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Operator Manual

MAMMOMAT 1000/3000 Nova


Laws and regulations:
The installer and operator are responsible for complying with all local regulations
regarding the installation and the operation of the system.
In all countries, the legally established regulations are to be observed. Values oth-
er than those indicated in these operating instructions may be programmed
where required by local country-specific regulations.
This product is identified by the CE mark in compliance with the provisions of the
Council Directive 93/42//EWG of June 14th 1993 concerning medical devices.
Person-specific data is subject to data protection. Ensure compliance with all ap-
plicable laws and regulations.
All legally required tests must be performed at the prescribed time intervals:
Eg. Constancy test according to the X-ray ordinance (§ 16 RöV) in the Federal Re-
public of Germany.
Tests based on DHHS guidelines (Department of Health and Human Services).
Mammomat 1000/3000 Nova complies with the applicable standards of
IEC 60601 series.

The original version of this manual was written in English language.


Contents

Introduction
Important Note . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Range of Application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Design and Function


Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6
Stand . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6
MAMMOMAT 1000 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6
MAMMOMAT 3000 Nova . . . . . . . . . . . . . . . . . . . . . . . . . . .7
Generator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8
Separate Control Console (option) . . . . . . . . . . . . . . . . . . . . . . . . . .9
Free-standing Radiation Shield (option) . . . . . . . . . . . . . . . . . . . . . . 10
Control Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Control Buttons and Indicators . . . . . . . . . . . . . . . . . . . . . . . 12
Error Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Dose Calculation (option) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Stand Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6
Swivel-arm system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
MAMMOMAT 1000 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
MAMMOMAT 1000 with remote control (option) . . . . . . . . . . . . . . 18
MAMMOMAT 3000 Nova . . . . . . . . . . . . . . . . . . . . . . . . . . 19
X-ray Tube . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
MAMMOMAT 1000 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
MAMMOMAT 3000 Nova . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Collimator Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Single Filter Collimator Unit . . . . . . . . . . . . . . . . . . . . . . . . . 20
Filter disc . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Mirror . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Field Light . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
External Diaphragms . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Pivoted Object-table Arm (MAMMOMAT 3000 Nova only) . . . . . . . . . . . . 21
Object Tables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Base Plate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Film Marking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Compression . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3
Foot Switches . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Manual Compression/Decompression . . . . . . . . . . . . . . . . . . . 23
Automatic Decompression . . . . . . . . . . . . . . . . . . . . . . . . . 24
Decompression Button on Separate Control Console . . . . . . . . . . . . 24
Compression Plates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

Safety
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Checks, Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Installation, Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Warning Note . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

MAMMOMAT 1000/3000 Nova 1


SPB7-230.201.08.06.02
Contents

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
SPB7-230.201.08.06.02
Contents

Function and Safety Check


Daily Checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
Before Examination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
During Examination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
Weekly Checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Monthly Checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Annual Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53

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

MAMMOMAT 1000/3000 Nova 3


SPB7-230.201.08.06.02
Contents

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
SPB7-230.201.08.06.02
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

Figure 1. MAMMOMAT 1000/3000 Nova

MAMMOMAT 1000/3000 Nova 5


SPB7-230.201.08.06.02
Design and Function

Design and Function


Overview
The modular MAMMOMAT 1000/3000 Nova system comprises:
• Free-standing X-ray stand with swivel-arm system consisting of X-ray tube
assembly and image receptor assemblies.
• Free-standing generator with integrated control panel and radiation shield.
The control panel and the radiation shield can be separated from the gener-
ator, see further sections Generator, Separate Control Console (option) and
Free-standing Radiation Shield (option) on the following pages.

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

Remote control (option)

Fixed object-table arm Fixed object-table arm


with one object table with one object table
MAM00668
MAM00665

Figure 2. Stand with fixed object-table arm

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.

6 Operator Manual
SPB7-230.201.08.06.02
Design and Function

MAMMOMAT 3000 Nova


The X-ray stand is available in four versions:
• Stand with fixed object-table arm for one object table (18x24 cm or
24x30 cm) and Mo X-ray tube (molybdenum rotating anode tube).
• Same as above, but with Mo/W X-ray tube (molybdenum/tungsten rotating
anode tube).
• Stand with pivoted object-table arm for two different object tables (18x24 cm
and 24x30 cm) and Mo X-ray tube.
• Same as above, but with Mo/W X-ray tube.

Counterweight

Fixed object-table arm Pivoted object-table


with one object table arm with two object
tables

MAM00669

Figure 4. Stand with fixed object-table arm Figure 5. Stand with pivoted object-table arm

MAMMOMAT 1000/3000 Nova 7


SPB7-230.201.08.06.02
Design and Function

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

Figure 7. Separate generator

8 Operator Manual
SPB7-230.201.08.06.02
Design and Function

Separate Control Console (option)


The generator control panel is available in a separate control console for installation in
a suitable place, either in the examination room or in an adjacent room with radiation-
proof window.
The control console can be wall-mounted – vertically or horizontally – or be mounted
on a table. It is also possible to mount the control console on the optional free-stand-
ing radiation shield.

Mo Mo W
kV mAs AEC Mo Rh Rh Program Auto Lim.
WARNING

Control console horizontally wall-mounted

Control console vertically wall-mounted

Control console mounted on the


free-standing radiation shield

Figure 8. Control console

MAMMOMAT 1000/3000 Nova 9


SPB7-230.201.08.06.02
Design and Function

Free-standing Radiation Shield (option)


The free-standing radiation shield can be installed in any suitable place in the exami-
nation room.

Figure 9. Free-standing radiation shield

10 Operator Manual
SPB7-230.201.08.06.02
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

Figure 10. Control panel integrated in the generator

Mo Mo W
kV mAs AEC Mo Rh Rh Program Auto Lim.
WARNING

Decompression button

Figure 11. Control panel in separate control console

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.

MAMMOMAT 1000/3000 Nova 11


SPB7-230.201.08.06.02
Design and Function

Control Buttons and Indicators

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:

System ON/OFF buttons

mAs +/- mAs selection and display.


In AEC mode (Automatic Exposure Control), the display
remains dark before exposure. After exposure, the mAs value reached
during radiography is indicated.

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.

kV +/- kV selection and display.


If the dose calculation option is enabled (refer to page 15), the kV
display shows the kV value at the same time as the mAs value is
shown on the mAs/mGy display. When the dose value is shown on
the mAs/mGy display, the kV display shows “---”.

+/- film density adjustment and display.


The display shows values between -24 and +24 (± 3 exposure points).
One step is equal to 1/8 exposure point, corresponding to a 3% differ-
ence in mAs (approximately 0.05 OD).

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
SPB7-230.201.08.06.02
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.

ON/OFF button to select/deselect automatic decompression after expo-


sure. When OFF, use the foot switch for motorized decompression or the
knobs for manual decompression.
0/1

Limit button (acknowledgment). Serves to reset the system after errors,


Lim.
indicated by an error code, or after faulty exposures, indicated also by an
acoustic signal and limit lamp being lit (e.g. limit mAs, dose monitoring,
interrupted exposure). Flashing limit lamp indicates that the tube tempera-
>0<
ture is above normal.

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.

Decompression button (only with the separate control console) to be used


in case of release needed before exposure. The button must be kept
pressed until the breast is decompressed.

Option
Exposure release handle on extension cord is available for the separate con-
trol console.

MAMMOMAT 1000/3000 Nova 13


SPB7-230.201.08.06.02
Design and Function

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.

A) Object table is not locked in position.


B) Pivoted object-table arm is not in position (only on fully extend-
ed version).

Risk of collision between X-ray tube assembly and floor (limit


switch is actuated). In stereotactic mode: X-ray tube assembly is
not in 0° or ±10° position. The stereotactic mode is available for
MAMMOMAT 3000 Nova only.

AEC detector is not in chest-wall position (only in stereotactic


MAM00287

mode). The stereotactic mode is available for


MAMMOMAT 3000 Nova only.

Diaphragm is not in correct position. In stereotactic mode: External


diaphragm is not in position. The stereotactic mode is available for
MAMMOMAT 3000 Nova only. (MAMMOMAT 1000 with single
filter: External diaphragm is not in position when using 18x24 cm
or magnification object tables.)

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.

Yellow light and an acoustic signal indicate radiation ON.

14 Operator Manual
SPB7-230.201.08.06.02
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).

Dose Calculation (option)


With the Dose Calculation option the absorbed glandular dose is estimated and can be
displayed on the control panel and shown on print. The dose value is a theoretically
calculated value based on exposure and source table data. Some data can be
measured by the hospital’s medical physicist, see Calculated absorbed glandular dose
(page 72).
The Dose Calculation option must be enabled / disabled by a service technician.
Disabling the dose calculation option prevents dose values from being displayed on
the control panel. If the printer option is installed, and configured to show dose values,
they will still show on print.
Dose calculation is available in both Manual Mode and AEC Mode.

MAMMOMAT 1000/3000 Nova 15


SPB7-230.201.08.06.02
Design and Function

Stand Display
The stand display is placed down in the lower part of the stand.

mm
F o
OC

Figure 12. Stand display MAM00024

Compression force (F).


MAM00388

Before compression, the preset maximum compression force is


OC F
displayed, while during compression, the actual force is dis-
played.
OC (green light) indicates optimal compression reached, see
section Optimized Compression OPCOMP.

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.

Green lamp, indicates unit ready for exposure (same as on the


control panel).

16 Operator Manual
SPB7-230.201.08.06.02
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 Projection angle presetting knob 9 Face shield


2 Patient handle 10 Knob for manual compression/decompression
3 Emergency-stop button 11 Button for release of compression plate
4 Buttons for height adjustment and rotation of swivel- 12 Compression plate
arm system.
5 X-ray tube assembly with collimator 13 Object table
6 Field-light button 14 Base plate
7 Holder for external diaphragm, face shield and 15 Lever for positioning the AEC detector
shadow cross
8 Maximum compression force presetting knob 16 Patient handle

Figure 13. Swivel-arm system

MAMMOMAT 1000/3000 Nova 17


SPB7-230.201.08.06.02
Design and Function

MAMMOMAT 1000 with remote control (option)

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

1 Projection angle presetting knob 10 Knob for manual compression/decompression


2 Patient handle 11 Button for release of compression plate
3 Emergency-stop button 12 Compression plate
4 Buttons for height adjustment and rotation of swivel- 13 Object table
arm system.
5 X-ray tube assembly with collimator 14 Base plate
6 Field-light button 15 Lever for positioning the AEC detector
7 Holder for external diaphragm, face shield and 16 Patient handle
shadow cross
8 Maximum compression force presetting knob 17 Infrared detector for remote control
9 Face shield

Figure 14. Swivel-arm system

18 Operator Manual
SPB7-230.201.08.06.02
Design and Function

MAMMOMAT 3000 Nova

11
1
8
2 12
3 13
4 14
5 15
6 16
7 17
8 18
2
19
9

MAM00672
20
10

1 Projection angle presetting knob 11 X-ray tube assembly with collimator


2 Object table 12 Field-light button
3 Patient handle 13 Holder for external diaphragm, face shield and
shadow cross
4 Emergency-stop button. 14 Maximum compression force presetting knob
5 Lever for releasing/locking the object table 15 Face shield
6 Pivoted object-table arm 16 Knob for manual compression/decompression
7 Patient handle 17 Button for release of compression plate
8 Buttons for height adjustment and rotation of swivel- 18 Compression plate
arm system.
9 Lever for switching between normal mode and ster- 19 Base plate
eotactic mode
10 Lever for release of object-table arm rotation 20 Lever for positioning the AEC detector

Figure 15. Swivel-arm system

MAMMOMAT 1000/3000 Nova 19


SPB7-230.201.08.06.02
Design and Function

X-ray Tube
MAMMOMAT 1000
The MAMMOMAT 1000 system can only use the Mo tube with molybdenum rotating
anode and two focal spots.

MAMMOMAT 3000 Nova


Two types of X-ray tubes can be used in the MAMMOMAT 3000 Nova system – ei-
ther the Mo/W tube with molybdenum/tungsten rotating anode and four focal spots,
or 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)

Single Filter Collimator Unit


• fixed molybdenum filter
• mirror
• field-light bulb
• external diaphragms for 18x24 cm and magnification object tables

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.

20 Operator Manual
SPB7-230.201.08.06.02
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.

Pivoted Object-table Arm (MAMMOMAT 3000 Nova only)


The pivoted object-table arm allows quick and easy change-over between two differ-
ent object tables (18x24 cm and 24x30 cm).

MAM00673
Lever for release of
object-table arm

Figure 16. Object tables on pivoted 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.

MAMMOMAT 1000/3000 Nova 21


SPB7-230.201.08.06.02
Design and Function

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

Rcc = Right cranio-caudal


Rml = Right medio-lateral
Rmlo = Right medio-lateral oblique
Blank marking labels can be supplied on request (option). The customer can then, if
needed, engrave their own labels.

R-mlo

MAM00907

Figure 17. Film marking labels

22 Operator Manual
SPB7-230.201.08.06.02
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.

Knobs for manual


compression/decompression
MAM00664

Figure 19. Knobs for manual compression/decompression

MAMMOMAT 1000/3000 Nova 23


SPB7-230.201.08.06.02
Design and Function

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.

Decompression Button on Separate Control Console


For patient safety reasons, the separate control console is pro-
vided with an extra decompression button, which can be used in
case of emergency, especially when the control console is
installed in an adjacent room. The button must be kept pressed
until the breast is decompressed.

Compression Plates
A variety of compression plates are available.

NOTE!
NOTICE!
The compression plates are articles of consumption.
MAM00033

Figure 20. Low-edge compression plate for normal mammograms

NOTE!
NOTICE!
The compression automatically moves upwards, when the object-table
arm is rotated, or when the object table is unlocked.

24 Operator Manual
SPB7-230.201.08.06.02
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.

MAMMOMAT 1000/3000 Nova 25


SPB7-230.201.08.06.02
Safety

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
SPB7-230.201.08.06.02
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

The internal monitoring system automatically performs a functional check of the


equipment.
When the green lamps on the control panel and the stand display are lit, the equip-
ment is ready for exposure.
In the event of a malfunction, an error code will be presented on the kV and mAs dis-
plays on the control panel. This can be acknowledged by the operator by pressing the
limit button. Should the error code still remain after acknowledgement, call service.

MAMMOMAT 1000/3000 Nova 27


SPB7-230.201.08.06.02
Operation

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.

2. Select compression plate corresponding to examination and object table size.


3. Install the face shield, if needed.
4. Insert film marking labels.
5. Insert film cassette.
6. Adjust the swivel-arm system to desired projection angle.
7. Adjust the swivel-arm system to correct height.
8. Check that the green lamp on the control panel or on the stand display is lit.
9. Position the breast on the object table.
10. Use the compression foot switch to lower the compression plate. Compression
can be applied with the foot switch or by hand. The compression force and the
compressed thickness of the breast are shown on the stand display.
11. Make sure that the breast is properly compressed. Using the field light, check
that no skin folds have arisen in the course of compression. The nipple should
be in profile whenever possible.
12. Ensure that nothing else but the breast to be examined is within the radiation
field.
13. Set the exposure parameters on the control panel.
14. Make the exposure. Keep both exposure buttons pressed (button, if the option-
al exposure handle on extension cord is used), until the acoustic signal stops.
15. Make sure the breast is decompressed, automatically or manually, immediately
after exposure.
16. If the dose calculation option is enabled, read the calculated glandular dose on
the control panel. The value will be displayed until any button on the control
panel is pressed.

28 Operator Manual
SPB7-230.201.08.06.02
Operation

Setting the Exposure Data


Manual Mode (mAs mode)
• Set desired kV values with the kV buttons (the kV value appears on the dis-
play).
• Set desired mAs value with the mAs buttons (the mAs value appears on the
display).
• Select desired anode/filter combination.

AEC Mode (Automatic Exposure Control)


• Set desired kV value with the kV buttons.
• Activate AEC mode by pressing one of the two speed buttons (H for high
speed and D for detail screens).
• Select desired anode/filter combination.
To change over to mAs mode, press either the + or the - mAs button.

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.

MAMMOMAT 1000/3000 Nova 29


SPB7-230.201.08.06.02
Operation

Automatic Program Selection Mode OPDOSE


To select Auto Mode, press the "Auto" button. The indicator lamp lights up to indicate
Auto Mode selected.
In Auto Mode, the unit automatically suggests the appropriate program (kV, density,
anode/filter combination and H/D) to be used, based on individual breast thick-
ness.The new program recommended by the unit is indicated by flashing light, while
the program used for the previous exposure is indicated by fixed light. The operator
can now choose either to keep the current program by pressing the exposure-release
button or to follow the recommendation by pressing the button indicated by flashing
light. In the latter case, the flashing light turns into fixed light to indicate new program
selected, while the indicator lamp for the previous program goes out.
This verification by the operator is to avoid undesired changes in beam quality for one
and the same patient.
To exit Auto Mode, press either the "Auto" button or one of the program buttons, how-
ever, not a button indicated by flashing light.

NOTE!
NOTICE!
If the "Auto" button is pressed to exit Auto Mode, the generator automat-
ically switches over to mAs mode and 100 mAs.

Quick Guide for OPDOSE


1. Make sure that the Auto indicator is lit.
2. Position the patient and apply compression onto the breast. The compression
force must be at least 6 kg for the Opdose to activate.
3. Opdose will now suggest a program, based on the compressed thickness of the
breast. An indicator lamp will be flashing over the suggested program.
4. Inform the patient that there will be a noise from the X-ray tube and that she
shall feel at ease.
5. Confirm by pressing the program button for the suggested program.
6. Make the exposure.

30 Operator Manual
SPB7-230.201.08.06.02
Operation

Program Values as Preset from the Factory


With Mo X-ray Tube

Program Compressed kV value Anode/Filter


thickness combination
1 0 – 30 mm 26 Mo/Mo
2 31 – 45 mm 27 Mo/Mo
3 46 – 60 mm 27 Mo/Rh
4 ≥ 61 mm 28 Mo/Rh

MAMMOMAT 1000 with Single Filter

Program Compressed kV value Anode/Filter


thickness combination
1 0 – 30 mm 26 Mo/Mo
2 31 – 45 mm 27 Mo/Mo
3 46 – 60 mm 28 Mo/Mo
4 ≥ 61 mm 29 Mo/Mo

With Mo/W X-ray Tube

Program Compressed kV value Anode/Filter


thickness combination
1 0 – 30 mm 26 Mo/Mo
2 31 – 45 mm 27 Mo/Mo
3 46 – 60 mm 27 Mo/Rh
4 ≥ 61 mm 26 W/Rh

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.

MAMMOMAT 1000/3000 Nova 31


SPB7-230.201.08.06.02
Operation

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.

Lever to release the rotation


of the object-table arm
MAM00674

Figure 22. Pivoted object-table arm

The collimation is automatically changed to match the selected object table.

32 Operator Manual
SPB7-230.201.08.06.02
Operation

Object Table
Removal of Object Table
1. Move the lever to the upright position.
2. Pull the table out and lift it up.

Mounting the Object Table


1. Place the object table on the base plate and slide it into position.
2. Lower the lever to lock the table in position.

MAM00908
Figure 23. Mounting the object table

Hazard Note on Unintentional Decompression

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.

MAMMOMAT 1000/3000 Nova 33


SPB7-230.201.08.06.02
Operation

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

Figure 24. Removal of compression plate

Mounting the Compression Plate


Push the compression plate onto the pin of the compression unit.
The compression plate automatically locks in position.

34 Operator Manual
SPB7-230.201.08.06.02
Operation

Film Marking
Slide the label corresponding to the projection used into the beam path.

R-mlo

MAM00907

Figure 25. Film marking

Film Cassette
Insertion of Film Cassette
Slide the film cassette into position in the object table.
MAM00902

Figure 26. Insertion of film cassette

MAMMOMAT 1000/3000 Nova 35


SPB7-230.201.08.06.02
Operation

Removal of Film Cassette


1. Press and hold down the button on top of the object table (refer to Figure 27.)
2. On the side of the object table there is a lever that locks the cassette to the object
table. Move the lever to the side, the cassette is automatically ejected.
(refer to Figure 27.).
3. Remove the cassette.

Press and hold down the button

Move the lever

Figure 27. Removal of film cassette

36 Operator Manual
SPB7-230.201.08.06.02
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

Figure 29. Height adjustment buttons (MAMMOMAT 1000 with remote


control (option))

MAMMOMAT 1000/3000 Nova 37


SPB7-230.201.08.06.02
Operation

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

Positioning the AEC Detector


The AEC detector can be positioned anywhere between the end positions. The three
position markings on the side of the base plate correspond with the position markings
on the compression plate. Ensure that the breast completely covers the position of
the AEC detector. Do not forget to return the detector to the chestwall-close position
after each patient.

MAM00909
Position markings Position markings on
compression plate

Figure 31. Positioning the AEC detector

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.

MAMMOMAT 1000/3000 Nova 39


SPB7-230.201.08.06.02
Operation

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
SPB7-230.201.08.06.02
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

Figure 34. Buttons for rotation of the swivel-arm system


(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!
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.

MAMMOMAT 1000/3000 Nova 41


SPB7-230.201.08.06.02
Operation

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

Figure 36. Field-light switch (MAMMOMAT 1000)

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

Figure 38. Field-light switch (MAMMOMAT 3000 Nova)

MAMMOMAT 1000/3000 Nova 43


SPB7-230.201.08.06.02
Operation

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.

Optimized Compression OPCOMP


The automatic "optimized compression" system OPCOMP® determines the proper
amount of compression force to be applied on the breast, based on individual breast
characteristics, to achieve optimum patient comfort and image quality.

Guidance for Proper Use of OPCOMP


Correct positioning is a must for OPCOMP.

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.

Important Notes on OPCOMP


• It is very important that you have confidence in OPCOMP, when learning
how to use it. Properly used, OPCOMP will give you consistent and correct
compression, exam after exam.
• Some breasts might need 20 kg for correct compression. If this is more than
your clinic would allow, you can always set a maximum compression force
with the compression force presetting knob (placed high on the compression
unit, see Figure 40.).
• The optimized compression shall be regarded as a recommendation to the
operator. Additional force up to the preset value can be applied by just press-
ing the foot switch again. If the preset maximum compression force is less
than the “optimized compression” value, the preset maximum force applies.
• Patients with implants, or patients who recently have had breast surgery,
must not be exposed to optimized compression.
Use instead the foot switch in the normal way, or the knobs for manual com-
pression, to adjust proper compression force on the breast.
• Manual compression does not activate OPCOMP.
• Do not use OPCOMP when the flexible compression plates, spot compres-
sion plates, magnification table or biopsy compression plates are used.

MAMMOMAT 1000/3000 Nova 45


SPB7-230.201.08.06.02
Operation

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.

Maximum compression force


presetting knob

Knobs for manual


compression/decompression

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
SPB7-230.201.08.06.02
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.

MAMMOMAT 1000/3000 Nova 47


SPB7-230.201.08.06.02
Operation

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

Figure 42. Emergency stop button

48 Operator Manual
SPB7-230.201.08.06.02
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

Use the compression spoon and the appropriate diaphragm.

Attaching the External Diaphragm


MAM00686

Figure 44. Attaching the external diaphragm

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.

MAMMOMAT 1000/3000 Nova 49


SPB7-230.201.08.06.02
Operation

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

Mounting the Magnification Table


1. Move the locking lever to the upright position and remove the object table.
2. Place the magnification table on the base plate.
3. Slide the magnification table into position and lower the locking lever.
Use the flat compression plate or the compression spoon for selective spot view. In
the latter case, an external diaphragm shall be used.
MAM00053

Figure 46. Flat compression plate and compression spoon

50 Operator Manual
SPB7-230.201.08.06.02
Operation

Biopsy Attachment with Shadow Cross (Option)


The biopsy attachment consists of an external diaphragm marked “SHADOW
CROSS”, a shadow-cross unit, and a biopsy compression plate with coordinate scale.
Please refer to separate Instructions for use.

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

Biopsy compression plate


MAM00054

with coordinate scale

Figure 47. Biopsy attachment with shadow cross

MAMMOMAT 1000/3000 Nova 51


SPB7-230.201.08.06.02
Function and Safety Check

Function and Safety Check


Daily Checks
Before Examination
• Visually check all displays and indicator lamps on the control panel and the
stand.

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.

Error Indication Lamps

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

Turn the swivel-arm system 180°, so that the tube head is


straight upside down. Lower the system as close to the floor
as possible. Check that the error indication lamp is lit. Raise
and turn the swivel-arm system back again and check that the
lamp goes out.

• 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.

MAMMOMAT 1000/3000 Nova 53


SPB7-230.201.08.06.02
Protective Measures

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.

Emergency Stop Button


If an equipment malfunction causes an emergency situation, which would involve a
hazard for the patient, the operator or for the equipment itself, press the red emer-
gency stop button on the unit.
All unit drives will be switched off and all movements will be interrupted. However, it
may still be possible to generate radiation.
Decompression must be carried out manually.
The button may be released (by turning it clockwise) only if the cause of danger has
been clearly recognized and eliminated.
Should the expected switch-off function not work, immediately press one of the
emergency shutdown switches (see above). This switch will then immediately dis-
connect the whole system.
In this case, the system must not be put into operation again. Customer service 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

Figure 48. MAMMOMAT, radiation protection

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.

MAMMOMAT 1000/3000 Nova 55


SPB7-230.201.08.06.02
Protective Measures

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

Checking the Automatic Exposure Control (AEC)


• Select a kV value.
• Activate AEC mode.
• Set the density to “+00”.
• Release the exposure.
The radiation-indicator lamp shall be lit for a very short time only (less than 0.15 s).
• Place a lead cover over the object table.
• Release an exposure with the same generator setting.
While the exposure-release buttons are depressed, the radiation-indicator lamp must
be lit until the exposure is interrupted by the automatic exposure control.
The acoustic signal is sounded and the limit lamp is lit.
• Press the limit button to switch off the limit lamp.

56 Operator Manual
SPB7-230.201.08.06.02
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


operating staff

Hazard areas
for patient

Stand with pivoted object-table arm (MAMMOMAT 3000 Nova only)

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

Figure 50. Critical hazard areas

MAMMOMAT 1000/3000 Nova 57


SPB7-230.201.08.06.02
Protective Measures

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.

Figure 51. Hazard areas

Safety-relevant Parts Subject to Wear


This unit contains the following safety-relevant parts, which should be checked every
year and, if required, replaced:
• Steel rope (for counterbalance)
• Object-table connector
• Compression thickness potentiometer
• Brake magnets
• Collimator lamp
• Connecting cable between separate control console (option) and generator
• Batteries in the remote control (option for MAMMOMAT 1000)

58 Operator Manual
SPB7-230.201.08.06.02
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.

Radiation Protection Material


• Lead, placed in the X-ray tube, approximately 0.8 kg
• Lead in solderings on the circuit boards, approximately 0.5 kg
• Lead in the shield glass, approximately 6 kg

Other Metal
• In the X-ray tube Beryllium, approximately 0.7 g
Nickel, approximately 50 g
Molybdenum/Tungsten, approximately 560 g

Transformer Oil, type Shell 4655


• Oil, placed in the X-ray tube, approximately 3 l
• Oil, placed in high-voltage generator, approximately 5 l

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)

MAMMOMAT 1000/3000 Nova 59


SPB7-230.201.08.06.02
Protective Measures

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
SPB7-230.201.08.06.02
Identification Labels

Identification Labels
Stand

SIEMENS
Röhre/Tube P 40 MoW
MODEL-NO.

SERIAL-NO. S20

0.15/2x 0.3/2x IEC 336


Siemens Aktiengesellschaft, Wittelsbacher Platz 2,D-80333 München (Germany)

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

xxxx/xx IEC 522 xxxxx/xxxx


S SIF X-Ray Equipment
LA IE
Xxxxx xx xxxxxxxxxxx xxx MADE IN
C
UL D
xxxxx xxxx xxx xxxx xxx xxx
xxxxxxxxx xxxx xxxxx xxx xx GERMANY
R
xxxxx xxx xxx xxx xx xxx x
0123

SIEMENS

(1P) Model No. 01234567 0123

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

With Respect to Electrical


Shock, Fire and Mechanical
Hazards only.
245B
s
Item. Stand

(1P) Model No.

IVK
(S) Serial No.

Made in Sweden

X-ray Equipment

Classified by

Only for Russia


Underwriters Laboratories Inc. ®
with Respect to Electrical Fire Shock
and Mechanical Hazards Drty.
245 B

CERTIFIED TO THE REQUIREMENTS


OF THE CANADIAN ELECTRICAL
CODE. CSA HAS NOT INVESTIGATED
® OTHER PHYSIOLOGICAL EFFECTS.
LR56549C CERTIFIÉ SELÓN LES EXIGENCES DU
CÓDE CANADIEN DE L'ÉLECTRICITE.
L'ACNOR N'A PAS E'TUDIÉ LES AUTRES
EFFETS PHYSIOLOGIQUES POSSIBLES.

110V, 208V, 230V


240V, 277V, 400V
1 - 2 phase 50/60 Hz

Momentary 10 kVA
Long-time 0.8 kVA

MAM00943

Figure 52. Labels, Stand

MAMMOMAT 1000/3000 Nova 61


SPB7-230.201.08.06.02
62
Generator

for USA
Identification Labels

Figure 53. Labels, Generator


SIEMENS

X-Ray Equipment
(1P) Model No. 01234567
0123 R

With Respect to Electrical


System
(S) Serial No. 1001 IVK Shock, Fire and Mechanical
2004
Hazards only.
Siemens Aktiengesellschaft, Wittelsbacherplatz 2, DE-80333 Muenchen
245B
Made in Germany

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

MAMMOMAT 1000/3000 Nova


Wittersbacherplatz 2, D - 80333 München
Germany
Separate Control Console

This product complies with DHHS regulations


21 CFR Subchapter J. applicable at date of

Figure 54. Labels, Separate control console


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 manufacture.
Manufactured:
Siemens Aktiengesellschaft
Wittersbacherplatz 2, D - 80333 München
Germany

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.

Remove replaceable plastic tray of the stereo compression plate

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.

Attach replaceable plastic tray of the stereo compression plate

64 Operator Manual
SPB7-230.201.08.06.02
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.

MAMMOMAT 1000/3000 Nova 65


SPB7-230.201.08.06.02
Technical Specifications

Technical Specifications
Tube rating charts
Anode Heating Curves and Cooling curve
P 40 Mo W

Figure 55. Anode heating curves and cooling curves

66 Operator Manual
SPB7-230.201.08.06.02
Technical Specifications

Cooling and Heating Curves for the X-ray Tube Assembly

Figure 56. X-ray tube heating curves and cooling curve with fan

Room temperature 21° C


Mean rotor power 90 W

MAMMOMAT 1000/3000 Nova 67


SPB7-230.201.08.06.02
Technical Specifications

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

Power supply 110 V, single phase;


208 V, 240 V, 277 V, single or two phase,
400 V, two-phase,
50 or 60 Hz
Permissible supply mains ±10%
voltage fluctuations
Power-supply fuse 20 A; 35 A at 110 V
Power input 10 kVA (momentary)
0.8 kVA (long-time load)

Generator

High voltage wave form Multipulse (high frequency)


Exposure voltage 23 kV to 35 kV, in steps of 1 kV
mAs range (at 25 kV and Mo tube: 2 mAs to 560 mAs in mAs mode
maximum power) 0 mAs to 600 mAs in AEC mode
MAMMOMAT 3000 Nova only Mo/W tube: 2 mAs to 710 mAs in mAs mode
0 mAs to 752 mAs in AEC mode
Exposure times 10 ms to 4 s for screening
10 ms to 7 s for magnification technique
kV accuracy ± 5% (measured in the high-voltage circuit)
mAs accuracy ± 10% (measured in the rectified high-voltage cir-
cuit)

Radiation Shield

Integrated with generator Lead glass: 0.30 mm Pb Eq


Free-standing (option) Lead glass: 0.10 mm or 0.30 mm Pb Eq

68 Operator Manual
SPB7-230.201.08.06.02
Technical Specifications

Automatic Exposure Control

Automatic exposure control AEC Semiconductor detectors


with transparency compensation
Detectors
The AEC functions for all available kV-settings (23 kV to 35 kV).
At appropriate clinical kV and variable object thickness (2-6 cm) the accuracy of opti-
cal density is ± 0.15 OD from the mean optical density for predefined film/screen
combinations.
This applies separately for each object table and anode/filter combination (prerequi-
site: constant development conditions, gamma = 3 to 5).
Density correction ± 3 exposure points, adjustable in 1/8 exposure
points. The display shows values between -24
and + 24.
Film-screen combinations Two can be selected by the user on the generator
control console.

X-ray Tube Assembly

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

MAMMOMAT 1000/3000 Nova 69


SPB7-230.201.08.06.02
Technical Specifications

PANTIX 40 MoW - 100G

Nominal voltage (IEC 613) 40 kV


Focus F1 F2 F3 F4

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

* For reference directions 20°/17° see dimensional drawing.

70 Operator Manual
SPB7-230.201.08.06.02
Technical Specifications

Electrical Data

Internal line impedance UN[V] Rimax[Ω]


110 0.25
208 0.45
230 0.50
240 0.60
277 0.65
400 0.85

Weight and heat dissipation

Weight [kg] Heat dissipation [W]


Stand with X-ray tube assembly approx. 285 approx. 200
including base plate
Generator including base plate approx. 139 approx. 680
and radiation protection shield

Table attenuation factor

Measured in a Mammography beam (25 kV, Mo/Mo), HVL (mm AL)


18x24 Bucky table 0.06 - 0.08
24x30 Bucky table 0.09 - 0.14
Mag table 1.5 and 1.8 0.11 - 0.13

MAMMOMAT 1000/3000 Nova 71


SPB7-230.201.08.06.02
Technical Specifications

Calculated absorbed glandular dose


The dose value is a theoretically calculated value based on exposure and source table
data.

Exposure data: Target / filter combination


kV value
mAs value
Compressed breast thickness
Focus (large or small)
Focus-table top distance
Source table data: Glandular dose data for 50/50% (glandular tissue /
fatty tissue)
Dose Exchange values (mGy / mAs)
HVL values (half value layer, thickness of alumi-
num that reduces the dose to 50%)

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.

72 Operator Manual
SPB7-230.201.08.06.02
Technical Specifications

Classifications

Leakage technique factors* 35 kVp/100 mAs, 124 exposures/h


Beam quality (HVL) > 0.25 mm Al at 25 kV
Protection against electrical Class I, applied part type B according to
shock IEC 60601-1
Mechanical stability of stand The equipment does not overbalance when tilted
and generator (equipment through an angle of 10° from the horizontal in any
not secured to the floor by position of normal use (IEC 60601-1) or is sub-
jected to a force of 222.5 N applied 1.52 m above
bolting)
floor level (UL 187). Free-standing radiation shield
and separate generator must be bolted to the
floor.
Degree of protection against Ordinary equipment (enclosed equipment with-
ingress of water out protection against ingress of water, protection
Class IP X0 (IEC 60529).
Degree of safety of application Not suitable
in the presence of flammable
anesthetic mixture with air or
nitrous oxygen
Mode of operation Continuous operation
Technique factors for testing 35 kV, maximum mAs
the primary protective shielding
(beam stopper)

* 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)

Transport and storage

Ambient temperature -10° to +70° C


Relative humidity 10 to 100%
Atmospheric pressure 700 to1060 kPa

Operation

Ambient temperature -10° to +40° C


Relative humidity 30 to 70%
Atmospheric pressure 700 to 1060 kPa

MAMMOMAT 1000/3000 Nova 73


SPB7-230.201.08.06.02
Technical Specifications

Stand

650
+135˚
-180

2120
2033

650-1350
866

537
520
1091

MAM00691
640

Figure 57. Dimensions of the stand

Maximum height 2120 mm


Isocentre height 693 mm – 1393 mm
Object table height 650 mm – 1350 mm
Source - image distance (SID) 650 mm
Rotation range of swivel-arm +135° (clockwise),
system -180° (counterclockwise)
Weight 300 kg (670 lbs) incl. base plate

74 Operator Manual
SPB7-230.201.08.06.02
Technical Specifications

Generator

885.5

1960

MAM00719
700 340
708 540

Figure 58. Generator with integrated control panel and radiation shield

Weight 141 kg (313 lbs) incl. radiation shield and base


plate

MAMMOMAT 3000 Nova


1080

MAM00723

530 290
330

Figure 59. Separate generator

Weight 130 kg

MAMMOMAT 1000/3000 Nova 75


SPB7-230.201.08.06.02
Technical Specifications

Free-standing Radiation Shield (Option)


1961

782 450

Figure 60. Free-standing radiation shield with separate control console

Weight 46 kg (without separate control console)

Separate Control Console

Mo Mo W
kV mAs AEC Mo Rh Rh Program Auto Lim.
WARNING
MAM00069

Figure 61. Separate control console

Dimensions 82 mm x 520 mm x 200 mm


Weight 4 kg

76 Operator Manual
SPB7-230.201.08.06.02
Technical Specifications

Notice concerning electromagnetic compatibility (EMC)


Medical electrical equipment is subject to special precautions regarding EMC and
needs to be installed and put into service according to the EMC information provided
in the accompanying documents.
Portable and mobile RF communications equipment can affect medical electrical
equipment.
Fixed equipment or system cabling that cannot be removed by the user is not listed.
This cabeling is part of the system and was considered in all EMC measurements.
Without this cabling the equipment or system would not function.

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.

MAMMOMAT 1000/3000 Nova 77


SPB7-230.201.08.06.02
Technical Specifications

Guidelines and manufacturer's declaration - electromagnetic emissions


The system is intended for use in an electromagnetic environment as specified be-
low. The customer or the user of the system should ensure that it is used in such an
environment.

Emissions test Compliance Electromagnetic environment - guidelines

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

RF emissions Class B The system is suitable for use in all establishments,


CISPR 11 including domestic establishments and those directly
connected to the public low-voltage power supply
Harmonic emissions Not applicable network that supplies buildings used for domestic
IEC 61000-3-2 purposes.

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
SPB7-230.201.08.06.02
Technical Specifications

Guidelines and manufacturer's declaration - electromagnetic immunity


The system is intended for use in an electromagnetic environment as specified be-
low. The customer or the user of the system should ensure that it is used in such an
environment.

Immunity test IEC 60601 Compliance Electromagnetic environment - guidelines


test level level

Electrostatic discharge ±6 kV contact ±6 kV contact Floors should be wood, concrete or ceramic


(ESD) tile. If floors are covered with synthetic mate-
IEC 61000-4-2 ±8 kV air ±8 kV air rial, the relative humidity should be at least
30%.

Electrical fast transient/ ±2 kV ±2 kV Mains power quality should be that of a typi-


bursts for power supply for power supply cal commercial or hospital environment.
IEC 61000-4-4 lines lines
±1 kV ±1 kV
for input/output for input/output
lines lines

Surges ±1 kV ±1 kV Mains power quality should be that of a typi-


IEC 61000-4-5 differential mode differential mode cal commercial or hospital environment.
±2 kV ±2 kV
common mode common mode

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

Power frequency 3 A/m 3 A/m Power frequency magnetic fields should be at


(50/60 Hz) levels characteristic of a typical location in a
magnetic field typical commercial or hospital environment.
IEC 61000-4-8

NOTE: UT is the a.c. mains voltage prior to application of the test levels.

MAMMOMAT 1000/3000 Nova 79


SPB7-230.201.08.06.02
Technical Specifications

Guidelines and manufacturer's declaration - electromagnetic immunity


The system is intended for use in an electromagnetic environment as specified be-
low. The customer or the user of the system should ensure that it is used in such an
environment.

Immunity test IEC 60601 test level Compli- Electromagnetic environment - guidelines
ance
level

Portable and mobile RF communications equip-


ment should be used no closer to any part of the
system, including cables, than the recommended
separation distance calculated from the equation
applicable to the frequency of the transmitter.

Recommended separation distance:


Conducted 3 Vrms 3 Vrms d = 1.2 P
RF disturbances 150 kHz to 80 MHz
IEC 61000-4-6

Radiated 3 V/m 3 V/m d = 1.2 P for 80 MHz to 800 MHz


RF disturbances 80 MHz to 2.5 GHz
IEC 61000-4-3 d = 2.3 P for 800 MHz to 2.5 GHz

Where P is the maximum output power rating of


the transmitter in watts (W) according to the
transmitter manufacturer and d is the recom-
mended separation distance in meters (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey, a
should be less than the compliance level in each
frequency range.b
Interference may occur in the vicinity of equip-
ment marked with the following symbol:

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
SPB7-230.201.08.06.02
Technical Specifications

Recommended separation distances between portable and mobile RF communica-


tions equipment and the system
The system is intended for use in an electromagnetic environment in which radiated
RF disturbances are controlled. The customer or the user of the system can help pre-
vent electromagnetic interference by maintaining a minimum distance between por-
table and mobile RF communications equipment (transmitters) and the system as
recommended below, according to the maximum output power of the communica-
tions equipment.

Separation distance according to frequency of transmitter [m]


Rated maximum
output power of 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
transmitter [W] d = 1.2 P d = 1.2 P d = 2.3 P

0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.73

1 1.2 1.2 2.3

10 3.8 3.8 7.3

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.

MAMMOMAT 1000/3000 Nova 81


SPB7-230.201.08.06.02
Technical Specifications

List of compatible components

Description Material Manufacturer


number
Adapter kit Mammotome to Mammotome from Ethicon 06483080 Siemens AG
(MAMMOMAT 3000 Nova only)
Beam limiting device (BLD) 06245000 Siemens AG
MAMMOMAT 3000 Nova only
Beam limiting device (BLD) 06438464 Siemens AG
Beam limiting device (BLD) 06521590 Siemens AG
MAMMOMAT 1000 with single filter only
Biopsy device/shadow cross 06294446 Siemens AG
Bus installation kit 06421148 Siemens AG
Compression plates
• Axilla 18x24 cm 06483478 Siemens AG
• Biopsy hole plate 06258086 Siemens AG
• Detail spot contact mode 06421015 Siemens AG
• Flexible high edge 18x24 cm 06561281 Siemens AG
• Flexible high edge 24x30 cm 06561299 Siemens AG
• High edge 18x24 cm 06483486 Siemens AG
• High edge 24x30 cm 06483494 Siemens AG
• Low edge 18x24 cm 06483452 Siemens AG
• Low edge 24x30 cm 06483460 Siemens AG
• Magnification 1.5 06483502 Siemens AG
• Magnification 1.8 06483510 Siemens AG
• Shadow cross 06258078 Siemens AG
• Spot Magnification 1.5 06421023 Siemens AG
• Spot Magnification 1.8 06421031 Siemens AG
• Stereo 06294073 Siemens AG
10093428 Siemens AG
Exposure release handle 06438951 Siemens AG
External Diaphragms (BLD)
• Axilla 18x24 cm 06258136 Siemens AG
• Magnification 06483700 Siemens AG
(MAMMOMAT 1000 with single filter only)
• Shadow cross 06294370 Siemens AG
• Spot contact mode 06258110 Siemens AG
• Spot Magnification 1.5 and 1.8 06258185 Siemens AG
• Spot Magnification 06258477 Siemens AG
(MAMMOMAT 1000 with single filter only)
• Stereo 06258193 Siemens AG
(MAMMOMAT 3000 Nova only)
• 18x24 (MAMMOMAT 1000 with single filter only) 06483692 Siemens AG

82 Operator Manual
SPB7-230.201.08.06.02
Technical Specifications

Description Material Manufacturer


number
Free-standing radiation shield
• Holder for radiation shield 06438894 Siemens AG
• Lead glass 0.1 mm 06431774 Siemens AG
• Lead glass 0.3 mm 06461356 Siemens AG
Object tables
• Object table with Bucky 18x24 cm 06607969 Siemens AG
• Object table with Bucky 18x24cm 06607985 Siemens AG
• Object table with Bucky 24x30 cm 06607977 Siemens AG
• Object table with Bucky 24x30 cm 06616481 Siemens AG
• Object table without grid 18x24 cm 06431626 Siemens AG
• Object table without grid 24x30 cm 06431634 Siemens AG
• Object table Magnification table 1.5 06483742 Siemens AG
• Object table Magnification table 1.8 06483759 Siemens AG
Opdima
• Opdima CCD camera 06397439 Siemens AG
• Opdima Biopsy Controller Unit 06430305 Siemens AG
• Opdima Workstation 06430453 Siemens AG
• Opdima Trolley 06430321 Siemens AG
Printer connection kit 06382852 Siemens AG
Triacon Network ID Camera
• Triacon Network ID Camera 06522432 Triacon Scientific AB
• Adapter cable for Triacon camera 06561521 Triacon Scientific AB
• Terminating plug for dangling printer cable 06561513 Triacon Scientific AB
• NICLan Modul for Triacon camera 08383478 Triacon Scientific AB
Remote control 06521749 Siemens AG
(MAMMOMAT 1000 only)
Remote control kit 06522176 Siemens AG
(MAMMOMAT 1000 only)
Stereotactic Biopsy unit 06293588 Siemens AG
(MAMMOMAT 3000 Nova only)
Stereotactic Evaluation unit 06293851 Siemens AG
(MAMMOMAT 3000 Nova only)
Tube housing assembly P 40 Mo/W-100G 01125314 Siemens AG
X-ray control 06438506 Siemens AG
X-ray control remote panel 06438599 Siemens AG
X-ray high-voltage generator 08611105 Siemens AG

MAMMOMAT 1000/3000 Nova 83


SPB7-230.201.08.06.02
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
SPB7-230.201.08.06.02
© Siemens AG 2006
All rights reserved

Contact address:

Siemens AG Siemens AG, Medical Solutions


Wittelsbacherplatz 2 Special Systems
D-80333 München Henkestraße 127 Order No.: SPB7-230.201.08.06.02
Germany D-91052 Erlangen Printed in the Federal Republic of Germany
Germany AG 06/06

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