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Thales Pixium - User Manual

Thales Pixium
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Microwave & Imaging Sub-Systems
460 rue du Pommarin
38430 Moirans - France
Tel: +33 4 76 57 52 80
Document Reference : 63137046 -
January 2024
Page 1
OPEN
This document may not be reproduced, modified, adapted, published, translated, in any way, in whole or in part, or disclosed to a third party without the prior written consent of THALES.
© 2017-2023 THALES All rights reserved
83270259-SER-MIS-EN-002
0123
PIXIUM STATIC X-RAY FLAT PANEL DETEC-
TORS
END USER MANUAL

Table of Contents

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Summary

Document History

Disclaimer

Symbols

End User Symbols Definition

Defines symbols used by end-users for safety and operational guidance.

Products Symbols Definition

Explains symbols related to product identification and features.

Labels And Packaging Symbols Definition

Details symbols found on product labels and packaging for compliance and information.

Glossary

Device Information

Product Scope

Outlines the specific medical devices and accessories covered by the manual.

Medical Devices Applications

Describes the intended use and functionality of the Pixium Static Detectors in medical imaging.

IT Networks Characteristics

Details IT network requirements, including PC host characteristics for software compatibility.

IT Security

Provides guidance on IT security measures for running the associated software.

Product Legal Manufacturer and Manufacturing Site

Identifies the legal manufacturer and manufacturing location of the device.

Intended User

Specifies the target audience for integration and use of the Pixium detectors.

Intended Purpose (For EU Countries Only); Indication For Use (USA only)

Defines the specific medical applications and purpose of the detectors in different regions.

Indications

Lists the anatomical regions and patient positions suitable for imaging with the detectors.

Intended Patient Population

Specifies if there are any limitations on the patient target group or selection criteria.

Contraindications

Highlights medical procedures or conditions for which the detectors are not intended.

Limitations

Details any known limitations in the functionality or performance of the detectors.

Adverse Effects; Undesirable Side-effects

Describes potential negative outcomes or side effects associated with detector use.

Acclimatization Time

Provides information on the time needed for the detector to acclimatize after unpacking.

Main Physical Characteristics

Details the key physical specifications and features of the detector models.

Safety And Precautions

General Precautions

Lists essential safety measures and general precautions for using the detector.

Shocks

Explains the detector's shock sensor feature and its implications for warranty.

Radio Frequency Protection

Advises on precautions to avoid interference with radio frequency devices.

Electro Magnetic Compatibility (EMC) Compliance

Details EMC compliance information and precautions for system integration.

Applied Parts

Identifies parts of the detector that may come into direct contact with the patient.

Biocompatibility

Provides information on the biocompatibility of the detector for patient contact.

Sterile

States whether the detector is delivered sterile.

Pacemaker

Offers warnings and precautions for users with pacemakers.

Degree Of Safety (Flammable Anesthetic Mixture)

Specifies conditions related to flammable anesthetic mixtures where the equipment is not suitable.

Disposal

Provides instructions and warnings regarding the proper disposal of the detector.

X-Ray Management

Guides on managing X-ray exposure and detector interaction during operation.

Performance

Presents technical performance data and specifications for the detector.

Accessories Important Safety Instructions

Outlines critical safety instructions for the detector's accessories.

Cables

Provides specific safety warnings related to the detector's cables, especially concerning pacemakers.

FCC Rules (U.S.A.) Pixium EZ HD

Details FCC compliance statements and regulations for the device in the USA.

RED Directive (Europe)

Explains RED directive compliance and country-specific usage restrictions for Europe.

Wi-Fi Interface

PIXIUM 3543 EZ-C HD

Describes the Wi-Fi interface for the Pixium 3543 EZ-C HD detector.

PIXIUM 4343 EZ-C HD

Describes the Wi-Fi interface for the Pixium 4343 EZ-C HD detector.

LED Indicators

LED Location

Shows the physical location of the LEDs on the Pixium EZ-C HD series.

LED Indicator PIXIUNM EZ-C HD Series

Explains the meaning and behavior of the LED indicators on the detector.

Battery

PIXIUM EZ HD Series

Details the battery specifications and handling for the Pixium EZ HD series.

Turn ON, Turn OFF

PIXIUM EZ-C HD Series

Provides instructions on how to power the detector on and off.

Maintenance And Cleaning

Daily Inspection

Lists the daily checks to be performed before using the product.

Monthly and Yearly Inspection

Outlines inspection tasks to be performed monthly and yearly.

PIXIUM PORTABLE EZ-C HD Cleaning

Provides specific cleaning instructions for the Pixium EZ HD detector.

PIXIUM All SERIES Cleaning

Details general cleaning procedures applicable to all Pixium series detectors.

Cleaning Agent

Lists approved cleaning agents and their active substances for detector maintenance.

Dark Calibration

Explains the process and importance of dark calibration for image quality.

X-RAY Calibration

Describes the procedure and requirements for X-ray calibration of the detector.

Regular Maintenance

Details regular maintenance activities and safety checks according to IEC 62353.

Operating Conditions

PIXIUM PORTABLE EZ-C HD Series Operating Conditions

Specifies the environmental and operational conditions for the PIXIUM PORTABLE EZ-C HD series.

Storage And Handling

PIXIUM PORTABLE EZ-C HD Series Environmental Storage and Transport

Details environmental requirements for storage and transport of the detector.

End-User Technical Support

Thales Pixium Specifications

General IconGeneral
ScintillatorCesium iodide (CsI)
Field of ViewVaries depending on model and configuration
Detection CapabilityX-ray imaging
Operating TemperatureTypically 10°C to 35°C
WeightVaries depending on model and size
DimensionsVaries depending on model and size

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