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CEFLA MyRay Hyperion X9 - User Manual

CEFLA MyRay Hyperion X9
75 pages
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97050543
Rev. 17
2018-12
hyperion X9
EN

Table of Contents

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Summary

Introduction and Indications for Use

Description of the Manual

Explains the manual's role as a guide for safe operation and maintenance of the X-ray system.

General Warnings

Covers general warnings related to the X-ray system, its software, and manufacturer policies.

Requirements (Not Provided with the Product)

Details system requirements not included with the device, focusing on PC compatibility.

Standards and Regulations

Lists the directives and technical standards the X-ray system complies with.

Classifications

Specifies the safety and medical device classifications of the X-ray system.

Stylistic Conventions

Explains the symbols used in the manual and on the X-ray device.

General Safety Warnings

Provides essential safety instructions and precautions for using the X-ray system.

Installation Conditions

Details the required environmental and technical conditions for system installation.

Conditions of Use

Outlines the proper conditions and staff qualifications for operating the equipment.

Warranty

Specifies the terms and conditions under which the device warranty is valid.

Maintenance and Disposal

Provides instructions for maintenance operations and proper disposal of the device.

Cleaning and Disinfection

Details the procedures for cleaning and disinfecting the X-ray device surfaces.

Hygiene Procedures for Patient Protection

Explains essential hygiene practices to prevent cross-infection between patients.

Safety Warnings

Covers critical safety warnings and precautions for device operation.

Conditions of Use (Safety)

Safety-related conditions for using the device.

General Safety

General safety guidelines to be followed during device operation.

Safety During X-ray Device Movements

Precautions to take when the X-ray device is in motion.

Emergency Button

Explains the function and use of the emergency stop button.

Condensate Formation

Information regarding condensate formation within the device.

Electrostatic Discharge

Details potential risks and precautions related to electrostatic discharge.

Exposure to Laser Radiation

Safety guidelines concerning laser radiation emitted by the device.

Electromagnetic Safety

Guidelines for safe operation in electromagnetic environments.

Protection Against Radiation

Procedures and measures for protecting patients and operators from radiation.

Applied Parts

Identifies parts of the device that necessarily contact the patient.

Stray Radiations

Provides data and context on leaked radiation measurements.

Description of Operation

Components

Lists and illustrates the various parts and accessories of the X-ray system.

Control Panel

Console Onboard the Machine

Details the functions and controls of the main console touchscreen and buttons.

Pushbutton Panel on Tele-X-ray Arm

Describes the pushbutton panel used for vertical movement and confirmation.

X-ray Emission Remote Control

Explains the operation and LEDs of the remote control for X-ray emission.

Perform a Simulation (Dummy Run)

Guides on how to perform a simulated X-ray cycle without radiation emission.

Performing a 2 D X-ray Examination

Starting the System

Instructions on how to turn on the X-ray device and wait for system readiness.

Selecting the Examination from the Control Console

Guides on selecting specific 2D X-ray examination types and categories.

Selecting an Examination

Details how to choose from available examinations on the HOME and EXAMINATION screens.

Setting an Examination for Children

Explains how to activate parameters adapted for pediatric examinations.

Setting a Current Examination as Favourite

Instructions on saving the current examination settings to the favourites list.

Setting the Projection Type

Describes how to switch between different projection types for various examinations.

Selecting a Reduced Anatomic Region

Guides on choosing specific anatomic regions for X-ray examinations.

Configuration of the X-ray Technique Factors

Details how to configure exposure parameters (kV, mA, seconds) based on patient build.

Preparation of the X-ray Examination

Covers the preparation steps before performing an X-ray examination.

Devices for Patient Positioning

Identifies and describes the devices used for positioning patients for X-rays.

Sensor Positioning

Explains how to correctly position and check the X-ray sensors.

Patient Access Status - Minimum Wait Status

Describes the system states for patient access and minimum wait time.

Examination Summary Page

Details the information displayed on the examination summary page.

Devices for Edentulous Patients (Optional)

Instructions for using soft inserts with bite blocks for edentulous patients.

Patient Positioning

General guidance on positioning the patient for X-ray examinations.

Laser Traces

Explains the function of laser traces in patient positioning.

Patient Positioning Description (Craniostat)

Detailed description and component breakdown of the craniostat for positioning.

Craniostat Motor-Driven Support

Instructions for adjusting the craniostat's motor-driven support.

PAN, DENT and SIN Examinations

Specific patient positioning steps for PAN, DENT, and SIN examinations.

TMJ Examination

Covers patient positioning for Temporomandibular Joint (TMJ) examinations.

Lateral TMJ

Step-by-step guide for positioning the patient for Lateral TMJ X-rays.

Frontal TMJ

Step-by-step guide for positioning the patient for Frontal TMJ X-rays.

Teleradiographic (CEPH) Examinations

Patient positioning instructions for Teleradiographic (CEPH) examinations.

Positioning for DTS Examination

Specific patient positioning guidance for DTS examinations.

Acquisition of the Exam

Final steps for acquiring the X-ray image after patient positioning.

3 D Tomographic Examination (CBCT)

Selecting the Examination from the Control Console

Guides on selecting CBCT examinations and preparing the system.

Positioning the Patient for 3 D Examinations

Details the procedure for positioning patients for 3D CBCT scans.

Performing the Examination

Instructions for completing the image acquisition for 3D CBCT exams.

Viewing and Saving

Viewing and Saving

Explains how to view acquired images and save them to a USB key.

Control Console

Language Selection

Guides on how to select the system language via the control console.

Touch Screen Display Icon

Explains the various icons and their functions on the touch screen interface.

Periodic Checks and Maintenance

Periodic Inspections to Check the Image

Details the procedures for periodic image quality control checks.

Technical Data

Electrical Characteristics

Provides specifications for the system's electrical power requirements.

Radiological Characteristics

Details the radiological specifications of the X-ray tube and system.

Radiological Features in CBCT Mode

Specific radiological parameters for CBCT mode operation.

Isodose Curves for CBCT Examinations

Presents isodose curves for CBCT examinations.

Isodose Curves for 2 D Examinations

Presents isodose curves for standard 2D examinations.

CTDI (Computed Tomography Dose Index) Measurements

Provides CTDI measurements for various scanning modes.

CBCT Detector Characteristics

Specifies the technical characteristics of the CBCT detector.

Panoramic Sensor Characteristics (PAN)

Details the technical specifications of the Panoramic (PAN) sensor.

Teleradiographic (CEPH) Sensor Characteristics (CEPH)

Specifies the technical characteristics of the Teleradiographic (CEPH) sensor.

Laser Characteristics

Provides specifications for the laser positioning system.

Dimensional Characteristics

Lists the physical dimensions and weight of the X-ray system.

Environment Characteristics

Details the operating and storage conditions for the device.

PC Requirements

Outlines the PC hardware and software requirements for CBCT acquisitions.

Identification Label Position

Illustrates the location of various identification and warning labels on the device.

Error Messages

User Communications

Lists user-communicated error codes, their messages, and suggested solutions.

Users Licence Contract

General Conditions of the Image Software Licence

Outlines the general terms governing the use of the image software.

Users Licence

Defines the non-exclusive, free-of-charge license granted for the software.

Copyright

Covers copyright laws, intellectual property rights, and software reproduction restrictions.

Use of the Software Product and Express Termination Clause

Specifies permitted software usage and conditions for license termination.

Guarantee and Exclusions from the Guarantee

Details the software warranty, its limitations, and exclusions.

Limits of Responsibility

States the author's and suppliers' responsibilities regarding software use and damages.

Applicable Laws, Jurisdiction and Court of Jurisdiction

Specifies the governing laws and jurisdiction for the license agreement.

Written Form

Stipulates that modifications to the agreement must be in written form.

Translation

Clarifies that the Italian version prevails in case of translation inconsistencies.

Software Compliance with the Regulations in Force

Addresses the user's responsibility to ensure software compliance with current regulations.

Inspection and Maintenance

User Inspection

Provides a checklist for users to perform regular equipment inspections.

Technical Maintenance

Outlines the maintenance procedures to be performed by authorized technicians annually.

CEFLA MyRay Hyperion X9 Specifications

General IconGeneral
BrandCEFLA
ModelMyRay Hyperion X9
CategoryMedical Equipment
LanguageEnglish

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