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FUNSTAR Instructions For Use
|
Gold Standard Phantoms |
Document ID: PD-3001-0032 |
| Revision | Summary | Date |
|---|---|---|
| 1.0 | 1st version of IFU | 6 Mar 2025 |
Foreword
These instructions for use contain all the information necessary to operate the FUNSTAR/Veriflux and FUNSTAR Jr phantoms 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
Term | Description |
|---|---|
MRI | Magnetic Resonance Imaging |
MRS | Magnetic Resonance Spectroscopy |
fMRI | functional Magnetic Resonance Imaging |
FUNSTAR | Functional Stability Reference |
Introduction
About this Instruction Manual
The purpose of this instruction manual is to promote the safe use of the FUNSTAR (Functional Stability Reference), FUNSTAR Jr and VERIFLUX during its expected service life.
It describes the use of the device as intended by the manufacturer.
Identification
Product Name: FUNSTAR/Veriflux
Manufacturer and Contact Information
Company Identification | Gold Standard Phantoms Limited |
Telephone | +44 (0)114 3271540 |
Email (competent person) | |
Languages spoken | English |
EU Authorised Representative | AR Experts B.V. |
EU Authorised Representative Address | AR Experts B.V. Amerlandseweg 7 3621 ZC Breukelen The Netherlands |
EU Authorised Representative Email Address |
Intended Use
The FUNSTAR/Veriflux and FUNSTAR Jr are spherical gel stability phantoms designed to assess and monitor the accuracy, reproducibility, and stability of Magnetic Resonance Imaging (MRI) systems. These phantoms are specifically intended for evaluating the performance of functional Magnetic Resonance Imaging (fMRI) techniques and applications.
The FUNSTAR/Veriflux and FUNSTAR Jr phantoms provide standardised and reproducible imaging conditions within MRI systems to ensure reliable system stability assessments, detect variations in MRI performance over time, and evaluate the performance limits of fMRI techniques. By establishing a uniform quality assurance protocol, they facilitate consistent data acquisition across different sites, scanners, and configurations. These phantoms are intended for use in routine quality assurance, system calibration, and performance benchmarking in both research and clinical MRI environments.
The FUNSTAR and Veriflux products are identical in their construction and contents. FUNSTAR is targeted towards scientific and research customers, whereas the Veriflux phantom is a clinical product that accompanies the Veriflux Software as a Service fMRI Quality Assurance Platform (https://goldstandardphantoms.com/veriflux/ ). Scientific customers may also use their FUNSTAR phantom with the Veriflux platform.
Intended User
The FUNSTAR/Veriflux and FUNSTAR Jr phantoms are 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 WARNING is given when the personal safety of the participant or a user can be affected. Disregarding this advice can cause an injury.
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 FUNSTAR/Veriflux and FUNSTAR Jr Phantoms
Functional Magnetic Resonance Imaging (fMRI) pushes the MRI scanner’s hardware to the limits of its performance, whilst demanding exceptional stability in order to detect small changes in blood oxygenation levels. For over 20 years MRI system stability for fMRI has been monitored using the fBIRN fMRI Quality Assurance Protocol[1], which specifies a phantom, imaging protocol, and analysis to quantify performance.
The FUNSTAR/Veriflux and FUNSTAR Jr are spherical gel stability phantoms designed to assess and monitor the accuracy, reproducibility, and stability of Magnetic Resonance Imaging (MRI) systems. These phantoms are specifically intended for evaluating the performance of functional Magnetic Resonance Imaging (fMRI) techniques and applications. They meet the requirements of a phantom for the fBIRN fMRI Quality Assurance Protocol[1].
The phantom consists of a synthetic polymer hydrogel housed within a HDPE spherical shell.
Dimensions
FUNSTAR/Veriflux: 180mm sphere
FUNSTAR Jr: 110mm sphere
Materials
Component | Materials Used |
|---|---|
Hollow Plastic Sphere | High Density Polyethylene (HDPE) |
Cap | Nylon, nitrile rubber |
Phantom liquid | Distilled Water, Sodium Chloride, Polyacrylamide, pH buffer (TRIS), Non-ionic surfactant, Manganese Chloride, Preservative (methylisothiazolinone and chloromethylisothiazolinone) |
WARNING: The phantom liquid is a mild irritant and may be skin sensitising. In the event of a leak or spill of the phantom liquid wear protective waterproof gloves when cleaning any spillages and dispose according to local regulations. See the safety data sheet for more information.
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 FUNSTAR/Veriflux or FUNSTAR Jr phantom 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 FUNSTAR/Veriflux and FUNSTAR Jr phantoms are supplied in a protective cardboard packaging box. To unpack:
Inspect the outer packaging. If any damage is present do not use the device. Please contact Gold Standard Phantoms.
Remove each component from the box.
Inspect each component for damage. If any damage is present do not use the device. Please contact Gold Standard Phantoms.
Carefully remove the outer packaging. Do not use a sharp knife in case this cuts or punctures the device.
WARNING: The FUNSTAR/Veriflux phantom weighs over 3 kg and will cause injury if dropped on bare feet or feet with open toed shoes. Take appropriate care when handling the phantom and wear suitable shoes that provide protection.
Use
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.
Align the MRI system’s laser with the middle of the phantom.
Move the phantom to magnet iso-centre.
Begin the MR examination.
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 FUNSTAR/Veriflux and FUNSTAR Jr phantom under a standard RMA (return merchandise authorisation). Shipping and Duty charges may apply.
Disposal
Do not allow the contents of the phantom to enter drains, sewers, or watercourses. Dispose of this material and its container as hazardous waste. Disposal should be in accordance with local, state, or national legislation.