System Owner Manual

System Owner Manual
MAGNETOM Aera
Print No. M7-01002G.629.16.02.02

© Siemens Healthcare GmbH, 2018
www.siemens.com/healthcare
Legal Manufacturer
Siemens Healthcare GmbH
Henkestr. 127
91052 Erlangen
Germany
Siemens Healthcare Headquarters
Henkestr. 127
91052 Erlangen
Germany
Phone: +49 9131 84-0
siemens.com/healthcare
Manufacturer’s note:
This device bears a CE mark in accordance with the provisions of Council
Directive 93/42/EEC of June 14, 1993 concerning medical devices and
the Council Directive 2011/65/EU of June 08, 2011 on the restriction of
the use of certain hazardous substances in electrical and electronic
equipment.
The CE marking applies only to medical devices which have been put on
the market according to the above-mentioned EC Directives.
Unauthorized changes to this product are not covered by the CE mark
and the related Declaration of Conformity.
Contents
Introduction 1
Safety Information 2
MR compatibility data sheet 3
Guidance and manufacturer’s declaration EMC 4
Technical data 5
Location of labels 6
Maintenance Plan 7
Disposal 8
Manufacturer Disclosure Statement for

9
Medical Device Security – MDS2 9
Product & Solution Security Whitepaper 10
Register A - J 11
System Owner Manual

Introduction
Dear customer,
On the occasion of inspections and controls by the authorities you must always have many different
documents at hand. The present System Owner Manual is intended to make archiving these documents
simpler for you so that you always have them completely at hand if necessary.
We have already filed the most important documents in the System Owner Manual on delivery of your
system.
The further updating of the Manual now lies in your hands.
We therefore recommend that you designate an employee right at the start-up of your new system who
will be responsible for continuously updating the System Owner Manual and who immediately has it at
hand as required.
Upon request, Siemens Service will provide technical documents for the MR system (e.g. circuit dia-
grams, spare parts lists, descriptions, calibration instructions, component part lists). However, this does
not constitute authorization for repairs.
! All labels displayed in the System Owner Manuals are examples only and may differ from the labels
attached to the system and the components.
We wish you much success with your Siemens system.
Siemens Healthcare
representative
System Owner
Manufacturer
Siemens
■
■
■
P.S.: The table on the following page shows which documents are filed in the System Owner Manual
and who contributes the documents.
Introduction – Page 1 of 4
Who supplies what? The documents in the System Owner Manual.
representative
System Owner
Manufacturer
Siemens
Document
1 Introduction
■ Notes on handling the System Owner Manual
■ Operator and location of the product
2 Safety information
■ Important safety aspects for the owner of a MR system
3 MR compatibility data sheet

■ Information for evaluating the MR compatibility of non-Siemens MR products
4 Guidance and manufacturer’s declaration EMC

■ Guidance and manufacturer’s declaration regarding electromagnetic compatibility
5 Technical data
■ Technical data
■ Upgrades and additions
6 Location of labels
■ Location of labels
7 Preventive maintenance
■ Maintenance plan
■ Maintenance contract
■ Maintenance certificates
8 Disposal
■ Instructions for disposal of problematic substances
9 Manufacturer Disclosure Statement for Medical Device Security – MDS2

■ Security information about the product
10 Product & Solution Security Whitepaper

■ Overview of product and solution security
11 Correspondence with authorities

■ Files according to country-specific regulations
12 Certificates
■ Installation certificate
■ System handover certificate
■ Customer instruction certificate
■ Constancy test certificate
13 Software licenses and warranty

■ Software licenses including software warranty conditions
Who supplies what? The documents in the System Owner Manual.
representative
System Owner
Manufacturer
Siemens
Document
14 Updates
■ Performed updates
15 Room layout
■ Practice and room drawings
16 Revision level of components

■ List of the delivered components including hardware and software level
■ Revision levels after component replacements
17 Declaration of conformity
Series certification of the entire system with all possible options.
Your Siemens service technician will find the appropriate conformity declaration under the following
address:
https://intranet.medical.siemens.com/Sales+Intranet+International/Divisions/Magnetic+Resonance/
CrossProductInformation/?languagecode=de
Select the “Certificates & Declarations” link under the “Regulatory” section of “Cross Product Informa-
tion”.
Information about branding
Siemens Healthineers
Siemens has recently reorganized its organizational group structure. The healthcare business now is a
separate legal entity. This is manifested in our new brand name:
While we have adopted this new brand name, the legal name of our company and the name of the
Legal Manufacturer do not change. This change also does not impact any legal obligations. This new
brand name is reflected on newly created product labeling (for example, user and technical manuals).
Already existing material will not bear the new brand name.
MAGNETOM Family
System Owner Manual – Safety Information
syngo MR E11
Table of contents
1 Safety information for the system owner 5

1.1 Preamble 5
1.1.1 Common causes for accidents 5
1.1.2 Responsibility 5
1.1.3 Definitions of different persons 5
1.2 Legal regulations 6
1.2.1 Country-specific regulations 6
1.2.2 National guidelines (for Germany) 6
1.2.3 Pressure Equipment Directive 6
1.2.4 Electromagnetic fields 6
1.2.5 Noise development 7
1.2.6 Laser 7
1.2.7 Video monitoring 7
1.2.8 Combination of devices 7
1.2.9 Installation 8
1.3 Emergency plans 8
1.3.1 Access to the examination room 8
1.3.2 Emergency procedures 9
1.3.3 Quench emergency plan 9
1.3.4 Fire fighting 10
1.4 Employee qualifications/information 11
1.4.1 Informing MR workers 11
1.5 Pre-screening MR workers and patients 13
1.6 Examination room and ambient conditions 14
1.6.1 Explosion protection 14
1.6.2 Emergency switches 14
1.6.3 Air conditioning 14
1.6.4 Magnetic fringe field and controlled access area 14
1.7 Signs and symbols 14
1.7.1 Overview table 15
1.7.2 Protective class symbols 15
1.7.3 Shock indicator 16
1.8 Maintenance/repair 16
1.8.1 Responsibility 16
1.8.2 Maintenance at regular intervals 16
1.8.3 Repairs and modifications 17
1.8.4 Refilling helium 17
Index 19
MAGNETOM Family | syngo MR E11 3

Print No. MR-04009G.623.33.02.02
Table of contents
4 Safety Information | System Owner Manual

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Safety information for the system owner 1
1 Safety information for the

system owner
1.1 Preamble
This section of the system owner manual contains the most important safety
aspects for which you, as the owner of the MR system, will be responsible.
These include legal requirements, emergency plans, employee information and
qualifications, as well as requirements that must be met in the examination
room.
1.1.1 Common causes for accidents

Of particular importance is the obligation to inform employees and contractors.
Operating personnel as well as personnel who are not regulars in the
examination room (e.g. cleaning personnel, rescue personnel) must be
informed about the special conditions in the examination room. Magnetizable
devices (e.g. floor polishers, vacuum cleaners, wheelchairs, metal gurneys)
must not be used in the examination room.
◆ Please note all safety instructions applicable to all users which are described
in the operator manual of the system. See: Operator manual MR system
1.1.2 Responsibility
Siemens accepts no responsibility for the safety, reliability, and performance of
the MR system, if the MR system is not used in accordance with the instructions
for use (Operator Manual, System Owner Manual). Siemens is also not
responsible for any direct or indirect damages caused by incorrect operation.
This includes, but is not limited to, accidents with ferromagnetic objects. This
applies even if the consequences only become obvious at a later point in time.
1.1.3 Definitions of different persons
Term used Explanation
User/Operator/ Person who operates the system or software, takes care

Operating per- of the patient or reads images
sonnel
Typically physicians, trained radiological technicians, or
technologists
System owner Person who is responsible for the MR environment. This

includes legal requirements, emergency plans, employee
information and qualifications, as well as maintenance/
repair.
MR worker Person who works within the controlled access area or

MR environment
User/Operator as well as further personnel (for example,
cleaning staff, facility manager, service personnel)

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1 Safety information for the system owner
Term used Explanation
Siemens Service/ Group of specially trained persons who are authorized by

service personnel Siemens to perform certain maintenance activities
References to “Siemens Service” include service personnel
authorized by Siemens.
1.2 Legal regulations
1.2.1 Country-specific regulations

Local and national legal regulations must be observed. It is the operator’s
responsibility to follow local statutory requirements regarding access to the
controlled access area.
The local regulations also define the acceptable exposure limits regarding noise
as well as magnetic stray fields for users and patients. See: System Owner
Manual: Technical data
If required, the RF source must be registered with local authorities in accordance
with national EMC guidelines.
1.2.2 National guidelines (for Germany)

The following regulations are in effect in Germany:
◾ Medical Devices Act (MPG)
◾ Electromagnetic Device Compatibility Act (EMVG)
◾ Medical Device Operator Regulations (MPBetreibV)
◾ Accident Prevention Regulations (UVV)
◾ Regulation on worker protection against electro-magnetic fields, based on the
DIRECTIVE 2013/35/EU (EMF Directive)
1.2.3 Pressure Equipment Directive

The super-conductive magnet is classified as pressure equipment. National
guidelines for starting up and operating pressure equipment must be observed.
In Europe, the Pressure Equipment Directive (97/23/EG) regulates the sale of
pressure devices.
In Germany both the Pressure Equipment Directive as well as the relevant
Occupational Safety Regulations (BetrSichV) for system start-up and operation
apply.
1.2.4 Electromagnetic fields

The 0.5 mT line in the examination room defines the controlled access area of
the static magnetic field. For controlling access to this area adequate rules must
be established. The potential risks from the attraction of magnetizable objects
or from torque on such materials must also be considered. The possibility must
be addressed that persons with medical implants, such as pacemakers, could
enter the area without realizing that the medical implants may be adversely
affected by the field.

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Outside the controlled access area, electromagnetic interferences meet the

requirements according to IEC 60601-1-2.
Regarding the static magnetic field, your MR system is continuously operated in
the normal mode. Normal mode ranges up to 3T and the first level mode up to
8T. For China only: If the static magnetic field is higher than 2T, the system is
continuously operated in the first level mode.
The limits of exposure of MR workers to static and time-varying magnetic fields
may be regulated by local laws. Special precautions are necessary for pregnant
MR workers, although no epidemiological evidence of any negative health
effects currently exists (local laws may apply). It might be that the limits do not
apply for pregnant MR workers. Additionally some countries may require a
“member of the public” limit for pregnant MR workers, as the fetus is assigned
as a member of the public.
1.2.5 Noise development

The exposure of MR workers to noise may be regulated by local laws. The
system owner must ensure that the sound level at the operating console is
limited in compliance with local rules for the safety of the physician and the MR
worker.
1.2.6 Laser
The laser of the laser light localizer is classified as Class 2M according to IEC
60825-1 (Class II according to US CDRH).
1.2.7 Video monitoring

Labeling obligation may be regulated by local laws. If a video system is installed
and labeling requirements apply, the system owner is responsible to comply
with these laws and has to install the required labels.
1.2.8 Combination of devices
 WARNING
Third-party devices connected to the MR system!

Several failures possible from electrical hazards, from RF burns to
worsening of image quality
◆ Ensure that any combination with or modifications to the system
comply with the requirements of IEC 60601-1 (chapter 16) and are
accepted by Siemens.
Any application of physiological monitoring and sensing devices to the patient is

done under the exclusive direction and responsibility of the system owner.
To perform a general test of the correct operation of peripheral equipment, a
compatibility protocol is available. Manufacturers of peripheral equipment
should use this Siemens compatibility protocol to test the functionality of its
equipment. See: System Owner Manual: Compatibility data sheet

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1.2.9 Installation
 WARNING
Overload of circuit; water ingress; insufficient disconnection from the

mains
System malfunction; risk of electric shock
◆ Do not connect further components, which are not part of the original
delivery volume, to the multiple socket of the computers.
◆ Do not connect further multiple sockets to the system.
◆ Ensure that the multiple socket of the computers is not placed on the
floor.
◆ Do not use an isolating transformer.
 WARNING
Risk of electric shock

◆ To avoid the risk of electric shock, this equipment must only be
connected to a supply mains with protective earth.
1.3 Emergency plans

Specific provisions must be taken for possible emergencies. This includes the
generation of emergency plans (instructions on how to proceed/rescue
scenarios) to prevent incorrect behavior under special circumstances.
1.3.1 Access to the examination room

Escape routes for the building must be established and well marked. Escape
routes must not be obstructed.
1 Ensure that you have tools available to break the door open in case of an
emergency.
2 Ensure that a window in the examination room can be used as an escape
route in the case of an emergency.
 WARNING
RF door does not function as required!

It is not possible to freely access or leave the examination room in
case of an emergency
◆ Ensure that the RF door is checked and maintained regularly.
◆ Establish instructions on how to proceed in emergency situations. To
avoid a situation where the patient is not accessible because the door
cannot be opened (for example, the door handle becomes defective)
establish alternative means/measures to enable the door to be
opened quickly.

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1.3.2 Emergency procedures

Instructions on how to proceed in emergency situations must be defined to
ensure the safety of patients. For this purpose, MR-specific risks must be
included (for example, the presence of a magnetic field).
Among other things, the instructions must establish the fastest possible way for
removing patients in emergency cases from the magnet’s influence (if necessary
by shutting down the magnet). The instructions should also establish measures
to ensure medical care as soon as possible.
Especially endangered patients and As special precautionary measures, a program for medical supervision as well as
MR workers a plan for using emergency equipment outside the magnet’s influence must be
in place for patients with a higher than normal risk factor, such as:
◾ Patients susceptible to cardiovascular collapse
◾ Patients who are likely to develop seizures
◾ Patients who are at an increased risk of heart attacks or other cardiac
problems
◾ Patients with limited thermoregulation
◾ Claustrophobic patients
◾ Patients who are unconscious, anesthetized or confused or who are not able
to communicate normally for other reasons
◾ Children
MR scanning is not established for safe imaging of fetuses and infants
 under two years of age. The responsible physician must evaluate the
benefits of the MR examination compared to those of other imaging
procedures.
1.3.3 Quench emergency plan
 WARNING
Emergency situation with magnet quench!

Danger to life due to asphyxiation and hypothermia induced within a
very short time
◆ Establish instructions on how to proceed in case gaseous helium
escaping into the examination room.
The emergency plan should include the following information:

◾ Rescue scenarios that can be practiced with personnel
◾ Room-related conditions
◾ Rescue personnel (safety personnel, paramedics and firemen)
◾ Magnet Stop switch

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Quench During a quench, the super-conductivity of the magnet is lost. The energy of the
magnetic field is converted into heat and the magnet field strength falls off. The
liquid helium (coolant) boils off rapidly during this process and is released to the
outside via the exhaust vent line. The escape of gaseous helium via the exhaust
line is very noisy due to the high gas flow and you can hear a loud roaring noise
for several minutes.
A quench may occur as follows:
◾ Start-up of the MR system (ramping up or filling the magnet)
◾ An accident (earthquake, fire, etc.)
◾ Spontaneously without any obvious external reason (highly unusual)
Defective vent line If the vent line fails in part or fully, gaseous helium will enter the examination
room. In this case the air conditioning unit will not be able to ensure sufficient
air exchange and the following hazardous situations may arise:
◾ Poor visibility due to strong fog in the upper area of the room
◾ Rise in pressure in the examination room
◾ Hypothermia and risk of suffocation (e.g. in case of large leaks)
Due to such hazardous conditions as acute hypothermia and suffocation,

rescue attempts must not be performed by a single person.
Persons not directly involved in the rescue should leave the examination
 room as well as adjacent rooms.

A filter (gas mask) without its own oxygen supply does not protect against
suffocation through helium.
An emergency plan must be established to ensure correct conduct under
such hazardous conditions.
1.3.4 Fire fighting

In the event of fire, the fire has to be extinguished with methods appropriate to
the surroundings. Respective fire fighting equipment must be available. Fire
precautions should be discussed with the local fire department and emergency
procedures should be established. It is in the operator's responsibility to take the
necessary initiatives.
 Only use fire extinguishers licensed for MR systems.
Mandatory reporting in case of fire 1 Prior to initial start-up of the MR system, ensure that the fire department is
informed about the MR system as well as structural on-site conditions.
2 Inform the fire department about the contents of the measurement
phantoms and the health risks caused by nickelous aerosol formations.

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1.4 Employee qualifications/information

MR workers are individuals (e.g. operator, further personnel) who work within
the controlled access area or MR environment. The system owner is responsible
for ensuring that only trained and qualified MR workers and physicians are
working on the MR system, so that they can perform all their tasks safely and
efficiently, and in a way that minimizes their exposure to the electromagnetic
field. In addition, the MR system may only be used as intended.
The system includes a key switch to prevent unauthorized switch on.
1.4.1 Informing MR workers

MR personnel must read and understand the operator manual, paying special
attention to the safety chapter, before working with the MR system. The safety
hints regarding the magnetic fields must also apply to MR workers. An
understanding of MR safety is especially important for those individuals who
only work in the MR environment occasionally. For further information, see:
Operator manual MR system.
The personnel must pay special attention to the following aspects:
◾ Effects of the magnetic field, see: Operator Manual MR System:
Electromagnetic fields
– Effects on electronic and/or electrically conductive implants
– Possible effects on pregnant MR workers (local laws may apply)
– Possible side effects of 3T magnetic fields like dizziness, vertigo, and
metallic taste, especially when moving the head rapidly inside or close to
the MR equipment; these effects can be avoided or minimized by reducing
speed of motion (for example, slow movements of the head or table).
◾ Safety aspects of the MR Conditional tools and accessories used, with respect
to the static magnetic field B0
◾ Hearing protection:
– Provide the patient with appropriate hearing protection that lowers noise
to at least 99 dB(A).
– It is mandatory to provide anesthetized or unconscious patients with
hearing protection. Ear protection for these patients should not be omitted
even at moderate sound levels.
– Ensure that personnel and accompanying persons in the examination room
wear hearing protection during the examination to lower noise to at least
85 dB(A).
For required level of hearing protection, see: Technical data: Hearing
protection data. All hearing protection devices must provide the required
level of sound attenuation.
– For appropriate sound attenuation, the proper use of hearing protection is
important. All personnel should be trained to correctly apply the hearing
protection.
– Special attention and training of the operator is required for proper
positioning of the hearing protection for neonates and infants. In addition
this applies to any other condition where an alternative form of hearing
protection might be necessary.
– For MR examinations of infants special hearing protection may be required.

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The operator should be particularly aware of:

◾ Adherence to the positioning information for patients (to avoid current loops
and burns)
◾ Careful input of the patient weight/position and orientation
◾ Possible peripheral nerve stimulation, as effect of the First level controlled
operating mode on patients and MR workers
 WARNING
MR workers and all personnel who have access to the MR system are not
sufficiently informed!
Personal injury, property damage
◆ Ensure that all personnel (incl. cleaning crews, rescue personnel, etc.)
are regularly informed about the potential risks inherent in MR systems
as well as the relevant safety information (for example, regarding
magnetic forces).
◆ The exclusion zone and corresponding safety measures must be
observed even when the system is switched off.
Training MR workers and physicians Personnel and physicians must be trained in the safe and effective use of MR
systems. The training must include the following topics:
◾ Emergency medical care
◾ Controlled access area
◾ Emergency switches
◾ Measures preventing fires
◾ Quench emergency plan
◾ Prevention of hazards related to magnet forces
◾ Combinations with other devices
The physician must complete a special training course on interpreting images.
 WARNING
Untrained or uninformed personnel!

Injury of persons
Damage to measurement phantoms
Fire hazard due to lens effect
◆ Train all personnel who have access to the MR system (incl. cleaning
crews, rescue personnel, etc.).
◆ Inform these people with respect to the hazards and protective
measures to be used when handling measurement phantoms.
◆ Ensure that the training includes the topic on “Handling leaks occurring
with measurement phantoms ” as well as “Handling and storing
measurement phantoms”.

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 WARNING
Magnetizable objects introduced into the magnetic field become

projectiles!
Injury to patient and operating personnel
◆ Inform the operating personnel about the effect of forces on
ferromagnetic parts or implants, especially on systems with a high field
strength. Explain that the forces increase with the field strength of the
magnet!
1.5 Pre-screening MR workers and patients

To lower the risks during exposure to the magnetic field, all patients as well as
MR workers have to accomplish a pre-screening to avoid accidents and to
establish safety measures. Therefore a pre-screening program shall be
established by the operator, which helps the user to identify the patients and
MR workers at risk. This especially applies to patients and MR workers who are
at risk due to their professional activities, medical history and medical state as
well as the influence of the MR equipment, such as:
◾ Patients and MR workers:
– with implants or with permanent make-up
– with imbedded metal fragments from military activities
– who are pregnant
◾ Patients:
– with typical contraindications, see: Operator Manual MR system:
Contraindications
– with a higher than normal likelihood of needing emergency medical
treatment: in general and also in the First Level Controlled Operating Mode
 WARNING
Scanning of patients with MR Conditional implants!

Spatial gradients may affect or even destroy the implant; injury to the
patient
◆ The patient will be exposed to high spatial gradients when moved into
the bore. Always check the spatial distribution diagrams included in the
System Owner Manual.
There are no risks regarding materials or ingredients to which the patient or

user is exposed. They are all checked for biocompatibility.

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1.6 Examination room and ambient conditions
1.6.1 Explosion protection

Your system is not intended for operation in areas prone to explosive anesthetic
gases.
1.6.2 Emergency switches

The voltage to the MR system can be turned off via a Power-Off (Emergency
Shut-down) switch installed on-site. The switch can be used to switch off the
electric power of the entire system immediately. The room installation must
correspond to VDE 0100-710 and/or national laws.
A quench can be released with the Magnet Stop switch. This switch is installed
on-site as well.
1.6.3 Air conditioning

An air conditioning system must be used to ensure the required environmental
conditions. See: Technical data
The air conditioning is installed on-site by the system owner. It is not part of
 the MR system. Information with respect to maintenance (e.g. replacing

filters) and monitoring the functions of the air conditioning are included in
the operating instructions of the air conditioning manufacturer.
The functions of the air conditioning or the temperature and relative humidity
of the examination room must be checked at regular intervals.
( Page 16 Maintenance at regular intervals)
1.6.4 Magnetic fringe field and controlled access area

The fringe field can affect devices in the vicinity of the magnet. For this reason,
the required safety distances must be observed. For details, please refer to the
MR compatibility datasheet. See: System Owner Manual: MR compatibility
datasheet
1.7 Signs and symbols

The system owner is responsible for properly identifying the accessible areas
(for example, regarding the electromagnetic field), the vicinity of the MR
system, as well as adjacent areas by using the appropriate signs.

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 WARNING
Missing hazard labels!

◆ Attach the required warning and prohibition signs and observe national
guidelines.
◆ Mark critical system areas with warning and prohibition symbols.
◆ Ensure that warning and prohibition signs are legible and clearly visible.
1.7.1 Overview table

The following table of warning and prohibition signs must be installed in a
clearly visible location at eye level, preferably at the door to the examination
room. Depending on the system, the field strength is also shown (for example,
1.5T or 3T).
Regarding MR compatibility (MR Safe, MR Unsafe, MR Compatible ...), please

refer to the safety section in the Operator Manual MR System.
1.7.2 Protective class symbols

Protection class B represents protection against electrical shock with special
emphasize on leakage currents. For further information, see “signs and symbols”
in the MR System Operator Manual.
The protective class symbol Type B/BF for application parts is located, e.g., at the
patient table, the components for the physiological measurement unit, and at
the RF coils.

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1.7.3 Shock indicator

Shock indicators for monitoring the transport are affixed to the packaging and
to sensitive components, for example, RF coils. The red color inside the glass
tube (activated shock indicator) signals that the respective component was not
handled with the required care.
However, an activated shock indicator does not necessarily indicate damage to
the respective component. When the shock indicator has been activated, the
respective component must undergo functionality testing prior to actual use.
RF coils are subject to quality measurements.
1.8 Maintenance/repair
1.8.1 Responsibility
As a supplier, Siemens will not be held responsible for the safety, reliability, and
performance of the system in the following cases:
◾ Installations, additions, adjustments, modifications, and repairs to the MR
system, or changes to the software that are not performed by Siemens
Service.
◾ Assemblies are not replaced with original spare parts.
◾ The electrical wiring in the room does not meet the requirements of VDE
regulation 0100-710 or applicable national regulations.
Siemens is not responsible for potential damage in the event non-authorized
personnel refill the magnet with helium.
Modifications to the system or sub-systems during the service life require
evaluation to the requirements of IEC 60601-1.
 WARNING
Unauthorized work on the magnet!

◆ Only authorized personnel (Siemens Magnet Technology or Siemens)
may perform work on the magnet.
◆ Do not open or remove safety valves and burst disks of the helium
container.
◆ Do not change the standard configuration.
The monitors must only be opened by authorized Siemens Service personnel.
1.8.2 Maintenance at regular intervals

In the interest of the safety of patients, operating personnel, and third parties, it
is strongly recommended that only authorized personnel perform the
maintenance procedures provided by Siemens. System checks should be
conducted more frequently if the system is operated under extreme conditions.
For further information, see: System Owner Manual: Maintenance Plan.
◆ Please inform Siemens Service if a maintenance contract does not exist.

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Daily checks In the course of system operation, technical and constructional changes may
have been made to the MR system and its environment. It must be ensured that
all components function satisfactorily and that the changes do not present
hazardous conditions.
After system acceptance by the customer, a daily visual inspection should be
performed for the MR system with respect to the following constructional
changes:
◾ Changes in the environment at the output of the exhaust line (e.g. window
installed retrospectively, inlet and outlet of air-conditioning units, new
buildings or temporarily installed containers)
◾ Changes to the air conditioning unit or venting system (e.g. by adding air
inlets and outlets in neighboring rooms)
◾ Installation of additional MR systems (e.g. prohibited use of the same exhaust
line for several MR systems)
◾ Constructional changes inside and outside the examination room
The examination room must be checked for (newly introduced) magnetic parts.
Annual checks The annual technical safety inspections are listed in this system owner manual
and may only be performed by Siemens Service.
1.8.3 Repairs and modifications

All work, additions, and modifications to the MR system or to the installation
site must be checked by Siemens in advance to ensure their compatibility with
the MR system's functionality.
Modifications or additions to the product must comply with legal regulations.
The person performing the work must provide a certificate describing the nature
and extent of work performed. This certificate must include information about
changes to the nominal data or work area, along with the date, name of
company, and signature.

Upon request, Siemens Service will provide technical documents for the MR
system (e.g. circuit diagrams, spare parts lists, descriptions, calibration
instructions). However, this does not constitute authorization for repairs.
1.8.4 Refilling helium

The magnet is filled with liquid helium as a coolant. Following installation, it is
adjusted to the desired operating field strength.
During normal operation, the magnet does not lose helium. Under special
conditions - power failure, malfunctions of the cold head and maintenance
activities - liquid helium must be refilled by Siemens Service or specially
qualified personnel.
MAGNETOM Prismafit only: Liquid helium must be refilled at regular intervals by
Siemens Service.
When filling the magnet with helium, perform the necessary tasks carefully and
accurately, observing all regulations. Wear protective clothing to prevent
frostbite.

Print No. MR-04009G.623.33.02.02
Helium-related risks Liquid helium presents the following properties that, among other things, may
result in hazardous conditions when not handled professionally:
◾ Extremely cold: causes frostbites when it comes in touch with skin
◾ Oxygen in ambient air is displaced during boil-off: risk of asphyxiation
If the helium fill level is too low, the alarm box or the syngo Acquisition
Workplace will signal this accordingly.
◆ In case of alarm, notify Siemens Service and/or ensure refilling only through
trained and experienced personnel.
Storage
 It is prohibited to store flammable material in the vicinity of containers filled

with coolant.
◆ Use non-magnetic coolant containers for the helium.
 WARNING
Improper storing of coolant containers and escaping gaseous helium

during refill activities!
Injury to persons, danger of suffocation, frostbite
◆ Ensure that the rooms are ventilated via an air conditioning system.
This includes refilling with helium as well.
◆ Ensure that escape routes have been determined, are identified as
such and are not obstructed (e.g. by coolant containers).
◆ Ensure that the magnet is only filled by Siemens Service.

Print No. MR-04009G.623.33.02.02
Index
A Responsibility
Safety instructions 16
Accidents
Fire fighting 10
S
Air conditioning
Ambient conditions 14 Safety information
System owner 5
Ambient conditions
Air conditioning 14 Safety instructions
Quench 10
C Signs and symbols
Warning and prohibition signs 14
Coolant
Safety information 17
W
E Warning labels
Warning and prohibition signs 14
Electromagnetic fields
Magnetic fringe field 14
Emergency 9
Emergency plan
Establishing 9
Emergency plans
Procedural instructions 8
Rescue scenarios 8
F
Fire
Requirement of information 10
Fire|
Fire fighting 10
H
Hazards
Coolant 17
Laser 7
Helium
Hazards 18
Refilling 17
L
Laser light localizer
M
Maintenance
Safety information 16
Maintenance/repair 16
P
Product safety
Q
Quench
R
Repair

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Print No. MR-04009G.623.33.02.02
Print No. MR-04009G.623.33.02.02 | © Siemens Healthcare GmbH, 2018
MAGNETOM
MR
System Owner Manual
MR compatibility data sheet
Aera
2
MR compatibility
The data and protocols included in this manual provide the operator with the means for
evaluating the MR compatibility of non-Siemens MR products with the MR system
described in the System Owner Manual.
The MR compatibility of non-Siemens MR products addresses products of both manufactur-
ers, the company producing the non-Siemens MR product and the company producing the
MR system. The operator is ensured the safe operation of the non-Siemens MR product
together with the MR system only when both manufacturers provide a test certificate
addressing the “testing the effect of non-Siemens MR products on MR systems” as well as
“testing the effect of MR systems on non-Siemens MR products”. In all other cases, the
operator has to ensure that use of the non-Siemens MR product does not conflict with the
functions of the MR system and vice versa.
According to IEC 60601-2-33, the manufacturer of the MR system is obligated to provide a
data sheet covering technical information of the MR system to enable items to be assessed
for MR compatibility.
A display of the contours of equal field strength of the MR system begins on page 5 of this
manual.
Own liability and risk

Based on the information provided, the operator evaluates the non-Siemens MR product at
his own risk within the MR environment. Siemens shall not be held liable for any hazards
resulting from this evaluation.
MR compatibility test
Manufacturers of a non-Siemens MR product, who would like to obtain a test certificate
(“testing the effect of non-Siemens MR products on MR systems”) for their device from
Siemens, should get in touch with their Siemens sales engineer.
Parameters
All system-specific parameters are included in the “Technical Data” register of the System
Owner Manual.

3
MR compatibility protocols
According to IEC 60601-2-33, protocols need to be proposed for testing the functionality of
non-Siemens MR products. The protocols listed below are routinely used in the system.
! The tests cannot be used to evaluate the effects of the non-Siemens MR product on
the image quality of the MR system.
! None of the service sequences listed below can be used to confirm MR compatibility
or to define MR Conditional parameters of devices in the MR environment.
Program Card Description &

Service Sequence Parameters
Subdirectory Comments
Default/ se_multiecho Use default parameters or change Multiple RF pulses and
Default/ TR on the Routine parameter card gradient pulses.
ServiceSequences/ to minimum or according to SAR
Default limits to get max. RF power load.
On the Routine parameter card
change FoV and slice thickness to
minimum to get max. gradients.
rf_field Use default parameters or change Long (4 ms) powerful
TR on the Routine parameter card RF pulse.
to minimum or according to SAR
limits to get max. RF power load.
On the Routine parameter card
change FoV and slice thickness to
minimum to get max. gradients.
tuncal Use default parameters or change RF power only.
Flip angle on the Contrast param- Repetitive RF pulses.
eter card to maximum according
to SAR limits to get max. RF power The system-specific
load. frequency band is
measured in steps.
On the Resolution parameter card
change Phase resolution to maxi-
mum to increase scan time.
spike Use default parameters. Gradients only.
In case “gradient stimulation limit Repetitive multiple
exceeded” occurs change orienta- strong rapid gradient
tion to coronal or sagittal or run pulses.
sequence under Service_Patient.

4
Magnetic fringe field and control area

This table shows the effects of the magnetic fringe field on devices located in the vicinity
of the magnet and the safety distances required. Observe the minimum distances to be
maintained from the center of the x, y, and z axes of the magnet.
Note: 1 mT = 10 Gauss
Magnetic flux Minimum distances

Examples: Devices affected
density (x = y = radial, z = axial)
3 mT x = 1.84 m Small motors, watches, cameras, credit
z = 2.79 m cards, magnetic media
1 mT x = 2.20 m Oscilloscopes, computers, disk drives,
z = 3.46 m shielded color monitors
0.5 mT x = 2.50 m B/W monitors, magnetic media, cardiac
z = 4.00 m pacemakers, insulin pumps
0.2 mT x = 2.96 m Siemens CT systems
z = 4.88 m
0.1 mT x = 3.1 m Siemens linear accelerators
z = 5.5 m
0.05 mT x = 3.91 m X-ray I.I., gamma cameras, third party
z = 6.77 m linear accelerators

5
Spatial distributions
This section includes the following spatial distributions diagrams:
 Static magnetic field B0
 Spatial gradient of B0
 Product of the static magnetic field B0 and the spatial gradient of B0
Static magnetic field B0

The figures show lines of the same magnetic flux density in milliTesla.
The following graphics show the calculated magnetic field in air. Magnetic materials in the
vincinity of the magnet (i.e. iron beams or room shielding) may influence the form of the
stray field.
The plots represent three orthogonal planes through the isocenter to illustrate maximum
spatial extent of iso-magnetic contours.
Each plot contains the iso-magnetic contours with values of 0.5 mT, 1 mT, 3 mT, 5 mT,
10 mT, 20 mT, 40 mT, and 200 mT as well as a distance scale and a superimposed outline
of the MR system.
The 0.5 mT line marks the exclusion zone of the static magnetic field (pace maker limit).
Note: The magnetic field is rotationally symmetric about the z-axis and mirror symmetric
about the horizontal axis.
The multiple plots are shown to provide information about the accessible space in different
orientations.
This note also applies to the other magnetic field related plots.

6
View in the direction of the magnet axis
The graphic is referenced to plane z = 0.
1
Vertical (m)
−1
40 mT
20 mT
10 mT
5 mT
3 mT 1 mT
−2 0.5 mT
−3
−4
−5
−5 −4 −3 −2 −1 0 1 2 3 4 5
Horizontal (m)
Note: The 200 mT line is hidden behind the magnet cover.

7
Side view of the magnet
0.5
Vertical Axis (m)
mT
1m
1
3m
5m T
10 T
T
20 mT
40
20
T
T
m
m
0m
T
0
−1
−2
−3
−4
−5
−5 −4 −3 −2 −1 0 1 2 3 4 5
Z Axis (m)

8
Top view of the magnet
0.
5
1
Horizontal Axis (m)
m
m
T
T
20
1
3 T
5
10
m
m
40
20
m
T
T
m
0m
T
T
T
0
−1
−2
−3
−4
−5
−5 −4 −3 −2 −1 0 1 2 3 4 5
Z Axis (m)

9
The following graphs all represent one quarter of the magnet as indicated below.
The plot lines each run symmetric to the axis to the isocenter of the magnet. As a result,
the graphs can be unfolded.
Top view
Magnet
X Axis (m)
Z Axis (m)
Side view
Patient table
Y Axis (m)
Z Axis (m)
A small overview graphic is displayed on the following pages to indicate the area mapped
by the respective graph.

10
In the following we show a plot representing the 0.5 T, 1 T, and 1.5 T iso-magnetic con-
tours at positions accessible to and relevant for the MR worker as far as the static magnetic
field in the isocenter exceeds any of these values.
1.8
1.6
1.4
1.2
Vertical (m)
Side view
1
0.8
0.6
1.9 T
0.4
0.2 1.5 T
0.5 T
1T
0 Patient table
1.5 T
−0.2
0 0.2 0.4 0.6 0.8 1 1.2 1.4 1.6 1.8 2
Z Axis (m)
: At this location, the value of the magnetic field Bo is greatest.
! The iso-magnetic contour lines are accurate to a value better than 1%. There is very
little influence from the environment to the scanner. The graphic shows the cover in
nominal position. On a variety of scanners, the position can vary ±5 mm in the axial
direction. The maximum value therefore has a tolerance of ±10%, as small geometric
deviations can cause a significant change in the value.

11
1T
0.5 T
1.5 T
−0.2
1.5 T
−0.4 1.9 T
−0.6
−0.8
Horizontal (m)
−1
Top view
−1.2
−1.4
−1.6
−1.8
−2
0 0.2 0.4 0.6 0.8 1 1.2 1.4 1.6 1.8 2
Z Axis (m)
: At this location, the value of the magnetic field Bo is greatest.

12
Spatial gradient of the static magnetic field B0
The rise of the magnetic field as a function of the distance to the magnet is expressed by
the spatial gradient of B0. The following figures show lines with the same gradient in T/m.
The magnetic attraction force on a magnetically saturated ferromagnetic object is propor-
tional to this quantity.
Please note: Sometimes this quantity is expressed in G/cm (1 T/m = 100 G/cm).
1.8
1.6
1.4
1.2
Vertical (m)
Side view
1
0.8 0.
1T
/m
0.6
0.3
0.5
T/m
11 T/m
1T
T/m
/m
0.4 10 T/m
7 T/m
5 T/m
0.2
3 T/m
0.1 T/m
0.3 T/m
0.5 T/m
0
1 T/m
Patient table
3 T/m
−0.2
0 0.2 0.4 0.6 0.8 1 1.2 1.4 1.6 1.8 2
Z Axis (m)
: At this location, the force on a magnetically saturated ferromagnetic object is greatest.

13
0.1 T/m
0.3 T/m
0.5 T/m
1 T/m
1 T/m
0.5 T/m
0.3 T/m
0.1 T/m
3 T/m
−0.2
5 T/m
7 T/m
−0.4
11 T/m
−0.6
−0.8
Horizontal (m)
−1
Top view
−1.2
−1.4
−1.6
−1.8
−2
0 0.2 0.4 0.6 0.8 1 1.2 1.4 1.6 1.8 2
Z Axis (m)
: At this location, the force on a magnetically saturated ferromagnetic object is greatest.

14
Product of the static magnetic field B0 and the spatial gradient of B0
The magnetic attraction force on a diamagnetic/paramagnetic object or on a ferromag-
netic material below its magnetic saturation is proportional to this quantity.
1.8
1.6
1.4
1.2
Vertical (m)
Side view
1
0.8
0.
1T
0.3 T2 /m
0.6
2 /m
0.5 2 m
T/
1T
2 m
/
17 T2/m
0.4
10 T2/m
13 T2/m
5 T2/m
0.2
3 T2/m
0.1 T2/m
0.3 T/2m
0.5 T/m
1 T/2m
0 Patient table
3 T2/m
−0.2
0 0.2 0.4 0.6 0.8 1 1.2 1.4 1.6 1.8 2
Z Axis (m)
: At this location, the force on a diamagnetic/paramagnetic object or on a ferromagnetic

material below its magnetic saturation is greatest.

15
0.1 T2/m
0.3 T2/m
0.5 T2/m
1 T2/m
1 T2/m
0.5 T2/m
0.3 T2/m
0.1 T2/m
3 T2/m
−0.2 5 T2/m
10 T2/m
−0.4 13 T2/m
17 T2/m
−0.6
−0.8
Horizontal (m)
−1
Top view
−1.2
−1.4
−1.6
−1.8
−2
0 0.2 0.4 0.6 0.8 1 1.2 1.4 1.6 1.8 2
Z Axis (m)
: At this location, the force on a diamagnetic/paramagnetic object or on a ferromagnetic

material below its magnetic saturation is greatest.

16
Gradient stray field distribution relevant for assessing exposure to

MR workers
The diagrams show the magnetic stray field distribution of the gradient system along the
patient axis of the MAGNETOM Aera with the XQ or XJ gradient system respectively accord-
ing to the requirements of the IEC 60601-2-33 standard.
The magnetic fields generated by each of the three orthogonal gradient axis are calculated
on a coordinate grid on a virtual cylinder surface. The cylinder encompasses the patient
axis and starts in the magnet isocenter.
The grid is defined by:
 a point pattern on the surface of a virtual cylinder with a diameter of 70 cm (i.e. max.
bore liner);
 points on circles on the cylinder surface perpendicular to the cylinder axis with an
azimutal step width of 10 degrees (i.e. 36 points at the circumference) and an axial step
width of 4 cm.
The field values are calculated at max. currents that can be handled by the gradient ampli-
fiers. At each space point the field vectors generated by each gradient are calculated,
superimposed and then their magnitudes are derived. The max. magnitude field value that
can be found on each circle is selected and plotted along the z-axis.
By dividing the maximum field values by the shortest rise time, the dB/dt values can be
derived.
Shortest rise time Max dB/dt

XQ gradient 225 µs 70 mT/225 µs = 311 T/s
XJ gradient 264 µs 57 mT/264 µs = 216 T/s

17
|B| [T]
0.07
0.06
0.05
End of magnet
0.04
0.03
0.02
0.01
0.00
0.00 0.2 0.4 0.6 0.8 1.0 1.2 1.4 1.6 z [m]
Magnet isocenter
XQ gradient system
|B| [T]
0.06
0.05
0.04 End of magnet
0.03
0.02
0.01
0.00
0.00 0.2 0.4 0.6 0.8 1.0 1.2 1.4 1.6 z [m]
Magnet isocenter
XJ gradient system
The areas shaded in grey indicate the length of the magnet.

18
Spatial distribution of the gradient field at different positions

inside the gradient coil
The diagrams show the spatial distribution of the maximum magnitude values of the vec-
tor sum of the field components generated by each of the three gradient units simulta-
neously at positions on virtual cylinders coaxial with the patient axis with diameters of
0.2 m, 0.4 m, and 0.6 m.
The virtual cylinders have the same length as the gradient coil. In the cylinder axis direc-
tion the points have a separation of 0.02 m.
|B| [T]
0.04
End of gradient coil

0.03
0.02
0.60 m
0.40 m
0.01
0.20 m
0.00
0.0 0.5 1.0 1.5 2.0 z [m]
Magnet isocenter
XQ gradient system

19
|B| [T]
0.03
End of gradient coil
0.02
0.60 m
0.01 0.40 m
0.20 m
0.00
0.0 0.5 1.0 1.5 2.0 z [m]
Magnet isocenter
XJ gradient system
The areas shaded in grey indicate the length of the gradient coil.

20
RF power distribution relevant for assessing exposure to MR

workers
The diagram shows the RF power distribution along the patient axis of the MAGNETOM Aera
according to the requirements of the IEC 60601-2-33 standard.
1
End of magnet
0.1
relative B1(z)2/B1(0)2
0.01
0.001
0.0001
0.00001
0.000001
0.00 0.2 0.4 0.6 0.8 1.0 1.2 1.4 1.6 z [m]
Magnet isocenter
The RF field is calculated along the center line starting in the magnet isocenter. The area
shaded in grey indicates the length of the magnet.
The ratio B1(z)2/B1(0)2 provides a worst case estimation of the SAR contribution to a per-
son who is positioned at a distance z from the isocenter. The SAR contribution is relative to
the SAR that is applied to a person in the center of the patient bore.
For example a person standing in front of the system aperture absorbs a maximum of 0.2%
of the RF power which is applied to a patient scanned in the center of the bore.

21
Additional system characteristics
Magnet data
Operating field strength 1.5 Tesla
Magnet type Superconductor
Field stability over time <0.1 ppm/h
Weight (with cryogens) 3118 kg
Magnet length 137 cm
System length cover to cover 145 cm
Open Bore design1 70 cm
Refill interval (typical)2 Not applicable
Boil-off rate (typical)2 0.0 l/year
Max. helium capacity approx. 1280 liters
Minimum helium level 35%
Cryostat Stainless steel
1. incl. shim coils, gradient coil, RF body coil

2. For typical clinical use, depending on sequences and operating time with running helium compressor.
The system needs to be serviced at regular interval. Undisturbed magnet cooling for 24 hours and
7 days a week.

22
RF data
Peak power of transmitter amplifier 26.1 kW
Transmitter bandwidth 800 kHz
Receiver bandwidth 500 Hz–1 MHz (for each channel)
RF transmit coils
Body coil Max. applied RF field B1+ 27 µT
Max. specified B1+ rms 6.2 µT
Distance to isocenter, where RF transmit field is reduced by
3 dB 0.18 m
10 dB 0.38 m
TxRx CP Extremity Max. applied RF field B1+ 47 µT
Max. specified B1+ rms 17 µT
TxRx 15 Ch Knee Max. applied RF field B1+ 47 µT
TxRx Knee 15 Max. applied RF field B1+ 47 µT
TxRx CP Head Max. applied RF field B1+ 47 µT
Max. specified B1+ rms 12.5 µT

23
Tim table
Max. patient weight for vertical and horizontal table 250 kg (550 lbs)
movement
Max. scan range 140 cm; optional 205 cm1
Vertical table movement Range 52–102 cm2
+13 mm3
Speed 6 cm/s
Horizontal table move- Max. range 261 cm
ment
Max. speed 20 cm/s
Horizontal accuracy for ±0.5 mm
repositioning from one
direction
Continuous table movement during scan capable
1. With Tim Whole Body Suite option

2. Including Heightening Kit, if necessary
3. Depending on the floor conditions
Tim Dockable Table

movement
Max. scan range 140 cm; optional 205 cm1
+13 mm3
Speed 6 cm/s
Horizontal table move- Max. range 261 cm
ment
Max. speed 20 cm/s
direction


24
Patient comfort
Open bore design1 70 cm
In-bore lighting can be set at 6 different levels
In-bore ventilation can be set at 6 different levels
In-bore intercom including loudspeaker, microphone and earphones
Gradient data
XQ gradients
Performance for each axis
Max. amplitude 45 mT/m
Min. rise time 225 µs
Max. slew rate 200 T/m/s
Vector gradient performance (vector addition of all 3 gradient axes)
Max. eff. amplitude 78 mT/m
Max. eff. slew rate 346 T/m/s
Gradient duty cycle 100%
XJ gradients

MAGNETOM
MR
System Owner Manual
Guidance and manufacturer’s

declaration EMC
Aera
2
Data sheet
The following document applies to all products provided by the Magnetic Resonance (MR)
product group of Siemens Healthcare.
Deviations and additions to this document are provided in accompanying product-specific
documents. This information has to be followed respectively applied.
Medical electrical equipment needs special precautions regarding EMC and needs to be
installed and put into service according to the EMC information provided in the accompa-
nying documents.
Electromagnetic compatibility is the ability of an equipment or system to function satisfac-
torily in its electromagnetic environment without introducing intolerable electromagnetic
disturbance to anything in that environment.
Portable and mobile RF communications equipment can affect medical electrical equipment.
! Fixed equipment or system cabling, which can not be removed by the user, is not
listed. This cabling is part of the system and was regarded at all EMC-considerations.
Without this cabling there is no complete functionality of the system.
! The use of accessories, transducers and cables other than those specified, with the
exception of transducers and cables sold by the manufacturer of the equipment or
system as replacement parts for internal components, may result in increased emis-
sion or decreased immunity of the equipment or system.
RF shielding
! Failure to use MR system in the specified type of shield location could result in degra-
dation of the performance of this equipment, interference with other equipment or
interference with radio services.
! Recommended test methods for measurement of RF shielding effectiveness and
RF filter attenuation are given in the “Planing Guide System”.
! The use of RF emitting equipment, not released or certified by Siemens, inside the
shielded location of the MR system is not allowed, unless the equipment is switched
to an RF silent mode before entering the shielded location. In case of doubt please
check the operator manual or the guidelines of the respective 3rd party equipment.
Guidance and manufacturer’s declaration EMC

3
Electromagnetic emissions
The MR system is intended for use in the electromagnetic environment specified below. The
customer or the user of the MR system should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment — guidance

Radiated RF emissions Class A/Group 2 The MR system must emit electromagnetic energy
CISPR 11 in order to perform its intended function.
Nearby electronic equipment may be affected.
The MR system must be used only in a shielded
location (filters and cable feedthrough installed)
considering the following specifications:
7 T, including Multi-Nuclear Option:
 frequency range: 40–500 MHz
 minimum RF shielding effectiveness: >65 dB
 RF attenuation of the RF cabin itself (without any
feedthroughs or filters): >90 dB
1.5 T and 3 T, including Multi-Nuclear Option:

4
Emissions test Compliance Electromagnetic environment — guidance

Conducted RF emissions Class A/Group 2 The MR system must be used only in a shielded
CISPR 11 location (filters and cable feedthrough installed)
considering the following specifications:
7 T, including Multi-Nuclear Option:
1.5 T and 3 T, including Multi-Nuclear Option:
Verification of the shielding requirements is essen-
tial prior hand over of the system. The integrity of
the RF shielding is in the responsibility of the cus-
tomer.
The MR system, when installed in such a shielded
location, is suitable for use in all establishments
other than domestic and those directly connected
to the public low-voltage power supply network
that supplies buildings used for domestic purposes.
Harmonic emissions Not applicable
IEC 61000-3-2
Voltage fluctuations/ Not applicable
flicker emissions
IEC 61000-3-3
! It is essential that the actual shielding effectiveness and filter attenuation of the
shielded location be verified to assure that they meet the minimum specification.
! The emissions characteristics of this equipment make it suitable for use in industrial
areas and hospitals (CISPR 11 class A). If it is used in a residential environment (for
which CISPR 11 class B is normally required) this equipment might not offer adequate
protection to radio-frequency communication services. The user might need to take
mitigation measures, such as relocating or re-orienting the equipment.

5
In principle, MR systems may be used in combination with compatible equipment only.
The following definitions apply:
MR Safe An item that poses no known hazards in all MR environments.

MR Safe items include nonconducting, nonmagnetic items such
as a plastic petri dish. An item may be determined to be MR Safe
by providing a scientifically based rationale rather than test data.
MR Conditional An item that has been demonstrated to pose no known hazards
in a specified MR environment with specified conditions of use.
Field conditions that define the specified MR environment
include field strength, spatial gradient, dB/dt (time rate of
change of the magnetic field), RF fields, and SAR. Additional
conditions, including specific configurations of the item, may
be required.
MR Unsafe An item that is known to pose hazards in all MR environments.
MR Unsafe items include magnetic items such as a pair of ferro-
magnetic scissors.
! The MR system or equipment should not be used adjacent to other equipment, if adja-
cent or beside use is necessary, the equipment or system should be observed to verify
normal operation in the configuration in which it will be used.

6
Electromagnetic immunity
The MR system is intended for use in the electromagnetic environment specified below.
The customer or the user of the MR system should assure that it is used in such an environ-
ment. Normally, the MR system is used in a Professional Healthcare Environment.
Electromagnetic environ-
Immunity tests IEC 60601 test level Compliance level
ment — guidance
Electrostatic ±8 kV contact ±8 kV contact Floors should be wood, concrete
discharge (ESD) ±2/4/8/15 kV air ±2/4/8/15 kV air or ceramic tile. If floors are
IEC 61000-4-2 covered with synthetic material,
the relative humidity should be
at least 30%.
Electrical fast ±2 kV for power supply ±2 kV for power supply Mains power quality should be
transient/burst lines lines that of a typical commercial or
IEC 61000-4-4 ±1 kV for signal lines ±1 kV for signal lines hospital environment.
Surge ±0.5/1/2 kV line to ±0.5/1/2 kV line to Mains power quality should be
IEC 61000-4-5 ground ground that of a typical commercial or
±0.5/1 kV line to line ±0.5/1 kV line to line hospital environment.
Voltage dips, short <5% of a.c. mains Voltage interruptions; Mains power quality should be
interruptions and volt- voltage 0% UT; that of a typical commercial or
age variations on (>95% dip in a.c. 250/300 cycle hospital environment. If the
power supply input mains voltage) user of the equipment or sys-
lines IEC 61000-4-11 for 5 s tem requires continued opera-
tion during power mains
interruptions, it is recom-
mended that the equipment or
system be powered from an
uninterruptible power supply.
The MR system has a rated
input current of more than
16 A per phase.
Power frequency 30 A/m 30 A/m Power frequency magnetic
(50/60 Hz) magnetic fields should be at levels char-
field IEC 61000-4-8 acteristic of a typical location in
a typical commercial or hospital
environment.

7
IEC 60601 test Compliance

Immunity tests Electromagnetic environment — guidance
level level
Conducted RF inter- 0.15 MHz to 3 Vrms The MR system must be used only in a
ference 80 MHz: 3 Vrms shielded location (filters and cable
IEC 61000-4-6 feedthrough installed) considering the follow-
6 Vrms in ISM bands 6 Vrms
ing specifications.
between 0.15 MHz
and 80 MHz 7 T, including Multi-Nuclear Option:
Radiated RF inter- 80 MHz to 2.7 GHz: 3 V/m  frequency range: 40–500 MHz
ference 3 V/m  minimum RF shielding effectiveness: >65 dB
IEC 61000-4-3
 RF attenuation of the RF cabin itself (without
Proximity field 385 MHz: 27 V/m any feedthroughs or filters): >90 dB
from RF wireless 450 MHz: 28 V/m 1.5 T and 3 T, including Multi-Nuclear Option:
communications
equipment 710/745/780 MHz:  frequency range: 15–125 MHz
IEC 61000-4-3 9 V/m  minimum RF shielding effectiveness: >65 dB
810/870/930 MHz:  RF attenuation of the RF cabin itself (without
28 V/m any feedthroughs or filters): >90 dB
1720/1845/ Verification of the shielding requirements is
1970 MHz: 28 V/m essential prior hand over of the system. The
2450 MHz: 28 V/m integrity of the RF shielding is in the responsi-
bility of the customer.
5240/5500/
5785 MHz: 9 V/m Field strengths outside the shielded location
from fixed RF transmitters, as determined by
an electromagnetic site survey, should be less
than 3 V/m1.
Interference may occur in the vicinity of equip-
ment marked with the following symbol:
1. 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 mea-
sured field strength outside the shielded location in which the MR system is used exceeds 3 V/m, the MR system should be
observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as
relocating the MR system or using a shielded location with a higher RF shielding effectiveness and filter attenuation.
! These guidelines may not apply in all situations. Electromagnetic propagation is

affected by absorption and reflection from structures, objects and people.
! It is essential that the actual shielding effectiveness and filter attenuation of the
shielded location be verified to assure that they meet the minimum specification.

8
A MR system is classified as a large and permanently-installed equipment. Therefore, if
tested “in situ”, an exemption according to the following requirements of IEC 60601-1-2
has been used.
 36.202.3 b) 9.
 6.2.3.2i
 8.6
The equipment was not tested for radiated RF immunity over the entire frequency range
from 80 MHz to 6 GHz.
! MR system has been tested for radiated RF immunity only at selected frequencies, and
use nearby of emitters at other frequencies could result in improper operation

9
Recommended safety distances to RF communication equipments

The MR system is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the MR system can help prevent
electromagnetic interference by maintaining a minimum distance between portable and
mobile RF communications equipment (transmitters) and the MR system as recommended
below, according to the maximum output power of the communications equipment.
! Portable RF communications equipment (including peripherals such as antenna
cables and external antennas) should be used no closer than 30 cm (12 inches) to any
part of the equipment or system, including cables specified by the manufacturer.
Otherwise, degradation of the performance of this equipment could result.
The MR system was tested according to the table below (IEC 60601-1-2:2014, table 9):
Test Immunity
Maximum
frequency Band (MHz) Service Modulation Distance (m) test level
power (W)
(MHz) (V/m)
385 380–390 TETRA 400 Pulse modulation 1.8 0.3 27
18 Hz
450 430–470 GMRS 460; FM 2 0.3 28
FRS 460 ±5 kHz deviation
1 kHz sine
710 704–787 LTE Band 13, Pulse modulation 0.2 0.3 9
17 217 Hz
745
780
810 800–960 GSM 800/900; Pulse modulation 2 0.3 28
TETRA 800; 18 Hz
870
iDEN 820;
930 CDMA 850;
LTE Band 5
1720 1700–1990 GSM 1800; Pulse modulation 2 0.3 28
CDMA 1900; 217 Hz
1845
GSM 1900;
1970 DECT;
LTE Band 1, 3,
4, 25;
UMTS

10
Test Immunity
Maximum
frequency Band (MHz) Service Modulation Distance (m) test level
power (W)
(MHz) (V/m)
2450 2400–2570 Bluetooth; Pulse modulation 2 0.3 28
WLAN 217 Hz
802.11 b/g/n;
RFID 2450;
LTE Band 7
5240 5100–5800 WLAN 802.11 Pulse modulation 0.2 0.3 9
a/n 217 Hz
5500
5785
! The MR system may be interfered with by other equipment, even if that other equip-
ment complies with CISPR emission requirements.

11
Basic safety and essential performance

As a result of the risk management process for the MR systems (according to IEC 60601-1:
2005 + CORR. 1 (2006) + CORR. 2 (2007) + AM 1 (2012) or IEC 60601-1: 2012), no essen-
tial performance was identified.
MR systems provide basic safety and essential performance in the electromagnetic
environments of the intended use throughout their expected service life. Please refer to
the “Maintenance Plan” for all necessary instructions to maintain basic safety and essential
performance with regard to electromagnetic disturbances for the expected service life.
MR systems apply RF energy for diagnosis. As such, MR systems may interfere with other
equipment located nearby.
MR systems receive RF signals for the purpose of their operation. Thus, MR systems may be
interfered by other equipment, even if that other equipment complies with CISPR emission
requirements.
! Please note, RF surgical equipment is not compatible with MR systems.
Frequency bands for operation of MR systems are as follows.
63.6 MHz 1.5 T

123.2 MHz 3T
15 MHz–125 MHz 3 T (Multi-Nuclear Option)
296.18 MHz 7T
The MR system applies IQ-modulated (without encoding any data) repeated RF pulses. This
results in a total bandwidth of the modulated signal of less than ±500 kHz around applied
carrier (<125 MHz).

12

MAGNETOM
MR
System Owner Manual
Technical data
Aera
2
General remark
The following pages describe common information and information specific for the system
configuration with XJ gradients. Please find specific information for MAGNETOM Aera sys-
tems with XQ gradients beginning on page 31.
Magnet system
 Short-bore, patient-friendly design, high homogeneity
 Easy siting due to AS (Active Shielding) and E.I.S. (External Interference Shielding)
magnet technology
 Operating mode: Standard operating mode according to IEC 60601-2-33.
Magnet parameters
Operating field strength 1.5 Tesla
Magnet type Superconductor
Field stability over time <0.1 ppm/h
Weight (with cryogens) 3118 kg
Magnet length 137 cm
System length cover to cover 145 cm
Open Bore design1 70 cm
Type of installation Fixed
Decay characteristics from full field to approx. 20 seconds
20 mT
Technical data
3
Homogeneity (based on highly accurate 24 plane plot)

Guaranteed Typical
10 cm DSV 0.02 ppm 0.01 ppm
20 cm DSV 0.075 ppm 0.06 ppm
50×50×45 cm3 DEV 4.0 ppm 3.1 ppm
In compliance with the German “Qualifikationsvereinbarung”.

Standard deviation Vrms (Volume root-mean square) measured with highly accurate 24 plane plot method
(20 points per plane).
Standard active shim with 3 linear channels.
DSV = Diameter spherical volume (x, y and z direction).
DEV = Diameter elliptical volume.
Shimming
Both: passive and active shimming. Passive shimming during installation.
Standard active shim with 3 linear channels (1st order). Additional 5 non linear chan-
nels (2nd order) as option (XQ gradients).
3D Shim Patient-specific automated shim
Time to shim = approx. 20 s
Technical data
4
Shielding
Active Shielding (AS) 5th generation active shielding (AS) tech-
nology with counter coils
Fringe field (axial×radial) 0.5 mT1 4.0 m×2.5 m
0.1 mT 5.5 m×3.1 m
External Interference Shield (E.I.S.) Patented shielding system integrated into
the magnet
Continuous compensation and automatic
suppression of external magnetic field
interferences during measurement (caused
by moving ferromagnetic objects or nearby
power lines)
1. pacemaker safety limit
Magnet cooling system

Refill interval (typical)1 Not applicable
Boil-off rate (typical)1 0.0 l/year
Max. helium capacity approx. 1280 liters
Minimum helium level 35%
Cryostat Stainless steel
1. For typical clinical use, depending on sequences and operating time with running helium compressor.
The system needs to be serviced at regular interval. Undisturbed magnet cooling for 24 hours and
7 days a week.
Technical data
5
Static magnetic field

Maximum static magnetic field 1.9 T
Maximum spatial gradient of static mag- 11 T/m
netic field
Maximum product of the static mag- 17 T2/m
netic field and spatial gradient of static
magnetic field
Technical data
6
Patient handling
The patient table is available in two different configurations:
Tim table
movement
Max. scan range 140 cm
optional 205 cm1
+13 mm3
Speed 6 cm/s
Horizontal table movement Max. range 261 cm
Max. speed 20 cm/s
direction

Technical data
7
Tim Dockable Table

movement
Max. scan range 140 cm
optional 205 cm1
+13 mm3
Speed 6 cm/s
Horizontal table movement Max. range 261 cm
Max. speed 20 cm/s
direction

Technical data
8
Hearing protection data

The A-evaluated, effective sound pressure level was measured according to NEMA
MS 4-2006 (National Electrical Manufacturers Association) using the maximum gradient
acoustic noise (MGAN) method.
Patient noise
Patients require hearing protection with an SNR1 = 18 dB or more
1. SNR = Single Number Rating
Noise for personnel in the examination room

Noise measured 83.1 dB(A)
Hearing protection SNR = 1 dB or more
Technical data
9
Gradient system
General features
Actively shielded (AS) whole-body gradient coil system
Extremely low eddy currents
Water-cooled coil and amplifier for maximum performance
All axes force compensated
Gradient amplifier
 Water-cooled, highly compact, modular design
 Ultra-fast solid-state technology with very low switching losses
Max. output voltage1 2000 V
Max. output current1 625 A
1. Values for each of the 3 gradient axes
Performance
Technical data
10
DirectRF™ technology
Direct transmit technology

Frequency stability ±2×10–10
(5 min)
Frequency control 32 bits (0.015 Hz)
Phase control 16 bits (0.006 degrees)
Body coil Integrated whole body no tune transmit/receive coil with
16 rungs
Optimized RF efficiency and signal-to-noise ratio (SNR)
Transmitter path Feedback loop for excellent RF stabilization
Transmit amplitude 16 bit control 25 ns resolu-
tion
Gain stability (after first <0.05 dB (1 s)
minute) <0.2 dB (5 min)
Transmitter amplifier Extremely compact, water-cooled solid state amplifier,
integrated at the magnet as part of DirectRF™ technology
Transmit amplifier band- 800 kHz
width
Peak power 26.1 kW
Technical data
11
RF receiver technology
Maximum number of channels1 204
Number of independent receiver 24, 48, 642
channels that can be used simulta-
neously in one single scan in one FOV,
each generating an independent partial
image
Quadrature demodulation and filtering Digital
Receiver bandwidth 500 Hz–1 MHz (for each channel)
Receiver signal resolution 32 bit
ADC sampling rate 80 MHz
Preamplifier noise figure <0.5 dB
Dynamic range at coil connector 164 dB instantaneous at receiver
(referred to 1 Hz resolution bandwidth) 169 dB with automatic gain control at local
coil connector
1. Channels (coil elements) that can be connected simultaneously

2. Optional
Technical data
12
RF coils
Intended use
Coil name Coil type Coil design Resonant
Applications
nuclei
Body 18 Receive 18 Channel 1H  Examinations of the upper body and the
phased array abdomen
 Examinations of the pelvis
Head/Neck 20 Receive 20 Channel 1H  Examinations of the head and the neck
phased array (e.g. nape of the neck and vessels of the
neck)
 Combined measurements with other
coils
Spine 32 Receive 32 Channel 1
H  Examinations of the spine
phased array  Combined measurements with other
coils
Flex Large 4 Receive 4 Channel 1
H  Imaging of large regions such as medium
phased array to large shoulder, hip, and knee
Flex Small 4 Receive 4 Channel 1
H  Imaging of small regions such as small to
phased array medium shoulder, wrist, elbow, and
ankle
Peripheral Angio 36 Receive 36 Channel 1H  Vascular examinations of the lower
phased array extremities
Technical data
13
Intended use
Applications
nuclei
Loop 11 Receive Linear 1H  Examinations of the skin, for example,
melanoma, birth marks, and other skin
anomalies
 Examinations of fingers, wrist bones, or
toes
Loop 7 Receive Linear 1
H  Examinations of the skin, for example,
anomalies
toes
Loop 4 Receive Linear 1H  Examinations of the skin, for example,
anomalies
toes
Hand/Wrist 16 Receive 16 Channel 1H  Examinations of wrists, hands, and
phased array fingers
Foot/Ankle 16 Receive 16 Channel 1H  Examinations of feet and ankles
phased array
Shoulder Large 16 Receive 16 Channel 1H  Examinations of the shoulder
phased array
Shoulder Small 16 Receive 16 Channel 1H  Examinations of the shoulder
phased array
Technical data
14
Intended use
Applications
nuclei
TxRx CP Extremity Transmit/ Quadrature 1H  Examinations of the left or right knee
Receive birdcage
TxRx 15 Ch Knee Transmit/ Transmit: 1H  Examinations of the left or right knee
Receive quadrature
birdcage
Receive:
15 Channel
phased array
TxRx Knee 15 Transmit/ Transmit: 1H  Examinations of the left or right knee
Receive quadrature
birdcage
Receive:
15 Channel
phased array
TxRx Knee 15 Flare Transmit/ Transmit: 1H  Examinations of the left or right knee
Receive quadrature
birdcage
Receive:
15 Channel
phased array
4 Ch BI Breast Receive 4 Channel 1H  Biopsy examinations
phased array  High-resolution breast imaging
16 Ch AI Breast Receive 16 Channel 1
H  Biopsy examinations
phased array  High-resolution breast imaging
Breast 18 Receive 18 Channel 1
H  Examinations of female patients
phased array  Simultaneousl display of both sides of the
breast for comparative evaluations
Technical data
15
Intended use
Applications
nuclei
2-/4-/8-Channel Receive Optional 2, 4, 1H  Biopsy examinations
Sentinelle Breast or 8 Channel  Conventional breast imaging
Coil phased array
2-/10-/16-Channel Receive Optional 2, 1H  Biopsy examinations
Sentinelle Breast 10, or 16  Conventional breast imaging
Coil Channel
phased array
Body 6 Receive 6 Channel 1H  Examinations of the upper body and the
phased array abdomen
Body 6 Long Receive 6 Channel 1H  Body 6 with extended coil cable
phased array  Examinations of the upper body and the
abdomen
Body 18 Long Receive 18 Channel 1H  Body 18 with extended coil cable
phased array  Examinations of the upper body and the
abdomen
Body 301 Receive 30 Channel 1H  Examinations of the upper body,
phased array abdomen, and liver
 Examinations of the heart
Body 602 Receive 60 Channel 1H  Examinations of the upper body,
phased array abdomen, and liver
 Examinations of the heart
Technical data
16
Intended use
Applications
nuclei
Head/Neck 163 Receive 16 Channel 1H  Examinations of the head and the neck
phased array (e.g. nape of the neck and vessels of the
neck)
 Combined measurements with other
coils
Spine 243 Receive 24 Channel 1
H  Examinations of the spine
phased array  Combined measurements with other
coils
Endorectal Receive Linear 1
H  Examinations of the prostate, colon, and
Cervix Uteri
Prostate 2 Receive 2 Channel 1
H  Examinations of the prostate, colon, and
phased array the surrounding tissue in the pelvis
TxRx CP Head Transmit/ Quadrature 1
H  Vascular examinations in the head
Receive birdcage
Special Purpose 4 Receive 4 Channel 1
H  Examinations of small body regions near
phased array the skin surface
Pediatric 16 Receive 16 Channel 1
H  Imaging of the head and neck of
phased array neonates and infants4
1. Not available for MAGNETOM Aera with 24-channel configuration

2. Only available for MAGNETOM Aera with 64-channel configuration
3. Only available for MAGNETOM Aera with 24-channel configuration
4. MR scanning has not been established as safe for imaging fetuses and infants under two years of age. The responsible phy-
sician must evaluate the benefit of the MRI examination in comparison to other imaging procedures.
Technical data
17
Sequences
Basic set of sequences provided on the scanner.
Spin echo family of sequences

 SE (Spin Echo): single and multi echo
 TSE (Turbo Spin Echo)
 HASTE (Half-Fourier Acquisition with Single Shot Turbo Spin Echo)
 SPACE (Sampling Perfection with Application-optimized Contrast using different flip
angle Evolutions): for fast 3D spin echo imaging
Gradient echo family of sequences

 FLASH (Fast Low Angle SHot): spoiled GRE (gradient echo)
 VIBE (Volume Interpolated Breathhold Examination): for fast 3D gradient echo imaging
 MEDIC (Multi Echo Data Image Combination)
 DESS (Dual Echo Steady State)
 TurboFLASH
 FISP (Fast Imaging with Steady State Precession)
 EPI (Echo Planar Imaging): with signal type SE or FID (Free Induction Decay)
 ToF (Time-of-Flight) Angiography
 PC (Phase Contrast) Angiography
 CV/BEAT: comprehensive sequence for cardiac imaging
Technical data
18
Computer system
syngo Acquisition Workplace

Host computer Processor Intel Xeon  E5-1620
Quad-Core
Clock rate 3.6 GHz
Main memory (RAM) 32 GB
1st hard disk (system SW) 300 GB SAS
2nd hard disk (data base) 300 GB SAS
3rd hard disk (images) 300 GB SAS
CD-R writer Approx. 4000 images 2562;
DICOM Standard, ISO 9660
DVD-R writer Approx. 25000 images 2562;
DICOM Standard, ISO 9660
Media drives CD/DVD drive
Color LCD monitor1 Screen size (diagonal) 19”
Horizontal frequency 30–100 kHz
Vertical frequency 50–75 Hz
Screen matrix 1280×1024 pixels
Measurement and Processor Intel  E3-1225 Quad-Core,
reconstruction system or better
(system configuration
Clock rate 3.2 GHz, or comparable
with 24 receiver chan-
nels) Main memory (RAM) 32 GB
Hard disk for raw data 300 GB
Hard disk for system software 100 GB
Parallel Scan and Recon Simultaneous scan and recon-
struction of up to 12 data sets
Reconstruction speed 12987 recons per second
(2562 FFT, full FoV)
57971 recons per second
(2562 FFT, 25% recFoV)
1. A standard monitor without calibration is not suitable for diagnostic purposes. Please consider the ini-
tial acceptance testing for image display devices and the follow-up service for constancy testing on a
regular base, as offered by Siemens service.
Technical data
19

Measurement and Processor Intel  E5-2620 2×6-Core,
(system configuration
Clock rate 2×2.0 GHz, or comparable
with 48 receiver chan-
nels) Main memory (RAM) 48 GB
(2562 FFT, 25% recFoV)

Measurement and Processor Intel Xeon E5-2658 2×8-Core,
(optional system con-
Clock rate 2×2.1 GHz
figuration with
64 receiver channels) Main memory (RAM) 64 GB
(2562 FFT, 25% recFoV),
or higher
GPGPU 1×Tesla K10
Technical data
20
syngo MR Workplace (optional)

Color LCD monitor and host computer as for syngo Acquisition Workplace
Euro Connector (System IEC 320)

Load rating 100–240 Vac
50–60 Hz
max. 10 A
Network/data coupling
The MR system provides the level of safety according IEC 60950-1 outside patient environ-
ment. All equipment connected to the system’s network/data couplings must also provide
minimum level of safety according IEC 60950-1.
Technical data
21
syngo MR image viewing and filming

Image display
 Various display layouts selectable
 Up to 3 patients can be simultaneously active in the viewer
 Image annotation and labeling
 Non-interpolated display
 Fast paging through up to 500 images with 15 images/s for full screen display
Windowing
 Freely selectable window width and center
 Windowing on succeeding images
 Auto-windowing for optimized contrast
 Saves and sends window values
Interactive movie/Automatic Movie for cine display

Paging by dragging the mouse or Automatic Movie mode by clicking the icon
Evaluation
Parallel evaluation of up to 40 regions of interest
 Circle
 Rectangle
 Freehand ROI
 Pixel lens with position marker
 Statistical evaluation
 Area
 Standard deviation
 Mean value
 Min/max values
 Image scrolling
 Magnification
 Distance
 Angle
Technical data
22
2D Post-processing
Image manipulations
 Reversal of gray-scale values
 Image rotation by 90° or by user-defined angle
 Flip horizontally/vertically
 Image zoom and pan
 Shutter
 Annotation
Position display
Displays measured slice positions on localizer image and selected series
Mean Curve
Time-intensity analysis
 Creates and edits DICOM structured reports
Filming
 Connection via DICOM Basic Print
 Interactive filming
 Filming parallel to other activities
 Independent scanning and documentation – no wait time due to camera delays
 Freely selectable positioning of images onto virtual film sheet
 Selectable various film layouts
 Mother-in-Child display
 Windowing, image zoom and pan on film sheet
 Configurable image text
 Simultaneous handling of multiple film jobs
 Up to 100 virtual film sheets
Technical data
23
Argus Viewer
Viewing software for cardiac MR studies and large data sets
 Efficient cine review of cardiac and other dynamic data sets
 Multiple sorting options
 Single movie as well as 2, 4, or 8 simultaneous slices together in movie mode
 Rapid avi creation of 1 to 8 slices simultaneously
 Creates and edits DICOM structured reports
Dynamic Analysis
Arithmetic operations on images and series
 Addition, subtraction, multiplication, division of single images and whole series
 Arithmetic mean and standard deviation across a range of selected images
 Calculation of T1 and T2, and logarithmic images
 Differentiation/integration of selected images
 Calculation of a mean slope image from a range of selected images
 Calculation of z-score (t-test) images for evaluation of BOLD imaging data (Blood
Oxygenation Level Dependent)
 Time-to-peak evaluation (TTP)
 ADC maps
Several evaluation functions may be started consecutively in the background
Printing on paper
Interface and software for printing images on paper (laser printer not included)
 Grey levels and color printing supported
 Data format Postscript Level 2
Technical data
24
3D Post-processing
MPR – Multi-Planar Reconstruction
Real-time multi-planar reformatting of secondary views
 Viewing perspectives: sagittal; coronal; axial; oblique; double oblique; curved (freehand)
 Reconstruction along polygon and/or curved (freehand) cut lines
 Reconstruction based on reconstructed planes possible
 Reconstruction of user-defined ranges of parallel, radial or freehand cuts
 Selectable slice thickness and slice increment of reconstructed images
 Storing of post-processing protocols
 Annotations and 2D evaluations such as distance and ROI
MIP – Maximum Intensity Projection

3D reconstructions of vessels from a 3D data set, or a 2D sequential slice data set (acquired
with dedicated MR Angiography sequences)
 Volume of Interest (VoI) defined to increase reconstruction speed and to improve image
quality
 Freehand MIP
 Arbitrary views along any direction can be defined interactively with mouse-driven virtual
trackball
 Multiple view angles around any orthogonal axis
 Projections displayed as single images, as interactive movie or by fast paging
 MIP thin/MIP thick
MinIP – Minimum Intensity Projection

Similar to MIP but reconstructs the minimum intensity (e.g. for Dark Blood techniques)
SSD – Shaded Surface Display

Three-dimensional display of surfaces, such as vessels
 Selectable variable threshold values
 Multiple view angles around any orthogonal axis
 Rectangular and irregular Volumes of Interest (VoI) can be defined to improve image
quality
Technical data
25
Ambient conditions
Control room
Temperature 15–30 °C (59–86 °F)
Relative air humidity 40 to 60%
Absolute air humidity <11.0 g/kg
Air pressure 1060–700 hPa1
Electronics room
Examination room
1. 700 hPa is equivalent to a height of about 3000 m above sea level
Technical data
26
Specific absorption rates

The specific absorption rate for the RF power and the rate of change of the gradient fields
are checked according to the requirements of norm IEC 60601-2-33.
For details about the operating modes, see: Operator Manual MR System.
Cooling system
Two different customer specific cooling alternatives (Separator or Eco Chiller) are avail-
able.
Separator option (for connec- Water consumption 70 l/min1

tion to available cooling sys-
Heat dissipation to water 45 kW
tem)
Eco Chiller option with auto- GREEN Cooling Package2:
matic adaptation to the  Reduces energy consumption by up to 50%
required cooling demands (e.g.
different night/day mode) to  Automatic start if the surrounding temperature is
decrease energy cost 18 °C (64 °F) or less
 If the temperature is less than –3 °C (27 °F) the
chiller is switched off3
1. Water temperature: 12 °C (54 °F)

2. Free Cooling Unit, optional
3. In case of clinical routine measurement conditions
Technical data
27
Line power supply
Values Tolerance
Voltage 380 V, 400 V, 420 V, 440 V, ±10%
460 V, 480 V
Frequency 50/60 Hz ±1 Hz
Connection value 63 kVA for 480 V/400 V,
62 kVA for 380 V
For all products, line power has to be supplied via an on-site system contact or via another
multipole shut-down mechanism. Room installation has to be in compliance with
VDE 0100-7101.
1. In all countries, compliance with local and national legal regulations is required.
However, we strongly recommend compliance with the regulations described herein – to the extent permit-
ted by relevant local and national laws – in order to ensure the safety of operating personnel, patients, and
third parties.
Power rating plate
380/400/420/440/460/480 V ~
3PHASE 50/60 Hz
SHORT – TIME kVA: 75
LONG – TIME kVA: 20
Technical data
28
Power consumption
Off1 6.1 kW
System ready to measure1 8.7 kW
Scan1 18.9 kW
Remarks:
 All values are typical values, applicable for 400 V/50 Hz.
 Consumption for optional separator pump not included.
1. The power consumption described herein is based on results that were achieved in a setting according
to the COCIR methodology MRI - Measurement of the energy consumption (http://www.cocir.org/site/
index.php?id=46). Since many variables impact power consumption (e.g. sequences used for scan-
ning and sequence parameters, scan time), there can be no guarantee that each customer will achieve
the same values.
Technical data
29
General classifications
Protection class I
Components used
 Patient table Type B applied part
 Local coils Type B or BF applied part
 Body coil Type B applied part
 ECG/Pulse module Type BF applied part
IP protection class according to IP X0
IEC 60529
Explosion protection The MR system is not intended for opera-
tion in areas prone to explosion (e.g.,
highly flammable mixtures of anaesthesia
gases with air or oxygen or nitrous oxide)
Operating mode Continuous operation with short-term load
Disinfection receptors/system compo- Disinfectants without alcohol, ether
nents
Degree of safety in the presence of a No AP or APG category equipment
flammable anesthetics mixture with air
or with oxygen or with nitrous oxide
Mains operated equipment with addi- None
tional power sources
Technical data
30
Dimensions
Heat
Width Depth Height Weight dissipa-
Component
[cm] [cm] [cm] [kg] tion
[kW]
Examination Room
Magnet 1.5 Tesla AS 205 137 215 3118
(incl. Helium)
Magnet in operation, 231 405 219 4798
incl. gradient coil, 4331
body coil, Tim table,
and covers
Tim table 76 249 52–1022
+13 mm3
Required min. room 2404
height clearance
Min. transport dimen- 231 155 214
sions
Control Room
syngo Acquisition 120 80 117
Workplace (72+45)
(table+monitor)
Host computer 22 46 47
syngo MR Workplace 120 80 117
(optional) (72+45)
(table+monitor)
Equipment Room
Electronics cabinet, 160 65 1985 1500 56
incl. system control,
RF system, gradient
power system, image
processor
Cooling system 65 65 189 500

4. Finished floor to finished ceiling
5. Without attachments
6. Only ventilation might be required
Technical data
31
MAGNETOM Aera XQ gradients

Magnet system
Homogeneity (based on highly accurate 24 plane plot)

Guaranteed Typical
10 cm DSV 0.01 ppm 0.003 ppm
50×50×45 cm3 DEV 4.0 ppm 3.0 ppm
In compliance with the German “Qualifikationsvereinbarung”.

Standard deviation Vrms (Volume root-mean square) measured with highly accurate 24 plane plot method
(20 points per plane).
Active shim with 3 linear and 5 non-linear channels (2nd order).
DSV = Diameter spherical volume (x, y and z direction).
DEV = Diameter elliptical volume.
Shimming
Both: passive and active shimming. Passive shimming during installation.
Standard active shim with 3 linear channels (1st order). Additional 5 non linear chan-
nels (2nd order).
3D Shim Patient-specific automated shim
Time to shim = approx. 20 s
Technical data
32
Hearing protection data
The A-evaluated, effective sound pressure level was measured according to NEMA
MS 4-2006 (National Electrical Manufacturers Association) using the maximum gradient
acoustic noise (MGAN) method.
Patient noise
Patients require hearing protection with an SNR1 = 22 dB or more
1. SNR = Single Number Rating
Noise for personnel in the examination room

Noise measured 86.1 dB(A)
Hearing protection SNR = 4 dB or more
Gradient system
Gradient amplifier
 Water-cooled, highly compact, modular design
 Ultra-fast solid-state technology with very low switching losses
Max. output voltage1 2250 V
Max. output current1 900 A
1. Values for each of the 3 gradient axes
Performance
Technical data
33
Cooling system
Two different customer specific cooling alternatives (Separator or Eco Chiller) are avail-
able.
Separator option (for connec- Water consumption 90 l/min1

tion to available cooling sys-
Heat dissipation to water 60 kW
tem)
Eco Chiller option with auto- GREEN Cooling Package2:
matic adaptation to the  Reduces energy consumption by up to 50%
required cooling demands (e.g.
different night/day mode) to  Automatic start if the surrounding temperature is
decrease energy cost 18 °C (64 °F) or less
 If the temperature is less than –10 °C (14 °F) the
chiller is switched off3
1. Water temperature: 12 °C (54 °F)

2. Free Cooling Unit, optional
3. In case of clinical routine measurement conditions
Line power supply
Values Tolerance
Voltage 380 V, 400 V, 420 V, 440 V, ±10%
460 V, 480 V
Frequency 50/60 Hz ±1 Hz
Connection value 88 kVA for 480 V/400 V,
90 kVA for 380 V
For all products, line power has to be supplied via an on-site system contact or via another
multipole shut-down mechanism. Room installation has to be in compliance with
VDE 0100-7101.
1. In all countries compliance with local and national legal regulations is required.
However, we strongly recommend compliance with the regulations described herein – to the extent permit-
ted by relevant local and national laws – in order to ensure the safety of operating personnel, patients, and
third parties.
Technical data
34
Power rating plate
380/400/420/440/460/480 V ~
3PHASE 50/60 Hz
SHORT – TIME kVA: 102
LONG – TIME kVA: 20
Power consumption
Off1 6.1 kW
System ready to measure1 9.3 kW
Scan1 22.5 kW
Remarks:
 All values are typical values, applicable for 400 V/50 Hz.
 Consumption for optional separator pump not included.
1. The power consumption described herein is based on results that were achieved in a setting according
to the COCIR methodology MRI - Measurement of the energy consumption (http://www.cocir.org/site/
index.php?id=46). Since many variables impact power consumption (e.g. sequences used for scan-
ning and sequence parameters, scan time), there can be no guarantee that each customer will achieve
the same values.
Technical data
MAGNETOM
MR
System Owner Manual
Location of labels
Aera
Avantofit
Prisma/Prismafit
Skyra/Skyrafit
2
At the electronics cabinet

Name plate label
MAGNETOM XXXX
(01) 00000123456789 GTIN
(240) 01234567 MODEL
(422) 012 ORIGIN DE
(21) 01234 SERIAL 2016 0123
SYSTEM IVK
Siemens Healthcare GmbH, Henkestr. 127
91052 Erlangen, Germany
Made in Germany
Labels according to EN 50419:2006
Within the EU, products identified with this symbol are subject to guidelines 2002/96/EC
for old electrical or electronics system and 2012/19/EU respectively. Please contact
Siemens Service in case of questions about returning and disposing the MR system and/or
its components and accessories.
Approval identification for Canada/USA

CSA = Canadian Standards Association
Revision label
Location of labels
3
On the magnet cover

Name plate label
MAGNETOM XXXX
(01) 00000123456789 GTIN
(240) 01234567 MODEL
(422) 012 ORIGIN DE
(21) 01234 SERIAL 2016 0123
SYSTEM IVK
Siemens Healthcare GmbH, Henkestr. 127
91052 Erlangen, Germany
Made in Germany
Approval identification for Canada/USA

CSA = Canadian Standards Association
Location of labels
4
At the magnet bore (front)

Risk of injury
Observe operator manual
Location of labels
5
For laser light localizer

Safety certificate label (International)
Safety certificate label (U.S.A. only)

Complies with 21 CFR 1040.10 and 1040.11
except for deviations pursuant to Laser
Notice No. 50, dated June 24, 2007
Manufactured: MAY 2015
Henkestr. 127, 91052 Erlangen
Germany
Location of labels
6
Location of labels
The Maintenance Plan has been removed
and is only available in the printed version
of the System Owner Manual.
MAGNETOM
MR
System Owner Manual
Disposal
Aera
Avantofit
Prisma/Prismafit
Skyra/Skyrafit
2
Equipment disposal
On disposing of the system or parts thereof, currently valid environmental legislation must
be observed.
Examples of environmentally relevant components are:
 Accumulators and batteries
 Transformers
 Capacitors
 Monitor picture tubes
 Phantoms
For details contact your local customer service representative or your Siemens regional
office.
NOTICE: System components hazardous to persons or the environment must be dis-
posed of with care and in compliance with legally binding ordinances.
Disposal
MAGNETOM
MR
System Owner Manual
Manufacturer Disclosure Statement

for Medical Device Security – MDS2
Aera
Avantofit
Prisma/Prismafit
Skyra/Skyrafit
Manufacturer Disclosure Statement for Medical Device Security – MDS2
HN 1-2013
Manufacturer Disclosure Statement for Medical Device Security – MDS2

DEVICE DESCRIPTION
Device Category Manufacturer Document ID Document Release Date
MRI see last page n.a. n.a.
Device Model Software Revision Software Release Date
MAGNETOM Systems syngo MR E11 n.a.
Manufacturer or Company Name Manufacturer Contact Information

Representative Siemens Healthcare GmbH http://www.healthcare.siemens.com/magnetic-resonance-
Contact Representative Name/Position imaging
Information .
Intended use of device in network-connected environment:
The MRI Scanner is used to create diagnostic images which can be sent via the local network to DICOM nodes.
Note: External network connection (e.g. hospital network) is not mandatory to operate MAGNETOM systems.
Purpose of integrating the Device into an IT-Network (see Annex Z for details):
DICOM communication node for image transfer; SRS - Siemens Remote Service support
MANAGEMENT OF PRIVATE DATA
Yes, No,
Note #
Refer to Section 2.3.2 of HIMSS/NEMA HN 1-2013 standard for the proper interpretation of information requested
N/A, or
in this form.
See Note
A Can this device display, transmit, or maintain private data (including electronic Protected Health
Information [ePHI])? ........................................................................................................................................ Yes
B Types of private data elements that can be maintained by the device:
B.1 Demographic (e.g., name, address, location, unique identification number)? ........................................... Yes
B.2 Medical record (e.g., medical record #, account #, test or treatment date, device identification number)? Yes
B.3 Diagnostic/therapeutic (e.g., photo/radiograph, test results, or physiologic data with identifying
characteristics)? ........................................................................................................................................ Yes
B.4 Open, unstructured text entered by device user/operator? .................................................................... Yes
B.5 Biometric data? ....................................................................................................................................... No 1
B.6 Personal financial information? ................................................................................................................. No
C Maintaining private data - Can the device:
C.1 Maintain private data temporarily in volatile memory (i.e., until cleared by power-off or reset)? ............. Yes
C.2 Store private data persistently on local media? ....................................................................................... Yes
C.3 Import/export private data with other systems?........................................................................................ Yes
C.4 Maintain private data during power service interruptions? ...................................................................... Yes
D Mechanisms used for the transmitting, importing/exporting of private data – Can the device:
D.1 Display private data (e.g., video display, etc.)? ....................................................................................... Yes
D.2 Generate hardcopy reports or images containing private data? ............................................................... Yes 2
D.3 Retrieve private data from or record private data to removable media (e.g., disk, DVD, CD-ROM, tape,
CF/SD card, memory stick, etc.)? ............................................................................................................. Yes
D.4 Transmit/receive or import/export private data via dedicated cable connection (e.g., IEEE 1073, serial
port, USB, FireWire, etc.)? ........................................................................................................................ Yes 3
D.5 Transmit/receive private data via a wired network connection (e.g., LAN, WAN, VPN, intranet, Internet,
etc.)? ......................................................................................................................................................... Yes
D.6 Transmit/receive private data via an integrated wireless network connection (e.g., WiFi, Bluetooth,
infrared, etc.)? ........................................................................................................................................... No
D.7 Import private data via scanning? ........................................................................................................... No
D.8 Other? ....................................................................................................................................................... No
Private data are handled and stored in DICOM Format. You can refer to the DICOM Conformance Statement and
the link to the according internet page of Siemens Healthcare. http://www.healthcare.siemens.com/services/itstandards/
Management
dicom
of private
1) Biometric data can be created out of the MR DICOM data, e.g. facial recognition would be possible.
data notes:
2) Printer must be provided by customer.
3) Not required for intended use but possible.
3
© Copyright 2013 by the National Electrical Manufacturers Association and
the Healthcare Information and Management Systems Society.
HN 1-2013

SECURITY CAPABILITIES
Yes, No,
Note #
Refer to Section 2.3.2 of HIMSS/NEMA HN 1-2013 standard for the proper interpretation of information requested in
N/A, or
this form.
See Note
1 AUTOMATIC LOGOFF (ALOF)

The device's ability to prevent access and misuse by unauthorized users if device is left idle for a period of time.
1-1 Can the device be configured to force reauthorization of logged-in user(s) after a predetermined length of
inactivity (e.g., auto-logoff, session lock, password protected screen saver)? ................................................. Yes 1
1-1.1 Is the length of inactivity time before auto-logoff/screen lock user or administrator configurable?
(Indicate time [fixed or configurable range] in notes.) ........................................................................... Yes
1-1.2 Can auto-logoff/screen lock be manually invoked (e.g., via a shortcut key or proximity sensor, etc.) by
the user? .............................................................................................................................................. Yes
ALOF
1) Depends on the configuration settings.
notes:
2 AUDIT CONTROLS (AUDT)

The ability to reliably audit activity on the device.
2-1 Can the medical device create an audit trail? .................................................................................................. Yes 1
2-2 Indicate which of the following events are recorded in the audit log:
2-2.1 Login/logout ............................................................................................................................................. Yes
2-2.2 Display/presentation of data .................................................................................................................... Yes
2-2.3 Creation/modification/deletion of data ..................................................................................................... Yes
2-2.4 Import/export of data from removable media ......................................................................................... Yes
2-2.5 Receipt/transmission of data from/to external (e.g., network) connection ............................................... Yes
2-2.5.1 Remote service activity .......................................................................................................................... Yes
2-2.6 Other events? (describe in the notes section) ......................................................................................... Yes 2
2-3 Indicate what information is used to identify individual events recorded in the audit log:
2-3.1 User ID .................................................................................................................................................... Yes
2-3.2 Date/time ................................................................................................................................................. Yes
AUDT
1) Audit trails are created in the means of Windows.
notes:
2) With the syngo Security package additional events (e.g. all events with regard to PHI) will be logged.
3 AUTHORIZATION (AUTH)
The ability of the device to determine the authorization of users.
3-1 Can the device prevent access to unauthorized users through user login requirements or other mechanism? Yes
3-2 Can users be assigned different privilege levels within an application based on 'roles' (e.g., guests, regular
users, power users, administrators, etc.)? ......................................................................................................... Yes 1
3-3 Can the device owner/operator obtain unrestricted administrative privileges (e.g., access operating system or
application via local root or admin account)? ....................................................................................................... Yes 2
AUTH 1) Yes, if the syngo Security package is activated.
notes: 2) No access to safety relevant functionality.
4
HN 1-2013

Yes, No,
Note #
Refer to Section 2.3. of HIMSS/NEMA HN 1-2013 standard for the proper interpretation of information requested in
N/A, or
this form.
See Note
4 CONFIGURATION OF SECURITY FEATURES (CNFS)

The ability to configure/re-configure device security capabilities to meet users’ needs.
4-1 Can the device owner/operator reconfigure product security capabilities? .................................................... Yes 1
CNFS
1) Some configurations need to be performed by SIEMENS Service.
notes:
5 CYBER SECURITY PRODUCT UPGRADES (CSUP)

The ability of on-site service staff, remote service staff, or authorized customer staff to install/upgrade device's security
patches.
5-1 Can relevant OS and device security patches be applied to the device as they become available? ................ No 1
5-1.1 Can security patches or other software be installed remotely? ............................................................... Yes 2
1) Siemens monitors the available OS and system security patches and decides whether they are relevant for the
CSUP product. If yes, an accumulated service pack (SP) or security delivery (SD) is created and delivered to the
notes: customers.
2) Depending on Service Contract and size / content of the installation package.
6 HEALTH DATA DE-IDENTIFICATION (DIDT)
The ability of the device to directly remove information that allows identification of a person.
6-1 Does the device provide an integral capability to de-identify private data? ....................................................... Yes 1
DIDT 1) Focus of the anonymization is on the DICOM patient quadruple. Additional country specific legal requirements are
notes: not fulfilled yet.
7 DATA BACKUP AND DISASTER RECOVERY (DTBK)

The ability to recover after damage or destruction of device data, hardware, or software.
7-1 Does the device have an integral data backup capability (i.e., backup to remote storage or removable media
such as tape, disk)? ............................................................................................................................................. Yes 1
DTBK 1) Service data and configuration data can be backed up on HDD, CD-R or DVD-R by the service technician. Patient
notes: (image) data can be auto-transferred immediately after the MR exam (PACS).
8 EMERGENCY ACCESS (EMRG)

The ability of device users to access private data in case of an emergency situation that requires immediate access to
stored private data.
8-1 Does the device incorporate an emergency access (“break-glass”) feature? .................................................. No 1
EMRG
1) MR has no emergency mode.
notes:
9 HEALTH DATA INTEGRITY AND AUTHENTICITY (IGAU)

How the device ensures that data processed by the device has not been altered or destroyed in an unauthorized manner
and is from the originator.
9-1 Does the device ensure the integrity of stored data with implicit or explicit error detection/correction
technology? ......................................................................................................................................................... No 1
IGAU 1) The medical device is not intended to be used for patient data storage. Patient data should be transferred
notes: immediately to an appropriate archive.
5
HN 1-2013

Yes, No,
Note #
Refer to Section 2.3.2 of HIMSS/NEMA HN 1-2013 standard for the proper interpretation of information requested in
N/A, or
this form.
See Note
10 MALWARE DETECTION/PROTECTION (MLDP)

The ability of the device to effectively prevent, detect and remove malicious software (malware).
10-1 Does the device support the use of anti-malware software (or other anti-malware mechanism)? ................. Yes 1
10-1.1 Can the user independently re-configure anti-malware settings? ....................................................... No
10-1.2 Does notification of malware detection occur in the device user interface? ........................................ No
10-1.3 Can only manufacturer-authorized persons repair systems when malware has been detected? ........ Yes
10-2 Can the device owner install or update anti-virus software? .......................................................................... No
10-3 Can the device owner/operator (technically/physically) update virus definitions on manufacturer-installed anti-
virus software? ................................................................................................................................................ No 2
1) McAfee® Solidifier and Microsoft® EMET is used to protect the system.
MLDP
2) The protection of the system is based on Whitelisting and therefore no additional Anti Virus Software is part of the
notes:
System.
11 NODE AUTHENTICATION (NAUT)
The ability of the device to authenticate communication partners/nodes.
11-1 Does the device provide/support any means of node authentication that assures both the sender and the
recipient of data are known to each other and are authorized to receive transferred information? .................. No 1
NAUT
1) For remote service access (e.g. Siemens Remote Service) technical measures for node authentication are in place.
notes:
12 PERSON AUTHENTICATION (PAUT)

Ability of the device to authenticate users
12-1 Does the device support user/operator-specific username(s) and password(s) for at least one user? ........... Yes
12-1.1 Does the device support unique user/operator-specific IDs and passwords for multiple users? ................... Yes 1
12-2 Can the device be configured to authenticate users through an external authentication service (e.g., MS Active
Directory, NDS, LDAP, etc.)? .............................................................................................................................. No
12-3 Can the device be configured to lock out a user after a certain number of unsuccessful logon attempts? ....... Yes
12-4 Can default passwords be changed at/prior to installation? ................................................................................ Yes
12-5 Are any shared user IDs used in this system? .................................................................................................... Yes
12-6 Can the device be configured to enforce creation of user account passwords that meet established complexity
rules? ................................................................................................................................................................... Yes
12-7 Can the device be configured so that account passwords expire periodically? .................................................. Yes
PAUT
1) Optional syngo Security package needs to be activated.
notes:
13 PHYSICAL LOCKS (PLOK)

Physical locks can prevent unauthorized users with physical access to the device from compromising the integrity and
confidentiality of private data stored on the device or on removable media.
13-1 Are all device components maintaining private data (other than removable media) physically secure (i.e.,
cannot remove without tools)? ............................................................................................................................. No 1
PLOK
1) Customer can physically secure the device with very little effort
notes:
6
HN 1-2013

MAGNETOM Systems n.a. syngo MR E11 n.a.
Yes, No,
Note #
Refer to Section 2.3.2 of HIMSS/NEMA HN 1-2013 standard for the proper interpretation of information requested
N/A, or
in this form.
See Note
14 ROADMAP FOR THIRD PARTY COMPONENTS IN DEVICE LIFE CYCLE (RDMP)

Manufacturer’s plans for security support of 3rd party components within device life cycle.
14-1 In the notes section, list the provided or required (separately purchased and/or delivered) operating system(s)
- including version number(s). .......................................................................................................................... Yes 1
14-2 Is a list of other third party applications provided by the manufacturer available? ............................................ Yes 2
1) Windows 7 (64 bit) Embedded, Customized Linux (not visible for the customer network)
RDMP
2) Shortlist is part of the Security Whitepaper. Complete list can be provided on customer request. (on base of a non-
notes:
disclosure agreement)
15 SYSTEM AND APPLICATION HARDENING (SAHD)
The device's resistance to cyber attacks and malware.
15-1 Does the device employ any hardening measures? Please indicate in the notes the level of conformance to any
industry-recognized hardening standards. ........................................................................................................... Yes 1
15-2 Does the device employ any mechanism (e.g., release-specific hash key, checksums, etc.) to ensure the
installed program/update is the manufacturer-authorized program or software update? .................................... Yes
15-3 Does the device have external communication capability (e.g., network, modem, etc.)? ................................... Yes
15-4 Does the file system allow the implementation of file-level access controls (e.g., New Technology File System
(NTFS) for MS Windows platforms)? ................................................................................................................... Yes
15-5 Are all accounts which are not required for the intended use of the device disabled or deleted, for both users
and applications? ................................................................................................................................................. Yes
15-6 Are all shared resources (e.g., file shares) which are not required for the intended use of the device, disabled?
Yes
15-7 Are all communication ports which are not required for the intended use of the device closed/disabled? ....... Yes
15-8 Are all services (e.g., telnet, file transfer protocol [FTP], internet information server [IIS], etc.), which are not
required for the intended use of the device deleted/disabled? .......................................................................... Yes
15-9 Are all applications (COTS applications as well as OS-included applications, e.g., MS Internet Explorer, etc.)
which are not required for the intended use of the device deleted/disabled? ................................................... Yes
15-10 Can the device boot from uncontrolled or removable media (i.e., a source other than an internal drive or
memory component)? .......................................................................................................................................... Yes 2
15-11 Can software or hardware not authorized by the device manufacturer be installed on the device without the use
of tools? ............................................................................................................................................................... No
SAHD 1) DISA Secure Technical Implementation Guidelines (STIG)
notes: 2) Can be disabled on request.
16 SECURITY GUIDANCE (SGUD)

The availability of security guidance for operator and administrator of the system and manufacturer sales and service.
16-1 Are security-related features documented for the device user? ........................................................................... Yes
16-2 Are instructions available for device/media sanitization (i.e., instructions for how to achieve the permanent
deletion of personal or other sensitive data)? ....................................................................................................... Yes 1
SGUD
1) Siemens Service has instructions in place to support the customer during the device/media sanitization.
notes:
7
HN 1-2013

Yes, No,
Note #
Refer to Section 2.3.2 of HIMSS/NEMA HN 1-2013 standard for the proper interpretation of information
N/A, or
requested in this form.
See Note
17 HEALTH DATA STORAGE CONFIDENTIALITY (STCF)

The ability of the device to ensure unauthorized access does not compromise the integrity and confidentiality of private
data stored on device or removable media.
17-1 Can the device encrypt data at rest? ............................................................................................................... No 1
STCF
1) MR Systems are not designed for long time archiving of DICOM data.
notes:
18 TRANSMISSION CONFIDENTIALITY (TXCF)

The ability of the device to ensure the confidentiality of transmitted private data.
18-1 Can private data be transmitted only via a point-to-point dedicated cable? .................................................. No 1
18-2 Is private data encrypted prior to transmission via a network or removable media? (If yes, indicate in the
notes which encryption standard is implemented.) ......................................................................................... No 2
18-3 Is private data transmission restricted to a fixed list of network destinations? .............................................. Yes 3
1) Depends on the customer network design. In principle possible but not common.
TXCF 2) DICOM Encryption is supported and can be configured. Software based removable media encryption is not
notes: supported.
3) DICOM nodes are defined and identified using their IP address.
19 TRANSMISSION INTEGRITY (TXIG)
The ability of the device to ensure the integrity of transmitted private data.
19-1 Does the device support any mechanism intended to ensure data is not modified during transmission? (If
yes, describe in the notes section how this is achieved.) ............................................................................... Yes 1
TXIG
1) In the means of TCP/IP.
notes:
20 OTHER SECURITY CONSIDERATIONS (OTHR)

Additional security considerations/notes regarding medical device security.
20-1 Can the device be serviced remotely? ........................................................................................................... Yes

20-2 Can the device restrict remote access to/from specified devices or users or network locations (e.g., specific
IP addresses)? ................................................................................................................................................ Yes
20-2.1 Can the device be configured to require the local user to accept or initiate remote access? ........... Yes
OTHR
n.a.
notes:
8
MAGNETOM
MR
System Owner Manual
Product & Solution Security

Whitepaper
Aera
Avantofit
Prisma/Prismafit
Skyra/Skyrafit
Product & Solution Security Whitepaper
Foreword
The Siemens Healthineers product and solution  Performing static code analysis of medical
security program device software
At Siemens Healthineers, we are committed to  Conducting security testing of medical devices
working with you to address cybersecurity and under development as well as medical
privacy requirements. Our Product and Solution devices already in the field
Security Office is responsible for our global  Tailoring patch management to the medical
program that focuses on addressing device and depth of coverage chosen by you
cybersecurity throughout the product lifecycle  Monitoring security vulnerability to track
of our medical devices. reported third party components issues in our
medical devices
Our program targets incorporating state of the  Working with suppliers to address security
art cybersecurity in our current and future throughout the supply chain
products. We seek to protect the security of your  Training of employees to provide knowledge
data while, at the same time, providing consistent with their level of responsibilities
measures to strengthen the resiliency of our regarding your data and device integrity.
products from external cybersecurity attackers.
Contacting Siemens Healthineers about
We comply with applicable security and privacy product and solution security
regulations from the US Department of Health Siemens Healthineers requests that any
and Human Services (HHS), including the Food cybersecurity or privacy incidents are reported
and Drug Administration (FDA) and Office for by email to:
Civil Rights (OCR), to help you meet your IT productsecurity@siemens-healthineers.com
security and privacy obligations.
For all other communication with Siemens
Vulnerability and incident management Healthineers about product and solution
Siemens Healthineers cooperates with security:
government agencies and cybersecurity ProductTechnologyAssurance.dl@siemens-
researchers concerning reported potential healthineers.com
vulnerabilities.
Our communications policy strives for

coordinated disclosure.
We work in this way with our customers and
other parties, when appropriate, in response to
potential vulnerabilities and incidents in our
medical devices, no matter what the source.
Elements of our product and solution security

program
 Providing information to facilitate secure
configuration and use of our medical devices Jim Jacobson
in your IT environment Chief Product and Solution Security Officer
 Conducting formal threat and risk analysis Siemens Healthineers
for our medical devices
 Incorporating secure architecture, design and
coding methodologies in our software
development process
3
Network Information
The following image shows a high-level overview of the MR system and its integration into the hospital environment:
Equipment
Magnet Room
Room
Connection to
Siemens Remote machines physically not
MaRS accessible
Service
(OPTIONAL) located in a control cabinet
(technic room)
no USB
no PHI
pixels only
optional screen
CAN24 hidden network
in acquisition room no routing to Customer
network
Control Room
video
connection Acquisition Application
Shared Data Postprocessing Apps
Base Common syngo platform
PHI only on MRAW
syngo.via
MRWP (OPTIONAL) MRAW client syngo.via
Satellite Console Main Console server
DICOM DICOM
Customer Network
DICOM
The basic MR system is located in three different but adjacent rooms: The examination room, where the patient is
examined, the operator room, where the medical operators work, and the equipment room, where most of the control
hardware is installed.
Communication lines shown in red are Ethernet connections (TCP and UDP). Communication lines shown in black use
other internal protocols (CAN, PCIe, or proprietary protocols). The internal Ethernet connections between the MRAWP
and the MARS, and between the CAN24 and the MARS are not accessible from the hospital network.
It is assumed that the machine room is locked and not accessible to patients or non-authorized personnel. For
installations with elevated security requirements, it is recommended to make the operator room inaccessible to patients
and non-authorized persons as well.
4
Optional components:
 The hospital network and all components outside the MR systems are assumed to be under control of the
customer. Siemens makes no prescriptions about how to structure the network.
 The MRWP is an optional workstation for image inspection and post-processing. It could even be located in a
separate room. Information in the patient and image database located on the MRAWP is shared between the
MRAWP and the MRWP, i.e. sensitive information is transferred over the hospital network. For systems with
elevated security requirements it is recommended to either not using the MRWP, or to make sure that the
network communication between the MRAWP and the MRWP is secured.
 Siemens remote service is an optional feature. Without remote service, the router to the Siemens service center is
not needed.
 The CAN24 box is used to monitor the magnet status by remote service, even if the other system parts are
switched off. Without remote service, this cannot be done. The CAN24 is not optional; however, the connection
to the hospital network can be omitted.
Note: A network connection (e.g. hospital network) is not mandatory to operate MAGNETOM systems.
The MRWP requires one static IP addresses, which must be provided by the customer. The following ports can be used by
the system (depending on the configuration and installed options).
Port number Service/function Direction Protocol
80 Remote service (unencrypted) Inbound/outbound http

Not recommended; encrypted communication should be
preferred.
104 DICOM communication (unencrypted) Inbound/outbound DICOM
135 Windows Folder Sharing Inbound/outbound tcp
443 Remote service (encrypted) Inbound/outbound https
1801 Microsoft message queuing service Inbound/outbound tcp
1947 Sentinel LDK license manager Inbound/outbound http
2762 DICOM communication (encrypted) Inbound/outbound Secure DICOM
5800 VNC server for Expert-i remote collaboration (optional) Inbound/outbound tcp
5900 VNC server for Expert-i remote collaboration (optional) Inbound/outbound tcp
5901-5903 Expert-i remote collaboration (optional) Inbound/outbound tcp
8226-8228 Managed node package (only during file transfers from Inbound/outbound tcp
Siemens remote service)
5
Security Controls
Malware protection Physical protection

 Whitelisting (McAfee® Application Control) is installed  Customer is responsible for the physical protection of
with syngoMR E11 the MAGNETOM system and the operating consoles, e.g.
 Microsoft® EMET (Enhanced Mitigation Experience by securing the operator and equipment room with user
Toolkit) access control.
Data protection controls
Controlled use of administrative privileges  PHI is protected by role based access control. (optional
 The system distinguishes between clinical and syngo Security option)
administrative roles. Clinical users don’t require  The system provides auditing of PHI access. (optional
administrative privileges. Authorization as syngo Security option)
administrator is required for administrative tasks
Auditing/logging
Authentication authorization controls  HIPAA conform auditing of operations on PHI, PII and
 syngo MR E11 supports HIPAA (Health Insurance user information (i.e. login, read access PHI,
Portability and Accountability Act) regulation with role modification of PHI). (optional syngo Security option)
based privilege assignment and access control.  Event Logging in the means of Microsoft Windows is also
 syngo MR E11 supports by default a customer specific supported.
password to access the system. Please contact SIEMENS
service for configuration. Remote connectivity
 The system provides preconfigured Password Policies  Siemens Remote Service connection performed using
which can be customized by administrators secured channel. The channel is used e.g. to download
security patches and updates
Continuous vulnerability assessment and remediation
 Continuous Vulnerability Assessment and Remediation Incident response and management
is performed  Incident handling process is defined and being executed
on demand to deal with incidents.
Hardening
 syngo MR E11 hardening is performed based on the
Security Technical Implementation Guidelines
developed by Defense Information Systems Agency
(DISA)
Network controls
 The system is designed to make limited use of network
ports and protocols. Only ports and protocols which are
required for operation are open and utilized
 Microsoft® Windows firewall is configured to block
unwanted inbound network traffic except for above
mentioned ports
 Siemens Healthineers recommends operating the
system in a secured network environment, e.g. a
separate network segmented or a VLAN.
 Connection to the Internet or private networks for
patients/guests is not recommended
 In case of a denial of service (DoS) or malware attack,
the system can be taken off the network and operated
standalone
6
Software Bill of Materials
The following table lists comprises the most relevant third party technologies used.
Vendor name Component name Component version Description/use
Microsoft Windows 7 (64bit) Operating system

Microsoft .NET Framework 4.5.x .NET Environemnt
Microsoft EMET 5.5 Memory Protection
McAfee McAfee Solidifier 7.0.x Whitelisting / Virus Protection
Adobe Adobe Reader XI 11.x Report Viewer / Offline
Documentation
SIEMENS Managed Node Package VI40B Optional: Managed Node Package for
Smart Rempte Service (SRS)
SIEMENS SW HDVNC 8.2 Optional: Expert-I VNC Viewer
SIEMENS cRSP Teamviewer 1.0.x Teamviewer – Desktop Sharing for
Connector service technician
A complete list of installed 3rd party software can be provided on request.
7
Manufacturer Disclosure Statement
according to IEC60601-1
Statement according to IEC 60601-1, 3rd Edition, Chapter 14.13
1) Network properties required by the system and resulting risks
1-1. The device is connected via Ethernet cable to the hospital using a TCP/IP network with 1Gb/s.
• If the network is down the network services (see below) is not available which can lead to the risks
stated below.
• If the network is unavailable, medical images can not be transferred for remote consultation.
• If the recommended network performance (1Gbit/s) is not provided, the transfer of images is extended
and availability of images at destinations (e.g. for consulting) is delayed.
• Only the protocols shown in the table of used ports are needed for communication.
1-2. PACS system for archiving Images/Results
• If the PACS is not available, images can not be archived after the examination. In case of a system
hardware failure all not archived images can be lost.
• If the PACS is not available, images can not be archived after the examination. Examinations may be no
longer possible because the hard disk is full (because non-archived images can not be automatically
removed).
• If the PACS is not available, images can not be archived after the examination. In case of manual
deletion of images, not archived images can be lost.
• If the PACS is not available, images are not available for remote consultation via PACS consoles.
• If the PACS is not available, prior images are not available.
• If the recommended network performance (1Gbit/s) is not provided, the transfer time to PACS is
extended and the time to wait before switching off the System concecutive to last transfer operations is
prolonged.
1-3. DICOM Printer
• If the DICOM printer is not available, film is not available for diagnose/archive.
1-4. RIS System
• If the RIS system is not available, modality worklist is not available. This can lead to data
inconsistencies.
• If the RIS system is not available, modality worklist is not available. This can lead to images sent to the
PACS are possibly not available until manually coerced with the RIS data in the PACS.
• In case a reduced network performance shall be compensated by a long Worklist Query time-out, this
results in the possibility that non-actual RIS data are used when registering a patient from the list of
schedules on the System.
1-5. Network Connection to Siemens Remote Service Server
• If the connection to the Siemens Remote Service Server is not available, Virus pattern and SW patches
can not be distributed.
• If the connection to the Siemens Remote Service Server is not available, SIEMENS Support is restricted.
1-6. Common Medical protocol properties.
• Protocols used in medical environment are typically unsecure.
• Exceptions are Secure DICOM and Siemens Remote Service (using https).
8
2) Instructions for the responsible organization
2-1. Connection of the system to a NETWORK / DATA COUPLING that includes other equipment could result in previously
unidentified risks to patients operators or third parties. The RESPONSIBLE ORGANIZATION should identify, evaluate
and control these risks
2-2. Subsequent changes to the NETWORK / DATA COUPLING could introduce new RISKS and require additional analysis.
2-3. Changes to the network include:
• changes in NETWORK / DATA COUPLING configuration;
• connection to additional items to the NETWORK / DATA COUPLING;
• disconnecting items from the NETWORK / DATA COUPLING;
• update of equipment connected to the NETWORK / DATA COUPLING;
• upgrade of equipment connected to the NETWORK / DATA COUPLING;
2-4. The RESPONSIBLE ORGANIZATION is fully responsible for the security of the network the device is connected to.
2-5. The RESPONSIBLE ORGANIZATION is fully responsible to ensure staff with access to the device do not have the
possibility to provide any harm to the system.
2-6. The RESPONSIBLE ORGANIZATION has to ensure that the internal network can not be accessed phsysically by non
authorized persons.
2-7. Stuff of the RESPONSIBLE ORGANIZATION has to be trained in security. The RESPONSIBLE ORGANIZATION is
responsible to do this.
2-8. The RESPONSIBLE ORGANIZATION is fully responsible that only authorized medical/administrative staff shall have
access to the device.
2-9. The RESPONSIBLE ORGANIZATION is fully responsible that visitors/patients do not have unsupervised physical
access to the system.
2-10. The RESPONSIBLE ORGANIZATION shall provide access to the system for device administrators and device service
engineers
2-11. The RESPONSIBLE ORGANIZATION shall ensure that neither access from the public internet nor the public intranet to
the device is possible.
2-12. The RESPONSIBLE ORGANIZATION is responsible to ensure physical security for the device.
2-13. The RESPONSIBLE ORGANIZATION shall ensure that access to services of the device from other equipment is possible
only on a need to do basis. An adequate network topology with apropriat firewall settings shall be used.
2-14. The RESPONSIBLE ORGANIZATION is responsible for a secure infrastructure that makes it impossible to change,
prevent, tamper data in transit in any way.
2-15. RECOMMENDATION: It is higly recommende that the RESPONSIBLE ORGANIZATION monitors the network for
unusual traffic
3) Risks and hazardous situations
9
Disclaimer according to IEC 80001-1
1-1 The Device has the capability to be connected to a medical IT-network which is managed under full responsibility of
the operating responsible organization. It is assumed that the responsible organization assigns a Medical IT-Network Risk
Manager to perform IT-Risk Management (see IEC 80001- 1:2010/EN 80001-1:2011) for IT-networks incorporating medical
devices.
1-2 This statement describes Device-specific IT-networking safety and security capabilities. It is not a responsibility
agreement according to IEC 80001-1:2010/EN 80001-1:2011.
1-3 Any modification of the platform, the software or the interfaces of the Device - unless authorized and approved by
Siemens Healthcare GmbH Healthcare - voids all warranties, liabilities, assertions and contracts.
1-4 The responsible organization acknowledges that the Device’s underlying standard computer with operating system is
to some extent vulnerable to typical attacks like e.g. malware or denial-of-service.
1-5 Unintended consequences (like e.g. misuse/loss/corruption) of data not under control of the Device e.g. after electronic
communication from the Device to some IT-network or to some storage, are under the responsibility of the responsible
organization.
1-6 Unauthorized use of the external connections or storage media of the Device can cause hazards regarding the
availability and information security of all components of the medical IT-network. The responsible organization must
ensure – through technical and/or organizational measures - that only authorized use of the external connections and
storage media is permitted.
International Electrotechnical Commission Glossary (extract)

Responsible organization:
Entity accountable for the use and maintenance of a medical IT-network
10
Statement on FDA Cybersecurity
Guidance
Siemens Healthineers will follow cybersecurity guidance issued by the FDA as appropriate. Siemens Healthineers
recognizes the principle described in FDA cybersecurity guidance that an effective cybersecurity framework is a shared
responsibility among multiple stakeholders (e.g., medical device manufacturers, health care facilities, patients and
providers), and is committed to drawing on its innovation, engineering and pioneering skills in collective efforts designed
to prevent, detect and respond to new and emerging cybersecurity threats. While FDA cybersecurity guidance is
informative as to adopting a risk-based approach to addressing potential patient harm, it is not binding and alternative
approaches may be used to satisfy FDA regulatory requirements.
The representations contained in this whitepaper are designed to describe Siemens Healthineers’ approach to
cybersecurity of its medical devices and to disclose the security capabilities of the devices/systems described herein.
Neither Siemens Healthineers nor any medical device manufacturer can warrant that its systems will be invulnerable to
cyberattack. Siemens Healthineers makes no representation or warranty that its cybersecurity efforts will ensure that its
medical devices/systems will be error-free or secure against cyberattack.
11
12
Register
To help you organize your own documentation, the following
registers are provided:
Correspondence with authorities A
Certificates B
Software licenses and warranty C
Upgrades D
Room layout E
Modification level of components F
Declaration of conformity G
... H
... I
... J
Register

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MR compatibility data sheet 3

Guidance and manufacturer’s declaration EMC 4

Manufacturer Disclosure Statement for

Product & Solution Security Whitepaper 10

System Owner Manual

We wish you much success with your Siemens system.

3 MR compatibility data sheet

4 Guidance and manufacturer’s declaration EMC

9 Manufacturer Disclosure Statement for Medical Device Security – MDS2

10 Product & Solution Security Whitepaper

11 Correspondence with authorities

13 Software licenses and warranty

16 Revision level of components

Series certification of the entire system with all possible options.

1 Safety information for the system owner 5

MAGNETOM Family | syngo MR E11 3

4 Safety Information | System Owner Manual

1 Safety information for the

1.1.1 Common causes for accidents

1.1.3 Definitions of different persons

Term used Explanation

User/Operator/ Person who operates the system or software, takes care

System owner Person who is responsible for the MR environment. This

MR worker Person who works within the controlled access area or

MAGNETOM Family | syngo MR E11 5

Term used Explanation

Siemens Service/ Group of specially trained persons who are authorized by

1.2 Legal regulations

1.2.1 Country-specific regulations

1.2.2 National guidelines (for Germany)

1.2.3 Pressure Equipment Directive

1.2.4 Electromagnetic fields

6 Safety Information | System Owner Manual

Outside the controlled access area, electromagnetic interferences meet the

1.2.5 Noise development

1.2.7 Video monitoring

1.2.8 Combination of devices

Third-party devices connected to the MR system!

Any application of physiological monitoring and sensing devices to the patient is

MAGNETOM Family | syngo MR E11 7

Overload of circuit; water ingress; insufficient disconnection from the

Risk of electric shock

1.3 Emergency plans

1.3.1 Access to the examination room

RF door does not function as required!

8 Safety Information | System Owner Manual

1.3.2 Emergency procedures

MR scanning is not established for safe imaging of fetuses and infants

1.3.3 Quench emergency plan

Emergency situation with magnet quench!

The emergency plan should include the following information:

MAGNETOM Family | syngo MR E11 9

Due to such hazardous conditions as acute hypothermia and suffocation,

 room as well as adjacent rooms.

1.3.4 Fire fighting

 Only use fire extinguishers licensed for MR systems.

10 Safety Information | System Owner Manual

1.4 Employee qualifications/information

1.4.1 Informing MR workers

MAGNETOM Family | syngo MR E11 11

The operator should be particularly aware of:

Untrained or uninformed personnel!