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NewTom VG Series - User Manual

NewTom VG Series
72 pages
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0051
97050869
Rev. 3
28.04.2017
NewTom VGi evo
User Manual
EN

Table of Contents

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Summary

INTRODUCTION TO THE MANUAL

CONTENTS

Overview of manual's sections and their content.

STRUCTURE

Explains the manual's organization and chapter breakdown.

STYLISTIC CONVENTIONS

Details formatting, symbols, and notes used in the document.

SAFETY-RELATED INFORMATION

APPLICABLE LAWS, JURISDICTION AND COURT OF JURISDICTION

Outlines legal compliance requirements for device installation, maintenance, and use.

SYMBOLS ON THE DEVICE

Explains the meaning of various device labels and icons.

DEVICE SWITCHING ON AND OFF

Procedures for powering the device on and off.

EMERGENCY SWITCHING OFF

How to perform an emergency shutdown of the device.

SAFETY OF PATIENT AND OPERATOR

General safety measures for users and patients during operation.

PATIENT POSITIONING

Correct placement of patient for scans to ensure safety.

DURING THE SCANNING

Safety protocols and supervision requirements during the scanning process.

PATIENT GOING OUT OF THE SCANNING AREA

Procedure for patient exit after examination or emergency stop.

ARTEFACTS AND SCANNING REPETITION

Reasons for re-scanning images due to artefacts or positioning issues.

PROTECTION AGAINST IONIZING RADIATIONS

Safety guidelines and precautions for radiation exposure.

PROTECTION AGAINST LASER RADIATIONS

Safety precautions for using the laser positioning aids.

DEVICES CONNECTED TO THE CONTROL CONSOLE

Compliance requirements for connected peripheral devices.

MAINTENANCE INTERVAL

Schedule for device upkeep and servicing.

APPLIED PARTS

Components that come into contact with the patient.

DEVICE SAFETY AND MAINTENANCE

INSTALLATION REQUIREMENTS

Conditions and requirements for setting up the device.

SAFETY GUIDELINES

General safety rules and precautions for device operation.

CHANGES TO THE DEVICE

Procedures and restrictions for device modifications.

LIMITS OF RESPONSIBILITY

Manufacturer's liability regarding unauthorized changes or improper use.

DEVICE MAINTENANCE

General maintenance procedures and safety warnings.

DEVICE MAINTENANCE

Details on specific maintenance types and procedures.

DEVICE MAINTENANCE

Maintenance schedule and required checks for the system.

CLEANING AND DISINFECTION

Procedures for cleaning and disinfecting the device.

HYGIENE PROCEDURES FOR PATIENT PROTECTION

Hygiene measures for patient safety and cross-contamination prevention.

STERILISATION

Sterilization requirements for device components.

TRANSPORT AND STORAGE

Guidelines for moving and storing the device.

DEVICE DISPOSAL

Procedures for disposing of the equipment at end-of-life.

INFORMATION FOR DEVICE OWNER

Responsibilities of the device owner regarding disposal.

INFORMATION FOR COLLECTION; DISPOSAL; RECOVERY FACILITIES

Procedures for disposal facilities handling the equipment.

STARTING PROCEDURES

INTRODUCTION TO THE SYSTEM

Overview of the NewTom VGi evo system.

INTENDED USE

Defines the device's primary purpose and application.

INDICATIONS FOR USE

Specifies clinical applications and scenarios for the device.

IMPROPER USE

Lists prohibited or incorrect uses of the device.

FUNCTIONING

Describes how the system operates.

OPERATION PRINCIPLE

Explains the underlying technology of the scanning system.

OVERVIEW

Lists the main system components.

SCANNER

Details about the scanner unit.

OPERATOR CONSOLE AND CONTROLS

Describes the user interface and control buttons.

SCANNER MOVEMENT

Controls for scanner positioning and arm movement.

CHINREST SYSTEM MOVEMENT

Controls for chinrest adjustments.

INFORMATION MENU

Accessing system information.

SERVICE MENU

Accessing service functions.

OTHER FUNCTIONS

Icons and indicators on the console screen.

X-RAY EMISSION

Status indication for X-ray emission.

CONTROL BOX

Description of the control unit.

MAIN SWITCH

Location and function of the main power switch.

INPUT PANEL

Details of the control box input connectors.

STANDARD ACCESSORIES

List of included equipment and accessories.

X-RAY EMISSION REMOTE CONTROL

Operation of the remote control for X-ray emission.

CABLES

Information on connection cables for system components.

STARTING THE SYSTEM

Step-by-step power-on procedure for the system.

SYSTEM SWITCHING OFF

Step-by-step power-off procedure for the system.

PRELIMINARY OPERATIONS

DAILY CHECK

Procedure for daily system verification.

BLANK ACQUISITION

Procedure for acquiring a background image.

BLANK ACQUISITION INVALIDATION

How to invalidate a blank acquisition.

BEAM LIMITER TEST

Testing the X-ray beam collimation.

LOWERING THE ROTATING ARM COMPLETELY

Procedure for arm retraction, useful for transport.

SCANNING

SCANNING A PATIENT

Procedures for patient scanning.

PREPARING THE PATIENT

Steps for patient preparation before scanning.

CRANIOSTAT USE

How to use and adjust the craniostat.

CRANIOSTAT USE

Continued adjustment details for craniostat.

POSITIONING THE PATIENT AND STARTING THE SCANNING

Placing and starting the scan for patients.

POSITIONING THE PATIENT AND STARTING THE SCANNING

Detailed patient positioning steps.

SPECIAL CONSIDERATIONS FOR CHILDREN AND SMALL PATIENTS

Specific guidance for pediatric scans.

SCANNING A PROSTHESIS

Procedure for scanning prosthetic objects.

PRELIMINARY OPERATIONS

Data entry for prosthesis scans.

POSITIONING THE PROSTHESIS

Placing the prosthesis for scanning.

QUALITY CONTROL

PHANTOM POSITIONING

Steps to position the QA phantom for quality control.

IMAGE EXAMPLES

Sample images from phantom analysis.

SAVING THE PHANTOM ANALYSES

How to save phantom analysis reports.

TROUBLESHOOTING

APPENDIX A: TECHNICAL SPECIFICATIONS

Scanning parameters

Details on scanning modes, field of views, and exposure.

Scanner dimensions and weight

Physical specifications of the scanner unit.

X-ray image scout view specifications

Pixel data for scout images across different FOVs.

Reconstructed volume specifications

Details on reconstructed image sizes and voxel dimensions.

Reconstructed volume specifications

Further details on reconstructed volume dimensions.

Reconstructed volume specifications

Additional reconstructed volume dimensions.

X-ray Parameters

Technical data for the X-ray tube.

Anode heating and cooling curves

Thermal performance curves for the anode.

Single Load Rating Curves

Tube current limits vs. exposure time for various kV.

Single Load Rating Curves

Tube current limits vs. exposure time for various kV.

Single Load Rating Curves

Tube current limits vs. exposure time for various kV.

Single Load Rating Curves

Tube current limits vs. exposure time for various kV.

Cathode emission characteristics

Relationship between filament current and tube current.

Mono-block and Inverter specifications

Details on system sub-assemblies like mono-block and inverter.

X-ray generator-tube-sheath assembly and Inverter

Further technical specifications for generator components.

Stray Radiation Map and Laser specifications

Radiation patterns and laser system data.

Other information and Electromagnetic compatibility (EMC)

Environmental conditions and EMC guidance.

EMC Immunity Test Levels

Electrical immunity standards and test levels.

EMC Immunity Test Levels

RF immunity standards and test levels.

EMC Recommendations for RF devices

Guidelines for safe proximity to RF devices.

APPENDIX B: COMPATIBILITY

Standards and Classifications

Lists relevant IEC standards and device classifications.

APPENDIX C: DEVICE LABELS

Scanner Unit Labels

Labels found on the scanner unit.

Control Box Labels

Labels found on the control box.

Component Labels

Labels for specific system components.

Commercial Name and Certification Labels

Device branding and certification labels.

Beam Limiter and Filter Labels

Labels for beam limiter and filters.

Connector, Laser, and Hazard Labels

Labels for connectors, lasers, and hazards.

Stop and Chinrest Labels

Labels on emergency buttons and chinrest covers.

Device Commercial Name and Contact Information

Manufacturer and distributor contact details.

NewTom VG Series Specifications

General IconGeneral
BrandNewTom
ModelVG Series
CategoryMedical Equipment
LanguageEnglish

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