Philips Sectra Microdose l30
Philips Sectra Microdose l30
Technical Specification -
Sectra MicroDose Mammography L30
Software 8.3
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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
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.
1.4 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.
Caution! Caution is used when danger for patient, personnel or system exists.
Exposure
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.
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.
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
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.
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.
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.
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
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
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.
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
Service manual X-ray tube X-ray tube Service Manual – Varian #14423
Service report X-ray tube Mammography Tube Service Report –
Varian #4989
Personnel working with the equipment should occupy this zone of occupancy during
exposure. Figure 4 defines the zone of occupancy.
The radiation protection shield should be positioned in accordance with Figure 4 to minimize
the radiation exposure to the operator.
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%
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.
2.16 Labels
(Serial numbers and batch numbers rendered in images are fictive.)
Acquisition
workstation
table
Laser holder
Side cabinet
water cooling
L30 assembly
Transport
package
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