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TECHNIX

Revision: 8
Version: 26 October 2009
File: [AD3001_E00R08.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 - TMS300 Technix S.p.A.

(This page is intentionally left blank)

[File: AD3001_E00.doc]
Technix S.p.A. TMS300 - User's Manual

TABLE OF CONTENTS

1. SAFETY AND COMPLIANCE........................................................................................................ 2


1.1. Electrical safety .................................................................................................................... 2
1.2. Mechanical safety ................................................................................................................ 2
1.3. Electromagnetic compatibility (EMC) ...................................................................................... 3
1.4. Protection against ionizing radiation ...................................................................................... 3
1.5. General disposal.................................................................................................................. 4
1.6. Application & final destination............................................................................................... 4
1.7. Interfaceability ..................................................................................................................... 5
1.8. Classification ....................................................................................................................... 5
1.9. Compliance......................................................................................................................... 5
1.10. Copyright............................................................................................................................ 5
2. COMPONENT IDENTIFICATION................................................................................................. 6
2.1. Overview............................................................................................................................. 6
2.2. Collimator ........................................................................................................................... 6
2.3. Control panel ...................................................................................................................... 7
2.4. Audible signals..................................................................................................................... 8
2.5. Signals and error messages................................................................................................... 9
3. MESSAGES ON THE DISPLAY.................................................................................................... 10
4. FUNCTIONING ....................................................................................................................... 12
4.1. Transport........................................................................................................................... 12
4.2. Positioning......................................................................................................................... 13
4.3. Collimator adjustment ........................................................................................................ 14
4.4. Start up and checks at the ignition ....................................................................................... 15
4.5. Exposures .......................................................................................................................... 16
4.5.1. Operative procedure ........................................................................................................ 16
4.5.2. Programs for the Anatomical programming mode (APR MODE)........................................... 17
4.5.3. Perform an exposure......................................................................................................... 18
4.5.4. Useful information ............................................................................................................ 19
4.5.5. Optional: dosimeter (DAPmeter)........................................................................................ 19
4.5.6. Optional: Radiography with examination table and Potter Bucky grid ................................... 20
4.6. Shutdown procedure .......................................................................................................... 20
5. MAINTENANCE ....................................................................................................................... 21
5.1. General Warnings.............................................................................................................. 21
5.2. Checks and inspection by the user ....................................................................................... 21
5.3. Cleaning ........................................................................................................................... 22
5.4. Disinfection........................................................................................................................ 22
6. TECHNICAL DATA.................................................................................................................... 23
6.1. Electrical data .................................................................................................................... 23
6.2. Functioning features ........................................................................................................... 23
6.3. Radiological data............................................................................................................... 24
6.4. Environmental data ............................................................................................................ 25
6.5. Mechanical data ................................................................................................................ 25
6.5.1. Unit sizes.......................................................................................................................... 26
6.6. Components specifications.................................................................................................. 27
6.6.1. Generator ........................................................................................................................ 27
6.6.2. Tube-Housing Assembly .................................................................................................... 28
6.6.3. Collimator ........................................................................................................................ 30
6.6.4. DAP meter (dose-area product meter) (optional)................................................................. 30
6.6.5. Printer for DAP (optional)................................................................................................... 30
6.7. Accessories and options...................................................................................................... 31
6.8. Compliance with Directives and Technical Standards ............................................................ 31
6.9. Labels and symbols ............................................................................................................ 31
6.9.1. Internal symbols................................................................................................................ 33
6.9.2. Various symbols................................................................................................................ 33
6.9.3. Packing label.................................................................................................................... 33
DOCUMENT STATUS........................................................................................................................... I

[File: AD3001_E00.doc] Rev.4 - Pag. 1/34


User's Manual - TMS300 Technix S.p.A.

1. SAFETY AND COMPLIANCE


The purpose of this user's manual is to provide a set of easy to use instructions for the proper use of the
system. All of the information contained herein is based on the current version of the system. Technix S.p.A.
reserves the right to improve and implement changes to the information herein to reflect any changes
necessitated by technological enhancements to the system.

• 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 unit must not be operated when electrical, mechanical, or radiological faults are present
or when any of the indicators or alarm devices are malfunctioning.
• When used in conjunction with other apparatus, components, or modules, whose
compatibility is uncertain, it is necessary to ensure the absence of any danger to the patient
or operator. Consult Technix S.p.A. for information.
• Technix S.p.A. is responsible for the safety of its products only when maintenance, repairs, or
modifications have been performed by Technix S.p.A. or by personnel authorized by Technix
S.p.A. in writing.
• As with any technical apparatus, this x-ray unit must be used properly with periodic checks
and maintenance as specified in the chapter “Programmed maintenance”.
• The system safety circuits and devices must not, for any reason, be moved, modified, or
omitted.

Technix 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.

1.1. Electrical safety


• Only trained service personnel authorized by Technix 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.

1.2. Mechanical safety


• After positioning the unit, engage the parking brakes.
• Only use the proper handles to move the unit.
• Avoid collision with obstacles.

Pag. 2/34- Rev.4 [File: AD3001_E00.doc]


Technix S.p.A. TMS300 - User's Manual

1.3. Electromagnetic compatibility (EMC)


This apparatus is in compliance with the applicable rule regarding EMC, Directive 89/336, that defines the
max. allowed emission levels from electronic devices and the required immunity from interference caused by
externally generated electromagnetic fields

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.

Explanation:
The electronic apparatus that meets the EMC standards has been designed so that, under normal conditions,
any malfunctioning risk, caused by electromagnetic interferences, is avoided.
However, if radio signals coming from high frequency transmitters with a relatively high transmitting power are
used near the electronic apparatus, the risk of electromagnetic incompatibility cannot be completely
controlled.

Any transmissions by mobile radio equipment must be avoided.


Mobile phones must be switched off in zones close to the unit.
These rules must be applied when the unit is switched on (that is to say connected to the mains
and ready for use).

1.4. Protection against ionizing radiation

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.

Never modify or disconnect the safety circuits or devices designed to prevent accidental
exposures.

[File: AD3001_E00.doc] Rev.4 - Pag. 3/34


User's Manual - TMS300 Technix S.p.A.

1.5. General disposal


Technix S.p.A. produces radiological systems that are advanced in terms of safety and environmental
protection. Assuming that the unit is properly used, there is no risk to people or the environment.
In order to comply with applicable safety requirements, it is necessary to use materials that may be harmful to
the environment (for example: monobloc oil, protective lead, boards and electronic components). Therefore,
where necessary, proper disposal methods, according to the regulations of the country where the unit is
installed, should be followed.

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 wastes resulting from the electric and electronic units have not to
be disposed as undifferentiated town wastes and they have to be picked up 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 an representative authorized by the manufacturer.

For additional information, contact Technix S.p.A.

1.6. Application & final destination


This unit is a portable x-ray system aimed to fulfil a wide range of clinical applications; it must be operated
exclusively by qualified, trained personnel who have been informed of the risks linked to the use of ionizing
radiation.

The compactness and maneuverability of the unit enables the operator to navigate through obstacles such as
doors, small rooms, narrow aisles and lifts with ease and allows accurate positioning between patient beds.
The ergonomic design of the unit allows the operator excellent visibility during operation and movement.

The perfectly balanced monobloc arm allows free movement and positioning even in the more awkward
positions. The shape of the base allows easy positioning and handling under the patient beds. The position
and shape of the four antistatic wheels make the system easy to move even on coarse surfaces.

The system does not belong to the category of equipment designed for continuous operation.

The system is not used in direct contact with the patient; however, accidental contact of some unit parts with
the patient and operator is possible.

Contact with the patient is non-invasive.

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 diagnosis dedicated to:
• Operating theater
• Sport medicine
• Plaster room
• First aid
• Pediatrics
• Orthopaedics

This x-ray unit must not be used in areas where danger of explosion exists.

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Technix S.p.A. TMS300 - User's Manual

1.7. Interfaceability
The device does not foresee any interaction with medicines; instead it's possible to apply to the unit the
ionization chamber dosimeter as optional (mod. DIAMENTOR PX). It complies with the safety requirements
foreseen by the 93/42/EEC Directive. However, the liability of the interface, if it has not been evaluated and
authorized by Technix S.p.A. in writing, is of the operator and/or the person who has performed the interface.

1.8. 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)
Use condition protection................................... … Continuous use with intermittent load

1.9. Compliance

This x-ray unit is in compliance with the electromedical devices Directive 93/42 EEC and with the other
national and international standards in force.

Information concerning the compliance can be required to Technix S.p.A.

The manufacturer (according to the European Directive 93/42/EEC) of the unit TMS300 is:

Technix S.p.A.
Via E. Fermi, 45
24050 Grassobbio, BG - ITALY
Tel: +39 035 38 466 11
Fax: +39 035 33 56 75

1.10. Copyright
The original release of this manual is in Italian language (file: AD3001_E00RXX.doc). For further information,
please refer to the Italian version.
The software contained in the unit belongs to Technix S.p.A. Upon receipt of the unit, the user acquires the
right to use the software in combination with the unit. 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.

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User's Manual - TMS300 Technix S.p.A.

2. COMPONENT IDENTIFICATION
2.1. Overview
1. Monobloc 12. Supply cable
2. Goniometer 13. Handle for unit movement
3. Monobloc handle 14. Control panel
4. Collimator 15. Arm safety lock for transport
5. Supply cable-winding 16. Monobloc support arm
6. Equipotential node 17. Safety lock for monobloc rotation
7. Connector for Potter 18. Selector of HAND-SWITCH – CORDLESS mode
8. X-ray handswitch 19. IR receiver (optional)
9. Foot brake 20. X-ray remote control (optional)
10. Cassette holder 21. Printer for Dose Meter (optional)
11. Magneto-thermic switch 22. Hook for radio protective apron (optional)
23. Tilting pedal (optional)

Figure 1

2.2. Collimator

1. Longitudinal collimation 4. Lamp switching ON for the luminous


2. Extensible meter for focus-skin distance check. irradiation field indication
3. Transversal collimation 5. Guides for the accessories positioning (filters
or DAP dosimeter)

1
3

5 2

Figure 2

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Technix S.p.A. TMS300 - User's Manual

2.3. Control panel

Figure 3

Here is a brief description of the keys function in standard use and the signals meaning.

OFF Unit OFF.

Unit ON, the green led indicates that the unit is connected to the
ON
mains and supplied.

External potter selection, only if the potter is inserted in the proper


POTTER
connector.

Collimator lamp ON.


COLLIMATOR
(the lighting is timed for about 30s)

Small focus selection. The lit led indicates that the selection has
SMALL FOCUS
been done.

Large focus selection. The lit led indicates that the selection has
LARGE FOCUS
been done.

Allows to select HIGH DOSE or LOW DOSE. The led indicates


DOSE
the selection of HIGH DOSE.

Allows scrolling through pages in systems with more than one


MENU
page.

[File: AD3001_E00.doc] Rev.6 - Pag. 7/34


User's Manual - TMS300 Technix S.p.A.

kV+ kV- To modify KV value

mAs+ mAs- To modify mAs value

RESET Return to the main menu.

Function keys: F1, F2, F3, F4


They refer to the display line number (4 lines display).
With dosimeter present and in working conditions (dose
F#
shown on the display), the F4 key allows to print the data
concerning the dose released to the patient on a printer
available as accessory.

READY ON when the unit is ready for radiography.

X-RAY When this led is ON there is x-ray emission

2.4. Audible signals


Here is the list of the most important audible signals:

2 BEEPS Storage ok

3 BEEPS Exposure ok

A LONG BEEP Alarm, malfunction

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Technix S.p.A. TMS300 - User's Manual

2.5. Signals and error messages

The unit foresees three types of alarm that can appear on the display:

• Warnings (WARN)
• Errors (ERR)
• Fatal Errors (FERR)

Warnings (WARN)
When this alarm appears, after taking the proper precautions, it is enough to press RESET on the control
panel to go on to work with the same modes set. In order to interpret the alarm, refer to the tables indicated
successively.

Errors (ERR)
When this alarm appears, after taking the proper precautions, it is enough to press RESET on the control
panel to go on to work with the same modes set. In order to interpret the alarm, refer to the tables indicated
successively. This type of alarm always leaves a trace, in fact the unit stores information about the error (date,
time, kV and mAs) so that the service intervention is made easier.

Fatal Error (FERR)


This alarm does not allow operations to continue on the unit. It’s necessary to switch the unit OFF. This type
of alarm always leaves a trace, in fact the unit stores information about the error (date, time, kV and mAs) so
that the service intervention is made easier.

For the unit operator

Every signal is displayed and appears in the language according to the unit configuration (“ITA”, “ENG”,
“FRE”, “GER”, “SPA”, “POR”)

WARNING SIGNAL FATAL ERROR SIGNAL

ERR o r WA R N FATAL ERROR


MANUA L

6 3 4

The display shows error or warning messages on The display shows the error message on the first
the first line, whilst the other lines show the unit line, whilst the other lines are blank.
status. In this condition it is necessary to turn the unit off,
In this condition press “RESET” on the keyboard wait for some minutes, turn the unit on again and
(see Figure 3) to go on to work with the same set repeat the operations performed previously.
modes. If the same error appears again, it is necessary to
stop the unit use and call Service.

In order to interpret the unit messages, refer to the following pages.

[File: AD3001_E00.doc] Rev.6 - Pag. 9/34


User's Manual - TMS300 Technix S.p.A.

3. MESSAGES ON THE DISPLAY


F = fatal error W = alarm S = unit status

Text Meaning Action


S READY The unit is ready to perform an exposure
S BUSY Preparation phase Wait for “READY” message
S MANUAL
W CLOCK OFF System clock error Press RESET to proceed
Turn off, wait for some minutes, turn on
Charger or Chopper error
F POWER FAULT and if the error appears again, call
Energy not available
Service
Turn off, wait for some minutes, turn on
F V3 FAULT Absence of V3 power supply and if the error appears again, call
Service
W RESET APR APR checksum error Press RESET to proceed
W APR OUT OF RANGE An APR value is out of range Set differently the parameters
After a long idle period (3 months or more)
Press RESET to proceed, call Service for
W TUBE SEASONING it is necessary to proceed with the x-ray tube
the tube seasoning
seasoning in order to avoid severe damages
Turn off, wait for some minutes, turn on
F FILAMENT Absence of filament current and if the error appears again, call
Service
The monobloc temperature has achieved the
W HOT TUBE Wait for the monobloc cooling
max. allowed value
Turn off, wait for some minutes, turn on
Absence of V2 power supply in the set mA
F V2 FAULT and if the error appears again, call
and kV circuit
Service
Press RESET to proceed and repeat
F STARTER INTERLOCK Error during the start time
exposure
F CHOPPER FAULT Chopper error Press RESET to proceed, repeat x-rays
The x-ray handswitch has been pressed at Release the handswitch and repeat
W TIME OUT
the 1st step for more than 15 secs. radiography
kV don't reach the 75% of the set value
Press RESET to proceed and repeat
F LACK OF X-RAY within the first 10ms of exposure or lack of x-
exposure
rays.
The max. exposure time has been achieved Press RESET to proceed and repeat
F MAX TIME
(2s) exposure
Turn off, wait for some minutes, turn on
F DATA ERR. Memory error, data checksum error and if the error appears again, call
Service
The x-ray handswitch has been released
W MAN STOP XR Press RESET to proceed
before the end of exposure
During x-ray emission kV decrease under
75% or increase over 110% of the set value
F INVERTER KV ERROR Press RESET and repeat exposure
or the H.V. circuit has unbalanced during
exposure
F INVERTER OVERLOAD Inverter power out of range Press RESET and proceed
F INVERTER FAULT IGBT drivers error Press RESET and proceed
F TUBE CALIB. ERR. X-ray tube calibration error Call Service
Check the x-ray handswitch integrity, turn
F HAND SWITCH ERR Faulty x-ray handswitch off and on again the unit, then try again.
If the error appears again, call Service
W DAP INACTIVE The dosimeter is not connected -
The doses meter has reached the max.value
- MAX DOSE Press F1+RESET to reset the value
Dosimeter

that can be displayed


S DAP READY The dosimeter is ready -
W DAP ERROR The dosimeter is connected, but in fault Press RESET and call Service
The sum of the product-area doses have
- DAP RESET -
been reset
The Bucky key has been pressed but no potter is Press RESET to proceed and connect a
W PLUG A BUCKY
connected to the unit. Bucky.
After waiting for a short time, no x-ray consent is
W EXT XR ORDER Press RESET and call Service
arrived from the Potter Bucky.

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Technix S.p.A. TMS300 - User's Manual

The table below shows all the messages and signals in the five languages that can be set.

English (GB) Italian (I) French (F) German (D) Spanish (ES) Portuguese (PT)

ENG ITA FRE GER SPA POR


TAKTGEBER
CLOCK OFF ERR.OROLOGIO ERR. HORLOGE FALLO RELOJ ERRO RELOGIO
DEFEKT
STROMVERSORG.
POWER FAULT POTENZA GUASTA ERR. BATTERIE FALLO ACUMUL. POTENCIA FALHA
DEF
V3 FAULT ERRORE V3 V3 DEFECT. V3 DEFEKT FALLO V3 ERRO V3
APR-DATEN
RESET APR INI.APR INI.APR INI.APR INI.APR
DEFEKT
APR OUT OF
ERRORE IN APR ERREUR APR APR-WERT FALSCH FALLO APR ERRO APR
RANGE
ROEHRE FORMACAO
TUBE SEASONING FORM.DEL TUBO FORM. DU TUBE AJUSTE DEL TUBO
ENFAHREN TUBO
FILAMENT FILAMENTO FILAMENT HEIZKREIS-FEHLER FILAMENTO FILAMENTO
HOT TUBE TUBO CALDO TUBE CHAUD ROEHRE HEISS TEMPER. TUBO MORNO
V2 FAULT ERRORE V2 ERREUR V2 V2 DEFEKT FALLO V2 ERRO V2
STARTER STARTER BLOCAGE BLOQUEO STARTER
ANLAUF-FEHLER
INTERLOCK BLOCCATO DEMARREUR CEBADOR OBSTRUIDO
CHOPPER HACHEUR
CHOPPER FAULT CHOPPER-FEHLER FALLO PULSADOR ERRO CHOPPER
GUASTO DEFECT.
TIME OUT TEMPO SCADUTO TEMPS EXPIRE PREP ZU LANG FUERA TIEMPO FORA TEMPO
READY PRONTO PRET BEREIT LISTO PRONTO
BUSY ATTESA ATTENDRE WARTEN ESPERA ATENDIDO
KEINE
LACK OF X-RAY ERRORE RAGGI ERREUR RX SIN RADIACION ERRO RAIOS
STRAHLUNG
MAX TIME TEMPO MAX TEMPS MAX MAX EXP ERREICHT TIEMPO MAX TEMPO MAXIMO
DATA ERR. ERR. DATI ERR. DONNÉE DATEN-FEHLER FALLO DATO ERRO DADOS
EXP INTERRUP. TERMINO
MAN STOP XR STOP MANUALE ARRÊT UTILISAT.
UNTERBROCHEN MANUAL MANUAL
WANDLER KV
INVERTER KV ERR. ERR.KV INVERTER ERR.KV CONVERT. FALLO KV TRANSF ERRO KV INVERTER
FEHLER
INVERTER SOVRACCARICO SURCHARGE WANDLER SOBRECARGA
SOBRECARGA INV.
OVERLOAD INV. CONVERT. UEBERLAST TRANSF
DEFAUT
INVERTER FAULT ERRORE INVERTER WANDLER FEHLER FALLO TRANSF ERRO INVERTER
CONVERT.
ROEHRE
CALIB. TUBE ERR. ERR. CALIB.TUBO ERR. CALIBRAGE FALLO CALIB. ERRO CALIB.TUBO
KALIBRIER.
MANUAL MANUALE MANUEL MANUELL MANUAL MANUAL
HAND SWITCH
ERR.PULSANTE RX BOUTON DEFECT. HANDSCHALT.DEF FALLO MANDO ERRO BOTAO RX
ERR
DAP READY DAP PRONTO DAP PRET DAP BEREIT DAP LISTO DAP PRONTO
DAP INACTIVE DAP INATTIVO DAP INACTIF DAP INAKTIV DAP INACTIVO DAP NAO ATIVO
DAP Reset DAP AZZERATO DAP a zero DAP auf Null DAP en cero DAP ZERADO
DAP ERROR DAP ERRORE DAP ERREUR DAP FEHLER DAP ERROR DAP ERRO
MAXDOSE MAXDOSE MAXDOSE MAXDOSE MAXDOSE MAXDOSE
PLUG A BUCKY COLLEGA BUCKY RELIER BUCKY VERBINDEN CONECT.BUCKY LIGAR. BUCKY
EXT XR ORDER NO RX ESTERNO EXT XR ORDRE AUβENAMTRIEB NO BUCKY NO RX FORA

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User's Manual - TMS300 Technix S.p.A.

4. FUNCTIONING
4.1. Transport
For the transport of the unit, consider the following instructions:

• The unit must be OFF, the supply plug must be removed from the socket outlet and the cable
wound. (See Par. 4.6 “Shutdown procedure”).
• Place the monobloc - collimator group vertically and activate its rotation safety lock (see Figure 4).
• Pull the safety knob and rotate it till it is taken out (see Figure 5).
• Move downwards the arm by using the handles and by keeping in vertical position the monobloc-
collimator group; when the parking position is reached (see Figure 6) rotate and engage the safety
lock.
• Release the parking brake (see Figure 7 and Figure 8)
• Move the unit by using only the proper handles for the transport.
• Don't move the unit on surfaces with inclination higher than 10°.
• In order to overcome obstacles, pull downwards the transport handle and, at the same time, pull
the handle placed on the column.
• In presence of the pedal for tilting (available as accessory on request) press with the foot on the
pedal and, at the same time, pull the the handle placed on the column.

Figure 4 Figure 5 Figure 6


Movements of the monobloc - Safety knob Parking position
collimator group

Figure 7 Figure 8
pos.1: deactivated brake pos.2: activated brake

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Technix S.p.A. TMS300 - User's Manual

4.2. Positioning

For positioning the unit the following instructions should be considered:

Don't move the unit when the brakes are activated. For the movements use the proper handles.

• Pull the safety knob and turn it till it is taken out (see Figure 5).
• For adjusting and positioning the arm height use the handle on the monobloc. (see Figure 8).
• Position the monobloc-collimator assembly over the relevant area of the patient (see Figure 10 -
Figure 11).
• Turn the unit ON (see the paragraph “4.4 “Start up and checks at the ignition”)
• Turn the collimator lamp ON (the lamp will stay on for about 30secs).
• Collimate the x-ray beam to the dimension of the cassette (see the next paragraph)
• If necessary, release the brake to perform this operation (don't forget to set it again!).
• When positioning has been completed, lock all the movements and the parking brakes.

Figure 9 Figure 10 Figure 11

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User's Manual - TMS300 Technix S.p.A.

4.3. Collimator adjustment

1. On the frontal panel of the collimator, there are two knobs for the beam adjustment (width and
length) as well as the push-button to turn ON the collimator lamp (see Figure 12). It is possible to turn
the lamp ON by pressing the COLLIMATOR push-button placed on the control panel.

Figure 12
The extensible meter allows to measure with accuracy the focus-film distance (FFD).

2. If necessary, rotate the collimator (see Figure 13).

Figure 13

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Technix S.p.A. TMS300 - User's Manual

4.4. Start up and checks at the ignition

1. Connect the unit to the mains. Insert and turn the safety key in ON position (Fig.1 pos. 18), the
presence of the power supply voltage is indicated by the switching ON of the yellow led placed near
the ON key (Fig.3). If, with the plug inserted, the led is off, check that the automatic switch lever
(Fig.1 – pos.11), placed on the unit side, is up (ON position).
2. Turn the unit ON by pressing ON key (Fig.3), follow step by step the Start up phase and check its
performance by comparing it with the following one:
• check of the display: every digit is completely ON (every pixel is dark);

• check of leds and beepers: all the leds of the keyboard turn ON and the beeper emits a
prolonged sound;
• software version:

without dosimeter

UN I T NAME
VER X . XX . XX

with dosimeter
DAP XXXXXXXX
UN I T NAME
VER X . XX . XX

XXXXXXXX can have the following values:

READY: the reading of the chamber is enabled and it works properly


ERROR: the reading of the chamber is enabled but it does not work properly, it is not present or it is not
connected.
INACTIVE: status displayed after ERROR signal and after pressing the key RESET.

If the DAP is accepted to the test, the writing READY appears and the system goes on.
If it is not accepted, the writing ERROR appears and the audible error alarm is activated.
At this point it is necessary that the operator intervenes; by pressing the key RESET it is possible to go on
with the start up of the unit by indicating DAP INACTIVE.

• phase of capacitors battery charge:

Start Up: on the unit it is possible to set the radiological data, including the APR, but it is not possible to
perform an exposure till the writing “READY” appears on the display

BUSY
MANUA L

63 4

3. When the Start up is finished, the writing “READY” will appear on the display, the unit is ready for
use.

RE A D Y
MANUA L

6 3 4

If it does not occur, it is probable that the unit is faulty or that there are some malfunctions, contact the
authorized service personnel.

[File: AD3001_E00.doc] Rev.4 - Pag. 15/34


User's Manual - TMS300 Technix S.p.A.

4.5. Exposures
4.5.1. Operative procedure
Set the exposure data by following the operative procedure here below.

IGNITION & START UP

Press RESET to return


MANUAL MODE
to MANUAL MODE
R E ADY
MANU A L

63 4
Upon ignition the unit is in MANUAL MODE Press MENU to
proceed to APR
MODE

ANATOMIC PROGRAMMED MODE (APR)


Adjust the radiological S K U L L / A B D OM E N 1 / 4
parameters by pressing kV T h o r a x a p
+/- and mAs +/- keys. S k u l l
d Ce r v i c a l S p i n e
Press the DOSE Key to The first line shows the name of the exams group, the
enable / disable the Dose others show the 1st page of the exams of that group.
Reduction function. Every group is composed by 6 exams, press MENU to
shift to the 2nd page.
S K U L L / A B D OM E N 1 / 4
c L umb a r S p i n e a p
A b d ome n a p
P e l v i s a p

Press F1 to shift to the next group.


U P P E R E X T R EM I T . 2 / 4
S h o u l d e r ap
PRESS X-RAY HANDSWITCH TO C l a v i c l e
PERFORM EXPOSURES d Hume r u s / e l b ow

Press F2, F3 or F4 to Press F2 to return to


select the proper APR menu
program

PROGRAM DISPLAY
R EADY
P ED I A T R I CS
I n f a n t L u n g 1 . 5 k g
60 0 . 4
1st line: reserved to messages
2nd line: selected group
3rd line: program name
4th line: radiological parameters (kV & mAs)

The modification of some x-ray parameters in


respect of the stored values is indicated by the
asterisk (*) placed near the program name (3rd
line).
In order to store the new values, it is necessary to
press F3 and, by holding it down, press the
MENU Key.

Pag. 16/34- Rev.6 [File: AD3001_E00.doc]


Technix S.p.A. TMS300 - User's Manual

4.5.2. Programs for the Anatomical programming mode (APR MODE)

Here is a table with the APR default values. Consider that they are valid by placing the x-ray tube with a SID
(Source-Image receptor Distance) of 100 cm without grid.
In case of cassettes with grid it is necessary to increase the mAs values by four increments.

SC
Folder Part of Body kV mAs Cartella Part of Body kV mAs SC [DIN]1
[DIN] 1
Thorax ap 85 3.2 200 Hip/Femur 74 5.0 400
1/4 3/4
SKULL /Skull 78 5.0 400 LOWER Knee 66 4.0 200
ABDOMEN Cervical Spine 66 6.3 400 EXTREMITIES Lower Leg 60 4.0 200
Lumbar Spine ap 78 6.3 400 Ankle 55 4.0 200
Abdomen ap 85 5.0 400 Calcaneus 52 3.2 200
Pelvis ap 77 3.2 400 Foot 48 2.0 200
Shoulder ap 66 16.0 200 Thorax 1.0 Kg 60 0.2 400
2/4 4/4
Clavicle 66 10.0 200 Thorax 2.0 Kg 62 0.4 400
UPPER CHILDREN
Humerus/elbow 60 4.0 200 Thorax 4.0 Kg 72 0.4 400
EXTREMITIES Added Filter
Forearm 52 3.2 200 1mmAl + Thorax 6.0 Kg 74 0.4 400
Wrist 48 2.5 200 0,2mmCu 2 Thorax 8.0 Kg 76 0.4 400
Hand ap 46 2.5 200 Thorax 10 Kg 76 0.63 400

Here is the list of the APR programs and groups names in the five settable languages.

APR Groups and Programs

English (GB) Italian (I) French (F) German (D) Spanish (ES) Portuguese (PT)
CRÁNEO/
SKULL/ABDOMEN CRANIO/ADDOME CRANE/ABDOMEN SCHÄDEL/ABDOMEN SKULL/ABDOMEN
ABDOMEN
Thorax ap Torace ap Thorax ap Thorax ap Tórax ap Thorax ap
Skull Cranio Crane Schädel Cráneo Skull
Cervical Spine Spina Dorsale Col.Cervical HWS Columna Cerv. Espinho Dorsal
Lumbar Spine ap Spina Lombare Col.Lumbaire LWS ap Columna Lumb. Espinho Lumbar
Abdomen ap Addome ap Abdomen ap Abdomen ap Abdomen ap Abdomen
Pelvis ap Bacino ap Bassin ap Becken ap Pelvis ap Pelvis
UPPER EXTREMIT. ESTREMITÁ SUP. EXTREMITES SUP. OBERE EXTREMIT. EXTREM. SUPERIOR EXTREM.AVANCADA
Shoulder ap Spalla ap Epaule ap Schulter ap Hombro Hombro
Clavicle Clavicola Clavicule Schluesselbein Clavícula Clavicola
Humerus/elbow Omero/Gomito Humerus/Coude OA/Ellenbogen Húmero/Codo Omero/Cotovelo
Forearm Avambraccio Bras inf. Unterarm Antebrazo Forearm
Wrist Polso Poignet Handgelenk Muñeca Pulso
Hand ap Mano ap Main ap Hand ap Mano ap Mao ap
LOWER EXTREMIT. ESTREMITÁ INF. EXTREMITES INF. UNTERE EXTREMIT. EXTREM. INFERIOR EXTREM.INFERIOR
Hip/Femur Fianco/Femore Hanche/Femur Huefte/OS Cadera/Fémur Flanco/Femore
Knee Ginocchio Genou Knie Rodilla Joelho
Lower Leg Gamba inf. Jamb inf. US Tibia/Peroné Pe' inferior
Ankle Anca Art.Tibio Tors. Fussgelenk Tobillo Hip
Calcaneus Calcagno Calcaneum Fersenbein Calcáneo Salto
Foot Piede Pied Fuss Pie Pe'
CHILDREN BAMBINI ENFANTS KINDER NIÑOS CRIANCAS
Thorax 1.0 Kg Torace 1.0 Kg Thorax 1.0 Kg Thorax 1.0 Kg Tórax 1.0 Kg Thorax 1.0 Kg
Thorax 2.0 Kg Torace 2.0 Kg Thorax 2.0 Kg Thorax 2.0 Kg Tórax 2.0 Kg Thorax 2.0 Kg
Thorax 4.0 Kg Torace 4.0 Kg Thorax 4.0 Kg Thorax 4.0 Kg Tórax 4.0 Kg Thorax 4.0 Kg
Thorax 6.0 Kg Torace 6.0 Kg Thorax 6.0 Kg Thorax 6.0 Kg Tórax 6.0 Kg Thorax 6.0 Kg
Thorax 8.0 Kg Torace 8.0 Kg Thorax 8.0 Kg Thorax 8.0 Kg Tórax 8.0 Kg Thorax 8.0 Kg
Thorax 10 Kg Torace 10 Kg Thorax 10 Kg Thorax 10 Kg Tórax 10 Kg Thorax 10 Kg

1 SC is the sensitivity class. According to DIN 6867-10, a class 400 film/screen system (SC=400) can cover a sensitivity range
of Smin=320 DIN to Smax=560 DIN. From the derived dose value Ks the tolerance for S will be approx. ±30%.
2 The filter combination of 1 mmAl + 0,1 mmCu is also permissible

[File: AD3001_E00.doc] Rev.6 - Pag. 17/34


User's Manual - TMS300 Technix S.p.A.

4.5.3. Perform an exposure


TMS300 provides for two different modes to perform an exposure:
• HANDSWITCH mode: the exposure is performed with the x-ray
control supplied with the unit.
• CORDLESS mode: the exposure is performed with the infrared
remote control available as accessory.
In order to change the x-ray control mode, it is enough to bring the choice
switch on the mode fitter for use.

HANDSWITCH Mode

Before performing an exposure, make sure that all the necessary precautions against radiation
have been taken.

After a long idle period (3 months or more) it is very important to proceed with the X-RAY TUBE
SEASONING. It is necessary to avoid high voltage discharges that could be destructive for the X-
ray tube. The seasoning procedure is described in the Service Manual.

• Keep away as much as possible from the x-ray


source
• If on the display "READY" appears and the READY
led is ON, the exposure can be controlled.
• The emission control is made up of a two-steps
switch.
1°step: preparation (about 1 s)
2°step: exposure control

• It is possible to press the exposure control at once 1° step “prep” 2° step “rad”
(second step). Then there is a delay of about 1.2 Figure 14
s before the real exposure.
• Hold the x-ray control down till the exposure has
been performed properly (3 beeps).

The x-ray handswitch activates both the x-ray preparation phase “prep” and the emission phase “rad”. The
Figure 14 shows how to operate the handswitch to activate the preparation and the emission phases. It is not
possible to activate the emission phase “rad” without preparation; however, it is possible to perform
preparation without activating the emission.

The most frequent alarms during the use of the x-ray handswitch are the following:

1. TIME OUT – The x-ray handswitch has been pressed at the “1st step” (preparation) for more than 15s. In
order to perform radiography, it is necessary to release the handswitch and repeat the procedure.
2. MAN STOP RX – The x-ray handswitch has been released before the end of exposure. In this case, the
display will show the radiological data obtained. In order to repeat the exposure, it is necessary to press
RESET.
CORDLESS Mode
The x-ray infrared control has got two push-buttons, one
for the lighting-ON of the collimator lamp and one for
activating both the x-ray preparation phase “prep” and LAMP
the emission phase “rad”. LOW
Lamp lighting-ON – For lighting ON the collimator lamp BATT
press the relative key, the lamp will light OFF after the
lighting-ON time of 30sec.
Preparation phase “prep” – press and release the push-
button “prep + rad”.
Emission phase “rad” – Press twice the x-ray push- button
PREP +
“prep + rad” within 15sec. and hold it down till the
RAD
exposure is finished. When the exposure has been
completed, the unit emits three beeps. Put the remote
control in its seat on the unit again.

Pag. 18/34- Rev.4 [File: AD3001_E00.doc]


Technix S.p.A. TMS300 - User's Manual

4.5.4. Useful information


• Only if the display shows the writing “READY” and the READY led is ON, it is possible to
perform an exposure.
• The 1st line of the display shows the use messages and the error signals.
• The 4th line of the display shows the radiological parameters.
• After every exposure, the 4th line shows the radiological parameters and, in the middle, the
exposure time.
• While shifting from APR MODE (Anatomical programming) to the MANUAL MODE,
radiological parameters do not change.
4.5.5. Optional: dosimeter (DAPmeter)
The unit can be supplied, on request, with a ionizing chamber dosimeter (dose-area product meter, DAP
meter) installed. The DAPmeter function is to measure the dose-area product [cGgcm2] in output towards the
patient.
The device that can be installed is type PTW-Freiburg DIAMENTOR CI-P.
Only authorized service personnel can perform the installation and the maintenance of the dosimeter.

If DAPmeter has been installed and it works properly, the first line of the display shows alternatively the
measures summation and the measurement unit [cGycm2]:

READY 0 00 0 . 0 0

READY c G y cm2

The measures summation is the sum of all the dose-area products read by the chamber. By pressing
F1+RESET, the value resets.
n

∑ dosei ⋅ areai
i =1
“n” is the number of exposures performed after the last time that F1+RESET has been pressed.

In order to determine the correct Dose Area Product to which the patient has been exposed, it is necessary to
press F1+RESET between each patient.
The possible measuring range is included between 0000,00cGycm2 and 9999,99cGycm2. When the
measures summation exceeds 9999,99cGycm2, the message “MAXDOSE” will appear. The presence of this
message does not exclude the possibility to perform exposures.

Data printing
If the DAP meter is installed and works properly (dose shown on the display), by pressing the F4 key it is
possible to print the data concerning the dose released on a dedicated printer, available as accessory on
request.

The final printing relates the data concerning:

Datum Description
Name/Id................ Patient’s name (*)
Born on ............... Birth date of the patient (*)
xxxx.xx cGycm2 Dose to which the patient has been exposed (0000.00 cGycm2)
Operator.............. Operator’s signature (*)
Date Date and time of the exam (format dd-mm-yy hh:mm)

(*) datum to be inserted by hand from the operator.

Connect the printer to the connector placed on the front of the unit; Switch ON the printer; press the F4 key,
on the display the “Print” writing appears.

For more details and / or explanations on the printer, refer to the User’s Manual of the printer.

[File: AD3001_E00.doc] Rev.6 - Pag. 19/34


User's Manual - TMS300 Technix S.p.A.

4.5.6. Optional: Radiography with examination table and Potter Bucky grid

The examination table or the Potter Bucky that can be connected to the unit must be according
to the Medical Devices Directive EEC 93/42.

After positioning the cassette and the patient, follow these instructions:

1. connect the Potter Bucky grid or the table for the examination to the socket outlet placed on the
frontal unit part;
2. press the push-button for the Potter Bucky selection, if the potter works properly the led of the key
turns on;
3. place monobloc and collimator, set the exposure field as shown previously;
4. lock the parking brake;
5. select manually the values of kV and mAs or in APR mode, by choosing the data about the
examination that you need to perform;
6. pick up the x-ray handswitch;
7. keep away at least 2m from the x-ray tube;
8. press and hold down the handswitch in "prep" position for the preparation (about 1.2s);
9. press the x-ray handswitch in "rad" position;
10. hold down the x-ray handswitch till the exposure time is finished. The end of the exposure is
indicated by three Beeps emitted by the audible signal of the unit.

Note: occasionally when the potter grid has been selected “non consent to proceed” may appear, in this case
check the connection.

Note: it is possible to press the x-ray handswitch fully ("rad" position) from the beginning. In this case the x-ray
exposure will be performed automatically after the preparation.

4.6. Shutdown procedure

Ensure unit is switched off before removing the connector from the mains outlet

When finished the examination, do the following:

1. Turn the unit off by operating the OFF key located on the control panel
2. Disconnect the supply cable and wrap it on the proper support.
3. Place the unit in parking position (down, with mechanical brakes activated).

Pag. 20/34- Rev.4 [File: AD3001_E00.doc]


Technix S.p.A. TMS300 - User's Manual

5. MAINTENANCE

Technix S.p.A. can supply, on request, a programmed maintenance plan to be performed on the unit.

5.1. General Warnings


As with any medical device, this system requires:
• proper use;
• regular checks by the user;
• maintenance and repairs by the authorized personnel.
Operational reliability of the unit is kept by following these precautions.

Technix S.p.A. can provide, on request, circuit drawings, parts list, adjustment instructions or further
information for the unit repair.

As users of x-ray units it is necessary to take these precautions in compliance with the
prevention standards formulated by the laws concerning the medical equipment.

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 during normal use of the equipment. 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 as a
result of the breakage of any mechanical parts..
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 personnel and patients are 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.

5.2. Checks and inspection by the user

The user must check the x-ray unit as indicated in the table below. In the event of operational faults or other
deviations in respect of the standard operative behaviour, the user must turn off the unit. The unit may only be
operated after repairs have been made.

If a faulty or malfunctioning unit is used, risks to the operators and patients can increase.

Summary of the periodical checks


Daily: Check the functionality of alarms, displays and indicators.
Check the warning and danger labels integrity.
Weekly: Check for oil leakage from the monobloc.
Check unusual noises in the monobloc during x-ray emission
Check the x-ray tube and collimator centering
Every 6 months: Check the brakes and the directional handle functionality.
Yearly: Contact the technical after-sale service to perform the constancy and
reproducibility tests, as indicated by IEC 1223-2 and IEC 1223-11 standards,
as well as the other operating tests of the unit, as instructed in the programmed
maintenance plan. (see Service Manual).

[File: AD3001_E00.doc] Rev.4 - Pag. 21/34


User's Manual - TMS300 Technix S.p.A.

5.3. Cleaning
Please take the following information into consideration before choosing a detergent:
• To clean plastic surfaces, simply use water and soap, and nothing else. If other detergents are used (e.g.
with a high alcoholic content, or corrosive solvents, or abrasive detergents), the material will tend to
break or opacify.
• To clean enameled parts and aluminium surfaces, simply rub them with a wet cloth and a delicate
detergent, after that rub them with a dry wool cloth.
• As regards, chromium-plated surfaces, only rub them using dry wool clothes; do not use any detergent.
• To clean the other surfaces of the equipment, never use highly alcoholic products, corrosive or abrasive
detergents and solvents

Before cleaning the unit, please take the following actions:


• Turn off the unit and unplug the mains power supply cable.
• Ensure that no liquid seeps into the unit, so as to avoid short-circuiting or corroding the electrical and
electromechanical parts.

5.4. Disinfection
To disinfect the equipment it’s advisable to use a common liquid solution featuring an aldehyde base or
disinfectants featuring an ampholytic surface-active agent base (e.g. Tego 103, Korsolin).
Substitute disinfectants releasing chlorine or based on phenols are likely to weaken the materials, hence they
are much to be avoided. The same limitations apply to undiluted solutions featuring a high alcoholic content.
Do not use disinfectant spray; it might penetrate the system, and its safety would not be guaranteed any
longer (damages possibly affecting electrical and electromechanical parts, formation of flammable air
mixtures and vapor solutions).

In cases where there is a danger that disinfection products may form inflammable or explosive
gaseous mixtures, always ensure that such gases have dispersed before re-using the
equipment.

Pag. 22/34- Rev.4 [File: AD3001_E00.doc]


Technix S.p.A. TMS300 - User's Manual

6. TECHNICAL DATA
6.1. Electrical data

Description Data
Voltage 115/230Vac ±10% standard monophase with automatic unit prearrangement in
function of the mains (plug & play).
Frequency 50/60Hz standard
Absorbed current Values of current absorbed by the unit in the different operative conditions and in
the two power supply values:
Operative condition 115 Vac / 50Hz 230 Vac / 50Hz
Charger On 5,5 AMAX 3,4AMAX
Stand By 0,87A 0,58A
Stand By + Collimator Lamp 2,3A 1,5A
Stand By + Charger On 5,1A 3,0A
Stand By + Collimator Lamp + Charger On 6,7A 3,8A
Preparation 4,3A 5,5A
Preparation + Collimator Lamp 5,5A 7,3A
X-ray emission + Collimator Lamp 3APK 3APK
Line compensation Automatic
Line resistance <1Ω @115/230Vac
Standard socket outlet 16A @230Vac
Isolation class Class I with applied parts type B
Use conditions Continuous functioning with intermitting load
The unit is not suitable to the use where danger of inflammable mixtures with air or nitrous oxide exists.

6.2. Functioning features


Description Data
User’s interface Keyboard with LCD alphanumeric display, 4 lines X 20 characters for all the
operative parameters and messages of possible faulty status.
Service program for faults finding.
Microprocessor management.
Settable languages Italian, English, French, German, Spanish, Português, through configuration
program
Radiography control By handswitch with extendible cable. It is proposed the use of the last kV
value used in manual mode or APR.
Upon the ignition, the unit is in manual mode with default values.
Safeties Filament current
Monobloc temperature
Overload
Max kV or H.V. fault
Stored data check
Microcontroller auto test

[File: AD3001_E00.doc] Rev.6 - Pag. 23/34


User's Manual - TMS300 Technix S.p.A.

6.3. Radiological data

Data Dati
Working technique 2 points with kV and mAs setting
APR technique 24 exams storage (4 folders each of 6 exams) available in
the 5 different selectable languages.
Exposure control Constant kV and mA during all the exposure
Dose A 50% reduction (LD)
Small focus (IEC 60336) 0,8mm
Large focus (IEC 60336) 1,3mm
Generator power in DC current 30kW@100kV
Inverter frequency 20kHz
Inverter frequency in high voltage 40kHz
Max.ripple <2% @100kV,
(100kV,100ms, 300mA)
Rise time <2ms @100kV
kV range 40 ÷ 125kV in step of 1kV
mA range @115/230Vac 50 ÷ 300mA automatically associated to kV
mAs range @115/230Vac 0,2 ÷ 220mAs steps with increases of 12,5%
Times range @115/230Vac 0,002 ÷ 2,2s
in function of the set mAs
Use coefficient (duty cycle) 1:40

mA values @115/230Vac mAs value in function of kV


Small focus Large focus @115/230Vac
kV
H.P. L.P. H.P. L.P. mAs (HD) mAs (LD) kV
(t<100ms) (t>100ms) (t<100ms) (t>100ms) 0.2-220 0.2-110 40
40 200mA 100mA 200mA 200mA 0.2-200 0.2-100 41-45
50 200mA 100mA 250mA 200mA 0.2-180 0.2-90 46-52
0.2-160 0.2-80 53-62
60 190mA 95mA 300mA 190mA
0.2-140 0.2-70 63-72
70 180mA 90mA 300mA 180mA 0.2-110 0.2-55 73-92
80 170mA 85mA 300mA 170mA 0.2-100 0.2-50 93-112
90 160mA 80mA 300mA 160mA 0.2-90 0.2-45 113-125
100 150mA 75mA 300mA 150mA
110 130mA 65mA 260mA 130mA
120 115mA 55mA 220mA 110mA
125 110mA 50mA 200mA 100mA

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Technix S.p.A. TMS300 - User's Manual

6.4. Environmental data


Description Normal use Transport and storage
Temperature From +10°C to +40°C From -25°C to +70°C
Relative humidity From 30% to 75% non condensing From 10% to 90% non condensing
Pressure From 700 to 1060hPa From 500 to 1060hPa

6.5. Mechanical data

Description Data
Weight approx.185 Kg (408 Lb)
Max. width 700mm (27,56in.)
Length in transport position 1338mm (52,68in.)
Max. height in transport position 1458mm (57,40in.)
Max. height with the arm at the max. extension 2258mm (88,90in.)
Control panel height 1000mm (39,37in.)
Focus-floor distance 456 ÷ 2018mm (17,95 ÷ 79,45in.)
Arm rotation around the vertical axis n.a.
Monobloc rotation around the arm axis ±180°
Monobloc rotation around its axis 151° (+133° ÷ -18° in respect of the vertical axis)
Max. height of the front unit leg 105mm (4,13in.)
Cassette holder 5 cassettes format 35 x 43cm (12x15in.)
Movement Manual.
Double front swiveling wheel.
Parking brake
Handle for tilting (obstacles overcoming)
Wheels diameter Rear:
wheel Ø250mm (9,84in.) width 50mm (1,97in.)
Front:
double wheel Ø 80mm (3,15in.) width 22mm (0,87in.)

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User's Manual - TMS300 Technix S.p.A.

6.5.1. Unit sizes

Figure 15

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Technix S.p.A. TMS300 - User's Manual

6.6. Components specifications


6.6.1. Generator

Description Dati
Inverter IHF 2030
Working frequency 20kHz max
Power supply 680Vdc max
Dimensions 240x210x140 mm
9,45x8,27x5,51 in.
Max. absorbed current 75A
Technology IGBT
Safeties overcurrent
overvoltage
IGBT driver fault
Generator power in constant DC current (IEC 601-1) 30kW
(300mA @ 100kV per 0.1s)
Max. voltage to the tube 125kVp
Max. ripple at 100kVp <2%
Rise time at 100kVp <2 ms
Max. current in radiography 300mA

[File: AD3001_E00.doc] Rev.4 - Pag. 27/34


User's Manual - TMS300 Technix S.p.A.

6.6.2. Tube-Housing Assembly


X-Ray Tube

Description Data
Type X22 0.8/1.3
Nominal anode power (IEC 613, EN 60613) 16kW/32kW
Nominal foci size (IEC 336, EN 60336) 0.8mm – 1.3 mm
Speed of rotation 2850 rpm @ 50Hz
Anode diameter 64mm (2,52in.)
Anode material Tungsten
Anode angle 15°
Min. inherent filtration (IEC 522) 0.7mmAl eq.
Thermal anode capacity 80kJ (107kHU)
Max. continuous anode dissipation 300W
Max. anode cooling speed 22kJ/min (29.5kHU/min)
Nominal high-voltage 130kV
Max. filament current 5.4A
Tube seasoning
After a long idle period (3 months or more), it is necessary to proceed to the X-RAY TUBE SEASONING. The
procedure and the tube seasoning modes are described in the Service Manual.

Dimensions Heating and cooling curves of anode


Stored energy (kJ) / Time (min)
80
800 W 500 W
Energia Accumulata - Stored Energy - Energie Emmagas

70
300 W
60
200 W
50

40 100 W
(kJ)

30

20

10

0
0 5 10 15
Tempo - Time - Temps (min)

Figure 16 Figure 17

Single load curves Single load curves


0.8 - 3~ - 3000min-1 1.3 - 3~ - 3000min-1
Anodic current (mA) / Exposure Time (s) Anodic current (mA) / Exposure Time (s)
350 700
Corrente Anodica - Tube Current - Intensité Anodiqu

Corrente Anodica - Tube Current - Intensit Anodique

300 600

250 50 kV 500
50 kV
60 kV 60 kV
70 kV 70 kV
200 400
80 kV 80 kV
(mA)

90 kV 90 kV
(mA)

100 kV 300 100 kV


150
110 kV 110 kV
120 kV 120 kV
200 130 kV
100 130 kV

50 100

0 0
0.01 0.1 1 10 0.01 0.1 1 10
Tempo di esposizione - Time - Temps (sec)
Tempo di esposizione - Time - Temps (sec)

Figure 18 Figure 19

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Technix S.p.A. TMS300 - User's Manual

Monobloc
Description Dati
Monobloc MHF 2030
Weight 20kg (44,09Lb)
Dimensions 320x140x255mm (12,60x5,51x10,04in.)
X-ray tube X22 0.8/1.3
Anode Rotating (2850rpm at 50Hz)(3400rpm at 60Hz)
External thermostat 57°
Thermal monobloc capacity 600kJ (800kHU)
Max continuous thermal dissipation of monobloc 55W
Max. monobloc anode cooling speed 5,4kJ/min (7,2kHU/min)
Total filtration 1.1mm Al
Leakage radiation <1mGy/h according to IEC 601-1-3
Loading, heating and cooling curves See the enclosed diagrams
H.V. transformer insulation Oil bath

Dimensions

Figure 20

Heating and cooling curves of monobloc


Stored energy (kJ) / Time (min)

Figure 21

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User's Manual - TMS300 Technix S.p.A.

6.6.3. Collimator
Description Data
Type, brand and model Manual with internal light source (Ralco R221)
Collimator Square field, multilayers
Light source Halogen Lamp 12V 100W with timed switching-on at
approx. 30s
X-ray field 43x43cm (16,93x16,93in.) at 1m (39,37in.) DFF
Luminous intensity 160lux at 1m (39,37in.) DFF
Contrast ratio 4:1
Measurement of focus-film distance Extractable meter
Rotation ±115°
Weight 8,4kg (18,52Lb)
Sizes 183x168x256mm (7,20x6,61x10,08in.)
Accessories Prearrangement to insert the dosimeter
Max protection against leaked radiation 125kV 4mA
(EN60601-1-3 par.29.204.3)
Indicator accuracy It corresponds to the x-ray fields with tolerance lower than
(EN60601-1-3 par.29.202.8) 2% of used FFD
Inherent filtration 2.0mmAl eq.
(EN60601-1-3 par.29.201.2/29.201.6)
Light field accuracy It corresponds to the x-ray fields with tolerance lower than
(EN60601-1-3 par.29.202.9) 2% of the used FFD.
Classification EN60601-1 par.5
Protection against electrical hazards Class I
Protection against direct and indirect contacts Unit with applied part Type B
Protection against water penetration Common protection (IPXO)

6.6.4. DAP meter (dose-area product meter) (optional)


This device is installed only on request.

Description Data
Type, brand and model Dosimeter with ionization chamber, PTW-Freiburg
DIAMENTOR CI-P
Measurement unit cGycm2
Resolution 0,01cGycm2
Dose-area product summation range 0000,00 ÷ 9999,99 cGycm2
Max. measuring range 118mm x 118mm (4,65x4,65in.)

6.6.5. Printer for DAP (optional)


This device is installed only on request.

Description Data
Type S’Print-S
Printing method Thermal line printing
Resolution 203dpi
Printing speed >50mm/sec (it depends on the printing typology and the
environment temperature)
Paper width (mm) 58mm
Roll dimensions (mm) 57.5 ±1
Print area 48mm
Interface RS-232
Power Supply 18±24VDC / 0,6A
Power consumption (print) 925mA
Temperature, Operatine, Storage 0±50°C
-20±70°C, without paper roll
Humidity, Operating, Storage 10±85%, without condensation
10±90%, without condensation, without paper roll
Dimensions (WxDxH) 146 x 88 x 65mm
Weight 370gr (without paper roll
Safety EN60950+A1+A2+A3+A4

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Technix S.p.A. TMS300 - User's Manual

6.7. Accessories and options


Description
X-ray handswitch with extendible cable Standard
Ionization chamber dosimeter, mod. DIAMENTOR CI-P Optional
X-ray infrared remote control, mod. TECH SWITCH Optional
Printer for dose meter, mod. S’Print-S Optional
Hook for radio protective apron Optional
Tilting pedal Optional

6.8. Compliance with Directives and Technical Standards


Reference Description
MDD 93/42/EEC Medical Devices Directive (CE mark)
IEC 60601-1 Medical devices safety
IEC 60601-1-2 Electromagnetic compatibility
IEC 60601-1-3 Protection against ionizing radiation
IEC 60601-1-8 General requirements, tests and guidance for alarm systems in medical
electrical equipment and medical electrical systems
IEC 60601-2-7 2nd edition High voltage generators
IEC 60601-2-28 Tube – housing groups
IEC 60336 X-ray tubes focus

6.9. Labels and symbols

Figure 22

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User's Manual - TMS300 Technix S.p.A.

Reference Figure 22

Pos.1. – Unit label Pos.2. – Monobloc label

Pos.3. – Collimator label Pos.4. – Potter Bucky label

Pos.5. – Equipotential Node label Pos.6. – Tilting label

Pos.7. – Braking indication label Pos.8. – WEEE label

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Technix S.p.A. TMS300 - User's Manual

6.9.1. Internal symbols

Protective ground clamp

Dangerous voltage

Precautionary warning

6.9.2. Various symbols

Selection of
HAND SWITCH –
Unit OFF Unit Type B
CORDLESS
mode

Unit ON Total filtration Large focus

Ionizing radiation Alternate voltage Small focus

6.9.3. Packing label


It is stuck outside the packing with red writings on white background.

Upper edge of the


Fragile Protect from rain
packing

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User's Manual - TMS300 Technix S.p.A.

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Document status TMS300 – User's Manual

DOCUMENT STATUS

Rev. Date Pages Modification description


0 26.08.03 - Document approval
Updated paragraph “Applications & use destination”
1 25-07-02 4-34
Updated unit’s labels
2 14-01-04 All General revision
3 21.01.05 6, 18, 19, 30, 32 Introduction of the x-ray remote control accessory.
Introduced position of WEEE label.
Introduced explanation note of the WEEE symbol
4 31.10.05 tutte
(+repaging).
Updating of the unit labels and symbols.
Updating of the monobloc and unit labels according to the
5 10/07/06 32
standards in force.
5, 6, 7, 8, 9, Introduced the function of the half dose.
6 05/12/06 10, 11, 12, 16, Introduced the new dose meter chamber, printer for
17, 19, 23, 24, 30 dosimeter, tilting pedal, portuguese language on the display.

Introduction of the technical data of the DAP printer and the


7 21/05/07 30, 31 standard with the general requirements of the electromedical
systems

8 26/10/09 5, 32 Upgrading of manufacturer address and relative S/N labels

[File: AD3001_E00R08.doc] Pag. I/I

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