to select the APR values for slim patient (visible only if an APR program is
selected).
Key to select the APR values for sturdy patient (visible only if an APR program is
selected).
When the prearrangement for slim or sturdy patient is selected, the icon of the key
in “negative” appears.
The proposed data can be modified at pleasure
by the user. If the storage function is enabled in
the USER SETUP menu (§3.6.9), the modified
Data storage key values can be saved in memory through the
relative key. In case the modified data are not
stored, at next return in Radiography mode, the
default data will be re-proposed.
HiPower radiography
By selecting HiPower radiography, the relative key appears in negative, the keys
concerning the APR programs disappear and the mAs are limited to a value lower
than 4mAs. The kV can be set without limitations.
In this mode it is possible to perform a radiography at 5kW with rotating anode and
at 3,5kW with fixed anode.
Enlarge or reduce in size the irradiated area through the iris diaphragm
or the parallel shutters diaphragm.
For additional images processing, refer to the user’s manual of the memory installed on the unit.
In case of unit provided with DTU (Dicom Transmission Unit), it is possible to transfer the images to
a network printer or to a central file for the possible filing or processing. In this case it is necessary
to connect the unit to the network through a connecting cable (it is not supplied with the unit). The
DTU, RJ-45 plug for connector, is present only on the trolleys showed in the following figure.
For the operation of transfer or printing, refer to the DTU User’s Manual.
Page with the firmware parameters display, serial number and data
REPORT
for service (see next page).
ANNULLA Key to exit from UTILITY MODE without saving the modifications.
INC-DEC Keys to increase and decrease the value displayed on their left.
Don't disconnect the cable between the mobile image intensifier and the
monitor trolley if the mobile image intensifier is not off.
Don't remove the connector from the mains outlet if the unit is not off.
1. Position the mobile image intensifier in parking position (down, with the mechanical
brakes ON).
2. Turn the mobile image intensifier OFF by operating on the "unit off" key of the control
panel. Rotate the key in OFF position, remove and store it in a safe place.
3. Coil the footswitch cable and put it in the proper place.
4. Disconnect the mains cable and coil it again on the proper supports of the unit.
5. Disconnect the cable of the mobile image intensifier/monitor trolley and coil it on the
proper supports of the monitor trolley
(only for version with monitor trolley)
6. Park the monitor trolley by engaging the wheels brakes
(only for version with monitor trolley)
4. MAINTENANCE
4.1. General warnings
As with any technical device, this system requires:
o proper use;
o regular checks by the user;
o regular maintenance by the authorized personnel
By taking these precautions, the working and the operative reliability of the unit are ensured.
The user of a x-ray unit is obligated to adopt such precautions in compliance with the accident-
prevention standards, the standards on the medical products and other regulations.
The unit needs regular checks and maintenances. The purpose of the following warnings is
to keep a good operating and safety level.
The unit includes mechanical parts that are subjected to wear in function of the use. After a
long period of use, it is possible that the safety of the system may decrease due to the parts
wear.
Regular checks and maintenance are necessary to protect the patient and the operator from
damage due to the mechanical parts breakage.
The correct adjustment of the electro-mechanical and electronic modules is essential, as this
has a direct influence on the unit operation, the image quality, the electrical safety and the
exposure level of radiation to which the medical - nursering personnel is subjected.
The maintenance plan includes checks and prevention measures to be done by expressly
authorized personnel and at the unit owner's charge.
In the replacement of any parts that can affect the units safe operation, use
only original spare parts.
Inspection
Half-yearly Operation of the arm movement limit switch.
Accessories for the centering of the x-ray group and the image acquisition
unit (marks, lock devices, contacts).
Yearly Contact the technical after-sale service to perform the constancy and Inspection
reproducibility tests, as indicated by IEC 61223-1 and IEC 61223-2-11
standards, as well as the other operating tests of the unit, as instructed in the
planned maintenance plan.
4.3. Cleaning
Please take the following information into consideration before choosing a detergent:
• To clean plastic surfaces, simply use water and soap. If other detergents are used (e.g. with a
high alcoholic content), the material will tend to break or opacify.
• Never use corrosive substances, abrasive solvents or detergents.
• To clean enameled and aluminium surfaces, simply rub them with a wet cloth and a delicate
detergent, after that rub them with a dry wool cloth.
• To clean chromium-plated surfaces, only rub them using dry wool clothes.
Do not use direct water jets or detergent for cleaning. The unit protection level
for liquids is IPXO.
4.4. Disinfection
The used disinfection method must be in compliance with the standards and the directives in force
concerning the disinfection and protection against explosions.
5. TECHNICAL DATA
5.1. Labels and symbols
2
1
Fig. 19
2
2 1
1
Fig. 20
Fig. 21
Fig. 22
Codes present on the label in relation to the installed I.I. tube type:
X-RAY GRID
Focus: 80 cm
Ratio 8:1 36 L/cm
MAIN label
Equipotential node
Brakes lock/release
WHEEE label
label.
Monitor connection
External connections (only version with monitor
aboard)
Hands squashing
Footswitch
hazard
Image contrast
Image brightness
on/off push
Fluoroscopy control +
Image storage
SNAPSHOT Control
The values indicated in the graph refer to the trends calculated from the software safety procedures that
are preventive concerning the bimetallic contact inside the monobloc that indicates the achievement of
57°C (134,60°F).
The values indicated in the graph refer to the trends calculated from the software safety procedures that
are preventive concerning the bimetallic contact inside the monobloc that indicates the achievement of
57°C (134,60°F).
5.3.2. COLLIMATOR
Description Data
In case it is not used for more than three months, proceed to the tube reset in the following way:
If during the procedure some working irregularities or anomalies are found, it is necessary to stop it
for at least half an hour and start it again from the beginning.
dimensions
Monobloc I-40R 5 RF
dimensions
Rotating Anode
Description Fixed Anode Version
Version
Half-value layer @75kV 2,8mmAl 2,8 mmAl
Half-value layer @110kV - -
Half-value layer @120kV - -
Camera 0,5K2
Description Fixed Anode Version Rotating Anode Version
Camera 1K2
Description Fixed Anode Version Rotating Anode Version
0,5K2 Camera
Description Fixed Anode Version Rotating Anode Version
1K2 Camera
Description Fixed Anode Version Rotating Anode Version
Camera 1K2
Description Norm
Brand Thales
Model TH 9428 HP2
H542 VR13
Fields Number 3
Nominal Input Diameter 230 mm
Output Image Diameter 20 mm
Output Window Thickness 3,6 mm
Useful Input Field Size 215/160/120 mm
Typical Resolution (Central) 48/56/64 lp/cm
Conversion Factor (Cd/m-2/mR/s-1) 240/120/60
Contrast Ratio 23:1/25:1/30:1
Integral Image Distortion 4% / 2% / 1%
Differential Distortion at 90% radius 15% / 6% / 3%
DQE at 59.5 kV 65%
"All metal" Technology Yes
Input Screen "Hi-Res." Yes
MTF at 10 Lp/cm 60/65/70%
MTF at 20 Lp/cm 25/30/40%
Low frequency drop LDF 7/6/5%
Fixed Antiscattering Grid Ratio 8:1, 36 shutters/cm,
focus 80 cm, material
aluminum
Description Data
Camera
Camera technology CCD at low persistence of ½” (470.000pixels)
Video standard CCIR 625/50Hz interlaced with matrix 752x 582 pixels
Aspect ratio 4:3 interlaced scanning
Band width 20 MHz ± 3dB
Signal-noise ratio 65 dB
Resolution 20 lines-pairs (on 6” image intensifier)
Gamma correction 0,4 o 1
Automatic video level Yes
compensation
Dynamic contrast Shading Yes
Video output A/D converter 10 bit
Power supply 24Vdc ±20% 20W
Control Unit Dimensions 226x120x46 mm, 0,550Kg
Camera Head Dimensions Ø85x87mm, standard
Camera Head Weight 0.460Kg, standard
Description Data
Camera
Camera technology CCD interlain progressive scanning
Active pixels 1024x1024
Acquisition Matrix 1024x1024 pixel, 10bit, rate 25fps
Resolution contrast 1024 grey levels
Sensitivity 0,2 LUX (PB20 light)
Noise signal ratio 60db
Weight (board + optics) 1400gr
Camera head power supply 24Vdc 200mA
Receiver power supply 12Vdc 400ma
Monitors
Features DIP3000 A
Number of monitors 2
Flicker free YES
Smart Filter, motion detector YES
algorithms
Virtual shutter YES
Frame acquisition rate YES, 1,3,6 fps
Recursive Filter, YES 2,4,8,16
Noise reduction, OFF,2,4,8,16
Left and Right image inversion YES
Real time Digital rotation without X- YES
Ray on memory
Cine loop review YES
Programmable frame rate acquisition Yes, 1, 3, 6 fps
Zoom YES, by 2
Overview YES, 4/16 images
Contrast enhancement YES
Edge enhancement YES
Smooth, Normal, Sharp in real time
Digital adjustment for YES
contrast/brightness
Positive/negative image display YES
Text editing YES
Overlay note YES
Post Processing
Image horizontal and vertical inversion Yes
Brightness and contrast Yes
Grey scale inversion Yes
Edges enh Yes
Cineloop Yes
Electronic collimator (rectangular and circular) Yes
Shifting pixels Yes
Electronic zoom factor from 1,2 to 3 Yes
Electronic lens factor from 1,2 to 3 Yes
Images sum for noise reduction Yes
Images composition for research of the max. contrast Yes
liquid concentration
Land marking Yes
Overview 4-9-16 images Yes
Image subtraction Yes
Measures
Distances calculation Yes
Angles Yes
Stenosis Yes
Text overwriting Yes
Dicom options
Dicom VERIFY (SCU/SCP)
Dicom STORAGE (SCU)
Dicom WORK LIST (SCU)
Dicom PRINT (SCU)
Dicom CDR/DVD
Dicom QUERY/RETRIEVE (SCU)
Dicom MPPS (CPU)
Dicom STORAGE COMMITMENT (SCU)
Description Data
Network connection features: ESIDIC2, ESIDIC3
Speed Ethernet autosense 10/100 M bit/s
Protocol TCP/IP
IP address Personalizable in 4 byte
IP mask Personalizable in 4 byte
Dicom connection features, Functions performed:
Dicom VERIFY (scu/scp) Supported
Dicom STORAGE (SCU) Supported
Dicom WORKLIST (SCU) Supported
Dicom PRINT (SCU) Supported
Dicom CDR/DVD (media Interchange) Supported
Dicom MPPS (SCU) Not available
Dicom STORAGE COMMITMENT (SCU) Not available
Dicom QUERY/RETRIEVE (SCU) Not available for ESIDIC 2.
Available for ESIDIC 3.
Dicom port address Settable
Video Output on live LCD monitor High resolution 1249/50 Hz, 1049 60 Hz
Video output VGA, 1280/1024 60 Hz
Hard disk 80 GB or more
DICOM Terminology
Terminology Description
Dicom VERIFY (SCU/SCP) It allows the connection check, in both ways, with
Dicom units present on the network.
Dicom STORAGE (SCU) It allows to send the images to a Dicom server for
filing.
Dicom WORKLIST (SCU) It queries and receives from a Dicom server the
patients list to be examined on the acquirement
system.
Dicom PRINT (SCU) It sends to Dicom printer the images to be printed in
panoramic way and through film composer.
Dicom CDR/DVD (media Interchange) It burn on Cd or DVD the patients images with the
possibility to add a display program.
Dicom MPPS-Modality Performed Procedure Step It informs the server that the examination is in
(SCU) operation and then that it has been completed by
sending the reference indication to the images and, if
available, the total acquirement dose.
Dicom STORAGE COMMITMENT (SCU) It asks and wait for the confirmation to the storage
server that the images sent are saved in a safe way
by allowing the cancellation of the acquirement unit
from the file.
Dicom QUERY/RETRIEVE (SCU) It queries and receives from a server the images of a
patient data for consultation.
SCU (SERVICE CLASS UNIT), unit that asks a Dicom service to a unit SCP (SERVICE CLASS PROVIDER)
that is able to supply such service.
5.8. Accessories
Description Data
Wave length 635nm
Optical power of the laser diode < 4 mW
Optical power of the collimated beam < 3,5 mW
Divergence 6,67 mRad
Optical power on the operation plane < 3 mW
Safety class 1A
Description Data
Measurement amplifier
Measurement category Dose area product
2
Measuring unit μGy m
2
Digital resolution 0,01 μGy m
Measurement category
Measurement category Dose area product rate
2
Measuring unit μGy m /s
2
Digital resolution 0,01 μGy m /s
Nominal useful range
Dose rate range 0,10 to 400 mGy/sec
Max field dimension φ 6 cm
Min field dimension φ 0,6 cm
2
Dose area product range rate 0,01 to 4500 μGy m /s
Tube voltage 40 to 120 kV
Chamber: Type TA34037
Dimension of chamber field φ 7,2 cm
Max energy dependence ± 8% according to IEC60580, Table 6
Hardening equivalent value < 0,3 mmAl / 70 kV according to IEC60522/1999
Description Data
Print method Thermal printer with multi image picture ( UP 960 only 2 images )
Sublimation print, not available
Thermal head 1280 elements
Grey levels 256 levels
Sheet format Amplitude from 210 mm
Print dimensions UP990CE Standard mode CCIR 187 x 138 mm ; EIA 187 x 140 mm
Side mode CCIR 186 x 249 mm ; EIA 188 x 249 mm
Print dimensions UP970CE Standard mode CCIR 190 x 142 mm ; EIA 190 x 144 mm
Side mode CCIR 181 x 243 mm ; EIA 184 x 243 mm
Printer memory UP960CE 2048 x 1024 x 8 bit; UP980CE 2048 x 2048 x 8 bit:
Printer time Standard CCIR about 12 sec.; Standard EIA about 10 sec.
Inputs to the printer CCIR or EIA videocomposed BNC 1.0 Vpp, 75 ohm high imped
Output from printer CCIR or EIA videocomposed BNC 1.0 Vpp, 75 ohm high imped
Power supply 120 ÷ 240V 50 / 60 Hz
Size 316L x 132H x 305D mm
Weight 8 Kg
Paper Thermal paper, dry blue film only for UP 980
Accessories Remote control
Description Data
General data:
Recording System DVD recording, NTSC/PAL, Switchable
Recording Format Video: MPEG-2 compression
Audio: Dolby Digital Format
Recordable media DVD+RW ( 2,4x and 4x speed )
Recording time HQ mode: 60 minutes
SP mode 120 minutes
LP mode 180 minutes
Medical Standards EN60601-1, EN60601-1-2, UL60601-1,CSAC22.2 N° 60601-1
Power Requirements From 100 to 240 Vac 50/60 Hz
Power Consumption 35 W
Operating temperature +5° to +40° C
Storage temperature -20° to +60° C
Operating Humidity From 20 to 80 %
Size 212 x 128,5 x 382 cm
Mass 6 Kg
Input / Output
Analog Composite Input BNCx2, with loop-through, unbalanced 1.0 Vpp 75 Ohm
S-Video Input 4 pin DIN x2, with loop- through
Y: 1Vpp, 75 Ohm unbalanced
C: 0,286 Vpp ( NTSC)/ 0,3 Vpp (PAL), 75 Ohm, unbalanced
Analog Composite Output BNC x1, 1±0,2 Vpp, 75 Ohm, unbalanced
S Video Output 4 pin DIN x1
Y: 1Vpp, 75 Ohm unbalanced
C: 0,286 Vpp ( NTSC)/ 0,3 Vpp (PAL), 75 Ohm, unbalanced
Analog Audio Input RCA Pin x2 /L/R), 2 Vrms /full bit), input impedance 47 kOhm
Analog Audio Output RCA Pin x2 /L/R), 2 Vrms /full bit), load impedance 47 kOhm
Monitor Audio Output Monitor RCA Pin x1 /L/R), 2 Vrms /full bit), load impedance 47 kOhm
ILINK (DV IN) ILINK 6-pin x1 IEEE1394
Remote Control RS-232C x1 D-sub 9-pin
USB 2.2 x1 (Full Speed )
Remote 2 x1, stereo mini jack for connection with optional FS-20 foot
switch
Description Data
Model MediCap USB200. Digital medical Image capture device.
Saves digital images and video sources to a USB flash drive or USB
hard drive.
Equipped with USB Data: 2GB, 350 Kb per image, about 5700 image
Case Rugged metal case with high-impact plastic faceplate
Buttons Sealed membrane, fluid resistant
Video PAL / NTSC (switch selectable)
S-video or composite BNC connections for both input and output
Foot Switch Hands-free capture. Standard 3.5 mini jack
Mechanical Size: 240 x 200 x 63mm / 9.5 x 9.7 x 2.5” Weight: 1.7 Kg / 3lb
Environmental Storage: -40° to +85° C - Operating: -20°n to +40° C
Power 100/240Vac 50-60Hz 20W 3-prong AC jack
Media USB flash drives (MediCapture brand recommended) or external USB
hard drive
Image Formats DICOM, JPEG, TIFF, PNG
Video Formats MPEG2 PS, DVD-quality. Quality Levels:
Low (DVD-): 352 x 240 pixels, 1.5 Mbps Variable Bit Rate (VBR)
Normal (DVD): NTSC: 720 x 480 pixels, 3.5 Mbps VBR
PAL: 720 x 576 pixels, 3.5 Mbps VBR
High (DVD+): NTSC: 720 x 480 pixels, 8 Mbps VBR
PAL: 720 x 576 pixels, 8 Mbps VBR
Audio format MPEG1 L2, 2 channels, 16 bits/channel, 48 kHz sampling 256 kbps
bitrate
Image Size 1024 x 768 pixels, 800 x 600 pixels, 640 x 480 pixels
Certifications IEC, UL, CSA, FCC
6. MECHANICAL DATA
6.1. C-arm unit dimensions with I.I. 9”
300 [11,81
Interventionist
reference point
Reference axis
max.
admissible
weights on the
single shelves:
2 kg.
10 kg.
In the version
“Low Profile
Base Trolley” for
systems 0,5K2,
the two lower
shelves are not
available.
(A) Vertical motion Total travel 500 mm (19,69 in) , motorized in 60 sec
The measures are referred to the figure at page 73 (§6.1 -C-arm unit dimensions with I.I. 9”)
7. DOCUMENT STATUS
Rev. Date Page/s Modification description
- 30/10/2007 - Document approval
A 28/04/08 All General document revision.
6, Note addition on the unit versions.
10, 11, Note addition about the use of the overview movement handle.
21 “Error of the field bus” alarm addition.
B 28/11/08 25, Note addition about the unit-trolley connection cable insertion.
36, Added automatic opening of the collimator diaphragms.
38, Modified “User Setup” page.
46, 47 Added warning label.
Unification of the SNAPSHOT function wordings, added data of
14,18, 20, HiRad exposure time range, modification to the small focus from 0,6
C 06/04/09 44,47,48,54,5 to 0,5 on the OX/100-5 insert concerning the fixed anode monobloc
7,58,60,61 and various corrections in the document. Updated description at
point 3 of the “Operative Messages”
7, 44, 48,
Introduced the new model of fixed anode monobloc and inverter.
D 10/09/09 52, 53.
Added DICOM function, new Medicap USB200 model.
68, 69, 70, 72
Introduced the new model of rotating anode monobloc and inverter.
7, 43, 44, 47,
Upgrading of manufacturer address and relative S/N labels
E 26/10/09 52, 54, 55, 61,
Upgrading of data table HRP HRC DICOM and laser targeting device
67, 68, 69, 70
data.
F