Trixell Pixium 4600 Manuale

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PIXIUM 4600 : Installation, Service, and Users manual

This manual describes the installation procedures and operation of the PIXIUM 4600 digital X-ray detector.

It also provides information for service and safety operation. It is intended for use by a system integrator.

Please read this manual carefully before performing any installation or use of a PIXIUM 4600 detector.

Document history

Index Date Author Nature of the modification

A 06 / 04 / 00 J. DUTIN Initial document

B 05 / 09 / 03 J. DUTIN Laser diode classification (DM 12 074)

Product evolution (DM 14 425)

C 30 / 10 / 03 P. SALQUE Accompanying documents evolution (DM 17029)

D 25 / 04 / 05 C. BOUCHET Acclimatization time regularization (DM 21908)

E 22 / 07 / 05 J. DUTIN Recycling label (DM 23669)

F 22 / 09 / 05 J. DUTIN Removal of CD-ROM (DM 22958)

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Table of contents

1PIXIUM 4600 PRESENTATION .......................................................................................................................... 4

1.1 GENERAL DESCRIPTION............................................................................................................................ 4

1.2 DELIVERY ..................................................................................................................................................... 4

1.3 DETECTOR .................................................................................................................................................... 4

1.4 IDENTIFICATION ......................................................................................................................................... 4

1.5 APPLICABLE STANDARDS :...................................................................................................................... 5

1.5.1 International Standards :............................................................................................................................ 5

1.5.2 European Directive : .................................................................................................................................. 5

1.5.3 National standards : ................................................................................................................................... 6

1.6 CERTIFICATIONS............................................................................................................................................... 6

1.7 GUIDANCE FOR MANUFACTURER'S DECLARATION .......................................................................................... 6

2PIXIUM 4600 TECHNICAL FEATURES ........................................................................................................... 7

2.1 MECHANICAL FEATURES ......................................................................................................................... 7

2.1.1 Dimensions and fixations............................................................................................................................ 7

2.1.2 Weight......................................................................................................................................................... 7

2.1.3 Input window .............................................................................................................................................. 7

2.2 ELECTRICAL FEATURES............................................................................................................................ 7

2.2.1 Power supply and mains synchronization input connector......................................................................... 7

2.2.2 Remote control and X-ray enable output connector ................................................................................... 8

2.2.3 Data transfer connector.............................................................................................................................. 9

2.2.4 Protective earth........................................................................................................................................... 9

2.3 SOFTWARE FEATURES............................................................................................................................. 10

2.4 OPERATION MODE - SYNCHRONIZATION........................................................................................... 10

2.5 ENVIRONMENTAL CONDITIONS ........................................................................................................... 10

2.6 ACCESSORIES ............................................................................................................................................ 11

3PIXIUM 4600 INSTALLATION ......................................................................................................................... 12

3.1 UNPACKING................................................................................................................................................ 12

3.2 COOLING ..................................................................................................................................................... 12

3.3 INSTALLATION .......................................................................................................................................... 12

3.4 CONNECTION ............................................................................................................................................. 13

4PIXIUM 4600 FIRST OPERATION................................................................................................................... 15

4.1 ADJUSTMENT............................................................................................................................................. 15

4.2 SWITCHING POWER ON ........................................................................................................................... 15

4.3 INITIALIZATION ........................................................................................................................................ 15

4.4 IMAGE ACQUISITION ............................................................................................................................... 15

5PIXIUM 4600 REGULAR OPERATION........................................................................................................... 16

5.1 RECOMMENDATIONS............................................................................................................................... 16

5.1.1 Temperature.............................................................................................................................................. 16

5.1.2 Cooling ..................................................................................................................................................... 16

5.1.3 EMC compliance....................................................................................................................................... 16

5.1.4 Warm-up time from a cold start................................................................................................................ 17

5.2 INTEGRATION ............................................................................................................................................ 17

5.2.1 Front protective label ............................................................................................................................... 17

5.2.2 Mechanical fixations : .............................................................................................................................. 17

5.3 X-RAY GENERATOR CONNECTION....................................................................................................... 17

5.4 CONFIGURATION AND UPGRADE......................................................................................................... 18

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5.5 CALIBRATION ................................................................................................................................................. 18

5.6 DETECTOR MODE SELECTION............................................................................................................... 19

6PIXIUM 4600 TROUBLESHOOTING............................................................................................................... 21

6.1 POWER SUPPLY RANGE ................................................................................................................................... 21

6.2 X-RAY ENABLE OUTPUT ................................................................................................................................. 21

6.3 INTERNAL TEMPERATURE ............................................................................................................................... 21

6.4 OTHER FAILURE.............................................................................................................................................. 21

7PIXIUM 4600 SERVICE...................................................................................................................................... 21

8PIXIUM 4600 CLEANING, STERILIZATION AND DISINFECTION INSTRUCTIONS.......................... 22

8.1 CLEANING ...................................................................................................................................................... 22

8.2 STERILIZATION AND DESINFECTION................................................................................................................ 22

9PIXIUM 4600 MANUFACTURER ..................................................................................................................... 22

10 APPENDIX B : IDENTIFICATION LABELS .................................................................................................. 23

Reference documents

Ref [1] PIXIUM 4600 General cautions and standards prescriptions

applying to system integration (document reference 61416485 – 108)

Ref [2] PIXIUM 4600 Storage, handling and packing instructions

(document reference 1001500 – 108)

Ref [3] PIXIUM 4600 Mechanical Interface Specification

(document reference 1000202 – 580)

Ref [4] PIXIUM 4600 Outline drawing

(document reference 1000015 – 041)

Ref [5] PIXIUM 4600 Software Interface Specification

(document reference 1000169 – 580)

Ref [6] PIXIUM 4600 Electrical Interface Specification

(document reference 1000201 – 580)

Warning

This manual is intended to help integrators in the installation of a PIXIUM 4600 detector and its

first operation. The figures and data given in this manual cannot be considered to be a contractual

specification. Consult TRIXELL for additional information.

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exclusive property. Any copy and/or disclosure thereof in any form whatsoever are subject to TRIXELL’s prior written consent.

1 PIXIUM 4600 PRESENTATION

1.1 GENERAL DESCRIPTION

The PIXIUM 4600 is a flat panel X-ray detector used for radiological applications, and is part of a

digital image acquisition of an overall Radiography System.

1.2 DELIVERY

The standard PIXIUM 4600 delivery includes :

• a detector,

• a CE compliance certificate,

• a print of the final test report,

• miscellaneous labels and cards according to customer specification,

1.3 DETECTOR

A E D B F

The detector consists of a metal housing with a carbon fiber composite window for X-ray input on

the upper side, and internal lead shielding against X-radiation.

It includes on one side (right side of the active sensitive array) :

• an input connector for the external power supply [A]

• a bi-directional RS-232 serial link connector for remote control [B]

• an output connector (optical link) for data transfer [C]

• two bolts : one to ground the detector [D] and the other to fasten the serial link cable in

order to provide cable strain relief [E]

• five LED indicators to display the state of the detector [F]

• identification and warning labels (refer to appendix B)

1.4 IDENTIFICATION

The identification labels on the right side of the detector housing provide information for :

• the type (PIXIUM 4600)

• the part number (P/N)

• the revision code (REV.)

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• the serial number (S/N)

• information for power supply connection

See appendix B for label models.

1.5 APPLICABLE STANDARDS :

1.5.1 International Standards :

Basic Safety Standard :

• IEC 601.1 2nd edition (1988), including amendment no 1 (1991) and amendment no 2

(1995) “Medical electrical equipment. Part 1: General requirements for safety” :

§ 5.1 : Pixium 4600 is a Class I equipment

§ 5.1 : Pixium 4600 has no applied part

§ 5.3 : Pixium 4600 has no specific protection against ingress of water

§ 5.4 : Pixium 4600 can be sterilized and disinfected (see the special corresponding section

in this document)

§ 5.5 : Pixium 4600 is not suitable for use in the presence of flammable mixtures

§ 5.6 : Pixium 4600 is designed to run in continuous operation

Collateral Safety Standards :

• IEC 601.1.2 2nd edition (2001-09), “Medical electrical equipment – General requirements

for safety – 2 – Collateral standard : Electromagnetic Compatibility – Requirements and

tests”

• IEC 601.1.3 1st edition (1994), “ Medical electrical equipment – General requirements for

safety – 3 – Collateral standard : Radiation Protection in Diagnostic X-Ray equipment”

• IEC 601.1.4 Edition 1.1(2000-04), “Medical electrical equipment – 4 – Collateral standard

: Programmable Electrical Medical Systems”

1.5.2 European Directive :

• Medical Device Directive MDD 93/42/EEC, of June 14, 1993, revision 398L0079 (Dec. 7,

1998) and 300L0070 (Dec. 13, 2000). Applies to all medical equipment except for active

implantable devices.

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1.5.3 National standards :

United States :

• UL 2601-1 “Medical electrical equipment. Part 1: General requirements for safety”; 2nd

edition, October 1997

• DHHS “Radiation protection (Code of Federal Regulations, title 21, Subchapter J, section

1020)"; revised version of April 1, 2002

Canada :

• CAN/CSA-C22.2 No. 601.1-M90 “Medical electrical equipment. Part 1: General

requirements for safety”; November 1990 + A1:1991 + A2:1995

E205430 / class PIDF2 and PIDF8

1.6 CERTIFICATIONS

The PIXIUM 4600 is certified and labeled as follow :

• UL : Combined UL/CSA certification (C-UL) label with following UL file reference :

E205430 / class PIDF2 and PIDF8

• CSA : Combined UL/CSA certification (C-UL) label (see above)

• CE : CE label

1.7 GUIDANCE FOR MANUFACTURER'S DECLARATION

Refer to accompanying document :

“General cautions and standards prescriptions applying to system integration”.

(document reference 61416485 – 108)

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2 PIXIUM 4600 TECHNICAL FEATURES

2.1 MECHANICAL FEATURES

2.1.1 Dimensions and fixations

Refer to outline drawing in Mechanical Interface Specification.

2.1.2 Weight

20 kg maximum (detector alone)

2.1.3 Input window

The X-ray input window (upper side of the detector) is made of a carbon fiber composite substrate,

to protect the sensitive layer and active array of the detector. This input window can withstand a

maximum pressure of 60 N/cm² over 2 cm² on the window center.

! ! ! CAUTION ! ! !

FRAGILE : Do not push on the upper face of the detector

! ! ! ATTENTION ! ! !

FRAGILE : Ne pas appuyer sur la face avant du détecteur

2.2 ELECTRICAL FEATURES

2.2.1 Power supply and mains synchronization input connector

Power supply Detector input voltage (nominal value) Input current (peak value)

+ 24V Vin low : + 23.7V / Vin high : + 25.3V 2A

+5V Vin low : + 5.0V / Vin high : + 5.2V 2A

-5V Vin low : - 5.2V / Vin high : - 5.0V 2A

Mains synchronization input : 50 or 60 Hz mains frequency internal synchronization for the detector

timing (trigger on the falling edge of a TTL compatible input signal). This link should be externally

opto-isolated to prevent ground loops in the detector connections. The detector input is an open-

collector schematics.

Connector type (detector side) : D-Sub / 9 contacts / male

Cable length : as short as possible.

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Connector pinout (see label on detector for pin locations):

PIN NUMBER

(9-pin connector)

FUNCTION

(3 power supplies with mains synchronization)

1 - 5 V Return (GND)

2 + 5 V Return (GND)

3 + 24 V Return (GND)

4 Mains synchronization signal

5 Mains synchronization signal return and shield (GND)

6 - 5 V

7 + 5 V

8 + 24 V

9 + 24 V

Housing Shield (GND)

2.2.2 Remote control and X-ray enable output connector

• Bi-directional RS-232C serial link for remote control of the detector with no hardware

handshake and transfer rate set to 9600 bds / even parity / 1 bit stop. This link should be

externally opto-isolated to prevent ground loops in the detector connections.

• Current loop (20mA) interface which can be used to enable the X-ray generator through an

optocoupler device.

• Connector type (detector side) : 6-pin mini-DIN female

• Connector pinout (receptacle) :

pin #1: TX Output pin #2 : XRAY-ENABLE +

pin #3 : GND pin #4 : +5V Output

pin #5 : RX Input pin #6 : XRAY-ENABLE -

Connector metal housing : shield (GND)

The pin #4 (labeled +5V) is a power supply output, available for external uses. The maximum

current available on this +5V pin is 100mA (@ 4.75V).

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2.2.3 Data transfer connector

Optical link transmission is used for image data output using 160 Mbits per second serial

asynchronous transmission (AMD Taxi protocol) on a fiber optic.

Fiber optic characteristic : multimode link with 62.5 / 125 µm fiber.

Connector type : ST II style

2.2.4 Protective earth

! ! ! CAUTION ! ! !

Connector and cable shields must not be used as Protective Earth connection.

! ! ! ATTENTION ! ! !

Le blindage des connecteurs et des câbles ne doit pas être utilisé pour mettre le détecteur à

la terre de protection.

Chassis grounding is carried out using an specific bolt on the side of the detector (see section 1.3

[D]). Used for Protective Earth connection of the detector.

! ! ! CAUTION ! ! !

The specific bolt must not be used for any other purpose than Protective Earth

connection. Removing this connection must need a service tool.

! ! ! ATTENTION ! ! !

Le goujon spécifique de mise à la masse ne doit pas être utilisé à d’autres fins que la

connexion de la terre de protection. La déconnexion nécessite un outil de maintenance.

For EMC reasons, there is no protective insulation between the electronics inside the detector and

the metal housing.

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2.3 SOFTWARE FEATURES

The detector is interfaced with the Radiographic System through programmation and control via a

serial link and a message protocol.

The detector can send to the System, upon request, messages containing the hardware and software

revision numbers, and the detector's serial number and date code.

The detector has built-in self-test features to provide the System with information for malfunction

diagnostic and preventive maintenance (see mode table).

The detector can generate, if enabled, error or warning messages in case of communication or

internal electronics malfunctions (such as internal voltages drifts or breakdowns). It is the System's

responsibility to decide what to do in case of such an error or warning.

The detector has built-in low-level routines that can be used by the System to perform image quality

tests.

The detector has a built-in set of test patterns that can be used to check the operation of the

detector's electronics (analog test patterns) and of the image data transmission (digital test patterns)

: see mode table and software interface specification.

If the detector has to reboot due to an internal error, it is able to come up to a normal operating

mode by itself.

2.4 OPERATION MODE - SYNCHRONIZATION

The internal detector timing is synchronized with an external signal connected to the Mains

synchronization input (see Power supply and mains synchronization input connector in section

2.2.1)

External synchronization period is 20 ms when operating on 50Hz mains frequency and 16.7 ms

when operating on 60 Hz mains frequency. The operation timing sequences remain the same

whatever the mains frame rate is.

2.5 ENVIRONMENTAL CONDITIONS

The transport and storage environmental conditions are (detector inside its original packing) :

- temperature range : - 25 °C to + 55 °C

- relative humidity : 10 % to 95 % R.H.

- pressure : 70 to 106 kPa

- shocks : 25 g , 6 ms , 150 shocks in X,Y,Z axis

- vibrations : 5-9 Hz , 3.5 mm / 9-500 Hz , 1 g / X,Y,Z axis

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