TRIXELL VPQ-EZ3NDTNFC pixium EZ3 NDT Portable X-Ray Detector User Manual

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pixium EZ3 NDT

Integration Manual and General Cautions

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DOCUMENT HISTORY

Version

DOORS

Baseline

Date

Author

Description

- draft 1

January 23

2025

O. Chastel

Initial version

330761

- draft 2

May 2

, 2025

O. Chastel

Update according to IEC 62368-1

Add Japan RF certificate

330761

- draft 3

September

, 2025

O. Chastel

Update mandatory text for FCC / IC declarations

Update main label

330761

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CONTENTS

Document History .............................................................................................................................................. 2

Contents ............................................................................................................................................................ 3

List of Tables ...................................................................................................................................................... 5

List of Figures .................................................................................................................................................... 6

1. PRESENTATION ........................................................................................................................................ 7

1.1. INTRODUCTION ............................................................................................................................... 7

1.2. GENERAL DESCRIPTION ................................................................................................................ 7

1.3. DETECTOR ....................................................................................................................................... 7

1.4. DELIVERY ......................................................................................................................................... 8

1.5. IDENTIFICATION............................................................................................................................... 8

1.6. STANDARDS ..................................................................................................................................... 8

1.7. REFERENCE DOCUMENTS ............................................................................................................ 9

1.8. DEFINITION, ACRONYMS, ABREVIATION ...................................................................................... 9

2. INSTALLATION.......................................................................................................................................... 11

2.1. INSTALLATION REQUIREMENTS ................................................................................................... 11

2.2. INSTALLATION PROCEDURE ......................................................................................................... 11

2.2.1. Mechanical installation .............................................................................................................. 11

2.2.2. Connectics ............................................................................................................................... 12

2.2.2.1. Connector unit .................................................................................................................. 12

2.2.2.2. Accessory connector ....................................................................................................... 13

2.2.2.3. Cable EZ3: Power supply ................................................................................................ 14

2.2.2.4. Cable EZ3: TDLP link ...................................................................................................... 15

2.2.2.5. Cable EZ3: Detector connector ....................................................................................... 16

2.2.3. X-ray generator connection ..................................................................................................... 17

2.2.4. Cooling ..................................................................................................................................... 17

2.2.5. Maximum allowed weight on the detector ............................................................................... 17

2.2.6. Detector settings ...................................................................................................................... 17

2.2.6.1. Communication link settings ............................................................................................ 18

2.2.6.2. Other settings ................................................................................................................... 18

2.2.7. Additonal accessories .............................................................................................................. 18

3. FIRST OPERATION ................................................................................................................................. 19

3.1. SWITCH ON .................................................................................................................................... 19

3.2. SWITCH OFF................................................................................................................................... 19

3.3. SOFTWARE FEATURES ................................................................................................................. 19

3.4. OPERATION MODES ...................................................................................................................... 19

3.4.1. Table mode definition ............................................................................................................... 19

3.4.2. Spatial relationship .................................................................................................................. 20

4. CAUTIONS AND RECOMMENDATIONS ................................................................................................ 21

4.1. SAFETY MEASURES FOR THE SYSTEM INTEGRATOR ............................................................ 21

4.1.1. Operation cautions ................................................................................................................... 21

4.2. CYBERSECURITY .......................................................................................................................... 21

4.3. TEMPERATURE .............................................................................................................................. 22

4.4. EMC COMPLIANCE ........................................................................................................................ 22

4.4.1. Cables and connectors ............................................................................................................ 22

4.5. WARM-UP TIME FROM A COLD START ........................................................................................ 22

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4.6. HUMIDITY........................................................................................................................................ 22

4.7. MAINTENANCE ............................................................................................................................... 23

4.8. SOFTWARE USE INFORMATIONS ................................................................................................ 23

5. TROUBLESHOOTING ............................................................................................................................. 24

5.1. POWER SUPPLY RANGE .............................................................................................................. 24

5.2. OTHER FAILURE ............................................................................................................................ 24

6. CLEANING AND DISINFECTIONS INSTRUCTIONS .............................................................................. 25

7. ECO-DESIGN ........................................................................................................................................... 27

7.1. RECYCLING/REFURBISHMENT .................................................................................................... 27

7.1.1. Battery ...................................................................................................................................... 27

7.1.2. Front End, backup cable and battery charger ......................................................................... 27

7.2. REACH INFORMATION (for Europe only) ...................................................................................... 27

8. MANUFACTURER.................................................................................................................................... 28

9. APPENDIX A: PIXIUM DETECTOR IDENTIFICATION LABELS ............................................................. 29

9.1. Labels .............................................................................................................................................. 29

9.1.1. Labels non CE marked by Trixell ..................................................... Erreur ! Signet non défini.

10. APPENDIX B: PIXIUM DETECTOR SUMMARY SHEET ........................................................................ 30

10.1. IMAGE GEOMETRY ........................................................................................................................ 30

10.2. ELECTRO-OPTICAL PERFORMANCES ........................................................................................ 30

10.3. ELECTRICAL INTERFACE ............................................................................................................. 30

10.4. MECHANICAL INTERFACE ............................................................................................................ 31

10.5. ENVIRONMENTAL CONDITIONS .................................................................................................. 31

10.5.1. TEMPERATURE ...................................................................................................................... 31

10.5.2. AIR PRESSURE ...................................................................................................................... 32

10.5.3. HUMIDITY ................................................................................................................................ 32

10.5.4. VIBRATIONS AND SHOCKS ................................................................................................... 32

11. APPENDIX D: RF certificates ................................................................................................................... 33

11.1. RED directive (Europe) .................................................................................................................... 33

11.2. FCC rules (U.S.A.) ........................................................................................................................... 35

11.3. IC (Canada) ..................................................................................................................................... 35

11.4. Other countries ................................................................................................................................ 36

12. APPENDIX E: RF communication ............................................................................................................ 37

12.1. RF features ...................................................................................................................................... 37

12.2. RF specifications ............................................................................................................................. 37

12.3. EIRP ................................................................................................................................................. 38

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LIST OF TABLES

Table 1: Reference documents .......................................................................................................................... 9

Table 2: Acronyms ........................................................................................................................................... 10

Table 3: Connector pin-out for connector unit ................................................................................................. 12

Table 4: Connection pin-out for Accessory connector ..................................................................................... 13

Table 6: Power supply connector pin-out ......................................................................................................... 14

Table 7: RJ45 connector pin-out ...................................................................................................................... 15

Table 8: Connector pin-out for backup cable ................................................................................................... 16

Table 9: Cleaning agent list ............................................................................................................................. 25

Table 11: European countries .......................................................................................................................... 33

Table 12: RF specifications .............................................................................................................................. 37

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LIST OF FIGURES

Figure 1: Top view (sensitive side) .................................................................................................................... 7

Figure 2: Bottom view (battery side) .................................................................................................................. 8

Figure 3: Backup cable connector ................................................................................................................... 12

Figure 4: Accessory connector ........................................................................................................................ 13

Figure 6: Power supply connector ................................................................................................................... 14

Figure 7: RJ45 connector ................................................................................................................................ 15

Figure 8: Backup cable connector ................................................................................................................... 16

Figure 9: Spatial relationship ........................................................................................................................... 20

Figure 10: Identification label ........................................................................................................................... 29

Figure 11: pixium 2430 EZ3 NDT main label ................................................................................................... 29

Figure 12: pixium 3543 EZ3 NDT main label ................................................................................................... 29

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1. PRESENTATION

1.1. INTRODUCTION

This manual describes the installation and operation of a pixium EZ3 NDT 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 EZ3 NDT detector.

This manual is intended to help integrators in the installation of a pixium EZ3 NDT detector and its first

operation. The figures and data given in this manual shall be considered as indicative and are not contractual.

Consult TRIXELL for additional information.

1.2. GENERAL DESCRIPTION

pixium EZ3 NDT detector is a part of a digital image acquisition chain in an overall Radiological System. It

features a portable equipment designed for mobile applications.

pixium EZ3 NDT detector complies with ISO 4090 standard for the external dimensions.

1.3. DETECTOR

The detector consists of a complete carbon fibre housing. They integrate:

 LEDs indicators for internal status,

 NFC module for pairing with host system,

 ON / OFF button,

 Display,

 Connector for a dedicated cable,

 Specific connector for power supply / Ethernet link

 A removable battery,

 Identification, warning labels and RF certificate ID (refer to appendix A for label drawings).

It does not include internal lead shielding against X-rays.

pixium 3543 EZ3 NDT

Figure 1: Top view (sensitive side)

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pixium 3543 EZ3 NDT

Figure 2: Bottom view (battery side)

Please note that the overfilm (color and printing) could be customized by customers on request.

1.4. DELIVERY

The standard pixium EZ3 NDT delivery includes:

 the detector,

 one backup cable(Cable EZ3),

 one battery (Battery EZ X),

 one battery charger (Charger EZ X),

 accompanying documentation.

Note that each customer may have a specific configuration for delivery.

The standard pixium EZ3 NDT delivery does not include in particular:

 an external power supply (part of the customer System),

1.5. IDENTIFICATION

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

 type (pixium EZ3 NDT)

 part number (P/N)

 revision code (Rev.)

 serial number (S/N)

 manufacturing date

 connections (power supply inputs / communication links)

 various warnings and cautions

See appendix A for label models.

1.6. STANDARDS

The pixium EZ3 NDT is:

 a class B product according to EN 55011 standard

The pixium EZ3 NDT is labeled as follow:

 CE

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1.7. REFERENCE DOCUMENTS

Bookmark

Document title

Reference

CTD

[EUM]

End User Manual

63150984

108

[PTS]

Product Technical Specification

63139627

306

[PSS]

Product Standard Specification

63139630

306

[MIS]

Mechnical Interface Specification

63139629

306

[EIS]

Electrical Interface Specification

63139138

306

[UCS]

Use Case Specification

63xxxxxx

306

[AID]

Application Interface Definition

63139620

108

[OUT_DRW]

Outline drawing

3543: 63140988

041

[DISM_DRW]

Dismantling drawing

63xxxxxx

066

[SCC]

Standard Compliance Certificate

3543: 63xxxxxx

600

[BATT_USR]

Battery EZ X user manual

63127737

108

[CHG_USR]

Charger EZ X user manual

63132829

108

[P3543_STR]

Unpacking instructions

62756802

108

Table 1: Reference documents

Note: Be sure to use the latest revision of these documents

1.8. DEFINITION, ACRONYMS, ABREVIATION

The following table presents the acronyms that may be used in this document:

Acronyms

Definition

CCK

Complementary Code Keying

ADC

Analog to Digital Converter

Conformité Européenne (meaning European Conformity)

COA

Condition Of Acceptability

Direct Current

EIRP

Equivalent Isotropically Radiated Power

EMC

Electro Magnetic Compatibility

ESD

Electro-Static Discharge

FCC

Federal Communications Commission

IEC

International Electro-technical Committee

ISO

International Standard Organization

ISM

Industrial, Scientific and Medical

LED

Light Emitting Diode

OFDM

Orthogonal Frequency-Division Multiplexing

Protective Earth

Radio Frequency

SIRN

Software Integration Release Note

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Acronyms

Definition

TBD

To Be Defined

TDLP

Trixell Detector Link Protocol

Table 2: Acronyms

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2. INSTALLATION

2.1. INSTALLATION REQUIREMENTS

Components needed for installation and operation are the following:

 One pixium EZ3 NDT detector

 One Charger EZ X (including its external power supply)

 One Battery EZ X

 One external single DC power supply (+12V) (not provided)

 One access point (not provided)

During installation, ensure that neither a sharp corner nor edge can damage the cabling.

Mechanical fixation of cables and connectors must be provided in order to prevent unnecessary wear out of

the cables.

2.2. INSTALLATION PROCEDURE

Please follow the below instructions before switching on the detector:

 Remove detector from its original packaging. Refer to [P3543_STR] for unpacking instructions.

 In case a power supply is available, compliant with [EIS] requirement, power connector of the Cable

EZ3 shall be plugged to this power supply.

 If a charged battery is available, it can be plugged into the detector on its backside, instead to use

the cable for power.

 Battery EZ X delivered in its original packaging can be plugged directly into the detector.

 Ethernet connector of the Cable EZ3 shall be plugged to network interface provided by the system

and the power connector shall be connected to external power supply provided by the system

 Then the magnetic connector of the cable can be plugged to the detector. There are two possible

orientations to plug this cable: both orientations can be used for proper operation.

 System shall be compatible with following default values of the detector for network compatibility:

o host IP address : 192.168.1.5

 If this is not the case, user shall use the infra-red link or NFC to set correct network configuration to

the detector.

 Configure the access point with the correct country code (please refer to user manual of access

point)

 First operation shall be done either by cable or infra-red. Wi-Fi settings (Wi-Fi SSID, Wi-Fi password)

shall be performed through System interface during this first operation.

2.2.1. MECHANICAL INSTALLATION

pixium EZ3 NDT is compatible with ISO 4090 cassette holder size

Constraints: pixium EZ3 NDT is qualified to be exposed to variations of accelerations refer to Appendix B

environmental conditions section. The detector can’t be used with non-natural variations of pressure.

Tightness: pixium EZ3 NDT (alone as well as with the battery connected) has a degree of protection against

ingress of water of IP 65 / 67 according to IEC 60529.

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2.2.2. CONNECTICS

2.2.2.1. Connector unit

Figure 3: Backup cable connector

Pin number

Signal

GND_SHIELD

TXRXP_B

TXRXM_A

P12V

GND

P12V

TXRXM_B

TXRXP_A

GND_SHIELD

TXRXP_C

TXRXM_D

TXRXM_C

TXRXP_D

GND_SHIELD

Table 3: Connector pin-out for connector unit

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2.2.2.2. Accessory connector

pixium EZ3 NDT includes an accessory connector for specific features as external AEC or external trigger

switch:

Figure 4: Accessory connector

Pin number

Signal

Comment

DEADMAN_SW

5VDC

RS232-TXD

RS232-RXD

GND

XR_ON

Maximum voltage: 5 V

Table 4: Connection pin-out for Accessory connector

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2.2.2.3. Cable EZ3: Power supply

Backup cable contains a double insulated connector on system side for power supply (connector reference

given in [EIS] document):

Figure 5: Power supply connector

Pin number

Signal

P12V

GND

Table 5: Power supply connector pin-out

- CAUTION -

Power supply polarity inversion or out of range power supply (including a missing power

supply) may harm the detector.

Be sure to correctly connect and clamp the power supply cable and the connector.

Check the power supply polarity before switching on. There is no hazard resulting from

switching on and off the power supply.

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2.2.2.4. Cable EZ3: TDLP link

Cable EZ3 contains a RJ45 connector on system side:

Figure 6: RJ45 connector

Pin number

Signal

TXRXP_A

TXRXM_A

TXRXP_B

TXRXP_C

TXRXM_C

TXRXM_B

TXRXP_D

TXRXM_D

Table 6: RJ45 connector pin-out

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2.2.2.5. Cable EZ3: Detector connector

A connector is accessible on the left side of the detector housing, in order to connect a cable from the System.

The purpose is to recharge the battery when discharged and to allow going on with image acquisition.

The attachment of the cable to the detector can be done in two orientations (rotation of 180° is allowed without

impact on the connection).

When the cable is attached on System side and connected to the detector, the Wi-Fi operation is disabled and

data transfer is managed through this cable (Ethernet link). The cable can be “hot-plugged”, meaning it can be

plugged and unplugged at any time without special precaution.

Figure 7: Backup cable connector

Pin number

Signal

GND_SHIELD

TXRXP_B

TXRXM_A

P12V

GND

P12V

TXRXM_B

TXRXP_A

GND_SHIELD

TXRXP_C

TXRXM_D

TXRXM_C

TXRXP_D

GND_SHIELD

Table 7: Connector pin-out for backup cable

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Note that Cable EZ is compatible with pixium EZ3 NDT. Nevertheless, the data rate will be reduced to

100Mb/s.

2.2.3. X-RAY GENERATOR CONNECTION

X-Ray source: The emission of the ionizing radiation is controlled by the system manufacturer.

- CAUTION -

X-ray Enable signal only indicates to the System that the detector is ready to receive X-rays.

It’s the System responsibility to control the actual emission of X-rays.

System accompanying documents must indicate:

 Procedure for X-ray alignment measurement

 Prohibition to order any radiation when a dysfunction is noticed by the operator, whatever this

dysfunction

2.2.4. COOLING

pixium EZ3 NDT detector has a passive cooling concept.

Thermal interface resistance is defined in §10.4.

2.2.5. MAXIMUM ALLOWED WEIGHT ON THE DETECTOR

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

the sensitive layer and active array of the detector.

This input window can withstand maximum weight without any image artefact:

PUID

Description

Product

Min

Value

Max

Unit

[PTS-REQ-1680]

PTS_perf_weight

The detector shall remain at full

performance for:

3543EZ3,

4343EZ3,

2430EZ3

 A mechanical weight uniformly

distributed over the complete surface

of:

3543EZ3,

4343EZ3,

2430EZ3

150

 A mechanical weight uniformly

distributed over the surface of a 4 cm

diameter disc of:

3543EZ3,

4343EZ3,

2430EZ3

100

This input window can withstand maximum weight without any irreversible degradation:

PUID

Description

Product

Min

Value

Max

Unit

[PTS-REQ-1670]

PTS_func_weight

The detector shall remain functional

for:

3543EZ3,

4343EZ3,

2430EZ3

 A mechanical weight uniformly

distributed over the complete surface

of:

3543EZ3,

4343EZ3,

2430EZ3

300

 A mechanical weight uniformly

distributed over the surface of a 4 cm

diameter disc of:

3543EZ3,

4343EZ3,

2430EZ3

100

2.2.6. DETECTOR SETTINGS

Initial detector settings are performed at the factory. Please refer to System Integrator installation procedure

for eventual image quality optimization.

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2.2.6.1. Communication link settings

For Wifi configuration and Ethernet configuration, please refer to §2.2

2.2.6.2. Other settings

Not applicable

2.2.7. ADDITONAL ACCESSORIES

Spare battery is available upon request. Refer to Battery EZ X documentation for additional information.

Spare backup cable is available upon request.

No anti-scattered grid is delivered with the detector.

In some mode of operation, an automatic exposure control device can be used. This device is not part of the

detector; it must be supplied and installed by the System integrator.

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3. FIRST OPERATION

3.1. SWITCH ON

Push the ON/OFF button to powered on the detector

3.2. SWITCH OFF

Push the ON/OFF button to powered off the detector.

Detector can also be stopped by a specific software command: refer to System information.

3.3. SOFTWARE FEATURES

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.

The detector can generate, upon request issued by the System, error or warning messages in case of

communication or internal electronics malfunctions (such as internal voltage 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 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): refer to mode table.

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

3.4. OPERATION MODES

For information about available operationnal modes please refer to mode table in [PTS].

3.4.1. TABLE MODE DEFINITION

The table mode is given in a separate document called SIRN provided to system integrator with each software

version. Please refer to the SIRN before integrating a new software.

- CAUTION -

Modes that are not described in the SIRN are TRIXELL reserved.

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3.4.2. SPATIAL RELATIONSHIP

The relationship between the physical detectors and the corresponding images issued from an acquisition are

as follow:

Figure 8: Spatial relationship

Top

Bottom

Left

Right

Bottom

Left

Right

Top

Mapix side

Thalassa

side

x (image)

y (image)

Mapix side

Thalassa

side

x (image)

y (image)

Mapix side

Thalassa side

x (image)

y (image)

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4. CAUTIONS AND RECOMMENDATIONS

4.1. SAFETY MEASURES FOR THE SYSTEM INTEGRATOR

4.1.1. OPERATION CAUTIONS

- CAUTION -

If pixium EZ3 NDT is modified, appropriate inspection and testing must be conducted to

ensure continued safe use of the equipment.

Software cautions:

 WiFi environment is complex and actual WiFi performances depend on local environment and

installation. The System Integrator is responsible for the WiFi level of service.

 The system integrator is responsible for battery management and powering the detector. The system

ensures that the detector is always powered during image cycle from the request image acquisition

to end of image storage or transmission, otherwise current image is lost.

 The system integrator shall strictly follow the instruction given in the information files when a new

software version has been released.

 The system integrator is responsible for managing the health check at detector startup. He must check

the detector health using the BIST features.

 The system integrator must check that Hotswap is Available before doing any action with the battery

(i.e.: changing the battery)

4.2. CYBERSECURITY

Pixium detector was developed taking into account Cyber Security constraints. The methodology for Trixell

risk analysis is based on EBIOS and is compliant to ISO27K5.

Note: pixium EZ3 NDT detectors exists in two different SW versions:

 Legacy version based on SIS

 A secured version based on DDS

For legacy constraints, not all risk mitigations have been implemented in the SIS version.

System integrator and end customer shall put special care to limit non-authorized access to the detector. In

particular, the detector should be stored in a restricted area in order to avoid stealing or unauthorized access

to the detector.

Users shall take special care on WiFi password management:

 It is recommended to change the default WiFi password before first installation and on a frequent basis

(at least every 90 days)

 A strong complexity/entropy should be put in place (at least 12 characters, at least one number and at

least one none alpha numeric character)

 System should keep at least the last 3 passwords in memory. User should use different password.

It is recommended to have a second spare battery available in order to avoid impact regarding image

acquisition, and transfer.

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4.3. TEMPERATURE

The Battery EZ X includes a thermal protection that shuts down the battery power in case of very high

temperature causing the Front End unusable. Two situations can occur:

 Software protection: the battery pack will be usable as soon as the temperature drops below a

specified limit,

 Hardware protection: the battery pack must be exchanged.

For more information about overheating protection please refer to [PTS] and [SIS] documents.

4.4. EMC COMPLIANCE

Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into

service according to the EMC information.

- CAUTION -

The use of accessories, transducers and cables other than those specified may result in

increased emissions or decreased immunity of the equipment.

- CAUTION -

The detector should not be used adjacent to or stacked with other equipment and if

adjacent or stacked use is necessary, the operability of the detector must be tested in the

modified configuration.

For more information about electromagnetic compatibility, please refer to appendix D .

4.4.1. CABLES AND CONNECTORS

The system integrator must take care with the kind of cables used to connect the pixium to the system :

TRIXELL recommends using a shielded power supply cable. The shielding must be properly connected to the

dedicated connector metallic body in order to insure a good electrical connection. The EMC conformity of the

detector was checked with 360° shielded cables.

4.5. WARM-UP TIME FROM A COLD START

Specification

Product

Description

Min

Value

Max

Unit

[PTS-REQ-0280]

PTS_cold_start_tim

e_single

In single mode, the cold start time (time to

reach full image performance) is:

4.6. HUMIDITY

Operating humidity:

The operating humidity is valid within the operating temperature range. However customer shall ensure that

detector is never submitted to condensation.

Customer shall take care that NO CONDENSATION occurs on the detector surface.

Storage humidity:

If detector is shipped mounted on the System to final customer: it is the responsibility of customer to ensure

that detector is never exposed to condensation.

See Appendix B for environmental conditions.

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4.7. MAINTENANCE

No other preventive maintenance action is required except the calibration needed for image quality, whose

periodicity is defined by the System program.

The battery can be replaced due to limited lifetime. In case of malfunction, the detector will be returned as it is

to the manufacturer for repair. However, possible software release can be realized using the control link:

contact TRIXELL customer service for instructions.

For maintenance please refer to system integrator maintenance manual.

4.8. SOFTWARE USE INFORMATIONS

When detector is powered on, the system must check the result of the pixium EZ3 NDT internal self-tests.

During operation, TRIXELL recommends the system to check:

 the header of every image sent by the detector,

 if possible, the internal temperature,

 the level of battery when powered by Battery EZ X,

 the WiFi link quality before requesting an image during free-cassette mode,

 the status of the anti-scatter grid (presence and type) thanks to dedicated command.

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5. TROUBLESHOOTING

5.1. POWER SUPPLY RANGE

During boot-up sequence, if the power supply fails out of the specified range, the detector might turn to a “Not

available” status and will not go to normal operation (no image generated).

When connected to an external power (backup cable), if power supply output is too low or too high, the detector

will not boot-up at all. Check your power supply to restart operation.

5.2. OTHER FAILURE

A “Not Available” status can also be issued by self-test functions, in case of internal failure on the electronic

board (firmware error, memory failure...).

After verifying that power supply range and internal temperature are correct, and if the detector is still issuing

a “Not Available” status, please contact Trixell field service.

If detector is not operational after reboot, Trixell recommends to retrieve error buffer through software

command to get more information about last error. To do this, a communication link with system is mandatory

(backup cable or wireless). See [AID] for detail.

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6. CLEANING AND DISINFECTIONS INSTRUCTIONS

The detector housing can be cleaned using a sweet towel, with respect to ESD safety conditions. Note that

the detector has a degree of protection against ingress of water of IP 67 according to IEC 60529.

The sterilization, disinfecting, and cleaning conditions are defined by the customer in the context of the System

use.

List of cleaning agents

#1 Metrex Caviwipes

#2 Schuelke Perform

#3 Bode Mikrobac tissues

#4 Ecolab Incidin plus

#5 Anios Surfa'safe

#6 PDI Sani-Cloth Active

#7 PDI Sani-Cloth Plus

#8 Virox / Diversey AccelTB

#9 Isopropyl alcohol

#10 Ethanol 70 %

#101 Clorox - Dispatch towels with bleach

#102 Clorox - Hydrogen peroxide

#104 - Freshening Industries - Hospicare 70

#105 - Freshening Industries - Hospicare Multi-Surface 60R

#106 - PDI - Sani-Cloth Prime

#107 - Tristel - Duo-wipes + ULT

Table 8: Cleaning agent list

In addition to this list, the external film is known to be free of any cosmetic degradation when exposed to the

following liquids:

 #F01 Metrex Caviwipes XL

 #F02 Schuelke Mikrozid sensitive wipes

 #F03 Schuelke Terralin protect

 #F04 Schuelke Mikrozid AF wipes

 #F05 Schuelke Mikrozid PAA wipes

 #F06 Bode Bacillol 30 Tissues

 #F07 Bode Dismozon plus

 #F08 Bode Bacillol AF

 #F09 Bode Mikrobac forte

 #F10 Ecolab Incidin pro

 #F11 Ecolab Incidin active

 #F12 Anios Surfanios premium

 #F13 Dr Schumacher Biguanid Flache

 #F14 Dr Schumacher Cleanisept (wipes 7.5% from liquid)

 #F15 Lysoform Lysoformin 3000

 #F16 Lysoform Clorina

 #F17 BBraun Meliseptol Rapid

 #F18 PDI Sani-Cloth AF3

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 #F19 PDI Sani-Cloth Super

 #F20 PDI Sani-Cloth Bleach

 #F21 Clorox Bleach germicidal wipes

 #F22 Diversey - sealed air Accel Five TB Wipes

Battery EZ X is considered as a part of the Front End, so same list of liquids applies.

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7. ECO-DESIGN

7.1. RECYCLING/REFURBISHMENT

Refer to pixium detector End Of Life datasheet (available on demand) for information about detector recycling

and refurbishment.

7.1.1. BATTERY

The end user must be clearly informed that battery packs Battery EZ X used in pixium EZ3 NDT contain

hazardous substances for the environment and must take all preventive actions to manage the battery end of

life (recycling plan).

7.1.2. FRONT END, BACKUP CABLE AND BATTERY CHARGER

TRIXELL is in charge of the recycling of pixium EZ3 NDT and their accessories (Cable EZ3 and Charger EZ

X). TRIXELL’s customers are in charge of managing the way to collect these products (end of their life or out

of order) and ship them to TRIXELL for recycling.

Information:

 pixium EZ3 NDT contains Thallium-doped Cesium Iodide scintillator material (Thallium qty < 2 g)

 pixium EZ3 NDT contains one or more lead plates of several sizes

TRIXELL expects its customers to take care of the recycling of the pixium EZ3 NDT within the framework of

the System recycling procedure.

7.2. REACH INFORMATION (FOR EUROPE ONLY)

Information on declarable substances are given in BOMcheck website (http://bomcheck.net/) accessible by

our direct customers.

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8. MANUFACTURER

pixium EZ3 NDT is manufactured by:

THALES AVS FRANCE SAS

460, rue du Pommarin

38430 MOIRANS FRANCE

Contact your local representative for additional information.

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9. APPENDIX A: PIXIUM DETECTOR IDENTIFICATION LABELS

9.1. LABELS

The labels presented below are not contractual and done for information

Figure 9: Identification label

TBD

Figure 10: pixium 2430 EZ3 NDT main label

Figure 11: pixium 3543 EZ3 NDT main label

Note that empty zone is reserved for RF certificate ID. Location of logos may slightly differ on the product.

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10. APPENDIX B: PIXIUM DETECTOR SUMMARY SHEET

10.1. IMAGE GEOMETRY

Transmitted image size:

Specification

Product

Description

Min

Value

Max

Unit

[PTS-REQ-0740]

PTS_transmitted_im

g_h

2430

Width:

2336

pel

3543

Width:

3520

pel

4343

Width:

4320

pel

[PTS-REQ-0750]

PTS_transmitted_im

g_v

2430

Height:

2880

pel

3543

Height:

4316

pel

4343

Height:

4316

pel

Pitch size:

Specification

Product

Description

Min

Value

Max

Unit

[PTS-REQ-0760]

PTS_pitch

Pitch:

98.75

µm

10.2. ELECTRO-OPTICAL PERFORMANCES

X-ray tube peak range:

Specification

Product

Description

Min

Value

Max

Unit

[PTS-REQ-1130]

PTS_x_ray_range_k

The X-ray tube peak voltage range is:

150

kVp

Angle between the X-ray central propagation axis and the normal axis of the entrance plane:

Specification

Product

Description

Min

Value

Max

Unit

[PTS-REQ-1110]

PTS_x_ray_angle

The angle between the X-ray central

propagation axis and the normal axis of the

front-end entrance plane - taken at the center

point of the matrix - should remain within the

following range:

-45

10.3. ELECTRICAL INTERFACE

Main ADC characteristics:

Specification

Product

Description

Min

Value

Max

Unit

[PTS-REQ-0810]

PTS_quantization_d

epth

The quantization depth of the digitized image

data signals is equal to (independently of

possible modes):

bits

Input voltage on connector unit :

Specification

Product

Description

Min

Value

Max

Unit

[EIS-REQ-0510]

EIS_pwr_input_volt

age_V

DC input power supply voltage shall be in the

following range:

10.8

13.2

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Input current on connector unit:

Specification

Product

Description

Min

Value

Max

Unit

[EIS-REQ-0040]

EIS_pwr_input_curr

ent_A

Typical and maximum sustained current in

mode 1, gain 4, image readout.

0.5

[EIS-REQ-0070]

EIS_pwr_input_inru

sh_A

Maximum peak current (at power ON or

during image acquisition) shall be lower than:

3.5

Thus, power supply must be conform to class PS1 (limited to 15 W max).

10.4. MECHANICAL INTERFACE

Information provided in Outline Drawing [OUT_DRW]

Specification

Product

Description

Min

Value

Max

Unit

[MIS-REQ-0250]

MIS_thermal

interface_resistance

The maximum thermal resistance (Rh) shall

be:

0.7

°C/W

10.5. ENVIRONMENTAL CONDITIONS

10.5.1. TEMPERATURE

Storage temperature range:

Specification

Product

Description

Min

Value

Max

Unit

[PTS-REQ-1220]

PTS_storage_packe

d_temperature

Ambient air temperature variation that can be

withstood by the detector during storage &

transport without any damage. Provision

shall be taken to avoid any condensing inside

the detector.

-10

+55

°C

Functional and operational (IQ) temperature range:

Specification

Product

Description

Min

Value

Max

Unit

[PTS-REQ-1570]

PTS_temperature_o

perational

The operational temperature range: is the

ambient temperature range where the

detector performances, reliability and image

quality are guaranteed within the

specifications. All the components shall

respect their temperature specification in

order to insure the reliability performance of

the product. The accessible parts

temperature limitations shall be respected.

+10

+25

+35

°C

[PTS-REQ-1600]

PTS_temperature_f

unctional

The functional temperature range: is the

ambient temperature range where the

detector functionality is guaranteed but not

the full image quality. All the components

shall respect their temperature specification.

-20

+50

°C

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10.5.2. AIR PRESSURE

Air pressure range on packed detector:

Specification

Product

Description

Min

Value

Max

Unit

[PTS-REQ-1260]

PTS_storage_packe

d_pressure

The detector can be stored and transported

under following pressure conditions:

500

1100

mbar

Air pressure range for operational performances (IQ):

Specification

Product

Description

Min

Value

Max

Unit

[PTS-REQ-1640]

PTS_pressure_rang

e_operational

The functional and performance operating

conditions for air pressure are:

700

1000

1100

mbar

[PTS-REQ-1650]

PTS_dist_calib_pre

ssure

The reference restrictions for distance to

calibration conditions for air pressure are:

-50

+50

mbar

10.5.3. HUMIDITY

Humidity range when pixium detector is packed:

Specification

Product

Description

Min

Value

Max

Unit

[PTS-REQ-1240]

PTS_storage_packe

d_humidity

The packed detector can be stored and

transported without any damage in the

following humidity range:

(Provision shall be taken to avoid any

condensing inside the detector.)

%HR

Operational and functional humidity range:

Specification

Product

Description

Min

Value

Max

Unit

[PTS-REQ-1620]

PTS_humidity_rang

e_operational

The functional and performance operating

conditions for relative humidity (non

condensing) for a temperature up to 40°C

are:

%HR

[PTS-REQ-1620]

PTS_humidity_rang

e_operational

The functional and performance operating

conditions for relative humidity (non

condensing) for a temperature up to 35°C

are:

%HR

10.5.4. VIBRATIONS AND SHOCKS

Vibrations and shock on unpacked detector:

Specification

Product

Description

Min

Value

Max

Unit

[PTS-REQ-1280]

PTS_storage_unpac

ked_shocks

In the unpacked case, the parameters of the

test are:

[PTS-REQ-1320]

PTS_storage_unpac

ked_vibrations

In the unpacked case, the parameters of the

test are:

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11. APPENDIX D: RF CERTIFICATES

It is important to refer to the relevant checklist to analyze the answer made by TRIXELL to the various clauses

of the standards.

It is the responsibility to system integrator and/or hospital maintenance staff to properly configure the

embedded WiFi module with respect to the country where pixium EZ3 NDT detector is installed.

Note that the WiFi functionalities can only be used in the countries listed hereafter. For other countries, pixium

EZ3 NDT family detectors must be used in wired configuration and the WiFi modules switched off.

11.1. RED DIRECTIVE (EUROPE)

pixium EZ3 NDT is certified to be used in the following European countries:

Country (country code according to ISO 3166)

Andorra (AD)

Austria (AT)

Bosnia and

Herzegovina

(BA)

Belgium (BE)

Bulgaria (BG)

Croatia (HR)

Cyprus (CY)

Czech Republic

(CZ)

Denmark (DK)

Estonia (EE)

France (FR)

Finland (FI)

Germany (DE)

Greece (GR)

Hungary (HU)

Iceland (IS)

Ireland (IE)

Italy (IT)

Latvia (LV)

Liechtenstein

(LI)

Lithuania (LT)

Luxembourg

(LU)

Malta (MT)

Monaco (MC)

Montenegro

(ME)

Netherlands

(NL)

Norway (NO)

Poland (PL)

Portugal (PT)

Romania (RO)

San Marino

(SM)

Serbia (RS)

Slovakia (SK)

Slovenia (SI)

Spain (ES)

Sweden (SE)

Switzerland

(CH)

The former

Yugoslav

Republic of

Macedonia

(MK)

Vatican city

state (VA)

Table 9: European countries

For all of these countries, the 5.15-5.35 GHz band is restricted to indoor use.

Regulatory Statement:

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Operation of this device is subjected to the following National regulations and may be prohibited to use if

certain restriction should be applied.

English:

Hereby, TRIXELL, declares that the pixium EZ3 NDT is in compliance with the essential requirements and

other relevant provisions of Directive 2014/53/UE.

Finnish:

TRIXELL vakuuttaa täten että pixium EZ3 NDT tyyppinen laite on direktiivin 2014/53/UE oleellisten

vaatimusten ja sitä koskevien direktiivin muiden ehtojen mukainen.

Dutch:

Hierbij verklaart TRIXELL dat het toestel pixium EZ3 NDT in overeenstemming is met de essentiële eisen en

de andere relevante bepalingen van richtlijn 2014/53/UE.

Bij deze verklaart TRIXELL dat deze pixium EZ3 NDT voldoet aan de essentiële eisen en aan de overige

relevante bepalingen van Richtlijn 2014/53/UE.

French:

Par la présente, TRIXELL déclare que le pixium EZ3 NDT est conformes aux exigences essentielles et aux

autres dispositions de la directive 2014/53/UE qui lui sont applicables.

Swedish:

Härmed intygar TRIXELL att denna pixium EZ3 NDT står I överensstämmelse med de väsentliga

egenskapskrav och övriga relevanta bestämmelser som framgår av direktiv 2014/53/UE.

Danish:

Undertegnede TRIXELL erklærer herved, at følgende udstyr pixium EZ3 NDT overholder de væsentlige krav

og øvrige relevante krav i direktiv 2014/53/UE

German:

Hiermit erklärt TRIXELL, dass sich pixium EZ3 NDT in Übereinstimmung mit den grundlegenden

Anforderungen und den anderen relevanten Vorschriften der Richtlinie 2014/53/UE befindet". (BMWi).

Hiermit erklärt TRIXELL die Übereinstimmung des Gerätes pixium EZ3 NDT mit den grundlegenden

Anforderungen und den anderen relevanten Festlegungen der Richtlinie 2014/53/UE. (Wien).

Greek:

ΜΕ ΤΗΝ ΠΑΡΟΥΣΑ TRIXELL ΔΗΛΩΝΕΙ ΟΤΙ pixium EZ3 NDT ΣΥΜΜΟΡΦΩΝΕΤΑΙ ΠΡΟΣ ΤΙΣ ΟΥΣΙΩΔΕΙΣ

ΑΠΑΙΤΗΣΕΙΣ ΚΑΙ ΤΙΣ ΛΟΙΠΕΣ ΣΧΕΤΙΚΕΣ ΔΙΑΤΑΞΕΙΣ ΤΗΣ ΟΔΗΓΙΑΣ 2014/53/UE.

Italian:

Con la presente TRIXELL dichiara che questo pixium EZ3 NDT è conforme ai requisiti essenziali ed alle altre

disposizioni pertinenti stabilite dalla direttiva 2014/53/UE.

Spanish:

Por medio de la presente TRIXELL declara que los pixium EZ3 NDT cumple con los requisitos esenciales y

cualesquiera otras disposiciones aplicables o exigibles de la Directiva 2014/53/UE.

Portuguese:

Document Identification

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35 / 38

SIF-F-003

Document number

Code Type Document

Version

63150986

108

-d3

TRIXELL PROPRIETARY INFORMATION

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

TRIXELL declara que este pixium EZ3 NDT está conforme com os requisitos essenciais e outras disposições

da Directiva 2014/53/UE.

EU type examination certificate: RED_771

11.2. FCC RULES (U.S.A.)

This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant to

Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful

interference when the equipment is operated in a commercial environment. This equipment generates, uses,

and can radiate radio frequency energy and, if not installed and used in accordance with the instruction manual,

may cause harmful interference to radio communications. Operation of this equipment in a residential area is

likely to cause harmful interference in which case the user will be required to correct the interference at his

own expense

- FCC CAUTION -

Any changes or modifications not expressly approved by the party responsible for

compliance could void the user's authority to operate this equipment.

RF Exposure mobile Device:

This device complies with FCC and IC radiation exposure limits set forth for general population. This device

must be installed to provide a separation distance of at least 20cm from all persons and must not be co-located

or operating in conjunction with any other antenna or transmitter.

This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1)

this device may not cause harmful interference, and (2) this device must accept any interference received,

including interference that may cause undesired operation. received, including interference that may cause

undesired operation.

contains FCC ID : VPQ-WNFB265AXIBT

FCC ID: VPQ-EZ3NDTNFC

11.3. IC (CANADA)

This device contains licence-exempt transmitter(s)/receiver(s) that comply with Innovation, Science and

Economic Development Canada’s licence-exempt RSS(s). Operation is subject to the following two conditions:

(1) this device may not cause interference, and (2) This device must accept any interference, including

interference that may cause undesired operation of the device.

L’émetteur/récepteur exempt de licence contenu dans le présent appareil est conforme aux CNR d’Innovation,

Sciences et Développement économique Canada applicables aux appareils radio exempts de licence.

L'exploitation est autorisée aux deux conditions suivantes : (1) l'appareil ne doit pas produire de brouillage, et

(2) l’appareil doit accepter tout brouillage radioélectrique subi, même si le brouillage est susceptible d’en

compromettre le fonctionnement.

RF Exposure mobile Device:

This device complies with ISED radiation exposure limits set forth for general population. This device must be

installed to provide a separation distance of at least 20cm from all persons and must not be co-located or

operating in conjunction with any other antenna or transmitter..

Exposition aux radiations de l’appareil mobile:

Document Identification

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SIF-F-003

Document number

Code Type Document

Version

63150986

108

-d3

TRIXELL PROPRIETARY INFORMATION

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

Le présent appareil est conforme aux niveaux limites d’exigences d’exposition RF aux personnes définies par

ISDE. L’appareil ne doit pas être installé à proximité ou être utilisé en conjonction avec une autre antenne ou

un autre émetteur.

- CAUTION -

The device for operation in the band 5150–5250 MHz is only for indoor use to reduce the

potential for harmful interference to co-channel mobile satellite systems.

- AVERTISSEMENT -

Le dispositif fonctionnant dans la bande 5150-5250 MHz est réservé uniquement pour une

utilisation à l’intérieur afin de réduire les risques de brouillage préjudiciable aux systèmes

de satellites mobiles utilisant les mêmes canaux.

contains IC: 7392A-NFB265AXIBT

IC: 7392A-EZ3NDTNFC

11.4. MIC (JAPAN)

No mandatory text required for Japan. Only label apposed on devices containing ID are required. Note that 5

GHz band is not allowed to be used outdoor.

This equipment contains specified radio equipment that has been certified to the Technical Regulation

Conformity Certification under the Radio Law

11.5. OTHER COUNTRIES

For countries not listed here before, the system integrator must disable the RF functionalities (see appropriate

command in document [SIS]). In such configuration, pixium EZ3 NDT is compliant with CISPR 32 class A

limits and can be considered as non-radio product.

In such countries, the end-users must not be allowed to activate the RF functionalities by their own.

020-200125

5 GHz product for indoor use only.

Document Identification

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37 / 38

SIF-F-003

Document number

Code Type Document

Version

63150986

108

-d3

TRIXELL PROPRIETARY INFORMATION

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

12. APPENDIX E: RF COMMUNICATION

Since pixium EZ3 NDT can be used without any cable, it exchanges data (as commands, synchronization

images…) thanks to radio frequency modules which are able to operate in the ranges 2.412GHz…2.484GHz,

5.180GHz…5.320GHz, 5.500GHz…5.700GHz and 5.725GHz…5.825GHz.

The availability of some specific channels and/or operational frequency bands are country dependent and are

firmware programmed at the factory to match the intended destination. The firmware setting is not accessible

by the end-user.

pixium EZ3 NDT also contains a NFC module operating in 13.553 MHz ...13.657 MHz band.

12.1. RF FEATURES

 Operate at ISM frequency bands (2.4GHz and 5GHz)

 IEEE standards compatible: IEEE 802.11a, IEEE 802.11b, IEEE 802.11g, IEEE 802.11n; IEEE

802.11ac and IEEE 802.11ax

 WPA2-PSK/AES coding supported

12.2. RF SPECIFICATIONS

Functional specifications:

Standard

IEEE 802.11ax/ac/a/b/g/n (2T2R)

Operating frequency

2.400 GHz ~ 2.4835 GHz (2.4GHz ISM Band)

5.150 GHz ~5.850GHz (5GHz UNII Band)

Modulation techniques

802.11b: DSSS (DBPSK, DQPSK, CCK)

802.11g: OFDM (BPSK, QPSK, 16-QAM, 64-QAM)

802.11n: OFDM (BPSK, QPSK, 16-QAM, 64-QAM)

802.11a: OFDM (BPSK, QPSK, 16-QAM, 64-QAM)

802.11ac: OFDM (BPSK, QPSK, 16-QAM, 64-QAM, 256-QAM)

802.11ax: OFDMA (BPSK, QPSK, 16-QAM, 64-QAM, 256-QAM, 1024-

QAM)

Data Rate

802.11b: 11Mbps

802.11a/g: 54Mbps

802.11n: MCS0~15

802.11ac: MCS0~9

802.11ax: HE0~11

Network architecture

Infrastructure and Ad hoc modes

Transmission

MIMO 2x2

Table 10: RF specifications

Document Identification

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SIF-F-003

Document number

Code Type Document

Version

63150986

108

-d3

TRIXELL PROPRIETARY INFORMATION

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

12.3. EIRP

Measured EIRP (according to EN 300 328 v2.2.2 and EN 301 893 v2.1.1) are provided in [EUM].

END OF DOCUMENT

TRIXELL VPQ-EZ3NDTNFC pixium EZ3 NDT Portable X-Ray Detector

Product's Documents

User Manual

Specifications

TRIXELL VPQ-EZ3NDTNFC Questions and Answers

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