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Philips Sectra Microdose l30

Technical specification

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0% found this document useful (0 votes)
948 views28 pages

Philips Sectra Microdose l30

Technical specification

Uploaded by

Игорь Ч
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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Technical Specification

Sectra MicroDose Mammography L30


Software 8.3
Technical Specification – Sectra MicroDose Mammography L30, Software 8.3

Technical Specification -
Sectra MicroDose Mammography L30
Software 8.3

As part of our commitment to providing the highest quality products and services, we would
like to encourage feedback on the quality of this documentation.

If you think we can improve this document in any way, please send your suggestions to
info.imtec@sectra.se

Document Title Technical Specification - Sectra MicroDose Mammography L30


Software 8.3
Revision 1007996 H
Date 2010-10-22

1007996 H 2 (28) © Sectra 2010


Technical Specification – Sectra MicroDose Mammography L30, Software 8.3

Contents
1.  Introduction..................................................................................................................... 4 
1.1  Purpose ...................................................................................................................... 4 
1.2  Scope ......................................................................................................................... 4 
1.3  Intended readers ........................................................................................................ 4 
1.4  Language ................................................................................................................... 4 
1.5  Chapter overview ...................................................................................................... 4 
1.6  Symbols Used in This Document .............................................................................. 4 
1.7  References ................................................................................................................. 5 
2.  Technical specification of the mammography stand ................................................... 6 
2.1  Model and manufacturer ........................................................................................... 6 
2.2  Regulatory requirements ........................................................................................... 6 
2.3  Electromagnetic compatibility .................................................................................. 7 
2.4  Installation.................................................................................................................9 
2.5  Electrical data .......................................................................................................... 10 
2.6  Environment ............................................................................................................ 11 
2.7  Heat dissipation and cooling ................................................................................... 12 
2.8  Measures and weights ............................................................................................. 13 
2.9  Compression............................................................................................................ 16 
2.10  X-ray source ............................................................................................................ 16 
2.11  X-ray radiation and X-ray protection ...................................................................... 17 
2.11.1  Designated zone of occupancy............................................................................ 18 
2.12  Generator................................................................................................................. 19 
2.13  Exposure.................................................................................................................. 20 
2.14  Detector and image parameters ............................................................................... 21 
2.15  Acquisition Workstation ......................................................................................... 22 
2.16  Labels ...................................................................................................................... 24 

1007996 H 3 (28) © Sectra 2010


Technical Specification – Sectra MicroDose Mammography L30, Software 8.3

1. Introduction
1.1 Purpose
The purpose of this document is to supply the reader with technical data for the Sectra
MicroDose Mammography™ L30 modality.

1.2 Scope
The information in this document applies to the Sectra MicroDose Mammography L30
modality.

1.3 Intended readers


This document is intended for persons requiring technical data for the Sectra MicroDose
Mammography L30 modality. For full understanding of some of the chapters the intended
reader is required the knowledge level of an engineer.

1.4 Language
This document was originally written in English (UK).
In case of uncertainties regarding the content in translated versions of this document, it is the
English (UK) version (document number: 1007996) that is to be regarded as the original.

1.5 Chapter overview


Chapter 1 – Introduction to this document
Chapter 2 – Technical specification of the mammography stand, standard configuration (for
screening)

1.6 Symbols Used in This Document


Warning!
Warning is used when severe danger for patient, personnel or system
exists.

Caution! Caution is used when danger for patient, personnel or system exists.

Notice Notice is used to underline information of importance.

Exposure

The exposure symbol is used when an exposure is made.

1007996 H 4 (28) © Sectra 2010


Technical Specification – Sectra MicroDose Mammography L30, Software 8.3

1.7 References
[1] European Guidelines for Quality Assurance in Breast Screening and Diagnosis, 4th
Edition, 2006.
[2] S. Eklund, A. Thilander, W. Leitz, S. Mattson, "The impact of anatomic variations on
absorbed radiation doses in mammography," Radiat. Prot. Dosim. 49, 167 -17 0 (1993).
[3] K. C. Young, M. L. Ramsdale, and F. Bignell, "Review of dosimetric methods for
mammography in the UK breast screening programme," Radiat. Prot. Dosim. 80, 183-
186 (1998).
[4] B. Heddson, K. Rönnow, M. Olsson, D. P. Miller, “Digital vs. Screen-Film
Mammography: A Retrospective Comparison in a Population-Based Screening
Program”, accepted for publication in the European Journal of Radiology.
[5] Validation of mobile mammography vehicles, the Sectra Mamea AB document DOC-
JLUG-7C3CU8.

1007996 H 5 (28) © Sectra 2010


Technical Specification – Sectra MicroDose Mammography L30, Software 8.3

2. Technical specification of the mammography


stand
Sectra Imtec AB reserves the right to make necessary changes and amendments to the
specification below.

2.1 Model and manufacturer


Model information
Model name Sectra MicroDose Mammography L30
Manufacturer Sectra Imtec AB
Teknikringen 20
SE 583 30 Linköping
Sweden

2.2 Regulatory requirements


European requirements
CE labelling Class IIb. ”Council Directive 93/42/EEC”
concerning medical devices. The product is
labelled with the CE mark with identification
number 0434 which authenticates the
compliance with the directive.
National and international standards
The system is tested according to the IEC 60601-1: 1988 and A1+A21
following standards. IEC 60601-1-2:2001
IEC 60601-1-3:1994
IEC 60601-1-4:1996
IEC 60601-2-28:1993
IEC 60601-2-32:19942
IEC 60601-2-45:2001
Equipment classification (according to IEC 60601-1 §5):
- Type of protection against electrical shock: Class I equipment
- Degree of protection against electrical Type B
shock:
- Degree of protection against harmful Ordinary equipment
ingress of water:
- Mode of operation: Continuous operation with intermittent
loading, permanent installation.
Non-sterilizable equipment
Equipment not suitable for use in the presence of a flammable anaesthetic mixture with air or
with oxygen or with nitrous oxide.

1
The protective earth impedance between acquisition workstation and incoming protective earth is
about 130 mΩ, which exceeds the prescribed maximum level of 100mΩ. The acquisition workstation is
connected to floating voltage and the impedance between acquisition workstation and fixed mains
switch is about 135 mΩ (prescribed maximum level 200 mΩ).
2
Note: Sectra MicroDose Mammography L30 is equipped with auto positioning (rotation) for the C-
arm, which is a violation towards the standard IEC 60601-2-32; 22.4.1. The system is however
provided with collision protection means and meets the requirement for CE-marking.

1007996 H 6 (28) © Sectra 2010


Technical Specification – Sectra MicroDose Mammography L30, Software 8.3

2.3 Electromagnetic compatibility

The use of accessories, transducers and cables other than those specified
Caution! by Sectra or sold by Sectra as replacement parts, may result in increased
emissions or decreased immunity of the L30 system.

Electromagnetic emissions
Model L30 is intended for use in the electromagnetic environment specified below. The
customer or the user of model L30 should assure that it is used in such an environment.
Emission test Compliance Electromagnetic environment –
guidance
RF emissions Group 1 The L30 uses RF energy only for its
CISPR 11 internal function. Therefore, its RF
emissions are very low and not likely
to cause any interference in nearby
electronic equipment.
RF emissions Class B
CISPR 11
Harmonic emissions Not applicable Model L30 is classified as
IEC 61000-3-2 professional equipment and has an
active power consumption > 1000W at
normal load. According to standards
the limits are not applicable.
Voltage fluctuations / Complies
flicker emissions
IEC 61000-3-3

Electromagnetic immunity
Model L30 is intended for use in the electromagnetic environment specified below. The
customer or the user of model L30 should assure that it is used in such an environment.
Immunity test Compliance level Electromagnetic environment –
guidance
Electrostatic discharge Up to 6 kV contact
(ESD) discharge and 8 kV
IEC 61000-4-2 air discharge
Electrical fast transient / 2 kV for power
burst supply lines
IEC 61000-4-4
Surge 1 kV differential
IEC 61000-4-5 mode, 2 kV
common mode

1007996 H 7 (28) © Sectra 2010


Technical Specification – Sectra MicroDose Mammography L30, Software 8.3

Electromagnetic immunity
Portable and mobile RF
communications equipment should be
used no closer to any part of the L30,
including cables, than the
recommended separation distance
calculated from the equation
applicable to the frequency of the
transmitter.

Conducted disturbances V1 =10 V and 80% Recommended separation distance


induced by RF fields AM modulation
IEC 61000-4-6. with 1 kHz at
(V1) frequency range
0,15 – 80 MHz

Radiated disturbances 10 V/m and 80%


induced by RF fields AM modulation
IEC 61000-4-3 with 1 kHz at
(E1) frequency range
80-2500 MHz

E1 = 10 V/m P = maximum output power rating of


the transmitter in watts (W) according
to the transmitter manufacturer
d = recommended separation distance
in metres (m)

Field strengths from fixed RF


transmitters, as determined by an
electromagnetic site survey3 should be
less than the compliance level in each
frequency range. 4
Interference may occur in the vicinity
of equipment marked with the
following symbol:

Voltage dips, short >95% dip for 10 Power loss may result in unwanted
interruptions and voltage ms. 60% dip for 100 power off of model L30. In such cases
variations on power supply ms. 30% dip for 500 re-calibration of the system is
input lines ms. necessary.
IEC 61000-4-11

3
Note: Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast
cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to
fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field
strength in the location in which the L30 is used exceeds the applicable RF compliance level above, the
L30 should be observed to verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as reorienting or relocating the L30.
4
Note: Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m.

1007996 H 8 (28) © Sectra 2010


Technical Specification – Sectra MicroDose Mammography L30, Software 8.3

Electromagnetic immunity
Power frequency (50/60 N/A The L30 is not sensitive for power
Hz) magnetic field frequency magnetic fields.
IEC 61000-4-8

Electromagnetic immunity

2.4 Installation
Installation information
Installation and service Only personnel certified by Sectra may perform
installation and service of the equipment.

Radiation protection Installation must be done in accordance with local


radiation protection regulations.

1007996 H 9 (28) © Sectra 2010


Technical Specification – Sectra MicroDose Mammography L30, Software 8.3

2.5 Electrical data


Electrical Requirements
Input mains connection 380/400/415 VAC 50Hz
Three phase (protective earth + 3 phases)
Fuse 32 A
The electrical connection of the equipment shall be permanent
Fixed mains switch External, isolated 100 A.
Approved according to IEC 328 and IEC 447. The fixed
mains switch shall cut supply current by one single action,
and shall be possible to lock in OFF mode. The fixed mains
switch shall be a mechanical switch, and shall be placed in
immediate proximity to the side cabinet. Sectra
recommends that, if the side cabinet is not placed in the
examination room, an additional switch is placed in the
examination room.
Input impedance Maximum 0.4Ω
Peak power 12 kVA
Average power at normal duty cycle 2.5 kVA
Duty cycle A 7 second exposure / minute at 35 kV, 200 mA. (Average
during one hour.)
Power supply cord Required cross sectional area: 10 mm²
The power supply cord shall comply with IEC 60245 or
IEC 60227. Stranded conductors shall not be soldered.

The cord delivered with the system is approximately 5 m


(from the cable outlet at the backside of the side cabinet).
The diameter is approximately 20 mm.
Input mains connection, network isolation, galvanic isolation
Network isolation unit, when using network connection Alternative 3 or
Alternative 4 (see 2.15).
Input mains connection 100-240 V AC, 50-60Hz, single phase
Galvanic isolation It is important that the system (except for mains supply) is
galvanic isolated from the surrounding. For example water
connections, the floor in the examination room and when
the system is bolted to the floor of a trailer chassis.

1007996 H 10 (28) © Sectra 2010


Technical Specification – Sectra MicroDose Mammography L30, Software 8.3

2.6 Environment
Operating environment - Mammography stand & Acquisition workstation
Temperature +10 C to +30 C (at maximum workflow).
Temperature change 3 C / hour
Humidity 30% to 75 % (non condensing)
Atmospheric pressure 700 hPa to 1060 hPa
Mechanically active substances like dust and Similar levels to a normal office
sand environment, i.e. without special precautions
to minimize the presence of sand or dust, but
is not situated in proximity to sources of sand
or dust.
Operating environment - Side cabinet
Temperature +10 C to +30 C (maximum work flow).
Temperature change 3 C / hour
Humidity 30% to 75 % (non condensing)
Atmospheric pressure 700 hPa to 1060 hPa
Mechanically active substances like dust and Similar levels to a normal office
sand environment, i.e. without special precautions
to minimize the presence of sand or dust, but
is not situated in proximity to sources of sand
or dust.
Mobile Installations
Vehicle requirements See [5]
Controlled area
Access to the equipment must be restricted in accordance with local regulations.
Transport and storage
Temperature +5 C to +30 C
-10 C to +50 C, less than 1 day
Humidity 10% to 75% (non condensing)
95% max, less than 2 weeks
Atmospheric pressure 500 hPa to 1060 hPa
Mechanically active substances like dust and Similar levels to a normal indoor
sand environment, i.e. without special precautions
to minimize the presence of sand or dust, but
is not situated in proximity to sources of sand
or dust.
Fire-extinguisher
Type Powder

1007996 H 11 (28) © Sectra 2010


Technical Specification – Sectra MicroDose Mammography L30, Software 8.3

2.7 Heat dissipation and cooling


Main cabinet with AW table
Heat dissipation (total) for both air and 0.7 kW (maximum work flow)
water cooled option. 0.4 kW (stand-by mode)
Side cabinet:
Air cooling (standard configuration)
2.5 kW (maximum work flow)
Heat dissipation specification (total)
1.5 kW (stand-by mode)
Side cabinet :
Water cooling (municipal cooling network)
2.5 kW (maximum work flow)
Capacity of water cooling
1.5 kW (stand-by mode)
Water cooling (municipal cooling
network)

Example: If the enclosure temperature is 25°C, the


cooling capacity of the water cooler will be 2.5 kW
if the water flow is 350 litres/hour, at 100 kPa
(nominal) and the incoming water temperature is
approximately 6°C.

Maximum water flow: 400 litres/hour


Water pressure: 1-10 bar (100 – 1000 kPa)

Chiller fittings The chiller has G 1/2" (R15) fittings.

1007996 H 12 (28) © Sectra 2010


Technical Specification – Sectra MicroDose Mammography L30, Software 8.3

2.8 Measures and weights

Figure 1 Measures of Mammography stand.

1007996 H 13 (28) © Sectra 2010


Technical Specification – Sectra MicroDose Mammography L30, Software 8.3

Figure 2 Measures of Side cabinet.


Left: Air cooling (standard) Right: Water cooling (optional)

Figure 3 Measures of Acquisition Workstation table and radiation protection shield.

Mammography stand
Measures See Figure 1
Weight 260 kg
Measures with packaging 800x1800 mm, height 1600 mm
Weight with packaging 320 kg
Side cabinet
Measures with standard cooling See Figure 2, left
Measures with optional cooling See Figure 2, right
Weight with standard cooling 260 kg
Weight with optional cooling 260 kg
Measures with packaging 800x1200 mm, height 1600 mm
Weight with packaging 300 kg

1007996 H 14 (28) © Sectra 2010


Technical Specification – Sectra MicroDose Mammography L30, Software 8.3

C-arm
Height (from floor to patient support) 760 – 1380 mm
Speed of rotational motion 10/second
Speed of vertical movement 50 mm/s
Rotation - standard configuration -100 to + 180
Automatic positioning (including isocentric Dx CC, Sin CC,
C-arm rotation) Dx MLO, Sin MLO,
Dx LM, Sin LM
Limitation of C-arm movement (vertical At compression force greater than 50 N,
movement and rotation) C-arm movement is not possible.
Collision protection Yes
Accuracy of display of rotation angle ± 1°
SID (Source Image Distance) 660 mm
Source to patient support distance 640 mm
Missed tissue at chest wall 5 mm
Radiation protection shield
Measures See Figure 3
Weight (lead glass shield) 29.5 kg
Acquisition Workstation table
Measures See Figure 3
Weight 75 kg
Network isolation
Network isolation unit, when using network connection Alternative 3 or Alternative 4 (see
2.15). To be mounted close to mains electrical outlet.
Measures Height: 25 mm
Width: 105 mm
Depth: 95 mm
Weight 0.27 kg
Placement
Maximum distance between mammography Cable length 6 m.
stand and Side Cabinet
(from cable outlet to cable outlet).
Maximum distance between mammography Cable length 9.5 m
stand and Acquisition workstation table (can be adjusted to 19.5 m at request)
(from cable outlet to cable outlet).
Required free space at both sides of the 600 mm
C-arm rotated 90° (either to the left or to the
right).
Required free space around the side cabinet 200 mm (on all sides, for air circulation)
The side cabinet must be placed at the same level as the mammography stand, i.e. it cannot be
Placed e.g. one floor upstairs.
A designated significant zone of occupancy for the operator is required during exposing. The
size of this area shall be at least 60x60x200 cm.
Cable routing
Total diameter of hoses and cables including Minimum diameter 75 mm.
connectors between side cabinet and main
cabinet.
Total diameter of cables including connectors Minimum diameter 60 mm.
between main cabinet and AW-table.

1007996 H 15 (28) © Sectra 2010


Technical Specification – Sectra MicroDose Mammography L30, Software 8.3

2.9 Compression
Compression
Motion 0-150 mm
Maximum compression height at exposure 100 mm (for standard compression paddle)
Accuracy of display of breast thickness ± 2 mm
First stop limit for compression 12 daN (configurable 0-20 daN)
Compression force 0 – 200 N
Compression paddles - Standard
- High edge
- Spot (optional)
- Low Spot (optional)
- Small (optional)
- Medium (optional)
- Matrix (optional)
- Window (optional)
Release of compression - Pedals that control the movement of the
compression paddle.
- Automatic release after exposure. (Unless
the “Keep compression” option has been
chosen.)
- Release of compression force in case of
power loss.
- Release of compression force if the
emergency stop is activated.
Accuracy of display of compression force. ± 20 N

2.10 X-ray source


X-ray tube
Maximum tube voltage 40 kVp
Maximum power to the anode 6.8 kW (at 38 kVp, 180 mA)
Maximum tube current at maximum tube 170 mA at 40 kVp
voltage
Maximum tube current 180 mA
Maximum tube voltage at maximum tube 38 kVp at 180 mA
current
Maximum allowed energy deposition to the 5220 kJ/h (130 500 mAs/h at 40 kVp)
anode per hour
Anode material Tungsten
Anode disc size  102 mm
Anode rotation speed 10800 RPM
Focal spot size - standard configuration 0.3 according to IEC 60336
Anode angle 16
(the tube is mounted with a tilt of 7 in a
way that 23 angle is achieved relative the
reference axis)
Anode heat capacity 445kJ (600 kHU)
Maximum heat radiated from the anode 1.5 kW (121.5 kHU/min)
Cooling Oil-air exchanger (fan)
Accompanying documentation
Data sheet X-ray tube Technical Data sheet for Varian RAD-70-
type tube

1007996 H 16 (28) © Sectra 2010


Technical Specification – Sectra MicroDose Mammography L30, Software 8.3

Service manual X-ray tube X-ray tube Service Manual – Varian #14423
Service report X-ray tube Mammography Tube Service Report –
Varian #4989

2.11 X-ray radiation and X-ray protection


Relation between mAseff and conventional mAs
 mAs is tube current  exposure time of x-ray tube (not to be confused with the exposure time
for a point in the image field).
 Effective mAs (mAseff) is the mAs corrected for the fraction of open area in the collimator in
relation to the total scan length, i.e. this is the mAs that a point in the image plane experiences
during a scan.
X-ray radiation
Inherent filtration from the X-ray tube 0.76 mm Be
Added filter 1004803 0.40 mm Al
Total filtration (including collimator cradle 0.46 mm Al equivalent at 30 kVp
1004897)
Half-value layer after filtering without compression 26 kVp, 0.27 mm Al
paddle 32 kVp, 0.34 mm Al
(a 3 mm compression paddle increases HVL with 38 kVp, 0.41 mm Al
0.12 mm Al at 30 kVp) (values in-between can be linearly
interpolated)
Air kerma typical values 45 mm above the patient 0.09 mGy/mAseff at 26 kVp
support and 60 mm from the edge of the patient 0.15 mGy/ mAseff at 32 kVp
support, compression paddle present. 0.22 mGy/ mAseff at 38 kVp
(values in-between can be linearly
interpolated)
Tube voltage, tube current and exposure time 40 kVp, 170 mA, 15 s
providing maximum radiation leakage
Dose levels
Breast thickness C100 dose C120 dose Acceptable Achievable
setting setting level [1] level [1]
3 cm 0.34 – 0.41 0.60 – 0.74 <1.2 <0.9
5 cm 0.40 – 0.49 0.68 – 0.84 <2.3 <1.8
8 cm 0.9 – 1.1 1.2 – 1.4 <5.7 <4.6
Population-averaged 0.5 – 0.6 0.8 – 1.0 n/a n/a
Table 1: Measured AGD (mGy) and limiting values from European guidelines [1]. Confidence
intervals are 2 standard deviations. Also included are population-based dose values, i.e. dose
averaged over a measured breast thickness distribution. Conversion factors were taken from *)
*) Further factors for the estimation of mean glandular dose using the United Kingdom,
European and IAEA breast dosimetry protocols, D R Dance, K C Young and R E van Engen, Phys Med Biol,
54 (2009), 4361-4372.
C100 The C100 dose configuration corresponds to a set of target image quality figures
that meet the so-called Acceptable limiting values in the European Guidelines [1].
C120 This dose configuration corresponds to a set of image quality figures that provide
20% higher SDNR (a.k.a. CNR) than the C100 setting. This is equivalent to being
able to see 20% thinner objects of the same size.
C200 This dose level can only be used with the spot compression paddle and small image
field. SDNR is roughly doubled and the dose four times higher compared to C100.
Radiation reference axis
The radiation reference axis is pointed towards the edge of the digital detector closest to the chest
wall. The radiation is collimated in a way that no radiation comes outside the edge of the patient
support that is close to the chest wall.
Patient support attenuation

1007996 H 17 (28) © Sectra 2010


Technical Specification – Sectra MicroDose Mammography L30, Software 8.3

Patient support 0.05 mm Al equivalence at 30kVp


(W anode and HVL 0.3 mm Al)
X-ray radiation protection
Protective lead glass 0.5 mm Pb equivalent at 55-120kVp

2.11.1 Designated zone of occupancy


A designated significant zone of occupancy for the operator is required during exposing.
The size shall be at least 60x60x200 cm (W x D x H).

Personnel working with the equipment should occupy this zone of occupancy during
exposure. Figure 4 defines the zone of occupancy.

Figure 4 The zone of occupancy.

The radiation protection shield should be positioned in accordance with Figure 4 to minimize
the radiation exposure to the operator.

1007996 H 18 (28) © Sectra 2010


Technical Specification – Sectra MicroDose Mammography L30, Software 8.3

Figure 5 The figure illustrates the intensity profile of the scattered radiation as function of
height above the floor, with and without the protective lead glass. The data in the
figure is normalised to 30,000 exposures. The measurements were performed
120 cm from the scattering volume. 5x30x30 cm3 PMMA in the radiation field
was used as scattering volume. The exposure parameters were 40 kVp, 170 mA
and 7 s (40 kVp, 10.4 mAs).

2.12 Generator
High voltage generator
Power 9 kW
kV range 20 – 40 kVp
The system is typically calibrated for only 5
different kVp values.
mA range 50 – 210 mA
Maximum mAs 4000 mAs
Ripple Max. 1%

1007996 H 19 (28) © Sectra 2010


Technical Specification – Sectra MicroDose Mammography L30, Software 8.3

2.13 Exposure
Exposure control
Exposure settings SmartAEC™ , Automatic or Manual,
where SmartAEC and Automatic are
different types of automatic exposure modes.
Accuracy of kV indicator ± 2.0 %
Accuracy of mAs indicator ± 10 %
Termination of exposure The X-ray exposure is terminated when any
of the following limits are reached:
- the end of the image field (primary)
- timeout of scan-time + safety margin
(secondary)
Automatic exposure control
kVp-range 26 – 38 kVp
mAs-range Range of effective mAs:
Standard Spot image
image field field
26 kVp 5.7 – 23 12 – 55
29 kVp 6.2 – 24 13 – 60
32 kVp 6.5 – 26 13 – 63
35 kVp 6.5 – 26 13 – 63
38 kVp 6.5 – 26 13 – 63
SmartAEC™ SmartAEC exposure mode continuously
adjusts the exposure, during the image scan,
according to feedback from the detector.

SmartAEC – acceptable objects For SmartAEC exposure mode, the following


objects may be within the AEC area:
 Breast
 Hand
 Skin markers
 Bracketing wires
 Standard compression paddle
 Medium compression paddle
 Small compression paddle
 High edge compression paddle

1007996 H 20 (28) © Sectra 2010


Technical Specification – Sectra MicroDose Mammography L30, Software 8.3

SmartAEC– erroneous objects For SmartAEC exposure mode, other objects


than the above mentioned within the AEC
sensor area, may cause increased patient
dose. These foreign objects should be placed
outside the AEC sensor area or should be
exposed with Automatic or Manual exposure.

Automatic Exposure parameters (kV and mAs) are set


automatically based on measured thickness
during compression.
Scanning technology
Scan-time 4 – 16.5 s
Scatter to primary ratio < 0.05

2.14 Detector and image parameters


Digital detector
Detector technology Photon Counting
Detector material Crystalline silicon
Dynamic resolution 1 photon
Absorption efficiency 90% for 30 kVp and a 45 mm breast
Dynamic range 15 bits
Pixel size 50 µm
Nyquist frequency 10 lp/mm
Field of View (FOV) 240 mm × 260 mm (standard mode)
240 mm × 126 mm (configurable only with
spot compression)
Image size (data) ~50 Mb
(uncompressed, standard configuration)
Low frequency detective quantum efficiency >0.65 at 1 mm-1 (measured according to the
standard IEC 62220-1-2)
High frequency detective quantum efficiency >0.24 at 4 mm-1 (measured according to the
standard IEC 62220-1-2 and averaged from
scan-direction and perpendicular direction)
Modulation transfer function >0.45 at 4 mm-1 on patient support
>0.47 at 4 mm-1 45 mm above patient support
(MTF measured 6 cm from chest wall and
laterally centred, and averaged from scan-
direction and perpendicular direction)

1007996 H 21 (28) © Sectra 2010


Technical Specification – Sectra MicroDose Mammography L30, Software 8.3

2.15 Acquisition Workstation


Hardware
Computer PC
CPU Pentium 4 / 3.2 GHz (minimum)
Storage capacity Up to 2500 (breast) images.
Display Standard Display:
 Min 19” with 1 Mpx (1280x1024)

Optional DICOM Displays:


 Min 19” with 1 Mpx (1280x1024)
 Min 21” with 3 Mpx (2048x1536)
Keypad with quick-keys Yes
Keyboard Yes
Mouse Yes
Network connection
Alternative 1, Gigabit fibre network MMF fibre cable 50/125 or 62.5/125 micron,
Alternative 2, 100 Mbps fibre network SC connectors
Alternative 3, Gigabit copper network Category 5 cable
Alternative 4, 100 Mbps copper network RJ45 – RJ45 connectors
Alternative 5, no network connection Support for external disk with specification:
 USB 2.0 interface
 Hard disk based
 No separate power supply
 Minimum storage capacity 160 GB
Software
Operating system Microsoft Windows XP Professional
DICOM SOP Classes supported  Verification as SCU (Service Class User)
 Basic Grayscale Print Management Meta as
SCU (not supported in connection alternative
5)
 Modality Performed Procedure Step (MPPS)
as SCU (not supported in connection
alternative 5)
 Digital Mammography Image Storage - For
Presentation as SCU
 Digital Mammography Image Storage - For
Processing as SCU
 Digital X-Ray Image Storage - For
Presentation as SCU
 Digital X-Ray Image Storage - For Processing
as SCU
 Modality Worklist as SCU
 Storage Commitment Push Model SOP Class
as SCU (not supported in connection
alternative 5)

1007996 H 22 (28) © Sectra 2010


Technical Specification – Sectra MicroDose Mammography L30, Software 8.3

Parameters visible in the digital image Always shown parameters:


shown on the Acquisition Workstation  Side
 Projection
 Image setting (e.g. ”Implant”)
Other parameters are optional, but default for
standard breast images are:
 Patient name
 Patient ID-number
 kV and mAs
 Patient dose (organ dose)
 Compression height
 Image time (exposure)

1007996 H 23 (28) © Sectra 2010


Technical Specification – Sectra MicroDose Mammography L30, Software 8.3

2.16 Labels
(Serial numbers and batch numbers rendered in images are fictive.)

Labelled part Information on label Comment

Three identical labels.


 One visible on the back of the main
cabinet.
 One visible on the outside of the
Complete side cabinet door.
modality
 An extra label is provided
separately. If required by local
regulations, the label is attached to
the inside of the hatch of the
acquisition workstation table.

Two identical labels.


 One visible on the back of the main
Read the
cabinet.
Manual,
Electronic  One visible on the outside of the
Waste & side cabinet door.
Electric Safety,
Class B product

The label is provided separately. If


required by local regulations, the label is
attached to the front of the acquisition
workstation table.
Acquisition
workstation
table (optional)

Label visible on top of


the acquisition workstation table.

Acquisition
workstation
table

1007996 H 24 (28) © Sectra 2010


Technical Specification – Sectra MicroDose Mammography L30, Software 8.3

Labelled part Information on label Comment

Two identical labels.


 One label is attached to the X-ray
tube under the C-arm covers.

X-ray tube and  An extra label is provided


main cabinet separately. If required by local
(optional) regulations, the label is attached
either to the underside of the top
cover of the main cabinet or to the
lower right side of the main cabinet.

Label placed on the laser unit intended


for wire localization.

Laser holder

Label visible on the front side.


X-ray radiation
shield

Filter & Label visible on the mounting device of


Collimator the X-ray tube.
cradle assembly

Standard Label visible on the side of the


compression compression paddle.
paddle

Spot Label visible on the side of the


compression compression paddle.
paddle

Small Label visible on the side of the


compression compression paddle.
paddle

Medium Label visible on the side of the


compression compression paddle.
paddle

1007996 H 25 (28) © Sectra 2010


Technical Specification – Sectra MicroDose Mammography L30, Software 8.3

Labelled part Information on label Comment

High edge Label visible on the side of the


compression compression paddle.
paddle

Matrix Label visible on the side of the


compression compression paddle.
paddle

Window Label visible on the side of the


compression compression paddle.
paddle

Low Spot Label visible on the side of the


compression compression paddle.
paddle

Label visible on the side of the Face


Face protection protection shield.
shield

Acquisition Label visible on the front side of the


workstation AWP.
table

Label visible on the side of the


Pre Collimator Collimator cradle assembly.
with Cradle

Label visible on the mounting device of


X-ray tube the X-ray tube.

Label visible on the laser unit intended


Laser holder for wire localization.

Label visible on the guidance bracket


Guidance intended for wire localization.
bracket

1007996 H 26 (28) © Sectra 2010


Technical Specification – Sectra MicroDose Mammography L30, Software 8.3

Labelled part Information on label Comment

Label visible on the inside of the side


cabinet door.

Side cabinet air


L30 assembly

Label mounted on the inside of the side


cabinet door.

Side cabinet
water cooling
L30 assembly

Daily quality Label visible on the front side.


control
phantom

Label visible on the front side.


Calibration
phantom

Several identical labels visible outside


each of the transport packages.

Transport
package

1007996 H 27 (28) © Sectra 2010


Manufacturer
Sectra Imtec AB
Teknikringen 20
SE-583 30 Linköping, Sweden
Phone: +46 13 23 52 00
E-mail: info.imtec@sectra.se

www.sectra.com/medical

For local contact information, visit


www.sectra.com/medical/contact

© Sectra 2010

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