TECHNIX TMS300 Mobile X-ray System User's Manual

TECHNIX TMS300 Mobile X-ray System User's Manual
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The TECHNIX TMS300 Mobile X-ray System is a compact and maneuverable unit that is easy to transport through obstacles such as doors, small rooms, narrow aisles and lifts. It is designed with an ergonomic design for excellent visibility during operation and movement, and the perfectly balanced monobloc arm allows free movement and positioning even in awkward positions. The unit can be used in a variety of clinical applications, such as operating theaters, sport medicine, plaster rooms, first aid, pediatrics, and orthopedics.

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TECHNIX TMS300 Mobile X-ray System User's Manual | Manualzz

T E C H N I X

Revision: 8

Version:

File:

26 October 2009

[AD3001_E00R08.doc]

U s e r ’

’ s M a n u a l l

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

(This page is intentionally left blank)

Technix S.p.A.

[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.

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.

• 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.

• 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

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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.

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.

Pag. 4/34- Rev.4

[File: AD3001_E00.doc]

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.

[File: AD3001_E00.doc] Rev.8 - Pag. 5/34

User's Manual - TMS300

2.1. Overview

1. Monobloc

2. Goniometer handle

4. Collimator cable-winding

6. Equipotential

7. Connector for Potter handswitch

9. Foot

10. Cassette holder

11. Magneto-thermic switch

Technix S.p.A.

12. Supply cable

13. Handle for unit movement

14. Control panel

15. Arm safety lock for transport

16. Monobloc support arm

17. Safety lock for monobloc rotation

18. Selector of HAND-SWITCH – CORDLESS mode

19. IR receiver (optional)

20. X-ray remote control (optional)

21. Printer for Dose Meter (optional)

22. Hook for radio protective apron (optional)

23. Tilting pedal (optional)

Figure 1

2.2. Collimator

1. Longitudinal

2. Extensible meter for focus-skin distance check.

4. Lamp switching ON for the luminous irradiation field indication

5. Guides for the accessories positioning (filters or DAP dosimeter)

4

1

3

Pag. 6/34- Rev.6

5

Figure 2

[File: AD3001_E00.doc]

2

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

Figure 3

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

ON

POTTER

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

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

COLLIMATOR

Collimator lamp ON.

(the lighting is timed for about 30s)

SMALL FOCUS

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

LARGE FOCUS

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

DOSE

MENU

Allows to select HIGH DOSE or LOW DOSE. The led indicates the selection of HIGH DOSE.

Allows scrolling through pages in systems with more than one 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

F#

READY

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 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.

ON when the unit is ready for radiography.

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

Here is the list of the most important audible signals:

2 BEEPS Storage ok

3 BEEPS Exposure ok

A LONG BEEP Alarm, malfunction

Pag. 8/34- Rev.6

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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

E R R o r W A R N F A T A L E R R O R

6 3 4

The display shows error or warning messages on the first line, whilst the other lines show the unit status.

The display shows the error message on the first line, whilst the other lines are blank.

In this condition it is necessary to turn the unit off,

In this condition press “RESET” on the keyboard

(see Figure 3) to go on to work with the same set

modes. wait for some minutes, turn the unit on again and repeat the operations performed previously.

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

S READY

F V3 FAULT

Text

S BUSY

S MANUAL

W CLOCK OFF

Meaning

The unit is ready to perform an exposure

Preparation phase

System clock error

Charger or Chopper error

Energy not available

Absence of V3 power supply

Action

Wait for “READY” message

Press RESET to proceed

Turn off, wait for some minutes, turn on and if the error appears again, call

Service

Turn off, wait for some minutes, turn on and if the error appears again, call

Service

Press RESET to proceed

Set differently the parameters

W RESET APR APR checksum error

W APR OUT OF RANGE An APR value is out of range

After a long idle period (3 months or more) it is necessary to proceed with the x-ray tube seasoning in order to avoid severe damages

Press RESET to proceed, call Service for the tube seasoning

F FILAMENT Absence of filament current

Turn off, wait for some minutes, turn on and if the error appears again, call

Service

The monobloc temperature has achieved the max. allowed value

Wait for the monobloc cooling

F STARTER INTERLOCK

- DAP RESET

W PLUG A BUCKY

W EXT XR ORDER

Absence of V2 power supply in the set mA and kV circuit

Error during the start time

The sum of the product-area doses have been reset

The Bucky key has been pressed but no potter is connected to the unit.

After waiting for a short time, no x-ray consent is arrived from the Potter Bucky.

Turn off, wait for some minutes, turn on and if the error appears again, call

Service

Press RESET to proceed and repeat exposure

F CHOPPER FAULT

F LACK OF X-RAY

F DATA ERR.

W MAN STOP XR

F INVERTER KV ERROR

F INVERTER OVERLOAD Inverter power out of range

F INVERTER FAULT

F TUBE CALIB. ERR.

Chopper error

The x-ray handswitch has been pressed at the 1 st

step for more than 15 secs. kV don't reach the 75% of the set value within the first 10ms of exposure or lack of xrays.

The max. exposure time has been achieved

(2s)

Memory error, data checksum error

IGBT drivers error

X-ray tube calibration error

Press RESET to proceed, repeat x-rays

Release the handswitch and repeat radiography

Press RESET to proceed and repeat exposure

Press RESET to proceed and repeat exposure

Turn off, wait for some minutes, turn on and if the error appears again, call

Service

The x-ray handswitch has been released

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 or the H.V. circuit has unbalanced during exposure

Press RESET and repeat exposure

Press RESET and proceed

Press RESET and proceed

F HAND SWITCH ERR

W DAP INACTIVE

Faulty x-ray handswitch

Call Service

Check the x-ray handswitch integrity, turn off and on again the unit, then try again.

If the error appears again, call Service

-

S

W

DAP READY

DAP ERROR

The dosimeter is not connected

The doses meter has reached the max.value that can be displayed

The dosimeter is ready

The dosimeter is connected, but in fault

Press F1+RESET to reset the value

-

Press RESET and call Service

-

Press RESET to proceed and connect a

Bucky.

Press RESET and call Service

Pag. 10/34- Rev.6

[File: AD3001_E00.doc]

Technix S.p.A.

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

TMS300 - User's Manual

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

Portuguese (PT)

ENG ITA FRE GER SPA POR

CLOCK OFF ERR.OROLOGIO ERR. HORLOGE

TAKTGEBER

DEFEKT

FALLO RELOJ ERRO RELOGIO

POWER FAULT

V3 FAULT

RESET APR

POTENZA GUASTA

ERRORE V3

INI.APR

ERR. BATTERIE

V3 DEFECT.

INI.APR

STROMVERSORG.

DEF

V3 DEFEKT

APR-DATEN

DEFEKT

FALLO ACUMUL.

FALLO V3

POTENCIA FALHA

ERRO V3

INI.APR INI.APR

APR OUT OF

RANGE

ERRORE IN APR ERREUR APR APR-WERT FALSCH FALLO APR ERRO APR

TUBE SEASONING FORM.DEL TUBO FORM. DU TUBE

ROEHRE

ENFAHREN

AJUSTE DEL TUBO

FORMACAO

TUBO

HOT TUBE

V2 FAULT

STARTER

INTERLOCK

CHOPPER FAULT

TUBO CALDO

ERRORE V2

STARTER

BLOCCATO

CHOPPER

GUASTO

TUBE CHAUD

ERREUR V2

BLOCAGE

DEMARREUR

HACHEUR

DEFECT.

ROEHRE HEISS

V2 DEFEKT

ANLAUF-FEHLER

TEMPER.

FALLO V2

BLOQUEO

CEBADOR

TUBO MORNO

ERRO V2

STARTER

OBSTRUIDO

TIME OUT TEMPO SCADUTO TEMPS EXPIRE PREP ZU LANG FUERA TIEMPO FORA TEMPO

READY PRONTO PRET BEREIT LISTO PRONTO

LACK OF X-RAY

MAX TIME

DATA ERR.

MAN STOP XR

INVERTER KV ERR.

INVERTER

OVERLOAD

INVERTER FAULT

ERRORE RAGGI

TEMPO MAX

ERR. DATI

STOP MANUALE

SOVRACCARICO

INV.

ERRORE INVERTER

ERREUR RX

TEMPS MAX

ERR. DONNÉE

ARRÊT UTILISAT.

ERR.KV INVERTER ERR.KV

SURCHARGE

CONVERT.

DEFAUT

CONVERT.

KEINE

STRAHLUNG

MAX EXP ERREICHT

DATEN-FEHLER

EXP

UNTERBROCHEN

WANDLER KV

FEHLER

WANDLER

UEBERLAST

WANDLER FEHLER

SIN RADIACION

TIEMPO MAX

FALLO DATO

INTERRUP.

MANUAL

ERRO RAIOS

TEMPO MAXIMO

ERRO DADOS

TERMINO

MANUAL

FALLO KV TRANSF ERRO KV INVERTER

SOBRECARGA

TRANSF

FALLO TRANSF

SOBRECARGA INV.

ERRO INVERTER

CALIB. TUBE ERR. ERR. CALIB.TUBO ERR. CALIBRAGE

ROEHRE

KALIBRIER.

FALLO CALIB. ERRO CALIB.TUBO

MANUAL MANUALE MANUEL MANUELL MANUAL MANUAL

HAND SWITCH

ERR

DAP READY

DAP INACTIVE

ERR.PULSANTE RX BOUTON DEFECT. HANDSCHALT.DEF

DAP PRONTO

DAP INATTIVO

DAP PRET

DAP INACTIF

DAP BEREIT

DAP INAKTIV

FALLO MANDO ERRO BOTAO RX

DAP LISTO DAP PRONTO

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

EXT XR ORDER NO RX ESTERNO EXT XR ORDRE

VERBINDEN

AUβENAMTRIEB

CONECT.BUCKY

NO BUCKY

LIGAR. BUCKY

NO RX FORA

[File: AD3001_E00.doc] Rev.6 - Pag. 11/34

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

Movements of the monobloc - collimator group

Figure 5

Safety knob

Figure 6

Parking position

Figure 7 pos.1: deactivated brake

Figure 8 pos.2: activated brake

Pag. 12/34- Rev.6

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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

[File: AD3001_E00.doc] Rev.4 - Pag. 13/34

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

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

Pag. 14/34- Rev.4

[File: AD3001_E00.doc]

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

4.4. Start up and checks at the ignition

1.

2.

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).

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

U N I T

V E R

N A M E

X . X X . X X with dosimeter

D A P X X X X X X X X

U N I T N A M E

V E R X . X X . X X

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

B U S Y

M A N U A L

6 3 4

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

R E A D Y

M A N U A 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

4.5. Exposures

Set the exposure data by following the operative procedure here below.

IGNITION & START UP

MANUAL MODE

R E A D Y

M A N U A L

6 3 4

Upon ignition the unit is in MANUAL MODE

Adjust the radiological parameters by pressing kV

+/- and mAs +/- keys.

Press the DOSE Key to enable / disable the Dose

Reduction function.

PRESS X-RAY HANDSWITCH TO

PERFORM EXPOSURES

Press RESET to return to MANUAL MODE

Press MENU to proceed to APR

MODE

ANATOMIC PROGRAMMED MODE (APR)

S K U L L / A B D OM E N 1 / 4

T h o r a x a p

S k u l l d

C e r v i c a l S p i n e

The first line shows the name of the exams group, the others show the 1 shift to the 2 nd st

page. page of the exams of that group.

Every group is composed by 6 exams, press MENU to

S K U L L / A B D OM E N 1 / 4 c L u m b a r S p i n e a p

A b d o m e n

P e l v i s a p a p

Press F1 to shift to the next group.

U P P E R E X T R E M I T .

S h o u l d e r a p

C l a v i c l e d

H u m e r u s / e l b o w

2 / 4

Technix S.p.A.

Press F2, F3 or F4 to select the proper program

Press F2 to return to

APR menu

Pag. 16/34- Rev.6

PROGRAM DISPLAY

R E A D Y

P E D I A T R I C S

I n f a n t L u n g 1 . 5 k g

6 0 0 . 4

1

2

4 st nd

3 rd th

line: reserved to messages

line: selected group

line: program name

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 (3 rd line).

In order to store the new values, it is necessary to press F3 and, by holding it down, press the

MENU Key.

[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.

Folder Part of Body

Thorax ap kV mAs

85 3.2

SC

[DIN]

1

200

Cartella Part of Body kV mAs SC [DIN] 1

1/4

SKULL /

ABDOMEN

Cervical Spine 66 6.3 400

3/4

LOWER

EXTREMITIES

Lower Leg 60 4.0 200

Lumbar Spine ap 78 6.3 400

Abdomen ap

Pelvis ap

85 5.0

77 3.2

400

400

2/4

UPPER

EXTREMITIES

Shoulder ap

Humerus/elbow 60 4.0 200

Hand ap

66 16.0

10.0

2.5

46 2.5

200

200

4/4

Added Filter

1mmAl +

0,2mmCu

2

Thorax 1.0 Kg

Thorax 2.0 Kg

Thorax 4.0 Kg

Thorax 6.0 Kg

Thorax 8.0 Kg

Thorax 10 Kg

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

60 0.2

62 0.4

72 0.4

74 0.4

76 0.4

400

400

400

400

400

76 0.63 400

APR Groups and Programs

English (GB)

Thorax ap

Italian (I)

Torace ap

French (F)

Thorax ap

German (D)

Thorax ap

Spanish (ES)

CRÁNEO/

ABDOMEN

Tórax ap

Portuguese (PT)

SKULL/ABDOMEN

Thorax ap

Cervical Spine

Lumbar Spine ap

Abdomen ap

Pelvis ap

UPPER EXTREMIT.

Shoulder ap

Spina Dorsale

Spina Lombare

Addome ap

Bacino ap

ESTREMITÁ SUP.

Spalla ap

Col.Cervical

Col.Lumbaire

Abdomen ap

Bassin ap

EXTREMITES SUP.

Epaule ap

HWS

LWS ap

Abdomen ap

Becken ap

OBERE EXTREMIT.

Schulter ap

Columna Cerv.

Columna Lumb.

Abdomen ap

Pelvis ap

Espinho Dorsal

Espinho Lumbar

Abdomen

Pelvis

EXTREM. SUPERIOR EXTREM.AVANCADA

Hombro Hombro

Humerus/elbow Omero/Gomito Humerus/Coude OA/Ellenbogen Húmero/Codo Omero/Cotovelo

Hand ap

LOWER EXTREMIT.

Mano ap

ESTREMITÁ INF.

Main ap

EXTREMITES INF.

Hand ap

UNTERE EXTREMIT.

Mano ap

EXTREM. INFERIOR

Mao ap

EXTREM.INFERIOR

Knee Ginocchio Genou Knie Rodilla Joelho

Lower Leg Gamba inf. Jamb inf. US Tibia/Peroné inferior

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

Thorax 4.0 Kg

Torace 2.0 Kg

Torace 4.0 Kg

Thorax 2.0 Kg

Thorax 4.0 Kg

Thorax 2.0 Kg

Thorax 4.0 Kg

Tórax 2.0 Kg

Tórax 4.0 Kg

Thorax 2.0 Kg

Thorax 4.0 Kg

Thorax 6.0 Kg

Thorax 8.0 Kg

Thorax 10 Kg

Torace 6.0 Kg

Torace 8.0 Kg

Torace 10 Kg

Thorax 6.0 Kg

Thorax 8.0 Kg

Thorax 10 Kg

Thorax 6.0 Kg

Thorax 8.0 Kg

Thorax 10 Kg

Tórax 6.0 Kg

Tórax 8.0 Kg

Tórax 10 Kg

Thorax 6.0 Kg

Thorax 8.0 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

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

Technix S.p.A.

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 Xray 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

(second step). Then there is a delay of about 1.2 s before the real exposure.

• Hold the x-ray control down till the exposure has been performed properly (3 beeps).

1° step “prep”

Figure 14

2° step “rad”

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 “1 st

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 the emission phase “rad”.

Lamp lighting-ON – For lighting ON the collimator lamp press the relative key, the lamp will light OFF after the lighting-ON time of 30sec.

Preparation phase “prep” – press and release the pushbutton “prep + rad”.

Emission phase “rad” – Press twice the x-ray push- button

“prep + rad” within 15sec. and hold it down till the 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.

LAMP

LOW

BATT

PREP +

RAD

Pag. 18/34- Rev.4

[File: AD3001_E00.doc]

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

• Only if the display shows the writing “READY” and the READY led is ON, it is possible to perform an exposure.

• The 1

• The 4 st th

line of the display shows the use messages and the error signals.

line of the display shows the radiological parameters.

• After every exposure, the 4 th 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 [cGgcm

2

] 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 [cGycm

2

]:

R E A D Y 0 0 0 0 . 0 0

R E A D Y c G y c m 2

The measures summation is the sum of all the dose-area products read by the chamber. By pressing

F1+RESET, the value resets. n

dose

i

⋅ area

i 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 0000,00cGycm 2 and 9999,99cGycm 2 . When the measures summation exceeds 9999,99cGycm

2

, 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

Born on ............... xxxx.xx cGycm2

Operator..............

Date

Birth date of the patient (*)

Dose to which the patient has been exposed (0000.00 cGycm2)

Operator’s signature (*)

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

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

Technix S.p.A.

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.

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.

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.

Daily:

Weekly:

Every 6 months:

Yearly:

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

Summary of the periodical checks

Check the functionality of alarms, displays and indicators.

Check the warning and danger labels integrity.

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

Check the brakes and the directional handle functionality.

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

Description

Voltage

Frequency

Absorbed current

Data

115/230Vac ±10% standard monophase with automatic unit prearrangement in function of the mains (plug & play).

50/60Hz standard

Values of current absorbed by the unit in the different operative conditions and in the two power supply values:

Operative condition

Charger On

Stand By

115 Vac / 50Hz 230 Vac / 50Hz

5,5 A

MAX

3,4A

0,87A

MAX

0,58A

Stand By + Collimator Lamp

Stand By + Charger On

Stand By + Collimator Lamp + Charger On

2,3A

5,1A

6,7A

1,5A

3,0A

3,8A

Preparation + Collimator Lamp

X-ray emission + Collimator Lamp

Line compensation

Automatic

Line resistance

<1 Ω @115/230Vac

Standard socket outlet

16A @230Vac

Isolation class

Use conditions

Class I with applied parts type B

Continuous functioning with intermitting load

5,5A

3A

PK

7,3A

3A

PK

The unit is not suitable to the use where danger of inflammable mixtures with air or nitrous oxide exists.

Description

User’s interface

Settable languages

Radiography control

Safeties

Data

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.

Italian, English, French, German, Spanish, Português, through configuration program

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.

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

Data

Working technique

APR technique

Exposure control

Dose

Small focus (IEC 60336)

Large focus (IEC 60336)

Generator power in DC current

Inverter frequency

Inverter frequency in high voltage

Max.ripple

Rise time kV range mA range @115/230Vac mAs range @115/230Vac

Times range @115/230Vac

Use coefficient (duty cycle)

Dati

2 points with kV and mAs setting

24 exams storage (4 folders each of 6 exams) available in the 5 different selectable languages.

Constant kV and mA during all the exposure

A 50% reduction (LD)

0,8mm

1,3mm

30kW@100kV

20kHz

40kHz

<2% @100kV,

(100kV,100ms, 300mA)

<2ms @100kV

40

÷ 125kV in step of 1kV

50 ÷ 300mA automatically associated to kV

0,2

÷ 220mAs steps with increases of 12,5%

0,002 ÷ 2,2s in function of the set mAs

1:40

Technix S.p.A. kV mA values @115/230Vac

Small focus Large focus

H.P.

(t<100ms)

L.P.

(t>100ms)

H.P.

(t<100ms)

L.P.

(t>100ms)

40 200mA 100mA 200mA 200mA

50 200mA 100mA 250mA 200mA

60 190mA 95mA 300mA 190mA

70 180mA 90mA 300mA 180mA

80 170mA 85mA 300mA 170mA

90 160mA 80mA 300mA 160mA

100 150mA 75mA 300mA 150mA

110 130mA 65mA 260mA 130mA

120 115mA 55mA 220mA 110mA

125 110mA 50mA 200mA 100mA mAs value in function of kV

@115/230Vac mAs (HD) mAs (LD) kV

0.2-220 0.2-110 40

0.2-200 0.2-100 41-45

0.2-180 0.2-90 46-52

0.2-160 0.2-80 53-62

0.2-140 0.2-70 63-72

0.2-110 0.2-55 73-92

0.2-100 0.2-50 93-112

0.2-90 0.2-45 113-125

Pag. 24/34- Rev.6

[File: AD3001_E00.doc]

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

Description

Temperature

Relative humidity

Pressure

Normal use

From +10°C to +40°C

From 30% to 75% non condensing

From 700 to 1060hPa

Transport and storage

From -25°C to +70°C

From 10% to 90% non condensing

From 500 to 1060hPa

Description

Weight

Max. width

Length in transport position

Max. height in transport position

Max. height with the arm at the max. extension

Control panel height

Focus-floor distance

Arm rotation around the vertical axis

Monobloc rotation around the arm axis

Monobloc rotation around its axis

Max. height of the front unit leg

Cassette holder

Movement

Wheels diameter

Data approx.185 Kg (408 Lb)

700mm (27,56in.)

1338mm (52,68in.)

1458mm (57,40in.)

2258mm (88,90in.)

1000mm (39,37in.)

456

÷ 2018mm (17,95 ÷ 79,45in.) n.a.

±180°

151° (+133° ÷ -18° in respect of the vertical axis)

105mm (4,13in.)

5 cassettes format 35 x 43cm (12x15in.)

Manual.

Double front swiveling wheel.

Parking brake

Handle for tilting (obstacles overcoming)

Rear: wheel Ø250mm (9,84in.) width 50mm (1,97in.)

Front: double wheel Ø 80mm (3,15in.) width 22mm (0,87in.)

[File: AD3001_E00.doc] Rev.4 - Pag. 25/34

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

Pag. 26/34- Rev.4

Figure 15

[File: AD3001_E00.doc]

Technix S.p.A.

6.6.1. Generator

Description

Inverter

Working frequency

Power supply

Dimensions

Max. absorbed current

Technology

Safeties

Generator power in constant DC current (IEC 601-1)

Max. voltage to the tube

Max. ripple at 100kVp

Rise time at 100kVp

Max. current in radiography

Dati

IHF 2030

20kHz max

680Vdc max

240x210x140 mm

9,45x8,27x5,51 in.

75A

IGBT overcurrent overvoltage

IGBT driver fault

30kW

(300mA @ 100kV per 0.1s)

125kVp

<2%

<2 ms

300mA

TMS300 - User's Manual

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

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

300

250

200

150

350

X-Ray Tube

Description

Type

Nominal anode power (IEC 613, EN 60613)

Nominal foci size (IEC 336, EN 60336)

Speed of rotation

Anode diameter

Anode material

Anode angle

Min. inherent filtration (IEC 522)

Thermal anode capacity

Max. continuous anode dissipation

Max. anode cooling speed

Nominal high-voltage

Max. filament current

Data

X22 0.8/1.3

16kW/32kW

0.8mm – 1.3 mm

2850 rpm @ 50Hz

64mm (2,52in.)

Tungsten

15°

0.7mmAl eq.

80kJ (107kHU)

300W

22kJ/min (29.5kHU/min)

130kV

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

70

800 W

500 W

300 W

60

200 W

50

40

100 W

30

20

10

0

0 5

Tempo - Time - Temps (min)

10

Figure 17 Figure 16

Single load curves

0.8 - 3~ - 3000min

-1

Anodic current (mA) / Exposure Time (s)

Single load curves

1.3 - 3~ - 3000min

-1

Anodic current (mA) / Exposure Time (s)

700

15

50 kV

60 kV

70 kV

80 kV

90 kV

100 kV

110 kV

120 kV

130 kV

600

500

400

300

200

50 kV

60 kV

70 kV

80 kV

90 kV

100 kV

110 kV

120 kV

130 kV

100

50

0

0.01

0.1

1

Tempo di esposizione - Time - Temps (sec)

Figure 18

10

100

0

0.01

0.1

1

Tempo di esposizione - Time - Temps (sec)

Figure 19

10

Pag. 28/34- Rev.4

[File: AD3001_E00.doc]

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

Monobloc

Description

Monobloc

Weight

Dimensions

X-ray tube

Anode

External thermostat

Thermal monobloc capacity

Max continuous thermal dissipation of monobloc

Max. monobloc anode cooling speed

Total filtration

Leakage radiation

Loading, heating and cooling curves

H.V. transformer insulation

Dimensions

Dati

MHF 2030

20kg (44,09Lb)

320x140x255mm (12,60x5,51x10,04in.)

X22 0.8/1.3

Rotating (2850rpm at 50Hz)(3400rpm at 60Hz)

57°

600kJ (800kHU)

55W

5,4kJ/min (7,2kHU/min)

1.1mm Al

<1mGy/h according to IEC 601-1-3

See the enclosed diagrams

Oil bath

Heating and cooling curves of monobloc

Stored energy (kJ) / Time (min)

Figure 20

Figure 21

[File: AD3001_E00.doc] Rev.4 - Pag. 29/34

User's Manual - TMS300

6.6.3. Collimator

Technix S.p.A.

Description

Type, brand and model

Collimator

Light source

Data

Manual with internal light source (Ralco R221)

Square field, multilayers

Halogen Lamp 12V 100W with timed switching-on at approx. 30s

X-ray field

Luminous intensity

Contrast ratio

Measurement of focus-film distance

Rotation

Weight

Sizes

Accessories

43x43cm (16,93x16,93in.) at 1m (39,37in.) DFF

160lux at 1m (39,37in.) DFF

4:1

Extractable meter

±115°

8,4kg (18,52Lb)

183x168x256mm (7,20x6,61x10,08in.)

Prearrangement to insert the dosimeter

Max protection against leaked radiation

(EN60601-1-3 par.29.204.3)

Indicator accuracy

(EN60601-1-3 par.29.202.8)

Inherent filtration

(EN60601-1-3 par.29.201.2/29.201.6)

Light field accuracy

(EN60601-1-3 par.29.202.9)

125kV 4mA

It corresponds to the x-ray fields with tolerance lower than

2% of used FFD

2.0mmAl eq.

It corresponds to the x-ray fields with tolerance lower than

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

Type, brand and model

Measurement unit

Resolution

Dose-area product summation range

Max. measuring range

Data

Dosimeter with ionization chamber, PTW-Freiburg

DIAMENTOR CI-P cGycm 2

0,01cGycm 2

0000,00 ÷ 9999,99 cGycm 2

118mm x 118mm (4,65x4,65in.)

6.6.5.

Printer for DAP (optional)

This device is installed only on request.

Description

Type

Printing method

Resolution

Printing speed

Paper width (mm)

Roll dimensions (mm)

Print area

Interface

Power Supply

Power consumption (print)

Temperature, Operatine, Storage

Humidity, Operating, Storage

Dimensions (WxDxH)

Weight

Safety

Data

S’Print-S

Thermal line printing

203dpi

>50mm/sec (it depends on the printing typology and the environment temperature)

58mm

57.5 ±1

48mm

RS-232

18±24VDC / 0,6A

925mA

0±50°C

-20±70°C, without paper roll

10±85%, without condensation

10±90%, without condensation, without paper roll

146 x 88 x 65mm

370gr (without paper roll

EN60950+A1+A2+A3+A4

Pag. 30/34- Rev.7

[File: AD3001_E00.doc]

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

Description

X-ray handswitch with extendible cable

Ionization chamber dosimeter, mod. DIAMENTOR CI-P

X-ray infrared remote control, mod. TECH SWITCH

Printer for dose meter, mod. S’Print-S

Hook for radio protective apron

Tilting pedal

6.8. Compliance with Directives and Technical Standards

Reference

MDD 93/42/EEC

IEC 60601-1

IEC 60601-1-2

IEC 60601-1-3

IEC 60601-1-8

IEC 60601-2-7

2nd edition

IEC 60601-2-28

IEC 60336

6.9. Labels and symbols

Standard

Optional

Optional

Optional

Optional

Optional

Description

Medical Devices Directive (CE mark)

Medical devices safety

Electromagnetic compatibility

Protection against ionizing radiation

General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

High voltage generators

Tube – housing groups

X-ray tubes focus

Figure 22

[File: AD3001_E00.doc] Rev.7 - Pag. 31/34

User's Manual - TMS300

Reference Figure 22

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

Technix S.p.A.

Pos.3. – Collimator label

Pos.5. – Equipotential Node label

Pos.7. – Braking indication label

Pos.4. – Potter Bucky label

Pos.6. – Tilting label

Pos.8. – WEEE label

Pag. 32/34- Rev.8

[File: AD3001_E00.doc]

Technix S.p.A.

Protective ground clamp

Dangerous voltage

TMS300 - User's Manual

Precautionary warning

Unit OFF

Unit ON

Ionizing radiation

Unit Type B

Total filtration

Alternate voltage

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

Selection of

HAND SWITCH –

CORDLESS mode

Large focus

Small focus

Fragile Protect from rain

Upper edge of the packing

[File: AD3001_E00.doc] Rev.4 - Pag. 33/34

User's Manual - TMS300

(This page is intentionally left blank)

Technix S.p.A.

Pag. 34/34- Rev.4

[File: AD3001_E00.doc]

Document status TMS300 – User's Manual

DOCUMENT STATUS

Rev. Date Pages Modification description

0 26.08.03 -

1 25-07-02

2 14-01-04

4-34

Updated paragraph “Applications & use destination”

Updated unit’s labels

All General

3 21.01.05 6, 18, 19, 30, 32 Introduction of the x-ray remote control accessory.

4 31.10.05

5 10/07/06 tutte

32

Introduced position of WEEE label.

Introduced explanation note of the WEEE symbol

(+repaging).

Updating of the unit labels and symbols.

Updating of the monobloc and unit labels according to the standards in force.

6 05/12/06

5, 6, 7, 8, 9,

10, 11, 12, 16,

17, 19, 23, 24, 30

Introduced the function of the half dose.

Introduced the new dose meter chamber, printer for dosimeter, tilting pedal, portuguese language on the display.

7 21/05/07 30,

Introduction of the technical data of the DAP printer and the 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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Key Features

  • Compact and maneuverable
  • Ergonomic design
  • Perfectly balanced monobloc arm
  • Wide range of clinical applications
  • Easy to transport
  • Accurate positioning
  • Excellent visibility

Frequently Answers and Questions

What are the proper steps to take when transporting the TMS300 Mobile X-ray System?
The unit must be OFF, the supply plug must be removed from the socket outlet and the cable wound. Place the monobloc - collimator group vertically and activate its rotation safety lock. Move downwards the arm by using the handles and by keeping in vertical position the monobloc-collimator group; when the parking position is reached rotate and engage the safety lock. Release the parking brake. 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.
How do I adjust the collimator on the TMS300 Mobile X-ray System?
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. It is possible to turn the lamp ON by pressing the COLLIMATOR push-button placed on the control panel. The extensible meter allows to measure with accuracy the focus-film distance (FFD). If necessary, rotate the collimator.
What are the different modes for performing an exposure on the TMS300 Mobile X-ray System?
The 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.

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