Sensation System Owner Manual April 2009

This System Owner Manual is part of the multi-volume Operating Instructions for SOMATOM:

System Operator Manual

System Owner Manual

The named documents under “System Owner Manual” are legal partions.

Manufacturer’s note : This product bears a CE marking in accordance with the provisions of the Council Directive 93/42/EEC of June 14th, 1993 concerning medical devices. The CE marking applies only to medico-technical products/medical products introduced in connection with the above-mentioned comprehensive EC directives. The original language of this document is English.

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SOMATOM Sensation

Contents Introduction ...

1

•Notes on handling the System Owner Manual

Correspondence with authorities ...

2

•Files according to country-specific regulations

Declaration of conformity/ compatibility ...

3

•Series certification of the entire system with all possible options. •Standards and Statutory Regulations

Modification level of components ...

4

•List of the delivered components including hardware and software level

Technical data/Forms...

5

•Technical Specification •Dosimetry and Imaging Performance Report •Forms •Upgrades and additions •Performed updates

Certificates ...

6

•Installation certificates •System handover certificate •Customer instruction certificate •Constancy test certificate

Labeling ...

7

•Location of the labels

Room layout ...

8

•Practice and room drawings •Radiation protection drawings

Software licenses and warranty ...

9

•Software licenses including software warranty conditions

Preventive maintenance ...

10

•Maintenance plan •Safety Inspection •Maintenance contract

Updates...

11

•Performed updates

Disposal ...

12

•Notes on disposal of problematic substances

... ... ... Siemens AG Medical Solutions

04.07

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BHB-Contents-02

BHB-Contents-02

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Siemens AG Medical Solutions

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

System Owner

Siemens representative

Manufacturer

Medical Engineering

■ ■ ■

P.S.: The table on the following page shows which documents are filed in the System Owner Manual and who contributes the documents. All documents marked with " ▲ " are constituent parts of the Operator Manual.

Siemens AG Medical Solutions

04/2007

SOM Introduction-02

System Owner

Siemens representative

Manufacturer

Who supplies what? The documents in the System Owner Manual.

Document

1 Introduction ■

Notes on handling the System Owner Manual ■

Operator and location of the product

2 Correspondence with authorities ■

Files according to country-specific regulations

3 Declaration of conformity/compatibility ■

Series certification of the entire system with all possible options

▲

Standards and Statutory Regulations

4 Revision level of components ■

List of the delivered components including hardware and software level ■

Revision levels after component replacements

5 Technical data ▲

Technical specifications

▲

Dosimetry and Imaging Performance Report

▲

Forms ■ ■

Upgrades and additions Performed updates

6 Certificates ■

Installation certificates

■

System handover certificate ■

■

Customer instruction certificate Constancy test certificate

7 Labeling ▲

Location of the labels

8 Room layout ■

Practice and room drawings ■

Radiation protection drawings

9 Software licenses and warranty ■

Software licenses including software warranty conditions

10 Preventive maintenance ▲

Maintenance plan

■

Safety Inspection ■

Maintenance contract

■

Performed updates

■

Update the user documents and the technical documentation (if capable)

11 Updates

12 Disposal ▲

Notes on disposal of problematic substances

Siemens AG Medical Solutions

04/2007

SOM Introduction-02

SOMATOM Information on Medical Device (MP)

Siemens AG Wittelsbacherplatz 2 D-80333 Muenchen Germany Headquarters Siemens AG, Medical Solutions Henkestr. 127, D-91052 Erlangen Germany Telephone: +49 9131 84-0 www.siemens.com/healthcare Contact Address Siemens AG, Medical Solutions Computed Tomography Siemensstr. 1, D-91301 Forchheim Germany Telephone: +49 9191 18-0

© 2003-2008, Siemens AG Order No. C2-023.623.34.03.02 Printed in Germany 10/2008

Manufacturer’s note : This product bears a CE marking in accordance with the provisions of the Council Directive 93/42/EEC of June 14th, 1993 concerning medical devices. The CE marking applies only to medico-technical products/medical products introduced in connection with the above-mentioned comprehensive EC directives. The original language of this document is English.

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Information on Medical Device (MP)

Information on Medical Device General Information: according to §7, Sec.2 No.1 MP BetreibV (for Germany only)

Operator of system ... ... ...

Hospital/Clinic Name:

...

Address:

...

Street:

...

City:

...

Administration:

...

Location of system e.g. Building No.:

...

Floor No.:

...

Room No.: (operational assignment):

...

System type ... ...

Siemens representative Region

... ...

Regional representative (RC)

Start-up (DD-MM-YY)

...

Manufacturer/Supplier ...

Operator for the MP:

C2-023.623.34.03.02 10/2008

... see training protocol, chap. 6 Customer training protocol

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Information on Medical Device (MP)

System Owner Manual

System Overview: Component

Type designation

Mod. No.:

Ser. No.

Gantry Tube assembly Detector Note: ... ... ... ... ... ...

Documentation on functional tests and training § according to 5 Sec.1 MP BetreibV should be attached in chapter 6 of this System Owner Manual and can be found there.

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Information on Medical Device (MP)

System Owner Manual

Information on Medical Device (MP)

Training a) Authorized persons according to §5 Sec.. 1 No. 2 MP BetreibV

Date

Authorized person Name Signature

C2-023.623.34.03.02 10/2008

Person performing training Name Signature

5

Information on Medical Device (MP)

Date

6

Person performing training Name Signature

System Owner Manual

Authorized person Name Signature

Information on Medical Device (MP)

System Owner Manual

Information on Medical Device (MP)

Contracts Insofar as contracts exist for the performance of safety or metrological checks or maintenance measures, the name or company and address.

according to §5 Sec. 2 No. 5 MP BetreibV Persons or institution:

Name or company: ... Address: ... ... ...

Name or company: ... Address: ... ... ...

Name or company: ... Address: ... ... ...

Name or company: ... Address: ... ... ...

C2-023.623.34.03.02 10/2008

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Information on Medical Device (MP)

System Owner Manual

Name or company: ... Address: ... ... ...

Name or company: ... Address: ... ... ...

Name or company: ... Address: ... ... ...

Name or company: ... Address: ... ... ...

Name or company: ... Address: ... ... ...

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Information on Medical Device (MP)

System Owner Manual

Information on Medical Device (MP)

Malfunctions or repeated operational errors of the same type according to §7, Sec. 2, No. 6 MP BetreibV (for Germany only)

Date

Description of type and consequences

C2-023.623.34.03.02 10/2008

Name

9

Information on Medical Device (MP)

Date

10

Description of type and consequences

System Owner Manual

Name

Information on Medical Device (MP)

System Owner Manual

Information on Medical Device (MP)

Occurrences reportable to authorities and manufacturer The nomenclature for medical devices published by the "Deutschen Institut für medizinische Dokumentation und Information - DIMDI" (German Institute for Medical Documentation) should be used for descriptions when making entries. according to §7, Sec. 2, No. 7 MP BetreibV (for Germany only)

Date:

Description of occurrence

C2-023.623.34.03.02 10/2008

Reported to:

Name

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Information on Medical Device (MP)

Date:

12

Description of occurrence

System Owner Manual

Reported to:

Name

Information on Medical Device (MP)

SOMATOM Sensation Standards and Statutory Regulations Siemens BMed CTE ES VB 40 Thomas Kraus CTE ES GA

2002-2009 C2-023. CT English 01/2009 623.58.02.02 all CTE ES English VB 40

Siemens AG Wittelsbacherplatz 2 D-80333 Muenchen Germany Headquarters Siemens AG, Medical Solutions Henkestr. 127, D-91052 Erlangen Germany Telephone: +49 9131 84-0 www.siemens.com/healthcare Contact Address Siemens AG, Medical Solutions Computed Tomography Siemensstr. 1, D-91301 Forchheim Germany Telephone: +49 9191 18-0

© 2002-2009, Siemens AG Order No. C2-023.623.58.02.02 Printed in Germany 01/2009

Manufacturer’s note : This product bears a CE marking in accordance with the provisions of the Council Directive 93/42/EEC of June 14th, 1993 concerning medical devices. The CE marking applies only to medico-technical products/medical products introduced in connection with the above-mentioned comprehensive EC directives. The original language of this document is English.

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SOMATOM Sensation