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Esaote O-scan Series - User Manual

Esaote O-scan Series
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Summary

Chapter 1 - Essential Prescribing Information

Description of the System

Describes the O-scan MR system, its main parts: patient seat, console, magnetic unit, and electronic box.

Intended Use

Details the O-scan system's purpose for imaging limbs and joints, specifying areas and technical parameters.

Contraindications

Lists conditions and patient types for which O-scan MR system use is contraindicated.

General Warning and Precautions

Outlines safety measures for controlled access areas and general precautions for system use.

MR Examinations of Infants and Pregnant Women

Highlights special precautions required for MR examinations involving newborns, infants, and pregnant women.

Maintaining Device Efficiency

Provides guidance on preserving O-scan system performance and image quality through proper maintenance.

Chapter 3 - Instructions for Safe Use

Operator Profile

Defines the operator's qualifications, training, and physical requirements for safe system use.

Use Environment

Specifies the intended actual conditions and settings for users interacting with the O-scan medical device.

Controlled Access Area

Details the definition and importance of a controlled access area around the O-scan system for safety.

Peripheral Equipment

Outlines requirements for peripheral equipment used within the controlled access area, emphasizing MR safety.

Projectiles

Warns about ferromagnetic objects being attracted by the magnetic field, posing a projectile risk.

Artifacts

Explains causes of image artifacts, including magnetic field disturbances and shielding element efficiency.

Peripheral Equipment Compatibility Test

Describes the susceptibility test protocol to assess O-scan system compatibility with peripheral equipment.

Patient Area

Defines the patient area where intentional/unintentional contact can occur, ensuring safety levels.

Pre-screening of Patients

Emphasizes careful evaluation of patient risks, history, and contraindications before examinations.

Special Precautions: Patients with Metal Objects in the Body

Details precautions for patients with metal implants, emphasizing MR Conditional assessment.

Special Precautions: Pregnant or Infant Patients

Highlights special precautions for MR examinations involving pregnant women and newborn babies.

Special Precautions: High Risk Patients

Outlines special precautions for patients with high risks like cardiac arrest, seizures, or claustrophobia.

Monitoring the Patient during MR Examinations

Stresses the importance of maintaining patient communication and monitoring well-being during examinations.

Pre-screening of MR Personnel

Requires evaluation of risks associated with MR personnel's history and tasks before entering the controlled access area.

Emergency Medical Procedure

Defines emergency procedures to assist patients during MR examinations, including patient removal from fields.

Operating Mode

Specifies the O-scan system's operating mode as Normal Operating Mode according to EN 60601-2-33 standards.

Personnel and Patient Exposure to the Acoustic Noise

Addresses acoustic noise levels generated by the O-scan system and necessary precautions.

Special Precautions Against Acoustic Noise

Recommends ear protection for sedated patients or in high noise environments to prevent hearing impairment.

Personnel and Patient Exposure to the Static Magnetic Field

Discusses safety issues related to static magnetic fields, biological effects, projectile effects, and implanted devices.

Fringe Magnetic Field

Illustrates magnetic fringe field maps on different planes and describes field isolines.

Main Magnetic Field and Main Magnetic Field Gradient

Details positions of maximum magnetic field and gradient, and their spatial coordinates relative to the magnet isocenter.

Personnel and Patient Exposure to the Time-Varying Magnetic Field

Explains induced electric fields from time-varying magnetic fields and potential stimulation of body systems.

Patient

Addresses field intensity increase towards gantry side walls and precautions for knee examinations.

MR Personnel

Discusses exposure levels for MR workers to electric fields and relevant regulations.

MR Personnel and Patient Exposure to the RF Magnetic Field

Covers heating as a consequence of RF exposure and SAR comparison with induced heat.

MR Personnel and Patient Exposure to Contact Currents

Explains contact current generation and O-scan system conformance to directives and standards.

Precautions Against Localized Cutaneous Heating

Details risks of localized heating due to closed conductive loops formed by patient contact with coils or cables.

Special Precautions for Patient Positioning

Highlights dimensional restrictions and patient comfort considerations for safe and effective positioning.

Precautions Against Mechanical Hazards

Addresses mechanical stability and precautions for patient seat, leg rest, and padded lateral supports.

Precautions Against Electric Shock

Stresses that installation, maintenance, and repair must be done by authorized personnel.

Fire and Explosion Precautions

Provides precautions regarding cleaning agents, flammable substances, and appropriate fire extinguishers.

Precautions When Using the Contrast Agent in MR Examinations

Details precautions for using paramagnetic contrast agents, including manufacturer labeling and potential adverse effects.

Disinfecting and Cleaning the System

Outlines procedures for disinfecting and cleaning the O-scan system after contact with infected materials.

Periodic Maintenance

Lists periodic maintenance procedures to be performed by authorized service personnel and their frequency.

Quality Assurance

Describes the image quality test implemented to measure Signal-to-Noise ratio and verify image quality stability.

Automatic Shimming

Explains the automatic shimming test for evaluating and correcting magnet homogeneity.

System Life Cycle

Specifies the system's lifetime guarantee and maintainability period from the date of purchase.

Correct Management and Privacy of Patient Data

Emphasizes the critical nature of patient data modifications and the responsibility for conserving CSV files.

Conformance to Standards

Confirms O-scan compliance with Medical Equipment Directive 93/42/EEC and various EN standards.

CHAPTER 4 Installation

Structural Requirements of the Installation Area

Specifies minimum clearances and floor load capacity requirements for O-scan system installation.

Electromagnetic Requirements in the Installation Environment

Details EMC requirements, including LAN connection specifications and warnings about incompatible cables.

Guidance and Manufacturers Declaration - Electromagnetic Emissions

Provides declarations on RF and harmonic emissions compliance and guidance for electromagnetic environments.

Guidance and Manufacturers Declaration - Electromagnetic Immunity

Details immunity test levels and compliance for ESD, electrical fast transients, surge, voltage dips, and power frequency fields.

Recommended Distances between Radiofrequency (RF) Communication Systems and O-scan

Recommends maintaining minimum distances from RF systems to prevent interference with the MRI system.

Magnetic Disturbance

Advises against installing the system near large ferrous masses or equipment causing magnetic field fluctuations.

RF Disturbances

Warns against installing near devices with frequent activation/shutdown or in areas with voltage fluctuations.

Power Requirements

Outlines system power supply, consumption, grounding, and connection specifications for electrical mains.

Light Indicators

Describes the function of green and blue indicator lights on the electronic cabinet and PC.

Safety Symbols

Illustrates and defines common safety symbols used on the O-scan system equipment.

Thermal Stability

Explains the need for constant magnet temperature and the function of the thermostat control circuit.

Environmental Requirements

Specifies ambient temperature, humidity, and other environmental conditions for optimal system operation.

Site Preparation

Details system modularity, positioning flexibility, and cable routing requirements for installation.

Patient Routine Monitoring Requirements

Recommends audio and visual contact between physician and patient during examinations.

Installation Procedure

States that installation must be carried out by authorized technical assistance personnel.

Controlled Access Area

Details the definition and importance of a controlled access area around the O-scan system for safety.

Warning Labels

Instructs on affixing warning and prohibition labels and marking the 0.5 mT line on the floor.

Environmental Conditions for Transport and Storage

Specifies temperature, pressure, humidity, and exposure time limits for O-scan system transport and storage.

Special Storage and Transport Conditions

Outlines measures for handling the magnetic unit during transport due to fringe field presence.

Packaging Symbols

Describes symbols found on shipping crates warning of magnetic fields and handling precautions.

CHAPTER 5 Technical Description

O-scan Features

Highlights key features: ultra-compact magnet, integrated Faraday cage, self-centering mechanism, and specialized devices.

System Architecture

Describes the O-scan system's electrical medical device components and accessories.

Accessories

Lists additional items such as operator table, magnetic compensation kit, and E-MRI viewer.

Information Technology Equipment

Details the PC, including keyboard, mouse, and SDSP card, and monitor specifications.

Operating Console

Explains the console as the instrument for operator interaction, covering PC, monitor, keyboard, and mouse.

Monitor Specifications

Provides detailed specifications for the system's LCD/TFT/LED monitor, including resolution and connectors.

System Electronics

Describes the electronic components housed in the electronic box, including power supply and PC details.

Power Supply

Details the components of the power supply system: TRI transformer and DISTR unit.

PC

Describes the PC and SDSP card, outlining their functions for signal acquisition and monitoring.

Electronic Box

Details the functions of the ACM, TCM, SRN, and RISC cards within the electronic box.

GRA Gradient Amplifier

Explains the GRA's role in supplying voltage/current to gradient coils and its CGM card functions.

RF Amplifier

Describes the RF amplifier's capability to supply transmission coils with power for faster pulse sequences.

Cards on Magnetic Unit

Lists the HEATER card and DIM card used for connecting the electronic cabinet and displaying real-time images.

Computer Functions

Summarizes the processes controlled by the computer, including user dialogue, malfunction control, and data management.

Magnetic Unit

Details the components of the magnetic unit: magnet, gradient coils, RF transmission coil, RF screen, receiving coils, and thermal control.

Technical Specifications

Lists technical specifications for the imaging system, acquisition methods, slice thickness, and spatial resolution.

CHAPTER 6 Patient Seat and Cinematic Devices

Description of Patient Seat

Details the patient seat's design for comfort, including its padded bed, castor wheels, track, and handle.

Patient Seat in the eXP and Premium Configurations

Describes the patient seat's features in eXP and Premium configurations, including adjustable armrests for patient positioning.

Other Supports

Introduces two padded supports applied to the magnetic unit for examining knees, calves, ankles, or feet.

Device for Cinematic Examinations of the Knee

Explains the device for knee cinematic studies, its ability to maintain position, and generate stress conditions.

Procedure for Standard Use

Provides step-by-step instructions for using the cinematic knee device, including knob operations and adjustments.

Procedure to be Followed Before Knee Examinations

Outlines steps to prepare the cinematic knee device before inserting the patient's limb into the gantry.

Procedure to be Followed After Knee Examinations

Details the steps required to remove the patient's limb and return the cinematic knee device to its original state.

Procedure for Using the Device for Cinematic Studies

Explains how to perform cinematic studies of the knee by acquiring consecutive images at different bending angles.

Procedure for Using the Patient Seat and Devices for Cinematic Studies

Guides the user through using the patient seat and devices for cinematic studies, referencing relevant chapters.

Hand;Wrist Positioner

Introduces the hand/wrist positioner, its components, and its purpose in stabilizing limbs for examinations.

Positioner Description

Details the components of the hand/wrist positioner: support, positioning plate, cushions, and straps.

Support

Explains the two types of supports used with the hand/wrist positioner, depending on the coil.

Positioning Plate

Describes how to fix the positioning plate guide to the base and adjust the plate using a knob and graduated scale.

Dedicated Cushions and Pins

Explains the placement of cushions and pins on the positioning plate to ensure patient comfort and limb stability.

CHAPTER 7 Shielding and Insulating Parts

Description and Use of Shielding Collars

Describes shielding collars as conductive fabric cylinders for limb shielding and their connection to the gantry.

Integrity Check of Shielding Collars

Provides steps for performing a periodic inspection of shielding collar integrity using a phantom and specific commands.

Description of the Shielding Straps

Explains the use of aluminum straps to improve electrical contact between the patient's skin and shielding straps.

Insulating Strap

Details the fabric insulating strap used to prevent thigh contact with the gantry, essential for O-scan operation.

Cleaning, Replacement and Disposal

Provides instructions for cleaning, replacing, and disposing of shielding covers and straps according to regulations.

CHAPTER 8 Coils

Dual Phased Array Coils

Introduces Dual Phased Array coils, their structure, and benefits over solenoidal coils for signal-to-noise ratio.

Description of DPA Knee Coil 1

Details the DPA Knee Coil 1, its dimensions, base engagement, quick connector, and use with rectangular cushions.

Description of Hand;Wrist DPA Coil 2

Describes the Hand/Wrist DPA Coil 2, its dimensions, gantry engagement, connector, and use with rectangular cushions.

Description of Foot;Ankle DPA Coil 3

Details the Foot/Ankle DPA Coil 3, its shoe-like shape, dimensions, gantry engagement, connector, and use with special cushions.

Precautions When Using Coils

Highlights precautions for handling receiving coils, including avoiding shocks, careful insertion, and cleaning procedures.

Phantoms

Describes various phantoms used for system tuning, quality tests, and magnetic compensation analysis.

CHAPTER 9 Soft Cushion Set

Cushion List

Lists all items in the Soft Cushion Set and their corresponding O-scan system parts.

Patient Seat

Identifies the cushions for the patient seat: backrest cushion and headrest.

Cushions Holder for Knee Coil 1

Explains the function of the cushions holder for Knee Coil 1 in correctly positioning the knee.

Lumbar Support Cushion

Describes the lumbar support cushion placed between the seat and patient's back to improve comfort, especially for hand/wrist/elbow exams.

General Use

Provides general notes on cushion compressibility, selection, placement, and stacking for optimal patient positioning and image quality.

CHAPTER 10 Positioning Protocols

Size Constraints of the O-scan System

Details gantry opening dimensions and distance from entrance point to magnet center affecting examination possibilities.

Centering the Coil and the Anatomy to be Examined

Emphasizes positioning the coil and anatomical region in the center for optimal image quality and Scout sequence verification.

Image Quality

Provides recommendations for optimal image quality, including coil selection, limb immobilization, and use of shielding.

Removing the Patient in an Emergency

Outlines the step-by-step procedure for quickly removing a patient from the unit in an emergency situation.

CHAPTER 11 Knee Examinations

Usable Coils

Identifies Knee coil 1 (DPA) as the usable coil for knee examinations.

Cushions and Insulating Straps

Specifies the use of rectangular cushion types P and insulating straps for correct knee examination positioning.

Patient Positioning Procedure

Provides detailed steps for positioning the patient for knee examinations, including seat adjustment, shielding collars, and coil insertion.

Cinematic Knee Examinations

Explains how to perform cinematic studies of the knee by acquiring consecutive images at different bending angles.

Examination of Cruciate Ligaments and the Femor-Rotula Joint

Details the procedure for examining cruciate ligaments and the femor-rotula joint using the knee examination protocol.

CHAPTER 12 Calf Examinations

Usable Coils

Identifies DPA Knee coil 1 as the usable coil for calf examinations.

Cushions and Insulating Straps

Specifies the use of rectangular cushion types P and insulating straps for correct calf examination positioning.

Patient Positioning Procedure

Provides steps for positioning the patient for calf examinations, including seat adjustment, shielding collars, and coil insertion.

CHAPTER 13 Foot - Ankle Region Examinations

Usable Coils

Identifies DPA Knee Coil 3 and DPA Knee coil 1 for foot-ankle examinations based on patient size.

Cushions

Lists required cushions (SC1, SC1+SC2, P, C) for correct patient positioning in foot-ankle examinations.

Ankle Examinations: Patient Positioning Procedure

Details the patient positioning procedure for ankle examinations using DPA Foot/Ankle Coil 3 or DPA Knee Coil 1.

Forefoot Examinations: Patient Positioning Procedure

Provides steps for positioning the patient for forefoot examinations, including seat and cushion placement.

Achilles Tendon Examinations: Patient Positioning Procedure

Outlines the patient positioning procedure for Achilles' tendon examinations, considering large feet and seat adjustments.

CHAPTER 14 Hand-Wrist Examinations

Usable Coils

Identifies DPA Hand/Wrist Coil 2 and DPA Foot/Ankle Coil 3 as usable coils for hand-wrist examinations.

Cushions

Lists required cushions (rectangular types P, RB Cushion, Lumbar support cushion) for hand-wrist examinations.

Hand Examinations: Patient Positioning Procedure

Details the procedure for positioning the patient's hand for examinations using DPA Hand/Wrist Coil 2 or DPA Foot/Ankle Coil 3.

Wrist Examinations: Patient Positioning Procedure

Provides steps for positioning the patient's wrist for examinations, including coil insertion and cushion placement.

CHAPTER 15 Elbow Examinations

Usable Coils

Identifies DPA Hand/Wrist Coil 2 and Foot/Ankle Coil 3 for elbow examinations based on patient size.

Cushions

Lists required cushions (rectangular types P, Lumbar support cushion) for elbow examination positioning.

Patient Positioning Procedure

Details the procedure for elbow examinations, including coil insertion, cushion placement, and shielding collar use.

CHAPTER 16 Forearm Examinations

Usable Coils

Identifies DPA Hand/Wrist coil 2 and Foot/Ankle Coil 3 for forearm examinations based on patient size.

Cushions

Lists required cushions (rectangular types P, Lumbar support cushion) for forearm examination positioning.

Patient Positioning Procedure

Provides steps for forearm examinations, including coil insertion, cushion placement, and shielding collar use.

CHAPTER 17 Turning the System On and Off

Turning on the System

Describes the procedure to start up the O-scan system, including PC and system electronics power-on.

Turning off the PC or User Logoff

Details steps for closing the user interface, disconnecting the user, and shutting down the system completely.

Emergency Stop

Explains how to block RF impulses and magnetic field generation in emergency situations via software or main switch.

CHAPTER 18 Control Panel

Control Panel

Describes the control panel's location and function for real-time acquisition management on the O-scan system.

Real Time Positioning

Enables image acquisition every 2 seconds for facilitating anatomical region positioning via the control panel.

Control Panel Orientation

Explains setting the control panel in standard or inclined positions to aid patient positioning and supervision.

Turning the Control Panel On and Off

Details how to enable the control panel via the user interface and its power management during scans.

APPENDIX A General Principles of Magnetic Resonance Imaging

The Nuclear Spin System

Explains the quantum mechanical property of spin in atomic nuclei and its relation to magnetic moment.

The Role of RF Pulse

Describes how RF pulses disturb proton alignment, causing resonance and transverse magnetization, generating the MR signal.

Relaxation Times

Explains T1 and T2 relaxation times and their importance in identifying tissue characteristics and signal source.

From Signal to Image

Details how RF pulses create transverse magnetization and FID signals, and how relaxation times are measured to form images.

Esaote O-scan Series Specifications

General IconGeneral
Gantry DesignOpen
Magnetic Field Strength0.25 T
Magnet TypePermanent
Scan RegionExtremities
Field Strength0.25 T

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