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Computed Tomography Laser Mammography - Catalogue 2 |
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Positioning
accuracy - orbit position
is accurate to better than ¡¾0.1%, relative to the start
flag.
Rotational speed constancy - orbit speed variations do
not exceed ¡¾3% over the orbit time range of 12 - 45 seconds.
Elevation
accuracy - elevator position accuracy is better
than ¡¾0.5mm.
Laser Stability
- for the duration of 1 slice (45 seconds max),
the laser output power varies no more than ¡¾0.2% peak-to-peak.
Perimeter Accuracy
- the measured perimeter lies within ¡¾0.5 millimeters
of a fitted circle, measured with a centered 110mm diameter,
circular IntraLipid-filled phantom. |
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ELECTRICAL |
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Earthing - All devices that receive hazardous
voltage with accessible metal parts have less than 0.1
Ohms of resistance between the accessible metal part
and the earth ground at the supply connection.
Residual Power
- a voltage of 60V is not available at the source of
the unit 1 sec after the disconnection from the mains.
Isolation
- The surfaces of the unit that are intended to come
in contact with the patient are isolated from the power
circuits such that a potential of 1500Vdc is applied
between the two points and a breakdown of the insulation
does not occur.
Leakage Current
- The maximum normal condition leakage current does
not exceed 500 microamperes. The maximum single fault
leakage current does not exceed 1 mA.
Operator Console
- The Operator Console requires a 220VAC line source
(198VAC - 250VAC) at 50/60 Hz with a capacity of 20
Amps.
System
- The system typically draws 5 Amps at 220VAC, 60 Hz.
The heat dissipation is 1100 Watts or 3760 BTUs/hour. |
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¤ýSCANNER
BED AND GANTRY |
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The scanning bed provides a horizontal surface for the
patient to lie prone during the scan. It is 737mm (29¡±)
tall for easy patient access and includes a cushioned
pad for patient comfort.
The scanning bed includes 4 breast-centering rings,chosen
appropriate to the patient¡¯s breast size. The enclosure
of the Scanner is of fiberglass material supported by
a
metal frame.
The power electronics are housed in a steel box in the
middle of the Scanning Bed. The Scanning Bed is 88¡± x
34¡± (2235mm x 865mm) and weighs 465 lbs (210 kg). |
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OPERATOR CONSOLE |
Weight
Rating - The scanner is rated for a uniformly
distributed load of 2500 lbs (1140 kg). Maximum patient
weight is 400 lbs (180 kg).
OPERATOR CONSOLE |
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Operator Console includes the system PC, a 21¡± LCD video
monitor for image review, a writable DVD-R drive for image
archive and an optical mouse and keyboard for operator
interaction. The system PC is a Pentium 4 personal computer,
running the Windows XP operating System and
CTLM system software. It includes 1GB of memory, dual |
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120GB mirrored disk drives for data storage and a 256MB
video card. The operator¡¯s console includes an uninterruptible
power supply for immunity to power surges and dropouts
and has drawer space for storage.
An optional image printer can connect to the operator¡¯s
console or Physician¡¯s Review Station. The Operator¡¯s
Console is 53¡± x 33¡± (1345mm x 840mm),weighs 390 lbs
(180 kg) and is made of fiberglass.
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Environmental
-The CTLM operates in a temperature range of +18¡ÆC to
+27¡ÆC, a relative humidity of 30% to 75% and an atmospheric
pressure of 700hPa to 1060hPa (altitudes of sea level
to 10,000 feet), so long as the dew point does not exceed
the laser operating temperature of 19¡ÆC.
Shock and Vibration - The
CTLM, in its original shipping materials, meets the
vibration requirements of MIL-810F, per Annex A, section
2.2.1, Category 4a - Truck transportation over US highways.
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PHYSICIAN REVIEW STATION
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The CTLM Physician Review
Station (PRS) is an accessory to the CTLM to allow simultaneous
image review and filming while scanning. The PRS supports
the full display functionality of the CTLM system. It
can be used to film images, reformat images into axial,
sagittal, and 3D projections. The PRS can perform any
image metrics supported by the CTLM display software for
the current scan in progress.
The PRS consists of a PC, a 21¡± LCD video monitor for
image review and an uninterruptible power supply for
immunity to power surges and dropouts. The PC is a 3.4GHz
Pentium 4 personal computer running the Windows XP operating
system and the CTLM image analysis software. It includes
1GB of memory, a 120GB disk drive a CDRW to capture
images and a 256 MB video card. The physician¡¯s review
station connects to the operator¡¯s console via a private
100Mbit Ethernet link. |
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CTLM¢ç CT Laser Mammography
System |
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¤ýCLINICAL
APPLICATION |
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The CT Laser Mammography
system (CTLM¢ç) system is intended for use as an adjunct
to mammography in patients who have indeterminatemammographic
findings particularly in dense breasts. It is not intended
for use in cases with clear mammographic or non-mammographic
indications for biopsy.
This device provides the radiologist with additional information
to decide whether a biopsy is necessary.Many countries
have approved the CTLM, although it is not yet approved
for sale in the USA. |
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PRINTERS |
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Codonics Horizon¢ç Ci or
Codonics Horizon¢ç SF (Recommended)
The Horizon¢ç Ci is an intelligent, desktop dry film
imager that produces superior diagnostic quality medical
films as well as color and grayscale paper images fast,
conveniently and affordably. The imager is compatible
with many industry standard protocols including DICOM
and Windows networkprinting. High speed image processing,
networking and spooling are standard.
Specifications Print Technology: Dye-diffusion and direct
thermal Spatial Resolution: 320 dpi (12.6 pixels/mm)
Throughput: Up to 100 films per hour Grayscale Contrast
Resolution: 12 bits (4096)
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Epson 1280 |
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The Epson Stylus Photo 1280
ink jet printer is the ideal large format choice for superior
BorderFree photo quality prints of up to 13¡± x 44¡±. 6-color
2880 x 720 dpi results Continuous tone quality for prints.
BorderFree photo printing Prints 4¡± x 6,¡± 5¡± x 7,¡± 8¡±
x 10,¡± letter, 11¡± x 14¡±
enlargements and 13¡± x 44¡± panoramas ¡°Unvisible¡± 4-picoliter
variable-sized ink droplets - Prints 8¡± x 10¡± prints in
less than two minutes. Water-resistant and lightfast media.
Water-resistant prints on EPSON Premium Glossy Photo Paper
and EPSON Photo Paper. Epson Stylus Photo 1280 is Windows
and Macintosh compatible. |
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EPSON Stylus
Photo 1290S |
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The EPSON Stylus Photo 1290S
inkjet printer provides lightfast 6-colour Photo Reproduction
Quality.
The Stylus Photo 1290S becomes a desktop photo lab printing
everything from portfolios & proofs to letters &
web pages, delivering edge to edge output without the
need for cropping. The Stylus Photo 1290S includes support
for the Universal Serial Bus, fully supported by Microsoft
Windows 98, Windows ME, Windows 2000 & Apple iMac,
G3 & G4. |
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CLASSIFICATION |
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The CTLM¢ç system is classified
by Underwriter¡¯s
Laboratories as a class I, type B device ordinary equipment
in continuous operation with intermittent loading. The
use
of flammable anesthetics or oxidizing gases, such as
nitrous oxide (N2O) and oxygen (O2), should be avoided.
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¤ýSAFETY
(ELECTRICAL/MECHANICAL/LASER) |
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EN 60601-1 |
Medical
Electrical Equipment,
Part 1: General requirements
for safety. |
UL 2601-1 |
Standard
for Safety of Medical
Equipment, Part 1: General
requirements for Safety, Second Edition |
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EN
60601-1-1 |
Medical Electrical Equipment,
Part 1: General requirements
for safety, Collateral standard:
Safety requirements for
medical electrical systems. |
EN
540 |
Clinical investigation of medical
devices
for human subjects. |
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EN 60601-2-22
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Medical Electrical
Equipment,
Part 2: Particular requirements
for the safety of diagnostic and
therapeutic laser equipment. |
FDA |
21 Code of Federal
Regulations, Parts
900, 1010, 1020.10, 1040 |
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IEC
60825-1 |
Safety of Laser Products,
Part 1: Equipment
classification, requirements
and user¡¯s guide. |
Canada |
CAN/CSA-C22.2 No. 601.1-M90: Medical
Electrical Equipment, Part 1: General
Requirements for Safety. |
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EN
60950 |
Safety of Information
Technology Equipment
Including Business
Equipment. |
Europe |
93/42/EEC: Council
Directive
Concerning Medical Devices
Medical electrical equipment. |
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EMC |
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| EN
60601-1-2 |
Medical electrical
equipment. Part 1: General requirements for safety
2. Collateral standard: Electromagnetic compatibility
- requirements and tests. |
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PROGRAMMABLE
ELECTRICAL SYSTEMS (SOFTWARE) |
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| EN
60601-1-4 |
Medical electrical
equipment. Part 1: General requirements for safety
4.Collateral standard: Programmable electrical medical
systems. |
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QUALITY ASSURANCE
SYSTEMS |
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| ISO
9001: 2000 |
Quality
Management Systems Requirements |
| ISO
13485 |
2003 Quality
Systems - Medical devices |
| ISO
13485 |
2003 CMDCAS Canadian
Medical Device Conformity Assessment System Quality
Systems Medical devices |
| CE
Certification |
Full Quality
Assurance System Approval Certification CE 0843
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¤ýDISPLAY
AND PRINTER SET-UP AND QUALIFICATION |
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SMPTE RP 133-1999, Specifications
for Medical Diagnostic Imaging Test Pattern for Television
Monitors and Hard-Copy Recording Cameras (R1999) |
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RISK ASSESSMENT |
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ISO
14971 |
Medical
devices - risk management |
IEC
1025 |
Fault tree analysis
(FTA) |
IEC
812 |
analysis (FMEA)Analysis
techniques for System reliability
Procedure for failure modes and effects
failure modes and
effects criticality analysis (FMECA) |
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¤ýADDITIONAL
MARKINGS / SYMBOLS / TERMINOLOGY / DOCUMENTATION |
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EN
980 |
Terminology, symbols and information
provided with medical devices. Graphical
symbols for use in the labeling of
medical devices. |
EN
1041 |
Terminology, symbols
and information
provided with medical devices. |
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LICENSES |
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| FDA
Certification of Exportability |
4875-9-2003 |
Canada
Medical Device License# |
63242 |
| People¡¯s
Republic of China |
REG. No: SFDA(I) 20043241646 |
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Available Model(s):
CTLM¢ç System 1020 100003
(Not Yet Available in the United States) |
CTLM¢ç
System
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Cat.
No. |
| Scanning Bed Model 1020
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100011 |
| Operator¡¯s Console Model 1020 |
100027 |
| Physician Review Station |
(110VAC) 100032 |
| Physician Review Station |
(220VAC) 100033 |
| Printer
Options |
Cat.
No. |
| Codonics Horizon Ci, 8 x 10 |
160362 |
| Codonics Horizon SF, 14 x 17 |
160363 |
| Epson Photo 1280, (110VAC) |
160360 |
| Epson 1290S, (220VAC) |
160361 |
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