Beruflich Dokumente
Kultur Dokumente
Introduction
Important Note . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Range of Application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Safety
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Checks, Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Installation, Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Warning Note . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Operation
Preparations Before Start . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Start-Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Basic Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Setting the Exposure Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Manual Mode (mAs mode) . . . . . . . . . . . . . . . . . . . . . . . . . . 29
AEC Mode (Automatic Exposure Control) . . . . . . . . . . . . . . . . . . 29
Program Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Automatic Program Selection Mode OPDOSE . . . . . . . . . . . . . . . . 30
Quick Guide for OPDOSE . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Program Values as Preset from the Factory . . . . . . . . . . . . . . . . . 31
Presettings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Pivoted Object-table Arm (MAMMOMAT 3000 Nova only) . . . . . . . . . 32
Object Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Removal of Object Table . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Mounting the Object Table . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Hazard Note on Unintentional Decompression . . . . . . . . . . . . . . . . 33
Compression Plate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Removal of Compression Plate . . . . . . . . . . . . . . . . . . . . . . . . 34
Mounting the Compression Plate . . . . . . . . . . . . . . . . . . . . . . 34
Film Marking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Film Cassette . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Insertion of Film Cassette . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Removal of Film Cassette . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Height Adjustment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Positioning the AEC Detector . . . . . . . . . . . . . . . . . . . . . . . . 39
Projection Angle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Face Shield . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Field Light . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Motorized Compression . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Optimized Compression OPCOMP . . . . . . . . . . . . . . . . . . . . . . . . . 44
Guidance for Proper Use of OPCOMP . . . . . . . . . . . . . . . . . . . . 44
Step-by-step Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Manual Compression . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Automatic Decompression . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Error Indication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Temperature Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Shutdown . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
System Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
Emergency Stop . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
Special Cases . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
Spot compression (Option) . . . . . . . . . . . . . . . . . . . . . . . . . . 49
Attaching the External Diaphragm . . . . . . . . . . . . . . . . . . . . . . 49
Magnification (Option) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
Biopsy Attachment with Shadow Cross (Option) . . . . . . . . . . . . . . . 51
2 Operator Manual
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Contents
Protective Measures
Emergency Shutdown Switch . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
Emergency Stop Button . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
Explosion Protection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
Radiation Protection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
Staff Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
Patient Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
Checking the Automatic Exposure Control (AEC) . . . . . . . . . . . . . . . . . 56
Mechanical Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
Hazard Areas . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
Risk of Stumbling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
Safety-relevant Parts Subject to Wear . . . . . . . . . . . . . . . . . . . . . . . 58
Waste Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
Radiation Protection Material . . . . . . . . . . . . . . . . . . . . . . . . 59
Other Metal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
Transformer Oil, type Shell 4655 . . . . . . . . . . . . . . . . . . . . . . 59
Plastic Material . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
Electrolytic Capacitors . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
Mechanical Hazard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
Stereotactic Biopsy Unit (MAMMOMAT 3000 Nova only) . . . . . . . . . 60
Identification Labels
Stand . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
Generator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
Separate Control Console . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
Cleaning, Disinfection
Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
Disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
Technical Specifications
Tube rating charts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
Anode Heating Curves and Cooling curve . . . . . . . . . . . . . . . . . . 66
Cooling and Heating Curves for the X-ray Tube Assembly . . . . . . . . . . 67
Technical Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
Environmental conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
Stand . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74
Generator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
Free-standing Radiation Shield (Option) . . . . . . . . . . . . . . . . . . . 76
Separate Control Console . . . . . . . . . . . . . . . . . . . . . . . . . . 76
Notice concerning electromagnetic compatibility (EMC) . . . . . . . . . . . . . . 77
List of compatible components . . . . . . . . . . . . . . . . . . . . . . . . . . . 82
4 Operator Manual
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Introduction
Introduction
Important Note
Proper use of this equipment presupposes that the operating personnel is thoroughly
familiar with the operating instructions, in particular the sections Safety, Protective
Measures and Function and Safety Check.
If legally-binding regulations govern the installation and/or the operation of the above
equipment, it is the responsibility of the installer or the operator to observe these reg-
ulations.
Range of Application
MAMMOMAT® is a universal system for diagnostic mammography, high volume
screening and stereotactic biopsies (MAMMOMAT 3000 Nova only).
MAM00663
Stand
MAMMOMAT 1000
The X-ray stand is available in two versions:
• Stand with fixed object-table arm for one object table (18x24 cm or
24x30 cm), Mo X-ray tube (molybdenum rotating anode tube) and Mo-filter.
• Same as above, but with Mo/Rh-filter.
M A M M O M AT 1000 M A M M O M AT 1000
NOTE!
NOTICE!
Unless otherwise stated, the illustrations show the stand with pivoted
object-table arm and generator with integrated radiation shield and con-
trol panel.
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Design and Function
Counterweight
MAM00669
Figure 4. Stand with fixed object-table arm Figure 5. Stand with pivoted object-table arm
Generator
The generator is either installed with integrated radiation shield and control panel or
as a separate unit with separately installed control console and radiation shield.
MAM00720
Figure 6. Generator with integrated control panel and radiation shield
MAM00721
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Design and Function
Mo Mo W
kV mAs AEC Mo Rh Rh Program Auto Lim.
WARNING
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Design and Function
Control Panel
The control panel has pressure sensitive control buttons and numeric displays for all
relevant exposure data. Improper equipment conditions resulting in blocked exposure
are indicated by indicator lamps. Error codes are shown on the kV and mAs displays.
Mo Mo W
kV mAs AEC Mo Rh Rh Program Auto Lim.
WARNING
Mo Mo W
kV mAs AEC Mo Rh Rh Program Auto Lim.
WARNING
Decompression button
The control panel in the separate control console has the same layout as the control
panel integrated in the generator, except the ON/OFF buttons, which have been
moved. An extra decompression button has been added to be used in case of release
needed before exposure.
WARNING!
This X-ray unit may be dangerous to patient and operator unless safe
exposure factors and operating instructions are observed.
The control panel has control buttons for the following functions:
mAs / mGy
If the Dose Calculation option is enabled (refer to page 15), the dose
value is shown on the same display as the mAs value.
After an exposure, the mAs value and the dose value will toggle in the
display with a 2 second interval-time, starting with the mAs value. The
values will show until any button on the control panel is pressed. The
dose value is displayed in mGy (milli Gray) and represents the calculat-
ed absorbed glandular dose for the latest exposure.
AEC AEC. These buttons are used to activate AEC mode (Automatic Expo-
sure Control). H stands for high speed and D for detail screens.
H D
Mo Mo W
Mo Rh Rh
Buttons for selection of anode/filter combination
Only the Mo/Mo and the Mo/Rh anode/filter combinations are available
for the MAMMOMAT 1000.
< < Only the Mo/Mo anode/filter combination is available for
MAMMOMAT 1000 systems with single filter.
12 Operator Manual
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Design and Function
Program Auto
Program Mode panel with program buttons for selec-
tion of four different pre-programmed beam qualities
for different intervals of breast thickness.
MAM00380
0/1 Store button ( ) for storing exposure parameters for
each breast thickness interval.
“Auto” button to select/deselect Auto Mode. In Auto
Mode, appropriate program (kV, density, anode/filter
combination and H/D) is automatically suggested.
Exposure release buttons with green indicator light. Both buttons must be
pressed during the entire exposure. This is to ensure that the operator is
standing behind the radiation shield during the exposure.
Option
Exposure release handle on extension cord is available for the separate con-
trol console.
Error Indications
Five indicator lamps on the control panel indicate operator errors.
A) Cassette is missing.
B) The cassette needs to be replaced; it has already been ex-
posed.
NOTE!
NOTICE!
Exposure will be blocked if any of the indicator lamps above are lit.
Exposure Conditions
Focal spot indication. Indicates focus in operation. Small focus is au-
tomatically selected when the magnification table is used.
Green light indicates that the unit is ready for exposure. This indi-
cator has the same function as the green indicator light on the
stand display and in the exposure-release buttons.
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Design and Function
Limit Lamp
Lim.
Fixed light: Limit error
Flashing light: Tube temperature is above normal, but exposures
>0< can still be made.
Should the temperature rise too high, error code "Er 802" will appear
on the control panel. Exposures cannot be made until the X-ray tube
has cooled down (see further section Error Indication, Temperature
Monitoring).
Stand Display
The stand display is placed down in the lower part of the stand.
mm
F o
OC
Compressed thickness.
MAM00389
mm
Angle of swivel-arm system.
+
- Rotation range: Clockwise to +135° and counterclockwise to
-180°. Any change of the preset angle will be displayed for 3 s,
after which the actual angle is displayed again.
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Design and Function
Swivel-arm system
The following components are included in the swivel-arm system:
• X-ray tube assembly
• collimator unit
• compression device
• Pivoted object-table arm with two different object tables
(MAMMOMAT 3000 Nova only), or fixed object-table arm with one object ta-
ble.
MAMMOMAT 1000
5
1 M A M M O M AT 1000
4
6
2
7
3 8
9
16 10
11
4 12
13
14
MAM00670
15
1 5
M A M M O M AT 1000 17
2
17
4 7
8
3
9
6
10
16
11
4 12
13
14
MAM00904
15
17
18 Operator Manual
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Design and Function
11
1
8
2 12
3 13
4 14
5 15
6 16
7 17
8 18
2
19
9
MAM00672
20
10
X-ray Tube
MAMMOMAT 1000
The MAMMOMAT 1000 system can only use the Mo tube with molybdenum rotating
anode and two focal spots.
Collimator Unit
The collimator unit consists of the following components:
• rotating filter disc with molybdenum and rhodium filters
• mirror
• field-light bulb
• internal diaphragms (automatic selection)
Filter disc
The filter disc has either two or three filters, depending on which type of X-ray tube
is used. The MAMMOMAT 1000 with single filter is equipped with a 30 µm molybde-
num stationary filter, riveted to its holder.
Mo tube: Filter disc with two filters; 30 µm molybdenum and 25 µm rhodium
Mo/W tube: Filter disc with three filters; 30 µm molybdenum, 25 µm rhodium and
50 µm rhodium (MAMMOMAT 3000 Nova only).
The filters are riveted to the disc.
Mirror
• The mirror is flipped into the beam path when the field light is switched on.
• The MAMMOMAT 1000 with single filter is equipped with a fixed X-ray
transparent mirror in the beam path.
Field Light
The field light serves as a radiation-field indicator.
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Design and Function
External Diaphragms
When the size of the object table is changed, the appropriate collimator is automati-
cally selected. MAMMOMAT 1000 with single filter uses external diaphragms.
When spot compression is performed, or in stereotactic mode, external diaphragms
shall be used.The stereotactic mode is available for MAMMOMAT 3000 Nova only.
MAM00673
Lever for release of
object-table arm
Object Tables
The object tables are slid onto a base plate. The following object tables can be used
with the MAMMOMAT:
• 24x30 cm with reciprocating grid (Bucky)
• 18x24 cm with reciprocating grid (Bucky)
• Magnification table for 18x24 cm (magnification factor 1.8 or 1.5)
• 24x30 cm without grid
• 18x24 cm without grid
• Stereotactic biopsy unit (MAMMOMAT 3000 Nova only)
All object tables are provided with microswitches in the cassette slot to monitor
whether the cassette is in position or has been replaced after exposure.
All object tables have a keying hole to fit the keying pin mounted in the stand.
Base Plate
The base plate includes the AEC detector, locking mechanism for the object table and
a connector for the electronics. Together with the object table, the base plate func-
tions as a beam stopper.
Film Marking
The film can be marked with data concerning the orientation of the object. Six slidable
labels with different projection designations are provided on the object table. Slide the
label corresponding to the projection used into the beam path, and the projection des-
ignation will be superimposed on the film.
The following film marking labels are supplied as standard:
Lcc = Left cranio-caudal
Lml = Left medio-lateral
Lmlo = Left medio-lateral oblique
R-mlo
MAM00907
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Design and Function
Compression
Foot Switches
Two sets of foot switches for motorized compression and decompression are provid-
ed.
By pressing the right switch (the compression switch), the compression plate is
moved downwards and the field light is switched on.
By pressing the left switch (the decompression switch), the compression plate is
moved upwards.
MAM00029
Figure 18. Foot switches
Manual Compression/Decompression
Compression and decompression can be done manually with the two knobs on the
compression unit.
Automatic Decompression
If automatic decompression is selected (lamp is lit), the breast is
automatically decompressed after an exposure.
The compression plate moves up to a position about 80 mm above
0/1
MAM00031
the breast. To disable this feature, just press the button again.
Compression Plates
A variety of compression plates are available.
NOTE!
NOTICE!
The compression plates are articles of consumption.
MAM00033
NOTE!
NOTICE!
The compression automatically moves upwards, when the object-table
arm is rotated, or when the object table is unlocked.
24 Operator Manual
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Safety
Safety
Maintenance
To ensure the safety of the patients, the operators, and third parties, the equipment
must be checked every 12 months to maintain its reliability and serviceability.
All parts of the unit which, if worn, may create a safety hazard, must be checked by
skilled personnel at regular intervals of at least 12 months, and replaced, if required.
This should be done by the Siemens customer service department within the frame-
work of maintenance.
If national rules or regulations specify more frequent checks and/or maintenance,
such regulations must be observed.
Checks, Test
Before using the equipment for examination, the user must make sure that all safety-
relevant devices function properly and that the unit is ready for operation. Special
attention must be given to checking the displays and pilot lights for proper operation
(visual check).
Perform checks and tests according to the "Function and safety check" check list
page 52.
The radiation indicator may light during operation only while the exposure-release but-
tons are operated. In the event that this indicator lights while these buttons are not
operated, the X-ray system must be shut down at once and customer service must
be notified.
NOTE!
NOTICE!
Intensive use and the utilization of cleaning agents can accelerate the ag-
ing process of the plastic parts of the compression plate, leading to dam-
age and cracking.
Please regularly examine these for possible evidence of wear, particular-
ly on the plate near the chest wall, and replace the compression plate in
due time.
Installation, Repair
Modifications of, or additions to the product must be made in accordance with the le-
gal regulations and generally accepted engineering standards.
As manufacturers, assemblers, installers or importers SIEMENS cannot assume re-
sponsibility for the safety features and for the reliability and performance of the equip-
ment, if:
• installation, equipment expansions, readjustments, modifications or repairs
are not carried out by persons authorized by us.
• components affecting safe operation of the unit are not replaced by original
spare parts in case of a malfunction.
• the electrical installation of the room concerned does not meet the require-
ments of the VDE 0107 regulation, or the corresponding national regulations,
or
• the product is not used in accordance with the instructions for use.
On request, we will make technical documents for the product available to you at a
charge which will be invoiced. This does not imply an authorization to undertake re-
pairs. We accept no responsibility for repairs performed without our expressed writ-
ten approval.
We suggest that you obtain a report indicating the nature and extent of the work per-
formed from the persons carrying out such work, and specify that the report show
any changes in rated parameters or operating ranges, as well as date, the name of the
firm and a signature.
Warning Note
All important safety notes in this document are within frames. The following words
are used as attention marks:
WARNING!
Warning is used to indicate the presence of a hazard which can cause
personal injury or death.
CAUTION!
Caution is used to indicate the presence of a hazard which can cause
damage to the equipment if this is used improperly.
NOTE!
NOTICE!
Notice is used to notify users of operator information which is important
but not hazard-related.
26 Operator Manual
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Operation
Operation
Preparations Before Start
Cleaning
See cleaning and disinfection about methods and recommended cleaning agent.
Start-Up
Press button " " on the control panel to turn the system on. Allow a system warm-
up time of approximately 5 minutes.
Mo Mo W
kV mAs AEC Mo Rh Rh Program Auto Lim.
WARNING
MAM00034
Figure 21. Control panel, system ON
Basic Operation
1. Select table size. The collimator will adjust automatically to the film size which
can be checked with the field light.
NOTE!
NOTICE!
For the MAMMOMAT 1000 with single filter, an external diaphragm
must be used for 18x24 cm object tables.
28 Operator Manual
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Operation
Program Mode
There are four fixed programs for different intervals of breast thickness.
• Select desired program by pressing the corresponding program button.
• It is possible to store desired kV setting, density correction and anode/filter
combination with each one of the pre-programmed breast thicknesses. To
do this, first press the store ( ) button and then the program button con-
cerned. Keep both buttons pressed until the program button stops flashing
(approx. 5 s).
• H or D selection is included in the parameters stored in the four programs
used in Automatic Program Selection mode.
The H/D selection can be reprogrammed as needed (if panel programming is
enabled).
To change H/D without changing the other programmed parameters, use
program mode to choose kV, anode/filter and density adjustment, then
change H/D.
Select Auto again for the next determination.
NOTE!
NOTICE!
If the "Auto" button is pressed to exit Auto Mode, the generator automat-
ically switches over to mAs mode and 100 mAs.
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Operation
NOTE!
NOTICE!
The kV and Anode/Filter combination can easily be changed by the user,
see section Setting the Exposure Data. The kV-value should be set to val-
ues recommended by the film/screen manufacturer or to values pre-
ferred by customer.
Presettings
Pivoted Object-table Arm (MAMMOMAT 3000 Nova only)
Two object tables can be installed on the pivoted object-table arm. Normally the table
sizes 18x24 cm and 24x30 cm are used. The object-table arm is rotatable 0° to -180°
to allow easy and quick change-over between the installed object tables.
To release the object-table arm, pull the lever downwards and then move it towards
the stand. The lever is located under the object table.
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Operation
Object Table
Removal of Object Table
1. Move the lever to the upright position.
2. Pull the table out and lift it up.
MAM00908
Figure 23. Mounting the object table
WARNING!
Setting the object-table release lever to upright position unlocks the ob-
ject table, and the compression plate automatically moves upwards to
parking position. Therefore, be sure not to touch the release lever dur-
ing biopsy procedures. Should the release lever be touched by mistake
while biopsy is being performed, there is a risk of causing potentially
severe personal injury to the patient.
Compression Plate
Removal of Compression Plate
Push the release button and pull the compression plate out from the compression
unit.
Compression plate
release button
MAM00675
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Operation
Film Marking
Slide the label corresponding to the projection used into the beam path.
R-mlo
MAM00907
Film Cassette
Insertion of Film Cassette
Slide the film cassette into position in the object table.
MAM00902
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Operation
Height Adjustment
The swivel-arm system is set to desired height by means of the vertical drive buttons
on either side of the tube head, on the remote control (option for MAMMOMAT 1000)
and on the supporting arm for the swivel-arm system. When the height adjustment
shall be set with the remote control (option for MAMMOMAT 1000), turn it towards
the tube head or keep it in the parking position.
M A M M O M AT 1000
MAM00676
Figure 28. Height adjustment buttons (MAMMOMAT 1000)
M A M M O M AT 1000
MAM00910
MAM00678
Figure 30. Height adjustment buttons (MAMMOMAT 3000 Nova)
WARNING!
There is a possible squeezing hazard during motorized movements.
Keep special attention when using the remote control (option for
MAMMOMAT 1000). Be aware of the jam risk that can occur in the
working area of MAMMOMAT 1000/3000 Nova.
NOTE!
NOTICE!
Avoid to expose the remote control (option for MAMMOMAT 1000) and
IR-detectors to bright light.
Do not use other remote controls in the working area of
MAMMOMAT 1000 with remote control (option) because interference
can occur.
38 Operator Manual
SPB7-230.201.08.06.02
Operation
MAM00909
Position markings Position markings on
compression plate
WARNING!
There is a possible pinching hazard between the AEC positioning lever
and the object table. The hazard exists if the lever is moved towards
the chest-wall position when the patient’s arm is resting on the side of
the object table.
Projection Angle
The swivel-arm system is rotatable between +135° clockwise and -180° counterclock-
wise. The rotary motion is motorized and controlled by buttons located on either side
of the tube head, on the remote control (option for MAMMOMAT 1000) and on the
supporting arm for the swivel-arm system.
Desired oblique projection angle can be preset by means of the projection angle pre-
setting knob at the back of the tube head. The preset angle is displayed for approx.
3 s, after which the actual angle is displayed again.
The rotary motion of the swivel-arm system stops automatically at 0° and at the pre-
set angle (+ and -), provided the movement to be performed extends over at least 14°.
If necessary, the projection angle can be fine-adjusted by actuating the rotary motion
buttons again for desired adjustment. Thus, the presetting knob need not be readjust-
ed.
The angle of the swivel-arm system is shown on the display on the stand.
The rotation and also the height adjustment are always locked when a compression
force of 3 kg (7 lbs) or more is displayed.
Projection angel
presetting knob
M A M M O M AT 1000
MAM00679
Figure 32. Buttons for rotation of the swivel-arm system (MAMMOMAT 1000)
40 Operator Manual
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Operation
Projection angel
presetting knob
M A M M O M AT 1000
MAM00905
Figure 33. Buttons for rotation of the swivel-arm system (MAMMOMAT 1000
with remote control (option))
Projection angel
presetting knob
MAM00681
WARNING!
There is a possible squeezing hazard during motorized movements.
Keep special attention when using the remote control (option for
MAMMOMAT 1000). Be aware of the jam risk that can occur in the
working area of MAMMOMAT 1000/3000 Nova.
NOTE!
NOTICE!
When the swivel-arm system is rotated W92° and height adjustment is
being performed, a safety system prevents the tube head from coming
closer to the floor than 120 mm. This is to prevent the patient's feet from
getting squeezed between the tube head and the floor. If the distance is
less than 120 mm, an error has occurred. All movements will be blocked.
Call service.
Face Shield
A face shield is provided to prevent the patient's head from coming into the beam
path. Attach the face shield by sliding it onto the holder. To remove the face shield,
bend the sides slightly outwards and slide it off the holder.
The face shield is available in two lengths.
MAM00682
Figure 35. Face shield
Field Light
The field light is automatically switched on by actuating the compression foot switch,
or by pressing the field-light button on the tube head or on the remote control (option
for MAMMOMAT 1000).
It is automatically switched off after a period of time (set at the installation of the
equipment, normally 30 s), at exposure (if exposure takes place before the preset
time has run out), or when the object-table arm is rotated to change over from one
object-table size to another, thus causing change of internal diaphragm.
M A M M O M AT 1000
MAM00683
42 Operator Manual
SPB7-230.201.08.06.02
Operation
M A M M O M AT 1000
MAM00906
Figure 37. Field-light switch (MAMMOMAT 1000 with remote control (option))
MAM00685
Motorized Compression
Compression can be applied by motor. The compression plate is moved up or down
by pressing the corresponding foot switch.
MAM00045
Figure 39. Foot switches
The compression speed will automatically decrease when the compression plate
comes in contact with the breast and the compression force is more than 1 kg (2 lbs).
The compression force applied by motor can be preset to a value from 3 kg (7 lbs) to
20 kg (44 lbs). This value is set with the knob on the compression unit. If more com-
pression force is required, the knobs for manual compression must be used.
If the measured compression force exceeds 20 kg (44 lbs), this is indicated on the
stand display by flashing dashes.
NOTE!
NOTICE!
Always make sure to position the foot switches so that they cannot be
unintentionally actuated by either the patient or the operator.
44 Operator Manual
SPB7-230.201.08.06.02
Operation
Step-by-step Procedure
1. Set the object table at proper height and projection angle for each patient.
2. Position the breast on the object table and lower the compression plate to the
breast.
3. Precompress the breast to 2 – 4 kg. It is recommended that this precompres-
sion be carried out gradually by applying “pumping” technique on the foot
switch, in order to maintain correct positioning of the breast and to avoid skin
folds.
4. Perform optimized compression by pressing the foot switch again and keeping
it steadily pressed, until OPCOMP interrupts the compression and the green in-
dicator lamp (OC) on the stand display is lit, see section Stand Display.
Do not use pumping technique to perform optimized compression.
Manual Compression
The compression plate can also be moved up or down by turning either of the knobs
on the sides of the compression unit.
MAM00664
Figure 40. Compression unit
Automatic Decompression
Automatic decompression is activated/deactivated with the con-
trol button on the control panel.
0/1
NOTE!
NOTICE!
In case of power failure, decompression must be carried out manually.
WARNING!
The automatic decompression must be deactivated, when the Biopsy
Compression Plate (hole plate) is used.
46 Operator Manual
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Operation
Error Indication
Operator errors are indicated by indicator lamps on the control panel. The indicator
lamps are described under Design and Function.
A malfunction detected by the system is indicated by “ER” followed by a three-digit
error code on the kV and the mAs displays on the control panel. This can be acknowl-
edged by the operator by pressing the limit button.
Limit errors are also cleared with the limit button.
If the error code remains after acknowledgement, or if the malfunction occurs fre-
quently, call service.
Temperature Monitoring
If the limit-button lamp flashes, this is an indication of that the tube temperature is
above normal. It is still possible to make exposures, however.
Should the temperature rise too high, error code “ER 802" will appear on the control
panel. Exposure release is now blocked.
Wait for the X-ray tube to cool down and then press the limit button. Should the error
code remain, the temperature is still too high. Wait another few minutes and press
the limit button again. When the error code disappears after acknowledgement, the
X-ray tube is ready for exposure again.
Shutdown
System Off
Press button “ “ on the control panel to turn the system off.
NOTE!
NOTICE!
The generator remains partly energized after the system has been
turned off.
Mo Mo W
kV mAs AEC Mo Rh Rh Program Auto Lim.
WARNING
MAM00048
Figure 41. Control panel, system OFF
Emergency Stop
If an emergency situation occurs, press the red button marked “STOP” on the back
of the tube head. This will stop all motorized movements of the equipment, see fur-
ther Emergency Shutdown Switch and Emergency Stop Button under Protective
Measures.
An error message will be displayed on the control panel after a short delay.
ST
OP
STOP
STOP
MAM00696
48 Operator Manual
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Operation
Special Cases
Spot compression (Option)
Spot compression is used to better visualize a special area of the breast. It gives a
clearer view of a small section of the breast. An external diaphragm is used to reduce
scatter and to improve image contrast.
MAM00050
Figure 43. Compression spoon
Attach the external diaphragm for special examinations (spot compression etc.) to the
holder on the underside of the tube head. The diaphragm is held in position by mag-
nets. For MAMMOMAT 1000 with Mo/Mo filter an external diaphragm is used for the
18x24 cm table and the magnification table and for spot mode, remove the external
diaphragm and change to external spot diaphragm.
Magnification (Option)
A magnification table with a magnification factor of 1.8 or 1.5 is used. When the mag-
nification table is mounted, the system automatically responds by setting the magni-
fication technique, i.e. microfocus and 18x24 cm diaphragm are selected.
(MAMMOMAT 1000 with single filter requires an external diaphragm.)
MAM00687
Figure 45. Magnification table
50 Operator Manual
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Operation
SHADOW CROSS
SS
RO
WC
DO
HA S External diaphragm
Shadow-cross unit
A
8
B
7
C
6
D
5
E
4
3
2
1
A
B
C
D
E
Compression plates
Prior to each use, examine compression plates for excessive wear, particularly near
the chest wall. Do not use the compression plate if it is damaged.
Replace the compression plate when cracks or excessive wear are evident to ensure
proper functioning and to minimize possible risks to the patient.
Insert a cassette and check that the lamp goes out. Take the
MAM00284
cassette out and check that the lamp is lit. This lamp also lights
up immediately after an exposure to prevent two exposures on
the same film cassette. It is possible to disable this function via
the service PC. If disabled, this check shall be disregarded.
Remove and reinstall the object table and check that the error
indication lamp goes on and off respectively.
MAM00285
• Check the motorized movements for smooth running and normal function.
• Check that the height adjustment and rotation of the swivel-arm system are
blocked, when the displayed compression force is ≥ 3 kg (7 lbs).
• Check the function of the Automatic Exposure Control (AEC) by making an
exposure of a phantom and checking the density of the film, after having per-
formed film processing quality control tests and checking that film process-
ing parameters are within control limits. Allow a system warm-up time of
approx. 5 minutes.
During Examination
• The radiation indicator lamp may light only when the exposure-release but-
tons are operated.
• Observe radiation protective measures.
52 Operator Manual
SPB7-230.201.08.06.02
Function and Safety Check
Weekly Checks
• Install the 18x24 cm table and turn on the field light. Check that the light field
is approximately 18x24 cm and inside the borders of the table.
• Install the 24x30 table and turn on the field light. Check that the light field is
approximately 24x30 cm and inside the borders of the table. By MAMMO-
MAT 1000 with single filter the external collimator plate 18x24 must be
mounted for the 18x24 cm. Proceed like above.
Monthly Checks
• Check the emergency stop button for proper function. With the button de-
pressed, all motorized movements shall be blocked.
• Check the self-braking of the compression motor. Run the compression plate
against the object table, until the compression force applied is 15 kg (33 lbs).
After one minute, the value shall not have changed by more than 2 kg (4 lbs).
Annual Maintenance
To maintain the safety and reliability of the unit, maintenance must be performed ev-
ery 12 months. Should you not have concluded a maintenance contract, please advise
the SIEMENS customer service department. See also section Safety.
In case of malfunctions, turn off the power supply to the system and notify the
customer service department.
Protective Measures
Emergency Shutdown Switch
If an emergency shutdown switch is installed in the room, the following must be not-
ed:
• The emergency shutdown switch must be operated at once if there is a haz-
ard for the patient, the operators, or the equipment. Operation of the switch
immediately cuts off the power and terminates all unit movements.
• The switch may be released and the system put into operation again only if
the cause of danger has been clearly recognized and eliminated. In all other
cases, for example, if the equipment malfunctions, Siemens' customer ser-
vice must be notified.
Explosion Protection
This product is not designed for operation in areas where there is an explosion hazard.
54 Operator Manual
SPB7-230.201.08.06.02
Protective Measures
Radiation Protection
m
1
Patient
Low radiation area
45
Radiation
protection
shield
Protected area
Staff Safety
Although the MAMMOMAT complies with the manufacturing standards for medical
X-ray equipment, radiation protection is largely dependent on the behavior of the op-
erating personnel.
The following regulations should therefore be observed:
1. During exposure, the operator shall stand behind the radiation protection shield.
If exposure is to be released via a separate wallmounted or tablemounted con-
trol console, or via an exposure handle on extension cord (optional), adequate
radiation protection in form of additional radiation shields or radiation-proof win-
dow in adjacent room must be provided.
2. If the radiation protection shield is not used, the operator shall wear protective
clothing of 0.25 mm lead equivalent or stand in the low radiation area behind the
patient, at a distance of at least 1 m from the object under examination.
3. Wear a film badge or pen dosimeter for monitoring of the personal radiation ex-
posure.
Patient Safety
Before exposure is released, it is the operator's duty to check that the exposure pa-
rameters set on the control panel are the ones intended and that they have not
changed, while attending to the patient. Failure to do so might expose the patient to
unnecessary radiation.
The object table and the base plate together function as a beam stopper.
The face shield prevents the patient's head from coming into the beam path.
Face shield
Beam path
MAM00688
Figure 49. Beam path
56 Operator Manual
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Protective Measures
Mechanical Safety
Hazard Areas
In proper operation of the equipment and when positioning the patient, the operator
and the patient may only hold onto the handles provide for this purpose.
It is the operator's duty to ensure that any danger to the patient or third parties is pre-
cluded, before movements are released.
Possible hazard areas are indicated in the figure below.
Hazard areas
for patient
M A M M O M AT 1000
Stand with fixed object-table arm (MAMMOMAT 3000 Nova) Stand with fixed object-table arm (MAMMOMAT 1000)
MAM00689
Risk of Stumbling
The operating personnel should be aware of that the protruding feet of the free-stand-
ing radiation shield and the base plate of the generator with integrated radiation shield
might pose a risk of stumbling. Possible hazard areas are indicated in the figure below.
58 Operator Manual
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Protective Measures
Waste Disposal
Public legal directives can contain special regulations regarding disposal of this prod-
uct. To avoid environmental pollution and human injury, we therefore request that you
contact us if you wish to cease operation of this product with the intention of dispos-
ing of it.
Other Metal
• In the X-ray tube Beryllium, approximately 0.7 g
Nickel, approximately 50 g
Molybdenum/Tungsten, approximately 560 g
Plastic Material
• Epoxy resin on the circuit boards, approximately 1.5 kg
• Insulating material, PVC, from the cables, approximately 6 kg
• Surface coating, PVC, on the stand covers, approximately 0.6 kg
• Tube-head covers, PUR, approximately 3.5 kg
Electrolytic Capacitors
• Capacitors in electronics on the circuit boards, approximately 2 kg
Mechanical Hazard
Please contact your Siemens customer service.
• The tension in the counter-balance spring
• Metal curtain (sharp edges)
Options
Stereotactic Biopsy Unit (MAMMOMAT 3000 Nova only)
• Lead in solderings on the circuit boards, approximately 0.1 kg
• Epoxy resin on the circuit boards, approximately 0.2 kg
• Insulating material, PVC, from the cables, approximately 0.9 kg
60 Operator Manual
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Identification Labels
Identification Labels
Stand
SIEMENS
Röhre/Tube P 40 MoW
MODEL-NO.
SERIAL-NO. S20
MAMMOMAT 3000 This product complies with DHHS regulations MADE IN GERMANY
21 CFR Subchapter J. applicable at date of
manufacture. This product complies with DHHS regulations
Manufactured: 21 CFR Subchapter J. applicable at date of
Siemens Aktiengesellschaft manufacture.
Wittersbacherplatz 2, D - 80333 München Manufactured:
Germany Siemens Aktiengesellschaft
Wittersbacherplatz 2, D - 80333 München
Germany
SIEMENS
P 40 MoW-100g
MODEL-NO.
SERIAL-NO. S20 L
SIEMENS
Sy stem
(S) Serial No. 10 01 20 04 IVK
Siemens Aktiengesellschaft, Wi ttelsbacherplat z 2 , DE-80333 Muenchen
Made in Germany
X-Ray Equipment
R
IVK
(S) Serial No.
Made in Sweden
X-ray Equipment
Classified by
Momentary 10 kVA
Long-time 0.8 kVA
MAM00943
for USA
Identification Labels
X-Ray Equipment
(1P) Model No. 01234567
0123 R
Rev. 00 01 02 03 04 05 06 07 08 09 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24
This product complies with DHHS regulations This product complies with DHHS regulations
21 CFR Subchapter J. applicable at date of 21 CFR Subchapter J. applicable at date of
manufacture. manufacture.
Manufactured: Manufactured:
Siemens Aktiengesellschaft Siemens Aktiengesellschaft
Wittersbacherplatz 2, D - 80333 München Wittersbacherplatz 2, D - 80333 München
MAM00944
Germany Germany
SPB7-230.201.08.06.02
Operator Manual
SPB7-230.201.08.06.02
Rev. 00 01 02 03 04 05 06 07 08 09 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24
This product complies with DHHS regulations
21 CFR Subchapter J. applicable at date of
manufacture.
Manufactured:
Siemens Aktiengesellschaft
for USA
MAM00945
63
Identification Labels
Cleaning, Disinfection
Cleaning, Disinfection
The unit must be switched off and disconnected from the power supply before it is
cleaned or disinfected, however when cleaning the parts which come into contact
with the patients during each exam, it is not necessary to turn off the system. These
parts are compression plates, object table, patient handles and face shield.
Cleaning
All parts of the unit which come in contact with the patient must be cleaned prior to
each examination.
Wipe the unit with a wet cloth or cotton pad. For moistening, use water or lukewarm,
diluted aqeous solution of household dishwashing liquid.
Do not use abrasive cleansers and organic solvents (because of incompatibility of ma-
terial) or cleaning agents containing solvents (e.g. benzine, stain remover)!
CAUTION!
Do not spray the unit! The cleaning fluid must under no circumstances
penetrate into the unit.
64 Operator Manual
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Cleaning, Disinfection
Disinfection
For surface disinfection, we recommend the use of isopropyl alcohol. Disinfectants
based on substituted phenols and compounds splitting of chlorine are somewhat
caustic and therefore, cannot be generally recommended.
As a general rule, no disinfectant sprays may be used, since the spray mist may pen-
etrate into the unit, which means that the safety of the unit can no longer be assured
(damage to electronic components, formation of inflammable air/solvent fumes mix-
tures).
WARNING!
As is known, some components of disinfectants are detrimental to
health. Their concentration in breathable air must not exceed a legally
determined limit. We recommend that the appropriate directions on
use issued by the manufacturers of these agents be strictly observed.
CAUTION!
Substances, such as anaesthetics and skin disinfectants, used during bi-
opsies can damage or discolour the plastic part of the compression
plates. Immediately wipe off with a wet cloth any of these substances
spilled on the compression plates.
Technical Specifications
Tube rating charts
Anode Heating Curves and Cooling curve
P 40 Mo W
66 Operator Manual
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Technical Specifications
Figure 56. X-ray tube heating curves and cooling curve with fan
Technical Data
The equipment shall be used in rooms intended for medical purposes.
The national regulations in effect apply primarily. However, we strongly recommend
adherence to the standards described herein - provided they do not contradict national
regulations in effect - to ensure the safety of operators, patients, and third parties.
Power Supply
Generator
Radiation Shield
68 Operator Manual
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Technical Specifications
X-ray tube (Mo alt. Mo/W) P40 Mo/W. Molybdenum alt. molybdenum/tung-
sten rotating anode tube with beryllium window.
Two alt. four focal spots with nominal values 0.3
and 0.15 (IEC); 0.3 and 0.1 (star pattern).
Tube current (Mo and Mo/W) Molybdenum focal spot track maximum current;
Large focal spot: 150 mA at 25 kV
Small focal spot: 28 mA at 25 kV
MAMMOMAT 3000 Nova only Tungsten focal spot track maximum current;
Large focal spot: 188 mA at 25 kV
Small focal spot: 34 mA at 25 kV
Nominal tube voltage 35 kV, maximum 134 mA
Anode - filter combination Mo tube: Mo/30 µm Mo
Mo/25 µm Rh
MAMMOMAT 3000 Nova only Mo/W tube: Mo/30 µm Mo
Mo/25 µm Rh
W/50 µm Rh
MAMMOMAT 1000 with single Mo tube: Mo/30 µm Mo
filter
Source to image receptor 650 mm (fixed)
distance (SID)
Max. width radiation-field 308 mm + 4 mm = 312 mm
Max. depth radiation-field 240 mm + 17 mm = 257 mm
Molybde- Tungsten-
num alloy Rhenium
Nominal focal spot value at 27 kV* 0.15 0.3 0.15 0.3
with star pattern (IEC 336) 0.1 0.1
Nominal power thermal anode 0.7 kW 3.75 kW 0.85 kW 4.7 kW
reference power = 150 W (IEC 613)
Cathode filament heating ~/AC, < 25 kHz
Max. current 7.9 A 7.5 A 7.9 A 7.5 A
Max. voltage ≈3V ≈ 5.5 V ≈3V ≈ 5.5 V
Optical anode angle (IEC 788) 20°
Anode material Molybdenum alloy ,Tungsten-Rhenium
Outer layer material Molybdenum alloy Tungsten-Rhenium
Anode heat storage capacity (IEC 613)120000 J (162000 HU)
Max. dissipation rate of the anode 30000 J/min (40500 HU/min)
Anode drive 160 Hz (≈ 8800 min-1)
Radiography
Starter systems
MAMMOMAT 3000
Tube assembly heat-storage 1100000 J
capacity see also
"Heating and cooling curves"
(IEC 613)
Max. continuous heat dissipation of Ambient temperature 20 - 25° C (40° C)
the tube assembly with fan 300 W (200 W)
(IEC 613)
Leakage radiation (at 50 kW/300 W < 0.7 mGy/h
at a distance of 1 m (IEC 601-1-3)
Total filtration of tube assembly 1 mm Be (≈ 0.02 mm Al)
(Al equivalent)
Additional filters are on the unit
(IEC 522)
Temperature for transport and - 20° C ... + 70° C
storage
Weight ≈ 17 kg
High-voltage connection 3-pole
70 Operator Manual
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Technical Specifications
Electrical Data
The Dose Exchange values and the HVL values can be measured by the hospital’s
medical physicist, by following the instructions in the document “Radiographic Hand-
book, Dose Calculation System”.
NOTE!
NOTICE!
Users should be aware of that the dose value displayed is an estimated
value and the accuracy of all parameters in the calculation affects the ac-
curacy of displayed value.
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Technical Specifications
Classifications
* The leakage radiation of the tube housing assembly and attached collimator complies with the
requirements of 21 CFR, part 1020.30(k).
Environmental conditions
(according to IEC/EN 60601-1)
Operation
Stand
650
+135˚
-180
2120
2033
650-1350
866
537
520
1091
MAM00691
640
74 Operator Manual
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Technical Specifications
Generator
885.5
1960
MAM00719
700 340
708 540
Figure 58. Generator with integrated control panel and radiation shield
MAM00723
530 290
330
Weight 130 kg
782 450
Mo Mo W
kV mAs AEC Mo Rh Rh Program Auto Lim.
WARNING
MAM00069
76 Operator Manual
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Technical Specifications
CAUTION!
The use of accessories, transducers and cables other than those speci-
fied, with the exception of transducers and cables sold by the manufac-
turer of the equipment or system as replacement parts for internal
components, may result in increased emission or decreased immunity of
the equipment or system.
RF emissions Group 1 The system uses RF energy only for its internal func-
CISPR 11 tion. Therefore, its RF emissions are very low and are
not likely to cause any interference in nearby elec-
tronic equipment
Emission of voltage Not applicable The system has a nominal input current of more than
fluctuations/flicker 16 A per phase.
IEC 61000-3-3
CAUTION!
The equipment or system should not be used adjacent to or stacked with
other equipment. If adjacent or stacked use is necessary, the equipment
or system should be observed to verify normal operation in the configu-
ration in which it will be used.
78 Operator Manual
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Technical Specifications
Voltage dips, short inter- < 5% UT Not applicable Mains power quality should be that of a typi-
ruptions and voltage vari- (> 95% dip in UT) cal commercial or hospital environment. If the
ations on power supply for 0.5 cycles user of the system requires continued opera-
input lines < 40% UT tion during power mains interruptions, it is
IEC 61000-4-11 (> 60% dip in UT) recommended that the system be powered
for 5 cycles from an uninterruptible power supply.
< 70% UT The system has a nominal input current of
(> 30% dip in UT) more than 16 A per phase.
for 25 cycles
< 5% UT < 5% UT
(> 95% dip in UT) (> 95% dip in UT)
for 5 sec for 5 sec
NOTE: UT is the a.c. mains voltage prior to application of the test levels.
Immunity test IEC 60601 test level Compli- Electromagnetic environment - guidelines
ance
level
Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.
a
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 system is used
exceeds the applicable RF compliance level above, the system should be observed to verify normal operation.
If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocat-
ing the system.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
80 Operator Manual
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Technical Specifications
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in
meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the max-
imum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
82 Operator Manual
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Technical Specifications
NOTE!
NOTICE!
Whoever attaches an accessory to a medical device is considered to
modify the system and must assure that the configuration meets rele-
vant standards (e.g IEC/60601-1-1 or/and other applicable regulations). In
case of questions please contact your local Siemens contact.
84 Operator Manual
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© Siemens AG 2006
All rights reserved
Contact address: