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
syngo MR D13 0.0
www.siemens.com/healthcare

0.0
Manufacturer's notes: 0.0
This product bears a CE marking in accordance with the
provisions of regulation 93/42/EEC of June 14, 1993 for
medical products.
0.0
The CE marking applies only to medico-technical products/
medical products introduced in connection with the
above-mentioned comprehensive EC regulation.
0.0
0.0
0.0
0.0
0.0
0.0
0.0