Report05019

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ONI Medical Systems. OrthOne® 1 T MR imaging system
Technical Report · April 2005

DOI: 10.13140/RG.2.2.20532.58245
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MHRA
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April 2005
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Report 05019
ONI OrthOne® 1 T
MR imaging system
Department of Health
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best choice • best practice www.mhra.gov.uk nww.medical-devices.nhs.uk

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ONI Medical Systems
OrthOne® 1 T
MR Imaging System
Janet De Wilde, David Price,

James Williams, Ioannis Delakis, Caroline Renaud
MagNET
Director: Richard I. Kitney OBE
Department of Bioengineering
Imperial College London
Exhibition Road
London
SW7 2AZ
T: 020 7594 6305

E: enquiry@magnet-mri.org
www.magnet-mri.org
© Crown Copyright 2005

Apart from any fair dealing for the purposes of research or private study, or criticism, or review,
as permitted under the Copyright, Designs & Patents Act, 1988, this publication may only be
reproduced, stored or transmitted in any form or by any means with the prior permission, in
writing, of the Controller of Her Majesty's Stationery Office (HMSO).
Information on reproduction outside these terms can be found on the HMSO website
(www.hmso.gov.uk) or email: hmsolicensing@cabinet-office.x.gsi.gov.uk.
The MHRA is an executive agency of the Department of Health
ISBN 1- 84182 950 1

Contents
Summary 1
Introduction
Scope, structure and MHRA 2
Conformity with standards and EC directives 3
Details of assessment 3
Key reference 3
Description 4
System specification
Magnet and gradient system 6
Computer system 9
Patient handling 11
Operator console 13
Radio-frequency (RF) coils 19
Sequences and packages 20
Technical evaluation
Acoustic noise 23
Emergency systems 24
List of safety information 25
Introduction to evaluation 28
180 mm coil evaluation 29
123 mm coil evaluation 43
Functionality evaluation 51
Conclusion
Technical summary tables 55
Overall comments on technical performance 56
Acknowledgements 57
Appendix
Manufacturer’s comments 58
Manufacturers QA method 59
Background information 60
Contact details 61
Clinical fast sequences used for evaluation 62
More information including details of evaluation protocols, test objects

and other reports can be found at www.magnet-mri.org
05019: ONI OrthOne® 1T
Summary
This report provides a detailed evaluation of ONI Medical Systems

OrthOne® 1 T dedicated extremity MRI. The MagNET team went to the New
England Baptist Hospital, Boston, USA, to perform a technical assessment of
the system. This report contains the results of that evaluation. It also
incorporates detailed specifications of the system.
The following paragraphs comment on the overall technical performance of this

scanner relative to the average performance of whole body 1 T systems
evaluated by MagNET using quadrature head RF coils. The average 1 T data
are provided for indicative purposes rather than for direct comparison since the
OrthOne® is a small bore extremity scanner.
Measured parameters with outstanding performance levels for a 1 T system

were:
• 180 mm coil SNR

• 180 mm coil uniformity
• 123 mm coil SNR*
• 123 mm coil uniformity*
• 180 mm coil ghosting performance (for both 1 and 2 NSA for the 1st
echo of the dual echo sequence†).
Measured parameters with performance levels as expected for a 1 T system

were:
• 180 mm coil resolution performance

• geometric linearity
• 3 mm and 5 mm slice widths for the 180 mm coil and the 123 mm coil
(transverse plane).
Measured parameters with performance levels below average for a 1 T system

were:
• 180 mm coil ghosting performance (for both 1 and 2 NSA for the 2nd
echo of the dual echo sequence†)
• 2D and 3D imaging speed.
* Not directly compared with 1 T average because of small coil size but high results for SNR and uniformity
†
Two dual echo sequences were used instead of a single four echo sequence. See manufacturer’s
comments for explanation of result.
1
Introduction
Scope, structure and MHRA

Scope
This report combines system specifications, user information, safety and
technical evaluation results to provide a comprehensive overview of a particular
MR system. There are other factors, outside the scope of this report, which
should be taken into account in purchasing decisions. For information on capital
and operating costs, maintenance, safety and peripheral equipment please
contact MagNET.
The technical assessment aims to obtain type-test measurements of imaging

performance. Type-testing is the evaluation of one machine, identified by the
manufacturer as operating to specification, that is taken to be representative of
that model. The measurements enable a comparison with different type-tested
MRI systems. The technical evaluation is normally carried out at a factory site
with the full cooperation of the manufacturer. In special circumstances, where
resources are available, the evaluation may be carried out at a clinical site. The
results are necessarily scientific and are intended as a guide to imaging
performance.
This report does not attempt to explain MRI. Readers who are unfamiliar
with this modality may have difficulty understanding the results presented
in this report. In this case, advice should be sought from a suitably
qualified specialist.
Structure
The summary section of this report comprises an executive summary of
technical evaluations findings.
The main body of the report is divided into two sections. The first presents the
system specifications, system information and safety evaluation, and the
second gives the technical evaluation results. The conclusion section includes
tables that compare the technical test results with the average values of
systems with similar magnetic field strengths, as well as overall comments on
the performance of this system. The results contained in this report are
published after consultation with the manufacturer. Their comments are
included in the Appendix.
Additional information is obtainable from the website www.magnet-mri.org

2
Introduction
MHRA
The Medicines and Healthcare products Regulatory Agency (MHRA), an
executive agency of the Department of Health, was created on 1 April 2003
from the merger of the Medical Devices Agency and the Medicines Control
Agency. Further details are available in the Appendix and on the agency’s
website: www.mhra.gov.uk
Conformity with standards and EC directives

Table 1: Quality assurance of manufacturing sites
Accredited Standards Accreditation Information
ISO 13485:1996 Notified Body TUV 0123
EN ISO 13485:2000 Q1Z 04 06 52526 001
DIN EN ISO 13485:2001 Date: 2004-06-28
ISO 9001:1994
EN ISO 9001:1994
DIN EN ISO 9001
Table 2: Equipment conformity with international standards

Accredited Standards Accreditation Information
EN/IEC 60601-1:88 +A1:91+A2:95 Entela Report 040429418
EN/IEC 60601-2-33:2002 Entela Report 040429418
EN/IEC 60601-1-1:2000 Entela Report 69781
EN/IEC 60601-1-2: 2001 Entela Report 69781
CE marked under MDD directive Notified Body TUV 0123
G1 04 06 52526 002
Date: 2004-06-25
Details of assessment
Table 3: Technical assessment
Site Date of assessment
New England Baptist Hospital, Boston, USA 23 July 2004
Capio Ullevål Stadion, Oslo, Norway 11 February 2005
Key reference
Table 4: MR model abbreviation codes for 1 T systems
Manufacturer Model Code
05019: ONI OrthOne® 1 T
ONI OrthOne® ON-ORT

Various Whole body/Head coil MEAN-1T-WB
3
Description
The ONI OrthOne® 1 T, shown in Figure 1, is a dedicated extremity scanner

designed for studies of the hand, wrist, elbow, foot, ankle and knee. It has
dimensions (including covers) of 56 cm x 77 cm x 147 cm (depth x width x
height) and has a total mass of 0.64 tonnes. The minimum installed area is
15.3 m2. The radial 0.5 mT fringe field (xy) is 1.25 m from the isocentre whilst
the axial fringe field (z) is at 1.8 m from the isocentre. The patient aperture is
determined by the coil fitted. The minimum aperture is 12.3 cm (diameter) whilst
the maximum is 18.0 cm (diameter).
Figure 1. ONI OrthOne® scanner

4
Introduction
The system features a separate adjustable patient couch to allow the

introduction of the limb to be scanned into the bore at a height of 53 cm. The
width of the couch is 57 cm and its body mass limit is 158.5 kg. A padded
movable ottoman to support the leg or arm during imaging is available as an
option.
The gradient system features a maximum amplitude of 15 mT/m and a slew rate
of 60 mT/m/ms.
The host computer system now features a single Pentium IV computer with
HyperThreading Technology running Windows XP (embedded). The system
features a CPU speed of 2.8 GHz giving a reconstruction speed of 5 2562
images per second (full FOV) and 1024 MB RAM main memory.
The RF system features a single independent RF receiver channel with variable

bandwidth of 0.005-0.100 MHz. The channel’s analogue-to-digital converter has
a sampling frequency of 8 MHz.
The RF hardware consists of removable quadrature volume transmit- receive

coils. There are two coils available as standard, the Upper Extremity coil with an
internal diameter of 180 mm and the lower extremity coil with a diameter of 123
mm. The EXTREME high SNR coil with a diameter of 160 mm is available as an
option for the imaging of smaller knees, large hands and elbows.
A standard set of imaging sequences is provided for extremity imaging. This

consists of 2D/3D SE, 2D/3D FSE, 2D/3D GE, 2D SE-IR and 2D FSE-IR. Short
Tau IR and True IR are also available.
5
Specification data are those from the MHRA reports indicated and were correct
at the time of going to press (subsequent updates or newer versions from the
manufacturers are not accounted for).
Table 5: Magnet specification

Manufacturer/Model Gradient system Field strength Report no.
ONI Medical Systems, - 1T 05019
Inc./OrthOne® 1T
Magnet and gradient system

Table 6: Magnet specification
ONI
RF frequency MHz 42.6 (± 500 kHz)
Shielding Passive, self-shielded (magnetic)
Homogeneity (VRMS) 40 cm DSV ppm ±10 ppm over 150 mm diam. radial x 120 mm
axial ellipsoid volume
Field stability ppm/hr < 0.1
Number of measurement planes 15
Number of measurement points 24
Cooling system Liquid helium with air cooled compressor
Boil-off rate l/hr Negligible
Helium refill Not normally required
Table 7: Shimming details

ONI
Passive on installation Yes
Number of shim plates 24 trays; 31 pockets/tray
Active with patient in position Yes; linear x, y, z terms automatic under
operator control
Number of independent channels 3 - x, y, z
6
Table 8: Patient comfort details

ONI
Patient aperture at narrowest: Width cm 12.3
Length cm 56
Height (floor to isocentre) cm 58.5
Patient aperture at maximum: Width cm 18.0
Height (floor to isocentre) cm 58.5
Length with covers cm 56
Patient couch: Min. height cm 53
Max. height cm 53
Table top width cm 57
Body mass limit (full movement) kg 158.5
Table 9: Installation details

Overall scanner dimensions ONI
Mass: magnet only tonnes 0.5
Mass: assembly tonnes (including couch) 0.64 (0.72)
Depth with covers (z) cm 56
Width with covers (x) cm 77
Height with covers (y) cm 147
Radial (x, y) 0.5 mT fringe field m 1.25
Axial (z) 0.5 mT fringe field m 1.8
2
Minimum installed area m * 15.3 – 23.2
Minimum ceiling height cm * 234
*To include 0.5 mT fringe field
Table 10: Electronics cabinets

Cabinets ONI
Number 2
Total width cm 112
Maximum depth cm 81.2
Maximum height cm 96.5
Cooling system Air cooled helium
compressor
7
Table 11: RF system specification

ONI
Name/type/version of the system Removable quadrature volume
transmit & receive
Number of independent RF receiver channels 1
Bandwidth of each independent RF receiver channel 0.005 - 0.100; variable
(MHz)
Number of analog-to-digital converters for each 1
independent RF channel
Sampling frequency of each analog-to-digital converter 8
(MHz)
Table 12: Gradient system specification

ONI
Gradient system Not separately named
Shielding Active
Single axis maximum amplitude (x, y, z) mT/m 15
Single axis maximum slew rate (x, y, z) mT/m/ms 60
Duty cycle at max amplitude % 100
Amplitude @100% duty cycle mT/m 15
Figure 2. Image of the left knee acquired with the 180 mm quadrature coil
8
Computer system
Table 13: Main computer system - architecture
ONI
Type Single Pentium IV with HyperThreading
Technology
Operating system Windows XP (Embedded)
CPU GHz 2.8
Word length bit 32
Memory size MB 1024 RAM
Hard disk: Removable
Software GB 80
Hard disk:
Images GB 2
2
Image capacity 512 images 4000
(uncompressed)
Archive Drive
Size MB 9626 (4813/side)
2
Image capacity 256 images 59,000
(uncompressed)
Table 14: Main computer system – image processor

ONI
Manufacturer and type Intel “Pentium IV”
Processing speed GHz 2.8
Word length bit 32
Memory size bulk array GB 1
2
Number of 256 image reconstructed per sec 5
(True 256 x 256 matrix, no interpolation, no
rectangular matrix, no rectangular FOV)
Transfer rate from host MB/s 128
Table 15: Image display monitor

Parameter ONI
Screen size in 19
Type (BW / colour) Colour-TFT
Matrix size 1280 x 1024
Bit depth bit Not known
9
Table 16: Networking

Parameter ONI
Interface standard support
for HIS DICOM 3
for PACS DICOM 3
for workstation DICOM 3 (Send/receive/query)
Physical interface standard Ethernet
All system peripherals networked? Yes
Video interface availability No
Table 17: Independent console

Parameter ONI
Manufacturer and type No independent console available
Table 18: Resolution parameters

Parameter ONI
Minimum FOV mm 40
Maximum imaging matrix 512 x 512
Minimum 2D slice thickness mm 2.0
Minimum 3D slice thickness mm 0.5
Table 19: Speed parameters

Parameter Sequence ONI
Minimum TR ms Spin echo* 18
Minimum TR ms 2D gradient echo* 9
Minimum TR ms 3D gradient echo* 12
Minimum echo spacing ms Turbo spin echo* 10.2
†
Minimum echo spacing ms Echo planar imaging Not available
Minimum TE ms Single-shot diffusion imaging Not available
with b-value of 1000 mm2/s†
*For 256x256 matrix with no interpolation.
†
For 128x128 matrix with no interpolation.
10
Patient handling
Table 20: Patient comfort
Feature User information
Magnet design Superconducting with open bore
View of patient from console Straight ahead (patient head external to magnet)
Patient accessibility during
Patient head & trunk external to magnet during scanning
scanning / positioning
Bore lighting Not required (patient head external to magnet during
scanning)
Bore ventilation Not required
Patient intercom Customer supplied
Music system Customer supplied
Panic button Not required (patient head visible to technologist during
scanning)
Closed circuit TV Customer Supplied
Table 21: Gantry control panel

Position of control panel Not required
Controls Not required
Position indicator External laser position indicator
Landmarking lights At bore entrance
Alignment at isocentre By “Scout” imaging or measurement using external laser
position Indicator
To recall landmark Not applicable
Figure 3. Patient positioning for knee imaging and wrist imaging

respectively
11
Table 22: Cable connectors

RF coil connectors Self-aligning pin type with blind mate
Gating connectors Not applicable
Patient alarm connectors Not applicable
Table 23: Patient couch specification

Couch type Patient chair - adjustable
Table top width 57 cm - chair
Body mass limit 158 kg
Horizontal movement Not applicable
Vertical movement and height
Not applicable
range
Table top release Not applicable
Table 24: Accessories

Function Type* Accessory
Immobilisation, support S
Standard sponge set (8); “Ergo” patient ottoman
and positioning devices
*Type code: S = standard, O = optional.
12
Operator console
Table 25: Operator console – configuration
Key components User information
Console PC Based
Keyboard Standard QWERTY computer keyboard
Mouse 2 button mouse with centre wheel
Software Windows XPe, Cedara & ONI-MSI V2.0
Figure 4: View of ONI OrthOne® keyboard & 19” LCD*
* mouse not shown, power control unit not shown, emergency quench control not shown, computer table
not part of system.
13
Table 26: Operator console – features

Console features User information
General features Menu-driven software architecture with pull down menus, task
cards, status bar, image review and selection, patient list. Multi-
tasking
System status Remaining scan time, active patient name and D.O.B., scan control,
information SAR level, scan queue, anatomy selection card, protocol selection
card
Patient details Yes. DICOM “Worklist” supported (optional item)
Scan parameters All displayed and operator selectable
Using set protocols Pre-set and operator selectable
Changing set protocols Yes. New sets can be saved for future use.
Conflicts alert Yes. Scan cannot be initiated until re-set with acceptable
parameters.
Scout/Localisation Yes. Three plane
Positioning slices Active graphical slice selection and positioning
Batch image sequencing Yes
Advance planning Yes
Pause scan Yes
Coil tuning Not required. Coils are factory tuned
Raw data availability Yes
Image archiving Yes
Image retrieval Yes
Image hard-copy Yes via filming tab
Programming language Visual C++ V6.0 (Not accessible to standard user)
Software packages No options available
14
Table 27: Operator console – multi-tasking

Image tasks Run at same time as data acquisition?
Image reconstruction Yes but the reconstruction must finish before a new acquisition
can be started
Image display Yes
Image archiving Yes
Image retrieval Yes
Image hardcopying Yes
Other tasks (specify) Image analysis available from operator’s console
Table 28: Image display

Image presentation User information
General features Complete image selection, viewing, W/L and magnification
changes plus image annotation
Screen configurations 1/1, 2/1, 4/1, 9/1, 12/1, 16/1 preset, user selectable
Image paging/scrolling Yes
Simultaneous studies Yes. Multiple sequence display with side-by-side imaging
Cine display Yes. Looped and yoyo mode
Image windowing User information
Store window level/width Yes. Multiple pre-sets
Change default values Yes. Auto window/level; mouse button and wheel for manual
change
Scope of windowing Selectable: single image, series or all images
Grey level inversion Yes
Image zoom and pan Yes. Can be controlled by mouse
Image rotation and flip Yes
15
Table 29: Regions of interest (ROI)

ROI types User information
Circular Yes
Rectangular Yes
Free-hand Yes
Other Ellipse and point
Table 30: Regions of interest (ROI) functions

ROI functions User information
Moving ROI Yes
Copying ROI onto same image No
Copying ROI onto new image No
Replicating ROI on new image No
Maximum number of ROI > 20
Crop inside ROI No
Crop outside ROI No
Table 31: Regions of interest (ROI) analysis

ROI analysis User information
Dimensions and position Yes
Area Yes
Volume No
Statistics Yes
Histograms No
Other No
16
Table 32: Image distance measurements

Distance measurements User information
Scaled grid overlay Yes
Distance and angle values Yes
Moveable measurement points Yes
Table 33: Image profiles

Image profiles User information
Multiple profiles Yes
X and Y values on profile Yes
Distance measurements Yes
Figure 5. User interface
Table 34: Image functions

Image functions User information
Image addition No
Image subtraction No
Image multiplication No
Image division No
Image histograms No
Image averaging Yes, using MPR function
17
Table 35: Image enhancement: SNR

SNR improvement User information
Enhanced display processing No
filters
Table 36: Image enhancement: resolution

Resolution improvement User information
Yes No
Table 37: Image enhancement: uniformity

Uniformity correction User information
Yes No
Table 38: Image enhancement: geometric distortion

Geometric distortion correction User information
Automatic In-plane gradient distortion correction as part of
reconstruction
Table 39: Post processing functions

Distance measurements Console* User information
MPR OC Yes
MIPs Not available
Volume measurements Not available
Surface rendering Not available
Flow analysis Not available
*Console Key: OC - operator console, IC – independent console, O – optional.
18
Radio-frequency (RF) coils

The following three definitions are provided by MagNET to clarify the RF coils’
design and components:
1. # output channels: number of independent RF receiver channels the RF

coil plugs into
2. # elements for QD/CP: number of elements used for quadrature

(QD)/circularly polarised (CP) detection
3. # elements for LP: number of elements used for linearly polarised (LP)
detection.
Manufacturers have been asked to adopt the above definitions in the

description of their coils.
Table 40: Extremity coils

Name Type Dimensions # output # elements # elements S/O†
cm channels for QD/CP for LP
Upper T/R-Q 12.3 1 16 16 S
Extremity (dia)
Lower T/R-Q 18 1 16 16 S
Extremity (dia)
EXTREME T/R-Q 16 1 16 16 O
High SNR (dia)
*R=receive, T/R=transmit/receive, PA=phased array, QD=quadrature, CP= circularly polarised, L=linear,
w=width, h=height, d=depth, l=length, dia=diameter, circ=circumference
†
S = standard, O = optional (may be offered in tailored package)
Figure 6. Image of the right wrist acquired with the 123 mm quadrature coil
19
Sequences and packages

Table 41: Spin echo (SE) sequences
Sequence name Description S/O*
2D/3D SE 2D & 3D spin echo (SE) S
2D/3D TSE 2D & 3D fast spin echo (FSE) S
2D DSE N/A
2D MSE N/A
SS TSE N/A
HASTE N/A
*S=standard, O= included in an optional package (see packages), N/A= not available
Table 42: Inversion recovery (IR) sequences

2D IR 2D SE-inversion recovery, 2D FSE-inversion recovery S
TIR N/A
STIR Short tau inversion recovery S
DarkFluid T2 N/A
HASTE IR N/A
True IR “True” inversion recovery S
Table 43: Gradient echo (GE) sequences

2D/3D GE 2D & 3D gradient echo S
2D/3D FLASH N/A
TurboFLASH N/A
3D FISP N/A
3D PSIF N/A
True FISP N/A
2D/3D TOF N/A
3D DESS N/A
3D CISS N/A
2D TGSE N/A
20
Table 44: Echo planar imaging (EPI) sequences

EPI N/A
Table 45: Acquisition parameters

Parameter Specification
Imaging range Upper extremity (elbow to fingers); lower extremity (knee to
toes including long bones)
Slice planes Transverse, coronal, sagittal and oblique
Head FOV (mm) 40-160
2D slice thickness (mm) 2 to 10
3D slice thickness (mm) 0.5 to 10
2D slice gap (mm) 0.1 to 10
2
2D max slices (256 ) 64
2
3D max slices (256 ) 128
Flip angle (degrees) 25 to 180
Number of echoes 1 for FSE, GE2D and GE3D; 2 for SE
TSE factor 16
Signal averages 16
Max acquisition matrix 512 x 512
Dynamic scans No
Table 46: Parallel imaging

Package Manufacturers name Description
Parallel Not available
acquisition
imaging
Table 47: Packages (optional)

Package Manufacturers name Description
160 mm high SNR coil for extremity imaging
160 mm Coil EXTREME
of smaller knees, larger hands and elbows
Extremity Padded, moveable ottoman to support the leg
“Ergo”
Ottoman or arm during imaging
21
Table 48: Artefact reduction techniques

Generic Package User information
Anti-aliasing Standard operation Factor of 2 in readout direction always on
and not user programmable. No phase
wrap in phase direction. User adjustable
percentage from 0 to 100%
Spectral pre-saturation FatSat Frequency selective RF pulses to
suppress bright signal from fat
Spatial pre-saturation Standard User selectable
RF Spoiling Standard User selectable
Minimum TE Standard User selectable
Flow compensation Standard User selectable
Other No phase wrap User selectable
Partial data User selectable
Magnetization transfer User selectable
Table 49: Imaging options

Generic Manufacturers name User information
Variable bandwidth Standard 5kHz – 100kHz
Other Single & double oblique Requires graphical slice selection
Table 50: Time saving options

Generic Manufacturers name User information
Rectangular FOV FOV ratio User selectable
User selectable in readout or phase,
but not both at the same time. Variable
in readout to reduce TE in SE and GE
K-space reduction Partial data
2D and 3D sequences. User
adjustable in phase direction for scan
time reduction from 55 to 100%.
Echo sharing Not available

Other
Rectangular FOV User selectable

22
Acoustic noise
Table 51 displays 2D and 3D fast imaging pulse sequences chosen as
indicative of the worst cases in clinical imaging. The acoustic noise levels for
these sequences are displayed in Table 52. These levels are provided for
indication only. Variations in factors such as room acoustics may mean that
similar noise levels may not be reproduced at a different site - even with an
identical pulse sequence. Acoustic noise levels are given in terms of the
continuous equivalent level, LAeq, which is A-weighted root-mean-square sound
pressure level (SPL) averaged over the measurement period of 1 minute. The
peak noise Lpeak measured on a linear weighting scale is also recorded. The
relevant safety levels follow.
Patients and volunteers

IEC-60601-2-33: If the scanner can exceed 99 dB(A) then an instruction for the
use of hearing protection must be included in the manufacturer instructions for
use.
MHRA: Hearing protection is recommended for all patients even when

exposure is less than 99 dB(A). Where sites can demonstrate noise levels
significantly below 85 dB(A) then this requirement may be relaxed. Please refer
to Guidelines for Magnetic Resonance Diagnostic Equipment in Clinical Use:
Medical Devices Agency 2002.
Staff
NOISE AT WORK REGULATIONS 1989 (UK): Employers have legal duty to
protect the hearing of their employees. Hearing protection must be available for
workers exposed to 85 dB(A) and must be worn if levels exceed 90 dB(A).
Hearing protection must also be worn if the peak noise level exceeds 140 dB.
Employers are responsible for performing risk assessments for employees
exposed to noise. This would include staff present in the MR scan room during
imaging.
EU DIRECTIVE 2003/10/EC: This directive becomes effective in the UK in

2006. Compared to the regulations above action levels will be reduced by 5
dB(A). Substitution and control of noisy equipment must be prioritised above the
use of hearing protection.
23
Table 51: Fast imaging pulse sequences for ‘worst case’ acoustic noise
System Sequence
Type/TE/TR/Matrix/FOV/Flip Angle/Slice Width/Slices/Time
ON-ORT 2D GE/5.1/572/160x160/160/30°/2/64/1:34
3D GE/3.6/11/160x160/160/30°/1.0/150/4:45
Table 52: Acoustic noise levels for ‘worst case’ pulse sequences
System Acoustic noise dB(A)
LAeq dB(A) Lpeak dB
ON-ORT 80.0 95.0
73.6 94.4
Emergency systems
Table 53: Shutdown buttons
Buttons User information
Electrical shutdown (on equipment) Yes
Electrical shutdown (on site) Yes
Magnet shutdown (on site) Yes
Table 54: Alarm systems

Alarms User information
Helium monitor Yes. Operator message and automatic remote dial-out to
service
Oxygen monitor Not required due to low helium volume
Refrigeration system Yes. Automatic remote dial-out to service
Room temperature monitor Yes in equipment room. Automatic remote dial-out to
service
24
Table 55: Specific absorption rate (SAR)

Does the system calculate the SAR level when a sequence is selected?
Yes
Does the calculation purely rely on the patient weight entered by the operator?
No, the calculation is based on patient weight, coil, anatomy and sequence.
Does the system show the predicted SAR level before the start of a scan?
Yes
Does the system show a message if the sequence exceeds the safety limit?
Yes
Is the limit that set in IEC 601 standard?
Yes
Can the operator ignore the warning and continue the scan?
No, as required by the IEC regulations. First level and second level of control are the same
for extremity according to the IEC regulations.
As well as the software monitor is there a hardware monitor?
Yes, an average forward rf power trip point is set in amplifier based on local SAR limits,
anatomy, weight and coil.
25
List of safety information

General
Oni OrthOne® Operators Guide (chapter 1)
Reference Manual for Magnetic Resonance Safety: F Shellock. Amirsys Inc,

Salt Lake City, 2003.
Magnetic Resonance Procedures Health Effects and Safety: F Shellock

Ed.CRC Press, Boca Raton, 2001.
UPMC MR Safety Web Site at www.radiology.upmc.edu/MRsafety
Institute of Magnetic Resonance Safety, Education and Research Web Site at

www.mrisafety.com.
Medicines and Healthcare products Regulatory Agency

Guidelines for Magnetic Resonance Diagnostic Equipment in Clinical Use:
Medical Devices Agency 2002.
MDA/2003/014 - Static MRI scanners with quench vent pipes.
MDA Safety Warning SN 2001 (27) – Programmable Hydrocephalus Shunts:

Risks of Reprogramming during MRI Procedures
Safety notice MDA SN 9517. Risk of burns to patients, with attached monitoring
leads, undergoing MRI scan: Medical Devices Agency. July 1995.
Medicines and Healthcare products Regulatory Agency Adverse Incident

Reporting at www.medical-devices.gov.uk.
National Radiological Protection Board

NRPB: Advice on limiting exposure to electromagnetic fields (0-300 GHz)
Volume 15 Number 2 2004. www.nrpb.org.
NRPB Board Statement on “Principles for the protection of patients and

volunteers during clinical magnetic resonance diagnostic procedures” Volume 2
Number 1 1991.
ICNIRP: Guidelines for Limiting Exposure to Time-Varying Electric, Magnetic,

and Electromagnetic Fields (up to 300 GHz), Health Physics Vol. 74, No 4, pp
494-522, 1998. www.icnirp.de.
26
Other bodies
IEC 60601-2-33:2002 (Medical Electrical Equipment. Part 2. Particular
Requirements for Safety. Section 2.33 Specifications for Magnetic Resonance
Equipment for Medical Diagnosis). www.iec.ch
FDA Center for Devices and Radiological Health www.fda.gov/cdrh
NHS advice
Health Building Note 6, Supplement 1: Accommodation for Magnetic
Resonance Imaging. Produced by NHS Estates, published by HMSO PO Box
276, London SW8 5DT. ISBN 0113217307.
Health Building Note 6, Volume 3: Extremity and open MRI, magnetic shielding
and construction for radiation protection. Produced by NHS Estates, published
by HMSO PO Box 276, London SW8 5DT. ISBN 0113224869.
Health Guidance Note: Magnetic Resonance Imaging. Produced by NHS

Estates, published by HMSO PO Box 276, London SW8 5DT. ISBN
0113220510.
‘Facilities for diagnostic imaging and interventional radiology’ Produced by NHS

Estates in 2001, published by HMSO PO Box 276, London SW8 5DT. ISBN
0113220000.
27
Introduction to evaluation
The technical performance of the ONI OrthOne® 1 T is provided in this section
of the report. Evaluated whole-body 1 T systems are shown in Table 57.
MagNET requires all images to be acquired without any pre-reconstruction or

post-processing filters. However, this is not possible for some manufacturers
where pre-reconstruction filters are part of the reconstruction process and
cannot be switched off. All OrthOne® images are automatically interpolated to
2562 or 5122 depending on the size of the image acquisition matrix using zero-
filling of k-space.
More information about imaging protocols, image analysis including SNR

normalisation and test objects can be found at the MagNET website
www.magnet-mri.org
Table 56: MR model abbreviation key for extremity 1 T systems

Manufacturer Model Gradient Code Assessment
Date
ONI OrthOne® Not named ON-ORT 23/07/04
Table 57: MR model abbreviation key for whole body 1 T systems

Manufacturer Model Gradient Code Assessment
Date
GE SIGNA MR/i HighSpeed GE-SIG 26/02/00
PHILIPS GYROSCAN INTERA Power PH-INT 31/01/00
MARCONI POLARIS PowerDrive 150 MA-POL 01/08/98
SIEMENS MAGNETOM HARMONY Ultra SI-HAR 25/02/97
28
Gradient labelling convention

The ONI OrthOne® 1 T is a horizontal field MR scanner and it is necessary to
explain x-, y- and z-directions used in the report. The z-direction is always the
direction of the static magnetic field B0, as shown in Figure 7.
Figure 7: Gradient labelling with respect to magnet
z
29
180 mm coil evaluation

180 mm coil: signal to noise ratio (SNR)
Scan parameters
Table 58: 180 mm coil: signal to noise ratio (SNR) measurement

parameters.
Standard protocol Actual protocol
Test object MAGFF_LOADED MAGBOT
Loading Internal in test-object None
Sequence SE SE
TE (ms) 30 30
TR (ms) 1000 1000
NSA 1 1
FOV (mm) 250 160
Matrix (PE x FE) 256 x 256 160 x 160
(Interpolated to 256 x 256)
Bandwidth (kHz) Manufacturer’s choice ± 25.0
Temperature (°C) 24
Slice width (mm) 5 5
Scan time (min:sec) 4:16 2:43
Image plane TRA, SAG, COR TRA, SAG, COR
Interpretation of results
The image SNR value obtained on a system is influenced by many factors. For
example, system factors such as the main magnetic field strength Bo and the
design of the radiofrequency receive and transmit systems can affect the SNR.
Other factors are the choice of sequence and imaging parameters.
The comparison made in Graph 1 shows the image SNR normalised for voxel
size, scan time, coil quality factor, and sampling bandwidth for 1 T systems.
There was no correction for coil quality factor for the ONI OrthOne®.
The image SNR and normalised SNR results are presented in Table 59.
Comment on results
The SNR values for this coil were slightly above average for a 1 T system.
30
Table 59: Signal to noise ratio for the 180 mm coil

Transverse Sagittal Coronal Mean
Image SNR 73 71 71 72
Normalised SNR 1002 1088 1043 1044
Graph 1: Comparison of normalised SNR (mean of three planes)
ON-ORT
System
MEAN-1T-WB†
0 200 400 600 800 1000 1200

Normalised SNR (NSNR)
†
Results from head coils
31
180 mm coil: uniformity
Scan parameters
Table 60: 180 mm coil; uniformity measurement parameters.

Test object MAGFF_LOADED MAGBOT
Loading None None
Sequence SE SE
TE (ms) 30 30
TR (ms) 1000 1000
NSA 1 1
FOV (mm) 250 250
Matrix (PE x FE) 256 x 256 160 x 160
The fractional uniformity was calculated over a distance of 140 mm, with the
midpoint positioned at the centre of the test object. The optimum value is 1,
indicating 100% of the signal is considered uniform over the measured distance.
The MagNET protocol specifies that the fractional uniformity should be
calculated as the fraction of the profile lying within ± 10% of its mean value.
The fractional uniformity measurements in the two directions for each plane are
presented in Table 61. The comparison made in Graph 2 shows the mean
fractional uniformity for 1 T systems. Fractional uniformity for whole body
systems is calculated over a slightly larger distance of 160 mm.
Uniformity contour plots are also shown in Figure 8. Red indicates areas of
high signal, with green, blue and white indicating areas of progressively lower
signal. For the 180 mm coil, the level of the high signal (red) is chosen to be 90-
100% of the maximum signal.
Graph 3 shows the uniformity profiles in the x-, y-, and z- directions.
Comment on results
The overall uniformity performance of this coil was above average for a 1 T
system.
32
Table 61: Fractional uniformity for the 180 mm coil

Transverse Sagittal Coronal Mean Mean± SD
X-direction 1.00 - 1.00 1.00
Y-direction 1.00 1.00 - 1.00 1.00 ± 0.00
Z-direction - 1.00 1.00 1.00
Graph 2: Comparison of fractional uniformity (mean of three planes)*
ON-ORT
System
MEAN-1T-WB†
0.5 0.6 0.7 0.8 0.9 1

Fractional Uniformity
*The optimum value is 1.0

†
Graph 3: Uniformity profiles in x-, y-, and z- directions

800
700
600
500 X-direction
Grey Level
Y-direction
400
Z-direction
300
200
100
0
0 32 64 96 128 160 192 224
Pixel Number
33
Figure 8: Uniformity contour maps of 180 mm coil
a) Transverse b) Sagittal c) Coronal
90-100% maximum signal 70-80% maximum signal
80-90% maximum signal < 70% maximum signal

34
180 mm coil: spatial resolution
Scan parameters
Table 62: 180 mm coil: spatial resolution measurement parameters.

Test object TO4 MAG_CB_MTF
MAG_CB_BARS
Loading None None
Sequence SE SE
TE (ms) 30 30
TR (ms) 1000 1000
NSA 1 1
FOV (mm) 250 125
Matrix (PE x FE) 256 x 256 256 x 256
The MAG_CB_MTF test object was used to measure resolution from a MTF
block. The MTF was measured for a 256 x 256 image acquisition matrix in the
PE and FE directions for all three imaging planes.
The resulting resolution measurements are presented, and summarised in

Table 63 and Table 64. The measured resolution should be equal to the
nominal pixel dimension.
The MAG_CB_BARS test object contains a set of 0.5 mm resolution bars. This
phantom was imaged using the same protocol as MAG_CB_MTF.
Figure 9 shows intensity profiles across the 0.5 mm bars in the frequency and
phase encode directions for the transverse plane.
Comment on results
From the MTF measurements the resolution performance in both the FE and
PE direction was within experimental error.
35
Table 63: Pixel dimension measurements (mm) for 2562 matrix (nominal
pixel size 0.49 mm)*
Transverse Sagittal Coronal Mean ± SD
PE 0.52 ± 0.01 0.52 ± 0.01 0.52 ± 0.01 0.52 ± 0.01
FE 0.51 ± 0.01 0.52 ± 0.01 0.51 ± 0.01 0.51 ± 0.01
*The optimum value is 0.50 ± 0.05 mm
Table 64: Mean pixel dimension measurements (mm)*

Matrix Nominal Mean ± SD
256 x 256 0.49 0.52 ± 0.01
*The optimum value is 0.50 ± 0.05 mm
Figure 9: Profiles across 1 mm resolution bars for the transverse plane in

the phase and frequency encode directions for 180 mm coil
a) Frequency encode direction b) Phase encode direction

36
180 mm coil: geometric linearity and distortion
Scan parameters
Table 65: 180 mm coil; geometric measurement parameters.

Test object MAG_GEOM MAG_CB_GM
Loading None None
Sequence SE SE
TE (ms) 30 30
TR (ms) 1000 1000
NSA 1 1
FOV (mm) 256 160
Matrix (PE x FE) 256 x 256 160 x 160
Coefficient of variation
The Coefficient of Variation (CV) is defined as:
standard deviation
CV = x 100%
mean
The geometric linearity results are obtained from a set of horizontal and vertical
distance measurements in the acquired images. The closer these values are to
the actual separation distance of 40 mm, the better the performance. and Table
67 show the values obtained for imaging planes and gradients, respectively.
The coefficient of variation indicates the degree of variation of the distance
measurements from one another. The lower the coefficient, the lower the in-
plane distortion, and the better the performance. As whole body 1 T systems
are evaluated using a separation distance of 120 mm no comparative data are
presented.
Comment on results
The geometric linearity performance measured on this system was within
experimental error.
37
Table 66: Linearity* and distortion† measurements for three planes

Transverse Sagittal Coronal Mean ± SD
Mean (mm) 40.3 ± 0.3 39.8 ± 0.3 40.3 ± 0.3 40.1 ± 0.40
CV (%) 0.85 0.80 0.84 0.83
*Optimal value 40 ± 0.6 mm
†
Optimal value 0
Table 67: Linearity* and distortion† measurements for three gradients

X-direction Y-direction Z-direction Mean ± SD
Mean mm) 40.5 ± 0.3 39.9 ± 0.3 40.0 ± 0.3 40.1 ± 0.40
CV (%) 0.63 0.64 0.99 0.75
*Optimal value 40 ± 0.6 mm
†
Optimal value 0
38
180 mm coil: slice profile and slice width
Scan parameters
Table 68: 180 mm coil; slice profile and slice width measurement
parameters.
Test object MAG_GEOM MAG_CB_SW
Loading None None
Sequence SE SE
TE (ms) 30 30
TR (ms) 1000 1000
NSA 1 1
FOV (mm) 256 160
Matrix (PE x FE) 256 x 256 160 x 160
Slice width (mm) 3, 5 3, 5
The slice profiles should have minimum side lobes, no ringing, and no central
drop-out. Graph 4 shows the measured profiles in the transverse plane. The
measured slice widths for the three imaging planes presented in Table 69
should lie within 10% of the nominal slice width. Graph 5 and Graph 6 show
comparisons of the mean 3 mm and 5 mm slice width measurements for 1 T
systems.
Comment on results
The values obtained in all three planes for both 3 mm and 5 mm slice widths
were within 10% of the nominal slice widths.
Graph 4: 3 mm and 5 mm slice profiles in the transverse plane

750 3 mm
700 5 mm
650
600
550
500
450
Grey Level
400
350
300
250
200
150
100
50
0
0 10 20 30 40 50 60 70 80
Pixel Number
39
Table 69: Slice widths (mm) measured as FWHM of derived profiles

3 mm nominal 2.7 2.7 2.8 2.7
5 mm nominal 5.5 5.0 5.2 5.2
Graph 5: Comparison of measured slice widths (mean of three planes)*
ON-ORT
System
MEAN-1T-WB†
-0.6 -0.4 -0.2 0 0.2 0.4 0.6

Error in measured slice width (mm)
*The optimum value is 0 ± 0.3 mm

†
MEAN-1T-WB†
System
ON-ORT
-0.6 -0.4 -0.2 0 0.2 0.4 0.6


†
40
180 mm coil: ghosting
Scan parameters
Table 70: 180 mm coil; ghosting measurement parameters.

Test object MAG_GHO MAG_GHO
Loading None None
Sequence SE SE
TE1 (ms) 30 30 sequence 1
TR (ms) 1000 1000
NSA 1 2
FOV (mm) 256 160
Matrix (PE x FE) 256 x 256 160 x 160
Slice width (mm) 5 2.5
Scan time (min:sec) 4:16, 8:32 2:43, 5:23
Image plane TRA TRA
The OrthOne® system offers a spin echo sequence with up to two echoes.
Therefore two scans (sequence 1 and sequence 2) were performed for both 1
and 2 NSA to obtain images with all four echo-times listed above.
Table 71 presents the ghosting results for each echo. Ghosting is calculated by
the ratio of the maximum image ghost minus the background noise to the image
signal.
Graph 7 and Graph 8 present results for this system for 1 and 2 NSA
respectively.
Comment on results
For both 1 and 2 NSA the ghosting performance for the 1st echo of each
sequence (30 ms and 90 ms) was significantly better than the ghosting
performance for the 2nd echo of each sequence (60 ms and 120 ms). For both
1 and 2 NSA the ghosting performance for the 1st echo of each sequence was
well above average for a 1 T system whilst the ghosting performance for the 2nd
echo of each sequence was worse than average. See the manufacturer’s
comments on p58 for an explanation.
41
Table 71: Maximum ghosting ratio for 1 and 2 signal averages

NSA Echo Maximum ghosting NSA Echo Maximum ghosting
1 1 0.29 2 1 0.20
1 2 2.28 2 2 2.58
1 3 0.51 2 3 0.10
1 4 2.81 2 4 2.87
Mean 1.47 ± 1.26 Mean 1.44 ± 1.49
Graph 7: Comparison of maximum ghosting (NSA=1)*
MEAN-1T-WB†
1st echo
System
2nd echo
3rd echo
4th echo
ON-ORT
0 0.5 1 1.5 2 2.5 3

Maximum ghost to noise ratio
*Optimal value = 0
†
MEAN-1T-WB†
1st echo
System
2nd echo
3rd echo
4th echo
ON-ORT
0 0.5 1 1.5 2 2.5 3

*Optimal value = 0
†
42
123 mm coil evaluation

123 mm coil: signal to noise ratio (SNR)
Scan parameters
Table 72: 123 mm coil; signal to noise ratio (SNR) measurement

parameters.
Test object MAGFF_LOADED MAG_WRIST
Loading Internal in test-object None
Sequence SE SE
TE (ms) 30 30
TR (ms) 1000 1000
NSA 1 1
FOV (mm) 250 160
Matrix (PE x FE) 256 x 256 160 x 160
Temperature (°C) 24
The image SNR value obtained on a system is influenced by many factors. For
example, system factors such as the main magnetic field strength Bo and the
design of the radiofrequency receive and transmit systems can affect the SNR.
Other factors are the choice of sequence and imaging parameters.
The image SNR and normalised SNR results are presented in Table 73. SNR
is normalised for voxel size, scan time, and sampling bandwidth. No correction
was made for coil quality factor.
Comment on results
The SNR values for this coil were high. Due to the small size of this coil no
comparison is made with whole body 1 T systems.
43
Table 74: Signal to noise ratio for the 123 mm coil

Image SNR 366 331 301 333
Normalised SNR 5620 5084 4625 5109
44
123 mm coil: uniformity
Scan parameters
Table 75: 123 mm coil; uniformity measurement parameters.

Test object MAGFF_OIL MAG_WRIST
Loading None None
Sequence SE SE
TE (ms) 30 30
TR (ms) 1000 1000
NSA 1 1
FOV (mm) 250 160
Matrix (PE x FE) 256 x 256 160 x 160
(Interpolated to 256 x
256)
Uniformity profiles in the x-, y-, and z- directions are provided in Graph 9.
Uniformity contour plots are also shown in Figure 8. Red indicates areas of
high signal, with green, blue and white indicating areas of progressively lower
signal. For the 123 mm coil, the level of the high signal (red) is chosen to be 90-
100% of the maximum signal.
Comment on results
The uniformity values for this coil were high. Due to the small size of this coil no
comparison is made with whole body 1 T systems.
45
Graph 9: Uniformity profiles in x-, y-, and z- directions

6000 X-direction
Y-direction
5500
Z-direction
5000
4500
4000
Grey Level
3500
3000
2500
2000
1500
1000
500
0
0 32 64 96 128 160 192 224
Pixel Number
Figure 10: Uniformity contour maps of 123 mm coil
a) Transverse b) Sagittal c) Coronal
90-100% maximum signal 70-80% maximum signal
80-90% maximum signal < 70% maximum signal

46
123 mm coil: slice profile and slice width
Scan parameters
Table 76: 123 mm coil; slice profile and slice width measurement
parameters.
Test object MAG_GEOM MAG_CB_SW
Loading None None
Sequence SE SE
TE (ms) 30 30
TR (ms) 1000 1000
NSA 1 1
FOV (mm) 256 100
Matrix (PE x FE) 256 x 256 160 x 160
Slice width (mm) 3, 5 3, 5
The slice profiles should have minimum side lobes, no ringing, and no central
drop-out. Graph 10 shows the measured profiles in the transverse plane. The
measured slice widths for the three imaging planes presented in Table 77
should lie within 10% of the nominal slice width. Graph 11 and Graph 12 show
comparisons of the mean 3 mm and 5 mm slice width measurements for 1 T
systems.
Comment on results
The values obtained in the transverse plane for both 3 mm and 5 mm slice
widths were within 10% of the nominal slice widths.
Graph 10: 3 mm and 5 mm slice profiles in the transverse plane

750 3 mm
700 5 mm
650
600
550
500
450
Grey Level
400
350
300
250
200
150
100
50
0
0 10 20 30 40 50 60 70 80
Pixel Number
47
Table 77: Slice widths (mm) measured as FWHM of derived profiles

Transverse
3 mm nominal 2.7
5 mm nominal 4.7
MEAN-1T-WB†
System
ON-ORT‡
-0.6 -0.4 -0.2 0 0.2 0.4 0.6


†
‡
Results from transverse plane only
MEAN-1T-WB†
System
ON-ORT‡
-0.6 -0.4 -0.2 0 0.2 0.4 0.6


†
‡
Results from transverse plane only
48
123 mm coil: ghosting
Scan parameters
Table 78: 123 mm coil; ghosting measurement parameters.

Test object MAG_GHO MAG_GHO
Loading None None
Sequence SE SE
TR (ms) 1000 1000
NSA 1 2
FOV (mm) 256 100
Matrix (PE x FE) 256 x 256 200 x 200
(Interpolated to 256 x
256)
Slice width (mm) 5 2.5
Scan time (min:sec) 4:16, 8:32 3:23, 6:43
Image plane TRA TRA
The OrthOne® system offers a spin echo sequence with up to two echos.
Therefore two acquisitions (sequence 1 and sequence 2) were performed for
both 1 and 2 NSA to obtain images with all four echo-times listed above.
Table 78 presents the ghosting results for each echo. Ghosting is calculated by
the ratio of the maximum image ghost minus the background noise to the image
signal. Graph 13 and Graph 14 present results for this system for 1 and 2 NSA
respectively.
Comment on results
For both 1 and 2 NSA the ghosting performance for the 1st echo of each
sequence (30 ms and 90 ms) was significantly better than the 2nd echo of each
sequence (60ms and 120 ms). For 2 NSA the ghosting performance for the 1st
echo of each sequence was well above average for a 1 T system whilst the
ghosting performance for the 2nd echo of each sequence was worse than the
average. See the manufacturer’s comments on p58 for an explanation.
49
Table 79: Maximum ghosting ratio for 1 and 2 signal averages

NSA Echo Maximum ghosting NSA Echo Maximum ghosting
1 1 0.24 2 1 0.57
1 2 2.18 2 2 2.26
1 3 1.66 2 3 0.61
1 4 2.30 2 4 2.17
Mean 1.60 ± 0.95 Mean 1.40 ± 0.94
MEAN-1T-WB†
1st echo
System
2nd echo
3rd echo
4th echo
ON-ORT
0 0.5 1 1.5 2 2.5

*Optimal value = 0
†
MEAN-1T-WB†
1st echo
System
2nd echo
3rd echo
4th echo
ON-ORT
0 0.5 1 1.5 2 2.5 3

*Optimal value = 0
†
50
Functionality evaluation
Functionality: multiple slice measurements
I- Multiple slice acquisition
Scan parameters
Table 80: Multiple slice measurement parameters*.

Guideline protocol Actual protocol
Coil(s) evaluated Head 180 mm
Test object TO1 & TO4A MAGCBPB, MAGCBFF
Loading None None
Sequence SE SE
TE (ms) Manufacturer’s choice 22
TR (ms) Manufacturer’s choice 2336
NSA Manufacturer’s choice 1
FOV (mm) 250 160
Image plane TRA TRA
Matrix (PE x FE) I Maximum 512 x 512
Slice width (mm) II Minimise 2
Contiguous slices III Maximise 62
Scan time (min:sec) IV Minimise 19:58
*Roman numerals I to IV indicate the order in which the scan parameters are prioritised
II- Maximum 2D slices

Acquire the (quoted) maximum number of 2D slices using the above protocol,
but with the scan parameter priorities re-ordered to III, I, II, IV.
The multiple slice acquisition protocol is chosen with the objective of maximising
the coverage with good resolution. Table 81 presents a comparison of multiple
slice protocols on systems of equivalent field strength.
Table 81 presents the protocols used for acquiring a maximum number of 2D

slices.
51
Table 81: Results 1 - multiple slice acquisition protocols for 1 T systems*

System Matrix Slice No. of Scan time Sequence TE/TR/NSA
width slices TE & TR (ms)
(mm) (mins)
PH-INT 1024 x 1024 0.5 24 19:00 31/555/1
SI-HAR 1024 x 1024 1.0 31 19:40 20/1166/1
MA-POL 512 x 512 0.9 78 20:00 14/2344/1
ON-ORT 512 x 512 2.0 62 19:58 22/2336/1

*Ordered on (I) matrix, (II) slice width, (III) number of slices, & (IV) scan time
Table 82: Results 2 - maximum 2D slices for 1 T systems

System No. of Matrix Slice Scan time Sequence TE/TR/NSA
slices width TE & TR (ms)
(mm) (mins)
PH-INT 256 96 x 96 0.5 18:11 31/5629/1
MA-POL 157 256 x 256 0.9 20.00 14/4680/1
SI-HAR 87 256 x 256 0.5 21:25 32/4995/1
ON-ORT 62 512 x 512 2.0 19:58 22/2336/1
*Ordered on (III) number of slices, (I) matrix, (II)slice width, & (IV) scan time
52
180 mm coil: clinical fast sequences

Table 83: Clinical fast sequences measurement parameters.
Coil Head coil 180 mm coil
Test object MAGFF_OIL MAGCBPB, MAGCBFF
Loading None None
Image plane TRA TRA
2D Sequence Manufacturer’s choice 2D GE

TE (ms) / TR (ms) Manufacturer’s choice 5.1 / 572
Flip angle / NSA Manufacturer’s choice 90° / 1
FOV (mm) 250 160
Matrix (PE x FE) 256 x 256 160 x 160
Range (mm) I To equal 200 128
Contiguous slices II Maximum 64
Scan time (min:sec) III Minimise 1:34
3D Sequence Manufacturer’s choice 3D GE

TE (ms)/TR (ms) Manufacturer’s choice 3.6 / 11
Flip angle / NSA Manufacturer’s choice 30° / 1
FOV (mm) 250 160
Matrix (PE x FE) 128 x 128 160 x 160
Range* (mm) I To equal 200 150
Contiguous slices* II Maximum 150
Scan time* (min:sec) III Minimise 4:45
* I to III indicate the order in which the scan parameters are prioritised.
A fixed volume is acquired using clinical 2D and 3D fast imaging sequences.
The aim is to measure data acquisition speed in voxels/second. The voxel size
is defined by the matrix and the number of slices in the fixed range. Imaging
speed is calculated using the time required to acquire the images. Table 84
gives the 2D and 3D imaging speeds measured on this system.
53
Graph 15 and Graph 16 show a comparison of 2D and 3D imaging speed for

1 T systems evaluated. Details of the 2D and 3D sequences used for each of
these systems are given in the Appendix.
Comment on results
The 2D and 3D imaging speed was below the average of 1 T systems
Table 84: Imaging speed using parallel imaging

Imaging speed
voxels per second
2D 3D
17902 14545
Graph 15: Comparison of 2D imaging speed
MEAN-1T-WB
System
ON-ORT
0 10000 20000 30000 40000 50000

2D Imaging speed (voxels/sec)
Graph 16: Comparison of 3D imaging speed
MEAN-1T-WB
System
ON-ORT
0 10000 20000 30000 40000 50000

2D Imaging speed (voxels/sec)
54
Conclusion
Technical summary tables

Table 85: Comparison of performance of the Oni OrthOne® 1 T system
with mean of whole body 1 T systems evaluated by MagNET*
Parameter Optimum Mean ± SD No. of ON-ORT
value systems
180 mm coil
SNR (normalised) Maximum 1029 ± 242 4 1044
Uniformity 1.00 0.93 ± 0.04 4 1.00
PE pixel size (mm) 0.50 - 1 0.52
FE pixel size (mm) 0.50 - 1 0.51
Linearity (mm) 40 - 1 40.1
Distortion 0.00 - 1 1.1
3 mm slice width 3.0 3.2 ± 0.3 4 2.7
5 mm slice width 5.0 5.2 ± 0.5 4 5.3
Ghosting (NSA =1) 0 0.68 ± 0.82 4 1.47†
Ghosting (NSA =2) 0 0.65 ± 0.82 4 1.44†
123 mm coil
SNR (normalised) Maximum - 5109
Uniformity 1.00 - - 1.00
3 mm slice width 3.0 3.2 ± 0.3 4 2.7‡
5 mm slice width 5.0 5.2 ± 0.5 4 4.7‡
Ghosting (NSA =1) 0 0.68 ± 0.82 4 1.60†
Ghosting (NSA =2) 0 0.65 ± 0.82 4 1.40†
Functionality
2D imaging speed Maximum 44482 ± 8866 3 17902
3D imaging speed Maximum 25671 ± 10753 3 14545
* Results from whole body 1 T systems using head coils are provided for indicative purposes not for direct
comparison
†
See manufacturer’s comments
‡
Transverse plane only
55
Conclusion
Overall comments on technical performance

Table 86: Overall comments on technical performance*
Evaluation Parameter Comment
180 mm coil evaluation SNR (normalised) Above average
Uniformity Above average
PE pixel dimension Within experimental error†
FE pixel dimension Within experimental error†
Linearity Within experimental error‡
Distortion No comment
3 mm slice width Within experimental error¶
Ghosting Well above average performance for

1st echo of dual echo sequence.
Worse than average performance for
second echo of dual echo sequence§
123 mm coil evaluation SNR (normalised) Very high
Uniformity High
Ghosting Well above average performance for

1st echo of dual echo sequence (for 2
NSA). Worse than average
performance for second echo of dual
echo sequence§
Functionality evaluation 2D imaging speed Below average
3D imaging speed Below average

* Average defined by mean of all whole body 1 T systems using head coils
†
Defined as an error of ±10% in the nominal pixel size.
‡Defined as an error of ± 0.6 mm in a measurement of 40 mm.
¶
Defined as an error of ±10% in the nominal slice width.
§
Two dual echo sequences were used instead of a single four echo sequence. See manufacturer’s
comments for explanation of result
56
Acknowledgements
MagNET would like to acknowledge the support of Oni, Xograph and Medirad
Scandinavia AS during this evaluation.
57
Appendix
Manufacturer’s comments
The high ghosting in the second echo of the double echo conventional spin
echo sequence is a result of residual signal remaining from the 3 RF pulses for
certain sequence parameters and is not related to any underlying system
instability or imperfection. This will be corrected in a future software pulse
sequence release.
58
Appendix
Manufacturer’s QA method
The daily QA test consists of a scan using the 180 mm RF transmit coil and
Daily QA phantom provided with the system. The QA procedure is a built in
sequence with preset scan parameters. Analysis of the image is performed by
automatic generation of regions of interest. The SNR, noise and artifacts
(ghosting) is computed. The primary pass fail for the system is SNR.
The resultant image, regions of interest and computed SNR and noise are
presented to the operator and written to the system log file for review later by
the operator or service personnel.
59
Appendix
Background information
MagNET
The assessment reported on the preceding pages was carried out by the
Magnetic resonance National Evaluation Team (MagNET) based at Imperial
College London. The project is supported by the Department of Health to
assess the imaging performance of commercially available clinical MR systems.
Resources from the National Health Service fund the project.
Medicines and Healthcare products Regulatory Agency (MHRA)

One of the roles of the MHRA, an executive agency of the Department of
Health, is to manage evaluation programmes for medical devices and
equipment. MHRA’s Device Evaluation Service (DES) business unit is
responsible for this work. The evaluation of magnetic resonance imaging
equipment is part of the diagnostic imaging evaluation programme also covering
computed tomography and both general and digital x-ray equipment, including
mammography.
MHRA is also the Competent Authority for medical devices in the UK, with
responsibilities for negotiating European Directives and implementing and
enforcing UK Regulations for medical devices. MHRA’s European and
Regulatory Affairs section is responsible for this work and regularly issues
guidance on the Regulations. MHRA’s Device Technology and Safety Group is
responsible for investigating adverse incidents associated with medical devices
and their use, and helping to prevent further incidents by communicating
findings to those who make or use the devices. Further details about MHRA and
its activities can be found by visiting the MHRA website (www.mhra.gov.uk)
Manufacturer involvement
The choice of MR system to be evaluated is influenced by both new system
releases and customer demand. Both the user and clinical evaluations are
performed with the active participation of the manufacturer. The clinical sites are
chosen by MagNET from a short-list provided by the manufacturer. The
technical evaluation is carried out at a site agreed with the manufacturer, where
the performance of the system is within specification and is representative of
that model. Acknowledgement is made to the company for arranging and
supporting the examination of MR equipment. A copy of each report is sent to
the manufacturer of the equipment for comment before publication. These
comments are included in the published report.
60
Appendix
Availability of other reports

Information on previous and future MR evaluation reports is given on the
MagNET website. This evaluation report is one of a series issued regularly by
the Department of Health. For information on reports from other modalities
contact the MHRA.
Contact details
MagNET
In addition to answering queries on the evaluation reports, MagNET can provide
advice on detailed specification, general MR technology, acceptance testing
and quality assurance.
MagNET
Department of Bioengineering
Bagrit Centre
Imperial College London
London SW7 2AZ
! Tel: 020 7594 6306

Fax: 020 7594 6337
# E-mail: enquiry@magnet-mri.org
Web page: http://www.magnet-mri.org/
MHRA general enquiries

Device Evaluation Service
Medicines and Healthcare products Regulatory Agency
Hannibal House
Elephant and Castle
London SE1 6TQ.
! Tel: 020 7972 8155

Fax: 020 7972 8105
# E-mail: des@mhra.gsi.gov.uk
Web page: http://www.mhra.gov.uk/
61
Appendix
Clinical fast sequences used for evaluation

For a description of sequences see www.magnet-mri.org
Table 87: 2D clinical fast sequences (1 T systems)*†

System Voxels No. of Scan Matrix Slice Sequence
(sec-1) slices time width SEQ/TE/TR/NSA/FA/
(mins) (mm) TE & TR (ms)
PH-INT 54065 40 0:49 256 x 256 5.0 FE/2.5/189.4/1/30
SI-HAR 42809 128 3:16 256 x 256 4.0 TrueFISP/3/5.98/1/70
MA-POL 36571 50 1:29 256 x 256 4.0 FAST/2.6/7/1/80
ON-ORT 17902 64 1:34 160 x 160 2.0 2D GE/5.1/570/1/30
* Ordered on (I) voxels per second & (II) number of slices
†
For description of sequences see www.magnet-mri.org
Table 88: 3D clinical fast sequences (1 T systems)*†

System Voxels No. of Scan Matrix Slice Sequence
(sec-1) slices time width SEQ/TE/TR/NSA/FA
(mins) (PE x FE) (mm) TE & TR (ms)
PH-INT 35556 128 1:32 128 x 128 1.6 3D FFE /1.78/3.6/1/30
SI-HAR 27234 64 0:38 128 x 128 2.5 FLASH 3D/1.9/4.7/1/15
ON-ORT 14545 150 4:45 160 x 160 1.0 3D GE/3.6/11/1/30
PI-P10-98 14222 67 1:30 128 x 128 3.0 3D FFE/3.36/9/1/20
*Ordered on (I) voxels per second & (II) number of slices
†
For description of sequences see www.magnet-mri.org
62
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ONI Medical Systems. OrthOne® 1 T MR imaging system

Technical Report · April 2005

Janet De Wilde Ioannis Delakis

SEE PROFILE SEE PROFILE

The user has requested enhancement of the downloaded file.

best choice • best practice www.mhra.gov.uk nww.medical-devices.nhs.uk

How to obtain MHRA reports

Tel: 020 7972 8181

Visit www.mhra.gov.uk for a comprehensive list of publications, details of

Janet De Wilde, David Price,

Director: Richard I. Kitney OBE

T: 020 7594 6305

© Crown Copyright 2005

The MHRA is an executive agency of the Department of Health

ISBN 1- 84182 950 1

More information including details of evaluation protocols, test objects

This report provides a detailed evaluation of ONI Medical Systems

The following paragraphs comment on the overall technical performance of this

Measured parameters with outstanding performance levels for a 1 T system

• 180 mm coil SNR

Measured parameters with performance levels as expected for a 1 T system

• 180 mm coil resolution performance

Measured parameters with performance levels below average for a 1 T system

Scope, structure and MHRA

The technical assessment aims to obtain type-test measurements of imaging

Additional information is obtainable from the website www.magnet-mri.org

Conformity with standards and EC directives

Table 2: Equipment conformity with international standards

ONI OrthOne® ON-ORT

The ONI OrthOne® 1 T, shown in Figure 1, is a dedicated extremity scanner

Figure 1. ONI OrthOne® scanner

The system features a separate adjustable patient couch to allow the

The RF system features a single independent RF receiver channel with variable

The RF hardware consists of removable quadrature volume transmit- receive

A standard set of imaging sequences is provided for extremity imaging. This

Table 5: Magnet specification

Magnet and gradient system

Table 7: Shimming details

Table 8: Patient comfort details

Table 9: Installation details

Table 10: Electronics cabinets

Table 11: RF system specification

Table 12: Gradient system specification

Table 14: Main computer system – image processor

Table 15: Image display monitor

Bit depth bit Not known

Table 16: Networking

Table 17: Independent console

Table 18: Resolution parameters

Table 19: Speed parameters

Table 21: Gantry control panel

Figure 3. Patient positioning for knee imaging and wrist imaging

Table 22: Cable connectors

Table 23: Patient couch specification

Table 24: Accessories

Figure 4: View of ONI OrthOne® keyboard & 19” LCD*

Table 26: Operator console – features

Table 27: Operator console – multi-tasking

Table 28: Image display

Table 29: Regions of interest (ROI)

Table 30: Regions of interest (ROI) functions

Table 31: Regions of interest (ROI) analysis

Table 32: Image distance measurements