Spherical Phantom Application Research Kit Instructions For Use

Foreword

These instructions for use contain all the information necessary to operate the Spherical Phantom Application Research Kit (SPARK) in accordance with its specifications. This information includes explanations of the functions of the controls, displays and signals, the sequence of operation, and connection and disconnection of the parts and accessories you can remove.

You must regard these instructions as a part of the equipment. It is important that these instructions are read thoroughly.

Disclaimer

Gold Standard Phantoms considers itself responsible for the effects on safety, reliability, and performance of the equipment only if:

• Assembly operations, re-adjustments, modification or repairs are carried out by persons authorised by ourselves, and

• The electrical installation of the room where the device is used meets the requirements of the standards in force, and

• The device is used in accordance with this instruction manual.

Glossary and Abbreviations

Introduction

About this Instruction Manual

The purpose of this instruction manual is to promote the safe use of the Spherical Phantom Application Research Kit (SPARK) during its expected service life.
It describes the use of the device as intended by the manufacturer.

Identification

Product Name: Spherical Phantom Application Research Kit (SPARK)

Manufacturer and Contact Information

Intended Use

The Spherical Phantom Application Research Kit (SPARK) is designed to help user develop their own phantom for Quality Assurance measurements of Magnetic Resonance Imaging (MRI) or Magnetic Resonance Spectroscopy (MRS). Phantoms (also known as Quality Assurance Devices) are used in lieu of a human being inside an MRI scanner to assess its performance. The user should refer to the MRI device’s instructions for use to set up the correct pulse sequence for a given outcome. Equivalent acquisition techniques need to be used on the phantom as in the humans / patients.

Intended User

The SPARK is intended for use by qualified MRI system operating personnel. The device must be used by competent personnel who have the applicable education and experience. This includes but is not limited to:

• Radiographer/MRI Technologist

• Clinical Scientist/Hospital Physicists

• MRI Physicist

• Radiologist

• Students/Researcher

• Other trained Medical Professional.

The device must be used by a skilled person who has the applicable education and experience to enable them to perceive risks and to avoid hazards which operation or maintenance of the device can create

Warnings and Cautions Used

Essential safety descriptions are provided in the instruction manual in the form of either a Warning or a Caution, as described below:

A CAUTION is given when special instructions must be followed. Disregarding this advice can cause damage to the device or other equipment.

All users must familiarise themselves with all the warnings and cautions contained in the instructions before using this device.

Device Description

About the Spherical Phantom Application Research Kit (SPARK)

The Spherical Phantom Application Research Kit (SPARK) is designed to help user develop their own phantom for Quality Assurance measurements of Magnetic Resonance Imaging (MRI) or Magnetic Resonance Spectroscopy (MRS). It comes empty and enables the user to fill it up with their own fluid or gel to perform various tests on an MRI scanner.

Materials

Storage Instructions

Store

• In a dry and well-ventilated environment

• Between 15 °C and 30 °C

• Out of direct sunlight

If possible, store the phantom in the MRI magnet room. This will ensure that it is at thermal equilibrium with the room and provide the most reliable and reproducible results. Either store in the supplied box, or use the supplied stand to store on a flat surface such as a shelf.

Cleaning

If the Spherical Phantom Application Research Kit (SPARK) requires cleaning it can be cleaned with soap, water, and a soft cloth or sponge to remove dirt and debris. Organic solvents such as isopropanol may be used to remove sticky residue on the HDPE sphere, however these may cause the labels to stop adhering to the surface.

Operating Instructions

Unpacking

The Spherical Phantom Application Research Kit (SPARK) is supplied in a protective cardboard packaging box. To unpack:

1. Inspect the outer packaging. If any damage is present do not use the device. Please contact Gold Standard Phantoms.

2. Remove each component from the box.

3. Inspect each component for damage. If any damage is present do not use the device. Please contact Gold Standard Phantoms.

4. Carefully remove the outer packaging. Do not use a sharp knife in case this cuts or punctures the device.

Filling the Phantom

The SPARK is an HDPE sphere with threaded sealing cap, supplied empty for the user to fill with their own phantom material.

A funnel is supplied to aid filling the phantom.

Use

1. Place the on the MRI scanner couch in close proximity to the RF coil that is being used. It may help to use foam pads provided with the MRI scanner to aid positioning.

2. Align the MRI system’s laser with the middle of the phantom.

3. Move the phantom to magnet iso-centre.

4. Begin the MR examination.

5. When finished store the phantom.

Adverse Events

Any adverse events that occur during the use of this device should be reported both to Gold Standard Phantoms and the relevant Competent Authority of the member state.

Warranty

Standard Manufacturer’s Warranty (SMW)
The phantoms carry as 1 year manufacturer’s warranty. This covers assurance regarding quality / lifespan with a promise to repair or replace the Spherical Phantom Application Research Kit (SPARK) under a standard RMA (return merchandise authorisation). Shipping and Duty charges may apply.

Disposal

Disposal should be in accordance with local, state, or national legislation.