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Mammomat Fusion

Planning Guide
System
Mammomat Fusion VB50

Answers for life.


2 Document Version / Disclaimer / Copyright

Document Version
Siemens reserves the right to change its products and services at any time.
In addition, manuals are subject to change without notice. The hardcopy documents cor‐
respond to the version at the time of system delivery and/or printout. Versions to hard‐
copy documentation are not automatically distributed.
Please contact your local Siemens office to order a current version or refer to our website
http://www.healthcare.siemens.com.

Disclaimer
Siemens provides this documentation “as is” without the assumption of any liability under
any theory of law.
The content described herein shall be used by qualified personnel who are employed by
Siemens or one of its affiliates or who are otherwise authorized by Siemens or its affiliates
to use such documents.
Assemblers and other persons who are not employed by or otherwise directly affiliated
with or authorized by Siemens or one of its affiliates are not entitled to use this documen‐
tation without prior written authority.

Copyright
“© Siemens, 2013” refers to the copyright of a Siemens entity such as:
Siemens Healthcare GmbH - Germany
Siemens Aktiengesellschaft - Germany
Siemens Shenzhen Magnetic Resonance Ltd. - China
Siemens Shanghai Medical Equipment Ltd. - China
Siemens Medical Solutions USA Inc. - USA
Siemens Healthcare Diagnostics Inc. - USA and/or
Siemens Healthcare Diagnostics Products GmbH - Germany

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Table of Contents 3

1 General Information 5

1.1 Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5


1.1.1 Hazard notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
1.2 System Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
1.3 Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
1.3.1 Scope of this document. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
1.3.2 Planning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
1.3.3 Actions for Winter Deliveries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
1.4 Product-specific Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
1.4.1 Network. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
1.4.2 Virus Protection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
1.4.3 Workflow . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
1.4.4 DICOM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
1.4.5 Siemens Remote Services connection. . . . . . . . . . . . . . . . . . . . . . 11
1.4.6 Recommended viewing stations (Siemens Viewing Stations) . . . 11
1.5 Conventions and Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
1.6 Scope of delivery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
1.7 Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

2 Room planning 17

2.1 General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17


2.1.1 Information regarding dimensions and orientation points. . . . . . 17
2.1.2 Safety information regarding the Single Touch function . . . . . . . 17
2.1.3 Requirements for Lighting per DIN V 6868-57 . . . . . . . . . . . . . . . 18
2.2 Room Sizes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
2.2.1 Room Planning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
2.2.2 Sample Layout with Separate Control Room. . . . . . . . . . . . . . . . . 21
2.3 Component Dimensions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
2.3.1 Stand Dimensions and Center of Gravity . . . . . . . . . . . . . . . . . . . 22
2.3.2 Unit Base Dimensions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
2.3.3 Control console with radiation shield dimensions . . . . . . . . . . . . 24
2.3.4 Acquisition Workstation Dimensions. . . . . . . . . . . . . . . . . . . . . . . 25
2.3.5 Control box dimensions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
2.4 Radiation protection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
2.5 Notice concerning electromagnetic compatibility (EMC) . . . . . . . . . . . . . . . 28
2.5.1 Guidelines and manufacturer's declaration – electromagnetic 28
emissions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.5.2 Guidelines and manufacturer's declaration – Electromagnetic 29
interference immunity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.5.3 Guidelines and manufacturer's declaration – Electromagnetic 31
interference immunity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.5.4 Recommended separation distances between portable and mo‐ 32
bile RF telecommunication devices and the system . . . . . . . . . . .

3 Preparation for Installation 33

3.1 Information regarding expansion bolts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

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3.2 Stand - Floor Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34


3.2.1 Stand - information regarding floor anchoring . . . . . . . . . . . . . . . 34
3.3 Control console - floor installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
3.3.1 Control console - information regarding floor anchoring . . . . . . . 37
3.4 Potential Equalization Connection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
3.5 On-site Electrical Installation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
3.5.1 Safety Shutdowns . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
3.5.2 Power connection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
3.5.3 External indicator for X-ray or door contact . . . . . . . . . . . . . . . . . 41
3.5.4 Example for on-site Power Distributor (1-phase, 2-phase) ac‐ 42
cording to DIN VDE 0100-710 or National Regulations, and tak‐
ing into account the use of SIRIUS . . . . . . . . . . . . . . . . . . . . . . . .
3.6 Siemens Remote Services (SRS) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46

4 System Connections 47

4.1 General information on wiring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47


4.1.1 Power Line Voltage and Ground Wire Connections . . . . . . . . . . . 47
4.1.2 Signal and Data Cables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
4.2 Wiring diagram - fixed points . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
4.2.1 Definition of fixed points . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
4.2.2 Distances between fixed points . . . . . . . . . . . . . . . . . . . . . . . . . . 49
4.3 Cable Inlets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
4.4 Cable Conduits and Cable Ducts - Minimum Size . . . . . . . . . . . . . . . . . . . . . 52

5 Technical Data 53

5.1 Dimensions and Weights, Heat Dissipation. . . . . . . . . . . . . . . . . . . . . . . . . . 53


5.1.1 Dimensions and Weights. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
5.1.2 Heat dissipation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
5.2 Climatic Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
5.2.1 Temperature, Relative Humidity and Barometric Pressure . . . . . . 54
5.3 Electrical Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
5.3.1 MammoUnit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
5.3.2 Workstation and Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
5.4 Paint Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57

6 Transport and Storage Conditions 58

6.1 Climatic Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58


6.2 Transport Dimensions and Weights. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59

7 Changes to Previous Version 60

8 List of Hazard IDs 61

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1.1 Safety Information


n The system may be used only in rooms intended and prepared for medical purposes.
n In accordance with national radiation safety measures, the room must be prepared
with the purpose of performing medical radiographic examinations.
n The national radiation safety measures must be observed.
n The national regulations in force apply primarily. However, we strongly recommend
adherence to the standards described herein - provided they do not contradict nation‐
al regulations in effect - to ensure the safety of operators, patients, and third parties.
n The rooms intended for this medical device must meet the ordinances of the respec‐
tive national fire safety measures.
n The device was developed to meet the requirements of Protection Class I, Type B
against electric shock, in accordance with IEC 60601-1.
n Comply with the recommendations for prevention of electromagnetic discharges and
overvoltages as defined in IEC 1024, DIN 48810, VDE 0675, and DEMVT. See also the
"Room Planning" chapter in this document.
n Minimum data (e.g. room height, safety distances) are identified in the Planning
Guide as "min."
n Mechanical stability of stand (system not secured to the floor by bolting)
- The equipment does not overbalance when tilted through an angle of 5° from the
horizontal in any position of normal use (IEC 60101-ff) or is subjected to a force of
220 N applied 1.50 m above floor level (UL 187).
The device may only be transported in horizontal position, or in vertical position if
the tube arm is in its lowest position.
n Refer to operating instructions for more information.

1.1.1 Hazard notes

 CAUTION
Incorrect service or maintenance of the Mammomat, including its options, can
cause serious bodily injury.
INJURY TO PATIENT / PROPERTY DAMAGE
 Only trained personnel should perform installation and service activities. See
safety regulations for installation and maintenance (ARTD-002.731.1)
hm_DOC_F17G2U4M1 04H394682

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 CAUTION
Danger of tipping over.
BODILY INJURY, FALLING OBJECTS
 In earthquake-prone areas, the MammoUnit stand and the control console
must be fastened to the floor.
hm_DOC_F14G5U1M2 04H394032

 CAUTION
The occurrence of static electricity in the examination room can cause injury or
damage to system components if the Mammomat Fusion is touched.
RISK OF INJURY
 Construction conditions that promote the generation and discharge of static
electricity (e.g. laying highly insulated flooring) should be avoided.
hm_DOC_F14G8U4M1 04H394112

 CAUTION
Unintended movement because system fails to stop moving during an emergen‐
cy.
INJURY TO THE PATIENT
 The emergency off switch must be installed in the room. The emergency off
switch turns off the system; radiation and mechanical movements are inter‐
rupted
hm_DOC_F4G1U21M1 04H392814 / hm_DOC_F4G1U21M2 04H392815

 CAUTION
System insufficiently cooled off
PROPERTY DAMAGE
 Climatic conditions must be observed
hm_DOC_F14G3U1M4 04H393925

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 CAUTION
Software virus attack
PROPERTY DAMAGE
 Follow planning prerequisites.
hm_DOC_F8G2U1M4 04H393531

 CAUTION
Patient or machine operator crushed
RISK OF INJURY
 The side safety area for automatic stand-arm movement is 1290 mm from the
middle of the unit (at least 500 mm safety distance from the tube unit arm in
the +/- 90˚ position).
 A mark on the floor indicating the side safety area is recommended.
 If safety area cannot be kept free, even temporarily, of chairs, shelves, table
or similar items, switch off the "Single Touch" function.
hm_DOC_F4G1U1M2 04H392727/ hm_DOC_F4G1U1M3 04H392728 /
hm_DOC_F4G1U1M8 04H392733

 CAUTION
Insufficient distance between moving parts and fixed structures in the room
RISK OF INJURY
 Additional grounding must be installed if distance between the MammoUnit
and the control console is less than 0.75 m
hm_DOC_F4G1U1M11 04H392736

 CAUTION
Insufficient distance between moving parts and fixed structures in the room
RISK OF INJURY
 The patient area is 1.5 m around the MammoUnit stand
hm_DOC_F4G1U1M10 04H392735

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1.2 System Configuration


Mammomat Fusion is a radiography system with digital image processing developer for
mammography.
The system is comprised of the following components:
n Stand (MammoUnit) with single tank (X-ray tube assembly), high-voltage generator,
detector (digital image generation), and collimator to limit the beam.
n Control console (height adjustable) with radiation shield
n Workstation (computer) with monitor(s) integrated into the control console
n Control panel (on/off as well as radiation release) in the control console
Image data are exchanged between the workstation and DICOM PACS stations using the
hospital network.

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1.3 Notes

1.3.1 Scope of this document


Distribution of this document marked with this revision level replaces and voids all previ‐
ous versions.

1.3.2 Planning
All construction plans produced by the Planning Departments must be provided with a
note referring to the corresponding installation and delivery conditions. The installation
and delivery conditions must be enclosed with the project plans when shipped.

1.3.3 Actions for Winter Deliveries


During winter or when temperatures are <10°C during transport, plan at least 12 hours
during which the delivered components adapt to the climactic conditions in the examina‐
tion rooms prior to being switched on. Any installation team wait time is charged to the
local project.

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1.4 Product-specific Information

1.4.1 Network
As a digital image processing system, the acquisition workstation is connected to the hos‐
pital network for the mammography worklflow. Because of the data throughput required,
we recommend a network with 100 MB/s minimum. All required network cables and
plugs must be available on site and fully functional prior to start-up of the Mammomat
Fusion.
To avoid problems during start-up, check for and resolve any conflict in network address‐
es with the hospital network before installation.
The standard IP addresses of the subnet in our product are: 192.168.0.2 and
192.168.0.100.

1.4.2 Virus Protection


The workstation with the Windows operating system has to be protected in the hospital
network from the public Internet using appropriate measures, such as a firewall for exam‐
ple, to prevent software changed by viruses.

1.4.3 Workflow
The hospital IT workflow (data exchange to other DICOM modalities in the hospital)has to
be discussed with the customer prior to start-up of the Mammomat Fusion and defined
for system configuration,

1.4.4 DICOM
The international DICOM protocol is used for image data transfer to and from Mammomat
Fusion.
To ensure the interoperability of DICOM components communicating to exchange data in
complex hospital networks, the required DICOM partners should be listed and compared
with the DICOM Interoperability Database:

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Fig. 1: Hospital network

1.4.5 Siemens Remote Services connection


Establish the connection to Siemens Remote Service. A DSL/VPN broadband connection is
recommended for Siemens Remote Service. Further information can be found in the "Sie‐
mens Remote Service" section.

1.4.6 Recommended viewing stations (Siemens Viewing Stations)


The recommended viewing stations for Mammomat Fusion are:
n syngoMammoReport
n syngo Breast Care Workstation
n Syngo Via Server with Breast Care Clients

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1.5 Conventions and Abbreviations


Abbreviation Meaning
CBS Control Board Stand, stand assembly, MammoUnit
DICOM Digital Imaging and Communications in Medicine
EMC Electro-magnetic compatibility
IP Internet Protocol
IT Information Technology
MRI Magnetic resonance imaging systems in clinical oper‐
ation

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1.6 Scope of delivery


The base version of the Mammomat Fusion system contains the following components:
1. MammoUnit (stand) with control panel (control box), including detector and single-
tank (X-ray tube assembly)
2. Acquisition Workstation (WH AWS) with monitor and control panel (control box)
3. Control console with radiation shield
Fig. 2: Stand Mammo Unit

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Fig. 3: Control box

Fig. 4: AWS Workstation

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Fig. 5: Control console with radiation protection shield

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1.7 Options
Optional accessories (including a magnification table) can be ordered.
The complete scope of delivery with order numbers and optional available components
can be found in the price book.

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2.1 General Information

2.1.1 Information regarding dimensions and orientation points


n Unless otherwise stated, all dimensions are in "mm".
n Orientation points are:
Points belonging to system components to which reference is made when system
parts are positioned to one another or in the room.
n Fixed points are:
Clearly designated points on system components, walls or floors at which cable out‐
lets are located.
The illustrations in the drawings are: Octagon with letter / number combination.
The cable lengths define the maximum fixed-point distances, and thus the maximum
distances between the individual system components.
n Room height
The room height is the clear space measured from the top edge of the finished floor
to the bottom edge of the ceiling sub-structure (bottom edge of the finished ceiling).

2.1.2 Safety information regarding the Single Touch function

NOTICE
The Single Touch function is available for the Mammomat Fusion stand. Here, au‐
tomated movement routines are started at the press of a button.
If persons are standing or equipment is located in the safety area during automat‐
ic movements, it may lead to bodily injury or equipment damage.
 The side safety area for automatic stand-arm movement is 1290 mm from the
middle of the unit (at least 500 mm safety distance from the tube unit arm in
the +/- 90˚ position).
 A mark on the floor indicating the side safety area is recommended.
 If safety area cannot be kept free, even temporarily, of chairs, shelves, table
or similar items, switch off the "Single Touch" function.

NOTICE
The occurrence of static electricity in the examination room can cause injury or
damage to system components if the Mammomat Fusion is touched.
 Construction conditions that promote the generation and discharge of static
electricity (e.g. laying highly insulated flooring) should be avoided.

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2.1.3 Requirements for Lighting per DIN V 6868-57


n Room lighting
According to DIN V 68 68-57 (international standard in preparation), the lighting in
rooms in which medical images are displayed on video display units (monitors) must
meet the following requirements:
- adjustable, glare-free, and reproducible setting of brightness (e.g. dimmer with
scale)
- no reflections from windows, lamps and viewing boxes when the monitors are in
their standard operating position.

 The Mammomat Fusion workstation monitors have not been approved for use as a diag‐
nostic workstation.

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2.2 Room Sizes

2.2.1 Room Planning


Fig. 6: Room sizes

A X-ray tube assembly focus


*1 n Distance of at least 150 mm from the wall if the stand is not anchored to the floor (service
can performed at the back by sliding the stand out).
n Distance of at least 500 mm from the wall if the stand is anchored to the floor (necessary
for service at the back of the stand).

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*2 2 cable conduits (each 2 m) are included in the shipment for laying cables "on the floor".
If needed, additional cable conduits, Part No. 64 38 795 X041E, can be ordered for the connec‐
tion between the stand and the radiation shield.
*3 For safety reasons (electrical components that can be touched by the patient), the acquisition
workstation (installed in the control console as standard) as well as any evaluation stations in
the room, should be set up outside of a radius of 1.5 m from the stand in accordance with IEC
60601-1, 3rd Edition.
Note: If for construction reasons the distance from the MammoUnit to the control unit has to
be reduced, the control console (including workstation) must be connected to the MammoUnit
potential equalization.
The 50 cm safety distance to moveable parts must always be maintained.
The local radiation safety regulations relative to the reduced distance must be observed.
Monitors and Monitor Support Arm
One or two monitors can be attached to the control console. The monitor can be installed to
the right (default) or left. A longer DVI cable (3 m) is required for left installation (see the notes
in the System Cabling section). A swivel; range of +/- 90° with a tolerance of +/- 1° can be set
for the lower monitor support arm. An inward swivel range of 90° (tolerance +/- 1°) and an out‐
ward swivel range of 125° (tolerance +/- 1°) can be set for the upper monitor support arm.

 Observe the maximum fixed-point distances ( Distances between fixed points


/ Page 49).

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2.2.2 Sample Layout with Separate Control Room


Fig. 7: Sample Layout with Control Room

 If the control room is separate, audiovisual communication with the patient has to be
ensured, for example, through a window to the patient room and an intercom system.

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2.3 Component Dimensions

2.3.1 Stand Dimensions and Center of Gravity

 By adjusting the end switch, you can reduce the maximum stand height by about 32 cm
if necessary.

Fig. 8: Stand

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Fig. 9: Stand centers of gravity

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2.3.2 Unit Base Dimensions


Fig. 10: Unit base

2.3.3 Control console with radiation shield dimensions


Cables can be routed from the sides or from below.

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Fig. 11: Control console dimensions

2.3.4 Acquisition Workstation Dimensions

Fig. 12: AWS Workstation Acquisition Workstation Dimensions:


(W x D x H) 215 x 520 x 446 mm

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26 2 Room planning

2.3.5 Control box dimensions

Fig. 13: Control box Control Box Dimensions:


height approx. 55 mm
diameter approx. 200 mm

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Room planning 2 27

2.4 Radiation protection


The on-site radiation shield depends on the setup location of the medical device in the
room and on the function of the adjacent rooms. Follow and comply with this informa‐
tion

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28 2 Room planning

2.5 Notice concerning electromagnetic compatibility (EMC)


Medical electrical equipment is subject to special precautions regarding EMC. These sys‐
tems must be installed and put into service in accordance with the EMC guidelines provi‐
ded in the accompanying documents.
Portable and mobile RF communications equipment can affect medical electrical equip‐
ment.

When using the unit or system in close proximity to or stacking with other units:
Proper operation is not guaranteed! ->
When operation near or stacked on other devices is required.
 If necessary, monitor the device or system to ensure proper operation is the arrange‐
ment used.
This could be the case for example in the vicinity of MRI systems, retail checkout scan‐
ners, or subways.

Permanently connected equipment or system cabling that cannot be removed by the


 user is not listed. This cabling is part of the system and was considered in all EMC meas‐
urements. Without this cabling the equipment or system would not function.

 WARNING
Note regarding accessories, converters, and cables that differ from the ones
specified:
Increased emission and reduced interference immunity of the unit or system are
possible when such items are used!
 Only use converters and cables that are sold by the manufacturer of the de‐
vice or system as replacement parts for internal components.

2.5.1 Guidelines and manufacturer's declaration – electromagnetic emissions


The system is intended for use in an electromagnetic environment as specified below.
The customer or the user of the system should ensure that it is operated in such an envi‐
ronment.

Interference emission Compliance Electromagnetic environment – Guidelines


measurements
RF emissions according Group 1 The system uses RF energy exclusively for its internal
to CISPR 11 function. Therefore, its RF emissions are very low and not
likely to cause any interference in nearby electronic
equipment.

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Room planning 2 29

Interference emission Compliance Electromagnetic environment – Guidelines


measurements
RF emissions according Class B The system is intended for use in all facilities, except for
to CISPR 11 housing facilities and facilities directly connected to a
public low-voltage power supply network that also sup‐
Harmonic current emis‐ Not applicable plies buildings used for housing.
sions according to IEC
61000-3-2 The system has a nominal input current of more than 16
A per phase.
Emissions of voltage Not applicable
fluctuations and flicker‐
ing
acc. to IEC 61000-3-3

NOTICE
Using the unit or system in close proximity to other units, or stacking with other
units.
Proper operation is not guaranteed!
 If it is necessary to operate this equipment or system near other devices or af‐
ter stacking it with other devices, then to observe the equipment or system to
monitor its proper operation in this arrangement.

2.5.2 Guidelines and manufacturer's declaration – Electromagnetic interfer‐


ence immunity
The system is intended for use in an electromagnetic environment as specified below.
The customer or the user of the system should ensure that it is operated in such an envi‐
ronment.

Immunity IEC 60601 Compliance Electromagnetic environment –


tests Test level level Guidelines

Electrostatic discharge ± 6 kV ± 6 kV Floors should be made of wood,


(ESD) Contact discharge Contact discharge concrete, or ceramic tiles. If the
IEC 61000-4-2 floor is covered with synthetic mate‐
or or rials, the relative humidity must be
± 8 kV ± 8 kV at least 30 %.
Air discharge Air discharge

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30 2 Room planning

Immunity IEC 60601 Compliance Electromagnetic environment –


tests Test level level Guidelines

Electrical fast transient / ± 2 kV ± 2 kV The line power quality should corre‐


bursts for power supply for power supply spond to that of a typical commer‐
according to IEC lines lines cial or hospital environment.
61000-4-4 or or
± 1 kV ± 1 kV
for input/output lines for input/output
lines
Surges ± 1 kV ± 1 kV The line power quality should corre‐
Surges Differential mode Differential mode spond to that of a typical commer‐
voltage voltage cial or hospital environment.
according to IEC
61000-4-5 or or
± 2 kV ± 2 kV
Common-mode volt‐ Common-mode
age voltage
Voltage dips, short in‐ < 5% VT Not applicable The line power quality should corre‐
terruptions, and fluctua‐ (> 95% dip in V ) for spond to that of a typical commer‐
T
tions of the power sup‐ 0.5 cycles cial or hospital environment. If the
ply voltage user of the system requires contin‐
according to IEC < 5% VT Not applicable ued operation during line power dis‐
61000-4-11 ruptions, it is recommended that
(> 95% dip in VT) for
the system be powered from an un‐
0.5 cycles
interruptible power supply.
70% VT Not applicable The system has a nominal input cur‐
(30% dip in VT) for 25 rent of more than 16 A per phase.
cycles
< 5% VT < 5% VT(> 95% dip
(> 95% dip in VT) for in VT) for 5 seconds
0.5 cycles
Power frequency (50/60 3 A/m 3 A/m Power frequency magnetic fields
Hz) magnetic field should be at levels characteristic of
according to IEC a typical location in a commercial or
61000-4-8 hospital environment.

Note: VT is the AC supply voltage prior to application of the test level.

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Room planning 2 31

NOTICE
Using the unit or system in close proximity to other units, or stacking with other
units.
Proper operation is not guaranteed!
 If it is necessary to operate this equipment or system near other devices or af‐
ter stacking it with other devices, then to observe the equipment or system to
monitor its proper operation in this arrangement. This could be the case in the
vicinity of MRI systems, retail checkout scanners, or subways.

2.5.3 Guidelines and manufacturer's declaration – Electromagnetic interfer‐


ence immunity
The system is intended for use in the electromagnetic environment as specified below.
The customer or the user of the system should ensure that it is operated in such an envi‐
ronment.

Immunity IEC 60601 Compliance Electromagnetic environment – Guidelines


tests test level level

n.a. n.a. n.a. 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 for the transmission frequency.
Conducted 3 Vrms 3 Vrms Recommended separation distance:
RF disturbances 150 kHz to d=1.2 √ P* for 80 MHz to 800 MHz
according to IEC 80 MHz
61000-4-6
Radiated RF interfer‐ 3 V/m 3 V/m Recommended separation distance:
ence according to 80 MHz to d=2.3 √ P* for 800 MHz to 2.5 GHz
IEC 61000-4-3 2.5GHz
Remark*: Where P is the maximum output power rating of the transmitter in watts (W) according to the
transmitter manufacturer, and d is the recommended 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 is possible in the vicinity of devices carrying the following symbol.

Remark 1: At 80 MHz and 800 MHz, the higher frequency range applies.
Remark 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects, and people.

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32 2 Room planning

Immunity IEC 60601 Compliance Electromagnetic environment – Guidelines


tests test level level
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 the‐
oretically with accuracy. To be able to assess the electromagnetic environment with regard to the station‐
ary transmitters, an electromagnetic site study should be considered. If the measured field strength at the
location where the system is used exceeds the applicable RF compliance level specified above, the system
should be observed to verify normal operation. Should unusual performance features be observed, addi‐
tional measures (such as change in orientation or change of site of the system) may be necessary.
b

Over the frequency range of 150 kHz to 80 MHz, the field strength should be less than 3 V/m.

2.5.4 Recommended separation distances between portable and mobile RF


telecommunication devices 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 prevent
electromagnetic interference by maintaining a minimum distance between portable and
mobile RF communications equipment (transmitters) and the system as recommended
below, according to the maximum output power of the communications equipment.

Power rating Separation distance according to frequency of transmitter [m]


of transmitter [W] 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
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 determined using the equation applicable to the
frequency of the transmitter, where P is the maximum output power rating of the transmit‐
ter in watts (W) according to the transmitter manufacturer.
Remark 1: At 80 MHz and 800 MHz, the higher frequency range applies.
Remark 2: These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects, and people.

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Preparation for Installation 3 33

3.1 Information regarding expansion bolts


n The specifications and instructions of the manufacturer must be observed for expan‐
sion bolts.
n Cut out an opening in the floor covering when installing the device on a solid floor.
n Installation materials must be obtained on site.

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34 3 Preparation for Installation

3.2 Stand - Floor Installation


The stand floor plate is designed to include the unit base.
The stand can be set up as follows:
1. Stand without floor anchoring
The stand is designed such that operation without floor anchoring is possible.
2. Stand with floor anchoring (5 anchoring points are provided)
Concrete quality for solid floors, min. C20/25.
Should anchoring to the floor be required due to local regulations (e.g. in seismic
areas) or due to the quality of the floor covering, the stand can be installed with
heavy-duty expansion bolts or threaded bolts (with counter plate).
The heavy-duty anchors and threaded bolts have to be procured locally.

3.2.1 Stand - information regarding floor anchoring

 Heavy-duty anchor is required for max. tensile force per mounting point of 1.5 kN

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Preparation for Installation 3 35

Fig. 14: Unit base floor installation

*1 n min. distance from wall is 150 mm when the stand is not anchored to the floor.
See ( Room planning / Page 17)
n min. distance from wall is 500 mm when the stand is anchored to the floor.
see (Access for Service Providers), ( Room planning / Page 17)

*2 Recess for laying cables

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36 3 Preparation for Installation

3.3 Control console - floor installation


The control console is equipped with a radiation shield; the workstation, monitor(s) and
control box are integrated.
The control console floor plate is designed to also serve as the unit base.
Fig. 15: Control console dimensions

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Preparation for Installation 3 37

Fig. 16: Control console with radiation shield and workstation

3.3.1 Control console - information regarding floor anchoring


n Control console mounting points
The control console can be set up as follows:
1. Control console without floor anchoring.
The control console is designed for operation without being anchored to the floor
(protection against tipping in locations subject to seismic risk).
2. The control console with floor anchor (2 anchor points provided) for areas subject to
an seismic risk. The anchor points are 126 mm from the side and 198 mm from the
front edge.
The heavy-duty anchors and threaded bolts have to be procured locally.
 Example: HILTI HSL M8-20 heavy duty expansion bolts

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38 3 Preparation for Installation

Fig. 17: Control panel anchor points

Fig. 18: Base plate attachment points

1 2

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Preparation for Installation 3 39

3.4 Potential Equalization Connection


To maintain the local legal regulations or if the spacing from the control console to the
stand (MammoUnit) is less than 1.5 m, lay a potential equalization cable between the
stand (line power connection terminal) and the control console. In addition, connect the
workstation to this control console potential equalization.

 The potential equalization cable with connection loop (cable lug d = 6 mm) is always rec‐
ommended.

The control console potential equalization connection point is located at the right foot
side.
Fig. 19: Potential equalization connection

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40 3 Preparation for Installation

Fig. 20: AWS WH ground connection

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Preparation for Installation 3 41

3.5 On-site Electrical Installation

3.5.1 Safety Shutdowns


Emergency Stop function
n The MammoUnit and control console (control box) are equipped with the emergency
stop function.
n Activating the emergency stop switch (on the right and left of the stand) blocks all
motorized movements. The system remains in operation.
n After disengaging the emergency stop switches, motorized movements are again pos‐
sible.
Emergency shutdown function
n To ensure the device is de-energized in the event of an emergency, an emergency
shutdown switch has to be installed.
n One or more emergency shutdown switches have to be installed so they can be
reached in the examination room by operating personnel. Pressing the switch de-en‐
ergizes the unit (stand, workstation, and an optional MoodLight). A SIRIUS safety shut‐
down is recommended.

3.5.2 Power connection


The power connection for the Mammomat Fusion is divided as follows:
n MammoUnit electric power connection with emergency shutdown, 1 or 2 phase with
neutral wire and protective conductor connection
n Workstation power line voltage connection, including monitor(s) on a separate socket

3.5.3 External indicator for X-ray or door contact


Construction measures can be performed if desired for the following options. See also
( System Connections / Page 47)
n External radiation indicator
n Radiation blocking by a door contact

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42 3 Preparation for Installation

3.5.4 Example for on-site Power Distributor (1-phase, 2-phase) according to


DIN VDE 0100-710 or National Regulations, and taking into account the
use of SIRIUS
Tab. 1 Line power information for Mammomat Fusion, permanently connected stand

Line power: TN-S 1(2)/N/GND, AC 50/60 Hz, ± 1Hz Connection 7.5 kVA
rating:
Stand connection volt‐ 1~ (1P/N/GND) 208, 220, 230, 240 V or Power con‐
age: 2~ (2P/N/GND) 208, 220, 230, 240, 400 sumption: Value
V n Continuous: n 0.5
Internal line resistance ≤ 300 mΩ
n Short-term kVA
n 7.5
Power distributor fuse 25A slow blow kVA
rating:
Min/max cable cross 2.5 mm2 / 4 mm2
section:
Do not connect any external power equipment to the line power supply.
Electrical installation according to IEC 60364-7-710, follow national and regional regulations.

Tab. 2 Line power information for workstation and monitors, removable power connection

Line power: TN-S 1/N/GND, AC 50/60 Hz, ± 1Hz


Connection voltage for 100 - 120 V, or
workstation and moni‐ 200 - 240 V
tors
Power distributor fuse Standard line power connection, 16 A slow blow
rating:
Do not connect any external power equipment to the line power supply.
Electrical installation according to IEC 60364-7-710, follow national and re‐
gional regulations.

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Fig. 21: 1-phase electrical installation

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Fig. 22: 2-phase electrical installation

Tab. 3 Legend / on-site interfaces to system

Position Designation
P1 Stand (Mammo Unit) line power connection
ND Power distributor, on-site
RD Control cable
EAT On/Off switch with indicator light
AT Emergency shutdown switch with mechanical locking mechanism, to
de-energize

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Preparation for Installation 3 45

Position Designation
5 For the workstation (WH AWS), a separate electrical outlet (AC 230 V or
country-specific) is required within 2 m from where it is positioned.
Note: To maintain the local legal safety measures or if the spacing from
the control console to the MammoUnit is less than 1.5 m, route a po‐
tential equalization cable from the control console to the MammoUnit
(P1). At a distance of greater than 1.5 m, this potential equalization ca‐
ble is recommended.
6 A 2nd socket within 3 m of the stand should be provided for the Mood‐
Light option. The MoodLight itself does not have an off switch. A socket
that can be switched off is recommended.

Tab. 4 Legend / on-site components

Position Designation
1 Potential equalization (protective conductor) to the stand has to be pro‐
vided on-site
2 Power cable, 2 mm2 / 4 mm2, obtained on-site
3 RCD ground fault circuit interrupter 25 A / 30 mA Type B, VN = 400/415
V~
4 Fuse according to national regulations
5 K2 master relay
6 SITOP voltage transformer from AC 230-500 V to DC 24 V
7 Sirius safety relay
8 Control relay

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46 3 Preparation for Installation

3.6 Siemens Remote Services (SRS)


Perform the technical preparations and measures to start up Siemens Remote Service for
Mammomat Fusion.
including
n IT link to install a broadband DSL/VPN connection to the Siemens Remote Service in‐
frastructure
Detailed information on SIEMENS Remote ServicesTM (SRS) can be found in the PG
TDIT-000.891.01.xx.02
n Complete the site-specific data according to the SRS checklist in the SRS tool kit and
send to the SRS-final team.
In addition to fast reaction times in service situations, Siemens Remote Service supports
special services such as Remote Update Handling, Virus Protection, and more.

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System Connections 4 47

4.1 General information on wiring

4.1.1 Power Line Voltage and Ground Wire Connections


n The stand is hardwired to the local power line voltage. The stand has to be able to be
de-energized through an emergency off switch in the examination room.
n Connect the control console (triple power strip), including the workstation and moni‐
tor(s), to the local line power socket.
 Only system-internal loads can be connected to these sockets. External devices
may not be connected here.
n It is recommended to connect the stand to the control console using a 6 mm2 poten‐
tial equalization cable (provided on site).

4.1.2 Signal and Data Cables


n The following controls and data lines are delivered with the system:
- MammoUnit control line (Ethernet cable)
- Detector control line (Ethernet)
- MammoUnit / control console control line
n Hospital IT network connection is provided on site, with connection to the workstation
n Optionally, potential-free signals of system status (X-ray, door contact) can be picked
up by the stand's CBS assembly.

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48 4 System Connections

4.2 Wiring diagram - fixed points

4.2.1 Definition of fixed points


Fig. 23: Fixpoint List

Tab. 5 Component fixed points

Fixed point Component Type of fixed point


P1 Mammomat Fusion Floor fixed point
P1a Control console with radiation shield Floor fixed point
PC Power distributor box Wall fixed point

Component
A Power distributor box (on-site)
B Power On/Off switch (*1)
C Mammomat Fusion
D Control console with radiation shield and control box
E Lamp for external radiation display (optional)

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System Connections 4 49

F "Radiation off" door contact (optional)


G Acquisition Workstation (WH AWS) and monitor(s) (*2)

*1 The power On/Off switch (EAT) should be near the P1a/control console fixed point so that the
operating personnel can de-energize the entire system.
*2 For a monitor to be installed on the left side of the operating console, a longer DVI cable (3 m)
must be provided.
If necessary, the 3 m DVI cable can be ordered using item no. 8677028.

4.2.2 Distances between fixed points


Tab. 6 Fixed Point List

Wir‐ of to Conduit, Min. Max. fixed Remarks


ing Fixed Fixed point Clear opening point dis‐
Har‐ point space [mm] tance
ness [m]
No. [inch]

Power cable to be ob‐


tained on site, cross
1 PC P1 -- -- -- section 6 mm2 rigid ca‐
ble or 4 mm2 flexible
cable
Control console cable
2 P1 P1a 3/4 ∅ 45 6,5
Shipped length: 10 m
Ethernet cable
3 P1 P1a 2 ∅ 45 7
Shipped length: 10 m
- on site Ethernet cable
Hospital
2 ∅ 45 with re‐
- IT network outlet
strictions
4 P1a
within 2 m for power line voltage
Power line voltage of the con‐ to the workstation and
2 ∅ 45
socket trol con‐ monitors
sole

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50 4 System Connections

Wir‐ of to Conduit, Min. Max. fixed Remarks


ing Fixed Fixed point Clear opening point dis‐
Har‐ point space [mm] tance
ness [m]
No. [inch]

External "radia‐ on site Optionally, potential-


5 P1 tion", "X-ray" signal 1/2 ∅ 10 with re‐ free "X-ray" or "door
processing strictions contact" signals can be
picked up at P1 and
used for external dis‐
play;
External "door con‐ on site
6 P1 tact" signal pro‐ 1/2 ∅ 10 with re‐ one control cable each
cessing strictions is required, 2x1.5 mm2,
shielded, provided on-
site
7 Potential equalization
P1 P1a -- -- 7 cable, minimum 6
mm2, provided on site

*1 Optional, to maintain the local safety measures or if the spacing from the control console to the
MammoUnit is less than 1.5 m, route a potential equalization cable from the control console
(including the workstation) to the MammoUnit (P1).
A potential equalization cable with connection loop (cable lug d = 6 mm) is recommen‐
ded.

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System Connections 4 51

4.3 Cable Inlets


Cable inlets are located
n on the back of the stand (MammoUnit)
Fig. 24: Stand cable inlet

n on the sides and at the bottom of the control console


Fig. 25: Control console, cable inlets to the right and left, as well as at the bottom

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52 4 System Connections

4.4 Cable Conduits and Cable Ducts - Minimum Size


Proposal for Cable Routing
n Depth of cable duct 60 mm
n It may be necessary to provide for greater duct depth for cross-overs.
n Route power cables separately from control cables (provide shielding where possible)
The following points must be taken into consideration:
n Avoid cable ring formations and intersections.
n Lay in separate conduits or closed cable ducts
n Lay in open cable channels, lay cables separately using metal dividers or a similar de‐
vice.
Fig. 26: Cable duct

(1) Metal dividers


(2) Cable duct

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Technical Data 5 53

5.1 Dimensions and Weights, Heat Dissipation

5.1.1 Dimensions and Weights


Tab. 7 Dimensions and Weights

Component Dimensions (WxDxH) Weight


[mm] [kg]
Stand with floor plate and generator ( Stand Dimensions and
350
Center of Gravity / Page 22)
Control console with radiation shield ( Control console with ra‐
diation shield dimen‐ 130
sions / Page 24)
Workstation (WH AWS) ( Acquisition Workstation
26
Dimensions / Page 25)
Control box ( Control box dimen‐
1
sions / Page 26)
Wall holder (optional) 1180 x 80 x 40 --
19" color display 404 x 205 x 406-506 6,9
21" color display 368 x 209 x 516-598
9,2
(Portrait format)

5.1.2 Heat dissipation


Tab. 8 Heat dissipation

Component Heat Dissipation [W]


Stand with floor plate and generator 500
Control console with radiation shield --
Workstation (WH AWS) –
Control box 10
18" black/white display 65
19" color display 50
21" color display 110

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54 5 Technical Data

5.2 Climatic Conditions

5.2.1 Temperature, Relative Humidity and Barometric Pressure


Tab. 9 System Environmental Conditions during Operation

System During operation


Recommended ambient temperature *1) +20 ... +35˚ C
Relative humidity (non-condensing) 30 ... 75 %
Permissible Barometric Pressure 70 ... 106 kPa
Max. temperature gradient 10 K/h

(*1) The detector temperature during operation is approx. 3 - 5˚ C above the ambient
temperature.
The permissible detector temperature must be taken into consideration, see
( Tab. 10 Page 54).

Tab. 10 Detector Environmental Conditions during Operation

Detector During operation


Relative humidity (non-condensing) 10 ... 90%
Permissible Barometric Pressure 70 ... 106 kPa
Max. temperature gradient 10 K/h

NOTICE
The detector is calibrated manually in periodic intervals.
Based on this calibration, a working range of ± 7˚ C is available.
Optimum image quality outside of this working range without re-calibration is not
ensured.
 To ensure constant and optimal image quality, environmental conditions
must be maintained absolutely. Avoid direct sunlight!

For climatic conditions for storage and transport, see ( Climatic Conditions / Page 58).

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Technical Data 5 55

If the primary power source of the system is turned off via a fuse switch in the technical
installation, the detector needs additional time to warm up.

 Additional time for system release for


n Detector calibration
n Clinical exposures

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56 5 Technical Data

5.3 Electrical Data

5.3.1 MammoUnit
Tab. 11 Electrical Specifications

Power connection 1~ (1P/N/PE) 208, 220, 230, 240V ± 10 %, 50/60 Hz or


2~ (2P/N/PE) 208, 220, 230, 240, 400 V ±10 % 50/60 Hz
Input fusing: 25 A
Power cable Recommended cable cross section:
6 mm² rigid cable
4 mm² flexible cable
Internal line impedance UN [V] Rimax [Ω]
Ri 208 0,25
220 0,28
230 0,30
240 0,35
400 0,90
Fusing (internal) 25 A for 208, 220, 230, 240, and 400 V
Imax 40 A for 230 V, 35 A for 400 V (2-phase)
Power Consumption Short-term power consumption Continuous load approx. 0.5
approx. 7.5 kVA kVA
Power factor (cos ϕ) 0.6 at 230 V
Connection value 7.5 kVA at 230 V

5.3.2 Workstation and Monitor


Tab. 12 Workstation and monitor electrical data

Component Power connection values


Workstations 100 - .127 V, +/9.5 A / 50/-60 Hz or
for M470-1, M470-2 or M720 200...240 V, 4.0 A, 50-60 Hz
19” standard monitor 100…120 V, 0.80 A, 50/60 Hz or
200…240 V, 0.45 A, 50/60 Hz
3 MP monitor 100…120 V, 1.4…1.1 A, 50/60 Hz or
200…240 V, 0.7…0.6 A, 50/60 Hz

Mammomat Fusion XPW7-388.891.01.06.02 Page 56 of 62 © Siemens, 2013


09.15 CS SD XP WH&SG Restricted
Technical Data 5 57

5.4 Paint Information


Tab. 13 Paint Colors

Base color, surface Signal white, RAL 9003


Stripes, sides White aluminum, RAL 9006

© Siemens, 2013 XPW7-388.891.01.06.02 Page 57 of 62 Mammomat Fusion


Restricted 09.15 CS SD XP WH&SG
58 6 Transport and Storage Conditions

6.1 Climatic Conditions


Tab. 14 Environmental conditions for transport, system

System Transport / Storage


Ambient temperature -20 ... + 70˚C
Relative humidity (non-condensing) 10 ... 90%
Permissible Barometric Pressure 70 ... 106 kPa
Max. temperature gradient 10 K/h

Tab. 15 Environmental conditions for transport, workstation

Workstation Transport / Storage


Permissible ambient temperature –40 ... + 70˚C
Relative humidity (non-condensing) 5 - 60%
Permissible Barometric Pressure 70 ... 106 kPa
Max. temperature gradient 10 K/h

Tab. 16 Environmental conditions for transport, detector

Detector Transport / Storage


Permissible ambient and detector temperature – 20 ... + 70˚C
Relative humidity (non-condensing) 10 - 90%
Permissible Barometric Pressure 70 ... 106 kPa
Max. temperature gradient 10 K/h

Mammomat Fusion XPW7-388.891.01.06.02 Page 58 of 62 © Siemens, 2013


09.15 CS SD XP WH&SG Restricted
Transport and Storage Conditions 6 59

6.2 Transport Dimensions and Weights


Tab. 17 Transport Dimensions and Weights

Largest crate Dimensions Weight


LxWxH [mm] [kg]
Stand, including generator and detector 2260 x 930 x 1550 550
Radiation shield, workstation, and accessories 2100 x 800 x 1320 220 - 300 (*1)
Additional information:
Stand, without packaging and lifting carriage 1930 x 780 x 1175 530

*1 depends on the options ordered

© Siemens, 2013 XPW7-388.891.01.06.02 Page 59 of 62 Mammomat Fusion


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60 7 Changes to Previous Version

Version <05> compared to Version <04>

Capter Changes
Installation Preparations The following sections have been changed:
n The measurements for the anchor points have been pro‐
vided.
( Control console - information regarding floor anchor‐
ing / Page 37)

Mammomat Fusion XPW7-388.891.01.06.02 Page 60 of 62 © Siemens, 2013


09.15 CS SD XP WH&SG Restricted
List of Hazard IDs 8 61

The list shows the Hazard IDs of this document.


n hm_DOC_F14G3U1M4 04H393925
-System insufficiently cooled off (Page 6)
n hm_DOC_F17G2U4M1 04H394682
-Incorrect service or maintenance of the Mammomat, including its options, can
cause serious bodily injury. (Page 5)
n hm_DOC_F4G1U1M11 04H392736
-Insufficient distance between moving parts and fixed structures in the room
(Page 7)
n hm_DOC_F8G2U1M4 04H393531
-Software virus attack (Page 7)
n hm_DOC_F4G1U21M1 04H392814 / hm_DOC_F4G1U21M2 04H392815
-Unintended movement because system fails to stop moving during an emergency.
(Page 6)
n hm_DOC_F4G1U1M10 04H392735
-Insufficient distance between moving parts and fixed structures in the room
(Page 7)
n hm_DOC_F14G5U1M2 04H394032
-Danger of tipping over. (Page 6)
n hm_DOC_F14G8U4M1 04H394112
-The occurrence of static electricity in the examination room can cause injury or
damage to system components if the Mammomat Fusion is touched. (Page 6)
n hm_DOC_F4G1U1M2 04H392727/ hm_DOC_F4G1U1M3 04H392728 /
hm_DOC_F4G1U1M8 04H392733
- Patient or machine operator crushed (Page 7)

© Siemens, 2013 XPW7-388.891.01.06.02 Page 61 of 62 Mammomat Fusion


Restricted 09.15 CS SD XP WH&SG
- Restricted - All documents may
only be used by authorized person‐
nel for rendering services on Sie‐
mens Healthcare Products. Any
document in electronic form may
be printed once. Copy and distribu‐
tion of electronic documents and
hardcopies is prohibited. Offenders
will be liable for damages. All other
rights are reserved.

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Print No.: XPW7-388.891.01.06.02 | Replaces: XPW7-388.891.01.05.02


Doc. Gen. Date: 09.15 | Language: English
© Siemens Healthcare GmbH, 2013

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