SOMATOM CT systems

 
System Owner Manual – Addendum

siemens-healthineers.com
 Legend

Legend
Indicates a hint
Is used to provide information on how to avoid operating errors or informa‐
tion emphasizing important details

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Is used to provide troubleshooting information or answers to frequently
asked questions

Indicates a list item

Indicates a prerequisite
Is used for a condition that has to be fulfilled before starting a particular
operation

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Italic Is used for references and for table or figure titles

Is used to identify a link to related information as well as previous or next

steps

Bold Is used to identify window titles, menu items, function names, buttons, and
keys, for example, the Save button
Is used for on-screen output of the system including code-related elements
or commands

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CAUTION
&$87,21
Used with the safety alert symbol, indicates a hazardous situation which, if
not avoided, could result in minor or moderate injury or material damage.
CAUTION consists of the following elements:
• Information about the nature of a hazardous situation
• Consequences of not avoiding a hazardous situation
• Methods of avoiding a hazardous situation

WARNING
:$51,1*
Indicates a hazardous situation which, if not avoided, could result in death
or serious injury.
WARNING consists of the following elements:
• Information about the nature of a hazardous situation
• Consequences of not avoiding a hazardous situation
• Methods of avoiding a hazardous situation

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 Table of contents

1 Addendum to System Owner Manual 5

1.1 Safety information 5
1.1.1 General safety information 6
1.1.2 Residual risk 7
1.2 Technical specification 7
1.3 Technical description 8
1.3.1 Dimensions 8
1.4 Location of labels 9
1.4.1 Image systems 10

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1 Addendum to System Owner

Manual
Dear customer,

Your SOMATOM CT system is delivered with up-to-date documents. However,

some modifications that are not yet listed in your System Owner Manual may
also apply to your system.
To keep your documents up-to-date regarding official inspections, you have to
insert this addendum in chapter 11 of your System Owner Manual.

This information applies to the following CT systems:

• SOMATOM Spirit

• SOMATOM Emotion

• SOMATOM Perspective

• SOMATOM Scope

Applicability

This manual is valid only in conjunction with the SOMATOM System Owner
Manual.

The availability of the components depends on your system configuration.

1.1 Safety information

Follow the safety information in this document.

To ensure the safe use of your product and the safety of people, you must
adhere to the safety information provided in the Instructions for use
documents. In addition, also observe your country-specific regulations and
guidelines.

Safety information is located in the safety section and repeated within context
where a hazardous situation may occur. To make sure safety information is
understood, always read it in context of the situation.

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WARNING and CAUTION are highlighted in the text:

:$51,1* Indicates a hazardous situation which, if not avoided, could result in

death or serious injury.

&$87,21 Indicates a hazardous situation which, if not avoided, could result in

minor or moderate injury.

WARNING and CAUTION have the same structure. The following example
CAUTION instructs you how to read a WARNING or a CAUTION:

CAUTION

This text describes the hazardous situation: Images with lossy

compression are used for diagnosis!
This text describes the hazard: Wrong diagnosis.
◆ This text describes how to avoid the hazardous situation: Always
verify your evaluation results with the original DICOM images (first
reader duty).
◆ Never use lossy ...

1.1.1 General safety information

For the secure operation of your device, it is the responsibility of the system
owner to ensure that each person who operates the system reads and
understands the provided Instructions for Use.

The Instructions for Use may contain the mention of medical device, in
particular within the Safety section. These safety instructions are nonetheless
still vaild for your device.

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CAUTION

Not observing the Instructions for Use and the safety information of the
medical device and the equipment!

Injury to the patient or personnel, and damage to the equipment.

◆ Always observe the Instructions for Use of the particular units used.
This includes the labels applied on the equipment as well as the
Instructions for Use documents.
◆ Always use this Instructions for Use document in conjunction with all
Instructions for Use documents provided.
◆ Follow the safety instructions and safety signs.
◆ For references purposes, store the Instructions for Use near your
workplace.

Electronic Instructions for Use are provided on your CT system and on the
workplace.

1.1.2 Residual risk

The residual risk has been judged as being acceptable. User-relevant safety
information is provided in the Instructions for Use documents of the medical
device.

1.2 Technical specification

Recon speed and IRS main storage are defined in the Technical specification,
which is part of the System Owner Manual.

Product Recon speed IRS main storage

SOMATOM Spirit Spirit 5 images/s 128 GB

SOMATOM Emotion 6-slice 6 images/s 140 GB (at least 5500 scan sec.)

*) optional

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Product Recon speed IRS main storage

8 images/s
16-slice 350 GB (at least 5100 scan sec.)
16 images/s*

650 GB
(at least 2500 scan sec.)
128-slice and 64-slice 20 images/s 830 GB
SOMATOM Perspec‐
1600 GB (at least 6000 scan sec.)
tive
650 GB
32-slice and 16-slice 20 images/s (at least 9900 scan sec.)
830 GB

8 images/s 365 GB (at least 5300 scan sec.)

Scope and Scope
SOMATOM Scope 10 images/s
Power
650 GB (at least 9000 scan sec.)
20 images/s*

*) optional

1.3 Technical description

Dimensions are defined in the Technical description, which is part of the System
Owner Manual.

1.3.1 Dimensions
Image reconstruction Height ≤ 500 mm
system
Width ≤ 255 mm

Depth ≤ 805 mm

Weight ≤ 31 kg

Image control system Height ≤ 430 mm

Width ≤ 190 mm

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Depth ≤ 490 mm

Weight ≤ 30 kg

Image evaluation system Height ≤ 430 mm

Width ≤ 190 mm

Depth ≤ 490 mm

Weight ≤ 30 kg

1.4 Location of labels

Image systems are defined in the Location of labels, which is part of the System
Owner Manual.

The pictures of the components shown here are only examples. The
appearance of your components depends on the system configuration.

The numbers and parameters on the labels shown in CT customer

documentation are examples only. For further questions, always refer to the
original labels that are mounted on the CT system and system components.

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1.4.1 Image systems

Image reconstruction
system

—or—

—or—

(1) Distributor identification label

—or—

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—or—

(2) Manufacturer identification label

Label layout may vary.

(3) Product status label

(4) Warning label of electric shock

Caution: Risk of electric shock.
Do not remove cover (or back).
Referring servicing to qualified service personnel.

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—or—

—or—

(1) Manufacturer identification label

(2) Warning label

Caution: Risk of electric shock.
Do not remove cover (or back).
Referring servicing to qualified service personnel.

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Image control system ⁄

Image evaluation system

—or—

—or—

(1) Distributor identification label

—or—

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—or—

(2) Manufacturer identification label

Label layout may vary.

(3) Product status label

(4) Warning label of electric shock

Caution: Risk of electric shock.
Do not remove cover (or back).
Referring servicing to qualified service personnel.

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Caution: Federal law restricts this device to sale by or on The original language of this document is English.
the order of a physician, dentist, or veterinarian (21 CFR
801.109(b)(1)).

Siemens Healthineers Legal Manufacturer

Headquarters Siemens Healthcare GmbH
Siemens Healthcare GmbH Henkestr. 127
Henkestr. 127 91052 Erlangen
91052 Erlangen Germany
Germany
Phone: +49 9131 84-0
siemens-healthineers.com

Published by Siemens Healthcare GmbH / Print No. HC-C2-068-G.623.02.06.02 / © Siemens Healthcare GmbH, 2016 - 2021
Date of first issue: 2016-05 / Revision date: 2021-01