Siemens MAGNETOM Skyra User manual

System Owner Manual
MAGNETOM
Skyra
© Siemens AG 2010–2012
All rights reserved
Siemens AG
Wittelsbacherplatz 2
80333 Muenchen
Germany
Contact Information:
Siemens AG
Healthcare Sector
Magnetic Resonance
Henkestrasse 127
91052 Erlangen
Germany
Telephone: [phone]
www.siemens.com/healthcare
Print No. M7-03002.629.06.03.24
AG 11/12

System Owner Manual
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
Correspondence with authorities 9
Certificates 10
Software licenses and warranty 11
Upgrades 12
Room layout 13
Modification level of components 14
Declaration of conformity 15

Siemens AG Healthcare Sector 11/12 Introduction – Page 1 of 4
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.
We wish you much success with your Siemens system.
Siemens AG
Healthcare Sector
P.S.: The table on the following page shows which documents are filed in the System Owner Manual
and who contributes the documents.
Manufacturer
Siemens
representative
System Owner
■
■
■

Siemens AG Healthcare Sector 11/12 Introduction – Page 2 of 4
Who supplies what? The documents in the System Owner Manual.
Manufacturer
Siemens
representative
System Owner
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
5Technicaldata
■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 Correspondence with authorities
■Files according to country-specific regulations
10 Certificates
■Installation certificate
■System handover certificate
■Customer instruction certificate
■Constancy test certificate
11 Software licenses and warranty
■Software licenses including software warranty conditions

Siemens AG Healthcare Sector 11/12 Introduction – Page 3 of 4
Who supplies what? The documents in the System Owner Manual.
Manufacturer
Siemens
representative
System Owner
Document
12 Updates
■Performed updates
13 Room layout
■Practice and room drawings
14 Revision level of components
■List of the delivered components including hardware and software level
■Revision levels after component replacements
15 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”.

Siemens AG Healthcare Sector 11/12 Introduction – Page 4 of 4

Siemens AG, Hea lthcare
MRsyngo MR D13dito! GmbHMAGNETOM FamilySafety InformationSystem Owner Manu alMR2010-2012MR-04009623130102n.a.EnglishEnglish06/2012n.a.n.a.syngo MR D13
MAGNETOM Family 0.0
System Owner Manual - Safety Information 0.0
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www.siemens.com/healthcare

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This product bears a CE marking in accordance with the
provisions of regulation 93/42/EEC of June 14, 1993 for
medical products.
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The CE marking applies only to medico-technical products/
medical products introduced in connection with the
above-mentioned comprehensive EC regulation.
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Safety instructions
A.1 Safety information for the system owner A.1-1
Preamble A.1-1
Legal regulations A.1-2
Emergency plans A.1-5
Emergency procedures A.1-6
Quench emergency plan A.1-7
Fire fighting A.1-9
Employee qualifications/information A.1-10
Pre-screening MR workers and patients A.1-14
Examination room and ambient conditions A.1-15
Air conditioning A.1-15
Magnetic fringe field and controlled access area A.1-16
Equipment room (MAGNETOM Verio) A.1-16
Signs and symbols A.1-17
Maintenance/repair A.1-20
Repairs and modifications A.1-21
Maintenance at regular intervals A.1-21

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Safety information for the system owner
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A.1
Safety information for the
system owner
A.1
Preamble A.1
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.
A.1
These include legal requirements, emergency plans, employee
information and qualifications, as well as requirements that
must be met in the examination room.
A.1
Common causes of acci-
dents
A.1
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 person-
nel, rescue personnel) must be informed about the special con-
ditions in the examination room. Magnetizable devices (e.g.
floor polishers, vacuum cleaners, wheelchairs, metal gurneys)
must not be used in the examination room.
A.1
◆Please note all safety instructions applicable to all users
which are described in the operator manual of the MR sys-
tem. (➡Operator manual MR system)

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Legal regulations A.1
Country-specific regulations A.1 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.
A.1
The local regulations also define the acceptable exposure limits
regarding noise as well as magnetic stray fields for users and
patients. (➡System Owner Manual: Technical data)
A.1
National guidelines
(for Germany)
A.1
The following regulations are in effect in Germany: A.1
■Medical Devices Act (MPG)
■Electromagnetic Device Compatibility Act (EMVG)
■Medical Device Operator Regulations (MPBetreibV)
■Accident Prevention Regulations (UVV)
If required, the RF source must be registered with local authori-
ties in accordance with national EMC guidelines.
A.1
Pressure Equipment Direc-
tive
A.1
The super-conductive magnet is classified as pressure equip-
ment. National guidelines for starting up and operating pres-
sure equipment must be observed.
A.1
In Europe, the Pressure Equipment Directive (97/23/EG) regu-
lates the sale of pressure devices.
A.1
In Germany, both the Pressure Equipment Directive as well as
the relevant Occupational Safety Regulations (BetrSichV) for
system start-up and operation apply.
A.1

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Electromagnetic fields A.1 The 0.5 mT line in the examination room defines the controlled
access area of the RF field. For controlling access to this area
adequate rules must be established. Therefore, regard the
potential risks from the attraction of magnetizable objects or
from torque on such materials. Also consider persons inadvert-
ently entering the area who may be affected by the possible dys-
function of their medical implants such as pacemakers.
A.1
Outside the controlled access area of the RF field, electromag-
netic interferences meet the requirements according to
IEC 60601-1-2.
A.1
Regarding the static magnetic field, your MR system is continu-
ously operated in the normal mode (means not more than
3.0 T). For China only: If the static magnetic field is higher than
2.0 T, the system is operated in the first level mode.
A.1
The limits of exposure of MR workers to static and time-varying
magnetic fields may be regulated by local laws. Special precau-
tions are necessary for pregnant MR workers, although no epi-
demiological 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. Furthermore, it may be required
in some countries that the “member of the public” limit is
applied to the fetus.
A.1
Noise development A.1 The exposure of MR workers to noise may be regulated by local
laws. The operator must ensure that the sound level at the oper-
ating console is limited in compliance with local rules for the
safety of the physician and the MR worker.
A.1
For MR equipment that produces noise louder than 99 dB(A),
the sound pressure level is measured according to NEMA MS 4.
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Laser A.1 The laser of the laser light localizer is classified as Class 2M
according to IEC 60825-1 (Class II according to US CDRH).
A.1
Video monitoring A.1 Labeling obligation may be regulated by local laws. The opera-
tor is responsible to comply with these laws if a video system is
installed.
A.1
Combination of devices A.1
A.1
Any application of physiological monitoring and sensing devices
to the patient is done under the exclusive direction and respon-
sibility of the system owner.
A.1
To generally test the proper operation of peripheral equipment,
a compatibility protocol is available. Manufacturers of periph-
eral equipment should use this Siemens compatibility protocol
to test the functionality of its equipment. (➡System Owner
Manual: Compatibility data sheet)
A.1
Installation A.1 Ensure that the multiple socket of the computers is not placed
on the floor.
A.1
A.1
Any combination to, or modifications of the system must
comply to the requirements of IEC 60601-1:2005 (chapter
16) and must be accepted from Siemens.
WARNING: To avoid the risk of electric shock, this equipment
must only be connected to a supply mains with protective
ground.

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A.1
Emergency plans A.1
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.
A.1
Access to the examination
room
A.1
Escape routes for the building must be established and well
marked. Escape routes must not be obstructed.
A.1
◆Establish measures on how to open the door in case of
patient is not accessible (e.g. the handle to the door
became defective).
◆Ensure that you have tools available to break the door open
in case of an emergency.
◆Ensure that a window in the examination room can be used
as an escape route in the case of an emergency.
A.1
A.1
WARNING A.1
RF door does not function as required!
It is not possible to freely access or leave the examina-
tion room in case of an emergency
◆Ensure that the RF door is checked and maintained reg-
ularly.

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Emergency procedures A.1
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 (e.g. the presence of a mag-
netic field).
A.1
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 med-
ical care as soon as possible.
A.1
Especially endangered
patients and MR workers
A.1
As special precautionary measures, a program for medical
supervision as well as 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:
A.1
■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 rea-
sons
■Children
A.1
MR scanning has not been established as safe for imaging
fetuses and infants less than two years of age. The responsi-
ble physician must evaluate the benefits of the MR examina-
tion compared to those of other imaging procedures.

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A.1
Quench emergency plan A.1
It is strongly recommended that the system owner establishes
an emergency plan in case gaseous helium escapes into the
examination room.
A.1
The emergency plan should include the following information: A.1
■Rescue scenarios that can be practiced with personnel
■Room-related conditions
■Rescue personnel (safety personnel, paramedics and fire-
men)
Quench
A.1 During a quench, the super-conductivity of the magnet is sus-
pended. The energy of the magnetic field is converted into heat.
The magnet field strength falls off to 20 mT within approx.
20 seconds. The liquid helium (coolant) boils off during this pro-
cess and is released to the outside via the exhaust vent line. The
escape of gaseous helium via the exhaust line is rather noisy
(hissing, gurgling).
A.1
A quench may occur as follows: A.1
■Start-up of the MR system (ramping up or filling the mag-
net)
■An accident (earthquake, fire, etc.)
■Spontaneously without any obvious external reason (highly
unusual)

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Defective vent line A.1 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 haz-
ardous situations may arise:
A.1
■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)
A.1
Due to such hazardous conditions as acute hypothermia and
suffocation, rescue attempts must be performed by at least
two persons.
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 by helium.
An emergency plan must be established to ensure correct
conduct under such hazardous conditions.