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MultiSample120E Instructions For Use
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Gold Standard Phantoms |
Document ID: PD-3000-6001 |
Foreword
These instructions for use contain all the information necessary to operate the MultiSample120E 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 |
|---|---|
Accessory port | Threaded opening (M12x1.5 in this device) that allows accessories such as fibre-optic temperature probes to be attached to the phantom. |
Adverse event | Any unintended or unfavourable medical occurrence associated with the use of the device, which should be reported to Gold Standard Phantoms and the relevant authority. |
B0 | The main static magnetic field of an MRI scanner; good B0 homogeneity means the field is very uniform across the imaging volume. |
BSP | British Standard Pipe; a family of screw thread standards used for pipe fittings, such as the G1/4 filling ports on the phantom. |
Coil loading | The effect of placing an object (such as a phantom) in an MRI radiofrequency (RF) coil, which changes the electrical properties and tuning of the coil. |
Diffusion (MRI) | An MRI technique that measures the random (Brownian) motion of water molecules in tissues or samples, often used to derive diffusion-related parameters. |
Enclosure Lid | The upper part of the MultiSample120E enclosure that seals the main body and supports the Sample Holder and associated fixings. |
Fibre-optic temperature probe | A temperature sensor that uses optical fibres instead of metal conductors, making it non-magnetic and safe for use in an MRI environment. |
Fiducial marker | A physical reference feature used to aid positioning and alignment; in this device, NMR tube fiducials act as markers visible in imaging. |
Filling port | A threaded opening (G1/4 BSP on this device) used to fill or empty the main chamber with liquid. |
Flood fill liquid | The liquid used to completely fill the main chamber of the phantom to provide background signal, susceptibility matching and appropriate coil loading. |
Fluoroelastomer | A family of synthetic rubbers with high chemical and heat resistance, used in seals such as vial caps. |
G1/4 thread | A specific BSP (British Standard Pipe) thread size used for the filling ports on the MultiSample120E. |
HDPE | High Density Polyethylene; a durable plastic used for the vial caps in this device. |
Liquid crystal thermometer | A temperature indicator that uses thermochromic liquid crystals; it changes colour with temperature and is attached to the phantom’s outer surface. |
M12x1.5 thread | A metric screw thread with 12 mm outer diameter and 1.5 mm pitch, used for the accessory ports. |
Metabolic imaging | MRI-based techniques that measure or infer metabolic processes (e.g. via spectroscopy or specialised contrast) within samples or tissues. |
MRI | Magnetic Resonance Imaging; a non-invasive imaging technique that uses strong magnetic fields and radiofrequency pulses to generate detailed images. |
Multi-nuclear imaging | MRI techniques that image nuclei other than hydrogen (¹H), such as phosphorus (³¹P) or sodium (²³Na), to obtain additional biochemical or physiological information. |
MultiSample120E | The specific 120 mm diameter cylindrical MRI phantom described in this document, designed to hold multiple sample vials for advanced MRI applications. |
Newton metre (Nm) | The SI unit of torque used for setting the torque screwdriver (e.g. 0.4 Nm, 0.8 Nm, 1.2 Nm). |
Nitrile rubber | A synthetic rubber resistant to oils and many chemicals, used for seals such as O-rings. |
NMR | Nuclear Magnetic Resonance; the underlying physical phenomenon on which MRI is based, also used more generally for spectroscopy of samples. |
NMR tube fiducials | NMR tubes built into the Sample Holder that act as fiducial markers, providing visible reference points in NMR/MRI images for alignment and calibration. |
O-ring | A circular elastomeric ring used as a gasket to create a fluid-tight seal between mating surfaces, such as between the Enclosure Lid and main body. |
Phantom | A specially designed object that mimics certain physical or imaging properties of tissue, used to test, calibrate and perform quality assurance on MRI scanners. |
Polyamide | A class of engineering plastics (often known as nylon) used here in glass-filled form for high-strength screws and components. |
Polycarbonate | A strong, transparent engineering plastic used to manufacture the main body and Sample Holder of the MultiSample120E. |
Polypropylene | A chemically resistant plastic used to manufacture the sample vials and some caps in the MultiSample120E. |
Quantitative T1/T2 relaxometry | MRI techniques that measure the T1 and T2 relaxation times numerically (in milliseconds), providing quantitative maps rather than just weighted images. |
Radiographer / MRI Technologist | A healthcare professional trained to operate MRI scanners and acquire clinical or research images safely and correctly. |
RMA | Return Merchandise Authorisation; a formal process for returning a product for repair, replacement or inspection under warranty. |
Sample Holder | The component inside the phantom that securely holds the vials (and NMR tube fiducials) in a defined, reproducible arrangement. |
Sample Holder Retaining Plate | The plate that clamps the vials in place within the Sample Holder, secured by screws and aligned using the fiducial markers. |
SMW | Standard Manufacturer’s Warranty; the warranty provided by Gold Standard Phantoms for the device, covering repair or replacement under specified conditions. |
Susceptibility matching | Adjusting the magnetic properties of the background medium (e.g. flood fill liquid) so that its magnetic susceptibility closely matches that of the samples, improving B0 homogeneity. |
T1 relaxation time | The time constant describing how quickly longitudinal magnetisation recovers towards equilibrium after an RF pulse in NMR/MRI. |
T2 relaxation time | The time constant describing how quickly transverse magnetisation decays due to spin–spin interactions in NMR/MRI. |
Torque screwdriver | A screwdriver with a built-in clutch that slips (and usually clicks) once a preset torque is reached, ensuring screws are tightened to a controlled torque. |
Vial | A small cylindrical container (here, 100 × 16 mm, 10 ml polypropylene tubes) used to hold individual samples within the phantom. |
Vial location key card | A reference card that shows the numbering and positions of the vials in the Sample Holder to ensure consistent sample placement and documentation. |
Introduction
About this Instruction Manual
The purpose of this instruction manual is to promote the safe use of the MultiSample120E during its expected service life. It describes the use of the device as intended by the manufacturer.
Identification
Product Name: MultiSample120E
Model: MS120E
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. |
EU Authorised Representative Email Address |
Intended Use
The MultiSample120E is intended to be used for quality assurance of Magnetic Resonance Imaging Scanners (MRI). The MultiSample120E allows consistency of image quality and scanner performance over time. The MultiSample120E is also intended for the development of protocols and pulse sequences. This provides a stable, repeatable and controlled environment for testing new sequences and parameters.
Intended User
The MultiSample120E is intended for use by scanner operating personnel. The device must be used by competent personnel who has the applicable education and experience. This includes but is not limited to:
Radiographer/MRI Technologist
Clinical Scientist/Hospital Physicist
MRI Physicist
Radiologist
Students/Researcher
Other trained Medical Professional
This 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
About Warnings and Cautions
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 patient 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.
Device Description
About the MultiSample120E
The MultiSample120E is a 120mm diameter cylindrical phantom designed for use in an MRI scanner. The MultiSample120E is capable of holding up to 24 industry standard 100 x 16mm, 10ml polypropylene vials. It addresses the need for a standardised container for multiple sample vials when preparing phantoms in-house for advanced MRI techniques.
Applications include:
• Quantitative T1/T2 relaxometry
• Metabolic imaging
• Spectroscopy
• Multi-nuclear imaging
• Diffusion
• Fat fraction
The MultiSample120E can be supplied:
Empty, for the customer to fill as required.
With pre-filled vials.
With pre-filled vials, in a defined configuration, and with the main chamber filled.
The main body and sample holder of the MultiSample120E are made from polycarbonate. The sample vials and caps are made from polypropylene, with fluoroelastomer seals.
Materials
Component | Materials Used |
|---|---|
Main Body and Sample Holder | Polycarbonate, Nylon, Nitrile rubber |
Vials and caps | Polypropylene, Fluoroelastomer |
Phantom liquid | Distilled Water, Manganese (II) Chloride, Surfactant (C8-18 Ethoxylated Propoxylated), and preservative (methylisothiazolinone and chloromethylisothiazolinone) |
Storage Instructions
Store
In a dry and well-ventilated environment
Between 15 °C and 30 °C
Out of direct sunlight
Handling Information
The MultiSample120E should be handled with care to prevent damage.
If supplied pre-filled, take care to avoid spilling of the liquid contents. Avoid contact with skin, eyes or clothing.
WARNING: Contents of Phantom may irritate the skin. In the case of contact with skin, wash well with water. Remove any contaminated clothing and wash clothing before reuse.
If skin irritation occurs, seek medical advice/attention.
Cleaning
If the MultiSample120E 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 exterior of the phantom, however these may cause the labels to stop adhering to the surface.
Unpacking the Equipment
The MultiSample120E box contains:
MultiSample120E
Vial location key card
Adjustable Torque Screwdriver
Stainless Steel Hex Bits (5mm and 6mm)
Spare Fixings
MultiSample120E Components
MultiSample120E Main Body
Sample Holder attached to Enclosure Lid
G1/4 BSP Filling Ports
M12x1.5 Accessory ports
NMR Tube Fiducials
Controls and Indicators
The temperature of the Phantom can be monitored using the included liquid crystal thermometer:
Note: The liquid crystal thermometer indicates the temperature of the outer surface of the phantom, and not the internal temperature. It provides an indication of the temperature, but should not be relied on for accurate temperature measurements.
Fibre-optic temperature probes can be inserted via the M12x1.5 Accessory Ports.
Operating Instructions
Torque Screwdriver
The torque screwdriver has a clutch that slips when a torque above the set value is encountered.
When the clutch slips it makes an audible click, indicating that the screw has been tightened to the correct torque.
When loosening screws the clutch will not slip, regardless of the torque setting
WARNING: The supplied torque screwdriver and stainless steel bits are made from steel and are magnetic. They should not be brought into the MRI scan room as they present a projectile hazard.
CAUTION: all screws must be tightened using the supplied torque screwdriver, with the torque correctly set as advised. Failing to do so may cause damage to the MultiSample120E.
The torque screwdriver has a clutch that slips when a torque above the set value is encountered. When the clutch slips it makes an audible click, indicating that the screw has been tightened to the correct torque.
When loosening screws the clutch will not slip, regardless of the torque setting.
To set the torque of the screwdriver, push the adjustment ring down, and rotate the body of the screwdriver.
The torque setting is indicated with the white arrow.
Accessing the MultiSample120E Vials
To access the vials, follow the step-by-step instructions below:
The sample holder must be removed from the main body. The ten screws on the outer edge of the Enclosure Lid must be unscrewed using the Torque Screwdriver and 5mm Stainless Steel Hex Bit.
Once all then screws have been removed and placed in a safe place, separate the Enclosure Lid and attached Sample Holder, from the main body as shown in the image.
2. To remove the vials from the holder, four screws must be removed from the Sample Holder Retaining Plate as seen below. This should be done with the Torque Screwdriver and 5mm Stainless Steel Hex Bit. Once this has been done, the Sample Holder retaining plate can be removed, allowing access to the vials.
Assembling the MultiSample120E
To assemble the MultiSample120E, fit the Sample Holder Retaining Plate to the Sample Holder. Ensure that the NMR tube fiducials on the Sample Holder align with the two black circles on the Retaining Plate as seen in Figure below.
Fit the four polycarbonate screws and tighten using the Torque Screwdriver and 5mm Stainless Steel Hex Bit. The Torque Screwdriver should be set to 0.4Nm.
3. Place the Sample Holder back into the main body of the MultiSample120E.
4. To align the Sample Holder correctly with the main body of the MultiSample12E, ensure that the filling ports are aligned to logo sticker on the main body. The accessory ports should be facing to the left as seen in the figure below.
5. Before fitting the screws, ensure the O-ring is placed within the groove.
6. The MultiSample120E lid is fixed using ten glass filled polyamide M6 screws which are located on the outer edge of the lid. Screws should be hand fitted and tightened using the Torque Screwdriver and 5mm Stainless Steel Hex Bit. The Torque Screwdriver should be set to 0.8Nm.
7. First tighten Screws in the lid should be tightened in opposite pairs: an example can be seen in the figure below.
8. Once tightened, this process should be repeated to maintain tightness of the screws.
Filling the MultiSample120E main chamber
The main chamber of the phantom can be “flood filled” filled with an appropriate liquid during scanning to ensure:
good susceptibility matching between the sample and the background, optimising B0 homogeneity.
background signal
coil loading.
There are two G1/4 BSP filling ports in the lid to facilitate filling. These have solid polyamide screw-in caps with a 6mm hex socket. To fill and cap:
Unscrew both filling ports, using the supplied Torque Screwdriver and 6mm Stainless Steel Hex Bit.
Fill the chamber with the chosen flood fill liquid. A funnel (not supplied) can help here. Fill as much as possible.
Cap both filling ports (hand tight), then invert the phantom to move any residual bubbles to the end of the chamber. Allow any small bubbles to coalesce into larger bubbles.
Turn the phantom right-side-up. Open one of the filling caps.
Tilt the phantom so that the open fill port is raised up. Any bubbles will travel to this port.
Top-up the liquid until the chamber is completely full. A syringe or pipette can help here. Fill until the liquid is at the top of the filling port.
Re-fit the cap, and screw down so that the port is sealed but the torque screwdriver does not click.
Dry any residue around the port.
Check that there are no bubbles in the chamber. If satisfied both ports can not be fully tightened to 1.2Nm.
Note: Polycarbonate plastic is permeable to water vapour. Over time air bubbles may appear in the main chamber due to evaporation of water, so periodic topping up is recommended.
Temperature Monitoring
The MultiSample120E can be fitted with two fibre optic probes.
To do this, remove the two M12x1.5 accessory ports and fit the probes.
Recommended orientation during scanning
The recommended orientation for the MultiSample120E during scanning is given below:
The MultiSample120E logo is placed facing upwards.
The filling ports should be facing downwards and to the right.
Vials should be orientated in clockwise rotation (front view) as seen on vial location key card.
Adverse Events
Any adverse incidents that occur in relation to this device should be reported 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 MultiSample120E under a standard RMA (return merchandise authorisation). Shipping and Duty charges may apply.
Disposal
Any pre-filled contents of the MultiSample120E should not be allowed to enter drains, sewers, or watercourses. Dispose of these materials as hazardous waste, in accordance with local, state, or national legislation.
