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Prefilled Vials Instructions For Use
|
Gold Standard Phantoms |
Document ID: PD-3006-0012 |
| Revision | Summary | Date |
|---|---|---|
| 1.0 | First Issue | 28 Feb 2025 |
Foreword
These instructions for use contain all the information necessary to operate the Prefilled Vials in accordance with their 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 |
|---|---|
MR | Magnetic Resonance |
MRI | Magnetic Resonance Imaging |
MRS | Magnetic Resonance Spectroscopy |
Diffusion | Random movements of a molecule in an isotropic solution without thermal gradients. In MR typically this refers to the self-diffusion of water molecules. |
Relaxometry | Measurements of the MR relaxation times |
T1 | Longitudinal (spin-lattice) relaxation time constant |
T2 | Transverse (spin-spin) relaxation time constant |
D | Self-diffusivity of water |
Fat Fraction | The fraction of signal from fat protons (CH2, CH3) compared to water protons |
HDPE | High Density Polyethylene |
FKM | Fluorelastomer |
Introduction
About this Instruction Manual
The purpose of this instruction manual is to promote the safe use of the Prefilled Vials during their expected service life.
It describes the use of the device as intended by the manufacturer.
Identification
Product Name: Prefilled Vials
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 Prefilled Vials are plastic vials filled with reference materials for Quality Assurance measurements in Magnetic Resonance Imaging. The vials can be loaded into a corresponding phantom body from Gold Standard Phantoms, or used in isolation.
Intended User
The Prefilled Vials 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 the 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 Prefilled Vials
The Prefilled Vials are plastic vials filled with reference materials for Quality Assurance measurements in Magnetic Resonance Imaging. The vials can be loaded into a corresponding phantom body from Gold Standard Phantoms, or used in isolation. The vials come in three sizes:
Product Code | Nominal Capacity | Dimensions | Materials | Compatible Phantoms | Image |
|---|---|---|---|---|---|
10-DEL | 10 ml | 16 x 100 mm |
| MultiSample120E, SPIRIT |  |
15-FAL | 15 ml | 23 x 119 mm |
| MultiSample120S, MultiSample120D |  |
50-FAL | 50 ml | 35 x 115 mm |
| MultiSample190F |  |
MR Reference Materials
The prefilled vials are filled from a range of reference materials:
Type | Product Code | Description | SI Traceable Characterisation Available |
|---|---|---|---|
Relaxometry | MNCL-0017 | 0.017mM Aqueous MnCl2 | T1, T2 |
Relaxometry | MNCL-0027 | 0.027mM Aqueous MnCl2 | T1, T2 |
Relaxometry | MNCL-0039 | 0.039mM Aqueous MnCl2 | T1, T2 |
Relaxometry | MNCL-0055 | 0.055mM Aqueous MnCl2 | T1, T2 |
Relaxometry | MNCL-0078 | 0.078mM Aqueous MnCl2 | T1, T2 |
Relaxometry | MNCL-0110 | 0.110mM Aqueous MnCl2 | T1, T2 |
Relaxometry | MNCL-0159 | 0.159mM Aqueous MnCl2 | T1, T2 |
Relaxometry | MNCL-0194 | 0.194mM Aqueous MnCl2 | T1, T2 |
Relaxometry | MNCL-0245 | 0.245mM Aqueous MnCl2 | T1, T2 |
Relaxometry | MNCL-0320 | 0.320mM Aqueous MnCl2 | T1, T2 |
Relaxometry | MNCL-0480 | 0.480mM Aqueous MnCl2 | T1, T2 |
Relaxometry | MNCL-0630 | 0.630mM Aqueous MnCl2 | T1, T2 |
Diffusion | PVP-0000 | 1mM Aqueous NiCl2 | T1, T2, D |
Diffusion | PVP-0025 | 2.5% Aqueous PVP NiCl2 | T1, T2, D |
Diffusion | PVP-0050 | 5% Aqueous PVP NiCl2 | T1, T2, D |
Diffusion | PVP-0100 | 10% Aqueous PVP NiCl2 | T1, T2, D |
Diffusion | PVP-0150 | 15% Aqueous PVP NiCl2 | T1, T2, D |
Diffusion | PVP-0200 | 20% Aqueous PVP NiCl2 | T1, T2, D |
Diffusion | PVP-0250 | 25% Aqueous PVP NiCl2 | T1, T2, D |
Diffusion | PVP-0300 | 30% Aqueous PVP NiCl2 | T1, T2, D |
Diffusion | PVP-0400 | 40% Aqueous PVP NiCl2 | T1, T2, D |
Diffusion | PVP-0500 | 50% Aqueous PVP | T1, T2, D |
Fat Fraction | FFP-005 | Peanut Oil Emulsion 5% Fat | |
Fat Fraction | FFP-010 | Peanut Oil Emulsion 10% Fat | |
Fat Fraction | FFP-015 | Peanut Oil Emulsion 15% Fat | |
Fat Fraction | FFP-020 | Peanut Oil Emulsion 20% Fat | |
Fat Fraction | FFP-025 | Peanut Oil Emulsion 25% Fat | |
Fat Fraction | FFP-030 | Peanut Oil Emulsion 30% Fat | |
Fat Fraction | FFP-035 | Peanut Oil Emulsion 35% Fat | |
Fat Fraction | FFP-040 | Peanut Oil Emulsion 40% Fat | |
Fat Fraction | FFP-045 | Peanut Oil Emulsion 45% Fat | |
Fat Fraction | FFP-050 | Peanut Oil Emulsion 50% Fat | |
Fat Fraction | FFP-055 | Peanut Oil Emulsion 55% Fat | |
Fat Fraction | FFP-100 | Peanut Oil | |
Fat Fraction | TB-090 | 90% CH Molar Fraction Aqueous t-Butanol | |
Fact Fraction | TB-075 | 75% CH Molar Fraction Aqueous t-Butanol | |
Fat Fraction | TB-010 | 10% CH Molar Fraction Aqueous t-Butanol | |
MR Spectroscopy* | Contains a mixture of metabolites at varying concentrations. See the SPECTRE Phantom for possible metabolites. | ||
Gel* | Contains natural or synthetic hydrogels |
*MR Spectroscopy and Gel vials are custom ordered. Please contact Gold Standard Phantoms for more information.
Traceability
Each vial is labelled with a unique identification code which is traceable to the batch of liquid within the vial. Records are made during manufacture of this liquid identifying the components, the quantities added of each component, and their batch numbers which are traceable to their suppliers. In addition this traceability extends to any characterisation performed on batches of materials.
SI Traceable Characterisation
Relaxometry (MNCL-XXXX) and Diffusion (PVP-XXXX) materials come from batches of where a sample has had SI-traceable characterisation performed on it:
Relaxometry: characterised for proton relaxation times (T1, T2) at 3.0 T and specified temperatures, in accordance with NIST SP 250-97[1].
Diffusion: characterised for proton relaxation times (T1, T2) and the self-diffusivity of water (D) at 3.0 T and specified temperatures, in accordance with NIST SP 250-100[2].
Characterisation data is supplied, comprising values and uncertainties for each measurand and condition, for comparison against measurements made on their MRI systems. To request a copy of the characterisation data, please contact Gold Standard Phantoms.
CAUTION: Prefilled vials are certified for two years. After this point they cannot be guaranteed to match the SI-traceable characterisation values, and should be replaced with a new set to maintain certification.
Composition
The MR Reference Materials have the following compositions:
Product Code | Type | Composition |
|---|---|---|
MNCL-XXXX | Relaxometry | Distilled water, Manganese(II) Chloride, Preservative (methylisothiazolinone and chloromethylisothiazolinone) |
PVP-XXXX | Diffusion | Distilled water, Polyvinylpyrrolidone k-30, Nickel(II) Chloride, Preservative (methylisothiazolinone and chloromethylisothiazolinone) |
FFP-XXX | Fat Fraction | Distilled water, Peanut oil, Emulsifiers (non-ionic surfactants), Manganese chloride, Preservative (methylisothiazolinone and chloromethylisothiazolinone) |
TB-XXX | Fat Fraction | Distilled water, t-Butanol, Preservative (methylisothiazolinone and chloromethylisothiazolinone) |
N/A | MR Spectroscopy | Distilled Water, Potassium Phosphate Monobasic, Sodium Hydroxide, N-Acetyl-L-aspartic acid, Creatine, Choline Chloride, Myo-Inositol, L-Glutamic acid, L-Lactic acid lithium salt, Gamma-Aminobutyric Acid, Preservative (methylisothiazolinone and chloromethylisothiazolinone), Gadolinium DTPA Sodium Salt |
WARNING: The contents of the Prefilled Vials is a mild irritant and may be skin sensitising. In the event of a leak or spill of the 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 Prefilled Vials 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. When not inside the Phantom, store in the supplied box on a flat surface such as a shelf.
Cleaning
If the Prefilled Vials require cleaning they 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 surface; however, these may cause the labels to stop adhering to the surface.
Operating Instructions
For operating instructions please refer to the relevant instructions for use of the device that the Prefilled Vials are to be used with.
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 Prefilled Vials carry as 1 year manufacturer’s warranty. This covers assurance regarding quality / lifespan with a promise to repair or replace the Prefilled Vials 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.
Citations
- ^ M. A. Boss et al., “Magnetic resonance imaging biomarker calibration service: proton spin relaxation times,” National Institute of Standards and Technology, May 2018. doi: 10.6028/nist.sp.250-97.
- ^ M. A. Boss et al., “Magnetic resonance imaging biomarker calibration service :,” National Institute of Standards and Technology (U.S.), Oct. 2022. doi: 10.6028/nist.sp.250-100.